Guidance on Implementation of 10 CFR Part 21 Requirements

The U.S. Nuclear Regulatory Commission (NRC) staff has developed several regulatory guides endorsing industry guidance documents as an acceptable method for: (1) evaluating and reporting defects in compliance with the requirements of Title 10 of the Code of Federal Regulation (10 CFR ) Part 21, "Reporting of Defects and Noncompliance," and (2) dedicating commercial-grade items and services, and commercial-grade design and analysis computer programs as basic components for use in safety-related applications in compliance with the requirements of 10 CFR Part 21 and Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities."

1. Regulatory Guide (RG) 1.234, "Evaluating Deviations and Reporting Defects and Noncompliance." This RG provides licensees, applicants and their suppliers with an acceptable method of evaluating and reporting defects under 10 CFR Part 21. This RG endorses, with clarifications, the Nuclear Energy Institute (NEI) 14-09, Revision 1, "Guidelines for Implementation of 10 CFR Part 21, Reporting of Defects and Noncompliance," Revision 1, dated February 2016.

2. NEI 14-09, Revision 1: NEI 14-09, Revision 1, describes an acceptable method that nuclear power licensees and their suppliers of basic components can comply with the evaluation and reporting requirements of 10 CFR Part 21. It is was developed to incorporate previous guidance in 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 Noncompliance;" to add clarity in the specific areas where issues have historically occurred; and to include experience gained from the nearly 40 years of compliance with 10 CFR Part 21. For example, NEI 14-09, Revision 1, captures the NRC staff's positions on the following subjects: (1) interfaces with other regulations such as 10 CFR 50.55e (Section 5); (2) maintaining records of 10 CFR Part 21 evaluations that do not result in a notification to the NRC (Section 6.2); (3) information related to location and types of postings (e.g., electronic and document posting) (Section 6.3); (4) the significance of specifying 10 CFR Part 21 requirements in procurement documents (Section 6.5); (5) clarification on the point of discovery and the discovery process (Sections 2.8 and 7.2); (6) notification process when a deviation is identified in a delivered basic component (Sections 7.4 and 7.5); (7) communication between purchasers and suppliers during the evaluation and notification process (Section 8.2); and (8) transfer of evaluation and reporting responsibilities (Section 8.3). Furthermore, to aid in the understanding of the evaluation and notification process, NEI 14-09, Revision 1, includes a process flowchart in Appendix A, as well as an example of a discovery and evaluation checklist template in Appendix B. This guidance document has not been evaluated for facilities, activities and basic components regulated by the NRC pursuant to other parts of Title 10 of the CFR (e.g., 10 CFR Part 30, 31, 33, 34, 35, 36, 39, 40, 60, 61, 63, 70, 71, 72, and 76).

3. RG 1.164, "Dedication of Commercial-Grade Items for Use in Nuclear Power Plants." This RG provides licensees, applicants and their suppliers of basic components guidance for dedication of commercial-grade items and services to be used as a basic component for nuclear power plants. This RG endorses, in part, with certain clarifications and exceptions, the Electric Power Research Institute (EPRI) 3002002982, "Revision 1 to EPRI NP-5652 and TR-102260, Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items In Nuclear Safety-Related Applications, with respect to acceptance of commercial-grade dedication of items and services to be used as basic components in nuclear power plants.

4. EPRI 3002002982: The EPRI 3002002982 report reflects lessons learned and addresses challenges that have been identified through expanded use of the original guidance for commercial-grade dedication. This report includes important updates to the commercial-grade dedication methodology that reflect key clarifications and enhancements between the original guideline and this the new EPRI guidance. For example, it includes (1) a discussion related to the paths that a supplier can follow to provide a basic component; (2) clarification that a completed and accepted design is required prior to beginning the commercial-grade dedication process; (3) clarification that a failure modes and effects analysis is an effective tool to determine critical characteristics when complete design information is not available; and (4) clarification that product identification attributes are not necessarily critical characteristics as defined in 10 CFR Part 21.

5. RG 1.231 , "Acceptance of Commercial-Grade Design Analysis Computer Programs Used in Safety-Related Applications for Nuclear Power Plants." This RG provides guidance for the commercial-grade dedication of design and analysis computer software programs that are used as basic components in safety-related applications. This RG endorses with clarifications, EPRI Technical Report (TR)-1025243, "Plant Engineering: Guideline for the Acceptance of Commercial-Grade Design and Analysis Computer Programs Used in Nuclear Safety-Related Applications," Revision 1, as an acceptable method for demonstrating compliance with the requirements of 10 CFR Part 21 and Appendix B to 10 CFR Part 50, for the commercial-grade dedication of design and analysis computer software programs as basic components for use in safety-related applications. This RG does not apply to the acceptance of commercial-grade computer programs at nuclear power plants which are not for design and analysis (e.g. programs which perform instrumentation and control functions).

6. Revision 1 of EPRI TR-1025243: TR-1025243, Revision 1, provides guidance on activities associated with assuring quality in commercial-grade design and analysiscomputer software programs that are to be used as basic components in safety-related applications. It incorporates knowledge of industry standards and operational experience in the formulation of quality assurance guidance supporting both operating nuclear plant operations and upgrades, and new nuclear plant design and construction. The TR also provides a generic process for dedicating commercially procured computer software programs that is consistent with the regulations.