[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Proposed Rules]
[Pages 50442-50677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15576]
[[Page 50441]]
-----------------------------------------------------------------------
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: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher (301) 415-5905; e-mail
[email protected].
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland, between 7:30 A.M. and 4:15 P.M. on Federal workdays.
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
You may submit comments on the information collections by the
methods indicated in the Paperwork Reduction Act Statement.
Publicly available documents related to this rulemaking may be
examined and copied for a fee at the NRC's Public Document Room (PDR),
Public File Area O1-F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland. Copyrighted documents may be viewed at the NRC's
PDR, but may not be copied. The draft Regulatory Analysis and other
documents related to this rulemaking, including comments can be viewed
and downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, 301-415-4737 or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Rebecca L. Karas, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, telephone (301) 415-3711, Timothy S. McCune, Office of
Nuclear Security and Incident Response, telephone (301) 415-6474, or
Dr. David R. Desaulniers, Office of Nuclear Reactor Regulation,
telephone (301) 415-1043. All of the above contacts may also be reached
by e-mail to [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Drug and Alcohol Testing Provisions, and General Fitness-for-
Duty Program Provisions
B. Work Fatigue Provisions
C. Combined Part 26 Rulemaking
II. Petitions and Request for Exemption
A. Petition for Rulemaking PRM-26-1
B. Petition for Rulemaking PRM-26-2
C. Request for Exemption under 10 CFR 26.6
III. Abbreviations
IV. Discussion of Proposed Action
A. Overview
B. Goals of the Rulemaking Activity
C. Overview of Proposed Rule
D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
V. Summary of Public Interactions and Comments
A. Public Comments Submitted to OMB on 2000 Final Rule and
Responses
B. Key Stakeholder Comments not Incorporated into Proposed Rule
and Responses
VI. Section-by-Section Analysis of Substantive Changes
VII. Issues for Public Comment
VIII. Criminal Penalties
IX. Agreement State Compatibility
X. Plain Language
XI. Voluntary Consensus Standards
XII. Finding of No Significant Environmental Impact: Environmental
Assessment
XIII. Paperwork Reduction Act Statement
XIV. Regulatory Analysis
A. Aggregate Analysis
B. Screening Review for Disaggregation
C. Disaggregation of Worker Fatigue Provisions
XV. Regulatory Flexibility Act Certification
XVI. Backfit Analysis
A. Consideration of Fuel Fabrication Facilities and Gaseous
Diffusion Plants
B. Aggregate Backfit Analysis
C. Screening Review for Disaggregation
XVII. References
I. Background
A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty
Program Provisions
On June 7, 1989, the Commission announced the adoption of a new
rule, 10 CFR Part 26, Fitness for Duty Programs (54 FR 24468), that
required each licensee authorized to operate or construct a nuclear
power reactor to implement a FFD program for all
[[Page 50443]]
personnel having unescorted access to the protected area of its plant.
A subsequent final rule published in the Federal Register on June 3,
1993, (58 FR 31467) expanded the scope of Part 26 to include licensees
authorized to possess, use, or transport formula quantities of
Strategic Special Nuclear Materials (SSNM).
At the time the FFD rule was published in 1989, the Commission
directed the NRC staff to continue to analyze licensee programs, assess
the effectiveness of the rule, and recommend appropriate improvements
or changes. The NRC staff reviewed information from several sources
including inspections, periodic reports by licensees on FFD program
performance, reports of significant FFD events, industry sponsored
meetings and current literature, as well as initiatives by industry,
the Substance Abuse and Mental Health Services Administration (SAMHSA,
formerly the National Institute on Drug Abuse [NIDA]) and SAMHSA's Drug
Testing Advisory Board, and recommended improvements and changes.
As a result, the NRC published proposed amendments to the FFD rule
in the Federal Register on May 9, 1996 (61 FR 21105). The 90-day public
comment period for the proposed rulemaking closed on August 7, 1996.
The NRC staff reviewed and considered public comments on the proposed
rule, and submitted a final rule to the Commission in a Commission
paper (SECY-00-0159), dated July 26, 2000. The Commission affirmed the
rule in a Staff Requirements Memorandum (SRM-M001204A) dated December
4, 2000. The affirmed rule was sent to the Office of Management and
Budget (OMB) to obtain a clearance under the Paperwork Reduction Act.
The request for comments on the clearance was published in the Federal
Register on February 2, 2001 (66 FR 8812). OMB and NRC received public
comments that objected to some aspects of the rule (responses to those
comments are included in Section V of this document). In SECY-01-0134,
dated July 23, 2001, the NRC staff recommended withdrawing the request
for clearance and preparing a new proposed rule. In a Staff
Requirements Memorandum (SRM-SECY-01-0134) dated October 3, 2001, the
Commission approved the staff's recommendation to withdraw the request
for clearance and prepare a new proposed rule.
B. Worker Fatigue Provisions
The NRC's ``Policy on Factors Causing Fatigue of Operating
Personnel at Nuclear Reactors'' (referred to in this document as NRC's
Policy on Worker Fatigue) was first published in the Federal Register
on February 18, 1982, (47 FR 7352), and later issued through Generic
Letter (GL) 82-12, ``Nuclear Power Plant Staff Working Hours,'' on June
15, 1982 (referred to in this document as GL 82-12). In GL 82-12, the
NRC requested licensees to revise the administrative section of their
technical specifications to ensure that plant administrative procedures
were consistent with the revised work-hour guidelines. Those guidelines
were:
(1) An individual should not be permitted to work more than 16
hours straight (excluding shift turnover time);
(2) An individual should not be permitted to work more than 16
hours in any 24-hour period, nor more than 24 hours in any 48-hour
period, nor more than 72 hours in any seven day period (all excluding
shift turnover time);
(3) A break of at least 8 hours should be allowed between work
periods (including shift turnover time); and
(4) Except during extended shutdown periods, the use of overtime
should be considered on an individual basis and not for the entire
staff on a shift.
Further, the guidelines permitted deviations from these limits in
very unusual circumstances if authorized by the plant manager, his
deputy, or higher levels of management. The NRC's Policy on Worker
Fatigue was incorporated, directly or by reference, and with variations
in wording and detail, into the technical specifications of all but
three nuclear power plant sites, who implemented the concept using
other administrative controls.
When 10 CFR part 26 was issued on June 7, 1989 (54 FR 24468), it
focused on establishing requirements for preventing and detecting
personnel impairment from drugs and alcohol. However, consistent with
SRM-SECY-88-129, dated July 18, 1988, several requirements addressed
other causes of impairment, including fatigue. Those requirements
included general performance objectives [Sec. 26.10(a) and (b)] that
provided for ``* * * reasonable assurance that nuclear power plant
personnel * * * are not under the influence of any substance, legal or
illegal, or mentally or physically impaired from any cause * * *'' and
``* * * early detection of persons who are not fit to perform
activities within the scope of this part * * * '' A requirement was
also included in Sec. 26.20(a) for licensee policies to ``* * *
address other factors that could affect fitness for duty such as mental
stress, fatigue and illness.''
In a letter dated February 25, 1999, Congressmen Dingell, Klink,
and Markey expressed concerns to former NRC Chairman Shirley Ann
Jackson that low staffing levels and excessive overtime may present a
serious safety hazard at some commercial nuclear power plants. The
Union of Concerned Scientists (UCS) expressed similar concerns on March
18, 1999, in a letter from David Lochbaum to Chairman Jackson, and in
the UCS report ``Overtime and Staffing Problems in the Commercial
Nuclear Power Industry,'' dated March 1999. In a letter dated May 18,
1999, to the Congressmen, the Chairman stated that the NRC staff would
assess the need to revise the policy.
Soon thereafter, the Commission received a petition for rulemaking
(PRM-26-2), dated September 28, 1999, from Barry Quigley. (The petition
is discussed in greater detail in Section II. B.) The petition
requested that the NRC amend 10 CFR Parts 26 and 55 to establish clear
and enforceable work hour limits to mitigate the effects of fatigue for
nuclear power plant personnel performing safety-related work.
The UCS petitioned the NRC on April 24, 2001, pursuant to 10 CFR
2.206, to issue a Demand for Information (DFI) to specified licensees.
The petition asserted that Wackenhut Corporation has the contractual
right to fire security guards who refuse to report for mandatory
overtime, and that this contractual right conflicts with 10 CFR Part
26. The NRC denied the DFI (ADAMS Accession No. ML013230169), but
addressed the concerns of the petition through the NRC's generic
communication process. On May 10, 2002, the NRC issued NRC Regulatory
Issue Summary (RIS) 2002-07: ``Clarification of NRC Requirements
Applicable to Worker Fatigue and Self-Declarations of Fitness-for-
Duty.'' The RIS addressed the applicability of 10 CFR Part 26 to worker
fatigue, the potential for sanctions related to worker FFD concerns to
have adverse implications for maintaining a work environment conducive
to reporting FFD concerns, and the protections afforded workers by 10
CFR 50.7, ``Employee Protection.''
On January 10, 2002, in SRM-SECY-01-0113, the Commission approved a
rulemaking plan, Fatigue of Workers at Nuclear Power Plants, dated June
22, 2001 (referred to in this document as SECY-01-0113). In accordance
with the approved plan, the NRC initiated a rulemaking to incorporate
fatigue management into 10 CFR Part 26 in order to strengthen the
effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue
[[Page 50444]]
adversely affecting public health and safety and the common defense and
security by establishing clear and enforceable requirements for the
management worker fatigue.
During the development of proposed fatigue management requirements,
the NRC observed an increase in concerns (e.g, allegations, media and
public stakeholder reports) related to the workload and fatigue of
security personnel following the terrorist attacks of September 11,
2001. Following an NRC review of the control of work hours for security
force personnel, and public interactions with stakeholders, the
Commission issued Order EA-03-038 on April 29, 2003, requiring
compensatory measures related to fitness-for-duty enhancements for
security personnel at nuclear power plants, including work hour limits.
The compensatory measures imposed by Order EA-03-038 were similar
to the guidelines of the NRC's Policy on Worker Fatigue. The
compensatory measures differed from the Policy guidelines in a few
areas in which the NRC believed it was necessary to address previously
identified deficiencies in the guidelines, including the need to
address cumulative fatigue from prolonged use of extended work hours,
matters unique to security personnel, and stakeholder input obtained
through public meetings concerning the proposed worker fatigue
rulemaking and the Order. The requirements in the Order were imposed to
provide the Commission with reasonable assurance that the public health
and safety and common defense and security continue to be adequately
protected. The provisions specified in proposed 10 CFR Part 26, Subpart
I, Managing Fatigue, for security force personnel would replace the
requirements imposed by Order. Differences between the proposed
requirements in Subpart I and the requirements imposed by Order, and
the rationale for those differences, are discussed in Section IV. D.
C. Combined Part 26 Rulemaking
On March 29, 2004, in COMSECY-04-0014, the NRC staff informed the
Commission of the status of both rulemaking activities. The NRC staff
also noted that because both rulemaking activities were being completed
in parallel, the draft proposed fatigue rule language was based on the
draft language in the proposed overall revision to Part 26, rather than
on the current language in Part 26. Therefore, meaningful public
comment could be confounded by the simultaneous promulgation of two
draft rules which are somewhat interdependent, and staff action to
address a comment on one proposed rule could easily impact the other
proposed rule, creating a high potential for the need to repropose one
or both rules. In SRM-COMSECY-04-0014, dated May 25, 2004, the
Commission directed the staff to combine the rulemaking related to
nuclear power plant worker fatigue with the ongoing Part 26 rulemaking
activity. This combined proposed rule withdraws the proposed rule
published on May 9, 1996.
II. Petitions and Request for Exemption
A. Petition for Rulemaking PRM-26-1
On December 30, 1993, Virginia Electric and Power Company (now
Dominion Virginia Power) submitted a Petition for Rulemaking (PRM-26-1)
requesting relaxation of the required 1-year audit frequency of the FFD
program and of licensee FFD programs and the program elements of
contractors and vendors (C/Vs) that are relied upon by licensees. The
petition requested that the first sentence of 10 CFR 26.80(a) be
amended to read:
``Each licensee subject to this Part shall audit the fitness-for-
duty program nominally every 24 months * * * In addition, audits must
be conducted, nominally every 24 months, of those portions of fitness-
for-duty programs implemented by contractors and vendors * * *''
In a letter dated March 14, 1994, the NRC informed the petitioner
that the petition would be addressed in a proposed rulemaking that was
under development. The NRC has periodically communicated with the
petitioner regarding the status of this rulemaking since that time.
Proposed Sec. 26.41(b) would partially grant two aspects of the
petition. That is, the required audit frequency for licensees and other
entities who are subject to 10 CFR Part 26 would be reduced from the
nominal 1-year frequency in the current rule to a nominal 2-year
frequency. Further, audits of C/V services that are performed on site
and under the direct daily supervision or observation of licensee
personnel would be conducted as part of the 2-year audits of the
licensee or other entity's FFD program, under proposed Sec. 26.41(b).
Proposed Sec. 26.41(c)(1) would partially deny two aspects of the
petition. That is, the nominal annual audit requirement for HHS-
certified laboratories would be retained. In addition, the annual audit
requirement would be retained for FFD program elements provided by C/Vs
whose personnel ``* * * are off site or are not under the direct daily
supervision or observation of licensee personnel * * *''
The bases for these changes to audit requirements in the proposed
rule are addressed in the subsequent sections of this supplementary
information.
B. Petition for Rulemaking PRM-26-2
On September 28, 1999, Barry Quigley submitted a Petition for
Rulemaking (PRM-26-2) requesting that the NRC amend 10 CFR Parts 26 and
55 to establish clear and enforceable work hour limits to mitigate the
effects of fatigue for nuclear power plant personnel performing safety-
related work. The PRM was published for public comment on December 1,
1999, (64 FR 67202). As described in Attachment 3 to SECY-01-0113, the
petition requested the NRC to:
(1) Add enforceable working hour limits to 10 CFR Part 26;
(2) Add a criterion to 10 CFR 55.33(a)(1) to require evaluation of
known sleeping disorders;
(3) Revise the NRC Enforcement Policy to include examples of
working hour violations that warrant various NRC sanctions; and
(4) Revise NRC Form 396 to include self-disclosure of sleeping
disorders by licensed operators.
The NRC received 176 comment letters in response to the petition.
The majority of the comments (157) were in favor of a rule. These
comments were principally from individuals and public interest groups.
Comments received from licensees, the Nuclear Energy Institute (NEI)
and Winston and Strawn, a law firm representing several utilities, were
opposed to PRM-26-2. A summary of the comments and responses is
available in SECY-01-0113 as Attachment 2. This document may be
obtained from the NRC's Web site, http://www.nrc.gov, by selecting the
electronic reading room and then collections of documents by type. It
is also available in the NRC's Agencywide Documentation and Management
System (ADAMS) under Package Accession Number ML010180224.
Although the NRC received many comments concerning the specific
requirements proposed in PRM-26-2, in general, letters in support of
the rulemaking--
(1) Cited the importance of ensuring that personnel who perform
safety-related functions are not impaired by fatigue;
(2) Expressed concern that the NRC does not have a regulation
limiting working hours and the perception that the NRC lacks the
authority to enforce
[[Page 50445]]
the guidelines in the NRC's Policy on Worker Fatigue;
(3) Asserted that the guidelines are ambiguous and that licensees
interpret the guidelines as not applicable when the plant is in an
outage;
(4) Asserted that ``the NRC appears to look the other way'' when
licensee work scheduling practices appear inconsistent with the
guidelines; and
(5) Expressed the concern that utility restructuring and cost
competition will cause reductions in staffing levels and increased
working hours and fatigue.
Further, several commenters noted that the Federal Government has
established work hour limits for personnel in other industries and
suggested that similar limits should apply to nuclear power plant
workers.
In general, comments that opposed the petition expressed the
opinion that existing regulatory requirements (i.e., technical
specifications and 10 CFR Part 26) are adequate to ensure that
personnel are not impaired by fatigue, that the proposed requirements
would impose an unnecessary and excessive burden that could not be
justified through a backfit analysis, and that industry performance
data refute the petitioner's argument that a rule is necessary to
prevent fatigued personnel from performing safety-related work.
The NRC has evaluated the merits of PRM-26-2, the comments received
in response to the PRM, and assessed the Policy on Worker Fatigue. The
NRC has concluded that the petitioner proposed a comprehensive set of
requirements that could reasonably be expected to effectively address
fatigue from individual and programmatic causes. However, the NRC
believes that it is possible to achieve these objectives through
alternative requirements that are more flexible, more directly focused
on risk, and more aligned and integrated with current regulatory
requirements. The proposed rule would therefore grant, in part, PRM-26-
2. A detailed discussion of the principal findings that led to the
decision to grant, in part, PRM-26-2 through rulemaking are included in
Section IV. D. of this document. In addition, for item 3 of PRM-26-2,
the NRC revised Inspection Procedure (IP) 71130.08, ``Fitness For Duty
Programs'' on February 19, 2004, to reflect the requirements of Order
EA-03-038, dated April 29, 2003, which required compensatory measures
related to fitness-for-duty enhancements for security personnel at
nuclear power plants, including work hour limits. The NRC plans to
similarly revise the same documents during preparation of the final
Part 26 rule. The self-disclosure of sleeping disorders by licensed
operators (item 4) is being addressed by the NRC as a separate effort
from this proposed rule through changes to Regulatory Guide 1.134,
``Medical Evaluation of Licensed Personnel at Nuclear Power Plants.''
C. Request for Exemption under 10 CFR 26.6
The current rule requires random drug and alcohol testing for
personnel with unescorted access to the protected area of a nuclear
power plant. By letter dated March 13, 1990, the International
Brotherhood of Electrical Workers (IBEW) Local 1245 requested an
exemption from random testing for clerical, warehouse, and maintenance
workers at the Diablo Canyon Nuclear Power Plant (Diablo Canyon) under
the provisions of 10 CFR 26.6. The NRC denied the request and IBEW
Local 1245 sought judicial review. In 1992, the Ninth Circuit Court of
Appeals affirmed the NRC's denial of the request (IBEW, Local 1245 v.
NRC, No. 90-70647, 9th Cir., June 11, 1992). In its opinion, the court
said that random testing may well be impermissible for clerical workers
at Diablo Canyon who perform no safety-sensitive work and have no
access to vital areas. However, in the record before the court at that
time, IBEW Local 1245 had not established that such a group existed. On
January 26 and December 6, 1993, IBEW Local 1245 renewed its request
for exemption, specifically asking that the NRC exempt from 10 CFR Part
26 requirements for random drug testing, clerical employees at Diablo
Canyon who are members of Local 1245 of the IBEW and who have
unescorted access to the protected area (PA) only, but not to the
radiologically controlled areas (RCAs) or vital areas (VAs) and who are
not required to staff the plant's emergency response center (ERC). The
PA is the area inside the security fence of a nuclear power plant,
which surrounds the entire plant, and the immediately surrounding area,
whereas the VAs enclose key safety systems and are located within the
PA. The RCAs contain elevated levels of radiation or contamination and
are generally located within the PA. The ERC is located offsite and is
where the licensee evaluates and coordinates licensee activities
related to an emergency, and communicates to Federal, State and local
authorities responding to radiological emergencies. The NRC requested
public comment on the issue in the Federal Register of May 11, 1994 (59
FR 24373). Comments were received from the nuclear industry, which
largely opposed a reduction in the scope of random testing, and from
elements of the IBEW, including Local 1245, which favored it. In SRM-
SECY-04-0229, dated January 10, 2005 (available on the NRC Web site at
http://www.nrc.gov/reading-rm/doc-collections/commission/srm/), the
Commission denied the IBEW exemption request because it--
(1) Would endanger the common defense and security (as a result of
increasing the likelihood of an insider threat); and
(2) Was not in the public interest (because reducing the scope of
random drug testing could increase the risk to public health and safety
due to a greater risk of both sabotage (insider threat due to
vulnerability to coercion) and of an accident (impaired worker)).
Consequently, this proposed rule would maintain the current
requirement for random drug and alcohol testing for personnel with
unescorted access to the PA at a nuclear power plant.
III. Abbreviations
The following abbreviations and acronyms are used in this Statement
of Considerations.
AEA Atomic Energy Act
ASDs Alcohol screening devices
BAC Blood alcohol concentration
CPL Conforming products list
C/V Contractor/vendor
DOT Department of Transportation
EAP Employee assistance program
EBT Evidential breath testing device
EPRI Electric Power Research Institute
FFD Fitness for duty
GC/MS Gas chromatography/mass spectrometry
HHS Department of Health and Human Services
IBEW International Brotherhood of Electrical Workers
KAs Knowledge and abilities
LOD Limit of detection
LOQ Limit of quantitation
mg/dL Milligrams per deciliter
MRO Medical Review Officer
NEI Nuclear Energy Institute
ng/dL Nanograms per deciliter
NHTSA National Highway Transportation Safety Administration
NRC Nuclear Regulatory Commission
NSF National Sleep Foundation
OMB Office of Management and Budget
PDFFDI Potentially disqualifying fitness-for-duty information
pH potential of hydrogen
POGO Project on Government Oversight
PROS Professional Reactor Operator Society
QA/QC Quality assurance/quality control
SAE Substance Abuse Expert
SAMHSA Substance Abuse and Mental Health Services Administration
[[Page 50446]]
SSNM Strategic special nuclear material
THC Tetrahydrocannabinol, delta-9-tetrahydrocannabinol-9-carboxylic
acid
UCS Union of Concerned Scientists
6-AM 6-acetylmorphine
IV. Discussion of Proposed Action
A. Overview
A review of FFD program experience confirms that the regulatory
approach of 10 CFR Part 26 is fundamentally sound and continues to
provide a means of deterrence and detection of substance abuse at
licensee facilities. NRC Information Notice 2003-04, ``Summary of
Fitness-for-Duty Program Performance Reports,'' dated February 6, 2003,
provides the latest published summary of program performance. This
document may be obtained from the NRC's Web site, http://www.nrc.gov,
by selecting the electronic reading room and then collections of
documents by type. It is also available in ADAMS under Accession No.
ML030350473.
Nonetheless, the NRC believes that revisions are needed to improve
the effectiveness and efficiency of FFD programs; enhance consistency
with advances in similar rules and guidelines, including the HHS
Guidelines and other Federal drug and alcohol testing programs that
place similar requirements on the private sector; strengthen the
effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue adversely affecting public health and safety and
the common defense and security by establishing clear and enforceable
requirements for the management of worker fatigue; enhance consistency
with the NRC's access authorization requirements; improve clarity in
the organization and language of the rule; and improve Part 26 by
eliminating or modifying unnecessary requirements.
B. Goals of the Rulemaking Activity
The Nuclear Regulatory Commission (NRC) proposes to amend 10 CFR
Part 26, Fitness for Duty Programs. The proposed goals are to:
(1) Update and enhance the consistency of 10 CFR Part 26 with
advances in other relevant Federal rules and guidelines, including the
U.S. Department of Health and Human Services Mandatory Guidelines for
Federal Workplace Drug Testing Programs and other Federal drug and
alcohol testing programs (e.g., those required by the U.S. Department
of Transportation [DOT]) that impose similar requirements on the
private sector.
(2) Strengthen the effectiveness of FFD programs at nuclear power
plants in ensuring against worker fatigue adversely affecting public
health and safety and the common defense and security by establishing
clear and enforceable requirements for the management of worker
fatigue;
(3) Improve the effectiveness and efficiency of FFD programs.
(4) Improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
(5) Improve Part 26 by eliminating or modifying unnecessary
requirements.
(6) Improve clarity in the organization and language of the rule.
(7) Protect the privacy and due process rights of individuals who
are subject to Part 26.
Each of these goals is expected to result in substantial
improvements in FFD programs. Many changes in the proposed rule relate
to each goal. The major changes for each subpart, and the reasons for
those changes, are described in Section IV. C and D of this document.
For each of the many specific changes that are being proposed, detailed
discussions are included in Section VI. However, the following
discussion provides a description of each goal, a basis for the need to
accomplish that goal, and several examples of proposed changes to the
rule that would contribute to meeting the goal.
Goal 1--Update and enhance the consistency of 10 CFR Part 26 with
advances in other relevant Federal rules and guidelines, including the
U.S. Department of Health and Human Services Mandatory Guidelines for
Federal Workplace Drug Testing Programs (referred to in this document
as the HHS Guidelines) and other Federal drug and alcohol testing
programs (e.g., those required by the U.S. Department of Transportation
[DOT]) that impose similar requirements on the private sector. Goal 1
is central to this rulemaking activity. Many changes are included in
the proposed rule to maintain consistency with advances in the conduct
of FFD programs, including changes in the HHS Guidelines. The 1994,
1998, and 2004 revisions to the HHS Guidelines differ substantially
from the 1988 version of the Guidelines, upon which the current rule is
based.
The President of the United States designated HHS as the agency
responsible for the Federal workplace drug testing program, and HHS'
Substance Abuse and Mental Health Services Administration (SAMHSA) is
responsible for maintaining the HHS drug testing guidelines based on
the most recent research and the accumulation of lessons learned from
the Federal drug testing program, as well as others who are regulated.
The NRC has historically relied on HHS to establish the technical
requirements for urine specimen collection, testing and evaluation, and
has only deviated from HHS' guidelines for considerations that are
specific to the nuclear industry. Updating Part 26 to be consistent
with HHS' most recent Guidelines ensures that NRC regulations continue
to be scientifically and technically sound.
Further, the HHS-certified laboratories that Part 26 requires
licensees to use for drug testing are required by HHS to follow the HHS
Guidelines in order to retain their certification. Basing Part 26 on
older versions of the HHS Guidelines, or deviating from those
Guidelines, increases the cost of drug testing for the nuclear
industry. Therefore, updating Part 26 to increase consistency with the
HHS Guidelines not only ensures that Part 26 is based on the best
scientific and technical information available, but also avoids
imposing an unnecessary and costly regulatory burden on the nuclear
industry.
One example of an improvement from enhancing consistency with the
HHS Guidelines is that several cutoff levels for detection of various
drugs would be updated, including a revised lower cutoff level for the
marijuana metabolite, THC. The lower cutoff level will provide greater
assurance that individuals who use marijuana are identified.
Additionally, a revision to the HHS Guidelines, published in the
Federal Register on April 13, 2004 (69 FR 19643) as a final rule,
includes requirements for instrumented specimen validity tests to
determine whether a urine specimen has been adulterated, diluted, or
substituted. This proposed rule would adopt significant portions of the
final HHS specimen validity testing provisions. The new validity
testing requirements will substantially improve the effectiveness of
the measures to guard against subversion of the testing process that
are contained in current Part 26.
Several other provisions for drug testing are under consideration
by HHS and were published as a proposed rule for public comment in the
Federal Register on April 13, 2004 (69 FR 19672). One proposed change
to 10 CFR Part 26 that was included from the proposed HHS Guidelines is
permission for licensees to use non-instrumented validity testing
devices to determine
[[Page 50447]]
whether a urine specimen must be subject to further testing at an HHS-
certified laboratory because it may have been adulterated, diluted, or
substituted, in lieu of the instrumented validity testing required in
the April 13, 2004, final version of the HHS Guidelines. Although the
HHS Guidelines that would permit Federal drug testing programs to use
non-instrumented validity testing devices for initial testing of urine
specimens are not yet final, some NRC licensees desired the flexibility
to use these testing methods. A technical basis for use of those
methods is included in Section VI. However, the NRC is not proposing to
include other provisions in the proposed HHS Guidelines at this time.
Those provisions include permitting the drug testing of specimens other
than urine (e.g., hair, saliva, sweat), requirements for split specimen
procedures for all specimens, and HHS certification of instrumented
initial test facilities, which would be analogous to licensee testing
facilities. Should such provisions be included in final HHS Guidelines
in the future, the NRC will consider incorporating them into 10 CFR
Part 26 at that time.
In addition to the proposed changes to 10 CFR Part 26 that
incorporate the recent revisions to the HHS Guidelines, the Department
of Transportation (DOT) revised its Procedures for Transportation
Workplace Drug and Alcohol Testing Programs [49 CFR 40, 65 FR 41944;
August 9, 2001] to include the use of oral fluids (i.e., saliva) as
acceptable specimens for initial alcohol screening tests. The proposed
rule would also reflect the new oral fluids testing technology to
provide FFD programs with increased flexibility in administering
initial alcohol tests.
Because the HHS Guidelines do not establish requirements for
alcohol testing, NRC relies on the DOT regulations, in part, to ensure
that the alcohol testing provisions of Part 26 remain scientifically
sound and legally defensible. Because the DOT programs test a much
larger number of individuals, in comparison to the number of alcohol
tests that are conducted under Part 26, basing the NRC's alcohol
testing regulations on portions of the DOT regulations reflects the
lessons learned from that larger population.
Goal 2--Strengthen the effectiveness of FFD programs at nuclear
power plants in ensuring against worker fatigue adversely affecting
public health and safety and the common defense and security by
establishing clear and enforceable requirements for the management of
worker fatigue. This goal is central to this rulemaking activity.
Proposed Subpart I, Managing Fatigue, would add clear and enforceable
requirements for licensee management of worker fatigue to 10 CFR Part
26. The proposed requirements would reduce the potential for worker
fatigue, and therefore strengthen the effectiveness of FFD programs at
nuclear power plants and substantially increase the protection of
public health and safety and the common defense and security. Section
VI discusses the specific reasons for each proposed worker fatigue
provision. Section IV. D provides a detailed discussion of the overall
basis for establishing fatigue management requirements for FFD
programs, and the benefits expected to result.
Goal 3--Improve the effectiveness and efficiency of FFD programs.
The NRC has gained experience in the actual implementation of FFD
programs since Part 26 was originally promulgated. The NRC is proposing
many changes throughout Part 26 based on that experience in order to
improve the industry's programs specifically to increase both the
effectiveness of the programs in achieving the goals of Part 26, and
the efficiency of program operations. Increasing the effectiveness and
efficiency of FFD programs will enhance the protection of public health
and safety and the common defense and security.
One example of a change related to Goal 3 is the proposed reduction
in the period within which pre-access testing must be performed from 60
days, in current Sec. 26.24(a)(1), to 30 days or less, in proposed
Subpart C [Granting and Maintaining Authorization]. This proposed
change would improve the effectiveness of the pre-access test in
detecting drug and alcohol use by individuals who are applying for
authorization to perform the types of job duties that require them to
be subject to Part 26 (see proposed Sec. 26.25 [Individuals subject to
the fitness-for-duty program]). Reducing the number of breath specimens
required for alcohol testing from two each for initial and confirmatory
testing, in current Section 2.4(g)(18) in Appendix A to Part 26, to one
specimen for the initial test and one for the confirmatory test, if
required, in proposed Sec. 26.91(d), would increase the efficiency of
FFD programs without compromising the accuracy and validity of alcohol
test results.
Another example would be establishing a regulatory framework for
the management of worker fatigue that appropriately balances the need
for flexibility to manage plant exigencies and worker individual
differences relative to fatigue with the need for more readily
enforceable requirements and efficient NRC oversight of licensee
compliance with the requirements and performance objectives of the
rule.
Goal 4--Improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
Current FFD and access authorization requirements each contain
provisions that relate to establishing the trustworthiness and
reliability of personnel prior to granting unescorted access to the
protected areas of nuclear power plants. The NRC has determined that,
because both sets of requirements share this same goal, revising Part
26 would clarify the relationship between these requirements,
particularly for licensee access authorization decisions regarding
personnel who move between sites with some interruption in their status
of having unescorted access to a nuclear power plant. In addition, some
requirements in Part 26 address the granting of temporary unescorted
access. In response to the terrorist attacks of September 11, 2001, on
the World Trade Center and the Pentagon, and the current threat
environment, the Commission took action to curtail the use of temporary
unescorted access at commercial nuclear power plants. Temporary
unescorted access was eliminated by orders issued January 7, 2003,
which imposed compensatory measures on existing access authorization
programs. Therefore, it is necessary to revise the related provisions
in Part 26.
Goal 5--Improve 10 CFR Part 26 by eliminating or modifying
unnecessary requirements. The proposed rule would incorporate a number
of changes to eliminate or modify unnecessary requirements. The
experience NRC has gained over the years since Part 26 was promulgated
have enhanced the agency's understanding of implementation by the
industry, and the NRC now proposes to eliminate or modify some
provisions, while at the same time maintaining the protection of public
health and safety and the common defense and security.
For example, because of inconsistencies in FFD and access
authorization requirements for conducting employment inquiries, many
licensees contacted an individual's previous employers twice--once to
obtain the information required under Part 26 and once to obtain the
information required for access authorization. Proposed revisions to
Part 26 would clarify that licensees may obtain information to satisfy
FFD
[[Page 50448]]
suitable inquiry requirements and related access authorization
requirements at the same time when conducting an employment inquiry.
Goal 6--Improve clarity in the organization and language of the
rule. The proposed rule is organized to facilitate implementation, as
compared to the current rule which has generated many questions from
licensees. Therefore, in the proposed rule, the NRC has substantially
reorganized the requirements to eliminate redundancies, to group
related requirements, and to present requirements in the order in which
they would apply to licensees' FFD processes. In addition, the NRC has
proposed many language changes to improve clarity. The NRC has
undertaken this substantial reorganization to improve the protection of
public health and safety and the common defense and security by
substantially reducing the likelihood of variations in FFD programs
across the industry through differing interpretations of the rule. The
proposed rule is clearer in both organization and language, and is
expected to result in more uniform implementation, and, consequently,
more consistency in achieving the Part 26 goals.
In contrast to certain NRC regulations, Part 26 includes a
considerable number of detailed requirements. In the public meetings
held during the development of this proposed rule, industry
representatives indicated that they consider this level of detail
necessary to help protect individual privacy and ensure consistency in
implementing the requirements. Additionally, industry representatives
indicated that this high level of detail can help to avoid unnecessary
litigation between licensees and individual personnel regarding worker
non-compliance with specific drug and alcohol testing performance
steps. Such litigation would be more likely if those specific
performance steps were not required by NRC rule. The level of detail
and the enhanced clarity in the new language and organization included
in proposed Part 26 have eliminated the need for a guidance document.
In the public meetings described in Section V, industry representatives
commented that a guidance document would not have the same weight as a
rule, and that both licensees and individuals should be protected fully
with rigor and specificity in a rule. Industry therefore desired the
rule to be more specific and detailed, in lieu of a guidance document.
Goal 7--Protect the privacy and due process rights of individuals
who are subject to 10 CFR Part 26. This goal is an implicit objective
of the current rule, and the proposed rule would also continue to
protect the privacy and due process rights of individuals who are
subject to 10 CFR Part 26. The NRC, DOT, and HHS have all gained
experience in implementing workplace drug and alcohol testing programs.
This experience has led DOT and HHS to modify many of their
requirements for such testing to more clearly protect privacy and due
process rights of individuals. Many of the proposed changes to Part 26
related to this goal are based on either DOT or HHS requirements. The
NRC believes the protection of individual rights to be of the highest
importance, and proposes changes to Part 26 to ensure that those rights
are protected through rule language developed using the best available
information. One example of such a change is that ``Bottle B'', the
second portion of a split urine specimen, would now only be tested with
the donor's written permission.
C. Overview of Proposed Rule
The proposed rule would be divided into subparts that contain
related requirements. This proposed change would be made to improve the
ease of implementing the rule by grouping related requirements and
presenting them generally in the order in which they would apply to
licensees' and other entities' FFD processes. Each subpart would be
assigned a descriptive title to aid users in locating rule provisions
and to simplify cross-referencing within the proposed rule. The major
topics addressed in each subpart and the reasons that the major changes
are being proposed are described below. A detailed cross-reference
table between the current and proposed Part 26 provisions is included
at the end of this notice.
Subpart A Administrative Provisions
The first subpart, proposed Subpart A [Administrative Provisions],
would replace the General Provisions portion of the current rule, but
continue to address the same subject matter. Thus, Subpart A would
address the purpose and scope of the rule, provide definitions of
important terms used in the proposed rule, and update current
provisions related to requests for specific exemptions, interpretations
of the rule, and communications with the NRC.
Subpart B Program Elements
Subpart B [Program Elements] of the proposed rule would reorganize
and amend current Sec. Sec. 26.10-26.29, which specify the performance
objectives that FFD programs would be required to meet and the FFD
program elements that licensees and other entities must implement to
meet the performance objectives. However, the proposed rule would not
include current Sec. 26.27 [Management actions and sanctions to be
imposed] in Subpart B for two reasons. First, at the public meetings
described in Section V. B, stakeholders requested that the rule be
reorganized to be consistent with the order in which licensees and
other entities would implement their programs. Because Subpart B would
be focused on establishing the framework of FFD programs, it would be
premature to present requirements related to implementing the FFD
program (i.e., imposing sanctions on an individual for violating the
FFD policy) at this point in the proposed rule. Second, the
stakeholders suggested, and the NRC staff concurred after
consideration, that the subject matter of current Sec. 26.27 is
sufficiently important and complex that a separate subpart is
warranted. Therefore, the proposed rule would present requirements
related to management actions and sanctions in proposed Subpart D
[Management Actions and Sanctions to be Imposed].
Subpart C Granting and Maintaining Authorization
Subpart C [Granting and Maintaining Authorization] of the proposed
rule would substantially amend current FFD requirements related to the
process that licensees and other entities must follow in determining
whether an individual is trustworthy and reliable, as demonstrated by
avoiding substance abuse, and can be expected to perform his or her job
duties safely and competently. The proposed rule would introduce the
concept of ``authorization'' to Part 26 to refer to the status of an
individual who the licensee or other entity has determined can be
trusted to perform the job duties described in proposed Sec. 26.25
[Individuals subject to the fitness-for-duty program], as a result of
the process described in this subpart. For example, in the case of
nuclear power plant personnel, an individual who is ``authorized''
under Part 26 may be permitted to have unescorted access to protected
areas in nuclear power plants if the individual's job requires such
access.
The NRC has published other requirements, such as 10 CFR 73.56,
that establish additional steps that licensees and other entities must
take as part of the process of determining whether to grant
authorization to an individual or permit an individual to
[[Page 50449]]
maintain authorization. These additional requirements focus on aspects
of an individual's character and reputation other than substance abuse,
and, among other steps, require the licensee or other entities who are
subject to the rule to conduct a psychological assessment of the
individual, a credit and criminal history check, and interview
individuals who have knowledge of the applicant for authorization.
However, as discussed in Section IV. B, historically there have been
some inconsistencies and redundancies between the Part 26 requirements
related to granting and maintaining authorization and the other,
related regulations, particularly the NRC's access authorization
requirements for nuclear power plant personnel. The inconsistencies
have led to many implementation questions from licensees, as well as
inconsistencies in how licensees have implemented the requirements. The
redundancies have, in other cases, imposed an unnecessary burden on
licensees. Therefore, a central goal of adding Subpart C to the
proposed rule is to eliminate those inconsistencies and redundancies to
ensure that licensees and the other entities who are subject to the
rule have clear and easily interpretable requirements to follow when
determining whether to grant or maintain an individual's authorization
under Part 26 and also under other, related requirements, including,
but not limited to, the access authorization orders issued by the NRC
to nuclear power plant licensees on January 7, 2003.
The requirements in proposed Subpart C are based upon several
fundamental changes to the NRC's approach to the authorization
requirements in current Part 26. The primary concern, which Subpart C
is designed to address, is the necessity of increasing the rigor of the
authorization process to provide reasonable assurance that any
individual who is granted and maintains authorization is trustworthy
and reliable, as demonstrated by avoiding substance abuse. The
necessity for increased rigor in the authorization process is discussed
in Section IV. C with respect to proposed Sec. 26.23(a) in terms of
the increased insider threat since the terrorist attacks of September
11, 2001. One change to current Part 26 authorization requirements that
reflects this concern is the elimination of temporary access
authorization requirements in the second sentence of current Sec.
26.27(a)(4). Other changes are discussed in Section IV with respect to
the specific provisions that would incorporate them.
A second, related change to the NRC's approach to authorization
requirements, which has informed proposed Subpart C, is an increased
concern with the sharing of information about individuals between
licensees and other entities. At the time the current Part 26 was
developed, the industry structure was different and personnel transfers
between licensees (i.e., leaving the employment of one licensee to work
for another licensee) with interruptions in authorization were less
common. Most licensees operated plants at a single site and maintained
an FFD program that applied only to that site. When an individual left
employment at one site and began working for another licensee, the
individual was subject to a different FFD program that often had
different requirements. Because some licensees were reluctant to share
information about previous employees with the new employer, licensees
often did not have access to the information the previous licensee had
gathered about the individual and so were required to gather the
necessary information again. The additional effort to collect
information that another licensee held created an unnecessary burden on
both licensees. But, because few individuals transferred, the burden
was not excessive.
However, since 1989, the industry has undergone significant
consolidation and developed new business practices to use its workforce
more efficiently. Industry efforts to better use expertise and staffing
resources have resulted in the development of a large transient
workforce within the nuclear industry that travels from site to site as
needed, such as roving outage crews. Although the industry has always
relied upon C/Vs for special expertise and staff for outages, the
number of transient personnel who work solely in the nuclear industry
has increased and the length of time they are on site has decreased.
Because the current FFD regulations were written on the basis that
individual licensees would maintain independent, site-specific FFD
programs and would share limited information, and that the majority of
nuclear personnel would remain at one site for years, the regulations
do not adequately address the transfer of personnel between sites.
These changes in the industry have increased the need for
information sharing among licensees and C/Vs. The increased insider
threat since September 11, 2001, has also heightened the need for
information sharing among licensees and C/Vs to ensure that licensees
and other entities have information that is as complete as possible
about an individual when making an authorization decision. To address
this need, the access authorization orders issued by the NRC to nuclear
power plant licensees on January 7, 2003, mandated increased sharing of
information. In addition, proposed Subpart C would require licensees
and other entities to collect and share greater amounts of information
than under the current rule, subject to the protections of individuals'
privacy that would be specified in proposed Sec. 26.37 [Protection of
information]. As a result, individuals who are subject to the rule
would establish a detailed ``track record'' within the industry that
would follow them if they change jobs and move to a new position that
requires them to be granted authorization by another licensee or entity
who is subject to the rule. This increased information sharing would
contribute to providing reasonable assurance that individuals who are
granted and maintain authorization are trustworthy and reliable when
individuals move between FFD programs.
However, a consequence of increased information sharing is that one
violation of any licensee's FFD policy has greater potential to end an
individual's career. Although an individual who has an active substance
abuse problem cannot be permitted to hold authorization, the NRC
continues to affirm that individuals who pursue treatment, stop abusing
drugs or alcohol, and maintain sobriety for an extended period of time
should regain the public's trust. The length of time that an individual
must maintain sobriety in order to demonstrate that he or she can again
be trusted with the public's health and safety and the common defense
and security has been a matter of debate since Part 26 was originally
under development. However, the research literature continues to
indicate that individuals who maintain sobriety past the first 3 years
following treatment have substantially reduced recidivism rates (i.e.,
relapsing into substance abuse) than during the first 3 years after
treatment and there is a further drop in recidivism rates after 5 years
of sobriety.
Despite these research findings, some individuals who have had one
confirmed positive test result have been prevented from working in
operating nuclear power plants. The increased information sharing that
would be required under Subpart C has the potential to result in a
greater number of such individuals being banned from working in the
industry. Therefore, several requirements would be added to
[[Page 50450]]
proposed Subpart C to minimize such consequences for individuals who
are able to demonstrate that they have resolved a substance abuse
problem. Additional requirements for protecting information that would
be gathered about individuals under proposed Part 26 would be specified
in proposed Sec. 26.37 [Protection of information]. The detailed
changes to current requirements are discussed in Section VI with
respect to the specific provisions that would incorporate them.
In general, the authorization requirements in proposed Subpart C
would be structured according to whether an individual who has applied
for authorization has previously held authorization under Part 26. If
an individual has not established a ``track record'' in the industry,
the proposed rule would require licensees and other entities to meet an
extensive set of requirements before granting authorization to the
individual. If an individual has established a favorable track record
in the industry, the amount of original information gathering that the
proposed rule would require licensees and other entities to complete
before granting authorization to the individual would be reduced. The
need for original information gathering in these instances would be
reduced because, under the proposed rule, licensees and other entities
would have access to all of the information that previous FFD programs
had collected about the individual.
For individuals who have established a favorable track record in
the industry, the steps that licensees and other entities would be
required to complete in order to grant authorization to an individual
would also depend upon the length of time that has elapsed since the
individual's last period of authorization was terminated and the amount
of supervision to which the individual was subject during the
interruption. (The term, ``interruption,'' refers to the interval of
time between periods during which an individual holds authorization
under Part 26.) In general, the more time that has elapsed since an
individual's last period of authorization ended, the more steps that
the proposed rule would require licensees and other entities to
complete before granting authorization to the individual. However, if
the individual was subject to behavioral observation under a Part 26
program or continued to be subject to random drug and alcohol testing
during the interruption, the proposed rule would require licensees and
other entities to complete fewer steps in order to grant authorization
to the individual. There are several reasons that the proposed rule
would require fewer steps in the authorization process for these
individuals.
First, individuals who have established a favorable work history in
the industry have demonstrated their trustworthiness and reliability
from previous periods of authorization, so they pose less potential
risk to public health and safety and the common defense and security
than individuals who are new to the industry. Much is known about these
individuals. Not only were they subject to the initial background
screening requirements before they were initially granted
authorization, but, while they were working under a Part 26 program,
they were watched carefully through on-going behavioral observation,
repeatedly attained negative results from random drug and alcohol
tests, and demonstrated the ability to consistently comply with the
many procedural requirements that are necessary to perform work safely
at operating power reactor facilities.
Second, individuals who have established a favorable work history
in the industry and whose authorization has been interrupted for only a
short period would be unlikely to develop an active substance abuse
problem during the interruption. The shorter the period of time since
the individual's last period of authorization ended, the less likely it
is that the individual would have developed an active substance abuse
problem or undergone significant changes in lifestyle or character that
would diminish his or her trustworthiness, reliability, and ability to
perform work safely and competently.
Further, if the individual was also subject to supervision under
some elements of a Part 26 program (e.g., behavioral observation, a
requirement to report any arrests, random drug and alcohol testing)
during the period that his or her authorization was interrupted, the
higher the assurance that the individual does not have an active
substance problem. And, the less likely it would be that the individual
could have undergone significant changes in lifestyle or character that
would be undetected.
Therefore, the proposed rule would establish categories of
requirements for granting authorization to an individual that would
vary, based upon whether the individual has previously held
authorization under Part 26; whether the individual's last period of
authorization was terminated favorably or unfavorably; how long it has
been since the individual last held authorization under Part 26; and
whether the individual was subject to any elements of a Part 26 program
during the interruption period. Proposed Sec. 26.55 [Initial
authorization] would establish authorization requirements for
individuals who have not previously held authorization under Part 26
and individuals who have not held authorization within the past 3
years. Proposed Sec. 26.57 [Authorization update] would establish
authorization requirements for individuals who previously held
authorization under Part 26, whose last period of authorization was
terminated favorably more than 1 year ago but less than 3 years ago.
Proposed Sec. 26.59 [Authorization reinstatement] would establish
authorization requirements for individuals who previously held
authorization under Part 26 and whose last period of authorization was
terminated favorably within the past year. Proposed Sec. 26.69
[Authorization with potentially disqualifying fitness-for-duty
information] would define the steps that licensees and other entities
must take in granting authorization to an individual about whom
potentially disqualifying FFD information has been disclosed or
discovered.
The time periods used to establish these categories of
authorization requirements would be consistent with the categories
established in the access authorization orders issued by the NRC to
nuclear power plant licensees on January 7, 2003. Basing the proposed
requirements on elapsed time is consistent with the programs of other
Federal agencies who have similar needs to control access to sensitive
information and protected areas. In addition, these time periods have
been used successfully within nuclear power plant access authorization
programs since 1989 and have met the NRC's goal of ensuring that
individuals who are granted unescorted access are trustworthy and
reliable. Therefore, the proposed rule would incorporate these time
periods within Part 26.
In general, the steps that would be required to grant authorization
to an individual who has recently held authorization and whose most
recent period of authorization was terminated favorably would be less
extensive than the steps required for applicants for authorization who
are new to the industry or those who have not recently held
authorization. In addition, the requirements for a rigorous evaluation
process contained in the current Sec. 26.27(e) would be strengthened
and licensees and other entities would be required to meet them before
granting authorization to an individual about whom potentially
disqualifying FFD information has been disclosed or
[[Page 50451]]
discovered (see proposed Sec. 26.69). The proposed rule would require
licensees and other entities to obtain and review a written self-
disclosure from the applicant and an employment history, and ensure
that a suitable inquiry and pre-access drug and alcohol testing are
completed before granting authorization to an individual, with certain
exceptions. The proposed exceptions to the self-disclosure and
employment history, suitable inquiry, and pre-access testing
requirements would be specified in proposed Sec. Sec. 26.61 [Self-
disclosure and employment history], 26.63 [Suitable inquiry], and 26.65
[Pre-access drug and alcohol testing], respectively. The proposed rule
would also require licensees and other entities to ensure that
applicants are subject to random testing, as specified in proposed
Sec. 26.67 [Random drug and alcohol testing of individuals who have
applied for authorization].
Subpart D Management Actions and Sanctions
Subpart D [Management Actions and Sanctions] of the proposed rule
would replace current Sec. 26.27(b) and (c) and divide the current
provisions into two separate sections that specify requirements for
responding to FFD policy violations in proposed Sec. 26.75
[Sanctions], and indications of impairment in proposed Sec. 26.77
[Management actions regarding possible impairment]. The current rule
would be reorganized in response to stakeholder requests that were made
during the public meetings discussed in Section V. The stakeholders
requested that the proposed rule generally reflect the order in which
the requirements apply to licensees' and other entities' FFD processes
and that related requirements be grouped into separate sections.
Therefore, this change would be made to meet Goal 6 of this rulemaking,
which is to improve clarity in the organization and language of the
rule.
In general, proposed Subpart D would include three significant
changes from the related provisions in the current rule that are each
intended to provide a stronger deterrent to engaging in the unwanted
actions specified in the proposed subpart. First, the proposed rule
would increase the severity of the minimum sanctions that are required
if an individual violates a licensee's or other entity's FFD policy.
The more stringent sanctions would be necessary in order to strengthen
the effectiveness of the rule in providing reasonable assurance that
individuals who are subject to this part are trustworthy and reliable,
as demonstrated by avoiding substance abuse, and by increasing the
assurance that only individuals who are fit for duty are permitted to
perform the job duties listed in proposed Sec. 26.25 [Individuals
subject to the fitness-for-duty program].
Second, the proposed rule would require licensees and other
entities who are subject to the rule to impose the same sanctions for
an FFD violation involving the abuse of alcohol as required for the
abuse of illegal drugs. Impairment caused by alcohol abuse creates a
risk to public health and safety that is fundamentally similar to the
risk posed by the use of illegal drugs. Some licensees, however, have
imposed lesser sanctions for alcohol violations, an approach that is
inconsistent with the NRC's intent. Therefore, the proposed rule would
rectify this situation by explicitly requiring the same minimum
sanctions for abuse of alcohol as currently required for the use of
illegal drugs.
Third, the proposed rule would add the sanction of permanent denial
of authorization for any individuals who subvert or attempt to subvert
the testing process. The current rule permits licensees and other
entities to have flexibility in establishing sanctions for actions such
as refusing to submit to testing and attempting to subvert the testing
process by submitting an adulterated or substitute specimen. As a
result, different FFD programs have imposed different sanctions and
some individuals have been granted authorization or permitted to
maintain authorization when they have committed such acts. However,
acts to defeat the testing process indicate that an individual is not
trustworthy and reliable and suggest that the individual may be
engaging in substance abuse that could pose a risk to public health and
safety and the common defense and security. Therefore, the proposed
rule would establish a minimum sanction that all FFD programs must
impose to deter attempts to subvert the testing process as well as
provide reasonable assurance that individuals who are granted and
maintain authorization can be trusted to comply with the rules and
regulations to which they are subject.
These three changes would be made to meet Goal 3 of this
rulemaking, which is to improve the effectiveness of FFD programs, as
discussed in Section IV. B. Other changes to current Sec. 26.27(b) and
(c) in proposed Subpart D would be made primarily to eliminate or
modify unnecessary requirements and clarify the intent of current
provisions.
Subpart E Collecting Specimens for Testing
Subpart E [Collecting specimens for testing] of the proposed rule
would reorganize and amend the requirements related to collecting
specimens for drug and alcohol testing that are contained in current
Sec. 26.24 [Chemical and alcohol testing] and interspersed throughout
current Appendix A to Part 26. The proposed subpart would group the
related requirements and present them in the order in which they would
be implemented by FFD programs. The proposed rule would also eliminate
some redundancies in the provisions of the current rule that are
related to specimen collections, as is discussed in Section VI, with
respect to the specific provisions. These proposed changes would be
made to meet Goal 6 of the rulemaking, which is to improve clarity in
the organization and language of the rule, as discussed in Section IV.
B.
In general, the procedures in this subpart would be more detailed
than those in Appendix A to the current rule, and also those NRC
regulations that are based upon a risk-informed, performance-based
approach, for several reasons. First, the more detailed procedures in
proposed Subpart E would increase the consistency of Part 26 drug and
alcohol specimen collection procedures with those of other Federal
agencies and therefore would take advantage of the scientific and
technical advances that have been made in workplace drug and alcohol
testing programs since the current Part 26 was promulgated, as
discussed in Section IV. B. Second, the proposed rule would permit Part
26 FFD programs to accept and rely upon other Part 26 programs, as well
as the programs of other Federal and State agencies, to a much greater
extent than is permitted under the current rule. The proposed
permission to rely on other programs would improve the effectiveness
and efficiency of FFD programs (Goal 3 of the rulemaking) and improve
10 CFR Part 26 by eliminating or modifying unnecessary requirements
(Goal 5 of the rulemaking). For example, under proposed Sec.
26.69(b)(6), the proposed rule would permit licensees and other
entities to rely upon another Part 26 program's drug and alcohol
followup testing of an individual who has violated an FFD policy and is
consequently required to have at least 15 followup tests within the
three-year period following the violation, and is transferring from one
licensee's site to another. The proposed rule would require the
receiving licensee or other entity to continue the followup testing
[[Page 50452]]
program. However, the proposed rule would permit the licensee or other
entity to accept the followup testing that was completed by the
previous FFD program when determining the remaining number of followup
tests to which the individual must be subject and the period of time
during which the individual must continue to be subject to followup
testing. Therefore, because the proposed rule would permit such
reliance on other programs, more detailed requirements for conducting
the activities upon which other FFD programs may rely, including drug
and alcohol testing, are necessary to provide greater assurance that
all Part 26 programs meet minimum standards. Third, at the public
meetings discussed in Section V, industry stakeholders requested a
greater level of detail in the specimen collection procedures of the
proposed rule for the reasons discussed in Section IV. B.
Other major changes to the current rule's requirements for
collecting specimens for drug and alcohol testing would be made to
incorporate specimen validity testing requirements from the HHS
Guidelines into Part 26 (Goal 1 of this rulemaking) and modify current
alcohol testing requirements to improve the efficiency of FFD programs
(Goal 3 of the rulemaking), while continuing to protect or enhance
individuals' rights to privacy and due process under the rule (Goal 7
of the rulemaking).
Subpart F Licensee Testing Facilities
Subpart F [Licensee Testing Facilities] of the proposed rule would
present detailed requirements for conducting initial urine specimen
validity and drug tests at licensee testing facilities, as permitted in
Sec. 26.24(d)(1) of the current rule and Sec. 26.31(d)(3)(i) of the
proposed rule. The proposed subpart would be entitled, ``Licensee
Testing Facilities,'' for brevity, but other entities who are subject
to the proposed rule would be permitted to establish and operate such
facilities under the proposed rule.
This new subpart would be added to group together in a single
subpart the proposed requirements that are related to licensee testing
facilities, which are intermixed with requirements related to drug
testing at HHS-certified laboratories in Appendix A to Part 26 in the
current rule. During the public meetings discussed in Section V,
stakeholders requested that the proposed rule present the requirements
that would be applicable to licensee testing facilities and HHS-
certified laboratories in two separate subparts because, the
stakeholders noted, it is not always clear which requirements apply to
which type of testing facility in the current rule. The stakeholders
also requested that any requirements that apply to both types of
facilities would be included in both subparts so that it would be
unnecessary for licensees and other entities who do not operate
licensee testing facilities to review or implement any provisions in
Subpart F. Although many of the requirements in this subpart would be
redundant with similar requirements in proposed Subpart G [Laboratories
Certified by the Department of Health and Human Services], the proposed
rule would implement these recommendations to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
The most important changes in proposed Subpart F to the current
requirements for licensee testing facilities would be the addition of
new requirements for licensee testing facilities to conduct urine
specimen validity testing, based on similar provisions contained in the
most recent revision to the HHS Guidelines (69 FR 19643; April 13,
2004). The reasons for requiring urine specimen validity testing are
discussed in Section VI with respect to proposed Sec. 26.31(d)(3)(I).
As discussed in Section V, stakeholders have objected to the addition
of requirements for licensee testing facilities to conduct validity
testing. However, the NRC believes that it is necessary for licensee
testing facilities to conduct specimen validity testing because Part 26
permits licensees and other entities to make authorization decisions
based on initial drug test results from such facilities. Thus,
licensees and other entities are permitted to grant authorization to an
individual who has negative initial test results from pre-access
testing without further analysis of the urine specimen by an HHS-
certified laboratory. If the initial test results from the licensee
testing facility are inaccurate because the urine specimen was
adulterated or substituted, the licensee or other entity could grant
authorization to an individual who poses a risk to public health and
safety and the common defense and security. Similarly, if an individual
who has been selected for random testing submits an adulterated or
substituted specimen that is not detected by initial tests at the
licensee testing facility, the individual would be permitted to
maintain authorization if the results of drug testing are negative.
Therefore, in order to increase the likelihood that individuals who may
be using drugs and attempting to defeat the testing process are
detected, and to ensure that they would not be permitted to be granted
or maintain authorization, the NRC has concluded that it is necessary
to require licensee testing facilities to conduct urine specimen
validity tests.
However, in consideration of the increased costs and burden that
are associated with instrumented initial validity testing, proposed
Subpart F would permit licensee testing facilities to use non-
instrumented validity testing devices to conduct ``validity screening
tests'' of urine specimens, which may be a less expensive alternative
than the instrumented initial validity tests required in the current
HHS Guidelines. As discussed in Section VI with respect to proposed
Sec. 26.5 [Definitions], the proposed rule would use the term,
``validity screening test,'' to refer to testing using these non-
instrumented devices. The term, ``initial validity test,'' would refer
to instrumented validity testing.
At the same time that the HHS published its final regulations to
require specimen validity testing, which would be incorporated in the
proposed rule, HHS also published a proposed revision to the Guidelines
(69 FR 19673; April 13, 2004) that would permit the use of validity
screening devices for the detection of substitution and the presence of
adulterants in urine specimens. These devices include non-instrumented
devices with visually-read endpoints as well as semi-automated or
automated instrumented testing devices with machine-read end points.
Specimen validity tests conducted with these devices use colorimetric
assays, which is the same scientific principle as the initial tests
conducted at HHS-certified laboratories. Non-instrumented specimen
validity devices for urine testing have been shown to detect
adulterants in urine specimens and creatinine concentrations on tests
that were conducted on specimens that were spiked with drug analytes.
However, the results from the preliminary studies are variable.
Therefore, the proposed HHS Guidelines include extensive performance
testing requirements for these devices, which proposed Subpart F would
also incorporate. Such performance testing is necessary to ensure that
validity test results based on using these devices are accurate.
Subpart G Laboratories Certified by the Department of Health and Human
Services
Subpart G [Laboratories Certified by the Department of Health and
Human Services] in the proposed rule would present together in a single
subpart requirements related to the HHS-certified laboratories that are
used by
[[Page 50453]]
licensees and other entities who are subject to Part 26 for validity
and drug testing. The requirements in this subpart would group together
the current requirements in Appendix A to Part 26, as they relate to
HHS-certified laboratories. However, the current requirements would be
updated to be consistent with the HHS Guidelines that were published in
the Federal Register on April 13, 2004 (69 FR 19643). The most
important changes to the current rule's requirements for HHS-certified
laboratories would be the incorporation of extensive requirements for
urine specimen validity testing.
Subpart H Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Subpart H [Determining Fitness-for-Duty Policy Violations and
Determining Fitness] in the proposed rule would reorganize, clarify,
and enhance current requirements related to the decisions that MROs and
other healthcare professionals must make under Part 26 to provide input
to licensees' and other entities' management decisions with respect to
granting and permitting an individual to maintain authorization under
proposed Subpart C [Granting and Maintaining Authorization] and also
with respect to imposing sanctions and taking actions to prevent an
individual from performing the job duties that require an individual to
be subject to this part under proposed Subpart D [Management Actions
and Sanctions]. The current requirements, which are interspersed
throughout the rule, would be grouped together in the proposed subpart
to make them easier to locate within the proposed rule, consistent with
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule, as discussed in Section IV. B.
The proposed subpart would also make several significant changes to
current requirements.
In general, proposed Subpart H would include more detailed
requirements for determining FFD policy violations and conducting
determinations of fitness than are included in the current rule. These
more detailed requirements would be added in response to implementation
questions that the NRC has received from licensees since Part 26 was
first promulgated, ``lessons learned'' from NRC inspections of FFD
programs, and the experience of other Federal agencies that similarly
require workplace drug and alcohol testing. However, the NRC's primary
concern in establishing more detailed requirements is to enhance the
consistency in how FFD policy violations and fitness are determined
among Part 26 programs. The proposed rule would permit licensees and
other entities to rely on the determinations made by other Part 26
programs to a greater extent than the current rule. For example,
proposed Sec. 26.63(b) would permit licensees and other entities to
rely upon a previous licensee's or other entity's determinations of
fitness, as well as their reviews and resolutions of potentially
disqualifying FFD information, for previous periods of authorization.
The reasons for adding these permissions were discussed previously in
this section, with respect to proposed Subpart C [Granting and
Maintaining Authorization]. However, in order to ensure that all
licensees' and other entities' determinations of FFD policy violations
and fitness can be relied upon by other FFD programs, it is necessary
to enhance the current requirements and establish clear minimum
standards for those processes. Therefore, the proposed subpart would
include greater detail to meet Goal 3 of this rulemaking, which is to
improve the effectiveness and efficiency of FFD programs.
Under the proposed rule, licensees and other entities who are
subject to the rule would continue to be prohibited from imposing
sanctions on an individual who has a positive confirmatory drug test
result from testing at the HHS-certified laboratory until the MRO has
had an opportunity to discuss the result with the individual and
determines that there is no legitimate medical explanation for the
positive result(s). The proposed rule would extend this requirement to
the review of non-negative validity test results, consistent with the
addition of requirements to conduct validity testing throughout the
proposed rule, as discussed in Section VI with respect to proposed
Sec. 26.31(d)(3)(i). An MRO review of non-negative confirmatory
validity test results before a licensee or other entity imposes
sanctions on an individual is necessary for the same reasons that an
MRO review is required of positive drug test results. That is, there
may be legitimate medical reasons for the non-negative test result and
the test result may not indicate that the donor has violated the FFD
policy, which in this case would mean that he or she has not attempted
to subvert the testing process. Requiring the MRO to review non-
negative validity test results would be added to meet Goal 7 of this
rulemaking, which is to protect the due process rights of individuals
who are subject to Part 26. The HHS Guidelines also require the MRO to
review non-negative validity test results. Therefore, adding this
requirement to the proposed rule would also meet Goal 1 of this
rulemaking, which is to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines.
Another significant change that the proposed rule would make to
current requirements is establishing a new position within FFD
programs--the ``substance abuse expert'' (SAE). The SAE would be
responsible for performing a determination of fitness, which is
determining whether there are indications that an individual may be in
violation of the licensee's or other entity's FFD policy or is
otherwise unable to safely and competently perform his or her duties,
in those instances in which an individual may not be fit for duty for
reasons related to drug or alcohol abuse. The SAE position would be
added for several reasons.
First, some MROs who provide services under Part 26 have indicated
that they do not feel qualified to assess the presence and severity of
substance abuse disorders, make treatment recommendations, and
determine when an individual who has had a substance abuse disorder may
again be able to safely and competently perform duties under this part.
The focus of MRO responsibilities under Part 26 and other Federal
workplace drug testing programs is on the medical evaluation of non-
negative test results, which requires a knowledge of substance abuse.
However, some MROs do not have the extensive knowledge of substance
abuse disorders that is necessary to make determinations of fitness and
treatment recommendations as required under this part. Therefore, the
proposed rule would permit MROs to serve as SAEs if they meet the
qualifications for this role that would be established in this subpart.
But, licensees and other entities would be required to rely on other
healthcare professionals who have the necessary qualifications to
conduct determinations of fitness if the MRO does not meet the proposed
SAE qualification requirements.
Second, during the meetings discussed in Section V, stakeholders
requested that healthcare professionals, other than a licensed
physician, be permitted to make determinations of fitness under the
proposed rule. The stakeholders indicated that the costs of using only
licensed physicians are prohibitive and noted that a license to
practice medicine does not guarantee that a physician is knowledgeable
about substance abuse disorders. The NRC concurs that healthcare
professionals
[[Page 50454]]
other than licensed physicians may have the requisite knowledge and
skills to serve as SAEs under the proposed rule. Therefore, the
proposed rule would define the position of SAE in terms of the
knowledge and skills required, and permit healthcare professionals
other than licensed physicians to serve in this role.
Third, under the proposed rule, FFD programs would be permitted to
accept determinations of fitness and treatment plans from other Part 26
programs, if an individual who has had a substance abuse problem will
be granted authorization by another licensee or entity. Consequently,
detailed requirements for the qualifications and responsibilities of
the SAE are necessary to ensure consistency among FFD programs.
Detailed requirements for the qualifications and responsibilities of
the SAE are necessary because of the key role the SAE would play in
assuring the common defense and security and public health and safety
when making a determination of fitness upon which licensees and other
entities will rely when making authorization decisions. It is critical
that SAEs understand the potential impact on the common defense and
security and public health and safety when determining that an
individual who has had an active substance abuse problem has resolved
the problem and is again worthy of the public's trust. A sophisticated
understanding of substance abuse problems and the types of adverse
behaviors they may involve, including knowledge of the research
literature and clinical experience, is necessary to inform the SAE's
clinical judgements in these circumstances.
Many of the provisions in the proposed subpart would be adapted
from related DOT requirements regarding the ``substance abuse
professional'' [49 CFR Part 40, Subpart O; 65 FR 41944; August 9,
2001]. The SAE role is not defined in current Part 26.
Subpart I Managing Fatigue
Subpart I [Managing Fatigue] of the proposed rule would strengthen
the effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue adversely affecting public health and safety and
the common defense and security by establishing clear and enforceable
requirements for the management of worker fatigue. Because the overall
rationale for including Subpart I, Managing Fatigue, in Part 26, is
detailed and extensive, this discussion is presented separately in
Section IV. D.
Subpart J Recordkeeping and Reporting Requirements
Subpart J [Recordkeeping and Reporting Requirements] would be added
to the proposed rule to reorganize the current rule's requirements for
maintaining records and submitting reports to the NRC. The new subpart
would combine and amend two sections of the current rule: Section 26.71
[Recordkeeping requirements] and Sec. 26.73 [Reporting requirements],
and would incorporate the record retention requirements of current
Sec. Sec. 26.21(b), 26.22(c), and 26.80(c). This proposed change would
be made to meet Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule, by grouping related
requirements together in the proposed subpart.
Major changes to the current rule's requirements for recordkeeping
and reporting would reflect (1) the addition of requirements for
specimen validity to the proposed rule; (2) the addition of
requirements for managing worker fatigue at nuclear power plants; and
(3) a relaxation of the required frequency with which Part 26 programs
must submit FFD program performance reports to the NRC from bi-annually
to annually.
Subpart K Inspections, Violations, and Penalties
Subpart K [Inspections, Violations, and Penalties] would be added
to the proposed rule to combine into one subpart current Sec. Sec.
26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal penalties].
These sections would be grouped together in one subpart because they
each establish requirements related to the NRC's oversight of the
implementation of FFD programs. Proposed Sec. 26.221 [Inspections]
would retain the requirements in current Sec. 26.70. Proposed Sec.
26.223 [Violations] would retain the requirements in current Sec.
26.90 [Violations]. Proposed Sec. 26.225 [Criminal penalties] would
retain the requirements in current Sec. 26.91 [Criminal penalties].
D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26
The NRC has determined that the effectiveness of FFD programs in
ensuring against worker fatigue adversely affecting public health and
safety and the common defense and security should be strengthened by
establishing clear and enforceable requirements for the management of
worker fatigue. Subpart I, Managing Fatigue, of the proposed rule would
include these requirements and establish an integrated approach to
fatigue management, with fatigue prevention, detection, and mitigation
as the fundamental components. As discussed further in this section,
the proposed requirements in Subpart I would provide a substantial
increase in the protection of public health and safety and common
defense and security. In determining the provisions of this proposed
rule, the NRC has taken into consideration the effects of fatigue; the
specific work practices of the nuclear power industry that contribute
to and mitigate fatigue; the inadequacy of the current regulatory
framework; the excessive hours currently worked by many nuclear power
workers; and the practices of other industries and countries for
regulating work hour limits. In addition, many public meetings were
held with the nuclear industry and the public to discuss draft
provisions for the proposed rule. These interactions are discussed in
detail in Section V of this document.
The NRC has determined that an integrated approach is necessary to
effectively manage worker fatigue because individuals experience
fatigue for many reasons, including long work hours, inadequate rest,
and stressful or strenuous working conditions. Shiftwork, home-life
demands, and sleep disorders can all contribute to inadequate sleep and
excessive fatigue. Individual differences in worker tolerances to these
conditions also influence worker fitness for duty. As a consequence,
fatigue is a complex phenomenon that requires an integrated approach to
be managed effectively. The requirements in proposed Subpart I were
developed based upon the premise that fatigue management requires the
collaboration of individual workers and licensees.
Each of the proposed requirements in Subpart I are discussed in
detail in Section VI. However, because proposed Subpart I presents an
integrated fatigue management approach, this section discusses the
principal findings that led to the decision to include fatigue
management provisions in Part 26, as well as supporting information on
the causes and problems with worker fatigue in the nuclear power
industry.
The Commission approved a rulemaking plan to include worker fatigue
provisions for nuclear power plants in 10 CFR Part 26 on January 10,
2002, (SRM-SECY-01-0113), as described in Section I. Since that time,
the NRC has continued to analyze the need for work-hour provisions in
the proposed rule. The considerations listed in the numbered paragraphs
that follow summarize the NRC's considerations
[[Page 50455]]
concerning the appropriate regulatory action to address the potential
for worker fatigue to affect public health and safety and the common
defense and security. These considerations include:
(1) The research literature demonstrating the substantive effects
of fatigue and decreased alertness on an individual's ability to safely
and competently perform his or her duties;
(2) The prevalence of conditions that contribute to worker fatigue
in the U.S. nuclear power industry;
(3) With the exception of orders limiting the work hours of
security personnel, the NRC's current regulatory framework does not
include consistent or readily enforceable requirements to address
worker fatigue;
(4) Reviews of industry control of work hours have repeatedly
identified practices that were inconsistent with the NRC's Policy on
Worker Fatigue, including excessive use of work hours and work-hour
limit deviations;
(5) The current regulatory framework includes requirements that are
inadequate and incomplete for effective fatigue management;
(6) Ensuring effective management of worker fatigue through
rulemaking would substantially enhance the effectiveness of FFD
programs, but additional orders are not presently warranted to ensure
adequate protection of public health and safety or the common defense
and security; and
(7) Addressing the fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the U.S.
Each of these considerations is discussed in greater detail below.
(1) Fatigue and decreased alertness can substantively degrade an
individual's ability to safely and competently perform his or her
duties.
The NRC previously noted in its ``Policy Statement on the Conduct
of Nuclear Power Plant Operations,'' dated January 24, 1989, (54 FR
3424), that ``nuclear power plant operators on each shift must have
knowledge of those aspects of plant status relevant to their
responsibilities to maintain their working environment free of
distractions, and using all their senses, be alert to prevent or
mitigate any operational problems.'' The degradation in an individual's
cognitive functioning resulting from inadequate rest includes, but is
not limited to, a reduced ability to sustain attention; maintain
situational awareness; make timely and conservative decisions;
communicate; and work effectively as a team member. Such degradations
in performance, if exhibited by individuals performing risk-significant
functions, can adversely affect the safety and security of a nuclear
power plant.
The NRC has evaluated the research available on the degradation of
worker abilities that are important to safe plant operation. The
research supports the fatigue management provisions in Subpart I. Many
of the specific research citations are listed in detail in Section VI.
The following is a discussion of the fundamental concerns associated
with worker fatigue, and some of the overall research that forms the
basis for the integrated fatigue management approach in Subpart I.
Many studies have shown that fatigue impairs human alertness and
performance (e.g., Alluisi and Morgan, 1982; Rosa, 1991; Scott, 1990;
Dinges, 1992; Dinges, 1995; Dawson and Reid, 1997; Bobko, et al., 1998;
Harrison and Horne, 2000; Williamson and Feyer, 2000). The lack of
adequate days off and extended workdays (overtime) can result in a
cumulative sleep debt (i.e., the difference between the amount of sleep
an individual needs and the amount of sleep that individual actually
obtains) and performance impairment (Webb and Agnew, 1974; Baker, et
al., 1994; Colquhoun, et al., 1996; Tucker, et al., 1999; Williamson
and Feyer, 2000; Department of Transportation (DOT), May 2, 2000, 65 FR
25546). Across a broad range of industries, studies concerning extended
work hours suggest that fatigue-induced personnel impairment can
increase human error probabilities by a factor of more than 2 to 3
times (Hanecke, et al., 1998; Colquhoun, et al., 1996; Akerstedt, 1995;
U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000, 65 FR
25544).
Studies of the nuclear power industry indicate that normal daily
variations in alertness associated with human circadian rhythms (i.e.,
physiological processes that vary on an approximate 24-hour cycle) may
be responsible for daily variations in the incidence of personnel
errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;
Maloney, 1992). The findings of these studies are consistent with the
results of a survey of more than 100 nuclear power plant shift
supervisors--over 90 percent stated that they notice times of day, and
days in the schedule, during which control room operators are less
alert, less vigilant, or make more mistakes (Baker, et al., 1990 [EPRI
NP-6748]). These studies suggest that, despite safeguards to ensure
correct and reliable human performance, factors that influence
alertness may increase the incidence of human errors in nuclear power
plants.
Fatigue has generalized effects on human performance capabilities,
and is associated with performance decrements at a base level, across a
variety of tasks (Dinges, 1995). Fatigue can impair both physical and
cognitive (i.e., mental) functioning.
Generally, cognitive task performance is affected more readily by
fatigue than physical or psychomotor tracking performance (Krueger,
1989; 1991). General cognitive fatigue decreases an individual's
ability to remain alert, process complex information, and correctly
grasp a complex set of circumstances. Fatigue has been shown to cause
memory problems, slowed responses, lapses and false responses
(Williams, et al., 1959; Morgan, et al., 1974; Dinges, 1992; Dinges,
1995). Many of the cognitive tasks performed by nuclear power plant
personnel that are important to the protection of public health and
safety and the common defense and security rely on their ability to
sustain attention, analyze problems, make clear decisions, and
communicate and work as a team. The following effects of fatigue on
cognitive abilities are the primary focus of the proposed fatigue
management requirements:
(a) Sustaining attention--Vigilance and attention to detail are
fundamental for plant safety, whether an individual is operating or
maintaining equipment important to plant safety, performing
surveillance procedures in the plant, monitoring system status in the
control room, or monitoring plant security systems or barriers.
Tasks requiring sustained attention (e.g., vigilance tasks) are
among the most susceptible to fatigue-induced degradation (Monk and
Carrier, 2003). The sensitivity to fatigue of vigilance tasks is one of
the primary reasons that tests, such as the psychomotor vigilance task
(Dinges, et al., 1997; Doran, et al., 2001), are standard measurement
tools used in studies of the effects of sleep deprivation and fatigue.
Of particular note are research findings showing that, in operational
settings, individuals may experience periods of sleep up to a few
seconds (called microsleeps), during which they fail to respond to
external stimuli, and are completely unaware that these episodes have
occurred (Cabon, et al., 2003; Priest, et al., 2001; Summala, et al.,
1999).
(b) Decision-making--Conservative decision-making is a cornerstone
of safe nuclear power plant operations. Fatigue has been associated
with more risky strategies and decreases in the effort individuals
exert (Schellekens, et al., 2000). Furthermore, Harrison and Horne
(2000) reviewed the impact of sleep deprivation on decision-making and
[[Page 50456]]
reported that, contrary to popular belief, sleep deprivation impairs
decision-making even if individuals try to compensate for lack of sleep
when responding to heightened stimulation. As noted by Cabon, et al.
(2003), studies have shown reductions in aircrew alertness, even during
the critical descent phase. These findings suggest that the alerting
stimuli of off-normal conditions (e.g., landing an airplane,
acknowledging control room annunciators) may not fully negate the
effects of fatigue on performance. The National Transportation Safety
Board (NTSB) reviewed the performance of flight crews involved in 37
major accidents and found that those crew members who had been awake
longer than 12 hours before their accidents made more errors overall,
and specifically more tactical decision errors, than did crew members
who had been awake for less time (NTSB, 1994).
(c) Problem solving--Perseveration is a term used to describe poor
problem solving performance, characterized by an individual or group of
individuals maintaining a faulty diagnosis or mitigation plan despite
contrary information. An example of perseveration from the nuclear
power industry was the initial response by plant operators to events at
Three Mile Island Unit 2 in 1979. The operators' initial response was
based on a faulty diagnosis of the plant condition (the operators
failed to recognize they were dealing with a loss of coolant accident),
which the operators maintained throughout the first 2 hours of the
event in the face of numerous conflicting indications. Many factors
contributed to human performance problems during the Three Mile Island
accident and the NRC is not suggesting that operator fatigue was a
contributing factor. However, fatigue is one factor that has been found
to contribute to this type of performance degradation (Harrison and
Horne, 2000), which may have serious consequences for public health and
safety. Sleep-deprived workers fail to appropriately allocate
attention, set task priorities, or sample for sources of potentially
faulty information (Hockey, 1970; Krueger, 1989). Mental fatigue also
contributes to decreased originality and flexibility in problem solving
and sub-optimal planning (Van der Linden, et al., 2003; Lorist, et al.,
2000; Horne, 1988).
(d) Communication and teamwork--Fatigue affects skills important to
written and oral communication and teamwork. Fatigue degrades speech
articulation, verbal fluency, grammatical reasoning (the ability to
process oral and written instructions), and memory (Harrison and Horne,
1997; 1998). Studies of individuals in simulated combat and command and
control conditions have shown that fatigue slows the encoding,
decoding, and transcription of information (Banderet, 1981; Angus and
Heslegrave, 1985). Fatigued individuals also tend to be less
communicative and have greater difficulty performing multiple tasks
concurrently, as demonstrated in simulated aircraft cockpit tasks
requiring monitoring and communications (Pascoe, et al., 1995; Harrison
and Horne, 2000). These effects have been found in the analysis of
incidents and accidents. In a study of major aircraft accidents, crews
that had been awake longer (an average of 13.8 hours for captains and
13.4 hours for first officers) made significantly more procedural and
tactical decision errors than crews that had been awake for a shorter
period (an average of 5.3 hours for captains and 5.2 hours for first
officers) (NTSB, 1994). Similar to control room personnel in nuclear
power plants, aircraft cockpit crews make extensive use of secondary
checks to verify that decisions and performance are correct, and to
mitigate the consequences of errors. Although the difference was not
statistically significant, analysis of the crew errors indicated that
crews that had been awake longer made nearly 50 percent more errors in
failing to challenge a faulty action or inaction by another crew
member. These studies highlight how fatigue cannot only degrade the
fitness of an individual, but also the overall performance of a crew.
Although fatigue has long been widely recognized as degrading
performance, recent research has helped characterize the magnitude of
these effects relative to a historical FFD concern: impairment from
alcohol intoxication. The current provisions in 10 CFR Part 26 prohibit
the use of alcohol on site and within several hours before a tour of
duty, and establish alcohol testing requirements for personnel on duty.
The NRC established these requirements based on the recognition that
alcohol can have significant adverse effects on a worker's ability to
safely and competently perform his or her duties. Recent studies have
shown that fatigue can cause performance degradations that are
comparable to the levels observed from blood alcohol concentrations
(BACs) in excess of those that would result in a positive breath
alcohol test under the current provisions of 10 CFR Part 26. In those
studies, individuals who were awake for 17-19 hours had cognitive and
psychomotor performance comparable to individuals with a BAC of 0.05
percent (Dawson and Reid, 1997; Williamson and Feyer, 2000). Part 26
establishes a breath alcohol cutoff level of 0.04 percent. The NRC
considers the insight that fatigue can impair a worker at levels
comparable to those prohibited for alcohol to be particularly
significant.
(2) Conditions that contribute to worker fatigue are prevalent in
the U.S. nuclear power industry.
Fatigue may result from an individual remaining awake continuously
for an excessive period of time, or from the individual obtaining an
inadequate amount or quality of sleep, or both. Conditions that
contribute to worker fatigue include:
(a) Extended work shifts with five or more consecutive work days--
Although the effects of shift length on worker performance is
influenced by the nature of the task, various studies have shown that
task performance declines after 12 hours on a task (Rosa, 1991;
Folkard, 1997; Dawson and Reid, 1997). Other studies have shown that
the relative risk of having an accident increases dramatically after 9
consecutive hours on the job (Colquhoun, et al., 1996; Hanecke, et al.,
1998; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000,
65 FR 25544). The effects of extended working hours on worker
performance can be exacerbated when many extended shifts are scheduled
in succession.
The use of 12-hour shifts has become increasingly common at U.S.
nuclear power plants. Schedules that include 5 or more 12-hour shifts
in succession during routine operations are sometimes popular with
workers because they allow a long sequence of days off. However,
scheduling more than 4 consecutive 12-hour shifts is not a recommended
means of managing fatigue (Baker, et al., 1990 [EPRI NP-6748]; NUREG/
CR-4248, ``Recommendations for NRC Policy on Shift Scheduling and
Overtime at Nuclear Power Plants''). As noted in the 2000 Sleep in
America Poll, ``waking up unrefreshed'' was more likely to be reported
by individuals working more than 60 hours per week (58 percent vs. 42
percent of those working 41-60 hours per week and 39 percent of those
working 31-40 hours) (National Sleep Foundation, 2000).
During the public meetings described in Section V, industry
stakeholders noted that the use of 6 or more consecutive 12-hour shifts
is now standard practice during plant outages. In SECY-01-0113, the NRC
staff reported that more than 80 percent of the authorizations written
by licensees
[[Page 50457]]
to exceed the technical specification work hour limits during outages
were for exceeding 72 hours (e.g., six 12-hour shifts) in a 7-day
period. The NRC's more recent review of deviations authorized at six
plants for refueling outages during 2003 and 2004 also indicates that
deviations from the limit of 72 hours in 7 days continue to account for
more than 80 percent of the deviations authorized. During these
meetings, industry stakeholders also reported that, during outages,
some licensees have scheduled personnel for three or more weeks of
consecutive 12-hour shifts without intervening days off.
(b) Extensive Overtime--Many research studies report that excessive
working hours cause worker fatigue (Akerstedt, 1995b; Rosa, 1995;
Buxton, et al., 2002). The U.S. nuclear power industry makes extensive
use of overtime, creating a combined effect of long work hours with
reduced break periods. As noted in SECY-01-0113, at approximately one-
fourth of the sites, more than 20 percent of the personnel covered by
working hour limits work more than 600 hours of overtime annually. This
amount of overtime is more than two to three times the level permitted
for personnel at some foreign nuclear power plants and more than twice
the level recommended by an expert panel in 1985 (NUREG/CR-4248). In
SECY-01-0113, the NRC also noted that some licensees authorized
hundreds to several thousand deviations from the limits of 16 hours of
work in any 24-hour period, 24 hours of work in any 48-hour period, 72
hours of work in a 7 day period, and from the minimum break requirement
of 8 hours between work periods. The NRC also noted the continued
excessive use of such deviations in its survey of six plants in 2004.
(c) Shiftwork--The nuclear power industry is a round-the-clock
operation requiring individuals to be awake and working at times when
they would normally be asleep. Although individuals can function in
these circumstances, human alertness and task performance are
cyclically affected by a daily biological clock, which runs on about a
24-hour (circadian) cycle, as it assists in timing numerous
physiological and psychological phenomena (such as core body
temperature, the daily release of various hormones, mood swings, and
wake-sleep cycle) (Liskowsky, et al., 1991). The circadian trough, or
lowest levels of function reflected in, for example, alertness,
performance, subjective mood, and body temperature, occurs around 3
a.m. to 5 a.m., with many human functions showing reduced levels
between 12 a.m. and 6 a.m. Sleepiness is most severe between 3 and 5
a.m., with a less marked but significant expression again between 3 and
5 p.m.
There is a substantial scientific literature on circadian
variations in alertness that clearly demonstrates the significant roles
that worker fatigue, sleep loss, and circadian rhythms play in
contributing to errors and accidents (Kryger, et al., 1994; Akerstedt,
1995a; Dinges, 1995; Folkard, 1997; Comperatore and Krueger, 1990;
Miller and Mitler, 1997). These findings range from reduced response
speed on a variety of tasks, to missing warning signals, to minor
hospital incidents and accidents (Krueger, 1994). In addition, as
previously described in this section, circadian variations have also
been noted in studies of the incidence of personnel errors at nuclear
power plants (Bobko, et al., 1998; Dorel, 1996; Maloney, 1992) and
noted in observations by a large number of nuclear power plant shift
supervisors (Baker, et al., 1990 [EPRI NP-6748]).
In addition to causing individuals to perform work at periods of
depressed alertness, shiftwork also conflicts with circadian variations
in alertness by requiring individuals to sleep during naturally
occurring periods of increased cognitive arousal. Circadian rhythms,
and naturally occurring tendencies for sleep and wakefulness, do not
fully adapt to shiftwork schedules. In addition, daylight, noise and
the ``regular day'' schedules of other family members challenge the
ability of shiftworkers to obtain adequate rest. As a result,
shiftworkers generally obtain less sleep, and report a higher incidence
of sleepiness and sleep-related complaints. For example, in a survey of
1,154 U.S. adults, the National Sleep Foundation (NSF) found that
shiftworkers, on average, get less sleep (6 hours, 30 minutes) than
regular day workers (6 hours, 54 minutes). Almost half of the
shiftworkers they surveyed obtained less than 6.5 hours of sleep per
``night'' during the work-week, 30-90 minutes less than recommended by
most sleep experts. In comparison to regular day workers, shiftworkers
were more likely to be sleepy at work 2 or more days per week (34
percent vs. 23 percent) (National Sleep Foundation, 2000). Many studies
have demonstrated that decreased performance and increased errors and
accidents are associated with night work and are affected by varying
sleep schedules and durations of sleep periods (e.g., Balkin, et al.,
2000).
The challenge for shiftworkers to remain alert during the early
morning hours of a shift can be exacerbated by extended shift lengths,
overtime, and the inability of many shiftworkers to obtain adequate
sleep during the day (Hanecke, 1998). The powerful drive for sleep that
is associated with circadian factors, and the fact that shiftwork is a
daily influence on the alertness of all shiftworkers at nuclear power
plants, has been demonstrated by a number of recent events. For
example, there have been instances of operators falling asleep in the
control rooms at the Pilgrim nuclear power station (2004) and the test
and research reactor at the Massachusetts Institute of Technology
(2003), as well as a security officer falling asleep at the Braidwood
nuclear power plant while driving a patrol vehicle (2004), despite
these individuals recognizing the potential safety and disciplinary
consequences.
(d) Early start times and extended commutes--Although many plant
personnel do not work rotating shifts, start times before 7 a.m. can
interfere with a worker's ability to obtain adequate rest if the
schedule is not aligned with his or her circadian cycle and naturally
occurring tendency for sleep and wakefulness. In addition, long
commutes to remote work sites such as nuclear power plants, which are
frequently located in rural areas and distanced from major population
centers, contribute to the potential for fatigue associated with early
start times.
(e) Sleep disorders--Sleep disorders, such as sleep apnea,
insomnia, and restless leg syndrome (i.e., a condition that is
characterized by uncomfortable or unpleasant sensations in the legs,
causing an overwhelming urge to move them, often contributing to
difficulty in staying or falling asleep), are conditions that can
significantly reduce the quantity and quality of sleep that individuals
are able to obtain, affect an individual's ability to remain alert, and
ultimately degrade an individual's ability to safely and competently
perform his or her duties (Kryger, et al., 1994; Lewis and Wessely,
1992). These factors are not effectively addressed by limits on working
hours in the absence of other fatigue management practices. Although
the NRC does not have data for the incidence of sleep disorders that is
specific to U.S. nuclear power plant workers, in the general U.S.
population, such conditions are not uncommon. For example, the
prevalence of sleep apnea is estimated to be 4 percent for adult males
and 2 percent for adult females (Strollo and Rogers, 1996). The
incidence of sleep apnea may in fact be higher for shiftworkers at
power plants, as this condition is more common in middle-age adult
males than in the
[[Page 50458]]
general population. A survey by the NSF of 1,154 adults living in
households in the continental U.S. found self-reports of sleep apnea
were more common from shiftworkers than regular day workers (15 percent
vs. 9 percent) (National Sleep Foundation, 2000). Similarly, the NSF
found that shiftworkers reported a higher incidence of insomnia (66
percent vs. 55 percent) than regular day workers.
Although worker motivation can mitigate to a limited degree the
effects of fatigue, fatigue has a physiological basis, including
changes in glucose metabolism in the brain (Wu, et al., 1991; Thomas,
et al., 2000), and such changes are beyond the individual's control. In
addition, several studies have suggested caution with regard to the
ability of individuals to self-monitor their abilities to safely and
competently perform their duties when fatigued (Dinges, et al., 1997;
Belenky, et al., 2003; Akerstedt, 2003). These studies note that
individuals experience microsleeps without being aware of their lapses
in attention and underestimate their propensity for uncontrolled sleep
episodes. As a consequence, a worker's motivation to remain alert does
not provide reasonable assurance that an individual will be able to
safely and competently perform his or her duties.
Considering the above factors, the NRC believes that fatigue can
have a significant adverse effect on worker abilities. Further, the
likelihood of a nuclear power plant worker being impaired from fatigue
is not trivial, and potentially greater than the likelihood of
impairment from drugs and alcohol, which the NRC currently requires
licensees to address through their FFD programs. Therefore, the NRC
believes that regulatory action is warranted to ensure that fatigue is
adequately addressed through licensee FFD programs. Further, the NRC
believes that rulemaking is the appropriate regulatory action for the
following reasons:
(3) With the exception of orders limiting the work hours of
security personnel, the NRC's current regulatory framework does not
include consistent or readily enforceable requirements to address
worker fatigue.
The principal components of the current regulatory framework for
matters pertaining to working hours and fatigue for non-security
personnel are (a) NRC's Policy on Worker Fatigue, as issued on June 15,
1982, in GL 82-12, and (b) plant technical specifications related to
this policy statement, and (c) certain requirements of 10 CFR Part 26.
As part of the assessment of PRM-26-2, in which Barry Quigley
petitioned for rulemaking to establish enforceable requirements
addressing fatigue of workers at nuclear power plants, the NRC reviewed
and assessed the implementation and enforceability of the NRC's current
regulatory framework applicable to worker fatigue, including licensee
technical specification requirements for the administrative control of
work hours. This review was documented in detail in Attachment 1 to
SECY-01-0113. The NRC continued this evaluation during development of
this proposed rule, and the principal findings include:
(a) NRC's Policy on Worker Fatigue--NRC guidance documents do not
prescribe requirements. Guidance documents establish policy or provide
advice on meeting a regulatory requirement. As a result, the policy is
enforceable only to the extent that the guidelines have been
incorporated into a license condition or technical specification
requirements. For the three nuclear power plant sites who have not
incorporated the guidelines from the NRC's Policy on Worker Fatigue
into a license condition or technical specification requirement, the
guidelines are unenforceable. These plant sites have implemented the
concept using other administrative controls that the NRC has determined
to be adequate. However, had the NRC determined that the controls were
inadequate, it would have no basis for taking enforcement action.
(b) Technical Specifications--For those licensees who have
incorporated the NRC's Policy on Worker Fatigue into a license
condition or technical specifications, consistent enforcement is
complicated by the following factors:
--The language in plant technical specifications is largely advisory
(e.g., an individual should not be permitted to work more than 16 hours
straight) and key terms have not been defined. This deficiency results
in inconsistent interpretation and implementation of technical
specification requirements by licensees, as well as difficulty for the
NRC in enforcing the requirements. For example, many technical
specifications use the terms ``routine heavy use of overtime,''
``unforeseen problems,'' and ``temporary basis.'' The NRC has not
defined any of these terms and has not consistently pursued enforcement
on the basis of the amount or frequency of overtime authorized.
--The technical specifications have inconsistent levels of detail from
one nuclear power plant licensee to another. Only three-quarters of the
licensees' technical specifications include the quantitative working
hour limit guidelines of the NRC's Policy on Worker Fatigue.
--The technical specifications contain varying scopes of requirements.
Some plant technical specifications require periodic reviews of
overtime approvals to ensure that excessive hours have not been
assigned, while other technical specifications contain no equivalent
requirements. Although the observed variability in the controls does
not by itself present a safety concern, such variability is
inconsistent with establishing a uniform level of assurance that
personnel are not in a fatigued condition that could significantly
reduce their mental alertness and decision-making capability.
--Licensees have inconsistently interpreted the scope of personnel who
must be subject to the technical specification work hour limits. The
NRC's Policy on Worker Fatigue applies to personnel who are performing
safety-related functions. The NRC's review of work hour data gathered
by NEI regarding the work hours of personnel subject to the technical
specifications (Nuclear Energy Institute, 2000) identified variation in
the numbers and types of personnel covered by these controls. A limited
number of sites may not be applying work hour controls to all personnel
performing safety-related functions. At least two nuclear plant sites
do not apply the work hour controls to any maintenance personnel even
though GL 83-14, ``Definition of Key Maintenance Personnel
(clarification of GL 82-12),'' issued March 7, 1983, defined key
maintenance personnel to include individuals who work on safety-related
equipment.
--The basic measure used to determine whether an individual's work
hours are within or above the technical specification limits is not
implemented consistently from one nuclear power plant to another. Work
hours included within the limits at some nuclear power plants are not
included at others, effectively creating substantively different work
hour limits among plants.
(c) 10 CFR Part 26, ``Fitness for Duty Programs''--The general
performance objectives of Sec. 26.10 require that licensees provide
``reasonable assurance that nuclear power plant personnel * * * are not
* * * mentally or physically impaired from any cause, which in any way
adversely affects their ability to * * * perform their duties.''
[[Page 50459]]
Although 10 CFR Part 26 contains specific requirements pertaining to
alcohol and drug usage, it does not include prescriptive requirements
regarding fatigue. Rather, Sec. 26.20 uses general, non-mandatory
language to state that the FFD policy ``should'' address other factors
that can affect a worker's ability to safely and competently perform
his or her duties, ``such as mental stress, fatigue, and illness.'' As
a result, it is difficult for the NRC to justify a violation of the
regulation based on a licensee's failure to limit overtime hours. In
addition, without a numerical limit on overtime hours, or a provision
limiting overtime, a range of overtime practices could be viewed as
``reasonable,'' and therefore in compliance with the regulation.
In summary, the broad and non-prescriptive provisions of Part 26,
and the technical specifications and license conditions pertaining to
fatigue, in the absence of clearly defined terms or measures of
fatigue, make it difficult for the NRC to enforce worker fatigue
requirements and working hours limits in an effective, efficient, and
uniform manner that ensures that all licensees provide reasonable
assurance that workers are able to safely and competently perform their
duties. The NRC believes that a consistent fatigue management program
and its uniform implementation across the industry is essential, and
the most effective regulatory mechanism is to incorporate worker
fatigue into 10 CFR Part 26.
(4) Reviews of industry control of work hours have repeatedly
identified practices that were inconsistent with the NRC's Policy on
Worker Fatigue, including excessive use of work hours and work hour
limit deviations.
The policy states, in part, ``Enough plant operating personnel
should be employed to maintain adequate shift coverage without routine
heavy use of overtime.'' Surveys and expert panels have suggested that
tolerance for overtime is generally limited to 300-400 hours of
overtime per year (ADAMS Accession No. ML05270310; NUREG/CR-4248).
Baker, et al. (1994) reviewed the hours worked by nuclear power plant
operations, technical, and maintenance personnel during 1986, four
years after the NRC issued its policy. Based on a sample of 63 percent
of U.S. nuclear power plants operating at that time, Baker and
colleagues found that operations personnel averaged more than 500 hours
of overtime annually at 20 percent of the plants, and more than 700
hours of overtime at 9 percent of the plants. Technical personnel
averaged more than 500 hours of overtime annually at 30 percent of the
plants, and more than 700 hours of overtime at 18 percent of the
plants. Maintenance personnel averaged more than 500 hours of overtime
annually at 80 percent of the plants and more than 700 hours of
overtime at 14 percent of the plants.
The NRC's Policy on Worker Fatigue includes provisions for
licensees to authorize deviations from the NRC's work and rest
guidelines for individual workers in ``very unusual circumstances.'' On
June 10, 1991, following several NRC inspections noting concerns
related to licensee work hour control, the NRC issued Information
Notice (IN) 91-36, Nuclear Power Plant Staff Working Hours, to alert
licensees of potential problems resulting from inadequate controls to
prevent excessive working hours. The conditions cited in the notice
included an event attributed to fatigue, excessive use of deviations
and overtime, and overtime deviations authorized after the fact.
Subsequent NRC reviews completed in 1999 and 2001 have identified
continued problems with industry control of work hours. In 1999 the NRC
reviewed licensee event reports and NRC inspection reports from January
1994 through April 1999. The NRC found that only a few events of
limited risk significance had been attributed to fatigue. However, the
staff found several instances each year in which licensee use of
overtime appeared to be inconsistent with the general objectives or
specific guidelines of the NRC's Policy on Worker Fatigue.
The Nuclear Energy Institute (NEI) conducted a survey in the summer
of 2000 concerning industry control of work hours for personnel subject
to the technical specification requirements (letter dated August 29,
2000, from J.W. Davis, NEI, to G.T. Tracy, NRC, ADAMS Accession No.
ML003746495). Forty-seven sites responded to the survey, providing data
from 1997-1999. The NRC staff's review of the data is documented in
Attachment 1 to SECY-01-0113. The NRC evaluated the results of the
survey concerning overtime and found that 8 of 36 sites providing data
had more than 20 percent of the personnel covered by the policy working
in excess of 600 hours of overtime per year. Considering all plants
that provided data, the percentage of personnel working in excess of
600 hours of overtime increased from 7 percent in 1997 to 11 percent in
1999. The percentage of licensed operators working in excess of 600
hours increased from 13 percent in 1997 to more than 16 percent in
1999. The NRC believes these percentages represent excessive use of
overtime in the nuclear industry.
The NRC also reviewed the data collected by NEI concerning
deviations, which showed that approximately one-third of the
respondents were authorizing more than a thousand, to as many as 7,500,
deviations in a year to exceed the policy guidelines. The frequency of
deviations did not appear to be consistent with either the specific
guidelines or the general objective of the policy. As previously
described in this section, the policy permits deviations from the
guidelines in ``very unusual circumstances.''
Subsequent to the Commission's decision to initiate rulemaking for
worker fatigue, the NRC staff also obtained data from six sites in
2004. Those data indicated that between 95 and 603 deviations, with an
average of 311 deviations, were issued for individuals. The data were
provided by the six sites for each plant's most recent refueling outage
and one month of power operation, and therefore do not reflect the
total number of deviations issued for individuals during all of 2004,
except for one of the six sites that provided its deviation data (101
deviations) for all of 2004. Data on the deviations from 2004 are
reported in detail in Appendix 3 of the draft Regulatory Analysis. The
analysis is available as discussed above under the ADDRESSES heading.
Single copies may be obtained from the contact listed above under the
FOR FURTHER INFORMATION CONTACT heading. The NRC believes that licensee
use of deviations and overtime at some sites is excessive, and does not
represent the intent of the NRC's Policy on Worker Fatigue.
In addition to excessive work hours and work hour guideline
deviations, the NRC has recently identified other concerns related to
licensee policies and practices applicable to worker fatigue. On May
10, 2002, the NRC issued Regulatory Issue Summary (RIS) 2002-007,
``Clarification of NRC Requirements Applicable to Worker Fatigue and
Self-Declaration of Fitness-For-Duty.'' The NRC issued the RIS
following several allegations made to the NRC regarding the
appropriateness of licensee actions or policies related to individuals
declaring they are not fit due to fatigue. These concerns indicate a
need to ensure that individuals and licensees clearly understand their
responsibilities with respect to self-declarations of worker fatigue.
The proposed rule would establish requirements to address this need.
(5) The current regulatory framework includes requirements that are
inadequate and incomplete for effective fatigue management.
[[Page 50460]]
a. The NRC's Policy on Worker Fatigue did not establish clear
expectations for the control of work hours. As previously noted in this
section, the NRC did not define key terms of the policy, and, as a
consequence, implementation has been varied across the industry.
b. Certain policy guidelines and technical specification
requirements are inadequate for reasonable assurance that individuals
remain capable of safely and competently performing their duties. For
example, the requirement for an 8 hour break between work periods would
be revised to a 10 hour break. The basis for the need to revise this
break period is described in detail in Section VI with respect to
proposed Sec. 26.199(d)(2)(I).
Further, the specific work hour guidelines of the policy, and most
technical specification requirements for the administrative control of
work hours, are principally focused on acute fatigue, and do not
adequately address the longer term control of work hours and the
cumulative fatigue that can result from prolonged periods of extended
work hours. Acute fatigue results from restricted sleep, sustained
wakefulness, continuous task demands, or other issues over the past 24
hours or more. Cumulative fatigue results from inadequate rest over
consecutive sleep-wake periods when the worker obtains less sleep than
he or she requires. An individual incurs a sleep debt for each day or
night during which the worker obtains insufficient sleep. If the
individual continues to obtain insufficient sleep, this debt
accumulates over successive days, resulting in increasing fatigue and
impairment (Belenky, et al., 2003).
The inadequacy of the current regulatory framework for addressing
cumulative fatigue became particularly apparent in the months following
the terrorist attacks of September 11, 2001. As described in Section VI
with respect to proposed Sec. 26.199(f)(2), the NRC received numerous
allegations from nuclear security officers that certain licensees
required them to work excessive amounts of overtime over long periods
due to the post-September 11, 2001, threat environment. These
individuals questioned their readiness and ability to perform their
required job duties due to the adverse effects of cumulative fatigue.
The NRC reviewed the actual hours worked by security personnel and
determined that, in the majority of cases, individual work hours did
not exceed the guidelines specified in the NRC's Policy on Worker
Fatigue, but the review confirmed that individuals had been working up
to 60 hours per week for extended periods. The concerns expressed by
individuals regarding their FFD, in light of work schedules that did
not exceed the specific guidelines of the policy, as well as relevant
technical research supporting the basis for cumulative fatigue, led the
NRC to conclude that the work hour guidelines of the policy are
inadequate for addressing cumulative fatigue. The NRC obtained
additional worker feedback supporting this conclusion through a review
of worker fatigue concerns and work hours during a long-term outage at
the Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003,
dated March 31, 2004, ADAMS Accession No. ML040910335).
The comprehensive fatigue management approach in Subpart I,
Managing Fatigue, would establish controls to address cumulative
fatigue. Limits to mitigate cumulative fatigue for security personnel
were implemented by Order EA-03-038. The proposed rule would codify,
with limited changes, these requirements. Changes to those limits that
would be imposed by this rule are discussed in detail in Section VI,
which also includes a detailed discussion of the proposed limits and
other controls to mitigate cumulative fatigue for non-security
personnel.
c. The existing regulatory framework does not effectively ensure
that fatigue from causes other than work hours is addressed. Work hour
controls are necessary, but not sufficient, to effectively manage
worker fatigue. As a consequence, training and fatigue assessments are
essential. Worker fatigue, and its effects on worker alertness and
performance, can result from many causes in addition to work hours
(e.g., stress, sleep disorders, daily living obligations) (Rosa, 1995;
Presser, 2000). In addition, there are substantial individual
differences in the ability of individuals to work for extended periods
without performance degradation from fatigue (Gander, 1998; Van Dongen,
et al., 2004a; Van Dongen, et al., 2004b; Jansen, et al., 2003).
Proposed Subpart I, Managing Fatigue, would require a comprehensive
fatigue management program. One example would be the strengthening of
FFD training requirements concerning worker fatigue. This would improve
behavioral observation and assessment of worker fatigue, self-
declaration as a means for early detection of fatigue, worker self-
management of fatigue, the ability of workers to obtain adequate rest
on a shiftwork schedule, and licensee use of effective fatigue counter-
measures.
(6) Ensuring effective management of worker fatigue through
rulemaking would substantially enhance the effectiveness of FFD
programs, but additional orders are not presently warranted to ensure
adequate protection of public health and safety or the common defense
and security.
Adequate protection of public health and safety and the common
defense and security are ensured under the current regulatory
framework, including Order EA-03-038 (for security personnel), the
NRC's Policy on Worker Fatigue, and licensee technical specification
requirements. Licensee FFD programs currently include behavioral
observation programs to identify individuals whose behavior indicates
they may not be fit to safely and competently perform their duties, and
ensure that those individuals are removed from duty until any question
regarding their fitness has been resolved. The current work hour
controls, in conjunction with licensee behavioral observation programs,
automatic reactor protection systems and other administrative controls
on worker activities (e.g., post-maintenance testing, peer checks,
independent verifications) ensure adequate protection of public health
and safety and the common defense and security. However, there are
substantial limitations to the current regulatory framework, as
detailed in this section. Therefore, although the current regulatory
framework provides adequate protection, including work hour controls in
10 CFR Part 26 would provide a substantial increase in public health
and safety and the common defense and security. The NRC is proposing to
incorporate worker fatigue provisions into Part 26 in light of the
substantial increase in safety and security that is expected to result.
(7) Addressing fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the U.S.
The NRC reviewed the current and proposed Federal limits on work
hours for nuclear plant workers in eight other countries, as well as
six other industries in the United States and Canada. Although many
factors influence specific regulatory limits, and requirements for
other industries should be considered in context, the NRC found that
the NRC's current guidelines are the least restrictive among those
reviewed.
The work hours of nuclear power plant personnel in other countries
are largely based on labor laws or union agreements. With the exception
of Spain, which has limits consistent with the NRC's Policy on Worker
Fatigue, each of the other eight countries has
[[Page 50461]]
more stringent requirements. The more stringent requirements have
largely preempted the need in those countries for regulation of work
hours based on nuclear safety concerns.
The Department of Transportation (DOT) has established regulatory
limits on the work hours of pilots, air traffic controllers, and
maintenance personnel in the commercial aviation industry (14 CFR Parts
121 and 135), in the maritime industry (46 U.S.C. 8104; 46 CFR Parts
15.705, 15.710 and 15.111), in the rail industry (49 U.S.C. 211; 49 CFR
Part 228), and for drivers of heavy trucks in the commercial trucking
industry (49 CFR Part 395). The DOT recognized that fatigue can
substantively degrade the ability of individuals to perform these
duties and, therefore, promulgated regulatory requirements for each of
these modes of transportation in keeping with the department's mission
to protect public safety. In the late 1980s and early 1990s, the
National Transportation Safety Board (NTSB) identified equipment
operator fatigue as a significant issue affecting all transportation
modes (Beal and Rosekind, 1995). As a result, DOT classified operator
fatigue management as a DOT ``Flagship Initiative'' and several
proactive fatigue management activities ensued across the
transportation industries (e.g. U.S. DOT, 1995; Rogers, 1996, 1997;
Hartley, 1998; Carroll, 1999).
In 1999, the NTSB evaluated DOT's decade of efforts on operator
fatigue (NTSB, 1999). Dissatisfied that enough was being done, NTSB
subsequently offered DOT three recommendations: (1) Expedite a
coordinated research program on the effects of fatigue, sleepiness,
sleep disorders, and circadian factors on transportation safety; (2)
develop and disseminate educational materials for transportation
industry personnel and management regarding shift work, work rest
schedules, and proper regimens of health, diet, and rest; and (3)
review and upgrade regulations governing hours of service for all
transportation modes to assure they are consistent and incorporate the
results of the latest research on fatigue and sleep issues (NTSB,
1999).
On April 28, 2003, the DOT issued revised hours-of-service
regulations to require motor carriers to provide drivers with better
opportunities to obtain sleep. Among other provisions, the regulations
(1) increase the required off-duty time from 8 to 10 consecutive hours;
(2) prohibit work after the end of the fourteenth hour after the driver
began work; and (3) require long break recovery periods to prevent
cumulative fatigue (68 FR 22456-22517; April 28, 2003).
Nuclear power plant licensees in the U.S. have sometimes asserted
that the characteristics of the work tasks in nuclear power plants
differ from other occupations that have work hour controls (e.g.
transportation equipment operators); therefore information from other
occupations may not be applicable. In addition, licensees have
suggested that the level of automation in nuclear power plants provides
an important barrier to human errors resulting from fatigue, and that
the amount of control room crew interaction and oversight of operators'
actions assures that fatigue-induced errors will be detected and
corrected before they have an opportunity to impact plant operations.
The NRC concurs that requirements for other industries should be
considered in context. Nevertheless, the fact that other federal
agencies with a safety mission have established regulations to address
fatigue is relevant for several reasons.
First, the human need for sleep and the deleterious effects of
sleep deprivation have a physiological basis (e.g., changes in brain
glucose metabolism) that is independent of the nature of the work being
performed (Wu, et al., 1991). Second, circadian variations in alertness
and performance, and the underlying changes in physiological processes,
have been observed in individuals performing a wide range of tasks
across many industries (Kecklund, et al., 1997). For all individuals,
time since awakening, the time of day, and the amount of prior sleep
that an individual obtains relative to his or her sleep needs are
primary determinants of fatigue and the need for sleep.
The NRC acknowledges that task characteristics and time on task may
exacerbate the effects of fatigue on the ability of individuals to
remain alert. For example, a concern for task-specific effects is
reflected in the DOT hours-of-service regulations for commercial truck
drivers, which establish a daily limit on driving time of 11 hours per
day. This limit is in addition to the requirements prohibiting driving
after 14 hours on duty and mandating minimum 10-hour break periods,
which reflect the human physiological need for rest that is necessary
to maintain performance (68 FR 22456-22517; April 28, 2003).
By comparison to driving a truck, the characteristics of some jobs
in nuclear power plants (e.g., reactor operator) permit greater freedom
of movement and social interaction, which may serve to temporarily
mitigate the effects of fatigue on alertness. However, there is no
evidence to indicate that worker motivation or the stimulating effects
of the job or environment alter the underlying physiological processes.
Although crew interactions and other job characteristics may serve to
bolster worker alertness temporarily, environmental stimulation only
masks individuals' physiological need for sleep. Removing the
stimulation (e.g., transitioning from the activity of shift turnover to
monitoring steady state plant operations during a night shift) will
increase the potential for lapses in attention and uncontrolled sleep
episodes among individuals who may be partially sleep deprived or
otherwise fatigued.
Another consideration regarding the relevance of other regulations
limiting work hours is that adverse fatigue effects are observed across
a broad range of cognitive functions in addition to alertness. Whereas
crew interactions may help sustain alertness, sleep deprivation and
sustained periods of wakefulness continue to degrade other cognitive
functions (e.g., memory and decision making) and elements of
performance that are important to safe nuclear plant operations, such
as communications and following written and oral instructions. For
example, as discussed in paragraph D(1)(d) of this section, studies of
crew performance in critical phases of commercial aircraft flight
(e.g., take-off and landings) and in simulated battle command station
operations have shown fatigue-related degradations in performance
despite the stimulation of the interactions, the intense level of
activity, and the implications of degraded performance for the loss of
human life. Regulations limiting work hours in other industries that
use operating crews (e.g., aviation) and allow greater freedom of
movement than trucking (e.g. maritime) are consistent with this
understanding of the broad effects of fatigue on cognitive performance.
There is no reason to believe that nuclear power plant workers'
physiological processes and the adverse effects of fatigue on their
abilities to perform their job tasks would differ. In addition, the
notion that human performance practices in the nuclear industry prevent
fatigue-related performance decrements from resulting in human errors
is not supported by studies that have shown circadian variations in
performance at nuclear power plants (Bobko, et al., 1998; Dorel, 1996;
Maloney, 1992).
The NRC acknowledges that the nuclear power industry is perhaps
unique, relative to many other industries, in its use of automated
safety systems to protect against the
[[Page 50462]]
consequences of equipment failure and human error. Nevertheless,
reliable human performance remains an essential element in the
protection of public health and safety and the common defense and
security. Current NRC requirements, such as the minimum on-site
staffing requirements of 10 CFR 50.54(m) and minimum security staffing
requirements in site security plans, are predicated on the expectation
that all personnel in these positions are fit for duty and are able to
safely and competently perform their duties. As a consequence, the NRC
does not consider the use of automated safety systems to be an
appropriate basis for permitting conditions that could allow fatigue to
degrade the important line of defense of reliable human performance.
Further, despite automated systems, the contribution of human error to
risk in operating events continues to be notable (NUREG/CR-6753,
``Review of Findings for Human Error Contribution to Risk in Operating
Events'').
Because the NRC concurs that task characteristics are an
appropriate consideration, the proposed rule would differ from other
Federal agencies' requirements with respect to specific work hour
requirements and would require licensees to consider task
characteristics when authorizing any waiver from the work hour
controls. Nevertheless, the NRC believes that it remains relevant that
other Federal agencies with public safety missions have chosen to
address worker fatigue through regulation.
In summary, the NRC believes that the proposed requirements in
Subpart I will provide a substantial increase in the protection of
public health and safety and common defense and security. In
determining the provisions of this proposed rule, the NRC has taken
into consideration the effects of fatigue on human performance, the
specific work practices of the nuclear power industry that both
mitigate and contribute to fatigue, the inadequacy of the current
regulatory framework, the excessive hours currently worked by many
nuclear power plan personnel, and the relevant research and practices
of other industries and countries for regulating work hour limits. In
addition, many public meetings were held with the nuclear industry and
the public to discuss draft provisions for the proposed rule. These
interactions are discussed in detail in Section V. The specific basis
for each provision of the fatigue management portions of the proposed
rule are discussed in Section VI.
The proposed requirements for managing fatigue will provide a
substantial increase in the protection of public health and safety and
common defense and security by:
(1) Establishing specific, integrated, comprehensive, and
enforceable requirements for the effective prevention, detection, and
mitigation of worker fatigue;
(2) Ensuring that personnel who perform functions that are
significant to the protection of public health and safety or the common
defense and security are subject to appropriate work hour controls,
including: individuals performing risk significant operations or
maintenance duties; health physics, chemistry, and fire brigade duties
important to emergency response; and individuals performing security
duties important to maintaining the security of the plant;
(3) Establishing work hour controls that provide increased
assurance that workers will have adequate opportunity for rest and that
deviations from the work hour limits will only be authorized as
necessary for plant safety or security and following appropriate
assessment of the worker's ability to safely and competently perform
his or her duties;
(4) Ensuring that work hour deviations are only permitted when
necessary for plant safety or security, and following assessment of the
worker's ability to safely and competently perform his or her duties;
(5) Establishing controls to prevent cumulative fatigue that can
result from consecutive weeks of extended work hours;
(6) Ensuring workers are provided with sufficient break periods to
provide for adequate opportunity for sleep to mitigate acute and
cumulative fatigue;
(7) Ensuring that, in addition to work hours, other factors that
can affect worker fatigue and the ability of workers to remain alert
are adequately addressed through licensee FFD programs;
(8) Encouraging effective fatigue management by permitting
licensees to use alternate measures for prevention and mitigation of
fatigue; and
(9) Strengthening FFD training requirements concerning worker
fatigue. This would improve behavioral observation and assessment of
worker fatigue; self-declaration as a means for early detection of
fatigue; worker self-management of fatigue; the ability of workers to
obtain adequate rest on a shiftwork schedule; and licensee use of
effective fatigue counter-measures.
V. Summary of Public Interactions and Comments
In preparing this proposed rule, the NRC has considered comments
received by OMB and the NRC on the prior Part 26 final rule affirmed by
the Commission in a SRM dated December 4, 2000, and subsequently
submitted to the Office of Management and Budget (OMB) for a clearance
under the Paperwork Reduction Act. Those comments and responses to them
are provided in Section V. A.
The NRC has also considered feedback received from industry, as
well as other interested parties and members of the public in preparing
this proposed rule. The NRC held 11 stakeholder meetings on the drug
and alcohol testing portions of the rule during 2001-2004, and held 13
stakeholder meetings on the fatigue portion of the rule during 2002-
2003. Subsequent to the Commission's decision to combine the two
rulemaking efforts, the NRC held 1 stakeholder meeting on the combined
rule in July, 2004, and 2 subsequent meetings on the fatigue provisions
of the combined rule in August and September, 2004.
Throughout the time the meetings were being held, drafts of
proposed rule language, regulatory and backfit analysis data, and other
pertinent information were made available to the public on the internet
,as announced in the Federal Register (67 FR 7093) on February 15,
2002. Feedback was received from stakeholders both through the public
meetings and the NRC's rulemaking Web site at http://ruleforum.llnl.gov. Summaries of these meetings, and any comments provided
through the Web site are available at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=BQ_PETITION&st=plan plan for meetings and comments on
the fatigue portions of the rulemaking prior to 2004, and at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=Part26_risk&st=risk for
meetings and comments on the drug and alcohol testing portions of the
rulemaking, and on the fatigue portions of the rulemaking subsequent to
the Commission's decision to combine the rulemakings in 2004. Address
questions about our rulemaking Web site to Carol Gallagher (301) 415-
5905; e-mail [email protected].
These interactions with stakeholders were a significant benefit to
the NRC in developing the language for the proposed rule in a manner to
ensure it was clearly understandable, could be consistently
interpreted, and did not result in unintended consequences. Many of the
stakeholders' comments directly resulted in proposed changes. Where a
comment was included in a proposed provision, the comment is discussed
in Section VI.
Many comments were received during the years the meetings were
held, and the draft proposed rule language was
[[Page 50463]]
changed and re-posted to the web numerous times. Each comment received
during these meetings, but not included in the proposed rule text, is
not discussed and responded to in detail, given that the NRC is issuing
a new proposed rule for formal public comment. However, the most
significant comments that were not incorporated are discussed in
Section V. B of this document.
A. Public Comments Submitted to OMB on 2000 Final Rule and Responses
The comments below were received by OMB and the NRC on the prior
Part 26 final rule affirmed by the Commission in a SRM dated December
4, 2000, and subsequently submitted to OMB for a clearance under the
Paperwork Reduction Act. The NRC's responses follow each comment.
Industry Comment 1: Rule should allow combining partial samples to
get the required volume for HHS analysis. Otherwise, it [the Regulatory
Analysis] should reflect an added expense with a reduced gain.
Response: New provisions in Sec. 26.109, ``Urine specimen
quantity,'' prohibit licensees from combining partial samples because
this practice may falsely lower the concentration of a drug or
adulterant. Further, HHS and DOT do not permit this practice.
Additionally, comments on the previous proposed rule objected to
combining specimens for the same reason. However, the proposed rule
would lower the required specimen quantity from a minimum of 60
milliliters (mL) to 30 mL. NRC discussions with representatives of HHS-
certified laboratories have indicated that advances in testing
technologies allow accurate and reliable testing of 15 mL specimens.
The NRC has proposed 30 mL, which would allow the HHS laboratory
sufficient specimen quantity for retesting, if needed. Because the
required specimen quantity has been reduced by at least one-half, there
should be few instances in which a donor is unable to produce the
necessary quantity and, therefore, few instances in which additional
costs would be incurred.
Industry Comment 2: Medical professionals other than a licensed
physician should be allowed to determine if a history of substance
abuse ``raises a concern.''
Response: The proposed rule in Sec. 26.187 would add a position
called the ``Substance Abuse Expert'' (SAE), adapted from the related
DOT regulations. The SAE need not be a licensed physician, but would be
required to have extensive expertise, such as a licensed or certified
social worker, psychologist, or others listed in Sec. 26.187(b), and
additional qualifications specifically related to substance abuse
disorders. The SAE would be authorized to make a determination of
fitness in at least circumstances: (1) when an individual has violated
the substance abuse provisions of a licensee's or C/V's FFD policy,
including, but not limited to a first positive drug test result; (2)
when there is a concern that an individual may be impaired by the use
of a substance; or (3) for an applicant for authorization when the
self-disclosure, the suitable inquiry, or other sources of information
identify potentially disqualifying FFD information (PDFFDI) about the
applicant.
Industry Comment 3: Reevaluate NRC's regulatory analysis indicating
a $27 million savings in light of industry's estimate of a $8 million
cost increase.
Response: A detailed reevaluation of the drug and alcohol
provisions, based in part on data obtained from NEI, still indicates a
savings to industry of $116 million-$183 million (7 percent--3 percent
discount rate) present value. The evaluation of the proposed Part 26
provisions as a whole, including the proposed worker fatigue
provisions, indicates a cost to industry of $469 million-$730 million
(7 percent--3 percent discount rate) present value. A draft regulatory
analysis was provided to industry and other stakeholders during the
public meetings held in 2004. Comments received have been considered in
developing the regulatory analysis for this proposed rule.
Industry Comment 4: New rule requires audits of [HHS] certified
labs.
Response: The proposed rule includes additional language in
proposed Sec. 26.41 to clarify the NRC's intent that audits of
certified labs may be shared among licensees and that licensees are not
required to audit areas that are covered by the HHS certification
process. Additionally, organizations that do not routinely provide FFD
services to a licensee or C/V, such as local hospitals or a substance
abuse treatment facility, would be exempt from the annual audit
requirement.
Industry Comment 5: Rule includes FFD personnel in program.
Response: The NRC continues to agree with the original intent of
the rule, which was that personnel who administer FFD programs must be
covered by 10 CFR Part 26. However, during meetings, stakeholders
discussed the numerous logistical difficulties associated with covering
FFD program personnel. As a result, the proposed rule includes a number
of related language adjustments.
Specifically, new language in proposed Sec. 26.25(a)(4) would
clarify the NRC's intent that FFD program personnel must be subject to
the program. Proposed Sec. 26.25(a)(4)(I) through (v) would be added
to identify the FFD program personnel who must be subject to the FFD
program, based upon their job responsibilities. Proposed Sec.
26.25(b)(1) would exempt individuals who may provide an FFD service to
a licensee or other entity in special circumstances, and who meet all
of the following three criteria: (1) They are not employed by the
licensee or C/V, (2) they do not routinely provide services to the
licensee's or other entity's FFD program, and (3) they do not normally
work at a licensee or other entity's facility. Personnel who meet the
three criteria specified in proposed Sec. 26.25(b)(1) would be exempt
because the limited nature of their involvement with the FFD program
makes it unlikely that they would be subject to coercion or influence
attempts to subvert the testing process.
In addition, new language in Sec. 26.31(b)(2) would permit FFD
program personnel who are distant from a licensee site to be tested at
a local facility that meets DOT requirements, including audits.
Permitting these FFD program personnel to be tested at local collection
sites that follow similar procedures would be adequate to meet the goal
of ensuring their continuing honesty and integrity, while addressing
some logistical concerns posed by stakeholders.
Industry Comment 6: The term, ``history of substance abuse,'' is
pejorative and may incorrectly label some workers in the nuclear
industry as substance abusers.
Response: Based upon further discussions with stakeholders, the NRC
developed a greater appreciation for the connotations of the term,
``history of substance abuse,'' and agreed that the term has too many
pejorative implications. Therefore, the proposed rule would entirely
eliminate the use of this term. The rule language no longer discusses
this issue in terms of an individual's personal characteristics.
Rather, the language focuses on the type of information that would
trigger a determination of fitness. This information is referred to as
``potentially disqualifying FFD information'' (PDFFDI), which is
consistent with terminology used in access authorization programs.
Industry Comment 7: History of substance abuse creates a new class
of workers and no relief.
Response: As noted above, the concept, ``history of substance
abuse,''
[[Page 50464]]
has been eliminated in the proposed rule. The proposed rule would
provide relief to individuals with PDFFDI in three ways. First,
individuals would be required to self-disclose PDFFDI that is related
to events that occurred only within the past 5 years. This provision
provides relief from the current rule, which requires individuals to
self-disclose certain adverse events every time they apply for
authorization, no matter how long ago the adverse events occurred.
Second, licensees would be permitted to accept a determination of
fitness conducted by a previous licensee and a favorable termination of
authorization for an individual who had any PDFFDI that was addressed
and resolved under a previous Part 26 program. This provision also
provides relief from the current rule, which requires the licensee to
conduct a determination of fitness for any individual who has ever been
denied access or had access terminated unfavorably, no matter how long
ago the event occurred or whether there is evidence that the individual
has been rehabilitated. Licensees would be permitted to conduct another
determination of fitness, but would not be required to do so, if the
individual's last period of authorization was terminated favorably.
Third, licensees would be permitted to accept responsibility for
continuing any treatment and followup testing plans that a previous
licensee implemented for an individual, rather than conducting a new
determination of fitness and developing new treatment and testing
plans. These provisions protect the rights of individuals who have
successfully resolved or are resolving a substance abuse-related
problem as well as reduce the regulatory burden on the individuals and
licensees.
Industry Comment 8: History of substance abuse creates a tracking
burden.
Response: As noted above, the concept, ``history of substance
abuse,'' would be eliminated in the proposed rule. Further, the current
rule requires licensees to maintain records and share information
related to denials and unfavorable terminations of authorization in
Sec. 26.27(a)(3). Therefore, the proposed rule's requirements for
licensees to maintain records and share information related to PDFFDI
would not create a new tracking burden and are consistent with the
access authorization Order.
Industry Comment 9: Change the opiate cutoff level of 300 ng/mL to
the HHS standard of 2000 ng/mL.
Response: The proposed rule now includes the 2000 ng/mL HHS cutoff
level for opiates. Discussions with HHS indicate that the HHS staff's
rationale for changing the cutoff level to 2000 ng/ML provides
sufficient protection for public health and safety from individuals who
may be abusing opiates.
Industry Comment 10: It is impossible to complete all suitable
inquiries within 72 hours.
Response: Consistent with the access authorization Order, which the
Commission issued to nuclear power reactor licensees on January 7,
2003, the proposed rule would eliminate provisions for routine
temporary access. Therefore, the proposed rule would eliminate the
requirement in the Affirmed Rule for a 72-hour turnaround on a suitable
inquiry prior to granting temporary access.
Industry Comment 11: Rule requires verification of all employment
periods, including less than 30 days.
Response: The proposed rule incorporates feedback received through
stakeholder meetings. The revised provisions specify employers required
to be addressed during the suitable inquiry for several different
cases, including applicants for initial authorization, updated
authorization, or reinstated authorization. The employers required to
be addressed vary for each of these situations, and are specified in
proposed Sec. Sec. 26.63 and 26.69. In developing this proposed
section, the NRC took into account documented substance abuse
recidivism rates (highest within the first year following treatment,
continuing at a somewhat lower rate for 3 years post-treatment, and
decreasing again at 5 years) and stakeholder feedback.
Stakeholders have indicated that employers are generally reluctant
to provide any information other than dates of employment, but that
more recent employers are more likely to disclose adverse information
than employers from previous years. Therefore, the NRC has determined
that requiring every employer from the past 5 years to be contacted for
all persons is both unnecessary and an unwarranted regulatory burden.
Thus, for initial authorization, the employment check is to be
conducted with every employer, regardless of the length of employment,
for the past year, and with each employer by whom the individual claims
to have been employed the longest in each calendar month for the
previous 2 years. For authorization updates, the employment check is to
be conducted with every employer, regardless of the length of
employment, for the past year, and with each employer by whom the
individual claims to have been employed the longest in each calendar
month for the remaining time since authorization was terminated. For
authorization reinstatements, the employment check is to be conducted
with each employer by whom the individual claims to have been employed
the longest in each calendar month since authorization was terminated.
For individuals who have had a substance abuse problem, however, Sec.
26.69 requires a suitable inquiry for the applicable period specified
by Sec. 26.63, as well as obtaining any records that other licensees
or other entities may have developed relating to any potentially
disqualifying FFD information about the individual.
Industry Comment 12: Allow credit for prior licensee's suitable
inquiry.
Response: Proposed Sec. 26.63(b) would permit licensees to rely
upon suitable inquiry information that was gathered by other licensees
and entities. However, for all applicants for authorization, the
suitable inquiry would be more thorough than previous industry
practices, in order to increase the likelihood that PDFFDI would be
identified, if it existed, and to provide reasonable assurance that
individuals are trustworthy and reliable as demonstrated by the
avoidance of substance abuse. For individuals who have established a
recent, favorable work history within the industry, as demonstrated by
having held authorization that was terminated favorably within the past
3 three years, the period of time addressed in the suitable inquiry
would be reduced from the past 5 five years in every case, to the past
3 three years or less, depending upon how recently the applicant held
authorization. If PDFFDI within the past 5 five years is identified
regarding an applicant and the information had not been addressed and
favorably resolved by a previous licensee or other entity, the suitable
inquiry requirements would be more extensive, as described in proposed
Sec. 26.69.
Industry Comment 13: Allow credit for prior licensee's medical
determination of fitness.
Response: The NRC has clarified the qualification requirements for
the medical personnel who may conduct a determination of fitness and
believe that these clarifications will provide greater consistency in
the determinations made across licensees. Therefore, a requirement for
each new licensee to perform another determination of fitness for
authorization reinstatements (authorization interrupted for 365 days or
less) and authorization updates
[[Page 50465]]
(authorization interrupted for >365 days to <3 years) when no new
PDFFDI has been identified would be unnecessary.
Industry Comment 14: Requirements for FFD should be consistent with
access authorization requirements.
Response: The provisions of the proposed rule are consistent with
current access authorization requirements, including those in the
recent access authorization Order, which the Commission issued to
nuclear power reactor licensees on January 7, 2003.
Industry Comment 15: Medical determination of fitness for all
individuals with a history of substance abuse creates an unnecessary
burden.
Response: The proposed rule would add Sec. 26.189(b)-(d) to
clarify the NRC's intent with regard to the circumstances in which a
determination of fitness is required. Permitting licensees to accept
the results of a determination of fitness conducted by a previous
licensee, when no new PDFFDI has been identified, reduces the
unnecessary burden that stakeholders referenced. However, a
determination of fitness would continue to be required before an
individual is granted authorization to perform activities within the
scope of this part when PDFFDI is identified and has not been
previously evaluated by another licensee.
Industry Comment 16: Rule does not allow shared audits of HHS-
certified laboratories.
Response: The NRC believes that a requirement for independent
audits by all licensees who rely on a laboratory is a redundant and
unnecessary requirement. The proposed rule would specify requirements
for sharing audits in proposed Sec. 26.41(g). This paragraph would
state that licensees may jointly conduct audits, or accept audits of C/
Vs and HHS-certified laboratories that were conducted by other
licensees or entities subject to this part, when the services provided
to the sharing licensees or entities by the C/Vs and HHS-certified
laboratories are the same. Nonetheless, each sharing licensee is
responsible for ensuring the correction of any deficiencies identified
in audit results.
B. Key Stakeholder Comments Not Incorporated Into Proposed Rule and
Responses
The headings below provide a listing of the significant comments
received, but not incorporated, for each subpart in the proposed rule.
The comments were received from stakeholders during development of this
proposed rule. Following each comment is a response detailing why the
comment was not incorporated into the proposed rule.
Subpart A Administrative Provisions
There are no significant comments that were not incorporated into
the proposed rule text.
Subpart B Program Elements
Comment 1 (NEI): The Medical Review Officer should not be included
in the random testing program.
Response: Although current Section 2.3 [Preventing subversion of
testing] in Appendix A to Part 26 requires licensees to carefully
select and monitor individuals who are responsible for administering
the drug and alcohol testing program based upon the highest standards
of honesty and integrity, some licensees' testing programs did not
include all of the FFD program personnel (including MROs) who the NRC
originally intended to be subject to testing. The proposed change would
be made to clarify the NRC's original intent because the actions of
these individuals have an ongoing effect on public health and safety as
a result of their responsibility to ensure that the FFD program is
effective. In addition, these persons' actions affect the confidence
that the public, management, and individuals who are subject to testing
have in the integrity of the program and the accuracy and reliability
of test results. Individuals who are involved in the day-to-day
operations of an FFD program are in a position to permit substance
abusers to remain undetected. For example, MROs could inadvertently
commit errors when reviewing test results as a result of being impaired
from drug or alcohol abuse or because of motives associated with
maintaining an MRO's substance abuse or empathy with an abuser.
Furthermore, several reported incidents have confirmed the need to
assure that FFD program personnel meet the highest standards of
honesty, integrity, reliability, and trustworthiness. For example, one
licensee added specimen collectors to the testing pool after
investigating an allegation and determining that two collectors were
substance abusers. In another instance, a contracted MRO who was not in
the testing pool was reported to be an alcoholic and an abuser of
prescription drugs. Some MROs who provided their services to other
Federally regulated industries were identified as substance abusers.
Therefore, the proposed rule provision would fulfill the NRC's original
objective and require licensees and other entities to extend their
programs to include FFD personnel who (1) can link test results with
the individual who was tested before an FFD policy violation
determination is made, including, but not limited to the MRO; (2) make
determinations of fitness; (3) make authorization decisions; (4) are
involved in selecting or notifying individuals for testing; or (5) are
involved in the collection or on-site testing of specimens.
Comment 2 (NEI): The FFD training requirements are too detailed,
particularly the requirement for the FFD exam to be a separate exam,
and for each knowledge and ability (KA) to be covered on each test.
Response: The proposed rule would require that individuals who are
subject to the FFD program demonstrate attainment of the specified KAs
by passing a comprehensive examination. This new requirement would be
added because there have been several instances since Part 26 was first
promulgated in which individuals were able to overturn determinations
that they had violated a licensee's FFD policy on the basis that they
had not understood the information they received during FFD training
and so could not be expected to comply with the requirements of the
policy. Therefore, the proposed rule would require individuals to
demonstrate their attainment of the knowledge and abilities to ensure
that the FFD training has been effective. There would also be a
requirement for the examination to include a comprehensive random
sampling of all KAs with questions to test each KA, including at least
one question for each KA, and establish a minimum passing score of 80
percent. These requirements would be modeled on other required training
programs that have been successful in ensuring that examinations are
valid and individuals have achieved an adequate understanding of the
subject matter.
Comment 3 (Quest Diagnostics): Unannounced audits of HHS
laboratories by the licensee, other entity, or NRC inspectors at any
time is unreasonable given the other inspections, client tours,
scheduled department meetings, and off-site requirements for testimony
that are required of laboratories and their staff. The audits should
also not be more than 48 hours in duration, and original documents or
copies should not be allowed to be removed from the laboratory.
Response: The proposed rule would permit audits to be unannounced
to enhance the effectiveness of the audit process should unannounced
audits appear to be necessary. For example, a licensee or other entity
may receive allegations that a laboratory is falsifying records or that
laboratory employees are using drugs, and the licensee or other
[[Page 50466]]
entity may determine that an unannounced audit would provide the most
effective means to investigate such allegations. The proposed rule
would ensure that the licensee's or other entity's contract with the
lab would permit the unannounced audit as well as access to any
information necessary to conduct the audit.
The NRC has also not proposed limits on the duration of such
audits, as time limits may decrease the effectiveness and integrity of
the audit process. Licensees or other entities may determine they
require more lengthy audits to effectively cover all intended areas, or
to assess deficiencies.
The NRC has incorporated a provision to permit an HHS-certified
laboratory to reasonably limit the use and dissemination of any
documents copied or taken away by the licensee's or other entity's
auditors in order to ensure the protection of proprietary information
and donors' privacy. However, the NRC does not believe auditors should
be restricted from copying or taking away documents that do not meet
the above criteria, because doing so would decrease the efficiency and
effectiveness of audits.
Subpart C Granting and Maintaining Authorization
Comment 1 (NEI): The process for granting authorization for
individuals whose prior authorization was terminated unfavorably should
be an initial.
Response: The proposed rule would require licensees to follow the
proposed provisions in Sec. 26.69 for individuals whose prior
authorization was terminated unfavorably due to an FFD concern.
Licensees would not be permitted to use the proposed process for
granting initial authorization for those individuals for several
reasons. First, if an individual was terminated for a first positive
drug or alcohol test result, and if it has been any period less than 3
years since that individual was terminated, then it would be
unnecessary to require licensees and other entities to perform a
suitable inquiry of the entire past 3 years (which would be required
for an initial authorization). In those cases, proposed Sec. 26.69
would require licensees or other entities to perform a suitable inquiry
for the period since the individual's authorization was terminated.
Second, if an individual has had his or her authorization denied for 5
years, the suitable inquiry should be performed for the entire past 5
years (as required in proposed Sec. 26.69). The proposed process for
granting initial authorization would only require a suitable inquiry
for the past 3 years, and the NRC believes that would not be
appropriate in these situations. If an individual's prior authorization
was terminated unfavorably for reasons that are unrelated to an FFD
concern, the licensee would implement the relevant requirements in the
access authorization Orders, which the Commission issued to nuclear
power reactor licensees on January 7, 2003.
Comment 2 (NEI): There should not be any additional drug and
alcohol testing for applicants for reinstatement of authorization whose
last period of authorization ended between 6 and 30 days ago.
Response: The proposed rule would require licensees and other
entities to subject applicants whose authorization has been interrupted
for 6-30 days to the possibility of being selected for pre-access
testing at a probability of approximately 4 percent. This probability
approximates the likelihood that individuals who are subject to random
testing at the 50 percent annual testing rate would be selected for
testing at some point within a 30-day period. For applicants selected
for such testing, the licensee or other entity would complete an
alcohol test and collect a specimen for drug testing before reinstating
the individual's authorization. The provision would enhance the
deterrent effect of pre-access testing for individuals who have had a
very short break in authorization, without imposing the regulatory
burden of requiring that every individual be tested.
This is one of many changes to Subpart C that are being proposed to
emphasize the NRC's intent that FFD programs provide reasonable
assurance that persons who are subject to this part are trustworthy and
reliable as demonstrated by the avoidance of substance abuse and the
adverse behaviors that accompany it. To reduce the risk of an insider
threat, maintain public health and safety, and provide for the common
defense and security in the post-September 11, 2001, threat
environment; the NRC has placed an increased emphasis on the
trustworthiness and reliability of individuals who have access to
certain types of sensitive information, certain types of radiological
materials, and protected areas in nuclear power plants--the same
individuals who would be subject to the proposed rule. Because these
individuals have unimpeded access to sensitive information and safety
equipment and systems, their trustworthiness and reliability are
essential. The NRC concludes that an increased level of requirements
are necessary for the new threat environment, such that there remains
reasonable assurance that individuals who are subject to the rule are
trustworthy and reliable. Pre-access testing is one important aspect of
FFD programs designed to deter and detect substance abuse, which
presents an unacceptable risk to public health and safety and the
common defense and security in several ways.
First, substance abuse increases the likelihood that such
individuals may pose an insider threat by increasing an individual's
vulnerability to coercion. Under 10 CFR 73.1, a passive insider is
defined as an individual who obtains or attempts to obtain safeguards
or other relevant information, such as a nuclear power plant's physical
configuration and design, and who does not have a functional or
operational need to know such information. Section 73.1 defines an
active insider as a knowledgeable individual who, while within the
protected area of a nuclear power plant in an unescorted status, takes
direct action to facilitate entrance and exit, disable alarms and
communications, and/or participates in a violent attack. An individual
who uses illegal drugs may be coerced into cooperating, actively or
passively, with a terrorist in an attempt to commit radiological
sabotage if, for example, the terrorist were to threaten the individual
with revealing his or her illegal drug use or was somehow able to
withhold drugs from an individual who is addicted.
Second, an individual's judgement and self-control are impaired
while an individual is abusing drugs or alcohol. When an individual is
intoxicated from abusing any of the substances for which testing is
conducted under Part 26, including alcohol, the individual is more
likely to inadvertently reveal sensitive information that terrorists
could use in a radiological sabotage attempt than when he or she is not
intoxicated.
Third, the use of illegal drugs establishes that an individual is
willing to disobey the law, thus indicating that the individual will
disregard other rules and regulations. The use of illegal drugs raises
questions about the individual's trustworthiness and reliability in
terms of scrupulously following the regulations, procedures, and other
requirements, such as safeguards requirements, that ensure the
protection of public health and safety.
Many provisions of the current rule provide means to identify and
reduce the risks posed by any individuals whose substance abuse casts
doubt on their trustworthiness and reliability. In combination with
other measures the
[[Page 50467]]
NRC has taken since September 11, 2001, the proposed requirement that
individuals who have had a break in authorization of between 6-30 days
must be subject to one-time selection for pre-access testing would
provide further assurance that those individuals are trustworthy and
reliable. The NRC believes that implementation of this provision and
other provisions in the proposed rule, in addition to the other,
related measures the Agency has taken in the post-September 11, 2001,
threat environment, would provide reasonable assurance that individuals
who are subject to the rule are trustworthy and reliable.
Subpart D Management Actions and Sanctions To Be Imposed
There are no significant comments that were not incorporated into
the proposed rule text.
Subpart E Collecting Specimens for Testing
There are no significant comments that were not incorporated into
the proposed rule text.
Subpart F Licensee Testing Facilities
Comment 1 (NEI): Significant QA requirements have been added, which
makes licensee testing facilities perform at the same level as an HHS-
certified laboratory. This will result in licensees closing many of
their licensee testing facilities.
Response: New requirements would be added for conducting initial
urine specimen validity tests at licensee testing facilities. Specimen
validity testing refers to testing conducted to identify attempts to
tamper with a specimen. This includes adulteration, which means putting
a substance into a specimen that is designed to mask or destroy the
drug or drug metabolite that the specimen may contain or to adversely
affect the assay reagent; substitution, which includes replacing a
valid urine specimen with a drug-free specimen; and dilution, which
includes intentionally diluting a urine specimen with another liquid to
decrease the concentration of a drug below the cutoff concentration.
When HHS published its Notice of Proposed Revisions (66 FR 43876;
August 21, 2001) to the HHS Guidelines to establish requirements for
specimen validity testing performed by HHS-certified laboratories, the
HHS reported that the number of adulterated and substituted urine
specimens has been increasing among the specimens tested under the
Federal agency workplace drug testing program and the U.S. Department
of Transportation (DOT) regulations (49 CFR part 40). Program
experience gained since Part 26 was first promulgated has also
indicated an increasing number of adulterated and substituted urine
specimens. Although current Part 26 contains a number of requirements
related to specimen validity, the methods available to tamper with
specimens have become more sophisticated since the rule was first
published and therefore more sophisticated methods of detecting
tampering are necessary. The proposed rule would incorporate new
requirements for conducting specimen validity tests that are consistent
with similar provisions contained in the most recent revision to the
HHS Guidelines (69 FR 19643; April 13, 2004). These new requirements
for specimen validity testing would be added to strengthen FFD programs
by improving the ability to detect specimens that are adulterated,
substituted, or diluted.
The requirements for specimen validity testing are proposed to
identify individuals who are willing to attempt to subvert the testing
process, and so may be willing to subvert other rules and regulations
that are important for public health and safety and the common defense
and security. Detecting specimen tampering is necessary to identify
individuals who may attempt to hide drug abuse, because attempts to
tamper with a specimen provide clear evidence that the individual is
not trustworthy and reliable.
The proposed rule would permit licensees to conduct drug and
validity screening tests, and to grant authorization to individuals
whose specimens yield negative test results. If the NRC were not to
include quality assurance and training requirements in conjunction with
such tests, but still permit licensees to grant authorization on the
basis of the tests, then the NRC would not have reasonable assurance
that only individuals who are trustworthy and reliable are granted
authorization. Therefore, the NRC has included such provisions in this
proposed rule.
Comment 2 (NEI): Licensees should be permitted 3 business days to
send Bottle B of a split specimen to the HHS lab for testing, following
a request from the donor.
Response: The proposed rule would extend the time period provided
to the licensee to send Bottle B to the HHS-certified laboratory. The
current rule requires that the specimen must be sent the same day as
the donor request. The proposed rule would allow 1 business day to send
the specimen. The proposed rule would not allow 3 days, as requested by
NEI, because the proposed rule would also require licensees to
administratively withdraw the individual's authorization at the time
Bottle A is confirmed non-negative. The NRC believes that permitting up
to 3 days would pose an unnecessary burden on the individual,
especially because some licensees temporarily remove pay until the
Bottle B test is complete. The NRC also believes that 1 business day
would provide sufficient time for the licensee to locate Bottle B,
prepare it for shipping, and deliver it to the courier.
Subpart G Laboratories Certified by the Department of Health and Human
Services
Comment 1 (Quest Diagnostics): If an individual who is the subject
of a drug test requests in writing to have access to the laboratory's
records related to his or her drug test, the records released should be
limited to the laboratory test report and data package, and not include
the results of any relevant certification, review, or revocation-of-
certification proceedings. Blanket releases by the employee to third
parties should be prohibited.
Response: The proposed rule would permit an individual to have
access to laboratory records, as well as a third party such as an
attorney to whom the employee has released the information. The records
that an employee may request include laboratory records beyond the
individual's drug test results because other records may be relevant to
litigation. For instance, if a laboratory audit subsequent to the
individual's test uncovers improper testing that may be relevant to the
individual's test, that information may be useful in litigation. The
NRC sees no justification for withholding such information from an
individual or an authorized third party, and believes access to such
information to be consistent with protection of the individual's rights
and with due process. The provision is also consistent with HHS
guidelines and Section 503 of Public Law 100-71 for Federal workplace
drug testing.
Comment 2 (Quest Diagnostics): Cutoff levels should be consistent
with new HHS proposed Guidelines.
Response: The NRC typically considers HHS provisions for inclusion
into a Part 26 proposed rule following the issuance of final HHS
Guidelines. This is to minimize the possibility that a Part 26 proposed
rule must be re-proposed due to changes in the HHS Guidelines between
their proposed and final forms, and to ensure proper stakeholder
interaction in the technical basis development stage, followed by
public review and comment of the Part 26 proposed provisions. The NRC
will consider the proposed HHS Guidelines
[[Page 50468]]
for inclusion into the technical basis development for a future Part 26
rulemaking once they have been finalized by HHS.
Subpart H Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Comment 1 (NEI): The MRO has too much independent responsibility,
given that the licensee is responsible for the program. The MRO is part
of the licensee program and should be accountable within the program,
not independent of the program.
Response: The proposed rule would require that MRO and MRO staff
duties must be independent from any other activity or interest of the
licensee or other entity. Although the NRC is unaware of any instances
in which the MRO function has been compromised in Part 26 programs, the
experience of other Federal agencies has indicated that clear limits on
independence and who may direct MRO staff activities are advisable.
Further, in contrast to other Federal agencies' regulations, current
Part 26 permits employees of licensees and other entities to perform
MRO staff activities for MROs who work off site and are not physically
present to supervise the staff, which may provide greater opportunities
for inadvertent compromise of the independence of the MRO function than
situations in which the MRO and his or her staff are physically co-
located. Independence of the MRO function from the licensee or other
entity is necessary to ensure that MROs are impartial gatekeepers for
the accuracy and integrity of the drug testing process and also to
ensure the confidentiality of medical information.
Comment 2 (NEI): The SAE requirements for qualification are
excessive.
Response: Detailed requirements regarding the qualifications and
responsibilities of the SAE are necessary to ensure consistency among
FFD programs. This is because under the proposed rule, FFD programs
would be permitted to accept determinations of fitness and treatment
plans from other Part 26 programs, if an individual who has had a
substance abuse problem will be granted authorization by another
licensee or entity. In addition, detailed requirements regarding the
qualifications and responsibilities of the SAE are necessary because of
the key role the SAE would play in assuring the public health and
safety and common defense and security when making a determination of
fitness. The SAE role is not defined in the current rule. Therefore,
many of the provisions in the proposed subpart would be adapted from
related DOT requirements regarding the ``substance abuse professional''
[49 CFR Part 40, Subpart O; 65 FR 41944; August 9, 2001]. Additionally,
the NRC has received feedback on implementation of the current rule
that some MROs do not feel qualified to make decisions on substance
abuse treatment and rehabilitation. Under the proposed rule, the
critical tasks of assessing the presence of a substance abuse disorder,
providing input to authorization decisions, and developing treatment
plans would be reserved for professionals who have met the specific
training, clinical experience, and knowledge requirements for an SAE.
Subpart I Managing Fatigue
Subpart I would establish clear and enforceable requirements
concerning the management of fatigue at nuclear power plants. Many
stakeholders took an interest in, and commented on Subpart I through
the public meetings, including IBEW, UCS, the Nuclear Energy Institute
(NEI), the Professional Reactor Operator Society (PROS), industry
representatives, and Barry Quigley, the petitioner, among others.
Because of the level of interest and commenting on Subpart I, in
comparison to the other subparts, several key comments that were not
incorporated, and their responses, are provided below for each of the
stakeholders listed above.
Comment 1 (IBEW): Individuals allowed to perform fatigue
assessments should be trained to a higher level than others.
Response: The NRC is proposing to train individuals and supervisors
to the same level because fatigue management is a shared
responsibility. The proposed level of training would provide the
knowledge needed to perform a fatigue assessment, including providing
an understanding of the indications and effects of fatigue, and the
appropriate use of fatigue countermeasures. This ensures that those
individuals who may undergo a fatigue assessment have been trained to
understand the process to which they will be subject and what the
assessor will be looking for, in addition to being able to recognize
the signs of fatigue in their coworkers. Because the training on what
to expect from a fatigue assessment is not substantially different from
how to conduct one, for simplicity of implementation, all workers would
be trained to the same level. In addition, the proposed revisions to
drug and alcohol testing provisions would revise that training such
that all workers are required to be trained to the same level. The
fatigue training would therefore be consistent with those provisions as
well.
Comment 2 (Patrick Shaffer, Southern California Edison): The 48
hour/week group average limit is not high enough for groups other than
security force personnel that would be subject to the proposed work
hour controls. A 60 hour/week group average limit would be preferable.
Response: Answered in the response to Comment 4, below.
Comment 3 (Barry Quigley, petitioner): The group average limit
should not be increased above a 48 hour/week limit.
Response: Answered in the response to Comment 4, below.
Comment 4 (UCS): The proposed rule would permit the entire affected
workforce to work 53-hour weeks [including shift turnover time], which
erodes fatigue protection from the 40-hour weeks recommended in NRC's
Policy on Worker Fatigue.
Response: The objectives of the 48-hour group limit during normal
plant operations are to ensure that the amount of overtime typically
worked by individuals does not adversely affect their abilities to
safely and competently perform their duties, to define an enforceable
upper limit to the nominal 40-hour work-week policy in GL 82-12, and to
permit licensees to manage overtime in a manner that reflects the
differing desires and capabilities of individuals with respect to work
hours. A more detailed discussion of the basis for requiring a 48 hour/
week group average limit is provided in Section VI with respect to
proposed Sec. 26.199(f), and is also summarized below.
A 40-hour work-week during normal operations is a key objective of
the NRC's Policy on Worker Fatigue. The policy is intended to ensure
that there are enough operating personnel to ``maintain adequate shift
coverage without routine heavy use of overtime.'' However, the policy,
and the 40-hour work-week objective, are not enforceable.
Routine overtime can cause cumulative fatigue, which degrades the
abilities of workers to safely and competently perform their duties.
The proposed collective work hour controls, including the 48-hour per
week group limit during normal plant operations, would address
cumulative fatigue by establishing more readily enforceable
requirements for the long-term control of work hours, including the
limited use of overtime for occasional short-term exigent circumstances
(e.g., equipment failure, personnel illness or attrition). The 48-hour
group limit would reduce the potential for cumulative fatigue by
[[Page 50469]]
preventing excessive use of the maximum allowable individual limits
during normal plant operations. The current regulatory framework does
not contain enforceable requirements to prevent such practices. In
addition, by limiting work hours during normal conditions, individuals
would be better rested and less susceptible to cumulative fatigue from
the long work hours that are common during plant and security system
outages. Further, it would provide reasonable assurance that
individuals will be better rested prior to an emergency or increased
threat condition.
The proposed requirement would limit groups of individuals to a 48-
hour average, permitting 20 percent overtime in excess of the nominal
40-hour work week. Consideration of several types and sources of
information led to the decision to establish a group average limit of
48 hours for normal plant conditions. These included past
recommendations from experts and expert panels on work scheduling and
maintaining worker alertness in the nuclear industry, surveys of
nuclear power plant workers on their desire and ability to work
overtime, data and industry practices on the amount of overtime worked
by security personnel, and requirements and practices in other
industries. A detailed description of the sources of information is
included in Section VI with respect to proposed Sec. 26.199(f).
Comment 5 (NEI): A 56-day outage exclusion from the 48-hour group
average work hour limits is insufficient.
Response: Answered in the response to Comment 7, below.
Comment 6 (UCS): The work hour limits should not be turned off
based on an unrelated artificial construct, such as outage duration(s)
and national security levels. Instead, the rule should state the work
hour limits for short and long terms.
Response: Answered in the response to Comment 7, below.
Comment 7 (Barry Quigley, petitioner): Outages should not be
excluded from the group work hour average limits.
Response: The collective work hour controls address the long-term
control of work hours, including the limited use of overtime for
occasional short-term exigent circumstances (e.g., equipment failure,
personnel illness or attrition). However, the NRC recognizes the need
to address separately the control of work hours during outages because
of the unique staffing and workload demands of this plant state.
Accordingly, the proposed rule would permit a limited exclusion period
for plant outages from the collective work hour controls.
The NRC considered several factors, including current policy, the
bases for the policy, and lessons learned from the policy
implementation in developing a provision to permit a limited exclusion
period for plant outages from the collective work hour controls. The
NRC's Policy on Worker Fatigue provides guidelines for controlling work
hours, ``on a temporary basis,'' during periods requiring substantial
overtime. The policy reflects the NRC's recognition that outages are
unique, relatively short-term, plant circumstances involving levels of
activity that are substantially higher than most non-outage operating
periods. The policy also reflects the NRC's understanding that although
individuals are capable of working with limited rest without
degradation of performance for short periods of time, research has
shown that the ability to sustain performance without adequate rest is
clearly limited. However, the NRC has never defined the term
``temporary basis'' as used in the policy. As a consequence, licensees
have used the guidelines to control working hours for conditions
ranging from a few days to more than a year. Industry experience with
conditions such as sustained plant shutdowns and the increased work
hours of security personnel following the terrorist attacks of
September 11, 2001, have indicated the need to establish clear and more
readily enforceable requirements that would limit the sustained use of
extended work hours.
The NRC considered several factors in setting the exclusion period
for plant outages at 8 weeks. First, by the end of 8 weeks of work at
the limits permitted, individuals will have worked 540 hours, including
200 hours of overtime. This is 50 percent of the hours that surveys of
nuclear plant workers have indicated are acceptable on an annual basis.
Second, by the end of 8 weeks of work at the limits permitted,
individuals will have missed as many as 17 normally scheduled days off,
a reduction of 60 percent in the time available to recover and prevent
cumulative fatigue. In addition, with each passing week of an outage,
individuals have worked an increasing number of normally scheduled days
off. The ability to defer daily living obligations becomes increasingly
difficult, causing increased pressure to reduce sleep time in order to
meet demands of both work and daily life, and increased potential for
cumulative fatigue.
In addition to considering the potential for cumulative fatigue,
the NRC considered current industry data concerning the duration of
plant outages. The average refueling outage duration, as indicated by
outage data from 2000-2002 in the Information System on Occupational
Exposure database (ADAMS Accession No. ML050190016), is approximately
39 days. Eighty-nine percent were less than 8 weeks in duration. In
reviewing the frequency of outages, by duration, the NRC found that it
would be necessary to increase the exclusion period substantially to
include a marginal number of additional outages. The NRC believes that
such an increase in the exclusion period would substantively increase
the potential for cumulative fatigue and fatigue-related personnel
errors. By contrast, decreasing the exclusion period to less than 8
weeks would rapidly increase the number of outages that would, in part,
be subject to the collective work hour controls, potentially increasing
the duration and cost of those outages. The NRC acknowledges that
decreasing the exclusion period by 1 or 2 weeks could decrease the
potential for cumulative fatigue, but the magnitude of the decrease
would be difficult to quantify and the benefit would not likely justify
the costs.
The NRC believes that an exclusion of the first 8 weeks of an
outage is consistent with the objective of ensuring that licensees
provide adequate shift coverage without routine heavy use of overtime.
The exclusion period would be limited to plant outages, which occur
regularly, but with limited frequency. In addition, the duration of the
exclusion period would be limited to 8 weeks, thereby providing
reasonable assurance that workers would be able to safely and
competently perform their duties, and not be impaired from cumulative
fatigue.
The NRC further considers that the exclusion of security system
outages and increased threat conditions is appropriate. In these
conditions, maintaining plant security is of the utmost importance. It
is specifically during these conditions that the NRC believes that the
benefits to the common defense and security of augmenting on-shift
security staffing during those conditions outweigh the potential risk
from increased fatigue for those time periods.
Comment 8 (PROS and UCS): Turnover time is excluded from the work
hour limit calculations, but there is no maximum allowed turnover time.
This could lead to excessive time allocated to turnovers, and therefore
hours worked.
[[Page 50470]]
Response: Although the NRC believes it is necessary and justified
to limit the number of hours worked by certain individuals to ensure
public health and safety and the common defense and security, the NRC
also believes shift turnovers contribute significantly to safety and
security. If the proposed rule included shift turnover in the work hour
calculations, licensees may have an incentive to limit turnover time,
which could have a negative impact on safety and security. The NRC
believes the importance of an accurate and thorough turnover should not
be undermined through the imposition of work hour restrictions related
to turnover.
The NRC shares the commenters' concern that excessive time
allocated to turnovers could result in excessive hours worked.
Therefore, proposed Sec. 26.199(b)(1)(I) would specify the types of
activities that would and would not be considered shift turnover
activities under the proposed rule. For example, the proposed paragraph
would define shift turnover activities as only those activities that
are necessary to safely transfer information and responsibilities
between two or more individuals between shifts. By contrast, the early
arrival of an individual for meetings, training, or pre-shift briefings
for special evolutions would not be considered shift turnover time. The
NRC believes that the proposed specifications for shift turnover
activities would be sufficient to ensure that excluding shift turnover
time from work hours calculations, combination with the other
requirements for fatigue management in the proposed rule, would be
sufficient to prevent individuals from working excessive hours.
Comment 9 (UCS): The formal determination that a waiver of the
individual work hour limits and break requirements ``is necessary to
mitigate or prevent a condition adverse to safety,'' or to ``maintain
the security of the facility,'' is hardly a robust barrier when one
considers all the safety-challenged things that have been changed at
nuclear power plants under the far more restrictive provisions of 10
CFR 50.59.
Response: The provisions of 10 CFR 50.59 do permit many minor
changes to be made at nuclear reactors because the safety criteria are
stated in the negative. In other words, a licensee is permitted to make
changes that do not have an adverse impact. In contrast, the proposed
waiver criteria would work in the positive. Minor safety issues would
not constitute a valid justification for a waiver of the individual
limits or break requirements because the criteria are stated in the
positive. Only work that ``is necessary to mitigate or prevent a
condition adverse to safety,'' or to ``maintain the security of the
facility,'' would meet the criteria. This is consistent with the NRC's
intent that waivers be approved only in very limited circumstances. The
NRC believes granting of waivers in these extreme cases is justified
and in the public interest because the gain in safety or security from
the work being completed in an unimpeded manner would offset the
potential reduction in safety or security from worker fatigue.
Comment 10 (NEI): Waivers should be allowed for pressing economic
concerns.
Response: The criteria for granting waivers from individual short-
term work hour limits and break requirements were strengthened from
current plant technical specification requirements to permit the
granting of waivers only for conditions adverse to safety or security.
Industry data have shown significant over-use of waivers, mostly for
commercial reasons, as is detailed in the Regulatory and Backfit
Analysis prepared for this proposed rule. The NRC believes the
individual short-term work hour limits and break requirements should
only be waived in unique circumstances, on a very infrequent basis, and
only when necessary for safety or security. Permitting waivers for
economic reasons would increase the potential risk to public health and
safety and the common defense and security from worker fatigue without
an off-setting gain to safety or security. As described in this section
with respect to the individual limits in proposed Sec. 26.199(d)(2)
and (3), the potential for worker fatigue in conditions that would
require a waiver is substantial (Baker, et al., 1994; Dawson and Reid,
1997; Stephens, 1995; Strohl, 1999). As a consequence, the NRC does not
believe that licensees can reasonably justify the performance of risk
significant functions at work hours in excess of the proposed limits on
the basis that the action would not constitute an adverse impact on
safety or security. During the public meetings described in Section V,
industry stakeholders proposed that a senior site manager have the
authority to grant waivers if the manager ``determines that the
deviation will not have an adverse impact on safety or security.'' The
NRC does not believe that the criterion proposed by industry
stakeholders is appropriate for several reasons. The work hour limits
of proposed Sec. 26.199(d) would apply only to personnel performing
risk significant functions. If an activity is not risk significant, it
is not subject to the work hour controls and therefore a waiver is
unnecessary. The proposed waiver criteria, therefore, do not impose
unnecessary restrictions in such circumstances. Further, the NRC does
not believe the proposed work hour limits and minimum break
requirements are unnecessarily conservative. The criterion proposed by
industry representatives is also highly subjective. In light of
concerns regarding industry's past use of deviations that the NRC
documented in SECY-01-0113, the use of a subjective criterion would not
be an effective regulatory approach to mitigating the past over-use of
waivers by certain licensees.
Comment 11 (NEI): There should not be a reporting requirement for
the number of waivers granted.
Response: As detailed in the Regulatory and Backfit Analysis, the
industry has, and continues to, grant excessive numbers of waivers each
year. Although the proposed provisions are expected to greatly limit
the number of waivers licensees can grant each year, the NRC believes
it is necessary and justified to monitor the number of waivers granted,
along with other indicators of FFD program performance that are
proposed to be monitored, to ensure the rule is implemented as intended
and that the fatigue portions of FFD programs are effective. The NRC
has weighed the burden introduced in the proposed reporting requirement
with the burden that would otherwise be required of NRC staff and
inspectors to perform such monitoring and has determined the burden is
justified. In that determination, the NRC has also considered that a
yearly FFD program performance report is currently required for the
drug and alcohol testing program, and the additional reporting for the
fatigue programs would merely add to the report, not create a new one.
Comment 12 (NEI): The fire brigade should not be subject to Subpart
I requirements.
Response: The proposed work hour limits would be applicable only to
those members of the fire brigade who are responsible for understanding
the effects of fire and fire suppressants on safe shutdown capability
for the reactor. This knowledge enables them to provide the control
room operators and fire brigade leader with information that is
critical to implementing a fire mitigation strategy that maintains safe
shutdown capability. For application of the collective work hour
controls specified in Sec. 26.199(f), these fire brigade members could
be averaged with another work group (e.g., operations) for those
individuals who perform the duties of both groups.
[[Page 50471]]
Attachment 1 to SECY-99-140, Recommendation for Reactor Fire Protection
Inspections, dated May 20, 1999, states that ``based on IPEEE results,
fire events are important contributors to the reported core damage
frequency (CDF) for a majority of plants. The reported CDF contribution
from fire events can, in some cases, approach (or even exceed) that
from internal events.'' Fire brigade members must retain the cognitive
ability to be able to think and determine the best way to suppress a
fire to prevent additional damage to safety-related equipment, evaluate
equipment affected by a fire to report to control room operators
concerning equipment availability, make decisions concerning smoke
ventilation to prevent the fire effects from affecting other plant
operations, and coordinate all activities with control room operators.
Fatigue can substantially degrade a worker's decision-making and
communication abilities, cause a worker to take more risks, and cause a
worker to maintain faulty diagnoses throughout an event, as detailed in
Section IV. D. These abilities are key to the duties of the fire
brigade members who are responsible for understanding the effects of
fire and fire suppressants on safe shutdown capability for the reactor.
Degradations of these abilities could have significant consequences on
the outcome of an event involving a fire. For instance, a fatigued
worker could incorrectly decide to vent smoke or toxic gas to an area
required for alternate shutdown, which could prevent or impair access
to equipment needed for safe shutdown of the plant. In addition, a
fatigued worker could incorrectly apply the wrong fire suppressant,
which could affect additional equipment in the plant. Further, impaired
decision-making could lead a worker to improperly control flooding,
which could impact other needed equipment, or could incorrectly
determine whether an area contains critical equipment and improperly
apply a suppressant in that area. Impaired communications could also
lead to incomplete disclosure of information to licensed operators in
the control room, which could adversely impact the decision-making of
those operators. If information known to the impaired worker is not
properly communicated, operators may not initiate appropriate actions
to mitigate the fire effects, or effects of suppressant activities, on
critical equipment. As a consequence, ensuring that the ability of fire
brigade members to safely and competently assess the effects of a fire
and fire suppressants on safe shutdown capability is essential to the
overall success of the fire mitigation strategy and the protection of
public health and safety.
Further, the NRC periodically grants exemptions from requirements
in 10 CFR Part 50, Appendix R [Fire Protection Program for Nuclear
Power Facilities Operating Prior to January 1, 1979] based on
protection of the levels of defense in depth listed in Section II(A) of
Appendix R to Part 50, which are ``To prevent fires from starting; To
detect rapidly, control, and extinguish promptly those fires that do
occur; To provide protection for structures, systems, and components
important to safety so that a fire that is not promptly extinguished by
the fire suppression activities will not prevent the safe shutdown of
the plant.'' Granting these exemptions is often predicated on effective
manual suppression of a fire by the fire brigade.
Comment 13 (NEI): There should not be requirements for a 48-hour
break every 14 days and a 24-hour break every 7 days.
Response: The NRC believes the proposed 24- and 48-hour break
requirements are necessary to reduce the effects of acute and
cumulative fatigue. A more detailed discussion of the basis for
requiring the 24- and 48-hour breaks is provided in Section VI with
respect to proposed Sec. 26.199(d)(2), and is also summarized below.
Acute fatigue results from excessive cognitive work and especially
from significant amounts of missed sleep. It is readily relieved by
obtaining adequate rest and sleep. Cumulative fatigue results from
individuals receiving inadequate sleep for successive days. As fatigue
increases, performance is increasingly impaired, shows greater
variability, and manifests itself in the form of errors of omission and
commission. Research has shown that lack of adequate days off and
extended workdays can result in cumulative sleep debt and performance
impairment. This research, as well as other considerations, is
discussed in detail in Section VI with respect to proposed Sec.
26.199(d)(2).
Additionally, the NRC considers the 24- and 48-hour breaks to be a
key component of fatigue mitigation for the transient workforce.
Contract and other temporary personnel move from one plant outage to
another within a region or nationally. During most portions of an
outage, these personnel would be subject only to the proposed
individual limits and break requirements. The break requirements, in
conjunction with the consideration that such temporary workers likely
have periodic seasonal breaks between outages, provides reasonable
assurance that they will not be impaired from either acute or
cumulative fatigue.
Comment 14 (PROS): Utilities should not be allowed to work licensed
operators up to 16 hours straight, they should be limited to 12 hours.
Response: Although proposed Subpart I would not prohibit the use of
16-hour shifts, the proposed rule includes requirements that
collectively address this concern. The proposed rule would include
controls that would reduce the frequency of 16-hour shifts. These
controls include proposed Sec. 26.199(d)(1)(ii), which would limit the
maximum hours worked in any 48-hour period to no more than 26 hours.
This limit prohibits individuals from working 16-hour shifts on two
consecutive days. Proposed Sec. 26.199(d)(2)(I) would require a
minimum 10-hour break between work periods and provide workers with the
opportunity for 7-8 hours of sleep. This requirement would create a
substantial disincentive for using 16-hour shifts. Specifically,
individuals who work 16-hour shifts would not be eligible to return to
work at the beginning of the next normally available shift.
The NRC acknowledges that 16-hour shifts can substantially increase
the probability for human error. Accordingly, the NRC believes that
fatigue management must include limiting the use of 16-hour shifts to
the extent practicable and applying effective behavioral observation
and fatigue mitigation strategies when such conditions are unavoidable.
The training requirements in the proposed rule would provide
individuals and supervisors with the knowledge to make effective
decisions regarding fatigue, which should result in the scheduling of
fewer 16-hour shifts. The proposed rule would also require licensees to
establish a process to be followed if an individual declares that he or
she is not fit for duty, for any reason, including fatigue. The NRC
would expect that individuals who believe that they are incapable of
safely and competently completing a 16-hour shift would make an
appropriate self-declaration.
Collectively, the requirements of the proposed rule would be
expected to: (1) Substantially limit the frequency of 16-hour shifts,
(2) provide assurance that, when such work hours are necessary,
licensees have the knowledge and abilities to assess the potential for
degraded performance and need for fatigue countermeasures, and (3)
ensure workers have a process for resolving concerns regarding fatigue
from extended work hours. As a
[[Page 50472]]
consequence, the NRC believes that the proposed requirements are
appropriate for maintaining worker fitness for duty and, thereby,
protecting public health and safety and the common defense and
security.
Comment 15 (Barry Quigley, petitioner): The work hour controls in
Subpart I should apply to all individuals performing risk-significant
work, such as engineers and all fire brigade personnel.
Response: The proposed requirements would cover all personnel who
perform duties within one of the following job duty groups: (1)
Operating or on-site directing of the operation of systems and
components that a risk-informed evaluation process has shown to be
significant to public health and safety; (2) performing maintenance or
on-site directing of the maintenance of structures, systems, and
components that a risk-informed evaluation process has shown to be
significant to public health and safety; (3) performing Health Physics
or Chemistry duties required as a member of the on-site emergency
response organization minimum shift complement; (4) performing the
duties of a Fire Brigade member who is responsible for understanding
the effects of fire and fire suppressants on safe shutdown capability;
and (5) performing security duties as an armed security force officer,
alarm station operator, response team leader, or watchperson
(hereinafter referred to as security personnel).
Engineers who direct, on-site, the maintenance or operations of
risk-significant structures, systems, and components would be subject
to group work hour controls. The NRC believes those engineers who
perform such duties should be subject to group work hour controls. A
few examples of such direction would be engineers who act as test
directors in the control room, engineers who provide direction to
maintenance crews (such as during an outage), engineers who provide
technical direction and guidance for reactivity manipulations and power
changes, as well as many other similar engineering functions. However,
the NRC does not believe that engineers, or other individuals, who do
not perform those duties should be subject to group work hour controls.
