ML20056H177

Revised Transcript of 930729 Briefing in Rockville,Md Re Options for Changes to Regulation of Nuclear Medicine.Title Corrected.Pp 1-80.Supporting Documentation Encl

ML20056H177
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Issue date:	07/29/1993
From:	NRC COMMISSION (OCM)
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REF-10CFR9.7 NUDOCS 9309080334
Download: ML20056H177 (103)

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l l DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on i. 24, 1993-in -he Commission's office at One White Flint North, Rockville, Maryland. The meeting was open to public attendance and observation. This transcript i j has not been reviewed, corrected or edited, and it may I contain inaccuracies. d l 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 determinacion or beliefs. No pleading or other paper may be filed with the Commission in any proceeding ' as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize. i HEAL R. GROS $ i CoUtf Ripotift$ AHO TRANSCR!tfR$ 1313 kHoot t$tAHO AYtWUt, N.W. (202) 234-Am WA$HMOToH, 04 20005 m2) M24600

I ~ 1 -l J UNITED STATES OF AMERICA 1 NUCLEAR REGULATORY COMMISSION l i i l BRIEFING ON OPTIONS FOR CHANGES TO l REGULATION OF NUCLEAR MEDICINE 1 i t PUBLIC MEETING i I l .i Nuclear Regulatory Commission One White Flint North Rockville, Maryland Thursday, July 29, 1993 The Commission met in open

session, f

pursuant to

notice, at 10:00 a.m.,

Ivan Selin, Chairman, presiding. r i COMMISSIONERS PRESENT: l f h IVAN SELIN, Chairman of the Commission f 4 KENNETH C. ROGERS, Commissioner FORREST J. REMICK, Commissioner E. GAIL de PLANQUE, Commissioner j i i 4 NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS T323 RHODE ISLAND AVENUE, N W. l (202) 2"4-4433 WASHINGTON D C. 20005 (202) 2344 433 J i e. v.

- - - ~. _ 2 STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE: SAMUEL J. CHILK, Secretary [ i i WILLIAM C. PARLER, General Counsel JAMES TAYLOR, Executive Director for Operations RICHARD VOLLMER, Director, Office of Policy Planning f CHARLES NORELIUS, Region III JOSEPHINE PICCONE, Senior Program Manager, Medical and Academic Section JOHN TELFORD, Regulation Development Branch, NRR i l DON HAMILTON, Food and Drug Administration l LLOYD BOLLING, Health Physicist, Office of State Programs i t i i c ? f h i k 1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS O23 RHODE ISLAND AVENUE, N W 4202) 234 4 433 WASH:NGTON. D C 20005 (202) 2344433 r

= - -. I 3 .t j 1 P-R-O-C-E-E-D-I-N-G-S 1 i 2 10:00 a.m. I r 3 CHAIRMAN _SELIN: Good morning, ladies _ and ? q ) 4 gentlemen. i i 5 i The Commission is meeting at this time to -l 6 !l receive a briefing from the NRC staff and the non-NRC l i 7 members of the task force concerning the.Very { 8, important subject of options for the regulation of the >l 9 medical use of radiation in this country. + t 10 On May 6th of this year the Commission 11 testified on the subject before the Senate Committee l 12 on Government Af fairs, Chaired by Senator Glenn. Part t 13 i of our testimony discussed the current situation with 14 l regard to the distribution of responsibility 'or i 15 regulating radiation medicine.

Now, radiation i

16 medicine is a phrase which basically doesn't mean i 17 nuclear medicine and it doesn't mean radiation .l 18 therapy. I'm not exactly sure what it does mean, but 19 it's designed not to get us a letter from the American { l 20 l College of Physicians. j 21 The fact that materials regulated under l 22 l the Atomic Energy Act and therefore subject to control f I i 23 l either by the NRC or by one of our 29 agreement states i 24 are used in only about a quarter of the cancer therapy. i 25 1 treatments. Electronically generated radiation i. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. i (202) 234 4433 WASHINGTON. D C 20005 (202) 2344433 I

i I 4 I i 1 ij produced mostly by linear accelerators is used for the 2 other 75 percent of therapy treatments and is not 3 ! subject to regulation or control under the Atomic ) 4 Energy Act. This radiation is regulated at the user if 5 ;j level by the individual states without involvement of ll the federal government and the distinction is the 6 l. i 7 ! responsibility of the federal government for devices l 8 and for the handling of sources, but the key emphasis j today is on the application of radiation in medicine 9 i 10 j and what regulation ought to be done at the federal ,+ level. i 11 li 12 i Because of the disparity between the i 13 really pervasive federal regulation of radiation 14 medicine from AEA sources as opposed to the device-15 oriented regulation from other sources and for a 16 number of other reasons our testimony touched on what 17 appeared to be some of the fundamental options for 18 instilling a higher degree of uniformity in our 19 national regulatory scheme. We also promised Senator 20 Glenn that we would prepare a pre 1iminary report I l 21 examining these options and provide it to him by this l 22 coming August 6th, three months after the hearing. 1 23 L At this

point, the task force has 24 completed its work in conducting a preliminary review 25 of the available options to the regulation of the NEAL R. GROSS i

COURT REPORTERS AND TRANSCRIBERS 1223 RHODE ISLAND AVENUE. N W j .202) 234-4433 WASHINGTON D C 20005 (2C2) 234-4433 ~...

5 i 1 medical use of - radiation and has prepared a report l 2 documenting its efforts and results. It is this { 3 report that is the subject of this meeting and the. r 4 Commission is, to say the least, very interested in 5 what the staff and the task force has found in its 3 6 inquiry into the area. t 7 Copies of the staff's report are available .i 8 at the entrances to the meeting room. .j I 9 Commissioners, are there -- j 10 COMMISSIONER de PLANQUE: No. l 11 CHAIRMAN SELIN: Mr. Taylor, please. 12 MR. TAYLOR: Good morning. Mr. Vollmer 13 will give the presentation and introduce the members 14 of the task force. I would note that this report was 15 put together in a period of slightly in excess of two 16 months and that in my view it begins to frame the j l 17 issues but doesn't -- and lays the groundwork for what 18 could be future work by OPP and the staf f, the rest of. I 19 the staff with regard to actions resulting from this. l l 20 report. { i 1 21 With those thoughts, I'll ask Dick Vollmer 22 to begin the briefing. 23 MR. VOLLMER: Thank you. 24 Mr. Chairman, Commissioners, this mornir.g 25 we would like to brief the Commission on the results .NEAL R. GROSS COURT HEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202)2344433 WASHINGTON. D C. 20005 (202) 234 4433

I l ^<. 6 l 1 of a task force effort and our report on medical l l 2 radiation protection. 3 First I'd like to introduce the members of 4 the task force to you. From your left, Jchn Telford i 5 from the Office of Research. Next to me, Josephine i i 6 Piccone from NMSS. On the other side of Mr. Taylor s 7 are Chuck Norelius of Region III. Next to him is Don 8 Hamilton from the Center for Devices and Radiological s 9 Health in FDA. 10 I might indicate that when we were first Il given this assignment I not with Doctor Burlington who 12 testified also at the May 6th hearing, who is Director 13 of the Center for Devices and Radiological Health, 14 Rosenstein and Don to enlist their aid in the task 15 force effort. As a result of that meeting, Don became 16 a member of the task force to provide the FDA 17 perspective and to assure that FDA's role in the 18 medical uses of radiation was properly presented or ~ 19 represented. [ l 20 Also, next to Don is Lloyd Bolling of the 21 Office of State Programs. 22 Not at the table are Maria Schwartz, 23 office of General Counsel, in back of Mr. Parler, and 24 Janet Lambert and Darrel Nash of my staff are sitting f 25 behind us. l NEAL R. GROSS { COURT REPORTERS AND TRANSCRIBERS 1323 Rr40DE ISLAND AVENUE. N W j (202) 234-4433 W ASHINGTON, D C. 20005 (202) 234 4433 l

i 7 i 1 All these people provided strong support 2 to the task force effort and will be able to respond 3 to the Commission's questions. We also receive strong support from the l 4 5 program offices. 6 (Slide) I'd like to turn now to slide 1 I l 7 and provide a brief background on how we got where we 8 are today. 9 As the Chairman indicated, the May 6th j I Glenn hearing in which the Commission testified, he l 10 ) 11 requested the Commission's advice on how the i 12 regulation of all sources of medical radiation might ( 13 be done better and the Chairman agreed to provide a 14 preliminary report in three months. and this task force 15 effort is the culmination of that activity. 16 As you had indicated, Mr. Chairman, this i l 17 review of ours was not to be limited to sources of 18 ionizing radiation strictly.under NRC's purview, but { 19 we were to look at all sources and take a look at the i 20 best federal envelope or federal / state envelope for I 21 handling that particular activity. 22 On May 17th the EDO provided a plan of t i i 23 action to the Commission in which he established the l 24 task force and indicated several options for change' I 25 that should be considered by the task force. We NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. G02) 2344433 WASHINGTON D C. 20005. (202) 2344433 l J

t l ) 8 - l 5 l proceeded then to develop and get a stakeholder's 1 i 2 input on the plans, on our plans to evaluate those 3 l options. The first effort in that regard was on May t I, 4 20th when I met with most of the state representatives i

l i

li 5 at a public meeting which was chaired by State j c 6 l Programs, a meeting which followed the annual meeting t 7 i of the Conference of Radiation Control Program l Directors. I got their views on a transcribed basis 8 l 9 l; to the options that were suggested in the EDo's memo' lI i i 10,{ and on the general issue of regulation of medical I 11 radiation. We received, I think, some good feedback I 12 from that, which helped us in our further work. l 13 The task force then formalized its plan to l t 14 respond to Mr. Taylor's May 17th memo.and we sent a 15 tentative plan to you on June 2nd and the Commission 16 provided the task force with an additional direction j 17 in an SRM dated June 10th and we proceeded on that 18 basis to develop our plans and programs to follow that i 19 direction. In that the Commission requested that we 20 characterize the problems associated with medical j 21 ionizing radiation to the greatest extent possible on { 22 currently available information, identify options that I 23 should be closely evaluated and suggest the database I 24 necessary for a productive evaluation. So that we l 25 took as our three directives, if you will, and j NEAL R. GROSS f COURT AEPORTERS AND TRANSCRIBERS 1323 PHODE ISLAND AVENUE, N W p (202) 234-4413 WASHINGTON. D C. 20005 (202) 234 4433

_ _.. _ ~..._ _ 9 l 1 proceeded with the main emphasis, of course, to 2 respond in terms of providing you with preliminary 3 options that might be viable to meet what we would i 4 j characterize as the problem that we have articulated. i 5 i (Slide) As additional background, I'd 6 like to indicate briefly the current regulatory i 7 framework as shown on slide 2. When we talk about 8 medical radiation today and in our report, we are in i 9 all cases referring to ionizing radiation and we're l j t !i 10 !! not dealing with the subject of non-ionizing i 11 radiation. As you indicated also, Mr. Chairman, when j 12 we talk about medical radiation we're talking about l E 13 use of therapy and diagnosis and otherwise we will be i 14 very specific when we talk about therapeutic uses or i 15 diagnostic uses. .f I 16 The NRC regulation is limited principally L 17 to byproduct material used for diagnosis or therapy { r i 18 and, as you indicated, in therapy this covers perhaps 19 25 percent or so of the administrations. Also 20 important to keep in mind is that we require reports 21 of misadministrations at the user level. FDA' control, 22 on the other hand, regulates all devices and drugs but j ? 23 at the manufacturer level and reports are required by 24 FDA of defective products in the event of death or 25 serious injury, but such reporting is through the NEAL R. GROSS COUAT REPORTERS AND TRANSCRIDERS I 1323 RHODE ISLAND MENUE. N W (202) 234 4433 WASHINGTON. D C, 20005 (202) 2344433 b

._ _.. _ y 10 + 1-manufacturer generally based on information from the j i j 2. user. i 3 Finally, turning to slide 3 -- 4 COMMISSIONER REMICK: Dick, a question on 5 that. i 6 MR. VOLLMER: Yes. i 7 COMMISSIONER REMICK: Are there any cases i 8 where source or special nuclear material is used-in f i 9 diagnosis or therapy? -l 10 MR. VOLLMER: I'd like to ask Chuck. i

l 11 MR.

