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{{#Wiki_filter:Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
{{#Wiki_filter:}}
 
==Title:==
Advisory Committee on Reactor Safeguards Open Session Docket Number:    (n/a)
Location:        teleconference Date:            Wednesday, September 7, 2022 Work Order No.:  NRC-2076                            Pages 1-89 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234-4433
 
1 1
2 3
4                              DISCLAIMER 5
6 7  UNITED STATES NUCLEAR REGULATORY COMMISSIONS 8        ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 9
10 11          The contents of this transcript of the 12 proceeding of the United States Nuclear Regulatory 13 Commission Advisory Committee on Reactor Safeguards, 14 as reported herein, is a record of the discussions 15 recorded at the meeting.
16 17          This transcript has not been reviewed, 18 corrected, and edited, and it may contain 19 inaccuracies.
20 21 22 23 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 1                    UNITED STATES OF AMERICA 2                NUCLEAR REGULATORY COMMISSION 3                                + + + + +
4                            698TH MEETING 5        ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 6                                  (ACRS) 7                                + + + + +
8                                WEDNESDAY 9                        SEPTEMBER 7, 2022 10                                + + + + +
11                  The Advisory Committee met via 12 videoconference at 1:30 p.m., Joy L. Rempe, 13 Chairman, presiding.
14 15 COMMITTEE MEMBERS:
16            JOY L. REMPE, Chairman 17            WALTER L. KIRCHNER, Vice Chairman 18            DAVID A. PETTI, Member-at-Large 19            RONALD G. BALLINGER, Member 20            VICKI M. BIER, Member 21            CHARLES H. BROWN, JR., Member 22            VESNA B. DIMITRIJEVIC, Member 23            GREGORY H. HALNON, Member 24            JOSE A. MARCH-LEUBA, Member 25            MATTHEW W. SUNSERI, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 1 ACRS CONSULTANTS:
2            DENNIS BLEY 3
4 DESIGNATED FEDERAL OFFICIAL:
5            CHRISTINA ANTONESCU 6
7 8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 1                      P R O C E E D I N G S 2                                                          (1:30 p.m.)
3                    CHAIRMAN REMPE:                Okay, folks, its 4 1:30 p.m. on the East Coast.                  So this meeting will 5 now come to order.
6                    This is the first day of the 698th 7 meeting        of  the    Advisory        Committee    on  Reactor 8 Safeguards.          Im Joy Rempe, Chairman of the ACRS.
9  Other members in attendance are Ron Ballinger, 10 Vicki Bier, Charles Brown, Vesna Dimitrijevic, Greg 11 Halnon, Walt Kirchner, Jose March-Leuba, Dave 12 Petti, and Matt Sunseri.                    I note we do have a 13 quorum.        Today, the Committee is meeting in-person 14 and virtual.
15                    The ACRS is established by the Atomic 16 Energy Act and is governed by the Federal Advisory 17 Committee Act.          The ACRS Section of the U.S. NRC 18 public website provides information about the 19 history of this Committee and documents such as 20 our charter, bylaws, Federal Register Notices 21 (audio interference) at least the meetings that 22 are open.
23                    The Committee provides advice on safety 24 matters to the Commission through its publicly 25 available letter reports.
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4 1                  The Federal Register Notice announcing 2 this meeting was published on August 10, 2022.
3 This announcement provided a meeting agenda as well 4 as instructions for interested parties to submit 5 written documents or request opportunities to 6 address the Committee.
7                  The  Designated          Federal      Officer      for 8 todays meeting is Ms. Christina Antonescu.                                A 9 communications channel has been opened to allow 10 members of the public to monitor the open portions 11 of the meeting.
12                  The ACRS is now inviting members of the 13 public to use the MS Teams link to view slides and 14 other        discussion    materials          during    these      open 15 sessions.        The MS Teams link information was placed 16 in the Federal Register Notice and agenda on the 17 ACRS public website.
18                  Periodically, the meeting will be open 19 to accept comments from participants listening to 20 our      meeting.      Written        comments        may  still        be 21 forwarded to the Designated Federal Officer.
22                    During todays meeting, the Committee 23 will consider the following topics: Proposed New 24 Regulatory          Guide        1.250,            Dedication          of 25 Commercial-Grade Digital I&C Items for Nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 1 Power Plants; and, two, SHINE Memoranda Review and 2 Deliberation/Report Preparation.
3                  A transcript of the open portions of 4 the meeting is being kept, and its requested that 5 speakers        identify      themselves            and speak      with 6 sufficient clarity and volume so they can be readily 7 heard.          Additionally, participants should mute 8 themselves when not speaking.
9                  Before we start todays meeting, I want 10 to take some time to highlight a couple of items.
11  First, one of our staff members has received a 12 significant recognition.                  Senior Staff Engineer 13 Mike Snodderly has been awarded an NRC Meritorious 14 Service Award in recognition of his exemplary 15 performance, initiative, and dedication to the 16 NRCs Operating and New Reactor Safety Programs.
17  Mr. Snodderly received this award for his lasting 18 contributions to technical support issues facing 19 ACRS.
20                  Most recently, he worked with ACRS 21 members to implement novel ways for the Committee 22 to establish and meet an aggressive review schedule 23 for the NuScale design certification application.
24  His efforts enabled the ACRS review to be completed 25 on an unprecedented schedule.
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6 1                In addition to his technical support 2 work with the Committee, Mr. Snodderly also served 3 at Commission staff level and as branch chief during 4 his 32-year NRC career.                Mr. Snodderly exhibits 5 a proven level of superior performance and strong 6 leadership that is a credit to himself and the 7 agency.
8                I also want to express our appreciation 9 to Members Halnon and Ballinger, along with ACRS 10 staff members Weidong Wang, Chris Brown, and Mike 11 Snodderly, for our well-organized visit to Region 12 II, the Byron Station, and the SHINE facility.
13 These visits help us better perform our duties as 14 ACRS members and Ive missed the years when the 15 pandemic prevented them.
16                At this time, Id like to ask other 17 members if they have any opening remarks.
18                Not seeing any, Id like to ask Member 19 Charles Brown to lead us through our first topic 20 for todays meeting.            Charlie?
21                MEMBER BROWN:          Okay, thank you.      Im 22 going to try to provide a slight summary of the 23 last meeting, since its been a while, and a little 24 bit of a calibration on how these two things fit 25 together.
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7 1                  Currently, the commercial -- youve got 2 Topical Reports, which make formal declarations, 3 and NRC reviews and they approve them.                      And it can 4 be for whatever it is, whether its a commercial 5 item thats been tested, and whatever it is, you 6 all can approve that.
7                  Right now, there is a -- then their 8 commercial certification is done under Reg Guide 9 1.164, which references some EPRI documents and 10 Topical Report, which I will mention in there, and 11 that        Topical    Report        generally          characterizes 12 critical characteristics and attributes as being 13 physical performance and dependability.
14                  And,      therefore,              the    commercial 15 certification is reviewed trying to satisfy those 16 three main functions.
17                  And    thats        kind        of    an  arbitrary 18 categorization, the way they put them together.
19 They presented that last time.
20                  Dependability is the hard one.                        The 21 first two, you can kind of test and do things.
22 The last one is a little bit more cerebral, the 23 way I view.        Its not as easy to prove dependability 24 as it is to test something.
25                  The Reg Guide 1.250 is an effort to now NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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8 1 utilize an international standard, which develops 2 something          called    safety      integrity        levels      one 3 through four, and that if the certifying -- Im 4 not going to get into the dedication bodies and 5 all that.
6                    If it comes to that process, now it is 7 available for people to use and they are proposing 8 to accept that as the -- whats the word?                                    I 9 forgot          the  words        now.              Satisfying        the 10 dependability category or characteristic, okay?
11                    So, when we reviewed this last time, 12 we didnt have the IEC or we couldnt find it.
13 So I was able to get that this time.
14                    I hope none of the rest of you tortured 15 yourself by trying to look at it.
16                    So anyway, the object now, we went 17 through that, so the effort here now, it says, 18 follow          1.250  and      they      meet        these  SIL      type 19 requirements for whoever theyre getting the stuff 20 from.
21                    In other words, if they get a computer 22 card        thats    been      used      in    numerous      projects, 23 everybody says its reliable, we dont have to do 24 anything.
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9 1 for the review of the application of the stuff in 2 the nuclear power plants.                  I may have overstated 3 it, but I think thats close enough.
4                  So, thats what they are now going to 5 rephrase or redo this time.                We made some comments 6 last time and I didnt -- I saw what you all had 7 proposed.
8                  Id like to say I remember every one 9 of them.        I did this two weeks ago.              And theyre 10 going to present that in a summary package.
11                  And I have a few questions at the end 12 so as we dont disturb the flow.                    Did I get most 13 of that right?        Okay.
14                  And weve got both the staff and NEI 15 will be presenting, for your information.
16                  MR. BENNER:              Okay, so thank you, 17 Member Brown, Chairman Rempe, and members of the 18 Committee.        Can you hear me?
19                  MEMBER BROWN:          A little closer.
20                  MR. BENNER:          People usually dont say 21 I dont talk loud.            So, but that characterization 22 is accurate.
23                  Ill step it back just a little bit, 24 because way in the past, nuclear power plants 25 typically would purchase components from what we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 call Appendix B supply.              All Appendix B --
2                MEMBER BROWN:          I forgot that part, Im 3 sorry.
4                MR. BENNER:          No, no its a good -- its 5 a good clarification.
6                MEMBER KIRCHNER:              Could you identify 7 yourself for the reporter?
8                MR. BENNER:          Im sorry.      Okay.      This 9 is Eric Benner, the Director of the Division of 10 Engineering and External Hazards at NRCs Office 11 of Nuclear Reactor Regulations.
12                So those suppliers were called Appendix 13 B because it refers to the part of the NRCs 14 regulations that contain our quality assurance 15 requirements, 10 CFR 50, Appendix B.
16                But over time, there have been fewer 17 and fewer suppliers who wish to go through all the 18 challenges of providing things to that quality 19 standard.
20                So that begat the creation of what we 21 call commercial grade dedication programs, which 22 is what Member Brown was talking about.
23                We have guidance that has been in place 24 for a while for how licensees can do this dedication 25 process.
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11 1                    Essentially,              make        their        own 2 determination that components meet the quality 3 assurance standards of 10 CFR 50 Appendix B.
4                    As that has become more prevalent, 5 there have been these generic entities that have 6 taken on some of those responsibilities so that 7 individual licensees didnt have to do all those 8 steps themselves.
9                    So like I said, weve had guidance in 10 that area and time marches on.                          As weve talked 11 about,          there    are,      in      those      criteria      are 12 expectations for determining the dependability of 13 those components.
14                    As time marched on, theres this IEC 15 standard that has the safety integrity levels that 16 gets part of dependability of components.
17                    So, this effort and this regulatory 18 guide is basically a roadmap of how licensees can 19 use that SIL certification within their commercial 20 grade          dedication        programs          to    satisfy      the 21 dependability characteristic standards.
22                    DR. BLEY:        Eric?
23                    MR. BENNER:          Yes.
24                    DR. BLEY:        This is Dennis Bley.
25                    MR. BENNER:          Hey, Dennis.
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12 1                  DR. BLEY:      Have we -- have we gathered 2 any careful analysis of how commercial dedicated 3 components have performed compared to those that 4 go      through    the      old      process?          Reliability 5 parameters or things like that?
6                  MR. BENNER:            Im going to give more 7 of a process answer and see if anyone jumps in to 8 help me.
9                  Even for commercial grade dedicated 10 items, the licensees have reporting requirements 11 under 10 CFR Part 21.
12                  And        under            those      reporting 13 requirements, if theres a belief that components 14 have        different    failure        mechanisms,      that      gets 15 reported        and  gets      transmitted        to  different 16 entities.
17                  I mean, I used to be in what is now called 18 the Operating Experience Branch, MOR, and we look 19 at all those reports as well as other failure 20 reports, and I can just say anecdotally that we 21 didnt see any what I would call weaknesses overall 22 in this commercial grade dedication process.
23                  I think at the end of the day, the 24 licensees have the responsibility.                    In some ways, 25 on one level its better because the licensee who NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 is      the    responsible      entity      for      operating    that 2 facility now is taking on the responsibility to 3 say,        yes,  this    component          meets      these  quality 4 standards that theyre held to.
5                    So, like in any process, we find design 6 defects.          We find different flaws and everything.
7 8                    But I think overall we would say the 9 commercial grade dedication process has been a huge 10 success.
11                    DR. BLEY:          Okay.        I appreciate the 12 process comments and Im sure theyre all correct.
13 14                    We  do      have      large        databases      now, 15 equipment, reliability, and it just seems like 16 somebody from industry or maybe OpE at NRC ought 17 to tease that data apart and see if we see any 18 differences.
19                    I know were using plant--specific data 20 when we look at the theories for plants, and that 21 kind of takes care of it all, but I think the larger 22 question probably deserves an answer.
23                    And I suspect the answer would make us 24 feel good.
25                    MR. BENNER:            And we certainly will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 take that back and see what kind of data we can 2 tease out in that regard.
3                  So that was the end of my expected 4 remarks.        And with that, if there are no other 5 initial questions, Ill turn it over to Dinesh 6 Taneja who is going to be giving the main part of 7 our presentation.
8                  MEMBER      BROWN:            Can  I  make      one 9 observation that I forgot on my input?                    When I said 10 Reg Guide 1.164 was the kind of umbrella that they 11 operate, 1.164 represents the EPRI document, and 12 that EPRI document covers all types of equipment, 13 not I&C.
14                  Theres a Topical Report also in every 15 document thats funneled in that covers dedication 16 of the electronic, digital electronic components, 17 programmable components.
18                  So its kind of a two-piece.              1.164 is 19 not          all  electronics.                  Its  everything.
20 Mechanical, all kinds of general stuff.
21                  And this other part now is in there to 22 cover the other stuff.                  So if you hear the two 23 things, theyre not -- theyre not both the same.
24                  One deals specifically with - they 25 mention it in the slides, so thats why I brought NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 it up now.        Thank you very much, Dinesh.
2                  MR. TANEJA:          Good afternoon, Member 3 Brown and Chairman Rempe.                        My name is Dinesh 4 Taneja.        I am the I&C Technical Reviewer in NRR 5 NRC Branch.
6                  And Ive been actually working on this 7 particular topic since 2016, since we were directed 8 by the Commission to modernize the digital, the 9 INC regulatory infrastructure.
10                  So one of the tasks that Ive identified 11 was to see if we can leverage this SIL certification 12 process which has really matured over the last 15-20 13 years into the commercial grade dedication process.
14  Next slide, Meraj.
