Text

Transcript of 980819 Public Meeting in San Francisco,Ca Re Proposed Rev of 10CFR35 & NRC Medical Policy Statement. Pp 1-238.With Certificate
	ML20154A174
Person / Time
Issue date:	08/19/1998
From:	; NRC
To:	;
References
	FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 ASB-300-410, NUDOCS 9810020219
	Download: ML20154A174 (240)
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1 !

1 UNITED STATES OF AMERICA -I 2

. NUCLEAR REGULATORY COMMISSION O/ 3 4 ***

5 PUBLIC MEETING:

l 4

6 PROPOSED REVISIOF ON PART 35'AND THE

.7 NRC'S MEDICAL .'OLICY STATEMENT 8

9 Ana Hotel i

10 50 Third Street 11 San Francisco, California

~

12 13 Wednesday, August 19, 1998 '

.14-15 The public meetine, commenced, pursuant to notice, 16 at 9:04 a.m.

17 18 PARTICIPANTS:

19 FRANCIS CAMERON, Facilitator 20 ROBERT J. LULL, M.D.

21 RICHARD HEUSER, M.D. FACC 22 MARY PAT MANNING 1 23 CHARLIE SHOWALTER i i

24 MELISSA C. MARTIN 25 DAVID NEBLETT l

i ANN RILEY & ASSOCIATES, LTD.

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2 1 PARTICIPANTS: [ Continued]

[ 2' KATHY S. THOMAS, MHA, CNMT 3 W. A. EHMIG 4 SUSAN MCLAUGHLIN 5 DAVID BELK 6 DALE AUSTIN 7 NIKKI HOBSON

, 8 EDGAR D. BAILEY 9 TERRY FRAZEE 10 DR. DONALD A. COOL 11 CATHY HANEY 12 DIANE FLACK 13 ROY. BROWN

14 DAVIS LARSON, M.D.

I 15 JAY W. MILLSON.

16 17 18 19 20 !

21 l

22 23 '

24

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3 1 PROCEEDINGS

() 2 3

[9:04 a.m.)

MR. CAMERON: Let's get started here. If 4 everybody can take their seats?

5 And we probably will have some people that are 6 joining us as we go along and we'll introduce them when the 7 time comes.

8 What I'd like to do now is before I go over some i

9 of the ground rules for the meeting is to have Don Cool talk i 10 about -- Donald Cool from the NRC welcome us to this 11 ' meeting.

12 And on your agenda you can see that Don was going 13 to be talking about the objectives and philosophy of the 14 rule.

) 15 Well, we're going to switch things a little bit 16 and I will go over the ground rules after Don gives a short 17 welcome and we'll turn to him for the objectives and ;

18 philosophy of the rule. And the, most importantly, turn to 19 all of you to introduce yourselves.

20 Don, do you want to welcome everybody?

21 DR. COOL: This is one of those great times when 22 your facilitator sets you up.

23 Thank yo~u, Chip. I appreciate this.

24 MR. CAMERON: All right.

25 DR. COOL: I do want to welcome each of you here f ANN RILEY & ASSOCIATES, LTD.

\ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

4 1

to the first of the series of meetings that we're planning 2 to hold related to Medical Regulations Part 35. Now chat we 3 actually have a proposed rule on the street, this is 4

actually something like meeting four or so, of you go back 5 and count the series that we did about this time last year 6 as .vnt were trying to get your initial ideas.

7 I hope that in your looking at the rule you'll see 8

that we -- we're listening to at least a few of the things 9 that were talked about. And I'm looking forward to today to 10 continuing that discussion, picking up and seeing how wr can 11 now take what the Commission has taken or what they have 12 agreed is a good proposal to go out on the street and start 13 through trying that process what the weakness is, what the 14 strengths, and see how we can best now move towards a final

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15 rule making.

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16 So that I don't then just completely preclude 17 everything that was Chip was going to do, I'll turn it back 18 to him so that he can tell us how we are all going to 19 behave, act and organize ourselves during the next couple of 20 days. And then we'll actually get on about the business of 21 working on this.

22 MR. CAMERON: Okay. Thanks, John.

23 As most of you know, my name is Chip Cameron. I 24 am the special counsel for public liaison at the Nuclear I

25 Regulatory Commission and it's my pleasure to serve as your l ANN RILEY & ASSOCIATES, LTD.

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5 1 facilitator over the next couple of days.

2 And I would just like to add my welcome and thank 3

you to all of you for taking the' time to participate in the 4 workshop.

t And as you can see from the participant list we 6 have tried to get representatives from all of the broad !

7 spectrum of interest that might be effected by this rule 1 8 making or 'nowledgeable about some of these issues. And we 9 have a lot of expertise around the table and I think we can 10 look forward to a good discussion.

)

11 Now, the focus of the discussions will be among 12 you around the table. But we also do have people in the 13 audience and we will be going to the audience after each l 1

34 major issue area to see if there's any comments out there.

15 For those of you in the audience I would just ask

)

16 you, for purposes of our transcription, our Court Reporter, 17 Nancy, is taking a transcript for us. That you'd just state 18 your name and affiliation, if appropriate, when you make 19 your comment or ask your question.

20 Those of you around the table will not have that 21 burden because Nancy is keeping track of who is speaking.

22 And for those of you up here, if you do want to 23 speak if I can just ask you to raise your name antenna like 24 this and that will relieve you of the pressure of hav2.ng to 25 continually raise your hand or keep your hand up. And it ANN RILEY & ASSOCIATES, LTD.

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will also help us to get a cleaner, so to speak, transcript 2 of the - of the session.

Or 3 One of the things that I'm going to try to help 4 you with is to keep the discussion focussed and relevant. I 5 will try to take the name antennas as they come up in order.

6 We may need to keep on a particular topic and may need to 7 defer a particular comment or question until later on in the 8 meeting because it doesn't fit the discussion.

9 For those issues that we raise that we'll cbme 10 back to later, I'm going to write them down up here in what 11 I like to call a paddock, because my interest in horses.

12 But it's also known as a parking lot. We'll put that as 13 those issues to make sure that they get there.

14 I would also just ask you to just speak one at a

/~ \ 15 time so that we can listen to what other people have to say.

Q 16 And I think we're going to have time for all of 17 the discussion that we need to have. There may be times 18 when we need to move on to another area and I'll just ask 19 you to -- to perhaps quickly summarize or to defer a comment 20 until -- until later on in the day.

21 Now, as Don had mentioned we did have two 22 workshops last year on the development of the proposed rule.

23 And the purpose of those workshops was to -- to get again 24 the broad spectrum of interests who were effected by the 25 rule here, to talk about how the rules in Part 35 should be

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7 1

1 changed. And just as important is why they should ce )

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2 changed or why they should be kept the same.

1 3 Now, the Staff considered those comments in

! 4 preparing the draft proposed rule. And I think that you can 5

see, reading through the what's called the Supplementary

6 Information to the proposed rule. The explanation in the

7 beginning the Staff laid out what we heard a4 the 8 facilitated workshops, what the Advisory Committee on

9 Medical Use of Isotopes stated and what the written public ;

10 comments were on various issues of concern.

11 I think one thing that may be instructive as we 12 have our discussions is perhaps the Staff can illuminate

13 what -- what the Staff proposal was in certain circumstances j 14 .and how the Commission might change that Staff proposal when l( ) 15 it went through a Commission review.

j 16 Now, many of you may -- may not feel that the 17 correct position was adopted on a particular provision.

18 Then again, you may agree with that.

i 19 You may think that the Staff or the Commission did 1

20 not go far enough in a particular area in terms of revisine 21 it or that we didn't establish a sufficient rationale for 22 what we did. Or in some cases perhaps we didn't 23 sufficiently explain what the intent of the rule -- that 24 particular provision of the rule is. Or how it's supposed 25 to operate.

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Hall, now we have the cpportunity to actually 2 focus an a proposal from the Com'nission and the Staff would '

3 like to IIear your views on cne provisions in the proprsed 4 '

rule chould they be adopted, should they be modified, why or, ,

5 > why not, what's the objective of the particular provision in

. 6 the rule, an6i is there another way to achieve that 7 obj ect.i ve . And this is where we can try to get creative in e '- terms of coming up with alternatives, perhaps, that may be 5

less onerous on the medical profession but still may be an 10 objective of the Commission in a particular provision.

11 And in some cases you may not think that there is 12 enough data to support a particular provision. And we'd .

13 like to hear that and perhaps how we could get more data.

14 So, I'd like to challenge all of you, including t

. 15 the NRC Staff, to -- to try to think creetively on this.

16 And the agenda today focusses on what I like to 17 cal) the underpinnings of the proposed rule. We're going to +

18 take a look at what the risk basis is. I'm sure that all of 19 you has heard that the Imle is supposed to be what's called 20 " risk informed." And I know that there's differing opinions d 21 on whether it is really risk informed.

22 Well, we're going to take a look at the risk basis 23 for the rules and Don Cool will be leading of f thc t q 24 discussion.

25 And I chink we're going to turn to Dr. Lull to O ANN RILEY & ASSOCIATES, LTD.

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1 give 7s a short presentation tan another look at a risk from 2

5 r.he society -- or from the perspective of the scciety of 3 nuclear medicine.

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4 The second raatter is for certain areas of the rule 5

are there standard in the medical profession that might 6

accomplish the same thing that we're trying to accomplish 7 with the rule.

And therefore we could defer in some case.

And I think you'll see a lot of discussion of that also in 8

9 the supplementary information to the rule.

[ 10 And this section of the discussion is not just are 11 there professional standard out there that could be used 12 instead of an NRC regulatory approach but also are there 13 oconomic incentives that might serve the same purpose.

14 So, we're fortunate to have Dale Austin with us, 15 who's over to my left here, from the Federation of 1' tate 16 Medical Boards, who is going to give us a presentation on 17 how medical boards operate. And we want to put that into 18 the discussion. We'll use that to kick off the discussion 19 of that second rationale on justification issue.

20 We will, at futura workshops, have reyresentativeo 21 from the Health Care Financing Administration and also from 22 the Joint Commission en the Accreditation of Health Care 23 Organizations with us to give that view point.

24 I don't think -- has Jim Miller, from the FDA, 25 made it?

O ANN RILEY & ASSOCIATES, LTD.

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10 1 Okay. Well, he may be at future workshops also.

/~N 2 Now, the third rationale and justification issue 3 is compliance issues.

And this takes a look at -- at the 4 cost of compliance to date -- takes a look at the 5 enforcement issues. And that finishes us up for today.

6 The important thing about all of these 7

rationale -- the three rationale issues -- is to try to 8 connect it, give some examples from the proposed rule where 9

you think that there's implications about, for example, you 10 haven't shown the risk basis for this particular provision.

11 I try to connect it up to the rule.

12 The second day, we're going to come back and we're 13 going to go through the major provisions of the rule and get 14 your comments on those. So, today will sort of be a warm up

() 15 16 for a specific discussion temorrow.

And I would just ask you to remember that you're 17 not just hereto talk to the NRC staff and also to talk to 18 each other. And I would just ask you to relax and speak 19 your mind and enjoy the discussion.

20 As I mentioned, we're keeping a transcript. But 21 also, we are going to do summary minutes from each of these l

22 workshops that we will not only get out to participants in i 23 the workshop but, perhaps more importantly, we're going to 24 send those minutes to the Commission so that they can sort 25 of keep current on what the comments -- what the ANN RILEY & ASSOCIATES, LTD.

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11 1

perspectives are on the proposed rule as we move through the

/ 2 workshop process.

3 And I guess I'd just like to finally recognize the 4 fact that -- that you may not have gotten very much time 5

with the final' version of the proposed rule and we apologize 6 for that. There was some delay in Commission approval of 7 the rule some time past what the schedule was so that we 8 could do this particular workshop.

9 Luckily, I think that by focussing on some of the 10 underpinning issues today perhaps you might not have needed 11 as much time. But we do realize that you're all very, very 12 busy people and that you might have had to do a crash course 13 on these materials. And for that we apologize.

14 I guess that what I'd like to do now is to ask Don

()

15 to talk about objectives and philosophy and then go to all 16 of you for. introduction.

17 )

And I know there's going to be some questions for 18 Don on his presentation and perhaps we can work that into 19 the introduction.

20 But before we go to Don are there any questions 21 from anybody on the agenda or the format, ground rules or j 22 the discussion over the next couple of days? Does anybody 23 want to test their name antenna to see if it really stands?

24 Okay. Well, good. Well, let's go to Don.

25 DR. COOL: Okay. Thank you, Chip.

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If I can have Penny or Sam or Joe or Lloyd, some 2

one of my folks who are back there go flip on the projector.

O 3 Although I think most of you also have a paper copy of the 4 slides.

5 It's early in the morning. We can probably get 6 away with having the lights dimmed a little bit. Hopefully, 7 most of you had your requisite one or more cups of coffee 8 and we are awake. This would be a much more dangerous, ,

9 risky process if we were to do it right after lunch, for 10 example.

11 What I wanted to do is to spend a couple of 12 minutes this morning to go through and resent the base line !

13 for everyone who was here. Some of you I know, and we have 14 been part of some of the previous discussions. Some of you 15 are relatively new to the process.

16 I'm being told that somehow I'm supposed to go 17 back a slide. I don't thing I'm going to actually do that.

18 The first sheet that you have on your handouts was 19 the previous list of information from the earlier Commission 20 direction to us.

21 For those of you who are not familiar with how the 22 Commission goes about giving the Staff guidance, the nominal 23 process is that we send to the Commission an information or 24 a requested proposal. They consider it. They sometimes ask 25 us a great deal of questions ourselves. And then eventually ANN RILEY & ASSOCIATES, LTD.

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13 I

1 they provide us a series _of directions in what are called i

2 Staff Requirements Memorandum, that which we are supposed to 3 go over and we are required to do.

4 The Commission back now over a year ago had sent i 5 this off on a process to try and revise 10 CFR Part 35, as 6 well as consider possible changes to the Medical Policy 7 Statement and take a re-examination of the whole approach.

i j: 8 Those of you who_have been in this for any length a

9 of time know that that war a step in what was actually a I 10 much longer process in terms of looking at various issues, 11 some external audits, the National Academy of Science's

12 review of the whole medical topic program area, the 4

13 Commission's consideration as part of its overall efforts in f 14 strategic assessment, and then getting to a series of

() 15 specifics that they wanted to find -- have us examine.

[ 16 We took that direction. I don't think there's any i

j l' real reason to go back and go through all the things they 18 asked us to do a year ago. And started down a process last 4

19 year which looked at each of those items, tried to look at 4

20 some of what we referred to at that time at .ome 21 cross-cutting issues, things that cut across the various

$ 22 modalities and the chronologies for dealing with different

, 23 aspects and uses of nuclear medicine.

1- 24 Taking a look at what kind of philosophy should be

) 25 used. And this is, I think, the first thing that's kind of 4 ,

(

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4

14 1 important. There is a little phrase that gets tossed around I 2 the Commission a great deal:

.Q,))

a risk-informed performance 3 . based regulatory approach. And to deal with that, I think 4 it's probably easiest to break that into a couple of 5 components.

6 First is that first half of tile phrase, " risk-7 informed." And we're going to spend some time this morning 8 talking about risk because risk-informed does not 9 necessarily mean that you have an exact correlation of a-10 different level of risk. That you're in an engineering mode 11 and you had done your wonderful lily bent trees (phonetic) 12 and your fault trees and could quantify all of this then you 13 could express that in a nice, probabilistic,-tentative minus 14 (phonetic), whatever per event kind of situation and 15 everyone would have some agreement as to what you -- what 16' you meant by that.

17 Risk-informed, here in this context, means a' great 18 deal more than that because there's a lot of factors that 19 don't fit neatly into that kind of mathematical engineering 20 analysis sort of situation, equation. So, what the Staff 21- tried to do was to try and step back and take a look at what 22 does -- what are the various risks or the various signatures 23 to those risks in the things that we do. At least, in some 24 extent, what is the context in which that's occurring.

25 And then to use that as_ guideposts in terms of ANN RILEY & ASSOCIATES, LTD.

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15 1 constructing - the regulatory requirements that would be in

() 2 the proposed rule. la general, that would mean that for 3 things that were less risky, put that in quotes if you'd 4 like. That there ought to be correspondingly fewer or 5 simpler kinds of requirements that would be in place for 6 those uses. And as you went to more complexity, higher 7 activities, greater risk, whatever kind of scaling factor 8 that you might be using there, that you'd then have 9 correspondingly a greater level of detail and more 10 specificity, more requirements, additional sorts of things 11 to be looked at or specified. So, in general, the sort of 12 structure of the risk and for what kind of approach.

13 The second half of that -- they're actually quite 14 separable in a lot of cases -- ic a performance based kind

() 15 of approach to the regulation.

iG In general, you can write requirements'for people 17' in at least a couple of ways. Again, those who are 18 engineers or otherwise have who have been involved or where 19 you have a system that's really well defined and you have a 20 lot of experience with it, you can write a relatively 21 prescriptive set of things because you know you're covering 22 all the aspects of that particular activity. If you do A, 23 B, C, D everyone will be very, very happy.

24 And a lot of the requirements that are in the 25 current regulations in both in the medical arena and other ANN RILEY & ASSOCIATES, LTD.

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uses of radioactive material tend to be written in those 2 ways for a whole variety of reasons.

3 What the Commission has challenged us to do -- not 4 just in this arena, but challenged the NRC Staff more or 5 less across the board in all of the areas, in the reactors 6 to everything else -- is to determine whether or not there 7 are ways to move to a more performance oriented approach, 8 wherein you establish the base line of what you want to be 9 accomplished, what in general needs to happen in terms of 5 10 performance.

11 And we -- at least some of, or in many cases, all 12 of the individual specificity of how you accomplish that 13 particular piece of performance to the licensee and the 14 conduct of their particular activities.

15 What you have in the proposed rule is a mixture of 16 those two. And, in fact, the Commission, if you went back 17 to the Staff Requirements Memorandum from over a year ago, 18 explicitly told us that we expect that you will probably 19 come back to use with a mission. There are going to be some 20 things which will be performance oriented, because we want 21 you to look at that. And there will be some things which 22 will be more prescriptive, because they are either more 23 closely related to risk or if they are such key attributes 24 that they need to be specified in any case.

25 But one of the things that I would like for us to ANN RILEY & ASSOCIATES, LTD.

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be able to explore throughout this, and particular as we go

( ) 2 through all of the details, is to what extent have we moved 3 in the direction of the performance organization. And we 4 moved too far? Because certainly there are some who think 5 that we have done that. Have we not moved far enough? And I 1

6 I think there are a few people who are in that camp who feel l 7 we haven't gone far enough in that. That may mean, if I'm 8 getting shot from both sides, I having done too bad a job l

9 putting together the proposal. '

10 But to what extent can you do that? One of the 11 dangers, if you're sitting in the Commission's chair or the 12 Staff chair, of a performance based rule, is there are a lot 13 future things that you can grab onto with any certainty as 14 you do a licensing review or as you do an inspection review.

() 15 16 So, you'll see that this rule has a number of places where it states that kinds of activities have to be 17 specified. And in a number of cases, what those 18 specifications or the procedures that have to be done need 19 to include.

20 You'll see that we have stopped short in this 21 proposal of what we used to do which is, " Send it all to 22 me." In the context that we're all big boys and girls, 23 we've had a lot of practice in this now, there's a lot of 24 methodology that's been built up over the course of time, 25 and it's really not necessary, maybe not even appropriate A-

\,,/

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18 1 for all of that a priori review to be going on.

2 The downside, of course, is that if something goes 3

wrong it's a lot more difficult to find, okay, where exactly 4 in this nice little bead chain of events did the particular 5 break happen? Because that's what everyone tends to do.

6 And I include our friends down on Capital Hill because that 7 tends to happen. The second something goes wrong we get 8 hauled down in front of Congress and otherwise get to 9 explain why it is that we could ever possibly allow X to 10 happen. That resulted in the course of time in the present 11 rule which I think most of you probably are aware, has been ;

l 12 driven by a series of events. And we go in and try to fix !

13 whatever particular bead everyone perceived was broken on ;

14 that approach.

/ 15 The proposed rule that you have in front of you 16 breaks a lot of that mold. And we need to consider whether 17 or not we have, in fact, gone far enough or too far in some 18 of those arenas in terms of doing that.

19 You have a huge notebook of material. We tried to 20 generate enough information so that somewhere within that --

21 finding it might be a tad more difficult --

there is is at 22 least some explanation for how we got there.

23 And in particular one of the things that was 24 included -- and I think there's one on all of the chairs --

25 is the guidance document that would go along with the ,

l

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19 1 licensing aspects of this.

)

2 This, again, was an effort -- I won't quite say 3 the first time -- but really one of the first times where we 4 had tried to develop, in parallel with developing the rule 3 of -- the guidance that would be used in terms of applying 6 for and reviewing a particular license application.

7 You will probably find, if you go through it with 8 a fine tooth comb, that we have some places where thete's 9 some slight discrepancies. That always happens whenever .

t 10 you're trying to do things in parallel. I want to publicly 11 extend my compliments to the team that did this because it 12 is a tremendous effort to go through and lay this out.

13 That guidance document was also laid out in the 14 context of minimizing the things that would be reviewed. '

() 15 16 So, it doesn't say, " Submit all of these procedures."

Instead, it takes an approach of, "Here are the minimum 17 things'that need to be part of this. And you can do it 18 either by -- if you are a relatively small licensee or just 19 want to take a standard approach there are a whole series of l

20 things that you can adopt, the standard format of the NRC or ;

21 submit these kinds of impressions, deal with these 22 particular topics."

23 So, I would encourage you to look at the NUREG 24 1556 Volume 9 document that is the consolidated guidance 25 draft. In parallel of this, write down side by side, see ANN RILEY & ASSOCIATES, LTD. l Os Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 !

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20 1 whether it works or not because what we have found is that n

() 2 when you go to actually write down what we want submitted 3 and how we are going to look at it, we di'scovered things 4 that, "Oh, gee, if I had just written the rule a little bit 5 differently then I either wouldn't have had to ask for this 6 or everyone would know -- would have known that I would have 7 wanted it but no one knows because it's not written in the 8 rule."

9 And in fact, there are a number of cases where the 10 rule has lists of -- I call them minimum cut stats, minimum '

11 sorts of things, because as we've tried to write the 12 guidance document we concluded that there were three or four 13 key things that really needed to be addressed somewhere in 14 the procedure, even if it wasn't being submitted to us or l'h

( ,) 15 somewhere in that particular activity. And that's how that

\

i 16 would have ended up in the rule.

17 So, I would challenge you to look at that side by 18 side in the same relationship. A little but later today 19 we're going to talk about the enforcement of inspection i

20 because that's the third piece of this equation. I 1

21 We did not have the opportunity with the schedule 22 which we were on to try and write a new inspection procedure 23 that would go along with this. That's one of the things 24 that we would attempting to do as we now move with this 25 particular process and move towards a final rule.

l)

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4 21 l 1 But again, what are we going to look at when one 2 of my inspectors walks outside or one of the state people 3 walks in to the corresponding location in their state? What 4 sorts of things will we look at? At what point, in what way 5 will we be asking for documentation?

l 6 Because it isn't very helpful to you if, indeed, 7 and all we had managed to do was to change the review from 8 the license reviewer sitting in the office to the individual J 9 who walks onto your site and then proceeds to do all of 10 that -- write you up a long -- list of all the things that 11 that particular individual wasn't terribly happy with in the l 12 context of that particular review, i

13 So, that's a third piece of the equation that we J

14- need to look at.

1 I 15 You will find that there are some things missing.

{ 16 Put that in quotes. No longer present in this proposed 17 addition of Part 35.

18 We've operated under the philosophy that if it was l 19 covered someplace else, any particular Part 20 -- it didn't 20 need to be repeated. There are a few places where we have l 21 referenced back to Part 20, so that everyone clearly 22 remembers that it is sitting over there, but tried not to do 23 a lot of repetition. That maybe was to pool a number of 24 things back out of the rule. That doesn't mean that the I

25 whole concept of surveys have otherwise just vanished, but '

1 l

l

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rather that they were -- we felt that they wer.e adequately

-~ 2 addressed by the Part 20 requirement, which is a more

\"'

3 performance oriented radiation protection standard than 4

trying to reduplicate it, add to, amend to and immeasurably 5 confuse ourselves with a second accounting in Part 35.

6 So, there was -- that's some of the underlying 7 philosophy that goes along with that. And maybe before we 8 thought it was going to work and it doesn't.

9 Okay. We took a process a number of you 10 participated in which included a working group, steering 11 group. Most of the members of the working group tho did the 12 yeoman's job of drafting this 16, 18 hour2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months days, weekends, 13 nights, at home, dealing with computers that crashed, 14 dealing with version controls and all the other things to 15 put together the document.

16 As Chip had mentioned, we had some facilitative 17 meetings during the development of the process. We met with 18 our advisory committee on the uses of isotopes -- the full 19 committee and a number of subgroups, special groups looking 20 at particular issues. Finally went on to the Commission.

21 We got to see a strawman, put that in quotes if you want to, 22 back in January time frame.

23 We went to the Commission at the end of May this 24 year, briefed them on June 17th. At that point the Staff's 25 proposal, called a SECY paper which is, I believe, included ANN RILEY & ASSOCIATES, LTD.

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1 23 1 in your notebook, was released so that everyone had a chance 2 to start looking at it.

C* 3 1 We also now have the Staff requirements memorandum l 4 which the Commission gave us a couple of weeks ago, in late l 5 July, with their agreement, asking for us to do certain 6 things.

7 You'll see that the Commission took some positions 8 and things got left in. Some things got taken out from the 9 Staff proposal on the basis of the Commission's directions.

10 So, you will find some differences between that which the 11 Staff proposed to the Commission, beginning in June, and 12 that which is now in the Federal Register. And as we go 13 through this you'll be able to see some of those, Some of 14 those are very much in keeping with some of the comments

() 15 16 that we've gotten here.

The Commission, in essence, having seen what we --

17 what they've asked us to bring them said, " Yeah, you're I 18 right, that doesn't make a lot of sense."

19 And there were some other things which the 20 Commission concluded it wanted to stay with an approach 21 closer to that which it had in the existing rule, means less 22 participation of the vacation issue. Having looked at all 23 the options and then informed by the discussions we had 24 here. So, we've gone through that particular process.

25 We have three meetings coming up over the next

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24 1 couple of months. Here in San Francisco. We will be in 2 Kansas City in another two weeks.

-~3 There will be some

\

') l 3 discussions in Washington D.C., a little bit later at that 4 beginning of October. There will also be discussions at the 5 All Agreements State Meeting in New Hampshire at the end of 1

6 October.

7 The comment periods, and there are actually three 8 if you add up all the documents. Th'ere's the comment period 9 on the proposed rule itself, which I believe closes on 10 November 12th.

11 Catherine Haney will keep me correct if I mess 12 this up.

13 The comment period on the proposed medical policy 14 statement, which was also published in the same edition of 15 the Federal Register, which closes on the 13th. Don't ask (V)

36 why there's a difference in those dates. You get different 17 people who do the math a different way on the day it's 18 published. So, you've got one extra day on the medical 19 policy statement.

20 And you have the comment period on the NUREG 1556 21 draft guidance document which we are going to close the same 22 time as we closed rule on the 12th. l 23 Now, the reality is if it gets here on the 13th, 1

24 yes, we will probably still have an opportunity to think 1 25 about it.

I 1

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25 1

But the other reality is that we are still very 2 much on a tight schedule. In order to be able to deliver

-3 the package back to the Commission in May of 1999, not that 4 many months from now.

5 So, with the comment period that we have the 6 Commission will listen to a number of things. The ACMUI --

7 medicine, a number of others, looking to see if they can 8 extend the comment period. In fact, that was extended in 9 the Staff's proposal for the legal base line of 75 days to a 10 90 day period. So, it does go into early November.

11 0e will not be able to go a lot farther than that, 12 so that we can go back and interact with the ACMUI and be 13 able to interact with the Commission in the spring of next 14 year.

f~)D 15 So, that's where we are in the process and that's 16 a little bit about the underlying philosophy and approach 17 that we've taken in trying to derive this. Is it a perfect 18 book? No. Obviously not. We can always work on refining 19 things.

20 There are obviously -- there are some places where 21 we had to put down a proposal. And you can tell that 22 because if you had a chance to read through that volume of 23 supplementary information you'll discover that there are 24 questions sprinkled all through there. In fact, we tried to 25 synopses them at one place and it ends up being a very long ANN RILEY & ASSOCIATES, LTD.

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l 26 l 1 list of specific areas where we really are specifically for, 2

f~')

y, very seriously, additional input and refinement because 3 those particulars we know need to be refined.

4 Does that mean that we're not willing to consider 5 comment in any of the other areas? No. Obviously not.

6 It's all open for consideration. But that gives you some 1

i 7 idea of some of the areas where we're particularly looking 8 for additional input, additional kinds of information, 9 additional ideas and approaches.

l 10 The other thing I would like to suggest to you as l

11 you go through your comment book during these meetings and i 12 after you leave when you think about these discussions and 13 prepare some comments that you can send to me is that 14 comments on the positive aspects, the things that you

/~}

( ,/ 15 particularly want to say, because that's the way you would 16 like to see them, are as important as comments on the things 17 that you would like to change.

18 Just as we now go through the process of looking 19 at all the comment and trying to adjust towards a final rule 20 on the basis of that comment it's going to be very critical 21 for me to know those things which you find really important 22 that we did write the first time.

23 So, as not to undue that which was the good of the 24 proposal as a result of negative comments one way or another 25 as we move towards the final.

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27 1

Sc, I would ask for both that which works and why, r~'g 2 as well as that which needs to be adjusted a little bit and

\_)

l 3 brought so that we can devel_p that proposal.

4 With that outline and sort of an overview of the 5

approach I'll turn it back to Chip and be ask to answer any 6 questions. We can engage in a general discussion of some of 7 your issues and start to explore some of the details. Chip?

8 MR. CAMERON: Okay. Thanks for that overview, l 9 John. If we could have the lights back up. What I'd like 10 to do now is to -- to have you around the table introduce 11 yourselves so that we can start to get to know one another.

12 And I think since I wanted to also introduce the 13 NRC Staff that are all sitting in the bleachers out there in 14 the back corner. And we have so few in the audience maybe

/N 15 it would be useful to see who's with us there.

O 16 Now, I think we can go to John for some questions 17 about general philosophy. Remember that Cathy Haney, after 18 the break, is going to lead us through sort of an overview 19 about the proposed rule. So, let's start with Cathy and go 20 around counter clock wise.

21 Introduce yourself. If you have an affiliation 22 tell us about that. Tell us perhaps what your general or 23 specific areas of concern with the proposed rule are.

24 I'll note for Cathy and Diane that thei concern 25 is that they're being worked to an inch of their life with I

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28 1 this thing. And I'll mention that for you.

2.

MS. HANEY: My name is Cathy Haney. I am a 3 section leader in the division of industrial medical nuclear 4 safety. I'm also chair of the Part 35 working group. And l 5 the NRC Staff in the back is working with the working group.

, 6 We also had a subcommittee under the working group that 7 _ developed the guidance documcnt.

8 MS. FLACK: Diane Flack. Also part of the Part 35 4

9 working group. I'd just like to take the opportunity to 10 back up what Don said about providing comments. I think 11 everybody realizes that the net product that you're going to 12 see next year will be a balance of all the comments we 13 -received. So, the positive part is extremely important.

, 14 The other thing is when to send a comment in and

.ID say that, "This is wrong, it needs to be changed", is not as 15 O

16 helpful to us. We really appreciate it if you could tell us 17 how it needs to be changed and also, if you have the time 18 and information to provide us with the text that we need to 19 respond to your comment. This needs to be changed, why? In

20 other words, we're really searching for all of your help.

21 We tried to do the best we could with the proposed rule, but 22 please help us make it even better, Thank you.

23 Mr. Lull: I'm Robert Lull. I'm a nuclear 24 medicine physician, chief of nuclear medicine at San 4

25 Francisco General Hospital where I am actually engaged in a

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1 patient care. I'm also a director of the residency training j 2 program at the University of California, San Francisco. I'm 3 here today representing the Society of Nuclear Medicine, the 4 American College of Nuclear Physicians, and also on behalf 5 of the University of California.

4 6 And I'm not sure if you want uG to, you know, if 7 you want us to make some comments. I'd make to comments or 8 two issues that are of concern, perhaps. And do you want to 9 do it at this time or did it at another time?

10 MR. CAMERON: Well, why don't you -- why don't you 11 do it right now. I would ask everybody to be sort of brief.

12 DR. LULL: Okay. This is kind of informal. Some 13 little scribbled notes here. So, it's part of the 14 informality of the whole thing.

() 15 16 First, I'd like to make a comment that I appreciate the opportunity to participate in the hearing 17 and, in the process, the revision of Part 35, which effects 18 the lives of all of us who are practicing nuclear medicine, 19 and all of the trainees I have currently in our training 20 program who are learning the skills to practice nuclear 21 medicine appropriately. This will have an impact on their 22 future careers in their field and on the patients that they 23 care for.

24 And I think that it's very important that we all 25 speak honestly and openly about what is happening so that we ANN RILEY & ASSOCIATES, LTD.

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30 1.

can achieve the -- the best outcome that will enhance b 2 radiation safety concerns and provide the maximum benefits !

\> 3 to. patients in need of nuclear medicine procedures.

4 And that's one -- my first point, basically, and i

5 one that I'll be addressing later on is the point that j 6 whatever is accomplished in terms of federal regulations of 1 7 the practice of medicine using radioactive isotopes needs to 8

'be done in the context of risk benefit and cost benefit 1 l

9 analysis. And data needs to be looked at in a formalized i 10 way.

11 I would ask some questions and perhaps these might !

12 be answered later by the NRC Staff. We know that for a 13 number of years now the NRC has been collecting. data about 14 what is going to be called in the future apparently medical 15 events but which in the past has been called 16 mis-administrations. Now, that is the -- when the does that 17 a-patient receives either for a diagnostic procedure or I 18 therapeutic procedure is off by a certain amount than what 19 was intended. i 20 I'm -- this data has been collected. I'm 21 wondering if the NRC and the Staff has done what would be --

l 22 seem to be prudent and that is to look at what's happened 23 and what the experience has been with this as we start 24 looking at revising the regulations and this is one of the 25 issues. For instance, there should be lot of data now about ANN RILEY & ASSOCIATES, LTD.

