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[ Briefing Slides ]
1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 OFFICE OF THE SECRETARY 4 *** 5 BRIEFING ON THE FINAL RULE -- PART 70 6 REGULATING FUEL CYCLE FACILITIES 7 *** 8 PUBLIC MEETING 9 10 Nuclear Regulatory Commission 11 One White Flint North 12 11555 Rockville Pike 13 Rockville, Maryland 14 Tuesday, June 20, 2000 15 16 The Commission met in open session, pursuant to 17 notice, at 9:30 a.m., the Honorable RICHARD A. MESERVE, 18 Chairman of the Commission, presiding. 19 COMMISSIONERS PRESENT: 20 RICHARD A. MESERVE, Chairman of the Commission 21 GRETA J. DICUS, Member of the Commission 22 NILS J. DIAZ, Member of the Commission 23 EDWARD McGAFFIGAN, JR., Member of the Commission 24 JEFFREY S. MERRIFIELD, Member of the Commission 25 2 1 STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE: 2 ANNETTE L. VIETTI-COOK, Secretary 3 KAREN D. CYR, General Counsel 4 JACK ALLEN, WESTINGHOUSE COMMERCIAL NUCLEAR FUEL DIVISION 5 MARVIN FERTEL, NUCLEAR INFRASTRUCTURE SUPPORT & INTERNATIONAL PROGRAMS 6 CHARLES VAUGHAN, GLOBAL NUCLEAR FUEL 7 HEATHER ASTWOOD, NRC 8 DREW PERSINKO, NRC 9 MICHAEL WEBER, NRC 10 WILLIAM TRAVERS, EDO 11 CARL PAPERIELLO, NRC 12 MARTIN VIRGILIO, NRC 13 14 15 16 17 18 19 20 21 22 23 24 25 3 1 P R O C E E D I N G S 2 [9:30 a.m.] 3 CHAIRMAN MESERVE: Good morning. The Commission 4 is meeting this morning to hear from the Office of Nuclear 5 Materials Safety and Safeguards and the Nuclear Energy 6 Institute on the staff's draft final rule for amending 10 7 CFR Part 70. 8 This, of course, is the part of our regulation 9 that deals with the licensing of facilities that handle 10 greater than a critical mass of special nuclear material. 11 I am particularly pleased to be able to 12 participate in this, in that this is yet another of the 13 Commission's activities of which I'm the beneficiary of the 14 hard work of my colleagues in the past. This is an example, 15 I think, of an area in which very significant efforts have 16 been by both the staff and my colleagues to go to a more 17 risk-informed and performance-based approach to regulation. 18 As I understand it, this is also an area in which 19 there has been extensive work with stakeholders, which has, 20 I think, as I understand it, served to significantly reduce 21 the controversies associated with this proposal. So a very 22 pleasing story, I think. 23 Why don't we proceed. Let me turn to my 24 colleagues, first, however, to see if they'd like to make an 25 opening statement. If not, Dr. Travers, you may proceed. 4 1 MR. TRAVERS: Thank you, Mr. Chairman. We are 2 here to discuss with you our proposed final rule for Part 70 3 and, as you mentioned, there has been quite a lot of hard 4 work by the staff and quite a high degree of participation 5 by our stakeholders in this developing rule. 6 In fact, there is additional work that we will 7 tell you about that deals with continuing efforts to develop 8 the standard review plan and some of the guidance associated 9 with implementation of that rule. 10 So why don't we get underway? Let me introduce, 11 very quickly, Carl Paperiello, of course, is my deputy for 12 materials research and state programs; Marty Virgilio, who 13 is the deputy office director in NMSS. 14 Of course, Mike Weber is the director of the 15 Division of Fuel Cycle Safety and Safeguards, and Heather 16 Astwood and Drew Persinko, who are also from the Division of 17 Fuel Cycle Safety and Safeguards. 18 With that, let me turn over the briefing to Drew 19 and Heather, who will be giving the principal part of the 20 briefing. 21 MS. ASTWOOD: Thank you. Good morning. I will be 22 giving the first part of the presentation and then I will 23 turn it over to Drew. 24 If you'd turn to your first slide, this contains 25 an overview of the briefing that we will present today. We 5 1 plan to discuss the draft final rulemaking that's before the 2 Commission currently, the issues that have arisen during 3 this rulemaking process, both on the rule and the SRP, and 4 to go over our plans for the future. 5 Next slide, please. This rule is a significant 6 element in making the materials regulation program more 7 risk-informed and performance-based. It is consistent with 8 the performance goals of the strategic plan. It maintains 9 safety in that it requires an integrated look at safety and 10 maintenance of the safety basis once it's established. 11 It increases the public confidence, because it 12 requires facilities to do an integrated safety analysis and 13 identify and maintain those items it identifies as most 14 important to safety. 15 This rule was also developed in a very open public 16 process, which began in 1993, and has allowed ample 17 opportunity for public comment. 18 It increases the effectiveness and efficiency of 19 the NRC regulatory programs in that it establishes objective 20 performance goals or performance objectives and it focuses 21 on the areas of most risk. 22 It reduces unnecessary regulatory burden, in that 23 it has a provision in it that allows licensees to make 24 changes to their facility without NRC prior approval. It 25 also reduces the burden associated with reporting 6 1 requirements, in that it replaces Bulletin 9101 for 2 criticality reporting, and it allows licensees to grade 3 controls at their facility commensurate with their risk 4 importance. 5 Next slide. A very brief history of this 6 rulemaking. I think everybody is very aware of the history 7 here. The need for this rulemaking was realized through the 8 operating experience of fuel cycle facilities. The 1986 9 even at Sequoyah Fuels, as shown in this picture, this is a 10 picture of the actual rupture, UF-6 cylinder, in addition to 11 the 1991 GE incident, as well as other incidents at other 12 facilities in the past, initiated a comprehensive review of 13 the fuel cycle safety program. 14 This review identified some weaknesses and areas 15 that needed to be improved in this program. 16 Therefore, in 1991, the staff began trying to 17 increase its knowledge of the safety areas of facilities. 18 They developed the Bulletin 9101 to be aware of criticality 19 events and began initiating this or considering initiating 20 this rulemaking activity. 21 The industry also recognized the need for this 22 rulemaking and submitted a petition for rulemaking in 1996. 23 Next slide. After reviewing the proposed 24 rulemaking package that the staff submitted in June of 1999, 25 the Commission issued an SRM approving the proposed rule for 7 1 public comment and directing the staff to pay particular 2 attention to some specific issues when doing their final 3 rulemaking package. 4 I'm going to briefly touch on some of those 5 issues. Drew will follow up in more detail when he talks 6 about the major rule issues in his presentation. 7 One of the issues asked to consider was backfit. 8 In the SRM, the Commission stated that backfit should be 9 deferred, the implementation of backfit should be deferred 10 until staff has adequate experience and a safety basis for 11 the facilities has been established. 12 They also asked us to go to the stakeholders and 13 ask for input on how long that implementation delay should 14 be. We did do that. We asked for comments. The comments 15 we received indicated that stakeholders wished that the 16 backfit to provision B implemented immediately effective. 17 We did include the backfit provision in the rule 18 based on the comments. It's very similar to the current 19 regulations in 76.76 for gaseous diffusion plants and 5109 20 for the reactor facilities. It has one small difference in 21 that it does not contain the word "substantial."" It's 22 based on a December 1998 SRM. The Commission stated "The 23 Commission supports the requirement that any new backfit 24 pass a cost-benefit test without the substantial increase in 25 safety test. The Commission believes that modest increase 8 1 in safety at minimal or inconsequential costs could be 2 justified on a cost-benefit basis."" Therefore, we left 3 that out of the final rulemaking package. 4 The Commission also asked the staff to make sure 5 that the definition of unlikely and probably are clearly 6 defined. The staff did do this. We added words to the SRP 7 in both chapter 3 and 11 to make sure these words were 8 clearly defined. 9 I skipped reporting frequency. Excuse me. The 10 Commission directed the staff to reconsider the reporting 11 frequencies for the changes made by the licensee under the 12 change control process. 13 We did reconsider those frequencies. We went back 14 and looked at our reasons for having those frequencies in 15 the first place and we did change them, we feel, to be 16 generally consistent with the change process for the 17 reactors, yet still maintain the safety information that we 18 require, and Drew will explain that more in detail in his 19 presentation. 20 The Commission also directed the staff to ensure 21 that the SRP continues to clearly acknowledge that all 22 licensees can use approaches that are different than what 23 are currently in the SRP. We added more language to the SRP 24 to make sure that it is clear to everybody who uses it, both 25 the NRC reviewers and the licensees, that other alternative 9 1 approaches can be used. 2 And, finally, the Commission directed the staff to 3 consider using public workshops and meetings in order to 4 discuss rule comments and issues. Staff feels that we have 5 continued the extensive stakeholder interactions that were 6 started in 1993 for the Part 70 rulemaking. We have had 7 numerous interactions since the proposed rulemaking was 8 issued. We've had four public meetings where we discussed 9 rule issues, SRP issues, public comments, and several 10 example documents that both industry and staff developed. 11 We have also addressed numerous written comments 12 and maintained an extensive SRP web site -- I mean, Part 70 13 web site. 14 That concludes my introduction to the presentation 15 and I will now turn it over to Drew Persinko. 16 MR. PERSINKO: Good morning. 17 CHAIRMAN MESERVE: Good morning. 18 MR. PERSINKO: We have received numerous comments 19 on both the rule and the associated guidance documents in 20 the process of this rulemaking. The public comments raised 21 general issues concerning the rule and the guidance 22 documents. 23 For each comment, staff has carefully considered 24 the comment, evaluated alternative approaches that could 25 resolve the comment, and recommended the approach that it 10 1 thought best addressed the comment. 2 The following are the major issues raised by the 3 public comments. The first is backfit. As Heather stated, 4 the final rule incorporates a backfit provision similar to 5 the 5109 provision and the 76.76 provision. Under the final 6 rule, licensees are expected to assess the safety of the 7 facility in an integrated fashion and establish a new safety 8 baseline with respect to the performance requirements of the 9 rule. 10 However, there are facility requirements for which 11 a baseline is adequately established and for which the staff 12 does have experience and they are not affected by this 13 rulemaking; for example, Part 20 requirements. 14 For these areas, the backfit requirements apply 15 after the staff publishes its guidance document, which we 16 expect to be approximately six months from now. 17 For those areas where there is not a defined 18 baseline and for which the staff does not have much 19 experience, meaning specifically the subpart (h) 20 requirements of the new rule, the backfit provision would 21 apply after the staff approves the ISA summary submitted by 22 the licensee, which establishes the safety baseline. 23 We have discussed this position with the committee 24 to review generic requirements, the CRGR, and the CRGR 25 supports this position. 11 1 If issues arise between now and when the backfit 2 provision becomes effective, technical staff and management 3 will continue the process it has in the past. Currently, 4 both staff and management review all safety issues raised 5 and any concerns are elevated to higher levels of 6 management. Historically, staff and management have 7 successfully dealt with safety decisions to this consistent 8 structured decision-making process. 9 The next issue where public comments were received 10 was reporting frequency for the ISA summary updates. The 11 Commission, in an SRM, directed the staff to reconsider the 12 reporting frequencies for the ISA summary updates. 13 Specifically, the Commission said that absent a compelling 14 reason that the change -- the updating frequency should be 15 changed to annually to be consistent with the reactor 16 regulatory program. 17 We revised the rule to be what we believe to be 18 consistent with the reactor regulatory program. We've 19 relaxed the reporting requirements to annually for all ISA 20 summary information, except those that relate to the items 21 relied on for safety. 22 However, for the changes to the descriptive list 23 of the items relied on for safety, the final rule still 24 requires that these changes to this list be reported 25 quarterly. 12 1 Staff believes that reporting this information 2 quarterly is important for three reasons. First, the items 3 relied on for safety and their function most directly affect 4 the risk of the facility. Second, it allows the licensees 5 and the staff to have a common knowledge -- common 6 understanding that is relatively up-to-date of what is being 7 relied on to maintain the safe operation of the facility. 8 And, third, it allows the staff to review 9 important changes to the items relied on for safety on a 10 relatively timely basis. This is important because if an 11 analysis is performed incorrectly, the staff would see the 12 results of that analysis within three months afterward and 13 could question the licensee if it has safety concerns. 