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
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CFR Title: 

Content:
of the Code of Federal Regulations (10 CFR) Part 21, “Reporting of Defects and Noncompliance” (Ref. 1). Applicability This RG applies only to applicants, licensees, dedicating entities, and their suppliers associated with constructing, owning, operating, or supplying nuclear power plants subject to 10 CFR Part 21, and regulated pursuant to 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities” (Ref. 2), and 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants” (Ref. 3). Applicable Regulations • 10 CFR Part 21 establishes the requirements for procedures to evaluate and report in order to implement the requirements of Section 206, “Noncompliance,” of the Energy Reorganization Act of 1974 (Ref. 4), 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 (Ref. 5), 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. • 10 CFR 50.55(e) requires, among other things, procedures that evaluate deviations and failures to comply associated with substantial safety hazards as soon as practicable, and in all cases within 60 days of discovery for holders of facility construction permits under 10 CFR Part 50; and, for holders of combined licenses (until the Commission makes the finding under 10 CFR 52.103(g)) and manufacturing licenses under 10 CFR Part 52. This requirement overlaps and supports the 10 CFR Part 21 requirements because both 10 CFR Part 21 and 10 CFR 50.55(e) require that deviations and failures be evaluated. DG-1416, Page 2 Related Guidance • NUREG-0302, Revision 1, “Remarks Presented (Questions/Answers Discussed) at Public Regional Meetings to Discuss Regulations (10 CFR Part 21) for Reporting of Defects and