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I 31 l

1 how much does it cost to implement the misadministration N 2 program. So, what is the cost of doing that? And then what U 3 has been the measured benefit of that program? In other 4 words, has there been a benefit that's been achieved for the l

5 costs that have been incurred. And has there actually been 6 any effect on risk reduction? In other words, have we 7 measured the risk and have we shown that this program has 8 done a reduction in risk?

9 I You know, we're talking about lots of regulations ,

10 and regulatory authority. We should look at what's our real l

11 experience been with someching that's been controversial and l l

12 what has the outcomes of that been. As an example, as a 13 trial, as a exercise in the risk benefit / cost benefit i

14 analysis. '

' ~N 15 (b 16 My other point that I wish to make is that we're looking at the probability of significantly decreasing the 17 experience requirements for authorized use of radioactive 18 materials in the health professions. The -- the l 19 authorization to use will be based primarily on meeting 4

20 minimum radiation safety requirements. In the regulations 21 as I' read the voluminous material in the last two days will 22 be basically geared towards primarily and solely towards 23 radiation safety requirements for both the public and the 24 environment.

25 I think that it's very important that any A

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~q,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

32 1 authorization to use radioactive material clarify what's a p 2 very common problem and common mu perception and it should G 3 do so in writing on each license that's issued for an I

4 authorized user under any revision that occurs as a result 5

of these hearings to part 35 in which it states clearly that 6

the authorization to use is based on the individual meeting

. 7 minimum radiation safety requirements and experience. And 8 the experience part of this is experience in radiation

.9 safety, not in clinical aspects. And it should specifically 10- state 'c hat this in no way -- no way reflects clinical 11 competence in the application of radiation -- radioactive 12 materials in the practice of medicine. This is a point 13 which I think is important because there's great confusion 14 out in the real world about whether NRC authorization

) 15 implies clinical competence. And I think one of the points

'16 that the Society is making is that this is being divorced 17 and-it should be clearly stated to clear up this confusion.

18 Those are my two informal comments. Thank you 19 very much.

a 20 MR. CAMERON: Great. Thank you, Robert. Kathy?

21 MS. THOMAS: My name's Kathy Thomas. I am a 22 supervisor in nuclear medicine in Los Angeles, California.

23 And I also' represent Society of Nuclear Medicine technology 24 section.

. 25 A couple of the issues that we're concerned about ANN RILEY & ASSOCIATES, LTD.

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33 1 first would be any standards that are created have a 2 positive impact on radiation safety. And if we can't 3 demonstrate that there is this this positive impact, that 4

there's -- that the level of radiation of radiation is not 5 improved in some way then let's delete it and get rid of it.

6 The second issue is the importance of not 7 diminishing what professional organizations as well as 8 credentialing agencies have already established, and that's 9 the standard or practice -- a standard or core within the 10 medical field. And often we see when government regulations 11 come in there can be the potential of diminishing those 12 standards by setting this minimum level that is far below 13 what we all know and practice in today's medical 14 environment. So, those are the two issues that teche are

() 15 16 concerned about.

MR. CAMERON: Okay. Thank you, Kathy. Terry?

17 MR. FRAZEE: I'm Terry Frazee, the State of 18 Washington, Division of Radiation Protection. I'm 19 supervisor of the radioactive material section. The couple 20 of issues that I'm interested in -- as the State Radiation 21 Control Agency we're called out on all sorts of events.

22 We've noticed an increase in the nunser of hot loads 23 received at sanitary waste facilities in the state. And the 24 majority of those hot loads have been due to patient -- -

25 Title 31. The patient waste.

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34 1 We also -- we got scme anecdotal information about

/ 2 what patients will agree to doing just to get out of the D} 3 hospital. And in fact they'll do just about anything else.

4 So, issue number one is what is the real impact of 5 releasing patients with higher activity levels then we've 6 seen in the past.

7 Another issue deals with technologists. From our 8 perspective the folks that are really hands on, particularly 9 with low -- low risk -- are the technologists. And we've 10 supported training or testing of technologists and that has 11 been discussed and that's not a topic for here, but I'd like 12 to just raise that as an issue again.

13 And finally, as of reinstate we will have to a.

14 compatible and equipped with the NRC and some of the

() 15 16 designations we'd like to take a closer look at.

MS. HOBSON: I -- my name is Nikki Hobson and I'm 17 in the process, I guess, of being appointed to the patient's 18 rights seat on this committee and very excited about 19 serving.

20 My organization is the National Association of 21 Cancer Patients. So, my comments be a little bit skewed 22 towards that group of patients. But you will forgive me if 23 I do. I'm sure that some of our concerns would be just as 24 valid for other patient groups.

25 Primarily, I think, you know, we are concerned ANN RILEY & ASSOCIATES, LTD.

{)g g_ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

35 1 about risk and about safety. But, you know, a cancer's

,f] 2 patients concern about risk is kind of relevant to other D 3 health problems that they have and sometimes they are 4 willing to accept more risk if there is a potential of 5 benefit.

6 So, we don't think risk, you know, should -- or 7 could be just ruled out. That is a sort of necessary

( 8 element of treating cancer patients.

I 9

We are concerned about access to an every day 10 medical process that would possibly benefit us. We want 11 that -- we want those processes delivered by a competent, 12 well-trained personnel, medical personnel. Clinical --

13 clinical competence, as Bob was saying, but also

)

14 well-trained in radiation safety. You know, there'c no pd 15 point in taking unnecessary risk if there's no benefit, so 16- we do expect our health care providers to be good radiauon 17 safety experts in addition to their clinical competence. !

-1 We want these processes available at reasonable 19 cost. And easily available. That is, that an average 20 pat! nt would not have to travel more than 50 miles to get 21 any procedure that would bf rth h fhe condition.

22 Now, to the extent that regulation such as what 23 we're looking at here support those goals, access, 24 availability, competence and low cost, we think that those 25 type of regulations are really good.

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36 1

If the regulations, in our view, would tend to be 2

( hindering or diminishing these areas then we might have some

\-) 3 questions about why it should be that way.

I 4 Anyway, I'm looking forward to serving.

5 MR. CAMERON:

And I would just clarify that the 6 committee that Nikki is talking about is the NRC's official 7 advisory committee, The Advisory Ccmmittee on the Medical

8 Use of Radioisotopes. '

) 9 MR. BELK: My name is David Belk.

I'm the 10 director of Environmental Protection Ser" ices at the 11 University of California in the office of the president in 12 Oakland. The reason I mention that is I'm not on the 13 campus. And they wanted representatives here for the 14 > University from the medical side and the -- were

-~

l 15 representatives in the audience.

\'

16 What I'm going to do is I'd like to go into the 17 administration side of the University of California and some 18 of our -- what some of our issues are when it comes to 19 supporting the medical use of radioisotopes.

20 One of the -- the two issues that we have we think 21 should be considered is broad scope licenses at a 22 university, sort of institutional licenses, some 23 consideration should go to why are so many questions asked 24 in details? Why are the licenses so restrictive? Shouldn't 25 the individual institution have more authority for ANN RILEY & ASSOCIATES, LTD.

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1 37 1 essentially determining authorization for the use of

'5 g 2 radioisotopes?

(d 3 We think that -- well, X'll give you sort of an 4 anecdotal bit of history abouc my personal dealing with the 5 licenses for the individual campuses.

C Four or five years ago I asked over the phone for 7 copies of the licenses for the individual campuses. And 8 even on the phone I could see people's eyes glazing over. I 9 finally had the -- that recalled the licenses, she 10 discovered it when she was sick. So, there's a lot of 11 administrative support required internally for the j 12 ' University of California for these licenses.

13 Institutional -- an institutional license would go 14 a.long way in improving the efficiency of these licenses.

i

( ) 15 Another issue that we would like to see considered 16 is the clarification of the word " guide" or " guidance" in 17 the regulations.

18 Also, dealing with other regulatory agencies, 19 state or local agencies within California, these guides 20 often become de far , regulations. And that should be 21 reported. Going to .ck some of the issues that you were 22 raising. A performance based approach to the regulations is 23 one being considered by some state agencies where these 24 guidances or even regulations are looked at as guidance on 25 how to best lead an organization to meet the goal of a ANN RILEY & ASSOCIATES, LTD.

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l 38 1 specific regulation rather than a prescriptive regulation

} 2 giving us ad nauseam details to follow. They don't really 3

contribute to the benefit of the use of the material.

4 MR. CAMERON: Thank you. David Larson?

5 DR. LARSON: I'm David Larson. Good Morning. I'm 6 from the University of California, San Francisco Department 7 of Radiation Oncology. I'm training director of our 8 residency program.

9 There are two -- two large organizations, 10 professional organizations, in the United States 11 representing radiation oncology. One of them is called 12 ACRO, A-C-R-0, or American College of Radiation Oncology.

13 And I'm representing that organization today.

14 There's an another organization called ASTRO,

() 15 A-S-T-R-0, American Society for Therapeutic Radiology and 11 6 Oncology. Th'at will be represented tomorrow, not today, by 17 Dr. John Earle, E-a-r-1-e, from the University of 18 California, Davis.

19 ACRO has -- has one main concern. One predominant 20 concern has to do with training requirements and 21 regulations. The current regulations provide comprehensive 22 training requirements for radiation oncologists using 23 teletherapy or gammanized therapy. And those requirements 24 and regulations have served -- have served patients and 25 physicians well in the sense that typical patients being

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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I

39 3 treated by radiation oncologists have a fair degree of

('

,(

2_ confidence in the safety and efficacy of treatment. So, 3 ACRO was concerned over any potential move that you relax or 4 if you wrote training requirements.

5 I would like to at least make the first of, i I

6 hopefully, many positive statements. Dr. Lull asked for an 7 oncology statement. As I read your proposal it appears that 8 there is no move to relax the training standards as far as

-9 teletherapy, brachytherapy and gamma therapy is concerned.

10 And so we'd like to support efforts on it.

11 MR. CAMERON: Thank you very much.

12 MR. SHOWALTER: I'm Charlie Showalter. I'm with 13 the staff of the American College of Radiology.

14 We have a couple of concerns that are not well

( 15 formulated yet because some of our folks were wanting to see 1,6 the actual proposal and didn't really get a chance to do :

17 that yet. And so we hope to have more positive-things to 18 say later on in some of the later meetings.

19 But I think in general our concerns are in the !

20 area of training and experience. We share the view of Dr.

21 Larson, I believe, on the radiation oncology area, but have 22 some remaining concerns of the diagnostic medical medicine 23 area. We hope to have some proposals or some suggestions, 24' rome ideas to-kick around in some of the later meetings on 25 that.

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40 1

And the other area that we're concerned about that 2

I don't know that the Staff can do anything about, but if we 3

can support you in any way to try to help, we'll be glad to.

4 And that's the schedule that you're under.

l 5 This is such an important revision of such a 6

complex rule that, you know, we're really not very happy l 7

about the fact that you have been told to complete it by 8 next June. And we think that's unfortunate.

l 9 MR. CAMERON: Okay. Thanks, Charlie.

10 David, did you have a -- clarification before we 11 get it today.

12 DR. LARSON: Very quickly. I misspoke. I said 13 that there were two professional organizations. There's 14 actually three. The American College of Radiation is

[] 15 extremely important. Sorry.

V 16 MR. MILLSON: My name is Jay Millson and I'm on 17 staff at the American Association of Clinical 18 Endocrinologists. I'm standing in for Dr. Joe 19 Prendergast --

certainly kept him away from the meeting 20 today. And he will be here tomorrow. !

21 But the main concern that we had and I think we 22 stated it clearly a* previous workshops as well as making 23 comments -- an increase in 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months of practical training 24 for the treatment of hyperthyroidism, thyroid carcinoma.

2 I understand the comments have been made through 7-s g ANN RILEY & ASSOCIATES, LTD.

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41 1

the Commission to the Staff and I understand tha' m 2 information is being submitted back to the Staff that 3 they're working with it or what not. So, we don't have a 4 concern over substantiating the need to increase those hours 5 based upon -- this -- they're all supplying the -- with such 6 uses.

7 We've continued to support that concept at the 8 incoming meetings as well as working with the NRC Staff to 9 see what we can come up with.

10 MR. CAMERON: Okay. Thanks, Jay. Bill? l 11 MR. EHMIG: Good morning. I'm Bill Ehmig. I'm 12 representing CORR, the Council on Radiopharmaceuticals and 13 Radionuclides. This is an industry trade group of companies 14 that make, distribute Radiopharmaceuticals, radionuclides, I\

%,,/ 15 sealed sources, unsealed sources.

J 16 I have one concern. I'm going to defer most of 17 the concerns of CORR to my colleague, Roy Brown, who's a 18 regulatory type and is much more knowledgeable.

I 19 But I have a socioeconomic one. In an environment 20 where 35 percent of medicine is practiced in public sector 24 medicine, Medicare, Medicaid, Medi-Cal. You call it. And 22 in nuclear medicine a disproportionately larger percent of l

23 the patients are being paid for by federal agencies.

24 And in an environment when ICVA is trying to 25 rachet down reimbursement, when practice expense for a ANN RILEY & ASSOCIATES, LTD.

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(,- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

42 1 physicians can reduce 15 to 30 percent, depending on the gg 2 specialties, I would be very loathe to see a regulatory

-> 3 environment change that would induce significantly 4

additional costs with little or no benefit to either the 5 manufacture, distribution or clinical use of radionuclides 6 and Radiopharmaceuticals. It just isn't cost effective.

7 And I think it could do great harm to the practice of the 8 profession.

9 MR. CAMERON: Thank you, Bill. And we will have 10 some opportunity at future workshops for some input from 11 ICVA people. And'I would just also add at this point the 12 point that Charlie made about future workshops. This is 13 sort of evolutionary, so that when representatives from the 14 various organizations come to the Kansas City early October

( 15 workshop we may have an opportunity to clarify a point on 16 some of the -- some of the issues that you're talking about 17 today.

18 Richard?

19 MR. HEUSER: Yes. Thanks. I'm Rich Heuser. I'm 20 a cardiologist representing the American College of 21 Cardiology.

22 I'm a practicing cardiologist. I've been doing 23 interventional cardiology for about 20 years and training 24 fellows. And I really appreciate Nikki's comments because I 25 guess the number one thing for me are the patients.

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43 1 The American College has been involved with this

("'g -2 organization from the diagnostic side, obviously. But also V

3 what I'm concerned about and -- is the intervascular 4 brachytherapy, which is still very-much investigational for 5 us in cardiology.

6 We have welcomed the involvement with radiation 7 oncologists, medical physicists, NRC, our institutional 8' -review boards as well as our state boards for regulation in 9' .that this is a very exciting field but a new field. Half a 1

10 million procedures are done.

11 Angioplasty type procedures are done around the l

12' United States right now. Forty percent of those fail. The 13 patients come back. The early results in patients suggests 14 that intervascular brachytherapy, brachytherapy may reduce f

() 15 16 the recinossis (phonetic) by 50 percent.

1 I

I say that with very, very small numbers. This is l

17 very early And I think that that's important because there 18 are 25 to 30 different trials going on with totally 19 different sources, different utility of devices. For 20 instance, there's studies done with radioactive stints.

21 Believe me, I've fished stints out of Hong Kong, Japan.

1 22 I've done it all over the world. I've lost tens of '

23 patients. It happens. That's part of the procedure.

I 12 4 'That's going to be a lot different. If that's approvable 12 5 and if the device that's used around the world or, O ANN RILEY & ASSOCIATES, LTD.

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44 1 specifically, United States. Then if beta radiation at the

() 2 time of an angioplasty is done.

3 Do, we don't even know what's going to be out 4 there. And I think it's in a state of evolution. And the 5 reason I say that is that I think that at this time, from 6 the American College of Cardiology standpoint, and as a 7 practicing cardiologist I'm happy you are involved with 8 putting regulations, but I'm a little surprised with the 9 small numbers. Really. The numbers are so small it's 10 certainly not proven to the field of cardiologists out there 11 and if'it ends up that it's as widely applicable as it could 12 be , I think the onus is on us to make it available to 13 patients so they don't have to travel a long distance.

14- Right now there are only 35 centers doing this.

./~T

- ( ,/ 15 If it's widely applicable and approvable for a simpler 16 device, then I think the training and expertise is going to 17 be different than if it't a wide spread of different devices 18 out there. And I think that that's why we would cupport, 19 since it's not approved at this time, that our training 20 program in intervention cardiology for our first 21 certification board is on November of 1999. Training for 22 radiation safety is going to be an important aspect of that 23 training. And I think when we get approval of this device 24 we'll be able to define exactly what the training is. But 25 ,

right now we would really support considering intervascular O ANN RILEY & ASSOCIATES, LTD.

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45 1 therapy in the example of emergent technology from the 2 standpoint of regulation.

{}

3 - MR. CAMERON: Thank you. Susan? l 4 MS. MCLAUGHLIN: My name's Susan McLaughlin. I am I a.

5 director of environmental clinical and safety standards with j 6 the American Society of Health Care Engineering. ASHCE is 7 one of the personal membership groups of the American e 8 Hospital Association in Chicago and I am here representing.

9 the AHA.

[ 10 In my role I am involved with health care safety )

! 11 and regulatory compliance. And that's the perspective with i'

l 12 which I will be looking at what we do here today, j.

13 From-the standpoint of safety obviously in the I 14 health care organizations, both for the patients, the staff

() 15 and everyone else involved.

) 16 And also from the standpoint of regulatory 17 ' compliance, both in terms of feasibility, for practically 18 . implementing these rules, and also from the financial

. 19 standpoint.

l 3 -20 MR. CAMERON: Thank you very much, Susan. l t i

, 21 MR. NEBLETT: My name is Dave Neblett. I 22 represent the American College of Medical Physicists. And I l

23 thank you for this opportunity to be here.

24, We, like a number of others, do not feel very well 25 informed concerning these regulations, although many of us

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46 {

1 are ditch digging physicists and have been digging through I

/\-

ij 2 these ditches for 25 or more years, to respond in such a I 3 short period of time is an extreme stress and strain.

4 And whatever we can do to assist you in getting a 5

little bit more time so that we can respond, we are very I 6

deeply. involved in many of the technical and minute aspects 7 of these regulations and therefore need time to consider, to ;

8 discuss and come back with positive solutions to common 9 problems.

10 And we also are looking to provide the best 11 patient care and best patient public safety that is 12 attainable within a reasonable cost. !

13 MR. CAMERON: Okay. Thank you for that offer 14 there.

() 15 16 MS. MARTIN: Hi. I'm Melissa Martin and I'm representing the American Association of Physicists in 17 Medicine.

18 Basically, to follow up on what several people 19 have commented, the number one comment that we solicited 20 from the quick round table discussion of the representatives 21 that are coming to the future meetings as well as this one !

22 is at this point we have not identified or certainly haven't 23 time to make an official response.

24 I am really sitting here today to provide what l 25 input I can. Again, the AAPM would be most interested in r~' ANN RILEY & ASSOCIATES, LTD.

Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

47 1 whatever we could file with you to get an extension on the 2 comment period. We -- we know it came out literally, we're 3 sitting here reading it along with everyone else trying to 4 get suggestions back from our members that we can forward to 5 you for just those occasions where you're asking for what 6 are suggested practical considerations. We realize the same 7 problem. It does no good to say, " Change it" if we can't 8 give you a suggestion of how to change it.

9 The one thing that hasn't been brought up that at 1 10 least the physicists felt at our round table last week at ,

11 the national meeting was that -- I think one of the l

12 discussions that's coming up is when do we have to have a 13 radiation safety committee or when should a radiation safety 14 committee be required. As a point of discussion, our 15 philosophy was as soon as you institute any facility that's 16- going to perform therapy procedures we should require a 17 radiation safety committee because that's an oversight 18 committee that coordinates nursing, physicians, t

19 technologists, all the personnel involved. And when you're 20 doing therapeutic procedures we felt very strongly that that 21 should be a requirement.

22 MR. CAMERON: Okay. Thank you, Melissa. We'll 23 have further discussion on that, that specific requirement 24 later on.

25 MS. MANNING: I'm Mary' Pat Manning and I'm a i'

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48 1 clinical nurse specialist in radiation oncology. And I'm

(

2 representing the Oncology Nursing Society. And I am glad to 3 be here and I've heard a lot of things that I would have 4 expressed already having been said. So, I look forward to 5 .giving my comments as we move along, positive as well as 6- constructive.

7 MR. CAMERON: Thanks Mary Pat. Roy?

8 MR. BROWN: My name is Roy Brown. I'm the '

9 director of regulatory compliance for Malprod. Malprod is a 10 major radiopharmaceutical manufacturer. I'll be here today 11 and tomorrow. I'm here representing CORR, the Council on 12 Radionuclides and Radiopharmaceuticals. I'm chairman of 13 their health care committee.

14 Two philosophical comments. I'll have more 15 specific comments later. But two philosophical comments.

)

16 First of all, on the risk informed performance 17 based concept. This is something CORR's been pushing for 18 all along. It went back to DSI 7 and the strategically base 19 lining and even back as far as the IN report.

20 This is something we've felt very strongly of. We 21 wanted to see what was the activity, such as diagnostic 22 nuclear medicine, de-emphasized or even deregulated.

23 At one point we were even hoping for a general 24 license for low risk diagnostic nuclear medicine, as we see 25 in the Part 35, but we didn't get there.

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49 1

I do want to comment that it seems like a lot of

(^

(

2 prescriptive regulations have been removed and we really are 3 going more towards performance based, which we really 4 appreciate. Maybe we didn't go as far as we would have 5 liked to have seen, but we definitely see the improvements 6 in the proposal.

7 The second philosophical comment was on the 8 medical policy statement. I think a lot of the concerns 9 that the' industry has had over the last several years is 10 really NRC Staff adherence to the medical policy statement.

11 The old statement from '79 had language in there about being 12 intrusive and interfering with the practice of medicine.

13 And I think that's where a lot of the concerns from the i l

14 industry have come from. '

ID 15 I like the revisions you've made, or the revisions

'w) 16 you're proposing. I think they make sense. But I also do 17 want to point out I think it's very important the Staff 18 follow the medical policy statement. I think that's what :

19 most of the problems and most of the concerns from the 20 industry come from.

21 MR. AUSTIN: I'm Dale Austin with the Federation 22 of State Medical Boards and I'm pleased to be here.

23 I guess first of all to share a perspective on the l 24 work that medical boards do in this country.

25 And then secondly to, I guess, to articulate on 7~N ANN RILEY & ASSOCIATES, LTD.

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( ,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

50 1 their behalf a -- a need for information flowing in the

() 2 other direction as well that if there are actions or 3 sanctions or problems with -- with individuals, physicians 4 in particular, as it relates to whatever rules are adopted, 5 finalized, those need to get back into the medical 6 regulatory arena. I'm not sure that they do today from --

7 well, I can discern in talking with both member boards as 8 well as our own evidence. So, that would be my other issue.

l 9 MR. CAMERON: That's an interesting topic that 10 we'll revisit. More of a routine information flow to the {

11 medical board community from the -- from the NRC, perhaps.

12 Good. Thank you. Ed?

13 MR. BAILEY: My name is Ed Bailey. I'm chief of 14 the Radiologic Health Branch in the state of California.

() 15 Ne are an agreement state with the Nuclear 16 Regulatory Commission. However, for the most -- for the 17 time I've been here, which is going on about 10 years now, 18 we've been a disagreement state. And we have had a great 19 deal of disagreement with regard to the regulation of -- of 20 the use of radioactive materials in medicine. We are one of 21 the states that never got around to adopting the QNP. We 22 don't see that we have that many more misadministrations 23 and/or medical events than RC.

24 I do sympathize with the University of California 25 because I know they do have the largest broad license in the

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51 1 world for UCSF with 129 conditions on it. So, when they

N 2 started copying that it was quite a job.

(d 3 l

1 I'm here also representing the Health Physics l 1

4 Society who has been active in this process. I was asked by

)

5 President Keith Danger to come to the meeting and begin to 1 i

6 gather information for them in preparing their comments.

7 One of -- I guess the things that I will be 8 looking at, particularly, as we discuss this proposed rule I 9 is the impact of the proposed rule on the agreement states 10 which will get to the levels of compatibility that are 11 identified in the proposed rule.

12 I will also be looking at it from the standpoint 13 of its impact upon health physicists. And I would hope that 14 those -- those concerns are almost parallel.

() 15 One of the issues that has been raised is the 16 committee. And I think both the Health Physics Society and 17 certainly California, as an agreement state, would urge that 18 there be somewhere in the regulations identified a radiation 19 safety committee with responsibilities and authorities to do i

.20 things.

21 The third thing that is a concern to me, since I !

22 do work for a public health agency, the California 23 Department of Health Services, is the quality of medical 24 care and public health. And I think that those two do not 25 have to be mutually exclusive.

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1 52 l 1 I did notice in my notebook that I got, just to 2 prove that I looked at it, that I think you did an admirable 3 job in the present Part.35 by eliminating every other page. I 4 You definitely shortened down the rule by about half, ;

5 MS. HANEY: That.was a test to see if you read it.

6 We did have a couple of binders that went out-that we and we 7 caught two of them. If there are any others, if you'd let- i 8 us know we will -- we do have copies to hand out.

9 MR. BAILEY: You'll always be treating me special, 10 so I --

-11 MS. HANEY: We do.

-12 MR. BAILEY: -- I appreciate it.

13 MS. HANEY: The other two binders went to NRC 14 Staff, so that -- that makes it any better.

15 MR. CAMERON:

(- ) And they might not notice.

16 MR. BAILEY: Thay've got it memorized.

17 MR. CAMERON: That's right. That's what I meant.

18 Let's go out to -- to the audience. And we will 19 get a hand held mic shortly so that will facilitate people 20 talking out here through the -- the next day. So, today and 21 _the next day.

.22 We do have people here from the NRC Staff and also 23 ' people who have been on the state federal working group that

-24 spent a lot of work to develop this rule. And I'd just like 25 them to introduce themselves right now.

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! l 53 4'

i 1 David, why don't you go to the mic and --

2 MR. WALTER: My name is David Walter and this is 3 not on.

4 MR. CAMERON: Is that mic working?

51 THE REPORTER: Yes.

6 MR. CAMERON: Okay.

7 MR. WALTER: My name is David Walter. I'm with 8 the licensing division of the Office of Radiation for the 9 State of Alabama. I'm also -- on the Part 35 working group 10 working with the NRC is reforming and revising these set of 11 rules. And I appreciate any type of input that we can get 12 here.

13 And I will tell you right now that input that we 14 received during the previous public meetings last fall was

() 15 16 definitely used in the revisions that occurred. And if the revisions could continue to go on long after the January 17 30th draft was posted to the web, there are so many changes 18 that occurred. If you look at the two of them you'll see it 19 has been an extremely dynamic document, right up until-last 20- Friday. If it couldn't have gotten out any earlier, it

'21 would have been. I was getting daily e-mails, "Well, it's 22 here." And this is being changed and this is begin changed.

23- 'So, please believe me, everything that you got was got to 24 you as quickly as possible.

o 25 MR. CAMERON: Thanks David. Lloyd?

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54 1 MR. BOLLING: I'm Lloyd Bolling. I'm with NRC's 2 Office of State Programs. And my particular interest in 3 this rule making is the applicability to the agreement 4' states. So, if you have any comments or questions in that

, 5 area, I'll be glad to receive them and present them to the j 6 working group.

7 MR. CAMERON: Thanks Lloyd. Penny, do you want to 8 go ahead?

) MS. ZISERA: I'm Penny Lan Zisera. I'm with the i 10 NRC's Region-One. I'm also a member of the working group 11 and the -- each document that you have is part of my group's 12 work as well. So, any comments you have. Particularly, 13 which document, and I'll be here in this particular city.

14 MR. CAMERON: Thanks Penny. Marj orie?

l 15- MS. ROTHSCHILD: I'm Marjorie Rothschild with the

)

16 USNRC Office of the General Counsel, Division of Rule 17 Making. And I'm also a member of the NRC Staff working '

18 group.

19 MR. CAMERON; Thanks Marjorie. Sam?

20 MR. JONES: I'm Sam Jones. I work with Cathy 21 Haney I'm a member of the NRC working group. If you have 22 any comments on the medicine area. Discussion during the H23 break -- the meeting. ,

24 MR. CAMERON: And Joe?

4 25: MR. DELMEDICO: I'm Joe De1 Medico. I'm the senior ANN RILEY & ASSOCIATES, LTD.

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55 1 enforcement specialist with the NRC's Office of Enforcement.

/~N; 2 My background is nuclear medicine technology and

\s /

l 3 radiopharmaceutical science. I just say that so you !

4 understand I am not an attorney.

5 I'm interested in your comments on the NRC 6 enforcement policy. There's sort of a window of opportunity l 7 to effect some change in the policy. Cathy set aside a 8 little bit of time this afternoon for me to tell you about 9 that. I can, you know, listen at that time. We can also 10 meet informally -- the comments. I certainly don't want to .

l 11 go back to my management and say, "No one had any comments."

12 If I do that they won't send me to anymore of these 13 meetings.

14 MR. CAMERON: Okay. Well, good. We'll look

(%-)) 15 forward to that when we get to the compliance issues.

16 I'd like to get at other people in the audience 17 and I should say that some of the people here, including 18 someone that will introduce themselves next, have been a 19 tremendous help to us in terms of identifying participants 20 for the particular meetings and also helping to identify 21 agenda issues. And I just wanted to thank them here and 22 now.

23 And David, do you want to introduce yourself?

l 24 MR. NICHOLS: My name is David Nichols. I'm with l 25 the American College of Nuclear Physicians and Society of

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56

1. Nuclear Medicine and served as their director of public

) 2 relations.

3 I think we talked about a couple of issues that 4 we'd like to see addressed during this workshop and part of )

.j l

5 the rule making process. l 6 The first is how comments from the workshop and 7 the stakeholders throughout the comment process are 8 incorporated-into the Commission's decisions. And one 9 decision the Commission made on patient notification was one l

10 that really surprised us in light of the fact that at almost 11 all of the workshops that the NRC held and all the comments t,

12 and the comments they have from their advisory committee 13 recommended that they not have a federal requirement for 14 patient notification. But that still made it to the final 15 rule.

l 16 So, I think it will be interesting in hearing how 17 the Commission will be reviewing the transcripts that come L 18 out of this and summaries that come out of r.hese workshops 19 so that we are convinced that they are aware of the public 20 comments and that they justify why they're going into a 21 consensus of stakeholders.

22 The issue is the fact that we're concerned, as the

23 process goes along as this continues to evolve, that new l

l 24 requirements will come up as you start to develop the final 25 rule. And that we could be in a situation where there are l

(

l .

~

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l 57 1 regulations that have not been reviewed by the public or not

! /'"3 2 have any comment on, put into the final rule, and then

! V l

1 3 there's no opportunity to have those changed or evaluate 4 their impact. And those are the two issues.

5 MR. CAMERON: Okay. Thanks David. And we will be 6 trying to alleviate the problem that you referred to a 7 little bit by the meeting summaries that we will be 8 forwarding to the Commission.

9 There's another aspect to that whole problem is 10 that the Commission may know about it, but for various 11 reasons decided not to adopt the position it was -- that was 12 recommended. And I think on that substantive aspect when we 13 get to patient notification perhaps Cathy, Don or Diane can 14 perhaps fill us in a little bit more about what was

[~)

L) 15 motivating the Commission in terms of that particular 16 requirement.

17 So, thank you. Andrew, do you want to introduce 18 yourself?

19 MR. WOODS: I'm Andrew Woods. I'm a partner in 20 Charlton, Hasting and Provage (phonetic) in Washington, 21 legal counsel to the American College of Radiopatient 22 Oncology.

23 MR. CAMERON: Okay. Thanks, Andrew. Let's see.

24 Is this on? Okay.

25 MS. SCHWEYAR: I figured I was in front so I'd be rN ANN RILEY & ASSOCIATES, LTD.

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58 1 one of the first ones.

2 MR. CAMERON: That's right.

3 MS. SCHWEYAR: I'm Jill Schweyar.

J I'm the vice 4 president of regulatory medical oncology affairs from 5 industry. The name of the company is Isostint, 6 Incorporated. We are actually in the business of 7 international work, radiotherapy using radioactive stints.

8 So, having had a real opportunity to study the rules and 9 regulations for it, we have multiple areas of concern. I'll 10 just list those briefly. We will prepared at future 11 meetings to make a more formal statement. But basically, 12 we're concerned in the area of turning requirements, and we 13 do appreciate the Commissions approach in this performance 14 management. I think that's going to lead us in the right

. (}

y 15 direction. Especially with out technology.

16 We're also concerned about the licensing

17 agreements for hospitals if this technology does become 18 available. We want to make sure that if it does become 19 available and it is going to be medically available to all 20 patients who need the therapy.

21 We're also concerned about misadminsitrations.

22 Because stints during interventional cardiology procedures 23 do have a tendency occasionally to be dislodged or can be 24 placed at a different location in the vessel. So, they are 25 concerned about how that will be recordable.

i (g

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59 1

Also, we're concerned about the NRC also getting 2 into the areas that are actually regulated by the Food and i 3 Drug Administration. So,-we want to make sure there is a 4 . separation there.

5 Also, our therapy is low does rate and we want to t 1

6 make sure that it doesn't get confused and regulated as a 7 high. dose rate radiotherapy source. Then, of course, 8

there's the sealers and unsealed source category and trying 9

to make sure that our stints do remain an unsealed source.

10 Thanks.

l L 11 MR. KNIGHT: I'm Dean Knight at.a I'm also with l

12 Isostint, chair at Johnson Severson (phonetic). )

13 MR. PRICE: I'm Dr. David Price. I'm the nuclear 14 medicine physician practicing here with UCSF. In that sense 15 (f I'm with the University of California and with "t e Society 16 of Nuclear Medicine and the ACMP. I've been practicing 17 nuclear' medicine for 13 years and I've seen a lot of changes 18 in that time.

19 There are two issues which I wanted to mention 20 which are not simple resolution issues, but which troubled I

21 me. One is we're talking about setting the resolutions 22 based, amongst other things, on risk -- called risk 23 informed. And my concerned is what is the expertise in the 24 NRC on assessing risk. Radiation risk is one of the most 25 controversial issues, as you all know.

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60 1 There isn't any medical expertise in the NRC. Dr.

1 2 Pollico (phonetic) has been vising for several years, but l 3 there really isn't a permanent position there. I don't know

~4 of a radiobiologist, and I may be wrong there. But again, !