Many engineers do not direct maintenance or operations, and many others
do not work with risk-significant plant systems, structures, or
components. A few examples of engineering activities that the NRC does
not consider direction include design modifications, assisting in
procedure changes (including writing and modifying procedures for
covered work groups such as operations), performing technical analyses,
monitoring the performance of systems and recommend maintenance, as
well as many other similar engineering functions.
The NRC is not proposing to require licensees and other entities to
subject all engineers to work hour controls because many engineering
tasks, such as modification design, are reviewed by managers, peer
reviewers, and others before being implemented. The same is the case
for routine performance monitoring. Any maintenance recommended by an
engineer as a result of performance monitoring would typically be
reviewed by managers or work planners in maintenance. Therefore, the
NRC has reasonable assurance that errors committed by an engineer in
these circumstances would be found and corrected through the normal
plant review processes.
In the case of fire brigade personnel, the NRC is proposing that
only those fire brigade personnel who are responsible for understanding
the effects of fire and fire suppressants on safe shutdown capability
would be subject to work hour controls. The NRC does not propose to
include other members of the fire brigade because they are principally
engaged in manual actions. These types of actions do not require
substantial analysis and decision-making capability, and individuals
engaged in manual actions would be expected to perform those actions
without significant degradation from fatigue. Diagnosis and decision-
making functions are affected by fatigue to a much greater extent, and
are collectively more critical to emergency response. For these
reasons, the NRC proposes work hour controls on only the fire brigade
members who are responsible for understanding the effects of fire and
fire suppressants on safe shutdown capability.
Subpart J Recordkeeping and Reporting Requirements
There are no significant comments that were not incorporated into
the proposed rule text.
Subpart K Inspections, Violations, and Penalties
There are no significant comments that were not incorporated into
the proposed rule text.
VI. Section-by-Section Analysis of Substantive Changes
The proposed rule would be organized into eleven subparts that are
comprised of related requirements, as follows:
Subpart A--Administrative Provisions
Subpart B--Program Elements
Subpart C--Granting and Maintaining Authorization
Subpart D--Management Actions and Sanctions to be Imposed
Subpart E--Collecting Specimens for Testing
Subpart F--Licensee Testing Facilities
Subpart G--Laboratories Certified by the Department of Health and
Human Services
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Subpart I--Managing Fatigue
Subpart J--Recordkeeping and Reporting Requirements
Subpart K--Inspections, Violations, and Penalties
A detailed cross-reference table between the current and proposed
Part 26 provisions is included at the end of this notice.
Appendix A of the current rule would be deleted and the detailed
requirements for conducting drug and alcohol testing that are contained
in Appendix A to 10 CFR Part 26 would be moved to Subpart E [Collecting
Specimens for Testing], Subpart F [Licensee Testing Facilities], and
Subpart G [Laboratories Certified by the Department of Health and Human
Services] of the proposed rule.
Subpart A--Administrative Provisions
Section 26.1 Purpose
Section 26.1 [Purpose] of the proposed rule would amend the
language of the corresponding section of the current rule. The proposed
paragraph would delete the term, ``certain aspects,'' as unnecessary.
The proposed paragraph would add the term, ``implementation,'' to the
phrase in the current rule which states, ``for the establishment and
maintenance of * * * fitness-for-duty programs,'' in order to convey
more accurately that the proposed rule includes requirements for
implementing FFD programs, in addition to requirements for establishing
and maintaining such programs. The portion of current Sec. 26.1 that
refers to the entities who are subject to the rule would be moved to
proposed Sec. 26.3 [Scope] in order to consolidate this information in
a more appropriate location.
Section 26.3 Scope
Proposed Sec. 26.3 [Scope] would renumber, reorganize, and amend
current Sec. 26.2 [Scope]. In general, proposed Sec. 26.3 would
retain the list of entities who are subject to the current rule and add
other entities. However, the provisions in current Sec. 26.2 that
specify the individuals whose job duties require them to be subject to
the rule and exempt certain other individuals
[[Page 50473]]
would be moved to a new section, proposed Sec. 26.25 [Individuals
subject to the fitness-for-duty program]. The provisions that would be
moved to proposed Sec. 26.25 include the second sentence of current
Sec. 26.2(a), the first sentence of current Sec. 26.2(b), and the
portion of the second sentence of current Sec. 26.2(d) that pertains
to personnel. The NRC determined that separating into two different
sections the requirements that address the entities who are subject to
the rule and the requirements that address the individuals who must be
subject to the rule would make the two sets of provisions easier to
locate within the rule without compromising the intended meaning of
these provisions.
Proposed Sec. 26.3(a) would add combined operating license holders
to be consistent with the revised 10 CFR Part 52 licensing process for
new reactors.
Proposed Sec. 26.3(b) would retain the requirement in the first
sentence of current Sec. 26.2(a) that licensees who are authorized to
possess or use formula quantities of SSNM or to transport formula
quantities of SSNM are subject to the regulations in this part.
However, these licensees would not be subject to the requirements
contained in proposed Subpart I [Managing Fatigue] for the reasons that
will be discussed later in this document in relation to proposed Sec.
26.195 [Applicability].
Proposed Sec. 26.3(c) would retain the requirements of current
Sec. 26.2(d) and add references to entities other than a corporation
because there may be entities who are organized as firms, partnerships,
limited liability companies, or associations who may also obtain a
certificate or approved compliance plan under Part 76 and elect to
engage in activities involving formula quantities of SSNM. The proposed
paragraph would also add a cross-reference to proposed Sec.
26.25(a)(3), which specifies the individuals who are employed by or
under contract to these entities who would be subject to Part 26. The
entities in the proposed paragraph would not be subject to the
requirements in proposed Subpart I [Managing Fatigue] for the reasons
that will be discussed later in this document in relation to proposed
Sec. 26.195 [Applicability].
Proposed Sec. 26.3(d) would retain the meaning of the portion of
current Sec. 26.23(a)(1) that requires a contractor/vendor (C/V) FFD
program to meet the standards of this part if licensees rely upon the
C/V's FFD program to meet the requirements of this part, but amend some
of the terminology used in the current rule. The proposed paragraph
would add C/Vs to the list of entities who are subject to Part 26 in
proposed Sec. 26.3 in order to more clearly convey that C/Vs may be
directly subject to NRC inspection and enforcement actions than the
current rule language implies. The current rule text presents the
applicability of the rule's requirements to a C/V's FFD program in
terms of the contractual relationship between a licensee and the C/V.
For example, current Sec. 26.23(a)(1) states, ``The contractor or
vendor is responsible to the licensee [emphasis added] for adhering to
the licensee's fitness-for-duty policy, or maintaining and adhering to
an effective fitness-for-duty program; which meets the standards of
this part.'' This paragraph, and others in the current rule, could be
interpreted as implying that a C/V is accountable to the licensee but
not to the NRC, should significant weaknesses be identified in the C/
V's FFD program upon which a licensee relies. However, this
interpretation would be incorrect. Therefore, proposed Sec. 26.3(d)
would include C/V FFD programs and program elements upon which
licensees and other entities rely within this section to convey more
accurately that C/Vs are directly accountable for meeting the
applicable requirements of Part 26, rather than accountable only
through their contractual relationships with the licensees and other
entities who are subject to the rule. This clarification is also
necessary to maintain the internal consistency of the proposed rule
because some provisions of the proposed rule apply only to C/Vs,
including, but not limited to proposed Sec. 26.217(g).
The phrases, ``program elements'' and ``to the extent that
licensees and other entities rely upon those C/V FFD programs or
program elements to meet the requirements of this part,'' would be used
in proposed Sec. 26.3(d) because C/Vs would need only meet the
requirements of Part 26 for those FFD program elements upon which
licensees and other entities rely to meet the requirements of the rule.
For example, a C/V may choose to implement all of the program elements
that are required for a full FFD program under the proposed rule except
drug and alcohol testing. In this case, the proposed rule would not
require the C/V to address drug and alcohol testing in the C/V's FFD
policy, procedures, and training program; establish contracts with
drug-testing laboratories; collect specimens for drug and alcohol
testing; or meet any other requirements in the proposed rule that
relate to conducting drug and alcohol testing. However, if a C/V
chooses to conduct drug and alcohol testing under some or all of the
conditions specified in proposed Sec. 26.31(c) [Conditions for
testing], such as for-cause testing, and a licensee or other entity who
is subject to Part 26 relies upon the results of the C/V's tests in
determining whether to grant authorization to an individual (see
proposed Subpart C [Granting and Maintaining Authorization]), then the
use of these two phrases in the proposed paragraph would be correctly
interpreted as meaning that the C/V's drug and alcohol testing program
element must meet the proposed rule's requirements related to drug and
alcohol testing when conducting the tests on which the licensee or
other entity relies. By contrast, if a C/V implements an FFD program
element that is addressed in this part, but that program element is not
relied upon by a licensee or other entity who is subject to this part,
then the proposed paragraph would not require the C/V to meet the
applicable Part 26 requirements for that FFD program element.
Proposed Sec. 26.3(d) would require C/Vs to meet the requirements
of proposed Subpart I [Managing Fatigue], if any nuclear power plant
licensees rely upon a C/V's fatigue management program element to meet
the requirements of Subpart I. The applicability of proposed Subpart I
to C/Vs will be discussed with respect to proposed Sec. 26.195
[Applicability].
Other provisions of current Sec. 26.23 [Contractors and vendors]
would either be eliminated from the proposed rule or moved to other
sections of the proposed rule. The current requirement for licensees to
retain written agreements with C/Vs in the second sentence of Sec.
26.23 would be moved to proposed Subpart J [Recordkeeping and Reporting
Requirements]. The requirement in current Sec. 26.23(a)(1), which
requires that individuals who have violated an FFD program must not be
assigned to work within the scope of this part without the knowledge
and consent of the licensee, would be addressed in proposed Subpart C
[Granting and Maintaining Authorization]. The audit requirement
contained in current Sec. 26.23(b) would be addressed in proposed
Sec. 26.41(d) [Contracts]. The current requirements would be moved to
different sections of the proposed rule to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule, as discussed in Section IV. B, by grouping
related requirements together in one section or subpart that addresses
similar topics.
[[Page 50474]]
Proposed Sec. 26.3(e) would retain and update the requirements of
current Sec. 26.2(c) to be consistent with revisions to related
sections of the proposed rule as well as related parts of this chapter.
Combined operating license holders (under Part 52 of this chapter)
before the Commission has made the finding under Sec. 52.103 of this
chapter would continue to be subject to the rule, as well as combined
license applicants who have received authorization to construct under
Sec. 50.10(e)(3), construction permit holders (under Part 50 of this
chapter), construction permit applicants who have received
authorization to construct under Sec. 50.10(e)(3), and holders of
manufacturing licenses (under Part 52 of this chapter). For
consistency, the proposed paragraph would also replace the current
cross-references to other sections of the rule with updated cross-
references to the related sections in the proposed rule and replace
some terms used in the current paragraph with new terms that would be
used throughout the proposed rule. For example, the term, ``chemical
testing,'' would be replaced with ``drug and alcohol testing,'' and
``appeals'' would be replaced with ``review'' for reasons that will be
discussed below related to proposed Sec. 26.31 [Drug and alcohol
testing] and proposed Sec. 26.39 [Review process for fitness-for-duty
violations], respectively. Other new terms in the proposed rule that
would replace some of the terms used in the current rule are discussed
with respect to proposed Sec. 26.5 [Definitions].
Proposed Sec. 26.3(f) would retain the second sentence of current
Sec. 26.2(b) because it addresses entities who would not be subject to
the proposed rule. The first sentence of current Sec. 26.2(b), which
addresses individuals who are not subject to the rule, would be moved
to proposed Sec. 26.25 [Individuals subject to the fitness-for-duty
program] for organizational clarity in the proposed rule.
Section 26.5 Definitions
Proposed Sec. 26.5 [Definitions] would amend current Sec. 26.3
[Definitions] to (1) clarify some definitions; (2) make the listed
terms and their definitions more consistent with those used by other
Federal agencies (including the Substance Abuse and Mental Health
Services Administration and the Department of Transportation); (3)
define new terms used in other sections of the proposed rule; and (4)
move definitions into this section from current Section 1.2 of Appendix
A to 10 CFR Part 26, which contains definitions of important terms used
in Appendix A to Part 26. The proposed rule would also eliminate six
terms in current Sec. 26.3 and Section 1.2 of Appendix A to Part 26
because they would be fully defined in the text of the proposed rule or
would no longer be used in the proposed rule. In addition, the proposed
rule would eliminate redundant definitions of some terms, which appear
in both current Sec. 26.3 and Section 1.2 in Appendix A to Part 26.
Finally, some definitions would be revised to make them simpler and
easier to understand, consistent with the Agency's commitment to using
plain language. For example, some definitions in the current rule
include requirements that are also contained in other sections of the
rule. In these instances, the proposed rule would eliminate the
requirements that are embedded in the definitions, but retain the
definitions in this section. The requirements would be moved to the
related sections of the rule for organizational clarity.
The majority of the proposed changes to this section would be made
as a result of adding new requirements for urine drug testing,
including specimen validity testing, to the proposed rule. The proposed
rule would incorporate advances in the science and technology of urine
drug testing that are based on the most recent revision to the HHS
Guidelines, as published in the Federal Register on April 13, 2004 (69
FR 19643). These proposed changes would require adding terms to
proposed Sec. 26.5, modifying a number of the terms that are used in
the current rule, and revising the definitions of some terms in the
current rule that would also be used in the proposed rule, as follows:
The proposed rule would add several new terms to refer to urine
specimens that have characteristics that are inconsistent with those
expected of normal human urine, as identified through validity testing.
The proposed terms would include ``adulterated specimen,'' ``dilute
specimen,'' ``substituted specimen,'' and ``invalid result.'' The
proposed rule would also add the term, ``oxidizing adulterant,'' to
refer to one class of substances that may be used to adulterate urine
specimens. These new terms and proposed definitions would be adapted
from the HHS Guidelines.
The proposed rule also would add several terms that are associated
with new requirements for maintaining quality control of urine specimen
validity and drug testing, such as the term, ``quality control
sample.'' The proposed rule would also add definitions of the terms,
``calibrator,'' ``control,'' and ``standard,'' to distinguish among the
types of quality control samples that are associated with urine
specimen testing in Subparts F [Licensee Testing Facilities] and G
[Laboratories Certified by the Department of Health and Human Services]
of the proposed rule.
The proposed rule would change certain terms that describe drug and
alcohol tests to reflect the addition of urine specimen validity
testing requirements. The changes would include replacing the term,
``initial or screening test,'' with more specific terms to distinguish
between drug testing and testing for urine specimen validity. The
terms, ``validity screening test,'' ``initial drug test,'' and
``initial validity test,'' would be added to refer to the first tests
of a urine specimen that would be performed to determine whether a
urine specimen is free of drugs and drug metabolites and has the
expected characteristics of normal urine, or whether further testing of
the specimen is required. The proposed rule would also modify the
definition of ``initial drug test'' in the current rule to eliminate
the requirement that the test must be performed using immunoassay
techniques because that requirement would be addressed in the text of
the proposed rule. The proposed rule would replace the general term,
``confirmatory test,'' in the current rule with the more specific
terms, ``confirmatory drug or alcohol test'' and ``confirmatory
validity test.'' In addition, the definitions of these terms in the
proposed rule would not include requirements for the methods to be used
in performing confirmatory tests because these requirements would be
addressed in the text of the proposed rule. Therefore, the requirement
that confirmatory drug testing be performed using gas chromatography/
mass spectrometry (GC/MS) testing would be removed from the definition.
The proposed rule would also eliminate the reference to GC/MS testing
of blood samples for confirmatory alcohol testing in the definition of
``confirmatory drug or alcohol test'' because the proposed rule would
no longer give donors the option to provide a blood sample for alcohol
confirmatory testing, as discussed with respect to proposed Sec.
26.83(a).
The proposed rule would modify several terms that are used in the
current rule to describe the results of drug and alcohol testing, in
order to reduce the number of terms, increase consistency with terms
used by other Federal agencies, and address the addition of urine
specimen validity testing requirements. Among these changes, the
proposed rule would add the term ``non-negative test result.'' The
term, ``non-negative,'' would be used to refer to any adverse test
result from the different types of testing that would be
[[Page 50475]]
required under the proposed rule. For example, the proposed rule would
use ``non-negative'' to refer to positive results from alcohol testing
as well as results of drug and validity tests of urine specimens that
indicate the presence of drugs or drug metabolites, and/or that the
specimen may be adulterated, dilute, substituted, or invalid. The term,
``presumptive positive test result,'' would be eliminated from the
proposed section because it would no longer be used in the rule text.
The updated term, ``non-negative initial test result,'' would be used
in the rule text instead. The proposed rule would also change the term,
``confirmed positive test,'' to ``confirmed test result'' to clarify
that this term refers to the results of the MRO's review of drug and
validity tests of urine specimens and to positive results of a
confirmatory alcohol test, rather than to a type of testing. The
proposed rule would also remove the reference to testing of blood
specimens for alcohol that is contained in the current definition of
``confirmed positive test'' from the definition of ``confirmed test
result'' because blood specimens would no longer be collected at the
donor's request for confirmatory alcohol testing, as discussed with
respect to proposed Sec. 26.83(a).
The proposed rule would also add two terms that refer to testing
for very low levels of drugs, drug metabolites, or adulterants in a
urine specimen, ``limit of detection'' (LOD) and ``limit of
quantitation'' (LOQ). The proposed definitions of these terms would be
adapted from the HHS Guidelines.
In addition, the definitions of two terms in the current rule would
be modified to be consistent with the new drug and alcohol testing
terminology that would be used throughout the proposed rule. The
proposed rule would amend the definition of ``cutoff level'' to refer
to ``non-negative,'' rather than ``positive,'' test results to clarify
that the term is also applicable to the interpretation of results from
specimen validity testing. And, the definition of ``Medical Review
Officer'' (MRO) would be amended to refer to a ``non-negative'' test
result, rather than a ``positive'' test result, to clarify that the MRO
would review validity test results in addition to drug test results.
The proposed rule would also add several terms that would be
necessary to implement the proposed requirements contained in two new
subparts of the regulation, proposed Subpart C [Granting and
Maintaining Authorization] and proposed Subpart I [Managing Fatigue].
The proposed rule would add six new terms that are related to the
requirements of proposed Subpart C. The term, ``potentially
disqualifying fitness-for-duty (FFD) information,'' would be added to
refer to the types of information that licensees and other entities who
are subject to the rule would consider when deciding whether to grant
or maintain an individual's authorization to have the types of access
or perform the job duties that are listed in proposed Sec. 26.26(a).
The proposed rule would also add definitions for four terms that are
used within the definition of ``potentially disqualifying FFD
information,'' including ``substance abuse;'' ``legal action;''
``employment action;'' and ``reviewing official.'' The term, ``best
effort,'' would also be added to refer to the actions that a licensee
or other entity who is subject to the rule must take to obtain the
information that is necessary to complete a suitable inquiry and
employment history check, as discussed with respect to proposed Sec.
26.63(a).
The proposed rule would also add several terms that are necessary
to implement the requirements of proposed Subpart I [Managing Fatigue].
These terms would include ``fatigue,'' ``acute fatigue,'' and
``cumulative fatigue,'' which refer to the degradation in an
individual's cognitive (mental) and motor (physical) functioning
resulting from inadequate rest within the past 24 hours or over
successive days and weeks, respectively. The proposed rule would use
the term, ``alertness,'' to refer to an individual's ability to remain
awake and sustain attention, which is adversely affected by fatigue.
The term, ``circadian variation in alertness and performance,'' would
be added to define a factor that licensees would consider when
conducting a fatigue assessment under proposed Sec. 26.201 [Fatigue
assessments]. The proposed rule would also add the term, ``increase in
threat condition,'' to refer to circumstances in which the proposed
rule would provide licensees with some flexibility in implementing the
work hour controls of proposed Sec. 26.199 [Work hour controls].
The proposed rule would also add eight new terms related to other
proposed revisions to the current rule. Specifically, ``analytical
run'' would be added for use in establishing amended performance
testing requirements for licensee testing facilities in proposed Sec.
26.137 [Quality assurance and quality control]. The term,
``directing,'' would be added to clarify new requirements for MRO staff
under proposed Sec. 26.183(d) and the scope of individuals who would
be subject to work hour controls in proposed Sec. 26.199(a). For
consistency with the use of the term in the related regulations of
other Federal agencies, the term, ``donor,'' would replace the current
terms that are used to refer to an individual from whom a specimen is
collected for drug or alcohol testing. The term, ``nominal,'' would be
added to refer to the leeway in the time periods within which certain
requirements must be met, such as the requirement for annual FFD
refresher training in proposed Sec. 26.29(c)(2). The term, ``other
entity,'' would be added to refer to organizations who would be subject
to Part 26, but who are not licensed by the NRC, including, but not
limited to, the organizations who hold the NRC certificates or permits
listed in proposed Sec. 26.3 [Scope]. The terms, ``formula quantity''
and ``strategic special nuclear material'' (SSNM), would be defined
consistently with the definitions of the same terms in 10 CFR 70.4. The
term, ``subversion and subvert the testing process,'' would be added to
clarify the language of new provisions related to urine specimen
validity testing, as discussed with respect to proposed Sec.
26.31(d)(3)(i), and new sanctions that would be imposed on individuals
who are subject to the proposed rule, in proposed Sec. 26.75(b).
Proposed Sec. 26.5 would also retain and amend a number of other
definitions currently contained in Sec. 26.3 and Section 1.2 in
Appendix A to Part 26, as follows.
The proposed rule would revise the current definition of
``aliquot'' to clarify that an aliquot is a representative sample of a
urine specimen that may be used for testing. The amended definition
would be consistent with the same definition in the HHS Guidelines.
The proposed rule would simplify the current definition of ``blood
alcohol concentration'' (BAC) by deleting references to the instruments
and devices that licensees and other entities are permitted to use for
alcohol testing. The text of proposed Sec. 26.91 [Acceptable devices
for conducting initial and confirmatory tests for alcohol and methods
of use] would specify acceptable devices for alcohol testing under the
proposed rule.
The proposed rule would revise the definition of ``category IA
material'' to conform with the current definition contained in 10 CFR
74.4.
The proposed rule would expand the definition of ``chain of
custody'' to indicate that the terms ``chain of custody'' and ``custody
and control'' are synonymous. This proposed change would be made in
response to stakeholder requests during the public meetings discussed
in Section V.
The definition of ``collection site'' would be modified to include
a reference to oral fluids as specimens
[[Page 50476]]
that are acceptable for initial alcohol testing. The basis for
permitting the use of oral fluids for initial alcohol testing is
discussed with respect to proposed Sec. 26.83(a).
The proposed rule would replace the term, ``collection site
person,'' with the term, ``collector,'' to simplify the terminology
used to refer to individuals who collect specimens for testing and for
consistency with the terminology used by other Federal agencies. In
addition, the definition would no longer include the qualifications
required for collectors because they would be specified in proposed
Sec. 26.85 [Collector qualifications and responsibilities].
The proposed rule would add the term ``contractor/vendor'' (C/V)
and combine the definitions of ``contractor'' and ``vendor'' in the
current rule, because the proposed rule would not distinguish between
the two types of entities.
The proposed rule would update the definition of ``HHS-certified
laboratory'' to reference the most recent version of the HHS Mandatory
Guidelines for Federal Workplace Drug Testing Programs.
In addition, the proposed rule would simplify the definition of
``licensee testing facility'' by eliminating the reference to
collecting specimens for alcohol testing in the current definition,
because alcohol testing typically occurs at a collection site, rather
than at the licensee testing facility.
Finally, the proposed rule would eliminate six terms that are
defined in current Sec. 26.3 and Section 1.2 in Appendix A to Part 26.
Specifically, the proposed rule would eliminate ``followup testing,''
``random test,'' ``suitable inquiry,'' ``reason to believe,'' and
``split specimen'' because the text of the proposed rule defines them
in the section where each term is used. The proposed rule would also
eliminate the term, ``permanent record book,'' in current Section 1.2
in Appendix A to Part 26 because laboratories now use other mechanisms
to maintain testing records. Therefore, this term would no longer be
used in the proposed rule.
Section 26.7 Interpretations
Proposed Sec. 26.7 [Interpretations] would retain current Sec.
26.4 [Interpretations] but move the qualifying phrase, ``other than a
written interpretation by the General Counsel,'' to the end of the
sentence to improve the clarity of the sentence. This proposed change
would be made in keeping with the Commission's commitment to using
plain language in its regulations and to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule, as discussed in Section IV. B.
Section 26.8 Information Collection Requirements: OMB Approval
Proposed Sec. 26.8 [Information collection requirements: OMB
approval] would amend current Sec. 26.8 [Information collection
requirements: OMB approval] to reflect the modified sections of the
proposed rule in which recordkeeping requirements would be
incorporated.
Section 26.9 Specific Exemptions
Proposed Sec. 26.9 [Specific Exemptions] would revise current
Sec. 26.6 [Exemptions] to include the citation of 10 CFR 50.12 and
70.17. This proposed change would be made to ensure consistency between
Part 26 and these related requirements.
Section 26.11 Communications
Proposed Sec. 26.11 [Communications] would be added to improve
consistency with similar sections in other parts of 10 CFR and ensure
that communications with the NRC are addressed and, therefore,
processed properly.
Subpart B--Program Elements
Section 26.21 Fitness-for-Duty Program
Proposed Sec. 26.21 [Fitness-for-duty program] would require that
licensees and other entities who are subject to the rule must
establish, implement, and maintain FFD programs that comply with the
applicable requirements of this part. This statement would be added to
serve as an introduction to the remaining text of the proposed rule,
consistent with Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule, as discussed in Section
IV. B. The term, ``applicable,'' would be included in this sentence
because not all the requirements in the proposed regulation would apply
to all the entities listed in proposed Sec. 26.3(a)-(d). For example,
the requirements in proposed Subpart I [Managing Fatigue] would apply
only to nuclear power plant licensees and any C/Vs upon whom they rely
to meet the requirements of this part, as discussed with respect to
proposed Sec. 26.195 [Applicability]. As another example, the proposed
rule would retain the current requirement in Sec. 26.2(c), which
states that nuclear power plant construction permit holders must
establish a drug and alcohol testing program that includes random
testing, but would not require these entities to meet the requirements
of the proposed regulation related to drug and alcohol testing,
including, but not limited to, proposed Sec. 26.31 [Drug and alcohol
testing] and proposed Subpart E [Collecting Specimens for Testing].
The second sentence of the proposed paragraph, which is based on
current Sec. 26.23(b), would retain permission for licensees and other
entities to rely upon a C/V's FFD program or program elements to meet
the requirements of this part, if the C/V's FFD program or program
element meets the applicable requirements of this part. The other
requirements contained in current Sec. 26.23 [Contractors and vendors]
are discussed with respect to proposed Sec. 26.23 [Performance
objectives].
Section 26.23 Performance Objectives
Proposed Sec. 26.23 [Performance objectives] would amend current
Sec. 26.10 [General performance objectives], as follows:
The proposed rule would amend current Sec. 26.10(a). The proposed
rule would divide the performance objectives contained in current Sec.
26.10(a) into two paragraphs (proposed Sec. 26.23(a) and (b),
respectively) to clarify that the performance objective of assuring
that personnel are trustworthy and reliable is separate and distinct
from the performance objective of assuring that personnel are fit for
duty.
Proposed Sec. 26.23(a) would require that FFD programs provide
reasonable assurance that persons who are subject to this part are
trustworthy and reliable as demonstrated by the avoidance of substance
abuse and the adverse behaviors that accompany it. The NRC has placed
an increased emphasis on the trustworthiness and reliability of
individuals who have access to certain types of sensitive information,
certain types of radiological materials, and protected areas in nuclear
power plants since September 11, 2001. This level of emphasis is to
reduce the risk of an insider threat, maintain public health and
safety, and provide for the common defense and security in the post-
September 11, 2001, threat environment. These are the same individuals
who would be subject to the proposed rule. Because these individuals
have unimpeded access to sensitive information and safety equipment and
systems, their trustworthiness and reliability are essential. Substance
abuse by such individuals presents an unacceptable risk to public
health and safety and the common defense and security in several ways.
First, substance abuse increases the likelihood that such
individuals may pose an insider threat by increasing an individual's
vulnerability to coercion.
[[Page 50477]]
Under 10 CFR 73.1, a passive insider is defined as an individual who
obtains or attempts to obtain safeguards or other relevant information,
such as a nuclear power plant's physical configuration and design, and
who does not have a functional or operational need to know such
information. Section 73.1 defines an active insider as a knowledgeable
individual who, while within the protected area of a nuclear power
plant in an unescorted status, takes direct action to facilitate
entrance and exit, disable alarms and communications, and/or
participates in a violent attack. An individual who uses illegal drugs
may be coerced into cooperating, actively or passively, with a
terrorist in an attempt to commit radiological sabotage if, for
example, the terrorist were to threaten the individual with revealing
his or her illegal drug use or was somehow able to withhold drugs from
an individual who is addicted.
Second, an individual's judgement and self-control are impaired
while an individual is abusing drugs or alcohol. When an individual is
intoxicated from abusing any of the substances for which testing is
conducted under Part 26, including alcohol, the individual is more
likely to inadvertently reveal sensitive information that terrorists
could use in a radiological sabotage attempt than when he or she is not
intoxicated.
Third, the use of illegal drugs establishes that an individual is
willing to disobey the law, thus indicating that the individual will
disregard other rules and regulations. The use of illegal drugs raises
questions about the individual's trustworthiness and reliability in
terms of scrupulously following the regulations, procedures, and other
requirements, such as safeguards requirements, that ensure the
protection of public health and safety.
Many provisions of the current rule provide means to identify and
reduce the risks posed by any individuals whose substance abuse casts
doubt on their trustworthiness and reliability. In combination with
other measures the NRC has taken since September 11, 2001, a number of
the proposed changes to the current rule would provide further
assurance that individuals who are subject to the rule are trustworthy
and reliable. Proposed changes to strengthen the effectiveness of the
rule in assuring individuals' trustworthiness and reliability include,
but are not limited to:
(1) Adding requirements for specimen validity testing to identify
individuals who are willing to attempt to subvert the testing process,
and so may be willing to subvert other rules and regulations that are
important for public health and safety and the common defense and
security;
(2) Increasing the rigor of the evaluations that licensees and
other entities must perform before granting authorization to an
individual who has previously violated Part 26 requirements to ensure
that the individual has ceased abusing drugs or alcohol; and
(3) Imposing more stringent sanctions on individuals who violate
Part 26 requirements, including, but not limited to, permanently
denying authorization to have the types of access and perform the job
duties listed in proposed Sec. 26.25(a) to any individual who attempts
to subvert the drug and alcohol testing process.
The NRC believes that implementation of these provisions of the
proposed rule, in addition to the other, related measures the Agency
has taken in the post-September 11, 2001, threat environment, provides
an increased level of requirements appropriate for the new threat
environment, such that there remains reasonable assurance that
individuals who are subject to the rule are trustworthy and reliable.
Proposed Sec. 26.23(b) would retain the performance objective of
providing reasonable assurance that personnel are fit for duty, which
appears in current Sec. 26.10(a). The use of the term, ``reasonable,''
to describe the level of assurance required by the rule reflects the
NRC's awareness that an individual's fitness at any particular moment
in time may be affected by many different factors. Some of these
factors may be difficult for the licensee or other entity to detect and
many (such as a transitory illness) may not warrant management action
or the imposition of sanctions because they would not pose a
significant risk to public health and safety.
As mentioned above, the level of requirements associated with
achieving reasonable assurance of trustworthiness and reliability is
greater than that associated with reasonable assurance that individuals
are not impaired. Another example of this is with regard to the
sanctions that the proposed rule would require licensees and other
entities to impose on individuals who demonstrate questionable
trustworthiness and reliability compared to the management actions
licensees would be expected to take with individuals who may be
impaired. For example, if an individual demonstrates dishonesty by
attempting to bring a substitute urine specimen to the collection site
with a clear intent to subvert the testing process or demonstrates a
willingness to break the law by possessing illegal drugs on site, the
proposed rule (under proposed Sec. Sec. 26.75(b) and 26.75(c),
respectively) would require the licensee or other entity to terminate
the individual's authorization to have the types of access and perform
the job duties that are listed in proposed Sec. 26.25 [Individuals
subject to the fitness-for-duty program]. Terminating the individual's
authorization would be necessary to provide reasonable assurance that
the individual could pose no further risk to public health and safety
or the common defense and security. By contrast, the current and
proposed rules would not require a licensee or other entity to
terminate an individual's authorization if he or she is mentally or
physically impaired while on duty from such transitory causes as
illness and emotional stress resulting from a family problem. For
example, an individual who arrives at work with a severe migraine
headache may suffer impairment on the job that would adversely affect
the individual's ability to perform his or her duties safely and
competently while the headache persists. The proposed (and current)
rule (under proposed Sec. 26.77(b)(3) and current Sec. 26.27(b)(1),
respectively) would require the licensee or other entity to take action
to prevent the individual from performing the job duties that require
the individual to be subject to this part, if the individual's fitness
is questionable. These actions could include, for example, assigning
the individual to other duties until medication brings the headache
under control or sending the individual home until the headache
resolves. Such actions would meet the performance objective of
providing reasonable assurance that the individual is fit when he or
she resumes his or her normal duties. However, it would be unreasonable
for a licensee's FFD policy to impose sanctions on the individual, such
as terminating his or her authorization. Sanctions could have no
deterrent effect on the recurrence of the individual's headache, which
is one purpose of including requirements for minimum sanctions in Part
26. In addition, there would not be any continuing risk to public
health and safety from permitting the individual to resume his or her
duties once the headache is resolved.
Another difference between the performance objectives of providing
``reasonable'' assurance of trustworthiness and reliability and
``reasonable'' assurance that the
[[Page 50478]]
individuals who are subject to the proposed rule are fit for duty lies
in the severity of the enforcement actions that the NRC would be likely
to take against an FFD program that failed to meet these performance
objectives. The NRC's enforcement actions would be severe in the case
of an FFD program that, for example, granted authorization to an
individual who had previously had his or her authorization permanently
denied under proposed Sec. 26.75(b) but would be unlikely to take
enforcement action in the case of an FFD program that failed to remove
an individual who was experiencing impairment related to family stress
from his or her duties under proposed Sec. 26.77(b)(3).
Proposed Sec. 26.23(c) would retain the performance objective in
current Sec. 26.10(b), which is to ``provide reasonable measures for
the early detection of persons who are not fit to perform activities
within the scope of this part,'' but would replace the phrase,
``perform activities within the scope of this part,'' with the phrase,
``perform the job duties that require them to be subject to this
part.'' The proposed rule would make this change for clarity in the
language of the rule. As discussed further with respect to proposed
Sec. 26.25 [Individuals subject to the fitness-for-duty program], the
proposed rule would require that certain individuals must be subject to
an FFD program based on their job duties, which include not only
performing activities, such as measuring, guarding, or transporting
Category IA material, but also having access to certain locations,
material, and sensitive information, such as nuclear power plant
protected areas, Category IA material, procedures and records for
safeguarding SSNM, and the drug test results of an individual who was
tested before the MRO reviews the drug test results. Therefore, the
phrase, ``perform the job duties that require them to be subject to
this part,'' would be more accurate. Replacing the current phrase with
the more accurate phrase would be consistent with Goal 6 of the
rulemaking, which is to improve clarity in the organization and
language of the rule, as discussed in Section IV. B.
Proposed Sec. 26.23(d) would amend current Sec. 26.10(c) to
require that FFD programs must provide reasonable assurance that the
workplaces that are subject to this part are free from the presence and
effects of illegal drugs and alcohol. The proposed rule would revise
the current performance objective to ``have a goal of achieving a drug-
free workplace and a workplace free of the effects of such substances'
for several reasons. First, the terms, ``drug-free'' and ``free from
the effects of such substances,'' do not accurately capture the NRC's
intent with respect to this performance objective. These terms could be
misunderstood as requiring FFD programs to have the goal of preventing
any drugs and their effects from being present in the workplace, which
could include medications that individuals who are subject to the rule
may take to treat health problems. Therefore, the proposed rule would
replace ``drug-free'' and ``free of the effects of such substances''
with the more specific phrase, ``free from the presence and effects of
illegal drugs and alcohol'' to refer to the specific substances that
would be proscribed. The proposed revision would clarify that the NRC
does not intend for FFD programs to prohibit individuals from taking
the medications they need to maintain their health or bringing those
medications to the workplace. This proposed change would be made to
meet Goal 6 of the rulemaking, which is to improve clarity in the
organization and language of the rule.
The proposed performance objective would also replace the phrase,
``have a goal of,'' in the current rule with the phrase, ``provide
reasonable assurance,'' which more accurately captures the intent of
this performance objective. The phrase, ``have a goal of,'' would be
eliminated because proposed Sec. 26.23(d) is a performance objective
and, therefore, the phrase is unnecessary. This proposed change would
be made to meet Goal 6 of the rulemaking, which is to improve clarity
in the organization and language of the rule, without changing the
intended meaning of the performance objective.
Proposed Sec. 26.23(e) would be added to require licensees and
other entities to provide reasonable assurance that the effects of
fatigue and degraded alertness on individuals' abilities to safely and
competently perform their duties are managed commensurate with
maintaining public health and safety. This proposed performance
objective would be added to specify the objective of the requirements
concerning worker fatigue that would be added to the proposed rule.
Worker fatigue cannot be measured or controlled with precision, and
licensees and other entities do not have direct control over all
matters that may influence worker fatigue. Therefore, proposed Sec.
26.23(e) would establish a ``reasonable assurance'' criterion for the
proposed performance objective. Worker fatigue can result from many
causes (e.g., work hours, sleep disorders, demands outside the
workplace). In addition, individuals differ in their responses to
conditions that cause fatigue. As a consequence, work hour limits alone
do not address all causes of fatigue, nor do they prevent fatigue from
work hours for all workers. Contemporary methods for addressing worker
fatigue (e.g. Rogers, 1996, 1997; Hartley, 1998; Carroll, 1999) are
commonly referred to as ``fatigue management'' programs and use diverse
methods (e.g., training, behavioral observation, fatigue
countermeasures) in addition to work hour controls to prevent, detect,
and mitigate fatigue. Accordingly, proposed Sec. 26.23(e) would
establish a performance objective of reasonable assurance that effects
of fatigue and degraded alertness on individuals' abilities to safely
and competently perform their duties are ``managed'' commensurate with
maintaining public health and safety. The proposed performance
objective would permit licensees and other entities to apply risk-
informed fatigue management controls for individuals consistent with
the significance of their work activities to the protection of public
health and safety.
Section 26.25 Individuals Subject to the Fitness-for-Duty Program
Proposed Sec. 26.25 [Individuals subject to the fitness-for-duty
program] would be added to group together in one section the provisions
of the proposed rule that specify the individuals who must be subject
to the FFD program, based on their job duties, and those who would not
be subject to the FFD program. This proposed change would be made to
meet Goal 6 of the rulemaking, which is to improve clarity in the
organization and language of the rule, by grouping related requirements
together within the rule.
Proposed Sec. 26.25(a)(1)-(a)(3) would amend the portions of
current Sec. 26.2(a) and (d) that describe the individuals whose job
duties require them to be subject to Part 26 by presenting the
requirements in separate paragraphs. This organizational change would
be made to make it easier for users to locate these requirements within
the rule text and to support cross-referencing to these paragraphs from
other portions of the rule, so that it is unnecessary to repeat the
relevant list of job duties each time the rule refers to a specific
group of individuals, as the organization of the current rule has
required [see, for example, current Sec. 26.27(a)(1), (b)(2), and
(b)(3)]. This proposed change would be made to meet Goal 6 of the
rulemaking, which is to improve clarity in the organization and
language of the rule, as discussed in Section IV. B.
The proposed rule would add Sec. 26.25(a)(4) to clarify the NRC's
original
[[Page 50479]]
intent that FFD program personnel must be subject to the FFD program.
Although current Section 2.3 in Appendix A to Part 26 requires
licensees to carefully select and monitor individuals who are
responsible for administering the drug and alcohol testing program
based upon the highest standards of honesty and integrity, some
licensees' testing programs did not include all of the FFD program
personnel who the NRC originally intended to be subject to testing. The
proposed change would be made to clarify the NRC's original intent
because the actions of these individuals have an ongoing effect on
public health and safety and the common defense and security as a
result of their responsibility to ensure that FFD programs are
effective. In addition, these individuals' actions affect the
confidence that the public, management, and individuals who are subject
to testing have in the integrity of the program and the accuracy and
reliability of test results. Individuals who are involved in the day-
to-day operations of an FFD program are in a position to permit
substance abusers to remain undetected. For example, specimen
collectors could inadvertently commit errors when testing others as a
result of being impaired from drug or alcohol abuse or intentionally
omit testing an individual because of motives associated with
maintaining a collector's substance abuse or empathy with an abuser.
Furthermore, several reported incidents have confirmed the need to
assure that FFD program personnel meet the highest standards of
honesty, integrity, reliability, and trustworthiness. For example, one
licensee added specimen collectors to the testing pool after
investigating an allegation and determining that two collectors were
substance abusers. In another instance, a contracted MRO who was not in
the testing pool was reported to be an alcoholic and an abuser of
prescription drugs. Some MROs who provide their services to other
Federally regulated industries have also been identified as substance
abusers. Therefore, the proposed revision to current Sec. 26.2(a)
would fulfill the NRC's original objective and require licensees and
other entities to extend their programs to include FFD personnel who
(1) can link test results with the individual who was tested before an
FFD policy violation determination is made, including, but not limited
to the MRO; (2) make determinations of fitness; (3) make authorization
decisions; (4) are involved in selecting or notifying individuals for
testing; or (5) are involved in the collection or on-site testing of
specimens. Although job titles and responsibilities may differ among
different Part 26 FFD programs, examples of FFD program personnel who
would be subject to Part 26 under the proposed rule would include, but
would not be limited to, the following: The FFD program manager under
proposed Sec. 26.25(a)(4)(i)-(a)(4)(v); the MRO and MRO staff under
proposed Sec. 26.25(a)(4)(i); the licensee's or other entity's
reviewing officials under proposed Sec. 26.25(a)(4)(iii); specimen
collectors under proposed Sec. 26.25(a)(4)(v); SAEs who are under
contract to or employed by the FFD program under proposed Sec.
26.25(a)(4)(ii); and licensee testing facility personnel under proposed
Sec. 26.25(a)(4)(v). In some cases, information technology personnel
who design and implement software programs for selecting individuals
for random testing may also be subject to the rule under proposed Sec.
26.25(a)(4)(iv) if such personnel have knowledge of who will be
selected for random testing or the ability to affect the selection of
specific individuals for random testing.
Proposed Sec. 26.25(b)(1)-(b)(3) would be added to group together
in one paragraph the proposed rule's provisions that identify
individuals who would not be subject to the rule. This proposed change
would be made to meet Goal 6 of the rulemaking, which is to improve
clarity in the organization and language of the rule.
A new provision, proposed Sec. 26.25(b)(1), would be added to the
rule as a result of extensive discussions with industry stakeholders at
the public meetings mentioned in Section V. Industry stakeholders
expressed strong concern that the related language in the Affirmed Rule
(which was also discussed in Section V), which delineated the FFD
program personnel who must be subject to the Part 26, was too broad.
Stakeholders agreed that FFD program personnel who work on site and are
involved in the day-to-day operations of the FFD program should be
subject to the rule. However, the stakeholders noted that the language
used in the Affirmed Rule was so vague that it could be interpreted as
requiring, for example, that off-site human resources staff at a
licensee's or other entity's corporate offices, who may have access to
some FFD information about individuals, must be covered, as well as any
medical or treatment personnel, and their managers, at a hospital or
substance abuse treatment facility who provide an occasional FFD
program service. These interpretations of the intent of the Affirmed
Rule provisions would be incorrect.
The stakeholders also strongly disagreed with the requirement in
the Affirmed Rule that some FFD program personnel who maintain offices
at other locations than a licensee's or other entity's facilities and
are not involved in day-to-day program operations, such as EAP
counselors and some contract MROs, should be subject to the rule. The
stakeholders indicated that they believe the honesty and integrity of
such off-site personnel is maintained through their professions'
oversight and standards, with the result that requiring these
individuals to be subject to the rule would create a significant and
unnecessary regulatory burden. Stakeholders stated that the regulatory
burden would result from (1) the significant logistical difficulties
involved in ensuring that these individuals are subject to behavioral
observation and drug and alcohol testing, and (2) excessive costs to
hire additional MRO(s) to review any non-negative drug test results
from MRO(s) who serve the FFD program.
Based on the stakeholders' input, ``lessons learned'' from FFD
program experience since the rule was first implemented, the experience
gained by other Federal agencies and their regulated industries, and
the continuing need to ensure that FFD program personnel meet the
highest standards of honesty and integrity, the NRC added Sec.
26.25(b)(1) to the proposed rule. The proposed paragraph would exclude
from the rule individuals who may be called upon to provide an FFD
program service to a licensee or other entity in special circumstances
and who meet all of the following criteria:
(1) They are not employed by the licensee or other entity;
(2) They do not routinely provide services to the licensee's or
other entity's FFD program; and
(3) They do not normally work at a licensee's or other entity's
facility.
Examples of individuals who would not be subject to the rule under
the proposed provision may include, but would not be limited to, a
nurse at a local hospital who collects a single specimen for a post-
event test from an individual who has been injured and a counselor at a
residential substance abuse treatment facility who performs behavioral
observation of a patient while the individual is in residence.
Personnel who meet the three criteria specified in the proposed
paragraph would be excluded from the FFD program because the limited
nature of their involvement with the FFD program makes it unlikely that
they would be
[[Page 50480]]
subject to coercion or influence attempts to subvert the testing
process and the NRC is not aware of any reports indicating that these
types of individuals have been involved in any adverse incidents.
Therefore, the NRC concurs with the stakeholders that requiring such
individuals to be subject to the FFD program would be unnecessary.
However, proposed Sec. 26.25(a)(4) would require MROs and SAEs to
be subject to Part 26 (see the discussion of proposed Sec. 26.187
[Substance abuse expert] in Section VI of this document for a detailed
description of the SAE's roles and responsibilities under the FFD
program), as well as any EAP counselor who serves as the SAE for a
licensee's or other entity's FFD program. Individuals who serve in
these positions play the key roles of determining whether a non-
negative drug test result is an FFD policy violation (i.e., the MRO
under proposed Sec. 26.185) and whether an individual is fit to safely
and competently perform the job duties that require the individual to
be subject to this part (i.e., the SAE). Although the NRC recognizes
the significant logistical difficulties and costs that may be
associated with covering these individuals, the NRC concluded that MROs
and SAEs play such critical roles in the effective functioning of an
FFD program that ensuring their continuing honesty and integrity by
requiring them to be subject to the rule is warranted and invites
further comment on these provisions.
Proposed Sec. 26.25(b)(2) and (3) would retain the first sentence
of current Sec. 26.2(b) but divide it into two paragraphs. This
organizational change would be made to make it easier to locate these
requirements within the rule text and to support cross-referencing to
these paragraphs from other portions of the rule. The second sentence
of current Sec. 26.2(b) would be moved to proposed Sec. 26.3(e)
rather than retained in this paragraph because it addresses entities
who would not be subject to the rule, rather than individuals. The
proposed changes would be made to meet Goal 6 of the rulemaking, which
is to improve clarity in the organization and language of the rule, as
discussed in Section IV. B.
Proposed Sec. 26.25(c) would be added to provide that persons who
are covered by a program regulated by another Federal or State agency
that meets the performance objectives of Part 26 need not also be
covered by a licensee's or other entity's FFD program. Duplicate
testing and training requirements applicable to an appreciable number
of individuals working at nuclear facilities have become an increasing
problem as the facilities have implemented the Department of
Transportation's (DOT) drug and alcohol testing requirements [49 CFR
Part 40--65 FR 41944, August 9; 2001]. This proposed revision would
reduce the burden on some individuals who are currently subject to
Federal and State programs with requirements that duplicate those of
Part 26. Minor differences in specific program requirements for
conducting drug and alcohol testing would be unlikely to adversely
affect the ability of a licensee's or other entity's FFD program to
meet the performance objectives of this part. The licensee or other
entity would continue to be responsible for implementing any Part 26
program elements that may not be addressed by the alternate Federal or
State program. These program elements may include, but would not be
limited to, providing behavioral observation and initiating for-cause
testing, if necessary, when an individual who is covered by an
alternate program is on site at a licensee's or other entity's facility
and is performing the job duties that require the individual to be
subject to the rule, as well as immediate removal from duty of persons
whose fitness may be questionable.
Proposed Sec. 26.25(c)(1)-(c)(6) would list the necessary
characteristics of an alternative Federal or State program that, under
the proposed rule, licensees and other entities could rely upon to
satisfy the requirements of this part for an individual who is subject
both to Part 26 and an alternative program. Proposed Sec. 26.25(c)(1)
and (3) would permit licensees and other entities to rely on the
alternative program to meet the proposed rule's drug testing
requirements if the alternative program tests for the drugs and drug
metabolites that are specified in the proposed rule at or below the
cutoff levels established in the proposed rule and an HHS-certified
laboratory conducts the program's specimen validity and drug testing.
Similarly, proposed Sec. 26.25(c)(2) would permit licensees and other
entities to rely on the alternative program to meet the proposed rule's
alcohol testing requirements if the alternative program's alcohol
testing procedures and devices meet the proposed rule's requirements
and the alternative program uses cutoff levels that are at least as
stringent as those specified in proposed Sec. 26.103(a). Proposed
Sec. 26.25(c)(4) would permit the licensee or other entity to rely on
an alternative program's FFD training if that training addresses the
knowledge and abilities listed in proposed Sec. 26.29(a)(1)-(a)(10).
Proposed Sec. 26.25(c)(5) would permit licensees and other entities to
rely on the alternative program to meet the proposed rule's
requirements for an impartial and objective procedure for the review
and reversal of any findings of an FFD violation if the alternative
program provides such a procedure. And, finally, if the licensee or
other entity relies on the alternative program, proposed Sec.
26.25(c)(6) would require the licensee or other entity to ensure that
the alternative program would inform the licensee or other entity of
any FFD violations.
These proposed provisions would be consistent with the current and
proposed rules' approaches to permitting licensees and other entities
to rely on C/V FFD programs and program elements to meet the
requirements of this part if the C/V's program or program element meets
the requirements of this part, as discussed with respect to proposed
Sec. 26.21 [Fitness-for-duty programs]. In general, permitting
licensees and other entities to rely on FFD programs and program
elements that are implemented by others, when those programs or program
elements meet the requirements of this part, would fulfill the rule's
performance objectives and improve Part 26 by eliminating or modifying
unnecessary requirements, which is Goal 5 of this rulemaking, as
discussed in Section IV. B. However, an important difference between
the proposed rule's permission for licensees and other entities to rely
on the programs of other Federal and State agencies, compared to the
proposed rule's permission for licensees and other entities to rely on
C/V programs, is that the proposed rule would not require licensees and
other entities to audit the alternate Federal and State programs under
proposed Sec. 26.41 [Audits and corrective action]. Auditing Federal
and State programs would be unnecessary because these programs are
subject to other, equally effective audit and inspection requirements.
Relieving licensees and other entities who are subject to this part
from an audit requirement also would be in keeping with Goal 5 of this
rulemaking.
Proposed Sec. 26.25(d) would be added to clarify that individuals
who have applied for authorization to perform job duties that would
require them to be subject to Part 26 would also be subject to some
provisions of the proposed rule. The current Part 26 requires an
applicant for authorization to provide a written statement related to
his or her past activities under this part in current Sec.
26.27(a)(1); provide permission to the
[[Page 50481]]
licensee to conduct a suitable inquiry in current Sec. 26.27(a)(2);
and submit to pre-access testing in current Sec. 26.24(a)(1). The
proposed rule would impose similar requirements on applicants and add
others, such as random testing during the short time period that falls
between when a licensee or other entity collects specimens for a pre-
access test and then grants authorization to the individual. Therefore,
proposed Sec. 26.25(d) would ensure the internal consistency of the
proposed rule and would meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Section 26.27 Written Policy and Procedures
Proposed Sec. 26.27 [Written policy and procedures] would
reorganize and amend current Sec. 26.20 [Written policy and
procedures]. The proposed rule would reorganize the current section to
divide into separate paragraphs the requirements related to the FFD
policy and those related to FFD program procedures that are intermixed
within the current section. The proposed organizational change would be
made so that the requirements related to the FFD policy and procedures
would be easier to locate within this section, consistent with Goal 6
of this rulemaking, which is to improve clarity in the organization and
language of the rule, as discussed in Section IV. B.
Proposed Sec. 26.27(a) [General] would amend the first paragraph
of current Sec. 26.20, which requires licensees to establish and
implement written policies and procedures designed to meet the
performance objectives and specific requirements of this part and to
retain superseded copies of the policies and procedures. The proposed
rule would replace the term, ``licensee,'' in the current rule with the
phrase, ``licensees and other entities,'' because entities other than
licensees would be subject to this requirement, as discussed with
respect to proposed Sec. 26.3 [Scope]. The term, ``maintain,'' would
be added to the current requirement to ``establish and implement''
written policies and procedures to reflect the fact that licensees and
other entities who are subject to Part 26 must occasionally revise FFD
program policies and procedures to keep them current when FFD program
personnel or other aspects of the FFD program change. The proposed rule
would replace ``specific'' with the term, ``applicable,'' in the
proposed sentence because all the requirements in Part 26 would not
apply to all the licensees and other entities who would be subject to
the rule, as discussed with respect to proposed Sec. 26.3 [Scope]. The
proposed rule would also eliminate ``designed to'' from this sentence
because it is unnecessary. The records retention requirements contained
in the second sentence of the current paragraph would be moved to
proposed Sec. 26.213(d) in Subpart J [Recordkeeping and Reporting
Requirements], which groups together the recordkeeping and reporting
requirements that are interspersed throughout the current rule. These
proposed changes to the organization and language of current Sec.
26.27 would be made to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule, as
discussed in Section IV. B.
Proposed Sec. 26.27(b) [Policy] would amend current Sec.
26.20(a), which establishes requirements for the written FFD policy.
The proposed rule would expand the list of topics that the FFD policy
must address. The list of topics to be addressed by the FFD policy
would be expanded as a result of discussions with stakeholders during
the public meetings described in Section V. Stakeholders noted that the
list of topics in the current rule is incomplete because it does not
include many topics about which individuals who are subject to the
policy should be aware in order to be able to comply with the policy.
Therefore, the proposed rule would add topics to the policy content
requirements in current Sec. 26.20(a) to ensure that FFD policies will
be complete. This proposed change would be made to meet Goal 7 of this
rulemaking, as it relates to protecting the due process rights of
individuals who are subject to Part 26, as discussed in Section IV. B.
Proposed Sec. 26.27(b) would also add requirements for the written
FFD policy to be clear, concise, and readily available to all
individuals who are subject to the policy because neither the current
nor proposed rules require licensees and other entities to provide
site-specific FFD training to individuals. However, FFD policies may
vary between licensees and other entities with respect to, for example,
the sanctions that are applied for confirmed non-negative test results,
the cutoff levels used in drug or alcohol testing, or the time periods
within which an individual who has been selected for random testing
must report to the collection site. Under the proposed rule, the
written FFD policy would continue to be the primary means by which a
licensee or other entity would communicate local variations in FFD
policy. In the past, however, a few individuals challenged
determinations that they had violated a licensee's FFD policy on the
basis that they were not aware of the specific provisions of the policy
to which they were subject. Therefore, the proposed rule would add
requirements that the FFD policy must be clear, concise, and readily
available in order to promote individuals' awareness of the site-
specific FFD policy to which they are subject. This proposed change
would be made to meet Goal 7 of this rulemaking, as it relates to
protecting the due process rights of individuals who are subject to
Part 26.
The proposed rule would also add examples of acceptable methods to
make the written policy ``readily available'' to individuals who are
subject to the FFD policy, including, but not limited to, posting the
policy in various work areas throughout the licensee's or other
entity's facilities, providing individuals with brochures, or allowing
individuals to print the policy from a computer. These examples would
be added at the request of stakeholders during the public meetings
discussed in Section V, and would meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule.
Proposed Sec. 26.27(b)(1) would amend the second sentence of
current Sec. 26.20(a), which requires that ``the policy must address
the use of illegal drugs and abuse of legal drugs (e.g., alcohol,
prescription and over-the-counter drugs).'' Proposed Sec. 26.27(b)(1)
would expand this sentence to require the FFD policy to describe the
consequences of on-site or off-site use, sale, or possession of illegal
drugs in proposed Sec. 26.27(b)(i); the abuse of legal drugs and
alcohol in proposed Sec. 26.27(b)(ii); and the misuse of prescription
and over-the-counter drugs in proposed Sec. 26.27(b)(iii). The
proposed rule would replace the phrase, ``must address,'' in the
current sentence with the phrase, ``must describe the consequences
of,'' because stakeholders noted that ``must address'' is vague during
the public meetings discussed in Section V. The phrase, ``must describe
the consequences of,'' would clarify the information that the policy
must convey to ensure that individuals who are subject to the policy
are aware of the consequences of these actions, as specified in the
licensee's or other entity's FFD policy. These proposed changes would
be made to meet Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule, as discussed in Section
IV. B.
The proposed rule would add a new Sec. 26.27(b)(2), which would
require the FFD policy to state the time period
[[Page 50482]]
within which individuals must report to the collection site after being
notified that they have been selected for random testing, as specified
by the licensee or other entity. The proposed regulation would not
establish a time limit because there are a variety of circumstances
among the different entities who are subject to this rule that make it
impractical to establish a universal time limit. However, adding the
requirement for the licensee's or other entity's FFD policy to
establish and convey a time limit would be necessary because some
programs have not done so. As a result, circumstances have arisen in
which individuals who were selected for random testing intentionally
delayed reporting to the collection site in order to take steps to
subvert the testing process, such as obtaining an adulterant to bring
to the collection site or drinking large amounts of liquid to be able
to provide a dilute specimen. Further, the longer that an individual
who has abused illegal drugs or alcohol is able to delay providing
specimens for testing, the more likely it is that the concentrations of
an illegal drug or alcohol in the individual's urine, breath, or oral
fluids will decrease due to metabolism, with the result that the
concentrations may fall below the cutoff levels for those substances by
the time the specimens are collected and the individual's substance
abuse would not be detected. Therefore, the proposed rule would require
licensees and other entities to establish a time limit within which
individuals must report for random testing after they have been
notified to improve the effectiveness of FFD programs, consistent with
Goal 3 of this rulemaking. The proposed rule would also require the FFD
policy to convey this time limit to ensure that individuals are aware
of it, given that a failure to appear for testing within the prescribed
time limit may lead to the imposition of sanctions under the FFD
policy. This proposed change would be made to meet Goal 7 of this
rulemaking, as it relates to protecting the due process rights of
individuals who are subject to Part 26.
Proposed Sec. 26.27(b)(3) would be added to require the FFD policy
to inform individuals of the consequences of refusing to be tested and
attempting to subvert the testing process. This provision would be
added to ensure that persons who are subject to the rule are aware of
proposed Sec. 26.75(b), which would require licensees and other
entities to impose the sanction of permanent denial of authorization
for these actions. Proposed Sec. 26.27(b)(3) would be added to protect
the due process rights of individuals who are subject to drug and
alcohol testing under this part by ensuring that they are informed, in
advance, of the licensee's or other entity's policies to which they are
subject. Therefore, adding this requirement would meet Goal 7 of this
rulemaking with respect to protecting the due process rights of
individuals who are subject to Part 26, as discussed in Section IV. B.
Proposed Sec. 26.27(b)(4)(i) would amend current Sec.
26.20(a)(1), which requires the FFD policy to prohibit the consumption
of alcohol within an abstinence period of at least 5 hours preceding
``any scheduled working tour.'' The proposed rule would replace the
phrase, ``any scheduled working tour,'' with the phrase, ``the
individual's arrival at the licensee's or other entity's facility,'' as
a result of stakeholder comments on the language in the current rule at
the public meetings discussed in Section V. The stakeholders commented
that the current phrase lacks clarity and could be misinterpreted as
meaning, ``any working tour scheduled by the licensee or other
entity.'' If the phrase was so interpreted, individuals who are subject
to the rule may believe that, if they work on a weekend or work
overtime that is not part of their normally scheduled working tour, the
rule would permit them to consume alcohol within the 5-hour period
before they arrive at work, which would be incorrect. Therefore, the
language of the proposed rule would be revised to clarify that the pre-
work abstinence period applies to the 5 hours before an individual
arrives at the licensee's or other entity's facility for any purpose,
except if an individual is called in to perform an unscheduled working
tour, as discussed with respect to proposed Sec. 26.27(c)(3). This
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule, as
discussed in Section IV.B.
Proposed Sec. 26.27(b)(4)(ii) would retain current Sec.
26.20(a)(2).
Proposed Sec. 26.27(b)(5) would be added to require the FFD policy
to inform individuals that abstinence from alcohol during the 5 hours
preceding arrival at a licensee's or other entity's site, as required
in proposed Sec. 26.27(b)(4), may not be sufficient to ensure that an
individual is fit for duty upon reporting to work. Some individuals who
have complied with the 5-hour abstinence requirement could have BACs
above the cutoff levels specified in proposed Sec. 26.103 when they
arrive at the licensee's or other entity's facility, depending upon the
amount of alcohol and food that the individual consumed before the
abstinence period began, body weight, and other factors. This proposed
paragraph would be added to meet Goal 7 of this rulemaking with respect
to protecting the due process rights of individuals who are subject to
alcohol testing under Part 26 by ensuring that they are aware that the
required 5-hour abstinence period may be insufficient to assure they
have a BAC below the cutoff levels in this part when arriving for work.
Proposed Sec. 26.27(b)(6) would amend the last sentence of current
Sec. 26.20(a), which requires the FFD policy to address other factors
that could affect individuals' abilities to perform their duties safely
and competently, such as mental stress, fatigue, and illness. The
proposed provision would add a requirement for the FFD policy also to
address the use of prescription and over-the-counter medications that
could cause impairment at work. For example, some licensees or other
entities may require individuals to self-report to the FFD program
their use of any prescription medications that are labeled with a
warning indicating that use of the medication may cause impairment. The
licensee's or other entity's FFD policy may require that an individual
who is taking a medication that can cause impairment must be
temporarily re-assigned to job duties that the individual can perform
without posing a risk to the individual or public health and safety
while he or she is taking the medication. Therefore, the proposed rule
would require licensees and other entities to include such information
in the FFD policy to ensure that individuals are aware of the actions
they may be required to take when using these substances, consistent
with Goal 7 of this rulemaking with respect to protecting the due
process rights of individuals who are subject to the policy. The
addition of this requirement would also increase the internal
consistency of the rule because other portions of the proposed (and
current) rule establish requirements related to using prescription and
over-the-counter medications, including, for example, proposed Sec.
26.29(a)(6), which would require FFD training to address this topic,
and proposed Sec. 26.183(j)(2), which would require the MRO to
determine whether a non-negative confirmatory drug test result that is
due to using a prescription or over-the-counter medication represents
substance abuse. Therefore, the proposed requirement for the FFD policy
to address the use of prescription and over-the-counter medications
that
[[Page 50483]]
could cause impairment at work would also meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.27(b)(7) would amend current Sec. 26.20(b),
which requires the FFD policy to describe programs that are available
to individuals desiring assistance in dealing with drug, alcohol, or
other problems that may adversely affect their performance of their job
duties. Proposed Sec. 26.27(b)(7) would add fatigue as one of the
problems for which individuals may be seeking assistance because sleep
disorders (e.g., sleep apnea, insomnia, restless leg syndrome) can
substantially affect individuals' abilities to obtain sufficient
quality sleep. Poor quality sleep causes fatigue, which may degrade an
individual's ability to safely and competently perform his or her
duties. Sleep disorders affect a sizeable portion of the U.S. work
force. According to polls conducted by the NSF about two-thirds of U.S.
adults report experiencing one or more symptoms associated with
insomnia, sleep apnea, or restless leg syndrome at least a few nights a
week (National Sleep Foundation, 2003) and nearly one out of five (19
percent) report making occasional or frequent errors due to sleepiness
(National Sleep Foundation, 2000). Proposed Sec. 26.27(b)(7) would
ensure that individuals are aware of the services that are available
for diagnosing and treating sleep disorders that can adversely affect
their job performance. This proposed change would be made to meet Goal
2 of this rulemaking, which is to strengthen the effectiveness of FFD
programs at nuclear power plants by reducing the potential for worker
fatigue to adversely affect public health and safety and the common
defense and security, through establishing clear and more readily
enforceable requirements concerning the management of worker fatigue.
In addition, the proposed rule would replace the phrase, ``adversely
affect the performance of activities within the scope of this part,''
in the current provision with the phrase, ``could adversely affect an
individual's ability to safely and competently perform the job duties
that require an individual to be subject to this part,'' for the
reasons discussed with respect to proposed Sec. 26.23(c).
Proposed Sec. 26.27(b)(8) would retain the requirement in current
Sec. 26.20(d) that the FFD policy must specify the consequences of
violating the policy. The current requirements in this paragraph that
are related to the procedures that the licensee or other entity would
implement if an individual violates the FFD policy would be moved to
proposed Sec. 26.27(c) [Procedures], which addresses FFD program
procedures for organizational clarity.
Proposed Sec. 26.27(b)(9) would add a requirement for licensees'
and other entities' FFD policies to describe the individual's
responsibility to report legal actions, as defined in proposed Sec.
26.5 [Definitions]. The new requirement to report legal actions is
discussed with respect to proposed Sec. 26.61 [Self-disclosure and
employment history]. However, the proposed rule would require the FFD
policy to address the reporting of legal actions to ensure that
individuals are aware of it and are not at risk of being subject to
sanctions for failing to report any legal actions. This proposed change
would be made to meet Goal 7 of this rulemaking with respect to
protecting the due process rights of individuals who are subject to the
policy, as discussed in Section IV.B.
Proposed Sec. 26.27(b)(10) would add a requirement for the FFD
policy to describe the responsibilities of managers, supervisors, and
escorts to report FFD concerns. The current rule implies that managers
and supervisors have the responsibility to report FFD concerns in Sec.
26.22(a)(5), which requires managers and supervisors to be trained in
procedures ``for initiating appropriate corrective action.'' Similarly,
the last phrase of Sec. 26.22(b) requires that escorts be trained in
procedures ``for reporting problems to supervisory or security
personnel,'' and, therefore, also implies that escorts have a reporting
responsibility. However, the current rule does not explicitly state
that the FFD policy must convey this requirement. Therefore, the
proposed rule would add Sec. 26.27(b)(10) to enhance the internal
consistency of the rule. This proposed change would be made to meet
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule.
Proposed Sec. 26.27(b)(11) would add a requirement for the FFD
policy to state that individuals who are subject to the rule must
report FFD concerns. The proposed provision would be added for
consistency with proposed Sec. 26.33 [Behavioral observation], which
would require individuals who are subject to the rule to perform
behavioral observation and to report an FFD concern if they detect
behaviors that may indicate possible use, sale, or possession of
illegal drugs; use or possession of alcohol on site or while on duty;
or impairment from fatigue or any cause that, if left unattended, may
constitute a risk to the health and safety of the public. Proposed
Sec. 26.29 [Training] would establish a requirement for all
individuals who are subject to the rule to be trained in behavioral
observation. As a group, these proposed requirements would be added to
enhance the effectiveness of Part 26 in assuring the early detection of
individuals who are not fit to perform the job duties that require them
to be subject to this part, which is one of the performance objectives
that FFD programs must meet, as discussed with respect to current Sec.
26.10(b) and proposed Sec. 26.23(c). The proposed provision would also
be added to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003, as
discussed in Section IV.B. The specific requirement for licensees' and
other entities' FFD policies to state that individuals must report FFD
concerns in proposed Sec. 26.27(b)(11) would be necessary to ensure
that individuals are aware of their responsibility to report concerns
(and that sanctions may be imposed if they do not) to meet Goal 7 of
this rulemaking with respect to protecting the due process rights of
individuals who are subject to the policy, as discussed in Section
IV.B.
Proposed Sec. 26.27(c) [Procedures] would combine the requirements
related to procedures contained in current Sec. 26.20(c)-(e), and
would add other requirements, as follows:
Proposed Sec. 26.27(c)(1) would retain the requirements in current
Sec. 26.20(c). The phrase, ``privacy and due process rights of an
individual,'' would be added to clarify the requirement for
``protecting the employee,'' contained in current Sec. 26.20(c). For
example, individuals' privacy rights under the proposed rule include,
but are not limited to, requirements for the protection of personal
information that is collected about the individual and individual
privacy during specimen collections. Examples of individuals' rights to
due process under the proposed rule include, but are not limited to,
the right to an objective and impartial review of a determination that
the individual has violated the FFD policy, the right to advance
knowledge of rule provisions and FFD policy requirements that affect
the individual, and the right to request testing of a split specimen or
retesting an aliquot of a single specimen, if the individual questions
a confirmed non-negative test result. This proposed change would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the organization and language of the rule.
[[Page 50484]]
Proposed Sec. 26.27(c)(2)(i) and (c)(2)(ii) would divide current
Sec. 26.20(d) into separate paragraphs that address different topics.
Proposed Sec. 26.27(c)(2)(i) would retain the requirement for
licensees and other entities to have procedures that specify the
immediate and followup actions that must be taken if an individual is
determined to have been involved in the use, sale, or possession of
illegal drugs. Proposed Sec. 26.27(c)(2)(ii) would continue to require
licensees' and other entities' procedures to specify the immediate and
followup actions to be taken if an individual is determined to have
consumed alcohol to excess before the mandatory pre-work abstinence
period, during the mandatory pre-work abstinence period, or while on
duty, as determined by a test that measures BAC. The proposed rule
would divide the current paragraph into two paragraphs to meet Goal 6
of this rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.27(c)(2)(iii) and (c)(2)(iv) would require that
licensees and other entities who are subject to the rule must prepare
written procedures for implementing the FFD program that address
followup actions for attempted subversion of the testing process.
Proposed Sec. 26.27(c)(2)(iii) would require procedures to specify
immediate and followup actions if an individual has attempted to
subvert the testing process by adulterating, substituting, or diluting
specimens (in vivo or in vitro), or by any other means. Proposed Sec.
26.27(c)(2)(iv) would require procedures to address the actions to be
taken if an individual has refused to provide a specimen for testing.
The proposed rule would add these provisions for consistency with
proposed Sec. 26.75(b), which would require licensees and other
entities to terminate an individual's authorization and, thereafter,
permanently deny authorization to any individual who has committed any
act or attempted act to subvert the testing process, including refusing
to provide a specimen and providing or attempting to provide a
substituted or adulterated specimen, for any test required under this
part. Adding the proposed requirements for procedures to address these
circumstances would meet Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule.
Proposed Sec. 26.27(c)(2)(v) would require that the written
procedures must address immediate and followup actions for individuals
who have had drug- or alcohol-related legal actions taken against them,
as defined in proposed Sec. 26.5 [Definitions]. The proposed paragraph
would support related provisions in proposed Sec. 26.69(d)
[Maintaining authorization with other potentially disqualifying FFD
information], which, in general, require licensees and other entities
to take certain steps if an individual has had drug- or alcohol-related
legal actions taken against them while they are maintaining
authorization to perform the job duties that require them to be subject
to this part. Adding the proposed requirement for procedures to address
these circumstances would meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule, and
ensure the internal consistency of the proposed rule.
Proposed Sec. 26.27(c)(3) would amend current Sec. 26.20(e). The
proposed paragraph would continue to require licensees and other
entities to have procedures to describe the process that the licensee
or other entity will use to ensure that individuals who are called in
to perform an unscheduled working tour are fit for duty. The proposed
paragraph would also retain the requirement in the last sentence of
current Sec. 26.20(e)(3) that consumption of alcohol within the 5-hour
pre-duty abstinence period may not by itself preclude a licensee or
other entity from using individuals who are needed to respond to an
emergency. However, this sentence would be moved from the end of the
last sentence in the current paragraph to the introductory paragraph of
proposed Sec. 26.27(c)(3) because it applies generally to the topic of
this proposed paragraph, rather than only to the topic addressed in
current Sec. 26.20(e)(3). This proposed change would be made to meet
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule, as discussed in Section IV. B.
The proposed rule also would retain the other requirements of
current Sec. 26.20(e), as follows: Proposed Sec. 26.27(c)(3)(i) would
retain current Sec. 26.20(e)(1), which requires the individual who is
called in to state whether the individual considers himself or herself
fit for duty and whether he or she has consumed alcohol within the pre-
duty abstinence period stated in the FFD policy. Proposed Sec.
26.27(c)(3)(ii)(A) and (c)(3)(ii)(B) would retain current Sec.
26.20(e)(2) and the first sentence of current Sec. 26.20(e)(3), which
require that an individual who reports that he or she has used alcohol
and is called in must be subject to alcohol testing, and that the
licensee or other entity must establish controls and conditions under
which an individual who has consumed alcohol may perform work safely.
The proposed rule would also add a requirement to proposed Sec.
26.27(c)(3)(i) and (c)(3)(iii). The proposed rule would require an
individual who is called in to state whether he or she considers
himself or herself to be fit for duty, in addition to stating whether
he or she has consumed alcohol. The proposed rule would add this
requirement to recognize that there are conditions other than the
consumption of alcohol that may cause an individual to be unable to
safely and competently perform duties, including, but not limited to,
fatigue (as discussed with respect to Subpart I [Managing Fatigue]).
Therefore, requiring individuals to report other conditions that may
cause them to be impaired when called in to perform an unscheduled
working tour, under proposed Sec. 26.27(c)(3)(i), would strengthen the
effectiveness of FFD programs by providing the licensee or other entity
with more complete information about the individual's condition to
determine whether there is a need to establish controls and conditions
under which the individual may safely perform work, as required under
proposed Sec. 26.27(c)(3)(iii). These proposed changes would be made
to meet Goal 3 of this rulemaking, which is improve the effectiveness
and efficiency of FFD programs.
Proposed Sec. 26.27(c)(3)(ii)(C) would be added to clarify that
licensees and other entities may not impose sanctions if an individual
is called in for an unscheduled working tour and has consumed alcohol
during the pre-duty abstinence period specified in the FFD policy.
During the public meetings discussed in Section V, the stakeholders
requested this clarification to ensure that, if an individual who is
called in unexpectedly has a confirmed positive test result for
alcohol, he or she would not be subject to the sanctions that are
otherwise required under this part for a confirmed positive alcohol
test result. The NRC concurs with this recommendation because sanctions
for the consumption of alcohol in these circumstances would be
inappropriate, given that the individual would have been unaware that
he or she would be called in to work. The proposed revision also would
be consistent with the original intent of the rule. Therefore, the
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule.
Proposed Sec. 26.27(c)(4) would be added to require that FFD
procedures must describe the process to be followed when another
individual's behavior
[[Page 50485]]
raises an FFD concern and for reporting the concern. As discussed with
respect to proposed Sec. 26.27(b)(11), this proposed paragraph would
be added for consistency with proposed Sec. 26.33 [Behavioral
observation], which would establish a new requirement that all
individuals who are subject to the rule must perform behavioral
observation and report any FFD concerns, and proposed Sec. 26.29
[Training], which requires that individuals who are subject to this
part must be trained to perform behavioral observation. The proposed
requirement would be added to meet Goal 3 of this rulemaking, which is
to improve the effectiveness and efficiency of FFD programs, and Goal
4, which is to improve consistency between FFD requirements and access
authorization requirements established in 10 CFR 73.56, as supplemented
by orders to nuclear power plant licensees dated January 7, 2003.
Proposed Sec. 26.27(d) would retain the requirements of current
Sec. 26.20(f).
Section 26.29 Training
Proposed Sec. 26.29 [Training] would combine and amend current
Sec. 26.21 [Policy communications and awareness training] and Sec.
26.22 [Training of supervisors and escorts]. The proposed section would
require that all individuals who are subject to the rule must receive
the same training, to include, for example, behavioral observation,
whereas current Sec. 26.22 requires that only supervisors and escorts
must receive behavioral observation training. Increasing the number of
individuals who are trained in behavioral observation would enhance the
effectiveness of FFD programs by increasing the likelihood of detecting
potential impairment, consistent with Goal 3 of this rulemaking, as
discussed in Section IV.B.
Proposed Sec. 26.29(a) [Training content] would combine the
training topics listed in current Sec. Sec. 26.21(a)(1)-(a)(5),
26.22(a)(1)-(a)(5), and 26.22(b). The required training topics would be
rewritten in terms of knowledge and abilities (KAs) to be consistent
with terminology used by licensees and other entities in other required
training programs to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.29(a)(1) would combine current Sec. 26.21(a)(1)
with the latter portion of current Sec. 26.21(a)(5). Consistent with
the current training requirements, the proposed paragraph would require
licensees and other entities to ensure that individuals who are subject
to the FFD policy have knowledge of the FFD policy and procedures that
apply to them, the methods used to implement the policy and procedures,
and the consequences of violating the policy and procedures.
Proposed Sec. 26.29(a)(2) would retain the requirement in current
Sec. 26.22(a)(1) that licensees and other entities who are subject to
the rule must ensure that individuals understand their roles and
responsibilities under the FFD program, such as avoiding substance
abuse and reporting for testing within the time limit specified in FFD
program procedures.
Proposed Sec. 26.29(a)(3) would amend the terminology used in
current Sec. 26.22(a)(2), which requires FFD training to address the
roles and responsibilities of others, such as the personnel, medical,
and employee assistance program (EAP) staffs. The proposed paragraph
would replace the references to the ``personnel'' function and
``medical'' staff in current Sec. 26.22(a)(2) with ``human resources''
and ``FFD'' staff, respectively. The proposed rule would also move the
reference to the MRO into this paragraph from current Sec.
26.21(a)(3). These proposed changes would be made to update the
terminology in this paragraph to be consistent with other terms used
throughout the regulation to meet Goal 6 of this rulemaking, which is
to improve clarity in the organization and language of the rule.
Proposed Sec. 26.29(a)(4) and (a)(5) would amend current Sec.
26.21(a)(4) and (a)(2), respectively, by changing some of the language
used in the current provisions. Current Sec. 26.29(a)(4) requires FFD
training to inform individuals who are subject to the rule of any EAPs
that are available to them. The proposed rule would eliminate the
reference to EAPs ``provided by the licensee'' in the current provision
and amend it as ``EAP services available to the individual'' because
there are other entities who would be subject to this requirement under
the proposed rule. Proposed Sec. 26.29(a)(5) would amend current Sec.
26.21(a)(2) by replacing the phrase, ``abuse of drugs and misuse of
alcohol,'' with ``abuse of illegal and legal drugs and alcohol'' for
greater accuracy in describing the required knowledge. These proposed
changes would be made to meet Goal 6 of this rulemaking, which is to
improve clarity in the language of the rule.
Proposed Sec. 26.29(a)(6) would retain the portion of current
Sec. 26.21(a)(3) which requires licensees to ensure that individuals
understand the effects of prescription and over-the-counter drugs and
dietary factors on job performance. The proposed rule would add a
requirement for FFD training to address the effects of illness, mental
stress, and fatigue on job performance, in order to ensure that
individuals understand the bases for the licensee's or other entity's
FFD policy regarding these conditions. The requirement in the last
sentence of current Sec. 26.20(a) for the FFD policy to address these
factors would be moved to proposed Sec. 26.27(b)(6) because proposed
Sec. 26.27(b) would address FFD policy requirements. These proposed
changes would be made to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.29(a)(7) would retain the portion of current
Sec. 26.21(a)(3) that requires licensees and other entities to ensure
that individuals who are subject to the rule understand the effects of
prescription and over-the-counter drugs and dietary factors on drug and
alcohol test results. Examples of medications, supplements, and dietary
factors that can affect drug and alcohol test results may include, but
are not limited to, ingesting foods containing poppy seeds, drinking
coca tea, using some liquid or inhalant cold and cough preparations
containing alcohol or codeine, and taking supplements containing hemp
oil.
Proposed Sec. 26.29(a)(8) and (a)(9) would retain the requirements
in current Sec. 26.22(a)(3) and (a)(4), respectively.
Proposed Sec. 26.29(a)(10) would amend current Sec. 26.22(a)(5).
The proposed provision would retain the current requirement for FFD
training to address the licensee's or other entity's process for
initiating appropriate corrective action if an individual has an FFD
concern about another person, to include referral to the EAP. The
proposed rule would add a requirement for FFD training to ensure that
individuals understand their responsibility to report FFD concerns to
the person(s) who are designated in FFD program procedures to receive
such reports. This proposed change would be made for consistency with
proposed Sec. 26.33 [Behavioral observation], which would require
individuals to perform behavioral observation and report any FFD
concerns, as discussed with respect to proposed Sec. 26.27(b)(11), and
proposed Sec. 26.27(c)(4), which would require procedures for
implementing the requirement. This group of inter-related proposed
requirements would be added to meet Goal 3 of this rulemaking, which is
to improve the effectiveness and efficiency of FFD programs, and Goal 4
of this rulemaking, which is to improve consistency between FFD
[[Page 50486]]
requirements and access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
A new Sec. 26.29(b) [Comprehensive examination] would require that
individuals who are subject to the FFD program must demonstrate
attainment of the KAs specified in proposed Sec. 26.29(a) by passing a
comprehensive examination. This new requirement would be added because
there have been several instances since Part 26 was first promulgated
in which individuals were able to overturn determinations that they had
violated a licensee's FFD policy on the basis that they had not
understood the information they received during FFD training and so
could not be expected to comply with the requirements of the policy.
Therefore, the proposed rule would require individuals to demonstrate
their attainment of the KAs listed in proposed Sec. 26.29(a) to ensure
that the FFD training has been effective. The proposed rule would also
require remedial training for those who fail to achieve a passing score
on the examination. Proposed Sec. 26.29(b) would require the
examination to include at least one question for each KA, and establish
a minimum passing score of 80 percent. These proposed requirements
would be modeled on other required training programs that have been
successful in ensuring that examinations are valid and individuals have
achieved an adequate understanding of the subject matter. The proposed
paragraph would be added to meet the portion of Goal 3 of this
rulemaking that relates to improving the effectiveness of FFD programs
by establishing a method to ensure that individuals understand the
requirements with which they must comply.
The proposed paragraph also would permit the use of various media
for administering the comprehensive examination, in order to achieve
the efficiencies associated with computer-based training and testing,
for example, and other new training delivery technologies that may
become available. Permitting the use of various media to administer the
examination would meet the portion of Goal 3 of this rulemaking that
relates to improving the efficiency of FFD programs. The proposed
permission would also meet Goal 5, which is to improve Part 26 by
eliminating or modifying unnecessary requirements, by providing
flexibility in the methods that licensees and other entities may use to
administer the required examination.
Proposed Sec. 26.29(c) [Training administration] would combine and
amend the portions of current Sec. 26.21(b) and Sec. 26.22(c) that
require FFD training for individuals, supervisors, and escorts before
they are permitted to perform duties that require them to be subject to
this part.
Proposed Sec. 26.29(c)(1) would require that all personnel who are
subject to this part must complete FFD training before the licensee or
other entity grants initial authorization to the individual, as defined
in proposed Sec. 26.55 [Initial authorization]. The proposed rule
would also require that an individual's training must be current before
the licensee or other entity grants an authorization update or
reinstatement to the individual, as defined in proposed Sec. 26.57
[Authorization update] and Sec. 26.59 [Authorization reinstatement],
respectively. The proposed paragraph also would eliminate the
requirement to upgrade training for newly assigned supervisors within 3
months of a supervisory assignment in current Sec. 26.22(c), because
all personnel would receive the same training and be required to
complete the training before a licensee or other entity grants
authorization to any individual. The proposed changes would be made for
consistency with the new requirements related to granting and
maintaining authorization that would be established in proposed Subpart
C [Granting and Maintaining Authorization], as discussed with respect
to that subpart.
Proposed Sec. 26.29(c)(2) would retain but combine the
requirements for annual refresher training in current Sec. 26.21(b),
which addresses individuals who are subject to this part, and Sec.
26.22(c), which addresses supervisors and escorts. The current
requirements would be combined because all personnel would receive the
same training under the proposed rule. The proposed paragraph would
also permit individuals who pass a comprehensive ``challenge''
examination that demonstrates their continued understanding of the FFD
program requirements to be excused from the refresher training that
would otherwise be required under the proposed paragraph. The challenge
examination would be required to meet the examination requirements
specified in proposed Sec. 26.29(b) [Comprehensive examination] and
individuals who did not pass would undergo remedial training.
Permitting individuals to pass a comprehension examination rather than
take refresher training each year would ensure that they are retaining
their FFD knowledge and abilities while reducing some costs associated
with meeting the annual refresher training requirement. Therefore, this
proposed change would meet Goal 5 of this rulemaking, which is to
improve Part 26 by eliminating or modifying unnecessary requirements.
Proposed Sec. 26.29(c)(3) would permit licensees and other
entities to use various media, in addition to traditional classroom
instruction, for presenting initial and refresher training for the same
reasons discussed with respect to the portion of proposed Sec.
26.29(b) [Comprehensive examination] that would permit licensees and
other entities to use various media to administer the comprehensive
examination. The proposed requirements for a licensee or other entity
to monitor the completion of training and provide access to an
instructor or subject matter expert should ensure that individuals who
are trained using different media would achieve the same understanding
as persons who are trained in a classroom setting with an instructor
present. This proposed flexibility may reduce the costs associated with
presenting initial and refresher training only in a classroom setting.
Therefore, this proposed change would meet Goal 5 of this rulemaking,
which is to improve Part 26 by eliminating or modifying unnecessary
requirements.
To meet the annual refresher training requirement for individuals,
proposed Sec. 26.29(d) [Acceptance of training] would permit licensees
and other entities to accept FFD training that was provided by other
licensees and entities who are subject to the rule. Licensees and other
entities would also be permitted to accept a passing result from a
comprehensive examination that was administered by another Part 26 FFD
program in lieu of refresher training, if the examination meets the
requirements of proposed Sec. 26.29(b) [Comprehensive examination].
Proposed Sec. 26.29(c)(4) would incorporate item 3.3 of NUREG-1385,
``Fitness for Duty in the Nuclear Power Industry: Responses to
Implementation Questions,'' which recommends acceptance of prior
training. The proposed provision would also meet Goal 4 of this
rulemaking, which is to improve consistency between FFD requirements
and access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003. These access authorization requirements also permit licensees
and other entities to rely on training and examinations administered by
other Part 26 programs.
[[Page 50487]]
Section 26.31 Drug and Alcohol Testing
Proposed Sec. 26.31 [Drug and alcohol testing] would rename
current Sec. 26.24 [Chemical and alcohol testing]. The proposed rule,
in general, would replace the phrase, ``chemical testing,'' with the
term, ``drug testing,'' because the testing for chemicals that is
required in the rule is performed only in the context of urine drug
testing. Therefore, the term, ``drug testing,'' more accurately conveys
the nature of the testing that is performed. This proposed change would
be made to meet Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule.
Proposed Sec. 26.31(a) [General] would retain but update the
language in current Sec. 26.24(a) to be consistent with the new
terminology used throughout the rule, as discussed in proposed Sec.
26.5 [Definitions]. For example, the proposed rule would replace
``licensee'' with ``licensees and other entities'' to refer to the
entities who are subject to the rule. This proposed change would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the language of the rule.
Proposed Sec. 26.31(b) [Assuring the honesty and integrity of FFD
program personnel] would amend current Section 2.3 in Appendix A to
Part 26, as explained below.
Proposed Sec. 26.31(b)(1) would amend the first paragraph of
current Section 2.3 in Appendix A to Part 26, which requires licensees
to carefully select and monitor persons responsible for administering
the testing program to assure they meet the highest standards of
honesty and integrity. The proposed rule would replace the current list
of individuals who would be subject to this requirement with a cross-
reference to Sec. 26.25(a)(4) of the proposed rule, which specifies,
in detail, the FFD program personnel who must be subject to the FFD
program. This cross-reference would be added to avoid repeating the
list of personnel in this paragraph.
The proposed paragraph would also add a reference to factors, other
than a personal relationship with an individual who is subject to
testing, that have the potential to cause an individual to be subject
to influence attempts or may adversely affect the honesty and integrity
of FFD program personnel. In addition to a personal relationship with
an individual who is subject to testing, factors that could cause an
individual to be compromised may include, but would not be limited to,
a substance abuse problem [as discussed with respect to proposed Sec.
26.25(a)(4)] or financial problems. Therefore, the proposed rule would
add a reference to these additional factors to more accurately
characterize the scope of potential concerns that licensees and other
entities must consider when selecting and monitoring the honesty and
integrity of FFD program personnel. The proposed changes would be made
to meet Goal 6 of this rulemaking, which is to improve clarity in the
language of the rule.
Proposed Sec. 26.31(b)(1)(i) would amend current Section 2.3(2) in
Appendix A to Part 26 in response to implementation questions regarding
the current requirements that the NRC staff has received since Part 26
was first promulgated as well as discussions with stakeholders during
the public meetings discussed in Section V. In response to numerous
questions from licensees, the proposed paragraph would clarify that the
background investigations, credit and criminal history checks, and
psychological evaluations that are required for persons who are granted
unescorted access to protected areas in nuclear power plants are
acceptable when determining the honesty and integrity of FFD program
personnel. The proposed rule would retain the term, ``appropriate,'' in
the current rule for two reasons. First, it would be used to indicate
that, for FFD program personnel who are employed by entities who are
subject to the rule but are not nuclear power plants, the requirements
may be met through investigations, checks, and evaluations that provide
the information needed to determine the honesty and integrity of FFD
program personnel but may differ from those required under nuclear
power plant access authorization programs. In addition, the proposed
rule would retain the term, ``appropriate,'' because it has particular
relevance to the requirement for licensees and other entities to
conduct criminal history checks for FFD program personnel. In some
cases, licensees and other entities cannot legally obtain the same type
of criminal history information about FFD program personnel as they are
able to obtain for other individuals who are subject to Part 26.
Therefore, the term, ``appropriate,'' would be used to indicate that
local criminal history checks for FFD program personnel who do not have
unescorted access to nuclear power plant protected areas are
acceptable. These proposed changes would be made to meet the portion of
Goal 6 of this rulemaking that pertains to improving clarity in the
language of the rule.
The requirement in current Section 2.3(2) in Appendix A to Part 26
for ``appropriate background checks and psychological evaluations'' to
be ``conducted at least once every three years'' would be relaxed to
require that credit and criminal history checks and updated
psychological assessments be conducted nominally every 5 years. The
proposed rule would relax the current requirement for several reasons.
First, the NRC is not aware of any instances in which licensees and
other entities have identified new information about FFD program
personnel from updating the background checks and psychological
assessments that had not already been identified through other avenues,
including self-reports by FFD program personnel, drug and alcohol
testing, and behavioral observation. However, the NRC continues to
believe that the required updates provide an independent method to
verify the ongoing honesty and integrity of FFD program personnel that
is necessary because of the critical importance of FFD program
personnel in assuring program effectiveness. Therefore, the proposed
rule would retain the current requirement for updated background checks
and psychological assessments but would reduce the required frequency
of these updates from every 3 years to every 5 years. This proposed
change would be made to meet Goal 5 of this rulemaking, which is to
improve Part 26 by eliminating or modifying unnecessary requirements.
In addition, the proposed frequency for these updates would increase
the consistency of Part 26 with access authorization requirements
established in 10 CFR 73.56, as supplemented by orders to nuclear power
plant licensees dated January 7, 2003, which is Goal 4 of this
rulemaking.
Proposed Sec. 26.31(b)(1)(ii) would amend current Section 2.3(1)
in Appendix A to Part 26 for clarification in response to the many
implementation questions that have arisen since the regulation was
published. In the current rule, individuals who have a personal
relationship with the individual being tested (i.e., a donor), such as
the donor's ``supervisors, coworkers, and relatives,'' are prohibited
from performing any ``collection, assessment, or evaluation
procedures'' involving the individual being tested. The restriction on
``supervisors, coworkers, and relatives'' was included in the current
rule to provide examples of the ``personal relationships'' referenced
in the introductory paragraph of current Section 2.3 in Appendix A to
Part 26. The restriction on coworkers in the current rule has been
misinterpreted by some licensees as meaning that no one
[[Page 50488]]
who is an employee of the same corporation may be involved in
collection, assessment, or evaluation procedures. However, in a large
corporation, there will be many individuals who are employed by the
same corporation who do not have personal relationships with FFD
program personnel, specifically, or with other individuals who are
subject to testing, in general. Therefore, in proposed Sec.
26.31(b)(1)(ii), the phrase, ``in the same work group,'' would be added
to clarify that the example regarding coworkers pertains to individuals
who report to the same manager. For example, FFD program personnel
report to the FFD program manager and so would be considered
``coworkers in the same work group'' to whom the proposed restriction
would apply. In addition, the proposed paragraph would add a reference
to determinations of fitness (discussed with respect to proposed Sec.
26.189 [Determination of fitness]) to provide a clarifying example of
the assessment and evaluation procedures that FFD program personnel
would be prohibited from performing if the FFD program staff member has
a personal relationship with the subject individual. These proposed
changes would be made to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.31(b)(1)(iii) would relax the prohibition on
individuals who have ``personal relationships'' with the donor from
performing specimen collection procedures in current Section 2.3(1) in
Appendix A to Part 26 in response to stakeholder requests during the
public meetings discussed in Section V. With respect to specimen
collections, stakeholders were convincing that the current restriction
imposes an unnecessary burden when the objective of ensuring the
integrity of specimen collections in these circumstances could be
achieved by other means. Therefore, in proposed Sec. 26.31(b)(1)(iii),
individuals who have a personal relationship with a donor would be
permitted to collect specimens, if the collection and preparation of
the specimens for shipping is monitored by another individual who does
not have a personal relationship with the donor and is not a
supervisor, a coworker in the same work group, or a relative of the
donor. The proposed rule would require that the independent individual
who is designated to monitor the collection must be trained to monitor
specimen collections. The proposed paragraph would also provide
examples of the types of individuals who may monitor the integrity of
specimen collection procedures in these circumstances, including but
not limited to, security force or quality assurance personnel. This
proposed change would be made to meet Goal 5 of this rulemaking, which
is to improve Part 26 by eliminating or modifying unnecessary
requirements, by permitting monitored collections in these
circumstances while continuing to assure the integrity of specimen
collections from FFD program personnel. The proposed rule would retain
the prohibition on individuals who have personal relationships with the
donor from performing assessment and evaluation procedures because
monitoring of these activities by qualified, independent personnel
would not be feasible.
Proposed Sec. 26.31(b)(1)(iv) would be added to prohibit a
collector who has a personal relationship with the donor from acting as
a urine collector under monitoring, if a directly observed collection
is required. This proposed prohibition would be necessary to minimize
embarrassment to the donor (and the collector) during a directly
observed collection. The proposed paragraph would be added to meet Goal
7 of this rulemaking, which is to protect the privacy and due process
rights of individuals who are subject to Part 26.
Proposed Sec. 26.31(b)(1)(v) would amend current Section 2.3(3) in
Appendix A to Part 26 to require that MROs who are on site at a
licensee's or other entity's facility must be subject to behavioral
observation. For the purposes of the proposed paragraph, a ``facility''
would include, but is not limited to, a licensee's or other entity's
corporate offices and any medical facilities that are operated by the
licensee or other entity. The proposed requirement would be added
because MROs are ``persons responsible for administering the testing
program,'' but some FFD programs have not included MROs in the
behavioral observation element of their programs. However, the proposed
rule would limit the behavioral observation of MROs to those times when
they are on site at a licensee's or other entity's facility, in order
to permit licensees and other entities to continue relying on the
services of MROs who normally work independently, often alone, in
offices at a geographical distance from the licensee's or other
entity's facilities so that behavioral observation is impractical.
Limiting the proposed requirement for behavioral observation of MROs to
those instances in which the MRO is working at a licensee's or other
entity's facility would be adequate to assure the continuing honesty
and integrity of these MROs because MROs who work off site would not be
interacting on a daily basis with other individuals who are subject to
the FFD program. Therefore, off-site MROs would be less likely to be
subject to potential influence attempts than MROs who normally work on
site because they are generally inaccessible. Further, the proposed
rule would continue to require all MROs to be subject to the other FFD
program elements that are required in this proposed Subpart, including
drug and alcohol testing and regular psychological assessments and
background investigations, which would permit licensees and other
entities to monitor off-site MROs' honesty and integrity. This proposed
relaxation would be added to meet Goal 5 of this rulemaking, which is
to improve Part 26 by eliminating or modifying unnecessary
requirements.
Proposed Sec. 26.31(b)(2) would provide another relaxation related
to collecting specimens from FFD program personnel. The proposed
paragraph would permit FFD program personnel to submit specimens for
testing at collection sites that meet the requirements of 49 CFR Part
40, ``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs'' (65 FR 41944; August 9, 2001). As discussed
with respect to proposed Sec. 26.31(b)(1), some FFD program personnel,
such as contract MROs and EAP staff members, normally work at locations
that are so distant from a licensee's collection site(s) as to make it
impractical for them to be randomly tested at a licensee's or other
entity's collection site. Permitting these FFD program personnel to be
tested at local collection sites that follow similar procedures would
be adequate to meet the goal of ensuring their continuing honesty and
integrity. Therefore, the proposed paragraph would be added to meet
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating
or modifying unnecessary requirements.
Proposed Sec. 26.31(c) [Conditions for testing] would replace
current Sec. 26.24(a)(1)-(a)(4). The proposed paragraph would list the
situations in which testing is required in separate paragraphs, such as
``pre-access,'' ``for cause,'' and ``post-event'' testing, to clarify
that each situation for which testing is required stands on its own.
The current provision in Sec. 26.24(a)(3), in particular, has led to
confusion and misinterpretation of the regulations, to be corrected as
noted below. Specific requirements for conducting the testing would be
addressed in proposed Subparts E [Collecting Specimens for
[[Page 50489]]
Testing], F [Licensee Testing Facilities], and G [Laboratories
Certified by the Department of Health and Human Services]. The proposed
rule would reorganize and amend current Sec. 26.24(a)(1)-(a)(4) to
meet Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule.
Proposed Sec. 26.31(c)(1) [Pre-access] would amend current Sec.
26.24(a)(1), which requires pre-access testing within 60 days before
the initial granting of unescorted access to protected areas or
assignment to job duties within the scope of this part. The proposed
paragraph would introduce the concepts of ``initial authorization,''
``authorization update,'' and ``authorization reinstatement,'' which
refer to categories of requirements that licensees and other entities
must meet in order to assign an individual to job duties which require
the individual to be subject to Part 26. Section 26.65 [Pre-access drug
and alcohol testing] in Subpart C [Granting and Maintaining
Authorization] of the proposed rule would specify detailed requirements
for conducting pre-access testing.
Proposed Sec. 26.31(c)(2) [For cause] and Sec. 26.31(c)(3) [Post
event] would clarify and amend current Sec. 26.24(a)(3), as follows:
Proposed Sec. 26.31(c)(2) [For cause] would continue to require
for-cause testing in response to any observed behavior or physical
condition indicating possible substance abuse. The proposed rule would
also retain the current requirement for testing if the licensee or
other entity receives credible information that an individual is
engaging in substance abuse. The term, ``substance abuse,'' would be
defined in proposed Sec. 26.3 [Definitions].
Proposed Sec. 26.31(c)(3) [Post event] would amend the portion of
current Sec. 26.24(a)(3) that requires drug and alcohol testing when
an event involving a failure in individual performance leads to
significant consequences. The proposed rule would amend the current
provision because it has been subject to misinterpretation and numerous
questions from licensees.
The phrase, ``if there is reasonable suspicion that the worker's
behavior contributed to the event,'' in current Sec. 26.24(a)(3) has
been subject to misinterpretation. The location of this phrase at the
end of the list of conditions under which post-event testing must be
performed has led some licensees to conclude that this phrase applies
only to events involving actual or potential substantial degradations
of the level of safety of the plant. Other licensees have
misinterpreted the term, ``reasonable suspicion'' as meaning,
``reasonable suspicion of substance abuse,'' or some other ``illegal''
or ``disreputable'' activity. Neither of these interpretations is
consistent the intent of this paragraph. Therefore, to clarify the
intent of the provision, the proposed rule would eliminate the phrase,
``if there is reasonable suspicion that the worker's behavior
contributed to the event,'' from the end of the list of significant
events that require post-event testing and, instead, require post-event
testing as soon as practical after significant events [as listed in
proposed Sec. 26.31(c)(3)(i)-(c)(3)(iii)] involving a human error that
may have caused or contributed to the event. The proposed rule would
use the term, ``human error,'' rather than the current term, ``worker's
behavior,'' to emphasize that post-event testing would be required for
acts that unintentionally deviated from what was planned or expected in
a given task environment (NUREG/CR-6751, ``The Human Performance
Evaluation Process: A Resource for Reviewing the Identification and
Resolution of Human Performance Problems'') as well as failures to act
(i.e., errors of omission). Therefore, testing would be required
regardless of whether there was ``reasonable suspicion'' that the
individual was abusing drugs or alcohol for the consequences listed in
the proposed paragraph.
In addition, the second sentence of proposed Sec. 26.31(c)(3)
would be added in response to stakeholder comments at the public
meetings discussed in Section V. The stakeholders noted that the
current provision does not clearly delineate the scope of individuals
who must be subject to post-event testing. Some licensees have
misinterpreted the current provision as requiring that all individuals
who are involved in a significant event must be tested, including
individuals whose behavior played no causal or contributing role in the
event. For example, these licensees' FFD programs would require that an
individual who was exposed to radiation in excess of regulatory limits
must be tested, even if other individuals' actions (or failures to act)
were responsible for the event and the individual who suffered the
exposure was a bystander. Therefore, the second sentence of the
proposed provision would clarify the original intent of this paragraph
by stating that only the individual(s) who committed the error(s) would
be subject to post-event testing.
Proposed Sec. 26.31(c)(3)(i) would provide a threshold for the
types of workplace personal injuries and illnesses for which post-event
testing would be required in response to implementation questions
related to current Sec. 26.24(a)(3). Some licensees have
misinterpreted the current provision as requiring post-event testing
for any personal injury, no matter how minor. The proposed paragraph
would clarify the type of personal injuries and illnesses for which
post-event testing would be required by establishing a threshold that
is based on the general criteria contained in 29 CFR 1904.7 of the
regulations of the Occupational Safety and Health Administration (OSHA)
for recording occupational injuries and illnesses. As defined in the
OSHA standard and the proposed rule, these would include any injuries
and illnesses which result in death, days away from work, restricted
work, transfer to another job, medical treatment beyond first aid, loss
of consciousness, or other significant injury or illness as diagnosed
by a physician or other licensed health care professional, even if it
does not result in death, days away from work, restricted work or job
transfer, medical treatment beyond first aid, or loss of consciousness.
The proposed rule would add this clarification to reduce the number of
unnecessary post-event tests performed for minor injuries and illnesses
and meet Goal 3 of this rulemaking, which is to improve the
effectiveness and efficiency of FFD programs.
In response to stakeholder comments at the public meetings
discussed in Section V, proposed Sec. 26.31(c)(3)(i) would also
include the qualifying phrase, ``within 4 hours after the event,'' with
reference to the recordable personal injuries and illnesses that would
trigger post-event testing. The stakeholders noted that, in some cases,
it is difficult to detect illnesses and injuries that meet the proposed
threshold for post-event testing at the time they occur. For example,
if an individual has been injured on site but does not report the
injury to the licensee or other entity and waits for several days to
seek treatment from his or her private physician, the licensee or other
entity may not learn of the injury. The extent of an injury may be
unclear at the time it occurs and so it may appear to fall below the
threshold for post-event testing until several days have passed. In
these examples, if the licensee or other entity learns after several
days that the injury would have met the threshold for post-event
testing, it would be too late for post-event testing to be of any value
in determining whether the individual's use of drugs or alcohol may
have contributed to the event. If alcohol
[[Page 50490]]
or drug use had contributed to the event, testing several days later
would be unlikely to detect it because of the effects of metabolism.
Further, it would be difficult to prove that any non-negative test
results reflected the individual's condition at the time the event
occurred rather than subsequent drug or alcohol use. Therefore, the
proposed rule would limit post-event testing to situations in which the
licensee or other entity can determine that an injury or illness meets
the proposed threshold within 4 hours after the event has occurred, and
can conduct the testing within a time frame that will provide useful
information about the individual's condition at the time of the event.
However, the proposed paragraph should not be misinterpreted as
requiring post-event testing to be completed within 4 hours after the
event. The time period after the event within which testing must be
completed would be defined in proposed Sec. 26.31(c)(3) as ``as soon
as practical.'' This proposed change would be made to meet Goal 3 of
this rulemaking, which is to improve the effectiveness and efficiency
of FFD programs.
Proposed Sec. 26.31(c)(3)(ii) would carry over the relevant
language in the corresponding portion of current Sec. 26.24(a)(3),
without change.
Proposed Sec. 26.31(c)(3)(iii) would carry over the relevant
language in the corresponding portion of current Sec. 26.24(a)(3),
but, as discussed with respect to proposed Sec. 26.31(c)(3), would
eliminate the current qualifying phrase, ``if there is reasonable
suspicion that the worker's behavior contributed to the event.''
Proposed Sec. 26.31(c)(4) [Followup] would retain the intent of
current Sec. 26.24(a)(4) but amend its language. The proposed rule
would eliminate the phrase, ``to verify continued abstention from the
use of substances covered under this part,'' because it could be
misinterpreted as limiting the substances for which followup testing
would be permitted to only those listed in proposed Sec. 26.31(d)(1)
[Substances tested]. The proposed rule would revise this phrase as,
``to verify continued abstinence from substance abuse,'' to clarify
that FFD programs would be permitted to conduct followup testing for
any substances an individual may have abused, subject to certain
additional requirements discussed with respect to proposed Sec.
26.31(d)(1)(i). Detailed requirements for conducting followup testing
would be established in proposed Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information], where they
would apply to licensees' and other entities' processes for granting
and maintaining authorization. The proposed rule would make these
changes to meet Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule.
Proposed Sec. 26.31(c)(5) [Random] would simplify current Sec.
26.24(a)(2) to define random testing as one of the conditions under
which testing is required. The detailed requirements for implementing
random testing that are contained in current Sec. 26.24(a)(2) would be
moved to proposed Sec. 26.31(d) [General requirements for drug and
alcohol testing]. The proposed changes would be made to meet Goal 6 of
this rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.31(d) [General requirements for drug and alcohol
testing] would be added to better organize requirements related to the
general administration of drug and alcohol testing. The proposed rule
would present more detailed requirements for conducting drug and
alcohol testing in proposed Subparts E [Collecting Specimens for
Testing], F [Licensee Testing Facilities], and G [Laboratories
Certified by the Department of Health and Human Services]. The proposed
change would be made to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.31(d)(1) [Substances tested] would retain the
list of drugs for which testing must be conducted in current Section
2.1(a) in Appendix A to Part 26, but would clarify that, for some
drugs, the testing is conducted to detect drug metabolites. The
circumstances in which testing for these substances must be performed
(i.e., pre-access, post-event, random) would be moved to proposed Sec.
26.31(c) for organizational clarity. In addition, the proposed
paragraph would add adulterants to the list of substances for which
testing must be conducted, consistent with the addition of specimen
validity testing requirements to the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.31(d)(1)(i) would retain the permission in the
second sentence of current Sec. 26.24(c) for licensees and other
entities to consult with local law enforcement agencies or other
sources of information to identify drugs that may be abused by
individuals in the geographical locale of the FFD program.
Proposed Sec. 26.31(d)(1)(i)(A) would retain the permission in
current Sec. 26.24(c) for licensees and other entities to add to the
panel of drugs for which testing is required in proposed Sec.
26.31(d)(1). Additional drugs may include, but are not limited to,
``designer drugs,'' such as ecstasy or ketamine, and illegal drugs that
are popular in some geographical areas, such as lysergic acid
diethylamide-25 (LSD). The proposed paragraph would also require that
any additional drugs must be listed on Schedules I-V of section 202 of
the Controlled Substances Act [21 U.S.C. 812], which would be
consistent with the definition of ``illegal drugs'' in current Sec.
26.3 [Definitions].
Proposed Sec. 26.31(d)(1)(i)(B) would retain the last sentence in
current Sec. 26.24(c), which requires licensees and other entities who
are subject to the rule to establish appropriate cutoff levels for any
additional substances for which testing will be conducted.
Proposed Sec. 26.31(d)(1)(i)(C) would retain the requirement in
current Section 2.1(c) in Appendix A to Part 26, which requires
licensees and other entities to establish rigorous testing procedures
for any additional drugs.
Proposed Sec. 26.31(d)(1)(i)(D) would be added to further clarify
the requirement in proposed Sec. 26.31(d)(1)(i)(C) for ``rigorous
testing procedures'' and would replace the portion of current Section
1.1(2) in Appendix A to Part 26 that requires licensees to obtain
written approval from the NRC to test for additional drugs. The purpose
of the current requirement is to provide an opportunity for the NRC to
verify that the assays and cutoff levels licensees use in testing for
additional drugs are scientifically sound and legally defensible.
However, the current requirement also imposes a reporting burden. The
proposed provision would eliminate this reporting requirement and
replace it with requirements for an independent forensic toxicologist
to conduct the review that the NRC currently performs. The proposed
rule would require the independent forensic toxicologist to certify, in
advance and in writing, that the assay to be used in testing for any
additional drugs or drug metabolites, and the cutoff levels to be
applied, are scientifically sound and legally defensible. The proposed
paragraph would also specify the required qualifications for the
forensic toxicologist. Certification of the assay and cutoff levels
would not be required in two circumstances: (1) If the HHS Guidelines
are revised to permit use of the assay and the cutoff levels in Federal
workplace drug testing programs, and (2) if the licensee or other
entity has received written approval from the NRC to test for the
additional drugs or metabolites and to apply the cutoff levels to be
used in testing for the
[[Page 50491]]
additional drugs or metabolites, as required in current Section 1.1(2)
in Appendix A to Part 26. Certification would be unnecessary in these
two circumstances because it would be redundant. This proposed change
would be made to meet Goal 5 of this rulemaking, which is to improve
Part 26 by eliminating or modifying unnecessary requirements, while
continuing to ensure that any drug testing conducted under Part 26 is
scientifically sound and legally defensible.
Proposed Sec. 26.31(d)(1)(ii) would amend current Section 2.1(b)
in Appendix A to Part 26 and would permit licensees and other entities,
when conducting for-cause, post-event, and followup testing, to test
for any drugs listed on Schedules I-V of the CSA that the licensee or
other entity suspects the individual may have abused, as follows:
The proposed paragraph would add a reference to post-event testing
for consistency with the intent of current Section 2.1(b) in Appendix A
to Part 26, which permits testing for any illegal drugs during a for-
cause test. The current rule includes post-event testing within the
definition of for-cause testing whereas the proposed rule would use a
distinct term, ``post-event'' testing, to refer to the testing that is
required following certain events, as discussed with respect to
proposed Sec. 26.31(d)(3). Therefore, it would be necessary to add a
reference to post-event testing to this paragraph to retain the full
intent of the current provision.
The proposed paragraph would also add a reference to followup
testing, which would permit the licensee or other entity to test for an
additional drug if an individual who is subject to followup testing is
suspected of having abused it. For example, if an SAE, in the course of
performing a determination of fitness under proposed Sec. 26.189
[Determination of fitness], found that an individual was abusing
barbiturates, this provision would permit followup testing to verify
that the individual is abstaining from such abuse. This proposed change
would be made to strengthen the followup testing element of FFD
programs by ensuring that followup testing would detect continued drug
abuse and would therefore, meet Goal 3 of this rulemaking, which is to
improve the effectiveness and efficiency of FFD programs.
The proposed paragraph would retain the limitation in current
Section 2.1(b) in Appendix A to Part 26, which permits testing only for
illegal drugs that the individual is suspected of having abused, and
extend that limitation to followup testing. The proposed rule would
extend this limitation to followup testing to protect donors' rights to
privacy, which is the same reason that the limitation was established
in the current rule with respect to for-cause testing. That is,
licensees and other entities would be prohibited from conducting a wide
spectrum of tests for any drugs without suspicion that the individual
had abused them, because such tests could reveal personal medical
information about the individual that is irrelevant to the performance
objectives of this part, as discussed with respect to Sec. 26.23
[Performance objectives]. Thus, extending the current limitation on
for-cause testing to followup testing would meet Goal 7 of this
rulemaking, which is to protect the privacy and due process rights of
individuals who are subject to Part 26.
The proposed paragraph would replace the term, ``illegal drugs,''
in current Section 2.1(b) in Appendix A to Part 26 with a specific
reference to the drugs that are listed on Schedules I-V of the CSA.
These schedules list drugs with abuse potential and include many drugs
with legitimate medical uses that are not ``illegal'' when used in
accordance with a valid prescription for medical purposes. Therefore,
replacing the term, ``illegal drugs,'' with the reference to Schedules
I-V of the CSA would more accurately characterize the specific drugs
for which testing is permitted. This proposed change would be made to
meet Goal 6 of this rulemaking, which is to improve clarity in the
language of the rule.
Proposed Sec. 26.31(d)(1)(ii) would also apply the new
requirements in proposed Sec. 26.31(d)(1)(i)(D) related to testing for
drugs that are not included in the FFD program's panel of drugs to for-
cause, post-event, and followup testing. The proposed paragraph would
require the assays and cutoff levels to be used in testing for the
additional drugs to be certified by a forensic toxicologist in
accordance with proposed Sec. 26.31(d)(1)(i)(D). The proposed
provision would provide consistency with proposed Sec.
26.31(d)(1)(i)(D) and ensure that the testing would be scientifically
sound and legally defensible. The proposed change would be made to
protect donors' rights to due process, as it relates to minimizing the
possibility of false positive test results, and strengthen the
effectiveness of FFD programs by ensuring that tests for additional
drugs that are conducted for cause, post-event, or as part of a
followup program will accurately detect drugs that an individual may
have abused. Therefore, this proposed change would be made to meet Goal
7 of this rulemaking, which is to protect the privacy and due process
rights of individuals who are subject to Part 26, and Goal 3, which is
to improve the effectiveness and efficiency of FFD programs.
The last sentence of proposed Sec. 26.31(d)(1)(ii) would be added
to prohibit inappropriate practices that some FFD programs have
implemented. The NRC is aware that some FFD programs have directed
their HHS-certified laboratories to test specimens that are collected
for for-cause, post-event, or followup testing at the assay's LOD
without first subjecting the specimens to initial testing. In addition,
if a drug or drug metabolite is detected at the LOD, the MROs in these
programs have confirmed the test result as an FFD policy violation,
despite the quantitative test result falling below the FFD program's
established confirmatory cutoff level. Although these practices may
increase the likelihood of detecting drug abuse, they are inconsistent
with one of the bases for establishing cutoff levels for drug testing
in the rule, which is to minimize the likelihood of false positives
that could result in the imposition of sanctions on an individual who
has not abused drugs. It also subjects individuals who are undergoing
for-cause, post-event, or followup testing to unequal treatment when
compared to individuals who are subject to random and pre-access
testing, in which the established cutoff levels must be applied.
Therefore, the proposed rule would specifically prohibit these
practices to meet Goal 7 of this rulemaking, which is to protect the
privacy and due process rights of individuals who are subject to Part
26, by requiring that individuals who are subject to for-cause, post-
event, and followup testing must be subject to the same testing
procedures and cutoff levels as others who are tested under this part.
Proposed Sec. 26.31(d)(2) [Random testing] would reorganize and
amend the requirements for conducting random testing, which currently
appear in Sec. 26.24(a)(2), as follows:
Proposed Sec. 26.31(d)(2)(i) would add a new requirement for
licensees and other entities to administer random testing in a manner
that provides reasonable assurance that individuals are unable to
predict the time periods during which specimens will be collected. This
proposed provision would be added because the NRC is aware of instances
in which individuals who believed they would have a non-negative
result, if tested, have been able to determine the
[[Page 50492]]
days on which collections were being conducted, which then gave them
the opportunity to leave work under the guise of illness in order to
avoid the possibility of being tested. The ability to detect that
specimens are or will be collected for random testing also provides an
opportunity for individuals to be prepared to subvert the testing by
procuring an adulterant or urine substitute and keeping it available on
their persons during the periods that specimens are collected. However,
the NRC also recognizes that it is impossible to ensure that
individuals are unable to detect the periods during which specimens are
being collected. At a minimum, coworkers will be suspicious that
collections are occurring if they observe an individual leaving the
work site and returning within a short time, even if the supervisor and
individual do not discuss the reason for the individual's short
absence. Therefore, the proposed paragraph would require licensees and
other entities to conduct random testing in a manner that would provide
``reasonable assurance'' that individuals are unable to predict when
specimens will be collected, rather than requiring them to ``ensure''
that the period of time during which specimens will be collected cannot
be detected. However, licensees and other entities would be required to
minimize the likelihood that individuals who are subject to testing
know that they are more likely to be called for testing at certain
times than others.
Within this context, proposed Sec. 26.31(d)(2)(i)(A) would be
added to require licensees and other entities to take reasonable steps
to either conceal from the workforce that collections will be performed
during a scheduled collection period, or create the appearance that
specimens are being collected during a portion of each day on at least
four days in each calendar week at each site. This proposed provision
would require licensees and other entities to take reasonable steps to
minimize the cues that persons may use to detect that specimens will be
collected at a certain time. These cues may include, but are not
limited to, the presence of a mobile collection facility on site and
the presence of collectors at the site only on days that collections
occur, or having the lights on in a designated collection site and
occupying it only when the collection site is in use. A reasonable step
to minimize cues associated with activities inside a collection site
could be covering any outside windows so that a passerby cannot detect
whether the collection site is occupied. Other steps to meet the
proposed requirement could include, but would not be limited to,
stationing a mobile collection facility on site for some part of the
day on four days each week or assigning individuals to staff the
designated collection site during periods that specimens are not being
collected during some portion of each day on at least four days in each
calendar week. Maintaining the appearance that the collection site is
active on more than half of the days in each week would make it more
difficult for individuals to plan to subvert the testing process by
leaving work when they believe specimens are being collected. The
requirements in proposed Sec. 26.31(d)(2)(i) and (A) would be added to
meet Goal 3 of this rulemaking, which is to improve the effectiveness
of FFD programs, by reducing the opportunities for individuals to
subvert the testing process by having advanced warning that specimens
are being collected.
Proposed Sec. 26.31(d)(2)(i)(B) would amend the third sentence of
current Sec. 26.24(a)(2), which requires that specimens must be
collected ``at various times during the day.'' The proposed rule would
expand the current requirement to require licensees and other entities
to ``collect specimens on an unpredictable schedule, including
weekends, backshifts, and holidays, and at various times during a
shift.'' The purpose of the current and proposed provisions is to
ensure that individuals cannot predict the times at which they will be
tested, as well as prevent them from perceiving that there are ``safe''
periods during which they will not be tested that may lead them to
believe they could engage in substance abuse without fear of detection.
Varying the time periods during which specimens are collected on an
unpredictable schedule would also increase the rule's effectiveness in
deterring substance abuse. Adding this proposed provision would meet
Goal 3 of this rulemaking, which is to improve the effectiveness of FFD
programs.
Proposed Sec. 26.31(d)(2)(ii) would retain the third sentence of
current Sec. 26.24(a)(2), which states that random testing must be
administered on a nominal weekly frequency. The current requirement to
collect specimens for random testing at ``various times during the
day'' would be retained in proposed Sec. 26.31(d)(2)(i)(B).
Proposed Sec. 26.31(d)(2)(iii) would require individuals who are
selected for random testing to report to the collection site as soon as
reasonably practicable after they have been notified that they have
been selected for testing, within the time period established in the
FFD policy. The necessity for the FFD policy to establish a time limit
within which individuals must report for testing is discussed with
respect to proposed Sec. 26.27(b)(2). Proposed Sec. 26.31(d)(2)(iii)
would be added to further clarify this requirement by emphasizing the
individual's responsibility to report as soon as reasonably practicable
after notification. For example, in order to cover all of the possible
situations in which it may not be possible for an individual to
immediately report for testing after notification (which could include
the time required to travel to a collection site or to change clothes
and be monitored for contamination after working under a radiation work
permit), the FFD policy may permit individuals up to 2 hours to report
for testing after notification. However, if there are no legitimate
work, travel, or other demands that prevent an individual from
immediately reporting for testing, the proposed provision would require
the individual to report as soon as he or she is notified. This
provision would strengthen FFD programs by further reducing
opportunities for individuals to subvert the testing process, as
discussed with respect to proposed Sec. 26.27(b)(2), and, therefore,
would meet Goal 3 of this rulemaking, which is to improve the
effectiveness of FFD programs.
Proposed Sec. 26.31(d)(2)(iv) would amend the first sentence of
current Sec. 26.24(a)(2) to clarify that individuals who are off site
and unavailable for testing when selected for a random test, must be
tested at the earliest reasonable and practical opportunity. This
proposed requirement would be added to prohibit licensees and other
entities from returning these individuals' names to the random testing
pool without conducting a test, as has been some licensees' practice.
Returning the individuals' names to the random testing pool without
conducting a test ensures that they are immediately eligible for
another unannounced test, as required in proposed Sec. 26.31(d)(2)(v),
but does not ensure that all individuals who are subject to this part
have an equal probability of being tested. This proposed revision,
therefore, would meet Goal 3 of this rulemaking, which is to improve
the effectiveness of FFD programs.
The proposed paragraph would include the phrase, ``at the earliest
reasonable and practical opportunity when both the donor and collectors
are available to collect specimens for testing,'' to clarify that
licensees and other entities would not be required to call an
individual back to the site if he
[[Page 50493]]
or she is off site when selected for testing. In addition, the proposed
provision would not require licensees and other entities to make
special arrangements to ensure that a collector is available to collect
the specimens as soon as the individual returns to the site. The NRC is
aware that some licensees have called in individuals and collectors in
the past under these circumstances. However, these practices may permit
individuals to predict that they will be subject to testing when they
return to the site, which would provide them with an opportunity to
take actions to subvert the testing process, as discussed with respect
to proposed Sec. 26.31(d)(2)(i). Therefore, the proposed paragraph
would require licensees and other entities to collect specimens from an
individual who is off site when selected for testing, in a manner that
also ensures the individual does not have advance notification that he
or she has been selected for testing. This proposed change would be
made to meet Goal 3 of this rulemaking, which is to improve the
effectiveness and efficiency of FFD programs.
Proposed Sec. 26.31(d)(2)(v) would retain the second sentence of
Sec. 26.24(a)(2), which requires that an individual who has completed
a test is immediately eligible for another random test.
Proposed Sec. 26.31(d)(2)(vi) would amend the last sentence of
current Sec. 26.24(a)(2) in response to licensee implementation
questions with respect to the meaning of the term, ``workforce,'' in
the current rule. These questions have related to whether ``workforce''
means all individuals who are employed by the licensee, including
individuals who are not subject to Part 26, all individuals at a site,
or all individuals who are subject to the licensee's FFD program. The
proposed paragraph would clarify that the number of random tests that
must be performed in a year must be equal to 50 percent of the
population of individuals who are subject to random testing under the
FFD program. If several sites are covered by a common FFD program, the
``population'' would include all individuals who are subject to the
common FFD program. The population would also include individuals who
have applied for authorization and who are subject to random testing
under proposed Sec. 26.67 [Random drug and alcohol testing of
individuals who have applied for authorization]. This proposed change
would be made to meet Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule.
Proposed Sec. 26.31(d)(3) [Drug testing] would be added to group
requirements in one paragraph that are related to the general
administration of drug testing. This proposed change would be made
because requirements that address this topic are dispersed throughout
the current rule whereas grouping them together in a paragraph would
make them easier to locate within the proposed rule. The proposed
reorganization would meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.31(d)(3)(i) would combine some of the
requirements in current Section 1.1(3) in Appendix A to Part 26, Sec.
26.24(f), the first sentence of current Section 2.8(e)(1) in Appendix
A, and current Section 4.1(a) and (b) in Appendix A to Part 26, which
require licensees and other entities to use only HHS-certified
laboratories to perform drug testing, except if initial tests are
performed at a licensee testing facility. Other detailed requirements
in these sections would be retained, but presented in the appropriate
sections in proposed Subparts E [Collecting specimens for testing], F
[Licensee Testing Facilities], and G [Laboratories Certified by the
Department of Health and Human Services]. The proposed rule would use
the term, ``non-negative,'' to replace the term, ``presumptive
positive,'' in this paragraph and throughout the remainder of the rule
to refer collectively to adverse validity and drug test results, as
discussed with respect to the definition of ``non-negative'' in
proposed Sec. 26.5 [Definitions]. These proposed changes would be made
to meet Goal 6 of this rulemaking, which is to improve the
organizational clarity of the rule.
The proposed paragraph would also require that specimens sent to
the HHS-certified laboratory by the licensee or other entity must be
subject to initial validity and drug testing by the laboratory, and any
specimens that yield non-negative initial validity or drug test results
must be subject to confirmatory testing by the laboratory, except for
invalid specimens that cannot be tested. Specimen validity testing
refers to testing conducted by a laboratory to identify attempts to
tamper with a specimen. Attempts to tamper with a specimen may include
(1) adulteration, which means putting a substance into a specimen that
is designed to mask or destroy the drug or drug metabolite that the
specimen may contain or to adversely affect the assay reagent; (2)
dilution, which means adding a liquid, which, by contrast to an
adulterant, would not be detected by validity testing, to the urine
specimen to decrease the concentration of a drug or metabolite below
the cutoff concentration; and (3) substitution, which means replacing a
valid urine specimen with a drug-free specimen. When HHS published its
Notice of Proposed Revisions (66 FR 43876; August 21, 2001) to the HHS
Guidelines to establish requirements for specimen validity testing
performed by HHS-certified laboratories, the HHS reported that the
number of adulterated and substituted urine specimens has been
increasing among the specimens tested under the Federal agency
workplace drug testing program and the U.S. Department of
Transportation (DOT) regulations (49 CFR part 40). Program experience
gained since Part 26 was first promulgated has also indicated an
increasing number of adulterated and substituted urine specimens
submitted to HHS-certified laboratories from Part 26 testing programs.
Although current Part 26 contains a number of requirements related to
specimen validity (e.g., the fifth sentence of current Section 2.1(e),
Section 2.4(f)(2), 2.4(g)(14)-(g)(16), and 2.7(d) in Appendix A to Part
26), the methods available to tamper with specimens have become more
sophisticated since the rule was first published and more sophisticated
methods of detecting tampering are necessary. Therefore, the proposed
rule would incorporate new requirements for HHS-certified laboratories
to conduct specimen validity tests that are consistent with similar
provisions contained in the most recent revision to the HHS Guidelines
(69FR 19643; April 13, 2004). These new requirements for specimen
validity testing would be added to strengthen FFD programs by improving
current laboratory procedures to detect specimens that are dilute,
adulterated, or substituted, consistent with Goal 1 of this rulemaking,
which is to update and enhance the consistency of Part 26 with advances
in other relevant Federal rules and guidelines. Detecting specimen
tampering is necessary to identify individuals who may attempt to hide
drug abuse, because attempts to tamper with a specimen provide clear
evidence that the individual is not trustworthy and reliable, and
because these individuals' drug use may pose a risk to public health
and safety and the common defense and security, as discussed with
respect to proposed Sec. 26.23 [Performance objectives].
Proposed Sec. 26.31(d)(3)(ii) would amend the first sentence of
current Sec. 26.24(d)(1), which permits licensees and other entities
to conduct initial testing of urine specimens at a licensee
[[Page 50494]]
testing facility, provided that the licensee testing facility staff
possesses the necessary training and skills for the tasks assigned, the
staff's qualifications are documented, and adequate quality controls
for the testing are implemented. The proposed rule would add permission
for licensees and other entities to perform initial validity testing at
a licensee testing facility, for the reasons discussed with respect to
proposed Sec. 26.31(d)(3)(i). Detailed requirements related to
specimen validity testing at licensee testing facilities would be
established in proposed Subpart F [Licensee Testing Facilities].
Proposed Sec. 26.31(d)(3)(iii) would be based upon the portions of
current Sections 2.7(e)(1) and 2.7(f)(2) in Appendix A to Part 26 that
establish the cutoff levels for initial and confirmatory drug testing,
respectively, which licensees must apply under the current rule.
However, the proposed paragraph would require FFD programs to apply the
updated cutoff levels specified in proposed Sec. 26.163(a)(1) for
initial drug testing and proposed Sec. 26.163(b)(1) for confirmatory
drug testing. Consistent with the first sentence of current Sec.
26.24(b), the proposed paragraph would also permit FFD programs to
implement more stringent cutoff levels than specified in the rule, but
would establish additional requirements related to lower cutoff levels,
as will be discussed further below. The permission in the first
sentence of current Sec. 26.24(b) to implement a broader panel of
drugs would be relocated to proposed Sec. 26.31(d)(1), as discussed
with respect to that paragraph.
Proposed Sec. 26.31(d)(3)(iii)(A) would retain the third and
fourth sentences of current Sec. 26.24(b) regarding management actions
and sanctions for confirmed positive drug test results based on any
lower cutoff levels established by the FFD program. The proposed rule
would add a requirement that the lower cutoff levels must be documented
in the FFD program's written policy and procedures to ensure that
individuals who are subject to testing are aware of the cutoff levels
that would be applied to their drug test results in order to protect
their rights to due process. The proposed change would be made to meet
Goal 7 of this rulemaking, which is to protect the due process rights
of individuals who are subject to Part 26.
Proposed Sec. 26.31(d)(3)(iii)(B) would require that the FFD
program's cutoff levels for drugs and drug metabolites, including any
more stringent cutoff levels, must be uniformly applied in all tests
conducted under this part and equally to all individuals who are
subject to testing, except as permitted under proposed Sec.
26.163(a)(2) for dilute specimens and proposed Sec. 26.165(c)(2) for
retesting specimens. As discussed with respect to proposed Sec.
26.31(d)(1)(ii), some FFD programs have adopted the practice of testing
specimens at the assay's LOD for for-cause, post-event, and followup
tests, which results in some individuals receiving unequal treatment
under the rule. Therefore, the proposed paragraph would be added to
meet Goal 7 of this rulemaking, which is to protect the privacy and due
process rights of individuals who are subject to Part 26.
Proposed Sec. 26.31(d)(3)(iii)(C) would be added to specify
requirements for establishing more stringent cutoff levels. Before
implementing the more stringent cutoff levels, licensees and other
entities who are subject to the rule would be required to obtain
certification from an independent forensic toxicologist that the more
stringent cutoff levels are technically sound and legally defensible,
with two exceptions. Certification by a forensic toxicologist would not
be required if: (1) The U.S. Department of Health and Human Services
lowers the cutoff levels in the HHS Guidelines for the same drugs or
drug metabolites and the FFD program adopts the lower HHS cutoffs or
(2) the licensee or other entity previously received written approval
from the NRC to apply lower cutoff levels, in accordance with current
Section 1.1(2) in Appendix A to Part 26. These proposed requirements
would be consistent with those contained in proposed Sec.
26.31(d)(1)(i)(D) related to adding drugs to the panel of drugs for
which testing is required under the rule and would be added here for
the same reasons discussed with respect to that paragraph. Licensees
and other entities would no longer be required to inform the NRC, in
writing, that they have implemented new, lower cutoff levels because
the purpose of the reporting would be met by the forensic
toxicologist's review. Therefore, these changes would be made to meet
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating
or modifying unnecessary requirements, while continuing to protect
donors' right to accurate and reliable drug testing.
Proposed Sec. 26.31(d)(4) [Alcohol testing] would update current
Sec. 26.24(g), which contains general requirements for conducting
alcohol testing, to reflect other changes that would be made in the
proposed rule. The current cross-reference to Section 2.7(o)(3) in
Appendix A to Part 26 would be amended to refer to Sec. 26.91(a) in
Subpart E [Collecting Specimens for Testing], which would contain
detailed requirements for conducting alcohol testing. Reference to oral
fluids as acceptable specimens for initial alcohol testing would be
added to this paragraph. The basis for adding oral fluids as acceptable
specimens for initial alcohol testing is discussed with respect to
proposed Sec. 26.83 [Specimens to be collected]. The BAC at which a
confirmatory test is required would be changed to 0.02 percent (from
0.04 percent) in the proposed paragraph for consistency with the
revised alcohol cutoff levels in proposed Sec. 26.99 [Determining the
need for a confirmatory test for alcohol] and proposed Sec. 26.103
[Determining a confirmed positive test result for alcohol]. The basis
for the revised alcohol cutoff levels is discussed with respect to
those sections. Reference to blood testing for alcohol would be deleted
because donors would no longer be permitted to request blood testing
for alcohol in the proposed rule, as discussed with respect to proposed
Sec. 26.83(a).
Proposed Sec. 26.31(d)(5) [Medical conditions] would be added to
address circumstances in which it may be impossible or inadvisable to
test an individual using the procedures specified in this part.
Circumstances have arisen under Part 26, as well as the programs of
other Federal agencies, in which an individual's medical condition has
made it inadvisable to implement testing procedures in accordance with
the relevant requirements. Therefore, proposed Sec. 26.31(d)(5)(i)
would permit alternative specimen collection and evaluation procedures
for rare instances in which it would be difficult or hazardous to the
donor to collect breath, oral fluids, or urine specimens, including,
but not limited to, required post-event testing when an individual has
been seriously injured. Only the MRO would be permitted to authorize an
alternative evaluation procedure, which may include, but is not limited
to blood testing for alcohol. Proposed Sec. 26.31(d)(5)(ii) would be
added to clarify that necessary medical treatment may not be delayed in
order to conduct drug and alcohol testing. These proposed paragraphs
would be consistent with the requirements of other Federal agencies and
meet Goal 1 of this rulemaking, which is to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
Proposed Sec. 26.31(d)(6) [Limitations of testing] would retain
and amend current
[[Page 50495]]
Section 2.1(d) in Appendix A to Part 26, which states that specimens
collected under Part 26 may only be designated or approved for testing
as described in this part and may not be used for any other analysis or
test without the permission of the tested individual. The proposed
paragraph would add examples of the types of analyses and tests that
would be prohibited without the donor's written permission. Although
the NRC is not aware of any instances in which such unauthorized
testing has occurred in FFD programs under this part, the technology
for performing these analyses and tests has become increasingly
available since the regulation was first promulgated. These examples
would be added to meet Goal 7 of this rulemaking, which is to protect
the privacy and due process rights of individuals who are subject to
Part 26.
Section 26.33 Behavioral Observation
Proposed Sec. 26.33 [Behavioral observation] would be added to
emphasize that behavioral observation is a required element of FFD
programs. The first sentence of proposed Sec. 26.33 would require
behavioral observation of individuals who are subject to this part. The
second sentence would retain current Sec. 26.22(a)(3), (a)(4), and
(b), which state that the individuals who perform behavioral
observation must be trained to do so, and extend the training
requirement to all individuals who are subject to Part 26. The third
sentence of the proposed paragraph would require that individuals must
report FFD concerns arising from behavioral observation to the
appropriate personnel designated in the FFD program procedures. These
proposed changes would be made to strengthen the behavioral observation
element of FFD programs by increasing the likelihood that impairment
and other adverse behaviors are detected and appropriately addressed by
the licensees and other entities who are subject to the rule.
Section 26.35 Employee Assistance Programs
Proposed Sec. 26.35 [Employee assistance programs] would amend
current Sec. 26.25 [Employee assistance programs (EAP)] for the
reasons discussed with respect to each paragraph that would be added to
the proposed rule. Proposed Sec. 26.35(a) would retain the current
provision.
In response to implementation questions, proposed Sec. 26.35(b)
would be added to clarify that licensees and other entities are not
required to provide EAP services to C/V employees who are working at a
licensee's or other entity's facility and are subject to this part.
This proposed provision would be consistent with the interpretation of
the current rule in item 13.1.4 of NUREG-1354. However, the proposed
rule would continue to require that C/V employees who are subject to
Part 26 must have access to an EAP, and licensees and other entities
who rely upon the C/V's FFD program would continue to be required to
ensure that the C/V's EAP meets the requirements of this part. The
proposed paragraph would be added to meet Goal 6 of this rulemaking,
which is to improve clarity in the organization and language of the
rule.
The proposed paragraph would also state that licensees and other
entities need not provide EAP services to individuals who have applied
for authorization to perform job duties that would require them to be
subject to this part. Licensees and other entities would not be
required to provide an EAP to applicants for authorization because
these individuals would not yet be performing job duties that could
affect public health and safety or the common defense and security.
This proposed clarification would be added because applicants would be
subject to other requirements under the proposed rule, as discussed
with respect to proposed Sec. 26.25(d).
Proposed Sec. 26.35(c) would amend the last sentence of current
Sec. 26.25 to emphasize that the identity and privacy of an individual
who seeks EAP services must be protected and clarify the conditions
under which an individual's confidentiality may or must be violated by
EAP personnel. The proposed rule would permit EAP personnel to
communicate information about an individual by name to the licensee or
other entity under only two conditions: (1) If the individual waives
the right to privacy, or (2) EAP personnel determine that the
individual's condition or actions pose or have posed an immediate
threat to himself or herself or others. The proposed provision would
clarify the NRC's intent with respect to EAP confidentiality because
the current provision has been misinterpreted.
The last sentence of current Sec. 26.25 requires confidentiality
for individuals who seek EAP services, except if EAP professionals
determine that the individual's condition ``constitutes a hazard to
himself or herself or others.'' Some licensees have over-interpreted
this phrase and routinely require EAP staff to report individuals who
self-refer for any reason, which is not the intent of this provision.
The NRC is also aware that this phrase has been misinterpreted by some
individuals who are subject to the rule as meaning that no self-
referral to the EAP would remain confidential and that EAP staff always
report self-referrals to licensee management. This perception appears
to be widely shared, including by individuals who are subject to FFD
programs that have not misinterpreted the current rule and who
correctly permit EAP staff to make the determination whether an
individual's condition should be reported to licensee management.
A key purpose of requiring EAPs under Part 26 is to encourage
individuals and their family members to self-refer for any type of
problem that could potentially impair job performance, so that early
intervention may be offered to prevent the problem from adversely
affecting the individuals' job performance. Upon assessment, it is not
uncommon for EAP staff to find that a developing substance abuse
problem is contributing to a financial or family problem for which an
individual has sought assistance. As a result, the EAP provides an
important means to detect and achieve early resolution of developing
substance abuse and other problems, which, if left untreated, could
have the potential to adversely affect an individual's ability to
safely and competently perform his or her job duties. The knowledge or
perception among individuals who are subject to the rule that self-
referrals to the EAP will be reported to management and will routinely
result in the loss of authorization represents a significant barrier to
the effectiveness of the EAP element of FFD programs. Therefore, the
proposed paragraph would amend the last sentence of current Sec. 26.25
to clarify that an individual's use of the licensee's or other entity's
EAP must remain confidential, except in very limited circumstances.
Proposed Sec. 26.35(c)(1) would be added to prohibit licensees and
other entities from requiring the EAP to routinely report the names of
individuals who self-refer to the EAP and the nature of the problems
that led to the self-referral. The proposed provision would be
necessary to: (1) Eliminate some licensees' practices of requiring
these reports, (2) protect individuals' privacy, and (3) strengthen the
EAP element of FFD programs by eliminating a current barrier to self-
referrals in some FFD programs. The term, ``routinely,'' would be used
to indicate that the proposed rule would permit EAP personnel to report
individuals' names and the nature of their problems if the individuals
have waived the right to privacy in writing or EAP personnel determine
that an individual's condition or actions pose or have posed an
immediate risk to public
[[Page 50496]]
health and safety or the common defense and security. The proposed
provision would not prohibit EAPs from reporting program utilization
statistics or aggregated data that characterize the types of problems
for which the program has provided services, because this type of
information would not compromise individuals' privacy.
Proposed Sec. 26.35(c)(2) would be added to provide further
clarity in the language of the rule with respect to the conditions
under which EAP personnel would be excepted from the confidentiality
requirement in proposed Sec. 26.35(c) and required to report a concern
about an individual to the licensee or other entity. The NRC is
confident that EAP personnel have the qualifications and training
necessary to continue to make the professional judgments required under
the current and proposed rules in these circumstances. However, the
proposed rule would include more detail with respect to the conditions
and actions that an EAP professional would be required to report to
ensure that licensees, other entities, and individuals who are subject
to the rule better understand the intent of the current and proposed
provisions. The proposed rule would require EAP personnel to report a
concern about a specific individual to licensee or other entity
management only when they have substantive reasons to believe that an
individual's condition or actions pose or have posed an immediate
hazard to himself or herself or others. The phrase, ``substantive
reasons to believe,'' would be used to clarify that casual and/or
contextually appropriate comments made by an individual during a
counseling session would not be a sufficient basis for reporting to the
licensee or other entity. For example, an individual's statement that
he or she is concerned about becoming an alcoholic would not constitute
a substantive reason to believe that the individual's condition poses
an immediate hazard. By contrast, this stated concern, in addition to
evidence that the individual's personal relationships, financial
condition, and/or health are suffering from his or her alcohol
consumption, and any indications that the individual has been impaired
while in a work status, would together constitute substantive reasons
to believe that the individual's condition poses an immediate hazard
and must be reported.
Proposed Sec. 26.35(c)(2)(i)-(c)(2)(iii) would be added to provide
several examples of conditions and actions that would require EAP
personnel to provide a report about an individual who has self-referred
to licensee or other entity management. Proposed Sec. 26.35(c)(2)(i)
would require reporting if the EAP staff has substantive reasons to
believe that an individual may harm himself or herself or others,
including, but not limited to, plans threatening suicide, radiological
sabotage, or physical violence against others. Proposed Sec.
26.35(c)(2)(ii) would require reporting if the EAP staff has
substantive reasons to believe that an individual has been impaired
from drugs or alcohol while in a work status and is likely to be
impaired in the future, as discussed with respect to proposed Sec.
26.35(c)(2). Proposed Sec. 26.35(c)(2)(iii) would require reporting if
the EAP staff has substantive reasons to believe that an individual has
committed any of the acts that would require a report to the NRC under
proposed Sec. 26.219(b)(1)-(b)(3), including, but not limited to, the
use, sale, distribution, possession, or presence of illegal drugs, or
the consumption or presence of alcohol within a protected area or while
performing job duties that require the individual to be subject to this
part. The examples included in these proposed paragraphs are
illustrative, but do not represent an exhaustive list of the conditions
and actions that EAP staff may encounter that would be reported to
licensee or other entity management under the proposed rule.
For additional clarity, proposed Sec. 26.35(c)(3) would be added
to cross-reference the provisions in the proposed rule that would
specify the actions that licensees and other entities would take after
receiving a report from EAP personnel that an individual's condition or
actions pose or have posed an immediate hazard to himself or herself or
others. As discussed with respect to those paragraphs, proposed
Sec. Sec. 26.69(d) and 26.77(b) would require the licensee or other
entity to take immediate action to: (1) Prevent the individual from
performing any job duties that require the individual to be subject to
this part; (2) ensure that a determination of fitness is performed by a
professional who has specific qualifications and training to address
the nature of the individual's problem; and (3) either terminate the
individual's authorization or ensure that the condition is resolved
before permitting him or her to return to performing duties under this
part.
These proposed changes to current Sec. 26.25 would be consistent
with Goal 7 of this rulemaking, which is to protect the privacy and due
process rights of individuals who are subject to Part 26, as well as
Goal 3 of this rulemaking, which is to improve the effectiveness and
efficiency of FFD programs.
Section 26.37 Protection of Information
Proposed Sec. 26.37 [Protection of information] would amend
current Sec. 26.29, which contains requirements for protecting the
personal information that must be collected under Part 26. In general,
the proposed section would group requirements related to the protection
of personal information that are dispersed throughout the current rule
to aid in locating these requirements in the proposed rule. The records
retention requirement in current Sec. 26.29(a) would be moved to
proposed Subpart J [Recordkeeping and Reporting Requirements]. These
proposed changes would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization of the rule.
Proposed Sec. 26.37(a) would combine and retain the first sentence
of current Sec. 26.29(a) and the second sentence of current Section
3.1 in Appendix A to Part 26. The proposed paragraph would require
licensees and other entities to establish and maintain a system of
files and procedures to protect the personal information that is
collected under this part and maintain and use such records with the
highest regard for individual privacy.
Proposed Sec. 26.37(b) would amend current Sec. 26.29(b) and
would divide it into several paragraphs for clarity. The first sentence
of the proposed paragraph would amend the first sentence of current
Sec. 26.29(b), which prohibits licensees and other entities from
disclosing personal information collected under this part to any
individuals other than those listed in the sentence. The proposed
paragraph would continue to permit disclosure of the personal
information to the listed individuals and would add permission for the
licensee or entity to disclose the personal information to others if
the licensee or other entity has obtained a signed release for such a
disclosure from the subject individual. The proposed permission to
release the personal information to individuals who are not listed in
the paragraph with the written consent of the subject individual would
be added because some licensees have misinterpreted the current
requirement as prohibiting them from releasing the personal information
under any circumstances, except to the parties listed in this
paragraph. In some instances, such failures to release information have
inappropriately inhibited an individual's ability to obtain information
that was necessary for a review or appeal of the licensee's
determination that the individual had violated the FFD policy.
Therefore, the
[[Page 50497]]
explicit permission for licensees and other entities to release
personal information when an individual consents to the release, in
writing, would be added to meet Goal 7 of this rulemaking, which is to
protect the privacy and due process rights of individuals who are
subject to Part 26.
Proposed Sec. 26.37(b)(1)-(b)(8) would list in separate paragraphs
the individuals to whom licensees and other entities would be permitted
to release personal information about an individual. Proposed Sec.
26.37(b)(3), (b)(4), and (b)(8) would retain unchanged the current
permission for the release of information to NRC representatives,
appropriate law enforcement officials under court order, and other
persons as required by court order. Proposed Sec. 26.37(b)(1), (b)(2),
(b)(5), and (b)(6) would amend the related requirements contained in
current Sec. 26.29(b) to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule. The
specific changes to current Sec. 26.29(b) would include the following:
Proposed Sec. 26.37(b)(1) would retain the current permission for
the release of information to the subject individual and his or her
designated representative. The proposed paragraph would add
requirements for the individual to designate his or her representative
in writing and specify the FFD matters to be disclosed. The proposed
changes would be made in response to implementation questions from
licensees. Licensees have sought guidance from the NRC related to the
manner in which an individual must ``designate'' a representative.
Proposed Sec. 26.37(b)(2) would retain the current permission for
the release of information to the licensee's or other entity's MROs.
The proposed rule would also permit the release of information to MRO
staff members for consistency with proposed Sec. 26.183(d), which
would permit MRO staff to serve some MRO functions under the direction
of the MRO. MRO staff would require access to the personal information
in order to perform their job duties. The role of MRO staff in FFD
programs is further discussed with respect to proposed Sec. 26.183(d).
Proposed Sec. 26.37(b)(5) would amend the current reference to
licensee representatives who have a need to have access to the
information in performing assigned duties. The current rule refers only
to individuals who are performing audits of FFD programs. As a result,
the current rule has been misinterpreted by some licensees as limiting
the release of personal information only to such individuals. This was
not the intent of the provision. Rather, the intent of the current rule
was that licensees and other entities would be permitted to release
information to their representatives who must have access to the
personal information in order to perform assigned job duties.
Therefore, the proposed rule would clarify that licensee
representatives who perform determinations of fitness, such as the SAE
(see the discussion of proposed Sec. 26.187) and human resources
functions, as well as auditors and other representatives of the
licensee or other entity, may be permitted access to personal
information but only to the extent that such access is required to
perform their assigned functions.
Proposed Sec. 26.37(b)(6) and (b)(7) would amend the portion of
current Sec. 26.29(b) that refers to ``persons deciding matters on
review or appeal.'' The proposed changes would be made in response to
implementation questions from licensees, including whether the rule
covers persons deciding matters in judicial proceedings or only the
internal appeals process specified in current Sec. 26.28 [Appeals] as
well as whether information could be released in a judicial proceeding
that was not initiated by the subject individual. The proposed rule
would clarify that the permission includes individuals who are
presiding in a judicial or administrative proceeding, but only if the
proceeding is initiated by the subject individual in proposed Sec.
26.37(b)(6). Proposed Sec. 26.37(b)(7) would be added to cover
``persons deciding matters under review in Sec. 26.39'' [Review
process for fitness-for-duty policy violations], as discussed with
respect to that section.
Proposed Sec. 26.37(c) would be added to require the disclosure of
relevant information to licensees and other entities, including C/Vs,
and their authorized representatives who have a legitimate need for the
information and a signed release from an individual who is seeking
authorization under this part. This proposed provision would be added
to further clarify current Sec. 26.29(b), because some licensees have
misinterpreted the current provision as prohibiting the release of
information to C/Vs who have licensee-approved FFD programs and conduct
suitable inquiries on behalf of licensees and other entities. The
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule.
Proposed Sec. 26.37(d)-(f) would retain several requirements
related to the protection of information in the current rule but move
them into this proposed section for organizational clarity. Proposed
Sec. 26.37(d) would combine requirements in current Sec. 26.29(b) and
Section 3.2 in Appendix A to Part 26, as they relate to an individual's
access to records that are necessary for a review of an FFD policy
violation. The proposed paragraph would retain the current requirements
for licensees, other entities, HHS-certified laboratories, and MROs to
provide the information that an individual requests related to a
determination that the individual has violated the FFD policy on the
basis of drug test results. Proposed Sec. 26.37(e) and (f) would
retain current Section 3.1 in Appendix A to Part 26 and the last
sentence of current Sec. 26.29(b), respectively.
Section 26.39 Review Process for Fitness-for-Duty Policy Violations
Proposed Sec. 26.39 [Review process for fitness-for-duty policy
violations] would amend current Sec. 26.28 [Appeals] and separate it
into several paragraphs. The current section title would be revised to
eliminate the implication that the internal management review is a
legal proceeding. Several requirements would be added to clarify and
strengthen individuals' due process rights during the review, as
follows:
Current Sec. 26.28 requires that individuals who are subject to
the rule have an opportunity for a management review of a determination
that the individual has violated the licensee's or other entity's FFD
policy. Proposed Sec. 26.39(a) would retain the requirement that the
review must be impartial and add a requirement that the review must be
objective. The requirement for an objective review would be added
because some licensees have permitted the same individuals who were
involved in the initial determination that an individual violated the
FFD policy to provide the review that is required under current Sec.
26.28. The impartiality of individuals who are reviewing their own
decisions is questionable, and calls into question the effectiveness of
the review process. Therefore, the proposed requirement for the review
to be both impartial and objective would emphasize the NRC's intent
that the review process must be effective.
In keeping with revisions to several other sections that would be
intended to counter subversion of the testing process, proposed Sec.
26.39(a) would extend this opportunity to request a review to all FFD
violations, including, but not limited to, violations based upon non-
negative validity test results. The proposed paragraph would also
clarify that applicants for authorization must be given the opportunity
for a
[[Page 50498]]
review. Experience with implementing this section of Part 26 has
indicated that some licensees did not provide a review process to
individuals who tested positive on pre-access tests. However, the
factors that could produce false non-negative test results among
licensee and C/V employees (e.g., administrative or testing errors) are
equally likely to occur during pre-access testing of applicants for
authorization. If applicants are not provided with a review process, it
is possible that some of them would be effectively barred from the
industry based on test results erroneously determined to be a violation
of the licensee's or other entity's FFD policy. Providing applicants
with the opportunity to request a review would also enhance program
credibility.
Proposed Sec. 26.39(b) would specify that FFD procedures must
describe the contents and purpose of the notice that licensees and
other entities would be required to provide to an individual who has
violated an FFD policy and state that the individual may submit
additional relevant information as part of the review process. This
proposed clarification is necessary because experience with
implementing current Sec. 26.28 has indicated that, in some cases,
individuals do not understand the purpose of the review process and
their associated rights.
Proposed Sec. 26.39(c) would require that more than one
representative of the licensee's or other entity's management must
conduct the review and that the reviewers may not be anyone who was
involved in the original determination that the individual violated the
FFD policy. These proposed clarifications are necessary because
experience with implementing current Sec. 26.28 has indicated that, in
some instances, the persons who were responsible for the initial
determinations have been conducting reviews. The proposed requirements
that the reviewers may not have been involved in the initial
determination and that more than one management representative must
conduct the review would strengthen the impartiality and objectivity of
the review process in order to further enhance individuals' due process
rights.
Proposed Sec. 26.39(d) would add a requirement that any records
associated with the FFD policy violation must be deleted or corrected,
as appropriate, if the policy violation decision is overturned. This
requirement would be necessary because the proposed rule permits
licensees and other entities to share and rely on information gathered
by other Part 26 programs to a greater extent than currently.
Therefore, incorrect records related to an FFD policy violation could
effectively bar an individual from further employment under a Part 26
program if such information is transmitted to other licensees and
entities who are considering whether to grant authorization to an
individual. The proposed requirement to delete or correct any records
associated with an FFD policy violation that has been overturned would
protect individuals from such potential adverse consequences.
Proposed Sec. 26.39(e) would amend the last sentence of current
Sec. 26.28, which states that licensees and other entities are not
required to provide a review procedure to a C/V's employees and
applicants when the C/V is administering its own drug and alcohol
testing. The proposed rule would amend the current paragraph in
response to implementation questions from licensees who have asked
whether the current provision excuses them from providing a review
process for C/V employees at any time, including situations in which
the FFD policy violation was determined as a result of testing
conducted by the licensee. The proposed rule would revise this sentence
to clarify that the licensee or other entity need not provide a review
process if the FFD violation to be reviewed was identified through the
C/V's drug and alcohol testing program. If the FFD violation was
determined through the licensee's drug and alcohol testing, the
licensee would continue to be required to provide the impartial and
objective review.
Section 26.41 Audits and Corrective Action
Proposed Sec. 26.41 [Audits and corrective action] would rename
and amend current Sec. 26.80 [Audits]. The phrase, ``and corrective
action,'' would be added to the section title to emphasize the NRC's
intent that licensees and other entities must ensure that corrective
actions are taken in response to any adverse findings resulting from an
audit. In addition, the proposed rule would reorganize audit
requirements in current Sec. 26.80, and move several audit and
inspection requirements that are currently addressed in Appendix A to
Part 26 into this section. These proposed changes would be made to meet
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule.
Proposed Sec. 26.41(a) [General] would amend the last sentence in
current Sec. 26.80(a), which states that licensees retain
responsibility for the effectiveness of C/V programs and the
implementation of appropriate corrective action. The proposed paragraph
would revise this requirement to include HHS-certified laboratories as
well as any C/V FFD program elements and FFD programs upon which the
licensee or other entity relies, which is consistent with the original
intent of the current requirement. The proposed change would be to meet
Goal 6 of this rulemaking, which is to improve clarity in the language
of the rule.
Proposed Sec. 26.41(b) [FFD program] would amend the required
audit frequency in current Sec. 26.80(a). (The other requirements
contained in current Sec. 26.80(a) are addressed in other paragraphs
of proposed Sec. 26.41, as discussed with respect to the paragraphs of
the proposed rule that address those topics.) The proposed rule would
decrease the current 12-month FFD program audit frequency to a nominal
24-month frequency, which would grant a petition for rulemaking (PRM-
26-1) submitted by Virginia Power on December 30, 1993. Experience with
implementing Part 26 has shown that annual audits of the entire FFD
program are unnecessary to ensure continued program effectiveness and,
therefore, place an unnecessary burden on those entities who are
subject to the rule. The proposed audit frequency would be decreased to
24 months to relieve this burden and to be consistent with the NRC's
schedule for inspecting FFD programs. The proposed change would be
consistent with Goal 5 of this rulemaking, which is to improve Part 26
by eliminating or modifying unnecessary requirements.
Although the proposed rule would decrease the required audit
frequency, licensees and other entities would be required to monitor
program performance indicators and operating experience, consistent
with a performance-based approach, and audit FFD program elements more
frequently than every 24 months, as needed. In determining the need for
more frequent audits, the proposed rule would require licensees and
other entities to consider the frequency, nature, and severity of
discovered problems, testing errors, personnel or procedural changes,
previous audit findings, and ``lessons learned.'' The proposed change
is intended to promote performance-based rather than compliance-based
audit activities and clarify that programs must be audited following a
significant change in personnel, procedures, or equipment as soon as
reasonably practicable. The NRC recognizes that FFD programs evolve and
new issues and problems continue to arise.
[[Page 50499]]
Turnover of FFD program personnel and contracted services personnel,
such as specimen collectors, exacerbates this concern. Licensee audits
have identified problems that were associated in some way with
personnel changes, such as new personnel not understanding their duties
or procedures, the implications of actions that they took, did not
take, or changes in processes. The purpose of these focused audits
would be to ensure that changes in personnel, procedures, or equipment
do not adversely affect the operation of the particular program element
or function in question. Accordingly, the proposed audit requirement
would ensure that any programmatic problems that may result from
significant changes in personnel, procedures, or equipment are detected
and corrected on a timely basis. This proposed change would be made to
meet Goal 3 of this rulemaking, which is to improve the effectiveness
and efficiency of FFD programs, by requiring more frequent audits of
FFD program elements that may require closer monitoring than a nominal
24-month frequency would provide.
Proposed Sec. 26.41(c) [C/Vs and HHS-certified laboratories] would
amend the audit and inspection requirements for these entities that are
contained in the second sentence of current Sec. 26.80(a) and the
third sentence of Section 2.7(m) in Appendix A to Part 26, as follows:
Proposed Sec. 26.41(c)(1) would further amend the requirement in
current Sec. 26.80(a) for annual audits of C/V FFD programs and
program elements and HHS-certified laboratories. The current annual
audit frequency would be retained only for those portions of C/V FFD
programs whose personnel work off site and are not under the daily
supervision of FFD program personnel. The activities of C/V personnel
who work on site and are under the daily supervision of FFD program
personnel would be audited under proposed Sec. 26.41(b). Retention of
the annual audit requirement for C/Vs whose personnel work off site is
necessary to ensure that the services provided continue to be
effective, given that other means of monitoring their effectiveness,
such as daily oversight, are unavailable. The proposed paragraph would
also retain the annual audit requirement for HHS-certified
laboratories. This audit frequency would be retained because of the key
role the laboratories play in the overall effectiveness of Part 26
programs. Retention of these annual audit requirements in the proposed
paragraph would deny the petition for rulemaking (PRM-26-1) submitted
by Virginia Power on December 30, 1993.
Proposed Sec. 26.41(c)(2) would be added to relax some
requirements related to annual audits and inspections of the HHS-
certified laboratories upon which licensees and other entities rely for
drug testing services. The proposed rule would permit licensees and
other entities who are subject to the rule to rely upon the inspections
of HHS laboratories that are performed for HHS-certification reviews
and would no longer require licensees and other entities to audit the
effectiveness of services that are reviewed by HHS inspectors. The
current rule contains a number of requirements that are inconsistent
with the requirements for drug testing of other Federally mandated
programs. For example, the current rule permits donors to request
confirmatory alcohol testing of a blood specimen at an HHS-certified
laboratory, which is not permitted by other Federal agencies, and some
of the cutoff levels established in the current rule are higher, in the
case of testing for marijuana metabolite, or lower, in the case of
testing for opiates, than other Federal agencies'. These programmatic
discrepancies have made licensee audits of HHS-certified laboratories
necessary to ensure the effectiveness of the unique drug and alcohol
testing services required for Part 26 programs because these services
are not addressed in the HHS inspections. However, as discussed in
Section IV.B, the proposed rule would eliminate the majority of such
discrepancies. Therefore, the annual audits of HHS-certified
laboratories by licensees that have been necessary under the current
rule would be redundant under the proposed rule, except in certain
conditions described below. The proposed change would be made to meet
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating
or modifying unnecessary requirements.
Proposed Sec. 26.41(c)(2) would continue to require licensees and
other entities to conduct annual audits of any services provided to the
licensee or other entity that were not addressed in the annual HHS-
certification review. This annual audit requirement would be retained
because proposed Sec. 26.31(d) would retain the permission in the
current rule for licensees and other entities to establish lower cutoff
levels and test for drugs in addition to those for which testing is
required under this part. If a licensee or other entity chooses to
implement more stringent cutoff levels or a broader panel of drugs than
required in the proposed rule, the licensee or other entity would be
required to ensure that annual audits of the HHS-certified services
related to those cutoff levels and drug tests are performed.
The last sentence of proposed Sec. 26.41(c)(2) would be added in
response to stakeholder comments that were made during the public
meetings discussed in Section V, related to the scope of the current
audit requirements. The stakeholders noted that the scope of the
current audit requirements is ill-defined in the current rule, which
they believe has resulted in unnecessary variability between FFD
programs and also an unnecessary burden. For example, the stakeholders
noted that some FFD programs have interpreted the current rule as
requiring annual audits of any substance abuse treatment program from
which individuals who are subject to their FFD program may seek
services as well as the entire national EAP company with whom the
licensee or other entity contracts to obtain the services of one
individual in the local geographical area. The stakeholders suggested
that such audits are costly and have little relationship to continuing
FFD program effectiveness. The scope of audit requirements was not
specified in the current rule because there is a wide variety of
contractual relationships between licensees, other entities, and C/Vs
for FFD program services that make it impractical to establish limits
that would be universally applicable. However, the examples provided by
the stakeholders at the public meeting were convincing that some
limitations on the scope of the audit requirements would be appropriate
in the proposed rule. Therefore, the proposed rule would not require
licensees and other entities to audit organizations that do not
routinely provide FFD services to the licensee or other entity, such as
local hospitals or a substance abuse treatment facility. It would be
unnecessary to audit these organizations because the FFD program would
use their services infrequently, there would be a reasonable
expectation of quality, and weaknesses in these services could be
identified through other means. For example, under proposed Sec.
26.187 [Substance abuse professional], the SAE would be required to
monitor the substance abuse treatment of individuals who require it and
so would have the qualifications and information necessary to assess
the quality of the treatment services an individual receives. The SAE
would have the authority to seek other services on behalf of the FFD
program if he or she identifies weaknesses in a treatment program.
Therefore, this change would be made to meet Goal 5 of this
[[Page 50500]]
rulemaking, which is to improve Part 26 by eliminating or modifying
unnecessary requirements.
Proposed Sec. 26.41(d) [Contracts] would incorporate and amend the
requirements of current Section 2.7(m) in Appendix A to Part 26 and
others, which address contractual relationships to permit licensees and
other entities access to the HHS-certified laboratories for the
purposes of conducting the audits and inspections required under the
rule. The portions of current Section 2.7(m) in Appendix A to Part 26
that relate to NRC inspections of HHS-certified laboratories would be
moved to Sec. 26.221 [Inspections] in Subpart K of the proposed rule,
consistent with Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule.
Proposed Sec. 26.41(d)(1) would amend the second sentence of
current Section 2.7(m) in Appendix A to Part 26, which requires
licensee contracts with HHS-certified laboratories for drug testing and
alcohol confirmatory testing, as well as contracts for collection site
services, to permit the licensee to conduct unannounced inspections.
The proposed rule would retain the current requirement with respect to
HHS-certified laboratories, and expand it to require that contracts
with any C/V (which would include collection services providers) must
permit the licensee or other entity to conduct audits at any time,
including unannounced times, and to review all information and
documentation that is reasonably relevant to the audits. The proposed
paragraph would extend the current requirement to any C/V with whom the
licensee or other entity contracts for FFD program services to enhance
the effectiveness of the licensees' and other entities' audits should
unannounced audits appear to be necessary. For example, a licensee or
other entity may receive allegations that an off-site C/V is falsifying
records or that a contract MRO or SAE is using drugs, and the licensee
or other entity may determine that an unannounced audit would provide
the most effective means to investigate such allegations. The proposed
paragraph would ensure that the licensee's or other entity's contract
with the C/V would permit the unannounced audit as well as access to
any information necessary to conduct the audit. Therefore, this
proposed change would be made to meet Goal 3 of this rulemaking, which
is to improve the effectiveness and efficiency of FFD programs.
Proposed Sec. 26.41(d)(2) would be added to ensure that licensees'
and other entities' contracts with C/Vs and HHS-certified laboratories
permit the licensee or other entity to obtain copies of and take away
any documents that auditors may need to assure that the C/V, its
subcontractors, or the HHS-certified laboratory are performing their
functions properly and that staff and procedures meet applicable
requirements. This proposed provision would respond to several
incidents in which parties under contract to licensees did not permit
Part 26 auditors to remove documents from a C/V's premises that were
necessary to document audit findings, develop corrective actions, and
ensure that the corrective actions were effective. Therefore, the
proposed requirement would meet Goal 3 of this rulemaking, which is to
improve the effectiveness and efficiency of FFD programs.
The proposed paragraph would permit HHS-certified laboratories to
reasonably limit the use and dissemination of the documentation that
auditors copy and take away from the laboratories, in order to protect
proprietary information and donors' confidentiality. This proposed
permission would be added in response to stakeholder requests at the
public meetings discussed in Section V. Because the current and
proposed rules permit sharing of audit reports among licensees and C/Vs
who rely on a laboratory, and it may be otherwise difficult to maintain
appropriate control of proprietary information or donors' personal
information, the NRC concurred with the stakeholders' request. This
proposed change would meet Goal 7 of this rulemaking, as it relates to
the privacy of individuals who are subject to Part 26, and would
protect the trade secrets of HHS-certified laboratories who would
continue to be subject to auditing under the proposed rule.
Proposed Sec. 26.41(d)(3) would amend the third sentence of
current Section 2.7(m) in Appendix A to Part 26, which requires
licensees and other entities to carry out inspections and evaluation of
the procedural aspects of an HHS-certified laboratory's drug testing
operations before awarding a contract to the laboratory, by adding a
cross-reference to proposed Sec. 26.41(g). Proposed Sec. 26.41(g)
would permit licensees and other entities to forgo the otherwise
required pre-award evaluation under certain specific circumstances, as
discussed with respect to that paragraph.
Proposed Sec. 26.41(e) [Conduct of audits] would retain the
requirements in current Sec. 26.80(b).
Proposed Sec. 26.41(f) [Audit results] would retain the portion of
current Sec. 26.80(c) that requires licensees and other entities to
document audit findings and recommendations, report them to senior
management, and document corrective actions taken in response to any
identified adverse conditions. The proposed paragraph would also add
two requirements. The second sentence of proposed Sec. 26.41(f) would
specify the required content of audit reports to include identification
of any conditions that are adverse to the proper performance of the FFD
program, the cause of the condition(s), and, when appropriate,
recommended corrective actions. The third sentence of the proposed
paragraph would require licensees and other entities to review the
audit findings and take corrective actions, including re-auditing of
the deficient areas where indicated, to preclude, within reason,
repetition of the condition. The proposed rule would add these two
sentences for consistency with Criterion XVI in Appendix B to 10 CFR
Part 50 to indicate that FFD audit reports are to be included in
licensees' and other entities' corrective action programs. Some
licensees have handled FFD audit reports outside of their normal
corrective action programs, which address other conditions adverse to
quality. As a result, some corrective actions for FFD program
weaknesses have not been timely or effective. Therefore, the proposed
rule would add these requirements to meet Goal 3 of this rulemaking,
which is to improve the effectiveness and efficiency of FFD programs.
The last sentence of current Sec. 26.80(c), which refers to the
requirements for auditing HHS-certified laboratories in Appendix A to
Part 26, would be deleted as redundant with proposed Sec. 26.41(c).
This proposed change would be made to meet Goal 6 of this rulemaking,
which is to improve clarity in the organization of the rule.
Proposed Sec. 26.41(g) [Sharing of audits] would respond to
licensees' implementation questions related to the third and fourth
sentences in current Sec. 26.80(a), which permit licensees and other
entities to accept audits of C/Vs that are conducted by other FFD
programs. The proposed paragraph would clarify the current permission
to accept and rely on others' audits in response to implementation
questions that the NRC has received from licensees with respect to the
sharing of audits, as documented in Section 17 of NUREG-1354, and items
11.4 and 11.5 of NUREG-1385.
Proposed Sec. 26.41(g) would amend the current provision to
incorporate specific permission for licensees and other entities to
jointly conduct audits as well
[[Page 50501]]
as rely on one another's audits. Reference to HHS-certified
laboratories would also be added to indicate the applicability of these
permissions to licensees' and other entities' audits of HHS-certified
laboratories. These proposed changes would be consistent with the
guidance issued by the NRC in the documents referenced above and
current licensee practices. Therefore, the proposed changes would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the organization and language of the rule.
Proposed Sec. 26.41(g)(1) and (g)(2) would be added to require
licensees and other entities to identify any areas that were not
covered by a shared or accepted audit and ensure that any unique
services used by the licensee or other entity that were not covered by
the shared audit are audited. For example, an FFD program may use lower
cutoff levels for drug testing than the FFD program(s) that conducted a
shared audit with the result that the shared audit did not address the
HHS-certified laboratories' procedures for testing at the first FFD
program's lower cutoff levels. In this case, the first FFD program
would not be permitted to rely on the shared audit with respect to the
lower cutoff levels and would be required to ensure that the HHS-
certified laboratories' procedures for testing at the lower cutoff
levels are audited separately (or in conjunction with other FFD
programs who use the same cutoff levels). These proposed provisions
would be consistent with the guidance issued by the NRC in the
documents referenced above and current licensee practices. Therefore,
the proposed changes would be made to meet Goal 6 of this rulemaking,
which is to improve clarity in the organization and language of the
rule.
Proposed Sec. 26.41(g)(3) would retain the portion of the third
sentence of current Sec. 26.80(a) that states that licensees and other
entities need not re-audit the same C/V for the same period of time,
and extend this permission to audits of HHS-certified laboratories.
Extending the current provision to cover audits of HHS-certified
laboratories would be consistent with the guidance issued by the NRC in
the documents referenced above and current licensee practices.
Therefore, this proposed change would be made to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.41(g)(4) would retain the fourth sentence of
current Sec. 26.80(a), which requires licensees and other entities to
retain copies of the shared audit reports.
