ML20148L160
| ML20148L160 | |
| Person / Time | |
|---|---|
| Issue date: | 06/13/1997 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9706190095 | |
| Download: ML20148L160 (74) | |
Text
!
o ?CK ORIGINAL UNITED STATES OF A.MERICA NUCLEAR REGULATORY COMMISSION
Title:
BRIEFING ON MEDICAL REGULATION ISSUES Location: Rockville, Maryland Date: Thursday, June 13,1997 Pages: 1 - 59 ,
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DISCLAIMER !
This is an unofficial transcript of a meeting of l the United States Nuclear Regulatory Commission held on June 13, 1997 in the Commission's office at One White Flint North, Rockville, Maryland. The meeting was open to public attendance and observation. This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
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The transcript is intended solely for general informational purposes. As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the
, matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or i
beliefs. No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as 1
the Commission may authorize.
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1 1 UNITED STATES OF AMERICA l
l 2 NUCLEAR REGULATORY COMMISSION '
1 3 ***
4 BRIEFING ON MEDICAL REGULATION ISSUES 5 ***
i 6 PUBLIC MEETING l l
7 ***
8 Nuclear Regulatory Commission !
l 9 Commission Hearing Room 10 11555 Rockville Pike
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11 Rockville, Maryland )
12 13 Thursday, June 13, 1997 14 15 The Commission met in open session, pursuant to ;
16 notice, at 9:00 a.m., the Honorable SHIRLEY A. JACKSON, 17 Chairman of the Commission, presiding. i 18 l l
19 COMMISSIONERS PRESENT: i 20 SHIRLEY A. JACKSON, Chairman of the Commission 21 KENNETH C. ROGERS, Member of the Commission 22 GRETA J. DICUS, Member of the Commission 23 EDWARD McGAFFIGAN, JR., Member of the Commission 24 NILS J. DIAZ, Member of the Commission r
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2 j l 1 STAFF AND PRESENTERS SEATED AT COMMISSION TABLE:
I 2 KAREN D. CYR, General Counsel 3 JOHN C. HOYLE, Secretary 4 HUGH THOMPSON, JR., Deputy EDO 5 CARL PAPERIELLO, Director, NMSS ,
l 6 DONALD COOL, Director, Division of Industrial & !
7 Medical 8 Nuclear Safety, NMSS 9
1 10 11 12 13 14 15 16 17 18 19 20 21 22
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1 PROCEEDINGS 2 [9:00 a.m.)
3 CHAIRMAN JACKSON: Good morning, ladies and 4 gentlemen. Today the NRC staff will brief the Commission on -
5 its proposed program for revision of 10 CFR Part 35, Medical
! 6 Uses of Byproduct Material.
i 7 In a March 20, 1997, Staff Requirements Memorandum 8 the Commission directed the staff to submit a program for l
9 Commission approval for revising 10 CFR Part 35 and 10 associated guidance documents and the Commission's 1979 l 11 Medical Policy Statement, if necessary.
12 The staff's proposed program was submitted to the 13 Commission in SECY-97-115 dated June 5, 1997, and currently 14 is under review by the Commission.
l 15 Today's presentation provides the Commission with l 16 an opportunity to request clarification from the staff i 17 regarding specific issues of individual concern by the 1
i 18 Commissioners as well as for the staff to provide l 19 preliminary feedback to the Commission gained from its i 20 recent meetings with professional organizations. j l
21 We look forward to hearing from the staff on its 22 program for achieving the goals of the SRM. I understand 23 that copies of the paper and slides are available at the 24 entrances to the meeting room.
l 25 Unless my fellow Commissioners have anything to ANN RILEY & ASSOCIATES, LTD.
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4 1 add, Mr. Thompson, why don't you begin.
2 MR. THOMPSON: Thank you, Chairman Jackson. I 3 appreciate the opportunity to meet with the Commission this 4 morning. This is one of the most important rulemaking 5 activities that we have underway, particularly in the 6 nuclear material side of the house.
7 Part of the reason is the current Part 35 has 8 been, as you know, one of the more controversial activitias, 9 and our program had really been to strive to achieve early 10 widespread input from the medical community as well as the 11 other affected parties, such as the Agreement States and 12 members of the public, since this is where radiation is 13 intended to be delivered for good purposes, and we obviously 14 have the issues associated with the practice of medicine and 15 not interfering with the practice of medicine.
16 With me today is Dr. Paperiello, who will have 17 some opening remarks, and Dr. Don Cool, who will be the 18 primary presenter.
19 We are aware of the Commission's concerns with 20 respect to the timing in the current paper, and we are 21 prepared to address that issue and provide some alternatives 22 if the Commission would be interested in ways that we are 23 able to address the alternative approaches to accelerate the 24 time frame in which this rulemaking could be conducted.
25 Carl.
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5 1 MR. PAPERIELLO:
i Dr. Cool is going to make the 2
presentation for NMSS, but I want to basically describe the 3 issue on the time line and how we got there.
4 The rule is going to be complicated because of the 5 volume of material, and it's not just the rule, but the 6
licensing guides and the standard review plans that we are 7
going to prepare for all modalities to go in parallel with 8 the rule.
9 When the Commission paper came to me last week, 10 the proposed time line met the Commission target of 11 completion by June of 1999, but each of the three periods 12 for public comment that I was given were so short, 45 days, 13 that with the volume of material to be reviewed, I feared we 14 would be accused by the medical community of deliberately 15 not giving them adequate time to review all of the relevant 16 material. So I directed the staff to add more time for 17 input. The paper went forward.
18 After discussions lEst Friday, I realized that 19 while I had been very conscious of the Commission direction 20 to consider a rulemaking process that provides more 21 opportunity for input from potentially affected parties than 22 is provided by the normal notice and comment rulemaking 23 process, I was less sensitive to the Commission target date.
24 Subsequently we have prepared a revised time line l
25 that I believe ought to meet both goals with a little 1
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6 We have to present this as a backup 1 technical innovation. ;
h 2 slide. l I
3 What we would do is drop one of three rounds of facilitated meetings and public comment period. We would 4
5 use the Internet as a forum to present the rule as we 6 actually draft it and invite continual public comment on it .
7 as we write it. Then the Commission would get the proposed I I
8 rule by next May, and assuming the normal rulemaking process l 9 thereafter, we would meet the target date of mid-1999.
10 CHAIRMAN JACKSON: You have this in a backup j l
11 slide?
l 12 MR. PAPERIELLO: Yes.
13 CHAIRMAN JACKSON: Why don't we hear your plan 14 overall and the feedback you have gotten, and then let's 15 revisit it with your backup slide again.
16 MR. PAPERIELLO: That's what we would propose.
17 MR. THOMPSON: Don.
18 MR. COOL: Thank you.
19 Good morning. If I can have the first slide.
20 [ Slide.)
21 DR. COOL: Things that I wanted to try and touch 22 on today very briefly was the plan program, as the Staff 23 Requirements Memorandum had indicated.
24 Some of the conceptual ideas that we have been 25 looking at and discussing with various groups, the states, ANN RILEY & ASSOCIATES, LTD.
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and several of the medical societies already.
2 Some of the feedback that we got from those groups 3
that they told us over the last couple of weeks.
4 So that's roughly where we are going to be going.
5 The next slide, please.
6
[ Slide.]
7 DR. COOL:
To try and provide right at the very 8
beginning some of what you mentioned in terms of 9 clarifications.
10 We have used the words " enhanced participatory 11 rulemaking" a great deal on the advice of the Special 12 Counsel for Public Liaison and the folks in OGC, who 13 indicated to us that any time per the SRM direction we get 14 beyond the formal Administrative Procedure Act process we 15 are enhanced in some mechanism.
16 Having said that, the degree to which it is 17 enhanced, the mechanism by which it 18 is enhanced are all open for consideration, debate, modification, and otherwise. We 19 took an approach, as I am going to be going through in a few 20 minutes, which had several opportunities, each of which had 21 specific reasons.
There were pros and cons for each one of 22 those.
23 The second term that was used, which I think may 24 well have been misconstrued, was the phrase " blank piece of 25 paper."
That was not an indication that we had an empty ANN RILEY & ASSOCIATES, LTD.
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let folks at l
l head or no ideas, bu2 rather an opportunity to l
1 y formal 2
the beginning stages of the process, before an provide views with regards 3
drafting had been written down, 4
to how they would write the rule In certain specific areas there are some places, to go and get industry codes and 5
6 as the SRM directed us, events; a standards and practices; how to capture precursor 7 d us for where 8
couple of the other items that you have aske (
into the levels of detail, while there are some 9 as you get detail of 10 conceptual ideas that the devil is always in the that was our 11 exactly how you write it and where you stop, f T 12 intention in terms of providing them an opportunity "the be ore 13 already seeing language which might be construed aswe concrete already poured; perhaps we can change the way 14 it's already there" and 15 mark the lines on the sidewalk, but ies for 16 provide that opportunity as one of the possibilit 17 enhancing the process.
Yes, Commissioner.
CHAIRMAN JACKSON:
18 I want to pursue this.
COMMISSIONER McGAFFIGAN:
19 the 20 I've listened to you and to the medical community for On a lot of issues there is a 21 nine months I have been here. isn't; and on 22 tremendous commonality of views; on some there in a 23 some the Commission and the staff may well end up 24 different place in the medical community.