15                  Next    slide,        please.      So,  in      this 16 activity, a number of people that have worked with 17 me and supported me in trying to get this Reg Guide 18 where we are today, Mike Eudys managing this Reg 19 Guide process, Bernie Dittman that worked with us 20 for a couple of years has retired since, David Rahn, 21 hes on the line with us, he has supported this 22 activity from my branch, and I have Greg Galletti 23 and Ayo on the vendor and QA branch that have been 24 instrumental in development of this activity.
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16 1 go to DOE but he was also instrumental in developing 2 this.        Next slide, please.
3                    So I think I can go through the material 4 that I covered back in the Subcommittee meeting, 5 which was on July 21, or I can just cover whats 6 happened since.
7                    So  its      really,          if  you  have      any 8 questions, you can get me deeper into it, but Ill 9 probably just summarize what we did during the 10 Subcommittee meeting and the feedback that we took 11 back that resulted in our documents.
12                    So next slide, please.                So the scope 13 and purpose, I think we probably discussed that.
14  This Reg Guide is really endorsing the NEI 17-06 15 Revision 1, which is the process or the guidance 16 on how to utilize the SIL certification into the 17 commercial grade dedication activities.
18                    Now,    NEI    has    been working on that 19 document as part of the IAP activity since 2016 20 and we have been basically participating in a way 21 that we have been providing constantly feedback 22 to NEI on development of NEI 17-06.
23                    So part of the endorsement is endorsing 24 the portions of the IEC 61508 standard that really 25 focuses        on  these      critical        characteristics        of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 dependability.
2                  Now, like Member Brown mentioned, that 3 the standard is like a six- or seven-part standard.
4  Its a pretty big standard.              And it covers a myriad 5 of things.
6                  And so, but for the purposes of our -
7 we are doing a limited proportion of utilization 8 of the standard.        So that portion is being endorsed 9 by this Reg Guide as well.
10                  There is the ISO IEC 17065 standard that 11 really is a framework that, like, in this case, 12 the certifying body, which is a third party that 13 does        the certification        activity,    this  is    the 14 framework that they work under.
15                  Its like their web program that they 16 abide by when theyre doing this work, providing 17 reliability,        repeatable          performance    of      the 18 certification.
19                  And also the relationship, describe the 20 relationship of this specific Reg Guide, the Reg 21 Guide 1.164.
22                  That is the guidance on how to do 23 commercial grade dedication on any commercial item 24 that has a base in a nuclear facility.
25                  And the EPRI TR 106439, I have put NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 together a timeline slide based on the feedback 2 that we got during the Subcommittee.
3                  And a lot of the questions that we were 4 getting were really related to why are we doing 5 this now and all that sort.
6                  Its fully respective of commercial 7 grade        dedication.        So    Ill      go through    that.
8 Thats near the end of my presentation, which will 9 probably link how all these documents are linked 10 together that we tried to basically establish at 11 length in the record.                Next slide, please.
12                  So I think Ive already covered the 13 background of it and all, how we came about working 14 on this document.
15                  And on this slide, what I would point 16 to is that it was not a first of its kind effort.
17  I think there was a precedence.
18                  We had previously endorsed NEI 1405, 19 which was a process for procuring commercial grade 20 laboratory calibration and test services.
21                  And  so      we    kind      of  followed      that 22 framework on how to utilize this third party 23 commercial grade processes into a -- I want to call 24 like an Appendix B type of activity.
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19 1 we talked about on this slide has already been 2 discussed.          So, next slide, please.
3                    So Ill cover a little bit of historic 4 perspective of these EPRI standards.                      And this one 5 thing here that I want to point out is that in 2016, 6 when this task was identified under the IAP, the 7 Integrated          Action      Plan,        as      part  of      the 8 modernization            of      the        IAC      infrastructure, 9 regulatory infrastructure, EPRI started a real 10 effort, and this is an EPRI document 3002011817, 11 its the efficacy of the SIL process.
12                    But this research was undertaken by 13 EPRI to take a look at the -- can this SIL certified 14 component and what do they do as part of the 15 certification?
16                    Can that be utilized into the nuclear 17 arena?          And I think some of the work thats done 18 under that, NEIs presentation that I just sneaked 19 in, theyll probably go into a little bit of the 20 detail on how they utilized that, leveraged that 21 research work in putting together NEI 17065.
22                    That was another item.                So the MP #3 23 was a task that was identified under the IAP.                          All 24 right.
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20 1 we did was that in the ANSI accreditation, ANSI 2 National Accreditation Board, I think thats what 3 ANSI stands for, ANAB is the one that does what 4 they call the -- they use the word accreditation 5 body, right?
6                  So they accredit the certifying bodies, 7 right in the USA.            In the USA, for example, Exida 8 is one of the certifying bodies that does SIL 9 certification.
10                  And    ANAB,        which        is  the  national 11 accreditation board, annually goes in and audits 12 their        activities    to    make      sure    that they      are 13 complying with ISO 17065 and they are doing the 14 work in accordance with that.
15                  So, part of this development activity, 16 the NRC staff took this opportunity to observe.
17 We did that over three cycles.
18                  We observed and conducted audits of 19 Exida and we provided some of our feedback which 20 they accepted, and they actually enhanced their 21 accreditation audit activities as a result of that.
22                  What else is on this slide I highlight?
23  Yes, and also -
24                  MEMBER HALNON:            Can I ask you a quick 25 question?
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21 1                  MR. TANEJA:          Yes, sure.
2                  MEMBER HALNON:            This is Greg Halnon.
3  When you looked at the accrediting, actually, the 4 accrediting has several aspects to it.
5                  One of them is compliance in process 6 but it also has outcomes.              Was operating experience 7 heavily looked at in that accrediting?
8                  In  other      words,          went  through      the 9 process and looked at failures in the industry to 10 come back and say, is that anywhere possibly 11 connected to inadequate certification?
12                  MR. TANEJA:          So, the other thing is 13 certification of the certifying body, whether they 14 are performing the activities in accordance with 15 their procedures, plan and procedure thats in 16 compliance with the ISO standard.
17                  And also, one of the initial key facts 18 that we gave them, that they were pretty strong 19 on looking at the processes, the accreditation 20 body.
21                  But what they call it is looking at the 22 actual technical work.                They did not really dig 23 into it much deeply.
24                  Actually, what do they do?              They really 25 look        at a  component,          SIL      certification        in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 accordance with the IEC 61508.
2                  MEMBER BROWN:          Thats ANAB that youre 3 talking ab out?
4                  MR. TANEJA:          Thats ANAB.
5                  MEMBER BROWN:          Okay, so --
6                  MR. TANEJA:          Thats really --
7                  MEMBER HALNON:            They pressed them to 8 take a look at the technical outcomes, not just 9 the process compliance, but with the technical 10 outcomes.
11                  MR. TANEJA:          Right, exactly.          And I 12 think they took our feedback and they modified their 13 checklist.
14                  MEMBER HALNON:            Okay.
15                  MR. TANEJA:            That includes some of 16 those items as part of their ongoing audits.
17                  MEMBER HALNON:            Good. Thank you.
18                  MR. TANEJA:          All right.        Next slide, 19 please.        So the regulatory bases for this Reg Guide 20 are the things here for 21.3, which really allows 21 for commercial grade dedication of off the shelf 22 items, which is basic components in the nuclear 23 power plants and facilities.
24                  And all these activities have to be 25 performed by under an Appendix B program or by what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 we call is a dedicating entity that has an Appendix 2 B program influence.
3                And  that      is    all      laid  out  in      our 4 regulation.        What is dedication?                  Whats the 5 definition of dedication?
6                And, briefly, what it really says is 7 that its an acceptable way of using a component, 8 a commercial component, as a basic component for 9 what its been dedicated.                What is boils down to 10 is      once  thou    shall        identify        the  critical 11 characteristics of the component and thou shall 12 verify those characteristics.
13                And it plays out full process and how 14 you go about verifying those characteristics.                        And 15 so there is no real guidance that are developed 16 in      basically    making        sure        that  its      done 17 consistently across the board.
18                But those are the basic regulations 19 that -- so one thing here that I would point out, 20 the Reg Guide -- hm?
21                CHAIRMAN REMPE:              I dont know if you 22 want to do it now or later, but you mentioned the 23 items that already exist.
24                MR. TANEJA:          Right.
25                CHAIRMAN REMPE:                And so, theres no NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 reason to think that if anyone would follow this 2 new Reg Guide, they wouldnt adhere to other 3 existing guidance, whether its a branch technical 4 position or an ISG.
5                I mean, all of those things still exist 6 and theyd have to adhere to it as they perform 7 this dedication process, right?
8                MR. TANEJA:          Correct.        Correct.      So I 9 think what this Reg Guide does is it supplements 10 the existing guidance, right?
11                CHAIRMAN REMPE:                Thats what I took 12 away from my read on it, but Im not an expert in 13 this.
14                MR. TANEJA:          Yes.
15                CHAIRMAN REMPE:              I want to make sure 16 that you were agreeing.                And frankly, the other 17 Reg Guide, the 1.164, it doesnt list every single 18 guidance that has to be followed, and yet its not 19 been a problem.          They still were recognizing that 20 this had to -- they had to adhere to this.
21                MR. TANEJA:          Yes.
22                CHAIRMAN      REMPE:              Just  checking.
23 Thanks.
24                MR. TANEJA:        So I think what I was going 25 to point out is that the draft of the Reg Guide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 that we had here during the Subcommittee meeting 2 did not have the direct base as the Appendix B, 3 Criterion VII.
4                I think the markup that we gave you, 5 we added that Criterion VII to the regulatory bases 6 of the Reg Guide.            So thats one change that we 7 did make.      Next slide, please.
8                So, nothing really -- we did not have 9 to -- the changes that we made as a result of the 10 Subcommittee meeting to the Reg Guide were not at 11 the level that we needed to go back for public 12 comments.
13                So    the      public        comments that        we 14 discussed during this Subcommittee meeting and how 15 we dispositioned them and any impacts to the Reg 16 Guide were already incorporated in the draft guide 17 that we shared at that time.
18                So nothing has changed since the -- and 19 we did not have to go back and ask for public 20 comments and there are no new comments.
21                So I think really there is, unless there 22 is any interest in the comments that we got from 23 public, we dispositioned them adequately, and any 24 impact to the Reg Guide, we incorporated them and 25 we did not really have any follow-up on that area.
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26 1                  MEMBER BROWN:          I presume the main one 2 you put in there was the 10 CFR Appendix B addition.
3                  MR. TANEJA:          Criterion VII.
4                  MEMBER      BROWN:          Which      was  a    quick 5 summary about documentary evidence, et cetera.
6                  MR. TANEJA:        Yes.      Next slide, please.
7  I think the next few slides, I probably want to 8 skip that.            Lets skip down to the historic 9 perspective.          I think that was a lot of the 10 questions that we got during the Subcommittee --
11 next slide -- were all about why are we doing this 12 and what we are doing here and --
13                  MEMBER BROWN:          Can you back up for one 14 minute?
15                  MR. TANEJA:          Yes.
16                  MEMBER BROWN:          Back up a slide just for 17 that --
18                  MR. TANEJA:          Sure.
19                  MEMBER BROWN:          My take on your position 20 when I went through, and correct me if Im wrong, 21 but        were    largely      process            oriented,        not 22 necessarily technically oriented, and its 23 reflected in what I see.
24                  Youve got to do it.                      You cant 25 extend          the  time      period          about    which      you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 recertify.            Youve          got        to    follow      the 2 endorsements.            Youve got to have certain 3 things.        But its process oriented, its not 4 just technical requirements are this or that.
5                  MR. TANEJA:            Yes.        These      are 6 clarifications.
7                  MEMBER BROWN:            Ive got it.          Thank 8 you.
9                  MR. TANEJA:            So      our  regulatory 10 positions are not exceptions.                        What happened 11 is, we endorsed Rev. 1 of 1706.                          So when we 12 received the Rev. 0, we provided a set of 13 comments to NEI, which they incorporated.
14                  So, really, Rev. 1 addressed all of 15 our concerns.        But here, I think these are more 16 like highlighting the areas that I think one 17 was a little vague of the periodicity of doing 18 the oversight.          They said its got to be done 19 at      least    hours,      and      thats        one  of      the 20 clarifications.
21                  And the other was that make sure that 22 the certificates that you do get, I think we 23 hear that there are some counterfeits out there 24 on the market, that you really need to pay 25 attention        to    the      generalness            of    those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 documents.
2                  If    youre        going          to    utilize          a 3 certificate, make sure that it is a good one, 4 not just some entity.
5                  So I think those were just kind of 6 safeguards, those that needed clarification.
7  Okay, so, next slide, unless you have any 8 questions.
9                  So  these        were        the    five    public 10 comments that we go and their dispositions.
11 Nothing new there.              So, next slide.
12                  So here, I think is where I think 13 probably well answer most of the questions that 14 were raised during the Subcommittee meeting.
15                  And the information that I have here 16 really is coming from Reg Guide 1.64s endorsed 17 document.
18                  Those are the EPRI document that we 19 endorsed.        Has a pretty good history of where 20 the commercial grade dedication of items and 21 services.
22                  And what I did is Ive taken the parts 23 that        are of  interest          to      the    --  from      the 24 regulatory framework.
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29 1 of things, that document, but I just captured 2 a few.
3                  So this effort really goes back to 4 the 70s when there was -- Appendix B suppliers 5 were disappearing and during the heydays of the 6 nuclear,          there      were        people      that        were 7 disappearing and the concern was can we take 8 these commercial items and what do we do with 9 them, right?
10                  These        commercial            grade        item 11 discussions started back then when we didnt 12 have Appendix B suppliers.
13                  In 76 the first standard that came 14 out was the ANSI 18.7 that was endorsed by the 15 NRC as Reg Guide 1.33, which addressed the end 16 user of the commercial off the shelf item.
17                  So, in 78, Part 21 basically was 18 revised.          That required a commercial grade 19 dedication before it could be used as a basic 20 component.
21                  It became a regulatory requirement in 22 78 that if youre going to use it as a basic 23 component, thou shall dedicate it, right? In 88, 24 EPRI 5652 issued that really provided a methodology 25 of      how    you  go    about      doing        commercial    grade NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 dedication.
2                    In 89, NRC issue a generic letter, 3 89-02, that conditionally endorses NP 5652.                          Next 4 slide, please.