Proposed Sec. 26.41(g)(5) would be added to permit licensees and
other entities to immediately obtain drug testing services from another
HHS-certified laboratory, subject to certain conditions, in the event
that the laboratory used by the licensee or other entity should lose
its certification. Within 3 months of obtaining services from the
replacement laboratory, the proposed paragraph would require the
licensee or other entity to ensure that an audit is conducted of any
aspects of the laboratory's services that are used by the licensee or
other entity that have not been audited within the past 12 months by
another licensee or entity who is subject to this part. This proposed
provision would enhance the effectiveness of FFD programs by ensuring
that drug testing would not be interrupted or delayed if an HHS-
certified laboratory loses its certification, as some licensees have
experienced. The reliability of drug testing services provided by the
replacement laboratory would be assured by the auditing and inspection
activities of other licensees and entities who have been using the
services of the replacement laboratory, as well as the audit conducted
by the licensee or other entity of any services that have not been
audited by other licensees or entities who are subject to this part.
The proposed change would be made to meet Goal 3 of this rulemaking,
which is to improve the effectiveness and efficiency of FFD programs.
Subpart C--Granting and Maintaining Authorization
Section 26.51 Purpose
A new Sec. 26.51 [Purpose] would be added to describe the purpose
of the proposed subpart. Proposed Sec. 26.51 would emphasize that
Subpart C contains ``FFD requirements'' for granting and maintaining
authorization because the NRC has also published other requirements
that establish additional steps that licensees and other entities must
take as part of the process of determining whether to grant
authorization to an individual. These additional requirements, found in
particular in 10 CFR 73.56 and access authorization orders issued by
the NRC to nuclear power plant licensees, require the licensee or other
entity to conduct a psychological assessment and a credit and criminal
history check of the individual, and to interview persons who have
knowledge of the applicant for authorization. A central goal of adding
Subpart C to the proposed rule is to eliminate redundancies and ensure
consistency between the FFD requirements and these other requirements.
Section 26.53 General Provisions
A new Sec. 26.53 [General provisions] would provide a generic
summary of the requirements and process for determining whether
individuals may be granted and maintain authorization.
Proposed Sec. 26.53(a) would introduce four new terms to Part 26:
(1) ``initial authorization,'' (2) ``authorization update,'' (3)
``authorization reinstatement,'' and (4) ``authorization with
potentially disqualifying FFD information.'' These terms would be used
to describe categories of proposed requirements for granting
authorization. The proposed categories, which are based upon whether an
individual who has applied for authorization has previously held
authorization under Part 26 and the length of time that has elapsed
since the individual's last period of authorization ended, are defined
in proposed Sec. 26.55 [Initial authorization], proposed Sec. 26.57
[Authorization update], proposed Sec. 26.59 [Authorization
reinstatement], and proposed Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information]. Proposed Sec.
26.53(a) would direct licensees or other entities to use the criteria
for granting authorization to individuals found in proposed Sec. Sec.
26.55, 26.57, 26.59, or 26.69, depending on which of the proposed
sections would apply to the individual seeking authorization. The
current rule in Sec. 26.27 discusses actions that the licensee must
take before the initial granting of access or assignment of specified
duties to an individual, but does not use the concepts of ``initial
authorization,'' ``authorization update,'' ``authorization
reinstatement,'' or ``authorization with potentially disqualifying FFD
information.'' These concepts would be used in the proposed rule to
focus the requirements for authorization more precisely on whether the
individual has established a ``track record'' in the industry, and to
specify the amount of original information gathering that licensees or
other entities would be required to perform according to whether
previous FFD programs have collected information about the individual.
In addition, the same concepts are used in access authorization
requirements, so incorporating them into Part 26 would increase the
consistency between the related regulations.
Proposed Sec. 26.53(b) would define the meaning of the term,
``interruption,'' which would be used in proposed Sec. 26.57
[Authorization update] and
[[Page 50502]]
proposed Sec. 26.59 [Authorization reinstatement] to refer to the
interval of time between periods during which an individual holds
authorization under Part 26. Licensees and other entities would
calculate an interruption in authorization as the total number of days
falling between the day upon which the individual's last period of
authorization ended and the day upon which the licensee or other entity
grants authorization to the individual. Proposed Sec. 26.53(b) would
also specify that if potentially disqualifying FFD information is
disclosed or discovered about an individual, licensees and other
entities must implement the applicable requirements in proposed Sec.
26.69 [Authorization with potentially disqualifying fitness-for-duty
information] in order to grant or maintain an individual's
authorization, rather than relying on the requirements in proposed
Sec. Sec. 26.55, 26.57, or 26.59, as discussed further with respect to
proposed Sec. 26.69.
Proposed Sec. 26.53(c) would reiterate the FFD training
requirements in proposed Sec. 26.29 [Training] and the fatigue
training requirements in proposed Sec. 26.197(c) [Training and
examinations] to clarify that all individuals must meet the applicable
requirements for initial or refresher FFD training, as appropriate,
before the licensee or other entity may grant authorization to the
individuals. The proposed paragraph would repeat the training
requirements for organizational clarity, because they apply to the
authorization process. As discussed in Section V, stakeholders
requested that the proposed rule present requirements in the order in
which they would apply to licensees' and other entities' FFD processes.
Therefore, the proposed paragraph would be added to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.53(d) would permit licensees and other entities
to rely upon other licensees' or entities' Part 26 programs and program
elements, as well as licensee-approved Part 26 programs and program
elements of C/Vs, to meet the requirements of this subpart for granting
and maintaining authorization. Proposed Sec. 26.53(d) would expand
upon two sections of the current rule that similarly permit licensees
and other entities to accept and rely upon other Part 26 programs and
program elements. Specifically, current Sec. 26.24(a)(1) permits
licensees to accept results from drug and alcohol tests that were
administered under another Part 26 program within the past 60 days, and
current Sec. 26.23 [Contractors and vendors] permits licensees to rely
upon C/Vs' Part 26 programs that have been formally reviewed and
approved by the licensee. Consistent with the principle of permitting
licensees to accept and rely upon other Part 26 programs in their
authorization decisions, guidance contained in NUREG-1385 also
indicates that licensees may ``accept'' an authorization granted by a
previous licensee for individuals who transfer between licensees with
only a ``short break'' in authorization. The proposed rule would
substantially increase the specificity of the requirements that must be
met by licensees or other entities for granting authorization and
establish detailed minimum standards that all programs must meet. These
proposed detailed minimum standards are designed to address recent
changes in industry practices that have resulted in a more transient
workforce, as noted in the discussion of Subpart C in Section IV. B.
Because the FFD programs of licensees and other entities would be
substantially more consistent than in the past under these proposed
detailed standards, permitting licensees and other entities to rely on
other Part 26 programs to meet the proposed rule's requirements is
reasonable and appropriate. In addition, the proposed provision would
eliminate unnecessary redundancies in the steps required to grant
authorization to an individual who is transferring from one Part 26
program to another.
Section 26.55 Initial Authorization
A new Sec. 26.55 [Initial authorization] would define the category
of ``initial authorization'' requirements to apply both to individuals
who have not previously held authorization under Part 26 and those
whose authorization has been interrupted for a period of 3 years or
more and whose last period of authorization ended favorably. Two
considerations support the proposed requirement for individuals whose
last period of authorization ended 3 or more years previously to
satisfy the same requirements as individuals who have never previously
held authorization. In general, the longer the period of time since the
individual's last period of authorization ended, the greater the
possibility that the individual has developed an active substance abuse
problem or undergone significant changes in lifestyle or character that
would diminish his or her trustworthiness, reliability, and ability to
perform work safely and competently. Therefore, it is reasonable to
require a full and extensive screening identical to that given an
individual who has not held authorization, and has not been subject to
drug and alcohol testing and behavioral observation, for 3 years or
more. For similar reasons, access authorization requirements also
require that individuals who have not held authorization for 3 years or
more must be subject to the same screening as individuals who have not
previously held authorization. Therefore, requiring individuals whose
last period of authorization ended 3 or more years previously to
satisfy the same requirements as individuals who have never held
authorization would increase the consistency of Part 26 with the
related access authorization requirements.
Proposed Sec. 26.55(a)(1) would require the licensee or other
entity, before granting initial authorization to an individual, to
obtain and review a self-disclosure in accordance with the applicable
requirements of proposed Sec. 26.61 [Self-disclosure and employment
history]. As discussed with respect to proposed Sec. 26.61, the self-
disclosure and employment history would require the individual to
report violations, if any, involving drugs or alcohol and the
individual's current and past employment history. The proposed
requirement is similar to the requirement in Sec. 26.27(a)(1) of the
current rule that a written statement must be obtained from the
individual addressing the topics that are specified in current Sec.
26.27(a)(1). The discussion of proposed Sec. 26.61 compares the topics
required to be addressed in the written statement under the current
rule with the topics that would be addressed in the self-disclosure
under the proposed rule. As discussed with respect to proposed Sec.
26.61(a)(3), the period of time to be addressed in the self-disclosure
by an applicant for initial authorization would be the shorter period
of either the past 5 years or the interval of time since the
individual's eighteenth birthday.
Proposed Sec. 26.55(a)(2) would require the licensee or other
entity, before granting initial authorization to an individual, to
complete a suitable inquiry in accordance with the applicable
requirements of proposed Sec. 26.63 [Suitable inquiry]. The proposed
requirement is similar to the requirement in Sec. 26.27(a)(2) of the
current rule that a suitable inquiry must be completed addressing the
topics that are specified in Sec. 26.27(a)(2). The discussion of
proposed Sec. 26.63 compares the topics that must be addressed in the
suitable inquiry under the current rule with the topics that would be
addressed in the suitable inquiry under the proposed rule. Proposed
Sec. 26.63(f)(1) specifies that the
[[Page 50503]]
period of time that the suitable inquiry would address for an initial
authorization must be the shorter period of either the past 3 years or
the interval of time since the individual's eighteenth birthday.
Proposed Sec. 26.55(a)(3) would require the licensee or other
entity, before granting initial authorization to an individual, to
ensure that the individual is subject to pre-access drug and alcohol
testing in accordance with the applicable requirements of proposed
Sec. 26.65 [Pre-access drug and alcohol testing]. Current Sec.
26.24(a)(1) requires testing within 60 days prior to the initial
granting of unescorted access to protected areas or assignment to
activities within the scope of Part 26. The discussion of proposed
Sec. 26.65 compares the proposed pre-access drug and alcohol testing
requirements for initial authorization to the requirements in the
current rule. Proposed Sec. 26.65 would require the licensee or other
entity to ensure that the individual had negative drug and alcohol test
results from testing that had been completed within the past 30 days
before granting authorization to the individual, for the reasons
discussed with respect to that section.
Proposed Sec. 26.55(a)(4) would require the licensee or other
entity also to ensure that the individual is subject to random drug and
alcohol testing in accordance with the applicable requirements of
proposed Sec. 26.67 [Random drug and alcohol testing of individuals
who have applied for authorization]. Current Sec. 26.64(a)(2) requires
unannounced drug and alcohol tests imposed in a statistically random
and unpredictable manner. The discussion of proposed Sec. 26.67
compares the proposed random drug and alcohol testing requirements for
initial authorization to the requirements in the current rule.
Proposed Sec. 26.55(b) would be added to require that the licensee
or other entity must meet the requirements in proposed Sec. 26.69
[Authorization with potentially disqualifying fitness-for-duty
information] to grant authorization to the individual, if potentially
disqualifying FFD information is disclosed or discovered about the
individual who is applying for authorization that has not previously
been evaluated by another licensee or other entity.
Section 26.57 Authorization Update
Proposed new Sec. 26.57 [Authorization update] would define the
category of ``authorization update'' requirements for granting
authorization to individuals whose authorization has been interrupted
for more than 365 days but less than 3 years and whose last period of
authorization was terminated favorably. As noted in the discussion of
Subpart C in Section IV. C, the proposed requirements for granting an
authorization update would be less stringent than the proposed
requirements for granting initial authorization. The proposed
requirements would be less stringent for two reasons: (1) The
individual who is applying for an authorization update would have a
more recent ``track record'' of successful performance within the
industry, and (2) the licensee or other entity would have access to
information about the individual from the licensee or other entity who
last granted authorization to him or her because of the increased
information-sharing requirements of the proposed rule. However, the
licensee or other entity would not have information about the
individual's activities during the period of the interruption, so the
proposed rule's requirements for an authorization update would focus on
gathering and evaluating information from the interruption period. For
example, in the case of an individual whose last period of
authorization ended 2 years ago, the licensee or other entity would
focus on gathering information about the individual's activities within
the 2-year interruption period. If an individual's last period of
authorization ended 13 months ago, the licensee or other entity would
focus on gathering information about the individual's activities within
those 13 months.
Proposed Sec. 26.57(a), like proposed Sec. 26.55(a), would
require the licensee or other entity, before granting authorization,
to: (1) Obtain and review a self-disclosure in accordance with the
applicable requirements of proposed Sec. 26.61; (2) complete a
suitable inquiry in accordance with the applicable requirements of
proposed Sec. 26.63; (3) ensure that the individual is subject to pre-
access drug and alcohol testing in accordance with the applicable
requirements of proposed Sec. 26.65; and (4) ensure that the
individual is subject to random drug and alcohol testing in accordance
with the applicable requirements of proposed Sec. 26.67. However,
proposed Sec. 26.61(c)(3)(iii) would limit the period of time to be
addressed in the self-disclosure and employment history to the
interruption period. That is, if an individual's last period of
authorization ended 2 years ago, the self-disclosure and employment
history would cover only the past 2 years. Similarly, proposed Sec.
26.63(f)(2) would provide that the suitable inquiry for an
authorization update must cover the interruption period. The proposed
rule would require only that the interruption period must be addressed
in the self-disclosure, employment history, and suitable inquiry
because the licensee or other entity would obtain information from
earlier periods in the individual's history from the licensee or other
entity who had last granted authorization to the individual.
Proposed Sec. 26.57(b) would be added to specify that if
potentially disqualifying FFD information is disclosed or discovered
about the individual who is applying for authorization, the licensee or
other entity may not grant authorization to the individual, except in
accordance with proposed Sec. 26.69.
Section 26.59 Authorization reinstatement
A new Sec. 26.59 [Authorization reinstatement] would establish two
categories of authorization reinstatement requirements for individuals
whose authorization has been interrupted for a short period and whose
last period of authorization was terminated favorably, for the reasons
discussed in Section IV. C. One category of authorization reinstatement
requirements would apply to individuals whose authorization has been
interrupted for more than 30 days but no more than 365 days in proposed
Sec. 26.59(a), and the other to individuals whose authorization has
been interrupted for 30 or fewer days in proposed Sec. 26.59(c). The
proposed steps for reinstating an individual's authorization after an
interruption of 365 or fewer days would be less stringent than those
required for initial authorization or an authorization update because
these individuals have a recent, positive track record within the
industry and so would pose little risk to public health and safety or
the common defense and security.
The proposed requirements that are related to an individual whose
authorization has been interrupted for more than 30 days but no more
than 365 days would be more extensive than the requirements for
granting authorization to an individual whose authorization has been
interrupted for 30 or fewer days. The proposed requirements for the 31-
365 day category would be consistent with those contained in the access
authorization orders issued by the NRC to nuclear power plant licensees
dated January 7, 2003. However, the proposed requirements for
individuals whose authorization has been interrupted for 30 or fewer
days
[[Page 50504]]
would be more stringent than those contained in the access
authorization orders issued by the NRC to nuclear power plant licensees
dated January 7, 2003. Under the access authorization orders, licensees
are required to obtain and review a self-disclosure and employment
history from the applicant before reinstating the individual's
authorization. Under the proposed rule, licensees and other entities
would also be required to subject the individual to the possibility of
being selected for pre-access testing in accordance with proposed Sec.
26.65(e) [Authorization reinstatement after an interruption of 30 days
or less]. The NRC has determined that this additional proposed
requirement is necessary to meet the proposed rule's performance
objective of providing reasonable assurance that individuals are
trustworthy and reliable, as discussed with respect to proposed Sec.
26.23(a), by extending the deterrent effect of pre-access testing to
individuals who have had an interruption in authorization of 30 or
fewer days in length.
For individuals whose authorization has been interrupted for 31-365
days, proposed Sec. 26.59(a)(1) would require the licensee or other
entity to obtain and review a self-disclosure and employment history in
order to reinstate authorization. Consistent with the requirements for
authorization updates in proposed Sec. 26.57, the proposed rule in
Sec. 26.61(c)(3)(iii) would limit the period of time to be addressed
in the self-disclosure and employment history to the period of the
interruption in authorization. A self-disclosure and employment history
for earlier periods of time would be unnecessary because the granting
licensee or other entity would have access to information about the
individual from the licensee or other entity who had recently
terminated the individual's authorization.
By contrast to the proposed requirements for an initial
authorization and an authorization update, proposed Sec. 26.59(a)(2)
would permit the licensee or other entity to reinstate an individual's
authorization without first completing the suitable inquiry. The
proposed rule would permit the licensee or other entity to reinstate
the individual's authorization before completing the suitable inquiry
because these individuals have a recent, positive track record within
the industry and would pose little risk to public health and safety or
the common defense and security. As would be required for an
authorization update, the proposed rule would limit the period of time
to be addressed by the suitable inquiry to the interruption period in
proposed Sec. 26.63(f)(3). However, the proposed paragraph would
require licensees and other entities to ensure that the suitable
inquiry is completed within 5 days after reinstating the individual's
authorization. If the suitable inquiry is not completed within the 5-
day period permitted, the proposed rule would permit the licensee or
other entity to maintain the individual's authorization for up to 10
days following the day upon which authorization was reinstated, but
only if the licensee or other entity is unaware of any potentially
disqualifying information about the individual. If the suitable inquiry
is not completed within the 10 days permitted, the proposed rule would
require the licensee or other entity to administratively withdraw the
individual's authorization until the suitable inquiry is completed.
Proposed Sec. 26.59(a)(3) and (a)(4) would require the licensee or
other entity to ensure that the individual whose authorization has been
interrupted for 31-365 days is subject to pre-access drug and alcohol
testing and random testing, respectively. Proposed Sec. 26.65(d)
[Authorization reinstatement after an interruption of more than 30
days] would establish pre-access drug and alcohol testing requirements
for authorization reinstatements. Proposed Sec. 26.67 [Random drug and
alcohol testing of individuals who have applied for authorization]
would specify the requirements for random testing of individuals who
are applying for an authorization reinstatement.
Proposed Sec. 26.59(b) would be added to ensure that any
administrative withdrawal of authorization that would be required under
proposed Sec. 26.59(a)(2) would not be reported or recorded as an
unfavorable termination of authorization, unless and until the suitable
inquiry is completed and it indicates that authorization should not be
granted. This proposed provision would ensure that an individual's
temporary administrative withdrawal of authorization, caused by a delay
in completing the suitable inquiry, would not be treated as an
unfavorable termination caused by an FFD violation. This proposed
provision would be necessary to meet Goal 7 of this rulemaking, which
is to protect the due process rights of individuals who are subject to
Part 26, by ensuring that they are not subject to any adverse
consequences for the licensee's or other entity's delay in completing
the suitable inquiry.
Proposed Sec. 26.59(c) would establish authorization requirements
for individuals whose authorization has been interrupted for 30 or
fewer days. Proposed Sec. 26.59(c)(1) would require the licensee or
other entity to obtain and review a self-disclosure from the applicant
for authorization with certain exceptions that would be specified in
proposed Sec. 26.61 [Self-disclosure and employment history]. The
licensee or other entity would be permitted to forego conducting a
suitable inquiry for individuals whose authorization has been
interrupted for such a short period. Proposed Sec. 26.59(c)(2) would
permit licensees and other entities also to forego pre-access drug and
alcohol testing of individuals whose authorization has been interrupted
for 5 or fewer days, but pre-access testing may be required under
proposed Sec. 26.65(e) for individuals whose authorization has been
interrupted for 6-30 days. Exceptions to the self-disclosure and pre-
access testing requirements in this proposed paragraph would be
specified in proposed Sec. Sec. 26.61 and 26.65, respectively.
Section 26.61 Self-Disclosure and Employment History
A new Sec. 26.61 [Self-disclosure and employment history] would
replace current Sec. 26.27(a)(1) for the reasons discussed in Section
IV.C. The proposed rule would replace the term, ``written statement,''
in the current rule with the phrase,'' self-disclosure and employment
history,'' to more accurately characterize the requirement. This
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the language of the rule.
Proposed Sec. 26.61(a) would be added to require licensees and
other entities to obtain a written self-disclosure and employment
history from every applicant before granting authorization to the
individual, except in two circumstances, as follows:
Proposed Sec. 26.61(a)(1) would permit the licensee or other
entity to forego obtaining a self-disclosure and employment history, if
all three of the following conditions are met: (1) The individual
previously held authorization under Part 26; (2) the individual's last
period of authorization was terminated favorably; and (3) the
individual was subject to a behavioral observation and arrest-reporting
program that meets the requirements of this part throughout the time
interval during which the individual's authorization was interrupted.
The information to be obtained from the self-disclosure and employment
history would be unnecessary in these circumstances, because it would
already be available to the granting licensee or
[[Page 50505]]
other entity from the Part 26 program that had been implementing the
behavioral observation and arrest-reporting program during the
interruption in the individual's authorization. A requirement for
licensees and other entities to conduct another suitable inquiry would
be redundant and impose an unnecessary burden.
Proposed Sec. 26.61(a)(2) would permit licensees and other
entities to forego obtaining an employment history from applicants for
an authorization reinstatement whose authorization has been interrupted
for 30 or fewer days. The employment history information would be
unnecessary in this case, because the proposed rule would not require
licensees or other entities to conduct a suitable inquiry for
individuals who have had such a short break in authorization.
Proposed Sec. 26.61(b) would be added to specify the required
content of the self-disclosure. Affirmative responses to any of the
questions in proposed Sec. 26.61(b)(1) would be considered potentially
disqualifying FFD information, as defined in proposed Sec. 26.5
[Definitions]. The proposed rule would expand the scope of the
questions to be asked from those required in current Sec. 26.27(a)(1)
in order to provide greater assurance that individuals would disclose
information with regard to indicators of an active substance abuse
problem or an increased risk of recidivism into an active substance
abuse problem after treatment. Current Sec. 26.27(a)(2) requires
information about whether the applicant ``tested positive for drugs or
use of alcohol that resulted in on-duty impairment.'' Proposed Sec.
26.61(b)(1) would require information about whether the applicant used,
sold, or possessed illegal drugs, subverted or attempted to subvert a
drug or alcohol testing program, or refused to take a drug or alcohol
test. Both current Sec. 26.27(a)(2) and proposed Sec. 26.61(b)(1)
require information on whether the applicant has been subject to a plan
for substance abuse treatment (except for a self-referral). Both
require information about previous denials or terminations of
authorization.
Proposed Sec. 26.61(b)(2) would be added to require the applicant
to disclose the circumstances surrounding any potentially disqualifying
FFD information and the resolution of the matter. For example, proposed
Sec. 26.61(b)(1) would require an applicant to report an arrest on
drug-related charges, while proposed Sec. 26.61(b)(2) would require
the applicant to report the outcome of the arrest (e.g., charges, a
conviction, a finding of not guilty, the dropping of the charges).
Proposed Sec. 26.61(b)(3) would define the time period to be
addressed in the self-disclosure. The proposed rule would establish a
time limit on the number of years in the past that an individual would
be required to report and account for potentially disqualifying FFD
information. One purpose of the self-disclosure is to identify
indicators of an active substance abuse problem or an increased risk of
recidivism into an active substance abuse problem after treatment. The
relevant research literature indicates that there is a decrease in
post-treatment recidivism (i.e., relapse) rates after 3 years of no
further substance abuse, and a larger decrease in the recidivism rate
after 5 years. If no indicators of a substance abuse problem within the
past 5 years are disclosed (or since the applicant's eighteenth
birthday in the case of an applicant who is less than 23 years of age),
an applicant for initial authorization (see proposed Sec. 26.55) would
not be required to disclose earlier substance-abuse-related events. For
applicants who held authorization within the past 3 years, the self-
disclosure would address only the time interval since the individual's
last period of authorization ended. However, the licensee or other
entity would obtain further information about the applicant over the
past 5 years from reviewing the information made available by licensees
or other entities who had granted authorization to the applicant in the
past. This information would include information developed as part of
previous suitable inquiries (see proposed Sec. 26.63) as well as
information from the period(s) during which the individual was subject
to other Part 26 programs.
Proposed Sec. 26.61(c) would be added to require applicants to
provide information about current and past employers, which the
licensee or other entity would then use for the suitable inquiry, if a
suitable inquiry is required under proposed Sec. 26.63 [Suitable
inquiry].
Proposed Sec. 26.61(d) would replace and expand upon current Sec.
26.27(a)(4). The proposed rule would add falsification of the self-
disclosure or employment history as sufficient reasons to deny
authorization to an individual in order to deter falsification
attempts. Reference to temporary access authorization would be deleted
from the proposed paragraph because temporary access authorization
would no longer be permitted under Part 26, for the reasons discussed
in Section IV.C.
Section 26.63 Suitable Inquiry
A new Sec. 26.63 [Suitable inquiry] would amend current Sec.
26.27(a)(2) and the requirements related to conducting a suitable
inquiry that are contained within the definition of the term,
``suitable inquiry,'' in current Sec. 26.3 [Definitions]. The current
rule defines a suitable inquiry as a ``best-effort verification of
employment history for the past 5 years, but in no case less than 3
years, obtained through contacts with previous employers to determine
if a person was, in the past, tested positive for illegal drugs,
subject to a plan for treating substance abuse, removed from, or made
ineligible for activities within the scope of 10 CFR Part 26, or denied
unescorted access at any other nuclear power plant or other employment
in accordance with a fitness-for-duty policy.'' In general, the
proposed changes to the current requirements are intended to: (1)
Better focus the suitable inquiry on indicators of an active substance
problem and/or an increased risk of recidivism into an active substance
abuse problem following treatment, as discussed in Section IV.C; (2)
increase the consistency in implementing suitable inquiries among FFD
programs by providing more detailed requirements, also as discussed in
Section IV.C; and (3) improve Part 26 by eliminating or modifying
unnecessary requirements, which is Goal 5 of this rulemaking, as
discussed in Section IV.B.
For all authorization categories, the suitable inquiry would be
more thorough than previous industry practices, in order to increase
the likelihood that potentially disqualifying FFD information would be
identified, if it existed, and to provide reasonable assurance that
individuals are trustworthy and reliable, as demonstrated by avoiding
substance abuse. For individuals who have established a recent,
favorable work history under Part 26, as demonstrated by having held
authorization that was terminated favorably within the past 3 years,
the period of time addressed in the suitable inquiry would be reduced
from the past 5 years in every case, to the past 3 years or less,
depending upon how recently the applicant held authorization. If
potentially disqualifying FFD information within the past 5 years is
identified regarding an applicant and the information has not been
addressed and favorably resolved by a previous licensee or other
entity, the suitable inquiry requirements would be more extensive, as
described in proposed Sec. 26.69 [Authorization with
[[Page 50506]]
potentially disqualifying fitness-for-duty information].
Proposed Sec. 26.63(a) would be added to require licensees and
other entities to conduct a suitable inquiry for two purposes. One
purpose would be to verify the information provided by the applicant in
the self-disclosure and employment history obtained under proposed
Sec. 26.61. The second purpose would be to determine whether
additional potentially disqualifying FFD information is available
regarding the applicant. The proposed paragraph would also establish
the circumstances in which a licensee or other entity would be
permitted to forego the suitable inquiry in order to grant
authorization to individuals. A licensee or other entity would be
permitted to forego the suitable inquiry if all three of the following
conditions are met: (1) The individual previously held authorization
under Part 26; (2) the individual's last period of authorization was
terminated favorably; and (3) the individual was subject to a
behavioral observation and arrest-reporting program that meets the
requirements of this part throughout the period during which the
individual's authorization was interrupted. The information to be
obtained from a suitable inquiry would be unnecessary in these
circumstances, because it would already be available to the granting
licensee or other entity from the Part 26 program that implemented the
behavioral observation and arrest-reporting program during the
interruption in authorization.
Proposed Sec. 26.63(b) would be added to permit licensees and
other entities to rely upon suitable inquiry information that was
gathered by previous licensees and other entities who are subject to
this part. This proposed provision would reduce the number of redundant
suitable inquiries that licensees and other entities must conduct, when
the suitable inquiries would address the same employers and same time
periods. The proposed paragraph would also permit licensees and other
entities to accept the results of any determinations of fitness that
were performed under a previous Part 26 program, rather than requiring
each new licensee and other entity to reevaluate the same information
that was reviewed and resolved in accordance with the same requirements
under another Part 26 program. This proposed change would be made to
meet Goal 5 of this rulemaking, which is to improve Part 26 by
eliminating or modifying unnecessary requirements.
Proposed Sec. 26.63(c) would be added to specify requirements for
the manner in which licensees and other entities must conduct the
suitable inquiry. Licensees and other entities would be required to
demonstrate a ``best effort'' to complete the suitable inquiry. The
``best effort'' criterion recognizes licensees' and other entities'
status as commercial entities with no legal authority to require the
release of the information from other private employers and educational
institutions. Because of privacy and potential litigation concerns,
some private employers and educational institutions may be unable or
unwilling to release qualitative information about a former employee or
student. For example, a former employer may verify the dates that an
individual was employed by the company, but may be unwilling to reveal
that the individual had been in treatment for drug or alcohol abuse
while employed with the company. Therefore, the ``best effort''
criterion would require licensees and other entities to seek suitable
inquiry information from the primary source (e.g., a company, private
employer, or educational institution that the applicant has listed on
his or her employment history), but recognizes that it may not be
forthcoming. The ``best effort'' criterion in the proposed paragraph
would be consistent with the ``best-efforts basis'' in current Sec.
26.27(a)(2), but the proposed rule would provide more detailed
requirements in response to questions that the NRC has received from
licensees about implementing a suitable inquiry on a ``best effort''
basis since Part 26 was first promulgated.
Proposed Sec. 26.63(c)(1) would be added to specify the type of
information that the licensee or other entity must seek from employers
regarding the applicant for authorization. The proposed paragraph would
require the licensee or other entity to ascertain the reason that the
individual's employment was terminated, his or her eligibility for
rehire, and other information that could reflect on the individual's
fitness to be granted authorization. The proposed requirement to obtain
this information would be consistent with long-standing industry
practices related to granting access authorization and related
requirements in the access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
Proposed Sec. 26.63(c)(2) would specify the type of information
that licensees and other entities must seek when an applicant's claimed
periods of employment include military service. The proposed
requirement would be added for consistency with related requirements in
the access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003.
Proposed Sec. 26.63(c)(3) also would be added to provide
consistency with related requirements in the access authorization
requirements established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003. The proposed
paragraph would address circumstances in which a primary source of
information refuses to provide the necessary suitable inquiry
information or indicates an inability or unwillingness to provide it
within 3 days of the request. Licensees and other entities would be
required to document that the request for information was directed to
the primary source and the nature of the response (i.e., a refusal,
inability, or unwillingness). If a licensee or other entity encounters
the circumstances addressed in proposed Sec. 26.63(c)(3), the proposed
paragraph would require the licensee or other entity to seek suitable
inquiry information from an alternate source, to the extent of the
alternate source's ability to provide the information. An alternate
source may include, but would not be limited to, a co-worker or
supervisor at the same company who had personal knowledge of the
applicant, if such an individual could be located. However, the
proposed rule would prohibit the licensee or other entity from using
the alternate source of suitable inquiry information to meet any other
access authorization requirements for a character reference. The
proposed rule would permit licensees and other entities to grant
authorization, if warranted, when a response has been obtained from an
alternate source, without waiting more than 3 days after the request
for information was directed to a primary source. These proposed
alternative methods of meeting the suitable inquiry requirement are
necessary because, as discussed with respect to proposed Sec.
26.63(c), some employers are unwilling or unable to provide suitable
inquiry information.
Proposed Sec. 26.63(d) would be added to require licensees and
other entities who are subject to this part to share suitable inquiry
information that they have collected when contacted by another licensee
or entity who has a release that would permit the sharing of that
information signed by the applicant for authorization. This proposed
provision would restate the permission to release suitable inquiry
information in current Sec. 26.29(b) as a requirement that licensees
and other entities must
[[Page 50507]]
share the information necessary to conduct the suitable inquiry. The
proposed provision would also clarify that the information must also be
released to C/Vs who have licensee-approved FFD programs when the C/V
presents the required signed release from the applicant. This proposed
clarification is necessary because some licensees have misinterpreted
current Sec. 26.29(b) as prohibiting the release of suitable inquiry
information to C/Vs who have licensee-approved FFD programs. The
proposed paragraph would also permit a licensee or other entity to deny
authorization to an individual if the individual will not sign the
release necessary to permit the licensee or other entity to conduct the
suitable inquiry. The proposed provisions would be consistent with
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003.
Proposed Sec. 26.63(e) would be added to permit licensees and
other entities to use electronic means of obtaining the suitable
inquiry information. This proposed permission would be consistent with
access authorization requirements established in 10 CFR 73.56, as
supplemented by orders to nuclear power plant licensees dated January
7, 2003. The proposed paragraph would also add cross-references to the
applicable records retention requirements in proposed Sec. 26.211
[General provisions] and proposed Sec. 26.213 [Recordkeeping
requirements for licensees and other entities] in proposed Subpart J
[Recordkeeping and Reporting Requirements] to ensure that licensees and
other entities are aware of the applicability of these requirements to
the suitable inquiry information obtained electronically. The proposed
change would be consistent with Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule.
Proposed Sec. 26.63(f) would be added specify the period(s) of
time that the suitable inquiry must address for applicants for initial
authorization, authorization update, and authorization reinstatement.
The proposed paragraph would also specify additional requirements for
conducting the suitable inquiry for these authorization categories, as
follows:
Proposed Sec. 26.63(f)(1) [Initial authorization] would require
licensees and other entities to conduct a suitable inquiry to address
the 3-year period preceding the date upon which the individual applies
for authorization. The period of time to be addressed in the suitable
inquiry for applicants for initial authorization who do not disclose
any potentially disqualifying FFD information would be reduced from 5
years in the current regulation to 3 years for two reasons: First, one
purpose of the suitable inquiry is to identify indicators of an active
substance abuse problem or an increased risk of recidivism following
treatment. Therefore, if no potentially disqualifying FFD information
is disclosed by an applicant for initial authorization from the past 5
years and none is identified through the suitable inquiry or other
means, it is unlikely that the applicant has an active substance abuse
problem. Therefore, seeking a full 5 years of information about the
individual would unlikely provide useful information and imposes an
unnecessary burden. Second, industry experience has shown that
employers are often reluctant to disclose adverse information to other
private employers about former employees, and that the longer it has
been since an individual was employed, the less likely it is that a
former employer will disclose useful information. Therefore, rather
than retaining the requirement for a 5-year suitable inquiry in all
cases, the proposed rule would increase the thoroughness of the
suitable inquiry into the past 3 years.
Proposed Sec. 26.63(f)(1) would be added to require the licensee
or other entity to conduct the suitable inquiry with every employer by
whom the applicant claims to have been employed within the past year.
This proposed requirement to conduct the suitable inquiry with every
claimed employer would be a more rigorous suitable inquiry than was
common industry practice prior to issuance of the January 7, 2003,
access authorization orders, which imposed additional compensatory
measures related to access authorization. The purpose of contacting
every employer would be to ensure that the licensee or other entity
sought information related to any active substance abuse problem. For
the earlier 2 years of the suitable inquiry period, the proposed
paragraph would require the licensee or other entity to conduct the
suitable inquiry with every employer by whom the applicant claims to
have been employed the longest within each calendar month. Contacting
these employers would increase the likelihood that the employers would
have knowledge of the applicant and so may provide more useful
information than contacting employers by whom the applicant was
employed only briefly.
Proposed Sec. 26.63(f)(2) [Authorization update] would be added to
specify the period of time that the suitable inquiry must address for
applicants for an authorization update (i.e., those who held
authorization within the past 3 years and whose last period of
authorization was terminated favorably, but who have not held
authorization within the past year). The proposed paragraph would
require the licensee or other entity to conduct the suitable inquiry in
the same manner as described in proposed Sec. 26.63(f)(1). However,
for an authorization update, the suitable inquiry would address only
the period that the individual's authorization was interrupted, rather
than the full 3 years that would be required for initial authorization.
A 3-year period for the suitable inquiry would be unnecessary for these
individuals, because the licensee or other entity would have access to
the information about the individual that was gathered by the licensee
or other entity under whose program the individual had been granted and
successfully maintained authorization within the past 3 years.
Proposed Sec. 26.63(f)(3) [Authorization reinstatement after an
interruption of more than 30 days] would specify the period of time
that the suitable inquiry must address for applicants who held
authorization within the past year and whose last period of
authorization was terminated favorably, but who have not held
authorization within the past 30 days. The proposed rule would require
licensees and other entities to contact employers by whom the applicant
claims to have been employed the longest in each calendar month of the
interruption. The proposed rule would not require licensees and other
entities to contact every employer by whom the individual claimed to
have been employed during the interruption for the reasons discussed
with respect to proposed Sec. 26.59(a)(2). Because these individuals
have had only a short break in authorization, a sampling of employers
from the interruption period would be sufficient to determine whether
any indications exist that the individual had developed a previously
undetected substance abuse or other problem that would adversely affect
his or her fitness to have authorization reinstated.
The time periods and approach to conducting the suitable inquiry
established in proposed Sec. 26.63(f)(1)-(f)(3) would be consistent
with those established in the access authorization orders issued to
nuclear power plant licensees dated January 7, 2003.
[[Page 50508]]
Section 26.65 Pre-Access Drug and Alcohol Testing
Proposed Sec. 26.65 [Pre-access drug and alcohol testing] would
amend current Sec. 26.24(a)(1), which requires drug and alcohol
``testing within 60 days prior to the initial granting of unescorted
access to protected areas or assignment to activities within the scope
of this part.'' The proposed section would amend the current pre-access
drug and alcohol testing requirement for individuals who are seeking
authorization under Part 26 to strengthen the effectiveness of FFD
programs, as discussed in Section IV. C.
Proposed Sec. 26.65(a) [Purpose] would be added to describe the
purpose of the section and identify the individuals to whom the
requirements in the proposed section would apply. The pre-access
testing requirements in this section would cover applicants for
authorization (1) who have never held authorization under Part 26 or
have held authorization under Part 26 and whose most recent period of
authorization was terminated favorably, and (2) about whom no
potentially disqualifying FFD information has been discovered or
disclosed that was not reviewed and favorably resolved by another
licensee or entity. Requirements for granting authorization to
individuals whose previous periods of authorization were terminated
unfavorably or denied, or about whom new potentially disqualifying FFD
information has been discovered or disclosed, would be contained in
proposed Sec. 26.69 [Authorization with potentially disqualifying
fitness-for-duty information].
Proposed Sec. 26.65(b) [Accepting tests conducted within the past
30 days] would be added to permit licensees and other entities to
forego pre-access testing of an individual who has negative test
results from drug and alcohol tests that were performed in accordance
with the requirements of Part 26 within the 30-day period before the
licensee or other entity grants authorization to the individual,
including tests that were conducted before the individual applied for
authorization from the licensee or other entity. For example, if an
individual was subject to random testing under another Part 26 program
and was selected for testing under the other program before applying
for authorization from the granting licensee or other entity: the
proposed rule would permit the granting licensee or other entity to
accept negative test results from the random test in lieu of performing
a pre-access test, if the random test was conducted within 30 days
before the day upon which authorization is granted to the individual. A
requirement for the licensee or other entity to conduct pre-access
testing in these circumstances would be redundant and unnecessary.
Proposed 26.65(c) [Initial authorization and authorization update]
would be added to establish pre-access testing requirements for
individuals who are applying for initial authorization and an
authorization update. The proposed rule would require negative results
from pre-access testing before the licensee or other entity could grant
authorization to the individual, except in the two circumstances
described in proposed Sec. 26.65(c)(1) and (c)(2). In proposed Sec.
26.65(c)(1), licensees and other entities would be permitted to forego
pre-access testing if the applicant had been subject to drug and
alcohol testing (including random testing), behavioral observation, and
arrest-reporting requirements under a Part 26 FFD program throughout
the period during which the individual's authorization was interrupted.
In proposed Sec. 26.65(c)(2), licensees and other entities would be
permitted to forego pre-access testing of an applicant who had negative
test results from Part 26 drug and alcohol tests that were performed
within the past 30 days and was subject to behavioral observation and
arrest-reporting requirements during the time interval between the day
upon which the specimens were collected and the day the licensee or
other entity grants authorization to the individual. Pre-access testing
in these two circumstances would be unnecessary because there would be
sufficient opportunity to detect substance abuse without it.
Proposed paragraphs Sec. 26.65(d) [Authorization reinstatement
after an interruption of more than 30 days] and (e) [Authorization
reinstatement after an interruption of 30 days or fewer] would be added
to establish requirements for pre-access testing of individuals who are
applying for an authorization reinstatement. The proposed requirements
for pre-access testing of these individuals would be less stringent
than the requirements for initial authorization and an authorization
update. The proposed provision would also relax the pre-access testing
requirements in current Sec. 26.24(a)(1), which require all applicants
for authorization to be subject to pre-access testing within 60 days
before granting authorization. Less stringent pre-access testing
requirements would be appropriate because these individuals have (1)
met the rigorous criteria for initial authorization; (2) established a
recent record of successfully maintaining authorization under Part 26;
and (3) had only a short break in authorization.
Proposed Sec. 26.65(d) would specify pre-access testing
requirements for individuals whose authorization has been interrupted
for more than 31 days but no more than one year. Proposed Sec.
26.65(d)(1)(i) would require the licensee or other entity to administer
an alcohol test and collect a urine specimen for drug testing. The
licensee or other entity would be permitted to reinstate the
individual's authorization if the alcohol test results are negative,
before the drug test results are available. Proposed Sec.
26.65(d)(1)(ii) would permit the licensee or other entity to maintain
the individual's authorization for 5 days after reinstatement without
receiving the drug test results. But, if the licensee or other entity
does not receive negative drug test results within 5 days of
reinstating the individual's authorization, the proposed rule would
require the licensee or other entity to administratively withdraw the
individual's authorization until negative drug test results are
received. These proposed requirements would ensure that individuals
whose authorization has been interrupted for more than 30 days are
subject to pre-access drug and alcohol testing to deter substance abuse
and to detect any current substance abuse problem. However, the
proposed provisions would not unduly delay authorization reinstatement,
given that these individuals' recent successful histories of
maintaining authorization under Part 26 indicates that they are at low
risk of engaging in substance abuse. Proposed Sec. 26.65(d)(2) would
permit licensees and other entities to forego pre-access testing of
these applicants for reinstatement in the circumstances discussed with
respect to proposed Sec. 26.65(c)(1) and (c)(2).
Proposed Sec. 26.65(e)(1) would be added to permit licensees and
other entities to forego pre-access testing of applicants whose
authorization has been interrupted for 5 or fewer days. This proposed
provision would be consistent with current licensee practices and
recommendations regarding ``short breaks'' in authorization in NUREG-
1385 and other access authorization requirements.
However, proposed Sec. 26.65(e)(2) would require licensees and
other entities to subject applicants whose authorization has been
interrupted for 6-30 days to the possibility of being selected for pre-
access testing in order to deter any potential for substance abuse.
Proposed Sec. 26.65(e)(2)(i) would require the licensee or other
entity to subject the applicant to a one-time
[[Page 50509]]
chance of being selected for testing at a probability of approximately
4 percent. This proposed probability approximates the likelihood that
individuals who are subject to random testing at the 50 percent annual
testing rate in proposed Sec. 26.31(d)(2)(vi) would be selected for
testing at some point within a 30-day period. Proposed Sec.
26.65(e)(2)(ii) would clarify that, if an applicant is not selected for
pre-access testing under the preceding paragraph, the licensee or other
entity would not be required to perform a pre-access test. Proposed
Sec. 26.65(e)(2)(iii)(A) and (B) would specify requirements for
conducting the pre-access testing, should an individual be selected for
testing under proposed Sec. 26.65(e)(2)(i). The licensee or other
entity would complete an alcohol test and collect a specimen for drug
testing before reinstating the individual's authorization. In order to
maintain the individual's reinstated authorization, the proposed rule
would require that the licensee or other entity must receive negative
drug test results within 5 days after reinstatement or administratively
withdraw the individual's authorization until negative drug test
results are received. However, proposed Sec. 26.65(e)(3) would permit
licensees and other entities to forego subjecting an individual to the
possibility of being selected for pre-access testing, if the applicant
had been subject to the drug and alcohol testing (including random
testing), behavioral observation, and arrest-reporting elements of a
Part 26 FFD program throughout the interruption in the individual's
authorization; because being subject to these program elements during
the interruption period would be sufficient to deter substance abuse
and provide assurance that substance abuse would be detected. Proposed
Sec. 26.65 would enhance the deterrent effect of pre-access testing
for individuals who have had a very short break in authorization,
without imposing the burden of requiring that every individual must be
tested.
Proposed Sec. 26.65(f) [Time period for testing] would be added to
require that specimens that are collected for any pre-access testing
required in this proposed section must be collected within the 30-day
period preceding the day upon which the licensee grants authorization
to an individual. Under current Sec. 26.24(a)(1), licensees and other
entities are permitted to complete pre-access testing within the 60-day
period before authorization is granted. The shorter time period within
which pre-access testing must be conducted, if required, in the
proposed rule would increase the likelihood of detecting an active
substance abuse problem among applicants for unescorted access to
nuclear power plants and others who are subject to Part 26 by
increasing the number of pre-access tests that would be performed. In
addition, the decreased time period for pre-access testing would
increase the likelihood that recent drug use, particularly marijuana,
would be detected before the concentration of metabolites in an
individual's body could decrease below the cutoff levels prescribed in
the proposed rule. The decreased time period within which pre-access
testing must be performed in the proposed rule would provide higher
assurance that individuals subject to this part are trustworthy and
reliable, as demonstrated by the avoidance of substance abuse, as
discussed with respect to proposed Sec. 26.23(a).
Proposed Sec. 26.65(g) [Administrative withdrawal of
authorization] would be added to ensure that the licensee or other
entity does not record or report as an unfavorable termination any
administrative withdrawal of authorization that may be required under
proposed paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this proposed
section. The point in time at which a licensee or other entity receives
drug test results would not be under the control of the applicant and
would not reflect upon the applicant's fitness, trustworthiness, or
reliability, if the licensee or other entity is unable to obtain drug
test results within the 5 days permitted and must administratively
withdraw the individual's authorization. Therefore, subjecting the
individual to the severe consequences associated with a record of an
unfavorable termination would be inappropriate. Should the drug test
results be non-negative and the licensee or other entity terminates the
individual's authorization for cause, however, the termination would
then be recorded as unfavorable.
Proposed Sec. 26.65(h) [Sanctions for a confirmed non-negative
pre-access test result] would be added to specify the minimum sanctions
to be imposed on an individual whose pre-access test results are
confirmed by the MRO as an FFD policy violation. Proposed Sec.
26.65(h)(1) and (h)(2) would cross-reference the relevant sanctions
specified in proposed Subpart D [Management Actions and Sanctions] to
clarify that those sanctions would apply to applicants for
authorization. For example, if the MRO determines that an individual
has submitted an adulterated urine specimen for a pre-access drug test,
the licensee or other entity would be required to impose the sanction
for an attempt to subvert the testing process (i.e., permanent denial
of authorization) in proposed Sec. 26.75(b).
Proposed Sec. 26.65(h)(3) would be added to permit licensees and
other entities to grant authorization to an individual whose confirmed
non-negative test result is a first drug- or alcohol-related violation
under a Part 26 program, consistent with current Sec. 26.27(b)(2).
However, the proposed rule would permit authorization to be granted
only in accordance with the stringent requirements contained in
proposed Sec. 26.69 [Authorization with potentially disqualifying
fitness-for-duty information].
Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have
Applied for Authorization
A new Sec. 26.67 [Random drug and alcohol testing of individuals
who have applied for authorization] would be added to extend current
random testing requirements to individuals who have applied for
authorization under Part 26 but to whom authorization has not yet been
granted. The requirements contained the proposed section would be added
to the access authorization requirements that were established by
orders to nuclear power plant licensees dated January 7, 2003, for two
reasons: (1) To enhance the effectiveness of FFD programs by increasing
the likelihood that substance abuse would be detected before
authorization is granted, and (2) to deter the potential for substance
abuse among applicants.
A new Sec. 26.67(a) would require licensees and other entities to
conduct random testing of applicants in accordance with the
requirements of proposed Sec. 26.31(d)(2). That is, the licensee or
other entity would add applicants to the FFD program's normal
population of individuals who are subject to random testing, select
individuals for testing at the 50 percent annual rate, and otherwise
subject applicants to the same random testing requirements as
individuals who currently hold authorization under Part 26. An
applicant would be subject to random testing beginning when the
licensee or other entity collects the specimens for any required pre-
access test, and continuing thereafter, if the licensee or other entity
grants authorization to the individual.
Licensees and other entities would be permitted to forego random
testing of applicants in the two circumstances described in proposed
Sec. 26.67(a)(1) and (a)(2). Proposed Sec. 26.67(a)(1) would permit a
licensee or other entity to discontinue random testing of any applicant
to whom the licensee or other entity does not grant authorization for
[[Page 50510]]
any reason, including a termination or denial of authorization or a
withdrawal of the application for authorization by the individual or
the individual's employer, in the case of a C/V. Proposed Sec.
26.67(a)(2) would address the circumstance described in proposed Sec.
26.65(b), in which the licensee or other entity is permitted to meet
pre-access testing requirements by relying upon negative test results
from specimens collected under another Part 26 program within 30 days
before granting authorization to the individual. Under proposed Sec.
26.67(a)(2), the licensee or other entity would begin subjecting the
applicant to random testing when the licensee or other entity takes the
first formal action to process the individual's application for
authorization. The actions may include, but are not limited to, the
point in time at which the licensee or other entity receives the
individual's signed consent form and begins creating a record of the
individual's application that would be accessible to other licensees
and entities; conducts a psychological evaluation; begins a suitable
inquiry; or takes other actions that are required under NRC regulations
to grant authorization. The first formal action that the licensee or
other entity takes to process an individual's application for
authorization will vary, depending upon the licensee's FFD and access
authorization program procedures, whether the applicant's FFD training
is up-to-date, and other factors, which, together, make it impractical
to establish in the proposed rule a single point in the authorization
process at which random testing must begin. Therefore, the proposed
paragraph would require the licensee or other entity to begin
subjecting the individual to random testing when the licensee or other
entity takes the first formal action, but would not define a specific
formal action that would initiate random testing of applicants in all
cases.
Proposed Sec. 26.67(b) would be added to permit licensees and
other entities to grant authorization to an individual before random
testing is completed, if the individual has met all of the requirements
for authorization but has been selected for one or more random tests
while in applicant status. That is, if the applicant has met all other
applicable requirements for authorization, licensees and other entities
need not delay granting authorization to the individual in order to
conduct and obtain the results from a random test, if the applicant was
selected for random testing while in applicant status. The proposed
rule would not require the testing to be completed before the licensee
or other entity grants authorization to the individual because the
primary purpose of random testing of applicants would be to deter
substance abuse rather than to provide information for the
authorization decision. Pre-access testing provides the necessary
information for authorization decision-making.
Proposed Sec. 26.67(c) would cross-reference the minimum sanctions
to be imposed on an individual whose drug or alcohol test results from
random testing are confirmed as non-negative. Proposed Sec.
26.67(c)(1) and (c)(2) would refer to the relevant sanctions specified
in proposed Subpart D. Proposed Sec. 26.67(c)(3) would continue to
permit licensees and other entities to grant authorization to an
individual whose confirmed non-negative test result is a first drug- or
alcohol-related violation under a Part 26 program, consistent with
current Sec. 26.27(b)(2), but the proposed rule would permit
authorization to be granted only in accordance with the stringent
requirements contained in proposed Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information].
Section 26.69 Authorization With Potentially Disqualifying Fitness-for-
Duty Information
A new Sec. 26.69 [Authorization with potentially disqualifying
fitness-for-duty information] would replace and clarify the existing
requirements contained in Sec. 26.27(b)(4), which establishes
requirements for granting authorization to an individual who has
violated an FFD policy and had his or her authorization terminated
unfavorably or denied for a period of 3 or 5 years under the current
rule. Consistent with Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule, the proposed
section would be added to address problems that have arisen in
implementing the current rule and clarify the NRC's intent with respect
to several situations that are not addressed in the current rule.
Proposed Sec. 26.69(a) [Purpose] would be added to describe the
purpose of the section and the applicants to whom the requirements in
the proposed section would apply. The proposed rule would require
licensees and other entities to meet the applicable requirements in
this section before granting authorization to an individual or
permitting an individual to maintain his or her authorization when
potentially disqualifying FFD information is obtained about an
individual through any means and the information has not been assessed
and favorably resolved by a previous licensee or other entity. Proposed
Sec. 26.63(b) would permit licensees and other entities to rely upon
the results of determinations of fitness that were conducted by
previous licensees or other entities, rather than requiring each new
licensee or other entity to reevaluate the same information that was
reviewed and resolved under another Part 26 program. However, if the
potentially disqualifying FFD information was not previously reviewed
and favorably resolved under another Part 26 program, licensees and
other entities would implement the requirements contained in this
proposed section.
The proposed paragraph would also revise the language contained in
current Sec. 26.27(b)(2) to recognize that licensees and other
entities may decide not to grant authorization to the subject
individual and so, in that case, would not be required to implement
these requirements. At the public meetings discussed in Section V,
stakeholders noted that some individuals have misinterpreted the
current rule as requiring licensees to provide individuals who have
violated an FFD policy with the opportunity to seek treatment for a
substance abuse problem and to have authorization reinstated. However,
although the NRC continues to affirm that individuals who pursue
treatment and maintain sobriety may be considered for authorization,
both the current and proposed rules assign the responsibility for
making authorization decisions to the licensee or other entity.
Therefore, the proposed paragraph would clarify that granting or
maintaining the authorization of an individual about whom potentially
disqualifying FFD information has been disclosed or discovered is ``at
the licensee's or other entity's discretion.''
Proposed Sec. 26.69(b) [Authorization after a first confirmed
positive drug or alcohol test result or a 5-year denial of
authorization] would be added to define requirements for granting
authorization, at the licensee's or other entity's discretion, to an
individual who had confirmed positive drug or alcohol test results and
whose authorization, as a result, was previously terminated unfavorably
or denied for 5 years. The requirements in the proposed paragraph would
apply to: (1) An applicant who had a first confirmed positive test
result on a pre-access test and was consequently denied authorization
by a licensee; (2) an individual who is returning to duty following the
14-day assessment period required in current Sec. 26.26(b)(2), which
would be moved to
[[Page 50511]]
proposed Sec. 26.75(e)(1); (3) an individual whose authorization was
terminated unfavorably under another Part 26 program and who had an
interruption in authorization that was longer than 14 days; and (4) an
individual whose authorization was denied for 5 years under the
requirements of proposed Sec. 26.75(c), (d), (e)(2), or (f). The
proposed paragraph would replace and strengthen the requirements
contained in current Sec. 26.27(b)(2) and expand them to address
confirmed positive alcohol test results, which are excluded from this
process in current Sec. 26.27(b)(5). The proposed paragraph would
include confirmed positive alcohol test results for the reasons
discussed with respect to proposed Sec. 26.75(e).
Proposed Sec. 26.69(b)(1) would require the licensee or other
entity to obtain and review a self-disclosure from the applicant to
verify that it does not contain any previously undisclosed potentially
disqualifying FFD information. Because the individual's last period of
authorization was terminated unfavorably or denied, licensees and other
entities would not be permitted to forego obtaining a self-disclosure
and employment history under any circumstances, because it would be
important to review the individual's activities during the interruption
period. The period of time to be addressed in the self-disclosure would
be the shorter of either the past 5 years or the intervening period
since the individual last held authorization.
Proposed Sec. 26.69(b)(2) would increase the scope of the suitable
inquiry that the licensee or other entity must conduct by requiring the
licensee or other entity to conduct the suitable inquiry with every
employer by whom the applicant claims to have been employed during the
period of time addressed in the individual's self-disclosure. This
extensive suitable inquiry would be necessary to determine whether any
indications exist that the individual has continued to engage in
substance abuse. The proposed rule would also required licensees and
other entities to obtain and review any records that other licensees or
entities may have developed related to any potentially disqualifying
FFD information about the individual from the past 5 years. These
records may include, but would not be limited to, the results of past
suitable inquiries or other investigations, records of arrests or
convictions, drug and alcohol test results, treatment records, and the
results of determinations of fitness. This information would be used by
the SAE to assess the individual's fitness and the licensee's or other
entity's reviewing official to determine whether authorization is
warranted.
Proposed Sec. 26.69(b)(3) would apply only to individuals whose
authorization was denied for 5 years under the current rule or in
accordance with Sec. 26.75(c), (d), (e)(2), or (f) of the proposed
rule. The proposed paragraph would require the licensee or other entity
to verify, before granting authorization, that the individual had not
abused alcohol or drugs during the 5-year interruption, at a minimum.
The proposed requirement would be consistent with the portion of
current Sec. 26.27(b)(4) that requires licensees to obtain
``satisfactory medical assurance that the person has abstained from
drugs for at least three years.'' However, the proposed rule would
extend the requirement to 5 years to ensure that such an individual
would be at the lowest risk of recidivism into an active substance
abuse problem before the licensee or other entity could grant
authorization to the individual.
Proposed Sec. 26.69(b)(4) would amend the requirement in current
Sec. 26.27(b)(2), which mandates that an individual who has a first
confirmed positive test result must be referred to the EAP for
assessment and counseling before the licensee or other entity may grant
authorization to the individual. The proposed paragraph would make
several changes to the current provision. First, the proposed rule
would replace the term, ``management and medical assurance of
fitness,'' which is used in current Sec. 26.27(b)(2) and (b)(4), with
the term, ``determination of fitness,'' to improve the accuracy of the
language in the proposed rule. The proposed rule would not use
``management'' because the licensee's or other entity's reviewing
official (see the discussion of proposed Sec. 26.69(c)(3) and the
definition of ``reviewing official'' in proposed Sec. 26.5
[Definitions]) is the individual who licensees and other entities
currently designate to make authorization decisions and the reviewing
official may not be a manager. In addition, the proposed rule would
permit professionals other than a licensed physician to conduct a
determination of fitness, for the reasons discussed with respect to
proposed Sec. 26.189 [Determination of fitness]. Therefore, this
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule.
Consistent with the intent of the current requirement, the proposed
paragraph would require the licensee or other entity to ensure that a
``determination of fitness'' is conducted, as defined in proposed Sec.
26.189 [Determination of fitness], as part of the authorization
decision. Proposed Sec. 26.187 [Substance abuse expert] would require
that determinations of fitness that are conducted for authorization
decisions must be performed by an SAE, whose role, responsibilities,
and required qualifications would also be defined in proposed Sec.
26.187. Therefore, proposed Sec. 26.69(b)(4) would require that the
individual must be referred to an SAE for a determination of fitness,
but the proposed rule would not require the SAE to be an EAP employee.
Permitting licensees and other entities to rely upon a professional who
meets the required qualifications for an SAE, rather than only on EAP
personnel, would more appropriately focus this requirement on assuring
that the professional who performs the assessment and treatment
planning is qualified, rather than on the professional's organizational
affiliation.
Proposed Sec. 26.69(b)(4)(i)-(b)(4)(iii) would replace and
strengthen the requirement in current Sec. 26.27(b)(2), which states
that ``any rehabilitation program deemed appropriate must be initiated
during such suspension period.'' The proposed paragraph would require
that the individual must be in compliance with or have successfully
completed treatment plans, rather than simply started treatment, in
order for the licensee or other entity to grant authorization to the
individual and maintain the individual's authorization after it has
been granted.
Proposed Sec. 26.69(b)(5) would be added to impose more stringent
pre-access testing requirements on an individual who is being
considered for authorization following an unfavorable termination or
denial of authorization than those required for individuals whose last
period of authorization was terminated favorably. The proposed
paragraph would require negative results from an alcohol test performed
within 10 business days before authorization is granted. Similarly, the
proposed paragraph would require negative results from a urine specimen
that was collected for drug testing within 10 business days before
authorization is granted, as well as collection of the urine specimen
under direct observation. The proposed paragraph would prohibit the
licensee or other entity from granting authorization to the individual
before the drug test results are reported to the licensee's or other
entity's MRO so that the MRO may determine whether the drug test
results indicated that the individual has not engaged in any further
drug abuse [see the discussion of proposed Sec. 26.69(f)]. Completing
drug and alcohol testing within 10 days
[[Page 50512]]
before granting authorization, rather than the 30 days that is
permitted in proposed Sec. 26.65(f) [Time period for testing] for the
other authorization categories, would provide evidence that the
individual has abstained from abusing proscribed substances during the
interruption period and that the individual would be able to safely and
competently perform duties under this part when authorization is
reinstated, if the individual's authorization has been interrupted for
the 14-day assessment period required under current Sec. 26.27(b)(2)
and retained in proposed Sec. 26.75(e)(1). Requiring direct
observation of the urine specimen collection would be necessary to
provide added assurance that the specimen is valid and yields accurate
drug test results.
Proposed Sec. 26.69(b)(6) would apply only to individuals whose
authorization has been unfavorably terminated or denied for at least 14
days for a first confirmed positive drug or alcohol test result. The
proposed paragraph would replace the third sentence of current Sec.
26.27(b)(4), which establishes requirements and a schedule for followup
drug and alcohol testing for an individual whose authorization was
denied for 3 years under the current rule, and apply the requirement
for followup testing to individuals who have had a first confirmed
positive test result for drugs or alcohol. The proposed requirement
would provide greater deterrence of further drug and alcohol use than
current Sec. 26.27(b)(4), which requires this followup testing only
for the more serious FFD violations that result in a denial of
authorization for 3 years or longer. The more stringent requirement
would provide higher assurance that individuals who are subject to this
part are trustworthy, reliable, and fit for duty.
Proposed Sec. 26.69(b)(6) would amend the current fixed schedule
for followup testing by requiring licensees and other entities to
subject the individual to the possibility of being selected for
followup testing, during any period in which he or she holds
authorization under Part 26, for a period of 3 calendar years after the
individual's authorization is restored following termination or denial
for the first confirmed positive drug or alcohol test result. The
proposed rule would require licensees and other entities to ensure that
the individual is subject to unannounced testing at least 15 times
within the 3-year period and verify that the individual's test results
are negative. Either random or followup tests, which are both
unannounced, may be used to meet this proposed requirement. The
proposed rule would require licensees and other entities to distribute
the unannounced tests over the 3-year period, with at least one
unannounced test conducted each quarter.
Proposed Sec. 26.69(b)(6)(i)-(b)(6)(iii) would be added to address
circumstances in which an individual is not continuously subject to a
Part 26 program during the 3 years following restoration of
authorization. Proposed Sec. 26.69(b)(6)(i) would require that an
individual who intermittently holds authorization over the 3-year
period must be subject to unannounced testing at least once in each
quarter during which the individual is authorized. Proposed Sec.
26.69(b)(6)(ii) would permit the licensee or other entity to extend the
followup testing period to 5 years, if the requirement for 15 tests
over the 3-year period has not been met because the individual has not
been authorized a sufficient number of times or for sufficient periods
of time during the first 3 years to meet the proposed 15-test
requirement. Proposed Sec. 26.69(b)(6)(iii) would permit the licensee
or other entity to have an SAE conduct a determination of fitness to
determine whether further followup testing is required, if an
individual is unable to meet the 15-test requirement after 5 years due
to brief and infrequent periods of authorization.
These proposed changes to the current followup testing requirements
respond to information provided by stakeholders in the public meetings
discussed in Section V. Stakeholders reported that some individuals who
are subject to followup testing have been unable to satisfy the
requirements of current Sec. 26.27(b)(4) because they are not
continuously employed in the nuclear industry in job positions that
require authorization, and, therefore, are not continuously subject to
a Part 26 FFD program. As a result, these individuals have been unable
to demonstrate negative test results on tests that are performed ``once
every month for four months and at least once every three months for
the next two years and eight months after unescorted access is
reinstated.'' Stakeholders reported that some individuals have been
unable to satisfy the current requirement after 10 years, despite
obtaining negative test results on every pre-access, random, and
followup test administered during that period, because the individuals
were not continuously subject to a Part 26 followup testing program for
the required 3-year period. This was not the intent of the current
provision. Therefore, the proposed revision to this requirement would
increase the flexibility with which licensees and other entities may
implement followup testing requirements, but retain the current
effectiveness of followup testing in detecting and deterring substance
abuse.
Proposed Sec. 26.69(b)(7) would be added to require the licensee
or other entity to verify that the results of all drug and alcohol
tests that are administered to the individual under a Part 26 program
following restoration of the individual's authorization indicate no
further drug or alcohol abuse. The proposed paragraph would not specify
that the drug test results must be negative, because the metabolites of
some drugs, such as marijuana, may be present in an individual's urine
for several weeks after the individual has stopped using the drug. If
an individual is tested again soon after the original test that
resulted in an FFD violation was conducted, the specimen may yield
positive results which would not, in fact, reflect new drug use.
Therefore, if subsequent drug test results show the presence of the
same drug or drug metabolites in the individual's urine as detected in
the original confirmed positive test result, the MRO, under proposed
Sec. 26.185(o), would be required to determine whether the results
indicate new drug use or are consistent with results that would be
expected from the drug use that resulted in the previous confirmed
positive test result. The proposed rule would add this requirement in
response to inconsistencies in the manner in which some MROs have
implemented current requirements related to return-to-duty drug
testing. Some MROs have been inappropriately reluctant to declare a
second drug test result as negative if any concentration of the drug or
drug metabolites that resulted in a first confirmed positive drug test
result are detected in the specimen. The proposed change would permit
an individual who has not engaged in further drug use after a first
confirmed positive drug test result to regain authorization, at the
licensee's discretion, rather than be incorrectly denied authorization
for 5 years on the basis of a subsequent FFD policy violation, under
proposed Sec. 26.75(e)(2).
Proposed Sec. 26.69(c) [Granting authorization with other
potentially disqualifying FFD information] would be added to establish
requirements for granting authorization to an individual about whom
potentially disqualifying FFD information is discovered or disclosed
that was not a confirmed non-negative drug or alcohol test result or 5-
year denial of authorization. For example, this type of potentially
[[Page 50513]]
disqualifying FFD information may include, but would not be limited to:
(1) A report of an arrest for an alcohol-related traffic violation; (2)
information from the suitable inquiry that an individual's employment
was terminated by a previous private-sector employer because of drug-
or alcohol-related job performance problems; or (3) information
obtained from the suitable inquiry or other sources of information
indicating that the individual is known to abuse illegal drugs or
alcohol or is experiencing significant mental or emotional stress. The
proposed paragraph would be necessary because the current rule does not
address the authorization process in such circumstances and the NRC is
aware that licensees and other entities have handled these
circumstances inconsistently. Therefore, the proposed rule would add
these requirements to establish the NRC's intent with respect to these
circumstances and increase consistency between Part 26 programs.
Proposed Sec. 26.69(c)(1) would be added to require the licensee
or other entity to verify that the individual's self-disclosure
addresses the applicable period specified in proposed Sec.
26.61(b)(3). The proposed rule would not require the licensee or other
entity to ``obtain'' a self-disclosure in all circumstances, because
the individual may have already provided a self-disclosure under
proposed Sec. Sec. 26.55, 26.57, or 26.59 and an additional self-
disclosure and employment history would be unnecessary.
Proposed Sec. 26.69(c)(2) would require the licensee or other
entity to conduct a suitable inquiry with every employer for the period
that would be addressed in the self-disclosure and employment history.
If the potentially disqualifying FFD information was identified during
the course of conducting a suitable inquiry in accordance with proposed
Sec. 26.63(f) so that the suitable inquiry was partially completed,
proposed Sec. 26.69(c)(3) would require the licensee or other entity
to conduct a more complete suitable inquiry by contacting every
employer that the individual listed during the interruption period. The
proposed paragraph would also require the licensee or entity to obtain
and review any records that other licensees or entities who are subject
to this part may have developed with regard to potentially
disqualifying FFD information about the individual from the past 5
years. This more complete suitable inquiry would be necessary to ensure
that the licensee or other entity has more information about the
individual than is required for individuals whose last period of
authorization was terminated favorably in order to make an appropriate
authorization decision.
Proposed Sec. 26.69(c)(3) would be added and would use the term,
``reviewing official,'' to refer to the employee who is designated by
the licensee or other entity to make authorization decisions, as
discussed with respect to proposed Sec. 26.5 [Definitions]. The
proposed paragraph would permit the reviewing official to grant or deny
authorization, based upon his or her review of the circumstances
associated with the potentially disqualifying FFD information. Because
of the variety of circumstances that may arise, the proposed paragraph
also would grant discretion to the reviewing official in deciding
whether a determination of fitness is required, rather than requiring a
determination of fitness in every case. However, if the reviewing
official requests a determination of fitness and the professional who
performs it recommends any form of treatment or drug and alcohol
testing, including the collection of urine specimens under direct
observation, proposed Sec. 26.69(c)(4) would require the licensee or
other entity to implement the treatment and testing recommendations.
Proposed Sec. 26.69(c)(5) would be added to require pre-access and
random testing of the applicant for authorization. The proposed
paragraph would require the licensee or other entity to verify that the
results of pre-access drug and alcohol tests are negative before
granting authorization to the individual. The proposed rule would
require the licensee or other entity to verify that test results are
negative before granting authorization to the individual to provide
evidence that the individual is avoiding substance abuse.
Proposed Sec. 26.69(d) [Maintaining authorization with other
potentially disqualifying FFD information] would be added to establish
requirements for maintaining an individual's authorization when new
potentially disqualifying FFD information is disclosed or discovered
that was not a confirmed non-negative drug or alcohol test result or 5-
year denial of authorization, if the reviewing official determines that
maintaining authorization is warranted. A self-disclosure, suitable
inquiry, and pre-access testing would not be required because the
individual would not be applying for authorization. However, the
proposed paragraph would require the reviewing official to review the
circumstances related to the information, and, at his or her
discretion, ensure that a professional with the appropriate
qualifications makes a determination of fitness. The proposed paragraph
would require the licensee or other entity to implement any treatment
or testing requirements resulting from the determination of fitness.
The proposed paragraph would be added because the current rule does not
address maintaining an individual's authorization in such circumstances
and the NRC is aware that licensees and other entities have handled
these circumstances inconsistently. Therefore, the proposed rule would
add these requirements to establish the NRC's intent with respect to
these circumstances and increase consistency between Part 26 programs.
A new Sec. 26.69(e) [Accepting followup testing and treatment from
another Part 26 program] would establish continuity of care
requirements for individuals who were subject to a followup testing and
substance abuse treatment plan under one Part 26 program and transfer
to another FFD program or leave and then return to the same FFD
program. The proposed paragraph would require the receiving licensee
other entity to continue the testing and treatment plan to which the
individual was subject under the previous FFD program. The proposed
rule would also permit the receiving licensee or other entity to accept
and rely upon any followup testing that was completed while the
individual was subject to the previous Part 26 program in determining
how long followup testing must continue. For example, if an individual
met all of the requirements for authorization by a new licensee, but
had completed only 2 of the 3 years of followup testing required under
a previous Part 26 program, then the granting licensee would administer
the final year of the followup testing, but would not be required to
``re-start the clock'' and conduct another 3 full years of followup
testing after the individual was authorized. If the transferring
individual successfully completed any followup testing and treatment
program required under the first FFD program, a previous determination
of fitness indicated that the individual is fit for duty, and the
individual's authorization by the first licensee or other entity was
terminated favorably, then the proposed paragraph would permit the
receiving licensee or other entity to accept the previous determination
of fitness and would not require the granting licensee to develop and
implement an additional testing and treatment plan.
Proposed Sec. 26.69(f) [Sanctions for confirmed non-negative drug
and alcohol test results] would be added to
[[Page 50514]]
clarify the minimum sanctions to be imposed on an individual who has
confirmed non-negative drug and alcohol test results on any tests that
may be required under this proposed section. Proposed Sec. 26.69(f)(1)
and (f)(2) would cross-reference the relevant sanctions specified in
proposed Subpart D [Management actions and sanctions] to establish that
those sanctions would apply to individuals about whom potentially
disqualifying FFD information has been discovered or disclosed.
Section 26.71 Maintaining Authorization
Proposed Sec. 26.71 [Maintaining authorization] would be added to
state the requirements for maintaining authorization under this part.
The proposed section would respond to stakeholder requests for this
clarification at the public meetings discussed in Section V.
Proposed Sec. 26.71(a) would provide that individuals may maintain
authorization under the conditions listed in proposed Sec.
26.71(a)(1)-(a)(4), as follows:
Proposed Sec. 26.71(a)(1) would establish that an individual must
comply with the licensee's or other entity's FFD policies to which the
individual is subject. This proposed requirement thus relates, although
it does not refer, to proposed Sec. 26.27 [Written policy and
procedures], which would require the licensee or other entity to
prepare a clear and concise statement of its FFD policy and make that
policy readily available to all individuals who are subject to it. The
proposed rule would require that all individuals who are subject to the
FFD policy must have information on what is expected of them and what
consequences may result from a lack of adherence to the policy.
Proposed Sec. 26.71 would also require that, in order to maintain
authorization, an individual must report any legal actions, as defined
in proposed Sec. 26.5 [Definitions]. Finally, although not explicitly
specified in proposed Sec. 26.71(a)(1), proposed Sec. 26.33
[Behavioral observation] would require individuals to report any FFD
concern to the personnel designated in the FFD policy.
Proposed Sec. 26.71(a)(2) would establish that an individual may
maintain authorization if the individual remains subject to a drug and
alcohol testing program that complies with the requirements of Part 26,
including random testing. Licensees and other entities who are subject
to Part 26 are responsible for implementing drug and alcohol testing
programs that comply with the requirements in proposed Sec. 26.31
[Drug and alcohol testing], and the failure of a licensee or other
entity to maintain a program would terminate the authorizations of
individuals who have been granted authorization by the licensee or
other entity. [See the discussion of Sec. 26.71(b).] In addition,
proposed Sec. 26.31 also would place certain responsibilities on
individuals who are subject to the testing program. In particular,
under proposed Sec. 26.31(d)(2)(iii), individuals who are selected for
random testing would be required to report to the collection site as
soon as reasonably practicable after notification, and within the time
period specified in FFD program procedures, as well as to cooperate in
the testing process. In appropriate circumstances, an individual's
failure to report or cooperate could be the basis for terminating the
individual's authorization.
Proposed Sec. 26.71(a)(3) would establish that an individual may
maintain authorization if the individual remains subject to a
behavioral observation program that complies with the requirements of
Part 26. Behavioral observation, as required by proposed Sec. 26.33
[Behavioral observation], would be performed by individuals, including
coworkers, who have been trained to detect behaviors that may indicate
possible use, sale, or possession of illegal drugs; use or possession
of alcohol on site or while on duty; or impairment from fatigue or any
cause that, if left unattended, might constitute a threat to the health
and safety of the public or the common defense and security.
Proposed Sec. 26.71(a)(4) would establish that a condition for
maintaining authorization is successful completion by the individual of
required FFD training, according to the schedule in proposed Sec.
26.29(c). As specified in proposed Sec. 26.29(c)(1), the proposed rule
would require the individual to complete training before the licensee
or other entity grants initial authorization. Thereafter, as specified
in proposed Sec. 26.29(c)(2), the proposed rule would require
individuals to complete refresher training or pass a comprehensive
examination on a nominal 12-month frequency. Proposed Sec. 26.29(d)
would provide that licensees and other entities may accept training of
individuals who have been subject to another Part 26 program and have,
within the past 12 months, either had initial or refresher training or
successfully passed a comprehensive examination that meets the
requirements of proposed Sec. 26.29.
Proposed Sec. 26.29(d) would require a licensee or other entity to
terminate an individual's authorization if the individual, for more
than 30 [consecutive] days, is not subject to an FFD program that meets
the requirements of Part 26. The requirements of the proposed paragraph
would permit an individual to be away from all elements of a Part 26
program for this period of time in order to accommodate vacations and
significant illnesses when the individual would not be reasonably
available for behavioral observation or to collect specimens for random
drug and alcohol testing. The proposed paragraph would be added in
response to stakeholder requests and would be consistent with related
requirements in the access authorization orders issued to nuclear power
plant licensees on January 7, 2003.
Subpart D--Management Actions and Sanctions
Section 26.75 Sanctions
The first sentence of proposed Sec. 26.75(a) would introduce the
purpose of the section, which would be to define the minimum sanctions
that licensees and other entities must impose when an individual has
violated the drug and alcohol provisions of an FFD policy. The second
sentence of the proposed paragraph would restate the second sentence of
current Sec. 26.27(b), which permits licensees and other entities to
impose more stringent sanctions than those specified in the rule. The
proposed rule would add a reference to paragraph (h) of the proposed
section, which would establish limits on the sanctions that licensees
and other entities may impose for non-negative validity and drug test
results, to clarify that there is one exception to the blanket
permission to impose more stringent sanctions granted in this
paragraph, as discussed with respect to proposed paragraph (h) of this
section. These proposed changes would be made to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.75(b) would be added to require licensees and
other entities to permanently deny authorization to individuals who
refuse to be tested or who in any way subvert or attempt to subvert the
testing process. The proposed sanction is necessary because acts to
subvert the testing process reflect a sufficiently egregious lack of
trustworthiness and reliability to warrant permanent denial of
authorization. An individual's willingness to subvert or attempt to
subvert the testing process provides
[[Page 50515]]
strong evidence that the individual will also be willing to disregard
other rules and regulations, such as safeguards requirements, which
ensure the protection of public health and safety and the common
defense and security. In addition, if an individual succeeds in
subverting the testing process in order to hide substance abuse, the
individual may pose an undetected and unacceptable risk to public
health and safety or the common defense and security by performing the
duties that require him or her to be subject to this part while
impaired. Therefore, the proposed change would be made to meet Goal 3
of this rulemaking, which is to improve the effectiveness of FFD
programs, by deterring acts to defeat the testing process as well as
preventing any individuals who engage in them from posing any further
risk to public health and safety and the common defense and security.
The proposed rule would specify three examples of actions that
would be considered subversion or an attempt to subvert the testing
process. These include refusing to provide a specimen and providing or
attempting to provide a substituted or adulterated specimen. However,
these examples are not intended to be exhaustive. For example, if a
licensee or other entity determines that several individuals had
colluded to notify potential donors that they would be selected for
random testing on a particular day, so that the potential donors could
plan to avoid work on that day or take other actions to ensure that
their illegal drug use would not be detected, the NRC would expect the
licensee or other entity to permanently deny authorization to all of
the individuals who were involved in the collusion.
The proposed rule would not include submitting a dilute specimen as
an example of a subversion attempt without additional evidence that the
donor had diluted the specimen in order to mask the presence of drugs
or drug metabolites in the specimen, for the reasons discussed with
respect to proposed Sec. 26.185(g). Submitting a dilute specimen, in
itself, would not necessarily indicate an attempt to subvert the
testing process because there are many legitimate causes for a dilute
specimen, including drinking liquids in order to provide a specimen of
sufficient quantity, as permitted in Section 2.4(g)(11) in Appendix A
of the current rule and in proposed Sec. 26.109(b)(1). Therefore, the
proposed rule would not require licensees and other entities to apply
the sanction of permanent denial of authorization for submitting a
dilute specimen, unless there is other evidence that the donor had
diluted the specimen in an attempt to subvert the testing process.
The phrase, ``for any test required under this part,'' would be
added to proposed Sec. 26.75(b) to indicate that applicants for
authorization who subvert or attempt to subvert a pre-access or random
test would also be subject to permanent denial of authorization.
Although these individuals would not yet be performing any job duties
that could affect public health and safety or the common defense and
security, an attempt to subvert the testing process while in an
applicant status provides strong evidence that the individual cannot be
trusted to perform those job duties. Therefore, it is necessary to
ensure that any applicant who subverts or attempts to subvert the
testing process would be denied authorization.
Proposed Sec. 26.75(c) would amend current Sec. 26.27(b)(3),
which establishes sanctions for the sale, use, or possession of illegal
drugs within a protected area of any nuclear power plant, within a
facility that is licensed to possess or use formula quantities of SSNM,
or within a transporter's facility or vehicle. The proposed paragraph
would retain the current sanction of a 5-year denial of authorization
in these instances and add two other instances in which a 5-year denial
of authorization would be required.
First, the proposed rule would require licensees and other entities
to impose a 5-year denial of authorization on any individual who is
determined to have consumed alcohol within a protected area of any
nuclear power plant, within a facility that is licensed to possess or
use formula quantities of SSNM, or within a transporter's facility or
vehicle. This proposed change is necessary because consuming alcohol
causes impairment, which poses the same risks to public health and
safety as impairment from illegal drugs. Extending the scope of the
current sanction to alcohol consumption also would be consistent with
the revised FFD program performance objective in proposed Sec.
26.23(d), which is to provide reasonable assurance that the workplaces
subject to this part are free from the presence and effects of alcohol
as well as illegal drugs. Therefore, the proposed change would be made
to meet Goal 3 of this rulemaking, which is to improve the
effectiveness of FFD programs, by reducing the risk to public health
and safety and the common defense and security that on-site use of
alcohol poses.
Second, the proposed rule would add the phrase, ``or while
performing the job duties that require the individual to be subject to
this part,'' to address circumstances in which an individual may be
performing job duties that require him or her to be subject to this
part but is not performing those duties within the protected area of a
nuclear power plant, within a facility that is licensed to possess or
use formula quantities of SSNM, or within a transporter's facility or
vehicle. As one example, many nuclear power plant licensees' designated
collection sites are located outside of the plant's protected area. The
intent of the current rule is to prohibit the presence, sale, and use
of alcohol or illegal drugs by FFD program personnel at a collection
site that is located outside of the protected area, but the current
rule does not specifically address such circumstances. The majority of
licensees have appropriately interpreted the intent of the current
rule, but the proposed rule would add this phrase to meet Goal 6 of
this rulemaking, which is to improve clarity in the organization and
language of the rule.
In addition, the list of activities in the current paragraph that
an individual would be prohibited from performing would be deleted in
the proposed paragraph and replaced with the summary term,
``authorization,'' for consistency with the use of this term throughout
the proposed rule. As discussed with respect to proposed Sec. 26.25
[Individuals subject to the fitness-for-duty program], the list of job
duties that require individuals to maintain authorization and to be
subject to this part would be presented once in proposed Sec. 26.25,
rather than repeatedly throughout the rule, for consistency with Goal 6
of this rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.75(d) would amend the portion of current Sec.
26.27(c) that requires licensees to record as a removal ``for cause''
an individual's resignation that occurs before the licensee ``removes''
the individual for violating the FFD policy. This portion of the
current provision has raised implementation questions from licensees
regarding the appropriate action to take in these circumstances.
Licensees have questioned whether the intent of the current requirement
is to deny authorization to an individual for some period of time, as
required under current Sec. 26.27(b)(2)-(b)(4), permanently deny
authorization to the individual, or merely to record the resignation.
Therefore, the proposed rule would clarify the intent of the current
provision, as follows:
[[Page 50516]]
The proposed rule would establish the sanction of a 5-year denial
of authorization for an individual who resigns before a licensee or
other entity terminates the individual's authorization or denies
authorization to an applicant for a first violation of the FFD policy
involving a confirmed positive drug or alcohol test result. The
proposed paragraph would establish a 5-year denial of authorization
because the confirmed positive drug or alcohol test result, in
combination with such a resignation, would be a strong indication that
the individual has an active substance abuse problem. However, because
the individual resigned or withdrew his or her application for
authorization, the individual would not be available for the SAE to
evaluate the seriousness of his or her substance abuse problem and
devise an appropriate treatment plan, as required under proposed Sec.
26.189 [Determination of fitness]. Therefore, prohibiting the
individual from being granted authorization for a 5-year period would
give the individual an opportunity to seek treatment and establish a 5-
year history of sobriety, which would be required to regain
authorization under proposed Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information], while also
ensuring that such an individual is not granted authorization without
having demonstrated that he or she has overcome the substance abuse
problem.
In addition, for any type of FFD policy violation, the proposed
paragraph would require the licensee or other entity to record the fact
that the individual had resigned or withdrawn his or her application
for authorization, the nature of the FFD policy violation, and the
sanction that would have been imposed if the individual had not
resigned or withdrawn. Recording this information would be necessary to
ensure that any licensees or other entities who may consider granting
authorization to the individual in the future would be aware of the
individual's behavior and the nature of the FFD policy violation.
Subsequent licensees and other entities would then be able to ensure
that the minimum requirements of this section are met. For example, if
the FFD policy violation was a third confirmed positive drug or alcohol
test result, proposed Sec. 26.75(g) would prohibit a subsequent
licensee or other entity from granting authorization to the individual
under any circumstances.
The portion of current Sec. 26.27(c) that refers to a refusal to
provide a specimen for testing would be moved to proposed Sec.
26.75(b) for organizational clarity, as discussed with respect to that
paragraph.
Proposed Sec. 26.75(e) would amend current Sec. 26.27(b)(2) and
expand its scope to include alcohol. Abuse of alcohol would no longer
be excluded from the sanctions specified in this proposed section for
several reasons. First, although the possession and use of alcohol are
legal for adults and do not adversely reflect on an individual's
trustworthiness and reliability, a perceived need to conceal an
untreated, active alcohol abuse problem could cause an individual to be
vulnerable to influence to act in ways that are adverse to the common
defense and security. Second, alcohol-related impairment in the nuclear
workplace poses an undue potential risk to public health and safety
that is comparable to the risk imposed by impairment from the use of
drugs. Third, some licensees have not imposed appropriately stringent
sanctions on individuals who have abused alcohol in a manner that could
cause the individual to be impaired while performing the job duties
that require individuals to be subject to this part. Therefore, in
order to deter individuals from abusing alcohol and ensure that
individuals who may be impaired from alcohol are not permitted to
perform job duties under this part, the proposed rule would impose the
same sanctions for abusing alcohol as those required for abusing drugs
in the proposed paragraph. The proposed change would be made to meet
Goal 3 of this rulemaking, which is to improve the effectiveness of FFD
programs.
Proposed Sec. 26.75(e)(1) would retain the intent of the second
sentence of current Sec. 26.27(b)(2), which states that licensees and
other entities must remove an individual from performing activities
under this part for at least 14 days following a first confirmed
positive test result. However, the proposed paragraph would require
licensees and other entities to terminate the individual's
authorization for at least 14 days, rather than ``remove'' the
individual. At the public meetings discussed in Section V, the
stakeholders indicated that the term, ``remove,'' is confusing because
it could be interpreted as requiring licensees and other entities to
terminate the individual's employment, which is not the intent of this
paragraph. The stakeholders suggested using the phrase, ``terminate the
individual's authorization,'' to more accurately characterize the
required action, with which the NRC concurred.
The stakeholders also requested that the requirements in the
current paragraph related to referring the individual to the EAP for
assessment and counseling be eliminated from proposed Sec.
26.75(e)(1). The stakeholders noted that many licensees terminate an
individual's employment at the same time that they terminate the
individual's authorization after a first confirmed positive test
result. They suggested that, if the licensee or other entity terminates
the individual's employment and does not intend to provide the
individual with an opportunity to regain authorization, it is
inappropriate to require the licensee or other entity to provide
assessment and counseling services to the individual. However, some
licensees have interpreted the current provision as requiring them to
provide EAP services to individuals who are no longer in their employ.
The NRC concurs that the intent of the current rule is for licensees
and other entities to provide assessment and counseling services only
in those instances in which the licensee or other entity desires to
reinstate the individual's authorization. Therefore, the proposed
change would be made to clarify the intent of the provision.
The proposed rule would also move the requirements in the current
paragraph that are related to permitting the individual to regain
authorization from this section to proposed Subpart C [Granting and
Maintaining Authorization], because this section would address
sanctions for FFD policy violations, rather than FFD requirements for
granting authorization. Requirements for granting authorization to an
individual after his or her authorization has been terminated
unfavorably for a first confirmed positive drug or alcohol test result
would be addressed in proposed Sec. 26.69(b) [Authorization after a
first confirmed positive drug or alcohol test result or a 5-year denial
of authorization] of proposed Subpart C. This proposed change would be
made for organizational clarity in the rule.
Proposed Sec. 26.75(e)(2) would increase the length of the period
for which licensees and other entities must deny an individual's
authorization for a second confirmed positive test result from 3 years
in current Sec. 26.27(b)(vii) to 5 years. This proposed change would
be made to provide higher assurance that individuals who have had a
second confirmed positive test result are able to abstain from
substance abuse for at least 5 years before a licensee or other entity
may again consider granting authorization to them. The 5-year period is
based upon the research literature indicating that individuals who
abstain from substance abuse for 5 years after
[[Page 50517]]
treatment are less likely to relapse than individuals who have been
able to abstain for 3 years. In addition, the proposed more stringent
sanction for a second confirmed positive test result would provide
greater deterrence to recidivism than the current 3-year period.
Proposed Sec. 26.75(f) would amend current Sec. 26.27(b)(5),
which states that the sanctions for confirmed positive drug test
results in current Sec. 26.27 do not apply to the misuse of alcohol,
valid prescriptions, and over-the-counter drugs, but requires
licensees' FFD policies to establish sanctions that are sufficient to
deter misuse of those substances. The proposed rule would require the
same minimum sanctions for alcohol abuse as those required for drug
abuse. Impairment caused by alcohol abuse creates a risk to public
health and safety that is fundamentally similar to the risk posed by
the use of illegal drugs. Some licensees, however, have imposed lesser
sanctions for alcohol violations, an approach that is inconsistent with
the NRC's intent. Therefore, the proposed rule would rectify this
situation by explicitly requiring the same minimum sanctions for abuse
of alcohol as currently required for the use of illegal drugs.
In addition, proposed Sec. 26.75(f) would require licensees and
other entities to impose the same sanctions as required for abuse of
illegal drugs if the MRO determines that misuse of prescription drugs
or over-the-counter medications that results in a positive drug or
alcohol test result represents substance abuse. The MRO would make this
determination in accordance with proposed Sec. 26.185(j). Misuse of
prescription and over-the-counter medications may include, for example,
the use of a spouse's or other family member's prescription medications
that may cause impairment, such as some pain relievers, or the
excessive use of some cold and cough preparations available over-the-
counter containing alcohol or other active ingredients that may cause
impairment. However, the same substances may be used by an individual
who has a substance abuse problem. For example, an individual who has
become addicted to opiates may use a spouse's or other family member's
codeine tablets or other opiates that were prescribed for pain relief
to assist the addicted individual in avoiding withdrawal symptoms.
Under the proposed paragraph, if the MRO determines that an
individual's use of a prescription or over-the-counter medication
represents substance abuse, the licensee or other entity would be
required to impose the minimum sanctions specified in this proposed
section for a confirmed positive drug or alcohol test result, as
appropriate. If the MRO determines that the misuse of a prescription or
over-the-counter medication does not represent substance abuse, the
proposed rule would require the licensee or other entity to impose the
sanctions for substance misuse that the licensee or entity would
specify in the FFD policy.
The proposed rule would also revise but retain the requirement in
the last sentence of current Sec. 26.27(b)(5), which states that
sanctions for the misuse of prescription and over-the-counter drugs
must be sufficient to ``deter abuse of legally obtainable substances.''
These sanctions must be sufficient to deter the misuse of prescription
and over-the-counter medications because such misuse may lead to
impairment on the job. However, the proposed rule would eliminate the
phrase, ``as a substitute for abuse of proscribed drugs,'' in the last
sentence of current Sec. 26.27(b)(5) because it unnecessarily limits
the circumstances in which sanctions for the misuse of prescription and
over-the-counter drugs would be imposed.
Proposed Sec. 26.75(g) would amend current Sec. 26.27(b)(4). The
portions of the current paragraph that establish requirements for
granting authorization to an individual who has violated the licensee's
or other entity's FFD policy would be moved to proposed Sec. 26.69
[Authorization with potentially disqualifying fitness-for-duty
information] in Subpart C [Granting and Maintaining Authorization] for
organizational clarity because proposed Sec. 26.75(g) would only
address sanctions for FFD policy violations. The proposed paragraph
would retain the portion of the current paragraph that requires
licensees and other entities to permanently deny authorization to an
individual who has repeatedly violated a licensee's or other entity's
FFD policy. The proposed rule would require an individual's
authorization to be denied permanently if he or she has another
confirmed positive drug or alcohol test result after he or she has had
authorization denied for 5 years in accordance with other paragraphs in
this proposed section. This proposed more stringent sanction would
strengthen the effectiveness of the rule in providing reasonable
assurance that individuals who are subject to this part are trustworthy
and reliable, as demonstrated by avoiding substance abuse, and by
increasing the assurance that only individuals who are fit for duty are
permitted to perform the job duties listed in proposed Sec. 26.25
[Individuals subject to the fitness-for-duty program].
Proposed Sec. 26.75(h) and (i) would amend current Sec.
26.24(d)(2), which permits licensees to temporarily suspend an
individual's authorization or take other administrative action if an
individual has a positive drug test result for marijuana or cocaine
metabolites that is identified through initial testing at the licensee
testing facility. For organizational clarity, the proposed rule would
divide the current paragraph into two paragraphs to separate the
requirements related to the conditions under which licensees and other
entities may and may not take action on the basis of initial test
results.
Proposed Sec. 26.75(h) would continue to prohibit licensees and
other entities from taking administrative actions or imposing sanctions
on an individual based on an positive initial drug test result reported
by an HHS-certified laboratory. The proposed paragraph would also
continue to permit licensees and other entities to take administrative
actions on the basis of positive initial drug test results for
marijuana and cocaine from a licensee testing facility. However, in
order for the licensee or other entity to take action, the proposed
rule would require that the urine specimen that yields a non-negative
drug test result(s) must also appear to be a valid specimen, based upon
the results of validity screening or initial validity test results at
the licensee testing facility. In addition, the proposed paragraph
would prohibit licensees and other entities from imposing sanctions or
taking other actions in response to non-negative validity screening or
initial validity test results from a specimen in which no drug
metabolites were detected. This proposed prohibition would be added
because the procedures, instruments, and devices used in conducting
validity screening and initial validity tests have not yet been proven
to be sufficiently accurate and reliable to support management actions
or sanctions without confirmatory testing. Permitting licensees and
other entities to take actions on the basis of validity screening or
initial validity test results would risk imposing substantial burdens
on individuals from false non-negative test results. Therefore, this
prohibition would be added to meet Goal 7 of this rulemaking, which is
to protect the due process rights of individuals who are subject to
Part 26.
Proposed Sec. 26.75(i)(1)-(4) would retain the requirements in
current Sec. 26.24(d)(2)(i)-(iv) that establish the conditions under
which licensees and other entities may take administrative
[[Page 50518]]
actions on the basis of a positive initial drug test result for
marijuana or cocaine metabolites from a licensee testing facility. The
proposed rule would add a requirement for specimen validity testing
(see the discussion of proposed Sec. 26.31(d)(3)(i) with respect to
the addition of validity testing requirements in the proposed rule) and
require that the specimen for which action will be taken must appear to
be valid, based on validity screening or initial validity test results
from the licensee testing facility. The proposed rule would also revise
the terminology used in the current paragraph to be consistent with the
terminology used throughout the proposed rule (see the discussion of
proposed Sec. 26.5 [Definitions] with respect to the new terminology
adopted in the proposed rule) and update the cross-references to other
sections of the rule to be consistent with the organization of the
proposed rule.
Section 26.77 Management Actions Regarding Possible Impairment
A new Sec. 26.77 [Management actions regarding possible
impairment] would amend the requirements of current Sec. 26.27(b)(1).
The current paragraph requires licensees and other entities to remove
impaired workers, or those whose fitness may be questionable, from
performing activities within the scope of this part, and permits them
to return the individuals to duty only after the individuals are
determined to be fit to safely and competently perform their duties.
The proposed section would retain the intent of the current provision,
but the terminology used in the proposed section would be revised to be
consistent with the terminology used throughout the proposed rule.
Cross-references to other sections of the rule would be updated to be
consistent with the organization of the proposed rule. In addition,
several new requirements would be added.
Proposed Sec. 26.77(a) would be added to describe the purpose of
the proposed section, which is to prescribe the management actions that
licensees and other entities must take when an individual shows
indications that he or she is not fit to safely and competently perform
the duties that require the individual to be subject to this part. The
proposed paragraph would be added to introduce the section and to meet
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule.
Proposed Sec. 26.77(b) would retain the portion of current Sec.
26.27(b)(1) that requires the licensee or other entity to take
immediate action to prevent an individual from performing the job
duties that require the individual to be subject to this part if an
individual appears to be impaired, or his or her fitness is
questionable. The proposed paragraph would add cross-references to
proposed Sec. 26.27(c)(3), and Sec. 26.199(h) and (i), because the
proposed provisions would provide exceptions to the requirement for
immediate action. Proposed Sec. 26.27(c)(3) would permit licensees and
other entities to use individuals who have consumed alcohol if they are
needed to respond to an emergency and the licensee or other entity
establishes controls and conditions under which the individual may
perform work safely. Proposed Sec. 26.199(h) and (i) would also permit
licensees who are subject to proposed Subpart I [Managing Fatigue] to
use fatigued individuals to perform work if the licensee determines
that they are needed to protect the common defense and security or
respond to an emergency and establishes controls and conditions under
which the individual may perform work safely. The cross-references
would be added to meet Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule.
The proposed rule would also revise some terminology used in the
current paragraph in response to stakeholder requests during the public
meetings discussed in Section V. The stakeholders indicated that,
because the current rule requires them to ``remove'' individuals whose
fitness may be questionable, some FFD programs have interpreted the
current paragraph as requiring them to terminate the individual's
authorization. This was not the intent of the current provision. In
this instance, the intent of the rule was for licensees and other
entities to prevent the individual from performing the job duties that
would require the individual to be subject to this part in order to
ensure that any potential impairment could not result in errors or
lapses in judgment that may pose a risk to public health and safety or
the common defense and security until the cause of the problem could be
identified and resolved. Therefore, the proposed rule would replace the
phrase, ``removed from activities within the scope of this part,'' with
the phrase, ``prevent the individual from performing the job duties,''
and make other minor changes to the wording of the current requirement
to clarify the intent of the provision. The proposed changes would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the language of the rule.
Proposed Sec. 26.77(b)(1) would retain the intent of current Sec.
26.24(a)(3), which requires licensees and other entities to conduct
drug and alcohol testing for cause. The proposed rule would require
for-cause testing based upon a ``reasonable suspicion'' that the
individual may be impaired from possible substance abuse. Reasonable
suspicion of substance abuse could be based upon an observed behavior,
such as unusual lack of coordination or slurred speech, or a physical
condition, such as the smell of alcohol. If the only basis for a
reasonable suspicion is the smell of alcohol, then alcohol testing
would be required, but the proposed rule would not require the licensee
or other entity to perform a drug test unless other indicators of
possible impairment are present.
The proposed rule would not require drug testing without other
indicators of impairment in response to stakeholder comments made
during the public meetings discussed in Section V. The stakeholders
reported that many of the for-cause tests they perform are initiated as
a result of a security officer or other person reporting that an
individual smells of alcohol without behavioral indications of
impairment. They also noted that the very large majority of the for-
cause drug tests that they conduct in these circumstances yield
negative results, including those instances in which the alcohol test
results are positive. The stakeholders suggested that the current
requirement to conduct drug tests in these circumstances imposes a
significant burden because the drugs tests impose costs, not only for
collecting and testing the urine specimens, but also because they
cannot permit the individual to resume performing his or her job duties
until the drug test results are available, which may take several days.
The stakeholders argued that the burden is unnecessary because the drug
tests yield positive results so infrequently and, therefore, do not
serve their intended purpose of detecting drug abuse. Based on the
stakeholders arguments and the FFD program performance data that
support them, the NRC concurs that drug testing is unnecessary when the
smell of alcohol is the only indication that for-cause testing is
required, and so would eliminate it from the proposed rule. The
proposed rule would continue to require drug testing if there are
behavioral or physical indications of impairment in addition to the
smell of alcohol.
Proposed Sec. 26.77(b)(2) would be added but would apply only to
nuclear power plant licensees who would be subject to proposed Subpart
I [Managing Fatigue]. The proposed paragraph would permit these
licensees to forego drug and alcohol testing and a
[[Page 50519]]
determination of fitness, if the licensee is certain that the
individual's observed behavior or physical condition is solely due to
fatigue. In this case, the proposed rule would require the licensee to
conduct a fatigue assessment, as defined in proposed Sec. 26.201
[Fatigue assessments], before permitting the individual to return to
performing his or her job duties.
Proposed Sec. 26.77(b)(3) would be added to specify the actions
that licensees and other entities must take when there are indications
that an individual may be impaired, other than behavior or a physical
condition that creates a reasonable suspicion of substance abuse (or
fatigue, in the case of licensees who are subject to proposed Subpart
I). Consistent with current Sec. 26.27(b)(1), the proposed rule would
permit the licensee or other entity to return the individual to duty
only after identifying and resolving the cause of the impairing
condition, and making a determination of fitness indicating that the
individual is fit to safely and competently perform his or her duties
(see the discussion of proposed Sec. 26.189 [Determination of fitness]
for a more detailed discussion of the determination of fitness
process). The proposed paragraph would not require licensees and other
entities to unfavorably terminate an individual's authorization for
illness, fatigue, temporary mental and emotional stress, or other
conditions that may affect an individual's fitness, but would prohibit
the licensee or other entity from assigning the impaired individual to
perform job duties that require the individual to be subject to this
part until a determination is made that the individual is fit to return
to duty.
Proposed Sec. 26.77(c) would update current Sec. 26.27(d) to be
consistent with current NRC notification procedures.
Subpart E--Collecting Specimens for Testing
Section 26.81 Purpose
Proposed Sec. 26.81 [Purpose] would be added to describe the
purpose of proposed Subpart E, which would be to establish requirements
for collecting specimens for drug and alcohol testing. Adding the
proposed section at the beginning of the proposed subpart would assist
in locating provisions within the rule and so would be consistent with
Goal 6 of the rulemaking, which is to improve clarity in the
organization and language of the rule.
Section 26.83 Specimens To Be Collected
A new Sec. 26.83 [Specimens to be collected] would specify the
types of specimens that licensees and other entities must collect for
initial and confirmatory drug and alcohol testing.
Proposed Sec. 26.83(a) would require licensees and other entities
to collect either breath or oral fluids (i.e., saliva) for initial
tests for alcohol. The proposed rule would continue to require
collecting only breath specimens for confirmatory alcohol testing. The
proposed rule would add permission to use oral fluids (i.e., saliva)
for initial alcohol tests because devices for testing oral fluids for
alcohol have matured sufficiently to provide valid and reliable initial
test results. Further, there may be circumstances, such as collecting a
specimen of oral fluids from a donor who has impaired lung functioning,
in which the use of such devices is more efficient for both donors and
the FFD program than collecting breath specimens. Therefore, the
proposed permission to collect oral fluids for initial alcohol testing
would meet Goal 3 of this rulemaking, which is to improve the
efficiency of FFD programs. Additionally, other Federally mandated
alcohol testing programs permit the use of these devices for initial
alcohol testing. Therefore, adding permission to collect oral fluids
for initial alcohol testing to the proposed rule would also be
consistent with Goal 1 of the rulemaking, which is to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
The proposed rule would eliminate the use of blood as a specimen
for alcohol testing at the donor's discretion, which is permitted in
current Sec. 26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26.
The proposed rule would eliminate the current provisions related to
blood alcohol testing for several reasons. Since the current rule was
first promulgated, licensees have repeatedly raised questions related
to the proper interpretation of a confirmatory alcohol test result
using an evidential breath testing device (EBT) and an alcohol test
result derived from a blood specimen when the results from the two
types of testing differ. Specifically, if a confirmatory alcohol test
result using an EBT is positive, but the result from testing a blood
specimen is negative, licensees have asked which test result they
should rely on in determining whether the donor has violated the FFD
policy. Although the NRC's original intent was that the result from the
blood test was to be definitive, delays in obtaining a blood specimen
have sometimes resulted in blood test results that fell below the
alcohol cutoff level of 0.04 percent BAC due to alcohol metabolism
during the period of the delay. Some licensees have been reluctant to
apply sanctions for a positive alcohol test result in these instances
even though alcohol metabolism over time would explain the lower test
result from the blood sample. Further, experience has shown that few
donors request testing of a blood sample. Data gathered from a sampling
of representative FFD programs show that individuals requested an
average of fewer than one blood test per program within the period
reviewed (January-May 2002). Additionally, the use of EBTs for
confirmatory alcohol tests has consistently withstood legal challenge.
The added protection of donors' rights that was envisioned when the
provisions for voluntary testing of blood specimens were incorporated
into the current rule has not been realized in practice. The current
requirement has also been costly for licensees, who are required to
ensure that an individual who is trained to draw blood is available to
do so, should a donor request blood testing. Based upon information
provided by stakeholders at the public meetings discussed in Section V,
the NRC determined that the costs associated with retaining this
provision are not justified because of the very few instances in which
donors have requested blood alcohol testing. Therefore, references to
collecting and testing blood specimens for alcohol would be deleted
from the proposed rule.
Proposed Sec. 26.83(b) would retain but make explicit the implied
requirement in the first sentence of current Sec. 26.24(b) (and other
provisions that are interspersed throughout the current rule) for
licensees and other entities to collect only urine specimens for drug
testing. At the time the current rule was promulgated, it was
unnecessary to establish an explicit requirement to collect and test
only urine specimens for drugs in Part 26 programs because methods for
testing other specimens were not available and the HHS Guidelines only
addressed testing urine specimens. Since that time, methods for testing
alternate specimens, such as oral fluids, sweat, and hair, have become
commercially available and the HHS has published proposed revisions to
its Guidelines (69 FR 19673; April 13, 2004) that would permit the use
of such alternate specimens for drug testing in Federal workplace drug
testing programs. The NRC is considering
[[Page 50520]]
permitting the use of alternate specimens for drug testing when the HHS
has published final revisions to its Guidelines related to these types
of specimens. The revised HHS Guidelines will identify acceptable
collection procedures and testing methods. However, HHS has not yet
published final Guidelines for collecting and testing these alternate
specimens. Therefore, it is necessary to add Sec. 26.83(b) to the
proposed rule to clarify that the NRC intends to continue prohibiting
the collection and drug testing of specimens other than urine in this
rulemaking, except as permitted under proposed Sec. 26.31(d)(5)
[Medical conditions] for the reasons discussed with respect to that
paragraph.
Section 26.85 Collector Qualifications and Responsibilities
A new Sec. 26.85 [Collector qualifications and responsibilities]
would replace the collector qualifications and training requirements
that are specified in the definition of ``collection site person'' in
current Sections 1.2, 2.2(d), and 2.4(b) in Appendix A to Part 26. The
intent of the current provisions would be retained in the proposed
section, but the proposed rule would group the requirements together
within this section for organizational clarity in the rule. In
addition, as will be described below, the proposed rule would amend the
current collector qualifications and training requirements to increase
the consistency of Part 26 with the requirements of other Federal
agencies and incorporate the lessons learned from those programs, as
discussed in Section IV. B with respect to Goal 1 of this rulemaking.
Proposed Sec. 26.85(a) [Urine collector qualifications] would be
added to provide more detailed requirements for urine collector
qualifications and training than are contained in the current
definition of ``collection site person'' and current Section 2.2(d) in
Appendix A to Part 26. The proposed paragraph would require urine
collectors to be knowledgeable of the requirements of this part, the
FFD policy and procedures of the licensees or other entities for whom
collections are performed, and keep current on any changes to urine
collection procedures. The proposed changes would increase the
consistency of urine collector qualification requirements with those of
other Federal workplace drug testing programs as well as consistency
between Part 26 urine collection procedures. These more detailed
requirements would be added for the reasons discussed in Section IV.C.
Proposed Sec. 26.85(a) would retain the requirements in current
Section 2.2(d) that urine collectors must receive training to perform
their duties and demonstrate proficiency in applying the requirements
of the proposed paragraph before serving as a collector. Proposed Sec.
26.85(a)(1)-(a)(3) would list the topics that the proposed rule would
require collector training to address. Proposed Sec. 26.85(a)(1) would
require collectors to be trained in the steps that are necessary to
complete a collection correctly and the proper completion and
transmission of the custody-and-control form to the licensee testing
facility or HHS-certified laboratory, as appropriate. Proposed Sec.
26.85(a)(2) would require training in methods to address ``problem''
collections, which may include, but would not be limited to,
collections involving ``shy bladder'' (see the discussion of proposed
Sec. 26.119 [Determining ``shy'' bladder] for an explanation of this
term and the procedures involved) and attempts by a donor to tamper
with a specimen. Proposed Sec. 26.85(a)(3) would require the training
to instruct collectors on how to correct problems in collections, which
may include, but would not be limited to, a donor refusing to cooperate
with the collection process or an incident in which a urine specimen is
spilled. These proposed requirements would be added to meet Goal 1 of
this rulemaking, which is to update and enhance the consistency of Part
26 with advances in other relevant Federal rules and guidelines.
Proposed Sec. 26.85(a)(4) would retain the portion of current
Section 2.2(d)(1) in Appendix A to Part 26 that requires collector
training to emphasize the collector's responsibility for maintaining
the integrity of the specimen collection and transfer process, to
carefully ensure the modesty and privacy of the donor, and avoid any
conduct or remarks that might be construed as accusatorial or otherwise
offensive or inappropriate.
Proposed Sec. 26.85(b) [Alcohol collector qualifications] would be
added to specify requirements related to alcohol collector
qualifications and training. Portions of this paragraph would be the
same as the requirements for urine collectors in proposed Sec.
26.85(a), including the first three sentences of proposed Sec.
26.85(b) and proposed Sec. 26.85(b)(4) and (b)(5), and would be added
here for the same reasons discussed above with respect to the first
three sentences of proposed Sec. 26.85(a), and proposed Sec.
26.85(a)(3) and (a)(4), respectively. The proposed rule would repeat
the requirements that are applicable to both urine and alcohol
collectors in each of these paragraphs because some FFD programs may
not train collectors to perform both types of collections. Repeating
the requirements would make it easier to locate the requirements that
apply to urine or alcohol collectors, respectively, to meet Goal 6 of
the rulemaking, which is to improve clarity in the organization of the
rule.
Proposed Sec. 26.85(b)(1) and (b)(3) would require alcohol
collectors to receive training that addresses the alcohol testing
requirements of this part and methods to address ``problem''
collections, including, but not limited to, collections involving ``shy
lung'' problems or attempts by a donor to tamper with a specimen. By
contrast to proposed Sec. 26.85(a)(2), which addresses ``shy bladder''
problems in urine collections, the proposed rule would not incorporate
the related DOT procedures for determining ``shy lung'' problems in
alcohol collections. During the public meetings discussed in Section V,
stakeholders requested that the proposed rule incorporate DOT's ``shy
bladder'' procedures, but did not believe that adding DOT's ``shy
lung'' procedures to the proposed rule is necessary. The stakeholders
reported that ``shy lung'' has not been a problem for donors, based on
their experience implementing the breath testing requirements of Part
26 since the rule was first promulgated. Therefore, proposed paragraph
Sec. 26.85(b)(3) would require alcohol collectors to be able to
implement the ``shy lung'' procedures established by any FFD program
for whom the collectors are providing collection services, but would
not establish requirements for responding to ``shy lung'' problems in
the rule. The NRC invites comment on this omission.
Proposed Sec. 26.85(b)(2) would be added to require alcohol
collectors to be trained in the operation of the particular alcohol
testing device(s) [i.e., the alcohol screening devices (ASDs) and
evidential breath testing devices (EBTs)] to be used in conducting
alcohol tests, consistent with the most recent version of the
manufacturers' instructions. The proposed rule would add a requirement
for alcohol collectors to be trained to follow the most recent version
of the testing device manufacturers' instructions because the NRC is
aware that some FFD programs did not implement device manufacturers'
recommended changes to instructions for using the testing devices.
Although the NRC staff is not aware of any testing errors or instances
in which donors have challenged the results of alcohol tests that were
not performed in accordance with the most recent version
[[Page 50521]]
of the device manufacturer's instructions, the proposed rule would add
this requirement to ensure that alcohol test results continue to be
accurate and cannot be challenged on this basis. The proposed changes
would also be consistent with the alcohol collector training
requirements of other Federal agencies.
Proposed Sec. 26.85(c) [Alternative collectors] would amend the
last sentence of current Section 2.2(d)(2) in Appendix A to Part 26,
which permits medical personnel to perform specimen collections without
receiving the training that is required for non-medical collectors. The
proposed rule would permit medical personnel to conduct specimen
collections for the purposes of this part only under the conditions
that would be specified in proposed Sec. 26.85(c)(1)-(c)(5), which may
include, but would not be limited to the collection of specimens for
post-event testing by a nurse or medical technician at a hospital. The
proposed rule would limit the circumstances in which an untrained
medical professional, technologist, or technician may perform
collections for a licensee or other entity because the experience of
other Federal agencies has shown that medical personnel who are
untrained in specific collection procedures have committed errors in
collections that resulted in unnecessary legal challenges to test
results. At the same time, the NRC is also aware that licensees and
other entities may occasionally have to rely upon such individuals to
collect specimens for drug and alcohol testing, as discussed with
respect to proposed Sec. 26.25(b)(1). Therefore, the proposed rule
would permit untrained medical personnel to collect specimens to
facilitate the collection of specimens for testing in rare
circumstances in which a qualified collector could not reasonably be
expected to be available, but would otherwise require medical personnel
who do not meet the criteria specified in proposed Sec. 26.85(c)(1)-
(c)(5) to receive the same training as non-medical collectors. The
proposed change would be made to meet Goal 3 of the rulemaking, which
is to improve the effectiveness and efficiency of FFD programs, by
reducing the likelihood of errors and legal challenges to test results.
The proposed rule would eliminate current Section 2.2(d)(4) in
Appendix A to Part 26, which requires that donors must be informed of
the option to request blood testing. The current requirement would be
eliminated because blood specimens would no longer be used for alcohol
testing, as discussed with respect to current Sec. 26.83(a).
Proposed Sec. 26.85(d) would amend current Section 2.7(o)(5)
[Personnel available to testify at proceedings] in Appendix A to Part
26, which requires that the licensee testing facility and HHS-certified
laboratory must make available qualified individuals to testify in
administrative or disciplinary proceedings related to drug and alcohol
test results. The proposed rule would add an explicit requirement for
collection site personnel to be available to testify at proceedings
because this requirement is implied but not explicitly stated in the
current provision. At the time the rule was first published, licensee
testing facilities and collection sites were typically co-located at a
site. However, this is no longer the case. In some current FFD
programs, alcohol testing and urine specimen collections occur at the
collection site, but initial testing of urine specimens is performed at
a licensee testing facility, which may not be co-located with the
collection site. Therefore, the proposed rule would add this paragraph
to retain the NRC's original intent that licensees and other entities
must make available collection site personnel to testify, as needed, in
administrative and/or legal proceedings related to an alcohol or drug
test result. For organizational clarity, the requirements in the
current paragraph that address the availability of personnel to testify
in proceedings related to drug test results from the licensee testing
facility would be moved to Sec. 26.139(c) of proposed Subpart F
[Licensee Testing Facilities] and those related to HHS-certified
laboratories would be moved to Sec. 26.153(f)(2) of proposed Subpart G
[Laboratories Certified by the Department of Health and Human
Services].
Section 26.87 Collection Sites
A new Sec. 26.87 [Collection sites] would be added to reorganize
current requirements related to specimen collection sites. In general,
the proposed rule would group together in this section the requirements
that are related to collection sites, which are currently distributed
among several different sections in Appendix A to Part 26. The proposed
change would be made to meet Goal 6 of this rulemaking, which is to
improve organizational clarity in the rule.
Proposed Sec. 26.87(a) would amend current Section 2.4(a) in
Appendix A to Part 26, which requires FFD programs to designate
collection sites and ensure that they are fully equipped to collect
specimens for testing. The proposed paragraph would delete reference to
blood specimens because the proposed rule would no longer provide
donors with the option to request blood testing for alcohol for the
reasons discussed with respect to proposed Sec. 26.83(a). The proposed
paragraph would add a requirement for collection sites to be capable of
alcohol testing, which was implied in the current paragraph but not
explicitly stated. This proposed change would be made to meet Goal 6 of
this rulemaking, which is to improve clarity in the language of the
rule. The proposed paragraph would retain the current permission for
licensees and other entities to use properly equipped mobile collection
facilities.
Proposed Sec. 26.87(b) would revise the first sentence of current
Section 2.4(f) in Appendix A to Part 26 to require visual privacy for
donors while the donor and collector are viewing the results of an
alcohol test and retain the current requirement for individual privacy
during urine specimen collections, except if the urine specimen
collection must be conducted under direct observation. The new
requirement for visual privacy while viewing alcohol test results would
increase the consistency of Part 26 with the alcohol testing procedures
of other Federal agencies and assure greater privacy for donors who are
subject to FFD programs who do not provide visual privacy under the
current rule. This proposed change would be made to meet Goal 7 of this
rulemaking, which is to protect the privacy of individuals who are
subject to Part 26. For organizational clarity, the proposed rule would
move the current requirements in Section 2.4(f) in Appendix A to Part
26 that are related to collecting a specimen under direction
observation to proposed Sec. 26.115 [Collecting a urine specimen under
direct observation].
Proposed Sec. 26.87(c) would retain only the portion of current
Section 2.7(m) in Appendix A to Part 26 that requires licensees' and
other entities' contracts for collection site services to permit
unfettered NRC, licensee, and other entity access to collection sites
for unannounced inspections. For organizational clarity, the
requirements in the current paragraph related to licensee testing
facilities would be relocated to proposed Subpart K [Inspections,
Violations, and Penalties] and subsumed under proposed Sec. 26.221(a).
The portions of the current paragraph that apply to HHS-certified
laboratories would be moved to Sec. 26.153(f) of proposed Subpart G
[Laboratories Certified by the Department of Health and Human
Services], also for organizational clarity.
[[Page 50522]]
In addition, proposed Sec. 26.87(c) would add a requirement that
licensees' and other entities' contracts for collection site services
must permit unfettered NRC, licensee, and other entity access to all
information and documentation that is reasonably relevant to
inspections and audits. This proposed requirement for access to
documentation would be added for consistency with the HHS Guidelines,
which also require collection sites to provide information and
documentation as part of inspections and audits. Therefore, this
proposed change would meet Goal 1 of this rulemaking, which is to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines. The term, ``audit,'' would be
added to the proposed paragraph because, although the NRC conducts
inspections, licensees and other entities would be required to conduct
audits under proposed Sec. 26.41 [Audits and corrective action].
Adding this term to the proposed paragraph would increase the clarity
of its language, consistent with Goal 6 of the rulemaking.
Proposed Sec. 26.87(d) would revise current Section 2.4(c) in
Appendix A to Part 26 to clarify current requirements for assuring
collection site security and the integrity of specimen collection
procedures. The proposed rule would group requirements related to
assuring the security of a licensee's or other entity's designated
collection site in this proposed paragraph for organizational clarity.
The requirements contained in current Section 2.4(c) in Appendix A to
Part 26 that address assuring collection security when a designated
collection site is inaccessible and there is an immediate requirement
to collect a urine specimen would be moved to proposed Sec. 26.87(f),
also for organizational clarity. The proposed paragraph would include
other clarifying changes to current Section 2.4(c) in Appendix A to
Part 26, in response to stakeholder requests for such clarifications at
the public meetings discussed in Section V, as follows:
Proposed Sec. 26.87(d)(1) would retain the first sentence of
current Section 2.4(e) in Appendix A to Part 26, which requires that
only authorized personnel may have access to any part of a collection
site in which specimens are collected and stored. This requirement
would be moved to the proposed paragraph because it addresses the topic
of collection site security. Therefore, this change would be made for
organizational clarity.
Proposed Sec. 26.87(d)(2) would amend the second sentence of
current Section 2.4(c) in Appendix A to Part 26, which requires
collection sites to be secure, by providing examples of acceptable
methods to assure collection site security. The proposed rule would add
these examples in response to stakeholder requests during the public
meetings discussed in Section V. The stakeholders noted that the
requirement that collection sites ``must be secure'' has raised many
implementation questions. Therefore, the proposed rule would add
examples of acceptable means to ensure collection site security,
including, but not limited to, physical measures to control access,
such as locked doors, alarms, or visual monitoring of the collection
site when it is not occupied. The proposed change would be made to meet
Goal 6 of this rulemaking, which is to improve clarity in the language
of the rule.
Proposed Sec. 26.87(d)(3) would amend the third sentence in
current Section 2.4(c) in Appendix A to Part 26, which requires that
the portion of any facility that is not dedicated solely to drug and
alcohol testing must be secured during testing, and combine it with the
third sentence of current Section 2.4(c)(1) in Appendix A to Part 26,
which requires posting the facility against unauthorized access during
the collection. The proposed rule would replace the phrase, ``in the
case of a public restroom,'' in the last sentence of current Section
2.4(c)(1) in Appendix A to Part 26, with the phrase, ``if a collection
site cannot be dedicated solely to collecting specimens,'' to clarify
that a specimen may be collected at locations other than public
restrooms. The proposed changes would be made to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.87(e) would be added to specify the steps that
licensees and other entities must take to deter dilution and
adulteration of specimens during urine collections. The proposed
paragraph would retain and amend portions of current Section 2.4(g) in
Appendix A to Part 26, as explained below:
Proposed Sec. 26.87(e)(1) would relax the requirement for use of a
bluing agent in any source of standing water, such as a toilet bowl or
tank, in current Section 2.4(g)(1) of Appendix A to Part 26. The
proposed rule would permit licensees and other entities to use colors
other than blue. A yellow coloring agent would not be permitted because
it would preclude the collector's ability to determine whether a donor
had diluted the specimen with water from a source of standing water in
the stall or room in which the donor provides a specimen. The proposed
relaxation would not affect the accuracy of drug tests, but would give
FFD programs increased flexibility in the choice of coloring agents.
The proposed rule would make this change in response to stakeholder
requests during the public meetings discussed in Section V and to meet
Goal 5 of this rulemaking, which is to improve Part 26 by eliminating
or modifying unnecessary requirements.
Proposed Sec. 26.87(e)(1) would also add a requirement that the
coloring agents that are added to any source of standing water in the
stall or room in which the donor is to provide a specimen cannot
interfere with drug or validity tests. The proposed requirement would
be necessary to ensure that, if a donor attempted to subvert the
testing process through diluting his or her specimen, the coloring
agent would not interfere with testing assays and, therefore, would
permit the detection of prohibited drug use. The proposed requirement
would meet Goal 3 of this rulemaking, which is to improve the
effectiveness of FFD programs, by deterring dilution attempts using
sources of standing water and increasing the likelihood that dilution
attempts of this type would be detected.
Proposed Sec. 26.87(e)(2) would retain the second sentence of
current Section 2.4(g)(1) in Appendix A to Part 26, which requires
sources of standing water to be secured, but shorten it without
changing the intended meaning of the requirement. The proposed change
would be made to improve clarity in the language of the rule.
Proposed Sec. 26.87(e)(3) would be added to require that chemicals
or products that could be used to adulterate a urine specimen must be
secured or removed from the collection site. The collector would also
be required to inspect the enclosure to ensure that no potential
adulterants are available before the donor would enter the stall or
enclosure. These requirements would be added to prevent possible donor
attempts to subvert the testing process by adulterating a urine
specimen with materials that are available at the collection site. The
proposed rule would add this provision to meet Goal 3 of this
rulemaking, which is to improve the effectiveness of FFD programs. The
proposed provision would also be consistent with the related
requirements of other Federal agencies.
Proposed Sec. 26.87(f) would reorganize current Section 2.4(c)(1),
portions of Section 2.4(c)(2), and Section 2.4(g)(10) in Appendix A to
Part 26 to prescribe acceptable procedures for collecting specimens at
locations other than a
[[Page 50523]]
designated collection site in unusual circumstances, such as a specimen
collection for post-event testing at a hospital. The proposed rule
would group these requirements together in a single paragraph and
separate them from those related to collecting specimens at a
designated collection site in proposed Sec. 26.87(d) and (e) to make
it easier to locate these requirements within the rule. The proposed
change would be made to improve organizational clarity in the rule.
Proposed Sec. 26.87(f)(1) would amend current Section 2.4(c)(1) in
Appendix A to Part 26, which establishes requirements for securing a
location that is not a designated collection site but will be used for
a specimen collection(s). The proposed rule would require either an
individual to guard access to a public rest room while the collection
is occurring, or the posting of a sign to ensure that no unauthorized
personnel enter the area during the collection. The current rule
requires only the posting of a sign, but stationing an individual to
guard access would be at least as effective. The proposed rule would
permit an individual to guard access to the collection area in response
to stakeholder requests for this flexibility during the public meetings
discussed in Section V. The proposed change would be made to meet Goal
5 of this rulemaking, which is to improve Part 26 by eliminating or
modifying unnecessary requirements.
Proposed Sec. 26.87(f)(2) would retain the third sentence of
current Section 2.4(g)(10) in Appendix A to Part 26 that requires a
water-coloring agent to be used, if possible, to deter a possible
dilution or adulteration attempt when a collection must occur at a
location other than the licensee's or other entity's designated
collection site.
Proposed Sec. 26.87(f)(3) would amend the second sentence of
current Section 2.4(g)(10), which requires that the collector must be
the same gender as the donor. If a collector of the same gender is
unavailable, the proposed paragraph would permit another person of the
same gender who is instructed in the requirements of proposed Subpart E
[Collecting specimens for testing] to assist in the collection. The
proposed paragraph would require either the collector or the observer
to remain outside the area in which the donor will provide the urine
specimen to protect the donor's privacy and the integrity of the
collection process. The proposed rule would require the observer's
identity to be documented on the custody-and-control form so that the
observer may be located should any subsequent questions arise with
respect to the collection in a review under proposed Sec. 26.39
[Review process for fitness-for-duty policy violations] or legal
proceedings. The flexibility to rely on a person of the same gender as
an observer, if a collector of the same gender is unavailable, would be
consistent with the procedures of other Federal agencies and reduce
potential embarrassment to the donor. Therefore, this proposed change
would meet Goal 1 of this rulemaking, which is to update and enhance
the consistency of Part 26 with advances in other relevant Federal
rules and guidelines, and Goal 7, which is to protect the privacy of
individuals who are subject to Part 26.
Proposed Sec. 26.87(f)(4) would require the collector, once he or
she is in possession of the donor's specimen, to inspect the area in
which the specimen donation occurred for any evidence of a subversion
attempt by the donor. The proposed paragraph would amend the fifth and
sixth sentences of current Section 2.4(g)(10) in Appendix A to Part 26
that describe the required sequence of actions during a specimen
collection and specify that a donor is permitted to flush the toilet
after a specimen donation. The proposed rule would eliminate the option
for the donor to flush the toilet and would direct the collector to
instruct the donor not to flush the toilet. The proposed change would
reduce the possibility that a donor could dispose of evidence of a
subversion attempt by flushing it down the toilet. Proposed Sec.
26.87(f)(4) would direct the collector to inspect the toilet bowl and
area once he or she receives the specimen from the donor. The proposed
rule would add these provisions to reduce the opportunities for a donor
to subvert the testing process and to meet Goal 3 of this rulemaking,
which is to improve the effectiveness of FFD programs. The proposed
requirement would also meet Goal 1 of this rulemaking, which is to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Proposed Sec. 26.87(f)(5) would amend the portions of current
Section 2.4(c)(2) in Appendix A to Part 26 that define requirements for
maintaining control of specimens that are not collected at a designated
collection site. An ``authorized individual,'' including, for example,
a security officer or hospital medical technician, would be permitted
to maintain physical custody and control of specimens in the proposed
paragraph, rather than only the collector, as is required in the
current rule. The ``authorized individual'' would be designated by the
licensee or other entity and instructed in his or her responsibilities
for maintaining custody and control of the specimen. The authorized
individual's custody of the specimen would be documented on the
custody-and-control form to ensure that the individual may be located
should any subsequent questions arise with respect to the collection in
a review under proposed Sec. 26.39 [Review process for fitness-for-
duty policy violations] or legal proceedings. The proposed change would
continue to ensure specimen integrity and security, but would respond
to industry experience, as described by stakeholders at the public
meetings discussed in Section V. The stakeholders reported that it is
sometimes difficult in unusual circumstances, such as the hospital
setting, for the collector to maintain physical custody of the specimen
until it is prepared for transfer, storage, or shipping. Therefore, the
proposed change would be made to meet Goal 5 of this rulemaking, which
is to improve Part 26 by eliminating or modifying unnecessary
requirements, while continuing to protect the privacy and due process
rights of individuals who are subject to Part 26.
Section 26.89 Preparing to Collect Specimens for Testing
A new Sec. 26.89 [Preparing to collect specimens for testing]
would describe the preliminary steps to be taken by the collector and
donor before specimens are collected for drug and alcohol testing. The
proposed section would reorganize and amend portions of the current
Appendix A to Part 26, and add several new requirements, as explained
below. The proposed rule would present these requirements in a new
section to facilitate locating them within the proposed rule to meet
Goal 6 of this rulemaking, which is to improve clarity in the
organization of the rule.
Proposed Sec. 26.89(a) would provide more detailed requirements
than those contained in current Section 2.4(g)(3) in Appendix A to Part
26 for actions to be taken if an individual does not appear for
testing. The current rule requires the collector to contact an
``appropriate authority'' to determine the actions to take if a donor
does not appear for testing. At the public meetings discussed in
Section V, some stakeholders indicated that the lack of specificity in
the current rule with respect to the actions that the ``appropriate
authority'' must take in these circumstances has led some FFD programs
to interpret this provision as requiring the imposition of the
sanctions for a ``refusal to test'' on an individual who fails to
appear, including situations in which there is
[[Page 50524]]
clear evidence that the individual had not been informed that he or she
was required to appear for testing or was otherwise not at fault for
the failure. This is not the intent of the current provision.
Therefore, under the proposed paragraph, when informed that an
individual who was selected for testing has not appeared at the
required time, FFD program management would be required to ensure that
the circumstances are investigated and determine whether the
individual's absence or tardiness represents an attempt to avoid
testing and, therefore, subvert the testing process. The proposed rule
would require the licensee or other entity to impose the sanctions
specified in proposed Sec. 26.75(b) for a refusal to test only if the
investigation identifies evidence that the individual's failure to
appear for testing was a subversion attempt. If evidence of a
subversion attempt is not identified, the proposed rule would prohibit
the licensee or other entity from imposing sanctions and require the
individual to be tested at the earliest reasonable and practical
opportunity after the individual is located. These more detailed
requirements would be added to strengthen the rule's effectiveness in
preventing subversion by ensuring that a failure to appear for testing
is investigated, which would increase the likelihood of detecting a
willful attempt to avoid testing. In addition, the proposed
requirements would prevent an individual from being subject to a
permanent denial of authorization, as would be required under proposed
Sec. 26.75(b), if the individual's failure to appear is determined to
be outside of the individual's control or otherwise not a result of a
willful attempt to avoid testing. These proposed changes would be made
to meet Goal 3 of this rulemaking, which is to improve the
effectiveness of FFD programs, and Goal 7, which is to protect the due
process rights of individuals who are subject to Part 26.
Proposed Sec. 26.89(b) would reorganize and expand current Section
2.4(g)(2) in Appendix A to Part 26, which requires the collector to
ensure that an individual who arrives at the collection site for
testing is positively identified. The proposed rule would add more
detailed requirements for the reasons discussed with respect to each
requirement in the proposed paragraph.
Proposed Sec. 26.89(b)(1) would specify the types of photo
identification that the licensee or other entity may accept to identify
the donor. Identification of the donor by the employer's representative
would no longer be permitted. The NRC is not aware of any incidents in
which an employer's representative has inaccurately identified an
individual who appeared for testing without acceptable identification.
However, permitting collectors to rely on identification by an
employer's representative provides an opportunity for individuals to
conspire to subvert the testing process by substituting the designated
donor, who may have engaged in substance abuse, with another individual
who has not abused illegal drugs or alcohol. Such a conspiracy could
prevent an individual's substance abuse from being detected through
testing. Therefore, this proposed revision would be made to provide
greater assurance that the individual who appears for testing is the
designated donor and, thereby, strengthen the effectiveness of FFD
programs in detecting substance abuse. The proposed change would also
increase the consistency of Part 26 with access authorization
requirements established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003, which is Goal 4 of
this rulemaking.
Proposed Sec. 26.89(b)(2) would amend the portion of current
Section 2.4(g)(2) in Appendix A to Part 26 that directs the collector
to stop the collection if the individual cannot be positively
identified. By contrast, the proposed paragraph would direct the
collector to proceed with the collection and inform FFD program
management that the donor did not present acceptable photo
identification. The proposed paragraph would require FFD management to
take the necessary steps to determine whether the lack of
identification is an attempt to subvert the testing process. However,
the proposed paragraph would retain the current requirement for the
collector to delay the collection until the individual can be
identified if it a pre-access test. The proposed changes would be made
for several reasons:
First, lessons learned from implementing the current rule have
indicated that the large majority of failures to present acceptable
identification are the result of miscommunication or other errors that
are easily resolved. However, stopping or delaying the specimen
collection may alter test results (e.g., if an individual has consumed
alcohol, the individual's alcohol test result would show a lower BAC
after a delay or may not be detected if testing is not conducted).
Therefore, collecting the specimens first and then resolving the
individual's identity would assure that test results would be available
and accurate from donors who are currently authorized and whose
identity has previously been confirmed by the licensee or other entity.
Therefore, this proposed change would meet Goal 3 of this rulemaking,
which is to improve the effectiveness and efficiency of FFD programs.
Second, the current requirement to stop the collection without
investigating the reasons that the individual is unable to present
acceptable identification does not ensure that an attempt by an
individual to subvert the testing process is detected. For example, an
individual who has engaged in substance abuse could delay specimen
collection by claiming to have ``forgotten'' his or her photo
identification in his or her car or locker. Permitting the individual
to leave the collection site to obtain his or her identification would
provide an opportunity for the individual to obtain an adulterant or
substitute urine that he or she could then use to subvert the testing
process. Steps that FFD program management could take to investigate
the reasons that the individual did not present acceptable
identification in this instance could include assigning a security
officer to accompany the individual to his or her car or locker to
verify the individual's claim, as well as to ensure that the individual
does not have the opportunity to bring an adulterant or substitute
urine back to the collection site. Therefore, the proposed requirement
would strengthen the effectiveness of FFD programs in detecting
attempts to subvert the testing process.
The requirement to delay the collection until the individual
presents acceptable identification if it is a pre-access test would be
retained from the current rule at the request of stakeholders during
the public meetings discussed in Section V. The stakeholders noted that
the current requirement to delay pre-access testing until the
individual presents acceptable photo identification does not present a
risk to public health and safety or the common defense and security
from a possible subversion attempt because the individual would not yet
have access to sensitive information, radiological materials, or safety
systems and equipment. Further, stakeholders noted that retaining the
current provision would save them the expense associated with
collecting and testing a specimen that may be collected from the wrong
individual. The NRC concurs that it is reasonable to retain the current
requirement as it relates to pre-access tests for the reasons given by
the stakeholders.
[[Page 50525]]
Proposed Sec. 26.89(b)(3) would update current Sections 2.4(g)(4)
and 2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any
specimens are collected, donors are required to list the prescription
and over-the-counter medications they have used within the 30 days
before testing. To be consistent with the privacy requirements of the
Americans with Disabilities Act [Pub. L. 101-336, July 26, 1990], the
proposed rule would eliminate the requirement to list medications prior
to specimen collection and testing. The proposed rule would require
donors to provide medication information to the MRO only in the event
of non-negative confirmatory validity or drug test results in order to
enhance their rights to privacy under the rule. This revised
requirement would also be consistent with the procedures of other
Federal agencies and would meet Goal 1 of this rulemaking, which is to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Proposed Sec. 26.89(b)(3) would also add a requirement for the
collector to explain the testing procedure to the donor. Current
Section 2.2(d)(3) in Appendix A to Part 26 requires that individuals
who are subject to testing must be provided with standard written
instructions setting forth their responsibilities. However, the NRC is
aware that these instructions are typically provided to individuals as
part of the training that is required under current Sec. 26.21 [Policy
communications and awareness training] rather than at the collection
site before starting the specimen collection process, which was not the
intent of Section 2.2(d)(3) in Appendix A to Part 26. Rather than
retaining and clarifying the current provision for standard written
instructions, which some individuals have may difficulty comprehending,
the proposed rule would adopt the related practices of other Federal
agencies, which require the collector to explain the testing procedure
to the donor. This proposed change would ensure that individuals are
informed of the testing process in which they must participate and
their responsibilities within it to meet Goal 7 of this rulemaking,
which is to protect the due process rights of individuals who are
subject to Part 26. In addition, the proposed revision would enhance
the consistency of Part 26 with the requirements of other Federal
agencies.
Proposed Sec. 26.89(c) would be added to ensure that the donor is
aware of his or her responsibilities to cooperate with the specimen
collection process. The proposed paragraph would respond to reports
from stakeholders at the public meetings discussed in Section V that
some donors have attempted to obstruct or delay the collection process
on the basis that the donor's responsibility to cooperate with the
collection process is implied, but not clearly specified, in the
current rule. Therefore, the proposed paragraph would eliminate that
basis for obstructing or delaying collections, which would improve the
effectiveness and efficiency of FFD programs, consistent with Goal 3 of
this rulemaking.
The proposed paragraph would also require the collector to inform
the donor that a failure to cooperate in the specimen collection
process would be considered a refusal to test and may result in the
permanent denial of authorization under proposed Sec. 26.75(b).
Informing donors of the potential consequences of failing to cooperate
in the collection process, in advance, would be consistent with Goal 7
of this rulemaking, which is to protect the due process rights of
individuals who are subject to Part 26. The requirements of this
proposed paragraph would also be consistent with the practices of other
Federal agencies.
Proposed Sec. 26.89(d) would retain the last two sentences of
current Section 2.4(e) in Appendix A to Part 26. These sentences
require the collector to conduct only one urine specimen collection at
a time and define the point at which the collection process ends, which
is when the donor has left the collection site. The proposed paragraph
would be retained in this section because it relates to the topic of
the proposed section, which is preparing for specimen collections, to
ensure that collectors are aware of this requirement before they begin
collecting any specimens. The proposed change would improve the
organizational clarity of the rule.
Section 26.91 Acceptable Devices for Conducting Initial and
Confirmatory Tests for Alcohol and Methods of Use
A new Sec. 26.91 [Acceptable devices for conducting initial and
confirmatory tests for alcohol and methods of use] would amend current
requirements for alcohol testing devices and methods of use. The
requirements in the current rule that are related to this topic appear
in current Sec. 26.24(g) and Sections 2.4(g)(18) and 2.7(o)(3)(ii) in
Appendix A to Part 26. The proposed section would combine these
requirements into one section, amend the current requirements, and add
others, as explained below. The proposed rule would group these
requirements in one section to meet Goal 6 of this rulemaking, which is
to improve clarity in the organization of the rule.
Proposed Sec. 26.91(a) [Acceptable alcohol screening devices]
would be added to permit the use of alcohol screening devices (ASDs)
for initial testing and establish requirements for the ASDs that may be
used. Acceptable ASDs would include alcohol saliva analysis devices and
breath testing devices that are listed on the most recent version of
NHTSA's Conforming Products List (CPL) for ASDs (May 4, 2001, 66 FR
22639, and subsequent amendments thereto). Current Section
2.7(o)(3)(ii) in Appendix A to Part 26 limits FFD programs to using
only evidential-grade breath testing devices. However, permitting FFD
programs to use ASDs listed on NHTSA's CPL for initial alcohol testing
would be consistent with other Federal agencies' procedures for
workplace alcohol testing. Therefore, the proposed change would meet
Goal 1 of this rulemaking, which is to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
Further, permitting the use of some ASDs for initial alcohol
testing would provide increased flexibility in conducting initial
alcohol tests. Licensees and other entities may find that, over time,
it is less expensive to use a particular ASD than to continue using
EBTs for all initial alcohol tests. The option to use alcohol saliva
analysis devices also may reduce the burden of alcohol testing for some
donors, such as individuals who have impaired lung functioning. The
proposed rule's permission to use ASDs that are listed on NHTSA's CPL
for ASDs for initial alcohol testing would meet Goal 5 of this
rulemaking, which is to improve Part 26 by eliminating or modifying
unnecessary requirements, by increasing FFD programs' flexibility in
administering initial alcohol tests.
A new Sec. 26.91(b) [Acceptable evidential breath testing devices]
would amend current Section 2.7(o)(3)(ii) in Appendix A to Part 26 and
establish new requirements for the EBTs that licensees and other
entities must use for confirmatory alcohol breath testing. The proposed
paragraph would require licensees and other entities to use EBTs that
are listed on the most recent version of NHTSA's CPL for evidential
breath testing devices (October 3, 2002, 67 FR 62091, and subsequent
amendments thereto) when conducting confirmatory alcohol tests, and
permit licensees and other entities to use these EBTs for conducting
initial alcohol tests. These EBTs incorporate many improvements in EBT
technology and
[[Page 50526]]
have been shown to accurately detect BACs at the 0.02 percent level.
Therefore, they are the appropriate instruments to use for testing at
the revised alcohol cutoff levels specified in proposed Sec. 26.103
[Determining a confirmed positive test result for alcohol].
Further, because these EBTs have been shown to provide valid,
reliable, and legally defensible results in other Federal programs that
also require workplace alcohol testing, the proposed requirement to use
these EBTs would permit two additional proposed changes to the alcohol
testing procedures contained in current Section 2.4(g)(18) in Appendix
A to Part 26: (1) Collecting only one breath specimen for the initial
alcohol test and one for the confirmatory test in proposed Sec. Sec.
26.95(c) and 26.101(c), rather than the two specimens that are
currently required for each test; and (2) conducting both the initial
and confirmatory tests (if a confirmatory test is required) using the
same EBT in proposed Sec. 26.101(d). As discussed further with respect
to proposed Sec. Sec. 26.95(c) and 26.101(c) and (d), these proposed
changes to the current alcohol testing requirements would improve the
efficiency of alcohol testing while continuing to provide valid,
reliable, and legally defensible results that are necessary to protect
donor's rights under workplace alcohol testing programs. The use of
these improved EBTs is similarly required for confirmatory alcohol
testing and permitted for initial testing under 49 CFR Part 40,
``Procedures for Department of Transportation Workplace Drug and
Alcohol Testing Programs' (65 FR 41944; August 9, 2001). Therefore,
this proposed change would also meet Goal 1 of this rulemaking, which
is to update and enhance the consistency of Part 26 with advances in
other relevant Federal rules and guidelines; Goal 3, which is to
improve the efficiency of FFD programs; and Goal 5, which is to improve
Part 26 by eliminating or modifying unnecessary requirements.
Proposed Sec. 26.91(c) [EBT capabilities] would be added to
specify the required capabilities of the EBTs that licensees and other
entities may use for initial alcohol testing and must use for
confirmatory alcohol tests. The EBT capabilities listed in proposed
Sec. 26.91(c)(1)-(c)(3) are necessary to ensure that a test result can
be uniquely associated with the instrument used, the time of testing,
and the donor. These capabilities are necessary in order to establish
an unimpeachable chain of custody for alcohol test results as well as
permit the accurate identification of any test results that may have
been affected by instrument malfunctions that are discovered later
through additional quality assurance checks. The EBT capabilities
listed in proposed Sec. 26.91(c)(4)-(c)(6) would ensure that test
results will be accurate by permitting collectors to verify that the
instrument is functioning properly before each test and there will be
no carryover effects from previous testing. These capabilities would
improve the effectiveness and efficiency of confirmatory alcohol
testing by limiting the need to cancel test results due to instrument
errors, as required under proposed Sec. 26.91(e)(3). Using EBTs that
have the required capabilities for confirmatory alcohol tests would
protect donors' rights to accurate test results, provide greater
assurance that test results will withstand any legal challenges, and
improve an FFD programs' ability to identify tests that may have been
affected by instrument errors. Therefore, the proposed requirements
would meet Goal 3 of this rulemaking, which is to improve the
effectiveness and efficiency of FFD programs.
Proposed Sec. 26.91(d) [Quality assurance and quality control of
ASDs] would be added to establish quality assurance and quality control
requirements for ASDs. These proposed requirements are necessary to
ensure that initial tests that are conducted using an ASD do not yield
false negative test results. If an ASD provides a false negative test
result, a donor who has a BAC that exceeds the cutoff levels
established in this part would not be detected by the test and may be
permitted to perform the job duties that require him or her to be
subject to this part, thereby creating an unacceptable risk to public
health and safety or the common defense and security. The proposed (and
current) rule would require confirmatory testing if initial alcohol
test results are positive, so false positive test results from an ASD
would lead to confirmatory testing, which would provide accurate test
results. False positive test results reduce the efficiency of FFD
programs and inconvenience donors by causing them to be subject to
unnecessary confirmatory testing, but do not pose any risks to public
health and safety or the common defense and security. However,
confirmatory testing is not required if the result of an initial
alcohol test result is negative. Therefore, the quality assurance and
quality control requirements contained in this proposed paragraph would
be necessary to maintain the effectiveness of FFD programs, which is
Goal 3 of this rulemaking.
Proposed Sec. 26.91(d)(1) would be added to require FFD programs
to implement the most recent version of the quality assurance plan that
a manufacturer has submitted to NHTSA for any ASD that the licensee or
other entity uses for initial alcohol testing. In order to obtain NHTSA
approval for an ASD, the manufacturer of the device must submit a
quality assurance plan that (1) specifies the methods that must be used
for quality control checks, (2) the temperatures at which the ASD must
be stored and used, (3) the shelf life of the device, (4) environmental
conditions (e.g., temperature, altitude, humidity) that may affect the
ASD's performance, (5) instructions for its use and care, (6) the time
period after specimen collection within which the device must be read,
where applicable, and (7) the manner in which the reading is made. The
proposed paragraph would require licensees and other entities who
intend to use an ASD to obtain and implement the most recent version of
the manufacturer's quality assurance plan to ensure that the ASD will
not provide false negative test results from improper storage or use.
As discussed with respect to proposed Sec. 26.91(d), the proposed
provision would be necessary to maintain the effectiveness of FFD
programs that rely on ASDs for initial alcohol testing.
Proposed Sec. 26.91(d)(2) would be added to prohibit licensees and
other entities from using an ASD that fails the quality control checks
that would be specified in the most recent version of the
manufacturer's quality assurance plan or that has passed its expiration
date. This proposed prohibition would be necessary to ensure that test
results from using the ASD are accurate both to protect public health
and safety and donors' rights to accurate test results under the rule.
Proposed Sec. 26.91(d)(3) would be added to require licensees and
other entities to follow the device use and care requirements that
would be specified in proposed paragraph (e) of this section for an ASD
that tests breath specimens. The proposed requirement would be added
because some ASDs test specimens of oral fluids while others test
breath specimens, and some ASDs that test breath specimens also appear
on NHTSA's CPL for evidential breath testing devices (October 3, 2002,
67 FR 62091, and subsequent amendments thereto). Those ASDs that do
test breath specimens and would be used for confirmatory testing have
more detailed quality assurance and quality control
[[Page 50527]]
provisions because their results must be legally defensible.
Proposed Sec. 26.91(e) [Quality assurance and quality control of
EBTs] would establish new quality assurance and quality control
requirements for EBTs. The proposed requirements would be consistent
with those of other Federal agencies that require workplace alcohol
testing and, therefore, would update and enhance the consistency of
Part 26 with advances in other relevant Federal rules and guidelines,
as follows:
Proposed Sec. 26.91(e)(1) would add a requirement that licensees
and other entities must implement the most recent version of the
manufacturer's instructions for the use and care of the EBT consistent
with the quality assurance plan submitted to NHTSA for the EBT,
including the frequency of external calibration checks. An EBT
manufacturer is required to submit to NHTSA a quality assurance plan
that addresses methods used to perform external calibration checks on
the EBT, the tolerances within which the EBT is regarded as being in
proper calibration, and the intervals at which these checks must be
performed. The proposed rule would require licensees and other entities
to perform external calibration checks at the manufacturer's
recommended intervals, at a minimum. These calibration intervals take
into account factors such as frequency of use, environmental conditions
(e.g., temperature, humidity, altitude), and type of operation (e.g.,
stationary or mobile). Therefore, this proposed provision would ensure
that the EBT will not provide false test results from improper storage
or use.
Proposed Sec. 26.91(e)(2) would add a requirement for licensees
and other entities to use only calibration devices appearing on NHTSA's
CPL for ``Calibrating Units for Breath Alcohol Tests'' when conducting
external calibration checks. This proposed requirement is necessary to
ensure that the calibrating units used by licensees and other entities
meet minimum standards and provide accurate results.
Proposed Sec. 26.91(e)(3) would be added to address circumstances
in which an EBT fails an external calibration check. The proposed
paragraph would require the licensee or other entity to cancel any
positive test results from tests that were conducted during the period
since the EBT last passed an external calibration check. This proposed
requirement would protect donors' right to due process under the rule
because positive test results from an EBT that has failed an external
calibration check are questionable and donors should not be subject to
sanctions on the basis of these test results. Because most EBT
manufacturers' recommended intervals are one month, licensees and other
entities may choose to conduct the calibration checks more frequently
in order to avoid the proposed test cancellations, should an EBT fail
an external calibration check. The proposed paragraph would also
require the licensee or other entity to take the EBT out of service. An
EBT that has failed an external calibration check must be taken out of
service to avoid inaccurate reporting of breath alcohol test results
that could result either in the imposition of sanctions on a donor who
has not abused alcohol or the failure to identify a donor who has.
Proposed Sec. 26.91(e)(4) would be added to require that
inspection, maintenance, and calibration of the EBT must be performed
by its manufacturer or a maintenance representative who is certified by
the manufacturer, a State health agency, or other appropriate State
agency. This proposed provision would ensure that inspection,
maintenance, and calibration of EBTs are performed by qualified
personnel for two reasons: (1) To ensure that EBTs used in Part 26
programs continue to provide accurate test results, and (2) because the
experience of other Federal agencies that require workplace alcohol
testing has demonstrated that such stringent EBT inspection,
maintenance, and calibration requirements are necessary to withstand
legal challenges to alcohol test results.
Section 26.93 Preparing for Alcohol Testing
A new Sec. 26.93 [Preparing for alcohol testing] would expand on
current Section 2.4(g)(18) in Appendix A to Part 26, which specifies
procedures for alcohol testing. The proposed rule would provide more
detailed procedures than the current paragraph to increase the
consistency of these procedures with those of other Federal workplace
alcohol testing programs as well as consistency among the alcohol
testing procedures of Part 26 programs. These more detailed
requirements would be added for the reasons discussed in Section IV. B.
Proposed Sec. 26.93(a) would contain more detailed procedures for
implementing the current requirement in the first sentence of current
Section 2.4(g)(18) in Appendix A, which instructs collectors to delay
alcohol breath testing for 15 minutes if the donor has engaged in any
of the activities listed (e.g., smoking, regurgitation of stomach
contents from vomiting). Proposed Sec. 26.93(a)(1)-(a)(6) would
require the collector to provide the donor with more detailed
information about mouth alcohol and the testing process than is
currently required and document that the information is provided.
Providing more detailed requirements for the 15-minute waiting period
would improve the effectiveness and efficiency of the alcohol testing
process by reducing false positive test results that are due to
residual mouth alcohol or other substances that could potentially
trigger a false positive result. Proposed Sec. 26.93(a)(1) would
retain the current requirement for the collector to ask the donor about
behaviors such as eating and drinking that have may have occurred
within the 15 minutes before an alcohol test and add a requirement for
the collector to advise the donor to avoid these activities during the
collection process. Proposed Sec. 26.93(a)(2) would permit alcohol
testing to proceed if the donor states that none of the activities
listed in Sec. 26.93(a)(1) had occurred, while proposed Sec.
26.93(a)(3) would retain the current requirement for a 15-minute
waiting period before a donor could be tested if he or she had engaged
in the activities listed in proposed Sec. 26.93(a)(1). Proposed Sec.
26.93(a)(4) would add a requirement for the collector to explain that
it is to the donor's benefit to avoid the activities listed in Sec.
26.93(a)(1) during the collection process. Proposed Sec. 26.93(a)(5)
would add a requirement for the collector to explain to the donor that
initial and confirmatory alcohol tests will be conducted at the end of
the waiting period regardless of whether the donor has engaged in any
of the activities listed in Sec. 26.93(a)(1). Proposed Sec.
26.93(a)(6) would add a requirement for the collector to document that
the instructions were communicated to the donor. The proposed
additional requirements for the collector to communicate with the donor
about the potential effects on test results of the activities listed in
proposed Sec. 26.93(a)(1) would ensure that donors clearly understand
the reasons for avoiding those activities and the potential
consequences of engaging in them in order to protect their rights to
due process under the rule. The proposed requirement for the collector
to document that the instructions were communicated to the donor would
be necessary to ensure that the collector does not inadvertently omit
the instructions and improve the legal defensibility of the collection
procedure, should a donor challenge it.
[[Page 50528]]
Proposed Sec. 26.93(b) would be added to require collectors to
minimize delays in administering for-cause drug and alcohol tests and
complete alcohol testing before collecting a specimen for drug testing.
These proposed requirements would decrease the likelihood that a
donor's test results would fall below the program's cutoff levels as a
result of metabolic processes over time, which could prevent the
detection of proscribed alcohol consumption or drug use. Delays between
the time at which a donor reports for testing and the time at which
testing occurs would continue to be permitted for tests conducted under
conditions other than for cause, because, in contrast to for-cause
testing, there would be no reason to believe that an individual may
have used drugs or alcohol in violation of the FFD policy. Therefore,
there would be no basis for a concern that metabolic processes may
cause inaccurate test results. The proposed provision would be
consistent with the related regulations of other Federal agencies.
Section 26.95 Conducting an Initial Test for Alcohol Using a Breath
Specimen
Proposed Sec. 26.95 [Conducting an initial test for alcohol using
a breath specimen] would replace the portions of current Section
2.4(g)(18) in Appendix A to Part 26 that specify procedures for
conducting an initial test for alcohol. Collectors would follow the
procedures in this section when using ASDs that test breath specimens
and EBTs. The proposed section would increase the consistency of Part
26 with the procedures of other Federal agencies for workplace alcohol
testing. Consistent with other agencies' procedures, the proposed rule
would eliminate the requirement in current Section 2.4(g)(18) in
Appendix A to Part 26 for collecting a second breath specimen for the
initial alcohol test. The experience of other Federal agencies
indicates that the current Part 26 requirement for two breath specimens
is unnecessary to obtain a valid, reliable, and legally defensible test
result, if the procedures specified in the proposed section are
followed. Therefore, the proposed rule would amend the current
procedures to reduce the burden on FFD programs and donors that is
associated with collecting two breath specimens for the initial alcohol
test, while continuing to ensure that breath alcohol testing provides
accurate results.
Proposed Sec. 26.95(a) would be added to require the collector to
start breath testing as soon as reasonably practical after the donor
indicates that he or she has not engaged in any activities that may
result in the presence of mouth alcohol or after the 15-minute waiting
period, if required. The phrase, ``as soon as reasonably practical,''
would be added to the proposed paragraph in response to stakeholder
comments at the public meetings discussed in Section V. The intent of
the provision is for the collector to conduct the initial alcohol test
as soon as the individual has received the instructions specified in
proposed Sec. 26.93 [Preparing for alcohol testing] in order to ensure
the accuracy of the test result, because delays in conducting the test
increase the possibility that the donor may inadvertently engage in a
behavior that could result in the presence of mouth alcohol as well as
permit the donor's metabolism to lower the alcohol concentration in the
specimen, if the donor has consumed alcohol. However, the stakeholders
noted that when preparing for outages, in which it is sometimes
necessary to test large numbers of individuals, collectors often
provide the instructions in proposed Sec. 26.93 to groups of donors at
the same time and it is not feasible to test each one immediately after
providing the instructions. Therefore, the proposed rule would add the
phrase, ``as soon as reasonably practical,'' to permit reasonable
delays in testing associated with outage planning.
Proposed Sec. 26.95(b)(1) would permit the donor to select the
mouthpiece to be used for testing, at the collector's discretion.
Permitting the donor to select the mouthpiece would not be required,
but may increase the donor's confidence in the integrity of the testing
process by assuring the donor that the selection of the mouthpiece is
random, if he or she is concerned that a collector would attempt to
subvert the testing process by, for example, selecting a mouthpiece
that had been contaminated with alcohol or other means of tampering
with the testing device. The NRC is not aware of any instances in Part
26 programs in which a donor has accused a collector of altering an
alcohol testing device. However, the experience of other Federal
agencies who similarly require workplace alcohol testing indicates that
taking steps to reduce potential donor concerns about the integrity of
the testing process increases donors' willingness to participate in the
testing procedures and reduces the potential for legal challenges.
Proposed Sec. 26.95(b)(2) would instruct the collector to open the
mouthpiece packaging and insert it into the device in view of the
donor. The proposed requirement to insert the mouthpiece into the
device in the view of the donor would be added for the same reason
described with respect to proposed Sec. 26.95(b)(1).
Proposed Sec. 26.95(b)(3) would require the donor to blow into the
mouthpiece for at least 6 seconds in order to obtain an adequate breath
sample. The requirement to obtain the specimen from the end of the
breath exhalation in current Section 2.4(g)(18) in Appendix A to Part
26 would be deleted as unnecessary based upon improvements to breath-
testing technology.
Proposed Sec. 26.95(b)(4) would require the collector to show the
test result to the donor. This proposed requirement is consistent with
current industry practices and is intended to increase donor confidence
in the integrity of the testing process by ensuring that both the donor
and the collector have access to the same information about the donor's
test result. The proposed requirement is consistent with Goal 7 of this
rulemaking, which is to protect the due process rights of individuals
who are subject to Part 26, by ensuring that donors are aware of the
information used by the collector to determine whether an alcohol test
result is positive or negative.
Proposed Sec. 26.95(b)(5) would require the collector to ensure
that the test result record can be associated with the donor and is
maintained secure, consistent with the many provisions throughout the
current and proposed rules that the chain-of-custody must be maintained
for specimens and the associated documentation of test results.
Proposed Sec. Sec. 26.129 and 26.159 [Assuring specimen security,
chain of custody, and preservation] would establish similar
requirements for urine specimens at licensee testing facilities and
HHS-certified laboratories, respectively.
Proposed Sec. 26.95(c) would be added to require the collection of
only one breath specimen for the initial test, unless problems in the
collection require that the collection must be repeated. Problems in
the collection may include, but would not be limited to, device
malfunctions or a donor's inability to provide an adequate breath
specimen on the first try. If a repeat collection is required, the
collector would rely on the result from the first successful collection
in determining the need for confirmatory alcohol testing. If the
procedures specified in this proposed section are followed, relying on
one breath specimen for the initial test, rather than the two required
in the current rule, would increase the consistency of Part 26
collection procedures with those of other Federal
[[Page 50529]]
agencies, consistent with Goal 1 of this rulemaking. The proposed
provision would also reduce the time required for breath specimen
collections without compromising the accuracy, validity, or reliability
of the test results. Therefore, the proposed provision would also meet
Goal 3 of this rulemaking, which is to improve the efficiency of FFD
programs.
Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen
of Oral Fluids
A new Sec. 26.97 [Conducting an initial test for alcohol using a
specimen of oral fluids] would establish requirements for conducting
initial alcohol tests using an ASD for testing oral fluids specimens.
The proposed rule would permit licensees and other entities to rely on
ASDs that test oral fluids for the reasons discussed with respect to
proposed Sec. 26.83(a). The proposed procedures for conducting alcohol
testing with an ASD for testing oral fluids would incorporate the
related requirements from 49 CFR Part 40, ``Procedures for Department
of Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR
41944; August 9, 2001) and would be added to the proposed rule to
ensure that initial alcohol tests of oral fluids provide accurate and
legally defensible test results.
Proposed Sec. 26.97(a) would be added to specify the procedures
that the collector would follow in using an ASD for testing oral
fluids, as follows:
Proposed Sec. 26.97(a)(1) would require the collector to check the
expiration date on the device and show it to the donor. Some devices
degrade during storage. Therefore, this step would be necessary to
assure both the donor and the collector that the device can be expected
to function properly.
Proposed Sec. 26.97(a)(2) would require the collector to open an
individually wrapped or sealed package containing the device in the
presence of the donor. The proposed rule would add the requirement for
the collector to open the package in the presence of the donor for the
reasons discussed with respect to proposed Sec. 26.95(b)(1).
Proposed Sec. 26.97(a)(3) would require the collector to offer the
donor a choice of using the device or having the collector use it. If
the donor chooses to use the device, the collector would be required to
provide instructions for its proper use. The proposed rule would
require the collector to offer the donor the choice of using the device
to increase the donor's confidence in the integrity of the testing
process, as discussed with respect to proposed Sec. 26.95(b)(1).
Proposed Sec. 26.97(a)(4) would require the collector to gather
oral fluids in the proper manner if the donor chooses not to use the
device, or in cases in which a second test is necessary because the
device failed to activate. In addition, the collector would be required
to wear single-use examination or similar gloves while doing so and
change them following each test. Proposed Sec. 26.97(a)(5) would
require the collector to follow the manufacturer's instructions to
ensure that the device has activated. The proposed requirements in
these paragraphs to follow the device manufacturer's instructions for
collecting the specimen and verify that the device has activated would
be added to ensure that the collection is properly conducted. The
proposed requirement to use single-use examination gloves would ensure
that the collector and donor are protected from possible infection from
exposure to body fluids.
Proposed Sec. 26.97(b) would be added to specify the procedures
that the collector would follow if the first attempt to conduct the
test using the ASD fails for any reason, including, but not limited to,
the ASD failing to activate or the device is dropped on the floor.
Proposed Sec. 26.97(b)(1) would require the collector to discard
the device and conduct another test using a new device that has been
under the collector's control if the first attempt fails. The proposed
rule would require the second device used to have been under the
collector's control to ensure that there have been no opportunities for
the donor or another individual to substitute the new device with
another that has been altered to provide a false negative test result.
This proposed requirement would be necessary to protect the integrity
of the collection process.
Proposed Sec. 26.97(b)(2) would require the collector to record
the reason for the new test. The proposed rule would require
documentation of the reason for the new test to ensure that the
information is available, should any questions arise with respect to
the collection procedure in a review conducted under proposed Sec.
26.39 [Review process for fitness-for-duty policy violations] or legal
proceedings.
Proposed Sec. 26.97(b)(3) would require the collector to offer the
donor the choice of using the device or having the collector use it,
unless the collector concludes that the donor was responsible for the
new test needing to be conducted. The proposed rule would require the
collector to offer the donor the choice of using the device for the
reasons discussed with respect to proposed Sec. 26.95(b)(1). The
requirement for the collector to use the device if he or she concludes
that the donor was responsible for the second test needing to be
conducted would enhance the efficiency of the collection procedure by
ensuring that the second collection is conducted properly.
Proposed Sec. 26.97(b)(4) would require the collector to repeat
the collection procedures outlined in proposed Sec. 26.97(a) for the
second collection.
If the second collection attempt fails, proposed Sec. 26.97(c)
would be added to direct the collector to use an EBT to perform the
initial alcohol test instead. The proposed rule would require the
collector to use an EBT to perform the initial test after two failed
attempts at testing oral fluids specimens to ensure that a valid test
result is obtained to enhance the efficiency of the collection
procedure by changing the method used to conduct the test.
If the specimen collection using the ASD for testing oral fluids is
successful, proposed Sec. 26.97(d) would instruct the collector to
follow the device manufacturer's instructions for reading the result
and show the result to the donor. The proposed rule would prohibit the
collector from reading the result sooner than instructed by the device
manufacturer because some devices require several minutes after
specimen collection to provide an accurate result, but no more than 15
minutes in all cases. The proposed requirement for the collector to
show the test result to the donor is intended to increase donor
confidence in the integrity of the testing process by ensuring that
both the donor and the collector have access to the same information
about the donor's test result. The proposed paragraph would also
require the collector to record the test result and that an ASD was
used to document the collection and test and ensure that the
information is available, should any questions arise with respect to
the collection procedure in a review conducted under proposed Sec.
26.39 [Review process for fitness-for-duty policy violations], or legal
proceedings.
In order to protect collectors and donors from any possible
biohazards, proposed Sec. 26.97(e) would be added to prohibit the
reuse of any devices, swabs, gloves; and other materials used in
collecting oral fluids.
Section 26.99 Determining the Need for a Confirmatory Test for Alcohol
A new Sec. 26.99 [Determining the need for a confirmatory test for
alcohol] would amend the existing requirements in current Sec.
26.24(g) and the portion of
[[Page 50530]]
Section 2.7(e)(1) in Appendix A to Part 26 that addresses cutoff levels
for alcohol testing. The proposed rule would amend the current
requirements for consistency with a new approach to determining
positive alcohol test results in proposed Sec. 26.103 [Determining a
confirmed positive test result for alcohol]. The proposed approach
would be adopted because some licensees have not taken appropriate
action when a donor has obtained alcohol test results just below the
current 0.04 percent BAC cutoff level after the donor has been at work
for several hours. A BAC below 0.04 percent after the donor has been at
work for several hours allows very little doubt that the donor has had
an unacceptably high BAC, and has probably been impaired, at some time
during the work period. Therefore, new cutoff levels for alcohol
testing would be established in proposed Sec. Sec. 26.99 and 26.103
that would take into account the average rate at which individuals
metabolize alcohol over time. In proposed Sec. 26.99(a), the cutoff
level for the initial alcohol test result would be decreased from 0.04
to 0.02 percent BAC and a confirmatory alcohol test would be required
if a donor's initial test result is 0.02 percent BAC or higher. In
addition, in proposed Sec. 26.99(b), the collector would be required
to record the time at which the initial alcohol test result is
obtained, so that the length of time during which the donor has been in
a work status could be calculated to determine whether a confirmatory
test result is positive, in accordance with proposed Sec. 26.103. The
proposed changes in the initial alcohol test cutoff level and testing
procedure are necessary to support the provisions of proposed Sec.
26.103, which would require the collector to declare an alcohol test as
positive if the donor's confirmatory test result is 0.03 percent or
higher after the donor has been on duty for one hour, or 0.02 percent
or higher after the donor has been on duty for 2 hours. The revised
lower cutoff level for the initial test of 0.02 percent BAC would
permit licensees and other entities to identify donors who have had a
BAC of 0.04 percent or higher while in a work status, and to initiate
confirmatory testing for those individuals.
Section 26.101 Conducting a Confirmatory Test for Alcohol
A new Sec. 26.101 [Conducting a confirmatory test for alcohol]
would be added to provide detailed procedures for conducting
confirmatory breath alcohol tests. These proposed procedures would
incorporate the related requirements from 49 CFR Part 40, ``Procedures
for Department of Transportation Workplace Drug and Alcohol Testing
Programs'' (65 FR 41944; August 9, 2001), which would be added to the
proposed rule to ensure that confirmatory breath alcohol tests provide
accurate and legally defensible test results when using the EBTs that
would be required in proposed Sec. 26.91(b) [Acceptable evidential
breath testing devices] and relying upon one breath specimen for
confirmatory testing, as would be required in proposed paragraph (c) of
this section.
Proposed Sec. 26.101(a) would require licensees and other entities
to conduct the confirmatory test as soon as possible following the
initial alcohol test, and in all cases, no later than 30 minutes after
the initial test. The proposed rule would add this requirement to
reduce the possibility that alcohol metabolism will cause a
confirmatory test to provide a result falling below the applicable
cutoff level. Current Section 2.4(g)(18) in Appendix A to Part 26 does
not require that confirmatory testing must be conducted as soon as
possible after a positive initial alcohol test result is obtained,
although licensees follow this practice. However, the 30-minute limit
would be added because some FFD program personnel may be tested under
DOT procedures, as permitted in proposed Sec. 26.31(b)(2), and an EBT
that is suitable for confirmatory testing may not be immediately
available at the collection site, such that transport to another
collection site is required. The 30-minute interim period would be
unnecessary at licensees' and other entities' collection sites because
licensees' and other entities' collection sites would have the
capability to conduct confirmatory tests with an EBT, as required under
proposed Sec. 26.87(a). Therefore, except in these unusual
circumstances, licensees and other entities would be expected to
continue their current practice of conducting the confirmatory test
immediately after a donor's initial test result is determined to be
positive.
Proposed Sec. 26.101(b) would be added to specify procedures for
conducting a confirmatory alcohol test.
Proposed Sec. 26.101(b)(1) and (b)(2) would require the collector
to conduct an air blank before beginning the confirmatory test and
verify that the air blank reading is 0.00. These proposed steps are
necessary to ensure that the EBT is functioning properly before the
test begins.
Proposed Sec. 26.101(b)(3) would require the collector to take the
EBT out of service if a second air blank test reading is above 0.00.
This proposed step is necessary because a reading above 0.00 on an air
blank test indicates that the EBT is not functioning properly and may
provide inaccurate test results.
Proposed Sec. 26.101(b)(4)-(b)(7) would be added to specify
requirements for handling the EBT's mouthpiece; reading the test number
displayed on the EBT; blowing into the EBT; and showing, recording, and
documenting the result displayed on the EBT, respectively. The
necessity for these steps would be the same as for those discussed with
respect to the related steps in proposed Sec. 26.95 [Conducting an
initial test for alcohol using a breath specimen]. However, the
proposed rule would not permit the donor to insert the mouthpiece into
the EBT for the confirmatory test, because it is necessary to ensure
that the confirmatory test is conducted strictly in accordance with the
proper procedures to produce a result that meets evidential standards.
Meeting evidential standards would be necessary if any questions arise
with respect to the collection procedure in a review conducted under
proposed Sec. 26.39 [Review process for fitness-for-duty policy
violations], or legal proceedings.
Proposed Sec. 26.101(c) would be added to require that only one
breath specimen must be collected for the confirmatory alcohol test,
unless problems in the collection require that the collection be
repeated. If a repeat collection is required, the collector would rely
upon the result from the first successful collection in determining the
confirmatory test result. As discussed with respect to proposed Sec.
26.95(c), if the procedures specified this proposed section are
followed, relying on one breath specimen for the initial test, rather
than the two required in the current rule, would increase the
consistency of Part 26 collection procedures with those of other
Federal agencies, and reduce the time required for breath specimen
collections without compromising the accuracy, validity, or reliability
of the test results. The proposed paragraph would also prohibit
licensees and other entities from combining or averaging results from
more than one test in order to arrive at the confirmatory test result.
These calculations, which are required in current Section 2.4(g)(18) in
Appendix A to Part 26, would no longer be necessary with use of the
EBTs specified in proposed Sec. 26.91(b). The proposed change would
meet Goal 3 of this rulemaking, which is to improve the efficiency of
FFD programs.
