The Nuclear Regulatory Commission (NRC) hosted a public meeting on April 13 to discuss and solicit stakeholder feedback on the cumulative effects of regulation regarding final changes made to the fitness-for-duty (FFD) drug testing requirements in 10 CFR Part 26 (Part 26). The NRC published the proposed rule in the Federal Register on September 16, 2019, to align Part 26 with certain drug testing provisions in the 2008 Health and Human Services Guidelines.
The Staff received 22 comments by the close of the public comment period on December 2, 2019. The Staff does not expect its proposed 60-day implementation schedule to have a significant impact on affected licensees and other entities and intends to submit the final rule to the Commission for approval by September 15, 2021. Read the Staff’s presentation from the meeting.
A summary of the public meeting and changes to Part 26 appear below.
Rule Changes
The rule incorporates the following changes to the NRC’s FFD drug testing requirements in Part 26:
- Drug Testing Panel
The rule makes several changes to the drug testing panel included in Part 26. These changes include lowering testing cutoff levels for amphetamine, methamphetamine, and cocaine metabolite; adding methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA) to the testing panel; and revising the testing approach for 6-acetyl morphine (6-AM).
- Subversion Attempt Detection
The rule incorporates measures to detect and prevent attempts to circumvent testing. For example, the rule revises the special analyses testing provisions in Section 26.163(a)(2) by requiring special analyses testing when a specimen with a dilute validity test result has a drug or drug metabolite concentration at least 40% of the initial test cutoff. It also changes the confirmatory test cutoff from the Limit of Detection to the Limit of Quantitative.
Additionally, the rule requires special analyses testing when (1) a donor provides a urine specimen with a substituted, adulterated, or invalid test result with no adequate medical explanation; (2) a donor’s specimen is outside the acceptable temperature range (90-100° F); (3) a donor’s conduct indicates a possible subversion attempt; and (4) a specimen is unavailable for retesting.
- Shy-Bladder Process
The rule permits a member of the FFD program – or other personnel, unrelated to the FFD program – to observe a donor during the hydration process. This requirement differs from the proposed rule, which required the hydration monitor to be a member of the FFD program.
- Other Changes
The Staff also incorporated several substantive changes to the final rule as a result of public comment, including expanding the drug testing panel to include hydrocodone, hydromorphone, oxycodone, and oxymorphone, and to provide the option to collect an oral fluid specimen for direct observation conditions.
Comments and Next Steps
Only one meeting participant, a representative from the Nuclear Energy Institute, commented at the meeting. He expressed concern that the 60-day implementation period is too short and suggested a one-year implementation period would be more appropriate to allow for change management and to update information technology and NANTEL systems. The Staff said it would take that concern under advisement.
Updates to the rulemaking process are located at www.regulations.gov under Docket ID NRC-2009-0225. Morgan Lewis will continue to monitor the rulemaking process and report on any additional changes.