ML20134K116
| ML20134K116 | |
| Person / Time | |
|---|---|
| Issue date: | 11/07/1996 |
| From: | NRC |
| To: | |
| References | |
| DSI-G-3-00010, DSI-G-3-10, NUDOCS 9611180253 | |
| Download: ML20134K116 (240) | |
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1 Official Transcript of Proceedings ])SE 6 3 4i3D l
- NUCLEAR REGULATORY COMMISSION i
i
Title:
Stakeholders Public Meeting )
Building Public Trust and Confidence i 2 J !
N 4 r i g REmvE0 s i
Docket Number: (not applicable) 3 Nov 141996 $
i the m)
Of Y
\
% l 8 .
! Location: Rosemont, Illinois ,
! 3>
l Date: Thursday, November 7,1996 F '
i, i l
! Work Order No.: NRC-902 Pages 1-242 i
I NEAL R. GROSS AND CO., INC.
- Court Reporters and Transcribers pj 1323 Rhode Island Avenue, N.W. I
, Washington, D.C. 20005 i 180059 (202) 234-4433 i j6y11go g 961107 GEN PDR W3 l
1 1 UNITED STATES OF AMERICA j 2 +++++
3 NUCLEAR REGULATORY COMMISSION 4 +++++ ]
5 STRATEGIC ASSESSMENT REBASELINING INITIATIVE 6 AND l
7 STAKEHOLDERS PUBLIC MEETING 8 +++++
9 BUILDING PUBLIC TRUST AND CONFIDENCE 10 +++++
11 THURSDAY 12 NOVEMBER 7, 1996 13 +++++ ]
14 ROSEMONT, ILLINOIS
-15 +++++
16 The Building Public Trust and Confidence 1,. Session met at The Ramada Hotel-O' Hare, 6600 North 18 Mannheim Road, at 8:00 a.m., Francis X. Cameron and 19 Douglas Brookman, presiding.
I 20 !
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2 1 PRESENT:
2 Kenneth Ainger, Commonwealth Edison 3 Kathy Allen, Illinois Dept. of Nuclear Safety 4 Gordon Appel, Illinois Dept. of Nuclear Safety 5 Douglas Beutel, Commonwealth Edison 6 Mark Burtschi, IBEX Engineering, Inc.
7 Mary Clarke, Washington University 8 Robin Colglazier, Commonwealth Edison, Byron 9 Stephen Collins, Ill. Dept. of Nuclear 10 Safety /OAS 11 Mark Doruff, Amersham Corporation 12 Joseph Drago, Commonwealth Edison 13 Paul Eastvold, Illinois Dept. of Nuclear 14 Safety 15 Ed Edgerton, NDTMA 16 Stephen England, Illinois Dept. of Nuclear 17 Safety 18 Kristin Erickson, Michigan State University 19 Paul Farron, Wisconsin Electric Power Company 20 Stephen Floyd, Nuclear Energy Institute 21 Ronald Fraass, Kansas Dept. of Health 22 Linda Fraass, First Lutheran Church 23 Robert Goff, IBEX Engineering, Inc.
24 Peter Holland, Commonwealth Edison 25 Roger Houston, Nuclear Energy Institute NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 1- PRESENT: (CONTINUED) l j 2 Irene Johnson, Commonwealth Edison 4
t j 3 Narinder Kaushal, Commonwealth Edison i
4-4 William Litschgi, Monsanto 5 T. Derrick Mercurio, Southern California 2 6 Edison ;
- 7 George Oliver, St. Luke's Hospital j 8 Harold Pontious, Jr., Commonwealth Edison r
9 Frank Popp, Univ. of Missouri / Kansas .
j 10 Reginald Ronningen, Michigan State Univ., NSCL i
j 11 Cheryl Schultz, William Beaumont Hospital
- 12 Victor Sgobba, USGAO 13 David Swank, Washington Public Power 14 Robert Sweeney, IBEX Engineering, Inc.
15 Tom Tipton, Nuclear Energy Institute 16 Mary Vincent, Commonwealth Edison 4
! 17 Robert Wagner, Loyola University Medical i
18 Center 19 Gerhard Wald, Commonwealth Edison 20 Heather Westra, Prairie Island Indian l 21 Community i
22 James Williams, Ohio Emergency Management 23 Agency 24 Ronald Wittschen, Detroit Edison 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE IS',AND AVE., N.W.
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i: l 1 A-G-E-N-D-A i
- 2 AGENDA ITEM _ Pf.gg.
I 3 Welcome & Opening Remarks 4 by Chip Cameron 5 5 Overview & Status Briefing 11
-6 Public Communication Initiatives 31 7 Role of Industry 69 i 8 Enhancing Regulatory Excellence 100 9 Oversight of the Department of Energy 134 10 NRC's Relationship with Agreement States 157 11 Materials / Medical _ Oversight 190 12 13 14 j 15 16-17 18 19 l
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5 i 1 P-R-O-C-E-E-D-I-N-G-S 2 (8:26 a.m.)
l' 3 MR. CAMERON: Good morning, everyone. My name 4 is Chip Cameron and I'm the Special Counsel for public
! 5 liaison at the Nuclear Regulatory Commission and my
?
6 colleague and I, Doug Brookman, right over herc, from 7 Brookman, King Associates, are going to serve as your 8 facilitators for the next few days and we'd like to 9 welcome you to the third and final Stakeholders Meeting 10 that the NRC is holding on the NRC Strategic Assessment 11 and Rebaselining Process.
- 12 And the purpose of the meeting is for us to
- 13 have an opportunity, first of all, describe the Strategic 14 Assessment Process to all of you and to answer any l
' )
15 questions that you might have on it. But, most l 16 importantly, to discuss your views on the Strategic Issues i
17 Papers that we're going to be presenting over the next two i
18 days.
i 19 And over the next two days, we're going to 1 l 20 have a unique opportunity, I believe, to. converse with i 21 each other on some of the most fundamental issues that are 22 facing the Commission on the use of nuclear materials and 23 I want to encourage as much interaction as possible 24 between all of you, including the NRC staff, on the 25 strategic issues.
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6 1 The value of the public meeting is, of course, 2 not only to hear your positions on the issues, your 3 recommendations on the issues, but also to take advantage j 1
l 4 of the opportunity for all of us to talk with one another 5 about the issues and, hopefully, for all of us to learn 6 from on another. I I
1 7 One of the important values, another important l l
8 value of the meetings and the discussion is this is really 9 a good opportunity to take advantage of what you hear in 10 formulating your written comments for the Commission later 11 on in the process. Often, it's good to think about what l 12 people are saying and to try to anticipate those things in 13 your written comments.
14 Now, Doug and I are going to endeavor to 15 assist you in having an active and informative session, 16 but ultimately this all depends on you and, again, I would 17 encourage you to say what's on your mind and to ,
i I
18 participate in the discussion.
19 Now, the NRC staff looks forward to hearing l I
20 your ideas and, as you will hear more about in a moment i
21 from our first panel, the staff is going to document all l 22 the comments that we receive here today, as well as the 23 written comments, and they're going to present that to the 24 Commission for the Commission's use in its decision making 25 on some of the strategic issues. I l
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7 s
1 This always reminds me of something that Woody 2 Allen said that I think might put this in a little bit of 3 perspective. He said that more than any other time in 4
4 history mankind faces a crossroads, one path leads to l.
5 despair and hopelessness, the other to total extinction.
6 Let us pray that we have the wisdom to choose correctly.
l 7 So'I thought I'd put this in perspective for you, but it's I i
8 not that bad.
9 I wanted to suggest a counle of guidelines for 10 the meeting. One is after the NRC staff makes its 11 presentation on a particular issue, I'll go out to all of 12 you for comment and discussion. If you want to say
. 13 something, please raise your hand and Doug or I will 14 recognize you and please either go to one of the mikes 15 over here or we do have a hand held mike that we'll be.
16- going through the audience with.
- 17 State your name and, if appropriate, your 18 affiliation and this is particularly important for l
19 purposes of the transcription of the meeting. We are l 20 taking a transcript of the meeting and those transcripts l
1 21 will be available for people to look at.
22 We do want to hear everything that you have to ,
23 say and, again, to make sure that we have everything on 24 the record, I would just request that only one person .
25 speak at a time.
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! 8 1 We don't have unlimited time. We do have, I t'.; ink, a small enough audience and there will be some more
~
i 2 l
l 3 people joining us, but I don't'think we should have a time 4 problem, but if we'do in any particular session, I may f I
j 5 have to ask you to quickly sum up your comment so that we I
L 6 can give another person the opportunity to speak.
i 7 .Try to be constructive. I challenge you to
! 8. not only give us your critique of the various issues l 9 papers, but also to suggest solutions and along these j l
10 lines, keep in mind that one of the key factors here in l 11 the Strategic Assessment Process is how the Commission can ;
l l 12 perform effectively in times of diminishing resources.
13 So if you're talking about a particular option 14 or if you have a suggestion, you might also want to keep 15 that in mind, the diminishing resource concept and also 16 another thing to pay attention to is that when you hear'a 17 strategic issues paper, there will be a number of options 18 presented and what the staff and the Commission is doing ;
19 is trying to select the best option and to look at the 20 trade offs between those options on a particular strategic 21 issue.
22 But another important point here is there are 23 trade offs between each strategic issue area. So that's l 24 another thing that I would ask you to pay attention to.
l f 25 There may be something that you think should be done in i
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1 l
1 the reactor area that may have consequences in another 2 area of the Commission's activities.
3 In terms of the agenda, I'll just briefly run 4 over the agenda for you and we're going to start out with l
5 an opening session that will describe the Strategic 1
6 Assessment Process for you and after that opening session, 1
7 after we have comment and discussion from all of you, 8 we're going to move into the second session of this 9 morning, Looking at the Strategic Arena of Building Public 10 Trust and Confidence and we'll go through each of the 11 three papers in that session and we'll have comment after 12 each of those papers.
13 We're going to break for lunch and then we're 14 going to come back for two concurrent sessions, at least 15 we're pretty sure we're going to have concurrent sessions 16 at this point, but the first one is on the Strategic Arena 17 of the Safe Use and Handling of Nuclear Materials and that 18 will be in this room, I believe. The second concurrent 19 eession that's going to look at the Commission's Research 20 Program and also the International Program is going to be 21 next door.
22 And after we're through with those two 23 concurrent sessions, that will end today. We will be back
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10 1 Operation of Nuclear Reactors. Then we're going to break 2 for lunch and then we'll go to two concurrent sessions l 3 again, one on Safe Management of Nuclear Waste and one on l I
i 4 NRC Finances, the NRC Fee Program. After those two l
5 sessions, we'll come back here for a brief wrap-up. l l
6 And before we go to the first panel for today, I 7 does anybody have any questions on the process, the ground 8 rules, the agenda?
9 Okay, good, well I look forward to a real good 10 discussion with all of you and the first panel, we're 11 going to have all three of these papers and then go to you 12 for questions, but the first presenter is going to be Jim 13 Milhoan who is Deputy Executive Director for Operations at 14 the NRC and he's also the Co-Chair of the Commission's 15 Strategic Assessment Steering Committee and he'll be i l
16 describing the Strategic Assessment Process, 17 Next, we'll go to John Craig from our office 18 of Nuclear Regulatory Research. John is the Manager of 19 Phase Two of the Strategic Assessment Process and that's 20 the phase that includes all of the public meetings and 21 documentation of comments for the Commission.
22 Our final panelist will be Jesse Funches who 23 is Deputy Director of the Controller's Office at the NRC.
24 Jesse is going to talk about the outcome of all of this; 25 Phase Three, the preparation of the Strategic Plan.
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- 1" So let's hear from all of them and then we'll I a
e i
!' 2 go back out to you for discussion.
} 3 Jim.
1 i
- 4 MR. MILHOAN
- Thank you, Chip, and I do 5 welcome you to the Chicago Meeting. As Chip said, this~is
_6 the third meeting and the last in the series of public: i i .
A
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- - 7 meetings we've had. We've had one in' Washington, and last !
i .
8 week we were in Colorado Springs. So we're here in ,
9 Chicago and I do appreciate your attendance and certainly ;
i 10 the'value of the meeting will be dependent upon your :
11 participation. We've had excellent participation in the 12 other meetings and I' expect the same that we'll have these j
13 two days. I 14 The environment in which the NRC conducts its i 15 activities is rapidly changing as a result of many l 16 influences. These include resource constraints, changes -
17 in the' industry that the NRC regulates and the potential' 18 for new and revised mission requirements.
19 Also, in order to accomplish regulatory 20 effectiveness, the agency must continually reassess 21 changing technology, accumulated safety experience and 22 improved assessment techniques for both the reactor and 23 the materials. program. Only by being prepared for the 24 challenges of a changing environment will the agency 25 continue to keep its health and safety mission in sharp NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W. ;
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12 1 focus.
2 With these challenges in mind, Chairman 3 Jackson established a Strategic Assessment and 4 Rebaselining Initiative. To oversee this activity, a 5 Strategic Assessment and Rebaselining Steering Committee 6 of senior agency members was formed. Members of the 7 committee, a large number of members of the committee are 8 present today. The committee members were made up of 9 Deputy or Office Directors of the major program offices in 10 the agency.
11 Jim Shea, also the Director of the Division of 12' Biolateral Cooperation Assistance in the office of 13 International Programs, also served as a sponsor for the 1
14 International Activities Issue Paper and you will hear '
i 15 that paper in a session today. j 16 The Steering Committee had a support group to l 17 help us in our carrying out our assessment and j 18 rebaselining activities and also was supported by a i
19 contractor, Public Strategies Group, Incorporated in 20 conducting our work and I'll be discussing here the work 21 that we had in the phases of the Strategic Assessment and 22 Rebaselining Process.
23 The Steering Committee is analyzing where the 24 NRC is today and developing options which the Commission 25 can use to determine the agency's future path. The effort NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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13 1 is divided into four broad phases that will be carried out
- 2 sequentially, with each of the phases building on the 1
3 preceding phase, j 4 The first phase, the Strategic Assessment 5 Phase began in August of 1995. The Steering Committee- 1
! 6 began with the bottom up approach for assessing where'the I
i 7 agency is today with the examination of current NRC f 8 functions and activities.
l
- 9 The Steering Committee requested the staff to 10 provide at the lowest organizational level each activity
] ]
- 1 1 11 presently being performed by the NRC, as well as its )
j 12 basis, in other words statute, regulations, Commission,
' l 13 guidance, what is the basis for the activity we're doing i
- 14 and also the request included the primary internal and i
15 external factors that are expected to affect the agency's 16 performance of the activity in the future.
17 The staff assessment included approximately 18 4500 activities, which the Steering Committee rev.ewed to 19 thoroughly understand what the agency is doing, why the 20 agency is doing it, and what factors must need to be 21 considered in providing options for change.
22 The Steering Committee organized the 23 activities by major function and lines of business. This 24 was done to consolidate similar activities and to render 25 the data organizationally neutral.
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14 1 Based on this information, the Steering 2 Committee applied a top down strategic -- to define issues
! 3 whose resolution will influence the future direction of 4 the agency.
1 5 After identifying the strategic issues, the 1
6 Steering Committee considered them in an integrated 7 fashion. First, the individual strategic issues were 8 arranged in logical groupings of related issues. The 9 groupings were then examined to determine if a predominant 10 issue existed within each group. These predominant issues 11 are referred to as directional setting issues, or DSI's, 12 because their resolution taken together would establish 13 NRC's strategic direction for the future.
14 Resolution of the DSI's will prov.de a 15 strategy for the agency to meet a strategic vision and 16 goal. DSI's were developed into decision papers which are 17 referred to as issue papers and which you have and were 18 made publicly available.
19 The second phase builds on the strategic 20 issues in the DSI's identified in Phase I. And as I 21 indicated earlier, included the development of the issue 22 papers. The issue p' apers are intended to provide broad 23 direction from the Commission.
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24 The issue papers include descriptions of the j 25 background of the issue and the external and internal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W.
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15 1 factors that the Commission may wish to be aware of when 2 considering options to resolution of the issues. The 3 issue papers also provide the Commission with policy i 4 options for the issues.
5 It should be noted that Chairman Jackson ,
6 encouraged the Steering Committee to develop innovative ,
7 options that are no constrained by existing practices or
-8 organizational structure. Additionally, in some issue 9 papers.certain options could be considered to be 10 extraordinary. '
11 While the Commission is unlikely to select 12 such options, these options have been retained in the 13 issue papers to illustrate to the NRC stakeholders the 14 breadth of options that were considered.
15 It should also be noted.that the Steering 16 Committee was not requested to provide or recommend a 17 preferred option, but we were responsible for assuring 18 issue papers contained a rich set of options.
19 It is anticipated that final Commission 20 decisions on the DSI's will result in a rebaselining or 21 resetting of the agency's goals, assumptions and 22 strategies. Final decisions on the issue papers will also 23 influence the related issues identified as part of the 24 assessment conducted during Phase I.
25 Feedback from the various NRC stakeholders NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS i 1323 RHODE ISLAND AVE., N.W.
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l 16 1 continues to be an important aspect of evaluating our 1
2 regulatory programs. The primary goals in acquiring l
l 3 stakeholder' comments are to obtain views for commission -
-4 consideration in reaching final decisions on'the issue 1
5 papers and to determine whether the agency has omitted any l 6 important considerations or issues.
l l 7 In Phase III, the Strategic Plan will be 1
8 developed from the agency's mission statement, its I
9 strategic vision, general goals and the Commission's 10 decision on the issue papers. The development of the 11'- Strategic Plan will be guided by the requirements 12 contained in the Government Performance and Results Act of 13 1993. The Strategic Plan will be the agency's tool for 14 resetting priorities and allocating resources consistent 15 with the vision and goals of the agency. l j
16 Phase IV is the Implementation Phase. The I
17 Implementation Phase includes implementing the 18 Commission's decisions based on the issue papers l
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19 generating Commission papers to resolve related strategic '
20 issues and complying with Commission guidance based on the 21 Strategic Plan.
22 The Implementation Phase will also include 23 developing a framework that allows for updating the 24 Strategic Plan and for integrating the Strategic Plan into 25 the budget process, performance monitoring and reporting NEAL R. GROSS CoORT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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. 1 processes and the process for development of future 2 Commission decisions. I h 3 i
4- At this time, John Craig, the Task Manager for l i
! 4 the Phase II and the later phases of this effort,'will be 5 discussing in more detail Phase II of this particular H l 6 project.
i 7 John.
q 8 MR. CRAIG: Good morning.
9 Phase II, as Jim mentioned, built upon the l
2 10~ work that had been done in Phase I and in February of '96, 11 writers and sponsors got together and we began to form 12 think tanks to discuss options associated with each one of 13 the issue papers. If you've had the opportunity to look i
14 at the issue papers or some of the slides for the 15 subsequent discussions for the next two days, you'll see a 16 number of options listed there.
l
- 17 We tried to identify options that we referred
! 18 to as out of the box and by doing that you can discuss 19 options that wouldn't constrain or limit the potential
- 20 innovative approaches to the direction setting issues.
21 Some of the options are a little extreme, some require j 22 legislation. The key was that the options were to be 23 discussed and described to present a range of possible 24 approaches to a direction setting issue without 25 considerations for resources, schedules, et cetera. It NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 was to really focus on a broad range of good options.
2 And as Chip mentioned earlier, we're at the l
- 3. stage where that presents some interesting questions 4 because the comments that we've gotten during the first j 5 two meetings, in general, are we should do more in a l ,
6 number of areas and only one or two areas where it was 7 suggested, .I think, that we do significantly less and in i
i 8 an era of reduced budgets and reduced staffing, that's i l ;
9 going to be a real challenge to us. !
10 The issue papers are available on the tables 11 outside in the hall, all 16 of them. We started off with 12 24 direction setting issues, and we developed the issue 13 papers and presented them to the Commission. Based upon 14 their review, they made some preliminary views on a number 15 of issue papers. They combined a few and a couple of 16 others they thought weren't either at a broad strategic I
17 level or were more appropriately addressed after decisions '
18 had been made on the other issue papers, and I'll go over l I
19 those in just a minute.
20 There are two other key documents associated 21 with the Strategic Assessment Initiative. The Strategic !
22 Planning Framework Document, and there are copies of both 23 the framework and the process paper out there also, 24 contains the mission, vision and goals and it has broken 25 up the issue papers in something called strategic arenas NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 and their related papers. So there's a strategic arena 2 for operating reactors.
3 There are a number of issue papers that cut 4 across strategic arenas, risk informed performance base, '
5 for example. So even though you'll see one issue paper 6 and-it will be discussed, and risk informed performance t i 7 base is a good example, where it will be discussed in the -
i 8 Operating Reactor. Program Strategic Arena, clearly risk
- 9 informed performance based activicies and decisions are l
l 10 going to affect the materials area also, i
11 The Stakeholder Involvement Process Paper is 12 just exactly what the title implies. It was intended to i 13 tell stakeholders, internal and external stakeholders, how j 14 to get copies of the documents and how to provide comments
. 15 and I'll pause for a minute just to tell you, I heard some 16 discussions about what a stakeholder is, and there are two 17 kinds. People that are internal NRC staff are l
18 stakeholders and then everybody else, the public, the j 19 industry, Congress, Oversight Committees, et cetera. So 20 the comment that I heard was that stakeholders somehow
.E 21 implied agreement with the views, et cetera, and that's 22 not the case. Rather it was a term that's used just to i
j 23 describe people that could have an interest in the i 24 activities that are under way.
25 Jim's already mentioned the importance of the NEAL R. GROSS
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1 stakeholder comments and I guess I would stress that this 2 is sort of a unique process whereby the Commission has had 3 the staff do a review, identify potential. options. The 4 Commission has indicated its preliminary views and now 5 we're seeking comments from the regulated industry, the l
public at large and the NRC staff, about various aspects 6
i 7 of those issues papers and the preliminary views.
8 There are four focus questions that you have 9 seen in the meeting announcement to help you provide 10 comments and help focus your comments and also, as Jim 11 mentioned, the next stage of this will be a review of the l
12 comments by the Steering Committee and a review and 13 consideration of the conments by the Commission as they 14 make final decisions on the issue paper and then these 15 decisions will be reflected in the Strategic Plan.
16 So in a very fundamental way, the comments 17 that we're requesting are going to be used and 18 incorporated to determine final decisions in the content 19 of the Strategic Plan.
20 Following the Commission's review of 24 issue 21 papers, as I said, we aow have 16 issue papers that are 22 part of the Strategic Assessment and Rebaselining 23 Initiative. DSI No. 1, which was Regulating Areas of 24 Little Public Risk, was combined with DSI 12, which is 25 Risk-Informed Performance-Based Regulation. DSI 3, which NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 was Dual Regulation of Other Federal Agencies, was 2 combined with DSI 7 and DSI 12. I'm not going to read the 3' titles to you. We're going to discuss L11 16 over the 4 next two days.
5 DSI No. 8, which was Regulating a Small Number 6 of Licensees was determined not to be at a strategic 1 7 level. It affected just a small group of licensees.
I 8 on the next slide you'll see a gap between 14 l l
9 and 20. These DSI's related to management philosophy, 10 information resource management and planning, management 11 and organization staffing and core capabilities and 2 12 independent oversight. They are internal activities for 13 the NRC and the thought is that a number of the decisions 14 in these are more appropriately addressed after decisions -
15 are made on the other 16 and so that's how they're being.
16 addressed.
17 There's a summary that's part of the framework 18 document that has the information I just presented and 19 it's, as I said, also on the table outside.
20 We've gone to some significant lengths over 21 the past few months to announce the availability of the 22 issue papers, the framework document and the process paper 23 to notify NRC staff and members of the public of the 24 meetings. We issued press released beginning in September 25 and in September and October we had individual mailings to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 about 1650 organisations and individuals that covered a 2 very broad spectrum of interests and we've had subsequent 1 3 press releases in the month of October.
l-4 We've also held meetings with the internal i
5 meetings. We've had a series of meetings and meetings L 6 have also been held, which were public, with the Advisory i
7 Committee on Reactor Safety, the Advisory Committee on 8 Nuclear Waste so that the oversight committees that look 9 at NRC staff activities also have been briefed on the 10 process.
11 And as Jim mentioned, this is the third of 12 three meetings with external stakeholders and the other 13 two meetings were in Washington and Colorado Springs.
14 What are we going to do with the comments?
15 The comment period is scheduled to close November the 16 15th. We're keeping lists of the comments. We have 17 indexes for each one of the comments that we've received.
18 They're available in the Public Document Rooms so that if 19 you wanted to know which comments had been received on a 20 specific issue paper, there's a summary listing of those 21 and all of those comments are also available.
22 The writers and the sponsors were going to 23 review and collate the comments. The comments, in 24 general, fall into two categories, the kind of comment 25 that goes directly to the DSI or the factors that were NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 considered, the option that was chosen by the Commission l 2 or comments that are more at an implementation level that 9
3 the staff should consider. We're going to try and sort
)
4 those a little bit and present the ones to the Commission
- 5 that are more central to the decision that they're about
- 6: to make as part of the final decision making on the issue 7 papers.
- 8 All of the comments are going to be 9 incorporated into a Stakeholder Interaction Report. So 2
10 both the broad comments and the implementation comments 11 will be available to the Commission. The Stakeholder 12 Interaction Report will be ava.ilable to members of the 13 public. It's going to be put on the Internet. It will i
14 also be available in the Public Document Rooms. j i
15 We've gone to some significant lengths to try l 16 and reach out and contact the various stakeholders who areI 17 interested in the process. We've gotten, I think, some 18 outstanding comments and insights on some of the options 19 and are being considered.
20 The next phase of the process, Jesse Funches 21 is going to describe, where he takes the results of the 22 hard work from Phase II and then I think the really hard 23 part of the Strategic Assessment Initiative will begin to 24 make the final decisions and then to actually implement it 25 for the next three to five years.
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l 24 l
i j 1 Jesse, j
2 MR. FUNCHES: One of the major outputs of the I 3 NRC Strategic Assessment and Rebaselining effort will be 4 an NRC Strategic Plan. This is also referred to as Phase 5 III of the Strategic Assessment and Rebaselining 6 Initiative.
7 The activity that John has described for 8 Phases I and II will provide the foundation for the NRC 9 Strategic Plan. The identification of issues, the issue 10 papers themselves, the Commission preliminary decisions, 11 the identification of internal and external factors during 1
12 Phase I will be used to develop the NRC Strategic Plan. l 13 Your comments today on those issue papers and 14 on those preliminary decisions by the Commission will also 15 be important input to the development of the plan.
16 The primary purpose of the NRC Strategic Plan 17 is to set the direction for the NRC for the next five to l 18 ten years. It's to respond to those external factors that l 19 Jim Milhoan mentioned as part of the introduction. In 20 addition, the Strategic Plan will meet the requirements of 21 the Government Performance and Results Act.
22 In summary, that Act requires us to do three 23 things. First, we are to develop a Strategic Plan whose 24 purpose is to guide the agency for the next five to ten 25 years. In addition, we are to develop an Annual NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 Performance Plan. This Annual Performance Plan will set 2 the annual goals and measures that we'll use for a 3 particular year. This Annual Performance Plan will be an 4 integral part of the budget in the future.
5 And, lastly, the Government Performance and 6 Results Act requires us to develop a Performance Report 7 that reports on the execution of the Performance Plan.
8 The Strategic Plan and the Performance Plan is 9 to be completed no later than September of 1997 and it is 10 to be used with the fiscal year 1999 budget. The 11 Performance Plan will report on the execution of the 12 fiscal year 1999 budget and, therefore, is required to be 13 produced in March of the year 2000.
14 We see our Strategic Plan as not being static.
15 We see it as being a quote living document. We will be 16 updating the plan from time to time and we envision some 17 type of review annually to make sure that the situation 18 that we are responding to has not changed or that the 19 strategies that we have developed are working and if 20 they're not working we will adjust them.
21 The last phase of the Strategic Assessment and 22 Rebaselining is implementation. One specific 23 implementation action that we know we will have to take is 24 to develop a budget that will be guided by the Strategic 25 Plan. There will be other implementation activities.
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26 1 Those will be specified as the Commission makes its 2 decision on issue papers, utilizing the results from the 3 stakeholders meetings.
4 I'd like to spend a few minutes talking about 5 what we envision the Strategic Plan to be and what it will 6 not be and I hope this'will give you some additional 7 guidelines to help you comment today on the issue papers.
8 We see the plan as being a relatively short ;
9 document on the order of about 30 or so pages. It will be 10 a guide for all levels of program decisions and resources .
1 i
11' decisions. We do not see it as specifying what those 12 resources will be. It will specify important agency level 13 goals and objectives. It will not provide individual 14 organization goals and objectives, however we would expect 15 it to guide those goals and objectives that specific 16 organizations within the-NRC might develop.
17 It would provide strategies for achieving the 18 agency goals and objectives and I think the Commission 19 preliminary decision and the issue papers plays a very 20 important role in developing those strategies. ,
21 And, as I mentioned earlier, it would be ;
22 updated periodically to reflect new information.
23 The budget will come later. Operating plans, 24 performance plans also will come later and other details u 4
25 for implementation will follow the plan.
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2 27 1 We have somewhat outlined what we envision the l 2. Strategic Plan to include. The five basic elements that
. 3 we see in tne plan would be a statement of NRC's mission, 4 basically the purpose for the NRC's existence; a graphic 5 picture of where NRC wants to be in the future, this will 4
6 be our vision. We will also have a section on values and .
7 principles specifying those beliefs that will guide the i
8 NRC employees in their work. We will have goals and l
l 9 objectives and we will have the strategies that define how 10 we will achieve ti.e mission vision and goals.
< 11- To articulate the strategies based on the i
4 12 initial work that has been done, we have organized the 13 plan around what we call Strategic Arenas and you will see 14 those today as we discuss the' issue papers. Baaed on what
! 15 we have done so far, we have identified three broad 16 categories. The first category is what will call Mission 17 Critical, second category is Mission Enabling and the last i
18 category is simply called Core Resources.
19 Within the Mission Critical, we have arenas on 1
20 reactor safety, material safety and waste. In Mission ;
21 Enabling we will have building public trust and 22 confidence, providing research expertise, supporting NRC 23 domestic and national responsibility in the international 24 arena and providing the necessary support to the Mission 25 Critical areas.
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l 28 1 We have three Core Resource strategic arenas. j 2 The'first one would be Human Resources. Another one is i 3 Financial Resources and the last one would be Other 1
)
4 Information Resources.
5 With that short introduction to our Strategic 6 Plan, that's all I have and I turn it back over to Chip. 1 l
7 MR. CAMERON: Thanks, Jesse. Let's go out to i I
8 the audience ir comment. You know, I might note that the
)
9 Strategic Assessment Rebaselining Process is not just 10 unique to the Nuclear Regulatory Commission. As several 11 of the panelists pointed out, all of the federal 12 government agencies are going to be doing this. The NRC 13 got a head start, but also private organizations, state 14 government,-local government organizations are also doing 15 this.
16 So if there's anybody who's been through this 17 type of process who wants to share any of their 18 experiences that may enlighten our process, I would 19 welcome you to-do that and in this regard, I should-20 introduce Steve Strothers in the back of the room, who's 21 with the Public Strategies Group. PSG is what we 22 affectionately call them, I guess, but they have an 23 expertise in helping public organizations do this type of 24 process. So Steve is with us today.
25 Any comments or queutions for the panelists?
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-_. . . . _ _ _ - . _ . _ _ _ _ _ _ . _ _ _ - _ _ - _ _ __ _ _ _ _ _ _ ~ . . . . . _ _ . _ . _ _
29 1 Kathy.
2' MS. ALLEN: I just have a question -- ,
I 3 MR. CAMERON: Hold.on a minute, let me get you 4
l 4 this mike and because we are transcribing, if I could just i 5 have everybody just state your name, affiliation and just {
6 speak into the microphone. .
7 MS.' ALLEN: Kathy Allen from the Illinois 8 Department of Nuclear Safety. !
l l
9 I have a question about stakeholder comments.
10 I notice on your Internet Home Page or on your Internet 11 Page that you have a place where you can click to review l l
12 the comments and it's been.about a week since I've been on l
13 and I haven't seen any. Are there any plans to get those 14 on before the comment period ends?
l 15 MR. CRAIG: We're in the process of putting I
16 transcripts from the meetings we've held up on the j 17 Internet even as we speak. We hadn't planned to put the 18 comments _up on the Internet as they come in, rather we j 19 were going to put them up as part of the Stakeholder
! 20 Interaction Report.
- 21. MS. ALLEN: Do you think that they will be 22 available December 6'th or.will there be a lag time on the 23 Internet?
l i 24 MR. CRAIG: There will be a little bit of a 1
e l
25 lag time just because of the process of giving the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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i I
30 '
I computer people the documents to get it up on the 2 Internet. We're going to try to make it as short as 3 possible.
4 MR. CAMERON: Thanks, John. Any other 5 questions out here or comments on the Strategic Assessment 6 Process or the public comment process?
7 Okay, it turr,3 out that this usually is the 8 clearest point of the two days. So let's take a little 9 bit of a break to give Bob Perch time to, Bob is up here.
10 He's Strategic Assessment Staff. He's going to get the i
11 handouts for the presentations in the next session, put 12 them in the back of the room for you and we will have 13 handouts for every session. If you need copies of the i
14 paper, they're outside, I believe, by the registration 15 desk, all of the Strategic Assessment materials. ;
16 So let's take a quick break until 20 after
)
l 17 9:00. We'll start promptly then. That still puts us on 18 schedule and we'll get the handouts for you.
I 19 (Whereupon, a short break was taken.)