Proposed Sec. 26.101(d) would amend the portion of current Section
2.4(g)(18) in Appendix A of Part 26 that requires using a different EBT
for conducting the confirmatory alcohol test than the EBT that the
collector used for initial alcohol
[[Page 50531]]
testing. The proposed rule would permit the use of the same EBT for
both initial and confirmatory alcohol testing, rather than require the
use of two different EBTs. The licensee or other entity would obtain
one breath specimen for initial alcohol testing and one for
confirmatory testing, if necessary, but would be permitted to conduct
both tests using the same EBT. This proposed change would be made
because improvements in EBT technology assure that valid and reliable
test results may be obtained from a single EBT, if the proposed
specimen collection and quality assurance procedures in this part are
followed. Reducing the number of breath specimens required for alcohol
testing would not only reduce the costs associated with alcohol
testing, but would also reduce the burden on donors that is imposed by
the collection process. Use of the same EBT for initial and
confirmatory testing is consistent with the procedures of other Federal
agencies for workplace alcohol testing.
Section 26.103 Determining a Confirmed Positive Test Result for Alcohol
A new Sec. 26.103 [Determining a confirmed positive test result
for alcohol] would amend the current cutoff level for determining
whether a confirmatory alcohol test result is positive, as specified in
current Sec. 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26.
The proposed rule would establish new cutoff levels that take into
account the length of time the donor has been in a work status for the
reasons discussed with respect to proposed Sec. 26.99 [Determining the
need for a confirmatory test for alcohol]. Proposed Sec. 26.103(a)(1)
would retain the 0.04 percent BAC in current Sec. 26.24(g) and Section
2.7(f)(2) in Appendix A to Part 26 as the cutoff level for a confirmed
positive alcohol test result at any time, regardless of the length of
time the donor has been in a work status. Proposed Sec. 26.103(a)(2)
and (a)(3) would establish new cutoff levels for positive alcohol test
results that are above the 0.02 percent BAC cutoff level on the initial
test and do not meet or exceed the 0.04 percent BAC cutoff level upon
confirmatory testing, but indicate that the donor had a BAC of 0.04
percent or greater while in a work status or had consumed alcohol while
on duty. The cutoff levels and time periods in proposed Sec.
26.103(a)(2) and (a)(3) are based upon the average rate at which normal
metabolic processes reduce an individual's BAC over time, which is
about 0.01 percent BAC per hour. Therefore, a donor whose BAC is
measured as 0.03 percent after the donor has been in a work status for
one hour would have had a BAC of approximately 0.04 percent when he or
she reported for work an hour ago. Through the same metabolic
processes, a donor whose BAC is measured as 0.02 percent after he or
she has been in a work status for 2 hours would also have had a BAC of
approximately 0.04 percent when he or she reported for work 2 hours
ago. These proposed changes would improve the effectiveness of FFD
programs by ensuring that confirmatory alcohol testing identifies
donors who have been impaired from alcohol use while on duty and,
therefore, may have posed a risk to public health and safety.
Proposed Sec. 26.103(b) would be added to strengthen FFD programs
by requiring licensees and other entities to address circumstances in
which a donor's confirmatory alcohol test result is greater than 0.01
percent BAC when the individual has been in a work status for 3 hours
or more, but his or her BAC falls below the cutoff levels in proposed
Sec. 26.103(a). The proposed rule would require the collector to
declare the test as negative because some of the EBTs that licensees
and other entities would be permitted to use for confirmatory alcohol
testing under the proposed rule have not been thoroughly evaluated by
NHTSA for accurately estimating BAC levels below 0.02 percent. However,
if an individual has an alcohol test result above 0.01 percent BAC, and
has been in a work status for 3 hours or more, the test result would
provide a reason to believe that the individual has been impaired while
on duty. Therefore, the proposed provision would require the licensee
or other entity to ensure that the donor's alcohol use is evaluated, a
determination of fitness is performed, and that the results of the
determination of fitness indicate that the donor is fit to safely and
competently perform his or her duties before the individual is
permitted to perform the duties that require him or her to be subject
to this part after testing. This proposed change would strengthen the
effectiveness of FFD programs by ensuring that the alcohol use of
individuals who may have been impaired when reporting for duty is
assessed to determine whether such individuals' alcohol use is
problematic and may pose a future risk to public health and safety and
the common defense and security.
Current Section 2.4(g)(19) in Appendix A to Part 26, which
establishes requirements for collecting a blood specimen for alcohol
testing, would be deleted in its entirety because blood testing for
alcohol, at the donor's discretion, would no longer be permitted in the
proposed rule. The reasons for eliminating blood testing for alcohol
from the proposed rule discussed with respect to proposed Sec.
26.83(a).
Section 26.105 Preparing for Urine Collection
A new Sec. 26.105 [Preparing for urine collection] would be added
to describe the preliminary steps for collecting a urine specimen for
drug testing. This proposed section would reorganize the requirements
in current Section 2.4(g)(5)-(g)(7) in Appendix A to Part 26 by
separating alcohol and urine specimen collection procedures into
separate sections of the proposed rule for organizational clarity. The
proposed section would also establish several new requirements that
would be added to meet Goal 1 of this rulemaking, which is to update
and enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Proposed Sec. 26.105(a) would revise current Section 2.4(g)(5) in
Appendix A to Part 26, which requires the donor to remove any
unnecessary outer garments and belongings that might conceal items or
substances that could be used to tamper with a urine, breath, or blood
specimen. The proposed paragraph would eliminate the references to
blood and breath specimens in the current paragraph. Reference to blood
specimens would be eliminated because blood testing for alcohol, at the
donor's discretion, would no longer be permitted in the proposed rule,
as discussed with respect to proposed Sec. 26.83(a). Reference to
breath specimens would be eliminated in the proposed paragraph because
the proposed rule would present requirements related to preparing for
alcohol testing in a separate section, proposed Sec. 26.93 [Preparing
for alcohol testing], for organizational clarity.
Proposed Sec. 26.105(b) would be added to require the donor to
empty his or her pockets and display the items contained in them. The
proposed requirement for the collector to examine the contents of the
donor's pockets would increase the likelihood of detecting items (e.g.,
a vial of powdered urine, bleach, a portable heating unit, a false
penis or any other tube or device that may be used to replicate the
function of urinary excretion) that could be used to adulterate or
substitute the specimen in a subversion attempt. The collector would be
required to use his or her judgment in determining whether an item
found in the donor's pockets indicates a clear intent to attempt to
subvert the testing process. For example, whereas a container of urine
[[Page 50532]]
found in a donor's pocket would be clear evidence of an intent to
subvert the testing process, a container of eye drops, which could be
used to adulterate the specimen, would, in most cases, be unlikely to
indicate an intent to subvert the testing process. Should the collector
identify an item that indicates a possible intent to subvert the
testing process, the proposed paragraph would require him or her to
contact the FFD program manager or MRO in order to obtain direction
regarding the need for a directly observed collection. If the collector
identifies an item that could be used to tamper with the specimen, but
does not indicate an intent to subvert testing, then the collector
would secure the item and continue with the collection. These proposed
requirements would be added to meet Goal 1 of this rulemaking, which is
to update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines, as well as Goal 3 of this
rulemaking, which is to improve the effectiveness of FFD programs, by
improving the ability of the collector to identify attempts to subvert
the drug testing process. The proposed requirement for the donor to
permit the collector to make this examination would be added in
response to stakeholder requests at the public meetings discussed in
Section V to ensure that donors understand that they must cooperate
with the examination.
Proposed Sec. 26.105(c) would retain current Section 2.4(g)(6) in
Appendix A to Part 26, which requires the individual to be instructed
to wash his or her hands prior to urination. The proposed rule would
make two minor editorial changes to the current provision for clarity
in the language of the proposed rule. The proposed rule would clarify
that the collector is to instruct the donor to wash and dry his or her
hands and would replace the term, ``individual,'' with the term,
``donor.''
Proposed Sec. 26.105(d) would retain current Section 2.4(g)(7) in
Appendix A to Part 26, which requires the donor to remain in the
presence of the collection site person and not to have access to any
source of water or other materials that could be used to tamper with
the specimen. The proposed rule would make two minor editorial changes
to the current provision for clarity in the language of the rule. The
proposed rule would replace the term, ``collection site person,'' with
the simpler term, ``collector,'' and the term, ``individual,'' with the
term, ``donor.''
Proposed Sec. 26.105(e) would be added to permit the donor, at the
collector's discretion, to select the specimen collection container
that he or she will use. Permitting the donor to select the collection
kit would not be required, but may increase the donor's confidence in
the integrity of the testing process by assuring the donor that the
selection of the collection kit is random, if he or she is concerned
that a collector would attempt to subvert the testing process by, for
example, selecting a kit that had been contaminated with a substance
that would produce a positive or adulterated test result in order to
entrap the donor. The importance of providing assurance to the donor
regarding the integrity of the collection process is discussed with
respect to proposed Sec. 26.95(b)(1). The proposed paragraph would
also prohibit the donor from taking collection kit materials (such as
the specimen label) other than the collection container into the
private area used for urination in order to ensure that a donor could
not tamper with the other collection kit materials and thereby disrupt
the chain of custody for the urine specimen. The proposed paragraph
would be consistent with the related requirements of other Federal
agencies and so would meet Goal 1 of this rulemaking, which is to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Section 26.107 Collecting a Urine Specimen
Proposed Sec. 26.107 [Collecting a urine specimen] would amend
current Section 2.4(g)(8), (g)(9), and (g)(12) in Appendix A to Part 26
to update Part 26 urine specimen collection procedures and incorporate
advances in other relevant Federal rules and guidelines, consistent
with Goal 1 of this rulemaking.
Proposed Sec. 26.107(a)(1) would be added to specify the
instructions that the collector would be required to provide to the
donor. The proposed paragraph would require the collector to instruct
the donor to go into the room or stall used for urination, provide a
specimen of the quantity that has been predetermined by the licensee or
other entity, not flush the toilet, and return with the specimen as
soon as the donor has completed the void. The proposed rule would
require the collector to provide these instructions to the donor so
that the donor would understand his or her responsibilities with
respect to the urine collection procedure. In addition, the
instructions would be necessary to implement other provisions of the
proposed rule, as follows: The quantity of urine that the collector
would instruct the donor to provide would be based upon the
requirements of the licensee's or other entity's drug testing program,
as discussed with respect to proposed Sec. 26.109 [Urine specimen
quantity]. The collector would instruct the donor not to flush the
toilet so that the collector may inspect the private area in which the
donor voided after receiving the specimen, as discussed with respect to
proposed paragraph (c) of this section. The collector would instruct
the donor to return with the specimen as soon as the donor has
completed the void in order to minimize the possibility that the urine
specimen would cool and its temperature would fall below the acceptable
specimen temperature range specified in proposed Sec. 26.111(b).
Proposed Sec. 26.107(a)(1) would further amend current Section
2.4(g)(8) in Appendix A to Part 26, which states that the individual
may provide his/her urine specimen in the privacy of a stall or
otherwise partitioned area that protects individual privacy. For
clarity, the proposed paragraph would replace ``may'' in the current
rule with ``shall'' to indicate that the area in which the donor will
urinate must provide for individual privacy. The proposed rule would
also add an exception to the current requirement for privacy in the
case of a directly observed collection. This proposed change would be
made for greater accuracy in the language of the rule, because the
requirement for individual privacy would not apply in the case of a
directly observed collection, as discussed with respect to proposed
Sec. 26.115 [Collecting a urine specimen under direct observation].
Proposed Sec. 26.107(a)(2) would be added to further emphasize the
requirement in current Section 2.4(g)(8) in Appendix A to Part 26 that
donors must be provided with individual privacy when providing a urine
specimen. The proposed paragraph would require that, unless the
specimen is to be collected under direct observation, no one other than
the donor may go into the private area in which the donor will urinate.
Although the NRC is not aware of any instances in Part 26 programs in
which the current requirement for individual privacy has been
compromised, the experience of other Federal agencies has indicated
that such emphasis is necessary.
Proposed Sec. 26.107(a)(3) would permit the collector to set a
reasonable time limit for the donor to urinate. Rather than
establishing a specific time limit, the proposed rule would permit the
collector to rely on his or her professional judgment in order to
ensure that individuals who may experience difficulty in voiding have
sufficient time to provide a specimen, while also
[[Page 50533]]
permitting collectors to prevent donors from disrupting the testing
process by taking an unduly long time to provide a specimen. Proposed
training and qualification requirements to ensure that collectors are
able to exercise professional judgment appropriately would be specified
in proposed Sec. 26.85 (a). At the public meetings discussed in
Section V, stakeholders reported incidents in which donors appeared to
be attempting to disrupt the testing process by spending an unduly long
time providing a specimen and challenged the collector's authority to
set a time limit. The proposed paragraph would clarify that collectors
have the authority to set a reasonable time limit for voiding. In
addition, the proposed paragraph would increase the consistency of Part
26 with the procedures implemented by other Federal agencies,
consistent with Goal 1 of this rulemaking.
Proposed Sec. 26.107(b) would amend current Section 2.4(g)(9) in
Appendix A to Part 26, which requires the collector to note any unusual
behavior or appearance in the permanent record book and on the custody-
and-control form. The proposed paragraph would clarify the intent of
the current requirement, which has raised implementation questions from
licensees, by specifying that the collector must pay careful attention
to the donor during the collection process for the purpose of noting
any conduct that may indicate an attempt to tamper with the specimen.
The proposed paragraph would also provide examples of the types of
behavior that may indicate a subversion attempt and require the
collector to contact FFD program management if such behavior is
observed. The proposed rule would require FFD program management to
determine whether a directly observed collection is necessary under
proposed Sec. 26.115 [Collecting a urine specimen under direct
observation].
Proposed Sec. 26.107(c) would be added to specify the actions to
be taken by the collector and donor to complete the specimen collection
procedure. The first sentence of proposed Sec. 26.107(c) would retain
the existing instruction in current Section 2.4(g)(12) in Appendix A to
Part 26, which prohibits the donor from washing his or her hands until
the specimen has been delivered to the collector. The proposed
paragraph would also add a requirement for the collector to inspect the
private area for any evidence of a subversion attempt prior to flushing
the toilet. This proposed additional requirement would be consistent
with existing industry practices and the procedures of other Federal
agencies. In addition, it may increase the likelihood of detecting
subversion attempts from which physical evidence may remain in the
toilet bowl or private area where the donor voided, which could
include, but would not be limited to, an empty vial that contains an
adulterant, powdered urine spilled on the floor, or the remains of an
adulterant in the toilet bowel.
Section 26.109 Urine Specimen Quantity
A new Sec. 26.109 [Urine specimen quantity] would amend current
Section 2.4(g)(11) in Appendix A to Part 26, which establishes 60
milliliters (mL) as the minimum quantity of urine that an FFD program
must collect from donors and the procedures to be followed if a donor
is unable to provide the specified quantity.
Proposed Sec. 26.109(a) would introduce a new term, ``the
predetermined quantity.'' The predetermined quantity of urine that a
donor would be requested to provide would be established by the
licensee or other entity, depending upon the characteristics of the
licensee's or other entity's testing program. The proposed rule would
require the predetermined quantity to include at least 30 milliliters
(mL) of urine, but licensees and other entities could request a larger
quantity of urine, if the specimen will be initially tested at a
licensee testing facility, if testing will be conducted for additional
drugs beyond those required in proposed Sec. 26.31(d)(1), if split
specimen procedures will be followed, and if the licensee's or other
entity's program includes some combination of these characteristics.
The proposed paragraph would establish 30 mL as the basic quantity
of urine that donors must provide for a testing program that does not
include initial tests at a licensee testing facility, does not test for
additional drugs, and does not follow split specimen procedures. The 60
mL quantity that is required in current Section 2.4(g)(11) in Appendix
A to Part 26 would be reduced to 30 mL to decrease the burden on
donors, while ensuring that a sufficient quantity of urine is available
to complete initial validity and drug tests, confirmatory validity and
drug tests (if required), and any retests that may be requested by the
donor and authorized by the MRO under proposed Sec. 26.165(b). NRC
staff discussions with representatives of HHS-certified laboratories
indicated that advances in testing technologies allow for these minimum
testing and retesting procedures to be completed on a 30 mL specimen.
Therefore, a 60 mL specimen would no longer be necessary to achieve the
NRC's minimum objectives of conducting validity and drug tests on each
specimen for the five classes of drugs specified in proposed Sec.
26.31(d)(1), as well as retesting of the specimen, if required.
Proposed Sec. 26.109(a) would also specify the additional quantity
of urine, above the basic 30 mL, to be collected when the testing
program follows split specimen procedures. Licensees and other entities
would be required to collect an additional 15 mL for transfer into
Bottle B of a split specimen for storage and possible testing. (As
discussed with respect to proposed Sec. 26.113(b), the proposed rule
would replace the terms, ``primary specimen'' and ``split specimen,''
in the current rule with the terms, ``Bottle A'' and ``Bottle B,'' for
clarity in the language of the rule and consistency with the
terminology used by other Federal agencies.) This additional 15 mL
would be sufficient to permit the HHS-certified laboratory to conduct
validity and drug tests of the specimen in Bottle B, at the donor's
request, and is consistent with the quantity required in the related
provisions of other Federal agencies. Therefore, if a licensee's or
other entity's testing program follows split specimen procedures, but
does not include initial tests at the licensee testing facility or
testing for additional drugs beyond those specified in proposed Sec.
26.31(d)(1), then the predetermined quantity for this testing program
would be 45 mL (30 mL for basic testing + 15 mL for the split
specimen). The predetermined quantity would be larger than 45 mL if the
testing program also includes initial tests at a licensee testing
facility and testing for additional drugs.
Proposed Sec. 26.109(a) would also permit licensees and other
entities to include in the predetermined quantity the additional amount
of urine that would be necessary to support testing for additional
drugs beyond those specified in proposed Sec. 26.31(d)(1). Licensees
and other entities would consult with the HHS-certified laboratories
they use to identify the quantity of urine required to test for the
additional drugs. For example, if the licensee's or other entity's
testing program does not include initial tests at a licensee testing
facility and does not follow split specimen procedures, then the
predetermined quantity for that testing program would consist of the 30
mL basic quantity plus the additional amount of urine needed to test
for additional drugs. As another example, if a licensee's or other
entity's testing program includes initial tests at a
[[Page 50534]]
licensee testing facility, follows split specimen procedures, and tests
for additional drugs, then the predetermined quantity would consist of
the 30 mL basic quantity plus 15 mL for the split specimen plus the
additional amount required to test for additional drugs.
Proposed Sec. 26.109(a) would also permit licensees and other
entities to include in the predetermined quantity the additional amount
of urine that is necessary to perform initial validity and drug tests
at the licensee testing facility, if initial tests are performed at the
licensee testing facility. For example, one licensee testing program
currently requires an additional 10 mL of urine for initial testing at
the licensee testing facility, but does not test for additional drugs
or follow split specimen procedures. In this program, the predetermined
quantity that collectors would request the donor to provide is 40 mL.
As another example, if a licensee's or other entity's testing program
includes initial tests at the licensee testing facility, does not test
for additional drugs, and follows split specimen procedures, the
predetermined quantity could be 55 mL (30 mL for basic testing + 15 mL
for the split specimen + 10 mL for initial testing at the licensee
testing facility). If this program also tests for additional drugs, the
predetermined quantity could be larger than 55 mL.
Proposed Sec. 26.109(b) would be added to establish the actions
that the collector must take if a donor provides a specimen that is
less than the 30 mL basic quantity. NRC staff discussions with
representatives of HHS-certified laboratories indicated that 30 mL is
sufficient to meet the NRC's primary objectives of detecting drug use
and subversion attempts through initial validity and drug testing, and
for confirmatory validity and drug tests, if required, at an HHS-
certified laboratory for the panel of drugs for which testing is
required in proposed Sec. 26.31(d)(1). The 30 mL quantity would also
ensure that sufficient urine is available for retesting the specimen
for validity and for drugs and drug metabolites, should the donor
request such retesting, as permitted in proposed Sec. 26.165(b).
However, the 30 mL basic quantity would be insufficient to permit
testing for additional drugs, initial testing at licensee testing
facilities, or splitting the specimen, which are not required under
this part.
Proposed Sec. 26.109(b)(1) would amend the portions of current
Section 2.4(g)(11) in Appendix A to Part 26 that relate to collector
actions if a donor provides an insufficient specimen. The proposed
paragraph would require the collector to ``encourage'' the donor to
drink a reasonable amount of liquid in order to provide a specimen of
at least 30 mL, rather than ``allow'' the donor to drink additional
liquid as currently required. This proposed change would be made to
enhance the efficiency of FFD programs, consistent with Goal 3 of this
rulemaking, by potentially reducing the time required to obtain a
specimen of the required quantity from the donor and, thereby, to
complete the collection, should the donor choose to comply. However,
the proposed paragraph would establish a limit on the amount of liquid
that the individual would be permitted to consume to avoid the
potential for ``water intoxication,'' which is a physical response to
consuming too many liquids that may cause harm to the donor. The
proposed limit of 24 ounces of water over a 3-hour period would be the
same limit imposed in the HHS Guidelines, and would be conservative, in
order to ensure that individuals who may have a medical condition that
makes them more subject to water intoxication, such as some forms of
renal disease or taking some medications, would not be placed at-risk.
The proposed rule would retain the current requirement in Section
2.4(g)(11) in Appendix A to Part 26 to collect successive specimens in
separate containers.
Proposed Sec. 26.109(b)(2) would be added to require the collector
to end the specimen collection process as soon as the donor provides a
specimen of at least 30 mL in a subsequent attempt. This proposed
requirement would reduce the burden on donors who may have some
difficulty providing a urine specimen, while meeting the NRC's
objectives of obtaining a specimen of sufficient size to support
initial and confirmatory validity and drug testing, as well as
retesting of the specimen.
Proposed Sec. 26.109(b)(2) would also specify that the licensee or
other entity may not impose any sanctions if a donor provides a
subsequent specimen that is less than the licensee's or other entity's
predetermined quantity, as long as the specimen quantity is at least 30
mL. Sanctions for failing to provide sufficient urine to support
initial testing at the licensee's testing facility, split specimen
procedures, or testing for additional drugs would be inappropriate,
because a specimen of at least 30 mL is sufficient to meet the NRC's
objectives and, therefore, could not be considered a refusal to test.
Proposed Sec. 26.109(b)(2) would also require the collector to
forward a subsequent specimen that is greater than 30 mL, but less than
the licensee's or other entity's predetermined quantity, to the HHS-
certified laboratory for testing, rather than permit the specimen to be
tested at the licensee testing facility. This proposed provision is
necessary to ensure that a sufficient quantity of urine is available
for validity and drug testing and retesting at the HHS-certified
laboratory, if required, consistent with the NRC's objectives. If the
subsequent specimen is equal to or greater than the licensee's or other
entity's predetermined quantity, however, the licensee or other entity
would be permitted to follow the FFD program's normal testing
procedures. Following normal testing procedures in this instance would
be permissible because there would be sufficient urine to implement the
FFD program's testing procedures (e.g., split specimen procedures,
testing for additional drugs, initial testing at a licensee testing
facility), while continuing to ensure that sufficient urine is
available for testing and retesting at the HHS-certified laboratory, if
required.
Proposed Sec. 26.109(b)(3) would be added to require the
implementation of ``shy bladder'' procedures if a donor is unable to
provide a 30 mL specimen within 3 hours of the initial attempt to
provide a specimen, for the reasons discussed with respect to proposed
Sec. 26.119 [Determining shy bladder]. Requirements for implementing
``shy bladder'' procedures would be contained in that proposed section.
Proposed Sec. 26.109(b)(4) would be added to establish additional
requirements for specimen collections when a donor provides a specimen
of less than 30 mL, as follows:
The proposed paragraph would eliminate the requirement in current
Section 2.4(g)(11) in Appendix A to Part 26 to combine successive
specimens from a donor in order to obtain a specimen of 60 mL. The
proposed rule would prohibit the practice of combining specimens to
ensure that successive specimens neither contaminate nor dilute a
specimen that will be tested. In addition, the proposed prohibition
would increase the consistency of Part 26 with the related requirements
of other Federal agencies, which is Goal 1 of this rulemaking.
Proposed Sec. 26.109(b)(4) would also require the collector to
discard any specimens of less than 30 mL unless there is reason to
believe that a specimen may have been altered. Examples of reasons to
believe that a donor may have attempted to alter the specimen could
include, but would not be limited to: (1) Observation of powder (that
could be an adulterant or powdered urine) spilled in the private
[[Page 50535]]
area in which the donor urinated or on the donor's clothing; (2)
unexpected sounds from the private area while the donor should be
urinating, such as the sound of something being unwrapped or dropping
to the floor; (3) observation that the donor's pocket appears to
contain an item that was not visible before the donor entered the
private area (that the donor may have previously had taped to his
body); and (4) an unusual color or lack of clarity in the urine
specimen. The proposed rule would require the collector to discard
specimens of less than 30 mL when there is no reason to believe that
the specimens had been subject to tampering because they would not be
used for testing and there would be no reason to retain them.
If the collector suspects that a specimen has been altered and the
suspect specimen is greater than 15 mL, the proposed rule would require
the collector to forward the suspect specimen to the HHS-certified
laboratory for testing, consistent with current Section 2.4(g)(16) in
Appendix A to Part 26. NRC staff discussions with representatives of
HHS-certified laboratories indicate that 15 mL is the minimum quantity
necessary for HHS-certified laboratories to perform the initial and
confirmatory (if necessary) validity and drug testing required in this
part, although it would be insufficient to support retesting of the
specimen at the donor's request. In these circumstances, in which the
collector has observed donor conduct or specimen characteristics that
indicate there is a reason to believe that the donor may have altered
the specimen, the NRC's interest in assuring that the testing process
is not subverted would take precedence over the individual's ability to
request retesting of the specimen. Any results of validity testing that
confirm that the specimen was adulterated or substituted, in
combination with the collector's observations, would provide clear
evidence that a donor had tampered with the specimen and had thereby
attempted to subvert the testing process.
The proposed paragraph would also amend current Section 2.4(g)(17)
in Appendix A to Part 26, which requires a directly observed collection
whenever there is a reason to believe that a donor has or may attempt
to alter a specimen. The proposed paragraph would require the collector
to contact FFD program management to determine whether a directly
observed collection is required, but would not require a directly
observed collection. At the public meetings discussed in Section V, the
stakeholders requested flexibility in the decision to collect another
specimen under direct observation. They noted that there have been
numerous instances in which a collector identified incontrovertible
evidence that the donor intended to or had tampered with a specimen and
that, in such cases, drug testing would not provide additional
information that justifies the costs associated with conducting a
directly observed collection and testing the additional specimen. The
NRC believes that the presence of drugs and drug metabolites in a
specimen that is collected under direct observation would establish a
clear motive for an alleged attempt to tamper with a specimen and would
add further evidence supporting the imposition of sanctions on the
donor for attempting to subvert the testing process. However, the NRC
agrees with the stakeholders that such additional evidence is
unnecessary when there is incontrovertible evidence that the donor
intends to or has attempted to tamper with a specimen. Therefore, the
proposed rule would permit FFD program management to determine whether
an additional specimen collection under direct observation would be
conducted. This proposed change would be made to meet Goal 3 of this
rulemaking, which is to improve the efficiency of FFD programs, by
reducing the number of directly observed collections required under the
rule.
Section 26.111 Checking the Validity of the Urine Specimen
A new Sec. 26.111 [Checking the validity of the urine specimen]
would amend current requirements for assessing specimen validity at the
collection site, which appear in Section 2.4(g)(13)-(g)(17) in Appendix
A to Part 26. In general, the changes contained in the proposed section
would be made to meet Goal 1 of this rulemaking, which is to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Proposed Sec. 26.111(a) would amend current Section 2.4(g)(13) in
Appendix A to Part 26, which requires the collector to measure the
temperature of the specimen immediately after the urine specimen is
collected. The proposed paragraph would require the collector to
measure the temperature of any specimen that is 15 mL or more. The
proposed rule would not require measuring the temperature of smaller
specimens because the collector would be required to discard them, as
discussed with respect to proposed Sec. 109(b)(4). The proposed
paragraph would also amend the third sentence of current Section
2.4(g)(13) to indicate that, if the ambient temperature is low or the
specimen is small, it may be necessary to measure the specimen
temperature sooner than 4 minutes after the collector receives the
specimen from the donor. A low ambient temperature could cool the
specimen more rapidly than normal room temperatures, resulting in an
inaccurate temperature reading. Specimens of less than 30 mL will cool
more rapidly than specimens of 30 mL or more, so that smaller specimens
may also produce inaccurate temperature readings. Therefore, the
proposed rule would add an admonition for the collector to expedite the
temperature measurement process if the collection is occurring in an
environment below normal room temperatures or the specimen is small.
Proposed Sec. 26.111(b) would replace current Section 2.4(g)(14)
in Appendix A to Part 26, which establishes the acceptable specimen
temperature range and requires conducting a second specimen collection
under direct observation if a specimen's temperature falls outside the
acceptable range. The proposed rule would increase the range of
acceptable specimen temperatures from 90.5[deg]F-99.8[deg]F in the
current provision to 90[deg]F-100[deg]F for consistency with the
temperature range specified in the HHS Guidelines. The proposed wider
acceptable temperature range would provide increased protection against
false low or false high temperature readings and, therefore, would
protect donors from the imposition of sanctions based upon inaccurate
specimen temperature readings. The proposed paragraph would retain the
requirement in the current rule for the collector to offer the donor
the opportunity to provide a measurement of body temperature, but a
measure of oral temperature would no longer be specified. New
technologies for obtaining body temperature, such as digital
measurement in the ear canal, would also be permitted, because the new
technologies provide results more quickly that are at least as accurate
as oral thermometers. The portion of current Section 2.4(g)(14) that
specifies collector actions if there is a reason to believe that the
individual may have tampered with the specimen would be moved to
proposed Sec. 26.111(d) for organizational clarity.
Proposed Sec. 26.111(c) would amend current Section 2.4(g)(15) in
Appendix A to Part 26, which requires the collector to inspect the
specimen's color, determine whether there are any signs of
contaminants, and record any unusual findings in the permanent
[[Page 50536]]
record book. The proposed rule would amend this requirement by deleting
reference to the permanent record book and requiring the collector to
use the custody-and-control form for recording this information. This
change would be made because the proposed rule would no longer require
collection sites to maintain a permanent record book, consistent with
the elimination of the requirement to maintain a permanent record book
in the HHS Guidelines. The proposed rule would also make minor
editorial revisions to the current provision by incorporating the
related language from the HHS Guidelines. These proposed changes would
be made to meet Goal 1 of this rulemaking, which is to update and
enhance the consistency of Part 26 with the regulations of other
Federal agencies.
Proposed Sec. 26.111(d) would replace and revise the first
sentence of current Section 2.4(g)(14) in Appendix A to Part 26, which
requires a second specimen to be collected under direct observation if
the temperature of the first specimen submitted by a donor falls
outside of the acceptable specimen temperature range. The proposed
paragraph would eliminate the requirement for a second specimen
collection under direct observation if the specimen temperature falls
outside of the required range, although licensees and other entities
could, at their discretion, continue this practice. Instead, the
proposed provision would require the collector to contact the FFD
program manager, if the collector has a reason to believe the donor has
attempted to subvert the testing process based upon observed donor
behavior, the specimen temperature, unusual specimen characteristics,
or other observations. The FFD program manager, at his or her
discretion, would consult with the MRO to determine whether the
collector's observations provide sufficient evidence that a subversion
attempt has occurred to warrant the imposition of sanctions. If the MRO
and/or FFD program manager determine that a subversion attempt has
occurred on the basis of the collector's observations, the licensee or
other entity would be permitted to impose the sanctions for a
subversion attempt in proposed Sec. 26.75(b) without conducting a
directly observed collection. However, at the FFD program manager's or
the MRO's discretion, a second specimen may be collected under direct
observation. The proposed rule would permit the second specimen to be
collected under direct observation to provide further information to
assist the MRO in determining whether or not a subversion attempt has
occurred. For example, positive drug test results from a second
specimen that was collected under direct observation would provide
additional evidence that the donor had attempted to tamper with his or
her first specimen to hide drug use. This proposed change would be made
in response to stakeholder requests, for the reasons discussed with
respect to proposed Sec. 26.109(b)(4).
Proposed Sec. 26.111(e) would revise current Section 2.4(g)(16) in
Appendix A to Part 26, which requires that all urine specimens that are
suspected of being adulterated or diluted must be forwarded to the HHS-
certified laboratory for testing. The proposed paragraph would add
suspicion that a specimen has been substituted as a third reason for
forwarding the specimen to the HHS-certified laboratory. As discussed
with respect to proposed Sec. 26.31(d)(3)(i), substitution entails
replacing a valid urine specimen with a drug-free specimen. This
proposed addition would be made for consistency with the addition of
substitution to the proposed rule as another method of attempting to
subvert the testing process for which licensees and other entities
would be required to impose sanctions, as discussed with respect to
proposed Sec. 26.75(b).
The proposed paragraph would also specifically prohibit testing the
suspect specimen at a licensee testing facility for three reasons,
which are to: (1) Limit the potential for specimen degradation during
the time period required to conduct testing at the licensee testing
facility; (2) decrease the time required to obtain confirmatory
validity test results if the specimen, in fact, has been altered; and
(3) ensure that a sufficient quantity of urine is available for
conducting validity tests at more than one HHS-certified laboratory if,
for example, the specimen contains a new adulterant or an adulterant
that the licensee's or other entity's primary laboratory is not capable
of identifying [see proposed Sec. 26.161(g)]. Only suspect specimens
of 15 mL or more would be sent for testing, rather than all specimens.
This proposed lower limit on specimen quantity would be added in order
to ensure that there would be sufficient urine available for the HHS-
certified laboratory to conduct all of the validity and drug tests on
the specimen that would required under this part.
Proposed Sec. 26.111(f) would require collectors and the HHS-
certified laboratory to preserve as much of the specimen as possible.
This proposed requirement would be added to provide increased assurance
that a sufficient quantity of urine would be available to support
further testing, in the event that further testing of the specimen is
necessary, and to enhance the consistency of Part 26 with the related
provisions of other Federal agencies.
Proposed Sec. 26.111(g) would be added to inform donors and
collectors of the characteristics of a specimen that is acceptable for
testing at an HHS-certified laboratory. The proposed paragraph would
incorporate the related provision from the HHS Guidelines.
Section 26.113 Splitting the Urine Specimen
Proposed Sec. 26.113 [Splitting the urine specimen] would update
the requirements in current Sections 2.4(g)(20) and 2.7(j) in Appendix
A to Part 26, which address collection site procedures for split
specimens, and group them together in one section within the proposed
rule for organizational clarity.
Proposed Sec. 26.113(a) would retain the first sentence of current
Section 2.7(j) in Appendix A to Part 26, which permits licensees to
follow split specimen procedures. The proposed rule would revise the
current sentence in the active voice for increased clarity in the
language of the rule.
Proposed Sec. 26.113(b) would be added to group together in one
paragraph, for organizational clarity, the steps that the collector and
donor must follow for the split-specimen collection procedure, which
are embedded in current Section 2.4(g)(20) and portions of Section
2.7(j) in Appendix A to Part 26. The proposed rule would also replace
the terminology used in the current rule that refers to the split
specimen as an ``aliquot,'' and use the terms, ``Bottle A'' and
``Bottle B,'' to refer to the primary and split specimen, respectively.
This proposed change would be made for increased clarity in the
language of the rule and consistency with the terminology used in other
relevant Federal rules and guidelines.
Proposed Sec. 26.113(b)(1) would require the collector to instruct
the donor to urinate into either a specimen bottle or a specimen
container. This step would be added to clarify that the donor is not
required to divide a specimen into Bottle A and Bottle B while
urinating. The proposed paragraph would incorporate the related
provision in the HHS Guidelines.
Proposed Sec. 26.113(b)(2) would amend the portions of current
Section 2.7(j) in Appendix A to Part 26 that specify the amount of
urine to be contained in the split specimen bottles. The proposed rule
would replace the implied requirements in the second and third
sentences of Section 2.4(j), which refer to the split specimens as
``halves'' of the specimen that was collected, with
[[Page 50537]]
updated requirements that would be consistent with those established in
proposed Sec. 26.109 [Urine specimen quantity] and the related
provisions in the HHS Guidelines. The proposed paragraph would require
the collector to ensure that Bottle A contains 30 mL of urine and that
Bottle B contains 15 mL. As discussed with respect to proposed Sec.
26.109, advances in urine testing technologies since Part 26 was first
promulgated permit a reduction in the quantities of urine that must be
collected from donors in order to conduct the testing that would be
required under this part. Therefore, 30 mL of urine is now a sufficient
quantity for conducting all of the testing that may be required under
this part, while 15 mL is sufficient for any retesting that a donor may
request.
The proposed paragraph would also specify that the specimen in
Bottle A would be used for drug and validity testing and that, even if
there is less than 15 mL of urine available for Bottle B after the
collector ensures that Bottle A contains 30 mL, the specimen in Bottle
A must be subject to testing anyway. These clarifications would be
added to the proposed rule because, in the experience of other Federal
agencies, some collection sites have discarded any specimen of less
than 45 mL and conducted another collection to obtain a sufficient
amount of urine to fill both Bottles A and B. Should any Part 26
programs follow this practice, the efficiency of FFD programs would be
reduced and the burden on donors from being subject to testing would be
unnecessarily increased. The 30 mL quantity is sufficient to permit
retesting of the specimen in Bottle A, at the donor's discretion, and,
therefore, having 15 mL of urine available for Bottle B is unnecessary
to ensure donors' rights to retesting. The proposed rule would
incorporate these clarifications from the HHS Guidelines to ensure that
Part 26 programs do not adopt this inefficient and burdensome practice.
Proposed Sec. 26.113(b)(3) would retain the portion of current
Section 2.4(g)(20) in Appendix A to Part 26 that requires the donor to
observe the process of splitting the specimens and maintain visual
contact with the specimen bottles until they are sealed and prepared
for storage or shipping.
Proposed Sec. 26.113(c) would be added to establish priorities for
using the specimen that has been collected. The proposed paragraph
would permit the licensee testing facility to test aliquots of the
specimen at a licensee testing facility or to test for additional drugs
beyond those required under proposed Sec. 26.31(d)(1), but only if the
donor has provided a specimen of at least the predetermined quantity,
as discussed with respect to proposed Sec. 26.109 [Urine specimen
quantity]. As discussed with respect to proposed Sec. 26.113(b)(2),
the proposed rule would require the collector first to ensure that 30
mL of urine is available for Bottle A and 15 mL for Bottle B. If the
donor has provided more than 45 mL of urine and the additional amount
is sufficient to support testing at the licensee testing facility,
testing for additional drugs, or both, the proposed rule would permit
the remaining amount of urine, above the 45 mL required for Bottles A
and B, to be subject to such testing. However, if the donor has
provided only 45 mL of urine, the proposed rule would require that the
15 mL of urine that remains after 30 mL has been retained for Bottle A
must be used for Bottle B rather than to conduct testing at the
licensee testing facility or testing for additional drugs. The proposed
rule would establish the priority of using the 15 mL of urine for
Bottle B, rather than for testing at a licensee testing facility or
additional drugs, because the FFD program has established the
expectation among donors in this instance that the FFD program will
follow split specimen procedures and that Bottle B will be available
for retesting at the donor's request. Reserving the 15 mL of urine for
Bottle B would also be consistent with the principle that would be
established in the last sentences of proposed Sec. Sec. 26.135(b) and
26.165(a)(4) that control over testing of the specimen contained in
Bottle B would reside with the donor.
Section 26.115 Collecting a Urine Specimen Under Direct Observation
Proposed Sec. 26.115 [Collecting a urine specimen under direct
observation] would group together in one section the requirements of
the proposed rule that apply to collecting a urine specimen under
direct observation. This organizational change would be made because
requirements that address this topic are dispersed throughout the
current rule. The proposed section would also incorporate more detailed
procedures for collecting specimens under direct observation, based
upon related requirements from other relevant Federal rules and
guidelines. More detailed procedures are necessary because devices and
techniques to subvert the testing process have been developed since
Part 26 was first published that are difficult to detect in many
collection circumstances, including under direct observation, such as a
false penis or other realistic urine delivery device containing a
substitute urine specimen and heating element that may be used to
replicate urination. Therefore, the proposed changes would be made to
increase the likelihood of detecting such attempts to subvert the
testing process and, thereby, increase the effectiveness of directly
observed collections in assuring that a valid specimen is obtained from
the donor.
Proposed Sec. 26.115(a) would amend and combine current Section
2.4(f), 2.4(g)(17), and (g)(25) in Appendix A to Part 26, which
establish requirements for collecting a urine specimen under direct
observation. The proposed paragraph would assign responsibility for
approving a directly observed collection to the MRO or FFD program
manager, rather than a ``higher level supervisor'' of the collector in
current Section 2.4(b)(25) in Appendix A to Part 26. This proposed
change would ensure that the decision to conduct a directly observed
collection is made by an individual who is thoroughly knowledgeable of
the requirements of this part and the emphasis that the NRC places on
maintaining the individual privacy of donors. The proposed change would
also be consistent with revised requirements in the HHS Guidelines
related to who may authorize a directly observed collection.
The proposed rule would also list the circumstances that constitute
a reason to believe that a donor may dilute, substitute, adulterate, or
otherwise alter a specimen, and that would, therefore, warrant the
invasion of individual privacy associated with a directly observed
collection, as follows:
Proposed Sec. 26.115(a)(1) would amend current Section 2.4(f)(2)
in Appendix A to Part 26, which specifies that a directly observed
collection may be performed if the last urine specimen provided by
donor yielded specific gravity and creatinine concentration results
that are inconsistent with normal human urine. The proposed paragraph
would amend the current provision in several ways.
First, the proposed rule would eliminate the limitation in the
current paragraph that a specimen may be collected under direct
observation if ``the last urine specimen'' provided by the individual
yielded specific gravity and creatinine concentration results that are
inconsistent with normal human urine. The proposed rule would permit a
directly observed collection if the donor had presented a specimen with
characteristics that are inconsistent with normal human urine ``at this
or a previous collection.'' The proposed change would be necessary for
[[Page 50538]]
consistency with proposed Sec. 26.75(b), which would require that an
individual who has subverted or attempted to subvert any test conducted
under Part 26 must be subject to a permanent denial of authorization.
Because proposed Sec. 26.75(b) would require permanent denial of
authorization to a donor who has engaged in a subversion attempt,
individuals whose last specimen had characteristics that are
inconsistent with normal human urine would not be subject to further
testing under the rule. However, there may be instances in which a
licensee or other entity is aware that an individual has engaged in a
subversion attempt under a drug testing program that is not regulated
by the NRC. If the licensee or other entity is considering granting
authorization under Part 26 to the individual, then a directly observed
collection would be warranted to ensure that the donor did not have an
opportunity to tamper with the specimen and, therefore, that drug test
results would be accurate. The amended language of the proposed
provision would permit collecting a specimen under direct observation
in such circumstances.
Second, the proposed rule would update the current provision by
replacing the specific gravity and creatinine concentration values that
are included in the current paragraph with references to a urine
specimen that ``the HHS-certified laboratory reported as being
substituted, adulterated, or invalid to the MRO and the MRO reported to
the licensee or other entity that there is no adequate medical
explanation for the result.'' This proposed change would be made for
consistency with the addition of more detailed requirements for
validity testing throughout the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i). The cutoff concentrations and
specimen characteristics that would lead the HHS-laboratory to report a
specimen as substituted, adulterated, or invalid would be specified in
proposed Sec. 26.161 [Cutoff levels for validity testing].
Requirements for the MRO's review of the test results would be
specified in proposed Sec. 26.185 [Determining a fitness-for-duty
policy violation].
Proposed Sec. 26.115(a)(2) would combine and update current
Sections 2.4(f)(1) and 2.4(g)(14) in Appendix A to Part 26, which
establish that the presentation of a specimen that falls outside of the
required temperature range is sufficient grounds to conduct a directly
observed collection. The proposed paragraph would retain the
requirement in current Section 2.4 (f)(1) in Appendix A to Part 26,
which specifies that a directly observed collection may be conducted at
any time the specimen's temperature falls outside of the required
temperature range. However, the proposed paragraph would amend the
current requirement for the collector to take an oral measure of
temperature with a sterile thermometer to permit other means of
measuring the donor's body temperature, for the reasons discussed with
respect to proposed Sec. 26.111(a). The proposed rule would also
retain the current requirement that a directly observed collection may
be conducted if the specimen's temperature falls outside of the
required range and the donor declines to provide a measurement of body
temperature, in proposed Sec. 26.115(a)(2)(i). However, proposed Sec.
26.115(a)(2)(ii) would eliminate the current permission to conduct a
directly observed collection in those instances in which the donor's
body temperature does not equal or exceed that of the specimen. The
proposed rule would establish a range of acceptable variability between
the donor's measured temperature and the specimen's temperature of 1EC/
1.8EF. If the donor's temperature differs from the specified
temperature by more than the specified amount, a directly observed
collection would be permitted. This proposed change would be made for
consistency with the related provision in the HHS Guidelines and to
recognize that a specimen temperature that is either much higher or
lower than the donor's body temperature may indicate that the donor has
attempted to subvert the testing process.
Proposed Sec. 26.115(a)(3) would update current Section 2.4(f)(3)
in Appendix A to Part 26, which permits a directly observed collection
if a collector observes donor conduct that clearly and unequivocally
demonstrates an attempt by the donor to substitute the specimen. The
proposed rule would add references to attempts to dilute and adulterate
a specimen, in addition to substitution, as behaviors that demonstrate
a subversion attempt, consistent with the NRC's heightened concern for
ensuring specimen validity in the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i). As discussed with respect to
proposed Sec. 26.107(b), donor conduct that clearly and unequivocally
demonstrates an attempt to alter a specimen may include, but is not
limited to, possession of a urine specimen before the collection has
occurred; possession of a vial, or vials, filled with chemicals that
are subsequently determined to be urine or an adulterant; possession of
a heating element; or evidence that the coloring agent used by the
licensee or other entity in a source of standing water at the
collection site [see proposed Sec. 26.87(e)(1)] discolors the
specimen.
Proposed Sec. 26.115(a)(4) would update current Section 2.4(f)(4)
in Appendix A to Part 26, which permits directly observed collections
if a donor has previously been determined to have engaged in substance
abuse and the specimen is being collected as part of a rehabilitation
program and/or pre-access testing following a confirmed positive test
result. The proposed paragraph would update the current requirement by
adding a cross-reference to proposed Sec. 26.69 [Authorization with
potentially disqualifying fitness-for-duty information], which would
establish requirements for granting or maintaining the authorization of
an individual about whom potentially disqualifying FFD information has
been discovered or disclosed. Several provisions in proposed Sec.
26.69 would permit or require directly observed collections, including
proposed Sec. 26.69(b)(5), which would require specimens to be
collected under direct observation for pre-access drug testing of
individuals who have been subject to sanctions under the rule. For
organizational clarity, the proposed paragraph would replace the
current requirement with a cross-reference to proposed Sec. 26.69,
rather than repeat the applicable requirements in this section.
Proposed Sec. 26.115(b) would amend the requirement in current
Section 2.4(g)(25) in Appendix A to Part 26 that the collector must
obtain permission from a ``higher level supervisor'' before conducting
a directly observed collection, as discussed with respect to proposed
Sec. 26.115(a). The second sentence of the proposed paragraph would be
added to require that, once the decision has been made to conduct a
directly observed collection based on a reason to believe that the
donor may alter a specimen, the collection must occur as soon as
reasonably practical. Although the NRC is not aware of any occasions in
Part 26 programs in which a directly observed collection has been
unreasonably delayed, the proposed requirement would ensure that test
results from the directly observed collection provide information about
the presence or absence of drugs and drug metabolites in the donor's
urine. If a collection is delayed for a day or more, metabolism may
cause the concentration of drugs and drug metabolites in the donor's
urine, if any are present, to fall below the cutoff levels established
in this part or by the
[[Page 50539]]
FFD program and, therefore, not be detected by testing. Non-negative
test results from testing a specimen collected under direct observation
would provide evidence to support a conclusion that the individual had
attempted to subvert the testing process in order to mask drug abuse,
whereas negative test results may counter the reason to believe that
the individual had attempted to subvert the testing process. Therefore,
conducting the directly observed collection as soon as reasonably
practical would ensure that test results from the specimen provide
relevant and useful information. The proposed requirement would also be
consistent with the requirements of other relevant Federal rules and
guidelines.
Proposed Sec. 26.115(c) would be added to require the collector to
inform the donor of the reason(s) for the directly observed collection
so that the donor is aware of the nature of the concern that has
initiated a directly observed collection. This proposed requirement
would be added to the proposed rule for two reasons: (1) Knowing the
reason for a directly observed collection may increase a donor's
willingness to cooperate in the procedure in order to counter the
reason to believe that the donor has or may attempt to alter the
specimen, and (2) informing the donor of the reason for a directly
observed collection would meet Goal 7 of this rulemaking, which is to
protect donors' right to due process, by ensuring that the donor is
aware of the concern that has initiated the collection. The proposed
paragraph would also be consistent with the requirements of other
relevant Federal rules and guidelines.
Proposed Sec. 26.115(d) would be added to establish recordkeeping
requirements related to the directly observed collection. The proposed
paragraph would require the collector to record on the specimen's
custody-and-control form that the specimen was collected under direct
observation and the reason for the directly observed collection. The
proposed requirement is necessary to ensure that the HHS-certified
laboratory and the MRO have this information available when the
specimen is tested and the MRO conducts his or her review of the test
results, as would be required under proposed Sec. 26.185 [Determining
a fitness-for-duty policy violation]. This information would be
important, for example, in an MRO's decision to request the laboratory
to test a specimen at the LOD that appeared to have been diluted, as
permitted under proposed Sec. 26.185(g)(2), in order to compare the
results from testing the dilute specimen with those obtained from
testing the specimen that was collected under direct observation. Non-
negative test results from the dilute specimen and the presence of the
same drugs or drug metabolites in the specimen collected under direct
observation would provide clear evidence that the donor had diluted the
first specimen in an attempt to mask drug use. The proposed paragraph
would also be consistent with the requirements of other relevant
Federal rules and guidelines.
Proposed Sec. 26.115(e) would retain and combine the existing
requirements in Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25)
in Appendix A to Part 26, which require that the individual who
observes the specimen collection must be of the same gender as the
donor. Consistent with the current requirements, the proposed rule
would permit another individual of the same gender to serve as the
observer if a qualified urine collector of the same gender is not
available, as long as the observer receives the instructions specified
in proposed Sec. 26.115(f). The proposed rule would combine the
current requirements in the proposed paragraph for organizational
clarity.
Proposed Sec. 26.115(f) would be added to specify the procedures
that must be followed in conducting a directly observed collection. The
procedures in the proposed paragraph would be followed by either a
qualified collector or an individual of the same gender who may serve
as the observer. These more detailed procedures are necessary because
devices and techniques to subvert the testing process have been
developed since Part 26 was first published that can be used under
direct observation without detection. Therefore, the proposed changes
would be made to increase the likelihood of detecting such attempts to
subvert the testing process and, thereby, increase the effectiveness of
directly observed collections in assuring that a valid specimen is
obtained from the donor.
Proposed Sec. 26.115(f)(1) would be added to specify that the
observer must instruct the donor to adjust his or her clothing to
ensure that the area of the donor's body between the waist and knees is
exposed. This proposed requirement would be added to ensure that the
observer could detect the use of an anatomically correct urine delivery
device.
Proposed Sec. 26.115(f)(2) would be added to specify the action to
be observed during the collection. This proposed requirement would be
consistent with the requirements of other Federal agencies and is
intended to ensure that the urine specimen is obtained from the donor's
body.
Proposed Sec. 26.115(f)(3) would be added to prohibit an observer
who is not the collector from touching the specimen container. The
proposed provision would be consistent with the related requirements of
other Federal agencies and is intended to protect the observer from any
potential claims by a donor that the observer had altered the specimen.
Proposed Sec. 26.115(f)(4) would be added to require the collector
to record the observer's name on the custody-and-control form, if the
observer is not the collector. The proposed requirement would be
consistent with the related requirements of other Federal agencies and
is intended to ensure that the observer's identity is documented,
should future questions arise regarding the collection.
Proposed Sec. 26.115(g) would be added to clarify that a donor's
refusal to participate in the directly observed collection would
constitute a refusal to test and, therefore, would be considered to be
an act to subvert the testing process, under proposed Sec. 26.75(b).
Current Section 2.4(j) in Appendix A to Part 26 requires the collector
to inform the MRO, and the MRO to inform licensee management, if a
donor fails to cooperate with the specimen collection process,
including, but not limited, to a refusal to provide a complete
specimen, complete paperwork, or initial the specimen bottles. The
current requirement does not specifically mention that a refusal to
participate in a directly observed collection is also an instance of a
failure to cooperate. In addition, the current rule does not require
the licensee or other entity to impose sanctions on a donor for
refusing to be tested. Therefore, the proposed paragraph would both
clarify the NRC's original intent by stating that a refusal to
participate in a directly observed collection constitutes a refusal to
test and update the current requirement by adding a cross-reference to
the proposed sanction of permanent denial of authorization that would
be required in such circumstances under proposed Sec. 26.75(b).
Proposed Sec. 26.115(h) would be added to specify the actions that
a collector must take, if a directly observed collection was required,
but was not performed. The collector would inform the FFD program
manager or designee of the omission, who would ensure that a directly
observed collection is immediately performed. Although the
concentrations of any drugs, drug metabolites, or blood alcohol in the
donor's specimens may fall below the
[[Page 50540]]
cutoff levels that would be specified in this part or in the licensee's
or other entity's FFD policy if several days have elapsed since the
directly observed collection should have occurred, testing a specimen
collected several days later would increase the likelihood of detecting
any subsequent drug or alcohol use. In addition, the metabolites from
using some drugs, such as marijuana, linger in an individual's body.
Therefore, conducting a directly observed collection may result in
detecting these metabolites. However, because elapsed time may reduce
the concentrations of drugs, drug metabolites, or blood alcohol in the
donor's specimens, the proposed rule would require a directly observed
collection to be performed immediately. The proposed provision would
use the term, ``immediately,'' to indicate that the licensee or other
entity may be required to call in the donor and a collector to perform
the directly observed collection, if the donor and collectors are not
on site when the oversight is identified. This proposed requirement
would increase consistency with the related requirements of other
Federal agencies and is intended to provide instructions for correcting
an oversight, which are not addressed in the current rule.
Section 26.117 Preparing Urine Specimens for Storage and Shipping
A new Sec. 26.117 [Preparing urine specimens for storage and
shipping] would reorganize and present together in one section current
requirements for safeguarding specimens and preparing them for transfer
from the collection site to the licensee's testing facility or the HHS-
certified laboratory for testing. This organizational change would be
made because requirements that address these topics are dispersed
throughout the current rule whereas grouping them together in a single
section would make them easier to locate within the proposed rule.
Proposed Sec. 26.117(a) would amend current Section 2.4(g)(20) in
Appendix A to Part 26, which requires the donor and collector to
maintain visual contact with specimens until they are sealed and
labeled. The proposed paragraph would eliminate reference to blood
specimens because donors would no longer be permitted to volunteer to
provide a blood specimen for alcohol testing under the proposed rule,
as discussed with respect to proposed Sec. 26.83(a). The proposed
paragraph would also amend the requirements in the second sentence of
the current provision. Procedural requirements for observing the
splitting of a specimen and sealing the split specimen bottles would be
moved to proposed Sec. 26.113 [Splitting the urine specimen] for
organizational clarity. However, the proposed paragraph would broaden
the current requirement, which addresses only split specimens, to
require the donor to observe the transfer of any specimen or aliquot
that the collector transfers to a second container and the sealing of
the container(s). This proposed requirement would be necessary because
some FFD programs who operate licensee testing facilities may transfer
an aliquot of the urine specimen to a second container for initial
testing at the licensee testing facility, while preserving the primary
specimen in the first or another container. The proposed rule would
require the donor to observe these actions in order to ensure that the
specimen or aliquot(s) that are transferred belong to the donor and
that the identity and integrity of the specimen are maintained.
Proposed Sec. 26.117(b) would retain current Section 2.4(g)(21) in
Appendix A to Part 26, which requires the donor and collector to remain
present while the procedures for sealing and preparing the specimen
(and aliquots, if applicable) for transfer are performed.
Proposed Sec. 26.117(c) would retain the meaning of current
Section 2.4(g)(22) in Appendix A to Part 26, which establishes
requirements for labeling and sealing the specimen(s), but split the
current requirement into several sentences for increased clarity in the
language of the provision.
For organizational clarity, proposed Sec. 26.117(d) would combine
current Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26,
which require the donor to certify that the specimen was collected from
him or her. However, the proposed rule would delete current Section
2.4(g)(23)(ii), which requires the donor to have an opportunity to list
on the custody-and-control form any medications he or she has taken
within the past 30 days, for the reasons discussed with respect to
proposed Sec. 26.89(b)(3).
The proposed rule would delete current Section 2.4(g)(24) in
Appendix A to Part 26, which requires the collector to enter into the
permanent record book all information identifying the specimen. This
requirement would be eliminated because the proposed rule would no
longer require collection sites to maintain a permanent record book,
consistent with the elimination of the requirement to maintain a
permanent record book in the HHS Guidelines. Collection sites would be
permitted to use other means of tracking specimen identity, including,
but not limited to bar coding.
Proposed Sec. 26.117(e) would amend current Section 2.4(g)(26) in
Appendix A to Part 26, which requires the collector to complete the
chain-of-custody forms for both the aliquot and the split sample and
certify proper completion of the collection. The proposed rule would
eliminate reference to the aliquot and split sample in the current
paragraph to clarify the intent of this requirement, which is that the
collector must complete the appropriate chain-of-custody forms for all
of the sealed specimen and aliquot containers, not simply those
resulting from a split specimen procedure. For example, if an FFD
program follows split specimen procedures and conducts initial testing
at a licensee testing facility, the donor's urine specimen may be
divided into Bottle A, Bottle B, and another container that would be
used for tests at the licensee testing facility. The proposed paragraph
would retain the current requirement for the collector to certify
proper completion of the collection.
Proposed Sec. 26.117(f) would amend current Section 2.4(g)(27) in
Appendix A to Part 26, which states that the specimens and chain-of-
custody forms are now ready for transfer and must be appropriately
safeguarded if they are not immediately prepared for shipment. The
proposed rule would replace the first sentence of the current
provision, which states that the specimens and forms are ready for
transfer, with a requirement for the collector to package the specimens
and forms for transfer to the HHS-certified laboratory or licensee
testing facility. This proposed change would improve the clarity in the
rule's language, because it is necessary for the collector to package
the specimens and chain-of-custody forms for transfer before they are
ready to be transferred. The proposed paragraph would retain the second
sentence of the current provision.
Proposed Sec. 26.117(g) would retain current Section 2.4(g)(28) in
Appendix A to Part 26, which requires the collector to maintain control
of the specimens and custody documents and ensure they are secure, if
he or she must leave the workstation or collection site for any reason.
The proposed paragraph would make minor editorial changes to some of
the terminology used in the current paragraph for consistency with the
terminology used throughout the proposed rule, as discussed with
respect to proposed Sec. 26.5 [Definitions], but retain the intended
meaning of the current requirements.
[[Page 50541]]
Proposed Sec. 26.117(h) would retain the requirements in current
Section 2.4(c)(2) in Appendix A to Part 26 related to maintaining
specimen security until the specimens are sent to the licensee testing
facility or the HHS-certified laboratory for testing from the
collection site. The current paragraph would be moved to this section
of the proposed rule for organizational clarity because this is the
point in the specimen collection procedures at which requirements for
maintaining specimen security would apply. The portion of the current
paragraph that applies to situations in which it is impractical to
maintain continuous physical security of a collection site would be
moved to proposed Sec. 26.87(f)(5) for organizational clarity because
proposed Sec. 26.87(f) addresses those circumstances.
Proposed Sec. 26.117(i) would update the specimen packaging
requirements in current Section 2.4(i) in Appendix A to Part 26 by
replacing the current paragraph with the related provision from the HHS
Guidelines. The first sentence of the current paragraph, which directs
collection site personnel to arrange to transfer the specimens to the
licensee testing facility or HHS-certified laboratory, would be moved
to proposed Sec. 26.117(j) for organizational clarity. Proposed Sec.
26.117(j) would address transfer and storage requirements, while
proposed Sec. 26.117(i) would address packaging requirements. The
proposed paragraph would also eliminate the initial phrases in the
second sentence of the current paragraph, which list the conditions
under which specimens will be transferred offsite (e.g., shipping
specimens that test as ``presumptive positive'' on initial testing at
the licensee testing facility, special processing of suspect
specimens), because they would be redundant with other portions of the
proposed rule. Proposed requirements related to transferring specimens
from a licensee testing facility to an HHS-certified laboratory for
further testing would be moved to proposed Sec. 26.129(g) in Subpart F
[Licensee Testing Facilities] for organizational clarity. The proposed
rule would also eliminate the third sentence of the current paragraph,
which requires the collector to sign and date the tape used to seal the
container. This requirement would be eliminated because licensees and
other entities now rely upon courier services to transfer specimens who
offer other means of tracking the date that a container of specimens is
shipped and the sender that program experience has shown are equally
effective. The proposed paragraph would retain the intended meaning of
the current requirements for the collector to place the specimens in a
second container that minimizes the possibility of damage during
shipment and seal them so that tampering will be detected. At the
request of stakeholders during the public meetings discussed in Section
V, the proposed rule would add shipping bags to the current set of
examples of acceptable shipping containers that protect the specimens
from damage. Also at the request of stakeholders, the proposed rule
would delete the last sentence of the current paragraph, which requires
the collector to ensure that chain-of-custody documents are attached to
the container that is used to ship the specimens to the licensee
testing facility or laboratory. The stakeholders requested this change
because their practice is to seal the specimens' custody-and-control
documentation inside the shipping container to ensure that it cannot be
altered. The NRC endorses this practice as providing greater protection
for donors and, therefore, proposes this change.
Proposed Sec. 26.117(j) would amend and combine the first sentence
of current Section 2.4(i) in Appendix A to Part 26 with the
requirements applicable to short-term storage of specimens at
collection sites in current Section 2.7(c) in Appendix A to Part 26.
The first sentence of current Section 2.4(i) in Appendix A to Part 26
would be moved to the proposed paragraph for the reasons discussed with
respect to proposed Sec. 26.117(i). Under the proposed paragraph,
short-term refrigerated storage of specimens within 6 hours of
collection would no longer be required for all specimens, as a result
of advances in testing technologies. However, the proposed rule would
continue to require licensees and other entities to protect specimens
from any conditions that could cause specimen degradation. Collection
site personnel would be required to refrigerate specimens that are not
transferred or shipped to the licensee testing facility or the HHS-
certified laboratory within 24 hours of collection. The proposed rule
would also require that any specimens that may have been substituted or
adulterated must be refrigerated as soon as they are collected, because
some adulterants may interfere with drug testing results unless the
specimen is refrigerated. The proposed rule would establish a time-
limit of 2 business days for receipt of specimens at the licensee
testing facility or HHS-certified laboratory, after shipment from the
collection site, to further protect against potential specimen
degradation.
Proposed Sec. 26.117(k) would amend the portions of current
Section 2.4(h) in Appendix A to Part 26 that require every individual
in the chain of custody to be identified on a specimen's custody-and-
control form. The proposed rule would not require couriers to meet the
requirements in current Section 2.4(h), which state that each time a
specimen is handled or transferred, the date and purpose of the
transfer must be documented on the chain-of-custody form and every
individual in the chain of custody must be identified. Couriers would
not be required to meet these requirements because custody-and-control
forms for individual specimens would be packaged inside the shipping
container where they are inaccessible to couriers so that it is
impractical to expect them to sign them when handling the specimen
shipping containers. The proposed paragraph would codify licensees' and
other entities' current practices of relying upon courier services'
normal package tracking systems to maintain accountability for specimen
shipping containers, which is consistent with the HHS Guidelines and
standard forensic practices. The proposed rule would also eliminate the
current requirement, contained in the last sentence of Section 2.4(h)
in Appendix A to Part 26, to minimize the number of persons handling
specimens because this requirement cannot be enforced.
Section 26.119 Determining ``Shy'' Bladder
A new Sec. 26.119 [Determining ``shy'' bladder] would be adapted
from the DOT Procedures at 49 CFR 40.193 to specify procedures for
determining whether a donor who does not provide a urine specimen of 30
mL within the 3 hours that would be permitted for a specimen collection
is refusing to test or has a medical reason for being unable to provide
the required 30 mL specimen. The proposed section would be respond to
stakeholder requests during the public meetings discussed in Section V.
The stakeholders reported that some donors have had difficulty
providing the 60 mL of urine that was required in current Section
2.4(g)(11) for medical reasons, but the current rule does not establish
procedures for handling such circumstances. As a result, some FFD
programs have adopted the DOT ``shy bladder'' procedures, but the
stakeholders preferred that the proposed rule incorporate the
requirements to (1) clarify that the NRC accepts the procedures; (2)
inform donors of the procedures that they are required to
[[Page 50542]]
follow if they have medical reasons for being unable to provide a
sufficient quantity of urine for testing; (3) enhance consistency among
Part 26 programs; and (4) enhance the consistency of Part 26 procedures
with the procedures that collectors must follow when conducting tests
under DOT requirements. The NRC expects that fewer donors will be
subject to ``shy bladder'' problems under the proposed rule because
proposed Sec. 26.109 [Urine specimen quantity] would reduce the
minimum quantity of urine required from 60 mL in the current rule to 30
mL. However, because some donors' medical problems may also interfere
with their ability to provide 30 mL of urine, the proposed rule would
incorporate the DOT procedures. In general, the purpose of these
proposed procedures is to protect the due process rights of individuals
who are subject to Part 26. That is, the proposed section would
establish procedures for ensuring that there is a legitimate medical
reason that a donor was or is unable to provide a urine specimen of the
required quantity so that the licensee or other entity has a medical
basis for not imposing sanctions on the individual. In addition, the
MRO would be authorized to devise alternative methods of drug testing,
if it appears that the donor's medical problem would prevent him or her
from being able to provide sufficient urine for drug testing in future
tests.
Proposed Sec. 26.119(a) would be added to require that a licensed
physician, who has appropriate expertise in the medical issues raised
by the donor's failure to provide a sufficient specimen, must evaluate
a donor who was unable to provide a urine specimen of at least 30 mL.
The MRO would be permitted to perform the evaluation, if the MRO
possesses the appropriate expertise. If not, the MRO would be required
to review the qualifications of the physician and agree to the
selection of that physician. These proposed requirements for the
physician who performs the evaluation to be qualified in the relevant
medical issues are necessary to ensure that the results of the
evaluation would be valid.
The proposed paragraph would also require that the evaluation must
be completed within 5 days of the unsuccessful collection. The 5-day
time limit would be established on the basis of a trade-off between the
necessity to provide the donor with sufficient time to locate a
qualified physician, obtain an appointment, and for the physician to
complete the evaluation (i.e., the donor's right to due process) and
the public's interest in a rapid determination of whether the donor had
attempted to subvert the testing process by refusing to provide a
sufficient specimen. The DOT's experience has indicated that 5 days is
sufficient to complete the evaluation.
Proposed Sec. 26.119(b) would be added to specify the information
that the MRO must provide to the physician who is selected to perform
the evaluation if the MRO does not perform it. Proposed Sec.
26.119(b)(1) and (b)(2) would require the MRO to inform the physician
that the donor was required to take a drug test under Part 26 but was
unable to provide a sufficient quantity of urine for testing, and
explain the potential consequences to the donor for a refusal to test.
These proposed requirements would ensure that the evaluating physician
understands the context in which he or she is being asked to perform
the evaluation. Proposed Sec. 26.119(b)(3) would also require the MRO
to inform the physician that he or she must agree to follow the
procedures specified in proposed Sec. 26.119(c)-(f) if he or she
performs the evaluation. This proposed requirement would ensure that
the physician understands and consents to follow the proposed
procedures specified in this section.
Proposed Sec. 26.119(c) would be added to describe the conclusions
that the physician must provide to the MRO following the evaluation.
Under proposed Sec. 26.119(c)(1), the physician may determine that a
medical condition has, or with a high degree of probability could have,
precluded the donor from providing the required quantity of urine. Or,
under proposed Sec. 26.119(c)(2), the physician may determine that
there is an inadequate basis for determining that a medical condition
has, or with a high degree of probability could have, precluded the
donor from providing a sufficient quantity of urine. The proposed rule
would limit the physician's conclusions to one of these two
alternatives in order to ensure that the results of the evaluation are
relevant to and useful for determining whether sanctions must be
imposed on the donor for a refusal to test.
Proposed Sec. 26.119(d) would be added to define the physical and
psychological conditions that would constitute a medical condition that
could have precluded the donor from providing a 30 mL specimen and
provide examples of conditions that would not constitute a legitimate
medical condition. Legitimate medical conditions would include an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a medically documented pre-existing psychological
disorder that precluded the donor from providing a 30 mL specimen.
Unsupported assertions of ``situational anxiety'' or dehydration would
be examples of conditions that could not be considered legitimate
medical conditions. The proposed rule would add this paragraph to
provide necessary guidance to the evaluating physician.
Proposed Sec. 26.119(e) would be added to require the evaluating
physician to provide a written statement of his or her findings and
conclusion from the evaluation. By implication, if the MRO performs the
evaluation, the MRO would provide this written statement. The written
statement would be necessary to communicate the results of the
evaluation and create a record of it, should any question arise later
with respect to the determination.
The proposed paragraph would also require that the physician must
provide only the information that is necessary to support the
physician's conclusion. This proposed requirement would be added to
protect the donor's privacy by ensuring that the only medical
information documented is information that is necessary to support the
determination.
Proposed Sec. 26.119(f) would be added to require the physician to
inform the MRO, in the written statement, whether any medical condition
that may be identified would also preclude the donor from providing
specimens of 30 mL or more in future collections. This information
would be necessary for the MRO to determine whether alternative methods
of drug testing must be implemented for the donor, as required under
proposed Sec. 26.119(g)(3).
Proposed Sec. 26.119(g) would be added to prescribe the actions to
be taken by the MRO based on the results of the evaluation, as follows:
Proposed Sec. 26.119(g)(1) would require the MRO to determine that
the donor did not violate the FFD policy, if the physician concluded
that a medical condition could account for the insufficient specimen
and the MRO concurred with that conclusion. In this instance, the
licensee or other entity would not impose sanctions on the donor
because the donor had not violated the FFD policy by refusing to test.
Proposed Sec. 26.119(g)(2) would require the MRO to determine that
the donor had refused to be tested by failing to provide a sufficient
specimen, if the physician concluded that a medical condition could not
account for the insufficient specimen. In this instance, the licensee
or other entity would impose the sanction of a permanent denial of
authorization for an attempt to subvert the testing process, as
required under proposed Sec. 26.75(b).
[[Page 50543]]
Proposed Sec. 26.119(g)(3) would require the MRO to devise an
alternative method of collecting specimens for drug testing, if the
donor's medical condition would, over the long-term, consistently
prevent the donor from providing urine specimens of 30 mL or more. For
example, the proposed provision would permit the MRO to direct the
collection and testing of alternate specimens, including, but not
limited to, hair, or other bodily fluids, if, in the MRO's professional
judgment, the collection and analysis of these alternate specimens
would be scientifically defensible and forensically sound. The proposed
paragraph would grant flexibility to the MRO in exercising his or her
professional judgment in determining an alternative method of
conducting drug testing, rather than establish detailed requirements
which may not appropriately address the range of possible medical
conditions that could arise.
Subpart F--Licensee Testing Facilities
Section 26.121 Purpose
A new Sec. 26.121 [Purpose] would be added to provide an overview
of the contents of the proposed subpart, consistent with Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Section 26.123 Testing Facility Capabilities
Proposed Sec. 26.123 [Testing facility capabilities] would amend
the second sentence of current Section 2.7(l)(2) in Appendix A to Part
26 as it relates to the capabilities of licensee testing facilities.
The proposed paragraph would retain the current requirement for
licensee testing facilities to be capable of performing initial tests
for each drug and drug metabolite for which testing is conducted by the
FFD program and would add a requirement for licensee testing facilities
to have the capability to perform either validity screening tests,
initial validity tests, or both. The first sentence of current Section
2.7(l)(2), which establishes requirements for the capabilities of HHS-
certified laboratories would be moved to proposed Subpart G
[Laboratories Certified by the Department of Health and Human
Services]. The last sentence of the current paragraph, which permits
the testing of breath specimens for alcohol at the collection site,
would be deleted here because the proposed rule would address alcohol
testing in Subpart E [Collecting Specimens for Testing]. These proposed
organizational changes to the current paragraph would be made to meet
Goal 6 of this rulemaking, which is to improve organizational clarity
in the rule.
Section 26.125 Licensee Testing Facility Personnel
Proposed Sec. 26.125 [Licensee testing facility personnel] would
amend current Section 2.6 in Appendix A to Part 26, as follows:
Proposed Sec. 26.125(a) would retain current Section 2.6(a) in
Appendix A to Part 26, which requires each licensee testing facility to
have one or more individuals who are responsible for the day-to-day
operations of the facility and establishes requirements for those
individuals' qualifications. The proposed paragraph would make minor
changes in the language of this paragraph, which would be consistent
with amended language in the related portion of the HHS Guidelines.
Proposed Sec. 26.125(b) would amend current Section 2.6(b) in
Appendix A to Part 26, which requires laboratory technicians and
nontechnical staff to have the necessary training and skills for the
tasks assigned to them. The proposed rule would retain the first
sentence of the current provision, but would add another. The proposed
rule would require laboratory technicians who perform urine specimen
testing to demonstrate proficiency in operating the testing instruments
and devices used at the licensee testing facility. This proficiency
requirement would be added to ensure that technicians are capable of
correctly using the instruments and devices that the licensee testing
facility has selected for validity and drug testing. This proposed
change is necessary for several reasons. First, the proposed rule would
add new requirements for licensee testing facilities to conduct
validity testing, and the instruments and devices that the technicians
would be using are likely to differ from those previously used at
licensee testing facilities. Therefore, additional training and
proficiency testing would be required to ensure that validity testing
would be conducted properly. Second, proposed rule permits licensees
and other entities to rely on drug test results from testing that was
performed by another Part 26 program to a greater extent than the
current rule. Therefore, it is necessary to ensure that all drug
testing performed under Part 26, including tests performed at licensee
testing facilities, meets minimum standards. The proposed requirement
for technicians to demonstrate proficiency, then, would contribute to
meeting this goal. Third, the experience of other Federal agencies has
shown that requirements for technicians to demonstrate proficiency
assist in any litigation that may occur with respect to urine test
results.
Proposed Sec. 26.125(c) would amend current Section 2.6(c) in
Appendix A to Part 26, which establishes recordkeeping requirements for
the personnel files of licensee testing facility personnel. The current
requirement for records of tests for color blindness would be
eliminated here, consistent with a similar change to the HHS
Guidelines. Tests for color blindness would no longer be necessary
because current testing technologies provide means other than color for
reading test results.
Section 26.127 Procedures
Proposed Sec. 26.127 [Procedures] would combine, reorganize, and
amend requirements for procedures that are interspersed throughout
Appendix A to Part 26, including requirements in current Sections 2.2
and 2.7. These organizational changes would be made to improve clarity
in the organization of the rule by grouping procedural requirements for
licensee testing facilities in one section.
Proposed Sec. 26.127(a) would make minor editorial changes to the
first sentence of current Section 2.2 in Appendix A to Part 26, which
requires licensee testing facilities and HHS-certified laboratories to
have detailed procedures for conducting testing. The proposed rule
would delete the current reference to blood samples because donors
would no longer have the option to request blood testing for alcohol,
as discussed with respect to proposed Sec. 26.83(a). Reference to HHS-
certified laboratories would be moved to proposed Sec. 26.157(a) in
Subpart G [Laboratories Certified by the Department of Health and Human
Services] to improve the organizational clarity of the rule. The
proposed rule would also delete the current reference to procedures for
specimen collections, because procedural requirements for specimen
collections would be relocated to proposed Subpart E [Collecting
Specimens for Testing].
Proposed Sec. 26.127(b) would combine and amend portions of the
requirements in the first sentence of current Sections 2.4(d) and
2.7(a)(2) in Appendix A to Part 26 related to the content and
implementation of specimen chain-of-custody procedures. The proposed
paragraph would retain the portions of the current paragraphs that
require licensee testing facilities to develop, implement, and maintain
written chain-of-custody procedures to maintain control and
accountability of specimens from receipt through completion of
[[Page 50544]]
testing and reporting of results, during storage and shipping to the
HHS-certified laboratory, and continuing until final disposition of the
specimens. The current requirements related to HHS-certified
laboratories would be moved to proposed Sec. 26.157(b) in Subpart G
[Laboratories Certified by the Department of Health and Human Services]
to improve organizational clarity. The proposed rule would also remove
references to custody-and-control procedures for blood specimens
because donors would no longer have the option to request blood testing
for alcohol, as discussed with respect to proposed Sec. 26.83(a).
Proposed Sec. 26.127(c) would retain the portions of current
Section 2.7(o)(1) in Appendix A to Part 26 that address the required
content of procedures for licensee testing facilities and amend the
current requirements. The proposed paragraph would retain the portions
of the current provision that require licensee testing facilities to
develop and maintain procedures to specify all of the elements of the
testing process, including, but not limited to, the principles of each
test and the preparation of reagents, standards, and controls. The
proposed paragraph would present the required topics of the procedures
in a list format in proposed Sec. 26.127(c)(1)-(c)(12) to clarify that
each topic stands on its own, and to improve clarity in the
organization of the rule.
Proposed Sec. 26.127(c) would also amend current Section 2.7(o)(1)
in Appendix A to Part 26 in several ways. First, the proposed paragraph
would eliminate the current requirement for the procedures to be
maintained in a laboratory manual as unnecessarily restrictive.
Licensee testing facilities would be permitted to use other means to
maintain their procedures. Second, the proposed paragraph would add a
requirement for the development, implementation, and maintenance of
written standard operating procedures for validity testing instruments
and devices, consistent with the addition of requirements to conduct
validity testing throughout the proposed rule. Third, two portions of
the current provision would be moved to other subparts of the proposed
rule that address related topics to improve clarity in the organization
and language of the rule, as follows: The last two sentences of current
Section 2.7(o)(1) in Appendix A to Part 26, which address requirements
for retaining copies of superceded procedures, would be relocated to
Sec. 26.215(a) of Subpart J [Recordkeeping and Reporting Requirements]
of the proposed rule. Procedural requirements for HHS-certified
laboratories would be moved to Sec. 26.157(b) in proposed Subpart G
[Laboratories Certified by the Department of Health and Human
Services].
Proposed Sec. 26.127(d) would amend current Section 2.7(o)(3)(iii)
in Appendix A to Part 26, which requires procedures for the setup and
normal operation of testing instruments, a schedule for checking
critical operating characteristics for all instruments, tolerance
limits for acceptable function checks, and instructions for major
troubleshooting and repair. The proposed paragraph would extend the
current requirements to non-instrumented devices (such as some validity
screening devices), if the licensee testing facility uses such devices,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule. The proposed rule would also make
three organizational changes to the current provision. The proposed
paragraph would present the required topics of the procedures in a list
format in proposed Sec. 26.127(d)(1)-(d)(3) to clarify that each topic
stands on its own. The current requirement to maintain records of
preventative maintenance would be relocated to Sec. 26.215(b)(10) in
Subpart J [Recordkeeping and Reporting Requirements] of the proposed
rule. And, the current requirements that apply to HHS-certified
laboratories would be moved to Sec. 26.157(d) in proposed Subpart G
[Laboratories Certified by the Department of Health and Human
Services]. These proposed changes would made to improve clarity in the
organization of the rule.
Proposed Sec. 26.127(e) would reorganize and amend current Section
2.7(o)(4) in Appendix A to Part 26, which requires documented
corrective actions if systems are out of acceptable limits or errors
are detected. The proposed paragraph would extend the current
requirement to non-instrumented validity screening devices, if the
licensee testing facility uses such devices, consistent with the
addition of requirements to conduct validity testing throughout the
proposed rule. The requirements in the current paragraph that apply to
HHS-certified laboratories would be moved to Sec. 26.157(e) in
proposed Subpart G [Laboratories Certified by the Department of Health
and Human Services] for organizational clarity.
Section 26.129 Assuring Specimen Security, Chain of Custody, and
Preservation
Proposed Sec. 26.129 [Assuring specimen security, chain of
custody, and preservation] would be added to group together in one
section the requirements of the proposed rule that apply to licensee
testing facilities with respect to the safeguarding of specimen
identity, integrity, and security. This proposed organizational change
would be made because requirements that address these topics are
dispersed throughout the current rule whereas grouping them together in
a single section would make them easier to locate within the proposed
rule.
Proposed Sec. 26.129(a) would retain the first four sentences of
current Section 2.7(a)(1) in Appendix A to Part 26, which require
licensee testing facilities to be secure and accessible only to
authorized personnel. These requirements as they apply to HHS-certified
laboratories would be moved to proposed Sec. 26.159(a). The last
sentence of the current paragraph, which establishes recordkeeping
requirements, would be moved to Sec. 26.215(b)(13) in proposed Subpart
J [Recordkeeping and Reporting Requirements]. The proposed changes
would be made for organizational clarity.
Proposed Sec. 26.129(b) would amend current Section 2.7(b)(1) in
Appendix A to Part 26, which establishes requirements for receiving
specimens at the licensee testing facility and assuring their integrity
and identity. The proposed rule would move the current requirements
related to HHS-certified laboratories to Sec. 26.159(b) in proposed
Subpart G [Laboratories Certified by the Department of Health and Human
Services] for organizational clarity. Several requirements would also
be added to the proposed paragraph, as follows:
The proposed paragraph would add requirements for licensee or other
entity management personnel to investigate any indications of specimen
tampering and take corrective actions if tampering is confirmed. The
proposed rule would add these requirements because some licensees have
not investigated or taken corrective actions in response to indications
of tampering with specimens under the current rule. The appropriate
corrective actions that management personnel would take would depend
upon the nature of the tampering identified as a result of the
investigation. For example, if the investigation indicated that the
tampering was an attempt to subvert the testing process and the persons
involved were identified, management personnel would impose the
sanctions in proposed Sec. 26.75(b) for a subversion attempt.
Management personnel would also be required to correct any systematic
weaknesses in specimen custody-and-control procedures that may be
[[Page 50545]]
identified in the investigation, such as inadequate safeguarding of
specimen shipping containers.
The proposed paragraph would also add a requirement for licensee
testing facility personnel to attempt to resolve any discrepancies in
the information on specimen bottles or on the accompanying custody-and-
control forms to ensure the identity and integrity of specimens and
prevent specimens from being unnecessarily rejected for testing by the
HHS-certified laboratory (if the specimen must be subject to additional
testing) when flaws can be corrected. For example, if the collector's
signature is missing on the custody-and-control form, licensee testing
facility personnel would work with collection site personnel to attempt
to identify the collector and obtain the collector's signature on the
form if possible. This proposed requirement would reduce the potential
burden on donors who may otherwise be required to submit additional
specimens to replace those for which the chain-of-custody could not be
confirmed. The proposed requirements would also improve the efficiency
of FFD programs by avoiding the need to conduct additional specimen
collections when discrepancies can be corrected. The proposed provision
would also meet Goal 1 of this rulemaking, which is to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
The proposed paragraph would also add a prohibition on testing of
any specimens if the licensee or other entity has reason to believe
that the specimens that were subject to tampering had been altered in
such a manner as to affect specimen identity and integrity. In these
circumstances, the MRO would cancel testing of the specimens or any
test results from those specimens, and require the licensee or other
entity to retest the donors who had submitted them. Although the NRC is
not aware of any instances in which these circumstances have arisen in
Part 26 programs, the experience of other Federal agencies indicates
such tampering is possible. Therefore, this requirement would be
necessary to ensure that individuals are not subject to sanctions for a
non-negative test result from a specimen that may not have been theirs.
The proposed change would be made to meet Goal 7 of this rulemaking,
which is to protect the due process rights of individuals who are
subject to Part 26. The additional provision would also be consistent
with the requirements of other Federal agencies.
Proposed Sec. 26.129(c) would amend current Section 2.7(b)(2) in
Appendix A to Part 26, which establishes requirements for chain-of-
custody procedures for specimens and aliquots at licensee testing
facilities. The proposed rule would move the requirements in the
current paragraph that are related to HHS-certified laboratories to
proposed Subpart G [Laboratories Certified by the Department of Health
and Human Services] to improve organizational clarity. In addition, the
proposed paragraph would add a reference to specimen validity testing
for consistency with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i).
The proposed paragraph would incorporate two additional changes to
the current provision at the request of stakeholders at the public
meetings discussed in Section V. The stakeholders requested that the
proposed rule permit licensee testing facilities to use methods other
than a custody-and-control form to maintain the chain of custody for
aliquots of a specimen that are tested at the licensee testing
facility. The proposed change would be incorporated because methods
other than a custody-and-control form, such as the use of bar coding,
have been shown to be equally effective at tracking the chain of
custody for an aliquot at licensee testing facilities. Continuing to
permit such flexibility would be consistent with Goal 5 of this
rulemaking, which is to improve Part 26 by eliminating or modifying
unnecessary requirements.
The stakeholders also requested that the proposed paragraph specify
the conditions under which specimens and aliquots may be discarded
because the current rule does not address discarding of negative
specimens. Therefore, the proposed rule would permit licensee testing
facilities to discard specimens and aliquots as soon as practical after
validity screening or initial validity tests have demonstrated that the
specimen appears to be valid and initial test results for drugs and
drug metabolites are negative. The proposed clarification would codify
current licensee practices. This permission would have no impact on
donors' rights under the rule, because donors are not at risk of
management actions or sanctions as a result of negative test results
and, therefore, would not need the licensee testing facility to retain
the specimen for additional testing for review or litigation purposes.
The proposed change would be made to meet Goal 6 of this rulemaking,
which is to improve clarity in the language of the rule.
Proposed Sec. 26.129(d) would update current Section 2.7(a)(2) in
Appendix A to Part 26, which requires licensee testing facility
personnel to maintain and document the chain of custody for specimens
and aliquots. The proposed paragraph would incorporate the simpler
language of the related provision from the HHS Guidelines while
retaining the intent of the current paragraph. The proposed rule would
relocate the requirements in the current paragraph that are related to
HHS-certified laboratories to Sec. 26.159(d) and (e) in proposed
Subpart G [Laboratories Certified by the Department of Health and Human
Services] to improve organizational clarity.
Proposed Sec. 26.129(e) would amend the first sentence of current
Section 2.7(d) in Appendix A to Part 26, which requires specimens that
test as ``presumptive positive'' at the licensee testing facility to be
shipped to the HHS-certified laboratory for further testing. The
proposed rule would replace the term, ``presumptive positive,'' with
the term, ``non-negative,'' in order to address validity testing
results, consistent with the addition of requirements to conduct
validity testing throughout the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i). For organizational clarity,
the requirements in current Section 2.7(d) in Appendix A to Part 26
that relate to quality control procedures for testing at licensee
testing facilities and HHS-certified laboratories would be moved to
proposed Sec. Sec. 26.137 [Quality assurance and quality control] and
26.167 [Quality assurance and quality control], respectively.
Proposed Sec. 26.129(f) would clarify and revise current Section
2.7(c) in Appendix A to Part 26, as it relates to refrigerating urine
specimens to protect them from degradation. For organizational clarity,
the proposed rule would move the current requirements that apply to
HHS-certified laboratories to proposed Sec. 26.159(h) in Subpart G
[Laboratories Certified by the Department of Health and Human
Services]. The proposed paragraph would restate portions of the current
provision and add a performance standard regarding ``appropriate and
prudent actions'' to minimize specimen degradation. For the reasons
discussed with respect to proposed Sec. 26.117(j), the proposed rule
would no longer require all specimens to be refrigerated within 6 hours
after collection, but would add a requirement that any specimen that
has not been tested within 24 hours of receipt at the licensee testing
facility
[[Page 50546]]
must be refrigerated. The proposed paragraph would continue to require
the licensee or other entity to refrigerate any specimen (and the
associated Bottle B for that specimen, if the FFD program follows split
specimen procedures) that yields non-negative results from initial drug
testing at the licensee testing facility. The proposed rule would also
add a requirement for refrigerating any specimen (and the associated
Bottle B) that yields non-negative results from validity screening or
initial validity testing at the licensee testing facility.
Refrigerating these specimens would be necessary because some
adulterants have been shown to interfere with drug test results more
rapidly if the specimen remains at room temperature.
The proposed rule would eliminate as unnecessary the last sentence
of the current paragraph, which requires licensee testing facilities to
ensure that emergency power equipment is available to maintain the
specimens cooled in the event of a power failure. With improvements in
the courier services available to licensee testing facilities since
Part 26 was first published, licensee testing facilities are typically
able to ship specimens to the HHS-certified laboratory on the same day
that specimens are tested. Further, program experience since the rule
was implemented indicates that the periods of time that licensee
testing facilities are without off-site power are typically limited to
a few hours at most, which would not be long enough for specimen
degradation to occur. Therefore, the proposed change would be made to
meet Goal 5 of this rulemaking, which is to improve Part 26 by
eliminating or modifying unnecessary requirements.
The proposed rule would also update the terminology used in the
current paragraph to be consistent with the new terminology adopted
throughout the proposed rule for referring to split specimens.
Therefore, in the proposed paragraph, the licensee testing facility
would continue to be responsible for protecting from degradation the
primary specimen (Bottle A) and the specimen in Bottle B of a split
specimen, if the FFD program follows split specimen procedures. The
licensee testing facility would also be required to refrigerate any
specimen that yields non-negative test results, Bottle B of any
specimen in Bottle A that tests as non-negative, and any specimen that
is not tested within 24 hours of receipt at the licensee testing
facility. These changes in the terminology of the proposed paragraph
would be made to improve clarity in the language of the proposed rule.
Proposed Sec. 26.129(g) and (h) would separate current Section
2.4(i) in Appendix A to Part 26 into two paragraphs for organizational
clarity and amend the current provision for the reasons previously
discussed with respect to proposed Sec. 26.117(i) and (k). Proposed
Sec. 26.129(g) and (h), which repeat the requirements for packaging
and shipping specimens contained in proposed Sec. 26.117(i) and (k) of
Subpart E [Collecting specimens for testing], would apply these
requirements to packaging and shipping specimens from licensee testing
facilities to HHS-certified laboratories. The bases for these
requirements are discussed with respect to proposed Sec. Sec.
26.117(i) and (k).
Section 26.131 Cutoff Levels for Validity Screening and Initial
Validity Tests
A new Sec. 26.131 [Cutoff levels for validity screening and
initial validity tests] would be added to establish cutoff levels for
validity screening and initial validity tests at licensee testing
facilities for creatinine, pH, and oxidizing adulterants. The
procedures, substances, and cutoff levels for initial validity testing
in the proposed section would incorporate the related requirements from
the HHS Guidelines (69 FR 19643; April 13, 2004). The proposed validity
screening test requirements would be adapted from the HHS proposed
revision to the Guidelines that was also published in the Federal
Register on April 13, 2004 (69 FR 19673).
By contrast to the requirements for initial validity testing in the
HHS Guidelines, the proposed rule would not require licensee testing
facilities to evaluate the specific gravity of a specimen that has a
creatinine concentration of less than 20 milligrams (mg) per deciliter
(dL). Specimens with a low creatinine concentration may be dilute or
substituted. Instead, if the specimen's creatinine concentration is
less than 20 mg/dL, the proposed rule would require the licensee
testing facility to forward the specimen to the HHS-certified
laboratory to complete the testing, where the specimen's specific
gravity would be measured. The proposed rule would differ from the HHS
Guidelines in this provision because the costs of the instruments
(i.e., refractometers) that are required in the Guidelines for
measuring specific gravity are high. Some licensee testing facilities
are currently measuring the specific gravity of specimens. However, the
cutoff levels established in the Guidelines require more sensitive
measurement and licensee testing facilities would be required to
purchase new equipment in order to test at the new HHS specific gravity
cutoff levels. Therefore, the proposed rule would require licensee
testing facilities to ship specimens with low creatinine concentrations
to the HHS-laboratory to complete the initial testing process and would
not include cutoff levels for specific gravity or quality control
requirements for measuring specific gravity in this proposed subpart.
The NRC invites comment on this issue.
Proposed Sec. 26.131(a) would be added to require licensee testing
facilities to perform either validity screening tests, initial validity
tests, or both. Consistent with related requirements for further
testing of specimens that yield drug-positive results from initial
testing at a licensee testing facility, the proposed rule would also
require licensee testing facilities to forward specimens that yield
non-negative validity testing results to an HHS-certified laboratory
for further testing. Further testing at an HHS-certified laboratory is
necessary because licensee testing facilities do not have the
sophisticated testing instruments for conducting confirmatory testing
that are required under the HHS Guidelines. In addition, further
testing at an HHS-certified laboratory provides an independent check on
test results from licensee testing facilities that is necessary to
protect donors' rights to due process under Part 26, consistent with
Goal 7 of this rulemaking.
As discussed in Section IV. C, the primary distinction between
validity screening tests and initial validity tests is that validity
screening tests may be performed using non-instrumented devices, such
as dipsticks, whereas initial validity tests generally rely upon more
complex testing technologies. The proposed rule would permit licensee
testing facilities to perform validity screening tests before
performing initial validity tests, but would not require them to do so,
because validity screening tests would be unnecessary if the licensee
testing facility will perform initial validity testing.
Proposed Sec. 26.131(b) would be added to require licensee testing
facilities to test each urine specimen for its creatinine
concentration, pH, and the presence of one or more oxidizing
adulterants, such as nitrite or bleach. Abnormal creatinine
concentrations and pH values, and the presence of oxidizing adulterants
are indicators that a specimen has been adulterated or substituted. The
proposed rule would permit the FFD program to choose the oxidizing
adulterant(s) for which testing would be conducted. The requirements in
this proposed paragraph would be consistent with the related
requirements in the current HHS Guidelines.
[[Page 50547]]
Proposed Sec. 26.131(b) would also establish the criteria for
determining whether a specimen must be forwarded to the HHS-certified
laboratory for further validity testing. The proposed criteria would be
incorporated from the current HHS Guidelines. Because validity testing
is complex and the methods for testing are relatively new, the proposed
rule would not permit an FFD program to establish more stringent cutoff
levels for validity screening and initial validity testing. This
proposed prohibition is necessary to decrease the risk of obtaining
false non-negative test results and would ensure that donors are not
subject to sanctions on the basis of inaccurate test results.
Section 26.133 Cutoff Levels for Drugs and Drug Metabolites
A new Sec. 26.133 [Cutoff levels for drugs and drug metabolites]
would amend current Section 2.7(e)(1) in Appendix A to Part 26, which
establishes cutoff levels for initial testing for drugs and drug
metabolites. Proposed Sec. 26.133 would replace and amend some cutoff
levels for initial tests for drugs and drug metabolites in current
Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with the
HHS cutoff levels for the same substances.
The initial test cutoff level for marijuana metabolites would be
decreased from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL.
Current immunoassay techniques can now reliably detect the presence of
marijuana metabolites at this cutoff level. As discussed in Section IV.
B, this proposed change would strengthen the effectiveness of FFD
programs by increasing the likelihood of detecting marijuana use.
The proposed rule would increase the initial test cutoff level for
opiate metabolites from 300 ng/mL in the current rule to 2,000 ng/mL.
The proposed change in the cutoff level for opiate metabolites would
substantially reduce the number of positive opiate test results that
are reported to MROs by HHS-certified laboratories that MROs ultimately
verify as negative.
The proposed rule would continue to permit licensees and other
entities to establish more stringent cutoff levels for initial drug
tests, subject to the requirements specified in proposed Sec.
26.31(d)(3)(iii), for the reasons discussed with respect to that
paragraph.
The current requirement for licensees and other entities to report
drug test results for both the cutoff levels in the rule and more
stringent cutoff levels would be eliminated in the proposed rule. The
reason that the current rule requires FFD programs to report test
results for the cutoff levels specified in this part, when the licensee
is using more stringent cutoff levels, is that it provides means for
the NRC to monitor licensees' implementation of the permission to use
more stringent cutoff levels. The proposed rule would eliminate this
requirement, because proposed Sec. 26.31(d)(3)(iii)(C) would require a
qualified forensic toxicologist to certify the scientific and technical
validity of the licensee's or other entity's testing process at any
lower cutoff levels. Therefore, the reporting requirement would no
longer be needed to assure licensee testing facility performance in
this area. Eliminating this requirement would meet Goal 5 of this
rulemaking, which is to improve Part 26 by eliminating or modifying
unnecessary requirements.
Section 26.135 Split Specimens
A new Sec. 26.135 [Split specimens] would reorganize and amend the
requirements contained in current Section 2.7(j) in Appendix A to Part
26 that relate to licensee testing facility handling of split
specimens. The proposed requirements would apply only if the FFD
program follows split specimen procedures. The current paragraph would
be divided into separate paragraphs in the proposed section to indicate
that each requirement stands on its own. This proposed change would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the organization and language of the rule.
Proposed Sec. 26.135(a) would amend the second, third, and fourth
sentences of current Section 2.7(j) in Appendix A to Part 26. The
proposed rule would revise the terminology used in these sentences
(e.g., ``Bottle A'' rather than ``primary specimen,'' ``Bottle B''
rather than ``split specimen,'' ``non-negative'' rather than
``presumptive positive'') to be consistent with terminology used in
other parts of the proposed regulation without amending the meaning of
the sentences. The requirement in the third sentence of current Section
2.7(j) to seal the split specimen prior to placing it in secure storage
would be deleted in the proposed rule, because Bottles A and B would
have already been sealed at the collection site, as required in
proposed Sec. 26.113(b)(3). The proposed paragraph would add a
requirement to forward Bottle A of the split specimen to the HHS-
certified laboratory, in the case of any non-negative validity test
results at the licensee testing facility. This proposed requirement
would be consistent with the addition of requirements to conduct
validity testing throughout the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.135(b) would amend the requirements in current
Section 2.7(j) in Appendix A to Part 26 related to donor requests for
testing of the specimen in Bottle B. The proposed paragraph would add
non-negative validity test results as a basis for a donor request for
testing the specimen in Bottle B consistent with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i). The
proposed paragraph would also add a requirement that the donor must
request testing of the Bottle B specimen within 3 business days of
being notified by the MRO that the specimen in Bottle A has yielded
confirmed non-negative test results. Since 1994, the HHS Guidelines
have allowed up to 72 hours for a donor to make this request, so the
proposed change would increase the consistency of Part 26 with the HHS
Guidelines to meet Goal 1 of this rulemaking, which is to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
The proposed paragraph would also eliminate the requirement in the
fourth sentence of current Section 2.7(j) in Appendix A to Part 26,
which requires that the split specimen must be forwarded to another
HHS-certified laboratory for testing on the same day of the donor
request. Licensees and other entities would be permitted up to one
business day to forward Bottle B to a second HHS-certified laboratory
following the donor request. This proposed change would respond to
stakeholder feedback provided during the public meetings discussed in
Section V. The stakeholders reported that implementing the same-day
requirement has often been difficult for a number of reasons,
including, for example, communication delays among donors, MROs, and
FFD program personnel, particularly on weekends and holidays, and the
time required to identify a second laboratory with the appropriate
capability to test the split specimen, depending upon the nature of the
non-negative test result. The proposed rule would alleviate some of
these types of logistical difficulties (e.g., logistical problems
associated with weekends and holidays) while continuing to provide the
donor with timely test results. Therefore, this proposed change would
be made to meet Goal 5 of this rulemaking, which is to improve Part 26
by eliminating or modifying unnecessary requirements.
[[Page 50548]]
The proposed paragraph would also require the donor to provide
written permission to the licensee or other entity for testing of the
specimen contained in Bottle B and clarify that only the donor may
authorize testing of Bottle B. Stakeholders have indicated that the
requirement for a written request from donors would impose a
substantial logistical burden for donors who may not be working on site
when contacted by the MRO. However, the NRC believes that the proposed
requirement is necessary to ensure that the donor's right to privacy
and control of the specimen would be protected, consistent with Goal 7
of this rulemaking, which is to protect the privacy and due process
rights of individuals who are subject to Part 26.
Proposed Sec. 26.135(c) would update the terminology used in the
portions of current Section 2.7(h) in Appendix A to Part 26 that apply
to storing specimens at licensee testing facilities. For example, the
proposed provision would replace the term, ``split specimen,'' with the
term, ``Bottle B.'' The proposed paragraph would continue to require
licensee testing facilities who retain Bottle B of a confirmed non-
negative split specimen to store it in long-term frozen storage for at
least one year before discarding it, or longer if the specimen is under
legal challenge, or at the request of the NRC. The proposed rule would
extend the current requirement to apply to Bottle B of any specimen
that has yielded non-negative validity test results, consistent with
the addition of requirements to conduct validity testing throughout the
proposed rule, as discussed with respect to proposed Sec.
26.31(d)(3)(i). The portions of current Section 2.7(h) in Appendix A to
Part 26 that apply to HHS-certified laboratories would be moved to
Sec. 26.159(i) in proposed Subpart G [Laboratories Certified by the
Department of Health and Human Services] to improve the organizational
clarity of the rule.
Section 26.137 Quality Assurance and Quality Control
A new Sec. 26.137 [Quality assurance and quality control] would
amend current Section 2.8 in Appendix A to Part 26. The proposed
section would add quality control requirements for performing validity
screening tests, initial validity tests, and initial tests for drugs
and drug metabolites at the licensee testing facility, for the reasons
to be discussed with respect to each proposed paragraph. The portions
of current Section 2.8 in Appendix A to Part 26 that establish
requirements for HHS-certified laboratories would be moved to Sec.
26.167 in proposed Subpart G [Laboratories Certified by the Department
of Health and Human Services] for organizational clarity.
Proposed Sec. 26.137(a) [Quality assurance program] would amend
current Section 2.8(a) in Appendix A to Part 26, which requires
licensee testing facilities and HHS-certified laboratories to have a
quality assurance program for all aspects of the testing process. The
requirements for HHS-certified laboratories would be moved to Sec.
26.167(a) in proposed Subpart G [Laboratories Certified by the
Department of Health and Human Services] to improve organizational
clarity. The proposed paragraph would extend the current requirements
for licensee testing facilities to have a quality assurance program and
procedures to validity testing at the licensee testing facility,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.137(b) [Performance testing and quality control
requirements for validity screening tests] would be added to establish
requirements for conducting validity screening tests for the reasons
discussed with respect to proposed Sec. 26.31(d)(3)(i). The proposed
requirements in this paragraph are based upon requirements that have
been proposed by HHS in a Notice of Proposed Revisions to the Mandatory
Guidelines dated April 13, 2004 (69 FR 19673).
Proposed Sec. 26.137(b)(1) would permit licensee testing
facilities to use non-instrumented devices, such as dipsticks, to
determine whether a specimen appears to be valid or must be subject to
further validity testing. However, in proposed Sec. 26.137(b)(1)(i)
and (ii), licensee testing facilities would be permitted to use only
non-instrumented devices that either have been cleared by the U.S. Food
and Drug Administration and placed on the SAMHSA list of point-of-
collection testing devices that are certified for use in the Federal
Workplace Drug Testing Program, as published in the Federal Register,
or that meet the performance testing criteria set forth in proposed
Sec. 26.137(b)(1)(ii). SAMHSA has yet to publish a list of certified
devices, but, in order to be added to SAMHSA's list, SAMHSA will
require that a device must meet the performance testing requirements
that are contained in proposed Sec. 26.137(b)(1)(ii). Therefore,
adding these requirements to the proposed rule would permit licensee
testing facilities to conduct the required performance testing and
begin using any devices that meet the criteria before SAMHSA's list is
published.
The NRC is aware that the performance testing requirements in
proposed Sec. 26.137(b)(1)(ii) are stringent and that few, if any,
validity screening devices are yet available that meet them. However,
because individuals may be subject to a temporary administrative
withdrawal of authorization on the basis of a non-negative initial drug
test result for marijuana or cocaine from a specimen that appears to be
valid [see proposed Sec. 26.75(i)], it is critical that any validity
screening devices used in Part 26 programs provide accurate results.
The proposed performance testing requirements would be necessary to
protect donors from inaccurate results, as well as ensure that
specimens of questionable validity would be detected.
Proposed Sec. 26.137(b)(1)(iii) and (b)(1)(iv) would require
licensee testing facilities to ensure that any validity screening
devices placed into service continue to be effective in determining the
validity of urine specimens. Proposed Sec. 26.137(b)(1)(iii) would
require licensee testing facilities to ensure that the device(s) either
remains on the SAMHSA list of certified devices (when it becomes
available) or continues to meet the performance testing criteria in
proposed Sec. 26.137(b)(1)(ii)(A)-(b)(1)(ii)(C) by conducting further
performance testing on a nominal yearly schedule. The proposed
requirement would be consistent with the related requirement in HHS's
proposed revisions to the Guidelines. Proposed Sec. 26.137(b)(1)(iv)
would require licensee testing facilities to ensure that the
manufacturer of any validity screening device used informs the licensee
or other entity of modifications to the device, so that the licensee or
other entity may determine whether additional performance testing is
required to demonstrate that the modified device continues to be
effective. These proposed provisions would be necessary to protect
donors from inaccurate results, as well as provide assurance that
specimens of questionable validity are detected.
Proposed Sec. 26.137(b)(2) would require licensee testing facility
personnel to use the validity screening device to test quality control
samples at the beginning of any 8-hour period during which validity
screening tests will be performed. The proposed rule would require the
quality control samples to consist of one sample that is certified as
negative and one that is non-negative for the specific validity test
for which the device is designed. For example, if the device tests for
nitrite, licensee testing
[[Page 50549]]
facility personnel would use a certified quality control sample
containing nitrite. If the device fails to perform correctly when
testing the quality control samples, the proposed rule would require
the licensee testing facility to stop using it immediately and initiate
the investigation required in proposed Sec. 26.137(f). If the test
result is a false negative, the last sentence of the proposed paragraph
would require the licensee or other entity to notify the NRC. The
proposed rule would not require notifying the NRC of a false positive
result because any specimen that yields a non-negative validity
screening test result would be forwarded to the HHS-certified
laboratory for further testing, and licensees and other entities would
be prohibited from taking any management actions until the HHS-
certified laboratory completes testing of the specimen and the MRO has
reviewed the results. Therefore, false positive test results from the
device would not impose a burden on donors. These proposed procedures
are necessary to protect donors from inaccurate test results, as well
as to provide assurance that specimens of questionable validity are
detected.
Proposed Sec. 26.137(b)(3) would require licensee testing facility
personnel to submit 1 out of every 10 donor specimens that yield
negative results using the device to the HHS-certified laboratory. If
the HHS-certified laboratory's results indicate that the device had
provided a false negative result, the proposed rule would require the
licensee testing facility to stop using the device immediately,
initiate the investigation required in proposed Sec. 26.137(f), and
notify the NRC.
The NRC notifications that would be required in proposed Sec.
26.137(a) and (b) would be necessary because false negative results
from a validity screening device could mean that some attempts to
subvert the testing process may not be detected. For example, if an
individual had adulterated his or her specimen and it was not detected
because of a faulty device, the licensee or other entity would have no
reason to terminate the individual's authorization. As a result, the
individual, who has demonstrated that he or she is not trustworthy and
reliable, would be permitted to perform job duties under this part and
pose a risk to public health and safety and the common defense and
security. The NRC would use the information to ensure that HHS is
notified of the device failure as well as inform other licensees and
entities who may also be using the device of the false negative results
to prevent additional testing errors. Therefore, the proposed
notifications would be necessary to protect donors from inaccurate test
results, to ensure that specimens of questionable validity are
detected, and to ensure that any problems with a device are detected
and corrected as soon as possible.
Proposed Sec. 26.137(b)(4) would require that any non-instrumented
validity screening device used by a licensee testing facility must be
capable of measuring creatinine to 1 decimal place. This proposed
requirement would be necessary to ensure that the device can support
the creatinine cutoff levels established in the HHS Guidelines, as
incorporated into the proposed rule.
Proposed Sec. 26.137(b)(5) and (b)(6) would establish quality
control requirements for performing validity screening tests for pH and
oxidizing adulterants, respectively. These proposed requirements would
incorporate the related requirements in the proposed HHS Guidelines.
Proposed Sec. 26.137(c) [Non-negative validity screening test
results] would be added to specify the actions that the licensee
testing facility must take if the results of validity screening tests
are non-negative. If validity screening test results are non-negative,
the proposed rule would require instrumented initial validity testing
either at the licensee testing facility or the HHS-certified
laboratory. This proposed provision would be consistent with current
requirements for handling specimens that test as drug-positive on
initial tests at a licensee testing facility. The proposed requirement
would be necessary to protect donors from inaccurate test results, as
well as provide assurance that specimens of questionable validity are
detected using the more sophisticated technologies required for
instrumented initial validity testing in the HHS Guidelines and the
proposed rule.
Proposed Sec. 26.137(d) [Quality control requirements for
performing initial validity tests] would be added to specify the
required methods for performing initial validity tests at a licensee
testing facility to ensure that initial validity testing at the
licensee testing facility would provide accurate results. The proposed
requirements in this paragraph would incorporate the related
requirements in the HHS Guidelines as revised on April 13, 2004 (69 FR
19644). The proposed paragraph would be added to meet Goal 1 of this
rulemaking, which is to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines.
Proposed Sec. 26.137(d)(1) would require licensee testing
facilities to measure creatinine concentration to 1 decimal place and
would establish requirements for the controls to be used in initial
tests for creatinine concentration.
Proposed Sec. 26.137(d)(2) would establish quality control
requirements for performing initial pH tests. Proposed Sec.
26.137(b)(2)(i)-(b)(2)(v) would specify the required calibrators and
controls for initial pH testing, based upon the type of testing
instrument used and whether a pH validity screening test has been
performed.
Proposed Sec. 26.137(d)(3) would establish quality control
requirements for performing initial tests for oxidizing adulterants,
including nitrite, and proposed Sec. 26.137(d)(4) would establish
quality control requirements for performing initial tests for ``other''
adulterants at the licensee testing facility.
Proposed Sec. 26.137(e) [Quality control requirements for initial
drug tests] would amend and combine portions of current Sections
2.7(d), 2.7(e)(1), and 2.8(b) in Appendix A to Part 26, which establish
quality control requirements for performing initial tests for drugs and
drug metabolites at licensee testing facilities. The proposed paragraph
would group together in one paragraph the current requirements that are
dispersed throughout the rule to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization of the rule.
Proposed Sec. 26.137(e)(1) would amend the first sentence of
current Section 2.7(e)(1) in Appendix A to Part 26 but retain the
intent of the current provision as it applies to licensee testing
facilities. The current and proposed paragraphs require licensee
testing facilities to use only immunoassay tests that meet the
requirements of the Food and Drug Administration for commercial
distribution. The requirements in the current paragraph related to
initial drug testing at HHS-certified laboratories would be moved to
Sec. 26.167(d)(1) of proposed Subpart G [Laboratories Certified by the
Department of Health and Human Services] to improve organizational
clarity in the rule.
In addition, the proposed paragraph would prohibit licensee testing
facilities from relying on drug test results from any devices they may
use to perform validity screening tests. This proposed prohibition
would be added because several non-instrumented devices are available
that combine tests for the presence of drugs and drug metabolites in a
urine specimen with tests for other attributes of a urine specimen,
such as creatinine concentration. The proposed
[[Page 50550]]
rule would permit licensee testing facilities to use such combination
devices for validity screening tests, if the devices meet the
requirements of proposed Sec. 26.137(b)(1). However, the drug testing
capabilities of these devices are not yet sufficiently accurate and
sensitive to be used in Part 26 programs, in which licensees and other
entities would be permitted to administratively withdraw an
individual's authorization on the basis of positive initial drug test
results for marijuana and cocaine metabolites. The NRC may consider
accepting the use of initial drug test results from non-instrumented
devices in a future rulemaking, when HHS publishes a final revision to
the Mandatory Guidelines that establishes requirements for their use in
Federal workplace drug testing programs. At this time, however, the
proposed rule would retain the current prohibition on using such
devices for drug testing at licensee testing facilities.
Proposed Sec. 26.137(e)(2) would be added to require licensee
testing facilities to either discard specimens that yield negative
results from initial tests at the licensee testing facility or pool
them and use these specimens as quality control specimens, if the
specimens are certified as drug negative and valid by an HHS-certified
laboratory. The proposed paragraph would incorporate the related
provision from the HHS Guidelines and would be added to meet Goal 1 of
this rulemaking, which is to update and enhance the consistency of Part
26 with advances in other relevant Federal rules and guidelines.
Proposed Sec. 26.137(e)(3) would permit licensee testing
facilities to conduct multiple tests of a single specimen for the same
drug or drug class. The requirements in the proposed paragraph would
also be consistent with a similar provision in the HHS Guidelines and
would be added for the same reasons discussed with respect to Sec.
26.137(e)(2).
Proposed Sec. 26.137(e)(4) would amend the first sentence of
current Section 2.8(b) in Appendix A to Part 26, which states that
licensee testing facilities are not required to assess their false
positive rates in drug testing. The proposed paragraph would retain the
intent of the current requirement, but the terminology used in the
paragraph would be revised to use the new terms that are used
throughout the proposed rule, e.g., ``initial'' rather than
``screening,'' as discussed with respect to proposed Sec. 26.5
[Definitions].
Proposed Sec. 26.137(e)(5) would amend the second sentence of
current Section 2.8(b) in Appendix A to Part 26, which requires
licensee testing facilities to submit specimens that yield negative
results from initial testing to the HHS-certified laboratory as a
quality control check on the licensee testing facility's drug testing
process. The proposed paragraph would retain the intent of the current
provision but make several changes to the specific requirements.
The proposed paragraph would use the term, ``analytical run,''
rather than the current term, ``test run,'' to reflect changes in
testing technologies that some licensee testing facilities have adopted
since the current rule was published. Requirements for blind
performance and other quality control testing in the current rule were
based on the assumption that specimens would be tested in batches.
However, many licensee testing facilities now conduct continuous
testing, and no longer test specimens in batches. Therefore, the
proposed rule would use the term, ``analytical run,'' to refer to both
batch and continuous processing, as defined in proposed Sec. 26.5
[Definitions]. This proposed change would be made to meet Goal 6 of
this rulemaking, which is to improve clarity in the language of the
rule.
The current rule does not establish a number or percentage of
negative specimens that licensee testing facilities are required to
submit to the HHS-certified laboratory for performance testing, which
has raised implementation questions from licensees who have wanted to
know how many specimens must be submitted. Therefore, to clarify the
current requirement to ``submit a sampling of specimens,'' the proposed
rule would require licensee testing facilities to forward at least one
specimen that yields negative drug test results from each analytical
run to the HHS-certified laboratory for performance testing. The
proposed paragraph would also establish 5 percent of the specimens
tested in each analytical run as the percentage of negative specimens
that the licensee testing facility must submit to the HHS-certified
laboratory for testing, except if 5 percent of an analytical run would
be a number less than one specimen. In the latter case, the licensee
testing facility would submit at least one negative specimen from the
analytical run. The proposed requirement would ensure the ongoing
evaluation of the accuracy of the licensee testing facility's initial
drug testing without imposing a large performance testing burden.
The proposed rule would move the requirement for testing blind
performance test samples in current Section 2.8(b) in Appendix A to
Part 26 to proposed Sec. 26.137(d)(7). The last sentence of the
current paragraph, which addresses performance testing of breath
analysis equipment for alcohol testing, would be moved to proposed
Sec. 26.91(e) in Subpart E [Collecting Specimens for Testing]. The
proposed rule would reorganize the current requirements and group them
with related requirements to meet Goal 6 of this rulemaking, which is
to improve clarity in the organization of the rule.
Proposed Sec. 26.137(e)(6) would amend the requirements of current
Section 2.8(c) in Appendix A to Part 26 and apply them to licensee
testing facilities. The proposed rule would apply requirements for
quality controls to licensee testing facilities to provide greater
assurance that initial drug tests performed by these facilities provide
accurate results. The increased performance testing would be necessary
because the proposed rule permits licensees and other entities to rely
on test results from other Part 26 programs to a greater extent than
the current rule. Therefore, it is necessary to ensure that any tests
performed at licensee testing facilities meet minimum standards. This
proposed change would meet Goal 3 of this rulemaking, which is to
improve the effectiveness of FFD programs.
Proposed Sec. 26.137(e)(6)(i)-(e)(6)(iii) would be added to
describe the required characteristics of the quality control samples
that the licensee testing facility must include in each analytical run
of specimens. The proposed paragraphs would require each analytical run
to include at least one negative quality control sample as well as
quality control samples targeted at 25 percent above the cutoff and at
75 percent of the cutoff level for each drug and drug metabolite for
which testing is conducted. The proposed requirements would be
consistent with the requirements for processing quality control samples
during initial drug testing in the HHS Guidelines.
Proposed Sec. 26.137(e)(7) would establish requirements for the
number of quality control samples to be included in each analytical run
at the licensee testing facility. The proposed rule would require that
a minimum of 10 percent of the specimens in each analytical run must be
quality control samples. The quality control samples included in the
run could be any combination of the types of quality control samples
specified in proposed Sec. 26.137(d)(6)(i)-(d)(6)(iii). However, the
proposed paragraph would require that one percent or at least one of
the quality control samples included in each run must be a blind
performance test sample. For example, if an analytical run tested 50
donor specimens, the
[[Page 50551]]
licensee testing facility would include 5 quality control samples in
the run. At least one of the 5 would be required to be a blind test
sample, and it could be either a blank or a sample fortified with a
drug or metabolite at either 25 percent above the FFD program's cutoff
level or at 75 percent of the cutoff level. The remaining 4 samples
could include any combination of blanks and fortified samples. Licensee
testing facilities would be expected to vary the drugs and drug
metabolites used to fortify the quality control samples. The licensee
testing facility would not send the quality control samples to the HHS-
certified laboratory for testing, but use them for internal quality
control purposes only. The proposed requirements in this paragraph
would incorporate the related requirements in the HHS Guidelines and
would meet Goal 1 of this rulemaking, which is to update and enhance
the consistency of Part 26 with advances in other relevant Federal
rules and guidelines.
Proposed Sec. 26.137(e)(8) would extend to licensee testing
facilities the existing requirement in the third sentence of the last
paragraph of current Section 2.8(c) in Appendix A to Part 26, which
requires HHS-certified laboratories to implement procedures to ensure
that carryover does not contaminate the testing of a donor's specimen
and to document the procedures. The proposed rule would extend this
requirement to licensee testing facilities because it is a standard
forensic practice that is necessary to ensure the integrity of the
testing process.
Proposed Sec. 26.137(f) [Errors in testing] would be added to
require licensees and other entities who maintain testing facilities to
investigate any errors or unsatisfactory performance of the testing
process, identify the cause(s) of the adverse conditions, and correct
them. The proposed rule would require the licensee or other entity to
document the investigation and any corrective actions taken. The
proposed revision would clarify that licensees must investigate any
testing errors or unsatisfactory performance identified throughout the
testing process or during the review process that would be required
under proposed Sec. 26.91 [Review process for fitness-for-duty policy
violations]. The NRC intended, in the original rule, that testing or
process errors discovered in any part of the program, including through
the review process, be investigated as an unsatisfactory performance of
a test. Thorough investigation and reporting of such test results will
continue to assist the NRC, the licensees, HHS, and the HHS-certified
laboratories in preventing future occurrences. The proposed paragraph
would also require the cause of the condition be determined and
corrective action be taken and documented for consistency with
Criterion XVI in Appendix B of 10 CFR Part 50.
Proposed Sec. 26.137(g) [Accuracy] would retain current Section
2.7(o)(3)(i) in Appendix A to Part 26, which requires checking the
instruments used in testing for accuracy, as it applies to licensee
testing facilities. The proposed rule would move the current
requirement as it relates to HHS-certified laboratories to Sec.
26.167(h) in proposed Subpart G [Laboratories Certified by the
Department of Health and Human Services] for organizational clarity.
Proposed Sec. 26.137(h) [Calibrators and controls] would update
current Section 2.7(o)(2) in Appendix A to Part 26, which establishes
requirements for the standards and quality control samples used for
performance testing. At the time the original paragraph was written,
most laboratories prepared their own standards and controls. In the
ensuing years, the number and variety of sources for materials used in
performance testing have increased. The proposed paragraph would update
the existing requirements to refer to several of the alternatives,
including, but not limited to, pure drug reference materials, stock
standard solutions from other laboratories, and standard solutions
obtained from commercial manufacturers. The proposed requirements in
this paragraph would incorporate the related requirements in the HHS
Guidelines and would meet Goal 1 of this rulemaking, which is to update
and enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines.
Section 26.139 Reporting Initial Validity and Drug Test Results
A new Sec. 26.139 [Reporting initial validity and drug test
results] would combine existing requirements related to the reporting
and management of test results from the licensee testing facility that
are interspersed throughout current Appendix A to Part 26. This
proposed change would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization of the rule, by grouping
related requirements together in a single section.
Proposed Sec. 26.139(a) would amend current Section 2.7(g)(2) in
Appendix A to Part 26, which establishes requirements for the manner in
which HHS-certified laboratories and licensee testing facilities must
report test results to licensee management. The requirements in the
current paragraph that are related to reporting test results from HHS-
certified laboratories would be moved to Sec. 26.169(b) of proposed
Subpart G [Laboratories Certified by the Department of Health and Human
Services] for organizational clarity. The proposed paragraph would
delete the current reference to ``special processing'' and replace it
with reference to validity test results, consistent with the addition
of requirements to conduct validity testing throughout the proposed
rule, as discussed with respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.139(b) would amend the last sentence of current
Sec. 26.24(d)(1), which specifies the individuals to whom results of
initial tests from the licensee testing facility may be released. The
proposed paragraph would add the MRO's staff to the list of individuals
who would be permitted to have access to the results of initial tests
performed at the licensee testing facility consistent with the addition
of this job role to the proposed rule. Individuals who are serving as
MRO staff members would require access to initial test results from a
licensee's testing facility in the course of performing their
administrative duties for the MRO.
Proposed Sec. 26.139(c) would amend current Section 2.7(o)(5) in
Appendix A to Part 26. The requirements in the current paragraph that
address the availability of personnel to testify in proceedings related
to drug test results from an HHS-certified laboratory would be moved to
Sec. 26.153(f)(2) of proposed Subpart G [Laboratories Certified by the
Department of Health and Human Services] for organizational clarity.
The proposed rule would move the current requirement for licensee
testing facility personnel to be available to testify at any
proceedings with respect to breath analysis test results to proposed
Sec. 26.85(d) because licensee testing facilities are typically not
responsible for quality control of alcohol testing, which is conducted
at the collection site.
Proposed Sec. 26.139(d) would amend the portions of current
Section 2.7(g)(6) in Appendix A to Part 26 that apply to the summary
report that licensee testing facilities must provide to FFD program
management. The current requirement for the licensee testing facility
to prepare a monthly report of test results would be replaced with a
proposed requirement for the licensee testing facility to summarize the
data annually in the FFD program performance report required in
proposed Sec. 26.217(b). Experience implementing the current
requirement for a monthly statistical
[[Page 50552]]
summary has indicated that the monthly summary has not been as useful
to licensees for ongoing monitoring of testing program effectiveness as
other mechanisms that licensees have developed. Therefore, the
requirement in proposed Sec. 26.139(f) for FFD program management to
monitor the ongoing effectiveness of the licensee testing facility
testing program would replace the monthly reporting requirement in
Section 2.7(g)(6). This proposed change would meet Goal 5 of this
rulemaking, which is to improve Part 26 by eliminating or modifying
unnecessary requirements. The requirements in the current paragraph
that address summary reports from HHS-certified laboratories would be
moved to Sec. 26.169(k) of proposed Subpart G [Laboratories Certified
by the Department of Health and Human Services] for organizational
clarity.
Proposed Sec. 26.139(e) would amend current Section 2.7(g)(7) in
Appendix A to Part 26, which requires licensee testing facilities and
HHS-certified laboratories to report test results for both the cutoff
levels specified in this part and any more stringent cutoff levels used
by the FFD program. The current requirement related to HHS-certified
laboratories would be relocated to Sec. 26.169(c) of proposed Subpart
G [Laboratories Certified by the Department of Health and Human
Services] for organizational clarity. The proposed rule would require
licensees and other entities who operate testing facilities and have
adopted more stringent cutoff levels for initial tests for drugs and
drug metabolites than those specified in proposed Sec. 26.133 [Cutoff
levels for drugs and drug metabolites], to conduct tests and report
test results based only on their more stringent cutoff levels. The
basis for the current requirement to conduct tests and report test
results for the cutoff levels specified in this part, when the licensee
is using more stringent cutoff levels, was a method by which the NRC
monitored licensee implementation of the permission to use more
stringent cutoff levels. The proposed rule would eliminate this
requirement, because proposed Sec. 26.31(d)(3)(iii)(C) would require a
qualified forensic toxicologist to certify the scientific and technical
validity of the licensee's or other entity's testing process at any
lower cutoff levels. Therefore, the testing and reporting requirement
would no longer be needed to monitor licensee testing facility
performance in this area. The proposed rule would continue to require
licensee testing facilities to report test results (and the cutoff
levels used) from testing for additional drugs and drug metabolites,
beyond those specified in proposed Sec. 26.31(b)(1).
Proposed Sec. 26.139(f) would be added to require FFD program
management to monitor the ongoing effectiveness of the licensee testing
facility testing program. The proposed rule would provide examples of
the types of information and possible program performance indicators
that licensees and other entities may use for program monitoring. The
proposed rule would also require FFD program management to make
adjustments to the testing program in response to information gained
from the ongoing monitoring. The proposed requirements would replace
the current monthly summary reporting requirement in current Section
2.7(g)(7) in Appendix A to Part 26 to strengthen FFD programs by
ensuring that licensees monitor licensee testing facility performance
on an ongoing basis and correct any weaknesses as they are identified.
The proposed paragraph also would be consistent with the NRC's
performance-based approach to regulation. This proposed change would
meet Goal 3 of this rulemaking, which is to improve the effectiveness
of FFD programs, as discussed in Section IV. B.
Subpart G--Laboratories Certified by the Department of Health and Human
Services
Section 26.151 Purpose
Proposed Sec. 26.151 [Purpose] would be added to introduce the
purpose of the proposed subpart, which is to establish requirements for
the HHS-certified laboratories that licensees and other entities must
use for testing urine specimens for validity and the presence of drugs
and drug metabolites. This proposed section would be added to meet Goal
6 of this rulemaking, which is to improve clarity in the organization
and language of the rule. The majority of the requirements in this
proposed subpart would be based upon the current requirements in
Appendix A to Part 26, as they relate to HHS-certified laboratories.
However, the current requirements would be updated to be consistent
with the Department of Health and Human Services' revisions to the
Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS
Guidelines), as published in the Federal Register on April 13, 2004 (69
FR 19643).
Section 26.153 Using Certified Laboratories for Testing Urine Specimens
A new Sec. 26.153 [Using certified laboratories for testing urine
specimens] would be added to present together requirements related to
the use of HHS-certified laboratories by licensees and other entities
who would be subject to the rule.
Proposed Sec. 26.153(a) would combine and update current
requirements for licensees and other entities to use HHS-certified
laboratories for initial and confirmatory drug testing of urine
specimens. The proposed paragraph would relocate and combine current
Sec. 26.24(f), the second sentence of Section 1.1(3), and Section
4.1(a) in Appendix A to Part 26, which require licensees and other
entities to use HHS-certified laboratories for drug testing. The
proposed change would be made to eliminate redundancies in the current
rule and improve organizational clarity. The proposed paragraph would
update the current citations for the HHS Guidelines because the
Guidelines have been amended several times since the current rule was
published. In addition, the proposed rule would provide current contact
information for obtaining information about the certification status of
HHS-certified laboratories because the contact information also has
changed since the current rule was published. The proposed paragraph
would also add a requirement for licensees and other entities to use
HHS-certified laboratories for initial and confirmatory validity
testing, consistent with the addition of urine specimen validity
testing requirements to the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i). The cross-reference to current Sec.
26.24(d), which permits licensee testing facilities to conduct initial
drug tests, would be updated to reference the related provision in the
proposed rule, proposed Sec. 26.31(d)(3)(ii).
Proposed Sec. 26.153(b) would amend the first sentence of current
Section 2.7(l)(2) in Appendix A to Part 26, which requires HHS-
certified laboratories to have the capability, at the same laboratory
premises, of performing initial and confirmatory tests for any drug and
drug metabolite for which service is offered and confirmatory testing
of blood for alcohol concentrations. The current requirement for HHS-
certified laboratories to be capable of conducting confirmatory alcohol
testing of blood would be deleted for the reasons discussed with
respect to proposed Sec. 26.83(a). The proposed paragraph would add a
requirement for HHS-certified laboratories to have the capability to
perform both initial validity and confirmatory validity tests at the
same premises for consistency with the
[[Page 50553]]
addition of requirements to perform validity testing to the proposed
rule, as discussed with respect to proposed Sec. 26.31(d)(3)(i). The
second sentence of current Section 2.7(l)(2), which establishes
requirements for the capabilities of licensee testing facilities, would
be moved to proposed Sec. 26.123 [Licensee testing facility
capabilities] of Subpart F [Licensee Testing Facilities] for
organizational clarity. The last sentence of the current paragraph,
which permits the testing of breath specimens for alcohol at the
collection site, would be deleted because the proposed rule would
address alcohol testing in Subpart E [Collecting Specimens for
Testing]. These organizational changes to the current paragraph would
be made to meet Goal 6 of this rulemaking, which is to improve clarity
in the organization and language of the rule.
Proposed Sec. 26.153(c) would amend the first sentence of current
Section 2.7(k) in Appendix A to Part 26, which restricts HHS-certified
laboratories from subcontracting unless authorized by the licensee. The
proposed rule would extend this restriction to subcontracting for
specimen validity testing for consistency with the addition of
requirements to perform validity testing to the proposed rule, as
discussed with respect to proposed Sec. 26.31(d)(3)(i). The second
sentence of current Section 2.7(k) would be deleted from the proposed
paragraph for several reasons: First, the requirement to have the
capability to test for marijuana, cocaine, opiates, phencyclidine, and
amphetamines would be deleted because it is redundant with proposed
Sec. 26.31(d)(1). The requirement to be capable of testing whole blood
would be deleted because the proposed rule would no longer permit
donors to request confirmatory alcohol testing of blood for the reasons
discussed with respect to proposed Sec. 26.83(a). Finally, the
requirement for laboratories to be capable of conducting GC/MS testing
would be eliminated because HHS-certified laboratories would be
permitted to use other methods of confirmatory testing, consistent with
related revisions to the HHS Guidelines.
Proposed Sec. 26.153(d) would amend current Section 4.1(b) in
Appendix A to Part 26, which requires licensees and C/Vs to use only
HHS-certified laboratories who agree to follow the same rigorous
testing, quality control, and chain-of-custody procedures when testing
for more stringent cutoff levels, additional drugs to those for which
testing is required under Part 26, and blood. The proposed paragraph
would eliminate reference to testing for blood because the proposed
rule would no longer permit donors to request confirmatory alcohol
testing of blood for the reasons discussed with respect to proposed
Sec. 26.83(a).
Proposed Sec. 26.153(e) would amend the third sentence of current
Section 2.7(m) in Appendix A to Part 26, which requires licensees to
conduct an inspection and evaluation of a laboratory's drug testing
operations before using the laboratory's services. Some licensees have
incorrectly interpreted the current regulation as requiring licensee
employees to perform the pre-award inspection and evaluation. In many
cases, however, appropriately qualified licensee employees may not be
available to perform the inspection and evaluation, and the use of
contracted experts may be necessary to achieve the NRC's intent. The
proposed paragraph would revise the current requirement to indicate
that licensees and other entities would be responsible ``to ensure''
that the inspection and evaluation is performed, in order to clearly
indicate that the use of expert contractors is acceptable. In addition,
the proposed rule would clarify that the pre-award inspection and
evaluation must be performed by qualified individuals.
Proposed Sec. 26.153(e) also would permit a licensee or other
entity to begin using the services of another HHS-certified laboratory
immediately, without a pre-award evaluation and inspection, in the
event that the licensee's or other entity's primary laboratory loses
its certification. To be considered acceptable, the proposed rule would
require that the replacement laboratory must be in use by another Part
26 program. The proposed rule would add this provision to ensure that
testing can continue, in the event that the HHS-certified laboratory
upon which a licensee or other entity relies loses its certification,
as some licensees have experienced. Related requirements for auditing
the replacement laboratory would be specified in proposed Sec.
26.41(g)(5).
Proposed Sec. 26.153(f) would be added to require that licensees'
and other entities' contracts with HHS-certified laboratories must
require the laboratories to implement the applicable requirements of
this part. Because the NRC does not regulate HHS-certified
laboratories, this revision would ensure that the Agency has a legal
basis for requiring HHS-certified laboratories to comply with this part
when conducting testing for licensees and other entities.
Proposed Sec. 26.153(f)(1) would retain the requirement in current
Section 2.7(l)(1) in Appendix A to Part 26, which states that HHS-
certified laboratories must comply with applicable State licensor
requirements. The proposed paragraph would replace the term, ``HHS-
certified laboratories,'' with the term, ``laboratory facilities,'' to
clarify that State requirements apply to laboratory facilities rather
than to the HHS-certified laboratory as a corporate entity. The
proposed clarification would be necessary because some HHS-certified
laboratories are operated by large national corporations with
facilities in several different States, and only the facilities in a
specific State would be required to meet the requirements of that
State. The proposed change would be made for clarity in the language of
the proposed rule as well as consistency with the HHS Guidelines.
Proposed Sec. 26.153(f)(2) would amend current Section 2.7(o)(5)
in Appendix A to Part 26, which requires that HHS-certified
laboratories must make available qualified personnel to testify in
proceedings based on urinalysis results reported by the laboratory.
Reference to licensee testing facilities would be moved to Sec.
26.139(c) in proposed Subpart F [Licensee Testing Facilities] for
organizational clarity. The requirement for qualified personnel to be
available to testify in proceedings related to breath analysis results
would be moved to proposed Sec. 26.85(d) in proposed Subpart E
[Collecting Specimens for Testing] for organizational clarity and
because responsibility for testifying with respect to breath analysis
results would reside with the licensee's or other entity's collection
site personnel.
Proposed Sec. 26.153(f)(3) would update current Section 3.1 in
Appendix A to Part 26, which requires HHS-certified laboratories to
protect donors' records. The current requirement for licensee testing
facilities to protect donors' records would be subsumed within the
second sentence of proposed Sec. 26.37(a) for organizational clarity.
The cross-reference to current Sec. 26.29 would be updated to
reference proposed Sec. 26.39 [Protection of information].
Proposed Sec. 26.153(f)(4) would update current Section 3.2 in
Appendix A to Part 26. Specifically, the proposed rule would add a
reference to Section 503 of Public Law 100-71 to document the basis for
this requirement, which would be adapted from the HHS Guidelines. The
proposed paragraph would add a requirement for a donor to have access
to records relating to his or her validity test results for consistency
with the addition of validity testing requirements to the proposed
rule, as discussed with respect to proposed Sec. 26.31(d)(3)(i). The
[[Page 50554]]
proposed paragraph would delete the current reference to records
related to alcohol test results because HHS-certified laboratories
would no longer be testing blood specimens for alcohol, as discussed
with respect to proposed Sec. 26.83(a).
Proposed Sec. 26.153(f)(5) would be added to clarify that HHS-
certified laboratories must avoid relationships with a licensee's or
other entity's MRO(s) that may be construed as a potential conflict of
interest. The proposed paragraph would respond to the experiences of
other Federal agencies regarding apparent conflicts of interest
involving laboratories and MROs. Although the NRC is not aware of any
situations of this type in Part 26 programs, the integrity of the MRO
function is sufficiently important that incorporating this requirement
would be warranted to prevent potential conflict of interest concerns.
The proposed paragraph would be consistent with the related provision
in the HHS Guidelines.
Proposed Sec. 26.153(f)(6) would amend the requirements in the
first two sentences of current Section 2.7(m) in Appendix A to Part 26,
which require HHS-certified laboratories to permit the NRC, licensees,
and other entities to conduct inspections at any time, including
unannounced inspections. The proposed rule would delete, for
organizational clarity, the existing references to collection site
services and licensee testing facilities, which would be covered under
proposed Sec. 26.221 [Inspections]. The proposed paragraph would also
delete reference to confirmatory testing of blood specimens for alcohol
because HHS-certified laboratories would no longer be testing blood
specimens for alcohol, as discussed with respect to proposed Sec.
26.83(a).
Proposed Sec. 26.153(g) would require licensees and other entities
to provide a memorandum for the record to the HHS-certified
laboratories that they use to document why the licensee or other entity
is using a non-Federal custody-and-control form. Under the HHS
Guidelines, laboratories may reject any specimen that is submitted for
testing with a non-Federal custody-and-control form unless the licensee
or other entity provides a memorandum for the record. The proposed
paragraph would be necessary to prevent licensee's and other entity's
specimens from being rejected.
Section 26.155 Laboratory Personnel
Proposed Sec. 26.155 [Laboratory personnel] would update current
Section 2.5 in Appendix A to Part 26 to be consistent with revisions to
the HHS Mandatory Guidelines for Federal Workplace Drug Testing
Programs (HHS Guidelines) published in the Federal Register on April
13, 2004 (69 FR 19643).
Proposed Sec. 26.155(a) [Day-to-day management of the HHS-
certified laboratory] would amend current Section 2.5(a)(1) in Appendix
A to Part 26, which requires the HHS-certified laboratory to have a
qualified individual to assume responsibility for day-to-day management
of the HHS-certified laboratory. Specifically, the proposed paragraph
would replace the term, ``qualified individual,'' with the term,
``responsible person,'' for consistency with terminology that other
Federal agencies use to refer to this job role.
Proposed Sec. 26.155(a) would retain the majority of Section
2.5(a)(2), which establishes qualification requirements for the
responsible person. Proposed Sec. 26.155(a)(1)(i)-(a)(1)(iv) would
retain current Section 2.5(a)(2)(i)-(a)(2)(iv) in Appendix A to Part
26, with minor grammatical changes that would be consistent with
similar changes to the related provisions in the HHS Guidelines.
Proposed Sec. 26.155(a)(2) and (a)(3), which establish minimum
day-to-day management responsibilities of the responsible person, would
retain current Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26.
Proposed Sec. 26.155(a)(4) would amend current Section 2.5(a)(5)
in Appendix A to Part 26, which relates to the responsible person's
responsibility to maintain the laboratory's procedures manual. The
proposed paragraph would eliminate the current requirement for the
procedures to be maintained in a laboratory manual as unnecessarily
restrictive. Laboratories would be permitted to use other means to
maintain their procedures. The proposed paragraph would retain the
current requirements in the second and third sentences of Section
2.5(a)(5) in Appendix A to Part 26, which require the responsible
person to review, sign, and date the procedures when they are first
placed in use, changed, or a new individual assumes responsibility for
management of the laboratory, and maintain copies of them. The current
cross-reference to Section 2.7(o) in Appendix A to Part 26 would be
updated to reference proposed Sec. 26.157 [Procedures], consistent
with the organizational changes made to the rule.
Proposed Sec. 26.155(a)(5) and (a)(6) would retain current Section
2.5(a)(6) and (a)(7) in Appendix A to Part 26, which define the
responsible person's responsibilities with respect to maintaining a
quality assurance program and taking remedial actions to maintain
satisfactory laboratory operations.
Proposed Sec. 26.155(b) [Certifying scientist] would amend current
Section 2.5(b) in Appendix A to Part 26 to be consistent with changes
made to the related requirement in the HHS Guidelines. Consistent with
the HHS Guidelines, the proposed rule would provide more detailed
requirements with respect to the individual who validates test results
at the HHS-certified laboratory before they are transmitted to the
licensee's or other entity's MRO. In proposed Sec. 26.155(b)(1), a new
job title, ``certifying scientist,'' would replace the term,
``qualified individual(s),'' in the first sentence of current Section
2.5(b) in Appendix A to Part 26 for consistency with a related change
in the HHS Guidelines. Proposed Sec. 26.155(b)(2) would specify the
required qualifications of individuals who serve as certifying
scientists. Proposed Sec. 26.155(b)(3) would permit laboratories to
use more than one certifying scientist with differing responsibilities.
Proposed Sec. 26.155(c) [Day-to-day operations and supervision of
analysts] would retain current Section 2.5(c) in Appendix A to Part 26.
The proposed rule would make minor wording changes to the current
paragraph to increase the consistency of the wording in this provision
with that of the related provision in the HHS Guidelines.
Proposed Sec. 26.155(d) [Other personnel] and (e) [Training] would
retain current Section 2.5(d) and (e) in Appendix A to Part 26,
respectively.
Proposed Sec. 26.155(f) [Files] would amend current Section 2.5(f)
in Appendix A to Part 26. The proposed revisions would be consistent
with related requirements in the HHS Guidelines. The current
requirement for records of tests for color blindness would be
eliminated, consistent with a similar change to the HHS Guidelines.
Tests for color blindness would no longer be necessary because current
testing technologies provide means, other than color, for reading test
results.
Section 26.157 Procedures
A new Sec. 26.157 [Procedures] would reorganize and amend
requirements for procedures, which are interspersed throughout current
Appendix A to Part 26, including requirements contained in current
Sections 2.2 and 2.7 in Appendix A to Part 26. The proposed changes
would be made to meet Goal 6 of this rulemaking, which is to improve
organizational clarity by grouping
[[Page 50555]]
procedural requirements for HHS-certified laboratories in one section.
Proposed Sec. 26.157(a) would make minor editorial changes to the
first sentence of current Section 2.2 in Appendix A to Part 26, which
requires licensee testing facilities and HHS-certified laboratories to
have detailed procedures for conducting testing. The proposed rule
would delete the current reference to blood samples because donors
would no longer have the option to request blood testing for alcohol,
as discussed with respect to proposed Sec. 26.83(a). Reference to
licensee testing facilities would be moved to proposed Sec. 26.127(a)
in Subpart F [Licensee Testing Facilities] for organizational clarity.
The proposed rule would also delete reference to procedures for
specimen collections, because procedural requirements for specimen
collections would be relocated to proposed Subpart E [Collecting
Specimens for Testing].
Proposed Sec. 26.157(b) would combine and amend portions of the
requirements in the first sentence of current Sections 2.4(d) and
2.7(a)(2) in Appendix A to Part 26 related to the content and
implementation of specimen chain-of-custody procedures. The proposed
paragraph would retain the portions of the current paragraphs that
require HHS-certified laboratories to develop, implement, and maintain
written chain-of-custody procedures to maintain control and
accountability of specimens from receipt through completion of testing
and reporting of results, during storage and shipping to another HHS-
certified laboratory, and continuing until final disposition of the
specimens. The current requirements related to licensee testing
facilities would be moved to proposed Sec. 26.127(b) in Subpart F
[Licensee Testing Facilities] for organizational clarity. The proposed
rule would also remove references to custody-and-control procedures for
blood specimens because donors would no longer have the option to
request blood testing for alcohol, as discussed with respect to
proposed Sec. 26.83(a).
Proposed Sec. 26.157(c) would amend the portions of current
Section 2.7(o)(1) in Appendix A to Part 26 that address the required
content of procedures for HHS-certified laboratories. The proposed
paragraph would retain the portions of the current provision that
require laboratories to develop and maintain procedures to specify all
of the elements of the testing process, including, but not limited to,
the principles of each test and the preparation of reagents, standards,
and controls. The proposed paragraph would present the required topics
of the procedures in a list format in proposed Sec. 26.157(c)(1)-
(c)(12) to clarify that each topic stands on its own. The proposed
paragraph would eliminate the current requirement for the procedures to
be maintained in a laboratory manual, which is unnecessarily
restrictive. HHS-certified laboratories would be permitted to use other
means to maintain their procedures. For organizational clarity, two
portions of the current provision would be moved to other subparts of
the proposed rule that address related topics. Requirements for
licensee testing facility procedures would be moved to Sec. 26.127(c)
in proposed Subpart F [Licensee Testing Facilities]. In addition, the
proposed rule would move the last two sentences of current Section
2.7(o)(1), which specify records retention requirements, to Sec.
26.215(b)(4) of proposed Subpart J [Recordkeeping and Reporting
Requirements].
Proposed Sec. 26.157(d) would amend current Section 2.7(o)(3)(iii)
in Appendix A to Part 26, which requires procedures for the setup and
normal operation of testing instruments; a schedule for checking
critical operating characteristics for all instruments; tolerance
limits for acceptable function checks; and instructions for major
troubleshooting and repair. The proposed rule would make three changes
to the current provision for organizational clarity. The proposed
paragraph would present the required topics of the procedures in a list
format in proposed Sec. 26.157(d)(1)-(d)(3) to clarify that each topic
stands on its own. The current requirement to maintain records of
preventative maintenance would be relocated to proposed Sec.
26.215(b)(10) in Subpart J [Recordkeeping and Reporting Requirements].
And, the current requirements that apply to licensee testing facilities
would be moved to Sec. 26.127(d) in proposed Subpart F [Licensee
Testing Facilities].
Proposed Sec. 26.157(e) would amend current Section 2.7(o)(4) in
Appendix A to Part 26, which requires documented corrective actions if
systems are out of acceptable limits or errors are detected. The
requirements in the current paragraph that apply to licensee testing
facilities would be moved to Sec. 26.127(e) in proposed Subpart F
[Licensee Testing Facilities] for organizational clarity.
Section 26.159 Assuring Specimen Security, Chain of Custody, and
Preservation
Proposed Sec. 26.159 [Assuring specimen security, chain of
custody, and preservation] would be added to present in one section the
requirements of the proposed rule that apply to HHS-certified
laboratories with respect to the safeguarding of specimen identity,
integrity, and security. The proposed organizational change would be
made because requirements that address these topics are dispersed
throughout the current rule and grouping them together in a single
section would make them easier to locate.
Proposed Sec. 26.159(a) would amend current Section 2.7(a)(1) in
Appendix A to Part 26. Proposed Sec. 26.159(a) would retain the first
three sentences of current Section 2.7(a)(1) in Appendix A to Part 26,
which require HHS-certified laboratories to be secure and accessible
only to authorized personnel. For organizational clarity, the
requirements that apply to licensee testing facilities would be moved
to proposed Sec. 26.129(a) in Subpart F [Licensee Testing Facilities],
and the last sentence of the current paragraph, which establishes
recordkeeping requirements, would be moved to Sec. 26.215(b)(13) in
proposed Subpart J [Recordkeeping and Reporting Requirements]. In
addition, the last sentence of the proposed paragraph would be revised
for increased clarity in the requirement and would expand the list of
persons who would be authorized to have access to the laboratory to
include representatives of the Secretary of the Department of Health
and Human Services and emergency responders. This proposed change would
be made for consistency with the related provision in the HHS
Guidelines.
Proposed Sec. 26.159(b) would amend current Section 2.7(b)(1) in
Appendix A to Part 26, which establishes requirements for receiving
specimens at the HHS-certified laboratory and assuring their integrity
and identity. The proposed rule would retain the existing requirement
for the HHS-certified laboratory to report evidence of tampering to
licensees' or other entities' management within 24 hours of discovery,
as well as the requirement for the laboratory to document any evidence
of tampering on the specimen's custody-and-control form. The proposed
rule would move the current requirements related to licensee testing
facilities to Sec. 26.129(b) in proposed Subpart F [Licensee Testing
Facilities] for organizational clarity. Several requirements would also
be added to the proposed paragraph.
The proposed paragraph would require licensee or other entity
management personnel to ensure that an investigation is initiated if
any indications of specimen tampering are identified, and take
corrective actions if tampering is confirmed. The appropriate
corrective actions would depend upon
[[Page 50556]]
the nature of the tampering identified as a result of the
investigation. For example, if the investigation indicated that the
tampering was an attempt to subvert the testing process and the persons
involved were identified, licensee and other entity management
personnel would impose the sanctions in proposed Sec. 26.75(b) for a
subversion attempt. The proposed paragraph would also require the
licensee, other entity, or HHS-certified laboratory to correct any
systematic weaknesses in specimen custody-and-control procedures that
may be identified in the investigation, such as inadequate safeguarding
of specimen shipping containers. The proposed rule would add this
provision because some licensees have not investigated or taken
corrective actions in response to indications of tampering with
specimens under the current rule.
The proposed paragraph would also prohibit testing specimens if
there is a reason to believe that the specimens have been altered in
such a manner as to affect specimen identity and integrity. In these
circumstances, the proposed rule would require the licensee or other
entity to collect another specimen from the donors. Although the NRC is
not aware of any instances in which such circumstances have arisen in
Part 26 programs, the experience of other Federal agencies indicates
such tampering is possible. Therefore, the proposed requirement would
ensure that individuals would not be subject to sanctions for a non-
negative test result from a specimen that may not have been theirs. The
proposed change would meet Goal 7 of this rulemaking, which is to
protect the due process rights of individuals who are subject to Part
26. The additional provision would also be consistent with the
requirements of other Federal agencies.
Proposed Sec. 26.159(c) would update and combine current Section
2.7(b)(2) with portions of current Sections 2.9(n) and 3.1 in Appendix
A to Part 26, which establish requirements for chain-of-custody
procedures for specimens and aliquots at licensee testing facilities
and HHS-certified laboratories. The proposed rule would move the
requirements in the current paragraphs that are related to licensee
testing facilities to Sec. 26.129(c) in proposed Subpart F [Licensee
Testing Facilities] for organizational clarity. Proposed Sec.
26.159(c) would also include the requirements in current Sections
2.9(n) and 3.1 in Appendix A to Part 26, which require the laboratory
to maintain the original specimen and custody-and-control form in
secure storage at the HHS-certified laboratory. The proposed changes
would be made to reduce redundancies and improve the organization
clarity of the rule.
Proposed Sec. 26.159(d) and (e) would update the portions of
current Section 2.7(a)(2) in Appendix A to Part 26 that establish
requirements for HHS-certified laboratory personnel to maintain and
document the chain of custody for specimens and aliquots, by replacing
the current paragraph with two related provisions from the HHS
Guidelines. Proposed paragraph (d) in this section would require the
laboratory's internal custody-and-control form to allow for
identification of the donor, and documentation of the testing process
and transfers of custody of the specimen. The phrase, ``within the
laboratory,'' would be added to proposed paragraph (e) to clarify that
the requirement to document each instance of the handling and transfer
of specimens applies to internal laboratory activities and does not
apply to transfers involving couriers. The proposed rule would relocate
the requirements in the current paragraph that are related to licensee
testing facilities to Sec. 26.129(d) and (e) in proposed Subpart G
[Laboratories Certified by the Department of Health and Human Services]
for organizational clarity.
Proposed Sec. 26.159(f) and (g) would separate current Section
2.4(i) in Appendix A to Part 26 into two paragraphs, for the reasons
discussed with respect to the similar provisions of proposed Sec.
26.117(i) and (k) and Sec. 26.129(g) and (h). The proposed paragraphs
would repeat the requirements for packaging and shipping non-negative
specimens that would be presented in proposed Sec. 26.117(i) and (k)
of Subpart E [Collecting specimens for testing] and Sec. 26.129(g) and
(h) in Subpart F [Licensee Testing Facilities], but apply them to
packaging and shipping specimens from one HHS-certified laboratory to
another. The bases for these requirements are discussed with respect to
proposed Sec. 26.117(i) and (k).
Proposed Sec. 26.159(h) [Short-term refrigerated storage] would
replace current Section 2.7(c) in Appendix A to Part 26, which
establishes requirements for refrigerating urine specimens at the HHS-
certified laboratory and licensee testing facility to protect them from
degradation. The proposed rule would replace the current paragraph with
the simplified language of the related provision in the HHS Guidelines.
Requirements related to short-term refrigerated storage at licensee
testing facilities would be moved to Sec. 26.129(f) in proposed
Subpart F [Licensee Testing Facilities] for organizational clarity.
Proposed Sec. 26.159(i) [Long-term storage] would amend current
Section 2.7(h) in Appendix A to Part 26, which establishes requirements
for long-term frozen storage of positive urine specimens at HHS-
certified laboratories and licensee testing facilities. Requirements
related to long-term storage of specimens by licensee testing
facilities would be moved to proposed Sec. 26.135(c) in Subpart F
[Licensee Testing Facilities] for organizational clarity. The proposed
paragraph would add requirements for storing specimens that yield non-
negative validity test results, consistent with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i). The
reference to ``administrative or disciplinary proceedings'' in the
first sentence of the current paragraph would be eliminated because
there are other circumstances in which it may be necessary to have a
specimen available for retesting, including, but not limited to,
retesting an aliquot of an invalid specimen at a second HHS-certified
laboratory under proposed Sec. 26.161(g) [Additional testing by a
second laboratory]. The proposed rule would also update the terminology
used in the current paragraph by adding a reference to ``Bottle B'' of
a split specimen and replacing the term, ``positive,'' with the term,
``non-negative,'' to be consistent with the new terminology adopted
throughout the proposed rule. As discussed with respect to proposed
Sec. 26.5 [Definitions], these proposed changes in terminology would
be made to improve clarity in the language of the proposed rule.
Proposed Sec. 26.159(j) would be added to incorporate related
changes to the HHS Guidelines. The proposed paragraph would permit the
HHS-certified laboratory to discard negative specimens. The proposed
paragraph also would permit laboratories to pool specimens that are
certified to be negative for drugs and drug metabolites and valid, as
well as use them as quality control samples, as permitted under the HHS
Guidelines.
Section 26.161 Cutoff Levels for Validity Testing
A new Sec. 26.161 [Cutoff levels for validity testing] would be
added to establish maximum cutoff levels and methods for conducting
specimen validity testing at HHS-certified laboratories, consistent
with the addition of requirements to conduct validity testing
throughout the proposed rule, as discussed with respect to proposed
Sec. 26.31(d)(3)(i). The proposed rule would incorporate these
[[Page 50557]]
requirements from the HHS Guidelines as revised on April 13, 2004 (69
FR 19644) to meet, in part, Goal 1 of this rulemaking, which is to
update and enhance the consistency of Part 26 with advances in other
relevant Federal rules and guidelines.
Proposed Sec. 26.161(a) [Validity test results] would be added to
specify that laboratories must conduct initial and confirmatory
validity testing using two different aliquots of a urine specimen.
Proposed Sec. 26.161(b) [Initial validity testing] would be added
to establish requirements and cutoff levels for initial validity tests
to be performed at HHS-certified laboratories.
Proposed Sec. 26.161(b)(1)-(b)(6) would establish requirements for
validity tests that HHS-certified laboratories must conduct on a
primary specimen, which would be either a single specimen submitted by
an FFD program that does not follow split specimen procedures, or the
specimen contained in Bottle A of a split specimen. For initial
validity tests of each specimen, HHS-certified laboratories would
determine the creatinine concentration of each specimen in proposed
Sec. 26.161(b)(1)(i). If the creatinine concentration is less than 20
mg/dL, the laboratory would determine the specimen's specific gravity
in proposed Sec. 26.161(b)(1)(ii). Proposed Sec. 26.161(b)(1)(iii)
would require the laboratory to determine each specimen's pH. Proposed
Sec. 26.161(b)(1)(iv) would require the laboratory to test the
specimen for the presence of oxidizing adulterants, and proposed Sec.
26.161(b)(1)(v) would require additional validity testing, depending
upon the characteristics of the specimen.
Proposed Sec. 26.161(b)(2)(i)-(b)(2)(ix) would establish the
criteria for determining whether a specimen must be subject to
confirmatory validity testing.
Proposed Sec. 26.161(c) [Results indicating an adulterated
specimen] would be added to establish criteria for HHS-certified
laboratories to apply in determining whether to report to a licensee's
or other entity's MRO that a specimen is adulterated. Proposed Sec.
26.161(c)(1)-(c)(7) would specify results from initial and confirmatory
validity testing that would indicate that a specimen is adulterated.
The proposed paragraphs would also specify the appropriate testing
devices and instruments to be used for initial and confirmatory
validity tests. In general, the proposed paragraphs would require the
HHS-certified laboratory to report to the MRO that a urine specimen is
adulterated if it meets any one of the following criteria: (1) It is
confirmed to contain a substance that should not be present at all in
normal human urine; (2) it is confirmed to contain a substance which,
although it could be present in normal human urine, is found to be at a
concentration that appears to be completely inconsistent with human
physiology; or (3) it presents an acid/base balance (pH) that appears
to be inconsistent with human life. The proposed paragraphs would
address several substances that some donors have used to try to defeat
drug tests through ``in vitro'' contamination (i.e., adding the
substance to a urine specimen). These adulterants include substances
that create a urine pH inconsistent with human life, oxidizing
adulterants, chromium (VI), halogens, glutaraldehyde, pyridine, and
surfactants. These substances, when either placed into an already
voided urine or used in place of a urine specimen, generally either
attempt to defeat the chemistry of the test or destroy a drug that is
present. The NRC recognizes that this list will be updated and/or
modified as new substances and formulas are introduced, and as the HHS-
certified laboratories develop methods to detect them. Proposed Sec.
26.131(c)(8) would recognize that new adulterants will be found and,
therefore, would require HHS-certified laboratories to use appropriate
testing methods when conducting initial and confirmatory testing for
new adulterants for which cutoff levels and criteria have not yet been
established.
Proposed Sec. 26.161(d) [Results indicating a substituted
specimen] and (e) [Results indicating a dilute specimen] would
establish cutoff levels and criteria for a determination by the
laboratory that a specimen has been substituted or is dilute,
respectively. In proposed Sec. 26.161(d), the HHS-certified laboratory
would report to the MRO that a specimen is substituted if it contains
less than 2 mg/dL of creatinine and the specific gravity is less than
or equal to 1.001 or equal to or greater than 1.020. These low
creatinine concentrations combined with the highly skewed specific
gravity values indicate that the specimen is not human urine. In
proposed Sec. 26.161(e), the HHS-certified laboratory would be
required to report to the MRO that a specimen is dilute if it contains
2-20 mg/dL of creatinine and has a specific gravity of less than or
equal to 1.001 or equal to or greater than 1.020.
Proposed Sec. 26.161(f)(1)-(f)(10) [Results indicating an invalid
specimen] would be added to establish the criteria that HHS-certified
laboratories would apply when determining that a specimen is invalid.
In 1998, HHS established criteria for what were termed ``unsuitable''
specimens (Program Document 35, September 28, 1998). An unsuitable
specimen was defined as one that contained an interfering substance but
the laboratory could not determine the nature of the substance with
scientific certainty. In these circumstances, the laboratory could not
achieve a ``valid'' test result. The HHS recognized that in some cases,
an interfering substance could be a legitimately ingested medication
(some non-steroidal anti-inflammatories have been known to interfere
with the chemistry of some of the initial tests). However, it was also
recognized that many of these problem specimens actually contained an
adulterant which the laboratory could not specifically identify with
scientific certainty (the requirement for reporting a specimen as
adulterated). Therefore, the HHS adopted the term, ``invalid
specimen,'' to mean that the laboratory has determined that valid test
results cannot be obtained from a specimen or an unknown substance
interfered with the confirmatory test. The proposed rule would adopt
the term, ``invalid specimen,'' with the same meaning.
Proposed Sec. 26.161(g) [Additional testing by a second
laboratory] would be added to address circumstances in which an HHS-
certified laboratory suspects that a specimen is adulterated but cannot
identify the adulterant. The proposed paragraph would permit the
laboratory to transfer the specimen to a second HHS-certified
laboratory for additional testing, if the first HHS-certified
laboratory cannot identify a possible adulterant in the specimen using
their standard testing technologies and the licensee's or other
entity's MRO concurs with the additional testing. Personnel at the
first HHS-certified laboratory would consult with the licensee's or
other entity's MRO to determine whether to transfer the specimen to a
second laboratory for additional testing.
Proposed Sec. 26.161(h) [More stringent validity test cutoff
levels are prohibited] would be added to prohibit licensees and other
entities from requiring an HHS-certified laboratory to apply validity
testing cutoff levels and criteria that are more stringent than those
specified in this proposed section. Because validity testing is complex
and the methods for testing are relatively new, the proposed rule would
not permit an FFD program to establish more stringent cutoff levels for
validity testing. The proposed prohibition would be necessary to
decrease the risk of obtaining false non-negative test results and
ensure that donors are not subject
[[Page 50558]]
to sanctions on the basis of inaccurate test results.
Section 26.163 Cutoff Levels for Drugs and Drug Metabolites
Proposed Sec. 26.163 [Cutoff levels for drugs and drug
metabolites] would group together in one section, for organizational
clarity, the proposed requirements for conducting initial and
confirmatory tests for drugs and drug metabolites at HHS-certified
laboratories. The proposed section would also update requirements
related to cutoff levels for drugs and drug metabolites in the current
rule to meet Goal 1 of this rulemaking, which is to update and enhance
the consistency of Part 26 with advances in other relevant Federal
rules and guidelines.
Proposed Sec. 26.163(a) [Initial drug testing] would amend current
Section 2.7(e) in Appendix A to Part 26. When determining whether to
report to the MRO that a specimen is positive for drug(s) or drug
metabolite(s), proposed Sec. 26.163(a)(1) would require HHS-certified
laboratories to apply the same cutoff levels that licensee testing
facilities would be required to use in proposed Sec. 26.133 [Cutoff
levels for drugs and drug metabolites], except if the FFD program
specifies more stringent cutoff levels or the specimen is dilute, as
discussed further with respect to proposed Sec. 26.163(a)(2). The
proposed paragraph would reiterate the current permission for licensees
and other entities to establish lower cutoff levels. In addition,
proposed Sec. 26.163(a)(1) would decrease the initial test cutoff
level for marijuana metabolites from 100 nanograms (ng) per milliliter
(mL) to 50 ng/mL and increase the initial test cutoff level for opiate
metabolites from 300 ng/mL to 2,000 ng/mL for the reasons discussed
with respect to proposed Sec. 26.133. The proposed changes would be
consistent with the HHS cutoff levels for the same substances.
Proposed Sec. 26.163(a)(2) would be added to establish
requirements and criteria for the initial drug testing of any specimen
that confirmatory validity testing indicates is dilute. Although there
are many legitimate reasons that a donor may provide a urine specimen
that is dilute, dilution is also a method used to subvert the testing
process. Dilution of a specimen decreases the concentration of any
drugs or drug metabolites in the specimen. Dilution may decrease the
concentration sufficiently that applying the cutoff levels specified in
this part, or a licensee's or other entity's more stringent cutoff
levels, would provide false negative drug test results. Therefore, the
proposed rule would add special testing procedures and criteria for
determining which dilute specimens must be subject to confirmatory drug
testing.
The proposed paragraph would require HHS-certified laboratories to
conduct initial drug testing of dilute specimens using FDA-approved
analytical kits that have the lowest concentration levels available for
the initial testing technologies used. If responses from the dilute
specimen on the initial drug test are within 50 percent of the
established cutoff level for the drug or drug metabolite, the proposed
rule would require the HHS-certified laboratory to report this result
to the licensee's or other entity's MRO. If the FFD program's policy
specifies this requirement, the proposed rule would permit the MRO to
direct the HHS-certified laboratory to test the specimen at the
confirmatory assay's LOD for that drug or drug class and report the
results to the MRO. This special processing of dilute specimens would
increase the likelihood that any drugs and drug metabolites in the
specimen would be detected. Therefore, this proposed requirement would
meet Goal 3 of this rulemaking, which is to improve the effectiveness
of FFD programs, by increasing the likelihood that testing of dilute
specimens would reveal drug use, if the donor had engaged in substance
abuse.
As discussed with respect to proposed Sec. 26.133 [Cutoff levels
for drugs and drug metabolites], the proposed rule would eliminate the
requirement in the last sentence of current Section 2.7(e)(1) for HHS-
certified laboratories to report drug test results for both the cutoff
levels in the rule and any more stringent cutoff levels that the
licensee or other entity may establish. The basis for the current
requirement to report test results for the cutoff levels specified in
this part, when the licensee is using more stringent cutoff levels, was
a means by which the NRC monitored implementation of the permission to
use more stringent cutoff levels. The proposed rule would eliminate
this requirement, because proposed Sec. 26.31(d)(3)(iii)(C) would
require a qualified forensic toxicologist to certify the scientific and
technical validity of any testing at lower cutoff levels. Therefore,
the current reporting requirement is no longer needed to assure
laboratory performance in this area. Eliminating this requirement would
meet Goal 5 of this rulemaking, which is to improve Part 26 by
eliminating or modifying unnecessary requirements.
The proposed rule would also eliminate current Section 2.7(e)(2),
which states that the list of substances and cutoff levels contained in
Appendix A to Part 26 are subject to change by the NRC. At the time the
current rule was published, the NRC expected to be able to amend the
list of substances and cutoff levels in Appendix A to Part 26 without
additional rulemaking. However, the NRC has determined that rulemaking
is required to make such changes. Therefore, the proposed rule would
delete this paragraph because it is unnecessary.
The proposed rule would replace current Section 2.7(f) in Appendix
A to Part 26, which establishes cutoff levels and requirements related
to confirmatory testing for drugs and drug metabolites at the HHS-
certified laboratory, with proposed Sec. 26.163(b) [Confirmatory drug
testing]. The proposed rule would also make a number of changes to the
current paragraph.
The proposed rule would move current Section 2.7(f)(1) in Appendix
A to Part 26 to proposed Sec. 26.169(b). Current Section 2.7(f)(1)
requires the HHS-certified laboratory to report to the MRO that test
results are negative for any specimens that yield negative test results
when they are subjected to confirmatory testing. This requirement would
be moved to proposed Sec. 26.169(b) for organizational clarity because
proposed Sec. 26.169 [Reporting results] addresses the topic of
reporting test results by the HHS-certified laboratory to the MRO.
The proposed rule would also eliminate the requirement in current
Section 2.7(f)(1) in Appendix A to Part 26 that the laboratory must
conduct confirmatory testing using both the maximum cutoff values
established in Part 26 as well as any more stringent cutoff levels
adopted by the licensee's or other entity's FFD program. The current
requirement to conduct testing for the cutoff levels specified in this
part, when the licensee is using more stringent cutoff levels, was a
means by which the NRC monitored implementation of the permission to
use more stringent cutoff levels. The proposed rule would eliminate
this requirement, because proposed Sec. 26.31(d)(3)(iii)(C) would
require a qualified forensic toxicologist to certify the scientific and
technical validity of any testing at lower cutoff levels. Therefore,
the requirement to test at both cutoff levels would no longer be needed
to assure laboratory performance in this area.
For organizational clarity, the requirement in the first sentence
of current Section 2.7(f)(2) in Appendix A
[[Page 50559]]
to Part 26 that the laboratory must use GC/MS techniques for
confirmatory testing would be moved to proposed Sec. 26.167(e)(1)
[Quality control requirements for performing confirmatory drug tests],
which would establish quality control requirements for conducting
confirmatory drug tests.
The proposed rule would eliminate current Section 2.7(f)(3) in
Appendix A to Part 26, which requires HHS-certified laboratories to use
GC analysis of blood specimens in testing for alcohol, and the
confirmatory alcohol cutoff level in current Section 2.7(f)(1) in
Appendix A to Part 26. These provisions would be eliminated because the
proposed rule would no longer permit donors to request confirmatory
testing of a blood specimen for alcohol, as discussed with respect to
proposed Sec. 26.83(a).
In addition, the proposed rule would eliminate current Section
2.7(f)(4) in Appendix A to Part 26 for the same reasons discussed with
respect to current Section 2.7(e)(2) in Appendix A to Part 26.
Proposed Sec. 26.163(b)(1) would amend several of the cutoff
levels in current Section 2.7(f)(1) in Appendix A to Part 26 that the
HHS-certified laboratory uses to determine that a confirmatory drug
test result is positive. The proposed rule would increase the
confirmatory test cutoff levels for morphine and codeine to 2,000 ng/
mL. This proposed change in the cutoff levels for opiate metabolites
would substantially reduce the number of positive opiate test results
that are reported to MROs by HHS-certified laboratories that MROs
ultimately verify as negative and would be consistent with the opiate
cutoff levels contained in the HHS Guidelines.
Proposed Sec. 26.163(b)(1) would also amend two of the testing
procedures in current Section 2.7(f) in Appendix A to Part 26. The
proposed rule would amend Section 2.7(f)(5) in Appendix A to Part 26,
which requires the laboratory to test for 6-acetylmorphine (6-AM) if a
specimen tests positive for opiates on the initial drug test. The
proposed rule would require the HHS-certified laboratory to test for 6-
AM, if test results for morphine are at or above the 2,000 ng/mL opiate
cutoff levels, and establish a cutoff level of 10 ng/mL for determining
that a specimen is positive for 6-AM. In addition, proposed Sec.
26.163(b)(1) would add a requirement that a specimen must contain
amphetamine at a concentration equal to or greater than 200 ng/mL in
order for the HHS-certified laboratory to report to the MRO that the
specimen has yielded a positive test result for methamphetamine. These
proposed changes would be made for consistency with the related
provisions in the HHS Guidelines.
Proposed Sec. 26.163(b)(1) would update the terminology used in
current Section 2.7(f)(1) in Appendix A to Part 26. As discussed with
respect to proposed Sec. 26.5 [Definitions], the proposed paragraph
would replace the term, ``presumptive positive,'' with the phrase,
``positive on an initial drug test,'' to increase clarity in the
language of the rule.
Proposed Sec. 26.163(b)(2) would amend the second sentence of
current Section 2.7(f) in Appendix A to Part 26, which requires the
HHS-certified laboratory to document drug and drug metabolite
concentrations that exceed the linear region of the standard curve in
the laboratory record. The proposed rule would replace the current
sentence with a new paragraph that incorporates the related provision
from the HHS Guidelines. The HHS Guidelines permit the laboratory to
dilute an aliquot of the specimen to obtain an accurate quantitative
result when the concentration is above the upper limit of the linear
range. This proposed change would be made to meet Goal 1 of this
rulemaking, which is to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines.
Section 26.165 Testing Split Specimens and Retesting Single Specimens
A new Sec. 26.165 [Split specimens] would reorganize and amend the
requirements currently found in Sec. 26.24(f), and Section 2.7(i) and
(j) in Appendix A to Part 26 that are related to testing split
specimens and retesting specimens at HHS-certified laboratories. These
requirements would be presented together in a single section to make
them easier to locate in the proposed rule for organizational clarity.
