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Transcript of Advisory Committee on Medical Uses of Isotopes Meeting on 951018 in Rockville,Md.Pp 1-224/280-307
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Issue date:	10/18/1995
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@fBelal Transcript of Proceedings

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Title:

Advisory Committee on the Medical Uses of isotopes (ACMUI)

Docket Number: (not applicable)

Location: Rockville, Maryland Date: Wednesday, October 18,1995 M

Work Order No.: NRC-363 Pages 1-224/286-dO7 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 O (202) 234-4433 1

i 9eo41gg193980402 l 20 62FR4120 PDR

i r DISCLAIMER !

~ This is an unofficial transcript of a meeting of the Advisory Committee of the Medical Uses of Isotopes, of the United States Nuclear Regulatory Commission, held on October 18 and 19, 1995, at the U.S. Nuclear Regulatory i l

Commission, Two White Flint North, Washington, D.C., 205S5. All but one I session was open to the public. One session of the meeting was closed to the public to' avoid the disclosure of it,'ormation that would constitute an )

unwarranted invasion of the personal privacy of a physician whose training and experience was reviewed by the ACMUI in connection with the physician's application to be an authorized user under a license authorizing medical use of byproduct material. l O This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.

The transcript is intended solely for general informational purposes.

As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Commission in any proceeding as ;

l the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.

O

l 1

1 i

UNITED STATES OF AMERICA l

2 NUCLEAR REGULATORY COMMISSION j

3 ++++4 4

ADVISORY COMMITTEE ON MEDICAL 5

USES OF ISOTOPES (ACMUI) 6 +++++

7 WEDNESDAY, 8 OCTOBER 18, 1995

)

9 +++++

10 ROCKVILLE, MARYLAND 11 +++++

12 The Advisory Committee met at the Nuclear Regulatorf 13 Commission, Two White Flint North, Room T2B3, 11545 I

14 Rockville Pike, at 8:30 a.m., Barry Siegel, Chairman, 15 presiding.

16 MEMBERS PRESENT: l 17 BARRY A. SIEGEL, M.D., Chairman 18 DANIEL S. BERMAN, M.D., Member 19 WIL B. NELP, M.D., Member i 20 ROBERT M. QUILLIN, Member 21 JUDITH ANNE STITT, M.D., Member 22 DENNIS P. SWANSON, M.S., B.C.N.P., Member 23 LOUIS WAGNER, Ph.D., Member 4 24 DAVID WOODBURY, M.D., Member (O 25 JUDITH I. BROWN, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1333 RMODE ISLAND AVENUE. N W.

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1 Also Present:

2 I

D 3 Larry Camper 4 Josephine M. Piccone 5 Donald Cool 6 Sally Merchant I 7 horreTaylor 8 Manuel Cerqueira 9 Cheryl Trottier 10 Stewart Schneider 11 Trish Holahan 12 Cathy Haney 13 Jim Smith l

14 Jim Clark l l

15 Mattew Combs 16 Susie Hoffme.n 17 Dennis Sering j 18 Evelyn Watson I 19 Peter Almond 20 Mel Griem i I

21 Carl Paperiello 1 22 Patricia Rathbun i

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1 AGENDA l

t n 2 Acenda Item Eggg 3 Director's Comments 4 4 ACMUI Review of Training and Experience Exemptions 19 5 Sally Merchant 1

6 Update on Rulemakings and Guidance 78 i

7 Intravascular Brachytherapy Issues 132 8 Jim Smilth 9 Exemption for Commercial Distribution for 10 in vivo testing 174 11 Inspection Manual 1360 Role of Medical Consultant 203 12 Dennis Serig s 13 Manual Chapter on Patient Follow-up 218 I

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14 Report on Subcommittee Review of Draft 15 Licensing Modules 280 16 Barry Siegel 17 Status Report on National Academy of Sciences Study 18 of Medical Use Program 300 19 Patricia Rathburn 20 21 22 i .

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1-P-R-O-C-E-E-D-I-N-G-S 7g 2 (8:36 a.m.)

N- 3 MR. CAMPER: Good morning, ladies and 4 gentlemen. I am pleased to welcome you to Rockville, 5 Maryland and to the NRC headquarters for this public l l

6 meeting of our advisory committee on the medical uses of '

7 isotopes. I am Larry Camper. I am the chief of the j 8 Medical, Academic, and Commercial Use Safety Branch, and I i j

9 am the designated federal official for this advisory 10 committee meeting.

11 This meeting -- this announced meeting of the {

l 12 advisory committee is being held in accordance with the 13 rules and the regulations of the General Services 7_

s_ 14 Administration and the Nuclear Regulatory Commission.

15 This meeting was announced in the Federal Reaister on the 16 25th of September, 1995, and that notice stated that the 17 meeting will begin at 8:30 a.m. and we're just a little 18 bit late.

19 The function of the advisory committee is to 20 advise the NRC staff on issues and questions that arise in 21 the medical use of byproduct material. The committee 22 provides counsel to the staff but does not determine or 23 direct the actual decisions. The NRC solicits the 24 opinions of counsel and values the opinions of this

( 25 committee very much.

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Tha staff requests that the committee reach a 2 consensus, if possible, on the various issues that will be 3 discussed today but also values stated minority or 4 dissenting opinions. And we ask that you would clearly .

5 articulate those dissenting opinions as we discuss the 6 specific agenda items. Our agenda today is once again 7 full and I would request that you make your comments 8 specifically germane to the topic under discussion and 9 make them as succinct as possible so we can conduct as 10 much business as possible.

11 As part of the preparation for this meeting, I 12 have reviewed the agenda for members financial and 13 employment interests. I have not identified any conflicts 0

14 that Lased up:n the very general nature of the discussion 15 that we're having at this time. Therefore, I see no need 16 for any individual to recuse themselves from the 17 discussion. However, if during the course of our business 18 you determine that you may have some conflict, please i

19 state that for the record and recuse yourself from the 20 discussions.

21 What I'd like to do at this point before 22 introducing the committee members for the record and so 23 forth is allow Dr. Donald Cool, the division director for 24 the Division of Industrial and Medical Nuclear Safety, to 25 make some comments under the director's comments.

b '

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1 DR. COOL: Thank you, Larry.

2 I'm pleased to welcome you back once again for 1 3 another meeting. For some of you, it was just like you 4 were'just here. Over the last few weeks, there were a 1 5

number of subcommittee activities working on various 6

modules and activities related to some of our training. I 7

was very pleased that the ACMUI was able to undertake that 8 sort of endeavor and get into some of those details and l

9 provide us some assistance with that. So let me express 10 my thanks to you for those special efforts and the work 11 that was done.

12 I know one of the questions that was raised at 13 that time or by some of those subcommittees was how does

\ 14 this now then fit into the overall structure with where 15 the office of Nuclear Materials Safety and Safeguards is 16 headed in terms of regulatory guidance and that process.

17 You have probably heard at least rumor and innuendo, if 18 not more so, associated with what has turned out to be a I

19 massive undertaking on the part of my staff to essentially l 20 re-engineer the licensing process for materials licensees.

21 At a first, very superficial look, that seems, well, 22 relatively simple. You go in and see what you're doing 23 now. You see how you could do it better and you go and 24 institute those changes. Unfortunately, as with all j i

V) 25 things, it's not nearly that simple, although we have been j NEAL R. GROSS COURT REPORTER $ AND TRANSCRSfR$

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continuing to move through a rather substantial proccas

- 2 which will continue over the next year or so. !

3 one of the pieces of that process is a 4

division of the whole way in which the guidance system 5

that we use and put out for licensees and ourselves to use 6 is formatted and organized. In some cases, it will also

{

i 7 result in new guidance or changes to the guidance that 8

exists there because of things which are outdated, things 9 which have been hanging around in drafts for long periods j 10 of time, and a variety of circumstances. That process is I

11- ongoing and in fact I will leave from here to go and meet i 12 with a management review team of NRC managers from the 13 regions and headquarters that will be reviewing the 14 efforts to date on that licensing guidance activity.

15 one of the things we have attempted to do is 16 to build into that whole development process and outlining 17 process a safety analysis of the system. The NMSS 18 guidance for materials has grown up over a long period of 19 time, 20 to 30 years. And with anything that sort of 20 grows and evolves over the course of time, you get some 21 interesting discontinuities and otherwise. And so we l l

22 undertook a systematic analysis of the safety implied by I 23 the guidance activities and have now integrated that in i

24 the outline. I 1

25 Fundamentally, the new guidance will deal with NEAL R. GROSS count unmas ao ramscamas !

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8 1 two areas. That kind of information which all, or at 2

least substantial segments, of the licensee community 3 needs to know. Fundamentals with regards to radiation 4 protection. How to apply for a license. Securities of 5 materials. Some of those sorts of things. And then from '

6 there, move into specifics for particular classes and 7 types of licenses. So you can envision, and I don't care 8 'whether you draw the pyramid upside down or right side up, 9 but moving from that which is very general to that which '

10 is very specific such that if you are a particular 11 licensee, and I'll pick radiography just to stay out of 12 any.of the groups that are here today. But if you were a 13 radiographer and you asked the NRC, what do I need to know 14 about this particular license. Or, if you were going to 15 do mobile brachytherapy, or if you were going to 16 intervascular brachytherapy, or any of a number of things 17 that you have on your agenda today, you would be able to 18 extract from that general and specific guidance that ;

19 particular list of things that was directly applicable to 20 you. We hope to have it all done electronically.

21 As a result, the efforts that you folks did in i 22 the subcommittee, and the ongoing efforts with a number of !

23 these modules, will fit, I believe, very nicely within i 24 this pattern because those are in fact the detailed 25 specifics that will apply to any little pra .cular class NEAL R. GROSS count apomias aNo raaNecansas 1333 RM00E ISLAND AVENUE, N.W.

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of licennoo cctivities, and be dependant upon the other 2

more general information which other people need to know.

\_,/ 3 I wanted to provide you with that brief 4 synopsis. Later this afternoon we're going to be talking 5 a little bit more about the re-engineering effort in 6 general. But it is taking considerable amount of effort 7 and time.

8 There are a couple other things that I just 9 want to sort of note to you and then let you proceed on 10 your way. You have a couple of topics on the agenda that I 11 believe are particularly important. One of them dealing 12 with emerging technology and use. That is, the l

,, 13 intravascular brachytherapy, which raises a number of 4

( \

\, 14 questions with regards to ink packs, appropriate 15 supervision, training, experience requirements, and 16 otherwise for kinds of activities and perhaps kinds of 17 individuals who have no previously been using sources, at 18 least in this particular type of modality for treatment.

19 So, that is something which I think bears considerable l

20 degree of attention because we are still on the front end 21 of it enough so that we do not have to catch up. We can 22 actually stay even with the power curve in this particular 23 case.

24 One of the other things you have on the agenda Oi 25 is a discussion associated with medical consultants and td NEAL R. GROSS count aponrEns aoinescamEas 1323 rho 0E ISLAND AVENUE, N W.

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how thoca consultants work in particular circumstances,

- 2 what kinds of information that we might be looking for.

x_- 3 And to try and get some clarity with what I've discovered 4

over the past six months tends to be not necessarily very 5 clear. And in fact, would almost lead you to believe that 6 in order to be able to do your job you had to deny the 7 request to act as a consultant because it was of 8 relatively minor significance. Rather than making the 9

statement for the record that based on the information 10 that you had, this was of minor significance and being 11 done with the job. It's a very strange perception 12 although maybe perhaps you get to the same end point.

,., 13 And so, I think that discussion in terms of

\m / 14 how you function as consultants, both you here on the 15 ACMUI and of the other consultants that the agency retains 16 for use in specific medical situations. That will be a 17 very interesting discussion and hopefully we can get a 18 little better clarity with regards to the sorts of things 19 that can and should be done and the proper way to 20 represent what was accomplished in that sort of thing.

21 Lastly, I want to simply mention the incidents 22 that have been going on over the past few months. They 23 are obviously not medically related in the sense that they 24 involve the treatment of a patient with radioactive (n~) 25 materials for diagnosis or therapy.

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that what will coma out of all of the efforts associated 2

with the NIH contamination event where a female individual i )

'O 3 who was in fact pregnant at the time received internal 4 contamination of phosphorus-32. There's been a great deal 5 of publicity just of late associated with that and an 6

event which the commission found out about just this week 7 which was very, very similar at Massachusetts Institute of 8 Technology. Again, phosphorus-32 internal contamination.

9 Amounts of material at or very close to the regulatory 10 limits for occupational exposure. Raising questions 11 associated with the appropriateness of the rules and 12 guidance that we have in place for security of materials.

,_ 13 For functioning and authorities of radiation safety

)

(/N-s 14 officers. For reporting and record keeping requirements.

i 15 And I bring these to your Ettention mostly for 16 your information because there may well be a ripple effect i 1

17 that goes well beyond the simple broad scope license.

18 Most of these broad scope licenses are liable to have 19 medical problems associated with the problems -- programs 20 associated with them as well as, perhaps, research 21 reactors and other activities. And so, I would like you 22 to at least have that in the back of your mind. If there 23 is input that you might wish to make at some point during 24 the conference, we'd be happy to receive that.

( 25 I have a minute or two to answer questions and NEAL R. GROSS COURT REPORTERS AND TRANSCRWERS 1333 RHODE ISLAND AVENUE, N.W.

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1 12 1 try to kosp you on schedule.

s 2 .Barry?

3 CRAIRMAN SIEGEL: I No specific questions. I'm '

l

<i quite interested in.your last comment and I wonder what we 5 can do to keep you all from'over reacting. Because I am 6

very concerned that extremely stringent security measures -

7 in reaction to what appear, at least initially, to be .

8 extremely unusual events, can really be very disruptive, 9 not only of the daily' conduct of' business in a research 10 university, but.of the practice of medicine in a way.that 1

11 it can become very, very difficult to just conduct ones 12 business.

I 13 DR. COOL: That is something that I am also s '14 concerned'about. But you are right. That th'e' pair of 15 incidents, being as they are and coming with the timing i 16 that they have, has resulted in a significant agency 17 response. I should note that the NRC_ yesterday afternoon 18 ' initiated an incident investigation team, it's highest 19 investigation team effort which reports directly to the 20 executive _ director for operations, to review the MIT 21 action. We have been tasked by the chairman to review the i

12 2 regulatory aspects and the application of our regulations 23 -coming out of NIH and out of MIT.

24 And so, while I maybe can't give you specific 25 items, were the committee to have some comments and NEAL R. GROSS ocuar nemmue me vnumenesas 1333 RMODE ELAND AVENUE. N.W.

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suggantions about appropriateness of security in given j 2

situations and what some of those impacts might be, either 3

generated during this meeting or perhaps separately as 4

individual consultants, that input would be very useful.

)

5 We are on a tight time frame. I would expect that we will 6 need to be to the commission with our analysis and some 1 l

7 recommendations by the end of the year or very early in 8 next year. Typically, IITs are on-site for a week or two 9 and then have 45 days to complete the report and provide }

10 the report to the commission. That will place it prior to 11 the end of the year. And the commission will be expecting 12 that the analysis associated with the regulations and ,

13 guidance will be right behind it. So, we are in a very --

\

14 a relatively fast moving time frame.

15 CHAIRMAN SIEGEL: Given that time frame, 16 consider the possibility that one or more members of this 17 committee might be asked to, not necessarily join the IIT 18 team, but rather to come in at some point to hear what's 19 going on and at least lend a perspective that you might 20 not have within the agency.

21 DR. COOL: Certainly take that into --

22 CHAIRMAN SIEGEL: So, I'm sort of following 23 two--

24 DR. COOL: --

as a thought as how to best try 25 to accomplish that. That is an interesting idea.

~

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14 1 CHAIRMAN SIEGEL: Judy?

2 MEMBER BROWN: I just had a question. I'm not

(

3

. familiar with the MIT incident. Does that seem to be the l

{

4 i same deliberate internal action that the NIH was? ;

i 5 DR. COOL: We have nearly a matching set of 6 allegations.

7 MEMBER BROWN: Oh, lord.

I 8 DR. COOL: And at this point, it's obviously 9 way too early to tell what may or may not be truth. What 10 generally happens is that the first reports of the events i i

11 and everybody scrambling around, you usually figure that !

12 maybe 50 percent or more of what you just heard is wrong.

O 13 That's part of what the team which is currently on-site is sm, 14 going to try and figure out. But there are statements to 15 that effect and there is certainly some evidence which, if i 16 true, would lead you to believe that this was something 17 besides accidental. But, until the facts of the matter 18 are ascertain with a lot more clarity, that is an open 1 l

19 question.

20 Are there other questions I can answer?

21 If not, I wish you well in your deliberations. I 22 You have a very busy schedule. I will try to stop back by 23 depending upon how much other activities with some of the 24 incidents end up taking of my time.

()

/~~'

25 Thank you very much.

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15 1 MR. CAMPER: " hank you, Don.

2 All right. Let us continue with just a few 3

more administrative items before we open business.

4 I want to introduce the committee members that-5 are present today for the record. We have Dr. Woodbury at 6 my extreme left representing the FDA. Dr. Lou Wagner who 7 is a practicing physicist. And Mr. Dennis Swanson who is 8 a radiopharmacists. And Dr. Judith Stitt who is a 9 practicing oncologist radiation therapist. And Dr.

10 Josephine Piccone who is a section leader for the medical 4

)

lli and academic section. We have the esteemed chairman, Dr.

12 Barry Siegel. And to my right, we have Mr. Bob Quillin 13 representing the state regulator's perspective. And we f~)

\s_f 14 have Dr. Wil Nelp who is a practicing research specialist 15 and offers that perspective. We have Ms. Judith Brown who 16 brings us the patient's concerns and advocacy types of 17 concerns and issues. And we have Dr. Dan Berman who 18 represents cardiology interests.

19 In addition to the committee members, later 20 today we will be joined by several consultants who aid our 21 agency in evaluating misadministration events when we talk 22 about the use of medical consultants that Dr. Cool was 23 referring to. We will be joined later today by Dr. Peter 24 Almond, Dr. Mel Green, Dr. Petrovich, Evelyn Watson, and

/')

( 25 Dr. Richard Whittington.

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2 I'd also like to point out to the members of-3 the audience, and it very good, by the way, to see such a 4 good turn out from the public. It's very encouraging to 5 see your interest and I welcome all of you here. We do 6 have-a couple of requests to speak which Dr. Siegel will 7 address shortly. And also, we'd like to draw to the 8 attention of the audience the fact that there are several 9 members of the medical staff available. We have Sally 10 Merchant over here to my right, standing. We have Torre 11 Taylor over here to the left. And we have Dr. Holahan, 12 Trish Holahan. And of course, Josie, I've already 13 mentioned. We have -- there may be some others around. I

\

14 encourage you in the audience to chat with those 15 individuals if you have questions about the medical 16 program or processes. It may be easier to grab one of 17 them than it is to grab Josie or I. But, we're also 18 available if you have questions or thoughts and we 19 encourage.your questions.

20 Administratively, a couple of points. We do 21 have restrooms to the rear of the room. Go down toward 22 the television, turn left or right. Unfortunately, there 23 are no water fountains as Dr. Stitt has already pointed 24 out on this floor. But I think she might have found one

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17 1 cafotoric that has a very full selection of food and 2 drinks. So, please make yourself available to that if 3 you're so inclined.

4 So, with those introductions and 5 administrative comments, Dr. Siegel, would you please 6 chair the meeting for us?

7 CHAIRMAN SIEGEL: Thank you. Good morning, 8 everyone. Short and sweet. I won't presume to say that 9 the agenda for this meeting looks less onerous than the 10 one we had for the last meeting which I thought we'd zoom 11 through without much difficulty but it seemed to go on, 12 and on, and on, and on. But, I think the issues this time l

13 look like they're relatively more focused and we ought to 14 be able to get through each of them in the allotted time.

15 And we ought to get rolling so that since we're already 16 about-ten minutes behind schedu.la.

17 We have three requests for public comments.

18 Requests from the American Society of Nuclear Cardiology, 19 request from ASTRO, and a request from Tri-Med. And 20 rather than take the public comments as a block, I will 21 use the chairman's prerogative to align those public 22 comments with the corresponding discussion items so that 23 they fit better with what we're talking about. And 24 consequently, the Nuclear Cardiology one will go with this

( 25 first time this morning, the ASTRO one with the NEAL R. GROSS CXMtf REPORTERS AND TRANSCRWERS 1333 RMODE WLAND AVENUE. N W.

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intravascular brachytherapy issue, and the Tri-Med one 2

with the petition immediately following. And we'll 3

actually take the Nuclear Cardiology comments following 4 Sally Merchant's introductory comments so that the 5

representative from ASNC can hear her material and help us 6 focus the discussion.

7 I want to make clear, and Sally, I'm sure, 8

will make clear in a moment, that we are not opening up 9

for discussion the entire issue of training and experience 10 criteria for licensure as.an authorized user. That's not 11 a topic of discussion that this committee is going to 12 consider any time until after the National Academy of 13 Sciences report has hit the street, until we've evaluated

-- 14 it, .until -- and until the Part 35 rewrite gets going in 15 earnest.

16 So, with that minor introductory comment, we 17 will conduct our business today as usual. And we'll give 18 everybody a chance to participate in consensus building.

19 Are there any other introductory comments from 20 other members of the committee?

21 I'm told that ASTRO only gave us written 22 comments and that no one's actually going to make a 23 presentation. So we'll look at their written comments.

24 And with that, we'll let Sally take the floor b

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19 1 exemptions by this committee.

-s 2 MS. MERCHANT: As Dr. Siegel said, training 3

and experience was an agenda item at the last meeting. As 4 a result of that meeting, physicians who apply to be 5 authorized users on NRC licenses but who do not meet, 6 fully meet, the requirements of 10 CFR Part 35, Subpart J.

7 require an exemption in order for that to -- for them to 8 become authorized users. Exemptions requests will be 9 reviewed by the ACMUI.

10 The purpose of this presentation is to develop 11 some procedures for the advisory committee to use -- for 12 the staff and the advisory committee to use. I've 13 provided a strawman and I'm hoping that the committee will

[ )

\s_/ 14 help me to fill it out so that we can come up with a 15 really usable procedure.

16 Just for clarification, 10 CFR 35.920 (b) is 17 the other category for physicians who want to do 18 diagnostic procedures and want to be authorized users to 19 do the diagnostic procedures. And 35. 920 (b) requires 200 20 hours of classroom and laboratory training in basic 21 radioisotope handling techniques and 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of 22 supervised work experience under the supervision of an 23 authorized user, and 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of supervised clinical 24 experience under the supervision of an authorized user.

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20 1 those excmptions, And they say -- it says, in part, "Tho

,s 2 commission will review requests for exemptions from

(

'v) 3 training and experience requirements with the assistance 4 of the advisory committee on the medical uses of .

5 isotopes." l 6 Applications to become authorized users on NRC

{

I 7 medical use licenses are submitted to the appropriate NRC 8 regional office. We're actually going into the procedure 9 now. If, when reviewed, the submitted training and l 10 experience does not meet the criterion listed in 10 CFR 11 Part 35, Subpart J, an exemption would be required to j

. I 12 approve the request. The request for exemptions to 13 Subpart J are forwarded to NRC's headquarters in the form 14 of a technical assistance request which is a formal 15 request from the regions for us to provide some guidance 16 or -- does someone have a question? And we call those 17 TARS. And you'll see them referred herein as TARS.

18 CHAIRMAN SIEGEL: Sally, real quickly, I think 19 we've asked this question before I don't remember the 20 answer. You are getting on average how many of these !

l 21 annually?

22 MS. MERCHANT: We don't have a number because 23 as we discussed last time, there was some small overlap.

24 So, if there was a small concurrence allowed, it --

t 25 between the 500 and the 500. And it varied and the

%/ ,

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licansa reviewar would review usually based on what they

-2 had done rather than hours.

So all of them didn't come l O 3 into headquarters. l

{

4 Guidance is going out to the regions, and has I

5 gone out to the regions, to -- that all of them must come 6 in now. So, up until now, we've only got one that needs 7 to be reviewed by this committee. We expect it will be {

8 several. I really couldn't put a number on it.

9 What do you think, Larry?

10 MR. CAMPER: Well, I think the number that we 11 actually get at headquarters is small. I think that 12 probably 5 or 6 a year, perhaps one or.two which makes i s 13 it's way to this committee. But that's only part of the I 14 picture.

15 What we found when we queried the regions on 16 this topic, we found that, in all candor, the regions were 17 processing these types of applicants differently. Some of 18 them were expecting more hours to be demonstrated. You 19 might recall from Sally's first slide that there's 1,000 20 hours of experience with the types and quantities and 21 clinical experience along with 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of didactic. 200 22 hours of didactic is fairly simple and straight forward.

23 It gets a little more complicated when you look at the 500 l 24 and the 500.

25 So, I think the bottom line is, is that at NEAL R. GROSS COURT REPORTERS AND TMANSCRGERS 1333 RM00E ISLAND AVENUE, N W.

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22 1

number of those applications, many more than the number I 2

O mention, probably on the order of -- I don't know exactly k) ms 3 how many physician applicants apply to be authorized users

\

4 per year, particularly for the limited use in cardiology, )

i 5 but I suspect the number's on the order of 50 to 100, i

6 something in that ball park, I suspect, maybe a couple of 7 hundred. But the numbers of hours that they have 8

presented and the way in which they have been processed by 9 the regions has varied and is different. And one of the 10 things we're attempting to do, and there are several 11 things, but is to try to lend uniformity and consistently 12 to that.

,_ 13 You might recall that during the last meeting

, , , ) 14 we discussed some of the problems that we were seeing and 15 tried to developed a model for dealing with it more i

16 generically,,1f you will, although we weren't really 17 talking about generic exemptions. We were talking about a 18 model to use to process all exemptions, be it on a case-19 by-case basis.

20 So, I think the truth is as Sally says, we 21 don't really know the exact answer but certainly there has 22 been variability with regards to how they've been 23 processed. And that's been part of the problem. We don't 24 know just how many there are.

25 MS. MERCHANT: All right.

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23 1

To cpply for an exemption from Subpart J, the 2

TAR must provide all supporting documentation including

(- 3 documentation of the applicant's classroom and laboratory 4 training and documentation of the supervised work and 5 supervised clinical hours the applicant has submitted.

6 The NRC's headquarters staff member who is 7 assigned the TAR will prepare a package for the ACMUI with 8 a cover memo indicating the procedures of the review. The 9 package will be provided to the NRC headquarters ACMUI 10 coordinator who forwards it to the appropriate ACMUI 11 members.

12 The procedure for the ACMUI review is as p,

13 follows. The prepared package will be provided to the k, 14 appropriate members with a cover memo indicating the time 15 frame, typically two weeks, for review and procedures for 16 returning responses. In order to comply with FACA meeting 17 constraints, ACMUI members can't discuss the exemption 18 request with each other and should submit their reviews to 19 NRC in writing.

20 MR. CAMPER: Is it clear to all the committee 21 members what Sally means by FACA meeting?

22 MEMBER NELP: No. No, it isn't.

23 MR. CAMPER: Sally, could you clarify that a 24 little bit for them?

s

} 25 MS. MERCHANT: According to Part 7 of Code of NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1333 RHODE ISLAND AVENUE. N W.

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24 1 -- of Title 10 of the Code of Federal Regulations, two or l

s 2 more members are a meeting. Meetings have to be noticed. 1 i

3 Therefore, you can't really -- according to Part 7, you 4 can't discuss this with each~other. According to Part 7.

5 Are there any other questions?

6 MEMBER NELP: What's FACA?

7 MS. MERCHANT: That's FACA. Have we 8 misinterpreted, Dr. Woodbury?

9 MEMBER WOODBURY: No, not that I'm aware of.

10 MS. MERCHANT: Thank you.

11 MR. CAMPER: Just point out, Sally will point 12 out in a minute, Dr. Nelp. If it turns out that

- 13 deliberation is needed, there is a mechanism for doing 14 that.

15 MS. MERCHANT: We have that.

16 MR. CAMPER: She's not through that. But the 17 problem is, if we disseminate the packages to committee 18 members individually for your distinct and individual 19 reviews, because of the sunshine provision associated with 20 FACA, if you're going to deliberate with a colleague on 21 the committee, we get into a noticed scenario. It's just 22 public disclosure is the --

23 MEM3ER NELP: May I be so bold as to ask what 24 FACA means?

( 25 CHAIRMAN SIEGEL: Federal Advisory Committee NEAL R. GROSS COURT REPORVdRS AND TRANSCRWEM 1333 RMODE IM.AND AVENUE. N.W.

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25 1 Act.

g-~ 2 MEMBER NELP: Thank you.

3 MS. MERCHANT: After the committee member has 4 reviewed the package, the findings should be returned to 5 NRC in the provided self-addressed envelope. I would ask 6 that after you review the package, you either return the 7 package to us or destroy it. Keep in mind that you, as 8 well as your colleagues, would not like your private 9 business publicized. So it's really better to -- these 10 must be kept private.

11 Once all comments are received from the ACMUI 12 members, the responsible NRC staff member reviews the 13 comments and determines a majority opinion. The staff, in

\ ,

14 consultation with the Office cf the General Counsel's 15 staff, makes the determination as to whether the exemption 16 will be granted. The staff member maintains clear 17 documentation of the ACMUI review and the basis for the 18 final decision.

19 For applications for unusual or atypical use, ,

1 1

20 the following procedure for a conference call may be 21 followed. A time will be arranged by NRC with agreement 22 from all participants for a conference call. And this 23 would require a Federal Reaister notice. Minutes of the 24 meeting will be prepared by the NRC staff and signed by 25 the ACMUI chairperson or designee. The meeting should be NEAL R. GROSS munt nemnuns ANoinaNecamens 1333 RMODE 80 LAND AVENUE, N W.

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26 1 ocheduled within two weeks of receipt of the TAR.

, 2 CHAIRMAN SIEGEL: Sally, are you constrained 3 by a 30 day Federal Recister notice requirement, or can 4 you shorten that?

5 MS. MERCHANT: I think that there is a 6 provision for what I think is termed, and don't hold me to 7 this, unusual circumstances such that Federal Recister 8 notices can go in with no time constraints.

9 CHAIRMAN SIEGEL: Torre, d.'.d you want to 10 comment about that?

11 MS. TAYLOR: Yes, also it would be a closed 12 session so we would definitely --

13 CHAIRMAN SIEGEL: In a way it's slightly O

14 oxymoronic that you have a Federal Recister notice to 15 announce that you're having a closed session of an 16 advisory committee. But I understand.

17 MS. MERCHANT: And then finally, the NRC staff 18 member who was assigned the TAR provides a written 19 response to the region. ACMUI members who participated in 20 the review will be on distribution for the TAR so that you j 21 will be able to follow the outcome of what happened.

22 I have a series of questions. Could you 23 excuse me for just a second. I don't know where they are.

24 CHAIRMAN SIEGEL: Do we want to take the 25 gruestions now or do we want to wait and hear comments from NEAL R. GROSS coUar anarnas me nwecamens taas aH00E WUW40 AVENUE. N W.

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27 1 the ASNC?

2 MR. CAMPER: Well, what I would like to do is 3 at least, if we --

4 CHAIRMAN SIEGEL: Pose the questions.

5 MR. CAMPER: Yes. I'd at least to pose the 6 questions so the presenter is aware of the questions. And 7

then we can then discuss them -- let them make their 8 presentation and then we can discuss the questions.

9 CHAIRMAN SIEGEL: Dan?

10 MEMBER BERMAN: Can we ask questions just to 11 clarify what she presented?

12 CHAIRMAN SIEGEL: Of course.

13 MR. CAMPER: Sally, Dr. Berman --

t C 14 MEMBER BERMAN: Sally, I just want to clarify j 15 something that you had said which is on, I think, on your ;

16 second overhead that had 10 CFR 35.920 (b) . Is this -- If 17 somebody applies with all of these, 500, 500, and 200, 18 does that have to come through this exemption?

19 MS. MERCHANT: No, you've met the requirement.

20 MEMBER BERMAN: Good. I needed that 21 clarification. Because related to that, I think, then, we I 22 have to have some basis for determining, well, if they i

1 23 don't meet this, then what's enough.

24 MS. MERCHANT: Well, the first question is, 25 which members will perform the reviews? Is this -- This NEAL R. GROSS count meamas ANo rwecaeEas 1323 RHODE ISLAND AVENUE, N.W.

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28 1 10 your decision.

Do we need the entire committee?

s 2

( Should it be a subcommittee of some number of members?

'- 3 Should there be any qualifying criteria? Is it something 4

-- I'm kind of going through the questions because they 5 all kind of group together. Do you want to have rotating 6

committees where four will do it from this date to this 7 date, four more will do it from this date to this date.

8 This is entirely up to you. What do you think? Who ,

l 9 should review these?

10 MR. CAMPER: Let me point out. As you ponder 11 that question, and again, after the presentation we'll go 12 through the questions in more detail. But as you ponder 13 that question, you probably should bear in mind that I

\m / 14 would expect to see more of the exemption requests being 15 processed by this committee than has historically been the 16 case. Because, as I said earlier, our findings have been 17 that the regions have processed these applicants 18 differently. And this really all gets back to this whole 19 concept of the fact that the 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of the types and

\

20 quantities and the 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of clinical experience can be 21 obtained concurrently. And that's bene sort of a working 22 concept for years, probably with not the degree of 23 clarification and guidance from headquarters that I would

)

24 have preferred as I go back and look at it.

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29 1

matter, epplicants and professional organizations, havs 2

C interpreted the concurrent concept differently. Some k )\ ,

3 believe that 500 and 500 translate into one 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months . I 4 mean, that's concurrent at a one-for-one ratio. I think 5

most of us in the program have viewed concurrent training 6 a little bit differently than that. But then you start ,

7 getting into a situation when you begin to articulate just 8 what you mean by that and you start involving the office 9 of General Counsel and you start to get a literal 10 interpretation of the regulations which is what we were l

11 discussing with you last time.

t 12 So, given that we have instructed the regions )

13 to look at these closely, to process them in a fashion ,

k ,) 14 that we're going to come to closure on today, we'll see 15 more of these. So, you might bear in mind how you want to i 16 structure your deliberations given that we might see --

17 again, I don't know exactly what the numbers -- but we 18 might see 25, 30, or 40 of these a year.

19 MS. MERCHANT: I would also add that this does 20 not mean you can't revise the procedure at the next 21 meeting if we find that it --

that whatever the procedure 22 that we all agree on doesn't work for one reason or 23 another, it wouldn't be a major thing to revise a 24 procedure.

t 25 CHAIRMAN SIEGEL: You don't need to see 35 or

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30 1 30 of theca a year. What you need to do is to revise the 2

. training and experience criteria to make them rational.

3 And that's the problem. And I recognize that that's not 4 an item that's open for debate.

5 MR. CAMPER: I think you said that, didn't 6 you?

7 CHAIRMAN SIEGEL: And I said it. Well, we're 8 not going to debate the specifics. We're going to get the 9

principle on the table which I've done over, and over, and 10 over again. And I have a couple more -- two more 11 meetings, at least, to do so.

12 MEMBER NELP: I'm concerned t hat you really 13 can't give us the volume of the work. I mean, if it's one r

14 a year, it's not very much. If it's 200 a year that are 15 being processed out in the field, that might be 16 worthwhile. But you're devoting a lot of time and effort 17 to --I realize there is a problem but I would sort of like 18 to know what the magnitude of the work effort is for the 19 NRC. Because if it's really as small as it might be --

20 MS. MERCHANT: Let me say just for your 21 information, and I don't believe that this is telling 22 anything that is proprietary. I've been doing a study of 23 training and experience involved in it, been looking at 24 the 200 hour0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months courses, and I can say with some confidence 25 that they graduate probably about 1,000 a year 200 hour0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months .

[u )\ .

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31 1 I would suspset that some portion of them will apply for 2 exemption. They do greater than 1,000 a year.

3 MEMBER NELP: These are proprietary evening, 4 weekend type courses?

5 MS. MERCHANT: Yes. So that's -- I can tell 6 you that's what the volume is as far as those people that 7 are taking the 200 hour0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months course. I mean, that's just off 8 the top of my head rather than give you -- they gave me 9 numbers. Everyone was very cooperative.

10 MEMBER NELP: Are the instructors in these 11 programs highly credentialed by your criteria?

12 MS. MERCHANT: I wouldn't want to get into i 13 that before we release the report.

3 (d 14 MR. CAMPER: Let me make a comment there for 15 your benefit, Dr. Nelp, and that of the committee. )

l 16 Sally's referring to a study that we have 17 done, private sector programs providing a 200 hour0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months 18 didactic component. That's phase 1 of a three phase plan.

L i 19 Phase 2 will be to go look at some of the residency j 20 programs that are going on because there have been some l l 21 fairly significant comments which have been made about the 22 quality and the number of hours being provided in a 23 residency program. So, whether they line up with out 24 regulations and whether we think -- what is actually going O\

V 25 on is what we think is going on, et cetera, et cetera. So l NEAL R. GROSS COURT MPORTERS AND T1WeSCRieEM 1333 MHDOF ISLAND AVENUE, N.W.

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32 1 at soms point in phase 2, we're going to put in place a

. 2 contract to go look at residency programs. That will 3 probably begin to occur early in calendar '96.

4 Phase 3 will be to compile all these findings 5

and at some point during the process of the major revision 6 to Part 35 which will commence following the National 7

Academy of Science report, we intend to have amongst a 8 series of public meetings a public meeting that would 9 involve the various professional societies that have a 10 vested interest in this. The American College of Nuclear 11 Physicians, the Society of Nuclear Medicine, the American 12 College of Radiology, the group representing the 13 cardiologists, and so forth and so on, endocrinologists, 14 and there may be others that I haven't thought of.

15 And at some point, we'll sit down with all of 16 those bodies and we'll say, look, this is the current 17 training and experience criteria in our regulations. We 18 went and look at how that training is occurring. Now, 19 this is what the training is. This is what we found. Why 20 don't you talk to us about, (a), Dr. Siegel's point which 21 he brought up a few minutes ago and that is, what about 22 the appropriateness and adequacy of the existing training.