20 MR. CAMERON: If everybody could begin to take 21 their seats. We're going to get started here very 22 shortly.
l 23 .Okay, we're going to get started on the first j 24 Strategic Arena for discussion this morning, and that 25 includes three issues papers. The first is Publ2c NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 l 1 Communication Initiatives and we have Steve Crockett from 2 our Office of General Counsel who is going to present that 3 paper. We'll then have discussion on that.
4 Next, we'have Stu Rubin who is from our Office l
5 of Analysis and Evaluation of Operational Data, who is 6 going to present the Role of Industry Paper. We'll then 7 have discussion. !
l 8 Then we'll go to the final paper of the j 9 morning, Enhancing Regulatory Excellence, and Stu Rubin is 1
10 also going to present that paper.
11 I'll ask Steve Crockett to come up now and 12 present the Public Communications Paper.
13 MR. CROCKETT: Thank you, Chip. Can everybody 14 hear me? If there's anybody out there who cannot hear me, 15 please raise your hand. I see no hands, good.
16 I'm not either of the people named up there. ,
- - 17 Karen Cyr, our General Counsel, is headed for South Africa 1
18 right now to participate in discussions on an 19 International Treaty on Nuclear Waste and Roger Davis is j 20 in a Corssioner's office at the moment and so I'm 21 picking up where Roger left off and I'm very pleased to be 22 able to do so. This is an extremely important subject.
23 I might add that although Karen is a lawyer, 24 Roger is a lawyer and I'm a lawyer, this is not a legal 25 subject. It's much broader than anything the law provides r
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32 1 for and the kinds of options that I'm going to present to 2 you this morning, are not options that require any changes 3 in the law.
- 4 The various issues papers have received some l
5 criticism for not being as clear as their readers would ,
6 like. This was one.of the papers that came in for such
' 7 criticism. I will try to be as clear as I can this i
- 8 morning.
9 I will be covering the direction setting issue i i 10 itself, why it arises, some of the key factors that will l
11 affect the Commission's decision on this issue, the i ,
12 options that the writer presented the Commissioners with l 13 and also the Commission's preliminary views.
14 Could I have the second slide, please? Oh, l 15 it's up there, good, thank you.
16 Here are the three key factors which will J
17 affect the Commission's decision. The NRC already has a i 18 very strong program of public communications and I'm going 19 to outline that program for you later and b ve you some 20 rather striking numbers. 'However, there are some factors, 21 both legal and technological and social which suggest new 22 opportunities. The third key factor is that the NRC has
'23 already undertaken in recent years several key initiatives 24 in the area of communication with the public.
25 Let's look now at key factor number one. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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- 33 1 NRC has a policy which favors broad public disclosure of 2 information'and broad public involvement. Our principles e
3 of good regulation state that we should make our 4 activities publicly known, that we should be candid about 5 what we're doing and we should try to make our regulations i
]
l 6 as clear as possible. 0 7 We have two-policies in place already dealing j
l 8 with public communication. Both of these came out last l
9 year. One is a policy on responsiveness to the public, 1
10 the other is a policy on access to information about the l l
- 11 agency's programs and activities, j i
- 12 Both-of these policies are commitment, that is 13 both of these policies are very amply demonstrated by 14 several of the things that you see listed under the second i
g 15 bullet up there. We have a huge Public Document Room in 16 Washington D.C. and over 80 Public Document Rooms around u
1 17 the country. The Public Document Room in D.C. has over 18 two million documents and a few hundred are added every i 4.
. 19 day to the list. We are making increasing use of the l
) 20 Internet. In fact, the bulletin board that we have at Fed j 21 World is second only to the IRS in the number of hits, and 22 I hope somebody will explain that to me, why only the IRS ;
- l
$ 23 comes ahead of us.
. 24 Much of our business is published in the 3
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34 1 increasingly available over the Internet. We have a very 2 large office acting under the Freedom of Information Act 3 which is sort of the grandparent of all our access to 4 information activities.
5 The Office of Public Affairs is 6 extraordinarily active in the area of public i
7 communications. They have 14 full time people. They have 8 people out in the regions. They publish pamphlets. They 9 have a very good Web site; I urge you to visit that Web i
10 site. They've received some 12,000 calls a year from 11 representatives of the media. I did a little calculation; 12 that turns out to be a call from a journalist about every 13 ten minutes every working day of the year.
14 Congressional Affairs serves a similar 15 function for Congress. We are under a statutory 16 obligation to keep Congress fully informed and 17 Congressional Affairs is very active in that area.
18 Finally, Chip Cameron operates OGC's public 19 liaison function, a function which has been 20 extraordinarily important in recent years, especially in 21 our, what we call the enhanced participatory rule making I 22 on decommissioning and decontamination.
23 Let's look at key factor number two, the 1 24 developments that are suggesting new opportunities.
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35 1 and material coming out of the White House which promote 2 new technologies and new standards to be applied in the 3 use of that technology. We had a revision to the 4 Paperwork Reduction Act. We have new circulars from the 5 Office of Management and Budget. We are being told and 6 sensibly told that we should try to make as much 7 information available in as equitable a manner, in as l 8 timely a manner as possible and on a cost beneficial ,
t 9 basis. I'll say more about cost.and benefits later.
10 The second item under this key factor, there 11 was also new super fund legislation this last year,-which 12 although it does not apply to us, will certainly make much ;
13 more popular the idea of community resource boards in the
'l 14 area around sites which are covered by super fund. We can 15 expect pressures to increase on us to devise similar 16 techniques for communicating with the public. I 17 Decommissioning is now on the horizon for 18 several of our licensees. This will increase the need to
'a- communicate with the public whenever we have a major rule 20 making, such as the decommissioning and decontamination 21 rule-making we need to get out there early and find out l
l 22 what the public concerns are.
)
23 The last item is developing very rapidly as we 24 speak. There are all kinds of new economic challenges 25 facing the industry. I recently attended an energy daily NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 conference on the increased competition in the industry. ,
2 The industry-faces those challenges. The NRC faces the i 3 challenge of figuring out how to regulate the industry in 4 these new economic circumstances. And as we change 5 policies, as we try to deal with this new situation, we 6 need to be able to get out there and explain what we're 7 doing.
8 Let's take a look at the third key factor.
9 The NRC has been active in recent years inventing new ways 10 to deal with old difficulties. As I mentioned before, 11 we've had the enhanced participatory rule making on 12 decommissioning and decontamination. We just finished up
- 13 a pilot project conducting the activity preliminary to a '
14 rule making on the Internet.
15 We call it Rule Net. It allows for people to 16 comment on the prospective issues in a rule making well 17 before any proposed rule goes out. It also allows people, l 18 and I think this is extremely important, it allows i
19 commentors to talk to each other. Usually, the comments l 20 are, the way America On Line is wired, everything goes 21 through a central location. It's not really a network, 22 but Rule Net is really quite different and people were l 23 able to converse with each other, as well as with staff 24 members. Staff members were able to converse with the 25 commentors outside of the formal procedures of Federal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37
]
l 1- Register notices and the like.
i 2 For the last two or three years, we have been
! 3 conducting open enforcement conferences; about one in four 4 of our enforcement conferences has been open. This is a j 5 policy not without some controversy surrounding it, but it !
l 6 has been an effort that we're taking stock of now and we
- 7 will see what course the Commission takes on it.
8 Finally, I'm going to skip over the NRC 9 Citizen's Guide and mention something that's not up here. '
10 We took great pains to revise our, what we call the 2206 11 Petition Process. Under 10CFR Section 2206, any citizen 12 can petition the agency for some enforcement action or 13 other useful action involving a particular licensee. The 14 process has had some revisions to it recently. We now 15 provide a limited opportunity for a legislative style 16 hearing. We make sure that there is one person on the 17 staff who is assigned as the contact for the petitioner 18 and we are much more regular in putting out status reports 19 on these petitions.
20 Let's move now to the options that Karen Cyr 21 and Roger Davis presented to the Commissioners.
22 There are fundamentally three options here, 23 but they are not mutually exclusive and, indeed, you could 24 say we are in some way or another pursuing all three 25 options right now. Our decommissioning and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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38 l 1 decontamination rule making, for instance, is certainly a 1
2 case of putting a priority on early identification of I 3 public concerns and methods for public interaction.
4 Anybody familiar with the work of the Office of Public !
5 Affairs knows how much effort they put in to general 6 public outreach, making pamphlets available, making even i
7 such things as -- reports available at OPA's Web site, but 8 we have separated these into three options, nonetheless, 9 and we've put the emphasis here on priority.
10 It's not that if we adopted option one we 11 would never set about seeking early identification of 12 pu. c concerns. It's not that we would not try to have 13 good general public outreach, but if we were to adopt 14 option two, we would place a priority on that. We would ;
I 15 be more systematic about it. We would expand it. We 1
16 would devote more resources to it.
l 17 I should say also that option one is by no 18 means in status quo. It's a constantly changing activity, 19 so it's not stable, it's not sitting still.
20 Let me begin now to describe these options in 21 more detail very briefly. The existing approach consists 22 mainly of dissemination of a huge amount of information 23 and response to public comments and inquiries about that 24 information. It's not a centrally organized approach.
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39 1 inefficiency in it. It may be that one office is 2 duplicating activities that another office is carrying 3 out.
4 From the standpoint of an interested member of 5 the public, that's not so bad, that inefficiency is not so l
6 bad because it means that you have many opportunities to ,
l 7 find out a single piece of information. But in an era-of l 8 declining budgets, I should have mentioned that as one of 9 the key factors affecting the Commission's decision on 10 this direction setting issue. In an era of declining 11 budgets, efficiency is something that the Commission just 12 must think more about.
13 Moreover under the existing approach, we may l 14 miss a good deal of information and ideas that we would i
15 get from members of the public. So it's good to think i 16 about other possibilities.
l 17 Now, there is a variation on this first option 18 and that is to focus more systematically on maximizing 19 effectiveness in economy. Now, this phrase, effectiveness 20 in economy is a phrase borrowed from some of the new 21 legislation that I spoke of earlier, some of the new 22 material coming out'of the office of Management and 23 Budget. It asks us to think more consistently and 24 systematically about whether the methods of public 25 communication we're using are really effective and,
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40 1 moreover, whether they are the cheapest ways, the least 2 expensive ways to achieve those same effects.
3 If we were to adopt this inset option, this 4 focus on maximizing effectiveness in economy, we would set 5 about a more wide ranging and systematic cost benefit 6 analysis. We would develop a plan. We would then assess 7 each of the elements in our public communications program 8 to see whether it's the best possible. ,
9 As I've just described it, I think it's 10 obvious that this would be a costly venture and for that 11 reason, you'll see a slight variation on this option in 12 the Commission's preliminary view. l 13 The second main option, placing a priority on 14 early identification of public concerns would have us put 15 a priority on doing more things like we do in the 16 decommissioning and decontamination rule making. We would 17 train more people to carry out the kind of function that 18 Chip carries out so well. We would work with our 19 technical people to develop ways to communicate 20 complicated technical subjects to the public. I think we 21 have some reason to see from the so called popular science 22 literature tha.t that occasionally works and there are ways 23 to do that and people can be trained to do that.
24 That, too, just like the focus on maximizing 25 effectiveness in economy is going to carry some costs, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 41 l l
1 principally the costs of training, but we also know that j 2 there are many costs of not taking such efforts and those l
l 3 of you who lived through our difficulties with what we 1
1 4 called our below regulatory concern policy statement back 5 in the late eighties will know that our not getting out ,
I 6 early on that to find out what the concerns of the public l
7 were cost us a great deal. In fact, the policy statement 8 was simply wiped off the books by legislation in, I think, 9 1992.
l 10 The last option that was presented to the 11 Commission was an option which would place priority on 12 expanding the kind of thing that the Office of Public l l
13 Affairs already does. The Office of Public Affairs would l l
14 therefore have a much larger role. It would take an even 15 more active role than it does already in describing the 16 agency's program, the agency's philosophy. The Office 17 would produce files, exhibits, say exhibits of things like 18 waste containers, tutorials, say tutorials on radiation 19 protection.
20 We would try to make sure that NRC 21 professionals have a greater visibility at professional 22 meetings and that kind of thing. That, too, would be a 23 costly effort. There are two other possible down sides to 24 this option also; one is that it might be viewed as 25 promotional. People might suddenly think that we were out NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 trying to generate friends for the atom and to reproduce 2 some of the booklets that the Atomic Energy Commission 3 reproduced in its hay day. I 4 There's also some concern that in the effort a
5 to explain technical questions to a larger public, we 6 might simplify them and therefore lose some of the key, in l
7 the public discussion, some of the key technical details 8 might be lost.
9 Let's move now to the Commission's preliminary 10 views. For the time being, they are taking the middle I 11 path and with the memory of our difficulties with the 12 below regulatory concern policy statement, they are
, 13 thinking that we should set a priority on early 14 identification of public concerns and methods for public 15 interaction. They urge the staff to view the word public 16 in its widest possible sense, to include all our 17 licensees, all levels of government that these other 18 federal agencies, the Congress, the Courts, state 19 governments and our international partners. It means 20 citizens who are interested for one reason or another in 21 our activities.
22 Each one of these segments of the public have 23 different needs, and the Commission urges the staff to 24 take these different needs into account.
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43 1 carefully at the role of technology. Many of us, myself 2 included, are fascinated by the possibilities of the I
3 Internet and I spend a good deal of time almost every day l 4 on the Internet looking for material that's useful in my l 5 work, but there aren't all that many people attached to 6 the Internet yet and if every member of the public were 7 attached, it probably wouldn't work very well.
8 So the Commission urges us to remember that 9 there are still many people that depend on paper and even 10 for those of us who use the Net, paper is often very 11 useful to us. So the Commission urges close attention to 12 the appropriateness of technology.
13 The Commission also wants a more coordinated 14 effort at public communication, but wants the 15 implementation of our communication program to remain the 16 responsibility of program offices. I may be reading 17 between the lines here, because the Commission, in issuing 18 some 16 sets of preliminary views on these issues, didn't 19 have time to go into lengthy explanations, but I think 20 what the Commissioners are aiming at here probably is to 21 make sure that no one in the NRC thinks that public 22 communication is someone else's business or is the 23 exclusive business of the Office of Public Affairs or the I
l 24 office of the General Counsel. It should be fully 25 integrated into our activities, even though it has a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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44 1 central focus.
2 The last item in the Commission's preliminary 3 views is what I alerted you to earlier. It's a variation 4 on the option to maximize or to focus on maximizing the 4
5 effectiveness and economy. As I said before, that could 6- be an expensive proposition if you were to draw up a plan 7 of assessment and go about assessing each one of these 8
l things. So the Commission has taken a more cost effective 9 approach here, one could argue, and it has essentially two l
j 10 parts. That is, if this becomes the final view of the 11 Commission, the staff should focus on the highest cost 12 activities and see if we're really getting what we want 13 for our money and, moreover, each time some change is j 14 proposed, to look carefully at the costs and the benefits 15 of that change.
I 16 That's a quick view of an extremely important
- 17 subject. One could argue that it's somehow not right to 18 be setting this off as a direction setting issue. That 19 it's an issue which is always there. Failure in public 20 communications is a very costly thing.
21 on the other hand, we just issued two policy 22 statements and a report on public responsiveness last year 23 and so one could wonder why this issue is suddenly coming i
24 up in this context. But, as I said, it's an extremely i 25 important one. You'll find this morning that it affects a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 great many other direction setting issues and the time 2 seems to be right to look at this closely.
3 So I'm through and I'll turn it over to Chip.
4 MR. CAMERON: Okay, thanks a lot, Steve.
5 As Steve noted, the Commission's preliminary 6 view focused on early identification of issues and this 7 preliminary view, as well as the entire paper, was based 8 on an analysis of what's worked for us, what's not worked 9 for us in the past and I would like to hear some comment 10 on this issue. Not only on the Commission's preliminary 11 views, but suggestions for how preliminary views could be 12 implemented in terms of early identification of the 13 issues.
14 Steve talked a lot about costs and benefits of 15 various communications initiatives. Are there any 16 suggestions about how the Commission might go about 17 analyzing what it should do in this area and how do you 18 evaluate costs and benefits in a public communications 19 area? How do you define success in this particular area? l 20 I'll go out to you. Do we have a lead off 21 comment?
22 Yes?
23 MS. ERICKSON: Hello, my name is Kristin 1
24 Erickson. I'm the Radiation Safety Officer at Michigan 1 25 State University where we run a big broad licensed program NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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46 l 1 and of course have low radioactive waves, along with other i 2 issues to which the public has been sensitized.
3 In recent years, we also had a large incident 4 involving off site release, which could have initiated a i 5 tremendous public outcry.
6 I believe that the NRC needs to not only take 7 their preliminary identification of early issues, but in 8 fact put option three and expand in large part what l
9 they're doing. I believe that the NRC needs to take the i
10 role of the tutorial with the public because I think we're i 11 all aware the public ignorance precipitates tremendous i
12 problems when we try to deal with an incident or even deal l i
13 with some daily operations in our sites. )
14 And if the NRC were to do this, it would be 15 better even than our own licensees because the NRC is the !
16 watch dog, per se, in the eyes of the public. Their
)
17 credibility is not that of fox looking after the chickens.
18 Now, to analyze the problem, I think that what 19 the NRC could do and licensees, I'm sure, would cooperate, 20 we would, would be to look-at prior problem, prior 21 incidents, cases where the public problems were high and 22 then see what went wrong. How fast was this told to the j 23 public? How was it told to the public, if at all? And' 24 analyze those problems and then also look at places where 25 they have similar incidents or difficulties and don't have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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- 47 1 a public outcry and why did it work? That would be a good 2 start.
3 I think the idea of the Web being increased, a
4 films, publications, little booklets could be a really 5 good way to educate the public and then on top of that, 6 reaching into the schools, the high schools, the grade i 7 schools would be a really fine option, too.
, 8 MR. CAMERON: Great, very thoughtful comment,
, 1 9 Kristin. One of your comments, about looking at l
10 particular incidents and what worked and what didn't in !
4 l 11 terms of public reaction reminds me of some of the same !
12 problems that face a particular industry that runs into a l 1 !
13 problem. <
14 For example, if you all remember the Tylenol l 15 scare back a few years ago, which I guess centered in -
i 16 Illinois or when AT&T lost its long distance line, how to
- 17 react to that. What's the best way to react to those i
18 incidents? Do you just sort of go inside your shell and
) 19 hide or do you become more proactive? I I i
[ 20 How about comments on Kristin's suggestions? l l
~
21 Do we have any on that?.
22 Yes?
23 MR. MERCURIO: I'm Derrick Mercurio with 24 Southern California Edison.
2 25 I very much agree with Kristin's position. .I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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48 1 think that there's a general lack of any. concerted or 2 effective effort on educating the public. We've been 3 ignoring that, especially like Kristin said, in our 4 schools, starting with elementary through secondary and
- 5 high school, colleges-also.
6 If the NRC doesn't want to take this role 7 because they feel that it's not in their regulatory 8 interest, we need to work with the NRC and find a way to 9 get this accomplished. Maybe the DOE is'the right place 10 to take the lead in this effort and like Kristin'said, the 11 industry would be seen as too self serving, if we're the 12 only ones to do this. We need to do more within the 13 industry, but it also needs to be a governmental program i
14 so we don't appear to be on our own band wagon. -
15 If we don't do this, there won't be a nuclear 16 industry, there won't be an NRC, either, if we don't start 17 now. We may be too late now. We're a dying industry. -
18 We've got a lot of plants shutting down. No one is buying 19 any new plants. We're not licensing any more. What we ,
20 have, we're trying to hang on and we're not doing very 21 well because what's going on in the whole industry and the 22 economy.
23 In California we're already going into 24 competition and will we survive? We don't know. We're 25 doing everything we can, but we don't know where we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 going to be in three, five, seven years.
2 There's also something that doesn't make sense i
i 3 to me in this country, just a general perception, my own 4 personal view is we have to be at least ten times safer 5 than other countries in how we handle our nuclear power i 6 program. There's also the perception we're a hundred, my 7 perception is we're a hundred times more dead as an 8 industry as the rest of the world.
9 That doesn't make sense to me. Why are we 10 there? We haven't been educating the public and not our 11 legislatures, Congress, state legislators. We haven't 12 been doing that education. We need to do that. We must 13 combat the negative publicity that the press uses, the
- 14 media and also the existing mind sets. Our children see 15 things like Bart Simpson making a fool out of himself. We
, 16 have to get back and educate people starting at that
! 17 level. Otherwise we're not going to be here. It's takes 4
18 a lot of education, effective education, not just 4
[ 19 technical, engineering types of education, to get through 20 to the public.
21 We have to have this education or the judges 22 and juries aren't going to understand what is the process 23 of what's going on and they'll be coming out with-24 judgements against the nuclear industry. We can't take 25 very much of that. We're not going to survive if that's NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. l (202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 l
50 1 what happens, if there's negative reaction to our i
2 technical approach to our industry.
3 Engineers are notorious for not understanding 4 the big picture issues. We lose sight of the big pictures 5 by getting lost in the details. Talking just to 6 ourselves, not reaching out to the. rest of the public.
7 They're the people, they're the ones who are going to
- 8 decide whether we exist or not.
9 The opening comment you had, the path we're on 10 will lead either to despair or distinction. Unless we do i
11 something, and start now, we may be too late not, but 1
-12 surely if we don't start to do a lot more now, then those !
l 13 are the two paths we're on.
14 The NRC must look at their responsibility and 15 contribution to the demise of the industry. We must both q 16 examine our roles and become part of the solution to 17 creating a healthy nuclear industry in this country. The l 18 ship is sinking and good people are leaving it in droves L
19 now to go somewhere else so they'll have a career for the 20- next 20 years instead of thinking they're not going to 21 have a job in three to five or seven years being in this l 22 industry. I 23 And if our hearts aren't in the right place, 24 the message we put out to the country isn't going to work, 25 if we just come from a pure technical viewpoint. If we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l_
1 51 l 1 think that this is too big a task, if it's too much work l
2 to go out and do all this, then we've made our decision to l
)
3 whether we think nuclear power is safe, is worthwhile, it i
j 4 contributes to the health of this country or provides 5 alternate energy supplies as a strategic balance against j 6 other energy supplies and the control other countries have 7 over our energy supplies when we buy oil and all the other l 1
8 energy supplies.
9 MR. C.',MERON: Thank you very much, Derek.
l 10 What we've just heard, I'd like to continue j I
11 this thread. We've just heard a couple of suggestions 12 along the educational front. One looking at particular i 13 incidents that might happen, the second looking at a more 14 broader, generic public education approach to the use of l 15 nuclear materials.
16 Do we have some more comments on this public 17 education aspect, the fear of crossing the line to being 18 promotional that Steve brought up?
19 Steve, did you have anything to say?
20 MR. CROCKETT: Just one matter of fact and 21 then perhaps a question.
22 The matter of fact is there are many people on 23 the staff who year in and year out do communicate to the 24 public about technical issues. They go into the schools 25 under a voluntary program. As far as I know, a lot of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 that has been pretty successful. So it's not that we 2 haven't done some of this work. The question is whether 3 we do it; more systematically, whether we try to train 4 ourselves to do it, whether we devote more resources to 5 it. This is not a categorical question. It's a question l
)
6 of degree.
7 I say that as a matter of fact and I think 8 some of'the NRC staff people in the room here today have l
)
9 engaged in some of that, or at least they have been in l
10 many public meetings. That's a large part of their work ,
l
} 11 and I admire them for it. All I've had to do is go into :
j 12 court, which is easy by comparison.
13 The question I have is how does one avoid i s
14 crossing the promotional line? It would be a lot easier, 15 for instance, if the Department of Energy were to take 16 over some program, although it might be discounted as too 4
[' 17 promotional. Is there such a thing as a neutral 18 presentation of the technical issues in an area like 19 nuclear power and could, the minute the NRC stated a fact 1
1 20 that seemed to lead toward the industry, would we be 21 viewed as promotional or the minute we stated what we 22 viewed as a technical fact that seemed to lead toward a 23 public interest group's position on the matter, would we
- 24 be seen as being in bed with the other side?
25 In many of these discussions, although the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 technical presenter may start out in an uncommitted, 2 unprejudicial way, the stakes are so high often,.that it's 3 almost impossible for the parties engaged in the subject 4 to hear it as something other than an attempt to side with 5 one party or another, 6 Now I suppose there's no perfect solution to 7 that and we shouldn't pretend that we could avoid that, 8 but maybe just consistency and dependable presentation of 9 facts would eventually make a lot of people trust-us. I 10 don't know, but I'd like suggestions for that kind of 11 thing.
12 MR. CAMERON: I think we have a comment here, 13 Roger?
14 MR. HUSTON: Roger Huston from NEI.
15 I think that one word that you used there, 16 Chip, is important, and that's facts. There is a concern, 17 there always has been a concern about saying anything 18 positive, crossing that line of being promotional. I 19 think that concern is overblown within the staff, to the 20 point where the staff tends to shy back from saying 21- anything that is positive because it might be construed as 22 promotional.
23 The public outreach aspects of the NRC don't 24 shy back from saying things that are negative and so it 25 becomes counter promotional. One objective way of looking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 at that, it's been a few years since I did the analysis, 2 but I went and looked at one year's worth of press 3 releases from the headquarters Office of Public Affairs 4 and when you weed out the administrative releases that 5 talk about meeting announcements and what not, a very 6 large portion of the substantive press releases reported 7 the imposition of large civil penalties for the industry 8 having done things wrong.
9 That's not balanced with a message of the
. 10 raaults of research programs, for example, which tend to 11 show that problems like direct containment heating aren't
^
12 as important as we thought they were a few years ago when 13 they were very publicly visible.
14 The think that needs to be kept in mind is 15 that the NRC is viewed as the objective party in this.
16 The industry needs to do more in terms of public relations 17 and its own education function. It would be nice if DOE 18 could do more of that, but we are viewed, not
, 19 inappropriately, as having a bias in this and the NRC has 20 been very effective in creating, in leaving itself visible
! 21 as the unbiased observer.
22 But when the editors of papers in the
, 23 neighborhood of nuclear power plants get press releases i
- 24 and those press releases continually paint the negative j 25 message from the unbiased observer, it can help tilt the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 l l
1 scales in a way that's not promotional, but also not 2 completely accurate.
3 MR. CROCKETT: Noted.
4 MR. CAMERON: Thank you very much, Roger. I 4
' i 5 think Roger has just made a suggestion about how the NRC l 1
.6 could avoid being regarded as promotional by keeping 2 7 everything very fact oriented and.I think that Derek would 8 also probably support that type of idea.
4 9 What about the idea that Roger has about the 10 press releases, the information coming out of the agency 11 being negative? I think we can all understand why that 12 might be so, but Roger, are you suggesting that perhaps 1
13 the Commission could spend more time, in other words, l
-l 14 talking about the positives about a plant like this plant U 15 was a particular good performer for a number of years, or
. 16 things like that. Is that the type of thing you're 17 suggesting? And I guess I would ask the rest of you 18 whether there are some more comments along these lines.
4
- 19 MR. HUSTON
- Well, I am suggesting there be 20 some more attempt made to try to identify what the !
21 positive messages are and I think keeping them to facts,
- 22 the results of programs, the conclusions that have been j 23 reached which are otherwise documented, but just not well 24 available, is a way to avoid looking promotional.
25 The situation with the civil penalties is NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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I 56 1 probably something, it's not intentional, it's just easy.
2 It's a crisp action and it's a crisp action of the agency 3 which there's a good process to reach out and capture and 4 say this is something that's important, this is something ]
i 5 that we have to make publicly visible and so it happens.
)
6 There's not such a program to capture some of the other l 7 aspects that might put forth a more positive message.
G MR. CAMERON: Okay, thank you. We're going to 9 go back to Kristin. Yeah, why don't you use that mike, i- )
10 that would be great.
I 11 MS. ERICKSON: I'd like to make one more 12 comment and actually get to what I think is the nub of 13 this. problem and that is we don't have public trust, but-14 how can we have public trust when we're continually ,
15 talking with a forked tongue both at my level with my 16 users, at the University level right on up to the federal l 17 URC level. We give a mixed message.
18 We tell people, and it's our belief and our 19 knowledge that numbers of doses such as ten -- or five --
20 occupation or tiny doses have little, if any, deleterious 21 health effect and we know that this is true. There are 22 lots of facts which could be shared with the public to 23 prove this and convince them and I've done this, in fact, 24 not only with users on the public, and also I've done this 25 with media. It is possible, but the problem is we also go l l
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57 l 1 and tell them well, this incident or this problem is no 2 risk to public health and safety but yet the licensee is j 3 penalized or we tell our users well, don't worry, this is l
l 4 safe on our campus. We have numbers to show you haven't 5 got any dose, but you've got 100 DPM contamination. You l t 6 have to clean it up right now. .
i l 7 I mean, it goes right down to the tiny level
- 8 and the public knows this, We tell the public the same i
. 9 kind of thing. We tell them there isn't a problem with 1
5 10 radiation, that we're doing it perfectly safely. And, in i 1
( 11 fact, we're doing it so safely in this country that, as 12 Derek said, we're just about doing ourselves out of the 13 business.
I
- 14 One of our new draft guidances says that we -
j 15 must meet seven DPM in ash for monitoring of ash after a
f- 16 incineration for Carbon 14. That's not possible. I've 17 gotten lab 128 hours0.00148 days <br />0.0356 hours <br />2.116402e-4 weeks <br />4.8704e-5 months <br /> accounting time to even see it. Now, 18 what's the point of this? Where are we going with these 19 regulations, with these efforts? l 20 The tremendous costs that the whole society 21 pays for a program that goes beyond and beneath any known ,
22 risk. In fact, bene'ath the levels of the airs, the 23 variabilities of our genetic predisposition are the other 24 factors we have to look at. I get these questions and I 25 can't answer them.
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__ l
58 1 So I believe that until the NRC establishes 2 some kind of a threshold beneath which there are believed, l
3 to the best of our efforts, that there is no health- )
1 4- effect. _Until they establish, for example in security, I l
5 that beneath a certain few minuter of time'and a certain ;
~l 6 level of radiation, we don't have a problem, we will non i 7 be successful with the public because as long as we keep i
8 telling them two different things in the same message, 9 they're not going to believe us and the trust is not 10 there.
11 MR. CAMERON: Okay, thank you, Kristin.
i 12 Kristin is going to what she believes is a fundamental 13 root behind public trust, public credibility problem and 14 it could cut a number of ways and I think that some of 15 your comments are going to be addressed not only again, 16 this issue is going to come up not only in the risk 17 informed performance based paper, but it also will'be in I 18 the materials paper for sure.
19 Do we have any follow up on Kristin's remarks 20 on the, on what she termed the mixed message that we might 21 be sending? While there's little risk here, but then why 22 are our regulations so strict? You would say too 23 stringent, I guess. Do we have some comment on that 24 aspect of this?
25 Okay, how about the early identification of 1 I
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i 59 j
\
1 issues? I would take it that there are probably, is there j l \
2 anyone out here who disagrees with the fact that that i
3 would be a good idea for the Commission to pursue? I l 4 mean, it's probably the better uay to put it is that .
l l 5 again, this is this prioritization business of where you 6 spend your money to have the most effectiveness.
l 7 Any comment on this early identification of ,
l 8 issues? Are there ways that we have suggested doing this 9 that you think don't work? Are there other ways that we 10 can do early identification of issues? ,
11 This is to give all of you, to give you the i 12 opportunity to tell the Commission this is a concern, this 13 is an issue before the Commission sits down and makes a ,
I I 14 decision on a particular issue.
l 15 Any comments on that concept?
l 16 Okay, Mark?
17 MR. DORUFF: My name is Mark Doruff. I'm 18 Director of Environment and Safety Regulatory Affairs with' !
19 Amersham Corporation in Arlington Heights, Illinois.
f 20 Amersham is a major manufacturer and j 21 distributor of -- pharmaceuticals like science research-l 22 radio chemicals and sealed sources for use in medicine and .
4 l 23 quality and safety assurance.
24 And I have a comment related to how NRC, once i 25 having identified an issue and an issue worthy of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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60 1 communication to the regulated community or to the public, l
2 I would like to make one comment about the way that I
i 3 they're currently taking action on some of these issues.
l l
i l
4 And this-is regarding incidents that occur or issues that l
l 5 arise and subsequent information notices that are 6 released.
7 I would like to recommend that NRC take a more !
8 active role with the particular companies or' industries 1
9 that are affected by the information notices. Allow them
! l 10 the opportunity to if not become, if not involved in the I 11 development of the notice, but at least be provided with l 12 the opportunity to review the information that is provided l
13 to ensure that, number one, the issues are correctly ;
14 identified and number two, that the industry can be 15 available to add any clarification and also to make sure ;
16 that they are informed of the notice prior to the notice 17 being released for review by the regulated community and 18 by members of the public, including customers of some of 19 the companies affected by the information notices.
20 Recently, a notice went out concerning the
- 21. potential problems associated with heat sensitization of 22 sealed sources. This notice went out without the 23 knowledge of the manufacturers, such as Amersham, and the l
t 24 notice went. We received several calls from our customers l
l 25 questioning us about some of the information in the i
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61 1 information notice and we were not even aware that the 2 notice had been released. So we were caught a bit by l '3 surprise and it was an awkward situation for us to deal 4 with. l l
5 So we would like to recommend that in the ;
6 development and subsequent promulgation of information l
7 notices, that the affected companies or licensees be 8 involved in the process prior to release to avoid such 1 9 problems in the future. Thank you. ,
10 MR. CAMERON: Okay, thanks, Mark. I think 11 that's a suggestion that we haven't heard before in our 12 travels. Thank you for that. i 13 Other comments?
l 14 MR. BROOKMAN: Chip, this is Doug Brookman.