The proposed section would also add several new requirements.
Proposed Sec. 26.165(a) [Split specimens] would combine and amend
current Sec. 26.24(f) and Section 2.7(j) in Appendix A to Part 26,
which establish requirements for HHS-certified laboratories when
testing split specimens. The proposed paragraph would use the terms,
``Bottle A'' and ``Bottle B,'' to refer to the primary and split
specimens, respectively, for consistency with the updated terminology
used throughout the proposed rule. The proposed paragraph would also
require specimen validity testing, consistent with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.165(a)(1) would retain the portions of current
Section 2.7(j) in Appendix A to Part 26 that require the HHS-certified
laboratory to analyze the primary specimen of a split specimen. The
current requirements that relate to licensee testing facilities would
be moved to Sec. 26.135 [Split specimens] in proposed Subpart F
[Licensee Testing Facilities] for organizational clarity. The proposed
paragraph would retain the requirement that the primary specimen
(Bottle A) must be subject to initial testing by the HHS-certified
laboratory, and confirmatory testing, if the specimen yields non-
negative results from initial testing. The proposed paragraph would
specify that the HHS-certified laboratory must conduct validity tests
on the specimen contained in Bottle A, as well as drug tests,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.165(a)(2) would retain the portion of the second
sentence of current Sec. 26.24(f) that requires the HHS-certified
laboratory to perform initial and confirmatory tests, if required, on
the specimen in Bottle A if any initial test results from a licensee
testing facility are non-negative. This requirement would be moved to
the proposed section for organizational clarity. In addition, the term,
``positive,'' in the current sentence would be replaced with the term,
``non-negative,'' to indicate that the HHS-certified laboratory must
conduct confirmatory testing of any specimens that yield non-negative
initial validity or drug test results at the licensee testing facility,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.165(a)(3) would retain the permission in the
second sentence of current Section 2.7(j) in Appendix A to Part 26 for
licensees and other entities to retain custody of the split specimen in
Bottle B or forward it with Bottle A to the HHS-certified laboratory
for storage until testing of Bottle A is completed. The proposed
paragraph would also retain the current permission for the specimen in
Bottle B to be discarded if test results from the HHS-certified
laboratory are negative.
Proposed Sec. 26.165(a)(4) would amend the requirements in current
Section 2.7(j) in Appendix A to Part 26, as they relate to donor
requests to test the specimen in Bottle B. The proposed
[[Page 50560]]
paragraph would add non-negative validity test results as a basis for a
donor request for testing the specimen in Bottle B, consistent with the
addition of requirements to conduct validity testing throughout the
proposed rule, as discussed with respect to proposed Sec.
26.31(d)(3)(i). The proposed paragraph would also add a requirement
that the donor must request testing of the Bottle B specimen within 3
business days after notification by the MRO that the specimen in Bottle
A has yielded non-negative test results. Since 1994, the HHS Guidelines
have allowed up to 72 hours for a donor to make this request, so the
proposed change would increase the consistency of Part 26 with the HHS
Guidelines.
The proposed paragraph would also require the donor to provide
written permission to the licensee or other entity for testing of the
specimen contained in Bottle B and clarify that only the donor may
authorize testing of Bottle B. At the public meetings discussed in
Section V, stakeholders indicated that the proposed requirement for a
written request from donors would impose a substantial logistical
burden on donors who may not be working on site when contacted by the
MRO. However, the NRC believes that the proposed requirement is
necessary to ensure that the donor's right to privacy and control of
the specimen is protected, consistent with Goal 7 of this rulemaking,
which is to protect the privacy and due process rights of individuals
who are subject to Part 26.
Proposed Sec. 26.165(a)(5) would require the HHS-certified
laboratory to forward Bottle B to a second HHS-certified laboratory for
testing within one business day of the donor's request for testing. The
proposed paragraph would eliminate the requirement in the fourth
sentence of current Section 2.7(j) in Appendix A to Part 26, which
requires that the split specimen must be forwarded to another HHS-
certified laboratory for testing on the same day of the donor request.
The proposed change would respond to stakeholder feedback during the
public meetings discussed in Section V. The stakeholders reported that
implementing the same-day requirement has often been difficult for a
number of reasons, including, for example, communication delays among
donors, MROs, the HHS-certified laboratories, and FFD program
personnel, particularly on weekends and holidays, and the time required
to identify a second laboratory with the appropriate capability to test
the split specimen, depending upon the nature of the non-negative test
result. The proposed change would alleviate some of these types of
logistical difficulties (e.g., logistical problems associated with
weekends and holidays) while continuing to provide the donor with
timely test results. Therefore, this proposed change would meet Goal 5
of this rulemaking, which is to improve Part 26 by eliminating or
modifying unnecessary requirements.
Proposed Sec. 26.165(a)(6) would retain the last sentence of
current Section 2.7(j) in Appendix A to Part 26, which requires the
second HHS-certified laboratory to provide quantitative test results
from Bottle B to the MRO, who would provide them to the donor. The
proposed paragraph would adopt the simpler language from the related
provision in the HHS Guidelines, consistent with Goal 6 of this
rulemaking, which is to improve clarity in the language of the rule.
Proposed Sec. 26.165(b) [Donor request to MRO for a retest of a
single specimen] would be added to permit donors to request retesting
of an aliquot from a single specimen, if the FFD program does not
follow split specimen procedures. The proposed paragraph would assure
that donors who are subject to a program that does not follow split
specimen procedures have the right to request additional testing. The
proposed change would be consistent with related provisions in the HHS
Guidelines. However, in order to have sufficient urine to support
retesting, the proposed paragraph would apply only if the donor had
submitted a specimen of 30 mL or more. Specimens that the HHS-certified
laboratory determines to be invalid would not be eligible for retesting
because of the risk of damage to laboratory equipment that some invalid
specimens may pose and because retesting the specimen would not provide
useful information. The proposed procedures for requesting and
conducting the retest of a single specimen would be consistent with
those for requesting and conducting tests on the specimen in Bottle B
of a split specimen.
Proposed Sec. 26.165(c) [Retesting a specimen for drugs] would
amend current Section 2.7(i) in Appendix A to Part 26, which specifies
that retesting of a specimen is not subject to cutoff requirements. The
proposed paragraph would update and expand current requirements for
retesting a single specimen or Bottle B of a split specimen for drugs
and drug metabolites to be consistent with the related provisions in
the HHS Guidelines, as follows:
Proposed Sec. 26.165(c)(1) would be added to require the second
HHS-certified laboratory to use the laboratory's standard confirmatory
test for the drug or drug metabolite for which the specimen tested
positive at the first laboratory. Initial tests, and tests for other
drugs or drug metabolites, would not be performed, consistent with the
related requirements in the HHS Guidelines.
Proposed Sec. 26.165(c)(2) would amend current Section 2.7(i) in
Appendix A to Part 26, which specifies that retesting of a specimen is
not subject to cutoff requirements. The proposed paragraph would retain
the requirement for the second HHS-certified laboratory to provide data
sufficient to confirm the presence of the drug(s) or drug metabolite(s)
and add permission to test the specimen down to the assay's LOD. Adding
permission to test down to the assay's LOD would be consistent with the
related requirement in the HHS Guidelines and would ensure that the
second laboratory's testing is as sensitive to the presence of the
drug(s) or drug metabolite(s) as scientifically and legally defensible.
Proposed Sec. 26.165(c)(3) would be added to require the second
laboratory to attempt to determine the reason if retesting fails to
confirm the presence of the drug(s) or drug metabolite(s) that was
identified by the first HHS-certified laboratory. The proposed
paragraph would require the second laboratory to conduct specimen
validity testing if the second laboratory fails to reconfirm the first
laboratory's findings, consistent with the related requirements in the
HHS Guidelines.
Proposed Sec. 26.165(c)(4) would retain the requirement in the
last sentence of current Section 2.7(j) in Appendix A to Part 26 that
requires the second laboratory to report the test results to the MRO.
The proposed rule would extend this requirement to retesting of a
single specimen, consistent with the explicit permission added in
proposed Sec. 26.165(b) for a donor to request retesting of a single
specimen, if the FFD program does not follow split specimen procedures.
The proposed requirement would be consistent with the related
requirements in the HHS Guidelines.
Proposed Sec. 26.165(d) [Retesting a specimen for adulterants] and
(e) [Retesting a specimen for substitution] would be added to
incorporate related requirements in the HHS Guidelines for performing
retests for adulterants and substituted specimens at a second HHS-
certified laboratory. Retesting for adulterants would be limited to
conducting confirmatory testing only for the adulterant(s) identified
by the first laboratory. Retesting for specimen substitution would be
limited to
[[Page 50561]]
conducting confirmatory testing only for creatinine and specific
gravity. These proposed limitations would be consistent with
limitations on retesting specimens for drugs and drug metabolites.
Proposed Sec. 26.165(f) [Management actions and sanctions] would
be added to specify the actions that licensees and other entities must
take when a donor requests a retest of a single specimen or testing of
Bottle B of a split specimen. The proposed paragraph would respond to
stakeholder comments at the public meetings discussed in Section V. The
stakeholders noted that the current rule does not address required
management actions when an individual has had a confirmed non-negative
test result and requests a retest of a single specimen or Bottle B of a
split specimen. Therefore, the proposed paragraph would be added to
establish such requirements.
Proposed Sec. 26.165(f)(1) would be added to address circumstances
in which the MRO has confirmed a non-negative test result from the HHS-
certified laboratory as a violation of the licensee's or other entity's
FFD policy and the donor requests a retest of a single specimen or
testing of the specimen in Bottle B. The proposed paragraph would
require the licensee or other entity to take the same actions in
response to the confirmed non-negative test result(s) from the first
HHS-certified laboratory as the actions that licensees and other
entities would be permitted to take under proposed Sec. 26.75(i) in
response to a positive drug test result for marijuana or cocaine from
initial testing at a licensee testing facility. That is, proposed Sec.
26.165(f) would require the licensee or other entity to
administratively withdraw the donor's authorization until the test
results from the second HHS-certified laboratory have been reported to
and reviewed by the MRO. If the test results from the second laboratory
confirm any non-negative test results from the first HHS-certified
laboratory, the proposed paragraph would require the licensee or other
entity to impose the appropriate sanctions that are specified in
proposed Subpart D [Management actions and sanctions] for the non-
negative test results that were confirmed by the second laboratory. If
the test results from the second laboratory do not confirm any non-
negative test results, the proposed rule would (1) prohibit the
licensee or other entity from imposing any sanctions on the individual;
(2) require the licensee or other entity to eliminate any records of
the first confirmed non-negative test results; and (3) require the
licensee or other entity to inform the donor, in writing, that the
records have been expunged and that he or she need not disclose the
temporary administrative action to any other licensee or entity. These
proposed requirements would protect public health and safety and the
common defense and security by ensuring that an individual whose
fitness for duty is questionable does not perform any duties or have
the types of access that require the individual to be subject to this
part, while protecting the donor's right to due process.
Proposed Sec. 26.165(f)(2) would be added to address the unlikely
circumstances in which a donor requests retesting of a single specimen
or testing Bottle B of a split specimen, but the testing cannot be
performed because the single specimen or Bottle B is no longer
available due to causes that are outside of the donor's control. These
causes could include, for example, an insufficient quantity of urine in
the single specimen to permit retesting, either Bottle B or the
original single specimen is lost in transit to the second HHS-certified
laboratory, or Bottle B has been misplaced.
The proposed paragraph would require the MRO to cancel the original
test result, prohibit the licensee or other entity from imposing any
sanctions on the donor, and require the licensee or other entity to
ensure that any records are expunged that could link the donor to the
original non-negative test result and the administrative action
required under proposed Sec. 26.165(f)(1). The proposed paragraph
would require the licensee or other entity to document that the test
was performed and cancelled, if the original specimen was collected for
random, for-cause, or post-event testing. However, the MRO would direct
the licensee or other entity to collect another specimen from the donor
as soon as reasonably practical, if the original specimen was collected
for pre-access or followup testing. The proposed paragraph would not
require a second collection for a random test because a second
collection could not satisfy the requirements for random testing [i.e.,
the donor would not have the same probability of being selected for
testing as all other donors who are subject to the FFD program, as
required under proposed Sec. 26.31(c)(iv)]. The proposed rule also
would not require a second collection when the original test was
conducted for cause or post event because test results from a second
collection could not accurately measure the presence of drugs or drug
metabolites under the conditions that required the original collection
due to the passage of time. The proposed paragraph would require a
second collection as soon as reasonably practical for pre-access and
followup testing because other provisions of the proposed regulation
(see proposed Subpart C [Granting and Maintaining Authorization])
require negative test results in order for the licensee or other entity
to grant or maintain the donor's authorization.
The last sentence of proposed Sec. 26.165(f)(2) would require the
licensee or other entity to impose the appropriate sanctions, as
specified in proposed Subpart D [Management actions and sanctions], if
the results of testing the specimen from a second collection are non-
negative and confirmed by the MRO to be an FFD policy violation.
However, the proposed rule would prohibit the licensee or other entity
from considering the results of testing the original specimen when
imposing sanctions because the donor was (inadvertently) denied his or
her right to due process in this case.
The new requirements in proposed Sec. 26.165(f) would be generally
consistent with related requirements in the HHS Guidelines. The
differences from the HHS Guidelines' requirements in the proposed rule
would be variations in the terminology used to adapt the language for
the NRC's purposes and the addition of cross-references to other
portions of the proposed rule.
Section 26.167 Quality Assurance and Quality Control
Proposed Sec. 26.167 [Quality assurance and quality control] would
update current Section 2.8 in Appendix A to Part 26, which establishes
quality assurance and quality control requirements for drug testing at
HHS-certified laboratories. The proposed section would provide more
detailed requirements for the quality assurance and quality control
programs of HHS-certified laboratories for consistency with related
provisions in the HHS Guidelines, and add new requirements for validity
testing, consistent with the addition of requirements to conduct
validity testing throughout the proposed rule, as discussed with
respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.167(a) [Quality assurance program] would amend
and combine current Section 2.8(a) and the last two sentences of
Section 2.8(d) in Appendix A to Part 26, which require HHS-certified
laboratories and licensee testing facilities to have quality assurance
programs. For increased clarity in the language of the rule, the
proposed rule would replace the term, ``specimen acquisition,'' with
the term, ``specimen accessioning,'' in the first
[[Page 50562]]
sentence of current Section 2.8(a), which is the more accurate term.
The proposed rule would also add a requirement for the quality
assurance program to encompass the certification of calibrators and
controls to ensure that calibrators and controls are accurate, which
would be consistent with the related provision in the HHS Guidelines.
In addition, the proposed rule would move to proposed Sec.
26.167(a) and amend the requirements in the last two sentences of
current Section 2.8(d) in Appendix A to Part 26, which require that the
linearity and precision of testing methods used must be periodically
documented as well as the procedures to ensure that carryover does not
contaminate a donor's specimen. The proposed rule would update these
requirements for consistency with the HHS Guidelines and require that
(1) the performance characteristics (e.g., accuracy, precision, LOD,
limit of quantitation (LOQ), specificity) for each test must be
validated and documented; (2) validation of procedures must document
that carryover does not affect the donor's specimen results, and (3)
the laboratory must periodically re-verify the analytical procedures.
These requirements would be moved to proposed Sec. 26.167(a) for
organizational clarity because they are aspects of the laboratory's
quality assurance program.
The requirements in current Section 2.8(a) in Appendix A to Part 26
that apply to licensee testing facilities would be moved to Sec.
26.137(a) [Quality assurance program] in proposed Subpart F [Licensee
Testing Facilities] for organizational clarity. The second sentence of
current 2.8(a) would be retained in proposed Sec. 26.167(a).
The quality control requirements for initial tests at licensee
testing facilities in current Section 2.8(b) in Appendix A to Part 26
would be relocated to Sec. 26.137 [Quality assurance and quality
control] in proposed Subpart F [Licensee Testing Facilities]. The
proposed change would be made for organizational clarity.
Proposed Sec. 26.167(b) [Calibrators and controls required] would
retain the portions of current Section 2.8(c) and (d) in Appendix A to
Part 26 that require HHS-certified laboratories to use appropriate
calibrators and controls for initial and confirmatory drug testing. The
proposed rule would add a requirement to include appropriate
calibrators and controls for initial and confirmatory validity testing,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i). The more detailed requirements for
calibrators and controls in current Section 2.8(c) and (d) would be
amended and presented in this section of the proposed rule in separate
paragraphs that address each type of test to be performed by the HHS-
certified laboratory. The proposed changes would be made for increased
consistency with the HHS Guidelines and to improve the organizational
clarity of the proposed rule.
Proposed Sec. 26.167(c) [Quality control requirements for
performing initial and confirmatory validity tests] would be added to
establish quality control requirements for performing initial and
confirmatory validity tests at an HHS-certified laboratory. The quality
control requirements for validity tests in this proposed paragraph
would incorporate the related provisions of the HHS Guidelines.
Proposed Sec. 26.167(c)(1) [Requirements for performing creatinine
tests] would be added to require HHS-certified laboratories to measure
creatinine concentration to 1 decimal place on initial and confirmatory
creatinine tests and establish requirements for the quality control
samples to be used in initial and confirmatory tests for creatinine
concentration.
Proposed Sec. 26.167(c)(2) [Requirements for performing specific
gravity tests] would be added to establish the required characteristics
of the refractometers used by HHS-certified laboratories to measure
specific gravity and the characteristics of the quality control samples
to be used for initial and confirmatory tests for a specimen's specific
gravity.
Proposed Sec. 26.167(c)(3) [Requirements for performing pH tests]
would be added to establish quality control requirements for performing
initial and confirmatory pH tests. Proposed Sec. 26.167(c)(3)(i)-
(c)(3)(v) would specify the required calibrators and controls for pH
testing, based upon the type of testing instrument used and whether a
pH validity screening test has been performed.
The proposed rule would add three additional paragraphs related to
quality control of initial and confirmatory validity testing: proposed
Sec. 26.167(c)(4) [Requirements for performing oxidizing adulterant
tests], proposed Sec. 26.167(c)(5) [Requirements for performing
nitrite tests], and proposed Sec. 26.167(c)(6) [Requirements for
performing ``other'' adulterant tests]. The proposed paragraphs would
establish quality control requirements for performing initial and
confirmatory tests for oxidizing adulterants, among which nitrites are
one example, and for ``other'' adulterants.
Proposed Sec. 26.167(d) [Quality control requirements for initial
drug tests] would amend and combine portions of current Sections 2.7(d)
and (e)(1), and 2.8(c) in Appendix A to Part 26, which establish
quality control requirements for performing initial tests for drugs and
drug metabolites at HHS-certified laboratories. The proposed paragraph
would group together the current requirements that are dispersed
throughout the rule to meet Goal 6 of this rulemaking, which is to
improve clarity in the organization and language of the rule. In
addition, the proposed rule would amend a number of the current
requirements, as follows:
Proposed Sec. 26.167(d)(1) would amend the first sentence of
current Section 2.7(e)(1) in Appendix A to Part 26 but retain the
intent of the current provision as it applies to HHS-certified
laboratories. The current and proposed paragraphs require laboratories
to use only immunoassay tests that meet the requirements of the Food
and Drug Administration for commercial distribution. The requirements
in the current paragraph related to initial drug testing at licensee
testing facilities would be moved to Sec. 26.137(e)(1) of proposed
Subpart F [Licensee Testing Facilities] to improve organizational
clarity in the rule.
Proposed Sec. 26.167(d)(2) would permit HHS-certified laboratories
to conduct multiple tests of a single specimen for the same drug or
drug class. The requirements in this paragraph would be consistent with
a similar provision in the HHS Guidelines and would be added to meet
Goal 1 of this rulemaking, which is to update and enhance the
consistency of Part 26 with advances in other relevant Federal rules
and guidelines.
Proposed Sec. 26.167(d)(3)(i)-(d)(3)(vi) would update current
Section 2.8(c) in Appendix A to Part 26, which requires HHS-certified
laboratories to include quality control samples in each analytical run
of specimens for initial drug testing. Proposed Sec. 26.167(d)(3)(i)-
(d)(3)(vi) would specify the number and characteristics of the quality
control samples to be included in each analytical run of specimens.
These proposed requirements would be the same as those contained in
proposed Sec. 26.137(e)(6) and (e)(7) for initial drug tests at
licensee testing facilities and would be added for consistency with the
related provisions in the HHS Guidelines.
Proposed Sec. 26.167(e) [Quality control requirements for
performing confirmatory drug tests] would update and combine portions
of current Sections 2.7(f)(2) and 2.8(d) in
[[Page 50563]]
Appendix A to Part 26, which address quality control requirements for
performing confirmatory drug tests. In general, the proposed changes to
the current requirements would be made for organizational clarity in
the proposed rule and to incorporate the related provisions in the HHS
Guidelines.
Proposed Sec. 26.167(e)(1) would amend current Section 2.7(f)(2)
in Appendix A to Part 26, which requires that confirmatory drug tests
must be performed using gas chromatography/mass spectrometry (GC/MS).
The proposed paragraph would permit HHS-certified laboratories to use
other techniques for confirmatory drug testing that the HHS Guidelines
approve for use in Federal workplace drug testing programs.
Proposed Sec. 26.167(e)(2)(i)-(e)(2)(iv) would amend the
requirements for quality control samples in current Section 2.8(d) in
Appendix A to Part 26. Proposed Sec. 26.167(e)(2)(i) and (e)(2)(ii)
would retain the current requirements for laboratories to include blank
samples and samples that contain known standards in each analytical
run. The proposed requirements would adopt the simpler language from
the related provisions in the HHS Guidelines to improve clarity in the
language of the rule. For consistency with the related requirements in
the HHS Guidelines, the proposed paragraph would provide more detailed
requirements for ``positive controls with the drug or metabolite at or
near the threshold'' in current Section 2.8(d)(1) in Appendix A to Part
26. The proposed rule would require, in proposed Sec.
26.167(e)(2)(iii), at least one control fortified with a drug or drug
metabolite targeted at 25 percent above the cutoff and, in proposed
Sec. 26.167(e)(2)(iv), at least one calibrator or control that is
targeted at or below 40 percent of the cutoff.
Proposed Sec. 26.167(f) [Blind performance testing] would amend
current Section 2.8(e) in Appendix A to Part 26, which establishes
requirements for licensees and other entities to conduct blind
performance testing of HHS-certified laboratories, as follows:
Proposed Sec. 26.167(f)(1) would amend the portion of current
Section 2.8(e)(2) in Appendix A to Part 26 that establishes the
percentages and numbers of blind performance test samples that
licensees and other entities must submit to the HHS-certified
laboratory during the first 90 days of any initial contract with the
HHS-certified laboratory. The proposed paragraph would decrease the
percentage of blind performance test samples that licensees and other
entities would submit to the HHS-certified laboratory during the
initial 90-day period of any contract (not including rewritten or
renewed contracts). Specifically, the proposed rule would reduce the
percentage from 50 percent to 20 percent of the total number of
specimens submitted in the 90-day period, up to a maximum of 100 blind
samples, rather than a maximum of 500 samples as specified in the
current rule. This proposed decrease in the blind performance testing
rate would increase the consistency of Part 26 requirements with the
related provisions in the HHS Guidelines. In addition, since the NRC
published the current rule, the number and size of Federal agencies who
conduct drug testing has substantially increased, and these agencies
are also required to submit blind performance test samples under the
HHS Guidelines. As a result, the burden on Part 26 programs to conduct
performance tests of the HHS-certified laboratories may be reduced
without affecting the likelihood that errors in testing will be
detected.
The proposed rule would also add a requirement for licensees and
other entities to submit a minimum of 30 blind performance test
specimens in the 90-day period. This proposed minimum would be
established to address Part 26 programs who submit only a small number
of specimens to HHS-certified laboratories for testing each quarter.
For example, for a very small program, 20 percent of the number of
specimens submitted in the 90-day period could be less than one blind
performance test sample. Establishing a minimum number of samples would
provide assurance that the HHS-certified laboratories used by these
Part 26 programs are providing accurate test results.
Proposed Sec. 26.167(f)(2) would amend the portion of current
Section 2.8(e)(2) in Appendix A to Part 26 that addresses ongoing blind
performance testing after the first 90 days of an initial contract with
an HHS-certified laboratory. The proposed rule would decrease the rate
at which licensees and other entities must submit blind performance
test samples to an HHS-certified laboratory in each quarter after the
initial 90-day period from 10 percent in the current rule to 1 percent,
or a total of 10 samples, whichever is greater. The proposed rule would
also decrease the maximum number of samples to be submitted per quarter
from 250 to 100 samples. The rationale for these proposed changes would
be the same as discussed with respect to proposed Sec. 26.167(f)(1).
Proposed Sec. 26.167(f)(3) would decrease the proportion of spiked
blind samples that licensees and other entities would submit each
quarter from 20 percent in Section 2.8(e)(3) in Appendix A to Part 26
to 15 percent. The proposed rule would retain the current requirement
that samples must be spiked with only the drugs that are included in
the licensee's or other entity's panel of drugs. The proposed rule
would add a requirement that the spiked samples must be spiked to
between 60-80 percent of the initial cutoff levels used by the licensee
or other entity to be consistent with related requirements in the HHS
Guidelines. In addition, the proposed rule would add a requirement for
licensees and other entities to submit samples that meet the criteria
for adulteration, dilution, and substitution, in order to challenge the
laboratory's validity testing. Licensees and other entities would be
required to submit blind samples each quarter that are appropriately
adulterated, diluted, or substituted, in the amount of 5 percent of the
specimens submitted that quarter or at least 3 samples per quarter (one
each that is adulterated, diluted, or substituted), whichever is
greater. This proposed change would be made for consistency with the
addition of requirements to conduct validity testing throughout the
proposed rule, as discussed with respect to proposed Sec.
26.31(d)(3)(i), and would be necessary to challenge the accuracy of the
HHS-certified laboratory's specimen validity testing.
Proposed Sec. 26.167(f)(4) would retain current Section 2.8(e)(3)
in Appendix A to Part 26, which requires that 80 percent of the blind
samples submitted by the licensee or other entity each quarter to the
HHS-certified laboratory must be ``blank'' (i.e., certified to contain
no drugs or drug metabolites).
Proposed Sec. 26.167(f)(5) would be added to establish detailed
requirements for the blind performance test samples that licensees and
other entities must submit to the HHS-certified laboratories. The
proposed rule would require the supplier of the blind samples to
certify and provide an expiration date for each sample. Proposed Sec.
26.167(f)(i) and (f)(ii) would specify the characteristics of the
samples that licensees and other entities would be required to use to
challenge the HHS-certified laboratory's drug and validity testing,
respectively. The proposed quality control requirements would be
necessary to ensure the effectiveness of the blind performance testing
process and would incorporate the related requirements in the HHS
Guidelines.
Proposed Sec. 26.167(g) [Errors in testing] would amend current
Section 2.8(e)(4)-(e)(6) in Appendix A to Part 26, which establishes
requirements for licensees, other entities, and HHS-
[[Page 50564]]
certified laboratories related to unsatisfactory performance, including
false positive and false negative test results, by the HHS-certified
laboratory. The proposed paragraph would require the licensee or other
entity to ensure that the HHS-certified laboratory investigates any
conditions that may adversely reflect on the testing process. Notably,
the proposed rule would no longer require the licensee to perform the
investigation, but rather to ``ensure'' that the laboratory completes
an investigation. This change is proposed because licensees and other
entities do not typically retain personnel with the expertise required
to investigate the complex technologies and processes involved in
testing at the HHS-certified laboratories. The requirement for
documentation of the investigation, which currently appears in Section
2.8(e)(4) in Appendix A to Part 26, would be moved to Sec.
26.215(b)(8) in proposed Subpart J [Recordkeeping and Reporting
Requirements] for organizational clarity.
Proposed Sec. 26.167(g)(1) would explicitly state the requirements
that are implied in current Section 2.8(e)(4) in Appendix A to Part 26,
that the investigation must identify the root cause(s) of any
unsatisfactory performance and the HHS-certified laboratory must take
corrective actions. The proposed rule would expand these requirements
to include the licensee or other entity, as well as the HHS-certified
laboratory, depending upon the causes identified and the extent to
which the causes are within each entity's control. The proposed
requirement would be added to recognize that some testing errors are
not attributable to the HHS-certified laboratory.
Proposed Sec. 26.167(g)(2) would amend current Section 2.8(e)(5)
in Appendix A to Part 26, which requires the licensee to notify the NRC
if a false positive error occurs on a blind performance test sample and
the error is determined to be administrative. The proposed paragraph
would require the licensee or other entity, and the HHS-certified
laboratory, to take corrective actions for any false positive errors in
blind performance testing, in response to the findings of the
investigation that would be required in proposed Sec. 26.167(i). The
proposed rule would continue to authorize licensees and other entities
to require the laboratory to review and re-analyze previously tested
specimens, if the investigation indicates that the error could have
been systematic. The proposed rule would also delete reference to
administrative errors, which appears in current Section 2.8(e)(5), so
that any type of errors would fall under the requirements of the
proposed paragraph. The reporting requirement in current Section
2.8(e)(5) would be moved to Sec. 26.219(c)(2) in proposed Subpart J
[Recordkeeping and Reporting Requirements] for organizational clarity.
Proposed Sec. 26.167(g)(3) would amend current Section 2.8(e)(6)
in Appendix A to Part 26, which addresses false positive errors
resulting from methodological errors by the laboratory. The proposed
rule would incorporate reference to validity testing, consistent with
the addition of requirements to conduct validity testing throughout the
proposed rule, as previously discussed with respect to Sec.
26.31(d)(3)(i). The proposed rule would also replace the reference to
the individual who is responsible for day-to-day management of the
laboratory with a requirement for the laboratory's certifying scientist
to document the retesting of specimens that may be required under this
paragraph. This proposed change would be made for consistency with the
related provision of the HHS Guidelines. The proposed paragraph would
delete the last sentence of the current paragraph because it addresses
the responsibilities of the HHS and is not relevant to the NRC or the
licensees and other entities who are subject to Part 26. The proposed
paragraph would retain the other provisions of current Section
2.8(e)(6), but adopt the simpler language of the related provision in
the HHS Guidelines for increased clarity in the language of the
proposed rule.
Proposed Sec. 26.167(h) [Accuracy] would retain current Section
2.7(o)(3)(i) in Appendix A to Part 26 with minor editorial revisions.
The current paragraph would be relocated to proposed Sec. 26.167
because it is related to quality control of the HHS-certified
laboratory's drug testing processes. These proposed changes would be
made to meet Goal 6 of this rulemaking, which is to improve clarity in
the organization and language of the rule.
Proposed Sec. 26.167(i) [Calibrators and controls] would update
current Section 2.7(o)(2) in Appendix A to Part 26. At the time the
original paragraph was written, most laboratories prepared their own
standards and controls. In the ensuing years, the number and variety of
sources for materials used in performance testing has increased. The
proposed paragraph would update current requirements to refer to
several of the alternatives, including, but not limited to pure drug
reference materials, stock standard solutions from other laboratories,
and standard solutions obtained from commercial manufacturers. The
proposed requirements in this paragraph incorporate the related
requirements in the HHS Guidelines and would meet Goal 1 of this
rulemaking, which is to update and enhance the consistency of Part 26
with advances in other relevant Federal rules and guidelines. The
labeling requirements in the second sentence of current Section
2.7(o)(2) would be retained.
Section 26.169 Reporting Results
Proposed Sec. 26.169 [Reporting results] would amend current
Section 2.7(g) in Appendix A to Part 26, which contains requirements
for HHS-certified laboratories' reporting of test results to the
licensee's or other entity's MRO. The proposed rule would update the
current requirements for consistency with the HHS Guidelines. In
addition, the proposed rule would add requirements for reporting the
results of validity testing, consistent with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.169(a) would amend current Section 2.7(g)(1) in
Appendix A to Part 26, which establishes a time-limit on the HHS-
certified laboratory's reporting of test results to the MRO and
requirements for the processing and content of the report. The proposed
rule would retain the requirement for the laboratory to report results
to the MRO within 5 business days of receiving the specimen at the
laboratory. Under the proposed rule, the HHS-certified laboratory's
``certifying scientist,'' rather than the laboratory's ``responsible
individual,'' would certify the test results. This proposed change
would be made for consistency with the updated term used to refer to
this individual, as discussed with respect to proposed Sec. 26.155(b).
The proposed rule would add a reference to validity test results,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i). The proposed rule would delete the
current prohibition on reporting test results for any specimen in a
group of specimens sent to the laboratory by the licensee or other
entity until the laboratory completes testing of all of the specimens
in the group. The prohibition in the current rule was based upon a
concern for maintaining control of specimen identity. However, new
technologies for identifying specimens and aliquots (such as bar codes
on specimen labels matched to bar codes on aliquots and the associated
custody-and-control forms) have reduced the likelihood that specimen
[[Page 50565]]
identity may be lost, and, therefore, have substantially reduced the
need for the requirement in the current rule.
Proposed Sec. 26.169(b) would amend current Section 2.7(g)(2) in
Appendix A to Part 26, which establishes requirements for the manner in
which HHS-certified laboratories and licensee testing facilities must
report test results to licensee management. The requirements in the
current paragraph that are related to reporting test results from the
licensee testing facility would be moved to Sec. 26.139(a) of proposed
Subpart F [Licensee Testing Facilities] for organizational clarity. The
proposed paragraph would delete the current reference to ``special
processing'' and replace it with reference to validity test results,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i). In addition, the proposed rule would
make minor changes in terminology, such as referring to a ``drug or
drug metabolite,'' rather than a ``substance,'' for clarity in the rule
language.
Proposed Sec. 26.169(c) would amend portions of current Section
2.7(f)(2) in Appendix A to Part 26 by deleting the requirement for the
HHS-certified laboratory to conduct tests for drugs and drug
metabolites using both the cutoff levels specified in this part and any
more stringent cutoff levels specified by the FFD program. Under the
proposed rule, if the FFD program specifies cutoff levels that are more
stringent than those specified in this part, the laboratory need only
conduct testing using those more stringent cutoff levels, and need only
report results from those tests to the MRO. This proposed change would
be made for the reasons discussed with respect to proposed Sec.
26.31(d)(1)(i)(D).
Proposed Sec. 26.169(d) would be added to establish requirements
for the laboratory's reporting of the results of validity testing.
Under the proposed rule, HHS-certified laboratories would be required
to report to the MRO quantitative results for any specimen that is
found to be dilute, adulterated, or substituted. The MRO would be
prohibited from reporting the quantitative validity test results to the
licensee or other entity, except as permitted with a signed consent
from the donor under proposed Sec. 26.37(b). The proposed paragraph
also would require the HHS-certified laboratory to contact the
licensee's or other entity's MRO when the laboratory concludes that a
specimen is invalid, and consult with the MRO to determine whether
additional testing by a second HHS-certified laboratory would be useful
in being able to report an adulterated or substituted test result. The
proposed rule would permit the laboratory's contact with the MRO to
occur using electronic means, such as telephone, fax, and e-mail. These
proposed reporting requirements would be added for consistency with the
related provisions in the HHS Guidelines.
Proposed Sec. 26.169(e) would be added to require the HHS-
certified laboratory to report more than one test result for a single
specimen, if the laboratory obtains more than one non-negative test
result from testing of the specimen. This proposed provision would
require the laboratory to report any drug-positive test results, as
well as any non-negative validity test results from the same specimen.
This proposed change is necessary because sanctions for the different
test results would differ under proposed Sec. 26.75 [Sanctions].
Reporting multiple test results for a single specimen would be
consistent with related requirements in the HHS Guidelines.
Proposed Sec. 26.169(f) would update current Section 2.7(g)(3) in
Appendix A to Part 26, which permits the MRO routinely to obtain
quantitative test results from the HHS-certified laboratory.
Specifically, the proposed rule would revise the first sentence of
current Section 2.7(g)(3) by stating that the HHS-certified laboratory
shall provide quantitative test results to the MRO upon request. The
proposed paragraph would clarify the current requirement by stating
that the MRO's request may be either a general request covering all
such results or a specific case-by-case request. The proposed
clarification would be necessary because the current sentence has
raised questions from HHS-certified laboratories to the HHS. In
addition, the proposed rule would add the third sentence of proposed
Sec. 26.169(f) to clarify requirements for reporting drug test results
when the concentration of a drug, metabolite, or adulterant exceeds the
linear range of the standard curve. The proposed rule would also delete
the existing reference to test results from blood specimens for the
reasons discussed with respect to proposed Sec. 26.83(a). Disclosure
of quantitative test results to licensees and other entities would
continue to be subject to the requirements in proposed Sec. 26.37(b).
The proposed changes to this paragraph would be consistent with the
related provisions in the HHS Guidelines.
Proposed Sec. 26.169(g) would require HHS-certified laboratories
to report to the MRO quantitative values for confirmatory opiate test
results for morphine or codeine that are equal to or greater than
15,000 ng/mL. The proposed rule would add this requirement for
consistency with the related provision in the HHS Guidelines and
because the MRO would not be required to perform an assessment for
clinical signs of opiate abuse in this instance, as discussed with
respect to proposed Sec. 26.185(f)(1).
Proposed Sec. 26.169(h) would amend current Section 2.7(g)(4) in
Appendix A to Part 26, which establishes requirements for the
electronic transmission of test results from the HHS-certified
laboratory to the MRO. Specifically, the proposed rule would clarify
that the licensee or other entity is responsible for assuring the
security of data transmissions from the laboratory to the MRO, rather
than only the HHS-certified laboratory, as specified in the current
requirement. The proposed change would respond to stakeholder comments
at the public meetings discussed in Section V. The stakeholders
accurately noted that licensees and other entities are responsible to
the NRC for ensuring the security of their HHS-certified laboratories'
data storage and transmission systems through their contracts with and
audits of the laboratories. The proposed revision would more accurately
characterize these relationships without changing the intent of the
current provision.
Proposed Sec. 26.169(i) would update current Section 2.7(g)(5) in
Appendix A to Part 26, which establishes requirements for transmitting
chain-of-custody documentation with test results to the MRO. The
proposed rule would permit HHS-laboratories to use various means to
transmit test results to the MRO, including transmittal of a computer-
generated electronic report for negative test results. However, for
non-negative test results, the proposed rule would require the
laboratory to transmit a legible image or copy of the completed
custody-and-control form to the MRO. The proposed change would be made
for consistency with the related provision in the HHS Guidelines.
Proposed Sec. 26.169(j) would further amend current Section
2.7(g)(5) in Appendix A to Part 26. The proposed paragraph would
continue to require that the HHS-certified laboratory must retain the
original custody-and-control form for any non-negative specimens.
However, the proposed paragraph would assign responsibility for
certifying the test results to the laboratory's certifying scientist,
rather than to ``the individual responsible for day-to-day management
of the laboratory or the individual responsible for attesting to the
validity of the test
[[Page 50566]]
reports.'' The proposed change would be made for consistency with the
updated terminology used to refer to this individual in the HHS
Guidelines, as discussed with respect to proposed Sec. 26.155(b).
Proposed Sec. 26.169(k) would combine and amend current Section
2.7(g)(6) and (g)(7) in Appendix A to Part 26, which require the
laboratory to submit a monthly statistical summary of drug test results
to the licensee or other entity. The proposed rule would reduce the
required frequency of the statistical summary report from monthly to
annually in order to reduce the burden on licensees, other entities,
and their laboratories. The proposed requirement for annual reporting
would make the reporting time consistent with the NRC's need for the
information as it relates to the NRC's inspection schedule and the
annual FFD program performance report that would be required under
proposed Sec. 26.217 [Fitness-for-duty program performance data], for
the reasons discussed with respect to that section. The proposed rule
would also delete the existing reference to blood specimens because the
option for donors to request blood testing for alcohol would be
eliminated from the proposed rule, as discussed with respect to
proposed Sec. 26.83(a). The proposed rule would also delete the
requirement to report drug test results at the cutoff levels specified
in this part, if the FFD program uses more stringent cutoff levels, for
the reasons discussed with respect to proposed Sec. 26.169(c). The
proposed rule would add a requirement to report initial and
confirmatory test results for additional drugs (if the FFD program
tests for additional drugs), as well as a requirement to report the
number of specimens with confirmed positive 6-acetylmorphine (6-AM)
test results. (The proposed rule would include testing for 6-AM,
because the presence of 6-AM in a specimen uniquely identifies heroin
use.) In addition, the proposed rule would add requirements to report
the results of validity testing. These proposed changes would be made
to conform the laboratory's annual summary report to other changes in
the proposed rule, as discussed with respect to proposed Sec. Sec.
26.217(b)(2), Sec. 26.185(f)(1), and 26.31(d)(3)(i).
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Section 26.181 Purpose
Proposed Sec. 26.181 [Purpose] would describe the purpose of
Subpart H, which is to establish requirements for MRO reviews of non-
negative confirmatory drug test results and for making determinations
of fitness. This proposed section would provide an overview of the
contents of the proposed subpart, consistent with Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Section 26.183 Medical review officer
Proposed Sec. 26.183 [Medical review officer] would be added to
present requirements related to the qualifications, relationships,
staff, and responsibilities of the MRO to meet Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule, by grouping these requirements together in a
single section.
Proposed Sec. 26.183(a) [Qualifications] would combine and amend
the requirements in current Sec. 26.3 [Definitions] and Section 1.2 of
Appendix A to Part 26, as well as portions of current Section 2.9(b) in
Appendix A to Part 26. The proposed rule would reorganize the current
requirements to eliminate redundancies and group together in one
paragraph the related provisions in the current rule to meet Goal 6 of
this rulemaking, which is to improve clarity in the organization and
language of the rule.
The proposed paragraph would amend portions of the current
requirements related to MRO qualifications. The proposed paragraph
would continue to provide that the MRO must be a licensed physician,
but would clarify that the MRO may hold either a Doctor of Medicine or
Doctor of Osteopathy degree for consistency with the related
regulations of other Federal agencies. The proposed rule would add a
requirement that the MRO must be knowledgeable of Part 26 and the FFD
policies and procedures of the licensees and other entities for whom
the MRO provides services. The proposed requirements of this part, and
the policies and procedures of various Part 26 FFD programs, may differ
from those of other workplace drug and alcohol testing programs for
which an MRO provides services. This proposed provision would ensure
that an MRO is able to perform his or her function appropriately under
this part. In addition, the proposed rule would add a requirement that,
within 2 years following the date on which this rule is published in
the Federal Register, the MRO must pass an MRO certification
examination. The proposed requirement would increase consistency in the
performance of the MRO function among FFD programs, given that
licensees and other entities would be permitted to accept test results
and the results of determinations of fitness conducted by other
licensees and entities who are subject to the rule. The 2-year
implementation date would provide MROs who are not currently certified
with an opportunity to pass the required examination. With the
exception of the first sentence of this proposed paragraph, which
specifically relates to the MRO function under Part 26, these MRO
qualification requirements would be consistent with those of other
Federal agencies.
Proposed Sec. 26.183(b) [Relationships] would establish
requirements related to the relationships that would be permitted or
prohibited between the MRO, the licensee or other entity, and HHS-
certified laboratories. The first sentence of the proposed paragraph
would retain the portion of the first sentence of current Section
2.9(b) in Appendix A to Part 26 that permits the MRO to be an employee
of a licensee or other entity, or a contractor. The remaining sentences
of the proposed paragraph would be added to prohibit the MRO from being
an employee or agent of, or have any financial interest in, a
laboratory or a contracted operator of a licensee testing facility for
whom the MRO reviews drug testing results for the licensee or other
entity. The proposed prohibition would be added based upon the
experiences of other Federal agencies and would be consistent with the
related provision in the HHS Guidelines.
Proposed Sec. 26.183(c) [Responsibilities] would reorganize and
update the requirements in current Sec. 26.3 [Definitions] as well as
Sections 1.2, 2.4(j), 2.7(d), and 2.9(a) and (b) in Appendix A to Part
26 as they relate to the responsibilities of the MRO in Part 26
programs. The proposed rule would reorganize the current provisions and
combine them in one paragraph. In addition, the terminology used in the
proposed paragraph would be revised to be consistent with that used
throughout the proposed rule (e.g., ``non-negative''). The proposed
changes would meet Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule.
Proposed Sec. 26.183(c) would retain the requirement in current
Section 2.9(a) in Appendix A to Part 26 for the MRO to review positive
confirmatory drug test results and add a requirement for the MRO to
review non-negative results from validity testing, consistent with the
addition of requirements to conduct validity testing throughout the
proposed rule, as discussed with respect to proposed Sec.
26.31(d)(3)(i). The proposed
[[Page 50567]]
paragraph would also require the MRO to (1) identify evidence of
subversion of the testing process; (2) identify issues or problems
associated with the collection and testing of specimens; and (3) work
with FFD program management to assure the overall effectiveness of the
FFD program. The proposed rule would add these responsibilities to
clarify that the MRO carries programmatic responsibilities within a
licensee's or other entity's FFD program, in addition to responsibility
for reviewing drug and specimen validity test results. These proposed
additional responsibilities would strengthen the effectiveness of FFD
programs by ensuring that the MRO's expertise is brought to bear in the
management of FFD programs. The proposed paragraph would also increase
the consistency of the MROs' responsibilities under Part 26 with the
responsibilities of MROs in the drug and alcohol testing programs of
other Federal agencies. Therefore, the proposed changes would meet Goal
1 of this rulemaking, which is to update and enhance the consistency of
Part 26 with advances in other relevant Federal rules and guidelines,
and Goal 3, which is to improve the effectiveness and efficiency of FFD
programs.
Proposed Sec. 26.183(c)(1) would retain and update the
requirements contained in the current definitions of the term,
``Medical Review Officer,'' in Sec. 26.3 and Sections 1.2 and 2.9(b)
in Appendix A to Part 26. The proposed rule would continue to require
the MRO to examine alternate medical explanations for any non-negative
test result, which would include non-negative results of confirmatory
validity testing as well as positive confirmatory drug test results.
The proposed paragraph would also retain the current requirement for
the MRO to interview the donor and review the donor's medical history
and any other relevant biomedical factors as well as all medical
records that the donor may make available to the MRO. In addition to
the responsible use of legally prescribed medication, the proposed rule
would require the MRO to consider a documented condition or disease
state and the demonstrated physiology of the donor in determining
whether a non-negative test result is an FFD policy violation. The
proposed rule would require the MRO to consider the latter factors
because they may cause some non-negative validity test results. The
proposed changes would be necessary for consistency with the addition
of requirements to conduct validity testing throughout the proposed
rule, as discussed with respect to proposed Sec. 26.31(d)(3)(i), as
well as to increase the consistency of Part 26 with advances in other
relevant Federal rules and guidelines, which is Goal 1 of this
rulemaking.
Proposed Sec. 26.183(c)(2) would retain the meaning of the last
sentence of current Section 2.9(b) in Appendix A to Part 26 with minor
editorial revisions for consistency with the terminology used
throughout the proposed rule. For example, the proposed rule would
replace the term,'' split samples,'' in the current sentence with the
term, ``split specimens.'' The proposed changes would be made for
increased clarity in the language of the rule.
Proposed Sec. 26.183(d) [MRO staff] would be added to establish
requirements related to individuals who provide routine administrative
support functions to MROs, whether the individuals are employees of the
licensee or other entity, employees of the MRO, or employees of an
organization with whom the licensee or other entity contracts for MRO
services. The proposed rule would add requirements related to MRO staff
because these individuals (1) have access to drug test results that are
forwarded to an MRO from the HHS-certified laboratory; (2) perform some
administrative functions for MROs that permit them to view donors'
private medical information; and (3) often have contact with donors.
The NRC is not aware of any instances in which individuals who serve as
MRO staff have compromised the confidentiality of donors' test results,
medical information, or otherwise acted improperly in Part 26 programs.
However, the proposed rule would adopt requirements related to the MRO
staff function from the regulations of other Federal agencies who
similarly permit MRO staff to provide administrative support to MROs to
ensure that donors' medical information is handled with the highest
concern for individual privacy. The proposed requirement would also
ensure that information related to non-negative test results is not
released to licensee or other entity management personnel until the MRO
has determined that a donor has violated the FFD policy. These proposed
changes would meet Goal 1 of this rulemaking, which is to update and
enhance the consistency of Part 26 with advances in other relevant
Federal rules and guidelines, and Goal 7, which is to protect the
privacy and due process rights of individuals who are subject to Part
26.
Proposed Sec. 26.183(d)(1) [Direction of MRO staff activities]
would be added to require an MRO to be directly responsible for the
administrative, technical, and professional activities of individuals
who perform MRO staff duties. The NRC does not intend, through use of
this language, to mandate that MROs must share the same physical space
with all their staff members at all times. Direction of staff
activities need not occur face-to-face on an all-day, every-day basis.
Direction may also take place through using a variety of electronic
communications. However, the proposed rule would require that the MRO's
direction of staff must be meaningful. Meaningful direction would
involve (1) personal oversight of staff members' work; (2) personal
involvement in their performance evaluation, hiring, and firing; (3)
line authority over the staff for decisions, direction and control; and
(4) regular contact and oversight concerning drug testing program
matters. The proposed rule would also require that the MRO's direction
and control of the staff members cannot be superseded by or delegated
to anyone else with respect to the review of negative tests and other
functions that staff members perform for the MRO. In addition, the
proposed rule would require that MROs must personally review a
confirmed positive drug test result that is received from the HHS-
certified laboratory, as well an adulterated or substituted result,
consistent with the addition of requirements to conduct validity
testing throughout the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.183(d)(1)(i) would require that MRO staff duties
must be independent from any other activity or interest of the licensee
or other entity. The proposed rule would add this requirement because,
by contrast to other Federal agencies' regulations, Part 26 permits
employees of licensees and other entities to perform MRO staff
activities for MROs who work off site and are not physically present to
supervise the staff. These circumstances may provide greater
opportunities for inadvertent compromise of the independence of the MRO
function than situations in which the MRO and his or her staff are
physically co-located, such as the inadvertent release of non-negative
test results before the MRO has reviewed the results with the donor.
Therefore, the NRC believes that the proposed requirement is necessary
to protect the integrity of the MRO function and donors' privacy.
Proposed Sec. 26.183(d)(ii) would be added to further specify the
MRO's responsibilities for directing MRO staff. These responsibilities
would include, but would not be limited to, ensuring that the
procedures that must be
[[Page 50568]]
followed by MRO staff meet the regulations of this part and HHS' and
professional standards of practice, and that personal information about
the donor is maintained confidential with the highest regard for
individual privacy. The proposed requirements would meet Goal 7 of this
rulemaking, which is to protect the privacy and due process rights of
individuals who are subject to Part 26.
Proposed Sec. 26.183(d)(1)(iii) would also be added to prohibit
the MRO from delegating his or her responsibilities for directing MRO
staff activities to any individual or entity, other than another MRO.
Although the NRC is unaware of any instances in which the MRO function
has been compromised by MRO staff in Part 26 programs, the experience
of other Federal agencies has indicated that clear limits on who may
direct MRO staff activities are advisable to maintain the independence
and integrity of the MRO function. Therefore, proposed Sec.
26.183(d)(1)(iii) would establish these clear limits.
Proposed Sec. 26.183(d)(2) [MRO staff responsibilities] would be
added to specify the job duties that MRO staff may and may not perform.
The proposed provisions would also be based on the experience of other
Federal agencies, which has indicated that clear limits on MRO staff
job duties are necessary to protect donor confidentiality and the
integrity of the MRO process. Proposed Sec. 26.183(d)(2)(i) would
permit MRO staff to receive from the HHS-certified laboratory, review,
and report negative test results to the licensee's or other entity's
designated reviewing official, under the MRO's direction. Proposed
Sec. 26.183(c)(2)(ii) would permit MRO staff to review the custody-
and-control forms for specimens that the laboratory reports as non-
negative and correct errors, but would require the MRO to review and
approve the corrections. Proposed Sec. 26.183(d)(2)(iii) would
prohibit staff from conducting interviews with donors to discuss non-
negative test results and requesting or reviewing medical information
from donors related to any non-negative test results. Proposed Sec.
26.183(c)(2)(iv) would prohibit MRO staff from reporting or discussing
non-negative test results received from the HHS-certified laboratory
with any individuals other than the MRO and other MRO staff. The
proposed provisions would be necessary to protect donor confidentiality
and the integrity of the MRO review process while permitting licensees
and other entities to realize the cost efficiencies associated with the
MRO delegating some tasks to staff.
Section 26.185 Determining a Fitness-for-Duty Policy Violation
Proposed Sec. 26.185 [Determining a fitness-for-duty policy
violation] would amend requirements related to the MRO's determination
that a non-negative test result constitutes an FFD policy violation, as
follows:
Proposed Sec. 26.185(a) [MRO review required] would amend portions
of current Section 2.9(a) in Appendix A to Part 26, which establishes
requirements for the MRO's review of test results from the HHS-
certified laboratory. The term, ``non-negative test result,'' would be
used in the proposed paragraph to indicate that the MRO's review would
encompass validity test results, as well as drug test results,
consistent with the addition of validity testing requirements in the
proposed rule. The proposed paragraph would also expand the MRO's
responsibilities to include assisting the licensee or other entity in
determining whether a donor has attempted to subvert the testing
process. These responsibilities may include, but would not be limited
to, reviewing non-negative validity test results and authorizing the
testing at an HHS-certified laboratory of any suspicious substance
discovered in a donor's pockets that could be used to adulterate or
substitute a urine specimen. The proposed change would be consistent
with the NRC's increased concern with potential subversion of the
testing process, as discussed with respect to proposed Sec.
26.31(d)(3)(i). The proposed rule would also delete the current
reference to ``nuclear power plant worker'' and replace it with
``individual,'' because persons other than nuclear power plant workers
would be subject to the proposed requirement. In addition, the proposed
rule would eliminate the current requirement for the MRO to review
blood test results from the HHS-certified laboratory because the
proposed rule would no longer permit donors to request testing of a
blood specimen for alcohol, as discussed with respect to proposed Sec.
26.83(a). However, the proposed paragraph would retain the current
requirement that the MRO must complete the review of any non-negative
test results before transmitting results to a licensee's or other
entity's designated representative.
Proposed Sec. 26.185(b) [Reporting of initial test results
prohibited] would retain the intent of the requirement in the last
sentence of current Section 2.9(a) in Appendix A to Part 26.
Specifically, the proposed rule would continue to prohibit the MRO from
communicating to licensees and other entities any non-negative initial
test results reported by the HHS-certified laboratory before
confirmatory testing has been completed and the MRO has conducted his
or her review. However, the proposed rule would extend this prohibition
to MRO staff, consistent with the addition of requirements related to
MRO staff in proposed Sec. 26.183(d), as discussed with respect to
that paragraph.
Proposed Sec. 26.185(c) [Discussion with the donor] would amend
current Section 2.9(c) in Appendix A to Part 26. The proposed rule
would continue to require the MRO to discuss a positive confirmatory
drug test result with the donor before determining that the FFD policy
had been violated. The proposed rule would add a requirement for the
MRO to discuss non-negative confirmatory validity test results with the
donor as part of the review process, consistent with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i). The
proposed rule would add a reference to ``other occurrence'' to address
circumstances in which the donor may have engaged in a subversion
attempt that would be detected through other means, including, but not
limited to, the specimen collection process in proposed Subpart E
[Collecting Specimens for Testing]. The proposed rule would eliminate
the current requirement for the MRO to contact the EAP. Under the
proposed rule, referral to the EAP would be at the licensee's or other
entity's discretion, as documented in FFD procedures. The current
requirement would be eliminated because most licensees terminate the
employment of individuals who have a confirmed non-negative drug test
result, and it would be inappropriate to require licensees and other
entities to provide EAP services to persons they will no longer employ.
If a licensee or other entity plans to consider granting authorization
to the individual after his or her authorization has been terminated
unfavorably for the FFD policy violation, the proposed rule would
require the licensee or other entity to meet the applicable
requirements of proposed Sec. 26.69 [Authorization with potentially
disqualifying fitness-for-duty information]. The changes in the
proposed paragraph would be made for consistency with other proposed
changes to the regulation.
Proposed Sec. 26.185(d) [Donor unavailability] would be added to
clarify the circumstances in which the MRO may confirm a non-negative
test
[[Page 50569]]
result or other occurrence as an FFD policy violation without having
first discussed the test result or occurrence with the donor. These
circumstances would include (1) the donor expressly declining the
opportunity to discuss the possible FFD policy violation with the MRO
in proposed Sec. 26.185(d)(1); (2) the donor failing to contact the
MRO within one business day after being contacted by the licensee or
other entity or an MRO staff member in proposed Sec. 26.185(d)(2); and
(3) the MRO being unable to contact the donor after making a reasonable
effort to do so in proposed Sec. 26.185(d)(2). The proposed paragraphs
would provide more detailed guidance than the first sentence of current
Section 2.9(c) in Appendix A to Part 26, in response to the many
questions that have arisen regarding implementation of the requirement
for MROs to discuss test results with the donor. The proposed revisions
would also respond to stakeholders requests during the public meetings
discussed in Section V. In questions to the NRC staff and during the
public meetings, licensees have pointed out that the current rule makes
no provision for these circumstances, which do occasionally arise.
Therefore, the proposed paragraphs would address these circumstances.
For the same reasons, proposed Sec. 26.185(e) [Additional
opportunity for discussion] would specify procedures for addressing a
circumstance in which the donor was unable to contact the MRO to
discuss a non-negative test result or other occurrence. The proposed
paragraph would permit the donor to present information to the MRO
documenting the circumstances that unavoidably prevented the donor from
being contacted by or from contacting the MRO, and would permit the MRO
to reopen the procedure for determining whether the donor had violated
the FFD policy. The proposed paragraph would also permit the MRO to
modify the initial determination based on the information that the
donor provides.
The requirements in proposed Sec. 26.185(d) and (e) would
incorporate the related requirements in 49 CFR Part 40, ``Procedures
for Department of Transportation Workplace Drug and Alcohol Testing
Programs'' (65 FR 41944; August 9, 2001). Therefore, in addition to
responding to implementation questions from licensees and stakeholder
requests, the proposed provisions would meet Goal 1 of this rulemaking,
which is to update and enhance the consistency of Part 26 with advances
in other relevant Federal rules and guidelines.
Proposed Sec. 26.185(f)-(i) would be added to establish
requirements for the MRO's review of validity test results. These
proposed paragraphs would be added for consistency with the addition of
requirements to conduct validity testing throughout the proposed rule,
as discussed with respect to proposed Sec. 26.31(d)(3)(i).
Proposed Sec. 26.185(f) [Review of invalid specimens] would
clarify the MRO's responsibilities in the event that the HHS-certified
laboratory reports that a specimen is invalid. The proposed paragraph
would be consistent with related provisions in the HHS Guidelines, and
would be necessary because MRO actions in response to an invalid
specimen are not specified in the current rule. Proposed Sec.
26.185(f) would provide the MRO with several alternative courses of
action if a specimen is declared to be invalid by the laboratory, as
follows:
Proposed Sec. 26.185(f)(1) would require the MRO to consult with
the HHS-certified laboratory to determine whether additional testing by
another HHS-certified laboratory may be useful for completing testing
of the specimen. Another laboratory may use different testing methods
that could provide more definitive test results regarding the invalid
specimen, such as the ability to identify a new adulterant or obtain
valid drug test results despite the presence of an interfering
substance in the specimen. If the MRO and laboratory agree that
additional testing would be useful, the MRO would direct the laboratory
to forward an aliquot of the specimen to a second HHS-certified
laboratory for further testing.
Proposed Sec. 26.185(f)(2) would require the MRO to contact the
donor to determine whether there is an acceptable medical explanation
for the invalid result, if the MRO and HHS-certified laboratory agree
that testing at a second laboratory would not be useful. If the MRO
determines that there is an acceptable medical explanation for the
invalid result, the MRO would report to the licensee or other entity
that no FFD policy violation had occurred, but that a negative test
result had not been obtained. Because the specimen did not yield
negative test results, the licensee or other entity could not use the
invalid test result in the decision to grant or deny authorization.
However, the proposed paragraph would also require the MRO to assess
whether the medical condition would similarly affect a second specimen
collection. If the MRO determines that the medical condition is
temporary and would not affect a second specimen, he or she would
direct the licensee or other entity to collect another specimen from
the donor and the licensee or other entity would then rely upon the
results of the second test to make an authorization decision. The
proposed rule would not require the second specimen to be collected
under direct observation in this situation, because there would be no
reason to believe that the individual may have attempted to subvert the
testing process. If the MRO determines that the medical condition would
likely affect the validity of further urine specimens, the proposed
paragraph would permit the MRO to authorize an alternative method for
drug testing. At this time, the NRC declines to specify the alternative
methods that the MRO may authorize, which may include, but would not be
limited to, testing of alternate specimens, such as hair, oral fluids,
or sweat. The NRC would leave the selection of an alternative method to
the professional judgement of the MRO. The proposed rule also would
prohibit licensees and other entities from taking management actions or
imposing sanctions on the basis of an invalid test result from a
medical condition, because no FFD violation would have occurred.
Proposed Sec. 26.185(f)(3) would require the MRO to direct the
licensee or other entity to collect another specimen under direct
observation, if testing by another laboratory would not be useful in
obtaining a valid result and the donor did not provide an acceptable
medical explanation for the invalid specimen. The invasion of privacy
associated with a directly observed collection would be warranted in
this situation because the invalid specimen may be the result of a
subversion attempt. The proposed rule would require the licensee or
other entity to rely upon the test results from the directly observed
collection in authorization decision-making because the result from the
invalid specimen would be neither negative or non-negative, and so
could not meet the requirements for granting authorization to an
individual in proposed Subpart C [Granting and Maintaining
Authorization] or serve as the basis for imposing the sanctions
specified in proposed Subpart D [Management Actions and Sanctions].
Proposed Sec. 26.185(g) [Review of dilute specimens] would be
added to establish requirements for the MRO's review of positive
confirmatory drug test results from dilute specimens. The proposed
paragraph would be added because reviewing test results from a dilute
specimen is complex and MRO actions in response to a dilute specimen
are not addressed in the current rule.
Proposed Sec. 26.185(g)(1) would require the MRO to confirm a
drug-positive FFD
[[Page 50570]]
violation for a dilute specimen in which drugs or drug metabolites are
detected, if the MRO determines that there is no legitimate medical
explanation for the presence of the drugs or metabolites in the
specimen. There are many legitimate reasons for submitting a dilute
specimen, which is the basis for omitting the submission of a dilute
specimen as one type of subversion attempt for which a permanent denial
of authorization would be required in proposed Sec. 26.75(b). Although
neither the submission of a dilute specimen nor the presence of drugs
or drug metabolites in a dilute specimen establishes that the donor has
attempted to subvert the testing process without additional evidence of
subversion, the presence of drugs or metabolites in a dilute specimen
without a legitimate medical explanation is a sufficient basis for the
MRO to confirm that the donor has violated the FFD policy.
Proposed Sec. 26.185(g)(2) would permit the MRO to require the
HHS-certified laboratory to test a dilute specimen for drugs and drug
metabolites at the LOD of the confirmatory assay used, if the MRO has
reason to believe that the donor may have attempted to subvert the
testing process. The proposed rule would authorize the MRO to request
testing at the LOD for any drugs or drug metabolites for which testing
would be permitted in this part. The MRO would be permitted to request
testing at the LOD in these circumstances because the immunoassay tests
used for initial drug testing may not be sufficiently sensitive to
detect very low concentrations of drugs or metabolites in a dilute
specimen. However, confirmatory testing at the LOD may detect very low
concentrations of drugs or metabolites in a dilute specimen and,
therefore, would ensure that an attempt to hide drug abuse through
specimen dilution is unsuccessful.
Proposed Sec. 26.185(g)(2)(i)-(g)(2)(iii) would define the
circumstances that constitute a reason to believe that a donor may have
attempted to subvert the testing process and provide a sufficient basis
for the MRO to require the additional testing permitted in proposed
Sec. 26.185(g)(2). These circumstances would be the same as those
specified in proposed Sec. 26.115(a)(1)-(a)(3), as discussed with
respect to those provisions.
Proposed Sec. 26.185(g)(3) would clarify that the MRO may also
require the additional testing of a dilute specimen that would be
permitted in proposed Sec. 26.185(g)(2), if the specimen was collected
under direct observation, or if such testing is required by the SAE as
a result of a determination of fitness conducted under proposed Sec.
26.69 [Authorization with potentially disqualifying fitness-for-duty
information]. The proposed paragraph would add these permissions for
consistency with the related provisions in the proposed rule.
Proposed Sec. 26.185(g)(4) would require the MRO to determine
whether there is clinical evidence of the illegal use of opiates, if
opiates other than 6-AM at any concentration are detected in a dilute
specimen, before the MRO verifies that the donor has violated the FFD
policy. The proposed rule would not require an evaluation for clinical
evidence of illegal use of opiates for 6-AM, because it's presence in a
specimen is proof of heroin use. However, the proposed paragraph would
not establish cutoff levels below and above which an evaluation for
clinical evidence of illegal opiate use is not required (in contrast to
those contained in proposed paragraph (j) of this section), because the
concentration of opiates in a dilute specimen would not bear any known
relationship to the concentration of opiates in vivo (i.e., in the
donor's body). For similar reasons, the proposed rule would also
require an evaluation for clinical evidence of abuse before the MRO
determines that the donor has violated the FFD policy when drugs or
drug metabolites are detected in a dilute specimen, indicating that the
donor has used prescription or over-the-counter medications.
Proposed Sec. 26.185(h) [Review of substituted specimens] would be
added to establish requirements for the MRO review of substituted test
results. The proposed provisions would be added because MRO actions in
determining an FFD policy violation for a substituted specimen are not
addressed in the current rule. The proposed provisions would be
consistent with the related provisions in the HHS Guidelines.
Proposed Sec. 26.185(h)(1) would require the MRO to contact the
donor to determine whether there is a legitimate medical reason for the
substituted result. The proposed paragraph would require the MRO to
give the donor the opportunity to provide legitimate medical evidence,
within 5 business days of being contacted by the MRO, that the
individual's normal physiology produced the substituted result and
would establish requirements for the medical evidence that would be
necessary. The proposed rule would also provide examples of donor
claims that the MRO may not consider to be legitimate medical
explanations, including, but not limited to, race, gender, body weight,
and dietary factors.
Proposed Sec. 26.185(h)(2) would direct the MRO to report to the
licensee or other entity that the specimen was substituted, if the MRO
determines that there is no acceptable medical explanation for the
substituted test result.
Proposed Sec. 26.185(h)(3) would direct the MRO to report to the
licensee or other entity that no FFD policy violation has occurred, if
the MRO determines that the donor has provided an acceptable medical
explanation for the substituted test result.
Proposed Sec. 26.185(i) [Review of adulterated specimens] would
establish requirements for the MRO's review of adulterated test
results. The proposed provisions would be added because MRO actions in
determining an FFD policy violation for an adulterated specimen are not
addressed in the current rule. Proposed Sec. 26.185(i)(1) would
require the MRO to contact the donor and offer him or her the
opportunity to provide an acceptable medical explanation for the
adulterated result. The proposed rule would also specify the procedures
that the donor must follow in providing the medical explanation. If the
donor does not provide an acceptable medical explanation for the
adulterated result, proposed Sec. 26.185(i)(2) would require the MRO
to report to the licensee or other entity that the specimen is
adulterated. If the donor provides an acceptable medical explanation,
proposed Sec. 26.185(j)(3) would require the MRO to report that no FFD
policy violation had occurred. These proposed requirements would be
consistent with the related provisions in the HHS Guidelines.
Proposed Sec. 26.185(j) [Review for opiates, prescription and
over-the-counter medications] would amend current Section 2.9(d) in
Appendix A to Part 26 to address circumstances that have arisen since
Part 26 was first published and about which licensees have sought
guidance from the NRC. The proposed paragraph would amend the current
requirements in Section 2.9(d) in Appendix A to Part 26 and add others,
as follows:
Proposed Sec. 26.185(j)(1) would incorporate updated requirements
from the HHS Guidelines related to the MRO's review of a positive drug
test result for opiates. The proposed rule would revise, but retain the
meaning of the requirement for the MRO to determine that there is
clinical evidence of illegal use of opiates, which appears in current
Section 2.9(d) in Appendix A to Part 26. Because some licensees and
other entities rely on MROs who work off site and are not available to
conduct
[[Page 50571]]
the required assessment, the proposed rule would permit the MRO to
designate another licensed physician who has knowledge of the clinical
signs of drug abuse to conduct the evaluation. The proposed change
would continue to ensure that the clinical assessment is performed by a
qualified physician while reducing unnecessary burden by permitting FFD
programs to continue to rely on off-site MROs. Therefore, the proposed
change would meet Goal 5 of this rulemaking, which is to improve Part
26 by eliminating or modifying unnecessary requirements.
The proposed rule would make other changes to current Section
2.9(d) in Appendix A to Part 26. The proposed paragraph would eliminate
the examples of clinical signs of opiate abuse in current Section
2.9(d), because these signs are addressed as part of the training that
MROs would obtain in order to pass the comprehensive certification
examination required in proposed Sec. 26.183(a) [Qualifications]. The
proposed rule would retain the provision in current Section 2.9(d) that
permits the MRO to omit the evaluation for clinical evidence of abuse
if the laboratory identifies 6-AM in the specimen. However, the
proposed rule would add permission for the MRO to omit the evaluation
if the morphine or codeine concentration in the specimen is equal to or
greater than 15,000 ng/mL without a legitimate medical explanation for
the presence of opiates at or above this concentration. The proposed
change would be made because, in the experience of other Federal
programs, such concentrations without a legitimate medical explanation
can only indicate substance abuse. In addition, the proposed rule would
prohibit the MRO from considering consumption of food products as a
legitimate medical explanation for the specimen having morphine or
codeine concentrations at or above 15,000 ng/mL, given that food
consumption could not result in a concentration at this level.
Proposed Sec. 26.185(j)(2) would retain the last sentence of
current Section 2.9(d) in Appendix A to Part 26, which requires the MRO
to determine whether there is clinical evidence, in addition to the
positive drug test result, of abuse of these substances or their
derivatives.
Proposed Sec. 26.185(j)(3) would be added to provide greater
consistency in MRO determinations related to a donor's use of another
person's prescription medication. The NRC is aware that MROs in
different FFD programs have varied in the determination they make as to
whether the use of another person's prescription medication is an FFD
policy violation. The proposed paragraph would clarify the NRC's intent
with respect to these circumstances. In the proposed rule, if a donor
claims, and the MRO confirms, that a non-negative drug test result is
due to the unauthorized use of another person's prescription
medication, the proposed rule would require the MRO to evaluate or
ensure that the donor is evaluated for clinical evidence of abuse. If
no clinical evidence of abuse is identified, the MRO would report to
the licensee or other entity that a violation of the FFD policy
regarding misuse of a prescription medication had occurred. If clinical
evidence of abuse is identified, the MRO would confirm that the test
results are positive for the drug or metabolites detected.
Proposed Sec. 26.185(j)(4) would be added to assure greater
consistency in MRO determinations related to a donor's use of a
prescription or over-the-counter medication that the donor obtained
legally in a foreign country. Again, the NRC is aware that MROs in
different FFD programs have varied in the determination they make as to
whether the use of medications legally obtained in a foreign county is
an FFD policy violation. The proposed paragraph would clarify the NRC's
intent with respect to these circumstances. At the licensee's or other
entity's discretion and in accordance with the FFD policy and
procedures, the proposed rule would permit the MRO to confirm a test
result as negative if there is a legitimate medical use for the
medication that the donor obtained legally in a foreign country and the
donor has used it properly for its intended medical purpose. The
proposed rule would prohibit the MRO from confirming a test result as
negative if the drug used has no legitimate medical purpose, including,
but not limited to phencyclidine and heroin.
Proposed Sec. 26.185(j)(5) would be added to prohibit the MRO from
considering the consumption of food products, supplements, and other
preparations that are available over-the-counter as a legitimate
medical explanation for the specimen having drugs or drug metabolites
above the cutoff levels specified in proposed Sec. 26.163, including,
but not limited to hemp products and coca leaf tea. In so doing, the
proposed rule would provide guidance concerning a potential subversion
technique that has become an issue for several licensees (i.e., claims
of ingestion of hemp food products as the basis for a positive
marijuana test). Ingestion of food products containing hemp seeds or
extracts has produced marijuana positive test results, even though the
seller claimed that the seeds or extracts were sterilized to remove the
THC metabolite. The NRC endorses the Federal policy in this matter that
was published by the Department of Transportation, with the concurrence
of the Departments of Justice and Health and Human Services and the
Office of National Drug Control Policy. MROs must never accept an
assertion of consumption of a hemp food product as a basis for
confirming that a marijuana test is negative. Consuming a hemp food
product is not a legitimate medical explanation for a prohibited
substance or metabolite in an individual's specimen. When a specimen is
positive for THC, the only legitimate medical explanation for its
presence is a prescription for marinol. Under proposed Sec.
26.29(a)(6) and (a)(7), individuals who are subject to Part 26 would
receive training in order to be able to avoid ingesting substances that
could result in positive drug test results, such as over-the-counter
medications, food products, supplements, and other preparations.
Proposed Sec. 26.185(j)(6) would be added to prohibit the MRO from
accepting the use of any drugs that are listed in Schedule I of section
202 of the Controlled Substances Act [21 U.S.C. 812] as a legitimate
medical explanation for a positive confirmatory drug test result, even
if the drug may be legally prescribed and used under State law. Drugs
that are listed in Schedule I of section 202 of the Controlled
Substances Act have the following characteristics: (1) The drug or
other substance has a high potential for abuse; (2) the drug or other
substance has no currently accepted medical use in treatment in the
United States; and (3) there is a lack of accepted safety for use of
the drug or other substance under medical supervision. The proposed
prohibition would primarily be intended to address the medical use of
marijuana, which some States permit, as well as the use of certain
hallucinogenic drugs. Although some have argued that the use of such
drugs under State laws may not adversely reflect on an individual's
trustworthiness and reliability, the proposed requirement would be
necessary to ensure that individuals who are subject to this part can
be trusted and relied upon to comply with Part 26 requirements and are
not impaired from using these drugs when performing duties that require
them to be subject to this part.
Proposed Sec. 26.185(k) [Results consistent with legitimate drug
use] would amend current Section 2.9(f) in Appendix A to Part 26. The
current
[[Page 50572]]
paragraph instructs the MRO to report to the licensee that a drug test
result is negative if, after review, the MRO determines that there is a
legitimate medical explanation for the positive test result and that
use of the substance identified through testing in the manner and at
the dosage prescribed does not reflect a lack of reliability and is
unlikely to create on-the-job impairment. However, the current
provision does not provide instructions for MRO action in the case of
an individual whose drug use is legitimate but may cause impairment on
duty. Therefore, if the MRO determines that a risk exists, the proposed
rule would require that a determination of fitness must be performed.
Because the MRO determined that the drug test result was negative, the
licensee or other entity would not impose sanctions on the individual.
However, the results of the determination of fitness may indicate a
need to establish controls and conditions on the individual's
performance of certain job duties, in order to ensure that any
impairment from the drug use does not result in adverse impacts on
public health and safety or the common defense and security. The
proposed provision would meet Goal 3 of this rulemaking, which is to
improve the effectiveness of FFD programs, by providing greater
assurance that individuals who are subject to the rule are fit to
safely and competently perform their duties.
Proposed Sec. 26.185(l) [Retesting authorized] would amend current
Section 2.9(e) in Appendix A to Part 26, which permits the MRO to
authorize retesting of an aliquot of a specimen if there is any
question about the accuracy or validity of a drug test result. The
proposed rule would retain the provisions in current Section 2.9(e)
that permit a donor to request a retest of an aliquot of a single
specimen or a split specimen, if the FFD program follows split specimen
procedures. However, the proposed rule would update the current
requirement for consistency with the terminology used throughout the
proposed rule (e.g., ``Bottle B'' to refer to a split specimen), as
discussed with respect to proposed Sec. 26.5 [Definitions]. The
proposed rule would also add a requirement that the retesting must be
conducted at a second HHS-certified laboratory that did not conduct the
original tests. The proposed requirement that retesting must be
performed at a second HHS-certified laboratory would ensure the
independence of the second testing and provide additional protection of
donors' due process rights under the proposed rule. In addition, the
proposed requirement would increase the consistency of Part 26 with
related provisions in the HHS Guidelines. The proposed rule would also
require the donor to request the retest in writing, in order to ensure
donors' control over the specimen and rights to privacy, as discussed
with respect to Sec. 26.135(b).
Proposed paragraph Sec. 26.185(m) [Results scientifically
insufficient] would amend current Section 2.9(g) in Appendix A to Part
26, which permits the MRO to determine that a positive drug test result
is scientifically insufficient and declare it negative. The proposed
paragraph would change some of the terminology used in the current
paragraph (e.g., ``samples'' would be changed to ``specimens'') for
consistency with the terminology used throughout the proposed rule, as
discussed with respect to proposed Sec. 26.5 [Definitions]. The
proposed rule would also make other changes to this paragraph, as
follows:
The proposed paragraph would amend the first sentence of the
current requirement, which permits the MRO to report to the licensee or
other entity that a test result is negative if he or she determines
that it is scientifically insufficient for further action. The proposed
rule would instruct the MRO to report that the test result is ``not an
FFD policy violation'' in these circumstances, rather than a negative
test result. The proposed change would be made for consistency with
other changes in the proposed rule related to invalid test results, as
discussed with respect to proposed Sec. 26.185(f). That is, a test
result that the MRO determines to be scientifically insufficient for
further action (as well as an invalid test result) could not be a basis
for a licensee or other entity to grant or deny authorization or impose
sanctions because it would be neither a negative nor non-negative test
result. Therefore, the proposed change would meet Goal 6 of this
rulemaking, which is to improve clarity in the language of the rule.
The proposed rule would also add a statement to the current
paragraph to indicate that the MRO is neither expected nor required to
request retesting of the specimen unless, in the sole opinion of the
MRO, such retesting is warranted. The proposed rule would add this
statement because, in the experience of other Federal agencies, some
MROs have been pressured by the organization to whom they provide
services to request retesting of specimens that the MRO has confirmed
to be non-negative. Although the NRC is not aware of any such instances
in Part 26 programs, the proposed rule would clarify that the MRO,
alone, is authorized to request retesting to further protect the
independence of the MRO function.
In addition, the last sentence of current Section 2.9(g), which
contains records retention requirements, would be moved to Sec.
26.215(b)(11) of proposed Subpart J [Recordkeeping and Reporting
Requirements] and grouped with other records retention requirements in
the proposed rule for organizational clarity.
Proposed Sec. 26.185(n) [Evaluating results from a second
laboratory] would establish new requirements for the MRO's
determination of an FFD policy violation based on a retest of a single
specimen or a test of the specimen in Bottle B of a split specimen. The
proposed paragraph would specify that the test result(s) from the
second HHS-certified laboratory would supersede the confirmatory test
results provided by the HHS-certified laboratory that performed the
original testing of the specimen. The proposed rule would incorporate
these requirements from the HHS Guidelines because the current rule
does not address MRO actions in response to test results from a second
laboratory. Therefore, the proposed paragraph would be consistent with
the related provisions in the HHS Guidelines and would meet Goal 1 of
this rulemaking, which is to update and enhance the consistency of Part
26 with advances in other relevant Federal rules and guidelines.
Proposed Sec. 26.185(o) [Re-authorization after a first violation]
would be added to address the MRO's review of drug test results
following a first violation of the FFD policy based on a confirmed
positive drug test result. The current rule does not require the MRO to
evaluate whether drug test results in these instances indicate
subsequent drug use after a first confirmed positive drug test result,
and MROs from different FFD programs have implemented different
policies. Specifically, the proposed paragraph would require the MRO to
determine whether subsequent drug test results indicate further drug
use since the first positive drug test result was obtained. For
example, because marijuana metabolites are fat-soluble and may be
released slowly over an extended period of time, a second positive test
result for marijuana from a test that is performed within several weeks
after a first confirmed positive test result for marijuana may not, in
fact, indicate further marijuana use. Therefore, in this case, the
proposed provision would prohibit the MRO from determining that a
second FFD policy violation for
[[Page 50573]]
marijuana had occurred, if the quantitative results from confirmatory
testing of the second specimen are positive for marijuana metabolites,
but at a concentration that would be inconsistent with additional
marijuana use since the first non-negative test result was obtained. If
the MRO concludes that the concentration of marijuana metabolites
identified by confirmatory testing is inconsistent with further
marijuana use since the first positive test result, the MRO would
declare the test result as negative, even if the quantitative test
result exceeds the 15 ng/mL confirmatory cutoff level specified in this
part or a licensee's or other entity's more stringent cutoff level. The
proposed provision would prevent individuals from being subject to a 5-
year denial of authorization for a second confirmed positive drug test
result under proposed Sec. 26.57(e), when the donor has not engaged in
further drug use, consistent with Goal 7 of this rulemaking, which is
to protect the privacy and due process rights of individuals who are
subject to Part 26.
Proposed Sec. 26.185(p) [Time to complete MRO review] would amend
current Sec. 26.24(e), which requires the MRO to complete his or her
review of test results and notify management of the results of his or
her review within 10 days after an initial presumptive positive
screening test result. The proposed rule would replace the current
phrase, ``initial presumptive positive screening test result,'' with
the phrase, ``initial non-negative test result,'' for consistency with
the terminology used throughout the proposed rule, as discussed with
respect to proposed Sec. 26.5 [Definitions]. The proposed paragraph
would also require the MRO to report his or her determination that a
non-negative test result is an FFD policy violation in writing to the
licensee or other entity and in a manner that ensures the
confidentiality of the information. The proposed changes would be made
for consistency with the related provisions in the HHS Guidelines.
Section 26.187 Substance Abuse Expert
A new Sec. 26.187 [Substance abuse expert] would be added to
establish minimum requirements for a new position within FFD programs,
the ``substance abuse expert'' (SAE), for the reasons discussed in
Section IV. C.
Proposed Sec. 26.187(a) [Implementation] would be added to require
SAEs to meet the requirements of this proposed section within 2 years
of the date on which the final rule is published in the Federal
Register. The 2-year period would be proposed in order to ensure that
professionals who may currently be performing determinations of
fitness, but who do not meet these proposed requirements, have the time
necessary to obtain the required credentials, knowledge, and
qualification training.
Proposed Sec. 26.187(b) [Credentials] would be added to establish
the credentials required for an individual to serve as an SAE under
this part. The proposed rule would require that the SAE must possess
the extensive education, training, and supervised clinical experience
that are prerequisites for obtaining the professional credentials
listed in proposed Sec. 26.187(b)(1)-(b)(5). However, proposed Sec.
26.187(c)-(e) would require an SAE to possess additional knowledge and
experience directly related to substance abuse disorders and the
requirements of this part.
Proposed Sec. 26.187(c) [Basic knowledge] and (d) [Qualification
training] would be added to establish the specific areas of expertise
and training that would be required for an individual to serve as an
SAE under this part. The proposed knowledge and training requirements
in these two paragraphs would be necessary to ensure that SAEs possess
the knowledge and clinical experience required to perform the SAE
function effectively in a Part 26 program.
Proposed Sec. 26.187(c) would require SAEs to possess the
following types of knowledge: (1) Knowledge of and clinical experience
in the diagnosis and treatment of alcohol and controlled-substance
abuse disorders, in proposed Sec. 26.187(c)(1); (2) knowledge of the
SAE function as it relates to individuals who perform the job duties
that require an individual to be subject to this part, in proposed
Sec. 26.187(c)(2); and (3) knowledge of this part and any changes to
its requirements, in proposed Sec. 26.187(c)(3).
Proposed Sec. 26.187(d) would establish the topical areas in which
an SAE must be trained. The proposed qualification training
requirements would include training in the following areas: (1) The
background, rationale, and scope of this part, in proposed Sec.
26.187(d)(1); (2) key drug and alcohol testing requirements of this
part, in proposed Sec. 26.187(d)(2) and (d)(3), respectively; (3) SAE
qualifications and prohibitions, in proposed Sec. 26.187(d)(4); (4)
the role of the SAE in making determinations of fitness, and developing
treatment recommendations and followup testing plans, in proposed Sec.
26.187(d)(5); (5) procedures for consulting and communicating with
licensee or other entity officials and the MRO, in proposed Sec.
26.187(d)(6); (6) reporting and recordkeeping requirements of this part
as they related to the SAE function, in proposed Sec. 26.187(d)(7);
and (7) appropriate methods for addressing issues that SAEs confront in
carrying out their duties under this part, in proposed Sec.
26.187(d)(8).
Proposed Sec. 26.187(e) [Continuing education] would be added to
ensure that SAEs maintain the knowledge and skills required to perform
the SAE function under this part. The proposed paragraph would require
SAEs to complete at least 12 continuing professional education hours
relevant to performing the SAE function during each 3-year period
following completion of initial qualification training. Proposed Sec.
26.187(e)(1) would describe the topics that must be covered in the
continuing education training, to include, but not limited to, new drug
and alcohol testing technologies, and any rule interpretations or new
guidance, rule changes, or other developments in SAE practice under
this part, since the SAE completed the qualification training
requirements in proposed Sec. 26.187(d). Proposed Sec. 26.187(e)(2)
would require documented assessment of the SAE's understanding of the
material presented in the continuing education activities in order to
ensure that the SAE learned the material. These proposed continuing
educations requirements would necessary to ensure that SAEs maintain
updated knowledge and skills to continue performing the SAE function
effectively under this part.
Proposed Sec. 26.187(f) [Documentation] would be added to specify
the records that the SAE must maintain in order to demonstrate that he
or she meets the proposed requirements of this section. The SAE would
be required to provide the documentation, as requested, to NRC
representatives, and to licensees or other entities who would rely on
the SAE's services. Licensees and other entities who intend to rely
upon a determination of fitness that is made by an SAE under another
FFD program would also be required to have access to this
documentation. These proposed requirements would be necessary to ensure
that licensees and other entities, and the NRC, have access to the
documentation required to verify that the SAE's knowledge, training,
and practice meet the requirements of this part.
Proposed Sec. 26.187(g) [Responsibilities and prohibitions] would
be added to specify the responsibilities of SAEs within a licensee's or
other entity's FFD program and their limitations.
[[Page 50574]]
Proposed Sec. 26.187(g)(1) would specify at least three
circumstances in which the SAE would be responsible for making a
determination of fitness under the proposed rule. In proposed Sec.
26.187(g)(1)(i), an SAE may be called upon to make a determination of
fitness regarding an applicant for authorization when the self-
disclosure, the suitable inquiry, or other sources of information
identify potentially disqualifying FFD information about the applicant.
In proposed Sec. 26.187(g)(1)(ii), an SAE may be called upon to make a
determination of fitness when an individual has violated the substance
abuse provisions of a licensee's or other entity's FFD policy,
including, but not limited to a first confirmed positive drug test
result. Related provisions in proposed Sec. 26.69 [Authorization with
potentially disqualifying FFD information] would require the licensee
or other entity to rely upon the results of the SAE's determination of
fitness when making a decision to grant or maintain an individual's
authorization and implement any recommendations from the SAE for
treatment and followup testing. In proposed Sec. 26.187(g)(1)(iii), an
SAE may be called upon to make a determination of fitness when there is
a concern that an individual may be impaired as a result of the use of
prescription or over-the-counter medications, or alcohol. Related
provisions in proposed Sec. 26.77 [Management actions regarding
possible impairment] would require the licensee or other entity to rely
upon the results of the SAE's determination of fitness when determining
whether an individual may perform job duties that require the
individual to be subject to this part. Therefore, the proposed
paragraph would be added for consistency with other, related provisions
in the proposed rule.
Proposed Sec. 26.187(g)(2) would be added to require the SAE to
act as a referral source to assist an individual's entry into an
appropriate treatment or education program and prohibit the SAE from
engaging in any activities that could create the appearance of a
conflict of interest. Proposed Sec. 26.187(g)(2)(i) would prohibit the
SAE from referring an individual to any organization with whom the SAE
has a financial relationship, including the SAE's private practice, to
avoid creating the appearance of a conflict of interest. However,
proposed Sec. 26.187(g)(2)(ii)(A)-(g)(2)(ii)(D) would specify
circumstances in which the prohibition in proposed Sec.
26.187(g)(2)(i) would not apply. In general, the proposed rule would
permit the SAE to refer an individual to an entity with whom the SAE
has a financial relationship in situations where treatment and
educational resources may be limited by cost considerations or
geographical availability. These proposed provisions would be necessary
to ensure that the SAE's determinations are not influenced by financial
gain and that individuals who are subject to the rule and the public
can have confidence in the integrity and independence of the SAE
function in Part 26 programs.
Section 26.189 Determination of Fitness
Proposed Sec. 26.189 [Determination of fitness] would be added to
present together in one section and amend current requirements related
to the determination that an individual is fit to safely and
competently perform the job duties that require individuals to be
subject to this part. The terms, ``medical assurance'' and ``medical
determination of fitness,'' used in various sections of the current
rule [e.g., Sec. 26.27(a)(3), (b)(2) and (b)(4)] would be replaced
with the term, ``determination of fitness,'' as defined in this
proposed section. This proposed change in terminology would be made
because the rule would permit healthcare professionals other than
licensed physicians to conduct determinations of fitness, as discussed
with respect to proposed Sec. 26.187 [Substance abuse expert].
Therefore, the proposed change would meet Goal 6 of this rulemaking,
which is to improve clarity in the organization and language of the
rule.
Proposed Sec. 26.189(a) would be added. The first sentence of the
proposed paragraph would define the term, ``determination of fitness.''
This term would refer to the process followed to determine whether
there are indications that an individual may be in violation of the
licensee's or other entity's FFD policy or is otherwise unable to
safely and competently perform his or her duties.
In general, the proposed rule would require that professionals who
perform determinations of fitness must be qualified and possess the
requisite clinical experience, as verified by the licensee or other
entity, to assess the specific fitness issues presented by an
individual whose fitness may be questionable. The proposed approach to
designating the healthcare professionals who may conduct a
determination of fitness focuses on the appropriateness of the
professional's expertise for addressing the subject individual's
fitness issue, rather than on the professional's organizational
affiliation [see the discussion of proposed Sec. 26.69(b)(4)] or
whether the individual is a licensed physician. Therefore, proposed
Sec. 26.189(a)(1)-(a)(5) would provide examples of the healthcare
professionals who would be qualified to address various fitness issues
that may arise in a FFD program. When a decision must be made to
determine whether an individual may be granted or maintain
authorization and a substance abuse disorder is involved, only
professionals who meet the requirements to serve as an SAE would be
permitted to make determinations of fitness under proposed Sec.
26.189(a)(1). The proposed rule would permit other healthcare
professionals to perform determinations of fitness that involve
assessing and diagnosing impairment from causes other than substance
abuse, such as clinical psychologists in proposed Sec. 26.189(a)(2),
psychiatrists in proposed Sec. 26.189(a)(3), physicians in proposed
Sec. 26.189(a)(4), or an MRO in proposed Sec. 26.189(a)(5),
consistent with their professional qualifications. The proposed rule
would also permit other licensed and certified professionals who are
not listed in the proposed paragraph, such as registered nurses or
physicians' assistants who have the appropriate training and
qualifications, to perform a determination of fitness regarding
specific fitness issues that are within their areas of expertise.
However, the critical tasks of assessing the presence of a substance
abuse disorder, providing input to authorization decisions, and
developing treatment plans would be reserved for healthcare
professionals who have met the specific training, clinical experience,
and knowledge requirements for an SAE under proposed Sec. 26.187
[Substance abuse expert] for the reasons discussed with respect to that
proposed section.
The proposed rule would also prohibit healthcare professionals who
may conduct a determination of fitness for a Part 26 program from
addressing fitness issues that are outside of their specific areas of
expertise, consistent with the ethical standards of healthcare
professionals' disciplines as well as State laws. The proposed rule
would add this prohibition to clarify that the ethical standards and
State laws also apply to making determinations of fitness under Part 26
because a determination of fitness conducted by a professional who is
not qualified to address the specific fitness issue would be of
questionable validity. Therefore, the proposed prohibition would be
necessary to meet Goal 3 of this rulemaking, which is to improve the
effectiveness and efficiency of FFD programs, as well as Goal 7, which
is to
[[Page 50575]]
protect the privacy and due process rights of individuals who are
subject to Part 26.
Proposed Sec. 26.189(b)(1)-(b)(4) would list and present together
the circumstances in which a determination of fitness must be
performed, as required in other sections of the proposed rule. Although
this proposed paragraph would be redundant with other sections of the
proposed rule, these circumstances would be listed in the proposed
paragraph to meet Goal 6 of this rulemaking, which is to improve
clarity in the organization and language of the rule, by grouping
related requirements together in the order in which they would apply to
licensees' and other entities' FFD processes.
Proposed Sec. 26.189(b)(1) would reiterate the requirement in
current Section 2.9(f) in Appendix A to Part 26 and proposed Sec.
26.185(k) that a determination of fitness must be performed when there
is a medical explanation for a non-negative test result, but a
potential for impairment exists. For example, legitimate use of some
psychotropic medications or medications for pain relief may cause
impairment in some individuals and it may be necessary to limit the
types of tasks the individual performs until the medication is no
longer necessary, or the person adjusts to its effects.
Proposed Sec. 26.189(b)(2) would reiterate requirements in current
Sec. 26.27(b)(1) and (b)(4) and proposed Sec. 26.69(b) [Authorization
after a first confirmed positive drug or alcohol test result or a 5-
year denial of authorization] that a determination of fitness must be
performed before an individual is granted authorization following an
unfavorable termination or denial of authorization for a violation of a
licensee's or other entity's FFD policy.
Proposed Sec. 26.189(b)(3) would reiterate the requirement in
proposed Sec. 26.69(c) [Granting authorization with other potentially
disqualifying FFD information] that a determination of fitness must be
performed before an individual is granted authorization when
potentially disqualifying FFD information is identified that has not
been previously addressed and resolved under a Part 26 FFD program.
Proposed 26.189(b)(4) would address other circumstances in which a
determination of fitness may be required. For example, a determination
of fitness may be necessary if an FFD concern has been raised regarding
another individual, as required in proposed Sec. 26.27(c)(4), and if a
licensee's or other entity's reviewing official requires one, in
accordance with proposed Sec. 26.69(c)(3) and (d)(2).
Proposed Sec. 26.189(c) would be added to establish requirements
for a determination of fitness that is conducted ``for cause.''
Specifically, proposed Sec. 26.189(c) would require that a
determination of fitness that is conducted for cause must be conducted
through face-to-face interaction to ensure that the professional who is
performing the determination has available all of the sensory
information that may be required for the assessment, such as the smell
of alcohol or the individual's physical appearance. The immediacy of
the decision would limit the amount of information that could be
gathered and made available to the professional by others. Conversely,
the proposed paragraph would not require that determinations of fitness
for other purposes be conducted face-to-face. These other purposes may
include, but would not limited to, the determination of fitness that
would be required when an applicant for authorization has self-
disclosed potentially disqualifying FFD information. Determinations of
fitness in these other circumstances would focus primarily on
historical, rather than immediate, information. The professional would
have access to information that could be gathered by others about the
individual, and no time urgency would be involved in the evaluation.
Therefore, the proposed paragraph would be added to meet Goal 3 of this
rulemaking, which is to improve the effectiveness and efficiency of FFD
programs, by requiring a face-to-face assessment in some circumstances
where electronic means of communication could not provide the requisite
information for the evaluation, and permitting other means of
conducting the assessment when those means provide increased
flexibility to licensees and other entities while continuing to achieve
the goal of the evaluation.
Proposed Sec. 26.189(c)(1)-(c)(4) would be added to specify the
required outcomes of a for-cause determination of fitness. The proposed
rule would provide an increased level of detail in these requirements
to increase consistency in implementing the for-cause determination of
fitness process among FFD programs for the reasons discussed with
respect to proposed Sec. 26.187 [Substance abuse expert].
Proposed Sec. 26.189(c)(1) would require that, if there is neither
conclusive evidence of an FFD policy violation nor a significant basis
for concern that the individual may be impaired while on duty, then the
individual must be determined to be fit for duty and the licensee or
other entity must permit the individual to perform the job duties that
require the individual to be subject to this part.
Proposed Sec. 26.189(c)(2) would require that, if there is no
conclusive evidence of an FFD policy violation, but there is a
significant basis for concern that the individual may be impaired while
on duty, then the individual must be determined to be unfit for duty.
Such a determination would not constitute a violation of Part 26 or the
licensee's or other entity's FFD policy; therefore, no sanctions would
be applied. Examples of circumstances in which an individual may be
determined to be unfit under the proposed paragraph could include a
temporary illness, such as a severe migraine headache, or transitory
but severe stress in a personal relationship. These circumstances may
impact an individual's ability to work safely for a short period, but
would have no implications for the individual's overall fitness to
perform the job duties that require the individual to be subject to
this part. In addition, the proposed rule would require the
professional who conducts the determination of fitness to consult with
the licensee's or other entity's management personnel to identify and
implement any necessary limitations on the impaired individual's
activities to ensure that the individual's condition would not affect
workplace or public health and safety. If appropriate, the individual
may be referred to the EAP for assistance.
Proposed Sec. 26.189(d) would be added to prohibit licensees and
other entities from seeking a second determination of fitness if a
determination of fitness under Part 26 has already been performed by a
qualified professional who is employed by or under contract to the
licensee or other entity. The proposed paragraph would also require
that the professional who made the initial determination must be
responsible for modifications to the initial determination based on new
or additional information. If the initial professional is no longer
available, then the licensee or other entity would be required to
assist in arranging for consultation between the new professional and
the professional who is no longer employed by or under contract to the
licensee or other entity. The proposed paragraph would be necessary to
ensure consistency and continuity in the treatment of an individual who
may be undergoing treatment, aftercare, and followup testing.
[[Page 50576]]
Subpart I--Managing Fatigue
Section 26.195 Applicability
A new Sec. 26.195 [Applicability] would be added to specify the
licensees and other entities to whom the requirements in proposed
Subpart I would apply. Proposed Subpart I would apply only to licensees
who are authorized to operate a nuclear power reactor (under Sec.
50.57 of this chapter) and holders of a combined license after the
Commission has made the finding under Sec. 52.103 of this chapter, as
specified in proposed Sec. 26.3(a), and C/Vs who implement FFD
programs or program elements upon which such licensees rely, as
specified in proposed Sec. 26.3(d).
As discussed in Section IV. D, the proposed rule would require
nuclear power plant licensees to implement the requirements in Subpart
I for the following reasons:
(1) Fatigue and decreased alertness can substantively degrade an
individual's ability to safely and competently perform his or her
duties;
(2) Conditions that contribute to worker fatigue are prevalent in
the U.S. nuclear power industry;
(3) With the exception of NRC orders limiting the work hours of
security personnel, the NRC's current regulatory framework does not
include consistent requirements to prevent worker fatigue from
adversely impacting safe operations and enforcement of the current
requirements is complex;
(4) Reviews of nuclear power plant licensees' controls on work
hours have repeatedly identified practices that are inconsistent with
the NRC's Policy on Worker Fatigue, including excessive work hours and
the overuse of work-hour limit deviations;
(5) The current regulatory framework is comprised of requirements
that are inadequate and incomplete for effective fatigue management;
(6) Ensuring effective management of worker fatigue through
rulemaking would substantially enhance the effectiveness of FFD
programs, but additional orders are not presently warranted to ensure
adequate protection of public health and safety or the common defense
and security; and
(7) Preventing the fatigue of workers in safety-critical positions
through regulation is consistent with practices in foreign countries
and other industries in the U.S.
The proposed requirements also would apply to C/Vs who implement
FFD programs or program elements, to the extent that nuclear power
plant licensees rely upon those C/V FFD programs or program elements to
meet the requirements of this part. This proposed provision would
permit licensees to rely on a C/V's fatigue management program,
consistent with the permission for licensees to rely on licensee-
approved FFD programs and program elements in current Sec. 26.23(a),
as retained in proposed Sec. 26.3 [Scope].
Proposed Subpart I would not apply to the materials licensees who
are otherwise subject to Part 26 (see proposed Sec. 26.3 [Scope]) for
two reasons. First, NRC analyses have indicated that significant
offsite radiological exposure is not a realistic accident consequence
at a materials facility that is subject to Part 26 regulations because
of the nature of the radioactive materials that are involved and the
multiple layers of controls that are required under NRC regulations.
Second, there is no evidence of excessive overtime use by the materials
licensees who are subject to Part 26. Therefore, applying the
requirements in Subpart I to these licensees would be unnecessary. The
costs associated with establishing work hour controls to meet the
proposed Subpart I requirements would not be commensurate with a
corresponding benefit to the protection of public health and safety and
the environment. However, requirements to prevent fatigue from
adversely affecting the job performance of security personnel at
materials facilities may provide a substantial enhancement to the
security of these facilities. In SRM-COMSECY-04-0037, dated September
1, 2004, the Commission determined that FFD enhancements related to the
fatigue of security force personnel at Independent Spent Fuel Storage
Installations, Decommissioning Reactors, Category I Fuel Cycle
Facilities, Gaseous Diffusion Plants, and the Natural Uranium
Conversion Facility should be pursued as a separate rulemaking activity
with additional stakeholder interactions. That activity is scheduled to
begin in FY 2006. Publication of a proposed rule related to fatigue of
security forces for these materials facilities would not occur until
the final rule is published from this rulemaking.
Section 26.197 General Provisions
Proposed Sec. 26.197 [General provisions] would be added to
establish fatigue management requirements for licensees' FFD programs.
The general provisions in this section would establish requirements for
licensees' fatigue management policies, procedures, training,
examinations, recordkeeping, and reporting. The NRC's objective in
establishing these general provisions would be to facilitate
integrating fatigue management into licensees' FFD programs, as
discussed in Section IV. D.
Proposed Sec. 26.197(a) [Policy] would be added to require each
licensee to have a written policy statement that describes its
management's expectations and methods for managing fatigue to ensure
that fatigue does not adversely affect any individual's ability to
safely and competently perform his or her duties. The NRC believes that
the responsibility for ensuring that each individual is fit to safely
and competently perform his or her duties is shared between the
licensee and the individuals who perform duties on the licensee's
behalf. Therefore, the proposed rule would require each licensee's FFD
policy to set forth the licensee's fatigue management policy, so that
individuals who are subject to it will be aware of and may comply with
the fatigue management requirements for which they will be held
accountable. The proposed rule would require each licensee to
incorporate the fatigue management policy statement into the written
FFD policy that would be required under proposed Sec. 26.27(b). As
discussed with respect to proposed Sec. 26.27(b), the proposed rule
would require the policy statement to be clear, concise, and readily
available, in its most current form, to all individuals who are subject
to the policy.
The NRC's past experience with worker fatigue, such as that
documented in NRC Regulatory Issue Summary (RIS) 2002-007,
Clarification of NRC Requirements Applicable to Worker Fatigue and
Self-declarations of Fitness-For-Duty, dated May 10, 2002, (referred to
in this document as RIS 2002-007), indicates that there is a need for
individuals to clearly understand their fatigue management
responsibilities and those of the licensee. These responsibilities
would include the individual's responsibility to report FFD concerns,
including concerns related to the impact of fatigue on the individual's
ability to safely and competently perform his or her job duties, as
well as concerns related to others, and the licensee's responsibility
to assess such fatigue-related FFD concerns. Further, the proposed rule
would not prohibit licensees from imposing sanctions on individuals for
failing to comply with the portions of the licensees' fatigue
management policies that assign certain responsibilities to
individuals. For example, some licensees may impose sanctions on an
individual who fails to seek recommended treatment for a sleep disorder
that, as part of a determination of fitness performed in accordance
with proposed Sec. 26.189 [Determination of fitness], a healthcare
professional has
[[Page 50577]]
determined is adversely affecting the individual's job performance and
potentially could be medically resolved. The proposed rule would not
establish minimum sanctions for individual failures to comply with such
fatigue management requirements because the reasons that an individual
may report to work in a fatigued state are varied and often highly
personal. Rather, the NRC prefers to permit licensees and the
appropriate healthcare professionals to respond to such circumstances
on a case-by-case basis. However, in order to protect individuals'
rights to due process under the rule, it would be necessary for
licensees' fatigue management policies to communicate any sanctions
that a licensee may impose on an individual for failing to comply with
the policy's requirements.
Proposed Sec. 26.197(b) [Procedures] would be added to require
licensees to develop, implement, and maintain procedures to implement
the fatigue management policy that would be required under proposed
Sec. 26.197(b). Procedures would be necessary to ensure that
licensees' fatigue management programs are properly and consistently
implemented.
Proposed Sec. 26.197(b)(1) would require licensees to develop,
implement, and maintain procedures that describe the process to be
followed any time an individual who is subject to the licensee's FFD
program reports to a supervisor that he or she is unfit for duty
because of fatigue (i.e., makes a self-declaration). The NRC previously
noted in RIS 2002-007 that self-declaration is an important adjunct to
behavioral observation in meeting the requirements of the performance
objective in current Sec. 26.10(b) [as retained in proposed Sec.
26.23(c)], which is ``to provide reasonable measures for the early
detection of persons who are not fit to perform the job duties that
require them to be subject to this part.'' Because individuals are the
first line of defense against the potential for fatigue-related
impairment to adversely affect their job performance, it is essential
that all individuals who are subject to a licensee's FFD program
understand when and how to make a self-declaration that they are unfit
for duty. Individuals must also understand how the licensee's response
to a worker's self-declaration will differ from a licensee's response
to an individual's general statement of fatigue (e.g., casually
commenting to a co-worker, ``I'm really tired today''), if the
individual does not express a concern that is specific to his or her
fitness for duty (e.g., formally stating to a supervisor, ``I am too
tired right now to check these valve lineups accurately'').
Proposed Sec. 26.197(b)(1)(i) would require the licensee's self-
declaration procedure to describe the responsibilities of individuals
and licensees and the actions they must take with respect to an
individual's self-declaration of fatigue. The NRC has considered
industry experience with individuals refusing to report to work on the
basis that they were too tired, and has concluded that detailed
procedures are necessary to specify: (1) The individual's
responsibility to be available at work for a fatigue assessment, which
must be conducted face-to-face under proposed Sec. 26.201(b) for the
reasons discussed with respect to that paragraph; (2) the individual's
responsibility to cooperate with the fatigue assessment process by
providing the necessary information [see the discussion of proposed
Sec. 26.201(c)(2)]; and (3) the licensee's responsibility for
conducting a fatigue assessment in response to an individual's self-
declaration, as required under proposed Sec. 26.201(a)(2), to
determine whether, and under what controls and conditions, if any, the
individual may be permitted or required to work.
Proposed Sec. 26.197(b)(1)(ii) would require the licensee's self-
declaration procedure to describe requirements for establishing
controls and conditions under which an individual may be permitted or
required to perform work after that individual declares that he or she
is not fit for duty as a result of fatigue. This portion of the
procedure would be necessary to ensure correct and consistent
implementation of the requirements in proposed Sec. 26.201(b), which
would require that a supervisor or staff member of the FFD program must
conduct the fatigue assessment and make a determination whether, and
under what conditions, an individual who has self-declared may be
returned to duty. For example, the licensee's procedure would provide
guidance on establishing appropriate controls and conditions under
which an individual could be permitted or directed to return to work
after declaring that he or she is unfit because of fatigue. Controls
and conditions may include, but would not be limited to: (1) Controls
on the type of work to be performed (e.g., physical or mental, tedious
or stimulating, individual or group, risk-significant or not); (2) the
required level of supervision (continuous or intermittent) and other
oversight (e.g., peer checks, independent verifications, quality
assurance reviews, and operability checks); and (3) the need to
implement fatigue countermeasures (e.g., naps, rest breaks). The
purpose of the controls and conditions would be to mitigate the risks
to public health and safety or the common defense and security that a
fatigue-induced human error could pose, as discussed in Section IV. D.
Proposed Sec. 26.197(b)(1)(iii) would be added to require licensee
procedures to describe the processes to be followed if an individual
disagrees with the results of a fatigue assessment that was conducted
in response to the individual's self-declaration. These procedures
would address situations in which the individual disagrees with the
licensee's determination either that the individual is capable of
performing work safely (with appropriate controls and conditions, if
necessary) or that the individual cannot safely be permitted to perform
the job duties listed in proposed Sec. 26.199(a) because of fatigue.
For example, the licensee's procedure may refer an individual who
disagrees with the outcome of the fatigue assessment to the bargaining
unit to initiate a grievance process, the employee concerns program, or
the corrective action program.
The proposed rule would add this requirement for several reasons.
First, in RIS 2002-007, the NRC documented concerns associated with
past instances of self-declaration. The NRC believes that these
instances indicated the need for licensees to describe the processes to
be followed if an individual disagrees with the results of a fatigue
assessment following a self-declaration. In addition, at the public
meetings discussed in Section V, several stakeholders requested that
this provision be added to the proposed rule to ensure that individuals
have recourse if they disagree with the results of a fatigue assessment
that was conducted in response to a self-declaration. Some of the
stakeholders expressed a concern for the potential impact on public
health and safety if an individual is convinced that he or she is too
fatigued to perform work safely but the licensee requires the
individual to work. Other stakeholders expressed concerns that an
individual may experience adverse employment and financial consequences
if he or she is prevented from working because of fatigue.
The NRC concurs that licensee policies and procedures related to
implementing the requirements of this proposed subpart must address
these potential issues in order to protect the due process rights of
individuals who would be subject to the rule. However, the proposed
rule would not establish specific requirements for the process(es) to
be followed in such instances for two reasons: (1) Licensees have
already
[[Page 50578]]
implemented a number of processes for addressing similar safety and
employment issues that provide appropriate mechanisms for resolving
fatigue-related issues, and (2) there is such a wide variety of
possible issues that may arise that establishing one mechanism in the
proposed rule could not be expected to appropriately address them all.
Therefore, the proposed rule would require licensees to have procedures
for addressing situations in which an individual who has self-declared
disagrees with the outcome of a fatigue assessment, but would not
require a new process nor specify the required characteristics of the
process(es) the licensees would use.
Proposed Sec. 26.197(b)(2) would be added to require that licensee
procedures must describe the process for implementing the work hour
controls that would be required under proposed Sec. 26.199 [Work hour
controls]. For example, the procedures would detail individual and
organizational responsibilities and requirements, including items such
as: Scheduling; tracking and calculating work hours; granting waivers
of the individual work hour controls; reviewing the implementation of
the work hour controls; documenting the results of the reviews; and
implementing any necessary corrective actions. These procedures would
be necessary to ensure that individuals understand the work hour
controls to which they are subject and that licensees consistently
implement the work hour controls required in proposed Sec. 26.199 and
as the NRC intends.
Proposed Sec. 26.197(b)(3) would be added to require that licensee
procedures must describe the process(es) to be followed in conducting a
fatigue assessment, as required under proposed Sec. 26.201(a). The
proposed procedures would establish the methods through which the
licensee would determine whether an individual who may be fatigued will
be permitted or required to perform work and whether controls and
conditions are necessary for the individual to be able to perform work
safely and competently. The licensee's procedure would address fatigue
assessments that are conducted following an individual's self-
declaration, an event, for cause, or to reassess an individual after
returning the individual to work despite a self-declaration of fatigue
[the situations in which the proposed rule would require licensees to
conduct fatigue assessments are discussed with respect to proposed
Sec. 26.201(a)]. Because of the potentially subjective and personal
nature of the fatigue assessment task and the potential for conflict
and sanctions (e.g., if an individual is determined to have been asleep
while on duty), comprehensive procedures would be necessary to ensure
consistent implementation of the fatigue assessment requirements in
proposed Sec. 26.201 [Fatigue assessments]. Therefore, the NRC expects
that these procedures would describe measures to ensure that fatigue
assessments: (1) Are performed by properly trained personnel; (2) are
free of bias; (3) methodically address the factors that commonly
contribute to fatigue; (4) are based on complete and accurate
information; (5) protect the privacy of the individuals being assessed;
(6) recognize the fact that an individual may be fatigued and unfit for
duty even though he or she has not exceeded the work-hour limits; (7)
are thoroughly documented; and (8) are reviewed, as required by
proposed Sec. 26.199(j)(1). These procedures would be necessary to
implement the proposed requirements in this subpart and protect the due
process and privacy rights of individuals, consistent with Goal 7 of
this rulemaking.
Proposed Sec. 26.197(b)(4) would be added to require licensees to
describe in a procedure the sanctions they may impose on individuals,
if any, following a fatigue assessment (e.g., termination or leave
without pay). During the public meetings discussed in Section V,
several industry representatives indicated that licensees may rely upon
the results of a fatigue assessment as the basis for determining that
an individual has not met management expectations for maintaining his
or her fitness for duty. Although the NRC neither endorses nor
prohibits the imposition of sanctions in cases of fatigue, licensees
have an obligation to provide due process to individuals who are
subject to their FFD policy. For this reason, procedures would be
necessary to ensure that licensees fully disclose the conditions under
which sanctions would be considered; the nature of the possible
sanctions; and the process for administering and imposing the
sanctions, including management's expectations and the individual's
right to a review of the determination that he or she has violated the
FFD policy, as required under proposed Sec. 26.39 [Review process for
fitness-for-duty policy violations].
Proposed Sec. 26.197(c) [Training and examinations] would
establish additional fatigue-related training and examination
requirements, in addition to those required under proposed Sec.
26.29(a) and (b). Several of the knowledge and abilities (KAs)
requirements that are listed in proposed Sec. 26.29(a) would ensure
that individuals are familiar with a licensee's or other entity's
fatigue policies and procedures, which may include the consequences of
violating them under proposed Sec. 26.29(a)(1), and individuals' and
others' responsibilities under the licensee's FFD program in proposed
Sec. 26.29(a)(2) and (a)(3). However, individuals who would be subject
to Subpart I should also have a working-level knowledge of specific,
fatigue-related topics that may facilitate personal decisions and
actions that are consistent with the objective of preventing,
detecting, and mitigating the adverse effects of fatigue on worker job
performance. Individual workers typically do not possess these KAs
without training (Folkard and Tucker, 2003; Knauth and Hornberger,
2003; Monk, 2000). Therefore, the proposed rule would require licensees
to address the topics specified in proposed Sec. 26.197(c)(1) and
(c)(2) in their FFD training and testing programs.
Proposed Sec. 26.197(c)(1) would require FFD training and
examinations to ensure that individuals who are subject to the proposed
subpart understand the contributors to worker fatigue, circadian
variations in alertness and performance, indications and risk factors
for common sleep disorders, shiftwork strategies for obtaining adequate
rest, and the effective use of fatigue countermeasures. Examples of
topics that licensee training and examinations would address that are
related to this KA would include, but are not limited to: (1) The
principal factors that influence worker fatigue; (2) knowledge that a
worker's ability to perform and remain alert is influenced by
physiological changes that follow a daily pattern; (3) the time periods
during which workers are most likely to exhibit degraded alertness and
performance; (4) the principal symptoms of common sleep disorders
(e.g., sleep apnea and insomnia) and the conditions that can contribute
to their onset; (5) the methods for optimizing sleep periods on a
shiftwork schedule; and (6) how to safely and effectively counteract
fatigue with measures such as caffeine and strategic napping. Knowledge
of these topics is necessary to ensure that individuals are able to:
(1) Self-manage fatigue that is caused by shiftwork and factors other
than work hours; (2) take actions to maintain their alertness at work;
and (3) recognize and seek treatment for sleep disorders that might be
creating or exacerbating their own fatigue. In addition, training in
methods for coping with the challenges of shiftwork may contribute to a
more
[[Page 50579]]
stable workforce by reducing worker turnover. A survey by Circadian
Technologies Incorporated of 550 facilities in the U.S. and Canada
found that turnover at facilities with operations extending beyond 7
a.m. to 7 p.m. averaged 10 percent in 2003, compared with 3.4 percent
in all U.S. companies. Facilities offering no training on specific
coping strategies had an average turnover rate of 11.4 percent,
compared to 7.6 percent for facilities that offered such training to
their employees, and 2.9 percent for those offering the training to
employees and their family members (Circadian Technologies
Incorporated, 2004).
Proposed Sec. 26.197(c)(2) would require FFD training and
examinations to ensure that individuals who are subject to proposed
Subpart I have the ability to identify symptoms of worker fatigue and
contributors to decreased alertness in the workplace. Examples of
topics that are related to this KA would include, but are not limited
to: (1) Behavioral symptoms of fatigue (e.g., yawning, red-eyes,
prolonged or excessive blinking, irritability); (2) task conditions
that may contribute to degraded alertness and increased fatigue (e.g.,
repetitive tasks, tasks with high cognitive or attentional demands,
tasks that require the individual to be sedentary, tasks that limit
social interaction); and (3) environmental conditions that may
contribute to degraded alertness and increased worker fatigue (e.g.,
high heat and humidity, low lighting, and low frequency noise/white
noise). Requiring individuals to be trained on this KA would be
necessary to ensure that an individual is able to determine when it is
appropriate to self-declare that he or she is unfit for duty because of
fatigue, as permitted under proposed Sec. Sec. 26.199(e) and
26.201(a)(2), and identify other individuals who are exhibiting
indications of fatigue through behavioral observation to determine when
it is appropriate to report an FFD concern about another individual, as
required under proposed Sec. 26.33 [Behavioral observation].
Proposed Sec. 26.197(d) [Recordkeeping] would be added to
establish recordkeeping requirements related to the implementation of
proposed Subpart I. Specifically, proposed Sec. 26.197(d)(1) would
require licensees to retain records of the number of hours worked by
individuals who are subject to the work hour controls established in
proposed Sec. 26.199 [Work hour controls]; proposed Sec. 26.197(d)(2)
would require licensees to retain records of the number of waivers they
have granted and the bases for those waivers; proposed Sec.
26.197(d)(3) would require licensees to retain documentation of the
work hour reviews that would be required under proposed Sec.
26.199(j)(3); proposed Sec. 26.197(d)(4) would require retaining
documentation of any fatigue assessments that would be conducted, as
required by proposed Sec. 26.201(g); and proposed Sec. 26.197(d)(5)
would require licensees to retain documentation of each job duty
group's collective work hours. The proposed rule would establish these
recordkeeping requirements for four reasons: (1) These records would be
necessary to ensure that documentation of the licensee's fatigue
management program is retained and available for NRC inspectors to
verify that licensees are complying with the proposed work hour
controls, and waiver and fatigue assessment provisions; (2) the
documentation may be necessary for a review process under proposed
Sec. 26.39 [Review process for fitness-for-duty policy violations] or
in legal proceedings related to a determination that an individual has
violated the fatigue provisions of an FFD policy; (3) the documentation
would be necessary to perform the trending and self-assessments that
would be required under proposed Sec. 26.199(j) [Reviews]; and (4) the
documentation would be necessary to meet the reporting requirements in
proposed Sec. 26.197(e) [Reporting]. In order to ensure that the
records remain available for NRC inspections and for the review process
or legal proceedings, the proposed paragraph would require licensees to
retain these records for 3 years or until the completion of any related
legal proceedings, whichever is later.
Proposed Sec. 26.197(e) [Reporting] would be added to require
licensees to report to the NRC certain data related to their fatigue
management programs as part of the annual FFD program performance
report, which licensees would be required to submit under proposed
Sec. 26.217 [Fitness-for-duty program performance data]. The proposed
rule would require licensees to include the following information in
the annual report: (1) Information on the number of waivers granted
from work hour controls from the previous calendar year; (2) the
collective work hours for any job duty group whose average work hours
exceeds 48 hours per week; and (3) the number of fatigue assessments
conducted during the year, the management actions that resulted, and
the conditions under which the fatigue assessments were conducted. The
NRC would use the information in these annual reports for several
purposes.
The primary reason for requiring licensees to submit this
information annually would be that, as discussed in Section IV. D,
certain nuclear power plant licensees have permitted individuals to
work hours that are significantly in excess of those intended under the
NRC's Policy on Worker Fatigue and abused the waiver provisions of the
Policy by granting blanket waivers to large groups of plant personnel
for extended periods of time. It is the intent of the requirements in
proposed Subpart I to ensure that such abuses do not recur under the
proposed rule. However, the NRC does not have the resources to inspect
every licensee's fatigue management program each year and collect this
information by relying solely on NRC inspection personnel. Therefore,
the proposed requirement for licensees to submit this information would
be necessary to ensure that it would be available for the NRC's review
and evaluation to identify licensees whose fatigue management programs
do not appear to be meeting the objectives of this proposed subpart.
In addition, the proposed reports would permit the NRC to more
efficiently focus its inspection resources on those licensees' fatigue
management programs that do not appear to be meeting the objectives of
this proposed subpart, and thereby maximize the efficiency of the
inspection process. Obtaining information about significant fatigue-
management issues and events (e.g., events resulting in fatigue
assessments, or plant events occurring while work hour limits are
waived) would permit the NRC to evaluate situations that may indicate
inadequate licensee performance. Inadequate licensee performance may
require action by the NRC staff to ensure that public health and safety
and the common defense and security are not compromised.
The NRC also requires the information to: (1) Track the
effectiveness of the requirements of proposed Subpart I in controlling
the fatigue of nuclear power plant workers; (2) assess whether the
objectives of the proposed requirements are being achieved; and (3)
determine whether any further changes to the requirements are necessary
to ensure that worker fatigue is managed consistent with the intent of
the provisions. As a hypothetical example, if analyses of the data
obtained from the annual reports show that, across the industry, (1)
licensees generally grant significantly more waivers for operations
personnel than any other job duty groups, (2) operations job duty
groups exceed the 48-hour per person per week work
[[Page 50580]]
group average limit significantly more often than any other job duty
groups, and (3) operations personnel are subject to more for-cause
fatigue assessments than individuals in any other work groups, the NRC
may determine that it is necessary to further evaluate the causes for
these findings and potentially revise the requirements of Subpart I as
they relate to the operations job duty group.
In summary, because the information that licensees would be
required to report would be central to assessing licensee performance,
efficiently allocating NRC inspection resources, and evaluating the
effectiveness of the proposed Subpart I requirements, the reporting
burden that these requirements would impose on licensees is warranted.
However, the NRC expects that the additional burden associated with the
proposed requirements for licensees to add this information to their
annual reports would be minimal because proposed Sec. 26.199(j)
[Reviews] would require licensees to aggregate and review this
information after each averaging period for the reasons discussed with
respect to that proposed provision. Therefore, the proposed requirement
to include the information in the annual FFD program performance report
would not impose a significant additional burden.
Proposed Sec. 26.197(e)(1) would require licensees to provide the
NRC with an annual summary of the number of instances during the
previous calendar year in which the licensee waived each of the work
hour controls specified in proposed Sec. 26.199(d)(1) and (d)(2) for
each of the job duty groups listed in proposed Sec. 26.199(a).
(Waivers of the work hour controls in proposed Sec. 26.199(d)(1) and
(d)(2) would be permitted under proposed Sec. 26.199(d)(3) for the
reasons discussed with respect to proposed Sec. 26.199(d)(3).) For
example, if a licensee granted 10 waivers to one operator that
permitted him or her to work 18 hours in a 24-hour period [see proposed
Sec. 26.199(d)(1)(i)] on 10 separate occasions during the calendar
year, the licensee would report that the work hour limit in proposed
Sec. 26.199(d)(1)(i) was waived 10 times in the operations job duty
group that year. The job duty groups who would be subject to work hour
controls are discussed with respect to proposed Sec. 26.199(a).
Similarly, if the licensee granted one waiver to each of 10 different
operators to permit the operators to work 18 hours in a 24-hour period,
the licensee would also report that the work hour limit in proposed
Sec. 26.199(d)(1)(i) was waived 10 times in the operations job duty
group that year. As another example, if the licensee permitted an
operator to work 18 hours in a 24-hour period three times in a year,
another operator to work 80 hours in a 7-day period, and another
operator to take a rest break of only 6 hours between shifts, then the
licensee would report that the operations job duty group was granted
three waivers of proposed Sec. 26.199(d)(1)(i), one waiver of proposed
Sec. 26.199(d)(1)(iii), and one waiver of proposed Sec.
26.199(d)(2)(i) for the year.
As a fourth and more complex example, if a licensee permitted an
operator who normally works 12-hour shifts to work a seventh 12-hour
consecutive shift, followed by a second waiver on the eighth day to
work another 12-hour shift, then the licensee would report multiple
waivers. In this example, on the seventh day, the licensee would grant
one waiver of proposed Sec. 26.199(d)(1)(iii) for working 84 hours in
a 7-day period and one waiver of proposed Sec. 26.199(d)(2)(ii) for
not receiving the required 24-hour break in a 7-day period. On the
eighth day, the individual would be granted those same two waivers
again. So, the licensee would report the instances on the seventh and
eighth days as two waivers of proposed Sec. 26.199(d)(1)(iii) and two
waivers of proposed Sec. 26.199(d)(2)(ii). This example presumes that
the individual received the 48-hour break required by proposed Sec.
26.199(d)(2)(iii) within the 6 days preceding day 1, otherwise
additional waivers from that provision would also be required and
reported.
The proposed rule would also establish additional requirements
related to aggregating and reporting the waiver data, as follows:
Proposed Sec. 26.197(e)(1)(i) would require licensees to include
in the annual report only those waivers under which work was actually
performed. The proposed rule would add this provision because it may
sometimes be unnecessary for individuals to work the extended hours for
which a licensee planned when granting a waiver. Licensees may
anticipate that it will be necessary to waive one or more work hour
control in proposed Sec. 26.199(d)(1) and (d)(2) in order to complete
a task, and so implement the process specified in proposed Sec.
26.199(d)(3) for granting waivers. However, on some occasions, the work
will be finished sooner than the licensee anticipated, with the result
that the waiver was granted but no-one was required to work an extended
work period. The proposed rule would require licensees to exclude
waivers under which no work was performed from the annual report
because the granting of a waiver provides would provide no meaningful
information about the licensee's management of fatigue during extended
work periods.
In addition, proposed Sec. 26.197(e)(1)(ii) would require
licensees to report all waivers granted of each of the work hour
controls in proposed Sec. 26.199(d)(1) and (d)(2) for each job duty
group, to include all of the waivers that were granted for those
instances in which a single extended work period required waiving more
than one of the work hour controls. For example, if a component failure
creates a condition adverse to safety, the licensee may determine that
a waiver of the work hour controls for a four-person crew of
maintenance technicians would be necessary to resolve the adverse
safety condition in a timely manner. Assuming that the results of
fatigue assessments of the individuals involved indicated that they
were able to continue working, the licensee may decide to waive two of
the limits on individual work hours in proposed Sec. 26.199(d)(1) for
each of four crew members to enable them to complete the repair.
Therefore, depending upon the actual circumstances, proposed Sec.
26.199(e)(1)(ii) would require the licensee's annual summary to report,
for example, that waivers were granted to four maintenance technicians
of the ``16 work hours in any 24-hour period'' individual work hour
limit in proposed Sec. 26.199(d)(1)(i) as well as four waivers of the
``26 work hours in any 48-hour period'' requirement in proposed Sec.
26.199(d)(1)(ii). Although the maintenance crew may have worked for
only a single extended work period, the licensee's annual summary would
include all eight of the waivers that the licensee would grant in this
example.
The waiver data that licensees would be required to report to the
NRC under proposed Sec. 26.197(e)(1)(i) and (e)(1)(ii) would be
important because waivers represent ``assumed risk.'' For example, as
discussed in Section IV. D, fatigued workers have impaired cognitive
functioning, including difficulties in maintaining attention and
alertness. If a licensee permits an individual to work extended hours
that cause the individual to become fatigued, the individual may
experience momentary lapses in attention or degraded decision-making
from fatigue that could cause him or her to commit errors that may pose
risks to public health and safety and the common defense and security.
These performance degradations can be mitigated by establishing
controls and conditions under which the individual is permitted to
work, as would be required under proposed Sec. 26.201(e). However,
controls and conditions
[[Page 50581]]
cannot eliminate errors altogether and would reduce, but not eliminate,
the potential risks to public health and safety or the common defense
and security from fatigue-induced errors. The more often that a
licensee permits individuals to exceed work hour limits, the more risk
from fatigue-induced errors that a licensee would be assuming. The risk
of fatigue-induced errors increases further when an individual is
permitted to exceed more than one of the work hour limits in proposed
Sec. 26.199(d)(1)(i)-(d)(1)(iii) because of the potential for combined
effects of both acute and cumulative fatigue. Any waivers from the rest
breaks that would be required under proposed Sec. 26.199(d)(2)(i)-
(d)(2)(iii) would also contribute to the accumulation of a sleep
deficit, especially when inadequate rest breaks are combined with long
work hours. Repeated and continual use of waivers may indicate a
staffing or other programmatic weakness at a site that warrants
additional inspection resources. Therefore, the NRC considers the
number of waivers granted from the work hour limits to be a key element
of FFD program performance.
During the September 14, 2004 public meeting, NEI commented that
the number of waivers granted would not give meaningful information
about the health of a licensee's program. However, as discussed in
Section IV. D, certain nuclear power plant licensees have granted
thousands of waivers each year under the current Policy on Worker
Fatigue. This level of waiver use is inconsistent with the intent of
the NRC's Policy and provides a clear indication that these licensees
have not been effectively managing fatigue. If a licensee continued to
grant thousands of waivers each year under the requirements of this
proposed subpart, the sheer number of waivers granted in this case
would provide meaningful information about the licensee's fatigue
management program as well as the effectiveness of these proposed
requirements. In less extreme circumstances, the NRC concurs that a
simple summary of the number of waivers granted during the year would
not provide sufficient information for the NRC to evaluate a licensee's
practices with respect to granting waivers. It is for this reason that
the proposed rule would require licensees to report additional
information about their fatigue management practices in the annual
summary report under proposed Sec. 26.197(e)(2) and (e)(3) to provide
the contextual information necessary to properly interpret the waiver
data that proposed Sec. 26.197(e)(1) would require. When considered in
conjunction with number of instances in which collective work hour
limits [in proposed Sec. 26.197(e)(2)] are exceeded and the number of
fatigue assessments that a licensee conducts each year and their
outcomes [in proposed Sec. 26.197(e)(3)], the number of waivers
granted in a year provides an important indicator of the health of the
licensee's fatigue management program. Therefore, the proposed
requirement for licensees to report the number of waivers granted each
year would be necessary to: (1) Evaluate the effectiveness of the more
stringent requirements for granting waivers in proposed Sec.
26.199(d)(3), which will be discussed further with respect to that
paragraph; and (2) monitor the ongoing effectiveness of licensees'
fatigue management programs, when considered together with the other
information that licensees would be required to report in this proposed
paragraph.
Proposed Sec. 26.197(e)(2) would be added to require licensees to
report the collective work hours of any job duty group listed in
proposed Sec. 26.199(a) that exceeded the applicable collective work
hour limits in any averaging period during the previous calendar year
under the conditions specified in proposed Sec. 26.199(f)(3) and
(f)(5). As discussed with respect to proposed Sec. 26.199(f)(3), the
proposed rule would permit a job duty group's collective work hours to
exceed 48 hours per person per week during one averaging period if all
of the following conditions are met: (1) The circumstances that caused
the group's collective work hours to exceed 48 hours per person per
week could not be reasonably controlled; (2) the group's collective
work hours did not exceed 54 hours per person per week; and (3) the
additional work hours were worked only to address the circumstances
that the licensee could not have reasonably controlled. Proposed Sec.
26.199(f)(5) would also permit licensees to exceed any of the
collective work hour limits in proposed Sec. 26.199(f), if the
licensee receives prior approval from the NRC of a written request to
exceed the work hour limits.
Proposed Sec. 26.197(e)(2) would require licensees to report the
collective work hours of any job duty group whose collective work hours
exceeded the specified collective work hour limits during the previous
year because this information would be necessary for the NRC to monitor
the effectiveness of licensees' ongoing compliance with the proposed
collective work hour limits that would be established in proposed Sec.
26.199(f) [Collective work hour limits]. The number of times that
collective work hour limits are exceeded in a year would be indicative
of a licensee's effectiveness in managing the fatigue of its workers
who would be subject to the proposed requirements of proposed Sec.
26.199. Exceeding the collective work hour limits on repeated occasions
may indicate a programmatic weakness that would necessitate further NRC
inspection activities to address questions related to, for example, the
adequacy of licensee staffing within specific job duty groups, overall
management of cumulative fatigue, or corrective actions for fatigue
management weaknesses. Collectively, information concerning instances
in which collective work hour limits are exceeded, in conjunction with
information concerning the number of waivers granted [in proposed Sec.
26.197(e)(1)] and the number of fatigue assessments that a licensee
conducts each year and their outcomes (in proposed Sec. 26.197(e)(3)),
provide a strong indicator of the health of the licensee's fatigue
management program.
The NRC believes that the additional burden of including these
instances in the annual report to be minimal, as the intent of the
provisions is that the collective work hour limits in proposed Sec.
26.199(f) would be exceeded only under very infrequent circumstances.
Further, the NRC considers the burden to be significantly outweighed by
the need to effectively use NRC inspection resources. The proposed
paragraph would limit the reporting of occasions on which a job duty
group exceeds collective work hour limits to those specified in
proposed Sec. 26.199(f)(3) and (f)(5) because the proposed rule would
establish other reporting requirements for other instances in which a
job duty group's collective work hours may exceed the proposed
collective work hour limits, as discussed further with respect to the
relevant provisions.
Proposed Sec. 26.197(e)(3) would be added to require that
licensees include in the annual report the number of fatigue
assessments conducted, the conditions under which each assessment was
conducted [i.e., whether the assessment was conducted for-cause, for a
self-declaration, post-event, or as a followup, as described in
proposed Sec. 26.201(a)(1)-(a)(4)], and the management actions that
resulted from each assessment. The NRC considers that the reporting of
the fatigue assessments and their outcomes is similar to the reporting
of drug and alcohol tests results, which is also a part of the annual
report. For example, the NRC views the number of for-cause drug and
alcohol tests that a licensee
[[Page 50582]]
conducts each year to be one indicator of the health of the licensee's
behavioral observation program and its effectiveness in meeting the
rule's performance objective, in proposed Sec. 26.23(c), to provide
for the early detection of individuals who are not fit to perform the
job duties that require them to be subject to this part. The NRC would
similarly view the number of for-cause fatigue assessments that a
licensee conducts each year to be one factor indicating the health of
the licensee's behavioral observation and self-declaration processes
with respect to fatigue.
Collectively, the reporting of waivers that would be required in
proposed Sec. 26.197(e)(1), the number of instances in which a
licensee exceeds the 48-hour per person collective work hour limit that
would be required in proposed Sec. 26.197(e)(2), and the number of
fatigue assessments conducted and their outcomes that would be required
in Sec. 26.197(e)(3), would provide important information concerning
the effectiveness of fatigue management at a licensee site. Together,
the proposed reports would permit the NRC to: (1) Efficiently monitor
the ongoing effectiveness of licensees' fatigue management programs by
providing interpretable data; (2) efficiently allocate inspection
resources; (3) track the effectiveness of the requirements of proposed
Subpart I in controlling the fatigue of nuclear power plant workers;
(4) assess whether the objectives of the proposed rule are being
achieved; and (5) determine whether any further changes to the
requirements would be necessary to ensure that worker fatigue is
managed consistent with the intent of the provisions.
Section 26.199 Work Hour Controls
Proposed Sec. 26.199 [Work hour controls] would be added to
establish controls on the work hours of select individuals who are
subject to nuclear power plant licensees' FFD programs, as follows:
Proposed Sec. 26.199(a) [Individuals subject to work hour
controls] would be added to establish the scope of individuals who
would be subject to the work hour controls in proposed Sec. 26.199.
These individuals would be subject to the proposed work hour controls,
in addition to the proposed training, behavioral observation, and self-
declaration requirements of Subpart I that would apply to all
individuals who are subject to nuclear power plant licensees' FFD
programs. In determining the scope of personnel who would be subject to
the proposed work hour controls, the NRC considered the burdens on
individuals and licensees associated with the practical control of work
hours in conjunction with the potential for individuals' work
activities to affect public health and safety or the common defense and
security if their performance is degraded by fatigue. The NRC also
considered the nature of these individuals' work activities and work
environments relative to their potential to induce or exacerbate
fatigue (e.g., whether the work is monotonous or the environment is not
stimulating), the risk significance of the work, and the potential for
other controls to prevent or mitigate the consequences of a fatigue-
related error. As a result of these deliberations, the proposed rule
would require that individuals who perform the types of job duties
specified in proposed Sec. 26.199(a)(1)-(a)(5) must be subject to the
proposed work hour controls.
Proposed Sec. 26.199(a)(1) would require that individuals who
operate or provide onsite direction of the operation of systems and
components that ``a risk informed evaluation process has shown to be
significant to public health and safety'' must be subject to the
proposed work hour controls in this section. In order to implement the
proposed work hour controls, nuclear power plant licensees would be
required to delineate the operations personnel who would be subject to
the proposed work hour controls, based upon the risk significance of
the safety systems and components (SSCs) being operated, including, at
a minimum, personnel who are performing activities on SSCs that are
determined to be significant to public health and safety. To delineate
the scope of the operations job duty group, licensees could use, for
example, the risk significance determination process and criteria that
they currently use to meet the requirements of Sec. 50.65(a)(4) of
this chapter for assessing and managing the risk associated with
maintenance activities. The work hour controls of proposed Sec. 26.199
would typically apply to individuals who are operating or directing,
while on site, the operation of SSCs that are included within the scope
of an assessment required by Sec. 50.65(a)(4). Therefore, the proposed
work hour controls would apply to the individuals who most directly
affect the operation of SSCs that are most important to the protection
of public health and safety. Controlling the work hours of these
individuals would achieve the NRC's objective to minimize the potential
for fatigue-related errors in operating these risk-significant SSCs.
Licensed operators, who perform the job duties specified in
proposed Sec. 26.199(a), are responsible for correctly performing
actions that are necessary for the safe operation of nuclear power
plants and the mitigation of accidents at these facilities. These
responsibilities include monitoring the plant for off-normal conditions
and taking appropriate actions to prevent these conditions from
challenging the reactor core, safety systems, and fission product
barriers. The importance of licensed operator actions to the protection
of public health and safety is reflected in the 10 CFR Part 55
requirements that are applicable to these individuals, including
specific licensing, examination and testing, requalification, and FFD
requirements. In addition to performing actions that are necessary for
accident mitigation, operator actions, if performed incorrectly, can be
accident initiators. The effects of fatigue on decision-making, risk-
taking, communications, and other key skills were discussed in Section
IV. D. Fatigued operators have an increased potential to commit errors,
increasing the probability of component failures, system misalignments,
and incorrect execution of accident mitigation strategies. Operator
actions are highly dependent on cognitive skills (e.g., attention,
decision-making) that are susceptible to fatigue, and operators are
frequently exposed to conditions that can induce fatigue (e.g., long
work hours, shiftwork). The NRC highlighted this concern in 1982 by
issuing its Policy on Worker Fatigue. The policy specifically addressed
the need for ``controls to prevent situations where fatigue could
reduce the ability of operating personnel to keep the reactor in a safe
condition.''
Despite the NRC's Policy on Worker Fatigue and subsequent technical
specifications to limit operator work hours, an NRC staff review of
technical specification implementation from 1997-1999 found that a
significant percentage of licensed and non-licensed operators worked
more the 600 hours of overtime in a year (SECY-01-0113, Attachment 1).
This level of overtime is two to three times the level that is
permitted for operations personnel at some foreign nuclear plants and
twice the level recommended by a 1985 expert panel (NUREG/CR-4248). In
addition, the NRC staff has noted that some licensees appeared to be
abusing the authority to permit deviations from the technical
specification limits on working hours, including deviations for
operators. For example, data provided by NEI on August 29, 2000, from
J. W. Davis, NEI, to G. T. Tracy (ADAMS Accession No. ML003746495),
indicated that during 37 refueling outages
[[Page 50583]]
conducted in 1999, more than 1,800 deviations were authorized for
licensed operators and more than 1,100 deviations were authorized for
non-licensed operators. This frequency of deviations is inconsistent
with the intent of the NRC's Policy on Worker Fatigue that deviations
should be authorized only for ``very unusual circumstances.'' The
failure of some licensees to limit the work hours of operations
personnel, considered together with the risk significance of the
activities performed by operators, indicates the need for more readily
enforceable work hour limits for operators whose job duties are
important to protect public health and safety.
Further, the work hour controls in proposed Sec. 26.199 would also
apply to individuals who direct risk-significant operations onsite.
These individuals would include management on shift, such as shift
operations management or special outage managers if those individuals
provide direction to operators. Individuals to whom the work hour
controls would apply also include engineers who provide onsite
technical direction to operations, such as test directors or reactor
engineers. These individuals perform tasks that are often highly
dependent on cognitive skills (e.g., problem-solving, decision-making,
communications) and are susceptible to fatigue-induced errors, as
described in Section IV. D. Incorrect technical direction provided to
operators can significantly challenge licensed operators and increase
the possibility of errors or events, especially when the direction is
provided by an individual who supervises the operators, or an
individual who the operator reasonably expects to have specialized
technical knowledge of the system or component being operated.
Proposed Sec. 26.199(a)(2) would be added to require the control
of work hours for individuals who are maintaining, or providing onsite
direction of maintenance of systems and components that ``a risk
informed evaluation process has shown to be significant to public
health and safety.'' To implement this proposed requirement, licensees
would be required to delineate the maintenance personnel, and personnel
who are directing maintenance onsite, who would be subject to the work
hour controls, based upon the risk significance of the SSCs that they
maintain, including, at a minimum, personnel who maintain SSCs that are
determined to be significant to public health and safety. To delineate
the scope of the maintenance job duty group, licensees could use, for
example, the risk significance determination process and criteria that
they currently use to meet the requirements of Sec. 50.65(a)(4) of
this chapter for assessing and managing the risk associated with
maintenance activities. As a consequence, the work hour controls of
proposed Sec. 26.199 would typically apply to individuals who are
maintaining or directing onsite the maintenance of SSCs that are
included within the scope of an assessment required by Sec.
50.65(a)(4). Therefore, the proposed work hour controls would apply to
the individuals who most directly affect the maintenance of SSCs that
are most important to the protection of public health and safety, which
would achieve the NRC's objective to minimize the potential for
fatigue-related errors in maintaining these risk significant SSCs.
Nuclear power plant maintenance personnel perform tasks that are
often highly dependent on cognitive skills (e.g., the ability to
comprehend oral and written instructions, problem-solving,
communication) that are susceptible to fatigue, as described in Section
IV. D. These tasks may require extensive physical effort in high heat,
humidity, and noise conditions that can exacerbate fatigue. In
addition, maintenance personnel are subject to the work scheduling
conditions of round-the-clock operations and emergent work conditions
that also can exacerbate fatigue (e.g., long work hours, unscheduled
overtime, shiftwork). Compared to rested workers, fatigued maintenance
personnel would have a higher probability of (1) taking longer to
complete maintenance activities; (2) making errors that would increase
the risk of failure of the affected SSCs to perform their function(s)
or operate for their required mission time during post-maintenance
testing, thus delaying their return to unrestricted service; and (3)
making errors that could introduce latent defects that may not be
readily detected by post-maintenance testing, but that may cause
degraded reliability (i.e., degraded performance or failure of the SSCs
at a later time). Collectively, the effects of fatigue on the
performance of maintenance personnel have the potential to decrease the
availability and reliability of SSCs that are important to the
protection of public health and safety. Therefore, the proposed rule
would require these maintenance personnel to be subject to the proposed
work hour limits to ensure that fatigue does not compromise their
abilities to safely and competently perform their duties relative to
the maintenance of these SSCs.
The proposed work hour controls would also apply to those who
direct risk-significant maintenance onsite. For example, these
individuals would include maintenance supervisors who provide direction
to maintenance technicians, and engineers who provide onsite technical
direction to maintenance crews, such as during key outage maintenance
activities. These individuals perform tasks that are often highly
dependent on cognitive skills (e.g., problem-solving, decision-making,
communications) that are susceptible to fatigue, as discussed in
Section IV. D. Incorrect technical direction provided to maintenance
technicians can significantly challenge maintenance technicians and
increase the possibility of errors or events, especially when that
direction is provided by an individual who supervises them, or an
individual who the maintenance technician reasonably expects to have
specialized technical knowledge of the system or component being
maintained.
Proposed Sec. 26.199(a)(3) would be added to require work hour
controls for individuals who perform health physics or chemistry duties
that are required of the on-site Emergency Response Organization (ERO)
minimum shift complement. Although proposed Sec. 26.199(f) would
exempt licensees from applying the work hour controls during declared
emergencies, the intent of this proposed provision would be to provide
reasonable assurance that the work schedules of these individuals
during non-emergency conditions ensure that fatigue does not compromise
their abilities to safely and competently perform their duties should
an emergency occur. NUREG-1465, ``Accident Source Terms for Light-Water
Nuclear Power Plants,'' concluded that significant fission product
releases from the bulk of the fuel can occur within 30-60 minutes after
the onset of an accident. As a function of the accident and its
severity, certain areas within the plant, while predictable and benign
during normal operations, could present elevated levels of airborne/
external radiation levels (greater that 300 Rad/hour). Additionally,
industrial hazards (e.g., explosive mixtures, smoke, toxic gas, oxygen
deficiency) that may be immediately dangerous to life and health (IDLH)
could be present. In these circumstances, health physics technicians
(HPTs) support necessary plant staff actions to assess conditions,
perform search and rescue missions, and take timely mitigation actions
(e.g., local manual operations by operators). The overall success of
responding safely
[[Page 50584]]
and appropriately to emergencies and the protection of public health
and safety depends, in part, on the ability of HPTs to safely and
competently perform their emergency response duties.
Similarly, NUREG-0654, Rev. 1, ``Criteria for Preparation and
Evaluation of Radiological Emergency Response Plans and Preparedness in
Support of Nuclear Power Plants,'' identifies the need for an on-shift
chemistry/radio-chemistry emergency response capability. On-shift
chemistry technician(s) provide an important component for a successful
response at the onset of a radiological emergency. The independent and
timely actions of the chemistry technician(s) in response to a
radiological event can provide key information for assessing core
status and estimating the source term of a potential release. By
providing defense-in-depth support for operations personnel, chemistry
technicians also assist with off-site dose calculations and ancillary
radiological protection tasks, such as sampling spaces for toxic gases
or explosive mixtures. Chemistry technicians may also be needed to
conduct analyses for the detection of hydrogen and oxygen gas
concentrations in both the reactor coolant and the containment
atmosphere. These analyses support severe accident management decisions
with respect to minimizing radiological release potential. As a
consequence, ensuring that chemistry technicians are able to safely and
competently perform their emergency response duties is essential to the
overall success of responding safely and appropriately to emergencies
and to the protection of public health and safety.
Proposed Sec. 26.199(a)(4) would be added to require work hour
controls for individuals who are performing the duties of a fire
brigade member who is responsible for understanding the effects of fire
and fire suppressants on safe shutdown capability. The proposed work
hour controls would be applicable to the members of the fire brigade
who are responsible for providing the control room operators and fire
brigade leader with information that is critical to implementing a fire
mitigation strategy to maintain safe shutdown capability for the
reactor. Attachment 1 to SECY-99-140, ``Recommendation for Reactor Fire
Protection Inspections,'' dated May 20, 1999, states that ``based on
IPEEE results, fire events are important contributors to the reported
core damage frequency (CDF) for a majority of plants. The reported CDF
contribution from fire events can, in some cases, approach (or even
exceed) that from internal events.'' Fire brigade members must retain
their cognitive abilities to be able to determine the best way to
suppress a fire to prevent additional damage to safety-related
equipment; evaluate equipment affected by a fire to report to control
room operators concerning equipment availability; make decisions
concerning smoke ventilation to prevent the fire effects from affecting
other plant operations; and coordinate fire brigade activities with
control room operators.
As discussed in Section IV. D, fatigue can substantially degrade an
individual's decision-making and communication abilities, cause an
individual to take more risks, and maintain faulty diagnoses throughout
an event. The abilities to make accurate and conservative decisions,
communicate effectively, and accurately diagnose events are key to the
duties of the fire brigade members who are responsible for providing
the control room operators and fire brigade leader with information
that is critical to implementing a fire mitigation strategy that
maintains safe shutdown capability for the reactor. Degradations of
these abilities could have significant consequences on the outcome of
an event involving a fire. For instance, a fatigued individual could
incorrectly decide to vent smoke or toxic gas to an area required for
alternate shutdown, which could prevent or impair access to equipment
needed for safe shutdown of the plant. In addition, a fatigued worker
could incorrectly apply the wrong fire suppressant, which could affect
additional equipment in the plant. Further, impaired decision-making
could lead a worker to fail to properly control flooding, which could
impact other needed equipment, or to incorrectly determine whether an
area contains critical equipment and improperly apply a suppressant in
that area. Impaired communications could also lead to incomplete
disclosure of information to licensed operators in the control room,
which could adversely impact the decision-making of those operators. If
information known to the impaired fire brigade member is not properly
communicated, operators may not initiate appropriate actions to
mitigate the fire effects, or the effects of suppressant activities, on
critical equipment. As a consequence, ensuring that fire brigade
members who are responsible for understanding the effects of fire and
fire suppressants on safe shutdown capability are able to safely and
competently perform their duties is essential to the overall success of
the fire mitigation strategy and the protection of public health and
safety.
Further, the NRC periodically grants exemptions from requirements
in 10 CFR Part 50, Appendix R [Fire Protection Program for Nuclear
Power Facilities Operating Prior to January 1, 1979] based on
protection of the levels of defense in depth listed in Section II(A) of
Appendix R to Part 50, which are ``To prevent fires from starting; to
detect, rapidly control, and extinguish promptly those fires that do
occur; to provide protection for structures, systems, and components
important to safety so that a fire that is not promptly extinguished by
the fire suppression activities will not prevent the safe shutdown of
the plant.'' Granting these exemptions is often predicated on effective
manual suppression of the fire by the fire brigade. Therefore, it is
necessary to ensure that fire brigade members who are responsible for
understanding the effects of fire and fire suppressants on safe
shutdown capability remain rested and so are able to safely and
competently perform their duties in plant events involving a fire.
Proposed Sec. 26.199(a)(5) would be added to require work hour
controls for individuals who are performing the duties of an armed
security force officer, alarm station operator, response team leader,
or watchperson at a nuclear power plant. Individuals who perform these
duties are the members of licensees' security forces who are
responsible for implementing the licensees' physical security plans. In
order to ensure that these individuals are able to meet their
responsibilities for maintaining the common defense and security, it is
necessary to ensure that they are not subject to fatigue, which could
reduce their alertness and ability to perform the critical job duties
of identifying and promptly responding to plant security threats.
Security personnel are the only individuals at nuclear power plants who
are entrusted with the authority to apply deadly force. Decisions
regarding the use of deadly force are not amenable to many of the work
controls (e.g., peer checks, independent verification, post-maintenance
testing) that are implemented for other personnel actions at a nuclear
plant to ensure correct and reliable performance. By contrast to most
other nuclear power plant job duty groups, security personnel are
typically deployed in a configuration such that some have very
infrequent contact with other members of the security force, or other
plant personnel. A lack of social contact can exacerbate the effects of
fatigue on individuals' abilities to remain alert (Horne, 1988). In
addition, these deployment positions can be fixed posts where very
little physical activity is
[[Page 50585]]
required, further promoting an atmosphere in which fatigue could
transition into sleep. Many security duties are largely dependent on
maintaining vigilance, whereas vigilance tasks are among the most
susceptible to degradation from fatigue (Rosekind, 1997; Monk and
Carrier, 2003). Finally, unlike operators, security forces lack
automated backup systems that can prevent or mitigate the consequences
of an error caused by fatigue. For these reasons, and in light of the
excessive hours that some security force personnel were required to
work following the elevated threat condition(s) in effect since the
terrorist attacks of September 11, 2001, the Commission issued Orders
for Compensatory Measures Related to Fitness-for-Duty Enhancements
Applicable to Nuclear Facility Security Force Personnel on April 23,
2003. The security force personnel who are subject to work hour
controls in the Orders would be the same individuals who would be
subject to the proposed work hour controls in this section.
Proposed Sec. 26.199(b) [Calculating work hours] would be added to
specify the time periods that licensees would include when calculating
the work hours of the individuals listed in proposed Sec. 26.199(a)
for the purposes of this subpart. The NRC's Policy on Worker Fatigue
established guidelines for the control of work hours but did not define
the concept of ``work hours'' or establish criteria for calculating
them. As a consequence, licensees have inconsistently defined and
calculated work hours when implementing the Policy through their
technical specifications and administrative procedures. This
inconsistency has contributed to some licensees permitting individuals
to work excessive hours that caused them to become fatigued. Therefore,
the proposed rule would define work hours and requirements for
calculating them to ensure consistent implementation of the work hour
controls established in this proposed section.
Proposed Sec. 26.199(b)(1) [Individual work hours] would be added
to specify those portions of a shift that a licensee must include in
work hour calculations. The proposed rule would define ``work hours''
as the amount of time that an individual performs any duties for a
licensee who is subject to this section, including all within-shift
break times and rest periods during which there are no reasonable
opportunities or accommodations appropriate for restorative sleep, but
excluding shift turnover.
The proposed rule specifically would not limit the definition of
work hours to hours that are assigned to an individual by the licensee,
that are worked on site, or that are worked as part of a scheduled
shift, but rather would require licensees to include hours during which
an individual performs any duties for the licensee. The proposed rule
defines work hours in this broad manner because the NRC is aware that
some licensees permit individuals to perform duties on behalf of the
licensee from off-site locations and during periods when the individual
is not assigned to a shift or scheduled by the licensee to be working
on site. For example, because of the large amount of administrative
work that is frequently assigned to individuals in the shift manager
role, some shift managers stay at work to review and act upon
administrative matters after the end of their scheduled shifts in order
to complete the reviews and meet deadlines. Anecdotal reports from
these individuals have indicated that they may work for 3-4 hours after
going off shift to manage their workload, with the result that the
hours they have available for personal obligations and, often, sleep
are reduced. If the proposed rule limited the calculation of work hours
to only those hours that an individual is paid by the licensee, works
on shift, and/or is scheduled to be working by the licensee, many
individuals may continue to be permitted to work excessive hours and
thereby become fatigued. Therefore, proposed Sec. 26.199(b)(1) would
require licensees to include these work hours in their work hour
calculations.
The proposed rule would not require licensees to include the time
periods during which an individual participates in shift turnover in
the calculation of the individual's work hours. Proposed Sec.
26.199(b)(1)(i) would be added to define the specific shift turnover
activities that licensees may exclude from their work hour
calculations. The proposed rule would define shift turnover as only
those activities that are necessary to safely transfer information and
responsibilities between two or more individuals between shifts. Shift
turnover is a vital activity, but it also contributes to the length of
the work day, and therefore, to worker fatigue. The NRC understands
that shift turnovers routinely add approximately 30 minutes to the
length of a shift and typically no more than 2-2.5 hours to the length
of a typical work week. Stakeholder comments during the public meetings
described in Section V highlighted the importance of this activity for
communicating plant status information between work crews as well as
concern that including turnover time in work hour calculations could
cause indirect pressure on individuals to abbreviate shift turnovers in
order to ensure that work hour limits would not be violated. This
pressure could compromise the quality of shift turnovers and have
unintended adverse safety consequences, such as omitting important
equipment or maintenance status information. Although some stakeholders
believe that turnover is part of the workday and, therefore, should be
included in the calculation of hours worked, the NRC believes that the
benefit of including turnover for managing worker fatigue would be
outweighed by the potential adverse consequence on the quality of shift
turnovers.
The proposed exclusion of shift turnover from the work hour
calculations would be consistent with the current requirements in most
licensee technical specifications for the control of work hours for
personnel performing safety-related functions, and with GL 82-12. For
example, most technical specifications state, ``An individual should
not be permitted to work more than 16 hours in any 24-hour period, nor
more than 24 hours in any 48-hour period, nor more than 72 hours in any
7-day period, all excluding shift turnover time;'' (see SECY-01-0113,
Fatigue of Workers at Nuclear Power Plants, Attachment 1, Table 2).
However, the proposed rule would more clearly describe the activities
may be included in turnover and the activities that may not be
included. The proposed provision would address NRC concerns arising
from observations that licensees have occasionally excluded 2 or more
hours from calculated work hours on the basis that the individuals were
engaged in ``turnover.'' In order to ensure that turnover is not
hurried, the proposed rule would not establish a time limit for an
acceptable turnover period. However, by clearly delineating the
activities that licensees may consider to be turnover activities, the
proposed rule would reduce the potential for individuals and/or
licensees to use the proposed shift turnover exclusion to perform other
work activities.
Proposed Sec. 26.199(b)(1)(ii) would be added to permit licensees
to exclude within-shift breaks and rest periods from their work hour
calculations only if the individual has both a reasonable opportunity
and accommodations for restorative sleep. The proposed rule would
permit licensees to exclude breaks from the accounting of work hours
only when the exclusion can be
[[Page 50586]]
justified on the basis that the break substantively mitigates fatigue.
The proposed exclusion would be added to address circumstances in which
workers may be scheduled for round-the-clock duties (e.g., dedicated
fire brigades) during which they are on site and available to respond
as needed, but the licensee provides sleeping accommodations and the
individuals are allowed periods of time to obtain restorative sleep.
This proposed exclusion would also permit licensees to make use of
strategic napping, a well-proven fatigue countermeasure (McCallum, et
al., 2003; Petrie, et al., 2004; Rosekind, et al., 1994, 1995; Dinges,
et al., 1988; Kemper, 2001; Schweitzer, et al., 1992; Sallinen, et al.,
1998), without requiring the nap period to be included in work hour
calculations.
The proposed exclusion would be limited to that portion of a break
or rest period in which there is reasonable opportunity for restorative
sleep. For example, a 15-minute coffee break would not provide a
reasonable opportunity for restorative sleep. The proposed requirement
would be worded to limit the exclusion to the amount of the time the
individual has available to actually sleep, and would not include
transit time to and from the sleep accommodations. The term,
``restorative sleep,'' means an amount of sleep that mitigates fatigue,
which is generally considered to be a minimum of approximately 30
minutes (Buxton, et al., 2002; McCallum, et al., 2003; Sallinen, 1998;
Rosekind, 1995).
The proposed provision would also require that individuals must
have available reasonable accommodations for sleep in order to exclude
the break period from the calculation of the individual's work hours.
Reasonable accommodations would include a sleep surface in a darkened,
quiet room (e.g., bed, recliner) (Priest, 2000).
This degree of specificity in the proposed paragraph would be
necessary because presently some licensees exclude within-shift breaks
from the calculation of work hours required by their technical
specifications. Excluding break periods from the calculation of work
hours can add up to as many as 12 hours over the course of a week,
which permits individuals to work an additional 12-hour shift. As a
consequence, licensees may assign seven consecutive 12-hour shifts to
individuals, but only include 72 hours in their work hour calculations,
rather than the 84 hours that the individuals are actually at work.
This practice permits individuals to work continuous 12-hour shifts
without the licensee having to authorize a deviation from technical
specification requirements. The discussion of proposed Sec.
26.199(d)(1)(iii) details the basis for limiting individuals to 72 work
hours per week.
Although breaks without sleep have some fatigue mitigation value
(Tucker, Folkard and Macdonald, 2003), the benefits are principally
limited to short-term improvements in vigilance. Horne (1988), Mitler
and Miller (1996), and Dinges, et al. (1997) have pointed out that the
only non-pharmacological cure for fatigue is sleep. The duration of
within-shift break times is normally insufficient to allow a worker to
obtain sleep and, consequently, these periods add to the total amount
of time an individual remains awake while at work. Time since awakening
is a principal determinant of worker fatigue (Folkard and Akerstedt,
1992; NTSB, 1994; Akerstedt, 2004) and performance generally declines
as a function of the amount of time that an individual remains awake
(Dawson and Reid, 1997). Because within-shift breaks and rest periods
provide only short-term mitigation of fatigue (Kruger, 2002; Baker, et
al., 1990), the proposed rule would require licensees to include short
breaks in the calculation of work hours.
Proposed Sec. 26.199(b)(1)(iii) would be added to permit licensees
to assign individuals, who are qualified to perform the duties listed
in proposed Sec. 26.199(a), to other duties than those listed in
proposed Sec. 26.199(a), without controlling their work hours in
accordance with the work hour controls contained in proposed Sec.
26.199(d). However, if these individuals would be assigned or returned
to performing any duties that are listed in proposed Sec. 26.199(a)
during the averaging period, the proposed paragraph would require the
licensee to include all of the hours that they worked when calculating
the individuals' work hours for the averaging period and to subject the
individuals to the work hour controls in proposed Sec. 26.199(d). For
example, if a licensed operator was assigned to training for an entire
averaging period, then his or her work hours would not be subject to
proposed Sec. 26.199(d) for that period because he or she would not be
performing any of the duties listed in proposed Sec. 26.199(a)(1).
However, if the same individual was assigned to training for only a
portion of the averaging period and performed the duties listed in
proposed Sec. 26.199(a)(1) during the remainder of the averaging
period, all of his or her hours, including those worked while assigned
to training, would be included in the calculation of the individual's
work hours for the period and would be included in the operations job
duty group collective work hours average, as if the individual was
performing operations duties for the entire averaging period. Licensees
would be required to count the hours that the individual worked
performing other duties if an individual begins performing the duties
listed in proposed Sec. 26.199(a) during the averaging period because
the individual's level of fatigue is largely dependent on the total
number of hours he or she has worked, regardless of where the work was
performed or the nature of the work itself. Therefore, including the
hours worked performing other duties would provide assurance that
fatigue would not compromise that individual's ability to safely and
competently perform the duties that are specified in proposed Sec.
26.199(a).
Proposed Sec. 26.199(b)(2) [Collective work hours] would be added
to establish requirements for calculating the collective work hours of
the job duty groups that would be subject to the collective work hour
limits in proposed Sec. 26.199(f) [Collective work hour limits]. (The
collective work hour limits and the bases for establishing them are
discussed with respect to proposed Sec. 26.199(f).) Specifically, the
proposed rule would require licensees to calculate, at a minimum, a
separate work hour average for each job duty group in proposed Sec.
26.199(a). (Appropriate methods for defining job duty groups to which
the collective work hour limits would be applied are discussed with
respect to proposed Sec. 26.199(b)(3).)
Proposed Sec. 26.199(b)(2) would limit the length of any averaging
period that licensees may use for calculating collective work hours to
no more than 13 weeks. In proposing to limit the averaging period to no
more than 13 weeks, the NRC considered the need to account for periods
of elevated work hours, which have the potential to cause fatigue, as
well as the need for an averaging period that would not be unduly
influenced by short-term variations in work hours. The NRC also
considered industry comments during the stakeholder meetings discussed
in Section V expressing a desire for an averaging period that is
consistent with other surveillance or assessment requirements. The
proposed requirement would provide the flexibility for licensees to use
a 13-week averaging period that may be aligned with quarterly reviews
or shorter periods that coincide with existing time-keeping practices
(e.g., a multiple of pay periods). The proposed flexibility to use
shorter averaging periods would also
[[Page 50587]]
accommodate other circumstances, such as an outage period that occurs
within a 13-week averaging period, during which the proposed rule would
not require licensees to implement the collective work hour controls,
as permitted in proposed Sec. 26.199(f)(2)(iii). Licensees may choose
to define shorter averaging periods in these circumstances in order to
synchronize subsequent averaging periods with their other scheduling
demands (e.g., quarterly reviews, pay periods, the calendar or fiscal
year).
The NRC considered both shorter and longer periods in determining
the proposed maximum duration for an averaging period. The NRC rejected
requiring a shorter maximum averaging period because it would increase
the potential for short-term (e.g., 2-3 weeks) emergent work conditions
to cause group averages to exceed the 48-hour collective work hours
limit in proposed Sec. 26.199(f), if overtime is required to respond
to the emergent work. These short-term work periods of high overtime
use have limited potential for causing cumulative fatigue, considering
the individual work hour controls in proposed Sec. 26.199(d).
Therefore, group averages that are based on shorter averaging periods
may overestimate the cumulative fatigue of a job duty group. By
contrast, increasing the averaging period to more than 13 weeks would
permit a job duty group to work for more than three weeks at the
individual limit of 72 hours in 7 days in proposed Sec.
26.199(d)(1)(iii) without raising the group average above the 48-hour
limit. Therefore, repeated periods of elevated group work hours would
not be reflected in the job duty group average and may cause a licensee
to delay taking any short-term or long-term corrective actions that may
be necessary to control cumulative fatigue within a job duty group.
Therefore, the NRC determined that the 13-week averaging period would
provide the appropriate level of sensitivity for licensees to identify
and respond to conditions that present a significant potential for
cumulative fatigue.
Proposed Sec. 26.199(b)(2)(i) would be added to permit licensees
to calculate collective work hours for each of the broad job duty
groups that is listed in proposed Sec. 26.199(a) or smaller sub-groups
that would be comprised of individuals who are performing similar
duties within any of these broad job duty groups. However, the proposed
rule would also require that licensees who elect to calculate
collective work hours for smaller sub-groups must ensure that the work
hours of all individuals in the broader job duty groups listed in
proposed Sec. 26.199(a) are included in the collective work hour
calculations of a smaller job duty group. That is, the proposed rule
would require licensees to ensure that the work hours of all
individuals who perform job duties that require them to be subject to
the proposed work hour controls of this section are counted. The
proposed rule would not permit licensees to combine the broad job duty
groups into a larger group (e.g., combining the operations and
maintenance groups) because doing so may mask excessive work hours in
one of the job duty groups. Separate calculations for each job duty
group would be necessary to ensure that the work hours of each job duty
group as a whole would be maintained at a level that is consistent with
the proper management of cumulative fatigue.
In establishing the requirements for calculating collective
averages in proposed Sec. 26.199(b)(2)(i) (i.e., determining how many
job functions may be included in a collective average), the NRC weighed
the merits of limiting the job duty groups to narrow collections of
similarly qualified individuals who are capable of performing each
other's duties, and therefore sharing workload and work hours.
Requiring licensees to calculate collective work hours for smaller sub-
groups would provide a more precise indication of work hours. Defining
smaller sub-groups would also provide greater assurance of identifying
groups of individuals who may be working excessive hours because of
inadequate staffing for specific job skills.
However, the proposed rule would not require licensees to calculate
collective work hours for smaller sub-groups for several practical
reasons:
(1) It would be difficult to define such groups in the rule in a
manner that licensees could interpret and implement consistently,
considering the diversity of their organizational structures and
nomenclature for job duties;
(2) Individuals within the broad job duty groups may be qualified
to perform functions in multiple sub-groups. Therefore, assigning these
individuals to an appropriate sub-group would be challenging and likely
to result in inconsistent implementation of the proposed rule; and
(3) Individuals would be likely to transition between sub-groups
within an averaging period due to changes in their work focus or
qualifications, which would impose a significant burden on licensees to
track each individual's sub-group membership.
For these reasons, the proposed rule would not require licensees to
define narrower sub-groups, although it would permit licensees to
define such sub-groups for calculating collective work hours.
The proposed requirements for defining groups for calculating
collective work hours would ensure that, at a minimum, collective work
hour calculations would provide an indication of a licensee's control
of work hours for broad licensee functions (e.g., operations,
maintenance, security) that are important to the protection of public
health and safety and the common defense and security. Further,
proposed Sec. 26.199(j)(2) and (4) would require licensees to identify
and take corrective action for instances of excessive work hours
indicating inadequate staffing for any job that would be subject to the
work hour controls of proposed Sec. 26.199(f). Therefore, collective
work hour calculations for broad job duty groups would appropriately
support the objectives of the collective work hour controls, when
implemented in conjunction with the requirements of proposed Sec.
26.199(j)(2) and (4), and provide assurance that the work hours of each
job duty group as a whole would be maintained at a level that is
consistent with the proper management of cumulative fatigue.
Proposed Sec. 26.199(b)(2)(ii) would be added to require licensees
to include, in the calculation of collective work hours for each job
duty group, the work hours of any individual who performs the job
duties of the job duty group, as determined by the licensee in
accordance with proposed Sec. 26.199(b)(2)(i). The NRC intends the
term, ``any individual who performs,'' as used in proposed Sec.
26.199(b)(2)(ii), to mean individuals who are qualified to perform the
specified duties.
The NRC considered limiting the calculation of collective work
hours to individuals who actually performed the duties of the job duty
group during the averaging period. However, during the stakeholder
meetings discussed in Section V, industry representatives indicated
that this alternative would result in a substantial administrative
burden associated with tracking whether each individual actually
performed any duties of the group during the averaging period. The NRC
considered this comment, as well as the increased volatility of group
size and membership that would result from the alternative approach,
and concluded that the administrative simplification of defining group
membership based on qualifications would substantially reduce the
burden of the proposed requirement without a commensurate reduction in
the effectiveness of the
[[Page 50588]]
collective work hour controls in addressing cumulative fatigue. The
proposed approach that is based on qualifications would require
licensees to expend significantly fewer resources than tracking which
individuals are performing specific tasks on a constantly changing
basis. The effectiveness of the work hour controls would not be reduced
because the number of individuals who are qualified to perform most of
these job duties is not substantially greater than the size of each job
duty group. Therefore, the effect of including the work hours of a few
individuals who are qualified to perform the groups' job duties but did
not actually perform any of those duties during an averaging period
would be minimal.
Proposed Sec. 26.199(b)(2)(ii) would also require the licensee to
include in the calculations the work hours of ``any individual'' who
performs the specified job duties, regardless of the individual's
employer. The NRC recognizes that many of the job functions in the job
duty groups listed in proposed Sec. 26.199(a) are performed by C/Vs,
as well as by direct employees of the licensee. It is important to
provide reasonable assurance that fatigue does not impair the job
performance of any individual who performs these duties, irrespective
of the individual's organizational affiliation. Therefore, the proposed
rule would require licensees to include in the collective work hours
calculations for the appropriate job duty group any work hours of C/V
personnel who perform the specified job duties.
Proposed Sec. 26.199(b)(2)(ii) would require licensees to include
in their calculations only the hours that individuals worked ``at the
licensee's site'' during the averaging period, but not any hours that
the individuals may have worked at other facilities. Therefore,
collective work hour calculations would not include any work hours that
an individual may have worked during the averaging period, for example,
at another nuclear plant, at a non-nuclear power plant, or in any other
place or form of employment. The NRC acknowledges that hours worked,
irrespective of whether the work is performed at a nuclear power plant
or any other place of employment, can contribute to worker fatigue, and
that consideration of all hours worked would provide a more complete
basis for assessing the potential for worker fatigue. However, in
establishing the requirement to include only hours worked at the
licensee's site in the collective work hours calculations, the NRC also
considered the practical constraints on the ability of licensees to
obtain complete and reliable work hours information from other
employers. In addition, the NRC anticipates that licensees would comply
with the collective work hour controls of proposed Sec. 26.199(f)
[Collective work hour limits] by continuing to distribute work hours
and rest days among individuals in accordance with the capabilities and
needs of the individuals, consistent with most licensees' current
practices. Accordingly, the proposed work hour requirements would apply
only to those work hours which the licensee can directly control and
manage, which are the hours that an individual works for the licensee.