NORELIUS: The only use of those } 12 materials in the medical area that I'm aware of is - l 13 source material being used as shielding for the . j i 14 teletherapy units and SNM is used for pacennkers. But 15 other than that, I'm not aware of other uses of those 16 materials. 17 COMMISSIONER REMICK: Okay. I thank you. I 18 MR. VOLLMER: (Slide) Okay. Turning to 19 slide 3, the states, who have a broad public health 20 and safety responsibility, have sort of a mixed set of l 21 regulatory responsibilities in the medical radiaticn In the NRC agreement states, the regulation of 22 area. 23 medical radiation from byproduct material. sources is 24 done with compatible programs, but NARM and machine 25 sources, that regulation depends on the state program NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WA$HiNGTON. D C 20005 (202) 234 4433 y m-r g w g --.e- ,4.-e---.e.- -r .--...e,.w-- w +%--w-+*=*.ee-'% ee

i 11 .1 itself. Most agreement states do exercise control 2 similar to that for byproduct material for NARM and 3 machine sources, but that is not necessarily the case. 4 State implementation of NRC requirements 5 also lags our implementation because, in many cases of 6 the need to implement them through legislation and 7 through their state process. So, this provides 8 perhaps another parameter, a variation in the state 9 implementation structure. f 10 The programs in the non-agreement states 11 vary widely since the byproduct material users are NRC 12 licensees who must respond to our requirements. And 13 the users of non-byproduct sources need follow l 14 whatever the state regulations are in effect. Some of j 15 these are fairly strong. Some of these state programs I 16 are fairly strong, but in some cases the state .3 17 programs are very minimal. i' 18 COMMISSIONER ROGERS: Is there.any 19 generalization that you might be able to make about 20 the non-agreement states versus the agreement states 2 21 with respect to devices? Is all that you can say that 22 they vary greatly? I mean is there -- j 23 MR. VOLLMER: Well -- . 24 COMMISSIONER ROGERS: I mean even though 1 25 they vary greatly, is there something that is somewhat I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1 C'3 RHODE ISLAND Av'ENUE. N W I .(202) 2344433 WASHINGTON. O C. 20005 (202) 2344 433 _j

12 l I l' different in agreement states and non-agreement states -i ~ 2 in the way they handle devices? l 3 MR. VOLLMER: Again, I'd like to ask Chuck 4 to address that. I 5 COMMISSIONER ROGERS: Just because in the 6 agreement states they presumably have an integrated 7 program whereas in the non-agreement-states it's a i i 8 little different. t 9 MR. NORELIUS: I don't know that there's j 10 - any further characterization that we could make. One j l [ 11 could probably do a study and pulse each of the l I 12 states. We did not do that. So, I think the best we t 13 can say today is that they vary. i 14 COMMISSIONER ROGERS: Okay. l Ij 15 CHAIRMAN SELIN: It's actually an 16 interesting question because in your report you l 17 pointed out that it was a little vague who you were j i 18 talking about, but that some of the state programs had 19 taken NRC type programs which we had developed for the l I 20 source material devices and had analogous programs for 21 the non-source devices. That's actually a very 1 22 important observation because from first principles if 1 23 the program for the electronic devices is working so 24 well without NRC-type federal regulation, why should 25 we bother regulating the source type devices? If it's I NEAL R. GROSS j COURT PEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.NUE. N W j 4202) 234 4433 WASHINGTON D.C. 23005 (202) 2344433

I 13 l 1 not working so well, maybe the regulations should_be l l 2 extended to the non-electronic devices? It was sort 3 of the germ of an idea that says a little federal l 4 regulation goes a long way, jr,t as an example, i i 1 5 MR. NORELIUS: And that's part of the 6 dilemma that we had with the inability to really 1 7 articulate or compare the dif ferences between programs j 1 i 8 because of reporting requirements and other things, j i' 9 the data set is lacking, to tell how much difference 10 in the health and safety perspective is accomplished l 11 by the application of programs ala the NRC l 12 requirements versus the things the states might set up i 13 themselves. It's clear in some states that the l 14 program is very minimal. They might have a very low l f 15 effort also, but on the other hand some of the states [ 16 are very strong in this area. { 17 We didn't have the opportunity to do that. 18 CHAIRMAN SELIN: Well, you ' re not supposed i 19 to be doing a study, you're supposed to be doing a 20 preparation for a study. But still, that raised l t 21 another question which at some point ought to be f I 22 addressed, and that is a more general question which i 23 is do the non-AEA -- radiation, but non-AEA radiation 24 programs in agreement states, are they generally W 25 stronger than those in non-agreement states? In other [ i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOCE ISLAND AVENUE. N W (2w) 234-4433 WASHillGTON. O C. 20005 {202) 234-4433

. -... ~... -. I 14-I 1

words, one of the basis for the agreement state l

I i I programs is that you would get a better overall 2 i I'I 3 integrated radiation health program if the - same. -l t 4 organization was responsible for all radiation health, j }ii come of it under our standards and some of it on their 5 l' I 6 own? To the best of my knowledge, we've never really f 2 5 7 tried to test that hypothesis. l 8 MR. VOLLMER: It's my belief that that is 9 correct, but I'd ask anybody else who would like to j i 10 comment on that. 11 Lloyd? 12 MR. BOLLING: I would say that with regard .i 13 to the non-AEA materials, we would expect that thO I l 14 would treat those materials the same as AEA materials. 15 CHAIRMAN SELIN: In the agreement states? 16 MR. BOLLING: Yes. i 17 CHAIRMAN SELIN: Yes. But have we ever l 18 looked to see if that's more true in the agreement i 19 states than in the non-agreement states? In other l l 20 words, in the noc-agreement staten you have a real 21 partition of responsibility for radiation health. We 22 directly regulate one

part, the states regulate 23 another part.

Have,we ever looked to see if the part i 24 that the states regulate has benefitted in the l 25 agreement states from being integrated across the NEAL R. GROSS i COURT REPORTERS AND TRANSCRfDERS 1323 RHODE ($ LAND AVENUE. N W (202) 23444a3 W ASH!NGTON. O C 20005 (202) 234-4433

15 l r 1 board. i 2 MR. BOLLING: Not to the extent that we've f 3 looked at it in the agreement states. 4 CHAIRMAN SELIN: It seems to me that at 5 some point we should do that, having a little bit [ i 6 outside your scope but not completely because that's 7 one of the najor original justifications for the j 8 agreement state program. 9 MR. VOLLMER: Yes. As I had indicated i 10 l earlier, the NRC licensees rather than state licensees 11 are onder the state program. So -- I t 12 CHAIRMAN SELIN: Okay. I 13 MR. VOLLMER: -- I believe there is a l l 14 bigger difference, but I don't think we've quantified l 15 it or really proved it out. i 16 CHAIRMAN SELIN: Mr. Telford? 17 MR. TELFORD: There is somewhat of a r 18 confounding influence that when you look at the j + 19 dichotomy between agreement states and non-agreement. l 20 states, it turns out that the states with the largest t I 21 number of medical use licensees, for example i 22 California, Texas, New York, are agreement states. 23 So, if you look at the non-agreement states and look 24 at how many medical use licensees they have, I don t l 8 25 think in general you find states with very many q i i NEAL R. GROSS COURT REPORTERS AND TAANSCR BERS - I t323 RHODE ISLAND AVENUE, N W {

202) 234 4433 WASHINGTON, D C 20005 (202)2344433 i

P +.... v....

. ~.._. i-16 1 licensees. That's true of a large number of even j 2 agreement states. I think I'm referencing some o2 3 I i 3 data that I did a couple years ago, but it's something 4 i like 50 percent or 60 percent even of the agreement + t 0 5h

states, if you look at the number of medical use 6 [

licensees they have, you have to get beyond that point. I i 7 before you exceed 100 licensees. When you get to the l I g top five or six, you see hundreds, if not thousands of 8 1. li 9 lj medical use licensees. So, it's a little bit of a j l i 10 strange comparison, so you have this confounding ( q i 11 influence. h 12. CHAIRMAN SELIN: Pennsylvania, of course, l l i 13 i is not an agreement state and that's the large one. ] 14 COMMISSIONER REMICK: Ohio.- i f 15 CHAIRMAN SELIN: .Yes. l 16 MR. VOLLMER: Okay. Thank you. l i i 17 (Slide) Slide 4 provides our general j 18 approach on how we develop the issues contained in our. 19 report. Briefly we used the Glenn hearing transcript, 20' input from the May 20th meeting with the states, j 21 guidance from the Commission, meetings with the NRC 4 22 staff and so on to formulate the question to be 23 addressed and the issues that would. be related to i 24 resolving that.. question. We then sent our l 25 articulation-of these issues to a selection of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W 1202) 234-M33 WASHINGTON. D C. 20005 (202) 234A433 i

17. - l I stakeholders in the practice and regulation of medical l 2 uses of radiation, and I'll get to who those were in 3 a couple of slides, and requested their views on 4 whether the issues were correct and what would be l 5 possible options for rectification o f ' any problem [ 6 areas. 7 Now, based on the input we received, we l 8 developed our findings and then broadly characterized l { 9 the problem as we saw it based on these findings. We 10 then looked at various options for resolution of the f i 11 identified problems and issues and selected a 12 preliminary set but not an all-inclusive set of 13 options, as I'll get to a little bit later. 14 (Slide) The next slide shows what we 'l 15 believe to be the central question that deals with the f I 16 regulation of medical radiation protection and that is i 17 whether.the current system taken as a whole ensure 18 adequate protection in this area and it should be l 19 noted that the question, while focusing on the issue 20 of public health and safety, encompasses several j i 21 variables, including the state / federal mix of i 22 regulatory control, multiple sources of radiation, and 23 the diagnostic and therapeutic uses of medicine. The 24 question that we believe you asked us to answer and i 25 what we believe Senator Glenn was asking is is the l NEAL R. GROSS l '~ COURT REPORTERS AND TRANSCRIBERS i 1323 HMODE ISLAND AVENUE, N W (2C2) 234-4433 WASHINGTON. D C 20005 (202) 2344433 .1 i

18 ] 1 allocation of a responsibility in the regulation of l l 2 this activity adequate to meet the nationwide goal of l 3 ensuring public health and safety from all sources'of .i 4 radiation. So, from that we proceeded. l I 5 (Slide) And slide 6 lists the related i f 6 issues which are described in more detail in Appendix j 7 B of our report. I think in the respondents to our i r 8 questions or to our request for input on these, there 9 were a few, if any, who stated that these issues were t 10 not appropriate for consideration, although each j i 11 responding to our request had his own focus in terms 12 of the issues that were most important and that's what - f 'f 13 you'd expect. But overall, I think uniformity and l 2 14 regulatory oversight were the most discussed by the -} 15 respondents, followed by database and ' health and I 16 safety. There wasn't a great deal of comment on j i 17 training and experience or communication except that f 18 these were important issues that needed to be enhanced f f 19 and there's a good idea anyway. l 20 I should indicate that in our requcst for 21 comments on these issues we had originally separated f 22 out uniformity and regulatory oversight as two i 23 separate issues as well as database and health and i 24 safety as two separate issues. As you might expect, j i 25 the input we got so intertwined those two sets of 1 NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RMODE ISLAND AVENUE. N W co2) 23u423 w AsHeucTow. O c. 20005 (202) 234 a33

19 1 1 issues that we just brought them together and have 2 combined them in the report and all of our subsequent { f 3 i findings.

i. '

i. 4 CHAIRMAN SELIN: I would just like to make i i 5 ! a point here. I think your statement of the issue is i, 6 the correct statement. In other words, I believe the 7 Commission would feel very differently if it thought 8 I that by say extending or reducing both in a consistent f l 9 l fashion the degree of our oversight we would improve l l 10 ! the health and safety of the public subject to this t i i 11 medical radiation. I think we would be interested but 12 less Interested if we saw that we could get a lot more j r f 13 uniformity and a lot more regularity but without a 14 measurable difference. 15 In other words, if we had the data and it i 16 turned out that risk factors for both AEA controlled 17 sources and non-AEA controlled sources were sort of r 18 comparable even though the documents and the forms j l 19 would drive the practitioners crazy, we would have one t [ 20 view as to the benefit of regularizing them. If there 21 were significant differences in the actual risk [ i 22 factors, we would have a much stronger interest. l I 23 MR. VOLLMER: Yes. ? 24 CHAIRMAN SELIN: So, the way you've stated 25 it, I think', is an accurate statement. 2 NEAL R. GROSS COURT REPORTERS AND TRANSCASERS 1323 RHOCE ISLAND AVENUE, N W l (?O2) 2344433 W ASHINGTON. D C. 20005 (202) 2344433 f '1 3 .n,

i t l 20 1 MR. VOLLMER: Thank you. l 2 (Slide) The next elide, as I promised, -{ l 3 shows the sectors that we contacted and a list of the j 4 actual contacts as provided in Appendix C-of the 5 l report. We attempted to get a representative cross 6 section o f. all the af fected. stakeholders and, of 7 course, the states were an important one and the NRC 8 Advisory Committee on the Medical Uses of Isotopes, 9 also important. I might indicate we held a public l l f 10 meeting I believe on July 8th with ACMUI and it was i 11 done telephonically but here and some members of the l 12 public attended that meeting and a report on that 13 meeting has been issued by the Committee. We, of t 14 course, took their views into consideration here also. j ? 15 Other stakeholders, federal regulatory f 16 agencies. That really is FDA and the NRC. There were .i 17 several federal medical licensees, the service 18 agencies who are licensees of the NRC. We got input 19 fron them. We got input from a number of professional ) t 20 societies, medical equipment and radiopharmaceutical .{ 21 manuf acturers and the a voluntary health organization. 22 We got some input from the American Cancer Society. { i 23 So, these are all listed in our appendix-- 1 24 CHAIRMAN SELIN: The voluntary health 25 organization was the Cancer Society? NEAL R. GROSS court AEPORTERS AND T AANSCRIBERS f ? 323 RHODE ;SLAND At ENUE., f4 W [ i?C2) 2344433 - WASHINGTON. D C 20005 (202) 2344433 l l

l. 21 i 1 MR. VOLLMER: That was the American Cancer 2 Society, yes. .{ 3 CHAIRMAN SELIN: Was there any discussion 4 with people who aren't from the medical profession and 5 medical community? i 6 MR. VOLU4ER: No, sir. We didn't go -- 7 CHAIRMAN SELIN: Information groups or any i l 8 such groups? l-! i 9 MR. VOLLMER: No. That was our limited 4 { 10 set and about as much as we could handle. But we 11 didn't -- oh, that's right. Excuse me. Thank you. l t 12 Judith Brown of ACMUI did provide and j l 13 you'll see her comments are included in that. So, } 14 thank you. Yes. l l P 15 COMMISSIONER ROGERS: With regard to the l e 16 professional societies' comments, they usually take b 17 their time in responding to things vdry - carefully 18 because they have to usually survey their members and i 19 so on and so forth. How official were the responses j 20 that you got from the professional societies and how I 21 detailed? 22 MR. VOLLMER: Let me ask Josie Piccone to ] I 23 respond to that. 24 MS. PICCONE: Yes. These responses were 25 from the governmental affairs people or groups of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W i2 2 234 4433 W ASHINGTON. O C. 20005 1202) 234 4433

