[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Proposed Rules]
[Pages 21105-21146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11046]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed
Rules
[[Page 21105]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 26
RIN 3150-AF12
Modifications to Fitness-For-Duty Program Requirements
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) proposes to amend its
regulations to modify the current Fitness-For-Duty Program (FFD)
requirements. The proposed amendments would apply to all licensees
authorized to construct or operate a nuclear power reactor and all
licensees authorized to possess or transport Category I nuclear
material. The proposed rule is intended to ensure compatibility with
changes made to the Department of Health and Human (HHS) testing
guidelines, reduce unnecessary burdens, and ensure continued protection
of public health and safety.
The NRC specifically requests comments on a number of issues and,
in particular, as to whether the changes would provide a substantial
increase in the overall protection of the public health and safety and
the common defense and security, whether the rule as whole does not
constitute a backfit since the rule's cumulative effect is to ease
licensee burdens or leave them essentially the same, whether those
subject to the rule would not object to the new requirements in view of
their perception of overall benefit and, if so, whether their non-
objection could be grounds for not applying the backfit rule.
DATES: The comment period expires August 7, 1996. Comments received
after this date will be considered if it is practical to do so, but the
Commission is able to assure consideration only for comments received
on or before this date.
ADDRESSES: Mail comments to: The Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, ATTN: Docketing
and Service Branch.
Deliver comments to: One White Flint North, 11555 Rockville Pike,
Rockville, Maryland between 7:30 am and 4:15 pm on Federal workdays.
Copies of the draft regulatory analysis, comments received, the
Americans With Disabilities Act Technical Assistance Manual, HHS's
Medical Review Officer Manual, and NIDA's Technical Advisory of March
11, 1991, may be examined at: the NRC Public Document Room, 2120 L
Street, NW. (Lower Level), Washington, DC.
Copies of NUREG/CR-5784, ``Fitness for Duty in the Nuclear Power
Industry: A Review of the First Year of Program Performance and an
Update of the Technical Issues,'' NUREG-1385, ``Fitness for Duty in the
Nuclear Power Industry: Responses to Implementation Questions,'' and
NUREG/CR-5758, ``Fitness for Duty in the Nuclear Power Industry: Annual
Summary of Program Performance Reports,'' CY 1994, Volume 5, may be
purchased from the Superintendent of Documents, U.S. Government
Printing Office, P.O. Box 37082, Washington, DC 20402-9328. Copies are
also available from the National Technical Information Service, 5282
Port Royal Road, Springfield, VA 22161. A copy is available for
inspection and/or copying in the NRC Public Document Room, 2120 L
Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Loren L. Bush, Jr., Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555. Telephone: (301) 415-2944.
SUPPLEMENTARY INFORMATION:
Background
The NRC is proposing to amend its regulations on ``Fitness-for-Duty
Programs,'' as part of its ongoing activities to improve its
regulations.
The objective of the licensee's fitness-for-duty program is to
provide reasonable assurance that nuclear power plant personnel are
reliable, trustworthy, and 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. Fitness-for-duty programs developed
under the requirements of 10 CFR Part 26 are intended to create an
environment which is free of drugs and the effects of such substances.
In its deliberation of the many issues associated with the
rulemaking, the Commission desired that the rule ensure a proper
balance between safeguarding individual rights and the Commission's
responsibility to protect public health and safety. The changes
proposed in this rulemaking are intended to be consistent with the
Commission's original goals and to ensure there is a proper balance
between the Commission's responsibility for protecting the public
health and safety and its interest in protecting individual employee
rights from unconstitutional invasion of their right to privacy.
The NRC has reviewed the experience gained since publication of the
rule on June 7, 1989 (54 FR 24468), which was implemented by licensees
January 3, 1990. NRC review included information from several sources,
such as inspections, periodic reports by licensees on program
performance, reports of significant FFD events, industry-sponsored
meetings, initiatives by the Nuclear Management and Resources Council
(NUMARC) (now the Nuclear Energy Institute) and the Substance Abuse and
Mental Health Services Administration (SAMHSA) (formerly the National
Institute on Drug Abuse [NIDA]) and its Drug Testing Advisory Board,
and current literature. The review indicates that, although the rule is
fundamentally sound and provides a means for deterrence and detection
of substance abuse, some matters need to be addressed. These matters
include the--
(1) Need to ensure compatibility with changes made to the HHS
guidelines;
(2) Reduction of burden on licensees while fulfilling the purpose
of the rule;
(3) Need for a limited number of new requirements, e.g., to further
reduce the potential for subversion of the testing process and to make
clear that the appeal process applies to all persons covered by the
rule; and
(4) Need to clarify the Commission's original intent in several
areas to reduce incorrect or inconsistent use and differing
interpretations and to make a number of administrative changes.
While none of the proposed amendments represent major changes,
[[Page 21106]]
they do represent modifications that would substantially reduce the
cost of implementation to licensees; enhance overall program integrity,
effectiveness, and efficiency; and help to ensure the continued
protection of public health and safety.
Discussion
The proposed amendments take into account the experience gained in
implementing the initial rule, developments in the FFD area, and
actions by other Government agencies on drug testing and other FFD
concerns. During implementation of new regulations, particularly
regulations in rapidly evolving disciplines such as drug testing and
employee reliability, a substantial number of lessons are learned from
experience. The first five years of experience with the NRC's fitness-
for-duty rule are no exception. A significant number of the proposed
revisions are adjustments to the rule that would decrease the burden on
licensees without reducing the protection of public health and safety
afforded by the rule. For example, one proposed revision would allow
licensees to grant unescorted access to personnel covered by another
licensee's FFD program. This would facilitate interchange of employees
in, for example, ``peer evaluator'' situations. Another proposed
revision of this type would permit licensees to accept generic portions
of training provided by another licensee to people covered by the rule.
This revision would recognize that significant portions of all
licensees' fitness-for-duty training cover the same general subjects
and would facilitate more timely contractor support during outages.
While some proposed revisions would increase program efficiency,
others would ensure that the Commission's FFD program more effectively
achieves its objectives. For example, the Commission is proposing
several revisions to the rule's drug and alcohol testing requirements
that would clarify testing processes and purposes. While many of these
rule changes would strengthen testing requirements, others would reduce
the testing burden on licensee and contractor employees. These and
other revisions would bolster the rule's protection of public safety
while reducing the industry's regulatory burden where possible.
The NRC is also proposing a substantial number of revisions to
respond to legal and regulatory changes that have occurred since the
publication of 10 CFR Part 26. For example, the Department of
Transportation (DOT) and its operating administrations (e.g., the
Federal Aviation Administration (FAA), the Federal Railroad
Administration (FRA), and the Federal Highway Administration (FHA)) and
other Federal and State agencies have expanded their drug and alcohol
testing requirements during the past five years. Some of these
regulatory changes have created requirements applicable to some
licensee employees and contractors that duplicate the NRC's drug and
alcohol testing requirements. To reduce unnecessarily duplicative
burdens, the Commission is proposing to permit testing performed under
these other programs to be accepted in lieu of 10 CFR Part 26 testing
when individuals covered by an NRC program are also subject to another
program. Another change since the publication of 10 CFR Part 26 has
been the implementation of the requirements of the Americans with
Disabilities Act (ADA). While the ADA specifically exempts the NRC's
program from certain requirements, various proposed revisions to the
regulation accommodate certain aspects of the Act. For example, the
current rule requires licensees to determine whether unescorted access
to protected areas and other activities specified in 10 CFR 26.2 have
ever been denied to people seeking unescorted access because of
substance abuse and related activities. This section would be revised
to limit such inquiry to events that may have occurred during only the
previous five years.
During the first years of FFD rule implementation a number of
requirements have been found to be ambiguous and therefore subject to
inconsistent application by licensees. These ambiguities have been
costly to licensees and NRC staff as they have required a substantial
number of discussions involving licensee FFD staff, attorneys, and
consultants; NRC inspectors; and NRC headquarters staff. Although these
ambiguities have already been clarified for many licensee programs, the
NRC is proposing revisions that would clarify the Commission's intent
and help ensure that the regulation is consistently implemented,
inspected, and enforced throughout the industry. Increased consistency
of rule application throughout the industry will benefit licensees and
their employees by reducing the chances of arbitrary or discriminatory
application of the rule.
Finally, there are a number of proposed revisions that would
improve the clarity of the rule. For example, several terms regarding
the testing process and testing results have been more carefully
defined and consistently used to eliminate difficulties in
interpretation.
In considering the actions to be taken, the NRC will continue to
consider the proper balance between safeguarding an individual's rights
and protecting public health and safety.
In proposing these FFD rule revisions, the NRC also notes that it
is continuing to move toward a performance-based regulatory approach in
most of its rule making. Performance-based regulations are intended to
give regulated entities clear guidance as to the objective of those
regulations but not to be overly prescriptive in mandating specific
means by which those entities must achieve the objectives. In taking
this approach, the Commission expects to promote efficiencies in
nuclear facility operations while maintaining the highest standards of
public health and safety. Both NRC policy and Congressional directives
emphasize the need for the Commission to move toward performance-based
regulation.
While some of the proposed FFD rule revisions reflect this
performance-based philosophy--most notably the increased licensee
discretion incorporated into Sec. 26.80 auditing requirements--the
somewhat prescriptive nature of the current 10 CFR Part 26
(particularly of Appendix A), and many of the proposed revisions, are a
partial departure from that regulatory approach. The NRC believes that
several characteristics of and issues associated with fitness-for-duty
programs make it necessary for the Commission to continue to provide
detailed directives in this particular context. A relatively more
specific regulatory approach, for example, will continue to assure that
state and local restrictions will not hinder the stringent drug and
alcohol testing needed to assure that personnel covered by the rule
will continue to safely and competently perform their duties. If the
NRC's requirements are not clearly stated in the rule, some state and
local laws would prohibit licensees from implementing key program
elements, thus making complete achievement of the rule's performance
objectives difficult or impossible. The NRC believes that it must
maintain the specificity of this rule in order to clearly preempt such
state and local laws that could otherwise apply to licensees' fitness-
for-duty programs.
The rule's specificity also protects the rights of personnel
subject to the rule's mandates. Many of the rule's detailed
requirements address the need to assure that testing is performed in a
highly reliable manner and that workers are not wrongly accused due to
false positive test results. Many of these details address these
concerns and have served to provide high confidence that false
[[Page 21107]]
positives will not be obtained. While protecting workers against
unwarranted damage to their careers in this way, these detailed
requirements provide quality controls that also assure accurate, valid,
and dependable test results. This, in turn, bolsters FFD program
credibility and acceptance among workers. The specific provisions in
the rule have assured workers who do not abuse drugs or alcohol that
FFD program requirements are administered fairly and competently and
that their fellow workers who do violate FFD policy will likely be
detected and removed from duty.
The rule's specificity has also benefited licensees during the
first five years of the rule's implementation. This specificity has,
for example, helped assure that positive test results can be more
easily defended when challenged in court and during unemployment
proceedings. They have also provided a clear statement of the NRC's
position for licensees and labor representatives to use when
negotiating FFD-related issues in collective bargaining agreements. The
introduction of drug testing and related fitness-for-duty program
requirements into the workplace is a mandatory issue for collective
bargaining under the National Labor Relations Act. A prescriptive
fitness-for-duty rule enables licensees and labor representatives to
more effectively achieve the NRC's program objectives by clearly
showing that the NRC requires particular program elements to be
implemented in specific ways.
Like the NRC, other Federal and state agencies have also found it
necessary to establish specific requirements rather than adopt a more
performance-based approach to assuring worker fitness. For example, the
detailed nature of the NRC's FFD rule is matched by the drug use and
alcohol abuse prevention rules promulgated by the DOT and its five
operating administrations. The level of detail of the HHS requirements
for the testing of Federal workers is also comparable to that provided
by Part 26. The experience of these agencies bears out the need for
relatively specific regulations in this workplace fitness context.
The NRC seeks public comment on the following issues. Public
comments should be submitted to the NRC as indicated under the heading
Addresses.
1. Would any of the proposed changes, group of related requirements
(e.g., modifications to prevent subversion of the testing process,
further ensure the accuracy and integrity of testing, clarify actions
for removal), or the rulemaking as a whole provide a substantial
increase in the overall protection of the public health and safety or
the common defense and security? Are the groupings and subgroupings of
the changes contained in the Backfit Analysis section of this Federal
Register notice appropriate and are the changes categorized properly?
Are the changes in Group III worthwhile and necessary to better
accomplish the FFD rule's objective, clarify the rule's existing
requirements, and reduce ambiguities. Does the rule as a whole not
constitute a backfit since the rule's cumulative effect is to ease
licensee burdens or leave them essentially the same, rather than to
increase them. Does anyone subject to the rule not object to the new
requirements in view of their perception of an overall benefit and, if
so, would their non-objection be grounds for not applying the backfit
rule? Although the NRC believes that the proposed specific changes to
the fitness-for-duty rule (FFD) would be the most efficient method of
accomplishing the regulatory objectives of the changes, are there any
viable alternative approaches that should be considered, particularly
with respect to the proposed changes in Group III B? Could the rule be
less specific in stating the requirements? The staff's analysis of
alternative approaches such as development of a Regulatory Guide, NUREG
good practices, meetings with licensees, or industry initiatives, is
contained in the draft Regulatory Analysis.
2. Should the NRC revise Appendix A to 10 CFR Part 26 to
incorporate revisions to the Mandatory Guidelines for Federal Workplace
Drug Testing Programs recently adopted by the Department of Health and
Human Services (HHS) (June 9, 1994; 59 FR 29908)? The Commission
proposes adoption of the changes to the HHS guidelines. In most
instances, the HHS guidelines have been adopted as published by HHS;
however, in some cases modifications are proposed to allow
compatibility within the framework of the original FFD rule (e.g., on-
site testing provisions dictated differences in minimum specimen
volume, minimum number of blind performance specimens, on-site
determination of the validity of specimens). The NRC desires to be
consistent with the HHS Guidelines, absent a compelling reason why a
departure is necessary.
3. With respect to the discussion of the proposed changes to
Sec. 26.24, are there any alternative techniques for testing for
alcohol that should be considered for adoption by the NRC?
4. During the past five years of program operations, several
parties have recommended that the NRC consider obtaining certain types
of information in addition to that currently required to be submitted
under the provisions of Sec. 26.71(d). They believe that the Commission
could use such information to better manage its FFD program oversight
responsibilities, which includes formulation of public policy. The
specific additional types of information and their potential use by the
NRC are described in the discussion of proposed revisions to Sec. 26.71
but are not incorporated into the proposed changes to the text of the
rule. The NRC requests public comment on whether the licensees should
be required to collect, analyze, and submit to the NRC such additional
types of information.
5. The NRC is proposing to add a new Section 2.7(e) to Appendix A
that would require testing to determine specimen validity (i.e., detect
evidence of adulteration or dilution) before performing a screening
test on site (if appropriate) and at the HHS laboratory. This would be
an adaptation of a change HHS made to its guidelines in June, 1994.
However, not all dilute specimens are the result of attempts to avoid
detection. Hence, to minimize the probability of incorrect conclusions
from such events, suspect specimens, including those with abnormal
specific gravity (SG) would be subject to screening and confirmation
testing using the limit of detection that the laboratory is capable of
performing. The Commission requests comments regarding this change,
and, in addition, requests comments on three other revisions to detect
evidence of adulteration or dilution that are under consideration:
a. Including Ph and/or creatinine as well as SG in the required
testing to determine specimen validity;
b. Requiring tests to determine specimen validity (which might
include SG, Ph, and/or creatinine) immediately after specimen
collection at all sites and immediate collection of a second specimen
from those individuals providing specimens with abnormal qualities; and
c. Requiring tests at one-half of the cut-off levels specified for
each drug instead of at the HHS-certified laboratory's limit of
detection for suspect specimens.
6. With respect to the discussion of the proposed changes to
Section 2.7 of Appendix A:
a. Should the NRC require tests for agents that can be added to
urine as an attempt to mask THC (marijuana) or other drugs?
b. Should the NRC raise the cutoff levels for screening and
confirmation
[[Page 21108]]
tests for opiates to reduce the laboratory-confirmed positives for
opiates that the medical review officer (MRO) determines to be
negative? Given the high level of concern for safety in the nuclear
industry, should the NRC retain the current levels, even if HHS should
raise the levels for ``demand reduction'' programs covered by its
Guidelines as it proposed on November 16, 1995 (60 FR 57587).
7. A key element of assuring the integrity of the testing program
is the continued assurance of test accuracy through licensees'
submission of blind performance test specimens to HHS-certified
laboratories as required by Section 2.8(e) of Appendix A. The NRC has
received a number of suggestions regarding improving these blind
performance test specimen requirements. The Commission is considering
each of these suggested revisions and invites public comment on the
following:
a. A limited HHS survey of blind performance test specimens
supplied by various vendors has indicated a wide range of drug or
metabolite concentrations in spiked specimens. Should the NRC require
licensees to assure that concentration ranges for blind performance
test specimens be within a defined range (to be determined in
consultation with HHS)?
b. Should the NRC require that providers of performance test
specimens be separate and independent (no conflict of interest) from
those performing the specimen collection, specimen testing, MRO, and
auditing functions?
8. The NRC has received requests from several licensees and vendors
to permit the on-site use of non-instrumented, qualitative immunoassay
methods that involve the use of inexpensive, disposable devices. As
discussed in more detail under the proposed changes to Section 2.7 of
Appendix A, these screening techniques have not been validated to
achieve the high levels of specificity and accuracy that are needed in
FFD programs. Of concern to the Commission is that these devices may
produce an unacceptably high number of false negative test results and
may be easily subverted. The Commission invites public comment on the
advisability of creating guidelines, quality assurance procedures, and
performance standards to govern use of these devices. Alternatively,
should the Commission prohibit the use of these devices until such time
as HHS (or another agency) has developed guidelines, procedures, and
standards. Should there be a Conforming Products List for these devices
similar to that published by the National Highway Traffic Safety
Administration (NHTSA) for evidential breath measurement devices? Who
should administer such a program?
Groups of Interrelated Revisions
Several of the proposed rule changes should be considered as groups
of interrelated revisions that, if adopted, will interact with each
other and with the current rule to accomplish important FFD objectives.
Foremost among these are several revisions intended to minimize
subversion of the testing process. Subversion has proven to be a
continuing problem that threatens the effectiveness of workplace
testing programs across the country. Although a number of techniques
for subverting the testing process exist, flushing (diluting the
specimen by drinking copious amounts of water) appears to be the most
common. The proposed rule is intended to reduce the potential for
successful subversion by flushing include (1) a requirement that
licensees minimize the time between notification of the person to
report for a random test and the collection of the specimen and (2) a
requirement to determine the validity of specimens, which would be done
through testing for specific gravity (SG) and may include several other
methods. Other forms of subversion include the adulteration of
specimens and the submission of surrogate specimens. Reducing the time
between notification and testing will also counter these subversion
techniques. To further reduce the potential for subversion, the NRC
proposes using a narrower temperature range than set by the HHS
guidelines for determining an acceptable specimen. This would make it
more difficult to submit surrogate specimens and to use some dilution
techniques. The proposed rule also would revise various sections to
state more clearly that any act or attempted act of subversion is to be
considered a violation of FFD policy. These revisions would provide an
integrated response to the problem of subversion.
The Commission also is proposing to require that dilute and other
questionable specimens be tested at the lowest level of detection (LOD)
that the laboratory is qualified to use. While this revision would have
an anti-subversion effect, its primary purpose would be to further
protect those being tested. Currently, when a testing laboratory
determines that a specimen is dilute or otherwise of questionable
quality, the person tested is required to produce a second specimen
under the direct observation of a collection site person. Test results
indicate, however, that a great majority of dilute specimens result
from reasons other than drug use. Requiring level-of-detection testing
would infringe less on the individual's privacy by minimizing the need
to produce a second specimen under direct observation. It would protect
those being tested also by providing MROs with additional useful
information to enable them to make accurate determinations of whether a
specimen of questionable validity has actually been adulterated or
diluted.
The proposed revisions pertaining to removal from unescorted access
because of FFD policy violation and subsequent return to work
constitute a second important group of interrelated revisions. One
revision would clarify the Commission's original intent that any
violation of a licensee's FFD policy must result in immediate removal
from unescorted access status upon determination of a violation. Before
a person is allowed to return to work, the condition that led to
removal would have to be resolved through a medical determination of
fitness conducted by appropriately qualified personnel and the person
would have to be tested under a proposed return-to-duty testing
requirement. Another related revision would clarify the Commission's
intent that persons to whom unescorted access is reinstated after a
policy violation are to be subject to follow-up testing for a three-
year period. These and other proposed changes are intended to provide a
more complete set of requirements relating to removals and return to
duty.
The NRC is also proposing a set of revisions that would address
situations in which individuals subject to the rule's testing
requirements are only infrequently on site. Although most licensees
have appropriate provisions in this area, several licensees have gone
to great expense in bringing off-site workers to the collection
facility for testing immediately upon their being chosen from the
random testing pool. Some off-site workers have been required to drive
2-4 hours each way, fly cross country, and/or stay overnight. Some
licensees use mobile collection facilities or teams to travel to the
location of the person selected for testing. One proposed revision
would make clear the NRC's original intent that people need not be
immediately brought to the site for testing in such situations. Another
related revision would eliminate the requirement for a suitable inquiry
into a person's employment status when the person returns to a site
after having not been covered by an FFD program for thirty days or
less. This
[[Page 21109]]
revision would also clarify the requirements applicable to individuals
who come to the site only infrequently.
A fourth group of revisions relates to testing for alcohol.
Impairment caused by alcohol misuse creates a safety risk that is
fundamentally similar to the risk posed by the misuse of illegal drugs.
Some licensees, however, have imposed lesser sanctions for alcohol
violations, an approach that is contrary to the Commission's intent.
The NRC proposes to rectify this situation by explicitly requiring the
same minimum sanctions for abuse of alcohol as currently exist for use
of illegal drugs. Several proposed revisions would contribute to this
objective. One revision would explicitly define the FFD policy
violations involving alcohol. Likewise, alcohol test results between
0.02 and 0.04 percent would be forwarded to the Medical Review Officer
(MRO) for back calculation to determine whether the person had an
impermissibly high blood alcohol content while on duty. The
requirements concerning conduct of suitable inquiries would also be
revised to explicitly require that licensees determine whether persons
seeking unescorted access status have ever used alcohol in a manner
that resulted in on-duty impairment.
A fifth group of proposed revisions would address current
ambiguities associated with the testing for the use of amphetamines.
The standard for confirmatory testing for methamphetamines would be
supplemented with the requirement that specimens must also contain a
specific amount of amphetamine to be confirmed as positive. Multiple
screening tests would be permitted to reduce the amphetamine testing
problems caused by cross reactivity. A requirement that specimens
confirmed positive for amphetamines must also be tested for d and l
isomers is another related proposed revision. Another proposed revision
would allow an extra two days for HHS-certified laboratories to report
to licensees test results having suspected amphetamines. These
revisions would serve to clarify and rationalize testing requirements
for amphetamines.
Use of Old Test Results
The NRC also cautions licensees that test results obtained before
January 3, 1990, should be considered with great care. The results may
be questionable for the following reasons:
The HHS laboratory certification program was initiated in
1988 and by the end of 1989 about 40 laboratories were certified. Many
of the laboratories being used did not meet current performance
standards for accuracy and reliability.
In some cases, confirmation tests may not have been
conducted.
In many cases, there was no review by a technically
qualified person, such as a MRO, to determine if legitimate uses of
drugs (particularly amphetamines and opiates) were causing the results
reported by the laboratories.
The NRC staff has been informed of several cases in which persons
alleged they had a record of a questionably positive drug test 5 to 15
years ago, have since worked in the nuclear industry with a good work
record and no positive drug tests, and are now denied employment. The
Commission recognizes that positive drug test results obtained before
the rule was implemented may indicate persons who have a significant
past history of drug abuse but, because of the factors noted above,
other available information should also be considered.
Description of Proposed Changes by Section
The following discussion describes the changes to the current FFD
rule that are being proposed and the reasons for the changes.
Section 26.2 Scope
The NRC proposes to amend this section to include specified classes
of personnel who administer testing programs. Although Section 2.3 of
Appendix A requires that licensees carefully select and monitor persons
responsible for administering the testing program based upon the
highest standards of honesty and integrity, some licensees' testing
programs have not included all persons originally intended to be
tested. This action is taken to clarify the Commission's original
intent because although these people normally work outside the
protected area, their actions do have an ongoing effect on safety and
would have an impact on the confidence of management and the workforce
in the integrity of the program and the reliability of the results.
Persons who administer testing programs are in a position to permit
substance abusers to remain undetected. The persons who administer the
tests could inadvertently omit testing of an employee as a result of
impaired behavior on the part of the test administrator because of
substance abuse or intentionally because of motives associated with
substance abuse, empathy with the abuser, etc. Furthermore, the
omission of test administrators from testing and other program
requirements tends to undermine the credibility of licensees' FFD
programs.
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
collection personnel to the testing pool after investigation of an
allegation determined that two specimen collectors were substance
abusers. In another instance, a contracted MRO not in the testing pool
was reported to be an alcoholic and an abuser of prescription drugs.
The proposed revision to Sec. 26.2(a) would fulfill the NRC's
original objective for this section and require all licensees to extend
the coverage of their programs to the following three classes of FFD
personnel:
Personnel who can link test results with the person who
was tested;
Personnel making removal and return-to-work
recommendations or decisions; and
Personnel involved in the selection and notification of
employees for testing and the collection of specimens.
Specimen collectors, the MRO, the FFD program manager, Employee
Assistance Program (EAP) counselors, and other selected administrative
staff would be examples of FFD program personnel who would be included
within this clarification of the rule's scope. Testing of FFD personnel
is further discussed in conjunction with Section 2.3 of Appendix A.
The NRC also proposes to amend Sec. 26.2 to allow reduced scope
programs for facilities that are in the process of being
decommissioned. Because the level of risk associated with these
facilities will decline during decommissioning, the revision is
designed to provide the NRC with the flexibility to tailor the FFD
program to site-specific factors as deemed appropriate by the NRC to
protect public health and safety.
Finally, the NRC proposes to amend Sec. 26.2 to provide that people
covered by a program regulated by another Federal or state agency that
meets the general performance objectives of the FFD rule need not be
additionally covered by a licensee'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 Department of Transportation's drug testing requirements
and new alcohol testing rule have been implemented. Differences in
specific program requirements, such as the use of different cut-off
levels (but which are at
[[Page 21110]]
least as stringent as the HHS guidelines), would be unlikely to have a
significant effect on the licensee's FFD program in meeting the general
performance objectives. The licensee would continue to be responsible
for behavioral observation, immediate removal from duty of persons
whose fitness may be questionable, and for-cause testing for a specific
situation. This revision would reduce the burden on individuals covered
by multiple Federal and State programs with requirements that duplicate
the FFD rule.
Section 26.3 Definition
The NRC proposes that this section be modified to clarify
definitions of some terms, to make terms and definitions more
consistent with those used by other Federal agencies (including the
Substance Abuse and Mental Health Services Administration and the
Department of Transportation), to provide new definitions to support
other sections of the rule, and to remove three terms, ``random test,''
``follow-up testing,'' and ``suitable inquiry,'' because they are
already fully defined in the text of the rule. In addition, several
terms have been moved to this section from Section 1.2 of Appendix A
because they first appear in the main body of the rule.
For the most part, changes in this section are intended to
eliminate differing interpretations and ambiguities in current wording.
The Commission proposes three changes to the terms used for definitions
of drug test results. The changes include modification to the
definition of ``confirmed positive test'' to reflect proposed changes
to terms and definitions, and the addition of the terms ``laboratory
confirmed positive'' and ``unconfirmed positive test result.''
``Laboratory confirmed positive'' would refer to the positive outcome
of a gas chromatography/mass spectrometry (GC/MS) test. These tests are
reviewed by the MRO to determine if they show a violation of the FFD
policy or if there is a medical explanation for the positive result.
``Unconfirmed positive test result'' would refer to the result of a
screening test that is not negative. The original wording of the rule
refers to these results in a number of ways, most often as
``presumptive positives.'' The term ``presumptive positive'' and other
terms used to refer to this result have been replaced with
``unconfirmed positive test result'' throughout the rule to increase
clarity and consistency. The definition of ``confirmatory test'' would
be revised to reflect a proposed revision made elsewhere in the rule
relating to blood tests for alcohol that could be used in an appeal.
The term ``screening test'' would replace the former terms ``initial or
screening test'' in the interests of clarity.
The NRC proposes to add a definition of ``medical determination of
fitness'' to support proposed changes to other sections of the
regulation. This term would clarify the role of the MRO or other
licensed physician in determining fitness for duty and provide a
standard regarding what constitutes this determination. The focus of
the medical determination would be to determine if a rule or policy
violation has occurred and to evaluate the potential for on-duty
impairment (e.g., of sensory, cognitive, motor and communicative
skills) that would interfere with the safe performance of the
individual's duties.
A new definition of ``behavioral observation'' is proposed that
would clarify the role of supervisors in monitoring the behavior of
workers under their oversight. It is the NRC's intent that all
personnel having unescorted access to the protected area be subject to
behavioral observation. To accomplish this goal, supervisors are
expected to observe the behavior of all personnel with whom they have
routine contact, not only those workers for whom they have direct
supervisory responsibility. Licensees would, for example, be
responsible for ensuring that contractor employees whose supervisors
may remain off site be subject to behavioral oversight by licensee
supervisory personnel when within the protected area. The contractor
employees would, however, still be subject to behavioral observation by
their own supervisors when off site. A definition for ``supervisor'' is
proposed to clarify that supervisors include all personnel with
supervisory responsibilities over workers with unescorted access,
whether they are on site or off site.
The NRC proposes to add the terms ``abuse of legal drugs'' and
``substance abuse'' and definitions for these terms to clarify the
intent of the rule and to support changes to management actions and
sanctions regarding alcohol and other legal drugs and substance abuse.