5                    In  91,      generic          letter  91-05      was 6 issued.          And that basically pointed to 10 CFR 7 Appendix B, applicability to commercial grade 8 dedication process.                But thats really going to 9 be how it imposes the QA requirements onto the 10 process itself.
11                    So in 94, EPRI issued TR 102260, a 12 supplemental guidance to the NP 5652.                      But these 13 two documents, the NP 5652 and EPRI TR 102260, the 14 Rev. 1 of that is the front vision that they gave 15 it a new document or that endorsed by Reg Guide 16 1.164.          That is in a pre-document --
17                    MEMBER BROWN:          Thats not the 106 --
18 whatever the number is.
19                    MR. TANEJA:          That document, they gave 20 it a new number which basically is a division one 21 to this, and NP 5652.                  So what they did is this 22 is a supplemental guidance, right?                        The NP 5652 23 and the supplemental guidance, revision one to 24 that, became the new EPRI doc.
25                    MEMBER      BROWN:          And    thats    106439 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 1 youre talking about?
2                  MR. TANEJA:        No.
3                  MEMBER BROWN:          Or is that the 22 --
4                  MR. TANEJA:        Thats a document that we 5 endorsed by Reg Guide 1.164.                      Okay, thats the 6 3002002982.        Right.        Yes, thats why its so 7 confusing and I thought Id put it in a timeline 8 because theres just so many different documents 9 and so many things happening, right?
10                  So in 1996 is when EPRI 106439 was 11 issued.        Now, this document is the one that 12 actually provides guidance on how to do commercial 13 grade dedication of digital items, the PLCs and 14 the computerized items and the digital devices.
15                  And this is where it supplements the 16 EPRI 5652, right?          And in the new standard, this 17 is called out in section 14.1 of the EPRI guidance 18 document.
19                  This section focuses on the digital 20 under that document.            So the EPRI TR 106439 was 21 endorsed by the NRC by a safety evaluation in 1997.
22  In 2011, a second paper was generated.
23                  So we have these bunch of documents, 24 so the issue must have been there, right?                The staff 25 issued a paper saying that, hey, we should have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 a record on commercial grade dedication process.
2                    Right?      Because we are noticing these 3 by generic letters and safety evaluations.                                So 4 thats really where the development of the Reg Guide 5 1.164 effort was initiated.                    Next slide, please.
6                    So in 2014, EPRI issued the 3002002982.
7  That is, and its a mouthful, that division 8 1205652, and a supplement supporting document here, 9 102360.
10                    And in 2016 is when the modernization, 11 project number three, that was identified as part 12 of      the    IAP  effort,      Commission          direction      for 13 modernizing the I&C infrastructure.
14                    And that effort that was identified was 15 how      can    we  leverage        the    I&C      61508  into      the 16 commercial grade dedication activities?
17                    Like I said earlier, concurrent with 18 that, EPRI started their research work, and I think 19 in EPRIs presentation, in their presentation I 20 think theyll go over that a little bit, how they 21 use that research and do that.
22                    In 2017, Reg Guide 1.164 was issued that 23 endorsed the EPRI 3002002982.                      In 2021, December, 24 is      when    we    received        NES    1706      Rev  One      for 25 endorsement.            And today we are in front of you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 trying to get this document endorsed via Reg Guide 2 1.152.
3                    So it has had a long history.              Its been 4 evolving,          but  the    nuclear        industry      has      been 5 dedicating this item for a number of years now.
6                    And    my    personal          experience        with 7 dedication of digital items goes back to the early 8 90s when we dedicated single loop controllers that 9 were made by, I forget now, I think Fisher Porter 10 or somebody like that and then (audio interference) 11 that were digital recorders that replaced pen and 12 paper.
13                    And they were commercially dedicated 14 back in the early 90s, so those efforts - and we 15 used this guidance in EPRI 106439 in performing 16 those dedication efforts.
17                    But thats my presentation.                Are there 18 any questions?          Id be more than happy to entertain 19 them.          And I have, I think, hopefully, people 20 online with me, Greg was there, QA branch, so any 21 questions.
22                    MEMBER MARCH-LEUBA:                This is Jose.
23                    MR. TANEJA:          Yes.
24                    MEMBER      MARCH-LEUBA:              Just    for      my 25 education, as you say in your presentation, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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34 1 whole thing was started in the 70s when people 2 couldnt buy spare parts, right?                    Has this evolved 3 now?          So if Im designing a new reactor from 4 scratch, can I use commercial parts for the guide?
5  Or is this only -- is this only for spare parts 6 or can I build a new reactor with them?
7                  MR. TANEJA:          Well,        our  regulatory 8 framework doesnt distinguish between a commercial 9 part or an Appendix B supplier part. What it says 10 is that if you are going to use a commercial 11 off-the-shelf as a basic component, thou shalt 12 dedicate it and thou shalt follow this process of 13 dedicating it.
14                  So a dedicated item by de facto means 15 its equal to an item produced under Appendix B.
16  Its as good as that.
17                  MEMBER MARCH-LEUBA:              So I could design 18 a brand new reactor --
19                  MR. TANEJA:          Just using commercial 20 parts, if you dedicate it.
21                  MEMBER MARCH-LEUBA:                  Right.      Okay.
22 Thank you.
23                  MR. BENNER:          Now, theres a pragmatic 24 aspect that I could go someplace and buy a vessel 25 and then say I'm going to dedicate it.                      But I just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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35 1 dont envision that being how a reactor vessel comes 2 to play.        So I think its for this to be an avenue, 3 its        because  there      is    a  commercial      --    like, 4 breakers.        I mean, its stuff that you just buy 5 commercial grade.            I mean, I think theres still 6 going to be plenty of major components in any new 7 power plant that are going to be -- the only reason 8 theyre going to be there is if theres an Appendix 9 B supplier making that.
10                  MEMBER      MARCH-LEUBA:              The  guide        is 11 focused on Digital I&C.              They still have commercial 12 parts or commercial -- so I&C components that would 13 be very difficult to go under Appendix B?
14                  MR. BENNER:            Yes.        Well, I wouldnt 15 say difficult.        Its just, is there a market there?
16    I mean, to get that be certified as an Appendix 17 B supplier, you subject yourself to NRC inspections 18 and other things.
19                  And I think theres just not enough 20 customers that these vendors want to do that.
21 Theyre like, hey, I got commercial stuff that I 22 sell        to  all  these      highly        safety    significant 23 industries and its good enough for them.
24                  So, nuclear, if you want to use mine, 25 you have to find a way to get my stuff.                        Im not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 going to come to you.
2                    MEMBER BROWN:          I was going to try to 3 provide some perspective on that.                          Because most 4 of you all would probably assume Im not great on 5 what I would call all third-party type stuff.
6                    I  mean,      but      from      an  experience 7 standpoint          in  the      electronics          world,  Im      not 8 talking about pipes and valves and gears and stuff 9 like that, which are big parts that you can do things 10 with,          theres      thousands            of    parts    on        a 11 computer-based module, PLC, and thats aside from 12 the        million    chips        weve        got    inside        the 13 microprocessor, inside the logic in it.
14                    And you cant test all of it.                Theres 15 just no way to do it.              Youre faced with stuff in 16 the        military    world        with        MILSPEC,    military 17 specification, parts.
18                    There, theres a big market.                A lot of 19 ships, a lot of army units, a lot of stuff goes 20 out in the field.            Theres a lot of stuff that gets 21 built all the time.
22                    So when you build a transistor for an 23 integrated service or a log unit or any piece of 24 equipment thats going into the field, theyll 25 build 10,000 pieces on an assembly line.
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37 1                    Theyll test 100.              And if no more than 2 three fail, the whole lot passes.                        I just picked 3 a number out of there, but thats the ballpark.
4                    Thats      what      you      live    with  in      the 5 electronics world.              So I appreciate this approach 6 because I think thats what were facing largely.
7                    We need to go out and find out are these 8 parts that people are using, PLCs whatever you want 9 to call them, commercial parts, theres got to be 10 a better way to do this.
11                    I think theres some ways that I mention 12 later in my questions, but I just wanted to put 13 it      in    perspective        so    that        everybody    would 14 understand how you build stuff in the electronics 15 world and how the piece parts do get tested, because 16 they dont get 100 percent tested.
17                    Im going to save my other question for 18 everybody elses. Im going to save mine until after 19 NEI.        I dont want to -- I want to keep the whole 20 thing moving and get both parts in and then Ill 21 have my other questions.                    It relates more to my 22 letter, the letter that I generated.
23                    MEMBER BIER:          So --
24                    MEMBER BROWN:          Yes, Vicki, go ahead.
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38 1 area, but just from things Ive read in the press 2 and other areas like voting machines or military 3 equipment, whatever, theres a lot of concern about 4 parts that might come already compromised from 5 Chinese manufacturers or other external sources.
6  And has that been addressed?                How big of a concern 7 is that in this context, et cetera?
8                MR. TANEJA:            Right.        So,  in      our 9 regulatory framework in general, we have what we 10 call an SDOE, secure development and operational 11 environment.
12                And in that effort, not only we require 13 it, but also our Appendix B program and the 14 commercial grade dedication program, one of the 15 requirements is to assure that each part that you 16 are using, right, are coming from reliable sources.
17                And there is a large awareness in the 18 industry of these so-called compromised parts that 19 are getting into their products.                        They have a 20 person who is building these so-called digital 21 devices, they have as much at risk as a user does.
22 So theres a very high awareness, very concerned.
23                MEMBER BIER:          Okay.        Thank you.
24                MEMBER BROWN:          Any other questions at 25 this point?      Yes?
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39 1                MEMBER KIRCHNER:            Dinesh, in practice, 2 lets pick on some critical components, like the 3 reactor protection system.
4                How does this all work out?              In my mind, 5 if its under Appendix B the umbrella, so how do 6 you feed the parts of a larger system or component?
7                MEMBER BROWN:          Well, can we answer that 8 question after NEI?              That is a very pertinent 9 question.      I wanted to deal with that in a unified 10 discussion.
11                MEMBER      KIRCHNER:              Thats  my      only 12 question.
13                MEMBER      BROWN:            No,    thats    good.
14 Thats very good.
15                MEMBER MARCH-LEUBA:                  For the staff, 16 they prove that their microphones are there.
17                MEMBER BROWN:          So if theres no more 18 questions for the staff, NEI can come on up and 19 -
20                MR. BENNER:          Yes, the staff is going 21 to stay here.        Whatever questions come up, were 22 still available to take them.
23                MEMBER BROWN:          Does he need the center 24 seat or is the right hand or left-hand seat okay?
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40 1 online that can share the slides?                      Wonderful.
2                  MR. CAMPBELL:          Its actually going to 3 be the primary presenter today.                      Id just like 4 to make a couple of introductory marks and then 5 well --
6                  MEMBER BROWN:          Turn on the mic.
7                  CHAIRMAN REMPE:            Go ahead and ask them 8 to share their slides, too.
9                  MEMBER BROWN:          When its green its on.
10                  MR.      CAMPBELL:                  Im  red-green 11 colorblind so --
12                  MEMBER BROWN:          Touch it again.
13                  MR. CAMPBELL:          There we go.
14                  MEMBER BROWN:          Pull the mic forward.
15                  MEMBER MARCH-LEUBA:                Say your name, 16 please.
17                  MEMBER BROWN:          Pull the mic -- pull the 18 mic toward you.          Thats it.          Thank you.
19                  MR. CAMPBELL:              Okay, can everybody 20 hear me?        And it looks like Andy Nack will be our 21 primary presenter today.
22                  My name is Alan Campbell.                  Im the 23 technical advisor with NEI.                    I lead our digital 24 I&C working group and multiple task forces that 25 we have underneath that digital I&C working group.
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41 1                So I wanted to start by thanking the 2 ACRS Committee today for inviting NEI to speak 3 regarding our work on digital I&C commercial grade 4 dedication.
5                The approach that will be presented 6 today supports the replacement of aging analog 7 systems in the operating fleet with digital systems 8 that enhance the safety and reliability of our 9 nuclear power plants.
10                This process provides a pathway for the 11 use of commercial digital I&C technology that has 12 been developed specifically for functional safety 13 applications.
14                By using this approach, we will provide 15 a consistent oversight process of commercial off 16 the shelf components and are able to draw from the 17 operating experience of other safety critical --
18 I want to thank the NRC staff for their review and 19 comments of NEI 1706 and their participation in 20 multiple accreditation audit observations that 21 demonstrated the adequacy of both SIL certification 22 and NEI 1706 oversight processes.
23                But at this time, Ill turn over the 24 presentation to our primary author of NEI 1706, 25 Mr. Andy Nack, and hell go over the processes.
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42 1 Thank you very much.
2                  MR. NACK:        All right.        Thank you, 3 Alan.        As Alan said, my name is Andy Nack.                  Im 4 part of the NEI team.
5                  So, what weve got today is a 6 presentation that is a little bit abbreviate 7 version of what we presented previously to the 8 Subcommittee.
9                  This slide here is just kind of a 10 placeholder showing you where the document is 11 available on the NRCs website with a quick summary 12 of the scope that reflects what Alan just shared 13 in terms of the overall goal of this document, the 14 purpose of the document.
15                  So one of the things we wanted to do 16 today is to get a little bit more into what this 17 safety integrity level ecosystem is and how it 18 already exists and how were just trying to leverage 19 something that is already being utilized in other 20 high risk industries.
21                  So this safety integrity level concept, 22 it was already mentioned that theres four levels.
23 24                  So its level one, or SIL one, would 25 be for the least risky application going all the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 way up to SIL four, which is the highest risk.
2                And so typically within a system that 3 is certified or developed to a SIL level, theres 4 three main types of components that are going to 5 be involved.
6                And thats what were showing here with 7 the sensor, the logic solver, and some type of an 8 on/off actuator.
9                And so theres manufacturers of these 10 components that are using the IEC 61508 standard 11 to ensure that theres systematic integrity and 12 the appropriate level of reliability and hardware 13 fault and tolerance based on what the particular 14 skill is that their goal is to achieve.
15                And so, across the bottom Ive got some 16 example manufacturers that use IEC 61508 to design 17 and manufacture products.
18                Once these manufacturers have the 19 product ready for certification, they contract with 20 Exida or TUV Rheinland or various other certifying 21 bodies to come in to evaluate what they have done 22 in their efforts to design and develop these 23 products to be in compliance with 61508.
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44 1 theres a market in high risk industries such as 2 oil and gas or chemical processing or other 3 industries that are going to, kind of like was 4 discussed about the military, is going to buy a 5 large quantity of the products that they design 6 and develop and sell.