5 my. question is we in the nuclear medicine and the --

{

6 community are very concerned when the risk is the basis for i I

7 establishing regulations and really what is the actual 8 tease. The -- community is a community that meets on an i

9 occasional but regular schedule and is an advisory !

10 committee, not a fundamental part of the NRC.

11 The other issue that concerns me is that-there has 12 been sufficient concern recently to reduce public exposure 13 from .5 gram to .1 gram. On the other hand, we're talking 14 about changing regulations of the way which we used to set

/ 15 training requirements. And I find a fundamental dichotomy 16 in that position by the NRC that they're concerned about 17 radiation exposure on the one hand and yet they're willing i 18 to relax standards of education on the other. . So, again, 19 we'll put that on the table as something that needs 20 resolution.

21 MR. CAMERON: Okay. Thanks Dr. Drice. And I 22 think we'll have an opportunity to visit both of those 23 issues as we come along, particularly the first one about 24 the need for risk information and indeed, who is going to 25 supply that.

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61 1 MR. HOW: My name is Mark How and I'm the service 2 health care. radiation safety officer of the University of

. {a"~}.

3 Chlifornia, San Francisco.

4 I'm interested in the topics that Dr. Price has 5 just raised.

6 MR. TAHMASSIAN: My name is Ara Tahmassian. I'm I

7 the assistant vice chancellor for research support, which l

8 includes radiation safety. I am the author of the 421 each !

9 license in -- division with 120 -- I do have, obviously, a 10 comment to make.

11 But seriously, I think that as a group making 12 process for this I think what we need to do is really focus 13 on what is important versus what is sort of good for the 14 purpose of your having paperwork. We can have all the

() 15 paperwork you want. We can have piles and piles of 16 document. It would not be a safe program. We can have a 17 program with four pages of documentation und it would be the 18 safest program.

19 One other thing that I would like to put on the 20 table. I have worked under about 16 different agreement 21 states. I've needed an NRC license, Tou know, for several 22 . years. There is this -- this new licensing versus 23 enforcement licensing, they can say anything they want with 24 regards to the process of granting a broad spectrum license, 25 being, you know, sort of performance based. But trust me, ,

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62 1 when you-get to the bottom line, it's licensing because if

)

'2 the micro detail that you have to make life easy for the 3 enforcement folks because they have to go through the 4 checklist. And I want to make sure that in this process we 5 get an opportunity to address that very specific-issue.

I 6 Thank you.

7 MR. CAMERON: Good. Thank you. And we will 8 address that this afternoon.

9 MR. HOLMES: John Holmes. I'm at Stanford 10 University. The same town, sir. Also, in the UC Stanford 11 Health Care System South and the Palo Alto Veterans 12 Administration Affairs Hospital.

13 MR. CAMERON: Thank you.

14 MR. HICKMAN: John Hickman. I'm with the State of j) 15 California. I'm in medical licensing. And you should have ;

16 seen Ara's license before I put it down.

17 MS. GOODE: I'm Tara Goode. I'm a medical license 18 reviewer for the State of California, the radiological 19 branch.

20 MR. CLIFFORD: I'm Jeff Clifford with the State of 21 California, radiological health branch. And I'm medical 22 license reviewer also.

23 MR. PAY: My name is Steven Pay. I'm with the 24 radiological health branch, State of California. And I'm a 25 compliance inspector with inspection compliance enforcement.

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63 1 MR. CAMERON: Great. Thank you. I'm glad to see

2 that our -- some of Staff people from our code regulators 3 are -- from the State of California are here today. And Ed 4 and Terry, I know you don't mind me using the "C" word, code 5 regulator.

6 Okay. Well, I think we have a, great group, both 7 in the audience and around the table to do some productive 8 discussion of these issues. And we're a little bit behind 9 time for our break. But I think Don has been listening to 10 many of the -- well, I know he's bene listening to many of 11 the issues that have been raised.

12 Does anybody around the table have any questions 13 for Don about regulatory philosophy, schedule, broad issues

14. such as that before we -- we take our morning break here?

15 [ Discussion off the record.]

(O)-

16 MS. HANEY: Okay. In the area of the general 17 technical requirements, under the proposed rule, where you 18 see the requirements for the training and experience of the 19 radiation safety officer, for the medical physicist. Then 20 you go into what we start --

started calling the modality 21 specific sections of the rule.

22 What we tried to do was to maintain somewhat of a 23 current framework that in the current ruling you have the 24 requirements for the 35-100 uses which would be the use for 25 in your -- for uptake and dilution studies. That was in one ANN RILEY & ASSOCIATES, LTD.

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4 4

64 1 area of the rule. Then you would go into the next section 2 of the rule, which was your 35-200 uses, which would be your 3 imaging and localizations studies. And the 35-300, which 4 would be the use of the unsealed material for therapy uses.

I 5 And that broke down to really the subparts D and E. l 6 What the difference -- the split in these two

(

7 sections is, when you need a written directive and when you !

1 8 don't need a written directive.

9 If you're using radioactive materials for a use 1 10 where a written directive is not required, you would find 11 the requirements in subpart D.

12 If you were looking to use material where a 13 written directive would be required, now you're into subpart 14 E.

/ 15 The requirements for the authorized users would be k-)

16 found under those sections.

17 The next subpart that you'll see is manual 18 brachytherapy. To let you know, we did attempt, at one 19 point, to combine the manual brachytherapy with the 20 therapeutic medical devices into one part because there were 21 a lot of similarity in the technical requirements. But we 22 did it and we started -- it really got to be too much of a 23 mess. So, we split them off into two separate areas. So, 24 when you are reviewing line by line, word by word of the 25 rule, you may start to see some duplication between subpart g- ANN RILEY & ASSOCIATES, LTD.

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l t

65 1 F and subpart H, but we recognize there was duplication but

('N 2 the alternative was to really jumble it all and start doing, 3 except for this and except for that, which would have been 4 much worse.

5 The subpart D is your -- are your requirements for 6 the sealed sources for diagnosis. Again, the training and 7 experience requirements for an individual wishing to work l

8 under this area would be found in that subpart.

9 Subpart H is a very large subpart because it's 10 intanded to cover ..czetherapy, gamma stereotactic 11 radiosurgery and your HDR use.

12 I would ask, especially of the physicists in the 13 group, that when they are reviewing these sections in detail 14 that they look very closely at the requirements for the HDR

~

.[%.)) 15 units and for the gamma stereotactic radiosurgery units.

16 We did use the AAPM reports to generate the 17 requirements in this section. We tried to make a cut l 18 between what was a requirement for safety and was a quality 19 assurance sort of requirement that should be left to the 20 physicist to decide whether that needs to be done or not.

21 Again, we tried our best. We may have made that 22 cut at the wrong place and we're looking for feedback in 23 that area.

24 Subpart J are the training and experience 25 requirements and you're going to say, "Well, you just said ANN RILEY & ASSOCIATES, LTD.

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66 1 that the training and experience requirements were in the

,(7g 2 other subpart." Once we got into this process we realized V 3 that with out proposal for training and experience that 4 we'll be discussing in deptn tomorrow where the authorized 5 users would have to take an exam and NRC tould be approving 6 exams and certifying bodies that we couldn't make that part 7 of the rule go immediately effective. Because otherwise, 8 once the date that the rule went into effect, then no one 9 could become an authorized user, an authorized medical 10 physicist, until NRC approved the boards, which that was not 11 really a very good situation for patient care.

12 So, we have decided to maintain the current 13 training and experience requirements in the rule and this --

14 these requirements would stay in effect for up to two years g)

/ 15 from the implementation date of the rule.

16 If we go along in the final rule with what we're 17 proposing in this rule, at the end of two years, subpart J 18 would be removed from the regulation.

19 Now, there's a lot more I can say on the training

20 and experience requirements but I'll save that for tomorrow 21 when we get more in depth. But I want you to know why that 22 one subpart was maintained.

23 Subpart K has been referred to as the emerging 24 technology section. If we use the term " emerging 25 technology" we were going to have to define it in definition p)

(

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67 1 space and we didn't want to do that so we kind of took the

(~ 2 easy way out and just set up a subpart K that was for any 8

\')} 3 other medical use that's not described in another subpart.

4 And this -- so, in subpart K it's a very short 1

5 section of the rule, if you had the opportunity to look at i

6 it. But the purpose of having subpart K is that if a new J

7 technology comes into use that we would be easily -- we l 8 would very easily be able to adopt it into the regulatory

1

?

9. framework. About the best example that I can give you for 10 this is when HDR units came into being. There really was 11 nothing in the rule that would make for easy regulation of 12 an HDR unit. And with those that had licenses, teletherapy 13 licenses, and they got the HDR unit, what we started to do 14 was say -- reference the teletherapy section in the rule and 15 say, "Except don't do A, B, and C, but do E and F if you 4 V(~'\

i 16 have an HDR license." And that became, again, a very 17 difficult, non-user friendly way of regulating.

18 So, we have this -- this subpart K with -- for the 19 purpose of a new technology comes into NRC, we are certainly 20 going to ask for information, radiation safety related 21 information on the use of this material. As we get more 22 experience. As the users get more experience with the use 23 of the material in this area -- you know, five years down 24 the line, six years, whatever -- we would finally get to the 25 point where we could do a proposed rule that would be g g. ANN RILEY & ASSOCIATES, LTD.

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68 !

1 specific to this one use and then we would just, in a chunk,

() 2 put it into the existing Part 35.

3 The other two sections, L and M, what we did was 4 take all the reports that were required under the current 35 5 and all the records that were required and moved them into 6 one section. This was done really as to parallel what was 7 done with Part 20, for those of you that are familiar with 8 part 20.

9 Our thinking is that if someone says, "Well, Gosh, l

),

10 what are the records I need to keep in order to be in 11 compliance with Part 35", they just go to subpart L and they 12 see the entire list.

13 If they want to know what reports they need to 14 keep to make to NRC then they just go to the report section.

) 15 And it's not a matter of having to read through the entire 16 document to see, you know, is there a record buried in here 17 some place? Is there a report buried in here? And risk 18 missing something.

19 One of the questions that we have asked in the 20 supplementary information is, "Do you like this approach of 21- moving all the records to one section, of moving all the 22 reports to one section?"

23 So, when you are coming back with formal comments, 24 you might just want to say, "Yes, we like what you did", or 25 "No, we don't like what you did." Throw it back into the O- ANN RILEY & ASSOCIATES, LTD.

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69 1 section where you discuss the specific requirement.

/"'% 2 Subpart N deals with enforcement. These are just 1

3 two sections, more administrative sections that need to be 4 entered in the rule. Other than updating them to reference 5 the proposed section, they're very similar to what's in the 6 current rule.

7 Appendix A, it's a new appendix. It does not 8 appear in the current Part 35. This has to do with the 9 examining organization or entity. Again, we'll talk about 10 this a little bit more in depth tomorrow. But one of the 11 requirements of the rule is that NRC would approve a board 12 or examining entity. And this particular appendix contains 13 the requirements. What we would be looking for in that 14 board or in that examining organization.

() 15 16 And I'm just going to stop there for now with that because -- since I will go into that a little bit more in 17 depth tomorrow, 18 The next slide that you see are some specific 19 questions, as I've said, on subpart L and M that may be --

20 if Chip will give us a couple of minutes we can just address 21' those to get some preliminary views on the record.

22 And then the last thing that I would like to talk 23 about from the standpoint of an overview of Part 35 deals 24 with -- and now you've got an HP operation of a remote 25 control. So.

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70 1 Okay. This has to do with the sections that we r~s 2 deleted from Part 20. Don made reference earlier to one of N ),

3 the items -- one of our things that we wanted to start out.

4 The working group objectives was that if the requirements 5 are discussed in another part of the rule that we would not 6 discuss them in detail in Part 35. Again, this is a little 7 bit of a step away from the prescriptive nature of the 8 current Part 35.

9 What we had tried to lay out in the statements of 10 consideration for some of these is that although these 11 requirements no longer appear in Part 35 it doesn't mean 12 that a licensee doesn't have to do it.

13 In the case of the current rule 3520 requires that 14 the licenses have an alarm program. That does not appear in 15

()

\_s the proposed rule.

16 Part 20 requires the licensee to have an alarm 17 program. And that alarm program would be geared to the 18 uses. So, for example, if you were using very small 19 quantities, you would not have a large alarm program. If it 20 was a large facility, the alarm program might be totally 21 different.

22 The specific requirements for surveys for I 1

23 contamination and ambient radiation exposure rates has not 24 been deleted in total. We did keep one requirement in the 25 therapy area that served in the use of unsealed material for l l

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71-l 1 therapy. But some surveys need to be performed. We I (q) s- 2 recognize this as a prescriptive requirement; however, l

^ ,

3 because of the potential for the risk associated with that 4 we felt that this small aspect of this requirement should 5 still be maintained in the rule.

6 I won't go step by step through all of these. But 7 suffice it to say the licensee would still need to address j 8

all of these particular items, but they would be doing it 9 under a Part 20 requirement rather than a Part 35 10 requirement and we would not be as specific in our rules 11 based on how the licensee would address these items.

12 One thing that I touched on when I was discussing 13 the training and that I think should be brour : out at this 14 point for the discussion on the rule is our .aplementation 15 schedule for the rule. What we are proposing is that the b( .

16 proposed rule would state that the rule, with the exception 17 of the training and experience requirements, would go into 18 effect six months after its publication, which we're 19 probably looking at the summer of 2000 for an implementation 20 date for the rule, with the exception of the training and 21 experience.

22 The training and experience requirements would be 23 two years from the date that the final rule is published. I 24 explained why. Mostly because we need that time to get in 25 to approving the boards.

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72 j 1 The reason for the six months, there are some l j-s 2

-additional procedures that the proposed rule would require

%- 3 that you adopt and those -- we'd give it six months --

4 should provide adequate time for those procedures to be j

5 developed.

6 Some of the other changes and we'll, again, 7

discuss in detail the quality management program no longer 8 is required by the rule but there would be some modification ;

9 to some procedures that would need to be made because the ;

10 QNP has been deleted as a stand alone program.

11 So we, again, we feel that the six months would 12 give an adequate time but of this time of discussion, you

'13 know, comments on whether you think the six months are i

14 adequate or not for the implementation of everything but the 15 trading experience would be appreciated.

16 So, I think I'll turn it back to Chip.

17 MR. CAMERON: Okay. Thanks, Cathy. We will visit 18 the subparts L and M as specific issues. But I think that 1

19 we'll do that tomorrow in the context of a more specific l

20 discusa ton on this. I 21 But to make sure that everybody understands this 22 frame work and, again, given that we're going'to be 23 discussing some of these tomorrow,. But I just wanted to 24 make sure that everybody understands the road map for this 25 . rule. Questions from any of you on this at this point? Ed?

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73 }

1 MR. BAILEY: Could we get Cathy to give us a copy 2 of that slide? That one might be --

3 MS, HANEY: This one? !

4 MR. BAILEY: Yeah. That would be very beneficial, l 5 MR. CAMERON: Okay. Great.

We'll do that. Roy? l

-6 MR. BROWN: Chip, I have a quick question. I 7

thought at one point you guys were shooting for publishing 8' the final rule in summer of 1999. But it seems to be !

9 effective at the end of '99.

10 MS. HANEY: Well, that's what Diane just wrote me 11 a note here that I messed up. And see, I was going to try l 12 to just, you.know, correct it at the Kansas meeting.

13 If we, you know, based on how we did with the

_ l 14 proposed rule we're probably looking at a publishing date 15' for the final rule _of around August, which would, in six 16 months from August, be probably more in-the February time !

17 frame. I just want like longer summers.

18 Now, I'm going to.get corrected again from my 19 left.

20 DR. COOL: Now, I'm going to give the other piece 1 l

21- of the procedure which is different for a final rule than a !

22 proposed rule, which has to do with how the federal 23 government operates.

24 Agencies can publish proposed rules simultaneously 25 with submitting to the Office of Management and Budget the ANN RILEY & ASSOCIATES,-LTD.

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74 1 information collection requirements, and those processes go

("

p} 2 on in parallel.

3 Where the final rule, the Commission would approve 4 the rule. The Office of Management and Budget, OMB, would 5

have to clear the information requirements before the agency 6 would actually be allowed to publish the final rule.

7 So, there is an additional step before the rule, 8 such that August would be some period of time. OMB has been 9 known to act fairly quickly. Sometimes OMB can take up to 10 90 days, I believe. Marjorie may be able to help me out 11 with that, although I'm not sure any of our folks were 12 specific about the clearances. So, there is an additional 13 time step in there.

14 So, the reality is somewhere between -- parallel

()

15 to what happened this year and three, four months for 16 additional when you go through the final rules stage. i 17 Simply because of the processes which the federal government 18 uses in order to meet all the Congressional manuates.

19 So, somewhere between those two. Probably not i

20 quite as late as summer of 2000, although I've seen things i

21 extended for a long period of time. And probably not quite 22 as quick as Cathy's optimistic odds. How is that?

23 MR. CAMERON: Okay. Bill?

24 MR. EHMIG: I have a quick question. How is the 25 NRC addressing the year 2000 issue, and will that effect

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75 i 1 this? I

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2 MR. CAMERON: That sounds like a question for Don I 3 Cool.

4 MS. HANEY: i Well, I have a specific -- I have a l

5 specific and Don can do global.

1 6 MR. CAMERON: Okay.

7 MS. HANEY: From a specific standpoint of Part 35 8 spacing, it really comes into a major play in the area of 9 the therapy uses. And we have added a requirement relative 10 1 to computer systems to make sure that they are basically 11 doing what they're supposed to doing. So, the year -- the 12 Y2K problem would fall under that particular item.

13 We do make mention of it in the Statements of 14 Consideration as an example of something that you would be 15

( ) checking when you were showing -- trying to show compliance 16 with this section.

i 17 So, from a real specific nature that's what we're 18 doing with 25. I'm going to let Don do the more global 19 check.

20 DR. COOL: There are a whole series of activities 21 going on in the agency. Computers -- the 2000 computer 22 program. A lot of that has focussed on bigger licensees.

23 In particular, our 110 operating reactors. Some of the fuel 24 facilities and other facilities where there are a lot of 25' computer controlled process controls in various activities.

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76 1 And the materials around, we face the entire jr g 2 range. On one of the spectrum of my licensees I have fuel V 3 facilities and gaseous diffusion plants. On the other end, 4 I have my portable gauge users who don't have any 5 ' electronics at all that relate to safety. Pure mechanical 6 air locks. In between, I have all the range of things in 7 the medical device arena and everything else.

8 We have been trying to work very closely with FDA 9 in terms of the devices and device approvals because most of 10 the responsibility in terms of the actual software devices 11 rests on that side of the house.

12 There have been several information notices that 13 we even tried to get out to all of our licensees, and I 14 think those have been sent over to the states for f'N~ 15 transmission and state licensees.

16 On that, things we have learned from FDA. Some 17 things that we have learned through a series of questions 18 that we've been asking licensees and manufacturers. We've 19 gone to folks that manufacture some of the data devises 20 asking where they stand in terms of their year 2000 problem 21 so that we can try to get that information out.

22 The next meeting that we have with FDA is, in 23 fact, scheduled before the end of this month just to try to 24 make sure that what we're hearing and what they're hearing I 25 is coordinated and that information gets out, t .

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._ m _ _ . _

77 1 So, that's a multi step piece going on. We're A

2 participating in the executive presidential committees.

3

.We've been in various health care and environmental arenas.

4 Have been providing information and testimony to the 5 Congressional side committees that have been looking at it.

6 And we could spend a lot more time talking about 7- various and sundry other details.

8 If you have -- I'll just put it out there. If you 9 have specific groups within your societies that are looking 10 .at the issues I would love to, as a sidebar, get together 11 with you so that we could be communicating directly back and 12 forth between the individual societies to pick up any 13 information and get that out to people.

14 And let's not loose sight of the fact -- that ft.

\J 15 issue too. It's not like that's a real productive -- ,

\

16 MR. EHMIG: But I've asked a question. You-really 17 dealt there in your answer, which I thought was very good, 1

1 1

18 with your outreach to your regulated people. I've talked to 1 19 people in the Department of Energy and the Department of 20 Defense who say that they will not be compliant with all

. 21 those -- or all of the Y2K until between 2002 and 2004. How 22 are you going to be internally for your own role out of

,23 regulations, maintenance records and the ability to go out 24 and investigate sites, looking at it yourself, not at the

- 25' regulated people?

1 i

^

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78 1 DR. COOL: Okay. The second half. Obviously it's e' 2 locations he's doing internally. And they are both a series 3 of things which are under direct the direct control of our 4 chief information officer. Identify the business critical 5 systems and, for most of the systems, they will, in fact, 6 are on track to be year 2000 compliant through. upgrades to 7 the various software packages, for those for which it is 8 cost prohibitive and ridiculous to take over mainframe 9 systems and do all of the changes. We're doing some of 10 those.

11 There is a second tier which is -- I'm going to 12 get the year 2000 terminology messed up -- there's compliant 13 and then there's a second category which means you have the '

14 contingency plans built in place where if it prints out if~') 15 reports and puts the wrong date stamp or something on the V

16 bottom, tnat you have a way of segregating. You run a 17 report up to here and then you run a second report secondly, 18 which are also being developed so that we can continue to 19 track.

20 We've already been facing this because we've been l 1

21 looking at inspection dates and licensing dates well out 22 beyond the year 2000. So -- and the materials are made. ,

l 23 Our basic tracking systems, like the licensing tracking 24 system and some of those things, have already had to deal 25 with this because we're already running dates that are 2001, ANN RILEY.& ASSOCIATES, LTD. !

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79 l 1 2002, 2003.

2 MR. CAMERON: And for those of you who want to

)

3 take Don up on the coordination issue I would suggest that 4 you talk to Don or his staff sometime during this meeting to 5 set that up.

6 Any other questions before we move on to risk?

7 Does anybody in the audience have some general 8- questions on Cathy's presentation?

9 Okay. Well, let's move into our first rationale 10 and justification issue. And this is the whole idea of 11 risk. And we heard a number of people talk about-risk and 12 risk benefit, cost benefit and the need for data and what d

13 data does the NRC have. Bob Lull mentioned that. And we

, 14 heard Dr. Price's comments about the knowledge set necessary

() 15 to assess risk. And Nikki brought something up this morning 16 about -- that risk is relative to a cancer patient facing 17 treatment.

18 What we're going to do is start off with some 19 contacts for you. Don Cool is going to talk about what the 20 NRC is doing, along the risk lines.

4 21 And Bob Lull has been nice enough to consent to 22 give us an overview of what the Society of Nuclear Medicine 23 views as risk.

24 And there is a handout connected to Bob's 25 presentation that will be handed out by David Nichols to

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80 1 everybody. And'I think we'll just hold -- we'll use their 2 presentations to start the discussions.

(f And we'll let both j 3 of them.go,first before we do that. Don?

4 DR. COOL: Thank you, Chip. As I mentioned a 5 little bit earlier when I was outlining the whole thing and 6 talking about' philosophy, the Commission that we presently l 7 have, in particular Chairman Jackson, has been encouraging, 8 pushing, driving -- you can use some other phrases, less l 9 friendly terms as well -- the Agency in the direction of 1

10 using what risk information is available for-various 11 contacts and settings in regulation and licensing inspection 12 and other regulations.

13 The Agency has, quite frankly, much more 14 experience in date systems with the reactors, systems where

( 15' you'can go through and do tremendously detailed. You're I 16 talking about reams of paper analysis that give bent trees 17 and fault trees and a whole category of things which is l 18 known collectively as probabilistic risk assessment or !

19 probab'ilistic safety assessment type of activities, giving 20 bend trees and fault trees and the notes and diagrams.

21 And assigning probably as a failure or a success 22 to that we're doing a wonderful analytical methodology which l 23 works extremely well when you have systems which have 24 engineering or which you have a lot of very detailed, i 25 predictive data on failures of particular components of the

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81 i

d 1 system, where you have a general -- a defense in depth or

() 2 multiple layer type of approach and it allows you to build a

[ 3. wonderful methodology and construct for dealing with thingo 4 where you can then look and say, "What is the effect of .

5 changing a particular system, taking out a service or j.

6 whatever.it is, on the overall probability of failure, f

7 measured.as a quarter mil frequency or something like that."

8 That works real great in ,an engineering arena, l 9 large system arena. Unfortunately, it's much more difficult i 10 to model humans and to model human interactions and human

11 failures. It's a whole other category of human factors and 12 . human performance and performance shaping factors and a l 13 series-of things which go into that.

14 It's also more difficult where you don't have the i..

.rm j () 15 same sort of structures and systems and defenses which are 3

i

?

16 typically in place in a large facility where a lot of the

17 safety, if you wil7, to use that term somewhat loosely, or 18 the control mechanisms for dealing with material, defending s

j 19 material from being where it's not supposed to be or 1

P .20 applying it in a way it's not supposed to be applied. Deal 21 with procedures for human reactions.

22 That comes most clearly to the fore into -- in 23 this area that we're dealing with here in medical. Because, 24 in fact, the only way that the material can effectively do 25 what we want it to do in.that instance of therapy is to have

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82 1 it directly applied to, interacting with a human.

/'S 2 For a cell physicist -- I'll wear that hat as U 3 well -- we fundamentally try to deal with a time distance 4 is' sue. Keep it away from me. Keep it as low as reasonably 5 achievable. And that is also not a context which directly 6 applies because simply minimizing those, I think as you were 7 telling me, is not what you want to do. You want to 8 minimize the material necessary to achieve your objective 9 for that. Sort of to add some words to that. But you're 10 objecting to the parts and certainly you need a good image, 11 or you need to achieve this effects, or you want to have the 12 dose that is going to result in achieving that which you 13 want to achieve.

14 So, risk then has a new dimension to it, or maybe

[J')

15 16 even multiple dimensions to it, in trying to balance off the applications and the activities.

17 So, the questions which you get asked, which are 18 sort of follow up questions. What can happen? How like is 19 it? And what are the consequences? Have much more 20 complicated answers because they have to be answered in the 21 context of systems which you do not insist are the model as 22 well.

23 And systems for which the answer to the question 24 may even have vastly different answers depending on who you 25 ask that question of because if it is the patient and it's

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l 83 i 1 availability and it's the chose between one form of risk and 2- killing this thing which is killing me or another form, 3 there's going to be a vastly different perspective on how 4 far you might be willing to go in order to try to achieve i

5 killing that thing which is killing me then you would in a

! 6 different context.

i 7 So, it was a very different application from that 8 which we deal with. We're dealing with environmental l-9 radioactivity or decommissioned criteria or issues 10 associated with releasing sites or releasing material or 11 even -- back to the medical community -- how we deal with 12 routine control in the labs and in the practice. And what 13 we start to worry about when we drop the syringes and e'.er i

14 things like that. So, we have a whole variety of as,c__.

r~s i'

15 That has overall background in terms of some of the things 16 that we're struggling with in risk.

l l

17 The Commission's challenged us to look at that 18 from that perspective. Yes, there is a lot of data around l

19 there. How many times particular kinds of events happen.

t l 20 And some data associated with how successful or unsuccessful 21 regulations have been in trying to prevent certain 22 undesirable outcomes.

! 23 If you go back 10 years or so ago the Agency was, t

24 in fact, collecting data which gave information associated 25 with events in some of the diagnostic areas. The Agency 1

1

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l 84 1 concluded that there wasn't a lot of benefit to getting that 2 kind of information. We were seeing lots of things. They 3' didn't.have particular things where it appeared that a

! 4 regulation could have any value that was associated with it.

5 And, in fact, we haven't had a reporting of that kind of l 6- event since '92, '93 type of time frame.

7 On the other side of the equation you still have 8 continued reporting of the higher events in terms of dose 9 differences in the therapy arena and some comparisons have 10 been done with that associated with whether or not the l

11 quality management program had mentioned in California 12 hadn't adopted it. History may, in fact, prove that l

13- California was right.

14 But what it said when we looked at that data is

( 15 there were two or three things when you looked at the events

-16 that seem to always still be there as contributors. And so-17 that's why you have the proposal now in terms of what 18 remains.

l 19 .Make sure that you have the right patient. Make {

20 sure that that which has been written down actually got 21 translated correctly into the machine.

22- Make sure that you haven't gotten yourself trapped !

L 23 in European time versus US time, day, week, month, month, l l

l- 24 day, year sorts of things. Reversing a couple of those 25 contributes to some interesting things. Did you mean micro l

l l

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85 1 or milli? It wasn't written down real clearly, that 31 is a

( ) 2 92 right there. Some of those sorts of things keep cropping 3 up when you look to the data. And so what we've attempted 4 to do here is to try and focus with this proposal on some of 5 those activities as part of the proposal and get away from a 6 great deal of the other prescriptiveness in the -- review 7 which, quite frankly, our retrospective analysis, that 8 didn't help much at all in terms of having any benefit.

9 Several of you mentioned earlier that there are 10 always costs associated with regulations, what are the 11 benefits associated with it? And the answer is that's an l 12 experiment in that arena which appears that there wasn't a l 13 lot of benefit for a large number of those kinds of 14 activities.

I 15

[/

%. Is there enough data around to be able to say that 16 those particular regulation in fact changed the rate of this 17 administration or medically that means we would be using the 18 teacher. Difficult to say because of the statistics of 19 small numbers. The average number of events was in the 30s 20 if you go back six, seven years ago. The average number of 21 the event is now in the low 20s. With the statistical power 22 of that we cannot say whether that's a trend or not.

~23 We had a time about two years ago where we went 24 through about six months with no event. And everyone's 25- going, "We have finally ueen the data." Unfortunately, it ANN RILEY & ASSOCIATES, LTD.

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86 1 was the week right after that where we had four show up.

() 2 So, those sorts of statistics may be kind of 3 difficult to draw long term trends for this particular 4~ process. But that's at least a partial answer back to some t'

i 5 of the suggestions. Very good comments about, "Is there 6 data?" Yes, there is some data. "Can you give us a clear 1

7 answer?" No, I can't necessarily.

8 "Can it give us some clues?" Yes, I think it can.

9 We have attempted to reflect some of those in the kinds of 10 requirements that we made in the proposed rule.

11 "Is diagnostic low?" W t, if I'm looking at it 12 from the context of the other hat that I 1: ave to wear in 13 dealing with EPA, no, not at all. Am I dealing with it in 14 the context of the other risk that you might otherwise run

() 15 into in a comparative, relative sense in diagnosing the 16 difficulty that you have or in treating that, then the 17 answer is probably yes, significantly less than some of the 18 other possibly more evasive mechanisms that you would 19 otherwise have to use to figure out exactly what's going on 20 in-the system.

21 "Is therapy always a high risk?" Well, again, I'm

.22 not sure what the answer to that question is. Certainly, if 23 I were to -- from a radiation standpoint, yeah, that's some 24 - of the highest doses that we ever deal with around here.

25 We're used to dealing with very low doses. , On the other i

l

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87 1 hand, if I'm looking at it from a relative standpoint, it's 2 risk may be less lower compared to some of the chemical 3 agents or the surgical intervention agents that would 4 otherwise have to be used.

5 What's the base line and is that base line, in 6 fact, something that you can even establish for any period 7 of time? I'm posing these as questions because I quite- l 8 frankly don't have a good answer. I'm not sure whether we !

9 can generate a good answer. Overall. But these are the 10 questions I think we need to continue to face and to look 11 at. And then.to use that information to try and calibrate 12 the extent to which we have laid out the regulations and the 13 requirements that we have in place.

14 And with that as an introduction from some of the

() 15 things that are going on in the Agency, I'll turn to Chip.

16 MR. CAMERON: Let's go to Bob for his 17 presentation. And then let's use that as a springboard for 18 discussion.

19 And David Nichols is going to be passing out some 20 copies of Bob's presentation so we'll give him a chance to 21 get those out.

22 And I think during our discussion we'll also be 23 going back to Don to -- then ask harassment. That's what 24' Don whispered up here and that's basically what I had in 25 mind,.but I wasn't going to say that. But to ask him about

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88 1

some of the ongoing-activities that the Agency's engaging in 2 that might be trying to answer some of these difficult 3 questions. Some of the challenges that are evident from 4 Don's presentation.

5- DR LULL: I'm Bob Lull and I'd like each of you 6 to take this document that David is handing out because I'm ,

7 going actually to be following from this document. We did 8 no create' slides or overheads in the short period of time 9f that we had before this meeting.

10 But this document is one that has been circulated 11 and studied and evaluated by the Society of Nuclear Medicine 12 and the American College of Nuclear Physicians. And relates 13 their summary of feelings about risk and relative risk and i 14 the important role that risk analysis should play in the l 1

15 drafting of regulations to control this.

- 11 6 And I'm going to read for you from the regular :

17 summary and then I want to go through and highlight some 18 portions of this document. I don't want this to be 19 something that just kind of flashes up on the screen and 20 then disappears from your life.

21 We've all been through lots of meetings where we 22 end up hearing the presentation, what is said, and then it 23 goes away and that's kind of a past part of your life that 24 never-comes back again.

25 I want you to really kind of focus on this. Take ANN RILFY & ASSOCIATES, LTD.

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89 1

this opportunity now to try and focus on the document and 2

f--

(]g not any -- the pointe that we're trying to make because I 3

think they're very important points that if taken to heart 4 will have a real inpact on the outcome of this draft of new 5 regulation. And I think that they'd play a very important 6

role for trying t o get it right and get it appropriate.

7 Some of this kind of I'll read from the " Executive 8 Summary" for a moment:

9

" Nuclear Medicine has been the subject of 10 regulatory scrutiny since it first entered 11 wide-spread clinical use in the 1950s."

12 Of course, nuclear medicine started -- we just 13 celebrated our 100th year two years ago of the discovery of 14 artiticial radioactivity in 1896. But clinical, modern-day

N 15 nuclear medicine really dates back to the late '50s and (d 16 early '50s.

17 "The NRC has steadily increased its 18 involvement in the regulation of Nuclear 19 Medicine even though there hasn't been 20 really much change in the basic nature of 21 the radioactivity that they use."

22 I talk here about.the number of diagnostic nuclear 23 medicine procedures that are in the millions, depending on 24 whether one includes the in vitro techniques or not and the

.25- 60-70,000 therapeutic nuclear medicine procedures.

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90 1

I would point out the distinction here that the 2

fx nuclear medicine and therapeutic procedures are distinct

(' ')

3 from radiation oncology, which uses sealed sources. And in 4 nuclear medicine we're talking only about unsealed 5 radioactive sources.