~ 22 l' these societies. In a couple of cases, input was from t 2 the professional subcommittee of the societies who 3 normally would have responded at any rate. In most e i 4 cases the professional societies do not go out and 1 5 l survey their membership so that the responses would ~ l 6 come through these routes at any rate. Some of the I 7 groups were able to send material to several people f 8 and received input from a number of people. Obviously 9 the time was short. They had about not quite a two f ) ? 10 l week turnaround and they all indicated that in their j i I 11 ' responses that these were preliminary responses and 12 they were just looking at the broad issue and that's 13 how their responses came back. But we didn't expect l r 14 more than that as well. l 15 COMMISSIONER ROGERS: I think that's 16 pretty good. When I survey their members, I really 17 didn't mean af.1 their members. I meant they usually 18 have to survey all the members of an appropriate l 19 committee. But even that very often takes a lot of i 20 time. 21 MS. PICCONE:

Well, several of the i

i i 22 responses that we did receive were a result of that -- l 23 COMMISSIONER ROGERS: Yes. 24 'MS. PICCONE: -- that they had gone to l 25 their either governmental relations committee or I NEAL R. GROSS l COUAT REPORTERS AND TRANSCRIBERS j 1323 RHODE ISLAND AVENUE. N W. 4202) 234-4433 V"ASHINGTON. D C. 20005 (202) 234-4433 E

) 23 1 professional committees in which a number of members 2 contributed to the response. i 3 COMMISSIONER ROGERS: Thank you. i i 4 CHAIRMAN SELIN: Mr. Vollmer, let me come I 5 back to who we talked to at the states' level. i 6 MR. VOLLMER: Yes. 7 CHAIRMAN SELIN: Could you go a li t.tle { 8 more into the people? Did they include people that 9 you would normally think of as patient advocates or i 10 consumer advocates? 11 MR. VOLLMER: Lloyd, why don't you tell i 12 the Chairman who we sent these to. 13 MR. BOLLING: Yes. We sent the five l 4 14 options with solicitation for additional comments or l 15 views on these different matters to the rad control [ i 16 directors of the 50 agreement and non-agreement j r 17 states. We got responses from 22 and the responses 18 were both to our solicitation by letter as well as i 19 from the May 20th meeting in San Francisco, the public 20 meeting. 21 CHAIRMAN SELIN: The trouble with this 22 contact list is that everybody on the list has got a 23 stake in the status quo and we don't have equal 24 representation.from the people who might be -- or not 25 even equal, even unequal representatic: other than one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AkENUE, N W G02) 234 4433 ~ WASHINGTON. O C. 20005 (202) 234 4433

. - ~. _ i ) 24 ) l' 1 person is a member of the advisory committee. What i 2 would be involved if the Commission asked you to try i 3 H to canvas a set of people that might have more radical j u h I 4 !, use -- I mean every one of these people are either h 5 j! regulators or people who are being reculated and ite::. l 6 not unreasonable to believe that they've grown 7 comfortable with the current system. s, iI 8 i: How would you go about if you had to go 3 9 l out and systematically get views from people who might i 10 ; be less interested in the status quo? 'f l A' 11 MR. VOLLMER: Well, I would likely try to i i 12 ! contact a couple public interest groups and see what [ 13 l interest they would project in doing that. Perhaps l 14 some additional help from HHS and other federal-j 15 agencies would help that. But I'd be happy to put i 16 together some sort of plan for that. j i 17 MR. TAYLOR: Work only with the Federal 1 18 Recister type -- 19 CHAIRMAN SELIN: Also, what about say at i 20 the state level or other levels. There must be j l 21 consumer groups or people who are consumer advocates 22 or people who'd be more likely to reflect the i 23 population that we haven't hit at this point. Is that 24 right, Lloyd? 25 MR. BOLLING: I'm not familiar with those NEAL R. GROSS COURT REPORTERS AND TRANSCR;BERS '323 RHODE ISLAND AVENUE. N W s202) 234-4433 WASHINGTON D C 20005 (202) 234-4433 l

t j' i 25 1 groups. .2 CHAIRMAN SELIN: Commissioner de Plangue? 3 CUMMISSIONER de PLANQUE: Let me just ask 4 a follow-up on that because I see where you're headed. l { 5 When you solicited the opinions of the states, as an 6 example, what information did you send them to ask for l 7 their comments on? I thought I heard you say the five 8 options. Was there much more background material that I 9 you submitted to them? 10 ; MR. BOLLING: There was additional f i I 11 background material. I believe it's part of the 12 package here, isn't it? 13 MR. VOLLMER: It's the issues. 14 COMMISSIONER de PLANQUE: It's the issues. 15 MR. VOLLMER: It's actually our Appendix j 16 B, the issues. I might indicate too that we were 17 originally thinking about going the Federal Reaister 18 notice route, but because of time and scope we didn't 19 do that and we selected to stay within OMB limitations 20 a rather limited set to -- 21 CHAIRMAN SELIN: You are very gracious { i 22 based probably on the fact that you don't yet have 23 tenure on the Commission, but we gave you very little 24 time and very strong constraints on what you can do. l 25 But at least I'm having some second thoughts about it i NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 2344433 WASHINGTON D C 20005 (202) 234 4433

26 ? 1 at this point now. j 2 Just to follow this train of thought in an 3 open fashion, I was impressed that what you got you f J f 4 used not so nuch as votes but as anecdotal information f i 5 that would be useful for follow-up. So, it's not as 6 if we said that of our respondents 98 percent thought 7 the system was terrific and only two percent thought - i 8 it would be changed. But you go into people that have j i 9 a lot of substantive information, got a lot of I 10 anecdotal information, you put it in a reasonable r 11 collage to say, "These are observations that ought to 12 be followed up," and you basically did what you could 13 do given the guidance we gave you. But when it's so l '1C starkly laid out who we've talked to and the fact that i 15 you've gone much further than I personally thought you } l 16 would be able to in soliciting opinions from a number i 17 of people and following up on that, then the imbalance 18 becomes starker Mn seemed at the point. j i .ue and the record ought to show l 19 It l '20 that you asked for permission to go out in the Federal 21 Reaister and that was denied. That was denied. 'l l 22 Please continue. I 23 MR. VOLLMER: Thank you. t i 24 (Slide) Now turning to the findings, 25 which start on slide 8, we're not surprised to find NEAL R. GROSS l COURT AEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N V'. {

202) 234-4433 WASHINGTON. O C 20005 (202) 234 4433 j

j f'

27 } 1 what we found on the first

bullet, that is i

i 2 inconsistencies in the overall regulatory framework. j i 3 We could have found out without too much study [ l 4 because, as we indicated, we have two tederal agencies 5 and one set of states who are major players and that i f 6 doesn't necessarily create the inconsistencies but 7 there's a great deal going on out there which i' 8 inherently at the user level izives one to set up I 9 different programs for different activities. 10 Since the NRC obviously has a strong i 11 regulatory role for its licensees and for the 12 agreement states, this provides an opportunity for ) 13 those that are not required to fall within those j 14 regulations to do things differently. I thin 1. we i 15 articulated before how much that happens in the broad l 16 general sense, but certainly not in the specific sense 17 because we just don't know right now and I think l l 18 that's something we would like'to learn. 19 But as I indicated before with the .l 20 difference in focus of the FDA and NRC regulations 21 also, theirs is being focused at the manufacture level-22 and much of ours is being focused at the user level. 23 As I indicated, since the states deal differently with' t 24 different sources of ionizing radiation or at least. j 1 25 can within their purview, this results, for example,- I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W GC2) 2344433 WASHINGTON. D.C. 20005 (202) 234-4433 I

( ) 28 I i' 1 l in significant dif ferences in reporting requirements. I 2 l So, it's dif ficult to get a complete set of data under i 3 ! the current structure. 4 l 4 Not that I'm suggesting that one would j 1 5 ; have to have a complete set of data in order to make i t 6 a better judgment than we could make on whether or not 7 there's a health and safety problem, but certainly we i 8 couldn't do that but I think one could use available 9

data, could usa the information, the enhanced 1

t 10 p reporting that FDA 1s going to be asking for, and I'll i ( i 11 get to that in a minute, to in the fairly foreseeable l l 12 future to get a better handle on that without going l l l 13 necessarily to a very, very complete data set. 14 Cl! AIRMAN SELIN: Could I just stop you for 15 a second? 16 MR. VOLLMER: Yes, sir. l' 17 CHAIRMAN SELIN: We're reasonably well l [ 18 aware of what the strengths and limitations are in the j 19 AEA controlled things. We think we have reasonably i 20 good misadministration data from the NRC directly 21 licensed states and the expecta*.?n that in the next + 22 several years we'll get compi elle data from the j i 23 agreement states. We know how weak the denominator 24 is, the information on proper administrations, but at i i 25 least there are some crude estimates for that. j NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W. L232) 2344433 WASHINGTON O C. 20005 (202) 234 4433

F 29 i 1 Is the situation noticeably worse for the 2 linear accelerators as far as misadministrations or [ 3} overall figures? I 4 l MR. VOLLMER: I'd like to ask Don Hamilton 5 : to address that. MR. HAMILTON: The Center for Devices and 6 i 7 Rad. Health has a legislative mandate to operate a 8 medical device reporting program that looks at all-9 medical devices and would include in the radiation l l 10 l medicine area not only the t eletherapy units but also 11 linear accelerators. We surveyed the database in that 12 program for both AEA and non-AEA areas and we find 13 that it's not too much unlike what we see as far as 14 NRC saying that they -- what is it, 25 percent'of the 15 area. We see about three times as many reports in the t 16 accelerator area as we do in the teletherapy arena. 17 So, they're comparable. l 18 CHAIRMAN SELIN: Misadministration 19 reports? i { 20 MR. HAMILTON: Misadministrations is a i 21 dif ficult term and Mr. Vollmer will point out a little 22 later we're trying between FDA and NRC to coordinate 23 that kind of definition. We get reports ^ when ' the 24 device malfunctions or when a manufacturer would give 25 us a report that might have been reported to him as a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. 202) 234-4433 WASHINGTON. D.C. 20005 _ (202) 2 % 4433 a. l

~ 30 ij 1 malfunction but was determined later to be a user 2 error. 3 CHAIRMAN SELIN: I see. 4 MR. HAMILTON: We do not see 5 misadministrations that are directly user errors. f i 6 CHAIRMAN SELIN: So the user errors, i 7 unless somebody would kill through a user error, you !i 8 might hear that. l t 9 MR. HAMILTON: That's true. l i 10 CHAIRMAN SELIN: Okay. But that point I'm P 11 trying to make is that this second set shouldn't be 12 read that the NRC regulated radiation cannot be 13 subjected to a health and safety finding. You're i 14 talking about comparisons among the dif ferent types of j l 15 radiation if there's an overall health and safety l l 16 problem that requires a major change in regulatory I i 17 jurisdiction? i 18 MR. VOLLMER: I'm sorry, the second -- l 19 CHAIRMAN SELIN: Yes, the statement says, j 20 "Information are currently available for definitive r 21 health and safety findings."

Well, of

course,

{ l 22 de initive is such a strong word.. But if we took out. l I understand the emphasis of your 23 the definitive 24 observation to be that you're not doing a reevaluation 25 of the health and safety of NRC regulated medicine, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 HHODE ISLAND AVENUE, N W j I 202)234-4 03 WASHINGTON, D C. 20005 (202) 234-4433 I

s.

I 31 1

but a look overall and say there's not a clear need in terms of a lesser quality of health and safety in the 2 3 non-11RC regulated area to call f or an extension there. 4 MR. '!O LL'<E R : (Slide) Would you put slide 5 8 up? i 6 Mr. Chairman, I think unfortunately you 7 have -- there was one change made in that, if you 8 if could look at that. 9 CHAIRMAIJ SELIIJ : Okay. 10 MR. VOLLMER: We've characterized it a 11 little differently. _atually we 've written what's -- il. 12 :; thank you, sir. Il 13 j' We've written what was in our finding and l' 14 I we've articulated it a little differently in this ill! slide, which is more appropriate, and that is the 15

ll l

Inf ormation is not currently available to determine if ll 16 ir 17 there's a health and safety problem. l 18 ! CHAIRMA!i SELIII: Okay. Fine. I l MR. VOLLMER: And I think -- okay. 19 20 COMMISSIOllER ROGERS: I'd like to come to { the point in your report on page 4 about the look to 21 22 the states to see the need for additional data, but 23 ' this may not be the right place to do that. But I l 24 would like to hear a little bit more on your vicWs of l 25 ! that. t I l NEAL R. GROSS I COUAT REPORTERS AND TRANSCR;EtE AS 3 RHODE iSLANLgoENUL. fi W '02) 234 4433 AASHINGTON. D C 2XO5 *'4 (202) 234-4433

i 32 ~ I 1l MR. VOLLMER: All right. Thank you. 2 The next principal finding is that which i }l you mentioned, Mr. Chairman, and that is that there's 3 l! I l h. not sufficient information currently available for all 4 5 uses of ionizing radiation to determine if there's a r 6 ;, Ilealth and safety problem, the magnitude of the 7 problem if one exists, and the need to reallocate [ l-l regulatory responsibilities. We think this is sort of. f 8 I t 9 j a key issue since it gets to the heart of the question l l' i 'i c 10 ;j we were asked. .l

i J-1 It seems to us that an evaluation of the 11 l-r 4

12 health and safety significance of the problem is j 13 warranted. As I indicated before, it's not clear from 14 our limited study that the expense of establishing a l i 15 a very comprehensive database as described in Appendix I 16 B is warranted, but I think some look at what's out 17 there in terms of data and how that could be evaluated l 18 and analyzed to get a sense of whether not there is a 19 health and safety problem is what we should do. i 20 Now, from a regulator's perspective, we 21 respond as we should to any significant health and 3 22 safety problem we see on an individual basis, but we 23 just don't have the wherewithal to put that together 24 in terms of, if you will, a safety goal for medical l 25 radiation or how that safety goal might compare. I'm NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE fSLAND AVENUE. N W -[

