Document: NRC Regulatory Guide
Document ID: 244ba017-304c-4f86-818e-a1339242d8c1
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:
h Street, NW, Washington, DC, 20503; email: oira_submissions@omb.eop.gov. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number. DG-1416, Page 3 B. DISCUSSION Reason for Issuance Revision 0 of this guide was issued to provide licensees and applicants with an acceptable method of evaluating and reporting defects in compliance with 10 CFR Part 21. Specifically, this guide endorses Nuclear Energy Institute (NEI) 14-09, “Guidelines for Implementations of 10 CFR Part 21 Reporting of Defects and Noncompliance,” Revision 1, issued February 2016 (Ref. 7), which was developed to incorporate previous guidance in NUREG-0302; to add additional clarity in the specific areas where issues have historically occurred; and to include experience gained from the nearly 40 years of complying with 10 CFR Part 21. This revision of this guide (Revision 1) clarifies the NRC’s definition of counterfeit, fraudulent, and suspect items (CFSI). In addition, the staff made several editorial changes to conform to the current format and content of RGs. Background The regulations in 10 CFR Part 21 establish the requirements for procedures to evaluate and report in order to implement the requirements of Section 206 of the Energy Reorganization Act of 1974, which requires that the NRC receive immediate notification that a facility, activity, or basic component (1) fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable NRC rule, regulation, order, or license of the Commission relating to substantial safety hazards or (2) contains a defect that could create a “substantial safety hazard,” 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