ML20033F028

Transcript of Annual Briefing on Medical Use of Byproduct Matl on 900220 in Rockville,Md.Pp 1-70.Viewgraphs Encl

ML20033F028
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Issue date:	02/20/1990
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REF-10CFR9.7 NUDOCS 9003150285
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g UNITED STATES OF. AMERICAL NUCLEAR REGULATOR-Y COMMIS SION F fkO*. ANNUAL BRIEFING ON MEDICAL USE OF BYPRODUCT MATERIAL q -LOCitiODl' ROCKVILLE, MARYLAND d h3(6 FEBRUARY 20, 1990-S Pages: 70 RAGES 6 is E.LR.GROSSANDCO.,INC. C o l' R i REPORTERS AND TRANSCRISERS 1323 Rhode Island Avenue, Northwest Washington, D.' C. 20005 (202) 234-4423 I O D 9003150285 900220 PDR 10CFR (1 PT9.7 PDC is

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-1 DISCLAIMER H This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on Februarv 20, 1990,' in the Commission's office at One J White Flint North, Rockville, Maryland. ,The mee ting -. was open to public attendance and observation, This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies. The transcript is intended solely for ' general informational purposes. As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in. this transcript do not necessarily reflect final determination or beliefs. No pleading or other' paper may be filed with ths Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the commission may authorize. 0 NEAL R. GROSS COURT Rf9oRTER$ AND TRANSCRIRERS 1323 rho 0f ISLAND AVENUf, N.W. (202) 234-4433 WASHINGTON, D.C. 20005 (202) 232-6600

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{; L.f ; f UNITED STATES-OF AMERICA NUCLEAR REGULATORY COMMISSION 4 E ANNUAL BRIEFING ON MEDICAL USE OF BYPRODUCT MATERIAL PUBLIC MEETING Nuclear Regulatory Commission One White Fljnt North Rockville, Maryland _ Tuesday, February 20, 1990 The Commission met in open session, pursuant to notice, at 2:00 p.m., Kenneth M. Carr, Chairman, presiding, f I COMMISSIONERS PRESENT: KENNETH M. CARR, Chairman of the Commission THOMAS.M. ROBERTS, Commissioner KENNETH C. ROGERS, Commissioner . JAMES R. CURTISS', Commissioner x y:

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v,.y, ',.;, w. o,e ;N -.. '" '&= ^ .t. :.. c _-l.g dA$.; t o 7 fl9 i rf~'. 90 - Q;;: 4,Sn - i ?~' y -. STAFF STATED'.AT THE-COMMISSION TAELE:. 2 r .:j+ p. b' -SAMUEL J. CHILK,. Secretary-3 i h WILLIAM C. PARLER, General-Counsel b;e - t h _q,1, [ JAMES TAYLOR, Executive Director. for' Operations: i R'0BERT-BERNERO, Director-of. Operations, NMSS 4 / NORMAN McELROY', - Sect ion Leader -Medical -and Academic Section.IMAB/NMSS' i !V ANDY MILLEb, c A/D for St at e Agreement s ' Program,- GPA: (r g t JOHN GLENN, Chief,' Medical and Commercial Use' Safet y B r a n c h, 1 M A ll / NM S S. JAMES-MYERS, IMAE/NMSS. ...,t c.- t.

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g-. s J r m I 1 p-R-0-C-E-F-Il-I-N-C-S e -C' 2:00 p.m. + b l '3-CHAIRMAN CARR Good a f t e rn os;. ; l'adies and, 4 g V '4: gentlemen. m t 5 This is the NRC staff's annual briefing. to - hg -G the Commission on the medical: use of byproduct-gs c 7 material. The purpose of.the' briefing ~ is for the n 8. staff to' provide 1 a programmatic overview of NRC's e, 9 rygul a t ory program-for medical ~uses of-byproduct g 10 - material. With more than 7,000 licensees. performing 11 over 7 m:illion clinical -procedures a year, the' medical ~ 12 use area is one of t he largest programs'for radicactive-J' 13-. mot. rial ti. 5, regulated by 'NRC and the agreement -14 atates. ~ fl T. Today's' briefing provides.an opportunity for 10 the Commission.to assess the status and effectiveness-17 of NRC's current. regulatory program to ensure.the ^18 sa fet y of ~ medical uses of byproduct material'.

19 C om'm i s s i o n e r Remick will not~ be with' us 20.

today.. -He's on travel. 21-Do any of.my fellow Commissioners have : any: 22 opening comments? 23 If not., Mr. Taylor, please proceed. 24-MR. TAYLOR: Good afternoon, sir. With me 2n nt th.. table from t h. O f fi ce of NMSS, to my left, Mr. hi B[ ' NEAL R. GROSS 1323 Rhode Island Avenue, N.W. r' W a s h i n g t o n', D.C. 20005 (202) 234-4433 i

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M3ers, John

G1enn, Dol

Bernero, the Office 4

2 Di rect or, Nor m McElroy, who I think you know, and Vandy Miller from the Office of State Programs. 4 The briefing today will discuss principally 5 the implementation of a five point program which the 6 staff previously submitted to the Commission in SECY-7 88-77 and will cover how the staff is trying to. 8 Improve its oversight of the medical uses of byproduct 9 mat erial. We'll cover some special interest topics in 10 that area and we'll briefly give you an overview in 11 the stuffing and budget allocations currently for that 12 program. 13-With that i nt roduct ion, T'll ask Mr. Glenn .a. 14 to proceed. 15 DOCTOR GLENN: Okay. Thank you very much. 1G (Slide) If I could have. - t he first slide, 17-plense. In There's four topics that I want to cover 19 today. The first one is just to briefly characterize 20 or recharacterize the medical use industry. The 21 second is to cover the medical use program, the five '22 points that we initiated in our paper in 1988. Then 23 some areas of concern in medical use. In some of-24 these cases, we anticipate problems and I guess in 25 s mo n thero are some opportunities. And then finally r i L NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Wanhingt on, D.C. 20005 (202) 234-4433

i l s' k is e E 5' .g. g. [ t .t 1 the-program resources will be the last topic that we 2 discuss. 3 (Slide) The next slide, please. 4 Just a quick few comment s on the industry. 5 Just to. remind you of some of the characteristics as G has already. been mentioned. There's seven million -i 7 diagnostic procedures a year and around 150,000 a 8 therapy. I guess one point I would like to make, of 0

course, is that the data we have in the medical 10 program is relatively soft compared to what maybe l

11 you're used to in the reactor program. This is data 12 that's inferred .from various

sources, articles, j

l 13 manuscripts and so forth. We don't have a hard count, ^ 'l 14 of

course, of how many procedures are actually 15 performed each year.

IG Another

point, I

guess, is that we're 17 regulating on1y a small part of the medical industry.

18 There are over 100 million admissions into a hospital l 1 19 per year and certainly major areas of a hospital are 20 not subject to our regulation. 1 21 There are approximately 2,200 hospitals that l i 22 have NRC licensees as well as 400 private practices. -l 23 Now, these numbers are hard because they come from our 24. license management system database. As a rule of i 1 25 thumb, there are usually -- we usually can' count on I I NEAI, R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 .I

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s .c> P n* C ., 3.. j ~ Jt h )i's ' b ei n g. ' a b o_u t -twice. as many agreement _ state I or 1" N l2-1 -i e e ris e e s as NHC licensees in this particular aren. -3L So, around,7,000Ltotal medical-licensees in.the Unite'd r y '4' S t.fi t O S. 'a t .t 5 (Slide)- The next slide,=please, j .i G This slide shows some data o n' ~~ 7: misadministrations that have beenLreported to the NRC 7-r 8 <over the last four~ years. 'I'm not going to go into a T 9 lot: of. det ail l ~ because on April-9th, AEOD will be -10 giving a: briefing to the Commission.and we'11ugo into 'p -11 some of-tbese findings in much more depth. 12 One thing I want to caution: is. not -t o make 3 +" '13 -major 4-asr.umptions' based on the data that.'s shown here. 14: There may appear to be-trends, but-they may not be y -t 15 . real 't rends. One :.poin t to: note.is that in calendar' la year '87 there -was a - change :in: -the reporting -17 requirements.r o r d i a gn o s t_ i c misadministrations.- So,, 18: what had t o-be reported. changed 7ust a=little bit:at. 19[ .t hat point .so there is'n~ discontinuity in the data at 20 that poknt. t 21 COMMISSIONER. ROGERS: Would' that affect s ( 22-the -'- might affect the '_87, '88 numbers, comparative 23-numbersior-when did that go into effect? M.' 24 DOCTOR GLENN: It actually went into effect ... fi in. April of 'R7. So, it would have nfrected -- '8G ~; 3,- l . Su :s NEAL R. GROSS 1323 Rhode Island Avenue, N.W. ~q' Washington, D.C. 20005 (202) 234-4433 a-

p- - 'n. y 1 pm l i l 1 would hose been totally under the old system,.'87 is a -2 mixed year and then '88 and '89 would be under the new 3 reporting requirements. In '89, although the year is 4 finished, we probably don' t have all the data in to 5 AEOD at this point. So, that number will probably' 6 increase. 7

Now, if you notice, we broke it out into 8

three categories, diagnostic, iodine 131 and. therapy. 1 0 They're not reported in that fashion. They're 10 ' reported e i t he,r as diagnostic or therapy. It did 11 .brenk out the iodine 131 as being of interest because 12 although some of those misadministrations a r e. 13 diagnostic, b e c a u s:. e iodine is involved and a small 14 amount of iodine going to.the thyroid results in a 15 very-large

dose, we're more concerned about 'those

.lG misadministrations, than other diagnostic r 17 misadministrations. 1 18 Because of the way we've' broken it out, the 19 lodine misadministrations are being. double counted j 20 here. So, they would appear either as diagnostic or j 21 therapy as we)) as being in the iodine 131 column. 22 We're also particularly interested in iodine i 23

because, as we'll discuss -later, some of the new I

24 technologies involve the use of iodine and so we'may S T, be seeing more problems there if we don't get a good .r t. NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 J

a - G' 4 { 5 N L j< 3 I etip on it 2 ISlide) The next slide. 3 Just briefly, these are the five points in 4 the medical use program and we will be discussing each 1 5 one of'these five points. 6 (Slide) If I could have the next slide. 7 The first area we're discussing is program P development. There has been a fair amount of activity i 9 in this

area, rulemaking, contracts to gather 10 information, characterize what's going on in the 11 judustty

'a 1iti1e bit better e.id some other 12 initiatives that we've begun. I thank certainly one 13 of the major areas that has been involving the time of c..- 14 the medical staff has been the QA rule and the 15'. re gu l a't o ry guide. 1 G' Certainly in the near future,- a major 17' octivity for the staff is-going to be the 18-implementation of the pilot.- program. Over the period -l i 19 of from about Alri1 to August, we're hoping to see 20 whether licensees can implement the program - as i 21 published in the proposed rule and the regulatory l 'n i 22 guide and the. staff will actually be making site 23' visits to about 18 different institutions who will he -l 24 implementing this rule, l 2.3 At the same time, for about eight months, R .a NEAL H. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 2

7 { 1 m 3 [- n. 1 ihe staff has-been asking questions-about quality i' 2 nrsurance programs as they currently exist at medical 3 licensees, that questionnaire. The data is being 4, J 4 gathered. Tt has not been analyzed yet.. That.*n 5 another initiative we have in order to understand the 6 OA program. 7 One area that we're particularly interested 8 in and at least beginning to look at is human factors 9-since human error .is a major contributor to 10 misadministrations. Very rarely is it caused by 11 equipment or other kinds of failure, but usually by 12 human failure. 13 We're starting to'look into human factors, t ., - ~ 14 We don't know yet what the payoff will be, but we are 15 letting initial contracts in the-areas of human 16' ' factors as applied to teletherapy, remote 17 brachytherapy and computer planning of treatments. 18 So, we'll be doing initial studies in those three 19 nreas. We'll see what we get and whether to proceed 20 further and faster in those particular areas. 21 (Slide) Now, the next slide, please. 22 The second area that we were interested in 23 emphasizing in our five point program was inter-24-organizational cooperation. There are quite a few 25 r,deral agencie" and professional, scien t i fi c and ,'..) NEAL R. GROSS 1323 Hhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

p-4 s t.. p lq 10 ~ l ofher kinds of piofest,ional organizations that we have 2 been interacting with. There are no particular issuet. .3 to_ raise in this area. We feel that we have gotten F 4 excellent cooperation from those institutions thet 5 we've been dealing with and we feel that the G interactions have been quite useful to us. 7 (Slide) The next slide, please. 8 CHATHMAN CARR: I think you're running one 9 slide behind on t he screen. 10 DOCTOR GLENN: Could I see the slide-that's 11 there now" 12-MH, McELH0Y: No, it's the next slide. ~ 13 DOCTOR GLENN: The next slide. j 14 MR. McELROY: 'And the next. -l 15 DOCTOR GLENN: The next slide. There. IO-Okay. Thank you. 17- -The next area was staff development and as 18 an immediate result of the beginning the program in .19 FY'88, the regions were authorized to each go out and i 20 hire an additional inspector to add-to the staff 21 provided that person did have medical experience. We 22 have continued as those people leave and we replace 'h 23

staff, to make sure that we're hiring people who do 24 have experience in the medical area who will be able 25 to understand the issues and help us improve our i

i 4 NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

F.: - ~ a ~ i 5 ,.n. 11 p ,# ^ l regulat ion of t he medical program. ? 2 During '89, we added ileople who had 3: backgrounds in dosimetry, therapy dosimetry, nuclear 4' medicine technology and health physics consulting at 5 medical institutions. So we're continuing to make 6 sure that the people we hire to work.in the medical 7 program do have that kind of background. 8 CHAIRMAN CARR: 110w big a group is out_there 9 to hise from? 10 DOCTOR Gll'NN: It depends upon the specialty 11 we're looking at. Certainly with nuclear medicine 12 Iechnology, it's a rather large group and it's limited. 13 mainly by the educational background of the people who ~ ,w 14 are in that area. We would-also, of course,-like to 15 get medical' physicis t s and people like that. We're e 1G limited there quite a bit by what we can offer in 17 terms of salary. Dosimetry, it's a matter of_-- it's 18 a much smaller group to recruit from and we have to 19 look a little bit harder to find those kind of people. 20 COMMISSIONER ROGERS: What are the 21 professional credentials or academic credentials, say, 22 of the people that you've been able'to hire recently? 23. DOCTOR GLENN: This year? 24 COMMISSIONER ROGERS: Roughly. 25 DOCTOR GLENN: I think for the three that I L. NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 i (202) 234-4433

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~ ' mentioned, I think it,'s one bachelors degree and.two- , :.K 2- . masters degrees.