15 I'm wondering if the question shouldn't be slightly 16 recast. I'm wondering if the early identification methods i
17 could be improved; if there are other ways that the i i
18 Commission should consider identifying those issues and if 19 this group would like to comment on that.
20 MR. CAMERON: Okay, good.
21 Steve mentioned a couple of things that we're 22 doing already. Anybody have any additional suggestions on l
23 what we could do?
24 I think Mark suggested a variation on that, at
\
25 least involving the industry that may be affected by a ,
1 1
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62 1- particular information notice.
2 Is there any more general, any ideas of a more 3 general nature?
f 4 Okay, anybody have any other -- Stu, did you 5 want to say something? Go ahead.
6 MR. RUBIN: Yeah, with regard to the lessons 7 and the follow up from incident investigations and what we 8 call augmented inspection teams, typically there are 9 actions or action plans that are developed and those are
. 10 issued by headquarters, Executive Director for Operations l
11 for IITs and by the Regional Administrator for AITs and i
i 12 quite often those action plans do allude to requesting the i
13 staff to look at the need for follow up feedback 14 communications such as information notices and the like.
l -15 I do believe that at the present time, that 16 kind of information is not necessarily placed in the l-17 public domain right away. It is eventually put into l
18' feedback documents such as the AEOD annual report, which 19 does compile the lessons learned from the various incident 20 investigation teams as well as citing the staff actions.
l 21 One of the things that AEOD is doing right 22 now, as many of the offices are doing, is putting much of 23 their documentation on to the Internet and we will be i
24 putting our AEOD annual report on to the Internet and so, 25 for example, you will be able to see what are the staff l
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l 63 l 1 actions that have been assigned as a result of recent IITs l i
2 for which the actions are yet to be resolved.
3 And so there may be an opportunity here to 4 move up in time, putting that kind of information on the l l 5 Internet. So public and the industry can see what our 4
6 thoughts are in terms of developing feedback communication )
l
- .7 such as the information notice and thereby have an 8 opportunity to make a call and get involved. !
i l 9 MR. CAMERON: Would that be helpful, Mark,
. 10 that type of procedure, in terms of your specific issue? )
11 MR. DORUFF: Yeah, I think any mechanism that 12 can be employed to involve us in the process prior to 13 publication.of the notice would be much appreciated.
14 MR. CROCKETT: Could I cast a gray cloud over 15 that? I mean this not by way of, I mean this not to ,
)
16 dismiss your suggestion, but to challenge you a bit so 17 that if you should, at some later point, reduce it to 18 writing or want'to further comment on it, you take this l 19 into account.
20 There have been incidents in the past when 21 there has been close involvement between NRC staff and the 22 licensee in the development of a rule or something of that 23 sort, and there have been occasions where NRC people have 24 been reassigned or even occasionally moved out of the 25 agency as a result of that.
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1 64 l 1 Things can become very unfriendly if the wrong 2 kind of involvement takes place. You know, and I don't 3 think you would disagree with me, that there needs, the 4 agency and the licensees need to operate with each other 5 at arm's length. The question, though, is what does that 6 mean? What does that entail? And it may well be that we 7 can do something of the sort you're talking about. I know 8 the Federal Aviation Administration works with members of 9 the industry in a way that the NRC never has. I know that 10 the Occupational Safety and Health Administration now has 11 a program which operates more or less in lieu of 12 enforcement, which they provide assistance to regulated 13 parties to help them be in compliance.
14 There are other things we could be doing, but 15 when you propose things like this, and I welcome the 16 proposal and I've made notes on it and I want to think l
17 about it more, please don't forget that I don't think 1
18 anyone disagrees with the general abstract principle that I we should remain at arm's length and an NRC staff member 1
19 1 20 also somehow has to avoid conflict of interest.
21 MR. CAMERON: Okay, Tom, do you have a 22 response?
23 MR. TIPTON: Tom Tipton, NEI.
24 The downside risk of not involving those l 25 affected by the action that you're going to take is one, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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65 1
1 you're not going to get to the heart of the problem and, 2 two, you're going to further confuse the public. There
] .
3 are many ways that you can make this accessible to those l l
4 being affected by your information notice, bulletin, et j 5 cetera. You can put it in the PDR, notify the people it's 6 going to be there for 30 days and then take action.
7 What we see is if you send something out final 8 and it's wrong, that is totally confusing to the public 9 and it affects the industry in terms of we're having to I 10 back pedal and trying to figure out what to do.
I l
11 So there have to be ways where you can ,
12 continue with this arm's length attitude, but you can l 13 involve it in a public form, and we have a policy at 14 Nuclear Energy Institute. We do not receive any document .
l J
15 unless it's in the PDR. i 16 We have an obligation to the public to make 17 sure what you're asking us to do is, one, accurate and la two, doable, and three, needed for the heslth and safety 19 of the public.
20 MR. CROCKETT: Well, now that's exactly the 21 kind of argument I'm looking for. Two aspects of what you 22 said that are the kind of thing I'm trying to challenge 23 you to come up with. Number one, you're saying the whole 24 process of involvement should be public, or at least i 25 that's what I understood you to say. That is it's in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1 PDR for a while, giving you an opportunity to make some 2 comments before it goes final and second, if we don't do 3 this, we may end up provoking precisely the kind of 4 reaction that we wanted to avoid.
5 MR. TIPTON: In my many years in Washington, I 6 think the industry has always strongly supported a public 7 type forum to get --
8 MR. CROCKETT: I'm not saying you haven't.
9 MR. TIPTON: But the problem I have is that if 10 you go back and just look at most recent activity such as 11 your bulletin that came out on heavy loads, there was a 12 lot of confusion there and if it had come out for 30 days 13 of public comment before we had to respond to that, it 14 would have saved you a lot of headache in trying to figure 15 out what we've responded to and it would have saved our 16 industry a lot of headache in terms of spending money 17 maybe unnecessarily, which is really public money.
18 MR. CAMERON: Okay, thanks, Tom. Stu, did you 19 still want to comment before we go back to Frank Miraglia?
20 MR. RUBIN: Just one point, that there might 21 be a difference here in quality of the interface between 22 the commercial power reactor industry interfaced with NRC 23 and the materials area. In the power reactor side, info.
24 has been interfaced with the agency in terms of sharing 25 operational data and feedback communications and we do, in NEAL R GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1
1 fact,-have a memorandum of agreement with these two 2 nuclear power operations to coordinate and ensure that l l
3 there are not inconsistencies and conflicts in.our various 1
4 feedback documents.
5 I'm not sure that on the materials side.we 6 have a group that might be an industry wide organization 7 that could serve in that same role. I understand for 8 reasons of competition, there's not been a great impetus 9 for that, but at least on the reactor side we have 10 recognized and there have been lessons from the past that ;
l 11 there can be inconsistencies put out there and that can
.1 12 compound safety issues as opposed to resolving them.
13 To the point about additional time to review 14 bulletins, in terms of the issuance of some bulletins, 15 some are viewed as of an urgent nature which would no 16 allow or provide for the time that you would desire and 17 that',s a decision that's made internally. Whether or not 18 the safety significance and importance of the particular 19 action would entail not having enough time to get the j l
20 industry's comments on it. j 21 MR. CAMERON: Okay, I think we're going to l l
22 have to wrap up here' shortly. l 23 'Let's go to Frank Miraglia. l 24 MR. MIRAGLIA: I'll just build off what Stu 25 said. I was going to make the observation that in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.
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.1 reactor area, we do publish a list. It's in the PDR L 2- provided to - , I believe also to NEI th'at talks.about the
'f l 3 generic issues that we have under consideration for the i .. 4 issuance and - , generic-letters, bul'letins of a less 5 urgent nature and certainly - . So I'm-confirming what 3
6- Stu has already-told.you.
7 In addition, I think we've used a number of
{ 8 words.in discussing this issue in this arena that I think i
j 9- are very-important that perhaps have passed for 10 resolution. Arm's length, the industry has a role and we l 11 have a role and I think we have to walk a fine line to
- j. 12 make sure that that role is' clearly understood by.the 13 public. If you do these things wrong, the public trust 14 and.the public confidence'will be undermined and I think 15 Kristin made that kind of reference.
b 16 So facts are important and the clear-17 recognition of what each other's roles are so that the 18 public confidence'can be built and not eroded or seemed to 19 be eroded as a cooperative kind of nature. It's a tough 20 line, it's a tough issue. We've been trying to walk this 21 line for a long time and any thoughts and ideas anyone has 22 on how to do that better I think would certainly be 23 appreciated.
24 MR. CAMERON: Good, thank you very much.
'25 Okay, let's have one final comment from --
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l 69 !
1 MR. STRUSMA: I'm Jan Strusma, I'm the Region 2 Three Public Affairs Officer and I want to go all the way
)
3 back to Kristin's original comment where she mentioned 'n a l 4 incident they had with some off site contamination at the !
5 University of Michigan and it_could have been a very l
6 serious problem from a public point of view, but the J
7 reason it wasn't was the way the licensee handled it. You l
8 put out press released promptly. They talked to the j 9 staff. They told everybody what was going on and, as a ,
l 10 result, it wasn't a big deal. So I think you can't just 11 look to the NRC to solve your problems with dealing with 12 the public.
13 MR. CAMERON: Very nice wrap up, Jan, and I j l
14 think that this.is an interesting discussion because we l l
l 15 focused, I think, mainly on the public educational aspect 16 of the problem, both from a global, a macro point of view 17 and a perhaps a micro point of view and we appreciate the !
l 18 discussion on that issue and I think we'll go to Stu Rubin 19 now for the next paper, which is Role of Industry. !
20 MR. RUBIN: Good morning, again, I'm Stu 21 Rubin. I'm with the Office for Analysis and Evaluation of 22 Operational Data. Edward Jordan, the Office Director, was 23 not able to be here today. He was the sponsor of the 24 issue. I worked very closely with Ed and I'll be 25 presenting the DSI today.
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70 f
1 The first DSI I'd like to talk about is'DSI
^
2 13, which is the Role of Industry. Can I have the first 3 slide, please?
i 4 As shown on the first slide, as simply stated, 5 the issue asked the question in performing its regulatory I responsibilities, what consideration should the NRC give 6
7 to industry activities and so that really asks in what 8 area and in what ways, if any, should the NRC pursue 9 interaction with industry to increase the industry's
- 10 participation and support for NRC's public health and 11 safety mission.
12 It should be obvious that when we refer to the 13 term industry, it really broadly cuts across all of the j
14 regulatory arenas, non-power reactors, materials, as well 15 as the power reactors, of course.
16 And so if there is to be an effort that would 17 increase the industry's participation and if we were to 18 pursue a shift in the relative responsibilities between 19 the NRC and the industry, then it's clear that the 20 stakeholders, and especially the public, needs to be 21 involved in looking closely at this and they need to know 22 what will be the chdeks that the agency will have in place 23 to assure that these new balances are working and we do 24 need to hear from you today on this.
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1 pointed out that this is not a particularly new issue that 2 is being introduced for the first time. In fact, if you 3 look back over the last ten years, you would see that 4 there has, in fact, been a gradual shift toward increased 5 participation for some time now, and it has evolved and 6 has resulted in a gradual increase:in NRC's reliance on 7 the industry for self oversight activities with an ;
8 attendant decrease in the NRC's oversight activities.
9 But this gradual increase, again as I 10 indicated, has been evolutionary and it has, in fact, !
11 occurred in the absence of any specific NRC Commission 12 policy or any strategic plan. Instead, it's really been 13 driven by one of opportunity-where the industry will make 14 a specific proposal and the NRC would then look at that 15 within its statutory limits and if the staff's-review were 16 positive on the proposal and based on good trial 17 experience and with the appropriate level of continuing la ' oversight and audit involved, then the agency has approved 19 a number of these proposals over the years.
20 And this interaction with industry has 21 involved a number of initiatives. They span many of our 22 regulatory. areas, including inspections, performance 23 assessments and license examinations. And so the balance 24 today between NRC oversight activities and the self 25 regulation, you might say, efforts of industry has varied, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 l
'l depending on the program area you're looking at and it has 2~ shifted in the past, as I had said, it will likely 3 continue to evolve in the future.
4 So the opportunity and really the question l l
5 we're asking today is should the NRC be more proactive and i 6 more structured and organized in actually seeking to i 7 expand industry's role or.make their role better defined 8 or should the agency keep the-status quo that it has in 9 place now, with the more passive and case by case posture 10 in matters on increasing the industry's role and 11 participation.
12 Next slide, please.
13 These next two slides provide several of the 14 key factors, considerations that bear on these questions.
15 First of all, as a general matter and from'a legislative ')
i 16 standpoint, the NRC is obligated to, not to fail to !
i 17 perform or for that matter to delegate to a private party ;
18 any responsibility that the Congress has specifically 19 mandated in the legislation and in the laws.
20 And so, for example, in the Atomic Energy Act, 21 the Commission is not permitted to allow others to 22 determine whether the Commission should grant a license.
23 That is the Commission's responsibility in the 24 legislation. Neither may the NRC entirely rely on 25 industry standards. The legislation says that the agency
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73 1 must' establish its own regulatory standards, but it may 2 choose to adopt standards that are developed _by industry.
3 So there are restrictions that do apply based 4 on the legislation and if we wanted to go outside that 5 box, as we talked about, that we would require additional 6 legislation to make that happen.
7 Another factor that comes to play here, 8 obviously, is the conflict of interest or the potential 9 for conflict of interest. Any time you have a situation
'10 where say a licensee or industry organization is placed in 11 the position to check the adequacy of its own activities, 12 then you create at least a perception that there's less 13 objectivity, loss of impartiality in that oversight 14 activity. And so we obviously need to be conscious of 15 that. It really goes to the heart of the issue of public 16 confidence and trust. i 1
17 The public will also need to maintain its 18 access to safety information in order to keep its 19 confidence and trust in what we're doing. And so if 20 there's going to be an increase in the industry's self I
21 oversight, really by our legal obligations and what will 22 be necessary to keep that public trust, we will need to i
23 have agreements with the industry to ensure that there is 24 sufficient safety information that is made available as a 25 result of the activities that come out of the self NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 l' oversight area.
2 -And the public will need this information in 3 order to have confidence, first of all, that the self f 1 4 checking and self oversight process is working, but also 5 to have confidence that safety is being maintained at an 6 adequate level.
7 A fourth. factor or question that we have for 8 this issue is really address the commercial power reactor ;
9 industry and that really is that there has, in fact, been 10 a substantial overall improvement in performance within P
11 the industry for power reactors and, for example, the 12- overall frequency of transients, safety system actuations 13 and the extent of personnel over exposures has declined 14 significantly over the years and those have been clear and -
l
^
15 measurable in the agency's own performance indicators.as 16 well:as the industry's performance indicators and this is 17 translated into a measurable or calculable decline in the 18 overall plant risk.
t 19 So this performance improvement would suggest l 20 that there is a basis for expanding the industry's role l 21 and allowing for greater participation in the process.
22 However, for the materials and non-power reactors area, we 23 have a much more difficult time in measure performance and i
- 24 the trends not really as clear that performance has i 25 improved. i
=
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75 1 Now, on the other hand, there is, in fact, the 2 issue that based on past performance, you need to consider 3 the current context, I should say, and that is an 4 increasingly competitive environment that most industries, 5 including the nuclear industry, is finding themselves in 6 today. For example, the economic deregulation that we all 7 know about has added pressure on reactor licensees to 8 reduce their costs, while increasing the availability of 9 the units to produce power.
10 And so this economic stress, if you will, has 11 created a period now of increased sensitivity on the part 12 of the Commission and it's heightened the NRC's attention 13 to the conservatism of the safety decisions that are being 14 made by licensees. And so the economic stress factor 15 really represents a caution flag for the agency today in 16 the transfer of any additional responsibilities over to 17 industry.
18 Next slide, please.
19 At the same time, the industry has continued 20 to be concerned over the impact of even the current level 21 of NRC oversight activities and has questioned the need 22 for the level of inspection activities, for example, in 23 light of the current high level or higher level of 24 performance that we see. And so the agency must 25 acknowledge that regulations and regulatory oversight
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l 76 1 activities'are an economic cost factor for licenseer.
2 Codes and standards development, this is an 3 area of particular interest and enthusiasm by the sponsor 4 of the paper, Ed Jordan. He's a very strong advocate of 5 this and he believes that it really should be strongly l 1
6 considered in the option on industry involvement and the j i
7 Commission, if you would read the preliminary views, !
j 8 agrees with that as well.
9 Codes and standards development is an l 10 investment that the industry and the NRC must make in l
11 order to ensure that there's long term consistency and 12 reliability in the NRC's safety framework and also to l 13 ensure that there'is a clear understanding on both the 14 side of the staff, as well as the industry, as to what is l
15 expected to meet an adequate level'of safety. And there 16 needs to be an increase in that investment, or certainly 17 to maintain that investment.
18 Because, for example, as we move from a 19 prescriptive regulatory framework more into one that's -
20 risk informed and performance based, it will be essential 21 that we have in place the necessary comprehensive 22 infrastructure of codes and standards and regulatory 23 guides to allow both the staff and industry to have an 24 efficiently viable basis to conduct safety review 25 activities'within this new framework.
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77 1 So codes and standards are really an essential 2 prerequisite for that successful transition.
3 And finally there's the fact.that-the 4 industry, and this has been mentioned at least several 5 times and will be over the next two days, is that we are 6 in a period, the agency is in a period of declining 7 7 resources. The NRC's budget is certainly getting tighter.
P 8 Congress and the OMB continue to reduce our budget and so.
9 the agency's resources are continuing to be more 10 constrained and the size of our workforce is going down 11 with each passing year. !
.12 And it must be acknowledged that the industry 13 is also tightening its belt, it's reducing its staff and 14 making its operations more efficient. And so the 15 declining resources clearly is a challenge for industry 16 and NRC to allow usito develop these new frameworks that 17 we will need as we move into this new environment.
18 But to reap the rewards in the later years, we 19 really need to make that investment now, both sides.
20 Next slide, please.
21 Now, there are five options that are proposed 22 in the issue paper, and they shouldn't be viewed as 23 mutually exclusive, except perhaps for the first two.
24 The first option would simply continue on with 25 the current program, which would be a deliberate and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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78 i
1 evolutionary case by case review of proposals as they come l 2 up by industry. And so as opportunities were to arise and 3 proposals are made to support NCR's responsibilities, they )
i 4 would be evaluated and negotiated with industry and the l 5 proper interface would be developed and the proper 6 oversight and audit methodology would be put in place by 7 the agency and approvals would come about.
1 I
8 The second option really is for the NRC to 9 Secome much more proactive and active in seeking out new 10 opportunities and initiatives for industry participation.
11 To allow for more aggressive expansion of industry's role.
12 The third option would be to increase the use 13 of accreditation and certification of licensee activities 14 by. qualified professional societies and industry groups 15 and technical associations. In this particular case, the 16 accreditation and certification criteria and standards 17 would be subject, as they always have been, to NRC's 18 review and acceptance and the accreditation process, once 19 implemented, would also be subject to an ongoing audit l 20 level review by the NRC staff to ensure that it's working 21 properly.
22 The fourth option would be to increase NRC's 23 interaction with industry and professional groups in order 24 to develop codes and standards and guidance documents, as l 25 I mentioned earlier.
1 i
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79 1 And the last option would be to utilize what 2 we call or is called a designated industry representative 3 as a means of supplementing NRC's on sight inspection 4 activities at selected facilities.
5 But.before we go to the next slide, I'd like 6 to talk a little more about each of those options so 7 there's a little more clarity in in what we're saying 8 here.
9 Again, as far as the first option, we continue 10 the current program and it would be accurate to say that 11 that current effort by both the NRC and the industry has 12 been considerable and is likely to remain so. In fact, 13 there are many ongoing reviews as we speak that would 14 increase industry's participation in the oversight area.
15 An example of this would be the reactor 16 operator license examination program. It's regulated by 17 the NRC and that has seen an increase in industry 18 participation and' responsibility. And, again, this has 19 allowed for a reduction of NRC's resource needs to ensure 20 that that kind of activity is being conducted adequately.
21 The tech. spec. improvement program is another 22 area for power reactors in which the agency and regulated 23 industry have interacted and it has resulted in much more 24 consistent and standardized tech. specs. The program has 25 reduced the sheer volume in the number of technical !
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80 1 specifications and has resulted in certain material being 2 placed in licensee control documents and where we are is 3 that the agency is not put in the position of having to 4 formally review many, many minor changes to the tech.
5 specs. and this has been viewed as a beneficial successful 6 effort on-both sides.
7 Also, the ability of licensees to make minor 8- changes to their QA plans and their emergency plans and 9 security plans without NRC review is also beneficial to 10 both sides.
11 There's also been good success recently in 12 allowing licensees to conduct their own success with 13 licensee qualifications to do that are clear and this has 14- allowed the NRC to do an audit level' review of the process 15 that they conducted, as well as the results, and has been i
16 a successful alternative to what you'might call the full '!
17 scope NRC review, which is very resource intensive. !
18 Now, as far as the implications of the current 19 program, we believe that this, if we would implement, it l 20 would result in a slow decline in NRC's resource 21 requirements while the industry's workload to carry out 22 these additional sel'f oversight activities would gradually 23 increase, as would the NRC's reliance on industry.
24 We also think based on the experience and the 25 evidence to date that implementing such or continuing such NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 a program, we wouldn't expect to see a significant decline 2 or change in the NRC's credibility with the public and we 3 also think that the current program could be pursued 4 within the current legislative framework, but we do not 5 expect the industry's safety performance, per se, to be 6 affected either way by implementing the current program.
7 Now, with the second option, the agency again 8 would be very proactive and aggressively seek out a broad 9 expanded role of industry in the regulatory areas such as l 10 inspections and performance monitoring. But, again, in 11 any event it would still be subject and any approvals i
l 12 would still be subject to a continuing ongoing audit level i 13 review by the agency for such activities.
14 Now, with respect to option two, we would 15 expect that there would be a higher initial investment 16 cost to the agency, as well as the industry, but we also 17 would expect that there might, in fact, be a decline in 18 NRC's credibility as an effective regulator in the eyes of 19 the public if we were to implement this option.
20 There also could be areas that might involve 21 requirements for further legislation to allow us to 22 implement an expansion of industry's role.
23 The third option again would be to increase 24 the accreditation and certification of licensee activities 25 and this would involve NRC interacting with qualified NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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82 1 industry groups and professional societies who could 2 develop and implement a qualified accreditation program.
3 For option three, the considerations with respect to the 4 initial costs and the public credibility and reliance on 5 industry are about the same as I discussed in the second 6 option.
7 Moving to the fourth option, the fourth option 8 would be to increase the interaction with industry groups 9 to increase our participation in developing national 10 consensus codes and standards and various guides, which 11 could be endorsed by NRC. This we believe is important.
12 It would provide additional rigor and specificity to the 13 regulatory framework and prove both the efficiency and the 14 effectiveness of the conduct of safety activities.
15 Here again, there would be an increase in 16 initial up front costs for both the NRC and the industry, 17 but in the long haul, we do anticipate that this would 18 lead to a decline in the overall resource requirements 19 again due to the greater efficiency and effectiveness with 20 which activities would be conducted on both sides. We 21 wouldn't see a need for any legislation here for this 22 option, but one of the important advantages we think is 23 that we would see an improvement in licensee performance l 24 as a result of implementing this option, which we think is 25 a real attractive feature of this particular option.
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l 83 i
1 The last option, option five, the designated i 2 industry representative and the idea here would be to have 3 an expert licensee employee or industry representative who 4 would be designated or selected by the NRC and who would 5 be authorized by the NRC to perform certain inspection and 6 regulatory review activities at a specific site and the 7 thought would be that this designated industry expert 8 would supplement the current level of NRC's inspection 9 activities and not be a replacement or a substitute for 10 that current level of regulatory oversight.
11 And we think that this could have some, we I
12 believe this has some application where the particular i
13 activities that will be looked at are particularly complex '
14 and very specialized where the agency does not have the 15 resources to maintain its own expertise within the 16 Commission.
17 Again, as far as the considerations and 18 implications, we do believe that there would be additional 19 up front costs for both the NRC and industry in setting up 20 the program. It would also involve a long term cost to 21 the industry to provide people who would support the 22 agency's mission. We also do believe that there could be 23 a negative impact on the credibility of the agency if that 24 individual was perceived as replacing NRC inspection 25 activity as opposed to suppJementing the NRC's inspection NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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84 1 activity.
i 2 But if, in fact, that was what we wanted as an l l 3 alternate to NRC inspection activity, there certainly 4 would be a legislative requirement to make that happen.
5 Next slide, please. !
1 J
'6 As far as the Commission's preliminary views 7 are concerned, the Commission's preliminary views are that 8 the staff should expeditiously pursue option one, which is 9 really a vigorous implementation of the current program 10 and to do that within our current budget considerations 11 and the Commission has also indicated that we are to 12 pursue option four, which is to increase our interaction l
l.
13 on industry on standards and code development.
14 As far as option one is concerned, the 15 Commission has indicated that staff should continue to 16 evaluate industry initiatives on a case by case basis and 17 they have further indicated that the staff should develop 18 guidance and criteria for the use in guiding and l 19 evaluating industry proposals and to make the staff's 20 reviews more efficient and consistent and again to have a 21 consistent-basis for approval.
22 Next slide, please. ~i 23 As far as option four is concerned, the 24 Commission again has expressed a preliminary view that the 25 staff should increase its focus and emphasis on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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85 1 interacting with industry in order to develop new codes i
- ! 2 and standards and guidance documents and they have also
~
, 3 indicated that the initial development activities should i 4 be focused on PRA applications as well as the medical use 5 program area.
]
6 The Commission has also requested that the 7 staff identify and recommend areas where codes.and
- 8 standards and guides would be of special value. Areas for 1 '9 priority and emphasis and to feed back those suggestions 10 to the Commission.
11 The last slide, please.
1 2
12 As seen on the last slide, with regard to l 13 option five, the Commission's preliminary review of that, i
14 although it's not a preferred option, the designated 7 15 industry representative they believe might have potential ,
16 for application to what_I referred as large, broad scope i
} 17 material licensees, but if option five were ever 1 18 implemented, it should be utilized, as I indicated before,
- 19 to augment or supplement the current level of NRC s
20 inspection oversight and not as a substitute for NRC's '
i' 21 oversight activities.
22 So that's kind of basically an overview of the 23 paper and what I'd like to do now is just sit down and 24 open it up for questions. Thank you.
25 MR. CAMERON: Good, thank you very much, Stu.
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86 .
1 g
1 Just a couple of things before we go to you, 1
l ,
2 keep in mind for this paper and all the papers, the four
- - 3 questions that the Commission flagged for particular i
, 4 attention at the beginning of the Strategic Assessment 3
! 5 materials. One, are there any issues that we missed in l 6 considering the strategic areas. Two are the assumptions !
e i- 7 or the key factors that we have identified, are they i '
8 correct. Third, specific comment on'the Commission's
, 9 preliminary views and the fourth question applies only to l 10 some papers, which I think we'll get into more this 11 afternoon and tomorrow. There's some specific questions
. 12 that the Commission had on some of the papers.
i ,
13 And just to sort of segway from our public
(
1 14 communications paper, you can see that Stu has raised, '
\ l j 15 does the reliance on industry raise any questions in terms !
16 of public trust, public credibility. Are there some l
l 17 cautionary things there that we should keep in mind? And 18 too if we do go to more reliance on the industry, what's 1:
19 the role of the public? What's the access to information 1
20 that ti.e public gets if we move more to reliance on the Y
21 industry?
22 And with that, I'll open it up for comment.
i- 23 Roger?
I i 24 MR. HUSTON: Roger Huston, NEI, and I
? l j 25 apologize for going outside the bounds of those four i !
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87 1 questions right after you've just so carefully laid them 2 out, Chip, but I'm in a position where I've got to make a 3 clarifying comment almost. We've been at the previous two 4 meetings here and I've gotten some questions off to the 5- side about how could we be opposed to option two, 6 expanding the role of the industry and that's somewhat a l 7 function of the label, the title that's been applied to ,
l 8 the individual options. l 9 As Stu explained, but I'll got a little bit 10 further, option two as described in the paper, would 11 involve a significantly expanded role for the industry.
12 As described, it would involve turning, shifting some NRC 13 functions in a fairly large manner over to licensees or to 14 l some technically qualified group established by licensees 15 to be done consistent with the current NRC process.
16 As an example, inspection has been talked 17 about elsewhere here, but um cher example that's talked 18 about in this option is a qualified industry group might 19 conduct pre-evaluations or preassessments of licensing 20 actions that the NRC could then come in and audit and they 21 ultimately would take the licensing action, but the 22 technical work might be done in the industry.
23 We do think that that kind of a shift is 24 inappropriate and that it would indeed lead to the kinds 25 of credibility problems that you just talked about, Chip.
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88
?
- 1 We do believe that an expanded role for che industry is 2
appropriate, but we prefer to reach that kind of 3 additional role through option one, through continuation 4 of the current program, much as the Commission has 5 indicated in their previous views and the example of 1
6 operator licensing and the increased. involvement of the 7 industry in the operator licensing program is significant.
8 We can emulate that example, we can evaluate things on a
- , 9 case by case basis.
10 We can consider each of them in their l
11 individual context, both in terms of safety significance,
, 12 the appropriateness of individual roles and the
[ 13 involvement of the public, the availability of information 14 for the public.
15 So just as a matter of clarification, we're 16 not opposed to expanding the role of industry, but we're 17 not in favor of option two as described in the paper.
18 MR. CAMERON: Okay, thank you very much, 19 Roger. That's a useful reminder for us, I think, and I 20 don't mean to constrain anybody to be only within the 21 bounds of the four questions. Those questions are more as 22- a guide for all of us to think about the directed 23 strategic issues, but that was a good clarification 24 reminder on that.
25 How about other people out here on role of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS {
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89
-1 industry?
2 Mark?
3' MR. DORUFF: Again, my name is Mark Doruff, 4 I'm'with Amersham. I'm also here representing an industry 5 group known as the Council on Radio -- and Radio i
6 Pharmaceuticals also known as CORAR. CORAR is an industry 7 group that is an association of companies with common 8 interests in radio - , specifically the manufacture and 9 distribution of radio pharmaceuticals, sealed sources'and 10 radio chemicals for life science reseur h.
11 I would like to make some comments on DSI 13 12 and I'll start out by saying that CORAR supports some 13 elements of two, three and four and I would like to sort 14 of piggy back on~what Roger said about the fact that while 15 we do support an expanded role of industry, we support 16 option number two. We don't necessarily agree with all of 17 the elements presented in that option and I think we're 18 more supportive of some of the other elements of two, 19 three and four and I'll expand on those briefly.
20 One comment on the assumption that's made on l
21 page six on the DSI and guess somewhat in disagreement !
22 that Stu made earlier this morning on DSI 14 that 1
23 materials licensees are often seen as competitors that j 24 tend to compete with each other and do not really reach a 25 consensus on technical issues. I think CORAR is a good NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N,W.
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90 1 example. Our industry has worked together and we have not 2 only reached consensus in a number of technical areas, but 3 we've been proactive in the rule making processes that 4 have been made available to us and we appreciate the fact 5 that NRC has been open to our participation-and we would 6 like to see that not only continue, but we'd also like to 7 see that role expanded.
i 8 We support the concept of accreditation by 9 industry groups and certification of industrial 10 representatives included in option number three. We also 11 support the concept in option two of 4acreasing industry's 12 role by allowing more self assessment in the regulatory l 13 process. i 1
14 NRC points out that they are experiencing a 15 decline in agency resources and we believe that increasing 16 the role of self assessment in industry could provide an 17 opportunity to lift the burden that is currently on NRC in 18 this issue of lack of resources. One example where 19 application of increasing the role of self assessment 20 could help in this area would be the allowance of 21 manufacturers of approved containers and registered sealed 22 sources and devices to be able to evaluate design and 23 manufacturing changes with regard to their QA programs.
24 We don't believe that enough credit is given in the area l
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91 1 regulated licensees to make assessments with regard to 4
2 their plans that certain minor changes are, these changes 3 can be made without a formal review by the regulated, by )
4 the agencies regulating these containers and these j 5 devices.
6 We also support the use of industry groups for 1
7 the development and endorsement of codes, standards and 8 guidelines as included in option number four and we 9 support the recognition ofk he Commission's preliminary 10 view.
11 MR. CAMERON: Okay, thank you, Mark.
12 Mal Knapp?
13 MR. KNAPP: I'd like to respond briefly to the 14 comment about the strength of industry groups and 15 materials.
16 Your point is very well taken. In the 17 original write up, one of the things we noted was that the 18 materials licensees for the NRC cover a very broad range j 19 of licensees from large fuel cycle facilities through
'20 pharmaceutical manufacturers, hospitals down to individual 21' radiographers and gauge users and in some cases you were 22 quite correct, there.are some strong groups.
23 In some aspects of the materials program, we 24 don't find as many strong ones. I appreciate your 25 correction.
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92 1 MR. CAMERON: Okay, thanks, Mal.
> l 2 Mark has, Bob, could we see the first i
. 3 preliminary view slide? Thanks, Bob.
4 I think the key word up here is initiatives.
5 In other words, this case by case proposals for further 6 reliance on the industry and I think Mark just gave us a 7 good example of one of those initiatives that could be 8 under taken.
9 Doesanydhdyelse_haveanyothersuggestions 10 that might not have surfaced in the paper for specific 11 initiatives where that the NRC might pursue along these i 12 lines in terms of increasing industry activities as an 13 alternative for NRC regulation?