23 If this is not right, what should it be? And secondly, 24 the mechanisms by which it's being provided, the actual 25 number of hours of training that occurring. What's right NEAL R. GROSS COURT REPORTERS AND TRANSCRMERS 1323 RHODE WLAND AVENUE. N.W.

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l 33 1 with it. What's wrong with it. And how do we fit it. l 2 Or, for that matter, is the concept of achieving a number l s 3 of hours the entirely wrong concept. Is there a better 4 alternative? If so, what is it? So forth and so on.

5 Because all those professional societies representing the 6 various types of physicians practicing that want to use 7 byproduct materials in the course of practicing medicine, 8 we think they're the ones who should help us figure out 9 what it should be. Because obviously right now it's very l

10 controversial.

11 So, the study to which she's referring is just 12 phase 1 of a three phase program.

13 CHAIRMAN SIEGEL: David.

(A \

s ,/ 14 MEMBER WOODBURY: Well, Larry, the thing that 15 seems to me to be is getting some feel for what numbers 16 we're talking about. It makes a difference if we're 17 talking about 1,000 per year, 100 per year, or 10 per year 18 in terms of answering the questions you've asked us. I 19 think that's the question Bill and I want to get some 20 feeling for.

21 MR. CAMPER: Again, I wish I could give you a 22 number. I really do. If I could, I would. But with 23 regards to the 1,000 number, Sally's number is a very 24 accurate number in terms of number of physicians that are (r) 25 completing the 200 hour0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months program on an annual basis.

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34 1 obviously all 1,000 of them don't process their 2 applications in the same year. They take -- some of the,

(

\ 3 for whatever reason, don't go on to complete the 500 hour0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months , 4 500 your components. Some of them do it over a somewhat 5 protracted period of time, several years in fact.

6 Again, I don't know the exact numbers but I 7 think it's reasonable to assume that in the regions we're 1

8 seeing 200 or 300 of these a year. And of those, if I 9 take a look at how the regions have processed them j 10 differently, and I look at this current focus and k 11 clarification of what concurrent means or doesn't mean 12 depending upon how one looks at it, I would expect that 73 13 you'll probably see, again, I think a good working number .

14 is 30 or 40 of these a year.

15 MS. MERCHANT: Yes.

16 MR. CAMPER: Maybe a few more but I just can't 17 be more explicit. I wish I could.

18 MEMBER BERMAN: Based on what you said and 19 based on the growth of the field in cardiologists, and the 20 growth of the number of people interested, and the 1,000 21 people per year supporcs this. I think it's an under 22 estimation to think it's going to be small. It would, of 23 course, depend on whether or not the track record is that 24 there are any exemptions that get through. Be it if they

()

/"

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35 1 everybody will coma up with 1,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months . And so, our 2

f) discussion about what -- is there any flexibility in that

(_,/ 3 1,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months is going to be relevant to this. But if there 4

is some flexibility, I think it's going to be more in the 5

range of a couple hundred or a few hundred per year rather 6 than 30.

7 MR. CAMPER: That's a good point. I was going 8

to mention that a corollary, a fall out of this, you're 9 right, is that as the word gets out that there's more 10 scrutiny being applied, some of those that would have 11 applied for exemptions will not. some will simply say, 12 okay, I've got to get 1,000 and that's it and be done with 13 it. Others may test the waters for a while. And you're

,/

14 right. We don't know how that will play out. But the I

15 numbers could be that high. I acknowledge that. I 16 CHAIRMAN SIEGEL: What we've most often done 17 in the past, this committee, is that we've been asked to 18 look at training that essentially met the required hours 19 but was acquired in unusual training circumstances, such i 20 as in a practice environment as opposed to in a formal 21 institutional training environment. And so, we've been 22 asked to judge whether the quality of the training i

23 experience based on the documentation provided to us in 24 that unusual educational environment was appropriate for

^

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36 1

hao 600 hours0.00694 days 0.167 hours 9.920635e-4 weeks 2.283e-4 months but ha says hm's a good guy and his 2

preceptor says he's a good guy. Should we approve it.

3 And frankly, I think that that would be an exceedingly 4 unfair and dangerous thing for us to do. And the right 5

way to attack that one, Dan, is not to allow exemptions 6

while these rules are in place, but to deal with these 7

rules in a logical orderly fashion as quickly as possible.

8 MEMBER BERMAN: I think, though, that if you 9

do focus the discussion only to what you said, that you 10 will have, I believe, excessively narrowed the scope of 11 what could be done through this committee. It was --

12 That's why I clarified in my question what did 10 CFR 13 3 5. 92 0 (b) say. It says, 1,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months .

What are being

,_ 14 asked to look at? We're being asked to advise on 15 exemptions. People who do not meet exactly what is there.

16 Now, your interpretation of what our scope 17 might be was just now focused on whether it was done in a 18 full-time training program or in a not full-time training 19 program. Based on Mr. Camper's earlier discussions here, 20 which was that in the past there has been -- and Sally 21 Merchant mentioned that there has been a small amount of 22 concurrence allowed, and Larry just referred to the fact 23 that there has been some concurrence allowed, it's part 24 of, I believe, necessary for this group to discuss the f3

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37 1

allowed in order to determine whether or not an exemption (h

2 is discussable.

i 4 (ms/ 3 CHAIRMAN SIEGEL: We've all -- the issue of 4 concurrence is addressed in the regulations because it 5 says all of the above can be accomplished in a six month 6 training period. And we-know that 1,200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months is more 7 than six months. That's the level of concurrence that's 8 built into the regulations themselves. I think it would 9 be exceedingly dangerous for this committee to deviate 10 from that concurrence posture without the whole issue 11 being really analyzed in great detail. And first of all, 12 we don't have the time to do it today. We're already ten 13 minutes over schedule and we haven't heard from the ASNC

( ,/ 14 yet, and haven't answered the questions. And we -- to do 15 it before the National Academy of Science's report would 16 just be not right.

17 MR. CAMPER: A couple of points. Let me just 18 interject here, Sally.

19 Barry, I understand what you're saying and I 20 know why you say that. But let me bring a couple of 21 things to bear that the committee must keep in mind.

22 The problem that we -- where we are today is 23 today is that the concurrent issue has been dealt with 24 informally historically. What has happened though is that O} 25 as a result of increasing interest the staff has been NEAL R. GROSS COURT MPORTEM AND TRANSCf4EM 1323 MH00E RANO AVENUE. N.W.

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38 1 forced to doel with this issue in a logical approach and 2 understand exactly what needs to be done to process these.

\'- ' 3 When that happens, you then get into an interpretation of 4 your existing regulations. The more there is pressure 5 applied, and the applying of pressure is okay, we don't 6 mind that. That's part of the regulatory process. But 7 what happens when that occurs is that you then are forced 8 to deal with things literally and to put in place a 9 procedure accordingly.

10 Now, our dilemma then, having said 11 that, is as follows. You have a couple things. 35.19 12 talks about specific exemptions. The gist of 35.19 is

,- 13 that exemptions will be entertained by the commission. It

s. 14 goes on to conclude by saying that the Commission will 15 review requests for exemptions from training and 16 experience requirements with the assistance of its 17 Advisory Committee on the Medical Uses of Isotopes.

18 Now, what that means for you, 19 unfortunately, ladies and gentlemen, is that it's not just 20 about whether or not it's been obtained in a formal 21 program or an informal program or a private hospital or 22 whether it seems to pass the smell test. It's more than 23 that. It's evaluating and assisting the staff in any 24 exemption request and that could be as simple as 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months 25 versus 1,000 hours0 days 0 hours 0 weeks 0 months .

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39 1 Now, you also cannot come to a 2 conclusion ahead of time that you will not entertain

/f-s) k/s 3 anything but 1,000 hours0 days 0 hours 0 weeks 0 months because you must evaluate each 4 exemption on a case by case basis. Now, Barry's point, 5 Dr. Siegel's point about really entertaining less than 6 1,000 hours0 days 0 hours 0 weeks 0 months at a time when we know the real issue is to 7 look at the training experience requirements is obviously 8 a very logical approach and it makes sense. But the 9 problem is, unfortunately, you can't give yourself the 10 luxury of doing that approach because you simply must help 11 us entertain any exemption and we must look at them on a 12 case by case basis.

13 You may in the final analysis O

m, / 14 conclude through your Committee deliberations that you're 15 not prepared to let Dr. X submit less than 1,000 hours0 days 0 hours 0 weeks 0 months and 16 your rationale is, or Dr. Y or Dr. B or Dr. Z. But again, 17 you must entertain it on a case by case basis.

18 CHAIRMAN SIEGEL: And my major 19 concern is that it would be inappropriate for this ;

20 Committee to exercise its perhaps whimsical judgments day 21 by day on a case by case basis when there are fundamental 22 principals that need to be established first and that 23 we're not going to be able to establish until the whole 24 set of arguments are on the table.

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40 1 what you just said, Larry, is for every cardiologist who 2

j wants to do this, but simultaneously every radiologist, 3

every person with any other kind of training, and every 4 radiation oncologist who wants to be able to become 5 certified to do this with only one year of residency 6 instead of four years of residency to instantly put in a 7 request so that the ACMUI can spend its full time doing 8 nothing but evaluating those requests.

9 I'm making a reductio ad absurdum 10 here intentionally to point out the fact that it's wrong 11 for this Committee to deviate very much, 1f at all, from ,

12 the rules that are currently in place until the basis for p 13 these rules have been reevaluated thoroughly, carefully 14 and rationally. I acknowledge that you've got procedures 15 here and we'll take those exemptions as you get them and 16 we'll duke them out. Depending on who's in the room on a 17 given day, you may or may not get outcome A versus outcome 18 B. That really to me seems a terrible mistake.

19 MR. CAMPER: Well, I understand 20 again why you say that way, but that's exactly what we'll 21 have to do because there is a mechanism for exemptions in 22 the regulations. It's explicit the.t if it deals with 23 training and experience we'11 use the Advisory Committee 24 to aid us. We do that because as physicians and as

("

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41 1 concept in that you're in the best position to aid a 2 regulatory staff. None of us are physicians, but many of 3 us are physicists and so forth. But you're in the best 4 position as practitioners to aid us in determining whether 5 or not the training and experience presented is adequate 6 or if it should be grounds for an exemption.

7 Unfortunately, the simple truth of the matter is whatever 8 we end up doing, whatever it might be with regards to 9 adjustments in the training and experience criteria, and 10 no one knows at this point, but whatever it is it will 11 take a substantial amount of time for that process to play 12 out given the public due process that's associated with 13 rulemaking, et cetera, particularly one of the magnitude v 14 of the planned revision of Part 35.

15 What that means is that probably 16 over the next three or four years, I suspect, there will 17 be many exemption requests that this Committee will need 18 to review under the current criteria. I understand and I 19 know why you feel the way you do, but that will be the 20 challenge before the Committee. Unfortunately, we have to l 21 deal with the rules we have now until such time as they're 22 changed. I 23 MEMBER BERMAN: Barry, I think that 24 given the fact.that what Mr. Camper has told us is that 25 these exemptions will be entertained, that there will be, NEAL R. GROSS coum nuorens ANo rn4Necamens l 1333 nMOOE 1SLAND AVENUE, N.W.

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42 1

I balievo, many applications that are going to come before

- 2 the Committee. Now, one possibility would be that we're

'L/) 3 going to just adhere to our time schedule. We're not 4 going to even discuss what are going to be the various 5 people who might sit on these committees attitudes towards 6 this concept of concurrence or we could have at least a 7 discussion at this point so that we can understand what 8

kinds of issues should be dealt with as we're going to be i 9 dealing with these exemptions. )

I think that it's wrong to 10 eliminate discussion at this point in this morning's 11 meeting because of the fact that we are going to have to 12 go ahead and evaluate these exemptions requests.

. 13 I am a cardiologist and a nuclear

(

s_ 14 medicine doctor. I sit on this Committee because of my 15 representation of both sides and I need at least a few 16 minutes to be able to discuss a view about what is behind 17 this issue of concurrence. I guess there's a request from 18 ASNC to present.

19 So, it seems to me that there are 20 several minutes of discussion that need to take place this 21 morning for us-to have a good concept of what to do over 22 the next year in terms of these exemptions. l 1

23 MR. CAMPER: I would suggest that --

24 again, I certainly understand your concerns and Barry as (O)

%d 25 the chair can orchestrate this. But again, I think the ,

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43 1 point that Barry made in the beginning is the one to focus

.s 2 upon. To the extent that you can focus your discussions

)

(__/ 3 upon the process for the handling of exemptions requests 4 and the process of this committee reviewing those 5 exemption requests as opposed to the question of whether 6

the training and experience is right, the level currently 7 in our regulations is appropriate or not, you need to 8 focus upon processing of because you'll never resolve the 9 other issue at this point and there will be an opportunity 10 to do that.

11 MS. MERCHANT: May I suggest that if 12 there is some discomfort with the procedure of 13 independently r.eviewing and not concurring, we could s,, 14 probably set up conference calls with those members that 15 you all decide would be appropriate and resolve several'at 16 one time. That's another way to approach it. The B 17 method for unusual or atypical applications. If it would 18 make everyone have a higher comfort level, it could be 19 arranged. It would not be something that we couldn't do. '

20 CRAIRMAN SIEGEL: I think we should 21 deal with the procedural issues and we're going to because 22 those are the questions you've asked us. I think we 23 really can't deal with the specific exemption issues.

24 I've said that 19 times and I'm saying it again. In part,

( ) 25 I think having this Committee look, as directed by the Q/

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44 1

regulations, on a case by case basis will help focus this

, 2 Committee's thinking when it comes time to advise the NRC

(

\ 3 on the overall redo of the process.

4 MEMBER BERMAN: But the problem that 5 I see is this, Barry. You as the Chairman have said that 6 it's your view that the degree of concurrence that it 7 would be acceptable would be to go from 6.92 and from 1200 8 hours down to 6 months, which is a reduction of some 9 amount of time. Your opinion is that --

if I interpret 10 what you said earlier, the way you read it, we should be 11 looking for that 1,000 hours0 days 0 hours 0 weeks 0 months and the 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months , look for 12 the 1200. If they' re not there, then we don't even I

13 consider it. I believe that we need to understand are you

(

\~ / 14 correct in giving that as your opinion? Is that the way l 15 it is or, in fact, is there some' flexibility that you have 16 not expressed? If you're prepared to say that you say 17 it's 1,000 hours0 days 0 hours 0 weeks 0 months and that's as low as it goes, then that l

18 would be the end of the discussion. If not, we need to i 19 discuss this.

20 MS. MERCHANT: Let me put something i

21 else in here rather quickly. You all once reviewed a i

22 physician's training and experience who did not meet the l 23 1200, decided that the experience that he had had was 24 excellent and you suggested what else he needed to do in n

( 25 order to meet. It was not -- he actually had not gone NEAL R. GROSS CX)URT REPORTERS AND TRANSCRetERS 1323 RHOOE ISLAND AVENUE, N.W.

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45 1 through a formal procedure. What you suggested was very i 2 doable for him. So, in some of those cases, although you 3

may not accept what's submitted, after reading what the i 4

physician has done, we would hope you'd make suggestions 5

that this physician would meet if he did whatever you 6 found appropriate.

7 CHAIRMAN SIEGEL: Dan, I completely 8

understand what you're caying and I'm just telling you 9 that I think that for us to open this up in the mechanism l 10 you suggest will create a free for all. I don't think 11 that that's the way federal licensure should occur. For j 12 us to simply sit-down and look at Part 35 and say, "You 13 know, what we really think is that you can really do all O 14 of this in three months," and let's come right out and say 15 that, a lot of work went into the creation of these 16 regulations. Obviously . lot of political pressure in 17 multiple directions went into the creation of these 18 regulations. For this advisory committee to sit here in 19 ten minutes, we're way over time now, and think that we're 20 going to open this up when this is going to need to be a 21 multi-day discussion after much evidence is on the table 22 doesn't make sense.

23 I'm willing to do whatever the 24 Committee believes and we'll juggle the agenda if that's

() 25 what we need to do.

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46 1 MEMBER NELP: I'd like to make a 2

It seems to me that you're dealing with a comment.

Y 3 problem out in the field and you want us to help you with 4 it. If you have people out there that you're granting l 5 exemptions to and you don't think that they're qualified 6 or it's questionable or you don't know how -- bring us to 7 date. I haven't seen one such situation. So, we're 8 talking about a rather nebulous area as far as our own l

9 personal interaction with these individuals.

10 I would be happy to review them in 11 light of the guidelines. Enough said. But go ahead and 12 do it. If your people in the field are feeling pressured, 13 then fine, I'd be happy to look at it. But I agree with 14 Barry, the regulations are in place. If I want to be 15 qualified or certified to do something in the medical 16 sphere that doesn't have anything to do with 17 radioactivity, if I want to be a certified oncologist or a 18 certified endocrinologist or a certified cardiologist, I 19 have to get the training and follow the rules. There's no 20 -- there's some flexibility, but not a whole lot.

21 MS. MERCHANT: Yes. I do not 22 believe --

23 MEMBER NELP: So that's how we look 24 at it. That's my advice.

25 MS. MERCHANT: I don't believe that NEAL R. GROSS COURT REPORTERS AND TRANSCmeERS 1323 RM00E ISLAND AVENUE, N W.

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47 1 wa have granted authorization for anyone who is 2 unqualified. I believe that the license reviewers --

\

3 MEMBER NELP: That's fine. I'm not j 4 perceiving the problem to be -- I don't understand exactly 5 where the problem is. If you have a problem with your 6 people in the field, we'll be happy to assist them in 7 evaluating credentials.

8 MS. MERCHANT: Larry would like to 9 answer this.

10 MR. CAMPER: Let me make something 11 clear. We don't have a problem with people in the field, 12 Dr.-Nelp.

s 13 MEMBER NELP: Okay.

- 14 MR. CAMPER: We don't have a problem 15 with authorizing unqualified users. Let me try to 16 articulate what the problem is.

17 MEMBER NELP: I would like to know 18 what the problem is.

19 MR. CAMPER: All right. Let me tell 20 you what the problem is. Our regulations, if you read 21 them, are very explicit. Two hundred hours, 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months and 22 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months . That totals 1200 hours0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months .

23 MEMBER NELP: It also, I believe, 24 says this can be condensed to the equivalent of six

( 25 months.

(

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4 48 1

MR. CAMPER: No, actually it does 2 not say that.

/)

k_/

s 3 MEMBER NELP: Oh, I'm sorry.

4 MR. CAMPER: It says something a 5 little different than that. There is the board 6 certification pathway. There is a pathway which we refer 7 to as the "or" pathway, which is the one I just described 8 which is 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months , 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months and 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months , and then it 9 has something else which literally is not correct also.

10 It says, "has successfully completed a six month training 11 program in nuclear medicine that has been approved by the 12 Accreditation Council for Graduate Medical Education and 13 that included classroom and laboratory training, work 14 experience and supervised clinical experience in all the 15 topics identified in Paragraph B of this section." That 16 doesn't exist.

17 What happens is that that group 18 approves programs, some of which contain within them a six 19 month program. But we're not aware of any literally six 20 month programs as described in that language that are 21 approved by the council. Okay? So, the language is off 22 base also.

23 MEMBER NELP: I'm sorry. I thought 24 that meant if they came and trained with Dr. Berman for

() 25 six months in his approved program and they focused on, in NEAL R. GROSS COURT REPORTERS AND TRANSCReERS 1333 RHODE WLAND AVENUE. N.W.

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49 1 this caso ocy, nuclear cardiology, that that was the 2 intention of that statement. I believe that's what

( 3 happens frequently.

l 4 MR. CAMPER: Let me try to ;

5 articulate for you what the problem is. It's not a j 6 question of our people in the field being able to review 7 . these. The problem is this. For years there has been a 8 working concept and my predecessor, for example, Dr.

9 Glenn, is on record as saying that training can be 10 obtained concurrently. But that's all that was said.

11 Now, some people interpret that to I 12 mean concurrentlp with regards to the types and quantities 13 experience and the clinical experience as being one for

(/ 14 one. Therefore, 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months resulting in a total of 700 15 hours, whether they do it in three months or six months or 16 two years, 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months .

j 17 Now, the problem is as attention has 18 continued to be focused upon this and as it became aware i

19 to us that there was interpretations of concurrent ;

20 differently than we perceived it and we ourselves have j 21 never set down and said, "Okay, exactly what do we mean by 22 concurrent?" We know that some of these things from 23 receipt of package to administration to the patient are l 24 done on a continuum. There's a concurrent effort going on O 25 there. ;

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50 1

So, as we attempted to articulate in 2

, guidance space for use by our regional reviewers just what

(

\ 3 we meant by concurrent, we developed and brought to this 4 Committee a model. The Committee resoundingly said, "We 5

do not want to entertain a model that could be used as a 6 guideline by your regional reviewers for the granting of 7 exemptions because we think that that, in essence, is a de d 8 facto way of creating a different set of regulatory {

9 criteria." Rather, we want to see each one on a case by i

10 case basis and we'll aid the staff in achieving the {

11 exemption possibility and pathway allowed in the 35.19.

12 Where we are today is to say, "Okay,

, e 13 we heard the Committee. We, in this case, chose not to go

'l l

l(_ 14 against the Committee's advice but rather to embrace the j 15 Committee's advice. We're now discussing with you a 16 mechanism to achieve that."

17 MEMBER NELP: And we said if you l

l 18 have a problem with those applicants, we would be happy to l

l 19 review them and assist you in evaluating their training, i

20 experience and credentials. That's a pretty simple 21 solution. I bet you it wouldn't take me or Barry or 22 anyone around this table very long to assist in a single i 23 evaluation.

24 CHAIRMAN SIEGEL: Judy? ;

(-~ l

!, j 25 MEMBER BROWN: After the NAS report v .

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51 1 is received and the revisions are done, will you also be

~s 2 granting exceptions under those new revisions?

t

\~-) 3 CHAIRMAN SIEGEL: Almost certainly.

4 MEMBER BROWN: So you'll still be 5 making it up as you go along.

6 CHAIRMAN SIEGEL: That's one way to 7 characterize it.

8 MR. CAMPER: Well, Judy, we would 9 hope in the best of worlds we would come up with a set of 10 criteria, although you'll never get total agreement. You 11 hope that you'll ultimately develop a set of criteria that 12 is reasonable, that is fair, that is obtainable and that p-~ 13 the community helps us come to closure on. But despite x- 14 that, there will always be a possibility for exemptions.

15 There has to be an exemption possibility in the 16 regulations.

17 Now, when you develop regulations, 18 what you're trying to do is develop the type of 19 regulations that won't require a lot of exemptions, the 20 granting of. But there will always be some.

21 CHAIRMAN SIEGEL: The notion that 22 the concurrence equals six months, there is some 23 historical precedent for that in terms of the fact that 24 the assurances provided to the NRC by the American Board 25 of Radiology such that it achieves deemed status under the v

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52 i

i regulations is based on the ABR's assurance that its

)

-s 2 candidates will have received six months of training and 1

~/ 3 the ACGME acts accordingly. Now, whether six months is i

4 the right number, four months is the right number as many 5 argued ten years ago, or whether three months or a week 6

with the right kind of preceptor statement is the right t 7 number I think can't be open for debate right now, but I 8

think must be debated carefully, thoroughly and changed in 9 the future.

10 Dan, I know we're disagreeing on i

11 this issue, but you actually realize that I agree with the 12 posture that the construct that is' currently here doesn't

,,,, 13 make sense and that the NRC's role needs to be focused on

(

\ 14 the radiation safety aspects of this and the training 15 requirements need to be much less to be an authorized user 16 under an NRC license and be divorced completely from the 17 clinical training requirement. I believe that, but I'm 18 not willing to change it in ten minutes at this table.

I 19 Now, having said that, we're way 20 over schedule. We have a request from Dr. Cerqueira to i 21 make a statement on behalf of the American College of 22 Cardiology and the American Society of Nuclear Cardiology.

23 Five minutes is allotted. He can make the presentation.

24 But Manny, I would ask you please to N

) 25 limit your comments to the procedural issues that are NEAL R. GROSS covar nemma ANo ruecamens 1323 nHODE tsLAND AVENUE N W.

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1 53 t

i bafore us. If you tell us that cardiologists only nosd 2 three months of training, I don't want to hear it because i

(

3 we know that that's what you're going to say and we may 4 even agree with you, but it's not germane to what we're 5 talking about today. So , try to focus. If you do it in 6 less than five, we'll appreciate it.

7 i DR. CERQUEIRA: Well, I'll certainly ;

8 try.

9 On behalf of the American College of 10 Cardiology and the American Society of Nuclear Cardiology, 11 I'd like to thank the esteemed Chairman Siegel and the

{

12 rest of the --

,_ 13 CHAIRMAN SIEGEL: I don't mean to l

'( ,/ 14 interrupt you. Esteemed chairman. I remember a few years 15 ago when the name of one of our major corporations was --

16 people started to think it was known as ailing Chrysler.

17 I'm starting to wonder whether esteemed chairman is --

18 DR. CERQUEIRA: Well, I'm just 19 following up on Barry's -- and the rest of the Advisory 20 Committee for giving me this opportunity to address the 21 issue of training and experience criteria for authorized 22 user. My comments will be general rather than trying to 23 deal with the specifics that have been discussed during 24 the last half hour.

.fm 25

) The mission of both the College and NEAL R. GROSS COURT REPORTERS AND TRANSCNSERS 1333 RH00E 18 LAND AVENUE, N W.

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54 1 the Amaricen Society cf Nuclear Cardiology is to fontor 7 2 the optimal medical care for patients through professional

(

\- 3 education, development of standards and the formulation of 4 health care policy. We are in complete agreement with the 5 Committee about the importance of radiation safety in the 6 use of nuclear cardiology procedures. Stipulating a 7 certain number of hours or months for training was 8 developed as a vehicle to ensure an adequate level of 9 training necessary for public health and safety.

10 Our organizations have always 11 maintained that a nuclear cardiologist is concerned only 12 with the imaging of a single organ system, that is the 13 heart, and in maintaining a radiation risk to the patient 14 that is as low as is reasonably possible.

15 We believe that the previously 16 acceptable practice of allowing physicians to concurrently 17 complete their required supervised clinical and work 18 experience has worked well and is sufficient to assure 19 radiation safety and the practice of nuclear cardiology.

20 To change this policy is potentially arbitrary and 21 restrictive. Furthermore, we have no knowledge of any 22 serious violations of radiation safety among nuclear

, 23 cardiologists who are lic:ased under the current 24 interpretation of the regulations.

25 Our concern is that the ACMUI NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 MH00E ISLAND AVENUE, N W.

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55 1

reviewars may experience a conflict of interest in judging

( 2 the applications that are brought before the Committee. A

s

! V, 3

discussion of turf, as happened at the last ACMUI meeting, 4 clearly demonstrates the validity of this concern. The 5 College and the American Society of Nuclear Cardiology 6 strongly recommends that the Committee maintain the 7 current method of licensing that recognizes concurrent 8 training as a viable and accepted standard. However, if 9

the Committee decides to move forward with their review of 10 each exemption that is presented to it, we would support 11 the review of nuclear cardiologist's credentials being !

12 done only by individuals with board certification in both p 13 cardiology and nuclear medicine and/or radiology.

U 14 We look forward to the review of the 15 current regulations by the National Academy of Sciences.

16 The American College of Cardiology and the American 17 Society of Nuclear Cardiology also look forward to working !

18 with the NRC staff and the Advisory Committee on the most 19 effective training for our members that will ensure the i 20 highest level of radiation safety both to the physicians 21 and to the general public.

22 Thank you very much.

23 CHAIRMAN SIEGEL: Manny, thank you.

24 Let me ask you a question. l l

i

\v 25 DR. CERQUEIRA: Sure. !

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i 56 1

CHAIRMAN SIEGEL: Your statement i

2 about who should review, repeat that again?

O 3 DR. CERQUEIRA: Well, it's our l

4 feeling that basically we should have a cardiologist and 5 somebody who is also board certified in nuclear medicine 6 and/or radiology to review it to avoid some of the turf 7 issues that were clearly obvious during the last ,

8 discussion.

9 CHAIRMAN SIEGEL: Yes. I think the 10 notion that we would entertain as this Committee an 11 application from a cardiologist for an exemption and 12 exclude Dr. Berman from the discussion is incredible to

-~g 13 me. Under no circumstances would I allow that to be 14 conducted. If we were planning a conference call review 15 of such a thing and Dr. Berman was unavailable, I would 16 insist on it being rescheduled.

17 So, the suggestion that this 18 Committee's activities would be designed to restrain trade 19 I find a little bit offensive.

20 DR. CERQUEIRA: Yes.

21 CHAIRMAN SIEGEL: We want to state 22 for the record that the approach that this Committee would 23 take so long as I help to guide what it does will be as 24 fair as possible, as fair as reasonably achievable.

s 25 That's AFARA.

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57 1

DR. CERQUEIRA: Well, that's very s 2 reassuring information. We certainly weren't implying t

\s) 3 that the Committee would in any way deal with the issue in 4

any manner other than what you've just described very 5 eloquently.

6 CHAIRMAN SIEGEL: Bob?

7 MEMBER QUILLIN: Since I represent 8 the Agreement States which actually will look at more of 9 these than the NRC will look at, and since I have a role 10 of trying to be a liaison between this Committee and the 11 Agreement States, I also think somewhat umbrage at the 12- comment that only two groups should look at this and these

, 13 kinds of applications because it's really necessary for me N./

s 14 in my role on this Committee to let the Agreement States 15 know what the ACMUI is thinking. I 16 DR. CERQUEIRA: You're right.

17 CHAIRMAN SIEGEL: So , having heard 18 that and having heard your comments, let me suggest the 19 following, and this is not a position I had until I've j 20 heard this discussion. I would suggest that the way we l 21 ought to handle these exemptions is that we ought to do it L 22 as a committee of the whole so that we have all the ;

23 representation and we have the full wisdom and expertise 24 cf all the people on this Committee., that we should do 25 that as many as possible as part of. our biannual meetings NEAL R. GROSS COURT REPORTERS AND TRANSCRISERC 1323 AM00E ISLAND AVENUE. N W.

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58 1 as wa can cram into those meetings and when we need to do 2 more that we do it by noticed conference call meetings so 3 that we can have participation of all of us who are 4 available at that moment to participate in the discussion.

5 I'm concerned that the paper reviews 6 will deny each of us from the wisdom of the other person's

~

7 point of view and assessment of the training and 8 experience of that individual. I also believe that the 9 desire for having the whole Committee involved is 10 motivated by bringing the whole Committee up to speed for 11 the major debate which is going to be --

12 DR. CERQUEIRA: My only comment to 13 that, Barry, would be that you'd like to get a procedure b)

(__/ 14 that would have a relatively good turnaround time. What 15 you're proposing would be somewhat cumbersome in the sense 16 of getting --

17 CHAIRMAN SIEGEL: We all have 18 telephones. Most of these individual exemptions can be 19 dealt with. In past experience they've been very short 20 meetings.

21 DR. CERQUEIRA: But the Committee 22 has what, 17 members?

23 CHAIRMAN SIEGEL: What?

24 DR. CERQUEIRA: How many members are

/'~ N i 25 on the Committee?

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59 1 CHAIP. MAN SIEGEL: There are actually e-~s 2 only 12 or 13 at the moment and we need, therefore, more 3 than half for a quorum according to our rules. We would 4 make certain that a quorum would include individuals with 5 the-- and we can discuss this procedurally, but if we were 1

6 doing a radiation oncology one, we wouldn't want the 7 quorum to exclude both Dr. Stitt and Dr. Flynn. I don't 8 think that's procedurally complicated and I think that 9 there is real benefit to having t'1 whole committee 10 involved. But I'd be willing to see what other people 11 think. I 12 MEMBER SWANSON: I would agree with 13 you. In lieu of a specific set of criteria to evaluate

\

N- 14 the exemptions, if you start farming these out to groups 15 of individuals you have the opportunity to enter bias into 16 the decision making process or unevenness into the 17 decision making process. Therefore, I think it has to be ,

1 18 reviewed by the total cor.mittee. I 19 MEMBER WOODBURY: I agree that the 20 Committee as a whole would be the way to go. The problem 21 I have is the same question we raised earlier is the 22 volume. For instance, if you have 500 of these to do in a 23 quarter or half year or even at one of these meetings, it 24 'would take up the whole meeting. Nothing else would get O( ,/ 25 done. So, that's why trying to assess the volume that NEAL R. GROSS COUMT MEPORTERS AND TMANSCMSERS 1323 MMODE ISLAND AVENUE, N W.

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60

-1 you're talking about is'--

2 CHAIRMAN SIEGEL: I'm willing to V 3 take that risk.

4 MEMBER BERMAN: But you're really 5 talking -- I believe; as I mentioned before, you're 6 dealing with potentially a few hundred.of these. I 7 believe it's going to take a tremendous amount of time. I 8 also believe that if we try to do this by telephone 9 conference call, it's going to be very difficult. What 10 Dr. Cerqueira mentioned, which is that because of that 11 difficulty that this might just add another impediment in 12 the process, you'd think that what could end up happening 13 is that people who are applying for licenses might end up (3

\s_/ 14 with six month to a year's extra delay because of the 15 process that we're now putting in place.

16 CHAIRMAN SIEGEL: I don't think that 17 the process has required that time in the past when it's 18 been involved. But tell me what you would propose --

19 which of the strategies you find more executable, Dan?

20 MEMBER BERMAN: Well, it has to come 21 out on the table. I think that at some point in time this 22 Committee of 12 needs five minutes, 10 minutes, 15 minutes 23 of discussion so that they'll be able to process 25 or 30 24 applications. We are dealing with a concept that there l

(/~%) 25 are 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of work experience that deals predominantly NEAL R. GROSS j COURT REPORTERS AND TRANSCRGERS 1333 RMODE IEd.AND AVENUE, N W.

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61 1

with radiation safety, a concept that doesn't even apply 2

to nuclear medicine residents or to radiology residents.

3 Nobody spends that much time monitoring packages. If that 4 concept is just going to be not discussed, I think we are 5

closing off discussion unnecessarily.

6 CHAIRMAN SIEGEL: This Advisory 7

Committee does not have the authority to change the code 8 of Federal Regulations.

9 MEMBER BERMAN: I'm not asking for 10 that.

What I am saying -- but 1200 hours0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months is equal to 6.92 11 months. It's more than six months. 1200 hours0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months at 40 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months a week is not a six month time. There already is, 13 as you've pointed out, evidence that some degree of g .14 concurrence on this training is acceptable. What we're 15 trying to define is how much is reasonable. Sally 16 recently told us that during the time that you've had 17 tenure on this Committee this group has met, has reviewed is applicants who did not meet the 1200 hours0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months , looked at the 19 training and said it was adequate. So, this exception has 20 already been taken in the past by this Committee. I think 21 it's unrealistic to assume that the cardiologists of the 22 world who are interested in training who do 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months , 23 which is four months, and that would be with complete 24 concurrence, would do that four months of training, it 25 would be unrealistic to assume that they're not going to NEAL R. GROSS couar aponvras Ano rauscaeEas 1333 aMoOE ELAND AVENUE, N W.

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62 1 apply. So, they're going to apply based on past precedent 2 and we're going to have to evaluate them. I think we need

(_s\

\m / 3 to do it as a Committee as a whole, but 1 think we need 4 some kind of understanding as to what might be an 5 appropriate minimum amount of time that's acceptable.

6 MEMBER NELP: I perceive you can't 7 take exemptions and set rules for exemptions. I thought 8 Manny's statement was a very reasonable statement. It {

9 seemed to be in line with the current regs. and we can't 10 change the regulations, but we also can't sit around and ;

1 11 say, "Okay, we're going to agree as a Committee as a whole 12 that three months is it."

,_ 13 MEMBER BERMAN: Three months is not

s. 14 even on the table.

15 DR. CERQUEIRA: We didn't talk about 16 times.

17 MEMDER NELP: I'm not referring to 18 Manny's statement. I'm referring --

19 MEMBER BERMAN: But you and Barry 20 both referred to three months and three months is not even 21 up for -- nobody is asking for that. I 22 MEMBER NELP: That's merely an !

23 expression. That's an off-the-cuff remark. I don't know l l

24 what it should be. But it would seem very difficult for

.Q

( j 25 us as a Committee to come up and set guidelines for NEAL R. GROSS COURT REPORTERS AND TRANSCRGERS 1323 RHOOE ISLAND AVENUE, N W.

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63 1 exemption. I think they should be handled -- I haven't p-~s 2 seen -- I'm a new guy on the block. I've been here what, i

's) 3 a year and a half? I haven't seen one of these items come 4 to the table.

5 DR. CERQUEIRA: That's a good point 6 in the sense that the way the procedure is being carried 7 out by Larry's committee with the interpretation has not 8 resulted in any problems or any violations. We're not 9 aware of any serious misadministration or radiation risks.

10 So, I think Larry is trying to get clarification and I 11 don't see what was wrong with the method that was being !

12 used.

,~s 13 MEMBER NELP: You're saying that m 14 he's been doing a fine job.

15 DR. CERQUEIRA: He's been doing a 16 great job.

17 MEMBER BERMAN: But the problem is 18 that we changed it our last meeting. When Larry brought 19 to the table the fact that concurrence was allowed to 20 varying degrees in the field and wanting some 21 clarification of that, that's when our Committee rejected 22 that, except for my vote. What we found out now, they're 23 going to be coming forward and that's what we're dealing 24 with.

(v) 25 DR. CERQUEIRA: And I think we're NEAL R. GROSS COURT REPORTER $ AND TRANSCMSERS 1323 AMODE 18 LAND AVENUE, N.W.

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64 i

sort of potentially burdening this Committee with a lot of i

r~' 2 problems that have not really been problems.

\

3 MEMBER NELP: I think what Barry has 4

said is let's don't change the rules until you go through 5 this very critical review that's going to expose the whole 6 system of regulations and see how it fits because we'll 7 just be --

8 DR. CERQUEIRA: But in the meantime 9 it would be reasonable to let Larry's committee continue 10 to do as they've done in the past, which is to basically 11 deal with the issues.