7                So these certified bodies are also then 8 accredited by whichever accreditation body is 9 appropriate for the country theyre located in.
10                So for example, I just have DakkS at 11 the top, because thats the German accreditation 12 body, and that would be who accredits TUV Rheinland 13 and the other two entities.
14                And ANAB would be the entity here in 15 the US that accredits Exida.
16                And earlier, it was mentioned about the 17 EPRI research.        So these items here are summaries 18 of what the conclusions were from that research 19 that we were able to build upon when we were 20 developing this guidance.
21                First one was that the SIL 22 certification aligns well with EPRI TR 106439.
23                So this is where you can really get into 24 the nuts and bolts of the types of activities, the 25 design techniques, the features that were being NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 built into the products, align well with what was 2 already in the existing process for nuclear in this 3 TR 106439 document.
4                Then the certifying bodies are standard 5 and rigorous, reliable evaluation process.                  The 6 CBs, so thats the CBs.
7                The ABs, the accreditation bodies, 8 ensures the CBs are consistent and trustworthy.
9 The failure data indicates reliable operation and 10 SIL certified equipment.
11                And SIL certifications are an accurate 12 indicator of reliability.              So to accomplish these 13 conclusions, EPRI did an in-depth dive into what 14 these certifying bodies and these accreditation 15 bodies, what they do, what their processes are.
16                And the interesting aspects with the 17 final two conclusions was that they actually did 18 gather operating experience and compare it to what 19 the certifying bodies had certified.
20                So they were able to see in the data 21 that the actual failure rates of the certified 22 equipment were -- the certifications were actually 23 conservative in terms of the actual failure rates 24 in the field.
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46 1 situation where they were able to see that the 2 failure rate was higher than predicted and 3 certified, and it was actually a way that they were 4 able to go in and find a systemic issue with the 5 manufacturing process.
6                So part of the certifying bodies 7 evaluation process already included comparing 8 actual operating experience against what the 9 predicted failure rates were and when the actual 10 failure rates are higher than whats predicted, 11 they go in and figure out why.
12                And it is a very useful indicator of 13 finding that systematic issue with the 14 manufacturing.
15                They were able to in that instance 16 correct it and see the reliability numbers fall 17 back down into the range of being predicted.
18                DR. BLEY:      Andy, this is Dennis Bley.
19                MR. NACK:      Yes.
20                DR. BLEY:      Im glad to hear all this.
21  We heard earlier part of the reason weve gone 22 to this process is that manufacturers didnt want 23 to dance through all the hopes that NRC applies 24 for inspections and the like.
25                Do these accreditation bodies or the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 certification bodies have agreements with the 2 vendors that when they find something curious like 3 you just talked about they can get in and rummage 4 through the vendors data?
5                  MR. NACK:        Yes.      So the certifying 6 bodies operate using ISO 17065.                    And that standard 7 drives contractual agreements between the 8 certifying body and the particular manufacturers 9 where they make commitments like that, that they 10 are - if - so if the manufacturer is wanting to 11 carry a particular CB certification, they have to 12 agree to provide that type of information to the 13 CB.
14                  DR. BLEY:        Okay.      Just thinking out 15 loud now, which is a dangerous thing to do.                        This 16 kind of implies that from a component vendors point 17 of view, the NRC process puts a lot of overhead 18 on them whether or not they have problems, and here 19 theyre willing to allow outside involvement in 20 their systems if theres indications of a problem.
21  Is that a fair statement?
22                  MR. NACK:        Yes, I would say thats 23 correct.        And I think what was mentioned earlier 24 about what the size of the potential market is for 25 them to sell them to is a major differentiator.
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48 1                DR. BLEY:      Yes, okay, thank you.                You 2 have spoken to one of the questions I asked NRC 3 earlier.
4                Are the reliability data that back up 5 this process available to people in the various 6 industries?      Or is it proprietary to the vendors?
7                MR. NACK:        Its available.          So Exida 8 is the CB Im most familiar with.                  I know that they 9 use various sources for their reliability data, 10 some of which are probably the ones that youre 11 aware of.
12                But they also collect data as theyre 13 doing their certification evaluations of 14 manufacturers.
15                And Exida actually offers a platform 16 that provides access to a lot of that data for use 17 through someone creating a contract with them and 18 gives access to all the data that they have in terms 19 of operating experience.
20                DR. BLEY:      Okay.        Interesting.        Thank 21 you.
22                MR. NACK:        Sure.      All right.      And so 23 now, well jump into looking at the existing process 24 for accepting or justifying equipment and then 25 looking at how this new NEI 17-06 guidance enhances NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 that process.
2                  So this right now is what the process 3 would look like to go through qualifying and 4 dedicating equipment for use in a nuclear 5 application.
6                  And so, the next slide, we overlay where 7 the SIL certification provides some enhancement 8 here.        So the work that is being done is a 9 qualification part of the process where youre 10 determining suitability of the design for the 11 application, looking at the systematic integrity 12 aspect of that evaluation is covered by the fact 13 that the manufacturer is adhering to IEC 62508.
14                  Then getting into the commercial grade 15 dedication phase, this is where you gain the ability 16 to utilize the SIL certification in place of what 17 would have needed to be covered using typically 18 a commercial grade survey to address the 19 dependability critical characteristics.
20                  Then that gets you to where it says 21 implementing the method one acceptance strategy, 22 where youre still completing the commercial grade 23 dedication using or completing the commercial grade 24 dedication process for the critical 25 characteristics that fall into those categories NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 of performance and physical critical 2 characteristics that can be typically evaluated 3 by some type of testing.
4                    DR. BLEY:        Andy, its Dennis Bley 5 again.          We talked about availability of the data 6 to the folks who are building components.
7                    What about the people who are users of 8 those components, either a utility company whos 9 going to buy a new plant or a US reactor vendor 10 whos looking to buy components to put into their 11 plant?
12                    Do they have access?                And lets include 13 the NRC as well.            Do they have access to the data?
14                    MR. NACK:        They would be able to 15 achieve the same access by engaging with Exida that 16 a manufacturer would.
17                    And so the way the SIL ecosystem works 18 is that the end user is actually, or some 19 integrator, is actually responsible for putting 20 the different components together in a manner that 21 still achieves the particular reliability targets 22 required for the application.
23                    So the failure rates are still 24 applicable to the end user, maybe even more so than 25 the manufacturer, because the end user is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 responsible for making sure that the reliability 2 targets are still achieved when they put all the 3 different pieces together.
4                DR. BLEY:      So that makes sense.
5                MR. NACK:      So theyre looking at the 6 system reliability instead of just the individual 7 component reliabilities.
8                DR. BLEY:      If Im an end user, do I have 9 a contractual or other obligation to provide 10 failure data I collect after Im using the 11 components back to this process?
12                MR. NACK:      I wouldnt say 13 contractually.      I think in that type of a scenario, 14 it makes a lot of sense for the end user to feedback 15 failure data back to the manufacturer.
16                Because its definitely in the interest 17 of the end user to have the most accurate failure 18 data as possible, so they would want to provide 19 that information back to the manufacturer that 20 would then get integrated into the larger data set.
21                DR. BLEY:      Okay, thanks.
22                MR. NACK:      Okay.      And so now moving 23 into a more detailed step through of what this NEI 24 17-06 guidance really is and the nuts and bolts 25 here.
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52 1                And Ive included an example 2 manufacturer, Yokogawa, and an example certifying 3 body of Exida, just as a reference.
4                And then over on the left side of the 5 screen, Ive just noted that thats the Appendix 6 B QA program that the dedicating entity would be 7 operating under.
8                So starting out, step one, youre 9 definitely going to need to identify what your 10 requirements are for your application.
11                And then youre going to confirm that 12 the equipment that youre evaluating is certified 13 in a manner that encompasses what your requirements 14 are.
15                Then you move into identifying what the 16 critical characteristics are for the equipment as 17 well as identifying critical characteristics of 18 the service that the CB is providing when theyre 19 providing their certification.
20                Because I guess its important to note 21 here, theres actually two separate commercial 22 grade dedication activities happening.
23                One is for the actual item that the 24 manufacturers providing and one is a dedication 25 of the service that the CB is providing.
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53 1                Then youre going to confirm that the 2 certifications that the CB are providing are within 3 the scope of what their accreditation covers.
4                And then youre able to complete the 5 dedication of the CB service using that 6 accreditation.
7                Then well talk more detail later about 8 how an accreditation body or how an accreditation 9 body and CB together get their initial approval.
10                And so that approval process happens 11 before this to where that approval is part of what 12 is necessary to complete this dedication of the 13 service.
14                Then Step 7, we get into being able to 15 use the certification.              So the reason for the 16 dedication of the CB service is so that the 17 certification thats been provided by that CB now 18 has the necessary pedigree to be used to - be used 19 to determine the acceptability of the dependability 20 critical characteristics.
21                Then the final step, Step 8, youre 22 using traditional commercial grade dedication 23 methodologies such as Method 1 Testing to determine 24 the acceptability of the physical and critical 25 performance characteristics.
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54 1                And so that walks you through what the 2 actual process is that this guidance is utilizing.
3 4                And then the NEI 17-06 does also include 5 some indications of how to select SIL certified 6 equipment.
7                And just at a high-level summary, 8 youve got the equipment, must be able to prove 9 -- to perform the required functions for the 10 application.
11                The equipment must be certified for the 12 appropriate SIL level.            So for an example, if its, 13 if the application requires SIL two, the equipment 14 must be certified to two or higher.
15                And the required safety functions must 16 be within the scope of the safety functions 17 identified on the certificate.
18                And just as an example of this, theres 19 several actuators that are certified that its 20 important to look at what details of their actuation 21 are actually covered by the safety function thats 22 listed on the certificate.
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55 1 the on/off range of that actuators functionality.
2                So heres what I was referring to a 3 minute ago about the different pathways to 4 approving the CBs.
5                So before walking through the process 6 of utilizing this NEI 17-06 methodology, the CBs 7 need to have been evaluated by the industry using 8 one of these two pathways.
9                One is this accreditation only pathway, 10 where the accreditation body, its been observed 11 that they utilized sufficient rigor to look at the 12 CBs processes but also their scheme.
13                And the scheme is whats specifically 14 tying into the IEC 61508 requirements that are more 15 the technical type of requirements in nature.
16                And the second pathway is a situation 17 where a little bit more rigor does need to be applied 18 to the assessment of the certification scheme.
19                And this is an example of what we 20 encountered with ANAB during our observations was 21 that during the initial observations, ANAB needed 22 a little bit more rigor in terms of how they were 23 evaluating the scheme that the certifying body was 24 using.
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56 1 supplemental checklist that the nuclear industry 2 can directly use interacting with the CB directly 3 to supplement what the accreditation body has done 4 in terms of looking at the processes.
5                  So one of these two paths are available 6 to gain the initial approval of the CBs for use 7 within this process.
8                  MEMBER HALNON:            Andy, this is Greg 9 Halnon.        How often is the accreditation process?
10                  MR. NACK:      The accreditation or the AB 11 at least in what we interacted with, with ANAB and 12 Exida has some type of an activity every year.
13                  I think the actual accreditation cycle 14 is every two years but even on the off years, the 15 accreditation body does at least a supplemental 16 observation process that looks similar to a full 17 accreditation activity but I guess is a little bit 18 abbreviated.
19                  So theyre doing something every year.
20                  MEMBER HALNON:            Great. Do you know 21 how long the certification process takes from -
22 I hate to say the site visit but from the actual 23 accreditation?          A week?        Two weeks?
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57 1 of information remotely ahead of time.
2                So a lot of the work is done up front 3 of reading the procedures and figuring out what 4 they want to look at.
5                So then the actual on-site activities 6 are something more like the one-week range.
7                What we saw was the accreditation body 8 utilized separate teams and so it was more like 9 each team spent one or two days looking at their 10 particular area.
11                And they might be operating in 12 parallel.      So like one team would be more focused 13 on the procedures and the administrative aspects 14 of 17065 while the other team was more the technical 15 aspects, looking at how the manufacturer was 16 qualified to do the work and how theyre applying 17 their scheme.
18                MEMBER HALNON:            Okay. Who is on the 19 accreditation visit?            Are they consultants?              Are 20 they industry folks?            What is the makeup of the 21 team that does the accreditation?
22                MR. NACK:      So, ANAB has a process that 23 they use to qualify people.                  So theyre 24 representatives of ANAB.                I dont know how they 25 necessarily structure them in terms of, are they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 direct employees of ANAB?                I dont know.        They may 2 be operating as contractors of ANAB.                      But they have 3 been evaluated by ANAB as qualified to perform the 4 particular accreditation activity.
5                  MEMBER HALNON:            Okay, so they train 6 their own folks.
7                  MR. NACK:        Yes.
8                  MEMBER HALNON:            The accreditation 9 processes.
10                  MR. NACK:        Yes.
11                  MEMBER HALNON:            Thank you.
12                  MEMBER BIER:          Another question.            Are 13 the accrediting bodies currently all governmental 14 organizations or no?
15                  MR. NACK:        No, theyre not.
16                  MEMBER BIER:          Okay.        So theyre 17 commercial or non-profit or do you know what the 18 status is?
19                  MR. NACK:      I dont know.            Alan, do you 20 know?        I dont know.
21                  MEMBER BIER:          Its not super 22 important.        Im just curious.
23                  MR. NACK:      Im not sure organizational 24 wise the structure.
25                  MEMBER BIER:          Thanks.
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59 1                  MEMBER HALNON:            This is Greg again.
2                  MR. CAMPBELL:          ANAB is associated with 3 the answer.
4                  MEMBER HALNON:            So if you make the 5 analogy to like ABET, the accreditation board for 6 engineering technology programs, there are 7 industry and academics and other folks who are 8 involved in that field that give their time to the 9 accrediting board itself.
10                  And thats what I was trying to find 11 a word.        They draw their people from.          That might 12 be just good to look up if you would just to let 13 us know.        Because it speaks to, one, how 14 independent they are and how consistent the process 15 is year after year.            Because if you get different 16 people every single time, there are plusses and 17 minuses.        Theres a fresh look but you also get 18 less experience.
