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
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Section ID: RG-1.234
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Content:
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 (i.e., vendors or suppliers). Consequently, developing programs that implement the requirements of the regulation poses different challenges for the licensees and vendors. DG-1416, Page 4 In addition, the statements of consideration that accompanied the final rule for 10 CFR Part 52 clarified the applicability of various requirements to each of its licensing processes, including how Section 206 reporting requirements and, therefore, the provisions of 10 CFR Part 21, should be extended to early site permits, standard design certifications, and combined licenses (COLs). Finally, Regulatory Issue Summary (RIS) 2010-05, “Applicability of 10 CFR Part 21 Requirements to Applicants for Standard Design Certifications,” dated May 24, 2010 (Ref. 8), clarified the NRC’s regulatory position regarding the applicability of 10 CFR Part 21 requirements to standard design certification or design certification rule (DCR) applicants (hereafter referred to as DCR applicants) before and after the NRC issues the DCR. Subsequently, NEI 14-09, Revision 1, incorporated all the information provided in RIS 2010-05. Consideration of International Standards The International Atomic Energy Agency (IAEA) and Nuclear Energy Agency (NEA) work cooperatively with member states and other partners to promote the safe, secure, and peaceful use of nuclear technologies. This system of safety fundamentals, safety requirements, safety guides, and other relevant reports, reflect an international perspective on what constitutes a high level of safety. To inform its development of this RG, the NRC considered IAEA and NEA safety requirements and safety guides pursuant to the Commission’s International Policy Statement (Ref. 9) and Management Directive and Handbook 6.6, “Regulatory Guides” (Ref. 10).