12 MEMBER NELP: We didn't advise them *

- 13 in any way that they couldn't do that.

l 14 MR. CAMPER: No. Actually, I think 15 l you did. What you have here is a classic situation where ;

16 the sleeping dog is no longer asleep.

17 MEMBER NELP: Oh, come on.

18 MR. CAMPER: The dog has been I

19 kicked. The truth of the matter is that for years we have 20 processed these applications. I've already acknowledged 21 unfortunately that there was some lack of uniformity in 22 how they were processed amongst the various regions. I'm 23 not critical of the regions for doing that because I 24 think, in fact, there hasn't been adequate guidance from 25 Headquarters on the subject, j NEAL R. GROSS l' CouPT REPORTERS AND TRAN6CRISERS 1323 MH006 ISLAND AVENUE, N W (202) 234-6433 WASHINGTON O C. 20006 (202) 234-6433 j

1 I

65 1 1

But as time has marched on and there i

f-'s 2 is more interested in physicians becoming authorized j

' ~ ,

3 users, as the question of what does concurrent mean as it -

4 gets interpreted, the dog was kicked awake. Then we found 5 ourselves in a situation of trying to develop a model to i

6 facilitate the processing of these applications for the 7 very reasons that are being talked about now. We've i l

8 brought that model to this Committee. The Committee had a 9 resolution that it did not want to entertain that model, 10 rather it wanted to have these things reviewed on a case 11 by case basis.

12 So, the concept of our regional 13 personnel continuing to review these things in the absence

-~3

\'- 14 of further guidance is history.

15 CHAIRMAN SIEGEL: Okay.

i 16 MEMBER NELP: Now, wait a minute. We're an 17 advisory. committee, Larry. You can accept our advice or !

18 not and you can go ahead and run your program as you see i

19 appropriate for the issues and the problems. !

20 CHAIRMAN SIEGEL: Big risk.

21 MEMBER NELP: Dr. Cerqueira just told me and ;

22 he told you that you're doing a very fine job.

23 MR. CAMPER: Well, thank you, sir. We 24 appreciate that.

\ ,)

25 MEMBER NELP: And I would say continue to work NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVENUE. N W.

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66 1 as you have been.

~s 2 MR. CAMPER: Let me just make a record real 3 quick. The problem that we have though is you're 4 absolutely right. This Committee makes recommendations to 5 this Agency. We could have chosen to ignore or to 6 entertain bits and pieces of your resolution. We could 7 have continued to do it the way that we did it. You're 8 absolutely right.

9 The problem with that mindset though as a 10 regulator is this is about training and experience for 11 physicians. To ignore or to select only in part the 12 recommendation of this Committee that deals with such a 13 sensitive issue as physician training and experience when b

\s_s/ 14 this Committee is comprised primarily of physicians I 15 think would have been a very unwise thing to do as a 16 regulator.

17 MEMBER NELP: I agree. Your wisdom is well 18 recognized. We've said bring it to us and we'll help you.

19 That's all.

20 CHAIRMAN SIEGEL: Judy?

21 MEMBER NELP: Until this --

22 CHAIRMAN SIEGEL: We need closure here.

23 MEMBER NELP: -- Academy of Sciences thing is 24 reviewed and we're fine.

t'

) 25 CHAIRMAN SIEGEL: And I'm going to try to give NEAL R. GROSS COURT REPORTERS AND TRANSCRISER$

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~

67 1 us closure.

2 MEMBER BROWN: Is NRC expecting a big increase

\- ' 3 in the number of exemptions --

4 CHAIRMAN SIEGEL: Oh, you bet. <

5 MEMBER BROWN: -- permitted because word is 6 now on the street that there are these exemptions and why 7 wouldn't anybody apply for a lower standard if they could?

8 DR. CERQUEIRA: I don't think the word on the 9 street has changed in any way.

10 CRAIRMAN SIEGEL: The mail trucks are outside 11 right now.

12 MEMBER NELP: I think Larry kicked the dog.

13 DR. CERQUEIRA: Well, we're in a situation O-s_ 14 where we have people who want to come into the field. We 15 have no evidence that they are misadministering 16 radioactive compounds, so we should be happy that people 17 want to get into it.

18 MR. CAMPER: Let me make, again, one comment 19 for the record so there's no confusion.

20 MEMBER BROWN: So it's only the people in the l

21 know that can apply for these exemptions and get in under 22 the lower standards. Other people are just kind of --

23 DR. CERQUEIRA: Well, I wouldn't call them 24 lower standards. There's been no evidence that people are

(~ ~

25 coming in unqualified.

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)

68 1 MEMBER BROWN: Well, they wouldn't be applying 2 for an exemption if they had more than the required

~'

3 training, right?

4 DR. CERQUEIRA: Well, that gets back to Dr.

5 Siegel's point as to the basis upon which those standards 6 were established. It may be that it's overkill.

7 CHAIRMAN SIEGEL: Let me suggest the 8 following.

9 DR. CERQUEIRA: Sure.

10 CHAIRMAN SIEGEL: Let me suggest first of all 11 that the procedure by which this Committee ought to 12 develop an approach for granting exemptions with really 13 figuring out what we want to do while you're still O' 14 worrying about how you're going to change Part 35 at some 15 distant time in the future, if you really want us to do 16 that and you want us to have this debate, that you should 17 schedule some time in the spring, and we've already got 18 one meeting on for the spring plus the other regular one.

19 Let's schedule another meeting. Let's schedule a full two 20 or three day meeting to include public testimony from all 21 the interested parties like occurred at the Holiday Inn 22 Bethesda 12 years ago, whenever that meeting was, when at 23 the time the current regulations got cast in concrete and 24 then let's create a set of exemptions based on that 25 meeting that we can use as our operating posture for 1996 NEAL R. GFH3SS COURT REPORTERS AND TRANSCRISERS 1323 RH00E ISLAND AVENUE, N W.

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69 1 while you work forward to a rewrite of Part 35, ideally e s 2 based on the information that came out at that meeting.

3 So, I put that suggestion on the table. We 4 need another meeting like we need a hole in the head and I 5 need that meeting on my watch like I need a hole in the 6 head. But nonetheless, I think that that will satisfy the 7 concerns that have been expressed if we really debate the 8 issues fully.

9 Procedurally we have a more important question i

10 to address. It seems to me we need to consider whether we 11 want to do this one of three ways. Way number 1 is to 12 accept the idea that we do paper reviews. On the other s 13 extreme, number 3 is to go with the concept of Committee s

~> 14 as a whole which has some advantages, a learning process, .

i 15 but admittedly is chunky.

16 Way number 3 is for us to design right this 17 moment basically two subcommittees. Subcommittee one I 18 relates to nuclear medicine and subcommittee two relates 19 to radiation oncology. I would propose that the nuclear 20 medicine subcommittee be compoced of Dr. Berman, Dr. Nelp, 21 myself, Dr. Woodbury, Dr. Wagner and Dennis Swanson, Bob 22 Quillin who should sit on both subcommittees. The 23 radiation oncology subcommittee should be Dr. Flynn, who 24 is not here, Dr. Stitt, the new radiation oncology O)

( 25 physicist and Mr. Quillin. Judy can si'. on either or none NEAL R. GROSS COURT REPORTERS AND TRANSCRieERS 1323 RHODE ISLAND AVENOE, N W.

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70 1 or both, whichaver she prefers, and we can do it.

fs s 2 That will be -- it will be easier to organize

\ 3 conference calls of a smaller group of people than it will 4 be of a larger group of people. It will meet the 5 requirements for Federal Advisory Committee Act and we can 6 do it. So, I think we've got three strategies.

7 DR. CERQUEIRA: I'd propose there be a fourth 8 also in the sense that the NAS recommendations are going i 9 to be coming. So, any sort of conference to make changes 10 may be influenced by what happens. Why change what has '

11 been working? Why not continue what was being done in the 12 past until you get the NAS recommendations and then at l

13 i that point review the process?

,r k,,e 14 MEMBER NELP: I would like to make a motion 15 that we accept Barry's number 3 suggestion of having two 16 subcommittees to, on an interim basis, deal with the 17 issues. We'll see what the issues are and then we can be 18 flexible. If we need to change that, that's fine. I so 19 move.

l 20 MR. CAMPER: I have a clarification question, 21 Barry. You're saying -- for the record, you're looking at 22 two committees, two subcommittees that would review the 23 actual requests for exemptions or review submitted 24 training experience, right?

O (b' 25 CHAIRMAN SIEGEL: Correct.

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71 1 MEMBER NELP: As you see fit.

< We only want to

~, 2 review the things that you feel are problematic. We don't

'N_- 3 want to do your work for you. We want you to bring to us 4 issues that you or the people in the field think need 5 additional attention.

6 MEMBER BERMAN: But could I clarify what 7 you're saying? Its seems to be a little discrepancy.

8 What they were doing up until recently was --

9 Larry, I wanted you to catch this. Up until recently what 10 they were doing was accepting at a certain degree of 11 concurrence and that was -- as you're pointing out, that 12 was working. What we decided at our last meeting was we

,,, 1.~- were going to say, "No, you can't do that anymore."

/

14 MEMBER NELP: No, we advised them of our i

15 opinion. They have no constraints about following that l 16 advice and I imagine they've continued to operate as they 17 have. I 18 MEMBER BERMAN: I don't think so actually, 19 MEMBER NELP: And in the regulations, they can 20 grant exemptions and if they have problems with that in 21 terms of the qualifications of individuals, then I think 22 it's very reasonable that we could help them --

23 MEMBER BERMAN: But on the interim basis, 24 until we have the meeting, the excellent meeting that fs_ 25 Barry suggested --

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~

l 72 1- MEMBER NELP: That won't change the i 2 regulation. That meeting will just vent a lot of

/s t

%- 3 expression and give a lot of direction, but it won't 4 change any regulations.

5 MEMBER BERMAN: Right. But the meeting that 6 Barry described will actually, I think, get a lot of l 1

I 7 discussion that will clarify how the subcommittees might i 8 work. But until that time, are you suggesting that our !

9 subcommittees, you're going to look at everything or would 10 you be willing to let Larry's group or to advise them ;

11 that--

12 MEMBER NELP: I think Larry has a 13 responsibility as the director of a certain component of 1 i

sm _- 14 the NRC and one of his responsibilities is to look at 15 these things and if he has a problem that he feels he 16 can't deal with, we'd be happy to. assist him. But I think 17 he's very capable to grant exemptions and my motion is if i

18 he feels that our advice is so strong that he wants us to 19 look at them, then a subcommittee evaluation would be 20 appropriate.

21 MEMBER BERMAN: Okay.

22 CHAIRMAN SIEGEL: He's required to get the 23 ACMUI to look at exemptions by Part 35 as it currently 24 stands.

25 MEMBER NELP: But he hasn't done this in the NEAL R. GROSS COURT REPORTERS AND TRANSC. 9 0ER$

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73 1 past.

,_ 2 MR. CAMPER: Because we didn't grant I

k_ 3 exemptions.

4 MEMBER NELP: Oh, I thought you did.

5 MR. CAMPER: No. What we did was --

6 MEMBER NELP: You granted concurrence.

7 MR. CAMPER: Our reviewers reviewed the 8 submitted training and experience of an applicant and they 9 came to closure given the guidance that they had to work 10 with, which I've already indicated was minimal on this 11 question of what constitutes concurrence. Now, what has 12 happened is as this issue has continued to escalate, we 13 have now recently been provided with an interpretation by (s l 14 the office of General Counsel that the regulations as "

15 currently written require 200, 500 and 500. If you're

. I 16 going to authorize a physician user who presents less 17 hours than that, you will do so through the mechanism of ;

l 18 an exemption.

19 Now, if I turn to 35.19, it tells me that if 20 I'm going to grant --

if the Commission is going to grant l 1

21 exemptions that deal with physician training and 22 experience, I will grant those exemptions in concert with 23 assistance from the Advisory Committee on the Medical Uses 24 of Isotopes. The assistance that the Advisory Committee O)

(V 25 has offered in your last resolution in your last meeting NEAL R. GROSS COURT REPORTERS AND TRANSCRaSERS 1323 RHOOE ISLAND AVENUE, N W.

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74 1

was we do not want to entertain a model for establishing

, , 2 concurrence. Rather, we want to see each and every

(

\ 3 application. That's the assistance that you've offered.

4 MEMBER NELP: Correct.

5 MR. CAMPER: We have accepted that assistance 6 and we are proceeding to develop the procedure to 7 implement your recommendation.

8 MEMBER NELP: And I made a motion that we 9 would like to provide that assistance through the use of 10 subcommittees. We'll evaluate the problem, come up with a 11 working solution and I look for a second.

12 CHAIRMAN SIEGEL: Was there a second?

13 MEMBER WAGNER: I'll second that.

O k_s s 14 CHAIRMAN SIEGEL: Okay. Lou, you've been 15 chomping at the bit for awhile.

16 MEMBER WAGNER: I would like to see the 17 Committee move on with its business. We are not going to 18 solve this issue at this meeting. We are an hour behind 19 time and the facts are that I personally would not want to 20 make any decisions until I start reviewing some of these 21 cases. Sally has said before that we can change these 22 rules midstream if we want to in terms of how we're going 23 to review these things. At this time, I don't think this 24 Committee wants to go ahead and make a whole lot of ideas 25 about what we're going to do until the whole Committee NEAL R. GROSS COURT REPORTERS AND TRANSCM6BERS 1323 RMODE ISLAND AVENUE. N W (202) 234 6433 WASHINGTON. D C. 20006 (202) 234 4433

75 1 sees soms applications and can make some decisions.

2 CHAIRMAN SIEGEL:

The motion has been made and

/h

(~~/ 3 seconded that the process for review of exemptions be by 4 subcommittee. At least for the moment, let's say that the 5 subcommittee composition is as articulated by me a few 6 moments ago. Is there further discussion on this motion?

7 All in favor of the motion, indicate by saying 8 aye.

9 (Ayes.)

10 CHAIRMAN SIEGEL: All opposed?

11 (No response.)

12 CRAIRMAN SIEGEL: Okay. So, the motion is 13 passed. That's the procedure we've adopted and I take

'[,_,h (m,/ 14 that to mean that we choose not to do paper reviews and we 15 choose not to act as a Committee as a whole. I suppose 16 it's conceivable that the subcommittees may find that 17 something is sufficiently contentious that they'll want to 18 refer it to the whole Committee.

19 MEMBER NELP: I think the subcommittees will 20 fully inform the Committee.

21 CHAIRMAN SIEGEL: But I think they'll do it.

22 Now, let me ask the Committee before we move j 23 on how the rest of you feel about my suggestion for more 24 work, that rather important political battle and it gets

( 25 to the heart of the philosophy of an important regulatory NEAL R. GROSS covar aEeCarsas ANo TamscaseEas 1323 aHOOE ISLAND AVENLT. N W.

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76 1 issue. It was debated at great length 12 years ago.

2 There are certain elements on the sides of the different

(,,/ 3 turf battles that will still feel the same way they did 12 4 or 15 years ago. I think there are others who taking an 5 approach for reengineering the government and deregulation 6 will argue for less role for the NRC in this. We just 7 need to have the debate.

8 MEMBER BERMAN: I think it's an excellent 9 suggestion. What Larry just told us a couple minutes ago 10 of about now the counsel saying that you need 1200 hours0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months 11 means that all the radiologists who are being trained with 12 their six months aren't meeting the 1200 hour0.0139 days 0.333 hours 0.00198 weeks 4.566e-4 months requirement.

13 So, really you've got -- you have a big problem that has

.p

( 14 opened up. ;

15 MEMBER NELP: That was a piece of advice. We 16 didn't change anything.

17 MEMBER BERMAN: No, no. I'm not suggesting we .

)

18 change anything. What I'm suggesting is that this debate 19 is really needed and I strongly support Dr. Siegel's 20 suggestion.

21 MEMBER NELP: And I would like to add one more 22 thing, Barry.

23 The next time we meet, Larry, I would like to 24 have the data. I would like to know the numbers. I would

[j\

\

25 like to know the position of your people out in the field.

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77 1

Wa're decling with soms nebulous figure and I'd like you 2 to try to quantitate the extent of the situation so we 7-(N '/ 3 know what the heck we're dealing with because it's sort of 4 nebulous.

5 MR. CAMPER: All right. We can certainly do 6 that.

7 MEMBER NELP: I know it's there and you have a 8 better feeling for it than I do.

9 MR. CAMPER: We can certainly attempt to do 10 that. Let me just make one more closing comment about 11 this. I think, frankly, if we do add on a day to discuss 12 this training and experience issue as a follow-on to the l

13 meeting talking about the NAS, I like the idea that when !

[

14 we go to talk to the professional groups that have an 15 interest, the endocrinologists and the cardiologists and 16 the radiologists, et cetera, et cetera, that we will have 17 pulsed the ACMUI and can say, "The ACMUI, we shared this 1

18 information and this was generally their recommendations l

19 and their perspectives." I think that would facilitate l

20 that discussion frankly. So, we can think more about !

21 that. l 22 CHAIRMAN SIEGEL: Good. l i

23 DR. CERQUEIRA: I'd like to thank Dr. Siegel I 24 and the Committee for hearing our request. We'd like to .

7g I

(-)

s 25 be actively involved in future discussions.

j NEAL R. GROSS COURT REPORTER 8 AND TRANSCRISERS l 1323 RHODE ISLAND AVENUE. N W.

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78 1 CHAIRMAN SIEGEL: I don't doubt that you will 2 be.

3 DR. CERQUEIRA: Thank you, Barry.

4 CHAIRMAN SIEGEL: Yes. We are going to take a 5 break. The rulemaking update probably will only take 6 about a half an hour. We're behind schedule, but we're 7 going to do some catch-up. So, a ten minute break.

8 (Whereupon, at 10:19 a.m., off the 9 record.)

10 CHAIRMAN SIEGEL: We have a quorum and we have 11 at least one federal -- now we have both federal 12 officials, so we can proceed.

p-ss 13 We are going to go on with the update on

~~ 14 rulemakings and guidance. And then we are going to 15 continue directly changing the agenda with the petition j As for rulemaking, 1130 item and we're going to shift the 17 intravascular brachytherapy to follow. Jim Smith said 18 that would work for him.

19 And so, Cheryl Trottier, go for it.

20 MS. TROTTIER: Thank you. First, I feel like 21 I should warn you. I found out about this yesterday 22 morning. Because at the beginning of this session, I 23 think Dr. Cool explained the situation at MIT and that we 24 were doing this IIT team. Well, unfortunately, John Glenn f%

() 25 who is our normal branch chief, is heading up that team.

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79 1 And so now I am branch chief and I get to come to you and

,_,. 2 explain rulemakings that I know next to nothing about

\

\ 3 because I haven't been in the office for the last four 4 months. But, we'll get through it. I do have some of the 5 staff here. So, if there are any questions that I can't 6 deal with, I'm sure they'll be able to.

7 The first rulemaking is really just a real 8 quick update for you. You may already be aware of this, 9 that wrong patient was published in the Federal Recister.

10 The date is there on the slide, September 20th. I did not 11 make any overheads, again, because of this short notice.

12 And we did make some extra copies of the slides so anyone 13 from the public who doesn't have access to the slides that

\s 14 the committee has, can pick them up in the back. i i

15 Anyway, that was published in the Federal 16 Recister in September. So we are done with that.

17 CHAIRMAN SIEGEL: Any comments on that item, 18 folks? That was pretty much per our recommendation and 19 concurrence.

20 MS. TROTTIER: Yes, it was, l

21 CHAIRMAN SIEGEL: Yes. - g-22 MS. TROTTIER: All right. The next rulemaking I 23 is patient release. It's been changed somewhat since the 24 last time you saw it and what we have put together on the A

25 slides today is to show you what some of the changes are.

- NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RMODE ISLAND AVENUE. N W.

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80 1 I will tell you, first of all, it's current

/s 2 status'that it is on its way to our commission.

( It is

'~') 3 currently in our executive director's office. I would 4 anticipate that within a week, if all goes well, it should 5 make it up to the commission. But of course, it went to 6 the executive director's office in May and it's been back 7 several times. So anyway, I'll just run through some of ;

8 the changes that have been made to it as a result of his 9 concerns.

10 On the first slide, you'll notice there is a 11 proposed rule language and the previous proposed rule i 12 language. The main change there was to remove the phrase ;

s g 13 in parenthesis, including a breast feeding infant. It

~> 14 doesn't really make a significant change in the rule but 15 we're dealing with the breast feeding infant in guidance 16 space more than in rule language space. But when I get to 17 the next slide, I think you'll see that.

18 Then on the next slide, you'll see, again, the 19 proposed rule language is slightly different from what you 20 saw before. Around the middle of the paragraph, after the 21 ALARA statement, it says, "if the does to a breast feeding 22 infant or child could exceed 1 millisieverts, assuming 23 there were no interruption of breast feeding, that the 24 instruction should include guidance on interruption of 25 breast feeding and information on the consequences of NEAL R. GROSS count nearnas ANo in4Nacaissa 1323 nH00E ISLAND AVENUE. N W.

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81 1 failure to follow the guidance." That is the change that fs 2 is in the package that is currently in the EDO's office.

(

\- 3 MEMBER WOODBURY: Consequences to whom?

l 4 MS. TROTTIER: Consequences to the infant, or 5 a child, in either case. The breast feeding individual. ;

6 CHAIRMAN SIEGEL: Dennis?

7 MEMBER SWANSON: I had a comment on the second 8 part which is actually added. I think the information on 9 the consequences of failure to follow the guidance. As 10 chairman of the radiation safety committee at our 1

11 institution, human use subcommittee, I've been trying to 12 come up with statements of risk associated with radiation 13 exposure. And to be honest with you, I'm not sure what.

Og <

\

As/ 14 information on the consequences of failure to follow the 15 guidance I can give to a mother. If their infant is 16 exposed to 200 millirems of radiation, what are the 17 consequences of that in consideration of the fact that i

18 their annual radiation exposure is 300 millirems? And so, 19 I think I mean, you're kind of leaving us there with a 20 difficult situation to try to explain in many cases. I 21 mean, I can explain 5 rads exposure but I'm not quite sure 22 how to deal with that.

23 MS. TROTTIER: I understand. Now, again, as I

)

24 said, since I was not here, maybe -- Larry, do you have a f} 25 view on why we chose the phrase that we chose on this?

(V ,

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82l 1 CHAIRMAN SIEGEL: This has been in again and

[N 2 out again a couple of times.

\

v) 3 MS. TROTTIER: In again and out.

4 MR. CAMPER: I would ask Dr. Holahan. She was 5 actively involved in that.

6 Trish, do you recall exactly why?

7 CHAIRMTR SIEGEL: Or Stuart may know.

8 MR. CAMrER: Or Stuart may know.

9 MR. SCHNEIDER: Has to do specifically with i

10 the thyroid in the breast feeding infant.

11 CHAIRMAN SIEGEL: Right, Stuart, and I 12 recognize that. That was Stuart Schneider, by the way,

(g 13 for the record.

l 14 The problem is, is exactly what Dennis said.

15 Clearly, if someone being treated with I-131 who had been 16 breast feeding, and I chose those words carefully, I would 17 tell that mother, you may not breast feed any longer 18 because if you do, you will wipe out your infant's thyroid 19 gland. !

20 The problem, on the other hand, though is if

((c63 21 someone's going to have a study with technetium kb"' i 22 pertechnetate where most tables would recommend that i

23 ceasing breast feeding for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months is the strategy to get i 24 the effective dose below 100 millirems, I would have

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83 1

instruction, here are the consequences. .. And ece,rifgyou, f^ 2 dnsistron7this 1angshbEP 7 hinih'5? NRC 2 ffaiiIh$ N willingeto

(

\ i 3 . a c cep t s t he ;,f ollowing sin .' writ teWf6 snuct i'ans . We !

4 recommend that you discontinue breast feeding for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months 5 because we subscribe to the policy of maintaining doses as 6 low as reasonably achievable. If you do not follow these 7 instructions, it is unlikely or it is impossible to prove '

1 8 that any adverse consequences to your infant will result. !

J 9 Because I would insist on wanting to write that because I i 10 can't honestly tell a patient that 140 millirem dose to 11 her infant will harm that infant any more than I could 1

12 tell that patient that the 300 millirem effective dose to l l

fs 13 her from the study will harm her.

)

i,'- 14 MS. TROTTIER: Correct.

15 CHAIRMAN SIEGEL: And that's why I had i

16 objected to this phrase in this part of the rule previous.

17 And I guess I'm objecting to it again.

18 MR. CAMPER: Trish?

19 MS. TROTTIER: Trish? !

I 20 DR. HOLAHAN: It is my understanding that in 21 the reg guide basically what you're saying there, Barry, 22 in terms of that as much could be done in terms of the 23 consequences, we recommend that you discontinue for 24 24 hours to avoid, otherwise your baby may receive some C

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84 1 are no expected consequences if you don't stop breast 7- 2 feeding. And that is what was meant in terms of (d/ 3 consequences. Because no consequence is also a 4 consequence.

5 CHAIRMAN SIEGEL: Why not change that? Why 6 not say information on the consequences or lack thereof of 7 failure to follow the guidance?

8 See, I'm concerned that license -- I know 9 you're not going to put those words in because OGC will 10 never let it stand. But I'm concerned that licensees, and 11 more importantly, inspectors, will interpret this to mean ,

12 there better be a statement about the consequences and )

13 they better -- it better be based on the linear hypothesis v 14 rather than the linear quadratic or I could ' include a 4 i

15 consequence based on a hermetic hypothesis which would say 16 this will benefit your infant.

17 MS. TROTTIER: Yes. Well, I think, in fact, 18 when I first looked at this slide yesterday, that this is 19 a subject that we probably need to include in the 20 regulatory guide. It's not in there now but I do think 21 there's some guidance and the staff is telling me 22 inspection guidance also. So, there are mechanisms that 23 we can use to make it clear to both inspectors and 24 licensees what the staff intended by those words.

25 Hopefully that will solve that problem.

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85 1 MEMBER SWANSON: As a committee member, I'd 2 just like to make the recommendation that the sentence 3 end, guidance on interruption on breast feeding, period, 4 which could certainly include consequences if there are 5 expected consequences of that. ' "I*Tl*'4 (2) ~

6 CHAIRMAN SIEGEL: Qu icasct -

Are you making that as a g 4

7 I'm not sure whether we've got any option at this poin i 8 given the way this package is. But that doesn't preve 9 us from making the motion.

10 MR. CAMPER: No, it does not.

11 MS. TROTTIER: No, you can make it.

12 MEMBER SWANSON: I would like to make that 13 motion.

14 MEMBER WOODBURY: I second it.

15 CHAIRMAN SIEGEL: Is there a second?

16 MEMBER WOODBURY: Second.

17 CHAIRMAN SIEGEL: Is there further discussion?

18 Judith?

19 MEMBER BROWN: I'm going to abstain. I 20 haven't really given this enough thought to make a quick 21 decision.

Sorry.

22 CHAIRMAN SIEGEL: I think -- Let me speak on 23 your behalf, even without -- Because I --

No, having 24 understood --

25 MEMBER BROWN: I trust you on that, Barry.

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85 1 MEMBER SWANSON: As a committee member, I'd p

2 just like to make the recommendation that the sentence

\'v/ 3 end, guidance on interruption on breast feeding, period, 4 which could certainly include consequences if there are 5 expected consequences of that.

6 CHAIRMAN SIEGEL: Are you making that as a --

7 I'm not sure whether we've got any option at this point, 8 given the way this package is. But that doesn't prevent 9 us from making the motion.

10 MR. CAMPER: No, it does not.

11 MS. TROTTIER: No, you can make it.

~2 2 MEMBER SWANSON: I would like to make that 13 motion.

(-/

s_- 14 MEMBER WOODBURY: I second it.

15 CHAIRMAN SIEGEL: Is there a second? s l

16 MEMBER WOODBURY: Second.

17 CHAIRMAN SIEGEL: Is there further discussion?

18 Judith?

19 MEMBER BROWN: I'm going to abstain. I 20 haven't really given this enough thought to make a quick 21 decision.

Sorry.

22 CHAIRMAN SIEGEL: I think -- Let me speak on 23 your behalf, even without -- Because I -- No, having 24 understood --

bi 25

\] MEMBER BROWN: I trust you on that, Barry.

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a 86 1 CHAIRMAN SIEGEL: Yes, well, having understood 2

7- some of your concerns about this issue in the past, I

( )

\s / 3 think we are really all of a like mind here because I 4

think everybody on this committee, and I think the vast, 5 vast majority of medical licensees will not go out of 6 their way to harm infants who are breast feeding. And the 1

7 notion that you have to explain to someone the 8 radiological risks when there is no scientific basis for 9 making those statements is what we're trying to avoid I

10 here.

11 MEMBER BROWN: But it doesn't say radiological 12 risks. It just says consequences. So in the little box, 13 you say no consequences, right? They just want to make O

k,s 14 sure somebody paid attention to this aspect.

15 CHAIRMAN SIEGEL: The trouble, and I guess in I 16 a way, I would -- by forcing me to describe consequences, 17 it actually sort of limits my flexibility as a 4

18 practitioner. In a way, I'd like to be able to say i 19 although we really don't have any reason to think that 20 this will harm your child, we recommend keeping doses as 21 1ow as possible and as low as reasonable. And we strongly 22 encourage you to stop breast feeding for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months . Well, i 23 Doctor, what will happen if I don't? If then pressed with 24 that question, I said, there's really no scientific

()

O 25 evidence that anything will happen.

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87 1 put all of that complex language in my written

~

2 instruction, which I would be inclined to interpret that 3

this will then translate into what has to be in the 4

written instruction, that that's going to start confusing 5 patients. And I would --

6 MEMBER BROWN: I don't think anybody's going 7 to be confused by that. I think that just documents that

- 8 you paid attention to it. And, of course, you're going to 9 pay attention to that because you speak on my behalf. But 10 I'm not sure anybody else is. I mean, everybody else is.

11 MEMBER SWANSON: But.let me e,mphasize 12 something. By putting'in a written instruction that there

-~s 13 are no consequences, I'm concerned that that will distract I

\

\ -

14 from the precautions I've asked the patient to take. I J

15 would rather simply explain the precautions and not have !

16 to go on and say there are no consequences associated with 17 this because I actually think, as I said, by saying that 18 there's no consequences, that might distract from my 19 precaution ctatements. Se you might get a negative impact 20 there to what you're trying to achieve.

21 ,

CHAIRMAN SIEGEL: In other words, do what I 22 say but please note that there will be no benefit to doing 23 what I say. I'd rather not have to say that. What I'd 24 really like to say is, I'm the doctor. Do what I say.

A i 25 That's very paternalistic of me but in this case, I'd

( ,/ ,

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88 1 prefer to encourage the woman to do the right thing and

, , 2 not to spend a half an hour getting into which hypothesis

\

3 we're using of radiation risk.

4 Lou, do you --

5 MEMBER WAGNER: No, I fully concur with what 6 you're saying. The idea that there won't be any confusion 7 on the interpretation of on the consequences I think is 8 wrong. I think there will be tremendous confusion as tc 9 what that means, not only on the patient's part and the 10 physician's part, but also on the regulator's part. This 11 kind of a very nebulous phraseology is extremely 12 susceptible to misinterpretation.

13 MEMBER WOODBURY: I had no idea what it meant.

14 And if I'm a practitioner and I don't know what it means, 15 then I'm in trouble.

16 MR. CAMPER: Well, I think the problem is, if 17 you look at it, I think that the logic was, you have in 18 step 1 instructed interruption to breast feeding. The 19 patient may or may not --

may or may not grasp the 20 consequence of not following your instruction to interrupt 21 breast feeding. And point two asks you to explain what 22 that consequence might be if you don't follow the 23 instructions to interrupt breast feeding.

24 Now --

I t 25 MEMBER WAGNER: But, Larry, consequences is a v

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89 1 very strong word. And the thing is, maybe something

, _ , 2 lighter like -- and the reason for this guidance, would be

\ 3 a different interpretation. '*But?fdohis@shdsiviis?so; 4 cominous That's the problem. It's how ominous 5 consequences means. The reason or --

6 MR. CAMPER: The importance of following the 7 guidance or the rationale?

8 CHAIRMAN SIEGEL: That's better.

9 MEMBER WAGNER: Yes, that's much better.

10 MEMBER WOODBURY: Call the question, Mr.

11 Chairman.

12 MEMBER SWANSON: To me, it's incorporating the 13 word. When I give guidance to my children, I try to 14 explain the reasons why.

i 15 MEMBER WOODBURY: Call the question, Mr.

16 Chairman. l 17 CHAIRMAN SIEGEL: The motion been called. !

l 18 There were some other -- there was some other discussion. !

l l

19 But, we can either take the question or we can go through 20 the motion to answer the question call. Do other people 21 feel they need to make a comment before we proceed?

22 All right. Question has been called. So, the 23 motion was, is that we're recommending that you truncate 24 that sentence after the word breast feeding and delete the b 25 item 2.

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90 1 MEMBER BRONN: I thought the question -- I 7-~g 2 thought the recommendation that you substitute a word such

\\' '] 3 as rationale?

4 CHAIRMAN SIEGEL: No, that was not Dennis' 5 motion.

6 MR. CAMPER: Not the motion.

7 MEMBER HOODBURY: The motion is to --

8 CHAIRMAN SIEGEL: Now, we could come up with 9 an amendment or a substitute motion.

10 MEMBER BROWN: I'd vote for that one, the one 11 to change the words since consequences seems to be such a 12 sticking point and have such a negative connotation.

13 CHAIRMAN SIEGEL: So let's to try the t'

14 following just for the purposes of discussion. I guess 15 the question has been, can we table motion to call the i 16 question while we continue to discuss this? Does the 17 motioner allow that? And the committee go with that?

1 18 We're not getting too formal here.

i 19 How about the instructions shall also include, 20 (1) guidance on the interruption of breast feeding, and 21 (2), the rationale for interrupting breast feeding.

22 MEMBER NELP: Why don't you -- I'd like to 23 make a suggestion in the language. Say, assuming there 24 were no interruption of breast feeding -- I'm not sure of .

gs ]

( 25 the English of that.

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91 1 CHAIRMAN SIEGEL: That's correct. It's called

-'s 2 for.

\~~ 3 MEMBER NELP: Yes, I guess that is 4 subjunctive. Thank you, Doctor, esteemed Doctor.

5 MR. CAMPER: Esteemed Chairman. '

6 MEMBER NELP: Assuming there were no 7 interruption of breast feeding, the instructions. I would 8 say the licensee should provide guidance for the patient, 9 period. Just make it very simple.

10 CHAIRMAN SIEGEL: Well that's the original 11 motion.

12 MEMBER NELP: If there's no interruption, the 3 13 licensee should then provide appropriate guidance for the !

14 patient.

l 15 MEMBER BROWN: I think given ---just as a

... 16 practical manner, given how much this has been debated and 7 l 17 where it is in the process of becoming a final rule, that 18 this committee would have a lot better luck changing one 19 word than dropping two. And I would vote for changing the 20 word to something less objectionable.

21 ,

MEMBER STITT: I like Judith's idea. The --

22 I'm sitting here listening to the discussion and I grew up i 23 in the era of Truth or Consequences. And that tells you 24 something about why that word is such a harsh word here.

25 Because either you've got the truth or you've the l

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92 1 consequences. And I think that if we try to make a major 2 change in this, we're going to get absolutely no where.

V 3 But that's a hostile word, at least in my generation.

4 CHAIRMAN SIEGEL: We've got several different 5 approaches on it. I 6 MEMBER WAGNER: Well, what we have is we have 7 a motion and then we have motion to amend. So we have to e look at the motion to amend first and then look at the i 9 motion.

10 MEMBER NELP: Could you state the motion, 11 please?

12 CHAIRMAN SIEGEL: Well, the motion was that we 13 recommend that the final sentence of proposed (b) be V 14 truncated at breast feeding. The motion to amend was that i

15 we recommend that item 2 --

16 MEMBER NELP: The first motion eliminated item 17 2, is that correct?

18 MEMBER WAGNER: That's right.

19 CHAIRMAN SIEGEL: The first motion is to 20 el iminate item 2. The second --

21 MEMBER NELf't The second?

22 . CHAIRMAN SIEGEL: The amendment or the 23 substitute motion would be to come up with a different.

24 language for item-2. And did someone write down what I 25 said? Because I didn't.

V .

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93 l 1 MEMBER WAGNER: Information on the rationale l

,,, 2 to follow the guidance.

( j 1

G 3 MEMBER BERMAN: Wouldn't it be simple to say j h I 4 guidance on andfrationale for.the interruptyio)17 )

l 5 MEMBER BROWN: That's fine.

6 MEMBER BERMAN: That would be fine. And could 7 it guidance on and rationale for the interruptioY or 8

jscontinuat1[ofbreast feeding, based on what you had 9 said, Barry? You might want to add that.

10 MEMBER BROWN: I don't think we have too much 11 license to edit given where this is in the process.

12 MEMBER WOODBURY: We have license to advise.

13 MR. CAMPER: We certainly will take your )

14 advice.

15 MEMBER BERMAN: Interruption suggests they can 16 go back on it. Whereas if it's I-131, as Barry was saying, ,

1 17 he's want to tell them to discontinue.

18 CHAIRMAN SIEGEL: Well, that is spelled out in 19 the regulatory guide. That's spelled out in lots of ,

20 scientific documents that we would be expected to refer to 21 as practitioners.

But tell me what you just said, Dan?

22 MEMBER BERMAN: Guidance on and rationale for 23 the interruption or discontinuation.

24 MEMBER NELP: I like it.

25 MEMBER BERMAN: Of breast feeding, period.

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94 1 MEMBER NELP: I like that very much.

c 2 CHAIRMAN SIEGEL: Now --

I k 3 MEMBER WAGNER: I second that motion.

4 CHAIRMAN SIEGEL: Good. So thet really now 5 becomes the substitute motion and I guess there's an !

6 option for the --

7 MEMBER SWANSON: I will withdraw the initial 8 motion.

9 CHAIRMAN SIEGEL: Excellent.

10 MEMBER BROWN: And I withdraw the amended 11 motion. i 1

1 12 CHAIRMAN SIEGEL: Excellent. So we now have a l 13 substitute motion. And let me read it based on what I 14 think it says. The substitute motion would'be, is that 15 the ACMUI recommends that the final sentence of proposed -

16 - what is this -- 35.75(b)?