25 It strikes me that the comments we have received LTD.
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thus far -- and you have been receiving comments for four or 2
five years on this subject -- have been all up here at the 3 level of grand vision.
I haven't seen anybody getting down 4
to saying Part 35, section 1202 should read as follows.
5 I think the game that has to be played is somebody i i
6 has to be brave enough to write those words down without 7 saying this is locked in concrete.
8 I used to go through this in acquisition policy.
9 We need to do more commercial-like activity, use more 10 commercial activities. No one ever said that means in Title 11 10 U.S. Code 2503 you need to write it as follows, until we 12 had what was called the Section 800 Panel.
13 In order to get from grand vision, Packard 14 Commission visions down to what does Part 35, section 1202 '
1 15 look like, you have to put something down on paper. In my 16 view, it's all a matter of how it is put on paper and the i 17 degree to which you give any indication that this isn't 18 anything but a discussion draft, that this is truly a means 19 to get people focused as opposed to this is our final word 20 and we are going to be willing to change the adverb "maybe."
21 CHAIRMAN JACKSON: Did you have some issues that 22 you were prepared to pencil in? Pencil as opposed to pen 23 in. Where you planning to proceed along the line that the 24 Commissioner has --
25 MR. COOL: Yes. In fact I agree with him 1 l
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10 I talked about with 1 completely. That is specifically what 2 ACNP/SNM last week. That's what I talked about this week ht 3
with the American College of Nuclear Physicians; that's w a this year's CPD 4
we talked about with the Agreement States at I
l 5 meeting: the time for the high ideas was done; we need to 6 have draft language; and that's what we need to try and 7 proceed with.
The object here was to try and get exactly that.
8 sort 9
You've always got people who are not going to do that of thing. They're going to stay up at a higher order level, 10 a few folks who would get 11 but our hope was to have at least 12 down, would go back, as I think you suggested to the ACMUI, 13 take a look at your license, take a look at the rules that 14 pertain to your area and write me a draft.
We were really in hopes that we would have several 15 We .ieren't going to be 16 of those folks, staff included.
17 sitting there going, well, let's see what they bring us and So I had a melting pot and 18 try and crank our own ideas.
19 poured them all into the pot of specific language so that we 20 could stir them around to try and come up with a draft.
You can speak for yourself, but 21 CHAIRMAN JACKSON:
the question becomes, 22 in order to move the discussion along, if all of that solicitation from the interested parties 23 doesn't work, are you prepared to pencil as necessary to get 24 25 the conversation going?
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!- 1 MR. COOL: Absolutely. We are not only prepared 2 'but planning to do our own cut on the version along the way 3 as they were giving us versions.
4 MR. THOMPSON: I think we are actually getting a 5 -large' degree of enthusiasm on the' industry's part to l
'6 participate in this. That's the good news.
7 CHAIRMAN JACKSON: The not good news or the 8 question that follows from that is -- and as you point out, l 9 you've heard me say this to individuals who have come -- we 10 have to put some pencil to paper here. If they have some l
- 11 specific idsas, they need to come forward with them, and if- {
L 12 not, then you are prepared to lay some issues on them. {
i 13 MR. COOL: We're ready to go do. Yes, ma'am.
14 CHAIRMAN JACKSON: I think Commissioner Dia: has !
15 something.
I l 16 COMMISSIONER DIAZ: It's in the same vein. It's 17 on the issue of what you put out there first, something that t 18 already has some direction so people can see where we are l
19 going, and then have people write, change and everything.
20 It's in the same vein.
- 21 COMMISSIONER McGAFFIGAN
- I think this is a good l
l 22 discussion, and hopefully the community hears it. Another 23 way to try to shorten things and yet have people focused on 24 the level of detail you need is to perhaps even put options 25 out there. You said earlier Internet. You can have options
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t 12 1 A and B and C and have people discussing the options. There 2 is no better way to imply that you have an open mind than to 3 have several options, if indeed all of them look viable.
4 MR. COOL: I think we will go ahead and proceed.
5 A number of the things that we heard in the meetings over 6 the last few weeks bear on this point, and I'll get back to 7 them when we get down to the slide on what we heard out 8 there.
t 9 Go to the next slide.
i 10 [ Slide.] ,
11 DR. COOL: Conceptually the proposed steps of this 12 plan was to provide two additional opportunities in a more 13 formalized sense to interact with the community, with the 14 states and others during the development phase, before there 15 was the formal proposed rule process, 16 The first of those, an early input phase, as we 17 have been talking auout, to try and get people to give us 18 very detailed specifics, their version of the rule so we 19 could stir those together.
20 To try and develop those more refined into a set 21 of options, because you will always have some measure of 22 shotgun. The more controversial the issue, the greater the 23 spread of the BB's. [
24 To provide the Commission an opportunity to take a 25 look at what has been developed and the sort of options on ANN RILFV & ASSOCIATES, LTD.
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1 the table as a mechanism of ensuring that if there were some 2 that we needed to say, well, that scatters a bit out of the 3 range that we would really like to consider, that we would 4 have that opportunity.
5 Then to go in in a second round of some 6 facilitated discussions, sit around the table and say, i 7 here's some language, here are some alternatives, here are l
8 some particular concerns. Training and experience will be i l
l i 9 one of those, I think, and some of the others. And to i 10 hammer around on that language such that the proposed rule 11 that would come forward would have the benefit of those 12 discussions, would have the benefit of the input and 13 activities such that I would hopefully be able to represent l 14 to you that there was, while not consensus, because there is l 15 just simply too wide a range to ever hope that you would 16 actually be able to have a consensus from the various and j 17 divergent groups, but at least a strong central tendency j l
18 towards the things that were being brought forward as an !
19 actual proposed rule.
l 20 CHAIRMAN JACKSON: You mentioned in your paper the 21 possibility that the public meetings you might have i
! 22 facilitated by a contractor.
23 MR. COOL: Yes. i l
l 24 CHAIRMAN JACKSON: Have you given any thought to j 25 having the actual working group sessions when you are trying I i
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14 1 to resolve what may be quite juxtaposed positions also 2 facilitated to help you see what the path through the forest 3 is?
MR. COOL: Had not directly, although that is 4
5 cartainly an option. The working group -- and we'll get to 6 that in a minute -- of stat
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18 1 proposed to use on each of those phases.
2 COMMISSIONER DIAZ: One comment on the 3 presentation. If I walk in and look at this, it looks the
}
Don't 4 very first thing you are going to do is public input.
5 you think there should be a big rectangle on the top that 6 says the process that we already have gone through with 7 time, all the things that actually come before the public 8 input? We have been working on it for years.
9 I know you know. I know you have been working on 10 it, but it doesn't strike me as right to start with public 11 input. It should start with a massive analysis and things, 12 and then we solicit public input.
13 CHAIRMAN JACKSON: High order concerns and issues.
14 Then public input.
15 MR. COOL: Should I go ahead and proceed?
16 CHAIRMAN JACKSON: Please.
17 MR. COOL: The next slide, please.
18 (Slide.]
19 DR. COOL: In terms of the actual staff 20 development work, the proposal entails the use of a steering 21 group / working group format. This is something which is 22 actually in the management directive for development of 23 rulemaking. It has been used on a number of occasions, Part 24 20, the decommissioning criteria, some of the NRR financial 25 assurance documents, and otherwise.
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19 1
There are a couple of new little pieces to this.
2 While we have had Agreement State individuals participating 3
in a variety of groups, adequacy, compatibility and a 4
variety of others, this would, I think, be the first time 5
where we had asked someone from the states to actually 6
participate on a group that was actually drafting a 7 regulation.
8 We found that to be a rather important component 9 to us, for a couple of reasons. There are now 30 agreement 10 states out there. The states were very interested in 11 participating, and we wanted to get their input in an 12 ongoing process. The individuals nominated, including the 13 individual who is on the CRCPD, suggested state regulation 14 group to try and have a close liaison to that activity.
15 The organizations also suggested to us that one of 16 the individuals be from a non-Agreement State. Although the 17 actual individual nominated is in sort of the middle zone, 18 being from Ohio and well along in the process to becoming an 19 Agreement State, I think in fact their projected schedule 20 could have them be an Agreement State before 1999 and the 21 actual date of this rule.
22 To have that view and flavor because of the impact 23 that this rule has traditionally had, and others, with all 24 of the other things that happen in medicine and some of the 25 difficulties that have been experienced in times past, some l
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of the things in misadministration definitions and a variety where the states go back and look at those 2 of things, 3
definitions and say, well, that's really nice if you are t'lking about this little box over here that is AEA.
I have 4
5 co have a set of regulations that deals with this box and 6
deals with these other boxes associated with the x-rays and 7 otherwise. If you just change these few things over here, 8
then the definition could have been more uniformly 9 applicable.
10 So our suggestion as part of this plan was to 11 involve those people in the drafting process.
12 The steering group, which I would chair, Also the suggestion 13 management level folks to review this.
14 to include someone from the states, probably a program director level person, to again provide that kind of input.