A second implication of adding the phrase, ``at the licensee's
site,'' to the proposed paragraph is that the proposed rule would
prohibit licensees from combining all of the individuals across a fleet
of plants who may be subject to the same FFD program into one of the
broad job duty groups listed in proposed Sec. 26.199(a). For example,
if one licensee operates units at four different sites, proposed Sec.
26.199(b)(2)(ii) would permit the licensee to create an operations job
duty group for multiple units at one site, but would prohibit the
licensee from combining the work hours of all operations personnel
across the four different sites to calculate a fleet-wide group
average. The proposed prohibition would be necessary to ensure that the
size of the job duty groups is not so large that excessive work hours
in a job duty group at one site would be masked by lower work hours in
the same job duty group at another site, with the result that the group
average would be insensitive to local variations in work hours.
Proposed Sec. 26.199(b)(2)(ii) would also require licensees to
include in their collective work hours calculations only the work hours
of individuals who worked at least 75 percent of the normally scheduled
hours of the job duty group. This proposed limitation would ensure that
job duty group averages are not artificially suppressed by including
the work hours of individuals who worked part-time or substantially
less than full-time during the averaging period. For example, the
proposed rule would prohibit licensees from including in their
calculations the work hours of individuals who were on disability or
maternity leave for more than 25 percent of the averaging period, or
entered or left the job duty group as a result of a personnel action,
without working 75 percent of the group's normally scheduled hours. The
proposed limitation would be necessary to ensure that the collective
average would actually represent the work hours of the individuals who
comprised the job duty group for the majority of the averaging period.
Proposed Sec. 26.199(b)(2)(iii) would be added to require that the
licensee-defined averaging periods must comprise consecutive days or
days that are separated only by days that licensees would be permitted
to exclude from the collective work hour calculations in proposed Sec.
26.199(f)(1)-(f)(3) and (f)(5), (h), and (i). That is, the proposed
rule would require that the averaging period must comprise consecutive
days unless outages, increased threat conditions, plant emergencies,
and the other conditions that are specified in proposed Sec.
26.199(f)(1)-(f)(3) and (f)(5), (h), and (i) occur during the averaging
period. This proposed requirement would be necessary to prevent
licensees from selectively constituting averaging periods to meet the
collective work hour limits by combining work hours during disparate
time periods.
However, if any of the conditions arise that are specified in
proposed Sec. 26.199(f)(1)-(f)(3) and (f)(5), (h), and (i) (e.g.,
outages, increased threat conditions, plant emergencies) during an
averaging period, the proposed paragraph would permit licensees to
combine consecutive days immediately preceding and following the
excluded period(s) to constitute a complete averaging period. For
example, if the length of a licensee's averaging period is 13 weeks and
two weeks of an averaging period had elapsed before an increased threat
condition occurred (or an outage period began), the licensee could
define an averaging period as including those two weeks and the 11
weeks that followed the end of the increased threat condition.
The objective of proposed Sec. 26.199(b)(2)(iii) would be to
ensure that collective work hour calculations are representative of
typical work hours during a distinct period, to the extent practicable,
while recognizing that there may be intervening periods that would be
excluded from the collective work hour controls that would disrupt the
licensee's normal averaging period schedule. The proposed rule would
permit licensees flexibility in comprising their averaging periods in
these instances in order to minimize a potential administrative burden
that could result from averaging periods that, because of the exclusion
period, are no longer synchronized with other needs (e.g., pay periods,
the fiscal year). Because the exclusion periods would occur
infrequently, the NRC anticipates that permitting licensees flexibility
in constituting averaging periods around
[[Page 50589]]
an excluded period would not mask any systemic or programmatic
weaknesses in the licensees' work hour controls over the long-term.
Proposed Sec. 26.199(b)(2)(iv) would be added to require licensees
to include in an averaging period all days that are not excluded from
the collective work hour controls under proposed Sec. 26.199(f))(1)-
(f)(3) and (f)(5), (h), and (i). Proposed Sec. 26.199(b)(2) would
provide licensees substantial flexibility in comprising averaging
periods that include, or are contiguous with, periods that would be
excluded from the collective work hour controls. However, the proposed
rule would add this proposed provision to ensure that licensees'
collective work hour calculations are complete and represent the
typical work hours of individuals by requiring that all days not
specifically excluded from collective work hour requirements would be
included in at least one averaging period.
Proposed Sec. 26.199(b)(2)(v) would be added to prohibit licensees
from including any individual's work hours in more than one averaging
period. The proposed rule would prohibit double-counting of work hours
to ensure that each collective work hours average would represent the
work hours of each job duty group during a discrete period of time.
Proposed Sec. 26.199(c) [Work hours scheduling] would be added to
require licensees to schedule the work hours of individuals who are
subject to this proposed section in a manner that is consistent with
the objective of preventing impairment from fatigue due to the
duration, frequency, or sequencing of successive shifts. The maximum
work hour and minimum break requirements that are specified in proposed
Sec. 26.199(d) [Work hour controls for individuals] would be intended
for infrequent, temporary circumstances, and not as guidelines or
limits for routine work scheduling. In addition, the work hour controls
in proposed Sec. 26.199(d) would not address several elements of
routine schedules that can significantly affect worker fatigue, such as
shift length, the number of consecutive shifts, the duration of breaks
between blocks of shifts, and the direction of shift rotation.
Therefore, proposed Sec. 26.199(c) would require licensees to schedule
personnel consistent with preventing impairment from fatigue from these
scheduling factors.
The proposed rule would require licensees to address scheduling
factors because human alertness and the propensity to sleep vary
markedly through the course of a 24-hour period. These variations are
referred to as circadian rhythms and are the result of changes in
physiology brought about by a circadian clock or oscillator inside the
human brain that is outside the control of the individual. Work may be
scheduled, and the consequent timing of periods of sleep and
wakefulness, in a manner that either facilitates an individual's
adaptation to the work schedule or challenges the individual's ability
to get adequate rest. Therefore, the duration, frequency, and
sequencing of shifts, particularly for personnel who work rotating
shifts, are critical elements of fatigue management. The effect of
circadian rhythms on worker fatigue is also discussed in Section IV. D.
The importance of these elements for fatigue management is reflected in
guidelines for work scheduling, such as NUREG/CR-4248 and EPRI NP-6748
(Baker, et al., 1990), and in technical reports, such as the Office of
Technology Assessment's report, Biological Rhythms: Implications for
the Worker (Liskowsky, 1991). The EPRI report, for example, addresses
issues related to the sequencing of day, evening, and night shifts, and
the use of break periods between shifts to optimize the ability of
personnel to obtain adequate sleep and effectively transition from one
shift to another. Although research provides clear evidence of the
importance of these factors in developing schedules that support
effective fatigue management, the NRC also recognizes that the
complexity of effectively addressing and integrating each of these
factors in work scheduling decisions precludes a prescriptive
requirement. Therefore, proposed Sec. 26.199(c) would establish a non-
prescriptive, performance-based requirement.
Proposed Sec. 26.199(d) [Work hour controls for individuals] would
be added to specify that licensees must establish work hour controls
for each individual who performs the duties listed in proposed Sec.
26.199(a). The proposed rule would require licensees to establish
controls that would limit work periods and provide for breaks that are
of sufficient length to allow the individual to obtain restorative
rest.
Proposed Sec. 26.199(d)(1) would be added to establish work hour
limits for consecutive, rolling periods of 24 and 48 hours and seven
days. The majority of licensees have incorporated the work hour
controls from the NRC's Policy on Worker Fatigue, as disseminated by GL
82-12, into either their technical specifications or administrative
procedures. The Policy (including the bases for the individual
requirements) has been in place for over 20 years and was the subject
of a substantive review that is documented in Attachment 1 to SECY-01-
0113. The work hour limits from GL 82-12 also were the subject of
substantial stakeholder comment during the public meetings described in
Section V. In developing the proposed requirements in this paragraph,
the NRC staff considered the information gained through these
stakeholder interactions.
Proposed Sec. 26.199(d)(1)(i) would limit the number of hours that
an individual may work in any 24-hour period. The proposed paragraph
would permit individuals to work no more than 16 work hours in any 24-
hour period. This proposed limit would be identical to that specified
in GL 82-12. Attachment 1 to SECY-01-0113 provides the basis for this
proposed limit, which is summarized as follows: Studies have shown that
task performance declines after 12 hours on a task (Folkard, 1997;
Dawson and Reid, 1997; Rosa, 1991). Other studies have shown that the
relative risk of having an accident increases dramatically after 9
consecutive hours on the job (Hanecke, et al.,1998; Colquhoun, et
al.,1996; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2,
2000, 65 FR 25544). Further, a maximum of 12 work hours per day was the
limit recommended by nine experts who met in 1984 to develop
recommendations for NUREG/CR-4248. Therefore, in originally developing
the NRC's Policy on Worker Fatigue, the NRC had planned a 12-hour
maximum limit, but revised it to 16 hours in response to practical
concerns from industry that the 12-hour limit required personnel who
worked 8-hour shifts to split shifts when they work overtime. Those
practical concerns remain valid, and the proposed rule would retain a
16-hour limit.
Although the proposed rule would permit 16-hour shifts, other work
hour limits in the proposed rule would effectively limit the number of
16-hour shifts that licensees could assign. This issue is discussed in
greater detail in Section V, with respect to a comment on proposed
Subpart I by PROS.
Proposed Sec. 26.199(d)(1)(ii) would limit the number of hours
that an individual may work in any 48-hour period. The proposed
paragraph would permit an individual to work no more than 26 work hours
in a 48-hour period, by contrast to the related limit in GL 82-12,
which limits individuals' work hours to 24 work hours in any 48-hour
period. This proposed change would be made to accommodate the fact that
most licensee sites are now working routine 12-hour shifts, rather than
routine 8-hour shifts, as was the case when GL 82-12 was published. At
that time, the
[[Page 50590]]
basis for the 24-hour limit was to permit a worker to work one 16-hour
double shift, followed by an 8-hour break, and then start another 8-
hour shift at the worker's normal starting time, but only in very
unusual circumstances. With most plants now routinely working 12-hour
shifts, the proposed rule would increase the maximum work hours in a
48-hour period from 24 to 26 hours to decrease the burden on licensees
that would be imposed by accommodating situations in which a worker's
relief is delayed, or similar circumstances. For example, a 12-hour
shift worker could work up to 14 hours in one day and still return to
work at his or her normal time the next day, but could only work 12
hours that day. In the extreme, the proposed 26-hour limit would permit
an individual to work up to 16 hours one day, followed by a minimum 10-
hour break, as required in proposed Sec. 26.199(d)(2)(i). The
individual would then be limited by the proposed requirement to 10
hours of work over the next 22 hours.
In developing the proposed relaxation of the previous 24-hour limit
on the number of hours that individuals can work in 48 hours, the NRC
considered several factors. These factors include:
(1) The burden associated with granting a waiver for the additional
two hours;
(2) The increased stringency of the criteria for granting a waiver
of the work hour limits in proposed Sec. 26.199(d)(3) relative to
those in plant technical specifications; and
(3) The increased potential for worker fatigue and fatigue-related
errors that may accrue from working 26 hours in a 48-hour period versus
working 24 hours in that same period.
The increase of two additional work hours during a 48-hour period
would likely contribute to some increase in fatigue and fatigue-related
errors, particularly when these hours come at the end of a work period
of 12 or more hours or coincide with a decrease in an individual's
circadian level of alertness, as might be expected at the end of a 12-
hour day shift. However, because the revised criteria for granting a
waiver of the work hour limits in proposed Sec. 26.199(d)(3) are
expected to substantially reduce the number of waivers that would be
granted, the licensee would have to either delay or turn over any work
that the individual is performing when it is necessary for him or her
to go off-shift. Either delaying or turning over work could contribute
to errors. In addition, licensee use of waivers to exceed the 24-hours
of work in any 48-hour period limit for short durations is common
practice. As a result, the NRC believes that the proposed relaxation
would principally reduce the paperwork burden, rather than result in an
increase in the hours that individuals would actually work under the
proposed rule. Accordingly, the proposed relaxation would provide a
substantive reduction in burden with a limited net effect on human
performance reliability.
Proposed Sec. 26.199(d)(1)(iii) would be added to limit the number
of hours an individual may work in any 7-day period. The proposed
paragraph would limit an individual to working no more than 72 hours in
any 7-day period. This proposed limit would be identical to the related
limit specified in GL 82-12. Attachment 1 to SECY-01-0113 provides the
basis for the proposed limit, which is summarized in this paragraph: In
the absence of the break requirements in proposed Sec. 26.199(d)(2),
the proposed limit could potentially permit a worker to work six 12-
hour shifts per week continuously. Studies have shown that longer work
schedules cause fatigue (Colquhoun, 1996; Rosa, 1995). Human
reliability analysis experts have recommended that the NRC set ``a
maximum of 60 hours in any 7-day period and a maximum of 100 hours in
any 14-day period,'' noting studies indicating that fatigue from long
work hours can result in personnel developing their own subjective
standards of what is important in their jobs (NUREG/CR-1278, ``Handbook
on Human Reliability Analysis with Emphasis on Nuclear Power Plant
Applications''). Further, NUREG/CR-4248 recommends a limit of 60 hours
of work in a 7-day period. However, in the NRC's Policy on Worker
Fatigue, the NRC established a 72-hour maximum limit based on the
expectation that individuals would work up to this limit on an
infrequent and temporary basis. The proposed rule would codify this
expectation, in part, through proposed Sec. 26.199(d)(2)(iii), which
would require licensees to schedule a 48-hour break every 14 days for
individuals who are subject to the proposed work hour controls, and
would, thereby, effectively prevent an individual from working six 12-
hour shifts for more than 1 week at a time.
Proposed Sec. 26.199(d)(2) would be added to require licensees to
provide adequate rest breaks for individuals who are performing the
duties listed in proposed Sec. 26.199(a). This proposed requirement
would be necessary to ensure that licensees provide individuals with
sufficient time off between work periods (shifts) to permit the
individuals to recuperate from fatigue and provide reasonable assurance
that acute and cumulative fatigue do not compromise the abilities of
these individuals to safely and competently perform their duties. Acute
fatigue results from excessive cognitive work, especially if an
individual is missing significant amounts of sleep, and is readily
relieved by obtaining adequate rest and sleep. Cumulative fatigue
results from receiving inadequate amounts or poor quality sleep for
successive days. An extensive body of research has shown that a lack of
adequate days off and extended workdays result in a cumulative sleep
debt and performance impairment [Williamson and Feyer, 2000; Tucker,
1999; Colquhoun, 1996; Baker, et al., 1994; Webb and Agnew,1974; U.S.
DOT (65 FR 25546; May 2, 2000)].
Proposed Sec. 26.199(d)(2) would define a rest break as an
interval of time that falls between successive work periods, during
which the individual does not perform any duties for the licensee. For
example, during rest breaks, individuals would not be performing work-
related duties such as completing paperwork reviews, mandatory reading,
or required self-study. Rest breaks could include periods during which
an individual is ``on-call'' because actual demands on an individual's
time while he or she is on-call would be infrequent and of limited
duration, such as answering a phone call. However, if an individual who
is ``on-call'' is ``called-in'' to report to the site, the licensee
would be required to include the hours that the individual worked as
work hours, rather than as break time, because the individual would be
performing duties on behalf of the licensee while on site. The proposed
rule would permit individuals to conduct shift turnovers within rest
break periods, as discussed with respect to proposed Sec.
26.199(b)(1)(i).
Proposed Sec. 26.199(d)(2)(i) would be added to require licensees
to provide a 10-hour break between successive work periods, but would
permit 8-hour breaks in limited circumstances in which a shorter break
would be necessary for a crew's scheduled transition between work
schedules. Current licensee technical specifications and administrative
procedures that are based on GL 82-12 require a minimum 8-hour break
between work periods. Proposed Sec. 26.199(d)(2)(i) would increase the
minimum break period from 8 hours to 10 hours in order to provide
greater assurance that individuals have an adequate opportunity to
obtain the 7-8 hours of sleep that are recommended by most experts in
work scheduling and fatigue. When considering shift turnover and
commute times, which do not provide individuals with opportunities
[[Page 50591]]
for rest and recovery, a nominal rest break of 8 hours actually leaves
the individual with approximately 6 hours available to meet personal
needs, including sleep (8.0 hours off-duty minus an average 1.5-hour
round-trip commute minus an average 0.5 hours spent in shift turnover,
equaling 6 hours available for personal needs). However, individuals
typically also require 0.5 hours for preparing (or buying) and eating
at least one meal off-shift, and 0.5 hours for personal hygiene, which
leaves, at best (i.e., assuming no social or domestic commitments that
day), a total of 5 hours available for sleep. By contrast, the 10-hour
break would ensure that individuals would generally have 7 hours
available each day for sleep, which is close to the 7-8 hours of sleep
needed by adults in the U.S. (National Sleep Foundation, 2001; Monk, et
al., 2000; Rosekind, et al., 1997; Rosa, 1995).
The scientific literature provides strong evidence of the negative
effects on performance and alertness of a week of sleep restriction to
5 hours. Dinges, et al., 1997, and Belenky, et al., 2003, who both
represent key laboratories in the field of sleep deprivation (the
University of Pennsylvania and the Walter Reed Army Institute of
Research, respectively), have conducted studies in this area. Belenky,
et al. (2003) clearly demonstrates that limiting sleep to 5 hours per
night leads to significant impairment in both alertness and actual
performance, which builds up over the week, compared to the alertness
and performance of individuals who obtain 7 hours of sleep per night.
The difference was found to be significant on all days during which
sleep was restricted to 5 hours. Compared to the research subjects'
performance after two baseline nights during which they obtained 7
hours of sleep, the subjects' performance after nights during which
they were restricted to 5 hours of sleep showed more than twice as many
lapses (extra slow responses). Dinges, et al. (1997) obtained similar
results. From the second baseline day (the last day during which a full
7 hours of sleep was obtained) through the seven partial sleep
restriction days, the research subjects' sleepiness and performance
became progressively worse and these effects achieved a high level of
statistical significance. The Dinges, et al. study also concluded that
``* * * recovery from these deficits appeared to require two full
nights of sleep.''
The importance of adequate sleep and the need to provide adequate
opportunity for sleep in work schedules are reflected in studies (e.g.,
Kecklund and Akerstedt, 1995; Wylie, et al., 1996), guidelines (Pratt,
2003; Baker, et al., 1990), handbooks (Tepas and Monk, 1987), and the
panel recommendations of sleep and fatigue experts (e.g., NUREG/CR-
4248). The importance of providing an opportunity for at least 8 hours
of sleep is also noted in an EPRI/NEI Work Hours Task Force white
paper, Managing Fatigue in the Nuclear Energy Industry: Challenges and
Opportunities (ADAMS Accession No. ML0221740179). The report, prepared
by Mark Rosekind, states that ``the strongest and most extensive data
demonstrate that sleep is a critical factor in promoting alertness and
performance in subsequent wakefulness. Data clearly show that acute and
cumulative sleep loss degrade subsequent alertness and performance.
Therefore, any `hours of service' policy should emphasize the provision
of an appropriate sleep opportunity prior to duty.'' More specifically,
human reliability analysis experts have recommended that the NRC
require ``a break of at least 12 hours between all work periods''
(NUREG/CR-1278). Similarly, a panel of sleep and fatigue experts
criticized a DOT requirement for an 8-hour break for motor carriers as
inadequate because 8 hours of off-duty time does not translate into 8
hours of sleep. The DOT has since amended its regulations for motor
carriers to require 10-hour rest breaks (68 FR 22456-22517; April 28,
2003).
Although a longer minimum rest break requirement would provide
greater assurance that individuals have adequate opportunities for
sleep, the proposed 10-hour break requirement would provide adequate
opportunity for rest when used infrequently, as would be expected given
other requirements in this proposed rule. For example, proposed Sec.
26.199(d)(1)(ii) would limit individuals to working 26 hours in any 48-
hour period. Although licensees could use routine 10-hour breaks in
conjunction with atypical shift durations (e.g., alternating 12- and
14-hour shifts), the practical implications of these schedules, such as
varied start times, make their use improbable. As a consequence, the
10-hour break requirement would be sufficient to assure adequate rest
during infrequent circumstances in which individuals may work extended
hours (e.g., more hours than their typical 8-, 10-, or 12-hour shift)
and that rest opportunities would typically vary between 12 and 16
hours in duration.
The proposed minimum 10-hour break duration would also accommodate
most scheduling circumstances for the common shift durations that are
currently in use in the industry. A notable exception is that the
proposed 10-hour break requirement could potentially prevent an
individual who has worked 16 hours straight (e.g., two consecutive 8-
hour shifts) from returning to duty at the start of his or her next
regularly scheduled shift. However, the 10-hour break requirement would
appropriately prevent the individual from working in this circumstance,
because the potential for degraded job performance resulting from
fatigue would be substantial, given the individual's continuous hours
of work and limited opportunity to sleep.
Proposed Sec. 26.199(d)(2)(i) would permit a minimum 8-hour break
in only one circumstance. That is, the proposed paragraph would permit
licensees to schedule an 8-hour break, if the 8-hour break is necessary
to accommodate a crew's scheduled transition between work schedules.
During the public meetings described in Section V, the NRC received
comments that the proposed 10-hour break would occasionally interfere
with a transition from 12-hour shifts to 8-hour shifts. This transition
would typically occur at the end of an outage for individuals who
normally work an 8-hour shift, but work a 12-hour shift during outages.
Although the proposed exception would provide individuals with less
time for recovery, the shorter break would be limited to one break
occurring on a very restricted frequency. Therefore, the proposed
permission for an 8-hour break in the circumstances of a shift
transition would provide scheduling flexibility with minimal potential
to adversely affect an individual's ability to safely and competently
perform his or her duties.
Proposed Sec. 26.199(d)(2)(ii) would be added to require a 24-hour
break in any rolling 7-day period. Break periods longer than 10 hours
between shifts are necessary on a regular basis in order to maintain
reliable human performance. For example, Belenky, et al. (2003) found
that the performance of subjects whose sleep periods were restricted to
7 hours per night over 7 consecutive days increasingly degraded as the
number of sleep-restricted days increased. Van Dongen, et al. (2003)
similarly found that the performance of subjects whose sleep was
limited to 8-hours per night also declined over a two-week period. The
only subjects in these studies who did not show any performance
decrements were those who were permitted 9-hour sleep periods in the
Van Dongen study. These results clearly demonstrate that individuals
require more rest than a 10-hour break provides over time to prevent
performance degradation from cumulative fatigue, including that
[[Page 50592]]
which accrues from a series of days of mild sleep restriction (e.g., 7
hours per night).
Further, a 10-hour break provides an opportunity for 7 hours of
sleep only if one assumes the minimal times for meals, hygiene, and
commuting described with respect to proposed Sec. 26.199(d)(i), with
no other daily living obligations. These assumptions are realistic only
for unusual circumstances and limited periods of time during which
individuals may be able to temporarily defer their other obligations.
As the number of consecutive days increases on which individuals have
only a 10-hour break available to meet these other obligations, the
pressure on individuals to restrict sleep time in order to meet these
other obligations increases. In addition, after a series of moderately
restricted sleep periods (i.e., 6 hours per night), individuals'
subjective feelings of sleepiness stabilize and they report feeling
only mild sleepiness (Van Dongen, et al., 2003), which may further
encourage individuals to restrict their sleep periods in order to meet
daily living obligations. Van Dongen, et al. noted ``* * * the lack of
reports of intense feelings of sleepiness during chronic sleep
restriction may explain why sleep restriction is widely practiced--
people have the subjective impression they have adapted to it because
they do not feel particularly sleepy.'' However, results of the Van
Dongen study also demonstrated that the performance of subjects in that
study continued to degrade as the number of consecutive restricted
sleep periods increased over a two-week period, including the
performance of subjects who were permitted 6- and 8-hour sleep periods.
Therefore, the proposed provision for a 24-hour break in any
rolling 7-day period would serve both to prevent and mitigate
cumulative fatigue. The proposed 24-hour break periods would not only
provide some opportunity for recovery sleep, but also time that
individuals need to meet the many daily living obligations that they
cannot otherwise readily meet. Without such long break opportunities,
individuals must either forego activities that can be important to
general mental and physical fitness (e.g., family interactions,
exercise, recreation, doctor appointments) or sacrifice sleep and
increase their sleep debt (Presser, 2000), resulting in impairment on
the job.
Significant considerations in the NRC's development of proposed
Sec. 26.199(d)(2)(ii) and (d)(2)(iii) were industry work scheduling
practices during outages and the applicability of other proposed
requirements during these periods. In SECY-01-0113 and NRC staff
reviews of records of deviations from technical specification work hour
controls from 2003 and 2004, the most common deviation identified was
to permit individuals to work more than 72 hours in 7 days, frequently
by working more than six consecutive 12-hour days. These reviews also
indicated that this practice was used extensively at a number of sites.
Industry comments at the public meetings described in Section V also
confirmed the NRC observation that some licensees were scheduling
outages with several weeks of 12-hour shifts with no scheduled days
off. This practice would be inconsistent with the findings of the
studies and recommendations cited in the discussions of proposed Sec.
26.199(d)(1)(iii) and (d)(2)(ii).
Although the NRC expects that the proposed criteria for granting
waivers from the individual work hour controls in proposed Sec.
26.199(d)(3) would significantly reduce the granting of waivers, the
proposed maximum individual work hour requirements of proposed Sec.
26.199(d)(1) would not preclude licensees from scheduling consecutive
10-hour shifts with no days off. In addition, although the collective
work hour controls in proposed Sec. 26.199(f) would limit cumulative
fatigue from broad and extended use of such schedules while plants are
operating, these controls would not apply during the first 8 weeks of
plant outages, and in other circumstances for security personnel, as
detailed in proposed Sec. 26.199(f)(2). Therefore, the proposed work
hour controls of Sec. 26.199(d)(1) and (f) would not effectively
prevent cumulative fatigue for roving outage crews and other transient
workers who predominantly work during plant outages.
By contrast, the long break requirement of proposed Sec.
26.199(d)(2)(ii) would provide an important protection against
cumulative fatigue for individuals who work consecutive outages, as
well as for all individuals who perform the duties listed in proposed
Sec. 26.199(a) during extended plant outages. One stakeholder observed
during one of the public meetings described in Section V that assuring
transient outage workers are not impaired by fatigue is particularly
important because these individuals typically do not have the extensive
training in methods for maintaining reliable human performance that is
provided to permanent plant personnel.
Proposed Sec. 26.199(d)(2)(iii) would be added to further require
licensees to provide individuals with a 48-hour break in any rolling
14-day period. A detailed discussion of the bases for requiring
extended breaks is provided with respect to proposed Sec.
26.199(d)(2)(ii). In addition to the bases for the 24-hour break
requirement, the details of which also apply to this proposed
requirement, a 48-hour break every 14 days is further justified because
the maximum individual work hour requirements of proposed Sec.
26.199(d)(1) and the 24-hour break requirement in proposed Sec.
26.199(d)(2)(ii) would not preclude licensees from scheduling a series
of weeks that required individuals to work six consecutive 12-hour
shifts with only one day off. However, only one day off is insufficient
to recover completely from chronic sleep restriction.
The need for at least two consecutive unrestricted sleep periods to
recover from restricted sleep and periods of extended work hours has
been demonstrated in several studies. Surveys (National Sleep
Foundation, 2001, 2002) and studies (Monk, et al., 2001) of actual
sleep patterns of shiftworkers show that shiftworkers sleep longer on
``weekends'' (i.e., periods of two or more days off), indicating a need
for recovery sleep that is not being met during the workweek. In the
Belenky, et al. (2003) study that was discussed with respect to
proposed Sec. 26.199(d)(2)(ii), the performance of the sleep-
restricted subjects, including those whose sleep periods were
restricted to 7 hours, did not return to baseline levels on all
performance measures, even after 3 recovery nights of 8-hour sleep
periods. Further, in a personal communication on March 22, 2005 (ADAMS
Accession No. ML050870172), Dr. David Dinges stated that he and his
colleagues at the sleep lab at University of Pennsylvania Medical
School are currently conducting large-scale studies of the recovery
process and that preliminary results from these studies appear to
confirm the Belenky, et al. findings. He noted that one night of
unrestricted sleep is generally insufficient because individuals'
circadian rhythms will not permit them to sleep for the 12-14 hours
that may be required to recover from a series of days on which sleep
has been moderately restricted. In addition, Dr. Dinges reported that a
scientific consensus has emerged within the research community that at
least two consecutive nights of unrestricted sleep periods are the
minimum essential for recovery. Two consecutive nights' are required
because, as discussed in Section IV D(2)(c), individuals' circadian
rhythms decrease the length of
[[Page 50593]]
daytime sleep periods and daytime sleep interruptions are common.
The need for longer breaks to mitigate fatigue was also reflected
in recent changes to DOT's regulations for the work hours of commercial
truck drivers. On April 28, 2003, the DOT published final regulations
(68 FR 22456-22517) for hours-of-service for drivers of motor carriers,
which amended 49 CFR 385, 390, and 395. These regulations require a
minimum 34-hour break after any period of 8 consecutive days with no
more than 70 hours on duty. The intent of this 34-hour break is to
provide for two consecutive sleep periods. The regulations also limit
drivers to 11 hours of driving and 14 hours on duty with 10 consecutive
hours off duty each day.
The importance of long breaks is also reflected in work scheduling
guidelines such as EPRI NP-6748, ``Control Room Operator Alertness and
Performance in Nuclear Power Plants.'' With respect to the number of
consecutive shifts, EPRI recommends no more than 6-7 consecutive 8-hour
shifts and no more than 3-4 consecutive 12-hour shifts. With respect to
the number of consecutive days off, EPRI recommends a break of at least
48 hours between any two blocks of shifts and at least one 3-4 day
break every few weeks. Similarly, a panel of independent experts in
fatigue and work scheduling, convened by the NRC (NUREG/CR-4248),
recommended that work schedules should include no more than 7
consecutive 8-hour shifts and at least 2 consecutive days off in any 9
days and a maximum of 4 consecutive 12-hour shifts followed by no fewer
than 4 days off. Proposed Sec. 26.199(d)(2)(iii) would establish a
minimum break requirement that would be somewhat less stringent than
these scheduling guidelines.
In many nations a routine 72-hour work week would be illegal (OTA,
1991). As a consequence, studies of the effects of continuous weeks of
working six consecutive 12-hour shifts are sparse. However, there are a
few studies concerning the work hours and performance of medical
residents who, like many nuclear power plant personnel, perform largely
cognitive tasks. By contrast to the majority of individuals working at
nuclear power plants, medical residents are typically young adults with
few family commitments. This characteristic is important because social
and domestic commitments inevitably limit sleep time (Presser, 2000)
and there are significant decrements in the abilities of middle-aged
men to adapt to the changes in sleep schedules required by shiftwork
compared to younger adults (Monk, Moline and Graeber, 1988; Carrier, et
al., 1997; Dawson and Campbell, 1991). However, despite lifestyle and
age differences between medical residents and nuclear power plant
workers, the underlying physiological processes affected by fatigue are
the same in both groups. Therefore, research on the effects of
cumulative fatigue on the job performance of medical residents is
useful in understanding the potential effects of fatigue on nuclear
power plant personnel, although generalizing the findings of research
conducted with medical residents to nuclear power plant workers likely
underestimates the effects of fatigue on nuclear power plant workers'
job performance because of their greater average age.
Two key publications, (Baldwin, et al., 2003; Baldwin and
Daugherty, 2004) report survey data from more than 3,600 medical
residents. These studies found that almost half of the sample worked
more than 80 hours per week. When the residents who worked more than 80
hours per week were compared to those working fewer than 80 hours, it
was found that the former group had a statistically higher likelihood
of (1) having a serious accident or injury; (2) having a serious
conflict with a co-worker; and (3) making a significant medical error.
Work hours were also significantly correlated with sleep loss and
ratings of stress.
Similarly, two studies were conducted comparing the performance of
medical interns on their traditional schedule, which totaled 77-81
hours per week and included on-call shifts that extended up to 30
hours, with the performance of these same interns during an
intervention schedule. The intervention schedule averaged approximately
65 hours per week and reduced shift lengths to a maximum of 16 hours.
Lockley and colleagues found that interns on the intervention schedule
had less than half the rate of attentional failures during on-call
night shifts compared with their rate of attentional failures while
working on the traditional schedule (Lockley, et al., 2004). In another
study, Landrigan and colleagues found that interns on the traditional
schedule made 35.9 percent more serious medical errors and 56.5 percent
more serious, non-intercepted errors than interns working on the
intervention schedule. The rate of serious errors on the critical care
unit was 22 percent higher during the traditional schedule. Interns
made 20.8 percent more serious medication errors and 5.6 times as many
serious diagnostic errors on the traditional schedule (Landrigan, et
al., 2004).
These studies suggest that nuclear power plant workers who work
long shifts over extended periods are substantially more likely to
commit errors on the job. Fatigue from extended periods of working long
shifts is likely to lead to serious errors, impaired teamwork, and an
increased potential for personal injuries.
Except during the first 2 weeks of a plant outage, proposed Sec.
26.199(d)(2)(iii), in conjunction with the other proposed work hour
limits, would require a schedule very similar to the intervention
schedule for the medical interns. Specifically, proposed Sec.
26.199(d)(2)(iii) would require a 48-hour break in every rolling 14-day
period, effectively limiting individuals who perform the job duties
listed in proposed Sec. 26.199(a)(1)-(a)(4) from working six 12-hour
shifts for more than one week at a time. For example, individuals on
12-hour shifts could work six 12-hour shifts during week 1, followed by
five 12-hour shifts during week 2. As a result, these individuals would
average 66 hours over the two-week period, and would be limited by
proposed Sec. 26.199(d)(1)(i) to working no more than 16 hours in any
24-hour period.
In addition to being important for permanent workers at nuclear
power plants, the 48-hour break requirement would be critical to
prevent and mitigate cumulative fatigue in roving outage crews and
other transient workers who predominantly work during plant outages
when the collective work hour controls in proposed Sec. 26.199(f)
would not frequently apply. During the stakeholder meetings discussed
in Section V, many stakeholders expressed a strong desire for transient
workers to be subject to work hour controls. The NRC staff considered
subjecting transient workers to long-term work hour controls. However,
collective work hour controls and 48-hour average group limits would
not be practical, because these individuals typically work during
outages when significant workloads occur. The NRC staff further
considered individual long-term (quarterly and yearly) work hour limits
for transient workers. However, industry representatives strongly
objected because these transient individuals move from one licensee to
another, and the burden of obtaining work hour information for all of
these individuals from other licensees would be extremely high. In part
because of the practical difficulties of controlling long-term work
hours for transient individuals, the NRC developed the 48-hour break
requirement as a replacement for long-term work hour limits for
transient individuals.
[[Page 50594]]
The NRC further considered that some transient personnel include
licensee employees and long-term C/Vs. Many of these individuals may
move from site-to-site within a fleet during plant outage periods. For
large fleets, some individuals may work much of the spring and fall
outage seasons under only the individual work hour limits and break
requirements in proposed Sec. 26.199(d). The proposed 48-hour break
requirement would be the single requirement that would prevent such
individuals from working 72 hours per week for extended periods. The
proposed 48-hour break requirement would also provide necessary breaks
for all individuals who perform the duties listed in proposed Sec.
26.199(a) during extended plant outages of more than 2 weeks in
duration. In this case, the proposed 48-hour break requirement would
again be the single requirement that would prevent individuals from
working 72 hours per week for the entire first 8 weeks of any plant
outage [collective work hour limits would apply after the first 8 weeks
of any plant outage, as discussed with respect to proposed Sec.
26.199(f)]. Working 72 hours per week for extended periods is
inconsistent with the research cited in this section with respect to
proposed Sec. 26.199(d)(2)(i) and (d)(2)(ii), nor does the NRC believe
it is consistent with providing reasonable assurance that individuals
are fit to perform their duties. The 48-hour break requirement of
proposed Sec. 26.199(d)(2)(ii) would provide an important protection
against cumulative fatigue for individuals who work consecutive outages
and outages that are longer than two weeks.
Proposed Sec. 26.199(d)(3) would be added to permit licensees to
authorize waivers from the work hour controls for individuals in
proposed Sec. 26.199(d)(1) and (d)(2) for conditions that meet two
criteria, which would be specified in the proposed paragraph. Exceeding
the individual work hour limits would be justified for limited
circumstances in which compliance with the work hour controls could
have immediate adverse consequences for the protection of public health
and safety or the common defense and security. Limited use of waivers
also would be consistent with the Commission's position stated in the
NRC's Policy on Worker Fatigue. However, as specified in proposed Sec.
26.199(d)(3)(ii), the NRC would expect licensees to grant waivers only
to address circumstances that the licensee could not have reasonably
controlled.
Proposed Sec. 26.199(d)(3)(i)(A) would be added to establish one
of two criteria in the proposed rule for granting a waiver from the
individual work hours controls. Specifically, proposed Sec.
26.199(d)(3)(i)(A) would require that an operations shift manager must
determine that the waiver is necessary to mitigate or prevent a
condition adverse to safety, or a security shift manager must determine
that the waiver is necessary to maintain the security of the facility,
or a site senior-level manager with requisite signature authority must
make either determination.
The NRC's Policy on Worker Fatigue recognized that ``very unusual
circumstances may arise requiring deviation from the above [work hour]
guidelines.'' In SECY-01-0113, the NRC noted that the frequency of
guideline deviations at a substantial proportion of sites appeared to
be inconsistent with the intent of the policy. The NRC believes that
the authority to grant deviations from the work hour guidelines was
abused by some licensees. Proposed Sec. 26.199(d)(3)(i)(A) would more
clearly articulate the NRC's expectations with respect to exceeding the
work hour limits, which are that licensees must limit the granting of
waivers from the work hour limits to circumstances in which it is
necessary to prevent or mitigate a condition adverse to safety or to
maintain the security of the plant. The proposed criterion would limit
waivers to conditions that are infrequent while permitting waivers that
are necessary for safety or security. For example, proposed Sec.
26.199(d)(3)(i)(A) would permit a licensee to grant a waiver from a
work hour control on the basis that the waiver is necessary to prevent
a condition adverse to safety, if compliance with the work hour
controls would cause the licensee to be in violation of other NRC
requirements, such as the minimum on-site staffing requirements in 10
CFR 50.54(m), or would delay the recovery of failed plant equipment
that is necessary for maintaining plant safety. Similarly, the NRC
would consider it appropriate to grant a waiver from the proposed work
hour controls on the basis that it is necessary to prevent a condition
adverse to safety, if compliance with the work hour controls would
cause a forced reactor shutdown, power reduction, or other similar
action, as a result of exceeding a time limit for a technical
specification Limiting Condition for Operation (LCO). LCOs require
nuclear power plant licensees to take certain actions to maintain the
plant in a safe condition under various conditions, including
malfunctions of key safety systems.
The criterion for granting waivers in proposed Sec.
26.199(d)(3)(i)(A) was the subject of considerable stakeholder comment
and discussion during the public meetings described in Section V.
Industry representatives stated that the criterion is overly
restrictive because it would prohibit the granting of waivers for
conditions that could be cost beneficial to the licensee without a
substantive decrease in safety. However, as discussed with respect to
proposed Sec. 26.199(d)(2) and (d)(3), the potential for worker
fatigue in conditions that would require a waiver is substantial
(Baker, et al., 1994; Dawson and Reid, 1997; Stephens, 1995; Strohl,
1999). Therefore, the NRC does not believe that licensees can
reasonably justify the performance of risk-significant functions by
individuals who have worked hours in excess of the proposed limits on
the basis that granting the waiver would not have an adverse impact on
safety or security. The basis for not incorporating industry's comment
on this provision is detailed in Section V.
Proposed Sec. 26.199(d)(3)(i)(A) would further require that an
operations shift manager or a senior-level site manager with requisite
signature authority must make the determination that a waiver is
necessary to mitigate or prevent a condition adverse to safety.
Similarly, the proposed rule would require that a security shift
manager, or a senior-level site manager with requisite signature
authority, must make the determination that a waiver is necessary to
maintain the security of the facility. Operations shift managers and
security shift managers have the requisite knowledge and qualifications
to make the respective safety or security determinations, and making
such determinations would be consistent with the scope of duties
currently performed by individuals in these positions. The NRC
considered industry stakeholder comments during the public meetings
described in Section V, expressing concern that limiting the authority
to approve waivers to operations shift managers and security shift
managers could contribute to overburdening individuals in these
positions and would prevent distributing the administrative burden of
granting a waiver to other qualified individuals. The NRC also
considered other stakeholder comments concerning the need to ensure
that the determinations are made by individuals who would not be unduly
influenced by schedule pressures. The NRC noted that authority to
authorize deviations had been delegated by some licensees to
organizational levels that appeared to be inconsistent with the
guidelines in the
[[Page 50595]]
NRC's Policy on Worker Fatigue for work hour deviation authorizations,
which indicate that deviations from the guidelines should be authorized
by the plant manager or plant manager designee. Accordingly, proposed
Sec. 26.199(d)(3)(i)(A) would permit senior site managers with the
signature authority of operations shift supervisors to make the safety
determinations that would be required to grant waivers and senior site
managers with the signature authority of security shift supervisors to
make security determinations required to grant waivers.
Proposed Sec. 26.199(d)(3)(i)(B) would be added to establish the
second of two proposed criteria for granting a waiver from the
individual work hour controls of proposed Sec. 26.199(d)(1) and
(d)(2). Proposed Sec. 26.199(d)(3)(i)(B) would require that a
supervisor, who is qualified to direct the work to be performed by the
individual to whom the waiver will be granted and is trained in
accordance with the requirements of proposed Sec. Sec. 26.29 and
26.197(c), must assess the individual face to face and determine that
there is reasonable assurance that the individual will be able to
safely and competently perform his or her duties during the additional
work period for which the waiver will be granted.
These determinations would require knowledge of the specific skills
that are necessary to perform the work and the conditions under which
the work will be performed in order to assess the potential for fatigue
to adversely affect the ability of an individual to safely and
competently perform the work. This knowledge is generally limited to
individuals who are qualified to direct the work. The training required
by proposed Sec. Sec. 26.29 and 26.197(c) would provide the knowledge
and abilities that would be essential for a supervisor to make valid
assessments in this regard. Among other FFD topics, the proposed
training would address the contributors to worker fatigue and decreased
alertness in the workplace, the potential adverse effects of fatigue on
job performance, and the effective use of fatigue countermeasures.
Accordingly, the proposed training would be necessary for individuals
to perform these assessments.
Proposed Sec. 26.199(d)(3)(i)(B) would further require that
supervisors must perform the assessment face to face with the
individual that he or she is assessing for the waiver. This proposed
requirement would ensure that the supervisor who is performing the
assessment has the opportunity to observe the individual's appearance
and behavior to note indications of fatigue (e.g., decreased facial
tone, rubbing of eyes, slowed speech) and interact with the individual
to assess the individual's ability to continue to safely and
competently perform his or her duties during the period for which the
waiver would be granted.
Proposed Sec. 26.199(d)(3)(i)(B) would also require that the
supervisory assessment must address, at a minimum, the potential for
acute and cumulative fatigue, considering the individual's work history
for at least the past 14 days and the potential for circadian
degradations in alertness and performance, considering the time of day
for which the waiver will be granted. The potential for acute fatigue
can be practically assessed by estimating the total number of
continuous hours the individual will have worked by the end of the work
period for which the waiver is being considered. The potential for
cumulative fatigue can be practically assessed by reviewing the
individual's work schedule during the past 14 days to determine (1)
whether the individual had adequate opportunity to obtain sufficient
rest, considering the length and sequencing of break periods; (2)
whether the available sleep periods occurred during the night or at
other times when sleep quality may be degraded; and (3) the potential
for transitions between shifts (e.g., from days to nights) to have
interfered with the individual's ability to obtain adequate rest. The
potential for circadian degradations in alertness and performance can
be practically assessed by considering the time of day or night during
which the work would be performed, as well as the times of day of the
individual's recent shift schedules. Proposed Sec. 26.199(d)(3)(i)(B)
would in effect require supervisors to address the three work schedule
factors (i.e., shift timing, shift duration, and speed of rotation)
that are generally considered to be the largest determinants of worker
fatigue (Akerstedt, 2004; McCallum, et al., 2003; Mallis, et al., 2002;
Folkard and Monk, 1980; Rosa, 1995; Rosa, et al., 1996). In determining
the scope of the proposed assessment, the NRC also considered the need
for licensees to be able to focus the assessment on information that
would be readily available and could be verified.
Proposed Sec. 26.199(d)(3)(i)(B) would further require that the
supervisory assessment for granting a waiver must address the potential
for fatigue-related degradations in alertness and performance to affect
risk-significant functions, and whether it would be necessary to
establish controls and conditions under which the individual will be
permitted to perform work. This proposed requirement is consistent with
the NRC's Policy on Worker Fatigue, which states that ``the paramount
consideration in such authorizations shall be that significant
reductions in the effectiveness of operating personnel would be highly
unlikely.'' However, proposed Sec. 26.199(d)(3)(i)(B) would require
the supervisor to identify any risk-significant functions that may be
compromised by worker fatigue, thereby focusing the assessment on
worker activities that have the greatest impact on the protection of
the public, considering the types of skills and abilities that are most
sensitive to fatigue-related degradations.
Proposed Sec. 26.199(d)(3)(i)(B) would also require the supervisor
to identify any additional controls and conditions that he or she
considers necessary to grant the individual a waiver from a work hour
control. For example, applicable controls and conditions may include,
but would not be limited to: (1) Peer review and approval of assigned
job tasks; (2) assignment of job tasks that are non-repetitive in
nature; (3) assignment of job tasks that allow the individual to be
physically active; and (4) provisions for additional rest breaks. The
proposed requirement to consider establishing controls and conditions
would be necessary to ensure that licensees take steps to mitigate
fatigue from an extended work period and reduce the likelihood of
fatigue-related errors adversely affecting public health and safety or
the common defense and security.
Proposed Sec. 26.199(d)(3)(ii) would be added to require
licensees, to the extent practicable, to grant waivers only in
circumstances that the licensee could not have reasonably controlled.
This proposed requirement would be necessary because conditions meeting
the waiver criteria that are specified in proposed Sec.
26.199(d)(3)(i) could routinely result from inadequate staffing or work
planning. Licensees have authorized deviations from their technical
specification limits on work hours for these reasons in the past.
However, because of the significant adverse effects of worker fatigue,
as detailed in Section IV. D, waivers should be used infrequently and
only when necessary to protect the public. Licensees should take all
reasonable care to ensure the use of waivers is minimized. Therefore,
proposed Sec. 26.199(d)(3)(ii) would prohibit the use of waivers in
lieu of adequate staffing or proper work planning, for example, but
would permit the use of waivers for circumstances that the licensee
could
[[Page 50596]]
not have reasonably controlled, which may include, but would not be
limited to, equipment failures or a sudden increase in the personnel
attrition rate.
Proposed Sec. 26.199(d)(3)(iii) would be added to require that the
face-to-face supervisory assessment required in proposed Sec.
26.199(d)(3)(i)(B) must be performed sufficiently close in time to the
period during which the individual will be performing work under the
waiver to ensure that the assessment would provide a valid assessment
of the potential for worker fatigue during the extended work period.
This proposed requirement would be necessary because worker alertness
and the ability to perform can change markedly over several hours
(Baker, et al., 1990; Dawson and Reid, 1997; Frobert, 1997; Folkard and
Monk, 1980; Rosa, 1995). These changes can be particularly dramatic if
fatigue from sustained wakefulness coincides with circadian periods of
decreased alertness (Baker, et al., 1990; Gander, et al., 1998;
Rosekind, 1997; Folkard and Tucker, 2003; Carrier and Monk, 2000).
Therefore, the proposed rule would require licensees to conduct
supervisory assessments within a time period that provides reasonable
assurance that the individual's condition will not substantively change
before work is performed under the waiver.
Proposed Sec. 26.199(d)(3)(iii) would establish a period of 4
hours before the individual begins working under the waiver as the
period within which the supervisory assessment must be performed. In
establishing a maximum time period the NRC considered several factors.
Conducting the assessment as close in time as practical to the period
during which the individual will perform work under the waiver would
provide the greatest assurance of a valid assessment. However,
conducting the assessment immediately before the individual will begin
performing work under the waiver could, in some circumstances, cause
the timing of assessments to conflict with the conduct of shift
turnovers and other practical administrative and operational
constraints. Additionally, assessments for granting waivers from the
longer-term individual limits (e.g., the maximum number of work hours
in 7 days) would be less sensitive to the specific timing of the
assessment. However, certain licensees have periodically authorized
blanket deviations from technical specification work hour limits days
and weeks in advance of the actual performance of the work. A maximum
limit of 4 hours would address the need for an enforceable requirement
that would provide reasonable assurance of valid assessments, and would
take into account the relevant technical and practical considerations.
An added benefit of the proposed requirement is that it would prevent
the simultaneous granting of blanket waivers for large groups of
individuals that do not take into account each individual's level of
fatigue.
Proposed Sec. 26.199(d)(3)(iv) would be added to require licensees
to document the bases for granting waivers from the individual work
hour controls of proposed Sec. 26.199(d)(1) and (d)(2). The proposed
paragraph would require licensees to document the circumstances that
necessitate the waiver; a statement of the scope of work and time
period for which the waiver is approved; and the bases for the
determinations that would be required by proposed Sec.
26.199(d)(3)(i). The proposed documentation would be necessary to
support NRC inspections of compliance with requirements for granting
waivers from the work hour limits as well as for the licensee self-
assessments of the effectiveness of implementing work hour controls
that would be required under proposed Sec. 26.199(j) [Reviews].
Proposed Sec. 26.199(e) [Self-declarations during extended work
hours] would be added to require licensees to take immediate action in
response to a self-declaration [as discussed with respect to proposed
Sec. 26.197(b)(1)] by an individual who is working under, or being
considered for, a waiver from the work hour controls in proposed Sec.
26.199(d)(1) and (d)(2). Licensees would be required to immediately
stop the individual from performing any duties listed in proposed Sec.
26.199(a) unless the individual is required to continue performing
those duties under other requirements of 10 CFR Chapter I, such as the
minimum control room staffing requirements in 10 CFR 50.54(m). If other
requirements make it necessary for the individual to continue working,
the proposed paragraph would require the licensee to immediately take
action to relieve the individual. For example, the licensee would
immediately begin a call-in procedure for another individual to fill
the required position and remove the individual from duties as soon as
relief becomes available.
The proposed rule would add this requirement because correct
performance of the job duties specified in proposed Sec. 26.199(a) is
of critical importance in maintaining public health and safety and the
common defense and security. In addition, there is a significantly
increased potential for fatigue-related errors when individuals work
more than the maximum work hours or obtain less rest than the minimum
rest requirements of proposed Sec. 26.199(d)(1) and (d)(2).
Individuals who would be working extended hours under a waiver would
have a clear and legitimate basis for a self-declaration of being unfit
for duty because of fatigue. Further, by self-declaring fatigue, the
individual would have effectively provided an assessment of his or her
ability to continue to safely and competently perform these critical
duties. Several studies have indicated a tendency for individuals to
underestimate their level of fatigue (Wylie, et al., 1996; Dinges,
1995; Rosekind and Schwartz, 1988). Therefore, it is very likely that
an individual who would make a self-declaration of fatigue is
potentially more impaired than he or she realizes.
The proposed rule would not require licensees immediately to
relieve an individual who self-declares when it is necessary for the
individual to continue performing his or her duties under other
requirements of 10 CFR Chapter I, because the failure to meet minimum
staffing or similar requirements would, in the majority of cases, have
a greater potential to adversely affect public health and safety and
the common defense and security than permitting a fatigued individual
to continue performing his or her duties for a limited period of time.
Further, in these circumstances, licensees could implement any fatigue
mitigation strategies they deem necessary while the individual remains
on duty. Fatigue mitigation measures in these circumstances may
include, but would not be limited to, controls on the type of work that
the individual may perform until he or she is relieved (e.g., physical
or mental, tedious or stimulating, individual or group, risk-
significant or not) and an increased level of supervision (continuous
or intermittent) and other oversight (e.g., peer checks, independent
verifications, quality assurance reviews, and operability checks).
Proposed Sec. 26.199(e)(1) would be added to permit licensees to
reassign an individual who has made a self-declaration of fatigue to
perform other duties than those specified in proposed Sec. 26.199(a).
The proposed rule would include this flexibility because, although an
individual may not be fit to perform the activities specified in
proposed Sec. 26.199(a), the individual may be able to safely and
competently perform other duties. Other duties may include, but would
not be limited to, tasks that require skills that are less
[[Page 50597]]
susceptible to degradation from fatigue or do not have the potential to
adversely affect public health and safety or the common defense and
security if the individual commits fatigue-related errors. The proposed
rule would permit licensees to reassign individuals who have made a
self-declaration of fatigue to other duties, if the results of a
fatigue assessment (as would be required under proposed Sec. 26.201
[Fatigue assessments]) indicate that he or she is fit to perform them,
because permitting the individual to remain at work and continue
performing such duties would not have the potential to adversely impact
public health and safety or the common defense and security.
However, proposed Sec. 26.199(e)(2) would be added to require the
licensee to permit or require an individual who has made a self-
declaration to take a rest break of at least 10 hours before the
individual returns to performing any duties listed in proposed Sec.
26.199(a). The proposed rule would include this requirement to ensure
that individuals who have self-declared would be given an opportunity
to sleep before they are permitted to resume performing any duties that
have the potential to adversely affect public health and safety or the
common defense and security. Sleep is widely considered the only non-
pharmacological means of reducing fatigue. As discussed with respect to
proposed Sec. 26.199(d)(2)(i), a 10-hour rest break generally allows
individuals to obtain the 7-8 hours of sleep that is recommended by
most experts for maintaining human performance (National Sleep
Foundation, 2001; Dinges, et al., 1997; Belenky, et al., 2003;
Akerstedt, 2003; Monk, et al., 2000; Rosekind, et al., 1997; Rosa,
1995).
Although one sleep period of 7-8 hours may be insufficient to
ensure full recovery from excessive fatigue, nothing in the proposed
rule would preclude an individual in this circumstance from making a
second self-declaration of fatigue, if the individual believes that he
or she remains unable to safely and competently perform his or her
duties following the rest break. Section I. B of the May 10, 2002, NRC
Regulatory Issue Summary (RIS) 2002-07: ``Clarification of NRC
Requirements Applicable to Worker Fatigue and Self-Declarations of
Fitness-for-Duty,'' addressed the applicability of the protections of
10 CFR 50.7, ``Employee Protection,'' to workers who self-declare that
they are unfit for duty as a result of fatigue.
Proposed Sec. 26.199(f) [Collective work hour limits] would be
added to require licensees to control the collective work hours of each
group of individuals who are performing the job duties listed in
proposed Sec. 26.199(a) and ensure that the collective work hours of
each job duty group do not exceed an average of 48 hours per person per
week in any averaging period. (The proposed rule's requirements for
calculating collective work hours are discussed with respect to
proposed Sec. 26.195(b)(2) [Collective work hours].) The requirements
of proposed Sec. 26.199(f) would address the control of work hours
over extended periods of time, by contrast to the short-term work hour
controls in proposed Sec. 26.199(d) [Work hour controls for
individuals].
The objectives of the 48-hour collective limit during normal plant
operations would be to: (1) ensure that the routine work hours of
individuals who are performing the duties listed in proposed Sec.
26.199(a)(1)-(a)(5) do not adversely affect their abilities to safely
and competently perform their duties; (2) define an enforceable upper
limit for the nominal 40-hour work-week policy stated in GL 82-12; and
(3) continue to permit licensees to manage overtime in a manner that
reflects the differing desires and capabilities of individuals with
respect to work hours.
The proposed collective work hour controls would ensure that
licensees manage the potential for cumulative fatigue (i.e., fatigue
from successive weeks or months of overwork or inadequate rest) to
adversely affect the abilities of individuals to perform functions that
are important to maintaining the safety and security of the plant. The
48-hour collective work hour limit would prevent excessive use of the
maximum work hours and minimum rest breaks that would be permitted
under the proposed individual work hour controls. In addition,
proactively controlling work hours to a group average of no more than
48 hours per week would likely reduce the need for licensees to grant
waivers of the individual limits in proposed Sec. 26.199(d)(1) and
(d)(2). Individuals would be better rested and less susceptible to
cumulative fatigue from the increased work hours that are common during
outages and are necessary to augment security staffing during increased
threat conditions, during which times licensees would not be required
to implement group work hour controls, subject to the restrictions
listed in proposed Sec. 26.199(f)(1)-(f)(5). Therefore, the 48-hour
collective work hour limit would be essential for limiting cumulative
fatigue and would augment other important elements of licensees'
fatigue management programs.
The collective work hour control concept would be consistent with a
fundamental objective of the NRC's Policy on Worker Fatigue. The
Policy, promulgated via GL 82-12, is intended to ensure that there are
a sufficient number of operating personnel available to ``maintain
adequate shift coverage without routine heavy use of overtime.''
Routine overtime can cause cumulative fatigue, thereby degrading
workers' abilities to safely and competently perform their tasks. The
proposed requirement would, in effect, limit groups of individuals to
no more than 20 percent overtime in excess of the nominal 40-hour work
week objective of the NRC's Policy on Worker Fatigue during the periods
in which the proposed requirement would be applicable (typically during
normal plant operations).
The collective work hour controls of proposed Sec. 26.199(f) would
also codify, in part, the requirements established by Order EA-03-038
for the control of work of hours for specified nuclear power plant
security personnel (SRM-COMSECY-03-0012, dated March 31, 2003). As
described with respect to Sec. 26.199(f)(2), the NRC has received
numerous allegations from nuclear security officers that certain
licensees have required them to work excessive amounts of overtime over
long periods due to the post-September 11, 2001, threat environment.
These individuals questioned their readiness and ability to perform
their required job duties because of the adverse effects of cumulative
fatigue. The NRC reviewed the actual hours worked by security personnel
and determined that, in the vast majority of cases, individual work
hours did not exceed the guidelines specified in the NRC's Policy on
Worker Fatigue. However, the review confirmed that individuals had been
working up to 60 hours per week for extended periods. Individual
concerns regarding their fitness for duty, in light of work schedules
that did not exceed the specific guidelines of the policy, as well as
relevant technical research supporting the basis for cumulative
fatigue, led the NRC to conclude that the work hour guidelines of the
Policy are inadequate for addressing cumulative fatigue. The NRC
obtained additional support for this conclusion following a review of
worker fatigue concerns and work hours during a long-term outage at the
Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003,
dated March 31, 2004, ADAMS Accession No. ML040910335).
Through public interactions during the development of Order EA-03-
038, the NRC developed a collective work
[[Page 50598]]
hour requirement, rather than a limit on individual work hours, in
response to stakeholder input regarding differences among individuals
in their abilities and desires to work overtime. Similarly, the
proposed rule would permit a group of workers who are performing
similar duties to average 48 hours of work over a period not to exceed
13 weeks [proposed requirements for calculating collective work hours
are discussed with respect to proposed Sec. 26.199(b)(2)]. Because the
proposed limit would be imposed on a job duty group's average number of
work hours during an averaging period, licensees would continue to be
permitted to distribute overtime among their workers based on their
assessment of individuals' abilities and desires to work overtime. The
proposed averaging methodology would not unduly limit individuals from
working voluntary overtime, and would effectively result in adequate
opportunities for days off and limited forced overtime. As discussed
with respect to proposed Sec. 26.199(b)(2), requiring licensees to
average collective work hours over a period up to 13 weeks in length
would establish a limit on the long-term scheduling of work hours that
would support timely identification and corrective action for
conditions that could contribute to cumulative fatigue, but would not
be overly sensitive to short-term variations in workload. Short-term
variations in workload have limited potential for causing cumulative
fatigue.
The NRC considered several types and sources of information in
deciding to propose a collective work hour limit of 48 hours per person
per week. These included: (1) Past recommendations from experts and
expert panels on work scheduling and maintaining worker alertness in
the nuclear industry; (2) surveys of nuclear power plant workers on
their desire and ability to work overtime; (3) data on the amount of
overtime worked by security personnel; and (4) the requirements and
practices in other industries.
Two of the most comprehensive documents on worker fatigue in the
U.S. nuclear industry are EPRI NP-6748 (Baker, et al., 1990) and NUREG/
CR-4248. The collective work hour limit is a new concept developed to
meet the NRC's objectives, while also addressing the unique
circumstances and specific concerns of the stakeholders. As a
consequence, neither of the documents provides specific guidelines for
establishing collective work hour limits. Nevertheless, the documents
contain information and guidelines relevant to the proposed
requirement. Collectively, the shift scheduling guidelines of EPRI NP-
6748 and NUREG/CR-4248 suggest a maximum routine work schedule of 44-46
hours per week. This maximum includes an assumed turnover time of 30
minutes per shift. The NRC also considered the recommendations of
experts concerning the use of overtime. The expert panel that developed
the guidelines for NUREG/CR-4248 also addressed use of overtime and
recommended an individual limit of 213 hours per month, including shift
turnover time. The expert panel emphasized that overtime should not be
approved for an entire crew, indicating that this individual maximum on
overtime should not be a group norm. The collective work hour limit of
48 hours per person per week would establish a requirement that is in
the middle of the range of work hours defined by the maximum routine
scheduling limits and maximum individual overtime, and also provides
for individual differences with respect to vulnerability to fatigue.
The expert panel further recommended that the NRC authorize no more
than 400 hours of overtime in a year. A limit of 400 hours of overtime
annually is very similar to a 48-hour average (i.e., 52 weeks x 8 hours
= 416 hours).
In addition to considering the opinions of experts in work
scheduling and fatigue, the NRC staff considered the opinions of
individuals who work in nuclear power plants. These opinions were
expressed in surveys conducted by PROS and EPRI.
In 2002, PROS surveyed the attitudes of its members towards work
hours and the development of a proposed rule concerning fatigue of
workers at nuclear power plants (ADAMS Accession No. ML05270310). One
of the survey questions was, ``What is your personal tolerance for
overtime?'' The responses indicated that 75 percent of the respondents
had a ``tolerance'' for up to 350 hours per year. Only 13 percent
expressed a tolerance for more than 350 hours of overtime.
The work conducted in the development of EPRI NP-6748 also included
a survey of operators. The results were consistent with the PROS
survey, indicating that the amount of overtime that operators wanted to
work ranged from 100 to 400 hours per year. Similar results were
obtained in a survey of nuclear power plant personnel in the United
Kingdom.
A 48 hour per person per week collective work hour limit would
permit job duty groups to average approximately 400 hours of overtime,
or 2400 hours of work, in a year. Therefore, the proposed collective
work hour limit would be consistent with the upper extreme of overtime
hours for which nuclear power plant personnel have expressed a
tolerance. In addition, the proposed collective work hour limit would
be less restrictive than the limit implied by worker opinions because
the 48-hour average would exclude hours worked during the first 8 weeks
of outages.
In addition to expert and worker opinions, the NRC considered
industry practices concerning the use of overtime for security
personnel. The NRC collected work scheduling data for security
personnel at all nuclear power plants following the events of September
11, 2001, as part of the process of evaluating the need to require
licensees to implement compensatory measures to address security
personnel fatigue. The NRC's analysis, as described in letters from the
NRC to licensees (e.g., ADAMS Accession No. ML031880257), indicated
that at some of the sites (31 percent), security personnel worked more
than 55 hours per week and at a few sites (11 percent) they worked 60
hours or more per week. The data also indicated that at the majority of
the sites (58 percent) security personnel typically worked 50 hours per
week or fewer. The NRC also reviewed work hours data collected by NEI
(ADAMS Accession No. ML003746495) and found that, although there was
substantial variation among sites, the average annual overtime for
licensed operators was 375 hours and 361 hours for non-licensed
operators. These findings suggest that an average work week of 48 hours
is an achievable objective for security personnel as well, although it
was not a current practice at a small fraction of nuclear power plants.
The proposed 48-hour per person per week collective work hour limit
would be comparable to restrictions on workers in other industries
within the U.S. and the limits imposed by other countries that regulate
overtime for nuclear power plant workers. The NRC staff considered that
cumulative fatigue of nuclear power plant personnel is addressed in
several other countries through individual monthly and/or annual work
hours limits on overtime. These limits, summarized in Table 6 of
Attachment 1 to SECY-01-0113, are generally more restrictive than the
proposed 48-hour collective work hour limit because they permit fewer
hours of work and provide less flexibility because the limits apply to
individuals rather than groups (e.g., Finland limits overtime to 250
hours per year). Table 5 of Attachment 1 to SECY-01-0113 includes a
summary of limits on work hours in other industries in the U.S.
[[Page 50599]]
The NRC also considered the requirements of the European Union (EU)
Working Times Directive (WTD) (Council Directive, 1993). The WTD
establishes requirements concerning the working hours of workers across
various industries in EU member nations. The WTD establishes a
requirement that ``workers cannot be forced to work more than 48 hours
per week averaged over 17 weeks.''
In addition, the amount of overtime permitted by the proposed 48-
hour collective work hour limit would be greater than the amount used
in most continuous operations. Circadian Technologies Incorporated, a
consulting firm that is expert in fatigue management, regularly surveys
U.S. and Canadian companies conducting 24/7 operations. Their 2000
survey of 550 major companies indicates that shift workers at 89
percent of the companies surveyed averaged less than 400 hours of
overtime per year (Circadian Technologies Incorporated, 2000).
Circadian Technologies Incorporated noted that average overtime for
workers in extended operations in the U.S. was 12.6 percent above the
standard work-week in the first 8 months of 2003, with utilities
averaging 14.9 percent (Circadian Technologies Incorporated, 2003).
Therefore, the proposed 48-hour collective work hour requirement
would establish an appropriate upper limit on work hours while the
plant is operating. The proposed limit would be consistent with expert
and worker opinions concerning work hours, provide substantial licensee
flexibility, and recognize individual differences in the ability to
work overtime while remaining fit to safely and competently perform
duties.
Proposed Sec. 26.199(f)(1) would be added to exclude the first 8
weeks of plant outages from the collective work limit in proposed Sec.
26.199(f) for the job duty groups that are specified in proposed Sec.
26.199(a)(1)-(a)(4) (i.e., certain operations, maintenance, chemistry,
health physics, and fire brigade personnel). During the first 8 weeks
of a plant outage, proposed Sec. 26.199(d) would require these
individuals to be subject to individual work hour controls. After the
first 8 weeks of a plant outage, proposed Sec. 26.199(f)(1) would
require licensees to resume controlling the work hours of these
individuals in accordance with the collective work hour limit in
proposed Sec. 26.199(f).
The collective work hour limits of proposed Sec. 26.199(f) would
address the long-term control of work hours while permitting the
occasional use of limited overtime for circumstances such as equipment
failure, personnel illness, or attrition. The NRC proposes to address
the control of work hours during short- and medium-length outages
separately and permit licensees to waive the collective work hour
controls for the first 8 weeks of an outage in proposed Sec.
26.199(f)(1). In developing the proposed permission to exclude the
first 8 weeks of an outage from the collective work hour limits, the
NRC considered several factors, including current policy, the bases for
the policy, and lessons learned from the policy implementation.
The NRC's Policy on Worker Fatigue provides guidelines for
controlling work hours, ``on a temporary basis,'' during periods
requiring substantial overtime. The Policy reflects the NRC's
recognition that outages are unique, relatively short-term, and involve
levels of activity that are substantially higher than most non-outage
operating periods. The policy also reflects the NRC's understanding
that, although individuals are capable of working with limited rest
without degraded performance for short periods of time, research has
shown that the ability to sustain performance without adequate rest is
clearly limited (Knauth and Hornberger, 2003; Pilcher and Huffcutt,
1996; Van Dongen, et al., 2003), as discussed in Section IV. D.
However, as noted in SECY-01-0113, Attachment 1, the NRC has never
defined the term, ``temporary basis,'' as used in the Policy. As a
result, licensees have relied on this phrase in the guidelines to
permit extended work hours for periods ranging from a few days to more
than a year. Industry experience with conditions such as sustained
plant shutdowns and the increased work hours of security personnel
following the terrorist attacks of September 11, 2001, have
demonstrated the need for the NRC to establish clearer and more readily
enforceable requirements limiting the sustained use of extended work
hours.
Differences between individuals, job demands, and work-rest
schedules can each have a substantial effect on the period of time that
an individual can work without compromising his or her ability to
safely and competently perform duties. As a result, studies of work
scheduling and fatigue provide insights into the potential for
cumulative fatigue of workers, but do not provide a direct basis for
establishing the maximum acceptable period for excluding plant outage
work hours from the collective work hour controls. In setting the
exclusion period for plant outages at 8 weeks, the NRC considered that,
by the end of 8 weeks of work at the limits permitted by proposed Sec.
26.199(d), individuals who are performing the duties specified in
proposed Sec. 26.199(a)(1)-(a)(4) will have (1) worked 540 hours,
including more than 200 hours of overtime, and (2) missed as many as 17
normally scheduled days off. The loss of the 17 normally scheduled days
off would be a reduction of 60 percent in the time available to recover
and prevent cumulative fatigue. Further, with each passing week of an
outage involving increased work hours and decreased time off, deferring
daily living obligations becomes increasingly difficult, causing
increased pressure on individuals to reduce their sleep time in order
to meet the demands of both work and daily life, resulting in an
increased potential for cumulative fatigue.
In addition to considering the potential for cumulative fatigue,
the NRC considered current industry data on the duration of plant
outages in determining whether the cost to licensees imposed by the
proposed 8-week outage exclusion period are justified in terms of the
benefit. The average outage duration, as indicated by outage data from
2000-2002, is approximately 39 days (Information System on Occupational
Exposure Database, ADAMS Accession No. ML050190016). Eighty-nine
percent of plant outages during this period were less than 8 weeks in
duration. In reviewing the frequency of outages, by duration, the NRC
found that it would be necessary to increase the exclusion period
substantially to address a marginal number of additional outages of
longer lengths. This increase in the exclusion period would
substantially increase the period of time that work hours would not be
controlled by the proposed 48-hour collective work hour limit, which
would be the proposed rule's principal requirement to prevent
cumulative fatigue. During the exclusion period, individuals would only
be assured of a 24-hour break every 7 days and a 48-hour break every 14
days, under the individual work hour limits in proposed Sec.
26.199(d)(1) and (d)(2). Individuals who work 12-hour shifts would
average 66 hours per week, a rate of more than 150 percent of their
normally scheduled hours with less than half of their normally
scheduled days off for recovery, for a period that would exceed 2
months. These extended work hours would substantively increase the
potential for cumulative fatigue and fatigue-related personnel errors.
By contrast, decreasing the exclusion period to less than 8 weeks would
increase the number of
[[Page 50600]]
outages that would be, in part, subject to the collective work hour
controls, potentially increasing the duration and cost of those
outages. Decreasing the exclusion period by 1 or 2 weeks could also
decrease the potential for cumulative fatigue, but the magnitude of the
decrease would be difficult to quantify and the benefit would unlikely
justify the costs.
Excluding the first 8 weeks of an outage would be consistent with
the NRC's objective of ensuring that licensees provide adequate shift
coverage without routine heavy use of overtime. The proposed exclusion
period would be limited to plant outages, which occur regularly, but
with limited frequency. In addition, the proposed rule would limit the
duration of the exclusion period to 8 weeks in order to limit the
potential for cumulative fatigue.
Proposed Sec. 26.199(f)(2)(i) would be added to establish a
collective work hour limit of 60 work hours per person per week for
personnel who are performing the job duties specified in proposed Sec.
26.199(a)(5) (i.e., security personnel) during the first 8 weeks of a
plant outage or a planned security system outage. The proposed rule
would permit a 60-hour per person per week collective work hour limit
as an exception to the 48-hour collective work hour limit in proposed
Sec. 26.199(f). The proposed exception for security personnel would
accommodate the short-term demand for increased work hours associated
with these outages while limiting cumulative fatigue. Therefore, the
proposed requirement would provide reasonable assurance that security
personnel would remain capable of safely and competently responding to
a security incident or an increased security threat condition, should
one occur during or shortly after a period of increased work hours.
The basis for excluding work hours during the first 8 weeks of an
outage from the proposed requirement for a 48-hour group average is
discussed with respect to proposed Sec. 26.199(f)(1). However, that
exclusion would be only applicable to individuals who are performing
the duties listed in proposed Sec. 26.199(a)(1)-(a)(4) during plant
outages. During the first 8 weeks of a plant outage, those individuals
would remain subject to the proposed individual work hour controls but
their work hours would not be limited by any collective work hour
requirement. By contrast, proposed Sec. 26.199(f)(2)(i) would require
security personnel to be subject to a 60-hour per person per week
collective work hour limit, in addition to the proposed individual work
hour limits, during the first 8 weeks of a plant outage.
Proposed Sec. 26.199(f)(2)(i) also would permit licensees to
exclude security personnel from the 48-hour per person per week
collective work hour limit during the first 8 weeks of a planned
security system outage, during which time they would be subject to a
60-hour per person per week collective work hour limit. Planned
security system outages are typically of very short duration (days),
and the NRC does not expect that planned security system outages will
exceed 8 weeks in length. However, the proposed rule would establish
the 8-week limit for planned security system outages in order to
simplify implementation of the rule by applying identical exclusion
periods for all outages and increased threat conditions. Additionally,
the ability of security personnel to safely and competently perform
their duties during these varying outages and increased threat
conditions is based on the length of time individuals work additional
overtime, not on the nature of the site condition.
The proposed provision would codify, in part, requirements
established by Order EA-03-038, although it would limit the exclusion
period to 8 weeks instead of the 120-day exclusion period that is
permitted in Order EA-03-038, for the reasons discussed above. Since
September 11, 2001, the NRC has received reports of nuclear security
officers found asleep while on duty. In addition, the NRC received
numerous allegations from nuclear security officers that certain
licensees have required them to work excessive amounts of overtime over
long periods due to the post-September 11 threat environment. The
nuclear security officers questioned their readiness and ability to
perform their required job duties because of the adverse effects of
cumulative fatigue and stated that they feared reprisal if they refused
to work assigned overtime. The NRC received similar information from
newspaper articles and from interactions with public stakeholder
groups. For example, the Project on Government Oversight (POGO) issued
a report entitled, ``Nuclear Power Plant Security: Voices from Inside
the Fences,'' and submitted this report to the NRC staff (ADAMS
Accession No. ML031670987). POGO interviewed more than 20 nuclear
security officers protecting 24 nuclear reactors (at 13 plants) to
obtain material for its report. POGO reported that the security
officers who were interviewed said, ``Their plants are heavily relying
on increased overtime of the existing guard force. * * * These guards
raised serious concerns about the inability to remain alert.'' After
reviewing the work hours and FFD concerns of security personnel
subsequent to September 11, 2001, the NRC issued Order EA-03-038 to
limit the work hours of security personnel and ensure that they remain
capable of safely and competently performing their duties. The Order
required compensatory measures for limiting work hours to a collective
work hour average of 48 hours per person per week during normal
operations, as well as limiting work hours to an average of 60 hours
per week for planned plant outages and planned security system outages.
Ensuring that work schedules incorporate adequate break periods is
an important mitigation strategy for cumulative fatigue. The NRC's
initial concept for compensatory measures to prevent fatigue of
security personnel from the long work hours of outages included a
feature that required a 48-hour break in any 7-day period for periods
of elevated overtime that exceeded 45 days (ADAMS Accession No.
ML030300470). Through stakeholder interactions during development of
the Order, the NRC concluded that a 60-hour collective work hour limit
would be an effective alternative to meet the same objective and also
provided more flexibility. The proposed 60-hour limit would ensure that
security force personnel who work a 12-hour shift receive, on average,
2 days off in every 7-day period, thereby reducing the potential for
cumulative fatigue. The need for periodic long breaks was discussed
with respect to proposed Sec. 26.199(d)(2)(ii) and (d)(2)(iii).
For several reasons, control of work hours for security personnel
must be more stringent than for other individuals who would be subject
to the proposed work hour controls. First, security personnel are the
only individuals at nuclear power plants who are entrusted with the
authority to apply deadly force. Decisions regarding the use of deadly
force are not amenable to many of the work controls (e.g., peer checks,
independent verification, post-maintenance testing) that are
implemented for other personnel actions at a nuclear plant to ensure
correct and reliable performance. Second, unlike most other work
groups, security personnel are typically deployed in a configuration
such that some have very infrequent contact with other members of the
security force, or other plant personnel. A lack of social contact can
exacerbate the effects of fatigue on individuals' abilities to remain
alert (Horne, 1988). Third, these
[[Page 50601]]
deployment positions can be fixed posts where very little physical
activity is required, further promoting an atmosphere in which fatigue
could transition into sleep. Fourth, many security duties are largely
dependent on maintaining vigilance. Vigilance tasks are among the most
susceptible to degradation from fatigue (Rosekind, 1997; Monk and
Carrier, 2003). Finally, unlike operators, security forces lack
automated backup systems that can prevent or mitigate the consequences
of an error caused by fatigue.
The proposed requirement would also differ from that in Order EA-
03-038 by requiring licensees to meet 60-hour per person per week
collective work hour limit during unplanned plant outages. Order EA-03-
038 currently does not impose collective work hour limits for these
conditions. As discussed in the preceding paragraph, security duties
are particularly susceptible to fatigue. Therefore, the NRC considers
that the proposed 60-hour per person per week collective work hour
limit for security personnel should only be waived in cases in which:
(1) Licensees would be unable to sufficiently plan for the increased
security demands; and (2) the increased potential for fatigue-induced
errors is outweighed by the need for a higher complement of security
personnel on shift to maintain the common defense and security. In the
case of unplanned security system outages, although licensees would be
unable to sufficiently plan for the increased security demands that
typically accompany plant outages, the increase in those demands is
directly due to the need to return the plant to operation (such as
additional guards needed to support maintenance activities), not the
need to maintain the common defense and security (as is the case with
security system outages). The increased potential for fatigue-induced
errors under the greatly increased work hours that would be permitted
in the absence of collective work hour controls could not be justified
by the economic benefit gained by licensees.
Proposed Sec. 26.199(f)(2)(ii) would be added to establish a
collective work hour limit of 60 hours per person per week for security
personnel during the actual conduct of Force-on-Force (FOF) exercises.
The proposed rule would include a 60-hour per week collective work hour
limit for security personnel as an exception to the 48-hour collective
work hour limit in proposed Sec. 26.199(f). The proposed exception
would accommodate the short-term demand for increased work hours
associated with FOF exercises while limiting cumulative fatigue,
thereby providing reasonable assurance that security personnel will
remain capable of safely and competently responding to a security
incident or increased threat condition, should one occur during or
shortly after the conduct of FOF exercises. The basis for requiring
security personnel to be subject to a 60-hour per person per week
collective work hour limit, in addition to the individual work hour
limits, in lieu of waiving the group average limits completely, is
discussed with respect to proposed Sec. 26.199(f)(2)(i).
The proposed 60-hour collective work hour limit during FOF
exercises would be consistent with the relaxation to Order EA-03-038,
granted October 23, 2003. During public meetings concerning Order EA-
03-038, industry stakeholders commented that the FOF exercises warrant
special consideration because NRC participation in the exercises causes
some aspects of the exercises to be outside industry control, and
because of the short-term and unique staffing demands imposed on
licensees during the exercises. In addition, industry stakeholders have
commented that: (1) Hiring extra security officers for such short-term
demands would be inefficient and injurious to workforce stability; (2)
imposing a staffing level requirement on licensees sufficient to
support the FOF exercises would result in staff levels greater than
those routinely needed; and (3) the benefit of conducting these
exercises far outweighs the additional burden of the person-hours
expended. The NRC agrees that the conduct of the pilot and annual FOF
exercises warrant special consideration because: (1) The benefits of
conducting a FOF exercise outweigh concerns regarding work-hour limits;
(2) the exercises are infrequent and intensive efforts conducted over a
short-term period; and (3) the burden to meet the significant staffing
demands during the exercises would be very high if work hours were
limited to a collective average of 48 hours per person per week.
Proposed Sec. 26.199(f)(2)(iii) would be added to provide an
exception to the collective work hour limits for security personnel for
the first 8 weeks of an unplanned security system outage or an
increased threat condition. The proposed exception would codify, in
part, the compensatory measures required by Order EA-03-038. However,
Order EA-03-038 provides an exception from the collective work hour
limits in the compensatory measures for these conditions for a period
up to 120 days. Proposed Sec. 26.199(f)(2)(iii) would establish a more
stringent exception period.
Unplanned security system outages and increased threat conditions
require extensive increases in security force labor in terms of
compensatory measures. These increases can make it very difficult to
maintain work hour controls during these periods, especially because
licensees are unable to plan in advance for these circumstances.
Although the increased work hours increase the potential for cumulative
fatigue, other proposed fatigue management requirements, including the
individual work hour controls in proposed Sec. 26.199(d)(1) and
(d)(2), would provide reasonable assurance of guard readiness during
the exception period. Therefore, the benefit to plant security of
ensuring adequate staffing during such unplanned conditions would
outweigh the potential for excessive worker fatigue.
Staffing to maintain work hours within the limits of the proposed
collective work hour controls would not be practical because it would
require licensees to maintain security staffing at levels that would be
excessive for the vast majority of circumstances. Limiting periods of
extended work hours for security personnel to 8 weeks brings security
personnel closer to the requirements for the other proposed exclusion
periods, simplifying the rule and its implementation. Further, the cost
to licensees of the compensatory measures required to address security
system outages is significant, and most security systems are modular.
Therefore, an unplanned security system outage is unlikely to exceed 8
weeks. Outages of this duration have been uncommon. Therefore, reducing
the exclusion period from 120 days to 8 weeks would be unlikely to have
a practical impact on licensees.
In the case of an increased threat condition, the Department of
Homeland Security has refined their threat system to compartmentalize
increases in threat conditions for individual business sectors and
regions of the country. Also, since the inception of the system, there
has never been an increase for any period that exceeded 6 weeks. An
event that would cause NRC-regulated sites to adopt an increase over 8
weeks would likely mean a significant domestic attack had occurred. In
this event, proposed Sec. 26.199(f)(5) would provide a means for
extending the proposed 8-week exclusion period, as discussed with
respect to that provision.
Proposed Sec. 26.199(f)(2)(iv) would be added to clarify the
instances in which security personnel would be subject to a collective
work hour limit for certain instances in which multiple plant
conditions exist. As discussed with
[[Page 50602]]
respect to proposed Sec. 26.199(f)(2)(iii), licensees would not be
required to control the collective work hours of security personnel
during the first 8 weeks of an increased threat condition. Proposed
Sec. 26.199(f)(2)(iv) would establish requirements for implementing
this exception should an increased threat condition occur concurrently
with a plant outage or planned security system outage. The proposed
exception would codify, in part, an exception to group work hour
controls permitted by Order EA-03-038.
As would be required by proposed Sec. 26.199(f)(2)(i), the
collective work hours of security personnel would be limited to an
average of not more than 60 hours per person per week during any plant
outage or planned security system outage. If an increase in threat
condition occurs during such a period, and the increased threat
condition persists for a period of 8 weeks or fewer, proposed Sec.
26.199(f)(iv) would establish an exception for the collective work hour
controls on security personnel for the duration of the increased threat
condition. However, if during any such outage, the threat condition
returned to the least significant threat condition that was in effect
at any time within the past 8 weeks, then the licensee would be
required to limit the collective work hours of security personnel to an
average of 60 hours per person per week for the first 8 weeks of the
outage for the periods that occurred before and after the increased
threat condition. For example, if, during an 8-week outage, the threat
level increased at the beginning of week 3 and returned to the original
or a lower threat level at the conclusion of week 4, then the licensee
would be required to limit the collective work hours of security
personnel to a group average of no more than 60 hours per person per
week during weeks 1-2 and 5-8 of the outage. Outage weeks 3-4 would not
be subject to the proposed work hour controls because of the increased
threat condition. As such, proposed Sec. 26.199(f)(2)(iv) would
clarify the limits to be applied when multiple plant conditions occur
at the same time. Consistent with the requirements of proposed Sec.
26.199(f)(2)(i), licensees would be required to limit the collective
work hours of security personnel to an average of 48 hours per person
per week following the first 8 weeks of the outage.
This proposed exception to the collective work hour controls would
be necessary to ensure that licensees have the flexibility to take any
immediate actions necessary for maintaining plant security. The
proposed exception would be limited in duration to ensure that
licensees take appropriate long-term actions to prevent cumulative
fatigue should the increased threat condition be sustained for a period
that is longer than 8 weeks.
Proposed Sec. 26.199(f)(2)(v) would be added to further clarify
the applicability of the collective work hour limits for security
personnel during multiple consecutive and concurrent plant conditions.
Licensees would be permitted to relax collective work hour controls in
situations in which additional increases in threat condition occur
during an unplanned security system outage or increased threat
condition, but only for a period that is the shorter of either the
duration of the increased threat condition or 8 weeks. The proposed
exception would codify, in part, an exception to collective work hour
controls that is permitted by Order EA-03-038. The proposed exception
to the collective work hour controls would be necessary to ensure that
licensees have the flexibility to take any immediate actions necessary
for maintaining plant security in response to increasing security
threat levels. The proposed exception would be limited in duration to
ensure that licensees take appropriate long-term actions to prevent
cumulative fatigue should an increased threat condition be sustained
for a period of more than 8 weeks.
Proposed Sec. 26.199(f)(2)(vi) would be added to establish
requirements controlling the exception period from the collective work
hour controls when a threat condition decreases during an unplanned
security system outage or increased threat condition. In these
circumstances, the proposed rule would establish the beginning of the
exception period based upon the date upon which the current threat
condition was last entered as a result of a threat condition increase.
For example, if the threat level increases at the beginning of week 1,
increases again at the beginning of week 3, and then decreases in week
5, the beginning of the maximum 8-week exception period would be the
beginning of week 1. The proposed requirement would ensure that the
duration of the exception period is no longer than necessary based upon
the current threat level, thereby providing licensees with the
flexibility to respond to increased threat conditions while minimizing
the potential for cumulative fatigue of security personnel. Proposed
Sec. 26.199(f)(2)(vi) would codify, in part, an exception to the work
hour controls that is permitted by Order EA-03-038.
Proposed Sec. 26.199(f)(3) would be added to permit the collective
work hours of any job duty group specified in proposed Sec. 26.199(a)
to exceed an average of 48 hours per week in one averaging period if
all of the conditions specified in proposed Sec. 26.199(f)(3)(i)-
(f)(3)(iii) are met. The collective work hour controls of proposed
Sec. 26.199(f) would address the long-term control of work hours,
including the limited use of overtime for occasional, short-term,
exigent circumstances. The primary objective of proposed Sec.
26.199(f) would be to ensure that fatigue resulting from the routine
work hours of individuals performing the functions listed in proposed
Sec. 26.199(a)(1)-(a)(5) would not adversely affect their abilities to
safely and competently perform their duties, and therefore that
licensees maintain adequate shift coverage without routine heavy use of
overtime. The objective of proposed Sec. 26.199(f)(3) would be to
establish a regulatory framework that would accommodate circumstances
beyond the reasonable control of licensees, while ensuring that
licensees continue to provide reasonable assurance that the effects of
fatigue and degraded alertness on individuals' abilities to safely and
competently perform their duties are managed commensurate with
maintaining public health and safety. The criteria in proposed Sec.
26.199(f)(3)(i)-(f)(3)(iii) would permit licensees to control work
hours to a higher collective work hour limit under certain occasional,
short-term, exigent circumstances.
Proposed Sec. 26.199(f)(3)(i) would be added to establish the
first criterion for permitting a higher collective work hour limit by
requiring that the circumstances that cause collective work hours to
exceed 48 hours per person per week cannot be reasonably controlled.
Unusual circumstances (e.g., strikes, hurricanes, outage extensions for
reasons that licensees cannot reasonably control, extremely high
employee turnover) may require increased work hours for a short period
of time, and licensees cannot practically maintain staffing reserves to
avoid using overtime in such unusual circumstances. These unusual
circumstances would place licensees in jeopardy of violating the
requirements of proposed Sec. 26.199(f). However, temporarily
exceeding the proposed collective work hour limits in circumstances
that could not be reasonably controlled by a licensee generally would
not indicate that the licensee's fatigue management program was
ineffective.
Proposed Sec. 26.199(f)(3)(ii) would be added to establish the
second criterion for permitting a higher collective work hour limit in
unusual circumstances that could not be reasonably controlled. The
proposed rule would prohibit collective work hours from exceeding 54
[[Page 50603]]
hours per person per week in these circumstances. This proposed limit
would be necessary to ensure that workers do not become unacceptably
fatigued during the exigent circumstances. In some instances, licensees
may rely on this provision to permit a 54-hour per person per week
collective work hour limit during the averaging period following an 8-
week outage that was extended for reasons beyond the licensee's
reasonable control (e.g., defects in new equipment that were only
detectable following installation, late delivery of key equipment or
parts). Limiting collective work hours to 54 hours per person per week
would provide a substantial increase in the hours that would be
available to address the emergent circumstance(s) [equivalent to
approximately one month of work at the maximum hours permitted by the
individual work hour controls of proposed Sec. Sec. 26.199(d)(1) and
(d)(2)] while continuing to ensure the availability of some recovery
days.
Proposed Sec. 26.199(f)(3)(iii) would be added to establish the
third criterion for permitting a higher collective work hour limit. The
proposed rule would require that the additional work hours that result
in the group average exceeding 48 hours per person per week would be
worked only to address the circumstances that the licensee could not
have reasonably controlled. This proposed provision would require
licensees to use relief from the 48-hour collective work hour limit
only to the extent necessary, and not as an opportunity to increase
work hours for unrelated activities performed by the group. For
example, the proposed provision would permit a maintenance job duty
group's collective work hours to average 50 hours per person per week
in one averaging period if a crew of maintenance technicians worked
excess hours in order to exit an LCO on time. However, the proposed
provision would not permit the licensee to assign unrelated work
activities to other maintenance technicians, and thereby increase the
group's collective work hours to the 54 hours per person per week that
the proposed rule would permit in the specified circumstances.
Proposed Sec. 26.199(f)(4) would be added to prohibit licensees
from repeatedly permitting the collective work hours of any job duty
group to exceed an average of 48 hours per person per week. As
discussed with respect to proposed Sec. 26.199(f)(3), the NRC
recognizes that, because of circumstances that a licensee cannot
reasonably control, there may be averaging periods in which a job duty
group's collective work hours exceed the 48-hour collective limit.
However, the primary objective of the collective work hour limit would
be to prevent cumulative fatigue that can result from sustained
extended work hours. The repeated use of the accommodations afforded by
proposed Sec. 26.199(f)(3) to exceed the 48-hours per person per week
collective work hour limit in proposed Sec. 26.199(f) would be
inconsistent with the objective of preventing cumulative fatigue. Both
increased workload and decreased opportunity for rest can contribute to
cumulative fatigue (Baker, et al., 1994; Rosekind, 1997; Totterdell, et
al., 1995; Knauth and Hornberger, 2003; Rosa, 1995). With each passing
week of an extended work schedule, individuals have worked an
increasing number of their normally scheduled days off. Deferring daily
living obligations becomes increasingly difficult, causing increased
pressure to reduce sleep time in order to meet the demands of both work
and daily life, thereby increasing the potential for cumulative
fatigue. Therefore, it would be necessary to ensure that licensees do
not permit any job duty group to exceed the collective work hour limits
in the proposed rule repeatedly.
Proposed Sec. 26.199(f)(4)(i) would be added to prohibit licensees
from permitting the collective work hours of any job duty group to
exceed the 48-hour limit in any two consecutive averaging periods. This
proposed requirement would ensure that individuals in a job duty group
who worked extended hours during one averaging period have recovery
time during the subsequent averaging period, during which they would
resume working normal work hours.
Proposed Sec. 26.199(f)(4)(ii) would prohibit licensees from
permitting the collective work hours of any job duty group to exceed
the 48-hour limit in more than one averaging period during any 26-week
period. This proposed requirement would be necessary because the
proposed rule permits licensees to establish averaging periods of any
length less than 14 weeks in proposed Sec. 26.199(b)(2) [Collective
work hours]. By manipulating the lengths of averaging periods, for
example, a licensee could require a job duty group to work hours in
excess of the 48-hour collective limit during one 13-week averaging
period, reduce the group's collective work hours to 48 hours or fewer
during a subsequent 1-week averaging period, and still be in compliance
with proposed Sec. 26.199(f)(4)(ii). This schedule manipulation could
result in individuals working 48 weeks of extended work hours in a
calendar year, punctuated only by four, 1-week periods of normal work
hours, which would lead to extreme levels of cumulative fatigue.
Therefore, in order to ensure that the 48-hour collective work hour
limit achieves the objective of preventing cumulative fatigue, proposed
Sec. 26.199(f)(4)(ii) would require that any averaging periods in
which a job duty group works extended hours during normal operations
would be widely separated in time and occur no more frequently than
twice in one rolling year.
Proposed Sec. 26.199(f)(5) would be added to permit licensees to
exceed any collective work hour limit of proposed Sec. 26.199(f) if
the licensee submits a written request to the NRC and obtains advance
approval of a written request that includes the information in proposed
Sec. 26.199(f)(5)(i)-(f)(5)(iii). Proposed Sec. 26.199(f)(5) would
provide a regulatory framework for addressing unique and infrequent
circumstances, such as steam generator replacements or other extended
outages, that would be difficult to manage within the collective work
hour controls of proposed Sec. 26.199(f), but that licensees could
effectively manage using comparable work scheduling controls and
fatigue mitigation strategies. For example, an extended outage of
longer than 8 weeks may have a high workload at the beginning and end
of the outage, with limited use of extended hours in the intervening
period. The potential for cumulative fatigue may be minimal in such
circumstances. However, the use of extended work hours after the first
8 weeks of the outage would be subject to collective work hour controls
and could challenge the ability of the licensee to limit collective
work hour averages to no more than 48 hours per person per week in the
subsequent averaging period. Proposed Sec. 26.199(f)(5) would permit
licensees to obtain approval for alternative approaches to work
scheduling controls and fatigue mitigation strategies that the licensee
could tailor to these unique and infrequent circumstances.
Proposed Sec. 26.199(f)(5)(i) would be added to require that the
written request to the NRC must include a description of the specific
circumstances that would require the licensee to exceed the applicable
collective work hour limit, the job duty group(s) affected, and the
collective work hour limit(s) to be exceeded. The information regarding
the specific circumstances would be necessary for the NRC to determine
whether the circumstances warrant special consideration and whether the
[[Page 50604]]
fatigue mitigation strategies that the licensee would be required to
establish in proposed Sec. 26.199(f)(5)(iii) would be appropriate for
those circumstances. The information on the job duty group(s) affected
would be necessary for the NRC to determine whether the licensee's
proposed fatigue mitigation strategies are appropriate for those job
duty group(s) and also to ensure that NRC resident inspectors would be
aware of which job duty group(s) would be working under the revised
work hour controls, if approved. Information on the collective work
hour limit(s) to be exceeded would be necessary for the NRC to evaluate
whether the fatigue mitigation strategies would provide an effective
alternative to the limit(s) to be exceeded.
Proposed Sec. 26.199(f)(5)(ii) would be added to require the
written request to include a statement of the period of time during
which it would be necessary to exceed the collective work hour
limit(s). This information would be necessary for the NRC to evaluate
whether the fatigue mitigation strategies that the licensee would be
required to establish in proposed Sec. 26.199(f)(5)(iii) are
appropriate for the time period requested.
Proposed Sec. 26.199(f)(5)(iii) would be added to require the
written request to include a description of the fatigue mitigation
strategies, including, but not limited to, rest break requirements and
work hour limits, that the licensee would implement to ensure that the
individuals affected would be fit to safely and competently perform
their duties. This information would be necessary for the NRC to
evaluate whether these strategies would provide an effective
alternative to the work hour limits to be exceeded.
Proposed Sec. 26.199(g) [Successive plant outages] would be added
to establish requirements for the control of work hours during plant
outages that closely follow a preceding plant outage. At the conclusion
of an outage, individuals are likely to be fatigued from working
extended hours and the increased workload associated with the outage
and plant restart preparations. The objective of the proposed
requirement would be to provide adequate opportunity for individuals to
recover and transition to an operating schedule, and thereby reduce the
potential for cumulative fatigue of individuals that can result from
outages that occur in close succession. The proposed requirement would
apply to outages that follow the preceding outage by less than 2 weeks.
A minimum of 2 weeks under normal workloads and the collective work
hour requirements of proposed Sec. 26.199(f), which are generally only
applicable during non-outage periods, would be necessary to provide
reasonable assurance that individuals have the opportunity for
successive days of rest to reduce the potential for cumulative fatigue.
For purposes of work hour control, the proposed provision would require
licensees in effect, to treat outages that follow a preceding outage by
less than 2 weeks as a continuation of the first outage. Specifically,
licensees would be required to apply the requirements of proposed Sec.
26.199(d)(2)(iii), (f)(1), (f)(2)(i), and (f)(2)(iv) based upon the
number of days that have elapsed since the first plant outage in the
series began. For example, if a refueling outage lasts 6 weeks, but the
plant encounters difficulties during power ascension a day after
exiting the refueling outage, and enters a new outage, then the 8-week
exclusion period must be calculated from the beginning of the refueling
outage.
Proposed Sec. 26.199(h) [Common defense and security] would be
added to relieve a licensee from the proposed collective work hour
controls when written notification is received from the NRC for the
purpose of assuring the common defense and security for a period
defined by the NRC. This proposed paragraph would provide necessary
relief from the requirements of this proposed section in cases of
emergencies that are not otherwise covered in this section, including
war, in which the increased risk from fatigue-induced errors would be
outweighed by the need to maintain the common defense and security. The
proposed provision would define the process by which the NRC would
provide such relief.
Proposed Sec. 26.199(i) [Plant emergencies] would be added to
temporarily waive the requirements of proposed Sec. 26.199(c)-(f)
during declared emergencies, as defined in the licensee's emergency
plan. Plant emergencies are extraordinary circumstances that may be
most effectively addressed through staff augmentation that can only be
practically achieved through the use of work hours in excess of the
limits of proposed Sec. 26.199(c)-(f). The objective of the proposed
temporary exemption would be to ensure that the control of work hours
and management of worker fatigue do not impede a licensee's ability to
use whatever staff resources may be necessary to respond to a plant
emergency and ensure that the plant reaches and maintains a safe and
secure status. At the conclusion of the declared emergency, the
proposed rule would require licensees to again comply with the work
hour controls.
Proposed Sec. 26.199(j) [Reviews] would be added to require
licensees to periodically self-assess their performance with respect to
controlling the work hours of those individuals who perform the job
duties specified in proposed Sec. 26.199(a). The work hour controls in
proposed Sec. 26.199(a) would provide licensees with substantial
flexibility in controlling work hours. Accordingly, periodic self-
assessments would be necessary to maintain reasonable assurance that
the licensee is implementing the specific work hour control provisions
of proposed Sec. 26.199 consistent with the general performance
objective in proposed Sec. 26.23(e). In addition, it would be
necessary for the self-assessments to be scheduled in a manner that
would ensure timely corrective action, if necessary. Outages and
increased threat conditions increase the risk of human error as a
result of higher workload, the performance of more complex and
infrequent tasks, and the pressure to meet schedular goals. Therefore,
it would be particularly important to include those periods of time in
any assessment of the effectiveness of a licensee's work hour controls.
Proposed Sec. 26.199(j)(1) would be added to require licensees to
focus their assessments on those individuals who were at the greatest
risk of committing performance errors, including, but not limited to,
those individuals listed in proposed Sec. 26.199(j)(1)(i)-(j)(1)(iv).
These individuals would have worked the most hours when compared with
their peers during the same averaging period; have been granted the
most work-hour waivers; and were subject to fatigue assessments under
proposed Sec. 26.201 (i.e., were assessed for fatigue for cause, post-
event, or in response to a self-declaration of being unfit for duty
because of fatigue). Requiring licensees to consider individual
performance, as indicated by operating events or other errors, for
those individuals listed in proposed Sec. 26.199(j)(1)(i)-(j)(1)(iii),
would provide an indication of whether those individuals' abilities to
safely and competently perform their duties had actually been
compromised.
Proposed Sec. 26.199(j)(1)(i) would be added to require the
assessments to include individuals who were granted more than one
waiver during the review period. The proposed provision would require
licensees to assess the work hours and performance of these individuals
to ensure that licensees evaluate whether the individuals' abilities to
safely and competently perform their duties had actually been
[[Page 50605]]
compromised. The proposed requirement would be necessary to ensure that
licensees' use of waivers did not result in degraded worker fitness-
for-duty.
Proposed Sec. 26.199(j)(1)(ii) would be added to require the
assessments to include individuals who were assessed for fatigue in
accordance with Sec. 26.201 [Fatigue assessments] during the review
period. The proposed paragraph would require licensees to evaluate
whether these individuals' abilities to safely and competently perform
their duties had actually been compromised. An individual who has been
assessed for fatigue may be working above his or her tolerance for
overtime, and it would be necessary for licensees to fully evaluate the
individual's overall performance. The proposed requirement would be
necessary to ensure that licensee fatigue assessments are consistent
with worker performance and are providing an effective basis for
licensee fatigue management decisions.
Proposed Sec. 26.199(j)(1)(iii) would be added to require the
assessments to include individuals who performed the job duties listed
in proposed Sec. 26.199(a) whose average individual work hours per
week exceeded 54 hours during any averaging period for which the
collective work hours limit would be 48 hours in this proposed section.
These individuals worked significantly more hours than others in their
job duty group. The proposed requirement would be necessary to ensure
that licensees fully evaluate the work hours and performance of these
individuals, who are at a much higher risk for cumulative fatigue than
their peers. As noted with respect to proposed Sec. 26.199(j)(1)(iii),
several studies have indicated a tendency for individuals to
underestimate their levels of fatigue (Wylie, et al., 1996; Dinges,
1995; Rosekind and Schwartz, 1988). This tendency may cause an
individual to fail to recognize that his or her ability to perform is
degraded. The proposed rule would require licensees to independently
evaluate the performance of these individuals to determine whether
their abilities to safely and competently perform their duties had
actually been compromised.
Proposed Sec. 26.199(j)(1)(iv) would be added to require that the
assessments must include security personnel whose average individual
work hours per week exceeded 66 hours in any averaging periods for
which the collective work hour limit in this proposed section would be
60 hours per person per week. The proposed rule would require licensees
to evaluate the work hours and performance of these individuals for the
same reasons discussed with respect to the individuals who would be
evaluated under proposed Sec. 26.199(j)(1)(iii).
Proposed Sec. 26.199(j)(2) would be added to require licensees to
review individuals' hours worked and the waivers under which work was
performed to assess staffing adequacy for all of the jobs that are
subject to the work hour controls of proposed Sec. 26.199. The
proposed collective work hour controls of Sec. 26.199(f) would provide
assurance that licensees are managing cumulative fatigue at a gross
level for broad job duty groups, and an indication of whether staffing
is adequate to support this objective. However, the use of broad job
duty groups creates a potential that sub-groups of individuals (e.g.,
those with specialized skills) may work a disproportionate number of
hours and, consequently, may be more susceptible to fatigue than
otherwise indicated by the collective averages. Accordingly, proposed
Sec. 26.199(j)(2) would require licensees to review work hours and
waivers of the work hour controls to provide assurance that cumulative
fatigue is properly managed for all jobs.
Proposed Sec. 26.199(j)(3) would be added to require licensees to
document the methods used to conduct their reviews and the results of
the reviews. The NRC would use the documentation during site
inspections as a means of assuring compliance with the regulations. The
methods and results of the reviews would be indicative of a licensee's
performance in managing the fatigue of its workers who would be subject
to the requirements of this proposed section. Irregularities in the
review process may indicate a programmatic weakness that might trigger
further inspection activities. The NRC considers the additional
recordkeeping burden for documenting this information to be outweighed
by the NRC's need to ensure that licensees are complying with the
proposed requirements of this section and maintaining effective fatigue
management programs.
Proposed Sec. 26.199(j)(4) would be added to require licensees to
record, trend, and correct, under the licensee's corrective action
program, any problems identified in maintaining control of work hours
consistent with the specific requirements and performance objectives of
Part 26. Accordingly, licensees would be required to maintain the
documentation that would be necessary for NRC reviews of licensees'
compliance with the proposed work hour controls within the licensees'
existing corrective action programs. The proposed requirement would be
in keeping with the existing requirements in 10 CFR Part 50 Appendix B,
Criterion XVII, ``Quality Assurance Records,'' and Criterion XVI,
``Corrective Action.'' The NRC would use the documentation during site
inspections as a means of assuring compliance with the regulations. The
corrective actions and trending would be indicative of a licensee's
performance in managing the fatigue of its workers who would be subject
to the requirements of this part. Irregularities in the corrective
action process may indicate a programmatic weakness that might trigger
further inspection activities. The NRC considers the additional
recordkeeping burden for documenting this information under the
existing corrective action program to be outweighed by the NRC's need
to ensure that licensees are complying with the proposed requirements
and maintaining effective fatigue management programs.
Section 26.201 Fatigue Assessments
A new Sec. 26.201 [Fatigue Assessments] would be added to require
licensees to conduct fatigue assessments under several conditions.
These conditions, which would be specified in proposed Sec.
26.201(a)(1)-(a)(4), would include for cause, after a self-declaration,
after an event that would require post-event drug and alcohol testing,
and as a followup to returning an individual to work after a self-
declaration. The proposed assessments would be necessary to determine
whether individuals who are observed to be in a condition creating a
reasonable suspicion of impaired individual alertness or have indicated
that they are not fit for duty because of fatigue can, in fact, safely
and competently perform their duties. Further, in situations where
there has been a plant event that would require drug or alcohol testing
as specified in proposed Sec. 26.31(c), this proposed section would
require the licensee to conduct a fatigue assessment in order to
determine whether fatigue contributed to the event.
Work hour controls are necessary, but not sufficient, to
effectively manage worker fatigue. Worker fatigue, and its effects on
worker alertness and performance, can result from many causes in
addition to work hours (e.g., stress, sleep disorders, daily living
obligations) (Rosa, 1995; Presser, 2000). Further, there are
substantial individual differences in the ability to work for extended
periods without performance degradation from fatigue (Gander, 1998;
Jansen, et al., 2003; Van Dongen, et al., 2004a; Van Dongen, et al.,
2004b). The work hours controls of proposed Sec. 26.199 would provide
only partial assurance that individuals are not
[[Page 50606]]
fatigued. Therefore, fatigue assessments would be essential.
Appropriately assessing fatigue is also important because workers
who are experiencing either acute or cumulative fatigue may not be able
to perform their duties safely and competently, as discussed in Section
IV. D. There is a large body of research that demonstrates the negative
effects of fatigue on individuals' abilities to perform. The literature
includes studies comparing the effects of fatigue with those of alcohol
intoxication. The effects of both conditions can be expressed in the
form of performance decrements. Studies have correlated hours of
wakefulness with equivalent blood alcohol concentrations showing that
the performance decrements resulting from fatigue are at least as
severe as the performance decrements observed when individuals consume
the legal limit of alcohol (Dawson and Reid, 1997; Falleti, et al.,
2003). At the extreme, workers who have acute fatigue show symptoms
that are similar to those of intoxication. Speech is less precise,
attention may be lacking, and normal body movements and posture may be
absent. Therefore, it is just as important for a worker to be assessed
to determine if he or she is unduly impaired from fatigue as it is for
the worker to be evaluated to determine whether he or she is impaired
from consuming alcohol.
The objective of the assessments required by proposed Sec.
26.201(a)(1)-(a)(4) would be for licensees to appropriately address
instances of worker fatigue, including those that are not prevented by
the work hour controls, regardless of the number of hours that the
subject individual has worked or rested. As discussed with respect to
proposed Sec. 26.201(c), these assessments would provide the basis for
subsequent management actions for fatigue management (e.g., relieving
an individual of duties or requiring additional fatigue mitigation
actions). Therefore, fatigue assessments are important for effective
fatigue management because they provide the basis for any short-term
corrective actions that may be necessary to ensure that individuals are
able to safely and competently perform their duties, and any long-term
corrective actions that may be necessary to address individual or
programmatic issues contributing to recurring instances of fatigue.
Proposed Sec. 26.201(a)(1) would specify that licensees must
perform a fatigue assessment, in addition to any other testing that
would be required under proposed Sec. Sec. 26.31(c) and 26.77, if a
worker is observed to be in a condition of impaired alertness and there
is a reasonable suspicion that he or she may not be fit to safely and
competently perform his or her duties. The objective of the proposed
requirement would be to ensure that fatigue is considered, in addition
to drugs or alcohol, as a cause for impaired alertness. As noted in
SECY-01-0113, approximately 80 percent of all for-cause FFD tests
conducted annually yield negative results for drugs and alcohol. A
fatigue assessment would help to determine if fatigue was the cause for
the perceived impairment in circumstances where testing does not
support drugs or alcohol as the probable cause.
Common indications of impaired alertness include yawning, red eyes,
prolonged or excessive blinking, rubbing of the face with the hands,
and gross body movements to maintain alertness. Individuals may take
substantially longer to complete routine tasks, exhibit difficultly
processing written or oral communications, and may become less
talkative. At the extreme, workers who are experiencing acute fatigue
have symptoms that are similar to those of intoxication, as discussed
with respect to proposed Sec. 26.201. Individuals who are fatigued are
more likely to complain of illness, pain, or discomfort. In addition to
decreased vigor, fatigued individuals may be more irritable, engage in
inappropriate humor, exhibit less conservative decision-making, and
persevere in using ineffective problem solutions (Horne, 1988; Harrison
and Horne, 2000; Dinges, et al. 1997; Pilcher and Huffcutt, 1996;
Belenky, et al. 2003; Monk, 2003).
Proposed Sec. 26.201(a)(1) would not require licensees to conduct
a fatigue assessment if indications of impaired individual alertness
are observed during an individual's break period. The NRC considered a
comment from the IBEW at a September 14, 2004, public meeting
expressing concern with for-cause assessments for work performed
outside of the PA. Although whether a worker is inside the PA is not a
criterion for being subject to Part 26 requirements, the NRC recognizes
that napping is an effective means for reducing worker fatigue.
Therefore, proposed Sec. 26.201(a)(1) would exclude napping during a
break period as a condition for which the proposed provision would
require a for-cause fatigue assessment.
Proposed Sec. 26.201(a)(1) would also permit licensees to conduct
a fatigue assessment, without drug and alcohol testing, if the observed
condition is impaired alertness, with no other indication of possible
substance abuse. In developing the proposed requirement for for-cause
fatigue assessments, the NRC considered stakeholder comments during the
public meetings described in Section V. Stakeholders expressed concern
that testing for drugs and alcohol, in addition to fatigue, when the
only apparent cause of impairment was decreased alertness, would cause
stigma, burden, and reluctance to raise FFD concerns that may result in
for-cause testing. Accordingly, the proposed requirement would permit
licensees to assess only fatigue, if there are no indications of
possible substance abuse.
Proposed Sec. 26.201(a)(1) would also permit licensees to conduct
drug and alcohol testing, without a fatigue assessment, when the
licensee has reason to believe that the observed condition is not due
to fatigue. The NRC considered stakeholder comments at the public
meetings described in Section V that a requirement to perform a fatigue
assessment when the licensee has a reasonable basis for believing that
the condition is from causes other than fatigue would be an undue
burden. In many cases, an observed condition may clearly relate to
drugs or alcohol only (such as the smell of alcohol on an individual),
and in such cases there would be no benefit from requiring a fatigue
assessment.
Proposed Sec. 26.201(a)(2) would be added to require licensees to
conduct a fatigue assessment if an individual makes a self-declaration
that he or she may not be fit to safely and competently perform his or
her duties because of fatigue, except if the licensee permits or
requires the individual to take a rest break of at least 10 hours.
Self-declarations provide assurance that instances of worker fatigue,
including those that are not prevented by the work hour controls in
proposed Sec. 26.199, are appropriately addressed, regardless of the
number of hours the individual has worked or rested. Current Sec.
26.27(b)(1) requires that ``impaired workers, or those whose fitness
may be questionable, shall be removed from activities within the scope
of this part, and may be returned only after determined to be fit to
safely and competently perform activities within the scope of this
part.'' A statement by an individual to his or her supervisor that he
or she may not be fit to safely and competently perform his or her
duties because of fatigue is an indication that the individual's FFD is
questionable, and that an assessment, or a rest break of at least 10
hours, would be necessary before the individual may be returned to
duty. Therefore, in circumstances in which an individual requests to be
relieved of duties because of fatigue and the individual is relieved of
duties for at least 10 hours, the
[[Page 50607]]
proposed rule would not require the licensee to conduct another fatigue
assessment before permitting the individual to return to duty,
consistent with current industry practice. Providing a 10-hour break
would be consistent with proposed Sec. 26.199(b)(2)(i), which would
establish required break times between work periods, and is generally
considered sufficient to address most acute fatigue conditions.
As discussed with respect to proposed Sec. 26.201(c), a fatigue
assessment would provide a basis for a licensee to determine whether
the individual is able to safely and competently perform his or her
duties and what, if any, subsequent management actions for fatigue
management are necessary (e.g., relieving an individual of duties or
requiring additional fatigue mitigation actions). As discussed with
respect to proposed Sec. 6.197(b)(1)(ii), licensees would be required
to establish controls and conditions under which an individual may be
permitted or required to perform work after that individual declares
that he or she is not fit because of fatigue.
In developing the proposed requirement for fatigue assessments of
individuals who have self-declared, the NRC considered research
concerning subjective assessments of alertness. Self-declarations would
generally be based on an individual's subjective evaluation of his or
her alertness. Studies have indicated that individuals often misjudge
their own fatigue, typically by underestimating their level of fatigue
and propensity for uncontrolled sleep episodes. This effect is widely
recognized by scientists who study sleep and fatigue. Rosekind, et al.
(1997) noted that ``An important phenomenon, highly relevant to
operational environments, is that there is a discrepancy between
subjective reports of sleepiness/alertness and physiological measures.
In general, individuals will report higher levels of alertness than
indicated by physiological measures.'' As a consequence, individuals
who self-declare would tend to be more impaired than they realize. An
exception to this tendency has been noted by Dinges, et al. (1988), who
noted that naps can benefit the performance of those experiencing sleep
loss, without that benefit being apparent in subjective measures.
Therefore, it is not only important to assess self-declarations as an
indicator that an individual may not be able to safely and competently
perform his or her duties, but also to consider factors in addition to
a self-declaration as part of the fatigue assessment.
Proposed Sec. 26.201(a)(2) would also specify that licensees must
perform fatigue assessments for self-declarations made to an
individual's supervisor. The NRC considered stakeholder comments at
public meetings that the proposed requirement should be clear with
respect to the behavior that constitutes a self-declaration. For
example, stakeholders expressed concern that an individual's off-hand
remark to a co-worker that he or she is groggy would be considered a
self-declaration under the proposed rule and, therefore, require a
fatigue assessment in conditions that could be satisfactorily addressed
through less formal processes. The NRC's objective is not to supplant
these normal processes for licensee workforce management, but to ensure
that formal declarations of fatigue are appropriately evaluated and
addressed. Therefore, the proposed requirement would specify that
fatigue assessments must be conducted for self-declarations concerning
an individual's ability to ``safely and competently perform his or her
duties'' and require that the self-declaration must be made to the
individual's supervisor. However, as discussed with respect to proposed
Sec. 26.201(a)(1), a fatigue assessment must be performed in response
to an observed condition of impaired alertness. If, in the preceding
example, the ``groggy'' individual remains on duty and is observed to
exhibit impaired alertness, a fatigue assessment would be required
``for-cause'' in accordance with proposed Sec. 26.201(a)(1).
Proposed Sec. 26.201(a)(3) would be added to specify that
licensees must perform a fatigue assessment after an event that would
require drug or alcohol testing, as required in proposed Sec.
26.31(c)(3). Proposed Sec. 26.31(c)(3)(i)-(c)(3)(iii) would specify
the events and conditions requiring post-event drug and alcohol
testing. A fatigue assessment would also be necessary in these
circumstances to determine whether worker fatigue contributed to the
event and, if so, to identify the need for any corrective actions to
prevent similar future events. The assessment would also provide the
basis for subsequent management actions for fatigue management, as
required by proposed Sec. 26.201(c) (e.g., relieving an individual of
duties or requiring additional fatigue mitigation actions). Further,
the fatigue assessment may provide insights concerning the
effectiveness of the licensee's fatigue management program.
Consistent with proposed Sec. 26.31(d)(5)(ii), the proposed
requirement would specify that licensees may not delay necessary
medical treatment in order to conduct a fatigue assessment, if the
event involved physical harm to the individual. The NRC considers the
immediate medical needs of the individual to be paramount. In these
circumstances, it is reasonable to presume that the individual has been
removed from duty and consequently the individual's level of fatigue
would be irrelevant to the immediate protection of public health and
safety or the common defense and security.
Proposed Sec. 26.201(a)(4) would be added to require licensees to
perform a followup fatigue assessment if an individual is to be
returned to work after a break of fewer than 10 hours following a
fatigue assessment that was performed for cause or in response to a
self-declaration. Although sleep periods of less than 8 hours (e.g.,
naps) can mitigate some effects of fatigue, such sleep periods are
typically insufficient to provide complete recovery from fatigue
(McCallum, et al., 2003; Dinges, et al 1997; Totterdell, et al., 1995).
As a consequence, the objective of this proposed provision would be to
ensure that, in circumstances of sleep periods of less than 8 hours
(e.g., if a licensee provides an individual an opportunity for a nap
rather than a 10-hour break), the short rest break has provided
sufficient rest to mitigate the individual's fatigue, and that the
individual is not still groggy from sleep inertia. Sleep inertia is the
grogginess that an individual experiences in the transition from sleep
to wakefulness that can temporarily affect an individual's ability to
safely and competently perform his or her duties (Bruck and Pisani,
1999; Sallinen, et al., 1998). Further, the assessment would ensure
that the individual is capable of performing his or her duties safely
and competently during the upcoming work period. It would also provide
the information necessary for the licensee to determine whether any
controls or conditions must be implemented during the work period
(Priest, 2000; Baker, et al., 1990; Sallinen, 1998; Kruger, 2002).
Proposed Sec. 26.201(b) would be added to require that either a
supervisor or a staff member of the FFD program, who is trained in
accordance with the requirements of proposed Sec. Sec. 26.29 and
26.197(c), must conduct any fatigue assessment that would be required
under proposed Sec. 26.201. In accordance with proposed Sec.
26.201(c), fatigue assessments would provide the basis for subsequent
actions for fatigue management (e.g., relieving an individual of duties
or requiring
[[Page 50608]]
additional fatigue mitigation actions). In addition, the NRC recognizes
that fatigue assessments may be used by some licensees as a basis for
imposing sanctions on individuals. Therefore, the authority to perform
fatigue assessments should be limited to supervisors or staff members
of the FFD program. The training required by Sec. Sec. 26.29 and
26.197(c) would provide the knowledge and abilities that are essential
to a supervisor's or FFD program staff member's ability to make valid
assessments in this regard. Among other FFD topics, the proposed
training would address: (1) The contributors to worker fatigue and
decreased alertness in the workplace; (2) symptoms of worker fatigue;
(3) indications and risk factors for common sleep disorders; and (4)
the effective use of fatigue countermeasures. Individuals would also be
required by proposed Sec. 26.29(b) to demonstrate successful
completion of the training by passing a comprehensive examination that
addresses the KAs.
Proposed Sec. 26.201(b) would further require that supervisors or
FFD program staff members must perform the fatigue assessment face to
face with the subject individual. This proposed requirement would
ensure that the individual performing the assessment has the
opportunity to (1) observe the subject individual's appearance and
behavior to note indications of fatigue (e.g., decreased facial tone,
rubbing of eyes, slowed speech); (2) interact with the individual to
understand the individual's self-assessment of his or her ability to
safely and competently perform his or her duties; and (3) understand
any factors in addition to the individual's work schedule that may have
contributed to fatigue.
Proposed Sec. 26.201(b)(1) would be added to prohibit individuals
who observe another individual who is exhibiting indications of
impaired alertness from performing the for-cause fatigue assessment of
that individual. Without this proposed prohibition, a single supervisor
could potentially both observe a worker exhibiting indications of
impairment from fatigue and also conduct the for-cause assessment of
that worker. In accordance with proposed Sec. 26.201(c), fatigue
assessments would provide the basis for subsequent management actions
for fatigue management. In addition, some licensees may use fatigue
assessments as a basis for imposing sanctions on individuals, if, for
example, a licensee believes that an individual has been negligent in
maintaining his or her FFD. Therefore, in the case of fatigue
assessments that would be conducted for cause, the fatigue assessment
should be performed by an independent third party to provide reasonable
assurance of an objective assessment.
Proposed Sec. 26.201(b)(2) would be added to prohibit individuals
from performing a post-event fatigue assessment in those circumstances
specified in proposed Sec. 26.201(b)(2)(i)-(b)(2)(iii), in which a
conflict of interest may be present. An individual who has a conflict
of interest may not provide an objective assessment of the subject
individual's fatigue. The proposed requirement would provide assurance
of an objective fatigue assessment by prohibiting individuals from
performing the assessment who were directly responsible for performing
the work or assessing the individuals who were involved in the event.
Proposed Sec. 26.201(b)(2)(i) would be added to prohibit
individuals from performing a post-event fatigue assessment if they
performed or directed the work activities during which the event
occurred. A supervisor who performed some of the work activities during
which the event occurred may benefit from either positive or negative
results from a fatigue assessment of another individual, depending on
the circumstances. Similarly, a supervisor who directed the work
activities of an individual may avoid an adverse action against himself
or herself for the actions of a fatigued individual under his or her
supervision if the supervisor erroneously assessed the individual as
not fatigued. Therefore, the proposed rule would prohibit these
individuals from performing fatigue assessments under the specified
conditions.
Proposed Sec. 26.201(b)(2)(ii) would be added to prohibit
individuals from performing a post-event fatigue assessment if they
performed, within 24 hours before the event occurred, a fatigue
assessment of the individuals who were performing or directing the work
activities during which the event occurred. These individuals may have
a conflict of interest. For example, if an individual had previously
self-declared fatigue, but a fatigue assessment determined he or she
was fit to continue work, and an event subsequently occurred that would
require the subject individual to be assessed again, then the
supervisor who performed the first assessment may avoid adverse action
for their previous determination by performing the post-event fatigue
assessment and erroneously determining the individual was not fatigued.
Therefore, the proposed rule would prohibit these individuals from
performing fatigue assessments under the specified conditions.
Proposed Sec. 26.201(b)(2)(iii) would be added to prohibit
individuals from performing a post-event fatigue assessment if they
evaluated or approved a waiver of the limits specified in proposed
Sec. 26.199(d)(1) and (d)(2) for any of the individuals who were
performing or directing the work activities during which the event
occurred, if the event occurred while such individuals were performing
work under that waiver. For example, a supervisor who previously
assessed an individual such that the individual would be permitted to
perform work under a waiver would benefit from an assessment that the
individual was not fatigued if an event occurred while the individual
was working under the waiver. Therefore, the proposed rule would
prohibit these individuals from performing fatigue assessments under
the specified conditions.
Proposed Sec. 26.201(c) would be added to require that fatigue
assessments must provide the information necessary for management
decisions and actions in response to the circumstance that initiated
the assessment. This information would be necessary to determine the
subject individual's ability to safely and competently perform his or
her duties, as well as any controls or conditions that must be
implemented. Proposed Sec. 26.201(c) would provide assurance that
fatigue assessments include sufficient and appropriate information to
support a valid assessment of the individual relative to fatigue and
therefore an appropriate basis for management decisions and actions.
The criteria listed in proposed Sec. 26.201(c)(1)(i)-(c)(1)(iii) would
specify the minimum considerations for fatigue assessments.
In determining the scope of the proposed assessments, the NRC
considered the need for licensees to be able to focus the assessment on
information that would be readily available and verifiable. Proposed
Sec. 26.201(c) would require the assessment to address the three work
schedule factors that are generally considered to be the largest
determinants of worker fatigue (Akerstedt, 2003, 2004; McCallum, et
al., 2003; Mallis, et al., 2002; Folkard and Monk, 1980; Rosa, 1995;
Rosa, et al., 1996), as follows:
Proposed Sec. 26.201(c)(1)(i) would be added to specify the first
criterion that fatigue assessments would address, which is acute
fatigue. Acute fatigue directly affects an individual's ability to
safely and competently perform his or her duties, as discussed in
Section IV. D. Licensees could assess the potential for acute fatigue
by estimating, at a
[[Page 50609]]
minimum, the total number of continuous hours the individual has been
awake, as well as considering other individual factors or information
provided by the individual (such as his or her ability to obtain rest
during break periods).
Proposed Sec. 26.201(c)(1)(ii) would be added to specify the
second criterion that fatigue assessments would address, which is
cumulative fatigue. Cumulative fatigue also directly affects an
individual's ability to safely and competently perform his or her
duties, as discussed in Section IV. D. Licensees could assess the
potential for cumulative fatigue by reviewing, at a minimum: (1) The
individual's work schedule during the past 14 days to assess whether
the individual had adequate opportunity to obtain sufficient rest,
considering the length and sequencing of break periods; (2) whether the
available sleep periods occurred during the night or at other times
when sleep quality may be degraded; (3) the potential for transitions
between shifts (e.g., from days to nights) to have interfered with the
ability of the individual to obtain adequate rest; as well as (4) other
individual factors or information provided by the individual (such as
any personal issues that impact his or her ability to obtain adequate
sleep). For cumulative fatigue, the sleep medicine scientific
establishment uses the concept of a ``sleep debt,'' which is analogous
to a bank account becoming overdrawn, and is a measure of how much an
individual's sleep is being cumulatively reduced from his or her
everyday sleep need. Many individuals build up a slight sleep debt
during the working week, dissipating it by ``catch-up'' sleep on
weekends (National Sleep Foundation, 2000; Monk, et al., 2001).
Therefore, in evaluating cumulative fatigue, how much of a ``sleep
debt'' the worker had accrued in the preceding week needs to be
evaluated. Dinges and colleagues (1997) noted a five-to seven-fold
increase in the percentage of subjects noting a significant ``illness,
infection, pain, discomfort, worry or problem'' in their daily logs as
they progressed from baseline through the seven nights of restricted
sleep. In addition to the expected decrements in vigor over the
restricted sleep days, subjects' ratings indicated increases in
confusion-bewilderment, tension-anxiety, and total mood disturbance.
Symptoms of cumulative fatigue are in some ways similar to those of
acute fatigue, but in other ways quite different. The term,
``burnout,'' has been used to describe workers experiencing cumulative
fatigue. Similar to burnout from other sources, burnout from cumulative
fatigue is often characterized by a lack of initiative and/or
creativity, with the individual just ``going through the motions like a
zombie'' without being actively engaged or involved in the job he or
she is being asked to perform. Harrison and Horne (2000) advanced the
view that the more creative thought processes are those most likely to
be impaired by the individual receiving insufficient amounts of the
``core'' sleep needed for cognitive restitution. They note ``[sleep
deprivation] presents particular difficulties for decision-making
involving the unexpected, innovation, revising plans, competing
distraction and effective communication.''
Proposed Sec. 26.201(c)(1)(iii) would be added to specify the
third criterion that fatigue assessments would be required to address,
which is circadian variations in alertness and performance. The impact
of such variations on an individual's ability to safely and competently
perform his or her duties is discussed in Section IV. D. Licensees
could assess the potential for circadian degradations in alertness and
performance by considering the time of day or night during which the
work was or would be performed and whether the time period coincides
with a circadian trough in the individual's level of alertness.
Proposed Sec. 26.201(c)(2) would be added to require that
individuals must provide complete and accurate information that may be
required by the licensee to address the factors listed in proposed
Sec. 26.20(c)(1) (i.e., acute fatigue, cumulative fatigue, and
circadian variations in alertness and performance). Although work hours
are an important determinant of worker fatigue, there are many other
factors that can affect worker fatigue, not all of which may be readily
apparent to a licensee. As a consequence, effective assessment and
management of fatigue is a shared responsibility of individuals and
licensees, and depends upon complete and accurate communication between
the individual and the licensee concerning matters that may influence
an individual's level of fatigue. For example, licensees may be able to
estimate the total number of continuous hours that an individual has
been awake through review of the individual's work schedule and
assumptions regarding typical waking times for individuals on that
schedule. However, individuals can provide information to better
approximate the number of hours they have been continuously awake and
facilitate a more accurate assessment of acute fatigue. Additionally,
individuals may be able to provide information about their general
level of work and non-work-related activities, and opportunities for
rest during the period addressed in the fatigue assessment.
Licensees can practically assess the potential for cumulative
fatigue by reviewing the individual's work schedule during the past 14
days to identify schedule features that typically influence whether an
individual has had adequate opportunity to obtain sufficient rest.
However, there are substantial individual differences in the ability to
adapt to various schedules (Monk and Folkard, 1985). Therefore,
individuals can provide general information related to the quality and
quantity of sleep that they actually obtained during this period, which
would substantively improve the licensee's assessment of the potential
for cumulative fatigue.
Licensees can practically assess the potential for circadian
degradations in alertness and performance by considering the time of
day or night during which the work has been or would be performed and
whether the time period would coincide with a circadian trough in
alertness for the individual. However, individuals differ in the extent
and rate at which they adapt to work during periods in which they would
otherwise be asleep (Folkard and Tucker, 2003; Carrier and Monk, 2000)
and can provide information (e.g., the timing of their sleep periods)
that can better inform a licensee's assessment of the potential for
circadian degradations in alertness.
Proposed Sec. 26.201(c)(2) would also limit licensees' inquiries
to obtaining from the subject individual only the information that is
necessary to assess the factors listed in proposed Sec. 26.201(c)(1).
The fatigue assessment should provide a valid basis for licensee
decisions and actions for fatigue management without undue invasion of
an individual's privacy. For example, inquiries limited to the amount,
quality, and timing of sleep, and general activity level of the
individual can support an accurate fatigue assessment without the need
for an individual to divulge personal details about the reasons for
missed sleep or abnormal timings for sleep. Consistent with proposed
Sec. 26.37 [Protection of information], licensees would be required to
keep any information from the individual's self-disclosures
confidential.
Proposed Sec. 26.201(d) would be added to prohibit licensees from
concluding that fatigue had not or will not degrade the individual's
ability to safely and competently perform his or her duties solely on
the basis that the individual's
[[Page 50610]]
work hours have not exceeded any of the limits specified in proposed
Sec. 26.199(d)(1) or that the individual has had the minimum rest
breaks required in proposed Sec. 26.199(d)(2). The individual work
hour controls of proposed Sec. 26.199(d)(1) and (d)(2) would be
intended to provide reasonable measures to prevent fatigue due to
excessive work hours. However, the proposed controls address only work
hours and the length of rest breaks, and as a consequence, compliance
with these controls may not prevent an individual from experiencing
fatigue from one or more of the many other factors that can cause
fatigue, some of which may not be readily apparent to an employer.
Workload and the type of work an individual performs, home stresses,
sleep disorders, and differences in an individual's ability to work
extended hours or adapt to certain schedules can all substantively
affect worker fatigue (Rosa, 1995; Totterdell, et al., 1995; Knauth and
Hornberger, 2003). Although the NRC considered the findings from
studies of work hours and worker fatigue in developing the proposed
maximum work hours and minimum rest requirements of proposed Sec.
26.199(d)(1) and (d)(2), it is neither practical nor possible to
establish limits that would prevent fatigue for all individuals.
Therefore, the proposed rule would require licensees to consider
factors in addition to work hours and rest breaks when determining
whether an individual is fit to safely and competently perform duties.
Proposed Sec. 26.201(e) would be added to require that, following
a fatigue assessment, the licensee must decide whether the individual
may perform job duties without a rest break, and, if so, whether
controls and conditions must be established under which the individual
may perform those duties. Controls and conditions may be necessary to
ensure that the duties are performed in a safe and competent manner.
Examples of controls and conditions would include, but would not be
limited to: (1) A rest break; (2) peer review and approval of assigned
job tasks; (2) assignment of job tasks that are non-repetitive in
nature; (3) assignment of job tasks that are simple in nature; and (4)
assignment to job duties that are not important to the protection of
public health and safety or common defense and security. Proposed Sec.
26.201(e) would also require licensees to ensure that any controls and
conditions that have been determined to be necessary to return an
individual to duty would be implemented.
Proposed Sec. 26.201(f) would be added to require that licensees
must document the results of any fatigue assessments that are
performed, the circumstances that necessitated the fatigue assessments,
and any controls and conditions that were implemented. The proposed
documentation would be necessary for NRC inspectors to evaluate the
fatigue assessment component of licensees' FFD programs and for the
licensee to conduct the reviews required under proposed Sec. 26.199(j)
[Reviews]. The information that the proposed rule would require
licensees to document would provide indicators of how well a licensee's
fatigue mitigation program at a site is performing.
Subpart J--Recordkeeping and Reporting Requirements
Section 26.211 General Provisions
Proposed Sec. 26.211 [General provisions] would be added to define
general requirements related to recordkeeping and reporting under Part
26.
Proposed Sec. 26.211(a) would establish a requirement that
licensees and other entities who are subject to this part must maintain
records and submit certain reports to the NRC, consistent with Goal 6
of this rulemaking, which is to improve clarity in the organization and
language of the rule. In addition, the proposed paragraph would require
that licensees and other entities retain the records required under the
proposed rule for either the periods that are specified in proposed
Subpart J or for the life of the facility's license, certificate, or
other regulatory approval, if no records retention requirement is
specified. This general records retention requirement is a standard
administrative provision that is used in all other parts of 10 CFR that
contain substantive requirements applicable to licensees and
applicants, such as 10 CFR 50.71(c), and would be added for clarity in
the language of the rule.
Proposed Sec. 26.211(b) would be added to permit records to be
stored and archived electronically if the method used to create the
electronic records: (1) Provides an accurate representation of the
original records; (2) prevents the alteration of any archived
information and/or data once it has been committed to storage; and (3)
allows easy retrieval and re-creation of the original records. The
proposed paragraph would be added to recognize that most records are
now stored electronically and must be protected to ensure the integrity
of the data. The proposed requirements would be consistent with related
requirements in the access authorization orders issued to nuclear power
plant licensees dated January 7, 2003, and would, therefore, meet Goal
4 of this rulemaking, which is to improve consistency between FFD
requirements and access authorization requirements established in 10
CFR 73.56, as supplemented by orders to nuclear power plant licensees
dated January 7, 2003.
Section 26.213 Recordkeeping Requirements for Licensees and Other
Entities
Proposed Sec. 26.213 [Recordkeeping requirements for licensees and
other entities] would amend current Sec. 26.71 [Recordkeeping
requirements]. Current Sec. 26.71(d), which establishes requirements
for FFD program performance reports, would be retained in a separate
section that would focus only on those reports in proposed Sec. 26.217
[Fitness-for-duty program performance data]. Proposed Sec. 26.213
would retain but amend current Sec. 26.71(a)-(c) and add other
requirements that are interspersed throughout the current rule. These
proposed changes would be made to meet Goal 6 of this rulemaking, which
is to improve clarity in the organization and language of the rule, by
grouping recordkeeping requirements that apply to licensees and other
entities in one section.
Proposed Sec. 26.213(a) would require licensees and other entities
to retain certain records related to authorization decision-making for
at least 5 years after an individual's authorization has been
terminated or denied, or until the completion of all related legal
proceedings, whichever is later. The proposed requirement to retain
records until the completion of all related legal proceedings would be
added at the suggestion of stakeholders during the public meetings
discussed in Section V. The stakeholders noted that some legal
proceedings involving records of the type specified in the proposed
paragraph have continued longer than the 5 years that the current rule
requires these records to be retained and that adding a requirement to
retain the records until all legal proceedings are complete would
protect individuals' right to due process under the rule. The proposed
change would be consistent with Goal 7 of this rulemaking, which is to
protect the privacy and due process rights of individuals who are
subject to Part 26.
Proposed Sec. 26.213(a)(1) would amend current Sec. 26.71(a),
which requires licensees to retain records of the inquiries that
licensees conduct in granting unescorted access to an individual for 5
years following the termination of such access authorizations. The
proposed paragraph
[[Page 50611]]
would update the terminology used in the current paragraph for
consistency with the revised language used throughout the proposed
rule. For example, the proposed paragraph would refer to ``self-
disclosures,'' ``employment histories,'' ``suitable inquiries,'' and
``granting authorization,'' but retain the intent of the current
paragraph. The proposed changes in terminology would be made for the
reasons discussed with respect to proposed Sec. Sec. 26.61 [Self-
disclosure and employment history] and 26.63 [Suitable inquiry]. In
addition, the current cross-reference to Sec. 26.27(a) would be
updated to cross-reference the related portions of the proposed rule.
Proposed Sec. 26.213(a)(2) would amend current Sec. 26.71(b),
which requires licensees to retain records that are related to
confirmed positive test results that have been confirmed by the MRO.
The proposed paragraph would revise the current requirement by
requiring licensees and other entities to retain records that are
related to any violation of the FFD policy, which would include
confirmed positive drug and alcohol test results. This proposed change
would be made to ensure that licensees and other entities who may be
considering granting authorization to an individual who has previously
violated any aspect of an FFD policy can obtain these records for
review as part of the authorization decision-making process specified
in proposed Sec. 26.69 [Authorization with potentially disqualifying
fitness-for-duty information].
Proposed Sec. 26.213(a)(3) would be added to require licensees and
other entities to retain records that are related to the granting and
termination of an individual's authorization. The proposed paragraph
would be necessary to ensure that licensees and other entities who may
be considering granting authorization to an individual under proposed
Subpart C [Granting and Maintaining Authorization] can determine which
category of authorization requirements in proposed Subpart C would
apply to the individual, based upon the length of time that has elapsed
since the individual's last period of authorization was terminated and
whether the individual's last period of authorization was terminated
favorably. The proposed categories of authorization requirements are
discussed in Section IV. C and in this section, with respect to
proposed Subpart C.
Proposed Sec. 26.213(a)(4) would be added to require licensees and
other entities to retain records that are related to any determination
of fitness that was conducted under proposed Sec. 26.189
[Determination of fitness]. The proposed requirement would be necessary
to ensure that licensees and other entities who may be considering
granting authorization to an individual who has previously undergone a
determination of fitness can obtain these records for review as part of
the authorization decision making process specified in proposed Sec.
26.69 [Authorization with potentially disqualifying fitness-for-duty
information]. In addition, if an individual who is subject to a
followup testing and treatment plan transfers to another FFD program,
the reviewing official and SAE of the receiving FFD program, which
would take responsibility for implementing the testing and treatment
plans, would require access to this information.
Proposed Sec. 26.213(b)(1) and (b)(2) would require licensees and
other entities to retain records related to FFD training, examinations,
audits, audit findings, and corrective actions for at least 3 years, or
until the completion of all related legal proceedings, whichever is
later. The proposed paragraphs would retain the 3-year recordkeeping
requirements of the current rule in Sec. Sec. 26.21(b) and 26.22(c)
for training records, and Sec. 26.80(c) for audit findings and
corrective action records.
Proposed Sec. 26.213(c) would amend current Sec. 26.71(c), which
requires licensees to retain records related to any individual who was
made ineligible for authorization for 3 years or longer under current
Sec. 26.27 [Management actions and sanctions to be imposed] until the
Commission terminates each license under which the records were
created. The proposed paragraph would require licensees and other
entities to retain records concerning 5-year and permanent denials of
authorization for 40 years or until, upon application, the NRC
determines that the records are no longer needed. The proposed
paragraph would add the requirement to retain records related to 5-year
denials of authorization for consistency with the more stringent
sanctions established in proposed Sec. 26.75(c), (d), and (e)(2), in
which the sanction of a 3-year denial of authorization has been
eliminated, as discussed with respect to those proposed paragraphs. The
40-year retention requirement would be based on the longest expected
working life of an individual, rather than on the period of the
license. The termination of a license by the Commission would not mean
that the individuals whose authorization was denied for 5 years or
permanently denied under the licensee's FFD program would necessarily
leave the industry. Requiring retention of the records pertaining to
those individuals would ensure that the records of the 5-year and
permanent denials are available, should the individual seek
authorization from another licensee or other entity.
Proposed Sec. 26.213(d) would replace the recordkeeping
requirement in current Sec. 26.20 [Written policy and procedures]. The
proposed paragraph would require licensees and other entities to retain
superseded FFD policies and procedures for at least 5 years or until
they would no longer be needed to respond to a legal challenge. The
period of time that superseded materials would be retained would be
increased from 3 to 5 years to ensure that the materials are available
if subsequent licensees and other entities require the information in
making a determination of fitness. The proposed requirement to retain
the policy and procedures related to any matter under legal challenge
until the matter is resolved would be added to ensure that the
materials remain available, should an individual, the NRC, a licensee,
or another entity who is subject to this rule require access to them in
a legal or regulatory proceeding.
Proposed Sec. 26.213(e) would amend the requirement in current
Sec. 26.23(a) pertaining to the retention of written agreements for
the provision of FFD program services. The proposed paragraph would
require licensees and other entities to retain the written agreement
for the life of the agreement (as in the current rule) or until
completion of all legal proceedings related to an FFD violation that
involved the services, whichever is later. The proposed requirement to
retain the written agreements for any matter under legal challenge
until the matter is resolved would be added to ensure that the
materials remain available, should an individual, the NRC, a licensee,
or another entity who would be subject to the rule require access to
them in a legal or regulatory proceeding.
Proposed Sec. 26.213(f) would be added to require licensees and
other entities to retain records related to the background
investigations, credit and criminal history checks, and psychological
assessments of FFD program personnel, conducted under proposed Sec.
26.31(b)(1)(ii), for the length of the individual's employment by or
contractual relationship with the licensee or other entity, or until
the completion of all related legal proceedings, whichever is later.
The proposed paragraph would be consistent with the last phrase of
current Section 2.6(c) in Appendix A to Part 26, which requires
licensee testing facilities to
[[Page 50612]]
retain personnel files that include ``appropriate data to support
determinations of honesty and integrity conducted in accordance with
Section 2.3 of this appendix.'' The proposed period during which these
records must be maintained would be based on the NRC's need to have
access to the records for inspection purposes and the potential need
for the records to remain available should an individual, the NRC, a
licensee, or another entity who would be subject to this rule require
access to them in a legal or regulatory proceeding. However, the
proposed rule would establish a new limit on the period during which
the records must be retained in order to reduce the burden associated
with storing such records indefinitely.
Proposed Sec. 26.213(g) would be added to require licensees and
other entities to retain records of the certification of the scientific
and technical suitability of any assays and cutoff levels used for drug
testing that are not addressed in this part, provided by a qualified
forensic toxicologist, as required under proposed Sec. 26.31(d)(1)(i)
and (d)(3)(iii)(C). The proposed paragraph would require the licensee
or other entity to retain these records for the period of time during
which the FFD program continues to test for drugs for which testing is
not required under this part, uses more stringent cutoff levels than
those specified in this part, or until the completion of all related
legal proceedings, whichever is later. This proposed requirement would
be necessary to ensure the NRC's access to the records for inspection
purposes and that the records remain available should an individual,
the NRC, a licensee, or another entity who would be subject to this
rule require access to them in a legal or regulatory proceeding.
Section 26.215 Recordkeeping Requirements for Collection Sites,
Licensee Testing Facilities, and Laboratories Certified by the
Department of Health and Human Services
A new Sec. 26.215 [Recordkeeping requirements for collection
sites, licensee testing facilities, and laboratories certified by the
Department of Health and Human Services] would be added to group
together in one section the recordkeeping requirements that apply to
collection sites, licensee testing facilities, and HHS-certified
laboratories contained in current Sec. Sec. 26.20 and 26.71, and,
Sections 2.5(f), 2.6 (c), 2.7(a)(1), 2.7(f)(2), 2.7(g)(8), 2.7(n),
2.7(o)(1) and (o)(3), 2.8(e)(4), 2.9(g), and 3.1 in Appendix A to Part
26. The proposed rule would group these requirements in one section to
make them easier to locate within the proposed rule, consistent with
Goal 6 of this rulemaking, which is to improve clarity in the
organization and language of the rule.
Proposed Sec. 26.215(a) would retain the requirement in current
Section 2.7(n) in Appendix A to Part 26, which mandates that HHS-
certified laboratories and licensee testing facilities must maintain
documentation of all aspects of the testing process for at least 2
years, and would extend this requirement to collection sites. The
proposed rule would include collection sites within this provision
because licensee testing facilities and collection sites may not be co-
located, as was typically the case when the current rule was first
published. The proposed paragraph would retain the provision in current
Section 2.7(n) that the 2-year period may be extended upon written
notification by the NRC or any licensee or other entity for whom
services are being provided. The proposed rule would also add a
requirement to retain the documentation until completion of all legal
proceedings related to an FFD violation to ensure that the records
remain available should an individual, the NRC, a licensee, or another
entity who would be subject to this rule require access to them in a
legal or regulatory proceeding.
Proposed Sec. 26.215(b)(1)-(b)(14) would be added to list in a
single paragraph the documents that must be retained by collection
sites, licensee testing facilities, and HHS-certified laboratories.
Specifically, those documents would include personnel files of
individuals who are no longer working at a collection site, licensee
testing facility or HHS-certified laboratory, chain-of-custody
documents, quality assurance/quality control records, superseded
procedures, all test data, test reports, records on performance
testing, records on testing errors or unsatisfactory performance and
the investigation and correction of the errors or unsatisfactory
performance, performance records on certification inspections, records
on preventative maintenance, records on negative test results based on
scientific insufficiency, computer-generated data, printed or
electronic copies of computer-generated data, records of individuals
accessing secured areas in licensee testing facilities and HHS-
certified laboratories, and records of EBT maintenance, inspection, and
calibration. This listing of records to be retained comes from
provisions of the current rule in Sec. 26.20 and Sec. 26.71(a); and
in Appendix A to Part 26, Sections 2.7(a)(1), 2.7(f)(2), 2.7(g)(8),
2.7(n), 2.7(o)(1), 2.7(o)(3), 2.8(e)(4), 2.9(g), and 3.1. The proposed
rule would group them together in a single paragraph to make them
easier to locate within the rule, consistent with Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule.
Section 26.217 Fitness-for-Duty Program Performance Data
A new Sec. 26.217 [Fitness-for-duty program performance data]
would amend the requirements in current Sec. 26.71(d) for collecting,
compiling, and submitting FFD program performance data to reduce the
burden on licensees and other entities and to make the reporting time
consistent with the NRC's need for the information. Specifically, the
proposed rule would require licensees and other entities to submit
program performance data to the NRC every 12 months, rather than every
6 months. The proposed rule would make additional conforming changes to
current Sec. 26.71 for consistency with other revisions to the rule,
as follows:
Proposed Sec. 26.217(a) would retain the requirement in current
Sec. 26.71(d) that each FFD program subject to Part 26 must collect
and compile FFD performance data.
Proposed Sec. 26.217(b)(1)-(b)(8) would amend the second sentence
of current Sec. 26.71(d) to specify the FFD program performance data
that a licensee or other entity must report, including the random
testing rate, the drugs for which is conducted and cutoff levels,
workforce populations tested, numbers of tests administered and
results, conditions under which the tests were performed, substances
identified, number of subversion attempts by type, and summary of
management actions. The proposed paragraph is identical to the
requirements of the current provision with two exceptions: (1) The
current rule does not require reporting the number of subversion
attempts by type and (2) the proposed rule would not require a list of
events reported during the reporting period.
The proposed rule would add a requirement for licensees and other
entities to report the number of subversion attempts by type. This
proposed reporting requirement would be necessary to enable the NRC to
monitor the ongoing integrity and effectiveness of FFD programs in
detecting subversion attempts, consistent with the NRC's heightened
concern with this issue, as discussed with respect to proposed
Sec. Sec. 26.31(d)(3)(i) and 26.75(b). Although this information would
be available to NRC inspection personnel at each site,
[[Page 50613]]
it would be costly and an inefficient use of inspection resources for
inspectors to aggregate and report it annually. Under the current rule,
licensees typically report subversion attempts they have detected under
the requirement to summarize ``events reported'' in current Sec.
26.71(d). Therefore, the NRC expects that the proposed reporting
requirement would impose a minimal additional burden.
The proposed rule would eliminate the current requirement to
include the number of events reported to the NRC during the reporting
period. The current reporting requirement would be eliminated because
the NRC has access to this information through other avenues and
reporting it twice would be unnecessary.
Proposed Sec. 26.217(c) would amend the portions of current Sec.
26.71(d) that require licensees and other entities to analyze the FFD
program performance data semi-annually. The proposed paragraph would
require licensees and other entities to analyze FFD program performance
data annually, rather than semi-annually, and retain the requirement
that actions must be taken to correct program weaknesses. NRC
experience in reviewing FFD program performance reports since the rule
was first promulgated has shown that reporting twice per year is
unnecessary to ensure the continuing effectiveness of FFD programs.
Therefore, the proposed rule would relax the semi-annual analysis and
reporting requirement. Further, the proposed paragraph would require
licensees and other entities to retain for 3 years records of the data,
analysis, and corrective actions taken, which is the same as the
current requirement in Sec. 26.71(d). However, the proposed rule would
add a requirement to retain the documentation until completion of any
legal proceedings related to an FFD violation to ensure that the
records remain available should an individual, the NRC, a licensee, or
another entity who would be subject to this rule require access to them
in a legal or regulatory proceeding.
Proposed Sec. 26.217(d) would retain the last sentence of current
Sec. 26.71(d), which requires that any licensee who temporarily
suspends an individual's authorization or takes administrative actions
on the basis of a non-negative initial test result for marijuana or
cocaine [under the provisions of current Sec. 26.24(d)] must report
the results in the annual summary by processing stage (i.e., initial
testing at the licensee testing facility, testing at the HHS-certified
laboratory, MRO determination). The proposed paragraph would continue
to require that the report must include the number of administrative
actions taken against individuals for the reporting period. However,
the term, ``temporarily suspend,'' would be eliminated from the
proposed paragraph and replaced with the term, ``administratively
withdraw authorization,'' in response to stakeholder requests at the
public meetings discussed in Section V. The stakeholders noted that an
individual is either authorized to perform job duties under Part 26 or
not, and that the concept of suspending an individual's authorization
is conceptually inconsistent. The NRC concurred with this observation
and, therefore, eliminated the inaccurate phrase from the proposed
rule.
Proposed Sec. 26.217(e) would amend portions of current Sec.
26.71(d) to require licensees and other entities to submit the annual
summary to the NRC by March 1 of the following year, rather than the
current requirement of a semi-annual summary to be reported within 60
days of the end of each 6-month reporting period. This proposed change
would be made for consistency with the revised requirement to submit
the report semi-annually in proposed Sec. 26.217(c), as discussed with
respect to that paragraph.
Proposed Sec. 26.217(f) would retain the requirement in current
Sec. 26.71(d) that program performance data may be submitted in a
consolidated report as long as the data are reported separately for
each site.
Proposed Sec. 26.217(g) would introduce a new requirement that C/
Vs who maintain an approved drug and alcohol testing program must
submit to the NRC the same program performance data that would be
required from licensees and other entities who would be subject to the
proposed rule, either directly or via the licensee or other entity to
whom the C/V provides services, ensuring that duplicate reports are not
provided to the NRC. This proposed requirement is needed because the
proposed rule would apply directly to C/Vs who maintain licensee-
approved programs, rather than applying only to licensees under the
current rule, as discussed with respect to proposed Sec. 26.3(d).
Section 26.219 Reporting Requirements
A new Sec. 26.219 [Reporting requirements] would replace current
Sec. 26.73 [Reporting requirements] and combine them with current
Section 2.8(e)(4), (e)(5), and (e)(6) in Appendix A to Part 26. The
proposed section would group into one section reporting requirements
that are interspersed throughout the current rule to meet Goal 6 of
this rulemaking, which is to improve clarity in the organization and
language of the rule.
Proposed Sec. 26.219(a) [Required reports] would be added to
introduce the proposed section, consistent with Goal 6 of this
rulemaking, which is to improve clarity in the organization and
language of the rule, by specifying the categories of significant
events that licensees and other entities would report to the NRC (i.e.,
significant violations of the FFD policy, significant FFD program
failures, and errors in drug and alcohol testing). The second sentence
of the proposed paragraph would retain the requirement in current Sec.
26.73(c) that significant events must be reported under this section,
rather than under the provisions of 10 CFR 73.71.
Proposed Sec. 26.219(b) [Significant FFD policy violations or
programmatic failures] would reorganize and amend current Sec.
26.73(a)(1), (a)(2), and (b). Proposed Sec. 26.219(b) would retain the
requirement in current Sec. 26.73(b) that notifications of events must
be made to the NRC Operations Center within 24 hours of their
discovery, but the proposed rule would present this requirement at the
beginning of the paragraph to clarify that it applies to all of the
events that are listed in the proposed paragraph.
Proposed Sec. 26.219(b)(1) would amend current Sec. 26.73(a)(1),
which requires licensees to report the sale, use, or possession of
illegal drugs within a protected area. The proposed paragraph would add
a requirement for licensees and other entities also to report the
consumption or presence of alcohol in a protected area. This proposed
change would be made for consistency with the NRC's increased concern
with the adverse effects of alcohol abuse on safe performance, as
discussed with respect to proposed Sec. 26.75(e). The proposed change
would also be consistent with the revised performance objective in
proposed Sec. 26.23(d), which is to provide reasonable assurance that
the workplaces subject to this part are free from the presence and
effects of illegal drugs and alcohol, as discussed with respect to that
paragraph. The consumption or presence of alcohol in a protected area
would constitute a significant programmatic failure in achieving this
performance objective.
Proposed Sec. 26.219(b)(2) would amend current Sec. 26.73(a)(2),
which requires licensees to report any acts by licensed operators and
supervisory personnel involving the sale, use, or possession of a
controlled substance; resulting in confirmed positive tests on such
persons; involving consumption of alcohol within the protected area; or
resulting in a determination of unfitness
[[Page 50614]]
for scheduled work due to the consumption of alcohol. The proposed rule
would expand the current reporting requirement to include SSNM
transporter personnel and FFD program personnel. The proposed change
would be made to ensure that the NRC is informed of events involving
these individuals because of the important roles they play in assuring
public health and safety and the common defense and security, in the
former case, and the integrity of the FFD program, in the latter.
Proposed Sec. 26.219(b)(2)(i) would retain current Sec.
26.73(a)(2)(i), which requires licensees and other entities to report
any acts by the subject individuals that involve the use, sale, or
possession of a controlled substance.
Proposed Sec. 26.219(b)(2)(ii) would combine and amend current
Sec. 26.73(a)(2)(ii) and (a)(2)(iv), which require licensees and other
entities to report any confirmed positive tests on such persons and any
acts by the subject individuals that result in a determination of
unfitness for scheduled work due to the consumption of alcohol,
respectively. The proposed paragraph would amend the current
requirements by requiring licensees and other entities to report any
acts by the subject individuals that result in a determination that the
individual has violated the licensee's or other entity's FFD policy
(including subversion as defined in proposed Sec. 26.5 [Definitions]).
This proposed change would be made for consistency with two other
changes to the proposed rule: (1) The addition of validity testing
requirements to the proposed rule, as discussed with respect to
proposed Sec. 26.31(d)(3)(i), and (2) the new requirements in proposed
Subpart D [Management actions and sanctions] to impose the same
sanctions for confirmed positive alcohol test results as those required
for confirmed positive drug test results, as discussed with respect to
proposed Sec. 26.75(e). Therefore, the proposed rule would require
licensees and other entities to report confirmed non-negative validity
test results, any other acts to subvert or attempt to subvert the
testing process, and confirmed positive alcohol test results for these
individuals.
Proposed Sec. 26.219(b)(2)(iii) would amend current Sec.
26.73(a)(2)(iii), which requires licensees and other entities to report
any events involving the consumption of alcohol within the protected
area by the subject individuals, by adding the requirement to report
any acts involving the consumption of alcohol while performing the job
duties that require these individuals to be subject to this part. This
proposed change would be made for consistency with the proposed
addition of SSNM transporters and FFD program personnel to this
paragraph, as discussed with respect to proposed Sec. 26.219(b)(2),
because transporter and FFD program personnel typically do not work
within a protected area. However, the NRC maintains an interest in the
consumption of alcohol by the individuals listed in proposed Sec.
26.219(b)(2) while they are performing the duties that require them to
be subject to this part at any location.
Proposed Sec. 26.219(b)(3) would be added to establish a new
requirement for licensees and other entities to report any intentional
act that casts doubt on the integrity of the FFD program. Because of
the wide array of possible intentional acts that could cast doubt on
the integrity of the FFD program and would be of concern to the NRC,
the proposed rule would not specify the acts that licensees and other
entities must report. However, such intentional acts may include, but
would not be limited to: (1) Notifying individuals, outside of the FFD
program's normal notification procedures, that they will be selected
for random or followup testing on a particular date or at a specific
time so that the individuals have sufficient time available to attempt
to mask drug use by, for example, obtaining a substitute urine specimen
or an adulterant, drinking large amounts of liquid in order to provide
a dilute urine specimen, or leaving the site to avoid testing; (2)
attempting to divert or tamper with urine specimens that are being
prepared for transfer to a licensee testing facility or HHS-certified
laboratory by stealing the specimens, substituting specimens in the
package, or altering the specimens' custody-and-control documentation;
(3) attempting to tamper with testing devices and instruments so that
they provide false negative test results; (4) collusion by collection
site personnel, an MRO, or MRO staff with an individual who is subject
to testing to alter the individual's test results; and (5) attempts by
information technology personnel to alter the software that is used by
the FFD program to randomly select individuals for testing to ensure
that specific individuals are not selected. The intentional acts that
the proposed rule would require licensees and other entities to report
could involve any aspect of the operations of the FFD program and the
testing process.
The proposed rule would add this new reporting requirement because
of other changes to the proposed rule that would permit licensees and
other entities to rely on other Part 26 programs to a much greater
extent than currently. The proposed rule would permit licensees and
other entities to rely on testing performed by another Part 26 program,
FFD training, other programs' suitable inquiries and determinations of
fitness, and audits. Therefore, intentional acts that cast doubt on the
integrity of one FFD program may also indirectly affect the integrity
and effectiveness of other FFD programs. The NRC would require
reporting of these acts in order to monitor their impacts and ensure
that other FFD programs that may be affected are informed of the
problem so that they may take corrective actions, if necessary.
Proposed Sec. 26.219(b)(4) would be added to require licensees and
other entities to report any programmatic failure, degradation, or
discovered vulnerability of an FFD program that may permit undetected
drug or alcohol use or abuse by individuals within a protected area, or
by individuals who are assigned to perform job duties that require them
to be subject to this part. In Item 10.1 of NUREG-1385, the NRC
emphasized that the NRC expects licensees to exercise prudent judgment
in determining whether unusual situations should be reported and that
the significant events the licensees must report are not limited to the
examples contained in the rule. However, the NRC understands that many
significant events that would be useful for formulating public policy
or that the NRC should respond to in a timely fashion have not been
reported because licensee management decided not to report the event
unless it was specifically required by the rule. Therefore, the
proposed rule would add Sec. 26.219(b)(4) to clarify that significant
events and programmatic failures are not limited to those listed in
proposed Sec. 26.219(b), but would include any programmatic failures
or weaknesses that potentially could permit substance abuse to be
undetected.
Proposed Sec. 26.219(c) [Drug and alcohol testing errors] would
reorganize and amend current requirements for reporting errors in drug
and alcohol testing for organizational clarity. The proposed rule would
retain the current requirements for licensees and other entities to
investigate and take corrective actions for drug and alcohol testing
errors in proposed Sec. Sec. 26.137(f) and 26.167(g) for licensee
testing facilities and HHS-certified laboratories, respectively, but
would move the reporting requirements to this proposed paragraph.
[[Page 50615]]
Proposed Sec. 26.219(c)(1) would update the portion of current
Section 2.8(e)(4) in Appendix A to Part 26 that mandates that licensees
and other entities must report within 30 days of completing an
investigation of any testing errors or unsatisfactory performance in
blind performance testing at either a licensee testing facility or an
HHS-certified laboratory. The proposed paragraph would amend the
current requirement by specifying that the report of the incident must
include a description of the corrective actions taken or planned.
Although licensees and other entities have consistently included a
description of corrective actions in such reports, the proposed rule
would add this as a requirement to clarify the NRC's intent in the
language of the rule.
In addition, the proposed paragraph would add cross-references to
other sections of the proposed rule that define processes that may also
result in the identification of errors, including the reviews required
under proposed Sec. 26.39 [Review process for fitness-for-duty
violations] and proposed Sec. 26.185 [Determining a fitness-for-duty
policy violation]. The NRC intended, in the original rule, that testing
or process errors discovered in any part of the program, including
these review processes, would be investigated as an unsatisfactory
performance of a test. Thorough investigation and reporting of such
test results will continue to assist the NRC, the licensees, HHS, and
the HHS-certified laboratories in preventing future occurrences.
Therefore, this proposed change would be made to clarify that the
requirement to investigate, correct, and report errors would not be
limited only to errors identified through blind performance testing in
licensee testing facilities and HHS-certified laboratories but also
would apply to errors identified through any means.
Proposed Sec. 26.219(c)(2) would amend the portion of current
Section 2.8(e)(5) in Appendix A to Part 26 that requires licensees to
promptly notify the NRC if a false positive error occurs on a blind
performance test sample. The proposed paragraph would replace the
current requirement that the report must be made ``promptly'' with a
requirement to report the false positive error within 24 hours of the
discovery. This proposed change would be made as a result of the public
meetings discussed in Section V, during which the stakeholders noted
that ``promptly'' is vague. Therefore, the proposed rule would clarify
the current requirement by establishing a 24-hour time limit for the
notification to meet Goal 6 of this rulemaking, which is to improve
clarity in the language of the rule.
The proposed rule would establish a 24-hour time limit because
false positive test results would cause licensees and other entities to
impose sanctions on individuals who have not, in fact, abused drugs.
The HHS views false positive test results very seriously and may de-
certify a laboratory as a result. The 24-hour time limit would be
necessary to ensure that the NRC can quickly notify the HHS of the
problem so that the HHS may initiate the applicable steps required
under the HHS Guidelines for such circumstances. In addition, the NRC
may use the information to inform other licensees and entities who rely
on the same HHS-certified laboratory of the problem, so that they may
determine whether to require the laboratory or a second laboratory to
retest any specimens they have submitted.
Proposed Sec. 26.219(c)(3) would be added to require licensees and
other entities to report, within 24 hours of the discovery, any false
negative errors identified through quality assurance checks of validity
screening devices, if the licensee or other entity uses these devices
for validity testing at a licensee testing facility. The proposed
reporting requirement would be necessary to ensure that the NRC is
aware of any device failures, so that other Part 26 programs that rely
on the devices may be informed of the error and stop using them until
the cause of the error is identified and the problem is resolved.
Continued use of unreliable devices may permit attempts to subvert the
testing process to go undetected with the result that individuals who
have engaged in a subversion attempt may be granted or allowed to
maintain authorization.
The proposed rule would not require licensees and other entities to
report false positive errors identified through quality assurance
checks of validity screening devices for two reasons. First, other
provisions of the proposed rule would prohibit licensees and other
entities from taking management actions or imposing sanctions on
individuals on the basis of validity screening test results, as
discussed with respect to proposed Sec. 26.75(h). Second, donors would
be protected from adverse consequences of false positive errors because
any specimen that yields a non-negative validity screening test result
would be forwarded to an HHS-certified laboratory for initial and
confirmatory testing, if required, before a licensee or other entity
would be permitted to act, as discussed with respect to proposed Sec.
26.137(c). Therefore, reporting of false positive errors would be
unnecessary to protect the interests of either donors or the public.
Proposed Sec. 26.219(d) [Indicators of programmatic weaknesses]
would be added to require licensees and other entities to document,
trend, and correct non-reportable FFD issues that identify programmatic
weaknesses under the licensee's or other entity's corrective action
program. The proposed rule would add this requirement because some
licensees have not documented, trended, or corrected programmatic
weaknesses, while others have created separate systems, with the result
that corrective actions for FFD program weaknesses have not been timely
or effective. Therefore, the proposed rule would add these requirements
for consistency with Criterion XVI in Appendix B to 10 CFR Part 50 to
FFD programs and to meet Goal 3 of this rulemaking, which is to improve
the effectiveness and efficiency of FFD programs.
The proposed paragraph would also require licensees and other
entities to document, trend, and correct any programmatic weaknesses in
a manner that protects individuals' privacy. For example, the proposed
paragraph would prohibit licensees and other entities from documenting
a single non-negative drug test result in the corrective action
program, because such documentation, along with other cues in the work
environment, would permit any individual who has access to the
corrective action system easily to identify the donor. However, under
the proposed rule, the NRC would expect licensees and other entities to
document, trend, analyze, and take corrective actions for an increase
in the rate of confirmed non-negative test results in the aggregate, if
the licensee or other entity determines that the increasing trend
indicates programmatic weaknesses rather than improved effectiveness of
the FFD program. The proposed requirement to protect individuals'
privacy within the corrective action program would be added to meet
Goal 7 of this rulemaking, which is to protect the privacy and due
process rights of individuals who are subject to Part 26.
Subpart K--Inspections, Violations, and Penalties
A new Subpart K [Inspections, Violations, and Penalties] would be
added to the proposed rule to combine into one subpart current
Sec. Sec. 26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal
penalties]. Proposed Sec. 26.221 [Inspections] would retain the
requirements in current Sec. 26.70.
[[Page 50616]]
Proposed Sec. 26.223 [Violations] would retain the requirements in
current Sec. 26.90 [Violations]. Proposed Sec. 26.225 [Criminal
penalties] would retain the requirements in current Sec. 26.91
[Criminal penalties].
Appendix A would be deleted in its entirety.
VII. Issues for Public Comment
The NRC seeks public comment on the following issues. Public
comments should be submitted to the NRC as indicated under the heading
ADDRESSES.
1. Proposed Sec. 26.75 in Subpart D would increase the sanctions
for certain testing-related actions by requiring that: ``Any act or
attempted act to subvert the testing process, including refusing to
provide a specimen and providing or attempting to provide a substituted
or adulterated specimen, for any test required under this part must
result in permanent denial of authorization,'' and ``for individuals
whose authorization was denied for 5 years * * * any subsequent
violation of the drug and alcohol provisions of an FFD policy must
immediately result in permanent denial of authorization.'' The NRC
requests comments regarding these proposed changes specifically when
compared to the 5-year ban available through the agency's enforcement
policy for other acts of deliberate misconduct.
2. Proposed Sec. 26.119 [Determining ``shy'' bladder] would
establish a process for determining whether there is a medical reason
that a donor is unable to provide a urine specimen of at least 30 mL.
The NRC added this proposed section in response to stakeholder requests
and adapted the process from the DOT's Procedures for Transportation
Workplace Drug and Alcohol Testing Programs (49 CFR 40.197). The DOT
Procedures also include processes for determining whether there is a
medical reason that a donor is unable to provide a specimen of oral
fluids (49 CFR 40.263) or a breath specimen (49 CFR 40.265) of
sufficient quantity to support alcohol testing. The NRC invites
comments on whether the NRC should consider incorporating these
processes for insufficient oral fluids and breath specimens in Part 26.
3. Proposed Sec. 26.31(d)(3)(iii)(C) would permit licensees and
other entities to specify more stringent cutoff levels for the panel of
drugs for which testing is required under this part without informing
the NRC within 60 days and without obtaining the written approval of
the NRC. Proposed Sec. 26.31(d)(1)(i)(D) and (d)(1)(ii) would also
permit licensees and other entities to test for drugs and drug
metabolites in addition to those specified in proposed Sec.
26.31(d)(1) without informing or obtaining the written approval of the
NRC. However, the proposed paragraphs would require that the scientific
and technical suitability of the more stringent cutoff levels and of
the assays and cutoff levels used to test for additional drugs or drug
metabolites must be evaluated and certified, in writing, by a
qualified, independent forensic toxicologist. Certification by a
forensic toxicologist would not be required in three circumstances: (1)
If the HHS issues more stringent cutoff levels in the HHS Guidelines
and the licensee or other entity adopts the revised HHS cutoffs; (2) if
the HHS Guidelines are revised to authorize use of the assay in testing
for the additional drug or drug metabolites and the licensee or other
entity uses the cutoff levels established in the HHS Guidelines for the
drug or drug metabolites; and (3) if the licensee or other entity
received written approval from the NRC for the lower cutoff levels and/
or for testing for the additional drugs or drug metabolites, under
current Section 1.1(2) in Appendix A to Part 26. The proposed
paragraphs differ from the current requirement in Section 1.1(2) of
Appendix A to Part 26. The NRC requests comments regarding these
proposed changes.
4. Proposed Sec. Sec. 26.133 and 26.163 would raise the cutoff
levels for initial and confirmatory tests for opiates from 300
nanograms (ng) per milliliter (mL) to 2,000 ng/mL. The proposed rule
would also require testing for 6-acetylmorphine (6-AM), a metabolite
that comes only from heroin, using a 10 ng/mL confirmatory cutoff level
for specimens that tested positive on the initial test. The proposed
cutoff levels and new test would be consistent with those used by HHS
and DOT, and would reduce the number of specimens in Part 26 programs
that test positive for opiates at an HHS-certified laboratory but are
subsequently determined to be negative by the MRO after consultation
with the donor. The NRC invites comment on these proposed changes.
5. In proposed Sec. Sec. 26.131, 26.137, 26.161, and 26.167, the
NRC would add new requirements for validity testing of urine specimens
to detect specimens that may have been adulterated, substituted, or
diluted. The new requirements are adapted from practices the HHS
published in the Federal Register on April 13, 2004 (69 FR 19643) as a
final rule. The NRC invites public comment on the following issues
related to the proposed validity testing requirements.
a. Proposed Sec. 26.137 would establish quality assurance and
quality control requirements for conducting validity and drug tests of
urine specimens. The NRC seeks input regarding any technical and
methodological barriers to implementing these requirements at licensee
testing facilities.
b. Proposed Sec. Sec. 26.161(d) and 26.185(h) would establish
criteria and procedures for determining whether a specimen has been
substituted. A specimen would be reported by the HHS-certified
laboratory to the MRO as substituted if it has a creatinine
concentration of less than 2 mg/dL and specific gravity of less than or
equal to 1.0010, or equal to or greater than 1.0200. For the HHS-
certified laboratory to report a specimen as substituted, results in
these ranges would be necessary on both the initial and confirmatory
creatinine and specific gravity tests on two separate aliquots of the
specimen. The NRC invites comments on the proposed provisions.
