ML22153A416
| ML22153A416 | |
| Person / Time | |
|---|---|
| Issue date: | 10/25/2022 |
| From: | Dinesh Taneja NRC/NRR/DEX |
| To: | |
| Eudy M | |
| Shared Package | |
| ML21355A004 | List: |
| References | |
| DG-1402 RG 1.250 Rev 0 | |
| Download: ML22153A416 (5) | |
Text
Response to Public Comments on Draft Regulatory Guide (DG)-1402 Dedication of Commerical-Grade Digital Instrumentation and Control Items for Use in Nuclear Power Plants Proposed New Regulatory Guide (RG) 1.250 On March 18th, 2022, the U.S Nuclear Regulatory Commission (NRC) published a notice in the Federal Register (87 FR 15456) that Draft Regulatory Guide, DG-1402, (Proposed New Regulatory Guide (RG) 1.250), was available for public comment. The Public Comment period ended on April 18th, 2022. The NRC received comments from the organization listed below. The NRC has combined the comments and NRC staff responses in the following table.
Alan Campbell, Technical Advisor Generation and Suppliers Nuclear Energy Institute (NEI) 1201 F. Street, NW, Suite 1100 Washington, DC 20004 ADAMS Accession No. ML22112A074
Commenter Section of DG-1388 Specific Comments NRC Resolution (These are the full comments as provided in each submission)
Alan Section C, Staff Comment 1: The NRC generally agrees with the Campbell, Regulatory This section requires each dedicating entity to perform a comment but normal Appendix B NEI Guidance Section unique dedication of certifying body's services. The intent of procurement processes should be used in 1.b NEI 17-06, Rev. 1 is to allow for the certification bodies acquiring information to be used in the dedications, performed in accordance with NEI 17-06 Rev. 1 dedication of certifying bodies. The NRC Section 5.3, to be utilized by other licensees, designees, or will add the following text to clarify Staff dedicating entities. As noted in DG-1402, NEI 17-06 position 1.b:
demonstrates the dependability critical characteristics described in EPRI TR-106439 can be met if equipment is Accreditation activity observations manufactured to an appropriate safety integrity level (SIL) in performed in accordance with NEI 17-06 conformance with IEC 61508. The dedication process Section 5.3 may be performed by a U.S.
described within NEI 17-06 verifies the Accreditation Body NRC licensee, their designee, or the and Certification Body knowledge, skills, and adherence to dedicating entity. If more than one licensee standards. This process does not vary based on the project or or dedicating entity intends to use SIL technology being procured, allowing for transference of the certification from a single certifying body, a dedication results with no impact to their acceptability. licensee or dedicating entity may either Limiting the acceptability of each dedication activity to only perform commercial grade dedication of the the dedicating entity that performed the dedication process certifying body or arrange for commercial limits the use of this guidance and imposes undue burden on grade dedication of the certifying body on implementors, Accreditation Bodies and Certification Bodies behalf of itself and other licensees or by increasing the demand to perform observations of the dedicating entities to reduce the number of accreditation process. commercial grade dedications of the certifying body. The scope of this Recommendation: commercial grade dedication should satisfy NEI 17-06 states, among other things, that the certifying the needs of all the purchasers, and all the bodys services should be dedicated by [a] U.S. NRC purchasers for whom the commercial grade licensee, their designee, or the dedicating entity. To be clear, dedication was conducted should receive the each dedicating entity should dedicate the services of each relevant records. Nevertheless, each of the certifying body whose certificates the dedicating entity wishes licensees or dedicating entities relying on to rely on, and should not rely on dedication by, e.g., another the results of a commercial grade dedication NRC licensee. Accreditation activity observations performed on behalf of licensees or performed in accordance with NEI 17-06 Section 5.3 may dedicating entities remains individually 2
Commenter Section of DG-1388 Specific Comments NRC Resolution (These are the full comments as provided in each submission) be performed by a U.S. NRC licensee, their designee, or responsible for the adequacy of the the dedicating entity and, once accepted, used as input to commercial grade dedication.
other licensees, designees, or dedicating entities in support of their own commercial grade dedication process. The changes identified above were made to DG-1402 as a result of this comment.
Alan Section B. Comment 2: NRC partially agrees with the comment.