Now, we do have. ph.D.s in.the 3

medical program as well. So, we hire from a mixture 4 Lof experiences and academic backgrounds. 5 One thing, of course, that we try to do is t G to keep our own people's skills up. One thing that 7 AEOD was able to do for us this year was to modify the 8 telotherapy and nuclear medicine courses that are 9 offered' through the technical training center. . 10 They're not actually offered at Chattanooga, but are 11 cont rae t ed tbrough the technical ' training center. 12 We've had good reports on those courses. 13 For headquarters people, we have arranged

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14 for them to spend some time at local hospitals and 15 iefresh their memory and their skills in terms of 1G what's going on in the hospitals. 17 In

addition, we've had rotations between 18 headquarters and the regions in letting-our people get 19-experience on the front line and certainly here. in 20 headquarters.

We've had people come in and act ' 21 and -- 22 MR. BERNERO: I might add, Doctor Glenn is a 23 veteran of the front lines. We brought him up here 24 last year. 25 DOCTOR GLENN: Okay. Another thing we've a NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

m ,4 w 13 ~ I ilone recently-is to turn over the membership a little 2 bit in the ACMUI. Those 1etters have Just gone out, 3 and just mention that we do use the ACMUI in soluewha t 4-analogous fashion to the ACRS, as a technical group of 5 experts who can advise us on the issues that come G before us. 7 In a -separate Commission

paper, we're 8

setiding up to you a list of alternatives for a 9 visiting fellowe program. 'The idea would be to bring i I I l' 0 outside expertise into the Commission to make it 11 a v a.i l a b l e. to the staff as a part of this visiting 12 fellows program. 13 (Slidei Tf we could have the next slide, 14 please. 15 Having been out in the field and.on the 16 firing line, I think certainly an important aspect of j 17 our medical program is the oversight function that we 18-exercise both in terms of here in headquarters, i 10 tracking trends, looking at -- reviewing enforcement 20.

cases, looking at the licensing statistics and the i

21 misadministration reports. But a big emphasis since 22 '88 has been to increase our presence at medical 22 institutions. As a result, in 1989, the inspection 24 frequencies for the larger types of medical 25 institutions were increased. I think you can notice i 3

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NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

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0 - g' 14 a ~,- - L * ';; ll h e_ i o lii. I erms. of t be s t a t is t i cs Ihat there was'a'large j? w Ui jump.1n~theonumber of medical.i n s p e c t i o n s that were b

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performed between '88 and '89. V / '4 So, we have seen the effects of that change-5- in our priorities and I think particularly'I'm pleased -G t lia t these-increased ' inspections have occurred in-the p o -7? area of _ teletherapy and our larger -research and -8 imedical licensees, the broad scope programs, where g 'O they .d o.. m e d i c a l research,. as well as ordinary 10 diagnustie and therapy procedures. l11 COMMTSS10 NTH ROGERS: On t hose-l'nspect i ons, -12 from '88 t o- '89 you-nearly doubled t he - number' of^ 13 1nspections.~ - ll ow did you.- do that? How could you.do' p 14-t hat 'so quickly in terms-of manpower availabil'ity? 15 DOCTOR.GLENN: Okay. Well, we:did bring .lG on we at art edL recrui t ing, I guess, in.the summer -17 o f ' 88. So, by ~ he t.ime.we got'into FY'89,.we already-t i r 18-had 'n.'fnir number'of these people on board. So, we i 19' were able .t o, by the end of '89, really see those 120 extra people being out there and -- y I . 2 1 -- COMMISSIONER ROGERS:. Ilow many additional' 22 ' people did you add? '23 DOCTOR GLENN: Basically five people. l c i . 4 L24 -COMMISSIONER ROGERS: Five? To what -- how i 25 largo a base of people were doing luspections? l [r} ..,i. p NEAL R. GROSS 1333 Rhode Island Avenue, N.W. Washington, D.C. 20005 ,t (202) 234-4433 -{ wc i

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~~ I DOCTOR GLENN: We'll be getting to that in a H 2 Inter slide. S o,- if we can delay that one just a 3 little bit. 4 MR. BERNER0: A dozen and a half or so. 5 DOCTOR GLENN: (Slide) Okay. The next ] G ' slide, please. 7 The fourth area of the five point plan was H to make sure-that we were communicating more often, 9 hnving mor e information exchange with licensees and 10 professional groups. During '89, we were very actjve, 11 T

think, compared to what we had been in the past.

1 r [ 12 There were 31 presentations to professional groups.. ( 13 Appiosimately 50 percent of .thos'e were given by [. 14 headquarters staff and 50 percent by regional staff. ~15 In addit. ion, the . regions presented 15 1 1G workshops. These workshops varied from large two day 'l i 17 groups to in one region they offered a series of half 18 day workshops, mainly for medical technologists, to I '10 train them essentially in what was in the regulations l 20 and what were the most common kinds of noncompliance l 21: thnt we were seeing. l t h 22 I think for some of the bigger workshops,: 23 particularly note that participation by some of the -24 Commissioners and by senior staff I think heightened 1 2 r, the interest and improved the attendance. So, we had r, u a NEAL R. GROSS } 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 .d (202) 234-4433 l l

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p g' 1C p ~ ' 1 a 3ery enod response for these workshops. 2 COMMISSIONER ROGERS: What were ihese 3-professional groups? How many different ones were 4 there, just to get a feeling about what J S-DOCTOR GLENN:

Well, they varied from the G

Society of Nuclear Medicine -- 7 (Slide) Maybe if we could have slide 7.3, 8 that will give us some of the listing of some of the 9 groups that we've been interacting with, such as the .10 American Associatio-of Physicists in Medicine, 11 00ps. 12 COMMISSIONER ROGERS: Interesting,.but wtong 13 - slido. 1 -1 DOCTOR G1,ENN: Okay. We'll skip 7.3. 15 The American College of Medical Physicists, 1G the Amerienn College of Radiology, Society of.Nucieni 17 Medicine, American College of Nuclear Physicians,.the 18

Americai, Suelety of Radiation. Oncologists and the-

.10 College of American Pathologists. There were other 20 smaller groups I think that we also made presentations l .{ 21 to. -22 COMMISSIONER ROGERS: I'm just interested te { l 23 see how these things worked. Were these regionally 21 presented or they were all in this area? I mean how l 4 -20 did -- l Wj d { i i NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 i (202) 234-4433 l

q.. c .s 'o j s k h 17-e. 'l d - 1 DOCTOR GLENN: Oh, they were pretty much ~. 2-nerom. the count ry. Certainly the workshops. were } 3, regionally based and the presentations tended to be i 4. wherever 't he.societ ies or groups were having their I t 5 national meetings and so forth. i 'G COMMISSIONER ROGERS: 1 see. Okay. Good. 7 DOCTOR GLENN: They're actually quite I t 8 interested in having us make presentations at their i 9 nattonal meetings. So, we usuelly don't.have to try i 10 tno hard io get on the schedule. 11 In addition to meetings and workshops, we -4 12 continued to communicate t hrough our NMSS newslet t er, 13" k eepi n g l i ne e n s e e s informed of significant, enforcement - f 14 setlons, rule changes that were t aking place and ot her I 15. special topics.as they came uli through the year. 10 Anot her ihing to note is that professional g t '17 groups an'd association newsletters quite often use our 18: press rel'enses of significant enforcement actions', put 19 those in their own journals so that the word gets 20 spread a little more quickly and a little more widely 21 than perhaps through our own organ. So, 'there is t 22 interest out there in terms of what we're doing und '23' the word is getting out. a M (Slide) The next slide. The next slide, 24 Pii please. t ,u1 NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 5 (202) 234-4433 3

h,.) - 4 .c. c -o. I L in t.. ' 'j - t 1 As 1 ment t oned before, there at e some areas p 2 of concern or opportunity or problems, whatever, that (. 3 are coming' up in the area.of nuclear medicine. One L j.. 4 thing is that it's a growing technology and apparently L] 5 with a shrinking work force. We're told -that i t ' s. C hard to recruit people to work in this field, that the 7 . turnover is high. And so with more demands and fewer a people _to do it, it's obviously an area that we have 9 to Is..p our eyes on and see if there's anything that-i' 10 we have to do in order to maintain the. qualit y that b 11 already exists as well as improving it. h 12-We're also told that the current efforts to 13 maintain costs as low as reasonably achievable work ? [ 14 against improvements in-t erms_ of quality of programs l 15 y. medical. Institutions.- This is another area where !~ 10 we're t rying t o learn more, keep our eyes open and see 0 17 if there tw an-interaction that we have to be aware-of i 18 in terms of our regulatory program. V p 19 And finally,-there are new developments in 20-medical t "hm, logy. One that's-been just~ around the p 21 corner for several years now, and I guess. has not i-- ~when f -22 . fully realized its potential and.we're not sure 23 it

will, is the use of things called monoclonal l

24 antibodies where you use the antigen antibody reaction V 25 t o - aim magic bullets, so to speak, at tumors within F: h.! -NFAI, R. GROSS i. 1323 Rhode Island Avenue, N.W. ~ -Washington, D.C. 20005 d (202) 234-4433 rs-

7 3-1 o --, i L 19 j-y L-s. t 1 1 he-body. -~ 2 So far, the success has been more in the 3 diagnostic area. You are able to label these 4 autibodies and get them to the cencei sites, t ut to 5_ get -the kind-of ratio you" want in order to-be G effective in therapy and have it_be effective i 7 before -- sometimes there's some reactions. to the 8 mouse serum. -It's a mouse antigen that's being used. 9 They have not been fully successful in that area. 10

However, it's one of those things that if the 11 terhunlogy is perfected, we could see a large increase

[ 1" in the use of -iodine

131, in curie quantities in I

13 hospitals and it would have'a major impact. 14 So, we do have studies going on and I'll-1 15 just mention that one_of_the people we_didn't bring on 1G Inst year but:who.we hope'to bring on this year, we've '17 mad' en offen.-is a person who has been doing research-18 in.the-monoclonal antibody area. 19 (Slide) Another new technology is. high-20 dose-rate brachytherapy. If we could have the first 21 of the 35 millimeter slides. 22 What you see on the.left of the-screen is a the device that transfers the 23 - device that is-24 sources from n-shielded position into the treatment 25 aren. This part icular device has 18 tubes associated - T~~l 1 _J NPAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington,-D.C. 20005 (202) 234-4433-a

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n .~ E41 20: i. _,-; > p [T'* I with it and you can run a source into any one of those 18 tuben and it can be stepped through 48 different g. 3' positions within those tubes. Now, the sources that L' 4 are being used here are much. larger than the sources y 5 t he.t a re usually have in the. past been used for p i G brechytherapy for implanting into tumots. Rather-than i I 7 being t en t o 20 millicuries, we're talking about up to [ 8 to ten curie iridium 192 source. That.means t h'a t -- y o u 8 f 0 can cut the amount of time thet the patient has to be 9 10-irradiated significantly.- 11 So, in this part icular 't reatment, each one y 12 of those tubes, the source can be run automatienlly n [E' 13 and remotely in and out of the tube, stepped through a 14 programmed set of posit ions' and t reat the whole area E } 15 on the leg that is the site for the treatment. 10 This means that. brachytherapy can now be 17- -done on an outpatient basis. So it expands the [ 18 potentini number. of ,patlents who will .u s e ).9 brachytherapy as 'a treatment mode, whereas hospitals 20 -that are doing it only implants using the small' s-p 21 . sources, are doing maybe one or two of these a week.

