The complete revision to 10 CFR 26
contains NRC's requirements and standards for the establishment,
implementation, and maintenance of FFD programs. The mandatory
recordkeeping and reporting requirements include provisions
requiring licensees and other entities to develop and maintain
policies and procedures; retain records of training, qualification
and authorization of individuals; retain records related to drug
and alcohol collections and tests; retain other records related to
the collection, testing, and review processes; report FFD program
performance and significant violations, program failures and
testing errors; and retain records related to employee assistance
programs. Records and reports are also required under the proposed
new fatigue management component of the FFD program. The NRC would
use the reports to assess the effectiveness of FFd programs for
those subject to the rule, and to ensure the provisions are
implemented as the NRC intends.
NRC is amending its regulations
for Fitness for Duty(FFD) programs to update these requirements and
enhance consistency with advances in other relevant Federal rules
and guidelines, including the U.S. Department of Health and Human
Services(DHHS) Mandatory Guidelines for Federal Workplace Drug
Testing Programs, and other Federal drug and alcohol testing
programs that impose similar requirements on the private sector.
The amendments require nuclear power plant licensees and other
entities, including facilities possessing Category 1A material, to
strengthen the effectiveness of their FFD programs. In addition,
the amendments require nuclear power plant licensees and other
entities to ensure consistency with the NRCs access authorization
requirements for nuclear power plants. The amendments also require
nuclear power plant licensees to ensure against worker fatigue
adversely affecting public health and safety and the common defense
and security by establishing clear and enforceable requirements for
the management of worker fatigue. The final rule ensures that
individuals who are subject to these regulations are trustworthy
and reliable, as demonstrated by avoiding substance abuse; are not
under the influence of drugs or alcohol while performing their
duties; and are not mentally or physically impaired from any other
cause that would in any way adversely affect their ability to
perform their duties safely and competently. The final rule creates
significantly more detailed requirements pertaining to the FFD
authorization process for individuals to ensure consistency with
the NRCs access authorization requirements for nuclear power
plants established in 10 CFR 73.56, as supplemented by orders to
nuclear power plant licensees dated January 7, 2003. It also
includes more detailed requirements pertaining to the specimen
collection and testing process to increase consistency with other
relevant Federal rules and guidelines, including the DHHS Mandatory
Guidelines for Federal Workplace Drug Testing Programs (DHHS
Guidelines). The final rule includes a new subpart addressing
requirements for HHS-certified laboratories, adds requirements for
confirmatory drug and alcohol testing and verification testing, and
expands and makes more explicit the requirements for licensee
testing facilities. The burden estimate for the final rule captures
significant third-party collections associated with the reporting
and recordkeeping for the drug and alcohol testing activities that
were not captured in the previous rule. Experience from the
implementation of the current FFD rule, information obtained from
stakeholders, and information obtained from sources such as the
DHHS National Laboratory Certification Program has led the NRC to
revise its estimates of the burden of certain activities. The NRC
typically uses a formula to compute other additional cost, which is
recordkeeping burden X .0004 x $258/hr. In this rulemaking the cost
increased significantly from $5K to $209K, because of an increase
in hourly cost from $205/hr to $258/hr; an increase in
recordkeeping hours; a one-time recordkeeping burden; the capture
of 3rd party recordkeeping hours and the purchase of new equipment.
The regular recordkeeping burden is an estimated 527,046 hours
(412,448 hours regular recordkeeping plus 114,598 one-time only
hours) and has an estimated additional cost of $54,391. In
addition, 20 FFD programs are expected to purchase 2 evidentiary
breath testing devices (EBT) each at an estimated additional cost
of $120,000 (20 programs x 2 EBTs x $3,000 per device), of which
this cost will be added to the recordkeeping cost resulting in a
total additional cost of $174,391. The 3rd party recordkeeping
hours are estimated to be 337,162 hours, which results in an
estimated additional cost of $34,795. Thus, the overall total
additional cost for this rulemaking is $209,186 ($54,391 + $120,000
+ $34,795).
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
10CFR26FinalRuleRegAnalApp3.wpd
10CFR26FinalRuleRegAnalApp2.pdf
10 CFR 26, Fitness for Duty Program