17 MS. TROTTIER: Right. Just (b) is good 18 enough.

19 CHAIRMAN SIEGEL: Be amended to read, If the ;

20 dose to a breast feeding infant or child could exceed 1 21 millisievert (0.1 rem), assuming there were no 22 interruption of hreast feeding, instructions shall also 23 include guidance on the interruption -- no, guidance on --

24 MEMBER BERMAN: And rationale for.

25 CHAIRMAN SIEGEL: Guidance and -- No, it NEAL R. GROSS COURT REPORTERS AND TRANSCRGERS 1323 RH00E ISLAND AVENUE, N W.

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95 1 should be --

2 fm MEMBER BERMAN: Guidance on and rationale for.

(

L 3 CHAIRMAN SIEGEL: And rationale for the 4

interruption or discontinuation of breast feeding, period.

5 That's the motion.

6 MEMBER BROWN: That's good.

7 MEMBER BERMAN: And you're taking out the when 8 parenthesis also.

9 CHAIRMAN SIEGEL: Is there a further 10 discussion on that motion?

11 MEMBER NELP: Has it been seconded?

12 MEMBER WOODBURY: Yes.

13 CHAIRMAN SIEGEL: It was seconded and 13 prior O

\,s 14 motions were withdrawn.

15 MEMBER NELP: Call for the question.

16 CHAIRMAN SIEGEL: All in favor?

17 (An oral vote was taken.)

18 CHAIRMAN SIEGEL: Opposed?

19 Let the record show that the -- and 1 vote 20 aye. Let the record show that the ACMUI unanimously 21 recommends that even though this package is sitting with 22 the EDO, that we go back to that language. gD 23 MS. TROTTIER: Actually, we have it. So --

24 CHAIRMAN SIEGEL: Super.

\

25 MS. TROTTIER: We will discuss this with the tb NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RMODE ISLAND AVENUE. N.W.

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l 96 1 EDO's office.

(o \

2 CHAIRMAN SIEGEL: Good. Continue.

3 MS. TROTTIER: On the next slide, then, this 4 \

is the record keeping part of the rule. And I know a lot 5 about this because I was in the EDO's office when he 6 rejected this rulemaking the first time. And it was )

l 7 because the language that was previously proposed in his i 8 mind was very confusing. It's down at the bottom and you !

\

9 can see it. He really got caught on attenuation of 10 radiation by body tissue, blah, blah, blah. His view was 11 only health physicists understand this and, anyway.

12 What we ended up with, I think, will probably l

13 be acceptable to him in that it is in more plain English.

(V) 14 So that's really what the purpose of this change was, to 15 make the record keeping requirement easily read. ,

l 16 CHAIRMAN SIEGEL: Dennis? I

{

1 17 MEMBER SWANSON: Afraid I have a comment 18 there, too. What is meant by using an activity other than {

19 the activity administered? Is this as in making a error 20 in the calculation, an error in the administration? What 4 21 is that in reference to? l 22 MR. CAMPER: It means -- it's a conservative 23 approach. We're using the original amount of activity 24 administered to the patient as opposed to any

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97 1 time. You may cortainly do that. You may certainly use

/

-x \ 2 the approach where you bring to bear biological

\\ ') 3 elimination and so forth. But if you do that, it requires 4 a record.

5 CHAIRMAN SIEGEL: Don't 1 and 3, though --

6 MEMBER SWANSON: Hand in hand.

7 CHAIRMAN SIEGEL: --

capture the same thing?

8 MS. TROTTIER: Yes, it does.

9 CHAIRMAN SIEGEL: Although they capture it in 10 a slightly different way. One -- the component in 1 11 allows for a very rapid initial elimination component that 12 quickly reduces the body burden to some relatively small

/s\ 13 numoer. And then 3 uses an effective life of the

I

\-./ 14 remainder as opposed to just the physical life.

15 Now, either one could be captured by either 1 16 or 3. In a way they're redundant. But I personally can 17 live with this. Especially if regulatory guidance 18 explains what's going on here.

19 Anybody terribly troubled by it?

20 MEMBER SWANSON: Even if you used the 21 biological half-life, how can you base it on an activity

, 22 other than that which was administered? It just doesn't 23 make any sense to me unless you're talking about errors.

24 MEMBER BERMAN: Maybe it should say using O)j

( 25 activity less than the activity administered.

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98 1 MEMBER SWANSON: No, why would you do that?

2 MEMBER BERMAN: Because what was stated about O-s 3 rapid excretion.

4 MEMBER BERMAN: I tell you, that statement 5 just doesn't make any sense.

6 MEMBER WOODBURY: The thing that disturbs me, 7 if the language is written that the committee can't 8 understand, how do you expect the licensees to understand?

9 And I'm totally confused.

10 MEMBER BROWN: Right.

11 MEMBER STITT: It reads like a 12 misadministration. You gave something that you didn't

-, 13 mean to.

s- 14 CHAIRMAN SIEGEL: Actually, why do you need 15 item 1 at all?

16 MEMBER SWANSON: Right.

17 MEMBER WOODBURY: That's right.

18 MEMBER SWANSON: Just eliminate it.

19 CHAIRMAN SIEGEL: Because I think the concept 20 that we went through when we discussed this rule at length 21 was, basically that the NCRP-37 approach says, here's a j

22 point source of I-131. Stand at it from a meter. Allow 23 for 25 percent occupancy. And here's your external 24 exposure. We've addressed issues of the leaky patient in (Oj 25 prior. discussions. And then the things you can do to NEAL R. GROSS couar aEcomas Ano ruesenieEas 1323 nH00E ISLANO AVENUE, N.W.

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99 1 modify NCRP-37 are to assume a different model for 2 elimination as opposed to no elimination.

,_ To assume that s, 3 there is attenuation of the activity by the patient and to 4 assume a different occupancy factor. Those are the three 5 variations. And I don't think you need to say that with 6 four items. One item captures it.

7 Does anybody -- staff, have a concept that's 8 different on that?

9 Stuart? I'm looking at you.

10 MR. SCHNEIDER: The reason we put that in was 11 if the number in the -- if the activity was less than what 12 was in our release table, then it was using the activity 13 administered. But if you had a value that was greater p

(_, 14 than the release table, you may have to hold the patient is until that activity was less and it no longer was the 16 activity administered.

17 CHAIRMAN SIEGEL: So you're implying that a l

18 patient would get 6.8 millicuries of I-131 and the release

]

19 table say 6.6. And you just keep him for an hour and it's 20 down to that level and then you let him go home?

21 MR. SCHNEIDER: But it's still based on --

22 CHAIRMAN SIEGEL: But your release table is 23 actually also going to include some -- substitute 24 measurements based on external dose rate as well. So the

/

( 25 licensees are going to have an out from there as well.

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100 1 MEMBER NELP: That's going to be the

--( 2 determinant, isn't it? Or either/or?

\/ 3 CHAIRMAN SIEGEL: It's still going to be a 4 little bit of either/or.

5 MR. SCHNEIDER: In the case where it's 6 either/or, then if you use the release value based on the !

7 dose rate, then you have to have the record of the survey. l 8 And that's explained in the guidance attached to that. J 9 MEMBER WAGNER: Barry, would the wording -- l 10 since what they want is the retained activity rather than 11 the administered activity, it seems to me that that's the 12 change that you need in number 1 to satisfy what they 13 want.

O

\- 14 CHAIRMAN SIEGEL: Well, it's retained --

15 MEMBER WAGNER: It's the retained activity.

16 CHAIRMAN SIEGEL: Retained when?

17 MEMBER WAGNER: Well, it doesn't matter. I 18 mean, it's retained at any point that they want to release 19 the patient. If it's based upon the retained activity at 20 the time of release rather than the administered activity.

21 MEMBER NELP: I'm confused.

22 CHAIRMAN SIEGEL: That actually is the basis 23 for releasing someone who got thyroid cancer. therapy, 24 right?

25 MEMBER WAGNER: Right.

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101 CHAIRMAN SIEGEL: You really are basing it on 2 retained activity.

3 MEMBER NELP: Rather than monitored exposure?

4 I'm confused.

5 CHAIRMAN SIEGEL: Well, it's either/or.

)

6 MEMBER WAGNER: Yes, it's either/or.

7 MEMBER NELP: It would seem to me that if 8 someone gives more activity to the patient than is in the 9 table, then they ought to go the release criteria by 10 monitoring the patient.

11 CHAIRMAN SIEGEL: Cathy?

12 MEMBER NELP: That's -- you have a choice, 13 wouldn't you?

14 MR. CAMPER: No, remember, it's purely dose 15 driven now. I 16 CHAIRMAN SIEGEL: And it's --

L7 MR. CAMPER: It's 500 millirem absolute limit 18 and you also have the 100 millirem consideration.

19 CHAIRMAN SIEGEL: Right. It's dose driven but 20 it's dose driven with the ability for licensees to refer 21 to tables if they don't want to calculate doses. And the 22 tables provide lot of conservative room --

23 MR. CAMPER: I understand. But I think Dr.

24 Nelp was referring to the current criteria where you're i

,~~ \

25 measuring a meter, 5 mr per hour the other or that NEAL R. GROSS count nEcouns ao inescamEns 1323 nHOOE 1 LAND AVENUE. N W.

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102 1 currently exists?

c 2 CHAIRMAN SIEGEL: But the table actually --

f

\s 3 the tables ar we last saw them included bo h dose rates 3 sha.~\ b c-ivity, as I recall. Gd yn i mda gd l 4 and

5 MEMBER NELP: Isn't that correct?

6 CHAIRMAN SIEGEL: And I have this in the 7 regulatory guide.

8 MR. CAMPER: The tables do that. That's 9 right.

10 MS. TROTTIER: Right. I believe they still do 11 today.

12 CHAIRMAN SIEGEL: Cathy.

13 MR. CAMPER: That's right.

(,- 14 CHAIRMAN SIEGEL: Cathy, did you want to 15 comment?

16 MS. HANEY: I was just going to say that the 17 reg guide tables, the way they're set up right now, are 18 set up as administered activity and that's why the -- one 19 of the reasons why the rule language, it was in there base 20 don administered activity. However, if you're taking into 21 account at the time of administration, then you are 22 looking at the dose that is retained in the body. So, it 23 depends upon -- both are right but it' depends which way 24 you're attacking the problem. Which way you're attacking.

25 MEMBER WAGNER: It seems to me what you're NEAL R. GROSS COURT REPORTERS AND TRANSOWSERS 1323 RHODE ISLAND AVENUE, N W.

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103 1

getting at, though, is the idea that you'd use retained

,s s 2 activity which still would be beyond what the table is.

-- 3 MS. HANEY: It is. But the values -- the 4 simple way to look up the table is to look at the 5 administered activity.

6 MEMBER WAGNER: Right. I understand. I 7 understand. And if they wanted to release him based on i 8 retained activity, they'd have to go through a calculation 9 to judge that -- to justify that.

10 MS. HANEY: Right.

11 MEMBER WAGNER: So, a solution to your problem 12 is to say, using the retained activity, not the

-s s 13 administered activity. So if in their justification they

(-- 14 used retained activity as opposed to administered 15 activity, they can justify it. 'I mean, I think that's the 16 issue that you're getting at.

17 MR. CAMPER: The problem is, if you go back 18 why was C put in at all? And if you -- for example, if 19 you read it and it said the licensee --

20 CHAIRMAN SIEGEL: You don't really want to 21 raise that question.

22 MR. CAMPER: I think I just did.

23 MEMBER WAGNER: Kick the dog again, Larry.

24 MR. CAMPER: But if you were, for example, to (D

( ) 25 say, the licensee shall maintain a record of the basis for NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE 18 LAND AVENUE, N.W.

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104 1 authorizing the release of the individual for three years fs 2 after the date of release, period, that's a problem. We i

\~ 3 felt that was a burdensome record keeping requirement 4 because it would require every release to have a record.

5 And we didn't want to do that.

6 So, what we attempted to do was to establish a 7 ' conservative criteria that if followed, and this is where 8 you get into you're treating it as a point sore, you're 9 treating at a specified distance. You're using the 10 original amount of activity administered. If you release i

)

11 considering those kinds of considerations which the tables 12 describe the amounts, then no record keeping is required.

13 But if you deviate from that, then you find yourself in (x 14 record keeping space. So it was an attempt'to reduce the 15 amount of record keeping.

16 MEMBER WAGNER: I understand that.

l' 17 MEMBER NELP: I'd like to comment.

18 Larry, you know, if I take your chest X-ray, 19 I'm obligated to keep it in my file for X number of years.

20 If I treat you as a patient, I'm obligated to put in your l l

21 medical record what I've done and that medical record is a 22 permanent file for your life. And for a number of years.

23 So, it's really not very burdensome, and I do this 24 routinely and I'm sure other people do, when I treat you,

( 25 I will say how much I gave and I can put in there released NEAL R. GROSS 1 count nEmmins AND ramseneEns 1333 nHOOE 19 LAND AVENUE, N W.

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105 1 with such and such activity, period. I mean, it's a

,-s 2 matter of current procedure.

k)s_ - 3 MR. CAMPER: But I don't think that the !

4 documentation of chest X-rays and the like have anything 5 to do with the possible dose consequence to a member of 6 the public.

7 MEMBER NELP: No, but I'm saying even now I j 8 keep this record permanently. It isn't a burden for me to 9 keep this record for three years. That was my point. I 10 keep this record permanently now.

11 MR. CAMPER: I agree. I don't think the 12 keeping of the record is the problem. I think the l

,, 13 development, the need for the development of the record is k, s 14 the problem. What we attempted to do here was to 15 establish a threshold below which you would not have to 16 develop a record using conservative practice.

17 MEMBER NELP: Even below your threshold I keep 18 a record permanently.

19 MEMBER WOODBURY: Is keeping the record 20 appropriate?

21 MR. CAMPER: 'But do you want -- You don't want 22 the NRC to impose that on all --

23 MEMBER NELP: Yes, I think that's very 24 reasonable. You know, if --

O

( 25 CHAIRMAN SIEGEL: We've had this discussion.

V)

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1 106 1 You're retro --

2 MEMBER NELP:

O Am I, really? Because this is a ks- 3 routine form of medical practice. If you come to my 4 office, I enter that visit in my medical record on a 5 permanent basis.

6 CHAIRMAN SIEGEL: I'm not sure you keep those 7 records in an NRC readily inspectable format.

8 MEMBER NELP: I think I do. I could access 9 those very readily.

10 MEMBER SWANSON: Isn't what you want to,say is 11 using an activity that results in an exposure rate of less 12 than 0.1 millirem, assuming an occupancy factor of .25?

13 Because what you're really trying to do is -- your problem O

k ,/ 14 is you're trying to allow people to release based upon 15 your guidance document but you can't refer to your 16 guidance document and regulation, right?

17 MR. CAMPER: That's right.

18 MEMBER SWANSON: So, you've got to refer back 19 to the criteria used in your guidance document as your 20 regulation. And so that's what I'm saying, using an 21 activity that results in exposure rate less than 0.1 22 millirem, assuming an occupancy factor of 0.25, which is 23 what your tables are based on. Or something in that kind l

l 24 of wording. l 1

(x) 25 MR. CAMPER: Well, you're right on the mark !

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107 1 with what the problem was, that's right, f-s 2 CHAIRMAN SIEGEL: Right. Because you can't I h

\

N '/ 3 reference the guidance in the rule.

4 MEMBER NELP: But isn't this related to 5 keeping of the record?

6 MS. TROTTIER: Well, it's which records you 7 have to keep, that's the concern. Rather than keep 8 records of every release.

9 MS. HANEY: Can I just say something?

10 CHAIRMAN SIEGEL: Yes, Cathy.

11 MS. HANEY: we felt that it was important in 12 the. case of number 3 to have it in there because of all

-- 13 the discussions that took place about having a table that

'-- 14 would allow for release by taking account bi~ological 15 considerations. And again, we were trying to keep the 16 record burden down. The required regulatory record burden 17 in the license down by making sure that that statement was 18 in there.

19 CHAIRMAN SIEGEL: I'm a slow learner here.

20 Give me one more example that focuses only on item 1. I 21 give a patient 30 millicuries of I-131, or 100 millicuries 22 of I-131. When would I release the patient using some 23 other activity? Give me an example. I'm having trouble 24 understanding an example that is not --

that's just based 25 on using a different number as opposed to using one of NEAL R. GROSS count eEronruns ANo TnaNecneEns 1333 nHOOE ISLAND AVENUE, N W.

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108 1 these other assumptions to get to the different number.

, 2 That's where I'm confused.

\

N- 3 I mean, I might say it's okay for me to 4 release patients over 150 pounds when they have 50 5 millicuries because I've considered occupancy factor. But 6 that's not using a different activity administered. I 7 might do it on the basis of biological elimination. I 8 mean, not occupancy factor, shielding. I might do it on 9 the basis of occupancy factor. But I don't understand how 10 I would ever use a different number other than the 11 starting number unless you mean what Dennis and Lou were 12 driving at which is the retained activity at the moment of

,, 13 release based on some measurement.

(

\_,/ 14 MR. CAMPER: But you see, under that scenario, 15 that wouldn't require a record.

16 MEMBER WAGNER: It would if it's still beyond 17 the tables, wouldn't it?

18 MS. TROTTIER: Right, if it's not the value on 19 the table.

20 MEMBER WAGNER: That's the point that we're 21 trying to make. And that was what I thought the isrue 22 was. If you're still beyond the table but you're still 23 justifying a higher release activity.

24 CHAIRMAN SIEGEL: But then you're going to be (O

,v) 25 doing it on one of these other factors, not juts on the NEAL R. GROSS couar apoams ANo ranNacaisens 1333 aMG*)E ISLAND AVENUE, kW.

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I l 109 i

1 fact that it's a different number.

i 2 MEMBER WAGNER: Right. But the point --

s )

N- / 3 that's exact -- Well, no. I think the --

4 MR. CAMPER: No, you are. Because the reality 5 of the matter is you could release patients with 6 substantially higher activity. And the thing that would 7 let you do that, of course, is item 3.

8 MEMBER NELP: May I ask --

9 MR. CAMPER: And in that case, you will create 10 a record because you opt to release that patient at.a much .

l 11 higher activity level.

12 MEMBER WAGNER: Well, that's only if you want 13 to follow the tables. But my point is, is that if you

-[

\~ / 14 don't to -- if you still want to release at a higher i

15 activity beyond what the tables'are, then you would still j 16 have to justify it on the basis of the other activity, 17 also.

18 MR. CAMPER: I understand. But the table, the 19 one basic table is about physical decay.

20 MEMBER WAGNER: I understand what you're 21 saying.

All right. Yes. I agree. I agree. You can 22 eliminate 1 and it won't change anything.

23 MEMBER NELP: May I ask a question again?

24 CHAIRMAN SIEGEL: Sure.

I fp 25 MEMBER NELP: If I release a patient with some NEAL R. GROSS COURT REPORTERS AND 78%NSONSERS 1333 MMODE ISLAND AVENUE. N W.

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l 110 1 of these exceptions based on my own judgment, I'm going to 1

2 make a record of it. If I release a patient according to

(\

(_-) 3 the guidelines without any exceptions, I'm going to keep a 4 record of it.

5 CEAIRMAN SIEGEL: That's your choice.

6 MR. CAMPER: Not for us you're not.

7 MEMBER NELP: No, but in the practice --

8 CHAIRMAN SIEGEL: It's no longer an NRC 9 required record.

10 MEMBER NELP: But in the practice of medicine, 11 because of my role as a physician, my medical malpractice 12 insurance, my ability to bill appropriately, and my 13 professional career, I am going to keep a record of it.

O

\s ,, 14 CHAIRMAN SIEGEL: But I'm just telling you ,

15 that if you send people home who got 5 millicurie imaging 16 doses of I-131, assuming they're not breast feeding, you 17 don't have to put anything down on paper for anyone --

18 MEMBER NELP: Yes I do. Yes, I do.

19 CHAIRMAN SIEGEL: NRC requirements.

20 MEMBER NELP: That's exactly correct.

21 CHAIRMAN SIEGEL: You can make whatever record 22 you choose to based on the way you practice medicine.

23 MEMBER NELP: If I'm in the practice --

24 anybody in the practice of medicine --

I 25 CHAIRMAN SIEGEL: But NRC won't --

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111 1 MR. CAMPER: With the exception of the patient 2 dose record. We do have a requirement.

3 CHAIRMAN SIEGEL: I understand.

4 MEMBER NELP: Let me complete this, Barry.

5 CHAIRMAN SIEGEL: Please.

6 MEMBER NELP: If you kept a record on 7 everything, it wouldn't be a burden to anyone because the 8 record exists. You see? The record exists. There's no 9 way that you're going to treat a patient without a record.

10 CHAIRMAN SIEGEL: We need to have a chat about 11 deregulation.

12 MEMBER NELP: I underetand.

13 CHAIRMAN SIEGEL: And about getting the

( 14 government out of our face and not about giving them more 15 to do.

16 MEMBER NELP: Thank you. I just wanted to be 17 sure that you understood my opinion.

18 CHAIRMAN SIEGEL: I guess.

19 Do we want to recommend that 1 disappear 20 because it seems like it's irrelevant?

21 MEMBER WAGNER: I second that motion.

22 CHAIRMAN SIEGEL: I didn't make it but I guess 23 I did. Do you guys have a strong argument why it has to 24 be in there? Please explain it to me.

(O L'; 25 MS. TROTTIER: See, I'm staying out of this NEAL R. GROSS COURT REPORTER $ AND TRANSCReERS 1333 RMODE 18 LAND AVENUE, N W.

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112 1

fight because I recommended about one or two things. And 2 so --

3 MEMBER NELP: It's totally redundant.

4 MR. CAMPER: In the side bar, I was just 5 trying to understand if we pulled out that element within 6 the tables, what would that do to the entire table?

7 CHAIRMAN SIEGEL: Not much. But the tables 8 are based on the assumptions that with a given 9 administered activity, that the dose will be either less 10 than 100 or less than 500 with an occupancy factor.of .25 11 at a meter with no biological elimination and with no 12 shielding.

13 MR. CAMPER: That's correct.

n(/ 14 CHAIRMAN SIEGEL: And consequently, 1 is 15 irrelevant, I think. I don't want to -- if you've got a 16 carefully articulated reason for 1 being in there, I want 17 to hear it before we vote on this motion. Because I don't 18 want to mess something up that you've really thought 19 through very carefully. But I'm happy to destroy 20 something if you don't got a good reason for it.

21 MS. TROTTIER: I'm going to be bold and say I 22 don't think we have a really strong reason.

23 CRAIRMAN SIEGEL: In that case, shall we call 24 the question?

f~h 25 MEMBER WOODGURY: Call the question.

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I l f 113 1 CHAIRMAN SIEGEL: All in favor of the

,_ 2

(

recommendation from the ACMUI that item 1 be eliminated in )

'D 3 paragraph C --

\

4 MR. SCHNEIDER: One second, Barry. When this 5 was out in July, there was an instance where it came 6 about, which I can't remember now, where the lack of this 7 phrase was very important that it be there. And I just 8 can't remember right now that specific example.

9 MR. CAMPER: Well, it becomes the basis for 10 the following elements. You have to assume some activity 11 to begin with.

12 MEMBER WAGNER: How can you administer an 13 activity that's not administered? !

O !

14 MEMBER SWANSON: Exactly. Unless it's a 15 misadministration.

16 MR. CAMPER: But that wouldn't call for the 17 elimination of 1 entirely.

18 MEMBER WAGNER: Using an activity other than 19 the activity administered.

20 MR. CAMPER: Yes, but how are you going to 21 address the point? You must have some basis of activity 22 to begin with. l 23 MEMBER WAGNER: Right. ,

i 24 MEMBER BROWN: It's activity administered.

25 MR. CAMPER: Sorry. Say that again.

v ,

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114 1

CHAIRMAN SIEGEL: A zero has got to be the 2 starting point.

(

Differential equation we're going to

? solve here. I mean, I could be giving people 100 4

millicuries and let's just say, what I'm going to do is 5 just say I gave him one. Let's just do that. That's 6

using an activity other than the activity administered.

7 That's willfully falsifying the records. I don't get it.

8 MEMBE- NELP: But you have to keep that 9 falsified record for three years.

10 MEMBER WAGNER: Could you possible have a 11 situation where you administer an activity and for some L2 reason it doesn't get into the patient? It falls on top 13 of the patient or something?

14 MR. CAMPER: It triggers the creation of the 15 record.

16 CHAIRMAN SIEGEL: This is goofy.

17 MEMBER WOODBURY: It doesn't make any sense, 18 Larry.

19 CHAIRMAN SIEGEL: What triggers the record?

20 MR. CAMPER: Using some number other than that 21 amount of activity which was actually administered.

22 CRAIRMAN SIEGEL: No. But the only basis for 23 using a number other than the number administered is 24 because you did calculations related to 2, 3, or 4.

25 MR. CAMPER:

C Right-NEAL R. GROSS coum mecens ano rameeneau inns moos eumo avenue. = w.

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I 115 1 CHAIRMAN SIEGEL: Because you can't say, well, 7 2 i really gave this patient 100 millicuries but let's just

(

3 say we only gave him 10 anc we'll release him based on l 4 that. You can't say that. What you can say is, we gave '

l 5 them 100. This patient weighs 600 pounds. He attenuates !

6 a lot. He lives alone in the mountains and we're going to 7 let him go home. Okay? Not because we didn't really give 8 him 100. Because we gave him 100, 9 I think we should call the question to i 10 eliminate 1.

11 MEMBER WOODBURY: Call the question.

12 s yo 60 - i (Whereupon, an oral vote was taken.) I /

@C@h W Gs 13 MEMBER BROWN: I'd like to abstain since I U 14 don't have the specia.1 knowledge to judge this, i

15 CHAIRMAN SIEGEL: Le't the record show that i

16 vi',h the one abstention, that we unanimously recommend -- '

17 MEMBER NELP: The only knowledgeable person !

l 18 abstains.

19 CHAIRMAN SIEGEL: You want to try (d)? !

l 20 MS. TROTTIEI;: Yes, let's try (d). I really 21 think (d) is probably pretty easy.

22 Yes, go ahead, Torre.

23 CHAIRMAN SIEGEL: Don't you dare say that.

I 24 MS. TAYLOR: I need to say that everyone ,

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116 1

for the tranocript so we know who's speaking.

m 2 MS. TROTTIER: Under (d), which is the last 3

slide on this rulemaking, this is simply the addition that 4

addresses the instructions for the breast feeding woman.

5 And that it's to retain the record for three years.

6 Previously we didn't have that provision in there at all 7 because it wasn't in the previously proposed rule version 8 you saw.

9 MEMBER SWANSON: I need to ask a question 10 about that.

11 MS. TROTTIER: Sure.

12 MEMBER SWANSON: Excuse me. You've got 13 providing instructions if the exposure could exceed .1 rem

/^

14 but your requirement for the written documentation is at 15 .5 rem. Do you really mean that?

16 CHAIRMAN SIEGEL: Yes.

1 ~7 ,

MS. TROTTIER: Yes, they say yes.

18 MEMBER SWANSON: So, you're saying --

19 CHAIRMAN SIEGEL: Breast feeding.

20 CHAIRMAN SIEGEL: Dennis, here's the --

21 MEMBER SWANSON: Let me just understand this 22 as a licensee. I give instructions at the .1 rem level 23 but you don't require that I have to document it unless 24 it's above .5 rem?

25 CHAIRMAN SIEGEL: Right. And from an NEAL R. GROSS ;

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117 1 inspection point of view, what that means, I'm hoping, is 2 that the inspector will come in and say what do you tell 3 breast feeding women who are having thyroid scans with 4 technetium pertechnetate. They might ask the technologist 5 or they might ask the radiologist, or the nuclear medicine 6 physician, or look through the brochure that's handed out. 1 7 .On the other hand, they might say have you treated any 8 patients with I-131 for thyroid cancer who were breast 9 feeding, or for hyperthyroidism in the last year. And 10 then they'll want to see the actual record that says the 11 patient was instructed that it is necessary for her to 12 discontinue breast feeding. And that's in the chart. So" 13 that's the difference.

( 14 MEMBER BERMAN: But shouldn't th'at then say, 15 in line 2, instructions regarding interruption or 16 discontinuation rather than just instructions?

17 Instructions were provided to breast feeding women.

18 CHAIRMAN SIEGEL: That instructions were 19 provided.

20 MEMBER BERMAN: It's instructions regarding 21 discontinuation of breast feeding.

22 CHAIRMAN SIEGEL: Well, it's discontinuation 23 or interruption.

24 MEMBER BERMAN: Or interruption, that's right.

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118 1 of --

2 MEMBER NELP: You can maintain --

( 7s) l \- / 3 MEMBER BERMAN:

4 I'm saying you should insert '

4 the words instructions regarding interruption or ;

5 discontinuation of breast feeding.

6 ' CHAIRMAN SIEGEL: That would make it clearer. j 7 Cathy, you had a comment on that?

8 MS. HANEY: I just wanted -- this is Cathy 9 Haney. I just wanted to say at least preliminary 10 inspection guidance, what we plan on saying is, having the 11 inspector look at were instructions given, yes or no. Our 12 intent at this point is not to have the inspectors looking 13 at the instructions. ,

/'

I ks _,)) 14 MEMBER NELP.: That's reasonable. l l

15 MR. CAMPER: Amen.

16 CHAIRMAN SIEGEL: Doctor Berman has suggested, l 17 though, that clarification might require adding the 18 following phrase, if I captured it. The licensee shall 19 maintain a record for three years after the date of 20 release that instructions regarding interruption or 21 discontinuation of breast feeding were provided to a 22 breast feeding woman if the radiation dose to the infant 23 of child from continued breast feeding -- that's getting 24 to be a pretty legalistic phrase here -- could result in a g ) 25 total effective dose equivalent exceeding 5 millisieverts.

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119 1

And I think that clarification doesn't hurt. I think it t j

'[

V

\

2 helps.

k 3 So, we could entertain that as a motion, too?

4 MEMBER NELP: But haven't you already required l 5 those instructions to be given about breast feeding and 6 this is specifically -- It's already gone through that i 7 scenario.

8 CHAIRMAN SIEGEL: I understand. This is just ;

I 9 a different part of the rule and it's just to make it l

10 imminently clear.

11 MEMBER BERMAN: It's simply a clarification.

+

12 CHAIRMAN SIEGEL: It's simply clarification.

13 I don't think it hurts at all. It's not redundant in this I i

\. _ ) 14 case.

15 Can we have a motion to make that a change?

16 MEMBER SWANSON: So nioved.~ OIlo n ' O 17 CHAIRMAN SIEGEL: Second?

0 u

18 MEMBER BROWN: Second.

bIDhk@

gg g ]

19 CHAIRMAN SIEGEL: Further discussion T) [Q ,

20 MEMBER BERMAN: Question.

21 (Whereupon, an oral vote was taken.)

22 MEMBER SWANSON: Mr. Chairman, can I make one 23 comment on this subject? And item of concern that I think 24 this committee needs to look at. There's still a fair

( 25 amount of concern in the nuclear medicine community that NEAL R. GROSS l COURT REPORTERS AND TRANSCNSERS 1333 RHODE ISLAND AVENUE. N W.

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120 1

the new Part 19 and 20 regulations that define training 2

7-~ requirements for the general public and for occupational

\m- 3 workers may be inferred to mean that patients exposed, let 4 me go on, to patients released -- or, excuse me. Family 5 members exposed to the patients released may have to 6 receive instruction. There's still some concern on that.

7 I-think that what I would like to recommend is 8 that how that is going to be addressed in Part 19 and 20 9 be brought specifically back for discussion at this 10 committee at the next meeting.

11 CHAIRMAN SIEGEL: You're referring to 201301, 12 Dennis?

13 MEMBER SWANSON: Yes.

/-, \

%_/

I 14 CHAIRMAN SIEGEL: Those limits for individual 15 members of the public?

16 MS. TROTTIER: Part 19 applies to workers' 17 instruction, it's not for the public.

18 MR. CAMPER: That's correct.

19 MEMBER SWANSON: The problem is it says 20 " Occupational dose does not include dose received from 21 background radiation as a patient from medical practices 22 from voluntary participation in medical research programa 23 or as a member of the public.

l 24 CHAIRMAN SIEGEL: Correct.

/g l

j 25 MEMBER SWANSON: It doesn't say or from a NEAL R. GROSS COURT REPOMERS AND TRANSCNSEM 1383 RN00E ISLAND AVENUE. N W.

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121 1 patient, okcy.

2 CRAIRMAN SIEGEL: But occupational dose, it O.

x- / 3 does in fact include the dose from a patient.

4 MEMBER SWAN 3ON: Absolutely.

)

5 CHAIRMAN SIEGEL: Yes.

6 MR. CAMPER: Every day.

7 CHAIRMAN SIEGEL: But remember occupational 8 dose isn't at 100 mili-rems. Occupational dose is cut at 9 5 rams, right? So the fact that I work around patients 10 who are treated with 100 millicurie doses of I-131 is very 11 much relevant to my occupational dose, and my occupational 12 dose isn't limited at 100 mili-rems per year and, )

fs 13 therefore, I don't need an exemption to get it up to 500

/\

k/s 14 mili-rems per year because because it's already 5 rems per j 15 year. fortunately I always get minimal, but that's where 16 it is. Are you with me? So occupational dose and public 17 dose don't mix in this scenario.

l 18 There has been some concern expressed that 19 public dose was going to be tricked by this release stuff, i 20 but I've been assured in discussions that I've had with ,

21 Mr. Camper and others that 35.75 will rule the day on 22 this. And much as we've seen in other discussions were 35 23 provides more specific information that applies to a 24 medical situation than the generic information in 20, then (v.

25 35 wins. That's been the general ruling made by the i NEAL R. GROSS court REPORTEM AND TRANSCRISERS 1333 RHOOE ISLAND AVENUE, N W.

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122 1 Commission on a couple of these questions.

2 MEMBER SWANSON: And I agree with you and I am l

\-- 3 aware of.that from sitting on this committee, but I can 4 tell you the way the regulations are currently written it 5 remains a concern in the nuclear medicine community.

6 MR. CAMPER: Well, you have two things to bear .

{

7 in mind. If you go back to the wrong patient rule, l 8 20.1002, "The scope," was modified so that it now reads 9 "The limits in this part do not apply to dosage due to 10 background radiation, due to any medical administration 11 the individual has received."

12 The patient release rule further goes on to I

13 clarify "Or doses from an individual who has been O

\s_) 14 administering material."

i 15 MEMBER SWANSON: Right, but will there be l 16 language in Part 20 to say that the patient release rule 17 takes preference over the Part 20, Part 19 and Part 20 in 18 a similar vein?

19 MR. CAMPER: Well, we do have some language.

20 Where is the language that clarifies that the more 21 specific part applies?

22 MS. TROTTIER: Are you talking about in 23 patient release, Larry?

24 MR. CAMPER: Yes.

Oj MS. TROTTIER:

( 25 I don't have the rule in front NEAL R. GROSS COURT MPORTERS AND TRANSCRISERS 1333 RMODE ISLAND AVENUE. N W.

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123 1

of me, but there is no training requiremant in Part 20 for i

2 members of the public.

{

s) 3 CHAIRMAN SIEGEL: How could you train the 4 general public? You can interpret that question on many f S levels.

6 MR. CAMPER: First of all, Dennis, let me, 7 that information that was published in early '94 in which 8 the commission was explaining that. The more specific i

j 9 part, in this case Part 35, ruled more than the general !

10 requirements, Part 20. Subsequent to that, in the wreng 11 patient rule under the language in 20.1002 "The scope,"

l 12 that has been further clarified that it does not apply to ;

l .

13 any exposure that the individual has received as a result 14 of a medical administration.

15 In the language in the patient release rule, 16 and I don't have that in front of me, it goes on to 17 further indicate that it's also exposure to members of the 18 public from an individual undergoing a medical procedure.

19 So we have already been on record as saying that the more 20 specific regulation applies, and we have further gone on 21 to clarify even the scope of Part 20 in each of the two 22 rulemakings.

l 23 But then the occupational worker part of it 24 doesn't apply to members of the public. It only applies

) 25 to occupational workers.

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124 1

MEMBER SWANSON: I don't have a problem with I -

2 anything you're saying --

\s- 3 MR. CAMPER: Okay.

4 MEMBER SWANSON: -- to this committee. I 5 understand your intent.

6 MR. CAMPER: Okay.

7 CHAIRMAN SIEGEL: I am concerned again that 8

the regulations in Part 19 and 20 have been interpreted by.

9 the members of the nuclear medicine community, and more l 10 than one is saying that it could mean that patients -- l 11 excuse me, family members of patients receiving 12 radioactive materials would be required to have training, p_ 13 okay. And for a couple of reasons, number one, they kind

/ \

k) s 14 of fall out in between, okay. Public dose means the dose 15 received by a member of the public from exposure to 16 radiation and/or radioactive material released by a 17 licensee, okay.

18 So basically I'm a licensee, I release a 19 patient, okay, so it falls into that criteria. It says it 20 does not include occupational dose or doses received from 21 background radiata on as a patient from medical practice.

22 It doesn't say "from a patient from medical practices", it 23 cays "as a patient" or from voluntary participation in 24 medical research programs.

25

(/O)

All I'm saying is where is the specific NEAL R. GFH3SS COURT MPORTEM AND TIuMSCRISERS 1333 RMODE ISLAND AVENUE, N W.

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i 125 1 langunga whore Part 35 release criteria will take 7-s 2 preference over Part 19 and 20 stat'ements, that's all I'm b 3 saying. '

4 MS. HOLAHAN: Dr. Siegel?

5 CHAIRMAN SIEGEL: Yes, Cathy or Trish?

6 MS. HOLAHAN: Okay, Trish Holahan. I just 7 wanted to say that as part of this rule package there are 8 changes to Part 20. One of the changes is to the 9 definition of public dose to exclude doses received from 10 patients released in accordance with 35.75. Also there l

11 .are similar changes to 20.1301 in terms of the public dose !

l 12 limit.