The NRC proposes to add the term ``subversion'' and to define it in
terms of the intentional causing of a missing or inaccurate drug or
alcohol test result at any stage of the testing program, including the
process of selection and notification, specimen collection, specimen
analysis, testing, and reporting of test results.
Finally, the NRC proposes that the definition of ``aliquot'' be
modified by adding language designed to make it clearer that the
aliquot is a representative sample of a specimen and can be used for
retesting.
Section 26.7 Communications
A new section, ``Communications,'' similar to existing sections in
other 10 CFR Parts would be added to ensure that communications with
the NRC are processed properly.
Section 26.8 Information Collection Requirements: OMB Approval
The NRC proposes to delete Sec. 26.8(c) which presents an estimate
of the total time burden for this Part's recordkeeping requirements and
solicits licensee comments concerning the accuracy of the estimate and
ways by which the burden can be reduced. This information is not
normally codified in the regulations and is being deleted to maintain
consistency with other parts throughout 10 CFR Chapter I. Burden
estimates and requests for public comments on the burden estimates
continue to be published in the preamble of Federal Register Notices
for NRC rulemaking in accordance with Office of Management and Budget
(OMB) regulations.
Section 26.20 Written Policy and Procedures
The NRC proposes several changes to this section. One amendment
would make it clear that licensees' overall description of their policy
on FFD must be prepared in a summary form, which most licensees have
done, and made readily available to employees covered by the rule
[Sec. 26.20(a)]. It has been noted during inspections that a few
licensees had incorporated their FFD policy into the several procedures
that were not readily available to employees. The NRC's intent remains
that licensees publish a statement notifying employees of the policy as
is required by the Drug-Free Workplace Act of 1988.
Other amendments would clarify Sec. 26.20 (a) and (d) to ensure
that a licensee's FFD policy addresses employees' off-site involvement
with illegal drugs, the abuse of legal drugs, the subversion of the
testing process by adulterating or substituting specimens, the refusal
to provide a specimen, and use of prescription and over-the-counter
medications that may cause impairment. This revision would make
explicit the need to address FFD concerns that have emerged during the
first five years of program operation.
Another amendment would clarify the requirements pertaining to
licensees' procedures to ensure that persons called in to perform an
unscheduled working tour are fit to perform the task assigned
[Sec. 26.20(e)]. This section currently
[[Page 21111]]
requires called-in employees to state whether they have consumed
alcohol within the licensee's pre-duty abstinence period. The proposed
revision would make it clear that this declaration of fitness includes
fitness to perform tasks assigned, not just alcohol consumption. These
revisions would afford employees an added safeguard in that they would
have an opportunity to express their own opinion as to whether they
believe themselves fit in view of fatigue, illness, use of medication
or consumption of alcohol to perform assigned tasks. This requirement
would also enable licensees to obtain the information over the
telephone to avoid having to get that person safely home after arriving
onsite unfit to work, call in another person, and avoid the potential
for civil lawsuits that could arise from accidents while the called-in
person is in travel.
Another amendment would remove the statement that the Commission
may review the licensee's FFD policy and procedures at any time
[Sec. 26.20(f)]. This provision is unnecessary because the Commission
may always inspect the licensee's program.
A new Sec. 26.20(f) would add a paragraph that would allow
licensees to credit unescorted access status granted by other
licensees. Such individuals must be covered by the random testing and
behavioral observation programs of either the original licensee
employer or that of the host licensee. This change would facilitate the
interchange of personnel among licensees in, for example, situations
where a ``peer evaluator'' from one licensee works with a second
licensee (e.g., inspections conducted under the auspices of the
Institute of Nuclear Power Operations (INPO)). It clarifies that there
is no need for a licensee to audit another licensee's program before
granting unescorted access to that licensee's employee.
The NRC continues to believe that an abstinence period of at least
5 hours preceding any scheduled working tour is appropriate and wishes
to clarify the implications of this abstention period for employees.
This requirement continues to accommodate a reasonable and moderate
amount of off-duty alcohol consumption outside the abstention period.
Employees do need to be aware, however, that immoderate alcohol
consumption, even if it occurs before the start of the abstinence
period, can later result in an FFD policy violation. If, for example,
an employee were to consume a relatively large volume of alcohol six
hours before starting work and, in the interim, consume a heavy meal
(the consumption of food can significantly slow the metabolism of
alcohol), the employee could be at risk of violating FFD policy (i.e.,
could have a blood alcohol content (BAC) of 0.04 percent or higher when
reporting for work). Therefore, it is incumbent upon employees to
exercise restraint in their alcohol consumption even outside of the 5-
hour abstention period. Although moderate off-duty drinking is not
prohibited by FFD policy, employees should understand heavy alcohol
consumption can be an FFD concern even though it occurs before the
abstinence period. The NRC is aware that some past alcohol-related
violations of licensees' FFD policies have resulted from employees'
lack of understanding of these issues. Communication of these matters
to employees is particularly important because the proposed rule would
make management sanctions mandatory for alcohol-related FFD policy
violations.
Section 26.21 Policy Communications and Awareness Training
The NRC proposes to decrease the frequency of FFD policy and
awareness refresher training from every 12 to every 24 months. However,
the Commission expects that FFD program changes, such as would be
mandated by final rulemaking, would be communicated to all affected
workers before the changes are implemented. The material presented in
this training is relatively straightforward and is not expected to
change significantly over time. Refresher training on a nominal 24-
month frequency would be sufficient to keep personnel covered by the
rule aware of FFD program policy and procedures. Another proposed
amendment to this section would allow licensees to accept the generic
portions of training of individuals who have been subject to a Part 26
program at another site and have received initial or refresher training
within the past 24 months; site-specific training would continue to be
required before unescorted access may be granted. Policy communications
and awareness training covers a number of common areas that are
consistent across licensee programs. Because there are some differences
among licensees, new personnel should be trained in those aspects of
licensee programs that are particular to the site.
Section 26.22 Training of Supervisors and Escorts
The NRC proposes to amend the provision pertaining to the initial
and refresher FFD training of supervisors and escorts. One amendment
would clarify the NRC's intent that, except in the case of people
receiving their initial supervisorial assignment, all supervisors of
licensee employees and contractor personnel and all escorts must fully
complete their initial FFD supervisory training before assignment to
duties within the scope of Part 26. Supervisors of licensee employees
receiving their initial assignment would be required to complete
training as soon as feasible but would continue to have up to three
months to complete initial training. Supervisors of contractor
personnel receiving their initial supervisorial assignment would have
only ten days to complete initial training. Given the higher rate of
positive tests among contractor personnel, it is particularly important
to ensure that contractor supervisors complete their training either
before or very soon after they assume their duties. Although the NRC
considered amending the rule to clarify requirements concerning
situations in which contractor, and possibly some licensee, supervisors
do not have unescorted access privileges themselves but supervise
people who do have such privileges, it believes the following guidance
should suffice. The NRC expects that those supervisors who do not come
on site would be trained in drug recognition, behavioral observation,
and procedures for initiating corrective action. The NRC also expects
that, while on site, these workers are observed by someone trained in
these matters.
The NRC is concerned that some licensees may have appointed people
as ``acting'' supervisors for periods of less than three months and
have given these people none of the programmatic training required by
this section. The NRC believes that even ``acting'' supervisors must be
trained in the five topics appearing in Sec. 26.22(a) as soon as
feasible.
The NRC is also proposing to allow a written examination that
demonstrates an adequate knowledge of pertinent FFD issues and material
to be used in lieu of refresher training for supervisors and escorts in
two out of every three years. Allowing the use of a written exam would
increase flexibility without compromising the integrity of FFD programs
and may decrease administrative expenses. The NRC has declined to
change the nominal 12-month frequency associated with this refresher
training for supervisors and escorts as it proposes to do for the
policy communications and awareness training required by Sec. 26.21(b).
Supervisors and escorts must, for example, be able to recognize drug
use or degradation of performance of the
[[Page 21112]]
people working around them. Having training, or a written examination
in lieu of training, at an interval of more than 12 months may not be
sufficient to ensure that supervisors and escorts would remain diligent
and effective in performing these functions.
Another proposed amendment would allow licensees to accept the
training of people who have been subject to a Part 26 program at
another site and have had initial or refresher training (or testing in
lieu of refresher training) within 12 months before assignment to
supervisory duties. This proposed revision would facilitate the
movement of supervisory personnel among licensees and decrease licensee
costs for training individuals in a number of common areas that are
consistent across licensee programs. As noted previously, because there
are some differences among licensees, new employees should be trained
in those aspects of the licensee's program that are site specific.
As noted by the Commission's regulatory review group, behavioral
observation training as described in Sec. 26.22(a) should not focus
solely on substance abuse. Instead, it should also provide managers and
supervisors training in appropriate actions to take (e.g., referral to
EAP) when individuals have FFD problems other than substance abuse that
affect them (e.g., stress, fatigue).
Section 26.23 Contractors and Vendors
This section currently requires that personnel who have been denied
access or removed from activities within the scope of Part 26 for
violations of an FFD policy will not be assigned to activities within
the scope of Part 26 without the knowledge and consent of the licensee.
During the first five years of FFD program operations instances
occurred in which personnel with a history of substance abuse known to
the contractor employer were sent on site without the licensee being
informed of such history. Therefore, this section is revised to make
clear that persons with a known (to the contractor or vendor) history
of substance abuse must not receive these assignments without the
knowledge and consent of the licensee.
The NRC understands that some contractors have requested escorted
access for individuals with a drug history in order to avoid informing
the licensee. The Commission desires comments as to whether the rule
should be revised so that this practice is no longer permitted.
Section 26.24 Chemical Testing
The NRC proposes to revise the descriptions of the four types of
testing that are currently required. The proposed changes are intended
to rectify inconsistent interpretations of testing requirements that
have appeared across the industry during the five years of FFD program
operations. In Sec. 26.24(a)(1), chemical testing before granting
unescorted access would be referred to as ``preaccess testing.'' It
continues to be the NRC's intention that any test, whether before or
after the beginning of a person's term of employment with the licensee,
that is performed with the intent that it may be a test as required by
Sec. 26.24(a)(1) must meet the standards set forth in Part 26 and be
reported to the NRC as a preaccess test. One proposed amendment to this
paragraph designed to reduce unnecessarily redundant testing of
applicants for access privileges, would allow licensees to consider any
drug and alcohol test meeting Part 26 standards and performed within 60
days before the granting of unescorted access to serve as a preaccess
test. A test performed by another licensee or under a testing program
required by the U.S. Department of Transportation are examples of tests
that would qualify as preaccess tests under this proposed revision. In
such circumstances, the NRC would expect that licensees would use a
dependable means of confirming that the person seeking access had
actually been tested. This could be accomplished by the electronic
exchange of pertinent information among licensees using a computerized
data base that the industry is currently considering for
implementation.
As another clarification of the NRC's original intent, as described
in item number 4.5 of NUREG-1385, ``FFD in the Nuclear Power Industry:
Responses to Implementation Questions,'' Sec. 26.24(a)(1) would be
amended to explicitly prohibit the granting of unescorted access until
the person's negative preaccess test result has been obtained. However,
another change would allow some relief from this requirement.
Unescorted access could be granted before receipt of a negative test
result if the person seeking access has no history indicating the use
of illegal drugs or the abuse of legal drugs and has either had a
negative result on a test meeting Part 26 standards performed within
six months before the granting of unescorted access or been covered by
a program meeting Part 26 standards for two consecutive weeks during
that six-month period. This relief from the requirement to obtain a
negative test result before the granting of access is based upon
industry experience of the demonstrated reliability of workers who have
been covered by a rigorous program in the past. In these circumstances,
the NRC expects that licensees would confirm the occurrence of such
tests or such coverage. These proposed revisions are intended to
reiterate the importance attached to establishing an individuals'
fitness status before unescorted access is granted. At the same time,
these revisions would allow some efficiencies borne out by industry
experience in the granting of access without compromising public health
and safety. Some additional relief would be provided where the
individual is transferring from another licensee. In this case, if the
individual has been covered by an FFD program for 30 of the previous 60
days, no specimen need be collected and tested.
Other proposed changes to this section (Sec. 26.24(a)(2)) would
more clearly describe the full meaning of the currently required
attributes of random testing. Some licensees who randomly tested only
during weekday day shifts provided predictable gaps in testing. People
working during evenings and on weekends knew they would not be tested.
Workers who were randomly selected for testing, but did not happen to
be on site at the time scheduled for specimen collection because they
normally worked off site or worked a night or weekend shift, were
deleted from the list of people to be tested that day and other workers
who were present substituted in their place. Thus, not all workers had
an equal chance of being tested. All testing personnel and employees
must be made aware that tests are truly random and unpredictable, and
therefore that unannounced tests may occur during any day or night duty
hours. Predictable patterns of random testing are prohibited by the
rule. The proposed rule changes would create no new random testing
requirements, but would instead clarify currently existing requirements
that random testing be unpredictable and conducted at various times
during the day. As discussed in item number 4.6 of NUREG-1385, which
points out that HHS's ``Medical Review Officer Manual'' suggests that
random sampling procedures should permit no ``safe periods'' for any
employee: ``Each work day should present each employee with a new
opportunity of having to produce a sample. * * *''
A provision would be added to clarify that reasonable efforts must
be made to
[[Page 21113]]
test persons selected for random testing. For persons off site and
within a reasonable traveling time and distance, the NRC expects
collection of specimens be completed as promptly as notification and
travel can be accomplished. For other persons selected for random
testing, the NRC expects that upon their return to the site they be
promptly notified and tested under the provisions of Sec. 26.24(a)(2)
and that the test would be recorded as a random test.
A proposed amendment would provide flexibility to conduct for-cause
tests (Sec. 26.24(a)(3)) no more than 2 hours for the alcohol part of
the test and 8 hours for the drug part of the test following an
indicated need for testing. This change is intended to accommodate
situations where no collection personnel are on site and need to be
called in or the individual needs to be transported to another location
for testing. While it is in the best interests of both the licensee and
the worker in this situation to collect the specimens as soon as
possible, as currently required, more flexibility is appropriate. A
shorter time is specified for alcohol because of the more rapid
metabolism of this substance.
Other additions to this section would be clarification of the
conditions that initiate a for-cause test and clarification that an MRO
or other licensed medical person must determine the fitness for duty of
an individual tested for cause before that worker may return to duty.
Although the NRC considered amending the rule to clarify requirements
concerning situations in which a worker may be potentially impaired
from causes that would not be detectable by drug and alcohol testing,
it believes the following guidance should suffice. Although impairment
caused by factors other than substance abuse is usually not a violation
of the FFD rule by the worker, it is the responsibility of the licensee
to assure that no impairment, regardless of cause, threatens public
safety.
The NRC has received, but declined to adopt, recommendations that
this section be revised to authorize licensees to administer an
``alcohol-only'' test in certain situations. Under this recommendation,
only a breath test would be required when conditions that directly
indicate alcohol use, such as alcohol on the breath, create a
reasonable suspicion that the person may have misused alcohol in
violation of the licensee's fitness-for-duty policy. The NRC believes
that allowing an alcohol-only test in these circumstances would be
inappropriate. It is preferable to perform both an alcohol test and a
drug test, whether the alcohol test is positive or negative, to fully
investigate the individual's fitness for duty. However, if the alcohol
test is negative and the individual is determined fit by a designated
licensee representative qualified to make the determination, the
individual could be returned to duty pending laboratory testing of the
urine specimen and receipt of urinalysis results. The Commission
believes that this provides an appropriate balance between assurance of
a thorough inquiry and determination of fitness and reduction of the
impacts caused by time away from the work station.
The requirements pertaining to follow-up testing (Sec. 26.24(a)(4))
would be clarified by incorporating the provisions of Sec. 26.27 (b)
(4) to make explicit that all people to whom unescorted access is
reinstated under Sec. 26.27(b) must be subject to unannounced and
unpredictable testing for at least three years following reinstatement.
The duration of followup testing is supported by research which
indicates that chronic abusers of alcohol and other drugs usually need
several years to recover from their habits. Under these proposed
amendments, licensees would be required to adopt a program that is
tailored to the individual's medical history and that meets these
minimum requirements. These amendments are intended to clarify the
current conditions under which licensees can reinstate unescorted
access following a first or second violation of an FFD policy. A
proposed requirement that the testing be unpredictable is added to
conform the followup testing to the existing requirements for random
testing.
The NRC proposes to add a fifth
type of required chemical testing refer-
red to as ``return-to-duty'' testing
(Sec. 26.24(a)(5)). In its current form, the rule does not clearly
state the Commission's intent that licensees should test personnel
having unescorted access when they return to work after extended
absences. The NRC staff is aware that most, but not all, licensees are
already testing people when they return to their sites after extended
absences. The proposed new Sec. 26.24(a)(5) would require return-to-
duty testing when workers seek to regain unescorted access to protected
areas in two types of circumstances. First, workers seeking to regain
unescorted access after having been denied access under the provisions
of Sec. 26.27(b) would be tested and a negative result obtained before
access is restored. Second, a worker who seeks to regain access at a
particular licensee's plant after an absence from the possibility of
being tested under that licensee's FFD program for more than 60 days
would have to be tested under this requirement. Provisions are made in
the rule to lessen the impact. This proposed revision is also intended
to clarify expectations regarding individuals selected for random
testing who are away from the site and not available for testing. The
NRC staff understands that some licensees are currently calling people
in for random tests from long distances (e.g., a 2- to 4-hour drive
each way, cross-country flights, overnight stays). Some licensees use
mobile collection facilities or teams to travel to the persons selected
for testing. The NRC staff is also aware that many licensees are
routinely testing people such as utility headquarters staff,
contractors, and consultants who come to the site only infrequently but
may have access status. The new return-to-duty testing requirements and
the revisions to the pre-access and random testing requirements
(Sec. 26.24(a) (1) and (2)) are intended to provide licensees the
explicit flexibility to adjust their testing programs to eliminate
unnecessarily ``heroic efforts'' to test.
The 60-day period was chosen in order to be consistent with the
current preaccess processing standards in NUMARC 91-03, ``Nuclear Power
Plant Personnel Access Authorization Data Exchange Guidelines,'' dated
October 1992. The industry guidelines provide that to be issued a badge
in a situation where an individual has an existing access
authorization, the individual must either be currently covered by an
FFD program including random testing, or have satisfactorily completed
preaccess drug and alcohol testing within 60 days before badging, and
be subject to a behavioral observation program and an FFD program. The
industry guidelines also provide that the individual's activities
should be checked if a licensee or contractor/vendor employee had been
away from a licensee, or approved contractor/vendor, behavioral
observation program for more than 30 consecutive days. The industry
guidelines also provide that suitable inquiry should be updated if
reinstatement of access is requested for an individual who has been
away from an FFD program for a period of 30 days or more.
For workers who have been absent from the possibility of being
tested under the licensee's program for more than 60 days, any drug or
alcohol test meeting Part 26 standards and performed within 60 days
before the granting of unescorted access could serve as the return-to-
duty test. The returning worker would have to obtain
[[Page 21114]]
a negative test result before returning to work unless he or she has no
history indicating the use of illegal drugs or the misuse or abuse of
legal drugs and has either had a negative result on a test meeting Part
26 standards performed within six months before the reinstatement of
unescorted access or been covered by a program meeting Part 26
standards for two consecutive weeks during that six-month period. As
was adopted for preaccess testing, tests performed by another licensee
or under a testing program required by the U.S. Department of
Transportation are examples of tests that would qualify as return-to-
duty tests under this proposed revision. In such circumstances, the NRC
would expect that licensees would use a dependable means of confirming
that the person seeking access had actually been tested or been covered
by another program. This could be accomplished, for example, by the
electronic exchange of pertinent information among licensees using a
computerized data base that the industry is currently considering.
Various proposed editorial changes to Sec. 26.24(d) would leave its
requirements essentially unchanged from the amendment to this paragraph
published by the NRC on August 26, 1991 (56 FR 41922).
The NRC is proposing a new paragraph (Sec. 26.24(e)) that would
require that licensees keep to a minimum the time between notifying
individuals to be tested and the actual collection of specimens. This
requirement is intended to eliminate a significant vulnerability (time)
in the testing process. Time is very important to persons attempting to
avoid detection. Time enables them to flush themselves, obtain
surrogate specimens, or obtain materials to dilute or adulterate their
specimens. For example, an investigation was conducted to determine why
two adjacent sites, drawing their workforce from the same geographic
area, had significantly different positive rates for random tests. It
was determined that different time intervals between notification and
collection were the cause of the discrepancy. The licensee with the low
rate had a 2-hour notification policy not vigorously enforced; the
licensee with the higher rate had a 15-minute notification policy which
it aggressively enforced. A DOT study showed an increase in the
positive rate when there was little or no prior warning of specimen
collection. Whereas ``normal'' random testing of motor carrier
personnel was positive at a 2.5% rate, roadside stops produced at a
4.8% positive rate. In response to that experience, DOT revised its
rule to require the person, upon notification, to immediately proceed
to be tested. NRC inspections and surveys indicate that some licensees
keep workers on the job and test them only at the end of a shift even
though they have been notified that they are to be tested hours before.
In other cases, licensees permit delaying tactics that result in
lengthy periods between notification and testing. In both of these
cases, alcohol can be metabolized below detectable levels and the
person can flush himself or herself, to some degree, of drugs. Some
licensees release workers for tests in a manner that allows them ample
opportunity to obtain materials that might subvert the test results
(e.g., adulterants or surrogate samples kept in a locker or vehicle).
The NRC understands that operational necessity may prevent the tested
person from reporting immediately and that being escorted between
notification and test may be an unreasonable burden. However, several
licensees have reduced the notification time by using the supervisor to
coordinate the worker's availability for testing and withhold
notification until the individual must proceed to the collection site.
Licensees report that this approach does not cause any burden or
inconvenience; it is merely a different way of doing things. One
licensee reported that it escorted persons selected for random testing
without giving them prior notice, which produced a low number of
questionable specimens (NUREG/CR-5758, ``Fitness for Duty in the
Nuclear Power Industry: Annual Summary of Program Performance
Reports,'' CY 1994, Volume 5, page C-5). Therefore, the Commission
expects that licensees will assure that opportunities for subverting
the test are eliminated as much as is practicable.
Section 26.24(e) (paragraph (f) in the proposed rule) currently
requires that MROs' review of test results be completed and licensee
management notified of those results within 10 days of the initial
positive screening test. The intent of this requirement is to ensure
that results are obtained within a reasonable time after specimen
collection. Industry experience has indicated in some cases that the
current requirement is impractical. In order to make this requirement
more effective across the industry, the NRC is proposing to require
that MROs' review of laboratory test results be completed and licensee
management notified ``as soon as practicable'' after specimen
collection and no more than 14 days after the collection of a specimen.
Because many licensees conduct on-site screening tests, the
``collection of a specimen'' standard would establish a more consistent
and controllable time line than ``initial screening test.'' The
licensees conducting initial screening tests on site would have the
same amount of time to review the HHS-certified laboratories' reports
as do those licensees not conducting onsite testing. Experience has
shown that the majority of certified laboratories take only 1 to 3 days
from receipt of a specimen to screen and confirm tests; isolated
exceptions are usually caused by testing for 6-acetylmorphine (6-AM),
formerly referred to as 6-monoacetylmorphine (6-MAM), and occasionally
by unusual technical problems. The Commission believes that most test
results should be known to an MRO within 5 to 7 days from specimen
shipment to the laboratory. The Commission has no great concern where
there is a legitimate technical basis for a short, reasonable delay by
the laboratory, for example, where a specialized low-volume test, such
as 6-AM, is done twice a week rather than every day. This revision
would require, therefore, that MROs must advise licensee management of
available test results and of the progress of the review if the review
has not been completed within 14 days of the specimen collection. While
slightly relaxing the test result reporting requirements, the NRC would
still expect MRO reviews to be completed as soon as practicable, and,
in accordance with a proposed clarification of Section 2.9(c) of
Appendix A, that the MRO notify management immediately after the
determination of a positive test result or other violation of FFD
policy.
The NRC also proposes to clarify Sec. 26.24(f) to require that the
MRO must report all violations of the licensee's FFD program to
management in writing and in such a manner that confidentiality is
ensured. This requirement is also proposed as new paragraph (i) in
Section 2.9 of Appendix A, which addresses reporting requirements and
the review of test results. This provision is simply a clarification of
existing practice and an adoption of a change made to the HHS
guidelines in June 1994, and would not place a significant burden on
licensees since it would require that only FFD program violations,
rather than all test results, be reported in writing to management.
Requiring that all determinations of FFD program violations be
submitted in writing will assist in preventing reporting errors.
Furthermore, although it is currently common practice to submit such
[[Page 21115]]
information in a manner that ensures confidentiality, the NRC believes
that due to the sensitive nature of the information this provision
should be explicitly required, as HHS does in its guidelines.
The NRC proposes to modify Sec. 26.24(g) with several editorial
changes to clarify requirements for performing screening, confirmatory,
and blind performance tests at HHS-certified laboratories. These
changes serve to clarify and explicitly state the currently existing
practice by licensees. In addition, this paragraph and Sec. 26.24(d)
would require licensees to ensure that all collected specimens are
tested and that laboratories report results for all specimen tests
performed. This provision serves to clarify existing requirements,
would be a companion to the change to Sec. 26.24(f), and would be an
adaptation of a change made to the HHS guidelines in June 1994, in
which HHS required written reports on all specimens, both positive and
negative, to ensure that all specimens had been tested and all results
reviewed by the MRO.
The NRC is proposing to require that a confirmatory test for
alcohol be performed if the screening test indicates a blood alcohol
concentration of 0.02 percent or greater instead of 0.04 percent as
currently required (Sec. 26.24(h)). In cases where the confirmatory
test indicates a blood alcohol concentration between 0.02 percent and
0.04 percent, the result would have to be forwarded to the MRO for
review and, if appropriate, back calculation (see new Section 2.9(h) of
Appendix A). The purpose of this procedure would be to determine
whether the tested person had a BAC of 0.04 percent or greater,
indicating a violation of the FFD rule, at any time during the work
shift.
Section 26.24(h) currently provides for a blood test to be
administered if the tested person demands ``further confirmation'' of a
positive confirmatory test for alcohol. The NRC is proposing to revise
the regulatory language to better reflect the purpose of blood tests in
that they would be used for providing additional information that could
be considered during an appeal pursuant to Sec. 26.28. Furthermore,
licensees would be required to ensure that the blood specimen is drawn
promptly after the confirmatory breath analysis. The result of the gas
chromatography analysis of the blood specimen need not necessarily be
measured against the alcohol cut-off level. Instead, the MRO should
determine in these cases whether it is appropriate to extrapolate back
in time to estimate the highest BAC that the worker had while on duty.
In a related matter, the NRC desires data on the number of times blood
specimens have been drawn and any instance where the BAC results were
overturned. Approaches licensees have taken to maintain this capability
and the associated costs would be useful for evaluation of possible
future changes in this requirement.
In another revision to this section, the NRC is proposing a new
paragraph (Sec. 26.24(i)) to address cases where an individual has a
medical condition that makes collection of breath, blood, or urine
specimens difficult or hazardous. The MRO, in consultation with the
worker's treating or private physician, would be authorized to
determine a method of specimen collection provided the methods chosen
can achieve comparable results. The Commission anticipates that these
occasions, which would include, for example, post-accident testing of
an injured individual, would be extremely rare.
In connection with the blood tests which may be performed under
Sec. 26.24 (h) and (i), the NRC notes that the Occupational Safety and
Health Administration (OSHA) has determined that some employees face a
significant health risk as the result of occupational exposure to blood
and other potentially infectious materials because the materials may
contain certain bloodborne pathogens. OSHA published a final rule in
the Federal Register on December 6, 1991 (56 FR 64004), that
establishes requirements applicable to all occupational exposure to
blood or other potentially infectious materials. This coverage appears
to include personnel involved in the collection and handling of blood
specimens collected pursuant to the NRC FFD rule. The OSHA rule
requires employers that have one or more employees with this
occupational exposure to take several measures to minimize the
exposure. These measures include determining employees' potential
exposure, establishing a written Exposure Control Plan designed to
eliminate or minimize employee exposure, and taking various precautions
to prevent contact with blood in the course of work. The NRC
anticipates that licensees will evaluate their responsibilities under
this OSHA rule.
Section 26.25 Employee Assistance Programs (EAP)
The NRC proposes to revise this section by replacing the permissive
``should'' with the mandatory ``must'' to clarify its original intent
that licensees design their employee assistance programs to achieve
early intervention and must provide for confidential assistance. While
actually achieving early intervention in all situations where
employees' problems could adversely affect on-the-job performance may
not be possible, it is reasonable to expect that all licensees' EAPs be
designed to achieve this goal and not include obvious impediments to
early intervention. This would assure that self referrals are kept
confidential and do not result in punitive action. The NRC wishes to
emphasize that Employee Assistance Program staff shall inform licensee
management when a person constitutes a hazard to himself or herself or
others and that self-referral does not influence in any way the
determination of an FFD violation.
Section 26.27 Management Actions and Sanctions To Be Imposed
The NRC proposes changes throughout this section to require the
same sanctions for alcohol violations as currently exist for use of
illegal drugs. Explicit sanctions were not contained in the original
rule because the NRC wished to study the matter further. As a result of
further study, the NRC concludes that impairment caused by alcohol
abuse creates a safety risk that is fundamentally similar to the risk
posed by the use of illegal drugs. Both types of abuse involve
violation of explicit licensee policies, are unacceptable in the
nuclear power industry, and should strongly be discouraged. Currently,
licensees vary widely in their responses to alcohol abuse with
sanctions ranging from a three-day suspension to termination. The FFD
rule's lack of explicit minimum sanctions concerning alcohol has
created problems for many licensees in negotiating and defending
sanction decisions. Creating minimum sanctions for alcohol violations
that are equal to those of illegal drugs will assist licensees in
dealing with these situations while sending a strong message to workers
about the risks involved in abusing alcohol. As discussed under the
proposed changes to Sec. 26.20, it is important for licensees to ensure
that their employees understand the several factors related to alcohol
consumption that could result in a violation of the licensee's FFD
policy.