14 The staff position is based on an analogy that the 15 items relied on for safety are equivalent to reactor 16 technical specifications and that both the items relied on 17 for safety and the technical specifications define the 18 safety envelope of the facility. 19 Reactor plants have both Q lists and technical 20 specifications. However, it is the tech specs, not the 21 equipment on the Q list, that establish the safety envelope 22 of the facility. 23 The rule for the fuel cycle facilities requires 24 identification of each of the items relied on for safety and 25 a description of their function in sufficient detail for the 13 1 staff to understand how the performance requirements are 2 met. The staff -- excuse me. It's a descriptive list, it's 3 not merely a list of components, and the staff considers 4 that the descriptive list of the items to be equivalent to 5 the information contained in tech specs, because both the 6 descriptive list of items relied on for safety and the 7 technical specifications contain identification of equipment 8 or systems and their functional requirements. 9 Actually, if you accept the analogy, the quarterly updates 10 are less restrictive than the tech specs, since the tech 11 specs require pre-approval by the staff before implementing 12 the change. 13 The next area where comments were received has to 14 do with the level of detail in the ISA summary. Actually, 15 few rule comments were received in this area. Most of the 16 comments were SRP comments. 17 Staff considers the ISA summary to be the primary 18 licensing document by which the staff uses to determine with 19 reasonable assurance whether the performance requirements 20 are met. The rule requires nine types of information in the 21 ISA summary; for example, the descriptive list of the items 22 relied on for safety, information to demonstrate compliance 23 with the performance requirements, process descriptions, 24 things of that nature. 25 By approving the ISA summary, it establishes the 14 1 licensing baseline which is beneficial for both licensees 2 and the staff. This one-time initial approval brings 3 closure to the issues through the licensing process and 4 gives a consistent baseline upon which to conduct 5 inspections and apply the change process and the backfit 6 provision. 7 The proposed rule did not specifically call out 8 that the ISA summary would be approved by the staff, but it 9 was called out in the statements of consideration. Staff 10 always intended that the ISA summary would be approved, so 11 the staff revised the rule language to be consistent with 12 the statements of consideration. 13 Also, regarding the ISA summary, the Nuclear 14 Energy Institute and the industry are developing a guidance 15 document to complement the standard review plan. Staff is 16 working with NEI in developing that document and a meeting 17 is tentatively being arranged for late July to continue to 18 work on the document. 19 The next area relates to the failure log for the 20 items relied on for safety. The proposed rule contained a 21 provision that a log be maintained which documents failures 22 of items relied on for safety. That provision is no longer 23 in the final rule. 24 Based on the comments we received, staff believed 25 that this information was being recorded by licensees. So 15 1 we changed the final rule to require that this information 2 be readily retrievable for NRC inspections, but it no longer 3 has to be maintained in a separate document. 4 Comments were also received on the time period for 5 completion of the ISA. Comments received requested more 6 time than the four years. 7 The staff reviewed the comments and felt that the 8 four years to perform the ISA and implement the resulting 9 modifications was sufficient. 10 However, we did add words to the final rule which 11 provided for an extension of time for circumstances which 12 may be beyond the licensee's control. 13 Next slide, please. The next slide is on the 14 standard review plan. 15 With respect to the standard review plan, based on 16 comments we received at stakeholder meetings, there appears 17 to be general support by stakeholders on the standard review 18 plan, except for areas in two chapters, chapter 3, the ISA, 19 and chapter 11, the management measures. 20 Regarding the comments on the ISA, they appear to 21 be -- there appears to be concern about the level of detail 22 in the ISA summary. This was discussed at a June 8 meeting 23 with stakeholders. At that meeting, the industry presented 24 a document that it's working on, the ISA summary guidance 25 document. 16 1 The document is a work in progress. It was not 2 complete at the time of that meeting. But based on what the 3 staff saw at that meeting, the staff felt that the document 4 was clear, it was well written, it was complementary to the 5 standard review plan, and that some further clarification 6 was needed, however, and the staff intends to provide 7 written comments to the industry on this document and plans 8 to work with the industry further on this. 9 Other comments on the ISA summary had to do with 10 the methodology, the ISA methodology. There appears to be 11 some concern about the methodology to be used, specifically 12 whether the use of a quantitative probabilistic risk 13 analysis assessment is necessary. 14 Staff's NUREG on the ISA allows different methods 15 to be used. One of the methods is a quantitative PRA, 16 however. But the SRP specifically states, "An applicant may 17 use quantitative methods and definitions for evaluating 18 compliance with 10 CFR 70.61, but nothing in the SRP should 19 be construed as an interpretation that such methods are 20 required."" 21 So the standard review plan allows flexibility in 22 the methodology to be employed. 23 With respect to the management measures, chapter 24 11, again, it appears to be a level of detail question. 25 Again, on June 8, this issue was discussed at the June 8 17 1 meeting. An example was discussed and it appeared to be 2 generally well received by the stakeholders. 3 Staff plans to revise the chapter 11 and chapter 4 3, as appropriate, publish the document on the web, obtain 5 comments, and then revise the document based on the comments 6 received. 7 As mentioned, staff plans to have follow-up 8 stakeholder meetings on these two chapters in July to work 9 on closing the SRP issues. However, staff believes that 10 there is no need to delay approval of the rule pending the 11 conclusion of that meeting. 12 Next slide, please. Future actions planned by the 13 staff. If approved by the Commission, the rule will become 14 effective 30 days after publication. Within six months 15 after publication, licensees would submit their ISA plan to 16 the NRC and, about the same time, staff would also publish 17 its backfit guidance. 18 After the guidance is published, the backfit 19 provision would become effective to the non-subpart (h) 20 requirements on the facility. Approximately one year after 21 the publication, the staff plans to complete its remaining 22 guidance documents, with stakeholder involvement, and those 23 documents are the ISA summary, in conjunction with the 24 industry prepared document, reporting requirements, and the 25 change process. 18 1 Then four years after publication of the rule, 2 licensees would be required to complete their ISA, fix any 3 unacceptable deficiencies and submit an ISA summary to the 4 NRC. 5 It's important to point out that revisions to the 6 fuel cycle oversight process are planned in parallel with 7 the implementation of the final rule. As the Commission is 8 aware, progress has been made in this area with stakeholders 9 and the next workshop will convene in September. 10 We plan to pilot test revised inspections next 11 fiscal year and the inspection plans will incorporate 12 revisions to reflect ISAs, items relied on for safety, and 13 management measures, as appropriate. 14 It's also important to note that the application 15 for the mixed oxide fuel fabrication facility, the MOX 16 facility, which is expected by the end of the calendar year, 17 will also use the new Part 70 rule requirements in its 18 application. Staff plans to finalize the MOX standard 19 review plan following the Commission decision on the Part 70 20 rulemaking. 21 Next slide, please. In conclusion, staff believes 22 that in the development of the final rule, with the benefit 23 of extensive stakeholder interactions, that we have adequate 24 addressed all the major issues raised by stakeholders 25 concerning the rule and the standard review plan and is 19 1 consistent with the Commission's performance goals. 2 Staff recommends that the rule be approved and 3 placed into effect. Approving the rule would provide 4 stability and would aid the staff and the industry in 5 finalizing guidance documents, the ones that are being 6 developed by the industry, as well as the standard review 7 plan that the staff is currently working on. 8 Staff will continue to work with stakeholders on 9 these issues. That concludes my presentation. 10 MR. TRAVERS: And that concludes our presentation 11 this morning, Mr. Chairman. 12 CHAIRMAN MESERVE: Thank you very much for a 13 helpful presentation. Let me turn to my colleagues for 14 questions. Commissioner Merrifield. 15 COMMISSIONER MERRIFIELD: Thank you, Mr. Chairman. 16 I guess the first question I have to the staff goes back to 17 the ISA and the issue of the quarterly -- actually, I'm 18 sorry, the first question I have relates to the quarterly 19 notices. 20 The basic position that you've got is that the 21 changes to the list of items relied on for safety should be 22 reported to the Commission quarterly and you relate the list 23 as being analogous to the tech specs in power reactors. 24 Industry argues instead that these items are more 25 closely associated with the Q list and they believe that the 20 1 quarterly reporting is not appropriate and that it should be 2 yearly reporting. 3 Now, it could be argued, I suppose, that if indeed 4 these items that we are requiring quarterly reporting on 5 are, in fact, equivalent to the tech specs, that we should 6 require prior Commission approval, again, analogous to the 7 reactors. 8 So it seems to me that we've come down somewhere 9 in between. We're allowing a change to be made, but we're 10 requiring them to be reported quarterly. 11 So I'm wondering if you could flesh out for me the 12 differences that you have with the position being -- that 13 we're going to hear a little later from NEI regarding the Q 14 list and how we should respond to those concerns. 15 MR. PERSINKO: Regarding your question about the Q 16 list, the Q list is normally a list of components, not 17 necessarily with any descriptive information along with it. 18 The list of items relied on for safety that's in the Part 70 19 rule is a descriptive list, it's functional descriptions 20 that go along with it. 21 So it's the combination of the functional 22 description, along with the items, which can be on a system 23 or a component level, that really give the staff its 24 assurance that the performance requirements are being met. 25 So in that respect, we think it is more analogous 21 1 to the technical specifications. 2 COMMISSIONER MERRIFIELD: Okay. But in that 3 regard, the pregnant question is why didn't we, therefore, 4 require a prior approval by the Commission before those 5 changes were made? 6 MR. PERSINKO: It has to do with the staff's view 7 of maybe the risk associated with the facility being less 8 than reactors. Also, the process, the change process is 9 different, as well, than what the reactors use. 10 So the staff felt comfortable, based on the change 11 process in the 70.72, that it didn't require pre-approval, 12 but it would get a rather relatively up-to-date view of 13 those changes after the change is made. 14 COMMISSIONER MERRIFIELD: That's fair. Now, in 15 the backfit, we've got sort of a two-part issue. Obviously, 16 for part of this, the backfit test would be implemented 17 within six months and then for that portion where we're 18 relying on the ISA summary, we're going to wait until after 19 that is involved and so we're focusing. 20 The issues associated with the backfit test that 21 are raised by NEI primarily revolve around that subpart (h). 22 Given the fact that the industry has to 23 demonstrate compliance with the regulations and then 24 generally backfit doesn't apply to demonstrating compliance 25 with regulations, what is it -- I'm going to direct this to 22 1 the folks at NEI, as well. What is it that is to be gained 2 by making subpart (h) effective immediately? Why is it that 3 this is so important to make it effectively immediately? 4 MS. ASTWOOD: Your question of making it effective 5 immediately, we were trying to address the public comments 6 that requested that it be effective immediately, and we felt 7 we could do that for those areas that we had a baseline that 8 we could apply it to. 9 We don't feel that we have the baseline or the 10 experience for applying the backfit to the other -- 11 COMMISSIONER MERRIFIELD: That's fair. I guess 12 the question I'm asking really isn't necessarily directed to 13 you, but I want to get sort of your reaction to it. 14 The industry has got to comply with the 15 regulations, but backfit doesn't apply to comply with 16 regulations. So what is it that is to be gained from making 17 subpart (h) -- what was the explanation for making subpart 18 (h) effective immediately, since they still have to 19 demonstrate compliance? 