15 16 This is a new wrinkle to the process, although not entirely 17 new in the sense that the impact management review boards 18 have a state program person who serves on each of the boards 19 in a liaison capacity.
20 We have tried to take some of these ideas that 21 have been generated in other forums, and this is, very 22 frankly, the first time that it would be attempted in a rule 23 process.
24 We also are very much in hopes to use some 25 consultants and to heavily use the Advisory Committee on ANN RILEY & ASSOCIATES, LTD.
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21 1 Medical Use of Isotopes; the medical visiting fellow, who 2 was still within the NMSS staff; have each of these folks '
3 playing key roles, writing down immediately their particular 4 areas; Myron Pollycove, our medical visiting fellow, a i 5 wealth of experience, particularly in the therapy area with !
6 unsealed materials, one of the areas where there will be 7 some controversies in training and experience and otherwise.
8 So in hopes to reach out and get a number of these folks, 9 1 We have been working with the Office of General !
10 Counsel in terms of conflict of interest and how to deal j 11 with some of those kinds of issues, because obviously the 12 people who have the immediate information and have the l
13 online experience are also the people who are going to be i
14 affected by the rule. So we have to walk a little bit of a 15 careful line in that process.
16 Go to the next slide, please.
17 [ Slide.]
18 DR. COOL: Getting back to the point that ceveral 19 of you have already made, there is a lot of data. There are 20 a lot of things out there. We have been and need to 21 continue to pull, distil, gel a number of things which we 22 have our hands on: the event databases; our experience in 23 inspection and enforcement; some of the analyses that we 24 have done, such as what happened in terms of the quality 25 management rule and some of those other activities.
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22 1 We have been trying to establish and I think have 2 been successful in establishing some contacts The International Atomic Energy Agency and
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3 internationally.
4 some of the things that are going on in that arena. Our 5 understanding is that the European Community is revising 6 some of their directives in this arena more or less in 7 parallel, although I think they are slightly ahead of us.
8 Have some contacts there to try and establish and have some 9 liaison there.
10 The variety of professional societies, the states 11 and organizations, and the whole range of the various 12 subgroups that are out there, to try and tap into databases 13 and information which they have, including, for example, 14 some of the accreditation processes, JCHAO and some of the 15- other folks, which may have pieces which could serve as 16 models for a more performance oriented examination of what 17 might be useful to us as we look at enforcement, as we look 18 at credentialing.
19 CHAIRMAN JACKSON: Commissioner Dicus.
20 COMMISSIONER DICUS: On the professional 21 societies, I noticed in your paper you listed quite a few as 22 potential sources of contacts, and so forth. But absent 23 from that list was anyone representing pharmacies or even 24 the medical technologists Is that intentional or did you 25 just not consider that?
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23 1 MR. COOL: The list was a short list so as not to !
l 2 have a long paper. I have signed over 50 letters to a much !
l 3 longer list of various societies and otherwise, including f 4 folks in that arena, asking for opportunities to meet with 5 them; our interest in interacting with them through this 4 6 process. We wrote a sort of short list of the bigger ones.
l 7 That is not intended to be inclusive or exclusive.
8 COMMISSIONER DICUS: So you are including the l 9 radio pharmacies?
i 10 MR. COOL: We would very much want to do so, yes. !
1 11 COMMISSIONER DICUS: I may have another question :
1 12 about that. We'll come back to it. !
13 MR. COOL: The next slide, please. I 14 [ Slide.]
15 DR. COOL: Continuing along the same vein, there 16 are a number of things which have floated around which have 17 been sitting in limbo, if you will, in various stages.. Some 18 of the things which came out of the Indiana, Pennsylvania, 19 event from several years ago where a brachytherapy source 20 broke off from its wire and remained in the patient. A 21 number of the action items came out of that. That was the 22 actual genesis even of the medical management plan. !
l 23 There are a number of rulemakings that were tossed 24 onto the table at various times. As the SECY paper 97-062, l t
25 which came up a month or two ago with the semiannual l l
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24 1 rulemaking update, indicated in that paper, the intention -
2 would be to subsume those more individualized actions into 3 the overall revision and deal with them. Again, there are 4 background documents and thinking that has gone into some of 5 those which would be incorporated.
6 There have been some other issues papers that have 7 been generated to try and lay out ideas and thoughts in 8 brachytherapy and some of the other areas.
9 There are nome of the internal staff audits, the 10 one that Dr. Paperiello did a couple of years ago, and seme 11 others.
12 Again, there are a whole bunch of things which are 13 already on the table and serve as a baseline for this 14 activity.
15 Next slide, please.
16 [ Slide.)
17 DR. COOL: Having said all those things, there are 18 a series of issues. This again is not meant to be all 19 inclusive, but some of the bigger ticket items, some of 20 which match items which are in the Staff Requirements 21 Memorandum, some of which will be on that.
(
22 We are specifically looking at the issues with the 23 association of the quality manage.nent rule, waich one of the 24 obj ectives, how many of the obj ectivec, how rauch o' her 25 detail, and where those apply in a graded basis to the l
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various kinds of modalities and treatment.
2 Medical practice and treatment is a vast range, 3
from very, very small amounts o! material to very, very 4
large quantities of material, from unsealed materials to 5
sealed materials, and the kinds of things that are needed in 6 a variety of these areas.
7 Obviously if you are wanting to rank them by risk, 8
to be varied by those areas, right now these are a single 9
place in the regulation and sit there without a whole lot of 10 variation on the theme.
11 The issues associated with what kind of events to 12 capture, precursor events and other activities. Our thought 13 here is really how do we get to those events which are of 14 more regulatory interest, those for which they indicate 15 concerns which re ally need to be propagated to other 16 licensees becausc they may have generic implications.
17 or iss.2es of how particular things are done or 18 otherwise.
Thir!gs that are associated with breakages, 19 failures.
20 Other sorts of things for which particular actions 21 are necessary, or which would indicate that there is a flaw 22 or otherwise within the regulatory structure, either in the 23 material that is submitted in response to the rule or in the 24 rule itself, but which have an actual influence on that, and 25 try and get a way to the extent we can to whether or not you ANN RILEY & ASSOCIATES, LTD.
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I 26 1
missed on that patient for some rather unique and singular 2
reason which doesn't have more generic ramifications by 5 3 percent or 10 percent or otherwise, particularly in 4 situations where within the medical realm there is a typical 5 range of practice within which physicians choose 6 prescriptions and treatment plans on a routine basis. If 7 you went around and sampled them, you would find that kind 8 of variation. So maybe you are off by a few percent in that 9 particular one. If there were no more specific 10 implications, you were inside that kind of typical range; 11 not at all clear why we should oe concerned with that 12 particular activity.
13 The issues of training and experience. This, I 14 think, will be one of the more difficult ones. It gets to a 15 couple of points.
16 Who do we specify requirements for? In some cases 17 the individual who has the most influence on whether or not 18 it works right is not the physician at all; it's the medical 19 physicists, the individuals who are doing the treatment
. 20 plans and otherwise. In this particular case, teletherapy, 21 brachytherapy, the higher risk modalities, the bigger doses.
22 The physicians themselves. The whole concept, as 23 on the next slide we will get to in a little bit, of the
' 24 authorized user, a concept which goes way, way, way back, 25 and which in the medical community today, while still very ANN RILEY & ASSOCIATES, LTD.
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I 27 1 much used because it has grown and everybody has sort of l
2 adapted and followed this approach, may not in all cases j 3 actually track the way medicine is done these days in terms 4 of groups of physicians, in terms of HMOs and referrals and l 5 cross-referrals and other activities; as to who that 6 particular individual who ends up being the one who is 7 hooked needs to be and trying to sort that out without 8 getting in the middle of turf fights, without getting in the 9 middle of the way in which a particular medical community or 10 large institution might wish to practice the activity and 11 conduct the referrals. I 12 There are a number of issues there, particularly 1; in radionuclide therapy and in some of the things like 14 brachytherapy, high dose rate gamma stereotactic therapy, 15 which has an incredibly large number of sources and can do a 16 whole lot of damage if you miss and for which the physician 17 simply says "I want it there" and for which a team of 18 individuals goes in then implements that process.
19 Capturing emerging technologies. This is one of 20 the places where the technology changes faster than they 21 have annual meetings to go see what the new stuff is. You 22 walk around the floor, as I did, down in San Antonio and 23 you'd just be amazed at the kinds of innovations and changes 24 and new things that they are popping out on the floor every 25 few months in terms of equipment and modalities and ANN RILEY & ASSOCIATES, LTD.
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t i
28 l 1 activities. It's going to be a thing which constantly is -
2 changing, constantly is modifying and otherwise. .
~
3- How to best capture that, how to best structure
.4 the organization, which we believe is by more or less 5 all-inclusive modality blocks so that you can go in and add .
6 or modify one without affecting all the others or having to 7 consider quite so much those ramifications. l 8 In some cases we may know that there is something 9 coming. We may not be smart enough right now to know li 10 exactly what. Monoclonal antibody therapy is still very 11 much in a research developmental stage. It may look a lot i 12 like radionuclide therapy. Then again it may not in certain ,
i 13 contexts that might be important from a regulatory i
14 standpoint.
f 15 Accreditation process. As I mentioned a little 16 bit earlier, there are a number of things which happen on !
