ML20248L818
| ML20248L818 | |
| Person / Time | |
|---|---|
| Issue date: | 03/01/1998 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| References | |
| NACMUI, NUDOCS 9803240248 | |
| Download: ML20248L818 (296) | |
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1 1 1 UNITED STATES OF AMERICA I t p 2 NUCLEAR REGULATORY COMMISSION 3 OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS 4 5 *** 6 MARCH ACMUI MEETING i 7 *** l 8 l 9 White Flint North 10 Building 2 11 11555 Rockville Pike 12 Rockville, Maryland 13 Sunday, March 1, 1998 14 The above-entitled meeting commenced, pursuant to l () 15 notice, at 8:00 a.m. 1 16 17 PARTICIPANTS: 18 MS. JUDITH STITT, Chairman 19 MS. CATHY HANEY, Section Chief /Part 35 Project 20 Manager I 21 DR. CARL PAPERIELLO, Director, NMSS l 22 DR. NAOMI ALAZRAKI, M.D. 23 DR. MANUEL CERQUEIRA, M.D., Cardiology interests l 24 MS. DOLLY DURHAM, Naval Hospital 25 DR. DANIEL F. FLYNN, M.D., Radiation Oncologist i i l ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 ; (202) 842-0034 1 I _ _ _ . _ _ _ _ _ _ _ _ _ _ _ . _ . _ _ . . _ . _ . _ . _ __ _ _ _ d
2 E 1 PARTICIPANTS: [ Continued] 2 MR. JOHN GRAHAM, Hospital administration l 3 DR. ANDREW KANG, M.D., FDA 4 MS. RUTH McBURNEY, State. interest ! 5 DR. WIL B. NELP l 6 DR. DENNIS SWANSON, M.S., BCNP, Pharmacy 7 DR. LOUIS K. 1AGNER, Medical physicist i I 8 MS. THERESA WALKUP, Radiation Oncologist Tech 9 DR. JEFFREY F. WILLIAMSON, Ph.D., Medical 10 physicist 11 MR. BOB ZOON, NIH l I-l 12 13 14 15 i 16 17 ' 18 19 20 21 22 23 ' 24 25 l
- i ANN RILEY & ASSOCIATES, LTD.
j Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i. l j
3 1 PROCEEDINGS
- ) 2 (8
- 02 a.m) 3 CHAIRMAN STITT: Good morning. This is a treat.
I 4 Evidently, it's not. l 5 [ Laughter.] 6 MS. HANEY: Good morning, ladies and gents. We're 7 on the record. I'm pleased to welcome you to Rockville, 8 Maryland, to the NRC Headquarters for the public meeting on i 9 the Advisory Committee on the Medical Uses of Isotopes. My 10 name is Cathy Haney. I'm section chief of the Rule Making l 11 and Guidance Branch, and I've been designated as the Federal 12 official for this Advisory Committee. L '13 The meeting is an announced meeting of the 14 Advisory Committee. It is being held in accordance with the 15 rules and regulations of the Federal Advisory Committee Act 16 and the Nuclear Regulatory Commission. The meeting was 17 announced in the " Federal Register" on January 28th, 1998. 18 That notice stated that the meeting will begin at 8:00 a.m. 19 The function of the Advisory Committee is to 20 advise the NRC staff on issues and questions that arise on 21 the medical use of by- product material. The Committee 22 provides counsel to the staff, but does not determine or 23 direct the actual decisions of the staff or the Commission. 24 The NRC solicits the opinions of the Council and 25 the Council values the opinions of this committee very much. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
I 4 1 [Brief interruption from building PA system.] () 2 MS. HANEY: Okay. The staff requests that the ! 3 Committee, whenever possible, reach a consensus on the I' 4 various issues that will be discussed today or at any of~the I 5 ACMUI meetings, but also values stated minority or 6 dissenting opinions. I ask that if you could, please
'7 clearly articulate these dissenting opinions as we discuss 8 the specific agenda items.
9 As part of the preparation for this meeting I have 10 reviewed the agenda for members and employment interests. 11 Based upon the very general nature of the discussion that 12 we're going to have today, I have not identified any items 13 that would pose a conflict. Therefore, I see no need for 14 the individual member of the Committee to recuse themselves 15 from the discussion. However, if during the course of our 16 business you determine that you may have some conflict, 17 please state that for the record and recuse yourself from 18 that'particular aspect of the discussion.
.19 I would like to take this opportunity to introduce 20 the Committee members with us today: Dr. Alazraki will be 21 joining us later this morning, I hope; Dr. Cerqueira, 22 representing cardiology interests; Dolly Durham, is an 23 invited guest from FDA?
24 MS. DURHAM: From Naval Hospital. 1 25 MS. HANEY: Oh , from Naval Hospital - - I'm sorry i ANN RILEY & ASSOCIATES, LTD. } Court Reporters , 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l (202) 842-0034 l l _. . . )
l l 5 9 1 -- representing patient interests; Dr. Flynn, radiation j Y% )I 2 oncologist; John Graham, hospital administration; Andrew 3- i Kang, from FDA; Dr. Stitt, our Chair; to my left is Carl 4 Paperiello, who is the Office Director of the Office of 5- Nuclear. Material Safety and Safeguards - - he'll be with us ! 6 this morning until around 11:00; Ruth McBurney, who's { 7 representing the State interest. She's from Texas; 8 Dr. Nelp, hopefully he'll be able to join us later also; f 9 Dennis Swanson, representing radio pharmacy; Louis Wagner, ! 10 medical physicist; Theresa Walkup, radiation oncology tech 11 -- jobs does symmetry; Jeff Williamson, medical physicist;
' 12 and Bob Zoon is from NIH, again, an invited guest f 13 representing radiation safety officer interests.
l 14 As far as restrooms, they're out these doors to
. 15 .this back corner here. And when we-break for lunch I'll ,
16 give you some idea of some local restaurants that are within 1 j 17 walking distance. And the coffee's available across the 18 hallway. l 19 That should take us to - - 20 CHAIRMAN STITT: Carl, we'll let you make your 21 ' opening remarks. 22 DR. PAPERIELLO: Good morning. I'd like to 23 welcome everybody here. And I would like to thank you very 24 much. I think probably half the nation is still in bed on l 25 Sunday morning at this time, and we're up here and we're i i
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5 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l _ --- _ -- _ -_- _ _ _-- _ - _ - - - - - - - - - - - - - - - - - - - - _- __ -- . - - _ - n
i 6 1 working. And I do appreciate your assistance in this major ( 2 endeavor very much. 3 When I came here in 1993 I had a personal goal of 4 revising Part 35. I. thought it had to be brought up to l 5- date. I thought it had to reflect more realistically what 6 the risk was. And in some cases I think we had excessive. 7 Obviously, one of the major contentions in this ) 8 thing is training and experience. And when we revised the 9 Rule in the mid '80s we never did anything about it. We 10 merely carried; what was in the guidance from the '70s we 11 put it into the '80s. It certainly seems to be an issue 12 right now. 13 Just for those people who are here, and not just 14 the members of the committee, that would being that the l 15 Commission had commissioned the National Academy of Sciences l 16 to do a study. They made a report. The Commission, in 17 fact, did not fully accept the fact the - - it's easy to j 18 say the Commission did not accept that report. They went 19 and made a different decisions, 20' Obviously, some of the commissioners had changed. 21 The path we're going to down is based on Commission direct 22 _to the staff. And, basically, it is to make the Rule in the 23 terms of this Commission risk and form, perform and space; j 24 words which the Commission is still trying to come up with a 25
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and, actually, I understand recently has developed ANN RILEY & ASSOCIATES, LTD. Court Reporters . 1250 I Street, N.W., Suite 300 j Washington, D.C. 20005 j (202) 842-0034 >
I 7 1 words of direction to the staff to implement. () 2 3 Rule, or a draft Rule. We have a Rule. We - - or at least a proposed It's been on the Internet. We've 4 been collecting a lot of comments. I'm obviously getting 5 all kinds of correspondence with different views. Training j 6 and experience is one of them. There are some people in the I 7 medical community, and I point.to the Commissioner, there is 8 not a - - the Commissioners is not really a monolithic 9 medical-community. It's a bunch of committees with 10- different interests. 11 And I think a major task is going to be - - and 12 that was a problem that we didn't solve in the '80s - - is 13 for the '90s what should the training and experience 14 requirements be in the regulation. So that's an important i
) 15 issue that needs to be resolved.
16 Another issue is precursor. The Commission asked 17 for to address precursor. I guess my view on that is that 18 the term, " precursor" is clearly defined. And in the 19 conversations I've had in recent weeks with the staff is the 1 20 things that we need to know are things that we can do i 21 something about. And that is, precursors which are caused
- 22 by essentially - - one way of looking at it - -
l 23 vendor- supplied whatever. Hardware, firmware and software. 24 And I would like to note that there is already a 25 requirement to do this, if you can figure out what it means, O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
8 1 and that's Part 21. 10 C.F.R. Part 21 applies to all NRC () 2 licensees, not to reactors. IT's a very broad regulation, 3 extremely difficult to understand. But I have always taken 4- the position inside the Agency is when we define explicitly 5 in part the various parts of Part 30, the information we 6 want - - licensees, particularly material licensees, don't 7 have to figure out what Part 21 is about. 8 But Part 21 deals with anybody who supplies goods 9 or services to an NRC licensee that the failure of which 10 could have a serious radiological consequence. Now, if a 11 lawyer was here I'd probably get shot for the way I put it. 12 But it's basically what the regulation is about. And I've 13- said, well, for radiography we find what we.want to know 14 about defective equipment that radiographer use.
) 15 Therefore, radiographer don't have to figure out and define 16 for themselves what Part 21 means for them.
17 So I think when I look at precursors I would like 18 you to consider very much whether or not this Rule could be 19 crafted to address hardware failures. The way I look at 20 -- and, again, these are words I've given my staff - - is 21 hardware, firmware and software. In other words, you buy 22 from a vendor a system that's supposed to do something and 23 you find out that it doesn't work the way it's supposed to; 24 it has a failure that could lead to a serious problem. 25 That's the kind of thing I'd like to know about ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
9 l 1 because I can do something about it. And not only that, i () 1
- 2. much of the hardware you use, radiation sources that you use 3 it's hardware; whether it's brachytherapy devices or 4 ' teletherapy we license too. We're an agreement state 5 license. So we have another handle back on the manufacturer 6 because it's not performing in accordance to the way we l 7 licensed it.
8 And obviously, the issue on patient notification 9 is contentious. One of the things I've directed the staff 10 to do is prepare a very short Commission paper on that 11 issue. And actually, in the - - and if we can't resolve it I, 12 the report will eventually issue to somehow get a reading 13 out of the Commission before we present them with a final 14 Rule - - or, not a final Rule, but a proposed one.
) 15 But we are on schedule. And this Commission has l 16 shown itself to be very impatient when the staff does not 17 meet the dates on rule making. And, in fact, for your 18 information, as of I guess today in this Agency the lead for 19 rule making, which had been in the Office of Research, is 20 officially transferred to the Program offices. So, it's not 21 just this Rule, but all the rules that affect material 22 licensees, as of today, are now my responsibility and not 23 the responsibility of the Office of Research. And a major 24 factor in that was timeliness. So that is a constraint I !
[ 25 have on myself. [ l 1 () AJDJ RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
10 1 Again, I would like to thank you for being here. () 2 I know you've had to make an extra effort to do this. I 3 appreciate tit. I truly want a good Rule. I want a Rule 4 'that we can all live with. And I want a Rule in terms and ! 5 the words of this current Commission that are j 6 risk- informed, performance based. Thank you. 7 CHAIRMAN STITT: Any comments for Dr. Paperiello? 8 [No response.] 9 CHAIRMAN STITT: Any questions? i 10 [:No response.] l 11 CHAIRMAN STITT: One of the reasons that we were 12 able to get him to attend with us this morning, if you'll 13 look at the agenda you'll see that the issues that keep ( 14 stumping us particularly relate to medical policy statement (_hs) 15 and training experience. Cathy Haney and I felt that he 16 really needed to get in the middle of the foray to see - - 17 I hate to start off our morning with those two things, but 18 nonetheless, we'll do it again and he's here to watch. 19 If there's no other questions or comments right 20 now, Cathy it's look like you are the agenda. 21 MS. HANEY: I think I've covered most of the 22 administrative remarks already, so I'll just jump right to 23 past ACMUI recommendations. There was one item that was 24 left open from the April 1997 meeting. And that was a 25 request that we go back and look at the QM procedures, O g i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
11 1 inspection procedure. That was tabled last time just () 2 because of the on- going rule making. 3 And, again, I'm going to do.the same thing. We 4 will be looking at inspection procedures for the entire 5 medical use program; along.the same line of what we're doing 6 right now with the Rule. But right now the Rule in any of 7 the associated documentation is taking precedence over those 8 inspections procedures. So, I'll report back in another six 9 months on that particular time. , 1 10 If you go to your tab in your book - - if you i 11 want to just follow along - - because I'm going to zip 12 through~these past recommendations fairly quickly. You i 13 should have a tab of " Previous ACMUI Recommendations." i i 14 Relative to the 1979 Medical Policy statement you ig, O) 15 had that some requested that some changes be put into one of j 16 the alternatives. If you remember last meeting what we were i 17 working with were the Rule alternatives that were going to 18 be discussed at the facilitated public meetings. So for l l 19 each one of these - - what came to be called the 20 cross- cutting issues - - there were several ways of l 21 dealing with it. 22 So, again, we're a little bit beyond that right H23 now, but I want to at least give you an idea of what we did 24 with your recommendations. In the case of Medical Policy l
- 25. statement we did present the revised ACMUI recommendation at l
() ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 ( l Washington, D.C. 20005 (202) 842-0034
12 1 the facilitated public meetings. () 2 The requirements for a' Quality Management Program, 3 looking down through that the ACMUI preferred Alternative 2. 4 To a certain extent that is what has gone into the strawman I 5 Rule, and we will be spending some time speaking directly to 6- QM in a few minutes. I won't go into any great depth here. 7 But Number 2, "The Rule should not include an 8 audit program". We did not include an audit program in the 9 strawman. 10 "A requirement for written directive and records 11 of administration should remain", that was done. i 12 " Retention of written records does not need to be ! 13 addressed in Part 35." We did leave a requirement in there l l 14 'for written records. Again, we felt that it was necessary !