22 I've been along on inspections where I was told that 23 they were doing 300 to 400 patients with this' kind of '

24 technology because it can now be used on an outpatient t '25 basis av en adiunct in teletherapy. So, it's R fy NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington,-D.C. 20005 (202) 234-4433 tr - [K,_

c i{ 21 [ '* *' 1 iechnology thet hak a. lot of promise. 2 There are some problems. Obviously, you're 3' .using computers, you have a source that ~has to move L 4 very precisely to within one millimeter. It has to l 5 move a lot of-times and so we're watching this very i I 6 carefully. We have had a couple.of misadministrations. L- [- 7 eaused by computer _ programming _ not. being. done quite U 8 right and so forth. So, it's a' promising technology h -9. but one that needs some attention paid to it. g 10-COMMISSIONER -ROGERS: In this particular t.s p; 'l l one, is it just otm source that's moved between these 12- -or are-there multiple sources? E 13' MR. MYERS One source, t L 11 DOCTOR GLENN: One source and it can be '15 moved into= each one of the 18. tubes and then i '1G poditioned by the' computer. l '17 MR. MYERS: If I may, the analogy to this i s-- .18 - like~a field radiography unit except this'is more like 1 ~ 10 a Gatiling _ gun approach where there's multiple lumens 20 or barrels.- The source extends out into. o n e,, 21 irradiates, ret ract s and it c o c k's o v e r to the next ^ 22 channel and then goes out. So, there's several. It .23 can run anywhere from a single time to up to 18 times 24 and there's a .t ot al of 864 positions between.the - 18 '25 channels that it can actually reside in. It's very a[ s. NEAL R.' GROSS 1323 Rhode Islarid Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 &-i -

P _ 6 ); [ i 00

! ;F

~N 1 anphistirated. T h.- big savings here is one of-ou t lial i e n t eni c. Obviously, you don't have to 3-hospitalize the patient Jn some cases. O '4 MR. BERNERO: But you see the complexity of-v p, '5' it, the increased intensity of the-source.- In order e i e h; G t o' get the power to be able to use this on an [ 7 outpatient basio, there's a price to pay and'that's 8 the complexity.and intensity. 'O DOCTOR GLENN: Okay. The next technology I F 10 want to discuss is -- this is sort of the upgrade of 'll brachytherapy into the next century. The next device 12 nor1 of ta'kes teletherapy io its next.logien) step. 13 (Slide) If we could have the second 35-H 14 millimet er slide. 15 This kind of therapy is called 'stereotact ic' L [ 1G therapy. The portIcular device that you're looking at li there is called ihe gamma knife. The gammn knife is F 18 used exclusively to treat brain tumors andJ1esions and 19-you can see that on-the patient on the table there 20 .that-there 18.this helmet-like thing around the-head. 121 The helmet is a very important part of the. treatment. 22 Based on x-rays and CAT scans and so forth, the helmet- - 23 --is very carefully positioned-on the person's head,and l-u 24 ~then the table that the patient is lying on moves back 2 ". i n1 o t_ h a t large spherical object in the back and then= r n 34 NEAL R. GROSS -1323 Rhode Island Avenue, N.W. Wash i ngt on, D.C. 20005 (202) 234-4433-ade

o 23 [. - j,. <")- ,1 the helmet and the device inate in such a'way that-the ~ .~ 2-person's. head is at exactly the right position for the 3 treatment to take place. 4 Now, this is different from teletherapy -in' -5 that a-teletherapy source you have one large source v G and you vary the-angles and the distances and the sir.e 7 of the fields that you use to treat-the person. This [ 8 device h n t, 201 sources. The next slide will' help.us-L- ~ advantage of that. One of the problems, of l-D see the ~L 10 c'ourne, that you have with 201 sources i s. that a 11 source eschanges, cetting ihe radioactive material 12 into-the device b e c oin e e, much more complicat ed.. So, 10 quite o f t eu they have to build a temporary hot ce)) et L,* ._s la the facility in order to get the sources - Int o the 15 . device. 10 -(Slide) If we could have the -third 35 17 millimeter slide. 18 This is a schematic trying to show what ~19 happeuk.with the gamum. k n i fe. Imagine t he. rays of 20 light or the radiat ion coming t hrough the - helmet and: 21-from the device, each individual source columnated so !s . 22 you have a pencil-thin' beam. 'And w' hat you notice is 23 that. they all come together and cross at one; point. 24 there towards the bottom. Now, what this means. is 25 thai' the outside of t lie head there's very little un u. n. s NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington ~D.C. 20005 F (202) 234-4433

[ [, ; =n ', _, g-e 4] I ] radiation being received by healthy tissue. Iut when i 2' you get t o-the point where a)) those lines cross, you i 3 have 201 radiation beams added together and you get an l I 4 extremely high radiation field over a very small 5 volume. The volume can be controlled to an accuracy a F G' of about plus or minus a millimeter and with a size of j; L 7' the order of millimeters or, at most, centimeters. a [ 8 it's called the gamma knife because it can 9 be u ed in = lieu of brain surgery. In effect, brain 10 surger) in extremely dangerous, especially certain j 11 eites within the brain where it's very hard to get to C 12 'it. You can deliver a massive enough dose to the 13 tumor to eradicate it, just wipe it -out t o t a l l y,'

2.

14' wiihout doing much damage to surrounding tissue. So, 15 it has the precision _of a scalpel without a lot of the 4 10 risks of the scalpel. So, it's a technology again 17 that has a lot of promise. You pay for it in the lit complexity of loading it up and also it's a rather 19 complex device to use in terms of the preparation of 20-Ihe patlent because getting that spot correctly 2) irradiated is tricky. .22 So, again, complexity and paying a price in >= 23 terms of the number of sources that h' ave to be_ jumped 24 i t, ihe price-you pay-for this new technology. 25 COMMISSIONER CURT 1SS: Just out of -T~~] L ~J. NEAL R. GROSS 1323 Rhode Island Avenue -N.W. Washington, D.C. 20005 (202) 234-4433

m l. m,. c .s s 25 .if C-

1. ~

[ 1 cutiosits, what sort ~ of regulut on y review and approval i-2 d o e +. o new device like this go under* E 3 DOCTOR GLENN: Okay. i 4 COMMISSIONER CURTISS: 1 take it we're not ,j b 5' involved in that, but.I'm assuming -- L b 6 DOCTOR GLENN: Well,-we have a role. We do I 7 e safety-review of the device. But'FDA is the one in. l 8 terms'of its medical approval, is-in charge of that. ll l-- 9 Now,- I guess one thing 1'11 mention is h [ 10 t h81 hot h of the devices that I've discussed here are ]1 comiog from outside ihe country. These technologles-i 12; are-coming from Europe currently. So, by the time 3 13 they get over here, they've been tried out and'they hgMb W-9 # 11. .have some experience with them. But FDA has the lead 15 role in terms of -- I 10 CilAIRMAN-CARR: Do we license-the 201 17' soutces? 1 R' DOCTOR GLENN: Yes, but I guess we don't 10 list them individually on.the license or -- r s 20 , MR ' BERNERO:. We or a state, of course. 23 DOCTOR GLENN: Yes. Okay. There are-f j g.._ f 22 -currently six of these gamma knife devices installed 23 in the United States and I; guess the first one was 24 about five years ago. people are beginning to:see how 25 successful they can work, so we expect to see more. z j.

.. a 4

NEAL R. CROSS 1323 Rhode Island Avenue, N.W. ? Washington, D.C. 20006 -(202) 234-4433

.? I i

• 8 e.

(_ : L .0 4 1 ('OMM I S S I ONER ROGERS: 'Are those sources i 2 individually monitored in some way for a period of f 3 time unless they were all produced exactly at the same J 1 4 time or something or the same very carefully t i 5 control the amounts of radioactivity? How are they n G monitored, say, ten' years after use? Would there be p 7 any dri f t in how what the strength of the p F A individual' sources is or not? i 9 DOCTOR GLENN: Actually, that.is a problem -l 10 ~in terms of how you calibrate this unit. With a one-f_ 11 source teletherapy unit, it's relatively simple. Here, 12 ' o r coni se. you can put a chamber' at - the point where F 13 you expect it to be and see that you're getting the. ~ 14 richt i ot al - dose. White iests, again, are a problem {_ 15 too. So, there is some complexity here.- Exactly now 1G t hey = nionii or each individual source, I'm not sure. -.17 You wouldn't expect, of course, much ' change t o' take L L: 18 place,- but you do need to. worry about the alignment, i 19 So, I think that's something that they would': check: 20 more frequently. I O COMMISSIONER CURTISS: To 'get back to,the 22 regulatory review question for a minute, could you 23 expand upon what the: relationship is of our review to L' 24 FDA's, what precisely we look at and how that relates-g. 25 t o 'i hei t FDA looks at"

1. ,h-mE '

) JL 1 NEAL R. GROSS b 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 _(202) 234-4433

f t ( 2? 1, e 1 DOCTOR Gl.ENN: Okay. We look a' the device 2 in terms of.the shielding that's available with the u. '3 levels at a certain distance from~the outside of the p 4 device to be safe for the people who are working in [ 5-the room. Is the device. engineered in such a way that-i. exposed' or 'it's not ))kely that the source could be G p 7 the source come out? Are the tolerances correct for 8 ihe fitiing together of the sources and the receptecle L 9' within the device? So, our people look at those kinds M' 10 of. things, basienlly radiation safety associated with'- 11' use of a device. U . 12 PDA is going to look at is the use of'this b'- 13 ' device apliroprio t e from a medical point of. view? Does 11 ibis device is 'i t safe to use with humans? Does it s 15 , benefit humans? Is-it effective? So,'they're.looking g 10. at medical safety and ' efficacy rather than ' rndiat ion V [ 17 safety and device safety the way we are. 18 -COMMISSIONER CURTISS: Okay. .10 DOCTOR G1,ENN: I guess we worry aboutt the-- c L 20 .in terms of ' transportation, the device may be; a ~ k 21 t ransport ation~ cont ainer itself. We would be-the..ones m. '22' who would be responsible for reviewing thet. b 23 (Slide) Oka). The next slide, and this'is. it I 24 - the final _. slide, shows the resources that have been i ~ being proposed for the medica) b 2 5.. allocated or. t ha t are [ .u.J s NEAl, R. GROSS 1323 Rhode Island Avenue, N.W. K Washington, D.C. 20005 F (202)-234-4433 t

o s .3I- _g 5 g 2R t. i 1. -prigram in the next couple of years. i 2-We had a large

increase, as I

ment ioned 3 before, in 1988, increase of five over '89. An'd '90, I 4 we're staying pretty.much level.- We do anticipate n 5 need for m o r e :. resources in the medical

program,

.t G particularly in the inspection and event-evaluation l 7 at en in t he regi ons.- That growth is'in some measuie B due to the implementation of the QA Rule. O

Also, we have $2 million programmed into 10 FY'91.

Most of that $2 million would be used to v t [ 11 perform on-si t e reviews of medical quality assurance l'2 programs as the rule becomes effective. l t .13 MR. BERNERO:

And, of course, the TY'92

- ~' 14 tesources are simply projected resources ' you see on -0 - 1 5 -- that table. You can see. we are' realizing this-

5 In increased oversight end.we're expecting the QA rule to

._ g. '17 come in und he picked up there, j 18 DOCTOR G1.ENN: Now, there's some fluctuat i on 19 in ileensing and so forth. I wouldn't pay too much l 20 attention, but these are rounded off numbers-and"the-f 21 staff required for licensing fluctuates somewhat based a s 22 on the number of renewals that are expected to'become 23 due each year.- So, there's some fluctuation just F 24 there. It's not a major programmatic choice that'says 25 8-9-8 there. l n.i i k 1, s (- NEAl, R. GROSS ~ 1323 Rhode Island Avenue, N.W. [ -Washington, D.C. 20005 (202) 234 4433 s 4

y'

N 4.

f i y.. .i O f] .I-t 1 COMMISSIONER ROCERS: Jus t coming back to my } i 2 earlier quest ion, about how big the base was in which 3 you added five, to get some feeling about how big the i 4 inspection capability -- how large an increase there 1 5 was. in that, you doubled the number of inspections j G essentin11y in one year. You're adding about roughly-i 7 a third more people. What else' happened to allow you j 8 to do_that many more inspections? Did you have to cut DJ back ou something else that you were doing to do that? 10 DOCTOR GLENN: To the best of my knowledge,. i 11 we didn't. I have to-admit, I was a little surprised i 1? nt how. big the jump was myself. I think it may have 1 "i been because we were putting particular attention.and 14 focus-on this that peop3e made sure that the medical i 15-inspections got done and that 10 MR. BERNERO: There's a hidden loss that we ' 17-got out ' of the way in here. Hugh Thompson right1y 18 points out in '88 we had the' static eliminat or - 19 exercise that took a great' deal of the resources -- f 'i 20 COMMISSIONER ROGERS: I see. 21 MR. BERNERO: ---away from-other programs. 22 ~We had very severe

impact, especially in the two t

23 regions,. I. and III,. Region I and Region III,. which 24 have. a large number of licensees. So, you aren't 25 paying'tha1 in this time period. You aren't paying t u._ NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

{:. -e '{ 0 Q t.33 ~~ J that hidden tax. I CONMI S S10NI'R C11RT3SS: I'm curious on the h 3 resources. Are we seeing a similar kind of trend in 4 the -agreement staten that have these programs and Lwould we expect the 'same kind of wrapping up' in y[ G. resources there for the QA rule? What's happening [ 7. there? . 11 MR. MILLER: I don't think so at the moment. f fl I think primarily here in the regions is a matter of 10' training, get the proper type of people to.do the job. f 11 That's where. they seem to have more of the problem. g 12 They haven't seemed to havo many problems yet on n-L-

• ~

13 hort ni a rf. 'It's a matter of getting t he. quel.i fi ed i 11 . people. That seems to be their_ problem. r' 15 Now, the gamma knife that you just - saw up. special topics 10 there, 'for an

example, we _had our 17 workshop back in December in Chicago.

