ML21223A311

June 23, 2021, Summary of NEI-17-06 Endorsement Review Public Meeting Held on

ML21223A311
Person / Time
Issue date:	08/16/2021
From:	Serita Sanders Licensing Processes Branch
To:	Dennis Morey Licensing Processes Branch
Saunders S
Shared Package
ML21218A090	List: ML21223A311
References
NEI-17-06
Download: ML21223A311 (6)

Text

August 16, 2021 MEMORANDUM TO: Dennis Morey, Chief Licensing Projects Branch Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation FROM:

Serita Sanders, Project Manager /RA/

Licensing Projects Branch Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation

SUMMARY

OF NEI-17-06 ENDORSEMENT REVIEW PUBLIC MEETING HELD ON JUNE 23, 2021 On June 23, 2021, the U.S. Nuclear Regulatory Commission (NRC) met with the Nuclear Energy Institute (NEI) in a virtual public meeting to present preliminary comments made by the staff during the endorsement review of NEI 17-06, Rev. 0, Guidance on Using IEC 61508 SIL Certification to Support the Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Related Applications (Agencywide Documents Access and Management (ADAMS)

Accession No. ML21083A147). The NRC staff presentation can be viewed at ADAMS Accession No. ML21173A336. Enclosed is the meeting attendee list.

The following two action items were identified during the meeting regarding the NRC review toward endorsing NEI 17-06, Rev. 0:

NEI to provide written responses to the staffs exida, LLC audit observations discussed during this meeting. On November 3-6, 2020, the NRC staff observed an accreditation evaluation (audit) of exida, LLC performed by the American National Standards Institute National Accreditation Board (ANAB) to facilitate the NRC staffs review of the NEI 17-06 guideline. The NRC staff made five observations during this ANABs audit of exida, LLC, which were subsequently communicated to NEI. During this meeting, these five observations were discussed and NEI provided feedback on each, as described below.

NEI committed to getting back to NRC with confirmation of the NEI deliverable dates (below in bold text) in the NEI 17-06 milestone schedule shared during the meeting.

Enclosure:

As stated CONTACT:

Serita Sanders, NRC/DORL/LLPB 301 415-2956

Discussion of staffs observations made during the Nov-2020 ANABs audit of exida, LLC Staffs Observation No. 1: NEI to review the Electric Power Research Institute (EPRI) information used to support the use of the IEC 61508 technical standard to determine if the NEI checklist could be satisfactorily completed using the information for the three certifying bodies (CBs) discussed in the EPRI report (TÜV-Nord, TÜV-Sud, and exida, LLC). If anything would need to be supplemented, NEI would re-engage with ANAB and exida, LLC to resolve.

NEI FEEDBACK PROVIDED DURING THE MEETING: NEI reviewed EPRI information and attempted to complete the NEI supplemental CB audit checklist with it. However, NEI was unable to use only the EPRI information to meet the checklist requirements. Subsequently, NEI engaged exida, LLC directly, worked through information, and determined that the additional information could be used to meet the checklist requirements. The completed supplemental checklist for exida, LLC is in Appendix E of NEI 17-06. Thus far, NEI has not had similar interactions for other CBs, such as TÜV-Nord and TÜV-Sud. For this reason, the NEI supplemental checklist would have to completed for other CBs when any digital item being dedicated has been SIL certified by these CBs.

Staffs Observation No. 2: NEI would evaluate and revise the checklist to better align with the ANAB process and discuss with ANAB opportunities to incorporate this information or supplement the ANAB accreditation process checklist as a routine activity for IEC 61508 scheme CBs accreditation.

NEI FEEDBACK PROVIDED DURING THE MEETING: NEI revised the checklist used during the audit to supplement ANABs audit checklist. This updated checklist is Appendix D of NEI 17-06, which is a higher-level document and now more appropriate for audit activities.

Based on NEIs engagement with ANAB, the current approach in NEI 17-06 (in Chapter 5, paragraph 5.5) includes wording to allow incorporation of NEIs revised checklist to be used to enhance ANABs process. NEIs expectation is that ANAB would establish processes to add rigor that will ensure a CB has a scheme that complies with IEC-61508, rather than to dictate use of the NEI checklist. ANAB is in agreement with NEI on this approach. As a result, ANAB is working on corrective actions.

Additionally, NEI is planning to observe ANABs next exida, LLC audit later in the calendar year.

The initial NEI expectation regarding the revised checklist was that industry could apply the revised checklist (rather than ANAB), due to the additional time and effort it would take for ANAB to utilize the revised checklist. When the ANAB audit checklist adequately includes the supplemental information contained in the NEI revised checklist, NEI will then revise the NEI 17-06 guidance document based on the results of the ANAB accreditation activity.

Staffs Observation No. 3: NEI will develop a process to have designated representatives of the industry perform the NEI checklist on CBs that have not been previously evaluated by EPRI. This process would eventually be taken over by ANAB adopting the checklist into its process but would need to be performed by designated industry representatives until ANAB completes adoption (as well as other accreditation bodies under the International Agreement Forum agreement).

NEI FEEDBACK PROVIDED DURING THE MEETING: NEI does not make commitments for other organizations. While adherence to the NEI revised checklist has not been finalized, NEI anticipates that Industry will determine the manner of implementation. NEI stated that as a

start, individual licensees could utilize its revised checklist as deemed appropriate. Currently, the NEI 17-06 guidance document, Appendix E, is exida, LLC-specific. If exida, LLC is the CB, then a licensee can utilize this checklist. Moreover, the checklist usage with exida, LLC does not require any supplemental activity.