) 15 to be able to go back and look at these records.
16 "The licensee should not be required to submit QM ; 17 modifications to NRC." That was taken out of the strawman i l 18 Rule. l 1 l 19 With regards to Alternative 2 here, on the next ) 20 page, Number 6, we did not go back and change the 21 alternative as it was presented at the facilitated public 22 meetings. We did, however, in addressing I tell them what ! 23 the ACMUI had recommended. 24 The reason we weren't able to go in and actually i 25 change the recommendations at that point is there had ANN RILEY & ASSOCIATES, LTD. ! l C Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l i
l 13 1 already been a lot of cases already been mailed to some of () 2 the invited participants and had been placed in the public 3 document room. But at the meetings we did make them aware i 4 of the ACMUI's position. l l 5 In the case of the 50 REM limit we did go back to 6 the current structure. We realized that we could not take ! 7 it dose- based for requirements for a written directive. It j 8 was just going to make it a little bit more cumbersome that 9 we could do. l l 10 Number C, "The requirement (a) (2) should end after ! { 11 ' identity is verified'" we did put that into the strawman. l l 12 And the last particular item, clarification about I 13 identifying revising an existing directive, that's not done. 14 -And that's something I'd like to speak to you about when we i 15 do discuss QM just so you can get some additional ideas of
-16 what you would see us doing in that particular area.
17 Under radiation safety committee, the Committee 18 preferred Alternative 2. In the strawman we actually went 19 with what was referred to as Alternative 3. We wanted to 20 give the licensee more flexibility, and we'll discuss that 21 today. 22 Training and experience, the working group did 23 incorporate this philosophical approach to training and 24 experience into the Rule. 25 Radiation physicists training and experience, we ANN RILEY & ASSOCIATES, LTD. Court Reporters j 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l (202) 842-0034
14 1 did incorporate that into the strawman. () 2 In the case of reportable and recordable events, 3 the first item - - several of these items relate, again, to 4- the way the alternatives were at that point. We took it in 5 this case we did go dose- based. So the actually listing 6 for each particular modality changed a little bit. So I 7 think it would be better, again, just to wait until our 8 discus? ion to make sure that you agree with the approach 9 that we have taken. 10 Something controversial, we heard a lot from the 11 different groups. What we are doing right now is preparing 12 a Commission paper that, hopefully, Carl will have in his 13 hands on Tuesday at the latest. I hope. And now that I've 14 said that on the record he'll really hold me to it. 15 DR. PAPERIELLO: Well, we talk about the - - I 16 just thought we really need to get it to the Commission in 17 March so we can get a read- out, if we're going to have 18 their guidance in the Rule, that we've proposed on in May.
'19 That's a timing problem.
20 MS. HANEY: And there are two items in that 21 Commission paper. One is the patient notification. The 22 other is precursor events. So there will be some times 23 today where I'll be asking some rather pointed questions, 24 mostly so that I can get it into the Commission paper 25 because the draft that exists right now has got some blank () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 E---- - - - - - - _ _ _ - - _ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - _ - - - - - - - - - - - - . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
15 L 1 spaces for things that at the March meeting of the ACMUI the () 2 recommended. So I'll be trying to get.a lot of input in 3 those areas today so I can get it into the paper by Tuesday. 4 And I believe that's it with covering the past 5 recommendations. Any questions on those particular items? 6 (No response.] 7 MS. HANEY: Okay. Status - - I'll just keep 8 going? 9 CHAIRMAN STITT: Yeah. That's what we want. 10 MS. HANEY: Okay. Status of the Part 35 Project. 11 Since we last met, which was September in 1995, we 12 held two facilitated public workshops: one in Chicago and 13 one in Philadelphia. And we had a workshop at the 14 All- Agreement State meetings. That was the 15 October- November timeframe. 16 During that timeframe.we also met with several 17 professional organizations. It'was typically during the 18 aemi- annual or their annual meeting. They just asked 19 someone to come and be a guest speaker. I did some 20 presentations. Don Cool did some presentations. And then 21 we met individually with an organization if they requested 22 to meet separately with us. 23 Starting in around the December timeframe the 24 working group started to meet on a routine basis to discuss 25 the input that we got from the workshops and to start ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
16 1 developing the strawman Rule that was placed on the Internet l 2 on January 30th. 3 .During January we started working on that guidance 4 document, which is that two and a half inch thick document 5 that you've gotten. What went out for the ACMUI 6 subcommittee meetings was the first draft of that. WE made 7 some changes after the meetings with the subcommittee, so 8 what you got mailed this time was the second draft. We 9 recognine it's still not there, but again, because we're 10 marching on and when the meetings are, you know, we're 11 having to release things a little bit before they're l 12 perfected. 13 The week of February 2nd we had meetings with the 14 ACMUI subcommittee. Monday and Tuesday we met with the i 15 diagnostic group - - or, I should say a diagnostic focus. l 16 Thursday and Friday we met in Illinois to discuss 17 the therapeutic aspects. Those meetings were very helpful 18 to us. Unfortunately, again because of time, we weren't 19 able to incorporate all of the comments that you gave us. 20 But we'll be addressing those as we go through the different I l 21 sections here today, too, and maybe asking for a little bit 22 extra clarification on some of the items. l 23 April 9th the document is slated to go into Office l 24 Concurrence - - the Rule Making packagu. The Rule Making 25 package includes the Rule; the statements of consideration; I-() ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 ' Washington, D.C. 20005 (202) 842-0034
17 j 1 -a Commission paper - - now, this is different from the one l 2 that I had mentioned already; an OMB package; a regulatory 3' analysis; environmental. assessments; the guidance new reg ) 4 and Congressional letters. Also, tied in with that will be 5 any recommended revisions to the medical policy statements 6 and the statements of consideration for that. So, we have a l 7 lot to get done before April 9th. j 8 And<what happens internally here is that we put it 9 into Office Concurrence and all the other offices have a 10 chance to provide us comments. Now that we, hopefully, 11 resolve those comments - - incorporate them, or whatever 12 -- and then the document gets forwarded to the Commission. ! 13 It's due to be forwarded the end of May to the Commission. 14 The future after that is it will - - once it's 15 published in the " Federal Register" there'll'be a 75- day i 16 formal comment period. During that period we hope to hold 17 at least two, if not three, facilitate workshops. One will 18 be in Washington, probably here in the auditorium that will 19 - - one of the reasons for the D.C. visit is just that it i 20 will allow people that are here at Headquarters to be able 21 to come and sit in and hear the comment comments, rather 22 - than going to another place. 23 We have talked about having a West Coast meeting 24 and a mid- United States meeting. If there are any 25 particular cities that you think we should consider for l ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 ' Washington, D.C. 20005 (202) 842-0034
18 1 having the meetings, if at one of the breaks you want to let () '2 me know, or a member of the working group that's in the 3 audience know, we would be happy to consider that. Probably
- 4. by the end of next week we'll have to decide on where those 5 meetings will be held so that we can get conference room 6 space.
7 All-right. And the final day we're all working ! 8 toward is May of 1999 to have the document to the 9 Commission; the final Rule. Again, it's the same package 10 with all those items I rattled off before, but all 11 finalized. 12 Any questions on the status? 13 MR. SWANSON: I don't know if this is the time to 14 bring it up. But I know it doesn't appear on the agenda, 15 and it was a major topic of discussion at'our working group. 16 And it might be something you might want to discuss while 17 Carl's here. And that's basically the role of the guidance , I 18 document, vis- a- vis the regulations; in that when we ' 19 submit applications we're basically required to comply with l l 20 various statements in the guidance document. Hence, the 21 guidance document becomes, in fact, de facto regulation. { l 22 And I know we had considerable discussion in our ' 23 working group about the inappropriateness of that approach 24 and the problems that the regulating community has with that ! 25 approach; in that, your regulations can be very i ANN RILEY & ASSOCIATES, LTD. Court Reporters , i 1250 I Street, N.W., Suite 300 ' fashington, D.C. 20005 (202) 842-0034
19 1 performance- based, but the guidance document becomes very () 2 prescriptive. 3 We recommended at our working group that you take 1 4 a serious look at the guidance document, if there are things 5 in there you truly want in the regulations, to bring them 6 forward into the regulations and not have tie- down 7 conditions to the guidance document as part of the licensing 8 requirements. 9 MS. HANEY: I can tell you what the working group i 10 has done the last week, and then I'll turn it over to Carl 11 for some. comments. 12 The week after the meetings with the 13 subcommittees, Don Cool, myself, Diane Flack, met with Carl 14 and discussed the input that we got from the subcommittees,
) 15 and which to go. What we did this week - - because the 16 working group's been actually meeting since Wednesday - -
17 we have broken that tie right now such that there are still 18 model procedures. But if there is something in the 19 procedure that we feel is an absolute, that is something we 20 would be looking for. 21 We're going to back now and seeing if it needs to 22 be put in the Rule. In fact, that's what some of the 23 working group members will be doing later this afternoon. 24 And break - - and basically in breaking that tie. And the 25 thought is that at the time of license submittal we would be l I () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
20 1 seeing things like the training and experience facility [}
%J 2 diagram; the equipment that you have, but not asking for 3 procedures.
1 4 That's where the working group is right now. But 5 it is a different philosophical approach for NRC not to be 6 reviewing procedures at the time of licensing, and not to be 7 tying. 8 So, at this point I'll turn it over to Carl to 9 comment on more of the NRC management position on that. 10 DR. PAPERIELLO: Guidance documents should be just 11 that: guidance. They should not be requirements. And if 12 they are requirements than the job hasn't been done very 13 well. That's the philosophical position. 14 Now, you've got to deal with the practical aspect. l O (gl 15 If you're going to have performance- based requirements and 16 if the licensees have to tell you how they're going to meet 17 that performance as a condition to getting a license, we 18 need some kind of guidance at least to our own license 19 reviewers on those things to accept. 20 A practical matter, too, is is I regulate a lot of 21 different types of licensees. The reactor side is, frankly, 22 a very similar community. There are differences in reactor 23 designs, but you're dealing with utilities with very large 24 staffs. 25 I doubt if a typical gauge user really wants very I i f(A i N#
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21 1 much in the line of performance- based regulation; almost 2 like my car. ( ) We drive a car. There are regulations 3 involving automobiles that we never really think about. The 4 manufacturer builds the headlights with the right kind of 5 brightness in them and visibility. The taillights. The 6 ability to brake within a certain sort if space. 7 So, to a certain extent, I nave to provide 8 guidance which has prescriptive elements that a licensee can 9 adopt for those licensees who, frankly, don't have either 10 the money or the expertise to turn around and reinvent the 11 wheel themselves. 12 I mean, there's only so many different ways that 13 one can calibrate a survey instrument. So, if I turn 14 around, either by reference to an ANSI standard, or by n ( ,) 15 including a procedure, you know, in the licensing guide that 16 an applicant can adopt, I'm effectively doing them a favor. 17 Because the practical matter is I'd say, you have to provide 18 me an acceptable procedure for doing it. And I have a lot 19 of licensees who, frankly, can't do it, because what they're i 20 going to do is if they don't do it themselves they're going l 21 to hire a vendor to do it. There is a tension. 22 I have adopted a policy across the board in 23 everything I regulate here - - because we have not done 24 this in the past - - is that when the guidance documents we 25 put out, we're putting out for comments. In the past, l ANN RILEY & ASSOCIATES, LTD.
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22 1 standard review plans that we have furnished our license () 2 reviewers our licensees did not see. 3 I have now changed that. They're all in writing. 4 They're all being put out as new regs. They're all putting 5 out for comment. And we are seriously considering comment; 6 because one of the things I found when I took over this job 7 - - and I had done some regulatory impact surveys for the 8 Commission - - is we've put out documents for review and 9 comment. People reviewed and comment on them, and we did 10 nothing about it. And I am trying to at least demonstrate 11 that we Sre trying to be responsive. 12 But there is a tension cn that. There is a - - 13 and I recognize that tension. And we are going to put out 14 in the licensing guide for medical use for review and 15 comment. 16 If you think there are things in there where we 17 are being prescriptive that ought to go in the regulations, 18 then I think you need to bring it to our attention. Because 19 I think we need to make a decision whether (1), we'll even 20 put it in the reg; or (2), we just will write it in such a 21 way that it's clearly not a requirement. 22 But clearly, if you have a performance- based 23 regulation, the licensee and the applicant has to do 24 something to meet it. And if you say, okay, it's your 25 choice on how you're going to meet it, and it's sufficiently ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
I l 23 1 important, there's-going to have to be something presented 2
) to you on how it's going to be met.
3 But this is a - - I understand the situation. 4 But the guidance documents are just that: guidance. And if I 5 we ever put'out one that does not offer a licensee or an 6 applicant an alternative, then we have done our job right. 7 And you need to let us know about that. And I will'tell ! l 8 you, we'll respond to it. 9 MR. SWANSON: Yeah. I think some of the problems 10 lies is you do allow alternatives, but then the alternatives 11 are basically judged in accordance with the model procedures ; 12 that you include in the guidance document; and, in fact, 13 become policy. 14 Yes, I'm licensed to drive a car. But I don't () 15 have to submit with that license the procedures I'm going to 16 perform daily in driving that car. I'm licensed to practice 17 pharmacy. But I don't have to submit to the licensing agent i 18 the procedures that I'm going to perform in order to meet 19 the regulations governing the practice of pharmacy. 20 I think what ycu need to do, you know, if there 21 are certain sets of procedures, such as the ones that Cathy 22 mentioned where you need to have those in order to review a 23 license, then require those. But I don't think you have to p 24 require all procedures to be reviewed by th'e NRC. 25 DR. PAPERIELLO: I agree. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300
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24 1 MR. SWANSON: Okay. I\ 2 DR.~PAPERIELLO: I agree. I agree. Qf 3 CHAIRMAN STITT: Jeff Williamson? 4 DR. WILLIAMSON: Well, I just wanted to call Dr. 5 Paperiello's attention to one document that, I understand,' 6 is a guidance document which the community finds 7 particularly onerous: the licensing guidance on remote 8 after- loading brachytherapy systems. Which, for example 9 -- as you know - - there is no requirement whatsoever for 10 calibration of manual brachytherapy sources. But if those 11 same sources are placed in a remote after- loading device, 12 they have to be calibrated every month. And we're forced to 13 adopt that as a licensing condition in our institution. 14 Actually, we talked them into every 12 months.