202) 234 4433 WASHINGTON. D C 20005 (202) 234 4433

~ ) 33 i 1 just using a general term here .without any i 2 quantification, or a safety goal for medical radiation 3 if one compares that to other medical treatments, 4 either modalities in radiation or broadly speaking. 5 So, and I'll get to it later, this, as we t 6 understand it, is something that the National Academy 7 will be looking at and we think it's appropriate. 8 But again, the greater problem seems to be 9 one of uniform reporting from all sources to assure l 10 awareness of the events. That would help just in the 11 database itself because one could make judgments on 12 the denominator and come up with factors. If you had l 13 similar reporting across the nation, you could come up i 14 with a sense of whether or not one type of regulation, f i 15 i.e. the NRC type versus the non-agreement state types i I 16 that don't have or may not be applying our licensee { i 17 type requirements to their licensees or certification 18 holders, if there are any differences' in the real f 19 health and safety impact of that, j 20 CHAIRMAN SELIN:. But there's nothing even 21 remotely underway that would produce mistakes in the 22 use of non-NRC, non-AEA ionizing radiation, is there? ) 23 We talked about devices, but as far as -- 24 MR. VOLLMER: Well, except for what they 25 .might get on the user level. Again, I guess it could NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, f4 W 272) 0344433 WASHINGTON. O C. 70005 '(202)2344433 =

a i 34 1 be anecdotal but there's certainly no requirements of 2 that. I 3 CHAIRMAN SELIN: There's

nothing, no 4

survey or nothing that would have the effect for the 5 non-AEA. material that Part 35 is supposed to do to 6 the 7 MR. VOLLMER: Not that we're aware of. 8 COMMISSIONER ROGERS: Just before you turn 9 from that I wonder if Mr. Hamilton could give me just I 10 a little bit better understanding of how FDA 11 approaches its analysis of devices from a standpoint 12 of the possibility of an accident. In other words, 13 how would you characterize the examination that FDA 14 does of a medical device in its approval, that 15 invclves radioactive material? What would be the 16 kinds of things that FDA would want to look at there? 17 MR. HAMILTON: Devices would go to market 18 in one of two ways within FDA. The process which we 19 call the premarket-approval, which would be -- in 20 fact, do not at this time contain any devices that 21 contain radioactive sources that I'm aware of. The 22 primary way is what we call our 510(k) process or our 23 notification that a manufacturer has a product that is 24 substantially equivalent to a product that is 25 currently on the market. Our Office of Device NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W C2) 234 4433 WASHINGTON. D C. 20005 (202) 234 4433

i f 35 1 Evaluation t would look at the manufacturer's { 4 2 application that would show detailed information about j 3 how that device is equivalent to the device that is l 4 currently marketed. We would then look at a number of l 1 5 f actors as to how it's produced and the labeling of it 6 and things like this. We do not do anything specific 7 relative to the radiation properties of it other than i I 8 to make sure that there is basically no public health 9 or safety hazard involved with it. l 10 COMMISSIONER ROGERS: Well, I guess what l 11 I was trying to get at is -- it sounds to me as if 12 your focus is on the medical efficacy of the device, 13 if it's to substitute for something else, but what i i ? 14 about questions of its vulnerability to. failure. I'm i J i 15 thinking of the brachytherapy device where the wire j i 16 failed and resulted in the source being left inside a 17 patient. ~ I 18 Would you be looking at matters such as l 19 that, namely possibilities of failure of the device' { } 20 that could lead to an accident, a misadministration of '} l l 21 some sort? 4 22 MR. HAMILTON: I believe that we do. I 23 think that that process-is going to improve with the 24 implementation of the memorandum of understanding 25 between the two agencies because the NRC, at least in i l NEAL R. GROSS l COURT AFPORTERS AND TRANSCRIDERS ) 1323 HHODE ISLAND AVENUE. N W I 2202) 234-4433 WASH;NGTON. O C 20005 (202) 2344433 ')

L 36 1 -the AEA products, has a good source integrity type 1 2 program and I think communication between the two 3 agencies in that area will improve that operation. 4 COMMISSIONER ROGERS: Well, what about 5 those areas where NRC is not involved in other kinds 6 of devices that NRC wouldn't be involved with? I 7 MR. HAMILTON: I think that our people in. I 8 the device evaluation group would use the same kind of t 9 criteria in their examination of the product, just'a { l 10 transfer of the technology from non-AEA to AEA within f 11 house. 12 COMMISSIONER ROGERS: Do you have any 13 -particular in-house directives to require that? 14 Sometimes the right hand doesn't know what the left i 15 hand is doing, you know. l 16 MR. HAMILTON: We have what we call -- t i 17 within the Office of - Device Evaluation, there are i 18 review guidances that are set up for the review { 19 of ficers that look at specific kinds of products. I'm 20 not that closely familiar with which guidance would be 1 21 done for radiation therapy products that were non-AEA, I 22 though. .i 23 CHAIRMAN SELIN: Could I just follow-up,. 24 Mr. Hamilton? Today, you know, without the MOU, i 25 without future' -- do you, does the FDA through NEAL R. GROSS { COURT REPORTERS AND T: ANSCRIBERS 1323 RHODE ISLAND A'.ENUE, N W 'j 1202) 234 4433 WASHINGTON, D C 23005 (202) 234 4433 l .i

4 37 ~ 1 information gleaned from our misadministration i 2 reportings get insights in reviewing the AEA type 3 devices that you don't have for the non-AEA i 4 i radiological devices? I 5 MR. HAMILTON: I think that's true, yes. 6 MR. VOLU4ER: (Slide) On slide 9, the 7 next slide, we indicate that improvements could be 8 made within the existing regulatory framework. We 9 l believe that ongoing activities within the NRC, such I 10 i as the management review of the medical management f 11 plan and lessons from the recent' incident i ~ 12 investigation team

report, will improve NRC's 13 regulation of the medical use of radiation.

14 At the FDA, their new requirements for i 15 facility user reporting of adverse events, as Don j 16 indicated, there's enhanced manuf acturer. reporting, 17 enhanced state and FDA cooperation and information ' ? 18 exchange. These things were indicated, I think, by 19 Doctor Burlington in his previous testimony. l 20 In addition, the NRC/FDA memorandum of 21' understanding we think will lead to better knowledge 22 of the systems and the problems on both sides. And 23 .again, that's basically I think what Don was saying. j 24 And fi'nally, the National Academy of 25 Sciences study will deal with a number.of areas that l k NEAL R. GROSS -r COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISi.AND AVENUE. N W. p Q 234433 WASHINGTON. D C. 20005 (202) 234 4 33 t

4 38 1 we believe need study to answer the question ' of 2 whether to change the regulatory framework, such as 3 the risk of treatment by ionizing radiation compared r 4 to other modalities and recommendations for a national 5 approach to the regulation of medical radiation. 6 So a lot of these things are germs that. 7 are in what we think need to be done and I think what 1 8 we're saying is a lot of them are apparently underway. l 9 We think they'll be fruitful, so that's why we've 10 included the things that are going on in our option 1, [ 11 because we think it would be sort of a stark option if 12 it didn't include the fact that a lot is going on and 13 a lot is going -- s 14 CHAIRMAN SELIN: Your status quo ante is i 15 not just the current system, but the current system as l 16 it might be improved so that -- 17 MR. VOLLMER: The current system, sort of [ 18 betting on the calm, that the things that are going on i i 19 now, most of these are going on -- 20 CHAIRMAN SELIN: You have to try to a 21 separate out benefits from changes of jurisdiction i I 22 versus benefits just from better management? E l 23 MR. VOLLMER: Yes, sir. 24 CHAIRMAN SELIN: Okay. I 25 MR. VOLLMER: Now our final principal i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVEt4UE N.W. l (202) 2344433 WASHINGTON. D C. 20005 (202) 2344433

t 39 t 1 finding.was we found that, despite the lack of l 2 definitive risk data and recognition that there are 3 opportunities f or improvement, it's not clear that the j 4 current regulatory framework does not adequately 5 protect the public health and safety. .i 6 Federal and state programs already in I 7 effect combined with professional medical practices i 8 and voluntary professional standards appear to have i 9 served the public health and safety and we, in the l 10 look that we did, we couldn't articulate it any 11 differently. We think that a lot that is going on is 12 done well. 13 There are inconsistencies. It is a 14 patchwork quilt, if you will, as I think was indicated 15 by the Senator, but we couldn't -- it wasn't clear to i 16 us that we're not adequately protecting the public 17 health and safety. To find one way or the other, we i 18 would need more data and better consistency in how 19 that data is articulated. 20 (Slide) Moving on to slide 10, it is 21 simply our characterization of the problem as we see l 1 22_ it. As we see it, it's a lack of a fully coordinated 23 regulatory effort as well as a lack of suf ficient data 24 to evaluate the effectiveness of the effort, so it's l '25 a two-handed thing. It's not just that the effort:is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RwODE ISLAND AVENUE, N W <202) 234-a433 - W ASHINGTON. O C 20005 (202) 234 4:33

tm.- a I 40 1 a bit inconsistent and patchwork, but we really can't ) 2 tell how well it's serving the public because of the 3 lack of data to evaluate it across federal and state i 4 agencies to achieve the national goal of adequate i 5 protection of the public health and safety. That's 6 how we have characterized the problem. 7 COMMISSIONER ROGERS: Just before you f i 8 leave that, Dick, what would -- it may sound trivial, 9 l but what do you really mean by " effectiveness"? I 10 mean, for example, one could simply mean that really 11 there is with more data a clearer demonstration that 12 the public health and safety is protected. Get more 13 and more and more data, you get more and more 14 confidence, but nevertheless there's nothing changed 15 in terms of the bottom line conclusion. 16 On the other hand, effectiveness very i 17 often also combines not only results but the use of 18 resources required to achieve those results and we { 19 might have a very effective program from the 20 standpoint of protecting public health and safety but 1 i 21 an ineffective program from the standpoint of the - 22 resources that it eats up that might in fact be used 1 23 for otNr public health and safety benefits. 24 So do you have in mind that combination of i 25 ef fectiveness really encompassing the notion that it's NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202)2344433 WASHINGTON. D C. 20005 (202) 234-4433 9 -,,r,- e: -, ---~,

~ 41. 1i an efficient system as well as delivering, not only 2 [ does it deliver a result but it does it in a 3 reasonable way? 4 MR. VOL124ER: Yes. That's my feeling for. L 5f what's in mind here and when we get to the options 6 you'll see more of that. But we would agree that one 7 could lay on - a tremendous amount of regulatory f I 8 trappings here which may improve or may decrease the 9 incidences that happen and things like that, but the 10 cost effectiveness is I think what I meant there. If 11 anybody cares to comment otherwise -- but I think I 12 that's it. t 13 The effectiveness in one area, one would for example, the application of NRC 14 have to 15 requirements, how effective that is from a cost 16 benefit point of view as opposed to what agreement t 17 states do in other areas or even non-agreement states 18 do for a NARM machine is an answer we don't know,.but 19 it's the effectiveness in the broad sense that we're 20 talking about. 21 (Slide) Moving on to slide 11, we're I 22' getting.into the options-here. Before we deal with j 23 the

options, I'd like to indicate a

couple of 24 comments. 25 One is that of course there were other NEAT. R. GRCSS COURT REPORTERS AND TRANSCRIBERS. 1323 RHODE ISLAND AVENUE, N W. 1202) 234 4433 WASHINGTON, O C. 20005 (202) 2344433 m

. - ~.. _. - . ~. - - t 42 1 ' options-that had advantages that were attractive and 2 had support from respondents. The ones that we've 3 identified you'll probably see why we did it from a ) 4 consistency point of view and so on, but I'll get to j 5 that in a minute. I i 6 But, for example, if uniformity was the-7 keystone that we were looking for here, then one could 8 argue for a full federal control or setting of 9 regulations and their implementation without an { t 10 agreement state program. For example, we would set 2 11 the regulations and we'd be responsible for licensing - 1 12 and inspection and enforcement, which is what I mean 13 when I say " implementation" in this sense. Keeping in 14 mind that our definition of implementation means that, 15 one would -- there would be a burgeoning amount of 16 federal resources required if we took on that role, 17 but, again, it might be the most -- the best way to l 18 take care of uniformity if that were the keystone i i 19 problem. l 20 on the other hand, one'could, argue that .I i 21 the federal government should be responsible only for l ii 22 basic radiation safety, as in Part 20, and 'not' set any 23 requirements for impinging on the delivery of 24 radiation to the ' patient. There was certainly outside 25 support for this. I I NEAL R. GROSS-l COURT REPORTERS AND TRANSCRIDERS 1323 HHODE ISLAND AVENUE N W- ~! G2) 2344433 WASHtWGTON, D C 20005 (202) 234 4433 - + - - - ,., - + -~

43 1 So these two examples would represent an 2 end of a spectrum which had attractiveness either to 3 meet an identified problem or had attractiveness to 4 some of the people who are very intimate with the 5 delivery of this to patients. Either could be found 6 to be attractive depending on the outcome of a better 7 evaluation. We wouldn't count those out, but the 8 important question that we tried to address was to try 9 to get a set that we thought met a number of the 10 issues, could solve a number of the issues, and we 11 didn't want to preclude other options by defining a 12 preliminary set here that might be well considered for 13 other reasons. 14 Getting on with the preliminary options 15 themselves, this number one option is sort of the 16 status quo with recognition of the planned and 17 potential improvements from those activities that I 18 had mentioned earlier in the findings. We think it's 19 important to make these improvements, as I indicated 20 in part of the option, but I personally believe that 21 it would still be the option of choice at this point 22 in time, even if there weren't such a broad spectrum 23 'of improvements that might lie on the horizon, because-24 again I don't think we've been able to tell that there 25 is a health and safety problem anyway. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W (202) 2344433 WASHINGTON. D C 20005 (202) 2344433

~. _ _ s f 1 CHAIRMAN SELIN: You weren't asked-to 2 choose an option. You.were asked to -- 3 MR. VOLLMER: No. No, sir. I wasn't 4 trying to do that. 5 CHAIRMAN SELIN: Right. But can I go back j 6 to something you just said before you put the options f 7 up? In reading the report, I was struck -- given the 8 people you talked to, I wouldn't expect many people i 9 calling for more regulation, but I would have expected 10 some kind of a sentiment to ask us to cut back not 11 just on how we do the misadministration but that 12 there'd be a powerful group out there that would say, { 13 "Why don't you just do sources and keep out of the j 1 14 medical use of radiation?" I didn't see that in the j 15 report. i 16 The impression I got was a comfort with f i 17 the status quo, even among people who you would think i i 18 would have an interest in lightening the federal hand 19 of regulation. Did I misread your results? t 20 MR. VOLLMER: Well, I'll comment and open i i 21 it to anybody else who would like to comment. 4 I-i 22 I don't think you did. For example,. 23 think the states in many cases at the meeting we had. l 24 on May 20th would indicate that they would like the i 25 federal standards set. Now they didn't suggest 1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 PHOCE ISLAND AVEtwE, N W i202) 2344433 WASH'NGTON, O C. 20005 (202) 234 4433 ~i?