6 This is an issue in that many of tue statistics on 7

risk that the NRC has been using and coding mix together 8 radiation oncology incidents and events with nuclear 9 medicine incidents and events and thereby dilutes or 10 increases the relative potential risk assessment for nuclear 11 medicine in an unfair manner since those should not be mixes 12 and need to be separate and, indeed, its distressing to me 13 and many others in the Society of Nuclear Medicine and 14 American College of Nuclear Physicians that this continues

(~N 15 to be the case, that events that occur in the medical O 16 practice of radiation oncology are mixed in as -- lumped 17 together with the events in the nuclear medicine 18 therapeutics. And that should not be the case. Those need 19 to be separated and distinguished. l 1

20 The second paragraph of the " Executive Summary" l

l 21 talks about NRC regulating nuclear medicine properly and 22 talks about the relative radiation dose and we'll emphasize 23 this again when I get into some of the body of this 24 document, that the average dose for a diagnostic nuclear 25 medicine procedure is 440 milligrams effective dose f3 ANN RILEY & ASSOCIATES, LTD.

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91 1 equivalent, which is really equivalent to somewhere in the 2 midrange of the normal annual background radiation in this 3 country. We're talking about a very low level of radiation 4 exposure and associated risk, if any.

5 Now, there's a detailed discussion of cost 6 regulation and subsequent impact. And there's some folks 7 here I want to reference and read this part here in the 8 " Executive Summary."

9 "Because any review of regulation and its 10 impact on the regulated community must 11 include a discussion of the negative impact :

12 of cost on morbidity and mortality."

13 In other words, we're not talking about the risks 14 that you're preventing by action or the risks that may occur

() 15 16 through inaction, but you have to look at the risks that you create by using resources for actions that could be used in 17 other places.

18 Because resources, as we're learning more and more 19 in a managed care medical environment, are limited. And 20 there aren't unlimited resources for things. And we need to 21 use -- and we need to look at risk not only in terms of 22 the -- the focus and the topic that's being focussed on but 23 also in terms of what hold may be left in some other aspect 24 of the lives of our country by using resources that could be 25 targeted at greater needs then on something that is 4

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92 1 essentially a very low risk activity like diagnostic and !

[ 2 therapeutic nuclear medicine.

(

i 3 Well, we recommend some books here and some l I

4 readings. Supreme Court Justice Breyer's book, Breaking the 5 Vicious Cycle Toward Effective Risk Reculation, I think is 1 6 something that's kind of must read.

{

7 "The exact cost of NRC regulation of 8

byproduct material in medicine is not very 9 well defined."

10 It would be nice to have a better handle on what 11 the costs of regulation are because there are significant 12 costs that will correlate when properly defined with 13 mortality and morbidity that could be prevented in other 14 arenas.

() 15 "It is also clear, from the National Academy 16 of Science Institute of Medicine report that 17 the NRC regulations have no positive impact 18 on mortality and morbidity."

19 That is all the regulations of nuclear medicine, 20 according to this very detailed study report have had no l 21 demonstrable impact on mortality and morbidity.

22 We also recommend reading Bernie Cohen's text. It 23 says that pages from his text are attached but they're not.

24 But the concepts are included in the body of this document 25 that you've just been handed.

I l

[

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93 1 Well, we think that the NRCs approach to a risk

( 2 based regulation creation and review is an important one,

}

3 but we feel that the NRC should formulate its regulations 4 based on actual risk and not perceived risks of nuclear 5 medicine and other medical uses of radioactive material, 6 byproduct materials, that are under the NRC's purview.

7 So. I'd like to hand out -- talking to some 8 specific points contained in this document so that it's not 9 just a pile of paper there.

10 First of all, let's turn here to the first page.

11 If everyone would follow through with me here. The 12 " Framework for the Regulation of Nuclear Medicine." We have 13 an introduction that explaine what the two major 14 professional organizations for nuclear medicine are about,

[)

V 15 the American College of Nuclear Physicians and the Society 16 of Nuclear medicine.

17 And I won't go into more detail about that other 18 than that they represent the individual who have a concern 19 about the rules and regulations that you are discussing in 20 these meetings and how they will be applied to patients that 21 they care for.

22 We have a very good section here on the history of 23 nuclear medicine. And I advice you to look at this. It s 24 how in 1946 the first thyroid cancer patient had successful 25 treatments showing the potential significant role of

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94 1 radioisotopes in the therapy of very specific diseases such 2 as thyroid cancer and how, later, the treatment of 3

thyroidtoxitosis (phonetic) became a significant part of the 4 material describing how nuclear medicine has evolved to 5 where we now do over 100 nuclear medicine imagine procedures J 6

that provide unique information about the function of organs 7

within the body and that these are done with a relatively 8 small number of radioactive isotopes that are tagged to an 9 ever larger number of nonradioactive carriers.

10 Now, the section B on page two -- let me turn to 11 page two -- starts a history and has a succinct history of 12 the regulation of nuclear medicine from the Atomic Energy 13 Act authorization for the regulation of reactor-generated 14 radioactive byproduct materials and emphasizing that the NRC 15 does not regulate, accelerate or produce radioisotopes. So

(-~}

16 that there is a large body of radioactive materials that do 17 not come under the purview of NRC regulations, but rather 18 are regulated by the states.

19 It describes in some detail and gives you some 20 historical points which I'm not going to go into in much

21 greater detail here.

22 I'd just like to point out that on page three we 23 see that in 1976 there was another example here of the NRC 24 confusing nuclear medicine and radiation oncology and 25 applying regulations based on incidents that occurred in r~' ANN RILEY & ASSOCIATES, LTD.

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95 1 radiation oncology to nuclear medicine.

2- This is something that continues on and I think 3

that even some of the statistics that were spoken by Don 4

Cool included a mixture of nuclear medicine and radiation 5 oncology events. To get a clear picture of nuclear medicine 6 those need to be distinguished.

7 On page four of the document that you have before 8

you I would like to emphasize that the paragraph that says:

9 "Thus, it is clear that the language of the 10 Medical Policy Statements states that the 11 NRC would regulate patient safety only when 12 justified by the risk but yes over the last 13 20 years the NRC has been decreasing its 14 regulation when there has been no

) 15. demonstrable increase or change in risks.

16 And the risks have remained very, very low."

17 We need to have more -- look at the relative risks 18 of nuclear medicine in terms of the regulatory responses 19 -here.

-20 We note that he -- in 1994 when the NRC, in 21 response to the unhappiness that our organizations have 22 expressed over the increasing regulations in the_ face of low 23 and unchanging risks that the NRC Commission contracted the 24 National Academy of Science as its Institute of Medicine to 25 review its regulatory program and that final report, as fs. ANN RILEY & ASSOCIATES, LTD.

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96 1

described on page five of the handout, was released in March 4

s 2 of 1996. And I'll leave you to read that.

\

Basically the report stated that the risks from 3

4 nuclear medicine, which the National Academy of Sciences 5

looked at and evaluated were minuscule and that the 4

6 regulations had basically outlived their original purpose 7

and that the regulations did not necessarily relate to the l

8 risk.and that a whole new view of this regulatory 9 environment needed to be taken.

10 The Society totally agreed with this, but I 4

11 believe portions of the report had been rejected by the ,

. 12 Commission.

. 13 Then to push forward here to page eight and i

14 emphasize to you here we start describing nuclear medicine, j ()

\j 15 It gives you a greater description of what we do and also

16 how people are currently being trained for nuclear medicine 1

17 and what the requirements of training programs are in terms 4

18 of education and physics, radiopharmacy, radiation biology, c 19 patient evaluation, radionuclide therapy and diagnostic 20

. studies and the board certifications that are available.

21 It doesn't describe in great detail that occurs l 22 for other specialties, such as the diagnostic radiology 23 residents who also are being trained within our nuclear 24 medicine facilities and provide a very large amount of the 25 nuclear medicine clinical care that occurs out in the real i

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97 l 1 clinical environment.

L 2 on page nine we have a section that describes 3 diagnostic nuclear medicine and section B that talks about 4 the risks associated with diagnostic nuclear medicine. And 5

I would like to quote from the last part of that paragraph 6 about risk:

7 "In fact, it appears that there has been only 8

one radiation-induced death from a nuclear 9 medicine error since 1936, when the i 10 specialty began. And that specifically, 11 about 35 to 40 years ago a patient appears l

l 12 to have died from liver failure due to the 13 fact that the patient was administered gold-l 14 198-colloid at 1000 times the intended O

\j 15 dose."

16 I don't think there is any other human activity, 17 and there's certainly no activity in health care, which can 18 claim that they've only been associated with one death in 19 the entire history of that activity. This is, on the face 20 of it, extremely low risk.

21 And so I think it's safe that one can agree with 22 the conclusion at page 10 here at the top:

23 "Because of the attendant low radiation l l

24 absorbed doses, Nuclear Medicine diagnostic 25 materials have little risk."

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l-98 l

1 Again, we emphasize the average dose.is 440

(( ) 2 milligrams radiation dose and patients on diagnostic --

! 3 studies.

l' 4 And table one on page 10, continued on the next 5 page, gives you some comparison radiation exposure rates

{

6 starting with a chest X-ray at 20 milligrams and going all 7 the way up to doses that actually can produce morbidity and 8 mortality just to give you a relative perspective on the 9 radiation average dose in a nuclear medicine diagnostic 10 procedure.

11 Now, on page 11 we now turn to therapeutic nuclear 12 medicine where we have about 60-70,000 procedures performed 13 per year.

14 Therapeutic nuclear medicine is primarily utilized

() 15 for treating thyroid cancer, patients with hyperthyroidism, 16 , usually to due Grave's disease or multinodular toxic 17 goiters.

18 Also is used for relief of pain in patients with 19 sever bone metastases. There are other applications that 20 - are being utilized that aren't as routinely used as the ones 21 I just mentioned.

22 All of these do result in significant higher doses 23 to the patient, by intent, but still, our low risk to the 24 patients in that even with therapeutic _ applications of 25 nuclear medicine there have been no documented deaths due to

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l 99 l 1 this activity.

T 2 It's also considered to be very low risk for the (O

3 public and for the workers.

And all of that is described 4 under paragraph D.

5 On page 11 we also make some distinctions about 6

nuclear pharmacy and emphasizing that nuclear pharmacy 7

practice is controlled and regulated by the states and by 8 the State Boards of Pharmacy. And distinguishing between 9 the compounding that occurs within a nuclear medicine i 10 department and that which happens to have been a centralized 11 nuclear pharmacy or radiopharmacy which also is regulated 12 predominantly by state activity.

13 On page 12 just to point again to make that 14 nuclear medicine is distinct from radiation oncology and i l

1

(

~~/

) 15 that even therapeutic uses of radioisotopes in nuclear 16 medicine and any events associated with those should not be 17 lumped together with sealed sources and events in radiation 18 oncology. If you want to get a true picture of the relative 19 risks for nuclear medicine section procedures.

20 Now, in section four on page 12 we arrive into a 21 discussion of the concept of comparative risk. Now, risk as 22 Don had mentioned or not, isolated and you need to look at 23 things in comparison.

24 We quote here of the speech that was given by Dr.

25 Gail de Planque, a former NRC Comic.issioner, on the 13th of ANN RILEY & ASSOCIATES, LTD.

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100 1 October to the National Academy of Science's Institute of

<- 2 Medicine group reviewing NRC regulations of nuclear I

3 medicine.

4 And I think that there's very useful information 5 there which I will only highlight some aspects of.

6 She ended up giving a speech about comparative 7 risks to help put in context how low the real risk for 8

nuclear medicine procedures are, pointing out that smoking a 9 pack of cigarettes, you know, fines that a death from a 10 related cause of about 28 percent of smokers. So, people 11 who smoke a pack a day increase their risk of dying from 12 related thing about 28 percent. Motorcyclists deaths at 11

/ 13 percent. The chance of dying in a motorcycle accident. You 11 drive a car like I did to get here today, I have a 1

( 15 percent. Those of you who flew in by air only had .02

)

16 percent. You kind of do these comparison analysis and as 17 pointed out previously, they can drive you somewhat crazy 18 but they also perform a very valid, relative risk evaluation 19 that helps you put things in perspective.

20 And we think that that's what's very important, is 21 to put things in perspective and see why are we doing so 22 much regulation of something that is of so low risk. And 23 why are we doing all that regulation of something that's a 24 very low risk. And her statements on page 14 where she goes 25 cn to discuss that therapeutic misadministrations of ANN RILEY & ASSOCIATES, LTD.

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22 84 Ib3

101 l 1 byproduct material, she ended up calculating about .6 out of 2

1000 or .0006 percent risk of death from a therapeutic 3 misadministration.

4 While this was stated there again, even Dr. de 5

Planque ended up, you know, confusing by including radiation 6 oncology in her statistics. So, that nuclear medicines risk 7 is actually significant lower then even that because that 8 included radiation oncology events. And therapy with 9 generally much sicker patients then in nuclear medicine. i 10 So, I tend to summarize here that the ACNP and 11- the -- and the Society of Nuclear Medicine feel that in

~2 1

order to formulate properly a risk based policy that it's 1 1

13 important that the NRC examine the risk of nuclear medicine 14 as they compare, really, to other medical modalities and

() 15_

16 also,every day risks that people are willing to assume for the general-public.

4 17 Now, they also ought to look at things that occur 18 in medicine that have some -- where there's been an 19 ' intent -- a definite intent not to regulate these events in 20 nuclear medicine.

Why nuclear medicine, the least risky of

'21 all the health care enterprises, should be so heavily 22 _ regulated whereas so many other -- practice of medicine have

. 23 very little regulation and seem to be doing just fine is a l 24 ' conundrum that needs further explanation if we're going to

-25 continue that degree of regulation.

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102

1. Page 15, where we talk about nuclear medicine 2

b versus other medical modalities, do you see that there's a

\~ I 3 table two associated with that. It relates to nuclear 4

medicine, it related to risks associated with various X-ray 5 procedures and also it shows that the Radiopharmaceuticals 6 have orders of magnitude lower than those associated with 7

' regular drug administration, such as drugs like penicillin, 8- heparin, even aspirin carries significant greater risk than 9 M t diagnostic administration of any radiopharmaceutical.

10 And in terms of the documented' potential side effects.

11 We also talked about nuclear-medicine versus every 12 day risks assumed by the. general public. Let me give you a 13 number of a usual standard set of tables here. Basically, 14 our risks are so low that even comparing'them to the list of 15- normal' activities that are generally accepted and acceptable 16 to the public shows that we are extremely low compared to 17 'even these normal human activities. And that's table five.

18 Table three shows you the list of death in sports.

19 Table four shows you the commonplace, acceptable risks of '

20 death by non-cancerous risks due to a number of activities.

21 And table ~five shows you the occupational risks of death on >

22 different kinds of occupations. You've probably seen some 23 of these things in the past, but it's useful to have this 24 available. Remember that compared to all of these, nuclear -

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103 1

shown no deaths except maybe that one case of liver failure

(-~ 2 from a misadministration 3

And so we -- in some way we take the NRC at its 4 word that it's going to actually look at risk based 5 regulatory past approach and in view of this and the minimal 6 risk that's posed by nuclear medicine, ACNP and SNM believe 7 that the regulatory burden imposed by the NRC on nuclear 8 medicine and also by states on nuclear medicine and 9 basically address the following questions which are 10 contained on page 22, the last page of your hand out. And 11 that is:

12 "What is the problem sought to be solved or 13 prevented?"

14 In other words, you need to be real clear about 15 what is -- what is the problem? What is the risk that

[v) 16 you're trying to address with these regulations and is this 17 a significant risk? How high is that risk? How big is that 18 risk relative to the risks that people have in general in 19 their lives and that other agencies decide to or not to 20 address by regulatory response.

21 " Number two. Is there a voluntary standard 22 that successfully can address the issue 23 that's consistent with the final policy 24 statement?"

25 In other words, are there other ways where other gg ANN RILEY & ASSOCIATES, LTD.

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i 104 1_

than NRC regulations where you can end up accomplishing the

-2' same goal, or whether that.same goal has already been 3 accomplished.

4 I think there's a large movement to try to 5 minimize intrusive federal regulations, regulations on a i 1

6 federal level if you don't need it. And I think this is the 7

t.< ample where, carefully looking at what's already in place 8 available within the states or within professional I 9

organizations, you.know, we'll end up serving many of the' 10 purposes that regulations have attempted to do in the past.

11 -But it's just'superfluo'us.

12 "Also, is there another regulator that has a 13 mandate already?"

14 There are the state organizations that regulate

() 15 things. There are a number of other regulators of health 16 care, such as Joint Commission on Hospital accreditation 17 that had significant regulatory control.

18 The standards of practice from our professional 19 organizations are_ factors which also serve to limit and

20. maintain low risk. And particularly I think that's

21. something which is an inherently a low risk activity like 22 nuclear-medicine. !

23_ 'And finally if you look at what's the cost 24 !

benefit: "What is the least costly and least restrictive 25 way to genuinely solve the problem?

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We think that after the NRC looks at these questions in context of the proven low risk and the actual 2

)

3 real risks associated with nuclear medicine, not just the 4 perceived potential risk, that they will find opportunities 5 to withdraw much of the regulatory force that is being 6 brought to bear upon the practice of nuclear medicine.

7

, In that case, I've taken you through the document.

8 Please hang onto it. This represents some organization of 9 the Society of Nuclear Medicine and the American College of L

10 Physicians' view on risk assessment and the diagnosis and 11 therapeutic applications of radioisotopes. Thank you.

12 MR. CAMERON: Okay. Thanks very much, Bob, for 13 that overview. It raises some intriguing questions and I 14 think at some point we need to get into the issue of what (v) 15 are the implications for the provisions of the proposed 16 rule.

17 In other words, is the data in at least for 18 nuclear medicine? You made a distinction between nuclear 19 medicine and radiation oncology. Is the data in and, if so, 20 what should we -- what should we do with that in terms of 21 the provisions -- some of the provisions in the proposed 22 rule? '

23 And I guess I would just open it up now for 24 discussion of -- on some of the provocative information that J

25 Bob presented and also some of the challenges that Don l l

l l

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106 1 identified, r~' 2 MR. BROWN: First of all, let me thank Bob for

'(

3 that presentation -- government relations board -- for 4

1 putting thr.t together. I think it does a really good job of -

5 putting the risk involved with diagnostic nuclear medicine 6 really in perspective and really points out how low risk it

, 7 really is.

8 I do want to raise a question. I was a little 9 disappointed to see that the risk -- the work on the risk 10 review group was not included in the Part 35 and their l

11 recommendation is coming sometime later this fall.

12 What is your plan? I mean, depending on what they 13 recommend how can you go back and -- I mean, I know you can 14 change it before the final, but we were hoping you'd correct

(~N 15 their recommendations and how their recommendations would

!.(ms) ~

l 16 impact the proposal. !

l

, 17 'MR. CAMERON: And Don, can you explain to '

18 everybody what Roy is referring to in case they don't know?

19 DR. COOL: Okay. I'll try to do that and then 20 I'll attempt to answer your question.

p 21 As a separate initiative, which actually stamped

}

22 out another one of the strategic assessment direction j 23 setting issues, I have asked my staff to take a look at the 24 risks posed by the various uses of byproduct material, not i 25 just medicine, which are under the jurisdiction of the m

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107 1 Commission. So, this is in the United States Regulatory

(

U 2 jurisdiction, Part 3339, by the Department of Internal Uses.

3 A group of NRC and a grievance -- folks have now 4 been engaged in that process for about the last seven months 5 or so at this point, using some contractor assistant and 6 taking a look at the various systems to use their lingo.

7 Put that in quotes, if you like. A system might be a 8 radiography and all the things associated with the camera to 9 conduct -- conduct and activity.

10 Various kinds of gauging devices constitute 11 various systems. And certainly medical uses constitute 12 certain kinds of systems and they're not consistent with --

13 excluded from this particular study.

14 We are by Commission production to be providing

() 15 16 the Commission with the technical basis report coming out of that study. And some recommendations to the Commission in 17 terms of directions to proceed, changes which that study 18 would indicate in terms of 10 CFR Parts 30 to 39 at the end 1

19 of this year. '

l

20 That study is to be completed this fall to be

21. provide those recommendations to the Commission.

, 22- One of the things that we did with that, both in 23 terms again of trying to keep the task itself to a 24 manageable activity was to focus upon the uses of the f

25 material in the occupational public exposure contents. I 31 ANN RILEY & ASSOCIATES, LTD. ;

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108 1 kept them out of patient context because that would have

-w 2 opened up an area, u.ique area -- unique to this one l

3 particular part.

4 And part of what we were attempting to do was to 5 put by an analysis which would allow us to look at the 6 various uses of byproduct material and occupational and 7 public exposure and make some recommendations to the 8 Commission on the kinds of forms of licensing and inspection 9 which will be conducted.

10 When we provide those recommendations to the 11 Commission we will certainly need to look at -- I would 12 expect that we would be trying to answer Roy's exact 13 question.

14 Are there implications for the medical rule which

- t'

)

15 will at that point be off of public comment in terms of what 16 should be considered and moving forward for a final 17 approval.

18 If those recommendations are such that we need to 19 suggest to the Commission that there are some fundamental 20 changes, that this would dictate some things which would go 21 beyond that which are already on the table, some changes for 22 sure are already part of this proposal. That would mean

-23 that we would effectively be asking the Commission to stop 24 that present rule and go back to an alternative proposal.

25 One of the things that was mentioned earlier, x ANN RILEY & ASSOCIATES, LTD.

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109 1 whether it should be put in the padding (phonetic) or not is

( ) 2 the simple fact that there are changes that can be made to 3 the proposed rule to the final-rule on the basis of comment.

4 If there are things which go beyond that band, are not 5 directly a outcome of a comment process, that were discussed 6 in the workshops, were part of the written comment record, 7 which is the Agency basis, then we wouldn't' need to 1

8 re-propose. Certainly that is a possibility.

9 I think there is a much greater possibility, 10 without trying to prejudge where that studies going to come 1 11 out.

12 But the initial set of changes that the Staff is J

13 going to suggest to the Commission will be more in the 14 device sealed source in some of the gauging arenas and some

() 15 of the other things that are going to be conducted. We're 16 going to let them in areas such as medical, where there are I 17 a lot of human interactions. I'm not sure where all those !

1 18 will play out at that time if the report is not completed 19' and we will have to see where we are at the end of the year 20 and see at that point what that might or might not suggest 21 to the~ Commission in terms of the Staff in terms of whether 1

22 that process will proceed. ;

23 So, we're in a very dynamic sort of position. In 24 an ideal world, yes, we would have that memory, we would go 25 back and we would take a look at that. The Commission will l

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l 110 1 be given that opportunity. What the Commission will choose

~'

i 2 to do with it is yet to be determined.

(O 3 Roy's is back up and I know --

4 MR. CAMERON: Go ahead, Roy, and then we'll see if 5 Marjorie has a clarification on your description of the l 6 legal situation.

7 MR. BROWN: Yes, just a couple of follow ups. If '

8 they concentrated on a dose to the bones of a patient, is it 9 likely that may change the recommendation for the University 10 of Cincinnati proposal?

11 And second of all, once they make their !

12 recommendations will the public get another crack through 13 the Administrative Procedures Act to review any proposed 14 changes of results on that?

/~

l 5 DR. COOL: The answer to the second one is much '

l 16 easier than the answer to the first. Hidden changes that we 17 suggested the Commission would then go into a standard rule 18 making process, which means that they would approve and 19 develop a rule making plan, there would be a proposed rule

20. developed, there would be public comment on that proposal.

21 MR. BROWN: That would go in a parallel track then 22 as Part 35?

23 DR. COOL: It certainly would for all the things 24 that were not related to medical uses. Again, I don't know 25 1 whether the Commission would want us to make any adjustments

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111 1 with this rule and whether they would tell us to do that in 2 parallel to -- I suspect they might, given some of the other ;

3 actions they've taken.

4 This effort to get a basic revision in place and 5 at least move us back that step in the process.

6 Having answered that in a little more detail I was 7 going to -- can you come back and give me the first one or 8 did I manage to -- l 9 MR. BROWN: Yeah, do you know if your Cincinnati 10 proposal? l 11 DR. COOL: I'm going to guess there's not a lot of 12 chances that that -- that this will change that particular 13 proposal. I can't prejudge it because not all of that 14 analysis is in. But I'm willing to guess right now. It's

() 15 my personal guess that that's not going to have a great 16 impact on that proposal, 17 MR. CAMERON: And let me before Marjorie speaks 18 let's ask Don to clarify. If this study forms the basis for 19 something in the final rule or either a modification goes in 20 the proposed rule or to continue with an aspect of the ;

21 proposed rule as opposed to just confirming things, are you 22 saying that people would get a crack at looking at the 23 methodology, not only the data behind the study, but also 24 the methodology that was used to derive those data?

25 DR. COOL: I could shorten your question, Chip?

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t 112 !

1 MR. CAMERON: Probably.

2 j HDR . COOL: Because I think the question you asked 3 was will the study itself and how we did it be available for i

4 people to scrutinize and the answer would be yes.

5 MR. CAMERON: And there was a little bit more, i 6 Okay. So, he'found his words for me. This may cause a --

7 indeed cause a change -- could cause a change with the 8 schedule on any reciprocal aspects. I guess that's all fair p 9 game then, right? i 10 DR. COOL: If there's a result of this, the !

l 11 Commission wants us to change or modify things of Part 35 1 '

12 that effects this ruling, the obviously all of that will l 13 have to come back and we'll have to do whatever main l 14 proposals we will need to do and make sure it's been subject

()

1 15 to copican (phonetic).

16 Again, sort of answering Roy's question, my 17 personal knowledge is that based upon other decisions that l 18 the Commission has made that they probably would want to 19 have the renditions stay on track and take advantage of the !

l l 20 fact that that process was already well on to gaining

( 21 advantaccs, gaining by the proposed rule. And to move ic 22 parallel L 23 with -- for any other changes or additional modifications.

24 That's based both on the fact that the Commission has 25 usually opted to try and complete those processes where it 1.

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113 1 can be because'you can go on almost further and modify, :

2 modify, modify.

3 And also because the Commission got us into this 4 study in large measure because of it's concern with regards 5 to some of the devices, gauging devices, accountability 6 issues and a number of things related to that and I would 7- . personally guess that they would want us to focus the first 8 rule making efforts that would come out of'that stud in that 9 arena which would take more than six months between December 10 and when this revision we'll give to the Commission.

11L MR. CAMERON: And Marjorie, do you want to add 12 something? l 13 MS. ROTHSCHILD: Yes. All I was going to say was 14 that the question about whether there would have to be

( 15 republication of the proposed rule has not presented to the 16 general counsel and that would have to be considered if, in 17 fact, that issue or set of facts comes to pass. !

i 18 So, we really -- at this point, we are not 19 considering that. And I just wanted to clarify that. And 20 that would be a case obviously on the specific facts at the l 21 time.

22 MR. CAMERON: Okay. Thanks for that 23 clarification, Marjorie.

-24 Let's go to Melissa and then go back over to this 25 side of the table.

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114 1 MS. MARTIN: I would just like a point of 2 clarification. Maybe I'm the only one in the dark.

7 You

> 3 said you have 30 reports of what your significant 4 administrations or at least something that caught your 5 attention at that level.

6 Can you differentiate as to which ones of those 7 were diagnostic and which ones of those were therapeutic so 8 that we've got a break down of which ones -- or nuclear 9 medicine, radiation oncology, how do you -- I just would 10 like to have some kind of information on the break down of 11 those if you could.

12 DR. COOL: You certainly can based on the 13 individual reports and the material that's in the database.

14 I can't, at this moment, give you a break down that tells 15 you that four were teletherapies and three were 16 brachytherapies. But the database is certainly sufficient 17 to allow that kind of break down of those that were reported 18 under the existing requirements.

19 I just can't note do it for you today right off 20 the top of my head. And it's changed over the course of 21 time. You've seen -- as you've seen a raise of the certain 22 kinds of modalities, you've seen a rise in their relative 23 contribution to the net number, 24 MR. CAMERON: Don, that does raise -- Melissa's 25 question, I guess, raises the issue that Bob raised in his ANN RILEY & ASSOCIATES, LTD.

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115 i

1 presentation about the fact that of all misadministrations i 2 being lumped together rather than separating out

'^'

3 misadministrations with nuclear medicine implications from 4 those with radiation oncology.

5 Would you care to respond to how we do use these 6 reports in terms of trying to arrive at risk based 7 decisions? I think you spoke to that earlier. In other 1

8 words, there's data but it isn't sufficient to provide I 9 complete answers but it gives us come hints. And maybe you .

l 10 could talk about those hints. l 11 DR. COOL: I'm going to try to do this quickly 12 because we could spend all afternoon. There are a whole 13 series of uses that this gets put to. Starting with the 14 individual report coming in which gets examined and followed

[~)

N._/

15 up on that particular basis, one of the things that we then 16 try to do is we try to look at it for generic implications.

17 I have a standing group of staffing managers 18 within my division that goes and looks at all of the event 19 reports and all the other activities. This being only one 20 of the pieces of input. And says, "Have you seen others 21 like this?" Was there something underneath it that 22 contributed to it that either we need to send out 23 information, " Watch out, this was a contributor", or in fact 24 we need to consider a change to the regulations as a result 25 of this.

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116 1 So, there are a series of uses that get done. We

()

,m 2 go back and do some retrospective analysis. There was a big 3 review that was conducted back a year or so ago on the 4 things that had been reported related to the quality 5 management rule to try and determine whether or not there 6 was value. This is what I mentioned a little earlier. That 7 there were some underlying themes that keep coming up. When 8 you go back and look at the data, the contributing factors 9 that came out of each of these analysis.

10 They are also all resident in a database, the 11 nuclear materials event database. Medical being only one 12 small subset. You'll find all events related to materials 13 use involve the gauge uses events and all the fuel cycle 14 events and some of the safeguard transportation issues O 15

( ,/ within that database which contains both NRC data and state 16 data.

17 One of the other things we will find sometimes is 18 we've seen one and after we poke around a little bit we 19 discover that if you go looking more broadly you'd find some 20 others and, indeed, you can learn some things about trans.

21 MR. CAMERON: Okay. Thanks, Don. Nikki?

22 MS. HOBSON: Well, I'm kind of going to shift 23 gears. But something kind of really caught my attention on 24 page one of Dr. Lull's report.

25 It seems to me that knowing what the cost of

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f 117 1 regulating the medical uses of isotopes would be a real 2 useful piece of information. And the fact that, at least

. 3 according to Dr. Lull, you don't really know what -- what's 4 spent on regulating medical uses.

5 And I'm wondering, is that -- is that a function 6 of your accounting or budgeting system or is it just that no 7 one has really ever sat down and tried to figure it out?

8 Couldn't we do that?

9 DR. COOL: That's an excellent question for which 10 there is no single excellent answer, which is part of the

,- 11 reason -- in the situation, without trying to justify it.

12 In no one place, at this point, do I think you have the kind 13 of data that would enable you to complete an analysis.

14 Certainly, there are things within the Agency that I

j (_)/

) 15 individuals did in the Agency about staff time, dollars 16 contracted.out, things that are spent in that part of the 17 equation.

18 That's actually the small component. And Dr. Lull 19 also addressed to -- what I think he was referring to which 20 is how much effort, time, did these records otherwise are 21 net generated in the community associated with one way or 22 another with the regulations. And then without justifying 23 it but simply to note that one of the confounding variables 24 that goes along with that is the fact that in one sense you 25 could attribute certain activities to the particular regime.

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118 1 And you could say if you eliminate that particular r~s 2 requirement then that expenditure wouldn't take place.

3 I think you would find -- I'm going to wear a 4 health physics hat and Ed might want to comment from the 5 Health Physics Society perspective -- that some of those 6 might be conducted maybe not in exactly the same arena, in 7 other case for other reasons irrespective simply because it 8 constitutes the good practice regulation protection and 9 other things that go along with that.

10 And what you find has happened over the course of 11 time -- and this happens lots of places, not just here -- is 12 that regu?ation feeds good practice, good practice feeds 13 regulation. And a variety of things go back and forth such 14 that when you then go and try and do the kind of study that

/~h 15 you're referring to and try to tease out what is the exact b

16 cost attributable to the regulation versus that what you 17 might do irrespective because that is the appropriate way to 18 l handle the material, different people will give you '

i 19 different sets of answers with regards to how far industry l l

20 would have taken itself or a particular segment of society 21 would have taken itself in the conduct of the activities.

1 22 And that answer will change over the course of time ;

23 depending on all of these pressures, managed care, and l

24 otherwise that they might not balance it out. l 25 So, it's several pieces to a complicated question.

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119 1 I hope that helps you a little bit.

() 2 MS. HOBSON: Well, can I just pursue it just one U

3 little bit further?

4 Recognizing that all the things that you say are 5

true that, you know, there are people out there doing things 6 at some cost because of the regulations and we can't measure 7 that.

8 Is there a way of measuring the direct 9 expenditures, say, at NRC and then you should be able, I 10 would think, look at least where the agreement stays and who 11 are basically doing what the NRC would otherwise be doing, 12 and calculate at least a ballpark figure or -- it's not just 13 dreaming and wishing on it, right?

14 DR. COOL: The answer is yes.

[ h 1S MR. CAMERON: There is going to be a presentation V

16 on regulatory analysis later this afternoon that may give 17 some of that data. And Cathy may want to say something 18 about it.

19 But I think that I'd like to explore -- anybody 20 else who wants to say something about the cost issue because 21 that could be very pertinent.

22 Cathy, did you want to say anything about the 23 regulatory analysis at this point?

24- MS. HANEY: Let me just say a couple of sentences.

25 What we did is part of the rule making to try to come up

.Q I

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120 1 with an idea of what the cost of the rule of the impacts, f' 2 what's to do with the current regulatory' analysis where we 3 go through each section of the rule and say, "Is this an 4 increase on the licensee? Is it a decrease on the 5 licensee?" And the same thing to NRC. And when we went 6 through and came up with some - a total savings -- and I'll 7 give you some numbers this afternoon -- we did not go back 8 and do a base line that says, you know, "Right now, Part 35 9 costs X." It can be done, but we looked at it more from a 10 standpoint of will this proposed rule reduce or increase the 11 burden on licensees, and we showed a reduction.

12 So, those numbers are available in one form or

13. another to get the impact. And I'll go into some numbers 14 this afternoon.