17 the medical community side of the house irrespective of NRC 18 or irrespective of use of radioactive materials in terms of ,
i 19 accreditation of hospitals, in terms of accreditation of 20 programs and systems and other activities. What we very l i
21 much want to do is to look at some of those and see if there l
22 are things which we can piggyback and use, reference or 23 otherwise.
24 As you had requested in one of the specific line l
25 items in the SRM, to look at that. We view those processes
'I ANN RILEY & ASSOCIATES, LTD. ,
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29 1 as being within the scope of industry codes and standards in 2 terms of things which may be useful to us.
l Some of them may 3 not be, and we will just have to see where they are. And it 4 may be very variable. There may be some in some modalities ,
5 which are usable and not in other modalities. I would 1
l 6 anticipate at this point a great range within what we have 7 available that we can actually use.
8 We can go ahead to the next slide.
9 [ Slide.]
10 DR. COOL: As we have been going through this and 11 applying a lot of thinking to it already, we keep coming 12 back to what does someone mean when they toss out, sometimes 13 rather glibly, that little phrase, "well, medical judgment" 14 in this particular area.
l 15 As I start to look at the questions of what do you I 16 need to report and what is an event and what are the 17 experience requirements you have to do, and what constitutes l 18 a prescription, and all those sorts of things, all of those j 19 evolve back to somewhat of a root of what exactly is the 20 purview -- this has always been a line that we have had to i
21 deal with -- of the medical judgment, which is the right and l 22 direction of the physician in dealing with that particular 23 patient, versus the point at which it moves over into a !
24 protection standpoint and those activities and how that 25 evolves in the process. I
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30 1 The sophistication of the practice. As I 2 mentioned a little bit earlier, we have a huge range both in 3 terms'of the isotopes and risks and in terms of the sizes of i
You have private 4 the institutions that are out there.
5 practice clinics. They do rather limited things. They will 6 -do some scans. They are a small group; limited resources, 7 limited activities.
8 You have on the other end of the spectrum the l J
9 huge, broad-scoped medical research, treatment and .
I 10 everything else you can think of program who have got lots l 11 and lots of resources, lots and lots of grants and l 12 activities; a variety of things that they have the ability l 13 to do simply because of the size and structure which they l 14 have.
15 How again to construct a set of requirements which 16 is sufficiently robust that the smaller organizations for 17 which the phrase "tell me what the number is and how to do ,
i 18 it and I'll go do it" may well apply versus the large j 19 organizations who really don't want to be told how to do it -
20 because they have a variety of things and under certain {
21 circumstances they may want to be doing something slightly ;
22 different because they know a lot about it; they are in a l 23 research kind of mode; they are working with FDA or i
24 otherwise, and they have a variety of activities. So trying l 25 to deal with that span which is not too restrictive or too l r
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loose on the ends of the spectrum.
2 What ]
I have nic'cnamed on this chart the " bad 3
apple" factor for lack of a better way to reference it. How 4
do we deal specifically with the enforcement activities with 5
the relatively small percentage of folks who, for whatever 6
reason, are not in compliance, don't want to be in 7
compliance or otherwise with the requirements in dealing 8 with specific issues?
9 The more you move to a performance orientation the 10 more difficult in one sense it becomes to be able to take a 11 specific, very simple citation "you did X and Y improperly.
12 Bang! Here's your citation.
You did it wrong." Everybody 13 says, " yeah, I agree.
X and Y are very clearly written as X 14 and Y."
15 There are some tradeoffs back and forth between 16 those sorts of things. The medical community continues to 17 struggle with this on its own in terms of malpractice and 18 other activities, and self-regulation; what constitutes 19 acceptable standards of performance and care.
20 It's not one which is or can be divorced f 21
\ completely from some of the other ongoing activities which 22 are going on in this community. This community is more 23 unique and more diversified than a lot of the other kinds of 24 licensees that we need to deal with. Once again, these are 25 the only folks around for whom we give them a license to ANN RILEY & ASSOCIATES, LTD.
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f
- i 32
- r 1 specifically put radiation and radioactive materials and 2 people in the same' spot. Everybody else it's much simpler. !
3 The concept of keeping'the two apart makes it a whole lot t 4 simpler trying to write.up the requirements.
5 The last one on this chart I have already talked ,
6- about in terms of the authorizec user and the potential I 7 impacts for that and how the regulation is written.
CHAIRMAN JACKSON: I don't know what would help 8
9 deal with it. It would be dependent on who your consultants 1 10 are, et cetera, but it strikes me that an issue here or a 11 hidden issue or an overarching one is the one that relates' 12 to the changes in the practice.of medicine with the ,
13 formation of HMOs and other kinds of structures, which, as !
14 you went through this list of issues, I can see affecting or !
15 being affected by any number if not all of these. I would l 16 just urge you to ensure that, if you haven't already, you ,
17 fold into your thinking the effect, and ensure that you get [
l l
18 some input, whether it's in the form of a consultant or on !
?
19 your steering committee or whatever; that you get some input 1
20 along that line. Otherwise, you could end up with a rule t 21 that is meant to address some longstanding issues that is "2
, outdated the day it hits the street.
23 MR. COOL: I agree with you. -That's part of the p 24 reason as consultants we are trying to look at folks who are r 25 practicing out there in the community. I'll be very frank I ANN RILEY & ASSOCIATES, LTD.
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t 33 1 with you.
The key source of people that we are in hopes to 2
use is to probably try and provide modifications to existing 3
contracts with the individuals who already are under 4 contract to the Commission to look at misadministration 5 events.
A number of those are individuals who are also on 6 the ACMUI. One of the things on ACMUI is in fact an 7
individual who is a hospital administrator.
8 CRAIRMAN JACKSON: A hospital administrator in the 9
traditional sense is a very different individual than those 10 who are running medical businesses. So I'll be very honest 11 with you and say that you need to extend beyond your 12 existing source of contractors so that you get the right 13 kind of perspective and information that you need. There is 14 no point in our going through this effort and, as I say, 15 ending up with a rule that is outdated the day it hits the 16 streets.
17 MR. COOL: I agree.
18 We can go ahead and go to the next slide.
19
[ Slide.]
20 DR. COOL:
The organizational outline that we have 21 been looking at and that we have tossed onto the table 22 already as a pencil idea, and which when we get to the next 23 slide I will say has been received quite favorably thus 'ar, 24 is a modality approach.
25 I want to start by saying that a modality approach ANN RILEY & ASSOCIATES, LTD.
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34 1 is not new. There have been groups going way, way, way, 2 way, way back in the medical field. Some of.those may no 3 longer correspond to actual risks; some of them may be. l l
4 folded together; other ones may need to be. created.
5 The current Part 35 is to some extent modality 6 based. In you go in and look at it, you will find 100, .200, ,
7 300,'400 which deal with specific activities, but a large ,
8 part of the current Part 35 then has other things around it.
3 Those have tended to be the things that have caused us the j 9
10 aggravation, the quality management, the training and 11 experience, some of the definitions. The proposal that we ;
12 have tossed out on the table is to take all of those and f 13 make those modality-specific.
14 In essence, the organizLtion would be.something on ;
15 the order of a series of subparts such that if what you i
16 wanted to do was diagnostic imaging with unsealed materials, l 17 you could go to Subpart A and everything that you would need :
18 to have, who was going to be licensed and what kind of {
19 license or registration or otherwise, what do you need in {
20 terms of technical things, what do you need to do in terms
+
21 of surveying, in terms of access controls, what do you need [
22 in terms of training and experience, what do you need in -i 23 terms of reporting to us, what do you need in terms of i 24 events and records and everything else, it's all there in i
25 that one part.
I f:
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I 35 1 You can have a second part for maybe therapies; 2 another part for low dose rate or manual brachytherapy; i
3 another one for the high dose rate and pulse brachytherapies l l
4 where the sources are a lot larger and the equipment more 1
5 complicated; another one for teletherapy type units perhaps; 6 another one for gamma stereotactics where a whole other 7 series of complexities come in.
8 I may have left out some we have been thinking 9 through. he end up with six or seven possibilities right 10 now, trying to derive them both on the basis of the risk or 11 doses that could be derived or generated by some of those 12 practices, and at the same time keeping in mind that medical 13 practice, being what it is and that they are to some extent 14 binned with different groups performing different things, 15 that the rule or organization ought to more or less mirror 16 the kinds of things that they are doing so when they go grab 17 whatever it is, if they are in teletherapy, it's Subpart E, 18 and there it is.
19 To go along with that, what we are in hopes to do 20 under this model would be for the guidance document to match 21 that modality approach. So you grab the rule, you grab the 22 guide that goes along with that rule, and you have 23 everything that you would need and everything that the 24 license reviewers would be looking at in that particular 25 arena.
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36 1 CHAIRMAN JACKSON: Chairman McGaffigan 2 COMMISSIONER McGAFFIGAN: How do you deal with 3 emerging technologies that don't fit one of the parts? Do 4 you have a subpart called emerging technology that says that 5 this is how we do it?
C MR. PAPERIELLO: That's what we would do. We 7 would have a sort of a catchall category, and as we got 8 experience, then we would eventual'y drop another module 9 .gover that particular modality.