20 MR. WEBER: Because what the agency is attempting 21 to do, if the Commission approves the requirements, is to 22 get on with the implementation of the integrated safety 23 analyses and to do that, I think the industry would benefit 24 from having a final rule that's applicable and they need to 25 comply with. 23 1 Recall that once the rule goes into effect, the 2 industry has got six months to do their initial plan and 3 then to get on with completed their integrated safety 4 analyses and preparing the ISA summaries, and ultimately 5 implementing whatever safety measures come out of that 6 analytical process. 7 If the alternative that you're perhaps 8 contemplating would be a deferred implementation of subpart 9 (h), the question would be what confidence does the industry 10 have to go forward and expend the resources to do the 11 analyses, not knowing that those requirements apply to them. 12 I think that might be a bit of a concern for the licensees. 13 On the other hand, if we go forward now and begin 14 implementing the ISAs and developing the ISAs, with a 15 deferred implementation of the backfit, then we do not have 16 to go through the backfit exclusion for compliance every 17 time a change is made or at the time staff reviews the ISA 18 summary that comes in from the licensees during that four 19 years. 20 So there is an administrative convenience, as well 21 as the economy of not having to go through that part of the 22 process. 23 And recall, the ISA summary provides the baseline 24 that we will then use as we go forward with the 25 implementation of backfit to compare against. 24 1 COMMISSIONER MERRIFIELD: That's fair. The last 2 question I have, very briefly. We have a lot of issues and 3 the Commission has placed a lot of issues before the staff 4 relative to Part 70, all of the work you've been doing here, 5 as well as consideration, you've recently touched on it, of 6 the issue of a new assessment and oversight program. 7 Have you received concerns from the industry about 8 perhaps we're doing a little bit too much too soon? Is the 9 area of a new assessment and oversight program an area where 10 perhaps given the fact we're still evaluating our results on 11 the reactor side, that there may be some usefulness maybe to 12 taking a little bit more time to consider where we go 13 relative to Part 70 licensees? 14 MR. TRAVERS: I think the answer to that -- I 15 don't think. I know the answer to that question is yes. I 16 had a discussion with some of the representatives yesterday 17 in a drop-in and basically the issue is should we drop back, 18 would they be interested in dropping back, would other 19 stakeholders be interested in dropping back a bit and making 20 an assessment of the applicability of something like what 21 we've done for reactors in this program or not. 22 What makes sense from a holistic, sort of 23 integrated perspective? We agree that's a good idea and we 24 agree that some sort of near-term stakeholder meeting is 25 appropriate, so that we can involve all stakeholders in a 25 1 broad assessment of going forward and just how to do that. 2 COMMISSIONER MERRIFIELD: Okay. 3 MR. PAPERIELLO: If I could make a comment, 4 because the revision of the inspection program for fuel 5 facilities in NMSS was an initiative I took before I assumed 6 the current position. 7 You need to realize the current inspection program 8 was driven by the reaction to the events that caused us to 9 develop these rule, the development of the rule. 10 Essentially we attempted to inspect quality into 11 the program. The resources are relatively high and I say 12 that relative to where we stand now on the reactor side. So 13 the initiation of the program to re-look at the inspection 14 program was recognition that we had created a program to 15 inspect quality and maybe the resources were not quite 16 balanced, particularly with the implementation of this 17 particular rule. 18 So I'm just trying to frame the reason why we did 19 it. It was not meant to copy the reactor inspection 20 program, but what was initiated was an attempt to come up 21 with a program that was consistent with this rule and not 22 how we had actually created an inspection program in 23 reaction to the events that occurred a number of years ago. 24 MR. WEBER: If I can add to that. There are many 25 attributes that we see in the revised reactor oversight 26 1 program that are appealing to us within the staff. There is 2 greater efficiency in some areas. There are opportunities 3 to address cross-cutting elements of licensee performance 4 that are appealing. 5 The concept of risk-informing our inspection and 6 the oversight process is very appealing to us. And those 7 are the base attributes that we're striving for as we go 8 forward with the oversight process. 9 There is the whole licensee performance review 10 process that we go through. We think that there is a way to 11 make that a little more systematic, more objective, to 12 provide the information in a more timely way. 13 So all those elements that have been affirmed in 14 the revised oversight process for the reactors are very 15 appealing to us in the fuel cycle program. 16 Now, having said that, we certainly have heard 17 from the industry concerns not only about, hey, let's take 18 this in a measured way, let's not leap before we know where 19 we're going to land, but we've also heard that in some ways, 20 the stakeholders are strapped for resources to participate 21 in the public effort that is required to develop this new 22 oversight process in a way that's going to share broad 23 ownership to that revised oversight process. 24 Many of the individuals that we have the benefit 25 of interacting with from the licensees are, in fact, safety 27 1 managers back at their plants. So every time they come to 2 Washington or go to one of our regional offices, that's a 3 day or two days or three days that they're away from the 4 licensed facility. That means they are not doing their 5 normal safety function, managing a part of the program or 6 contributing to that program, and we've heard that. 7 In addition, I only have part of the program that 8 affect these licensees. They're also interested in 9 transportation safety, the revisions of ST-1, and the 10 implementation of that rulemaking. 11 So I think the licensees legitimately have raised 12 a concern of looking at the integrated programs and not just 13 what are we doing in the revision mode, but also major 14 licensing actions that are coming up that they need to 15 invest their effort and attention to so that they come off 16 in the best way. 17 COMMISSIONER MERRIFIELD: Mr. Chairman, I think 18 this raises a fair point about resources. It is somewhat 19 refreshing to say that we're in a position as an agency of 20 perhaps being ahead of our licensees, and I think that's a 21 recognition that the staff is doing a good job. 22 The only supplement I would add to the list that 23 Mr. Weber had for all of the good things about our new 24 reactor oversight process is increased public confidence, 25 which I think is something very meritorious about our new 28 1 system. 2 Thank you, Mr. Chairman. 3 CHAIRMAN MESERVE: I'd like to follow up for a 4 second on the backfit issue, and then let me say that I'm a 5 newcomer, again, to this game, on this Part 70. 6 But I would have understood that you don't have 7 any backfit issues as to the promulgation of this rule 8 because the existing Part 70 doesn't have a backfit 9 provision in it. So you can proceed to promulgate. 10 MR. WEBER: That is correct. 11 CHAIRMAN MESERVE: And the question I have, 12 therefore, is why not make the backfit provision immediately 13 effective, because it seems to me that to the extent the 14 issue you raised was to the ISA summary is adequate, you 15 have the benefit of the analogy you have to the reactor 16 backfit rule, which is the compliance exception, and you 17 will be defining -- and as you go forward, you'll be 18 defining what compliance with this rule means and you have 19 an exception that's built into the backfit rule that covers 20 that situation, so you don't have to do a backfit analysis 21 for that. 22 I'm sort of wondering what are the stakes here. I 23 don't quite understand why the staff has wanted to delay the 24 -- with Commission guidance, in fairness, why there was this 25 pressure to delay the backfit applicability given the fact 29 1 that there is a compliance exception in the backfit part of 2 the rule. 3 MR. VIRGILIO: Mr. Chairman, if I could take a 4 shot at that. One reason, as you've pointed out, is the 5 compliance issue and we really don't want to have any 6 impediments to getting the rule implemented. 7 The other issue, from my perspective, is how do 8 you go about doing a cost-benefit analysis. I think the 9 process will be greatly informed by the methods that the 10 applicants and licensees choose to use in performing their 11 ISAs. We offer a range of methodologies. Some have already 12 started using the index method that we have as an example in 13 our standard review plan. 14 I don't think anybody is going to go to a PRA and 15 we're not pushing or encouraging that, but there are a range 16 of methods that people could use. 17 I think when I step back and say, then, how would 18 I go about approaching a cost-benefit analysis, I would like 19 to be informed by some of those methods. So, therefore, I 20 see a tremendous benefit in holding back and seeing how this 21 is developed and then performing our cost-benefit analysis 22 methodologies based on what is actually implemented by the 23 licensees and applicants. 24 CHAIRMAN MESERVE: I can appreciate that, that if 25 you actually had to do a backfit analysis, you'd like to 30 1 have some experience with this rule so you could understand, 2 using the ISA as the backdrop for doing it. 3 But the issue that was raised is that in the ISA 4 summary that would be submitted, that that would somehow 5 become a backfit, and I would have thought that you wouldn't 6 have to have done this cost-benefit analysis because you 7 would be defining for that what compliance with the rule 8 means. 9 MR. VIRGILIO: Yes. We are in agreement. 10 CHAIRMAN MESERVE: So you have the exception that 11 gives you basically the opportunity to avoid having to do 12 the cost-benefit analysis as you're approving those ISA 13 summaries. Am I missing something? 14 MR. VIRGILIO: No. It should flow right through, 15 but hopefully we wouldn't get embroiled in any discussions 16 about what is compliance and what isn't compliance with the 17 rule, and we wouldn't want to have a burden imposed on us or 18 the licensees or applicants for going through that. 19 We would just like a smooth process that would 20 expedite the implementation for the rule, form a baseline, 21 and from that baseline, then we go to it's either a 22 compliance backfit beyond that baseline or it's a 23 cost-beneficial enhancement beyond that baseline, but it 24 would allow us, I think, a smooth and expeditious transition 25 to the implementation of the rule. 31 1 MR. TRAVERS: It may be a distinction with not a 2 great deal of practical difference, but the thought was a 3 clear statement of the applicability once this baseline was 4 established, the need not to have to go through the 5 determination of backfit exception, if it were immediately 6 effective, where attractive, and just raising the issue with 7 the Commission and making sure we are all on the same page 8 relative to going forward with all this. 9 But in the main, though, you're correct. If you 10 establish the ISA summary and the expectation that that is 11 compliance or is the required compliance with the new rule, 12 then we could clearly establish the need not to apply 13 backfit to that particular exercise. 14 CHAIRMAN MESERVE: I have a related question, and 15 this may also reflect my ignorance of where you are. Your 16 slide eight that you have would require submission, as I 17 read it, of ISA plans within six months, but the guidance 18 not to be due for an additional six months, namely a year. 19 So it looks as if you are requiring submission of 20 a plan to do something that you haven't defined until six 21 months later. 22 MS. ASTWOOD: Right. I can answer that one. The 23 ISA plan is simply a document that the licensee tells us 24 their schedule for implementing their ISA, how they're going 25 to do it, their methodologies that they're going to use. 32 1 The documentation that we're developing later is the amount 2 of information, the things that are in the ISA summary which 3 is submitted at the four year mark later on. 4 So we're not developing guidance on how to develop 5 an ISA plan, although we have had discussions with the 6 industry that that is something that they would like us to 7 work with them between now and the six month period. 8 MR. WEBER: Keep in mind, also, that, from what we 9 have already presented, the industry has made substantial 10 progress in developing that guidance document and we're 11 already reviewing or we will soon review the third draft of 12 that document and each time we're coming closer to defining 13 success. 14 So it's entirely conceivable that that guidance 15 that's listed here at six months out will be available 16 within three months and if that's the case, tremendous, 17 because then it will be available as the licensees develop 18 their plans. 19 But as Heather pointed out, what really the plans 20 address are schedules and methodologies. Also keep in mind 21 that many of the licensees are well progressed in developing 22 their integrated safety analyses. 23 So for them, the task of developing their plan is 24 one of how do I take what I've already done and now use that 25 to respond to the rule, and do I do that by bits and pieces 33 1 or do I want to submit one holistic integrated safety 2 analysis. 3 That's the real value of that plan, so that there 4 can be interaction early on between the agency and the 5 licensee and so there's no surprises in the future when the 6 actual ISAs are submitted. 