) 15 But it's an example where I think a very 16 prescriptive guidance was really imposed.
17 DR. PAPERIELLO: And I know. And it was done as a 18 result of an accident. And it was done in haste. And 19 probably, the answer is somewhere in between. I mean, when 20 you think about why we got where we were on manual 21 brachytherapy, it's due to history. And due to history that 22 in the deep, deep old days 2 think manual brachytherapy was 23 prescribed in terms of milligram hours of radium. And 24 probably, the answer is what should be is somewhere between 25 the two extremes. ( ANN RILEY & ASSOCIATES, LTD.
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25 l' And that's why I need people like to make what is () 2 reasonable recommendation. You ought to know what you have. 3 But we also know once you know what you have, there's a lot 4 of applicable laws of physics that then step in to determine 5 where you're going to be And so, what would be something 6 reasonable? 7 DR. WILLIAMSON: Well, you know, I'm not debating 8 whether it's useful or appropriate to have a rule regarding 9 calibration of brachytherapy sources; I, in fact, agree with 10 you. I was just responding to your question: can you name 11 for me a piece of NRC guidance that's imposed on us as an 12 absolute rule. And I was trying to give you an example. 13 DR. PAPERIELLO: The answer is the Agency has a 14 history of putting out guidance documents that look so much () 15 like a requirement it would be very difficult to tell the 16 difference. I know that. 17 I'm trying at least in my organization to break l 18 that chain. But there is when you have a tradition where 19 things like that have been done, it's not easy. I need 20 help. 21 CHAIRMAN STITT: We're here to help you Carl. 22 John? 23 MR. GRAHAM: I think just to elaborate on the 24 subcommittee discussion, it was in light of the history of 25 the linkage between guidance and enforcement, in light of () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
26 1 ;the de facto regulatory stature that that guidance took. () 2 But the subcommittee, at least, recommended that, therefore, 3 you should minimize guidance. 4 I think where we may have philosophically have 5 disagreed was that if you have a performance- based rule, l 6 then guidance is required? No. You have a 7 performance- based rule you are placing the responsibility 8 on the applicant for a license to perform. And that license 9 application either has to have the internal expertise to do 10 that, or they have to have enough common sense to hire 11 outside expertise to help them do that. 12 And as such, don't give any guidance, I think was 13' a very simplified approach. We understand that there are 14 small institutions, small places that may not understand how C\
\ ,) s 15 to do this. They need to understand that they have that 16 limited expertise. They ought to hire somebody, if they 17 need it, to complete the application. I guess we're la concerned that if they have to have a cookbook to fill out i 19 the license application, there was some question about their f 20 ability to maintain radiation safety throughout.
21 So, again, philosophically it was a difference. 22 But if it's important enough to be regulated, than make it 23 part of the regulation. And if not, don't give guidance, 24 but let the applicant document the way they're going to 25 achieve that performance. O' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 r (202) 842-0034 L___-__-_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ _ _ . _
27 1 And particularly, I think the sensitivity I () 2 continue to hear is that it's the largest institutions 3 cutting edge medical providers of this type of care that 41 . spend time trying to explain why they're not following a 5 very detailed guide plan, because frankly, they're way out 6 on a continuum providing better, more sophisticated, greater 7 control care. 8 And the difficulty they face is that somehow 9 they're trying to fit that program that they designed with a 10 great deal of thought, into a written guideline that, by 11 definition, was nothing more than a model. And I agree, the 12 alternative is always stated in there. But the model 13 becomes a hurdle, a threshold that you have to overcome. 14 DR. PAPERIELLO: Well, I hear what you're saying.
) 15 But there are a lot of difficulties within the Agency to do 16 it universally. I'll get out of medicine. I'll get into 17 other areas, and I regulate. Part 70 deals with special 18 nuclear material. But part of the problem I have is I have 19 a relative handle of facilities; fuel facilities. We'd say 20 they're all the same. A reactor that's not.
21 I have eight major fuel facilities and only four 22- different things. I mean, I have four different things. I 23 :have at least four fuel facilities in this country which are 24 one- of- a- kind. And if, in fact, we didn't handle the 25 details of how they're going to be operated through O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
28 1 licensing, and the like, literally rule books would grow () 2 thicker and thicker. I mean, it's just a practical thing. 3 I'm going to be called upon likely to be licensed 4 a new type of enrichment facility, AVLIS, over the next 5 several years. Now, do I write a whole new rule on AVLIS? 6 Or, do I turn around and go work with the applicant to 7 develop guidance, and deal with the requirements for that 8 particular facility through the licensing process? There 9 will only be one of them in the United States. Just like 10 there's only one or two gaseous diffusion plants which I now 11 regulate, which we did develop a special rule for. 12 I'm just saying, I understand what you're saying. 13 But some of the part of the problems are, is in many cases, 14 Parts 30, 40 and 70 are very, very general rules. And if
) 15 you're - - what the alternative then is to make an 16 extremely thick rule book.
17 But I do hear what you're saying. And I 18 appreciate that. And it's always a tension. It's 19 fascinating historically to consider that it was a GAO 20 report in the '70s that sort of even put us in the situation 21- where we are today where, in fact, we do review procedures 22 the licensees are going to use in their licensing process. 23 Because apparently, at one time - - and this is 24 before my time - - we didn't. I mean, I'm only brought up 25 under what has been going on at least since the mid- '70s. l-( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 t
l l l 29 i 1 But, basically, it was a Government Accounting Office that f%
) 2 said, you have problems that you could've prevented had you i 3 reviewed applicants' procedures.
l
, 4 I mean, it's an interesting thing to see how we 5 got to where we are today. And I understand it. And I '
6 think as we move toward the performance- based approach, 7 these are things we need to understand what we're doing. j 8 And there's a great reluctance to let go of what we're doing 9 now, without knowing what's likely to happen. 10 CHAIRMAN STITT: Other comments while we're on 11 this topic? 12 Go ahead, Dan? 13 DR. FLYNN: Well, I think the reg guides can be 14 useful. But I think what's happening, Carl, is that 15 regional inspectors will sometimes fall back and use the reg 16 guides as being the regulation. So, you know, another way 17 around this would be that -- and I said this a few years i 18 ago - - that in the introduction to every single reg guide, 19 NRC should put a statement that this is a guidance document 20 only. It is not the regulation. The licensee does not have i 21 to comply with the descriptive nature of this reg guide. i 22 This reg guide is one means by which we feel that the 23 licensee can meet the spirit of the regulation. 24 And then, in terms of the reg guide, which I 25 believe can be really important is that this committee and l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
l 30 1 professional societies should be able to contribute to how
/G l 2-i] the reg guides are constructed. Because they become a 3 useful document; especially to small licensees who have some l 4 difficulties. And even can be sometimes useful to large l
5 licensees also. But it should be only one means by which 6 the licensee can meet the spirit of the regulation. 7 DR. PAPERIELLO: The fact of the matter is they 8 say that. That's exactly what they are. And people ignore 9 it. 10 DR. FLYNN: Well, old Reg Guide 10.8, I don't ' 11 believe it says that - at least the copy I have - - on the 12 introduction. The old 10.8. 13 CHAIRMAN STITT: Dr. ?1=tzraki, do you have a 14 comment? 15 DR. ALAZRAKI: Yes. I think what we're saying, 16 and what the professional community feels, is that under 17 performance- based rules, guidance documents should be 18 minimized for those being regulated. But should be 19 maximized for those who are doing the enforcing so that they l 20 understand through education and through instruction how 21 performance- based works, and what it means in terms of how 22 they do their enforcing. Because that's been so much of the 1 23 problem that we've faced is that the enforcing inspectors i 24 don't really comprehend just what we're talking about; the l 25 difference between guidance and rules, i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034 w___-__-___--_-____-____-__-_-_____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - - _ - _ _ _ _ _ _ ____ ---
i 31 1 CHAIRMAN STITT: Manuel? 2 Yes. (
)' DR. CERQUEIRA: I'd also like to make a l 3 comment that, you know, when you're talking about Part 70 as !
i 4 opposed to 35, we're - - performance- based is appropriate, 5 but then we're also talking about risk- informed or relative 6 risk. And certainly there was Part 35 in diagnostics; the 7 risks are relatively low. So, the whole role of the 8 guidance document should really be minimized. And that's 9 kind of key point in this. 10 And I certainly understand you're administrative 11 dilemma with having to cover both Part 70 and Part 35. But 12 the reality is that certainly in diagnostic, and most of 13 therapeutic, the risks are relatively low. And that needs 14 to be kept in mind. 15 CHAIRMAN STITT: Other comments, while we're on 16 this topic? Dan - - or, whoever you are? 17 MR. SWANSON: Yeah, Dennis. 18 CHAIRMAN STITT: Okay. 19 MR. SWANSON: And, in fact, what the abstract to 20 your current working guidance document says is, " Comments 21 received will be considered in developing the final guide 22 that represents the official NRC Staff position. Once the 23 final guide is published, NRC Staff will use it in its 24 review of requests for licensing actions." { 25 That to me implies that you're going to be tied l 1 i ( - - ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 1 1 l
32 1 down to this guidance document. It's the official policy'of () 2 the NRC, and you're going to use it in your review of 3 license applications. 4 CHAIRMAN STITT: Cathy? l i 5 MS. HANEY: The only thing we did do differently 6 -- that statement we did not go.back and look at. But if 1 7 you look in the text of the document,-when you get to each l i 8 subject area, previously it would've said, "
... submit your l 9 procedure or commit..." Let's see. "
... submit your l l l 10 procedure or commit to the model that's in Appendix..."
11 whatever. l 12 The document that you have right now says, don't 13 send anything in. So we've done it back there. But maybe 14 it's that sentence that needs to be at the front of the
) 15 document that needs to be looked at now, as compared to 16 focusing on the.back.
17 MR. SWANSON. Yeah. Fine. l 18 CHAIRMAN STITT: Go ahead. 19 MR. ZOON: And just as a perspective from a 20 Radiation Safety Officer's view, I've just been through 21 basically two license rewrites. And I would have to reflect 22 that the regional office does basically shoe horn you into 23 the guidance documents. If you propose some alternative 24 technique, no matter how scientifically defensible, it's 25 typically rejected.
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33 1 I think one.of the things we're coming to
' f( ) 2 synthesis on here is that - - and I was quite disturbed by l 3 even the latest draft - -
is that the regulation should ! f l 4 tell an institution or a program what to do. It should tell 5 a program how to do it. And that's the bottom line. 6 'DR. WAGNER: I'd like to support what Robert just 7' said. But I'd like to support from the point of view that i 8 the agreement states are just as guilty. And one of the i 9 problems is the agreement states live in fear, I guess, of 10 the NRC. And so they tend to look at those guidance i 11 documents as being regulation. So that they're sure that l
'12 they're living within the requirements of the NRC.
13 And I've had experiences where my policies and 14 procedures have been rejected, on the basis that they don't l ) 15 meet the guidance document. And I've objected that the i 16 guidance documents aren't regulation. They said, well, 17 that's okay. We're just not going to approve it. 18 CHAIRMAN STITT: I think we're hearing - - the 19 NRC is hearing some clinical experience; those of us who are f 20 taking care of patients day in and day out, and how we deal 21 with these. 22 Cathy, are you ready to move on? 23 MS. HANEY: I'm going to move on to the next area, 24 the Medical Policy Statement. 25 Let me tell you the purpose of the Medical Policy l l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
l I 34
- 1 Statement. It is really just to give NRC licensees, state
.,\
{
%) 2 and Federal agencies, and the general public, the 3 Commission's general intention of regulating the medical use 4 of medicine, or by- product material for medical use. So, 5 it is meant to be a general statement.
l 6 This is one of the subject areas that has l 7 generated a lot of comment over multiple meetings. i 8 What is in the blue folder that was at your desk, 9 are some copies of some viewgraphs. And what I have given 10 you is the current Medical Policy Statement. And, i 11 basically, it says, " Option 1, Status Quo"; I just used one 12 of my old viewgraphs - - in case you're interested in 13 referencing the - - oh, I'm sorry. It should - - it's 14 going to be in the package that starts out with, " Training 15 and Experience." So, thumb down about two or three pages 16 and you should see it. l 17 So, we have the status quo - - and I have copies l 18 of these viewgraphs. And if it becomes appropriate I'll put 19 them up on the screen, or we can talk from the slide -- 20- whichever you think is best, we can do. 21 We came - - we discussed multiple alternative to 22 the Medical Policy Statement with you last September. We 23 discussed it at the facilitated public meetings. 24 And then we came back and met with the Part 35 25 steering group, and came up with an alternative, which is a () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
l 35 1 four- item alternative. It's dated 2/98. l b) 1 2 One of the main changes there was a statement that 3 was in Number 3, "
...as to assure that the physician's 4 prescription is correctly delivered." l 5 And then, Item 4 is a little bit different from i
! 6 the current Medical Policy Statement. We discussed this l 7 with both subcommittee meetings. And I can't say that both l 8 -- either of the groups really liked it. 9 Is that fair? 10 CHAIRMAN STITT: Yeah, that's fair. 11 MS. HANEY: Okay. So, the - - I 12 CHAIRMAN STITT: We weren't sure we were going to 13 get anything done, because we couldn't get past the angst of 14 the Medical Policy Statement. l 15 MS. HANEY: So, what happened next is the 16 Diagnostic Subcommittee actually came up with another, a i 17 revised statement, which is the next copy that you have. 18 And but the therapeutic group really didn't; we just : 19 discussed, really keyed in on the issue of assuring that the 1 ( 20 physician's prescription is correctly delivered. 21 All right. So, I'm going to open it up for 22 general discussion. But one of the things that I would like 23 to get a specific answer to is, the issue of this i 24 physician's prescription correctly delivered. 25 There are those that see that as a very narrowing ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 w__ . _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ - _ _ _ __ _ - - - _ _ _ - _ _ _ - -
36 1 statement. That it is too narrow. But, yet, there are () 2 those that can argue it as, that is too broad; and gives NRC 3 the authority to go wherever it wants to go. And I would i 4 say, as a motive here, I have to write a Commission paper 5 that's going to forward the Policy up. So, I need something 6 to put in this paper that's going to say, you know, either 7 why this was accepted, or why it was not accepted. I 8 And with that, I'll turn it over. And if you'd ; 9 like, I can put any one of these alternatives up on the 10 viewgraph. ' 4 11 CHAIRMAN STITT: Cathy, do you want to talk about 12 any of the alternatives? What is the sourc'e of the 13 alternatives? Is it from the working group? Or just 14 something more recent?