If a licensee wants to use a product certified by a CB other than exida, LLC, they now have options. For example, they could engage the CB to complete the checklist. Alternatively, a licensee could enlist an industry-wide organization, such as Nuclear Procurement Issues Corporation or Institute of Nuclear Power Operations. These details will be revealed after industry begins to utilize the guidance.

NEI indicated that training and guidance for industry on how it should use NEI 17-06 is planned.

This training would be the licensee or organization that represents the licensee.

Staffs Observation No. 4: NEI will discuss with ANAB future oversight activities and also gain better understanding of ANAB auditor qualification process to help assure capability of performing NEI Checklist evaluation.

NEI FEEDBACK PROVIDED DURING THE MEETING: NEIs expectation is to gain alignment on key IEC 61508 requirements to be checked. NEI has asked ANAB to put changes in place that will evaluate the CB scheme as being compliant with IEC 61508. NEI has provided ANAB with the NEI checklist to use as reference guidance and not verbatim compliance. ANAB has indicated to NEI that it plans to demonstrate an increased level of rigor in evaluating the CBs scheme as being compliant with IEC 61508 by the end of this year. To date, ANAB has not provided NEI feedback with specifics of their corrective actions. NEI interactions with ANAB had been limited (in part due to the pandemic) to one exchange to present what NEI saw as gaps in ANABs approach to evaluate a CBs scheme as being compliant with IEC 61508. NEI has not planned additional interactions with ANAB and will consider it.

NEI acknowledged that the auditor qualification process was discussed with ANAB, and corrective actions were expected in this area.

Staffs Observation No. 5: NEI will update 17-06 to better reflect the methodology used to rely on the CB scheme for performing evaluation of the OEM, including adding the results of the completion of the NEI checklist for the three CBs evaluated in the EPRI report, adding the checklist to the proposed methodology to be used by industry going forward, and more thoroughly explaining the quality assurance activities for the proposed NEI 17-06 methodology.

NEI FEEDBACK PROVIDED DURING THE MEETING: NEI would like to observe ANAB activities in support of NEI 17-06 this year and next year before making any changes to NEI 17-06. NEIs position is there is no need for earlier updates to NEI 17-06 based upon any changes ANAB makes to the level of rigor of its processes.

NEI would like the NRC staff to review NEI 17-06 based on the result of the fall 2020 ANAB audit activity.

At the conclusion of the discussion, in response to an NRC question about the need for a commitment from an NEI 17-06 user, NEI acknowledged that expectations for an industry commitment to either engage the CB or enlist an industry-wide organization is not presently described in NEI 17-06.

Further, the NRC reinforced the point that until there is an industry representative designated with the responsibility as described in NEI 17-06, Rev.0, individual licensees will be responsible for ensuring that the accreditation and certification process has been sufficiently consistent and comprehensive for any commercial-grade certified products they are considering for application/implementation for safety related functions.

NEI 17-06 Milestone Schedule (NEI milestones bolded)

NRC provides final set of comments to NEI 31-August-2021 Public meeting to discuss comments & proposed NEI resolutions Week of 13-Sept NEI submits response to the NRC comments 24-Sept-2021 First draft of draft guide DGxxxx 15-Oct-2021 Public meeting to discuss:

Week of 25-Oct Draft Guide & Regulatory Positions NEI proposed revision to NEI 17-06 Finalize Draft Guide DGxxxx 12-Nov-2021 NEI issues final NEI 17-06, Rev. x 3-Dec-2021 Initiate new Regulatory Guide (RG) issuance process 22-Dec-2021 Issue DGxxxx for public comments May 2022 Publish new RG 1.xxxx, Rev. 0, endorsing NEI 17-06, Rev. x Nov 2022 The next public meeting to discuss the staffs final set of comments on NEI 17-06, Rev. 0, and proposed NEI resolutions to the staffs comments is planned for the week of September 13, 2021.

List of Attendees

SUMMARY

OF NEI-17-06 ENDORSEMENT REVIEW PUBLIC MEETING HELD ON JUNE 23, 2021 NAME ORGANIZATION Eric Benner Nuclear Regulatory Commission (NRC)

Jeanne Johnston NRC Frances Pimentel Nuclear Energy Institute (NEI)

Maria Assard NEI Stephen Geier NEI Tom Basso NEI Warren Odess-Gillett Westinghouse Andy Nack Isotek Systems, LLC Serita Sanders NRC Dinesh Taneja NRC David Rahn NRC Jonathan Ortega-Luciano NRC Greg Galletti NRC Jack Zhao NRC Bernard Dittman NRC Sergiu Basturescu NRC Ismael Garcia NRC Marc Tannenbaum EPRI Steve Dragovich Exelon Mark Coren Duke Energy Ron Jarrett Tennessee Valley Authority - retired Enclosure

SUMMARY

OF NEI-17-06 ACCEPTANCE REVIEW PUBLIC MEETING HELD ON JUNE 23, 2021 DATED: AUGUST 16, 2021 DISTRIBUTION:

PUBLIC RidsACRS_MailCTR Resource RidsNrrDorl Resource RidsNrrDorlLlpb Resource RidsNrrPMSSanders Resource RidsNrrLADHarrison Resource EBenner JJohnston DTaneja DRahn JOrtega-Luciano BDittman GGalletti JZhao SBasturescu IGarcia ADAMS Accession Nos.:

ML21218A090 (Package)

ML21223A311 (Meeting Summary)

ML21083A147 (NEI 17-06 Guidance Document)

ML21173A336 (Staff Presentation)

OFFICE NRR/DORL/LLPB/PM NRR/DORL/LLPB/LA NRR/DORL/LLPB/BC NRR/DORL/LLPB/PM NAME SSanders DHarrison DMorey SSanders DATE 8/09/2021 8/13/2021 8/16/2021 8/16/2021