14 MR. FARRON: Yeah, Paul Farron from Wisconsin 15 Electric.
16 Just as an example, I think that OSHA is 17 probably in the same position that NRC is right now or NRC l 18 is going to be as far as manpower constraints and while I 19 haven't looked at the paper in its entirety, I know that 20 OSHA has used some mechanisms where for good performers, 21 proven performers, they have reduced the level of on site,. l 22 continuous on site review and come in on set frequencies 23 to audit or look at the company's programs and I think 24 that might be an area to look at.
l r
25 Also, I don't know if the NRC has considered NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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93 1 it, but the insurance carriers, too, for the industry do r
~
2 look at a lot of the same things that the NRC looks at too
]
3 for public health and safety. I know that NRC has 4 informally asked various parts of the insurance groups for 5 information about their inspection activities. Now, I 6 don't know if there may be some problems with conflict of 7 interest with this, but it may'be an area to look at as 8 well.
- 9 MR. CAMERON: Thank you very much, Paul.
10 Those are useful suggestions.
11 Anybody else have anything along those lines?
l 12 Kristin?
13 MS. ERICKSON: It would help me if we could
- 14 put the other slide up with the options as I make a couple l 15 of comments on these.
16 It appears to me that with the current rules 17 and programs as they exist for a broad scope licensee, 18 such as Michigan State, that many of these are already i
. 19 incorporated. For example, the bottom one, designated 20 industry representative, well that's myself, it's a 1
21 Radiation Safety Officer. I view myself as a miniature 22 NRC and even in teaching and training explain that yes, I 23 do work for the University, but I truly report to the NRC 24 and I truly work for them to implement these rules and 25 keep things safe. So it seems that's already in existence NEAL R. GROSS
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94 1 for any place that has an RSO.
2 The second option, expanding the role of 3 industry, I think that's happening. At least in our L 4 institution and in the State of Michigan on somewhat of a 5 performence basis, we are trying out with the NRC some new 6 things, looking at our laboratories and our institution in 7 a performance way. It's working very, very well and I l
8 think that this second option, in a more vigorous way, as 9 is kind of stated in the NRC's preliminary view, is what l
10 needs to be done.
I 11 This is the perfect timing to have more l
12 cooperation, more dancing, if you would put it at arm's 13 length, yes, not the up close dancing with the licensee, i 14 but to have it happen where there is some coordination and j 15 we don't have so much of this ready, fire, aim approach
]
l 16 that then causes problems for everyone.
l l 17 The business of the accreditation and 4 l
18 certification, I think that's already in existence again, 19 in the broad scope manner. We do a tremendously intensive 20 audit of our own program, myself and my staff spend two or 21 three months and then ongoing throughout the year looking l
22 at ourselves just ruthlessly and then we write a 23 tremendously big report with details and charts and 24 graphs, present it to the Radiation Safety Committee and,
[ 25 in fact now, we've been doing it for several years, that's l
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95 1 the first thing that I hand to the team inspectors and it 2 helps them to focus because we self identify in complete 3 honesty and talk about corrective action. l
, Or if the i 1
1 1 4 corrective actions can't happen, we tell why can't they be 1
5 that, that it's not reasonable or that it will never -
6 happen in any institution like ours.
7 The increased interaction with the industry 8 and the professional groups, again I'see that as already 9 beginning. I don't know if it's going on throughout the 10 country and from talking to other licensees, I think not, 11 but at least in our region, I can comment that in Region 12 Three between our university and the Region Three people, 13 we have a tremendously fine cooperation that is not 14 compromised by collusion of any sort, but I'm completely 15 free to call them and discuss issues or, even as I said, ,
16 dig into the lab to come up with some numbers when they ;
1 17 don't have the time or perhaps the expertise on some l
18 issues. We have a fine cooperation but that is not 19 destructive to credibility on the part of either 20 institution.
21 And, in fact, what it does in the eyes of the l
22 public is it's incre'ased our credibility with the public I 23 because the NRC does understand what we do and we do work 24 together with them a lot and the public knows this, 25 whether it be small numbers on campus or again in the NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 !
l 1 public outreach. l l
2 So I'm in favor of the expansion and I think I 3 it's happening, at least on a trial basis, and I would l
4 like to see it continue. I 1
1 5 MR. CAMERON: Thank you very much, Kristin.
4 6 I want to follow up on a couple of your J
7 points. First, I'll go to George Pangburn.
8 MR. PANGBURN: George Pangburn from NRC. ,
9 You were talking about licensee performance j l
10' and decreased inspection frequency and on time. At least j 4
11 with respect to materials licensees, we put into place l
12 about 15 months ago a program that would take into account 13 inspection findings of materials licensees and the regions- ;
14 have flexibility now to decrease the frequency or increase I 15 the frequency, based on performance. That's one area 16 where we have taken that particular factor into account.
17 MR. CAMERON: So I guess there may be more 18 along those lines that we could at least consider or 19 examples from other agencies, I guess is something I don't 20 know if we've explored comprehensively.
21 Kristin brought up a couple of interesting i
22 ideas. I thought one is'this, goes to this designated J 23 industry representative option and her view that the 1 24 Radiation Safety Office already is functioning like that
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97 1 clarification from NRC, about potential distinctions 2 between the designated rep. concept presented here and the 3 Radiation Safety Officer. Is it a matter of degree or a 4 difference in kind?
5 And also, is there any gold to be mined in 6 this headquarters / regional dichotomy perhaps. Kristin was 7 talking about the good relationship they have in Region 8 Three. Is there anything more that can.be done in regard 9 to this paper in terms of increased regional interaction?
10 I would just open that up. Anybody have any 11 comments on the designated rep. issue?
12' Mal?
13 MR. KNAPP: Malcom Knapp, NRC.
14 I think Kristin is correct in saying that the 15 relationship which she has with the NRC is very similar to 16 a designated industry representative. I would say the.
17 difference, in my mind, is that the designated 18 representative might be more like the relationship that I 19 believe the FAA has with certain of its, I believe they're 20 called designated industry representatives in aircraft 21 manufacturers and it's very similar in a number of ways to 22 an RSO except that it's more formal. I believe the FAA 23 uses a more formal approach in deciding what the 24 qualifications of the representatives are and I believe 25 there is a, perhaps even a sworn oath statement to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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98 1 FAA. I'm.not real clear on the process, but you're ,
2 correct that they're similar. I think it would simply be 3 to take.where you are right now and go a bit further.
4 MR. CAMERON: So that's a good comment then 5 because it may not be such a stretch in this particular 6 case.
7 Anything else on designated representative?
8 Any comments from some of our state government 9 representatives on how they view the relationship with the 10 industry as they go about their regulatory activities as 11 it relates to any of these options or this issues paper?
12 okay, any final comments on this?
13 Kathy?
14 MS. ALLEN: Kathy Allen from the Illinois l 1
15 Department of Nuclear Safety. )
l 16 I just wanted to raise a couple of points on 17 option three, for increased accreditation and 18 certification. The industrial radiographer certification 19 program supported by the -- has been successfully 20 implemented and that was also supported by the industry 21 and I think you need to look at some of those other types 22 of accreditation programs. Not necessarily as a direct 23 cost savings measure, but as a way to improve safety and 24 put the requirements for safety and training back on the 25 licensees and let them have control of their programs.
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99 1 Rn example would be accreditation requirements 2 for nuclear medicine technologist. Illinois, as well as 3 many other agreement stat 3s, have programs for 4 accreditation. We believe that it enhances radiation 5 safety by requiring the actual users, people handing the 6 radioactive material, to be trained and maintain 7 certification.
8 Contrary to the statements made on page 16 of 9 this DSI, certification of personnel does not 10 automatically reduce inspection frequencies or the level 11 of oversight provided by the department. However, what we 12 find is that accreditation requirements allows the i
13 licensee to demonstrate diligence in complying with the 14 other department regulations and they may actually end up j l
15 with reduced numbers of' violations. They have better 16 control of their programs. !
17 So.what you see is just a very good program.
18 We don't automatically say well, since we have an 19 accreditation program, we're never inspecting again. I 20 just think you should look at other alternatives like 21 that.
22 MR. CAMERON: Okay, thanks a lot, Kathy.
23 I know that we have one more paper to go here, 24 but perhaps this would be a good idea to at least give you 25 a short break to get some coffee and we are going to start NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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I- 100 )
[i 1 on.the dot at 25 after and see if we can get done'with
- 2 this final paper by noon break for lunch. '
3 (Whereupon, a short break was taken.) ,
i 4 MR. CAMERON: Okay, if everyone can take their 2
5 seats. We're going to do the final paper for this morning
- 6 and as you'll notice, this paper is on Regulatory i
7 Excellence and Stu Rubin is going to do this presentation
! 8 for us and he's going to explain what this concept of 1
9 Regulatory Excellence is all about. !
j -10 Stu?
11 MR. . RUBIN: Thank you, Chip.
' i 12 Okay, the second DSI I'd like to talk about is
! 13 DSI 23. As Chip indicated, the title is Enhancing j i
e-14 Regulatory Excellence. l .
)
- 15 The concept of DSI 23 is perhaps somewhat i -;
i ;
i- 16 unique among the set of DSI's because it is very much l l
17 internally focused on the agency's processes and its i'
1 18 people rather than externally directed, as most of the i
j 19 others are, toward the regulated community.
20' But even so, I think that it is-important that 21 we-do obtain comments from external stakeholders. I'm !
22 sure there's a lot of good ideas and there's opportunities i
- 23 for participation by external stakeholders on how NRC does 24 its internal oversight activities.
25 Can I have the first slide, please?
f
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101 1- I showed on this' slide the strategic issue 2 that asks the question: How can the NRC enhance j 3 regulatory excellence through the maintenance of 4 regulatory standards, rules, and requirements. But the 5 issue.I stated in this particular slide is perhaps
'6 somewhat too restricted. It really represents how the 7 Steering Committee actually proposed it in the initial
, 8 going, but the Commission and the Committee now would seek l 9 to apply this concept of regulatory excellence and its i j 10 goal much more broadly than originally considered.
1 11 The Steering Committee, in conducting its 12 reviews and trying to extract the strategic issues that we 13 see here today, initially assumed that the staff's 14 performance, as far as the staff's performance was J
15 concerned, it was kind of implicit and it was expected 16 that excellence would be part of the staff's follow 17 through on implementation of the selected options or there
'f 18 was a thought.that the notion of the options themselves 19 and the selection by the Commission had in it inherently 4
c 20 the thought of excellence and how we were going to operate 21 as we move into the future.
22 And so it seemed, at least in the beginning,
- 23 that it was self evident that excellence was implicit in 24 everything we were doing and in terms of the staff 25 carrying out its regulatory activities. Well, despite NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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i 102 j 1 that view and that presumption, when you read the words in 2 the DSI's and you take a look at other activities that are l 3 ongoing, some of the external factors and some of the l
4 internal factors that you'll see in these papers, you do i 5 come away with a very definite sense that an emphasis is 6 on greater efficiency and economies in terms of how NRC is 7 going to conduct its business to reduce its costs. These 8 show up also as a byproduct of risk informed performance 9 based approaches which still reduce burden on licensees, 10 but they do have the potential for reducing costs.
11 And then there's also, as indicated in the 12 previous issue paper, the thought that the agency would be 13 looking at reducing its own regulatory oversight and 14 putting in place greater industry roles in self oversight.
15 And when you looked at the words in the issue 16 papers, there's really very little that you would see in 17 the way of the notion of excellence, on how we might 18 improve what we are doing currently and as we move forward 19 into the new environment that we're finding ourselves.
20 So taken all together, there was a concern 21 that when you read this body of work, that we might be 22 putting out the wrong message to the staff. There might 1
23 be a mistaken impression on the part of the staff that the 1
24 priority for the agency had become one of regulatory !
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I 103 1 in some way the pursuit of regulatory excellence in 2 carrying out our work in the most exemplary way possible.
3 So based on this further review, we thought l
l 4 that it would be important to have a specific DSI that was 5 focused in on our own internal processes, with a goal of 6 enhancing regulatory excellence or achieving regulatory 7 excellence as an explicit goal.
i 8 What I'd like to do is mention briefly what we .
9 do mean by the term regulatory excellence and what we 10 don't mean.by the term regulatory excellence. For 11 purposes of this discussion, regulatory excellence is 12 defined as a dedication to safety, a commitment to the >
13 principles of good regulation and the pursuit of superior ,
14 staff performance.
15 And I would add that regulatory excellence, ,
16 since it is internally focused, it is. aimed at the NRC 17 staff, its performance and its own processes, should be 18 differentiated from what the industry, the nuclear power ,
J 19 industry specifically would perceive that the NRC seeks to 20 apply an ever higher level.of excellence that's aimed at 21 the performance of licensed facilities.
22 There is clearly a difference there. What 23 we're' talking about here is the internal excellence of the 24 staff and the thought is that we would try to achieve, 25 what we are seeking here is for the staff to do its job, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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104 1 its own job in an exemplary way and it should not be 2 construed as a quest for excellence for licensed 3 facilities operation.
4 Next slide, please.
5 These next two slides identify the key factors 6 that we see in pursuing or enhancing excellence in the 7 staff's internal programs and internal performance.
8 First of all, I'd like to say that NRC views 9 itself as what's called a learning organization and 10 therefore rooted in our own organizational values is a 11 culture which historically has sought to improve its own 12 effectiveness in the way it conducts its own work and all 13 of its regulatory activities, direct and indirect, on 14 regulatory oversight.
15 And so the agency has and it does have in-16 place a number of mechanisms that routinely assess its own 17 internal performance. For example, there are many what we 18 would call lessons learned reviews, self assessments and 19 audits of our own regulatory oversight processes and cur 20 procedures. We look at the adequacy of the qualification 21' and training of our staff and its ability to effectively 22 carry out their responsibilities.
23 I would also add the agency has been 24 responsive to external stimuli and lessons. We do take 25 advantage of the -- excuse me, let me back up a minute.
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105 1 Going back to internal reviews, we also i 2 respond to things such as NRC Inspector General audits, as 3
3 well as staff differing professional views on matters. We i 4 also would be responsive to any lessons on our processes 5 that come about as a result of research findings. So we 6 would seek to develop improvements from these other kinds-n 7 of internal activities.
, 8 And so there are an extensive number of 9 ongoing activities within the agency that have occurred j ,
- l'0 and will continue to occur to improve our effectiveness 11 regardless of DSI 13 and its options -- excuse me, 23 and 12 its options.
13 Again, as I was to say, the agency is also
)
[ 14 responsive to lessons learned from external events and
]
] 15 experiences, including those involving congressional as i
16 well as judicial and executive branch initiatives that 17 have been directed over the years at improving NRC's i-18 regulatory framework.
19 But I would add that the processes that we
! 20 have in place today do not have as a specific goal one of i 21 regulatory excellence nor would one be able to say that i 22 the improvement initiatives and activities, when taken 23 together, that we are currently have in place would 24 necessarily be sufficient to achieve the goals of 25 excellence.
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106 4 1 Another important consideration that I would 2 mention or I mentioned earlier, was the apparent concern l 3 or the belief that the cost reduction tone of the DSI's i
4 and other recent initiatives might, when taken together, 5 leave the staff with the mistaken impression that somehow 6 we were backing away from the agency's top priority and 7 commitment to a vigorous approach to safety, oversight and 8 safety review and regulatory effectiveness and carrying 9 our public health and safety mission.
10 And this consideration is a very important 11 one. It cannot be over-emphasized and was perhaps the 12 main stimuli in a way for. initiating this particular DSI 13 review.
14 Next slide, please.
15 Certainly the idea that changes that improve 16 the efficiency of regulation for the~NRC and the 17 efficiency of compliance for licensees have been and will 18 continue to be of interest to licensees and the industries 19 that the NRC regulates, but at the same time, we don't l 20 think that industry has put any particular' emphasis on 21 changes that are specifically focused on enhancing NRC's 22 regulatory program effectiveness.
23 And the last point, again, is in the declining 24 NRC budget environment, it will become more and more 25 difficult for the agency to make those added investments NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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107 1 necessary to achieve those improvements in our processes 2 and our programs and our people that are needed to achieve 3 a goal of regulatory excellence.
4 Next slide, please.
5 And again, as I mentioned earlier, the NRC's '
6 credibility as an effective regulator has declined as'a 7 result'of lapses which have occurred in the staff's '
8 oversight processes and so this issue paper really 9 provides certain options to address those regulatory 10 process issues and the performance of the agency people 11 and by doing so would help to restore the credibility that 12 may have been lost with the public and with the regulated 13 industry and with ourselves.
14 Next slide, please.
15 As far as the options are concerned, there 16 really are only two that have been identified. In most of 17 the other issue papers, there are a number of options that 18 are identified, some that would do less than we're 19 currently doing, some that would do the same and some that 20- would do more than we're currently doing.
21' DSI 23 does not provide an option to do less 22 than we're currently doing to improve the way we do 23 business.
24 The first option we have sets as a minimum 25 continue what we're currently doing to improve our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1 regulatory performance internally and, again,=it would be 2 fair to say that that activity level has been rather 3 significant. It's been one of considerable dimension and l 4 involves a significant number of staff resources as we go ,
5 on. ,
6 Again, the agency feels it is a learning ,
7 organization and it does apply an extensive number of 8 continuous. improvement initiatives that do span virtually
')
9 every activity area within the agency, every program and 10 process within the agency. I 11 With regard to that first option, continue the 12 current approach, the NRC there would simply continue to i
13 conduct the periodic program self assessments from both 14 reactors and materials and non-power reactors arenas and 15 we would continue to see improvements as a result of those 16 activities as we went along. These activities, these I
17 evaluations would be conducted by the responsible program 18 office or staff office and it would be expected from this 19 process that we would identify specific weaknesses in 20 these programs and these activities. l 21 And so it would be expected that specific 22 improvements would be made as we move along into this 23 changing environment that we now see ourselves in.
24 Also for option one, the staff would continue 25 to respond to weaknesses that were identified by external NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l 109 j 1 sources such as industry, allegars, the Congress and the 1
2 like, and as well as from regulatory lessons identified 3 from licensee, or excuse me, NRC incident investigations 1
4 of operational events. '
5 For this option, we believe that the agency's 6 resource expenditures to identify problems and to respond l
7 to internal and external lessons would be expected to 8 continue at about the same' current level we are at now, 9 but we don't believe that the current program would offer i
10 us any significant new opportunities for increasing the 11 agency's pace with which it provides for proactive 12 improvement versus being in a mode where the agency finds 13 itself reacting to lessons that are identified.
14 Also, as I mentioned before, by simply 15 continuing the current approach to improvement, there is l
16 the concern that the staff's efforts to improve the 17 efficiency of our regulatory framework could lead to a 18 staff misperception that we are somehow softening our 19 safety vigilance and so I think that one of the principle 20 reasons that the Committee felt that there needed to be a ]
l 21 regulatory effectiveness issue, that this was an i i
22 appropriate issue that needed to be considered very l
23 strongly and of course by continuing the current approach 1 l
24 the rate of improvement in the public perception of NRC as 25 an effective regulator, that pace of improvement would 1
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110 i 1 really not change over what we're seeing today.
l l 2 But there is a question of whether that would 3 really be enough or whether we need to have a more overt 4 and direct and accelerated effort at improvement and so a 5 second option has becn developed which would initiate what 6 we would call a more proactive approach to improvement. I 7 think it's fair to say that Ed Jordan, the spensor of this 8 DSI, that's where he comes out and if you read the 9 Commission preliminary views, that's where they come out, 10 as well.
11 And that would be to pursue the more proactive 12 improvement approach. And so with option two, the NRC i 13 would have other additional measures built on top of the 14 current level of or supplementing the existing base of 15 improvement initiatives associated with option one. For 16 this option, the paper proposes to add a senior management 17 review group to periodically review the agency's internal 18 processes and to identify regulatory program areas and 1
19 staff performance issues for priority attention and i
20 improvement.
21 The key issues for the more proactive 22 improvement approach would involve a substantial 23 additional up front investment of agency resources and -
24 additional management attention to achieve these I
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111 ,
I 1 have an important beneficial side effect, as I indicated, 2 in assuring that the staff's regulatory effectiveness 3 culture does not begin to erode.
4 And we also believe that with option two' the 5 agency would more rapidly regain its credibility with the 6 public as an effective regulator as improvements were made 7 at a more rapid pace.
8 Next slide, please.
9 As far as the Commission's preliminary views j 1
10 are concerned, their views were basically that the staff l 11 should go ahead and develop and implement strategies that 12 would improve NRC's internal performance and, in fact, l l
13 they did opt for eption two which is to take the more l
14 proactive approach to improvement.
15 But as I mentioned, they.did request that, or 16 haven't yet mentioned, I should mention that they 17 requested that the staff expand the scope that was 18 originally proposed in the paper and the concept of 19 regulatory excellence should be applied to all agency 20 programs, not just to the regulatory framework, the 21 dealing with codes and standards and guidance documents.
22 They felt that whether activities were directly or 23 indirectly involved with regulatory oversight, all should 24 be included in a regulatory excellence initiative.
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112 1 and finance and information management which would also be 2 included in the regulatory excellence initiative.
3 And the Commission also had the preliminary 4 view that the staff nhould identify goals and mile stones 5 and provide a means to fully engage the workforce, the 6 staff at the grass roots level so as to better identify 7 and achieve the improvements that would be needed to 8 achieve excellence.
9 And so although for option two, the paper 10 proposes to begin the more proactive approach for just the >
11 regulatory programs and expand it later based on success l l
12 and suitable time in that arena, the Commission felt that !
l 13 the staff should start right off with the broadest l
14 possible proactive improvement campaign within the agency 15 applied to all the agency's programs and activities.
16 The Commission also urged the staff to assign 17 the necessary resources that would be needed to allow for 18 the greatest possible benefits to be achieved at the 19 earliest possible time.
20 And basically that's a summary of DSI 23 and 21 I'd be willing to take any questions or comments on this 22 particular issue paper at this time.
23 MR. CAMERON: Thanks a lot, Stu. Before we 24 get into discussion on this issue, I have one important 25 announcement to make.
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l l
113 1 When you have this microphone, it's not just 2 like it's a - , I have the talking stick and this allows 3 me to talk. There's also another function, which is so l
l 4 that it goes into the microphone system and I got a short 5 course on this just a few minutes ago and this is wrong .
6 and also if you are talking this way, it goes over the 7 mike. So when you are talking into it, try to direct your 8 speech right into the microphone and I guess we'll go to ;
9 regulatory excellence and how does the NRC build this into 10 its operations and have we identified all the ways to 11 build it in?
12 David, do you want to talk now?
13 MR. SWANK: Dave Swank, Supply System.
14 I guess I have a question to start with. ;
15 Something I didn't see in this DSI or, in fact, in any of 16 the DSI's was a discussion of any baselining that the NRC 17 may have done against other federal agencies or, for that I i
18 matter, foreign agencies performing the same function as 19 the NRC. Was that part of the process and is it intended 20 to be part of the process?
21 MR. CAMERON: NRC, any answers to that, Stu or 22 anybody else here?
23 Jim Milhoan.
I
- 24 MR. MILHOAN
- Jim Milhoan, NRC.
I 25 As part of our assessment of the individual I l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l 114 l l 1 activity, one of the things that we did look at was the j i
2 internal and external factors to the extent that it was i 3 described and it was not described in any great detail. If 4 there was anything related to internal and external 5 factors from foreign activities, we tried to capture that i 6 in our assessment in the first phase, but I think more !
7- direct to your question is with respect to the baseline 8 against foreign practice, in the operating reactor paper, i 9 one of the preliminary views talks about us looking at 10 foreign practice whenever we're looking at the operating 11 reactor oversight issue.
12 And so to that extent, in the future when we l 13 do the implementation, it would certainly be looked at
]
1 14 with respect to the foreign experience and the experience j 15 of others related to that.
16 Mal, in the materials area, did you have a 17 anything in the materials area that would cover the 1
i 18 foreign experience?
19 MR. KNAPP: In materials, we really didn't do 20 it explicitly. Within some areas we look at these things, 21 waste management and other areas, but we did not cover 22 this as heavily as we might have. I think that's a good 23 comment.
24 MR. CAMERON: Okay, David, implied in your 25 question is something that I would like to hear from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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115 1 rest of the group about is that are there things that y
2 other agencies, other organizations are doing in regard to 3 regulatory excellence that the NRC might profitably 4 pursue.
5 Do you have anything to offer us along those 6 lines? Not right now, okay.
7 Steve?
8 MR. COLLINS: Steve Collins with the Illinois 9 Department of Nuclear Safety representing the organization 10 of Agreement States. There are 29 agreement states that 11 regulate more than two-thirds of the licensees in this 12 country,_other than the nuclear power reactors,.and we do 13 have seven officers elected each year through either them I
14 or their designees come and speak at public forums like ;
15 this to let you know what the majority of those states 16 feel.
17 With regard to the question that was posed, 18 basically we view that NRC in this Strategic Assessment 19 and Rebaselining Study has decided how it can do or try to 20 determine how it can do better what it's currently doing 21 and after this process is done, we have suggested already 22 that they need to go back and work with the agreement 23 states and industry and everybody else, their l 1
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116 l 1 and relook at the whole thing from the beginning again and 2 say what should we really be doing and that will come out 3 earlier -- do the high risk things and cut out some of the 4 low risk things.
5 The Organization of Agreement States viewed on 6 DSI 23 in-general is that we concur with the Commission's 7 initial views. The proactive approach to regulatory 8 framework is desirable and with their new view that it 9 should not be limited to just those initial items that 10 were mentioned on the first slide. That the continual 11 quality improvement in all areas and consultation with 12 stakeholders should be sought and particularly with 13 reviewing regulations, eliminating or changing those that 14 are too restrictive, exempting those sources that pose no l 15 significant risk to the general public and concentrating 16 efforts on radioactive material uses that have higher 17 risk.
18 MR. CAMERON: Okay, thank you, Steve, for 19 those Agreement State comments and one thing for people to 20 keep in mind for further discussion is something, I think, 21 was implied in what Steve said, that perhaps in addition 22 to the institutional mechanism that the Commission is 23 considering here, the senior management review team, but l
l 24 that there's also important sources of advice outside the i
25 Commission on this whole idea of regulatory excellence.
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117 1 Would you agree with that?
2' MR. COLLINS: Yes.
1 3 MR. CAMERON: Okay. Derek?
- 4 MR. MERCURIO: Derek Mercurio with Southern 5 California Edison. i j 6 We agree with the Commission's decision for 7 more proactive approach. The issue paper focuses on
- 8 regulatory effectiveness, which denotes a regulatory l
( 9 framework for ensuring public health and safety. That is l i
l i 10 l clear, coherent, logical, consistent, reliable and 11 technically sound.
12 It then provides a background in the appendix, 13 a description of improvements that have been made over the 14 years to that regulatory framework. However, when 15 examined together, all these improvements fall far short-16 of it being clear, coherent, logical, consistent, reliable !
17 und technically sound.
18 For the most part, we see the adoption of 19 specific prescriptive regulatory approached and 20 requirements, but no consistent or coherent level of 21 safety significance supporting what was just said. The 22 most notable exception is the performance based 23 maintenance rule. However, the effectiveness of even that 24 rule, the maintenance rule, will depend on how the NRC 25 inspects through this rule. Whether their enforcement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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118 1 practices will be they be based on performance instead of i
2 detailed compliance.
I 3 What isn't addressed in the issue paper is 4 that there has never been a consistent underlying basis 5 for the NRC's regulatory framework. It has been driven by 6 the event of the day. Even though you need to respond to j 7 the event of the day, it still needs to be responded to in 8 the context of an overall general, clear, consistent
, 9 policy.
i 10 We object to the statement on page eight, that 11 licensees have not emphasized changes specifically focused 12 on enhancing regulatory effectiveness. On the contrary, 13 in an attempt to provide a focused regulatory framework, 14 the industry proposed NEI 9604 enhancing nuclear plant l
15 safety.and reliability through risk based and performance l i
16 based regulation. The goal of this initiative is to focus l 17 the NRC and the industry on more risk significant issues.
18 We're concerned to find the NRC's 19 consideration of risk informed and performance based 20 regulation relegated to a background discussion of recent 21 initiatives as opposed to being the corner stone of a new 22 regulatory framework.
23 The key to enhancing regulatory ex:ellence is 24- to establish this consistent, coherent, logical regulatory 25 framework for all NRC actions, whether this be in rule NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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119 1
1 making, in review of a licensing action, performing .
2 inspections or in enforcement. Every action by a member j 3' of the NRC staff needs to be part of the overall 4 regulatory picture.
5 It is important that the NRC establish an 6 overall regulatory framework,-such as that addressed in l 7 NEI'9604. If the best way to make this happen is to set: i 8 up a proactive review group that's discussed in option 9- two, that's the option we endorse. However, if that is ,
l 10 not the intent of-option two, then it would be better to 11 go with option one.
l 12 MR. CAMERON: Okay, thank you, Derek. Let's 13 get a clarification on your last point right now.
14 Is the review group an inherent part of option 15 two, I guess is the question?.
l 16 .MR. RUBIN: Yes, it is. The process we have l 17 in place righ't now is very decentralized in a way. Each 18 office works its own program areas, regulatory program 19 areas and identifies activities for improvement would 20 include many of the things that you have just mentioned.
21 What we're talking about here is building on 22 that additional organization, if you will, that would 23 establish top agency priorities for high priority 24 initiatives that need to be undertaken by the agency to 25 improve its' framework and would set priorities and provide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l l
(. 120 ]
l-1 oversight for those special areas that the agency would I 1
2 pursue.
! 3 The fact that the Commission has said that !
4 this program needs to be broadly scoped to include all i j
5 functional areas does present a challenge to this :
6 particular group on which areas to go after first, but I 7 would venture to say that the areas of concern that you j i
8 have mentioned would, in my mind at least, be considered 9 among the top priorities to be addressed within the 10 agency.
11 MR. CAMERON: Thank you very much, Stu.
12 Do we have some other comments on the 13 regulatory excellence issue?
14 Yes?
15 MR. FRAASS: Ron Fraass with the Radiation 16 Control Program, State of Kansas.
17 I want to affirm Steve Collins' remarks on 18 behalf of the Organization of Agreement States. Kansas 19 was the ninth of the Agreement States. We are also trying 20 to seek regulatory excellence with our own material 21 licensees.
22 To that end, we view as our goal compliance.
l 23 That's shared by our parent agency, which is Kansas l
[ 24 Department of Health and Environment. We believe that a i
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121 1 regulate to lead them toward compliance. We seem to be 2 getting a real good response in that area. Folks are ,
3 coming to us saying, we have a problem. Can you lead us
! 4 to other folks'in similar industries that have.the problem i i l 5 and have already solved it? We try to do that. That's 6 one of the approaches we're taking towards regulatory 7 excellence in Kansas.
l '8 MR. CAMERON: Thank you very much. That's ;
9 something that we've heard before, I think, in other l 10 contexts, is the whole idea of compliance versus 11 enforcement. Thank you. '
l l 12 Tom?
13 MR. TIPTON: Tom Tipton, NEI.
l 14 I agree with the comment of looking at other l 15 federal agencies and the international community.
l 16 Have you also looked at some of your internal
! 17 reviews that have gone on and let me give an example.
l 18 The Office of Inspector General came out with 19 a special evaluation report in May of 1995 entitled quote ,
20 Now is the Opportune Time to Reexamine NRC's l 21 Organizational Structure, end of quote, and in there they i
! 22 discuss the fact that you need to focus on eliminating 23 duplication, reducing program inconsistencies, et cetera.
24 There are other documents out of the Inspector 25 General's office that focus on things like this. So have
[
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l 122 1 you gone through and looked at those activities that you 2 already have in hand?
3 MR. CAMERON: Good suggestion, Tom.
l
-4' Jim Milhoan?
5 MR. MILHOAN: Tom, thank you for the comment.
6 '
With respect to the specifics of the IG 7 reports, in fact we do look at each IG report and for 8 those and most of them request a response, we review those i
9 and we provide a response back to the IG.
10 With respect, though, of looking at the 11 activities that we have, I don't disagree with that and 12 that's a good comment, i
13 MR. TIPTON: Tom Tipton again. Thanks, Jim.
14 Stu, in your review of this, and this may be a i
15 little more detail that you went through, did you find any l 16 areas where the NRC feels that you no longer have to 17 provide oversight review?
18 MR. RUBIN: Well, the paper was really not j 19 focused on specific program areas. I think that you would 20 sooner see those in the specific DSI papers and evaluating 21 whether or not additional oversight is warranted and I 22 think it does come up as options in other papers.
l 23 That would be viewed perhaps more in terms of 24 best possible utilization of resources or efficiency and 25 that was not really the focus of the paper. It was really l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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1 2,23 l
~ l 1 one of_ consistency and rigor and reliability of how we do i l
2 our jobs. And so we would do it in the most exemplary I i
3 manner. )
4 So that was really not the focus and I would !
5 suggest that that might be found in other papers.
6 MR. CAMERON: Thank you, Frank.
7 MR. MIRAGLIA: Yeah, Frank Miraglia, NRC. l
(
8 I'd just like to add a little more context.to l 9 what Stu has already said.
10 In terms of each of the papers, if you look i
11 at, lots of things have been discussed here, risk informed I i
12 regulation. We do have a specific issue paper on how
.13 should we apply that across all of the regulatory .l 14 processes.
15 The point to this paper is that if you~look ;
16 across most of the issue: papers, we have one of regulating l
17 areas of low risk in terms of the material area. There's '
18 a question of that we need to get the regulatory base 19 clearly defined so we are concentrating on the important 20 things.