7 CHAIRMAN MESERVE: I think that's helpful. It 8 seems to me that even setting a schedule does require you to 9 have a pretty good idea of what you're required to do. But 10 it sounds to me that you think you're far enough along and 11 your licensees are far enough long that they're going to be 12 able to accommodate that. 13 MR. WEBER: And specifically to that point, sir, 14 the SRP is, in large degree, received well by the licensees. 15 We're talking about level of detail that needs to be in 16 there in chapter 3. We're not talking about differences on 17 methodology or about intent or application. It's really the 18 level of detail, what needs to be in the ISA summary, how 19 does it all get linked together. 20 CHAIRMAN MESERVE: Okay. I have some other 21 questions I could ask, but I do want to allow time for my 22 colleagues. Commissioner Dicus. 23 COMMISSIONER DICUS: Thank you. I want to go 24 through two lines of questioning rather quickly, I hope. 25 One has to do with the quarterly reporting for the IROFs and 34 1 the other one will go a little bit into the ISA summary and 2 some questions regarding that. 3 The industry will tell us today, maybe, unless 4 they've changed their minds in the last 18 hours, but they 5 may tell us that these quarterly reports of items that are 6 relied on for safety could be as many as 20 to 50 per 7 quarter, which the numbers surprise me. 8 MR. WEBER: Per licensee? 9 COMMISSIONER DICUS: Per licensee. The number 10 surprised me quite a bit. I thought that was a very high 11 number. My impression was that if you've got a good ISA, 12 that you should not have very many of these quarterly 13 reports, but the industry told me no, we're getting really 14 down in the grass on these items relied upon for safety and 15 there will be a large number of these quarterly reports, and 16 that's a burden to them. 17 So I need some feedback. Do you agree or 18 disagree? 19 MR. WEBER: I disagree. 20 MR. PERSINKO: That number appears high, to me, 21 especially considering that the industry has indicated they 22 plan to identify the items relied on for safety on a systems 23 level. So that further -- I would expect that further would 24 reduce the number of changes if you identify your items on a 25 systems level. So that number appears high, to me, per 35 1 quarter. 2 COMMISSIONER DICUS: It may be something, when the 3 industry comes to the table, they've had a chance to listen 4 to this, their explanation that they gave to me yesterday on 5 a drop-in on why the number would be so very high. 6 So I think perhaps we obviously have a difference 7 of opinion here and I think getting that resolved is 8 resolution perhaps of this quarterly report issue. 9 MR. PERSINKO: Let me just clarify. That would be 10 one report, though, for the quarter. It's just one report 11 with 50 changes in it. 12 COMMISSIONER DICUS: Right, per licensee. 13 MR. WEBER: Right, but not 50 separate reports. 14 COMMISSIONER DICUS: Well, it would be one report, 15 but it would have all these items in it. 16 MR. WEBER: Right. 17 MR. PERSINKO: That is one thing we tried to 18 clarify in the final rule, because in the proposed rule, 19 there appeared to be a misunderstanding in that one of the 20 comments made at the time was that there would be 21 continually a reporting requirement. 22 That's why we changed the words in the rule from 23 90 days, in the proposed rule, to quarterly. So the maximum 24 number of reports we see before, and it could be less if 25 there were no changes to the items relied on for safety 36 1 within that quarter. 2 COMMISSIONER DICUS: Understood. Let me go now to 3 the ISA summary. The first question really goes to this 4 concept of approving the ISA. Now, my understanding is this 5 approval is a one-time thing, right or wrong? 6 MR. VIRGILIO: Right. 7 COMMISSIONER DICUS: One-time thing. 8 MR. VIRGILIO: Yes, correct. Unless they chose to 9 parse it, Commissioner. They could choose, for example, to 10 do it on a system by system basis. This is something that 11 we heard yesterday. And then we would approve it that way. 12 But our thoughts are it's a one-time approval. 13 MR. WEBER: There would be additional ISA 14 summaries for new processes that would come on line at some 15 point or new facilities. 16 COMMISSIONER DICUS: That's understood. Those 17 would have to be approved, too. What does the concept of 18 approval mean? It's not part of the license and I guess 19 what I'm really going toward is that in approving the 20 license itself, you're approving the safety program. So 21 isn't that essentially the same thing as approving not only 22 the ISA, but the ISA summary? 23 So I'm asking the question why are we approving 24 the summary? Would you have this in a brand new license, a 25 new facility coming on line? Would you still require this 37 1 and if so, why? 2 MR. PERSINKO: Would you require approval of the 3 ISA summary? 4 COMMISSIONER DICUS: Yes. 5 MR. PERSINKO: You're approving the ISA summary 6 along with other information that is submitted. You would 7 be -- by issuing the license and writing the staff safety 8 evaluation report, you would be, in effect, approving the 9 ISA summary, and that's what we anticipated, was that you 10 would be issuing a -- 11 COMMISSIONER DICUS: You're talking about for a 12 new licensee. 13 MR. PERSINKO: For a new licensee. 14 COMMISSIONER DICUS: Okay. 15 MR. PERSINKO: For existing licensees, you would 16 have amendments. You would also get -- you would approve -- 17 you would have -- by approving an amendment, you would be 18 approving any changes to the ISA summary, as well, if that 19 was needed. But the idea was that it wouldn't be approved 20 as a stand-alone document. It would be approved in the 21 context of a license or an amendment to a license, along 22 with other information. 23 COMMISSIONER DICUS: What about existing 24 facilities? I'm trying to get what is the health and safety 25 benefit of approving the ISA summary for existing licensees? 38 1 What are we accomplishing? 2 MR. WEBER: What the staff is saying is by 3 approving the ISA summary, we would be saying that we find 4 acceptable the submittals from the licensee that they are in 5 compliance with the requirements in subpart (h). 6 COMMISSIONER DICUS: But it's not part of the 7 license. 8 MR. WEBER: It's not part of the license. 9 COMMISSIONER DICUS: When they send in changes -- 10 MR. WEBER: If they need to send in changes. 11 COMMISSIONER DICUS: Okay. Well, say the 12 quarterly reports on IROFs, are you going to approve those? 13 MR. WEBER: No. 14 COMMISSIONER DICUS: Okay. 15 MR. WEBER: Now, we will review those to determine 16 whether they still fit within the safety envelope that was 17 established for the facility through the ISA summary and if 18 we find that they trip over any of the criteria in the rule, 19 we may go back to them and, as is done in the reactors and 20 as is done in GDPs, say we've made a review of what you 21 submitted and we've determined that you fall outside of the 22 bounds of the safety envelope. 23 COMMISSIONER DICUS: Okay. 24 MR. WEBER: In which case, if you want to 25 implement that change, you'll need to submit an amendment 39 1 request. 2 COMMISSIONER DICUS: That's fair, and that I 3 understand. I'm still struggling just a little bit with 4 this approval situation. But let me go on from here. 5 Do you have any idea where the licensees stand 6 today on their ISA development progress? 7 MR. WEBER: I don't think we have the specifics 8 here, but all but one, I believe, have committed and have 9 license requirements, conditions in their licenses to 10 complete ISAs. 11 Some are very well advanced in developing their 12 ISAs and have implemented the controls. Others are not as 13 far along, but -- so it's a range. But we have, at this 14 point, I believe, enough experience from the licensees that 15 they've actually tried a variety of different methods and 16 have incorporated them into their own internal safety 17 programs, so we have the benefit of that experience. 18 But they haven't gone the full measure of 19 developing an ISA summary that applies across the board. 20 COMMISSIONER DICUS: So it's fair to say perhaps 21 that some licensees will get their ISAs in sooner than four 22 years. 23 MR. WEBER: I would expect that would be the case. 24 But they still have the full four years. 25 COMMISSIONER DICUS: Okay. Understood. How far 40 1 -- have you done much of a section by section comparison of 2 the new subpart (h) with where licensees are today to kind 3 of have some idea of how much work they have to do? Do we 4 have any feel for that at all? 5 MS. ASTWOOD: It is in the regulatory impact 6 analysis. I know specifically for the management measures 7 area, we did an extensive review, most of the management 8 measures area, we felt that they -- the amount of effort 9 involved is not voluminous to come up to compliance with 10 that chapter. 11 COMMISSIONER DICUS: Okay. I may put that same 12 question to the industry. One last quick question, Mr. 13 Chairman, that follows off of your question on backfit. 14 If it were a brand new licensee and you grant the 15 license today, would backfit apply immediately? 16 MR. WEBER: Well, we'd still have the six months 17 to develop the guidance, but at that point it would. 18 COMMISSIONER DICUS: Okay. Thank you. Thank you, 19 Mr. Chairman. 20 CHAIRMAN MESERVE: Commissioner Diaz. 21 COMMISSIONER DIAZ: Thank you, Mr. Chairman. I 22 thank my fellow Commissioner for an excellent job of going 23 through all the questions that I have. 24 COMMISSIONER DICUS: It's one of the disadvantages 25 of being down the line. 41 1 COMMISSIONER DIAZ: Or the advantage. 2 COMMISSIONER DICUS: That's true, that's true. 3 That's happened to me before. 4 COMMISSIONER DIAZ: I think it's great. Just one 5 question on the issue of the level of detail between you and 6 the licensees, and chapters 3 and 11. 7 Could you tell me what are we talking about, what 8 specifically additional level of detail? Are we talking 9 something very massive or what is the difference in the 10 level of detail that we are asking for in what the licensees 11 are preparing? 12 MR. PERSINKO: We discussed this at the June 8 13 meeting with respect to both chapter 3 and chapter 11. We 14 went over examples that we had developed and like I said, it 15 appeared to be generally well received. 16 One of the, I think, misconceptions that came out 17 at that meeting was it appeared that the industry thought we 18 were requesting information at a procedural level, which 19 would be at a plant procedure, and we were clear at the 20 meeting that we were not looking for that kind of detail. 21 We actually, in our example, tried to use the 22 example to show the information that we would be looking 23 for. And that information is what we were looking for is so 24 that we have the reasonable assurance that the performance 25 requirements were met. 42 1 But, no, I think we were clear at that meeting we 2 don't believe it would be voluminous. 3 MR. WEBER: To place it into some context, let me 4 describe, I believe, where we started out this discussion. 5 The staff laid out, in fairly excruciating detail, in the 6 standard review plan, the level of detail that we were 7 seeking and it was based on the experience gained through 8 the years in doing licensing reviews and, as Carl pointed 9 out, responding to events where it became evident that a 10 particular licensee had a problem, a performance problem, 11 and the fix to that problem was either putting in place 12 configuration management or a maintenance program or 13 something of that effect. 14 On the other side, what we heard from some of the 15 industry folks was what we want to come in with in our 16 license applications is nothing much more than we will have 17 a maintenance program. It's a broad commitment. We will 18 have a training program and the staff, of course, reacted to 19 that by saying, oh, come on, you know, what benefit do we 20 derive from having that high level commitment. 21 Yes, we need that high level commitment, but we 22 need some more stuff there that we can look at to develop 23 confidence that you will operate this facility safely, that 24 you have the controls in place to maintain worker safety and 25 public safety, and that's where the two ends of the spectrum 43 1 started. 2 And I think through the back and forth, both 3 parties have benefited by the exchange of information and we 4 have come to realize, at least on the staff's part, that 5 we're really not that far off. And in some cases, what the 6 licensees have in their existing licenses today may be more 7 detailed than what we're looking for under the new rule. 8 COMMISSIONER DIAZ: All right. Thank you, Mr. 9 Chairman. 10 CHAIRMAN MESERVE: Commissioner McGaffigan. 11 COMMISSIONER McGAFFIGAN: I'm going to follow-up 12 on a question that Commissioner Dicus asked you. The 13 approval process for an existing licensee of the ISA 14 summary, do you envision doing an SER, that that will be the 15 mechanism for providing that approval? 16 MR. WEBER: Yes. 17 COMMISSIONER McGAFFIGAN: That's straightforward. 18 The flexibility you gave licensees with regard to the 19 four-year requirement, you described it, Mr. Persinko, in 20 your comments as items beyond the control of the licensee, 21 but the actual words are a little more flexible than that, 22 it strikes me. 23 If the Commission determines that the alternative 24 is warranted by consideration of the following, adequate 25 compensatory measures have been established, whether it is 44 1 technically feasible to complete the correction of 2 unacceptable performance deficiency within the allotted 3 four-year period, other site-specific factors, one of which 4 is that they are beyond the control of licensees. 