19                  MR. NACK:      Yes, and the other umbrella 20 that all the accreditation bodies are under is the 21 international accreditation forum where different 22 accreditation bodies evaluate each other.
23                  So youve got that dynamic going on as 24 well that tries to maintain a standard application 25 of what the accreditation bodies are doing.
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60 1                All right.        Then NEI 17-06 also 2 provides some guidance on how the dedicating 3 entities would need to adjust their QA program to 4 be able to make sure its set up in an appropriate 5 manner to utilize this process.
6                And this is just a summary of the areas 7 that it provides direction for it to be adjustments 8 made in these procurement documents, what the tasks 9 are associated with the digital dependability 10 evidence and the QA evidence for digital 11 dependability and their correction action program.
12                So details are provided in the NEI 13 guidance for those areas.              And then this is whats 14 already been touched on a little bit, but this is 15 where the nuclear industry will continually provide 16 oversight of the accreditation bodies and the 17 certification bodies on an ongoing basis, kind of 18 trying to be able to look at what was just being 19 asked in terms of are they maintain their level 20 of rigor and are there people that are out in the 21 field doing the evaluations maintaining the proper 22 level of training and evaluations and such?
23                And so, were currently in discussions 24 engaging with NUPIC as a possibility for being the 25 entity that would take on this task.              But were NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 kind of in a situation right now where NUPIC is 2 interested in waiting on seeing the NRC endorse 3 the process and then it looks like they probably 4 would be interested in getting more involved.                      So 5 --
6                  MEMBER BROWN:          Excuse me, I keep 7 forgetting what NUPIC alphabet soup means.
8                  MR. NACK:        Yes, its, I believe its 9 nuclear -
10                  MEMBER BROWN:          Im not the only one.
11                  MR. NACK:        Yes, Nuclear Utility 12 Procurement Issues Committee.
13                  MR. GALLETTI:          Andy, Ill just chime 14 in.        This is Greg Galletti from the NRC group.
15 It just stands for Nuclear Utility Procurement 16 Initiative Corporation.
17                  MEMBER BROWN:          Thats not an NRC 18 operation.
19                  MR. GALLETTI:          No, its a consortium 20 of licensees.        So they would -
21                  MEMBER BROWN:          Go ahead.
22                  MR. GALLETTI:          I was just going to say, 23 its an organization based up of nuclear, 24 commercial nuclear licensees and their 25 representatives sit on the committee.
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62 1                MEMBER BROWN:          Okay, so the oversight 2 by U.S. NRC really follows.                It says NRC licensees 3 or designees, not NRC body going out and doing this 4 oversight.      Is that the way you read this?
5                MR. NACK:        Well, it can be.          So the 6 NUPIC, the utilities are ultimately responsible 7 for the oversight but the NRC has the option to 8 participate as they see fit.
9                MEMBER BROWN:          Has that process been 10 defined yet or is that still in play based on NUPICs 11 hesitancy on jumping in?
12                MR. NACK:      Well, the fundamentals are 13 as I described in the two pathways for getting the 14 approval of the CBs and the Abs using the 15 accreditation or the accreditation plus the scheme 16 evaluation.
17                And the NEI 17-06 has the additional 18 checklist included in it.                That would be the 19 process that the oversight would use to do the 20 evaluations.
21                So the only open issue right now is are 22 specific licensees performing that or will they 23 jointly perform it under the NUPIC entity?
24                MR. ODESS-GILLETT:                Andy, can I 25 supplement your response by saying that the NEI NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 17-06 says that the licensee or its designee is 2 responsible for this oversight.
3                  MEMBER BROWN:          Who spoke just now?
4                  MR. ODESS-GILLETT:                That was Warren.
5  Im sorry, Charlie, Warren Odess-Gillett.
6                  MEMBER BROWN:          Oh, okay.      Thank you.
7                  MR. ODESS-GILLETT:                Yes. So that 8 really is, I think, US NRC licensee as you were 9 asking, Charlie.
10                  MEMBER BROWN:          Okay, thank you for the 11 more than clarifications, explicit statements.
12                  MR. BENNER:          Yes, and this is Eric 13 Benner.        Ill add some clarification, because 14 theres a lot of layers here, right?                      I think 15 everyone gets that.
16                  So that was part of our challenge as 17 the staff of, we needed to make our endorsement 18 of this process sort of standalone.
19                  So its written right now, we 20 understand that NUPIC may do some things and were 21 looking at -- theres current certifying and 22 accreditation bodies and we wanted to make sure 23 we didnt need to update the reg guide every time 24 another party added to it.
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64 1 entities.        And like Warren just said, right now 2 its constructed that since NUPIC hasnt stepped 3 in to do this role, its very clear that the licensee 4 has this responsibility.
5                  But we added our designee so that if 6 NUPIC steps in to take on this role, then its very 7 clear what NUPIC needs to do.
8                  Now, that layer is what it is.              The NRC 9 still has its independent oversight layer where 10 just like for any Appendix B or commercial grade 11 dedication activities we have, you heard Greg 12 Galletti speak.          Hes a member of our Vendor 13 Inspection and QA Branch.                They have a rubric that 14 they use to do different inspections each year.
15                  I mean, they have a certain number of 16 resources, so they pick and choose where they 17 inspect.        But just like for all commercial grade 18 dedication stuff, they go out and we do our own 19 independent look at each part of all these things 20 to draw our own regulatory conclusions.
21                  MEMBER BROWN:          So you can step in when 22 you want to?
23                  MR. BENNER:          Yes.        I mean, if we see 24 a problem, right, we always have the available to 25 step in if theres a problem.
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65 1                MEMBER BROWN:        Youre just not left out 2 --
3                MR. BENNER:          No.      I mean, the bottom 4 line is theres regulated activities so there are 5 -- our process makes it clear whose responsibility 6 it is to do those activities. And it continues to 7 make it clear that we have an independent method.
8  And those fundamentals dont change at all.
9                MEMBER BROWN:          Okay.      Thank you.      Any 10 more comments?      Go ahead.
11                MR. NACK:      Very good.          And just to 12 highlight some of the reasons why we want this 13 process and think it will be helpful is that it 14 does direct the nuclear industry to direct them 15 towards these products that can be seen as better 16 products in terms of engaging with manufacturers 17 that are particularly interested in building in 18 reliability and systematic integrity into their 19 products.
20                Because thats the result of them 21 complying with the IEC 61508 standards.                    And it 22 does provide access to a broader collection of 23 operating experiences to be used by the power 24 plants.
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66 1 commercial grade dedication on any product that 2 you wanted to and it was hard from the outside to 3 necessarily see what you were going to find before 4 you really dug into it.
5                And so, SIL certification provides a 6 helpful indicator from the outside so that you know 7 what youre getting into from the start.
8                And then with improved efficiency, you 9 are interacting with manufacturers that are able 10 to sell these products that do have the necessary 11 reliability and systematic integrity that are able 12 to sell them to other high-risk industries as I 13 mentioned earlier.
14                And it really is a benefit in terms of 15 manufacturers are already familiar with 16 interacting with people that want to dig into their 17 process and see how they do things.
18                And the process also provides 19 significant efficiencies in terms of the nuclear 20 industry not having to perform their own commercial 21 grade surveys, which are really seen as a redundant 22 activity from what the CBs were already performing.
23  And that brings us to any questions.
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67 1 it for you?
2                  MEMBER KIRCHNER:            Why dont you go 3 ahead and ask it for me?                  Because I cant quite 4 remember how I phrased it.                  You made me hold it 5 too long.
6                  MEMBER BROWN:          Im going to -- I want 7 to phrase this the right way because I think this 8 is something that the NRC as a program needs, to 9 provide about getting new stuff put into plants 10 where it ought to be.
11                  And theres a lot of resistance to doing 12 this.        Its a matter of some of the thought 13 processes.        As weve all talked about before, 14 software-based systems introduces, relative to 15 analog, introduces a whole new set of modes, 16 possible modes of failure.
17                  It can be anything from corrupt data 18 to lockups to functions not being performed because 19 you run out of time, et cetera.                      Silent stuff.
20                  As weve emphasized in most of our 21 discussions, this is my opinion in this case, not 22 the Committees opinion by any means.                      I hope it 23 is, but not.
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68 1 protection system that meets a set of requirements, 2 the redundancy and its all the standard 3 deterministic with none of our systems with 4 permanency.
5                But theyre all interrupt driven.                  At 6 least I havent found any.                And then the control 7 is physical as well as electronic access and still 8 manage to interact with the staff on it.
9                Now, thats put in place.            Watchdog 10 timers are part of the primary, almost the only 11 way that you can ensure those downstream, both the 12 processing data, processors as well as the voting 13 units if youre going to use digital components 14 for voting units, other than analog logic service.
15  Digital logic service, but not software.
16                TR whatever it is, it addresses 17 watchdog timers in considerable detail throughout 18 the supplier, particularly the concession 6.4.
19                It actually talks about an ESFAS 20 application of single unit versus a double unit, 21 which we talked about before.
22                There were a number of examples.              With 23 single units, were talking about.                And looking 24 through the IEC, there was an interest relative 25 to the single versus multi in part six, Appendix NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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69 1 B, EU.1.1, where it says, this standard 2 incorporates a number of measures which deal with 3 systematic failures.
4                However, no matter how well these 5 measures are applied, there is a residual 6 probability of systematic failures occurring.
7                Although this does not significantly 8 affect the reliability calculation, theres a lot 9 of those that goes through the IEC, for single 10 channel systems.
11                If I want to start a pump or do this, 12 the potential of failures which may affect more 13 than one channel in a multi-channel system or 14 several components in a redundant safety system, 15 paren, i.e., common cause failures, results in 16 substantial error in reliability calculations are 17 applied to multichannel or redundant systems.
18                The International Standard recognizes 19 taking a PLC with your logic and reliability and 20 dependability calculations.                It doesnt 21 necessarily transform into a multidivisional 22 system, which is what we really kind of rely on 23 in our RTS and ESFAS systems.
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70 1 the number is, 10636439, where you evaluate all 2 the equity evaluated, excuse me, the application 3 of the programmable logic control in an ESFAS 4 system, a multichannel system.
5                  And they go through an evaluation, two 6 sets of evaluations.            One, make sure I get these 7 straight, oh, yes, they evaluated the need for an 8 external watchdog timer challenge failures, and 9 it concluded that the feature wasnt required 10 because the internal diagnostics had such a high 11 degree of coverage with internal failure, the 12 implementation of watchdog onboard and watchdog 13 timers, thats in software, watchdog timers, 14 basically, is what youre talking about, is 15 sufficiently robust to protect against failure.
16                  Modes of interest with these features 17 combined with the fact that the systems are 18 functionally tested every month and theres a 19 manual backup, and therefore no watchdog timer is 20 required, hardware off guard.
21                  The example then said, well, okay, hold 22 it.        Weve also got to look at a failure analysis 23 considering the possibility of a failure that could 24 disable redundant PLCs into automatic actuation.
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71 1 that mode would be.
2                  And then they go on to say the 3 likelihood is considered very low based on a review 4 of the software development process.                  Okay, the 5 marble process.          Theyre always good.
6                  A successful operating history with the 7 controller and similar application.                  This is a 8 one-line controller.              Knowledge of the device 9 design.        And wonderful failure management 10 provisions.
11                  Monthly surveillance checks and an 12 extensive testing program performed by the vendor 13 and utility integrator to support the dedication.
14                  Okay. However, we did do a defensive 15 in-depth evaluation of that, but determined that 16 since we have operator backups, we dont need a 17 watchdog timer, which was a terrible message to 18 be sending.
19                  Theres some inconsistencies is all Im 20 saying, when you apply, just, other examples of 21 PLC that you find thats been used in a lot of 22 applications, those get software upgrades.
23                  It happens inevitably, and software 24 applications, you have to change the operating.
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72 1 frame them.
2                  They have to be compiled when theyre 3 done.        And five years later, if you use a different 4 compiler, then you use the initial design, you may 5 get a different way that code is compiled.
6                  I only make a statement like that 7 because there was one circumstance I was involved 8 in where we had a system that worked just fine but 9 we had to get a new device and put our software 10 in it.
11                  We had a different compiler and now the 12 system didnt work.              Fortunately, it wasnt an 13 operating system.            It was a testing system.
14                  So its all these things point to the 15 need for some emphasis in my thought process in 16 whats lacking, and not just my opinion, not the 17 Committees opinion, that 1.250 is a clarifying 18 position.
19                  Is it the utilization of this process 20 doesnt ever gain or put aside the need to evaluate 21 our reactive protection and safeguard systems via 22 the standard review plans, the DSRS, the Reg Guides, 23 the ISGO 6, BTP 7-19, et cetera.                      And that the 24 silent failure routine, I mean, if you go, all of 25 those documents talk about watchdog timers NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 somewhere in the architecture.
2                I would just think it would be useful 3 to have something that identifies this says this 4 parts okay but it has to be used in an integrated 5 system, particularly in multidivisional systems, 6 that we utilized skill, need to be adhered to or 7 appeal part of the process.
8                That doesnt come through as part of 9 the guidance.
10                MR. BENNER:          Yes, and Ill start, and 11 this is Eric Benner now.
12                MEMBER BROWN:          Did I pay for you all?
13                MR. BENNER:          Yes, and this is Eric 14 Benner again.        Id say we completely agree.              The 15 lens through we look at this is, the commercial 16 grade dedication process in no way, shape, or form, 17 thats what your design and licensing requirements 18 are.
19                So while the references we talked about 20 are when we actually design, an applicant designs 21 something, the license that we set certain 22 requirements and we apply all those guidance 23 standards.
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74 1 already have a design.
2                I already have components.              And now I 3 need to replace part of that with new systems or 4 components.
5                So they still have an obligation to make 6 sure that whatever theyre doing fulfills the 7 design and license requirements.                    But I see your 8 point, particularly in this situation, that 9 sometimes you believe, but this has been the case 10 for commercial grade dedication, not just in SIL 11 but across the board is, right, you want to buy 12 one thing, because that is what the design says, 13 and you buy something else and you think that 14 something else works the same exact way but it 15 doesnt.
16                Thats part of what this process is all 17 about is to say, okay, youre taking on this new 18 responsibility to get this new thing and put it 19 into your system, put it into your facility to do 20 a certain function.