15 We also have what we call and ONB report that we

(} ,

16 need to do in order to support the rule. Don made mention 17 of it earlier. With ONB what we have to look at is what is 18 the burden on the licensees and NRC for the records and 19 reporting.

20 So, again, we use some certain base line numbers 21 of what the hourly rate of staff is, the number of records 22 that need to be maintained and how much time it needs to 23 maintain each record and to prepare each record. The same 24 thing with reports.

1 25 Both of those documents are in the public domain e-s ANN RILEY & ASSOCIATES, LTD.

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121 1 for comment. And it's something that during review of the l

~ 1 2 rule individuals can look at and say, well, you know, you l 3 think that it would take someone that gets paid $30 an hour 4 is going to complete this report. That's not the case.

5 It's going to be someone that gets paid $100 an hour.

6 Therefore, your estimates are off a factor of three, so 7 you're not saving as much as you think you are. ,

8 So, those things are out in the public for 9 comment.

10 MR. CAMERON: Before we get to E 1 who, I 11 believe, has also a comment on cost, Nikki, what's your idea 12 of why this information would be useful and how it could be 13 used?

14 MS. HOBSON: Well, there are, I mean, off the top l I~N 15- of my head a couple of ways.

b 16 First of all, I found this paragraph really quite 17 intriguing. You know, if you do consider the negative 18 impacts of regulatory costs, you know, if you're spending 19 $12 million, according to this, on regulating an activity 20 that clearly doesn't kill people, you have on the other hand 21 not spent the money on maybe another activity that does kill 22 people.

23 So, I do think that -- that -- you can make a more 24 rational allocation of your resources if you kind of knew 25 what resources you were spending.

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122 1 But second, and more directly connected with the

(~' 2 patient point of view, is regulation as cost to the final D) 3 product that's delivered to the patient. And, you know, a 4 lot of the regulations are great and we need them and we 5 want~them, but if the regulation isn't really serving a 6 useful purpose, but it's costing'the patient more money, !

l 7 then we would oppose it, you know. I mean, it's just sort I i

8 of a self-interested kind of thing from the patient point of 9 view. i 10 MR. CAMERON: Okay. Good points. I guess the 11 first point goes to the point that Bob Lull brought up from 12 the study that if you're spending resources on low risk 13 activities you could be using those resources somewhere i

14 else.

f% 15 David?

i 16 MR. BELK: Yes. I just wanted to sort of comment 17 on the issue of the cost of regulations in cort of a general 18 sense.

19 Speaking for the university -- a community as 20 large as the university, some 130,000 folks state wide, the 21 cost of regulation is significant. However, as was pointed 22 out -- Don pointed out -- to tease the exact cost of 23 regulatory compliance out of the operation -- the 24 operational part of the university, is extraordinarily 25 difficult,'for a number of reasons.

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123 1 Several of them are just almost impossible to f~'s 2 describe where we already have staff programs developed to d

3 address other related issues. If you were to ask, well, 4 specifically in the region safety program on a specific 5 campus, how much does it coast for Part 35? There's 6 essentially almost no way I could think of of doing that.

7 But again, I think it's fairly commonly understood 8 the cost of regulation is significant, particularly to an 9 institution as large as the university.

10 And yes, it does -- the cost of regulation does 11 take away from other functions of the university. Obviously 12 here we're primarily concerned about medical applications 13 and medical services. However, it also impacts the cost of 14 a kid's diploma. I mean, there's no way you can put that (n) 15 under it, you know, how much of a cost for an education.

16 But it's there and it is significant.

17 Due to the autonomy of the different campuses and 18 the way budgets are administered and accounted for, 19 collecting information for this sort of purpose would be 20 extraordinarily difficult although I agree it would be 21 useful. But I'm not exactly sure how we would begin to 22 approach it.

23 MR. CAMERON: Okay. Thank you.

24 I know that we're sort of getting into the --

25 we're going to have a break for lunch here. We do have time ANN RILEY & ASSOCIATES, LTD.

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4 124 1 after we come back to continue to discuss this particular gN 2 topic. But I realize people are probably getting hungry.

3 Why don't we go to Bob for a comment and we'll see 4 where we are then.

5 DR. LULL: I have basically two comments. I'll 6 keep it brief because I'm hungry, too.

7 And by the way, I would like to compliment the 8 NRC, the excellent selection of restaurants they had in the 9 front of the book. That was an example of really very good 10 research.

11 MR. CAMERON: Risk benefit.

12 DR. LULL: Well, actually, I would also point out 13 that actually eating your lunch today is a higher risk than 14 getting the diagnostic nuclear medicine information.

15 MR. CAMERON: For those of you who would rather do

)

16 that.

17 DR. LULL: And it's even higher if you go to lunch 18 with someone who does not know the Heimlich maneuver.

19 Okay. My two comments are this: First of all, 20 what I'd like to hear sometime this afternoon is a 21 continuance of this' discussion and what the NRC has or is i 22 planning to do to develop both the structure and the 23 function that I see is needed.

24 They need a structure that is in place within the 25 organization that has the function that analyzes risk and l

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125 1 acts as a filter. So that if things are being proposed or

r'%s -2 anything that comes up for'a sunshine review should pass (j

q 3 through that filter. And if it doesn't show an adequate

! 4 risk and benefit analysis outcome, then it -- it shouldn't 4

5 go forward.

6 And when we talk about risk I think we're talking 7 about risk of harm.

i 8 Now, I want to introduce the concept of 9 pseudo-risk. You know,-that is things that people talk 10 about as risk, but they really don't produce any harm. Risk 11 is really defined in terms of the harm that it could 12 produce. And unless you have a real harm -- a real harm, i

l 13 then it's maybe a pseudo-risk.

T 14 Things that are like pseudo-risks are, for

(} 15 instance, we heard earlier from someone about the technetium 16 (phonetic) or gallium contaminate in a diaper triggering a 17 landfill monitor. Well, there's no real harm to a 18 technetium or a gallium diaper going into the landfill.

19 That's a pseudo-risk in my definition of pseudo-risk. And 20 we need to distinguish those from real risk.

'21 A diagnostic mis-administration or a medical event 22 of the future, what is the real harm associated with those .

l 23 in terms of actual follow ups and outcomes of the 24 mis-administrations that have occurred diagnostically?

25 This is not a real risk. There's no real harm rx ANN RILEY & ASSOCIATES, LTD.

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126 1

that happens to the patient as a result'of one of those. I i

2 Media reaction to some radiation event or i' 3 announcement is a pseudo-risk. It may impact regulatory )

4 . agencies through congressional reaction to it, but media 5

events are considered oftentimes as risks and they are !

6 certainly real. And they impact us and they drive a lot of i

. 7 what we do.

8 !

But you have to understand that they don't t

9 necessarily produce real harm, except through adverse and ;

10 uncalled real reactions ,that aren't based on real risk and 11 real harms.

12 So those are my two comments about pseudo-risk and '

13 the structures for doing real risk analysis on an ongoing 14 basis within the NRC.

/T 15 MR. CAMERON: Yeah, I think some of our regulators U 16 might have some comments after -- or do you want to make one 17 comment on that right now, Terry?

1 18 MR. FRAZEE: Sure. .Actually, it sort of falls in 19 line with the comments that we've already heard about the 20 cost, the dollars and cents. When we get into dollars and 21 cents, that's where an interesting discussion goes on.

22 But the real -- and the pseudo-risk of contractors 23 in the landfills is a dollars and cents kind of thing, 24 because we do have to respond to the cost of that. It's not 25 directed to the medical community or the patient, but it is l I

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127 1 to.the regulatory agency and certainly to the landfill 2- operator. So there's a cost involved there.

3 But the risk to the plant is, you know, the 4 dollars and cents. Well, let's sort of cut to the chase.

5 When you look at the low-risk modalities used in medicine 6 and'you look at what is the worse thing that could happen tc 7 what were medical -- business administration's now medical 8 defense, if you look at the bottom line, what are the 9 consequences to the patient and -- not in every case, but 10 invariably, almost, no harm to the patient, no long-term 11 consequences are expected.

12 Obviously, in my case, it must be a low risk 13 thing. So why are you bothering? And where there is some 14 sort of an impact on the patient, it's like, "Well, okay,"

()

15 we wiped out his thyroid, buc, hey that's a simple t 16 treatment. Your choice is now having to pop a pill for the 17 rest of your life. But, you.know, no one's dying.

18 So, I think that generally speaking the impact to 19 th'e patient is so, so, so low, why are we bothering?

20 So I tend to agree that, you know, use of 21 ' medicine , hey, we're expending a lot of resources and, 22 therefore, you're talking dollars and cents. But I don't 23 see us focused so much on, well, we've got to calculate the 24 cost, the dollars and cents, because, gee, then we'll be 25 arguing on, "Well, is it greater than a certain amount or ANN RILEY & ASSOCIATES, LTD.

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128 1 more" -- let's look at the patient. Is there a risk to the

() 2 patient? Has there been harm?

3- No?. Well, why are we bothering?

4 MR. CAMERON: Okay. That brings us back to this 5 . issue, again, that we have to sort of remember about whether 6 we're talking about the cost side of the. equation or the 7 risk side, it's what are the implications for the proposed 8 rule and the proposed regulatory that we're achieving here.

9 DR. LULL: I just want to close the loop'on the 10 diaper issue, you know, since -- you know, we're kind of i l

11 down at this end here. You know, the appropriate response 12 to diapers tripping monitors and the cost associated with 13 that and a landfill-is not to have more burdensome 14 regulations on the generator of those diapers, but to do

(,j 15 'something about the monitor at the landfi13 that's picking 16 things that don't create any harm.

17 -They need to be monitoring by isotope, by amount 18- of level of radiation, and not set down to background 19 levels. You know, they need more rational approaches so 20 that their approach to regulating that is based on risk 21 rather than pseudo-risk.

22 MR. CAMERON: Why does this remind of the BRC 23 discussion?

24 Let's take the remaining cards and see if we can 25 finish up here by 1:00, so that we can break for lunch.

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129 1 Let's go to Dave and then over to this side and then over to O 2 Kathy.

V 3 DR. LARSON: I just have one very simple question.

4 I may be the only person that hasn't heard the answer, but 5 doesn't the NRC currently subscribe to the notion that the 6 degree of regulation ought to be related to the degree of 7 risk, or not?

8 MR. CAMERON: Well, the answer was "yes."

9 Do you have any follow-up on that in terms of how l 10 faithfully we're following that?

l 11 DR. LARSON: Well, as I read the proposal, it 12 appears to me that regulations tend to be rather uniform in 13 terms of volume of regulation or effort required in various 14 other areas, such as imaging or therapy, nuclear medicine, G

! ) 15 or radiation oncology. And yet probably all of us would 16 agree that risks are quite different.

l 17 MR. CAMERON: Any response from the NRC at this 18 point? You can wait until after lunch, if you choose.

19 Let's go to Dave on this side.

20 MR. NEBLETT: I think we're looking for positive 21 suggestions to problems. And I suggest to you that you 22 cannot manage or regulate that which you do not measure.

23 And in the areas of your reports, specifically 24 mid-administration, are in terms of percentages of dose.

25 Which does not correlate with risk O ANN RILEY & ASSOCIATES, LTD.

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130 1 These reports should be in terms of risk.

(~~g 2 MR. CAMERON: Okay. Thalf you, David. That's V 3 interesting bit to explore when we come back.

4 Kathy?

5 MS. THOMAS: Are we're already talking about the 6 same thing, because mine relates right to that. We're 7 talking about risk and we get the reports for 8 administrations. But the question is if there's not 9 clinical outcome to that risk, okay, so there is an 10 insignificant risk -- whether it's a pseudo-risk or whatever 11 you call it. But does the NRC look at the clinical outcome 12 and is that where the regulations are derived from? Or are 13 they just saying, "Yes, there's a risk. The patient's been 14 exposed to radiation. Therefore, this area needs to be 15 regulated"?

x. /

16 So my question is are you looking at the final 17 outcome of that risk or are you -- it's just because there's 18 been a mis-administration that there is some perception that 19 there's a need to more heavily regulate that area to make 20 that go away, even though there's not a clinical outcome 21 associated with that?

22 MR. CAMERON: That's a good question. And, also, 23 I'd like to add to it. What are the -- depending on the 24 answer, what are the implications for what we have in the 25 proposed rule?

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131 -

i 1 So I'd like to keep bringing you all back to the

?

()

~

2 proposed rule on this one. I

V j 3 a

Don, do you have anything.-- do you want to say 4 anything on that now? i 1

5 DR. COOL: A very brief response, because I think 6 you would find that history indicates that a number of the !

7 regulations in the past have been driven by the fact that 1

8 there was an exposure. Some of the bigger ones -- l 9 teletherapy and others -- were driven by clinical severe 10 outcomes, severe burns, death -- whatever it was. Some of 11 the other ones, I think you would end up attributing to an 12 exposure to the place which was indirectly related to 13 whether or not there was a long-term clinical follow-up or i 14 intervent on that was needed in the process. And history

() 15 will lead you in both directions.

1 16 MR. CAMERON: Okay. Thanks, Don. )

17 Let's go to Ed Bailey for a final comment before 18 we break for -- to lunch. And I think thiF is a good intro 19 to be examined. And then perhaps we can see if anybody in 20 the audience has anything to say right now. But, go ahead, 21 Ed.

22 MR. BAILEY: When we talk about the risk and the 23 reporting of mis-administrations -- by whatever name you 24 want to call it -- I think those present a problem for 25 agreement states in that if we use the definition similar to

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132 l 1 what we have for radioactive materials for our X-ray fs 2 facilities, every time a film wasn't good it had to be U 3 repeated. That would be a mis-administration.

4 And we get into some real problems of having sort j 5 of an equal enforcement for the same physical agent j 6 attacking the body, if you want to look at it that way.

7 That has always been a problem, I think, with the 8 agreement states looking at. Some of them actually, in l

9 adopting the mis-administration rule, did include X-ray for 10 a while. And then they had to go back and basically take it 11 out, because it is a problem.

12 The other thing, the question about the increased 13 number of landfill alarms and so forth, I think that there 14 is an opportunity for those of us who are regulators -- and (T 15 everybody else, for that matter, in their own arena -- to

%)

16 help educate the landfill operators and the medical waste 17 processors -- or whatever they're called now.

18 We have done that -- or we have tried to do that, 19 particularly with regard to medical waste handlers. Where 20 . we're set up procedures so that, you know, somebody doesn't 21 go out every time the alarm goes off. There are procedures 22 set up, there are requirements on the people that are going 23 to do medical waste processing.

24 We've also tried to do it somewhat with the solid 25 waste facilities. And I think our experience right now has g~% ANN RILEY & ASSOCIATES, LTD.

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l 133 1 been that most of the alarms we're getting right now are not 2 coming from the therapy doses, anyway. They're coming from 3 diagnostic. They're coming from magnesium and they're 4 coming from galvin (phonetic). And those, we're not going 5 to stop, regardless of what the release rate is. '

6 So keeping those kind of thoughts in mind as we

'7 look at the release rates.

8 MR. CAMERON: Okay. Thank you, Ed.

9 David Nichols, you have some comments on this?

10 MR. NICHOLS: David Nichols, American College of 11 Nuclear Physicians and Society of Nuclear Medicine.

12 A couple of issues that I think I'd like to have 13 addressed after lunch, we're talking about some of the 14 processes that have gone into the regs, and in a proposed Is 15 rule the NRC mentioned there.are several documents that they

%s) 16 considered when formulating their risk as far as this 17 propcsed rule.

18 There was one document in there which was a 1993 19 senior internal management review of risk. That document is 20 not available in the public document room, and I think it 21 would be important to make that available to the public, so 22 that they can clearly look at all the documents that have 23 gone into this, as much as Roy mentioned seeing the outcome 24 of the risk review group and their comments.

25 Also, I think a comment on the study ongoing with p)

(_

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134 1 Scientech (phonetic) and some of the questions that that

-(\_/) 2 consulting firm has asked, both license fees and agreement 3 sales. We think that that is a really poor way of gathering 4 data to determine risk, and particularly in light of some of 5 the questions that are there.

6 Also, to answer some of the questions that came up 7 earlier as far as cost: One cost that we are aware of that 8 the nuclear medicine community figures are staggering is the 9 paperwork cost. And the ONB paperwork request, information 10 accrual request that NRC had submitted, those costs were 11 upwards of $130 million just for the paperwork.

12 And that does not go into all of the other 13 associated regulatory costs that are out there, as far as 14 compliance and outside of the paperwork costs.

/n

( ,) 15 Also, on the number of mis-administrations, when l

16 you look at the data pool that NRC has, we find that less 17 than half of those mis-administrations are nuclear medicine 18 -- therapeutic nuclear medicine-related. And out of that 19 data pool, a lot cf those mis-administrations result in no 20 harm to the patient, as was mentioned earlier.

21 So there are very few mis-administrations that 22 have any detrimental effect on the patient that were 23 reported to the NRC, and subsequently reported to the 24 Congress.

25 MR. CAMERON: Okay. Thank you very much, David.

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135 1 A final comment, Dr. Price?

f'} 2 DR. PRICE: Yes, thank you. David Price from San

\d 3 Francisco.

4 I just want to make a comment, because my time may 5 not be available later on. On this risk issue there are a 6 number of numbers that we work with now, the .5 gram 7 initially, the (inaudible) -- is based on estimates of risk 8 that aren't reasonable. The .1 gram is based, I think, on 9 EPA risks of one death in 10,000 -- assuming that the person 10 gets .1 exposure in one year, or get it every year for her 11 whole life. These are not reasonable assumptions.

12 I think a simpler approach to this would be to 13 simply categorize risks and estimate the low, an 14 intermediate, and a high category of risk. One might use,

( )) 15 for example, the HPS 5 gram policy statement level. Below 16 that level, there's no evidence -- excuse me, the linear and 17 threshold model holds.

18 And if one may categorize risks by low, 19 intermediate and high, and said that for low risk incidents 20 or low risk usages, exposures, there is no requirement for 21 paperwork or excessive documentation. For intermediate 22 risk, that there's a certain low level of documentation 23 required. For high risk, much more documentation required.

24 Use this sort of a simple approach and then 25 identify the low, intermediate and high by agreeable

()

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136 1 criteria, that this might simplify a great deal and 2 certainly make my field -- nuclear medicine -- a lot easier I 3 to work with.

4 MR. CAMERON: Thank you for that suggestion, Dr.

1 5 Price.

6 I think we'll want to continue on the same vein. I 7 There are some issues that have been proposed, and I think 8 that's.at least a first suggestion of how a rule might be l 9 altered based on the assessment of risk.

10 I think it's fair to say, also, that I think the :

11 staff has already tried to factor in some of these 12 assessments of risk into what they've done in the proposed 13 rule and let's try to continue on that vein when we come 14 back.

/ 15 Why don't we be back at 2:00? That gives us an 16 hour, which should be sufficient at this point.

17 [Whereupon, at 2:00 p.m., the public meeting was 18 recessed, to reconvene at 3:00 p.m., this same day.]

19 20 21 22 23 24

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137 1 AFTERNOON SESSION I

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O 3 MR. CAMERON: I suggest that we -- I don't want to 4 channel off this discussion that we've been working on, but l 5 let's reevaluate where we are at 3:00. Because at this 1

6 point, we may be here all night.

7 But let's go until 3:00. I put up a simple-minded 8 schematic here, I think, on what we were talking about.

9 This assumes that risk-inform regulation is a good 10 goal. I think that everybody -- it seems like they agree 11 that that's a good goal for the NRC.

12 We get to this point, then: What is low risk?

13 Granted there is some problems with a definition of that.

14 Has it been demonstrated what's been low risk? And, if so, !

1

[') 15 what should be changed in the proposed rule?

N_/

l 16 And a corollary of that, that I want the staff to 17 address, is we've already done some work in this figure. In 18 other words, trying to eliminate the parts of the existing 19 regulatory scheme that we don't think are in the high risk 20 category.

21 If it hasn't been demonstrated, what needs to be 22 done and by whom to generate the necessary data? And this 23 includes this filter issue that Don raised, and that we 24 still owe the group an answer on, Don. In other words, what 25 is high risk benefit or cost benefit? And fold it into our g--)

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138 1 decision making process.

./~s) 2 And just to clean up one detail, the study that

'~

3 David Nichols brought up before lunch -- David isn't here 4 now.

5 Cathy, why don't you tell the rest of the group 6 about the status of that particular study?

7 MS. HANEY: I think that when I stepped out it was 8 right before lunch. Dave brought up a study. It was an 9 internal audit that was done by NRC management of the 10 medical program.

11 I'll be checking this week to find out whether it 12 can be released or not. .

13 The package right now is with our commissioners 14 for -- it's not for a formal vote, but it's just for an okay

['Y 15 to release. I'll ask that the office try to get an answer U

16 by 5:00 tomorrow, so that I can pass it on to everybody or, 17 you know, just put it on the record that it is -- it's at 18 the last point for someone to make a decision on whether it 19 can be released or not.

20 MR. CAMERON: Roy, you have a question on that?

21 MR. BROWN: Yeah. A question Specific to that, 22 the Scientech survey. I guess the question -- the concerns 23 that were had was that looking at the survey itself and the 24 questions and the data you would get from that, it was 25 difficult to make that quantum'ieap, to take that data and s ANN RILEY & ASSOCIATES, LTD.

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139 1 puc it into some kind of risk assessment. It didn't really 2 seem like an appropriate study.

3 MS. MANNING: This is a different report from 4 Scientech. This is a 1993 report.

5 MS. HANEY: This is a different study.

6 MR. CAMERON: And I guess that goes to -- I know 7 some of'you have concern about the Scientech study which was 8

referred to by Don as the regulatory review group, okay, 9 this morning. That's the Scientech study. Scientech is a 10 contractor working for the Commission.

11 And Don addressed, one, what are the implications 12 of that study for the Part 35 rule making. And I think that 13 it is going to be folded in. It sounds to me like some 14 people around the table have problems with the methodology ,

() 15-16 that was used to generate those data that are in there.

Let's go to Ed. Or, Bob, do you have a question 17 about --

18 DR. LULL: Yes -- I'm not sure I can clarify, but 19 I've got a question about it. You say it may be released or 20 it may not be. As far as, NRC doesn't have secret or top '

21 secret categorization. Doesn't the Freedom of Information !

22 Act mean everything's releasable? Can you clarify that?

I 23 MR. CAMERON: No, unfortunately it doesn't. Or I 24 shouldn't say "unfortunately." Who am I to say that?

l 25 DR. LULL: You're a citizen, that's fine. There 1 l

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140 are things that' the government does ought to be available to m

, 1.

-2 the citizens. I mean, that's what the Freedom of

'(}

3 Information Act is about, isn't it?

3 4 MR.-CAMERON: Marjorie, do you want to -- do you 5- want to clarify what's available -- general what's available '

i 6 or what's not?

7 MS. ROTHSCHILD: I-don't deal with the Freedom of

-8 Information Act issues except in our regulations. I believe !

4 1

9 it's Part 2, 10 CFR. I believe that --

)

j 10 MS. CHANEY: It is 10 CFR, Part 2. I

'11 MR. CAMERON: It's 2.790.

l 12 MS. CHANEY: There are some categories of )

. 13 documents that are not releasable. One example is if it i

f 114 = contains' social security numbers. And there's a list of l

\

l 15 .about four or five criteria. )

16 But because this was a document that was generated !

17 under our executive director of operations and it was mailed i 18 to the Commission, we're just going through the formal

]

l 19 administrative steps of can this be released, yes or no. j l

~

20' It's not something that someone at my level can make a 21 decision that it can be released.

22 DR. LULL: Okay. I guess I'm.just really being 23 simplistic. I thought that, you know, when the government 24 operates and creates documents using our tax dollarn to fund 25 the creation of them, that the principle of the Freedom of

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141 1

Information Act was that they might blank out things that 2

are unacceptable to let get out, but that the basic document j 3 is always releasable under that act, unless it's a top 4 secret-something military thing.

5 MR. CAMERON: There's six exemptions, basically, 6

to the Freedom of Information -- to the free release under 7 the Freedom of Information Act. And one of the exemptions, 8 Exemption 5, is for pre-decisional information.

In other

-9 words, information that's being used in a decision-making i

, 10 process that hasn't yet been completed yet. And that can 11 cover a whole lot of materials.

1 12 But it allows the agency to hold back those 1 1

4 t

13 documents. But as a policy matter, the agency can release

+

14 those documents. And I didn't want to spend a whole lot of

) 15 time on this. I just hope that the document that Cathy is 16 talking about is released and then we won't have to worry 17 about whatever the rationale is.

18 Kathy?

19 MS. THOMAS: This is just getting back to what you 20 were going over. Can we step back to the beginning, where 21 you're saying risk-informed regulation is a good goal?

22 Would you mind defining to me what " risk-informed" means to 23 you?

24 MR. CAMERON: I think it's probably appropriate to 25 turn to Don, actually. I I

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B 142 1 What does " risk-informed regulation" mean to the 2 ~ Commission?

3 DR. COOL: How long do you have?

j 4 MR. CAMERON: A very short answer to that.

'5 DR. COOL: _There's.actually a very short answer to 6 that. The Commission.has been developing a lengthy report, 7 trying to define some of these terms so there can be 8 consistent usage, because different people do have some i

9 different views.

10' I'm not sure that the Commission has actually 11 finalized those definitions. So what I would tell you is in 12 some sense a risk-informed -- a risk-based document would be i

13 a document where whatever was being developed -- the 14 regulations, the guidance, the criteria for review and

() 15- approval -- was strictly, linearally based on a mathematical l 16 analysis related to a quantitative calculation of risk.

17 There's no_ deviation. You write down the equation and 18 whatever the equation gives you, is the answer and specifies 19 a given action.

20 A risk-informed approach is to take risk insights 21 generated by maybe a variety of activities, including the 22 things that we've talked about here, as well as quantitative 23 data, and use that to inform the developer of the particular 24 ' regulatory product.

25. The difference being that there is not an i

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143 4

1 automatic specification correlation, but simply that there f~'} 2 should be a relationship between the two and the risk data v

3 used as part of the process to develop and set the criteria.

4 MS. THOMAS: So if you can't demonstrate a risk 5 associated with whatever the action is, then we don't need 6 to worry about it?

7 MR. CAMERON: What's literally hands-on.

, You know 8 -- I mean, what is " love"?

9 MS. THOMAS: Right.

10 MR. CAMERON: Okay? That can be obviously in the 11 mind of the beholder. What does that mean in terms of -- we 12 were talking about actual or perceive. You get into any i 13 sort of balancing of costs -- in other words, is there a 14 risk that is not worth the additional cost of a regulation?

15 Don's explanation, I think, is probably the best. 1 16 These type of issues have not really been defined as part of ;

17 a risk-informed approach. And that's fair game for all of 18 you to say what should be risk-informed approach and terms, 19 and we've been dealing with that. What should be a 20 risk-informed approach in terms of Part 35?

21 Let me go to Ed and then to Roy, and then we'll 22 come back over here. l l

23 MR. BAILEY: As we broke for lunch, I remembered 1 24 from a discussion about a risk base and then we got into 25 essentially saying cost could also be a risk. But I think

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144 1 in general we've been talking about health risk.

2 But if we go to cost as a risk, then I would 3 suggest-that we would have to look at the amount of 4 regulation'that goes on in medicine compared to the amount 5 of regulation that goes on in generally-licensed gauges.

6

~I think there could be a tremendous differential 7 in actual cost from the inadvertent melting of 8 generally-licensed gauges. And yet we don't seem to want to

, l 3

9 go in that direction, to where we're regulating them, 4

10 although we know that there have been millions and millions 11 and millions of dollars that have resulted -- of costs that 1 1

12- have resulted from the melting of these and the attendant

13 loss of work by the people at the still foundries.

i 14 So if you try to balance medical and 15

( generally-licensed gauges, there's a whole lot more 16 regulation in the medical.

4 17 MR. CAMERON: And you're using cost in the terms 18 of regulating to prevent --

19 MR. BAILEY: Economic gain.

20 MR. CAMERO!~ : -- the economic end. And then that 21 gets into the < thole --

22 MR. BAILEY: Yeah. I don't know that -- I think 23 as we're talking here, we're talking solely about risk in 24 terms of health effects.

25 And we have not gotten too much into the cost, ANN RILEY & ASSOCIATES, LTD.

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l 145 1 although we did, right before the break, begin to talk about 1

[%-J) 2 'the cost of doing this, or the cost of funding the record i 3 keeping of something and what you can't spend that money on 4 as a result.

l 5 I just happen to have a document from the l

6 University of Arizona that, for instance, said that they're 7 going to spend a half a million dollars building a facility 8 to store low-level waste. And they would rather not spend 9 that half a million dollars doing that. They'd rather spend 10 that half a million dollars in research or funding research. l 11 So I think the same thing comes here.

12 MR. FRAZEE: Yeah, I think that we don't want to 13 -- you can get real global with these discussions, in terms 14 of what the trade-offs should be. And I think that we fm

(_,) 15 probably have to -- I think there's enough to do possibly 16 just within this one rule, to say that if we identify the 17 low-risk areas and eliminate the money and time that might 18 be spent complying with regulations in low-risk areas, that 19- that money and time could be spent in other higher-risk 20 areas or doing something else.

21 So I think we're back to this: What is a low-risk 22 activity? And I think that, at least from what I gather 23 from what Bob has been saying, is that you think that you 24 have a pretty good handle on what are low-risk activities.

25 I still haven't heard, other than what Dr. Price ANN RILEY & ASSOCIATES, LTD.

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146 1 said today, is where this rule -- if you think that we have

h 2 demonstrated low risk at some point, then what do you throw

[G 3 out of the rule? Okay? Who do you throw out of the 4 proposed rule for a policy statement?

5 And I realize there may be a spectrum of things 6 that you would deal with there.

7 This is what he's been working on.

8 DR. COOL: There's no question of what you propose 9 with the Part 35 is better than the existing Part 35, and 10 certainly down the way from some other descriptive writings 11 and we've clearly gone to more of a conformance base. So I 12 think it's been a very positive move.

13 But we've spent the last couple of years talking 14 about this, three public workshops for the last go-around

((~%) 15 and three this go-around. We have scores of written 16 comments. We've done all we can do to try to justify and 17 try to demonstrate that diagnostic nuclear medicine and 18 nuclear pharmacy is a low-risk operation.

19 We've got the numbers here. You've got the 20 treatise,on low risk in front of you. What are we missing 21 to get to a general license diagnostic nuclear medicine or a 22 two-tier approach that we talked about in Philadelphia and 23 Chicago? What are we missing? What else can we give the 24 Commission to make them take the next step, to say, "Okay.

25 We feel it's safe enough to allow people in diagnostic

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147 1 nuclear medicine a general license, providing you meet 2 certain guidelines and training and experience"?

(

3 MR. CAMERON: Do I have anybody -- I'll ask the 4 staff to address that. And I know that there's a lot of 5 facets to that and that it's difficult to answer.

6 DR. COOL: I wish I could give you a list that

! 7 would tie in and there was a success path. I'm not sure of 8 the latter statement, though. There would seem to be places 9 that are weaker.

10 The first one of those is -- and I think the 11 discussions today have fallen under a similar vein -- all 12 the focus on the patient as the receptor of the risk. And 2

13 the areas that are weaker are dealing with the other two 14 aspects that the Commission has to consider, which is I

() 15 -occupational and other members of the public.

16 Now, the other members of the public may not be a 17 significant factor. And if you're in unit doses, then you 18 may be able to argue successfully, but I don't think that 19 argument has necessarily been put together as crisply as 20 what we've been talking about here earlier with regards to 21 things like emission control, occupational exposure, and 22 otherwise.

23 But when you start to talk about things related to 24 fabrication of labeling, quantities of unsuitable materials, 25 then some of the things, I believe, crawl in which are not f~

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148 1 related to the actual administration to the patient. Would

() 2 3

you give a general license in that aspect, which is less attractive. I 4 And I would suggest to you that if there were a l 5 success path, part of the success path might be trying to 6 define a mechanism which carves out an area which avoids 7 some of the occupational and public steps. And then -- ,

8 because there were some discussions on this. Having carved 9 that out, whether that then is such a small arena that it i

10 doesn't make sense to try and have what would amount to a --

11 potentially a more complicated system of what am I doing, 12 under what structure, and what arrangements, and do I l

13 effectively have to have a license, because of those things 14 that I'm doing, except for a clinical situation, such that

) 15 it does end of being useful?

l 16 Because that was part of the problem that we ran 17 into the first time. Because as a result of those 18 discussions, I'll tell you very frankly, we looked at, "Can 19 you do a general license for certain kinds of aspects?"

20 And we concluded that the nitch created was not of 21 the size that it would really be beneficial in terms of all 22 the other aspects, the administration and the things rP i 23 the university or the clinic would otherwise have to be 24 looking at, because of the way -- and perhaps the data set 25 is wrong. The materials that we used -- such that you end I~'l ANN RILEY & ASSOCIATES, LTD.

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149 i 1 up having a specific license, anyhow, because of other r3 2 things that you were doing. And so it didn't help you that

(# !

3 much, because it created another layer of documents.

4 But that's sort of the weakness. So I don't think 5

the argument's been carved out to really make a case yet.

6 MR. CAMERON: I'd say there's a legitimate 7 question for the NRC to ask. What could Roy or Bob or the 8 rest of the people bring us in terms of risk data that would 9 convince us to take either this type of an approach or make 10 other changes? And we need to identify some other changes, 11 perhaps in a rule.

1 12 And, Bob, why don't you go ahead?

13 DR. LULL: Well, I mean there is data. The data I 14 is out there. We've been measuring radiation doses and

(~N 15 occupational and exposed personnel in medicine for years.

)

%/

16 There's a huge amount of data and it's all negative.

1 17 I mean, it's a real problem. Just as the patient !

18 data is very out there and shows that it's not a problem.

19 You can end up talking about hypothetical and theoretical 20 risk. And I think my general comment is that we could be 21 accused of being real fuzzy in terms of our use of that word l 22 " risk." We're using that word " risk" in about 10 different l 23 times within a matter of space of a minute or two. And 24 we're not being real precise in terms of the use of this.

25 I'm simply concerned that, you know, you set up

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150 1 this straw man potential theoretical risk where you do f~T 2 linear extrapolation from high doses down to low doses, and Y

3 say, well, that's not a definition of risk from radiation.

4 But the fact of the matter is you can end up calculating all S kinds of ridiculous things out of that. We can measure l 6 radiation levels down to very low levels.

