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

The NRC will soon issue in the Federal Register a proposed rulemaking to amend the drug testing requirements of the Fitness for Duty (FFD) Program in 10 CFR Part 26. The proposed rule seeks to align the NRC’s drug testing requirements in Part 26 with the US Department of Health and Human Services’ (HHS’s) 2008 Mandatory Guidelines for Federal Workplace Drug Testing Programs (the 2008 Guidelines). The NRC is expected to publish the proposed rule in the coming weeks, but the draft rule with comments from the Commission is available, as well as the NRC Staff’s Draft Regulatory Analysis and Backfitting and Issue Finality.

The NRC last updated its drug testing requirements in March 2008, but HHS did not issue the 2008 Guidelines until November 2008. The NRC Staff decided to forgo another round of rulemaking to align Part 26 with the 2008 Guidelines in such close succession. Instead, the NRC Staff worked with the industry to institute a voluntary reporting system for FFD testing violations. The NRC Staff also began evaluating the effectiveness of the drug testing program changes implemented under the 2008 Guidelines. In February 2017, the NRC Staff sought Commission approval to publish a proposed rule to align the NRC’s FFD drug testing program with the 2008 Guidelines. The Commission approved this request in May 2019, subject to certain changes to the draft rule.

In the latest installment of NRC’s changes to its guidance on backfitting on May 29, the Commission approved the Staff’s proposed revisions to Management Directive (MD) 8.4, previously titled, “Management of Backfitting, Issue Finality, and Information Collection” and its companion Directive Handbook (DH). As a result of content changes (discussed herein), the title of these directives has now been modified to also provide guidance for the “forward-fitting” requirements for 10 CFR Part 52 licensees by including its analogous terms for Backfitting, “forward fitting and issue finality.” As such, NRC guidance on Backfitting is now called “Management of Backfitting, Forward Fitting, issue Finality, and Information Requests.”

A divided Commission at the US Nuclear Regulatory Commission (NRC) on January 24 approved the Mitigation of Beyond-Design-Basis Events rulemaking (Final Rule). The NRC began the rulemaking in December 2016 as part of its efforts to evaluate and implement, if necessary, regulatory changes in response to the Fukushima Daichi event in March 2011. In somewhat of a surprise, the majority of Commissioners last week rejected large portions of the proposed rule submitted by the NRC staff over two years ago. The rationale for changing the Final Rule demonstrates a renewed emphasis on applying backfit analyses.

The nuclear industry periodically has urged the US Nuclear Regulatory Commission (NRC) to more diligently apply the backfit rule when NRC staff attempts to change its position without proper justification.1

These industry requests apparently were heard by the NRC, as evidenced by an NRC letter dated July 19, 2017 (and made public on July 27, 2017) that addresses the NRC’s review of its application of the 10 CFR 50.109 backfit process. The letter also contains the NRC Executive Director for Operations (EDO) Victor McCree’s response to the report and recommendations of the Committee to Review Generic Requirements (CRGR), which issued its report on June 27, 2017 in response to a request by the EDO on June 9, 2016. (For more info on the NRC’s backfit compliance reviews, see our previous posts on the subject.)

On December 20, the NRC’s Office of the General Counsel (OGC) issued a memorandum to the Committee to Review Generic Requirements (CRGR) summarizing key policy recommendations contained in COMSECY-16-0020 (“Recommendation on Revision of Guidance Concerning Consideration of Cost and Applicability of Compliance Exception to Backfit Rule”).

The OGC’s summary is one of several actions taken by the NRC linked to a licensee’s successful challenge this past summer (with support from the Nuclear Energy Institute (NEI)) to an NRC-proposed backfit, which invoked the “compliance exception” to the Backfit Rule.

In a September 15, 2016, letter to Exelon, the Nuclear Regulatory Commission’s (NRC’s) executive director for operations (EDO) granted Exelon’s appeal of the NRC’s attempted imposition of a backfit by using the compliance exception to the backfit rule. Using that exception would have allowed the NRC to impose the backfit without justifying its actions from a cost-benefit perspective.

Although this event has been much reported by the various nuclear-related publications, we point you to something contained within the EDO issuance that may have gone unnoticed by those who do not routinely face backfit situations (or choose to not pursue this area of regulatory challenge). In a September 15, 2016, memorandum to William Dean, the director of the Office of Nuclear Reactor Regulation, the EDO repeated numerous times that he recognized the associated technical issues, but in the end, focused on whether the threshold for meeting the compliance backfit exception was met. The threshold involved whether the NRC Staff’s position addressed a failure to meet known and established commission standards because of an omission or a mistake of fact. New or modified interpretations of what constitutes compliance therefore do not fall within the compliance exception.