It was an + lit agreement-st at e that demonstrated how - 'to do. the 10- . licensing-for that device. They took us downtown. s 20 They showed us-t he device.being used and there won ~ 2 11 very' good training-for the-l regions and for.the-other 22 agreement states. But'we' find though that we're just -y 23-going to have - t o do something to get- 'more people 24 trained for.the agreement states in these high tech 2:T o r c a r. that you just had discussed before you. p ,D -i NEAL R.- GROSS l 1323 Rhode Island Avenue, N.W. . Washingt on, D..C. 20005 (202).234-4433 u

p. g y 3) e i. '~ ~ F CII A I RM AN CARR: Well, I rend you as saying 3 1he Nr. eement States do a better job in inspecting e 3 their hospitals than we do probably. 4 'MR.-MILLER: Well -- 5 MR. TAYLOR: Did you say that? h.- G CllAIRMAN CARR: Is that not what you said? 7 MR. MILLER: No,.I did not say.that. p 8 CHAIRMAN CARR: Well, maybe you'd better say C D ti again, b 10 MR. MILLER: At some time ago,.we showed you e h 11 on a document, on a memo, that we were pretty much-f i f 12 abend ' of the NRC and the agreement atates as far as ~ 13 how ofien we do inspections. So, they've been doing .a ']4 more inspections on n lot of these program areas. But .35 now I would say ihey're pretty much par, you know. In ~ c 10 ofher

words, the NRC. has picked up doing more w

17-

' frequency inspections and some of the states were L 18 already doing'those kind -- f 19 COMMISSIONER CURTISS: So we're ca t chi n g.- up-20' - with'them?- Is that what you're saying? i 21 MR. MILLER: Yes, that's correct. [: 22 MR. BERNERO: Yes. But I think it would be 23 fair to say that as we see a pulse of activity associated i s 24 with the QA rule out in the field, that the agreement 25 states will see pret t y much t he same thing. p - rq - .g ; r NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

[h . x<Q ^< pg. 3, 3 E i ~' T 1 COMMISSIONER CURT)SS: Sure. L 2 COMMISSIONER ROGERS: Yes. 3 MR. BERNERO: And so, it's a forecast right '4. now o f. what we would expect to see. I think the r g 5 agreement states will.see it just as we do and I hope

~

[ 6 with equally good effect. p 7 Just one other thing on the resource. I'd [ 8 . j u s, i like t o' remind you, this program, the medical-i: 9 p hy r am tends t o. be a very asymmetric one' As you V, i, 10 knew, we were just dis. cussing t he agreement states are 11 very heavily into it with a lot more licensees than we i 12 hase. And our regionn) distribution varies according 13 ~1o the number 'of regional agreement states, to.the 11 ~ est ent, t hat' we have a lot of medical program activiiy 15 iu

t. oin e regions and very little in others.

And so-IG. i1's tery asymmetric. { 17 MR. TAYLOR: That concludes the [ -18 - present at ions, h 19 CHAIRMAN CARR: Questions, . Commissioner Li 20 Roberts? ,o 21 COMMISSIONER ROBERTS: No. -22 CHAIRMAN CA'RR: Commissioner Rogers? g' 23 COMMISSIONER ROGERS:

Yes, a couple.-

On. 24 . chart 4, if we could go'back to-that, I see that the 25 ii nn misadministrations account for most

well,

-i - :l l-s, ' ;a - NEAL R.-GROSS 1323 Rhode Island Avenue, N W. . Washington, D.C. 20005 (202) 234-4433

T' c c; g,o_ -3 r. g d 33

r 4 x.:

therap) 'l bertain]y more Ihan hol f-of the 2 in i s admin is t ra t i ons that you're counting .in both 3 diagnostic -and

therapy, apparently.

1s.there any 4 targethd program that one might address there for 1-G 131'use? G: DOCTOR GLENN: I think one thing. you _ might 7

notice, if

.you_ look at the QA rule as =it was" 8- ~ pub 1'ished,.is that it does treat therapy and. iodine on 9' an' equal-' foot ing, whether it's iodine for diagnostic 10-or iodine for tberapy. 11-Certainly, we're trying t o ' s e n s i t i z e _-- t h e 12 medi cal ~ coinmuni t y_ to t he -problems we've been seeing.

13.

with iodine,. and in these workshops that - was one of ' ' ~ " ~ he. items t hat was

stressed, that-we were" seeing 34 t

_1G' problems in this area. .] G COMMI S SIONI:H ROGERS: How many of - bese t

17..

mis admi n i s t ra t'i nn s do you think were truly IR' significant? t 10 DOCTOR CLENN: I would say I think most Eof-20 the lodine 131 and therapy are significant. I. guess, 21 - there-may'have been an example where _the iodine-was 22 given to someone who didn't have a thyroid or '23-something like' that, but that would only be-one or-24 two. And all the rest of them, when you're talking 2 r, thousands of rads to the thyroid, you're talking about 1 m i {.s - j'- lE NEAL R. GROSS .1323 Rhode Island Avenue, N.W. . Washington, D.C. -20005 y (202) 234-4433 ~

'm; y

C f'

a; V;

g 34

~ l 1 ot ent Ial 1oss of function ut l e a s. t, whether it is 2 in or e serious than thot. 5 3 COMMISSIONER ROGERS: What about the 4' diagnostic use, do you think you could make a comment 5 - on those? [< G DOCTOR GLENN: I would say probably'in none 'm 7-of them, except the ones that involve'd i o d i n e ', was 8 there any kind'of an immediat e-health effect such as 9 loss of function of an organ, death, or something of 10 1 hat

nature, that we're talking here really in the same r e a l u, as we're talking about for.occupat ional L

12-safety We're talking about increased risk of cancer

)

13 induction at.a later time. So we're out of the realm n -14 of direct harm into ihe area of risk. F 1 r. - MR. BERNERO: I t hi nk "i t 's wort h - not ing,- 1G generally in diagnostic procedures you're. talking 4 ~17 about exposures of_the order of a couple of hundred c 18 millirem, whereas when you_get into therapy -- or for 19 instance, there's one that comes to mind. Instead of e 20-was it 1,000 microcuries of 1-131, ' t he patient: got-l- b 21 .'1,000 millicuries. And it ablated the. thyroid.-,And 22 that's a pretty significant safety impact _on the ~ 23 _ petlent. L 24 Therapy patients are sick people. They're C 25-undergoine radiation therapy because they've got (lt f. F NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C; 20005 o L (202) 234-4433 s, ,.:h'..-

e 7 ;< 'e L> j 1 1 i 35 l a .j.., o - ~- 1 sever e tumois or something. Pi u t nes ert heless, it's i p: 2 l'ai r l y s i gni fi can t if you hit the wrong organ or miss-p 3 the mark either too high or too low in the dose that's f-4- prescribed. l 5-MR. TAYLOR: Some of the diagnostics are W: l 6 0 -relatively benign. i 7 MR. BERNERO:

Yes, they're fairly mild.

e 8 It's undesirable. It's unnecessary radiation exposure p P 0 to do h~ brain scan when really you're trying to do a 10 ~ kidney

s. c a n or something, but it's not the sort of i

-11 thing that you could put in a c l o s, s of heavy safety r J 12 . significance. 13 COMMISSIONER CURTISS: 3 was' ~ actually 14 int rigued by that same question, because I've seen the [ r 15 chart before and the statistics are kind of a funny IG thing. T h i> frequency here looks' f airly low, but if-17 you toke,.for example, the report s t hat we send out.to 18 Congress, if you measure significance by..whether it's p 19. an abnormal occurrence, it-looks like we've had about. 0 ' 20' a dozen of.those a year. And then if you take a look e 21 at -t he percentage of Aos - that' are medical in the 22 context of the whole, it looks like about a third.to l 23 over a half of the AOs that we report come from the ll 24 medical community. 25 So I guess I'd be interested when you.use

T'~7

L i. i NEAL R. GROSS 1323 Rhode-Island Avenue,_N.W. ~ Washington, D.C. 20005 L" (202) 234-4433

9 :. p, e-3G ^~ t his chas i tn have a comparison that elicits that 2 fact, the significant ones that we report to Congress. 3 If that's a measure of Commissioner Roger's question 4 of signi ficance. t here ought to be a column on here 5 ~t lia t says one-third to one-half of those for any~given G year act ually are medical misadminist rations. in the s 7 context of the way we -- o b 8~ MR. BERNERO: Abnormal occurrences. t 0 COMMISSIONER CURTISS: That's right. 10 MR. BERNERO: Again, a word of caution. The u 11 frequency is always a difficult number for us to get, 1P because the detioini nn t or of the equation.i s a very, " ~ ~ 13 vory crude estimate. We. don't I. ave accurate data on h' 14-hpw many procedures or patients, i: '15 CHAIRMAN CARR:

Well, when did we atart p-1G requiring all o'f-them to be reported to us?

Always?- p 17 MR. McElROY: AlI what reported to us?- 18 MR. MILLER: The agreement states. r 19 CHAIRMAN CARR: Misadministrations. I !- 20' MR. McELROY: 'In about'1981. l' 21 CHAIRMAN CARR: So as of now,-we'know all-22 the ones in the' agreement states as well as the ones .23 we-license? 24' MR..McELROY: No. ~ 25 CHATRMAN CARR: We don't. This number I -- l.. 1 NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 s(202) 234-4433 e / _

n ;;. y n o.; ( %/ r S 37 'i LY L h4'" 1 -uludes agreement statet.' [ i i c 2 . COMMISSIONER CURTISS: That 's correct sir.- { 3 CHAIRMAN CARR: Thst's the point I thought I e 4 we ought to make. -i ~ g, 5 MR. BERNERO: But even for -as, we. don't know 't n=._ [ O the denominator. ,And for-them, we don't, know-the i p p 7 -denominatnr. ~ R CHAIRMAN CARR: Well, but they license twice I L 9-H 6 lil a ll y - H S. w e dO. e 10. MR. BERNERO: Yes. That itself is a rough i i t .t 11 estimot". See,- the number of procedures per year in [* 12 wlii ch a p o t.i e n t

receives, radiation therapy-or r

.13 -r e d fa t i o n diagnosis, that -number is unknown. It's2 t ~'" 14 junt et,t imat ed; f rom a variet y of sources, about the t 15 i 'alproximate-level of such activity in the tini t ed s 3 10; States.- p l17 COMMISSIONER CliRTI S S : That's what I y 18l thought. 19 MR. BERNERO: -.It's pretty hard to -be 20 accurate on that. 21-CHAIRMAN ' C ARR: Give :or take 100,000 i n. 7. 22 million. b 123 MR. BERNERO: Give or.take maybe a couple.of. .i3 24-m i l l'i on. h 2A, DOCTOR G1.ENN: In fact, I think a few years j

i. a NEAl, R.

GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433~ j w.

7g, e ~ i .5 ' 4 - 38. .r3 . ~ 1 no we thought the right number was ten million. 2 MR. BERNERO: Yes. We used to use a numbei .i 3 eloser to ten million. 4 CHAIRMAN CARR:

Well, are the agreement l

G-states now telling us.when -- are we getting a tally i G on those?- ' 7-' MR. ~ MILLER: I was' just 'getting ready - t o - 8-address that, sir. The compatibility ~ regulation for-O the agreemeni states become effective 3 April. 1 10 CllAIRMAN CARR: Of this year? + 11 MR. MILLER: Dut this does not:mean, tbough, 5 32 thal b onne of the agreement states have not 'been. 13 -repoit1ng a)) ready. ~ 14' CHAIRMAN CARR:- No, I understand. But they 1A weren't required to? 16 MR. MILLER: They won't be required until.1 'f 37 - April.: That's when it becomes 'the compatibility [ 18 regulation of this year. LIO CHAIRMAN CARR: Excuse'me, Ken. 20. COMMISSIONER ROGERS: That's okay, no, fine. 21 They' re. all good questions. Interesting.to-hear th'e. 22 -answers. - 23 Still, I'd like to turn to chart - 6 for ' a 24L couple questions there. Could you say something.about ..25 1he pilot program? I didn't hear anything much about-- Q[ ~

1.

e NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 t-w

W-p y ['s. l a-c 34, p l 3I3 g 4 t -- 1 1 hat. Have you teceived any restionse to our iequest i p for vol u tit a r) part icipat ion yet ? 3 DOCTOR GLENN: Does Research want to answer L 4 t h a t i 5 DOCTOR BAHADUR: Mr.

Chairman, I'm Sher G

Bahadur. I'm the Branch Chief of Laboratory .7 Development Itranch, and it's under my branch that we i i L 8 are - developing the QLU. The pilot program' is ' also 9 under our responsibility. L 10 What we did was we have sent some letters to e 11 the NRC 1icensees and also-to the state program, 12 agreement state licensees. The first week of January, F* l3 ~ we sent about 72 letters. About 24 invitations were ~ 14 sent io -- let me just see to the NRC licensees, 15 and 48-to.the agreement state licensees. We got 12 i -1G responses, from the NRC licensees and 16 from the M 17 agreement-states. 1R What we did was at that time we moved to the 19' second round of invitations, and we again sent 24 b i ,20 invitations to the NRC, this. time different licensees, 21 and 48 to the agreement state licensees. To date, we 22 have got the positive response from P2 NRC licensees 23 and -- y e s, sir and 38 from the agreement state ~ 24 licensees. p i' ~25 CHAIRMAN CARR: That's totals? b. rg

a..)

NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 w ._,-,,a..

e q; s };,. ,_4' [ fe.g 40 ,a: g n 1 DOCTOR BAHADUR: That's total to da'e. Our l t -2 'gual has been to get 3 COMMISSIONER ROGERS: Oh, this is totals. I a. 4 s t. e. ^ b G DOCTOR-BAHADUR: -- 24 from NRC and'48 from- ..I' G the agreement' states. i 7 So what we have done is we have-moved to the b^ 8 third stage of invitations. As you s e e,: our success { g 9 rote has been more like one in three. So we have'sent h 10 30 additional letters to the agreement state 11 licensees,- hoping that about ten would be so by [ 12 March 9th, we are hoping to put a cap on this process, 1 13 and nt that time hoping that 24 'NRC licensees and 48 14 agreement state licensees would have volunteered, j 15 CHAIRMAN CARR:.Thank you.. I p_ 16 COMMISSIONER ROGERS: It ^1ooks pretty j 17 promising, though, so far, doesn't it?- r 18 ' DOCTOR BAHADUR: It is going onla very' great .10 success rate, and we have all the hopes that it will 20 be a good program. 21. COMMISSIONER ROGERS: Do you have any 22 feeling about the results of the contract study on l' ~ 23' training and experience criteria so far? 24 DOCTOR GLENN: It's really too we j u s t -' '25 hnd thnt a couple of weeks and -- by S, m b ^ NEAL R. GROSS 1323 Rhode IslandLAvenue, N.W. Washington, D.C. 20005 (202) 234-4433 y r

-{< ib je t r, --. y s 41 q.... "^' 1 COMMISSIONER ROGERS: I see. { 2 DOCTOR GLENN: -- we're just reading it, t r 3 so 4-COMMISSIONER ROGERS: Okay._ Too early on 5 that. G Have you got anything from the QA j i 7 questionnaires that looks at all to you as important .j R with respect to a decreased need for a QA rule? i 9 DOCTOR GLENN: We really haven't analyzed it i 10-3 et, i t- { 11-COMMISSIONER ROGERS: We've heard a great f 12, deal of ---many responses, tiegative responses, but is 13' there something-in there that gives us a significant' '4-** 14 basis for reviewing this need? i l 15~ DOCTOR GLENN: Okay. The actual analysis of: L IG: that is being folded-into another QA contract. L '17 1 don't know. Have we done any sort-of-18 informal -- F 1_9 MR..MYERS: . Sir, in just looking at these as i 20 they come in, in a very superficial-way, I don't see p> 21 anything there that's remarkabla one-way or the other. g i 22 The form'is very complex. Some of the narrative will 23 takeJa little while to interpret, and then to somehow 24' coll' ate the narratives into something meaningful.-- And '25 junt. li_ke 1 say, on a superficial basis, I don't see

i m ;

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GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 1 -(202) 234-4433 g

, t. -4 g*l l ,1 ,J 1

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1 anything remarkohl-in one positive or negative, f '2 whethei os not, you know, a QA is needed or not. t [ 3 11 appears that almost all of the responses- -1 do t e, m to indicate some type of QA awareness and, in [ S

fact, t.ome types of QA programs.

That 's -about the i E U 0 only thing I could'say. I haven't seen anyone that 1 '7 - know of who-comes back and says, "This fellow doesn't f 8 have-anything." They all seem to have something. But D what that all means, I think it's just far too early 10 t i,

5. n 3 11 DOCTOR G1.E N N :

Yes. And I guess I would 12 just mentinn ihnt's not really surprising.to.us that 13 -they nl1 have some kind of QA program, because the l ' ' ~

a.,.

t 14 Joint Commission on the Accreditation of Hospitals has 15 required for severn) years that they be developing OA ~ 1G programrs 17 MR. MYERS: And many of them appear to 18 participate in voluntary. programs that are beyond our

19

purview, but certainly necessary in terms-of their 20 overall medical quality programs and even in the 1

L 21 ' operation of their facilities. H 22 COMMISSIONER ROGERS: Well now, we've heard 23 n number of times that the medical community.seems to i 24 think that the misadministration rate is. as Icw as 25 pour.ible, riven human error. And does that say thnt i I NEAl. R. GROSS 1323 Rhode Island Avenue, N.W. , Washington, D.C. 20005 (202) 234-4433 7

f s L i 13 1 (he GA rule should be something which is part icularly t 2 desigued io make some improvements in ihat human error + 3' rate, and make some improvements alona 4 DOCTOR GLENN: Yes, I guess, as I remember. 5 when the Com.nission paper came up, basically, ~ we G-couldn't make t' h a t statement that i n-terms of the i 7 frequency that we might expect a large difference, t 8 However,- nenin, when-you look at the types of things e-9 that cause misadministrations, it certainly appears 10 that any kind of effective QA program would catch most f 11 of the ones that were reported to us. But they are~ I i 12 relntively

e. i mp l e errors.

Some of them I-guess maybe r ' ~ 13 would be harder to catch than-others, but it~ certainlyr l' .. a l -1 ' aplien rs that if t he QA rule that we have proposed were j 15 implemented,- that we could eliminate ~a good fraction' IG - 'of the ones that have occurred. Now how successful j 'l 17-we'11 be, that we don't know. 18 COMMISSIONER ROGERS: Chart 7-lists Lthe-r 19. Inter-organization cooperation. How effective-lins I t .20 been our interactions with FDA, in particular? '21 DOCTOR GLENN: We've had an extensive = amount ~- 3. 4 L ( [ 22 of discussion with them -- in-particular, having to do 23 with the petition for rulemaking -- to relax some of -24 the requirements that we have on the compounding or 25 ihe preparation of radiopharmaceuticals. And we've t i i i, > NEAl, R. GROSS t .1323 Rhode Island Avenue, N.W. ~WashLington, D.C. 20005 (202)~234-4433 s

a; ' :,7 .; r ' f., l i 4 l- ?. 7 -14 i n.. [

~ ~'

l. had overal meetings. We've had some good i ,I t;. T discussions. 1 won't say we have any answers yet, but + 3 the cooperation there has been excellent.- The fact I s i-E 4-is, they 'have volunteered a member of' t heir staff r 5 who's worked'on~some of their rules to help-us in the ~ G composing and writing of any rules.that we. develop as j [' p 7 a result =of this review. 8 .MR. BERNERO: 1 think it's worth saying we i p. { -9 have a pretty good relationship with FDA, although 10 that pnrticular issue, which will be discussed with i 11 the-Commission shortly, is a fairly complex ~ one and 12 sensitive one for FDA. And the Food and Drug [ 13 Administration is not a monolith, like many agencies. s .. ~ 3 14 ~They have different groups, different agenda. And as [ 15 a result, they don't sing with one voice just as other f 10. ngencies. 17 CHAIRMAN CARR: I thought all groups did. .] 18 MR. TAYLOR: Always hoping.' l i 19 MR. BERNERO: But in general -- i 20. COMMISSIONER ROGERS: Isn't that the beauty' ? 21 of a choir? 22 MR. BERNERO: Now in

general, our 23 relationship with FDA is a very good one, -a very

[ 24 healthy.

one, and we have interactions on the i

2t scientific level and administrative level frequently. 1 L A,. NEAL R. GROSS i 1323 Rhode Island Avenue, N.W. v Washington, D.C. 20005 t (202) 234-4433 L

5 3., ' y 45 h - ~ l CilATRMAN CARR: Let me piggyback on that. a 2' minute. Are ihe respective nuthoritles-clear and 3 distinct, ur-is there a lot of overlap in 'our area 4-versus theirs* 5 MR. BERNERO: I think they are clear and G distinct, but they do overlap, just as the line of 7 questioning a little while ago about a medical device 8 and a medical practice using a medical device. We 9 have hnd instances where the NRC, due to its more 10 intense scrutiny in the

field, will go into a

11' t i t u n t-i o n, an event in a hospital, as if it were an 12 NRC issue, and it is an FDA issue. And due to the 13 overInp of jurisdiction, we enn pass the baton to them 14 and do when we need to. 15 'T think people generally within the NRC and 1G within the FDA understand the distinction. There is l~ not n biur about who -- 18 CHAIRMAN CARR: We don't need some kind of 19 formal M011 or -- 20 MR. BERNERO: No, no. I think -- 21 CHAIRMAN CARR: -- agreement that separntes 22 the functions? 23 MR. BERNERO: I think our functions are 24 necessarily interrelated, but they are understood. 2E And at 1 cart in my experience in it, 1 haven't run r] LJ NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D'.C. 20005 (202) 234-4433 s

Oi?q'yh M ^ @kih n p g K;c

f, gp:s,

~, pg 40 of ", 11 'into o - situation where.somebody in FDA is !t rying to h '2. 'reguinte what we're supposed.to regulate or vire'

h I

iM 3 versa. It's just that it is'a complexz thing,'and in I would qunl i fy [ 4 'neither case

well, certainly p

j -5 t h a t -. I V G: In our-case, we are not _ trying to regulate t 7-the practice, of medici ne di rect ly,- anci PDA.is being l 8 very-careful about' regulat ing the safety and. ef ficacy i-fl. of drugs 'or devices o r-whatever,- and t hey' re - being. '10 very -careful about that. And so we both face t hat' s. g< 'll complication =of not getting too deeply into the 12 ,prontice of medicine. ^ ~' 13 MR. PARLER: Mr._ Chairman,- the C omm i s s i on ~, .. J G 14: -i f '1 mny,.the Commission in 1979 approved a statement

- 15 of_cenern] policy on the regulat ion - and the medical y

10-usen of radioisotopes. I had the occasion to-look at j 17 that._ b e f o r e I; came to.this meeting. That policy 18 s t a t eroen t exp1nins in some dutail and'quite_ clearly in' ~19. -t my judgement the respective authorities and roles of. 20~ the FDA and this Agency. -I didn' t ~ see. anything. In e -21 -that general policy statement that occurred to me to 22 . raise any red flags - in _ my mind about ' there being some_ m .23-ambiguous area that might, lead.to confusion. If there 24 is such an aren-which needs expanding, the way to_do - P f> it, in my judgement, would be to revise that general M. 1 -- L a NEAL R. GROSS + 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 s

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e n c., + - ' 1 policy statement, which, in. repeat, seems to me to be v ? comprehensive and clear. X <e. 3-' COMMISSIONER ROGERS: Good. '4 Are there any specific - visit ing fellowship L i 5 assignments-settied yet? 'G-DOCTOR GLENN: Not settled yet. p 4 7-COMMISSIONER ROGERS: Or have-you gotten to -8~ thot point yet? S D-DOCTOR. GLENN: There have been discussions, = 5 and 11 guess'in the paper that comes up.we're providing'. 10-3 11. some' alternatives, and perhaps we're recommendin g'.: t hn t. i 12' we actually~ take a little bit' -of.'two 'dtfrerent m 13: - pos s i b i-l i t i es, Because, there's one t hat we.t hirik we

+'

in a reliable consistent way and-always t

!S

-14 can implement 15. hnve a fellow. There's'another where weisort of t.hinh + .l G. - we have to wait'for the right person-to come along and j

1. 7 de. ready-and1willing:to bring that personein,_but we

18 -

can't guarantee we'll always - find that person when we l}

19 go looking.

-20' CHAIRMAN CARR: Commission's-already 21 . approved-the concept. [22 - DOCTOR GLENN: Yes. .23 CT! AIRMAN CARR: Why' don't you just go ahead E _2 4 ~ -and get it done? -I mean, what do you come back=to us PF for^ 'f L # ;J - NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 i

• 7

.(202) 234-4433

y, s.- 4H 3 U 1 MR. TAILOR: We have that -- P CHAIRMAN CARR: Did we tell you to? t 3-MR. BERNERO: The paper is up. 4 MR. THOMPSON: The paper was sent back. S-It's a question of when they're going to -- G MR. T AYI/OR : We sent the paper back so you 7 could add when you're going to implement. 8 Thank you. 9 MR. BERNERO: The ball is back. We have it, 10 nnd we can. We have -- in this sort of hybrid sort of 11 appr m b John spoke of, we have some strong sentiments 12 nnd_ feelings. 13 COMM1SSIONER HOGERS: Well, it would seem to a 14 me' it's-gotten a warm reception from the community, I 15 believe. And I_ would think if you've get the green 1G-1ight from the Commission, you know, try to move 17 quickly. 18 MR. TAYLOR: 'The thing that was missing was 1 9 _- when you were going to proceed, and we wanted you to 20 have that. If I don't have to bring that up, we'll go -2) ahead. 22 CHAIRMAN CARR: Just tell us you did 23' already. 24 COMMISSIONER ROGERS: Right, yes. 25 MR. BERNERO: We'll bring something with the i I .. j NEAL R. GROSS l ', 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433-

F [f :.; -L ,.o s k 49 ["~~ 1-p rm t tense. 2 COMMISSIONER ROGERS: Right. Good

news, 3

yes, 4

MR. B T'RNE RO : Bring the people. g S COMMISSIONER ROGERS: And thio, finally, on G the shrinking work force. Do you have any thoughts on 7 whether there's nnything happening to change that?' Is 8 .i t something that we're simply all. watching take 4 -9 place, -wringing our hands, while it

occurs, or is 10 somebody doing somet hing about it in some way?