13 MEMBER SWANSON: Thank you. And I think those f-~x l i

m, 14 need to be brought back out again.

15 MS. HOLAHAN: And they are in the rule 16 package. l 17 CHAIRMAN SIEGEL: Okay, good.

18 MEMBER WAGNER: May I make one comment please? ;

19 CHAIRMAN SIEGEL: Sure.

20 MEMBER WAGNER: On the pamphlet that was 21 passed out, the regulatory guide 8.39, in your tables i

22 please make sure you distinguish appropriately between 23 capital M's and small m's. We don't want people getting 24 megacuries of activity.

r

( )j 25 MS. TROTTIER: Before you say anytning further i NEAL R. GROSS coum nanomias um rau.Sc= Seas 1383 AHODE ISLMdC AVENUE, N W.

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126 1 about tha regulatory guide, I just want to make one 2 important point.

7 -- I'm giving you copies of the regulatory 3 guide. I will put that in the public document room for 4 individuals who are in the room and would like to get 5 copies of it. It is a very rough draft. It has not been 6 approved by anybody, so therefore you can look at it, you 7 know, taking it into account, it's status. Hopefully it 8 will be soon out for publication, for comment. I don't 9 anticipate this process taking a long time, but I don't 10 believe it will go within the next couple months. So, you 11 know, certainly your views are welcome, but as I said, you 12 know, remember this is a very rough draft.

13 CHAIRMAN SIEGEL: And I've been kind of

-- 14 pushing hard over the last month or two to see if we were 15

~

going to get this draft regulatory guide before the j 16 meeting so we could review it. We obviously haven't. The 17 concern I've had is that when we discuss this rule the 18 first time we really started seeing some real language, 19 much of our concern related to the content of the draft 20 regulatory guide. And so my question to you is, how do .

21 you wish to hear back from ACMUI about what's in here 22 given that no realistic meeting time will allow us to 23 discuss it at a meeting?

24 MS. TROTTIER: Because I'm putting it in the (h

[

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127 1 on it from anyona.

,q 2 CHAIRMAN SIEGEL: Okay.

l \

t /

N' 3 MS. TROTTIER: And, you know, as I'm trying to 4 say, I'm giving it a couple of months because I don't 5 anticipate it getting out of here within the next two 6 months, but, you know, six months is probably too long to 7 get back to us.

8 CHAIRMAN SIEGEL: In the event that members of 9 this committee worked hard tonight and we thought that 10 there were some issues that needed to be raised while 11 we're here, I'd guess I'd reserve the right, unless you 12 tell me I can't, that we might try to address some of this 7- s 13 tomorrow.

i- 14 MR. CAMPER: I think that's fine, if the 15 agenda allows it.

16 CHAIRMAN SIEGEL: Okay. So I would encourage 17 all of you to try to look at this --

18 MR. CAMPER: Let me ask you another question, 19 Barry.

20 CHAIRMAN SIEGEL: Sure.

21 ,

MR. CAMPER: As Cheryl pointed out, these 22 guides will be published for public comment. And what's 23 the time line on this particular guidance document for 24 public comment?

p s h h

( ) 25 MS. TROTTIER: You mean how long?

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128 1 MR. CAMPER: Yes.

em 2 MS. TROTTIER: We don't have one set. I mean 3 I don't believe there is, ye w, an urgency to have a 4 short review period.

5 MR. CAMPER: You might want to ponder, Barry, 6 whether or not a subcommittee may --

7 CHAIRMAN SIEGEL: Why don't I just move ~in?

8 MR. CAMPER: -- public comment period. I only 9 offer that as something to think about, and we would I

(

10 entertain that. "

11 CHAIRMAN SIEGEL: Yes, great. It's not all 12 that entertaining, but maybe.

p 13 Okay, continue.

(

14 MS. TROTTIER: Okay, now I did, you know, 15 obviously tell a fib, that I could be done here in an ;

1 16 hour, so we'll move on.

17 I believe the next topic will be fairly simple 18 because I really don't have much to tell you. This is the 19 guidance for the radiopharmacy rule. You reviewed it the 20 last time you met, I believe, and we have taken some i

21 additional comments and we expect the guides to be issued 22 for public comment shortly. The public comment period 23 will ba 180 days, so there is going to be a long period of 24 time, but I think it's pretty close now, so.

O I 25 CHAIRMAN SIEGEL: Yes, Dennis?

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1 129 1 MEMBER SWANSON: Question?

,_ 2 CRAImdW SIEGEL: Yes, Dennis. '

(

k-s 3 MEMBER SWANSON: Was it still your intention 4

to conduct a workshop on that in the involved part?

5 MR. CAMPER: Yes, I wanted to make two 6 comments. I wanted to, as Cheryl pointed out, this 7 committee has seen this before. And also there has been a 8 great deal of effort exhorted by Dennis Swanson and Marc 9 Ratman. I think Marc is still here. Dr. Ratman is one of j 10 -- is our ex-medical visiting fellow. And a great deal of 1

11 work has gone into these guidance documents. Also Dr.

12 Pollycova too has made a significant contribution. I want 13 to thank them for that.

(3 s ,/ 14 But, yes, we do intend, we have previously 15 committed on the record that we would have a workshop, a 16 one-day workshop, with representatives of the 17 radiopharmaceutical industry, and we had hoped to do that 18 before the guidance documents were published. That hasn't 19 happened or won't happen for a number of different 20 reasons. But, yes, during the public comment period there )

21 will be a one-day workshop here, and we'll allow 22 representatives of the industry to take a look at the 23 guidance as well, absolutely. i 24 MEMBER SWANSON: Thank you.

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1 we had on the agenda was the pregnancy and breastfeeding l

(~'N 2 rule. That's currently on hold for a number of reasons. \

I (s-) 3 We're still waiting for information from our contractors

{

4 as well as the decision to just hold off until we get the 5 National Academy of Sciences study completed. But I 6 believe the staff had actually come up with some 7 questions.

8 In an effort to move this along, we could 9 defer these l'eally. I mean I don't believe there is an 10 urgency, Dr. Siegel, if you would like to defer them. I 11 think we had them on the agenda, but we're really not 12 going to make any decisions on this topic until the next 1

13 meeting.

In)

'N ,/ 14 CHAIRMAN SIEGEL: This is not a five minute 15 discussion.

I 16 MS. TROTTIER: Yes, I, realize that. '

17 CHAIRMAN SIEGEL: And I think when we do it, 18 we ought to do it in a fashion to revisit the stuff we 19 talked about three years ago --

20 MS. TROTTIER: Yes.

l 21 CHAIRMAN SIEGEL: -- and do it so we can 22 really analyze it in depth and not in two minutes.

23 MS. TROTTIER: I would prefer to do that. So 24 unless you object, I'll not --

()\

u 25 CHAIRMAN SIEGEL:

NEAL R. GROSS And I'm saying not just in -

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131 1 the interest of our schedule, but in the fact that this 2 really needs to be aired with more than a little bit of 3 time.

4 MS. TROTTIER: Yes.

5 CHAIRMAN SIEGEL: Any disagreement? Okay.

6 MS. TROTTIER: Okay. Well, then I will jump 7 to the petition and --

8 CHAIRMAN SIEGEL: Excuse me, Cheryl.

9 MS. TROTTIER: Yes, sure.

10 CHAIRMAN SIEGEL: We theoretically have,about 11 an hour and a half's worth of work to do and it's now 12 11:30, before we break for lunch. We don't know how long 13 this petition will take. Larry was just looking to see if 14 there is any logical way to juggle this. I would propose 15 that if we can get through all of it in an hour, that we 16 work through until 12:30 and then not break for lunch 17 until then. But does anybody feel hypoglycemic?

18 MAN: I've gotten pretty --

, 19 CHAIRMAN SIEGEL: You can leave.

20 MR. CAMPER: Another alternative would be to 21 do the intervascular brachytherapy issues now and break at 22 lunch.

23 MS. TROTTIER: We could go back and do it the 24 way it originally was on the calendar, because --

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E 132l 1 cover tha intravaccular.

l 2 MS. TROTTIER: In 30 minutes.

i ,r ] .

3 CHAIRMAN SIEGEL: The only question I would 4 ask is if there are representatives here from Tri-Med who 5 would feel betrayed if they to stay until after lunch?

6 The real question is whether you're going to miss your 7 airplanes if we do it right after lunch?

8 MAN: Yes.

9 CHAIRMAN SIEGEL: Then why don't we take 10 Larry's suggestion --

11 MS. TROTTIER: That's fine, i 12 CHAIRMAN SIEGEL: -- delay it until after O.

13 lunch and let's go on with intravascular brachytherapy.

'(j\

I 14 MS. TROTTIER: Okay.

15 CHAIRMAN SIEGEL: We haven't even begun to 16 consider the turf issues on this one yet.

17 MS. TROTTIER: Thank you very much.

18 CHAIRMAN SIEGEL: Thanks, Cheryl. l 19 I announced earlier that we were going to get 20 oral comments from ASTRO and I'm told we only have written 21 comments from ASTRO, and you have copies of them before 22 you.

23 Jim, go ahead.

24 MR. SMITH: Yes, the topic that we want to i(D -

25 discuss today is something we see is coming on the horizon l4 l _

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i f 133 1 and it's probably a very large application of 1

2 brachytherapy and a non-cancer modality.

i s_s! 3 We first got' wind of this back in May when 4 Trish came back from, what was it, the International 5 Conference on Brachytherapy, down in Palm Beach. And we 6 first heard that there was the proposed treatment of 7 brachytherapy for restenosis.

8 From some of the information we received from 9 -one of the local vendors of sources it appears that in 40 10 to 60 percent of patients who ur.dergo balloon angioplasty, 11 that they're liable to -- they're possibly going to have 12 restenosis later in the future. Various medications and 13 mechanical methods have been used in an effort to prevent O 14 restenosis with very disappointing results. There is 15 evidence that a proliferation of smooth muscle cells 16 causes restenosis in response to stretch and stimulation 17 by a variety of growth factors. And this comes into play 18 also because they are now using stents and they're finding 19 that the stent itself also causes restenosis.

2.0 It's been hypothesized that local radiations !

21 to the angioplasty treatment site may result in a 22 reduction of the incidents of restenosis due to the growth 23 and inhibitory effect of radiation on vascular smooth 24 muscle cells.

f-~ :

( }s 25 There have been two studies that I'm aware of.

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f 1 4

i 134 l

I 1

One is being done at Scripps Institute, and currently l

-s s 2 today they are having a conference to present some of I )

\~ / 3 l

1 their results. And there is another trial that was

{ 4 conducted in Germany, and they've had promising results.

1 I 5

Animal and human studies using these treatments in Europe l

6 have demonstrated promising results. So there is a great 7 interest.

8 Currently at the AAPM they decided to prepare 9 a task group to deal with this issue. They plan to put 2 10 out information regarding the modality in a newsletter, '

11 and they're also planning on doing a task group report on 12 the subject.

s 13 It's estimated that approximately 400,000 t \ \

\~_/ 14 patients a year will be candidates for this procedure, so 15 this can well outshine any radiation treatment or 16 brachytherapy treatment of cancer patients. With this 17 number of treatments it's anticipated that the use of 18 brachytherapy u.ay be used more by cardiologists than by 19 oncologist. I know we've always had issues of training 20 experience with cardiologists here in the nuclear medicine l 21 area, and this may be another area for the training 22 experience issue to come up again.

23 Additionally, in recent months, ever since we 24 found out about this, we've been approached by several

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135 l

l 1

permanent implants in the microcurie range, some are 2 currently using or plan to use HDR treatment for these N_/ 3 treatments.

4 The activity sources ranges from microcurie 5 for the permanent implants up to the curie range for the 6 HDR treatments. Since the goal is to deliver a dose of 7

radiation to the smooth muscle cells and vessel and to 8 limit the dose to the rest of the patient. Some 9 manufacturers are suggesting that they use a beta emitting 10 coated stent under 10CFR35400 intravascular brachytherapy 11 is not an approved use, nor is the use of this unsealed 12 source.

l l

13 Trish? I know each of you has these questior.s lg,,/ 14 in your handout, but for the benefit of the people in the 15 audience?

16 MEMBER BROWN: Is it necessary for me to know l 17 what restenosis is, or just to know it's a bad thing and l

18 you don't want it?

19 MR. SMITH: It's following balloon angioplasty 20 I believe there is a growth of cells inside the vessel 21 wall, and it basically it occludes the vessel within a few I

22 months following the treatment.

23 MEMBER BROWN: Okay. ;

l 24 CHAIRMAN SIEGEL: Buzz, please use the 1 25 microphone so people can hear you.

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136 1 MEMBER BROWN: Thank you.

7-~ 2 CHAIRMAN SIEGEL: Okay. Did you get any of (k~ )

3 that? Doctor Nelp tried to say that it was a tightening 4

up of the coronary arteries so that blood flow is impaired 5 again following angioplasty.

6 MR. SMITH: We understand that it also goes to 7 femoral arteries too because there have been some 8 peripheral treatments and they had the same results.

9 The first question we have is, should NRC 10 consider changing its training experience requirements to 11 allow cardiologists to perform these treatments? We have 1

12 discussed this matter with our office director, and his

)

,-~s 13 statements to us, although they're not written down, is i

)

~_ / 14 that regardless of who performs the treatment, they should 1

15 have the same training experience as a radiation l 16 oncologist currently required under our regulations.

17 MR. CAMPER: Yes, I was going to point that 18 out. I mean it's not so much allowing cardiologists, it's 19 that currently the training requirements in Part 35 are so 20 extensive for the use of brachytherapy that it may or may 21 not be compatible with the practicing cardiologist's 22 ability to leave their practice to go get that training.

23 You have a similar situation, although on a 24 much smaller scale, with the didactic training

( w _- ) 25 requirements in 35.920. I mean currently it's on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.

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137 1

order of three years to be able to use brachytherapy. But 2 by the same token one can envision that if this is i

x ,) 3 something that fits readily into cardiology practice there

{

4 could be an interest in cardiologists, and that might '

5 translate into an effort to reduce the number of hours.

6 MR. SMITH: Especially when you consider the

)

7 fact that there is a wide range of treatments that they 8 are planning. There is the permanent implant where you're 9 dealing with microcurie amounts of activity, so there's 10 really not a whole lot of radiation safety involved as far 11 as the occupational exposure to employees and exposure to 12 members of public. However, you're going to get the same i i

13 dose to the patient's vessel wall.

/ \

'_) 14 MEMBER BERMAN: Just a point, it's probably s'

15 not just cardiologists, it's cardiologists and 16 radiologists who are not radiation therapists because 17 these are not only for the coronary arteries, so it's a 18 broad issue.

19 CHAIRMAN SIEGEL: And vascular surgeons.

20 MEMBER BERMAN: And vascular surgeons, okay.

21 CHAIRMAN SIEGEL: It's a fairly broad rule.

22 MR. SMITH: We can leave that one up there.

23 And that's the next question here. Should 24 someone who is conducting this treatment using a permanent 7

( 25 implant have the same training experience requirements as

~

)

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138 1 somebody who is doing it with HDR? I guess it depends on

, 2 how you view the training experience requirements. Are we there looking for the safety of the patient, are we n'.so 3

4 looking for the safety of the individuals who are 5 conducting the treatments?

6 CHAIRMAN SIEGEL: This seems to me like a 7 technology eminently in need of partnership during its d formativ'e years.

9 MR. CAMPER: I want to come to that at the 10 end. I have some questions. I have a concern about l

11 supervision along the lines of what we previously i

l 12 discussed with the urologist / therapist connection for the l 13 prostate implants. You might recall we discussed that not 14 too long ago.

l 15 I can readily see where this question of l

16 adequate supervision and interfacing could be a problem 17 for these procedures.

18 Are you going to go back and revisit each 19 question?

20 MR. SMITH: Well, I was hoping we could visit 21 these questions right now, but we can present them --

22 MR. CAMPER: Because I'd like to get the 23 committee to come to some kind of --

24 MR. SMITH: Okay, all right.

25 CHAIRMAN SIEGEL: We should go back to number NEAL R. GFUDSS COURT REPORTER $ AND TRANSCRISERS 1323 RHODE 18 LAND AVENUE, N W.

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139 1 one?

,, 2 'MR. SMITH:

This is number one here.

, (V ~\

3 MS. HOLAHAN: Do you want to go back to slide 4 one?

5 MR. SMITH: No, let's just go through them 6 first and then we can go back and try to get comments.

7 MR. CAMPER: Oh , I see, okay.

8 MEMBER NELP: May I inquire again, you said 9 for an individual to be qualified to use brachytherapy 10 now, it's an approximate --

11 CHAIRMAN SIEGEL: It's three years.

12 MEMBER NELP: -- three years of appropriate 13 training.

O 14 CHAIRMAN SIEGEL: Basically a radiation 15 oncology residency. ;

i 16 MEMBER NELP: A three year residency l

17 equivalent. l l

18 MR. SMITH: And also another issue that's come .

I 19 up with this that we've never seen before, brachytherapy, i 20 I believe, is traditionally done with sealed sources.

I 21 Now, in order to use a beta emitter inside of somebody, ;

22 we've had recommendations that they have a beta emitting -

23 coated stent. Now, the problem with the stent is that 24 when it expands, part of the coating is going to break off 25 and go to the rest of the body. Now, we don't anticipate l

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14 1 that the dos s anywhere else in the body will be high as

, _ 2 where the stent is localized, but should we have some sort a

_ 3 of criteria from this administration.

4 CHAIRMAN SIEGEL: You're way ahead of the 5 curve. In fact it seems to me that you're also -- but 6 it's good to know that you're thinking of that as the 7 first thing on your plate. Where is CDRH in these 8 discussions?

9 MR. SMITH: We've had joint --

)

10 CHAIRMAN SIEGEL: Because it seems to me that 11 before any of these things are going to get used, they're l

12 going to be in the loop pretty early in the game. l i

1 l

13 MR. SMITH: -- I think I can say the l l 14 following, and if I don't say it, if I say something that 15 is proprietary, Ralph, just jump up and scream. Ralph l 16 Shupin is in the back there. And let me see if I can 17 remember her name --

18 MS. RYAN: Tara Ryan.

19 MR. SMITH: Tara Ryan, and Graham Zuckerman 20 from CDRH are here, and we've had joint meetings with them 21 with three manufacturers. Currently I believe FDA's 22 position is that this is an intervential treatment with 23 significant risk, therefore, even though you have a broad 24 scope license and you have an IRB approve it, FDA is going

-I u

) 25 to have to approve your IRB's review of this treatment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.

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141 1 before you can proceed.

2 CHAIRMAN SIEGEL:

So these devices clearly 3

need an IDE in order to be used per FDA's viewpoint?

4 MR. SMITH: Ralph is shaking his head, so yes 5 I guess that's correct.

6 CHAIRMAN SIEGEL: I'm sorry for all the i 7 abbreviations.

8 MR. SMITH: Okay. brachytherapy CDRH was Center 9 for Devices and Radiological Health. IDE is 1

10 Investigational Device Exemption. '

11 MR. SMITH: Now, Scripps Institute has 1:2 conducted these trials. Now, I don't know whether or not O 13 they received approval from FDA, but I don't believe they k- s 14 did. Today they are doing a conference on their results.

15 It's been kind of difficult to g'et any information out of 16 them. I believe they believe their treatments are 17 proprietary right now. I don't know how much longer they 18 will be conducting their treatments though.

19 Okay, we can go to the next one.

20 MEMBER BERMAN: Do you know if they involved 21 radiation therapists or if it done by cardiologists?

22 MR. SMITH: We don't know anything about it.

23 They've pretty much kept it quiet. We've heard some 24 rumors. It's been really quiet. Although the

(_ 25 manufacturer of the sources for these treatments has NEAL R. GROSS count m a m m um ranNeaNoEm 1333 MH00E MAND AVENUE, N.W.

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142 l' promised me that after today he will give me some

. , . 2 information on the trials.

(

3 Also, this is another issue that's come up, as 4 far as FDA is concerned, intraluminal does not mean 5 intravascular. However, at least one HDR unit is approved

! 6 for intraluminal use, and that manufacturer has stated 7 that in his opinion or its opinion that intravascular 8 should be included in intraluminal. And we'd like your 9 comments on that, what do you think? I personally see 10 some differences in sticking a catheter in somebody,'s 11 heart, but I'm not a medical physician, so. I think we 12 can go on to the next question.

13 CHAIRMAN SIEGEL: It's no worse than O

k, 14 magnetically steered sources going into the brain.

15 MR. SMITH: And, again, this is sort of just a 16 catchall, are there unique radiation safety concerns 17 associated with this? If you're conducting this treatment 18 and the source should happen to break off and lodge in 19 someone's heart, you're going to have to have a team go in 20 and remove the source. And I'm not sure how complicated 21 open heart surgery is, but I imagine staring at a 10 curie 22 source would be kind of a difficult situation to deal 23 with.

24 CHAIRMAN SIEGEL: It's more complicated than g

25 lancing an abscess I can tell you, especially with a 10 NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RH00E ISLAND AVENUE, N W.

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143 f

1 curie source on board.

2 MR. SMITH: Yes. Now, I believe that everyone tO 3 got a copy of the written statement from ASTRO. And it's 4

their conclusion, I believe just from summarizing it, that 5 we shouldn't change any of our regulations, that we should 6

keep our requirements the same and view the training 7 experience requirements as the same for radiation 8 oncologist regardless of who is performing treatment.

9 And that's the last question I have. And then 10 I guess we can go back and run over each question 11 individually. i 12 MR. CAMPER: Jim, before we actually go 13 through each of the questions, I would like to afford the

[

\ \

14 opportunity for the' representatives from FDA, if you have I 15; any comments that you'd like to make about the procedure, I 16 the modality, or where you stand in your review process, 17 or anything you think might be of use to the committee, if 18 you'd like to make some comments, please feel free to do 19 so. l 20 MR. SMITH: I think earlier they called me to 21 let me know that we got in touch with them a little too 22 late and they wanted a prepared written statement and it 23 was a little late to do that. l 24 MR. CAMPER: All right, I just wanted to

( 25 afford the opportunity.

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l 1 144 1

CHAIRMAN SIEGEL: So let ask a clarification l , 2 question. Do you have any license applications?

]

\ 3 MR. SMITH: No, we don't have a license 4

application for the medical use, but we do have ongoing l 5 discussions with the device and source manufacturers to 6 I try and see what we're looking for and what FDA is looking '

7 for. Currently FDA is a the big hurdle because they've a

8 made the statement this is a significant risk device and l

l 9 treatment, so we currently don't have anything to worry 10 about. Nobody has got approval from FDA, and until.that l

11 happens, we're not going to see any treatments done at an 12 NRC licensee. '

13 CHAIRMAN SIEGEL: It would strike me, and I'm 14 curious to see, I'm told that we have a manufacturer's i

15 representative here who would like to make some comments.

16 Let me just speak for a second here and then we can 17 perhaps do that.

18 It strikes me that this is an emerging 19 technology that involves some issues that unequivocally 20 require the expertise of cardiologist and/or 21 c,ardiothorasic surgeons intervential radiologists and/or 22 vascular surgeons, people who are trained in steering 23 catheters in the vascular system and understand how to 24 treat the complications related to the presence of the

( 25 catheter, the administration of contrast agents, and NEAL R. GROSS COURT REPORTERS AND TRANSCNSERS 13E3 RHODE ISLAND AVENUE. N W.

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145 1 understand how to interpret the significance of vascular i

'(3 2 stenoses and whether and how they need to be treated.

k-s 3 That's one group, one level of expertise.

1 4 It also seems to me that there is a l

5 substantial opportunity here for problems related to 6 radiation safety, and they include both permanently l

l 7 implanted low dose rate sources and certainly include the 8 high dose rate sources that would need the expertise of a 9 team of individuals that might include physicians, l 10 radiation oncologist, but also would very likely include 11 medical physicists with expertise in brachytherapy and the l 12 rest of the team that's normally assembled in a radiation 13 oncology department.

O klm 14 And I would think that rather than us trying 15 to give glib answers to your very complex questions, that 16 urging you to do initial licenses by way of a team 17 approach as the basis, that you'll accept this going down, 18 is the right way to start to emerging technology off and 19 then let's watch it evolve.

20 I think to say right now that we should say 1

1 21 well, but cardiologists who take six months of training in 1

22 brachytherapy ought to be able to do this without the aid 23 of anyone else in his medical center. I think that would 24 be a mistake. First of all, that individual couldn't get g

) .25 that training. It's not clear where it would come from

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146 1

right now, or it might be difficult to get that training.

t

,-s, 2 And I think just as we encouraged with the prostate cancer

( )

\m_/ 3 seed implantation that this warrants a team approach to 4 medical care.

5 And in some ways, you know, there's going to 6 be a concern, everybody is concerned, you know, Medicate i

7 will only one physician for this procedure, but I think 8 having this committee and the NRC and the FDA take the 9 posture that this warrants a team approach is at least one 10 way to encourage HCFA to think that there might be the 11 need for more than one billable physician involved in this l 12 procedure. And I'd be curious to see what the rest, of you i

! 1 13 think about that.

j 14 MEMBER NELP: It isn't clear to me what )

15 sources of radioactivity or what~ amounts of radioactivity 16 are being used or proposed to be used in these --

l 17 MR. SMITH: It ranges the gambit. We have 18 beta emitters in the microcurie range for permanent 19 implants.

l l 20 MEMBER NELP: What species of nuclides?

t 1 21 MR. SMITH: Well, I don't know that I can tell 22 you. I know that there has been a publication at least on 23 F-32 coated stents. I know that there are one or two 24 other isotopes that have been I guess given to us in

( 25 confidence, I don't believe that we can release that NEAL R. GROSS count necomas aNoin4Necamens 1333 aHOOs ELAND AVENUE, N W.

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147 1 information right now in the public forum.

l 2 MEMBER NELP: Judith, are you aware of what

! 3 materials they're using and what levels of activity they 4 are using?

5 MEMBER STITT: The iridium-192, 10 curie l 6 source is one of the ones that are, what was it again, L

7 Eminent Chair, Esteemed Chair?

8 CHAIRMAN SIEGEL: Esteemed, Esteemed.

9 MEMBER STITT: Is so clever because he sent to 10 all of us who have E-mail, and those who don't have these 11 articles, which is probably everybody but me, the 12 Helicobacter pylorie group of articles as well as the HDR, s 13 and the animal research is being done with iridium-192 and i

14 the German trial that was published in the Red Journal was 15 also with the high dose rate, 10 curie source. So that's 16 a common source, it fits into the lumen.

17 Let me make some comments. I think the 18 questions that you've put together are far more detailed 19 than our knowledge, and it's a good question base to start 20 with. In my opinion number five is probably the most 21 important question of all of them. The others are 22 specific detailed questions But this procedure is a 23 unique radiation safety concern, and I don't think it 24 matters that it's treating benign disease, it's not benign C

( 25 in the sense that it's a very lethal disease. It's not a l NEAL R. GROSS covar mEpomas ANo rausc=eEas !

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neoplasia type of disease, but as we've all sat through 2

our discussions, committee meetings regarding particularly 3 the use of high dose rate sources, it requires tremendous 4 expertise, exactly as you put it, Esteemed Chair, from a 5 team of people.

6 Well, certainly the cardiologists bring things 7 that radiation oncologist bring different, and our physics 8 colleagues, without whom we could have no idea of what 9 we're doing or where we're doing it, when you look, if you 10 would just white-out vascular stenosis, it reads just like 11 a cancer article as far as the doses, the dose rates. The 12 total doses are exactly what I give for endometrial

-~

13 carcinoma. These are high doses with high risk

14 procedures, and have to be done very very carefully.

l l 15 We'll have misadministrations expediential i

16 with little numbers up in the corners that we haven't even 17 seen before without a team approach. This is not a small 18 amount of a low energy isotope that's being used for a 19 nuclear medicine study.

20 I think that maybe we're ahead of the game in f 21 the sense that in some of the other isotope technologies l

22 we, as a group of professionals looking at safety saw it 23 coming after it happened, and I think maybe we're ahead of 24 time and potentially are leaders. So I appreciate the

[

\ 25' work that you've done. I would have to be called a biased NEAL R. GROSS OOURT REPORTERS AND TRANSCRGERS 1323 RMODE ISLAND AVENUE, N W.

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149 1

observer because I'm a member of the subcommittee that put 2 together the ASTRO intravascular document.

t

\ 3 The fourth paragraph makes a statement that 4

likens it to a lot of the other collaboration that 5 radiation oncology is involved in, that is we cannot do 6 endobronchial therapy which intraluminal and intravascular 7 is a sub type of intraluminal, they're just body lumens, 8 but we could not do that procedure in radiation oncology 9 without the pulmonologist. And I think there is no reason 10 to think that this technology is not going to be evolving 11 in a direction that would be different than that.

12 MEMBER NELP: Can you tell me what dose rates 13 you're delivering, they're delivering to the --

O 14 MEMBER STITT: Dose rate?

15 MEMBER NELP: -- to the lumenal walls?

16 MEMBER STITT: 300 --

17 MEMBER NELP: Not rates, I mean total doses?

18 MEMBER STITT: Total doses, well most of the 19 articles are all in pigs. There's one in humans, but --

20 and the fractionation is variable, from a single fraction 21 to multiple fractions, but 2000 centigray to a small 22 volume. I have to go back to the old fashioned 2000 rad.

23 MEMBER NELP: That's nice, very good.

24 MEMBER STITT: Me too. When the numbers get j 25 in the decibel points and start moving I have to go back NEAL R. GROSS covar aponrEas ANo TauscanEas 1323 aMOOE ISLAND AVENUE, N W. ,

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150 1 to the olden days.

2 MR. CAMPER:

p

\

I'd like to make a comment.

V 3 MEMBER STITT: Okay.

4 MR. CAMPER: I'd like to put this entire '

5 discussion into perspective.. There is much to do in the 6 future obviously about this, and we will come back to the 7 committee from time to time with specific questions or 8 issues about this modality as it emerges. What we're 9 attempting to do in various, and if we couched it 10 adequately, and that is this is a very complex issue and 11 we will explore it specifically,.but what we're trying to 12 do in keeping with the effort over the last three or four l

! 13 s years certainly is to come to this committee earlier and l

j 14 earlier with conceptual problems, and layout at least a l

1S framework for you to begin to think about the fact that 16 we're going to visit this in more detail.

17 And one of the things that I think that we're 18 going to have to explore more clearly as we move in any 19 revision of Part 35, is this question of supervision.

20 Supervision was changed significantly in 1987 when Part 35 21 was last revised, and it's a fairly loosely worded issue 22 in the statements of consideration. And I think that 23 there are modalities and practices which have emerged or 24 are emerging where this team approach needs some

(~'\

\ ,) 25 attention. And we'll call upon you ultimately to help us

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151 1 articulate what that team approach should be like or what 2 does constitute an adequate level of supervision, so we

\s / 3 will get back to that at some point.

4 But we're just trying to say this is coming, 5 we're aware of it, and we're going to be talking with you 6 about it in more detail. But any thoughts you have at 7 this point in time about these specific questions will be 8 helpful to us at least for formulating ideas to look at 9 for the future.

10 MR. SMITH: Okay, did you want to go back over 11 the questions ont, at a time, or let's talk now?

l 12 CHAIRMAN SIEGEL: I'm going to allow this even i

13 though it was not announced. Do we have a representative l

k 14 from Nucleotron who wants to make a couple of comments, 15 and if so I'm going to let him do so? You can go to the 16 mic if you'd like to. And please announce who you are, 17 who you represent for the record, and try to keep your 18 comments down to a couple of microseconds.

19 MR. TEAG: Is that like a couple of 20 microcurie? My name is Steven Teag, I'm a representative 21 of Nucleotron Corporation. And item four of the agenda 22 discussing the definition of intraluminal to include 23 intravascular came from a proposal that we offered to FDA 24 recently.

25 I believe most of the people at the committee NEAL R. GFH3SS COURT REPORTERS AND TRANSCRGERS 1333 RHODE ISLAND AVENUE, N W.

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152 1 know who Nucleotron is and the product line that we

)

2 developed. I'm not going to flatter anybody by using 3 esteemed and distinguished to address the committee -- J l

4 MEMBER NELP: Could you please tell us who 5 Nuclectron is?

6 MR. TEAG: Okay. Nuclectron is the largest 7 manufacturer of remote afterloading brachytherapy devices.

8 We currently hold a 75 percent market share of this 9 technology, and we have been the vendor that has developed 10 all new technologies related to this specialty of uses of 11 sealed radioactive sources in treatment of diseases in 12 humans.

13 My first comment is concerning the regulatory O 14 space. And from the previous discussions we've heard this 15 morning on training and experience, and I'll start with 35 16 Part 940 describing the T&E for brachytherapy. There is 17 an exception to that in 941 for the ophthalmic use of 18 strontium 90 applicators as a source, specifically by non-19 radiation oncologist with that sub specialty. I offer 20 that since 35 is being rewritten in its entirety in the 21 next several years.

The time is right to consider more 22 medical specialty related items under training and 23 experience rather than these global, you know, 24 credentially by certain professional organizations.

( 25 My second comment is one, and I hate to say NEAL R. GROSS count nEeOmsas Ano inAmsca Eas 1333 RHODE WLAND AVENUE. N W.

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this in front of Dr. Stitt who I know well and admire {

'q( 4 2 intensely, but I am objecting to the very narrow view that 3

ASTRO has taken in their prepared document, that only 4 radiation oncologist have the T&E to use any sealed {

5 sources safely. I believe that -- I won't go any further 6 down that line right now.

j 7 The third question that I'd like to address is J

B number five on Mr. Smith's list of questions to you, was

{

1 9 the area of radiation safety. Since the Nuclear 10 Regulatory Commission, or from Mr. Quillin's standpoint, )

11 the agreement stated equivalents, authorized and licensed I

12 each device that uses radioactive materials including the l

)

13 radioactive sources themselves, this is a form where

\v/ 14 radiation safety issues regarding the technology can be 15 well and appropriately addressed in the design and testing i I

16 requirements prior to an agreement say or the NRC 17 authorizing the licensing of a device for use in humans.

18 I believe that the engineering design and the 19 testing thereof can prove the inherent radiation safety of 20 a device or of a radioactive source. Supplementing, that 21 is adequate training and experience, for the authorized i

1 22 users of this device will suffice to serve the public 23 needs for radiation safety both in the patients that are 24 treated with this technology, the staff and physicians and n

25 paramedical personnel that will be involved with this, and NEAL R. GROSS l court REPORTERS AND TRANSCRSERS 1323 RHOOE ISLAND AVENUE, N W.

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154 1 global view of radiation safety to the public as a whole.

,_ 2 Thank you very much.

3 CHAIRMAN SIEGEL: Dr. Nelp?

4 MEMBER NELP: I presume this translates into 5 the corporate entity that you represent and probably also 6 into the economic entity of the corporation. And the 7 corporate position is that other users could use the 8 device, and I presume you see this as a better economic 9 pathway or a more facile pathway for you to follow than to 10 market the device say through radiation oncologist. I'd 11 like some feeling for what the company thinks about when 12 they are marketing a device of this sort in terms of the

,_ 13 user. You want to broaden the user base, but you imply

\s - 14 that the user base will be bigger if you let more people is in rather than channeling it through the current channels.

16 Is that correct?

! 17 MR. TEAG: Currently there is no marketing la strategy that my company is proposing to use because there 19 is no approved device either through this Commission or l

20 through the Food and Drug Administration to market any l 21 device for this indication of treating vascular diseases i 22 with radiation.

23 Certainly I eche Dr. Siegel's comments that 24 this will be a multi-specialty use device in that the i n

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155 1 the periphoral area the intervential radiolocist who has

-~s 2 .the training and experience to manipulate a catheter 3 safely within the body. The application of radiation 4 within an existing catheter is currently the prowess of 5 the radiation oncologist, or other medical specialties 6 that the Commission has previously defined as suitable for 7 using certain specific isotopes and delivery systems, i.e.

t 8 the ophthalmic applicator by ophthalmologists.

l l 9 We see a public health benefit nationally to 1

10 this whole treatment of vascular disease with radiation

11 and a reduction in overall health care cost for vascular 12 disease, which we all know is escalating almost s

g 13 exponentially. And that's basically the end of my 14 prepared statement.

l l 15 MEMBER NELP: Thank you.

16 CHAIRMAN SIEGEL: Does anyone have any other 17 questions? Thank you very much.

18 MEMBER BERMAN: But related, it seems logical j 19 that if the use of a new technique for a very broadly, 1 l

l 20 very prevalent condition like restenosis becomes eomething i 21 that's out there, it will be inhibited if there is the 22 need to involve two specialists compared to involving one 23 from the growth of that technique.

24 I think that Dr. Stitt's comments are 25 appropriate. I mean we do all this discussion about the NEAL R. GROSS i coum necomuns Ano inAnseness 1333 aM00E ELAND AVENUE N W.

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use-of diagnostic radionuclides and how much training a

,__ 2 cardiologist needs,~and at the same time we tell the NRC m- 3 don't even regulate the field because nobody dies from 4 these small diagnostic doses, and that's a discussion 5 we'll have next February, but this one is larger. Now, 6 we're talking about really sizable doses that could have 7 potential major impact on the patient, and I think that it 8 is an important area for us to try to help at an early 9 stage, get involved in the early stage to define a joint 10 pathway for doing this appropriately.

11 MEMBER STITT: And the other thing that will 12 help us along the way is that we will be gaining a medical

,/

,-' 13 physicist with a brachytherapy background at some point in ks-)h 14 time. And I think the cardiologist and the radiation 15 oncologist could find some common ground. I think the 16 most important person in the whole event is the radiation 17 physicist, the medical physicist because that's the l 18 radiation safety of the staff and the patient, and having l 19 some idea of where that dose is and where that dose isn't, 20 so.

21 MEMBER BERMAN: But as that evolves over time ,

22 then it's perhaps possibis for the future, but a 23 cardiologist collaborating with a very strong radiation 24 physicist would be able to do this -- that an exemption or 25 some kind of training reduction from what an radiation NEAL R. GROSS CXXmT REPORTERS AND TRANSCRISERS 1323 RMODE ISLAND AVENUE, N W.

