As anticipated in our September 3 blog, the NRC on September 16 published in the Federal Register a proposed rule and request for comment regarding its amendment of 10 CFR Part 26, “Fitness for Duty Programs” (FFD). We reported on the Commission’s approval of the rulemaking and the NRC Staff’s Draft Regulatory Analysis and Backfitting and Issue Finality.
In recap, the purpose of this rulemaking is to align more closely the NRC’s drug testing program with the US Department of Health and Human Services’ (HHS’s) 2008 “Mandatory Guidelines for Federal Workplace Drug Testing” (the 2008 Guidelines). The major provisions of this proposed rule would
- add initial and confirmatory drug testing for two illegal Ecstasy-type drugs;
- add initial drug testing for 6-acetylmorphine (6-AM) a metabolite of heroin, and update the confirmatory testing method for 6-AM;
- lower the drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine;
- enhance the detection of subversion attempts by strengthening the testing methods used to identify drug metabolites in urine specimens; and
- require medical review officers to evaluate the elapsed time from specimen collection to testing and exposure to high temperatures as possible causes of some invalid test results.
The NRC Staff also released an updated Draft Regulatory Analysis and Backfitting and Issue Finality as part of this rulemaking. The Staff made very few changes to the regulatory analysis discussed in our earlier post, and made no changes to their cost-benefit and backfit and issue finality analyses. Thus, NRC Staff still concludes that the proposed rule would substantially increase public health and safety because of the estimated 10-12% increase in positive test results, and this benefit outweighs the low cost of implementing this rule (estimated at $2.2 million over 25 years using a 7% discount rate). The Commission is seeking comment on the cost-benefit estimates in the draft regulatory analysis.
Besides seeking comment on the cost-benefit estimates, the Commission is requesting comment on four questions to better understand the cumulative effects of regulation (CER) that licensees or other impacted entities may face while implementing new regulatory programs (see Section IX of the Federal Register Notice) (paraphrased below):
- Does the proposed effective date (60-days after publication of the final rule) provide sufficient time to implement the new proposed requirements, including changes to programs, procedures, and the facility?
- If CER challenges exist, what should be done to address them?
- Do other regulatory actions (from NRC or other agencies) influence the implementation of the proposed rule’s requirements?
- Does the proposed rule create unintended consequences and create conditions contrary to its purpose and objectives? If so, what are these unintended consequences, and how should they be addressed?
Comments on the proposed rule and the draft regulatory analysis are due by December 2, 2019.