10 COMMISSIONER McGAFFIGAN: So you would have 11 something in there so that you wouldn't be a hinderance?
12 MR. PAPERIELLO: Obviously.
13 COMMISSIONER McGAFFIGAN: You would have a 14 place-setter, and then as it got a formal title, it would 15 get its own subpart over time. I 1
16 MR. COOL: Exactly. A set of things which would 17 in general lay out the kinds of minimum criteria for these l
18 sorts of things, which you would then look at on a l 19 license-specific basis as they started to develop that, and 20 as you develop the set of criteria and the practice itself 21 and got to the point where it was probably moving from a l
22 research developmental kind of mode into a routine use mode, 23 then you could mirror that with a new subpart.
24 This organization, quite frankly, is likely to 25 result in more words in Part 35, because there will be to a l
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1 37 1 certain extent repetitions.
2 CHAIRMAN JACKSON: You mean I am not going to be 3
able to tell the Vice President that we have eliminated so 4 many pages of regulations?
We get asked that every year.
5 MR. COOL:
That is in fact a downside, but if you 6
were a diagnostic group, you've actually eliminated a bunch 7
of pages, because they only need Subpart A. So it sort of 8
depends on how the Vice President wants to count.
9 CHAIRMAN JACKSON: I'll take you along with me.
10 MR. COOL:
I'm sure that would be a wonderful 11 discussion as well.
12 MR. PAPERIELLO:
I would make an observation. We 13 have put entirely too much prescriptive requirements in Part 14 35. Surveying once a week.
That is absolutely unnecessary 15 to be in a rule. On the other hand, surveying a patient 16 after brachytherapy before you release them, I probably 17 would leave that prescriptive requirement in the rule 18 because it's a simple thing, and if you do it, you can 19 prevent one hell of a lot of damage. How many times you 20 survey your laboratory -- I don' t know. Tell me how much 21 you do in a laboratory.
22 COMMISSIONER McGAFFIGAN: It sounds like they have 23 an outline at least for their rule.
24 CHAIRMAN JACKSON:
It's well hidden to this point.
25 COMMISSIONER McGAFFIGAN: So the pencils can start ANN RILEY & ASSOCIATES, LTD.
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38 ;
1 working. ;
CHAIRMAN JACKSON: All right. Let him show his 2'
3 last viewgraph.
4 MR. COOL: If I can have the next slide, please.
5 [ Slide.]' ,
6 DR. COOL: We have already had several interactions, some of which you are very.much aware of. In 7
8 terms of the ACMUI meeting back in April, they presented 9 their views to you in a meeting a little over a month ago.
l 10 We went out and had discussion at the Conference 11 of Radiation Control Program Directors meeting. That was in i 12 late May. We presented them with the ideas and thoughts, i 13 presented them with this modality approach as an idea; !
t 14 tossed some rocks at it, and very much encouraged them as we l 15 did in each of these cases that we need to get down to the I 16 real words, the real language. That was echoed by a number.
17 of the individuals in-the meeting on the need to provide _[
p 18 specific, explicit language.
19 In this first round of. meetings, not" surprisingly, f 20 they sort of got it tossed at them for the first. time:
21 okay, the process that they have been talking about and we l 22 have been talking about, and we're waiting. Well, okay, now 23 it's go.
24 Didn't get a whole lot of "30.32 really should be [
25 written this way at this point," but I believe a number of [
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folks went away from that with the idea that they were going 1 2
to go back and start to look at their particulars.
3 Interacted specifically with the people who have been 4
nominated to work with us on that working group. Very much 5
interested in talking in terms of schedules and ideas and 6
when things would be coming up, some of the ideas which they 7 had going on.
8 A week ago, down in San Antonio the Society of 9
Nuclear Medicine had their annual meeting. They carved a 10 two-hour block out in the middle of their schedule for us to 11 come down and talk. Presented again the same sorts of 12 views. Had it on the table.
13 Most of the feedback during that actual meeting, 14 not surprisingly, dealt with process rather than individual 15 details of the rule language. The process that was being 16 pushed for by individuals in the audience was a much more 17 participative process than the staff proposal.
18 I can summarize it in two words. It looked for 19 all the world like negotiated rulemaking. The comments were 20 almost universally along the linec of we want to be in the 21 beginning, we want to be writing with you. At one point we 22 wanted to have an equal vote and sit around the table so NRC 23 doesn't have an overriding vote. Some of those sorts of 24 things.
25 Separately while I was in San Antonio I met with ANN RILEY & ASSOCIATES, LTD.
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40 1 the leadership of the group, who expressed perhaps a 2 slightly more moderate view. Again, very interested in ,
3 participating and writing. They indicated they would come 4 in and talk to several of you. I'll take it at face value 5 that they did so, and your views of what happened during 6 that interchange are probably different f rom their viev's of 7 what happened in that interchange.
8 They were very supportive of having a chance to 9 write early and told me that they were going to go start 10 trying to write down specific pieces, Society of Nuclear 11 Medicine being particularly interested in the unsealed area 12 and in the diagnostic arena, which is an area where likely 13 there are going to be significant changes because that's an 14 area which we can probably walk away from a lot of the stuff 15 that is there now.
16 I believe that they are in a position, after 17 having talked with their leadership, to get us specifics in 18 language. They are very interested in that process. They 19 are also very interested in participating around the table 20 to hammer out the details of the work.
l 21 This week, in Tahoe, the American College of l
22 Medical Physicists annual meeting. These are the folks who 23 are on the line dealing with higher risk activities, 24 translating prescriptions into treatment plans, teletherapy, 25 brachytherapy, and otherwise. These are the higher risk l
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r 41
~
1 folks.
Again, very, very interested in the process, very, 2
very much wanting to be participating, and indicating to us 3 that they will have us written stuff within the next month, 4
and wanting to be very heavily involved in the process.
5 So the feedback at the first level has been more 6 related to process. We've seen a great level of interest 7 out there. Have a number of at least verbal commitments 8
that written materials and details would be forthcoming, 9 which can only be judged as we get down the line and see to 10 what extent we actually get that.
11 Sort of the two ends of the spectrum, the unsealed 12 materials and the lower risk materials, very much 13 interested, and the medical physicists and the higher risk 1 l
14 arena, also in the same sort of position. That's in general 15 the kind of feedback that we have gotten to date, which has 16 been generally appreciative.
17 CHAIRMAN JACKSON: Commissioner McGaffigan.
18 COMMISSIONER McGAFFIGAN: He essentially answered l 19 it in the second part, which is within a month, which you !
l 20 said for the second group, that you will be getting some I 21 wordF. The first group, they have a chance to write early; 22 they are anxious. To some degree these folks have had many 23 years to write. If they will get something in, it would be 24 useful. Do you have a sense it will be soon?
25 MR. COOL: We didn't talk days. They were ANN RILEY & ASSOCIATES, LTD.
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42 1 indicating that someone of the government relations group 2 would probably oe here in the audience. Our expectation is 3 we will get back to them with more specifics as soon as we 4 knew it. The impression, because we did not talk days and 5 schedule because I couldn't talk days and schedule, was that 6 they wanted to participate, and if that meant that they 7 needed to move quickly, that at least the leadership was 8 prepared to do so. ,
9 CHAIRMAN JACKSON: Let's see your backup slides.
10 MR. COOL: If I can have backup slide 1, 11 Alternative One.
12 (Slide.]
13 DR. COOL: Alternative to the process that we have 14 laid out is to walk away from the formal first round of r Much along the lines that you said, there are i 15- interactions.
16 a number of background documents. Go ahead and start l i
17 putting pencils and otherwise to paper.
18 These slides are not in your book. These have ;
i 19 been generated over the last couple of days. I apologize i 20 that we don't actually have paper copies for you.
21 CHAIRMAN JACKSON: Do you have at least two 22 copies? It's very difficult to see from here.
23 MR. COOL: I-don't know that we have any. Let me 24 give you mine. I think I know what I wrote.
25 To fundamentally walk away from the first formal
{
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\ -- . .-, .-
1 43 1 round of interactions. t So under this alternative, rather 2
than the notice of proposed rulemaking and solicitation of 3
early comments, begin immediately with a process of 4 drafting, of laying out alternatives. Simultaneous with ;
5 that, being receptive to and open to any input which we 6 would get from the medical community and otherwise.
7 In other words, keep moving and keep doing the 8~
sorts of interactions that we have been doing with medical' 9
community, encouraging them to get things in early. This 10 would up the time frame, because the drafting would be very 11 much more running on a shorter fuse.
12 The object of this would be to have some drafts 13 which could be discussed with some options by the time 14 certainly that we got to the Agreement State meeting in 15 October; 16' To start interacting with the ACMUI early this 17 fall; 18 To move from there to the facilitated public 19- meetings, which were viewed in terms of bang for the buck, I 20 if you will -- several of you have already indicated this -- l 21 where there are things on the table much more likely to get l
22 very specific section, paragraph, line, chapter, verse i 1
23 changes and additions and otherwise, such that a proposed 24 rule which would include those interactions could come to i 25 the Commission in May of next year, and then enter into the ANN RILEY & ASSOCIATES, LTD. ,
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i 44 1~
more normal, traditional proposed rule and comment process.