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l 157 l 1 oncologist goes through might be appropriate for a l

l (h 2 cardiologist if they're doing this in conjunction with the l (,) 3 appropriately trained radiation physicist.

4 MEMBER STITT: Well, again, I think we need to 5 look at the safety. Safety to me of the patient and the 6 public is where we need to start this whole procedure.

7 The bodies will come. We don't want to modify training, 8 we want to start with the overall picture.

9 CHAIRMAN SIEGEL: I've been waiting to see 10 what your comments were on this because you actuall.y have 11 two potential conflict of interest positions on this one, 12 and I'm saying this jokingly. One is you could want to 13 encourage cardiologists to be able to do this, speaking O)

(s, 14 for them, but on the other hand you should remember that 15 if this things works you're going to be doing a lot fewer 16 thallium scans to look for restenosis in patients who had 17 angioplasty three months ago, so it's going to have a big 18 impact on your business. Just remember that.

19 Now, I think the discussion focuses exactly on 20 what we were already talking about earlier this morning, 21 and it focuses on the thing I've been telling you for four 22 years, which is you need to change the paradigm. Instead ,

23 of starting with existing medical specialties and trying 24 to make the training and experience criteria more or less ;

( '

( 25 fit the models of those existing medical specialties who NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RMODE ISLAND AVENUE, N W.

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158 1 think they're doing an adequate job, each of the various

/-~s\ 2 things you should license, we should figure out what the k- l 3 training and experience really is that's necessary to do 4 that irrespective of where you come from and what your 5 other background is, and divorce the radiation safety 6 aspects of this from the medical aspects. And then it 7 will be easy.

8 Then we won't be thinking along specialty 9 lines. It is possible that, having defined those 10 requirements, that some specialties will be able to.come 11 and request deemed status and say our specialty training 12 program already routinely incorporates all of these

-s 13 elements, therefore, board certification in our specialty N- 14 should be sufficient to document that we have fulfilled 15 the training experience.

16 In the past I think this was developed based 17 on how can we make what we're going to put on paper fit 18 the existing specialties as opposed to literally starting 19 from the other end and do a ground-up approach to 20 developing training and experience criteria.

21 MR. CAMPER: I think that's true, and I think 22 as part of that deliberation when we get to it is, again I

23 as I have said before on the record, it's the concept of 24 what is an authorized user in ;o95. You know, you have 1

(m 25 using radiation and radioactive material in the course of NEAL R. GROSS COURT REPORTERS AND TRANSCR49ERS 1323 RMODE ISLAND AVENUE, N.W.

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the prac ice of medicine, that means something and it may 2 carry with it a particular level of training, but on the 3

other hand you also have radiation safety in its pure 4

sense for the objective of maintaining radiation safety, I 5 and that may carry with it some different level of 6 training or meaning.

7 And the truth of the matter is, is that is 9

what authorized users historically have been may not be 9 the same thing today or in the future, and we need to 10 explore that as part of that process.

11 MEMBER BERMAN: In terms of the precedent, the 12 comment was made that ophthalmologists are allowed to use 13 an ophthalmologic application without being radiation 14 oncologist. Could you explain why it is that that 15 particular exemption exists?

16 MR. CAMPER: Well, it's not an exemption. In 17 35.941 --

18 CHAIRMAN SIEGEL: It exists, it exists because 19 at the time this was created a substantial amount of that 20 was being done by ophthalmologists. In fact probably more 21 of it than by radiation oncologist. And the regulations 22 were designed to capture the amount of training that 23 ophthalmologists were currently getting in order to do 24 this. It was a top-down regulatory approach from existing 25 medical structure versus a bottom-up approach based on NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVENUE. N W.

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160 1 safety conoidarations.

p)

(V 2 MEMBER STITT: And if you look at the practice 3 of medicine, that is what are the safety issues and what 4 are the medical issues, the strontium applicators are sort 5 of black magic. No one can calibrate them, no one knows 6 what dose you're giving, you kind of wave them around, and 7 I'm being silly, but that's actually true, and depending 8 on if your stopwatch works or doesn't work or, you know, 9 if you whack the thing on the table, you may be exuding 10 some radiation. But the medical issues and the safety 11 issues are at absolutely opposite ends of the spectrum.

12 And we kind of laugh about the strontium 13 because it seems to show up on our agenda every time we 14 have one of these meetings and peoplo roll their eyes 15 because it really is a bit of a black magic sort of thing.

16 And I think that Dr. Siegel described it well, top-up 17 versus bottom-down type of thing. So we have two real 18 different agenda items if you're comparing the --

19 MEMBER BERMAN: But is it also true that the 20 radiation exposure potential, the potential hazard to 21 public safety or the patient safety is much less with the 22 ophthalmologic application?

23 MEMBER STITT: Yes, there's essentially no--

24 MEMBER BERMAN: -- So given that then, aside g

25 from the ophthalmologists are there any other kinds of NEAL R. GROSS count apo=rEns ue rau scamEas 1323 RHODE ISLAND AVENUE N W.

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161 1 exceptions to radiation oncologist kind of training being

/O 2 required for this kind of application on the body? I k ,)

s 3 think it would help if we can say no, there are not.

4 MEMBER STITT: Not a thing that I can think l 5 of. That's a real out --

l 6 MR. CAMPER: No, we only have the two at this 7 point. We have the 940 wh'ich is the full spectrum of 8 brachytherapy sources, which is the three years or 9 certifications and the other one, of course, is 941 which 10 is the ophthalmologic of strontium 90, but those ar.e the 11 only categories of brachytherapy therapeutic use. ,

12 MR. SMITH: But you also want to keep in mind

,-- 13 that there are other proposals beyond HDR treatment. I

- 14 mean there is the permanently implanted stents with 15 radioactive materials on it. And from a radiation safety 16 point of view, it's nowhere near HDR.

17 MR. CAMPER: Well, I think one message I'm 18 hearing here as we go through this T&E issue in the 19 future, I think we're going to be taking a long hard look 20 at each of these modalities and what is the appropriate 21 1evel of training or nature of training for each of these 22 modalities. We have quite a bit of work to do, don't we?

23 MR. SMITH: Well, I think there are other 24 people out there who believe we have a lot of work today A

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l l 162 1

for this, and there is a lot of talk about it amongst

,_ 2 other groups too.

3 MR. CAMPER:

m, Do you want to go one by one to 4 the questions.

5 CHAIRMAN SIEGEL: Dr. Wagner had a comment 6 first?

7 MEMBER WAGNER: I just want to make the 8 comment that I am fairly chagrined at the idea that item 9 number three is placed at item number three. I think item 10 number three should be way back in everybody's mind,, and 11 what we should be worried about is whether or not we've 12 got proper training for people to minimize anything that 13 may occur because ill trained people are using these 1 i

14 devices. 1 15 I think the mind set of putting number three 16 in the priority status it was given here, although these !

17 may not have any priority status, it's just an ill focused 18 idea. And that we ought to focus more on items one, two, I i

19 four and five as the prominent issues to be addressed at 20 this point. ;

21 MR. CAMPER: Lou, we agret. They're not 22 prioritized. But by the same token having said what you 23 just said, and I agree with you, I can assure you that at 24 some point discussions about misadministrations associated 25' with these kinds of problems will become an extremely NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS tats RMODE 18 LAND AVENUE. N W.

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163 1 volatile insuo. And it's good to at least at this point

, __s 2 in time plant the idea in your minds that we need to deal I i is ,/ 3 with this at some point, because nothing inflames like 4 misadministration. So this if food for thought.

5 CHAIRMAN SIEGEL: But of course the National 6 Academy of Sciences is likely to tell you to decriminalize 7

the misadministration issue and then it will be a whole 8 different approach in your mind set as well.

9 MEMBER NELP: To answer --

10 CHAIRMAN SIEGEL: Having said that, I can only 11 hope that that's what they're going to tell you.

12 MEMBER NELP: To answer your question about

_s 13 going through your questions, I as a advisor would much

\

\'

)

\ ./~ 14 prefer that you go through your questions and then answer 15 them, and I'd rather look at your solutions than your 16 questions 17 MR. SMITH: Okay.

18 MEMBER NELP: You know how your approach will 19 be, then we can construct more from that, I believe.

20 MR. SMITH: Well, basically I think the 21 gyestions are leading themselves.

22 CHAIRMAN SIEGEL: We can do the questions.

23 MR. SMITH: Okay.

24 CHAIRMAN SIEGEL: We can do it. Do you want

.) 25 to project them real quickly for the audience.

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164 1 MEMBER NELP: Thank you, Esteemed Chair.

- 2 CHAIRMAN SIEGEL: Thank you, Esteemed 3 Committee Member.

4 Should NRC alter its training and experience 5 requirements to allow cardiologists to be named as 6 authorized users for the modality? And I think the answer 7 we have essentially given at the moment is, it would be 8 premature to do so. And in the same breath we would 9 encourage that once FDA has got far enough to start 10 considering having these devices out with IDES for 11 clinical testing, that the NRC and state licensing posture 12 for the use of these devices should be based on a team 7-s 13 approach where all the kinds of expertise are in place i

A- 14 necessary to develope the technology properly. -

15 Because we're really in the evolutionary phase 16 of this approach, and I think the problema that could 17 arise, you've thought of some of them, but I'm sure we 18 haven't though of all of them, and the best way to capture 19 those problems is to make sure that people with all the 1 20 right kinds of expertise are playing the game.

21 ,

MR. SMITH: And we've tried to stay pretty 22 close with the FDA and some of the manufacturers on this 23 so that we're abreast of what's going on in the community.

24 CHAIRMAN SIEGEL: So do you all agree that 25 recommending a Part 35 change as a quick fix for this NEAL R. GROSS COURT REPORTERS AND TRANSCRGERS taas RMODE 18 LAND AVENUE, N W.

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165 1 would clearly be inappropriate?

,, 2 CHORUS: Yes.

3 CHAIRMAN SIEGEL: Okay.

4 Next, should the microcurie range permanent 5 implants require less training than the HDR treatments 6 even if each is designed to deliver a total dose of 10 to 7 20 gray to the vessel wall?

8 MEMBER NELP: I think that's a detail that I 9 would refer back to your first answer.

10 CHAIRMAN SIEGEL: But I think once we know 11 what's involved, the answer is likely to be yes. But 12 because the radiation safety issues to the team involved, 13 occupational exposure is going to be much less of a 14 problem than if a 10 curie iridium source breaks off in a 15 coronary artery.

16 MEMBER BERMAN: I'd just; like to say that I 17 think in the development of the kinds of modifications of 18 training requirements it's going to be important to have a 19 multi-specialty representation at the table and public 20 comment in the deliberations.

l 21 CHAIRMAN SIEGEL: Oh, I agree completely, Dan.

22 I mean I think, if I were the FDA and I'll 23 make.this comment for them, and I were working with the !

24 manufacturer to design the kinds of people that were going 25 to be involved with the clinical protocol, I would NEAL R. GROSS count namnan Amo nwecamens iJ3 aMODE ELAND AVENUE. N.W.

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166 1 probcbly insist that the protocol, that the people fx 2 involved have expertise in both brachytherapy and in k\- ') 3 steering catheters in coronary arteries, and that there be 4 a team approach and monitoring clinical outcomes. Okay, 5 so, yes, but premature to item two.

6' Number.three, Dr. Wagner I think has already 7 addressed how we feel about item three. You know, if FDA 8 writes the package insert that anticipates the dose to the 9 other tissues based on flaking of the seeds or migration 10 of activity then it won't be misadministration. ,

11 But I think that we really are ahead of the 12 game on worry about how you're going to define a 7s 13 misadministration on this emerging technology.

t ) \

14 MR. SMITH: We've never used an unsealed 15 source before for these treatments, so we're not really 16 sure we have a requirement that you check for leaking 17 sources, and if you have a leaking source during a 18 brachytherapy treatment, that's a misadministration. We 19 know these things are going to leak to start out with.

20 MEMBER SWANSON: Again, I think this is an 21 area where you really need to cooperate with the FDA to, 22 as they evaluate these devices, to try to make sure that l

23 that doesn't happen, okay, up front. I mean that needs to l 7, 24 be something that they're looking at as part of the device

(

\s, 25 development process.

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l l

167 1 MR. SMITH: Okay.

l 2 CHAIRMAN SIEGEL: And question four is, at

(. 3 least one'HDR unit is currently approved by FDA for 4

intraluminal brschytherapy and the manufacturers argue 5

that intraluninal includes intravascular. Should NRC 6 interpret intialuminal as including intravascular?

7 I think the implication of that question is 8 that, if you simply make that interpretation, then people l 9 can go forward and start using this clinically today with 10 no further thought. And my sense is that this committee 11 thinks that this technology needs to be evaluated.

12 MR. SMITH: Okay.

g 13 CHAIRMAN SIEGEL: Do you all agree that we

- 14 wouldn't want this turned loose in clinical, routine 15 clinical practice tomorrow simply because of 16 interpretation of a meaning of a word?

17 MEMBER STITT: That's exactly right.

18 MR. SMITH: I think FDA has made the same 19 conclusion, that it doesn't include intravascular.

20 CHAIRMAN SIEGEL: Any disagreement on that?

21 0,kay.

l 22 Question fiva, are there unique radiation l

23 safety considerations associated with this modality, for 24 example where is the most likely location within the i 25 medical institutions for such implantation?

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The second part is easy, it's going to be in e .\ 2 the cath lab or in the intervential radiology suite,

( )

w/ 3 sometimes in the operating room, but less often. It is 4 much less likely to be just down in the basement with 5 average radiation oncology departments.

6 MR. SMITH: It's still going to require 7 shielded treatment.

I 8 MEMBER STITT: Or extraordinary shielding'for 9 high dose rate sources. So again we've got a new plant 10 facilities here that most places will not have. i 11 CHAIRMAN SIEGEL: But the average HDR room i

12 isn't currently equipped for cardiac catheterization 13 either.

Um' 14 MEMBER STITT: No, our's would come close 15 because we do everything under flovro, accetera, etcetera.

16 But you're right, there's probabP, no location in 17 anybody's --

18 CHAIRMAN SIEGEL: Biplanar flovro?

19 MEMBER STITT: Yes. But that's unique, that's 20 just our place. You're right, most cardiology suites, nor 21 mpst HDR suites could do this procedure. And I think the 22 other radiation safety aspect is we all have to find a 23 friendly cardiac surgeon to agree to be the one that goes 24 swimming for that source that just left its tether.

25 CHAIRMAN SIEGEL: That's a key issue.

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169 1 MEMBER STITT: Right. And we keep bringing 2 that up at our meetings here, and it's not a small issue.

N- 3 We do have to be prepared, and I believe that's the 4 regulation that we were looking at three weeks ago, the 5 guidelines say, if you're going to submi': a license, you 6 have to show that you are prepared to deal with these 7 radiation emergencies.

8 CHAIRMAN SIEGEL: I mean here is the scenario, 9 the source just broke, the source was sitting comfortably 10 in the proximal left anterior descending coronary artery 11 where it was eradicating the area that had been .

I 12 angioplastated. The source is now sitting in the distal l

13 left anterior descending coronary artery where it har ;

14 caused an acute myocardial infarction, created ventricular is arrhythmias that have made the patient very unstable, and 16 a cardiac surgeon is asked, at risk to his own life, to go 17 in and remove the radiation source in a patient who 18 normally would not be a candidate for any form of surgery 19 because he's too unstable. I think that's a pretty 20 significant safety problem.

21 Do you agree, Dan?

22 MEMBER BERMAN: Yes. The only thing that I'm 23 still unclear about, and I need clarification maybe from 24 Judith, is the difference between the beta emitting coated k 25 stent and the high dose radiation?

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170 1 MEMBER STITT: Yes, and we're talking about a w 2 broad category. A beta emitting coated stent is totally different than radiation safety-wise and interstitial 3

4 implants where you could get the source activity wrong and 5 then totally different than a 10 curie source that's the 6 size of a grain of rice that has been known to become 7 disconnected.

8 MEMBER BERMAN: And the reason that I'm asking

) 9 is, I think from what I'm just hearing here, there's a 10 tremendous amount of -- we've focused a lot of atten, tion 2 11 on the high dose radiation rate approach. 1 1

12 MEMBER STITT: Right.

13 MEMBER BERMAN: And that has a lot of 14 implications for safety. I think the cardiology community is may actually be going more in the direction of the beta !

16 emitting stent approach. And if that's the case, 17 shouldn't we be.further discussing this question number 18 two, that if you were to ignore the high dose rate 19 approach for a second and come back to the discussion of 20 the beta emitting stent, are all of the things that we're 21 talking about in terms of hazards still relevant so that 22 this is something that needs to be put on to the back 23 burner ~until it's worked out, or are they so irrelevant it 24 becomes more like a ophthalmologic application?

25 MEMBER STITT: Well, I think that each NEAL R. GROSS COURT REPORTERS AND TRANSCMSERS 1333 MH00E WLAND AVENUE. N W.

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171 1

circumstance is unique, and there are specific relative

-s 2 hazards depending on which isotope and which technique,

\

3 and again where, to kind of restate what we've said, we're 4 at the beginning of the differing technologies, and if the 5 beta emitting stents are going to be'up for FDA review and 6 accessible to the medical community soon, that can be 7 worked on. But it still requires a collaborative input, 8 but there are some issues of radiation safety that are f 9 different as well as medical safety.

10 CHAIRMAN SIEGEL: Since you did not have E-I 11 mail at the time that I distributed this, I sent everybody '

12 on the committee who has E-mail a literature search that I

,- s 13 did on this. And I actually, and we can make copies for i

\

14 whoever wants it, I actually did not find any articles 15 that have used, in the published literature, low dose 16 stents.

I 17 MR. SMITH: I have a set of articles that was 18 given to me by a source manufacturer recently, and one of 19 those is regarding a P-32 coated stent. And I have 15 l i

20 copies, so whoever wants one can have one later, j 21 ., CHAIRMAN SIEGEL: Okay.

22 MEMBER WAGNER: Is that on animals?

23 MR. SMITH: Yes, they were doing it with pigs.

24 MEMBER WAGNER: Yes, that's why you don't see s,_m 25 it in your literature.

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172 1

CHAIRMAN SIEGEL: No, my literature includes 2 animal studies, and --

.I 7- s 3 MEMBER BERMAN: In our institution the beta 4 emitting stents are now being readied for study in humans.

5 So I believe what we're talking about is something that is 6 going to become, more likely to become, the focus.

7 CHAIRMAN SIEGEL: I actually think that when l

8 we know more about what the devices really are, we know 9 more about what the radiation safety considerations really 10 are, as well as the other safety applications, then.I 11 think the answer to question two will be yes. And we've 12 already said that it's probably going to be yes, but I 13 think we need to know a little bit more about what's going 14 on and then we can build the requirements from the bottom 15 up based on the safety requirements.

16 MR. SMITH: Well, currently all of these 17 proposals are proprietary and even though they were 18 proprietary, they didn't give us a whole lot of 19 information. I think basically they were fishing to find 20 out what might be approved and proceed from there with 21 their design. But we know that at least one manufacturer 22 is going the way of a coated permanently implanted stent.

23 And I believe there are some radiobiological basis for it 24 also, but supposedly, if they deliver the dose over a long O

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173 1 better result. But I'm not a radiobiologist, so I don't 2 really know if that's true or not.

(- 3 CHAIRMAN SIEGEL: Okay, we've answered them 4 about as well as we can.

5 Does anybody have any other comments about 6 this item?

7 MEMBER NELP:

8 MEMBER NELP: I liked your answers, they were 9 very good.

10 CHAIRMAN SIEGEL: There was consensus, right? i l

11 CHORUS: Yes.

12 CHAIRMAN SIEGEL: Just checking.

I 13 Why don't we then adjourn for lunch and we 14 should re-adjourn at 1:20.

15 (Whereupon, at 12:22 p.m., the proceedings in 16 the above-entitled matter were adjourned to reconvene this 17 same day at 1:20 p.m.)

1 18 ;

i 19 l 20 21

22 23 24

( 25 Q)

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(1:25 p.m.)

l 3 CHAIRMAN SIEGEL:

{ If the members of the 4 committee would please take their seats so we can

5 readjourn, having been caught on that word, reconvene.

6 The Chair has a request before we begin, 7 namely that you all stop referring to me as "the esteemed 8 chair." Your majesty will suffice.

9 All right. We are back on the record and we i 10 are now going to discuss the petition for rule making, exemption for commercial distribution for in vibo testing, I

11 12 excuse me.

13 MS. TROTTIER: In vivo. Okay. Actually, I is

! \- 14 don't remember the date, although I have it somewhere. It l 15 doesn't matter. We received a petition for rule making l

l 16 from Tri-Med Specialties.

17 The petition is basically requesting the 18 commission to consider one of two ways to amend our i 19 regulations, either to permit distribution under a general l

l 20 license or an exemption to the regulations to permit 21 production of capsules containing one microcurie of I

'2 carbon-14. That would be used in diagnostic testing in l

.3 vivo. ,

24 What we are currently doing, right now, is we 25 have an evaluation ongoing because we don't have -- there NEAL R. GROSS coum neomus anoimNemeEns 1M3 nM00E ISL#eD AVENUE, N.W.

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I 175 1 is no provision in our regulations that would allow this

,._ 2 request to fall under a categorical exclusion.

3 An environmental impact assessment or an 4 environmental assessment, not an EI, will have to be done.

5 That is going on -- oh no, we are about to do it.

6 We are in the process now of getting the 7 contract in place so that we will be looking at that, and 8 really what this does is it brings a question of the 9 different ways that this could be handled if a decision 10 were made to grant it. .

11 The position that the commission is in right l 12 now is that we haven't made a decision in any regard 13 either way, whether we are going to grant the petition,

(

\ 14 whether we are going to -- if we were going to grant the 15 petition, which direction we would go, and I guess one of 16 the reasons for bringing it before you today is primarily

( 17 to discuss the petition and the pros and cons associated 18 with going either way.

19 CHAIRMAN SIEGEL: But currently, if this were 20 a licensed product from the FDA and a physician wished to 21 use this product in his or her practice, eh would have to 22 be an authorized user under 35.910 in order to do so. Is 23 that right? j 24 MS. TROTTIER: I believe that is correct.

O 25 Yes.

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7 176 1 CHAIRMAN SIEGEL: It in uptake dilution and 2 excretion.

3 MR. CAMPER: And through a limited specific 4 license.

5 MS. TROTTIER: We did receive a lot of public 6 comment on the petition. The petition was noticed -- I 7 thought I had it here, but somehow in my moving papers 8 around I lost it, but anyway, the petition was noticed in 9 the Federal Register, and we received 300 comment letters.

10 The majority of those letters are supporting f

11 that petition, and as I said before, we still have our own 12 analysis to do.

(s 13 So we are at least probably three to four 14 months, minimum, away from making any decision in-house on i l

15 whether we would grant the petition or not, and again, the l 16 last slide shows you the two options that they are j 17 requesting.

18 One would be distribution under general 4 19 license, and that would fall under part 32, then, and the 20 other one then, would be -- and then it would be exempt, 21 but the other one would be to permit medical use under a 22 general license, under part 35.

23 That was previously in the regulations, and in 24 1987 when part 35 was revised, that provision was dropped.

O

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3 177 1 use. No one was using it so it was dropped for that 2 reason.

3 So then, the question now would be if we 4

decided to grant the petition, what would be the best way 5 to do it.

6 I think in your packets you probably do have a 7 discussion of the petition, and did we also include the 8 articles that -- okay, all right. So they have all of the i 9 information on the petition.

10 CHAIRMAN SIEGEL: Okay. Perhaps before,we go 11 on is someone from the company here to make a 12 presentation? Is that correct?

13 MS. TROTTIER: I understood they wanted to.

14 CHAIRMAN SIEGEL: Please use the microphone 15 and identify yourself.

16 MR. COMBS: My name is Matthew Combs. I am j 17 with Tri-Med Specialties, and we have given you two l

18 written statements from two representatives of our company 19 that further elaborate on what we feel is the need to 20 grant this petition.

21 I can read those aloud or if you have any 22 questions about what we are trying to do, we will 23 certainly entertain those questions, if you all have any 24 need for further information.

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il 178 1 the right to ask you some questions as we proceed.

f 2 MR. COMBS: Sure.

3 CHAIRMAN SIEGEL: What would be the mechanism, 4 assuming you all decided that is what you wanted to do for 5 reestablishing general licenses?

6 What would that require mechanically?

7 MS. TROTTIER: It would simply require us to 8 publish a proposed rule with the decision to do that.

9 There.is nothing unique about doing that. We could go 10 ahead ar.d do that, I believe.

I 11 CHAIRMAN SIEGEL: If you were going to, is it 12 likely you would do it for this specific -- in response to 13 this specific petition or would you rethink the existence k

14 of general licenses in anticipation of future tritium and 15 C-14 diagnostic tests?

16 MR. CAMPER: That is an interesting question 17 because what we would do is we would prepare a commission 18 paper, as Cheryl is pointing out, and we would go back to 19 the commission and recommend -- it really is a policy 20 issue, that the general license category that existed i

21 previously in 35.31 of the old part 35 could be l

22 reestablished. That is an option.

23 Now, then you have to ask yourself, "Well, i

24 okay. If you go the route of the general license, is it ;

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179 1 one procedure?"

2 At least my initial blush on that is -- and 3

this is not a conclusion -- is that is a jump. That is a 4 reach because if you go back and you look in the 5 statements of consideration that accompanied the '87 rule 6

change you will find some things that say the following:

7 "NRC believes it is no longer efficient to issue medical 8 general licenses that allow the administration of by-9 product materials to humans.

10 "The tests authorized under 35.31 have been 11 superseded by newer procedures with greater diagnostic 12 accuracy.

13 "These developments have been reflected by a 14 significant decrease in applications for general 15 licenses."

16 To determine the status of general licenses, 17 the staff performed a telephone survey of 10 percent of 18 the then-current registrancs.

19 The survey results indicated that less than 9 20 percent of all of the current registrants still use 21 material for medic use under general license.

22 Now putting that differently, is that of the 23 registrants at that time, and I don't know the total 24 number, 9 percent were still using, but the commission

/ 25 opted to move away from the concept of the general NEAL R. GROSS count aspomuns um inmecanum 1833 nM30s mLAND AVBdWE. N.W.

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2 f

t So then you have got to ask yourself, "okay, 3 if we go back and suggest the option of reestablishing it, 4 and you are doing it on only one test, one modality, is 5 that worthwhile?"

6 I don't knew. It is a reach I think, but by 7 the same token, if there were other procedures, then there !

8 could be more validity to that.

9 Another option would be the idea of the exempt {

)

10 distribution, but that poses some problems that really we I l

11 would like to get at from this committee; not the least of 12 which is if you did it under an exempt distribution bear 13 in mind that at least regulaterally, in terms of our 14 parlance, you would not have to be in a position that 15 administered the material.

16 MS. TROTTIER: Right. Anyone has the ability 17 to use exempt material.

18 CHAIRMAN SIEGEL: All right.

19 MEMBER SWANSON: If I could ask somebody from 20 the company, how is this being regulated by the FDA?

21 MS. HOFFMAN: Hi. I am Susie Hoffman with 22 Tri-Med. The application for the NDA is currently in i

23 front of the FDA for approval, and the test would be 24 prescribed by a physician, according to FDA regulations.

25 MEMBER NELP: And it is in what committee? Is NEAL R. GROSS couw neomuns um nweenmus 1333 nmo 0E mLAND AVENUE. N.W.

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n V

2 3

MS. HOFFMAN:

MEMBER NELP:

It is under GI.

Under GI?

4 CHAIRMAN SIEGEL: Yes, but so it is not going 5 to medical imaging drugs advisory committee.

6 MR. COMBS: They are to reviewing portions of 7 it that are relevant. So it is being evaluated by several 8 different --

9 CHAIRMAN SIEGEL: I am sorry. You have got to 10 use the microphone. Good point. Actually I think the

(

11 comment you just made about distribution is really less of 12 a problem because this would be a product approved by the .

(] 13 Food and Drug Administration as a prescription drug.

14 Consequently, that, drug can only be given to a 15 human being upon the prescription of a licensed physician, 16 and although it could be administered by a non-physician, 17 you can't get your hands on the drug without a 18 prescription.

19 MR. CAMPER: Right. The other thing that is 20 interesting in this regard is I am unaware of any other l

21 exempt distribution that we authorized that is for 22 administration to humans.

23 MS. TROTTIER: That doesn't mean it wouldn't 24 be approved, but I mean currently it is --

fs\

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liko smoke datoctors and certain other datection devicca e 2 and things like this, but not for human use.

(

3 CHAIRMAN SIEGEL: So the reason for making its 4 distribution exempt is so that it can be distributed to 5 other than licensee's?

6 MS. TROTTIER: Correct.

7 CHAIRMAN SIEGEL: You are still covered by the 8 fact that it can only be -- well, it can't only be 9 distributed to physicians but it can only be administered 10 upon a physician's prescription.

11 Am I correct on this?

12 MEMBER SWANSON: Correct.

p 13 CHAIRMAN SIEGEL: Okay, but you are right. It

('

14 could be held by a clinical laboratory where no physician 15 was physically involved in running the clinical 16 laboratory.

17 Well, it is an interesting question. I can 18 tell you the average nuclear medicine department in the 19 United States isn't prepared to do this test because they 20 don't have a liquid scintillation counter.

21 MEMBER NELP: Do they send the collected 22 samples back to a central location?

23 MR. COMBS: Again, this is Matt Combs from Tri-Med.

(O 24 Maybe I will describe a little bit about the 25 test.

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The test is expected to ba performed by sites 2 that have liquid scintillation counting facilities. We 3 will offer the service of counting the samples by Tri-Med 4 in either regional counting centers or through Tri-Med.

5 So for instance, a radio pharmacy in, say 6 Baltimore, may set up a counting facility as well. So i 7 when they deliver their doses every morning, they would 8 pick up balloons from yesterday and analyze those, because 9 we utilize just a mylar balloon in the kit that the 10 patient blows up, and then extract the CO, out of that 11 breath in the balloon.

12 CHAIRMAN SIEGEL: So just out of curiosity. j l

13 Why did you choose a mylar balloon rather than a hyamine l 14 to trap the CO?

15 MR. COMBS: That is a good question. It is 16 patient safety, actually, because the hyamine is caustic 17 and it is possible, not likely, that the patient could 18 somehow inspire hyamine directly.

19 Whereas, here we remove the patient from the -

20 - from handling the caustic hyamine.

21 MEMBER NELP: What if the balloon breaks? j 22 Then you have to repeat the test. Right?

23 MR. COMBS: Well, first of all -- l 24 MEMBER NELP: Or do they get more than one O

1 25 balloon? ,

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184 1 MR. COMBS:

You can have more than one balloon

-s 2 if you so choose.

We found that one balloon is

\-- 3 sufficient. These balloons are very tough.

4 We haver performed a lot of experiments on the 5 ballocas. They don't break very easily. It is pretty 6 hard.

7 CHAIRMAN SIEGEL: If you have ever gotten one 8

as a present you realize that they stay on the ceiling for 9 weeks on end and you can't do anything about it.

10 Another regulatory question, and that 1-s: If 11 a laboratory chose to perform this test, what level of 12 complexity will this test be classified with respect to x 13 the clinical laboratory improvement act?

14 I can see -- we are all sitting here worrying 15 about the average physician wanting to do this -- this 16 gastroenterologist -- wanting to do this test in his own 17 lab, but if right now he is only doing a urinalyses and an 18 occasional hematocrit and he is classified as a low 19 complexity lab under CLIA, and this converts him to a high 20 complexity lab under CLIA, that physician is going to 21 choose to say, "Thanks, but I am going to let somebody 22 else do that test."

23 MR. COMBS: Yes. This test hasn't been

,_ 24 classified by CLIA, but we believe it will be a moderate s- 25 complexity test.

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185 1 MEMBER NELP: Moderate complexity?

2 MR. COMBS: Yes. Especially if the site does d 3 not perform their own counting, because that is where most 4 of the complexity comes from.

5 The other part of the test is you just take a 6 pill, and 10 minutes later you blow up a balloon.

7 MEMBER NELP: Quite simple.

8 MR. COMBS: Yes. It is very, very simple.

9 CHAIRMAN SIEGEL: It is pretty straight-10 forward. It is the counting mode that is the problem, and 11 currently CLIA regulations for moderate complexity tests 12 are fairly onerous.

13 There are things going on, on the hill, people 14 are trying to back physicians offices out of CLIA as we 15 speak, maybe not today, but there is a lot of activity and 16 pressure from the AMA to get things to back off a bit on 17 CLIA, and I don't know whether any of that will go down.

18 MEMBER SWANSON: Larry, if this is done under 1

19 a general license rather than an exemption, is there any l 20 problem with the physicians' office sending the C-14 l 21 balloon back for analysis?

22 MR. CAMPER: No. No.

23 MS. TROTTIER: That would be evaluated during 24 -- while they did the safety analysis anyway, but I can't 25 imagine.

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186 1 MR. CAMPER: Yes. That is a good point. No I 2 matter which way we were -- either approach, exempt or 3 general, there would have to be a safety analysis to 4 accompany it.

5 CHAIRMAN SIEGEL: If it is exempt is'it likely 6 that there will be a possession limit? Is that built in 7 to the exemption?

8 I mean, what I am trying to think about, let's 9 think about what could go wrong. Why would we not want 10 this safe drug in the hands of gastroenterologists,.

11 internists, pediatricians, for that matter.

12 MS. TROTTIER: The safety analysis would 13 address possession of multiple dose kits, say, or Os 14 capsules. I mean, whatever this is.

15 That would be done. It would be considered in 16 the transport and all of that. You know, that multiples 17 were being shipped, but I don't -- it wouldn't be in the 18 regulations.

19 CHAIRMAN SIEGEL: What I am driving at is the 20 issue -- I think most of us would agree that the radiation 21 exposure from one microcurie capsule of C-14 urea is 22 negligible, that we are not worried about the radiation 23 safety aspects of that to the patient.

24 One could conceive, and especially given some

(,\

25 recent activity of someone trying to o.d. on C-14 urea, NEAL R. GROSS couw nanomuns me meecausas 133 nHODE MLAND AVs NUE, N.W.

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187 I which is going to be tricky; and so if a practitioner has 1 2 thousends of these capsules, such that it is possible to 3 ingest a millicurie of C-14 urea, then there might be an 4 issue of concern to the NRC.

5 On the other hand, if the way this stuff is 6 going to be distributed is that no one practitioner could 7 have in his possession more than 20 of them at a time, it 8 is kind of a no-brainer from a radiation safety point of 9 view.

10 MR. CAMPER: On your question on possession, 11 there is no specification of a possession limit.

12 What happens under our E-distribution, there

-1 13 is a category, there is a product that is categorically 14 provided an E-distribution vehicle.

15 CHAIRMAN SIEGEL: Okay.

16 MR. CAMPER: In the course of having that' 17 product approved for E-distribution they present certain 18 information that is designed to satisfy safety analysis 19 requirements in part 32, and they make assumptions about 20 the population of the product and present some scenarios -

21 -

22 CHAIRMAN SIEGEL: Right. So if I choose to 23 build my house out of smoke detectors --

24 MR. CAMPER: Right.

25 CHAIRMAN SIEGEL: I would be 92 standard NEAL R. GROSS counr nanomine ANo iweenmen 1303 RM00E WLAND AVENUE, N.W.

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188 1

deviationo from the mann in terms of smoke detector 2 density, but I suppose there is no way to regulate that?

3 MS. TROTTIER: Right. You can build your 4 house out of smoke detectors if you want to.

5 MR. CAMPER: You certainly can.

6 CHAIRMAN SIEGEL: Now, what would my dose be 7 if I did, just out of curiosity.

8 MR. CAMPER: Not much. You wouldn't have to 9 worry about fires.

10 CHAIRMAN SIEGEL: Matthew? .

11 MR. COMBS: I would like to respond to the 12 possession. I don't know whether this is relevant or not, p 13 but we have requested a limit of 150 of these capsules at 14 any one site.

15 That is based on physicians being able to 16 order them in lots of 100, and when they get halfway 17 through their first lot of 100, if they buy them that way, 18 to be able to order another one. So they wouldn't run 19 out.

20 MEMBER WAGNER: Who would regulate that?

21 ,

MR. CAMPER: Pardon?

l 22 MEMBER WAGNER: Who would regulate that, 23 having 150 on site? No one.

24 MS. TROTTIER: Not if it was exempt.

f 25 MR. CAMPER: Again, the 150 is something that NEAL R. GROSS I coun ascomuns um vnaNemsens tags aMOOE ISLAND AVENUE. N.W.

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189 1 the patitionar has specified, but wa would not put that 2 limitation, an E-distribution doesn't work that way.

3 It is the individual product is approved under 4 an E-distribution scenario.

5 MEMBER NELP: The FDA doesn't have any role in 6 limiting the amount of any material in possession of a 7 physician. Is there any way you can?

8 MEMBER WOODBURY: Not unless the amount given 9 would exceed acceptable limits. With the amount given 10 here I don't think that that would be a problem. .

11 MEMBER NELP: No, but in terms of the number 12 of pills, I could write a prescription for 1,000 pills if 13 I wanted to.

14 MEMBER WOODBURY: Right.

15 MEMBER NELP: I would make the company happy, 16 but you don *t have any way of limiting my ability to 17 prescribe? For instance, if I went into the drug store 18 and ordered 1,000 tablets of codeine, they wouldn't sell 19 them to me.

20 DR. SIEGEL: With good reason.

21 MEMBER NELP: Exactly, I always order small 22 amounts and say, "What's up?" There are some internal !

23 controls in the drug distribution.

24 MEMBER WOODBURY: Usually the label insert, if 25 the FDA approves it, the label insert will give NEAL R. GROSS l ooum an Ome == =Na>asas 133 RMODE ELAND AVENUE, N.W.

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190 1

recommanded dosas or recommanded rangos, but this would O 2 not preclude you from ordering.

b 3 MS. TROTTIER: I have question that is non-4 regulatory. Can I ask it?