21                We put a bunch of tests in place that 22 licensees and these other bodies do to convince 23 ourselves that its actually going to do what you 24 say its going to do.
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75 1 to the classic scenario, particularly as you move 2 to digital, particularly because software 3 component may be introducing failure mechanisms 4 that you havent really considered before.
5                So well certainly take that offline 6 to see what reinforcement well need.
7                MEMBER BROWN:          So hopefully Im 8 writing the report on this and Ive tried to 9 incorporate enough information in there to try to 10 get this point across.
11                The fundamental is hardware watchdog 12 timers come in a couple of different varieties.
13 A PLC could have a built-in hardware watchdog timer 14 in but just its not, its separate.
15                Theyve got to be separate.        You cant 16 depend on the operating system software.              I mean, 17 its got to be separate.              But it could have that 18 component built in but just not used in some 19 circumstances.      Or it could be an off-board one 20 thats incorporated based on your design approach.
21                So, I mean, the point being is that, 22 and I dont want to be pedantic about this, its 23 just that weve worked hard over the last 12 years.
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76 1 Im not applying it to the equivalent.
2                We didnt do it in the HIPTS process 3 because its hardware, fundamentally, and log 4 computer based by the time you program it.
5                So, I mean, we just cant lose that 6 capability or that idea.                Youve agreed that we 7 can use these and theyre okay, but they dont have 8 that.
9                Well, but this thing is not capable of 10 incorporating -- we used this in the architecture, 11 it cant incorporate it.                Thats my concern.
12                Now, Jose had a comment, I think.                    You 13 raised your hand.
14                MEMBER MARCH-LEUBA:                Yes, this concept 15 comes very often in software reliability.                        The 16 issue is open identification of requirements.
17 Before you start doing the testing, you have to 18 identify whether a watchdog timer is needed or not.
19  And its easy to forget, especially if the watchdog 20 timer is embedded into the PLC, that you need to 21 test it.
22                So I dont know if we have enough 23 emphasis.      The best way to design the software is 24 to have good requirements.
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77 1 the parts is to know what the part needs to do.
2 And thats crucial.
3                  MEMBER BROWN:          Theres always, theres 4 software timers throughout most that are 5 interrupt-driven because it stops and goes off and 6 does something.
7                  So theres a timer in the software.
8 Theres one of them every five milliseconds.                            It 9 was off doing something and it stopped everything 10 that came back and every five milliseconds it was 11 testing.
12                  It would be insane to be doing it in 13 my opinion, when I read the Topical Report, but 14 thats what they were doing.                      The system worked 15 so its in use.
16                  The point being that theres a lot of 17 little ones in there, but if the timers are part 18 of the software and the software stops, for whatever 19 reason, youre toast.                And this is the important 20 part.        Im sorry, go ahead.
21                  MR. BENNER:          And this has played out 22 significantly, not so much in these discussions, 23 but in a different realm. Applicants have looked 24 at the self-diagnostic capabilities of these 25 systems to eliminate required text message NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 analysis.
2                And weve done some of that but we also 3 basically have the same concern youve had, Member 4 Brown, of, hey, what if the self-diagnostics arent 5 working?
6                What is your mechanism to know that 7 these self-diagnostics are still working?                      And as 8 we have allowed elimination of some certain 9 balances, weve put in what we think are the right 10 checks and balances that the operator does have 11 touchpoints to ensure that those processes are 12 indeed giving you what you think theyre going to 13 give you.
14                So conceptually, weve been working 15 this issue and I think its been not so much in 16 this forum.
17                MEMBER HALNON:          And this is Greg.
18 Forgive me for being a novice.                    A component was 19 supposed to be able to do a self-diagnostic, either 20 watchdog timer or some other, wouldnt that be a 21 critical characteristic that would have to be 22 brought through the process and eventually tested 23 in some way?
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79 1 and that, and some of these safety critical devices, 2 some of these SIL requirements are that there is 3 a failure outcome, which it puts it into a safe 4 state.
5                So if it does fail, the result, its 6 essentially doing what a watchdog timer would do.
7    Essentially, put the output into a safe state 8 and so those are then become the requirements for 9 that product they are getting certified.
10                And I think one of the points that Andy 11 alluded to was that you have to, if you are going 12 to use this process, you have to see what does the 13 SIL certification mean and what feature is it 14 certifying, and for your application, are those 15 features suit your requirements or not?
16                But that assessment has to be done very 17 early in the process, before you even go and start 18 to dedicate that item for use.
19                Does it have the level of certification 20 that meets your requirements for your given 21 application?
22                So I think, and Member Brown, to your 23 point, yes, we worked on developing the SRPs and 24 the DSRS and all of these ISGs, to really shift 25 our focus toward meeting these fundamental design NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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80 1 principles for the INCs and looking at these 2 dependability of performance and repeatability and 3 dependability where we are talking about, what are 4 these lockup situations and how do we protect 5 against these things?              But that is an effort that 6 we pay a lot of attention to when we are doing the 7 overall design application.
8                  Now, here, if you are buying a part, 9 you still have to meet your overall design 10 requirements.          What are your requirements for your 11 system?        And so that requirement match has to be 12 done by the designer very early on in the process.
13                  So, I dont think we are downplaying 14 any of that effort.              I think what we are trying 15 to say, by using the SIL certified product, what 16 you are getting is actually you are getting better 17 products into your plant than you would otherwise.
18                  If you were to dedicate any commercial 19 off the shelf item that has not been proven in the 20 industry, so what we are getting from a SIL 21 certified product is a product that a manufacturer 22 is marketing to a safety critical industry.
23                  So they are saying that I have a market, 24 Im going to get this certified.                      Theyre spending 25 their effort and money in developing a product and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 getting it certified because they have a large user 2 base.
3                But what does that give us?          It gives 4 us a larger data to rely on, the reliability data 5 that we get, because we have a larger user base 6 of their product.
7                So there are these benefits that we want 8 to try to capture, and I think what we are getting 9 from that, it will not be applied properly in our 10 safety systems.        Were getting our reliability and 11 hopefully --
12                MEMBER BROWN:          I understand that 13 around the circle discussion, but when you lay out 14 requirements, youve got to do that in the context 15 of the overall system youre dealing with.
16                And youve got to address the potential 17 weaknesses of what youre dealing with.                For 18 instance, when you talk about self-diagnostics, 19 there are a couple of different ways to do that.
20  If you have a deterministic process, which I used 21 in my naval program, every function was performed 22 on every sample period, and at the end, there was 23 enough room where we implemented, we did a certain 24 amount of self-testing.
25                And then you hit the end.          Theres a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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82 1 watchdog timer there.              If it didnt get to that 2 point, okay, then it goes back to next cycle, and 3 at that last stop, it knows where it stops and you 4 go through the whole process again.
5                  Every function is tested.                No 6 interruption, all the way to the end.                    Guess whats 7 at the end again?          Another watchdog timer waiting.
8 9                  If you dont get here, Im going to give 10 you an alarm.        Or in a submarine, you may not 11 necessarily trip the reactor.                  Its not a good idea 12 to do that when youre in certain locations and 13 places.
14                  But you make people aware of it, ever 15 however you want to do it.                  Thats fairly 16 straightforward.
17                  When you do that in the testing, 18 self-testing, and its an interrupt self-testing 19 where youre 10 percent through and, oh, Ill 20 self-test this little function.                      Oh, okay, thats 21 working.        Okay, come back and I keep going.
22                  You may not ever finish.                You may lock 23 up in between.        You cant.          Theres always the 24 potential for that processor not to finish its 25 process.
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83 1                It never triggered whatever it should 2 trigger at the end to restart again.                    And the 3 problem with resetting most of these companies 4 products, like I wont mention the name, but the 5 one platform we used, it took five to ten minutes 6 to reboot.      Thats horrible.
7                MEMBER MARCH-LEUBA:                Charlie, I wonder 8 if youre confusing apples with oranges.
9                MEMBER BROWN:          Oh, probably.
10                MEMBER MARCH-LEUBA:                Yes. I mean, as 11 the staff said before, there is a step in the design 12 requirements and the range of system.                      Now you 13 raised the problem of replacing this particular 14 part in the presentation.
15                The system is really where we already 16 reviewed this.        And I want to make sure that this 17 part is as good as the whole.
18                MEMBER BROWN:          The analog one.          In 19 this case, theyre going to be replacing analog 20 stuff with digital stuff.                Thats what theyre 21 driving at, primarily.              Primarily.
22                MEMBER MARCH-LEUBA:                They have to make 23 sure that the system works.                And what I like about 24 this approach of having a large user base is that 25 databases will see the reliability of hundreds of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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84 1 systems, not two.
2                  So there is some feedback.            Maybe you 3 did your evaluation and you made a mistake.                        You 4 put hundreds of these on the field and you find 5 out you made a mistake, put some fix in there, get 6 some feedback, and you fix it.
7                  MEMBER BROWN:          Im not disagreeing 8 with using the process.              Im only looking to make 9 sure that in the process of doing this, we dont 10 distract the overall end result.
11                  The evaluations of the process we go 12 through.        The first process, you werent here, the 13 first one we looked at did not have watchdog timers 14 in it.
15                  We had to insist on it.            It was like 16 sucking blood out of rocks.                It took us a year and 17 a half to get the FSAR revised.
18                  CHAIRMAN REMPE:              So, colleagues, we 19 have four minutes left and we do have to have public 20 comments.        And I know Walt has been wanting to make 21 a comment.
22                  MEMBER BROWN:          Oh, Im sorry.
23                  CHAIRMAN REMPE:              And so I just, if 24 theres questions from staff --
25                  MEMBER BROWN:          No, Im done.
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85 1                    CHAIRMAN REMPE:            If theres time, and 2 then lets make sure theres time for public 3 comments.
4                    MEMBER BROWN:          Lets go ahead.      Yes, 5 go ahead, Walt.            Sorry.
6                    MEMBER KIRCHNER:            So I can see that the 7 main thrust here is for implementing digital 8 systems, commercial grade dedicated equipment.
9 I was just thinking ahead to advanced reactors and 10 stuff.          This is an observation, not a question.
11                    It points back here to the Reg Guide 12 Appendix B, design control, procurement control 13 and such, and advanced reactor people are basically 14 saying, Appendix A, Appendix B doesnt apply to 15 us.        Were not LWRs.        But Im just looking ahead 16 to think of new advanced reactors.
17                    Would the expectation, you think, 18 Dinesh, be you would look for them to in a comparable 19 manner go through a commercial dedication process 20 for their I&C systems?                  Its a leading question.
21                    MR. TANEJA:          Again, the advanced 22 reactors, if they have -- if they have a case where 23 there is a safety function that has to be performed 24 under certain given circumstances and conditions, 25 so for our postulated condition, if the equipment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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86 1 needs to perform that function, that component 2 needs to be qualified and proven that its reliable 3 from that function.
4                Now, if you want to call it an Appendix 5 B or you want to call it a dedicated item, or you 6 want to call it whatever you want to call it, on 7 that new FSAR 53 framework or MP framework, at the 8 end of the day, I need to have a system or a device 9 or a system that reliably performs that function 10 repeatedly if it's required, right?
11                And I think that is a discussion that 12 we had a couple of the new vendors was that its 13 really upon you to demonstrate that you are 14 designing this system with high reliability and 15 availability.
16                And that reliability, how do you 17 demonstrate that?          Now, some are saying that we 18 are going to follow the IEC 61503 framework, which 19 actually has done pretty good with the risk 20 significant industries otherwise.
21                So well see what they come back with.
22                CHAIRMAN REMPE:            Charlie, do you want 23 to be the person to ask for public or you want me 24 to?
25                MEMBER BROWN:          No, you can do it.
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87 1                CHAIRMAN REMPE:              Oh, okay. So were 2 at that time where if someone, a member of the public 3 is out there, if you are on MS Teams, just unmute 4 yourself and make a comment.
5                If youre on the phone line, I believe 6 you have to press star-six to unmute yourself.
7 But, feel free to do so.
8                (No response.)
9                CHAIRMAN REMPE:            Okay, theres been 10 ten seconds so at this point -- yes, Charlie?
11                MEMBER BROWN:          You answered the 12 question.
13                CHAIRMAN REMPE:              Okay. Go ahead.
14                MEMBER BROWN:          Im sorry. No, I just 15 wanted to thank the staff at NEI for a very good 16 summary download from the last Subcommittee meeting 17 where there was a little more detail.                But I think 18 this was a substantial presentation.                  We got to 19 get to the meat of the overall process and what 20 youre trying to accomplish.
21                And I thought it was done very well and 22 the discussion was animated, as I would have 23 expected in our normal format with these I&C 24 discussions.        I just thought it was a good talk.
25                CHAIRMAN REMPE:              I agree.
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88 1                MEMBER BROWN:          Thank you.
2                CHAIRMAN REMPE:            I believe you have 3 a draft letter that you plan to read in in the next 4 hour and we can discuss it and continue the 5 discussions that you and Jose and Walt were having.
6                Larry, if youre off, or Christina, if 7 youre out there, we need to get hold of Sandra 8 and whoevers going to be helping us with the letter 9 and get it brought up.            And so, why dont we take 10 a break until 3:40?          And thatll give us nine 11 minutes to try and find the appropriate people.
12                MEMBER BROWN:          What about 15 minutes?
13                CHAIRMAN REMPE:            Okay, Charlie, just 14 for you, how about 3:45?              Were going to do 3:45.
15  You get 14 minutes.          Get a head start.          And I 16 hope that NEI and the staff will stay around and 17 listen to the letter.            And, as always, we want 18 factual corrections and --
19                MEMBER BROWN:          No, its not going to 20 happen.
21                CHAIRMAN REMPE:            Charlie drafted the 22 letter, so Im sure its factually true.                  But 23 anyway, well see what happens.
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89 1 the --
2                CHAIRMAN REMPE:            At this point, 3 though were going to give you your 14 minutes 4 before they turn to 13.
5                (Whereupon, the above-entitled matter 6 went off the record at 3:32 p.m.)
7 8
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NEI 17-06, Rev. 1 Overview 7 September 2022- ACRS Meeting
  ©2022 Nuclear Energy Institute
 
