On June 8, 2015, the Commission issued a Staff Requirements Memorandum on Project AIM 2020, directing the NRC Staff to perform a prioritization of all agency work. The NRC Staff developed a process that solicited internal and external stakeholder input on prioritizing and re-baselining the agency’s work. On January 31, 2016, the NRC Staff sent a paper, SECY-16-0009, to the Commission transmitting the results of the re-baselining of agency activities and requesting Commission approval to implement recommendations on work to be shed, de-prioritized, or performed with fewer resources. Significantly, the NRC Staff recommended that the agency discontinue rulemaking efforts related to 10 CFR Part 21, “Reporting of Defects and Noncompliance.” In doing so, the NRC essentially adopted the recommendations of industry, which had long argued that the rulemaking was unnecessary.

In SECY-11-0135 and in response to OIG-11-A08, the NRC identified a need to clarify Part 21 requirements. The NRC subsequently held several public meetings with stakeholders to discuss the path forward. In a June 2014 public meeting, the NRC presented its plans to conduct a rulemaking to clarify Part 21 requirements. In response, the Nuclear Energy Institute (NEI) sent a letter to the NRC expressing concerns with the NRC’s approach to clarifying Part 21. NEI noted that a rulemaking was not necessary to clarify Part 21 and stated that a better approach would be to address those issues through NRC or NRC-endorsed guidance. And, we questioned the NRC’s draft regulatory basis for the Part 21 rulemaking here. After further consideration, the NRC apparently agreed with NEI and others. The NRC Staff noted in Enclosure 1 to SECY-16-0009 that “[a]fter extensive work on this rule, staff has concluded that there is not a basis for revising the rule itself, and that necessary changes can be achieved through clarification of the regulatory guidance for the rule.”

Indeed, efforts related to clarifying Part 21 guidance are already well underway. The NRC has created draft Regulatory Guides DG-1291, “Evaluating Deviations and Reporting Defects and Noncompliance,” and DG-1292, “Dedication of Commercial Grade Items” — both of which would clarify NRC expectations with respect to Part 21. Most recently, on February 2, 2016, NEI submitted NEI 14-09, “Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance, Revision 1.” NEI is seeking NRC endorsement of the guidance, which would reflect NRC and industry consensus on clarifications to Part 21 evaluation and reporting requirements. The industry guidance also reflects lessons learned from nearly 40 years of Part 21 implementation.

The NRC Staff’s proposal to terminate Part 21 rulemaking efforts reflects the realities of the moment. Rulemaking is a rigorous, formal, and ultimately costly way to establish agency expectations. While a necessary tool for agencies, rulemaking can become an inefficient and resource-intensive activity if it tries to address too many discrete circumstances or becomes too prescriptive. Given the availability of the guidance development process to resolve stakeholder concerns with Part 21, the agency ultimately took a pragmatic approach that addresses stakeholder concerns and ensures protection of public health and safety. Let’s call this a success story for the agency and for industry efforts to reduce unnecessary regulatory burden.