21 To build on the comment about compliance, to 1
22 get the regulatory b'ase and compliance as a circle of one I 23 and that we are paying attention to the right kinds of ;
24 things and if there are rules out there that are not l
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124 1 change the rules and that's an element that flows through l 1
2 all of the issue papers.
1 3 This here paper is saying, is an internal look 4 and saying that while we're talking about those kinds of 5 efficiencies, we need to do something internal to make 6 sure that the excellence of the staff's performance and 7 meeting the agency's goals and missions is heightened and S it's not that we're backing away from those safety goals 1
9 and those safety missions and that kind of thing and so l 10 this was more of an internal structure. Regulatory 1
11 excellence by the performance of the staff. Regulatory l 12 efficiency and effectiveness of each of the rules is built I 13 into all 16 papers and are ongoing activities. I 14 Maintenance rule has been mentioned as an area that we're 15 proceeding in and we're looking to apply that in other 16 areas, as well.
17 So I think Stu is right, is that some of those 18 elements that you're talking about are embodied within all 19 of the issue papers and the various options and many of 20 those is how much, how fast, how deep, how broad and that 21 goes back to the question that Chip raised in diminishing 22 resources, each of these issue papers has priorities 23 within the paper and then there's relationships between 24 the issue papers. More attention to materials, more 25 attention to high level - , more attention to reactors and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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125 l 1 how will those trade offs be made? That's the goal and 1
4 2 the objective that the Commission is trying to get a sense 1
3 from the stakeholders. If you have views on those kinds '
4 of things, that's what it would like to hear in response 1
5 to some of the comments on the issues you're hearing today 6 and the rest of the day and tomorrow.
7 MR. CAMERON: Okay, thank you very much, 8 Frank. ;
9 There was one suggestion in the paper, at l 10 least about an institutional mechanism for regulatory l
11 excellence, was with the senior management review team.
12 How about other types of strategies such as 13 training or something like that?
14 MR. KELLY: My name is Glen Kelly. I'm with l
I 15 the staff at NRC and I have a little bit different 16 perspective and I want to discuss, perhaps see what kind )
17 of comments people have about how the enhancing regulatory 18 excellence is going to have an impact on the staff, which 19 in turn is going to have an impact on the industry.
20 Many members of the staff are already 21 significantly burdened working on the things that they're 22 doing currently that management or they believe are the 23 very important things to be doing.
24 If you look at what's in the various options, 25 say for example option two here, the discussion might NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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126 l'
imply that there would be many additional things coming on j 2 the plates of people in the staff, such as doing more work-3 on 5059, more work on design basis, perhaps many more l
4 inspections ccming out of headquarters. All of this
, 1 5 additional work is going to take away from something and -
6 the question is where is that work, where is that coming 7- away from? How does that affect people? Does that mean 8 licensing actions are going to take a lot longer to 9 perform than they were in the past? What do we give up in
~ 10 order to gain this additional work?
11 And.I think that's probably one of the things 12 that will come out of this, but I know the staff members 13 are concerned about that because they want to make sure 14 that urgent things don't push aside the important things. i 15 So I'd be interested in hearing what industry has to say 16 about this.
17 MR. CAMERON: Okay, good point, Glen. I think 18- that's an important point, is the more burden there is on 19 the staff because of decreasing resources, the more 20 potential there is for regulatory excellence to sort of 21 decrease just because of that increased burden and that 22 perhaps some sort of prioritization of importance would 23 help maintain a level of regulatory excellence. That's a 24 good question for all of us to consider.
l l 25 Derrick?
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--.____-.;.__ . _ _ _ . _ . - . . _ - ___ -... ~ . ~ . _ . _.- - _ _ _ _ ._ _ .._ _ _
127 J 1 MR.-MERCURIO: Derrick Mercurio, Southern 4
2 California Edison.
3 One minor response to Frank Miraglia. We're :
4 i 4 looking for a consistency and understanding from the j
1 5 regulation, from all of the levels of the regulators, 4
6 right from the top management to the reviewers, programs 7 managers, inspectors. So it's more where we're talking !
8 about this in alignment consistency through all the NRC,
, 9 top down, side to side, that's what we're referencing. I i
't 10 think that's understood. 3 i 11 MR. CAMERON: Okay, thanks, Derrick, i.
12 Kristin?
13 MS. ERICKSON: Is this better? <
14 I hope you'll all bear with me, because I'll !
15 tell you I'm going to probably comment all day long 16 because I not only represent ourself, but something of an 17 informal consortium of large university broad licensees.
18 I think our issue here goes right back to the 19 other issues, and they're all intrinsicly entwined and I 20 have a saying on my office door that says, If you don't 21 like radioactivity, the earth is no place to live. And, 22 in fact, that's what we've been doing. I tell the 23 activists they need to find the universal radioactive 24 waste site and ship the whole earth and everybody on it if 25 they want to get rid of the danger of radiation.
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128 1 I will take slight disagreement with Derrick l 2 in that the NRC, I believe, does have a baseline policy 3 upon which everything goes back and that is, again, little '
4 or no threshold meaning that'any radiation is assumed to 5 have some danger and because of that, it goes back to what 6 I said on my office door, that any radiation, anything l
7 that comes up can be a problem and triggers tremendous '
8 amounts of work and I-know at the NRC level it's the same l 9 thing we do with our staff on campus.
10 And we have to spend horrendous amounts of 11 energies on things that are no risk because of that 12 policy. The NRC, likewise, has the same problem. The 13 workload is horrible for the NRC employees and I know 14 this. I have a lot of empathy for them and it's not going 15 to get better until, again, we establish some threshold 16 that's reasonable, that's based on fact, based on science.
17 Something that's clear cut that we all know that beneath 18 some reasonable dose, for example, we could choose ten 19 millorem or 100 millorem, another number that's a 20 reasonable number that is easy for us to use.
21 I had a real clear case a couple weeks ago.
22 We had -- 51 users in lab and I had people who are all, 23 something I call them, radiation cowboys because they use 24 a lot of P32, a lot of isotopes. They have about 40 25 people in their lab, but we brought in this little tiny NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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129 i 1- chromium 52 use and they all went into a panic attack.
.' 2 I had to have a meeting with up to 50 people 1
3 from tmat department telling them why this is no danger 4 and I ended up finally convincing them by calculating that 5 to get their dose limit, they would have to eat 330 '!
6 shipments of a -- each. Then they begin to realize, but 7 there were people from all over the world who again had 8 the same fear, based on our -- or no threshold and I think 9 this is the underlying thing that in every one of these 10 direction setting issues we have to look at before we can ,
11 solve the rest. And I think that once we do that,-we will 12 then have a basis for going forward and saying okay, now, 13 this is a risk, but this one is not. This program-is 14 necessary, another is not.
15 Now a way to do it, again, I will compare to 16 our audits because that's exactly what has helped us on 17 our campus. Our first two or three audits were just 18 monsters, and we did it by dividing up tasks, each staff 19 member took a part of our program and audited the dickens 20 out of it.
21 Over two or three or four years, we then 22 decided well, now, this last year now we don't have to 1
23 audit certain things so thoroughly because we know we 1
24 don't have problems there.
25 And over time, the NRC would find the same l NEAL R. GROSS COURT REPOP.TERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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130 1 thing to be true. It could enlist the help of licensees i
2 in these self assessments and these audits and )
l 3 establishing priorities. Then acting on the priorities. !
4 Thank you.
5 MR. CAMERON: Okay, thank you, Kristin, and we 6 will be getting more to that fundamental point this 7 afternoon, I think, and I would just say that no one has 8 to be apologetic in any way about talking. We encourage l l
9 people to say what's on their mind and we thank you for ]
l 10 it.
11 And we do have to wrap up here. We have about 12 two minutes or so. Tom, do you want to make a final 13 comment?
l 14 MR.-TIPTON: Tom Tipton, NEI. -
l 15 In answer to the gentleman's question of a lot l l
16 of work, not a lot of staff, et cetera, we're all in that.
17 In a competitive environment, safety is paramount to our 18 industry, obviously, so I want to put that right up front.
19 It's paramount, but we do have to make sure we're doing 20 things effectively and efficiently and cost effectively.
21 And that's why the industry strongly supports risk based, J 22 performance based philosophy where we focus on results and i
23 we use risks to make sure that we're focusing on the right l l
24 safety issues.
25 MR. CAMERON: Okay, thanks, Tom.
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131 1 Paul?
2 MR. FARRON: Yeah, I'll take a crack at the 3 last one here.
4 MR. CAMERON: Good.
5 MR. FARRON: I've heard the words consistency 6 and inconsistency here quite a bit, and I know from past 7 experience the NRC has always tried to maintain 8 consistency within headquarters and between headquarters 9 and the regions and between the regions.
10 If anything, I think we have seen more 11 inconsistencies recently in the way that the NRC does 12 business and that causes more work not only for the 13 licensees, but also for the NRC, every time there's a -.
14 And some of that may be due to some of the outside 15 activities that people have been referring to, and I think 16 you know what that is, and that goes from even the way 17 generic communications have been issued recently. It's 18 been inconsistent from what we've seen in the past and it 19 generates more questions and takes more response from the 20 licensees and like I said, from the staff as well.
21 MR. CAMERON: Okay, thanks. Well, that's a 22 great final comment here because I think as Derrick and 23 others have noted, consistency is one of the hallmarks of 24 regulatory excellence and if you have specific examples of 25 that, too, that when you follow up with written comments, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 l
132 1 that would be-very helpful for us.
t l 2 Thank you. Let's be back at 1:15. That gives
\. l
- 4 i 3 you slightly more-than an hour and.we'll start and i 4 remember we'have concurrent sessions, one in this room, l 5 one in the next room.
l l 6 (Whereupon, the morning session i-l- 7 concluded at 12:15 p.m.)
8 l-9 10 11 1 4
l 1
12 j 13 14 15 16 I l
17 1
18
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20 1 21 22 l
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133 1 A-F-T-E-R-N-O-O-N P-R-O-C-E-E-D-I-N-G-S 1
2 (1:21 p.m.) j l
3 MR. CAMERON: Good afternoon, everybody. We're 4 going to start on the next strategic arena. And this 5 strategic arena is the safe use and handling of nuclear 6 materials. ..Zmd I imagine that' we'll have some more people 7 join us in a few minutes.
8 .But let's get started with the first paper.
9 Dr. Malcolm Knapp is going to be the presenter. And he is 10 the sponsor of these papers. And the first paper that Mal I
11 will present will be oversight of the Department of )
12 Energy. We'll then go into the Agreement States paper.and 13 into the. Materials paper.
14 Mal is the Deputy Director of our Office of j 15 Nuclear Materials Safety and Safeguards. And I'll-turn it l 16 over to him for this presentation. And if you're 17 interested in the research or international papers, they 18 are being done in the room next door.
19 DR. KNAPP: Thanks, Chip. I should begin by 20 telling you two down sides about this paper. First is 21 that Chip was my co-author. But despite that, the paper 22 is still a very good one.
23 The other is that the lady running slides is 24 Clare Defino. Clare has worked closely with me on all of 25 the papers you'll hear this afternoon and the waste papers NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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134 i
l 1 tomorrow. We flipped a coin over who would talk. I wound l 2 up getting to do it. She won.
3 To move to this particular issue, our i
l 4 oversight over the Department Energy, the specific issue 5 is, should the NRC seek to expand its regulatory authority I
6 and responsibilities to include DOE facilities. Let's l l 7 emphasize the word " seek." How did this issue arise?
8 And I think probably most of you are pretty 1
9 familiar with DOE. I suspect you're familiar with the 10 size of the organization. They've got laboratories. l l
11 They've got full-size nuclear reactors. They've got test I
12 reactors. They have all kinds of cleanup efforts. And ;
l 13 for those of you.that had a chance to look through the !
l 14 paper carefully, there a host of things that the DOE is 15 involved-in.
16 And DOE is now largely self-regulating. Now, ,
1 17 there is some regulation, by the NRC actually. The high l
18 level waste facility that they're developing is one we're i
19 regulating. The remedial action they're taking on some I l
l 20 milltailing sites is regulated by us. And they also have' )
21 -- the EPA has generally applicable environmental ~
22 standards which DOE'must meet. But by and large, DOE l
23 regulates itself. ;
24 A couple of years ago, questions began to l
! 25 arise as to whether it would be wise to have an external NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE (SLAND AVE., N.W.
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135 1 regulator of DOE to improve safety and to improve the 2 credibility of that agency's efforts. These questions 3 were being kicked around in Congress and in part, in 4 response to this, I'd say the better part of two years l
5 ago, Secretary O' Leary put together an advisory committee 6 on the external regulation of DOE nuclear safety.
7 That committee completed its activities in '
8 December of last year and reached a-number of conclusions, 9 basically that it would be appropriate if DOE were 10 regulated externally, and that although they did not make 11 a decision, they suggested that an existing agency would 12 be appropriate. One alternative would be the NRC. ;
13 Another would be the Defense Nuclear Facility Safety
.14 Board. That would have been a restructured board from 15 what'the current board is.
16- Given that this issue is present and that this 17 could have a dramatic impact on the Nuclear Regulatory 18 Commission, the question was raised, should we take a 19 position on this. And with that question, there were a 20 number of key factors that we identified.
21 First, we could wind up with broad oversight 22 over the Department of Energy through congressional 23 action. Simply change the law so we would be responsible 24 for some, most or all of the current DOE activities.
25 However, even without congressional action, the NRC's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS ,
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136 1 oversight of DOE is increasing. There have been a number 2 of DOE initiatives and some congressional initiatives 3 which on an incremental basis have changed our oversight.
4 For example, the 1992 law which gave us 5 responsibility for the U.S. Enrichment Corporation's 6 gaseous diffusion plants. DOE's current activities in its 7 Hanford tanks, where we are this year funded to give them 8 assistance and may after several years, should DOE 9 privatize, NRC would be the licensing organization.
10 There are a variety of other activities that 11 as DOE shifts into privatization or different approaches, 12 existing law could cause the NRC to get additional 13 responsibilities. I think you're all aware that DOE is a 14 pretty big outfit. They've got over 3,500 nuclear 15 facilities in 13 states and tens of individual locations.
- .6 One of the concerns that we would have if we 17 were to take on this work would be resources. As you 18 know, I think, the NRC is a full fee recovery agency.
19 That means that we recover our fees from our licensees.
20 They're appropriated by Congress, but nonetheless, we are 21 supposed to recover approximately 100 percent of our 22 budget from licensees. If we were to take over DOE, the 23 question comes, how would we be funded to do this. This 24 could particularly be an interesting question if our 25 incremental oversight of DOE increases and provision is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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I 137 '
l i 1 not made in Congress for how that work should be funded. l i
2 Finally, and perhaps most important, were we 3 to regulate DOE, we would require considerable additional 4 resources. The NRC today has a staff of a little under 1
5 3,000. We have a budget of around $475 million. Should l 1
6 we achieve broad responsibility for the Department of l 7 Energy, our best estimates are that it would take 1,100 to .
l 4 8 1,600 additional staff and perhaps $150 to $200 million to
) 9 be able to do this. That represents a 40 to a 60 percent 10 increase in the NRC's current size, with corresponding 4
, 11 workloads on staff, on the Commission itself, need to 12 develop or modify a broad range of regulation. So it 13 could have a tremendous impact should we wind up with this
- 14 responsibility.
15 Given these factors, the Steering Committee 16 brought four options to the Commission. We could support 17 broad responsibility for NRC regulation of DOE. We could 1
18 do this in several ways. If you've had a chance to look 19 at this, you'll notice there are some suboptions. We 7
20 could simply seek responsibility.
j 21 As the DOE Advisory Committee suggested, an 22 external agency might do it. But those suggestions were a 4 23 little different from the current structure that EPA has -
) 24 - excuse me, the NRC has with EPA and with OSHA. Perhaps i
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138 1 current division-of responsibility with the other agencies l 2 that are now involved in DOE and in commercial nuclear l
l 3 facilities.
l 4 Another alternative would be that we might try 5 to take the best of both worlds. For example, for years 1
6 we and EPA have been struggling with how best to deal with ,
l 7 mixed wastes. While it might be a good idea to maintain .'
l 8 our current commercial regulatory structure were we to 9 oversee DOE, perhaps we should try to work something out .
10 with the other agencies to solve some of the existing 11 problems.
12 Another alternative would be that we could l 13 take on broad responsibility for regulating DOE, but only I
14 for certain types of facilities. For example, we might 15 say that we want to regulate non-defense facilities only.
16 The third alternative would be that we would l
17 just oppose taking on additional responsibility. We could 18 argue that this broader responsibility would reduce the 19 Commission's focus on safety of current commercial l 20 reactors and current nuclear materials users, and that we 21 already have all the responsibility that we should take 22 on.
I L 23 Finally, as a fourth option, simply take no l
l 24 position. Now again, recognize these are positions that 25 we would take. What may happen in the future will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND A'd., N.W.
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139 1 obviously be directed by, among other things, 2 congressional action. And should Congress give us part or s
3 an entire mandate to regulate DOE, we will do the best of 4 our ability what we can. The question here is, what J
e 5 should the agency's policy position be on this issue.
l 6 Well, with these options in front of us, the i
7 Commission decided that they preferred the fourth 1
8 alternative. They would not take a position on whether or 9 not DOE should be regulated by the NRC. The Commission 10 does feel that if we had adequate resources and a 3
11 reasonable time table to develop a program, we could 12 provide adequate regulation if we were asked.
, 13 Our view is that, therefore, if we were to be i
t
- 14 given this oversight, we would like to get it on an
- 15 incremental basis, and we would seek some method of 16 prioritization so that as we took on this responsibility, 17 we could address first the areas which would have the most 18 cost benefit from a safety perspective.
, 19 That's the issue and the Commission's i
20 preliminary view. And now, with Chip's help, I would like 21 to hear what your viewc are on the topic.
4 22 MR. CAM'ERON: Okay. Thanks a lot, Mal. If 23 you people in the back of the room are bothered by the 24 noise from over there, please feel free to come up here to 25 the front. And I think it would be less interference for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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140 1 you, if you want to. Just move up if you have to.
2 As you can tell, this is a major issue for us, 3 oversight of DOE, and I guess one place to start is, is it 4 relevant to ask whether anybody believes that DOE does not 5 need an external regulator? I won't take silence for an 6 assent that they do. Perhaps no opinion on that.
7 How about this whole issue? Someone want to 8 start us off with some discussion on external regulation 9 of DOE? Steve?
- 10. MR. COLLINS: Stephen Collins with the 11 Illinois Department of Nuclear Safety representing the 12 organization Agreement States. With regard to your first 13 question and followup, specifically on page 15, the second 14 and fourth paragraphs on that page of this DSI, it 15 indicates there's a recommendation that de, contamination be 16 excluded from the regulator's purview. And we disagree 17 with that. Decontamination should not be excluded from 18 the regulator's purview. And the following is from 19 Chapter Five of the report issued by the ACER of DOE 20 safety.
21 "We have listened to many days of testimony 22 and have deliberated among ourselves for almost a year.
23 We conclude that every major aspect of safety at DOE 24 nuclear facilities, facility safety, worker protection, 25 public and environmental protection all should be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l l 141 1
1 externally regulated."
2 Agreement States agree with that.
l 3 MR. CAMERON: Okay. Thank you, Steve. One of 4 the cautions and I don't think I'm stepping too far 5 outside of my facilitator role here, but one of the 6 cautions that I would give to everybody, myself included, 7 when reading the external regulation of DOE Advisory 8 Committee report, is that it can be a little bit tricky 9 sometimes. And it's, to me at least, unclear about 10 actually what they may have been recommending in some 11 cases. And I won't turn to our resident expert yet on 12 this. Okay? But that's a good point about whatever they 13 said decommissioning should be included.
14 Mal, do you want to comment?
i 15 DR. KNAPP: Only that NRC was not intending to 16 comment on whether any of these aspects should be 17 externally regulated. I think the question might be, if 18 they are, would decontamination fit best under the purview 19 of the NRC or the NRC working with the EPA or perhaps the 20 EPA alone.
21 My interpretation of the paper, and I'm 22 perfectly willing to hear others, was that we would h:ve 23 had the role of what I think they called the facility 24 safety regulator. And I was not clear on whether that 25 role would include responsibility for decommissioning or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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142 1 not. In any case, the question of whether they should be l 2 externally regulated with respect to decommissioning, and 3 if so, would that be a better role for the NRC or someone j 4 else, certainly is an area where I'd be delighted to hear 1
5 any comments.
1 l
6 MR. CAMERON: Steve? l i
7 MR. COLLINS: Stephen Collins. What we were 8 trying to clearly say is that we thought out of all of the l I
9 agencies available, the NRC was the agency that should i l
10 provide that independent regulatory oversight for !
11 protection in all aspects of the decontamination, i 12 decommissioning effort. !
l 13 DR. KNAPP: Thanks. j i
14 MR. CAMERON: How about comments on the :
I 15 options. Mal presented four options. And as he pointed l 16 out, at least their preliminary view is the fourth, take 17 no position on broad NRC responsibility. Now, we've been 18 hearing in other sessions, some people support the first 19 option. In other words, a more aggressive approach on 20 assuming regulatory authority.
21 Do we have any comments on the first option?
22 In other words, should the Commission really go after 23 this? Kristin?
24 MS. ERICKSON: My comment on this issue should 25 be weighed according to the fact that I'm not a DOE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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143 1- facility. But I do have a strong view on that because we 2 have to interact with DOE facilities a lot. And in fact, 3 our worst nightmares in regulatory and paper trails and 4 working together with an agency is with DOE and EPA. I am 5 very much -- our institution is very, very much against !
6 EPA being involved in any radiation things. And I do base 7 that on experience.
8 Having had to work-with them on the NISHAPS 9 thing for two years, documenting that we were exempt when 10 they already knew MSU was exempt from their own two !
11 studies, they refused to accept that. My staff and I 12 spent literally hundreds of hours coming up with methods 13 and documentation, methodology which wasn't reasonable, l
14 plus explaining basic radiation things to the EPA. And in 15 the end, I also did a survey of about 15 broad licensings ;
16 in our own region and determined that we all were told I
17 different answers to the exact same question. So we don't 18 want EPA involved in any radiation thing if there's 19 anything we have to say about it.
20 As far as the NRC taking over DOE, I think 21 that's an excellent idea because of all the agencies that 22 we are aware.of, the NRC is doing the best job of trying !
I 23 to self-improve. It has a long history of regulations, a 24 long history of experience with the public and the :
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144 !
l 1 prioritizing, I think that's a good idea, too. j I 2 MR. CAMERON: Okay. Thank you, Kristin. Let 3 me just ask one clarification. You would recommend that
)
4 the Commission select option one, then?
I I 5 MS. ERICKSON: I would recommend they select '
i
! -6 option one. And then within that framework, do the same ,
7 thing we're talking about doing with all of our licensees, '
l . u l 8 risk, analyze and then prioritize.
9 MR. CAMERON: Okay. And thank you. And there j i
10 will be a special seminar in the Sports Bar tonight on -
i 11- subpart'I. And it's sad that we're-all laughing, because 12 that's such an inside joke that hopefully no one would be.
13 But I guess we all have experience with'subpart I, don't 14 we? !
15 Yes? l 16 MR. WILLIAMS: Jim Williams, the State Liaison 17 Officer of the NRC from Ohio. ;
18 As a state that has a significant -- a series 19 of significant problems and installations that DOE has 20 been operating, particularly Fernaud and.the Gaseous 21 Diffusion Plant, which was mentioned earlier. We have ,
22 seen a difference in the relationship and operation at the i
23 Gaseous Diffusion Plant eince the NRC has been interacting 24 with the United States Enrichmer.t Corporation. And it l 25 would give us a basis to believe that NRC should interact l
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145 1 on a more broad basis in regulating the DOE facilities.
2 And I agree with Kristin, because the EPA has functions 3 for the Fernaud cleanup and there are differences of night 4 and day between the relationships of those two facilities. )
5 It would appear that we would favor some broad 6 support and responsibility for regulating certain types of 7 DOE facilities, and I agree that perhaps the defense 8 facilities may be best left to DOE because of their 9 long-standing relationship with that program. But 10 certainly as we emerge from a defense-oriented production 11 process, it would appear that some of those DOE facilities 12 could best be regulated by an external source.
13 As far as some of the costs, DOE is 14 self-regulating. And as it self-regulates, it doesn't do 15 that for a zero sum. It has to spend some money in its 16 self-regulation process. It would appear that 17 consideration could be given to charging DOE the same type i
18 of fees that NRC charges other governmental agencies and 19 other private industries to do the regulatory process. l 20 And that would offset some of the costs now to -- that 21 you're discussing. Maybe not the $150 million worth, but 22 a substantial portion of that that DOE might be paying now i 23 that they could use to offset the NRC's efforts.
24 MR. CAMERON: Thank you very much, Jim. Mal?
25 DR. KNAPP: Appreciate the comments. We have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., NW.
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146 1 a couple of budget folks who can speak better than I to 2 the subject, but in the interest of brevity, I'd say that 3 if we were to take broad responsibility for DOE, we would 4 have to have a way to be compensated. The agency could 5 not tolerate its current budget. Our interests -- there's 6 a number of ways we could do it. Congress could just give 7 us the money and say you don't have to get it back from 8 DOE, or Congress could say you have the authority to take 9 it from DOE, whatever.
10 Our principal interest would be in ensuring 11 that we did not work a financial hardship on our existing 12 commercial licensees and that we had enough growth that we 13 could maintain the safety responsibility we now have while 14 taking on the additional work.
15 Given that we were to be given broad 16 responsibility, I would like to think Congress would help 4
l 17 us work out a way that we could fund it in an equitable '
18 way. I 19 MR. CAMERON: Thanks. That was a good 20 observation on your experience in terms of the Gaseous 21 Diffusion Plant there and it raised a couple of issues 22 that Mal touched on in terms of key factors that the costs 23 of regulating DOE, not only dollar cost but the number of 24 staff, properly trained staff. You raised the defense 25 facility issue. That was one of the things that I think NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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147 1 1
1 was flagged in the paper, is how would we' deal with that l j
2 national security type of issue.
i ,
3 And I guess I would ask the audience, and 1
5 4. also, you, Jim, what about the role of the states in this. l 5 whole scheme, if we were going to go to external 6 regulation. And, Steve, I don't know if you wanted to 7 address that at this point along with your other comments 8 or what. But if you do, fine.
9 MR. COLLINS: Stephen Collins, representing 10 the Illinois Department of Nuclear Safety and the 11 organization of Agreement States. Don't let me leave that ,
12 out when I get there, but I want to make a few short 13 remarks first. ,
14 We believe the NRC's best approach might be 15 characterized as a mix between options 1B and option four.
16 The initial stance should be that defined in option four, I
17 but the NRC should go forward with option 1B. Illinois 18 and the other agreement states may want to assume this 19 authority, if that option is available. We know that 20 there's a precedence under other EPA type regulation where 21 states are in fact doing that. And Tennessee and 22 Washington have in fact expressed a specific desire to do l 23 that already. And I think Colorado has also.
24 We also think that the NRC should actively i
25 participate with the Conference Race Control Program, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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148 1 directors E5 Committee on Low Level Reactor Waste that has 2 the task to evaluate various options available and to 3 develop a regulatory strategy for the DOE facilities that 4 does not create a new mess for the future. )
5 That's partly specific about the fact that NRC l
6 does have representation on that committee, I believe, but
-7 they didn't show up for the last meeting. Maybe not the 8 one before that, but certainly not the last meeting.
9 That's all.
10 MR. CAMERON: Okay. I think it's worth -- one 11 point of emphasis is that the view from the Agreement l l
1 12 States is that, and for people to keep this in mind, if j i
13 NRC assumed external regulatory authority over DOE, that 14 the Agreement States would like to share that authority 15 under some arrangement, although there'is many ways to do ;
16 that. But that was an important point.
17 And as a matter of clarification, I don't know 18 if Mal or Steve knows, and Steve Crockett in the back, 19 about our represent -- were you saying that we were on the 20 external? ES, okay. Okay. And the E5 Committee 21' basically deals with what?
22 MR. COLLINS: Low level waste.
23 MR. CAMERON: Okay. And is there also a i'
24 Conference of Radiation Control Program Directors 25 Committee that is specifically on the regulation of DOE l
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149 1
1- facilities?
2 MR. COLLINS: No. There's not a specific 3 committee on it, but they do have a person authorized to 4 speak for the conference on that. And that's the 5 representative from Tennessee, Mike Mobley.
6 MR. CAMERON: Okay. Good. And Mike was also 7 a member of the External Regulation Advisory Committee.
8 Roger?
9 MR. HUSTON: Roger.H;ston from NEI. The 10 principal interest that the civilian nuclear industry, 11 represented by our members, has in this arena is, as has 12 been mentioned before, it's going to be expensive. And 13 I'm happy to hear Mal talk about equitable ways that that 14 funding needs to be provided rather than providing it 15 through an increase in fees on existing licensees.
16 I do want to express one logical caution, 17 though. It makes some sense that there are resources 18 being expended at DOE in self-regulation, which, if they 19 were externally regulated, could be moved over. But that 20 may not be the end of the problem. At least one of the 21 drivers for this -- look for external regulation of DOE, 22 is a perception in'at least some quarters that they're not 23 doing enough. And if that perception is accurate, then 24 what that means is a transfer of all of the resources that 25 DOE is now using to regulate itself may not be enough to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.
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150 1 cover the additional effort that has to be put in by NRC 2 or someone else. So it's not just a zero sum gain.
3 DR. KNAPP: I might, in response I might note 4 that in our estimates that you heard earlier, the 1,100 to 5 1,500 and so on, 1,100 to 1,600, our basis for those 6 estimates was to look at DOE facilities that to the best i 7 of our knowledge closely resembled facilities which we now 8 regulate. And our estimates were basically, this is what 9 it would cost the NRC to do the job the way we now do it 10 for' commercial facilities. I would suspect those are 11 probably higher than what DOE currently applies. So 12 you're right. It will not be a zero sum gain.
13 MR. CAMERON: Anybody else wanted to express 14 an opinion on any of these issues but to followup on 15 Roger's point, the whole effect on the commercial side of 16 NRC regulation? Roger gave an example that's an obvious 17 point, which is don't have us pay for it. What about the 18 quality of regulation issue? I think that's one of the 19 factors flagged also in the paper, is that the NRC would 20 just be so overwhelmed, possibly, by taking on 21 responsibility that the quality of regulation of the l 22 commercial side would also go down. Any comments on that? !
l 23 Okay.
24 MR. FRAASS: Ron Fraass, Kansas Radiation 25 Control. The general area of that one that I'd pulled out NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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151 l 1 was on'page 17, where the DSI talked about the history and 2 size of DOE nuclear facilities and programs may make it
. 3 very difficult for that agency to provide sufficient 4 resources and technical expertise to be able to maintain ,
t l 5 the same standards NRC sets for comparable commercial- l 1
i
{' 6 licensees. I think that was the point that was being i .
7 made. That one concerned me as for option four to be the 8 preliminary choice.
9 If the NRC's current standards are the 10' appropriate minimum to ensure adequate' protection of
. 11 public health and safety, promote common defense security l 12 and protect the environment, NRC's goal statement, why ;
i 13 should potentially less stringent standards apply to DOE.
i
- ~ 14 In an earlier life in the Air Force, I. worked a lot with 4
i 15 the DOE. And basically every contractor that they had' set -!t 16 their own set of standards and then tried to maintain ;
17 them. I did not see any real external set that applied 18 broadly within the Department of Energy.
19 MR.' CAMERON: That's also a good point that I ;
20 think-ties in with some of the down sides here, is that i 21- what would be the implications of having basically two 22 different regulatory regimes, if that actually was the 23 consequence. And I think that goes to Kriscin's point 24 also about one of the things referred to in this paper was 25 the relationship between NRC and EPA in regard to any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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152 1 future regulation of DOE. There is also issues of would 2 the NRC take over regulation of NARM. And if you do it in 3 a DOE sector,-what are the implications of that for the 4 commercial sector. And now we'll go to Gordon Appel.
5 MR. APPEL: I am Gordon Appel. I'm Deputy 6 Director of the Department of Nuclear Safety. And I just 7 want to clarify two things.
8 Chip walked around the issue of states and the
?
9 authority relative to regulating DOE a little bit. I 10 don't know about other states. I can only speak for 11 Illinois. But in the perspective of Illinois, it's our 12 view that we would want the authority to regulate the 13 Department of Energy the same way we regulate other 14 materials licensees.
15 And secondly, you mentioned in your last 16 statement something that.might have been a little bit 17 confusing. Are you suggesting that one of the approaches 18 to external regulation of DOE would be to somehow regulate 19 them to a different set of standards than the current set 20 of standards of materials licensees in the country?
-21 MR. CAMERON: No. I'm not suggesting that 22 that's what would happen, but it's been expressed that one 23 of the fears was that NRC might, and picking up on Ron's 24 comment, is that we might not be able to apply the same 25 stringency of standards to them. And that would be one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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153 1 thing that might prevent us from assuming regulatory 2 authority or it might be one down side.
3 And Mal, do you want to amplify on that to 4 perhaps clarify what I was trying to say? And then we'll 5 go back to Gordon.
6 DR. KNAPP: I think the. concern as expressed 7 is that the NRC and its-Agreement States hold their 8 licensees to very high standards. For better or worse, 9 partly because of the decade's long history of DOE, there 10 are facilities which don't meet those standards, or at 11- least the supposition is they wouldn't. And the 12 supposition is it would take a great deal of resources to 13 bring them up to those standards.