7 -I once did -- went through the drill of 8 calculating out how many people in this country 9 theoretically die because they spent eight hours sleeping 10 next to their mate who has potassium 40 that radiates them 11 into a level that we can measure. And it's about five 12 people a year who die in this country.

13 Now, you can say that. But does anybody really 14 believe that?

() 15 I mean these are hypothetical, theoretical risks.

16 We're talking cbout real risk, based on real harms that are ;

17 measurable, and there aren't any in nuclear medicine. I 18 don't know what else you need.

i 19 The data is very clear cut and it's out there.

20 MR. CAMERON: Okay. Thank y.ou, Bob.

21 Melissa? ,

22 MS. MARTIN: I think I'm coming back to the same 23 point. I was -- for point of clarification, if I'm reading 24 the general consensus' of what I'm hearing, is that basically ;

,. 25 the adoption -- the policy of the Commission is that there i ANN RILEY & ASSOCIATES, LTD.

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151 1 is a no tolerance and no risk assumed level. Is that clear?

{() 2 In'other words, or what we're looking for -- what is the i 3 policy to define what is a low risk? Is the definition 4 right now that there's a zero tolerance, period?

5'

! HMR . CAMERON: Don? Cathy? Diane?

, 6 DR. COOL: I guess I'm not quite sure I understand l

7 the question yet. The Commission has certainly been looking i

8 in a direction of being risk-informed. That is, having risk 9 insights and levels of risk in forming the regulatory I'-

10 process.

11 Does that mean that there is a point at which it 12 will walk away from mEterial? I think there, in theory, 13 cortainly is, because there are release criteria for l 14 materials. .There are exemptions for certain kinds of

() 15 materials or quantities of materials that are present.

16- There are materials that can be released to the environment 17 which you construe as a de facto' level. But I'm not sure 18 that that's quite the same as whether the Commission -- and 19 here's where I'm nct quite sure what your reference to zero I 20 tolerance:is. Zero tolerance of what?

2

.1 MS. MARTIN: Okay. I didn't make that clear.

22 What I'm basically following up on, what 23 -information is needed, besides what is already available, to 24 define what is an acceptable, quote, low risk? At which 25 point has that policy been defined? Is it one occurrence in

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152 1 a million cases? Is it one mis-administration of a

() 2 diagnostic study in 10,000 cases? Where is that line being 3 drawn?

4 That's what I'm asking. Is where do you get --

5 who makes the call? Has it been made that there is never --

6 as long as there's one diagnostic mis-administration, is 7- that going to be a reason to have all of these regulations?

8 Or is one mis-administration of a diagnostic isotope in 9 every 10,000 cases acceptable?

10 MR. CAMERON: And, Don, you may explain while 11 you're addressing that, you might also want to talk about 12 how this information typically does get into the decision 13 making processes at the NRC. That's still turf that Bob 14 Lull was talking about. So I think it's all wrapped up 15 together.

16 DR. COOL: I think the answer to that question in I 17 reality is that it's not written down and that the 18 Commission is, in fact, struggling with it.

19 If you look at some of the transcripts of the 20 Commission briefings, some of the considerations on the 21 policy statement, the Commission is -- the Commissioners 22 themselves were asking questions about what kinds of things 23 you would use as the benchmarks for this and at what point 24 would that number translate into an action.

25 So I don't believe the Commission itself has in ANN RILEY & ASSOCIATES, LTD.

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153 1 its mind now a particular number, as it has in the reactor 2 arena, where anything over 10 to the minus 6 means you're (G~)

3 going to take some action.

4 MS. MARTIN: That's what I mean, something like 5 that.

6 DR. COOL: And 10 to the minus 6 would be 7 translated into doses and millicuries, single digits.

8 So be careful about where you use that, because 9 they're not in the same breath. They're not talking about

/

10 risk in an absolute, automatic-related sense. That's where 11 -- that's why the Commission talks about risk-informed.

12 Letting the risk insights guide the process, but not driving 13 to a particular number.

14 Because if you want to go to that arena, the O) t s

15 arguments that ycu've made here probably won't fly at all, 16 because they will be in the face of a larger set of data 17 where it says that other actions have been taken.

18 Let me go to the second question that you asked me 19 to identify. I'm not sure whether I can really j 20 satisfactorily address the two or three times that this has 21 been brought up.

22 But depending upon the process that you're in -- !

23 and at the moment we're in a rule making process. So in the ,

1 24 rule making process there are a number of places where the 1

25 information can come into play. We're generating some here. I l

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154 1 They get reflected, then, in a series of 2 documents. You'll find descriptions of how they got used or 3 what the net result was as part of the statement of 4 considerations. You will find cost data analysis associated 5 with alternatives and options in the relative sense of 6 preparing options for goodness or lack of goodness, as part 7 of the regulatory analysis, which is part of the document.

8 You will find estimate of burden associated with 9 that limited subset of record keeping and reporting, as 10 defined by ON3, as part of the ONB clearance.

11 The data such as the med data gets processed as 12 part of the consideration. And if you're looking for where 13 is it written down that qualified events were done, usually 14 the statement of consideration doesn't get to that level of O 15 detail. We wrote too many reams of paper as it was already.

j 16 But it was underneath some of those analysis.

17 Does that help the question? I'm not sure whether 18 I got back to your point.

19 MR. CAMERON: No, I don't it does, because it's an

20 accurate representation of what goes on in the agency. We 21 do have regulatory analysis guidelines that require 22 identification of certain types of costs and benefits to go 23 into the rule making process.

24 But that's pretty basically, I think, the filter 25 that all of this information goes through, first on a staff

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155 1 level and then ultimately on a commission level.

-x 2 Let me go down to Bill, because I know he has --

3 MR. EHMIG: You've asked if we can make some 4 suggestions.

5 MR. CAMERON: Yes.

6 MR. EHMIG: I'm going to make a suggestion based 7 on a hypothetical case. But let me give you the case.

8 Dr. Lull prescribed a patient.to get 20 9 millicuries of technetium MDP (phonetic) injection for a 10 bone scan.

11 MR. CAMERON: Do you mind being a guinea pig in 12 this?

13 DR. LULL: No , not at all.

14 MR. EHMIG: And either through a pharmacy unit 15 dose or by his own technologist, making up an dispensing and 16 administering the doze, the patient gets 23 millicuries and 17 you have a reportable mis-administration. Which is 18 absolutely ludicrous because if he administers and orders 30 19 millicuries and gets 30 or 29 or 31, there's no issue.

20 Now, you can extrapolate that and say he's already 21 200 millicuries of iodine 131 for metastatic thyroid cancer 22 in the lungs, and he gets 15 percent more. Yes, I would 23 agree that's a serious incident.

24 MR. CAMERON: Yes, I would think so.

25 MR. EHMIG: Not life threatening, but it's

<g -

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156 1 serious.

[~T 2 But I think the issue is you can't take a linear

%)

3 relationship between worse case and innocuous. ;

4 MR. CAMERON: Cathy, do you want to --

5 MS. HANEY: Yes. I guess the example that you 6 gave is in the diagnostic area. That probably would not 7 have triggered a medical event -- or a mis-administration 8 report.

9 And that's where I think we're saying we're not --

10 back in the '80s it might have. But we've changed.

11 MR. EHMIG: But in some of the agreement states it 12 still may.

13 MS. HANSY: Okay, i

3 14 MR. EHMIG: I from Illinois.

l(

f 15 MS. HANEY: Okay. So to answer from any -- at

'16 least part of the question from the NRC's standpoint, that 17 is where we have brought in a certain amount of dose-based.

18 Is that it would not have triggered a medical event with the 19 diagnostic range. We would not need to hear about it if --

, 20 under the proposed 35, it would not even considered a 21 recordable event. Something that we would ask the licensee 22 to even look at.

23 One would hope that internal hospital procedures, 24 however, would cause them to go look. And what we're trying

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157 1 care about that. It's in a low-risk area that not to exceed 2 our dose threshold.

3 However, when you're looking at the therapeutic 4 doses, then that would trigger a medical event. And then we 5 would want to know about it. And, hence, the regulation at 6 that threshold. And -- I mean, is that what you were trying 7 to get at.with that example?

8 MR. EHMIG: I guess I'm coming from the issue of 9 an event and IDMS (phonetic) jurisdiction from some time.

10 That there's 36 sets of rules around the country, and I 11 don't know that we'll ever change that. But my thought is 12 that NRC should be leading the pack.

13 MR. CAMERON: And it's not mine to say that we're :

14 leading the pack too much. That does happen occasionally. !

G(_) 15 Roy, go ahead.

16 MR. BROWN: Don, I just have a follow-up to-what 17 we've been talking about. Since you' guys look at different 18 ways of doing this -- for example, perhaps licensing or 19 certifying an RSO or any position practicing diagnostic 20 nuclear medicine to come in under the umbrella of that RSO 21 or nuclear-involved facility, any number of physicians could 22 come in and practice in a group or a pharmacist can come in 23 and practice in a group pharmacy, or physicians to come in 24 and practice diagnostic nuclear medicine, rather than 25 licensing the way you license now. A different, truly new ANN RILEY & ASSOCIATES, LTD.

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158 1 way of licensing?

(~ l 2 MR.' CAMERON: And that's a good thought. I mean V

3 maybe if we could generate some more of these things, there 4 would be something for the staff --

5 MR. BROWN: I mean, some sort of an umbrella 6 license where someone would watch the people come and go and 7 dispense as many doses as they wanted, or do as many 8 diagnostic procedures as they want.

9 DR. COOL: I think there was some discussion that 10 might not have been that particular one. It's been long 11 enough now that I'm not going to recreate it, because they 12 have a lot of that information in there that makes the 13 tech's handbook look like a law book.

14 But there were some considerations. But there's

) 15 certainly no harm in tossing some of those ideas back up to 16 be re-examined.

17 MR. CAMERON: Good, thank you. Bob?

18 DR. LULL: Two things. One: For Bill, the 19 difference between 200 and 220 millicuries for a cancer 20 therapy patient is truly, really not significant in terms of 21 any kind of-harm or risk to the patient, even though it 22 seems like it's a big amount, big difference, when you're 23 talking about that. The circumstance is it's really not a 24 major -- it wouldn't be a real issue. It wouldn't be a real 25 risk.

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159 i 1 Number two: I have a real problem with the term '

E 2 " risk-informed regulation." What it's saying is because 3 we're bothered because of calculating hypothetical low-level 4 risks on high-dose patients, which may not be valid to do in 5 any case. We're setting up a situation where we're going to 6 listen to all that you have to say about risk -- relative 7 risk -- but we're going to do what we were going to do, i 8 anyways. Which means to say that we're informed of it, but 9 we're going to make our rules without really using this as a 10 real filter.

11 So we're going to have a filter that we can put in 12 place or take away, depending on what suits our i 13- perspectives, regardless of the risk analysis. And I think 14 that's wrong. I think the risk analysis should be there and

() 15 16 it should be for real risks. l You know, you can talk about hypothetical risks, 17 but eventually you get to a point where you need to measure i 18 what the risks are. And that's when you look at data. I i

19 Now we've got data for nuclear medicine. We show l 20 that-the-risks are infinitesimally small. This is the 1

21 definition of risk. We should stop using theoretical risks i 22 and we should start using real risks. And we've got -- as I 23 said, all the risk data is measured. The risk of dying in 24 an airplane crash versus an automobile crash. The risk of a 25 kid dying from a bucket, because the bucket's got water in ANN RILEY & ASSOCIATES, LTD.

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160 1 it.

2 You can theoretically that can happen with a 4

(}

3 toilet, saying you can have all kinds of regulations about 4

4 toilets not having water in them in the resting state I

5 because'a kid could drown. The fact is that kids don't t

6 drown by sticking their heads in toilets like they do with 7 buckets. You know, you can have a whole toilet regulatory 8 agency out there, you know, trying to control how much water 9 is left in a toilet bowl, to try and prevent something like 10 the bucket deaths, which we know with buckets that kill 50 11 kids a year in this country.

12 And, you know, I don't think anyone would support 13 that.

14 I could see an agency that got started that way,

() 15 trying to maintain their control over toilet water level, 16 because of the hypothetical risk. When you look at it, you 17 find out that there are no risks. And that's certainly true ,

l 18 with nuclear medicine. l 19 Now, I admit that when we look at the risks -- the 20 real risks that eventually occur -- the real harms that have 21 occurred in nuclear medicine, you have to realize that those 22 have been what's happened under the regulatory control 23 that's existed in the past. So if we're talking about 24 removing a lot of regulatory control, then I think that it 25 might be reasonable to look at whether there's some increase

/}

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161 1 in those risks if you remove the regulatory control.

N 2 Now you're talking about recommendations. I have

(Y

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3 a recommendation: It's taking into account the traditional 4 difference between the un-agreement state of California 5 here. Why don't you consider delegating to the California 6 Agreement State a special circumstance -- you might not like 7 this, but -- and let California issue general licenses and 8 see how it goes?

i 9 We're big enough that we can provide, actually, l 10 pretty good statistics. And it would be a trial balloon to l

11 see what happens when you do that.

12 How many problems -- how much harm will actually l 13 get created in the state of California if they started doing

-14 all of their diagnostic procedures under an agreement status

()

LJ 15 that frees them from the NRC regulation and allows them to 16 generate what they think is appropriate for their state and

\

17 utilizing all of the other things that are currently in 18 place there to exercise control?

19 Now, you're talking about how, you know, if you 20 get rid of -- put a general license out there -- because 21 there's going to be costs for putting in controls and 22 licensing -- the same kind of license-kind of things that 23 control what happens, say, at the University of California.

24 They're still going to need to control the use of 25 radioactivity in some way. But they don't to do it there p ANN RILEY & ASSOCIATES, LTD.

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162 1 plus have it done at the national level. They could end up

(]

U 2 having it done just there. And they're perfectly competent 3 in exercising adequate control.

4 You know, those costs won't go away, but they 5 don't need to have double costs and double paperwork and all 6 the kind of stuff that currently is going on.

7 I hope I haven't lost you with all of the words, 8 but I think that the point is that there ought to be real 9 risk association. And we have to be very careful about how 10 we're defining risk and very clear about how we define risk.

11 And I think it's time to look at the real data and start 12 defining risk on that basis, rather than hypothetical.

13 MR. CAMERON: Okay, good. Thank you, that's 14 another suggestion, possibly. Either a pilot program or in I 15 some areas, set performance standards and let the agreement J 16 states decide how to implement that.

17 Sue? Then we'll go to Ed.

18 MS. MC LAUGHLIN: Okay. While I agree with i 19 everything that seems to be being said here about the low 20 level of real risk involved in these procedures, there's 21 another kind of risk that I think we just need to keep in 22 mind as we are talking about these issues here.

23 And that is tho perceived risk on the part of the 24 public. Because very often when the public hears the term 25 " radioactivity" -- regardless of the level -- there's a i

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163 1 perceived risk there. And that doesn't mean that we should

} 2 maintain the regulations just on the basis of the perceived 3 risk.

4 But I think that there is going to be an education

, 5 component on'the public level that would be involved with 6 something like this, as well.

7 MR. CAMERON: Thank you, Sue.

8 Are there comments on Sue's point about the 9 perceived risk and how important that can be to the public, 10 particularly, perhaps in this area?

11 DR. LULL: NRC could become sort of the NRC and 12 NEC, Nuclear Education Commission.

13 MR. . CAMERON: And that's not completely facetious.

14 DR. LULL: No , it's not.

() 15 MR. CAMERON: Okay. I didn't think so.

16 Nikki, you have a card?

17 MS. HOBSON: I think if you look at the people who 18 are the recipients of these treatments, the patients, they 19 are basically, I believe, unaware of all of this -- the 20 regulations that are designed to protect them. They get the 21 radiation treatment because they think it's going to do them 22 some good, that's going to solve their problem or make them 23 feel better and save their life. ;

24 And I -- I think if you did away with the 25 regulations or some of them -- the ones that you feel are l

[)

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164 1 not cost-effective or related to the actual risk, most

(~') 2 people in the public sector -- I don't think they would care V

3 one way or the other. If they need radiation treatment, 4 they're going to get it.

5 MR. CAMERON: And do you think that -- that there 6 --

associated with that might be some assurance in their 7 mind that there is some sort of regulatory body -- say a 8 state medical board or something --

9 MS. HOBSON: I think private or state. I think i 10 that patients in general do rely on the oversight of all ,

11 kinds of professional organizations -- medical associations l 12 that helps us in society -- HDMP (phonetic) -- plus the l 13 state government plus the federal government. I think 14 there's a combination here.

v) 15 But, you know, having one or two less or more 16 federal regulations, I don't think is going to make any 17 patients sleep better at night. If they need radiation 18 treatments or use of radioactive materials for their health 19 care, they're going to go get it.

20 MR. CAMERON: Okay, thank you. j 21 David?

22 MR. BELK: I think Susan's right on. The issue of 23 perceived risk -- just coming from the university's 24 perspective, from the administrative side, it's a huge 25 issue. Millions of dollars have been spent of university

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165 l 1 money dealing with the perceived risk as to how safe they 2 are. There are some real risks there.

3 The perceived risk by the public at large --

4 particularly against a large institution or a large i

5 governmental agency -- is huge and formidable. The 6 educational process is horrendous to overcome that. But it j 7 is an issue that does have to be dealt with, and I think 8 that Susan is absolutely right. Regardless of the 9 discussion of how do we define low risk, actual risk -- i 10 whatever. For lack of a better term, a perceived risk is 11 one that we cannot ignore.

12 MR. CAMERON: Okay. Thank you, David.

13 Mary Pat?

14 MS. MANNING: I'd like to second what's been said 15 about " perceived." When we take a look at the culturcl 16 groups and what their perception of radiation is -- not 17 radiation therapy, but probably around implants and isotopes 18 are two big areas where as nurses we constantly have to keep 19 just de-mystifying what's going on in trying to encourage 20 and support folks. Where families put people still in 21 isplation if they've gotten a therapeutic dose of IDEM 131 22 (phonetic) and they've been cleared to go home. Or patients 23 who have gotten an implant and they're home after.

24 So it's not just cancer, but it has to do with the 25 public in the different cultural perspectives -- especially O ANN RILEY & ASSOCIATES, LTD.

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166 l'

Asien and Hispanic -- where that's been the focus of where

/S 2 I've been the last number of years. There's a very huge U 3 perceived.

4 So it's really an educational process that needs 5 to go out. And how the media picks up on any changes -- if 6 there's any way that one has a way of putting statements 7 out.

8 I'm not sayino that it should preclude us, you 9 know, going forward with rule making. But I think that 10 piece is really important.

11 MR. CAMERON: Okay. There are a number of you who 12 have spoke to the importance of this. Let me ask Don a 13 question about -- how does perceived risk factor Anto -- I 14 mean are we going far afield T.are in terms of where Part 35

() 15 16 is or could end up by talking about perceived risk?

DR. COOL: Not completely, but partially. I would 17 like to think that most of what you've done to propose the 18 rules is driven by something which is more closely aligned 19 to real versus contamination levels, dose levels, and the 20 perception. But perception underlies almost everything that 21 ends up happening in the radiation regulation and control 22 arena, because most of us who have been around the agency 23 for any length of time have in our data base at least one or 24 two summons from somewhere on Capitol Hill And it doesn't 25 take too many of thost to result in there being changes in ANN RILEY & ASSOCIATES, LTD.

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167 1 direction.

2 A summons of the Chairman to explain -- or the 3 Executive Director to explain why certain things were or

-4 were not being accomplished will change the directions of 5 the agency programming in a matter of minutes.

6 MR. CAMERON: Okay. Thank you, Don, for that.

7 Let's go to -- let's go to Ed. You've had your 8 hand up onere for a while, and then we'll go to Charlie and 9 Nikki.

10 MR. BAILEY: I'll go back to one of the things 11 that you said about Illinois and the old rule, basically, 12 where you're still reporting diagnostic. l 13 We, too, have that rule in California. And I must 14 say that the most serious mis-administrations -- which is

() 15 16 what we still call them -- involve diagnostic, and it didn't have anything at all to do with regulation. It had to do 17 with putting the wrong white blood cells into someone that 18 they didn't come out of and using a needle that somebody l 19 thought had a dose in it that they had previously used on an 20 HIV positive patient to stick a second patient.

21 I think that it would be very helpful if we could l 22 get down to where we're talking about real threats to the 23 patient as being things that needed to be looked into. 1 24 Because we have the luxury of also licensing the nuclear med 25 techs.

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168 1 We took action against the two med techs and we

'D; 9 2 think that.is appropriate. Because under the -- under the

3. regulations that we have for the technologists, they're 4 supposed to -exercise due diligence in doing their job and so

-5 on and so on and they quite ' imply didn't do it.

6 Similarly, an' iodine therapy case, we have a rule

, 7 that if you're going to give liquid doses -- therapy doses 8_ -- that the physician prascribing it must be physically 9 prenent when the dose is administered. The physician was 10 not there. And so we've.got a real mess-up. It probably 11- would not have occurred if the' doctor had been there who had 12 prescribed it.

13- I think one of the things that could be eliminated 14 - _and I'm notLreally sure why it's necessary -- and that is

() 15 the written directive. It seems like that's one thing that 16 since most of these things are legend pharmaceuticals, there 17 are already requirements on who can give them, how they go 18 about documenting what they give, and so forth. Say the 19 patient chart, or whatever.

20 I'm not sure that we need to duplicate that or go 21 beyond what is normally required for giving any kind of drug }

22 to the patient -- o. 3.ny kind of treatment to the patient.

23 The last thing I wanted to mention was perception.

And I -- I'm not sure that we don't -- as regulators, anyway l

24 25 -- contribute to misconceptions. And I would simply give as ANN RILEY & ASSOCIATES, LTD.

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I 169 1 an example some spent fuel that went through California ,

2 recently -- that those of you who are from California know 3 about. The same shipping routes have been being used for 4 years, but the Department of Energy decided they would 5 inform the public that they were doing this. And so they 6 ended up spending probably a million and a half dollars to 7 do the same thing that they had been doing safely, using the 8 same containers, to get this fuel from San Francisco Bay to 9 'Novato -- including having four of our health physicists 10 trailing along on the road, so that we could see those 11 casks, you know, if they fell into the river.

12 So I think that we sometimes contribute to the 13 misconception of the hazards and things by the efforts we go 14 to to regulate.

15 And so we might back off on some things and start 16 taking the position that they don't need ali of these 17 regulations.

18 MR. CAMERON: Thank you. Charlie and then Nikki.

19 MR. SHOWALTER: Actually, my comment feeds into 20 what Ed was just saying. I happened to be in a large Texas 21 city last week and heard the following report on the local 22 news: A truck had run off the freeway -- and they had a 23 picture of it -- and in the back of the truck was a dental 24 X-ray machine. And there were radioactive -- radiation 25 signs on it. And the news reporter said that the hazardous b

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170 1 material people were called out and carefully examined the

( )' 2 machine and had determined that it wat not leaking any 3 radiation.

4 I don't know what that means in terms of all of 5 this perception of risk, but it's there.

6 MR. CAMERON: Okay, thank you.

l 7 Nikki?

8 MS. HOBSON: Okay. Back to the first. You know, 9 certainly it is'real'. There are some people that perceive 10 that there is a risk connected with anything nuclear. And 11 you could quadruple the regulations -- make them stricter 12 and tighter and you are not going to change those people.

13 They are still going to be leery and fearful of anything 14 radioactive.

) 15 So what are we doing here? Are we going to 16 penalize patients and make them pay more, mhke the services

)

17 less available, harder to get to, by enacting or enforcing i 18 regulations that don't benefit the patients? If it doesn't 19 help the patients, why should the patients pay for it? It's 20 not going to change that element of society that we're 21 talking about that has this perceived risk that nuclear is 22 bad.

23 MR. CAMERON: Thanks, Nikki. I see Sue has her 24 card up.

25- MS. MC LAUGHLIN: Okay. I just want to say that I i

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171 1

agree with you. I don't think that we should be supporting

] 2 rules for the sake of the fact that they've always been ,

3 there, if they really are not truly serving a purpose.

4 The only reason I brought up the perceived risk at 5 all is just that it's something that we keep in mind as we 6 are going through this process. That from a public 7 relations standpoint or an education standpoint or something 8 like that, there may be something additional that we need to 9 throw in the mix to deal with that perceived risk.

10 MR. CAMERON: Okay. Thank you, Sue.

11 Melissa?

12 MS. MARTIN: This may be a question that will come 13 up later, but I just want to sort of flag it up there so 14 that we don't forget it.

() 15 Back to the written directive, I'm not sure that's 16 going -- where that actually comes up for discussion. But 17 one of the questions we had is how a're you dealing -- what 18 is the proposal for dealing with the equivalent of what I 19 would call electronic signatures or signatures on file for 20 physicians? Are those going to be accepted for written ,

l 21 directives or are you physically looking at having that 22 physician give a, quote, wet signature?

23 In today's world of teleradiology, particularly, 24 or tele-medicine in general, for ordering the doses, say, 25 for a patient, most hospitals have established protocols for ANN RILEY & ASSOCIATES, LTD.

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172 1 accepting orders. But I did not see anything in the 2 regulations on how this is going to be dealt with.

(} And I 3 just think that it's a matter that needs to be flagged for 4 discussion.

5 MR. CAMERON: Okay. We're going to put it up 6' here, and then make sure that we address it when we get to 7 that area.

8 And I'm using your term, " wet signature," right?

9 MS. MARTIN: Versus electronic.

10 MR. CAMERON: Okay. Thank you, Melissa..

11 As I indicated, we need to move on to the audience 12 to get some ideas from them. :But there were four things

. 13 that we'came up with here. And I don't know if anybody

, 14 around the table wants to comment on any or all of them,

() 15 about whether they think that they're feasible. )

16 Bob?

, 17 DR. LULL: Yeah, I had -- I'm sorry. I had a 18 comment that it sort of falls to the last conversation about 19 what a signature is. Because a signature -- a written l

20 directive -- basically it's lining up responsibility. What t

21 we're really talking about in the licensure process is the l 22 definition of responsibility. And so my comment that I 9

23 wanted to make is about this line that says "RSO 24 certification."

25 Number one, I notice that -- and I haven't read 4

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4

173 1 through all of this. But I know traditionally the NRC has

("' 2 been very lenient in its definition of what requirements are D) 3 necessary for an RSO. And I think in the proposed document, 4 it lets it be up to the licensed -- the user to define what 5 the RSO training and experience and requirements are. Is 6 that -- I might be wrong. I saw something that looked like 7 it was like that. So I stand to be totally corrected on 8 this here.

9 But basically licensing -- the license has to 10 really be directed to the person who's responsible and, 11 therefore, in control. Someone should not assume the 12 responsibility and honestly have control for the entire 13 process and be guaranteed that it's done properly.

14 MR. CAMERON: Okay, thank you.

I 'h 15 Bob, do you have something on that?

U 16 DR. LULL: Yeah, that RSO certification, that l

17 could. easily be a hospital administrator certification or a 18 program administrator or somebody that is certified or 19 recognized to have oversight responsibility for the entire 20 program. And in that way, physicians could come and go and 21 procedures could come and go. Where someone would have 22 total responsibility and not yet what we consider now a 23 professional license. That was a good point. Whether it's 24 the RSO or the administrator or somebody else.

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174 1 now.

/~D 2 U DR. LULLi Yeah, but without exceptional limits 3 .(phonetic), without the prescriptive things. The way I 4 envision it is one with more ability to do more 5 performance-based, and as long as you meet the standard --

6 you meet the oversight responsibilities, then you can do 7 whatever you want.

8 MR. CAMERON: Okay. Thanks, Roy. l 9 And I take it that what you'd like to discuss on l 10 that particular thing is that -- have a discussion about the 11 methodology that's being used?

12 DR. LULL: Yeah, and the results -- or what we 13 expect the results to be.

14 MR. CAMERON: Okay. But moreso than we've had so O

( ,I 15 far in terms of Don's explanation.

16 DR. LULL: Yeah, both methodology and results.

17 MR. CAMERON: Okay. All right. Do the regulators 18 from California or Washington have any comments about the 19 performance of standard approach pilot program that was 20 raised in terms of training the states to decide how to do 21 it? Terry?

22 MR. FRAZEE: Several years ago NRC voted, in a 23 sense, for this general license for the medical area. And I 24 believe the agreement states -- maybe not as a whole, but 25 mainly the agreement states were opposed to that particular

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175 1 concept. The general license in the field source arena has 2 We've got more problems with that, (s-) not gotten us anywhere.

3 the kinds of using a general license for field source.

4 So we're not too wild about the general license 5 idea, in general. !

6 The radiation -- or the RSO certification, that 7 has some merit to it. Again, reflecting on it, we're 8 looking for folks that are handling material. Again, 9 technologists, the radiation safety officer. I think we're l

10 generally going to positions dealing with patients. The '

11 folks that are really using the materials, we want to know 12 or make sure that that's being done appropriately.

13 Again, there is some risk. I think we can handle 14 that, but we're not totally willing to just (inaudible). So 15- we're getting a general license from our standpoint of the I

16 RSO certification process. That has some merit. l 17 Giving the states flexibility? Sure, we've been 18 asking for that for years and years and years. Whether or 1

19 not California, as an example, is willing to tackle that as 20 a project? I'd love California to decide that, to have that 21 licensing that might make sense. It would not make sense 22 for the state of Washington with our relatively small 23 numbers to try that as a test case.

24 And the -- again, I agree with the record part.

25 MR. CAMERON: Good, thank you. Ed?

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176 1 MR. BAILEY: When I heard the proposal, I thought, r 2 well, no, I'm not sure I want to do that.

) But one of the 3 things that we've recently done here in California is 4 establish a nuclear medicine council. And it has several

5 purposes. One of which, of course, is to improve 6 communications between the regulatory agency and the medical 7 community who are using radioactive materials.

8- A second definite thing was to meet with these 9 people and discuss what's coming down the road. Because

10 most-new things that will come out in medicine or nuclear

, 11 medicine probably will appear some place in California

. 12 before they get approved by FDA as routine.

i 13 So we thought if we could -- if we could settle 14 all of our questions in regard to these products before they

() 15 became finally approved -- examples are starch in '89. We 16 went through all kinds of stuff about how we were going to l 17 license it, how we weren't going to license it, and so i 18 forth.

19 If we could go through and solve those before they 20 became readily available, then we could make our job easier l 21 and we could make the regulating community's job easier.

22 A long-term goal of this group is to look at the 3

23 regulation of nuclear medicine. And the idea of the general 24 license -- I don't know if I would go that far. But I would 25 say that we could certainly set up a license to an )

I l

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177 1 I institution -- which we do not -- and in regulation say that

/'T 2 doctors with these qualifications may be used to perform b 3 nuclear medicine studies in this hospital, as opposed to 4 naming each one of them.

5_ One of our -- one of the things that sort of holds 6 me back from thinking that would really work is some of the 7 stuff that we're seeing now going on in managed care and-8 HMOs, where some of these facilities are trying to push the 9 boundaries of who can do nuclear medicine. So that you {

10 don't have a nuclear medicine physician doing nuclear i

11 medicine. You have whoever happens to be on duty doing it, !

12 reading the scans, and so forth. And that we are really

13. dragging our feet on saying that that's a good idea. !

14 So if we had it in regulations, though, of the

() 15 qualifications of the people that had to do it, so that the 16 hospital administrators and so forth could look right in the 17 regs and see they've got to have this thing to do these 18 things, then I think it could work. 1 19 We, I think, pretty much believe that that

20. authorized physician is responsible for selecting the study 1 1

i 21 to be done, which includes the dosage, interpreting that or 22 providing the diagnosis. And that has not occurred in all 1

23 current licenses. And there's been waffling on who could do l 24 _those, quite frankly. l 25 MR. CAMERON: Okay. And I think there's another i

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5-178 1 alternative in there, somewhere, for the staff to take a 2 look at in terms of this rule.

'u 3 Anybody in the audience? Roy, do you still have 4 your --

5 MR. BROWN: Yeah, I just want to make one comment.

6 I think the RSO certification vernacular has been 7 misunderstood, so maybe we could change that to something 8 else. I'm not talking about certification of ourselves, I'm 9 talking about one authority that has oversight for the whole 10 program. That's more on line of what I heard saying here.

11 You set up a standard of where as long as a physician meets 12 the standard, then he can practice that diagnostic nuclear 13 medicine.

14 I'm not talking about an RSO certification 15- program. I'm just talking about a standard you have to meet 16 to practice diagnostic nuclear medicine.

17 MR. BAILEY: We do that for visiting physicians 18 now, anyway. If a facility has a physician and he's absent, 19 then somebody else can come in and work for a while, anyway, 20 MR. BROWN: There's got to be c better word than 21 " certification." Maybe you can call it an institutional 22 license certificate.

23 That could mean chat you certify an administrator 24 or an RSO or a standard for physicians or something like 25 that. It could be'a lot of thin s.

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I 179 1 MR. CAMERON: All right. Go ahead, Bob.

2 DR. LULL: Yeah, I've been harping all afternoon 3 -- or all morning, I guess, about, you know, decrease in 4 regulations. And, of course, that's the thrust I'm going to 5 push. But I want to echo what Ed Bailey was just talking 6 about, because we aren't looking at a huge change in the 7 medical practice environment in managed care. And, quite 8 frankly, in order to do the right thing oftentimes we leave 9 it up to a decision for the physician. Like he decides that 10 this patient has enough support at home, can be isolated 11 sufficiently, and we'll call my directors and we'll, 12 therefore, not contaminate the environment and expose the 13- general population to anything over 500 milligrams. We can 14 let this person go. But this one, we can't. I need to

() 15 16 hospitalize him.

But then you have the managed care person saying, 17 "You've got to get my permission to hospitalize him, and 18 this is someone that we think, 'Way couldn't this one go 19 home?' And we're not going to allow it."

20 You know, I think -- you know, managed care 21 people, like -- are kind of like inspectors, and perhaps in 22 your programs, they don't like fuzzy rules. They want 23 clear-cut rules that are precise and this is a fuzzy one, 24 where it lets the doc make the decision.

25 They don't want to let the does make the decision.

p)

N, s

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i 180 1 They want to make the decisions on their hard and fast 2 rules.

l -\_()) So we need to be careful when we recommend )

] 3 decreasing the levels of regulation, that we may end up

+

4 indeed actually causing harm because you may need some 5 regulations to get the right things done within the managed 6 care, cost-savings environment that we're currently !