5 So there is an awful lot of flexibility for more 6 than four years. I guess the one that bothers me most is 7 the one whether, after all this time, it's the B, whether it 8 is technically feasible to complete the correction of the 9 unacceptable performance deficiency within the allotted 10 four-year period. 11 That's all new, isn't it? 12 MR. WEBER: We modeled that -- that is new, but we 13 modeled -- it's in response to the public comments and we 14 modeled it after the language that's in the existing 15 decommissioning timeliness rules in Parts 30, 40 and 70, 16 where there is a similar provision in which the Commission 17 granted flexibility to itself to determine when alternative 18 schedules for decommissioning are appropriate. 19 COMMISSIONER McGAFFIGAN: I'm just troubled a bit 20 by subparagraph B, to be honest. The change process, I 21 guess I will hit the same point everybody else has. 22 The analogy to tech specs of these changes to 23 items important to safety, that isn't really connecting with 24 me. One of the lines of questions we've had in previous 25 Commission meetings that led to changes in this document, I 45 1 believe, was the original concern of licensees was that 2 without the flexibility of 70.72, they'd be - you guys would 3 be approving license amendments daily and for each licensee, 4 and that was way beyond what we currently do and there was 5 no real rationale for doing it. 6 I think we're back now to, under 70.72, approving 7 about the same number of changes. Is that -- well, I'll ask 8 the question. Is it correct that what we envision under 9 70.72 for a particular existing facility is about the same 10 number of license amendments as we get today, approximately? 11 MS. ASTWOOD: That's what we were shooting for, 12 yes. 13 MR. WEBER: But I'd point out that there is a fair 14 amount of uncertainty in that expectation, because it's not 15 clear to us exactly what the licensees will choose to do 16 under the rule and how they construct their own safety 17 programs will, in effect, dictate the number of amendments 18 that will be required. 19 In other words, if they come in at a fairly high 20 level, they can provide the assurance that is needed and 21 required by the rule, and yet will not result in the same 22 frequency of amendment needs. 23 On the other hand, if they choose to come in at a 24 very detailed level and apply management measures to a wider 25 range of IROFs, as we refer to them in the rule, then that 46 1 could provoke more amendment requirements. 2 COMMISSIONER McGAFFIGAN: If I'm listening in the 3 audience, I think I'm going to take option A. 4 MR. WEBER: But the important thing is the 5 licensees have that flexibility with the way we've created 6 this risk-informed performance-based rule. 7 COMMISSIONER McGAFFIGAN: So approximately we 8 think we'll get the same number of change requests, but it 9 could vary on how much detail they provide in the ISA 10 summary. 11 MR. WEBER: Right. 12 COMMISSIONER McGAFFIGAN: One of the responses to 13 Commissioner Dicus was that it looks like the items relied 14 on for safety are going to be at a system level. But if 15 they are at a system level, it strikes me you're going to 16 get more of these quarterly -- more items included in the 17 quarterly report, because it says for any change that 18 affects the list of items, systems level items, relied on 19 for safety contained in the integrated safety analysis 20 report, but do not require NRC prior approval. 21 That's a pretty broad requirement. If you're 22 identifying items relied on for safety at the system level, 23 any change, you will be giving us quarterly reports on, and 24 it could be quite trivial, because like you said earlier, 25 they could have gone down into a subsystem level and then 47 1 the whole system wouldn't have been relied on for safety. 2 But now because they're making changes in things 3 that really aren't all that important to safety, we're 4 triggering larger lists of items to report on quarterly. 5 I don't know. As I say, that's not a tech spec, 6 in my mind. 7 MR. PERSINKO: It depends how it's presented in 8 the application. It's a function of how you describe the 9 system and the functions of the system that go along with 10 the system. If it's truly at a higher level, this is the 11 system and these are the functions we want that system to do 12 to meet the performance requirements, I would expect there 13 to be less changes to that, because I think you can change 14 components within the system. Not every component in a 15 system would be a safety-related component. 16 Even then, if you don't describe on a component 17 level in your application, changes can be made to components 18 as long as the functions described in the application and 19 the system don't change. 20 COMMISSIONER McGAFFIGAN: It's just -- do you want 21 to follow-up? 22 COMMISSIONER DICUS: Go ahead. I do want to 23 follow-up. 24 COMMISSIONER McGAFFIGAN: It just strikes me that 25 the words here, though, are quite -- I mean, there's a -- 48 1 you're setting up gaming processes for how one is going to 2 do the ISA summary in such a way as to not trigger as many 3 quarterly reports and the words actually are for any changes 4 that affect the list of items relied on for safety contained 5 in the ISA summary, but do not require prior approval, they 6 have to submit revised pages. 7 So it depends on how things go, but it could be 8 voluminous, what they're saying could be correct depending 9 on how they do the ISA summary. 10 MS. ASTWOOD: Okay. Could you do that one more 11 time? 12 COMMISSIONER McGAFFIGAN: For any changes that 13 affect the list of items relied on for safety contained in 14 the ISA summary, but do not require NRC prior approval, a 15 licensee shall submit revised pages of the ISA summary. 16 MS. ASTWOOD: On an annual basis. 17 COMMISSIONER McGAFFIGAN: To the NRC quarterly, 18 within 30 days after the end of the quarter. So that's the 19 quarterly report. 20 MS. ASTWOOD: Right. 21 COMMISSIONER McGAFFIGAN: And as I say, if they're 22 identifying things at a system level, you do get to the 23 numbers that Commissioner Dicus -- I'll let Commissioner 24 Dicus follow up. 25 COMMISSIONER DICUS: I think clearly on this 49 1 language is the interpretation, maybe I shouldn't speak for 2 the industry, but my sense is that their interpretation of 3 this language does mean if you noodle any little thing in a 4 system, that that's got to be reported, and maybe we need to 5 clarify the language or maybe clarify and make it clear what 6 the interpretation of that actually means. 7 We do have a pretty good difference in opinion on 8 how many items might be reported. 9 MS. ASTWOOD: I agree. I want to reiterate what 10 he said about -- we did not want to see changes where they 11 change the paint color or put in different bolts. That 12 absolutely was not our idea. 13 However, the list of items relied on for safety, 14 assuming a systems or component level, would be the item, 15 the system or this component, with, like he said, a 16 descriptive list. We have this component to measure 17 temperature or regulate something. Now, changing that bolt 18 or changing the color of that does not change that list. 19 COMMISSIONER McGAFFIGAN: I'll quit that line of 20 questioning. I'm still at a year, like I said, when I voted 21 the last time. One other issue that came up in my voting 22 last time that doesn't seem to -- it didn't reach the issue 23 of important stakeholder comments, but it was this issue 24 that I remember NEI raising with regard to 70.61(e) and 25 70.62(d), the use of the word "ensure"" as opposed to 50 1 "provide high insurance"" or something like that. 2 The safety program established and maintained 3 pursuant to 70.62 of this part shall ensure that each item 4 relied on for safety will be available and reliable to 5 perform its intended function. 6 And the issue was what does ensure mean. Ensure 7 could be an absolutist term that 365 days a year, every 8 second of every day, you'll have to ensure that, which isn't 9 possible. 10 So there was discussion, at least last time I 11 recollect, of words like provide reasonable assurance, 12 provide high assurance, provide some level of assurance, 13 rather than assure in those sentences. 14 How was that comment resolved? 15 MR. WEBER: We did receive public comments on that 16 very language and I believe our resolution was it is the 17 Commission's determination that reasonable assurance exists, 18 not the licensees'. The licensees are obligated to comply 19 with the requirements and the licensee also has the 20 flexibility to build within their safety programs various 21 approaches for compensatory measures, for shutting down 22 operations during maintenance, et cetera. 23 So again, the ball is the licensees' court to 24 decide how they're going to provide that insurance. 25 MR. PERSINKO: You ensure that you meet the 51 1 performance requirements at all times, but you can ensure it 2 different ways, depending on the consequences of the 3 failure, the potential failure. 4 And ensure it at the outset, if it's extremely 5 important, you can have completely 100 percent backup or if 6 the consequences warrant, you can factor that out-of-service 7 time, say, into the ISA at the outset and factor it in that 8 way. 9 But you do ensure that you meet the performance 10 requirements. 11 MR. WEBER: If the licensee is relying on a 12 favorable geometry tank and that tank, for whatever reason, 13 becomes unusable, we don't want the licensees to continue 14 operating unless they provide that insurance. 15 On this change control process, Dr. Travers and I 16 had the opportunity to participate in an NEA conference in 17 Japan at the end of May and one of the most striking 18 conclusions that came out of that was an urging that 19 regulatory authorities approve any change to license to 20 operations. 21 Now, we're going forward with the rule because we 22 don't think that that's the right way to go. We think that 23 you can maintain safety, yet allow licensees the flexibility 24 to do their own internal change control, because they've 25 been doing it, a number of them have been doing it for some 52 1 time. 2 COMMISSIONER McGAFFIGAN: Okay. I do think the 3 staff has done a good job the last -- I think this episode 4 started in late '97 and we've been through a lot and I think 5 we're down to a small number of items now and I'm very happy 6 with the process and the staff result. 7 I guess the one last question that I have on these 8 guidance documents, the SRP chapters 11 and 3 that will be 9 still in play after the rule is finalized, if we finalize it 10 as you are recommending. 11 Should those be submitted to the Commission for 12 our information or even as a voting matter as a mechanism to 13 -- is that -- we've done that in some other guidance 14 documents, 50.59 license renewal, 50.65, et cetera, and I 15 know it's not normally -- guidance documents have normally 16 been in the hands of the staff. 17 But is this an important enough one that we should 18 take a peek at it in six months or whenever it's ready and 19 make sure that the issues have been resolved? 20 MR. TRAVERS: Our current plan is not to submit it 21 for Commission approval. Of course, you've done that on 22 occasion and we can do it either way. 23 COMMISSIONER McGAFFIGAN: But you would plan to 24 submit it for information. 25 MR. TRAVERS: Absolutely. 53 1 COMMISSIONER McGAFFIGAN: Okay. 2 CHAIRMAN MESERVE: I would like to than the staff 3 for a very helpful presentation. Clearly a lot of progress 4 has been made and as Commissioner McGaffigan has indicated, 5 we're really down to a relatively small number of issues 6 that are presented to us. 7 So thank you very much. 8 Our next panel consists of Mr. Marvin Fertel, who 9 is the Senior Vice President; Mr. Jack Allen, from 10 Westinghouse; and, Mr. Charles Vaughan, from Global Nuclear 11 Fuel. Good morning. 12 MR. FERTEL: Thank you, Mr. Chairman, and good 13 morning, Commissioners. I won't read my testimony. You 14 have that. What I will try and do is go through using the 15 slides that we prepared and address some of the issues that 16 we've already raised and maybe follow-up on some of the 17 discussion you've already had, and also -- 18 COMMISSIONER MERRIFIELD: Mr. Chairman, given that 19 that's a 15 or 17-page statement, I commend NEI for its 20 wisdom in that regard. 21 MR. FERTEL: Thank you, Commissioner Merrifield. 22 And also reflect upon some of our follow-on discussions 23 among the licensees yesterday and also discussions with the 24 staff, with the drop-in, with Bill Travers and his folks. 25 If I could have the first slide. As I think 54 1 you're aware, there's three rule issues that we would like 2 to discuss. I think all of them were discussed just 3 previously with the staff and I'll come back and discuss 4 each one of these individually. 5 Next slide. And there's basically two chapters, 6 chapter 3 and chapter 11 in the SRP that we're going to 7 discuss. 8 I think I could second very strongly Commissioner 9 McGaffigan's statement that over the last couple, three 10 years, the cooperation, the work and the progress between 11 the NRC staff and the industry has just been exemplary. I 12 think there has been tremendous progress made. 13 I think that the characterization that Mike made 14 of where we were maybe on chapter 11 might have been a 15 little extreme on the ends, but I think that where we got to 16 is probably indication of the good dialogue and the 17 relationship and trust, and the stakeholder meetings have 18 helped. 19 I should point out that all the Part 70 licensees, 20 as well as USEC, are represented in the audience today. 