2 You could still very well hold a couple of meetings during the formal proposed rule period. Those have 3 ;
4 not been specifically marked on the chart. That would not l 5 directly impact the schedule if you wanted to hold a meeting I
6 or two during the formal 90-day public comment period. That public' comment period was set at 90 days. That is the' ,
7 From there, 8 minimum under the Administrative Procedure Act.
9 to move into the development of the final rule with all the }
10 associated documents and all of the guidance documents that 11 have been laid out.
12 MS. CYR: Ninety days is not the minimum. )
13 Seventy-five is the minimum under the NAFTA.
14 MR. COOL: Thank you. I can take 15 off. Thank .
15 you very much.
l 16 MR. THOMPSON: We do take our advice from counsel.
17 CHAIRMAN JACKSON: Take 15 days off the schedule. ,
-i 18 COMMISSIONER DIAZ: Shouldn't the informal public !
19 interaction finish before you develop a rule maybe to set ,
20 some urgency to people to get it before you actually get to f I
21 the time line?
22 MR. COOL: That's actually the part that we are 23 walking away from, because we will be drafting, and within 24 six to eight weeks we would have the working group looking 25- at and refining ideas. Under this alternative, while we ANN RILEY & ASSOCIATES, LTD.
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1 !
. 1 t
45 !
1 t
would be open and continually open to interacting in 2
informal interactions, we would be moving forward.
3 The plan would be to have drafts publicly i j
4 i available, put them in the public document room, put them on i 5 the net. They would be more than welcome to E-mail us. t 6
To the extent that the various societies are off 7 drafting their own things and a few weeks from now would :
i 8 come in and say, here's some draft language, wonderful. !
9 !
I'll notice the meeting; we'll sit down; we'll refine it.
10 If they want to go off and refine it some more and come back '
11 and interact with us, we'll be open to all of that. But the 12 sense of urgency would be very much increased, because we i 13 would start harder development, somewhere between a pencil 14 and a pen, laying down some of the ideas so that we could 15 have a draft, or in areas like training and experience, some 16 key options laid out that we could be in a position to 17 hammer at a round-table discussion later this year. l 18 CHAIRMAN JACKSON: I was going to mention this in l
19 my closing remarks, but I actually think you need to within 1
20 the next day or two send a supplement to the Commission that i 21 lays out this expedited schedule, fleshing out some of what i 1
22 you are saying, because we are not going to sit here and I
i 23 look at this in great detail sitting here at the table. l 24- _They might.
25 COMMISSIONER McGAFFIGAN: Just to echo l
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1 w
ould be open 2
3 informal interactiand ons, continually op 45 we would be en to interacting i n 4 The plan w 5
available, put ould be to hav moving forward.
the net. them in the publi e drafts publicly 6 They w ould be 7 To the more thanc document e
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, put them on extent that 8
drafting their the w lcome to E-mail us.
come in own things various and a few societies 9 and say, here's are off weeks from now w 10 I'll notice the ould 11 If they want to go meeting; w 'll sit dsome draft languag e ,
wonderful.
and e 12 interact with s,u off and refinesome it own; w 'll refine t.
i sense 13 of urgency w we 'll be open to more ould be and come back all of that.
14 would start harder very d much increased, But the 15 and a pen, laying d evelopment, somewher because we have own e betw 16 a draft, some of een a ps.acil
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17 key options laid eas like training a o that we could
\
out hammer at a that we 18 19 round-tables discus aicould position tobe some in nd experienc CHAIRMAN my closing remarks JACKSON: on later this year 20 I was going to the lays next day or otw , but I actually think 21 out send a you mention this in 22 this supplement need to you are expedited schedule within 23 look at saying, becausewe
, to the Commissio n that are fleshing out some 24 this in great d They might.
not going to of what 25 etail sitting her sit here and e at COMMISSIONER the table.
McGAFFIGAN: Just to echo ANN RILEY 1250 I Str Cour& ASSOCIATES, t Reporters LTD.
Washin eet, N.W gor 7. , Su V p
!- l 47 l
^
! 1 rule. It-has to be a logical outgrowth of what you propose, l i
l 2 but you can develop a final rule which could look 3 subr'cantially different from what you have proposed.
l 4 CHAIRMAN JACKSON: I think that your caveat is f i
l 5 good, Karen. I think we can't ourselves get locked into the ;
l 6 idea that sending out the proposed rule means that it's !
7 somehow cast in concrete. That's where the inherent f
8 flexibility lies, but it also addresses the issue of putting f
- 9 some initial flesh on the bones in a more refined way. i 10 Commissioner Rogers. i 11 COMMISSIONER ROGERS
- Just a couple of i
12 observations. It does seem to me that one has to be a
! 13 little careful here in developing a program by analogy to l l !
14 the decommissioning rule effort, which really had quite a l l 15 different kind of impact on the general public. It seemed 16 to me there we had to deal with a broad collection of public 17 interest groups rather than professional interest groups.
18 When we talk here about public input, we are probably 19 talking about the' input f_om the professional groups.
20 MR. COOL: That's correct.
21 COMMISSIONER ROGERS: I think you've had a lot of 22 trouble trying to get what you might really call Mr. John Q l
l 23 or Mrs. John Q Public to get any interest in this thing at 24 all. We have really fallen very flat on that and almost 25 given up on it.
L
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48 1 In a certain sense the technical term of public 2 interaction may be correct, but it really isn't broad; it's 3 really the collection of professional interest groups that 4 have to be involved here rather than some broad public.
5 We've heard a lot from them. I'm not going to repeat 6 everything that is said. So it does seem to me that the 7 character of this enhanced participatory rulemaking-should 8 be very, very different here from what we were talking about 9 in the decommissioning because the purpose is quite 10 different.
11 As I, listen to it, I don't really quite see why 12 this facilitated public interaction, which is really with 13 these professional groups, can't move earlier on your chart 14 here. That's where the carpentry is to be done; that's 15 where people have to really hammer things out. A mixed 16 metaphor.
17 At any rate, I think that maybe we are all 18 uncomfortable here, and I'm a bit uncomfortable. Even this 19 new chart seems to me to give perhaps too much time to the 20 so-called informal, because I guess we really don't know 21 what informal means.
22 Facilitated, I know what that means. You've got a 23 facilitator and you try to drive towards some kind of 24 commonality. It does seem to me that there are real 25 benefits to having a facilitated approach because of the ANN RILEY & ASSOCIATES, LTD.
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45 1 would be open and continually open to interacting in 2 informal interactions, we would be moving forward.
3 The plan would be to have drafts publicly 4 available, put them in the public document room, put them on 5 the net. They would be more than welcome to E-mail us.
6 To the extent that the various societies are off 7 drafting their own things and a few weeks from now would 8 come in and say, here's some draft language, wonderful.
9 I'll notice the meeting; we'll sit down; we'll refine it.
10 If they want to go off and refine it some more and come back 11 and interact with us, we'll be open to all of that. But the 12 sense of urgency would be very much increased, because we 13 would start harder development, somewhere between a pencil 14 and a pen, laying down some of the ideas so that we could 15 have a draft, or in areas like training and experience, some 16 key options laid out that we could be in a position to 17 hammer at a round-table discussion later this year.
18 CHAIRMAN JACKSON: I was going to mention this in 19 my closing remarks, but I actually think you need to within 20 the next day or two send a supplement to the Commission that 21 lays out this expedited schedule, fleshing out some of what 22 you are saying, because we are not going to sit here and 23 look at this in great detail sitting here at the table.
24 They might.
25 COMMISSIONER McGAFFIGAN: Just to echo ANN RILEY & ASSOCIATES, LTD.
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.= - -. . .
4 46 1 Commissioner Diaz' point, clearly the message should go out 2 to the professional societies and the public getting 3 something to you early is better than getting '"nething to 4 you or May 31, 1998, the last date under thir posal the 5 informal public interaction will end, and you'll give us a 6 SECY paper the next day for us to think about it, if I am 7 reading this right. So the earlier the better on the public 8 comment. As in any process, getting your thoughts down on i 9 paper earlier has a bigger influence.
10 MR. COOL: That's correct.
I 11 MS. CYR: The Commission ought not to lose sight 12 of the fact that a proposed rule is in fact supposed to be 13 -- too often in this agency we think that when we go out 14 with a proposed rule stage that we have somehow written in 15 stone at that point, and we ought not to convey that 16 impression.
17 CHAIRMAN JACKSON: Exactly right.
18 MS. CYR: Yes, we are going to have this early 19 interaction, but it seems to me that the proposed rule is 20 only that.
21 CHAIRMAN JACKSON: Exactly right.
22 MS. CYR: You are certainly looking for public 23 comment and expecting to make changes in response to that.
24 You have a whole period under this schedule for another year !
25 and a half in which you are going to be developing a final i
I ANN RILEY & ASSOCIATES, LTD.
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I l- :
47 l 1 rule. It.has to be a logical outgrowth of what you propose, 2 - but you can develop a final rule which could look i
3 substantially different from what you have proposed. j i
4 CHAIRMAN JACKSON: I think that your caveat is !
5 good, Karen. I think we can't ourselves get locked into the !