Section 26.27(a) would be revised to clarify certain aspects of the
requirements for the written statement obtained from persons seeking
unescorted access and for the conduct of suitable inquiries. In both
cases, the revisions would require licensees to determine whether the
person has a history of substance abuse or has previously violated a
licensee FFD
[[Page 21116]]
policy. These changes are being proposed with the intention of
requiring the gathering of more complete information on the backgrounds
of applicants for unescorted access, particularly as to potential
problems with the abuse of alcohol. In addition, the history, except
for removal from activities within the scope of this part due to
actions taken as the result of an FFD policy, would be limited to the
last 5 years. It should also be noted that the proposed revisions are
intended to ensure consistency between the suitable inquiry aspects of
both the access authorization rule and the FFD rule and that one
suitable inquiry for each worker should be sufficient to fulfill the
requirements of the two rules. As in the Access Authorization program,
``best efforts'' requirements of Sec. 26.27(a)(3) are accomplished
through contacts with previous employers. In addition, fitness history
need not be obtained for those covered by other programs or absent for
30 days or less.
The NRC has received recommendations that a standard form be
available for all licensees' use in performing suitable inquiries into
individuals' backgrounds as required by this section. The NRC will
defer to licensees should they wish to develop and use this type of
form.
There have been a few reports of instances where a contractor or
vendor employee with concurrent unescorted access to several power
reactor sites had tested positive and that information was not shared
with the other licensees. Although the individual was denied access by
the testing licensee, the unescorted access status was continued by the
other licensees. The NRC considered requiring licensees to assure that
such notifications are made or to make periodic checks with other
licensees and contractor employers but believes that the licensees'
procedures to implement the access authorization rule (10 CFR 73.56)
should facilitate the sharing of the information.
Section 26.27(b)(1) would be revised to clarify several points.
Applicants would be added to the types of people to be denied
unescorted access if their fitness is questionable. Violations of FFD
policy, such as refusals to test or subversion of the testing process,
is added as a basis for denial. The successful resolution of the
impairing or questionable condition has been added as a condition to
assignment of duties, and a more systematic review of the fitness of
all personnel being returned to duty whose fitness had been deemed
questionable would be required. This action is being taken because
there have been several instances in which licensees did not remove or
delayed removal of workers whose fitness was questionable and
``automatically'' returned workers to duty without a test or adequate
determination of fitness. Companion changes are proposed for Sec. 26.3,
concerning medical determination of fitness, and Sec. 26.24(a),
regarding for-cause and return-to-duty testing.
The NRC proposes various amendments to Sec. 26.27(b) (2) and (3)
[formerly one paragraph (2)]. The first amendment would more clearly
specify that confirmed positive drug and alcohol testing determinations
are to be considered violations of FFD policy. Another amendment would
clarify that people who are suspended because of policy violation are
still to be covered by the licensee's FFD program with respect to
behavioral observation, chemical testing, and sanctions for violations
and that a positive test result during the assessment or treatment
period would constitute a second positive test. In a related matter,
the NRC expects that, in those rare cases when an individual is
randomly tested before the results of a previous test are known to the
individual and both results are positive, the licensee will consider
whether the second test result is likely to be the result of the use
indicated by the first test and, if not, declare the second test to be
a second positive and take appropriate action. As amended, this
paragraph would also require that a person who is reinstated following
a policy violation must successfully complete a return-to-duty test and
be subject to subsequent follow-up testing.
Section 26.27 (b) (4) and (5) (formerly paragraphs (3) and (4))
would be revised to fully recognize the abuse of alcohol as an FFD
violation. The NRC also proposes to revise paragraph (b)(5) to more
directly express its intention that a person must be determined to be
fit to safely and competently perform activities under Part 26 by an
appropriate licensee manager and the MRO or other qualified physician
before being returned to those activities. Like other proposed
amendments to this section, these amendments would be intended to
elevate the importance given to licensee decisions regarding unescorted
access reinstatement following FFD policy violations.
Section 26.27(c) would be clarified so that the exact act that
violated the FFD policy is recorded and provided in response to an
inquiry. Subversion of the testing process would be added to the
examples of violations that must be recorded and provided in response
to a suitable inquiry. Each of these examples of employee activity
would be a violation of the licensee's FFD policy. A new provision
would require that any attempt to subvert the testing process must
result in denial of unescorted access for a minimum of three years
which would be consistent with the sanction required by
Sec. 26.27(b)(3) for a second violation of a licensee's FFD policy.
This sanction was chosen because the NRC wishes to convey the
seriousness of such acts. Lastly, paragraph (c) would be revised to
allow licensees to dispose of records five years following denial of
any access authorization resulting from the activity. These revisions
would establish a basis for consistent minimum treatment of these
violations across all licensee programs for employee activities that
have resulted in varying licensee response during the first five years
of FFD program operation.
The NRC also proposes to revise paragraph (d) of Sec. 26.27 to
direct licensees to treat NRC contractors similarly to NRC employees if
a licensee believes an NRC contractor to be under the influence of any
substance or otherwise unfit for duty.
The NRC is aware that the requirements of the American with
Disabilities Act of 1990 (ADA) may have implications for licensees'
compliance with the requirements of Sec. 26.27. The employment
provisions of the ADA, which became effective on July 26, 1992, require
employers with 25 or more employees to protect disabled persons from
discrimination in the workplace. People who have previously been
addicted to drugs or alcohol but who have been successfully
rehabilitated, or can demonstrate a successful period of abstention or
negative test results, are among those that the ADA protects. It is the
NRC's understanding that a person who has casually used drugs in the
past but was not addicted to those drugs cannot claim the ADA's
protection. The Act specifically excludes from its protection employees
or applicants who are current users of illegal drugs. The Act also
specifies that covered entities may require employees to comply with
the FFD regulations of the NRC to the extent such employees are covered
by these regulations (Sec. 104(c)(5)(B), Pub. L. 101-336, 42 U.S.C.
12114; see also 29 CFR 1630.16(b)).
The Equal Employment Opportunity Commission has published the
Americans With Disabilities Act Technical Assistance Manual which
somewhat clarifies the meaning of ``current use'' of illegal drugs.
According to the Manual, ``current use'' is drug use that has occurred
recently
[[Page 21117]]
enough to justify an employer's reasonable belief that involvement with
drugs is an on-going problem. For purposes of taking an employment
action, current drug use is to be determined on a case-by-case basis
and is not limited to the day of use or recent days or weeks. Clearly,
when determining whether a particular person is a current user of
drugs, and therefore not eligible for ADA coverage, the required amount
of time that must have elapsed since a person's last use of drugs must
depend to a large extent on the nature of the particular employment
context in which an employment action is being considered. This is
confirmed by the Manual when it states that an employer may take an
employment action against an employee with a history of illegal drug
use if it can demonstrate that the individual poses a direct threat to
health or safety because of the high probability that he or she would
return to illegal drug use.
The NRC's policy, as reflected in 10 CFR Part 26, is that until a
person can show that he or she has abstained from substance abuse for
at least three years, there is a continuing probability of resumption
of substance abuse that is too high, given the exceptional safety
concerns of the nuclear power industry. This has been supported by
medical evidence and clinical experience. Given the heightened safety
concerns of the nuclear power industry, it is the NRC's view that a
person is a current user and not a disabled person under the ADA
because of drug or alcohol abuse until that person has demonstrated
abstinence from substance abuse for a minimum of three years after a
positive test. Even when considered disabled because of drug or alcohol
abuse, a person covered by a program pursuant to 10 CFR Part 26 is by
terms of the Americans With Disabilities Act still subject to the NRC's
fitness-for-duty regulations.
Section 26.28 Appeals
The NRC is proposing amendments to the right to appeal granted by
Sec. 26.28. This section currently requires that people subject to the
rule have an opportunity to appeal positive drug and alcohol test
results. In keeping with revisions to several other sections that would
be intended to counter testing subversion, an amendment would extend
this right to appeal to all determinations of FFD violations.
The NRC proposes to clarify that the right to appeal includes
applicants for unescorted access. The NRC understands that some
licensees did not provide an appeals process to persons who tested
positive on pre-access tests. The factors that could produce false
positives among licensee employees and contractors (e.g.,
administrative errors, medical prescriptions) are equally likely to
occur during pre-access testing of applicants for unescorted access.
(Note that a change to Sec. 26.24 will permit licensees to consider any
test meeting the Part 26 standards as a pre-access test. Those
standards include the appeals process under Sec. 26.28, and apply to
any test that the licensee plans to subsequently use as a pre-access
test.) If applicants for unescorted access are not provided an appeals
process, it is possible that some of them will be effectively barred
from the industry based on test results erroneously determined as
positive. Providing applicants an opportunity to appeal the validity of
the test result would also enhance program credibility.
The NRC also proposes to clarify the contents and purpose of the
notice to the individual determined to have violated an FFD policy,
clarify that the review process must be objective and impartial,
clarify that the individual may submit additional relevant information,
extend appeal rights to applicants for access, and assure that relevant
records are corrected if an appeal is successful. The NRC understands
that, in some cases, the individual did not understand the purpose of
the appeal process. The NRC also understands that, in many instances,
persons responsible for the initial determination were conducting the
review. The NRC believes that the effectiveness of the FFD program
depends, to a large extent, on the perception by the workforce that the
program is fair and worthy of their support, and that all reasonable
efforts are being made to ensure that any decisions that could affect
their careers are fair and based upon information that is complete and
accurate and forms a sound basis for the decision. The use of even-
handed, fact-finding procedures should ensure that incorrect
determinations that could undermine the quality of a licensee's
workforce and, thereby, be counter to the interests of safety, will not
stand uncorrected.
As a related concern, the NRC has been informed that some licensees
have required individuals to pay for the reanalysis of their specimen
and the analysis of their split sample when pursuing appeals. Having to
pay for the reanalysis can be expected to obstruct the individual's
exercise of the right to appeal the licensee determination of policy
violation as granted by this section. The NRC, therefore, considers
requiring persons covered by the rule to pay for reanalysis of their
specimen or analysis of the split sample to be inappropriate. However,
requiring the person to pay after the fact should these subsequent
tests also be positive would be an acceptable measure to control
unwarranted appeals.
Section 26.29 Protection of Information
The NRC proposes to amend this section to clarify that contractors
and vendors who legitimately seek information for unescorted access
decisions by licensees are authorized to obtain this information.
Contractors and vendors were unintentionally omitted from this
provision in the original rule.
A second proposed amendment would allow disclosure of personal
information collected in compliance with the rule to presiding officers
of judicial or administrative proceedings that are initiated by the
person who is the subject of the information. The purpose of this
amendment would be to allow disclosure to, for example, state agencies
investigating whether the firing of an employee was justified in order
to determine unemployment compensation entitlements. This disclosure
would be permissible as long as the subject employee initiated the
proceeding.
Section 26.29(c) would be moved from current Sec. 3.2 of Appendix A
and amended to clarify that licensees must provide to the subject
individual, upon written request, copies of all records pertaining to
violations of FFD policy, including test results, MRO reviews, and
management determinations pertaining to the individual. Some licensees
have interpreted this section in ways that make it difficult for
workers to obtain their records. For example, some licensees have
allowed the tested persons to see the documents but have not provided
them copies of the documents. This is particularly difficult in the
case of contractor employees who may no longer reside in the plant
area. These actions are contrary to the NRC's intent that persons
covered by the rule have full and convenient access to documents
pertaining to employment actions taken in response to the results of
tests conducted under this rule.
Section 26.70 Inspections
The NRC is proposing to revise this section to clarify its intent
that FFD service contractors must make available for inspection by duly
authorized representatives of the Commission documents, records, and
reports related to the FFD services they provide to licensee,
contractor, or vendor FFD programs. In some instances, contracted
service providers and testing laboratory
[[Page 21118]]
personnel have been reluctant to provide documents to NRC inspectors.
Section 26.71 Recordkeeping Requirements
The proposed amendments to this section would clarify the NRC's
intent that licensees retain relevant records pertaining to
determinations of FFD policy violations, not just records of confirmed
positive test results. These records are to include those related to
personnel actions following policy violation determinations (such as
refusals to test and subversion of the testing process) as well as
those pertaining to the testing process that detects the violations.
This revised wording would clarify licensees' recordkeeping
responsibilities as well as ensure that people covered by the rule
would have sufficient access to documentation of personnel actions that
can substantially affect their work status.
The proposed amendments to this section would also reduce the
reporting frequency for program performance data from semiannually to
annually and add the number of subversion attempts by type to reporting
requirements to support the greater emphasis on subversion elsewhere in
the proposed rule. The NRC has considered, but decided not to adopt, a
recommendation that utilities with more than one site submit only a
single semiannual program performance report for all sites. Such
consolidation of data would prevent analysis of site specific
performance and NRC inquiry into obvious inconsistencies such as large
numbers of positive results at one site and no positives at the second
or neighboring site.
Despite obtaining the FFD programmatic performance information that
has been submitted pursuant to this section for the five years of
program operation, the NRC believes that additional types of
information could be useful in fulfilling its responsibilities of
overseeing licensees' FFD programs and formulating public policy. As
noted in the introduction to this notice, several parties have
recommended that the NRC consider obtaining certain types of
information in addition to those currently required by this section or
now being proposed for inclusion under Sec. 26.73. Such information
could include the number and nature of grievances, arbitration
proceedings, and lawsuits stemming from FFD-related issues; information
related to licensees' EAP programs including types of services
provided, whether such services are provided by licensee or contractor
personnel, employee-to-counselor ratios, the number of personnel who
are admitted to EAP programs by self referral and by supervisory
referral, the reported and diagnosed problems, and overall results of
EAP programs; and laboratory testing results that are being provided to
MROs and what problems MROs are having in interpreting test results and
making judgments as to whether FFD policy violations have occurred.
Having access to this information would enable the NRC to gain a
clearer and more detailed understanding of the actual operation of the
programs. This information would also be useful for purposes of
revising the regulation or providing guidance so that the general
performance objectives stated in Sec. 26.10 can be better achieved. The
NRC, therefore, seeks public comment as to whether Sec. 26.71(d) should
be revised further to require that these types of information be
collected and analyzed by licensees and submitted to the NRC. The NRC
also seeks public comment as to whether the NRC should develop a
management information system similar to that promulgated by DOT and
its operating administrations (58 FR 68194 through 68285; December 23,
1993).
The NRC wishes to acknowledge the usefulness of lessons learned and
program initiatives reported by many licensees that are summarized in
NUREG/CR-5758 each year for licensees to consider and use to improve
their programs and avoid common problems.
Section 26.73 Reporting Requirements
The current rule requires that licensees inform the Commission of
significant FFD events and describes examples of significant events
involving acts by licensed operators and supervisors that must be
reported to the NRC. Item 10.1 of NUREG-1385 emphasized that the NRC
expects licensees to exercise prudent judgment on whether or not
unusual situations should be reported and that the significant events
were 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 NRC is clarifying that significant events are not
limited to those listed and provides additional examples. One of the
proposed amendments would add FFD program personnel, in keeping with
clarifications to the scope of the regulation under Sec. 26.2 (a), as a
class of individuals whose improper acts would be reportable. Another
proposed amendment would expand an example to include that any
violation of FFD policy (e.g., possession of illegal drugs, refusal to
take a test, attempt to subvert the testing process) by a supervisor,
licensed operator, or FFD program personnel must be reported in
contrast to the current example which describes reporting only
confirmed positive test results.
Section 26.80 Audits
This section would be revised to permit licensees some discretion
in conducting audits and to address a petition for rulemaking (PRM-26-
1) filed on January 19, 1994. Rather than emphasizing compliance with a
requirement to conduct an audit at a fixed annual frequency, licensees
would be responsible for determining the appropriate frequency, scope,
and depth of auditing activities within a 3-year period based upon a
review of program performance indicators. These performance based
audits would be conducted so that all program elements are adequately
covered at least once during the 3-year period. In addition, the
interval between audits of a program element would be relaxed to 36
months. The NRC is specifically interested in public comments on
program performance indicators in addition to those contained in the
text of the proposed amendment to the rule and whether they should be
added to the rule or included in a guidance document. This relaxation
of audit requirements would not be extended to contractors and vendors,
whether they are implementing any portion of a licensee's program for
their employees under the provisions of Sec. 26.23, or providing
contracted FFD services, such as specimen collection, testing, and MRO
reviews. The amendments to this section would also clarify that
licensees must continue to audit their HHS-certified laboratories on an
annual basis.
The NRC recognizes that FFD is an evolving discipline and that new
issues and problems will continue to arise. In some cases, turnover of
FFD program personnel further exacerbates the problems. There is a
frequent turnover in the contracted services, such as specimen
collections, MRO reviews, and EAP services. Licensee audits have found
many problems that were associated in some way with personnel changes.
A proposed amendment to this section would require licensees to audit
program elements that may potentially be affected by significant
changes in personnel, procedures (e.g., specimen collection, testing,
and MRO reviews
[[Page 21119]]
and reports), or equipment as soon as reasonably practicable but no
later than 12 months after the changes. The purpose of these focused
audits would be to assure that the change has not adversely affected
the operation of the particular program element or function in
question. One of the clear lessons of the early period of this rule's
implementation during 1989 to 1991 was that licensees that performed
early pro-active audits of their FFD programs were able to more easily
and effectively correct programmatic problems and achieve effective
program operations than those that waited the full nominal 12-month
period before auditing their programs. Accordingly, this aspect of the
performance based audit program would help ensure that whatever
programmatic problems that may result from significant changes in
personnel, procedures, or equipment will be detected and corrected on a
timely basis.
Licensee audits of HHS-certified laboratories continue to find
problems. In one case, the licensee's auditors had found sufficient
problems in the first part of an audit to issue a stop-work order. The
laboratory subsequently lost its HHS certification. Therefore, based on
experiences gained to date, the NRC continues to believe that licensees
must continue to audit at least annually the quality of contractor- or
vendor-performed program elements, particularly when such activities
are provided off site or are not under the direct, daily supervision of
the licensee.
With respect to the petition for rulemaking, which was filed with
the Commission by Virginia Power and assigned Docket No. PRM-26-1 on
January 19, 1994, the petitioner requested that the Commission's
regulations be amended to relax the existing mandatory audit frequency
and require each licensee to audit its FFD program nominally every 24
months instead of nominally every 12 months with additional audits if
performance warrants.
The petitioner requested the change based on its contention that
the present requirement is resource intensive but of marginal
importance to safety. The petitioner's further basis was that the
industry's performance in ensuring a drug-free workplace has been very
effective, the frequency and extent of auditing should be based on the
need to assess performance, and that the licensees need increased
flexibility to concentrate available audit resources in areas of
observed weakness rather than mandatory audits of marginal safety
significance. The petitioner stated that such a change would be
consistent with audit requirements concerning operational safety, and
that the blind performance test procedures and the quality controls
required by Section 2.8 of Appendix A to 10 CFR Part 26 provide
sufficient controls to ensure continued reliability and accuracy of the
chemical testing. The petitioner indicated that its proposed change is
not intended to preclude additional or more frequent audits if
performance trends indicate additional overview is necessary.
The NRC believes that its proposed changes would go beyond that
requested by the petitioner in that the interval for auditing the FFD
program would be 3 years instead of 2, and the actual interval of the
audits would be based more on need, as demonstrated by performance,
than at a fixed interval. Therefore, adoption of the proposed change by
the NRC would grant the petitioner's request with respect to audits of
licensee programs. However, the NRC believes that licensees must
continue to vigorously audit contractor/vendor-performed program
elements, and has maintained the existing frequency of these audits.
The NRC understands that licensees have assumed that the term
``audit'' in Part 26 means a quality assurance (QA) audit that conforms
to their normal audit program requirements and American National
Standards Institute (ANSI) standards, such as ANSI N45.2, ``Quality
Assurance Program Requirements for Nuclear Facilities,'' ANSI N45.2.12,
``Requirements for Auditing of Quality Assurance Programs for Nuclear
Power Plants,'' ANSI N45.2.23, ``Qualifications of Quality Assurance
Program Audit Personnel for Nuclear Power Plants,'' and ANSI N.18.7,
``Administrative Controls and Quality Assurance for the Operational
Phase of Nuclear Power Plants.'' The NRC does not require that these
audits be performed by the QA organization in accordance with the QA
program commitments for the conduct of audits. As stated in the current
rule, the NRC expects that these audits must be conducted by
individuals who are qualified (technically competent) in the subject(s)
being audited and are independent of the program (to assure objectivity
and no conflict of interest). At the licensee's option, the QA
organization may perform, lead, or assist in these audits.
The following discussion describes the changes to Appendix A to
Part 26 that are being proposed and the reasons for the changes.
Section 1.1 Applicability
Numbering changes to this section are being proposed to ensure
uniform style and format throughout the rule.
Section 1.2 Definitions
Proposed changes to this section include deletions of defined terms
that are either redundant with definitions in Sec. 26.3, were moved to
Sec. 26.3, or are clear in the context of this Appendix. A proposed
revision would define ``limit of detection'' (LOD) which is now used in
the rule. Another proposed amendment would delete the term ``permanent
record book.'' This change would make the Appendix consistent with
recent amendments to the HHS guidelines and the Department of
Transportation FFD regulations that eliminated the requirement for a
permanent record book. Because HHS no longer requires a permanent
record book, the NRC proposes to remove requirements for a permanent
record book throughout the rule. The permanent record book was
originally required based on the belief that such a book was necessary
to ensure that critical information regarding collection and testing of
each individual specimen was recorded. However, the FFD drug testing
program specified in Part 26 requires that all information on
individual tests be recorded on the chain-of-custody form and other
forms and requires that all information related to determining
violations be retained for five years. Therefore, there is no
compelling need to maintain a separate longstanding record book.
Eliminating this requirement reduces the regulatory burden on licensees
and increases the efficiency of licensee drug testing programs (because
the time taken to enter information into the record book while the
testee waits is eliminated). The elimination of this requirement does
not preclude licensees from making their own determination of the
advantages of the use of a permanent record book and deciding to
continue to maintain one. A definition of ``limit of detection'' has
been added to support some of the several proposed changes intended to
cope with subversion of the testing process and to protect individuals
from incorrect allegations of such attempts.
Section 2.1 The Substances
The NRC proposes to amend this section to include return-to-duty
testing and to clarify that when a licensee tests for any illegal drug
during a for-cause test or analysis of a suspect specimen (currently
permitted by the rule), the licensee may consider any detected
[[Page 21120]]
drugs or metabolites (as currently authorized in section 2.7(d) of this
Appendix for samples suspected of adulteration or dilution). The NRC
deems it appropriate, in these particular instances, where reasonable
suspicion of an FFD problem exists, to allow close scrutiny at the
discretion of the licensee. The licensee continues to be responsible
for assuring that the results establish a valid basis for any action
taken.
The NRC has given consideration to adding additional substances to
the panel of drugs to be tested (e.g., benzodiazepines, barbiturates,
and/or LSD) but has chosen not to add substances at this time. In the
interests of developing and maintaining a coherent and well-organized
drug testing program, the NRC anticipates continuing to follow the lead
set by HHS in its guidelines. HHS reviews the panel of drugs from time
to time from a national perspective. At this time, the NRC prefers to
have any new additions to the minimum required drug panel dependent on
HHS first adding substances to its panel of drugs to be tested.
However, should the interest of public health and safety indicate a
need to add substances to the drug panel, the NRC will take
appropriate, timely action. The NRC continues to expect a licensee to
consider any localized patterns of substance abuse when designing its
FFD program, as required by Sec. 26.24(c).
Section 2.2 General Administration of Testing
Section 2.2(a) would be amended to clarify that licensees may
dispose of chain-of-custody forms associated with FFD policy violations
after 5 years and need not retain chain-of-custody forms recording no
FFD violations or other anomalies after appropriate summary information
has been recorded for program administration purposes. Licensees
recently pointed out that current rule does not permit destruction of
these records and that they have started to accumulate an appreciable
volume of files. The retention of records for 5 years following
termination of unescorted access would provide appropriate records for
responding to background investigation inquiries while reducing the
storage burden on licensees. Proposed modifications to section
2.2(d)(4) would clarify that the optional blood test for alcohol misuse
is intended for use in a subsequent appeal of a confirmed positive
alcohol test. By asking for a blood test, the individual is asking for
information that can be used to appeal a licensee's determination of an
FFD policy violation.
Section 2.3 Preventing Subversion of Testing
The proposed amendments to this section would clarify the
individuals for whom appropriate background checks and psychological
evaluations are required and would reduce the required frequency for
those activities from every three years to every five years. These
changes were made in response to licensee experience and for
consistency with generally accepted security practices for
reinvestigations into reliability and trustworthiness. This section
also contains clarifications that would conform with proposed revisions
to Sec. 26.2 that would clarify the Commission's original intent that
FFD program personnel responsible for the administration of testing
would meet the highest standards for honesty and integrity and be under
the drug and alcohol testing requirements of the rule. These additions
specify that testing of FFD program personnel shall, to the extent
practicable, be done by personnel independent of the FFD program.
Rather than describe in the rule how this requirement should be
implemented, the NRC recommends that the random selection process,
specimen collection, and testing services could be considered for
performance by licensee employees specifically qualified for these
infrequent duties, persons under contract to meet this requirement, or
an exchange of services arranged among sites or utilities in the same
geographical area. Alternatively, if a licensee maintains FFD programs
both on site and at corporate headquarters, the FFD personnel who
administer the program at headquarters could administer the testing of
on-site FFD personnel and vice versa.
This requirement is intended to reduce the possibility of FFD
program personnel being responsible for testing themselves or their
close colleagues. Unless otherwise specifically covered by the rule,
personnel selected to test FFD program personnel would be independent
of the administration of the FFD program to the extent practicable.
Section 2.4 Specimen Collection Procedures
The NRC proposes a number of changes in this section to increase
the clarity and consistency in the wording of the rule. In addition to
minor editorial changes, the NRC proposes to clarify that there is no
requirement for the courier's signature to be included on the chain-of-
custody form (Sec. 2.4(d)). Because specimens are sealed in packages
that would indicate any tampering during transit to the laboratory, and
couriers, express carriers, and postal service personnel do not have
access to the custody and control forms, there is no need for such
personnel to document the chain of custody for the package during
transit. This is in keeping with standard forensic laboratory
procedures and would streamline the specimen transportation process.
This is also consistent with a recent revision to the HHS guidelines.
In regard to suggestions that the NRC specify actions to be taken
if there is a break in the chain of custody, the NRC is aware that the
Department of Transportation and HHS have published guidance that
addresses the proper handling of breaches in the chain of custody in
the transportation industries. The NRC believes this type of guidance
is not necessary in the rule but expects that licensees would take
action to discover and correct problems with the custody and control of
specimens. Licensees should be aware that, when actual breaks in a
specimen's chain of custody are detected and confirmed, the test result
associated with that specimen must be invalidated. The NRC notes that
judicial rulings indicate that minor ``administrative'' problems should
not be considered breaks in the chain of custody. Examples include
failure to include a middle initial or one digit of a social security
number being incorrect, which are among the many techniques used in
attempts by individuals to invalidate tests. Another ``administrative''
example found by the courts not to be a break in the chain is the
collector and donor leaving a sealed specimen bottle unattended for
approximately 1 minute with reasonable measures in place to conclude
that no person had access during that period. This should not be
interpreted to mean that the courts will accept sloppy collection
procedures. The Commission expects that licensees will be sufficiently
diligent and attentive to detail in this matter. The NRC would also
note that licensees that test urine specimens for the five drugs
specified in Appendix A to Part 26 at the specified concentration
levels can use the OMB-approved Federal Drug Testing (chain-of-custody)
Form (OMB Number 9999-0023) developed by the Department of
Transportation and HHS and published in the Federal Register on August
19, 1994 (59 FR 42996). Licensees that test for additional drugs or use
cutoff levels different than established by HHS in its laboratory
certification program may not use the OMB approved form, but should use
a ``look alike'' form.
That the collection site person shall note on the chain-of-custody
form any
[[Page 21121]]
unusual behavior or appearance of a person being tested remains a
requirement of Section 2.4(g)(9). The NRC has noted and considered the
privacy considerations associated with this requirement and continues
to believe that the need to take note of such behavior or appearance is
an appropriate part of the testing process. Clarification to Section
2.4(f) would assure that a specimen of questionable validity would
constitute a reason to believe the individual may alter or substitute a
specimen.
In accordance with HHS Guidelines, the NRC proposes to eliminate
the directive that tested individuals be provided an opportunity to set
forth on the chain-of-custody form information concerning medications
taken or administered in the past 30 days (Section 2.4(g)(4)). The
availability of such information does not eliminate the need to do a
confirmatory test on an unconfirmed positive screen test result. This
information becomes useful only at the point at which the MRO reviews a
confirmed positive test result. It is at this stage, when this
information can be conveyed by the tested individual directly and
confidentially to the MRO, that information about medications the
person may be using or has used becomes germane to determining whether
a fitness-for-duty policy violation has occurred. Eliminating the
opportunity for the tested individual to provide this information on
the chain-of-custody form would enhance the individual's privacy
interests by precluding the chance of any testing program or licensee
personnel other than the MRO learning of the individual's use of
medication.
The NRC proposes to amend Section 2.4(g)(10) to allow licensees to
have an individual, other than a collection site person, accompany an
individual into a rest room not in the designated collection site if
the designated collection site is inaccessible. The NRC also proposes
to amend Sections 2.4(g)(15) and 2.4(g)(24) to allow licensees to have
an individual, other than a collection site person, observe the
collection of a specimen whenever there is reason to believe the
individual may have altered or substituted the specimen. However, the
requirement that the individual be of the same gender as the employee
still exists. This proposed change is based on NRC's belief that it not
always possible, under all circumstances, to have a collection site
person of the same gender available. These revisions are consistent
with the June 1994 changes to the HHS guidelines.