1 r L 45 l' backing off from some of the other requirenents. I J 2 think there was more of a set of uniform standards i t hl that they'd like to be able to deal with. I think 3 4 they were perhaps comfortable-with the current 5 l situaticn. In my recollection of the input we 6 l 7 received, there was not a strong -- there were some, a but not a strong emphasis on backing off to the extent l you suggested, although what I just discussed a minute j 9 10 ! ago would imply that, that we would set the standards i i 11 and not deal with the user level. i 12 Anybody else? I think that represents -- i 13 COMMISSIONER ROGERS: But you indicated 14 that's just sort of one end of the spectrum of 15 possibilities, not necessarily one that emerged from 16 your studies. I 17 MR. VOLLMER: That's right. It didn't i IS emerge from ours, but it's certainly one that -- 19 COMMISSIONER - ROGERS: Some people have 20 espoused, right. i i 21 MR. VOLLMER:- -- might very well be~ l l 22 attractive. And if we had the data to show that, for 23

example, our regulation at the user level didn't 24 really help a heck of a lot, then you could argue that i

25 maybe that would be a good approach to pursue. We NEAL R. GROSS COURT HEPORTERS AND TAANSCRIBERS 1323 RHODE ISLAND AVENUE, N W- -(202)2344433 WASHINGTON. D C 20005 (202) 2344433 m. -.9-

f 46 l l 1 don't have that data. 1 I 2 CHAIRMAN SELIN: Okay. Please continue. f 3 MR. VOLLMER: Okay. We've just listed 4 sort of the pros and cons briefly. We discuss them f 5 much more in the report. For one, of course, the i 6 agencies were considered in their current roles. We l 7 talked about the initiatives, but it doesn't address ) B the fragmentation and inconsistencies that we talked j i 9 about before which may or may not be problems when it l 10 comes to the bottom line, protection of the public i 11 health and safety. We just don't know. l l 12 (Slide) The next slide, slide 12, shows E 13 an option where the federal government develops the 14 requirements and implements them in an agreement l l 15 state-like program for all sources of ionizing 16 radiation used in medical therapy. So this option, t 17 you could argue, sort of spreads the NRC model to all i 18 sources of radiation across the. board and would 19 utilize an agreement state-like program to -- l l 20 CHAIRMAN SELIN: This means that, assuming I i 21 that this change didn't change the desire for states, 22 the agreement states, that in 21 states we would 23 inspect and regulate for all sources of ionizing 24 radiation used in medical therapy; and the other'29 25 states, the agreement states, would continue to do NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVEf4UE, N W .202) 234 4433 WASHINGTON. D.C 20305 (202) 7344433

i 47 1 what they're doing but they would have to do it 2 against our standards and our regulations, for the so f i 3 far nonexisting standards and regulations for linear 4 accelerators? { 5 MR. VOLU4ER: I would agree with what you t f r 6 said, except where you use the word "we" and "our." 7 We're talking about a federal somebody. 8 CHAIRMAN SELIN: Okay. Without saying 9

who, i

10 MR. VOLLMER: Yes, but at the federal 11 level exactly as you articulated. That would be this .2 option, yes, sir. l 13 CHAIRMAN SELIN: Okay. i 14 MR. VOLLMER: We think this would have a 15 fairly substantial impact on federal resources-16 relative to some of the other options but would j 17 provide perhaps the best level of uniformity, and of 18 course this particular option is for therapeutic 1 19 application only and would not cover diagnostic. So, 20 again, the task force had in mind for this option 21 regulations similar to those currently in effect for 22 byproduct material by the NRC extended to all sources, 23 therefore this would be an NRC-like program.for all 24 sources. 25 A variation of this could, for example, NEAL R. GROSS COURT AEPORTE R$ AND TRANSCRIDERS 1323 AHODE ISLAND ALT _NUE. N W (202) 234-4433 WASHINGTON. O C. 20005 (202) 234 4433 i .i

48 I have the requirements extend only to the point of user jl 2 application or some other point in the delivery system 3 and so you could set the standard of how far the 4 system went down. In other words, Part 20 all the way 1 ) 5 l down to Part 35 one could set where you want to --- if t 6 you knew enough about it, where you wanted to set the 7 discriminator for regulation and use a consistent 8 system across the board in an agreement state program. ? 9 That's sort of the option that we have in mind here. l 10 We just don't know enough to even suggest where that 11 discriminator would best be set, again because the j 12 information is not available. j 13 The pros and cons of that we've tried -- i 14 you'll find a number of these things, pros and cons, j f 15 reduction of state authority, requires legislation, i i d 16 increased federal cost. I think I procably should 17 have ranked these a little bit more definitively, but 18 we ran out of the words here to modify some of these 19 options. But clearly, since this one would have the 20 federal government develop and implement regulations 1 21 for all sources, it would be the most costly from the 22 federal government's point of view and it would 23 probably decrease the states' authority to the largest 24 extent possible in addition to that. But on the other .f 25

hand, it might be the most uniform in terms of NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS 1323 AHODE ISLAND AVENUE. N W k

(202) 2344433 WASHtNGTON. D C. 20005 (203 234-4433

P ? 49 1 application, so, you know, you get one thing but you 2 lose something else. 3 Option 3 -- i 4 COMMISSIONER ROGERS: Excuse me. Before 5 you go to option 3 -- l 6 MR. VOLU4ER: Yes? l 7 COMMISSIONER ROGERS: -- it isn't so clear [ 8 to me that there would be a long-term increase in i 9 federal cost under that program. Since it is an 10 agreement state-like program where the 11 responsibilities are taken up by the states, there i - 12 would be some increase in cost in the beginning in 13 developing the regulations and so on and so forth. 14 But once it's handed over to the states, why would it i 15 necessarily involve increased federal costs? i 16 MR. VOLLMER: If all states became j 17 agreement states, that would be true and then you I i 18 would be going into option 5. But in this case. 19 basically we're talking about implementation by the 20 federal government in an agreement state-like program. 21 So where you didn't have the agreement state we would l -l 22 have the responsibility, where you did'we would have j .i 23 responsibility for-certain oversight -- l 24 COMMISSIONER ROGERS: Some oversight. 25 MR. VOLLMER: -- in setting compatibility i NEAL R. GROSS j COURT REPORTERS AND 1RANSCRIRFRS 1323 RHODE ISLAND AVENUE. N W. (202)234 4433 WASHING 10N, D C 20005 902) 2344433 ^ i

50 i 1 standards and things like that. t 2 CHAIRMAN SELIN: But in 21 of the states. i "we" the federal j 3 as of today, we would have -6 4 government l 5 MR. VOLLMER: That's right.- 6 CHAIRMAN SELIN: -- to take an expansive f 7

view, would have to do the actual licensing and j

B inspection. 9 MR. VOLLMER: Theoretically, it could be j t i 10 that, if states became agreement states, then we would j i 11 only have the compatibility burden and the setting of j 12 regulation burden, yes. j 13 (Slide) Next slide. I can tell which one 14 it is, then. Option 3. 15 COMMISSIONER ROGERS: Number 13. i 16 COMMISSIONER de PLANQUE: Slide 13. 17 COMMISSIONER ROGERS: Slide 13. f 18 MR. VOLLMER: Okay. I was unfortunately f I 19 speaking a little bit to that just a minute ago, but. I 20 that includes diagnostic as well as therapeutic, in j 21 other words extending the NRC-like program to all. l t 22 sources in both diagnostic and. therapeutic with an l ) l 23 agreement state-like progran for.all sources. If I t 24 misstated before, this is the one I meant would be the 25 highest federal cost certainly in the short-term and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 MODE ISLAND AVENUE. N W. '202) 2344433 WASHINGTON. O C. 20005 (202) 2344833

51 I I 1 perhaps even longer. 'l 2 CHAIRMAN SELIN: This would basically pick i 3 up -- option 2 picks up linear accelerators and option { 4 3 picks up x-ray machines, basically? l 5 MR. VOLLMER: That 's right. That's right. 6 That's correct. 4 t 7 MR. NORELIUS: And other diagnostic uses 8 of radioactive materials, say thallium use, which is l 9 a big one. t i i 10 COMMISSIONER REMICK: I assume that if we 11 did something like this where we picked up the l 12 responsibility, being "we" the federal government, fcr f 13 non-AEA materials in devices like x-rays, it would not 'l I 14 only be limited to the medical uses, be x-rays used in 15 research also, presumably. 16 Once you get into that game, there are { t 17 some pretty hairy uses of x-ray machines in research j i 18 which are much more complicated perhaps than in l 19 medical because the devices are modified and so forth l 4 20 for special research applications. Although we're l 21 talking about medical here and we talk about getting i 22 into these other areas, there would be other uses than 23 medical that -- 1 .24 MR. VOLLMER:

Yes, j

i 25 COMMISSIONER REMICK: -- presumably would ' NEAL R. GROSS l 1 COURT REPORTERS AND TRANSCR$ERS j 1323 RHODE ISLAND AVEtJUE. N W ' (202) 2344433 WASHINGTON, D.C. 20005 (202)2344433 l i

.l 52 1 1 come under and I can see there would be increased 1 2 costs. 3 MR. VOLLMER: Yes, sir. I agree, and we ) 4 talk about that on the top of page 8 and say, i 5 basically, if we allocate regulatory responsibility in f i 6 this way, that it would be beneficial to consider all j i 7 similar use of radioactive material, industrial, f i 8 academic, research, and medical. So we think that's 9 true, yes, sir. ' i 10 COMMISSIONER REMICK: That's what I had in i 11 mind. Thank you. s 12 MR. VOLLMER: Okay. Option 4, I think, f I 13 gets into a little different slant. The two options i ) 14 that preceded were parallel in the sense that they 15 would extend NRC-like application to both therapeutic 16 or all uses with the agreement state type of process. l 17 These, option 4 and 5, are also parallel in the sense j 1 18 that the first, number 4 here, applies to therapy and j 4 i 19 number 5 will apply to diagnosis and therapy. j r i 20 Now both of these would have the federal j -i 21 government set the regulations and the states would be .{ 22 fully responsible for implementation as-they now are i i i 23 for NARM machines, so we would basically be providing l 24 the standards. -In this one we weren't _ thinking of the j 25 state program. We were thinking of the federal l NEAL R. GROSS COURT REPORTERS AND TRANSCalBE AS 1323 AHODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. D C 20305 (202) 7344433 l l

i 53 ~ 1 government really pulling out of even the requirement 1 2 for implementatior. in the non-agreement states as well i i t 3 as the assurance of compatibility and oversight in the l 4 agreement states, so this is backing off a little bit 5

further, f

6 We think that uniformity would be lessened I 7 by this, but on the other hand one could argue, l 8 perhaps rightly so, that the states could set up l 9 something like the conference of radiation control '0 program directors or something which, if the states f 11 really joined in, that or some other organization t 12 could provide implementation standards and perhaps i 13 implementation assistance. So you might end up with { 14 a fairly effective system in that way with the federal f 15 governuent providing the oversight, the uniformity in -l 16 terms of regulations. 17 And again, as before, those regulations i 18 could be discriminative or could be set at whatever l 19 level. We were thinking broadly sort of at the user f 20

level, but you could back off all the way up to 21 wherever you wanted to back off to so that you 22 wouldn't impact the user level or the patient delivery l

23 level. 24 (Slide) And finally, as I indicated, the l l 25 next slide is simply the same as 4 only it deals with i i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. l 4202) 2344433 WASHINGTON, D C. 20005 (202) 2344433 l

O. il 54 Hq 1 !! therapeutic use and diagnostic use. l d 2 l CHAIRMAN SELIN: It seems to ne that 3 there's another real option that hasn't been looked 4 ! 4 at, and that is to treat all medical use of radiation l 1 the way we now treat linear accelerators, in other 5 : i i 6 H words where the federal government just backed out of i ]) the medical use material and we just said we will 7 8 regulate the sources just as we do any other sources. 4 You have to have alarms and you have to follow the i 9 .i 10 rules in hc.ndling the cobalt, but as far as the j l 11 medical applications to just back off. g:. l l 12 My original view is that we're in an 13 unstable situation at this point where we have a large q 14 degree of regulation in one kind of radiation and very r low in another and it's illogical. i 15 i + 16 i Now one set of things says in different 17 ways we should extend the federal domain to the non-t 18 AEA sources to varying degrees. Another would say t 19 that the linear accelerators are no less safe than the i 20 cobalt devices, "why not back off and let the states l regulate the cobalt devices the way they regulate the l 21 i I 22 linear accelerators?" and I think it's important that i 23 such an option be considt. red. Now you could consider 24 j that as the limit for option 4, but I think it's l l 25 really a fundamentally different option where it just l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. l 202)2344433 . WASHfNGTON. D C 20005 (202) 2344433 .l