) 15 MS. HANEY: Well, I guess - - right now what we l 16 are going forward with is the working group / steering group 17 alternative. So maybe in light of the diagnostic proposal 18 - -
say, Diagnostic Subcommittee proposal, you may want to 19 look at both of those and say either a thumb's up or thumb's 20 down, as a full committee, to the working group / steering 21 group alternative. Or, you know, give me that the 22 Diagnostic Subcommittee is the preferred route. 23 CHAIRMAN STITT: All right. So, our discussions 24 this morning then - - I need to see if I'm wording your 25- charge correctly: Discuss the working group / steering group [' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
37 1 alternative; contrast it to the Diagnostic Subcommittee. () 2 Do you want to speak how the two of them are l 3 different? Just briefly if I have one of the Diagnostic t 4 group - - 5 MS. HANEY: Dennis, do you want, should turn it to 6 you? Or you want me to do it? 7 MR. SWANSON: Well, go ahead. 8 MS. HANEY: Thank you. Darn, wrong answer. 9 MR. SWANSON: I can comment on it, if you want me 10 to. 11 I think what the Diagnostic Subcommittee was 12 trying to do, or where it mainly differs is in Statements 3 13 and 4, which were technically combined. And I think the 14 Diagnostic Subcommittee was really trying to tie the Medical () 15 Policy Statement through the words, "
...only where justified 16 by the risk...only where voluntary standards or compliance 17 to these standards are inadequate."
18 And then, further clarifying by the final sentence 19 that NRC's role is to assure that the prescription is 20 correctly delivered. 21 CHAIRMAN STITT: Well, you know, when I look at 22 these, we've spent lots of our meetings discussing the 23 Medical Policy Statement. And I know we, as a whole, had 24 only in there probably when we first started this task. 25 MR. SWANSON: It was trying to get back to the l () i ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
38 l' original ACMUI's statement that really -- [ 2 CHAIRMAN STITT: Right. When the Therapeutic 3 group met we had Barry Siegel on a phone conference with us. 4 And part of the reason for that was to get some of the 5 . background, because he spent so many hours working with the 6 working group. 7 And a number of us flared'up at finding NRC hooked 8 up in the same language with physician prescription. I 9 think it became very personal, quite frankly. Barry, in 10 trying to calm us down, was giving us the idea that this 11 narrows what the NRC supposedly would do. And that is to 12 see that whatever the physician wrote as a radionuclides 13 prescription was correctly delivered. 14 So, he was trying - - his commentary to the (~h (_;7 15 Therapy Committee that was meeting was that this is actually 16 a narrowing of the Medical Policy Statement. Some agreed, 17 some disagreed with that. So, that's kind of my perspective 18 on the background. 19 Cathy and I actual]y were going to put this on the 20 latter part of the agenda for the second day; until we found 21 that we could get Carl to attend. If she sort of - - I'm 22 speaking for Cathy, and I don't know-if this is necessarily 23 appropriate. , 24 But she hears from us over and over and over again 25 - -- as a whole, as a subcommittee- - and then interprets ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 o
39 1 it to Don Cool and to Carl Paperiello. And one of the ( ) 2 points of having him here was to enjoy our Sunday morning 3 together, but to hear straight from the folks in the 4 trenches, and not to have to have Cathy always be doing the
-5 interpreting.
6 So it's back on the very front part of our agenda 7 again. And I will just throw it open for commentary And 8 I'll try to keep the peace up here. 9 John? 10 MR. GRAHAM: I have a question to Cathy. Between 11 the ACMUI recommendations that are summarized in the tab 12 under, " Previous ACMUI Recommendations"? That is our 13 language, correct? The - - 14 MS. HANEY: Yes. 15 MR. GRAHAM: So, if you pull that page, compare it 16 to Option 1, which was the status quo, which has been on the 17 books since 1979, correct? 18 MS. HANEY: Yes. 19 MR. GRAHAM: Then, there's a working / steering 20 group alternative, which was put together by Staff, reacting 21 to our earlier discussion? 22 MS. HANEY: It was put together by working 23 group / steering group reacting to the recommendations of the 24- ACMUI, two public meeting - - three public meetings.
- 25 And any of the comments - - we got a couple of
() l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
40
.1 written comments.
( 2 MR. GRAHAM: But the working group / steering group 3 is primarily Staff of the NRC? 4 MS. HANEY: Yes, with some agreement State members 5 on there. 6 MR. GRAHAM: Yeah. And then there was a summary 7 statement in the packet handed out this morning for the 8 Diagnostic Subcommittee recommended modification. 9 Was there also a draft that also came out the - - 10 MS. HANEY: No. 11 MR. GRAHAM: No. Okay. 12 It would help me a great deal if vou could discuss 13 - - and it's the subtlety, I think, of what Barry was 1 14 trying to discuss at our subcommittee as well - - as to why l ("h. k
\m,) 15 the working / steering group thought we should add language i 16 that specifically linked any discussion of risk to the l t
17 ' patients with the physician's prescription. 18 Our recommendation coming out of the ACMUI meeting 19- was that the "NRC will regulate the radiation safety of j i 20 patients only where justified by the risk to the patient, 21 and only where voluntary standards or compliance with these 22 standards are inadequate." Then, it was when it went to the 1 23 working group that this language about the physician's 24 prescription got added. 25 And I have heard a discussion that this was to i () ANN RILEY & ASSOCIATES, LTD. Court Reporters ( 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 (202) 842-0034
41 1 benefit the medical community by making it very restrictive, 2 and defining a very limited scope where the NRC could become 3 involved. I don't understand that, though. 4 So could you explain how this makes it more 5 restrictive? How this limits the scope greatly? And how 6 this is a good thing? 7 MS. HANEY: I'll try. The concept to ensure the 8 physician's prescription is correctly delivered came about 9 in the September meeting of the steering group. This was 10 one of the options for the Medical Policy Statement that the 11 steering group developed. 12 From'that it became the fourth alternative for the 13 Medical Policy Statement that went out in the packages that 14 went for the facilitated public meeting. So that's how 15 those words actually came about. 16 Then we went into the discussions at the different 17 workshops. And coming back from those meetings - - and 18 there were some steering. group members present at the public 19 meetings - - and then, of course, they had the benefit of 20 transcripts that we have, and then, just the Staff's telling 21 them what we heard. 22 The steering group felt that it was a limiting i 23 statement. That it said exactly what NRC was going to do. 24 That our role is obviously radiation safety. But how far 25 does radiation safety go? ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l l (202) 842-0034 l l
42 1 They felt that by saying that our role was only to (O) 2 assure that the physician's prescription is correctly 3 delivered, basically says we're not' going to tell you how to 4 write the written- - well, we're not going to tell you, you 5 know, how many RADS should be delivered to the patient. You 6 know, how many fractions. Anything like that, we will stay 7 out of it. i 8 Our role comes in at the point of once you say 9 what you want that individual to get, that's where NRC 10 regulatory authority begins. And, of course, then you look 11 at it in light of risk where that in the - - and it's 12 easier just to give you an example - - is in the diagnostic 13 area that the risk is low; therefore, we would not expect as 14 many regulations, as compared to the therapy area where the () 15 risk is higher. Therefore, we would have probably more 16 regulations in that particular area. 17 CHAIRMAN STITT: John, do you have any rebuttal 18 comments on that? 19 MR. GRAHAM: Well, just one point of 20 clarification. I think to summarize the discussion that 21 occurred for hours at some of the earlier ACMUI meetings, 22 the original policy statement - - and it may or may not 23 have any effect on the regulations that get developed - - 24 stated that the NRC will minimize intrusion into medical 25 judgments affecting patients, and into other areas [ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300
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43 1 traditionally considered to be part of the practice of 2 medicine.
.3 I think the difficulty that I listen to clinicians 4 describe was the fact that the reality of regulation over a 1
5 20- year period of time didn't reflect that statement. 6 That's a great statement. I mean, as a policy statement if 7 the NRC truly minimized its intrusion into any medical 8 judgment, anything that was related to the practice of 9 medicine, we wouldn't have been having this debate. 10 But the reality was, I think as Barry described 11 it, a yo- yo, or a reactive form of regulation where if 12 there was a problem, if there was an accident, suddenly 13 regulations were being developed. They tended to be 14 developed very rapidly. And then they tend to have side (' ,,f) 15 effects that aren't apparent, that affect in an adverse way, j 16 the practice of medicine when it involves by- product l 1 17 material. 18 So it was the word, "
...the NRC were only regulate 19 where there's a clear risk to the patient...". The word, 20- "only" was debated at length, and finally agreed to because !
21 it'was attempting to in policy create guidance that would 22 give you a benchmark to consider whenever evaluating a 23 regulation that you had to pass a threshold where there was 24 a clear risk to the patient before any regulation would be 25 considered. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
r--------- - - - - - - - - - - - -- ------------ - - - -- - - - - - - - - - - - - - - - - - - - - - - - - 44 1 And adding this phrase that says that, you know, 2 (A) it will "... regulate the radiation safety of patients to 3 assure that the physician's prescription is correctly 4 delivered..." starts us down a slippery slope that opens up 5 anything and everything related to that physician's i 6 prescription, I think. 7 CHAIRMAN STITT: Well, I think that's where - - 8 MR. GRAHAM: That's my - - ! 9' CHAIRMAN STITT: -- I jumped into this. It makes i 10 it sound like next the FDA's going to be there to regulate L 11 semetadine I'm prescribing. Or the tetracycline. I 12 Cathy, is prescription in all that list of 13 definitions that we have? We've always talked about written j 14 directive, and we use all sorts of phrases, and here we have
) 15 prescription. Is it the first time it's on the list?
l 16 MS. HANEY: Yes. J 17 CHAIRMAN STITT: All right. Is - - 18 MS. HANEY: Like, it's for the first time. I 19 think - - 20 CHAIRMAN STITT: Right. And so that's a bother to 21 me, too. We've got prescription that sort of stands alone, ! 1 22 and doesn't relate to anything else that's in the document. 23 And again, I- - just on face value - - when you open up ; 24 the book and start looking, you see Medical Policy 25 Statement, NRC and physician prescription. And those are () ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters i Washington, D.C. 20005 (202) 842-0034
I 45 l 1 not user- friendly interactions to a physician. () 2 Jeffrey? L 3 DR. WILLIAMSON: Yeah, I guess I'd like to make 4 two comments about it. First of all, I don't see where 5 there is very much benefit to at least the therapy community 6 in the way you've rewritten the Medical Policy Statement. 7 I'm not really aware where NRC in the past has 8 ever dictated the indications for brachytherapy treatment, 9 for example, except in a very general sort of way. And I 10 think it's good you've changed that. 11 I know in current Part 35 it says the various 12 garden- variety radionuclides will only be used for 13 interstitial transluminal and inter- cavitary therapy of 14 cancer. Maybe that's one example.
-fN \_ l 15 But it's really the only one I can think of where 16 in past regulation has actually constrained the physician's 17 ability to prescribe therapy.
18 So, what is the benefit of, you know, saying 19 you're going to continue doing this in the future? That's 20 one comment. So, I don't see there's a gain. 21 The second comment is that physicians are 22 intimately involved - - at least in the therapy area - - 23 in determining whether their prescriptions are satisfied. 24 So, you know, they're very - - in radiation oncology it's a j i j 25 team effort with usually the physician playing the 1 l l () ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 ' Washington, D.C. 20005 l (202) 842-0034 : o t
46 1 leadership role in these regulations that you would make to (( ) 2 assure that this is correctly delivered would substantially 3 constrain the physician's behavior. l 4 So there's an awful lot that will indirectly l l 5 influence the practice of medicine. And, in fact, I think l 6 in therapy it's fair to say, setting up the very detailed 7 process and procedures for delivering a complicated therapy, l 1 8 you know, really has fallen traditionally into the practice 9 of medicine. And it's one of the major areas that radiation l 10 oncology training focuses on. Okay. So there's a lot of 11 constraining being done. l 12 And I think the third point, I would agree 13 completely with John. This one really just doesn't tie down i 14 enough to risk. There's no suggestion that there's a risk j 15 threshold before specific regulations can be made 16 constraining the way in which therapy is delivered, or the 17 kinds of checks that have to be made. 18 So I think inclusion of the word "only" would be 19 very good. And I think if you can refer back to past 20 discussions, we wanted to put a phrase in there which 21 defined a threshold of risk that was comparable to that of 22 other major subspecialties, or forms of medical practice, 23 outside of radiation medicine. 24 CHAIRMAN STITT: Dan Flynn, you had comments? l 25 DR. FLYNN: Yeah. This is also to Carl also. In I () ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 l (202) 842-0034 l l_ _ _ . -. _ . _ . _ . _ _ _ _ _ _ _ _ _ _ . . . . _ _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ . _ . _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
i 47 1 terms of the way tnis is written now, if you step back just () 2 for a second and think of just eliminating 3 completely. 3 But then, in Section 2 where it says, ... provide for the " 4 radiation safety of workers, general public, and the 5 patients themselves..." Then if you add, "the patients 6 themselves" at the end of 2, you can eliminate 3 and not use 7 the prescription. 8 It doesn't really - - this is a Medical Policy ) 9' Statement. It's a broad statement. It doesn't limit the I 10 NRC's role in terms of it there are unsafe practices due to 11 a prescription or written directive not being delivered, 12 because of the radiation safety of the patient. Because 13 then you've - - I agree with what Jeffrey and Don have
- 14. said.