5 CHAIRMAN SIEGEL: Sure.

6 MS. TROTTIER: It is informational. What is 7 the cost to work up the diagnosis of duodenal ulcer using )

8 this technique, which has to be considerably less 9 expensive than endoscopy, biopsy, et cetera.

10 Can you give me ball park figures? ,

11 MEMBER NELP: Within $100.007 12 CHAIRMAN SIEGEL: Well, inverse is the 13 strategy of just treating.

14 MS. HOFFMAN: I think that the ACG, the 15 American College of Gastroenterology has put a lot of work 16 into this recent, and the NIH recently had a consensus 17 conference and stated that the breath test was the most l

18 accurate way of diagnosing ilichypogastric pilary and that l 19 all patients with ulcer disease should be tested for 20 iliohypogastric pilary and treated.

1 21 Basically it is going to be a lot less 1 22 expensive than endoscopy.

23 CHAIRMAN SIEGEL: What about the competing 24 technology which I uncovered in my literature searches of 25 using mass spec --

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191 1 MS. HOFFMAN: The carbon-13?

2 CHAIRMAN SIEGEL: C-13.

l 3 MS. HOFFMAN: Well, neither test is out on the 4 market at this point, but we believe that the carbon-14 is l 5 going to be less expensive.

l l 6 Initially, if you have your own counter, your 7 own scintillation counter, you can do you own analysia. A 1

8 lot fewer places have their own mass spectrometer, which <

9 is required to analyze the carbon-13. l t

10 MEMBER NELP: Do you have a cost projection 11 for a capsule?

12 MR. COMBS: We don't at this time because a f- s 13 lot of this depends on how long it takes to get approval,

(

14 and there are a lot of factors.

15 So I don't want to say what we think it will 16 be because I don't want to be held to that.

17 CHAIRMAN SIEGEL: Can you tell us whether we 18 are talking about tens of dollars, hundreds of dollars, l l

l 19 thousands of dollars or millions of dollars? )

20 MR. CAMPER: There are some numbers in your l l 21 petition.

22 MS. HOFFMAN: Right. For the capsules 23 themselves we are looking at tens of dollars.

24 MR. CAMPER: In their petition under the O

k.s 25 paragraph identified as, " Benefits of the Test," they NEAL R. GROSS cou m aspo muRsANo w Nem mes taat RMODE WLAND AVENUE N.W.

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192 1 point out that the C-14 uroc breath test could be done by

(

i 2 most doctors for less than $100.00 cost to the patient.

3 "This is a considerable cost savings over 4 endoscopy and biopsy. The benefits to the public are that 5 curative therapy for ulcers will become available to all, 6 saving the United States an estimated 500 million dollars 7 per annum over conventional therapy."

8 That is pretty much where you -- do you still 9 feel the same way today?

10 MR. COMBS: Yes, but whether it is $50.00 or 11 $150.00 or $200.00, we can't say at this time, but it is '

12 approximate.

p 13 MEMBER NELP: The longer it goes divided by 14 the government, the more expensive it becomes.

15 CHAIRMAN SIEGEL: That's correct.

16 MR. COMBS: But the idea here is to offer 17 something as low cost as we can because we are committed 18 to that.

19 CHAIRMAN SIEGEL: Do you all have a sense yet 20 about where the environmental impact analysis is going to 21 go down?

22 Does this strike you as a particularly great 23 environmental impact concern?

24 MS. TROTTIER: No.

25 CHAIRMAN SIEGEL: During the time we have NEAL R. GROSS ;

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1 193 1

spoken hero moro C-14 was generated in the atmosphere by O 2 cosmic rays than is likely to be used over the next decade 3 for this test.

4 MS. TROTTIER: Yes. The biggest issue right 5 now is simply that this work has to be done. We can't do 6 anything as far as making a decision without the work 7 being done.

8 CHAIRMAN SIEGEL: I understand. I think we 9 can --

10 MR. CAMPER: Barry?

11 CHAIRMAN SIEGEL: Yes, sir.

12 MR. CAMPER: I have a question, just a 13 thought. I think that is an excellent point. The

[n\

14 environmental impact here is really not the deal.

15 CHAIRMAN SIEGEL: No. I'm not focusing on 16 that.

17 MR. CAMPER: I understand that. I think the 18 issue that concerns us the most is this regulatory 19 philosophy issue.

20 Do we move back toward the general license in 21 part 35, which was removed in '87 for the reasons I said 22 or conceptually how does the committee feel about the idea 23 that something would be distributed under the exempt 24 distribution scenario for human use.

p

( 25 Those kinds of things are ticklish.

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194 1 CHAIRMAN .iIEGEL: And I went to tackle that in 2 a slightly different way. Given that we don't know the 3 answer to the environmental impact, but we can assume that 4 it is not likely to be a deal breaker here.

5 I would then pose the question whether any of 6 us feels that the use of this radioactive drug in a 7 diagnostic test requires the level of training and 8 experience la.Ld out in 35.910, and requires institutional 9 or practice licensure under 35.100 in order to be able to 10 do this test safely from the viewpoint of patient safety, 11 occupational safety, and ultimately environmental safety.

12 MEMBER BROWN: And that is given that it will

-~s 13 always be prescribed by a physician.

-- 14 CHAIRMAN SIEGEL: It will be a licensed 15 prescription drug.

16 MEMBER NELP: I feel very comfortable with 17 having it be exempt under those conditions because it will 18 be or should be in the hands of responsible people, and 19 its certainly innocuous -- l 20 CHAIRMAN SIEGEL: And it is not like -- the 21 real issue here is radiation safety. It is not like the 22 use of this drug as a diagnostic test will be unregulated.

23 There is FDA licensing for test performance.

24 It will be interesting. I am wondering, in discussions O

_, 25 with the FDA has physician laboratory proficiency testing NEAL R. GROSS .

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195 !

I es part of ovantual distribution como up co something, as 2 a service the company is thinking of either offering or

>O 3 being forced to offer by the FDA?

4 There have been some recent imaging drugs, for 5 example, where interpretation is so complex that the FDA 6 is including in the labeling, like in order to be able to 7 use the drug you have go to have some training under 8 company tutelage in order to play the game.

9 MR. COMBS: Once again, wouldn't that fall 10 unt'er CLIA as far as the level of complexity for the 11 testing?

12 CHAIRMAN SIEGEL: That was my third level of l 13 regulation. CLIA will be regulating this also. I am also O

v 14 wondering whether discussions with FDA have included 15 anything specific in labeling.

16 MR. COMBS: Not at this time.

17 CHAIRMAN SIEGEL: Okay. So given that this 18 test will be regulated at several levels, it is regulated 19 as a prescription drug by the states.

20 It i; regulated by CLIA -- its use will be 21 regulated by CLIA. The chit will be regulated by FDA. I 22 don't think that any of us think that radiation or 23 occupational safety is likely to be a problem.

24 I think you could choose either strategy and

' (,/ 25 it works for me.

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m 196 i

The recaon you got rid of ganaral licensing is g

r 2 because it was withering. People weren't doing blood i

3 volumes in their offices anymore, and they weren't doing 4 Schillings tests.

5 It was hard for people to maintain the 6 equipment. There were very few people involved.

7 The only argument for reconsidering that is 8 that this may open the door to a substantial number of 9 other C-14 breath tests that have kind of languished:

10 bile salt breath tests, fat absorption breath tests, that 11 have been in regulatory, and consequently, clinical 12 development limbo because nobody really knew how they were i 13 going to find their way in the market place, and there may l

l 14 be a reason to choose considering general licensure if you i

l 15 think that there is some safety need to maintain controls.

16 Otherwise, I would frankly argue for 17 exemption. What do the rest of you think?

l 18 MEMBER NELP: I agree. I think it could be L 19 very nicely handled under exemption.

l 20 CHAIRMAN SIEGEL: And let the record show that !

21 the nuclear medicine physicians are not trying to claim 22 any specific turf here by saying that we are the only ones 23 who can do this test.

24 MEMBER NELP: I think the gastroenterologists 25 -- that's right, as long as they are board certified.

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N 197 1 MEMBER WAGNER: But you don't care by what.

(

2 board. Right?

3 CHAIRMAN SIEGEL: If my memory serves me 4 correctly, I think the physician who discovered that 5 ilichypogastric pilary was responsible for ulcer disease 6 just won the Nobel Prize for that or was it a Lasker 7 prise?

8 MR. COMBS: He just won the Lasker award.

9 CHAIRMAN SIEGEL: And so the clinical l 10 importance of this observation is pretty clear. This has 11 revolutionized the therapy of peptic ulcer disease. )

12 MEMBER STITT: Unfortunately, because the i 13 record should reflect that being from Wisconsin, we liked I

14 it when ulcer disease was treated with lots of milk.

15 This is to our disadvantage.

16 CHAIRMAN SIEGEL: Everycody has got a turf 17 issue to on the floor.

18 MEMBER STITT: I had to get that in there. l 19 CHAIRMAN SIEGEL: I think we have made our 20 recommendation. Any other comments? We could go either 21 way. '

22 I think whichever you guys think works better 23 -- clearly from a clearly paper trail point of view, and 24 in terms of minimizing the regulation, an exemption --

25 MEMBER NELP: Which is easier for the NEAL R. GROSS couw assomuns me r= -

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i $

198 1 manufceturor or corporation? Do you know, Larry? Which l .

2 would -- both ways would be supportive?

l 3 MR. CAMPER: I think either way would be of l

4 minimal burden. General license really wouldn't impose 5 any burden upon -- it would impose a little more of a 6 burden upon the one who wanted to use the lab because then 7 they would have to go through the old process we used to 8 go through where you would get a registration certificate 9 on record, and then a general license is issued.

10 Whereas, as compared under the exempt

)

11 distribution process it is exempt, and once it is exempt -

l 12 -

, 13 MEMBER NELP: I think the simplest should be 14 the preferred, if they are equal or comparable.

l l 15 CHAIRMAN SIEGEL: Btit under the new system, I l

16 am just going to open up that NRC's web page -- and I am l

l 17 going to fill out my application for general license under 18 the Internet, click on the submit button, and I will have 19 my license in an hour.

20 Isn't that correct?

21 MR. CAMPER: That's right. Yes. You will.

22 Let the record show that you will.

23 CHAIRMAN SIEGEL: The address is H2TP://WWW.

24 MEMBER NELP: How long will it take you to get O 25 the web page?

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3 199 1 MR. CAMPER: It will be five minutes in your p 2 case.

3 CHAIRMAN SIEGEL: Bob, do you have any 4 feelings about this from an agreement standpoint here?

5 MEMBER QUILLIN: The only thing I have been 6 thinking about during this entire process is that we have 7 suffered from several cases of generating license exempt 8 materials that were never envisioned as accumulating in 9 any one spot in any large quantity, but eventually did, 10 and I couldn't think of any way that this would happen 11 here, but I would certainly encourage that as a 12 consideration that this potential problem be addressed.

13 MR. CAMPER: Let me comment on that, just real 14 quick. I agree with you, in this particular case I 15 couldn't see some of the problems that I could see in some 16 other things, but there are some things going on today in 17 the distribution process that are a little disconcerting 18 to us, and it is not clear that things are going like they 19 were originally intended to go.

20 We do intend to take a look at what is going 21 in new distribution. Like, for example, watches that were 22 distributed initially under the exempt distribution 23 process end.up today being collected by the same company 24 for the purposes of repairing and fixing these watches,

(

25 and now suddenly you have a lot of these watches at one NEAL R. GROSS count aspomem ase nweeness tus aMo0E eLAfC AVENut. N.W.

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200 1 sito, that ware originally distributed under exempt

,e g 2 distribution, and that raises questions about was that the 3 original intent of part 32, but that really, I don't 4 think, has much bearing upon this.

5 We have had the same kind of observations that 6 you have had in Colorado.

7 MEMBER STITT: Do these capsules have a shelf a life having to do with just the capsule? That is, do they 9 dry out or gum up or is there some sort of --

10 MR. COMBS: The anticipated shelf life.is two 11 years, and that is based on --

12 MEMBER STITT: You could use them to stick s 13 your smoke detectors together.

14 CHAIRMAN SIEGEL: And once they expired-they 15 would simply be disposed of?

16 MR. COMBS: That is --

17 CHAIRMAN SIEGEL: Oh, we used the BRC word 18 here.

19 MEMBER STITT: I understand that when you make 20 an exempt decision you lose control of disposal.

21 CHAIRMAN SIEGEL: Right.

22 MR. COMBS: I believe we would say that they 23 would be returned to the manufacturer for replacement.

24 MEMBER QUILLIN: I would encourage that option C/ 25 rather than the direct disposal option because many local NEAL R. GROSS OOURT MPORTERS AND TRANGCRMEM 133 RMODE SLAND AVENUE, N W.

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201 1 governmant entities hcve banned the disposal of 2 radioactive materials in their landfills, directly.

3 That doesn't mean that it doesn't get disposed 4 of, but they have banned it.

5 MEMBER BROWN: So you would provide a 6 financial incentive for them to return it to the 7 manufacturer by giving them replacements?

8 MEMBER NELP: I would just put it down in the 9 sewer because there is more carbon-14 being formed than l

10 that in your own backyard. .

11 MEMBER BROWN: Other people might not like 1

12 that.

13 MR. CAMPER: Torre was pointing out --

14 CHAIRMAN SIEGEL: We can't have two i l

15 conversations at once. Dr. Wagner? Dr. Wagner, cool it.

16 MR. CAMPER: I was just pointing out, as Torre 17 was pointing out to me, that if it goes exempt, once it is 18 exempt, it is exempt.

19 Whatever arrangements the manufacturer has j 20 with its clients for the return of it is fine, and your 21 point is well made, but from a regulatory standpoint once ;

22 it is exempt, it is exempt.

23 MEMBER BROWN: So what they are saying is just

~_ 24 .their intention. There is nobody who is going to make

\ 25 them do that?

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202 i

I

.1 MR. CAMPER: There is no basis for making them i

2 do it.

3 MEMBER BROWN: Right... So they could be saying 4 that now, and then later say, well -- is it a concern that

, 5 these things will be disposed of in toilets and stuff?

i l

6 MEMBER NELP: No. It is done all of the time.

7 I mean we put thousands and thousands times greater l

l 8 activity down the sewers on an almost weekly basis from j 9 human excreta.

l 10 MR. CAMPER: The sewer part of it is.the easy 1

)

j 11 part. The part that Bob Quillin is getting at is even l 12 though in regulatory parlance we call it exempt, there is 13 a detectable amount of radioactivity there, and many of

\~

14 the landfills today, by virtue of the permits granted to 15 them by the local municipalities have zero tolerance for 16 radioactivity.

17 CHAIRMAN SIEGEL: They only have gamma 18 detectors. Is that right? Have you ever noticed?

19 MR. CAMPER: That's true.

! 20 CHAIRMAN SIEGEL: Here is -- I really propose 21 that this committee has made an important judgment for you 1

22 that we don't think the person using this test has to be l l

23 an authorized user under part 35. ;

24 Whether you all choose to do this under an 25 exemption or under a general license, based on whatever NEAL R. GROSS Coum apomuns me mancmeew tM nMODE MUWC AVENUE. N.W.

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203 i l

1 BRC fringa environm2ntal concerns you might have about l 2 this is up to you.

3 You must recognize that the amount of total 4 paper work load that you will have if you do it under a 5 general license is going to be substantial.

6 You will get a lot of applications because 7 this is a common medical problem and a lot of people are 8 going to want to offer this clinicall.y important test. )

{

9 MS. TROTTIER: Okay. All right. Thank you.

10 CHAIRMAN SIEGEL: Thank you. Cool. We.

11 actually finished something.

12 MS. TROTTIER: Done.

fN 13 CHAIRMAN SIEGEL: Can we go home? Okay. We N~Y 14 have finished lunch. It is now 1:00. Actually it is ]

15 2:00. We are exactly one hour behind schedule, and next 16 is a discussion of role of medical consultant, inspection 17 manual 1360, and Dennis Serig, you are going to speak to 18 us.

19 MR. SERIG: We have among us a number of 20 medical consultants. I think six of you sit at the table 21 here as ACMUI members, and then we have five of our non-l 22- ACMUI medical consultants sitting as part of the audience. l 23 CHAIRMAN SIEGEL: Can I invite doctors Almond, )

1

-s 24 Griem, who else?

\' 25 MR. SERIG: Mrs. Watson, Dr. Whittington. l NEAL R. GROSS 1 couw nanomes m0inmeaumans a nN00E ISLAND AVENUE. N.W.

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--~______

l 204 i CHAIRMAN SIEGEL: Yoo. I maan, there are at g-- 2 least two chairs open on this side and there are two other 3 chairs there that can be pulled up.

4 So if you guys want to join us at the table, 5 we would love to have you for this discussion. If it is 6 legal. Is it?

7 MR. CAMPER: That's fine.

8 CHAIRMAN SIEGEL: Thank you.

9 MR. CAMPER: It is illegal, but that is fine.

I l

l 10 We have to remind Peter, of course, that he can't vpte.

11 He is in the habit voting historically, having been a 12 member.

13 CHAIRMAN SIEGEL: And Dr. Marcus will have to

(

14 sit on the other side of the room.

15 MR. SERIG: Although these pieces of paper 16 that you have in front of your or you are seeing on the 17 screen have a lot of writing on them, I think that the 18 concern is a fairly simple one.

19 We have two pieces of -- or two documents 20 which direct that we use the services of medical 21 consultants under certain conditions. !

l 22 The slide here in essence says that when we 23 have a misadministration reported to us that involves an 24 over-exposure to the patient, then we are to use a medical i 25 consultant, read physician, in this case.

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W 205 i We may also, upon review of the event, choose f~') 2 to use a scientific consultant, read medical physicist.

J 3 In short, we have a requirement to use a physician 4 consultant and we may also choose to use a medical 5 physicist as a consultant.

6 The next page is an excerpt from another 7 document which helps to implement the management 8 directive, again, a lot of words, but basically there are 9 a number of other conditions under which we feel obligated i 1

l 10 to use the services of medical consultants. l l

11 Go one more page. Now we will get down to the 12 crux of it. Even though we have some guidance to the 13 staff that says, "You will, in fact, use a medical v

14 consultant under certain conditions."

15 When we call or the regions call the medical 16 consultant, you are fr'ee for any number of reasons to 17 refuse to provide that consultancy.

18 One of the reasons you might refuse is that 19 you feel this is not a case which really warrants the 20 services of a medical consultant, and that is the crux of 21 the matter. l 22 In our current mode of operation what we then 23 are required to do.is ask you to give a brief note that 24 explains your basis and we then transmit that to the

(~'

V 25 director of the division of industrial medical nuclear NEAL R. GROSS count nanomEns aNo mNecamens 1333 RMoOE ISLAND AVENUE, N.W.

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206 i

safety and ha makes the call as to whether or not we will

-s 2 use a medical consultant.

I

-- 3 What we would like to do, go to the final 4

slide, is ask you for your comments about ways we might 5 improve this.

6 I think some of the aspects are pointed out !

7 here. Even though you are refusing to give us your i l

l 8 services by stating that they are not necessary, you 9 actually do provide some service.

l 10 You provide us a note that explains why.not.

l 11 We would like to alleviate the need for the director to 12 make a decision which may be more appropriately made by l 13' medical personnel.

l

\s 14 We would also like to expedite this process.

l 15 We have the regions and the headquarters staff going back !

16 and forth for a day or two trying to do something which is I

17 very simple.

18 So if we could get your comments on those ;

1 19 things, and there is another issue that I think you can j 20 help us with, and maybe this is related to that.

21 It is the -- how soon we get medical 22 consultant reports. We are required -- the documents 23 require that we get a report within 30 days and sometimes l

24 we do, but quite often we do not.

, 25 If we can facilitate the process by screening NEAL R. GROSS couar aspomans Ano mascassas 1883 MMODE 10 LAND AVENUE, N.W.

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n l'

207 1 events, somahow wa would appreciate your input about that 2 type of situation as well.

\/ 3 CHAIRMAN SIEGEL: The typical contractor 4 letter that comes from the region to a medical consultant l I

1 5 says, "Please provide us with your report within 30 days 6 of completion of your analysis."

7 It doesn't say within 30 days of the phone 8 call that brought you into the loop, and sometimes the 9 analysis has involved getting additional medical 10 information that has taken a couple of months to get.

11 Now as I think I have said before, it is easy 12 to generate a first report and reserve the right to create f 13 an amendment in follow up at a later time, and then you i

t, 14 have solved that problem.

15 Let me ask, to focus, this simple following 16 question. How often has the director of INMS gotten .

17 notification that the medical consultant declined to 18 participate for the following reasons, feeling that a 19 medical consultant was not necessary, and has overruled 20 that opinion?

21 MR. SERIG: Never. Never has he overruled it 22 to my knowledge. l 23 CHAIRMAN SIEGEL: You have answered your own 24 question. The process is currently complex because you

(_ 25 are requiring it to be complex, and I think that if a NEAL R. GROSS am namnas meinueeneans 133 nMODa teLAND AVENUE, N.W.

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r %

208 1 m:dien1 consultant simply sayo first and follows with the 2

l(es t

written documentation that this case does not need a

\ 3 medical consultant because and articulates the reasons, 4 that person has made a professional judgment.

l 5 He or she puts his or her own credibility on 6 line by so doing, and why do you choose to second guess?

7 Go for it and let the regions go for it.

8 I would go a step further. I wish you would

! 9 take E-mail and not require a written letter. I was l 10 actually a little surprised, I think it was last week, to 11 find that a three paragraph E-mail response that 12 articulated my reasons for not consulting needed to be l

I 13 translated into a letter.

I i

14 MEMBER NELP: I have another question in terms l 15 of numbers. How often do you use medical consultants 16 during the course of the year, and how often do they deny l

17 to provide service because they think it is of minor 18 importance?

19 MR. SERIG: Over the last three years there l

20 have been on the order of 25 to 30 misadministrations that 21 were finally judged to be misadministrations, of those, 22 probably 10 to 15 required the use of a medical i i

~

l 23 consultant, of those probably 4 to 5 maximum were 24 situations in which a medical consultant was contacted and O

s- 25 said, "This is not a case where I need to be involved or a l NEAL R. GROSS coum Recomes um mNemmen 133 RMODE mLAND AVENUE. N.W.

M Medes WASHINGTON, D.C. MIM (SW) 2344433 l

209 1 medical consultant nacds to be involved," and to got more

-~

2 specific, usually those are small doses of iodine in a

-! 3 nuclear medicine situation.

I 4 MEMBER NELP: So once or twice a year the 5 situation comes up.

l 6 MR. SERIG: Correct.

7 MEMBER NELP: Those consultants apparently 8 have been given enough information to render an opinion 9 that their services are not necessary. So all you want to 10 do is get that in writing. .

11 MR. SERIG: Correct.

32 MEMBER STITT: Is that what they always are?

fs 13 Almost always?

14 CHAIRMAN SIEGEL: I am wondering if any of 15 them went to the wrong treatment site on brachytherapy 16 sources, you know, the thigh getting two rounds as opposed 17 to --

18 MR. SERIG: We believe that they could be, 19 that that could be the situation, but that has not been 1

20 the situation. l 21 Very often we end up sending anything having ,

22 to do with wrong treatment site and brachytherapy to OGC I 23 for a decision.

24 MEMBER STITT: Wrong treatment site usually is ,

25 also coupled with the intended treatment site didn't get NEAL R. GROSS COUmf REPORTERS AND TRANGCREERB 1333 RMODE WLAND AVENUE, N.W.

(305 3364433 WAGMINGTON, D.C. 30005 (30$ 3364433

r mmm 210 the right doso.

l I

1 So I don't think thct would fall into

(

f

-s 2 that category. Those are usually being viewed.

3 CHAIRMAN SIEGEL: Yes, I am talking about the 4 one where the source was being retracted intentionally and' l 5 then got stuck, hit between the thighs for 10 minutes

) 6 instead of going through in the expected 30 seconds, and 7 it ends up being called an unintended dose to the thigh, 8 which is less than the dose that would have occurred had 9 the treatment been conducted normally. At any rate --

l 10 MEMBER NELP: That is not in this domain. We 11 are not talking about that. It seems to me that you have 12 solved your problem.

13 If you call me up and ask me to consult on a 14 problem and I said, "Well, from what you say it really 15 doesn't need my services, but I will be happy to document 16 that in writing. Send me the data and I will send you 17 back a reason why I think it is not necessary." Is that 18 what you are asking me to do?

19 MR. SERIG: Yes. That is the current l

20 situation, and one of the concerns is that it is a little 21 back handad or gauche.

22 Your refusal is actually a consultation. You 23 provide information, and maybe one thought that you could 24 help us with is whether maybe this could be thought of as 25 a positive consultation.

NEAL R. GROSS couw assompe me 1- -

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211 1 Your consultation is that there is not a very f- 2 high likelihood of harm. You will write the note to that f

\ 3 effect, and you will charge us for a half hour's services.

4 MEMBER NELP: I might charge you for an hour, 5 that's my minimum charge.

6 MR. SERIG: Okay. I think that is the minimum 7 you can charge us, anyway.

8 CHAIRMAN SIEGEL: Actually, that's not true, 9 but that is okay. I think that is a wonderful suggestion.

10 Basically, if I think about every one of these that I have 11 asked not to participate in formally, then my response has 12 been, " Based on the nature of this event further services 7-ss 13 of a medical consultant are not required."

'/ 14 I will give a couple of reasons, and I will 15 usually enclose a final paragraph which says, "If you 16 later discover that you wish me to review the licensee's 17 response to the incident or the information provided by 18 'the licensee to the patient, holler, and let me know, and 19 I will do it."

20 I think it is pretty easy.

21 MR. SERIG: Okay.

22 CHAIRMAN SIEGEL: Anybody else have a problem 23 here? Evelyn.

24 MS. MATSON: No problem, just a question. I

\_/ 25 think what has been addressed so far has been the NEAL R. GROSS ODURT REPORTERS AND TRANSCMSERS 1855 RMODE MLAND AVENUE, N.W.

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l 212 1 physicinn's position, rathor than strictly a madical

!( h

?

2 consultant, and so what is the policy as to the scientific

\-- 3 consultant, for example, the dosimetrist, the person who l

l 4 reviews the dosimetry or the data concerning the incident

! 5 and then comes up with the radiation dose.

6 Is that an automatic thing to be done in j 7 instances like this?

l l 8 MR. SERIG: No. It is not.

l 9 MS. WATSON: Do you go to the physician first 1

10 and then decide whether to --

l 11 MR. SERIG: It has happened both ways.

j 12 MS. WATSON: Okay.

13 MR. SERIG: There have been occasions when the l

l 14 region was concerned about whether or not something was of l

l 15 misadministration because they were concerned about the l

16 dose assessment, and went to the medical physicist first, l 17 and the medical physicist, having decided that yes, there l 18 was a difference in the prescribed dose from the actual l

19 dose sufficient to make a misadministration, then they j l

i 20 went to a medical consultant. ]

! l 1

l 21 There have also been cases where a medical 22 consultant has said, "I think I need help from a 23 scientific consultant." So it has gone both ways.

24 MS. MATSON: That doesn't present a problem, 25 really.

~

NEAL R. GROSS cous nemuuns me TmNeonnem 133 MN00E ISLAND AVENUE, N.W.

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M E344em WASNeeSTON, D.C. 30003 (SOE) 3344433 l j

~]

213 1 MR SERIG: No.

2 MS. WATSON: Okay.

k 3 CHAIRMAN SIEGEL: So, I guess, if I am hearing 4

-the group is acknowledging, what we are agreeing on, is 5

that we would say that if a medical consultant tells you 6

that he or she sees no need for further evaluation beyond 7 review of the information provided in the preliminary 8 notification and/or the conversation with the person in 9 the' region who made the contact that you all should accept j 10 that as the basis for moving forward. ..

11 MR. SERIG: Without the additional step of 12 bringing the director into --

13 CHAIRMAN SIEGEL: Given that you have not

\ 14 overruled, it seems like it is not adding much in the way !

15 of a great safety net for you.

l 16 I think that if something looked strange in a 17 given event, that you all would be discussing it enough 18 between headquarters, the region, OGC, and all of the 19 other. people who tend to get in the loops on these things, 20 that if Larry or Dr. Cool felt that the medical consultant

~

-21 said he didn't need to be involved here, but this doesn't 22 sound right, then pick up the phone and call him again or 23 her again, and say, "We would like you to reconsider, and 24 we would like you to take a look."

25 MR. ALMOND: Or couldn't they get a second NEAL R. GROSS couw nanomme me ww.sonese i m Iteo0E 2.m W AWWEE.N.W.

(ssi 3BMW umeMeegTON, D.C. 31885 WDR23H4M

214 1 opinion from anothar consultant?

s 2 MR. CAMPER: They could.

N/ 3 CRAIRMAN SIEGEL: Right, but in general I 4

think we are making this more complicated than it really 5 is.

6 MR. SERIG: I think that is really what we are 7 trying to do here, is simplify this, and yet not leave out 8 anything that needs to be done, and toward the point of 9 simplification, E-mail of a response seems reasonable to 10 me if we can make that work within the frame work. ,

8-11 MR. CAMPER: Well, that is the point I was 12 going to raise. The second bullet there, the idea of some 13 pre-established vehicle that could be used, one of the l

\-

14 problems we have with the E-mail is the idea of a record 15 for posterity.

16 CHAIRMAN SIEGEL: Print it.

17 MR. CAMPER: Well, we could print it out.

18 That is true. We could just print it out. That is a good 19 point.

20 Is there any value to a standard letter that 21 could be used for documenting the declination?

22 MR. SERIG: I think the question is probably 23 one that has to do with the specifics of what you would 24 write, and maybe there is such variety that you couldn't 25 do that, and maybe -- I don't know.

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\ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .

1 CHAIRMAN SIEGEL: The only thing I can think i 2 of is if you or OGC thought there was some need for some 3 boilerplate in such a letter to make it fulfill your 4 int _ernal needs, then you could put it in the letter, but 5 it certainly isn't going to facilitate what we tell you.

6 DR. GRIEM: On one occasion someone contacted 7 me on a well logging source that had been an industrial situation that messed up and a number of people were 8

9 exposed, and I would presume that you do it the same way 10 as the medical situation?

11 MR. SERIG: Yes.

12 CHAIRMAN SIEGEL: I would think so.

13 MR. CAMPER: Yes. That is true.

14 CHAIRMAN SIEGEL: All right. Have we reached 15 closure on this? So I think our consensus is that giving 16 you the consultation that telling you that no further 17 evaluation is necessary constitutes a consultation, and l

l l 18 that it need not be reviewed further per our 19 recommendation, by the director of IMNS, and we leave it 20 up to you whether you need a fcrm letter of some sort to l

21 fulfill some legal requirement.

22 MR. CAMPER: That's fine. I want to thank the 23 consultants who came in to participate in the 24 deliberation, and also, I want to thank you now for the 25 help you have provided in the past or thank you in advance NEAL R. GROSS couw nEpomuns um rweecamEns 13t3 RMODE 10 LAND AVENUE. N.W.

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216 1 for any h21p you might provida in the future.

2 Let's hope there is little of that, but 3 seriously, you do provide a very valuable service to us.

4 When we are dealing with these events you 5 provide a level of expertise and attention that we can't 6 provide, and ultimately your report is a significant 7 component in the final analysis of the event, and we thank 8 you for that, very much.

9 MR. SERIG: And you also put up with a great 10 deal, and have over the last month in providing paper work 11 to get yourselves reappointed, and we appreciate that.

12 MEMBEF STITT: Larry, just a chatty point 13 here. Your associate next to you is so enamored with E-lO 14 mail, as you know, and I do enough medical censultings 15 that I have put the NRC form on my computer, and so when I 16 am writing a report it is on my computer and I make a hard 17 copy for myself.

18 I have sent my report by E-mail as an attached 19 document because whenever I have a region that calls in or 20 a state that calls in I get their fax number.

21 We are doing business by fax, hard copy is 22 easy to generate on either end, and they are able to look 23 at something as I have it completed, and then I usually j l

24 print one out for myself and one to send them.

U 25 I use the form for format, and I don't end up NEAL R. GROSS coum assomens me maNecamans tus nMODE WLAND AVs NUE, N.W.

(act 2 Sue 3B WASHINGTON. O C. 30005 (30m 2364433

217 1 typing stuff on that piece of paper that I get sent 2 because I do a fair number of them, and it is easier to do O" 3 it this way.

4 This is just commentary. I don't know if you 5 have a response back to the electronic version of things.

6 There is as much security in that as there is in the U.S.

7 mail.

8 CHAIRMAN SIEGEL: You could have the region do 9 a telephone notarization of the E-mail message. You know, 10 subscribed and sworn to this day with three people on the 11 phone. I think E-mail ought to do the job.

12 Okay. Next. The manual chapter on follow up.

p 13 Who is going to present this?

14 MR. CAMPER: Cathy Haney.

15 CHAIRMAN SIEGEL: Cathy. We have lost her.

16 Okay. We are done.

17 MR. CAMPER: The next issue is discussion of 18 NUREGs. Isn't it?

19 CHAIRMAN SIEGEL: Dennis just walked out the 20 door. Well, I have got the wrong version of the agenda, 21 then. Torre. You have an old version of the agenda.

22 MR. CAMPER: That figures.

23 MS. TAYLOR: That had to be switched to 24 accommodate Cathy Haney.

25 CHAIRMAN SIEGEL: The manual chapter on 1 NEAL R. GROSS coum neomas me vnaMecamen 1M3 RMODE mLMC AVDfUE, N.W.

(30E) 334443 WAAMNGTON. D.C. M005 (30E) 2344433

3 218 1 patient follow up in tha correct version. NUREGs is on S 2 for tomorrow.

3 MR. CAMPER: Well, your highness, you seem to 4 have the correct agenda.

5 MEMBER BROWN: Esteem highness.

6 MR. CAMPER: Your esteemed highness, your 7 regalness. It shows you who ranks around here. Right.

8 CHAIRMAN SIEGEL: How about we go off the 9 record.

10 (Whereupon, the proceedings were briefly taken 11 off the record at 2:23 p.m.)

12 MR. CAMPER: Did everyone meet Dr. Ramirez 13 today? Dr. Ramirez. Does everyone know her? She is N- 14 visiting us from Spain. She is a physician, and she is 15 involved with the regulatory program in Spain.

16 She is spending six months with us to learn 17 more about the licensing and the inspection process and la the regulatory process at large.

19 So make it a point to say hello and chat with 20 her.

21 CHAIRMAN SIEGEL: Okay. We are back on the 22 record and Cathy, you are on.

23 MS. HANEY: Okay. Thank you. What I would 24 like to do today is just give you an overview of where we 25 are on patient follow up.

NEAL R. GROSS count nanomans Am0 mmecamans 1333 nHODE WLAND AVENUE, N.W.

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1-219 1

I guoos it was Novembar, 1994, was the last 2

(p,s\ time we spoke with you about patient follow up, and just

(_-) 3 as a status report.

4 What I have up on the screen, and what you 5 have on an overhead is the NRC's current policy on patient 6 follow up. i 7 This comes out of management directive 8.10, 8 which is the NRC management directive for dealing with 9 follow up on medical events, and it is used by the regions 10 when they are following up on misadministrations.

11 It basically says that in the case of where 12 there is an indication by the medical consultant that

_s 13 there could be long term effects, the director of NMSS in i

14 conjunction with our executive director for operations, 15 will make a decision whether a long term medical 16 consultant should be -- or long term follow up should be 17 done on a patient.

18 In the November, 1994, meeting the issue of 19 patient follow up was discussed at some length. This is a 20 quote that I took out of the minutes of that meeting.

21 There were two possible goals that came out of 22 that meeting, but there were caveats that were associated 23 with both of them.

24 Basically, what we want to let you know is 25 that we heard what came out of the November, 1994, NEAL R. GROSS oOunt nanomas AND mmemeens 1883 aMODE ISLAND AVENUE, N.W.

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220 1 meeting, and in conjunction with the next slide, which is j

] 2 our experience to date with patient follow up, where we d 3 are going.

4 We have followed one patient for a year. This 5 would be the end of the year, this October. We have 6 received monthly reports on the patient's status.

7 The reports have been reviewed by the regional 8 and headquarters staff. Once they have been reviewed by i 9 that staff they have been reviewed by upper management at 10 NMSS on a monthly basis at our monthly operational events 11 briefings.

12 So we have been following the reports that we 13 have gotten from the licensee.

14 CHAIRMAN SIEGEL: This has been a single case?

15 MS. HANEY: One case. Right.

16 CHAIRMAN SIEGEL: Can you give us a little 17 information about the nature of the exposure without l 1

18 revealing any proprietary information?

l l

19 MS. HANEY: I would leave that to Larry or 20 Josie to do. I don't know how much information can be 21 released.

22 MS. PICCONE: This was the case of the 23 prostate therapy where the seeds ordered were 10 times --

24 CHAIRMAN SIEGEL: Okay. Right. So we are

- 25 aware of this case, and we have discussed this previously.

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9 221 1 MR. CAMPER: Order of magnitude error in the 2 seeds.

3 MS. HANEY: Okay. So where we went from there 4 is based on these two items a draft guidance document was 5 prepared, and it basically reiterated the guidance that 6 was in 8.10.

7 We received some comments on it, but again, 8 based on what we kept -- the recurring theme from the 9 ACMUI in the November meeting, as far as what we learned 10 from this patient that we have followed, we have decided 11 to put the finalization of that chapter on hold, and it 12 probably will not be revisited again until'after we 13 receive the NAS study.

14 That is where we are right now on patient j 15 release.

16 CHAIRMAN SIEGEL: Patient follow up.

17 MS. HANEY: I mean patient follow up. I have 18 patient release left in my head.

19 CHAIRMAN SIEGEL: I wish we were in this good 20 shape on patient release. Okay. Comments? Do you have 21 specific questions?

1 22 MS. HANEY: No. I have no specific questions.

23 This was just intended to be a status report.

24 CHAIRMAN SIEGEL: It was scheduled for an 25 hour. That is the only problem.

4 NEAL R. GROSS ;

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]

222 1 MS. HANEY: We are trying to catch up on 2 schedule.