) 55 i 1 says we will do less. The federal government doesn't 2 often look at that and I'm not saying that's what we 3 would do, but I think that's a real option. 4 MR. VOLLMER: Yes. I think it is. We i 5 talked about that. It would be a variation of 4, I i 6 think, with a discriminator set pretty far back in l 7 terms of federal interaction, but certainly that is i 8 one that we didn't investigate in detail, nor did we 9 investigate a lot of these in detail, but it's 10 certainly one that would be a viable thing to look at. l + 11 CHAIRMAN SELIN: All of the options except 12 the status quo have the federal government getting i i 13 more involved in non-AEA devices. I think there { 14 should be an option which says, you know, if you { 15 looked at the data and you could find no difference in 16 health effects between the AEA and the non-AEA l f 17 options, one conclusion would be that we could back 18 off the AEA options without expecting any detrimental 19 impact on health and safety. Although logically you ( 20 could say that's the limit to option 4 or option 5, in l 21 fact it's really a different option in my own view. j I 22 MR. VOLLMER: I think it is a different 23 option and I've got to go back to what ~I had said t 24 earlier, -that we tried to develop the options tol deal l + 25 with the problems as best we could determine them here i r NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 F1HODE ISLAND AVENUE N W. l <202) 2344433 W ASHINGTON. D C. 20005 (202) 234 4433 e Pi

56- .) l 1 and admittedly we didn't have enough and we don't have-i 2 enough information to tell, for example, if uniformity l 1 3 of application at the user level is a real problem. j 4 lf it weren't, then that type of an option would be j s I 5 very attractive for a lot of reasons. 6 COMMISSIONER de PLANQUE: Just more or i 7 less on that point, one of the reasons we're here and I 8 we're dealing with this is, is there a problem to 9 begin with in terms of public health and safety, and' { 10 one of your original conclusions was we don't have l f 11 enough data to definitively say there is not, if I can i 12 characterize it that way. i r 13 If you look at the options that you've l l 14 presented here or e.in some additional options,_how ~! I 15 would tne problem of having enough data to show the-i 16 effectiveness of the program be addressed in any of t i 17 those options? Or would you wind up with a worse j 18 situation? [ 19 MR. VOLLMER: If I understand your -{ t 20 question, Commissioner -- ( 'I 'l 21 COMMISSIONER de PLANQUE: We're where we 22 are because we're not sure we have enough de*a to say l L 23 definitively we've got programs that protect the l i 24 public health and safety. j t 25 MR. VOLLMER: I think in a couple of areas i NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS-t 1323 RHODE ISLAN' AVENUE. N W (202; 2444433 WASHINGTON, D C. 20005 (202) 2344433 }

57 1 we've said that we are . gathering additional 2 information that will be helpful. We're doing a i 3 number of things that will be helpful and I think i 4 we're -- I 5 COhnISSIONER de PLANQUE: That's not my j i 6 question. If you went to any of the other options, do 'l t 7 you then produce again the same problem of not being l 8 able to gather enough data to definitively say that [ 9 those options are effective? j 10 MR. VOLLMER: Well, if we went to option j h 11 2 or 3, Josie is pointing out that in the conclusion 12 section -- where are we? 13 COMMISSIONER de PLANQUE: Unless you get. 14 involved with repo'rting requirements, then you're left j i 15 with the same fundamental problem. You don't have any { 16 information to evaluate the system. Is that a 17 reasonable interpretation? i 18 MR. VOLLMER: I'think what we were trying l 19 to say is that there should be independent -- I mean, 20 before you go to any of the options -- data collected. f { i 21 That's clear. 22 COMMISSIONER de PLANQUE: I would agree f ? 23 with.that entirely. -l 24 MR. VOLLMER: Okay. 25 COMMISS10NER de PLANQUE: I'm just looking f NEAL R. GROSS l COURT REPORTERS AND TRANSCR:BERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON. D C. 2000$ (202) 234-4433

r ~*- 58 j 1 1 further down the road. If you were to even entertain 5 2

• he possibility of these options, have you done e

i i 3 anything to solve that initial problem? Would you -- I t MR. VOLLMER: I don't think we---- l 5 l COMMISSIONER de PLANQUE: -- if you made } 6 any of those options the new system? l l 7 MR. VOLLMER: Well', all-of these options, i 8 I think, could specify that you would be collecting i i 9 information as you went along and as part of the 10 requirements set by the federal government or whoever i 11 sets them that you would get this information. So i. 12 from that point of view it would, but in advance you 13 wouldn't necessarily have that information available. ~ ? 14 COMMISSIONER de PLANQUE: Correct, but in 15 or r'to answer the same question we're trying to i 16 answer now you would indeed have to do that sort of l l'7 thing. 18 MR. VOLLMER: Yes. 19 MR. NORELIUS: I might just add a thought. { r 20 that it may not be necessary to establish a full 21 database to answer the question. 22 COMMISSIONER de PLANQUE: I would agree. 23 MR. NORELIUS: There might be other 24 studies that you could 'do that would be statistical or l 25 limited in nature which would give you sufficient I NEAL R. GROSS COURT REPORTERS AND TRANSCReERS '323 RHODE ISLAND AVENUE. N.W. (202) 234-4433 WASHINGTON. D C. 20005 (202) 234 4433

. ~. - - - i 59 t information so that you may not come to the conclusion { 1 l 2 that you need a full database. l 3 l COMMISSIONER de PLANQUE: Yes. i 4 l MR. NORELIUS: Although the regulations f i 5 ! could provide that in any of these other options. i I l 6 ! COMMISSIONER de PLANQUE: Well, this is' f l 7 also connected with Commissioner Rogers' questioning l 8 earlier. If you're looking at effectiveness in the. 9 j full sense of the word, it doesn't necessarily make I I 1 \\ sense to spend a lot of resources so that you have 100 l 10 i l 11 percent of the data. You can make conclusions with a i f lesser amount. 12 i 13 MR. NORELIUS: Yes, that's correct. 14 MR. VOLLMER: (Slide) Okay. Finally we, j 15 on the last

slide, slide 16, conclude that the j

16 framework currently in effect should ' be maintained i 17 until current initiatives produce results and more 18 definitive data on the magnitude of the problem, until 19 that data is available, data on the magnitude of the 20-problem. Again, as Chuck had indicated, when we talk 21 about it in the report we don't necessarily think it l i 22 is cost effective to barge into a tremendous. data 23 gathering mode, particularly since there's.no real i 24 mechanism to get.it anyway at this point in time. 25 We think tnat there could be some clever NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. Q) 2344433 WASHINGTON. D C 20005 (202) 2344433 .. ~,

.~ .i 60 1 and very careful but fairly scientific ways of l 2 collecting good data to give you a good sense of if l 3 there are areas in this overall scheme of regulation j i 4 that are weak in terms of weak in the sense that 5 they're affecting the public health and safety and i 6 then you could focus your attention on that. Perhaps l 7 you won't be able to identify it, but I think you 8 would get a sense of what it might be from a careful 9 selection of data. ? 10 That concludes the task force report. l t i 11 Anybody else have anything to add right 12 now? i i 13 Then, we can open it for questions. j l 14 CHAIRMAN SELIN: I'd like to respond to l 15 the material. My overall conclusion is we don't have 16 as much information as we need at this point to even j 17 have laid out what the options are and what has to be l 18 done and I'll sort of tell you what I think are the l 19 holes, might have a little discussion. It's not j 20 guidance. It's more of a round table at this point. l 21 First of all, the interviews that you j 22 conducted turn out to be much more interesting than I 23 would have expected a couple of months ago, but that-24 sharpens the need to have a broader set of interviews. 25 You put more weight on them. You're effectively NEAL R. GROSS j COURT REPORTERS AND TRANSCRIBERS I 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON, D C. 20005 (202) 234-4433

61 ? I 1 asking us to put more weight on them than I would have l 2 expected and so I do believe we need a more balanced i i 3 set of interviews which I'm afraid that even the j 4 Federal Recister would be hard to do in a reasonable 5 amount of time, but it might even be a short way of i I 6 getting notice. But in any effect, there are j t i 7 organizations and there are consumer advocates within 8 states. Almost every state government we deal with I t 9 has another side that we could do. I So without saying how to do it, I believe, f 10 { 11 mostly because you've shown how productive those f 12 interviews can be, that we need a broader set of i 13 interviews. On behalf of the Commission, I think it's { 14 clear the Commission did not encourage you or did not j 15 give you either the time or the tools to get those, ( 16 but in retrospect I think we need those. j 4 i 17 The second is I think you have to sharpen l t 18 the options. To me there are three options and they l 19 all have some variations, but most of the attention so l 20 f ar has been on extending therapy. So unless evidence 't E 21 shows up that says that we ought to talk about } 22 extending diagnostics, I don't think that should be -- l 23 you know, logically it's in there, but I think we i 24 ought to concentrate on things that we have some-t 25 reason to believe ought to.be done. t NEAL R. GROSS f COURT REPORTERS AfJD TRANSCRBERS t 1323 RHODE !$ LAND AVENUE, N W j G02) 234-4433 WASHINGTON. D C. 20005 (207) 2344 433 i i . ~..

l 62 1 The three options are to cut back, to stay 2 where we are, or to go to a full approach. Now maybe 3 there's a fourth one which would be to extend the 4. standard setting so that all therapeutic radiation was I I 5 treated the same but at a lower level of federal 6 h inspection than we have today. We may have to think tiit 7 i about that. 8 But you've talked to enough people. I l 9 h don't think you should be constrained by just saying 10 we have a logically complete set. I think you really 11 l have to make some judgements as to which are possible i 12 ! and which not. And I wouldn't put too much stress on 13 the options because you've pointed out the data 14 problem, but as I go through the argument you'll see 15 why I think it's necessary to have the options. The third is to pick up the point that all 16 i l 17 l commissioners have really made but to go a-step 18 further. It's not enough just to say the data aren't 19 there. I think you have to say what data do we have 20 now and furthermore, to follow-up on Commissioner de 21 Planque's point, what data do you need in order to 22 decide on whether an optian is a good idea. Instead. l of saying let's collect all the data in the world and 23 24 go back and see what we hn e, you have to do a little 25 bit of backward experimentation. If such and such is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE?.UE. N W 1202) 234 4 433 WASHINGTON, D C. 20005 (202) 2344433

e 1 63 b ~* i i i 1 -j the option, what data would we need to decide if h t 2 l that's a good option or not? You can't collect it in i i 1 3 this time. l 4 And the fourth comment I'll nake is that 5 I think it's more in the phrasing, you know, in the j deference that you've paid to the Commission, but the 6 i i 7 language is too passive. I mean, there aren't going j 8 to be more data unless we go out to get them, so to 9 talk as if we should sit back until more data are j f 10 available really begs the question. The question is, l 11 what do you think the Commission ought to do in the 12 way of going out and collecting the data? Do you 13 think it's worth -- I mean, you can't answer this yet, l 1 14 but, when you start addressing what data are needed, i l 15 I think you ought to be saying do you think it's worth j i 16 collecting all this data. Are there steps that can be i i 17 done that are intermediate? l i 18 I just think that there has to be a little s i

well, first of all, l

19 more of an action-oriented l 20 there has to be a broader representation of the 21 opinions. The second is, I think the options have to l 22 be sharper. And then the third is, I think there has-23 to be some more action-oriented so we know what to do 24 with the work. 25 In any event, those are ny reactions to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W C21234 4433 WASHINGTON. D C. 20005 (202) 2344433

1 64 f 1 what's tnere now. They're really put on the table to 2 discuss so that when the Commission decides what to j i 3 instruct you to do we can have some feedback from you ] 4 rather than -- this is not a first guess as to what 5 we'll ask you to do, but my personal' reactions are we-6 need some information in this way. How hard would it [ f 7 be? Does it make sense to try to do? 8 But I think it may be useful to go around 9 and see what each of the Commissioners have to say and i 10 then try to react to whatever they say. l t i 11 MR. VOLLMER:

Okay, i

12 CHAIRMAN SELIN: Commissioner Rogers? l ) 13 COMMISSIONER ROGERS: Well, it seems to me 14 that the reason we got into this was a request from i 4 15 Senator Glenn that we give him some thoughts. And the 16 thoughts, it seems to me, are thoughts for the nation, j 17 not just thoughts for NRC. And while you have dodged j 18 the question, when you say federal authority you 19 haven't said who it is. We've sort of automatically 20 thought you were talking about NRC until you corrected 21 that and made sure that it wasn't necessarily NRC. 22 The breadth of your considerations came out a little 23 bit more clearly. 24 But my point is that if we were just 25 talking about NRC I think there's one point of view we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS '323 RHODE ISLAND AVENUE. N W. . GD2) 2344433 WASHINGTON. D C. 20005 (202) 2344433 -r m a w -e

65 .f l' might take. But if we're talking about a set 'of 2 recommendations to be of fered to Senator Glenn or not 3 even recommendations but just a perception of options, i 4 let's put it that way. I think that's probably a -j t 5 better way to put it. I don't know that we should l! t 6 make a recommendation. I think what we ought to be 7 doing is providing some, through our own expertise and 8 efforts what seem to be options, without necessarily l f 9 any specific recommendation of a particular option I 10 other than perhaps an observation that there's not { 11 enough data available to really make a good choice at-12 this point. That might be a consideration. 13 But in addressing the data _ question, first i i 14 I was a little bit concerned about the statement in i 15 your report that the states in general, as well as 16 some respondents from other sectors did not see the a ? 17 need for collecting additional data and making health .i 18 and safety comparisons and so on, to what the rest of 19 the sentence is in the report. 20 It_seems to me that the basis for their 'f 21 believing that no more data is necessary is that they f } 22 feel that public health and safety is being adequately ) 23 protected in the use of radiation. I think there's l 24 some questions about whether adequate data really i 25 exists to convince everybody of that, but that's one 'l .i I NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W. ac?) 2M*33 WASHINGTON. D C 20005 I202) 234 4 33 I i