) 15 It's the, you're concentrating on the radiation 16 safety of the patient in terms of the use of the radio 17 isotopes. So then if you add that as a part to Paragraph 2 18 by putting, "
... radiation safety of workers, general public, !
19 and the patients themselves..." then it sort of links that i 20 all in together, without getting involved in the word 21 prescription specifically. 22 CHAIRMAN STITT: Well, I'm going to make a comment l 23 because I have the mike, and then I'll start down that way. ; 24 The thing I keep coming back to is physician 25 prescription, we keep talking written directive, where we s 1 O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034
48 1 have a lot'of.other words that we use in this large text. j
) 21 And all of a sudden, we see " physician prescription" for the 3 first time ever. It doesn't relate to the Part 35.
4 If the NRC's looking at written' directive, why is 5 that not in there? How did we come up with physician 6 prescription? 7 Because they're different. Written directive in 8 the new 35 has some very specific points to it. Physician 9 prescription also includes a whole variety of things: using 10 the belly board; displacing the bowel; just - - I mean, I 11 could go on and on and on and on. And there's some 12 qualitative - - this can be so qualitative, and I think in 13 the past we've been looking at more quantitative 14 information. 15 MS. HANEY: I'm not sure that there was a specific 16 reason for using prescription, rather than written 17 directive. Other than, by using prescription it was maybe a 18 little bit broader than using the term, " written directive." 19 And then I would offer as maybe the solution to 20 this, to say that the " physician's written directive is 21 correctly delivered." Does that answer the question about 22 risk? 23- CHAIRMAN STITT: Well, I'm not sure. But at least i 24 it's rephrasing what you're going to read as you read - - ! 25 if this is the thing that precedes Part 35. And it is. ! l I g ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i L;____ _ - - _ _ _ _ _ _ _ - _ - _ _ _ - - - - _ - - _ _ . _ _ _ _ _ - - _ - - _ - - . - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
7 49 1 That's the first - -
). 2 MS. HANEY: That's right.
3 CHAIRMAN STITT: -- page in the little tiny print. l i. 4 At least it relates to the text that you're going to come up l 5 with. So, I'll raise that as a question and a concern. r l 6 . Carl, and then we'll go down this side of the 7 table. 8 DR. PAPERIELLO: I'd just like to make one l 9 observation. The fourth statement up there, as written, is
- 10. very close to the directions the Commission has already 11 given the Staff in one of the DSIs - - I think DSI 11, but 12 I won't swear to the number - - corrections setting issues 13 as part of their strategic assessment, which would not just 14 involve the medical industry, but essentially, every area we
) 15 regulate. And this ventures views the industrial and, you 16 know, census standards as define approaches to meeting a 17 performance- based requirement.
18 So in some sense I did make the observation that ! 19 that fourth statement up there is unnecessary. 20 CHAIRMAN STITT: Okay. Go ahead, Lou?
- 21. DR. WAGNER: Wall, I guess I'm very perplexed, as 22 usual when we get into these discussions. I have a l.
23 question, and then I have some, perhaps, proposed 24 alternatives. l l 25 What radiation safety aspects of the patient'does ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
50 1 the NRC wish to regulate? What are the radiation safety () 2 aspects you wish to regulate of the patient? 3 The patient's going to be delivered, especially in 4 therapy procedures, very large doses of radiation under a 5 doctor's prescription. What are you trying to do with 6 regulation? 7 DR. PAPERIELLO: What if it is not delivered? 8 You're right, it's an extremely large dose relative to 9 anything you would use in the area of radiation protection, 10 and if, in fact, what happens is not what is intended, and 11 it deviates that by a very large amount, obviously that 12 poses a significant threat to the patient. 13 I'll flip it the other way around. Look at part
-14 20. Part 20 exempts - - in other words, we have radiation 15 limits. The licensees are exempted from those radiation 16 limits insofar as they are prescribed medical exposure. Now 17 if, in fact, the medical exposure is not what is prescribed 18 or given in a written directive or whatever, and is 19 something other than that, why shouldn't I consider that an 20 over- exposure in light of part 20, other than the fact to 21 say that once a person becomes a patient, they no longer j i
22 become members of the public and are no longer entitled to 23 the protection of part 20. 24 . You know, there is a tension there. I understand, 25 - there is a tension there, and I would say that the areas () l i ANN RILEY & ASSOCIATES, LTD.. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 I
! (202) 842-0034 j l
i 51 1 where we are interested in regulating, are interested, have () 2 a concern, is when, in fact, what happens is not what is 3 intended. In other words, if you choose a wrong therapy but i 4 it is delivered as you chose it, then I guess from my 5 viewpoint, my personal viewpoint, that's a medical issue, 6 okay? 7 If you chose to irradiate a right lung and, in 8 -fact, what was irradiated was a left lung, that seems to be 9- sufficient deviation that it would be our interest, okay? 10 I'm just saying - - 11 DR. NELP: That's certainly a medical issue if you 12 are negligent or do improper therapy. That's not a safety 13 issue, that's a medical issue. 14 DR. WAGNER: Yes. I wanted to go on with mine 15 because I wanted to ask that question and then I wanted to 16 develop that issue, because I think this is the core of what 17 we're trying to achieve here. j 18 Now, if that's what we're trying to do, Carl, it 19 seems to me that the original three medical policy
- 20 statements proposed by the ACMUI are the most appropriate 21 because the original three of the ACMUI, number three states 22 that you regulate radiation safety patients only where 23 justified by the risk, and only where voluntary standards or j 24 compliance with these standards are inadequate. Assessment l 25 of the risk just finds such regulations will reference ANN RILEY & ASSOCIATES, LTD.
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52
- 1 comparable risks and comparable voluntary standards and
,-(A) 2 _ modes of_ regulation for other types of medical practice. l 3: .And that really hits the core of the issue right there. 4 Now, it seems to me that we're getting away from
'5 the whole nuts and bolts of what we're trying to_do here, 1 6 and that's why I wanted to ask that question: WhatLis it 7 you want to regulate? Because that's what the policy should 8 reflect, and it seems to me those'first three statements 9 proposed by the ACMUI as the modifications to the medical 10 policy statement really hit it on the head.
- i. 11 Now, the only other_alte.rnative that I can see, 12 but it's not going to be the appropriate one according-to 1
13 what you say because you're afraid that, for some reason, l 14 the medical practice is going txt go out there and start
T
/ 15 making an excessive number of things beyond the standard i 16 mistakes of medical practice, the standard frequency which 17 they occur despite all our attempts to have a perfect 18 society - - but there is some concern that perhaps the i 19 radiation delivery to patients is going to get'out of 20 control and it will be a lot of misadministration to wrong 21 ' sites or wrong areas or terrible things happen. If that's 22 the case, it seems to me we've just got to go back to the 23 recommended ACMUI statements, the original three, and that L24 has to be our proposal. l 25 CHAIRMAN STITT: I think, Jeff, you had your hand l
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53 1 up a while ago. A ( 2 DR. WILLIAMSON: s- ) Yes. I think another - - I just 3 wanted to remind the group, a point that came up in the 4 therapy subcommittee meeting in early February revolved 5 around the word assure, and this seemed to be suggesting 6 that the NRC was continuing to or would be disposed to take 7 as its goal kind of an unrealistic standard of perfection, 8 that ten to the minus fifth or ten to the minus fourth as a 9 risk factor is not acceptable; it's got to be zero, ten to 10 the minus eighth or something like that; just one incident 11 is enough to create a sort of Barry Siegel yo- yo type 12 effect, another regulation based on a highly improbable 13 single event. 14 So to follow up, so I think we're happier with () 15 words " confer high confidence" or something l'ike that, but 16 this does relate to Lou's point and why ACMUI all of these 17 years has been insisting on focusing on risk relative to 18 other medical sub- specialties is that a concern the 19 regulated community has is that regulations and NRC seem to 20 be driven and formulated in response to single highly 1 21 improbable incidents, which, you know, do occur from time to 1 22 time, and this tends to have a sort of a warping effect on l 23 our industry standard quality assurance programs, if you 24 want to call them that, forces us to focus a lot of effort 25 and attention, time and resources on relatively improbable ['/l N-ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 , 1
l 54 1 events, sometimes at the expense of more garden variety () 2 3 concerns that really, on a day- to- day basis, impact quality of patient care more. 4 So in a sense, to do this, to turn upside down the I 5 hierarchy of priorities, you know, doesn't necessarily serve 6 patients well. 7 CHAIRMAN STITT: Dr. Cerqueira? ! 8 DR. CERQUEIRA: Yes. I sort of - - you know, 9 I've heard this discussion so many times, and I still can't 10 quite seem to get the handle on it. But I think we have to 11 see'this in the context of which I as a cardiologist would 12 manage a patient and some of the things that I could 13 potentially do in how that's regulated. 14 As a cardiologist, I could give a person 30
) 15 milligrams of adenosine bolus, which would make his heart 16 stop, but there's no federal regulatory body which is coming 17 in there and is looking at how I do that, but there are 18 professionals, there's hospital standards that will regulate 19 and prevent that from happening.
20 If I do a'catheterization, I can put my foot on 21 the fluoroscope pedal and I can radiat3 that patient
'22- extensively, and there are certain standards and guidelines, 23 but they're not of this magnitude that we have seen in terms 24 of the Nuclear Regulatory Commission.
25 I can take a catheter in that patient and I can l' ANN RILEY & ASSOCIATES, LTD. b Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 _ _ _ _ . . . . _ _ _ _ _ - _ _ - _ _ _ . _ . _ _ _ _ -A
l l l-l 55 1 sort of whip it around the heart, creating all kinds of 2- arrhythmias, dissecting coronary arteries, which would cause [Vl l 3 the patient to have fatal arrhythmias, would cause the 1 4 patient to die, and I'm not regulated other than through 5 professional standards and again through the hospital 6 policies that are in place. 7 If I look at - - as somebody who does nuclear
- 8 cardiology, if I want to give the patient a 30 millicurie 9 does of technetium, I have unbelievable numbers of 10 regulations that I have to go through - - wipe tests, all 11 kinds of checks and balances that are put in there - - and 12 if I look at the risk of giving that 30 millicurie 13 technetium dose versus giving the patient adenosine versus 14 radiating the patient with fluoroscopy versus dissecting l 15 coronary arteries, creating arrhythmias, we're talking about 16 very low risks.
17 If I want to try to prevent a patient who we've 18 performed a therapeutic intervention on to prevent 19 restenosis by putting in a train of strontium beta- emitting 20 beads and - - to prevent restenosis, again, the regulations ; 21 that are going to be imposed are unduly restrictive and 22 really don't add substantially to the safety of the patient, 23 the public, or to myself. 24 So I think if we really focus on all of the things l 25 that we do in medicine or all the things that I can do as a ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
56 l 1 cardiologist and how they're regulated versus my () 2 administering a 30- millicurie dose of technetium or using 3 strontium 90 beads for therapy, it is really out of 4 proportion. l l 5 You know, I think, as you said, when you're 6 talking about rm ulating reactors, it's'a different ! 7 situation if we look at the whole concept of risk, and I 8 think we have to take that into account, which is why to 9 regulate the physician's prescription is totally l 10 unprecedented in all other areas of medicine in which I as a 11 physician work. l 12 CHAIRMAN STITT: Beautifully spoken. l l 13 DR. PAPERIELLO: And I will make an observation. l 14 The statement may apply to all radiation in the United 15- States, but I have to live with it. Pure and simple. I 16 Obviously you're all aware of the incident that occurred at
- 17. NIH where an individual ingested P- 32, whatever event. If 18 -that individual had been run down - - deliberate act - -
! 19 had been run down in a parking lot with an automobile, it i 20 would have never had the attention, I would have never been 21 up on Capitol Hill on the incident. 22 The fact of the matter is, I live in a society i 23 which does not see the risk from radiation in the same light ! l 24 as risk from other things. That's number one. Actually, in < l 25 terms of risk from radiation, the medical community is seen 1 i l () ANN RILEY & ASSOCIATES, LTD. Court Reporters J 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 ; (202) 842-0034 ) L_________.____.____ _ _ . _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ . _ . _ _ _ . . _ _ . _ _ . . _ _ _ _ _ _ _ . _ . _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ . . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ ___b
l 57 1 more favorable than other things. We're involved with I f () v 2 arguments with the EPA over regulation of radioactive i 3 material and groundwater at doses that are fractions of a 4 millirem a year. I mean, I hear what you're saying. 5 The Commission has made a decision on what we're 6 going to regulate and to a certnin extent the degree based 7 upon political views. I mean, it is, in fact, a political 8 -- they are political appointees representing the people 9 of the United States. 10 You're right, I had a heart scan some years ago 11 and realized the least risky part of the whole procedure was 12 the radionuclides injection. I understand that, but l 13 unfortunately, I have to regulate to a risk or even a 14 perception of risk which is driven by society, okay, and not I () 15 necessarily what I might view as acceptable risk as a 16 scientist. I mean, that's a factor. And the Commission has i 17 made decisions. i 18 Obviously, the National Academy of Sciences gave 19 the Commission an opportunity to say, we're not going to 20 regulate in this area at all. The Commission did not make 21 that decisions. 22 So I hear what you're saying. I'm trying to come 23 out with something, what can we - - in a relative scale of 24 risk, what can we turn around and can live with that makes 25 some kind of sense. The fact of the matter is, we had l ANN RILEY & ASSOCIATES, LTD.