It 11 seems as if it's a very serious need, and yet people 1" are not ent ering t he field. ' ~ 13 There's shortages all over, and the sources ~ .14 I of t rnined people are drying up, apparently, rather 15 than expanding to meet that need, curious.situat ion. 1G Usually when there's a need, people like to jump-in h 17 and try to fill that need. Here the need seems to be 18 . growing and the solution to meet that need shrinking 19' at the same time. 20 DOCTOR GLENN: It is troublesome, and I 21 guess some of the forces that are driving it are 22 certainly beyond our control. 23' COMMISSIONER ROGERS:-

Well, I'm not 24 suggesting that we necessarily can solve this, but--

2P DOCTOR G l.E NN : I guess the ihing that I'm rq i,.. - NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Wnshington, D.C. 20005 (202) 234-4433

e* m. [_k l. ~ 37 ya.- e, .t w. o; m1 e, yk '

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'g. s - ..t pp.Q-00

T~~t" ' :

N py " ~ l' , look i rig - t o see whether i t. has an effect is'that'the t i i 2' 6hort age has driven ~ salaries, up, at least in some 3 . areas,.and whether the economic incentive is enough to: is 4' bririg people back into the labor market in this nren. f: 0' CHAIRMAN CARR: Sounds'like a ripe area for -6 scholarships from somewhere.- ' ' -E 7 MR. MYERS: Sir, it may be that this'lis an 8. net j uri l ~i k e a pendulum. Typically, in medical fields, O we see-n preeminence or a beginning of a. field like 10' comput eri zed t omography, the CT systems, and when they-11 come out about ten years ago, peopie were getting out ~ 12-the black nrm bands for nuclear _ medicine because they '13 - were going to' have a funeral for. it. That never 14 . mater a lized, nlthough CT went off and' did its own i .15 '

thing, i

10 We'hnve magnetic resonance imaging" competing 17 'ogai ns t-us. ,There are a-lot ~ of things that are out l 18' there, such ns PET nnd -SPEC scanning, which wil1 be 19 kind of a slow start because it's very expensive. But

• e 20 what-will happen-is that eventually I think that some 21 of that will kind of draw back i'n.

But we will,'never 22 see,- in terms of the technologist, that great-number, 23. perhaps, thnt we had. It will probably always remain j 24 a little bit behind the power curve, because there are 2A= a. couple of things affecting it. One of

them, 1.p

. i. .,1 NEAL R. GROSS 1 1323 Rhode Island Avenue, N.W. Washington, D.C. 20000 (202) 234-4433 ~ w

p }y% +, ' + ,e e s 51 .w

3.

be,' ]_ ~ 1 obviously,; 's salaries,. and - as' t he' technologist and i 7, 2 ibe. physician become mot e dear, their salaries-will go' c S .3 up. That will-pull some'in, p f 4. The hazards that are associated with nuclent 5: medicine and t herapy are rather unique. We' re t he p[ i G-only ~ folks that really. get exposure :in the medical b ~ 7:

area, imcause - we wade; around in the radiation,- as 8_.

opposed to the x-ray and CT folks. -9 CilAIRMAN CARR: Figuratively

speaking, 10 r i g h t. '-

11. MR. MYFRS: RJght,.

sir, figurntively-12

. speaking, because basically-t he x-ray techs-can walk: s 13-behind the shield and we have' to be. there to: inject h 14 _ t he-isotope .t o .the. patient. It can't be done .'15. .remo t ely. We have to. position.the patients and.so -- 10 - f o' r t h. So-there is a perceived hazard. g '1 72 -And because you're also using - intravenous ' njections, 't here 's - al so_ a > perceived haz ard, perhaps,--- 18f i [ ']D. of contracting AIDS.and other types of diseas~e,'where 4 20 you -just ' don' t have to get into that, in ; many_. cases, V ~ 21' in other t _h i n g s.. So it's an issue.that is unresolved. y 22 Schools--have also-dried up in nuclear-23 technology, simply because a ;1ot - of the institutions-24 that funded technologist schools did it out ~ f -.t h e - o j 2s. m t ro money thnt they had in reimbursement-conts. j y 1 W NEAL R. GROSS j '1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 .[ (202) 234-4433

a o f i. f J 1-52 ~V# 1 They can no longer do that, and the schools dried uli, 2 COMMISSIONER ROGERS: I wonder whether t h i r. t 3

shortage, shrinking work force

'and shortage of 4 resources to meet Ihat need, is'getting into the right 5 quarters in the databases of t he '. people that are G looking at fields that need attention. You know, 7 these studies are done. Manpower studies are done 8 constantly. I wonder whether this gets lost in 9 something, whether it's so specialized that it doesn't 10 nhow up.in its own right. I don't know. I'm just 11 asking that question, whether there's any way in which [- 12 those manpower studies that have been done are looking 13 at this with some awareness of t he situation. 14 MR. MYERS: Yes, sir, I would sny they are. 15

NMTCB, one of the certifying boards, has 16 conducted a survey --

I think it was last year-- 17 addressing - t hat same issue, and that covered about-1R 10,000 technologists, approximately,.in their base. 10 I do know that we received some phone calls 20

from, I

guess, a

Presidential board looking into 21 manpower, that we address some of their concerns, and 22 directed them to the technologist societies for.that 23 issue. And I think it is_being addressed. You knew, 24 the outcome T'think is still -- you know, the game is E r ot ow- .. J NCAL H. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

("Q. ( i

g.

+ .i-C. .e 7n, de,g L -( t.. e h4 I p 33-e q ; -y n J' 1 -{ ~ COMMISSIONER: ROGERS:. Thank you. N-23 CHAIRMAN CARR: Commissioner Curt i ss ( S.:, n 3 COMMISSIONER.CURTISS: Just -a couple-of-p

_4

questions. The petition for rulemaking, can you i e l'l r p 5 us wha't the-siatus of that is, and maybe share with.us-- d o M G -some preliminary ' thoughts. on what? your current. v+ 7' -t hinking. is on some 'of - t he ' bi gger issues, and maybe-4 p' 8^ inik.nhout the one in particular that - -well, one of f. 9-thk ones that I've heard about.. That's~ the - package ~ question.-- Give.us a quick run-down on thnt.- 1.0 insert n k }}- ' DOCTOR' GLENN: I: believe Research has the-12 l eia d. 11 3 MR. BERNERO: Ohny, yes. Let R$scarch talkL 14 to it. ~ had 'the petition '15 DOCTOR BAHADUR: Well, we 1Gl submitted.to us in June o f L '. 8 9, and we-had published-g 1 71 the - n o t i c t-sometime in. September. We had lots of 11 8 ' comment. Actually, we received 466 comments. on' that' s -]9 petition. And needless to say, mos t - of ~t he letters = ,20 were for the petition. Actually,._ about 60 percent of. 21 the letter came as a form letter from the Society;of ~ .y .22 Nuclear Medicine. 23 And right n o w,- what we are doing is we have ? 24 b r o k'e n down that into various issues that.we are. q 2 ", annly/ing, and we are discussing the safety concerns a r 1:.. ~ NEAL R. GROSS 1323 Rhode Island Avenue, N.W. aO~ Washington, D.C. 20005 (202) 234-4433 e..

y_ _,. LL ~ b4 I m m. t 1 y wiih the

FDA, which John was mentioniog 2

enrlier. We had-had closed meetingn with threm nnd 3 tried to resolve some of the issues beforehand, before 4 we go in and go the proposed rule route. 5 What we have done so far is we have G published ihe. rule for

comments, and the public 7

comment will last until April of '90. And so far -- 8 COMMTSSIONER CURTISS: Go ahead. 9 DOCTOR BAHADUR: But actually, after meeting 10 with the

FDA, we have broken that down inta two 11 routes.

There's a-fast track and a slow track. And 30 we went through that for some time, and then we have 13 revised-the approach. 14 COMM1SSIONER CURTISS: And the two tracks 15 hinge upon the perceived immediacy of the issues - that 1G are being raised? Is that the distinction? 17 DOCTOR BAHADUR: More.than the simplicity of 1R the isnues, talking'with the FDA. And based on that, r 10 right now we're talking about the generic exemption on 20 certain issues. So there is a rulemaking activity 21 progressing normally, and then we are talking about-22 generic exemptions are some of the issues which we are 23 dealing with FDA. 24 COMMISSIONER.CURTISS: All right. 25 CHAIRMAN CARR: I noticed in the inst t .j NEAL R. GROSS 1333 Rhode Island Avenue, N.W. Washington, D.C. 20005 1202) 234-4433

51 -},-,: s 55 1 reculetory agenda report that the resolution date for 2 that thing has changed to undetermined, which doesn't 3 give me a warm feeling. Have you got any better data i 4 than that? 5 DOCTOR BAHADUR: The reason for rulemaking y G date being undetermined is because right now all -7 energies are focused.towards the generic exemption.- 8. CIIAIRMAN CARR: Okay. 9 DOCTOR B All A D UR : Which will take care of at 10 least five of the six items which were included in the 11

petition, so the iden is to put all the efforts, all 12 the concentration in this generic exemption, and then j

~' 13 go back to the rulemnking activity. 14 Cll AI RM AN CARR: So five of six i n-the i 15 generic exemption? I IG DOCTOR B All ADUR : Is what we are trying to l. 17 achieve at.this time. I 18 CIIAIRMAN CARR: And what's the date you're - 19 ~ shooting for on that? j ] 20 DOCTOR B AllADUR: Bob, would you like to -- 21 MR. BERNERO: Yes. The only remaining thing i l 22 is -- 'l 23 CilAIRMAN CARR: Want to hang your -- j 24-MR. BERNERO: Yes, well, let me tell you.. I 27. was n little oblique in talking nbout FDA. And on L p L. s q NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 w

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• $(

n,.- w. i,- 1 i - SG. t - 4 1 this particular issue, we're -- well,'to put it in a I .2 r.imple. comparison, when FDA has a recipe, a package 3 insert, they say that within that framework a drug is 4 safe and efficacious. When it is outside that, they 5 are no longer saying it is safe and efficacious, but G that is not necessarily unsafe. And our regulations 7 have tended to implement it as if it were unsafe-the 8-minute it's outside the recipe. 1 i 9 We had hoped on the generic exemption to 10 have unequivocal PDA endorsement of our action, and-l 11 they're being very cautious about it. We've had 12 repented meetings. And basically,.the intent is I i 13 hope to communicate with FDA this week at a high l ~ ~ ' j 11 management level to tell them, "Look, we really don't l 16-want to draw you out as an agency-and have you endorse i 10 everything we're doing here officially, but we're j 17 saiisfying ourselves that there isn't;a major obstacle 18 to going forward, and we're going to come forward with . 19 it that way." l 20 CHAIRMAN CARR: So we're looking for at + 21-least a no objection. 22 MR. BERNER0: Yes. It's a no objection, a 23 speak now or forever hold your peace sort of thing. 24 And it's just we had hoped -- l 25 C05!5fl S S IO NE R CURTISS: '" h e nature of the c.g i u ; NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 g a

Ib79 4 (Of(Cy w p.<

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L 67

a --

r %A p pp g,y g, y hnsc'consirued ihe FDA requi rement s Jon ' t.ht-a { -2 piii k n ee i n s,e r t n more si rict ly and-more conservatively 3-th~en they-would~ construe'them. p ' MR. BERNERO: That appears'tolbe the-essence i 5. of'the issue. .6 COMMISSIONER-CURTISS:- Now we are seekingsto 7 . a' d j u s t tbrough the exemption process our ^ -8 i n t c rps'e t n t i on to. permit the kind of'Intitude that PDA 9 envisions, and' seeking FDA's endorsement which._they're 10 reluctant to give us. 11 M R.s BERNERO: Pending' the long-range p 12_ .rbsoluti.on.of the issue through some rulemaking. This-s liko u discretionary enforcement,

our E*

13 is really e -i i_. i ~ 11 generic exemption

process, and

.that's why-your- $15 - n t-t'c u t i o n w a s needed. h 3Gt -CllAIRMAN CARR: Bu t ' t he -i n t en t. woul d L b e -.t'o t ..17- -drnft up.our exemption - statement and get: t hei' tno r ] 18 ' objection to it, at least?' i 19 I MR. BERNERO: That's the intent. 20 CHAIRMAN CARR: Okay. 21 COMMISSIONER CURTISS: And t hat-~ would come 22-back here to the commission? 23' MR. BERNERO: Yes,=we'll be coming-to you. 4l 24

Because, in ef fect, - we' re saying on a generic basis j

25 we're exempting n-whole class of activities. ~j .j h i NEAL R. GROSS J '1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 ] (202) 234-4433 .j a

,J gE..c, i g q,; - .y .o gq j'. r g.;m: GH '.. ' a - - > + -*' ~ f COMMTSSTONER CURTISS: And t hen t hn sixt h i 7 ^ t [1 insuv, J take it, would-be addressed'on~the slow tracio A 6 P 3- 'or ihe:rulemaking track? That-would'be the sub~ ject:of' w 4 ?l er.s ci mn ed i a t e concern? e W<

5 CHAIRMAN CARR:

I think I understood them'io f .G; nay-they dropped the fast track, slow track. 7 ' DOCTOR: BAHADUR: And I'd like t 'o say that 8 slow t rack may not be the right characterization of j r i f p .9 it'.. R i g h t '1 now - we have the exemption p o l.i c y on one 6 1 10 rout e, and. t he normal usual rulemaking on. the o t 'h e r 3 I. T [ 1.1 ; rou!e. s 12 MR. PARLER: Mr. Chairman, I'have'a comment. 13~ We ha.ve exemption provisions in 'the 14 regulations, which kind of:like' acts as a safety valve ? 16i 'whenever a-need for a safety vaIve comes up'from time-1G t-o time. But if'weIhave a regulation.onf'the books, b' 1 7 -. and - t hen somebody.wants to come out with. ageneiic- ~ 18 exemption.of unknown time dimensions'that'would c o v'e r 2 in-five out .of the six (points in a-petition-.for- ~ -20 rulemaking, at least in ' my -- mind the ' distinction 21 between the-generic exemption

approach, which w

22, presumably could be on a fast.' track, and a rulemaking, L m 23 approach which would be-on a slower track, becomes F .24-rather bl'urred to say the least. E 25 T. don't know whether 1 made myself clear'or &y 2. _. NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Wa e.h i n g t on, D.C. 20005 i (202) 234-4433 + 4

(* L F i; e f, 59 J - not. 2 CllAIRMAN CARR: Sounds like. you're saying 3 you might as well just cancel the rule, i-t- 4 COMMISSIONER CURTISS: Or to make an interim G change to the. rule effective =immediately. What you're G-saying is that-through the -generic exemptions you 7 effectively amend the rule. R MR. PARLER: You asked the question earlier 9 about

a. time deadline for changing the rule in the 30 regulatory agende.

