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 NRCÂs 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 NRCÂs 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