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l 58 l 1 Congressional hearings, Congressional hearings which I A I 2 participated in on medical misadministration several years j 3- ago the.t probably, in the course of the hearings, the actual 4 time we spent on Capitol Hill, more people were run down in 5 automobile accidents than have ever been done in the whole 6 history of medicine. 7 I'm just - - but that is the environment in which 8 I have to work, and so therefore - - I gave a presentation
- 9 on this, a short one, in Seville, Spain, back in November 10 dealing with risk, the aspect - - it dealt with the effects 11 of low- level radiation. We're dealing with - - you know, 12 diagnostic doses are well above low- level radiation that we
{ 13 have to worry about when we deal with cleaning up the 14 environment. And the IAEA made a representation that people Q 15 will tolerate risk in the order of ten to the minus four per 16 year, and I basically said you're wrong. 17 What people will tolerate as a risk is a function 18 of a bunch of things. Is it avoidable? Who benefits and 19 who pays? And the other aspect is, is it an unusual way of 20 dying or suffering? And for some reason or other, radiation 21 has had a perception as a particularly bizarre way of being 22 injured, and that affects society's, you know, attitude 23 toward radiation. j 24 I've had cases where we had a tritium sign break 25 and release tritium gas, sorc.e becomes tritiated water, doses ANN RILEY & ASSOCIATES, LTD. , Court Reporters ! 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 i
l 59 i I 1 involved in a few millirem. Tens of thousands of dollars (/1 x-2 were spent on cleaning up. You wouldn't even have to clean
-3 up. I would have cleaned up, from a technical viewpoint, of i
4 just laundering this thing. Instead, the material is
- 5 disposed of as radioactive waste.
6 I'm telling you, that's the environment we - - I i l 7 mean, given the societal environment, that's the environment l l 8 the Commission has to work in in which to regulate the use 1 9 of radionuclides in medicine, and so the business of - - it l 10 would be very nice - - I would like it very - - I would l 11 like to say, hey, people accept 40,000 deaths a year in ' i 12 automobile accidents; that's a good number to work with. I j 13 You can't do that, and we don't. We have to respond to what 14 the public wants in terms of radiation safety, and the fact O) i (,, 15 of the matter is, in the medical side of the house, we 16 actually are accepting higher doses than we accept any other ! 17 place. Patient release - - you're releasing patients and 18 irradiating members of other - - non- patients at levels 19 that don't meet acceptable environmental standards in the 20 United States. 21 CHAIRMAN STITT: I want to tell you where we are l 12 2 because we're getting short on time. It's 9:30 and we need 23 to discuss other things that we want Carl to hear between i 24 now and the time we finish this morning. So any people who ; 25 have not had an opportunity to comment on the medical policy l r3 ANN RILEY & ASSOCIATES, LTD. Q' Court Reporters 1250 I Street, N.W., Suite 300
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I I 60 : 1 statement, make sure you raise your hand and then we're ; !O 2 going to close off the session shortly. 3 So we'll start with Ruth. l 4 DR. McBURNEY: I can certainly appreciate what ! 5 Carl is saying, because in state programs as well, we have 6 to react to what the public are wanting in the way of i i 7 regulation, and there have been several times that, even in l 8 the area of medical regulation, that we have been asked to i 9 be even more restrictive than what NRC has. h 10 I think that in the way of looking at number i 11 three, you're still looking at a risk- based or 12 risk- informed type of decision whether it says where 13 justified by risk to the patient or only where justified by j 14 risk to the patient, and in looking at, you know, the l
/s
( ,) 15 regulations in part 20 and comparing that to what is under j 16 the written directive of a physician, if it goes outside 17 that because of - - and we're mainly talking about therapy 18 here - - because of a miscalculation over a long period of 19 time or a malfunction of a machine, these things can take ! 20 place, and therefore, the radiation safety to the patient 21 would be at risk and they deserve as much protection on 22 radiation safety as the other members of the general publ.ic 23 would be in those situations. { 24~ CHAIRMAN STITT: Naomi? 25 DR. ALAZRAKI: Two comments. First on what Dr.
\
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I
.61 1 Paperiello just said, I think that what you said dramatizes
()
/i 2 to me the long overdue need for the NRC to be launching a 3 major education, public education campaign to educate the 4 public about radiation since that seems to be one of the q
5 major - - the major factor,.from what you just said, that 6 commits NRC to this excessive radiation relative to risk 7 that we're all talking about. 8 So I think perhaps the downgrading of regulation 9 which we're trying to do will be benefitted from a major 10 public education about radiation campaign, and then you may 11 be able to feel a little bit freer to go this route. 12 Second, I think the issues of radiation safety, 13 regulating radiation safety of patients and trying to be out 14 of the practice of medicine are almost mutually exclusive. l } 15 The radiation safety of the patient is so tied to practice 16 of medicine that I don't see that you can do one-and not.the 17 other, or whatever. 18 Somebody made a comment at our subcommittee 19 meeting that there is actually a statutory standard in the 20 Atomic Energy Act which would be met only if the - - when
- 21 the prescription or written directive of a physician is l 22 correctly delivered, something to that effect, that somehow 23 in that Atomic Energy Act, the Commission is somehow bound 24 to - - I don't know if I'm misstating that, Kathy, but 25 somebody said that at our subcommittee meeting. I would ANN RILEY & ASSOCIATES, LTD.
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62 1 like to get to the bottom of that if that's true. I 2- But as far as regulating radiation safety of 3 patients, I think you're well into practice of medicine when 4 you try to do that no matter what you try to do. 5 DR. PAPERIELLO: Can I address your first point on 6 educating the public. That.is perceived by a lot of people j 7 as promoting. That is'a practical problem. It is perceived 8 as promoting. I would point out to the medical community, 9 you have an opportunity, there will be started in the next 10 couple-of years, if not sooner, a revision by the BEIOR ) 11 committee of the National Academy of Sciences on the health 12 effects of radiation. I think that is an opportunity, an l i 13 outstanding opportunity for the medical community to turn f l 14 around and try to get the National Academy to adequately I D
-() 15 describe risk.
16 The problem you have is this: the accepted 17 paradigm in the health effects of radiation is a linear' dose 18 model, and that is an issue of risk. assessment, and that is
- - 19- pretty well accepted in the international community, it is l 20 accepted here in the United States by the National Academy 21 of Sciences, at least the previous couple SEIOR reports, 22 it's accepted certainly by the EPA, it's accepted by the NRC j 23 when it does its risk assessment for any radiation effect.
24 The other side of risk assessment is risk 25 management, and that is the decision of what level of risk ANN RILEY & ASSOCIATES, LTD. Y Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
L 63 1 is acceptable. A practical matter is, is that is not a () 3 2' scientific decision. It tends to be'- - I don't want to ! say - - I don't say political in a bad sense; it's a l 4 societal. decision on what is acceptable, and unfortunately, 5 it is not fixed, it'is a moving target. 6 You know, we all know that people will take risks 7 which most of us-wou3d perceive high. I mean, you wouldn't 8 get me on a motorcycle, you know, but there are people who 9 will motorcycle and will do it without helmets, and to me, 10 that seems to be an unacceptable risk. On the other hand, I 11 probably would take a few rem of radiation and not worry 12 that much about it, but there-are some people who, if it's 13 any dose at all, they won't accept it because it's - - in i L 14 other words, you can explain, you know, I can lay out data
) 15 and people will do things that are risky behavior.
16 So I just want to put . - - you know, educating 17 people on the risk of radiation, what would I tell them? 18 About the only thing I could tell them is this is the - - 19 the National Academy of Sciences says the risk of radiation 20 is this much and it's linear with dose and independent of 21 dose rate. I'm just saying that's what they will say. 22 That, we can't - - I can't do a whole lot about. ! l 23 The Atomic Energy Act gives the Commission sc a l 24 very broad authority. The Commission is using the policy 1 25 ' statement to try to figure out how that authority ought to I l O( j ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i I
64
- j. l' be exercised, and the tendency, the inclination of the I 2- Commission in the past and I think still now is where there 3 is clearly medical judgment - - in other words, what 4 therapy should I choose, what diagnostic procedures I wrould 5 choose and things like that, that's clearly medicine. If 6 it's delivered correctly, it's none of our business.
7 The issue is when it is delivered incorrectly, at 8 what point -- remember, one time we were involved - - you 9 had to report diagnostic misadministration. The Commission 10 has made a decision that that risk was low enough that that 11 didn't have to be done. The question now is and the 12 Commission - - and the Commission has certainly made a 13 decision no, we're not going to abandon the area completely. 14 What can we do that makes - - within the paradigm I have to
- l. 15 live in, what makes sense, you know? What is implementable?
16 And of course, Commission has made a lot of other decisions 17 independent, you know, risk- informed performance- based 18 regulation and, where possible, use industry and consensus 19 standard. Now, how do I fold that into this particular 20 problem? 21 CHAIRMAN STITT: We are running out of time, and j 22 what I want to do is to try to get something that is a j 23 consensus of the ACMUI on the book, and what I would like to , 24 do is focus on number three because it's a particular hot { i 25- button, what all of the sub- groups keep talking about. So ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 ! (202) 842-0034 L___.___.___
65 1 that's where we are in our last few minutes.
/3 i) 2 We have at least an hour that we must take to 3 discuss training and experience, and it will probably 4 require more than that.
5 MR. GRAHAM: I would like to recommend, and I'm 6 working off the medical policy statement of the 7 working / steering group alternative, the staff's collective 8 input as I understand it, I would recommend that statement 9 number one, "The NRC will continue to regulate the use of 10 radionuclides in medicine as necessary to provide for the 11 radiation safety of workers and the general public," would 12 be recommended by the ACMUI. 13 Statement number two, "The NRC will not intrude in 14 the medical judgments affecting patients except es necessary k) s- 15 to provide for the radiation safety of workers in the 16 general public," I would recommend, in light of all the 17 discussion, that we would agree with that. 18 Item number three, I would recommend that we go 19 back to the language that was approved at the last ACMUI, j 20 "NRC will regulate the radiation safety of patients only 21 where justified by the risk to the patients and only where 1 22 voluntary standards or compliance with these standards are i 23 inadequate." I 24 I would concur with staff's recommendation to add l 25 number four, which was that, "The NRC, in developing a
/~'s Q
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O 66 o 1- specific regulatory approach, will consider industry and () 2 professional standards that define d ceptable approaches of 3 achieving radiation safety." 4 I think as Carl mentioned earlier, that's in a O U 5 c o DSI. What we're saying is that that statement is so 6 appropriate and so importaE that we're recommending it h' o o 7 would be in medical policyv statement that does provide some 8 guidance to the NRC in these matters. 0 O C 9 I would make that as a motion, g
.10 CHAIRMAN STITT: Is there a second? Anybody 11 seconds? Do we have discussion?
12 DR. ALAZRAKI: Am S allowed to? 13 CHAIRMAN STITT: What was that? Oh, you can't. 14 Almost. Hang in there.
\ 15 A second?
16 DR. WILLIAMSON: Second. 17 CHAIRMAN STITT: Jeff. All right. n 18 Discussion? Lou'. 19 DR. WAGNER: John, when you said that the original 20 number three wording should be put into item number three, 21 you left off the second sentence to that. Did you 22 intentionally mean to leave off the second sentence of item 23 number three? 24 MR. GRAHAM: I felt that the number four that was
- 25 added in the working steering group was a compromise that O ANN RILEY & ASSOCIATES, LTD.
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67 l 1 got the same concept into the policy. It actually breaks it () 2 off as a separate piece. 3 DR. WAGNER: I don't think it does. I think it 4 avoids the issue that - - the whole point here and the 5 whole change, the real crux of the change, the '79 policy 6 statement, to me is the fact that these things have to be 7 assessed - - that the basis of regulation has to be 8 assessed on the basis that there are comparable risks and 9 comparable voluntary standards and modes of regulation for 10_ other types of medical practice, that we reference those, 11 _and the whole idea there - - that, to me, is not stated l 12 specifically in item four, that mostly - - that mostly just 13 -- that could apply - - that could mean that that's just L 14 applying to members of the public and the workers and stuff. ; k 15. But this is really very specific, the fact that if 16 you have a misadministration to the wrong site and it 17 occurs,.that if it is just a - - if it is an event that is 18 very unusual and very rare, that that should be assessed as l 19 to whether or not the regulations are sufficient relative 20 to, say, whether surgery, performed surgery is doing the
-21 wrong things, how frequently does that occur in medicine and 22 how frequently does anesthesiology do the wrong things in j 23 medicine that have severe consequences to patients. To me, l
L 24 that's what that's saying, that second sentence, and that's 25 not what is said in four. ANN RILEY & ASSOCIATES, LTD. Court Reporters ( 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
68 1 MR. GRAHAM: I think Lou is offering a friendly () 2 amendment to include the second sentence from che original 3 recommendation of the ACMUI in item number three, and I 4 would accept that. 5 CHAIRMAN STITT: I think it needs a second. 6 DR. WILLIAMSON: Could you read your version of i 7 statement three again, John? 8 MR. GRAHAM: Statement three would literally, 9 then, read, as we published it in the September meeting, 10 that the - - 11 DR. ALAZRAKI: It's in the book. 12 MR. GRAHAM: Yes, it's in the book, it's under the , 13 tab Previous ACMUI Recommendations. It's on page 1 of that, . 14 . item number three, "The NRC will regulate the radiation
) 15 safety of patients only where justified by the risk to the 16 patients and only where voluntary standards or compliance 17 with these standards are inadequate. Assessment of the
- 18 risks justifying such regulations will reference comparable 19 risks and comparable voluntary standards and modes of 20 regulation for other types of medical practice."