The NRC proposes reducing the required urine specimen quantity from
60 milliliters (ml) to 30 ml for the primary specimen and, when split
specimens are collected, to require the collection of an additional 15
ml (Section 2.4(g)(11)). This change conforms with recent revisions to
the HHS guidelines. Because some licensees conduct on-site testing and
test for additional drugs, they may need to collect an additional
volume to meet these needs. The NRC understands that laboratories
require only a few milliliters for testing and that a 30 ml sample is
sufficient in volume for both immediate testing and for the retention
of a second aliquot for further testing, if necessary. The NRC also
understands that accurate measurement of specimen temperature is
difficult with a small volume but does not believe that ``partial''
specimens should be disposed of and not tested. Reported experience in
other industries indicates that the consumption of water by those
unable to give a urine specimen should be limited to one 8-ounce glass
of water every 30 minutes but not to exceed a maximum of 24 ounces.
This rate would protect the health of individuals who are providing
specimens and is consistent with the recent revision to the HHS
guidelines.
The NRC proposes changes to the collection procedures to ensure
that a urine specimen is not adulterated or diluted and to detect
surrogate samples being submitted. Licensees have reported several
examples of specimens being adulterated or diluted and surrogate
samples being submitted. This experience is consistent with that of
other workplace programs discussed at HHS's Drug Testing Advisory Board
meetings. These recommended changes reflect the NRC's desire to
minimize the vulnerabilities in the collection and testing of urine
specimens that substance abusers have exploited. In addition to
limiting the time between notification and collection recommended in
Sec. 26.24(e), the first proposed change in the collection procedure in
Section 2.4(g) would provide clearer guidance that an observation of a
urine specimen for color and clarity be used to identify only obvious
signs of adulteration (Section 2.4(g)(14)). Urine color and clarity are
affected by a wide range of physiological changes including an
individual's health, level of hydration, medications, and diet. Test
personnel should therefore use observation of color and clarity of the
specimen only for gross signs of adulteration. These may include
crystals settled in the bottom of the container, off-colors such as
blue or green, and an excess of bubbles when the container is shaken.
The second proposed change (Sections 2.4(g)(13) and 2.4(g)(15)) would
establish a narrower temperature band for acceptable urine specimens,
with a minimum temperature of not less than 34 deg.C/94 deg.F (now
specified in whole numbers in accordance with HHS guidelines). This
should make attempts to submit surrogate samples more difficult and,
together with other changes, would be consistent with practices by a
few licensees that have produced good results. The third proposed
change would allow licensees to set their own parameters, within the
range set by the rule, of the accepted urine temperature range. This
increased flexibility recognizes that there are a number of acceptable
options for recording temperature and that each allows different
minimum and maximum acceptable readings. For example, some temperature
recording devices are located in the specimen container and record a
``peak'' temperature immediately. The temperature that is expected to
be recorded by this device is close to core body temperature--a
temperature that could occasionally require a second specimen under
direct observation under the current rule. The current temperature
requirement is based on a method that records the temperature several
minutes after the specimen leaves the body. The range of temperatures
(i.e., the spread between the minimum and maximum acceptable
temperatures) must be limited as specified in the rule. The type of
temperature reading device, and the acceptable range of temperature for
that device, must be specified in the licensee's procedures. Two other
proposed changes would reduce the likelihood of undetected tampering by
requiring secure sealing of specimen bottles and, in accordance with
HHS guidelines, shipment in tamper evident containers.
The NRC proposes two changes in this section with regard to testing
for alcohol (Section 2.4(g)(18)). First, the NRC proposes to remove the
requirement that the worker undergo a second breath test for alcohol
when the first test is essentially zero (less than 0.01 BAC). The
licensee may, at its discretion, collect and measure the breath a
second time. This change reduces the impact on individuals being tested
and on the licensee by reducing the amount of time taken by the testing
process. It has been determined that a second negative test result is
not
[[Page 21122]]
technically necessary. Second, the NRC recognizes that alcohol is
metabolized relatively quickly (nominally 0.015 percent BAC per hour)
and proposes to make explicit that the length of time between a
confirmed positive breath test for alcohol and the drawing of a blood
specimen to test for purposes of appeal must be minimized. This
proposed amendment would require that the interpretation of the results
of such a test must consider the time elapsed between the confirmed
positive breath test and the drawing of blood for use in an appeal
process.
Section 2.4(g)(24) [formerly (25)] would be revised to provide
flexibility in internal reporting and actions when an individual fails
to cooperate.
The NRC proposes making various revisions to the requirements for
specimen preparation and transportation to the HHS-certified laboratory
or to the licensee's testing facility to decrease the chance that
specimens will be degraded between the time they are collected and the
time they are screened and confirmation tested (Section 2.4 (i)).
Reports from several licensees have suggested that specimen degradation
during shipment has been the cause of ``false negative'' test results.
The NRC has been advised that specimens not kept chilled during storage
or transit may have become contaminated because of the buildup of
bacteria and their wastes to an extent sufficient to possibly alter
laboratory test results. Information on this phenomenon is limited and
there are conflicting opinions regarding the seriousness of the
problem. For example, one MRO stated that 19 of 21 on-site screening
test positives were not confirmed because of degradation of the samples
during shipment. (See Appendix B to NUREG/CR-5784.) Also, the reasons
for unsatisfactory results of blind performance tests reported by the
HHS-certified laboratories are that the blind specimens degraded below
the cutoff levels or that the specimen containers adsorbed some of the
drugs or metabolites. Therefore, the NRC has conducted pilot tests to
gain additional insight on whether specimen degradation was a problem.
These pilot tests detected a significant level of cocaine metabolite
deterioration when urine specimens with a high relative acidity/
alkalinity (pH) level were stored at relatively high temperatures
(i.e., 100 deg.F) for 36 hours or more. A modest study by one licensee
showed a definite decrease in the concentration levels of THC in
specimen bottles stored at room temperature for one week (e.g., from
199 to 178 ng/mL); where the specimen was allowed to touch the inside
of the cap sealer, the concentration was reduced more than one half
(e.g., from 199 to 77.8 ng/mL). The NRC specifically invites comments
regarding the proposed revisions concerning specimen degradation and
whether rule changes should be made or the information published in
report form for voluntary use. In particular, the NRC is interested in
data that licensees conducting on-site testing could provide. Of
specific interest would be examples of on-site unconfirmed positives
that had degraded during shipment. Licensees or other parties
submitting such information should include any known factors, such as
temperatures and duration of exposure to the suspect condition, that
may have contributed to the problem.
At this time, the NRC proposes two specific revisions intended to
address this specimen degradation problem. The first revision would
continue to require that urine specimens be shipped to the HHS-
certified laboratory within six hours of collection or cooled to not
more than six degrees centigrade pending shipment (as previously
required by 2.7(c)). The second revision would require that the time
between specimen shipment and receipt of the specimen at the HHS-
certified laboratory not exceed 48 hours, or that the time between
shipment and the screening test at the HHS-certified laboratory not
exceed 72 hours.
The NRC proposes several other minor editorial revisions to Section
2.4 in response to industry experience. These revisions do not
substantially alter the intent of the original rule. Changes to Section
2.4(i) would simplify the tracking system for the courier and the
laboratory. The NRC proposes that collection personnel should report
incidents when an individual refuses to cooperate in the testing
process to an appropriate authority (Section 2.4(j)), as designated by
the licensee, rather than through the MRO to appropriate management.
The NRC believes the MRO need not be a key player because refusals to
cooperate are administrative concerns rather than medical problems.
Section 2.6 Licensee Testing Facility Personnel
A change conforming to the HHS guidelines is proposed to assure
that training of licensee testing facility managers includes
maintenance of chain-of-custody.
Section 2.7 Laboratory and Testing Facility Analysis Procedures
Proposed revisions to this section further clarify wording and
procedures discussed in previous sections.
The NRC proposes several changes in this section that would be
consistent with the recent revisions to the HHS guidelines. The NRC
proposes to reduce the screening cutoff level for marijuana from 100
nanograms per milliliter (ng/ml) to 50 ng/ml (Section 2.7(f) formerly
2.7(e)). Current testing technology is capable of supporting reliable
and valid results at this level. In addition, analysis of results in
nuclear industry drug testing programs shows that positive test rates
(indicating increased detection) increased substantially when the
screening level was lowered to 50 ng/ml from 100 ng/ml. These proposed
changes would make the NRC's FFD rule consistent with the HHS
Guidelines (59 FR 29908; June 9, 1994) and the cutoff levels used by
all other Federal agencies. This change is needed to ensure that
licensees' specimens are tested by a process certified by HHS (any
cutoff level different than the HHS-certified process must be
accompanied by appropriate QA measures). The NRC proposes a revision to
eliminate the requirement that test results be reported in batches
(Section 2.7(h)(1)). In addition to being consistent with the recent
revisions to the HHS guidelines and the current general practice, this
would significantly decrease the amount of time required for licensees
to receive certain types of test results from the laboratory.
The NRC proposes to clarify its original intent that licensees
which retain split specimens must use a different HHS-certified
laboratory in cases where a split specimen is being tested for an
appeal (Sec. 2.7(k)). The NRC was informed by HHS that requiring a
different laboratory essentially guarantees a different process for
preparing the specimen which would provide a high assurance of
detection of any laboratory error or inaccuracy of test results. In one
instance, the same laboratory that produced a positive test retested
the specimen during an appeal and, using the same method, made the same
mistake and produced a second false positive test. The false positive
was discovered in response to repeated appeals by comparing this
laboratory's results with the results reported by another laboratory.
Although suspected false positives have been extremely rare, this
proposed revision would further reduce the possibility for recurrence
of a false positive due to a laboratory error.
[[Page 21123]]
The NRC is proposing a number of revisions to this section aimed at
enhancing the effectiveness and reliability of licensee FFD program by
requiring testing to determine the validity of specimens; this
adaptation of a recent change to the HHS guidelines would detect
evidence of adulteration or dilution, thereby reducing the potential
for subversion of the testing process. This change would also address
concerns that the rule does not require the laboratories to report the
results of tests, such as pH, specific gravity (SG), and creatinine, to
the extent these tests are performed. Licensees have encountered
various practices, such as adulteration and dilution, by substance
abusers to avoid detection and the NRC desires to minimize the
vulnerabilities in the testing process that have been exploited. One of
these measures would be to determine specimen validity. Licensees
conducting onsite testing would be required to determine the validity
of all specimens collected; this would avoid disposal of specimens that
would have been determined invalid by the laboratory. The validity of
the specimens would be determined through the addition of testing for
specific gravity on arrival of the specimens at the licensee's onsite
testing facility or the HHS-certified laboratory (Section 2.7(e)). The
NRC requests comments on whether these tests for determining specimen
validity should include tests for acidity/alkalinity (pH), creatinine,
and other tests for adulterants and whether these tests should be
conducted as part of the collection process so that a second specimen
can be collected immediately and under direct observation. To protect
those being tested from incorrect conclusions about the validity of a
specimen, the NRC is proposing that those specimens determined to be
outside of specification would be subjected to both screening and
confirmation tests at the limit of detection that the laboratory is
capable of performing. The NRC understands that this may not be
technically feasible for specimens containing some adulterants. In
those cases, the laboratory would not test to limit of detection (LOD)
and would report the specimen condition. The NRC understands that some
HHS-certified laboratories have an LOD much lower than the established
cutoff values, while others may not be able to achieve an LOD less than
40 percent of established cut off levels. Therefore, the NRC requests
comments on the desirability of requiring that tests of specimens which
are outside of specifications (i.e., show evidence of adulteration or
dilution) be performed at the HHS-certified laboratory's LOD and
depending on licensees to select laboratories capable of achieving the
lower LODs and to develop appropriate quality controls. Recognizing the
ability of HHS-certified laboratories to identify drug metabolites at
lower concentration levels found in dilute specimens in a forensically
sound manner, the NRC believes this is an appropriate approach to
reducing the potential for incorrect conclusions about the validity of
a specimen.
The NRC believes that the information developed during these
procedures would enable the MRO to make an accurate determination of
whether a specimen of questionable validity has actually been
adulterated or diluted. If the specimen has been heavily adulterated or
diluted, specimen validity test results would indicate an obvious
attempt to subvert the testing process. If the specimen is moderately
diluted, with no drugs detected, and the worker's health habits reveal
consumption of appropriate quantities of liquids, the MRO would
determine no attempt to subvert the testing process. If drugs are
detected, the MRO would conclude that the worker has attempted to
subvert the testing process.
In keeping with this proposed change to reduce subversion of the
testing process, the NRC proposes to require (in Section 2.7(d)) that
the Medical Review Officer report any adulteration or dilution evidence
(excluding hydration resulting from an acceptable reason) to licensee
management in order to enable licensee management to more vigorously
pursue subversion attempts (Section 2.7(h)(1), formerly Section
2.7(g)(1)). Hydration resulting from acceptable reasons (e.g., drinking
fluids for health reasons) would be excluded because this type of
hydration occurs frequently, especially in warm climates. Another
revision would add urine specimens that are determined on site to be
questionable for adulteration or dilution to those specimens that
licensees must ship to an HHS-certified laboratory for testing (Section
2.7(d)). By a related revision, all specimens that have been
adulterated or diluted, or that the licensee specifies have been
associated with personnel actions for other reasons, would be subject
to long-term frozen storage for at least one year by HHS-certified
laboratories (Section 2.7(i)). The NRC recognizes that these changes
are minor clarifications or modifications to existing requirements and
understands that many licensees are currently performing these proposed
actions.
The NRC proposes four changes to the requirements for testing.
First, the NRC proposes that a test for d (dextro) and l (levo) isomers
of methamphetamine be required for all positive tests for amphetamines
(an additional two days are provided the laboratory for processing
specimens suspected of containing amphetamines) (Section 2.7(g)(6)).
Some legal drugs (e.g., Vicks inhaler) contain amphetamine compounds
that may yield a laboratory-confirmed positive for amphetamine use.
Laboratory confirmatory tests for the d and l isomers are able to
differentiate between compounds and to identify those positive test
results that are the result of legal use. Many licensees have already
been using this test as further confirmation of positive test results
for amphetamines. This proposed revision would mandate the use of this
test by all licensees and be consistent with current laboratory
practice described by HHS in its Technical Advisory of March 11, 1991.
Second, a new Section 2.7(f)(3) would permit multiple screening tests
only in certain limited situations. This would adopt with some
modification a 1994 change HHS made to its guidelines which is intended
to be limited to amphetamines to reduce the effect of possible cross
reactivity due to structural analogs, and to unique testing problems.
However, a few licensees have expressed concern when they learned their
laboratory was routinely using multiple screening tests on all
specimens. Multiple screening tests should not be used on a routine
basis because of the increased number of false negative test results
that could occur. Third, the NRC is also proposing to reduce the time
that licensees must wait for laboratories to provide testing results
and, thereby, enable licensees to grant unescorted access to new
employees and to conclude activities related to drug testing in a more
timely manner (Section 2.7(h)(1)). It is the NRC staff's understanding
that most HHS certified laboratories can, and usually do, report
negative results to the licensee within 24 hours of receipt of
specimens. A laboratory-confirmed positive result usually requires
another 24 to 48 hours. Exceptions are when a positive test result for
amphetamine requires further testing for d and l isomers or an opiate
positive requires further testing for 6-acetylmorphine (6-AM) at a few
laboratories. The reduced period of time provided to laboratories to
report results assures that licensees will receive results in a timely
manner and will reduce the time that new employees will have to wait
for their unescorted
[[Page 21124]]
access, thereby reducing costs to the licensee. Fourth, the NRC
proposes to require that a methamphetamine confirmatory test result
contain at least 200 ng/ml of amphetamine for the result to be reported
as a laboratory positive (Section 2.7(g)). This revision would conform
with a similar change made to the HHS Guidelines on June 9, 1994 (59 FR
29908). This requirement was adopted by HHS to prevent false positive
methamphetamine results that can be caused by chromatographic
resolution problems in the confirmatory testing process.
In a related matter, the NRC understands that a significant
percentage of laboratory-confirmed positives for opiates are determined
to be negative by the MROs based on use of prescription medication,
poppy seed consumption, no clinical evidence, or other reasons. In
several public meetings, MROs and other FFD program personnel have
expressed concern that the current opiate testing levels are not
properly targeting opiate abusers. The concern is that the program is
not effective in deterring or detecting heroin use (the rule requires
clinical signs of abuse for the MRO to determine the test result as
positive, yet heroin is frequently smoked or inhaled leaving no
clinical signs of abuse), and large numbers of laboratory confirmed
positives for opiates are determined negative, which imposes an
unnecessary burden on the MROs and costs to the licensees. Data from
eight licensees summarized in Table 3.12 of NUREG/CR 5784 indicate that
only 2 of 124 laboratory-confirmed opiate positives were confirmed by
MROs as positive (both of these positive results were reported by one
licensee). These data are consistent with anecdotal reports from HHS
and DOT officials and MROs.
The NRC understands that the Department of Defense (DOD) has raised
its screening test cutoff level for opiates to 2,000 ng/ml and the
confirmatory test cutoff levels for morphine to 4,000 ng/ml, codeine to
2,000 ng/ml, and 6-AM (a metabolite specific for heroin) to 10 ng/ml.
The NRC is specifically interested in public comments and
supporting data as to whether it should raise the cutoff levels for
screening and confirmation tests for opiates. Should the NRC set its
levels consistent with those set by the DOD and proposed by HHS on
November 16, 1995 ( 60 FR 57587)? Given the level of concern for safety
in the nuclear industry, should the NRC retain the current levels?
Two revisions related to the short-term refrigerated storage of
specimens are also being proposed (Section 2.7(c)). This section
currently requires that specimens that do not receive a screening test
within seven days of arrival at the HHS-certified laboratory be chilled
in secure refrigeration units. The NRC has determined through pilot
experiments that at least one drug metabolite is subject to
deterioration if a urine specimen containing this metabolite is allowed
to stand for more than 32 hours at relatively high temperatures. The
NRC has also become aware of anecdotal evidence that indicates that,
when specimens are shipped or stored at warm temperatures, there is a
potential for drug or metabolite deterioration such that specimens
containing drugs or metabolites over the cutoff level at the time they
were submitted can be found to be negative in either screening or later
confirmatory tests. The NRC is, therefore, proposing to require that
specimens that will not receive a screening test and, if appropriate, a
confirmatory test within one day of arrival at the HHS-certified
laboratory be stored in a chilled condition until tested.
The NRC proposes several modifications that would clarify or modify
requirements in light of industry experience. These modifications do
not significantly affect the rule's original intent and are intended to
reduce unnecessary problems in the implementation of the rule. First,
Sections 2.7 (f)(1) and (g)(2), formerly Sections 2.7(e)(1) and (f)(2),
would be modified to clarify that licensees using lower cutoff levels
are not required to perform two different tests at different cutoff
levels. Instead, they are expected to use extrapolation techniques to
provide the required estimates of the number of positive test results
from HHS-certified laboratories that would have occurred using the NRC
cutoff level. Second, the NRC proposes to delete the requirement that
licensees have emergency power equipment available for refrigeration
units in the event of a power outage (Section 2.7(c)). Instead, the
proposed revision would require only that licensees have some kind of
contingency measures available to maintain specimens in a chilled
state. Third, the NRC proposes to allow routine administrative tasks
now assigned to the MRO to be performed by the administrative staff of
the MRO (Section 2.7(h)(2)), formerly Section 2.7(g)(2). Licensee
experience has found that the duties of the MRO are extensive and that
many of the duties prescribed in the rule could be performed equally
well by the MRO's staff without compromising the privacy of
individuals. Fourth, the NRC proposes to make explicit that licensee
contracts with HHS-certified laboratories provide that the licensee and
the NRC should be able to obtain from the laboratory all information
and documentation that is reasonably necessary for the licensee's
inspection or audit of the laboratory, including, but not limited to,
copies of the laboratory's HHS certification results (Section 2.7(n),
formerly Section 2.7(m)). In addition, this revision provides for
reduced licensee inspection activities in those areas currently
inspected under the HHS certification program. Fifth, the NRC proposes
to add to Section 2.7(n) a provision that would permit, in the event
that a licensee's HHS-certified laboratory loses its certification, the
licensee to use for up to 3 months an HHS-certified laboratory that has
been audited by another NRC licensee that shares the same drug testing
and cutoff standards. In such cases, the licensee would be required to
audit the newly contracted laboratory within three months. Sixth, the
NRC proposes to revise Section 2.7(h)(5) (formerly Section 2.7(g)(5))
to clarify that the laboratories, which are now required to provide
expert testimony covering drug test results, would retain the originals
of the specimen chain-of-custody form in order to assure that evidence
is available for appeals. The documents would be retained by the
laboratory consistent with the proposed retention requirements in
Section 2.2(a) of the Appendix. Seventh, the NRC proposes to clarify
the original intent of Section 2.7(k) (formerly Section 2.7(j)) with
regard to the applicability of the quantification of test results to
split specimens. In a related matter, the NRC considered but decided
not to adopt a change to Section 2.7(h)(3) to further clarify that the
laboratory must provide quantitation of test results to the MRO when
requested. Some laboratories have been reluctant to provide such
requested information. Eighth, the NRC proposes to clarify that the
individual must be informed of his/her option to test the split sample
(Section 2.7(k)). Inspections have indicated that, for various reasons,
not all individuals are so informed. Ninth, the NRC proposes to make
explicit that all standards used to calibrate alcohol breath analysis
equipment and equipment used at licensees' testing facilities for
conducting screening tests must be current and valid for their purpose
(Section 2.7(p)(2), formerly Section 2.7(o)(2)). The NRC has received
comments from licensees regarding the receipt of out-of-date
calibration standards for alcohol breath analysis
[[Page 21125]]
and regarding the inability of some screening test equipment to test at
required levels. The NRC is also aware of the deliberate use of expired
calibration standards.
The NRC also proposes to revise Section 2.7(k) by requiring an
individual's request that his or her split specimen be tested in a
timely manner. Current wording of the rule does not establish a time
limit for an individual to request a test of a split specimen. The
proposed revision would permit licensees to establish a definition of
``timely,'' but it could not be restricted to less than 72 hours from
the time the individual is notified of the violation. Although recently
revised HHS guidelines established a maximum time limit of 72 hours,
the NRC believes licensees should be provided the flexibility to
determine appropriate time limits for split specimen testing requests
that meet particular demands associated with the licensee's
notification experience (e.g., notification of result occurring just
before a long holiday period or the individual out sick). This revision
would also ensure that individuals' rights are protected by
establishing the minimum 72 hour period within which they may make a
request for split specimen analysis.
A proposed revision to Section 2.7(p)(3) (formerly Section
2.7(o)(3)) would allow use of alcohol breath analysis equipment that
conforms to the September 17, 1993, amendments to the National Highway
Traffic Safety Administration's (NHTSA) Model Specifications for
evidential breath testing devices originally published in 1984. While
these amendments reflect new lower evaluation thresholds for devices to
measure breath alcohol, licensees need not acquire new devices that
meet these amended standards. Breath analysis equipment that meets the
1984 NHTSA standards will continue to be acceptable in NRC FFD
programs.
The NRC considered a potential revision to test for agents used to
mask the presence of THC and other drugs. An analysis of specimens
producing negative screening tests to assure that they do not contain
agents that mask the presence of THC and other drugs could be specified
by rule. Products that can be added to urine as masking agents are
currently available and tests for these products are currently used by
some laboratories. Testing for these products would increase the
detection of attempts at subverting the testing process. While it has
decided not to propose this revision at this time, the NRC invites
public comment on both the need for and the resource impact of such a
requirement.
The NRC has received requests from several licensees and vendors to
permit the on-site use of non-instrumented qualitative immunoassay
methods that involve the use of inexpensive, disposable devices.
Convenience and speed in obtaining results appear to be the main
advantages of these devices. Such testing does not use laboratory
analysis techniques, can be performed quickly, and can produce
virtually immediate results. These compact and portable testing devices
show promise as a quick and easy method for testing in certain
circumstances such as physician's diagnostic needs when the presence of
drugs or alcohol can affect what treatment is suitable for emergency-
room patients. These testing devices may also be well adapted to some
criminal justice applications, roadside testing, or testing in remote
locations. They are generally able to identify the five drugs or drug
metabolites of concern to the NRC.
While Part 26 does not currently preclude the use of such non-
instrumented devices for screening tests, the NRC is aware that there
are several technical variables involved in the use of these devices
that may prevent them from achieving the high levels of specificity,
accuracy, and repeatability demanded in licensees' FFD drug testing
programs. Temperature and barometric pressure can alter the amount of
urine being tested and the repeatability of the test. Temperature
variations may affect the reactivity of the chemical reagents and
indicator strips being used. These effects alter the amount of urine
being tested and the repeatability of the test. The NRC's concern is
whether these types of technical variations will have sufficient impact
to alter the specificity, accuracy, and repeatability of the test
results. The NRC is concerned that the use of such devices may lead to
a number of false negative screening test results. (The concern for
false positive screening test results is minimal since all positively
screened specimens must be tested at an HHS-certified laboratory and
any positive results from the laboratory followed by a review of the
results by an MRO.) The Commission believes that the use of testing
devices that might increase the number of false negative screening test
results is not consistent with the goals of FFD testing or to the
credibility of the program to those subject to testing.
The NRC is also concerned that there are not sufficient procedural
safeguards currently in place that would ensure reliably accurate
screening test results if these non-instrumented devices were to be
used by licensees. There are, for example, no quality control
procedures known to the Commission that could be used to validate the
results produced by the use of these devices, nor is there any
mechanism in place to validate industry-wide results over time. For
example, accurate tests at the beginning and end of a batch of
specimens tested with an instrumented test would indicate all specimens
in the batch were accurately tested. On the other hand, ``batch''
testing with these non-instrumented devices is probably not feasible.
Likewise, the potential for subversion that could be introduced by the
use of these devices has not yet been adequately investigated or
addressed. Requirements may need to be developed to protect an
employee's right to privacy and to minimize the chances for subversion
of the testing process. No procedural safeguards exist in the text of
the rule or in Appendix A that would address opportunities for
subversion of the testing process which may be created by the use of
these new devices.
Given the uncertainties surrounding the potential use of non-
instrumented testing devices, the NRC would prefer that these devices
not be used for screening tests in licensees' FFD programs at this
time. The NRC is aware that HHS has been mandated to investigate the
accuracy and reliability of these devices. The NRC will monitor the HHS
investigation and continue to pursue its own inquiry into the
feasibility of the use of these devices for FFD screening tests. As
part of this effort, the NRC will determine whether new guidelines,
quality assurance procedures, and performance standards that would
govern their use should be added to Part 26.
To aid in this effort, the NRC invites public comment on the
advisability of its creating guidelines, procedures, or standards for
non-instrumented testing devices. The NRC would welcome specific
recommendations as to how Part 26 could be amended or other means that
would address the concerns discussed above and other issues surrounding
the use of such devices. Alternatively, the NRC invites public comment
on the advisability of its waiting until procedures or standards
governing the use of non-instrumented testing devices are developed by
other agencies and then evaluating and adapting those standards to the
nuclear power industry's requirements. Should there be a Conforming
Products List for these devices similar to that published by the NHTSA
for evidential breath measurement devices, and who should administer
such a program? The NRC
[[Page 21126]]
also would be interested in learning under what conditions, if any,
would the use of non-instrumented drug testing devices produce cost
savings as compared to licensees' current means of screening.
The NRC notes that Section 2.7(h)(4) (formerly Section 2.7(g)(4))
requires that HHS-certified laboratories transmit drug test results to
MROs in a manner designed to protect the confidentiality of that
information. In order to promote the efficient administration of FFD
programs, it is the Commission's policy that FFD program personnel can
assist MROs in the receipt and processing of the laboratory reports.
While some programs have chosen to require that test results be
received only by their MROs, others have allowed other program
personnel under the supervision of an MRO to receive the results and
forward them to the MRO. The NRC believes that both approaches are
acceptable as long as the procedures for receiving and handling test
results within the program are designed to preserve the confidentiality
of the test results and actually accomplish that purpose. The NRC
reiterates that a test result reported as a confirmed positive by an
HHS-certified laboratory must not be considered a violation of a
licensee's FFD policy until such result is reviewed by the MRO to
determine if it constitutes evidence of such a violation. Therefore,
the procedures through which the MROs receive test results from HHS-
certified laboratories should contain explicit safeguards against
improper disclosure of the report and premature actions such as the
laboratory-confirmed test result being recorded in the employee's
personnel file, an employment action being taken, or licensee
management being notified of the positive result until after the MRO
has determined that there is not an acceptable medical explanation for
the positive result.
Section 2.8 Quality Assurance and Quality Control
A proposed revision to Section 2.8(b) would clarify that the
current requirement that licensee testing facilities ``process'' blind
performance specimens means that licensees conducting on-site testing
must perform an immunoassay test on all such performance specimens
before they are submitted to the HHS-certified laboratory. This
revision is intended to make clearer the NRC's original intent
regarding this requirement. A further revision would make explicit the
requirement that licensees must evaluate the results of their HHS-
certified laboratory's testing of the blind performance test specimens
and a sampling of specimens screened as negative submitted by the
licensee and take corrective action as appropriate.
The NRC, after consulting with SAMHSA, proposes an adaptation of
recent changes to the HHS guidelines for blind performance test
specimens (Section 2.8(e)). As HHS did with its guidelines, the
modifications would reduce the percentage of blind performance
specimens, reduce the proportion of blind performance tests relative to
the total number of tests submitted, and reduce the maximum required
number of blind performance test specimens. These changes are intended
to ensure that the number of blind performance test specimens required
to be submitted are adequate to assure quality in the testing process
and particularly in the HHS-certified laboratory.
The NRC proposes to reduce the percentage of blind performance
tests from 50 percent to 20 percent for the initial 90-day period and
from 10 percent to 3 percent after the initial period, consistent with
changes made to the HHS guidelines and the Department of
Transportation's rules. The maximum number of blind performance test
specimens required to be submitted both in the initial 90-day period
and after is also lowered in the proposed revision. However, the NRC
believes a maximum number less than that established by the HHS
guidelines would assure adequate quality in the testing process.