If you can in effect short-circuit. Il or bypass existing rules by calling something a 10 generie exemption, it seems to me that from ihe legal l '1 standpoint' that would be troublesome. Certainly, it 14 would he troublesome to me. p 15 MR. THOMPSON: Mr. Chairman,'we did have -- IG CHAIRMAN CARR: Identify yourself. 17 MR. THOMPSON: Excuse me. Hugh Thompson,- 18 Deputy Director for Nuclear Materials Safety, Safety. 19 Nuclear Materials. Operations and Operational Support, 20 or something like that. I'm not.sure. 21 We had some clear debate on which approach 22 to -go with the staff,- amongst the staff members, 23 whether to go with an exemption as a fast track 24 rulemaking or just go with enforcement discretion. 25 And fhat discussion we had involved various members of

i. !

J NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 e

~. r-f 4' 1 GO 7 I tho

staff, and at that time we originally had 2

enforcement discretion. But based on -the concerne. n-. 3 that were expressed by, I guess, members ofithe' Office 4 - of General

Counsel, we did figure that it was n

5 cleaner approach, rather than having violat ions ihat G we were faced with not enforcing, rather than-having -7 exemptions. And that was the basis. 8 Mr. parler was not part of that meeting, but 9 in or der in describe the differences between the two, 10 it was to not have violations on the books which we 11 were not enforcing and going through a process of IP trying io grant multiple enforcement discretions when 13 those violations were' documented. And it was more of 14 a policy question on what the inspectors did when they 15 went out in the field and identified a particular 1G practice which was inconsistent with that current 17 regulatlon. lR MR. PARLER: I didn't mean to say anything 10 any different from what Mr.-Thompeon just described. 20 He's introduced another policy consideration. 21 Obviously, depending upon how many policy 22 considerations you have on the table, you can have, 23 ~relatively speaking, preferred options. 24-What I was suggesting-in>a broader context 25 is perhaps tho preferred option, or perhaps even ibe .. r~~1, wJ NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

p. p l r ~r c1 g-1 loeni requirement any.he to go through a rulemaking 2 'directly, rather than to change in effect the 3 substance of the rule by a generic exemption approach. 4 Cob!bilSSIONER CURTISS: If the problem is-n 5 generic one and if it's a problem with the rule itself. G-and i f, as General Counsel has indicated, there may be 7 some infirmities with the generic exemption approach 8 and distinct from the enforcement discretion approach, 9 Il u c h, that you've raised, isn't there - is there any 10 reason we couldn't address.that problem as quickly as 11 = ! -the ceneric exemption by simply going forward with an 12 interim final rule and address the problem with a ~~ 13 rule? ..a 1 'l blR. TH0b!pSO N : Certainly. That's exactly 15 the place I started off with. I mean, I wanted.to be IG there. I-tried to get there, and every door I knocked 17 on there seemed to be a reason not to get there. But 18 if we got the support, that is the best way to go, 19-without any question in my mind. But each time we 20 went through the

process, there was always some 21 objection with proceeding in that direction.

And th'e 22 direction that we're headed now-I thought had finnily-23 reached unanimous consent of the staff to do that. 24 But I certainly would agree that if we can 2A take the approach to go and hnve the basis.for 4J NEAL H. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

~ ,m. p. t e C2 7 c-i 1 supporting a rulemaking immediately effective, that 2' tbut's Ihe best-way io go. 3 MR. TAYl,OR: The staff will leave here and 4 inke a look nt that. We've been anxious to get thir G thing settled, so we'll take a'look and come back. O COMMISSIONER CURTISS: Let me get on to my-7 other two questions. I didn't mean to -- R CHAIRMAN CARR: Well it seems that if.we 9 know where we wont to go, we ought to be able to find 10 n way to get there. 11 MR. TAY1.OR: Hight. We want' to get there 12 soonest. 13 COMMISSIONER CURTISS: On the increased 14 inspections that you've conducted, I guess I'd be 15 i n t e rer. t ed in the flavor of what you've found and in 10 particular whether the kinds of things-that you're-17 ' finding square with the kinds of problems that the 18 proposed OA rule would address. Is there a match 19. there? 13 there an overlap? 20 DOCTOR.GLENN: I guess I have not seen a 21 different finding as a result of the increased -- / 22 inspection effort. I would say, though, that we're 23 going to those facilities where we see the. most. 24 serious problems occurring more often. And perhaps I 25 cuess what we hope is that in the future we'll see n l' i. NPAl. R. GROSS 13.* Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

Q k o, o y .G3 y ' " " ~ Il u t I drop-off because of - t but. increased attention. 2 this fi rs t go around, I don't.think'we can comment. 3 COMMISSIONER CURTISS: -Okay. Final question 4 .on the workshops. Can you give us a littie bit of a 5 flavor of what you're hearing, what you've heard from G folks in the workshops? What's.the temperature of -7 people generally out there in terms of the concerns 8 that they're raising ' and the questions that they're

asking, in addition to the material that we're o

10 impart ing io them? L (' 11 DOCTOR GLENN: Okay. There were sort of two. 12. types of response. One was the group-of people who

1. 3 oppreciated the fact that we were out there, that we 14 were talking to them.

We were explaining our 15 positions. They understood where we were coming from 'lr hetter and they appreciated it Just from that-point of 1, view. "liey, we know what you're talking about now, 18 and that's. good." 19 Certainly we also heard from those groups 20- ~ who felt that we were going too far too fast in 21 certain areas, in the area of QA in terms of enforcing 22 the package insert

rule, in terms of strong 23 enforcement on a compounding case.

We got a lot of 24 comments from a particular group who felt that we were 2; not in touch with what ihe Commissions position shoold r] u._)- NEAl, R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433

t) M T + m x; 4

c'

=-[ l-r '.. - _e.g g. t j;7 m ici p. m, a beiin terms ofz keeping out of.the practice of medicl~ne l~^ 71-h l'- 'und ihe practice of pharmacy. They fe] t=. t hat.we'd-1 /. $7 ~ 3-intruded too=far'into that; area. h

4 So - we.got two ~ separat e groups, one very 3

..35 positive. and - t he other one not necessarily negative p. G but_ telling us they-thought that_we were on the: wrong i i 7-. t rack i n: that particular area. E 4 8' COMMISSIONER CURTISS: All. right.

That's

~ O a l l,' I.h a v e. q 10' CHAIRMAN. CARR: I recently talked to Doctor a 1

Wolincky, the Administrator

'o f ' the Heal t hi ' Care = }-) 12-Fi nanci ng A'dmini s t rat i on, and 'my: concern was' whether ; '13 'they gin ve cons i de ra t i on - 'i f 'we throw in a rule for QA- ,m: t hai increases the cost to the hospitals, how do2they-4 It 15 -take that into account in figuring out their. . l _G finnneing. She said that she thought they had.QA - .17 p'rograms.in-pince,.but she'd take-a look at that. ' n t erac t ion ' do.you expect ~to 18 W h'n t kind of i 4 -19 have wi t h t he HCFA over the next-year? x 20! . DOCTOR GI.ENN: We've Just started making the. 21-c o ri t e c t s, really.. I guess,. one thing is that we've (22 got severnl-initiatives going on. One is -a contract e 23 t ha t 's_ goi rig t o help us understand a little bit better 24 what HCFA's role in this whole aren of qual'ity 2" anurnnre is, and we would expect, I

guess, t h o r, e i

g

L gj -

c, NEAL R.

GROSS 1323 Rhode Island Avenue, N.W. Washingt on, D.C. 20005 _(202) 234-4433

gn.; e = j r(j

c e

-c. sr'

h. :

C5 z 4 1 findings by late summer. But we do intend to, at a. t ~* { f' middle management

level, to institute ~ some contacts 3

and begin tocexplore with them some of these issues. .4 MR. BERNERO: Some of these other issues 5 appear t o be-germane to their scope of responsibility. G Just talking about the training and qualifications, if 7 we press for expenditure of resources and better 8 training and qualifications, as well as in general on a OA, are those costs recoverable? Do they know? Does -10 llc I' A know of t he shortage of trained personnel? There 11 are mnny things there and I think we need a more open IP and more active communication with -- 13 CllAIRHAN CARR: Well, along that line, when 14 you're looking nt t he. Advisory Committee on Medical 15 Uses, you might consider whether we need somebody from 10 H C I' A on that committee. 17 MR. TAYLOR: We're going to be meeting.on lH that 19 CilAIRMAN 'CARR: If it's going to ' cost 20 somebody money, they ought to know up front what we're 21 doing and why we're doing it. I don't know -- have 22 you decided yet.on whether we ought to expand that 23 committee to take in a state representation or not? 24 MR. BERNER0: We've talked about that. 2 P, Wo're looking thoro The Advisory Committee on t hi-r- L_ NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 p

[-V L y my..c, p : ' 4-3 7 ' 4: ' l 1^ .T Medical Us e o f 1 so t opes' i s much'more in the vein'of,an 2' -ACRS, looking ni .it from o diverse. t ech n'i ca l ~ -3 background, .a medical' use of isotopes. And so far E 4 we're less inclined to look for'a diverse viewpoint ~ or w 5 a diverse position.in the society, broad society not~ Ot something-like Society of Nuclear Medicine or'anything-a: 7 like that. m 8 So, therefore, public -interest groups or 9-sinie governmental groups. wouldn't ordinarily. find ~ i' -- 10 .their-way into-such a group. 'll. CHAIRMAN CARR: Yes. I'm concerned. What-

12 we do. has an impnet on both of those groups though.

it" 13. MR. BERNERO: Oh, yes, yes. .: a 14 Cl! AIRM AN - C ARR: ' ll o w = a n d when do 'we bring 15 ~them in best, I guess is the' question, t 1G~ MR. DERNERO: - Y e s.-- Should th'ey;be'a member. eq IT 'nf the'commitiee or should there be'an-orderly process IB to discusn wiih them the r broad issues.- as.well as: the i 10 adv. ice of the committee? We have in the past tended. F -20: t o -look at 'the advisory committee as experts in ;t he- .21 medical .use, practitioners, radiologists and medical r y 22 physicists, people like that. 23' ' COMMISSIONER' ROGERS:

Well, perhaps you 4

24 could get some kind of representation of expertise in 2G ther impact questions, financial impact questions 'l l _o .st .NEAL R. GROSS 1323'Rhode Island Avenue, N.W. j Washington, D.C. 20005 4 (202) 234-4433 i i

l ~ s.% ~. a. ~ r> a :- c g.e 'G 7 .h -- l i 4 i llinu t. 'a c t u o l l y being faced wJth. the dilemma. of- +u' 2_ ' simply n ' spokesman for the state g. MR. BERNERO: Yes. 3' -4' COMMISSIONER ROGERS: point of view. .+ -L 5 Presumably there. are some. organizations in-which 4 l V G' people.-develop an expertise at-analyzing funding L 7; impacts of certain kinds of practices of various" kinds' ~and regula'tions and know what the different: state 8 9-scenes are. We know this is very_much the case in'the: ' nuclear power i ndu s t'ry where~ there are lots. of 'll- .i ndus t ry experts' out there who can tell you what the 12 costs are-going to be o.f various regulatory

-aw-13 alternntives, and I wonder whether that might.not b'e a 14-way of_ getting that kind of dimension-into. the 15 commi t t ee 'wi t hout.necessarily s imply-provi di ng -- a--- s l ot