21 CHAIRMAN STITT: Now, that needs a second because 22 that was an amendment. Anybody? 23 DR. SNANSON: I need some rules of order. Can we 24 open that up for discussion without a second? 25 CHAIRMAN STITT: I don't think so. ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
69 1 DR. SWANSON: Then I'll second it so I can discuss () 2 it. ! 3 CHAIRMAN STITT: Yes, sir. 4 DR. SWANSON: The problem with that statement, if 5 anybody read the draft preamble to the revision of the 6 regulations, and I quote, "The Commission rejects regulation 7 of the medical use of byproduct material on the basis of 8 ' comparable risk' as ABS has essentially - - this is 9 American Association of Brachytherapy, Society, ABS - - 10 CHAIRMAN STITT: ABS. 11 DR. SWANSON: Uh- huh. "
. . . as ABS has 12 essentially proposed. The Commission doubts that such an 13 approach would meet the statutory standard in Section 161(b) 14 of the Atomic Energy Act of 1954 as amended to regulate all
) 15 uses of byproduct material 'to protect health and minimize 16 danger of life.'
17- "The Commission as well as others, such as the 18 National Academy of Science and the ACMUI, has recognized a 19 lack of acceptable data to compare the risk for medical use 20 of byproduct material to risk in other medical modalities. 21 In addition, there is not an express authorization in the 22 Atomic Energy Act to regulate any use of byproduct material 23 on the basis of ' comparable risk.' Justifying the 24 significant departure from the Commission's established 25 policy with respect to risk to patients would be at a f ANN RILEY & ASSOCIATES, LTD.
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70 1 minimum problematic." (Oj 2 So the Commission has definitely taken a look at 3 that statement and rejects it. 4 CHAIRMAN STITT: That's right, and I was curious 5 to see if anybody was going to bring that up here. We can 6 make our statements as we want to, which is why I've kept 7 that to myself. 8 Cathy? 9 MS. HANEY: Let me just add, that is a working 10 group document, so it's got words in there that - - I mean, 11 don't take that as final. But again, the working group has 12 been marching along to meet due dates, and so that is a 13 draft. 14 DR. SWANSON: A clarification: Has the Commission 15 truly made those statements regarding comparable risk? 16 MS. HANEY: No. That document is written such 17 that it would be signed off by the Commission. Have I 18 confused - - 19 CHAIRMAN STITT: I think we understand. I mean, 20 we can have a differing opinion and we commonly do. There's 21 lots and lots of information out there. Whether they choose l 22- to assess this in light of other risks is really what 23 they're saying. If they sign off on that, they're not 24 willing to do that. 25 All right. We have an amendment that was seconded 1 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L______-______-_________ _ _:_______ _________________-_____________________________-______________________________________a
71 i 1 for discussion. 7~T Q 2 Jeffrey? 3 DR. WILLIAMSON: Okay. Just a point of 4 clarification. The motion we're currently discussing, then, 5 is the original provision three adopted by the ACMUI in 6 September 1997 with both sentences in place? 7 MR. GRAHAM: In terms of the friendly amendment 8 that you would have to vote on, yes. 9 CHAIRMAN STITT: Other comments? Naomi. 10 DR. ALAZRAKI: I would be in favor of supporting 11 the inclusion of stating that radiation risk should be 12 assessed relative to other risks that we are familiar with, 13 because everything we do in medicine is - - at the core of 14 everything we do is the risk / benefit analysis, and if we
) 15 don't submit radiation to the same radiation / benefit 16 analysis, then we're in a sense-blessing this radiation as 17 something very different from everything else and has.to be, 18 therefore, treated so differently. I mean, we have to bring 19 it down to earth and put it in the context of everything 20 else that we do. So I would say regardless of what the 21 working group that you quoted is doing, that we should come 22 out and say yes.
23 CHAIRMAN STITT: I have a comment, and then Jeff. 24 We're told that the Commissioners are looking for 25 risk- based assessment and they keep discussing that with 1 1 i ANN RILEY & ASSOCIATES, LTD. Court-Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L_____________-
72 1 us, and this is part of the same large pot of discussion. () 2 You assess the risk of radiation medicine, there is a risk 3 to all versions of medicine, and to try to separate them I 4 think is very artificial. 5 Jeffrey, you have a comment, and then I would like 6 to call for a vote. 7 DR. WILLIAMSON: Yes. I think probably it would 8 be better to support the original version of John's proposal 9 and simply leave the second sentence about comparable risk
'10 out of it, because it's, I think, politically pointless to 11 continue beating on this dead horse which the Commission 12 itself has directly rejected. ,
i 13 I think the first sentence, you know, does make j 14 some additional points that are very valuable in our favor. J
) 15 It does reference the issue of voluntary standards a second 16 time in a very important way, and it avoids the fallacy of 17 attempting to distinguish and separate execution of the l
18 medical procedure from the practice of medicine which I i 19 don't think is viable. So I think we've gained something by 20 simply voting for the first sentence of our original 21 proposal and leaving off the politically infeasible
'22 comparable risk sentence. l 23 CHAIRMAN STITT: Cathy Haney has a clarification.
24 MS. HANEY: Let me just say that the Commission
'25 has not directed at this point in this particular area.
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73 1 What Dennis was reading from is a document that would be () 2 used to forward the working group steering alternative to 3 the Commission and, hence, into a Federal Register notice, I 4 'and'if that Federal Register notice was signed or we got a { 5 staff requirements memorandum, that would be the final 6 direction. 7 At this point, the statements Dennis read merely 8 justify that statement and are in there to explain why we 9 did not take the ACMUI recommendation of September as a { 10 working group steering. 11 MS. DURHAM: For clarification, what's on the i 12 table right now is statement number one to remain as is; 1 13 statement number two to remain as is; statement number three 14 to be replaced or to remain the same as the previous policy
) 15 statement? Is that eliminating - - is that also replacing 16 statement four?
17 MS. HANEY: Four is still - - is in there. 18 MS. DURHAM: Okay. I needed that clarification. 19 Thank you. 20 CHAIRMAN STITT: I would like to go to the - - we 21 need to vote on the amendment and then we need to vote on 22 the motion. The only people who can vote are people who are 23 full committee members. 24 Those in favor of the amendment, and the l 25 amendment, just to refresh yourselves, is the ACMUI l b
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74 1 recommendation number three, and it's the last statement, ( '2 . assessment of risks justifying such regulations will 3 reference comparable risk, et cetera. Those in favor of 4 keeping that as part number three, raise their hand. 5 [Show of hands.) 6 CHAIRMAN STITT: Eight in favor? 7 Those opposed? 8 All right. That passes. 9 Now we're going to vote on the motion, and just 10 very briefly, number one - - I'm working from the working 11 steering group alternative - - number one stays as is, 12 number two stays as is, number three is the entirety of 13 number three that the ACMUI previously recommended, and 14 number four is number four. O 15 Those in favor? 16 DR. WILLIAMSON: Was that correct? I thought 17 number two was modified somewhat. No, not in this - - 18 CHAIRMAN STITT: Nc, not in this - - 19 DR. WILLIAMSON: John, I think you did make a 20 modification to two. 21 MR. GRAHAM: No, I highlighted that number two has 22 been modified from what the ACMUI passed since the last , 23 meeting. 24 DR. WILLIAMSON: Okay. [ 25 CHAIRMAN STITT: Those in favor? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 I
75 1 Those opposed?
) 2 MS. HANEY: Can I ask a question? Are we 3 clarifying radioisotopes or radionuclides? I've noticed 4 you've been changing it.
5 CHAIRMAN STITT: We're going with radionuclides. 6 MS. HANEY: Okay. 7 CHAIRMAN STITT: Cathy, anything else? 8 All right. It's time for a break. 9 [ Recess.] 10 CHAIRMAN STITT: Naomi, you've got to be nice to 11 me because I have your official document, that will make you 12 official, an official official, by September. 13 All right. We're moving into training and 14 experience and we are going to start the presentation with a 15 number of formal presentations. We're going to start with 16 Kathy and then she will get into the formal presentation. 17 MS. HANEY: All right. I have put up on the 18 screen a very brief summary of what hours are required for 19 the different type of uses, as well as the different types 20 of users. Where there is a comma, like 35 comma 100, that 21 is supposed to be a period, so - - and the same thing with 22 400, they were just typos, they were done yesterday morning. 23 So just excuse the changes there. 24 But what I'd like to is to go through some of the 1 25 comments that we got from the subcommittees and let you know 1. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
, 76 1 what we have-done with them, if we have addressed them.
2- One of the things that we heard was that rather 3 than talking about didactic training specifically and
- 4 limiting it to classroom hours, as the old rule used to do, 5 use the term structured educational program. This was taken 6 from the current Part 35 for the authorized nuclear 7 pharmacist. So we did adopt that in.the rule already.
8 The question came up is NRC approving an exam or 9 the organization or the certification board? If I step back 10 to say what got us to that question, the philosophical 11 approach to training right now is to require that there be a 12 structured educational program of some number of hours. In 13 some cases there would be practical hours and in some cases 14 there would actually be some case work involved. , 15 Then there would be an exam that was required, and 16 the ruling which right now says exam by an entity approved 17 by NRC. There was a question there about the preceptoring i 18 of the hours. Right now current 35 space, you only have a 1 19 preceptor for practical hours, but the thought would be that I l 20 there would be a preceptor form for the didactic as well as ; 21 the practical, and by signing it the preceptor would be j 22 saying that the individual has competency in this particular 23 area and could function as an authorized user for 100 uses, 24 200, 300, function as an RSO, function as a medical i 25 physicist. So there's a little bit of change there on the l ANN RILEY & ASSOCIATES, LTD. b Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
i 77- -i l 1 preceptor form. ! O V 2 But to go back to the question,.is NRC approving I
- 3. the exam or organization? Right now we.are talking about 4 NRC approving the organization, but if we have time today, 5 you can give us what your recommendations would be. l 6 The last page of the ruled text shows the l
7 appendix, the requirements that we would'be looking at for j 8 someone to be - - an organization to become an approved l l 9 . organization. Again that is probably one of the - -- not as ; i 10- high priority thing right now as the hours are, figuring out 11 what they should be, but we'll spend a little bit of time 12 talking about it if we can. But at least the viewpoint is 13 that we would be approving the organization. 14 There is an issue of seven- year recentness'of' 15 training. The rule says that if you have had'your training 16 within seven years, then - - and it meets these 17 requirements, then you could go ahead and become - - apply 18- to become an authorized whatever. It was discussed at the 19 diagnostic subcommittee and it was tabled to the March 20 meeting, so I will be asking a little bit about that, so if 21 you can think about that during this discussion. 22 One of the things that came up was the 700 hours 23 for the authorized nuclear pharmacist. That was one of the 24 areas where we didn't make any changes between the current 25 rule and the straw man, and Dennis had agreed to maybe look ANN RILEY & ASSOCIATES, LTD. O- Court Reporters ! 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L______________-_____________________--___-__------____------- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
l 78 1 and see if those were the right hours or not. So when we
22 will focus on the training and experience requirements for )
23 lower risk modalities than includes the medical use of l l 24' byproduct materials and diagnostic and therapeutic nuclear 25 material - - nuclear medicine. l I ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 i L (202) 842-0034
94 1 The ACR and ASTRO have followed with interest the () 2 current NRC _e- evaluation of Part 35. We have testified in 3 this regard at the IOM hearings, participated in the NRC's 4 public workshops and maintained a continuous dialogue with 5 NRC throughout this process. While we agree that the 6 revised Part 35 regulation should be risk- informed and can 7 be more specifically related to each modality, the proposed 8 straw man draft by the Part 35 working group appears to have 9 only moved in one direction, that is, to drastically reduce 10 the training and experience requirements for those seeking 11 an alternative pathway to Board certification for the 12 highest risk, most dangerous and experimental procedures. 13 We believe that if the proposal is adopted into 14 the new regulation, serious mishaps with these therapeutic O
\msl 15 doses of ionizing radiation will significantly increase, 16 leading to unnecessary harm to patients and the erosion of 17 public confidence i11oth the NRC and those performing these 18 procedures.
19 The ACR ani AS'i?P maintain that medical Board 20 certification requirements under current 35.940 are 21 essential to the safe practice of the higher risk modalities 22 under Part 35. In addition to basic training in radiation 23 protection and source handling, we believe that the safe ! 24 therapeutic administration of applicator confined L 25 radioactive material requires comprehensive training in the (
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i 95 1 placement of applicators and sources, use of complex () 2 planning tools to accurately deliver treatment and direction 3 of developing a safe treatment delivery program with a 4 qualified medical physicist. 1 5 In short, the ACR and ASTRO firmly hold that to 6 adequately protect the safety of patients for these higher 7 risk procedures, the clinical training that is involved in a 8 three- year ACGME approve training program, and essential ! 9 safety practices, cannot be separated. 10- For a reasonable level of patient safety to be 11 assured for these higher risk modalities, the physician 12 directing treatment must also possess extensive clinical 13 experience in appropriate patient selection, follow- up 14 evaluation of the radiation's effects and, most importantly, 15 the effective management of side effects and/or 16 complications. 17 However, in the event of a radiation emergency, 18 -- moreover, in the event'of a radiation emergency due i 19 equipment failure or operational mishap, we believe that the ' 20 proposed limited requirements would not adequately prepare 21' the authorized user with the skills and knowledge necessary 22 to limit any adverse impact. 23 The available date of the five years of 24 misadministration reporting shows that such reportable 25 events are rare and almost never lead to significant adverse () 1 ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 i (202) 842-0034 l
f - 96 1 consequences for the patient. The three year supervised l ( ')
~-
2- clinical experience requirements incorporated into radiation l 3 oncology residency programs has been a critical factor in 4 . assuring that these events are as close to zero as possible. 5 Substantially relaxing these requirements for the higher 6 risk modalities by eliminating the three year residency L 7 program will almost certainly lead to a significant rise in i 8 the number of and adverse complications resulting from , 9 I misadministration. ) I 10 The higher risk procedures need to be reviewed not 11 only for the efficacy of the procedure itself, but also for
- 12 its acute and long- term effects on normal tissue tolerance 13 and possible carcinogenic effects on sensitive tissues.