Whereas HHS lowered the maximum number of blind specimens to be
submitted during the initial 90 day period from 500 samples to 200, the
NRC proposes a further reduction to 100 specimens. The maximum number
of specimens submitted thereafter during each quarter was reduced from
250 to 100 by HHS; NRC proposes a further reduction to 25 blind
specimens per quarter.
Because the NRC permits on-site testing and very few specimens with
unconfirmed positive test results would be submitted to laboratories at
these sites, the NRC, in consultation with SAMHSA, proposes that there
should be a minimum number of blind specimens (10 per quarter is
recommended) to ensure that a sufficient number are submitted to assure
the quality of the testing process.
The NRC intends that utilities with multiple collection sites
submitting specimens to the same HHS-certified laboratory meet the
percentage requirement for each collection site. However, a licensee
may combine the number of specimens collected from its multiple sites
to meet the total minimum requirement for all collection sites. That
is, if one or more of the utility's collection sites and the corporate
office contract with the same laboratory, they may pool their number of
regular test specimens to meet requirements for the minimum number of
blind performance test specimens. The NRC expects that blind specimens
will be submitted to the laboratories from each collection site and
that submission will be uniformly distributed throughout each quarter
to correspond with the submission rate for other specimens.
The NRC also proposes to lower the percentage of blind performance
test specimens which would be blank and raise the percentage which
would be positive for one or more drugs (Section 2.8(e)(3)). Increasing
the percentage of positive specimens would help offset the reduction in
the minimum percentage requirements for blind performance test
specimens and would assure that an adequate number of positive
performance tests for each drug are submitted for quality control.
Also, the NRC proposes that 10 percent of the positive blind specimens
be appropriately adulterated or diluted and ``spiked'' to 60 percent of
the cutoff value to challenge the laboratory's ability to determine
specimen validity as proposed in Section 2.7(e) of the Appendix.
The third proposed revision would clarify that licensees must
investigate any testing errors or unsatisfactory performance identified
throughout the testing process or during the appeals process (new
Section 2.8(f), formerly Section 2.8(e) (4), (5), and (6)). The NRC
intended, in the original rule, that testing or process errors
discovered in any part of the program, including the appeals 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 NRC also proposes to clarify Section 2.8(e)(2) by modifying the
reference to ``the initial 90-day period of any new drug testing
program'' to read ``the initial 90-day period of any contract with an
HHS-certified laboratory.'' The clarification would help assure that
intensified quality testing is performed during the initial phase of
testing by any new laboratory, as originally intended. (See previous
discussions in item number 10.5.6 of NUREG-1354 and item number 4.15 of
NUREG-1385.)
The NRC proposes revising Section 2.8(e)(1) by clarifying the
criteria that
[[Page 21127]]
licensees must follow when purchasing blind quality control specimens.
Currently requirements only ensure that blind quality control materials
be purchased from labs certified by HHS or a HHS-recognized
certification program. Due to the fact that not all suppliers of blind
quality control materials adhered to uniform standards for preparation
and certification, unacceptable blind quality control specimens have
been used. These unacceptable blind quality control test results, e.g.,
false negatives or false positives, lead to increased costs and lowered
efficiency because of additional tests and follow-up actions necessary
to validate the results of previously tested actual specimens. More
importantly, the unacceptable results may tend to cause loss of
confidence in the testing process. In order to eliminate these
problems, the NRC proposes to explicitly state the criteria, as HHS did
in its recent revisions to its guidelines, in order to clarify for
licensees the standards for blind quality control materials and make
the rule consistent with existing practice.
Section 2.9 Reporting and Review of Results
The NRC proposes a number of revisions to this section to clarify
the original intent of the rule.
Section 2.9(d) requires the MRO to determine if there is clinical
evidence of opiate abuse before verifying a test result to be positive
for that drug (meaning a clinical examination of all persons whose
specimen was reported by the laboratory as positive for morphine or
codeine). The NRC has become aware that some MROs believe that the
opportunity for an individual to discuss a positive test result and
related matters in a telephone conversation rather than at a face-to-
face interview is sufficient to comply with this section. Providing the
opportunity for only telephone conversations in some situations may not
be adequate, particularly in cases where opiate use is in question. FFD
experience demonstrates that personal, face-to-face, contact between
the MRO and the subject individual can play an important part in
arriving at fair and defensible judgments as to whether a violation of
FFD policy has occurred. This process will be further clarified in the
near future by HHS through revisions to its Medical Review Officer
Manual.
The NRC proposes to clarify that the standards applied to the
determination of whether clinical evidence of opiate abuse exists would
include a range of evidence, including substantial evidence of lack of
reliability and results inconsistent with ingestion of food or
medication. Some MROs have interpreted this section of the regulation
as restricting the types of evidence they should consider (Section
2.9(d)), in some cases resulting in ``pro forma'' rejection of all
laboratory positives for opiates.
With regard to legal drugs, the NRC proposes to remove the
requirement that Medical Review Officers determine whether there is
clinical evidence of unauthorized use of over-the-counter and
prescription drugs (Section 2.9(d)). This requirement has created
difficulties for Medical Review Officers because there is little
guidance that can be developed regarding what constitutes clinical
signs of abuse for these substances.
The NRC notes that during the first five years of program
operations, there has been programmatic inconsistency in MROs'
decisions concerning the abuse of legal drugs, such as the use of drugs
prescribed for one's spouse. This inconsistency has resulted in
significant variance in management actions taken in response to this
type of drug use. The NRC is not proposing a revision to this section.
Instead, the NRC expects MROs to use prudent judgment in dealing with
those situations which raise significant FFD concerns.
The NRC proposes clarifying that a medical determination of fitness
be conducted (Section 2.9(g)) in the following cases: (1) Where there
is a reason to believe that on-duty impairment may exist (whether or
not there is an FFD policy violation), (2) in the evaluation of all
for-cause tests results, (3) before making return-to-duty
recommendations, (4) before granting unescorted access to the protected
area when a record of a prior FFD violation exists, and (5) if a
history of substance abuse is otherwise identified. The licensed
physician or Medical Review Officer is to report to licensee management
both determinations of FFD violations and determinations of any
condition under which an individual may not be able to safely and
competently perform his or her duties. These requirements are intended
to increase assurance that a medical evaluation is performed for
circumstances where fitness may be questionable. The NRC wishes to
emphasize that the determination of an impairment problem that does not
constitute an FFD violation must not result in punitive action toward
the individual.
The NRC proposes to require Medical Review Officers to review BAC
readings between 0.02 percent and 0.04 percent and to extrapolate the
results of breath analysis for alcohol, or GC analysis of blood, back
in time when appropriate (Section 2.9(h)). This would ensure that
individuals who can reasonably be concluded to have had a BAC at or
above 0.04 percent while on duty will be found to be in violation of
the FFD policy.
The NRC proposes to revise Section 2.9(e) by clarifying what
constitutes a ``timely'' request by an individual that an aliquot be
reanalyzed. This would be an adaptation of the timeliness standard for
testing split specimens recently adopted in the HHS Guidelines.
However, under the HHS approach the split specimen ``belongs'' to the
donor and the primary specimen ``belongs'' to the employer; therefore,
the HHS guidelines are silent on timeliness for reanalysis of the
primary specimen. Current wording of this paragraph in the NRC's rule
requires an MRO to authorize a reanalysis of the original aliquot on
the timely request of the individual tested. This ambiguity could be
problematic for licensees who must determine how ``timely'' such a
request actually is. The proposed revision would permit licensees to
establish a definition of ``timely'', but it could not be restricted to
less than 72 hours from the time the individual is notified of the
violation. The NRC believes licensees should be provided the
flexibility to determine appropriate time limits for requests for
retesting specimens that meet particular demands associated with the
notification of the worker (e.g., notification occurring just before a
long holiday period or extended illness), yet this revision would also
ensure that individuals' rights are protected by affording them a
minimum of 72 hours within which they may make a request for reanalysis
of the specimen. In addition, the NRC is allowing licensees the
flexibility to dispose of test results, based on scientific
insufficiency, after three years.
The NRC proposes adding a new Section 2.7(p)(6) and amending
Section 2.9(b) by restricting the types of arrangements that can exist
between the MRO and the HHS-certified laboratory or the operating
contractor of an on-site testing facility. The NRC proposes to require
that the MRO not be an employee, an agent of, or have any financial
interest in the laboratory or on-site testing facility operator for
which the MRO is reviewing drug testing results. Similarly, the
laboratory and on-site testing facility operator shall not have any
relationship with the MRO that may be construed as a conflict of
interest. These restrictions are consistent with recent changes to the
[[Page 21128]]
HHS guidelines and the NRC believes that they will assist in
eliminating any conflict of interest between the MRO and the contract
laboratory and on-site testing facility operator that may affect the
impartiality and objectivity of the MRO in reporting testing
deficiencies or errors to licensee.
Section 3.2 Individual Access to Test and Laboratory Certification
Results
The NRC proposes to delete this section and incorporate relevant
portions of it as Section 26.29(c).
Section 4.1 Use of HHS-Certified Laboratories
The NRC proposes to add a caution, upon the advice of SAMHSA, that
the HHS certification process applies only to the drugs and cutoff
levels specified by HHS and that the defensibility of the results of
tests at more stringent cutoff levels than those required under HHS
guidelines, for analyses of blood specimens for alcohol, and tests for
substances other than the 5 covered under HHS guidelines depends on
appropriate measures by licensees to assure that the reported results
are valid.
Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed rule is the type of
action described as a categorical exclusion in 10 CFR 51.22(c)(2).
Therefore, neither an environmental impact statement nor an
environmental assessment has been prepared for this proposed rule.
Paperwork Reduction Act Statement
This proposed rule amends 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 and
paperwork requirements.
The proposed rule will relax existing information collection
requirements and will contain new information collections. The overall
effect will also reduce existing information collection requirements,
and the overall public burden of this collection of information is
expected to be decreased by 170 hours per year per site. These
estimates for both reduction and addition to burden include the time
required for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
The U.S. Nuclear Regulatory Commission is seeking public comment on
the potential impact of the collection of information contained in the
proposed rule. Comments to the OMB on the collection of information or
on the following issues must be submitted by June 10, 1996.
1. Is the proposed collection of information necessary for the
proper performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the burden estimate 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?
Send comments regarding these burden estimates or any other aspect
of this collection of information, including suggestions for reducing
the burden, to the Information and Records Management Branch (T-6 F33),
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to
the Desk Officer, Office of Information and Regulatory Affairs, NEOB-
10202, (3150-0146), Office of Management and Budget, Washington, DC
20503.
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.
Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed rule. The analysis examines the benefits, cost savings, and
costs of the alternatives considered by the Commission. The draft
analysis is available for inspection in the NRC Public Document Room,
2120 L Street NW. (Lower Level), Washington, DC. Single copies may be
obtained from Loren L. Bush, Jr., Office of Nuclear Reactor Regulation,
U.S. Nuclear Regulatory Commission, Washington, DC, telephone (301)
415-2944.
Regulatory Flexibility Act Certification
In accordance with the Regulatory Flexibility Act of 1980, (5
U.S.C. 605(b)), the Commission certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
This proposed rule affects only the licensing and operation of nuclear
power plants and activities associated with the possession or
transportation of Category I material. The companies that own these
plants do not fall within the scope of the definition of ``small
entities'' set forth in the Regulatory Flexibility Act or the size
standards adopted by the NRC on April 11, 1995 (60 FR 18344--10 CFR
2.810).
Backfit Analysis
This proposed rule would modify a prior Commission position by
adding new requirements and reducing other requirements. The
modifications are intended to improve the effectiveness of the rule in
the light of demonstrated program performance and lessons learned since
the implementation of the rule and to enhance overall program
integrity. Some of the modifications would be made to make the rule
consistent with modifications to the national standards on drug testing
promulgated by the Department of Health and Human Services. Other
modifications are intended to prevent subversion of the testing process
(examples include: limiting the time between notification and testing,
using a narrower temperature range to make it more difficult to submit
a surrogate sample), further ensure the accuracy and integrity of
testing (examples include: determining specimen quality, using a
narrower temperature range, and requiring timely shipping and testing
of specimens to prevent degradation of specimens), clarify actions for
removal and return to service, incorporate advances in technology
(example: measures to eliminate ``false positives'' from legitimate use
of amphetamines), and protect individual rights.
The proposed changes are, for the most part, minor program
adjustments or clarifications and do not alter the Commission's
original intent. Furthermore, the modifications would better achieve
the level of assurance in the accuracy of results and the integrity of
the testing process which was originally intended. The NRC believes
that some of the changes are needed to minimize the vulnerabilities
that are being exploited by substance abusers.
To facilitate public consideration of these proposed changes, the
Commission has placed the proposed rule changes into the three groups
appearing below. The first group consists of those changes intended to
conform the rule to the HHS Mandatory Guidelines that have been
modified since the rule was last revised. Subgroup IA lists those
changes intended to make the NRC rule compatible with the HHS
Guidelines as revised. Because the Commission continues to desire to
permit more stringent programs than set forth in the HHS Guidelines, it
was necessary to adjust some of the new HHS requirements to meet the
needs of the nuclear power industry. These are listed in subgroup IB.
[[Page 21129]]
The second group consists of those rule changes that would reduce
licensees' regulatory burden. Subgroup IIA lists those changes in this
category for which the Commission was able to calculate specific
monetary savings to licensees. Some of the proposed changes in the
second group would provide licensees with FFD program administrative
flexibility that would provide some indeterminate reduction in burden.
These changes are found in subgroup IIB.
Group III contains several proposed revisions that the Commission
believes to be worthwhile and necessary to better accomplish the FFD
rule's objectives. Subgroup IIIA consists of those proposed revisions
that are particularly important to achieving the rule's objectives.
These include revisions designed to reduce the incidence of subversion
of drug and alcohol testing and to enhance the rule's protection of the
rights of workers subject to the rule. The proposed changes appearing
in subgroup IIIB would serve to clarify the rule's existing
requirements, reduce ambiguities that have often resulted in
interpretative debates, and make other administrative changes. Some of
the Group III changes, such as establishing a more restrictive
temperature range, would result in a departure from the HHS guidelines.
Whether the proposed changes would, considered as a whole or
individually, provide a substantial increase in overall protection of
the public health and safety is a significant question. NRC staff is of
the preliminary view that these changes, although desirable, would not
provide a substantial increase. Public comment is specifically
requested on this question of substantiality.
If the Commission were unable to conclude at the final rulemaking
stage that these changes would provide a substantial increase in
overall protection, the further question arises whether the rule should
nevertheless go forward. One approach to continuation of the rulemaking
would be to view the rule as a whole and to conclude, if warranted,
that the rule's cumulative effect is to ease licensee burdens or leave
them essentially the same, rather than to increase them. This would be
consistent with an interpretation that the backfit rule does not apply
to relaxations of requirements. However, the mandatory nature of the
proposed rule, and effects on interested persons other than licensees,
could present complicating factors. Alternatively, the question is
presented whether those subject to the rule would decide not to object
to the new requirements in view of a perceived overall benefit and, if
so, whether non-objection could be grounds for not applying the backfit
rule. The basis here would be that the backfit rule was solely directed
at controlling objectionable impositions of additional requirements.
Public comment on these considerations is specifically invited.
LIST OF PROPOSED CHANGES TO 10 CFR PART 26
Group I: Adoption of National Standards
A. Changes To Ensure Compatibility With the HHS Guidelines as Revised
in June 1994
Sec. 26.24
(f) MRO to report FFD policy violation in writing.
(g) Ensure all collected specimens are tested and results are
reported.
Section 1.2 of Appendix A
Delete definition of permanent record book
Section 2.4 of Appendix A
(d) Courier signature not needed on chain-of-custody documents.
(g)(4) Eliminate requirement that tester request list of
medications prior to specimen collection.
(g)(9)+(24) Eliminate the requirement for a permanent record book.
(g)(10)+(15)+(23)+(24) Allow accompaniment or observation by person
of same gender, other than a collection site person.
(g)(11) Clarify fluid intake to assist in providing specimen.
(g)(13) Specify the temperature range for an acceptable urine
specimen in whole numbers.
(i) Clarify requirements concerning use of second, tamper-evident
shipping container.
Section 2.6 of Appendix A
Assure training of licensee testing facility managers
includes maintenance of chain of custody.
Section 2.7 of Appendix A
(f) Lower the cutoff level for marijuana screening tests from 100
ng/ml to 50 ng/ml.
(g) Modify the criteria for determining that a specimen is positive
for amphetamines.
(g) Require testing for d and l isomers of amphetamines.
(h) Eliminate batch reporting of results.
(p) Laboratory shall not have a conflict of interest with
licensee's MRO.
Section 2.8 of Appendix A
(e) Require blind quality control materials meet standards for
preparation, certification, and stability.
Section 2.9 of Appendix A
(b) MROs shall not have a conflict of interest with certified
laboratories.
Section 4.1 of Appendix A
(b) Note that licensees need to take appropriate measures when
testing outside HHS certification process.
B. Changes To Conform HHS Guidelines Revisions to the Framework of the
Original FFD Rule
Sec. 26.24
(d)(1)+(g) Require licensees to ensure that all collected specimens
are tested and results reported.
Section 2.4 of Appendix A
(g)(11) Reduce required minimum quantity of each urine specimen
from 60 ml to at least 30 ml (Where licensee chooses to test on site,
split specimens, or to test for additional drugs, more than 30 ml will
be necessary).
Section 2.7 of Appendix A
(e) Validity of specimens, i.e., tests for adulteration and
dilution at HHS laboratory.
(f) Permit multiple immunoassay (screening) tests for the same drug
or drug class.
(k) Clarifications to split specimen collection and dispatch
procedures and laboratory selection.
(k) Minimum time for requests by individuals to have split specimen
tested at another HHS laboratory.
Section 2.8 of Appendix A
(e) Reduce the maximum number and percentage of blind performance
specimens to be submitted per quarter but require a minimum.
Section 2.9 of Appendix A
(e) Minimum time for request by individual for reanalysis of
original specimen added.
Group II: Reduction in Burden
A. Changes With Quantitative Monetary Benefits
Sec. 26.2
(f) Eliminate duplicate testing under multiple programs.
Sec. 26.20
(f) Credit for unescorted access status granted by another
licensee.
[[Page 21130]]
Sec. 26.21
(b) Refresher training intervals extended from 1 to 2 years.
(b) Acceptance of generic portions of training provided by another
licensee.
Sec. 26.22
(c) Acceptance of generic portions of training provided by another
licensee.
Sec. 26.24
(a)(1) Flexibility in pre-access testing
--Tests within past 60 days may be considered pre-access tests if they
meet the standards of Part 26
--Access may be granted pending test results for individuals covered by
an acceptable FFD program for 2 consecutive weeks in the past 6 months
--No pre-access test for those transferring from another program who
have been covered by an FFD program meeting the requirements of Part 26
for 30 of the past 60 days.
(a)(2) Persons off site and unavailable when chosen for random
testing may be tested when next on site.
(a)(3) People tested for-cause for alcohol can return to duty while
awaiting urinalysis results.
(a)(5) Clarify existing testing requirements for persons
unavailable for testing for short periods and insure consistency with
the access authorization program.
(e) Limit time between notification and specimen collection.
Sec. 26.27
(a) Fitness history need not be obtained for those covered by other
programs or absent for 30 days or less.
Sec. 26.71
(d) Reduce frequency of program performance reports.
Sec. 26.80
(a) Change to performance based audit as the basis for reducing
required frequency.
Section 2.2 of Appendix A
(a) Permit prompt destruction of chain-of-custody forms showing
negative test results.
Section 2.3 of Appendix A
Extend reinvestigation interval for FFD program personnel
from 3 to 5 years.
Section 2.4 of Appendix A
(g)(18) Eliminate second breath specimen when test shows no
alcohol.
Section 2.7 of Appendix A
(e) Test questionable specimens to level of detection.
(h) Permit MRO staff to perform certain support functions.
(n) Eliminate need to audit areas covered by HHS inspections.
B. Changes That Provide Greater Flexibility and Indeterminate Monetary
Benefits
Sec. 26.2
(e) Reduce requirements during decommissioning.
Sec. 26.22
(c) Refresher training intervals may be extended from 12 to 36
months if written exam is given every 12 months.
Sec. 26.24
(a)(3) Provide flexibility in timeliness of for-cause test.
(f) MRO to complete review as soon as practicable and inform
management if determination of test result is delayed more than 14 days
after collection instead of completing review and notifying within 10
days after screening test.
(i) Flexibility for unusual medical conditions.
Sec. 26.27
(a) Certain aspects of fitness history to be limited to 5 years.
(a) Power reactor licensees usually need not obtain statements
responding to activities related to possession or transport of Category
I nuclear material.
(c) Allow records of FFD violations to be discarded after 5 years.
Sec. 26.29
(b) Permit provision of personal information for judicial or
administrative proceedings initiated by the subject individual.
(b) Permit provision of personal information to contractors and
vendors.
Section 2.2 of Appendix A
(a) Reduce time for retention of chain-of-custody forms showing
violations.
Section 2.4 of Appendix A
(g)(13) Allow licensees to set temperature range within rule
limits.
(g)(24) MRO or other designated medical person can authorize an
observed collection.
(j) Flexibility on licensee internal reporting and actions when
individual fails to cooperate.
Section 2.7 of Appendix A
(c) Flexibility in means of keeping specimens chilled.
(f)+(g) When licensee uses more stringent cutoff levels, tests at
level set by the rule can be calculated and need not be conducted.
(h) Reduce time for laboratories to report results.
(n) Flexibility provided if lab loses certification.
(p) Flexibility to use old or new NHTSA standards for breath
analysis equipment.
Section 2.8 of Appendix A
(f) Allow disposal of records of investigative findings after 3
years.
Section 2.9 of Appendix A
(d) Delete requirement for MRO determination of clinical evidence
of legal drugs.
(i) Allow disposal of records of negative test results, based on
scientific insufficiency, after 3 years.
Group III: Other Worthwhile Changes
A. Improvements Based on Experiences That the NRC Believes Are Needed
and Proposes To Adopt
Sec. 26.24
(a)(5) Require return-to-duty testing after extended absences or
denial of access.
(d)(1) Require onsite testers to determine validity of specimens on
site.
(h) Require back calculations for BACs between 0.02 and 0.04.
Sec. 26.27
(b)(3)+(4) Minimum sanctions for positive test for alcohol or the
use of alcohol within the protected area.
Sec. 26.28
Assure that appeal rights cover all types of violations,
including confirmed positive test results from applicants for
unescorted access and determinations of subversion.
Assure that relevant records are corrected if appeal is
successful.
Sec. 26.29
(c) Assure provision of copies of records to individuals upon
written request.
Section 2.4 of Appendix A
(g)(13)+(15) More restrictive temperature range for an acceptable
urine specimen.
(i) Laboratory must receive specimens within 48 hours of shipment.
Section 2.7 of Appendix A
(d) Specimens questionable for adulteration or dilution at
licensees' testing facilities must be shipped to HHS laboratory for
testing.
(e) Require onsite testers to determine validity of specimens on
site.
[[Page 21131]]
B. Clarifications to Existing Requirements, Changes To Reduce
Interpretive Debates, and Administrative Changes Which Are Also
Proposed
Sec. 26.2
(a) FFD program personnel to be covered by FFD rule.
Sec. 26.3
To support other rule changes, revise existing
definitions, create new definitions, and relocate some definitions from
Section 1.2 of Appendix A.
Sec. 26.7
New section ensures communications are sent to Document
Control Desk.
Sec. 26.8
(c) Section regarding burden estimates deleted.
Sec. 26.20
Minor clarifying and conforming edits (Introduction, (c),
(d), (e)(2)).
(a) Offsite involvement with drugs, subversion of the testing
process, and refusals to test added to policy statement.
(a) Clear and concise policy statement must be readily available.
(a) Policy must address impairment from legal drug use.
(d)(3)+(4) Policy must specify actions to be taken for subversion
and refusal to provide a specimen.
(e)(1) Declaration of fitness to perform tasks assigned when
contacted for call-in.
(f) Statement regarding Commission's right to review licensee
policy is deleted.
Sec. 26.21
(a) Minor administrative and clarifying edits.
Sec. 26.22
(c) Supervisory training for licensee employees must be completed
as soon as feasible following assignment to supervisory duty.
(c) Supervisory training for contractor employees must be completed
no later than 10 days following assignment to supervisory duty.
Sec. 26.23
(a) Clarify that persons with a known (to the contractor or vendor)
history of substance abuse must not receive assignments to the
protected area without the knowledge and consent of the licensee.
Sec. 26.24
(a)(1) Specify that all testing prior to granting unescorted access
is to be called pre-access testing.
(a)(1) Clarify that negative pre-access test result must be
obtained prior to access.
(a)(2) Random testing must be conducted on weekends, backshifts,
and holidays.
(a)(2) Individuals selected for random testing during an absence of
60 days or more to be tested only once to meet both random and return-
to-duty testing requirements (see Sec. 26.24 (a) (5)); tests to be
reported as random.
(a)(3) Clarify conditions that initiate for-cause test.
(a)(3) Ensure removal of unfit persons and determination of fitness
prior to return to duty.
(a)(4) Relocate follow-up testing requirements from
Sec. 26.27(b)(4/5) and clarify testing is to be unpredictable and
tailored to medical history.
(a)(4)+(c)+(d)+(f)+(g)+(h) Minor clarifying edits.
(h) Clarify that blood testing for alcohol is for purposes of
appeal.
(h) Clarify that any detectable quantity of alcohol in a blood
specimen may be considered to determine FFD violation.
Sec. 26.25
Clarify that EAPs must be designed to achieve early
intervention and must assure confidentiality.
Sec. 26.27
(a)+(b) Clarifying and conforming edits.
(b)(1)+(3)+(5) Clarification of requirements with respect to access
denial, removal, and return to service.
(b)(2) Conforming change regarding the threshold for alcohol policy
violation.
(b)(3) People suspended must still be covered by behavioral
observation, chemical testing, and sanctions for violations.
(c) Clarify that acts of subversion must be violations of policy
and result in denial of unescorted access for 3 years and that the
specific cause for removal must be provided in response to an inquiry.
(d) Clarify licensee handling of NRC contractors believed to be
unfit.
Sec. 26.28
Clarify that the appeals process must be objective and
conducted by persons not associated with the FFD program.
Clarify that an individual may submit additional relevant
information
Sec. 26.29
(b)+(c) Clarifying and conforming edits.
Sec. 26.70
(a) Clarifies the records that NRC may inspect.
Sec. 26.71
(b)+(c) Conforming edit.
(d) Include number of subversion attempts by type in program
performance reports.
Sec. 26.73
(a) Conforming changes.
(a) Provides additional examples of significant FFD events.
Sec. 26.80
(c) Conforming edit.
Section 1.1 of Appendix A
Minor clarifying edits.
Section 1.2 of Appendix A
Delete terms defined elsewhere in Part 26 or relocated to
Sec. 26.3.
Add definition of limit of detection (LOD).
Section 2.1 of Appendix A
(a) Conforming editorial changes.
(b) Conforming editorial changes.
(e) Minor edit.
Section 2.2 of Appendix A
(a)+(d) Minor and conforming edits.
Section 2.3 of Appendix A
Minor clarifying edits.
Fitness-for-duty program personnel tested by independent
personnel to the extent practicable.
Section 2.4 of Appendix A
(f) Minor clarifying changes.
(f) Current or previous specimen that fails to meet normal
standards constitutes a reason to require observed testing.
(g) Minor clarifying changes.
(g)(14)+ (15)+ (18)+ (19)+ (20)+ (23)+ (24)+ (27) Conforming and
clarifying changes.
(g)(23) Require secure sealing of specimen bottle.
(h)+(i) Minor clarification of sealing and labeling requirements.
(i) Continue to require specimens to be shipped to HHS laboratory
or cooled within 6 hours of collection as previously required by
Sec. 2.7 (c).
(i)+(j) Conforming changes.
Section 2.5 of Appendix A
Minor clarifying edits.
Section 2.7 of Appendix A
(b)+(d)+(f)+(g)+(h)+(i)+(k)+(l)+(m) Minor clarifying edits.
[[Page 21132]]
(c) Require chilling or testing within one day of arrival at HHS
laboratory.
(d) MRO to report adulteration or dilution to management
immediately.
(f)+(g) Standards for BAC established.
(h) Evidence of subversion must be reported by HHS laboratory.
(h) Laboratory retention of original chain-of-custody form.
(i) Specimens associated with subversion to be placed in long-term
storage.
(j) Retesting of adulterated or diluted specimens need only confirm
specimen not valid.
(m) HHS laboratories must have blood analysis capabilities.
(n) Specify that licensee contracts with HHS laboratories will
assure that copies of records are available to licensees and NRC
inspectors.
(p) Calibration standards (for calibrating equipment used to test
for alcohol and screen for drugs) must be current and valid.
(p) Two-year retention period for laboratory procedure manuals
after end of contract with licensee.
(p) Licensee to retain latest testing procedure manual until it is
no longer performing onsite testing.
Section 2.8 of Appendix A
(a)+(b)+(c)+(e)+(f) Minor clarifying and conforming edits.
(b) Laboratory results on blind performance specimens must be
evaluated and appropriate corrective actions taken.
(e) Change the proportion of blank and positive blind performance
test specimens.
(e) Assure regularity of submission of blind test specimens.
(e) Adulterate or dilute and spike some blind performance
specimens.
(e) Specify that initial 90-day period for blind performance
testing rate applies to all new contracts with HHS laboratories.
(f) Investigation of testing process errors and inclusion of report
of action taken.
(f) All false positive errors must be reported to NRC.
Section 2.9 of Appendix A
(a) Minor conforming edits.
(b)+(c)+(d)+(e)+(f) Clarifying and conforming changes to MRO duties
for reporting and review of results.
(d) Clarification of clinical evidence of abuse.
(f)+(g) Medical determination of fitness to perform duties defined.