. c 10 on'the committee for an exertion of power, politics. 117 MR. TAYLOR: We owe-the Commission. response 'lD on that. In fact, I've set up a meeting 'w i t h.- t h e - x 19 siaff tomorrow just ~ to -explore these_ kind 'of + 20 questions. But the first position-of the staff was we - + ~ L21 ought io stick with the medical. We'rc going ~to be 22 talking about. that _and we'll be coming to the 4 y

23 Commission..

I believe we owe you a recommendation in. -24: that area. 25 COMMISSIONER ROGERS: Well, I'd just like to .I -t. NEAL R. GROSS -l 1323 Rhode Island Avenue, N.W. a Washington, D.C. 20005 (202) 234-4433 i 1 5 e

gv 3

- 7

3

=- (;r -.. =

1. lq '

3 s:e m-g' . p7 + ? yN~ Gn y;&,. 1 > - 9 :: j'Y 1 u : t.b h i T lhin'k what you riend on your commi t t ees - at:c f a ~ _2 ' e s p r i i 6l, not~ representatives. 3'- M R '. TAYLOR: There's a diffeience. q cV 4 COMMISSIONER - ROGERS: You could go -.outside 0 't^ lof. t he purely. scient i fic and: technical as long - "~it: [ 5 GJ <seems-to me, quiie valuably,. if. you keep 'that asLa 7. . guiding principle. 1 ?H' C'OMMISSIONER ROGERS: Understand. 4 9' CHAIRMAN CARR: Did we=do a-study.on tnerapy. j ~ '10 minndminist.rntions? Did somebody do a study.on that? ~11~ DOCTOR' GLENN: I think that on April 9th, l 12i 'AEOD will-probably. be discussing that in 'their -13 briefing. 14-CHAIRMAN CARR: -And on your;NMSS newsletter, L 15'. do you include the ACMUI members on the distribution > G a i .1G l i s t. and. the representatives of those professional 17 . ordani za t ions, are-they on :it :too?" If not, 'may ?I. IR

r. u gg e s t we put-them on it?,

l ' 19 - MR. BERNERO: -Let's check. 'I t h o'u gh t they. 20l were,_but -- -21 DOCTOR GLENN: Yes, I'll have to check. 22 MR. TAYLOR: We'll' verify that. 23 Will you do that? t CH AIRM AN -C ARR: The more people we can. send; -24 25 that out tc. T think the better off we']1 he because q; l L):_ NEAL R. GROSS 1323 Rhode Island-Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 i e ,,1

Qe ; _Q N I w. p', ' j o. g;\\ ,L [ y,, ~

3..

P-Gq, 4

31 p/dk%,

); . j,s, b '> .2 MR.,DERNERO: Yes. 1 think we've t~ried to E .1 n: 3 spread that out as much as possible^. j c -1 CHAIRMAN CARR:- It looks like a pretty. good r, I LS effort to me.' k g G:

Well, I

want to thank the staff ' for the b-E 7 ' informative briefing; and icommendi~them for their. .a fE 8' ~ e ffor t s ' over' the last year to further improve NRC's y -- u 9 regulation of medical uses of. byproduct and material 10 -to .s n s u r e-adequate protection of the public' from 3 11 unnecessary rndintion exposures. [ 12 Sinff efforts to communicate

with, the.

.13 licensees,-the professional organizations, states and -14s other federal agencies in the medical use area through

10 workshops, conferences and_

training' courses are V 'lG lparticularly commendable. 17

Also, I

commend the staff for pursuing. regulat' ions ? '18i innovative efforts to improve medical use 19' such as-the two step licensing program recently 20 implemented in Region I'. ~21 I : encourage the staff .t o - implement the.

22 visiting fellows program; to. seek opportunities. to'

.+ 23 conduct extended facility visits - and develop. ' firs t-24 hand understanding-of safety needs, which you've been t 2 ", 'dniiic: to solicit constructive comments from all~those -w, _q. L _1 L. NEAl, R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 i (202) 234-4433 1 m._ m L !l

r; w 5 h..

p' 3

1 1 ty p-

• 0'

p f$h

'l o u h i d <- or6ni za t-i ons. and'~ si a t es on how we - can. do 'a I y ',' 2 be t t er-job. You are going to provide your-paper on '3 'the membership ' of the Advisory ' Committee on Medical-po '4 lin e s.- I t hink, if you 'can af ford it, continue to ,, y n . 5 conduct Lthe workshops. I: think they're-valuable and- ~ o ...h

0:

' be sure that you get your needs into the five year' r t ., h 7- . plan so that we have enough resources to carry out the-4 8-program.. O I think the NRC, the a'g r e em e n t states' and a f L 10 the' licensees share the responsibility to take care ~of~ 4 Jp,

llJ the public and the medical uses and we must continue 12

.I n: pursue -this gou] by improving. the regulatory-p u 13 program within.the available resources. . - + Any additional comments? '14 ~ 15 - COMMISSIONER ROGERS:

Well, just to' 1G-reinforce what we - already, -I.: think, agreed 'on, t o get, 17 on very expedi t l uus l y.wi t h t hi's question: of. deciding

~18 whether a generic exemption or'an Interim ~ rule is'the-10 most appropri at e. way to go, -but to clear that: up 20 quickly.and get on with-it because it -is = a. very.- '21' sensitive. sore point out there with the community. 22 CHAIRMAN CARR: We. stand adjourned. t 23 (Whereupon, at 3:32 p.m., the above-entitled 24-matter was adjourned.) Y w i; % l NEAL R. GROSS 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005-(202) 234-4433

1

v..

L. CERTIFICATE OF TRANSCRIBER This is to certify that the attached events of a meeting of the United States Nuclear Regulatory Commission entitled: TITLE OF MEETING: ANN AL BRIEFING ON MEDICAL USE OF BYPRODUCT MATERIAL PLACE OF MEETING: ROCKVILLE MARYLAND DATE OF MEETING: FEBRUARY 20, 1990 t were transcribed'by me. I further certify that said transcription is accurate and complete, to the best of my ability, and that the transcriptisatrueandaccuraterecordofthe[oregoingevents. LL)W m Reporter's name: Peter Lynch l-l L L NEAL R. GROS $ COURT REPORTERS AND TRANSCRittR5 1323 RHODE ISLAND AVENUE, N.W. (202) 234 4433 WASHlNOTON. D.C. 20005 (202) 232 6600 a

,n,... _, %,e.

,\\*

9

i- ;

F I 1 i i t... BRIEFIt1G ON FEDICAL USE OF LYFRODUCT MATERIALS FEBRUARY 20,1990 JOHN E. GEtR ~ L. NOWAN L. MCELROY-CONTACT: JAMES H. MYERS c TELEPfi0fE 10: 192-437 q L J l-i i J l h, t 4 + . } I'

o 'Q'. s i TOPICS o THE PEDICAL USE lt@STRY o NRC'S PEDICAL USE PaoGRAM 0 AREAS OF CON &RN IN MEDICAL USE o PROGRAM RESOURCES l l. 2 t

'O i t i f i i Il0VSTRYCHARACTER12AT10N c Af&UAL CLINICAL PROCEDURES - 7 MILLION DIACRCSTIC - 150 THOUSAfD THERAPY O MEDICAL USE LICENSEES hRC AGREEFEliT STATES STATES HOSPITALS 2200 M00 PRIVATE PRAC. 400 600 Y O t I-3 1

_'O l a-( m i MISAIMINISTIIATi(A5 EFGTED IN IEC LIElGES LLT LYB6 M LYBB LYBT f1G DIAS c aIc 433 409 393 338 .0002 1-131 5 5 7 11 TitRAPY 7 9 12 10 .0002 L1RNSD.S Mb 348 3% 310 15% liMAvtD IEPORTED AS OF JANUARY l'JJO 4

r o. Lo l' t,'RC'S lO! CAL USE PfW#i 0 Ph0GlW)DEVELOPMElli ,) 0 IliTER-CRGAll!ZATION COOPERATICl1 0 STAFF DEVELOPbENT 0 OVERSIGHT O INF0WAT1014 5

} o t e ) i i I i 4 I PROGRAM DEVELORET GOAL: lifROVED QUALITY IN N. DICAL USE O DEVELOP GA RULE & REGULATORY GUIDE O DEVELOP TECHNICAL BASIS FOR DETEfE!!dthG METER CHAl(aES ARE NEEDED lli TRAINild CRITERIA O QA QUESTICl# MIRE O PROPOSED PRICE-ANDERSCN FCR RADIO-PHARMACEUTICAL LICENSEES TERM!!aTED 0 hutwfFACTORS 0 MDIOPIAfMCY PETIT!0f, 6

g* t IFFP-0DGAN17ATif*' (WPATifW GOAL? IISF FyltTI'r, Fonetw O fMS - FDA 1 -IICFA o EDA n IVIT o mf. k - @6 n nvA 0 PPnFre,tify1AL n Sr!Fti!Fic n ATNIHIRWAtlW O CPFTO4!Allm o AccpEptTATirw e 7

STAFF DEVELOPENT @AL: lisCREASED %.D! CAL USE EXPERIElla c FICEIRLY HIRED PERS0fd4EL llAVE l'IDICAL USE BACKGROUt2 c PRov! Dire REFRESHER TRAlf41NG - TTC c0URSES Cl1 INCLEAR MEDICitE, RADIATIOff THERAPY WERE REVISED - HELD CBSERVATIOf? DETAll FOR STAFF AT A f4EARBY HOSPITAL - liEADQUARTERS/ REGION ROTATION 0 RcTATIOld 0F MEMBERSHIP lli ACMUI o Vis! Tits FELLOWS PROGRAM UfE R LEVELOPME!!T 8 i il

.e i N DSir4(T GnAL: FAPLY PnTirF OF W Lnp]NG PPOBLEMS TPArk TPercq in 1.teP'STMG, I lSPECTION; O f AMD M19Afw!NicToAvint' Orpoore 0 IMSPFU f N'e - IV R7 F/9 - rY RP c;79 - (N 90,102n l l l l l l 9 l lli

l l. 4 b i. p f I i THFODMATim FFFAF# GOAL: WIPFSPDEAD hhticE nr NPC ArTIVITIES 0 3] PDCCEarrArtmit vn PporcSS!M'AL GonUpt 15 WnpKsHops rne 1,lepiggre n-s AstrCIATIN N WeLeTTrot list NDC D r"9 DFLEAccc o F P or.0 r3NIFirAtrr Fernacernr AcTims t ' i l l l t l s in t b

s I l I AfEAS OF CONCERN IN PEDICAL USE O SHRInvit.'G WORgFORCE 0 STRINGEfT REIMBURSEt1EffT C0fRROLS 0 MEDICAL TECHNOLOGY - MONOCL0tML AhTIBODIES - HIGH-DOSE-RATE BRACHWHEP#Y - STERE 0 TACTIC THEkAPY - CrMUTERIZAT!0tl l ? i ~ l l l l n )) 1

l l l l t ES0 LEES FOR NDICAL IJSE PROGRAM FY89 FY90 FY91 FY92 FlKIIGIAL AEAS FIE FlE FTE FTE PROGRAM DEVELOPENT & 2 8 1 7 2 7 1 7 EVENT EVAtuATim (W) INSPECTim Afe EVENT 19 19 22 23 EVALUATION (REGIWS) LIENSING (REGIONS) 7 8 9 8 SUPERVISIG4 (W & REGINS) 5 5 5 5 TOTALS 2 39 1 39 2 43 1 43 i 12 . =

i . a ? e p. O s - 3 , 'c. i ? ? RESERVE SLIDES FOR BRIEFING ON PEDICAL USE OF BYPRODlIT MTERIALS 1 FEBRUARY 20,1990 1 l l i 1 l l l

GA hLlB %KillG 0 PERFORPANCE-ORIEN1ED CA RULE - PILOT PRcGRAM TO TEST ltPLEFEfiTATION - Filat RULE TO COMMISSION MARCH 1991 - EXP/JED REPORT!hG PEQUIRENElvT 6.1

,- ?9 9 N:N' .-s l r l- ? I i RADIOPHARf%CY PETITION c ACNP/StF. FETITIONED FOR CHANGES IN hADICPHARPACY RULES C fl0TICE OF RECEIPT PUBLISHED .0 INITIAL STAFF EFFORTG DINECTED TOWARD PROVIDIt.'G !!<TERIN RELIEF 0 STAFF CONTliAJES TO WORK ON RESCLUTION p.-' i l l t 0 6.2 ? a

c 5 .e- _.s J 1 I i i k I f i e i i i + h h i 0 TELETHERAPY o BRACHYTHERAPY 1 0 TREATwittPLANNUiG ) f I l l .v 6,3 t g..

+ o h l l I t ? i RAD 10PHARf%CY PETIT!0ft i o PETIT!0ft RECEIVED FROM ACNP/SWI i 0 NOTICE OF RECEIPT PUBLISHED O INITIAL WORK DIRECTED TOWARD RELIEF FRCN CERTAlf! RESTRICTIONS O LONG TERM WORK DihECTED T0 WARD, RESOLUTION OF TFI REQUEST b 0 P 6,4 s.

'O. C' s != t / b e GRGANIZATIONS AFFECTING LICENSEES. O FEDERAL AGENCIES - 5 O SCIEffT!FIC OR PROFESSIONAL - 12 O CREDENTIALING CR ACCREDIT!!1G - PHYSICIAf4S - la F - TECHNOLOGISTS -5 - TRAlfilf4G PROGRAMS -3 L l \\ 7.1 F

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