-.. ~. i I 66' ) J 1 aspect of collection of adequate data. 1 2 It seems to me the other one though comes j l 3 to this question of ef fective program. That concerns-4 the use of resources. We could be spending enormous j 5 amount of time, effort and money to protect public 6 health and safety in a very inef ficient way and public 7 health and safety gets demonstrated that it is indeed-1 8 being protected. But that, it would seem to me, is 9 not the only question and therefore the central 10 question -- I think I might differ slightly with the j i 11 Chairman on the central question being as you've l .i 12 stated it, whether public health and safety is being j i 13 adequately protected. That was on slide 5. It seems 14 to me that the question of with a reasonable i 15 expenditure of resources is an issue and that in the 16 collection of data I would like to see a suggestion 17 that data be collected on precisely that aspect of i 18 this. Are resources being used effectively in I 19 ensuring public health and safety where it is being i 20 ensured? If it isn't being ensured, what would be the i 21 required additional resources that might be needed? { 22 But it seems to me to take a kind of l 23 prophylactic view of this from the standpoint of f 24 economics is a mistake, that resources are very J 25 determinative of what we do always. The notion that l l 1 NEAL R. GROSS t COURT REPORTERS AND TRANSCRIBERS '323 RHODE ISLAND AVENUE. N W l 1202) 234 4 433 WASHINGTON. O C. 20005 (202) 234 4433

. - ~ -.. .- ~. .t 67 I 1., resources are irrelevant to this question is having il i 2b . tunnel vision. Resources are fundamental to what one il 3 can accomplish and perhaps NRC's concerns are not 4 il primarily with resources, but if we're making a b 5 ;; recommendation as to what one ought to focus on here t \\ for somebody else's consideration, then I certainly 6 ! i f would opt for including in that the use of resources, 7 i 8 data on the use of resources. We've heard about that i l a 9 from our own ACMUI at great length of how regulations p 10 and regulatory practice impacts on their ability to do i 11 their jobs because the regulation eats up resources. l 12 I don't know that I necessarily agree with them, but 13 it's certainly an issue and I would expect that it's 14 an issue in other areas as well. j l 15 i So, my point here is that I don't think 16 the central question is solely adequate protection. l l i 17 I think there is this effectiveness question that we = 18 talked about a little bit earlier that also ought to l be in there when one talks about collecting data. I j 19 i 20 would hope that that is something that we include in l 21 our elucidation of the kinds of data that need to be 22 collected. 23 MR. VOLLMER:

Well, without making 24 excuses, I think perhaps the report might have come 25 out somewhat stilted in some of these areas, but I can i

NEAL R. GROSS 1 COURT REPORTERS AND TRANSCRIBERS - i 1323 RHODE ISLAND AVENUE. N W l f 202) 2344433 WASHINGTON. D C 20005 (202) 2344433 i

t 68 1 assure you that the task force has that in mind and to 2 think about that because -- r 3 COMMISSIONER ROGERS: I think it needs to 4 be clearly obvious in -- i 5 MR. VOLLMER: we recognize, for 6 example, in talking to others that -- some would argue 7 that radiation medicine is the safest thing you can.do 8 in the hospital environment and maybe that's right. 9 I personally don't know one way or the other. But I i 10 think it's been made clear to us that the treatment 11 modalities and different -- when you look at the 12 spectrum of things, what you focus on is how much you t 13 have to apply to get adequate protection. 14 Now, I personally from the after side sort 15 of build that in when I look at a/ quate protection, ] 16 I look at cost beneficial if you made it a basic 17 requirement of safety. I'm not trying to do that to I 18 get the rest of the task force involved in that. i 19 COMMISSIONER ROGERS: I would say that I ) 20 don't think that comes through clearly enough in the 21 report. 22 MR. VOLLMER: But we do agree with that as 23 being an important aspect. 24 COMMISSIONER ROGERS:. The objection to 25 collecting more data seems to be that you. don't'need NEAL R. GROSS COURT RE PORTERS AND TRANSCRIDERS 1323 HHODE ISLAND AVENUE, N W. [202) 234 4433 WASHINGTON. D.C 20005 (202) 234-4433

.i 69 1 it to. demonstrate that adequate health and safety is l 2 being assured. It seems to me there's another reason j 3 for collecting data, that it's boing ef fectively 4 assured. 5 The other point that I'd make is that I { 6 agree with the Chairman that it seems to me there are 7 other options here that perhaps need to be identified 8 a little bit. I was looking for them beyond what was 9 here and I didn't see them. But I think that the t 10 discussion today has in my mind clarified a little bit { 11 what your thinking was in back of these options. In i 12 your description, Dick, of what was being involved, l l 13 because I'd focus on your introduction of the notion l i f 14 of the discriminator setting, it seems to me that's a 15 very important aspect of what's involved in your j 16 thinking here that within each of these options where 17 you set the discriminator determines really a 18 qualitative difference in some ways as to how one of 'l I 19 those options would actually work out. l 20 I think perhaps casting your observations 21 in a way that includes the notion of the discriminator l -i 22 setting in terms that a non-nuclear physicist-would j 23 appreciate, the significance of that, because I think 1 l 24 that to me it strikes home. I know exactly what you 6 l 25 nean when you say set the discriminator. I'm not sure ' NEAL R. GROSS - j COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AkENUE. N W. (2CD 2344433 W ASHINGTON. D C 2D005 (202) 234 4433 l

=. 70 1 that the full import of that is obvious to all. I 2 think it is an important part of your presentation 3 today as far as I'm concerned. i 4 MR. VOLLMER: It's a thing we did talk 1 5! about but couldn't deal with in terms of the-time to-I 6 produce this thing. 7 COMMISSIONER ROGERS: Yes. But somehow I i 8 the flavor of that I think is important. 9 t MR. VOLLMER: But it is something we did j 10 l talk about and how f ar should we go. We talk about it 1 in terms of Part 20, Part 35 and other parts of the 12 i regulations, where should you set it. 13 COMMISSIONER ROGERS: Yes. 14 MR. VOLLMER: But I must say the basic i 15 discriminator we set here was at the user level. -We i 1 16 just couldn't parse it out any better than that right j i 17 now. 18 COMMISSIONER REMICK: A couple-comments ) 19 and a couple questions. 20 I think the Commission gave you a very j 21 difficult if not impossible task becadse of the time 22 limit, but it was something that needed to be done and i 23 I think you've done a good job of identifying some of l 24 the options. I agree with some of the comments made 25' earlier that there are probably other options.- The i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, NLW (202) 234 4433 WASHINGTON. O C, 20005 (202) 234-4433

~ I 71 I one the Chairman identified I think is one. I don't 2 think that's so important at this time. We have a i 3 number of efforts going on here. We had a need for 4 this because of a commitment made to Senator Glenn, 5 but we have a number of other things going on in-6 parallel and I don't want to take the thunder of what l 7 I think Commissioner de Planque might be thinking 3 about because she keeps reminding us of getting a l 9 coordinated effort in these various things that we're 4 10 ; doing. I 11 But I really look -- I might be wrong, but 12 I'm looking to the National Academy of Sciences to I t j 13 look at the various options and come up with some 14 strong recommendations on which ones from their 15 perspective they think we should follow. So, I think 16 it's premature at this time to be thinking about which 1 17 one of these we go. We have a number of things we're 18 doing and in my mind a very important one is that 19 independent National Academy of Science which will 20 look at various options and might come up with ones we l 21 haven't even thought of that we'll have to consider. 22 The. goes along with the Chairman's 23 comment. I agree we need more input from different f. 24 groups, but I'm not sure when we do that. It might be 25 premature now because once we have the National' f NEAL R. GROSS COURT REPORTERS AND TAANSCR182RS 1323 RHODE ISLAND AVENUE. N W. - (202)2344433 WASHINGTON. O C. 2D305 (202) 2344433 i

1 72 1 1 1 Academy of Science's recommendations and if we decide 2 to follow one of those or some other course, then I f 3 think is the time we need very broad input on the path ] 4 that we might have picked out to proceed on. I'm not 5 against getting the public input before, but I think J 6 it's going to be necessary and very important at that 7 stage. 8 A couple questions. I should know this j l 9 one. Perhaps I'm embarrassed to even ask it on the i 10 question of pacemakers. What role does the NRC play i 11 in regulating materials in pacemakers? 12 MR. NORELIUS: We have evaluated those 13 devices in the past for radiological safety purposes, 14 issued licenses authorizing their implantation and 1 15 follow-up of patients and inspected them as we.do 16 other items. 1 17 COMMISSIONER REMICK: Okay. I'm thinking 18 more of the FDA/NRC MOU right now because there are j 1 19 materials other than byproduct material involved. l 20 Most of that NRC/FDA MOU talks about byproduct 1 21 material. j 22 Another interesting question comes _ to 23 mind. If we look to boron neutron capture therapy, is .24 the reactor a device in that case? The neutrons are 25 non-ionizing radiation. So, we talk about only NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE (SLAND AVENUE, N W. (202) 2344433 WASHINGTON, D C, 20005 (202) 2344433 ~l o

i i i 73 1 ionizing radiation. Boron is not a byproduct 2 material. Have you thought about that in the wording l 3 of the MOU? That's not our discussion today. I'm 4 throwing this out. I've asked for a staff briefing 5 tomorrow to explore some of those. But when we think l 6 about that MOU, I think we're thinking just about 7 byproduct material now and maybe we have to be i 8 thinking just a little bit more broadly, i l 9 MR. TAYLOR: That's a good point, sir. 10 Let me look at that. 11 COMMISSIONER REMICK: I've asked for a 12 I staff discussion tomorrow on that very subject. i 13 MR. TAY LOR: On that subject? Okay. 14 COMMISSIONER REMICK: That's all I have, i 15 Mr. Chairman. 16 CHAIRMAN SELIN: Commissioner de Planque? [ l i 17 COMMISSIONER de PLANQUE: Yes. I want to s i 18 congratulate you on the job that you did. I agree it j 19 was somewhat of an impossible job and you had to 20 navigate through many alligators in the river to get l 21 from there to here. So, I think you did an excellent i 22 job and certainly within the time that you had I think 23 the product is very good. 24 MR. VOLLMER: Well, thank you. You're 25 looking at the folks who did it. We appreciate it. NEAL R. GROSS COURT AEPORTERS AND TRAtdSCRIBERS i 1323 PHOD - ISLAND AVENUE. N W. 1202) 234-4433 V. AJ ilNGTON. D C. 20005 (202) 2344433 { t

.I l 74 1 COMMISSIONER de. PIANQUE: I guess one of 2 my basic philosophies is if it ain't broke don't fix 3 it. So, I get back to the original problem of is it ) i l broke, which brings me back to the discussion of the 4 i 5 database. You've clearly said here that we don't have f i 6 enough data to definitively say we're not negatively i l 7 impacting the health and safety. I still have an i 8 uneasy feeling that we don't have a handle yet on what j i 9 the uncertainty is in the data that we already have. l i I 10 You certainly don't need 100 percent data in order to 3 11 be able to make an assessment. Statisticians have 12 made a career out of using less than 100 percent of 13 the data, but at assessing the uncertainty or how much I i 14 better you're likely to get the data and how much more l 15 improvement will you have if you do get closer to 100. I 2 16 percent of the data. 17 I would assume in the time given that you i 18 really didn't have a chance to look at this, or did i 19 you? l 20 MR. VOLLMER: No, we did not. 21 COMMISSIONER de PLANQUE: Okay. To me l 22 it's still somewhat of a critical issue because we're 23 not sure yet how much data would you really need to be 24 more comfortable in your statement. l l 25 MR. VOLLMER: We talked about it sort of l I t NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS u?3 RHOcc ISLAND AVENUE. N W. l (202) 2344433 WASHINGTON D C. 2000$. (202) 234 4433 i ( I

.u m .u_._, .__.2 m s a t. I 75 l 1 qualitatively. ( I i 2 ! COMMISSIONER de PLANQUE: Yes. t ( I 3 l MR. VOLLMER: Certain areas we're j [ i 4 i comfortable in and certain areas we weren't and we C i 3 5 l recognize that we didn't have to collect all the data l I e 6 l we had identified in the appendix by a large margin. j l 7 It was the types of data we felt might be needed, but 8 not necessarily a full collection. But I agree with l 9 ; you that we could go a good step if we set our mind to t i 10 I that as a task and we have not done that. l 11 COMMISSIONER de PLANQUE: Yes. And you l u 12 certainly can take data and say, "Well, how uncertain l l 13 is it? How much of an error might we be making l i 14 looking at what we already have?" r 15 MR. TELFORD: I would like to note that in } 16 the list of issues that we sent out, this is in - 1 17 Appendix B to thc report -- l i 18 COMMISSIONER de PLANQUE: Yes. l 5 19 MR. TELFORD: -- in the area of data and 20 health effects. I believe for each of these items i 21 you'll see at the end, "And the uncertainty on each 22 estimate." i 23 i COMMISSIONER de PLANQUE: Exactly. l 24 MR. TELFORD: So, the task force 25 identified that and agrees with you. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j 1323 BHODE ISLAND AVENUE, N W l (2 2)2344433 WASHINGTON, D C. 20005 1202) 2344433

76 I I 1 COMMISSIONER de PLANQUE:- Yes. Yes. } 2 Okay. And for me it's hard to even entertain 3 particular options until you really have a feel for is i 4 it broke because if you know it's broke, then you have ] 5 to figure out why it's broke and then see if any of 6 the options you've suggested will address that l [ 7 particular problem. j i l 8 Just one additional comment on p 9 Commissioner Rogers' resources and effectiveness. I l l 1 10 see that we addressed data collection in many areas l 11 and a lot of it to me looks at indirect measures of L 12 what we're really looking for and in this case we're ] 13 looking for is the public health and safety in 14 jeopardy in any way. We do a lot of indirect measures j 15 like numbers of backlog on licenses, numbers of people 16 and that sort of thing and maybe not enough on the 17 other side of the coin, what's the real harm, what's j a 18 the real issue here. So, that's clearly part and ) t } 19 parcel. } [ a 1 20 MR. VOLU4ER: Even misadministrations has j 21 not necessarily direct corollary with harm and that's l l 22 another issue that we just couldn't really address. l 23 COMMISSIONER de PIJd1QUE: No. Okay. 24 That's all I have, but I do congratulate you on an j i 25 excellent job in a short period of time. l 1 1 NEAL R. GROSS 1 COURT REPORTERS AND TRANSCR$ERS 1323 RHODE ISLAND AVENUEm NW 202) 234-4433 WASHINGTON. O C. 20005 (202) 234-4433 ~{