NEI 17-06 Rev. 1 Issued 12/3/2021 (ML21337A380)
The purpose of this document is to facilitate the commercial grade dedication process for digital equipment by crediting SIL certification by an accredited and NRC-approved certification body https://www.nrc.gov/docs/ML2133/ML21337A380.pdf  in lieu of a commercial grade survey and critical design review
                                                                      ©2022 Nuclear Energy Institute 2
 
Safety Integrity Level (SIL) Overview SIL Foundation
* Systematic Integrity LOGIC
* Probabilistic Reliability        SOLVER
* Hardware Fault Tolerance SENSOR      ON/OFF ACTUATION
                                                ©2022 Nuclear Energy Institute 3
 
SIL Certification Process Accreditation Body Accreditation Certification Body ISO 17065 Evaluation Service OEM IEC 61508
                                      ©2022 Nuclear Energy Institute 4
 
Conclusion from EPRI Research Safety Integrity Level (SIL) Certification Efficacy for Nuclear Power. EPRI, Palo Alto, CA: 2019. 3002011817.
* SIL certification aligns well with EPRI TR-106439
* Certification Bodies (CBs) have a standardized, rigorous, and reliable evaluation process
* Accreditation Bodies (ABs) ensure CBs are consistent and trustworthy
* Failure data indicates reliable operation of SIL certified equipment
* SIL certifications are an accurate indicator of reliability
                                                                                                  ©2022 Nuclear Energy Institute 5
 