7 entering. Which is not fully developed yet, so we don't d

8 know for sure where that's going to go.

i 9 MR. CAMERON: That's a good point to consider.

10 I'm not sure where -- as you say, the lines are not clear !

11 about that at this point.

12 Let's get to the audience. Are there any comments 13 on the risk issue? Then we'll take a little-break and then 14 we' re goir.g to start of f with Dale Austin, with the

( 15 Federation of State Medical Boards. We're going to look at 16 professional standards, economic standards, and issues like 17 that.

18 Does anybody have something? !

19 MR. TAHMASSIAN: I thought that risk base was very j 20 complicated and confusing. I'm finding that risk-informed 21 is, at best, wishy-washy. i l

22 We talk about this global approach and I'm even i

23 more confused. I'm going to pose a very specific question l 24 to the NRC staff and try to understand your thought i

25 processes and what you mean by " risk-informed."

i 4

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181 1 35.6, Part A says, "A licensee shall develop,

() 2 implement, and maintain regular procedures" -- and 3 (inaudible) -- containing radioactive pharmaceuticals.

4 Now, if I understand the risk-informed 5 description, I can write a note to my file which says, 6 " Based on 120 months of monitoring, nobody has got an 7 exposure exceem ~

ihe requirements."

8 Is that how you are looking at risk-informed?

I 9 I have now made a decision on implementing this

'10 part based on the practical risks that I have in front of 1'

11 me.

12 MS. HANEY: Yes, you can do that.

13 MR. TAHMASSIAN: If that's the case, then why do 14 we need this? Because we already have the section which

() 15 says " sets down exposure rates" and to not exceed them.

, 16 MS. HANEY: Right. We had a lot of discussions at 17 the working group --

18 MR. TAHMASSIAN: This, by the way, is throughout 19 the document. I just read this one because this is the 20 easiest for me to quantify right now.

l 21 I mean line-by-line, you can go through this. You 22 can go into a risk-base, but we're going to paraphrase the l 23 whole statements and instead of -- we're repeating them. So

2<4 that's what I'm trying to understand.

L 25- MS. HANEY: Okay. We had a lot of discussion l

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182 1 about that particular item at the working group level. If

() 2 3

you go back to -- you know, one of the versions that we had in that section probably did not appear in the rule.

4 And then after further discussions with members of 5 the working group at -- all the working group meetings were 6 public, so we had members from the public. We had 7 physicists attend. We had representatives from the APM come I

8 to one of the meetings.

9 It came up that there are certain things that need 10 to be in the rules. The reason for not having it in the 11 first person was that it was covered by Part 20: Licensee 12 do what you want as long as you keep it and you stay within 13 the dose limits.

14 However, the questions that were being asked were, fh

(,) 15 well, you do have Part 20. But if you get into the larger 16 quantities or the non-sealed material -- like get into the 17 35300s, you now have the potential to exceed the public dose 18 limits on a much quicker basis. And, therefore, there was a 19 risk associated with having a vial sit out there that 20 contains 300 millicuries of I-131. And, yes, Part 20 was 21' there theoretically and would cover it. But we thought that 22 that justified a more prescriptive regulation.

23 We did not want to go so far as to say, "You will 24 shield at X millicuries." We stayed away from that, and it 25 was because we wanted the licensee to have the flexibility

\-)

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183 1 of coming up with their own program and saying, "At" -- you fg 2 know, your procedures may say if we're in the diagnostic

' V 3 dose range, we're not going to shield. But if we exceed and 4 get up into'the therapeutic and, you know, 100. millicuries, 5 then our procedure is to shield. But that's up to you as a 6 licensee to make that cut.

7 MR. TAHMASSIAN: Thank you.

8 MR. CAMERON: Okay. Any final comments on risk?

9 David?

f 10 MR. NICHOLS: Thank you. David Nichols, American 4

11 ' College of Nuclear Physicians and Society of Nuclear

12 Medicine.

i j 13 I think one of the problems that there is such 14 difficulty in defining risk in finding what the NRC must do

( ) 15 to minimize risk, as cell as to maximalize it, is that you 16 haven' t done a good job in a proposed rule about explaining 17 what you perceive the problem to be and'how the' regulation 18 will solve that problem.

19 There's still a lot of fuzziness about what you're 20 concerned about. I think the example we just heard there, 21 where, yes, there's the possibility of a 300-millicurie vial 22 laying out on the counter somewhere and-exposing someone is 23 just to allow it. I mean if it hasn't happened, if there's 24 no data set that shows that that does happen, then why do we 25 'need a regulation to give -- to regulate out that jq ANN RILEY & ASSOCIATES, LTD.

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I 184 l 1 probability? l i

rg 2 And the same thing goes with retroactives. You 3 have data that shows that this administration -- you've got j 4 10 or 12. incidents of mis-administration in nuclear 5 therapeutic medicine out of 60 to 70,000 procedures done !

l !

6 every year. That, to the Society of Nuclear Medicine, is 7 not there yet or evidence to warrant a regulation governing l

8 therapeutic nuclear medicine. And that's where I think some !

9 of the difficulties is coming about in this discussion.

10 There's not enough detail and discussion that took place in s.

11 the working groups, that took place in reviewing your data 12 tables, to thoroughly justify why you need these 13 regulations.

14 And the burden should be on the agency to say this

( 15 is the problera and this is how the regulation will solve it.

16 It should not be thrown out to the regulating community to 17 battle the agency's perception.

18 MR. CAMERON: Okay. Thanks, David. And I think 19 that that comment would probably generally apply to talking s

20 about the areas of issues of low risk or high risk.

21 In other words, providing enough of a rationale so 4

x 22 that people can understand what the objective of the 23 proposed rule is.

1 24 Okay. I think I'll let this group go, since we'll 25 probably see you about 5:30 just when everybody is ready to i^ -(~% ANN RILEY & ASSOCIATES, LTD.

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185 1 break up.

2 f N But why don't we take a break and be back by

\j 3 quarter to 4:00 and we'll start off with Dale Austin and the 4 Federation of State Medical Boards?

5 [ Recess.]

6 MR ., CAMERON: -- the NRC regulatory regime. And 7 to that effect Dale Austin, from the Federation of State 8 Medical Boards in Texas, was nice enough to come out to tala 9 with us and sort of kick this discussion off with a 10 presentation on State Medical Boards and for those of you 11 who might have been familiar with the workshops that we 12 heard last year, we heard a lot of comments about what the 13 Medical Boards do and you don't need to have this type of 14 regulation or that type of regulation.

()

/'N 15 16 practice I also-want to get into any issues concerning reimbursement. We just heard interesting thought 17 from Bob Lull before we broke about the interface between l

18 practice reimbursement and the regulatory regime and of j 19 course the joint commission also plays into this.

20 And the is NRC is sponsoring a workshop on 21 September 1st _ ilicago. It deals with the use of quote, 22 " industry standards," unquote and you'll see in the 23 supplementary information to the proposed rule that the new 24 law that mandates agencies to use industry -- standards in 25 mentioned a couple of times.

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186 1

One in the context of the Medical Policies 2 Statements, so let's see if we can get into those issues and 3 I would just introduce Dale Austin over here and he's the 4 Deputy Executive Vice President for the Federation of State 5

Medical Boards and Dale has been with the Federation for 6 about four years now and he has 20 years plus experience 7 in hospital, clinical management and administrative 8 experience. He has a Bachelors in Nursing and a Masters in 9 Health Services Administration; both of those from the 10 University of Wisconsin, Madison, and thank you for being 11 with us Dale and I'll just turn it over to you.

12 MR. AUSTIN: Thanks. As Don mentioned this 13 morning it's risky business to turn the lights on. This 14 morning it's even riskier because it's four in the afternoon

() 15 but I'll try to stay awake if you will.

16 When Chip called me about making this 17 presentation, I really had to sort of scratch cty head and 18 try to figure out what to tell you about Medical Boards so 19 I'm going to try to do a brief overview of why Medical 20 Boards exist and what they do and invite any questions and 21 comments along the way so at any point feel free to ask 22 questions.

23 First of all, we have, as you're all aware, I'm 24 sure, have a system of state based licensure in this 25 country. True for physicians, true for most of the other ANN RILEY & ASSOCIATES, LTD.

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187 1 health care disciplines as well. There are 71 Medical

(} 2 Boards in the country; that includes the territories. Many 3 states, like California, for example, have separate 4 allopathic and osteopathic medical boards. Other states 5 have composite boards for both allopathic and osteopathic 6 physicians that are regulated under one board.

7. The primary charge and purpose of medical boards 1

8 is protection of the public, why they exist. They.do that 9 through a licensing of the privilege, and I use that word 10 very specifically, privilege of the practice of medicine.

11 It's viewed as a privilege and it's from the licensing side 12 that physicians are able to practice and they do so under 13 the authority of the Medical Practices Commission.

14 MR. BAILEY: What about physicians such as those O

(j 15 at VA Hospitals in the military, do they have to be licensed 16 anywhere?

17 MR. AUSTIN: That's a good question. They need to 18 be. licensed in at least one state and then under the 19 Department of Defense umbrella that which carries them 20 throughout the DOD umbrella. If they however, were in a, 21 let's see, what's a good example, were practicing in a VA 22 Hospital, they're licensed in Oklahoma and they're 23 practicing in a VA Hospital in Texas and wanted to also 24 practice at University Hospital in Texas, they'd have to get 25 a Texas license because that's practicing outside of the

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188 1 umbrella. l 2

The Federation of State Medical Boards is a 3 ~ not-for-profit organization, really an association of 4 medical boards throughout the country. We exisc in Dallas, 5 Fort Worth is where our offices are. We have 69 medical ,

6 boards as our members There are, therefore, two 7 osteopathic, small osteopathic boards, one in Utah, one in 8 Connecticut that are not members of the Federation but they 9 do actually share information with us as well as we try to 10 work with them. They're so small they don't feel like

~

11 membership in the Federation is in their best interest.

12 The Federation really tries to provide some shared 13 Gervices, services that don't make sense to replicate 71 ,

1 14 times over. Look to standardize procedures, policies

() 15 throughout the country and by extension by focus on 16 protection of the public because that's what our boards do.

17 The Medical Practice Act is key to how a medical 18 board functions and how physicians function in each state.

19 It really outlines the regulation of physicians for that 20 particular state. In some states that's a very packaged 21 kind of act in the statutes; in other cases in falls under a l

22 variety of sections dependant upon how the statutes are 23 structured. In general, these are the elements of the 24 Medical Practice Act. There's a fair amount of similarity.

25 Several years ago the Federation established a (m /

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l 189 l 1 policy guide called the Essentials of the Modern Medical

($ 2 Practice Act. It's in its 8th edition at this point and we G'

3 find that most medical boards in the country have The :

4 Elements of the Essentials of the Modern Medical Practice 5 Act.

6 The State Medical Board then is charged with 7 operating under that medical act and these boards are our 8 members. They are made up of physicians, osteopathic, 9 allopathic and public members. Every board has at least 10 eight public members. In some cases, there are a little bit 11 less than half but the number varies from state to state.

12 These are generally Gubernatorial appointees to these 13 boards. They volunteer their services and it's a big 14 commitment. They spend a lot of time at this effort, both (n) v 15 in meetings but also in review of materials and work that 16 goes into both licensing as well as sitting in judgement 17 physically of public issues. They're focused in on 18 licensure, on discipline, on developing rules and regs for l

19 the details that aren't attended to in a medical practice 20 setting.

21 I'm going to focus specifically on the licensure 22 and disciplinary aspects. I think that's what you're 23 particularly interested in. First, I'll start with j

24 licensure and how that happens and then I'll talk a little I 1

25 about discipline. i

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190 1 The purpose of medical licensure, as I mentioned

( 2 earlier, fundamentally comes down to the protection of the 3 public. It's why all this exists. This graphic, I think 4 represents'some of the key components of initial licensure 5 and I emphasize initial licensure and we shall find when we 6 get into the reregistration and so forth that some of these

'7 things are not on that. So, initial licensure, three 6 particular components I'll spend a little more time on.

9 Common license requirements. Again, I emphasize 10 the word " common". They're common, they aren't neutral.

11 They are very much alike, much more alike today. Roy and I 12 were just talking and I think today we can say that they're

13 much more uniform then they once were but they're not where 14 we would like them to be for presentation of the state

() 15 licensure system into the future so there are still r

16 differences and variations.

i 17 Graduation from an approved school and I'll try to ;

18 describe the acronyms you see here: LCME: Basically an 19 accredited school in the United States and Canada. The 20 Liaison Council on Medical Education is a group that l 21 accredits medical schools, content of medical education.

22 Completion of approved postgraduate training 23 program. The range is from one to three years, that is 24 required for licensure in various states. In general, I 25 would say that most states require two years but it varies.

t

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191 1 There are a few requiring three years. There is a tendency 2

.f-s to want to move it to three years because there is such

\u,)g.

3 variation in what is covered in the first year versus the 4

second year versus the third year of postgraduate training 5 that there is a tendency to lean towards three years. Here j

6 again, another acronym: ACGME: The Accreditation Council on 1

7 9 Graduate Medical Education, which accredits postgraduate 8 training programs and then it's counterpart on the 9 osteopathic side is under the umbrella of the American 10 Osteopathic Association.

11 Foreign medical graduates have a little bit 12 different path because they are are coming from non-ACGME 13 accredited schools there is a different pathway and the 14 ECFMG, the Education Council of Foreign Medical Graduates, (Q/') 15 deals with those individuals. It's their pathway into 16 eventual postgraduate training and licensure in this 17 country.

18 Medical School education and its comparability in 19 those foreign medical schools is considered passage as steps 20 one and two of The United States Licensing Exam. English 21 competency exams and just recently have added a clinical 22 skills assessment exam that is utilizing standardized 23 patients to see their interaction with about 20 different 24 standardized scripted patients to see how they do and that's 25 all a part of them becoming ECFMG certified so that they can p ANN RILEY & ASSOCIATES, LTD.

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1

192 1 be eligible to enter a postgraduate training program in this

} 2 country and then eventually sit for the third step of the 3 examination and then the exam sequence as spoken to here, 4 using steps one, two and three. Since '92 - '94 time frame, 5 there has been a standardized exam for folks, for physicians 6 to take in this country to become licensed as true 7 allopathic physicians. Osteopathic physicians can also take 8 this exam. However, there is an osteopathic exam as well 9 called COMLE -- Comprehensive Osteopathic Medical Licensing 10 Exam -- that is utilized by a number of the Osteopathic 11 -Boards in the country and actually is under review right now

.12 for its comparability to the USMLE. We should see something 13 develop from that in the next few months.

14 License renewal is really license reregistration I 15 in large part. There is self-employing of video 16 information, it goes on in that process. There is a range 17 of one to every three years, if that happens, generally I'll 18 tell you that that happens every two years in most states.

19 But it does vary. Some states do it every year. We see 20 more and more states going to -- they're rotating that so 21 that it happens on different dates, they're trying to spread 22 it out so it happens, it gets spread out as opposed to it 23 taking them all at one time of the year. But there isn't an 24 effort -- a significant effort at least, to look at 25 reevaluating competency at that point in time. That's why

(~)

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l 193 1 the preference is on reregistration tests.

() 2 3

Licensure by Endorsement: Once licensed in one state, how do you get licensed in another state? Generally, 4 there is a recognition that licensure for another state.

5 First of all, that state that the physician is moving to 6 would look at the requirements that were in place for 7 initial licensure in their state at the time that the i

8 individual got their original license. So, they're not 9 going to hold you to the initial license requirements today, 10 they're going to hold that individual accountable for the i

11 licensure requirements at the time that they received their i 12 initial license. Additionally, if that individual physician 13 seeking licensure has not taken any sort of exam, whether )

14 there was an initial exam for licensure or a specialty (n)-

15 certification exam or recertification exam, they'll likely ;

}

16 be asked to take what's called a special exam, a special j 17 purpose exam. It is a -- based exam to assess their basic i j

i 18 level of competence to practice the undifferentiated 19 practice of medicine. So it tests everything. It tests in 20 10 different dimensions of medicine but not with great j i

21 depth. Enough to give you a broad brush sort of feel for !

8 22 continuing competence. Most boards today do recognize the 23 American Board of Medical Specialties. Certification exams !

l 24 and recertification exams doesn't need that kind of 25 requirement for their purposes. Many states may have )

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194 1 additional requirements like recertification requirements j } 2 and what have you.

3 Special licensures. There are.various categories 4 of special licensures that also occur; permits for 5 physicians that are enrolled in postgraduate training 6 programs. That's an effort that's been under way for some 7 time. It's recognizing physicians who are in that 8 postgraduate training period of time. They are doing a lot 9 of independent activity even though they are under 10 supervision and so forth, there is a great deal of 11 independence there and they ought to be coming under the 12 purview of the medical boards and so permits of one sort or 13 another usually for a year are the ones that are very common 14 today. And then special purpose licenses of one sort or

() 15 another -- telemedicine, is a key issue as we look at 16 practice across state lines of one sort or another. This is 17 an issue that each medical board is wrestling with. Some 18 boards have modeled after a model the Federation put 19 together that really is a simplified licensure application 20 that recognizes an individual having a full unrestricted 21 license in one state, giving them a license limited to 22 practice across state lines but it's limited to that 23 purpose . In other cases, medical boards have required full 24 and unrestricted license in their state in order to practice 25 any kind of medicine arena across state lines so there's a

('

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195 1 lot of unsettledness in that whole arena just yet and on

(

V}

2 Capital Hill there's a good deal of interest in this whole 3 arena both from the technology standpoint and the interstate 4 commerce standpoint and so there's a tendency to want to 5 intervene here and clean it all up and make it all alike and 6 make it not have licensure be a burden to that whole 1 7 practice. We can even try to stay ahead of that; we'll see i 8 what transpires in the next couple of years. l 9 Let's shift to the disciplinary role. Medical l

10 boards from a disciplinary perspective, this is where they .

i 11 spend most of their time. Licensure has become in large 12 part scenaardized a great deal. Many of the examination l

13 side efforts that go on with medical boards today are now 14 done by the Federation. We've taken on a lot of those kind

() 15 16 of roles. They spend most of their time in the whole disciplinary side of their jobs. It's a complaint driven i 1

17 system. A complaint needs to reach the medical board. In 18 large part, a complaint needs to get to them before their 19 going to be looking at somebody. They keep track of 20 complaints, they look at every complaint, they look at 21 numbers of complaints. Okay, a single complaint on x issue 22 may not be something that they feel a need to investigate or 23 devote resources to but if this individual had now gotten 1 24 that same kind of complaint five times in the last year's 1

25 time. That makes a trigger, so there's various kinds of (7 ANN RILEY & ASSOCIATES, LTD.

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196 1 triggering mechanisms that function there. They_do have

(' 2 limited resources; they're state agencies that have limited D} 3 kinds of resources whether those be people resources, money, 4 what have you, and so they have to prioritize the complaints

-5 that they can investigate and go after and so forth so that 6 does play a part. Where do complaints come from? A variety 7 of sources. Anyone can lodge a complaint. But how that 8 complaint gets into the system varies from state to state.

~

9 In some cases, it's as simple as a phone call and it's 10 logged as a complaint and something gets dome with that. In 11 other cases, you need to fill out the complaint in 12 triplicate on the medical board form and get it to them 13 before they call it a complaint. You can call them up all 14 you want but it's not going to count as a complaint. So we

() 15 deal with that all the time, too, because trying to do 16 apples to apples kinds of comparisons of complaint 17 processing is tough to do.

18 The complaints come from a variety of arenas. I'm 19 going to particularly raise a couple here that I think may R20 be germane to the discussion here.

21 Hospitals: Hospitals, much of what we are talking 22 about interrelates with hospitals and hospital reporting.

23 Hospitals are required to report to medical boards in each 24 state. They are also required to report to a national board ,

25 action data bank. The work that's going on in that whole

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197 1 arena indicates that hospitals are doing some rep vting but 2 it's woefully inadequate. There's not as much reporting 3 going on as it's believed should go on from hospitals and 4 there's some work under way to look at creating more 5 consequence to that lack of or that minimal reporting that 6- seems to go on. I'd also point out federal and state .

The NRC could be reporting that information as 7 agencies.

8 _ well. If there are sanctions, I mentioned this this morning 9 as a question, if there are sanctions that -- which is that, 10 I'm not sure what the terminology is that you use, whether 4

~

11 it's sanctions or actions of one sort or another but that 12 information ought to be making'it's way back into the '

13 physician regulatory community if indeed it's focused on the 14 physician or a physician is a part of that picture. It may 15

( not be. '

16 Range of Discipline: Everything from revoking the 17 privilege of licensure to a good talking to is within the 18 purview of the medical board. These come by different names i j 19 in the various states but that's really the scope that they p 20 .have. They really have a great deal of power over those 21 folks who are licensed by them. They tend to have very 22 little power when it folks who are not licensed by them but !

23 maybe tripping over into practicing medicine. Those they I 4

24 tend to have to hand over to the Attorney General's office

! -25 and be prosecuted through that route. So, over their 9

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1

198 1 licensees the medical board has a great deal of authority.

2 Those other folks, not a great deal.

}

3 First of all, they need to determine that they 4 done something that the Medical Practice Act in that state 5 speaks to or covers. So, does it fall under their J

6 jurisdiction basically. Secondly, depending upon the 7' violation, they're going to determine what the discipline 4

8 ought to be and they're going to individualize that to the 9 individual situation. There are a lot of parameters that go 10 into that thinking, both in how they've taken action in the 11 past in similar situations, but everyone is different, so, 12 there are a lot of mitigating factors that factor in there.

13 That individualization is tough to appreciate because once 14 it comes to a final action it's then public. In the

() 15 process, it tends to be very private and protected from a 16 due process kind of perspective so, the medical board often !

17 times doesn't have the opportunity to tell the whole story 18 of what went into there decision about the circumstance.

19 Reportinc 7isciplinary Actions: Final actions of 20 the medical board are public. They are available through 21 every medical board in the country and it varies as to how 22 available they are. In some cases, you can call a 1-800 23 number and they'll tell you what kinds of actions and what 24 kinds of history that particular position has. In other 25 cases, you can get that via the Internet, more and more via ANN RILEY & ASSOCIATES, LTD.

Og Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

199 1 the Internet. Massachusetts is now probably a year - and -

() 2 a - half into an effort to actually put profiles on the Internet to their licensees that really give board actions, 3

4 talks about specialties. A good deal of self - reported i

, 5 information from their licensees as well as malpractice 6 information; how does it compare to subspecialists in the i

7 same arena. It's a trend that we see continuing, that 8 there's a demand for more and more of that information being 9 made available and public and several states are interested I 10 in the same kind of legislative effort that is behind the 11 Massachusetts experiment. -

12 There is also reporting to the Federations Board 13 Action Data Bank. We maintain a data bank of all board 14 actions. It's complete back to the early 1960's, with

) 15 information that goes back to the 1940's. Our member boards i

16 can query that information free of charge and are encouraged l l

17 to do so twice in the licensing process. When they first !

18 get an application for licensure as well as just before 19 granting licensure is to run that through our data bank.

20 They can do so and it closes the door on a bad actor trying 21 to jump across state lines and get licensed somewhere else 22 when they find themselves in trouble. We can again look at 23 ways to enhance that whole process. These board actions, i

24 these final board actions are also reported to the National 1 25 Practitioner Data Bank maintained by the Federal Government.

[3

% s#

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200 1 It's complete back to 1991 and it grows each day. It also 2 has malpractice settlement information.

_3 Medical boards can take reciprocal actions as well I t >

1 4 so that if an i.ndividual is licensed in two states and one 5 state's taken action, the_other one where the individual is A 6I licensed.has the prerogative,to take~a reciprocal aetion.

,7 7 Sometimes that requires another hearing, may require some i 6 sort.of-action in other cases that may be merely automatic.

h 9- So inveking reciprocal action and the authority to do so is t

) l10 pretty much there. !

)

11 Some current challenges in this whole regulatory I 1

12 arena is managed care. We talked about that just a bit ago

13 and I thought we would talk more about that. Managed care i-

14 organizations are very data rich k: inds cf organizations and p(j) . 15 the Federation, working with-our member boards-in working at

] 16 s trying to build relationships between medical boards and

' 17 . kmanaged care organizations in each Utate to share that a

-18 information so that there can be more of a proactive market ,

! I L 19 and looking at whethur-physicians are getting out of since n 20 with normal practice patterns and so forth. We've got a E

. 21 long ways to go. Managed care organf.zations are new; this i.

1 22 whole: idea of working together is ner as well.

[r 23 Employment situations: More and more physicians

" 24_ are employers of some cort of managed care umbrella.. That

[ '

25 '

l changes a number of independent issuen as well, there are 1

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201 1 concerns for physicians in that thankless environment.

)

2 There are concerns from the medical board.

3 Medical Directors in Managed Care Organizations:

4 _ Viewing the Medical Director function of a managed care S' organization as the practice of medicine and they need to be 6 licensed in the state where the individual patient resides. ,

7 All issues of the managed care.

8 Health care fraud, alternative medicine, 9 complimentary medicine, have grown significantly in this 10 country. The demand for those services, those adjunct to 11 tr'aditional medical practice have grown as well. This whole 12 effort is looking at when do some of those alternative, 13 complementary practices trip over into health care fraud.

-14 When do they' replace traditional, proven medicine? When do

() 15 they rob people of dollars that they could be utilizing for 16 other purposes and so forth?

17 So, the whole arena invariably is constantly 18 changing and moving. That we're trying to work with a l 19 number of boards on.

20 Pain management guidelines. We've just developed 21 pain management guidelines that we're working with our 22 medical boards to embrace, as well as to educate physicians 23 throughout the country.

24' Physicians -- many physicians who were trained 25 longer than 10 years ago, and I'll generalize for that, were ANN RILEY & ASSOCIATES, LTD.

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202 1 trained such that using controlled substances for the

( ) 2 control of pain in chronic -- particularly chronic pain 3 situations -- was a no no. Not to do that. Well, that --

4 that had changed. Thinking has changed and medical boards 5 need to change their thinking along with that. We've done a 6 great deal of work for the last couple of years to work at 7 changing that.

8 Basically, the guidelines speak to good, solid, 9 medical practice as opposed to being into the dosage of this 10 and how many of this and so forth, but really evaluations 11 that are individualized, control over the amount of 12 medication that an individual is given, regular check ups to 13 see that the individual is having their pain relieved and so 14 on and so forth. So, it really is focussed at a good method

() 15 of practice as opposed to trying to be real prescriptive 16 about volumes of pills.

17 Continue competency of licensees is a hot issue.

18 It is, I think, for every health care regulated professional 19 these days. Keeping up to date. The professional 20 responsibility to keep up to date in one specialty and 21 discipline and so forth. But occasionally we have folks who 22 don't do that. Don't do that well. And we're looking for 23 targets in ways to have those folks trigger the whole 24 regulatory arena so that we can begin to look at those folks 25 early before they get themselves into real trouble from a

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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

203 1 regulatory perspective, fw 2 Regular license portability. Folks are moving 3 more. Physicians move much more, much like the rest of 4 society, then they ever have. And that has implications for 5 licensure and making licensure quicker, faster from state to 6 state once licensed initially.

7 Today, that tends to be a four to six month 8 process from licensing a subject to the state. Too long.

9 So, we're doing some things to try to improve upon that.

10 Public disclosure of physician specific 11 information I already talked about a bit. Much more of a 12 thrust in that arena. That the public wants to know and 13 wants to see this information. I think one of our concerns 14 is how do we provide that information in a context that 15 allows it to be more than just data elements. That allows 16 the public to take that information in and do something with 17 it that is meaningful and useful.

18 There are some ways that the Federation assists l i

d 19 medical boards. Examination enhancements. We talked about '

20 the United States Medical Licensing Exam. That exam is 21 today a paper and pencil, multiple choice exam, that is 22 offered -- each step is offered twice a year. Beginning in 23 1999 that will be available via computer. It will be 24 available, theoretically, 365 days of the year.

25 Have greater controls over it from a security ANN RILEY & ASSOCIATES, LTD.

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204 1 standpoint and so forth.

2

[) Continual enhancement of the questions that go i 3 into that exam. There are-test writing committees at work 4 on a daily basis.

i 5 There is also the expectation in the near term --

' \

6' and it could be one of those relied on computer next year, 7 computer based case situations where we'll actually_be able 8 to test folks on the basis of their judgements given a

9 clinical situation that will come up on the computer that-10 will test -- test how they would respond and take them down 1 4

11 various paths. It's the latest technology and it's been in 12 testing for quite some time and it's quite cophisticated.

13 In it's well advancement.

4 14 All licensed physicians project. This is an l() 15 effort to expand our database. Our database currently has 16 foi.cs in it who have had a board action at one time in their 17 history or have taken the examination the Federation is a 18 part of over the past many years.

19 We're working with a number of boards to expand a

20 the database to include all licensed physicians so that if 21 an action is taken against a physician who is licensed in 22 two other states we can immediately tell those two other

! 23 states that an action has been taken. And immediately, via 4

24 electronic means, close that door again, the opportunity to 25 move from state to state. So, that's a real exciting ANN RILEY & ASSOCIATES, LTD.

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(_ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

205 1 project and one that we're probably six months away form O'

G 2 completing.

3 That database, interesting enough, does not exist 4 anywhere. No one has a database of all licensed physicians 5 in this country. The AMA comes the closest, but much of 6 their information is self-reported and it also lacks some 7 physicians and it also has a number of physicians in there 8 who have been dead for a number of years. And so it's not 9 very accurate in counts as well as identifying where the 10 individual is licensed.

11 Credentials verification service. This is an 12 effort to take some burden off our member boards. It is a 13 simple repository of core credentials. Primary source 14 verified. We verify identity, educational history, exam

() 15 history and board action history. Put that information 16 together in our simple. repository. When that individual 17 next wants to get licensed in another state or go to another 18 hospital or a managed care plan or what have you, that 19 information can be really within days updated and out the 20 door and reduce that four to six month window of becoming 21 relicensed down to, we hope, a month or six weeks, 22 ultimately, with the medical board involvement.

23 Policy development advocacy. The Federation is 24 used to working with a number of boards on sort of the hot 25 issues and putting together some policy documents to help 1

i

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206 1 them do their work. That -- sort of the best thinking of

() 2 folks from medical boards throughout the country together i

3 and thinking through what's the best way to deal with this 4 kind of issue. I'll just run through a few of those by 5 topic: telemedicine, clean guard rulings, managed care, 6 impaired physicians, sexual boundaries report, uniform 7 standard aai procedures, resident licensure, to name a few 8 of those in the last couple of years.

9 And then post-licensure assessment system. This 10 is an effort to really take a hard look at and put together 11 a diagnostic system, really, of when a medical board 12 identifies that a physician'is in performance trouble.

13 Getting some complaints or what have you. And they've got 14 concerns but they can't put their hand on exactly what it )

(D

( ,/ 15 is. They can take that individual, refer them to an l

16 assessment system in which a number of tools can be taken 1 17 out of the tool box to asses what is the problem and work at 18 it. The mediation plan to retool this physician, if doable, 19 and get them back in practice before they're in serious 20 trouble from a disciplinary standpoint with the medical 21 board and have their license in jeopardy. i 1

22 There are such things -- some of the exam things 23 I've already talked about, the special purpose exam, 24 computer based case simulations and part of that clinical 25 judgement analysis. The facts of the work that's going on ht

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207 1 to really get a handle on judgement of individuals being

()

v 2 phased with patient situations. All apart of that tool box 3 that can be tailored to the individual physician, write the 4 plan of mediation, and then find the right sources to 5 provide that mediation and retest and hopefully get them 6 back into active practice.

7 That'n a quick overview and it will end there.

8 And I'd open up to any questions.

9 MR. CAMERON: Great. Thank you very much, Dale.

10 That was an excellent overview. And I would open it up to 11 anp general questions at this point.

12 I don't know if someone wants to restate at least 13 the argument that I think was made at some of the other 14 workshops we had. But basically that for at least for low

() 15 risk areas that the NRC could depend on the fact-that there 16 is a state medical board system of licensing and discipline 17 to basically cause us to defer on our regulatory scheme.

18 And I don't know if we've ever had any other -- if there's 19 been other examples like this that have come your way.

20 And I would also let myself be corrected by this 21 by you in the medical community on this particular issue 22 also.

23 And I'll just use that as a start.

24 MR. BAILEY: I guess I have two questions. One 25 for you and one for NRC.

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208 1 When a position gets into trouble. I'll use when 2

we were involved in'the medical board in California. The 3 physician in essence surrendered his license to practice 4 medicine in California and moved to Washington.

5 MR. CAMERON: DC.

6 MR. BAILEY: Actually, I think it was Arizona.

7 What happens then? Can that board then refuse to 4

8 license him or how does that work?

9 MR. AUSTIN: It's a good question and it is an 10 area of concern.

11 A couple of issues come into play. One, that 12 physician may have already been licensed in Arizona. So, by 13 relinquishing his license in one state, he didn't have to go 14 and get relicensed. He already had a license there. So, 15 that could be an issue.

[}

16 Secondly, a number of -- a number of state boards 17 are precluded from sharing information even with their 18 counterparts in another state. A physician is under 19 investigation. Makes a move. Closes down practice and 20 thinks that by making a move and going somewhere else, a l l

21 state where they're licensed, they can avoid all of that.

22 Potentially, they could. I mean, that's a possibility, I 23 suppose. But that inability to share that this is an 24 individual under investigation is a concern and one that we 25 think needs to get fixed. That due process needs to be I

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i 209 !

4 t

'.1 protected, but in the broad scheme of things we need to be I i

2 able to protect folks in the nation. And so that there 3

l ought.to be the opportunity to share that information, j 4

executive staff of the medical board to executive staff of l

, 5 the medical. board.

! 6 MR. BAILEY: Okay. And my question to NRC. I 7 know that in the past you have issued a number of orders to 8 individual physicians saying, "You shall not practice under 9 an NRC license or whatever", or "Be associated with an NRC 10 license."

11 Do you furnish a copy of that order to the state 12, medical boards that would have licensed him?

13- MS. HANEY: We don't.

t That goes -- but it is 1 14 posted with the Federal Register if we take action against a 15 physician.

But we do not, at this point, provide a copy to 16 the state medical boards.

I 17 MR. AUSTIN:

What I would encourage the NRC to do 18

, in a situation like that is to share it with the federations j 19 of what actually happened because then it's shared with all 20 medical boards so that any query on the physician in the

] 21 future is going to get that information, whereas if you 22 share it with just the individual medical board you have

23: that same problem of it may not get shared back to us 24 because it wasn't their action.