14 So if we were to take over regulation of DOE, 15 it's been supposed that it would be difficult and ,
16 time-consuming before we had Department of Energy i 17 facilities meeting the same standards that our commercial 18 facilities meet today. And I think that's basically --
19 it's a recognition that we are not going to take over 20 regulation of DOE tomorrow and the day after they meet 21 every standard that the commercial-facilities meet. It 22 will take probably years. Excuse me, it will certainly 23 take years. The question is, how many years.
24 MR. APPEL: Thank you for the clarification.
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154 1 that. I think anybody who looks at the history of that 2 agency and your own agency would understand that.
3 DR. KNAPP: I think the challenge should be, l
4 and maybe I should go a litCle further. Given that that's l 5 going to be the case, how do we progress through these t j 6 years? Is there some sort of a growth pattern that we l
l 7 would need to define as DOE comes closer and closer to 8 achieving our existing standards? If we are given this 9 responsibility, it will be quite a challenge.
10 MR. CAMERON: Yes?
11 MR. WITTSCHEN: Ron Wittschen. I'm with 12 Detroit Edison. Also in a former life I worked at a DOE 13 facility. And I believe that the resolution would be to 14 meet the intent of the regulations. Having been at these 15 1950 facilities, there's no way in the world they're ever 16 going to comply strictly to the letter that commercial 17 plants meet. It would have to be a negotiated design 18 basis that they would have to meet, you know. Based on
-19 where they are now and the best available, you know, 20 improvements that they could mske. That would have to be 21 the final product.
22 MR. CAMERON: Are you suggesting that it's not 23 just a question of timing, that it may actually be that 24 there would be a difference in the regulatory regimes l
l 25 between commercial and defense or?
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155 i 1
1 MR. WITTSCHEN: Not necessarily a difference 2 in regimes. Probably not a whole lot different than 3 applying a brand new regulation to a very old plant.
l 4 MR. CAMERON: Okay. Okay. Thank you. Thank )
5 you for that clarification, i 6 Gordon, do you have anything else on this?
7 Anybody want to say anything more on the Department of I i
1 8 Energy issue?
9 I guess I would just ask Gordon one question.
10 In terms of the state rule in regard to the DOE 11 facilities, would it be to follow the Agreement States i
12 model where certain types of facilities are excluded with l l
13 NRC setting some overall regulations, or are there l 14 different modes to follow? And I know that this is 15 something that may be a little bit unfair because you l 16 haven't had much time to think about this. But I was )
17 really just curious about what your thoughts were on it?
l 18 MR. APPEL: Well, you're traditionally unfair, 19 Chip and I have known each other for a long time, and we 20 appreciate each other's unfairness. But we haven't put a 21 great deal of thought into it. You have to understand, 22 the State of Illinois is a whole lot different perhaps 23 than some other Agreement States. I mean, we don't have a 24 major weapons production facility in the State of Illinois 25 for the DOE. And I think that makes a big difference.
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156 1 From our perspective, however, with the 2 exception of a few things that relate to safeguards and 3 criticality type considerations, I think that we would 4 apply the set of rules that we have for materials and 5 accelerators and that sort of thing directly to DOE 6 facilities in the State of Illinois.
7 MR. CAMERON: Okay. And I thought I saw an 8 affirmation from Kansas. Kansas affirms that. And how 9 about the State of Ohio? Do you have any views on that, 10 Jim? I know you're not an Agreement State, at least not 11 yet, but this doesn't necessarily need to fit into the 12 Agreement State regime either. But if you have any 13 comments, please feel free to add them.
14 MR. WILLIAMS: Well, I think the issue on 15 safeguards versus nuclear safety, the safeguards in 16 security issue versus the safety issue is one that needs 17 to be dealt with if NRC were to exercise any of the 18 options other than four, because the DOE has an 19 established system that's worked for a number of years in 20 the safeguards in the security process. And even at the 21 Gaseous Diffusion Plants, they still have the security and 22 safeguards program, although they do have a contract, 23 USEEC, to work at the plant in Ohio.
1 24 And there I think they're looking at more in !
25 terms of what happens in the autoclaving process and on i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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157 1 the safety processes internally within the plant, which 2 are totally different than the safeguards in security
. 3 issue. So I think DOE's ability to do safeguards in 4 security should be recognized on any of those three, first F
5 three, should they be adopted.
6 MR. CAMERON: Okay. Thank you. And I believe i
7 -- and Steve maybe would want to clarify on this. I 8 believe that the External Advisory Committee did recommend j 9 that at least for the initial phase-in that DOE would keep 1
10 its safeguards system and the NRC would not assume that.
11 And Steve is shaking his head affirmatively on that one.
12 Do we have any other comments on the DOE issue 13 before we move on? Okay. Mal, do you want to go to the 1 14 next paper? Okay. We're going to go to the Agreement !
15 States paper.
16 DR. KNAPP: Okay. Direction setting issue
~
17 number four is our relationship with Agreement States. I l l
18 believe there may be some folks in the audience today that l 19 have an interest in this particular issue. The specific 1
- 20 issue is, what should be our strategy regarding states
~
21 becoming and remaining Agreement States. !
22 I'd like to note'in passing that two weeks ago 23 yesterday, the NRC met with a number of Agreement States.
l 24 We've got a lot of good comments. It was a very 25 constructive meeting, and we were pleased to have it.
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158 l
1 There are a number of factors that need to be 2 thought about in our relationship. As has been mentioned j 3 earlier today, about 70 percent of the licensees, I
J 4- materials licensees, in this country reside in Agreement 5 States. NRC's got about 6,500. .Th e Agreement-States have 6 about'13,000 or so. It's also true, the general -
1 i
7 licensees,~where we've got about 35,000, and the Agreement _
i
- 8 States have about 100,000. And right now we have four j 9 states'which are not Agreement States which are either
-10 negotiating or very actively pursuing Agreement States Li 11 status. If that happens, the number of NRC licensees, as 12 I mentioned a' moment ago at 6,500, would drop by about a j 13 ~ third, to about 4,500.
14 This is of concern because of the Omnibus
'l' 15 Budget Reconciliation Act, which requires us:to' recover 16 all-our fees. Excuse me, requires us to cover our budget 17 from our licensees. And as the NRC's licensee numbers 18 decrease and decrease and decrease, we begin to ask, what 19 should be'the budgetary arrangement with.the Agreement-1 20 States. And we see this as putting increaced pressure on 21 us to minimize our financial support to Agreement States.
And an area that has been, frankly, !
22
'23 contentious over a couple of years-is the extent of which- l 24 NRC should provide the financial resources for Agreement 25 State training and for travel to that training.
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159 1 The last bone of consideration is the NRC's 2 obligation to oversee the Agreement States Program. As 3 most of you know, when we find an Agreement State to be 4 adequate and compatible, we relinquish our authority to 5 them, but we do retain a responsibility of oversight of 6 the program. And the best way to do that is certainly a 7 factor we need to consider in our relationship with 8 Agreement States.
9 Given these factors, the Steering Committee l 10 brought five options to the Commission for consideration.
11 One, turn the Agreement States Program over to the 12 Environmental Protection Agency. Well, why would we want 1
13 to do that? Well, EPA has an Authorized States Program !
14 right now. And arguably, some Agreement States might be 15 most comfortable -- excuse me, some states might be 1
16 comfortable dealing with a single federal agency rather 17 than having to work with two. Of course, an adverse 18 impact of that would be the EPA is principally concerned 19 with the environment and would have to develop some sort 20 of a material safety effort should they be given this 21 responsibility.
22 Second option. Strongly encourage states to 23 become Agreement States. Provide tangible incentives.
24 Provide the money for training and for travel to that 25 training. Provide seed money for states that might look NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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160 1 to become Agreement States. Provide intangible 2 incentives. Strengthen the role of Agreement States in 3 the development of NRC's regulatory decisions. Have 4 commissioners actively pursue governors and legislatures 5 of states to encourage them to become Agreement States.
6 Third alternative. Continue the current 7 program, including adopting current initiatives. The 8 Agreement States Program today is not static. It's in 9 flux. We have initiated policies which the Commission has 10 under consideration which hopefully would provide a better 11 balance between flexibility and compatibility. We have an 12 IMPEP Program, that's Integrated Materials Performance 13 Evaluation Program, which was initiated not too long ago 14 and which is still developing. So that to continue the 15 current program, we would like to think, would result in 16 improvements and a better relationship with the states 17 than we might have had a few years ago.
18 Another alternative. Create the American 19 States as co-regulators. We're all in this together.
20 Everybody has an equal share. Everybody has an equal 21 responsibility, including funding.
22 Last one. Evolve regulation of AEA 23 Section 274 materials to the Agreement States. This would 24 be the NRC gets out of the business. This might, 25 depending on how we do it, it might involve seeking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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161 !
1 legislation from Congress to do it.
2 Arguably, the states have the basic 3 responsibility for the health and safety of their 4 citizens. They do this well in a number of areas.
i 5 Arguably, we should simply say 40 years ago, when we 6 didn't understand nuclear materials, it made sense for the 7 feds to have a major role. Now, we. understand them pretty 8 well. We have programs in place and the states might be a 9 lot happier being allowed to do this as they see fit.
10 As we talk about these options, I would remind I 11 you that these are, as Jim Williams mentioned earlier 12 today, out of the box thinking. One or two are probably 13 provocative. We're interested in your comments. We're 14 also interested in your comments on chunks of options.
15 You may find part of one option good and another part 16 intolerable. We'd be happy to hear how you might find a l
17 combination of options or pieces of options most 18 attractive.
19 When we provided this to the Commission, their 20 preliminary views were that they wanted to continue the 21 current program, including the initiatives. They wanted 22 to encourage more states to be Agreement States, but they 23 wanted to use non-monetary incentives, although they were 24 prepared to explore the idea of using seed money. They 25 would try to provide training to states in a limited way NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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162 1 by giving them training without charge on a space l
\
2 available basis, but states would have to provide their 3 own funding for travel.
4 The Commission has a number of questions with
- 5 this issue paper, so it particularly seeks comment.
6 Certainly, because of the interest in the issue, we'd like 7 to hear from whether NRC should fund training, travel and 8 technical assistance. And in this area, we particularly 9 would like to hear from, obviously, Agreement States, but 10 non-Agreement States, Agreement State licensees and 11 non-Agreement State licensees. What we're trying to do 12 here is strike the most equitable balance we can among 13 everybody involved and so we'd particularly like your 14 comments on this issue.
15 With that, I see Chip picking up his 16 microphone, and I'd like to hear your thoughts.
17 MR. CAMERON: Okay. Thanks, Mal. And that 18 last statement of Mal's was particularly important. Is 19 that, when you take a look at these options, it may seem 20 that they're within the province of an Agreement State to-21 comment on, but keep in mind that there's a lot of issues 22 that have the licensee communi*, and the public wrapped up 23 in here, including the burden, if that's what it could be 1
24 called, on licensees for funding the Agreement States 25 Program. Whether a particular licensee would rather be l l
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163 4
1 under an -- in an NRC state or an Agreement State, the 2 whole question about national uniformity, flexibility and 3 regulation, all of those issues.
4 And I guess would cast it open here for an 5 initial comment on the issues. And let's go to Steve 6 Collins.
7 MR. COLLINS: Stephen Collins with the 8 Illinois Department of Nuclear Safety and representing the 9 Organization of Agreement States as well.
10 I'll try to hit every one of those in the next 11 four or five minutes. Illinois and the other Agreement 12 States should be treated as partners or co-regulators.
13 That's an expression that comes in option four. In an 14 effort to protect health and safety from radiation in the 15 United States, the statute which created the Agreement 16 States Program recognizes the growth of the states and 17 their eventual assumption of a co-regulator status.
18 Agreement States are fully capable of participating with 19 the NRC in determining the shape of the program.
20 Only option four states that "the Commission 21 would recognize the experience that lies within the 22 Agreement States." This recognition should occur within 23 the NRC regardless of the chosen strategy option. The 24 NRC's ideas presented. in option four are in direct 25 contrast to the views recommended in the other DSI's where NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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164 1 cooperation with professional societies, international 2 agencies and licensees is stressed. ,
i l
3 We propose that the NRC transform its l l
4 traditional view of the NRC-Agreement State relationship )
5 into strategic partnering. The relationship is less donor ,
6 helping recipient. The relationship would be more equal 7 and cooperative. And this idea is taken directly from the !
i 8 last paragraph on page 13 of the DSI 20, International j 9 Activities. ,
l 10 With the above in mind, we favor continuation ;
)
11 of certain programs developed in partnership with the l
12 Agreement States and presented in option three,.especially .
13 the IMPEP and the Adequacy and Compatibility Policy 14 Statement as revised by the Agreement States on 15 September 19, 1996.
16 Option three is the Commission's preliminary i l
1 17 choice. In addition, NRC should recognize the many 18 benefits that are received by the NRC and its licensees 19 from the states and return to funding of training, travel 20 and technical assistance. The use of intangible l 21 incentives to encourage more states to become Agreement 22 States as well.
23 And with regard to your statement on equal 24 responsibility for funding as stated in option four, the 25 many benefits that the NRC and its licensees receive from NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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! 165 i
1 Illinois and the other Agreement States without 2 reimbursement were conspicuously missing from this DSI.
3 They include the. Agreement States regulate all the 4 commercial, low level waste disposal facilities. And the 5 Agreement States are in the process of licensing.all the 6 new commercial low level waste disposal sites. And.while 7 thisEis going on, the~open sites and Agreement States
! 8 continue to rective waste from the NRC licensees as well
}
9 as from the Agreement State licensees. That's a definite
[
10 benefit and worth something in exchange.
! 11 Illinois and the other Agreement States 12 respond to incidents involving transportation of NRC 13 licensed material within their jurisdictions, particularly r
14 those involving interstate carriers. That's a benefit to i
i 15 the NRC and their licensees.
16 Many Agreement States provide salaries for 17 their staff.to participate in NRC IMPEP reviews and
) J 18 Agreement States and NRC regional offices. Illinois and i
- 19 other Agreement States staff are lecturers at NRC j 20 sponsored training courses without payment of their salary j J'
- 21 and for the Agreement States' staff time.
l
- 22 Illinois and other Agreement States develop l 7
- 23 many rules that benefit the NRC, industrial radar !
l i 1 24 certification and draft changes to licensing requirements 25 for licenses of broad scope that were developed at state
.g --
L _
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166 1 expense and provided to the NRC without any compensation.
2 Illinois and other Agreement States have l
3 conducted surveys and assisted in the removal of byproduct 4 material from facilities at the request of NRC. Illinois 5 and other Agreement States are currently investigating 6 potentially contaminated sites for licenses that the NRC 7 possibly terminated inappropriately. Illinois and other 8 states monitor the environs of nuclear power plants and 9 other nuclear fuel facilities licensed by the NRC in order 10 to confirm the validity of NRC licensees' environmental 11 monitcring programs and to confirm that releases is rare 12 to the environment are in compliance with the limits, with 13 only partial compensation. According to NRC staff, that's 14 about 33 percent.
15 There are some other considerations that have 16 been omitted from this DSI. The NRC did not acknowledge 17 that it would do most of the work on regulation 18 development even if there were no Agreement States. So 19 the document's misleading in that aspect. There was 20 missing an evaluation of the health and safety impact for 21 each option. And that should definitely be included, as 22 that.'s a primary reason for NRC's existence. So the l 23 health and safety considerations for each option should be 24 included.
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167 1 reestablishing the historic Agreement States Program where.
! -2 NRC funding for all training courses for Agreement States 3 staff that included course tuition, travel expenses and i 4 per diem. And that was the case up until a year -- well, 5 prior to October 1st, actually. The advantage for NRC and 6 the states with this method of training was that both 7 Agreement States and NRC inspectors across the United i
- I 8 States receive the same training, which helped assure
[ 9 uniform implementation of a uniform regulatory program, i
! 10 fairly uniform. The NRC new reg, 13-11, entitled Funding I
- j. 11 the NRC Training Program for States, recognizes the j
' 12 benefits of the historic program. On page two, it states, i
- 13 "The NRC Agreement States Program has been reviewed by the i.
14 General Accounting Office, an internal NRC task force and l 15 the National Governors Association. In their reports, the l 16 NRC Training Program for States was consistently l
! 17 identified as a key to establishing states to prepare, and i
l 18 enabling states to prepare, for such agreements and to i
l 19 maintain Agreement States Programs that are adequate to I 20 protect public health and safety and compatible with the 21 Commission program. Their reports also contained
- 22 recommendations to' expand the NRC training program."
4 23 I'll add that even if Illinois didn't do that 24 -- I mean, even if NRC didn't provide that, Illinois would 25 have no difficulty maintaining an adequate program. But NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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168 l
1 that's just for Illinois. l 2 Continued funding would send a message that 3 the NRC does_ recognize that the NRC and its licensees i 4 benefit from new states becoming Agreement States and the 5 overall cost of such regulation on a national. basis will 6 be lowered with additional Agreement States. So the 7 funding of annual training and travel is a small price.to !
8 pay and in fact more states becoming Agreement States will 9 save more than that cost. It is our firm belief. ,
1' 10 With regard to option one, the Federal 11 Government as a whole is looking for ways to save money.
12 And that certainly would not result in any cost savings to l 13- the Federal Government. You'd have a huge transition cost 14 and' training cost for EPA. ;
15- With regard to option two, while we support 16 the concept of all states-becoming Agreement States, we're 17 opposed to the proposal as it is described and presented 18 in option two. We're in favor of continuing programs 19 developed in partnership with the Agreement States as 20 presented in option three. And that is the Commission's 21 preliminary decision.
22 As a sign of its changed view, the Commission 23 should immediately modify its policies and seek Agreement 24 States' concurrence on all rules, practices and procedures 25 which will become part of the program to which Illinois NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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169 1
1 and other Agreement States will be expected to be ,
2 compatible. We recognize that NRC has an oversight role 3 that the Agreement States don't have. With regard to i
4 developing new regulations and policies and things, we 5 think we ought to be involved in the very front end in 6 coming up with those policies, not to have NRC develop 1
I 7 them and then say this is what it is, you have to be l 8 compatible.
l 9 We think NRC has misinterpreted the term 10 co-regulator as it's presented in option four. Illinois 1
11 does not support this option as it's presented. The term ,
I 12 co-regulator should represent a shared vision of the NRC 13 in the states. And that shared vision should have to do 14 with the fact that we have the same health and safety 15 goals.
16 With regard to option five, the NRC and the 17 states, through the Conference of Raised Control Program 18 Directors, should begin working on a long term goal of 19 implementing option five, where regulation of byproduct 20 material is vested with the states. So a long term goal 21 and plan should be that all states become Agreement States 22 essentially and NRC get out of most of that.
23 That's all I have.
I 24 MR. CAMERON: Okay, Steve. You gave us a lot 25 to think about there, and I hope that it sparks a lot of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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170 1 discussion. Let me ask you for -- let me try to restate 2 something that ;ou said and ask you if it's correct.
3 You were talking about all of the benefits l
! 4 that the NRC receives from Agreement States in the context l 5 of providing the travel, training, et cetera, et cetera, l
l 6 which we're not doing now, but we're struggling with that. ,
7 Is it also.true that some of those benefits really include 8 benefits to NRC's regulatory program as a whole? In other 9 words, to the regulatory program in NRC states and not 10 just to Agreement States. In other words, it's not just 11 a narrow quid pro quo, but that benefit that the Agreement 12 States gives back is spread through the entire NRC 13 program?
14 MR. COLLINS: Yes. Steve Collins. That was l l
15 my point exactly. Some of the. benefits are directly to -!
16 NRC. Some of the benefits are directly to NRC licensees, 17 whether they're located in Agreement States or in non- l 18 Agreement States. So it's not equally distributed, but 19 there certainly, with regard to the equity issue, we 20 believe that the NRC and its licensees receive back more l 21 value than the cost of NRC covering the expense of that 22 training.
23 MR. CAMERON: Great. Thank you. I wanted to l
24 clarify that because I think that's an important point l
l 25 when we talk about the equity issue. It may not be a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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171 1 determinative point, but it's an important point. And I 2 wondered if anybody from the licensee community would like 3 to say anything about the so-called equity issue at this i
4 point, which is the Commission's concern. Yes?
d 5 MS. SCHULTZ: Cheryl Culver Schultz, Radiation 6 Safety Officer at William Beaumont Hospital in Michigan, l
- i. 7 broad scope license. NRC fee payer, and'I strongly concur i
- 8 with your statement, Steve. I think we all get benefits '
i
} 9 from the Agreement States' contributions. And a lot of I i
10 what you stated is consistent with our hospital's goal, 11 which is to encourage the regulatory authority to be moved 12 from NRC over to the state. And although Michigan is not f 13 one of the ones on the plate to come, you know, up to the i.
j' 14 plate, basically, at this point,.it certainly is the .
i 15 hospital's goal that Michigan will do that. And we see
{
. 16 the role of the Agreement States currently as very 1
17 important in achieving that goal.
l l
18 And so, we don't mind paying the fee. And we 19 certainly feel we derive the benefit from the work that 20 you do, California, New York.
21 MR. CAMERONr Okay. Thank you very much, !
22 Cheryl. Could we have other licensee viewpoints on that, 23 because I think that's important to get this type of 24 feedback on this issue. And you heard one view from --
25 it's Cheryl, right? From Cheryl. And Mark?
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172 1 MR. DORUFF: Mark Doruff. I'm with Amersham
- f. 2 Corporation, a NRC fee-paying licensee, Agreement State 4 3 fee-paying license, and a non-Agreement State fee-paying 4 licensee. And also on behalf of counsel on radionuclear 5 and radiopharmaceuticals, whose members are also foreign j 6 to all three of the aforementioned categories.
}
, 7 We endorse a combination of options two and 8 three and some aspects of option four. We strongly urge 9 NRC not to consider options one.and five. The objectives 10 to be gained by continuing the Agreement States Program, 11 while. treating Agreement States as co-regulators, the NRC 12 should strive for compatibility between the NRC and 13 Agreement States as well as between the Agreement States 14 themselves to enable our industry to continue to conduct l
-15 interstate commerce. However, this compatibility should 16 not come at the expense of adequacy with regard to 17 essential radiation protection principles. l 18 A major consideration to which relatively 19 little attention was paid in the issues paper is a need 20 for cor.patibility between the Agreement States and the NRC 21 as well as between the states themselves. Another issue 22 that was not addressed at all is reciprocity. The issues ;
23 of NRC and Agreement State adequacy and compatibility have 24 been addressed in detail by the recently revised and 25 published NRC Agreement State Working Group Report and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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173
- 1 Policy Statement on Compatibility and Adequacy. And CORAR 2 and Amersham also agree, for the most part, with the 3 policy statement and with the approach taken by the 4 Working Group. And CORAR has provided comments on this 5- report and-the policy statement separately.
6 MR. CAMERON: Okay. Thank you, Mark. Do we 7 have other comments.out here? Yes, Kristin?
8 MS. ERICKSON: I'd like to say that I and our 9 institution and other RSO's of this type predominantly 10 agree with what's been said here today, but one thing that 11 really rankles for a direct NRC licensee like ourselves is 12 the fact that there's tremendous disparity from one 13 Agreement State to the next and in fact, from some of 14 those to the NRC standards. There are Agreement States I 15 know of that have standards that are so far, I would say, 16 beneath. Some licensees are permitted to do things that 17 if NRC wr. ' nswer the question, it would be a completely 18 different answer. And I think there needs to be a lot 19 more uniformity amongst these Agreement States.
20 Now, to say that some are beneath the 21 standard, there are also some that are far above it. And I
22 those do give us all some benefit. And we appreciate 23 that. We agree that there should be some kind of 24 recognition of their contributions, but we would like to 25 see those few, what I would say, might be substandard NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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174 1 Agreement States brought up to at least the minimum NRC 2 standards.
3 MR. CAMERON: Okay, Kristin. Let me ask you a 4 clarification on that. Is it, on the states that are 5 allegedly below the NRC standards, is it because of the 6 regulation itself or is it because of the way it's 7 enforced. In other words, implementation?
8 MS. ERICKSON: It's the implementation and the 9 inspection and oversight, both.
10 MR. CAMERON: Okay. Thank you. Comments on 11 that particular point from anybody?
12 DR. KNAPP: I'd like just to make one comment 13 on that. One of the fundamental tenets of the NRC's 14 program is that the Agreement States in fact achieve 15 adequacy and compatibility, not just to the regulations, 16 but the way in which they're implemented. I'm not looking 17 for any comments in this forum, but any licensees or 18 Agreement States or anyone who is aware of any Agreement 19 State that is substantially below the NRC standard, we 20 would very much like to hear about it. And we will deal 21 with it constructively, but we do need to deal with it.
22 So please, take an opportunity to share that with staff or 23 whoever in the NRC you think would be appropriate.
24 MR. CAMERON: Okay. And I just want to try to 25 put a finer point on some of the things we've been talking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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175 1 about. Clare, could you put up the Commission's l
2 preliminary views slide? The first one? Thank youe 3 If you look at the fourth star, the one of the ;
I 4 Commission's preliminary views is, provide training to the
)
5 Agreement States, but funding for travel and technical I
6 assistance would be borne by Agreement States. Now, to 7 just clarify one thing that Steve said earlier. Steve,
- 8 you referred to the Commission's policy of about a year i 9 ago. And is it correct that that policy is different than i
10 the fourth star there? In other words, travel and 11 technical assistance would be provided, or was provided?
12 MR. COLLINS: Steve Collins. Yes, up until 13 around October 1st, not only was the training provided, 14 but it wasn't on a space available basis. It was
- 15 basically all of the funding for the travel and the 16 tuition, if there was tuition, per diem and all of those ;
)
17 expenses for the training of Agreement States staff was i 18 paid'for by the NRC as they contracted for courses and 19 they paid for the whole course at one time and also paid 20 for the travel expenses for the state people to be there.
21 And there were a whole lot of benefits, as I stated 22 earlier, to the NRC and its licensees that they received 12 3 from the NRC paying for that.
j 24 MR. CAMERON: Okay. Great. So the fourth
- 25 bullet gives back some of what was suspended. And to go NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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176 1 to the Commission's, the slide where they particular seek i 2 comment on whether NRC should fund Agreement State 3 training, travel, technical assistance, I think we've 4 heard a good presentation from Steve on some of the things 5 the Agreement States give back. I think we heard from 1 l
6 Cheryl that at least from one licensee's point of view,-
7 that she agrees with that and they have no problem with 8 the NRC funding travel, training, et cetera, for the 9 Agreement States.
10 Kristin, I wasn't sure if that was the point i
11 you were trying to affirm or not. She's shaking her head l
l 12 affirmatively. Before we leave this issue, does anybody l l
13 want to chime in from Kansas, Ron?
14 MR. FRAASS: Ron Fraass, State of Kansas. As 15 Steve said, programs are seeming different. Our whole 16 program in Kansas is about 14 people and $800,000. Just 17 add some additional examples to what Steve said, that even 18 small Agreement States add, I think, considerable benefit i 19 to the NRC and the rest of the nation's citizens. I'll 20 give you a couple of our examples. j 21 Just our own staff time and training. In the 22 last year, we put about 250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> personnel time into 23 attending some of these courses. One of them was the 24 five-week course. That's one of the ones that the NRC 25 considers a requirement for our inspectors to really be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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177 1 able to do compatible work. In addition to that, about 2 two man months went into helping write some of these new 3 standardized regulations. That was one of our senior 4 staff who just retired. I put in personally eight weeks l 5 senior technica? staf f time in evaluating some courses 6 that NRC attends and then helping to train some of the NRC 7 staff. We got to do that in conjunction with the fermat j 8 courses. !
1 I
9 If you take those and put them at NRC's rate, l 10 which I understand is an unusual way of doing rates, of 11 $133 an hour, Kansas' expense was $100,000 plus. That's 12 10 percent, according to the paper, of their total 13 expenses if they reinstituted the full training and travel l
14 of $1 million that was shown in the paper.
15 The question of interaction between NRC and ,
.16 the states. It looks pretty clear to me. Article G on 17 274 says that the Commission is authorized and directed, I 18 emphasize directed, to cooperate with the states in the 19 formulation of standards, to ensure that state and 20 Commission programs will be coordinated and compatible.
21 That compatibility program is the one that we would have 22 to struggle with if'these training fees and such are not 23 reintroduced.
24 -I think we'll still be able to provide safety 25 for our citizens, but compatibility means, I need our NEAL R. GROSS .
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178 l 1 inspectors to go sit shoulder to shoulder with other state i
2 and'other NRC inspectors and hear the.same words.
3 Commissioner Betadikis, in her keynote speech 4 to the All Agreement States meeting, provided several fine 5 examples of that service by Agreement States, the NRC and 6 the nation's citizens. I want to continue the excellent l
l 7 work in relation with the NRC that began in 1964 with J
1 8 Kansas becoming the ninth Agreement State. I trust the ;
l ~
I 9 Commission will find a way to meet its own organizational I
- 10 goal to " meet our commitments, exceed expectations and do 1
1 11 what is right." We in Kansas will do our part to help the )
J l 12 Commission to protect all our nation's citizens from 13 excessive radiation. )
l 14 MR. CAMERON: Thank you very much. Any last i 15 comments before we -- Mal, did you want to say something l
16 before we go to Jim? ,
l i i
17 DR. KNAPP: Eventually I have a couple of ,
1 18 questions that have surfaced from what I heard. But go 19 ahead.
20 MR. CAMERON: Okay. Jim, would you speak, 21 please?
22 MR. WILLIAMS: Jim Williams from State of l l
23 Ohio. For a long long while, Ohio was not an Agreement l
24 State and has just entered into, has indicated its desire l
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179 1 our position as a host state for a low level waste 2 repository, which the state desires to license and 3 regulate.
- 4 As a state from the Atomic Energy Act.in 1954 5 forward, having over 1,200 byproduct material licensees, s
6 it was a significant chore to look at regulating and
- l 7 extending a bureaucratic setup to perform the Agreement
-8 State functions for all of that magnitude of a job.
9 Over the years, we've seen that number shrink 10 from its 1,200 peak to about 750 licensees in terms of
! 11 byproduct material that are licensed by the NRC.
12 Notwithstanding the fact that the 450 that have'gone down 13 have left us a legacy of sites that have to be remediated 4
14 and that are contaminated from the center of the City of s l
15 Cleveland to slag piles in eastern Ohio. j 16 There are a number of issues that now look 17 favorable to Ohio to become such an Agreement State.
18 However, when I look at the industry and Ohio just had a 19 seminar yesterday with an update on where we are in terms 20 of our efforts to meet the NRC's criteria for them to 21 agree under 274 that, yes, Ohio could become an Agreement 22 State, there's a tremendous amount of work that has to be 23 done and presently vested with the State Department of 24 Health, who will be submitting a written comment, Chip, to 25 this particular DSI.
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180 l l
l 1 However, the Commission's feeling in saying,
. l
~
2 explore providing seed money or grants to encourage states 3 to seek Agreement State status, it might be noted that in l 1
4 Ohio, users, the licensees, are paying dual fees now for a !
5 period of three years at about a 60 percent reduced rate.
4 6 However, it's a double fee process for a period of three 7 years to provide the state the ability to build up the 4
8 capability and the staff within the Health Department to. I 9 perform those functions of inspection and regulation that 10 the NRC would expect an Agreement State to do.
11 Whether or not this process can go in three or 12 four or five years as the time table expects, we're not 13 really sure. But the lack of-funding and the ability for 14 a large' state with multiple licensees that are almost a 15 legacy from the NRC would certainly speak for an 16 endorsement to have the NRC look at providing seed money 17 or some type of incentive to the state rather than having 18 the state have to appropriate that money or double fee the 19 licensees.
20 'MR. CAMERON: Okay. Thanks, Jim. That's a 21 valuable input from a state that's considering becoming an 22 Agreement State. A'nd I think you were talking about star 23 number two on the Commission's preliminary views,
'24 encourage more states to become Agreement States. But i 25 through non-monetary incentives. And what you're saying, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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181 1 I-take it, is that non-monetary incentives may not be 2 sufficient or there should be some type of monetary i
3- incentive. Is that -- could you just clarify that for us?
4 MR. WILLIAMS: In the Commission's preliminary i 5 views, star number three, explore providing seed money
- 6 and/or financial grants to encourage the states to seek' !
7 Agreement State status is what I was addressing and which, 8 you know, looks like a favorable position by the ;
-9 Commission to explore this. And it would certainly 10 relieve a burden on the licensees in Ohio who are 11 currently being double feed, and it would facilitate the 12 state's advancement-toward an Agreement State status in a !
i 13 more favorable time frame than three to five to six years. l t
14 MR. CAMERON: Okay. Thank you. I'm sorry >
15 about that. I guess that -- sorry for any confusion that ;
I 16 I might have added to that. But I guess when I look at 17 the second star, encourage more states to become through, 18 primarily through non-monetary. And then the third star i
i 19 is, explore providing seed money. I guess that this could j 20 be looked at to be in conflict, I guess, unless you 21 consider the fact that at least the Commission is saying, j
.22 well, we'll explore the seed money concept. And you're 23 supporting that.
24 And Mal, I don't know if you want to, in your 25 points that you're going to make, I don't know if you want NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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182 1- to add any clarification for us on that second and third 2 star. And then, we're going to go to Gordon Appel from i
i l 3 the State of Illinois after you're done.
4 DR. KNAPP: I'm not sure that I necessarily i
I
- 5 can provide more clarification, but I can ask for comment, 6 not necessarily here. Obviously, as you can see from the 7 bullets, the Commission is looking for ways to encourage 8 more states to become Agreement States. As you can see, 9 they'd like to do it through non-monetary incentives, 10 although they're considering seed money.