Justification Process- Current EQUIPMENT QUALIFICATION  COMMERCIAL GRADE DEDICATION
                                          ©2022 Nuclear Energy Institute 6
 
Justification Process- with NEI 17-06 EQUIPMENT QUALIFICATION    COMMERCIAL GRADE DEDICATION IEC 61508 SIL Certification IEC 61508 SIL Certification
                                              ©2022 Nuclear Energy Institute 7
 
Application of the SIL Certification Process Step 1. Identify the requirements of the end users application Step 2. Confirm SIL certification encompasses the requirements of the application Appendix B QA Program
                                                          ©2022 Nuclear Energy Institute 8
 
Application of the SIL Certification Process Step 3. Perform a technical evaluation of the equipment to identify critical characteristics Step 4. Perform a technical evaluation of the CBs service to identify the critical characteristics of the service Appendix B QA Program
                                                          ©2022 Nuclear Energy Institute 9
 
Application of the SIL Certification Process Step 5. Confirm that IEC 61508 certifications are within the CBs accreditation scope Step 6. Complete the CGD of the CBs service Appendix B QA Program
                                                          ©2022 Nuclear Energy Institute 10
 
Application of the SIL Certification Process Step 7. Use the SIL certification to complete the determination of acceptability of the dependability CCs of the item CGD Step 8. Use traditional methods to determine acceptability of the physical and performance CCs Appendix B QA Program
                                                          ©2022 Nuclear Energy Institute 11
 
Selection of SIL Certified Equipment
* The equipment must be able to perform the required functions for the application
* Equipment must be certified to IEC 61508 at the required level
* The required safety function must be within the scope of the safety function identified in the certification
                                                                ©2022 Nuclear Energy Institute 12
 
Paths to Accepting Certification Body (CB) Services
* Accreditation Only
* Accreditation Body observed conducting a satisfactory ISO 17065 assessment of the Certification Body
* Accreditation Plus Scheme Evaluation
* Accreditation Body observed conducting a mostly satisfactory ISO 17065 assessment of the Certification Body
* Additional assessment performed of the Certification Bodys certification scheme
                                                    ©2022 Nuclear Energy Institute 13
 
Dedicating Entitys Quality Assurance Program Adjustments will be needed to Appendix B QA programs concerning:
* Procurement Document Control
* Tasks Associated with Digital Dependability Evidence
* QA Evidence for Digital Dependability
* Corrective Action
                                                      ©2022 Nuclear Energy Institute 14
 
US NRC Licensee Oversight of the SIL Certification Process Possibly an entity      Oversight by US NRC such as NUPIC            Licensee or Accreditation Body Designee Accreditation Appendix B        Dedicating Entity      Certificate of QA Program Accreditation CGD of Service                              Certification Body ISO 17065 CGD of Equipment/
Components SIL Certificate
                - Dependability CCs                            Evaluation Service
                -Performance CCs
                    -Physical CCs Equipment/
Components          OEM and        IEC 61508 Safety Manual
                                                                                  ©2022 Nuclear Energy Institute 15
 
Benefits
* Better Products
* Manufacturers are building in reliability and systematic integrity
* Broader collection of operating experience
* Improved Efficiency
* Economy of scale- joining other high-risk industries to give manufacturers a larger market to sell into
* Products are pre-approved by CBs, not requiring commercial grade surveys
                                                          ©2022 Nuclear Energy Institute 16
 
Questions
          ©2022 Nuclear Energy Institute 17
 
Draft Regulatory Guide DG-1402 Proposed new RG 1.250 Dedication of Commercial-Grade Digital I&C Items for Use in Nuclear Power Plants September 7, 2022 ACRS Committee Meeting 1
 
Opening Remarks Eric Benner, Director Division of Engineering
  & External Hazards Office of Nuclear Reactor Regulation 2
 
DG-1402 Working Group Dinesh Taneja, Technical Lead Sr Electronics Engineer, NRR/DEX/ELTB
* Michael Eudy - Project Manager, RES/DE/RGPMB
* Bernard Dittman - Sr I&C Engineer (Retired), RES/DE/ICEEB
* David Rahn - Sr Electronics Engineer, NRR/DEX/ELTB
* Greg Galletti - Sr Rx Ops Engineer, NRR/DRO/IQVB
* Odunayo Ayegbusi - Rx Ops Engineer, NRR/DRO/IQVB
* Jack Zhao - Sr Electronics Engineer, NRR/DEX/ELTB
* Jonathan Ortega-Luciano - (Former) Rx Ops Engineer, NRR/DRO/IQVB 3
 
Meeting Topics
* DG-1402 Scope & Purpose
 
==Background:==
 
  - CGD of digital equipment
  - DI&C Modernization Project (MP) #3
  - Development of NEI 17-06
* DG-1402 Regulatory Basis
* DG-1402 NRC Staff Regulatory Guidance
* Resolution of Public Comments on DG-1402
* Historical Perspectives of CGD 4
 
DG-1402 Scope & Purpose
* Endorse NEI 17-06, Revision 1
* Endorse applicable parts of the industry consensus Std. IEC 61508, 2.0 Edition
* Endorse applicable parts of the industry consensus Std. ISO/IEC 17065:2012
* Describe relationships with existing endorsed CGD guidance documents RG 1.164 and EPRI TR-106439 5
 
DG-1402
 
===Background===
* EPRI TR-106439 describes an approach for the evaluation and acceptance of commercial-grade digital equipment
* RG 1.164 describes acceptable methods for the dedication of commercial-grade items and services.
* In April 2016 NEI proposed a task under DI&C Integrated Action Plan (IAP) to leverage SIL certification to IEC 61508 in commercial-grade dedication of digital equipment
* Proposed guidance to follow the NRC approved NEI 14-05 process for procuring commercial-grade laboratory calibration and test services 6
 
DG-1402
 
===Background===
(continued)
* In parallel, EPRI initiated a research on SIL certification of digital equipment used in non-nuclear process industry and produced report EPRI 3002011817, Safety Integrity Level (SIL)
Certification Efficacy for Nuclear Power
* As a part of MP #3 task, NEI initiated developing NEI 17-06 guidance informed by the EPRI research
* The NRC staff provided continual feedback during NEI 17-06 development
* On multiple occasions, the staff observed audits of certifying body (exida, LLC) by the accrediting body (ANAB)
* After resolution of NRC staff comments, NEI 17-06, Rev. 1 was submitted in Dec-2021 for NRC endorsement 7
 
DG-1402 Regulatory Basis
* 10 CFR 21.3 defines basic component as, among other things, commercial grade items which have successfully completed the dedication process and provides definitions for commercial grade item and dedication
* 10 CFR Part 50, Appendix B, Criterion III, Design Control and Criterion VII, Control of Purchased Material, Equipment, and Services, includes provisions for QA and quality control that are applicable to the acceptance and dedication process for commercial-grade digital I&C items 8
 
DG-1402 Staff Regulatory Guidance Position 1
: 1. DG-1402 endorses, with clarifications, NEI 17-06, Revision 1, on using IEC 61508 SIL certification to support the acceptance of commercial-grade digital equipment that is dedicated as a basic component in accordance with EPRI TR-106439 9
 
DG-1402 Staff Regulatory Guidance Position 1 clarifications
: a. The NRC staff considers SIL certification to be a commercial grade survey for the purposes of Part 21. Thus, considers dedication of the certifying bodys services and verification of SIL certification to be adequate for verifying dependability critical characteristics
: b. Each dedicating entity should dedicate the services of each certifying body and should not rely on dedication by, e.g., another NRC licensee 10
 
DG-1402 Staff Regulatory Guidance Position 1 clarifications (continued)
: c. In keeping with NRC staff-accepted practices, the certifying bodies SIL certification process should be observed every 3 years
: d. In accordance with 10 CFR 21.3, the NRC use of the term basic component includes dedicated commercial grade items
: e. Dedicating entities should take measures to avoid the acceptance of expired, counterfeit or fraudulent SIL certificates 11
 
DG-1402 Staff Regulatory Guidance Position 2 with clarifications
: 2. DG-1402 endorses, with clarifications, use of IEC 61508, Edition 2.0 as described in NEI 17-06
: a. Dedicating entities should verify the certifying bodys accreditation consistent with the guidance in section 6.3 of NEI 17-06
: b. Dedicating entities should verify that the substantive requirements of the later editions related to the dependability characteristics remain unchanged from the IEC 61508, Edition 2.0                                                                12
 
DG-1402 Staff Regulatory Guidance Position 3
: 3. DG-1402 endorses the use of ISO/IEC 17065:2012 by certifying bodies to perform commercial grade surveys as described in NEI 17-06 13
 
The NRC received 5 public comments on DG-1402 that have been adequately resolved
: 1. In response to comment 1, clarification has been added to Staff Position 1.b. that partly states, each Resolution    of the licensees or dedicating entities relying on the results of a commercial grade dedication performed of Public    on behalf of licensees or dedicating entities remains individually responsible for the adequacy of the Comments      commercial grade dedication.
: 2. In response to comment 2, Section B of DG-1402 has been revised to state, NEI 17-06 leverages an internationally recognized safety integrity level (SIL) certification process that relies on International Electrotechnical Commission (IEC) 61508, 14
: 3. NRC staff agrees with comment 3 and the recommended edit has been made to Section B of DG-1402, The NRC staff considers SIL certification to be a commercial grade survey for the purposes of Part 21.
Resolution  4. NRC staff agrees with comment 4, but not of Public      entirely with the recommended edits. Staff Position 2.a. has been edited to clearly indicate Comments        that NEI 17-06 is leveraging an existing certifying bodies accrediting process.
(continued)
: 5. NRC staff disagrees with the comment 5 recommendation of a reduced frequency for observing certifying bodies certification process. Therefore, no changes were made to DG-1402 as a result of this comment.
15
 
CGD of Items & Services Historical Perspectives 1970s              1976                1978                1988                  1989 CGI                Industry            10 CFR 21            EPRI NP-5652          GL 89-02 Procuremen          Standard tIn Mid 1970s, more First standard to  October 1978        In June 1988, EPRI    In March 1989, the attention given to address commercial  revision to 10CFR21  issued NP-5652 to      NRC issued GL 89-CGI procurement    off-the-shelf items required a          address the need for  02 that conditionally practices due to  was ANSI N18.7-    commercial-grade    a methodology that    endorsed EPRI NP-lack of suppliers  1976, which is      item to be dedicated ensures CGIs are      5652 with App. B QA    endorsed by the NRC before it could be  dedicated in programs          in RG 1.33          used as a basic      accordance with component            10CFR21 DG-1402 (Proposed new RG 1.250) 1 6
September 7, 2022
 
CGD of Items & Services Historical Perspectives 1991                1994                1996              1997                  2011 GL 91-05            EPRI TR-            EPRI TR-          NRC Staffs SE        SECY                      102260              106439                                    0135 In April 1991, GL  In March 1994, EPRI In October 1996,  In July 1997, the      In September 2011, 91-05 was issued to TR-102260 was      EPRI TR-106439 was NRC staff issued a    staff issued SECY-apply existing      issued to provide  issued to provide  safety evaluation to  11-0135 to indicate regulatory          supplemental        guidance on        endorse EPRI TR-      importance of requirements in 10  guidance for        acceptance of      106439                developing RGs for CFR 50, App. B to  application of EPRI commercial-grade                          CGD activities CGD process        NP-5652            digital equipment DG-1402 (Proposed new RG 1.250) 1 7
September 7, 2022
 
CGD of Items & Services Historical Perspectives 2014              2016                  2017                  2021                    2022 EPRI              MP #3                RG 1.164              NEI 17-06              DG-1402 3002002982 In September 2014, In April 2016, a task In June 2017, RG      In December 2021,      In 2022, DG-1402 ERPI issued Rev. 1 was proposed under    1.164 was issued that NEI 17-06, Rev. 1,      (proposed new RG to NP-5652 and TR- DI&C IAP to          endorses EPRI        prepared under MP      1.250) is being 102260 as EPRI    leverage SIL          3002002982 with      #3, was submitted for  developed for 3002002982.        certification to IEC  exceptions or        NRC endorsement        endorsing NEI 17-Section 14.1      61508 in CGD of      clarifications                                06, Rev. 1 references EPRI    digital equipment TR-106439 DG-1402 (Proposed new RG 1.250) 1 8
September 7, 2022
 
Questions 19}}

Latest revision as of 03:12, 16 November 2024

Transcript of the Advisory Committee on Reactor Safeguards 698th Full Committee Meeting, September 7, 2022, Pages 1-127 (Open)
ML22278A065
Person / Time
Issue date: 09/07/2022
From:
Advisory Committee on Reactor Safeguards
To:
Burkhart, L., Antonescu, C., ACRS
References
NRC-2076
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