ML21237A305
| ML21237A305 | |
| Person / Time | |
|---|---|
| Issue date: | 08/30/2021 |
| From: | Eric Benner NRC/NRR/DEX |
| To: | Andy Campbell Nuclear Energy Institute |
| Sanders S, NRR/DORL/LLPB | |
| References | |
| NEI 17-06, Rev 0 | |
| Download: ML21237A305 (15) | |
Text
August 30, 2021
Mr. Alan D. Campbell Technical Advisor Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004
SUBJECT:
NRC STAFF COMMENTS ON NUCLEAR ENERGY INSTITUTE 17-06 REVISION 0, GUIDANCE ON USING IEC 61508 SIL CERTIFICATION TO SUPPORT THE ACCEPTANCE OF COMMERCIAL GRADE DIGITAL EQUIPMENT FOR NUCLEAR SAFETY RELATED APPLICATIONS
Dear Mr. Campbell:
On February 23, 2021, the U.S. Nuclear Regulatory Commission (N RC) received a submittal from the Nuclear Energy Institute (NEI) requesting review and e ndorsement of Revision 0 of NEI 17-06, Guidance on Using IEC 61508 SIL Certification to Su pport the Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Related A pplications (Agencywide Documents Access and Management System (ADAMS) Accession No. ML 21083A147). In this request, NEI stated that NEI 17-06 establishes guidance for an acceptable approach to procure and accept commercial grade digital equipment for nuclear safet y-related applications, when the equipment has an accredited third-party safety integrity level (SIL) certification per International Electrotechnical Commission (IEC) 61508. The staff are current ly engaged in evaluating NEI 17-06 for potential endorsement. If found acceptable, the endo rsement would include the development of a draft regulatory guidance document and other n ecessary steps to develop a final regulatory guide. The staff have generated comments in t he enclosed Open Items table that should be addressed by NEI in order for staff to continue its endorsement review.
For dedication of commercial grade digital equipment, leveragin g the SIL certification process as described in NEI 17-06 in lieu of individual supplier survey s is considered a practical alternative to the commercial grade survey methodology currentl y used by dedicating entities.
However, the process as described in NEI 17-06 is currently inf ormal and not specific enough to adequately define an approach that can be endorsed by the NRC w ithout additional clarifications and exceptions. To have confidence in the accre ditation process, a more formal quality assurance oversight process by a specified owner is nec essary. The proposed inclusion of additional accreditation and certifying bodies that have not been adequately vetted by the NEI and NRC does not appear prudent or defensible; especially, give n the shortcomings observed by the staff and NEI with the American National Standards Insti tute (ANSI) National Accreditation Board (ANAB) exida audit as discussed during the June 23, 2021 public meeting (ADAMS Accession No. ML21223A311). Unlike the agreements in pl ace between the International Laboratory Accreditation Cooperation and NEI as a stakeholder member in the accreditation organization, there is no such formality describe d in NEI 17-06 Revision 0 for the international governing bodies responsible for International St andards Organization 17065 and IEC 61508.
A. Campbell
These and other topics are further discussed in specific commen ts on NEI 17-06, Revision 0 are outlined in the enclosed Open Items table. The comments are binned and ranked according to their possible classification as an exception, clarification or suggestion; and, they broadly span the areas of QA oversight, NEI 17-06 scope, and use of EPRI 300 2011817.
The staff has scheduled a phone call for September 9, 2021, if needed, to allow NEI an opportunity to ask clarifying questions to assist in understand ing NRCs comments. To facilitate the review schedule established to develop a draft regulatory g uide, responses to these comments are expected by September 24, 2021.
The next public meeting to discuss the final set of comments on NEI 17-06, Revision 0, and the proposed NEI resolutions to the staffs comments, is scheduled for September 28, 2021.
If you have any concerns or questions, please contact Ms. Serit a Sanders, Project Manager, at (301) 415-2956, or through e-mail to Serita.Sanders@nrc.gov.
Sincerely,
Eric J. Benner, Director Division of Engineering and External Hazards OfficeofNuclearReactorR egulation
cc: Maria Assard
ML21237A305 (Letter)
ML21223A311 (NEI 17-06 Staff Review June 23, 2021 Public Meetin g Summary)
ML21083A147 (NEI 17-06 Guidance Document)
OFFICE NRR/DORL/LLPB/PM NRR/DORL/LLPB/LA NRR/DEX/EICB/BC NAME SSanders DHarrison (RButler for) MWaters DATE 8/25/2021 8/25/2021 8/26/2021 OFFICE NRR/DRO/IQVB/BC NRR/RES/ICEEB/BC NRR/DORL/LLPB/BC NAME KKavanagh CCook DMorey DATE 8/26/2021 8/26/2021 8/26/2021 OFFICE NRR/DEX/ELTB/BC NRR/DEX/D NAME JJohnston EBenner DATE 8/30/2021 8/30/2021