6 idea that sending out the proposed rule means that it's 7' somehow cast in concrete. That's where the inherent l
8 flexibility lies, but it also. addresses the issue of putting
, 9 come initial flesh on the bones in a more refined way, t
10 Commissioner Rogers.
11 COMMISSIONER ROGERS: Just a couple of 12 observations. It does seem to me that one has to be a
( 13 little careful here in developing a program by analogy to i
l 14 the decommissioning rule effort, which really had quite a 15 different kind of impact on the general public. It seemed 16' to me there we had to deal with a broad collection of public 1
17 interest groups rather than professional interest groups.
18 When we talk here about public input, we are probably 19 talking about the input from the professional groups.
20 MR. COOL: That's correct.
21 COMMISSIONER ROGERS: I think you've had a lot of 22 trouble trying to get what you might really call Mr. John Q 23 or Mrs. John Q Public to get any interest in this thing at 24 all. We have really fallen very flat'on that and almost 25 given up on it.
i i
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48 ,
1 In a certain sense the technical term of public 2 interaction may be correct, but it really isn't broad; it's 3 really the collection of professional interest groups that 4 have to be involved here rather than some broad public. '
5 We've heard a lot from them. I'm not going to repeat 6 everything that is said. So it does seem to me that the 7 character of this enhanced participatory rulemaking should !
8 be very, very different here from what we were talking about 9 in the decommissioning because the purpose is quite 10 different.
11 As I, listen to it, I don't really quite see why ,
12 this facilitated public interaction, which is really with 13 these professional groups, can't move earlier on your chart i
14 here. That's where the carpentry is to be done; that's 15 where people have to really hammer things out. A mixed '
16 metaphor. .
17 At any rate, I think that maybe we are all 18 uncomfortable here, and I'm a bit uncomfortable. Even this 19 new chart seems to me to give perhaps too much time to the 1
20 so-called informal, because I guess we really don't know ]
21 what in: formal means.
22 Facilitated, I know what that means. You've got a 23 facilitator and you try to drive towards some kind of 24 commonality. It does seem to me that there are real 25 benefits to having a facilitated approach because of the 1
I l
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49 1
past complaints that the NRC stuffs e'rerything down people's 2 throat s . If you have got a facilitated meeting that 3
actually does come to pretty good common ground, I think 4
that will tend to diminish the credibility of that kind of 5 an argument. The informal one, I don't know what is going 6 to come of that.
7
, All I am saying is I think that I would like to 8
see you try to move as quickly out of the informal into the 9
facilitated and use the facilitated efforts to really come 10 to grips with what these things ought to say and get 11 everybody together in one room and argue it out, and use a 4
12 facilitator, though, so that there is no complaint that NRC 13 just totally dominated this when everybody else had a 14 different view. Ultimately NRC has the authority and has 15 the responsibility. There is no questien about it.
16 If everybody doesn't like it and we feel we are 17 obligated to do it under the Atomic Energy Act or something, 18 we'll do it, but we don't want to start out that way.
19 I would urge for more emphasis on the facilitated 20 interactions. If you want to lacel them public, okay, but 21 we really know that that public is the interested 22 professional society groups, not a broad public. Although 23 I'm sure they would be welcome, they're not going to come.
24 They haven't so far.
25 The other thing, on General Counsel's observation ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
50 1 about a proposed rule is just a proposed rule. I'm not a 2 lawyer. I'm not going to argue with the general counsel, 3 but I think the history has been that we haven't made very 4 big changes from proposed rules in general. We can.
MS. CYR: That was exactly my point. That has 5
6 been our practice, but that's not what the legal framework 7 is.
8 COMMISSIONER ROGERS: I understand.
9 CHAIRMAN JACKSON: New opportunity.
10 COMMISSIONER ROGERS: It's a new opportunity, but 11 you have to demonstrate the credibility of that observation, 12 because we have said that many, many times in the past, and 13 the net result hasn't been very different.
14 CHAIRMAN JACKSON: That's an opportunity for all 15 of us. When we send out the proposed rule and there are 16 substantial comments and concerns, then we have to 17 accommodate it.
18 COMMISSIONER ROGERS: My point is that facilitated 19 interactions provide an opportunity to kind of diminish the 20 concerns.
21 CHAIRMAN JACKSON: I'm going to keep going down 22 the line with the Commissioners so we can get the final 23 questions or comments in. But let me ask you this. Can you 24 give us the resource loading for the new schedule? You can
, 25 send it as the supplement.
1 i
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1 51 MR. PAPERIELLO: It was in the budget, We gave it 2
to the budget review group. We just transcribed the 3 numbers.
4 CHAIRMAN JACKSON:
5 All you have to do is lift it out and put it in.
6 Commissioner Dicus.
7 COMMISSIONER DICUS:
On these alternative 8 schedules, 9
I think we have focused on alternative one. I was looking over here at alternative two as well .
10 CHAIRMAN JACKSON:
Alternative two?
11 COMMISSIONER nICUS: Yes.
12 On alternative two you have in the fourth quarter 13 of the fiscal year public input, 14 but there is no mention here of facilitated public interactions.
15 that, Are you planning or are you going to come back in the supplemental 16 paper and explain these two alternatives?
17 MR. THOMPSON:
18 I think we need to do that. We haven't 19 had a full chance for Carl and I to look at that.
This was something we developed in recognition that we 20 21 needed to have an alternative approach in general concept ,
and we need to flesh this out a bit more.
22 COMMISSIONER DICUS:
23 I think having the public input early is addressing Commissioner Roger's concern 24 .
CHAIRMAN JACKSON:
25 this paper? What is the current due date on ANN RILEY & ASSOCIATES, LTD.
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52 1 MR. HOYLE: I don't have that with me.
Let us agree, since we do it as 2 CHAIRMAN JACKSON:
3 a public vote, that we want this supplement with these and we l
4 things fleshed out. We'll give you one extra week, 5
will extend the due date on the vote on the paper for one f
1 6 extra week, Can we all agree on that?
? MR. HOYLE: June 20 was the due date.
So June 27, but with the 8 CHAIRMAN JACKSON:
will come.
9 understanding that within the week the supplement COMMISSIONER DICUS.
A couple other points. I 10 I was equally 11 want to be sure to make it unanimous that 12 concerned with the time line that we saw in the original that you were able to do a 13 paper and appreciate the fact 14 quick recovery and try to shorten this at least to the time 15 that we wanted as we put it out in the DSI.
16 A couple of quick comments, probably preaching to 17 the choir, and I hope I am preaching to the choir here.
18 A couple things to keep in mind as you go forward with this process.
I mentiened the radio pharmacies. I 19 20 think you are already aware of this, but when we revise Part 21 35 there are other parts of our regulations that could be 22 impacted. This happened to us in Part 20, and we didn't And also with the reg guides. So you 23 catch all of those.
24 have got to think outside the box on this.
25 7'11 give you one particular, and it's Part 32 ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
53 4
1 with the licensing of radio pharmacies. You've got to be 2 sure that as we revise 35 we look at 32 as well, particular 5
3 the reg guides. I think you already know there is a 1
4 conflict there with the reg guide. I think we are going to 1
3 5 have to watch this as we go forward.
6 The second comment I would like to make is I think
. 7 the people you will be dealing with, particularly the 8 professional societies, the other stakeholders and the a
9 states, and non-Agreement States as well, will help with j 10 this, but we always have to remember that the NRC does, 11 after all, regulate only a partial segment of the use of l 12 radioactive materials in medicine, and certainly only a very i I
13 small part of the use of radiation in medicine. I j 14 Whatever happens with 35 has got to be done l l
15 thinking in the context of how does this impact the use of 16 an x-ray machine. Even though we don't do that, we cacnot l i
l 17 do this without keeping those sorts of things clearly it 4
18 mind.
19 CHAIRMAN JACKSON: Commissioner Dias.
{ 20 COMMISSIONER DIAZ: First, I want to thank
\
21 Dr. Cool for a wonderful presentation without the aid of I
22 viewgraphs.
23 MR. COOL: Thank you.
24 COMMISSIONER DIAZ: That was very good.
25 I think we have said everything. I think time is l
i ANN RILEY & ASSOCIATES, LTD. I Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
54 1 the important thing. I just wanted to bring up a side 2 argument following Commissioner Dicus' comments. I haven't 3 seen anything in writing and I know it doesn't pertain to 4 Part 35, but in all of these conversations and meetings has 5 the issue of accelerators been brought out, and if so, could 6 we get a separate report on some of the staff thinking and 7 the information that is being received from the community on 8 the separate issue of accelerators?
9 CHAIRMAN JACKSON: We should fold it in, but not 10 as parc of this particular one.
11 COMMISSIONER DIAZ: Not as part of this.
12 MR. COOL: To date the feedback has only been in 13 terms of questions with regard to why the SRM was written 14 the way it was and the questions about why the IOM report 15 was not accepted.
16 COMMISSIONER DIAZ: I see.
17 MR. COOL: Beyond that, we really haven't gotten 18 any substantial feedback that I could summarize and report 19 to you. They asked a couple questions. I in fact chose to 20 respond to them by reading the specifics of the SRM. They 21 went on to another question, and that was as far as the 22 Society of Nuclear Medicine. There might have been slightly 23 more colorful language.