Campbell, Discussion for "NEI 17-06 leverages the internationally recognized safety NEI 17-06, in addition to criteria in IEC NEI Issuance integrity level (SIL) certification process in International 61508, relies on a certification process, Electrotechnical Commission (IEC) 61508, "Functional Safety therefore the NRC revised Section B of DG-of Electrical/Electronic/Programmable Electronic Safety- 1402 as follows:
related Systems," Edition 2.0, issued April 2010 (Ref. 8)." The certification process is not described in IEC 61508. The NEI 17-06 leverages an internationally certification process is based on the criteria in IEC 61508. recognized safety integrity level (SIL) certification process that relies on Recommendation: International Electrotechnical Commission NEI 17-06 leverages internationally recognized safety (IEC) 61508, integrity level (SIL) criteria in International Electrotechnical Commission (IEC) 61508, "Functional Safety of The changes identified above were made to Electrical/Electronic/Programmable Electronic Safety-related DG-1402 as a result of this comment.
Systems," Edition 2.0, issued April 2010 (Ref. 8)."
Alan Section B. Comment 3: NRC agrees with the comment. The Campbell, Discussion In the statement beginning with "Verification of acceptability recommended edit clarifies that the NRCs NEI Background of the certifying bodys commercial grade surveys," the purpose for DG-1402 was the suitability of certifying body does not have or perform a survey. The 17-06 to meet Part 21 requirements for the certifying body performs a commercial grade service. dedication process.
Recommendation: The recommended edit has been Include text consistent with Public Meeting slide 7, 1st bullet incorporated into DG-1402 as a result of point to define equivalent terms prior to this statement to this comment.
provide appropriate context. "The NRC staff considers SIL certification to be a commercial grade survey for the purposes of Part 21."
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Commenter Section of DG-1388 Specific Comments NRC Resolution (These are the full comments as provided in each submission)
Alan Section C. Staff Comment 4: NRC agrees with the comment, but not the Campbell, Regulatory References to IEC 61508 in the 2nd and 3rd sentences should recommended edit entirely. NRC staff made NEI Guidance Section be replaced with references to NEI 17-06. IEC 61508 does not the following edits to clearly indicate that 2.a address requirements for certifying bodies. NEI 17-06 is leveraging an existing process as follows:
Recommendation:
The NRC staff is aware that unaccredited certifying bodies The NRC staff is aware that unaccredited exist that claim to provide SIL certification under IEC 61508. certifying bodies exist that claim to provide However, NEI 17-06 stipulates that certifying bodies be SIL certification under IEC 61508.
accredited by signatories to the International Accreditation However, NEI 17-06 reiterates that Forum Multilateral Recognition Arrangement. The NRC staff certifying bodies be accredited by has not reviewed and is not endorsing the use of SIL signatories to the International certification by certifying bodies that have not been accredited Accreditation Forum Multilateral in conformance with NEI 17-06. Therefore, dedicating entities Recognition Arrangement. The NRC staff should verify the certifying bodys accreditation consistent has not reviewed and is not endorsing the with the guidance in section 6.3 of NEI 17-06. use of SIL certification by certifying bodies that have not been accredited in conformance with the mutual recognition arrangement as described in NEI 17-06.
The changes identified above were made to DG-1402 as a result of this comment.
Alan Section C. Staff Comment 5: NRC disagrees with the recommendation.
Campbell, Regulatory Section 7.3 of NEI 17-06 states, [t]he U.S. nuclear industry This issue is beyond the scope of DG-1402 NEI Guidance Section observations will be performed initially on a three (3) year as discussed below:
1.c frequency with the possibility of re-evaluating the frequency based on the results of the observations. To be consistent with RG 1.28, revision 5, endorses various NRC staff-accepted practices, the certifying bodies IEC versions of ASME NQA-1 standard, with 61508 SIL certification process should be observed every 3 2015 being the most recent version years. endorsed. Part I, Requirement 18, Section 202 (external audits), of the 2015 NQA-1 Recommendation: version states that External audits (e.g.,
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Commenter Section of DG-1388 Specific Comments NRC Resolution (These are the full comments as provided in each submission)
NRC should allow for re-evaluation of the frequency based on Supplier audits) shall be performed on a actual results from the initial observations and not rely on triennial basis and supplemented by annual current practices. evaluations of the Suppliers performance to determine if the regular schedule audit frequency shall be maintained or decreased or if other corrective action is required. A continuous or ongoing evaluation of the Suppliers performance may be conducted in lieu of the annual evaluations, provided that the results are reviewed in order to determine if corrective action is required.
This position reflects industry standard practice and the position the NRC staff has long taken on this topic.
Therefore, no changes were made to DG-1402 as a result of this comment.
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