-25 MR. CAMERON: I guess Don is going to explore ANN RILEY & ASSOCIATES, LTD.

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l 210 1 doing that, right?

2 DR. COOL: Yeah. Yeah, we'll -- I think that's a V(~'T 3 very good idea that we'll need to take a look at. In some 4 cases our actions will relate to activities involving 5 radioactive material and may or may not relate to a 6 physician's practice. But if I understood what you were 7 saying, I think you might be interested in knowing about 8 those actions irrespective of if we found it necessary to 9 take that sort of action related to the privilege to i 10 practice is not exactly the same thing, but authority or 11 allow us to be on a license to be authorized physician, 12 authorized pharmacist or something like that to be involved l 13 in licensed activities for some period of time. l l

14 MR. AUSTIN: I think it would be helpful -- it

() 15 doesn't mean that there would be an automatic action by a 16 medical board, but it would be information that the medical

-17 board ought to have in hand, comparing to other complaints 18 they might be getting or other information that they might 19 have, And it would be up to them as to whether there's an 20 licensure implications.

-21 DR. COOL: Yeah, I would hate for, under a 22 reciprocal action, for that to necessarily carry an 23 automatic trip to some of the things that you were 24 discussing.

25 MR. AUSTIN: That's an interesting prospect that I

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4 211 1 don't think we've ever been looking at.

(J 2 MR. BAILEY: Well, I know we have -- we have done 3 reciprocal. Removed a physician or whatever from a license 4

or from a -- since we license the physicians to do X-rays 5 also we've removed their operator, supervisor operator 6 certificate or whatever when they've lost a right to 7 practice medicine in California.

8 MR. AUSTIN: We do have reporting that comes to us 9 from the Department of Defense and ICVA, some number of 10 federal agencies report to us in the same respect.

11 MR. CAMERON: Okay. Bob?

4 12 DR. LULL: Yes. I just wanted to point out that 13 the requiraments -- sometimes they move from state to state 14 and every state, you know, you have to renew your license

() 15 every year, every other year, and in those renewals everyone 16 I've ever seen has specific questions about whether y have I 17 had any adverse action of any type against you. And of 18 course someone could try and lie on that, but if they lie 19 it's instantaneous loss of license when they get caught, 20 unlike some people in high positions.

21 And the -- sorry. You thought you got away from 22 all that stuff in Washington.

23 And so, but basically it's very difficult, hard to 24 conceive of -- physicians are extremely regulated. Not only 25 at the license to practice medicine level, but every A ANN RILEY & ASSOCIATES, LTD.

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212 1 hospital renews. credentials and certifies credentials

/~) 2 annually and they have exactly the same question at every V

3 hospital that you practice at.

4 Most people doing nuclear medicine are at some

)

5 place based -- hospital based. Not totally out patient 6 based. Although it certainly is possible to do this in an-7 entire out patient setting only, without any kind of 8 hospital basis whatsoever. !

But these are significant

{

9 . controls. And of course anyone can write to the hospital 10 credentialing committee and everyone can report anything to l 11 the board. I think people want to get rid of charlatans and 12 people who aren't practicing high quality medicine and, 13 therefore, sharing information about adverse effects is 14 imptrtant.

() 15 16 On the other hand, we don't want to become some Nazi state either where we've got all the -- where we've got 17 spies looking everywhere and reporting everything that i

18 somebody does.

19 And so we want to try to keep some balance there, 20 I suppose. And certainly the NRC, if you're going to be 21 sharing information, you want to make sure that that's 22- authorized under your authorization to be reporting.

23 I certainly wouldn't want if a misadministration 24 happens in my shop for a three millicurie difference but 25 then ends up getting told to the licensing board and they

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i l 213 1 come back and send some guy to investigate me. l 4

()

\_/

2 There have been abuses in that area. For l

l s

3 instance, I know I remember hearing of some local hotshot

\

l 4 district attorney who is looking for, you know, making a l l

5 name for himself and he considered that if you had a 6 violation of cour r NRC license like you got a phone badge in 1 i 7 too late, which is technically a violation of your license, I i 8 that you broke federal law and he was going to prosecute and 4

9 make a big case about it and get charges against the doctor 10 and then get media coverage, you know, talking about 11 perce'ived risk and stuff.

12 So, we've got to be, you know, kind of careful.

d

- 13 Those are rare. But the fact that they actually have I i '

14 happened lets you know the concerns. And the fact that l

)()

15 16 there are lots of controls.

And this is just --

I think it's a great 1

i 17 presentation. It's another example of the tremendous j 18 controls that we already have over physicians and do we need 4

19 more. And that's the issues that the Society and ACNP have 20 been raising.

21 MR. CAMERON: Thank you, Bob. I think that's a

22- wise caution for us to consider in terms of initiating such 4

23 a -- such a program. l q 24 Roy, did you have a point that you want to make?

i. 25 MR. BROWN: No.

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214 1 MR. CAMERON: David. No , I'm sorry. Cathy. l 2 MS. HANEY: One of the things that we're proposing 3 with_the training and experience requirements is that 4- physicians as well as other professionals take an exam to 5 assess competency in radiation safet). And this is an area

.6 where hopefully we'll get.into some depth tomorrow 7 discussion.

i 8- You had mentioned that as part of the licensure 9 process that an individual has to take an exam. Do you 10 think there would be any interest on behalf -- at the state 11 board level for at least part of that exam to be questions 12 on radiation safety and use that as a mechanism for 13 . assessing competency in radiation safety as cc.rpared to NRC

.14 coming -- approving organizations to give an exam?

() 15 16 MR. AUSTIN: Well, bear in mind that the exam is an exam for the undifferentiated practice in medicine, so 17 it's not specialty focussed at all. It really is that basic 18 exam for'the practice of medicine. And my sense is that the

~

19- kinds of questions you're asking are for a very narrow group 20 of physicians; is that correct?

21 MS. HANEY: Right. And so all physicians take the 22 same exam, then?

i i

23 14R. AUSTIN: Yes. Yes. So, I think -- I don't l 24 think it would fit.

25 MS. HANEY: Okay. The second question. We are

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215 1 proposing reducing the training experience hours 2 significantly in the diagnostic arena.

0 3

Some of the questions that have been raised are public as well as really 1

j s

4 from Congress also. We've gotten an awful lot of t

l S. Congressional inquiries as to what we're doing in this area.

6 Has said that -- questioned whether this reduction in hours 7 will result in unsafe practices, authorized users not 8 handling materials safely.

9 And what we are trying to do is focus in on 10 radiation safety only and to say out of clinical competency, 11 there words to that effect, in the state it's a 12 consideration that we're published in the Federal Register 13 and there will be stated many times, I'm sure as well as the 14 final rule that NRC status as an authorized user doesn't 15 make you a competent physician.

16 But let's say during -- the rule, as proposed as 17 defined -- we have inspectors that go out to follow up on --

18 they could be following up on a medical event or they just 19 may be at the facility and uncover what we would see as a 20_ practice that just the inspector doesn't necessarily feel 21 comfortable with. For example, the individual is 22 authorized, and the authorized user I'm seeing rather than 23 20 millicuries of Magnesium administered 40 or 50 on a 24 routine basis. Because the authorized user has proscribed 25 that amount, it's outside of NRC's realm because basically ANN RILEY & ASSOCIATES, LTD.

)- Court Reporters 1025 Connecticut Avenue, NW, Suitr 1014 Washington, D.C. 20036 (202) 842-0034

216 1 we're saying our authority picks up after the

~

j 2 prescription -- after the physician prescribes the amount.

3 But we don't feel comfortable with it. I would 4 say that if it would set up that if we could take that 5, concern to the state medical board and say just that we 6 noted this. It's outside of our jurisdiction. However, you 7 may want to be aware of it. At that point the state medical 8 board may or may not choose to follow up on it. And if 9 that's the case, the last part of that is there would be 10 that mechanism to come back to NRC rather than a "Thanks 11 very much"?

12 MR. AUSTIN: Generally there is. We encourage the 13 medical boards to have that feedback mechanism and most of 14 them do, fairly explicitly, both initially as well as when

_( ) 15 the situation is finalized, whatever that final disposition 16 might be. There is communication back to that factor.

17 MS. HANEY: And then in that example -- and I kind 18 of hate to mention this again -- but one would argue that 19 what I_just said there was really no risk. Whether the 20 person got 20 millicuries or 40 millicuries it really is not 21 going to make that much of a difference.

22 Do the medical boards have some type of threshold 23 for what -- how they prioritize what they're following up 24 on, and if so can you give us a couple of examples of what 25 that threshold is?

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i' 217 1 MR. AUSTIN: Well, they -- in that particular

( ) 2 example they would -- I would doubt that the medical board 3 has any sort of threshold. What they would do is rely on

4 some of their peer reviewers. They've got a number of 5 physicians that volunteer their time in that particular 6 specialty to look at the practice and to give them 7 additional information because they as a medical board are 8 not experts in everything. They've got a lot of expertise 9 from their own particular specialties and so forth, but .

10 they're not expert in everything.

4 11 So, those cases would be looked at by peer review i i

12 folks who've had some expertise who have been looking at it 13 and trying to make some judgement and then pass that on.

14 They're not going to make a decision about whether there's s

y~m

, (_,) 15 something to be done in that particular case. That's going 16 to be left for the medical board. But they're going to 17 offer counsel about what is the standard of practice and is

, 18 that acceptable? Is that within a range? Is that outside 19 of the range? Is it a consistent pattern? All of those 20 kinds of things.

21 MR. CAMERON: Roy.

22 MR. BROWN: A general question. What -- what 23 board certified medical specialty is radiology, radiation

. 24 oncology nuclear medicine? What board is that that does 25 that?

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218 i

1 MR. AUSTIN: In terms of what?

"T 2 MS. HANEY:

[O In terms of offering the peer review?

3 MR. BROWN: In terms of quote unquote, " board 4

i 4 certification" in that medical specialty, 5 MR. AUSTIN: Well, the American Board of Medical 6 Specialties has boards that are composed of specialists in 7 those areas that develop generally examination form formats 8 and also requirements for eligibility for taking the 9 examination. The examinations are usually either written or 10 cral exams. Sometimes they're patient based oral exams. Or 11 a combination of the two.

12 Most board certification examinations are done 13 after you completed a formalized ACGNB approved training 14 program, a residency or fellowship program in that

() 15 specialty. That's something true for diagnostic radiology, 16 for nuclear medicine and for radiation oncology. They 17 sometimes have specialty areas.

18 Diagnostic radiology has a special competency 19 training one year program in addition to the standard 20 radiation training program for a special competency in 21 nuclear radiology with additional training in the nuclear 22 medicine aspects of it.

23 These all require passing the test and then you 24 are -- after successful completion of the test and 25 statements from the training program director that you've

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219 1 met the clinical competency requirements as well as r- 2 performed all the. educational requirements of the training 3 program you are then awarded board certification.

4 Nowadays most boards require recertification on 5 some annual recurring basis, usually about 10 years. So, 6 you have te show -- it's a simple test, a written test --

7 that you.still have kept up with your field and you have 8 maintained competence.

9 The licensing bureaus, on the other hand, _ require 10 that you document continuing education in your specialty 11 area. Act'ually, the required continuing education really 12 don't define what's area it's in. That's something that's l 13 actually become an issue of the JCHO where, you know, the l 14 nuclear medicine community has pointed out that many people

() 15 16 are doing continuing education generally in August through l

the-continuing education of MRCP, but may not have done any 17 continuing. education of nuclear for 10 or 20 years and yet 18 they're claiming that nuclear medicine -- have not been 19 keeping up.

20 So, I think JCHO is looking at changing that and 4

21 saying you have to be.specifically educated in the areas 22 that your practicing, in the specialty area in which you're 23 . practicing, but that hasn't followed yet. But I think they 24 were very interested in looking at that.

12 5 So, there are all these controls. In terms of i

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220 1 peer review, you would probably go to the local specialty

/~'i 2 organizations like the Society of Nuclear Medicine, American O 3 College of Nuclear Physicians. I know the American College 4 of Nuclear Physicians has worked together with the state 5 licensing bureau in California and I think with the 6 department of Radiological Health Bureau in setting in --

7. applying one of their standardized, on site inspection '

8 programs that they have to evaluate the overall clinical i

9 concern that's happening. And they have a program -- a 10 certification program that's in place that'will come out and 11 do a comprehensive evaluation of your program, total 12 program, beyond just radiation safety but including that.

13 In terms of the practice standards of the profession. And 14 . certify the program.

() 15 If it passes the requirements there are a lot of 16 written documented requirements that are used in the 17 evaluation. And then we can do it as a written format every 18 two years and then on the third year in a recurring cycle 19 you get that certification.

20 So, there are a number of programs. There are 21 many programs in this range that are being developed by 22 other professional organizations now as this is important.

23 So, there are a lot of tools available.

24 MR. BROWN: Is it possible for one of those 25 medical specialty boards to set up a standard that says when s ANN RILEY & ASSOCIATES, LTD.

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4 221 1 is a medical event? And that responsibility would be 2 retained by the Medical Specialty Boards?

3 MR. AUSTIN: You mean to define what a medical 4 event is?

5 MR. BROWN: To develop the same approach they 6 have.

7 MR. AUSTIN: Well, there are standard right now 8 for what the practice, you know, should be. And one of 9 those practices is that you give the appropriate dose to the 10 right patient. That's already involved. And so if you fail ~

11 to do that you're not practicing up to standard.

12 And in terms of continuing quality assurance 13 programs that are required for a hospital, hospital 14 facilities, you need to be documenting that you're following

[O

\ 15 standard practice and how often you deviate from that. And 16 those are things that you use to impress your JCHO inspector 17- that you're really keeping on top'of things.

18 MR. BAILEY: Here's what I'm asking, if we broaden 19 that standard to a point where if you follow the standard 20 you could be in general licensing.

21 MR. AUSTIN: Well, I got a big nothing at break 22 time, although the general license -- I'm a little clear on 23 that one.

24 But on the other hand I think that professional --

25. the boards are probably not the right vehicle for that. But ANN RILEY & ASSOCIATES, LTD.

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222 1 I think the professional societies are capable of providing

() 2 3

that with their ongoing certification programs that they have in place. 1 4

And of course that's one of the difference between 5 the NRC and its rules as they do have that man in the back 6 who represents the outside inspection group that comes in 7 unannounced and says, "Well, I'm from the NRC" and does a 8 detailed inspection of all~your records. The state 9 licensing boards don't have unannounced inspections of a 10 doctor's practice. It's all pass of receipt of information 11 and --

12 MR. BROWN: Which might trigger -- which might 13 trigger an investigative --

l 14 MR. AUSTIN: It might trigger. Yes. But there's

()

i 15 no routine investigative things going on. But I think the 16 threat of that trigger thing is something that really helps 17 maintain physicians who might be on the edge stay in line.

18 MR. CAMERON: Thank you. But I think that Roy's 19 point about could you use some of the existing 12 0 infrastructure in a medical profession to -- in combination 21 with some type of -- call it a deregulatory scheme to -- to 22 make NRC feel more comfortable with that regulatory regime?

23 And I guess before we get down there, I guess at some point 24 I'd like to get a clarification about it. We've been 25 talking about -- Cathy mentioned this morning the standard

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223 1 of practice and threw in standards of care. And I'm not

(~*) 2 sure what the difference between those are.

%J 3 But Dale was talking -- you mentioned that there 4 iu an investigation by the board later to appoint some 5 physicians from that specialty to see if the standards of 6 practice were violated.

l 7 And I think you said something about this, it sets l 8 the -- what are the standards are practice? How are they --

9 how are they set and how much application does it have to 10 preventing the types of things that the NRC is -- is i

I 11 concerned about? I l

12 Think about that question and let's go down to ]

13 Rich for his comment.

1 14 MR. HEUSER: Along the lines of disciplinary

'O

()

15 action or violations, you're asking a good question because 16 the reality of it, the way to works is that it's an in l 17 hospital situation.

l 18 For instance, if there's anything done that is l

19 beyond the range of standard care, an outcome, for instance, 20 that patient has a lung scan or has a pulmonary tertraminie 21 (phonetic) and had a complication and died. That goes to 22 the QA board of that subspeciality if you will, that would 23 probably be in radiology purview or cardiology if the 24 cardiologist was doing it. And that goes through that l 25 organization.

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l 224 1 R So, from the standpoint of if there is something !

("' 2 going on that'that would be brought to the initial QA who --

V) l 3 which in general is -- that information is information at 4 the hospital level. That doesn't go to to the state board.

5 If there's a problem and a physician gets disciplined, that ;

6 goes to the state board. So, it's not really the specialty 7 board.

8 One of the ways we're trying to effect a change i 9 with that is our concern in the American College of 10 Cardiology is the radiation safety even though the 11 brachytherapy for a nonspecialty is not improved yet. In 12 our specialty boards for interventional cardiologists, since 13 those positions doing intervention cardiologists are the 14 only ones that would be doing interventional, if you will,

() 15 brachytherapy. As part of the certification for 16 interventional cardiology an important aspect of that is 17 going to be radiation safety. And it is possible that that 18 radiation safety, from the stand point of a specific 19 specialty, may take a different level of reporting than you 20 normally have with your normal QA board.

21 MR. CAMERON: Thank you, Rich.

22 Bob?

23 DR. LULL: Yes. Just one thing. Just to carry on 24 with your comments about interventional cardiologists. At 25 least in my hospital -- in most hospitals, the i

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225 1 interventional cardiologists are actually the ones who have 2

the radiation exposure because of all the velocity, which is t

3 of. course not an NRC prerogative whatsoever. But the fact

4 is in terms of the amount of radiation exposure that's 5

occurring, both to the practitioners and to the patients, 6 it's actually happening with X-ray generating devices. And 7

the brachytherapy sources that they would be using would be

'8 relatively minor risks compared to the -- times that are 9 needed. And basically that's a risk of benefit ratio. And 10 those risks are still very small compared to the profound 11 benefits they are offering to the patients. So, they do 12 that. It's just another example of how in medicine you use 13 a best benefit analysis to, you know, make patients' lives 14 better. I hope I'm not speaking out of turn but that 15 certainly is true and it's a factor and it brings us back to 16 remember that we're only regulating -- we're only talking 17 about regulating just a portion of the radioisotopes that 18 are used in clinical practice. All of these other 19 radioisotopes are still present, as a matter of fact. And 20 I'll just leave it at that.

21 MR. CAMERON: Rich, do you have anything other --

22 anything on that?

23 MR. NEBLETT: To rephrase the question by Roy as I

~

.24 understand it as that don't the professional medical groups 25 have established procedure qualifications that are normally ANN RILEY & ASSOCIATES, LTD.

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l i 226 l 1 used for patient selection and isn't that criteria --

2 patient criteria -- procedure criteria -- a logical place to l

()"'s 3 do risk assessment of procedures for patients?

l 4 MR. HEUSER: In fact -- in fact, again, all I'm 5 trying to say that in general that's for a hospital level.

l 6 When -- when a hospital is being analyzed for certification, 7

we have to make sure that we show our documents for who's a 8 candidate for a lung scan, who's a candidate for a coronary 9 artigram (phonetic), who's a candidate for a stress valium, 10 I mean those -- if those criteria -- if that's not set up in 11 place in a hospital or if it's not been followed then that's 12 a violation and that would get the first QA committee in the 13 hospital and then to the state board licensure. So, that --

14 that is already in place. I 15 f~)

v MR. CAMERON: Okay. Thank you. Cathy?

16 MS. HANEY: Your question is vno sets the stands, 17 though. Who set the guidelines. Ara it's ultimately the 18 professional societies. If you look at, say, the Society of 19 Nuclear Medicine. The Society of Nuclear Medicine had a set 20 of published practice guidelines for the Nuclear Medicine 21 Procedures. They're on the Internet. They're published and 22 available to any practicing physician that sets a standard, 23 set the criteria for how the exams are done.

24 Along those same lines there are the standards for 25 nuclear medicine technologies, which was your concern. What

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l 227 1

1 they can do -- the appropriate way to do it. These again 2 are published. They.are on the web site and available for O' 3 all nuclear medicine technologists. And it's something that 4 we're pushing very strongly for uniform competency across 5 the nation. There is -- there are too many states right now 6 that aren't licensed or whatever. And we are looking 7 towards a national licensure bill. !

8 But again, the standards are routinely set by the 9 professional organizations because that's the organization 10 that deals with that specialty. !

11 MR. HEUSER: The thing about that is that makes it !

12 difficult for some hospitals not to follow its guidelines.

13 And with rare exception -- and the exception would probably 1 14 be in areas that are under served where perhaps the

/N 15 guidelines would be looser. But in general the Society set V

16 the guidelines for us and we put the statement in the l 17 hospital -- in the hospital bylaws, so that it's very clear 1 l 18 and most are followed. And I'd say the only exception are '

19 probably the hospitals that are under recert, perhaps l 20 MR. CAMERON: Go ahead, Bob.

21 DR. LULL: Do the -- I think the point -- a 22 corollary point that's kind of somewhat important here is L

L 23 that when you're talking about practice of~ nuclear medicine L i 24 or radioiso'.: ope usage within a hospital setting there are a 25- lot of extra controls that'are in place. And in a sense you ANN RILEY & ASSOCIATES, LTD.

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228 1 might almost end up really deregulating a lot of it's 2 occurring in the hospital compared to, for instance, if 3 you're in an outpatient setting where you don't have a whole 4 lot of controls.

5 And it will say -- basically what you're going to 6 have -- are really quite generic in their approach to 7 whether or your. violating -- you're violating the Medical 8 Practice Act. And really aren't very oriented around things 9 like radiation usage and radiation safety and appropriate !

10 patient application of radiation. That's really not a --

11 that's very grossly and actually -- bad on.the patients, 12 you're probably not going to get the -- detect the new line.

13 So, in a sense you want to have much larger 14 regulations in the out patient environment than you have in

() 1 15 the in patient environment because hospital environments l 16 already have hug amounts of controls in place that maintain 17 safety.

18 MR. CAMERON: Okay. Thanks, Bob, Dale, do you 19 have a comment?

20 MR. AUSTIN: Just I would agree with Bob's 21 comments because one of the areas of the medical boards I'm 22 particularly concerned abou; today is there are more and l 23 more physicians who are practicing without hospital 24 affiliations and those folks are our concern because there 25 aren't peers sort of side by side able to look at their

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229 1 standard of care. And that is an area of concern that we 2 see growing because of the thrust to more and more 3 outpatient kinds of services, i 4' In the past that was basically unheard of. l 5 Physicians all had a nexus to a hospital. Today that's !

l 6 changing. Not changing by huge numbers, but it's changing. !

l 7 And those are individuals that are our concern. !

1 8 MR. HEUSER: Yeah. I don't know what state you j; 9 guys are living in, but we take outcome analysis of all 10 these places. We can't practice medicine in any facility, g 11 in patient or out patient, without our outcome information.

12 Everybody.knows it. Medicare knows it. It's not as 13 subterfuge as you might be concerned about. It's wide open, 14 'whether it's in patient or out patient. l

) 15 MR. CAMERON: Okay. Thank you. Ed?

16 MR. BAILEY: Cathy, is that -- the guidelines and l 1

17 all that you were talking about, are they available on the !

18 Society of Nuclear Medicine Technologists web site, the 19 southern California one?

l 20 MS. HANEY: No. It's on the Society of Nuclear 21 Medicine's web site. The national organization.

22 MR. BAILEY: Okay. And the other thing that I 23 wanted to mention was getting to this sort of generally 24 lic :nsed concept. It's almost sounding like we're drifting 25 to how we would do a hospital X-ray registration to a large ANN RILEY & ASSOCIATES, LTD.

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230 l'

extent-except maybe making them get it before hand, as with 2 a license. Because basically what we do is we give it to 3' the institutioa and the institution has the responsibility 4 for the radiation safety program. And then we have s

5 requirements that -- well, in California -- that the 6 physician.have their operator supervisors certificate.

7. We presently' license nuclear medicine 8 technologists. But pretty much if you're -- if you're 9- already board certified then it's sort of a gotcha. You 10 send your money in. That's all. You send your money in and s

11 your name and address and you get your state certification.

12 I think the important part of that is from a 13 radiation regulatory stand point is that we have direct 14 control over one continued to practice the nuclear medicina

() 11 5 or use of X-rays in the state as having to wait on the 16 professional organizations to take some action.

17 So, there is the radiation regulations. We have 18 direct control there. We've talked about this in our 19 Nuclear Medicine Counsel of having the nuclear medicine ,,

20 physicians, whether they be cardiologists, would get some 21 . sort of certificate similar to what we do with the X-ray 22 supervisor or operators and then we wouldn't go and make a 23 lot of these steps of adding people to licenses and removing 24 them and on and on and on.

25 MR. CAMERONi Okay. That's something to consider 4

i

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231 1 in thinking about that type -- e. hat type of scheme.

f) 2 Melissa?

V 3 MS. MARTIN: I was just wondering, you're talking 4

about recognizing professional societies, is there any 5 consideration -- I guess as a background I'd reiterate 6 what's been said to a certain extent. JCHO is recognizing 7

the fact that, like American College of Radiology, has 8 established standards of practice. And if you obtain an 9

accreditation from the ACR basically that is the blessing, i 10 in other words, you are following a recognized standard of i 11 practice.

12 Is there -- could there be consideration from the 13 NRC or -- and agreement states to do the same? In other 14 words, if you have already made a commitment as a hospital

(~D 15 that you are following established standards of practice, V

16 then that really would satisfy the criteria.

17 And I would just reiterate as a consulting 18 physicist I think what you're seeing is as the push is i 19 developed to more and more out patient settings, the in 20 hospital practices are not the potential problem. It is the 21 push for the outside facilities which have very little 1 I

i 22 control over -- other than that, it's a wide open practice l as to who comes in and does the procedures.

l 23 You don't have l 24 a physicist on board. You don't have the same kind of l

25 control that you certainly have in, say, a JCHO accredited '

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k 232 or ACR accredited standard of practice, you know, radiology

.2 nuclear medicine facility.

CJ')

3 MR. CAMERON: Thank you, Melissa. Charlie, do you 4 have a similar?

5 MR. SHOWAL'2ER : I was going to make a similar 6 comment. First of all, the ACR also has named standards of 7 practices that are also available on the ACR when site'.

8 But in addition to that, the college, I believe, 9

sees a mess in its future in terms of accreditation and 10 accreditation programs, just as Melissa was talking about.

11 One recently got recognized by the JCHO. I believe it was

'12 in radiation oncology. But there are others that are either 13 in the development stages or -- or currently have been 14 running for years. Probably the best known is in P

15 mammography.

16 But some recognition of the accreditation program 17 in addition to standards of practice seems like another 18 possible area to think about in deciding how to regulate 19 nuclear medicine. ,

20 MR. CAMERON: That's good. As I mentioned ;

21 earlier, we are going to get not only the Joint Commission 22 representative and also Dr. Grant Bagley from PICVA at the p 23 . Washington meeting. I'm trying to figure out how to perhaps 24 put a finer point on what a proposal might look like in this 25 area in terms of a -- let me just call it an alternate

'[

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i 233 ;

1 regulatory regime for the NRC to consider.

2 5

We can wait until we get to the October meeting or

\- 3 we can see if some people might be willing to try to provide 4 some more details on that before we get that far -- that far 5 down the road.

6 Charlie?

7 MR. SHOWALTER: Since it's come up now let me just '

8 say that this is something that we had' intended to broach at 9 some of the later meetings and so we fully expect to -- in 10 some kind of suggestive framework in this area.

11 MR. CAMERON: And will this be coordinated with 12 other interested firms also?

13 MR. SHOWALTER: Absolutely.

14 MR. CAMERON: Okay. Well, I wouldn't leave that 15 as a task. I think that would be real, real useful thing to 16 do.

17 And I also mentioned earlier that the NRC is I 18 holding a one day workshop in Chicago on September 1st on 19 the whole issue of how the NRC participates in what are 20 called' standards development organizations traditionally as 21 in any triple E, it's very reactor focussed, but the intent 22 is to look at standards across the board that the NRC might 23 use. And we are going to have the -- someone from the 24 Health Physics Society there. Is it the N7 or N14? N13. N 25 -something.

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1 234 1 This is meant to capture most of the materials --

! 2 standards that are used in the materials area. I'm k-3 mentioning this because I don't know if there any of you who l 4 would like to attend or have someone from your organization 5 attend this.

6 But one of the driving forces here is also the 7 whole idea of when should the NRC adopt' industry 8 initiatives. Okay. And I think that the Staff has 9 mentioned in the ---in the policy statement that the 10 Commission has in the draft policy statement, the new 11 national legislation that by encouraging agencies to adopt 12 agency standards. But there may be some useful things that 13 people may be interested in in there. And if you need more 14 information I can get it.

~'l (J

15 16 Don, did you want to say anything on this area before we close up? All right.

17 Well, we're supposed to adjourn at five and I 18 guess does anybody in the audience have anything on this 19 particular issue?

20 Yes, sir?

21 MR. HOLMES: John Holmes at Stanford University.

22 MR. CAMERON: John, would you mind coming up to 23 the microphone? Thank you.

24 MR. HOLMES: I just wanted to add my support of **

25 the idea of incorporating a standard -- alternate l p/

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235 1 standards -- regulation. But I'd like to have this -- a t ). 2 clarification for authorized. Usually you have a potential 3 list or a program that was certified by, recognized --

4 agency. I approve of having a license -- detailed license i

5 by the NRC. It would be very helpful in the hospital. It 6 would eliminate a lot of the redundancy -- and I think

7 that's what we're really trying to avoid, a lot of l 8 redundancy in oversight. If it serves a regular. purpose, it 9 brings a lot of energy and a lot of resources into it.

10 MR. CAMERON: Thank you very much, John.

11- David?

12 MR. NICHOLS: David Nichols, ASFPSNM. I want to 13 reemphasize the comment that Dale made about what they do 14 when they get into a situation of trying to determine if a l (j

( ;15 position has deviated from the standard of care. And it's 16 the use of peers that are in the practice that then look at 17 the actions taken by a physician to determine if that 18 deviates from the broad standard of care.

19 There are a couple of examples that I can think of l 20 in our C regulation where they probably would have 21 benefitted from that sort of review. That is in the area of

-22 patient notification where right now NRC requires that 23 written instructions be given to some certain individuals.

1 24 The professionals society strongly encouraged NRC l 25 not to get that specific. And I imagine that if you

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236 i

l 1 forwarded that to the state medical board and saying here's I

I

/"'i Q,)

2 an instance where a physician did not give written

\

3 instructions. The peers would say, "Well, that's okay.

I 4 It's not a standard of care that you provide written l

l l

5 instructions to a patient, simply that you provide j l instructions."

1 Another example would be describing doses in a l 8 range -- I know that NRC does not allow physicians to 9 prescribe doses at a range of 20 to 30 millicuries. So, as 10 long as it falls somewhere between there, you're okay. Yet, 11 if you take that through a peer review process then those 12 physicians would probably say, "Well, that's fine. That's 13 within the standard of practice and that is not a 14 violation."

t

) 15 Here are clear instances where the NRC would 16 benefit from an investigation and enforcement action asking I 17 a group of peers whether this is something that represents 18 significant harm to public health and safety. Nine times 19 our of 10 I would imagine that the regulations would not be 20 interpreted if they were violated as a patient protection 21 and public health and safety.

22 That peer review process does not exist now. And 23 yes you have an advisory committee of medical people on 24 there and you use medical consultants in some cases, but 25 of ten time your n.edical consultant said there was no harm '

)

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237 1 involved to the patient, there's probably no deviation from 2 the standard of care, and yet it's still an enforcement 3 action.

4 MR. CAMERON: Okay. Thank you, David. Maybe 5 we'll have an opportunity to explore that when we get to the 6 compliance enforcement section and we'll ask Joe DelMedico 7 to give us his thoughts on that.

8 And I think that going to Dale, the fact that a 9 regulation was violated is not going to be necessarily 10 dispositive on what the recommendation is made, what 11 recommendation is made to the medical board by the peer 12 reviewer.

13 MR. AUSTIN: That's right.

14 MR. BAILEY: There is one nuance to regulations

() 15 16 being broken. In some states, including California, the violation of a regulation is a misdemeanor. So, one would 17 have to be careful on how those were reported. We don't 18 routinely treat them as misdemeanors. We don't take every 19 violation and go to court with it, obviously.

20 MR. CAMERON: But you could, if you wanted to.

21 MR. BAILEY: If you get right down to 22 regulating -- I mean, if we get somebody that we're really 23 mad at, then we go to court or whatever and they become --

24 MR. CAMERON: In California.

25- MR. BAILEY: Well, in fact, the very famous or

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l l 238 l

1 infamous case where a local university was taken by a local j

()

\m) 2 DA in a series of things that we found during inspection and 3 taken through the court system for several years. And every 4 time we would find something that we cited as a violation

! 5 after that he was like taking it and willing to tack it home l 6 and was actually trying to send people to jail for what we 7 would normally consider regulation violations as opposed to 8 'more serious violations of the law.

9 MR. CAMERON: Thank you. Okay. We start tomorrow 10 at 8:30 and we're going to start right off with the 11 compliance section. And I'd just like to thank all of you 12 for your participation today. ~The types of things that Ed 13 was mentioning there is a good example of where you get the 14 collective wisdom of a group together you can find out a lot lO V 15 16 of things.

I'd particularly like to thank Dale Austin from l 17 the Federation for coming out and giving us that 18 presentation and enlightening us on some of this stuff.

19 So, thank you. Have a good night. We'll see you 20 tomorrow.

21 [Whereupon, at 5:18 p.m., the meeting was 22 recessed, to reconvene at 8:30 a.m., Thursday, August 20, 23 1998.]

l-24 25 l

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REPORTER'S CERTIFICATE This is to certify'that the attached proceedings p before the United States Nuclear Regulatory Commission in

'i s

, the matter of:

NAME OF PROCEEDING: PUBLIC MEETING: PROPOSED REVISION OF PART 35 AND THE NRC'S d

MEDICAL POLICY STATEMENT i

CASE NUMBER:

{ ' PLACE OF PROCEEDING: Saa Francisco, CA were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear j Regulatory Commission taken by me and thereafter reduced to

typewriting by me or under the direction of the court

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reporting company, and that the transcript is a true and accurate record of the foregoing proceedi s.

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