21 There are representatives from every facility here. 22 If we could go to the next slide. The ISA 23 approval, we are recommending that the rule not require 24 approval of the ISA. We are not at all questioning the 25 importance of the ISA, the commitment to do the ISA or the 55 1 submittal or the ISA summary. There is no question about 2 that. We are fully committed to that and have been from the 3 beginning. 4 What we're struggling with is that we see the ISA 5 itself as a tool that's used by the licensees to assess the 6 safety at their facility and to ultimately demonstrate 7 compliance with the performance requirements of 70.61, for 8 the rule itself, and then ultimately if I put in a new 9 process, to demonstrate how that process is safe, or if I 10 want to amend my current license to use the ISA in that way. 11 We see it as a backup document that goes in to the 12 NRC, and I think I agree, and I'm not sure whether it was 13 Bill Travers or Mike Weber or Drew that said that, well, in 14 effect, they're approving a licensing action and de facto 15 you are approving the ISA. We don't question that you're 16 accepting the ISA, you may have questions. 17 What we'd like is you approve the licensing 18 action, not the ISA itself. And it may be a semantics 19 issue, except the rule is pretty clear that it says approval 20 of the ISA summary. 21 So I just want to be clear. We have no question 22 about submitting it, using it, its importance. It is what's 23 being approved that we're questioning and we think the 24 licensing action is the approval, the regulatory action 25 itself, not the ISA, and we're certainly prepared to discuss 56 1 that in more depth at the end of this. 2 The next slide, please. There was quite a bit of 3 discussion on the quarterly updates. Our estimate, which is 4 certainly just an estimate right now, I asked the licensees 5 whether they would think the quarterly reports would be, 6 based upon their experience to date. 7 At least one licensee, who has been looking -- has 8 an ISA in progress, is about halfway done, has items relied 9 on for safety defined, told me yesterday that he estimated, 10 from what he knows, there would be 20 to 30 quarterly 11 submittals. The others haven't given it that much thought 12 yet, even though, off the top of their heads, they had 13 guessed 50. 14 But the one, the more accurate number was someone 15 who actually said, yeah, if I look at my items relied on for 16 safety, I would expect 20 to 30 on a quarterly basis. 17 I think it probably falls a bit into what 18 Commissioner McGaffigan said. I think our intent would be 19 you look at a system level, but obviously, the way it's 20 written, anything that affects that system would then become 21 something I have to report quarterly. 22 I think that just philosophically, where we are is 23 if it's something that requires NRC prior approval, we 24 should get it into you for prior approval. If it doesn't 25 require prior approval, we should report annually. And if 57 1 there is something in between, halfway pregnant, I don't 2 know, Commissioner Merrifield, we should figure out what 3 that is and try and deal with that differently. 4 But we basically would advocate that either it's 5 prior approval or it's an annual report. And we don't feel 6 that that hinders the NRC. I mean, I heard what the staff 7 said and they should be aware of what's happening at the 8 plant on a timely basis and, in fact, they are. 9 I asked the licensees that question when we were 10 getting ready for this meeting and all of them told me that 11 from their experience, the inspectors, the first thing they 12 do when they visit the facility is review the changes that 13 were made since last time they were there. 14 So from an NRC staff standpoint, at least part of 15 the staff is getting that information. So, again, our 16 recommendation would be to try and keep it to annual. If it 17 requires prior approval, let's deal with it. 18 If there is a reason for more information to be 19 presented to headquarters, let's talk about how we need to 20 do that and figure out how to do that, probably not on a 21 quarterly reporting through the change process, but through 22 some other mechanism of maybe meetings where you have those 23 kinds of discussions. 24 Next slide, please. On the backfit provision, I'm 25 going to be on very solid ground right here. I completely 58 1 agree with what Chairman Meserve said in his reading of what 2 the rule and the backfit provision -- he said it much better 3 than I was trying to say it to the licensees yesterday, when 4 I was struggling with -- you know, I'm not quite sure what 5 we're protecting against. 6 Having said that, I found it instructive listening 7 last evening to the staff's arguments, as did some of the 8 licensees, on why they thought they didn't want to make it 9 effective immediately and at least one of the arguments was 10 they needed the ISA summaries as baseline. 11 I think that from our standpoint, we would still 12 argue, and we can talk about this during questions, as to 13 what we see as the risk and I think that was some of the 14 questions that were coming up from the Commission. 15 I think we would still argue that you could make 16 it immediately effective and you wouldn't be hurting your 17 regulatory ability to enforce compliance at all. 18 I think if you decided not to make it immediately 19 effective and you were going to implement the way the staff 20 has proposed, what we would strongly recommend is that the 21 wording be such that when people submit ISAs for individual 22 systems or processes, the backfit provision would become 23 effective immediately upon acceptance of that ISA. I don't 24 need to wait until I've finished all of my ISAs. 25 If you talk with the licensees or the staff, what 59 1 you will find is that it's not a PRA for the facility that 2 we're used to at a reactor. It's a series of ISAs for 3 systems and processes, because this is not one big 4 integrated power plant with I'm trying to protect the core 5 only. 6 So you have a schedule for at least those that 7 have already committed to do ISAs, which have a series of 8 ISAs coming in. And if we were not going to have the rule 9 immediately effective, but it was key to ISAs, what we'd 10 like to do is have it keyed to when the ISA -- not the last 11 one, but as each one is submitted and accepted, that you 12 then have some backfit protection for that particular system 13 or process that they've accepted. 14 The second aspect of our position on the backfit 15 provision, and I know that the Commission had recommended 16 this to the staff, so this is clearly not a shot at the 17 staff, is that we think that the term substantial should be 18 in there. Substantial is in the backfit provision for the 19 GDP. Significant is in there for the reactors. 20 If we were looking at a risk-informed rule, these 21 are probably the lowest risk facilities and we've sort of 22 raised the hurdle on the backfit provision. So we would 23 argue substantial should be in there. We recognize that 24 nobody is quite sure what substantial or significant is and 25 the only thing we know is it's greater than something that 60 1 doesn't say substantial or significant, and at least you can 2 have some dialogue on that. 3 So that would be our recommendation there. 4 We agree completely what you heard the staff say. 5 I think we've made tremendous progress working together on 6 chapter 3. I think, Chairman Meserve, you pointed on the 7 schedule to what appeared to be sort of a discontinuity 8 maybe in when things got delivered versus when things were 9 expected. 10 Our objective right now is to have the guidance 11 document that we're preparing done before the end of the 12 summer. We would like, and this does not agree completely 13 with the staff, we would like the rule not to be effective 14 until the guidance document from chapter 3 is actually 15 endorsed and accepted and I will mention, for chapter 11, 16 until the issues there are resolved and chapter 11 is also 17 complete. 18 So we are making a distinction here between 19 approval of the rule and effectiveness of the rule. I think 20 that going forward on approval of the rule, hopefully with 21 some of our recommendations, you could do and we're not 22 arguing against that, but we would recommend that in order 23 to implement it, when you look at the importance of chapter 24 3 and chapter 11 implementation, that having those chapters 25 finished before the rule becomes effective would actually, I 61 1 think, be an impetus on both the staff side and our side to 2 work hard to get them finished and move into the 3 implementation of the rule. 4 But, again, I want to say that there has been 5 tremendous progress and a lot of good work done on both 6 sides there. 7 On chapter 11, I almost have nothing to add to 8 what Mike Weber said. I think that, as he and Drew said, 9 tremendous progress is being made there. 10 I think there was probably, at the outset, a lack 11 of understanding of what both sides were looking to put in 12 there. I think we're much closer. I think the challenge 13 right now is getting down and making the words reflect the 14 understanding either as a preface or embodied in chapter 11, 15 and, again, I'm not sure that Commission approval, as 16 Commissioner McGaffigan asked, is absolutely necessary, but 17 I think that you ought to be satisfied that the issues have 18 been resolved is what we would encourage before the rule 19 actually becomes effective. 20 In addition to what's just up there as 21 conclusions, which are the items I've covered, one of the 22 things that came out clearly in our discussions among 23 ourselves yesterday, and maybe it came clearer than what we 24 had thought about, and then discussions with the staff late 25 yesterday, was that while there is not a lot of licensees 62 1 here in Part 70, each one is unique in where they sit in 2 both the current licensing process and where they sit 3 actually with one foot, sometimes two feet into the new 4 licensing process. 5 Both gentlemen sitting on my left and right are 6 basically committed to ISAs in their current licenses. 7 They've got a schedule for preparing them. They've got a 8 whole bunch of them prepared. That's true for a number of 9 the facilities in the audience. 10 So what we have is a situation where a number of 11 -- well, everybody is a little different and everybody is 12 somewhere into the new process. Some are entering it for 13 the first time, slowly, others are much further down the 14 road. 15 That struck us as what we really need is an 16 implementation schedule for each licensee. I know the rule 17 requires a plan for the ISA and that was on the schedule 18 that Drew showed. What we would say is we probably need to 19 look at it broader than just the ISA. We need to look at 20 how we implement this new rule for each licensee and 21 actually come up, and there's not that many, which makes it 22 somewhat easy, but each one is different, from what I got 23 out of the discussions I had last evening and this morning 24 with the licensees, the more they thought about 25 implementation. 63 1 They've been focused on the wording in the rule 2 and they've been focused on the SRP and what happened 3 yesterday out of some of the discussions is everybody 4 clicked, oh, now I've got to implement. And it's not as 5 cut-and-dry as it may have seemed to even them. 6 It's probably not as complex as maybe the initial 7 shake-up of, oh, my God, I've got to figure this out, but 8 what we're encouraging is we'd like to sit down with the 9 staff, each licensee would, and develop an implementation 10 plan. 11 And I guess the only thing I'm asking of the 12 Commission is your indulgence of the staff as they would go 13 through that with the licensees and maybe encouragement to 14 do that, which I think they would be more than willing to 15 do. 16 That was all I had. Charlie or Jack, is there 17 something you'd like to add? 18 MR. ALLEN: The only thing I would suggest is that 19 just so you understand that several of us have -- are 20 currently working on and have submitted ISAs and, in the 21 case of Westinghouse, have gotten acknowledgement. 22 We have license commitments and we took this five 23 years ago and have been working very heavily in this arena. 24 Our license requirement also calls for a schedule of 25 criticality safety evaluations. We've submitted 13 of those 64 1 already. We've submitted six ISAs for highest risk 2 processes and we have about 15 more to complete. 3 So literally, this baseline we talked about 4 yesterday has really become a set of stairs to evolve to 5 full implementation. So why we're concerned about how this 6 is implemented is really based upon the fact that we have 7 done work, significant work in submitting ISAs and they have 8 been acknowledged. 9 And so the baseline does exist for certain process 10 elements and at least two others of us have submitted 11 significant ISAs. One this morning said 18 had been 12 submitted, with about four remaining, and one other has at 13 least three submitted. 14 So we are at varied states and so we're not 15 arguing that we're all different. We're arguing that we're 16 involved and have evolved through this process very 17 rigorously, and we did this in a very trusting fashion, 18 saying this was absolutely the right thing to do from our 19 facility standpoints and we'd just like the credit and the 20 implementation associated with the work that's been 21 completed for us to be successful and continuing to move 22 forward without significant rework. 23 MR. VAUGHAN: I don't have anything to add. 24 CHAIRMAN MESERVE: Thank you very much for a 25 helpful presentation. Let me turn to Commissioner 65 1 McGaffigan. 