6. Proposed Sec. 26.183(a) requires that ``The MRO shall be
knowledgeable of this part and of the FFD policies of the licensees and
other entities for whom the MRO provides services.'' The NRC invites
comments on whether Part 26 should establish specific training
requirements for the MRO related to this part and the licensee's or
other entity's programs for which the MRO provides services.
7. The NRC is considering incorporating future changes to the draft
HHS Guidelines that were published as a proposed rule for public
comment in the Federal Register on April 13, 2004 (69 FR 19672)
relating to the permission in this proposed Part 26 rule for licensees
and other entities to use non-instrumented validity tests to determine
whether a urine specimen appears to be adulterated, diluted, or
substituted and requires further testing at an HHS-certified
laboratory. Proposed Part 26 would permit licensees and other entities
to use these devices for validity screening tests, in lieu of the
instrumented validity testing required in the April 13, 2004, final
version of the HHS Guidelines. Should any changes be made to those
draft HHS Guidelines between issuing this proposed rule and issuing the
final 10 CFR Part 26 rule, those changes would be considered for
incorporation. Any comments related to the potential incorporation of
those changes are of interest.
8. Proposed Subpart I, Managing Fatigue, includes many requirements
related to worker fatigue at nuclear power plants. The NRC is
especially interested in comments on the following provisions:
[[Page 50617]]
a. Proposed Sec. 26.199(d)(2)(ii) and (d)(2)(iii) would require
licensees to provide individuals who are subject to the proposed work
hour limits with at least one 24-hour rest break in any 7-day period
and at least one 48-hour rest break in any 14-day period, except during
the first 14 days of any outage, as well as certain other circumstances
for security force personnel.
b. Proposed Sec. 26.199(d)(3) would permit licensees to waive
individual work hour limits and rest break requirements only in
circumstances in which it is necessary to mitigate or prevent a
condition adverse to safety, or to maintain the security of the
facility. Proposed Sec. 26.197(e)(1) would require licensees to report
the number of waivers granted in a year.
c. Proposed Sec. 26.199(f) would prohibit job duty groups that are
subject to work hour controls from working more than a maximum
collective average of 48 hours per person per week, except during the
first 8 weeks of any outage, as well as certain other circumstances for
security force personnel.
9. As a means of determining the flexibility of the proposed rule
work hour controls in Sec. 26.199, the NRC is seeking public comment
on work-scheduling examples that meet the requirements of the proposed
rule and whether such schedules afford a reasonable degree of
flexibility to licensee management.
10. The NRC is seeking comment on the exclusions from certain work
hour controls that would be allowed by proposed Sec. Sec.
26.199(d)(2)(iii), (f)(1) and (f)(2) during maintenance and refueling
outages, and how these exclusions could affect human error. The NRC is
specifically interested in whether a more precisely defined rule scope
with more limited outage exclusions would better meet the stated
objectives of the rule.
11. The NRC is seeking public comment on alternatives to the group
work hour controls that could also address cumulative fatigue, such as
individual work hour limits based on a longer term (e.g., monthly or
quarterly).
12. Proposed Sec. 26.199(a) would require any individual who
performs duties within specified job duty groups to be subject to the
work hour control provisions in Sec. 26.199. Other individuals, beyond
those specified within the scope of Sec. 26.199(a), might
substantially impact the outcome of risk-significant work, such as
certain engineers (e.g., Shift Technical Advisors). The NRC requests
comment on the inclusion of other individuals in the scope of Sec.
26.199(a). The NRC is also seeking comments on an alternative approach
for identifying the specific job functions that would be subject to
these requirements. Specifically, the NRC is interested in whether, as
an alternative, the scope should instead be structured to define
attributes of the job functions (e.g., time-critical nature of
decisions needed to ensure public health and safety, operational
control of risk-important equipment) that would fall within the scope
of the proposed work hour control provisions in Sec. 26.199. Under
such an alternative, the licensee would then be required to identify
the specific job functions that fit the defined attributes.
13. The NRC is considering amending 10 CFR 50.109, 70.76, and 76.76
to exclude certain future changes to Part 26 from current backfit
requirements. The scope of the exclusions would be limited to only
those changes to Part 26 that would be necessary to incorporate
relevant revisions to the HHS Guidelines when they are published by HHS
as final rules. Examples of changes to the HHS Guidelines that may be
incorporated into Part 26 in future rulemakings may include, but would
not be limited to (1) Adopting changes to the cutoff levels established
in the Guidelines; (2) the addition or deletion of drugs and
adulterants for which testing would be required; and (3) changes in the
specimens, instruments, or assays used in drug and validity testing.
The NRC requests comment on excluding such future changes to Part 26
from backfit analysis requirements.
14. Proposed Sec. Sec. 26.135(b) and 26.165(a)(4) and (b)(1) would
prohibit licensees and other entities, the MRO, and the NRC from
initiating testing of the specimen in Bottle B or retesting an aliquot
from a single specimen without the donor's written permission. The NRC
is considering an alternative approach that would permit a licensee or
other entity to initiate testing of the specimen in Bottle B or
retesting an aliquot from a single specimen without the donor's written
permission only if all of the following conditions are met: (1) The
first results from testing the specimen were confirmed as non-negative
by the MRO; (2) the donor has requested a review under proposed Sec.
26.39 or initiated legal proceedings; and (3) the testing is conducted
in accordance with proposed Sec. 26.165(c)-(e), as applicable. Under
either the proposed provisions or the alternative approach, the
proposed rule would require the licensee or other entity to
administratively withdraw the donor's authorization until the results
from Bottle B or the retest results are available and to rely only on
those results in determining whether the licensee or other entity would
be required to take management actions or impose sanctions on the
donor. The NRC is seeking an appropriate balance between protecting
donors' rights to privacy and due process under the rule and the
protection of public health and safety and the common defense and
security, and invites public comment on the proposed and alternative
approaches.
15. The NRC is seeking comment regarding the administrative
reporting burden that the proposed rule provisions would create.
Provide any comments as described in Section XIII, Paperwork Reduction
Act Statement, of this notice.
VIII. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 10 CFR Part 26 under one or more of
Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule
would be subject to criminal enforcement.
IX. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register on September 3, 1997 (62 FR
46517), this rule is classified as Compatibility Category ``NRC.''
Compatibility is not required for Category ``NRC'' regulations. The NRC
program elements in this category are those that relate directly to
areas of regulation reserved to the NRC by the Atomic Energy Act of
1954, as amended (AEA), or the provisions of Title 10 of the Code of
Federal Regulations. Although an Agreement State may not adopt program
elements reserved to the NRC, it may wish to inform its licensees of
certain requirements via a mechanism that is consistent with the
particular State's administrative procedure laws but does not confer
regulatory authority on the State.
X. Plain Language
The Presidential memorandum dated June 1, 1998, entitled ``Plain
Language in Government Writing'' directed that the Government's writing
be in plain language. This memorandum was published on June 10, 1998
(63 FR 31883). In complying with this directive, editorial changes have
been made in these proposed revisions to improve the organization and
readability of the existing language of the paragraphs being revised.
The NRC requests comments on the proposed rule specifically with
respect to the clarity
[[Page 50618]]
and reflectiveness of the language used. Comments should be sent to the
address listed under the ADDRESSES caption of the preamble.
XI. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards developed or adopted by voluntary consensus standards bodies
unless the use of such a standard is inconsistent with applicable law
or otherwise impractical. There are no consensus standards regarding
the methods for performing drug and alcohol testing, fatigue
assessments, or other aspects of Fitness For Duty Programs, that would
apply to the requirements that would be imposed by this rule, with the
exception of short-term work hour limits for licensed operators, senior
operators, and the shift technical advisor. The NRC notes the inclusion
of these limits in a 1988 American Nuclear Society standard on
administrative controls and quality assurance for the operational phase
of nuclear power plants, ANSI/ANS-3.2-1998.
The NRC does not believe that this standard is sufficient, as it
does not apply to other categories of workers who would be subject to
the provisions of this proposed rule, such as maintenance, health
physics, chemistry, fire brigade, and security force personnel.
Additionally, the standard is insufficient because it does not provide
the comprehensive fatigue management approach that this proposed rule
would, and is lacking provisions to mitigate long-term fatigue, provide
a process for self-declarations of fatigue by workers, and provide for
rest breaks.
Further, the standard does not adequately mitigate short-term
fatigue, because it does not restrict deviations from the short-term
limits to only those unique instances necessary for the safety and
security of the plant. The standard only requires that exceptions be
minimized and that they be approved by the plant manager or designee.
The provisions in the standard are identical to those currently
incorporated as requirements in some nuclear power plants' technical
specifications. Section IV. D explains that enforcement of the
technical specification requirements is complicated by the fact that
the language is largely advisory, and key terms have not been defined,
with the result that the requirements have been interpreted
inconsistently.
For the reasons noted above, the ANS standard cannot be used in
lieu of the proposed rule provisions to meet the objective of
comprehensive fatigue management.
XII. Finding of No Significant Environmental Impact: Environmental
Assessment
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
Subpart A of 10 CFR Part 51, that this rule, if adopted, would not be a
major Federal action significantly affecting the quality of the human
environment and, therefore, an environmental impact statement is not
required. The basis for this determination reads as follows:
The proposed rule, if adopted, would amend the NRC's requirements
for FFD programs which are contained in 10 CFR Part 26 to address the
following needs: (1) Update and enhance the consistency of 10 CFR Part
26 with advances in other relevant Federal rules and guidelines,
including the U.S. Department of Health and Human Services Mandatory
Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines)
and other Federal drug and alcohol testing programs (e.g., those
required by the U.S. Department of Transportation [DOT]) that impose
similar requirements on the private sector; (2) strengthen the
effectiveness of FFD programs at nuclear power plants in ensuring
against worker fatigue adversely affecting public health and safety and
the common defense and security by establishing clear and enforceable
requirements for the management worker fatigue; (3) improve the
effectiveness and efficiency of FFD programs; (4) improve consistency
between FFD requirements and access authorization requirements
established in 10 CFR 73.56, as supplemented by orders to nuclear power
plant licensees dated January 7, 2003; (5) improve 10 CFR Part 26 by
eliminating or modifying unnecessary requirements; (6) improve clarity
in the organization and language of the rule; and (7) protect the
privacy and due process rights of individuals who are subject to 10 CFR
Part 26.
It would also grant, in part, a December 30, 1993, petition for
rulemaking (PRM-26-1) from Virginia Electric and Power Company (now
Dominion Virginia Power) which requested a relaxation in required audit
frequencies and PRM-26-2, dated December 28, 1999, from Barry Quigley,
by establishing clear and enforceable requirements concerning the
management of worker fatigue. In addition, the proposed rule would
continue to apply to all personnel with unescorted access to the
protected area of a nuclear power plant, consistent with the
Commission's denial (SRM-SECY-04-0229) of an exemption request by IBEW
Local 1245 dated March 13, 1990, and renewed on January 26 and December
6, 1993.
The proposed rule would not significantly increase the probability
or consequences of an accident. No changes are being made in the types
or quantities of radiological effluents that may be released off site,
and there is no significant increase in public or occupational
radiation exposure since there is no change to facility operations that
could create a new or affect a previously analyzed accident or release
path.
With regard to non-radiological impacts, no changes are being made
to non-radiological plant effluents and there are no changes in
activities that would adversely affect the environment. Therefore,
there are no significant non-radiological impacts associated with the
proposed action.
The primary alternative to this action would be the no action
alternative. The no action alternative would result in continued
inconsistencies between FFD and access authorization requirements,
continued difficulties in implementation of the regulation due to the
current organization of the rule, continued use of less current
technologies and advances in testing and a continued lack of a
comprehensive fatigue management program. The no action alternative
would provide little or no safety, risk, or environmental benefit.
No outside agencies or persons were consulted, or outside sources
used or relied upon, in the preparation of this environmental
assessment.
The determination of this environmental assessment is that there
will be no significant environmental impact from this action. However,
the general public should note that the NRC is seeking public
participation. Comments on any aspect of the environmental assessment,
provided above, may be submitted to the NRC as indicated under the
ADDRESSES heading.
The NRC has sent a copy of this proposed rule to every State
Liaison Officer and requested their comments on the environmental
assessment.
XIII. Paperwork Reduction Act Statement
This proposed rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq). This rule has been submitted to the Office of
Management and Budget for review and approval of the information
collection requirements.
[[Page 50619]]
Type of submission, new or revision: New.
The title of the information collection: 10 CFR Part 26, ``Fitness
for Duty Programs.''
The form number if applicable: Not applicable.
How often the collection is required:
On occasion: Significant FFD policy violations or programmatic
failures; drug and alcohol testing errors; indicators of programmatic
weaknesses; possible impairment of an NRC employee or NRC contractor;
Annually: FFD program performance data.
Who will be required or asked to report:
--Licensees authorized to operate a nuclear power reactor;
--Licensees authorized to possess, use, or transport formula
quantities of strategic special nuclear material (SSNM) under 10 CFR
Part 70;
--Corporations, firms, partnerships, limited liability companies,
associations, or other organizations that obtain a certificate of
compliance or an approved compliance plan under 10 CFR Part 76, if the
entity engages in activities involving formula quantities of SSNM; and
--Contractor/vendors (C/Vs) who implement FFD programs or program
elements, to the extent that licensees and other entities rely upon
those C/V FFD programs or program elements to meet the requirements of
this part.
An estimate of the number of annual responses: 5,540 (5,504
responses plus 36 recordkeepers).
The estimated number of annual respondents: 36 FFD programs (used
by 65 nuclear power plants, 2 fuel cycle facilities, 2 C/Vs, and one
mixed-oxide fuel fabrication facility), of which 31 FFD programs (used
by 65 nuclear power plant facilities) are also required to include
fatigue management programs with additional reporting and recordkeeping
requirements.
An estimate of the total number of hours needed annually to
complete the requirement or request: 545,942 hours, including 125,239
hours for one-time program implementation, 25,727 hours annually for
reporting (an average of 715 hours per respondent) + 394,976 hours
annually for recordkeeping (an average of 10,972 hours per
recordkeeper).
Abstract: The Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations for its Fitness for Duty (FFD) programs to
completely revise 10 CFR Part 26 to update and clarify the regulations,
and also add requirements for fatigue management at nuclear power
plants. The proposed rule would ensure that individuals subject to
these regulations are trustworthy and reliable, as demonstrated by
avoiding substance abuse, and are otherwise fit for duty. The proposed
rule would also ensure that workplaces subject to these regulations are
free of the presence and effects of illegal drugs and alcohol.
The recordkeeping and reporting requirements in the proposed rule
include provisions requiring licensees and other entities to develop
and maintain policies and procedures; retain records of training,
qualification and authorization of individuals; retain records related
to drug and alcohol collections and tests; retain other records related
to the collection, testing and review processes; report FFD program
performance and significant violations, program failures and testing
errors; and retain records related to employee assistance programs.
Records and reports are also required under the proposed new fatigue
management component of the FFD program.
The recordkeeping and reporting requirements would be mandatory for
licensees and other entities subject to the rule. The NRC would use the
reports to assess the effectiveness of FFD programs for those subject
to the rule, and whether the provisions are implemented as the NRC
intends.
The U.S. Nuclear Regulatory Commission is seeking public comment on
the potential impact of the information collections contained in this
proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O1-F21, Rockville, MD 20852. The OMB clearance package and
rule are available at the NRC worldwide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the
signature date of this proposed rule and are also available at the rule
forum site, http://ruleforum.llnl.gov.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
above issues, by September 26, 2005, to the Records and FOIA/Privacy
Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail to
[email protected] and to the Desk Officer, Office of Information and
Regulatory Affairs, NEOB-10202, (3150-0146), Office of Management and
Budget, Washington, DC 20503. Comments received after this date will be
considered if it is practical to do so, but assurance of consideration
cannot be given to comments received after this date. You may also
comment by telephone at (202) 395-3087.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
XIV. Regulatory Analysis
The NRC has prepared a draft Regulatory Analysis on this proposed
regulation. The draft regulatory analysis was prepared in accordance
with the NRC's Regulatory Analysis Guidelines (RA Guidelines), NUREG/
BR-0058, Revision 4, dated September 2004. The draft Regulatory
Analysis consists of three parts. First, an aggregate analysis of the
entire rule was performed. Second, a screening review for
disaggregation was performed to identify any individual provisions that
could impose costs disproportionate to the benefits attributable to
each provision. Finally, a separate analysis of the proposed rule's
provisions addressing worker fatigue was performed. A description of
each of these three elements is discussed below. The analysis is
available as discussed above under the ADDRESSES heading. Single copies
may be obtained from the contact listed above under the FOR FURTHER
INFORMATION CONTACT heading. The Commission requests public comment on
the draft Regulatory Analysis. Comments on the draft analysis may be
submitted to the NRC as indicated under the ADDRESSES heading.
A. Aggregate Analysis
Consistent with the RA Guidelines, an aggregate analysis of the
entire rulemaking was performed. The provisions of the rule relating to
drug and alcohol testing (and other general FFD program requirements)
are estimated to result in net present value savings to industry of
$116 million-
[[Page 50620]]
$183 million (using 7 percent and 3 percent real discount rates),
consisting of $2 million in one-time costs and $9 million in annual net
savings. The worker fatigue portions of the proposed rule are estimated
to cost industry $585 million-$913 million net present value (using the
7 percent and 3 percent real discount rates, respectively), consisting
of $19 million in one-time costs and $42 million in annual net costs.
The net present value of the entire proposed rule, including both the
worker fatigue and drug and alcohol testing portions, is estimated to
be a cost to industry of $469 million-$730 million (using 7 percent and
3 percent real discount rates), which consists of $21 million in one-
time costs and $33 million in annual costs. In addition, the proposed
rule is estimated to be a cost to the NRC of $615,000-$947,000 net
present value (using 7 percent and 3 percent real discount rates),
consisting of $30,000 in one-time costs and $45,000 in annual net
costs.
The NRC also separately evaluated the improvement in worker
performance expected from the impact of selected fatigue management
provisions on unplanned reactor scrams, reactor accidents, lost and
restricted work cases (injuries), fire mitigation, and security. Those
present value savings are estimated to be $103 million-$167 million
(using 7 percent and 3 percent real discount rates), and have not been
subtracted from the net present value of the entire proposed rule
listed above because the NRC considers the costs of the proposed rule
to be justified without these quantitative savings, which are only
included to illustrate further justification for the rulemaking.
The NRC concludes that the costs of the rule are justified in view
of the qualitative benefits evaluated in Section 4.1.2 of the draft
Regulatory Analysis. The basic analysis measures the incremental
impacts of the proposed rule relative to a baseline that assumes full
licensee compliance with existing NRC requirements, including current
regulations and any relevant orders or enforcement discretion. The
aggregate analysis is contained in Section 4.1 of the draft regulatory
analysis.
B. Screening Review for Disaggregation
The regulatory analysis also discusses the screening review for
disaggregation performed by the staff. The analysis was performed
consistent with Section 4.3.2 of the RA Guidelines to determine if
there are provisions whose costs are disproportionate to the benefits
and whose inclusion in the aggregate analysis could obscure their
impact, but also responds to the Commission's direction in SRM-01-0134
dated July 23, 2001, that, ``If there is a reasonable indication that a
proposed change imposes costs disproportionate to the safety benefit
attributable to that change, as part of the final rule package the
Commission will perform an analysis of that proposed change in addition
to the aggregate analysis of the entire rulemaking to determine whether
this proposed change should be aggregated with the other proposed
change for the purposes of the backfit analysis. That analysis will
need to show that the individual change is integral to achieving the
purpose of the rule, has costs that are justified in view of the
benefits that would be provided or qualifies for one of the exceptions
in 10 CFR Sec. 50.109(a)(4).'' These results are described in Sections
4.1.4.1 and 4.4.2 of the draft regulatory analysis.
C. Dissaggregation of Worker Fatigue Provisions
Section 4.1.4.2 of the draft Regulatory Analysis summarizes the
division of costs and savings of the fatigue management portions of the
proposed rule, in comparison with the rest of the rule. The worker
fatigue portions of the proposed rule are estimated to cost industry
$585 million-$913 million net present value (using the 7 percent and 3
percent real discount rates, respectively), consisting of $19 million
in one-time costs and $42 million in annual net costs. The NRC
considers fatigue management to be an integral and necessary aspect of
FFD. Fatigue currently is considered to be part of FFD under current
Sec. 26.10(a) and Sec. 26.20(a)(2). However, the NRC included a
summary of the costs associated with the proposed fatigue management
requirements in the aggregate as a courtesy to stakeholders in Section
4.1.4.2 of the draft Regulatory Analysis.
XV. Regulatory Flexibility Act Certification
As required by the Regulatory Flexibility Act, as amended, 5 U.S.C.
605(b), the Commission certifies that this proposed rule, if adopted,
would not have a significant economic impact on a substantial number of
small entities. This proposed rule would affect only licensees
authorized to operate nuclear power reactors; licensees authorized to
possess, use, or transport formula quantities of strategic special
nuclear material (SSNM); corporations who obtain certificates of
compliance or approved compliance plans under Part 76 involving formula
quantities of SSNM; combined license holders; holders of manufacturing
licenses; holders of construction permits; combined license holders and
construction permit applicants with authorization to construct; and
contractor/vendors (C/Vs) who implement FFD programs or program
elements, to the extent that licensees and other entities rely upon
those C/V FFD programs or program elements to meet the requirements of
Part 26. Those above do not fall within the scope of the definition of
``small entities'' set forth in the Regulatory Flexibility Act, or the
Size Standards established by the Nuclear Regulatory Commission (10 CFR
2.810).
XVI. Backfit Analysis
The proposed rule would constitute backfitting as defined in 10 CFR
50.109(a)(1). The NRC has performed a backfit analysis, as described in
Sec. 50.109(c) [which applies to power reactors], Sec. 70.76(b)
[which applies to formula quantity strategic special nuclear material
licensees], and Sec. 76.76(b) [which applies to gaseous diffusion
plants], consistent with the NRC's Regulatory Analysis Guidelines (RA
Guidelines) in NUREG/BR-0058, Revision 4, dated September 2004. The
Commission requests public comment on the draft Backfit Analysis. The
draft Backfit Analysis is included in the draft Regulatory Analysis,
which is available as discussed under the ADDRESSES heading. Single
copies may be obtained from the contact listed under the FOR FURTHER
INFORMATION CONTACT heading. Comments on the draft analysis may be
submitted to the NRC as indicated under the ADDRESSES heading.
A. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion
Plants
The backfit provision of 10 CFR 70.76 applies to currently
operational fuel fabrication facilities. These facilities have been
considered in the aggregate backfit analysis. The planned mixed-oxide
fuel fabrication facility would also be licensed under Part 70, but has
not yet submitted a Part 26 program description. Therefore, the
consideration of the costs to the mixed-oxide fuel fabrication facility
in the regulatory analysis is sufficient for consideration of the
impacts to that facility. Although the backfit provision of 10 CFR
76.76 would apply to gaseous diffusion plants, there are no backfit
impacts because the gaseous diffusion plants licensed by the NRC are
not currently authorized to possess formula quantities of strategic
special nuclear material.
[[Page 50621]]
B. Aggregate Backfit Analysis
The NRC performed an aggregate backfit analysis of all backfits
consistent with Section 4.3.2 of the RA Guidelines. Because the changes
associated with the proposed rule are interrelated and deal with a
single subject area (FFD), the NRC followed its ordinary practice of
assessing the backfitting implications in an aggregate manner,
consistent with the RA Guidelines. The aggregate analysis is provided
in Section 4.4.1 of the draft Part 26 Regulatory Analysis, which is
available as discussed under the ADDRESSES heading. The aggregate
analysis also includes a list of all changes that constitute backfits,
in Exhibits 4-14 and 4-15 of the draft analysis. Exhibit 4-16 of the
draft analysis also includes a list of all changes that were evaluated
for potential cost implications, but were determined to not constitute
backfits, as well as a list of the reasons those changes were
determined to not constitute backfits. A summary of the results of the
aggregate analysis follows.
The NRC determined the backfitting is justified under Sec.
50.109(a)(3), Sec. 70.76(a)(3) and Sec. 76.76(a)(3) because: (1)
There is a substantial increase in the overall level of protection
afforded for the public health and safety or the common defense and
security to be derived from the backfitting; and (2) the costs of
implementation and the annual costs are justified in view of this
increase. The estimated cost of implementation would be $21 million and
the annual net costs would be $42 million, resulting in a net present
value cost of $594 million-$927 million (using 7 percent and 3 percent
real discount rates, respectively).
In determining that the substantial increase standard is met, the
NRC considered safety benefits qualitatively. In this qualitative
consideration, the NRC determined that the proposed FFD rule,
considered in the aggregate, would constitute a substantial increase in
protection to public health and safety by addressing the following six
key areas that have been identified as posing recurring and, in some
cases, significant problems with respect to the effectiveness,
integrity, and efficiency of FFD programs at nuclear facilities.
1. Subversion of the detection/testing process;
2. Regulatory efficiency between 10 CFR Part 26 and other related
Federal rules and guidelines;
3. Ineffective/unnecessary FFD requirements;
4. Ambiguous or imprecise regulatory language in 10 CFR Part 26;
5. Technical developments; and
6. FFD program integrity and protection of individual rights.
In addition to the six areas above, the NRC noted in its draft
analysis a significant qualitative benefit in the management of worker
fatigue for key personnel at nuclear power plants.
C. Screening Review for Disaggregation
The NRC also performed a screening review, consistent with Section
4.3.2 of the RA Guidelines, to determine if there are provisions
constituting backfits whose costs are disproportionate to the benefits
and whose inclusion in the aggregate analysis could obscure their
impact. The NRC identified 15 proposed backfits with reasonable
indications that the costs associated with the proposed backfit may be
disproportional to the safety benefit attributable to the change. The
NRC determined that all of the 15 proposed backfits were necessary to
meet the objectives of the rule. Therefore, the staff did not
disaggregate any of those individual provisions and perform a separate
backfit analysis for each provision. A detailed discussion of the
screening review, including the reasons why each of the 15 proposed
backfits were determined to be necessary to meet the objectives of the
proposed rule is described in Section 4.4.2 of the draft Regulatory
Analysis.
XVII. References
Akerstedt, T. (2004). Predictions from the three-process model of
alertness. Aviation, Space and Environmental Medicine, 75(3), 2,
A75-A83.
Akerstedt, T. (2003). Shift work and disturbed sleep/wakefulness.
Occupational Medicine, March;53(2):89-94.
Akerstedt, T. (1995). Work hours, sleepiness and the underlying
mechanisms. Journal of Sleep Research, 4, 15-22.
Akerstedt, T. (1995). Work injuries and time of day--national data.
Shiftwork International Newsletter, 12(1), 2.
Alluisi, E.A. and Morgan, B.B. (1982). Sustained performance. In:
E.E. Bilodeau (Ed.) Principles of Skill Acquisition. New York:
Academic Press.
Angus, R. and Heslegrave, R. (1985). Effects of sleep loss on
sustained cognitive performance during a command and control
simulation. Behavioral Research Methods, Instruments and Computers,
17, 55-67.
Baker, K., Olson, J., and Morisseau, D. (1994). Work practices,
fatigue, and nuclear power plant safety performance. Human Factors,
36(2), 244-257.
Baker, T.L., Campbell, S.C., Linder, K.D., and Moore-Ede, M. C.
(1990). Control room operator alertness and performance in nuclear
power plants. EPRI Technical Report NP-6748. CA: Palo Alto: Electric
Power Research Institute.
Baldwin, D.C. Jr. and Daugherty, S.R. (2004). Sleep deprivation and
fatigue in residency training: results of a national survey of
first- and second-year residents. Sleep, 2004 March 15;27(2):217-23.
Baldwin, D.C. Jr., Daugherty, S.R., Tsai, R. and Scotti, M.J. Jr.
(2003). A national survey of residents' self-reported work hours:
thinking beyond specialty. Academic Medicine, Nov;78(11):1154-63.
Balkin, T., Thorne, D., Sing, H., Thomas, M., Redmond, D.,
Wesensten, N., Russo, M., Williams, J., Hall, S., and Belenky, G.
(2000). Effects of sleep schedules on commercial motor vehicle
driver performance. U.S. DOT Technical Report No. DOT-MC-00-113.
Washington, DC: Department of Transportation Federal Motor Carrier
Safety Administration.
Banderet, L.E., Stokes, J., Francesconi, R., Kowal, D. and Naitoh,
P. (1981). Artillery teams in simulated sustained combat:
performance and other measures. In: L.C. Johnson, D. Tepas, W.
Colguhon, M. Colligan. Biological Rhythms, Sleep and Shift Work.
Spectrum, New York, 459-477.
Beal, J. and Rosekind, M. (Eds.) (1995). Fatigue symposium
proceedings, November 1-2, 1995. Washington, DC: National
Transportation Safety Board.
Belenky, G.L., Wesensten, N.J., Thorne, D., Thomas, M., Sing, H.,
Redmond, D. P., Russo, M. B. and Balkin, T. (2003). Patterns of
performance gradation and restoration during sleep restriction and
subsequent recovery: a sleep dose-response study. Journal of Sleep
Research, 12, 1-12.
Bobko, N., Karpenko, A., Gerasimov, A., and Chernyuk, V. (1998). The
mental performance of shiftworkers in nuclear and heat power plants
of Ukraine. In: International Journal of Industrial Ergonomics, 21,
333-340.
Bruck D. and Pisani D.L. (1999). The effects of sleep inertia on
decision-making performance. Journal of Sleep Research,
June;8(2):95-103.
Buxton, S., Hartley, L. and Krueger, G.P. (2002). The health and
safety hazards of shift work: strategies to overcome them. (Murdoch
University Technical Report). Western Australia, Australia: Murdoch
University, Institute for Research in Safety and Transport. Victoria
Roads Technical Report No. 2002-05, October, 2002; Kew, Victoria,
Australia; ISBN No. 07-7311-9076-9.
Cabon, P., Bourgeois-Bougrine, S., Mollard, R., Coblentz, A., and
Speyer, J. (2003). Electronic pilot-activity monitor: a
countermeasure against fatigue on long-haul flights. Aviation,
space, and environmental medicine, June;74(6 Pt 1):679-82.
Carrier, J. and Monk, T. (2000). Circadian rhythms of performance:
New trends. Chronobiology International, 17(6):719-732.
Carrier, J., Monk, T.H., Buysse, D., and Kupfer, D.J. (1997). Sleep
and morningness-eveningness in the ``middle'' years of life (20-59
y). Journal of Sleep Research, 6:230-237.
Carroll, R. J. (Ed.) (1999). Ocular measures of driver alertness:
technical conference proceedings, April 26-27, 1999. FHWA-MC-99-136.
Washington DC: Federal Highway Administration Office of Motor
Carrier and Highway Safety.
[[Page 50622]]
Circadian Technologies Incorporated. (2004). 2004 shiftwork
practices survey. Circadian Information, 125 Cambridge Park Drive,
Cambridge MA.
Circadian Technologies Incorporated. (2003). Overtime in extended
hours operations: benefits, costs, risks and liabilities. Circadian
Information, 125 Cambridge Park Drive, Cambridge MA.
Circadian Technologies Incorporated. (2000). Shiftwork practices
2000: A summary of the annual managing 24x7 survey of 24-hour
operations. Circadian Information, 125 Cambridge Park Drive,
Cambridge MA.
Colquhoun, W., Costa, G., Folkard, S. and Knauth, P. (1996).
Shiftwork problems and solutions. Frankfurt am Main: Peter Lang
GmbhH.
Comperatore, C.A. and Krueger, G.P. (1990). Circadian rhythm
desynchronosis, jet lag, shift lag, and coping strategies. In:
Occupational Medicine: State of the Art Reviews, 1990, Vol. 5, No.
2, pg. 323-341, Philadelphia, PA: Hanley and Belfus, Inc. (1990).
Also as USAARL Technical Report No. 90-14. Fort Rucker, AL: U.S.
Army Aeromedical Research Laboratory, September 1990. (DTIC No. AD:
A228-787).
Council Directive. (1993). 93/104/EC of 23 November 1993 concerning
certain aspects of the organization of working time, Official
Journal of the European Communities L 307, 13/12/1993 P. 0018-00241.
Dawson D. and Campbell, S. (1991). Timed exposure to bright light
improves sleep and alertness during simulated night shifts. Sleep,
Dec;14(6):511-6.
Dawson, D. and Reid, K. (1997). Fatigue, alcohol and performance
impairment. Nature, 388:235.
Department of Health and Human Services, Substance Abuse and Mental
Health Services Administration, ``Guidance for Reporting Specimen
Validity Test Results,'' Program Document 35, September 28, 1998.
Dinges, D.F., Pack, F., Williams, K., Gillen, K.A., Powell, J.W.,
Ott, G.E., Aptowicz, C. and Pack, A.I. (1997). Cumulative
sleepiness, mood disturbance, and psychomotor vigilance performance
decrements during a week of sleep restricted to 4-5 hours per night.
Sleep, 20:4, pp. 267-277.
Dinges, D.F. (1995). An overview of sleepiness and accidents.
Journal of Sleep Research, 4, 4-14.
Dinges, D.F. (1992). Probing the limits of functional capability:
The effects of sleep loss on short-duration tasks. In: R.J.
Broughton and R. Ogilvie (Eds.) Sleep, Arousal and Performance.
Boston: Birkhauser--Boston, Inc.
Dinges, D. F., Whitehouse, W. G., Orne, E. C. and Orne, M. T.
(1988). The benefits of a nap during prolonged work and wakefulness.
Work and Stress, 2:139-153.
Doran, S., Van Dongen, H., and Dinges, D.F. (2001). Sustained
attention performance during sleep deprivation: evidence of state
instability. Archive Itialiennes de Biologic.
Dorel, M., (1996). Human failure in the control of nuclear power
stations: temporal logic of occurrence and alternating work times.
In: Stanton, N., Human Factors in Nuclear Safety, London, Taylor &
Francis Ltd.
Falleti, M.G., Maruff, P., Collie, A., Darby, D.G. and McStephen, M.
(2003). Qualitative similarities in cognitive impairment associated
with 24h of sustained wakefulness and blood alcohol concentration of
0.05%. Journal of Sleep Research, Dec;12(4):265-74.
Folkard S., and Tucker P. (2003). Shift work, safety and
productivity. Journal of Occupational Medicine, Mar;53(2):95-101.
Folkard, S. (1997). Black times: temporal determinants of transport
safety. Accident Analysis and Prevention, 29, 417-430.
Folkard S., Akerstedt T. (1992). A three-process model of the
regulation of alertness-sleepiness. In: Broughton R.J., Ogilvie
R.D., (eds.) Sleep, arousal, and performance: a tribute to Bob
Wilkinson. Boston: Birkhauser; 1992, 11-26.
Gander, P., Gregory, K., Miller, D., Graeber, R., Connell, L., and
Rosekind, M. (1998). Crew factors in flight operations: the initial
NASA-Ames field studies on fatigue. Aviation, Space, and
Environmental Medicine, Vol. 69 (No. 9, Section II, Supplement).
Hanecke, K., Tiedemann, S., Nachreiner, F. and Grzech-Sukalo, H.
(1998). Accident risk as a function of time on task and time of day.
Shiftwork International Newsletter. 14(1) Abstracts from the XII
International Symposium on Night and Shiftwork New Challenges for
the Organization, June 23-27, 1997, Majvik, Finland.
Harrison, Y. and Horne, J.A. (2000). The impact of sleep deprivation
on decision making: a review. Journal of Experimental Psychology:
Applied, 6(3), 236-249.
Harrison, Y. and Horne, J.A. (1998). Sleep loss impairs short and
novel language tasks having a prefrontal focus. Journal of Sleep
Research, 7:95-100.
Harrison, Y. and Horne, J.A. (1997). Sleep deprivation affects
speech. Sleep. 20:871-877.
Hartley, L. (1998). Managing fatigue in transportation: Proceedings
of the 3rd Fatigue in Transportation Conference. Australia:
Femantle, Western Australia: Murdoch University Institute for
Research in Safety and Transport. Oxford, United Kingdom: Elsevier
Science, Ltd.
Hockey, G. (1970). Changes in attention allocation in a multi-
component task under sleep deprivation. British Journal of
Psychology, 61, 473-480.
Horne, J. (1988). Why We Sleep: The Functions of Sleep in Humans and
Other Mammals. New York: Oxford University Press.
Horne, J. (1988). Sleep loss and ``divergent'' thinking ability.
Sleep, December;11(6):528-36.
Jansen, N., Amelsvoort, L., Kristensen, T., Brandt, P., and Kant, I.
(2003). Work schedules and fatigue: a prospective cohort study.
Occupational and Environmental Medicine; 60 (Suppl 1): i47-i53.
Kecklund, G., Akerstedt, T., Gillberg, M., and Lowden, A. (1997).
Task, shift and sleepiness: A meta analysis. Stockholm, Sweden: IPM
and Karlinska Institute. Shiftwork International Newsletter
14(1),36.
Kemper, M. (2001). The role and effectiveness of napping on the work
performances of shift workers. Work, 16(2):153-157.
Knauth P., and Hornberger S. (2003). Preventive and compensatory
measures for shift workers. Occupational Medicine, 2003
Mar;53(2):109-16.
Krueger, G.P. (1994). Fatigue, performance, and medical error.
Chapter 14, 311-326. In: M.S. Bogner (Ed.), Human Error in Medicine.
Northvale, NJ: Erlbaum Associates.
Krueger, G.P. (1991). Sustained military performance in continuous
operations: Combatant fatigue, rest and sleep needs. Pp. 255-277.
Chapter 14 in R. Gal and A. D. Mangelsdorff (Eds.) Handbook of
Military Psychology (1991). Chichester, UK: Wiley and Sons. Also as
USAARL Technical Report No. 91-19, U.S. Army Aeromedical Research
Laboratory, Fort Rucker, AL, September, 1991. (DTIC No. AD: A242-
507).
Krueger, G.P. (1989). Sustained work, fatigue, sleep loss and
performance: A review of the issues. Work and Stress, 1989, 3(2)
129-141. (Also as USAARL Tech Rep 89-22). Fort Rucker, AL: U.S. Army
Aeromedical Research Laboratory, September 1989. (DTIC No. AD: A215-
234).
Kryger, M.H., Roth, T., and Dement, W.C. (Eds.) (1994). Principles
and practice of sleep medicine. Philadelphia, PA: W.B. Saunders.
Landrigan, C.P., Rothschild, J.M., Cronin, J.W., Kaushal, R.,
Burdick, E., Katz, J.T., Lilly, C.M., Stone, P.H., Lockley, S.W.,
Bates, D.W. and Czeisler, C.A. (2004). Effect of reducing interns'
work hours on serious medical errors in intensive care units. New
England Journal of Medicine, October 28, 2004, v351, n18, p1838-
1848.
Liskowsky, D.R. (Ed.) (1991). Biological rhythms: Implications for
the worker. OTA-BA-463. Washington, DC: U.S. Congress Office of
Technology Assessment. (ISBN 0-16-035497-8).
Lockley, S.W., Cronin, J.W., Evans, E.E., Cade, B.E., Lee, C.J.,
Landrigen, C.P., Rothschild, J.M., Katz, J.T., Lilly, C.M., Stone,
P.H., Aeschbach, D. and Czeisler, C.A. (2004). Effect of reducing
interns' weekly work hours on sleep and attentional failures. New
England Journal of Medicine, October 28, 2004, v351, n18, p1829-
1837.
Lorist, M., Klein, M., Nieuwenhuis, S., De Jong, R., Mulder, G., and
Meijman T. (2000). Mental fatigue and task control: planning and
preparation. Psychophysiology, September;37(5):614-25.
Mallis, M., Mejdal, S., Nguyen, T., and Dinges, D. (2002). Summary
of the key features of seven biomathematical models of human fatigue
and performance. Aviation, Space, and Environmental Medicine, Vol.
75 (No. 3, Section II, Supplement).
Maloney, S. (1992). Evidence of circadian and extended shift effects
on reactor transient frequency. In Transactions of the American
Nuclear Society 1992 Annual Meeting, 65: 512-513.
[[Page 50623]]
McCallum, M., Sandquist, T., Mitler, M., and Krueger, G.P. (2003).
Commercial transportation operator fatigue management reference. (US
DOT Technical Report). Washington, DC: U.S. Department of
Transportation Research and Special Programs Administration.
[Seattle, WA: Battelle Transportation Research Center, Technical
Report: OTA Mp/ DTRS56-01-T-003; July 2003].
Miller, J.C. and Mitler, M.M. (1997). Predicting accident times.
Ergonomics in Design, 5, 13-18.
Mitler, M.M. and Miller, J.C. (1996). Methods of testing for
sleepiness. Behavioral Medicine, 21, 171-183.
Monk, T.H. and Carrier, J. (2003). Shift worker performance. Clinics
in Occupational and Environmental Medicine, 2, 209-229.
Monk, T.H. (2000). What can the chronobiologist do to help the shift
worker? Journal of Biological Rhythms, 2000; 15: 86-94.
Monk, T.H., Buysse, D.J., Rose, L.R., Hall, J.A., Kupfer, D.J.
(2000). The sleep of healthy people--a diary study. Chronobiology
International, 2000 Jan;17(1):49-60.
Monk, T.H., Moline, M.L., Graeber, R.C. (1988). Inducing jet lag in
the laboratory: patterns of adjustment to an acute shift in routine.
Aviat Space Environ Med. 1988 Aug;59(8):703-10.
Monk, T. and Folkard, S., (1985). Individual differences in shift
work adjustment. In: Hours of Work--Temporal Factors in Work
Scheduling. John Wiley and Sons, Chichester and New York, 227-237.
Morgan, B.B., Brown, B. R. and Alluisi, E.A. (1974). Effects on
sustained performance of 48 hours of continuous work and sleep loss.
Human Factors, 16, 406-414.
National Center on Sleep Disorders Research (NCSDR) and the National
Highway Traffic Safety Administration, (1999). Drowsy Driving and
Automobile Crashes.
National Sleep Foundation (2003). Sleep in America Poll: 2003.
Washington DC, http://www.sleepfoundation.org/polls/2003SleepPollExecSumm.pdf.
National Sleep Foundation (2000). Sleep in America Poll: 2000.
Washington DC, http://www.sleepfoundation.org/publications/2000poll.cfm.
National Transportation Safety Board (1999). Evaluation of U.S.
Department of Transportation efforts in the 1990s to address
operator fatigue. NTSB Safety Report No. SR-99-01, May 1999.
Washington, DC: National Transportation Safety Board. PB99-917002.
National Transportation Safety Board (1994). A Review of Flightcrew-
Involved Major Accidents of U.S. Air Carriers--1978 through 1990.
NTSB Report No. SS-94-01/PB94-917001. Washington, DC, 1994.
Pascoe, P., Rogers, A. and Spencer, M. (1995). Task loading and the
development of fatigue at different times of day. Shiftwork
International Newsletter, 12(12):49.
Petrie K.J., Powell D. and Broadbent E. (2004). Fatigue self-
management strategies and reported fatigue in international pilots.
Ergonomics, April 15;47(5):461-8.
Pilcher J.J. and Huffcutt A.I. (1996). Effects of sleep deprivation
on performance: a meta-analysis. Sleep, May;19(4):318-26.
Pratt, S. (2003). Work-related roadway crashes--challenges and
opportunities for prevention. The National Institute for
Occupational Safety and Health Publication No. 2003-119.
Presser, H. (2000). Nonstandard work schedules and marital
instability. Journal of Marriage and the Family, 62, Feb: 93-110.
Priest, D. (2000). War and Sleep. The Washington Post. Washington,
DC. November 19, 2000, W17.
Priest B., Brichard C., Aubert G., Liistro G. and Rodenstein D.
(2001). Microsleep during a simplified maintenance of wakefulness
test. A validation study of the OSLER test. American journal of
respiratory and critical care medicine, June;163(7):1619-25.
Rogers, W.C. (Ed.). (1997). International conference on managing
fatigue in transportation, April 29-20, 1997. Conference
Proceedings. Alexandria, VA: American Trucking Associations. ISBN:
0-86587-516-2.
Rogers, W.C. (1996). Technical conference on enhancing commercial
motor vehicle driver vigilance, December 10-11, 1996. Conference
proceedings. Alexandria, VA: American Trucking Associations
Foundation.
Rosa R.R., Harma M., Pulli K., Mulder M. and Nasman O. (1996).
Rescheduling a three shift system at a steel rolling mill: effects
of a one hour delay of shift starting times on sleep and alertness
in younger and older workers. Occupational and Environmental
Medicine, Oct; 53(10):677-85.
Rosa, R. (1995). Extended workshifts and excessive fatigue. Journal
of Sleep Research, 4(2), 51-56.
Rosa, R. (1991). Performance, alertness, and sleep after 3.5 years
of 12 h shifts: A follow-up study. Work and Stress, 5, 107--116.
Rosekind, M., Neri, D., and Dinges, D. (1997). Fatigue and duty time
limitations--an international review proceedings. The Royal
Aeronautical Society. 7, 1-14. ISBN 1 85768 088 X.
Rosekind, M.R., Smith R.M., Miller, D.L., Co E.l., Gregory K.B.,
Webbon L.L., Gander, P.H. and Lebacqz, J.V. (1995). Fatigue self-
management strategies and reported fatigue in international pilots.
Journal of Sleep Research, Dec; 4(S2):62-66.
Rosekind M.R., Gander P.H., Miller D.L., Gregory K.B., Smith R.M.,
Weldon K.J., Co E.L., McNally K.L. and Lebacqz J.V. (1994). Fatigue
in operational settings: examples from the aviation environment.
Human Factors, 1994 Jun; 36(2):327-38.
Sallinen, M., Harma, M., Akerstedt, T., Rosa, R. and Lillqvist O.
(1998). Promoting alertness with a short nap during a night shift.
Journal of Sleep Research, 7, 240-247.
Schellekens, J., Sijtsma, G.J., Vegter, E. and Meijman, T.F. (2000).
Immediate and delayed after-effects of long lasting mentally
demanding work. Biological Psychology, Vol. 53, No. 1, May 1,
2000:37-56.
Scott, A. (1990). Shiftwork. Occupational Medicine: State of the Art
Reviews, 1990, Vol. 5, No. 2. Philadelphia, PA: Hanley and Belfus,
Inc.
Strollo P.J. Jr., Rogers R.M. (1996). Obstructive sleep apnea. New
England Journal of Medicine. 334:99-104.
Summala H., Hakkanen H, Mikkola T, and Sinkkonen J. (1999). Task
effects on fatigue symptoms in overnight driving. Ergonomics,
June;42(6):798-806.
Tepas, D. and Monk, T.H. (1987). Work schedules. In: G. Salvendy.
Handbook of Human Factors. John Wiley and Sons. 819-894.
Thomas, M. et al. (2000). Neural basis of alertness and cognitive
performance impairments during sleepiness. In: Effects of 24 h of
sleep deprivation on waking human regional brain activity. Journal
of Sleep Research. December; 9(4) 335.
Totterdell, P., Spelten, E., Smith, L., Barton, J. and Folkard, S.
(1995). Recovery from work shifts: how long does it take? The
Journal of Applied Psychology, February; 80(1):43-57.
Tucker, P., Smith, L., Macdonald, I., and Folkard, S. (1999).
Distribution of rest days in 12-hour shift systems: Impacts on
health, wellbeing, and on shift alertness. Occupational and
Environmental Medicine, 56, 206-214.
U.S. Department of Transportation. (1995). Sharing the knowledge:
Department of Transportation Focus on Fatigue. (Program Description
Pamphlet). Washington, DC: U.S. Department of Transportation.
U.S. Nuclear Regulatory Commission, ``Criteria for Preparation and
Evaluation of Radiological Emergency Response Plans and Preparedness
in Support of Nuclear Power Plants,'' NUREG-0654, Rev. 1, March
2002.
U.S. Nuclear Regulatory Commission, ``Accident Source Terms for
Light-Water Nuclear Power Plants,'' NUREG-1465, February 1995.
U.S. Nuclear Regulatory Commission, ``Fitness for Duty in the
Nuclear Power Industry: Responses to Implementation Questions,''
NUREG-1385, October 1989.
U.S. Nuclear Regulatory Commission, ``Fitness for Duty in the
Nuclear Power Industry: Responses to Public Comments,'' NUREG-1354,
May 1989.
U.S. Nuclear Regulatory Commission, ``The Human Performance
Evaluation Process: A Resource for Reviewing the Identification and
Resolution of Human Performance Problems,'' NUREG/CR-6751, April
2002.
U.S. Nuclear Regulatory Commission, ``Review of Findings for Human
Error Contribution to Risk in Operating Events,'' NUREG/CR-6753,
August 2001.
U.S. Nuclear Regulatory Commission, ``Recommendations for NRC Policy
on Shift Scheduling and Overtime at Nuclear Power Plants,'' NUREG/
CR-4248, July 1985.
U.S. Nuclear Regulatory Commission, ``Handbook on Human Reliability
Analysis with Emphasis on Nuclear Power Plant Applications,'' NUREG/
CR-1278, August 1983.
Van der Linden, D., Frese, M. and Sonnentag, S. (2003). The impact
of mental fatigue on
[[Page 50624]]
exploration in a complex computer task: Rigidity and loss of
systematic strategies. Human Factors, 45:483-494.
Van Dongen, H.P., Maynard, M.D., Maislin, G. and Dinges, D.F.
(2004a). Systematic interindividual differences in neurobehavioral
impairment from sleep loss: evidence of trait-like differential
vulnerability. Sleep, 2004 May 1:27(3):423-33.
Van Dongen, H.P., Maislin, G. and Dinges, D.F. (2004b). Dealing with
inter-individual differences in temporal dynamics of fatigue and
performance: importance and techniques. Aviation Space and
Environmental Medicine, 2004 March;75(3 Suppl.):A147-54.
Van Dongen, H., Maislin, G., Mullington, J. and Dinges, D. (2003).
The cumulative cost of additional wakefulness: dose-response effects
on neurobehavioral functions and sleep physiology from chronic sleep
restriction and total sleep deprivation. Sleep, March 15; 26(2):117-
26.
Webb, W.B. and Agnew, H.W. (1974). The effects of a chronic
limitation of sleep length. Psychophysiology, 11, 265-274.
Williams, H.L., Lubin, A. and Goodnow, J.J. (1959). Impaired
performance with acute sleep loss. Psychological Monographs, No.
484, 73, 1-26.
Williamson, A.M. and Feyer, A. (2000). Moderate sleep deprivation
produces impairments in cognitive and motor performance equivalent
to legally prescribed levels of alcohol intoxication. Occupational
and Environmental Medicine, 57, 649-655.
Wu, J.C., Gillin, J.C., Buchsbaum, M.S., Hershey, T., Hazlett, E.,
Sicotte, N. and Bunney, W.E. (1991). The effect of sleep deprivation
on cerebral glucose metabolic rate in normal humans assessed with
positron emission tomography. Sleep, 156:1149-1158.
Copies of publicly available reference items are available for
inspection and/or copying for a fee in the NRC Public Document Room,
One White Flint North, 11555 Rockville Pike, Room O-F21, Rockville,
MD 20852-2738. Copyrighted materials may be viewed at the NRC Public
Document Room, but may not be copied.
List of Subjects in 10 CFR Part 26
Alcohol abuse, Alcohol testing, Appeals, Chemical testing, Drug
abuse, Drug testing, Employee assistance programs, Fitness for duty,
Management actions, Nuclear power reactors, Protection of information,
Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to
revise 10 CFR Part 26 in its entirety to read as follows:
PART 26--FITNESS FOR DUTY PROGRAMS
Subpart A--Administrative Provisions
Sec.
26.1 Purpose.
26.3 Scope.
26.5 Definitions.
26.7 Interpretations.
26.8 Information collection requirements: OMB approval.
26.9 Specific exemptions.
26.11 Communications.
Subpart B--Program Elements
26.21 Fitness-for-duty program.
26.23 Performance objectives.
26.25 Individuals subject to the fitness-for-duty program.
26.27 Written policy and procedures.
26.29 Training.
26.31 Drug and alcohol testing.
26.33 Behavioral observation.
26.35 Employee assistance programs.
26.37 Protection of information.
26.39 Review process for fitness-for-duty policy violations.
26.41 Audits and corrective action.
Subpart C--Granting and Maintaining Authorization
26.51 Purpose.
26.53 General provisions.
26.55 Initial authorization.
26.57 Authorization update.
26.59 Authorization reinstatement.
26.61 Self-disclosure and employment history.
26.63 Suitable inquiry.
26.65 Pre-access drug and alcohol testing.
26.67 Random drug and alcohol testing of individuals who have
applied for authorization.
26.69 Authorization with potentially disqualifying fitness-for-duty
information.
26.71 Maintaining authorization.
Subpart D--Management Actions and Sanctions To Be Imposed
26.75 Sanctions.
26.77 Management actions regarding possible impairment.
Subpart E--Collecting Specimens for Testing
26.81 Purpose.
26.83 Specimens to be collected.
26.85 Collector qualifications and responsibilities.
26.87 Collection sites.
26.89 Preparing to collect specimens for testing.
26.91 Acceptable devices for conducting initial and confirmatory
tests for alcohol and methods of use.
26.93 Preparing for alcohol testing.
26.95 Conducting an initial test for alcohol using a breath
specimen.
26.97 Conducting an initial test for alcohol using a specimen of
oral fluids.
26.99 Determining the need for a confirmatory test for alcohol.
26.101 Conducting a confirmatory test for alcohol.
26.103 Determining a confirmed positive test result for alcohol.
26.105 Preparing for urine collection.
26.107 Collecting a urine specimen.
26.109 Urine specimen quantity.
26.111 Checking the validity of the urine specimen.
26.113 Splitting the urine specimen.
26.115 Collecting a urine specimen under direct observation.
26.117 Preparing urine specimens for storage and shipping.
26.119 Determining ``shy'' bladder.
Subpart F--Licensee Testing Facilities
26.121 Purpose.
26.123 Testing facility capabilities.
26.125 Licensee testing facility personnel.
26.127 Procedures.
26.129 Assuring specimen security, chain of custody, and
preservation.
26.131 Cutoff levels for validity screening and initial validity
tests.
26.133 Cutoff levels for drugs and drug metabolites.
26.135 Split specimens.
26.137 Quality assurance and quality control.
26.139 Reporting initial validity and drug test results.
Subpart G--Laboratories Certified by the Department of Health and Human
Services
26.151 Purpose.
26.153 Using certified laboratories for testing urine specimens.
26.155 Laboratory personnel.
26.157 Procedures.
26.159 Assuring specimen security, chain of custody, and
preservation.
26.161 Cutoff levels for validity testing.
26.163 Cutoff levels for drugs and drug metabolites.
26.165 Testing split specimens and retesting single specimens.
26.167 Quality assurance and quality control.
26.169 Reporting results.
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
26.181 Purpose.
26.183 Medical review officer.
26.185 Determining a fitness-for-duty policy violation.
26.187 Substance abuse expert.
26.189 Determination of fitness.
Subpart I--Managing Fatigue
26.195 Applicability.
26.197 General provisions.
26.199 Work hour controls.
26.201 Fatigue assessments.
Subpart J--Recordkeeping and Reporting Requirements
26.211 General provisions.
26.213 Recordkeeping requirements for licensees and other entities.
26.215 Recordkeeping requirements for collection sites, licensee
testing facilities, and laboratories certified by the Department of
Health and Human Services.
26.217 Fitness-for-duty program performance data.
26.219 Reporting requirements.
Subpart K--Inspections, Violations, and Penalties
26.221 Inspections.
26.223 Violations.
26.225 Criminal penalties.
[[Page 50625]]
Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935,
936, 937, 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42
U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201, 2297f); secs. 201,
202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C. 5841,
5842, 5846).
Subpart A--Administrative Provisions
Sec. 26.1 Purpose.
This part prescribes requirements and standards for the
establishment, implementation, and maintenance of fitness-for-duty
(FFD) programs.
Sec. 26.3 Scope.
(a) The regulations in this part apply to licensees who are
authorized to operate a nuclear power reactor (under Sec. 50.57 of
this chapter) and holders of a combined license after the Commission
has made the finding under Sec. 52.103 of this chapter.
(b) The regulations in this part, except those contained in Subpart
I, also apply to licensees who are authorized to possess, use, or
transport formula quantities of strategic special nuclear material
(SSNM) under Part 70 of this chapter.
(c) In addition, the regulations in this part, except those
contained in Subpart I, apply to a corporation, firm, partnership,
limited liability company, association, or other organization that
obtains a certificate of compliance or an approved compliance plan
under Part 76 of this chapter, only if the entity elects to engage in
activities involving formula quantities of SSNM. When applicable, the
requirements apply only to the entity and personnel specified in Sec.
26.25(a)(3).
(d) The regulations in this part also apply to contractor/vendors
(C/Vs) who implement FFD programs or program elements, to the extent
that licensees and other entities rely upon those C/V FFD programs or
program elements to meet the requirements of this part.
(e) Combined license holders (under Part 52 of this chapter) before
the Commission has made the finding under Sec. 52.103 of this chapter,
combined license applicants who have received authorization to
construct under Sec. 50.10(e)(3), construction permit holders (under
Part 50 of this chapter), construction permit applicants who have
received authorization to construct under Sec. 50.10(e)(3), and
holders of manufacturing licenses (under Part 52 of this chapter)
shall--
(1) Comply with Sec. Sec. 26.23, 26.41, and 26.189;
(2) Implement a drug and alcohol testing program, including random
testing; and
(3) Make provisions for employee assistance programs, imposition of
sanctions, procedures for the objective and impartial review of
authorization decisions, protection of information, and recordkeeping.
(f) The regulations in this part do not apply to either spent fuel
storage facility licensees or non-power reactor licensees who possess,
use, or transport formula quantities of irradiated SSNM because these
materials are exempt from the Category I physical protection
requirements set forth in 10 CFR 73.6.
Sec. 26.5 Definitions.
Acute fatigue means fatigue from causes (e.g., restricted sleep,
sustained wakefulness, task demands) occurring within the past 24
hours.
Adulterated specimen means a urine specimen that contains a
substance that is not a normal constituent, or one that contains an
endogenous substance at a concentration that is not a normal
physiological concentration.
Alertness means the ability to remain awake and sustain attention.
Aliquot means a portion of a specimen that is used for testing. It
is taken as a sample representing the whole specimen.
Analytical run means the process of testing a group of urine
specimens for validity or for the presence of drugs and/or drug
metabolites. For the purposes of defining the periods within which
performance testing must be conducted by licensee testing facilities
and HHS-certified laboratories who continuously process specimens, an
analytical run is defined as no more than an 8-hour period. For a
facility that analyzes specimens in batches, an analytical run is
defined as a group of specimens that are handled and tested together.
Best effort means documented actions that a licensee or other
entity who is subject to this part takes to obtain suitable inquiry and
employment information in order to determine whether an individual may
be authorized to have the types of access or to perform the activities
specified in Sec. 26.25(a), when the primary source of information
refuses or indicates an inability or unwillingness to provide the
information within 3 business days of the request and the licensee or
other entity relies upon a secondary source to meet the requirement.
Blood alcohol concentration (BAC) means the mass of alcohol in a
volume of blood.
Calibrator means a solution of known concentration which is used to
define expected outcomes of a measurement procedure or to compare the
response obtained with the response of a test specimen/sample. The
concentration of the analyte of interest in the calibrator is known
within limits ascertained during its preparation. Calibrators may be
used to establish a cutoff concentration and/or a calibration curve
over a range of interest.
Category IA material means SSNM that is directly usable in the
manufacture of a nuclear explosive device, except if the material meets
any of the following criteria:
(1) The dimensions are large enough (at least 2 meters in one
dimension, greater than 1 meter in each of two dimensions, or greater
than 25 cm in each of three dimensions) to preclude hiding the item on
an individual;
(2) The total weight of an encapsulated item of SSNM is such that
it cannot be carried inconspicuously by one person (i.e., at least 50
kilograms gross weight); or
(3) The quantity of SSNM (less than 0.05 formula kilograms) in each
container requires protracted diversions to accumulate 5 formula
kilograms.
Chain of custody means procedures to account for the integrity of
each specimen or aliquot by tracking its handling and storage from the
point of specimen collection to final disposition of the specimen and
its aliquots. ``Chain of custody'' and ``custody and control'' are
synonymous and may be used interchangeably.
Circadian variation in alertness and performance means the
increases and decreases in alertness and cognitive/motor functioning
caused by human physiological processes (e.g., body temperature,
release of hormones) that vary on an approximately 24-hour cycle.
Collection site means a designated place where individuals present
themselves for the purpose of providing a specimen of their urine, oral
fluids, and/or breath to be analyzed for the presence of drugs or
alcohol.
Collector means a person who is trained in the collection
procedures of this part, instructs and assists a specimen donor at a
collection site, and receives and makes an initial examination of the
specimen(s) provided by the donor.
Commission means the U.S. Nuclear Regulatory Commission or its duly
authorized representatives.
Confirmatory drug or alcohol test means a second analytical
procedure to identify the presence of alcohol or a specific drug or
drug metabolite in a specimen. The purpose of a confirmatory test is to
ensure the reliability and accuracy of an initial test result.
[[Page 50626]]
Confirmatory validity test means a second test performed on a
different aliquot of the original urine specimen to further support a
validity test result.
Confirmed test result means a test result that demonstrates that an
individual has used drugs or alcohol in violation of the requirements
of this part or has attempted to subvert the testing process by
submitting an adulterated or substituted urine specimen. For drugs,
adulterants, and substituted specimens, a confirmed test result is
determined by the Medical Review Officer (MRO), after discussion with
the donor subsequent to the MRO's receipt of a positive confirmatory
drug test result from the HHS-certified laboratory and/or a non-
negative confirmatory validity test result from the HHS-certified
laboratory for that donor. For alcohol, a confirmed test result is
based upon a positive confirmatory alcohol test result from an
evidential breath testing device without MRO review of the test result.
Contractor/vendor (C/V) means any company, or any individual not
employed by a licensee or other entity who is subject to this part, who
is providing work or services to a licensee or other entity subject to
this part, either by contract, purchase order, verbal agreement, or
other arrangement.
Control means a sample used to monitor the status of an analysis to
maintain its performance within predefined limits.
Cumulative fatigue means the increase in fatigue over consecutive
sleep-wake periods resulting from inadequate rest.
Cutoff level means the concentration established for designating
and reporting a test result as non-negative.
Dilute specimen means a urine specimen with creatinine and specific
gravity concentrations that are lower than expected for human urine.
Directing means the exercise of control over a work activity by an
individual who is directly involved, capable of making technical
decisions, and ultimately responsible for the correct performance of
that work activity.
Donor means the individual from whom a specimen is collected.
Employment action means a change in job responsibilities or removal
from a job, or the mandated implementation of a plan for substance
abuse treatment in order to avoid a change in or removal from a job,
because of the individual's use of drugs or alcohol.
Fatigue means the degradation in an individual's cognitive and
motor functioning resulting from inadequate rest.
Formula quantity means strategic special nuclear material in any
combination in a quantity of 5000 grams or more computed by the
formula, grams=(grams contained U-235)+2.5 (grams U-233+grams
plutonium). This class of material is sometimes referred to as a
Category I quantity of material.
HHS-certified laboratory means a laboratory that is certified to
perform urine drug testing under the most recent version of the
Department of Health and Human Services Mandatory Guidelines for
Federal Workplace Drug Testing Programs. Information concerning the
current certification status of laboratories is available from: the
Division of Workplace Programs, Center for Substance Abuse Prevention,
Substance Abuse and Mental Health Services Administration, Room 815,
5600 Fishers Lane, Rockwall 2 Bldg., Rockville, Maryland 20857.
Illegal drug means, for the purposes of this regulation, any drug
that is included in Schedules I-V of section 202 of the Controlled
Substances Act [21 U.S.C. 812], but not when used pursuant to a valid
prescription or when used as otherwise authorized by law.
Increase in threat condition means an increase in the protective
measure level as promulgated by an NRC Advisory.
Initial drug test means a test to differentiate ``negative''
specimens from those that require confirmatory drug testing.
Initial validity test means a first test used to determine whether
a specimen is adulterated, diluted, or substituted, and may require
confirmatory validity testing.
Invalid result means the result reported by an HHS-certified
laboratory for a specimen that contains an unidentified adulterant,
contains an unidentified interfering substance, has an abnormal
physical characteristic, contains inconsistent physiological
constituents, or has an endogenous substance at an abnormal
concentration that prevents the laboratory from completing testing or
obtaining a valid drug test result.
Legal action means a formal action taken by a law enforcement
authority or court of law, including an arrest, an indictment, the
filing of charges, a conviction, or the mandated implementation of a
plan for substance abuse treatment in order to avoid a permanent record
of an arrest or conviction, in response to any of the following
activities:
(1) The use, sale, or possession of illegal drugs;
(2) The abuse of legal drugs or alcohol; or
(3) The refusal to take a drug or alcohol test.
Licensee testing facility means a drug testing facility that is
operated by a licensee or other entity who is subject to this part to
perform initial tests of urine specimens.
Limit of detection (LOD) means the lowest concentration of an
analyte that an analytical procedure can reliably detect, which could
be significantly lower than the established cutoff levels.
Limit of quantitation (LOQ) means the lowest concentration of an
analyte at which the concentration of the analyte can be accurately
determined under defined conditions.
Medical Review Officer (MRO) means a licensed physician who is
responsible for receiving laboratory results generated by a Part 26
drug testing program and who has the appropriate medical training to
properly interpret and evaluate an individual's non-negative test
results together with his or her medical history and any other relevant
biomedical information.
Nominal means the limited flexibility that is permitted in meeting
a scheduled due date for completing a recurrent activity that is
required under this part, such as the nominal 12-month frequency
required for FFD refresher training in Sec. 26.29(c)(2) and the
nominal 12-month frequency required for certain audits in Sec.
26.41(c)(1). Completing a recurrent activity at a nominal frequency
means that the activity may be completed within a period that is 25
percent longer or shorter than the period required in this part. The
next scheduled due date would be no later than the current scheduled
due date plus the required frequency for completing the activity.
Non-negative test result means a report by the licensee testing
facility or the HHS-certified laboratory that a urine specimen meets
the criteria for substitution established in this part or is positive
for a drug, drug metabolite, or adulterant at a concentration equal to
or greater than the designated cutoff levels, or the results of a test
of oral fluids or breath that indicate the presence of alcohol at a
concentration equal to or greater than the cutoff levels established by
the FFD program or as specified in this part. A non-negative test
result may be obtained from any initial or confirmatory drug, validity,
or alcohol test.
Other entity means any corporation, firm, partnership, limited
liability company, association, C/V, or other organization who is
subject to this part under Sec. 26.3(c) and (d), but is not licensed
by the NRC.
[[Page 50627]]
Oxidizing adulterant means a substance that acts alone or in
combination with other substances to oxidize drugs or drug metabolites
to prevent the detection of the drugs or drug metabolites, or a
substance that affects the reagents in either the initial or
confirmatory drug test. Examples of these agents include, but are not
limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach,
iodine/iodide, halogens, peroxidase, and peroxide.
Potentially disqualifying FFD information means information
demonstrating that an individual has--
(1) Violated a licensee's or other entity's FFD policy;
(2) Had authorization denied or terminated unfavorably under
Sec. Sec. 26.61(d), 26.63(d), 26.65(h), 26.67(c), 26.69(f), or
26.75(b) through (e);
(3) Used, sold, or possessed illegal drugs;
(4) Abused legal drugs or alcohol;
(5) Subverted or attempted to subvert a drug or alcohol testing
program;
(6) Refused to take a drug or alcohol test;
(7) Been subjected to a plan for substance abuse treatment (except
for self-referral); or
(8) Had legal action or employment action, as defined in this
section, taken for alcohol or drug use.
Protected area has the same meaning as in Sec. 73.2(g) of this
chapter, an area encompassed by physical barriers and to which access
is controlled.
Quality control sample means a sample used to evaluate whether an
analytical procedure is operating within predefined tolerance limits.
Calibrators, controls, negative samples, and blind samples are
collectively referred to as ``quality control samples'' and each is
individually referred to as a ``sample.''
Reviewing official means the designated licensee or other entity's
employee who is responsible for reviewing and evaluating any
potentially disqualifying FFD information about an individual,
including, but not limited to, the results of a determination of
fitness, as defined in Sec. 26.189, in order to determine whether the
individual may be granted or maintain authorization.
Standard means a reference material of known purity or a solution
containing a reference material at a known concentration.
Strategic special nuclear material (SSNM) means uranium-235
(contained in uranium enriched to 20 percent or more in the U-235
isotope), uranium-233, or plutonium.
Substance abuse means the use, sale, or possession of illegal
drugs, or the abuse of prescription and over-the-counter drugs, or the
abuse of alcohol.
Substituted specimen means a specimen with creatinine and specific
gravity values that are so diminished or so divergent that they are not
consistent with normal human physiology.
Subversion and subvert the testing process mean a willful act to
avoid being tested or to bring about an inaccurate drug or alcohol test
result for oneself or others at any stage of the testing process
(including selection and notification of individuals for testing,
specimen collection, specimen analysis, test result reporting), and
adulterating, substituting, or otherwise causing a specimen to provide
an inaccurate test result.
Transporter means a general licensee, under 10 CFR 70.20(a), who is
authorized to possess formula quantities of SSNM, in the regular course
of carriage for another or storage incident thereto, and includes the
driver or operator of any conveyance, and the accompanying guards or
escorts.
Validity screening test means the use of a non-instrumented testing
device to determine the need for initial validity testing of a urine
specimen.
Sec. 26.7 Interpretations.
Except as specifically authorized by the Commission in writing, no
interpretation of the meaning of the regulations in this part by any
officer or employee of the Commission other than a written
interpretation by the General Counsel will be recognized to be binding
upon the Commission.
Sec. 26.8 Information collection requirements: OMB approval.
(a) The NRC has submitted the information collection requirements
contained in this part for approval by the Office of Management and
Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). The NRC may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has approved the information
collection requirements contained in this part under control number
3150-0146.
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 26.9, 26.27, 26.29, 26.31, 26.33, 26.35,
26.37, 26.39, 26.41, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.69,
26.75, 26.77, 26.85, 26.87, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101,
26.103, 26.107, 26.109, 26.111, 26.113, 26.115, 26.117, 26.119, 26.125,
26.127, 26.129, 26.135, 26.137, 26.139, 26.153, 26.155, 26.157, 26.159,
26.163, 26.165, 26.167, 26.169, 26.183, 26.185, 26.187, 26.189, 26.197,
26.199, 26.201, 26.211, 26.213, 26.215, 26.217, 26.219, and 26.221.
Sec. 26.9 Specific exemptions.
Upon application of any interested person or upon its own
initiative, the Commission may grant such exemptions from the
requirements of the regulations in this part as it determines are
authorized by law and will not endanger life or property or the common
defense and security, and are otherwise in the public interest.
Sec. 26.11 Communications.
Except where otherwise specified in this part, all communications,
applications, and reports concerning the regulations in this part must
be sent either by mail addressed: ATTN: NRC Document Control Desk, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand
delivery to the NRC's offices at 11555 Rockville Pike, Rockville,
Maryland, between the hours of 8:15 a.m. and 4 p.m. eastern time; or,
where practicable, by electronic submission, for example, via
Electronic Information Exchange, e-mail, or CD-ROM. Electronic
submissions must be made in a manner that enables the NRC to receive,
read, authenticate, distribute, and archive the submission, and process
and retrieve it a single page at a time. Detailed guidance on making
electronic submissions can be obtained by visiting the NRC's Web site
at http://www.nrc.gov/site-help/eie.html, by calling (301) 415-6030, by
e-mail at [email protected], or by writing to the Office of Information
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001. The guidance discusses, among other topics, the formats the NRC
can accept, the use of electronic signatures, and the treatment of
nonpublic information. Copies of all communications must be sent to the
appropriate regional office and resident inspector (addresses for the
NRC Regional Offices are listed in Appendix D to Part 20 of this
chapter).
Subpart B--Program Elements
Sec. 26.21 Fitness-for-duty program.
Licensees and other entities who are subject to this part must
establish, implement, and maintain FFD programs in accordance with the
applicable requirements of this part. Fitness-for-duty programs subject
to this part may rely upon the FFD program or program elements of a C/
V, as defined in Sec. 26.5, if the C/V's FFD program or program
elements meet the applicable requirements of this part.
[[Page 50628]]
Sec. 26.23 Performance objectives.
Fitness-for-duty programs must--
(a) Provide reasonable assurance that individuals who are subject
to this part are trustworthy and reliable as demonstrated by the
avoidance of substance abuse;
(b) Provide reasonable assurance that individuals who are subject
to this part are not under the influence of any substance, legal or
illegal, or mentally or physically impaired from any cause, which in
any way adversely affects their ability to safely and competently
perform their duties;
(c) Provide reasonable measures for the early detection of
individuals who are not fit to perform the job duties that require them
to be subject to this part;
(d) Provide reasonable assurance that the workplaces subject to
this part are free from the presence and effects of illegal drugs and
alcohol; and
(e) Provide reasonable assurance that the effects of fatigue and
degraded alertness on individuals' abilities to safely and competently
perform their duties are managed commensurate with maintaining public
health and safety.
Sec. 26.25 Individuals subject to the fitness-for-duty program.
(a) Individuals whose job duties require them to have the following
types of access, or to perform the following activities are subject to
the FFD program:
(1) All persons who are granted unescorted access to nuclear power
plant protected areas;
(2) All persons who are required by a licensee to physically report
to the licensee's Technical Support Center or Emergency Operations
Facility, in accordance with licensee emergency plans and procedures;
(3) SSNM licensee and transporter personnel who--
(i) Are granted unescorted access to Category IA Material;
(ii) Create or have access to procedures or records for
safeguarding SSNM;
(iii) Measure Category IA Material;
(iv) Transport or escort Category IA Material; or
(v) Guard Category IA Material;
(4) All FFD program personnel who are involved in the day-to-day
operations of the program, as defined by the licensee's or other
entity's procedures, and who--
(i) Can link test results with the individual who was tested before
an FFD policy violation determination is made, including, but not
limited to the MRO;
(ii) Make determinations of fitness;
(iii) Make authorization decisions;
(iv) Are involved in selecting or notifying individuals for
testing; or
(v) Are involved in the collection or on-site testing of specimens.
(b) The following individuals are not subject to the FFD program:
(1) Individuals who are not employed by the licensee's or other
entity's FFD program, who do not routinely provide FFD program
services, and whose normal workplace is not at the licensee's or other
entity's facility, but who may be called upon to provide an FFD program
service, including, but not limited to, collecting specimens for drug
and alcohol testing, performing behavioral observation, or providing
input to a determination of fitness. Such individuals may include, but
are not limited to, hospital, employee assistance program (EAP) or
substance abuse treatment facility personnel, or other medical
professionals;
(2) NRC employees, law enforcement personnel, or offsite emergency
fire and medical response personnel while responding on site; and
(3) SSNM transporter personnel who are subject to U.S. Department
of Transportation drug and alcohol FFD programs that require random
testing for drugs and alcohol.
(c) Individuals who are subject to this part and who are also
subject to a program regulated by another Federal agency or State need
be covered by only those elements of a Part 26 FFD program that are not
included in the Federal agency or State program, as long as all of the
following conditions are met:
(1) The individuals are subject to pre-access (or pre-employment),
random, for-cause, and post-event testing for the drugs and drug
metabolites specified in Sec. 26.31(d)(1) at or below the cutoff
levels specified in Sec. 26.163(a)(1) for initial drug testing and in
Sec. 26.163(b)(1) for confirmatory drug testing;
(2) The individuals are subject to pre-access (or pre-employment),
random, for-cause, and post-event testing for alcohol at or below the
cutoff levels specified in Sec. 26.103(a) and breath specimens are
subject to confirmatory testing, if required, with an evidential breath
testing device that meets the requirements specified in Sec. 26.91;
(3) Urine specimens are tested for validity and the presence of
drugs and drug metabolites at a laboratory certified by HHS;
(4) Training is provided to address the knowledge and abilities
listed in Sec. 26.29(a)(1) through (10);
(5) An impartial and objective procedure is provided for the review
and reversal of any findings of an FFD policy violation; and
(6) Provisions are made to ensure that the testing agency or
organization notifies the licensee or other entity granting
authorization of any FFD policy violation.
(d) Individuals who have applied for authorization to have the
types of access or perform the activities described in paragraph (a) of
this section shall be subject to the applicable requirements of this
part and provided with the applicable protections of this part.
Sec. 26.27 Written policy and procedures.
(a) General. Each licensee and other entity who is subject to this
part shall establish, implement, and maintain written policies and
procedures to meet the general performance objectives and applicable
requirements of this part.
(b) Policy. The FFD policy statement must be clear, concise, and
readily available, in its most current form, to all individuals who are
subject to the policy. Methods of making the statement readily
available include, but are not limited to, posting the policy in
multiple work areas, providing individuals with brochures, or allowing
individuals to print the policy from a computer. The policy statement
must be written in sufficient detail to provide affected individuals
with information on what is expected of them and what consequences may
result from a lack of adherence to the policy. At a minimum, the
written policy statement must--
(1) Describe the consequences of the following actions:
(i) The use, sale, or possession of illegal drugs on or off site;
(ii) The abuse of legal drugs and alcohol; and
(iii) The misuse of prescription and over-the-counter drugs;
(2) Describe the requirement that individuals who are notified that
they have been selected for random testing must report to the
collection site within the time period specified by the licensee or
other entity;
(3) Describe the consequences of refusals to provide a specimen for
testing, as well as the consequences of subverting or attempting to
subvert the testing process;
(4) Prohibit the consumption of alcohol, at a minimum--
(i) Within an abstinence period of 5 hours preceding the
individual's arrival at the licensee's or other entity's facility,
except as permitted in Sec. 26.27(c)(3); and
(ii) During the period of any tour of duty;
(5) Convey that abstinence from alcohol for the 5 hours preceding
any scheduled tour of duty is considered to be a minimum that is
necessary, but may not be sufficient, to ensure that the individual is
fit for duty;
[[Page 50629]]
(6) Address other factors that could affect FFD, such as mental
stress, fatigue, or illness, and the use of prescription and over-the-
counter medications that could cause impairment;
(7) Provide a description of any program that is available to
individuals who are seeking assistance in dealing with drug, alcohol,
fatigue, or other problems that could adversely affect an individual's
ability to safely and competently perform the job duties that require
an individual to be subject to this part;
(8) Describe the consequences of violating the policy;
(9) Describe the individual's responsibility to report legal
actions, as defined in Sec. 26.5;
(10) Describe the responsibilities of managers, supervisors, and
escorts to report FFD concerns; and
(11) Describe the individual's responsibility to report FFD
concerns.
(c) Procedures. Each licensee and other entity who is subject to
this part shall prepare, implement, and maintain written procedures
that describe the methods to be used in implementing the FFD policy and
the requirements of this part. The procedures must--
(1) Describe the methods and techniques to be used in testing for
drugs and alcohol, including procedures for protecting the privacy and
due process rights of an individual who provides a specimen, procedures
for protecting the integrity of the specimen, and procedures used to
ensure that the test results are valid and attributable to the correct
individual;
(2) Describe immediate and followup actions that will be taken, and
the procedures to be used, in those cases in which individuals who are
subject to this part are determined to have--
(i) Been involved in the use, sale, or possession of illegal drugs;
(ii) Consumed alcohol to excess before the mandatory pre-work
abstinence period, during the mandatory pre-work abstinence period, or
while on duty, as determined by a test that measures BAC;
(iii) Attempted to subvert the testing process by adulterating or
diluting specimens (in vivo or in vitro), substituting specimens, or by
any other means;
(iv) Refused to provide a specimen for analysis; or
(v) Had legal action taken relating to drug or alcohol use, as
defined in Sec. 26.5;
(3) Describe the process that the licensee or other entity will use
to ensure that individuals who are called in to perform an unscheduled
working tour are fit for duty. Consumption of alcohol during the 5-hour
abstinence period required in paragraph (b)(4)(i) of this section may
not by itself preclude a licensee or other entity from using
individuals who are needed to respond to an emergency. At a minimum--
(i) The procedure must require the individual who is called in to
state whether the individual considers himself or herself fit for duty
and whether he or she has consumed alcohol within the pre-duty
abstinence period stated in the policy;
(ii) If the individual has consumed alcohol within this period and
the individual is called in, the procedure must--
(A) Require a determination of fitness by breath alcohol analysis
or other means;
(B) Require the establishment of controls and conditions under
which the individual who has been called in can perform work, if
necessary; and
(C) State that no sanctions may be imposed on an individual who is
called in to perform an unscheduled working tour and has consumed
alcohol within the pre-duty abstinence period stated in the policy.
(iii) If the individual reports that he or she considers himself or
herself to be unfit for duty for other reasons, including illness,
fatigue, or other potentially impairing conditions, and the individual
is called in, the procedure must require the establishment of controls
and conditions under which the individual can perform work, if
necessary;
(4) Describe the process to be followed if an individual's behavior
raises a concern regarding the possible use, sale, or possession of
illegal drugs on or off site; the possible possession or consumption of
alcohol on site; or impairment from any cause which in any way could
adversely affect the individual's ability to safely and competently
perform his or her duties. The procedure must require that individuals
who have an FFD concern about another individual's behavior shall
contact the personnel designated in the procedures to report the
concern.
(d) Review. The NRC may, at any time, review the written policy and
procedures to assure that they meet the performance objectives and
requirements of this part.
Sec. 26.29 Training.
(a) Training content. Licensees and other entities shall ensure
that individuals who are subject to this part have the following
knowledge and abilities (KAs):
(1) Knowledge of the policy and procedures that apply to the
individual, the methods that will be used to implement them, and the
consequences of violating the policy and procedures;
(2) Knowledge of the individual's role and responsibilities under
the FFD program;
(3) Knowledge of the roles and responsibilities of others, such as
the MRO and the human resources, FFD, and EAP staffs;
(4) Knowledge of the EAP services available to the individual;
(5) Knowledge of the personal and public health and safety hazards
associated with abuse of illegal and legal drugs and alcohol;
(6) Knowledge of the potential adverse effects on job performance
of prescription and over-the-counter drugs, alcohol, dietary factors,
illness, mental stress, and fatigue;
(7) Knowledge of the prescription and over-the-counter drugs and
dietary factors that have the potential to affect drug and alcohol test
results;
(8) Ability to recognize illegal drugs and indications of the
illegal use, sale, or possession of drugs;
(9) Ability to observe and detect performance degradation,
indications of impairment, or behavioral changes; and
(10) Knowledge of the individual's responsibility to report an FFD
concern and the ability to initiate appropriate actions, including
referrals to the EAP and person(s) designated by the licensee or other
entity to receive FFD concerns.
(b) Comprehensive examination. Individuals who are subject to this
part shall demonstrate the successful completion of training by passing
a comprehensive examination that addresses the KAs in paragraph (a) of
this section. The examination must include a comprehensive random
sampling of all KAs with questions that test each KA, including at
least one question for each KA. The minimum passing score required must
be 80 percent. Remedial training and testing are required for
individuals who fail to answer correctly at least 80 percent of the
test questions. The examination may be administered using a variety of
media, including, but not limited to, hard-copy test booklets with
separate answer sheets or computer-based questions.
(c) Training administration. Licensees and other entities shall
ensure that individuals who are subject to this part are trained, as
follows:
(1) Training must be completed before the licensee or other entity
grants initial authorization, as defined in Sec. 26.55, and must be
current before the licensee or other entity grants an authorization
update, as defined in Sec. 26.57, or authorization reinstatement, as
defined in Sec. 26.59;
[[Page 50630]]
(2) Individuals shall complete refresher training on a nominal 12-
month frequency, or more frequently where the need is indicated.
Individuals who pass a comprehensive annual examination that meets the
requirements in paragraph (b) of this section may forgo the refresher
training; and
(3) Initial and refresher training may be delivered using a variety
of media (including, but not limited to, classroom lectures, required
reading, video, or computer-based training systems). The licensee or
other entity shall monitor the completion of training and provide a
qualified instructor or designated subject matter expert to answer
questions during the course of training.
(d) Acceptance of training. Licensees and other entities may accept
training of individuals who have been subject to another Part 26
program and who have, within the past 12 months, either had initial or
refresher training, or have successfully passed a comprehensive
examination that meets the requirements in paragraph (b) of this
section.
Sec. 26.31 Drug and alcohol testing.
(a) General. To provide a means to deter and detect substance
abuse, licensees and other entities who are subject to this part shall
implement drug and alcohol testing programs for individuals who are
subject to this part.
(b) Assuring the honesty and integrity of FFD program personnel.
(1) Licensees and other entities who are subject to this part shall
carefully select and monitor FFD program personnel, as defined in Sec.
26.25(a)(4), based upon the highest standards for honesty and
integrity, and shall implement measures to ensure that these standards
are maintained. The measures must ensure that the honesty and integrity
of these individuals are not compromised and that FFD program personnel
are not subject to influence attempts attributable to personal
relationships with any individuals who are subject to testing, an
undetected or untreated substance abuse problem, or other factors. At a
minimum, these measures must include the following considerations:
(i) Licensees and other entities shall complete appropriate
background investigations, credit and criminal history checks, and
psychological assessments of FFD program personnel before assignment to
tasks directly associated with administration of the FFD program. The
background investigations, credit and criminal history checks, and
psychological assessments conducted in order to grant unescorted access
authorization to individuals under a nuclear power plant licensee's
access authorization program are acceptable to meet the requirements of
this paragraph. The credit and criminal history checks and
psychological assessments must be updated nominally every 5 years;
(ii) Individuals who have personal relationships with the
individual being tested may not perform any assessment or evaluation
procedures, including, but not limited to, determinations of fitness.
These personal relationships may include, but are not limited to,
supervisors, coworkers within the same work group, and relatives of the
donor.
(iii) Except if a directly observed collection is required, a
collector who has a personal relationship with the donor may collect
specimens from the donor only if the integrity of specimen collections
in these instances is assured through the following means:
(A) The collection must be monitored by an individual who does not
have a personal relationship with the donor and who is designated by
the licensee or other entity for this purpose, including, but not
limited to, security force or quality assurance personnel; and
(B) Individuals who are designated to monitor collections in these
instances shall be trained to monitor specimen collections and the
preparation of specimens for transfer or shipping in accordance with
the requirements of this part;
(iv) If a specimen must be collected under direct observation, the
collector or an individual who serves as the observer, as permitted
under Sec. 26.115(e), may not have a personal relationship with the
donor; and
(v) FFD program personnel shall be subject to a behavioral
observation program designed to assure that they continue to meet the
highest standards of honesty and integrity. When an MRO and MRO staff
are on site at a licensee's or other entity's facility, the MRO and MRO
staff shall be subject to behavioral observation.
(2) Licensees and other entities who are subject to this part may
rely upon a local hospital or other organization that meets the
requirements of 49 CFR Part 40, ``Procedures for Department of
Transportation Workplace Drug and Alcohol Testing Programs'' (65 FR
41944; August 9, 2001) to collect specimens for drug and alcohol
testing from the FFD program personnel listed in Sec. 26.25(a)(4).
(c) Conditions for testing. Licensees and other entities shall
administer drug and alcohol tests to individuals who are subject to
this part under the following conditions:
(1) Pre-access. In order to grant initial, updated, or reinstated
authorization to an individual, as specified in subpart C of this part;
(2) For cause. In response to an individual's observed behavior or
physical condition indicating possible substance abuse or after
receiving credible information that an individual is engaging in
substance abuse, as defined in Sec. 26.5;
(3) Post-event. As soon as practical after an event involving a
human error that was committed by an individual who is subject to this
part, where the human error may have caused or contributed to the
event. The licensee or other entity shall test the individual(s) who
committed the error(s), and need not test individuals who were affected
by the event but whose actions likely did not cause or contribute to
the event. The individual(s) who committed the human error(s) shall be
tested if the event resulted in--
(i) A significant illness or personal injury to the individual to
be tested or another individual, which within 4 hours after the event
is recordable under the Department of Labor standards contained in 29
CFR 1907.4, and subsequent amendments thereto, and results in death,
days away from work, restricted work, transfer to another job, medical
treatment beyond first aid, loss of consciousness, or other significant
illness or injury as diagnosed by a physician or other licensed health
care professional, even if it does not result in death, days away from
work, restricted work or job transfer, medical treatment beyond first
aid, or loss of consciousness;
(ii) A radiation exposure or release of radioactivity in excess of
regulatory limits; or
(iii) Actual or potential substantial degradations of the level of
safety of the plant;
(4) Followup. As part of a followup plan to verify an individual's
continued abstinence from substance abuse; and
(5) Random. On a statistically random and unannounced basis, so
that all individuals in the population subject to testing have an equal
probability of being selected and tested.
(d) General requirements for drug and alcohol testing. (1)
Substances tested. At a minimum, licensees and other entities shall
test for marijuana metabolite, cocaine metabolite, opiates (codeine,
morphine, 6-acetylmorphine), amphetamines (amphetamine,
methamphetamine), phencyclidine, adulterants, and alcohol.
(i) In addition, licensees and other entities may consult with
local law enforcement authorities, hospitals, and
[[Page 50631]]
drug counseling services to determine whether other drugs with abuse
potential are being used in the geographical locale of the facility and
by the local workforce that may not be detected in the panel of drugs
and drug metabolites specified in paragraph (d)(1) of this section.
(A) When appropriate, the licensee or other entity may add other
drugs identified in accordance with paragraph (d)(1)(i) of this section
to the panel of substances for testing, but only if the additional
drugs are listed in Schedules I-V of section 202 of the Controlled
Substances Act [21 U.S.C. 812].
(B) The licensee or other entity shall establish appropriate cutoff
limits for these substances.
(C) The licensee or other entity shall establish rigorous testing
procedures for these substances that are consistent with the intent of
this part, so that the MRO can evaluate the use of these substances.
(D) The licensee or other entity may not conduct an analysis for
any drug or drug metabolites except those identified in paragraph
(d)(1) of this section unless the assay and cutoff levels to be used
are certified in writing as scientifically sound and legally defensible
by an independent, qualified forensic toxicologist. The forensic
toxicologist may not be an employee of the licensee or entity, and
shall either be a Diplomate of the American Board of Forensic
Toxicology or currently hold, or would be eligible to hold, the
position of Responsible Person at an HHS-certified laboratory, as
specified in Sec. 26.155(a) of this part. All new assays and cutoff
levels must be properly validated in accordance with established
forensic toxicological standards before implementation. Certification
of the assay and cutoff levels is not required if the HHS Guidelines
are revised to authorize use of the assay in testing for the additional
drug or drug metabolites and the licensee or other entity uses the
cutoff levels established in the HHS Guidelines for the drug or drug
metabolites, or if the licensee or other entity received written
approval of the NRC to test for the additional drug or drug metabolites
before [Insert implementation date of final rule].
(ii) When conducting post-event, followup, and for-cause testing,
as defined in Sec. 26.31(c), licensees and other entities may test for
any drugs listed on Schedules I-V of section 202 of the Controlled
Substances Act [21 U.S.C. 812] that an individual is suspected of
having abused, and may consider any drugs or metabolites so detected
when determining appropriate action under Subpart D of this part. If
the drug or metabolites for which testing will be performed under this
paragraph are not included in the FFD program's drug panel, the assay
and cutoff levels to be used in testing for the additional drugs must
be certified by a forensic toxicologist in accordance with paragraph
(d)(1)(i)(D) of this section. Test results that fall below the
established cutoff levels may not be considered when determining
appropriate action under Subpart D of this part.
(2) Random testing. Random testing must--
(i) Be administered in a manner that provides reasonable assurance
that individuals are unable to predict the time periods during which
specimens will be collected. At a minimum, the FFD program shall--
(A) Take reasonable steps to either conceal from the workforce that
collections will be performed during a scheduled collection period or
create the appearance that specimens are being collected during a
portion of each day on at least 4 days in each calendar week at each
site; and
(B) Collect specimens on an unpredictable schedule, including
weekends, backshifts, and holidays, and at various times during a
shift;
(ii) At a minimum, be administered by the FFD program on a nominal
weekly frequency;
(iii) Require individuals who are selected for random testing to
report to the collection site as soon as reasonably practicable after
notification, within the time period specified in the FFD program
policy;
(iv) Ensure that all individuals in the population subject to
testing have an equal probability of being selected and tested.
Individuals who are off site when selected for testing, and not
reasonably available for testing when selected, shall be tested at the
earliest reasonable and practical opportunity when both the donor and
collectors are available to collect specimens for testing and without
prior notification to the individual that he or she has been selected
for testing;
(v) Provide that an individual completing a test is immediately
eligible for another unannounced test; and
(vi) Ensure that the sampling process used to select individuals
for random testing provides that the number of random tests performed
annually is equal to at least 50 percent of the population that is
subject to the FFD program.
(3) Drug testing. (i) Testing of urine specimens for drugs, except
initial tests performed by licensee testing facilities under paragraph
(d)(3)(ii) of this section, must be performed in a laboratory that is
certified by HHS for that purpose, consistent with its standards and
procedures for certification. Specimens sent to HHS-certified
laboratories must be subject to initial validity and drug testing by
the laboratory. Specimens that yield non-negative initial validity or
drug test results must be subject to confirmatory testing by the
laboratory, except for invalid specimens that cannot be tested.
Licensees and other entities shall ensure that laboratories report
results for all specimens sent for testing, including blind performance
test samples.
(ii) Licensees and other entities may conduct validity screening
and initial validity and drug tests of urine aliquots to determine
which specimens are valid and negative and need no further testing,
provided that the licensee's or other entity's staff possesses the
necessary training and skills for the tasks assigned, the staff's
qualifications are documented, and adequate quality controls for the
testing are implemented.
(iii) At a minimum, licensees and other entities shall apply the
cutoff levels specified in Sec. 26.163(a)(1) for initial drug testing
and in Sec. 26.163(b)(1) for confirmatory drug testing. At their
discretion, licensees and other entities may implement programs with
lower cutoff levels for drug testing.
(A) If a licensee or other entity implements lower cutoff levels,
and the MRO determines that an individual has violated the FFD policy
using the licensee's or other entity's more stringent cutoff levels,
the individual shall be subject to all management actions and sanctions
required by the licensee's or other entity's FFD policy and this part,
as if the individual had a confirmed positive drug test result using
the cutoff levels specified in this part. The licensee or other entity
shall document the more stringent cutoff levels in any written policies
and procedures in which cutoff levels for drug testing are described.
(B) The licensee or other entity shall uniformly apply the cutoff
levels listed in Sec. 26.163(a)(1) for initial drug testing and in
Sec. 26.163(b)(1) for confirmatory drug testing, or any more stringent
cutoff levels implemented by the FFD program, to all tests performed
under this part and equally to all individuals who are tested under
this part, except as permitted in Sec. Sec. 26.31(d)(1)(ii) and
26.163(a)(2).
(C) In addition, the scientific and technical suitability of any
more stringent cutoff levels must be evaluated and certified, in
writing, by a forensic toxicologist who meets the requirements set
forth in Sec. 26.31(d)(1)(i)(D).
[[Page 50632]]
Certification of the more stringent cutoff levels is not required if
the HHS Guidelines are revised to lower the cutoff levels for the drug
or drug metabolites in Federal workplace drug testing programs and the
licensee or other entity implements the cutoff levels published in the
HHS Guidelines, or if the licensee or other entity received written
approval of the NRC to test for lower cutoff levels before [Insert
implementation date of final rule].
(4) Alcohol testing. Initial tests for alcohol must be administered
by breath or oral fluids analysis using alcohol analysis devices that
meet the requirements of Sec. 26.91(a). If the initial test shows a
BAC of 0.02 percent or greater, a confirmatory test for alcohol must be
performed. The confirmatory test must be performed with an evidential
breath testing device that meets the requirements of Sec. 26.91(b).
(5) Medical conditions. (i) If an individual has a medical
condition that makes collection of breath, oral fluids, or urine
specimens difficult or hazardous, the MRO may authorize an alternative
evaluation process, tailored to the individual case, to meet the
requirements of this part for drug and alcohol testing. The alternative
process must include measures to prevent subversion and achieve results
that are comparable to those produced by urinalysis for drugs and
breath analysis for alcohol.
(ii) If an individual requires medical attention, including, but
not limited to, an injured worker in an emergency medical facility who
is required to have a post-event test, treatment may not be delayed to
conduct drug and alcohol testing.
(6) Limitations of testing. Specimens collected under NRC
regulations may only be designated or approved for testing as described
in this part and may not be used to conduct any other analysis or test
without the written permission of the donor. Analyses and tests that
may not be conducted include, but are not limited to, DNA testing,
serological typing, or any other medical or genetic test used for
diagnostic or specimen identification purposes.
Sec. 26.33 Behavioral observation.
Licensees and other entities who are subject to this part shall
ensure that the individuals listed in Sec. 26.25(a) and (c), if
necessary, are subject to behavioral observation. Behavioral
observation must be performed by individuals who are trained in
accordance with Sec. 26.29 to detect behaviors that may indicate
possible use, sale, or possession of illegal drugs; use or possession
of alcohol on site or while on duty; or impairment from fatigue or any
cause that, if left unattended, may constitute a risk to the health and
safety of the public. Individuals who are subject to this part shall
report any FFD concerns about other individuals who are subject to this
part to the personnel designated in the FFD policy.
Sec. 26.35 Employee assistance programs.
(a) Each licensee and other entity who is subject to this part
shall maintain an EAP to strengthen the FFD program by offering
confidential assessment, short-term counseling, referral services, and
treatment monitoring to its employees who have problems that could
adversely affect the employees' abilities to safely and competently
perform their duties. Employee assistance programs must be designed to
achieve early intervention and provide for confidential assistance.
(b) Licensees and other entities need not provide EAP services to a
C/V's employees and individuals who have applied for, but have not yet
been granted, authorization.
(c) The EAP staff shall protect the identity and privacy of any
individual (including those who have self-referred) seeking assistance
from the EAP, except if the individual waives the right to privacy in
writing or a determination is made that the individual's condition or
actions pose or have posed an immediate hazard to himself or herself or
others.
(1) Licensees and other entities may not require the EAP to
routinely report the names of individuals who self-refer to the EAP or
the nature of the assistance the individuals sought.
(2) If EAP personnel determine that an individual poses or has
posed an immediate hazard to himself or herself or others, EAP
personnel shall so inform FFD program management, and need not obtain a
written waiver of the right to privacy from the individual. The
individual conditions or actions that EAP personnel shall report to FFD
program management include, but are not limited to, substantive reasons
to believe that the individual--
(i) Is likely to commit self-harm or harm to others;
(ii) Has been impaired from using drugs or alcohol while in a work
status and has a continuing substance abuse disorder that makes it
likely he or she will be impaired while in a work status in the future;
or
(iii) Has ever engaged in any acts that would be reportable under
Sec. 26.219(b)(1) through (b)(3).
(3) If a licensee or other entity receives a report from EAP
personnel under paragraph (c)(2) of this section, the licensee or other
entity shall ensure that the requirements of Sec. Sec. 26.69(d) and
26.77(b) are implemented, as applicable.
Sec. 26.37 Protection of information.
(a) Each licensee or other entity who is subject to this part who
collects personal information about an individual for the purpose of
complying with this part, shall establish and maintain a system of
files and procedures to protect the personal information. Licensees and
other entities shall maintain and use such records with the highest
regard for individual privacy.
(b) Licensees and other entities shall obtain a signed consent that
authorizes the disclosure of the personal information collected and
maintained under this part before disclosing the personal information,
except for disclosures to the following individuals:
(1) The subject individual or his or her representative, when the
individual has designated the representative in writing for specified
FFD matters;
(2) Assigned MROs and MRO staff;
(3) NRC representatives;
(4) Appropriate law enforcement officials under court order;
(5) A licensee's or other entity's representatives who have a need
to have access to the information in performing assigned duties,
including determinations of fitness, audits of FFD programs, and human
resources functions;
(6) The presiding officer in a judicial or administrative
proceeding that is initiated by the subject individual;
(7) Persons deciding matters under review in Sec. 26.39; and
(8) Other persons pursuant to court order.
(c) Personal information that is collected under this part must be
disclosed to other licensees and entities, including C/Vs, or their
authorized representatives, who are legitimately seeking the
information for authorization decisions as required by this part and
who have obtained a signed release from the subject individual.
(d) Upon receipt of a written request by the subject individual or
his or her designated representative, the licensee, other entity, HHS-
certified laboratory, or MRO possessing such records shall promptly
provide copies of all records pertaining to the determination of a
violation of the FFD policy, including test results, MRO reviews, and
management actions pertaining to the subject individual. The licensee
or other entity shall obtain records related to the results of any
relevant laboratory certification, review, or revocation-of-
certification proceedings from the HHS-
[[Page 50633]]
certified laboratory and provide them to the subject individual upon
request.
(e) A licensee's or other entity's contracts with HHS-certified
laboratories and licensee testing facility procedures must require that
test records be maintained in confidence, except as provided in
paragraphs (b), (c), and (d) of this section.
(f) This section does not authorize the licensee or other entity to
withhold evidence of criminal conduct from law enforcement officials.
Sec. 26.39 Review process for fitness-for-duty policy violations.
(a) Each licensee and other entity who is subject to this part
shall establish procedures for the review of a determination that an
individual who they employ or who has applied for authorization has
violated the FFD policy. The procedure must provide for an objective
and impartial review of the facts related to the determination that the
individual has violated the FFD policy.
(b) The procedure must provide notice to the individual of the
grounds for the determination that the individual has violated the FFD
policy, and must provide an opportunity for the individual to respond
and submit additional relevant information.
(c) The procedure must ensure that the review is conducted by more
than one individual and that the individuals who conduct the review are
not associated with the administration of the FFD program (see the
description of FFD program personnel in Sec. 26.25(a)(4)). The
individuals who conduct the review may be management personnel.
(d) If the review finds in favor of the individual, the licensee or
other entity shall update the relevant records to reflect the outcome
of the review and delete or correct all information the review found to
be inaccurate.
(e) Licensees and other entities need not provide a review
procedure to a C/V's employee or applicant when the C/V is
administering its own FFD program and the FFD policy violation was
determined under the C/V's program.
Sec. 26.41 Audits and corrective action.
(a) General. Each licensee and other entity who is subject to this
part is responsible for the continuing effectiveness of the FFD
program, including FFD program elements that are provided by C/Vs, the
FFD programs of any C/Vs that are accepted by the licensee or other
entity, and the programs of the HHS-certified laboratories upon whom
the licensee or other entity and its C/Vs rely. Each licensee and other
entity shall ensure that these programs are audited and that corrective
actions are taken to resolve any problems identified.
(b) FFD program. Each licensee and other entity who is subject to
this part shall ensure that the entire FFD program is audited as
needed, but no less frequently than nominally every 24 months.
Licensees and other entities are responsible for determining the
appropriate frequency, scope, and depth of additional auditing
activities within the nominal 24-month period based on the review of
program performance indicators, such as the frequency, nature, and
severity of discovered problems, testing errors, personnel or
procedural changes, previous audit findings, and ``lessons learned.''
(c) C/Vs and HHS-certified laboratories. (1) FFD services that are
provided to a licensee or other entity by C/V personnel who are off
site or are not under the direct daily supervision or observation of
the licensee's or other entity's personnel and HHS-certified
laboratories must be audited on a nominal 12-month frequency.
(2) Audits of HHS-certified laboratories that are conducted for
licensees and other entities who are subject to this part need not
duplicate areas inspected in the most recent HHS certification
inspection. However, the licensee and other entity shall review the HHS
certification inspection records and reports to identify any areas in
which the licensee or other entity uses services that the HHS
certification inspection did not address. The licensee or other entity
shall ensure that any such areas are audited on a nominal 12-month
frequency. Licensees and other entities need not audit organizations
and professionals who may provide an FFD program service to the
licensee or other entity, but who are not routinely involved in
providing services to a licensee's or other entity's FFD program, as
specified in Sec. 26.25(b)(1).
(d) Contracts. (1) Licensees' and other entities' contracts with C/
Vs and HHS-certified laboratories must reserve the right to audit the
C/V, the C/V's subcontractors providing FFD program services, and the
HHS-certified laboratories at any time, including at unannounced times,
as well as to review all information and documentation that is
reasonably relevant to the audits.
(2) Licensees' and other entities' contracts with C/Vs and HHS-
certified laboratories must also permit the licensee or other entity to
obtain copies of and take away any documents, including reviews and
inspections pertaining to a laboratory's certification by HHS, and any
other data that may be needed to assure that the C/V, its
subcontractors, or the HHS-certified laboratory are performing their
functions properly and that staff and procedures meet applicable
requirements. In a contract with a licensee or other entity who is
subject to this part, an HHS-certified laboratory may reasonably limit
the use and dissemination of any documents copied or taken away by the
licensee's or other entity's auditors in order to ensure the protection
of proprietary information and donors' privacy.
(3) In addition, before awarding a contract, the licensee or other
entity shall ensure completion of pre-award inspections and/or audits
of the procedural aspects of the HHS-certified laboratory's drug-
testing operations, except as provided in paragraph (g)(5) of this
section.
(e) Conduct of audits. Audits must focus on the effectiveness of
the FFD program or program element(s), as appropriate, and must be
conducted by individuals who are qualified in the subject(s) being
audited. The individuals performing the audit of the FFD program or
program element(s) shall be independent from both the subject FFD
program's management and from personnel who are directly responsible
for implementing the FFD program.
(f) Audit results. The result of the audits, along with any
recommendations, must be documented and reported to senior corporate
and site management. Each audit report must identify conditions that
are adverse to the proper performance of the FFD program, the cause of
the condition(s), and, when appropriate, recommended corrective
actions. The licensee or other entity shall review the audit findings
and take corrective actions, including re-auditing of the deficient
areas where indicated, to preclude, within reason, repetition of the
condition. The resolution of the audit findings and corrective actions
must be documented.
(g) Sharing of audits. Licensees and other entities may jointly
conduct audits, or may accept audits of C/Vs and HHS-certified
laboratories that were conducted by other licensees and entities who
are subject to this part, if the audit addresses the services obtained
from the C/V or HHS-certified laboratory by each of the sharing
licensees and other entities.
(1) Licensees and other entities shall review audit records and
reports to identify any areas that were not covered by the shared or
accepted audit.
(2) Licensees and other entities shall ensure that FFD program
elements and services upon which the licensee or
[[Page 50634]]
entity relies are audited, if the program elements and services were
not addressed in the shared audit.
(3) Sharing licensees and other entities need not re-audit the same
C/V or HHS-certified laboratory for the same period of time.
(4) Each sharing licensee and other entity shall maintain a copy of
the shared audit and HHS certification inspection records and reports,
including findings, recommendations, and corrective actions.
(5) If an HHS-certified laboratory loses its certification, in
whole or in part, a licensee or other entity is permitted to
immediately use another HHS-certified laboratory that has been audited
within the previous 12 months by another NRC licensee or entity who is
subject to this part. Within 3 months after the change, the licensee or
other entity shall ensure that an audit is completed of any areas that
have not been audited by another licensee or entity who is subject to
this part within the past 12 months.
Subpart C--Granting and Maintaining Authorization
Sec. 26.51 Purpose.
This subpart contains FFD requirements for granting and maintaining
authorization to have the types of access and be assigned to perform
the job duties that are specified in Sec. 26.25(a).
Sec. 26.53 General provisions.
(a) In order to grant authorization to individuals, a licensee or
other entity who is subject to this part shall meet the requirements in
this subpart for initial authorization, authorization update,
authorization reinstatement, or authorization with potentially
disqualifying FFD information, as applicable.
(b) For individuals who have previously held authorization under
this part but whose authorization has since been favorably terminated,
the licensee or other entity shall implement the requirements for
either initial authorization, authorization update, or authorization
reinstatement, based upon the total number of days that the
individual's authorization is interrupted, to include the day after the
individual's last period of authorization was terminated and the
intervening days until the day upon which the licensee or other entity
grants authorization to the individual. If potentially disqualifying
FFD information is disclosed or discovered about an individual,
licensees and other entities shall implement the applicable
requirements in Sec. 26.69 in order to grant or maintain an
individual's authorization.
(c) The licensee or other entity shall ensure that an individual
has met the applicable FFD training requirements in Sec. Sec. 26.29
and 26.197(c) before granting authorization to the individual.
(d) Licensees and other entities who are seeking to grant
authorization to an individual who is subject to another FFD program
that complies with this part may rely on the transferring FFD program
to satisfy the requirements of this part. The individual may maintain
his or her authorization if he or she continues to be subject to either
the receiving FFD program or the transferring FFD program, or a
combination of elements from both programs that collectively satisfy
the requirements of this part.
Sec. 26.55 Initial authorization.
(a) Before granting authorization to an individual who has never
held authorization under this part or whose authorization has been
interrupted for a period of 3 years or more and whose last period of
authorization was terminated favorably, the licensee or other entity
shall--
(1) Obtain and review a self-disclosure in accordance with the
applicable requirements of Sec. 26.61;
(2) Complete a suitable inquiry in accordance with the applicable
requirements of Sec. 26.63;
(3) Ensure that the individual is subject to pre-access drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.65; and
(4) Ensure that the individual is subject to random drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.67.
(b) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except in accordance with Sec. 26.69.
Sec. 26.57 Authorization update.
(a) Before granting authorization to an individual whose
authorization has been interrupted for more than 365 days but less than
3 years and whose last period of authorization was terminated
favorably, the licensee or other entity shall--
(1) Obtain and review a self-disclosure in accordance with the
applicable requirements of Sec. 26.61;
(2) Complete a suitable inquiry in accordance with the applicable
requirements of Sec. 26.63;
(3) Ensure that the individual is subject to pre-access drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.65; and
(4) Ensure that the individual is subject to random drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.67.
(b) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except in accordance with Sec. 26.69.
Sec. 26.59 Authorization reinstatement.
(a) In order to grant authorization to an individual whose
authorization has been interrupted for a period of more than 30 days
but no more than 365 days and whose last period of authorization was
terminated favorably, the licensee or other entity shall--
(1) Obtain and review a self-disclosure in accordance with the
applicable requirements of Sec. 26.61;
(2) Complete a suitable inquiry in accordance with the requirements
of Sec. 26.63 within 5 business days of reinstating authorization. If
the suitable inquiry is not completed within 5 business days due to
circumstances that are outside of the licensee's or other entity's
control and the licensee or other entity is not aware of any
potentially disqualifying information regarding the individual within
the past 5 years, the licensee or other entity may maintain the
individual's authorization for an additional 5 business days. If the
suitable inquiry is not completed within 10 business days of
reinstating authorization, the licensee or other entity shall
administratively withdraw the individual's authorization until the
suitable inquiry is completed;
(3) Ensure that the individual is subject to pre-access drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.65; and
(4) Ensure that the individual is subject to random drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.67.
(b) If a licensee or other entity administratively withdraws an
individual's authorization under paragraph (a)(2) of this section, and
until the suitable inquiry is completed, the licensee or other entity
may not record the administrative action to withdraw authorization as
an unfavorable termination and may not disclose it in response to a
suitable inquiry conducted under the provisions of Sec. 26.63, a
background investigation conducted under the provisions of this
chapter, or any other inquiry or investigation. The individual may not
be required to disclose the administrative action in response to
requests for self-disclosure of potentially disqualifying FFD
information.
[[Page 50635]]
(c) Before granting authorization to an individual whose
authorization has been interrupted for a period of no more than 30 days
and whose last period of authorization was terminated favorably, the
licensee or other entity shall--
(1) Obtain and review a self-disclosure in accordance with the
applicable requirements of Sec. 26.61;
(2) If the individual's authorization was interrupted for more than
5 days, ensure that the individual is subject to pre-access drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.65; and
(3) Ensure that the individual is subject to random drug and
alcohol testing in accordance with the applicable requirements of Sec.
26.67.
(d) If potentially disqualifying FFD information is disclosed or
discovered, the licensee or other entity may not grant authorization to
the individual, except in accordance with Sec. 26.69.
Sec. 26.61 Self-disclosure and employment history.
(a) Before granting authorization, the licensee or other entity
shall obtain a written self-disclosure and employment history from the
individual who is applying for authorization, except as follows:
(1) If an individual previously held authorization under this part,
and the licensee or other entity has verified that the individual's
last period of authorization was terminated favorably, and the
individual has been subject to a behavioral observation and arrest-
reporting program that meets the requirements of this part throughout
the period since the individual's last authorization was terminated,
the granting licensee or other entity need not obtain the self-
disclosure or employment history in order to grant authorization; and
(2) If the individual's last period of authorization was terminated
favorably within the past 30 days, the licensee or other entity need
not obtain the employment history.
(b) The written self-disclosure must--
(1) State whether the individual has--
(i) Violated a licensee's or other entity's FFD policy;
(ii) Had authorization denied or terminated unfavorably under
Sec. Sec. 26.61(d), 26.63(d), 26.65(h), 26.67(c), 26.69(f), or
26.75(b) through (e);
(iii) Used, sold, or possessed illegal drugs;
(iv) Abused legal drugs or alcohol;
(v) Subverted or attempted to subvert a drug or alcohol testing
program;
(vi) Refused to take a drug or alcohol test;
(vii) Been subject to a plan for substance abuse treatment (except
for self-referral); or
(viii) Had legal action or employment action, as defined in Sec.
26.5, taken for alcohol or drug use;
(2) Address the specific type, duration, and resolution of any
matter disclosed, including, but not limited to, the reason(s) for any
unfavorable termination or denial of authorization; and
(3) Address the shortest of the following periods:
(i) The past 5 years;
(ii) Since the individual's eighteenth birthday; or
(iii) Since the individual's last period of authorization was
terminated, if authorization was terminated favorably within the past 3
years.
(c) The individual shall provide a list of all employers, including
the current employer, if any, with dates of employment, for the
shortest of the following periods:
(1) The past 3 years;
(2) Since the individual's eighteenth birthday; or
(3) Since authorization was last terminated, if authorization was
terminated favorably within the past 3 years.
(d) Falsification of the self-disclosure statement or employment
history is sufficient cause for denial of authorization.
Sec. 26.63 Suitable inquiry.
(a) The licensee or other entity shall conduct a suitable inquiry,
on a best effort basis, to verify the individual's self-disclosed
information and determine whether any potentially disqualifying FFD
information is available, except if all of the following conditions are
met:
(1) The individual previously held authorization under this part;
(2) The licensee or other entity has verified that the individual's
last period of authorization was terminated favorably; and
(3) The individual has been subject to a behavioral observation and
arrest-reporting program that meets the requirements of this part
throughout the period of interruption.
(b) To meet the suitable inquiry requirement, licensees and other
entities may rely upon the information that other licensees and
entities who are subject to this part have gathered for previous
periods of authorization. Licensees and other entities may also rely
upon those licensees' and entities' determinations of fitness, as well
as their reviews and resolutions of potentially disqualifying FFD
information, for previous periods of authorization.
(c) The licensee or other entity shall conduct the suitable
inquiry, on a best effort basis, by questioning both present and former
employers.
(1) For the claimed employment period, the suitable inquiry must
ascertain the reason for termination, eligibility for rehire, and other
information that could reflect on the individual's fitness to be
granted authorization.
(2) If the claimed employment was military service, the licensee or
other entity who is conducting the suitable inquiry shall request a
characterization of service, reason for separation, and any
disciplinary actions related to potentially disqualifying FFD
information. If the individual's last duty station cannot provide this
information, the licensee or other entity may accept a hand-carried
copy of the DD 214 presented by the individual which on face value
appears to be legitimate. The licensee or other entity may also accept
a copy of a DD 214 provided by the custodian of military records.
(3) If a company, previous employer, or educational institution to
whom the licensee or other entity has directed a request for
information refuses to provide information or indicates an inability or
unwillingness to provide information within 3 business days of the
request, the licensee or other entity shall document this refusal,
inability, or unwillingness in the licensee's or other entity's record
of the investigation, and obtain a confirmation of employment or
educational enrollment and attendance from at least one alternate
source, with suitable inquiry questions answered to the best of the
alternate source's ability. This alternate source may not have been
previously used by the licensee or other entity to obtain information
about the individual's character. If the licensee or other entity uses
an alternate source because employer information is not forthcoming
within 3 business days of the request, the licensee or other entity
need not delay granting authorization to wait for any employer
response.
(d) In response to another licensee's or other entity's inquiry and
presentation of an individual's signed release authorizing the
disclosure of information, a licensee or other entity shall disclose
whether the subject individual's authorization was denied or terminated
unfavorably as a result of a violation of an FFD policy and shall make
available the information upon which the denial or unfavorable
termination of authorization was based, including, but not limited to,
drug or alcohol test results. The failure of an
[[Page 50636]]
individual to authorize the release of information for the suitable
inquiry is sufficient cause to deny authorization.
(e) In conducting a suitable inquiry, the licensee or other entity
may obtain information and documents by electronic means, including,
but not limited to, telephone, facsimile, or e-mail. The licensee or
other entity shall make a record of the contents of the telephone call
and shall retain that record, and any documents or electronic files
obtained electronically, in accordance with Sec. Sec. 26.211 and
26.213(a), (b), and (c), as applicable.
(f) The licensee or other entity shall conduct the suitable inquiry
as follows:
(1) Initial authorization. The period of the suitable inquiry must
be the past 3 years or since the individual's eighteenth birthday,
whichever is shorter. For the 1-year period immediately preceding the
date upon which the individual applies for authorization, the licensee
or other entity shall conduct the suitable inquiry with every employer,
regardless of the length of employment. For the remaining 2-year
period, the licensee or other entity shall conduct the suitable inquiry
with the employer by whom the individual claims to have been employed
the longest within each calendar month, if the individual claims
employment during the given calendar month.
(2) Authorization update. The period of the suitable inquiry must
be the period since authorization was terminated. For the 1-year period
immediately preceding the date upon which the individual applies for
authorization, the licensee or other entity shall conduct the suitable
inquiry with every employer, regardless of the length of employment.
For the remaining period since authorization was terminated, the
licensee or other entity shall conduct the suitable inquiry with the
employer by whom the individual claims to have been employed the
longest within each calendar month, if the individual claims employment
during the given calendar month.
(3) Authorization reinstatement after an interruption of more than
30 days. The period of the suitable inquiry must be the period since
authorization was terminated. The licensee or other entity shall
conduct the suitable inquiry with the employer by whom the individual
claims to have been employed the longest within the calendar month, if
the individual claims employment during the given calendar month.
Sec. 26.65 Pre-access drug and alcohol testing.
(a) Purpose. This section contains pre-access testing requirements
for granting authorization to an individual who either has never held
authorization or whose last period of authorization was terminated
favorably and about whom no potentially disqualifying FFD information
has been discovered or disclosed that was not previously reviewed and
resolved by a licensee or other entity who is subject to this part.
(b) Accepting tests conducted within the past 30 days. If an
individual has negative results from drug and alcohol tests that were
conducted in accordance with the requirements of this part before the
individual applied for authorization from the licensee or other entity,
and the specimens for such testing were collected within the 30-day
period preceding the day upon which the licensee or other entity grants
authorization to the individual, the licensee or other entity may rely
upon the results of those drug and alcohol tests to meet the
requirements for pre-access testing in this section.
(c) Initial authorization and authorization update. Before granting
authorization to an individual who has never been authorized or whose
authorization has been interrupted for a period of more than 365 days,
the licensee or other entity shall verify that the results of pre-
access drug and alcohol tests are negative. The licensee or other
entity need not conduct pre-access testing if--
(1) An individual previously held authorization under this part and
has been subject to both a drug and alcohol testing program that
includes random testing and a behavioral observation and arrest
reporting program which meet the requirements of this part from the
date upon which the individual's last authorization was terminated
through the date upon which the individual is granted authorization; or
(2) The licensee or other entity relies upon negative results from
drug and alcohol tests that were conducted before the individual
applied for authorization, as permitted under paragraph (b) of this
section, and the individual remains subject to a behavioral observation
and arrest reporting program that meets the requirements of this part,
beginning on the date upon which the drug and alcohol testing was
conducted through the date upon which the individual is granted
authorization and thereafter.
(d) Authorization reinstatement after an interruption of more than
30 days. (1) In order to reinstate authorization for an individual
whose authorization has been interrupted for a period of more than 30
days but no more than 365 days, except as permitted in paragraph (d)(2)
of this section, the licensee or other entity shall--
(i) Verify that the individual has negative results from alcohol
testing and collect a specimen for drug testing before reinstating
authorization; and
(ii) Verify that the drug test results are negative within 5
business days of specimen collection or administratively withdraw
authorization until the drug test results are received.
(2) The licensee or other entity need not conduct pre-access
testing of these individuals if--
(i) The individual previously held authorization under this part
and has been subject both to a drug and alcohol testing program that
includes random testing and a behavioral and arrest-reporting program
that meet the requirements of this part from the date upon which the
individual's last authorization was terminated through the date upon
which the individual is granted authorization; or
(ii) The licensee or other entity relies upon negative results from
drug and alcohol tests that were conducted before the individual
applied for authorization, as permitted under paragraph (b) of this
section, and the individual remains subject to a behavioral observation
and arrest reporting program that meets the requirements of this part,
beginning on the date upon which the drug and alcohol testing was
conducted through the date upon which the individual is granted
authorization.
(e) Authorization reinstatement after an interruption of 30 or
fewer days. (1) The licensee or other entity need not conduct pre-
access testing before granting authorization to an individual whose
authorization has been interrupted for 5 or fewer days.
(2) In order to reinstate authorization for an individual whose
authorization has been interrupted for a period of more than 5 days but
not more than 30 days, except as permitted in paragraph (e)(3) of this
section, the licensee or other entity shall take the following actions:
(i) The licensee or other entity shall subject the individual to
random selection for pre-access drug and alcohol testing at a one-time
probability that is equal to or greater than the normal testing rate
specified in Sec. 26.31(d)(2)(vi) calculated for a 30-day period;
(ii) If the individual is not selected for pre-access testing under
this paragraph, the licensee or other entity need not perform pre-
access drug and alcohol tests; or
[[Page 50637]]
(iii) If the individual is selected for pre-access testing under
this paragraph, the licensee or other entity shall--
(A) Verify that the individual has negative results from alcohol
testing and collect a specimen for drug testing before reinstating
authorization; and
(B) Verify that the drug test results are negative within 5
business days of specimen collection or administratively withdraw
authorization until negative drug test results are received.
(3) If the individual previously held authorization under this part
and has been subject to both a drug and alcohol testing program that
included random testing and a behavioral observation and arrest
reporting program that meet the requirements of this part from the date
upon which the individual's last authorization was terminated through
the date upon which the individual is granted authorization, then the
granting licensee or other entity need not conduct pre-access testing
of the individual.
(f) Time period for testing. If pre-access testing is required
under this section, the licensee or other entity must collect the
specimens within the 30-day period that precedes the date upon which
the licensee or entity grants authorization to an individual.
(g) Administrative withdrawal of authorization. If a licensee or
other entity administratively withdraws an individual's authorization
under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and
until the drug test results are known, the licensee or other entity may
not record the administrative action to withdraw authorization as an
unfavorable termination. The individual may not be required to disclose
the administrative action in response to requests for self-disclosure
of potentially disqualifying FFD information. Immediately upon receipt
of negative test results, the licensee or other entity shall ensure
that any matter that could link the individual to the temporary
administrative action is eliminated from the tested individual's
personnel record and other records.
(h) Sanctions for a confirmed non-negative pre-access test result.
If an individual has confirmed non-negative test results from any drug,
validity, or alcohol tests that may be required in this section, the
licensee or other entity shall, at a minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec. Sec.
26.75(b), (d), (e)(2), or (g);
(2) Terminate the individual's authorization, if it has been
reinstated, in accordance with Sec. Sec. 26.75(e)(1) or (f); or
(3) Grant authorization to the individual only in accordance with
the requirements of Sec. 26.69.
Sec. 26.67 Random drug and alcohol testing of individuals who have
applied for authorization.
(a) When the licensee or other entity collects specimens from an
individual for any pre-access testing that may be required under
Sec. Sec. 26.65 or 26.69, and thereafter, the licensee or other entity
shall subject the individual to random testing in accordance with Sec.
26.31(d)(2), except if--
(1) The licensee or other entity does not grant authorization to
the individual; or
(2) The licensee or other entity relies upon drug and alcohol tests
to meet the applicable requirements for pre-access testing that were
conducted before the individual applied for authorization. If the
licensee or other entity relies upon drug and alcohol tests that were
conducted before the individual applied for authorization, the licensee
or other entity shall subject the individual to random testing when the
individual arrives at a licensee's or other entity's facility for in-
processing and thereafter.
(b) If an individual is selected for one or more random tests after
any applicable requirement for pre-access testing in Sec. Sec. 26.65
or 26.69 has been met, the licensee or other entity may grant
authorization before random testing is completed in accordance with
Sec. 26.31(d)(2), if the individual has met all other applicable
requirements for authorization.
(c) If an individual has confirmed non-negative test results from
any drug, validity, or alcohol test required in this section, the
licensee or other entity shall, at a minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec. Sec.
26.75(b), (d), (e)(2), or (g);
(2) Terminate the individual's authorization, if it has been
granted, as required by Sec. Sec. 26.75(e)(1) or (f); or
(3) Grant authorization to the individual only in accordance with
the requirements of Sec. 26.69.
Sec. 26.69 Authorization with potentially disqualifying fitness-for-
duty information.
(a) Purpose. This section defines the management actions that
licensees and other entities who are subject to this part shall take in
order to grant or maintain, at the licensee's or other entity's
discretion, the authorization of an individual who is in the following
circumstances:
(1) Potentially disqualifying FFD information within the past 5
years has been disclosed or discovered about the individual by any
means, including, but not limited to, the individual's self-disclosure,
the suitable inquiry, drug and alcohol testing, the administration of
the FFD program, a self-report of a legal action, behavioral
observation, or other sources of information, including, but not
limited to, any background investigation or credit and criminal history
check conducted under the requirements of this chapter; and
(2) The potentially disqualifying FFD information has not been
reviewed and favorably resolved by a previous licensee or other entity
who is subject to this part.
(b) Authorization after a first confirmed positive drug or alcohol
test result or a 5-year denial of authorization. The requirements in
this paragraph apply to individuals whose authorization was denied or
terminated unfavorably for a first violation of an FFD policy involving
a confirmed positive drug or alcohol test result and individuals whose
authorization was denied for 5 years under Sec. 26.75(c), (d), (e)(2),
or (f). In order to grant, and subsequently maintain, the individual's
authorization, the licensee or other entity shall--
(1) Obtain and review a self-disclosure from the individual that
addresses the shorter period of either the past 5 years or since the
individual last held authorization, and verify that the self-disclosure
does not contain any previously undisclosed potentially disqualifying
FFD information before granting authorization;
(2) Complete a suitable inquiry with every employer by whom the
individual claims to have been employed during the period addressed in
the self-disclosure in accordance with the requirements of Sec. 26.63,
and obtain and review any records that other licensees or entities who
are subject to this part may have developed related to the unfavorable
termination or denial of authorization;
(3) If the individual was subject to a 5-year denial of
authorization under this part, verify that he or she has abstained from
substance abuse for at least the past 5 years;
(4) Ensure that an SAE conducts a determination of fitness and
indicates that the individual is fit to safely and competently perform
his or her duties.
(i) If the individual's authorization was denied or terminated
unfavorably for a first confirmed positive drug or alcohol test result,
ensure that clinically appropriate treatment plans are developed by the
SAE before granting authorization;
[[Page 50638]]
(ii) If the individual was subject to a 5-year denial of
authorization, ensure that any recommendations for treatment and
followup testing from the SAE's determination of fitness are initiated
before granting authorization; and
(iii) Verify that the individual is in compliance with, and
successfully completes, any followup testing and treatment plans.
(5) Within 10 business days before granting authorization, perform
a pre-access alcohol test, collect a specimen for drug testing under
direct observation, and ensure that the individual is subject to random
testing thereafter. Verify that the pre-access drug and alcohol test
results are negative before granting authorization.
(6) If the individual's authorization was denied or terminated
unfavorably for a first confirmed positive drug or alcohol test result
and a licensee or other entity grants authorization to the individual,
ensure that the individual is subject to unannounced testing at least
quarterly for a period of 3 calendars years after the date upon which
the individual is again granted authorization. Both random and followup
tests, as defined in Sec. 26.31(c), satisfy this requirement. Verify
that the individual has negative test results from a minimum of 15
tests distributed over the 3-year period, except as follows:
(i) If the individual does not continuously hold authorization
during the 3-year period, the licensee or other entity shall ensure
that at least one unannounced test is conducted in any quarter during
which the individual holds authorization;
(ii) If the 15 tests are not completed within the 3-year period
specified in this paragraph due to periods during which the individual
does not hold authorization, the testing program may be extended up to
5 years to complete the 15 tests;
(iii) If the individual does not hold authorization during the 5-
year period a sufficient number of times or for sufficient periods of
time to complete the 15 tests required in this paragraph, the licensee
or other entity shall ensure that an SAE conducts a determination of
fitness to assess whether further followup testing is required and
implement the SAE's recommendations; and
(7) Verify that any drug and alcohol tests required in this
paragraph, and any other drug and alcohol tests that are conducted
under this part since authorization was terminated or denied, yield
results indicating no further drug abuse, as determined by the MRO
after review, or alcohol abuse, as determined by the result of
confirmatory alcohol testing.
(c) Granting authorization with other potentially disqualifying FFD
information. The requirements in this paragraph apply to an individual
who has applied for authorization, and about whom potentially
disqualifying FFD information has been discovered or disclosed that is
not a first confirmed positive drug or alcohol test result or a 5-year
denial of authorization. Before granting authorization to the
individual, the licensee or other entity shall--
(1) Verify that the individual's self-disclosure and employment
history addresses the applicable period in Sec. 26.61(b)(3);
(2) Complete a suitable inquiry with every employer by whom the
individual claims to have been employed during the period addressed in
the self-disclosure in accordance with the requirements of Sec. 26.63,
and obtain and review any records that other licensees or entities who
are subject to this part may have developed with regard to potentially
disqualifying FFD information about the individual from the past 5
years;
(3) If the designated reviewing official determines that a
determination of fitness is required, verify that a professional with
the appropriate qualifications, as specified in Sec. 26.187(a), has
indicated that the individual is fit to safely and competently perform
his or her duties;
(4) Ensure that the individual is in compliance with, or has
completed, any plans for treatment and drug and alcohol testing from
the determination of fitness, which may include the collection of urine
specimens under direct observation; and
(5) Verify that the results of pre-access drug and alcohol tests
are negative before granting authorization, and that the individual is
subject to random testing after the specimens have been collected for
pre-access testing and thereafter.
(d) Maintaining authorization with other potentially disqualifying
FFD information. If an individual is authorized when other potentially
disqualifying FFD information is disclosed or discovered, in order to
maintain the individual's authorization, the licensee or other entity
shall--
(1) Ensure that the licensee's or other entity's designated
reviewing official completes a review of the circumstances associated
with the information;
(2) If the designated reviewing official concludes that a
determination of fitness is required, verify that a professional with
the appropriate qualifications, as specified in Sec. 26.187(a), has
indicated that the individual is fit to safely and competently perform
his or her duties; and
(3) If the reviewing official determines that maintaining the
individual's authorization is warranted, implement any recommendations
for treatment and followup drug and alcohol testing from the
determination of fitness, which may include the collection of urine
specimens under direct observation, and ensure that the individual
successfully completes the treatment plans.
(e) Accepting followup testing and treatment plans from another
Part 26 program. Licensees and other entities may rely upon followup
testing, treatment plans, and determinations of fitness that were
conducted in accordance with this part by another licensee or entity.
(1) If an individual leaves the FFD program in which a treatment
and followup testing plan was required under paragraphs (b), (c), or
(d) of this section, and is granted authorization by the same or
another licensee or entity, the licensee or other entity who grants
authorization to the individual shall ensure that any treatment and
followup testing requirements are met, with accountability assumed by
the granting licensee or other entity.
(2) If the previous licensee or other entity determined that the
individual successfully completed any required treatment and followup
testing, and the individual's last period of authorization was
terminated favorably, the receiving licensee or entity may rely upon
the previous determination of fitness and no further review or followup
is required.
(f) Sanctions for confirmed non-negative drug and alcohol test
results. If an individual has confirmed non-negative test results from
any drug, validity, or alcohol test required in this section, the
licensee or other entity shall, at a minimum and as appropriate--
(1) Deny authorization to the individual, as required by Sec. Sec.
26.75(b), (d), (e)(2), or (g); or
(2) Terminate the individual's authorization, if it has been
granted, as required by Sec. Sec. 26.75(e)(1) or (f).
Sec. 26.71 Maintaining authorization.
(a) Individuals may maintain authorization under the following
conditions:
(1) The individual complies with the licensee's or other entity's
FFD policies to which he or she is subject, including the
responsibility to report any legal actions, as defined in Sec. 26.5;
(2) The individual remains subject to a drug and alcohol testing
program that
[[Page 50639]]
complies with the requirements of this part, including random testing;
(3) The individual remains subject to a behavioral observation
program that complies with the requirements of this part; and
(4) The individual successfully completes required FFD training, in
accordance with the schedule specified in Sec. 26.29(c).
(b) If an authorized individual is not subject to an FFD program
that meets the requirements of this part for more than 30 continuous
days, then the licensee or other entity shall terminate the
individual's authorization and the individual shall meet the
requirements in this subpart, as applicable, to regain authorization.
Subpart D--Management Actions and Sanctions to be Imposed
Sec. 26.75 Sanctions.
(a) This section defines the minimum sanctions that licensees and
other entities shall impose when an individual has violated the drug
and alcohol provisions of an FFD policy. A licensee or other entity who
is subject to this part may impose more stringent sanctions, except as
specified in paragraph (h) of this section.
(b) Any act or attempted act to subvert the testing process,
including, but not limited to, refusing to provide a specimen and
providing or attempting to provide a substituted or adulterated
specimen, for any test required under this part must result in the
immediate unfavorable termination of the individual's authorization and
permanent denial of authorization thereafter.
(c) Any individual who is determined to have been involved in the
sale, use, or possession of illegal drugs or the consumption of alcohol
within a protected area of any nuclear power plant, within a facility
that is licensed to possess or use formula quantities of SSNM, within a
transporter's facility or vehicle, or while performing the job duties
that require the individual to be subject to this part shall
immediately have his or her authorization unfavorably terminated and
denied thereafter for a minimum of 5 years from the date of the
unfavorable termination of authorization.
(d) Any individual who resigns or withdraws his or her application
for authorization before authorization is terminated or denied for a
first violation of the FFD policy involving a confirmed positive drug
or alcohol test result shall immediately have his or her authorization
denied for a minimum of 5 years from the date of termination or denial.
If an individual resigns or withdraws his or her application for
authorization before his or her authorization is terminated or denied
for any violation of the FFD policy, the licensee or other entity shall
record the resignation or withdrawal, the nature of the violation, and
the minimum sanction that would have been required under this part had
the individual not resigned or withdrawn his or her application for
authorization.
(e) Lacking any other evidence to indicate the use, sale, or
possession of illegal drugs or consumption of alcohol on site, a
confirmed positive drug or alcohol test result must be presumed to be
an indication of off-site drug or alcohol use in violation of the FFD
policy.
(1) The first violation of the FFD policy involving a confirmed
positive drug or alcohol test result must, at a minimum, result in the
immediate unfavorable termination of the individual's authorization for
at least 14 days.
(2) Any subsequent confirmed positive drug or alcohol test result,
including during an assessment or treatment period, must result in the
denial of authorization for a minimum of 5 years from the date of
denial.
(f) Paragraph (e) of this section does not apply to the misuse of
prescription and over-the-counter drugs, except if the MRO determines
that misuse of the prescription or over-the-counter drug represents
substance abuse. Sanctions for misuse of prescription and over-the-
counter drugs must be sufficient to deter misuse of those substances.
(g) For individuals whose authorization was denied for 5 years
under paragraphs (c), (d), (e), or (f) of this section, any subsequent
violation of the drug and alcohol provisions of an FFD policy must
immediately result in permanent denial of authorization.
(h) A licensee or other entity who is subject to this part may not
terminate an individual's authorization and may not subject the
individual to other administrative action based solely on a non-
negative test result from any validity screening, initial validity, or
initial drug test, other than positive initial test results for
marijuana or cocaine metabolites from a specimen that appears to be
valid on the basis of either validity screening or initial validity
testing performed at a licensee testing facility, unless other
evidence, including information obtained under the process set forth in
Sec. 26.189, indicates that the individual is impaired or might
otherwise pose a safety hazard.
(i) With respect to initial drug test results from a licensee
testing facility for marijuana and cocaine metabolites from a specimen
that appears to be valid, licensee testing facility personnel may
inform licensee or other entity management of the non-negative initial
drug test result and the specific drugs or metabolites identified, and
licensees or other entities may administratively withdraw the donor's
authorization or take lesser administrative actions against the donor
based on a positive initial drug test result from a specimen that
appears to be valid, provided that the licensee or other entity
complies with the following conditions:
(1) For the drug for which action will be taken, at least 85
percent of the specimens that were determined to be positive as a
result of initial drug tests at the licensee testing facility during
the past 12-month data reporting period submitted to the NRC under
Sec. 26.217 were subsequently reported as positive by the HHS-
certified laboratory as the result of confirmatory testing;
(2) There is no loss of compensation or benefits to the donor
during the period of temporary administrative action;
(3) Immediately upon receipt of a negative report from the HHS-
certified laboratory or MRO, any matter that could link the donor to
the temporary administrative action is eliminated from the donor's
personnel record and other records; and
(4) Licensees and other entities may not disclose the temporary
administrative action against an individual whose initial drug test
result is not subsequently confirmed by the MRO as a violation of the
FFD policy in response to a suitable inquiry conducted under the
provisions of Sec. 26.63, a background investigation conducted under
the provisions of this chapter, or to any other inquiry or
investigation.
(i) To ensure that no records are retained, access to the system of
files and records must be provided to personnel who are conducting
reviews, inquiries into allegations, or audits under the provisions of
Sec. 26.41, and to NRC inspectors.
(ii) The licensee or other entity shall provide the donor with a
written statement that the records specified in Sec. 26.213 and Sec.
26.215 have not been retained with respect to the temporary
administrative action and shall inform the donor in writing that the
temporary administrative action that was taken will not be disclosed
and need not be disclosed by the individual in response to requests for
self-disclosure of potentially disqualifying FFD information.
[[Page 50640]]
Sec. 26.77 Management actions regarding possible impairment.
(a) This section defines management actions that licensees and
other entities must take when an individual who is subject to this part
shows indications that he or she may not be fit to safely and
competently perform his or her duties.
(b) If an individual appears to be impaired or the individual's
fitness is questionable, except as permitted under Sec. 26.27(c)(3)
and Sec. 26.199(e) and (f), the licensee or other entity shall take
immediate action to prevent the individual from performing the job
duties that require him or her to be subject to this part.
(1) If an observed behavior or physical condition creates a
reasonable suspicion of possible substance abuse, the licensee or other
entity shall perform drug and alcohol tests and the results must be
negative before the individual returns to performing the job duties
that require the individual to be subject to this part. However, if the
physical condition is the smell of alcohol with no other behavioral or
physical indications of impairment, then only an alcohol test is
required, and the results must be negative before the individual
returns to performing his or her duties.
(2) If a licensee or C/V who is subject to Subpart I is certain
that the observed behavior or physical condition is the result solely
of fatigue, the licensee or C/V shall ensure that a fatigue assessment
is conducted in accordance with Sec. 26.201 and need not perform drug
and alcohol tests nor a determination of fitness under Sec. 26.189.
(3) For other indications of possible impairment that do not create
a reasonable suspicion of substance abuse (or fatigue, in the case of
licensees and C/Vs who are subject to Subpart I), the licensee or other
entity may permit the individual to return to performing his or her job
duties only after the impairing or questionable conditions are resolved
and a determination of fitness indicates that the individual is fit to
safely and competently perform his or her duties.
(c) If a licensee or other entity has a reasonable belief that an
NRC employee or NRC contractor may be under the influence of any
substance, or is otherwise unfit for duty, the licensee or other entity
may not deny access but shall escort the individual. In any such
instance, the licensee or other entity shall immediately notify the
appropriate Regional Administrator by telephone, followed by written
notification (e.g., e-mail or fax) to document the verbal notification.
If the Regional Administrator cannot be reached, the licensee or other
entity shall notify the NRC Operations Center.
Subpart E--Collecting Specimens for Testing
Sec. 26.81 Purpose.
This subpart contains requirements for collecting specimens for
drug and alcohol testing.
Sec. 26.83 Specimens to be collected.
Except as permitted under Sec. 26.31(d)(5), licensees and other
entities who are subject to this part shall--
(a) Collect either breath or oral fluids for initial tests for
alcohol. Breath must be collected for confirmatory tests for alcohol;
and
(b) Collect only urine specimens for both initial and confirmatory
tests for drugs.
Sec. 26.85 Collector qualifications and responsibilities.
(a) Urine collector qualifications. Urine collectors shall be
knowledgeable of the requirements of this part, the FFD policy and
procedures of the licensee or other entity for whom collections are
performed, and shall keep current on any changes to urine collection
procedures. Collectors shall receive qualification training that meets
the requirements of this paragraph and demonstrate proficiency in
applying the requirements of this paragraph before serving as a
collector. At a minimum, qualification training must provide
instruction on the following subjects:
(1) All steps necessary to complete a collection correctly and the
proper completion and transmission of the custody-and-control form;
(2) Methods to address ``problem'' collections, including, but not
limited to, collections involving ``shy bladder'' and attempts to
tamper with a specimen;
(3) How to correct problems in collections; and
(4) The collector's responsibility for maintaining the integrity of
the specimen collection and transfer process, carefully ensuring the
modesty and privacy of the donor, and avoiding any conduct or remarks
that might be construed as accusatorial or otherwise offensive or
inappropriate.
(b) Alcohol collector qualifications. Alcohol collectors shall be
knowledgeable of the requirements of this part, the FFD policy and
procedures of the licensee or other entity for whom collections are
performed, and shall keep current on any changes to alcohol collection
procedures. Collectors shall receive qualification training meeting the
requirements of this paragraph and demonstrate proficiency in applying
the requirements of this paragraph before serving as a collector. At a
minimum, qualification training must provide instruction on the
following subjects:
(1) The alcohol testing requirements of this part;
(2) Operation of the particular alcohol testing device(s) [i.e.,
the alcohol screening devices (ASDs) or evidential breath testing
devices (EBTs)] to be used, consistent with the most recent version of
the manufacturers' instructions;
(3) Methods to address ``problem'' collections, including, but not
limited to, collections involving ``shy lung'' and attempts to tamper
with a specimen;
(4) How to correct problems in collections; and
(5) The collector's responsibility for maintaining the integrity of
the specimen collection process, carefully ensuring the privacy of the
donor, and avoiding any conduct or remarks that might be construed as
accusatorial or otherwise offensive or inappropriate.
(c) Alternative collectors. A medical professional, technologist,
or technician may serve as a collector without meeting the collector
qualification requirements in paragraphs (a) or (b) of this section, as
applicable, if the individual's normal workplace is not at the
licensee's or other entity's facility and he or she--
(1) Is not employed by the licensee's or other entity's FFD
program;
(2) Does not routinely provide FFD program services to the licensee
or other entity;
(3) Is licensed or otherwise approved to practice in the
jurisdiction in which the collection occurs;
(4) Is provided with detailed, clearly-illustrated, written
instructions for collecting specimens in accordance with this subpart;
and
(5) Performs collections in accordance with those instructions.
(d) Personnel available to testify at proceedings. The licensee or
other entity shall ensure that qualified collection site personnel,
when required, are available to testify in an administrative or
disciplinary proceeding against an individual when that proceeding is
based on non-negative alcohol, validity, or drug test results from
specimens collected by or under contract to the licensee or other
entity.
Sec. 26.87 Collection sites.
(a) Each FFD program must have one or more designated collection
sites that have all necessary personnel, materials, equipment,
facilities, and supervision to collect specimens for drug testing and
to
[[Page 50641]]
perform alcohol testing. Each collection site must provide for the
collection, security, temporary storage, and shipping or transportation
of urine specimens to a drug testing laboratory, and for the collection
of oral fluids or breath specimens, and the security of alcohol testing
devices and test results. A properly equipped mobile facility that
meets the requirements of this part is an acceptable collection site.
(b) The collection site must provide for the donor's visual privacy
while the donor and collector are viewing the results of an alcohol
test, and for individual privacy while the donor is submitting a urine
specimen, except if a directly observed urine specimen collection is
required. Unauthorized personnel may not be present for the specimen
collection.
(c) Contracts for collection site services must permit
representatives of the NRC, licensee, or other entity to conduct
unannounced inspections and audits and to obtain all information and
documentation that is reasonably relevant to the inspections and
audits.
(d) Licensees and other entities shall take the following measures
to prevent unauthorized access to the collection site that could
compromise the integrity of the collection process or the specimens.
(1) Unauthorized personnel may not be permitted in any part of the
designated collection site where specimens are collected or stored;
(2) A designated collection site must be secure. If a collection
site is dedicated solely to specimen collection, it must be secure at
all times. Methods of assuring security may include, but are not
limited to, physical measures to control access, such as locked doors,
alarms, or visual monitoring of the collection site when it is not
occupied; and
(3) If a collection site cannot be dedicated solely to collecting
specimens, the portion of the facility that is used for specimen
collection must be secured and, during the time period during which a
specimen is being collected, a sign must be posted to indicate that
access is permitted only for authorized personnel.
(e) The following steps must be taken to deter the dilution and
adulteration of urine specimens at the collection site:
(1) Agents that color any source of standing water in the stall or
room in which the donor will provide a specimen, including, but not
limited to, the toilet bowl or tank, must be placed in the source of
standing water, so that the reservoirs of water are neither yellow nor
colorless. Coloring agents may not interfere with drug or validity
tests;
(2) There must be no other source of water (e.g., no shower or
sink) in the enclosure where urination occurs, or the source of water
must be rendered unusable; and
(3) Chemicals or products that could be used to contaminate or
otherwise alter the specimen must be removed from the collection site
or secured. The collector shall inspect the enclosure in which
urination will occur before each collection to ensure that no materials
are available that could be used to subvert the testing process.
(f) In the exceptional event that a designated collection site is
inaccessible and there is an immediate requirement to collect a urine
specimen, including, but not limited to, an event investigation, then
the licensee or other entity may use a public rest room, on-site rest
room, or hospital examining room according to the following procedures:
(1) The facility must be secured by visual inspection to ensure
that no unauthorized persons are present, and that undetected access
(e.g., through a rear door not in the view of the collector) is
impossible. Security during the collection may be maintained by
restricting access to collection materials and specimens. In the case
of a public rest room, a sign must be posted or an individual assigned
to ensure that no unauthorized personnel are present during the entire
collection procedure to avoid embarrassment of the donor and
distraction of the collector.
(2) If practical, a water coloring agent that meets the
requirements of Sec. 26.87(e)(1) must be placed in the toilet bowl to
be used by the donor and in any other accessible source of standing
water, including, but not limited to, the toilet tank. The collector
shall instruct the donor not to flush the toilet.
(3) A collector of the same gender as the donor shall accompany the
donor into the area that will be used for specimen collection, but
remain outside of the stall, if it is a multi-stalled rest room, or
outside of the door to the room, if it is a single rest room, in which
the donor will provide the specimen. If a collector of the same gender
is not available, the collector shall select a same-gender person to
accompany the donor. This person shall be instructed on the collection
procedures specified in this subpart and his or her identity must be
documented on the custody-and-control form.
(4) After the collector has possession of the specimen, the
collector shall inspect the toilet bowl and area to ensure that there
is no evidence of a subversion attempt and shall then flush the toilet.
The collector shall instruct the donor to participate with the
collector in completing the chain-of-custody procedures.
(5) If it is impractical to maintain continuous physical security
of a collection site from the time a urine specimen is presented until
the sealed container is transferred for shipment, the specimen must
remain under the direct control of an individual who is authorized by
the licensee or other entity until the specimen is prepared for
transfer, storage, or shipping in accordance with Sec. 26.117. The
authorized individual shall be instructed on his or her
responsibilities for maintaining custody and control of the specimen
and his or her custody of the specimen must be documented on the
custody-and-control form.
Sec. 26.89 Preparing to collect specimens for testing.
(a) When an individual has been notified of a requirement for
testing and does not appear at the collection site within the time
period specified by FFD program procedures, the collector shall inform
FFD program management that the individual has not reported for
testing. FFD program management shall ensure that the necessary steps
are taken to determine whether the individual's undue tardiness or
failure to appear for testing constitutes a violation of the licensee's
or other entity's FFD policy. If FFD program management determines that
the undue tardiness or failure to report for testing represents an
attempt to subvert the testing process, the licensee or other entity
shall impose on the individual the sanctions in Sec. 26.75(b). If FFD
program management determines that the undue tardiness or failure to
report does not represent a subversion attempt, the licensee or other
entity may not impose sanctions but shall ensure that the individual is
tested at the earliest reasonable and practical opportunity after
locating the individual.
(b) Donors shall provide acceptable identification before testing.
(1) Acceptable identification includes photo-identification issued
by a licensee or other entity who is subject to this part, or by the
Federal, State, or local government. Licensees and other entities may
not accept faxes or photocopies of identification.
(2) If the donor cannot produce acceptable identification before
any testing that is required under this part other than pre-access
testing, the collector shall proceed with the test and immediately
inform FFD program management that the donor did not
[[Page 50642]]
present acceptable identification. If the donor is scheduled for pre-
access testing and cannot produce acceptable identification, the
collector may not proceed with the collection, and shall inform FFD
program management that the individual did not present acceptable
identification. When so informed, FFD program management will take the
necessary steps to determine whether the lack of identification was an
attempt to subvert the testing process.
(3) The collector shall explain the testing procedure to the donor,
show the donor the form(s) to be used, and ask the donor to sign a
consent-to-testing form. The donor may not be required to list
prescription medications or over-the-counter preparations that he or
she has recently used.
(c) The collector shall inform the donor that, if the donor leaves
the collection site before all of the collection procedures are
completed or refuses to cooperate in the specimen collection process,
it will be considered a refusal to test, and sanctions for subverting
the testing process will be imposed in accordance with Sec. 26.75(b).
If the donor fails to remain present through the completion of the
collection procedures or refuses to cooperate in the collection
procedures, the collector shall inform FFD program management to obtain
guidance on the actions to be taken.
(d) In order to promote the security of specimens, avoid
distraction of the collector, and ensure against any confusion in the
identification of specimens, a collector shall conduct only one
collection procedure at any given time. For this purpose, a urine
collection procedure is complete when the urine specimen container has
been sealed and initialed, the chain-of-custody form has been executed,
and the donor has departed the collection site.
Sec. 26.91 Acceptable devices for conducting initial and confirmatory
tests for alcohol and methods of use.
(a) Acceptable alcohol screening devices. Alcohol screening devices
(ASDs), including devices that test specimens of oral fluids or breath,
must be approved by the National Highway Traffic Safety Administration
(NHTSA) and listed in the most current version of NHTSA's Conforming
Products List (CPL) for such devices. An ASD that is listed in the
NHTSA CPL may be used only for initial tests for alcohol, and may not
be used for confirmatory tests.
(b) Acceptable evidential breath testing devices. Evidential breath
testing devices (EBTs) listed in the NHTSA CPL for evidential devices
that meet the requirements of paragraph (c) of this section must be
used to conduct confirmatory alcohol tests, and may be used to conduct
initial alcohol tests. Note that, among the devices listed in the CPL
for EBTs, only those devices listed without an asterisk (*) may be used
for confirmatory alcohol testing under this part.
(c) EBT capabilities. An EBT that is listed in the NHTSA CPL for
evidential devices that has the following capabilities may be used for
conducting initial alcohol tests and must be used for confirmatory
alcohol tests under this part:
(1) Provides a printed result of each breath test;
(2) Assigns a unique number to each completed test, which the
collector and donor can read before each test and which is printed on
each copy of the test result;
(3) Prints, on each copy of the test result, the manufacturer's
name for the device, its serial number, and the time of the test;
(4) Distinguishes alcohol from acetone at the 0.02 alcohol
concentration level;
(5) Tests an air blank; and
(6) Performs an external calibration check.
(d) Quality assurance and quality control of ASDs. (1) Licensees
and other entities shall implement the most recent version of the
quality assurance plan submitted to NHTSA for any ASD that is used for
initial alcohol testing.
(2) Licensees and other entities may not use an ASD that fails the
specified quality control checks or that has passed its expiration
date.
(3) For ASDs that test breath specimens and meet EBT requirements
for confirmatory testing, licensees and other entities shall also
follow the device use and care requirements specified in paragraph (e)
of this section.
(e) Quality assurance and quality control of EBTs. (1) Licensees
and other entities shall implement the most recent version of the
manufacturer's instructions for the use and care of the EBT
consistently with the quality assurance plan submitted to NHTSA for the
EBT, including performing external calibration checks no less
frequently than at the intervals specified in the manufacturer's
instructions.
(2) When conducting external calibration checks, licensees and
other entities shall use only calibration devices appearing on NHTSA's
CPL for ``Calibrating Units for Breath Alcohol Tests.''
(3) If an EBT fails an external check of calibration, the licensee
or other entity shall take the EBT out of service and cancel every
positive test result that was obtained using the EBT from any tests
that were conducted after the EBT passed the last external calibration
check. The EBT may not be used again for alcohol testing under this
part until it is repaired and passes an external calibration check.
(4) Inspection, maintenance, and calibration of the EBT must be
performed by its manufacturer or a maintenance representative certified
either by the manufacturer or by a State health agency or other
appropriate State agency.
Sec. 26.93 Preparing for alcohol testing.
(a) Immediately before collecting a specimen for alcohol testing,
the collector shall--
(1) Ask the donor whether he or she, in the past 15 minutes, has
had anything to eat or drink, belched, or put anything into his or her
mouth (including, but not limited to, a cigarette, breath mint, or
chewing gum), and instruct the donor that he or she should avoid these
activities during the collection process;
(2) If the donor states that he or she has not engaged in the
activities listed in paragraph (a)(1) of this section, alcohol testing
may proceed;
(3) If the donor states that he or she has engaged in any of the
activities listed in paragraph (a)(1) of this section, inform the donor
that a 15-minute waiting period is necessary to prevent an accumulation
of mouth alcohol from leading to an artificially high reading;
(4) Explain that it is to the donor's benefit to avoid the
activities listed in paragraph (a)(1) of this section during the
collection process;
(5) Explain that the initial and confirmatory tests, if a
confirmatory test is necessary, will be conducted at the end of the
waiting period, even if the donor has not followed the instructions;
and
(6) Document that the instructions were communicated to the donor.
(b) With the exception of the 15-minute waiting period, if
necessary, the collector shall begin for-cause alcohol and/or drug
testing as soon as reasonably practical after the decision is made that
for-cause testing is required. When for-cause alcohol testing is
required, alcohol testing may not be delayed by collecting a specimen
for drug testing.
Sec. 26.95 Conducting an initial test for alcohol using a breath
specimen.
(a) The collector shall perform the initial breath test as soon as
practical after the donor indicates that he or she has not engaged in
the activities listed
[[Page 50643]]
in paragraph Sec. 26.93(a)(1) or after the 15-minute waiting period
has elapsed, if required.
(b) To perform the initial test, the collector shall--
(1) Select, or allow the donor to select, an individually wrapped
or sealed mouthpiece from the testing materials;
(2) Open the individually wrapped or sealed mouthpiece in view of
the donor and insert it into the device in accordance with the
manufacturer's instructions;
(3) Instruct the donor to blow steadily and forcefully into the
mouthpiece for at least 6 seconds or until the device indicates that an
adequate amount of breath has been obtained;
(4) Show the donor the displayed or printed test result; and
(5) Ensure that the test result record can be associated with the
donor and is maintained secure.
(c) Unless problems in administering the breath test require an
additional collection, only one breath specimen may be collected for
the initial test. If an additional collection(s) is required, the
collector shall rely upon the test result from the first successful
collection to determine the need for confirmatory testing.
Sec. 26.97 Conducting an initial test for alcohol using a specimen of
oral fluids.
(a) To perform the initial test, the collector shall--
(1) Check the expiration date on the device and show it to the
donor (the device may not be used after its expiration date);
(2) Open an individually wrapped or sealed package containing the
device in the presence of the donor;
(3) Offer the donor the choice of using the device or having the
collector use it. If the donor chooses to use it, instruct the donor to
insert the device into his or her mouth and use it in the manner
described by the device's manufacturer;
(4) If the donor chooses not to use the device, or in all cases in
which a new test is necessary because the device failed to activate,
insert the device into the donor's mouth, and gather oral fluids in the
manner described by the device's manufacturer (wear single-use
examination or similar gloves while doing so and change them following
each test); and
(5) When the device is removed from the donor's mouth, follow the
manufacturer's instructions regarding necessary next steps to ensure
that the device has activated.
(b) If the steps in paragraph (a) of this section could not be
completed successfully (e.g., the device breaks, the device is dropped
on the floor, the device fails to activate), the collector shall--
(1) Discard the device and conduct a new test using a new device.
The new device must be one that has been under the collector's control
before the test;
(2) Record the reason for the new test;
(3) Offer the donor the choice of using the device or having the
collector use it unless the donor, in the opinion of the collector, was
responsible for the new test needing to be conducted. If the collector
concludes that the donor was responsible, then the collector shall use
the device to conduct the test; and
(4) Repeat the procedures in paragraph (a) of this section.
(c) If the second collection attempt in paragraph (b) of this
section could not be completed, the collector shall--
(1) End the collection of oral fluids and document the reason(s)
that the collection could not be completed; and
(2) Immediately conduct another initial test using an EBT.
(d) The collector shall read the result displayed on the device no
sooner than the device's manufacturer instructs. In all cases, the
collector shall read the result within 15 minutes of the test. The
collector shall then show the device and its reading to the donor,
record the result, and record that an ASD was used.
(e) Devices, swabs, gloves, and other materials used in collecting
oral fluids may not be re-used.
Sec. 26.99 Determining the need for a confirmatory test for alcohol.
(a) If the initial test result is less than 0.02 percent BAC, the
collector shall declare the test result as negative.
(b) If the initial test result is 0.02 percent BAC or higher, the
collector shall ensure that the time at which the test was concluded
(i.e., the time at which the test result was known) is recorded and
inform the donor that a confirmatory test for alcohol is required.
Sec. 26.101 Conducting a confirmatory test for alcohol.
(a) The confirmatory test must begin as soon as possible, but no
more than 30 minutes after the conclusion of the initial test.
(b) To complete the confirmatory test, the collector shall--
(1) In the presence of the donor, conduct an air blank on the EBT
before beginning the confirmatory test and show the result to the
donor;
(2) Verify that the reading is 0.00. If the reading is 0.00, the
test may proceed. If not, then conduct another air blank;
(3) If the reading on the second air blank is 0.00, the test may
proceed. If the reading is greater than 0.00, take the EBT out of
service and proceed with the test using another EBT. If an EBT is taken
out of service for this reason, the EBT may not be used for further
testing until it is found to be within tolerance limits on an external
check of calibration;
(4) Open an individually wrapped or sealed mouthpiece in view of
the donor and insert it into the device in accordance with the
manufacturer's instructions;
(5) Read the unique test number displayed on the EBT, and ensure
that the donor reads the same number;
(6) Instruct the donor to blow steadily and forcefully into the
mouthpiece for at least 6 seconds or until the device indicates that an
adequate amount of breath has been obtained; and
(7) Show the donor the result displayed on or printed by the EBT,
record the result, and document the time at which the confirmatory test
result was known.
(c) Unless there are problems in administering the breath test that
require an additional collection, the collector shall collect only one
breath specimen for the confirmatory test. If an additional
collection(s) is required because of problems in administering the
breath test, the collector shall rely upon the breath specimen from the
first successful collection to determine the confirmatory test result.
Collection procedures may not require collectors to calculate an
average or otherwise combine results from two or more breath specimens
to determine the confirmatory test result.
(d) If an EBT that meets the requirements of Sec. 26.91(b) and (c)
was used for the initial alcohol test, the same EBT may be used for
confirmatory testing.
Sec. 26.103 Determining a confirmed positive test result for alcohol.
(a) A confirmed positive test result for alcohol must be declared
under any of the following conditions:
(1) When the result of the confirmatory test for alcohol is 0.04
percent BAC or higher;
(2) When the result of the confirmatory test for alcohol is 0.03
percent BAC or higher and the donor had been in a work status for at
least 1 hour at the time the initial test was concluded (including any
breaks for rest, lunch, dental/doctor appointments, etc.); or
(3) When the result of the confirmatory test for alcohol is 0.02
percent BAC or higher and the donor had been in a work status for at
least 2 hours at the time the initial test was
[[Page 50644]]
concluded (including any breaks for rest, lunch, dental/doctor
appointments, etc.).
(b) When the result of the confirmatory test for alcohol is equal
to or greater than 0.01 percent BAC but less than 0.02 percent BAC and
the donor has been in a work status for 3 hours or more at the time the
initial test was concluded (including any breaks for rest, lunch,
dental/doctor appointments, etc.), the collector shall declare the test
result as negative and inform FFD program management. The licensee or
other entity shall prohibit the donor from performing any duties that
require him or her to be subject to this part and may not return the
individual to performing such duties until a determination of fitness
indicates that the donor is fit to safely and competently perform his
or her duties.
Sec. 26.105 Preparing for urine collection.
(a) The collector shall ask the donor to remove any unnecessary
outer garments, such as a coat or jacket, which might conceal items or
substances that the donor could use to tamper with or adulterate his or
her urine specimen. The collector shall ensure that all personal
belongings such as a purse or briefcase remain with the outer garments
outside of the room or stall in which the urine specimen is collected.
The donor may retain his or her wallet.
(b) The collector shall also ask the donor to empty his or her
pockets and display the items in them to enable the collector to
identify items that the donor could use to adulterate or substitute his
or her urine specimen. The donor shall permit the collector to make
this observation. If the donor refuses to show the collector the items
in his or her pockets, this is considered a refusal to test. If an item
is found that appears to have been brought to the collection site with
the intent to adulterate the specimen, the collector shall contact the
MRO or FFD program manager to determine whether a directly observed
collection is required. If the item appears to have been inadvertently
brought to the collection site, the collector shall secure the item and
continue with the normal collection procedure. If the collector
identifies nothing that the donor could use to adulterate or substitute
the specimen, the donor may place the items back into his or her
pockets.
(c) The collector shall instruct the donor to wash and dry his or
her hands before urinating.
(d) After washing his or her hands, the donor shall remain in the
presence of the collector and may not have access to any water
fountain, faucet, soap dispenser, cleaning agent, or other materials
that he or she could use to adulterate the urine specimen.
(e) The collector may select, or allow the donor to select, an
individually wrapped or sealed collection container from the collection
kit materials. Either the collector or the donor, with both present,
shall unwrap or break the seal of the collection container. With the
exception of the collection container, the donor may not take anything
from the collection kit into the room or stall used for urination.
Sec. 26.107 Collecting a urine specimen.
(a) The collector shall direct the donor to go into the room or
stall used for urination, provide a specimen of the quantity that has
been predetermined by the licensee or other entity, as defined in Sec.
26.109(a), not flush the toilet, and return with the specimen as soon
as the donor has completed the void.
(1) The donor shall provide his or her urine specimen in the
privacy of a room, stall, or otherwise partitioned area (private area)
that allows for individual privacy, except if a directly observed
collection is required, as described in Sec. 26.115;
(2) Except in the case of a directly observed collection, no one
may go with the donor into the room or stall in which the donor will
provide his or her specimen; and
(3) The collector may set a reasonable time limit for voiding.
(b) The collector shall pay careful attention to the donor during
the entire collection process to note any conduct that clearly
indicates an attempt to tamper with a specimen (e.g., substitute urine
is in plain view or an attempt to bring an adulterant or urine
substitute into the private area used for urination). If any such
conduct is detected, the collector shall document the conduct on the
custody-and-control form and contact FFD program management to
determine whether a directly observed collection is required, as
described in Sec. 26.115.
(c) After the donor has provided the urine specimen and submitted
it to the collector, the donor shall be permitted to wash his or her
hands. The collector shall inspect the toilet bowl and room or stall in
which the donor voided to identify any evidence of a subversion
attempt, and then flush the toilet.
Sec. 26.109 Urine specimen quantity.
(a) Licensees and other entities who are subject to this part shall
establish a predetermined quantity of urine that donors are requested
to provide when submitting a specimen. At a minimum, the predetermined
quantity must include 30 milliliters (mL) to ensure that a sufficient
quantity of urine is available for initial and confirmatory validity
and drug tests at an HHS-certified laboratory, and for retesting of an
aliquot of the specimen if requested by the donor in accordance with
Sec. 26.165(b). The licensee's or other entity's predetermined
quantity may include more than 30 mL, if the testing program follows
split specimen procedures, tests for additional drugs, or performs
initial testing at a licensee testing facility. Where collected
specimens are to be split under the provisions of this part, the
predetermined quantity must include an additional 15 mL.
(b) If the quantity of urine in the first specimen provided by the
donor is less than 30 mL, the collector shall take the following steps:
(1) The collector shall encourage the donor to drink a reasonable
amount of liquid (normally, 8 ounces of water every 30 minutes, but not
to exceed a maximum of 24 oz. over 3 hours) until the donor provides a
specimen containing at least 30 mL. The collector shall provide the
donor with a separate collection container for each successive
specimen;
(2) Once the donor provides a specimen of at least 30 mL, the
collection must end. If the specimen is at least 30 mL but is less than
the licensee's or other entity's predetermined quantity, the licensee
or other entity may not require the donor to provide additional
specimens and may not impose any sanctions on the donor. If the donor
provides a specimen of 30 mL or more, but the specimen is less than the
predetermined quantity, the collector shall forward the specimen to the
HHS-certified laboratory for testing. If the donor provides a specimen
of at least the predetermined quantity, the specimen may be processed
in accordance with the FFD program's usual testing procedures;
(3) If the donor has not provided a specimen of at least 30 mL
within 3 hours of the first unsuccessful attempt to provide a specimen
of the predetermined quantity, the collector shall discontinue the
collection and notify the FFD program manager or MRO to initiate the
``shy bladder'' procedures in Sec. 26.119; and
(4) Neither the donor nor the collector may combine specimens. The
collector shall discard specimens of less than 30 mL, except if there
is reason to believe that the donor has diluted, adulterated,
substituted, or otherwise tampered with the specimen, based upon the
collector's observations of the donor's behavior during the collection
process or the
[[Page 50645]]
specimen's characteristics, as specified in Sec. 26.111. If the
collector has a reason to believe that a specimen that is 15 mL or
more, but less than 30 mL, has been diluted, adulterated, substituted,
or altered, the collector shall prepare the suspect specimen for
shipping to the HHS-certified laboratory and contact FFD program
management to determine whether a directly observed collection is
required, as described in Sec. 26.115.
Sec. 26.111 Checking the validity of the urine specimen.
(a) Immediately after the donor provides the urine specimen to the
collector, including specimens of less than 30 mL but greater than 15
mL, the collector shall measure the temperature of the specimen. The
temperature-measuring device used must accurately reflect the
temperature of the specimen and not contaminate the specimen. The time
from urination to temperature measurement may not exceed 4 minutes, and
may need to be less if the ambient temperature is low or the specimen
quantity is less than 30 mL.
(b) If the temperature of a urine specimen is outside the range of
90 [deg]F to 100 [deg]F, the collector shall inform the donor that he
or she may volunteer to have his or her temperature taken to provide
evidence to counter the reason to believe the donor may have altered or
substituted the specimen.
(c) Immediately after the donor provides a urine specimen,
including specimens of less than 30 mL but greater than 15 mL, the
collector shall also inspect the specimen to determine its color and
clarity and look for any signs of contaminants or adulteration. The
collector shall note any unusual findings on the custody-and-control
form.
(d) If there is reason to believe that the donor may have attempted
to dilute, substitute, or adulterate the specimen based upon specimen
temperature or other observations made during the collection, the
collector shall contact the designated FFD program manager, who may
consult with the MRO, to determine whether the donor has attempted to
subvert the testing process or whether other circumstances may explain
the observations. The FFD program manager or MRO may require the donor
to provide a second specimen as soon as possible, including under
direct observation.
(e) Any specimen of 15 mL or more that the collector suspects has
been diluted, substituted, or adulterated must be sent directly to the
HHS-certified laboratory for initial and confirmatory testing, if
required, and may not be subject to initial testing at a licensee
testing facility.
(f) As much of the suspect specimen as possible must be preserved.
(g) An acceptable specimen is free of any apparent contaminants,
meets the required basic quantity of at least 30 mL, and is within the
acceptable temperature range.
Sec. 26.113 Splitting the urine specimen.
(a) Licensees and other entities who are subject to this part may,
but are not required to, use split-specimen methods of collection.
(b) If the urine specimen is to be split into two specimen bottles,
hereinafter referred to as Bottle A and Bottle B, the collector shall
take the following steps:
(1) The collector shall instruct the donor to urinate into either a
specimen bottle or a specimen container;
(2) The collector, in the presence of the donor and after
determining specimen temperature as described in Sec. 26.111(a), shall
split the urine specimen. Bottle A must contain a minimum of 30 mL of
urine and Bottle B must contain 15 mL. The Bottle A specimen must be
used for drug and validity testing at the HHS-certified laboratory. If
there is less than 15 mL of urine available for Bottle B, the specimen
in Bottle A must nevertheless be processed for testing; and
(3) The collector shall ask the donor to observe the splitting of
the urine specimen and to maintain visual contact with both specimen
bottles until the custody-and-control form(s) for both specimens are
completed, the specimens are sealed, and the specimens and form(s) are
prepared for secure storage or shipping.
(c) Licensees and other entities may use aliquots of the specimen
collected for validity screening and initial validity and drug testing
at the licensee testing facility, as permitted under Sec.
26.31(d)(3)(ii), or to test for additional drugs, as permitted under
Sec. 26.31(d)(1)(i)(A), but only if sufficient urine is available for
such testing after the specimen has been split into Bottle A and Bottle
B.
Sec. 26.115 Collecting a urine specimen under direct observation.
(a) Procedures for collecting urine specimens must provide for the
donor's privacy unless directed by this part or the MRO or FFD program
manager determines that a directly observed collection is warranted.