11 You mentioned a few minutes ago the difficulty 12 that Ohio has in building up this body of regulation.
13 When you make your final comments, if you have any 14 suggestions in addition to seed money, where NRC could !
15 help. For example, there may be some sort of an 16 assistance's role that we could take on working with you 17 either in Ohio, or Washington. There may be things we 18 could do that would make the job easier other than seed 19 money.
20 MR. APPEL: When we got this DSI, we looked at 21 that first option and said, well, they can't be serious.
22 And then we said, well, I mean, they sent this out for 23 review so they must be serious. So then we started to get 24 insulted. And then we realized we shouldn't get insulted 25 about things like this because they're asking us for our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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183 1 comments. And we decided that what that really meant is 2 that they were trying -- NRC was trying to tell Agreement 3 States, we want you all to send your agreements back. We i
4 want to regulate all radioactive materials in the United 5 States. And we realized that that probably wasn't the 6 case either. And we finally figured it out, or at least I 7 think I have.
8 And I think that was a message, you know, was 9 kind of an inside NRC thing. And it was a message to Dick 10 Banger, you know. Either get these guys under control or 11 you're going over to the EPA. I don't think, I mean, the 12 first option I don't think is a valid option for anybody.
13 And I hope you take my comments in the sense in which they 14 were offered. It just is not a productive option to 15 consider.
16 But secondly, I wanted to -- earlier in the l
17 day you talked about public understanding of radioactive 18 materials and things like that. And what NRC could do to 19 improve the nation's understanding at a more fundamental, 20 if not individual level, of radioactive materials and how 21 helpful that would be to us all. And I'd like to just 22 offer the suggestion that encouraging states to become 23 Agreement States and supporting Agreement States is 24 probably one of the most fundamentally constructive things 25 the NRC can do in terms of bringing a base of knowledge NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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184 1 regarding radioactive materials down to a level that is 2 accessible to the public in general. l 3 We answer a lot of. telephone calls on a daily 4 basis from people who are obviously poorly informed about ,
l 5 radioactive materials. We don't turn around and say, 6 well, you know, that doesn't deal with one of our
]
7 licensees so we recommend that you call the United State 1
8 Nuclear Regulatory Commission. Here's the telephone 1 4
9 number in Washington. We answer all those questions 10 straightforwardly, and we, I think, provide a service to l 11 everyone in the nation. We, collectively, as Agreement !
12 States, because I'm not suggesting that Illinois is the 13 only-one who serves this function. There are lots of -!
14 calls like that, and lots of issues that arise in state {
15 houses in' Agreement States never get brought'to the point 16 of an issue that warrants legislative or congressional 17 consideration, because there's someone in the governor's 18 office who knows that they can call the Agreement State 19 people over in the Radiation Protection Program and get an 20 answer about whether or not the current, whatever the 21 current hysteria is, whether it's medical or whether it's 22 transportation or whether it's materials in general,_they 23 can get an answer from people who are knowledgeable, and 24 the issue just kind of rests there then once the facts are 25 known.
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185
, 1 The third point I'd like to make about the 2 Agreement States option is that we could all argue day-in
[ 3 and day-out, both NRC and the Agreement States, about who 4- provides a greater service to whom. Being an Agreement 5 State, of course,'we believe that we provide the greater i
1 6 service. Okay? But all of us have examples of favors i
7 that we do for one another from time to time in an effort l l
8 to regulate radioactive materials in this country in some 9 sensible fashion.
10 The problem, and our particular problem, with j l
11 the way the training and travel costs initiative was taken l 12 by NRC, and we understand the rationale that is given, how l 13 NRC's licensees don't want to be paying for us deadbeats 14 in the Agreement 9tates to do our job. We understhnd 15 that. And we certainly would like to find another way.
16 But the point is that we could have gone to Congress, NRC 17 and the Agreement States, Illinois would have been happy 18 to participate in that, I mean, if the problem is that the 19 Omnibus Budget Reconciliation Act of whatever year it is 20 that's the excuse prohibits you all somehow from funding 21 Agreement States' training and travel, you could have come ;
22 to Agreement States and said, look, we would like your !
23 assistance in going to Congress and explaining to them why 24 it is necessary for them to perhaps fund some part of the 25 Agreement State program. That could have been done i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l 186 j 1 relatively easily. I'm not aware of any attempt on the i
2 part of NRC to develop an initiative like that with an )
3 Agreement States or more than one Agreement States. And l
4 now, you're going to find that, to a certain sense, we j 5 will end up in that position. This will end up being 1
6 ultimately resolved if, for some reason, the previous 7 policy on training and travel is not restored. I think i
I 8 ultimately we end up in Congress. Only in this case, the i
9 Agreement States won't necessarily be the allies that they )
10 could have been earlier on in this process.
11 MR. CAMERON: Thank you very much, Gordon. On 12 that last point,.that could still be an option, couldn't 13 it? If the Commission wanted to consider that. So I 14 think you -- okay. There is another option for us. And ,i 15 thank you for making that connection between public 16 education discussion that we had this morning and a closer 17 level of government on this. And I guess that I would say 18 that Dick Banger, when you read this transcript, we hope 19 you finally get the point. They_ haven't gotten it yet.
, 20 Do we have any further comments on this 21 particular issue?
i 22 DR. KNAPP: I still had a question or two, 23 actually.
24 MR. CAMERON: Okay. Good.
25 DR. KNAPP: Just areas where I'm not so much NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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i l' - -
..- -= - . - .- ._ _ .- .- - . - - - .. . -_ -
187 1 seeking comments this afternoon, but I'd like to hear the 2 comments eventually. With respect to funding, Agreement j 3 State training and travel to the training, I've heard at 4 least informally that one of the biggest sources of i 5- difficulty in the Agreement States may not be so much the 6 amount of money as the great difficulty that some 7 Agreement States have in getting travel outside their 8 state funded for any purpose. It's simply state law 9 regulation or policy makes that extremely difficult.
-10 I think if this is the situation, or the 11 extent that is the situation, the Commission would very i
12 much like to hear about that. A recognition that this is l 13 not simply an equity issue but it's an actual doability i l
14 issue for at least some of the Agreement States.
15 Another item I would be pleased to see 16 addressed. We really haven't.gotten to this afternoon, 17 but it underlies some of the Commission's thinking. There 18 is, of course, a close linkage between *ne Agreement 19 States issue paper and the Materials issue paper.
20 Specifically, if the Commission were to move strongly and 21 actively to get as many states as possible to become 22 Agreement States, t1 >
the Commission program would shrink 23 a lot. Now, what we would do at that point is an area 24 where we would be interested in your comment. I would 25 suspect that we are not likely to see a day in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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i 188 ;
1 foreseeable future when all states are Agreement States.
2 The comments we've gotten from some folks on the IOM 3 Report suggests that there are some states that vill not 4 become Agreement States, cannot, do not choose to do so, 5 and have various small programs.
6 In the event that virtually all of the states 7 are Agreement States yet there are a few left, then the 8 question becomes, what is an effective and a cost ,
9 effective way for NRC to deal with regulation of those.
10 Any suggestions we have, such as ways in which Agreement ]
11 States themselves might be able to assist in dealing with l 12 some of the non-Agreement States, if NRC were to go to a 13 minimal program, because we had a minimal amount of 14 licensees. Any suggestions like that would very much be 15 appreciated.
16 At the moment, because we are not seeing all I
17 states becoming Agreement States, it isn't an immediate 18 problem, but I know it's one that the Commission will 19 think about down the road. So we'd appreciate your 20 suggestions.
21 MR. CAMERON: Okay. Thank you very much, Mal.
22- And thank you, everyone. Let's take a break. Come back 1 23 at ten after three and we'll deal with the final paper.
24 (Whereupon a break was taken.)
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189 4
1 get started with our last presentation of the day and this 2 is the materials / medical oversight paper.
3 And we just remind you that tomorrow morning, 4 when we start at 8:14, there are a couple of papers that
. 5 deal with reactors. But there are two papers in that 6 session tomorrow that are directly relevant to materials 7 regulation and one is the Risk Informed Performance Base 8 paper that Tom Hiltz, who is with us today, is going to be 4
i 9 presenting.
10 And the second one that's a little bit further 11 removed, but still relevant, is the Power Reactor i
12 Decommissioning paper. There may be things there that are 13 relevant to material licensing, decomssioning.
14 So don't be discouraged just because it looks 15 like reactors. It we do have some material, materials 16 licensing relevancy there.
l l
17 And Mal, I guess I would just ask you to do 18 the last issues paper, 19 MR. KNAPP: The last issues paper. I feel 1
20 like Johnny Carson and Ed McMahon.
21 Unfortunately, the last would really be 22 tomorrow afternoon and that's when we will get the 23 applause for wrapping it up.
24 MR. CAMERON: Unless you'd like to applaud 25 nove .
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190 i
1 (Applause.)
l 2 MR. KNAPP: I will.take that in the. spirit !
3 that's intended, which is be brief so we can get to the i
4 discussion.
i l- 5 SPEAKER: No, get someplace else.
I 6 MR. KNAPP: Oh, somewhere'else, okay, fine. )
l l
7 Okay. The issue here is what should be the ]
l 8 future role and scope of our materials program and in !
9 particular, our regulation of the medical use of nuclear 10 materials.
11 And the, obviously, any strategic assessment i 12 has a question like this in it. But in particular, this l 13 one was raised because of the controversy over exactly to 14 what extent NRC should regulate nuclear materials and 15 medicine and another of key factors.
16 The first one, which we always want to l
17 remember, is that the materials which we now regulate are l
18 those created or made radioactive by exposure to the '
19 radiation during the fission process. That is to say, we 20 do not regulate NARM, we do not regulate x-ray, we do 21 regulate linear accelerators.
22 The seciond bullet: There are opposing 23 strongly held views of the regulated medical community and 24 Congress and the media concerning the regulation of 25 nuclear materials in medicine. There are and have been NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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191 1 people in medicine that believe that-we are far too 2 pervasive, far too prescriptive, that we interfere in the 3 practice of nuclear medicine.
4 There are those in the media and in Congress ]
l I
5 who believe that we are not effective in providing the
]
1 i
6 safety which is needed'.
7 As a result of these differing views, among f
, 8 other things, some time ago, we asked the National Academy 9 to take a look at our regulation of nuclear medicine and 10 make some recommendations as to what should happen. .
11 And they came back and in fact made the i 12 recommendations at least in part to Congress. That l
13 Congress should eliminate our medical use program. They ,
14 would have us out of the business, .they would have states i i
15 regulate nuclear materials and medicine and they would L i
16 provide, in their recommendation, through the Department '
17 of Health and Human Services, a sort of a leadership t
18 facilitator clearing house role on the part of the federal i 19 government, but not a formal regulatory role. ,
20 As we discussed in the last issue paper, a l
21 factor here is that as more states become agreement 1
22 states, we will have fewer materials licensees and l l
23 decisions that we make need to reflect those changes.
24 And finally, an ongoing process that we have 25 called business process reengineering, an effort to try to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 192 l 1 regulate more efficiently and effectively, is underway. -l I
2 Right now we are improving our licensing process. Once 3 we've gotten further along with that, we'll be looking at 4' our inspection process and others. ,
5 So these are the key factors that we think 6 would, should be considered by the Commission and by you. ;
7 With that in mind, the Steering Committee brought five ,
8 alternatives, five options to the Commission.
9 One is to increase our regulatory 10- responsibility. Take on the whole thing. Stick with what i 11 we have and then add to it NARM, x-ray, linear 32 accelerators.
.~. 3 The second option: Continue the ongoing 14 program, but again, as with the agreement state program, :
15 recognize that this is a program in change. We are doing 16 the business process reengineering effort and we are ,
17 examining our regulations to see how we can do better.
18 The third option: Decrease oversight of low 19 risk activities, but continue to emphasize high risk 20 activities. Now, I didn't say eliminate, I said decrease.
- 21 We might look at such things as diagnostic nuclear 22 medicine and perhaps no longer regulate it. We might do 23 this with'some gauges.
24 On the other hand, some gauges we might go 25 from specific to general license or as we looked at low-I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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193 1 risk activities, we might. find some that in fact were a 2 higher risk than their current regulatory status might i
3 suggest and so, while we would pay less emphasis to low 4 risk activities, we would do so with a careful check of 5 exactly where the risk lies.
6 If we continue to emphasize high risk 7 activities, these would be such things as fuel cycle 8 facilities and large scale radiators.
i 9 The fourth option: Follow the recommendations j l
10 af the National Academy of Science. We would discontinue 11 our regulation of medical activities, with the exception 1 12 of our oversight of device and pharmaceutical j 13 manufacturers. i 14 Last: Discontinue the materials program.
15 This is very much like the option that you saw as the last 16 option in the agreement states issue paper. And it would 17 follow a similar logic. That the states have the ability 18 to do this kind of regulation and that it lies within the 1
19 responsibilities the, the constitution generally provides 20 to them.
21 As with the option, or with the other issue 22 papers, these are broad options and they are in at least 23 some cases provocative.
24 Given these options, the Commission expressed 25 the preliminary view that they would like to continue with NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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194 1 the ongoing program, including the improvements the staff 2 is now making. They would like to move in the direction 3 of decreasing oversight of low risk activities and 4 continue to emphasize high risk activities.
5 In making these decisions, they would use a l 6 risk informed to perform its based approach, to help 2
7 decide which activities they would most like to emphasize 8 and deemphasize.
1 9 Perhaps more than in any other issue paper, 'l i
10 the Commission seeks comment from the public. We very 11 much like to have the view of the affected organizations, 12 particularly agreement states, CRCPD, and how we might !
l 13 best apply a risk. informed performance based approach. l 14 To elaborate that, on that briefly, a risk 15 informed performance based might be a very good way to go !
16 in the case of perhaps fu ' cycle facilities or broad
~;
17 scope licensees.
l 18 On the other hand, prescriptive regulation 19 could very well be appropriate for licensees whose work is 20 relatively simple and who may have limited means to 21 comply, such as radiographers or perhaps some gauge users.
22 They might, they and we might be most comfortable with 23 prescriptive regulation.
24 So we'd be looking for comments as, if we move 25 towards risk informed performance based, where we might j
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195 a
1 most effectively do it across the spectrum of materials 2 licensees.
3 On thought that-was raised was without trying 4 to get all states to become agreement states, perhaps we 5 should strive to get states to become what amount to I
6 agreement states for medical use only. Interested in your i
7 comments on that idea.
8 Another question: Do you believe that a l 9 single agency should regulate radiation safety. Perhaps
- 10 single federal agency might be a way to look at that 11 question. Recognizing that now there is broad regulatory 12 responsibility among a variety of agencies, including NRC, 13 EPA, DHHS, DOT. Would it be better to have a single 14 agency regulate safety.
15 And you could consider this question in two .
l 16 ways. You might have a single agency regulate safety, but t l 17 perhaps not set standards. Or you might have a single i
18 agency do it all. For example, right now, EPA has the 19 authority, responsibility, for setting generally 20 applicable environmental standards. Perhaps all these 21 responsibilities should be vested in a single agency.
22 Finally, we do have report in hand from the 23 National Academy of Science Institute of Medicine. We put 24 the information we have in terms of the conclusions that i
4 25 they reached in that report. Some concerns the NRC staff L NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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% 196 1 has and the public comments that we had through about the 2 end of August into an attachment to this paper.
3 We'd be very interested in your views as to 4 whether that attachment reflects an accurate picture and 5 in any case, whether you agree with the conclusions that 6 were reached by the National Academy of Science.
7 That's the paper and the Commission's 8 preliminary views and now.with Chip's help, we'd like 9 your's.
10 MR. CAMERON: Okay, thanks, Mal. .Perhaps the 11 best way to start this discussion and we can start it any 12 way that you all want to. But how about the, the first 13 star up there, applying a risk informed performance based 14 approach to NRC's oversight of medical activities.
15 And keep in mind this doesn't have to be, your 16 comments don't have to be exclusive to medical, but can be 17 on materials regulation generally.
18 Who would like to start us off on 19 this particular,.particular issue?
20 Kathy? Okay.
21 F3. ALLEN: Kathy-Allen from the Illinois 22 Department of Nuclear Safety.
23 It's very difficult to argue with motherhood 24 and apple pie up there. Yes, it sounds great to use a 25 risk based approach for regulating radioactive materials.
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197 l 1 Illinois strongly believes that you should not
- 2 isolate out medical, that you need to approach this all d
3 across the board.
l t 4 We're a little bit concerned that there is a 5 pendulum affect-that there are areas where the regulations 6 are too stringent and too onerous. Maybe we've gone a 7 little too far, regulating every nanicury and every, every 8 atom out there.
9 But we don't want to see a knee-jerk reaction i
10 that brings the pendulum back and creates a bigger problem 11 that five years, ten years down the road, we have a lot i
12 more work to do to get things back under, under some 13 reasonable control.
14 The public is currently protected because ,
15 there seem to be fairly reasonable regulations out there I
16 and radioactive material licensees generally try their i L
- e 17 best to comply with the regulations. We strongly agree 1
a 18 with the ideas of eliminating duplicative or, especially j 19 contradictory regulations, creating some sort of uniform i i 20 approach to regulations, updating the regulatory 21 guidances, documents out there, BPR, the business process i
22 range nearing ideas and the information being presented 4 23 through that group, about streamlining licensing 24 processes.
25 We think these are fantastic ideas and this is NEAL R. GROSS -
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198 1 a good way to streamline the process and try and reduce l
l 2 cost associated with, with regulating materials licensees.
3 And also from the licensee standpoint, 4 streamlining the process to get a license and maintain a 5 good program. Gee, you know, where do you begin?
6 Is this, okay.
7 MR. CAMERON: Do you want to take a break?
8 MS. ALLEN: Yes. Does anybody else?
9 MR. CAMERON: I guess that if it's going to 10 be, one of your points is that risk informed performance 11 based approach is great, but it may be difficult to say 12 any more about that until you know exactly what that, what 13 that means. And I think Tom is going to be helping us 14 with, with that concept tomorrow.
15 Do you want to say anything more about that?
16 MS. ALLEN: Sure. Sorry.
17 MR. CAMERON: This is, this is Tom Hiltz over 18 here, for people who don't know him. From Nuclear Reactor 19 Regulation Rights and he's going to presenting that, that 20 paper.
21 MS. ALLEN: There's another aspect to the, 22 this DSI. It talks about, when you're talking about risk 23 based regulations and trying to cut back the regulations 24 for some types of uses and gauges were mentioned in some 25 discussions.
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199 3
1 We want the Commission to look at option 3 2 very closely. A joint NRC/ agreement state working group 3 on devices recently made, reported that some of the 4 problems associated with NRC's general license program had 5 a lot to do with lack of oversight, inadequate control, i 6 poor accountability of devices and improper disposal of
..' 7 those devices.
8 A lot of that had to do~with lack of oversight 9 by the individuals using the devices, lack of oversight 10 from the regulatory agencies and it recommends increased 11 oversight of these devices, especially for certain 12 categories of devices. Or possibly making a determination '
13 that there is a very low risk, move them to possibly an 14 exempt-type status, i 15 So we caution you to categorically say, well, l
16 there's other categories of users out there that we need '
17 to just drop the regulations off of and, and just treat 18 them as general licensees. You need to take a look at the 19 whole approach and role in some of the ideas from the l 20 working group concerning problems that have occurred when 21 programs have been left alone and there's inadequate 22 oversight.
23 MR. KNAPP: I think your point is very well 24 taken. The Office Director, Carl Paparillo, and I share 25 your concern about whether the current general licensee NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 program in fact fulfills what the NRC would like it to 2 fulfill.
3 And we are pleased to have the working group 4 results and your point is well taken.
5 MR. CAMERON: Okay. And let's continue on l 6 with this discussion. Keep in mind that we're not only J
t 7 talking about this first bullet where the Commission is 8 asking for views of risk informed performance based I
9 approach, but if you go over to our options, the third 10 option is decrease oversight of low risk activities with i
) 11 continued emphasis on, of high risk activities. And at L 12 least I read those, the option and the first question, as 13 being a link together, even though they're not exactly i 14 stated that way.
1 15 Do we, Steve?
16 MR. COLLINS: Steve Collins with the Illinois 17 Department of Nuclear Safety representing the Organization i 18 of Agreement States.
l 19 The Organization of Agreement States and the
- 20 CRCPD both have already submitted comments that were
! 21 virtually identical that Kathy Allen just presented, just 22 so you're aware.
' j 23 With regard to the decreasing of oversight on j 24 low risk activities and continued emphasis on high risk 1
25 activities, some of the reasons that some of the low risk j NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.
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201 1 activities are just that is because of some regulatory 2 overeight. And Kathy has cautioned with regard to don't 3 let the knee-jerk reaction go too far the other way is, is
. 4 very carefully evaluate with your partners, the agreement-5 states, in how you're going to deregulate any of these j- 6 areas so that in fact we, we keep.a few of the functions
.4 7 that are really needed, to keep them low risk.
] 8 So it's something that, the GL program and the 9 working groups report, we think accurately, pointed out 10 one area where you have a very low risk type of use of 1
11 radioactive material that stays low risk until that safe ,
12 or low risk source gets out of control and gets melted 13 down at a scrap metal dealer. And all of a sudden i 14 something very low risk becomes something that's not low
- 15 risk.
16 And due to the fact that it has been low risk 17 for so long, NRC in particular, and some agreement states, 18 have not tracked those devices well. And now the steel 19 industry is paying for it and they're coming back and 20 saying, this isn't right. You shouldn't be making us pay 21 this cost.
22 And so the working group's recommendetion that 23 there is a need for some increased oversight, and 24 particularly tracking by the regulatory agencies, needs to 25 be brought home and this is one particular area where
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202 1 there can be'a lot of decrease in our regulatory activity.
2 But that's going to have to be matched by an increase in 3 certain other parts of it.
4 That increase can end up being a less time ,
1
- o 5 consuming and less costly thing after an initial year or i
1 6 two of'getting the database in good shape. ;
I 7 MR. KNAPP: I think that's what we mean, or at i 4
1 8 least I hope that's what we mean by, when we say risk l 9 informed. We'd be looking not just say at the risk of 10 gauges, but at where the risk of gauges occurs and then l
11 doing a performance based program so that we, we tackle i i
1 12 the areas of risk. i i
13 Again, I think it's a good point and certainly ,
l' 14 would be our hope to consider these issues just that way.
15 MR. PANGBURN: George Pangburn, NRC.
'16 When we were working on this particular paper-17 and some others, we, and this maybe obvious to some of 18 you, but Steve, Steve's comments and Kathy's are well l i
13 taken because we recognized that if we made decisions, any J
20 decisions that we make regarding low risk have to be done 21 very carefully. Because if we make. decisions and remove 22 controls from classes of devices or licensed activities, ,
23 we have done just that. We have removed controls and we 24 have to make sure:that we're very comfortabl'e with that.
25 Because the consequences may not be ones that, that we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. 1 (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 33
203 1
1 intended. 3 2 MR. CAMERON: Well, I was going to ask about i
3 the, I was going to move to the next star under the
$ 4 decrease oversight-of low risk activities and see if
, 5 anybody wanted to perhaps explore the relationship between 6 those two stars or to just comment on the fourth star, 1
7 period.
- 8 Yeah, Cheryl.
9 MS. SCHULTZ: Yeah.
10 MR. CAMERON: Wait until I give you the i i 11 microphone here.
12 MS. SCHULTZ: I'd like to go ahead and comment i 13 again, as the RSO at Beaumont Hospital, which is the 6th i 1
i 14 largest hospital in the country right now.
h 15 And these comments represent the viewpoint of l 1
l 16 our hospital's administration, members of our radiation 17 safety committee, our nursing staff, and the majority of 18 our radiation workers.
19 And we support the IOM report and we also 1
~20 support the ACMUI recommendations that go ahead and 21 address regulating all of radiation in medicine in a 22 uniform fashion.
23 We believe this is in the best interests of 24 our patients and we are very much interested in moving the 25 whole process in that direction.
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304 4 1 With that in mind, I'd like to address option 2' 4, which is the' option I'm here to say that we support.
4
- 3 And that is to go ahead and discontinue NRC's regulatory l l
4 authority over all medical use of byproduct material, to
! 5 give the regulatory authority to the states,' and to name i
- ~
6 another federal agency'to provide a leadership. role, as I
7 opposed to a' regulatory role. '
8 We also support that that federal agency be an 1
9 authority on healthcare.
- l
- 10 And on presenting this, I want you to know 1
'l 11 that we're also very aware of the impacts that were stated 12 in the DSI, number 7 paper, related to unfunded federal 13' mandates, the fact that the DHHS doesn't want to do it. ,
l
\
14 And that we need to have same consistency of basic 15 regulations.
16 So we see the problem with option 4 and yet we
'17 feel strongly that we need to stand up and say we are in i
18 favor of option 4. j
.19 Now, if you don't mind, I just want to finish 20 saying the rest of my statement at'this point. Which is, l i
21 realistically speaking, if option 4 were not to come i
22 about,.we would like to see, at a minimum, that the NRC. l 23 would consider rescinding this fundamental 10th tenant 24 that was incitded in the medical program policy statement
[ 25 of 1979, which states that the NRC has a commitment to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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205 1 protect the patient from the use of radiation in medicine.
2 We feel this commitment is in conflict with 3 the goal of the use of byproduct material by physicians in 4 both nuclear medicine and radiation oncology where they're 5 using the radiation to diagnose, treat, and cure our 6 patients.
7 It is our belief that this commitment and this 8 policy statement has led to regulations that are costly to 9 comply with, burdensome, overly prescriptive, and 10 intrusive into the practice of medicine.
11 We strongly believe that patients should not
- 12 be regulated as members of the public and they should not 1
i 13 be considered essentially as part of the regulatory group, 14 if you will.
15 So that's, that's my take on option number 4
- 16 right now. I could go on and say the rest, but maybe I'll
- 17 wait till later. Let somebody else say something.
18 MR. CAMERON: Thanks, Cheryl. And we will j 19 give you a chance to say the rest.
t 20 MR. KNAPP: I just, I would have two 21 questions. You don't need to answer now, but in your 22 final written comme'nts. I think the Commission would be 23 interested.
24 In view of the fact that DHHS does not appear 25 to want the role, any commencs you have on, for example, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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206 l 1 well, they may not want it, but let's have them do it. Or l
l i 2 if you have an alternative agency you would like in that 3 role.
4 Second, your views are rather strongly opposed l
5 by a couple of non-agreement states who do not want the 6 responsibility. Any suggestions you have as to what would
! 7 be a good way to deal with those concerns would be very 8 much appreciated.
9 MR. CAMERON: And I guess I would have one 10 question for you, Cheryl. That if you could try to answer 11 now, it might -- t 12 MR. KNAPP: You may need to give her_30 13 seconds-on, we'll overwhelm her with questions.
14 MR. CAMERON: Okay.
15 MS. SCHULTZ: -- the second one --
1 16 MR. CAMERON: The second question is? l i
17 MR. KNAPP: The second question, one of the l i
18 concerns that I have in looking at the overall issue of l 19 following the IOM recommendations, is that among the 20 public comments we've received, there are one or two 21 states who have been adamantly opposed on the view that 22 they do not have, whether it's the money, the will, the 23 competence, to take on that responsibility.
24 One of the things that I think the Commission i
i 25 will find very important is this concern about having a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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- 207 l
- 1 few states or a few segments essentially unprotected.
i 2 Now,'I wouldn't suggest that they would be unprotected, e
, 3 but-because of this concern, any views that you have that ;
4 would. alleviate that concern and yet still implement i
5 optio:t ' 4 would be a help.
6 MR. CAMERON: I think she's going to try to l
?
3 7 give-you some answers to the second question now.
8 MS. SCHULTZ: I think I'm in one of those 9 states. Michigan,-for example, does not have the.will to 4
- 10 become an agreement state.
t i
11 But I believe that Michigan has the will to go 4
12 ahead and regulate all medical use of radioactive 3
F 13 material. Because they already have regulations in place l 14 and.I think the problem with Michigan's reluctance is ;
i 15 related to the fact, much of what the man from Ohio was 16- describing, which is this process that the state has to go 4
3 17 through to become an agreement state.
I, 18 I think if you were going to consider the i
19 recommendation of the IOM, which is transferring that 3
20 authority to the states and then allowing the states 21 themselves to go ahead and come up with their own plan.of l-1 l 22 regulating. And one of the incentives that was presented 3
23 in that report was tieing this together with re abursement j 24 for services.
4
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'208 l
1 up the moniker of regulating all of radiation in medicine 2 in Michigan, Without the process of going through the 3 agreement state.
4 MR. CAMERON: Okay. And let me ask you one l 5 last question.and then we'll give you a break.
I 6 To try to get to the underlying rationale 7 behind recommending'the discontinue regulation star.
8 If the NRC in concert with the states perhaps i
9 undertook an' activity to perhaps not rescind the 10 commitment in the policy statement that you talked about, 11 okay? But if they, if they undertook a look at the 12- medical regulation area from the low risk standpoint and 13 maybe that would sweep in the, the commitment.
14 If, if something was-done in that area, would 15 you still support. star number 4 as your primary option?
16 MS. SCHULTZ: Very cleverly worded. And 17 actually that is our fall-back position.
18 Absolutely. We would very much support, as l,
19 opposed to option 4, the notion of a combination of option 20 2 and 3 under the following conditions.
21 That would be that the NRC rescinds the ;
22 medical program pol' icy statement of 1979, rescinds parts 23 of 10CFR, part 35, specifically the quality management 24 program and the definitions related to the word f
l 25 misadministration. And also,. training qualifications for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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+
p ~ g m+,
- --y y w q .--.-r .
209 1 the physicians.
2 MR. CAMERON: Okay, good. Thank you, Cheryl.
3 How about some other, other people on this i
4 issue? Mark?
5 MR. DORUFF: Mark Doruff with Amersham 6 Corporation and counsel on radio -- and radio l
7 pharmaceuticals. j 8 While we support the concept of decreasing j l
9 regulatory oversight for low risk activities, as outlined l 10 in option 3, we also recognize the need,.the needs of our j 11 customers in diagnostic and therapeutic medicine to get 12 some relief from the, from the regulatory oversight of NRC 13 and medical use.
14 However, we believe that the approach ;,Pmoosed 15 in option 4 is, is a bit extreme and for a number 4 -
16 reasons, we don't necessarily, or we really don't support 17 that the NRC regulation of medical use be totally !
18 deregulated.
19 We believe that that would result in a number l 20 of logistical, significant logistical problems for the l 21 manufacturers and distributors of these products. And I, 22 I think what we would like to recommend at this time is an 23 enhanced participatory rule-making be initiated to resolve 24 the issue of regulation of medical use and involve all the !
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1 210 1 1 reach a reasonable, logical consensus on the issue. :
2 MR. CAMERON: Okay. Thank you, Mark. We'll 3 go to Kathy Allen.
4 MS. ALLEN: Kathy Allen from Illinois.
l L 5 In addition to Mark's comments about the -
l 6- enhanced participatory rule-making, we would also like to 7 see some sort of white paper or some sort of document 8 describing the jurisdictional boundaries for NRC-and FDA 9 and-what each entity is responsible for regulating and 10 especially concerning where the practice of medicine.
1 11 falls. ;
12 When you look at a medical device, there are )
l 13 certain areas that NRC evaluates and FDA evaluates and 14 it's not really clear, or that that there's a gray area 15 between NRC and FDA as to who's looking out for what 16 areas. And I think if it was very clear as to what FDA's 17' role was and NRC's role and the jurisdictional boundaries 18 regarding medical use of materials, I think that would be 19 very helpful.
20 MR. CAMERON: Thank you, Kathy. Mal, do.you 21 have anything to say'on that?
22 MR. KNAPP: I note that's a good point. I 23 believe'that our relationship, obviously NRC has l
l 24 relationships with a variety of agencies, including FDA.
25 Some are a little rockier than others.
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- 211 !
- 1 I think right now we've got a pretty good i 2 relationship with FDA and I'm trying to recall whether we 3 have an MOU in place. Claire tells me yes, we do have an !
4 MOU in place, i 5 I think that it would be worthwhile to make l
) 6 sure that if that's not available as publicly as it should 7 be, it will. I'd like to think that information is there l
4 8 and we'll try to provide it. l I
9 MR. CAMERON: Okay. We're going to go over
)
10 here.
1 1
11 MR. RONNIGEN: I'm Reg Ronnigen from Michigan i l
12 State University, but I'm with the National Super --
13 Encycletron facility there.
14 I wanted to make a comment about accelerators.
15 This is a, if the NRC goes in some of these directions, 1 16 this will be quite an endeavor because, well, first of 17 all, it impacts, if you regulate accelerators, there are 18 DOE accelerators and we have a big one in this area here 19 with Fermilab that would come under this particular topic.
20 And which I think in part that would be a good 21 thing. Have that outside oversight say of a DOE facility.
22 I'm kind of in favor of that.
23 For one thing, is, this would give us a common 24 language in which to talk. Like our laboratory is quite a 25 bit smaller than that, but laboratories have to constantly NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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312 1 evolve over time to exist and we're always in a constant' I 2 state of construction, it seems. And we rely on external l 3 organizations and people from Fermilab in particular to 4 provide us with some insight and expertise and how we H 5 should go on in the future. And it would be really nice 6 if we could-all talk the same language in talking over the !
7 issues and how to develop a safe program as we progress.
8 Also, I want to point out that accelerators in 9 medicine is a whole different, that's a whole different 10 ball game. There's more and more accelerators being used 11 in medicine as, say direct therapy machines. And they 12 carry with them all of the problems of that other research 13 accelerators have. Doses to_ personnel, potential for 14 contamination, activated parts either being, or neutron 15 activated parts, and waste. 'And eventually 16 decommissioning.