2 COMMISSIONER McGAFFIGAN: Should I start with the 3 Lawyers Entitlement Act? The backfit provision, if you 4 agree with the Chairman, and I listened to the Chairman and 5 the staff talk earlier about the backfit provision and the 6 compliance exception that would be there. 7 It strikes me all you do is force the staff to do 8 a bunch of compliance exception analyses, which lawyers can 9 poke holes at and argue about, and I'm not -- you know, I'm 10 not a lawyer, although Commissioner Merrifield warns me my 11 son might benefit somebody. He apparently wants to be a 12 lawyer. 13 What benefit is there, from a public health and 14 safety perspective, other than employing lawyers? 15 MR. FERTEL: I honestly don't see it being a 16 Lawyers Employment Benefits Act, because the way we're 17 looking at them, I think indications of the way we're 18 looking at is what Jack and Charlie just said about where 19 they are in implementing in ISAs already is that everybody 20 wants to go forward and satisfy the rule. 21 We've worked real hard to get the rule to where we 22 think it enhances health and safety and it's more effective 23 and it's risk-informed and hopefully performance-based. 24 So to be honest, what I see is everybody is going 25 to go forward and implement it and not try and get out of 66 1 satisfying 70.61 requirements, which you can't. 2 What I see, the honest protection is I have 3 satisfied 70.61 and I've got it done already in some ISAs 4 and the staff decides they like what Charlie did at his 5 facility a little better, why don't I do that. 6 COMMISSIONER McGAFFIGAN: Okay. But that gets -- 7 I'm more open to the notion that once an ISA has been 8 submitted and approved by the staff, a piece of an ISA, then 9 you get protection at that point, if that's what you're 10 worried about. 11 If you're worried about one person setting the 12 gold standard in the fourth year and everybody else having 13 to be backfit to the gold standard, even though they've all 14 been approved previously, that I thought was a reasonable 15 suggestion. 16 But we get to this issue of approval. Let me get 17 to the ISA approval thing. For existing licensees, and 18 that's what we're mostly dealing with, we have the MOX plant 19 coming in maybe, but how -- the staff says they're going to 20 do a safety evaluation report on the ISA summary. 21 Presumably they're going to do a safety evaluation report on 22 each of these submittals, if they're coming in system by 23 system. The numbers I think were four to go, 18 done, and 24 various other numbers. 25 Have they been using SERs to approve the ISA 67 1 submittals so far? 2 MR. ALLEN: No. What I had read to me was a 3 letter of acknowledgement of the ISA, and so we are yet 4 unclear how that will all be "approved"" or finally 5 accepted. And I think we would recognize that -- 6 COMMISSIONER McGAFFIGAN: Do you believe that -- 7 and I forget your numbers. Do you believe that the ISA 8 subimttals you've made thus far have been approved by the 9 staff de facto or have they just acknowledged that they have 10 received them? 11 MR. ALLEN: I believe that they are 12 administratively accepted and those were the words that were 13 in the letter of acceptance. 14 I'm uncertain as to whether they've been approved. 15 COMMISSIONER McGAFFIGAN: Well, that's a 16 complication. I earlier, not realizing that the submittals 17 are going to come in one by one, asked the staff whether 18 they were going to do a safety evaluation and they said yes. 19 I guess I should have asked them whether they were going to 20 do a safety evaluation for each piece of the submittal and 21 that that approval can be done partially, or whether the 22 staff envisions only doing an SER -- Mr. Weber is going to 23 the microphone -- only doing an SER on the final summary 24 after all 22 pieces are in, if there are 22 pieces. 25 MR. WEBER: If I could, Michael Weber, from the 68 1 NRC staff. The renewed license that Westinghouse has 2 specifically created a new vehicle to submit these documents 3 and these documents are submitted as an annex, and it 4 explicitly states in their renewal application, which then 5 becomes the licensing basis, that these will not be 6 submitted for approval. 7 So when we talk about approval prospectively in 8 the new rule, that would be a different regulatory framework 9 than the current framework under which Westinghouse is 10 submitting its ISAs. 11 COMMISSIONER McGAFFIGAN: So they aren't approved 12 at this point, but they would be. You would look 13 comprehensively at whatever number of pieces there are at 14 some point or would you look at them piecemeal? You've 15 heard the suggestion that these things may -- you said 16 yourselves, I guess, that they could come in piecemeal and 17 you would handle them one by one, system by system or 18 process by process. 19 MR. WEBER: It depends. Harry Felsher is the 20 either former project manager or current project manager for 21 the Westinghouse and he is also here. But in some cases, 22 what we've done is we've aggregated them together and looked 23 at them as a package. In other cases, if they come in in 24 large sections of the facility, we may look at them 25 individually. 69 1 So it really depends on the scope and breadth. 2 COMMISSIONER McGAFFIGAN: So would your approval 3 process lend itself to a backfit provision that said once 4 you have approved part of the ISA, for purposes of -- that 5 the backfit provision kicks in at that point? Will there be 6 a mechanism for implementing the industry suggestion for, if 7 we chose to amend the backfit provision in the way they have 8 suggested as a fall-back? 9 MR. WEBER: Yes. We will be able to apply the 10 backfit in a piecemeal fashion. 11 COMMISSIONER McGAFFIGAN: Because you'll do 12 multiple SERs, if that's required. 13 MR. WEBER: Yes. 14 COMMISSIONER McGAFFIGAN: Okay. 15 CHAIRMAN MESERVE: Let me make sure I understand 16 this. When you say you have an ISA summary, it's actually 17 the document that you're going to require under the rule, is 18 that an ISA summary of a whole -- of a variety of different 19 ISAs or is it the grand integral of everything? 20 MR. WEBER: It is up to the licensee to determine 21 how they choose to implement that provision and that's why 22 we required the plan to be submitted within six months. 23 For some licensees that have chosen to segment 24 their operation, because of convenience, these aren't 25 coupled systems and they can segregate different parts of 70 1 their program, if they have addressed it in a segmented 2 fashion, we could approve them in that same manner. 3 On the other hand, some licensees may choose to 4 roll them all up into one comprehensive ISA summary and we 5 could also review that. 6 MR. VAUGHAN: Let me just add our experience with 7 the subject of ISAs and ISA summaries. Our license was 8 renewed four years ago, parallel with a significant 9 modification at the plant, where we changed our conversion, 10 the helium part of the plant. 11 And as a part of that activity, we committed to 12 perform an ISA for that new portion of the plant that we 13 were putting in and provide that to the NRC as part of their 14 review not only to that modification to our facility, but 15 also as a part of our license renewal, and, at the same time 16 of our license renewal, we included a chapter in our 17 application which described the processes and techniques 18 that we would use for completing the ISA. 19 And as a part of the license renewal, we committed 20 to the NRC to conduct ISAs for the balance of our plant 21 according to plan which we worked out with the NRC and it 22 did address the balance of the pieces of our plant in a 23 logical sequence. 24 And the reason that we did it that way, so that we 25 periodically provided results of those ISAs or summaries to 71 1 the NRC, was so that this would work would not ball up on 2 both parties and we could proceed through the completion of 3 the work and whatever the review the NRC needs to do of that 4 work on some kind of an orderly fashion over the period of 5 time that it took to complete the plan. 6 And we have been proceeding on that. We have even 7 had some amendments that have required ISA summaries to 8 support them. So we're in a couple of different positions. 9 One, we've had licensing action, which has required ISA 10 summaries to accompany that, and that has resulted not in 11 approval of the ISA summary, but actually approval of the 12 action that was requested of the Commission in that matter. 13 We have some other summaries that have been 14 submitted as a part of this overall plan for which we have 15 no word on precisely what their status is, other than we 16 have furnished those in accordance with the plan. 17 And I will say that the inspection process by the 18 NRC is beginning to use that information because they are 19 inspecting not only a comparison of the total ISA record at 20 the facility, but also comparing that to the summaries, to 21 make sure that they are consistent. 22 And they are also doing what I refer to as 23 vertical slices, particularly of the higher risk items, in 24 their inspection from the summaries and doing a vertical 25 slice all the way down to make sure all of the pieces fit 72 1 together. 2 So that's a summary of the experience that we've 3 had so far with this early implementation of the concepts 4 that we're talking about here. 5 COMMISSIONER McGAFFIGAN: Could I just ask one 6 follow-up? In terms of when you get a license amendment 7 approved, it requires an ISA summary, does the safety 8 evaluation report address the ISA summary as part of the 9 approval of the licensing action, in your experience? 10 MR. VAUGHAN: I honestly did not look at that 11 particular point, but the technical details that are 12 provided in the summary are clearly reflected in the SER. 13 COMMISSIONER McGAFFIGAN: It strikes me that those 14 who don't have licensing actions, there's a benefit to 15 having an SER. So as you said, it may be semantic, but 16 approval, if it means writing an SER to say that this piece 17 is now blessed, if you want the backfit provision to kick in 18 at that point, you have to have some document that says this 19 is now okay. And so that's approval. 20 So I'm not quite sure why you're fighting approval 21 for existing licensees, why you're fighting the words for 22 NRC approval. 23 MR. FERTEL: I think, again, maybe we're thinking 24 about this the wrong way, but let's take a process that's 25 been submitted and let's assume it's under the new rule and 73 1 we want to make sure that you can now apply the backfit to 2 the ISA that was submitted. 3 The approval I would see at that point is a letter 4 back from NRC which says for process XYZ, we agree, and we 5 have an SER backing us up, that you are now in compliance 6 with subpart (h) and that you're complying with the rule. 7 COMMISSIONER McGAFFIGAN: Do you think it's really 8 semantic, that point? 9 MR. FERTEL: Well, they're approving compliance 10 with the rule and I can go change my ISA, which is a living 11 document for us, without asking for a license amendment. 12 It's an analysis document. 13 COMMISSIONER McGAFFIGAN: That's why we gave you 14 70.72, so that you would be able to make changes. 15 MR. FERTEL: Again, this is a tool as opposed to a 16 part of my plan. 17 COMMISSIONER McGAFFIGAN: I've used more than my 18 time. 19 CHAIRMAN MESERVE: Commissioner Merrifield. 20 COMMISSIONER MERRIFIELD: I want to get back to 21 the issue of the quarterly notices. One of the things 22 stated was if there were issues that you felt needed 23 up-front approval, prior Commission approval, let's deal 24 with those things, for instance. 25 In addition, you stated that according to some 74 1 members you have represented here today, there may be 2 another 20 to 30 submittals or 20 to 30 items on the 3 quarterly submittal. 4 We also heard earlier from the staff that they 5 didn't think it was going to be that big. They were 6 surprised by that level. 7 Have you discussed with the staff the notion that 8 there perhaps ought to be items that are up-front that can 9 be reported on a yearly rather than a quarterly basis? 10 MR. FERTEL: We would assume that, the way the 11 change process works, anything that needs to be approved up 12 front wouldn't make it through. So that was sort of a 13 premise that is set up and I couldn't go in and change 14 things, I shouldn't, and the reason I made my statement was 15 the staff keeps going at tech specs as the analogy. 16 Tech specs, at least in my most of my thinking, is 17 limiting conditions of operations and stuff like that. 18 COMMISSIONER MERRIFIELD: It require approval. 19 MR. FERTEL: Right. So if there is something that 20 we have that we shouldn't be changing, I think it's covered, 21 but if it's not, we need to figure that out and talk about 22 it. But the answer to your question is, no, we haven't had 23 that discussion with them. 24 What I heard when the staff briefed you just 25 before us was they thought they ought to know more about 75 1 what's happening at the plant for stuff that doesn't require 2 the prior approval if it relates to an item relied on for 3 safety, and I think our answer is yes, that's probably true 4 and you do it through inspections. 5 And if that's working, I mean, we just heard that, 6 even informally, the inspection process seems to be using 7 the ISA process really well, from what Charlie Vaughan said. 8 So we actually think the Commission is getting the 9 information that they probably need. We're not sure what 10 the quarterly reports would do. 11 The 20 to 30, Commissioner Merrifield, like I 12 said, came out of the discussion with the licensees 13 yesterday and it was from a licensee who actually had given 14 it enough thought based upon what's been going on over the 15 last six or nine months at his facility, and he said, yeah, 16 it's roughly 20 to 30 when I look at my list of items 17 relied on for safety. 