The following circumstances constitute the exclusive grounds for
performing a directly observed collection:
(1) The donor has presented, at this or a previous collection, a
urine specimen that the HHS-certified laboratory reported as being
substituted, adulterated, or invalid to the MRO and the MRO reported to
the licensee or other entity that there is no adequate medical
explanation for the result;
(2) The donor has presented, at this collection, a urine specimen
that falls outside the required temperature range, and
(i) Either the donor declines to provide a measurement of body
temperature; or
(ii) The donor's measured body temperature varies by more than 1EC/
1.8EF from the temperature of the specimen;
(3) The collector observes conduct clearly and unequivocally
indicating an attempt to dilute, substitute, or adulterate the
specimen; and
(4) A directly observed collection is required under Sec. 26.69.
(b) Before collecting a urine specimen under direct observation,
the collector shall obtain the agreement of the FFD program manager or
MRO to obtain a urine specimen under direct observation. After
obtaining agreement, the collector shall ensure that a specimen is
collected under direct observation as soon as reasonably practicable.
(c) The collector shall explain to the donor the reason for direct
observation of the collection under paragraph (a) of this section.
(d) The collector shall complete a new custody-and-control form for
the specimen that is obtained from the directly observed collection.
The collector shall record that the collection was observed and the
reason(s) for the directly observed collection on the form.
(e) The collector shall ensure that the observer is the same gender
as the individual. A person of the opposite gender may not act as the
observer under any conditions. The observer may be a different person
from the collector and need not be a qualified collector.
(f) If someone other than the collector is to observe the
collection, the collector shall verbally instruct the observer to
follow the procedures in this paragraph. The individual who observes
the collection shall follow these procedures:
(1) The observer shall instruct the donor to adjust his or her
clothing to ensure that the area of the donor's body between the waist
and knees is exposed;
(2) The observer shall watch the donor urinate into the collection
container. Specifically, the observer shall watch the urine go from the
donor's body into the collection container;
(3) If the observer is not the collector, the observer may not take
the collection
[[Page 50646]]
container from the donor, but shall observe the specimen as the donor
takes it to the collector; and
(4) If the observer is not the collector, the collector shall
record the observer's name on the custody-and-control form.
(g) If a donor declines to allow a directly observed collection
that is required or permitted under this section, this constitutes a
refusal to test.
(h) If a collector learns that a directly observed collection
should have been performed but was not, the collector shall inform the
FFD program manager, or his or her designee. The FFD program manager or
designee shall ensure that a directly observed collection is
immediately performed.
Sec. 26.117 Preparing urine specimens for storage and shipping.
(a) Both the donor and the collector shall keep the donor's urine
specimen(s) in view at all times before the specimen(s) are sealed and
labeled. If any specimen or aliquot is transferred to another
container, the collector shall ask the donor to observe the transfer
and sealing of the container with a tamper-evident seal.
(b) Both the collector and the donor shall be present (at the same
time) during the procedures outlined in this section.
(c) The collector shall place an identification label securely on
each container. The label must contain the date, the donor's specimen
number, and any other identifying information provided or required by
the FFD program. The collector shall also apply a tamper-evident seal
on each container if it is separate from the label. The specimen bottle
must be securely sealed to prevent undetected tampering.
(d) The donor shall initial the identification label(s) on the
specimen bottle(s) for the purpose of certifying that the specimen was
collected from him or her. The collector shall also ask the donor to
read and sign a statement on the custody-and-control form certifying
that the specimen(s) identified as having been collected from the donor
is, in fact, the specimen(s) that he or she provided.
(e) The collector shall complete the custody-and-control form(s)
and shall certify proper completion of the collection.
(f) The specimens and chain-of-custody forms must be packaged for
transfer to the HHS-certified laboratory or the licensee's testing
facility. If the specimens are not immediately prepared for transfer,
they must be appropriately safeguarded during temporary storage.
(g) While any part of the chain-of-custody procedures is being
performed, the specimens and custody documents must be under the
control of the involved collector. The collector may not leave the
collection site during the interval between presentation of the
specimen by the donor and securing of the specimens with identifying
labels bearing the donor's specimen identification numbers and seals
initialed by the donor. If the involved collector momentarily leaves
his or her workstation, the sealed specimens and custody-and-control
forms must be secured or taken with him or her. If the collector is
leaving for an extended period of time, the specimens must be packaged
for transfer to the HHS-certified laboratory or the licensee testing
facility and secured before the collector leaves the collection site.
(h) The specimen(s) sealed in a shipping container must be
immediately transferred, appropriately safeguarded during temporary
storage, or kept under the personal control of an authorized individual
until transferred. These minimum procedures apply to the transfer of
specimens to licensee testing facilities from collection sites (except
where co-located) as well as to the shipping of specimens to HHS-
certified laboratories. As an option, licensees and other entities may
ship several specimens via courier in a locked or sealed shipping
container.
(i) Collection site personnel shall ensure that a custody-and-
control form is packaged with its associated urine specimen bottle.
Unless a collection site and a licensee testing facility are co-
located, the sealed and labeled specimen bottles, with their associated
custody-and-control forms that are being transferred from the
collection site to the drug testing laboratory must be placed in a
second, tamper-evident shipping container. The second container must be
designed to minimize the possibility of damage to the specimen during
shipment (e.g., specimen boxes, shipping bags, padded mailers, or bulk
insulated shipping containers with that capability), so that the
contents of the shipping containers are no longer accessible without
breaking a tamper-evident seal.
(j) Collection site personnel shall arrange to transfer the
collected specimens to the HHS-certified laboratory or the licensee
testing facility. Licensees and other entities shall take appropriate
and prudent actions to minimize false negative results from specimen
degradation. Specimens that have not been shipped to the HHS-certified
laboratory or the licensee testing facility within 24 hours of
collection and any specimen that is suspected of having been
substituted, adulterated, or tampered with in any way must be
maintained cooled to not more than 6 [deg]C (42.8 [deg]F) until they
are shipped to the HHS-certified laboratory. Specimens must be shipped
from the collection site to the HHS-certified laboratory or the
licensee testing facility as soon as reasonably practical but, except
under unusual circumstances, the time between specimen shipment and
receipt of the specimen at the licensee testing facility or HHS-
certified laboratory should not exceed 2 business days.
(k) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, there is no requirement that such personnel
document chain of custody on the custody-and-control forms during
transit. Custody accountability of the shipping containers during
shipment must be maintained by a tracking system provided by the
courier, express carrier, or postal service.
Sec. 26.119 Determining ``shy'' bladder.
(a) When a donor has not provided a specimen of at least 30 mL
within the 3 hours permitted for urine collection, FFD program
personnel shall direct the donor to obtain, within 5 business days, an
evaluation from a licensed physician who is acceptable to the MRO and
has expertise in the medical issues raised by the donor's failure to
provide a sufficient specimen. The MRO may perform this evaluation if
the MRO has the appropriate expertise.
(b) If another physician will perform the evaluation, the MRO shall
provide the other physician with the following information and
instructions:
(1) The donor was required to take a drug test, but was unable to
provide a sufficient quantity of urine to complete the test;
(2) The potential consequences of refusing to take the required
drug test; and
(3) The physician must agree to follow the requirements of
paragraphs (c) through (f) of this section.
(c) The physician who conducts this evaluation shall make one of
the following determinations:
(1) A medical condition has, or with a high degree of probability
could have, precluded the donor from providing a sufficient amount of
urine; or
(2) There is an inadequate basis for determining that a medical
condition has, or with a high degree of probability could have,
precluded the donor from providing a sufficient quantity of urine.
[[Page 50647]]
(d) For purposes of this section, a medical condition includes an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a medically documented pre-existing psychological
disorder, but does not include unsupported assertions of ``situational
anxiety'' or dehydration.
(e) The physician who conducts this evaluation shall provide a
written statement of his or her determination and the basis for it to
the MRO. This statement may not include detailed information on the
donor's medical condition beyond what is necessary to explain the
determination.
(f) If the physician who conducts this evaluation determines that
the donor's medical condition is a serious and permanent or long-term
disability that is highly likely to prevent the donor from providing a
sufficient amount of urine for a very long or indefinite period of
time, the physician shall set forth this determination and the reasons
for it in the written statement to the MRO.
(g) The MRO shall seriously consider and assess the information
provided by the physician in deciding whether the donor has a medical
condition that has, or with a high degree of probability could have,
precluded the donor from providing a sufficient amount of urine, as
follows:
(1) If the MRO concurs with the physician's determination, then the
MRO shall declare that the donor has not violated the FFD policy and
the licensee or other entity shall take no further action with respect
to the donor;
(2) If the MRO determines that the medical condition has not, or
with a high degree of probability could not have, precluded the donor
from providing a sufficient amount of urine, then the MRO shall declare
that there has been a refusal to test; or
(3) If the MRO determines that the medical condition is highly
likely to prevent the donor from providing a sufficient amount of urine
for a very long or indefinite period of time, then the MRO shall
authorize an alternative evaluation process, tailored to the individual
case, for drug testing.
Subpart F--Licensee Testing Facilities
Sec. 26.121 Purpose.
This subpart contains requirements for facilities that are operated
by licensees and other entities who are subject to this part to perform
initial tests of urine specimens for validity, drugs, and drug
metabolites.
Sec. 26.123 Testing facility capabilities.
Each licensee testing facility shall have the capability, at the
same premises, to perform either validity screening tests or initial
validity tests or both, and initial drug tests for each drug and drug
metabolite for which testing is conducted.
Sec. 26.125 Licensee testing facility personnel.
(a) Each licensee testing facility shall have one or more
individuals who are responsible for day-to-day operations and
supervision of the testing technicians. The designated individual(s)
shall have at least a bachelor's degree in the chemical or biological
sciences, medical technology, or equivalent. He or she shall also have
training and experience in the theory and practice of the procedures
used in the licensee testing facility, and a thorough understanding of
quality control practices and procedures, the review, interpretation,
and reporting of test results, and proper remedial actions to be taken
in response to detection of abnormal test or quality control results.
(b) Other technicians or non-technical staff shall have the
necessary training and skills for their assigned tasks. Technicians who
perform urine specimen testing shall have documented proficiency in
operating the testing instruments and devices used at the licensee
testing facility.
(c) Licensee testing facility personnel files must include each
individual's resume of training and experience; certification or
license, if any; references; job descriptions; records of performance
evaluations and advancement; incident reports, if any; results of tests
that establish employee competency for the position he or she holds;
and appropriate data to support determinations of honesty and integrity
conducted in accordance with this part.
Sec. 26.127 Procedures.
(a) Licensee testing facilities shall develop, implement, and
maintain clear and well-documented procedures for accession, shipment,
and testing of urine specimens.
(b) Written chain-of-custody procedures must describe the methods
to be used to maintain control and accountability of specimens from
receipt through completion of testing and reporting of results, during
storage and shipping to the HHS-certified laboratory, and continuing
until final disposition of the specimens.
(c) Licensee testing facilities shall develop, implement, and
maintain written standard operating procedures for each assay performed
for drug and specimen validity testing. If a licensee testing facility
performs validity screening tests with non-instrumented devices, the
licensee testing facility shall develop, implement, and maintain
written standard operating procedures for each device. The procedures
must include, but are not limited to, detailed descriptions of--
(1) The principles of each test;
(2) Preparation of reagents, standards, and controls;
(3) Calibration procedures;
(4) Derivation of results;
(5) Linearity of the methods;
(6) Sensitivity of the methods;
(7) Cutoff values;
(8) Mechanisms for reporting results;
(9) Controls;
(10) Criteria for unacceptable specimens and results;
(11) Reagents and expiration dates; and
(12) References.
(d) Licensee testing facilities shall develop, implement, and
maintain written procedures for instrument and device setup and normal
operation, including the following:
(1) A schedule for checking critical operating characteristics for
all instruments and devices;
(2) Tolerance limits for acceptable function checks; and
(3) Instructions for major troubleshooting and repair.
(e) Licensee testing facilities shall develop, implement, and
maintain written procedures for remedial actions to be taken when
systems and non-instrumented testing devices (if used for validity
screening tests) are out of acceptable limits or errors are detected.
Each facility shall maintain documentation that these procedures are
followed and that all necessary corrective actions are taken. In
addition, each facility shall have systems in place to verify all
stages of testing and reporting and to document the verification.
Sec. 26.129 Assuring specimen security, chain of custody, and
preservation.
(a) Each licensee testing facility shall be secure at all times.
Each facility shall have in place sufficient security measures to
control access to the premises and to ensure that no unauthorized
personnel handle specimens or gain access to the licensee testing
facility's processes or areas where records are stored. Access to these
secured areas must be limited to specifically authorized individuals
whose authorization is documented. All authorized visitors and
maintenance and service personnel shall be escorted at all times while
in the licensee testing facility.
(b) When specimens are received, licensee testing facility
personnel shall
[[Page 50648]]
inspect each package for evidence of possible tampering and shall
compare information on specimen containers within each package to the
information on the accompanying custody-and-control forms. Licensee
testing facility personnel shall attempt to resolve any discrepancies
identified in the information on specimen bottles or on the
accompanying custody-and-control forms. Indications of tampering with
specimens in transit from the collection site, or at a licensee testing
facility, must be reported to senior licensee or other entity
management as soon as practical and no later than 8 hours after the
indications are identified. In response to such reports, licensee or
other entity management personnel shall initiate an investigation to
determine whether tampering has occurred. If the investigation
determines that tampering has occurred, licensee or other entity
management shall ensure that corrective actions are taken. If there is
reason to believe that the integrity or identity of a specimen is in
question (as a result of tampering or discrepancies between the
information on specimen bottle and on the accompanying custody-and-
control forms that cannot be resolved), the specimen may not be tested
and the licensee or other entity shall ensure that another collection
occurs as soon as reasonably practical.
(c) The licensee testing facility shall retain specimen containers
within the testing facility's accession area until all analyses have
been completed. Testing facility personnel shall use aliquots of the
specimen and licensee testing facility chain-of-custody forms, or other
appropriate methods of tracking aliquot custody and control, when
conducting validity screening and initial validity and drug tests. The
original specimen bottles and the original custody-and-control forms
must remain in secure storage. Licensee testing facility personnel may
discard specimens and aliquots as soon as practical after validity
screening or initial validity tests have demonstrated that the specimen
appears valid and initial test results for drugs and drug metabolites
are negative.
(d) The licensee testing facility's procedure for tracking custody
and control of specimens and aliquots must protect the identity of the
donor, and provide documentation of the testing process and transfers
of custody of the specimen and aliquots. Each time a specimen or
aliquot is handled or transferred within the licensee testing facility,
testing facility personnel shall document the date and purpose and
every individual in the chain of custody must be identified.
(e) Urine specimens identified as non-negative at a licensee
testing facility must be shipped to an HHS-certified laboratory for
testing as soon as reasonably practical.
(f) Licensee testing facility personnel shall take appropriate and
prudent actions to minimize false negative results from specimen
degradation. If validity screening, initial validity, or initial drug
test results are non-negative or if a specimen has not been tested
within 24 hours of receipt at the licensee testing facility, then the
facility shall maintain the specimen cooled to not more than 6 [deg]C
(42.8 [deg]F) until it is forwarded to the HHS-certified laboratory for
further testing, if required. Split specimens in Bottle B that are
associated with non-negative specimens in Bottle A must also be
maintained cooled (as previously specified) until test results from the
HHS-certified laboratory are known to be negative for Bottle A; until
the MRO informs the licensee testing facility that Bottle B must be
forwarded to an HHS-certified laboratory for testing; or until the
specimen is moved to long-term, frozen storage, in accordance with
Sec. 26.135(c).
(g) Licensee testing facility personnel shall ensure that the
original custody-and-control form is packaged with its associated urine
specimen bottle. Sealed and labeled specimen bottles, with their
associated custody-and-control forms, being transferred from the
licensee testing facility to the HHS-certified laboratory must be
placed in a second, tamper-evident shipping container designed to
minimize the possibility of damage to the specimen during shipment
(e.g., specimen boxes, padded mailers, or bulk insulated shipping
containers with that capability) so that the contents of the shipping
containers are no longer accessible without breaking a tamper-evident
seal.
(h) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, such personnel are not required to document chain
of custody on the custody-and-control forms during transit. Custody
accountability of the shipping containers during shipment must be
maintained by a tracking system provided by the courier, express
carrier, or postal service.
Sec. 26.131 Cutoff levels for validity screening and initial validity
tests.
(a) Each validity test result from the licensee testing facility
must be based on performing either a validity screening test or an
initial validity test, or both, on one or more aliquots of a urine
specimen. The licensee testing facility shall forward any specimen that
yields a non-negative validity screening or initial validity test
result to the HHS-certified laboratory for further testing. Licensee
testing facilities need not perform validity screening tests before
conducting initial validity tests of a specimen.
(b) At a minimum, the licensee testing facility shall test each
urine specimen for creatinine, pH, and one or more oxidizing
adulterants. Licensees and other entities may not specify more
stringent cutoff levels for validity screening and initial validity
tests than those specified in this section. If tests or observations
indicate one or more of the following from either a validity screening
test or an initial validity test, the licensee testing facility shall
forward the specimen to the HHS-certified laboratory for additional
testing:
(1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);
(2) Using either a colorimetric pH test or pH meter, the pH of the
specimen meets either of the following criteria:
(i) pH less than 3, or
(ii) pH equal to or greater than 9.
(3) Nitrite concentration is equal to or greater than 500
micrograms (mcg) per milliliter (mL) using either a nitrite
colorimetric test or a general oxidant colorimetric test;
(4) Presence of chromium (VI) is indicated using either a general
oxidant colorimetric test (with a cutoff equal to or greater than 50
mcg/mL chromium (VI) equivalents) or a chromium (VI) colorimetric test
(chromium (VI) concentration equal to or greater than 50 mcg/mL);
(5) Presence of halogen (e.g., bleach, iodine, fluoride) is
indicated using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite equivalents or equal
to or greater than 50 mcg/mL chromium (VI) equivalents) or a halogen
colorimetric test (halogen concentration equal to or greater than the
LOD);
(6) Presence of glutaraldehyde is indicated using either an
aldehyde test (aldehyde present) or the characteristic immunoassay
response is observed on one or more drug immunoassay tests;
(7) Presence of pyridine (pyridinium chlorochromate) is indicated
using either a general oxidant colorimetric test (with a cutoff equal
to or greater than 200 mcg/mL nitrite equivalents or equal to or
greater than 50 mcg/mL chromium (VI) equivalents) or a chromium (VI)
colorimetric test (chromium (VI) concentration equal to or greater than
50 mcg/mL);
(8) Presence of a surfactant is indicated by using a surfactant
colorimetric test with a cutoff equal to
[[Page 50649]]
or greater than 100 mcg/mL dodecylbenzene sulfonate equivalent; or
(9) The specimen shows evidence of adulterants, including, but not
limited to, the following:
(i) Abnormal physical characteristics;
(ii) Reactions or responses characteristic of an adulterant
obtained during the initial test; or
(iii) A possible unidentified interfering substance or adulterant,
demonstrated by interference occurring on the immunoassay drug tests on
separate aliquots (i.e., valid immunoassay drug test results cannot be
obtained).
Sec. 26.133 Cutoff levels for drugs and drug metabolites.
Subject to the provisions of Sec. 26.31(d)(3)(iii), licensees and
other entities may specify more stringent cutoff levels for drugs and
drug metabolites than those in the table below and, in such cases, may
report initial test results for only the more stringent cutoff levels.
Otherwise, the following cutoff levels must be used for initial testing
of urine specimens to determine whether they are negative for the
indicated drugs and drug metabolites:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drug or metabolites (ng/mL)
------------------------------------------------------------------------
(a) Marijuana metabolites................................ 50
(b) Cocaine metabolites................................... 300
(c) Opiate metabolites.................................... 2,000
(d) Phencyclidine......................................... 25
(e) Amphetamines.......................................... 1,000
------------------------------------------------------------------------
Sec. 26.135 Split specimens.
(a) If the FFD program follows split-specimen procedures, as
described in Sec. 26.113, the licensee testing facility shall analyze
aliquots of the specimen for the licensee's or other entity's purposes
as described in this part. Except as provided in paragraph (b) in this
section, the licensee testing facility shall store Bottles A and B of
the specimen in a secure manner until the facility has finished
testing. If the initial validity and drug test results are negative and
the specimen in Bottle A will not be forwarded to the HHS-certified
laboratory, the licensee testing facility may discard both Bottle A and
B. If any test results are non-negative, the licensee testing facility
shall forward Bottle A to the HHS-certified laboratory for testing and
shall retain Bottle B in secure storage or may forward it to the HHS-
certified laboratory for storage.
(b) Within 3 business days (Monday through Friday, excluding
holidays) of being notified by the MRO that the HHS-laboratory reported
that donor's specimen yielded a non-negative test result, the donor may
request that the split specimen in Bottle B be tested by another HHS-
certified laboratory. The MRO shall inform the donor of this option,
and the specimen in Bottle B may be tested only at the request of
donor. When requested, the licensee or other entity shall ensure that
Bottle B is forwarded to an HHS-certified laboratory other than the
laboratory that tested the specimen in Bottle A as soon as practical,
and not later than one business day following the day of the donor's
request to have Bottle B tested. The donor shall provide his or her
written permission for the testing of Bottle B and neither the
licensee, MRO, NRC, nor any other entity may order testing of Bottle B
without the donor's written permission.
(c) If the MRO confirms that the specimen in Bottle A is non-
negative and the donor does not request that Bottle B be tested, the
licensee or other entity shall ensure that Bottle B is maintained in
long-term, frozen storage (-20 [deg]C or less) for a minimum of 1 year.
After the end of 1 year, the licensee or other entity may discard
Bottle B, with the exception that the licensee testing facility shall
retain any specimens under legal challenge, or as requested by the NRC,
until the specimen is no longer needed.
Sec. 26.137 Quality assurance and quality control.
(a) Quality assurance program. Each licensee testing facility shall
have a quality assurance program that encompasses all aspects of the
testing process including, but not limited to, specimen acquisition,
chain of custody, security, reporting of results, validity screening
(if validity screening tests are performed), initial validity and drug
testing, and validation of analytical procedures. Quality assurance
procedures must be designed, implemented, and reviewed to monitor the
conduct of each step of the process of validity testing and testing for
drugs and drug metabolites.
(b) Performance testing and quality control requirements for
validity screening tests. (1) Licensee testing facilities may rely upon
non-instrumented devices to perform validity screening tests to
determine the need for initial tests of specimen validity. Licensee
testing facilities shall use only non-instrumented devices to perform
validity screening tests that meet the following criteria:
(i) Either the device has been cleared by the U.S. Food and Drug
Administration and placed upon the SAMHSA list of point-of-collection
testing devices that are certified for use in the Federal Workplace
Drug Testing Program in the Federal Register; or
(ii) Before using the device, the licensee or other entity has
ensured that the device effectively determines the validity of a
specimen, as demonstrated by documentation that the device meets the
following performance testing requirements:
(A) A total of 100 devices in representative numbers from all
currently available manufactured lots of the device have been
performance tested by the licensee testing facility or an HHS-certified
laboratory following the manufacturer-specified testing procedures;
(B) The performance testing samples used to test the 100 devices
included samples with a nitrite concentration in the ranges of 650 mcg/
mL-800 mcg/mL or 250 mcg/mL-400 mcg/mL; a creatinine concentration in
the ranges of 5 mg/dL-20 mg/dL or 1 mg/dL-5 mg/dL; and pH in the ranges
of 1-3 or 10-12; and
(C) Test results from the performance testing required in this
paragraph show that the device correctly identified at least 80 percent
of the total validity test challenges or correctly identified at least
80 percent of the challenges for a specific validity test, and did not
report any sample as adulterated with a compound that was not present
in the sample.
(iii) After the licensee testing facility has placed the device in
service, the licensee or other entity shall verify either that the
device remains on the SAMHSA-certified list, or that the device
continues to effectively determine the validity of a specimen by
conducting, or requesting the HHS-certified laboratory to conduct
performance testing of 50 of the devices in representative numbers from
all currently available manufactured lots of the device in accordance
with the criteria specified in paragraphs (b)(1)(ii)(A) through
(b)(1)(ii)(C) of this section. This performance testing must be
performed at a nominal annual frequency.
(iv) In addition, the licensee or other entity shall ensure that
the manufacturer informs the licensee or other entity of any design
changes or alterations made to the device. If so informed, the licensee
or other entity shall consult with the MRO or the HHS-certified
laboratory to determine whether additional performance testing is
required to ensure that the modified device continues to be effective.
If the MRO or HHS-certified laboratory
[[Page 50650]]
recommends additional performance testing, the licensee or other entity
shall ensure that it is completed in accordance with paragraph
(b)(1)(iii) of this section.
(2) At the beginning of any 8-hour period during which the licensee
testing facility will perform validity screening tests, licensee
testing facility personnel shall test a minimum of 1 quality control
sample that is negative for each specific validity test to be performed
(e.g., nitrites, chromium) during the 8-hour period, and 1 quality
control sample that is non-negative for the specific validity test to
be performed during the 8-hour period. The results of these tests must
be correct before any donor specimens may be tested. If correct results
are not obtained (i.e., the device provided either false positive or
false negative results), the licensee testing facility shall
immediately stop using the device and conduct the investigation
required in paragraph (f) of this section. If the incorrect result is a
false negative result, licensees and other entities shall notify the
NRC in accordance with Sec. 26.219(c)(3).
(3) The licensee testing facility shall also submit at least 1
specimen out of every 10 specimens that test negative using the non-
instrumented validity screening device to an HHS-certified laboratory
as part of the licensee testing facility's quality assurance program.
If results from the HHS-certified laboratory indicate that a device
failed to perform correctly (i.e., provided either false positive or
false negative results), the licensee or other entity shall immediately
stop using the device and conduct the investigation required in
paragraph (f) of this section. If the incorrect result is a false
negative result, licensees and other entities shall notify the NRC in
accordance with Sec. 26.219(c)(3).
(4) Validity screening tests must measure a specimen's creatinine
concentration to 1 decimal place.
(5) Dipsticks, colorimetric pH tests that have a narrow dynamic
range and do not support the 2-12 pH cutoffs, and pH paper may be used
only for validity screening tests to determine whether initial validity
tests must be performed. The pH screening tests must have, at a
minimum, the following controls:
(i) One control below the lower decision point in use;
(ii) One control between the decision points in use; and
(iii) One control above the upper decision point in use.
(6) Licensee testing facilities may use either a general oxidizing
adulterant test or one or more specific oxidizing adulterant tests for
validity screening tests. When a general oxidizing adulterant test is
used, the test must be able to detect at least the activity equivalent
of 500 mcg/mL of nitrite. Dipsticks that meet the performance testing
requirements in paragraph (b)(1) through (b)(3) of this section may be
used to determine the presence of nitrite or other oxidizing
adulterants at a concentration sufficient to require initial validity
testing.
(c) Non-negative validity screening test results. If the results of
a validity screening test indicate that the specimen may be
adulterated, substituted, dilute, or invalid, the licensee testing
facility may either perform initial validity testing or shall forward
the specimen to the HHS-certified laboratory for further testing.
(d) Quality control requirements for performing initial validity
tests.
(1) Creatinine. Creatinine concentration must be measured to 1
decimal place. The initial creatinine test must have a control in the
range of 3-20 mg/dL and a control in the range of 21-25 mg/dL.
(2) Requirements for performing initial pH tests are as follows:
(i) Colorimetric pH tests that have a dynamic range of 2-12 and pH
meters must be capable of measuring pH to 1 decimal place.
(ii) An initial colorimetric pH test must have the following
calibrators and controls:
(A) One calibrator at 3;
(B) One calibrator at 11;
(C) One control in the range of 2-2.8;
(D) One control in the range of 3.2-4;
(E) One control in the range of 4.5-9;
(F) One control in the range of 10-10.8; and
(G) One control in the range of 11.2-12.
(iii) If a pH screening test is not used, an initial pH meter test
must have the following calibrators and controls:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One calibrator at 10;
(D) One control in the range of 2-2.8;
(E) One control in the range of 3.2-4;
(F) One control in the range of 10-10.8; and
(G) One control in the range of 11.2-12.
(iv) If a pH screening test is used, an initial pH meter test must
have the following calibrators and controls when the screening result
indicates that the pH is below the lower decision point in use:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One control in the range of 2-2.8; and
(D) One control in the range of 3.2-4.
(v) If a pH screening test is used, an initial pH meter test must
have the following calibrators and controls when the screening test
result indicates that the pH is above the upper decision point in use:
(A) One calibrator at 7;
(B) One calibrator at 10;
(C) One control in the range of 10-10.8; and
(D) One control in the range of 11.2-12.
(3) Oxidizing adulterants. Initial tests for oxidizing adulterants
must include a calibrator at the appropriate cutoff concentration for
the compound of interest, a control without the compound of interest
(i.e., a certified negative control), and a control with at least one
of the compounds of interest at a measurable concentration. For
nitrite, the licensee testing facility shall have one control in the
range of 200-400 mcg/mL, one control in the range of 500-625 mcg/mL,
and a control without nitrite (i.e., a certified negative control).
(4) Other adulterants. Initial tests for other adulterants must
include an appropriate calibrator, a control without the compound of
interest (i.e., a certified negative control), and a control with the
compound of interest at a measurable concentration.
(e) Quality control requirements for initial drug tests. (1) Any
initial drug test performed by a licensee testing facility must use an
immunoassay that meets the requirements of the Food and Drug
Administration for commercial distribution. Licensee testing facilities
may not use non-instrumented immunoassay testing devices that are
pending HHS/SAMHSA review and approval for initial drug testing under
this part. In addition, licensees and other entities may not take
management actions on the basis of any drug test results obtained from
non-instrumented devices that may be used for validity screening tests.
(2) Licensee testing facilities shall discard negative specimens or
may pool them for use in the licensee testing facility's internal
quality control program after certification by an HHS-certified
laboratory that the specimens are negative and valid.
(3) Licensee testing facilities may perform multiple initial drug
tests for the same drug or drug class, provided that all tests meet the
cutoffs and quality control requirements of this part.
(4) Licensee testing facilities need not assess their false
positive testing rates for drugs, because all specimens that test as
positive on the initial tests for drugs and drug metabolites must be
[[Page 50651]]
forwarded to an HHS-certified laboratory for initial and confirmatory
testing.
(5) To ensure that the rate of false negative drug tests is kept to
the minimum that the immunoassay technology supports, licensee testing
facilities shall submit a minimum of 5 percent (or at least 1) of the
specimens screened as negative from every analytical run to the HHS-
certified laboratory.
(6) Quality control samples for each analytical run of specimens to
be initially tested for drugs by the licensee testing facility must
include--
(i) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(ii) At least one control fortified with a drug or drug metabolite
targeted at 25 percent above the cutoff;
(iii) At least one control fortified with a drug or drug metabolite
targeted at 75 percent of the cutoff.
(7) A minimum of 10 percent of all specimens in each analytical run
must be quality control samples, as defined in paragraph (e)(6) of this
section, that the licensee testing facility shall use for internal
quality control purposes. One percent of each run or at least 1 sample
(whichever is greater), must be blind performance test samples that
appear as normal samples to the licensee testing facility technicians.
Quality control samples are not forwarded to the HHS-certified
laboratory for testing.
(8) Licensee testing facilities shall document the implementation
of procedures to ensure that carryover does not contaminate the testing
of a donor's specimen.
(f) Errors in testing. Each licensee testing facility shall
investigate any testing errors or unsatisfactory performance discovered
in the testing of quality control samples, in the testing of actual
specimens, or through the processing of management reviews and/or MRO
reviews, as well as any other errors or matters that could adversely
reflect on the licensee testing facility's testing process. Whenever
possible, the investigation must determine relevant facts and identify
the root cause(s) of the testing or process error. The licensee testing
facility shall take action to correct the cause(s) of any errors or
unsatisfactory performance that are within the licensee testing
facility's control. A record of the investigative findings and the
corrective actions taken, where applicable, must be dated and signed by
the individuals who are responsible for the day-to-day management of
the licensee testing facility and reported to appropriate levels of
management.
(g) Accuracy. Volumetric pipettes and measuring devices must be
certified for accuracy or be checked by gravimetric, colorimetric, or
other verification procedure. Automatic pipettes and dilutors must be
checked for accuracy and reproducibility before being placed in
service, and periodically thereafter.
(h) Calibrators and controls. Calibrators and controls must be
prepared using pure drug reference materials, stock standard solutions
obtained from other laboratories, or standard solutions that are
obtained from commercial manufacturers and are properly labeled as to
content and concentration. Calibrators and controls may not be prepared
from the same stock solution. The standards and controls must be
labeled with the following dates: when received; when prepared or
opened; when placed in service; and when scheduled for expiration.
Sec. 26.139 Reporting initial validity and drug test results.
(a) The licensee testing facility shall report as negative all
specimens that appear to be valid on the basis of validity screening or
initial validity tests, or both, and are negative on the initial tests
for drugs and drug metabolites. Except as provided in this part, non-
negative test results from validity screening and initial validity and
drug tests at the licensee testing facility may not be reported to
licensee or other entity management.
(b) Except as provided in Sec. Sec. 26.37 and 26.75(h), access to
the results of initial tests must be limited to the licensee testing
facility's staff, the MRO and MRO staff, the FFD program manager, and,
when appropriate, EAP staff.
(c) The licensee testing facility shall provide qualified
personnel, when required, to testify in an administrative or
disciplinary proceeding against an individual when that proceeding is
based on urinalysis results reported by the licensee testing facility.
(d) The licensee testing facility shall prepare the information
required for the annual report to the NRC, as required in Sec. 26.217.
(e) The data in the annual report to the NRC must be presented for
either the cutoff levels specified in this part, or for more stringent
cutoff levels, if the FFD program uses more stringent cutoff levels for
drugs and drug metabolites. If the FFD program tests for drugs and drug
metabolites that are not specified in Sec. 26.31(d)(1), the summary
must also include the number of positive test results and the cutoff
levels used for those drugs and drug metabolites.
(f) The designated FFD program official shall use the available
information from the licensee testing facility's validity and drug test
results, the results of quality control testing performed at the
licensee testing facility, and the results from testing the quality
control samples that the licensee testing facility submits to the HHS-
certified laboratory to evaluate continued testing program
effectiveness and detect any local trends in drugs of abuse that may
require management action or FFD program adjustments. FFD program
adjustments may include, but are not limited to, training enhancements,
procedure changes, the expansion of the FFD program's drug panel to
include additional drugs to be tested, or changes in the types of
validity and drug testing devices, assays, or instruments used.
Subpart G--Laboratories Certified by the Department of Health and
Human Services
Sec. 26.151 Purpose.
This subpart contains requirements for the HHS-certified
laboratories that licensees and other entities who are subject to this
part use for testing urine specimens for validity and the presence of
drugs and drug metabolites.
Sec. 26.153 Using certified laboratories for testing urine specimens.
(a) Licensees and other entities who are subject to this part shall
use only HHS-certified laboratories for specimen validity and drug
testing, except as permitted under Sec. 26.31(d)(3)(ii).
(b) HHS-certified laboratories shall have the capability, at the
same premises, to perform both initial and confirmatory tests for
specimen validity and for each drug and drug metabolite for which the
HHS-laboratory provides services to the licensee or other entity.
(c) An HHS-certified laboratory may not subcontract and shall
perform all work with its own personnel and equipment unless otherwise
authorized by the licensee or other entity.
(d) Licensees and other entities shall use only HHS-certified
laboratories that agree to follow the same rigorous specimen testing,
quality control, and chain-of-custody procedures when testing for more
stringent cutoff levels as may be specified by licensees and other
entities for the classes of drugs identified in this part, and for any
other substances included in the licensees' or other entities' panels.
(e) Before awarding a contract to an HHS-certified laboratory, the
licensee or other entity shall ensure that qualified personnel conduct
a pre-award
[[Page 50652]]
inspection and evaluation of the procedural aspects of the laboratory's
drug testing operations. However, if an HHS-certified laboratory loses
its certification, in whole or in part, a licensee or other entity may
immediately begin using another HHS-certified laboratory that is being
used by another licensee or entity who is subject to this part, in
accordance with the requirements of Sec. 26.41(g)(5).
(f) All contracts between licensees or other entities who are
subject to this part and HHS-certified laboratories must require the
laboratory to implement all applicable requirements of this part. At a
minimum, licensees' and other entities' contracts with HHS-certified
laboratories must include the following requirements:
(1) Laboratory facilities shall comply with the applicable
provisions of any State licensor requirements;
(2) The laboratory shall make available qualified personnel to
testify in an administrative or disciplinary proceeding against an
individual when that proceeding is based on urinalysis results reported
by the HHS-certified laboratory;
(3) The laboratory shall maintain test records in confidence,
consistent with the requirements of Sec. 26.39, and use them with the
highest regard for individual privacy;
(4) Consistent with the principles established in Section 503 of
Public Law 100-71, any employee of a licensee or other entity who is
the subject of a drug test shall, upon written request, have access to
the laboratory's records related to his or her validity and drug test
and any records related to the results of any relevant certification,
review, or revocation-of-certification proceedings;
(5) The laboratory may not enter into any relationship with the
licensee's or other entity's MRO(s) that may be construed as a
potential conflict of interest, and may not derive any financial
benefit by having a licensee or other entity use a specific MRO; and
(6) The laboratory shall permit representatives of the NRC and any
licensee or other entity using the laboratory's services to inspect the
laboratory at any time, including unannounced inspections.
(g) If licensees or other entities use a form other than the
current Federal custody-and-control form, licensees and other entities
shall provide a memorandum to the laboratory explaining why a non-
Federal form was used, but must ensure, at a minimum, that the form
used contains all the required information on the Federal custody-and-
control form.
Sec. 26.155 Laboratory personnel.
(a) Day-to-day management of the HHS-certified laboratory. HHS-
certified laboratories shall have a responsible person to assume
professional, organizational, educational, and administrative
responsibility for the laboratory's drug testing facilities.
(1) This individual shall have documented scientific qualifications
in analytical forensic toxicology. Minimum qualifications are as
follows:
(i) Certification by the appropriate State as a laboratory director
in forensic or clinical laboratory toxicology; or
(ii) A PhD in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or
(iii) Training and experience comparable to a PhD in one of the
natural sciences, such as a medical or scientific degree with
additional training and laboratory/research experience in biology,
chemistry, and pharmacology or toxicology; and
(iv) In addition to the requirements in paragraphs (a)(1)(i)
through (a)(1)(iii) of this section, the responsible person shall also
have the following minimum qualifications:
(A) Appropriate experience in analytical forensic toxicology
including experience with the analysis of biological material for drugs
of abuse; and
(B) Appropriate training and/or experience in forensic applications
of analytical toxicology, e.g., publications, court testimony, research
concerning analytical toxicology of drugs of abuse, or other factors
that qualify the individual as an expert witness in forensic
toxicology.
(2) This individual shall be engaged in and responsible for the
day-to-day management of the testing laboratory, even if another
individual has overall responsibility for an entire multi-specialty
laboratory.
(3) This individual shall be responsible for ensuring that there
are enough personnel with adequate training and experience to supervise
and conduct the work of the drug testing laboratory. He or she shall
ensure the continued competency of laboratory personnel by documenting
their in-service training, reviewing their work performance, and
verifying their skills.
(4) This individual shall be responsible for ensuring that the
laboratory has procedures that are complete, up-to-date, available for
personnel performing tests, and followed by those personnel. The
procedures must be reviewed, signed, and dated by this responsible
person whenever the procedures are first placed into use or changed or
when a new individual assumes responsibility for management of the
laboratory. This individual shall ensure that copies of all procedures
and records of the dates on which they are in effect are maintained.
(Specific contents of the procedures are described in Sec. 26.157.)
(5) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; maintaining acceptable analytical performance for all
controls and standards; maintaining quality control testing; and
assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test
system.
(6) This individual shall be responsible for taking all remedial
actions that may be necessary to maintain satisfactory operation and
performance of the laboratory in response to quality control systems
not being within performance specifications, including errors in result
reporting or in the analysis of performance testing results. This
individual shall ensure that test results are not reported until all
corrective actions have been taken and he or she can assure that the
test results provided are accurate and reliable.
(b) Certifying scientist. (1) HHS-certified laboratories shall have
one or more certifying scientists who review all pertinent data and
quality control results to attest to the validity of the laboratory's
test results.
(2) A certifying scientist shall be an individual with at least a
bachelor's degree in the chemical or biological sciences, medical
technology, or an equivalent field who reviews all pertinent data and
quality control results. The individual shall have training and
experience in the theory and practice of all methods and procedures
used in the laboratory, including a thorough understanding of chain-of-
custody procedures, quality control practices, and analytical
procedures relevant to the results that the individual certifies.
Relevant training and experience must also include the review,
interpretation, and reporting of tests results; maintenance of chain of
custody; and proper remedial action to be taken in response to aberrant
test or quality control results, or a determination that test systems
are out of control limits.
(3) A laboratory may designate certifying scientists who only
certify results that are reported negative and certifying scientists
who certify results
[[Page 50653]]
that are reported both negative and non-negative.
(c) Day-to-day operations and supervision of analysts. HHS-
certified laboratories shall assign one or more individuals who are
responsible for day-to-day operations and supervision of the technical
analysts. The designated individual(s) shall have at least a bachelor's
degree in the chemical or biological sciences, medical technology, or
an equivalent field. The individual(s) shall also have training and
experience in the theory and practice of the procedures used in the
laboratory, resulting in his or her thorough understanding of quality
control practices and procedures; review, interpretation, and reporting
of test results; maintenance of chain-of-custody; and proper remedial
actions to be taken in response to aberrant test or quality control
results, or the finding that test systems are out of control limits.
(d) Other personnel. Other technicians or nontechnical staff shall
have the necessary training and skills for their assigned tasks.
(e) Training. HHS-certified laboratories shall make available
continuing education programs to meet the needs of laboratory
personnel.
(f) Files. At a minimum, each laboratory personnel file must
include a resume, any professional certification(s) or license(s), a
job description, and documentation to show that the individual has been
properly trained to perform his or her job.
Sec. 26.157 Procedures.
(a) HHS-certified laboratories shall develop, implement, and
maintain clear and well-documented procedures for accession, receipt,
shipment, and testing of urine specimens.
(b) Written chain-of-custody procedures must describe the methods
to be used to maintain control and accountability of specimens from
receipt through completion of testing, reporting of results, during
storage and shipping to another HHS-certified laboratory, if required,
and continuing until final disposition of specimens.
(c) HHS-certified laboratories shall develop, implement, and
maintain written standard operating procedures for each assay performed
for licensees and other entities for drug and specimen validity
testing. The procedures must include, but are not limited to, detailed
descriptions of--
(1) The principles of each test;
(2) Preparation of reagents, standards, and controls;
(3) Calibration procedures;
(4) Derivation of results;
(5) Linearity of methods;
(6) Sensitivity of the methods;
(7) Cutoff values;
(8) Mechanisms for reporting results;
(9) Controls;
(10) Criteria for unacceptable specimens and results;
(11) Reagents and expiration dates; and
(12) References.
(d) HHS-certified laboratories shall develop, implement, and
maintain written procedures for instrument setup and normal operation,
including the following:
(1) A schedule for checking critical operating characteristics for
all instruments;
(2) Tolerance limits for acceptable function checks; and
(3) Instructions for major troubleshooting and repair.
(e) HHS-certified laboratories shall develop, implement, and
maintain written procedures for remedial actions to be taken when
errors are detected or systems are out of acceptable limits. The
laboratory shall maintain documentation that its personnel follow these
procedures and take all necessary corrective actions. In addition, the
laboratory shall have systems in place to verify all stages of testing
and reporting and to document the verification.
Sec. 26.159 Assuring specimen security, chain of custody, and
preservation.
(a) The HHS-certified laboratories performing services for
licensees and other entities under this part shall be secure at all
times. Each laboratory shall have in place sufficient security measures
to control access to the premises and to ensure that no unauthorized
personnel handle specimens or gain access to the laboratory processes
or areas where records are stored. Access to these secured areas must
be limited to specially authorized individuals whose authorization is
documented. All authorized visitors, and maintenance and service
personnel, shall be escorted at all times in the laboratory, except
personnel who are authorized to conduct inspections and audits on
behalf of licensees, other entities, the NRC, or the Secretary of the
Department of Health and Human Services, and emergency personnel
(including but not limited to firefighters and medical rescue teams).
(b) When a shipment of specimens is received, laboratory personnel
shall inspect each package for evidence of possible tampering and shall
compare information on specimen bottles within each package to the
information on the accompanying custody-and-control forms. Any direct
evidence of tampering or discrepancies in the information on the
specimen bottles and the custody-and-control forms attached to the
shipment must be reported to the licensee or other entity within 24
hours of the discovery and must be noted on the custody-and-control
forms for each specimen contained in the package. Upon notification,
the licensee or other entity shall ensure that an investigation is
initiated to determine whether tampering has occurred. If the
investigation determines that tampering has occurred, the licensee or
other entity shall ensure that corrective actions are taken. If the
licensee or other entity has reason to question the integrity and
identity of the specimens, the specimens may not be tested and the
licensee or other entity shall ensure that another collection occurs as
soon as reasonably practical.
(c) The HHS-certified laboratory shall retain specimen bottles
within the laboratory's accession area until all analyses have been
completed. Laboratory personnel shall use aliquots and laboratory
internal custody-and-control forms when conducting initial and
confirmatory tests. The original specimen and the original custody-and-
control form must remain in secure storage.
(d) The laboratory's internal custody-and-control form must allow
for identification of the donor, and documentation of the testing
process and transfers of custody of the specimen.
(e) Each time a specimen is handled or transferred within the
laboratory, laboratory personnel shall document the date and purpose on
the custody-and-control form and every individual in the chain shall be
identified. Authorized technicians are responsible for each urine
specimen or aliquot in their possession and shall sign and complete
custody-and-control forms for those specimens or aliquots as they are
received.
(f) If a specimen is to be transferred to a second HHS-certified
laboratory, laboratory personnel shall ensure that the original
custody-and-control form is packaged with its associated urine specimen
bottle. Sealed and labeled specimen bottles, with their associated
custody-and-control forms, being transferred from one laboratory to
another must be placed in a second, tamper-evident shipping container
designed to minimize the possibility of damage to the specimen during
shipment (e.g., specimen boxes, padded mailers, or bulk insulated
shipping containers with that capability) so that the contents of the
shipping containers
[[Page 50654]]
are inaccessible without breaking a tamper-evident seal.
(g) Couriers, express carriers, and postal service personnel do not
have direct access to the custody-and-control forms or the specimen
bottles. Therefore, such personnel are not required to document chain
of custody on the custody-and-control forms during transit. Custody
accountability of the shipping containers during shipment must be
maintained by a tracking system provided the courier, express carrier,
or postal service.
(h) Specimens that do not receive an initial test within 7 days of
arrival at the laboratory must be placed in secure refrigeration units
for short-term storage. Temperatures may not exceed 6 [deg]C. The
laboratory shall ensure proper storage conditions in the event of a
prolonged power failure.
(i) Long-term frozen storage at a temperature of -20 [deg]C or less
ensures that drug-positive, adulterated, substituted, and invalid urine
specimens and Bottle B of a split specimen will be available for any
necessary retests. Unless otherwise authorized in writing by the
licensee or other entity, laboratories shall retain and place in
properly secured long-term frozen storage all specimens reported as
drug positive, adulterated, substituted, or invalid. At a minimum, such
specimens must be stored for 1 year. Within this 1-year period, a
licensee, other entity, or the NRC may ask the laboratory to retain the
specimen for an additional period of time. If no retention request is
received, the laboratory may discard the specimen after the end of 1
year. However, the laboratory shall retain any specimens under review
or legal challenge until they are no longer needed.
(j) The laboratory shall discard a valid specimen that tests
negative on initial or confirmatory drug tests or may pool such
specimens for use in the laboratory's internal quality control program
after certifying that the specimens are negative and valid.
Sec. 26.161 Cutoff levels for validity testing.
(a) Validity test results. Each validity test result must be based
on performing an initial validity test on one aliquot and a
confirmatory validity test on a second aliquot.
(b) Initial validity testing. (1) The HHS-certified laboratory
shall test each specimen as follows:
(i) Determine the creatinine concentration;
(ii) Determine the specific gravity of every specimen for which the
creatinine concentration is less than 20 mg/dL;
(iii) Determine the pH;
(iv) Perform one or more initial validity tests for oxidizing
adulterants; and
(v) Perform additional validity tests, the choice of which depends
upon the observed indicators or characteristics below, when the
following conditions are observed:
(A) Abnormal physical characteristics;
(B) Reactions or responses characteristic of an adulterant obtained
during initial or confirmatory drug tests (e.g., non-recovery of
internal standards, unusual response); or
(C) Possible unidentified interfering substance or adulterant.
(2) If tests or observations indicate one or more of the following,
there is reason to believe the donor may have diluted, substituted, or
adulterated the specimen, and the laboratory shall subject the specimen
to confirmatory validity testing:
(i) Creatinine is less than 20 mg/dL;
(ii) Using either a colorimetric pH test or pH meter, the pH of the
specimen is found to meet any one of the following criteria:
(A) pH less than 3,
(B) pH equal to or greater than 11,
(C) pH equal to or greater than 3 and less than 4.5, or
(D) pH equal to or greater than 9 and less than 11;
(iii) The nitrite concentration is equal to or greater than 500
mcg/mL using either a nitrite colorimetric test or a general oxidant
colorimetric test;
(iv) The presence of chromium (VI) is indicated using either a
general oxidant colorimetric test (with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) equivalents ) or a chromium (VI)
colorimetric test (chromium (VI) with a cutoff concentration equal to
or greater than 50 mcg/mL);
(v) The presence of halogen (e.g., bleach, iodine, fluoride) is
indicated using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite equivalents or equal
to or greater than 50 mcg/mL chromium (VI) equivalents) or a halogen
colorimetric test (halogen cutoff concentration equal to or greater
than the LOD);
(vi) The presence of glutaraldehyde is indicated using either an
aldehyde test (aldehyde present) or the characteristic immunoassay
response is observed on one or more drug immunoassay tests;
(vii) The presence of pyridine (pyridinium chlorochromate) is
indicated using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite equivalents or equal
to or greater than 50 mcg/mL chromium (VI) equivalents) or a chromium
(VI) colorimetric test (chromium (VI) concentration equal to or greater
than 50 mcg/mL);
(viii) The presence of a surfactant is indicated by using a
surfactant colorimetric test with a cutoff equal to or greater than 100
mcg/mL dodecylbenzene sulfonate equivalent; or
(ix) The specimen provides evidence of adulterants, including, but
not limited to the following:
(A) Abnormal physical characteristics,
(B) Reactions or responses characteristic of an adulterant obtained
during the initial test, or
(C) Possible unidentified interfering substance or adulterant,
demonstrated by interference occurring on the immunoassay drug tests on
two separate aliquots (i.e., valid immunoassay drug test results cannot
be obtained).
(c) Results indicating an adulterated specimen. The laboratory
shall report a specimen as adulterated when the specimen yields any one
or more of the following validity testing results:
(1) The pH is less than 3, or equal to or greater than 11, using
either a pH meter or a colorimetric pH test for the initial test on the
first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(2) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant
colorimetric test for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion chromatography, capillary electrophoresis) on the second aliquot;
(3) The presence of chromium (VI) is verified using either a
general oxidant colorimetric test (with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) equivalents ) or a chromium (VI)
colorimetric test (chromium (VI) concentration equal to or greater than
50 mcg/mL) for the initial test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, atomic absorption spectrophotometry, capillary
electrophoresis, inductively coupled plasma-mass spectrometry) with the
chromium (VI) concentration equal to or greater than the LOD of the
confirmatory test on the second aliquot;
(4) The presence of halogen (e.g., bleach, iodine, fluoride) is
verified using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite equivalents or a
cutoff equal to or greater than 50 mcg/mL chromium (VI) equivalents) or
a halogen colorimetric test (halogen concentration equal to or greater
than the LOD) for the initial test on the first aliquot and a different
[[Page 50655]]
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, inductively coupled plasma-mass spectrometry) with a
specific halogen concentration equal to or greater than the LOD of the
confirmatory test on the second aliquot;
(5) The presence of glutaraldehyde is verified using either an
aldehyde test (aldehyde present) or the specimen yields the
characteristic immunoassay response on one or more drug immunoassay
tests for the initial test on the first aliquot and GC/MS for the
confirmatory test with the glutaraldehyde concentration equal to or
greater than the LOD of the analysis on the second aliquot;
(6) The presence of pyridine (pyridinium chlorochromate) is
verified using either a general oxidant colorimetric test (with a
cutoff equal to or greater than 200 mcg/mL nitrite equivalents or a
cutoff equal to or greater than 50 mcg/mL chromium (VI) equivalents) or
a chromium (VI) colorimetric test (chromium (VI) concentration equal to
or greater than 50 mcg/mL) for the initial test on the first aliquot
and GC/MS for the confirmatory test with the pyridine concentration
equal to or greater than the LOD of the analysis on the second aliquot;
(7) The presence of a surfactant is verified by using a surfactant
colorimetric test with a cutoff equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate equivalent for the initial test on the first
aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with a cutoff equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate equivalent on the second aliquot; or
(8) The presence of any other adulterant not specified in
paragraphs (c)(3) through (c)(7) of this section is verified using an
initial test on the first aliquot and a different confirmatory test on
the second aliquot.
(d) Results indicating a substituted specimen. The laboratory shall
report a specimen as substituted when the specimen's creatinine
concentration is less than 2 mg/dL and its specific gravity is less
than or equal to 1.0010, or equal to or greater than 1.0200, on both
the initial and confirmatory creatinine tests (i.e., the same
colorimetric test may be used to test both aliquots) and on both the
initial and confirmatory specific gravity tests (i.e., a refractometer
is used to test both aliquots) on two separate aliquots.
(e) Results indicating a dilute specimen. The laboratory shall
report a specimen as dilute when the specimen's creatinine
concentration is equal to or greater than 2 mg/dL but less than 20 mg/
dL and its specific gravity is greater than 1.0010 but less than 1.0030
on a single aliquot.
(f) Results indicating an invalid specimen. The laboratory shall
report a specimen as invalid when the laboratory obtains any one or
more of the following validity testing results:
(1) Inconsistent creatinine concentration and specific gravity
results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the
specific gravity is greater than 1.0010 but less than 1.0200 on the
initial and/or confirmatory specific gravity test, the specific gravity
is less than or equal to 1.0010 on both the initial and confirmatory
specific gravity tests and the creatinine concentration is equal to or
greater than 2 mg/dL on either or both the initial or confirmatory
creatinine tests);
(2) The pH is equal to or greater than 3 and less than 4.5, or
equal to or greater than 9 and less than 11, using either a
colorimetric pH test or pH meter for the initial test and a pH meter
for the confirmatory test on two separate aliquots;
(3) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test, or equal to or greater than 200
mcg/mL nitrite equivalents using a general oxidant colorimetric test
for both the initial test and the confirmatory test, or, using either
initial test, the nitrite concentration is equal to or greater than 200
mcg/mL but less than 500 mcg/mL using a different confirmatory test
(e.g., multi-wavelength spectrophotometry, ion chromatography,
capillary electrophoresis) on two separate aliquots;
(4) The possible presence of chromium (VI) is determined using the
same chromium (VI) colorimetric test with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) for both the initial test and the
confirmatory test on two separate aliquots;
(5) The possible presence of a halogen (e.g., bleach, iodine,
fluoride) is determined using the same halogen colorimetric test with a
cutoff equal to or greater than the LOD for both the initial test and
the confirmatory test on two separate aliquots or relying on the odor
of the specimen as the initial test;
(6) The possible presence of glutaraldehyde is determined using the
same aldehyde test (aldehyde present) or the characteristic immunoassay
response is observed on one or more drug immunoassay tests for both the
initial test and the confirmatory test on two separate aliquots;
(7) The possible presence of an oxidizing adulterant is determined
by using the same general oxidant colorimetric test (with cutoffs equal
to or greater than 200 mcg/mL nitrite equivalents, equal to or greater
than 50 mcg/mL chromium (VI) equivalents, or a halogen concentration
equal to or greater than the LOD) for both the initial test and the
confirmatory test on two separate aliquots;
(8) The possible presence of a surfactant is determined using the
same surfactant colorimetric test with a cutoff equal to or greater
than 100 mcg/mL dodecylbenzene sulfonate equivalent for both the
initial test and the confirmatory test on two separate aliquots or a
foam/shake test for the initial test;
(9) Interference occurs on the immunoassay drug tests on two
separate aliquots (i.e., valid immunoassay drug test results cannot be
obtained);
(10) Interference with the drug confirmation assay occurs on at
least two separate aliquots of the specimen, and the laboratory is
unable to identify the interfering substance;
(11) The physical appearance of the specimen indicates that testing
may damage the laboratory's equipment; or
(12) The physical appearances of Bottles A and B (when a split
specimen collection is used) are clearly different, and either the test
result for Bottle A indicated it is an invalid specimen or the specimen
in Bottle A was screened negative for drugs, or both.
(g) Additional testing by a second laboratory. If the presence of
an interfering substance/adulterant is suspected that could make a test
result invalid, but it cannot be identified (e.g., a new adulterant),
laboratory personnel shall consult with the licensee's or other
entity's MRO and, with the MRO's agreement, shall send the specimen to
another HHS-certified laboratory that has the capability to identify
the suspected substance.
(h) More stringent validity test cutoff levels are prohibited.
Licensees and other entities may not specify more stringent cutoff
levels for validity tests than those specified in this section.
Sec. 26.163 Cutoff levels for drugs and drug metabolites.
(a) Initial drug testing. (1) HHS-certified laboratories shall
apply the following cutoff levels for initial testing of specimens to
determine whether they are negative for the indicated drugs and drug
metabolites, except if validity testing indicates that the specimen is
dilute or the licensee or other entity has established more stringent
cutoff levels:
[[Page 50656]]
Initial Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drug or metabolites (ng/mL)
------------------------------------------------------------------------
(i) Marijuana metabolites............................... 50
(ii) Cocaine metabolites................................ 300
(iii) Opiate metabolites................................ 2,000
(iv) Phencyclidine...................................... 25
(v) Amphetamines........................................ 1,000
------------------------------------------------------------------------
(2) If confirmatory validity testing indicates that a specimen is
dilute, the HHS-certified laboratory shall use analytical kits approved
by the Food and Drug Administration that have the lowest concentration
levels marketed for the technology(ies) being used to conduct initial
testing of the specimen for drugs or drug metabolites. The laboratory
shall compare the responses of the dilute specimen to the cutoff
calibrator in each of the drug classes. If the response is within 50
percent of the cutoff, the HHS-certified laboratory shall inform the
licensee's or other entity's MRO. At the licensee's or other entity's
discretion, as documented in the FFD program policies and procedures,
the MRO may direct the laboratory to test the specimen for drugs and/or
drug metabolites down to the confirmatory assay's limit of detection
(LOD). The laboratory shall report the results of the special analysis,
if requested, to the MRO.
(b) Confirmatory drug testing. (1) A specimen that is identified as
positive on an initial drug test must be subject to confirmatory
testing for the class(es) of drugs for which the specimen initially
tested positive. The HHS-certified laboratory shall apply the
confirmatory cutoff levels specified in this paragraph, except if
confirmatory validity testing indicates that the specimen is dilute or
the licensee or other entity has established more stringent cutoff
levels.
Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
------------------------------------------------------------------------
Cutoff level
Drug or metabolites (ng/mL)
------------------------------------------------------------------------
(i) Marijuana metabolite \1\............................ 15
(ii) Cocaine metabolite \2\............................. 150
(iii) Opiates:
(A) Morphine........................................ 2000
(B) Codeine......................................... 2000
(C) 6-acetylmorphine \3\............................ 10
(iv) Phencyclidine...................................... 25
(v) Amphetamines:
(A) Amphetamine..................................... 500
(B) Methamphetamine \4\............................. 500
------------------------------------------------------------------------
\1\ As delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ As benzoylecgonine.
\3\ Test for 6-AM when the confirmatory test shows a morphine
concentration exceeding 2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration equal to
or greater than 200 ng/mL.
(2) Each confirmatory drug test must provide a quantitative result.
When the concentration of a drug or metabolite exceeds the linear range
of the standard curve, the laboratory may record the result as
``exceeds the linear range of the test'' or as ``equal to or greater
than ,'' or
may dilute an aliquot of the specimen to obtain an accurate
quantitative result when the concentration is above the upper limit of
the linear range.
Sec. 26.165 Testing split specimens and retesting single specimens.
(a) Split specimens. (1) If a specimen has been split into Bottle A
and Bottle B at the collection site, and the specimen was not initially
tested at a licensee testing facility, then the HHS-certified
laboratory shall perform initial and confirmatory validity and drug
testing, if required, of the specimen in Bottle A.
(2) If a specimen was initially tested at a licensee testing
facility and non-negative results were obtained, then the HHS-certified
laboratory shall perform initial and confirmatory testing, if required,
of the specimen in Bottle A.
(3) At the licensee's or other entity's discretion, Bottle B must
either be forwarded to the laboratory or maintained in secure storage
by the licensee or other entity. If the specimen in Bottle A is free of
any evidence of drugs or drug metabolites, and is a valid specimen,
then the licensee, other entity, or laboratory may discard the specimen
in Bottle B.
(4) If initial and confirmatory test results from the specimen in
Bottle A are positive for one or more drugs or drug metabolites, or if
validity testing at the HHS-certified laboratory shows that the
specimen has been subject to adulteration, substitution, or other means
of subversion, the laboratory shall report the results to the MRO.
Within 3 business days (Monday through Friday, excluding holidays) of
being notified by the MRO that the donor's specimen yielded a non-
negative test result, the donor may request that the split specimen in
Bottle B be tested by another HHS-certified laboratory. The MRO shall
inform the donor of this option, and the specimen in Bottle B may be
tested only at the donor's request. The donor shall provide his or her
written permission for the testing of Bottle B and neither the
licensee, MRO, NRC, nor any other entity may order testing of Bottle B
without the donor's written permission.
(5) If the donor requests that the specimen in Bottle B be tested,
the HHS-certified laboratory shall forward Bottle B to a second HHS-
certified laboratory that did not test the specimen in Bottle A as soon
as reasonably practical and not more than one business day following
the day of the donor's request.
(6) The HHS-certified laboratory that tests the specimen in Bottle
B shall provide quantitative test results to the MRO and the MRO shall
provide them to the donor.
(b) Donor request to MRO for a retest of a single specimen. (1) For
a drug-positive, adulterated, or substituted result reported on a
single specimen of 30 mL or more which the donor submitted to the
licensee or other entity, a donor may request (through the MRO) that an
aliquot from the single specimen be tested by a second HHS-certified
laboratory to verify the result reported by the first laboratory. The
MRO shall inform the donor of the option for a retest and the donor
shall request the retest within 3 business days after notification by
the MRO of the non-negative test result. The donor shall provide his or
her written permission for the retest and neither the licensee, MRO,
NRC, nor any other entity may order retesting of the specimen without
the donor's written permission, except as provided in Sec. 26.185(m).
(2) For a single specimen that the laboratory has reported as
invalid, a donor may not request that an aliquot from the single
specimen be tested by a second HHS-certified laboratory. If the donor
requests testing of the specimen, the HHS-certified laboratory shall
forward the specimen to a second HHS-certified laboratory that did not
test the specimen as soon as reasonably practical and not more than one
business day following the day of the donor's request.
(c) Retesting a specimen for drugs. (1) The second laboratory shall
use its standard confirmatory drug test when retesting an aliquot of a
single specimen or testing Bottle B of a split specimen for the drug(s)
or drug metabolite(s) for which the first laboratory reported a
positive result(s).
(2) Because some drugs or drug metabolites may deteriorate during
storage, the retest by the second laboratory is not subject to a
specific drug cutoff level, but must provide data sufficient to confirm
the presence of the drug(s) or drug metabolite(s) down to the assay's
LOD.
(3) If the second laboratory fails to reconfirm the presence of the
drug(s) or drug metabolite(s) for which the first
[[Page 50657]]
laboratory reported a positive result(s), the second laboratory shall
attempt to determine the reason for not reconfirming the first
laboratory's findings by conducting specimen validity tests. The second
laboratory shall conduct the same specimen validity tests it would
conduct on a single specimen or the specimen in Bottle A of a split
specimen.
(4) The second laboratory shall report all results to the
licensee's or other entity's MRO.
(d) Retesting a specimen for adulterants. A second laboratory shall
use the appropriate confirmatory validity test and criteria specified
in Sec. 26.161(c) to reconfirm an adulterant result when retesting an
aliquot from a single specimen or when testing Bottle B of a split
specimen. The second laboratory may only conduct the confirmatory
validity test needed to reconfirm the adulterant result reported by the
first laboratory.
(e) Retesting a specimen for substitution. A second laboratory
shall use its confirmatory creatinine and confirmatory specific gravity
tests, when retesting an aliquot of a single specimen or testing Bottle
B of a split specimen, to reconfirm that the creatinine concentration
was less than 2 mg/dL and the specific gravity was less than or equal
to 1.0010 or equal to or greater than 1.0200. However, the second
laboratory shall apply the cutoff levels for a substituted result in
this part and shall report the results as non-confirmed if the second
laboratory's results exceed the original test cutoff parameters. The
second laboratory may only conduct the confirmatory creatinine and
specific gravity tests to reconfirm the substitution result reported by
the first laboratory.
(f) Management actions and sanctions. (1) If the MRO confirms a
non-negative test result(s) from the first HHS-certified laboratory and
the donor requests testing of Bottle B of a split specimen or retesting
of an aliquot from a single specimen, the licensee or other entity
shall administratively withdraw the individual's authorization on the
basis of the first confirmed non-negative test result until the results
of testing Bottle B or retesting an aliquot of the single specimen are
available and have been reviewed by the MRO. If the MRO reports that
the results of testing Bottle B or retesting the aliquot of a single
specimen confirm any of the original non-negative test result(s), the
licensee or other entity shall impose the appropriate sanctions
specified in Subpart D of this part. If the results of testing Bottle B
or retesting the aliquot of a single specimen are negative, the
licensee or other entity--
(i) May not impose any sanctions on the individual;
(ii) Shall eliminate from the tested individual's personnel and
other records any matter that could link the individual to the
temporary administrative action;
(iii) May not disclose the temporary administrative action in
response to a suitable inquiry conducted under the provisions of Sec.
26.63 or to any other inquiry or investigation required in this
chapter. To ensure that no records have been retained, access to the
system of files and records must be provided to personnel conducting
reviews, inquiries into allegations, or audits under the provisions of
Sec. 26.41, or to NRC inspectors; and
(iv) Shall provide the tested individual with a written statement
that the records specified in Sec. Sec. 26.213 and 26.215 have not
been retained and shall inform the individual in writing that the
temporary administrative action that was taken will not be disclosed
and need not be disclosed by the individual in response to requests for
self-disclosure of potentially disqualifying FFD information.
(2) If a donor requests that Bottle B be tested or that an aliquot
of a single specimen be retested, and either Bottle B or the single
specimen are not available due to circumstances outside of the donor's
control (including, but not limited to, circumstances in which there is
an insufficient quantity of the single specimen to permit retesting,
either Bottle B or the original single specimen is lost in transit to
the second HHS-certified laboratory, Bottle B has been lost), the MRO
shall cancel the test. The licensee or other entity shall eliminate
from the donor's personnel and other records any matter that could link
the donor to the original non-negative test result(s) and any temporary
administrative action, and may not impose any sanctions on the donor
for a cancelled test. If the original specimen was collected for
random, for-cause, or post-event testing, the licensee or other entity
shall document only that the test was performed and cancelled. If the
original specimen was collected for pre-access or followup testing, the
MRO shall direct the licensee or other entity to collect another
specimen for testing as soon as reasonably practical. If test results
from the second specimen collected are non-negative and the MRO
determines that the donor has violated the FFD policy, the licensee or
other entity shall impose the appropriate sanctions specified in
Subpart D of this part, but may not consider the original confirmed
non-negative test result in determining the appropriate sanctions.
Sec. 26.167 Quality assurance and quality control.
(a) Quality assurance program. Each HHS-certified laboratory shall
have a quality assurance program that encompasses all aspects of the
testing process, including, but not limited to, specimen accessioning,
chain of custody, security and reporting of results, initial and
confirmatory testing, certification of calibrators and controls, and
validation of analytical procedures. The performance characteristics
(e.g., accuracy, precision, LOD, limit of quantitation (LOQ),
specificity) of each test must be validated and documented for each
test. Validation of procedures must document that carryover does not
affect the donor's specimen results. Periodic re-verification of
analytical procedures is required. Quality assurance procedures must be
designed, implemented, and reviewed to monitor the conduct of each step
of the testing process.
(b) Calibrators and controls required. Each analytical run of
specimens for which an initial or confirmatory validity test, or an
initial or confirmatory drug test, is being performed must include the
appropriate calibrators and controls.
(c) Quality control requirements for performing initial and
confirmatory validity tests. (1) Requirements for performing creatinine
tests.
(i) The creatinine concentration must be measured to 1 decimal
place on both the initial and the confirmatory creatinine tests.
(ii) The initial creatinine test must have a calibrator at 2 mg/dL.
(iii) The initial creatinine test must have a control in the range
of 1-1.5 mg/dL, a control in the range of 3-20 mg/dL, and a control in
the range of 21-25 mg/dL.
(iv) The confirmatory creatinine test (performed on those specimens
with a creatinine concentration less than 2 mg/dL on the initial test)
must have a calibrator at 2 mg/dL, a control in the range of 1-1.5 mg/
dL, and a control in the range of 3-4 mg/dL.
(2) Requirements for performing specific gravity tests.
(i) The refractometer must report and display the specific gravity
to 4 decimal places, and must be interfaced with a laboratory
information management system (LIMS), or computer, and/or generate a
hard copy or digital electronic display to document the numerical
result.
(ii) The initial and confirmatory specific gravity tests must have
a calibrator or control at 1.0000.
[[Page 50658]]
(iii) The initial and confirmatory specific gravity tests must have
the following controls:
(A) One control targeted at 1.0020;
(B) One control in the range of 1.0040-1.0180; and
(C) One control equal to or greater than 1.0200 but not greater
than 1.0250.
(3) Requirements for performing pH tests.
(i) Colorimetric pH tests that have the dynamic range of 2-12 to
support the 3 and 11 pH cutoffs and pH meters must be capable of
measuring pH to 1 decimal place. Dipsticks, colorimetric pH tests, and
pH paper that have a narrow dynamic range and do not support the 2-12
pH cutoffs may be used only to determine whether initial validity tests
must be performed. At a minimum, pH screening tests must have the
following controls:
(A) One control below the lower decision point in use;
(B) One control between the decision points in use; and
(C) One control above the upper decision point in use.
(ii) An initial colorimetric pH test must have the following
calibrators and controls:
(A) One calibrator at 3;
(B) One calibrator at 11;
(C) One control in the range of 2-2.8;
(D) One control in the range 3.2-4;
(E) One control in the range of 4.5-9;
(F) One control in the range of 10-10.8;
(G) One control in the range of 11.2-12.
(iii) If a pH screening test is not used, an initial pH meter test
must have the following calibrators and controls:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One calibrator at 10;
(D) One control in the range of 2-2.8;
(E) One control in the range 3.2-4;
(F) One control in the range of 10-10.8; and
(G) One control in the range of 11.2-12.
(iv) If a pH screening test is used, an initial or confirmatory pH
meter test must have the following calibrators and controls when the
screening result indicates that the pH is below the lower decision
point in use:
(A) One calibrator at 4;
(B) One calibrator at 7;
(C) One control in the range of 2-2.8; and
(D) One control in the range 3.2-4.
(v) If a pH screening test is used, an initial or confirmatory pH
meter test must have the following calibrators and controls when the
screening result indicates that the pH is above the upper decision
point in use:
(A) One calibrator at 7;
(B) One calibrator at 10;
(C) One control in the range of 10-10.8; and
(D) One control in the range of 11.2-12.
(4) Requirements for performing oxidizing adulterant tests.
(i) Initial tests for oxidizing adulterants must include a
calibrator at the appropriate cutoff concentration for the compound of
interest, a control without the compound of interest (i.e., a certified
negative control), and at least one control with one of the compounds
of interest at a measurable concentration.
(ii) A confirmatory test for a specific oxidizing adulterant must
use a different analytical method than that used for the initial test.
Each analytical run must include an appropriate calibrator, a control
without the compound of interest (i.e., a certified negative control),
and a control with the compound of interest at a measurable
concentration.
(5) Requirements for performing nitrite tests. The initial and
confirmatory nitrite tests must have a calibrator at the cutoff
concentration, a control without nitrite (i.e., certified negative
urine), one control in the range of 200-400 mcg/mL, and one control in
the range of 500-625 mcg/mL.
(6) Requirements for performing ``other'' adulterant tests.
(i) The initial and confirmatory tests for any ``other'' adulterant
that may be identified in the future must satisfy the requirements in
Sec. 26.161(a).
(ii) The confirmatory test for ``other'' adulterants must use a
different analytical principle or chemical reaction than that used for
the initial test.
(iii) The initial and confirmatory tests for ``other'' adulterants
must include an appropriate calibrator, a control without the compound
of interest (i.e., a certified negative control), and a control with
the compound of interest at a measurable concentration.
(d) Quality control requirements for performing initial drug tests.
(1) Any initial drug test performed by an HHS-certified laboratory must
use an immunoassay that meets the requirements of the Food and Drug
Administration for commercial distribution. Non-instrumented
immunoassay testing devices that are pending HHS/Substance Abuse and
Mental Health Services Administration (SAMHSA) review and approval may
not be used for initial drug testing under this part.
(2) HHS-certified laboratories may perform multiple initial drug
tests for the same drug or drug class, provided that all tests meet the
cutoffs and quality control requirements of this part.
(3) Each analytical run of specimens for initial testing must
include--
(i) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(ii) At least one control fortified with a drug or drug metabolite
targeted at 25 percent above the cutoff;
(iii) At least one control fortified with a drug or drug metabolite
targeted at 75 percent of the cutoff;
(iv) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of
the cutoff (after acceptable values are obtained for the known
calibrators, those values will be used to calculate sample data);
(v) A minimum of 10 percent of the total specimens in each
analytical run must be quality control samples; and
(vi) One percent of each run, with a minimum of at least one
sample, must be the laboratory's blind quality control samples to
appear as routine specimens to the laboratory analysts.
(e) Quality control requirements for performing confirmatory drug
tests. (1) Confirmatory tests for drugs and drug metabolites must be
performed using gas chromatography/mass spectrometry (GC/MS) or other
confirmatory test methodologies that HHS-certified laboratories are
permitted to use in Federal workplace drug testing programs for this
purpose.
(2) At least 10 percent of the samples in each analytical run of
specimens must be calibrators and controls. Each analytical run of
specimens that are subjected to confirmatory testing must include--
(i) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(ii) Positive calibrator(s) and control(s) fortified with a drug or
drug metabolite;
(iii) At least one control fortified with a drug or drug metabolite
targeted at 25 percent above the cutoff; and
(iv) At least one calibrator or control that is targeted at or
below 40 percent of the cutoff.
(f) Blind performance testing. Each licensee and other entity shall
submit blind performance test samples to the HHS-certified laboratory.
(1) During the initial 90-day period of any contract with an HHS-
certified laboratory (not including rewritten or renewed contracts),
each licensee or other entity shall submit blind performance test
samples to each HHS-certified laboratory with whom it contracts in the
amount of at least 20 percent of the total number of specimens
submitted (up to a maximum of 100 blind performance specimens) or
[[Page 50659]]
30 blind performance test samples, whichever is greater.
(2) Following the initial 90-day period, the number of blind
performance test samples submitted per quarter must be a minimum of 1
percent of all specimens (up to a maximum of 100) or 10 blind
performance test samples, whichever is greater. Both during the initial
90-day period and quarterly thereafter, licensees and other entities
should attempt to submit blind performance test samples at a frequency
that corresponds to the submission frequency for other specimens.
(3) Approximately 15 percent of the blind performance test samples
submitted to the laboratory must be positive for one or more drugs per
sample so that all of the drugs for which the FFD program is testing
are included each quarter. The positive samples must be spiked only
with those drugs for which the FFD program is testing and spiked with
concentrations between 60-80 percent of the initial cutoff values for
the panel of drugs established herein, or of any lower cutoff values
established by the licensee or other entity. To challenge the HHS-
certified laboratory's ability to determine specimen validity, the
licensee or other entity shall submit blind samples each quarter that
are appropriately adulterated, diluted, or substituted, in the amount
of 5 percent of the specimens submitted that quarter or at least 3
samples per quarter (one each that is adulterated, diluted, or
substituted), whichever is greater.
(4) Approximately 80 percent of the blind performance test samples
submitted to the laboratory each quarter must be blank (i.e., certified
to contain no drug).
(5) Licensees and other entities shall use only blind performance
test samples that have been certified by the supplier to be negative
(i.e., as certified by immunoassay and confirmatory testing), drug
positive [i.e., certified by immunoassay and confirmatory testing to
contain one or more drug(s) or drug metabolite(s)], adulterated (i.e.,
certified to be adulterated with a specific adulterant using an
appropriate confirmatory validity test), or substituted (i.e., the
creatinine concentration and specific gravity satisfy the criteria for
a substituted specimen using confirmatory creatinine and specific
gravity tests, respectively). The supplier shall also provide the
expiration date for each blind performance test sample to ensure that
each quality control sample will give the expected result when it is
submitted and correctly tested by a laboratory before the expiration
date. In addition--
(i) Drug performance testing samples must satisfy, but are not
limited to, one of the following criteria:
(A) The drug or drug metabolite concentration in the sample must be
at least 20 percent above the designated cutoff for either the initial
drug test or the confirmatory drug test, depending upon which is to be
evaluated;
(B) For retest samples, the drug or drug metabolite concentration
may be as low as 40 percent of the cutoff;
(C) For routine samples, the drug or drug metabolite concentration
may be below the cutoff for special purposes;
(D) A negative sample may not contain the target drug analyte at a
concentration greater than 10 percent of the confirmatory cutoff; and
(E) Samples may be fortified with interfering substances.
(ii) Validity performance testing samples must satisfy, but are not
limited to, one of the following criteria:
(A) The nitrite concentration must be at least 20 percent above the
cutoff;
(B) The pH must be less than 2.75 or greater than 11.25;
(C) The concentration of an oxidant will be at a level sufficient
to challenge a laboratory's ability to identify and confirm the
oxidant;
(D) The creatinine concentration must be between 0 and 20 mg/dL;
and
(E) The specific gravity must be less than or equal to 1.0050 or
between 1.0170 and 1.0230.
(g) Errors in testing. The licensee or other entity shall ensure
that the HHS-certified laboratory investigates any testing errors or
unsatisfactory performance discovered in blind performance testing, in
the testing of actual specimens, or through the processing of reviews,
as well as any other errors or matters that could adversely reflect on
the testing process.
(1) Whenever possible, the investigation must determine relevant
facts and identify the root cause(s) of the testing or process error.
The licensee or other entity, and the HHS-certified laboratory, shall
take action to correct the causes of any errors or unsatisfactory
performance that are within their control. Sufficient records shall be
maintained to furnish evidence of activities affecting quality. The
licensee or other entity shall assure that the cause of the condition
is determined and the corrective action taken to preclude repetition.
The identification of the significant condition, the cause of the
condition, and the corrective action taken shall be documented and
reported to appropriate levels of management.
(2) Should a false positive error occur on a blind performance test
sample or on a regular specimen, the licensee or other entity shall
require the laboratory to take corrective action to minimize the
occurrence of the particular error in the future. If there is reason to
believe that the error could have been systematic, the licensee or
other entity may also require review and re-analysis of previously run
specimens.
(3) Should a false positive error occur on a blind performance test
sample and the error is determined to be technical or methodological,
the licensee or other entity shall instruct the laboratory to provide
all quality control data from the batch or analytical run of specimens
that included a false positive sample. In addition, the licensee or
other entity shall require the laboratory to retest all specimens that
analyzed as positive for that drug or metabolite, or as non-negative in
validity testing, from the time of final resolution of the error back
to the time of the last satisfactory performance test cycle. This
retesting must be documented by a statement signed by the laboratory's
certifying scientist. The licensee or other entity and the NRC also may
require an onsite review of the laboratory, which may be conducted
unannounced during any hours of operation of the laboratory.
(h) Accuracy. Volumetric pipettes and measuring devices must be
certified for accuracy or be checked by gravimetric, colorimetric, or
other verification procedures. Automatic pipettes and dilutors must be
checked for accuracy and reproducibility both before being placed in
service and periodically thereafter.
(i) Calibrators and controls. Laboratory calibrators and controls
must be prepared using pure drug reference materials, stock standard
solutions obtained from other laboratories, or standard solutions that
are obtained from commercial manufacturers and are properly labeled as
to content and concentration. Calibrators and controls may not be
prepared from the same stock solution. The standards and controls must
be labeled with the following dates: When received; when prepared or
opened; when placed in service; and when scheduled for expiration.
Sec. 26.169 Reporting results.
(a) The HHS-certified laboratory shall report test results to the
licensee's or other entity's MRO within 5 business days after receiving
the specimen from the licensee or other entity. Before reporting any
test result to the MRO, the laboratory's certifying scientist shall
certify the result as correct. The report must identify the substances
for which testing was performed; the results of the validity and drug
tests; the cutoff levels
[[Page 50660]]
for each; any indications of tampering, adulteration, or substitution
that may be present; the specimen identification number assigned by the
licensee or other entity; and the specimen identification number
assigned by the laboratory.
(b) The HHS-certified laboratory shall report as negative all
specimens that are negative on the initial or confirmatory drug and
validity tests. Specimens that test as non-negative on the confirmatory
analysis must be reported to the MRO as positive for a specific drug(s)
or drug metabolite(s), or as meeting the criteria for an adulterated,
substituted, or dilute specimen.
(c) If licensees or other entities specify cutoff levels for drugs
or drug metabolites that are more stringent than those specified in
this part, the laboratory need only conduct the more stringent tests
and shall report the results of the initial and confirmatory tests only
for the more stringent cutoff levels.
(d) For a specimen that is found to be dilute, adulterated, or
substituted, the laboratory shall report the specimen as dilute,
adulterated, or substituted and, when applicable, shall provide the MRO
with the numerical values that support the reported result. The MRO may
not disclose the numerical values to the licensee or other entity,
except as permitted in Sec. 26.37(b). If the numerical values for
creatinine are below the LOD, the laboratory shall report to the MRO
``creatinine none detected'' (i.e., substituted) along with the
numerical values. For a specimen that has an invalid result, the
laboratory shall contact the MRO and both will decide whether testing
by another certified laboratory would be useful in being able to report
a positive or adulterated result. Such contact may occur through any
secure electronic means (e.g., telephone, fax, e-mail). If no further
testing is necessary, the laboratory shall report the invalid result to
the MRO.
(e) The laboratory shall report all non-negative test results for a
specimen to the MRO. For example, a specimen may be both adulterated
and positive for one or more specific drugs.
(f) The laboratory shall provide numerical values for non-negative
confirmatory test results when the MRO requests such information. The
MRO's request may be either a general request covering all such results
or a specific case-by-case request. When the concentration of a drug,
metabolite, or adulterant exceeds the linear range of the standard
curve, the laboratory may report to the MRO that the quantitative value
``exceeds the linear range of the test,'' that the quantitative value
is ``equal to or greater than ,'' or may report an accurate quantitative value above
the upper limit of the linear range that was obtained by diluting an
aliquot of the specimen. The MRO may not disclose quantitative test
results to the licensee or other entity, but shall report only whether
the specimen was drug-positive (and for which analyte), adulterated,
substituted, invalid, or negative, except as permitted under Sec.
26.37(b). This paragraph does not preclude either the laboratory or the
MRO from providing program performance data, as required under Sec.
26.217.
(g) The laboratory shall routinely provide quantitative values for
confirmatory opiate test results for morphine or codeine that are
greater than or equal to 15,000 ng/mL, even if the MRO has not
requested quantitative values for the test result.
(h) The laboratory may transmit results to the MRO by various
electronic means (e.g., teleprinters, facsimile, or computer) in a
manner designed to ensure the confidentiality of the information. The
laboratory may not provide results verbally by telephone. The licensee
or other entity, directly or through the HHS-certified laboratory,
shall ensure the security of the data transmission and ensure only
authorized access to any data transmission, storage, and retrieval
system.
(i) For negative test results, the HHS-certified laboratory may
fax, courier, mail, or electronically transmit a computer-generated
electronic report and/or a legible image or copy of the completed
custody-and-control form to the MRO. However, for non-negative results,
the laboratory shall fax, courier, mail, or electronically transmit a
legible image or copy of the completed custody-and-control form to the
MRO.
(j) For a specimen that has a non-negative result, the laboratory
shall retain the original custody-and-control form and transmit to the
MRO a copy of the original custody-and-control form signed by a
certifying scientist.
(k) The HHS-certified laboratory shall provide to the licensee's or
other entity's official responsible for coordination of the FFD program
an annual statistical summary of urinalysis testing, which may not
include any personal identifying information. In order to avoid sending
data from which it is likely that information about a donor's test
result can be readily inferred, the laboratory may not send a summary
report if the licensee or other entity has fewer than 10 specimen test
results in a 1-year period. The summary report must include test
results that were reported within the year period. The laboratory shall
send the summary report to the licensee or other entity within 14
calendar days after the end of the 1-year period covered by the report.
The statistics must be presented either for the cutoff levels specified
in this part or for any more stringent cutoff levels that the licensee
or other entity may specify. The HHS-certified laboratory shall make
available quantitative results for all specimens tested when requested
by the NRC, licensee, or other entity for whom the laboratory is
performing drug-testing services. If the FFD program tests for
additional drugs beyond those listed in Sec. 26.31(d), the summary
must include drug test results for the additional drugs. The summary
report must contain the following information:
(1) Total number of specimens received;
(2) Number of specimens reported as--
(i) Negative, and
(ii) Negative and dilute;
(3) Number of specimens reported as positive on confirmatory tests
by drug or drug metabolite for which testing is conducted, including,
but not limited to--
(i) Marijuana metabolite;
(ii) Cocaine metabolite;
(iii) Opiates (total);
(A) Codeine,
(B) Morphine, and
(C) 6-AM;
(iv) Phencyclidine;
(v) Amphetamines (total);
(A) Amphetamine, and
(B) Methamphetamine;
(4) Total number of specimens reported as adulterated;
(5) Total number of specimens reported as substituted;
(6) Total number of specimens reported as drug positive and dilute;
and
(7) Total number of specimens reported as invalid.
Subpart H--Determining Fitness-for-Duty Policy Violations and
Determining Fitness
Sec. 26.181 Purpose.
This subpart contains requirements for determining whether a donor
has violated the FFD policy and for making a determination of fitness.
Sec. 26.183 Medical review officer.
(a) Qualifications. The MRO shall be knowledgeable of this part and
of the FFD policies of the licensees and other entities for whom the
MRO provides services. The MRO shall be a physician
[[Page 50661]]
holding either a Doctor of Medicine or Doctor of Osteopathy degree who
is licensed to practice medicine by any State or Territory of the
United States, the District of Columbia, or the Commonwealth of Puerto
Rico. By [insert date 2 years after publication of the final rule in
the Federal Register], the MRO shall have passed an examination
administered by a nationally recognized MRO certification board or
subspecialty board for medical practitioners in the field of medical
review of Federally mandated drug tests.
(b) Relationships. The MRO may be an employee of the licensee or
other entity or a contractor. However, the MRO may not be an employee
or agent of, or have any financial interest in, an HHS-certified
laboratory or a contracted operator of a licensee testing facility for
whom the MRO reviews drug test results. Additionally, the MRO may not
derive any financial benefit by having the licensee or other entity use
a specific drug testing laboratory or licensee testing facility
operating contractor and may not have any agreement with such parties
that may be construed as a potential conflict of interest.
(c) Responsibilities. The primary role of the MRO is to review and
interpret non-negative test results obtained through the licensee's or
other entity's testing program and to identify any evidence of
subversion of the testing process. The MRO is also responsible for
identifying any issues associated with collecting and testing
specimens, and for advising and assisting FFD program management in
planning and overseeing the overall FFD program.
(1) In carrying out these responsibilities, the MRO shall examine
alternate medical explanations for any non-negative test result. This
action may include, but is not limited to, conducting a medical
interview with the donor, reviewing the donor's medical history, or
reviewing any other relevant biomedical factors. The MRO shall review
all medical records that the donor may make available when a non-
negative test result could have resulted from responsible use of
legally prescribed medication, a documented condition or disease state,
or the demonstrated physiology of the donor.
(2) The MRO may only consider the results of tests of specimens
that are collected and processed in accordance with this part,
including the results of testing split specimens, in making his or her
determination, as long as those split specimens have been stored and
tested in accordance with the procedures described in this part.
(d) MRO staff. Individuals who provide administrative support to
the MRO may be employees of a licensee or other entity, employees of
the MRO, or employees of an organization with whom a licensee or other
entity contracts for MRO services.
(1) Direction of MRO staff activities. MROs shall be directly
responsible for all administrative, technical, and professional
activities of individuals who are serving MRO staff functions under his
or her direction.
(i) The duties of MRO staff must be maintained independent from any
other activity or interest of a licensee or other entity, in order to
protect the integrity of the MRO function and donors' privacy.
(ii) An MRO's responsibilities for directing MRO staff must
include, but are not limited to, ensuring that--
(A) The procedures being performed by MRO staff meet NRC
regulations and HHS' and professional standards of practice;
(B) Records and other donor personal information are maintained
confidential by MRO staff and are not released to other individuals or
entities, except as permitted under this part;
(C) Data transmission is secure; and
(D) Drug test results are reported to the licensee's or other
entity's designated reviewing official only in accordance with the
requirements of this part.
(iii) The MRO may not delegate any of his or her responsibilities
for directing MRO staff to any other individual or entity, except
another MRO.
(2) MRO staff responsibilities. MRO staff may perform routine
administrative support functions, including receiving test results,
reviewing negative test results, and scheduling interviews for the MRO.
(i) The staff under the direction of the MRO may receive, review,
and report negative test results to the licensee's or other entity's
designated representative.
(ii) The staff reviews of non-negative drug test results must be
limited to reviewing the custody-and-control form to determine whether
it contains any errors that may require corrective action and to ensure
that it is consistent with the information on the MRO's copy. The staff
may resolve errors in custody-and-control forms that require corrective
action(s), but shall forward the custody-and-control forms to the MRO
for review and approval of the resolution.
(iii) The staff may not conduct interviews with donors to discuss
non-negative drug test results nor request medical information from a
donor. Only the MRO may request and review medical information related
to a non-negative drug test result or other matter from a donor.
(iv) Staff may not report nor discuss any non-negative test results
received from the HHS-certified laboratory with any individuals other
than the MRO and other MRO staff.
Sec. 26.185 Determining a fitness-for-duty policy violation.
(a) MRO review required. A non-negative drug test result does not
automatically identify an individual as having used drugs in violation
of the NRC's regulations, or the licensee's or other entity's FFD
policy, or as having attempted to subvert the testing process. An
individual who has a detailed knowledge of possible alternate medical
explanations is essential to the review of the results. The MRO shall
review all non-negative test results from the HHS-certified laboratory
to determine whether the donor has violated the FFD policy before
reporting the results to the licensee's or other entity's designated
representative.
(b) Reporting of initial test results prohibited. Neither the MRO
nor MRO staff may report non-negative initial test results to the
licensee or other entity that are received from the HHS-certified
laboratory.
(c) Discussion with the donor. Before determining that a non-
negative test result or other occurrence is an FFD policy violation and
reporting it to the licensee or other entity, the MRO shall give the
donor an opportunity to discuss the test result or other occurrence
with the MRO, except as described in paragraph (d) of this section.
After this discussion, if the MRO determines that a non-negative test
result or other occurrence is an FFD policy violation, the MRO shall
immediately notify the licensee's or other entity's designated
representative.
(d) Donor unavailability. The MRO may determine that a non-negative
test result or other occurrence is an FFD policy violation without
having discussed the test result or other occurrence directly with the
donor in the following three circumstances:
(1) The MRO has made and documented contact with the donor and the
donor expressly declined the opportunity to discuss the test result or
other occurrence that may constitute an FFD policy violation;
(2) A representative of the licensee or other entity, or an MRO
staff member, has successfully made and documented contact with the
donor and has instructed him or her to contact the MRO, and more than
one business day has elapsed since the date on which the
[[Page 50662]]
licensee's representative or MRO's staff member successfully contacted
the donor; or
(3) The MRO, after making all reasonable efforts and documenting
the dates and time of those efforts, has been unable to contact the
donor. Reasonable efforts include, at a minimum, three attempts, spaced
reasonably over a 24-hour period, to reach the donor at the day and
evening telephone numbers listed on the custody-and-control form.
(e) Additional opportunity for discussion. If the MRO determines
that the donor has violated the FFD policy without having discussed the
non-negative test result or other occurrence directly with the donor,
the donor may, upon subsequent notification of the MRO determination
and within 30 days of that notification, present to the MRO information
documenting the circumstances, including, but not limited to, serious
illness or injury, which unavoidably prevented the donor from being
contacted by the MRO or a representative of the licensee or other
entity, or from contacting the MRO in a timely manner. On the basis of
this information, the MRO may reopen the procedure for determining
whether the donor's test result or other occurrence is an FFD policy
violation and permit the individual to present information related to
the issue. The MRO may modify the initial determination based on an
evaluation of the information provided.
(f) Review of invalid specimens. (1) If the HHS-certified
laboratory reports an invalid result, the MRO shall consult with the
laboratory to determine whether additional testing by another HHS-
certified laboratory may be useful in determining and reporting a drug-
positive, adulterated, or substituted test result. If the MRO and the
laboratory agree that further testing would be useful, the HHS-
certified laboratory shall forward the specimen to a second laboratory
for additional testing.
(2) If the MRO and the laboratory agree that further testing would
not be useful and there is no technical explanation for the result, the
MRO shall contact the donor and determine whether there is an
acceptable medical explanation for the invalid result. If there is an
acceptable medical explanation, the MRO shall report to the licensee or
other entity that the test result is not an FFD policy violation, but
that a negative test result was not obtained. If the medical reason for
the invalid result is, in the opinion of the MRO, a temporary
condition, the licensee or other entity shall collect a second urine
specimen from the donor as soon as reasonably practical and rely upon
the MRO's review of the test results from the second collection. The
second specimen collected for the purposes of this paragraph may not be
collected under direct observation. If the medical reason for the
invalid result would similarly affect the testing of another urine
specimen, the MRO may authorize an alternative method for drug testing.
Licensees and other entities may not impose sanctions for an invalid
test result due to a medical condition.
(3) If the MRO and the laboratory agree that further testing would
not be useful and there is no legitimate technical or medical
explanation for the invalid test result, the MRO shall require that a
second collection take place as soon as practical under direct
observation. The licensee or other entity shall rely upon the MRO's
review of the test results from the directly observed collection.
(g) Review of dilute specimens. (1) If the HHS-certified laboratory
reports that a specimen is dilute and that drugs or drug metabolites
were detected in the specimen at or above the cutoff levels specified
in this part or the licensee's or other entity's more stringent cutoff
levels, and the MRO determines that there is no legitimate medical
explanation for the presence of the drugs or drug metabolites in the
specimen, the MRO shall determine that the drug test results are
positive and that the donor has violated the FFD policy.
(2) If the MRO has reason to believe that the donor may have
diluted a specimen in a subversion attempt, the MRO may require the
laboratory to conduct confirmatory testing of the specimen at the LOD
for any drugs or drug metabolites as long as each drug class is
evaluated in accordance with Sec. 26.31(c)(1)(ii). For purposes of
this paragraph, the following circumstances are the exclusive grounds
constituting a reason to believe that the donor may have diluted the
specimen in a subversion attempt:
(i) The donor has presented, at this or a previous collection, a
urine specimen that the HHS-certified laboratory reported as being
substituted, adulterated, or invalid to the MRO and the MRO determined
that there is no adequate technical or medical explanation for the
result;
(ii) The donor has presented a urine specimen of 30 mL or more that
falls outside the required temperature range, even if a subsequent
directly observed collection was performed; and
(iii) The collector observed conduct clearly and unequivocally
indicating an attempt to dilute the specimen.
(3) If the dilute specimen was collected under direct observation
as required under Sec. 26.69, the MRO may require the laboratory to
conduct confirmatory testing at the LOD for any drugs or drug
metabolites, as long as each drug class is evaluated in accordance with
Sec. 26.31(c)(1)(ii).
(4) If the drugs detected in a dilute specimen are any opium,
opiate, or opium derivative (e.g., morphine/codeine), or if the drugs
or metabolites detected indicate the use of prescription or over-the-
counter medications, before determining that the donor has violated the
FFD policy under paragraph (a) of this section, the MRO or his/her
designee, who shall also be a licensed physician with knowledge of the
clinical signs of drug abuse, shall conduct the clinical examination
for abuse of these substances that is required in paragraph (j) of this
section. An evaluation for clinical evidence of abuse is not required
if the laboratory confirms the presence of 6-AM (i.e., the presence of
this metabolite is proof of heroin use) in the dilute specimen.
(h) Review of substituted specimens. (1) If the HHS-certified
laboratory reports a specimen as substituted (i.e., the creatinine
concentration is less than 2 mg/dL and the specific gravity is less
than or equal to 1.0010 or equal to or greater than 1.0200), the MRO
shall contact the donor and offer the donor an opportunity to provide a
legitimate medical explanation for the substituted result. The burden
of proof resides solely with the donor, who must provide legitimate
medical evidence within 5 business days that he or she produced the
specimen for which the HHS-certified laboratory reported a substituted
result. Any medical evidence must be submitted through a referral
physician who is experienced and qualified in the medical issues
involved. Claims of excessive hydration, or claims based upon
unsubstantiated personal characteristics, including, but not limited
to, race, gender, diet, and body weight, are not acceptable evidence
without medical studies which demonstrate that the donor did produce
the laboratory result.
(2) If the MRO determines that there is no legitimate medical
explanation for the substituted test result, the MRO shall report to
the licensee or other entity that the specimen was substituted.
(3) If the MRO determines that there is a legitimate medical
explanation for the substituted test result and no drugs or drug
metabolites were detected in the specimen, the MRO shall report to the
licensee or other entity that no FFD policy violation has occurred.
[[Page 50663]]
(i) Review of adulterated specimens. (1) If the HHS-certified
laboratory reports a specimen as adulterated with a specific substance,
the MRO shall contact the donor and offer the donor an opportunity to
provide a legitimate medical explanation for the adulterated result.
The burden of proof resides solely with the donor, who must provide
legitimate medical evidence within 5 business days that he or she
produced the adulterated result through normal human physiology. Any
medical evidence must be submitted through a referral physician
experienced and qualified in the medical issues involved.
(2) If the MRO determines there is no legitimate medical
explanation for the adulterated test result, the MRO shall report to
the licensee or other entity that the specimen is adulterated.
(3) If the MRO determines that there is no legitimate medical
explanation for the adulterated test result and no drugs or drug
metabolites were detected in the specimen, the MRO shall report to the
licensee or other entity that no FFD policy violation has occurred.
(j) Review for opiates, prescription and over-the-counter
medications. (1) If the MRO determines that there is no legitimate
medical explanation for a positive confirmatory test result for opiates
and before the MRO determines that the test result is a violation of
the FFD policy, the MRO or his/her designee, who shall also be a
licensed physician with knowledge of the clinical signs of drug abuse,
shall determine that there is clinical evidence, in addition to the
positive test result, that the donor has illegally used opium, an
opiate, or an opium derivative (e.g., morphine/codeine). This
requirement does not apply if the laboratory confirms the presence of
6-AM (i.e., the presence of this metabolite is proof of heroin use), or
the morphine or codeine concentration is equal to or greater than
15,000 ng/mL and the donor does not present a legitimate medical
explanation for the presence of morphine or codeine at or above this
concentration. The MRO may not determine that the consumption of food
products is a legitimate medical explanation for the presence of
morphine or codeine at or above this concentration.
(2) If the MRO determines that there is no legitimate medical
explanation for a positive test result for drugs other than opiates
that are commonly prescribed or included in over-the-counter
preparations (e.g., benzodiazepines in the first case, barbiturates in
the second) and are listed in the licensee's or other entity's panel of
substances to be tested, the MRO shall determine whether there is
clinical evidence, in addition to the positive test result, of abuse of
any of these substances or their derivatives.
(3) If the MRO determines that the donor has used another
individual's prescription medication, including a medication containing
opiates, and no clinical evidence of drug abuse is found, the MRO shall
report to the licensee or other entity that the donor has misused a
prescription medication. If the MRO determines that the donor has used
another individual's prescription medication and clinical evidence of
drug abuse is found, the MRO shall report to the licensee that the
donor has violated the FFD policy.
(4) In determining whether a legitimate medical explanation exists
for a positive test result for opiates, prescription or over-the-
counter medications, the MRO may consider the use of a medication from
a foreign country. The MRO shall exercise professional judgment
consistently with the following principles:
(i) There can be a legitimate medical explanation only with respect
to a drug that is obtained legally in a foreign country;
(ii) There can be a legitimate medical explanation only with
respect to a drug that has a legitimate medical use. Use of a drug of
abuse (e.g., heroin, PCP) or any other substance that cannot be viewed
as having a legitimate medical use can never be the basis for a
legitimate medical explanation, even if the drug is obtained legally in
a foreign country; and
(iii) Use of the drug can form the basis of a legitimate medical
explanation only if it is used consistently with its proper and
intended medical purpose.
(5) The MRO may not consider consumption of food products,
supplements, or other preparations containing substances that may
result in a positive drug test result, including, but not limited to
supplements containing hemp products or coca leaf tea, as a legitimate
medical explanation for the presence of drugs or drug metabolites in
the urine specimen above the cutoff levels specified in Sec. 26.163 or
a licensee's or other entity's more stringent cutoff levels.
(6) The MRO may not consider the use of any drug contained in
Schedule I of section 202 of the Controlled Substances Act [21 U.S.C.
812] as a legitimate medical explanation for a positive confirmatory
drug test result, even if the drug may be legally prescribed and used
under State law.
(k) Results consistent with legitimate drug use. If the MRO
determines that there is a legitimate medical explanation for a
positive drug test result, and that the use of a drug identified
through testing was in the manner and at the dosage prescribed, and the
results do not reflect a lack of reliability or trustworthiness, then
the donor has not violated the licensee's or other entity's FFD policy.
The MRO shall report to the licensee or other entity that no FFD policy
violation has occurred. The MRO shall further evaluate the positive
test result and medical explanation to determine whether use of the
drug and/or the medical condition poses a potential risk to public
health and safety as a result of the individual being impaired while on
duty. If the MRO determines that such a risk exists, he or she shall
ensure that a determination of fitness is performed.
(l) Retesting authorized. Should any question arise as to the
accuracy or validity of a non-negative test result, only the MRO is
authorized to order retesting of an aliquot of the original specimen.
Retesting must be performed by a second HHS-certified laboratory. The
MRO is also the only individual who may authorize a reanalysis of an
aliquot of the original specimen or an analysis of any split specimen
(Bottle B) in response to a written request from the donor tested.
(m) Result scientifically insufficient. Based on the review of
inspection and audit reports, quality control data, multiple specimens,
and other pertinent results, the MRO may determine that a non-negative
test result is scientifically insufficient for further action and may
declare that a drug or validity test result is not an FFD policy
violation, but that a negative test result was not obtained. In this
situation, the MRO may request retesting of the original specimen
before making this decision. The MRO is neither expected nor required
to request such retesting, unless in the sole opinion of the MRO, such
retesting is warranted. The MRO may request that the reanalysis be
performed by the same laboratory, or that an aliquot of the original
specimen be sent for reanalysis to another HHS-certified laboratory.
The licensee testing facility and the HHS-certified laboratory shall
assist in this review process, as requested by the MRO, by making
available the individual(s) responsible for day-to-day management of
the licensee testing facility or the HHS-certified laboratory, or other
individuals who are forensic toxicologists or who have equivalent
forensic experience in urine drug testing, to provide specific
consultation as required by the MRO.
(n) Evaluating results from a second laboratory. After a second
laboratory tests an aliquot of a single specimen or the split (Bottle
B) specimen, the MRO
[[Page 50664]]
shall take the following actions if the second laboratory reports the
following results:
(1) If the second laboratory reconfirms any drug-positive test
results, the MRO may report an FFD policy violation to the licensee or
other entity;
(2) If the second laboratory reconfirms any non-negative validity
test results, the MRO may report an FFD policy violation to the
licensee or other entity;
(3) If the second laboratory does not reconfirm the drug-positive
test results, the MRO shall report that no FFD policy violation has
occurred; or
(4) If the second laboratory does not reconfirm the non-negative
validity test results, the MRO shall report that no FFD policy
violation has occurred.
(o) Re-authorization after a first violation for a drug-positive
test result. The MRO is responsible for reviewing drug test results
from an individual whose authorization was terminated or denied for a
first violation of the FFD policy involving a confirmed positive drug
test result and who is being considered for re-authorization. In order
to determine whether subsequent positive confirmatory drug test results
represent new drug use or remaining metabolites from the drug use that
initially resulted in the FFD policy violation, the MRO shall request
from the HHS-certified laboratory, and the laboratory shall provide,
quantitation of the test results and other information necessary to
make the determination. If the drug for which the individual first
tested positive was marijuana and the confirmatory assay for delta-9-
tetrahydrocannabinol-9-carboxylic acid yields a positive result, the
MRO shall determine whether the confirmatory test result indicates
further marijuana use since the first positive test result, or whether
the test result is consistent with the level of delta-9-
tetrahydrocannabinol-9-carboxylic acid that would be expected if no
further marijuana use had occurred. If the test result indicates that
no further marijuana use has occurred since the first positive test
result, then the MRO shall declare the drug test result as negative.
(p) Time to complete MRO review. The MRO shall complete his or her
review of non-negative test results and, in those instances in which
the MRO determines that the donor has violated the licensee's or other
entity's FFD policy, notify licensee or other entity's designated
representative within 10 days of an initial non-negative test result.
The MRO shall notify the licensee or other entity of the FFD policy
violation in writing and in a manner designed to ensure the
confidentiality of the information.
Sec. 26.187 Substance abuse expert.
(a) Implementation. By [insert date 2 years after publication of
the final rule in the Federal Register], substance abuse experts (SAEs)
upon whom licensees and other entities rely to make determinations of
fitness under this part shall meet the requirements of this section.
(b) Credentials. An SAE shall have at least one of the following
credentials:
(1) A licensed physician;
(2) A licensed or certified social worker;
(3) A licensed or certified psychologist;
(4) A licensed or certified employee assistance professional; or
(5) An alcohol and drug abuse counselor certified by the National
Association of Alcoholism and Drug Abuse Counselors Certification
Commission (NAADAC) or by the International Certification Reciprocity
Consortium/Alcohol and Other Drug Abuse (ICRC).
(c) Basic knowledge. An SAE shall be knowledgeable in the following
areas:
(1) Demonstrated knowledge of and clinical experience in the
diagnosis and treatment of alcohol and controlled-substance abuse
disorders;
(2) Knowledge of the SAE function as it relates to the public's
interests in the job duties performed by individuals who are subject to
this part; and
(3) Knowledge of this part and any changes thereto.
(d) Qualification training. SAEs shall receive qualification
training on the following subjects:
(1) Background, rationale, and scope of this part;
(2) Key drug testing requirements of this part, including specimen
collection, laboratory testing, MRO review, and problems in drug
testing;
(3) Key alcohol testing requirements of this part, including
specimen collection, the testing process, and problems in alcohol
tests;
(4) SAE qualifications and prohibitions;
(5) The role of the SAE in making determinations of fitness and the
return-to-duty process, including the initial evaluation, referrals for
education and/or treatment, the followup evaluation, continuing
treatment recommendations, and the followup testing plan;
(6) Procedures for SAE consultation and communication with
licensees or other entities, MROs, and treatment providers;
(7) Reporting and recordkeeping requirements of this part; and
(8) Issues that SAEs confront in carrying out their duties under
this part.
(e) Continuing education. During each 3-year period following
completion of initial qualification training, the SAE shall complete
continuing education consisting of at least 12 continuing professional
education hours relevant to performing SAE functions.
(1) This continuing education must include material concerning new
technologies, interpretations, recent guidance, rule changes, and other
information about developments in SAE practice pertaining to this part,
since the time the SAE met the qualification training requirements of
this section.
(2) Continuing education activities must include documented
assessment tools to assist in determining that the SAE has learned the
material.
(f) Documentation. The SAE shall maintain documentation showing
that he or she currently meets all requirements of this section. The
SAE shall provide this documentation upon request to NRC
representatives, licensees, or other entities who are relying upon or
contemplating relying upon the SAE's services.
(g) Responsibilities and prohibitions. The SAE shall evaluate
individuals who have violated the substance abuse provisions of an FFD
policy and make recommendations concerning education, treatment, return
to duty, followup drug and alcohol testing, and aftercare. The SAE is
not an advocate for the licensee or other entity, or the individual.
The SAE's function is to protect public health and safety and the
common defense and security by professionally evaluating the individual
and recommending appropriate education/treatment, follow-up tests, and
aftercare.
(1) The SAE is authorized to make determinations of fitness in at
least the following three circumstances:
(i) When potentially disqualifying FFD information has been
identified regarding an individual who has applied for authorization
under this part;
(ii) When an individual has violated the substance abuse provisions
of a licensee's or other entity's FFD policy; and
(iii) When an individual may be impaired by alcohol, prescription
or over-the-counter medications, or illegal drugs.
(2) Upon determining the best recommendation for assisting the
individual, the SAE shall serve as a referral source to assist the
individual's entry into an education and/or treatment program.
[[Page 50665]]
(i) To prevent the appearance of a conflict of interest, the SAE
may not refer an individual requiring assistance to his or her private
practice or to a person or organization from whom the SAE receives
payment or in which the SAE has a financial interest. The SAE is
precluded from making referrals to entities with whom the SAE is
financially associated.
(ii) There are four exceptions to the prohibitions contained in the
preceding paragraph. The SAE may refer an individual to any of the
following providers of assistance, regardless of his or her
relationship with them:
(A) A public agency (e.g., treatment facility) operated by a state,
county, or municipality;
(B) A person or organization under contract to the licensee or
other entity to provide alcohol or drug treatment and/or education
services (e.g., the licensee's or other entity's contracted treatment
provider);
(C) The sole source of therapeutically appropriate treatment under
the individual's health insurance program (e.g., the single substance
abuse in-patient treatment program made available by the individuals'
insurance coverage plan); or
(D) The sole source of therapeutically appropriate treatment
reasonably available to the individual (e.g., the only treatment
facility or education program reasonably located within the general
commuting area).
Sec. 26.189 Determination of fitness.
(a) A determination of fitness is the process whereby it is
determined whether there are indications that an individual may be in
violation of the licensee's or other entity's FFD policy or is
otherwise unable to safely and competently perform his or her duties. A
determination of fitness must be made by a licensed or certified
professional who is appropriately qualified and has the necessary
clinical expertise, as verified by the licensee or other entity, to
evaluate the specific fitness issues presented by the individual. A
professional called upon by the licensee or other entity may not
perform a determination of fitness regarding fitness issues that are
outside of his or her specific areas of expertise. The types of
professionals and the fitness issues for which they are qualified to
make determinations of fitness include, but are not limited to, the
following:
(1) An SAE who meets the requirements of Sec. 26.187 may determine
the fitness of an individual who may have engaged in substance abuse
and shall determine an individual's fitness to be granted authorization
following an unfavorable termination or denial of authorization under
this part, but may not be qualified to assess the fitness of an
individual who may have experienced mental illness, significant
emotional stress, or other mental or physical conditions that may cause
impairment but are unrelated to substance abuse, unless the SAE has
additional qualifications for addressing those fitness issues;
(2) A clinical psychologist may determine the fitness of an
individual who may have experienced mental illness, significant
emotional stress, or cognitive or psychological impairment from causes
unrelated to substance abuse, but may not be qualified to assess the
fitness of an individual who may have a substance abuse disorder,
unless the psychologist is also an SAE;
(3) A psychiatrist may determine the fitness of an individual who
is taking psychoactive medications in accordance with one or more valid
prescription(s), but may not be qualified to assess potential
impairment attributable to substance abuse, unless the psychiatrist has
had specific training to diagnose and treat substance abuse disorders;
(4) A physician may determine the fitness of an individual who may
be ill, injured, fatigued, taking medications in accordance with one or
more valid prescriptions, or using over-the-counter medications, but
may not be qualified to assess the fitness of an individual who may
have a substance abuse disorder, unless the physician is also an SAE;
and
(5) As a physician with specialized training, the MRO may determine
the fitness of an individual who may have engaged in substance abuse or
may be ill, injured, fatigued, taking medications in accordance with
one or more valid prescriptions, and/or using over-the-counter
medications, but may not be qualified to assess an individual's fitness
to be granted authorization following an unfavorable termination or
denial of authorization under this part, unless the MRO is also an SAE.
(b) A determination of fitness must be made in at least the
following circumstances:
(1) When there is an acceptable medical explanation for a non-
negative test result, but there is a basis for believing that the
individual could be impaired while on duty;
(2) Before making return-to-duty recommendations after an
individual's authorization has been terminated unfavorably or denied in
accordance with a licensee's or other entity's FFD policy;
(3) Before an individual is granted authorization when potentially
disqualifying FFD information is identified and has not previously been
evaluated by another licensee or entity who is subject to this part;
and
(4) When potentially disqualifying FFD information is otherwise
identified and the licensee's or other entity's reviewing official
concludes that a determination of fitness is warranted under Sec.
26.69.
(c) A determination of fitness that is conducted ``for cause'' must
be conducted through face-to-face interaction between the subject
individual and the professional making the determination. Electronic
means of communication may not be used.
(1) If there is neither conclusive evidence of an FFD policy
violation nor a significant basis for concern that the individual may
be impaired while on duty, then the individual must be determined to be
fit for duty.
(2) If there is no conclusive evidence of an FFD policy violation
but there is a significant basis for concern that the individual may be
impaired while on duty, then the subject individual must be determined
to be unfit for duty. This result does not constitute a violation of
this part nor of the licensee's or other entity's FFD policy, and no
sanctions may be imposed. However, the professional who made the
determination of fitness shall consult with the licensee's or other
entity's management personnel to identify the actions required to
ensure that any possible limiting condition does not represent a threat
to workplace or public health and safety. Licensee or other entity
management personnel shall implement the required actions. When
appropriate, the subject individual may also be referred to the EAP.
(d) Neither the individual nor licensees and other entities may
seek a second determination of fitness if a determination of fitness
under this part has already been performed by a qualified professional
employed by or under contract to the licensee or other entity. After
the initial determination of fitness has been made, the professional
may modify his or her evaluation and recommendations based on new or
additional information from other sources including, but not limited
to, the subject individual, another licensee or entity, or staff of an
education or treatment program. Unless the professional who made the
initial determination of fitness is no longer employed by or under
contract to the licensee or other entity, only that professional is
authorized to modify the evaluation and recommendations. When
reasonably practicable, licensees and other entities shall assist in
arranging for consultation between the new
[[Page 50666]]
professional and the professional who is no longer employed by or under
contract to the licensee or other entity, to ensure continuity and
consistency in the recommendations and their implementation.
Subpart I--Managing Fatigue
Sec. 26.195 Applicability.
The requirements in this subpart apply only to the licensees and
other entities identified in Sec. 26.3(a) and (d).
Sec. 26.197 General provisions.
(a) Policy. Licensees shall establish a policy for the management
of fatigue and incorporate it into the written policy required in Sec.
26.27(b).
(b) Procedures. In addition to the procedures required in Sec.
26.27(c), licensees shall develop, implement, and maintain procedures
that--
(1) Describe the process to be followed when any individual who is
subject to an FFD program under Sec. 26.25(a)(1) or (2) makes a self-
declaration that he or she is not fit to safely and competently perform
his or her duties for any part of a working tour as a result of
fatigue. The procedure must--
(i) Describe the individual's and licensee's responsibilities
related to self-declaration;
(ii) Describe requirements for establishing controls and conditions
under which an individual may be permitted or required to perform work
after that individual declares that he or she is not fit due to
fatigue; and
(iii) Describe the process to be followed if the individual
disagrees with the results of a fatigue assessment that is required
under Sec. 26.201(a)(2);
(2) Describe the process for implementing the work hour controls
required under Sec. 26.199 for the individuals who are performing the
duties listed in Sec. 26.199(a);
(3) Describe the process to be followed in conducting fatigue
assessments under Sec. 26.201; and
(4) Describe the sanctions, if any, that the licensee may impose on
an individual following a fatigue assessment.
(c) Training and examinations. Licensees shall add the following
KAs to the content of the training that is required in Sec. 26.29(a)
and the comprehensive examination required in Sec. 26.29(b):
(1) Knowledge of the contributors to worker fatigue, circadian
variations in alertness and performance, indications and risk factors
for common sleep disorders, shiftwork strategies for obtaining adequate
rest, and the effective use of fatigue countermeasures; and
(2) Ability to identify symptoms of worker fatigue and contributors
to decreased alertness in the workplace.
(d) Recordkeeping. Licensees shall retain the following records for
at least 3 years or until the completion of all related legal
proceedings, whichever is later:
(1) Records of work hours for individuals who are subject to the
work hour controls in Sec. 26.199;
(2) The documentation of waivers that is required in Sec.
26.199(d)(3)(iv), including the bases for granting the waivers;
(3) The documentation of work hour reviews that is required in
Sec. 26.199(j)(3);
(4) The documentation of fatigue assessments that is required in
Sec. 26.201(g); and
(5) Documentation of the collective work hours of each job duty
group, as calculated in accordance with Sec. 26.199(b)(2).
(e) Reporting. Licensees shall include the following information in
the annual FFD program performance report required under Sec. 26.217:
(1) A summary of the number of instances during the previous
calendar year in which the licensee waived any of the work hour
controls specified in Sec. 26.199(d)(1) and (d)(2) for individuals
within each job duty group in Sec. 26.199(a). The report must
include--
(i) Only those waivers under which work was performed; and
(ii) Each work hour control that was waived in Sec. 26.199(d)(1)
and (d)(2), including all of the work hour controls that were waived
for any single extended work period for which it was necessary to waive
more than one work hour control;
(2) The collective work hours of any job duty group listed in Sec.
26.199(a) that exceeded an average of 48 hours per person per week in
any averaging period during the previous calendar year, in accordance
with Sec. 26.199(f)(3) and (f)(5). The report must also include--
(i) The dates that defined the averaging period(s) during which
collective work hours exceeded 48 hours per person per week;
(ii) The job duty group that exceeded the collective work hours
limit; and
(iii) The conditions that caused the job duty group's collective
work hours to exceed the collective work hours limit; and
(3) The number of fatigue assessments conducted during the previous
calendar year, the conditions under which each fatigue assessment was
conducted (i.e., self-declaration, for cause, post-event, followup),
and the management actions, if any, resulting from each fatigue
assessment.
Sec. 26.199 Work hour controls.
(a) Individuals subject to work hour controls. Any individual who
performs duties within the following job duty groups is subject to the
requirements of this section:
(1) Operating or on-site directing of the operation of systems and
components that a risk-informed evaluation process has shown to be
significant to public health and safety;
(2) Performing maintenance or on-site directing of the maintenance
of structures, systems, and components that a risk-informed evaluation
process has shown to be significant to public health and safety;
(3) Performing Health Physics or Chemistry duties required as a
member of the on-site emergency response organization minimum shift
complement;
(4) Performing the duties of a Fire Brigade member who is
responsible for understanding the effects of fire and fire suppressants
on safe shutdown capability; and
(5) Performing security duties as an armed security force officer,
alarm station operator, response team leader, or watchperson,
hereinafter referred to as security personnel.
(b) Calculating work hours. (1) Individual work hours. For the
purposes of this subpart, licensees shall calculate an individual's
work hours as the amount of time that an individual performs any duties
for a licensee who is subject to this subpart, including all within-
shift break times and rest periods during which there are no reasonable
opportunities or accommodations appropriate for restorative sleep, but
excluding shift turnover.
(i) Shift turnover includes only those activities that are
necessary to safely transfer information and responsibilities between
two or more individuals between shifts. Shift turnover activities may
include, but are not limited to, discussions of the status of plant
equipment, and the status of ongoing activities, such as extended tests
of safety systems and components. Licensees may not exclude work hours
worked during turnovers between individuals within a shift period due
to rotations or relief within a shift. Activities that licensees may
not exclude from work hours calculations also include, but are not
limited to, shift holdovers to cover for late arrivals of incoming
shift members; early arrivals of individuals for meetings, training, or
pre-shift briefings for special evolutions;
[[Page 50667]]
and holdovers for interviews needed for event investigations.
(ii) Other than shift turnover, only that portion of a break or
rest period during which there is a reasonable opportunity and
accommodations for restorative sleep may be excluded from the
licensee's calculation of an individual's work hours.
(iii) Licensees need not calculate the work hours of an individual
who is qualified to perform the job duties listed in paragraph (a) of
this section but has not performed such duties during the applicable
calculation period. However, if the individual begins or resumes
performing any of the job duties listed in paragraph (a) of this
section, the licensee shall include in the calculation of the
individual's work hours all work hours worked, including hours worked
performing duties that are not listed in paragraph (a) of this section,
and control the individual's work hours in accordance with the
requirements of paragraph (d) of this section.
(2) Collective work hours. For the purposes of this subpart,
licensees shall calculate collective work hours as the average number
of work hours worked among each group of individuals who perform the
duties listed in paragraph (a) of this section, within an averaging
period that may not exceed 13 weeks, as follows:
(i) Licensees may define broad job duty groups comprised of
individuals who perform the job duties listed in paragraph (a) of this
section, or may define smaller groups of individuals who perform
similar duties. The groups must collectively include all individuals
who perform the job duties listed in paragraph (a) of this section;
(ii) Licensees shall include in the average for each job duty group
the work hours of any individual who performs the job duties of the
group at the licensee's site, except if, during the averaging period
the individual worked less than 75 percent of the group's normally
scheduled hours;
(iii) The days included in an averaging period must be consecutive
or separated only by days that licensees are permitted to exclude from
the collective work hour calculation under Sec. 26.199(f)(1) through
(f)(3) and (f)(5), (h), and (i);
(iv) Licensees shall include within an averaging period all days
that are not excluded from collective work hour controls under Sec.
26.199(f)(1) through (f)(3) and (f)(5), (h), and (i); and
(v) Licensees may not include in the collective work hour
calculation for an averaging period any work hours that are included in
a collective work hour calculation for any other averaging period.
(c) Work hours scheduling. Licensees shall schedule the work hours
of individuals who are subject to this section consistent with the
objective of preventing impairment from fatigue due to the duration,
frequency, or sequencing of successive shifts.
(d) Work hour controls for individuals. Licensees shall control the
work hours of individuals, as follows:
(1) Except as permitted under paragraph (d)(3) of this section,
licensees shall ensure that any individual's work hours do not exceed
the following limits:
(i) 16 work hours in any 24-hour period;
(ii) 26 work hours in any 48-hour period; and
(iii) 72 work hours in any 7-day period.
(2) Licensees shall ensure that individuals have adequate rest
breaks. For the purposes of this subpart, a break is defined as an
interval of time that falls between successive work periods, during
which the individual does not perform any duties for the licensee other
than shift turnover. At a minimum, licensees shall ensure that
individuals who are subject to this section have the following breaks:
(i) A 10-hour break between successive work periods or an 8-hour
break between successive work periods when a break of less than 10
hours is necessary to accommodate a crew's scheduled transition between
work schedules or shifts;
(ii) A 24-hour break in any 7-day period; and
(iii) A 48-hour break in any 14-day period, except during the first
14 days of any plant outage if the individual is performing the job
duties listed in paragraph (a)(1) through (a)(4) of this section.
(3) Licensees may grant a waiver of the individual work hour
controls in paragraphs (d)(1) and (d)(2) of this section, as follows:
(i) In order to grant a waiver, the licensee shall meet both of the
following requirements:
(A) An operations shift manager determines that the waiver is
necessary to mitigate or prevent a condition adverse to safety, or a
security shift manager determines that the waiver is necessary to
maintain the security of the facility, or a site senior-level manager
with requisite signature authority makes either determination; and
(B) A supervisor, who is qualified to direct the work to be
performed by the individual and trained in accordance with the
requirements of Sec. Sec. 26.29 and 26.197(c), assesses the individual
face to face and determines that there is reasonable assurance that the
individual will be able to safely and competently perform his or her
duties during the additional work period for which the waiver will be
granted. At a minimum, the assessment must address the potential for
acute and cumulative fatigue considering the individual's work history
for at least the past 14 days, the potential for circadian degradations
in alertness and performance considering the time of day for which the
waiver will be granted, the potential for fatigue-related degradations
in alertness and performance to affect risk-significant functions, and
whether any controls and conditions must be established under which the
individual will be permitted to perform work;
(ii) To the extent practicable, licensees shall rely upon the
granting of waivers only to address circumstances that could not have
been reasonably controlled;
(iii) Licensees shall ensure that the timing of the face-to-face
supervisory assessment that is required in paragraph (d)(3)(i)(B) of
this section supports a valid assessment of the potential for worker
fatigue during the time the individual will be performing work under
the waiver. Licensees may not perform the face-to-face assessment more
than four hours before the individual begins performing any work under
the waiver; and
(iv) Licensees shall document the bases for individual waivers. The
documented basis for a waiver must include a description of the
circumstances that necessitate the waiver, a statement of the scope of
work and time period for which the waiver is approved, and the bases
for the determinations required in paragraph (d)(3)(i) of this section.
(e) Self-declarations during extended work hours. If an individual
is performing, or being assessed for, work under a waiver of the
requirements contained in paragraphs (d)(1) and (d)(2) of this section
and declares that, due to fatigue, he or she is unable to safely and
competently perform his or her duties, the licensee shall immediately
stop the individual from performing any duties listed in paragraph (a)
of this section, except if the individual is required to continue
performing those duties under other requirements of this chapter. If
the subject individual must continue performing the duties listed in
paragraph (a) of this section until relieved, the licensee shall
immediately take action to relieve the individual. Following the self-
declaration or relief
[[Page 50668]]
from performing the duties listed in paragraph (a) of this section, as
applicable, the licensee--
(1) May reassign the individual to duties other than those listed
in paragraph (a) of this section, but only if the results of a fatigue
assessment, conducted in accordance with the requirements of Sec.
26.201, indicate that the individual is fit to safely and competently
perform those other duties; and
(2) Shall permit or require the individual to take a rest break of
at least 10 hours before the individual returns to performing any
duties listed in paragraph (a) of this section.
(f) Collective work hour limits. In addition to controlling
individuals' work hours in accordance with paragraph (d) of this
section, licensees shall control the collective work hours of each
group of individuals who are performing similar job duties, as listed
in paragraph (a) of this section. Licensees shall ensure that the
collective work hours of each job duty group do not exceed an average
of 48 hours per person per week in any averaging period, except as
follows:
(1) The licensee need not impose the collective work hour controls
required in this paragraph on the job duty groups specified in
paragraphs (a)(1) through (a)(4) of this section during the first 8
weeks of a plant outage;
(2) For job duty groups comprised of security personnel--
(i) The group work hour average(s) may not exceed 60 hours per
person per week during the first 8 weeks of a plant outage or a planned
security system outage;
(ii) The group work hour average(s) may not exceed 60 hours per
person per week during the actual conduct of force-on-force tactical
exercises (i.e., licensee exercises and NRC-observed exercises);
(iii) The licensee need not impose any collective work hour
controls for the first 8 weeks of an unplanned security system outage
or an increased threat condition;
(iv) If an increase in threat condition occurs while the site is in
any plant outage or a planned security system outage and the increased
threat condition persists for a period of 8 weeks or less, the licensee
need not impose collective work hour controls on security personnel for
the duration of the increased threat condition. However, if during any
such outage, the threat condition returns to the least significant
threat condition that was in effect at any time within the past 8
weeks, then the licensee shall limit the collective work hours of
security personnel to an average of 60 hours per person per week for
the first 8 weeks of the outage for the periods prior to and following
the increased threat condition, and shall limit the collective work
hours of security personnel to an average of 48 hours per person per
week following the first 8 weeks of the outage;
(v) If additional increases in threat condition occur during an
unplanned security system outage or increased threat condition, the
relaxation of the collective work hour limits that is permitted in
paragraph (f)(2)(iii) of this section may be extended with each
increase in the threat condition, but only for a period that is the
shorter of either the duration of the increased threat condition or 8
weeks;
(vi) If the threat condition decreases during an unplanned security
system outage or increased threat condition, the applicability of the
relaxation of the collective work hour limits that is permitted in
paragraph (f)(2)(iii) of this section must based upon the date upon
which the current threat condition was last entered as a result of an
increase;
(3) The collective work hours of any job duty group listed in
paragraph (a) of this section may exceed an average of 48 hours per
person per week in one averaging period if all of the following
conditions are met:
(i) The circumstances that cause the group's collective work hours
to exceed 48 hours per person per week cannot be reasonably controlled;
(ii) The group's collective work hours do not exceed 54 hours per
person per week; and
(iii) The additional work hours that result in the group's
collective work hours exceeding 48 hours per person per week are worked
only to address the circumstances that the licensee could not have
reasonably controlled.
(4) The collective work hours of any job duty group may not exceed
48 hours per person per week if the collective work hours for the job
duty group exceeded 48 hours per person per week--
(i) In the previous averaging period; or
(ii) In any other averaging period that ended within the past 26
weeks.
(5) Licensees may also exceed any collective work hour limits in
this paragraph if the licensee has received prior approval from the NRC
of a written request that includes, at a minimum,--
(i) A description of the specific circumstances that require the
licensee to exceed the applicable collective work hour limit, the job
duty group(s) affected, and the collective work hours limit(s) to be
exceeded;
(ii) A statement of the period of time during which it will be
necessary to exceed the collective work hour limit(s); and
(iii) A description of the fatigue mitigation strategies,
including, but not limited to, rest break requirements and work hour
limits, that the licensee will implement to ensure that the individuals
affected will be fit to safely and competently perform their duties.
(g) Successive plant outages. If two or more plant outages occur at
the licensee's site and the interval(s) between successive outages is
less than 2 weeks, the licensee shall apply the requirements in
paragraphs (d)(2)(iii), (f)(1), (f)(2)(i), and (f)(2)(iv) of this
section based upon the number of days that have elapsed since the first
plant outage in the series began.
(h) Common defense and security. Licensees need not meet the
requirements of this section when informed in writing by the NRC that
these requirements, or any subset thereof, are waived for security
personnel in order to assure the common defense and security, for the
duration of the period defined by the NRC.
(i) Plant emergencies. Licensees need not meet the requirements of
paragraphs (c) through (f) of this section during declared emergencies,
as defined in the licensee's emergency plan.
(j) Reviews. Licensees shall review the control of work hours for
individuals who are subject to this subpart for each averaging period.
Licensees shall complete this review within 30 days of the end of the
averaging period. If any outages or increased threat conditions
occurred since the licensee completed the most recent review, the
licensee shall include in the review an assessment of the control of
work hours during the outages or increased threat conditions. Licensees
shall--
(1) Review the work hours and performance of individuals to assess
the effectiveness of the licensee's work hour controls in achieving the
objective of reasonable assurance that fatigue due to work hours does
not compromise individuals' abilities to safely and competently perform
their duties. At a minimum, the licensee's review must address--
(i) Individuals who were granted more than one waiver during the
review period;
(ii) Individuals who were assessed for fatigue in accordance with
Sec. 26.201 during the review period;
(iii) Individuals who performed the job duties listed in paragraph
(a) of this section whose average work hours per week exceeded 54 hours
during any averaging period for which the
[[Page 50669]]
collective work hour limit is 48 hours in this section; and
(iv) Any security personnel whose average work hours per week
exceeded 66 hours in any averaging periods for which the collective
work hours limit in this section is 60 hours per person per week;
(2) Review individuals' hours worked and the waivers under which
work was performed to assess staffing adequacy for all jobs subject to
the work hour controls of this section;
(3) Document the methods used to conduct these reviews and the
results of the reviews; and
(4) Record, trend, and correct, under the licensee's corrective
action program, any problems identified in maintaining control of work
hours consistent with the specific requirements and performance
objectives of this part.
Sec. 26.201 Fatigue assessments.
(a) Licensees shall ensure that fatigue assessments are conducted
under the following conditions:
(1) For-cause. In addition to any other test or determination of
fitness that may be required under Sec. Sec. 26.31(c) and 26.77, a
fatigue assessment must be conducted in response to an observed
condition of impaired individual alertness creating a reasonable
suspicion that an individual is not fit to safely and competently
perform his or her duties, except if the condition is observed during
an individual's break period. If the observed condition is impaired
alertness with no other behaviors or physical conditions creating a
reasonable suspicion of possible substance abuse, then the licensee
need only conduct a fatigue assessment. If the licensee has reason to
believe that the observed condition is not due to fatigue, the licensee
need not conduct a fatigue assessment;
(2) Self-declaration. A fatigue assessment must be conducted in
response to an individual's self-declaration to his or her supervisor
that he or she is not fit to safely and competently perform his or her
duties for any part of a working tour because of fatigue, except if,
following the self-declaration, the licensee permits or requires the
individual to take a rest break of at least 10 hours before the
individual returns to duty;
(3) Post-event. A fatigue assessment must be conducted in response
to events requiring post-event drug and alcohol testing as specified in
Sec. 26.31(c). Licensees may not delay necessary medical treatment in
order to conduct a fatigue assessment; and
(4) Followup. If a fatigue assessment was conducted for cause or in
response to a self-declaration, and the licensee returns the individual
to duty following a rest break of less than 10 hours in duration, the
licensee shall reassess the individual for fatigue as well as the need
to implement controls and conditions before permitting the individual
to resume performing any job duties.
(b) Either a supervisor or a staff member of the FFD program, who
is trained in accordance with the requirements of Sec. 26.29 and Sec.
26.197(c), shall conduct the fatigue assessment face to face with the
individual whose alertness may be impaired.
(1) In the case of a fatigue assessment conducted for cause, the
individual who observed the condition of impaired alertness may not
conduct the fatigue assessment.
(2) In the case of a post-event fatigue assessment, the individual
who conducts the fatigue assessment may not have--
(i) Performed or directed the work activities during which the
event occurred;
(ii) Performed, within 24 hours before the event occurred, a
fatigue assessment of the individuals who were performing or directing
the work activities during which the event occurred; and
(iii) Evaluated or approved a waiver of the limits specified in
Sec. 26.199(d)(1) and (2) for any of the individuals who were
performing or directing the work activities during which the event
occurred, if the event occurred while such individuals were performing
work under that waiver.
(c) A fatigue assessment must provide the information necessary for
management decisions and actions in response to the circumstance that
initiated the assessment.
(1) At a minimum, the fatigue assessment must address the following
factors:
(i) Acute fatigue;
(ii) Cumulative fatigue; and
(iii) Circadian variations in alertness and performance.
(2) Individuals shall provide complete and accurate information
that may be required by the licensee to address the factors listed in
paragraph (c)(1) of this section. Licensees shall limit any inquiries
to obtaining from the subject individual only the personal information
that may be necessary to assess the factors listed in paragraph (c)(1)
of this section.
(d) The licensee may not conclude that fatigue had not or will not
degrade the individual's ability to safely and competently perform his
or her duties solely on the basis that the individual's work hours have
not exceeded any of the limits specified in Sec. 26.199(d)(1) or that
the individual has had the minimum rest breaks required in Sec.
26.199(d)(2), as applicable.
(e) Following a fatigue assessment, the licensee shall determine
and implement the controls and conditions, if any, that are necessary
to permit the individual to resume performing duties for the licensee,
including the need for a rest break.
(f) Licensees shall document the results of any fatigue assessments
conducted, the circumstances that necessitated the fatigue assessment,
and any controls and conditions that were implemented.
Subpart J--Recordkeeping and Reporting Requirements
Sec. 26.211 General provisions.
(a) Each licensee and other entity who is subject to this part
shall maintain records and submit certain reports to the NRC. Records
that are required by the regulations in this part must be retained for
the period specified by the appropriate regulation. If a retention
period is not otherwise specified, these records must be retained until
the Commission terminates the facility's license, certificate, or other
regulatory approval.
(b) All records may be stored and archived electronically, provided
that the method used to create the electronic records meets the
following criteria:
(1) Provides an accurate representation of the original records;
(2) Prevents the alteration of any archived information and/or data
once it has been committed to storage; and
(3) Permits easy retrieval and re-creation of the original records.
Sec. 26.213 Recordkeeping requirements for licensees and other
entities.
(a) Each licensee and other entity who is subject to this part
shall retain the following records for at least 5 years after the
licensee or other entity terminates or denies an individual's
authorization or until the completion of all related legal proceedings,
whichever is later:
(1) Records of self-disclosures, employment histories, and suitable
inquiries that are required under Sec. Sec. 26.55, 26.57, 26.59, and
26.69 that result in the granting of authorization;
(2) Records pertaining to the determination of a violation of the
FFD policy and related management actions;
(3) Documentation of the granting and termination of authorization;
and
(4) Records of any determinations of fitness conducted under Sec.
26.189.
(b) Each licensee and other entity who is subject to this part
shall retain the
[[Page 50670]]
following records for at least 3 years or until the completion of all
related legal proceedings, whichever is later:
(1) Records of FFD training and examinations conducted under Sec.
26.29; and
(2) Records of audits, audit findings, and corrective actions taken
under Sec. 26.41.
(c) Licensees and other entities shall ensure the retention and
availability of records pertaining to any 5-year denial of
authorization under Sec. 26.75(c), (d), or (e)(2) and any permanent
denial of authorization under Sec. 26.75(b) and (g) for at least 40
years or until, upon application, the NRC determines that the records
are no longer needed.
(d) Licensees and other entities shall retain any superseded
versions of the written FFD policy and procedures required under
Sec. Sec. 26.27, 26.39, and 26.197(b) for at least 5 years or until
completion of all legal proceedings related to an FFD violation that
may have occurred under the policy and procedures, whichever is later.
(e) Licensees and other entities shall retain written agreements
for the provision of services under this part for the life of the
agreement or until completion of all legal proceedings related to an
FFD policy violation that involved those services, whichever is later.
(f) Licensees and other entities shall retain records of the
background investigations, credit and criminal history checks, and
psychological assessments of FFD program personnel, conducted under
Sec. 26.31(b)(1)(ii), for the length of the individual's employment by
or contractual relationship with the licensee or other entity, or until
the completion of all related legal proceedings, whichever is later.
(g) If a licensee's or other entity's FFD program includes tests
for drugs in addition to those specified in this part, as permitted
under Sec. 26.31(d)(1), or uses more stringent cutoff levels than
those specified in this part, as permitted under Sec. 26.31(d)(3), the
licensee or other entity shall retain documentation certifying the
scientific and technical suitability of the assays and cutoff levels
used, as required under Sec. 26.31(d)(1)(i) and (d)(3)(iii)(C),
respectively, for the period of time during which the FFD program
follows these practices or until the completion of all related legal
proceedings, whichever is later.
Sec. 26.215 Recordkeeping requirements for collection sites, licensee
testing facilities, and laboratories certified by the Department of
Health and Human Services.
(a) Collection sites providing services to licensees and other
entities, licensee testing facilities, and HHS-certified laboratories
shall maintain and make available documentation of all aspects of the
testing process for at least 2 years or until the completion of all
legal proceedings related to a determination of an FFD violation,
whichever is later. This 2-year period may be extended upon written
notification by the NRC or by any licensee or other entity for whom
services are being provided.
(b) Documentation that must be retained includes, but is not
limited to, the following:
(1) Personnel files, including training records, for all
individuals who have been authorized to have access to specimens, but
are no longer under contract to or employed by the collection site,
licensee testing facility, or HHS-certified laboratory;
(2) Chain-of-custody documents (other than forms recording
specimens with negative test results and no FFD violations or
anomalies, which may be destroyed after appropriate summary information
has been recorded for program administration purposes);
(3) Quality assurance and quality control records;
(4) Superseded procedures;
(5) All test data (including calibration curves and any
calculations used in determining test results);
(6) Test reports;
(7) Records pertaining to performance testing;
(8) Records pertaining to the investigation of testing errors or
unsatisfactory performance discovered in blind performance testing, in
the testing of actual specimens, or through the processing of appeals
and MRO reviews, as well as any other errors or matters that could
adversely reflect on the integrity of the testing process,
investigation findings, and corrective actions taken, where applicable;
(9) Performance records on certification inspections;
(10) Records of preventative maintenance on licensee testing
facility instruments;
(11) Records that summarize any test results that the MRO
determined to be scientifically insufficient for further action;
(12) Either printed or electronic copies of computer-generated
data;
(13) Records that document the dates, times of entry and exit,
escorts, and purposes of entry of authorized visitors, maintenance
personnel, and service personnel who have accessed secured areas of
licensee testing facilities and HHS-certified laboratories; and
(14) Records of the inspection, maintenance, and calibration of
EBTs.
Sec. 26.217 Fitness-for-duty program performance data.
(a) Licensees and other entities shall collect and compile FFD
program performance data for each FFD program that is subject to this
part.
(b) The FFD program performance data must include the following
information:
(1) The random testing rate;
(2) Drugs for which testing is conducted and cutoff levels,
including results of tests using lower cutoff levels and tests for
drugs not included in the HHS panel;
(3) Populations tested (i.e., individuals in applicant status,
permanent licensee employees, C/Vs);
(4) Number of tests administered and results of those tests sorted
by population tested (i.e., individuals in applicant status, permanent
licensee employees, C/Vs);
(5) Conditions under which the tests were performed, as defined in
Sec. 26.31(c);
(6) Substances identified;
(7) Number of subversion attempts by type; and
(8) Summary of management actions.
(c) Licensees and other entities who have a licensee-approved FFD
program shall analyze the data at least annually and take appropriate
actions to correct any identified program weaknesses. Records of the
data, analyses, and corrective actions taken must be retained for at
least 3 years or until the completion of any related legal proceedings,
whichever is later.
(d) Any licensee or other entity who terminates an individual's
authorization or takes administrative action on the basis of the
results of a positive initial drug test for marijuana or cocaine shall
also report these test results in the annual summary by processing
stage (i.e., initial testing at the licensee testing facility, testing
at the HHS-certified laboratory, and MRO determinations). The report
must also include the number of terminations and administrative actions
taken against individuals for the reporting period.
(e) Licensees and other entities shall submit the FFD program
performance data (for January through December) to the NRC annually,
before March 1 of the following year.
(f) Licensees and other entities may submit the FFD program
performance data in a consolidated report, as long as the report
presents the data separately for each site.
(g) Each C/V who maintains a licensee-approved drug and alcohol
testing program is subject to the reporting requirements of this
section and shall submit the required
[[Page 50671]]
information either directly to the NRC or through the licensee(s) or
other entities to whom the C/V provided services during the year.
Licensees, other entities, and C/Vs shall share information to ensure
that the information is reported completely and is not duplicated in
reports submitted to the NRC.
Sec. 26.219 Reporting requirements.
(a) Required reports. Each licensee and entity who is subject to
this part shall inform the NRC of significant violations of the FFD
policy, significant FFD program failures, and errors in drug and
alcohol testing. These events must be reported under this section,
rather than under the provisions of 10 CFR 73.71.
(b) Significant FFD policy violations or programmatic failures. The
following significant FFD policy violations and programmatic failures
must be reported to the NRC Operations Center by telephone within 24
hours after the licensee or other entity discovers the violation:
(1) The use, sale, distribution, possession, or presence of illegal
drugs, or the consumption or presence of alcohol within a protected
area;
(2) Any acts by any person licensed under 10 CFR Parts 52 and/or 55
to operate a power reactor, as well as any acts by SSNM transporters,
FFD program personnel, or any supervisory personnel who are authorized
under this part, if such acts--
(i) Involve the use, sale, or possession of a controlled substance;
(ii) Result in a determination that the individual has violated the
licensee's or other entity's FFD policy (including subversion as
defined in Sec. 26.5); or
(iii) Involve the consumption of alcohol within a protected area or
while performing the job duties that require the individual to be
subject to this part;
(3) Any intentional act that casts doubt on the integrity of the
FFD program; and
(4) Any programmatic failure, degradation, or discovered
vulnerability of the FFD program that may permit undetected drug or
alcohol use or abuse by individuals within a protected area, or by
individuals who are assigned to perform job duties that require them to
be subject to this part.
(c) Drug and alcohol testing errors. (1) Within 30 days of
completing an investigation of any testing errors or unsatisfactory
performance discovered in blind performance testing at either a
licensee testing facility or an HHS-certified laboratory, in the
testing of actual specimens, or through the processing of reviews under
Sec. 26.39 and MRO reviews under Sec. 26.185, as well as any other
errors or matters that could adversely reflect on the integrity of the
random selection or testing process, the licensee or other entity shall
submit to the NRC a report of the incident and corrective actions taken
or planned. If the error involves an HHS-certified laboratory, the NRC
shall ensure that HHS is notified of the finding.
(2) Should a false positive error occur on a blind performance test
sample submitted to an HHS-certified laboratory, the licensee or other
entity shall notify the NRC within 24 hours after discovery of the
error.
(3) Should a false negative error occur on a quality assurance
check of validity screening devices, as required in Sec. 26.137(b)(2)
and (3), the licensee or other entity shall notify the NRC within 24
hours after discovery of the error.
(d) Indicators of programmatic weaknesses. Licensees and other
entities shall document, trend, and correct non-reportable indicators
of FFD programmatic weaknesses under the licensee's or other entity's
corrective action program, but may not track or trend drug and alcohol
test results in a manner that would permit the identification of any
individuals.
Subpart K--Inspections, Violations, and Penalties
Sec. 26.221 Inspections.
(a) Each licensee and other entity who is subject to this part
shall permit duly authorized NRC representatives to inspect, copy, or
take away copies of its records and to inspect its premises,
activities, and personnel as may be necessary to accomplish the
purposes of this part.
(b) Written agreements between licensees or other entities and
their C/Vs must clearly show that--
(1) The licensee or other entity is responsible to the NRC for
maintaining an effective FFD program in accordance with this part; and
(2) Duly authorized NRC representatives may inspect, copy, or take
away copies of any licensee's, other entity's, or C/V's documents,
records, and reports related to implementation of the licensee's or
other entity's FFD program under the scope of the contracted
activities.
Sec. 26.223 Violations.
(a) An injunction or other court order may be obtained to prohibit
a violation of any provision of--
(1) The Atomic Energy Act of 1954, as amended;
(2) Title II of the Energy Reorganization Act of 1974; or
(3) Any regulation or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil
penalty imposed under section 234 of the Atomic Energy Act of 1954, for
violations of--
(1) Section 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of
the Act;
(2) Section 206 of the Energy Reorganization Act of 1974;
(3) Any rule, regulation, or order issued under these sections;
(4) Any term, condition, or limitation of any license issued under
these sections; or
(5) Any provisions for which a license may be revoked under section
186 of the Atomic Energy Act of 1954.
Sec. 26.225 Criminal penalties.
(a) Section 223 of the Atomic Energy Act of 1954, as amended,
provides for criminal sanctions for willful violation of, attempted
violation of, or conspiracy to violate, any regulation issued under
sections 161b, 161i, or 161o of the Act. For purposes of section 223,
all of the regulations in Part 26 are issued under one or more of
sections 161b, 161i, or 161o, except for the sections listed in
paragraph (b) of this section.
(b) The regulations in Part 26 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81,
26.121, 26.151, 26.181, 26.195, 26.223, and 26.225.
Dated at Rockville, Maryland, this 2nd day of August 2005.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
Appendix--Tables 1 and 2
Note: This appendix will not appear in The Code of Federal
Regulations.
Note: The Proposed Rule constitutes a complete revision of Part
26. Substantial changes frequently have been made between the new
section in the proposed rule and the derivation listed in Table 1.
[[Page 50672]]
Table 1.--Derivation Table for Part 26
------------------------------------------------------------------------
New section Based on
------------------------------------------------------------------------
26.1................................... 26.1 first sentence.
26.3(a)................................ 26.2(a).
26.3(b)................................ 26.1 (2nd sentence) and 26.2(a)
(1st sentence).
26.3(c)................................ 26.2(d).
26.3(d)................................ 26.23(a)(1).
26.3(e)................................ 26.2(c).
26.3(f)................................ 26.2(b).
26.5................................... 26.3 and Appendix A Subpart
1.2.
26.7................................... 26.4.
26.8................................... 26.8.
26.9................................... 26.6.
26.11.................................. NEW.
26.21.................................. 26.23(b).
26.23(a)............................... 26.10(a).
26.23(b)............................... 26.10(a).
26.23(c)............................... 26.10(b).
26.23(d)............................... 26.10(c).
26.23(e)............................... NEW.
26.25(a)(1)............................ 26.2(a) and 26.2(d).
26.25(a)(2)............................ 26.2(a) and 26.2(d).
26.25(a)(3)............................ 26.2(a) and 26.2(d).
26.25(a)(4)............................ NEW.
26.25(b)(1)............................ NEW.
26.25(b)(2)............................ 26.2(b).
26.25(b)(3)............................ 26.2(b).
26.25(c)............................... NEW.
26.25(d)............................... NEW.
26.27(a)............................... 26.20 1st paragraph.
26.27(b)(1)............................ 26.20(a).
26.27(b)(2)............................ NEW.
26.27(b)(3)............................ NEW.
26.27(b)(4)(i)......................... 26.20(a)(1).
26.27(b)(4)(ii)........................ 26.20(a)(2).
26.27(b)(5)............................ NEW.
26.27(b)(6)............................ 26.20(a).
26.27(b)(7)............................ 26.20(b).
26.27(b)(8)............................ 26.20(d).
26.27(b)(9)............................ NEW.
26.27(b)(10)........................... NEW.
26.27(b)(11)........................... NEW.
26.27(c)............................... 26.20(d).
26.29.................................. 26.21.
26.31.................................. 26.24.
26.33.................................. 26.22.
26.35.................................. 26.25.
26.37.................................. 26.29.
26.39.................................. 26.27.
26.41.................................. 26.80.
26.51.................................. 26.1.
26.53.................................. NEW.
26.55(a)............................... 26.27(a).
26.55(b)............................... NEW.
26.57(a)............................... NEW.
26.57(b)............................... NEW.
26.59.................................. NEW.
26.61(a)............................... 26.27(a)(1).
26.61(b)............................... 26.27(a)(2).
26.61(c)............................... NEW.
26.61(d)............................... 26.27(a)(4).
26.63(a)............................... NEW.
26.63(b)............................... NEW.
26.63(c)............................... NEW.
26.63(d)............................... 26.27(a)(3).
26.63(e)............................... NEW.
26.63(f)(1)............................ 26.71(c) and 26.27(b)(2)(vii).
26.63(f)(2)............................ NEW.
26.63(f)(3)............................ NEW.
26.65(a)............................... NEW.
26.65(b)............................... NEW.
26.65(c)(1)............................ 26.24(a)(1).
26.65(c)(2)............................ NEW.
26.65(d)............................... NEW.
[[Page 50673]]
26.65(e)............................... NEW.
26.65(f)............................... NEW.
26.65(g)............................... NEW.
26.65(h)............................... Appendix A Subpart B 2.9(c) and
26.27(a)(2).
26.67(a)............................... NEW.
26.67(b)............................... NEW.
26.67(c)............................... Appendix A Subpart B 2.9(c) and
26.27(a)(2).
26.69(a)............................... NEW.
26.69(b)(1)............................ 26.27(b)(4).
26.69(b)(2)............................ NEW.
26.69(b)(3)............................ 26.27(b)(4).
26.69(b)(4)............................ NEW.
26.69(b)(5)............................ NEW.
26.69(b)(6)............................ 26.27(b)(4).
26.69(b)(7)............................ 26.27(b)(4).
26.69(c)(1)............................ 26.27(a)(3).
26.69(c)(2)............................ NEW.
26.69(c)(3)............................ 26.27(a)(3).
26.69(c)(4)............................ NEW.
26.69(c)(5)............................ NEW.
26.69(d)............................... NEW.
26.69(e)............................... NEW.
26.69(f)............................... 26.27(a)(2).
26.71.................................. NEW.
26.75(a) (1st sentence)................ NEW.
26.75(a) (2nd sentence)................ 26.27(b) (1st sentence).
26.75(b)............................... NEW.
26.75(c)............................... 26.27(b)(3).
26.75(d)............................... 26.27(c).
26.75(e)............................... 26.27(b)(2).
26.75(f)............................... 26.27(b)(5).
26.75(g)............................... 26.27(b)(4).
26.75(h)............................... 26.24(d)(2).
26.77(a)............................... NEW.
26.77(b)(1)............................ 26.27(b)(1).
26.77(b)(2)............................ NEW.
26.77(b)(3)............................ NEW.
26.77(c)............................... 26.27(d).
26.81.................................. NEW.
26.83(a)............................... NEW.
26.83(b)............................... 26.24(b).
26.85(a)............................... Appendix A Subpart B 2.2(d).
26.85(b)............................... NEW.
26.85(c)............................... Appendix A Subpart B 2.2(d)(2)
(last sentence).
26.87(a)............................... Appendix A Subpart B 2.4(a).
26.87(b)............................... Appendix A Subpart B 2.4(f)
(1st sentence).
26.87(c)............................... Appendix A Subpart B 2.7(m).
26.87(d)............................... Appendix A Subpart B 2.4(c).
26.87(d)(1)............................ Appendix A Subpart B 2.4(e).
26.87(d)(2)............................ Appendix A Subpart B 2.4(c)
(2nd sentence).
26.87(d)(3)............................ Appendix A Subpart B 2.4(c).
26.87(e)............................... Appendix A Subpart B 2.4(g)(1).
26.87(f)(1)............................ Appendix A Subpart B 2.4(c).
26.87(f)(2)............................ Appendix A Subpart B 2.4(c).
26.87(f)(3)............................ Appendix A Subpart B 2.4(c).
26.87(f)(4)............................ NEW.
26.87(f)(5)............................ Appendix A Subpart B 2.4(c)(2).
26.89.................................. NEW.
26.91.................................. NEW.
26.93.................................. Appendix A Subpart B 2.4 and
new material.
26.95.................................. NEW.
26.97.................................. NEW.
26.99.................................. Appendix A Subpart B 2.4 and
new material.
26.101................................. Appendix A Subpart B 2.4 and
new material.
26.103................................. NEW.
26.105................................. Appendix A Subpart B 2.4 and
new material.
26.107................................. Appendix A Subpart B 2.4 and
new material.
26.109................................. NEW.
26.111................................. NEW.
26.113................................. Appendix A Subpart B 2.4 and
new material.
26.115................................. Appendix A Subpart B 2.4 and
new material.
26.117................................. Appendix A Subpart B 2.4 and
new material.
[[Page 50674]]
26.119................................. Appendix A Subpart B 2.4 and
new material.
26.121................................. NEW.
26.123................................. NEW.
26.133................................. Appendix A Subpart B 2.7(e)(1).
26.125(a).............................. Appendix A Subpart B 2.6(a).
26.125(b).............................. Appendix A Subpart B 2.6(b).
26.125(c).............................. Appendix A Subpart B 2.6(c).
26.127(a).............................. Appendix A Subpart B 2.2 1st
paragraph.
26.127(b).............................. Appendix A Subpart B 2.2(a) and
2.4(d).
26.127(b).............................. Appendix A Subpart B 2.4(d).
26.127(c).............................. Appendix A Subpart B 2.7(o)(1).
26.127(d).............................. Appendix A Subpart B 2.2(d).
26.127(e).............................. Appendix A Subpart B
2.7(o)(3)(iii).
26.129(a).............................. Appendix A Subpart B 2.4(c) and
2.7(a)(1).
26.129(b).............................. Appendix A Subpart B 2.2(b).
26.129(c).............................. Appendix A Subpart B 2.7(b)(2).
26.129(d).............................. Appendix A Subpart B 2.7(a)(2).
26.129(e).............................. Appendix A Subpart B 2.7(d) 1st
sentence.
26.129(f).............................. Appendix A Subpart B 2.7(c).
26.129(g).............................. Appendix A Subpart B 2.4(i).
26.129(h).............................. NEW.
26.131................................. Appendix A Subpart B 2.4(e).
26.133................................. Appendix A Subpart B 2.7.
26.135................................. Appendix A Subpart B 2.7(j).
26.137................................. Appendix A Subpart B 2.8(a).
26.137(e)(4-5)......................... Appendix A Subpart B 2.8(b).
26.137(e)(6-8)......................... Appendix A Subpart B 2.8(c).
26.137(f).............................. Appendix A Subpart B 2.8(e)(6).
26.137(g).............................. Appendix A Subpart B 2.7(o).
26.137(h).............................. Appendix A Subpart B 2.7(o).
26.139(a).............................. Appendix A Subpart B 2.7(g)(2).
26.139(b).............................. 26.24(d)(1).
26.139(c).............................. Appendix A Subpart B 2.7(o)(5).
26.139(d).............................. Appendix A Subpart B 2.7(g)(6).
26.139(e).............................. Appendix A Subpart B 2.7(g)(7).
26.139(f).............................. NEW.
26.151................................. NEW.
26.153(a).............................. 26.24(f) and Appendix A Subpart
D 4.1.
26.153(b).............................. Appendix A Subpart B 2.7(l)(2).
26.153(c).............................. Appendix A Subpart B 2.7(k).
26.153(d).............................. Appendix A Subpart A 1.1(2).
26.153(f)(5)........................... Appendix A Subpart B 2.3(1).
26.153(f) 1st paragraph................ Appendix A Subpart B 2.3 1st
paragraph.
26.155................................. Appendix A Subpart B 2.5.
26.157(a).............................. Appendix A Subpart B 2.2 1st
paragraph.
26.157(b).............................. Appendix A Subpart B 2.2(a) and
2.4(d).
26.157(c).............................. Appendix A Subpart B 2.7(o)(1).
26.157(d).............................. Appendix A Subpart B 2.2(d).
26.157(e).............................. Appendix A Subpart B
2.7(o)(3)(iii).
26.159(a).............................. Appendix A Subpart B 2.4(c) and
2.7(a)(1).
26.159(b).............................. Appendix A Subpart B 2.2(b).
26.159(c).............................. Appendix A Subpart B 2.7(b)(2).
26.159(d).............................. Appendix A Subpart B 2.7(a)(2).
26.159(e).............................. Appendix A Subpart B 2.7(a)(2).
26.159(f).............................. Appendix A Subpart B 2.4(i).
26.159(g).............................. NEW.
26.161................................. NEW.
26.163................................. Appendix A Subpart B 2.7(e)(1)
(substantially revised).
26.165................................. Appendix A Subpart B 2.7(j)
(substantially revised).
26.167(a) through (g).................. Appendix A Subpart B 2.8
(substantially revised).
26.167(h).............................. Appendix A Subpart B
2.7(o)(3)(i).
26.167(i).............................. Appendix A Subpart B 2.8(d).
26.169................................. Appendix A Subpart B 2.7(g)
(substantially revised).
26.181................................. NEW.
26.183(a).............................. 26.3 and Appendix A Subpart A
1.2 and Appendix. A Subpart B
2.9(b).
26.183(b).............................. NEW.
26.183(b)1st sentence.................. Appendix A Subpart B 2.9(b) 1st
sentence.
26.183(c).............................. 26.3 and Appendix A Subparts A
1.2,B 2.4 (J),B 2.9(a), and b
2.9(b).
26.183(d).............................. NEW.
26.185(a).............................. Appendix A Subpart B 2.9(a).
26.185(b).............................. Appendix A Subpart B 2.9(a)
last sentence.
26.185(c).............................. Appendix A Subpart B 2.9(c).
[[Page 50675]]
26.185(d).............................. NEW (more detailed than
Appendix A Subpart B 2.9(c)).
26.185(e).............................. NEW.
26.185(f).............................. NEW.
26.185(g).............................. NEW.
26.185(h).............................. NEW.
26.185(i).............................. NEW.
26.185(j)(1)........................... Appendix A Subpart B 2.9(d).
26.185(j)(2)........................... Appendix A Subpart B 2.9(d).
26.185(j)(3)........................... NEW.
26.185(j)(4)........................... NEW.
26.185(j)(5)........................... NEW.
26.185(j)(6)........................... NEW.
26.185(k).............................. Appendix A Subpart B 2.9(f).
26.185(l).............................. Appendix A Subpart B 2.9(e).
26.185(m).............................. Appendix A Subpart B 2.9(g).
26.185(n).............................. NEW.
26.185(o).............................. NEW.
26.185(p).............................. 26.24(e).
26.187................................. NEW.
26.189................................. NEW.
26.195................................. NEW.
26.197................................. NEW.
26.199................................. NEW.
26.201................................. NEW.
26.211(a).............................. NEW.
26.211(b).............................. NEW.
26.213(a)(1)........................... 26.71(a).
26.213(a)(2)........................... 26.71(b).
26.213(a)(3)........................... NEW.
26.213(a)(4)........................... NEW.
26.213(b)(1)........................... 26.21(b), 26.22(c), and
26.80(c).
26.213(b)(2)........................... 26.21(b), 26.22(c), and
26.80(c).
26.213(c).............................. 26.71(c).
26.213(d).............................. 26.2.
26.213(e).............................. 26.23(a).
26.213(f).............................. NEW.
26.213(g).............................. NEW.
26.215(a).............................. Appendix A Subpart B 2.7(n).
26.215(b).............................. NEW.
26.217(a).............................. 26.71(d).
26.217(b).............................. 26.71(d).
26.217(c).............................. 26.71(d).
26.217(d).............................. 26.71(d).
26.217(e).............................. 26.71(d).
26.217(f).............................. 26.71(d).
26.217(g).............................. NEW.
26.219(a).............................. NEW.
26.219(b)(1)........................... 26.73(a)(1).
26.219(b)(2)(i)........................ 26.73(a)(2)(i).
26.219(b)(2)(ii)....................... 26.73(a)(2)(ii) + (iv)
combined.
26.219(b)(2)(iii)...................... 26.73(a)(2)(iii).
26.219(b)(3)........................... NEW.
26.219(b)(4)........................... NEW.
26.219(c)(1)........................... Appendix A Subpart B 2.8(e)(4).
26.219(c)(2)........................... Appendix A Subpart B 2.8(e)(5).
26.219(c)(3)........................... NEW.
26.219(d).............................. NEW.
------------------------------------------------------------------------
Table 2.--Distribution Table for Part 26
------------------------------------------------------------------------
Current section Replaced by:
------------------------------------------------------------------------
26.1 (from beginning to ``programs'').. 26.1.
26.1 (following ``programs'').......... Deleted.
26.2(a) (first clause)................. 26.2(a) (to ``and'').
26.2(a) (balance of 1st sentence)...... 26.2(b) (from ``to'' to end).
26.2(a) (2nd sentence)................. 26.21 (1st sentence).
26.2(a) (3rd sentence to end).......... 26.25(a) (1)(2) and (3).
26.2(b) (1st sentence)................. 26.25(a).
26.2(b) (2nd sentence to end).......... 26.3(f).
26.2(c) (1st sentence)................. 26.3(e).
[[Page 50676]]
26.2(c) (from ``shall implement'' to 26.3(f).
end).
26.2(d)................................ 26.3(c).
26.3................................... 26.5.
26.4................................... 26.7.
26.6................................... 26.9.
26.8................................... 26.13.
26.10(a) (from beginning through 26.23(a).
``manner'').
26.10(a) (balance of 1st sentence)..... 26.23(b).
26.10(b)............................... 26.23(c).
26.10(c)............................... 26.23(d).
26.20 (introductory paragraph, 1st 26.27(a).
sentence).
26.20 (introductory paragraph, 2nd 26.213(d).
sentence).
26.20 (introductory paragraph, final 26.27(b) (sentence before
sentence). ``(1)'').
26.20(a)............................... 26.27(b).
26.20(b)............................... 26.27(b)(7).
26.20(c)............................... 26.27(c)(1).
26.20(d)............................... 26.27(c)(2).
26.20(e)............................... 26.27(c)(3).
26.20(f)............................... 26.27(d).
26.21(a)............................... 26.29(a).
26.21(b)............................... 26.29(c).
26.21(b) (last sentence)............... 26.213(b)(1).
26.22.................................. Deleted.
26.23(a)............................... 26.3(d) and 26.21.
26.23(b)............................... 26.21.
26.24(a) (first sentence to ``(1)'')... 26.31(a).
26.24(a) (balance of paragraph)........ 26.31(c) (substantially
revised).
26.24(b)............................... Subparts E, F, and G.
26.24(c)............................... 26.31(d).
26.24(d)............................... Subparts E, F, and G.
26.24(e)............................... Subpart H.
26.24(f)............................... 26.31(d)(3) and requirements in
Subpart G.
26.24(g)............................... 26.31(d)(4) and Subparts E, F,
and G.
26.25.................................. 26.35.
26.27(a)............................... Subpart C.
26.27(b)............................... Subpart D.
26.27(c)............................... Subpart D.
26.27(d)............................... 26.77(c).
26.28.................................. 26.39.
26.29.................................. 26.37.
26.70.................................. 26.221.
26.71.................................. 26.211, 26.213, and 26.215.
26.73.................................. 26.219 (substantially revised).
26.80.................................. 26.41 (substantially revised).
26.90.................................. 26.223.
26.91.................................. 26.225.
Appendix A Subpart A, 1.1(1)........... 26.3.
Appendix A Subpart A, 1.1(2)........... 26.31(d) (substantially
revised).
Appendix A Subpart A, 1.1(3)........... Subparts F and G.
Appendix A Subpart A, 1.2.............. 26.5.
Appendix A Subpart B, 2.1(a)........... 26.31(d)(1).
Appendix A Subpart B, 2.1(b)........... 26.31(d)(1).
Appendix A Subpart B.2.1(c)............ Subparts E, F, and G.
Appendix A Subpart B.2.1(d)............ 26.31(d)(6).
Appendix A Subpart B.2.1(e)............ 26.31.
Appendix A Subpart B.2.2 (Initial Subparts F and G.
paragraph).
Appendix A Subpart B.2.2(a), (b), and 26.115, 26.117, 26.129, 26.159,
(c). 26.169.
Appendix A Subpart B.2.2(d)(1), (2), 26.85.
and (3).
Appendix A Subpart B.2.2(d)(4)......... Deleted.
Appendix A Subpart B.2.3............... 26.31(b), and requirements in
Subparts E, F, and G.
Appendix A Subpart B.2.4(a)............ 26.87(a).
Appendix A Subpart B.2.4(b)............ 26.85.
Appendix A Subpart B.2.4(c)............ 26.87(d) and (f).
Appendix A Subpart B 2.4(d)............ 26.117.
Appendix A Subpart B 2.4(e)............ 26.87(d)(1).
Appendix A Subpart B 2.4(f) 1st 26.87(b).
sentence.
Appendix A Subpart B 2.4(f)(1) through 26.95 through 26.115 and
(f)(4). Subparts F and G.
Appendix A Subpart B 2.4(g)(1) through Subparts E, F, and G.
(g)(24).
Appendix A Subpart B 2.4(h) (1st 26.87(f)(5).
sentence).
Appendix A Subpart B 2.4(h) (balance of 26.113, 26.117, and 26.135.
section).
Appendix A Subpart B 2.4(i)............ 26.117.
Appendix A Subpart B 2.4(j) (first two 26.115 and 26.185.
sentences).
[[Page 50677]]
Appendix A Subpart B 2.4(j) (final Deleted.
sentence).
Appendix A Subpart B 2.5(a)............ 26.155(a).
Appendix A Subpart B 2.5(b)............ 26.153.
Appendix A Subpart B 2.5(c)............ 26.155(c).
Appendix A Subpart B 2.5(d)............ 26.155(d).
Appendix A Subpart B 2.5(e)............ 26.155(e).
Appendix A Subpart B 2.5(f)............ 26.155(f).
Appendix A Subpart B 2.6(a)............ 26.125(a).
Appendix A Subpart B 2.6(b)............ 26.125(b).
Appendix A Subpart B 2.6(c)............ 26.125(c).
Appendix A Subpart B 2.7(a)............ 26.127, 26.129, 26.157, and
26.159.
Appendix A Subpart B 2.7(b)............ 26.129(b) and 26.159(b).
Appendix A Subpart B 2.7(c)............ 26.129(f) and 26.159(h).
Appendix A Subpart B 2.7(d)............ 26.157 and 26.159.
Appendix A Subpart B 2.7(e)............ Validity screening and initial
validity test requirements in
26.131 and 26.161 and initial
cutoff levels in 26.133 and
26.163(a).
Appendix A Subpart B 2.7(f)............ 26.163(b).
Appendix A Subpart B 2.7(g)(1) through 26.169.
(5).
Appendix A Subpart B 2.7(g)(6) and (7). Requirement for annual summary
in 26.169(k).
Appendix A Subpart B 2.7(g)(8)......... 26.215.
Appendix A Subpart B 2.7(h)............ 26.159(i) and by 26.135(c).
Appendix A Subpart B 2.7(i)............ Subparts F and G.
Appendix A Subpart B 2.7(j)............ 26.113, 26.135, 26.165.
Appendix A Subpart B 2.7(k)............ 26.153(c).
Appendix A Subpart B 2.7(l)............ 26.153((f)(1) and 26.153(b).
Appendix A Subpart B 2.7(m)............ 26.87(c) and 26.221.
Appendix A Subpart B 2.7(n)............ 26.215(a).
Appendix A Subpart B 2.7(o)(1)......... 26.127(c) and 26.157(c).
Appendix A Subpart B 2.7(o)(2), (o)(3), 26.137 and 26.167.
and (o)(4).
Appendix A Subpart B 2.7(o)(5)......... 26.139(c) and 26.153(f)(2).
Appendix A Subpart B 2.8(a)............ 26.137(a) and 26.167(a).
Appendix A Subpart B 2.8(b)............ 26.137.
Appendix A Subpart B 2.8(c)............ 26.167.
Appendix A Subpart B 2.8(d)............ 26.137 and 26.167.
Appendix A Subpart B 2.8(e)(1) to 26.137.
(e)(3).
Appendix A Subpart B 2.8(e)(4), (e)(5), 26.137 and 26.219.
and (e)(6).
Appendix A Subpart B 2.9(a) and (b) 26.183.
(through ``contract employee'').
Appendix A Subpart B 2.9(b) (balance of 26.185.
section), (c), (d), (e), (f), and (g).
Appendix A Subpart C 3.1............... 26.37(e) and 26.153(f)(3).
Appendix A Subpart C 3.2............... 26.75(i)(4), 26.165(f).
Appendix A Subpart D 4.1............... 26.153.
------------------------------------------------------------------------
[FR Doc. 05-15576 Filed 8-25-05; 8:45 am]
BILLING CODE 7590-01-P