24 CHAIRMAN JACKSON: Get out of Dodge.
25 Commissioner McGaffigan.
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55 1
COMMISSIONER McGAFFIGAN: On the resource issue, 2
one of the things I noticed in the paper is most of the FTEs 3
and resources are in NMSS, but in FY-98 and FY-99 we still 4
have Resea: ch doing a significant chunk of rulemaking with 5 1.9 and 1 FTE. I don't want to open up the whole discussion 6
of the direction we gave separately about getting rulemaking 7
activities back into the program offices, but does this 8
reflect the current status quo, and as modulo are those 9
people getting transferred into NMSS at some point, and 10 those resources getting transferred in?
11 MR. COOL:
It basically does in the sense I have 12 met with the division in Research. We have reached an 13 agreement with regard to their providing an individual.
14 They're part of the team working on it. This is 15 irrespective of any of the other possible changes. Our 16 intention is to use some of the contract vehicles; the 17 Internet capability that has already been developed in terms 18 of posting things. Some of that support, because the 19 infrastructure sits there, it only makes sense to try and 20 tap it.
21 CHAIRMAN JACKSON:
But you can't presuppose it, 22 23 because we haven't made that formal decision about where the rulemaking gets done.
24 COMMISSIONER McGAFFIGAN:
25 We've made the decision in principle in the SRM and the DSI to take rulemaking out JJRJ RILEY & ASSOCIATES, LTD.
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56 1
of Research, but the details the staff hasn't proposed to us 2 yet.
MR. THOMPSON:
We have not, and this really 3
4 reflects the current organizational structure and 5 responsibilities.
The second point. I 6 COMMISSIONER McGAFFIGAN:
7 think I agree with Commissioner Rogers about the facilitated 8 only because I think it will ge3 the pencil working faster.
say, 9
It sounds like to go into a facilitated discussion on, it.
10 section 30.32, you have to have something to say about 11 It's really the same comment, but I think if the facilitated 12 discussions occurred earlier, it might force pen to paper 13 both here and in the community earlier.
CHAIRMAN JACKSON:
By the way, I would like to 14 We have to be careful if 15 kind of make an addendum to this.
I know this is just for 16 we keep talking about blank sheets.
You 17 purposes of discussion. You want to rewrite Part 35.
18 are not necessarily looking section by section at the 19 existing Part 35 and saying "I want to change it."
20 COMMISSIONER McGAFFIGAN: That's what I said 21 earlier. I think they've got a new outline.
CHAIRMAN JACKSON:
You basically have to write a 22 23 new Part 35.
COMMISSIONER McGAFFIGAN:
They have a new outline; 24 of it is going to 25 they know what they want to fill in; a lot ANN RILEY & ASSOCIATES, LTD. f Court Reporters 12 50 I St '. eet , N.W., Suite 300 Wast 7 ton, D.C. 20005
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57
, 1 come from the current Part 35.
2 CHAIRMAN JACKSON: I agree, but not to do it 3 necessarily as a section by section, line in, line out kind 4 of thing.
5 MR. PAPERIELLO: The other thing is we need to 6 develop the licensing guides to go with it. Frankly, there 7
are a lot of areas of Icw risk that I intend that we are 8 going to reduce the effort both on our part and the 9 licensees. Diagnostic nuclear medicine, and I define that 10 as less than 5 REM TEDE --
11 CHAIRMAN JACKSON: You don't have to tell us the 12 rule today.
13 MR. PAPERIELLO: I want to make sure we don't add 14 requirc.nents through the licensing back door that we take 15 out of the regulations. That has happened in the past.
16 I also want a very honest game. For four years 17 the staff has been accused of lying to the Commission, being i
18 stupid and incompetent.
19 CHAIRMAN JACKSON: Not this Commission. l 20 MR. PAPERIELLO: I wanted to build a record to 21 show when we have the final rule we did an honest job and l 22 the like.
I 23 CHAIRMAN JACKSON: We think you are honest in the l
24 absence of evidence to the contrary.
l l 25 [ Laughter.]
l i
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58 1 COMMISSIONER ROGERS: And not stupid.
2 CHAIRMAN JACKSON: In the absence of evidence to 3 the contrary.
4 MR. THOMPSON: But there are those out there who 5 would'like to paint the staff in that role.
6 CHAIRMAN JACKSON: Let me make sure you understand 7 this. You've gotten various-individual and collective 8 inputs today. I don't believe there is an-adversarial issue 9 between this Commission and the staff. So let the record 10 show this. I think we'are just trying to move this process 11 along.
12 I would like to thank you for today's briefing.
13 The discussion we have had of the logistics issues 14 associated with your proposed program for revision of Part 15 35 as well as feedback that you have gotten from recent 16 meetings with professional organizations will assist the 17 Commission in its review of the SECY paper.
18 There is a lot of work to be done on the istuas 19 presented today within the new proposed time line that is 20 now consistent with the time line of the SRM. There are 21 going to be a lot of long hours spent on these issues and 22 getting the rule done, but in the long run I'm sure we all 23 realize the benefits of taking an honest and, the operative 24 word is, " fresh look" at what are undoubtedly controversial 25 issues.
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t l N 59 t .
l 1 So I. anticipate that with the information provided 2 today the Commission is going to vote on this paper modulo
- 3 the revised schedule in the very near future, but I think ,
! t 4 you've heard enough to know of the need to provide a 5 framework for public input and decision-making, folding in i l
6 what you have already learned over the years from 7 interactions with the medical community and other 8 stakeholders.
l 9 I reemphasize the need to get input from 10 individuals who.can give you current views relative to the j j 11 practice of medicine so that the rule is not DOA, and then 12- you are going to provide us with the supplement on the -
j 13 amended schedule to flesh out what that all means. With ,
14 that we can take account of'all the concerns and give you j l 15 some fast feedback so you can get started on-this.
l
! 16 Thank you.
17 [Whereupon, at 10:20 a.m., the public meeting was l 18 concluded.)
i .19 20 l
l 21 l
22 23 24 25
]
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_ _ . ._ .m _ - _ _ _ _ - - . _ _ _ _ . . .. . _ _ . _ _ _ - , . . . _ _ . . . _ . _ _ . . _ _ . _ . . . .._ _ . ._ _ _
CERTIFICATE 1 ;
This is to certify that the attached description of a meeting- !
6 i
l; of the U.S. Nuclear Regulatory Commission entitled: l l :
L i TITLE OF MEETING: BRIEFING ON MEDICAL REGULATION ISSUES l I
i l PLACE OF MEETING: Rockville, Maryland ;
i
! DATE OF MEETING: Thursday, June 13, 1997 i
was held as herein appears, is a true and accurate record of ;
the meeting, and that this is the original transcript thereof ;
I l taken stenographically by me, thereafter reduced to typewriting by me or under the direction of the court l
reporting company i !
l Transcriber: Obod k bh ,
l Reporter: Michael G. Paulus t
i 1.
f ...,,,
(.Wg),
i l
l Program to Revise /10 CFR Part 35
" Medical Uses of Byproduct Material" Donald A. Cool, Director t Division of Industrial & Medical Nuclear Safety ,
Office of Nuclear Material Safety & Safeguards June 13,1997 i
t ;
iW,)
3 TOPICS TC' BE COVERED Plan for revision to Part 35 Conceptual Ideas
. Initial Feedback from Professional Organizations
s' -'
E., 'I I
FUNDAMENTAL OPERATING PLANS i Enhanced Participatory Rulemaking
" Blank Piece of Paper" '
l
- f. .. ., ,
- . c' PROPOSED STEPS TO PLAN
- Early Input
- Validation of Rulemaking Initiatives
- Proposed Rule
- Final Rule
PROGRAM FOR REVISING 10 CFR PART 35 ASSOCIATED GUIDANCE DOCUMENTS, AND -
1979 MEDICAL POLICY STATEMENT PUBLIC INPUT Staff Development of Documents Commission Review and Approval
p sn a 88 ce,,
($)
PROJECT ORGANIZATION
- Steering Group
- Working Group
- Consultanis/ACMUI l
t
- l
(.$$)
SOURCES OF DATA NRC International Organizations
. Professional Societies
,&# 'I G Dg ;
@~. 61 ISSUES SUBSUMED j
. Indiana Pennsylvania j Incident Investigation Team
. Open Rulemakings
- Medical Issue Papers
- Internal Staff Audits I J
7
- f. .. .,. . .
N),.
ISSUES QM Requirements Misadministration vs. Medical Event
. Training and Experience
. Capturing Emerging Technologies
. Accreditation Process
gSR AIG eg i
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. %~.5:.f/!
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Issues { Cont.}
s i
- Medical Judgment '
l L - Sophistication of Practice j
- " Bad Apple" Factor
- Authorized User l i
j
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hY...$.) ;
Modality Approach Who Licensed
! - Technical Issues (e.g., surveys, ;
access controls) !
- Training and Experience
- Licensee Event Reports (Misadministrations, etc.}
- . Records
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1 Meetings to Date ACMUI CRCPD SNM/ACNP ACMP il
>j
. . .- .. . . .- ..