18 We haven't done -- no one else had that kind of 19 number and some guessed at maybe 50, but it was a guess. 20 COMMISSIONER MERRIFIELD: It strikes me this is an 21 area worth further discussion between the staff. I don't 22 know if the staff wants the opportunity to comment at this 23 point or not. 24 MR. PAPERIELLO: I'd just note that the objective 25 of receiving the information is to enable staff to not only 76 1 keep up-to-date with what changes are made, but to 2 essentially evaluate whether the change is appropriate. 3 The question is how promptly would the staff get 4 that information. But still the ultimate question is when 5 the staff receives them on an annual basis, they're going to 6 review it and see if the change is appropriate. 7 The advantage of having it quarterly is that not 8 as much time has elapsed, if, in fact, there is a question 9 of the appropriateness of the analysis. 10 So I'm not sure what relevance the number of 11 changes has to this process. 12 COMMISSIONER MERRIFIELD: Well, I guess the first 13 one is are there items out there that don't require 14 pre-approval and perhaps we should think about that, that's 15 one issue. And the second thing is, is the number -- the 16 number isn't really that important, but is there a 17 disconnect between your expectation of what is going to be 18 in the report and what the licensees, based on their 19 interpretation, think they're going to have, is there some 20 way of resolving that? 21 MR. PAPERIELLO: Well, there are some dynamics 22 here. When we had the proposed rule, the concern of the 23 Commission was that the 90-day reporting requirement may 24 change the ISA summary. So we looked at it in terms of, 25 okay, what makes sense. 77 1 I think we didn't look at that in the very first 2 instance. I think the question now is that if staff reviews 3 the items relied on for safety, should that require 4 pre-approval. 5 I think what we're saying is maybe if we're coming 6 up with a proposed -- on the other hand, we don't see an 7 absolute need for the direct parallel. Quarterly reporting 8 would allow -- we're confident that the judgments by the 9 licensees are -- 10 COMMISSIONER MERRIFIELD: That's fair. Not to 11 belabor this, but it's striking a balance. But the issue is 12 do you think there is a need for further resolution of these 13 differences in terms of what items indeed would need to be 14 reported? I don't know the basis or if that makes sense or 15 not. 16 MR. PAPERIELLO: We've talked about it before, how 17 are the items relied on for safety defined, that's up to the 18 licensee. We need enough information about the functional 19 relationship so that staff is able to see how the item 20 relied on for safety relates to the accident sequence and, 21 in turn, how the management measure assures the reliability 22 of that item relied on for safety. So that in itself tends 23 to provide some guidance in terms of how it's 24 characterized. The fact of the matter is an item relied on 25 for safety is the control that we are envisioning to ensure 78 1 that safety. 2 MR. FERTEL: 3 COMMISSIONER MERRIFIELD: One last question. I'm 4 not going to go into backfit. I just wanted to give you an 5 opportunity. I did ask the staff about the amount of 6 changes they're making recently and issues associated with 7 the new assessment and oversight process. 8 MR. FERTEL: Thank you, Commissioner Merrifield. 9 I think that both Bill Travers and Mike Weber represented 10 the discussion that we had with them during the drop-in 11 yesterday very accurately. 12 I think everybody is looking to work together to 13 address all of the various activities that are ongoing and I 14 think that Mike did a nice job of saying the burden on the 15 individual licensee facilities, and the people in this room 16 are the people that are responsible for safety at 17 facilities, and they've been here now for three days, not at 18 their facilities, and they are committed to doing this and, 19 of course, it's the right thing to do. 20 We need to figure out how we plan all of the 21 various activities in sort of an efficient way so that the 22 industry resources, the NRC staff resources can be best 23 applied, and I think that the staff is fully cognizant and 24 wanting to do that and will do that. 25 I think on the oversight process, I appreciate 79 1 what Carl said about that. I do think that we basically 2 were running down the road with the template being the 3 reactor program. Some of it may be very much applicable. 4 It's just not clear it's all as applicable and I think 5 taking a step back, as Bill Travers said, I think will 6 benefit all parties involved. 7 So I'm very pleased. 8 CHAIRMAN MESERVE: I have just a few questions. 9 Mr. Fertel, when you were talking about the implementation 10 schedule, approval is obviously key to the ISA summaries, 11 and you implemented there are broader implementation issues. 12 Do you envision that that requires us to change 13 the proposed rule we have in front of us? 14 MR. FERTEL: No, sir. I think it's just us 15 working individually with the staff and the individual 16 licensees and coming up with a good integrated picture of 17 all this stuff. We don't see any change in the rule. 18 CHAIRMAN MESERVE: On this issue about approving 19 the integrated safety assessment, in your statement, as I 20 understood it, you thought that should be done in the 21 context of the licensing action, either the initial license 22 application or license amendment. 23 It seems to me that that makes the approval or the 24 re-review dependent on when a -- getting this ISA review, it 25 would then depend on when there was an amendment 80 1 application. 2 It seems to me your scope questions, that the ISA 3 may cover and should cover probably a lot more things than 4 just the subject matter of the license amendment. 5 MR. FERTEL: This subject is getting really tough 6 to deal with. I've got this simplistic view, which I think 7 I tried on Commissioner McGaffigan and it didn't work, which 8 is that on the initial ISAs, the ones that are being 9 prepared for compliance, it's really -- the way we're going 10 to demonstrate compliance or a major part of the way we're 11 demonstrating compliance with performance requirements in 12 subpart (h) will be the ISAs that get submitted, and NRC 13 will have to make a determination to allow me to keep 14 operating, that I'm in compliance. 15 Now, the way I think it's being thought of now is 16 I approve the ISA and I'm in compliance and -- 17 CHAIRMAN MESERVE: That's okay. 18 MR. FERTEL: -- that's okay. What I'm actually 19 saying, and maybe there's another way to skin this cat, and 20 maybe it's the only way we can skin the cat, is that I'm 21 saying when I think I'm asking for a decision by the 22 Commission that I am in compliance, I would ask for -- I 23 would submit my ISA. 24 The ISA would support my request for a decision 25 that I'm in compliance and the licensing action wouldn't 81 1 really be approval of the ISA. The licensing action would 2 be you're in compliance with the rule, it's okay, keep 3 going, and, in effect, you're approving the ISA. 4 I think, again, it could be -- and when we talked 5 to the staff, they said, well, you only approve -- we only 6 think the ISA gets approved once. That's not clear from the 7 rule. So that may be another way of looking at this. 8 If what I'm saying doesn't make sense to you all 9 in regulatory space, then an approval of the ISA is the only 10 way to do it, I think the staff would agree and they may 11 want to do something, but they only expect one approval. 12 Now, it may be 14 ISAs they're approving once 13 individually, but we were reading it that they're constantly 14 approving ISAs and we didn't think that was a good idea. 15 So I had the simple view of you're doing the 16 licensing compliance -- 17 COMMISSIONER McGAFFIGAN: Heads are shaking 18 negatively here, so that they don't intend to approve more 19 than once. 20 MR. FERTEL: That's what we were told last night. 21 COMMISSIONER McGAFFIGAN: Okay. 22 CHAIRMAN MESERVE: And that's acceptable. 23 MR. FERTEL: Yes. If we can't do it any other 24 way, I think that we could live with that, if that was 25 clarified. 82 1 CHAIRMAN MESERVE: Commissioner Dicus. 2 COMMISSIONER DICUS: Actually, being down the line 3 and asking questions, the Chairman and Commissioner 4 Merrifield asked my questions for me and I appreciate that. 5 CHAIRMAN MESERVE: Sorry. 6 COMMISSIONER DICUS: That's fine. It made it 7 easy. I did have a question on this implementation of the 8 rule, because that was sort of new to me, doing it on a per 9 licensee basis. 10 And, also, because you got to listen to my 11 questions to the staff, you answered mine as you were giving 12 your talk. So the short of the issue is I have no 13 questions. 14 CHAIRMAN MESERVE: Thank you. 15 COMMISSIONER DIAZ: That sounds just about where I 16 am. 17 CHAIRMAN MESERVE: Commissioner Diaz. 18 COMMISSIONER DIAZ: However, let me go back to 19 this word of substantial and/or significant and how it might 20 even apply to what is reported, how we apply backfit and so 21 forth. And I don't think there's any problem with those 22 things that have minimal cost and might have some added 23 safety are probably the more substantial issues. 24 So let me put our counsel to work in here. When 25 we actually put wording and looking at the history of how we 83 1 put rules, can we actually put a rule out there knowing that 2 we have a backfit rule that does not have the word 3 substantial or significant in it? 4 MS. CYR: I don't have the language right in front 5 of me, but I think right now it's a cost-benefit test. It 6 doesn't have substantial additional protection. The reactor 7 one, you have to define that it would provide substantial 8 additional protection and then you'd do a cost-benefit 9 analysis. 10 This one is you're basically looking at whether 11 the benefits outweigh the costs in providing additional 12 protection. So in a sense, it is a less strict test in the 13 agency in making the determination. 14 Now, what constitutes substantial additional 15 protection in reactor space has been similar that's been 16 developed over time in terms of our experience, in terms of 17 producing guidance out, because we've used not just 18 quantitative, but qualitative judgments about reaching that 19 determination in the ways we've looked at that. 20 So you wouldn't have that additional kind of test 21 that you would look at in terms of making a determination of 22 whether a backfit was appropriate. 23 COMMISSIONER DIAZ: Well, the interplay of the 24 words, of course, you add the word significant or 25 substantial, you're actually raising the level. Is that 84 1 more consistent with the way we have used the backfit rule 2 in the past? 3 MS. CYR: The language would be similar to what 4 you would have used in previous rules and with respect to 5 51.09 and I think 76.76 also uses the word substantial. 6 MR. FERTEL: Substantial in 76.76, significant in 7 51.09. 8 COMMISSIONER DIAZ: So that the use of the wording 9 itself essentially provides backfit protection at that 10 point. 11 MS. CYR: Right. It's trying to define, in a 12 qualitative way in the regulation, what that additional of 13 protection is that you're looking for. 14 COMMISSIONER DIAZ: And have we used the word also 15 to limit reporting requirements? Do we use anything that 16 says anything that is significant, like items relied on for 17 safety, it might very well be that we have used in the past. 18 I'm not sure. I'm just fishing. 19 MS. CYR: All right. I don't think we've done 20 that, but I can't say for certain. We can check that and 21 get back to you if we find circumstances where we've used 22 that kind of adjective to describe it. 23 COMMISSIONER DIAZ: Because there is another in 24 here, there is a substantial change in an item relied on for 25 safety, you might have to -- and then limit those who are 85 1 not really substantial to the yearly report. 2 I'm just thinking that there might be an interplay 3 in there that might limit it and still allow us to have the 4 information that is really needed on a more timely basis. 5 That's all, Mr. Chairman. Thank you. 6 CHAIRMAN MESERVE: Thank you very much. I think 7 we've reached the end of this meeting. I would like to 8 express my appreciation to the staff and to the panel here 9 from Nuclear Energy Institute for a very helpful 10 presentation on this rule. I would also like to commend 11 both the NEI and the staff for the very substantial progress 12 that they've made in trying to resolve a large number of 13 issues and bring this as close to final resolution as they 14 have. It's a very important activity and I'm pleased that 15 it's happened. 16 Let me turn to my colleagues and see if they have 17 any closing statements. 18 COMMISSIONER MERRIFIELD: I just want to make one 19 statement. I think the degree to which we're all grasping 20 to ask questions today is reflective of the fact that there 21 are a few issues that divide us and I think that's certainly 22 -- I agree with the Chairman, that speaks to a lot of hard 23 work. 24 I also was struck, as I was listening today, we 25 sometimes forget, I think we are somewhat unique as a 86 1 Federal agency in the fact that we can sit across the table 2 with our staff and with those who we regulate and try to 3 come to grips and try to resolve issues where we can enhance 4 our level of safety and, at the same time, do it in a manner 5 which is sensitive to a variety of concerns. 6 I think it was a good meeting today. Thank you, 7 Mr. Chairman. 8 CHAIRMAN MESERVE: Thank you. With that, we're 9 adjourned. 10 [Whereupon, at 11:25 a.m., the briefing was 11 concluded.] 12 13 14 15 16 17 18 19 20 21 22 23 24 25