(h) Conforming language for extrapolation of BAC results between
0.02 and 0.04
(i) Minor clarifying edits.
Section 3.2 of Appendix A
Section deleted and incorporated into Sec. 26.29(c).
Section 4.1 of Appendix A
(a) SAMHSA replaces NIDA and change of room number.
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, Sanctions.
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
adopt the following amendments to 10 CFR Part 26.
PART 26--[AMENDED]
1. The authority citation for part 26 is revised to read as
follows:
Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935,
936, 937, 939, 948, as amended, (42 U.S.C. 2073, 2111, 2112, 2133,
2134, 2137, 2201); secs. 201, 202, 206, 88 Stat. 1242, 1244, 1246,
as amended (42 U.S.C. 5841, 5842, 5846).
2. In Sec. 26.2, paragraphs (a) and (d) are revised, and new
paragraphs (e), and (f) are added to read as follows:
Sec. 26.2 Scope.
(a) The regulations in this part apply to licensees authorized to
operate a nuclear power reactor, to possess or use formula quantities
of SSNM, or to transport formula quantities of SSNM. Each licensee
shall implement a fitness-for-duty program which complies with this
part. The provisions of the fitness-for-duty program must apply to:
(1) All persons granted unescorted access to nuclear power plant
protected areas;
(2) Licensee, vendor, or contractor personnel required to
physically report to a licensee's Technical Support Center (TSC) or
Emergency Operations Facility (EOF) 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; and
(iii) Make measurements of Category IA Material;
(iv) Transport or escort Category IA Material; or
(v) Guard Category IA Material; and
(4) FFD program personnel who:
(i) Can link test results with the person who was tested;
(ii) Make removal and return-to-work recommendations or decisions;
(iii) Are involved in the selection and notification of employees
for testing and in the collection and on-site testing of specimens.
* * * * *
(d) The regulations in this part apply to the Corporation required
to obtain a certificate of compliance or an approved compliance plan
under part 76 of this chapter only if the Corporation elects to engage
in activities involving formula quantities of strategic special nuclear
material. When applicable, the requirements apply only to the
Corporation and personnel carrying out the activities specified in
Sec. 26.2(a)(3).
(e) For facilities in the process of being decommissioned, the
scope of a fitness-for-duty program may be reduced to persons and
specified areas as deemed appropriate by the NRC to protect public
health and safety.
(f) Persons performing activities under this part who are covered
by a program regulated by another Federal agency or State that meets
the general performance objectives of this part need only be covered by
those aspects of a licensee's fitness-for-duty program not included in
the Federal agency or state program.
3. Section 26.3 is amended by removing the definitions for follow-
up testing, random test, and suitable inquiry, revising aliquot,
confirmatory test, and confirmatory positive test, and adding in
alphabetical order the following definitions, abuse of legal drugs,
behavioral observation, blood alcohol concentration (BAC), HHS-
certified laboratory, laboratory-confirmed positive, licensee's testing
facility, medical determination of fitness, screening test, substance
abuse, subversion and subvert the testing process, supervisor, and
unconfirmed positive test result.
Sec. 26.3 Definitions.
Abuse of legal drugs means the use of a legal drug (e.g., alcohol,
prescription, over-the-counter drugs) in a manner that constitutes a
health or safety hazard to the individual or to others, including on-
the-job impairment. Legal or employment actions against an individual
for use of legal drugs constitute evidence of the existence of a health
or safety hazard.
Aliquot means a portion of a specimen used for testing. It is taken
as a sample representing the whole specimen.
Behavioral observation means observation by supervisors in the
course
[[Page 21133]]
of their contacts with other personnel to detect degradations in
performance, signs of impairment, or changes in behavior which may
indicate the need to evaluate an individual's fitness for duty.
Blood Alcohol Concentration (BAC) means a measure of the mass of
alcohol in a volume of blood.
* * * * *
Confirmatory test means a second analytical procedure to identify
the presence of a specific drug or drug metabolite which is independent
of the screening test and which uses a different technique and chemical
principle from that of the screening test in order to ensure
reliability and accuracy. (At this time, gas chromatography/mass
spectrometry (GC/MS) is the only authorized confirmation method for
cocaine, marijuana, opiates, amphetamines, and phencyclidine.) For
determining blood alcohol levels, a ``confirmatory test'' means a
second test using another breath alcohol analysis device. Additional
information may be obtained by gas chromatography analysis of blood.
Confirmed positive test means a laboratory confirmed positive test
result that has been verified as a violation of FFD policy by the
Medical Review Officer (MRO) after evaluation. A ``confirmed positive
test'' for alcohol is obtained as a result of a confirmation of blood
alcohol levels of 0.04 percent or higher with a second breath analysis
without MRO evaluation or as the result of an extrapolation back in
time (back calculation) performed by the MRO.
* * * * *
HHS-certified laboratory means a urine testing laboratory that
maintains certification to perform drug testing under the Department of
Health and Human Services (HHS) ``Mandatory Guidelines for Federal
Workplace Drug Testing Programs.''
* * * * *
Laboratory confirmed positive means the result of a confirmatory
test that has established the presence of drugs, or drug metabolites,
at a sufficient level to be an indication of prohibited drug use.
Licensee's testing facility means a drug testing facility operated
by the licensee or one of its vendors or contractors to perform on site
the initial testing of urine specimens.
Medical determination of fitness means the process whereby a
licensed physician, who may be the MRO, qualified to make such
determination examines and interviews an individual and reviews any
appropriate and relevant medical records, in accordance with standard
clinical procedures, in order to determine whether there are
indications that the individual may be in violation of the licensee's
FFD policy or is otherwise unable to safely and competently perform
duties. The qualifications for making the determination are related to
the fitness issues presented by the patient.
* * * * *
Screening test means an immunoassay screen for drugs or drug
metabolites to eliminate ``negative'' urine specimens from further
consideration, or the first breathalyzer test for alcohol. Initial
screening may be performed at the licensee's testing facility; a second
screen and confirmation testing for drugs or drug metabolites must be
conducted by a HHS-certified laboratory.
Substance abuse means the use, sale, or possession of illegal drugs
or the abuse of legal drugs (e.g., alcohol, prescription drugs, and
over-the-counter drugs) or other substances.
Subversion and Subvert the testing process mean an act intended to
avoid being tested or to bring about an inaccurate drug or alcohol test
result for oneself or others. Acts of subversion can occur at any stage
of the testing program including selection and notification of
individuals for testing, specimen collection, specimen analysis, and
testing result reporting processes and can include providing a
surrogate urine specimen, diluting a specimen, (in vivo or in vitro)
and adding an adulterant to a specimen.
* * * * *
Supervisor means any person who has the immediate oversight
responsibilities to direct activities of any other person or persons
within the protected area or has ongoing responsibility for the
supervision of an individual with unescorted access status while that
individual is not in the protected area.
* * * * *
Unconfirmed positive test result means the result of a screening
test for drugs and drug metabolites that indicates the presence of some
drug or drug metabolite and that has the potential to be confirmed
through GC/MS testing by an HHS-certified laboratory as a laboratory
confirmed positive test result, or the result of a screening test for
alcohol indicating a blood alcohol content of 0.02 percent or greater.
* * * * *
4. Section 26.7 is added to read as follows:
Sec. 26.7 Communications.
Except where otherwise specified in this part, all communications
and reports concerning the regulations in this part must be addressed
to the NRC Document Control Desk, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001. Copies of all communications must be sent to
the appropriate regional office and resident inspector. Communications
and reports may be delivered in person at the Commission's offices at
2120 L Street, NW., Washington, DC, or at 11555 Rockville Pike, One
White Flint North, Rockville, Maryland.
Sec. 26.8 [Amended].
5. In Sec. 26.8, paragraph (c) is removed.
6. In Sec. 26.20, the introductory text and paragraphs (a), (c),
(d), (e), introductory text, (e)(1), (e)(2), and (f) are revised to
read as follows:
Sec. 26.20 Written policy and procedures.
Each licensee subject to this part shall establish and implement
written policies and procedures designed to meet the general
performance objectives and specific requirements of this part. Each
licensee shall retain a copy of its latest written policy and
procedures as a record until the Commission terminates the licenses for
which for which the policy and procedures were developed. If any
portion of the policies and procedures are superseded, the superseded
material must be retained for at least three years. As a minimum,
written policies and procedures must address fitness for duty through
the following:
(a) An overall description of licensee policy on fitness for duty.
The policy must address use of and offsite involvement with illegal
drugs, abuse of legal drugs (e.g., alcohol, prescription and over-the-
counter drugs), subversion of the testing process, and refusals to
provide a specimen for testing. A clear and concise written statement
of this policy must be prepared and be in sufficient detail to provide
affected individuals with informtion on what is expected of them, and
what consequences may result from lack of adherence to the policy. This
statement must be readily available to all persons subject to the
policy.
(1) As a minimum, the written policy must prohibit the consumption
of alcohol--
(i) Within an abstinence period of at least 5 hours preceding any
scheduled working tour; and
(ii) During the period of any working tour.
(2) Licensee policy should also address other factors that could
affect
[[Page 21134]]
fitness for duty such as mental stress, fatigue, illness, and the use
of prescription and over-the-counter medications that could cause
impairment.
* * * * *
(c) Procedures to be utilized in testing for drugs and alcohol,
including procedures for protecting individuals providing a specimen
and the integrity of the specimen, and the quality controls used to
ensure the test results are valid and attributable to the correct
individual.
(d) A description of immediate and follow-on actions which will be
taken, and the procedures to be utilized, in those cases where persons
who are employed by licensees, vendors, or contractors, and are
assigned to duties within the scope of this part, are determined to
have--
(1) Been involved in the use, sale, or possession of illegal drugs;
(2) Consumed alcohol during the mandatory pre-work abstinence
period, while on duty, or to excess before reporting to duty as
demonstrated with a test that can be used to determine blood alcohol
concentration;
(3) Attempted to subvert the testing process by adulterating or
diluting specimens (in vivo or in vitro), substituting specimens, or by
any other means; or
(4) Refused to provide a specimen for analysis.
(e) A procedure that will ensure that persons called in to perform
an unscheduled working tour are fit to perform the task assigned. As a
minimum, this procedure must--
(1) Require a statement to be made by a called-in person when
contacted as to whether he or she considers himself or herself fit to
perform the task assigned and whether he or she has consumed alcohol
within the length of time stated in the pre-duty abstinence policy;
(2) If alcohol has been consumed within this period, require a
determination of fitness for duty by breath analysis or other means
(collection of urine under Sec. 26.24(a)(3) is not required); and
* * * * *
(f) Licensees seeking to grant unescorted access pursuant to 10 CFR
73.56 to personnel covered by another licensee's FFD program that
complies with this part may credit that licensee's program through
verification that the individual is currently and will continue to be
subject to the random testing and behavioral observation programs of
either his or her employer or those of the host licensee.
7. In Sec. 26.21, the introductory text of paragraph (a) and
paragraphs (a)(2) and (b) are revised to read as follows:
Sec. 26.21 Policy communications and awareness training.
(a) Persons assigned to activities within the scope of this part
must be provided with appropriate training to ensure they understand--
* * * * *
(2) The personal and public health and safety hazards associated
with the use of illegal drugs and the abuse of legal drugs including
alcohol;
* * * * *
(b) Initial training in the five topics in paragraph (a) of this
section must be completed before assignment to activities within the
scope of this part. Refresher training in those five topics must be
completed on a nominal 24 month frequency or more frequently where the
need is indicated. A record of the training must be retained for a
period of at least three years. Licensees may accept training of
individuals who have been subject to another Part 26 program and who
have had initial or refresher training within the 24 months before
assignment provided that training by the accepting licensees in the
site-specific topics covered by paragraphs (a) (1), (4), and (5) of
this section is completed before the granting of unescorted access to
the protected area.
8. In Sec. 26.22, the introductory text of paragraph (a) and
paragraphs (a)(4) and (c) are revised to read as follows:
Sec. 26.22 Training of supervisors and escorts.
(a) Managers and supervisors of activities within the scope of this
part must be provided appropriate training to ensure they understand--
* * * * *
(4) Behavioral observation techniques for detecting degradation in
performance, impairment, or changes in an individual's behavior; and
* * * * *
(c) Initial training for escorts and licensee employees'
supervisors must be completed before assignment of duties within the
scope of this part, except that after an initial supervisory
assignment, the initial training must be completed as soon as feasible
but no later than 3 months following the assignment of supervisory
duties. Initial training for supervisors of contractor personnel must
be completed before assignment of the supervised contractor personnel
to duties within the scope of this part or within 10 days after initial
supervisory assignment, whichever is later. Refresher training must be
completed on a nominal 12-month frequency, or more frequently where the
need is indicated. A written examination on the training material given
on a nominal 12-month frequency may be used in lieu of refresher
training. The written examination must require a demonstration of
adequate knowledge of the areas covered in paragraph (a) of this
section. Refresher training must be completed on a nominal 36-month
frequency even if examinations are used to fulfill this requirement
during the interim period. A record of the training or examination in
lieu of training must be retained for a period of at least three years.
Licensees may accept training of individuals who have been subject to a
part 26 program and who have had initial or refresher training within
the 12 months before assignment provided that training by the accepting
licensee in the topics covered by paragraphs (a)(1), (2), and (5) of
this section is completed before granting unescorted access to the
protected area.
9. In Sec. 26.23, the introductory text of paragraph (a) and
paragraph (a)(2) are revised to read as follows:
Sec. 26.23 Contractors and vendors.
(a) All contractor and vendor personnel performing activities
within the scope of this part for a licensee must be subject to either
the licensee's program relating to fitness for duty, or to a program,
formally reviewed and approved by the licensee, which meets the
requirements of this part. Written agreements between licensees and
contractors or vendors for activities within the scope of this part
must be retained for the life of the contract and will clearly show
that--
* * * * *
(2) Personnel with a known history of substance abuse or having
been denied access or removed from activities within the scope of this
part at any nuclear power plant for violations of a fitness-for-duty
policy will not be assigned to work within the scope of this part
without the knowledge and consent of the licensee.
* * * * *
10. In Sec. 26.24, paragraphs (a), (c), (d)(1), the introductory
text of (d)(2), (d)(2)(i) and (d)(2)(iv) are revised, paragraphs (e),
(f), and (g) are redesignated as paragraphs (f), (g), and (h) and
revised, and new paragraphs (e) and (i) are added to read as follows:
Sec. 26.24 Chemical testing.
(a) To provide a means to deter and detect substance abuse, the
licensee shall implement the following chemical testing programs for
persons subject to this part:
[[Page 21135]]
(1)(i) Preaccess testing for drugs and alcohol must be conducted
within 60 days before the initial granting of unescorted access to
protected areas or assignment to activities within the scope of this
part unless the individual:
(A) Has been covered by a program meeting the requirements of this
part for at least 30 days during the 60 days immediately previous to
the granting of unescorted access; and
(B) Has no history of substance abuse.
(ii) Any negative drug and alcohol test meeting the standards of
this part and performed within 60 days before granting unescorted
access may serve as the preaccess test. A negative test result must be
obtained before the granting of unescorted access unless the individual
has no history indicating the use of illegal drugs or the abuse of
legal drugs (e.g., alcohol, prescription, and over-the-counter drugs)
and has either had a negative test result on a test meeting the
standards of this part performed within six months before granting
unescorted access or has been covered by a program meeting the
standards of this part for two consecutive weeks during that period.
(2) Unannounced drug and alcohol tests must be imposed in a
statistically random and unpredictable manner so that all persons in
the population subject to testing have an approximately equal
probability of being selected and tested. Random testing must include
testing during all types of work periods, including weekends,
backshifts, and holidays. The tests must be administered so that a
person completing a test is immediately eligible for another
unannounced test. At a minimum, tests must be administered on a nominal
weekly frequency and at various times during the day. Reasonable
efforts must be made to test persons selected for random testing.
Persons off site when selected for testing, and not reasonably
available for testing in a timely manner, must be tested upon returning
to the site. For persons off site for more than sixty days, such tests
will fulfill the requirement for return-to-duty testing and should be
reported to the NRC as random tests. Random testing must be conducted
at an annual rate equal to at least 50 percent of the workforce.
(3)(i) For-cause drug and alcohol testing must be conducted:
(A) Following any observed behavior or physical condition that
creates a reasonable suspicion of possible substance abuse including
attempts to subvert the testing process;
(B) After accidents involving a failure in individual performance
resulting in personal injury, in a radiation exposure or release of
radioactivity in excess of regulatory limits, or actual or potential
substantial degradations of the level of safety of the plant if there
is reasonable suspicion that the individual's performance contributed
to the event; and
(C) after receiving credible information that an individual is
abusing drugs or alcohol.
(ii) The individual's unescorted access status must be suspended
until pronounced fit for duty based on a medical determination of
fitness. If the test is based on suspected use of alcohol and the
breath analysis is negative, the individual, if determined fit for duty
by a medical determination of fitness, may be returned to duty pending
results of urinalysis for drugs. For-cause drug and alcohol testing
must be conducted as soon as practicable, but within no more than 2
hours for an alcohol test and 8 hours for specimen collection for a
drug test.
(4) Follow-up testing must be conducted on an unannounced and
unpredictable basis to verify continued abstention from the use of
substances as covered under this part. An individual:
(i) Whose unescorted access is reinstated after a suspension under
Sec. 26.27(b)(3); or
(ii) Is granted unescorted access after removal under Sec. 26.27(b)
(3) or (4) must be subject to follow-up testing that is tailored to the
individual's medical history but not less frequently than 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.
(5) Return-to-duty testing must be conducted when a person seeks to
regain unescorted access to protected areas of the site in question
after an absence from the possibility of being tested under that site
licensee's program for more than 60 days or when a person seeks to
regain unescorted access after having been denied access under the
provisions of Sec. 26.27(b). Any negative drug and alcohol test meeting
the standards of this part and performed within 60 days before the
granting of unescorted access may serve as the return-to-duty test
except in the case of those who have been denied access under the
provisions of Sec. 26.27(b). A negative test result must be obtained
before the granting of unescorted access unless the individual has no
history indicating the use of illegal drugs or the abuse of legal drugs
(e.g., alcohol, prescription and over-the-counter drugs) and either has
had a negative test result on a test meeting the standards of this part
performed within six months before the reinstatement of unescorted
access or has been covered by a program meeting the standards of this
part for two consecutive weeks during that period.
* * * * *
(c) Licensees shall test specimens collected under each type of
test listed in Sec. 26.24(a) for all substances described in paragraph
2.1(a) of the NRC Guidelines (Appendix A to part 26). In addition,
licensees may consult with local law enforcement authorities,
hospitals, and drug counseling services to determine whether other
substances with abuse potential are being used in the geographical
locale of the facility and the local workforce. When appropriate, other
substances so identified may be added to the panel of substances for
testing. Appropriate cut-off limits must be established by the licensee
for these substances.
(d)(1) All collected urine and blood specimens must be forwarded to
a laboratory certified by the Department of Health and Human Services
(HHS), except that licensees may conduct tests of aliquots to determine
which specimens are negative and need no further testing, provided the
licensee'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. All such testing of
specimens must include tests to ensure specimen validity as required by
section 2.7(e) of Appendix A to part 26. Quality control procedures for
screening tests by a licensee's testing facility must include the
processing of blind performance test specimens and the submission to
the HHS-certified laboratory of a sampling of specimens initially
analyzed as negative. Except for the purposes discussed in
Sec. 26.24(d)(2), access to the results of the above screening tests
must be limited to the licensee's testing staff, the Medical Review
Officer (MRO), the Fitness-for-Duty Program Manager, and employee
assistance program staff, when appropriate.
(2) An individual may not be removed or temporarily suspended from
unescorted access or be subjected to other administrative action based
solely on an unconfirmed positive result from any drug test, other than
for marijuana (THC) or cocaine, unless other evidence indicates that
the individual is impaired or might otherwise pose a safety hazard.
With respect to on-site screening tests for marijuana (THC) and
cocaine, licensee management may be informed and licensees may
temporarily suspend individuals from unescorted access or from normal
duties or take lesser
[[Page 21136]]
administrative actions against the individual based on an unconfirmed
positive test result provided the licensee complies with the following
conditions:
(i) For the drug for which action will be taken, at least 85
percent of the unconfirmed positive test results from on-site screening
tests during the last 12-month data reporting period submitted to the
Commission under Sec. 26.71(d) were subsequently reported as positive
by the HHS-certified laboratory as the result of a GC/MS confirmatory
test.
* * * * *
(iv) No disclosure of the temporary removal or suspension of, or
other administrative action against, an individual whose test is not
subsequently confirmed as a violation of FFD policy may be made in
response to a suitable inquiry conducted under the provisions of
Sec. 26.27(a), a background investigation conducted under the
provisions of Sec. 73.56, or to any other inquiry or investigation. For
the purpose of assuring that no records have been retained, access to
the system of files and records must be provided to licensee personnel
conducting appeal reviews, inquiries into an allegation, or audits
under the provisions of Sec. 26.80, or to an NRC inspector or other
Federal officials. The tested individual must be provided a statement
that the records specified in paragraph (d)(2)(iii) of this section
have not been retained and must be informed in writing that the
temporary removal or suspension or other administrative action that was
taken will not be disclosed and need not be disclosed by the individual
in response to requests for information concerning removals,
suspensions, administrative actions or history of substance abuse.
(e) The period of time allowed between the notification of the
individual and the actual collection of a specimen must be kept at a
minimum consistent with operational constraints. Whenever practicable,
the individual should not be allowed the time or opportunity to obtain
materials or take any action that would subvert the testing process or
the test results.
(f) The Medical Review Officer shall complete the review of test
results reported by the HHS-certified laboratory and notify licensee
management as soon as practicable. The MRO shall report all
determinations of violations of the licensee's FFD policy (e.g.,
positive test results and attempts to avoid detection) to management in
writing and in a manner designed to ensure confidentiality of the
information. To assure that action is taken immediately, provisions
must be made to ensure that the MRO is able to contact appropriate
licensee management at any time. Should the MRO's review not be
completed within 14 days of the collection of a specimen, licensee
management must be advised of available test results, the status of the
review, the reasons for the delay, and appropriate recommendations.
(g) All testing of urine specimens for drugs, except screening
tests performed by licensees under paragraph (d) of this section, must
be performed in a laboratory certified by the U.S. Department of Health
and Human Services (HHS) for that purpose consistent with its standards
and procedures for certification. Except for suspect specimens
submitted for special processing (section 2.7(d) of Appendix A to part
26), all specimens sent to HHS-certified laboratories must be subject
to screening analysis by the laboratory and all specimens screened as
unconfirmed positives must be subject to confirmatory testing by gas
chromatography/mass spectroscopy analysis by the laboratory. Licensees
shall submit blind performance test specimens to HHS-certified
laboratories in accordance with the NRC Guidelines. Licensees must
ensure that all collected specimens are tested and that laboratories
report results for all specimens sent for testing, including blind
performance test specimens.
(h) Tests for alcohol must be administered by breath analysis using
breath alcohol analyses devices meeting evidential standards described
in section 2.7(p)(3) of Appendix A to part 26. If the screening test
shows a breath alcohol content indicating a BAC of 0.02 percent or
greater, a confirmatory test for alcohol must be performed using
another breath measurement instrument. A confirmatory test result
showing a breath alcohol content indicating a BAC between 0.02 percent
and 0.04 percent must be forwarded to the MRO for evaluation as
described in section 2.9(h) of Appendix A to part 26. A confirmatory
test for alcohol indicating a blood alcohol concentration (BAC) of 0.04
percent or greater must be declared a positive test. Further testing
for alcohol must be administered if demanded by the individual for the
purposes of obtaining additional information that could be considered
during an appeal pursuant to Sec. 26.28. Any such test must be a gas
chromatography analysis of blood performed on a blood specimen drawn,
with the consent of the individual, promptly after the confirmatory
breath analysis. Any detectable quantity of alcohol in the blood
specimen may be considered, including extrapolation back in time, to
determine if a violation of the FFD policy occurred.
(i) If an individual has a medical condition that makes collection
of breath, blood, or urine specimens difficult or hazardous, the MRO,
in consultation with the treating or personal physician, may authorize
an alternative evaluation process, tailored to the individual case, for
determining whether a violation of fitness-for-duty policy has
occurred, provided this process includes measures to prevent subversion
and can achieve results comparable to those produced by urinalysis for
illegal drugs and breath analysis for alcohol.
11. Section 26.25 is revised to read as follows:
Sec. 26.25 Employee assistance programs (EAP).
Each licensee subject to this part shall maintain an employee
assistance program to strengthen fitness-for-duty programs by offering
assessment, short-term counseling, referral services, and treatment
monitoring to employees with problems that could adversely affect the
performance of activities within the scope of this part. Employee
assistance programs must be designed to achieve early intervention. The
EAP must also provide for confidential assistance except that the
employee assistance program staff shall inform licensee management when
a determination has been made that any individual's condition
constitutes a hazard to himself or herself or others (including those
who have self-referred).
12. Section 26.27 is revised to read as follows:
Sec. 26.27 Management actions and sanctions to be imposed.
(a)(1)(i) Before the initial granting of activities within the
scope of this part, as described in Sec. 26.2(a), the licensee shall
obtain a written statement from the individual as to whether he or she:
(A) Has in the past 5 years used, sold, or possessed any illegal
drugs, or had a legal or employment action taken against him or her for
alcohol or drug use;
(B) Has in the past 5 years been determined to have violated a
fitness-for-duty policy, or as a result of action taken in accordance
with an FFD policy been denied initial assignment to activities within
the scope of this part as described in Sec. 26.2(a), or has been
subject to a plan for treating substance abuse (except for self-
referral for treatment); or
(C) Has at any time as a result of action taken in accordance with
an FFD
[[Page 21137]]
policy been removed from activities within the scope of this part as
described in Sec. 26.2(a).
(ii) Power reactor licensees need not obtain statements responding
to the activities listed in Sec. 26.2(a)(3) unless the background
investigation conducted in accordance with 10 CFR 73.56 indicates the
person was previously employed by a licensee authorized to possess or
transport Category I nuclear material.
(2) The statement must include the individual's declaration as to
the specific type, duration, and resolution of any such matter.
(3) The licensee shall complete a suitable inquiry on a best-
efforts basis to verify the accuracy of the individual's written
statement under paragraphs (a)(1) and (a)(2) of this section. This
suitable inquiry should cover at least the past 5 years but in no case
less than the past 3 years.
(4) If a record of the type described in paragraphs (a) (1), (2),
and (3) of this section is established which raises a concern about the
person's history of alcohol or drug use, the new assignment to
activities within the scope of this part or granting of unescorted
access must be based upon a management and medical determination of
fitness for duty and the establishment of an appropriate follow-up
testing program, as specified in Sec. 26.24(a)(4). The restrictions of
paragraph (b) of this section must be observed. To meet the suitable
inquiry requirement, the identity of persons denied unescorted access
or removed under the provisions of this part and the circumstances for
the denial or removal, including test results, will be made available
in response to a licensee's, contractor's, or vendor's inquiry
supported by a release signed by the individual being investigated that
authorizes the disclosure of the information. A suitable inquiry need
not be conducted for any period of 30 days or less that the individual
was not covered by an FFD program meeting the requirements of this
part.
(5) Failure by an individual to list reasons for removal or
revocation of unescorted access or failure to authorize the release of
information is sufficient cause for denial of unescorted access.
Temporary unescorted access pursuant to 10 CFR 73.56 may not be
affected by this part provided that the applicant for unescorted access
passes a chemical test conducted according to the requirements of
Sec. 26.24(a)(1).
(b) Each licensee subject to this part shall, at a minimum, take
the following actions. The requirements of this paragraph do not
prohibit the licensee from taking more stringent action.
(1) Personnel, including applicants, who are impaired, those whose
fitness may be questionable, and those determined to have violated the
licensee's fitness-for-duty policy shall be immediately denied
unescorted access or otherwise removed from activities within the scope
of this part. These persons may be assigned to or returned to their
duties only after impairing or questionable conditions are resolved and
the individual is determined to be fit to safely and competently
perform activities within the scope of this part by an appropriate
manager and a licensed physician qualified to make the medical
determination of fitness.
(2) Lacking any other evidence to indicate the use, sale, or
possession of illegal drugs or use of alcohol on site, the following
must be presumed to be an indication of off-site drug or alcohol use in
violation of the company FFD policy:
(i) A laboratory confirmed positive test result that is verified by
the MRO as a policy violation; and
(ii) A confirmatory breath test for alcohol that indicates the
individual had a BAC of 0.04 percent or greater during any scheduled
working tour.
(3) The first violation of the FFD policy involving a confirmed
positive drug or alcohol determination must, at a minimum, result in
immediate removal from activities within the scope of this part for at
least 14 days and referral to the EAP for assessment and counseling
during any suspension period. Plans for treatment, follow-up, and
future employment, if applicable, must be developed, and any
rehabilitation program deemed appropriate must be initiated during such
suspension period. Although the individual must be removed from
activities covered by this part, the individual must continue to be
covered during any suspension period by the licensee's FFD program with
respect to behavioral observation if in a work status, chemical
testing, and sanctions for violations of the licensee's FFD policy.
Before an individual is permitted to be returned to duty or assigned to
perform activities within the scope of this part, the individual must
be determined to be fit to safely and competently perform such
activities by an appropriate manager and a licensed physician qualified
to make the medical determination of fitness. A return-to-duty test
under Sec. 26.24(a)(5) must be conducted before the individual may be
returned to duty and follow-up testing under Sec. 26.24(a)(4) must be
conducted to verify continued abstinence from the use of substances.
Any subsequent violation of FFD policy, including during an assessment
or treatment period, must immediately result in removal from activities
described in Sec. 26.2(a) for a minimum of 3 years from the date of
removal.
(4) Any individual determined to have been involved in the sale,
use, or possession of illegal drugs or the use of alcohol while, as
applicable, within a protected area of any nuclear power plant, within
a facility that is licensed to possess or use SSNM, or within a
transporter's facility or vehicle, must immediately be removed from
activities within the scope of this part as described in Sec. 26.2(a)
for a minimum of 5 years from the date of removal.