)

3 CHAIRMAN SIEGEL: We are now ahead of 4 schedule.

5 MS. HANEY: I ran upstairs, cut my schedule to 6 get my presentation down.

7 MR. CAMPER: I think that Cathy's last point -

8 - when the agenda was put together we had originally 9 intended to talk with you about some specifics in the 10 guidance on the patient follow up issue, but subsequent to 11 that we have decided to table that and talk about it when 12 we talk about the program at large after the NAS report.

13 So that changed it quite a bit.

14 CHAIRMAN SIEGEL: Okay. Thanks, Cathy. Any 15 other comments or thoughts on that?

16 So really, the bottom line is that patient 17 follow up is not something that is needed very often, nor 18 did we expect that it would be.

19 Are you learning from these monthly follow ups 20 information that you think is useful to the NRC?

21 MR. CAMPER: No. Not really. The patient's 22 condition is progressing as you might have anticipated.

23 There has been nothing striking or alarming.

24 Occasionally there will be events that O

V 25 arguably warrant following, but they are rare.

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223 i CHAIRMAN SIEGEL: Okay. We are like way ahend

/

e 2 of schedule all of a sudden, after being way behind

\

3 schedule.

{

4 Pat Rathbun is not going to be available until 5 around 4:15, I am told because she was up in Gaithersburg.

i 6 I was speaking with Cathy earlier and the option was )

i 7 whether she would come tomorrow morning, because it would 8 only take a few minutes, versus coming later, and she is i l

9 coming later.

10 I think to do the modules we need Trish, who 11 is not here.

12 MR. CAMPER: She is apparently in a meeting 13 right now.

Oi 14 MS. TAYLOR: She won't be here until 3:30.

15 CHAIRMAN SIEGEL: She won't be here until i

16 3:30. That means we have an hour. We can open up the 17 whole discussion of training for cardiologists.

18 MEMBER BERMAN: That's a good idea.

l 19 CHAIRMAN SIEGEL: Not a chance, Dr. Berman.

20 There is no background material for me to look at. I 21 won't know what to say.

22 MEMBER BERMAN: That is a good idea. We can 23 talk about what concurrent means.

7 24 MS. TAYLOR: Since we have a closed session

[

\ 25 tomorrow at 8:30, we could possibly go ahead and do that NEAL R. GROSS count neomas ue inmecansse 1333 nH00E WLAND AVI!NUE, N W.

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~

224 1 now.

fm 2 MR. CAMPER: Which one?

3 94S. TAYLOR: We have a closed session tomorrow l 4 at 8:30.

5 CHAIRMAN SIEGEL: How many members of the 6 general public, non-NRC staff are in the audience who 7 would have to thrown out for a short period of time if we l

8 had a closed session?

9 MR. CAMPER: Four.

l 10 CHAIRMAN SIEGEL: Okay. You have got your 11 hands raised. Now put your hands down. How many of you

! 12 care if we throw you out for a short period of time?

13 No one raised their hands.

,(r l.

l 14 MEMBER OF THE AUDIENCE: Are you buying the 15 coffee, Barry?

16 CHAIRMAN SIEGEL: Only if I have to. We could 17 do that. Who is going to present that?

l 18 MS. TAYLOR: Sally. We just need a few 19 minutes to pass something out. j 20 CHAIRMAN SIEGEL: All right. Why don't we go )

l 21 off the record for a second.

22 (Whereupon, the proceedings were taken off the 23 record at 2:32 p.m. and resumed in Closed Session.)

24 0

25 NEAL R. GROSS 00uc nanomem me vnaNecanEns 138 4400E M AVENUE. N.W.

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\;

280 1 P-R-O-C-E-E-D-I-N-G-S t

2 (4 :25 p.m.)

3 CHAIRMAN SIEGEL: If the members of the committee would please take their seats it would be 4

5 greatly appreciated. We are out of order, but we're on 6 report on subcommittee review of draft licensing modules.

7 Let me preface this with some background information.

8 You all will recall that at the last meeting, 9 we spent a fair amount of time talking about a number of 10 issues. The draft licensing modules-we really didn't have 11 time to go into in great depth. Consequently, we proposed 12 and the NRC accepted that we have a series'of subcommittee s 13 meetings to address the specific details in the draft {

14 licensing modules. A series of subcommittee meetings were held on September 27, 28 and 29 with kind of a rotating

~

15 16 cast of characters.

17 On the 27th -- I don't have the list in front 18 of me, but on the 27th in the morning, I and Lou Wagner 19 were there along with NRC staff to look at mobile medical 20 services. In the afternoon, I and Dennis Swanson were 21 there to look at radioactive drug therapy.

22 Then over the next two days, a group that 23 consisted of' Bob Quillin, Dr. Stitt, Dr. Flynn. Who did I l 24 forget from that group? Looked at a variety of radiation i

'\ 25 oncology related modules. ,

l NEAL R. GROSS count upoman me maeaamme 133 RMODE Imme Av5AE. N.W. ,

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-m 281

! 1 i When discussing how this was going to be I

g-~ 2 presented to the committee, I wasn't exactly sure how we 3 were going to handle this.

l So in discussions with Torre 4

over the last couple weeks, we decided that we would try 5 to put together some summary statements of what the major 6 changes, conclusions, recommendations were made by the 7 subcommittees, that I and Dr. Stitt would try to report 8 what the subcommittees did, in conjunction with the staff 9 person responsible for that particular module.

10 In addition, Trish has I guess overall 11 responsibility now for all of hte modules in coordinating

12 them. So she has an overall summary of major issues 13 involving hte licensing modules.

14 Now we can do this in varying degrees of 15 detail, depending on how we see fit. We can make these J 16 documents available for the record as part of the minutes 1

17 of the meeting. I can make the general comment that the 18 subcommittee met. They discussed the issues. We found a 19 number of important points that needed to be clarified 20 that related to just points that seemed ambiguous. I 21 think we made a number of valuable suggestions and 22 recommendations that the NRC I hope appreciates. I think i

23 overall, the discussions were useful.

24 Then why don't we, Trish, oh you're here. Why 25 don't we just briefly, and I mean quite briefly, go over NEAL R. GROSS couw nanomem me vnmemese SM RMoDE ELAND AVENUE, N.W.

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3) 282 1

your major issues, cummary statement. Let's just present 2 it in a couple of minutes.

7

?

[~~h Then we can just kind of

\~ / 3 quickly walk through each of them and. hit on what the big 4 issues are. We can scan them simultaneously. If any 5

people who are not at the subcommittee meetings have 6 specific questions, we'll try to address them.

l 7

My recollection is, is there anything that i

t 8 came out of the meetings that the conclusion was too '

9 controversial, needed to come to the committee for 10 resolution?

11 MS. HOLAHAN: No. I don't believe so.

12 CHAIRMAN SIEGEL: Good. Go ahead.

l 13 MS. HOLAHAN: Basical].y what we identified is 1

i 14 there were some issues that were across the board in all 15 modules, so we thought rather than going through repeating 16 them for each module, we could just sort of summarize 17 them. First of all, one of hte recommendations was that 18 we should ensure that all the modules should be consistent 19 where possible on such overlapping issues as training. We 20 made several modifications to the training for nurses, 21 training for ancillary staff, and training for physicists l

22 and other staff to be consistent amongst modules.

l 23 Also there was in general recommendations that 24 previously the authorized user training requirements were

\ 25 only up in the body, but in many cases, there was an l NEAL R. GROSS i

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(303 33 H ess WAAMesSTON. 0.C. 30005 (som 234433

283 1 indication that for authorized usero that were coming

(

~ 2 under the "or" category, there may be specific training in f

! \s 3 a modality in which they were going to be using, and so we \

i 4

should also include a discussion of the authorized user 5 training requirements within each module.

I 6 Another recommendation was that there should i 7 be comprehensive list of the records and retention 8 requirements for each module, or we may consider actually 9 having one overall list in the body of the front part of 10 the reg guide.

11 Currently, the only module that includes 12 standard license conditions is the remote after loading s 13 brachy therapy module. That was primarily because many of 14 hte issues that are not addressed directly in the 15 regulations. There are standard license conditions that

]

16 have been developed, so we felt that licensees should be !

17 aware of those standard license conditions.

18 I think following discussions on all the 19 modules, it was felt that we should actually include 20 standard license conditions that would be used for all 21 modules, and in fact, it's under discussion that we may 22 include also a reviewer checklist and a sample license, 23 that that could also be made available to licensees as 24 well as the license reviewers.

C 25 Also, and you heard this morning about the NEAL R. GROSS count nanomuns Aseinmooneens WB nM00s it.Afe AVENLE. N.W.

(304 3B H e38 WARMc4 TON. D.C. 30000 (Som 23H433 l

i 284 1 final patient relence rule. So there will ba

,-- 2 modifications as a result of the revised patient release 3 roll that will be made to primarily three modules, mobile 4 medical services, radioactive drug therapy, and manual 5 brachy therapy for permanent implants.

6 There was some discussion with regard to there 7 was a statement within several of the modules that once a 8 patient is released, the material is no longer -- the 9 licensee no longer has a direct regulatory responsibility 10 for the material. I think that's an issue that we 11 believe, and we have gone on record previously stating 12 that that is the case. Once a patient is released, it is

- 13 no longer licensed material.

\

14 I think there was some question as to whether 15 it was in conflict with part 20. But I don't believe our 16 review is to date that it does not appear to be in 17 conflict. ,

l 18 Also the modules, this is a minor thing, are l l

l 19 not consistent. We can make sure that they are all l 20 numbered consistently.

21 There.was also a discussion in several of 22 these subcommittee meetings as to whether the appendices 23 should be revised at this point in time. Well, as Dr.

24 Cool mentioned this morning, is much of this is going to

\ 25 be tied in with the overall BPR cfforts in the licensing NEAL R. GROSS count nanomes me nwecasse 1m3 FM00E WLAND AVENUE. N.W.

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285 1 process. I think we will not updnte the appendices at f-', 2 this point in time but that will be done as part of the 3 BPR manual.

4 The other issue that we'll review as we go 5 through the finalization of these modules is look again at 6 what is in 10.8. I think some of the modules contain more 7 details that are repeated in the body. We need to make 8 sure again that it's not confusing between flipping back 9 and forth between the module and the body. So we need to 10 make sure that the appropriate references are in place.

11 Finally, a question was raised that modules 12 that are affected by the QM rule we should include 13 specific guidance addressing the QM rule. A decision was 7 -)

14 made that what we will do is make sure that the i 15 appropriate references to Reg Guide 8.33 are included in 16 there. Again, any modifications will be included in the 17 BPR process,. and then again following a major revision of j 18 part 35, we would look at 8.33 again.

19 CHAIRMAN SIEGEL: Okay, good.

20 MS. HOLAHAN: So that's pretty much my 21 summary.

22 CHAIRMAN SIEGEL: Any questions about that, 23 general comments? Big fabric issues? Okay good.

24 So the first one that was discussed on

's 25 Wednesday morning was mobile medical services. Torre, do NEAL R. GROSS count narontens ue mageneens 1303 nH00m ISLAND AVENUs, N.W.

(300 3364433 WASHINGTON, D.C. 3000$ (300 2344433

f ""G 286 j 1 you want to do it? Do you want m2 to do it? Okay.

! -- 2 That's fine.

# 3 This was a I thought a very interesting 4 discussion. We got some very interesting items on the 5 table. I think the key thing we recognized is that the 6 . scope of mobile medical services is in evolution and it's l 7 not clear exactly how things are going to change with 8 time. So part of what is in this regulatory guide needs l

9 to be a little bit flexible. I'm sure it will be.

10 We suggested that as we just heard, that the l

11 language be adjusted with respect to patient release rule.

12 There was considerable discussion about including some

! N 13 point in the document, I'm not sure we knew exactly what 14 needed to be in there about reciprocity with state l

15 licensing where the mobile medical services crossed state 16 lines, and some guidance needed to be in there about how 17 to address that.

18 I'm trying to remember what item three was. I 19 expressed the concern that the regulatory criteria did not 20 reflect the current trends. Torre, refresh my memory.

i l 21 MS. TAYLOR: Yes. That was in line with what i

22 you just said about the scope of services changing and the l l 23 new modalities.

f- 24 CHAIRMAN SIEGEL: So this is just an i

x 25 observation?

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i 287 1 MS. TAYLOR: Yes. Just an observation.

Something that we can do in the guide.

2 3 CHAIRMAN SIEGEL: The single most important 4 thing we did during the morning session was we killed the 5 term called medical non-institution, which is not a term, 6

and substituted instead the term non-institutional medical 7 practice. I consider that, frankly, to be a triumph of 8 the English language for bureaucratese. I hope it is 9 accepted.

10 Considerable discussion about the potential 11 conflicts that could occur between the mobile service i

12 contractor and the client, on the one hand, or between the 13 mobile service provider and the landlord, in those 14 circumstances where mobile services are actually provided 15 out of a residence. The bottom line on that was that the 16 NRC needs to as part of the licensing process, get clearer ]

17 understanding about the nature of the agreement between 18 the provider, the contractor on the one hand, and the 19 client. Some interesting discussions about scenarios that 20 I think are pretty unlikely, but one has to plan for 21 contingencias.

22 The document needs a description of the 23 special problems associated with overseeing radiation 24 safety programs in mobile services, since the authorized 25 user in the RSO is not likely to be on site all of hte NEAL R. GROSS couw neomuns um nwemeens 1333 nM00E SLAND AVENLE, N.W.

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i

! 288 1 tima. That also goso to the issue of what constitutes I 7s 2 adequate supervision of supervised individuals. The guide

\'-,) 3 suggested as often as every 30 days review of individuals 4 work. We questioned whether 30 days was a reasonable 5 frequency. We didn't really come up with a correct answer 6 because it would depend on the nature of the mobile 7 service itself.

8 We also questioned the current statement that 9 the authorized user or RSO be able to respond to the l

j 10 incident within three hours. Respond in this case means 11 physically present, because there are certain mob'lei i

12 services in rural areas that cover very wide territories rs 13 where that could be a problem, and where the nature of the '

14 potential accidents wouldn't warrant such rapid response.

15 So there's some wiggle room on that, seemed to be required

! 16 as well.

l 17 Any comments? Torre, you want to add 18 anything?

19 MS. TAYLOR: No.

20 CHAIRMAN SIEGEL: Okay. Radioactive drug 21 therapy.

22 MEMBER STITT: Dr. Siegel, I had a question.

23 CHAIRMAN SIEGEL: Please.

~s 24 MEMBER STITT: A clarification. It would

\ 25 never be the case that the mobile HDR units would be NEAL R. GROSS coum upoems um ruecneEm taas RM00E IRAND AVENUE N.W.

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9 289 1 looked at en mobile msdical service.

2 CHAIRMAN SIEGEL: Currently a mobile medical 3 service is only authorized for diagnostic imaging.

4 Exemptions could be granted for radioactive drug therapy. l 5 You have granted some, is that correct, in the past in 6 mobile services?

7 MR. CAMPER: Mobile? Yes. We have.

8 CHAIRMAN SIEGEL: We are told that the State 9 of California either has an application or has licensed 10 mobile HDR.

11 MR CAMPER: The State of California has 12 licensed. We anticipate receiving an application for a 13 license.

14 MEMBER STITT: Would that be regarded under 15 the mobile or do we look at that under ---

16 MR. CAMPER: No. That would be --

17 MEMBER STITT: It doesn't really fit.

18 MR. CAMPER: The guidance document here does l l

19 not address mobile HDR.

20 CHAIRMAN SIEGEL: It addresses mobile service l

21 as currently defined in part 35, which is limited to l

22 35.100 and 35.200 applications. Correct? l 23 MR. CAMPER: Also if we do end up licensing 24 the mobile HDR, that would require an exception to the 25 regulations because currently it's not addressed in the NEAL R. GROSS cous nEmmme ANo wNemeEns 1MB nMODE ELAND AVENUE. N.W. ;

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290 1 regulations.

2 CHAIRMAN SIEGEL: Okay. Radioactive drug a 3 therapy. I should point out that at this session, Mark 4 Ratman, per invitation, joined the discussion and made 5 many useful contributions. Key points. Documents are 6 referenced alpha and beta emitters over and over. We 7 basically said that really the key issue was the safety 8 considerations associated with the proposed radioactive 9 drug therapy program and you didn't need to single out j 10 alpha and beta emitters. You just need to have the ;

i 11 licensee lay out what they plan to do and how they plan to 12 address the safety issues.

eN 13 There was a point about need to deal with 14 released patients in the module. We basically said that 15 when they are released, they are released, and the 16 licensee no longer has radiation safety responsibility for 17 those patients.

18 There was a word in there about licensee staff 19 being able to understand isotope burden to the patient.

20 we said that needed to be out. Requirement for including 21 information on staffing levels was recommended it be 22 removed as not being really something NRC was supposed to 23 be looking into. Rather, it was how the program was laid 24 out.

\'. 25 I'll let you look at five yourself. It is NEAL R. GROSS oOum assomuns um mNecnese 1MS RMODE IE#e AVENLE, N.W.

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7 291 1 straight forward.

g- 2 There was a long list of training k 3 requirements. There was a list for nurses. There was a 4 list for other people, professional staff involved in the 5 therapy. Then there was a list for ancillary staff, like 6 housekeeping staff. We basically suggested that those 7 first two lists be collapsed into a common list. A 8 training program for staff involved in the administration, 9 monitoring and care of patients undergoing radioactive 10 drug therapy, and that the training for those individuals, 11 depending on their specific nature, should be commensurate '

12 with the individual's duties. So that gives licensees 13 room to design their programs as they see fit.

\

14 overlap issue was discussed. Item nine. Oh I 15 see, we just made a redefinition of a term. We decided 16 the dose calibrater and dose measurement were going to be 17 made consistent with the radiopharmacy guide.

18 Dennis, you want to add anything? Bob, do you 19 want to add anything there in the back there?

20 Okay. Now this is when I no longer was 21 around. Dr. Stitt became the chairman. Manual brachy 22 therapy. Do you want'to do it or you want Dot to do it?

23 Your choice. Manual brachy therapy. Do you want to

-, 24 summarize it? Who did manual brachy therapy, staff

\~ / 25 person. Oh Trish, I'm sorry. Well I'm confused.

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292 1 MEMBER STITT: We were just conferring. I 2 will do it. We were actually conferring on what went O~ 3 between these two, which is --

4 CHAIRMAN SIEGEL: Was there one for HDR? !

5 MEMBER STITT: Right. That's what we were --

6 let me start with remote afterloading. You don't have a 7 page for remote afterloading.

8 CHAIRMAN SIEGEL: Okay.

9 MEMBER STITT: But HDR falls into -- most of 10 the discussion really revolved around issues that we in 11 this full committee have been discussing now for a year 12 and a half, almost two years. It has been high on all of

, 13 our agenda on a regular basis. So that there was nothing 14 that was alarming or new or unusual. In fact, we is basically verified that a lot of what we have been 16 discussing as a committee will now show up in that format.

17 I think one of hte issues that Trish and I i

18 were just reviewing also had to do with reciprocity, state' i

19 licensure, and the different vendors of the different HDR 20 units. That was brought up and we put out on the table as 21 an issue much like you were discussing that in radioactive 22 drug therapy or mobile.

23 I'll stop there on remote, unless there are 24 any other questions or comments. Trish, would you like to 25 make any additions or better --

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i 293 1 MR. AYRES: Bob Ayres with the staff. The 2 reason there's no sheet is I felt as Dr. Stitt said, we O 3 have been over this many times and our subcommittee never 4 came up with any major issues that I thought needed to 5 come to the committee. The issue of reciprocity was just 6 going to be a short note to the licensees that maybe they 7 should check on it, because it is the service vendor's l

l 8 responsibility in this case to obtain the reciprocity.

9 It's not the licensee's responsibility, but we thought a 10 little note would maybe help jog people's memory.

11 I think the general comment, the subcommittee j 12 went great. I got a lot of really useful and valuable 13 comments. I think a good part of the valuable i\

14 contribution is we did a lot of work in that committee 15 meeting in bringing this module'into line with many of hte i 16 comments from previous subcommittee meetings the day 17 before Trish provided input, in bringing these ancillary 1

18 personnel, nurses training. In that meeting, we started 19 to standardize the modules.

20 MEMBER STITT: Professor Quillin gets the 21 Queen's English prize. He read every single word, all the l 22 colons and the sub-phrases and clauses, and has this in a 23 very readable form.

24 MR. CAMPER: One comment I would make about

( 25 hte remote afterloading discussion. There was a fair NEAL R. GROSS coum nerommu neinmemmEns 13EB nN00E mLAND AVsNut. N.W.

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7 294 1 amount of tima that was devoted to discussion, the 2 qualifications, training experience for physicists. We 3 discussed at great length what we currently do in our 4 guidance, in policy and guidance directive FC 86-4, which 5 was updated substantially following the incident in )

6 Indiana, Pennsylvania.

7 Now we are looking for turning an experience 8 currently for a physicist associated with high dose rate 9 mode afterloading similar to what is currently specified l 10 in our regulations for teletherapy, except of course we 11 are looking to see experience that is specific to the use 12 of HDRs.

13 Now I think the important thing beyond that

14 point is that it was recognized by the subcommittee that i

r is ultimately when we look at a revision part 35, we should l 16 be discussing at great length this whole issue about l l 17 medical physicists. What's the best term to be used, l l 18 should physicists be expected to have a document ,

I I

i 19 experience that is germane to the particular modality, be i 20 it teletherapy or HDR or gamma stereotactic radiosurgery 21 and so forth and so on.

l 22 But that's not something that the subcommittee 23 needed to take on or that we would take on at this point. j 24 But just be aware that at some point again, this physics 25 T&E issue is something we'll have to work our way through.

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~7 295 1 But for the tima being, clearly for HDR wa are expecting s 2 to see physicists, demonstrated experience with HDRs, and 3

an overall T&E similar to what is going on for teletherapy 4 physicists, because all we define in our regulations 5 currently is a teletherapy physicist.

6 MEMBER STITT: To move on to the manual brachy 7 therapy module. You also have a handout on that. I don't 8 think we need to read through them necessarily, but Dr. i 9 Flynn had a number of comments that he brought up and we l

10 discussed at great length, in addition to Dr. Quillin's 11 grammar comments. You can read issues of shielding, 12 record keeping, and survey procedures.

13 Questions or comments on the manual module?

14 Again, as Trish brought up earlier, everything has been 15 brought into line search. It will be easy to refer from 16 one section to the next. The format will be the same.

17 Dr. Quillin is going to discuss the gamma 18 knife fertility therapy module.

19 MEMBER QUILLIN: Well, I wasn't here for the l

, 20 teletherapy module, but I was here for the gamma knife 21 module. There was a comment --

l 22 MEMBER BROWN: I thought you were going to 23 say, but I'll discuss it anyway.

24 MEMBER QUILLIN: There was one comment I had 25 that went throughout the brachy therapy and the gamma l NEAL R. GROSS cous neomas me nwoo0nsas 1303 nMODE WLAND AVENUE, N.W.

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7 296 1 knife module. That was the laundry list of subjects that 2 other staff were supposed to be instructed in.

\

3 We looked at those other subjects at some 4 length and deleted some. I think in at least one case, 5 added one, and clarified some because the subjects were 6 generic in nature, but were not really clear as to the 7 meaning as far as the presentation was concerned. For 8 example, one of the items that was in the subjects as I 9 remember was radiation signs. I think we made the 10 recommendation that we listed down there as the meaning of 11 radiation signs. That we weren't supposed to be, training 12 people in how to put up radiation signs necessarily, but 13 what the signs meant to staff.

\'-

14 In the gamma knife module, I think the items 15 here are reasonably self explanatory. Some of the things 16 that we spent more time on than others were the 17 qualifications for the physician and physicists, what type is of qualifications and training, experience would be 19 expected and what were the roles of the physician and 20 physicist during these procedures, j 21 Right now the document as written as presented 22 to us was somewhat vague in that matter. We felt that 23 that should be more explicit, and also should be 24 consistent in form and format with the other documents, b

\,s 25 Another issue that we talked about, and I'm NEAL R. GROSS count neomEns ue TwecamEns 1333 RMODE mLAND AVENUE. N.W.

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297 1 not sure it's presented clearly here, is page 226 on the 2 worst case scenario for doing radiation surveys. We 3 didn't recommend that you do a worst case scenario, but 4 basically what I would call a realistic case scenario for 5 the survey. That was based upon realistic work load 6 criteria use and occupancy. The document was presented to 7 us, assume that you did all of the cases in one day within 8 one hour's time period. In other words, if you were going 9 to be treating five people, you treated them all in one 10 hour time frame, which we didn't feel was a realistic 11 situation.

12 There was an issue on the intercom. We had g 13 some discussions. We felt that the need for an intercom, i

\ 14 which was not included in the guide, should be included 15 because of hte need to be able to communicate with the 16 patient during the procedure.

17 So those were the main things as I remember, 18 from the gammk knife module. Any questions?

19 MEMBER WAGNER: Can I go back one? I just 20 wanted to ask one question.

21 CHAIRMAN SIEGEL: On manual brachy therapy?

22 MEMBER WAGNER: Yes. It's under area survey 23 procedures, consider including a recommendation to post a 24 record of the survey. Is that for someone in particular's V 25 information or just a document that the survey had been NEAL R. GROSS count nEpomas Ano inan0camEas 1M3 aMODE 80LAfC AVENUE, N.W.

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[ _ . _ _ _ _ _ - _ _ _ _ _ _ _ _ _ - _ _ _

298 1 done.

2 MEMBER QUILLIN: It was for information 3 purposes so individuals entering the room could see what 4 the resulte were.

5 MEMBER WAGNER: And what individuals are you 6 thinking of? Who would understand what that means?

7 MEMBER QUILLIN: An authorized user, for 8 example.

9 MEMBER WAGNER: Okay. So it is for hte 10 physicists or other physicists? If you had two or more 11 phycicists, maybe one goes up, sees it was done, he could 12 read what the number was.

13 MEMBER. QUILLIN: Or for the authorized user to 14 know what hte numbers were, to be able to use that 15 information if a question arose.

16 MEMBER WAGNER: Okay.

I 17 CHAIRMAN SIEGEL: Okay. Any other questions 18 or comments on the gamma knife stuff? Jim Smith will give 19 us a short presentation about what happened to 20 teletherapy. Part of this rotating musical committee 21 members game, Dan Flynn took over the chair at that point l 22 of that subcommittee meeting, but Dan as you know is not l

l 23 here because someone else is in labor. I don't understand l 24 that totally, but that's okay.

25 MEMBER WAGNER: His partner's wife I think is l

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299 1 having b by co ha hed to cover the practica.

2 MR. SMITH: We didn't have a whole lot of 3 comments on the teletherapy. Basically, the first item is 4 the same as from the gamma knife module basically, because 5 we just covered that under the gamma knife.

6 Dr. Flynn felt that if we needed an intercom

~

7 for a gamma knife, we also needed intercom requirement 8' under teletherapy.

9 The other was sort of a recommendation that we 10 could recommend to our licensees that they post action 11 levels in the form of normal treatment parameters so that 12; technologists or therapists conducting these treatments 13 for the teletherapy unit would know when something was out 14 of the ordinary. That was about the entire gist of the 15 main items.,

16 CHAIRMAN SIEGEL: Good. Thank you.

17 Questions? Comments?

18 MEMBER BROWN: There was just a discussion 19 that this guidance document was created or revised last in 20 1985. So we felt there was a need to update it. However, 21 we recognize that it appears that the use of teletherapy 22 is falling off in the United States. We talked about that 23 a bit, but still felt that updating the guidance at this 24 point in time was important.

25 MEMBER QUILLIN: I just have one final NEAL R. GROSS cous manwe me ww.cneEm 13e RMODE IEAND AVENUE, N.W.

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300 1 comm2nt. Savoral comments ware mada about my grammar 2 review. I do like subjects and verbs in sentences.

3 MEMBER STITT: You kept complaining about 4 that. He kept finding all these sentences that had no 5 verbs.

6 CHAIRMAN SIEGEL: Picky picky picky.

7 MEMBER BERMAN: I'd just like to comment on 8 your part that on page 192, what you meant when you said 9 that the physician and physicist should be physical dur:ng 10 the GSR treatment.

11 CHAIRMAN SIEGEL: We said that cardiologists 12 had no sense of humor. Okay thank you. Thanks to 13 everyone for their hard work on this.

14 Having done now a couple of these types of 15 things with you, I am really convinced that when it comes 16 time to roll up sleeves, look at a document, and think 17 through a process in great careful detail, that a group of 18 three or four people in a room gets a lot further than a 19 group of 13 people, being afraid what they are saying in i

20 the microphone. So some of these working sessions really 21 are quite effective, and I encourage you to keep having 22 them as issues arise that need them.

23 The last item of the day is status report on 24 the National Academy of Sciences study of the medical use i 25 program. Pat. She had to leave. I think we actually l NEAL R. GROSS l

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GIS33M4B WASHINGro% 0.C. 30005 (30E) 23ussa

301 1 heard part of this from Dr. Papariello.

2 frs Let's see. So I am going to give Pat's 3 report. The National Academy of Science's report to the 4

NAS peer review process apparently occurred on August 25, i 5 1995. The document is not out yet. When approved by peer 6 review, Carl Paperiello and Pat Rathbun will read it. Ten 7 days later, they will get a confidential copy.

8 I need to get some clarification, because I 9 actually had a conversation with Kate Gottfried a couple 10 of months ago and was led to believe that members of the 11 advisory committee might actually be able to see copies 12 sometime in November.

-s 13 So that sounds like the January date is one

's 2 14 date that you all are hearing. She seemed to think this 15 document would be done and on its way to the printer in I i

i 16 early November.

17 MEMBER BROWN: I have never heard that l 18 comment.

19 CHAIRMAN SIEGEL: If I get a copy, I'll give 20 it to you.

21 MR. CAMPER: Would you please do that, because 22 we'd like to have it.

23 CHAIRMAN SIEGEL: Not until I have analyzed it 24 very carefully.

O (s,/ 25 MEMBER BROWN: There has been some -- what has NEAL R. GROSS cover nacomas mo mmAcneans tags RN00E IAUND AVENUE N W.

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l' 302 1

caunod confucion in all of this, and that is, is that m:ny 7-t 2 of you probably are aware that the NAS has a process of

\ 3 how it goes about doing business. It is unusual I think 4 that a copy of their reports are provided to the entity 5 which requested that they develop them before they are 6 actually and formally published t..d released.

7 However, in this case, you might recall that 8 there was a briefing by the NAS to the commission, during 9 which then Chairman Selin expressed a great deal of 10 interest in the commission receiving a copy of hte report 11 once it had undergone peer review and was on route to 12 being published.

r-'s 13 As a follow up to that, there was apparently

(

14 some telephone discussion between the Institute of 15 Medicine at NIS and the chairman or the chairman's office.

16 Ultimately, a letter was sent from the chairman to IOM, as 17 sort of a follow-up to that conversation in essence 18 thanking them for making a copy of that available to us.

19 Now we have had some ongoing discussions 20 amongst ourselves and with the EDO's office, that we try >

1 21 to plan to receive this and process it. There has been 22 some confusion as to just what was going to be.

23 In my understanding of it within the last day 24 or two, in fact talking to Pat, is that once it is

,i

(

25 available or it is completed, it's undergone peer review.

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303 1

Carl PEpariollo cnd Pat Rathbun will have tha opportunity f 2 to read it. That within 10 days, we will receive a 3 confidential copy of it. That is our current working 4 understanding.

f 5 Contractually, they are obligated to provide 6 us with a report on or about 5 January of 1996. So at 7 this point in time, I think it is fair to say that we 8 anticipate seeing a copy of it and we'll have a chance to 9 look at it confidentially some time I would assume in 10 November I would think.

11 CHAIRMAN SIEGEL: One concern I have is that 12 if we are planning on meeting on February 21, 22, and now 13 maybe an additional day even added on for training,

% 14 experience, and that meeting is going to include an 15 analysis of the document and the commission briefing by 16 this committee, that --

17 MR. CAMPER: We have a couple issues there.

18 Let's think that through.

19 CHAIRMAN SIEGEL: That's going to be quite a

20 challenge.

I 21 MR. CAMPER: Our plan is not to provide it to 22 the committee until we have the document and it is i

23 available for public dissemination. We have not discussed 24 or given any consideration to, nor I'm sure that we could

( 25 frankly. If we are provided with a copy at all, and if l NEAL R. GROSS I

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304 1 it's confidential, that wa could provida it to the 2 committee.

.O 3 CHAIRMAN SIEGEL: Right. I understand that.

4 MR. CAMPER: So our plan has been to get it to 5 the committee as promptly as possible once it is 6 published. The meeting on the 21st and 22nd was a meeting 7 that was designed to discuss the NAS report and the 8 staff's analysis as it exists at that time of hte report.

9 I don't think that we had actually considered, but we 10 certainly could, whether or not that two-day session on 11 the 21st and 22nd of February would also include a 12 briefing of the commission by the committee. You may or p 13 may not be prepared to do that at that point.

14 CHAIRMAN SIEGEL: I am not certain we would 15 be. Do you all not have a commission briefing scheduled 16 for that time frame?

17 MR. CAMPER: Well, what we intend -- I was 18 going to go ahead. What our thoughts were was we have hte 19 working session on 21, 22 February. Consistent with our 20 earlier discussion today, possibly we would add a third 21 day onto do the first work on the T&E stuff.

22 We are currently scheduled to brief the 23 commission the last week of March. That would be our 24 annual briefing to the commission on the medical use

\ 25 program. Of course obviously this year it is going to be NEAL R. GROSS cQue mecomus me nwomene taas RN00E ELAND AVENUE, N.W.

WASNINGTON, D.C. 3000$ (200 2M4433 (314 IH 4433

305 1 all about tha staff's reaction to and so forth and so on, 2 to the NAS.

3 We had planned, Barry, as part of that to dial 4 in the ACMUI to participate in that briefing in a fashion 5 as we have previously. Now that could either be a 6 situation where you would represent the committee or 7 select members of the committee could represent, or even a the committee as a whole for that matter. But that is

.9 something we have to talk about.

10 CHAIRMAN SIEGEL: Okay. I misunderstood.

11 That's fine. We'll have plenty to do in February just to 12 talk about hte do'cument. If we take on this training 13 stuff, we could meet for days on end.

14 MR. CAMPER: Yes. That's my guess. I doubt 15 if the committee really would be prepared to brief. But 16 we certainly have to make sure that that opportunity 17 exists, whether it's with our annual briefing or even a 18 stand-alone briefing.

19 CHAIRMAN SIEGEL: All right. We have one 20 remaining order of business for today, unless anybody else 21 has. business that.I'm not aware of. That is, we have to 22 figure out what time we are starting tomorrow.

23 The Fadaral Racister notice says the meeting 24 starts at 8:30. The agenda shows a closed session from 25 8:30 to 9:30. The closed session was not noticed in the NEAL R. GROSS coum nummune me t- -

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306 1 Federal Recister, thorofore we could start at 8:30 or if 2 it's our pleasure, we could start at 9:30. I talked first V 3 with Larry and subsequently with Torre. I think the 4

conclusion that Torre and I have reached is that we have 5 wiggle room on that. We could go either way. So what is 6 the committee's pleasure? An extra hour of sleep?

7 MEMBER QUILLIN: 8:30.

8 CHAIRMAN SIEGEL: Versus getting out of here 9 sooner.

10 MEMBER WAGNER: 8:30.

11 MR. CAMPER: Well, the only concern I have 12 about 8:30, and I understand why --

p 13 CHAIRMAN SIEGEL: Is the presenters may not be 14 here.

15 MR. CAMPER: Well not only that. Well that 16 and if anyone was here today who intends to come tomorrow 17 and they saw the agenda, they would not come at 8:30 18 because of the closed session. They would show up at 19 9:30.

20 CHAIRMAN SIEGEL: So I'm actually inclined --

21 I don't think we are going to go over tomorrow's planned 22 agenda. I know it's not going to go too late because I 23 have to give a lecture at the Naval Hospital tomorrow 24 afternoon and I plan to be there. So I think we probably n'd 25 need to opt for 9:30 as a start. Then we'll still plan to NEAL R. GROSS couw neromuRs meinmoonmen 1333 RMODE WLAND AVENUE, N.W.

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307 1 gat out of hora on tims or ahoed of achtdule.

2 MEMBER QUILLIN: If we say 9:00, we may start 3 at 9:30.

4 CHAIRMAN SIEGEL: No. We started this morning 5 only a couple minutes late. Do you have an earlier plane 6 you would like to catch? That's okay if you do. I 7 suppose we could start at 9:15 and deal with 8 administrative matters.

9 MS. TAYLOR: Dr. Siegel, the other option, we 10 could do the industrial issues -- (inaudible) --

l

)

11 MR. CAMPER: I suspect that members of the 12 public would be here by 9:15. So we can go in that p 13 window, that 9:15 to 9:30 window. '

14 CHAIRMAN SIEGEL: All right. Let's plan on 15 starting at 9:15 tomorrow. So everybody gets a slightly 16 more relaxed breakfast tomorrow. Then we can start with l l

17 the regular agenda in all likelihood. We are closed for 18 today.

l 19 (Whereupon, at 4:38 p.m. the proceedings went l 20 off the record.) l 21 I

22. i 23 )

24 p

25 NEAL R. GROSS coue nsmmuns mo nweeneens m3 nM00E M.AND AVENLE, N.W, (SIN) 396443 WAAMNSTON.D.C.30W (SIN) 3344433

CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory Commission in the matter of:

Name of Proceeding: A/C ON MEDICAL USES OF ISOTOPOES '

Docket Number: N/A Place of Proceeding: ROCKVILLE, MARYIAND were held as herein appears, and that this is the original '

transcript thereof for the file of the United States Nuclear

{

Regulatory Commission taken by me and, thereafter reduced to f typewriting by me or under the directio'n of the court reporting company, and that the transcript is a true and

( accurate record of the foregoing proceedings.

CORBETT RINER Official Reporter Neal R. Gross and Co., Inc.

i O NEAL R. GROSS coum neomuns ANo mNeaumes tan MMODE SLAND AVENUE, N.W.

(344 336443 WASMINGTON, D.C. 335 (3G2) 2364633

ML20216D128

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