17 So there are a lot of issues that are 18 involved. Especially one has to think about that and I 19 think I agree-with some of these comments, one has to 20 carefully draw the line where medical stops and other. ,
l I
21 things should be taking over.
l 22 MR. CAMERON: Thank you,. Reg. Mal, do you l i
23' have any comment on that?
24 MR. KNAPP: Only that I appreciate the comment R2 5 ' very much.
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. _ _ _ ._ _ __ ._m . =.
213 1 1 The, you know, we have had a number of 2 comments in the past that we should expand into the area 3 of NARM. The possibility of looking at accelerators is 4 one that I'm happy to get any public comments on because I
, i j
5 have no idea where we'll head, but we'd like to get a i
6 sense of the public's view of accelerators. Or for that
) 7 matter, x-ray machines.
8 So thank you.
9 MR. CAMERON: Reg, are you, who are you l l
10 regulated by now? 1 11 MR. RONNIGEN: Well, it's the State of
- I 12 Michigan. But they are rewriting their particle i l
13 accelerator regulations currently. j 14 So, it's, it's an evolution process. We're,
, 15 they're good, but right now they're based more on like 16 turn-key accelerators. And for a large laboratory, it's a i
17 little bit more difficult to, how to really implement 18 those regulations in terms of current state, state-of-the-19 art accelerators.
20 And then for, of course, the, for byproduct 21 material sources and things like that, CNRC. And Kristin 22 provides our oversight directly.
23 MR. CAMERON: Okay. Thank you. We're going 24 to go to Kristin and I guess everybody, Reg just sort of
-25 moved us up to looking at the, the first option there.
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214 l 1
1 And we'd like to get some viewpoints on that. Kristia?
2 MS. ERICKSON: I'd like to add some continued i
3 comment on accelerator-produced regulation. I 4 As the radiation safety officer for the broad 5 license and' our large accelerator, which runs around the 6 clock. 200 employees, 365 days a. year. And we have some 7 actual real radiation risk there, f
8 As an RSO, it was a tremendous difficult 1
9 challenge coming on-line and trying to implement a program 10 because they kind of fell through the cracks. Although l 11 the State was the regulator, they don't really have the 12 staff, or in some cases the expertise, to regulate this i
13 big, huge machine. ;
14 And in order to do it, what I basically did 15 was I chose and convinced Reg and their, their uppers, to l 16 go along with thin, is that we chose to use NRC law for l
17 the whole place because it was the most uniform, because l
18 those requirements and the way that they were written were l'
l 19 able to be developed and modified and, and you know, in I
i 20 some cases fine tune to work for even that facility with 21 all the varied things that go on there.
22 So even though most of it.is not NRC 23 regulated, we elected to do that and it's working very 24 well.
25 So, I, my comment would be that I think we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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215
.1 should have the NRC overseeing accelerator-produced 2 radioactive materials.
3 One other little fine thing that falls through 4 the cracks, which was a funny little chuckle between i
5 region 3 and ourselves, is the f.sotope P33 is now common !
)
6 molecular biology isotope _and at the time _ fell through the i
7 cracks because it was accelerator produced. And we again 8 elected to use NRC requirements. Because you'd have one 9 set of things for one isotope in the lab and all the 10 others were another.
11 MR.' CAMERON: Well, thank you. It seems there 12 is.some support here for, for option 1. And let's keep, l
13 Mark, do you want to comment,_ comment on that or comment 5 1
14 on something else?
15 MR. DORUFF: Mark Doruff, Amersham and CORAR.
16 I would like to comment on the issue of NARM 17 and regulation of NARM materials by NRC.
18 We'believe that one federal agency should' 19 regulate both NARM and byproduct material and we believe 20 this agency should be the NRC.
21 Amersham currently has five operating 22 commercially producing cyclotrons in the U.S. -Two, two of 23 these-are located in a, in a non-agreement state, New !
24 Jersey, three are located in Illinois. And again, we 25 believe that NARM should fall under the purview of a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.
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216 1 single federal agency, being the NRC 2 And we also would be in favor of a single 3 standard-setting agency, an independent advisory group, 4 to, to recommend standards of radiation protection and 5 regulation for both NARM and byproduct material.
6 MR. CAMERON: Okay. Thanks, Mark, 7 Kathy, did you want to, George, do you have a 8 clarification you want to put in on that first?
9 MR. PANGBURN: Mark,.I was wondering, did you 10 mean the same agency should be standard setting, or you 11 wanted a separate agency that would be standard setting? ,
12 MR. CAMERON: Do you want to answer that for 13 the record?
14 MR. DORUFF: A separate standard-setting 15 agency, apart from NRC. -
16 MR. CAMERON: I'm glad you gave the same 17 answer. That's fine.
18 Kathy?
19' MS. ALLEN: Kathy Allen from the Illinois !
1 20 Department of Nuclear Safety. l 21 We have, we have gone on record as, as also 22 supporting NRC's idea, sorry, we agree with the idea of 23 NRC expanding its regulatory authority under the AEA to 24 cover all forms of ionizing radiation.
25 We recognize that this a major undertaking and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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217 1 the DSI in fact mentions that it would take several 2 hundred FTE's to regulate NARM. We take issue with that 3 estimate of number of FTE's. I think if you ask the 4 agreement states if we have used that many FTE's to 5 regulate NARM and I think we can tell you,.it doesn't take 6 that many. j
- 7. You have I125 and I123, they're fairly 8 similar, it doesn't take much more-effort to regulate the 9 accelerator-produced I123 than it does the I125.
i 10 I think this also ties in with some of the 11 other DSI's you have. There was the discussion about 1
12 regulating DOE and other people have eluded to it also. I )
13 think if NRC were to actively look at the possibility of )
i 14 regulating, possibly beginning with discreet NARM, that l 15 puts you in a position so that if you are mandated to have j 16 oversight of DOE facilities, that's that much less effort 17 you have to put in at'that end. You'll, you'll be in a 18 position to accept more responsibility for the other DOE 19 activities. !
i 20 I do have to put in a plug for agreement 21 states, we do have areas of expertise. Almost all the 22 other agreement states also regulate NARM and we have 23 always been willing to offer our help in developing these 24 types of regulations.
25 MR. CAMERON: Steve.
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218 1 MR. COLLINS: Steve Collins with the Illinois 2 Department of Nuclear Safety, also.
3 With regard to that one single federal agency 4 having oversight over all forms of ionizing radiation, )
5 that does come with a qualifier that the NRC needs to 6- recognize that the agreement states already have f l
7 comprehensive radiation programs that cover all of those j l
8 things and in the event that one single federal agency, 9 the NRC or any other, in fact does achieve that 10 responsibility, don't mess our programs up. We're_in good 11 shape, don't tinker with it. .
I 12 Your authority would not interfere with what's j 13 already there in the states, but it would basically l 14 provide that same coverage for all federal facilities and 15 in non-agreement states where that program does not 16 necessarily exist.
17 MR. KNAPP: Thank you for the comment. I had 18 two things I wanted to mention.
19 With respect to the concern about several 20 hundred full-time equivalent FTE, you caught what should 21 have been an editorial mistake in the paper. It was our 22_ intent.to include the potential for x-ray and linear 23 accelerators and somewhere along the line in the editorial 24 process, those words got eliminated and it just dropped 25 down to NARM.
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219 I
1 So, that, we would agree with you. Based on l 4 2 the text of the paper as written, your comment is entirely j
3 correct and I'm sorry about the error.
I 4 I have a, I have one question for Mark and it 5 may not be convenient for you to answer it here.
- 6 You would recommend that there be two separate
- / agencies. One, I believe to set the standards and one to 4
] 8 implement. Are you in a position to expand on the 9 rationale for why that would be superior to have one
- 10 agency do both?
i
$ 11 MR. DORUFF: Well, it's our understanding that 12 NRC cannot establish standards. I mean, it's generally
! 13 the role of the scientific organization, such as NCRP and 14 ICRP to recommend standards. However, their position is i
15 they can do, they really cannot take the role of, of 16 moving those standards toward regulation. There seems to 17 be a gap between the role of setting the standards and the 18 role of regulating the licensees and the uses of 19 radioactive materials in accordance with the 20 recommendations of the scientific groups.
21 So, I don't know if that answers your 22 question, but we, we believe there needs to be separation i
23 between the agency that is enforcing regulations and the 24 agency that is establishing standards for the regulatory 25 agencies.
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220 1 MR. KNAPP: Let me pursue it just a bit.
2 Right now, for example, in some areas, we have 3 a relationship with EPA. Where by law they set generally 4 applicable environmental standards which the NRC then 5 implements. .And it sounds like you're endorsing that kind .i 6 of an approach. ;
7 In other words, NRC would not be in a position 3 8 to set standards. Another agency such as EPA or DHHS 9 would set the standards and NRC would only implement. l 10 I want to make sure.that I clearly understand .
I 11 and that the record clearly shows, I see by your nod that l l
l 12 is what you would intend. l l
13 MR. DORUFF: Yes. That is our intent; 14 however, we do not intend at all to recommend that EPA be 15 involved in this process. Either in a regulatory-capacity 16 or in an advisory capacity. I'm glad I had the .
1 17 opportunity to put that on record.
18 MR. CAMERON: Let me put one more nail on 19 this. j 20 You're going on the assumption that the,NRC 21 could not-set the standards. If the NRC could set the 22 standards, then would you support the NRC as a single l 23 agency to set the standards and implement? ~l 24 I don't know whether your recommendation is 25 based on what you perceive as a lack of legal authority on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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221 1 the agents, on the NRC's part.
2 MR. DORUFF: I think you also have to consider 3 the fact that the NRC would, is not the only regulatory 4 agency in the States and that with the agreement states, I 5 would assume that there would be a need to be an 6 independent advisory authority, in addition to these 7 regulatory agencies.
8 MR. CAMERON: Okay. So it's a larger issue.
9 Steve?
10 MR. COLLINS: Steve Collins for the 11 Organization of Agreement States addressing that same 12 question now.
13 What's been recommended and is being worked on 14 by working groups of the concentration of controlled 15 program directors, is that an independent body, through 16 the conference of radiation controlled program directors, 17 be established that would have as its, almost its sole 18 role, developing model regulations, with the involvement 19 of all the stakeholders and all that sort of thing.
20 So that all of the regulatory bodies that have 21 to establish standards in fact work together with the 22 stakeholders in developing a model rule that is basically 23 agreed upon and then each state and the federal agencies 24 that are appropriate, takes that model rule back and they 25 all start with the same process to go through their rule-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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222 1 making process.
2 So it is in fact, I'm not sure independent is 3 the right word, but it is a separate body that has as its 4 task for this shared working relationship and shared I
5 expense of developing the model regs and the policies and 6 the guidance documents that all go along with that, as 7 well as for the regulate.y justification that's required.
8 And then since each state in the NRC right now 9 has to go through its own rule-making process, it would do 10 that as a separate part.
11 So that is some separate agency thing. But it 12 would work more along the lines of the way the current 13 U.S. Pharmacopeia works. Where they developed basically a 14 model rule or something that's then adopted by their 15 appropriate agencies for use.
16 MR. KNAPP: Thanks for the clarification.
17 MR. CAMERON: And does that clarify everything 18 for you, Mal, on that issue?
19 MR. KNAPP: On that issue, yes. Thanks very 20 much.
21 MR. CAMERON: Okay.
22 MR. KNAPP: I appreciate the responses.
23 MR. CAMERON: Jim, did you have something you 24 wanted to add?
25 MR. WILLIAMS: Jim Williams from Ohio.
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223 1 I, I would think that this discussion might 2 harken back to pre-1974 concepts where NnC did it all.
3 AEC did it all and it was determined that AEC couldn't 4 regulate, develop, set standards, and do the whole 5 package. -
6 Therefore, the Nuclear Regulatory Commission 7 was founded and the Energy, Research and Development 8 Administration, and et cetera, et cetera, to down to the 9 DOE, divisions were developed.
10 So I don't think you would want to go back to 11 that concept where NRC was setting standards and enforcing 12 and regulating, because it seems like that's a regressive 13 step. ,
I 14 MR. CAMERON: Okay. I think before we turn 15 to, well, George, why don't you make your statement and 16 then I'm going to ask Steve Crockett of our office, a 1
17 general counsel, to just clarify what the legal framework l 18 on this. Existing framework.
19 MR. OLIVER: George Oliver, a medical 20 physicist working with the Unity Health System in 21 St. Louis.
22 When Mark made his statement a while ago, I 23 heard something different, I think, than what was 24 expressed by several people.
25 I heard him reference the ICRU and the NCRP.
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i 224 ;
1 1- These, in my point of view, are standard-making bodies l 2 that use ocientific fact, social relevance, ethics, and l
3 other factors. They are the kind of societies, technical 4 organizations, perhaps, that make standards. ,
5 I would argue that agencies make standards. I 6 think agencies regulate limits and I see a very distinct 7 ditf9rence there. ;
- 8 MR. CAMERON: Thanks, George. You just made i
9 Steve's job a little bit tougher, I think.
10 Steve, do you want to try to give us a I 11 framework here? ,
i 12 MR. CROCKETT: I hope I don't confuse things *
, 13 further than, maybe all the confusion is in my mind. '
i 14 But you do raise some very inte. resting ,
15 questions here about the degree to which scandard setting i i 16 and enforcement authorities.should be separated.
F
, 17 I should say right now that my own ;
18 understanding of the law is, and I think Chip would 19 probably agree with me here, the NRC and the AEC before it 20 had the power to set standards and to enforce them. And 21 when the NRC was, when the regulatory part of the AEC was 22 split off and, and formed into the NRC.
23 The separation they were trying to achieve i
24 there was not between standard setting and enforcement, l l
25 but between regulation and promotion.
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225 l 1 Now, I'm not, I'm not trying to say that it 2 wouldn't be a good idea, perhaps, to separate standard l 3 setting from enforcement. After all, the design of the 4 federal government itself and the design of cost state 5 governments begins with the idea that the standards are 6 set in the legislature and they're enforced by the 7 executive branch.
8 But I wasn't sure that anybody here was 9 proposing that radical notion of separation of powers.
10 The sum of what I've said so far is, we've got 11 the regulatory authority to set the standards. But I 12 think what'you're proposing here is that when we go about 13 that, or at least the message, the strongest message I'm 14 coming away from this discussion is, when we go about ,
15 setting those standards, we ought to be looking to a body, 16 to bodies that have always been recognized as being, I 17 don't want to say merely advisory, because they're really 18 much more important than that.
19 But they are professional bodies that have 20 continuity, they have the knowledge, and they have looked i 21 at these questions over and over again.
22 You saw in one of the earlier direction l 23 setting issue papers, a proposal that the NRC encourage 24 even more such interaction with such standard-setting 25 bodies and there's no reason that shouldn't be seriously l NEAL R. GROSS i
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226 1 considered in the medical area, too.
2 I'm coming away with a sense not that you're 3 proposing that our legal authority to set standards not be l
4 exercised, but rather that in the exercise of that 1
5 authority, we look to the many sources of expertise that ,
6 there are in the professional bodies and in the states.
7 Is that a fair rendition of at least what some l 8 of you are saying?
9 MR. CAMERON: Let the record note that two of 1 10 the previous commenters are shaking their head ]
. 11 affirmatively in response to,.to Steve's characterization.
'12 Thank you, Steve.
13 Frank? ;
14 MR. MIRAGLIA: Frank Miraglia, NRC. ;
15 Primary out of the reactor area and I think we
- 16 have an analogy that we could use in terms of codes and 17 standards, we heavily rely on codes and standards by 18 societies, the ASME, and those things.
19 I think the agency, NRC, traditionally in 20 terms of radiation protection, has always looked toward l 21 the NCRP and ICRP as the technical and acceptable base to 22 which to endorse standards. And I think that's what Steve 23 was just eluding to and I was just going to point that 24 analogy out, but Steve covered the territory very, very 1- 25 well. So I just wanted to add that as an observation. j NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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227 1 MR. CAMEP.ON: Thank you, Frank.
2 Since-we've been real) riding this horse of t
-3 option 1 here on the NRC '
m "* ' n , cegulatory authority I f i
4 for NARM, I guess I woul, '
o ask you, first of all, 5 whether anybody.has a different perspective on whether the l
! 6 NRC should regulate NARM and for those of you who are 7 recommending that we do that, since we don't by and large 8 have authority for it now, and never had authority for it, 9 how, what would be the mechanism for NRC to assume :
l
- 10 authority over NARM?
11 Is there any, any other perspectives on NARM i
12 and second of all, what would be the mechanism if we do i 13 try to go after it?
l L 14 I won't take the silence as the fact that 15 everybody thinks we should go after NARM. But, we're not l 16 hearing any other views, at least at this meeting. How j
- i l 17 about the mechanism? )
l' 18 Do we, Gordon, do you want to say something on 19 this?
20 MR. APPEL: I sort of came in in the middle of l
l 21 this. I mean, if you want to be, if you would like to l 1
j 22 hear the opinion that, from someone, or a state that ]
23 - believes that you should not regulate NORM, Illinois 24 clearly believes that you should not regulate NORM and j 25 NARM. That's the state's prerogative and it should be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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l 228 1 legt there. i
-2 That's all I have to offer.
3 MR. CAMERON: Okay. And-I'm not, I wasn't 4 trying to force any other perspectives out-on this issue, l 5 but it sort of leaves us with'an interesting dicophane. .
L 6 But, I guess we're done with, _I guess that, j l
7 that's the end of the NARM discussion, unless someone else 8 has something else to say on that.
9 Yeah, Kristin? l 10 MS. ERICKSON: I have one quick thing to add *
.1 11 to this. This is in addition to Kathy's comment that it 12 was very simple and I maybe gleaned a little ,
l 13 uncomplicated, to regulate these things and I'm going to !
14 disagree wholeheartedly. It is not simple to' regulate an 15 accelerator. There are far-more than a couple of !
16 isotopes, there are far more risks and unpredictable 17 situations of every type. Every type of radiation, alpha 18 beta gama neutron.
19 Energies and isotopes which you've never heard
'20 of. When I do a wipe and put it.on the gama spec, I see 21 isotopes none of you have ever identified. We created 22- something like 60 new ones a week or two ago.
23' And these issues, the hot parts, the hot l- 24 equipment, the maintenance of these machines in j i
1 l 25 particular, poses risks that I think most, most people who l
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l' 229 1 don't deal with these machines are aware of. And can, and 2 in fact, our State people are not aware of, they're 3 learning together with us. We bring them out and work 4 together to show them on site what happens.
5 So I think this is something that should be l
6- brought to the attention of the NRC that it isn't going to 7 be a simple little thing, that it will take staff, but it 1
8 certainly can be done and it can be done well within the 9 framework of the NRC regulations.
l 10 So I still support that they would, that they 11 would oversee and regulate. I think they're the best 12 agency.
13 And finally, I want to comment on whether we j 14 have one agency for all things. I would be thinking I 15 died and went to heaven if we didn't have five or six Anr 16 seven different agencies regulating us with different l
17 rules. DOT now wants us to use international units and 18 NRC, of course, is on old special units.
19 All the way across the board we have different 20 agencies telling us different things and then they change 21 them all the time. And that's tough. We'd like to see 22 one agency or at least a complete consortium memo of 23 understanding between all the agencies and they agree on 24 how they're going to do it and do it the same way.
25 MR. CAMERON: Go ahead, Mal. '
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230 1 MR. KNAPP: Just as a little bit of a side 2 bar, the federal agencies, with some help from the State 3 Observer, Bill Dornsife, are trying to harmonize risk and j 4 harmonize in a number of ways the way we work.
i 5 Any comments, not necessarily on this DSI, but 6 on. the subject in general, such as difficulties or
-7 contradictions among agencies. Certainly.if you would 8 send them in and, because I'm a participant in that group, 9 you can send them to me and we vould try to, as we have ;
10 resources available, consider ttem and try to make life .
11 easier.
12- MR. CAMERON: And I would just add on that 13 either for now or when you submit a comment, if you do ,
14 support the NRC assuming regulatory authority for NARM, if ,
i 15 you could provide the rationale, whether it should be 16 national uniformity or to fill gaps where some states are 17 not regulating it now, or whatever the rationale is. That 18 would be, that would be helpful f or us. !
4- ;
19 Cheryl, you said that you had some other stuff )I 20 that you wanted to, to say. I shouldn't characterize it 21 as stuff, but do you, do you want to give us a few more 22 comments? ;
i 23 MS. SCHULTZ': Not, I'm not completely 24 satisfied with what I said and I was curious if anybody j 25 else in this room, I'm curious if anybody else in the room NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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231 1 appreciates the point of view that I presented about the 2 regulation of radiation safety for patients.
3 MR. CAMERON: That's, that's a good, good 4 question and it takes us back to some of these other 5 options and the Commission's preliminary views.
6 Do we have, do we have some comment for Cheryl 7 on , on that issue of, I don't know if I, do you want to l 8 quickly characterize that again? That patients shouldn't 9 be treated as members of the, of the public. Why don't 10 you continue?
11 MS. SCHULTZ: I just feel that from our 12 hospital's point of view, that there is a conflict related 13 to the fact that we have regulations out there that are 14 specifically directed toward radiation safety of patients.
15 And the conflict comes in when you consider 16 the fact that the patients are coming in specifically to 17 be treated with radiation. And so all.those regulations 18 cause conflict between the practicing physicians, the 19 healthcare workers at the hospital, and the NRC.
20 And I think we go a long way if we could 21 resolve that issue because really, we've had a very 22 excellent with the Nuclear Regulatory Commission over the 23 years, we have a very good program. And I think the NRC 24 does a tremendous job in what they're doing.
25 But I certainly appreciate the physician's
(
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232 1 point of view as new modalities come up. It's very l
2 difficult for us to get approval for some of these 3 procedures. The patients are lined up at the door, t 4 they're waiting for these things to be used.
i S' And we need to work together to be more, if 6 you're going to regulate the patient in radiation safety, 7 you need to be more attune to the patient's needs.
8 And I do think there is a point you can make 9 of separating medical use of radiation in the direct 10 patient care environment from all these other issues. I 11 think there's, you can make a very strong case for that.
12 And I think that's what'the National Academy 13 of Science recommendation was about. Was getting toward 14 that. Achieving that goal. Of recognizing it's different 15 when you're a patient. l 16 Okay, now, as far as our workers in the 17 hospital and as far as the rest of our program goes, we 18 would of course want to continue to comply with the 19 regulations.
20 But I guess that's just the point I was trying 21 to make is, and get your opinion on this. What is the ;
22 goal of regulating radiation eafety for the patient?
23 MR. CAMERON: Okay. That's, I think, a 24 question that goes to the root of this and does someone 25 want to give an answer or their viewpoint on Cheryl's l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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233 s
1 question?
2 I don't know if Mal, if you want to jump into x
3 that right now or not. If you feel inclined, go ahead.
4 MR. KNAPP: I rush in where angels fear to 5 tread.
6 I think our view in patient, taking care of 7 the patient, is in the event that we would have a, you 8 know, significant, I mean, let me back up.
9 Obviously we're not trying to limit the 10 patient's dose to the dosage you have from an average 11 member of the public. Obviously you're right, they're in -
12 there to be treated and we don't want to interfere with 13 that at all.
14 I think the question arises as to when there 15 is what we might call a gross misadministration. A 16 physician prescribes 2000 RAD and maybe the physician has 17 in mind, well anything greater than about 1400 or less 18 than about 3000 is probably about right because of their 19 understanding of the impact of the radiation. And then we 20 have a patient that as a result of an error, gets 2000 21 RAD. Unfortunately, they give it to the wrong patient.
22 Is this other patient a member of the public?
23 Because this person didn't come in to get radiation l
24 treatment at all, yet because they messed up the tags, l 25 that happened.
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234 1 1 think that's at least a part of the concern ,
2 we have.
I 3 MS. SCHULTZ: That's a valid concern, but J
4 certainly, when you look at the use of radiation in a 5 hospital setting in a direct patient care setting, there 6 really isn't very much difference between that kind of an 7 error or a chemotherapy error, or a pharmaceutical error, 8 and all of these are handled much differently, without a 9 Nuclear Regulatory Commission in, gaining access to 10 patient charts that are patient privacy, and making i 11 sometimes decisions or recommendations that I believe, and 12 the hospital believes, are inappropriate in that setting.
13 And certainly reporting a misadministration, 14 first of all, the word misadministration is very 15 disturbing. And it's, it's a very big problem when you 16 have a patient that's being treated, for example, for 17 cancer, and that patient inadvertently loses the source, 18 whether they pull it out or it falls out by some process, 19 this then has to be reported as a possible 20 misadministration.
21 When you get into the whole process then, it 22 becomes extremely difficult dealing with that patient, the 23 patient's family, trying to describe to this patient, 24 well, we're reporting this to you because an error was i i i
I 25 made and the error happens to be called this word, l
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1 misadministration. And this is very disturbing to the 2 patient.
3 And it's a gray zone we're required to report, l_ 4 regardless of whether we know it was a patient-related l
5 incident or not. And I really question the need for this.
- 6 And the word misadministration should definitely be thrown l 7 out and another word should be substituted. Because it is l
8 misleading and disturbing to the patients.
l 9 MR. CAMERON: Okay. Thank you, Cheryl.
t 10 MR. KNAPP: The problems-you raised are ones 11 that trouble us a great deal, too. And whether or not l
l 12 misadministration is an appropriate word is certainly a 13 question we are asking ourselves.
14 I guess I would ask in the comments, you 15 mentioned it was a gray area. Any particular place where 16 you think it would be appropriate for the NRC to draw the 17 line, we'd like to hear that. We'know about the concerns 18 of the various sub-parts of part 35 and what we're looking 19 for is, where do we strike the right balance between 20 appropriate protection and interference unnecessarily, 21 interference which causes anxiety inappropriately.
22 So, yeah, we'll be very pleased to hear your 23 comments.
24 MR. COLLINS: Steve Collins from the Illinois s 25 Department of Nuclear Safety.
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236 1 Illinois agrees with her comment or concept i
2 that when the patient, particularly a therapy patient 3 receives the wrong dose to patient's intervention by l 4 patient accidentally or on purpose removing the sources, 1
l 5 and we do not classify that as a misadministration or the 6 better term that we use, reportable event.
7 MR. CAMERON: Thank you, Steve.
l 8 Now, Kristin.
9 MS. ERICKSON: This comment is going to come 10 from me as a citizen and a member of the public and a 11 former patient.
12 I had malignant melanoma 18 years ago. At the 13 time I was breastfeeding my daughter, who is.now 18. I 14 had the whole nuc med procedures afterwards. At that time 15 the regulation wasn't as strict as it is now, there wasn't 16 as much QAQC or training or anything else.
17 After the procedure, I knew a little bit about 18 radiation, I said, well, now, I shouldn't breastfeed my 19 daughter, should I? And they said, oh, go ahead. Don't 20 worry about it.
21 Well, I didn't. Because I happened to be 22 educated enough to'know better. What shocked me, and this 23 was a reputable, fine hospital in the Ann Arbor area, not 24 U of M.
25 The thing was, I thought about all those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N.W.
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-l 237 1- members of the public who don't know anything about 2 radiation or about medicine or about any of those things, l
3 who went ahead and did feed their baby. You know, these l 4 are things that today now I look at this in retrospect and 1
5- think, now, if we scale back, as a citizen and a member of l 6 the public in this comment, I'm saying this is something 7 we really need to look at carefully.
8 There are still big issues and I hear a lot of ;
5 RSO's complaining that the big broad licensed institutions 10 about the M.D.'s who absolutely refuse to cooperate-in.any 1 11 shape with radiation safety. regulations as they exist.
12 Whether.they're the state or the federal regulations' .
13 They have trouble with these guys, some of them refuse to t
14 wear.their badge. Some won't badge their students who are 3 15 in the room. And they're battling these people a lot, 16 They don't want to clean up a contamination.
)
17 They, they all believe that they're above the 18 law and that isn't-every doctor or every institution, but 19 it is something of a problem and my concern, both as a 20 citizen and now as the RSO, is to say that if we take away 21 any regulation at all, then the institution, the safety 22 managers, have no teeth whatsoever. No clout, no means i
23 other than please do this. It's a good thing to do or I 24 want you to do this or it's the right thing to do.
25- So this is something that if it were to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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238 1 happen, I would recommend that we continue to strive
- 2. towards less regulation from looking again at the risk 3 based approach. But not to completely remove the 4 regulation from medical. Any more than we would from 5 other radiation safety things.
6 If we're going to think about adding more 7 regulation and oversight to things like NARM, contaminated 8 sites, decommissioning, we're even looking at some natural 9 things now. Why would we suddenly say that only one part 10 of this shouldn't be regulated at all?
11 So that's the comment I have.
12 MR. CAMERON: Thank you very much, Kristin.
'13 Steve?
14 MR. COLLINS: Steve Collins with Illinois 15 Department of Nuclear Safety.
16 As a person interested in writing regulations 17 that are appropriate to the need and the risk and all, I j 18 would be interested to know if she had any suggestions 19 with regard to, does she think, as the former patient and 20 concerned citizen, and a mother, that it's appropriate for 21 a occupational radiation protection setting agency that's 22 also interested in public health ant safety standards 23 being set. Is it appropriate for that agency to be the 24 one that sets the standards that protect the patient and 25 the unborn child? Or would that be better regulated by j NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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239 1 someone else who regulates the rest of the practice of 2- medicine? l l
3 My, my view is that comes under the practice 4 of medicine area and they should have been more careful to 5 be advising you properly. But it's not the radiation 6 protection program for the' state or the. federal agency 7 that's involved. Mostly in worker protection and in 8 protection of the public from effluence basically.
9 And.that, agencies with that expertise 10 basically shouldn't be meddling into the board of medicine 11 or board of pharmacy type areas that are more 12 appropriately regulated there.
13 So if she wishes to make any comments with 14 regard to what she feels is most appropriate there because 15 of her technology expertise as well as the other 16 experience, I'd like to know.
17 MR. CAMERON: I think you are going to get'a l
18 response. l 19 MS. ERICKSON: Your point is really well 20 taken. And looking at it from, like I'm saying, many 21 angles now, I do believe that the medical people should 22 regulate these things. They should make these decisions. l 23 But so many tim a, there are M.D.'s and medical people who 24 are so unfamiliar with radiation and its risks, its 25 effects. I have the most ridiculous questions come to me NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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240 i from even M.D.'s, veterinarians, patients who have been 2 told something by an M.D. They are not getting good 3 education in these things.
4 And until, I mean, that is, again, it isn't 4
5 every M.D. or every veterinarian, or every medical 6 practitioner. But until we have better education in these 7 areas for these people in radiation protection, that I 8 think that it should be done in tandem with some outside 9 assistance, oversight, or spot-checking, something or 10 another, so that we aren't just totally pulling out.
11 If we do that eventually, that's a good goal 12 and I do think that the M.D.'s and the' medical community
' 13 should regulate these things. I think they can do it.
t 14 But until things are in place, I think there's got to be a 15 joint effort.
16 MR. CAMERON: Okay. Now, this has been an
-17 interesting discussion and I guess the last of the 18 exchange between Kristin and Steve raises the issue of 19 perhaps there's another way to try to, to regulate or 20 guide the practice, rather than vary prescriptive 21 regulations to try to ensure that the people who regulate ,
22 every other aspect of medical care at the hospital are
- 23 indeed knowledgeable about that.
24 I mean, there's other options besides 25 prescriptive regulations.
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241 1 Cheryl, you started this off, do you, do you l
2 have any final words on this? Or any last words? !
l 3 MS. SCHULTZ: I just can't wait.
4 No, my final word is that I am very impressed with the radiation safety program we have at our hospital. !
l 6 As I said before, we're the sixth largest, but we actually ;
I 7 have two hospitals and several off-site facilities.
l l
8 And we have a very dedicated radiation safety I 9 committee and these members of this committee have made ,
i 10 the commitment to have one unified radiation safety 11 management program for our entire system. And this is l 12 working extraordinarily well and what this is means is we- j l
13 have uniform-type of rules, procedures, for all radiation 14 workers, regardless of whether they're working in the 15 radiology department, therapy, out in the research labs, 16 what have you.
17 And the physicians are very cooperative. They ;
i 18 are very knowledgeable, we have an excellent training 19 program. And in our little cosmos, if you will, I see 20 that we actually could serve as a little bit of a model 21 for this idea of unifying, if you will, in medicine the 22 regulation of all uses for the express purpose, which is 23 the benefit of the patient.
24 And that's all I really wanted to say.
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242 1 and thatt% all of you. That was a very thoughtful and i 2 constructive discussion on a number of complicated issues. l 3 l l
4 And Mal, unless you have any final things to 5 say, I guess we-can wrap up and be back here at 8:15 !
6 tomorrow. Mal? Go ahead. ;
7 MR. KNAPP: Only comment, I'm not sure whether 8 it's the timing or the people but this is one the most 9 effective discussions we've had. Thank you very much.
l 10 (Meeting adjourned at 4:32 P.M.) '
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CERTIFICATE l This is to certify that the attached proceedings before the United States Nuclear 1
' l Regulatory Commission in the matter of: '
Name of Proceeding: STAKEHOLDERS PUBLIC MEETINGS BUILDING PUBLIC TRUST AND CONFIDENCE Docket Number: N/A 1
Place of Proceeding: ROSMONT, ILLINOIS
, were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and, thereafter reduced to 1 typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.
V1V m u"
/RON LeGI6LND
, Official Reporter
- Neal R. Gross and Co., Inc.
I 4
d NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS i
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