(5) Persons removed for periods of three years or more under the
provisions of paragraphs (b)(2), (b)(3), (b)(4), and (c) of this
section and who would have been removed under the current standards of
a hiring licensee, may be granted unescorted access and assigned duties
within the scope of this part by a licensee subject to this part only
when the hiring licensee receives satisfactory medical assurance that
the person has abstained from the use of illegal drugs or the abuse of
legal drugs (e.g., alcohol, prescription and over-the-counter drugs)
for at least three years. Before an individual is permitted to be
returned or assigned to perform activities within the scope of this
part, the individual must be determined to be fit to safely and
competently perform these activities by an appropriate manager and a
licensed physician qualified to make the medical determination of
fitness. A return-to-duty test under Sec. 26.24(a)(5) must be conducted
before the individual may be assigned duties and follow-up testing
under Sec. 26.24(a)(4) must be conducted to verify continued abstinence
from the use of substances. Any further violation of FFD policy must
immediately result in permanent denial from activities described in
Sec. 26.2(a).
(6) Paragraphs (b) (2), (3), (4), and (5) of this section do not
apply to valid prescriptions or over-the-counter drugs. Licensee
sanctions for confirmed abuse of valid prescription and over-the-
counter drugs must be sufficient to deter abuse of legally obtainable
substances as a substitute for abuse of proscribed drugs.
(c) Any act or attempted act to subvert the testing process must be
a violation of the licensee's FFD policy and must result in denial of
unescorted access for a minimum of 3 years. A refusal to provide a
specimen, effort to subvert the testing process, or resignation before
removal for violation of company fitness-for-duty policy concerning
drugs and alcohol must be recorded and
[[Page 21138]]
provided in response to a suitable inquiry. The specific cause for a
removal, e.g., that a laboratory confirmed positive test result was
obtained and that the individual resigned before an MRO review, must
also be provided in response to a suitable inquiry. A record of these
actions must be retained for five years following denial of any access
authorization for the purpose of meeting the requirements of
Sec. 26.27(a).
(d) If a licensee has a reasonable belief that an NRC employee or
NRC contractor may be under the influence of any substance, or
otherwise unfit for duty, the licensee may not deny access but shall
escort the individual. In any instance of this occurrence, the
appropriate Regional Administrator must be notified immediately by
telephone. During other than normal working hours, the NRC Operations
Center must be notified.
13. Section 26.28 is revised to read as follows:
Sec. 26.28 Appeals.
Each licensee subject to this part, and each contractor or vendor
implementing a fitness-for-duty program under the provisions of
Sec. 26.23, shall establish a procedure for licensee and contractor or
vendor employees and applicants for unescorted access to appeal a
determination of a violation of FFD policy. The procedure must provide
notice to the individual of the grounds for the determination of a
violation of FFD policy, and must provide an opportunity to respond and
to submit additional relevant information. The procedure must provide
for an objective, impartial review of the facts relating to the
determination of a violation of FFD policy. The review must be
conducted by persons not associated with the administration of the FFD
program, as described in Sec. 26.2(a)(4), and may include internal
management. If the appeal is successful, the relevant records must be
corrected. A licensee review procedure need not be provided to
employees of contractors or vendors when the contractor or vendor is
administering its own alcohol and drug testing.
14. In Sec. 26.29, paragraph (b) is revised and paragraph (c) is
added to read as follows:
Sec. 26.29 Protection of information.
* * * * *
(b) Licensees, contractors, and vendors may not disclose the
personal information collected and maintained to persons other than
assigned Medical Review Officers, other licensees, contractors or
vendors, or their authorized representatives legitimately seeking the
information as required by this part for unescorted access decisions
and who have obtained a release from current or prospective employees
or contractor personnel, NRC representatives, appropriate law
enforcement officials under court order, the subject individual or his
or her representative, or to those licensee representatives who have a
need to have access to the information in performing assigned duties,
including medical determinations of fitness and audits of licensee,
contractor, and vendor programs, to the presiding officer in a judicial
or administrative proceeding initiated by the subject individual, to
persons deciding matters on review or appeal, and to other persons
pursuant to court order. This section does not authorize the licensee,
contractor, or vendor to withhold evidence of criminal conduct from law
enforcement officials.
(c) Upon receipt of a written request by the subject individual,
the licensee, contractor, or vendor possessing such records shall
promptly provide copies of all records pertaining to the determination
of a violation of the licensee's FFD policy, including test results,
MRO reviews, and management determinations of results pertaining to the
subject individual. Records relating to the results of any relevant
laboratory certification review or revocation of certification
proceeding shall be obtained from the relevant laboratory and provided
to the subject individual upon request.
15. In Sec. 26.70, paragraph (b)(2) is revised to read as follows:
Sec. 26.70 Inspections.
* * * * *
(b) * * *
(2) Duly authorized representatives of the Commission may inspect,
copy, or take away copies of any licensee, contractor, or vendor
documents, records, and reports related to implementation of the
licensee, contractor, or vendor fitness-for-duty program under the
scope of the contracted activities. This includes documents, records,
and reports of FFD service contractors (e.g., contracted HHS
laboratory, MRO, EAP, and specimen collection services) related to
licensee, contractor, or vendor FFD programs.
16. In Sec. 26.71, paragraphs (b), (c) and (d) are revised to read
as follows:
Sec. 26.71 Recordkeeping requirements.
* * * * *
(b) Retain relevant records pertaining to the determination of a
violation of the FFD policy and the related personnel actions for a
period of at least five years;
(c) Retain records of persons made ineligible for three years or
longer for assignment to activities within the scope of this part under
the provisions of Sec. 26.27(b) (3), (4), and (5) or (c), until the
Commission terminates each license under which the records were
created; and
(d) Collect and compile fitness-for-duty program performance data
on a standard form and submit these data covering the calendar year
January 1st through December 31st to the Commission by March 1st of the
following year. The data for each site (corporate and other support
staff locations may be separately consolidated) must include: random
testing rate; drugs tested for and cut-off levels, including results of
tests using lower cut-off levels and tests for other drugs; workforce
populations tested; numbers of tests and results by population, and
type of test (i.e., pre-access, random, for-cause, etc.); substances
identified; summary of management actions; number of subversion
attempts by type; and a list of events reported. The data must be
analyzed and appropriate actions taken to correct program weaknesses.
The data and analysis must be retained for three years. Any licensee
choosing to temporarily suspend individuals under the provisions of
Sec. 26.24(d) shall report test results by process stage (i.e., on-site
screening, laboratory screening, confirmatory tests, and MRO
determinations) and the number of temporary suspensions or other
administrative actions taken against individuals based on on-site
unconfirmed screening positives for marijuana (THC) and for cocaine.
17. In Sec. 26.73, paragraph (a) is revised to read as follows:
Sec. 26.73 Reporting requirements.
(a) Each licensee subject to this part shall inform the Commission
of significant fitness-for-duty events including, but not limited to:
(1) Sale, distribution, use, possession, or presence of illegal
drugs or use of alcohol within the protected area;
(2) Any acts by any person licensed under 10 CFR part 55 to operate
a power reactor, by any supervisory personnel assigned to perform
duties within the scope of this part, or by any FFD program personnel
as specified in Sec. 26.2(a)(4)--
(i) Involving the sale, use, or possession of a controlled
substance;
(ii) Resulting in determinations that such an individual has
violated the licensee's FFD policy;
(iii) Involving use of alcohol within the protected area; or
[[Page 21139]]
(iv) Resulting in a determination of unfitness for scheduled work
due to the consumption of alcohol;
(3) Any act that would cast doubt on the honesty and integrity of
the FFD program personnel specified in Sec. 26.2(a)(4); and
(4) Arrest of a worker for sale, distribution, use, or possession
of illegal drugs on or off site.
* * * * *
18. In Sec. 26.80, paragraphs (a) and (c) are revised to read as
follows:
Sec. 26.80 Audits.
(a) Each licensee subject to this part shall audit the fitness-for-
duty program as needed but no less frequently than every 36 months.
Licensees are responsible for determining the appropriate frequency,
scope, and depth of auditing activities within the three-year period
based on 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.'' As soon as reasonably practicable, but not later than 12
months after a significant change in fitness-for-duty personnel,
procedures, or equipment, licensees shall audit the particular program
element(s) affected by that change to assure continued program
effectiveness. Program elements which must continue to be audited
nominally every 12 months include FFD program elements implemented by
contractors and vendors under the provisions of Sec. 26.23, testing
performed at HHS-certified laboratories, and FFD services provided to
the licensee by contractors and vendors off site or not under the
direct daily supervision or observation of licensee personnel.
Licensees may accept audits of contractors and vendors conducted by
other licensees and need not re-audit the same contractor or vendor for
the same period of time. Each sharing utility shall maintain a copy of
the audit report, to include findings, recommendations, and corrective
actions. Licensees retain responsibility for the effectiveness of
contractor and vendor programs and the implementation of appropriate
corrective action.
* * * * *
(c) The result of the audit, along with recommendations, if any,
must be documented and reported to senior corporate and site
management. The resolution of the audit findings and corrective actions
must be documented. The documents must be retained for three years.
Appendix A to Part 26--Guidelines for Drug and Alcohol Testing
Programs
19. Section 1.1 of Appendix A to part 26 is revised to read as
follows:
1.1 Applicability
(a) These guidelines apply to licensees authorized to operate
nuclear power reactors and licensees who are authorized to possess,
use, or transport formula quantities of strategic special nuclear
material (SSNM).
(b) Licensees may set more stringent cut-off levels than
specified herein or test for substances other than specified herein
and shall inform the Commission of such deviation within 60 days of
implementing such change. Licensees may not deviate from the other
provisions of these guidelines without the written approval of the
Commission.
(c) Only laboratories which are HHS-certified are authorized to
perform urine drug testing for NRC licensees, vendors, and licensee
contractors.
20. Section 1.2 of Appendix A to part 26 is amended by removing
all definitions except chain-of-custody, collection site, and
collection site person, adding the definition of limit of detection
LOD, and revising the introductory text to read as follows:
1.2 Definitions
In addition to the definitions contained in Sec. 26.3, the
following definitions apply:
* * * * *
Limit of Detection (LOD) means the lowest concentration of an
analyte that an analytical procedure can reliably detect, which
should be significantly lower than the established cut-off levels.
21. In section 2.1 of Appendix A to part 26, paragraphs (a),
(b), and (e) are revised to read as follows:
2.1 The Substances
(a) Licensees shall, as a minimum, test for marijuana, cocaine,
opiates, amphetamines, phencyclidine, and alcohol for pre-access,
for-cause, random, follow-up, and return-to-duty tests.
(b) Licensees may test for any illegal drugs and may consider
any detected drugs or metabolites when determining appropriate
action during a for-cause test or analysis of any specimen suspected
of being adulterated or diluted (in vivo or in vitro), substituted,
or tampered with by any other means.
* * * * *
(e) This section does not prohibit procedures reasonably
incident to analysis of a specimen for controlled substances (e.g.,
determination of pH or tests for specific gravity, creatinine
concentration, or presence of adulterants).
22. In section 2.2 of Appendix A to part 26, paragraphs (a), the
introductory text to paragraph (d), (d)(2) and (d)(4) are revised to
read as follows:
2.2 General Administration of Testing
(a) Use of a chain-of-custody form. The original must accompany
the specimen to the HHS-certified laboratory. A copy must accompany
any split specimen. The form must be a record on which is retained
identity data (or codes) on the individual providing the specimen
and information on the specimen collection process and transfers of
custody of the specimen. Chain-of-custody forms related to
determinations of violations of the FFD policy must be retained for
a period of at least five years following termination of the
individual's unescorted access authorization as required by
Sec. 26.71(b), or the completion of all legal proceedings related to
a positive test, whichever is later. Chain-of-custody forms
recording specimens with negative test results and no FFD violations
or anomalies may be destroyed after appropriate summary information
has been recorded for program administration purposes.
* * * * *
(d) Written procedures, instructions, and training must be
provided as follows:
* * * * *
(2) A non-medical collection site person shall receive training
in compliance with this appendix and shall demonstrate proficiency
in the application of this appendix before serving as a collection
site person. A medical professional, technologist, or technician
licensed or otherwise approved to practice in the jurisdiction in
which collection occurs may serve as a collection site person if
that person is provided the instructions described in section
2.2(d)(3) of this appendix and performs collections in accordance
with those instructions.
* * * * *
(4) The option to provide a blood specimen for the purposes of
obtaining additional information that could be considered during an
appeal pursuant to Sec. 26.28 following a positive confirmatory
breath test must be specified in the written instructions provided
to individuals tested.
23. Section 2.3 of Appendix A to part 26 is revised to read as
follows:
2.3 Preventing Subversion of Testing
Licensees shall carefully select and monitor persons responsible
for administering the testing program (e.g., collection site
persons, on-site testing facility technicians, medical review
officers, and those selecting and notifying personnel to be tested),
based upon the highest standards for honesty and integrity, and
shall implement measures to ensure that these standards are
maintained. At a minimum, these measures must ensure that the
integrity of such persons is not compromised or subject to efforts
to compromise due to personal relationships with any individuals
subject to testing. At a minimum:
(1) Supervisors, co-workers, and relatives of the individual
being tested shall not perform any collection, assessment, or
evaluation procedures.
(2) Appropriate background checks and psychological evaluations
of the FFD program personnel specified in Sec. 26.2(a) must be
completed before assignment of tasks directly associated with the
licensee's administration of the program, and must be conducted at
least once every five years.
(3) Persons, specified in Sec. 26.2(a), responsible for
administering the testing program shall be subjected to a behavioral
[[Page 21140]]
observation program designed to assure that they continue to meet
the highest standards for honesty and integrity.
(4) FFD program personnel, specified in Sec. 26.2(a),
responsible for the administration of testing must be subject to
drug and alcohol testing as specified in Sec. 26.24(a). Fitness-for-
duty program personnel shall be tested by personnel independent of
the administration of the FFD program to the extent practicable.
24. In section 2.4 of Appendix A to part 26, paragraphs (d),
(f), the introductory text of paragraph (g), (g)(4), (5), (9)
through (11), (13) through (15), (18) through (20), (23) through
(25), and (27), (h), (i) and (j) are revised to read as follows:
2.4 Specimen Collection Procedures.
* * * * *
(d) ``Chain-of-Custody.'' Licensee chain-of-custody forms must
be properly executed by authorized collection site personnel upon
receipt of specimens. Handling and transportation of urine and blood
specimens from one authorized individual or place to another must
always be accomplished through chain-of-custody procedures. The
signature of the person (courier) picking up the specimen being
shipped to the HHS-certified laboratory does not have to be included
on the chain-of-custody form as long as specimens are sealed in
tamper-evident containers and there is a tracking system that
identifies the courier company conveying the specimens to the
laboratory, includes a shipment billing or control number, and
requires the signature of the courier. Every effort must be made to
minimize the number of persons handling the specimens.
* * * * *
(f) ``Privacy.'' Procedures for collecting urine specimens must
allow individual privacy unless there is reason to believe that a
particular individual may alter or substitute the specimen to be
provided. For purposes of this appendix the following circumstances
are the exclusive grounds constituting a reason to believe that the
individual may alter or substitute a urine specimen:
(1) The individual has presented, at this or any previous
collection, a urine specimen that fails to meet the standards for an
acceptable specimen as provided in paragraph (g)(15) of this
section, or the specimen is determined to be of questionable
validity under the provisions of section 2.7 (e) of this
appendix.
(2) The individual has presented a urine specimen that falls
outside the normal temperature range, and the individual declines to
provide a measurement of oral body temperature by sterile
thermometer, as provided in paragraph (g)(15) of this section, or
the oral temperature does not equal or exceed that of the specimen.
(3) The last urine specimen provided by the individual (i.e., on
a previous occasion) was determined to have a specific gravity of
less than 1.003 or a creatinine concentration below .2 g/L.
(4) The collection site person observes conduct clearly and
unequivocally indicating an attempt to substitute or adulterate the
specimen.
(5) The individual has previously been determined to have used a
substance inappropriately or without medical authorization and the
particular test is being conducted as a part of a rehabilitation
program or on return to service after evaluation and/or treatment
for a confirmed positive test result.
(g) ``Integrity and Identity of Specimens.'' Licensees shall
take precautions to ensure that a urine specimen is not adulterated,
diluted, or tampered with during the collection procedure, that a
surrogate specimen is not provided, that a blood specimen or breath
exhalent tube cannot be substituted or tampered with, and that the
information on the specimen container and in the chain-of-custody
form can identify the individual from whom the specimen was
collected. The following minimum precautions must be taken to ensure
that authentic specimens are obtained and correctly identified:
* * * * *
(4) After the individual has been positively identified, the
collection site person shall ask the individual to sign a consent-
to-testing form. The individual shall not be required to list
prescription medications or over-the-counter preparations that he or
she can remember using.
(5) The collection site person shall ask the individual to
remove any unnecessary outer garments such as a coat or jacket that
might conceal items or substances that could be used to tamper with
or adulterate the individual's urine specimen. The collection site
person shall ensure that all personal belongings such as a purse or
briefcase remain with the outer garments outside of the room in
which the urine specimen is collected. The individual may retain his
or her wallet.
* * * * *
(9) The collection site person shall note any unusual behavior
or appearance on the chain-of-custody form.
(10) In the exceptional event that a designated collection site
is inaccessible and there is an immediate requirement for urine
specimen collection (e.g., an accident investigation), a public or
on-site rest room may be used according to the following procedures.
A collection site person of the same gender as the individual shall
accompany the individual into the rest room which shall be made
secure during the collection procedure. If practicable, a toilet
bluing agent must be placed in the bowl and any accessible toilet
tank. The collection site person shall remain in the rest room, but
outside the stall, until the specimen is collected. If no bluing
agent is available to deter specimen dilution, the collection site
person shall instruct the individual not to flush the toilet until
the specimen is delivered to the collection site person. After the
collection site person has possession of the specimen, the
individual will be instructed to flush the toilet and to participate
with the collection site person in completing the chain-of-custody
procedures. If a collection site person of the same gender is not
available, the licensee shall select a same gender person to
accompany the individual. This person shall be briefed on relevant
collection procedures.
(11) Upon receiving a urine specimen from the individual, the
collection site person shall determine that it contains a quantity
of urine sufficient to meet specific licensee testing program
requirements. The quantity collected must include at least 30
milliliters for the primary specimen, and a sufficient quantity for
any on-site testing and testing for any additional drugs. Where
collected specimens are split under the provisions of section 2.7(k)
of this appendix, an additional 15 milliliters must be collected.
The total to be collected should be of sufficient quantity for all
analyses and reanalyses and must be predetermined by each licensee.
If there is less than the required quantity of urine in the
container, additional urine must be collected to reach the required
quantity. Each successive void must be collected in a separate
container. (The temperature of any partial specimen in its separate
container must be measured in accordance with paragraph (g)(13) of
this section, and the partial specimens must be inspected and sealed
as described below for a full specimen. Upon obtaining the required
amount, the partial specimens must be combined in one container.)
The individual may be given a reasonable amount of liquid to drink
for this purpose (e.g., normally, an 8 oz. glass of water every 30
minutes, but not to exceed a maximum of 24 oz.). If the individual
fails for any reason to provide a sufficient quantity of urine, the
collection site person shall contact the appropriate authority to
obtain guidance on the action to be taken.
* * * * *
(13) Immediately after the urine specimen is collected, the
collection site person 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 licensee shall determine the temperature range within
which the specimen temperature must fall based on the type of
temperature measuring devices used, and shall clearly specify the
temperature range in its collection procedures. The temperature
range of an acceptable urine specimen must be designated by the
licensee and must be within a band of 3 deg.C/6 deg.F or less,
with a lower limit not lower than 34 deg.C/94 deg.F. The time from
urination to temperature measurement is critical and must in no case
exceed 4 minutes.
(14) Immediately after a urine specimen is collected, the
collection site person shall also inspect the specimen to determine
its color and clarity and look for any signs of contaminants or
adulteration. Any unusual findings must be noted on the chain-of-
custody form.
(15) An acceptable specimen is free of any contaminants, meets
the required quantity of at least 30 ml, and is within the
acceptable temperature range and not less than 34 deg.C/94 deg.F.
(i) An individual may volunteer to have his or her oral
temperature taken to provide evidence to counter the reason to
believe the individual may have altered or substituted the specimen
caused by the specimen's temperature falling outside the prescribed
range.
[[Page 21141]]
(ii) If there is a reason to believe that the individual may
have altered or substituted the specimen because one or more of the
acceptance criteria is not met or there is other reason to believe
that the individual is attempting to subvert the testing process,
another specimen must be collected immediately under direct
observation of a same gender collection site person. If a collection
site person of the same gender is not available, the licensee shall
select a same gender observer. The same measurements must be
performed on the second specimen, and both specimens must be
forwarded to the laboratory for testing.
* * * * *
(18) Alcohol breath tests must be performed by using evidential-
grade equipment as specified in section 2.7(o)(3) of this appendix.
The equipment must be operated in accordance with the manufacturer's
instructions by individuals trained and proficient in the use of the
equipment. The screening test consists of analyzing two breath
specimens on the same piece of equipment. If there is reason to
believe a source of alcohol in the mouth exists (e.g., breath
freshener or stomach contents) and the testing device does not have
built-in protection for the condition, the collection of the first
screening breath specimen must be delayed 15 minutes to allow for
dissipation of the material. If the analysis of the first breath
specimen is essentially zero (less than 0.01 percent BAC), the test
is considered negative and no further testing is required. For each
individual whose first screening breath specimen is at or above 0.01
percent BAC, a second breath specimen is to be collected and
compared after two minutes but no later than 10 minutes after the
first specimen is collected. If the two specimens are within plus or
minus 10 percent of the average of the two measurements, then the
test result is considered accurate. If the tests of the two
specimens are not accurate, the series of two breath tests must be
repeated on another evidential-grade breath analysis device ensuring
that the plus or minus 10 percent accuracy is achieved. If the
result of this screening test is greater or equal to 0.02 percent
BAC, a confirmatory test is to be accomplished. The confirmatory
test is a repeat of the screening test procedure done on another
evidential-grade breath analysis device.
(19) If the alcohol breath tests indicate that the individual is
positive for a BAC at or above the 0.04 percent cut-off level or
that the individual may have been positive for a BAC at or above the
0.04 percent cut-off level during any scheduled working tour (i.e.,
has a confirmatory test result between 0.02 percent BAC and 0.04
percent BAC), the individual may request a blood test, at his or her
discretion, for the purposes of obtaining additional information
that could be considered during an appeal. The blood specimen should
be drawn immediately, if possible. If a blood specimen cannot be
drawn immediately, the procedure for calculating a BAC level from
delayed collection of breath specimens and the extrapolation of BAC
results (as per section 26.24(h) and described in section 2.9(i) of
this appendix) must be followed for the blood specimen. All vacuum
tube and needle assemblies used for blood collection must be
factory-sterilized. The collection site person shall ensure that
they remain properly sealed until used. Antiseptic swabbing of the
skin must be performed with a nonethanol antiseptic. Sterile
procedures must be followed when drawing blood and transferring the
blood to a storage container; in addition, the container must be
sterile and sealed.
(20) Both the individual being tested and the collection site
person shall keep urine and blood specimens in view at all times
before their being sealed and labeled. If a urine specimen is split
(as described in section 2.7(k)) and if any specimen is transferred
to a second container, the collection site person shall request the
individual to observe the splitting of the urine sample or the
transfer of the specimen and the placement of the tamper-evident
seal over the container caps and down the sides of the containers.
* * * * *
(23) The individual shall initial the identification labels on
the specimen bottles for the purpose of certifying that it is the
specimen collected from him or her. The specimen bottles must be
securely sealed to prevent undetected tampering. The individual must
also be asked to read and sign a statement on the chain-of-custody
form certifying that the specimens identified as having been
collected from him or her are in fact the specimens he or she
provided.
(24) Agreement of the MRO, other designated medical
professional, or a higher level supervisor of the collection site
person, must be obtained in advance of each decision to obtain a
urine specimen under direct observation as specified in paragraph
(g)(15) of this section.
(25) The collection site person shall complete the chain-of-
custody forms for both the primary specimen and the split specimen,
if collected, and shall certify proper completion of the collection.
* * * * *
(27) While any part of the above chain-of-custody procedures is
being performed, it is essential that the specimens and custody
documents be under the control of the involved collection site
person. The collection site person must not leave the collection
site in the interval between presentation of the specimen by the
individual and securement of the specimens with identifying labels
bearing the individual's specimen identification numbers and seals
initialed by the individual. If the involved collection site person
leaves his or her work station momentarily, the sealed specimens and
chain-of-custody forms must be taken with him or her or must be
secured. If the collection site person is leaving for an extended
period of time, the specimens must be packaged for transfer to the
laboratory before he or she leaves the collection site.
(h) ``Collection Control.'' To the maximum extent possible,
collection site personnel must keep the individual's specimen
containers within sight both before and after the individual has
urinated or provided a blood specimen. After the specimen is
collected and whenever urine specimens are split, they must be
properly sealed and labeled to prevent undetected tampering. The
collection site person shall sign or initial and date the specimen
seal. A chain-of-custody form must be used for maintaining control
and accountability of each specimen including split specimens from
the point of collection to final disposition of the specimen. The
date and purpose must be documented on the chain-of-custody form
each time a specimen is handled or transferred, and every individual
in the chain of custody must be identified. Every effort must be
made to minimize the number of persons handling specimens.
(i) ``Specimen Preparation and Transportation to Laboratory or
Testing Facility.'' Collection site personnel shall arrange to
transfer the collected specimens to the drug testing laboratory or
licensee testing facility. To minimize false negative results from
specimen degradation, specimens must be sent to the HHS-certified
laboratory as soon as reasonably possible but in no case should the
time between specimen shipment and receipt of the specimen at the
HHS-certified laboratory exceed 48 hours, or the time between
shipment and screening test at the HHS-certified laboratory exceed
72 hours. Collected urine specimens must be shipped to the HHS-
certified laboratory, or cooled to not more than 6 degrees
centigrade (42.8 deg.F), within 6 hours of collection. Sealed and
labeled specimen bottles being transferred from the collection site
to the drug testing laboratory must be placed in a second, tamper-
evident shipping container which must be 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. The collection site personnel shall ensure that
the chain-of-custody documentation is attached to each urine
specimen bottle.
(j) ``Failure to Cooperate.'' If the individual refuses to
cooperate with the urine collection or breath analysis process
(e.g., refusal to provide a complete specimen, complete paperwork,
initial specimen), then the collection site person shall inform the
appropriate authority and shall document the non-cooperation on the
specimen chain-of-custody form. The failure to cooperate must be
reported immediately to the Medical Review Officer, the FFD Program
Manager, or to other management having a need to know, as
appropriate, for further action. The provision of a blood specimen
for use in an appeal of a positive breath test for alcohol must be
entirely voluntary, and must be at the individual's option.
25. In section 2.5 of Appendix A to part 26, paragraph (a)(5) is
revised to read as follows:
2.5 HHS-Certified Laboratory Personnel
(a) * * *
(5) This individual shall be responsible for the laboratory's
having a procedure manual which is complete, up-to-date, available
for personnel performing tests, and followed by those personnel. The
procedure manual must be reviewed, signed, and dated by this
[[Page 21142]]
responsible individual whenever procedures are first placed into use
or changed or when a new individual assumes responsibility for
management of the laboratory. Copies of all procedures and dates on
which they are in effect must be maintained. (Specific contents of
the procedure manual are described in section 2.7(p) of this
appendix).
* * * * *
26. In section 2.6 of Appendix A to part 26, paragraph (a) is
revised to read as follows:
2.6 Licensee Testing Facility Personnel
(a) ``Day-to-Day Management of Operations.'' Any licensee
testing facility shall have an individual to be responsible for day-
to-day operations and to supervise the testing technicians. This
individual(s) shall have at least a bachelor's degree in the
chemical or biological sciences, medical technology, or equivalent.
He or she shall have training and experience in the theory and
practice of the procedures used in the licensee testing facility,
resulting in his or her thorough understanding of quality control
practices and procedures; the review, interpretation, and reporting
of test results; maintenance of chain of custody; and proper
remedial actions to be taken in response to detecting aberrant test
or quality control results.
* * * * *
27. Section 2.7 of Appendix A to part 26, paragraphs (e) through
(o) are redesignated (f) through (p), new paragraphs (e), (f)(3),
(g)(6), and (p)(6) are added, and paragraphs (b)(1), (c), (d),
(f)(1), (g) (1), (2), (3), and (5), (h) (1), (2), (3), (5), and (6),
(i), (j), (k), (m)(2), (n), and (p) (1), (2), and (3)(ii) are
revised to read as follows:
2.7 Laboratory and Testing Facility Analysis Procedures
* * * * *
(b) ``Receiving.'' (1) When a shipment of specimens is received,
laboratory and the licensee's testing facility personnel shall
inspect each package for evidence of possible tampering and compare
information on specimen containers within each package to the
information on the accompanying chain-of-custody forms. Any direct
evidence of tampering or discrepancies in the information on
specimen containers and the licensee's chain-of-custody forms must
be reported by the HHS-certified laboratory within 24 hours to the
licensee and must be noted on the laboratory's chain-of-custody form
which must accompany the specimens while they are in the
laboratory's possession. Indications of tampering with specimens at
a testing facility operated by a licensee must be reported within 8
hours to senior licensee management.
* * * * *
(c) ``Short-Term Refrigerated Storage.'' Specimens that do not
receive a screening test and, if appropriate, a confirmatory test
within one day of arrival at the HHS-certified laboratory, or are
not shipped within 6 hours of collection from the licensee's
collection or testing facility, as well as any retained split
specimens, must be placed in secure refrigeration units or other
means of securely maintaining the specimens in a chilled condition
until testing or shipment. Temperatures must not exceed 6 deg.C/43
deg.F. Contingency measures must be available to maintain the
specimens in a chilled state in case of prolonged power failure.
