Document: NRC Regulatory Guide
Document ID: 03c00005-0de2-4b04-8d8a-68c1e7b6a242
Document Type: regulatory_guide
Title: Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21 + HISTORY - HISTORY 11/2023 – DG-1416 , Proposed Revision 1 07/2017 – DG-1291 , Proposed Revision 0 (Rev. 1)
Source: NRC Regulatory Guide Division 1
Source URL: https://www.nrc.gov/docs/ML2318/ML23187A549.pdf
Revision Date: 2023-11
Chapter: 
Section ID: RG-1.234
CFR Part: 
CFR Title: 

Content:
zard,” as defined by NRC regulations. The purpose of the evaluation and reporting requirements in 10 CFR Part 21 is to enhance the NRC’s “defense in depth” measures for assuring the public’s health and safety. Reporting of defects and non-compliances that could create a substantial safety hazard ensures that the NRC receives prompt notification of such instances. NRC findings related to failures to report in accordance with 10 CFR Part 21 are important. The NRC considers non-compliances to be safety and security indicators potentially affecting the agency’s ability to carry out its statutory mission. Many of the surveillance, quality control, and auditing activities that both the NRC and its licensees rely on to monitor compliance with safety standards are based primarily on complete, accurate, and timely recordkeeping and reporting. Therefore, the NRC may consider a failure to make a required report that impedes its ability to take regulatory action to be significant, even if that failure was inadvertent or did not result in an actual consequence. Since it was codified in 1977, 10 CFR Part 21 has presented compliance challenges to licensees and vendors. Furthermore, attempts to provide guidance for evaluating and reporting under 10 CFR Part 21 for power reactor licensees and vendors (e.g., presentations and questions and answers issued in conjunction with vendor workshops, generic communications) have been unable to reduce the incidence of NRC inspection findings associated with inadequate implementation of 10 CFR Part 21. Since the issuance of RG 1.234, Revision 0, the number of NRC inspection findings have been reduced when the guidance in RG 1.234 was implemented correctly. The applicability of 10 CFR Part 21 is broader than most NRC regulations. Its requirements impose obligations on certain officers of NRC licensees and on certain officers of non-licensees that construct facilities for, or supply components to, licensed facilities or activities