77 f 1 MR. VOLLMER: Thank you. .t f 2 CHAIRMAN SELIN: Mr. Vollmer, did you want i e 3 to add anything now that you've heard some of this t 4 discussion? I 5 MR. VOLLMER: Well, I think the issue on 6 the recommendations, I guess we perhaps took a very l 7 narrow view of trying to focus on what the Commission j t 8 wanted in that area. We recognize that none of the t 9 options that we could think of except the going-10 forward and getting a better handle on the problem i i 11 were really viable at this time. So, perhaps we've 1 l 12 been better served just to talk about the one and not 13 list the other. But we did put the others down just l l 14 as ways that we felt could solve some of the perceived j 15 issues that are out there and we just don't know if f 16 they're real issues or not yet. t 17 But I think the comments the Commission i 18 made we appreciate. I think we've found this a l 19 challenging and interesting job and some of the things .l 20 you've brought up were questions that we felt were 21 important to address and should be addressed to reach 22 a conclusion on this for yourselves and for anybody 23 else that's interested in this field. So, we 1 24 appreciate the feedback. 1 1 25 MR. TAYLOR: I would think the staff needs l i l NEAL R. GROSS -l COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) ?34 4 433 W A$HINGTON, O C. 20D05 -(202) 2344433

78 j i 1 to understand-whether you would like this task force l 2 to continue, delve into the availability of data, such l 3 as it is, even to and including linear accelerator l .g f 4 applications at the user end, if it's available, and f 5 pursue some of the issues that have been outlined i 6 here. I presume from the comments that it's the 7 intent of the Commission that we continue. r i 8 CHAIRMAN SELIN: Don't assume that. The .i 9 Commission has got to discuss that. But let me just l 10 go back to the history because I think the history has f I. 11 been miscast here a little bit. l \\ 12 Number one, we had

intended, we the-13 Commission, to look at these issues before we 14 testified to Senator Glenn.

He asked for an interin 1 15 report but this is part of the Commission's business, l 16 not just to meet a one shot requirement. It has many f 17 objectives and that's one of them and that still i 18 remains valid. l -l 19 The second is it was never intended that j i 20 you make a preliminary recommendation on the options. i 21 The whole idea was to do a meta analysis to. lay out i l 22 what would have to be known and what is known-.today 23 for another group, perhaps the National Academy group, 24 to come to some conclusion. So, we never asked you to 25 choose and the whole reason for defining options which [ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202)234 4433 WASHINGTON, D C. 20005 (202) 234-4433 I ~

79 e 'l may or may not have been well conceived was that i I 2 before we asked you things like are the data adequate, 3 you'd have to say, "To decide what?" So, this is not a substitute for the 4 H 5l National Academy group or any other group. It was l 6 more to get at the work. In fact, I think you've } 7 proved that useful because if in fact the data are not 8 adequate to support such an analysis, then convening l 9 a big group and having them come in two years later l 10 j and say the data are not adequate to support the h 11 analysis would probably be a situation we'd like to i 12 avoid. 13 So, the Commission's deliberations on 14 wheiher to continue the task force will not be can you 15 do what the h tional Academy group could do two years j 16 in advance, but by having the task force continue l l 17 could we get some things out of the way so that the i 18 other groups could prosper? I think that's the key i 19 question. l 20 I also weald like, of course, to support l l 21 Commissioner Rogers' point about resources. I didn't 22 mean to leave that out. We could have a program -- l ? 23 you know, the Department of Health in New York City f 24 might order every apartment to buy a plant, the 25 wolfsbane plant and then two years later prove that ) 4 j NEAL R. GROSS l COURT REPORTERS Af4D TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W j w-n wASwua,oN.D e m s amun T v ,e---

i + 80 i i 1 nobody had been attacked in an apartment by a wolf and } i 2 therefore they'have an effective program. So, that's j f 3 clearly not the kind of thing that we're looking for. i 4 We need to talk among.ourselves and the 5 real question I had for you, is there anything else j P 6 that you thought would be useful for our deliberations .f 7 before the Commission comes back together to tell. you -t 8 what we'd like you to do next? ? 9 MR. VOLLMER: No, sir. 10 CHAIRMAN SELIN: Commissioners, any other j l 11 comments? Fine. 12 Thank you very much. 3 13 COMMISSIONER ROGERS: Thank you very much. 14 (Whereupon, at 11:43 a.m., the above-15 entitled matter was concluded.) r 16 i 17 i 18 19 9 20 l 21 l 1 22 23 a 24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. j I2:T2) 234-4433 .. WASHINGTON. D C. 20005 (2C2) 234-4433

1. 1 CERTIFICATE OF TRANSCRIBER This is to certify that the attached events of a meeting i of the United States Nuclear Regulatory Commission entitled: I TITLE OF MEETING: BRIEFING ON INTERNAL MANAGEMENT REVIEW OF NRC PROGRAM FOR MEDICAL USE OF BYPRODUCT MATERIAL i PLACE OF MEETINC: ROCKVILLE. MARYLAND DATE OF MEETING: JULY 29, 1993 were transcribed by me. I further certify that saidtranscriptken f f is accurate and complete, to the best of my ability, and that the transcript is a true and accurate record of the foregoing events. I i .n. n '? ).C ( (~}U .) i Reporter's name: Peter Lynch e 4 i I l HEAL R. GROSS cover escoarses Aus inAuscamens 1333 RM000 #ELawB AV5wWE. N.W. (202) 234 4433 WASM386704. O C. 2000$ (202) 232-8000 l 3 i

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t w4{.%- &*g g 'Yl% Y'+n 4 %k+4 TASK FORCE REPORT ON MEDICAL RADIATION PROTECTION OPP-93-04 Revision 1 COMMISSION BRIEFING JULY 29,1993 7/29/93 i

BACKGROUND e SENATE GOVERNMENTAL AFFAIRS COMMITTEE HEARING ON MAY 6,1993 e REQUEST FOR PRELIMINARY REPORT e TASK FORCE GUIDANCE FROM EDO ON MAY 17 e MAY 20 CRCPD MEETING e COMMISSION GUIDANCE PROVIDED ON JUNE 10

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O CURRENT REGULATORY FRAMEWORK e NRC CONTROL LIMITED TO BYPRODUCT MATERIAL (~ 25% OF THERAPY? - REPORTS REQUIRED OF MISADMINISTRATION BY USER FDA CONTROL COVERS ALL DEVICES AND DRUGS AT MANUFACTURER - REPORTS REQUIRED OF DEATH OR SERIOUS INJURY l (

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CURRENT REGULATORY FRAMEWORK e STATES HAVE BROAD PUBLIC HEALTH RESPONSIBILITIES BUT IMPLEMENTATION FOR MEDICAL RADIATION VARIES WIDELY - NRC AGREEMENT STATES HAVE COMPATIBLE PROGRAMS BUT IMPLEMENTATION LAGS NRC LICENSEES - MOST AGREEMENT STATES EXERCISE SIMILAR CONTROLS OVER NON-BYPRODUCT MATERIALS - PROGRAMS IN NON-AGREEMENT STATES VARY

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APPROACH AND DEVELOPMENT OF ISSUES DEVELOPMENT OF CENTRAL QUESTION RELATED ISSUES OBTAIN INPUT FROM STAKEHOLDERS PRINCIPAL FINDINGS CHARACTERIZATION OF PROBLEM PRELIMINARY OPTIONS

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CENTRAL QUESTION DOES THE CURRENT ALLOCATION OF AUTHORITY AND RESPONSIBILITY AMONG FEDERAL AND STATE REGULATORY BODIES MEET THE NATIONWIDE GOAL OF ENSURING ADEQUATE PROTECTION OF THE RADIOLOGICAL HEALTH AND SAFETY OF THE PUBLIC, INCLUDING PATIENTS AND HEALTH CARE WORKERS, FROM ALL SOURCES OF IONIZING RADIATION USED IN MEDICINE?

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CATEGORIZATION OF RELATED ISSUES UNIFORMITY OF REQUIREMENTS AND REGULATORY OVERSIGHT e DATABASE AND HEALTH AND SAFETY IMPLICATIONS TRAINING AND EXPERIENCE CRITERIA COMMUNICATION AMONG FEDERAL AND STATE AGENCIES

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CONTACT LIST 4 STATES NRC ADVISORY COMMITTEE ON MEDICAL USES OF - ISOTOPES FEDERAL REGUL ATORY AGENCIES FEDERAL MEDICAL LICENSEES PROFESSIONAL SOCIETIES MEDICAL EQUIPMENT AND RADIOPHARMACEUTICAL MANUFACTURERS. 4 VOLUNTARY HEALTH ORGANIZATION

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PRINCIPAL FINDINGS CURRENT REGULATORY FRAMEWORK INCONSISTENCIES - POTENTIAL TO ADVERSELY AFFECT ADEQUACY OF RADIATION PROTECTION INFORMATION NOT CURRENTLY AVAILABLE FOR ALL USES OF IONIZING RADIATION TO DETERMINE l IF THERE IS A HEALTH AND SAFETY PROBLEM l l t

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PRINCIPAL FINDINGS IMPROVEMENTS COULD BE MADE WITHIN EXISTING REGULATORY FRAMEWORK - INTERNAL AGENCY STUDIES - NRC/FDA MEMORANDUM OF UNDERSTANDING - NATIONAL ACADEMY OF SCIENCES STUDY DESPITE LACK OF DATA, NOT CLEAR THAT HEALTH AND SAFETY NOT ADEQUATELY PROTECTED

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4 0 CHARACTERIZATION OF THE PROBLEM A LACK OF A FULLY COORDINATED REGULATORY EFFORT AS WELL AS A LACK OF SUFFICIENT DATA TO EVALUATE THE EFFECTIVENESS OF THE EFFORT, ACROSS FEDERAL AND STATE AGENCIES, TO ENSURE ADEQUATE PROTECTION

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O P PRELIMINARY OPTIONS

1. MAINTAIN THE CURRENT FRAMEWOR( FOR THE REGULATION OF MEDICAL IONIZING RADIATION, WITH RECOGNITION OF THE PLANNED AND POTENTIAL IMPROVEMENTS

- AGENCIES CONTINUE IN CURRENT ROLES - ACCOMMODATES ONGOING INITIATIVES TO IMPROVE REGULATORY OVERSIGHT - DOES NOT ADDRESS FRAGMENTATION AND INCONSISTENCIES FOR NON-AEA MATERIAL AT STATE LEVEL

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( F PRELIMINARY OPTIONS

2. THE FEDERAL GOVERNMENT DEVELOPS AND IMPLEMENTS REGULATIONS THROUGH AN AGREEMENT STATE-LIKE PROGRAM FOR ALL SOURCES OF IONIZING RADIATION USED IN MEDICAL THERAPY

- PROVIDES UNIFORMITY, CONSISTENCY, AND AVOIDS GAPS IN RADIATION THERAPY - ACCOMMODATES AN AGREEMENT STATE PROGRAM - REQUIRES LEGISLATION AND INCREASES FEDERAL COST - REDUCES STATE AUTHORITY

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9 PRELIMINARY OPTIONS

3. THE FEDERAL GOVERNMENT DEVELOPS AND IMPLEMENTS REGULATIONS, THROUGH AN AGREEMENT STATE-LIKE PROGRAM, FOR ALL SOURCES OF MEDICAL IONIZING RADIATION

- PROVIDES UNIFORMITY, CONSISTENCY, AND AVOIDS GAPS IN RADIATION MEDICINE - ACCOMMODATES AN AGREEMENT STATE PROGRAM - REQUIRES LEGISLATION AND MARKEDLY INCREASES FEDERAL COST - SIGNIFICANTLY REDUCES STATE AUTHORITY

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PRELIMINARY OPTIONS 1

4. THE FEDERAL GOVERNMENT DEVELOPS REGULATIONS FOR ALL SOURCES OF IONIZING RADIATION USED IN THERAPY WITH STATES RESPONSIBLE FOR IMPLEMENTATION

- PROVIDES UNIFORMITY, CONSISTENCY, AND AVOIDS GAPS IN THERAPY REGULATIONS - STATE FLEXIBILITY IN IMPLEMENTATION - REQUIRES LEGISLATION AND STATE FUNDING - DIFFERENCES IN PROGRAM IMPLEMENTATION - REDUCES STATE AUTHORITY l l

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t e PRELIMINARY OPTIONS

5. THE FEDERAL GOVERNMENT DEVELOPS REGULATIONS FOR ALL SOURCES OF MEDICAL IONIZING RADIATION WITH STATES RESPONSIBLE FOR IMPLEMENTATION

- PROVIDES UNIFORMITY, CONSISTENCY, AND AVOIDS GAPS IN REGULATIONS FOR RADIATION MEDICINE - STATE FLEXIBILITY IN IMPLEMENTATION - REQUIRES LEGISLATION & INCREASES FEDERAL & STATE COST - DIFFERENCES IN PROGRAM IMPLEMENTATION - REDUCES STATE AUTHORITY

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k g', 4-l CONCLUSION THEREFORE, WE CONCLUDE THAT THE REGULATORY FRAMEWORK CURRENTLY IN EFFECT FOR IONIZING MEDICAL RADIATION'SHOULD BE. MAINTAINED UNTIL CURRENT INITIATIVES PRODUCE RESULTS AND MORE DEFINITIVE DATA ON THE MAGNITUDE OF THE PROBLEM ARE-AVAILABLE 4 m

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