(d) ``Specimen Processing.'' Urine specimens identified as
unconfirmed positive or as questionable for adulteration or dilution
by a licensee's testing facility must be shipped to an HHS-certified
laboratory for testing. Laboratory facilities for drug testing will
normally process urine specimens by grouping them into batches. The
number of specimens in each batch may vary significantly depending
on the size of the laboratory and its workload. When conducting
either screening or confirmatory tests at either the licensee's
testing facility or an HHS-certified laboratory, every batch must
contain an appropriate number of standards for calibrating the
instrumentation and a minimum of 10 percent controls. Both quality
control and blind performance test specimens must appear as ordinary
specimens to laboratory analysts. Special processing may be
conducted to analyze specimens suspected of being adulterated or
diluted (including hydration). Any evidence of adulteration or
dilution, and any detected trace amounts of drugs or metabolites,
must be reported to the Medical Review Officer. The Medical Review
Officer shall report any adulteration or dilution evidence
(excluding hydration resulting from an acceptable reason) to
management immediately.
(e) ``Determining Specimen Validity.'' Specimens must be tested
at a licensee's testing facility, if the licensee conducts screening
tests, and at an HHS-certified laboratory to determine their
validity and to detect evidence of adulteration or dilution. At a
minimum, such testing must include analysis of specific gravity (SG)
before being subjected to screening testing. Devices used to
determine validity of the specimen must be accurate and not
contaminate the specimen. A specimen acceptable for testing using
the cut-off levels in paragraphs (f)(1) and (g)(2) of this section
has a specific gravity greater than 1.003 and is free of detectable
adulterants. Specimens determined to be of questionable validity
that show evidence of dilution must be subject to both screening and
confirmation testing using the limit of detection (LOD) that the
laboratory is capable of performing. If the specimen's specific
gravity (SG) is less than 1.001, or if there is reason to believe
that the specimen has been adulterated, the laboratory need not
conduct LOD testing and must report the possibly adulterated or
diluted condition to the Medical Review Officer. When the MRO cannot
determine if the specimen is valid or invalid, another specimen must
be collected as soon as possible under the provisions of section
2.4(f) of this appendix.
(f) `` Onsite and Laboratory Screening Tests.''
(1) For the analysis of urine specimens, any screening test
performed by a licensee's testing facility and the screening test
performed by an HHS-certified laboratory must use an immunoassay
which meets the requirements of the Food and Drug Administration for
commercial distribution. The screening test of breath for alcohol
performed at the collection site must use a breath measurement
device which meets the requirements of paragraph (p)(3) of this
section. The following initial cut-off levels must be used when
screening specimens to determine whether they are negative for the
indicated substances:
Screening Test Cut-Off Level
(ng/ml)
------------------------------------------------------------------------
------------------------------------------------------------------------
Marijuana metabolites..................... 50.
Cocaine metabolites....................... 300.
Opiate metabolites \1\.................... 300.
Phencyclidine............................. 25.
Amphetamines.............................. 1,000.
Alcohol \2\............................... 0.04% BAC.
------------------------------------------------------------------------
\1\ 25 ng/ml is immunoassay specific for free morphine.
\2\ Percent, by weight, of alcohol in a person's blood shall be based
upon grams of alcohol per 100 milliliters of blood or grams of alcohol
per 210 liters of breath.
In addition, licensees may specify more stringent cut-off levels. In
such cases, the results of HHS screening tests must be reported for
both levels. Only the more stringent tests need be conducted, and
the results for the cut-off levels above may be calculated.
* * * * *
(3) Multiple screening tests (also known as rescreening) for the
same drug class may be performed on:
(i) Unconfirmed positive specimens (e.g., an unconfirmed
positive for amphetamines) only when needed to reduce the effect of
possible cross reactivity due to structural analogs;
(ii) Those specimens where a valid analytical result cannot be
obtained using one particular immunoassay technique due to
interference in the assay (e.g., prescription medication); or
(iii) Unconfirmed positive specimens that appear to have a high
concentration of drugs or metabolites to determine an appropriate
dilution requirement for GC/MS confirmation analysis.
(g) ``Confirmatory Test.'' (1) Specimens which test negative as
a result of a screening test must be reported as negative to the
licensee and will not be subject to any further testing unless
special processing of the specimen is desired because adulteration
or dilution is suspected.
(2) All urine specimens identified as unconfirmed positive on
the screening test performed by a HHS-certified laboratory must be
confirmed using gas chromatography/mass spectrometry (GC/MS)
techniques at the cut-off values listed in this paragraph for each
drug, or at the cut-off values required by the licensee's unique
program, where differences exist. All confirmations must be made by
quantitative analysis. Concentrations which exceed the linear region
of the standard curve must be documented in the laboratory record as
``greater than highest standard curve value.''
[[Page 21143]]
Confirmatory Test Cut-Off Level
(ng/ml)
------------------------------------------------------------------------
------------------------------------------------------------------------
Marijuana metabolite \1\.................. 15.
Cocaine metabolite \2\.................... 150.
Opiates: ............................
Morphine................................ 300.
Codeine................................. 300.
Phencyclidine 25.
Amphetamines:........................... ............................
Amphetamine............................. 500.
Methamphetamine \3\..................... 500.
Alcohol \4\............................. 40.04% BAC.
------------------------------------------------------------------------
\1\ 1Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Benzoylecgonine.
\3\ Specimen must also contain amphetamine at a concentration 200 ng/ml.
\4\ Percent, by weight, of alcohol in a person's blood shall be based
upon grams of alcohol per 100 milliliters of blood or grams of alcohol
per 210 liters of breath.
In addition, licensees may specify more stringent cut-off levels. In
such cases, the results must be reported for both levels. Only the
more stringent tests need be conducted, and the results for the cut-
off levels above may be calculated.
(3) The analytic procedure for analysis of blood specimens
voluntarily provided by individuals testing positive for alcohol on
a breath test must be gas chromatography analysis.
* * * * *
(5) Confirmatory tests for opiates must include a test for 6-
acetylmorphine (AM).
(6) Specimens that have a positive GC/MS test result for
amphetamines must be tested for the d and l isomers. The results of
this additional test must be reported to the MRO. Laboratory quality
control and inspection criteria must be included for this additional
test.
(h) ``Reporting Results.'' (1) The HHS-certified laboratory
shall report test results to the licensee's Medical Review Officer
within 4 working days (6 for suspected amphetamines) after receipt
of the specimen by the laboratory. Before any test result is
reported, the results of screening tests, confirmatory tests, and
quality control data, as applicable, must be reviewed and the test
certified as an accurate report by the responsible individual at the
laboratory. The report must identify the substances tested for,
whether positive or negative; the cut-off(s) for each; the specimen
number assigned by the licensee; any indications of tampering,
adulteration, or dilution that may be present; and the drug testing
laboratory specimen identification number.
(2) The HHS-certified laboratory and any licensee testing
facility shall report as negative all specimens, except suspect
specimens being analyzed under special processing, which are
negative on the screening test or negative on the confirmatory test.
Specimens testing positive on the confirmatory analysis must be
reported positive for a specific substance. Except as provided in
Sec. 26.24(d), unconfirmed positive results of screening testing at
the licensee's testing facility will not be reported to licensee
management. The MRO's staff may perform routine administrative
support functions, including receipt of test results and scheduling
interviews for the MRO.
(3) The Medical Review Officer may routinely obtain from the
HHS-certified laboratory, and the laboratory must provide,
quantitation of test results. The Medical Review Officer may only
disclose quantitation of test results for an individual to licensee
management if required in an appeals process, or to the individual
under the provisions of Sec. 26.29(c). (This does not preclude the
provision of program performance data under the provisions of 10 CFR
26.71(d).) Quantitation of negative tests for urine specimens shall
not be disclosed, except where deemed appropriate by the Medical
Review Officer for proper disposition of the results of tests of
suspect specimens. Alcohol quantitation for a blood specimen must be
provided to licensee management with the Medical Review Officer's
evaluation.
* * * * *
(5) The laboratory shall retain the original chain-of-custody
form and must send only to the Medical Review Officer certified true
copies of the original chain-of-custody form and the test report. In
the case of a laboratory-confirmed positive or special processing of
suspect specimens, the document must be signed by the individual
responsible for day-to-day management of the drug testing laboratory
or the individual responsible for attesting to the validity of the
test reports. Laboratories must retain these documents consistent
with the requirements contained in section 2.2(a) of this appendix.
(6) The HHS-certified laboratory and the licensee's testing
facility shall provide to the licensee official responsible for
coordination of the fitness-for-duty program a monthly statistical
summary of urinalysis and blood testing and shall not include in the
summary any personal identifying information. Initial test data from
the licensee's testing facility and the HHS-certified laboratory,
and confirmation data from HHS-certified laboratories must be
included for test results reported within that month. Normally this
summary must be forwarded from HHS-certified laboratories by
registered or certified mail and from the licensee's testing
facility not more than 14 calendar days after the end of the month
covered by the summary. The summary must contain the following
information:
(i) Screening Testing:
(A) Number of specimens received;
(B) Number of specimens reported out; and
(C) Number of specimens screened positive for:
(1) Marijuana metabolites;
(2) Cocaine metabolites;
(3) Opiate metabolites;
(4) Phencyclidine;
(5) Amphetamines; and
(6) Alcohol.
* * * * *
(i) ``Long-Term Storage.'' Long-term frozen storage (-20 deg.C
or less) ensures that any urine specimens that have been associated
with personnel actions will be available for any necessary retest
during administrative or disciplinary proceedings. Unless otherwise
authorized in writing by the licensee, HHS-certified laboratories
shall retain and place in properly secured long-term frozen storage
for a minimum of 1 year all specimens that have been confirmed
positive, or that have been adulterated or diluted. Within this 1-
year period, a licensee or the NRC may request the laboratory to
retain the specimen for an additional period of time. If no such
request is received, the laboratory may discard the specimen after
the end of 1 year. The laboratory must maintain any specimens under
legal challenge for an indefinite period. Any split specimens
retained by the licensee must be transferred into long-term storage
upon determination by the Medical Review Officer that the specimen
has a laboratory confirmed positive test.
(j) ``Retesting Specimens.'' Because some analytes deteriorate
or are lost during freezing and/or storage, quantitation for a
retest is not subject to a specific cut-off requirement but must
provide data sufficient to confirm the presence of the drug or
metabolite. For the retesting of specimens that have been determined
to have been adulterated or diluted, the retest need only confirm
that the specimen is not valid.
(k) ``Split Specimens.'' Urine specimens may be split, at the
licensee's discretion, into two parts at the collection site. One
half of such specimens (hereafter called the primary specimen) must
be analyzed by the licensee's testing facility or the HHS-certified
laboratory for the licensee's purposes as described in this
appendix. The other half of the specimen (hereafter called the split
specimen) may be withheld from transfer to the laboratory, sealed,
and stored in a secure manner by the licensee until all processing
of the primary specimen has been completed. If the primary specimen
is determined to be negative and free of any evidence of subversion,
the split specimen in storage may be destroyed. If the unconfirmed
positive result of a screening test has been confirmed, or if the
primary specimen is determined to have been subject to adulteration,
dilution, or other means of testing subversion, the tested
individual may request in a timely manner (as established by the
licensee, but not to be restricted to less than 72 hours from the
time of the individual's notification of the screening test result)
that the split specimen be tested. The individual must be informed
of this option. The split specimen must be forwarded on the day of
the request to another HHS-certified laboratory that did not test
the primary specimen. The chain-of-custody and testing procedures to
which the split specimen is subject must be the same as those used
to test the primary specimen and must meet the standards for
retesting specimens. In other words, the quantification of the
result is not subject to a specific cut-off requirement but must
provide data sufficient to confirm the presence of the drug or
metabolite (section 2.7(j) of this appendix). The quantitative
results of any second testing process shall be made available to the
Medical Review Officer and to the individual tested. Except as noted
in this section, all other requirements of this appendix applicable
to primary specimens shall also be applicable to split specimens.
* * * * *
[[Page 21144]]
(m) ``Laboratory Facilities.''
* * * * *
(2) HHS-certified laboratories must have the capability, at the
same laboratory premises, of performing screening and confirmatory
tests for each drug and drug metabolite for which service is offered
and for blood analysis for alcohol content (BAC). Any licensee
testing facilities must have the capability, at the same premises,
of performing screening tests for each drug and drug metabolite for
which testing is conducted. Breath tests for alcohol may be
performed at the collection site.
(n) ``Inspections and Audits.'' The NRC and any licensee
utilizing an HHS-certified laboratory reserves the right to inspect
or audit the laboratory at any time. Licensee contracts with HHS-
certified laboratories for drug testing and analyses of blood for
alcohol content (BAC), as well as contracts for collection site
services, must permit the NRC and the licensee to conduct
unannounced inspections and audits and to obtain all information and
documentation reasonably relevant to the inspections and audits.
Licensee contracts with HHS-certified laboratories must also provide
the licensee and the NRC with the ability to obtain copies of any
documents, including reviews and inspections pertaining to the
laboratory's certification by HHS, and any other data that may be
needed to assure that the laboratory is performing its testing and
quality control functions properly and that laboratory staff and
procedures meet applicable requirements. Annual licensee inspections
and audits of HHS-certified laboratories must include review of
inspection reports made under the HHS-certification program but need
not duplicate areas covered by the HHS inspection. In addition,
before the award of a contract, the licensee shall carry out pre-
award inspections and evaluation of the procedural aspects of the
laboratory's drug testing operation. If an HHS-certified laboratory
loses its certification, in whole or in part, a licensee is
permitted to immediately use an HHS-certified laboratory that has
been audited by another NRC licensee having a compatible drug panel
and cut-off standards. The licensee shall audit the newly contracted
HHS-certified laboratory within three months. The NRC reserves the
right to inspect a licensee's testing facility at any time.
* * * * *
(p) ``Additional Requirements for HHS-Certified Laboratories and
Licensees' Testing Facilities.''
(1) ``Procedure manual.'' Each laboratory and licensee's testing
facility shall have a procedure manual which includes the principles
of each test, preparation of reagents, standards and controls,
calibration procedures, derivation of results, linearity of methods,
sensitivity of the methods, cut-off values, mechanisms for reporting
results, controls, criteria for unacceptable specimens and results,
remedial actions to be taken when the test systems are outside of
acceptable limits, reagents and expiration dates, and references.
Copies of all procedures and dates on which they are in effect must
be maintained as part of the manual. Each HHS-certified laboratory
shall retain a copy of its latest procedure manual as a record until
at least 2 years after it is no longer under contract to an NRC
licensee to test specimens of urine for drugs. Each licensee shall
retain a copy of its latest procedure manual as a record until it is
no longer conducting on-site testing of specimens of urine for
drugs. Superseded material must be retained for at least three
years.
(2) ``Standards and controls.'' HHS-certified laboratory
standards shall be prepared with pure drug standards which are
properly labeled as to content and concentration. The standards must
be labeled with the following dates: when received; when prepared or
opened; when placed in service; and expiration date. All standards
used to calibrate alcohol breath analysis equipment and equipment
used at licensees' testing facilities for conducting screening tests
must be current and valid for their purpose.
(3) ``Instruments and equipment.''
* * * * *
(ii) Alcohol breath analysis equipment must be an evidential-
grade breath alcohol analysis device of a brand and model that
conforms to National Highway Traffic Safety Administration (NHTSA)
standards (49 FR 48855; December 14, 1984 or 58 FR 48705; September
17, 1993) and to any applicable State statutes.
* * * * *
(6) ``Restrictions.'' The laboratory shall not enter into any
relationship with a licensee's MRO that may be construed as a
potential conflict of interest or derive any financial benefit by
having a licensee use a specific MRO.
28. In section 2.8 of Appendix A to part 26, paragraphs (a),
(b), (c), and (e) are revised, and new paragraph (f) is added to
read as follows:
2.8 Quality Assurance and Quality Control
(a) ``General.'' HHS-certified laboratories and the licensee's
testing facility shall have a quality assurance program which
encompasses all aspects of the testing process including, but not
limited to, specimen acquisition, chain of custody, security,
reporting of results, screening and confirmatory 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 testing for drugs.
(b) ``Licensee's Testing Facility Quality Control Requirements
for Screening Tests.'' Because all unconfirmed positive licensee
facility screening tests for drugs are forwarded to an HHS-certified
laboratory for screening and confirmatory testing when appropriate,
the NRC does not require licensees to assess their testing
facility's false positive rates for drugs. To ensure that the rate
of false negative tests is kept to the minimum that the immunoassay
technology supports, licensees shall perform an immunoassay test on
all blind performance test specimens and submit these and a sampling
of specimens screened as negative from every test run to the HHS-
certified laboratory. The results reported by the certified
laboratory must be evaluated and appropriate corrective actions
taken. The manufacturer-required performance tests of the breath
analysis equipment used by the licensee must be conducted as set
forth in the manufacturer's specifications.
(c) ``Laboratory Quality Control Requirements for Screening
Tests at HHS-Certified Laboratories.'' (1) Each analytical run of
specimens to be screened must include:
(i) Urine specimens certified to contain no drug;
(ii) Urine specimens fortified with known standards; and
(iii) Positive controls with the drug or metabolite at or near
the threshold (cut-off).
(2) In addition, with each batch of specimens, a sufficient
number of standards must be included to ensure and document the
linearity of the assay method over time in the concentration area of
the cut-off. After acceptable values are obtained for the known
standards, those values will be used to calculate specimen data.
Implementation of procedures to ensure that carryover does not
contaminate the testing of an individual's specimen must be
documented. A minimum of 10 percent of all test specimens must be
quality control specimens. Laboratory quality control specimens
prepared from spiked urine specimens of determined concentration,
must be included in the run and should appear as normal specimens to
laboratory analysts. One percent of each run, with a minimum of at
least one specimen, must be the laboratory's own quality control
specimens.
* * * * *
(e) ``Licensee Blind Performance Test Procedures.'' (1)
Licensees shall only purchase blind quality control materials that:
(i) Have been certified by immunoassay and GC/MS; and
(ii) Have stability data which verify performance of those
materials over time.
(2) During the initial 90-day period of any contract with an
HHS-certified laboratory (not including rewritten or renewed
contracts), each licensee shall submit blind performance test
specimens to the laboratory within the amount of at least 20 percent
of the total number of specimens submitted (up to a maximum of 100
specimens) or 30 blind performance test specimens, whichever is
greater. Following the initial 90-day period, a minimum of 3 percent
of all specimens (to a maximum of 25) or 10 blind performance test
specimens, whichever is greater, must be submitted per quarter.
Licensees should make an attempt to submit blind performance test
specimens during the initial 90-day period and per quarter
thereafter at a frequency that corresponds with the submission
frequency for other specimens.
(3) Approximately 50 percent of the blind performance test
specimens must be blank (i.e., certified to contain no drug) and the
remaining specimens must be positive for one or more drugs per
specimen in a distribution such that all the drugs for which the
licensee is testing are included in approximately equal frequencies
of challenge. The positive specimens must be spiked only with those
drugs for which the licensee is testing. In addition, 10 percent of
the positive blind specimens must be
[[Page 21145]]
appropriately adulterated or diluted and ``spiked'' to 60 percent of
the cut-off value to challenge the laboratory's ability to determine
specimen validity, as required by section 2.7 (e) of this appendix.
(f) ``Investigation of Errors and Other Matters.''
(1) The licensee shall investigate any 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 reflect adversely on the integrity of the testing process. The
investigation must determine relevant facts and identify the root
cause(s) of the testing or process error when possible. The licensee
and the laboratory shall take action to correct the cause of any
errors or the unsatisfactory performance that are within their
control. A record must be made and retained for a minimum of three
years of the investigative findings and the corrective action taken,
and, where applicable, that record must be dated and signed by the
individuals responsible for the day-to-day management and operation
of the HHS-certified laboratory. The licensee shall submit to the
NRC a report of any incident and action taken or planned within 30
days of completion of the investigation. The NRC shall ensure
notification of the finding to HHS.
(2) Should a false positive error occur on a blind performance
test specimen or on a regular test specimen, the licensee shall
promptly notify the NRC. The licensee 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 the
error could have been systematic, the licensee may also require
review and reanalysis of previously run specimens.
(3) Should a false positive error be determined to be technical
or methodological, the licensee shall instruct the laboratory to
submit to it all quality control data from the batch of specimens
which included any false positive specimen. In addition, the
licensee shall require the laboratory to retest all specimens
analyzed positive for that drug or metabolite 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 individual responsible for day-to-day
management of the laboratory's substance testing program. The
licensee and the NRC may require an on-site review of the laboratory
which may be conducted unannounced during any hours of operation of
the laboratory. Based on information provided by the NRC, HHS has
the option of revoking or suspending the laboratory's certification
or recommending that no further action be taken if the case is one
of less serious error in which corrective action has already been
taken, thus reasonably assuring that the error will not occur again.
29. Section 2.9 of Appendix A to part 26 is revised to read as
follows:
2.9 Reporting and Review of Results
(a) ``Medical Review Officer shall review results.'' An
essential part of a licensee's testing program is the final review
of results. A laboratory confirmed positive test result does not
automatically identify a nuclear power plant worker as having used
substances in violation of the NRC's regulations or the licensee's
company policies. An individual with a detailed knowledge of
possible alternate medical explanations is essential to the review
of results. This review must be performed by the Medical Review
Officer before the transmission of results to licensee management
officials.
(b) ``Medical Review Officer--qualifications and
responsibilities.'' The Medical Review Officer shall be a licensed
physician with knowledge of substance abuse disorders. The MRO may
be a licensee or contract employee. However, the MRO shall not be an
employee or agent of or have any financial interest in a laboratory
or a contracted operator of an on-site testing facility whose drug
testing results the MRO is reviewing for the licensee. Additionally,
the MRO shall not derive any financial benefit by having the
licensee use a specific drug testing laboratory or on-site testing
facility operating contractor or have any agreement with such
parties that may be construed as a potential conflict of interest.
The role of the Medical Review Officer is to review and interpret
laboratory confirmed positive test results obtained through the
licensee's testing program and to identify evidence of subversion of
the testing process. The MRO is also responsible for identifying
issues associated with the collection and testing of specimens, and
advising and assisting management in the planning and oversight of
the overall FFD program. In carrying out this responsibility, the
Medical Review Officer shall examine alternate medical explanations
for any laboratory confirmed positive test result (this does not
include confirmation of blood alcohol levels obtained through the
use of a breath alcohol analysis device). This action could include
conducting a medical interview with the individual, review of the
individual's medical history, or review of any other relevant
biomedical factors. The Medical Review Officer shall review all
medical records made available by the tested individual when a
laboratory confirmed positive test could have resulted from legally
prescribed medication. The Medical Review Officer shall not consider
the results of tests that are not obtained or processed in
accordance with this appendix, although he or she may consider the
results of tests on 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 appendix.
(c) ``MRO Verification of Positive Test Results.'' Before making
a final decision to verify a laboratory confirmed positive test
result, the Medical Review Officer shall give the individual an
opportunity to discuss the test result with him or her. Following
verification of a laboratory confirmed positive test result as a
violation of FFD policy, the Medical Review Officer shall, as
provided in the licensee's policy, immediately notify the applicable
employee assistance program and the licensee's management official
empowered to recommend or take administrative action (or the
official's designated agent). Unconfirmed test results must not be
reported except as provided by Sec. 26.24(d).
(d) ``Verification for opiates.'' Before the Medical Review
Officer verifies a laboratory confirmed positive result as a
violation of FFD policy and the licensee takes action for opiates,
he or she shall determine that there is reasonable and substantial
clinical evidence--in addition to the urine test--of unauthorized
use of any opium, opiate, or opium derivative (e.g., morphine/
codeine). Clinical evidence may include substantial evidence of a
significant lack of reliability or trustworthiness on the part of
the worker. Clinical signs of abuse include recent needle tracks or
test results that are inconsistent with the ingestion of food or
medication including prescription medications containing opiates
(e.g., 6-AM test); clinical signs of abuse also include behavioral
and psychological signs of acute opiate intoxication or withdrawal.
This requirement does not apply if the GC/MS confirmation testing
for opiates confirms the presence of 6-acetylmorphine.
(e) ``Reanalysis authorized.'' Should any question arise as to
the accuracy or validity of a laboratory confirmed positive test
result, only the Medical Review Officer is authorized to order a
reanalysis of the original specimen and such retests are authorized
only at laboratories certified by HHS. The Medical Review Officer
shall authorize a reanalysis of the original aliquot on timely
request (as established by the licensee, but not to be restricted to
less than 72 hours from the time of the individual's notification of
the laboratory confirmed positive test result) of the individual
tested, and shall also authorize an analysis of any split specimen
stored by or for the licensee under the provisions of section 2.7(k)
of this appendix.
(f) ``Results consistent with responsible substance use.'' If
the Medical Review Officer determines that there is a legitimate
medical explanation for the laboratory confirmed positive test
result, and that the use of the substance 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 there has
not been a violation of licensee policy. The Medical Review Officer
shall report the test result to the licensee as negative. The
Medical Review Officer shall further evaluate the result and medical
explanation to determine if there is a potential risk to public
health and safety of the individual being impaired on duty from the
substance or from the medical condition. If the MRO determines that
such a risk exists, he or she shall conduct a medical determination
of fitness.
(g) ``Medical determination of fitness.'' (1) Occasions when a
medical determination of fitness, as defined in Sec. 26.3, must be
conducted include, but are not limited to, the following:
(i) When an alternative medical explanation explains the test
result but there is a basis for believing impairment on duty could
exist, as described in paragraph (f) of this section;
[[Page 21146]]
(ii) In the evaluation of all for-cause test results;
(iii) Before making return-to-duty recommendations subsequent to
a worker's removal from duty in accordance with Sec. 26.27(b) or the
licensee's fitness-for-duty policy;
(iv) Before an individual being granted unescorted access when a
statement from an individual obtained pursuant to Sec. 26.27(a)
shows a history of substance abuse or record of prior fitness-for-
duty violations; and
(v) If a history of substance abuse is otherwise identified.
(2)(i) If the licensed physician or MRO determines that there is
neither conclusive evidence of a policy violation nor a significant
basis for concern that the individual may be impaired while on duty,
then he or she shall report the result as negative.
(ii) If the licensed physician or MRO determines that there is
not conclusive evidence of a policy violation but that there is a
significant basis for concern that the individual may be impaired
while on duty, then he or she shall report the result as not
representing an FFD violation but as a condition under which the
individual may not be able to safely and competently perform duties.
Because these results should not constitute a violation of the
licensee's policy or the NRC rule, punitive actions under the rule
should not be taken based upon the results. However, the licensed
physician, MRO, or the licensee management personnel who are
empowered to take appropriate actions shall initiate actions to
ensure that any possible limiting condition does not represent a
threat to workplace or public health and safety. When deemed
appropriate, the matter may also be referred to the EAP.
(h) Breath alcohol content indicating a blood alcohol
concentration between 0.02 percent and 0.04 percent must be reported
to the MRO for review and evaluation. The MRO shall determine
whether it is appropriate to extrapolate back in time to estimate
the highest BAC that the worker had while on duty with the
assumption that no alcohol was consumed while on duty. In these
cases, the MRO will calculate a range of possible peak BACs that
could have existed while the worker was on duty and make a
determination whether the result is a confirmed positive test for
alcohol. A similar extrapolation process must be conducted for the
results of an analysis of a blood specimen for alcohol, as provided
by Sec. 26.24(h).
(i) ``Result scientifically insufficient.'' Additionally, the
Medical Review Officer, based on review of inspection reports,
quality control data, multiple specimens, and other pertinent
results, may determine that the result is scientifically
insufficient for further action and declare the test specimen
negative. In this situation, the Medical Review Officer may request
reanalysis of the original specimen before making this decision. The
Medical Review Officer may request that reanalysis be performed by
the same laboratory, or that an aliquot of the original specimen be
sent for reanalysis to an alternate laboratory which is certified in
accordance with the HHS Guidelines. The licensee's testing facility
and the HHS-certified laboratory shall assist in this review process
as requested by the Medical Review Officer by making available the
individual(s) responsible for day-to-day management of the
licensee's test facility, of 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 licensee. The licensee shall
maintain for a minimum of three years, records that summarize any
negative findings based on scientific insufficiency and shall make
them available to the NRC on request, but shall not include any
personal identifying information in such reports.
Appendix A [Amended]
30. Section 3.2 of Appendix A is removed.
31. In section 4.1 of Appendix A to part 26 is revised to read
as follows:
4.1 Use of HHS-Certified Laboratories
(a) Licensees subject to this part and their contractors shall
use only laboratories certified under the HHS ``Mandatory Guidelines
for Federal Workplace Drug Testing Programs'', Subpart C--
``Certification of Laboratories Engaged in Urine Drug Testing for
Federal Agencies,'' (53 FR 11970, 11986-11989) dated April 11, 1988,
and subsequent amendments thereto for screening and confirmatory
testing except for screening tests at a licensee's testing facility
conducted in accordance with Sec. 26.24(d). Information concerning
the current certification status of laboratories is available from:
The Division of Workplace Programs, Substance Abuse and Mental
Health Services Administration, Room 13-A-54, 5600 Fishers Lane,
Rockville, Maryland 20857.
(b) Licensees or their contractors may use only HHS-certified
laboratories that agree to follow the same rigorous chemical
testing, quality control, and chain-of-custody procedures when
testing for more stringent cut-off levels as may be specified by
licensees for the classes of drugs identified in this part, for
analysis of blood specimens for alcohol, and for any other
substances included in licensees' drug panels. Because the HHS-
certification process does not apply to these matters, the
defensibility of such tests depends on appropriate measures by
licensees to assure the reported test results are valid.
(c) All contracts related to this part between licensees and
their contractors and HHS-certified laboratories must require
implementation of all obligations of this appendix applicable to
HHS-certified laboratories.
Dated at Rockville, Maryland, this 29th day of April, 1996.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 96-11046 Filed 5-8-96; 8:45 am]
BILLING CODE 7590-01-P