14 'Significant radiation doses may be delivered to other
/N ]
\% ,) 15 locations at risk besides the planned target volume, 16 depending upon the source and the method chosen to deliver 17 the radiation. Therapeutic radiation doses must be 18 delivered to precise areas with precise margins. These 19 decisions which impact patient safety and control of the 20 disease be treated require the broad training that is 21 obtained in a three year training program.
22 The current requirements for these modalities 23 ensure that authorized physicians have the appropriate 24 skills to routinely make judgments and that all safety and
-25 technical standards have been met prior to initiation of and
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i j 97 1 during treatment. We believe that these criteria are -(~N 2 imperative to maintain and in order to assure patient and 3 public safety, and the interests of high quality medical are 4 well served.
- 5. Thank you again for this opportunity to address 6 the Advisory Committee. I would welcome any questions after 7 re. Holder has finished his remarks. j l
8 DR. HOLDER: Thank you. I am Larry Holder from 9 Baltimore, and I just have a few comments. I thought I 10 would tell you first that I practice nuclear medicine and 11 diagnostic radiology and have been doing so for about 12 20- plus years, and first was in a large community hospital 13 that was university- affiliated, a moderate sized community 14 hospital, and for the past five years, have been Director of l() 15 Nuclear Medicine at the University of Maryland in full- time 16 academic practice, so I think I have seen a gamut of i 17 situations. 18 I want to say, first of all, that I do agree that radiation in nuclear medicine, as used today, is very safe 4 l 19 20 and we find that there are not any, I believe, significant , t ! 21 risk problems to patients. The question is, is why is that i 22 so? And I think it was touched on by some of the speakers 23 earlier that it is so because the NRC has up to now been 24 concerned about what happens or when what happens is not 25 what was intended. And this does not, to me, indicate l ANN RILEY & ASSOCIATES, LTD. s_/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 ! (202) 842-0034
98 1 prescribing the practice of medicine, it is simply saying () 2 3 that if you'are going to use radioactive materials, that you should use it correctly and that there ought to be some 4 . standards around that are propagated that make sure that 5 that occurs. 6 I would also make one other comment. That just 7 because some areas in the practice of medicine, and in the 8 use of other instruments, are not doing their job, does that 9' mean that the NRC shouldn't do their job? So one of your 10' panel members talked about putting a foot on a fluro pedal 11 doing cardiac catheterization and radiating the hell out of 12 the patient, and nobody watches that. I agree, I think it 13 should be watched. 14 I am head of the Radiation Safety Committee and () 15 the Human Use Subcommittee at the University of Maryland and
- 16. was also at Union Memorial Hospital in Baltimore, and time 17 -and again, because we also look at doses related to the use i
18 of ionizing X- ray machines, the highest doses, every single l 19 time, are by cardiologists, who are badged, because they are I 20 not trained in radiation in that area. And they want to get 21 _an answer for their patient, which is laudable, but where do 22 we draw the line? And if they are being radiation, the 23 patients are being radiated, and who is watching that? i 12-4 And so the.NRC has been doing a job for nuclear ; 1 25- and that is why we have such a good reputation. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D C. 20005 (202) 842-0034 w___-___-_-__- ._ _ _ - _ . _.
99 1 From a practical point of view, I can give you a ( 2 variety of examples of the kinds of things that you need to 3 be around to see, and my issue is, and I don't want to get 4 _in today how many exact hours of training and so forth. I 5 do know that what we have had in the past, which is a very 6 high level, essentially, a residency program or a fellowship 7 training program, has worked. 8 At the other end, I think if you drop down to a 9 week, or whatever it is, you are not going to be able to see 10- things such as - - and when I knew I was coming, I tried to 11 make a list of things that went on this week and last week 12 such that we have pregnant patients, and how do you deal 13 with that. We had a pregnant nurse, a health care worker. 14 We had doses that infiltrated, and what do you with a () 15 butterfly? We had an issue with instrument QC and how do 16 you deal with that. We had a problem of concurrent 17 medication. Somebody was having a gastric emptying study
~
18 and threw up and because they were on an incorrect 19 medication. 20 We had, I got called because they were bringing 21 some - - a generator in, in the evening, and there was a J 22 lot of confusion in the public, because this was - - the security guard was new and a whole series of things. 23 24 The next area that I would like to mention is 25 that, if you give somebody a license to use radioactive O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i i
100 1 materials today, what happens tomorrow and the next day? In 2 the last couple of years, we are using technetium and [} 3 indium, which is a longer- lived tracer, to label white 4 cells for infection. We are now labeling antibodies for 5 tumors. All of these things, in terms of the guidelines, in 6 terms of preparation of. radio- pharmaceuticals and so forth, 7 and the practical aspects, I don't think you can learn in a- ! 8 short time, and that is part of the issue. l 9 And, now, in our shop, we are just beginning to do L 10 a phase two clinical study where we are giving 11 indium- labeled antibody to lymphoma. We are then doing 12 dosimetry and then, depending on what does not go to 13 critical, other critical organs, or other organs, we are l 14 going to label the antibody with itrium for therapy. Now, l l
/~'s !
l(j i 15 how does that fit in with giving somebody a license who is j l 16 not trained and is not primarily practicing an area that has 1 17 potential significance? ' l 18 The last item is, I noticed on No. 4 today, you 19 are talking about working with other organizations to accept l 20 their practice standards and how you decide about who you 21 are goiag to allow to certify and so forth. And I don't 22 want to get into that either, but I will tell you that if l 23 you look at the standards that are out there, they tend to I 24 follow the guidelines that the NRC has suggested, because l 25 people do look at the NRC as an impartial group, and so you
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101 1 1 all have a tremendous amount of stature. So I think that 2 you need to err on the side of taking the high road and (G~~') 3 setting a good example. 4 I don't think I want to say anything else. I have 5 probably said too much. If people have questions later on, 6 I will be glad to answer some of the practical questions 7 which I see you all are asking here. 8 CHAIRMAN STITT: Thank you. Dr. Baskin. 9 DR. BASKIN: Good morning, I am Jack Baskin. I am 10 President of the American Association of Clinical 11 Endocrinologists, and I am a practicing endocrinologist in 12 Orlando, Florida. I thank you for allowing me to speak 13 today. I think it has been at least two decades since an 14 endocrinologist attended one of these meetings and I suppose ( () 15 things have been going pretty well without us. 16 We became somewhat disturbed because of the 17 changes that are being made, and I am sort of down at the { 18 other end of the spectrum from what you have been hearing 19 this morning. I would like to refer my comments to Rule No. 20 35.39, the changes in the licensing for endocrinologists. { 21 A little bit of history, endocrinologists were the 22 first people to ever use radio iodine over 50 years ago. We { J 23 have even using it ever since. We feel that we have an ! 24 astonishingly safe record. We don't know of any reportable 25 misadministration that have occurred among endocrinologists. I l (^\ ANN RILEY & ASSOCIATES, LTD. (_,) Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
102 1 As someone said earlier, if it ain't broke, don't fix it. 2 We are concerned specifically about the changes ( 3 that will require an additional 40 hours of training for our 4 license to use radio iodine. Our only interest is in using 5 radio iodine 131 for the treatment of hyperthyroidism. We 6 feel that this is a definite advantage to our patients not 7 -to have to be referred out to a second level of specialty 8 care, oftentimes to~a different locale at a hospital to be 9 treated. They can be administered a capsule of radio iodine 10 by the endocrinologist to diagnose the disease, who will be 11 following this patient for the rest of their life, and we 12 think the chances of misadministration and so forth are much 13 less when it is done by the endocrinologist. This is the 14 way it has been done.
/~s
( 15 Currently, endocrinologists are -
) -
first, spend 16 three years of internal medicine residency, then they spend 17 two to three years in a fellowship program, during which L 18 time they have extensive training in thyroid 19 patho- physiology. They have extensive experience in 20 treating many times over the 10 patients with 21 hyperthyroidism that are required under the current rule. 22 They then - - this then leads to Board certification in 23 endocrinology. I 24 We feel that this, in conjunction with the 80 hour i 25 program that is currently being offered, which includes ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L__.__________.______.________._____ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ ._ _ _ _ _ _ . _ _ . _ _ _ _ _ _ . . _ _ _ _ . _ _
l 103 1 radiation safety - - radiation protection, instrumentation, i !- 2 is adequate for the use of radio iodine to our patients. l 3 We are concerned about adding an additional 40 4- hours, which is somewhat redundant. We think that the 5- calibration of dose calibrators and so forth, and unpacking 6 radioactive materials be taught during the two week course 7 we now administer, and that to add any additional onerous 8 steps to jump through are not necessary. They are not risk 9- associated, at least that we can see. 10 So we would urge that the current rule concerning 11 the use of radio iodine by endocrinologists be maintained 12 with people who are Board certified not even having to go 13 and treat 10 additional patients after they have finished 14 their two or three fellowship, and then Board certified in () 15 endocrinology. 16 If anyone has any questions, I'll answer them. 17 CHAIRMAN STITT: All right. Thank you to all of 18 the individuals who have made formal presentations. I think 19 -- Kathy and I have discussed opening this up to 20 commentary both to speakers and the public who wish to add a 21 different perspective in questions coming from the ACMUI 22 -- or to our speakers or any commentary you all have to 23 make. 24 Carl is going to speak or is he just - - he is 25 leaving. (~' ANN RILEY & ASSOCIATES, LTD.
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104 1 Dennis. f~} O 2 MR. SWANSON: I guess questions to speakers from 3 ASTRO, ACR, Dr. Holder. For many years, the regulated 4 community has complained that the NRC has intruded into 5- areas of the practice of medicine. The proposed revisions 6 of the regulations are an attempt for the NRC to focus their 7 regulations only on the radiation safety aspects of.the 8 training and experience. I don't -- all of us agree that 9 there needs to be additional training and experience so as 10 to ensure the appropriateness of the medical and clinical 11 aspects of providing this type of patient care. 12 I guess the question that I have of you, are you 13 implying that, in fact, there are not voluntary standards in 14 place to address those additional training experience ()
/"S 15 requirements beyond the radiation safety requirements so as 16 to ensure the appropriate medical and clinical decision 17 making in providing this care? In other words, are there 18 not voluntary standards such as credentialling committees 19 and hospitals that look at this, peer review, the
. :2 0 liabilities, a court system, et cetera, that can provide 21 appropriate assurances of additional medical decision 22 making?
23 If you are saying that these voluntary standards , 24 are not in place, then I think it comes back to our medical l 25 policy statement in that the NRC would have the right to I [~ ANN RILEY & ASSOCIATES, LTD. !
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105 1 regulate those types of issues. Now, before you address
') 2 that question, however, let me give you a different 3 scenario. Who oversees the delivery of chemotherapy to 4 patients, and the appropriate clinical and medical decision 5 with regard to those particular types of agents which 6 present every bit as much as risk to the patient as does J
7 radiation therapy procedures? 8 MR. BLITZER: Let me answer that. The Nuclear 9 Regulatory Commission is not here to regulate other aspects 10 of medicine, it is here to regulate nuclear material, and 11 that is it is charge. And I think it is irrelevant to ask 12 whether or not chemotherapy or a denizen or whatever is 13 administered safely. That is not what we are here to talk 14 about. We could just as well be talking about whether it (""\ () 15 is, the airline industry is adequately regulated. That is
\
16 not what we are here to talk about. 17 There are guidelines in hospitals. But, frankly, i 18 your average hospital staff, your hospital administrator, is l l 19 not in a position that the NRC is to ensure that the l 20 American public is adequately protected. Voluntary 21 guidelines are not adequate. 22 MR. SWANSON: So that we don't want to - - we 23 don't want to make these radical changes that are shown up 24 on the slide for fear that we are going to be exposing a 25 tremendous risk in patients receiving radiation, and that's l
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106 1 the charge of the NRC. (
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2 DR. HOLDER: I'd answer your question, Dr. 3 Swanson, in two ways. One, when I was in the service, one 4 of the commanders used to say that you don't get what you 5 expect, but you get what you inspect. And I put the NRC 6 regulations, whatever they turn out to be, in the area of 7 what we inspect, what we really think needs to be done. 8 Voluntary standards, as I said, follow along basically with 9 the suggestions of the NRC. 10 And the second issue is I notice that in the 11 official paper which you have from the American College of 12 Radiology this letter dated the 27th of February that they 13 make the point about it is possible to reduce some of the 14 hours. And the reason I understand that the suggestion of (~) ( v 15 the ACR committees who looked at this issue was that it was 16 fine to reduce the hours because they were doing just what 17 you said, trying to separate out the safety aspect from the 18 aspects of clinical practice and clinical learning that is 19 at the other extreme. 20 I think Dr. Salazar used that example for 21 radiation oncology, but I think it's the same for nuclear 22 medicine, so that the safety aspects clearly require more 23 time than the immediate revised proposal we saw, but they 24 probably don't need at least in my opinion the same level of 25 500 practical hours. A lot of that is clinical learning, I ANN RILEY & ASSOCIATES, LTD. A)
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107 1 think. So somewhere in between is probably appropriate. 2 MR. BLOOMER: With regard to voluntary standards, 3 I think ten years ago you might have been quite safe to 4 assume that therapeutic uses of radiation byproducts would 5 have been done in a hospital, would have been supervised by 6 various levels of board- directed committees to make sure 7 that it was done safely by appropriately trained 8 individuals. But today, and what we foresee in the 9 foreseeable future, is a tremendous switch of inpatient 10 therapeutic procedures to outpatient procedures. 11 It's very conceivable that gamma knives will be on 12 an outpatient basis in an ambulatory facility and not 13 controlled by a hospital board, not controlled by peer 14 review processes. Prostate brachytherapy will now be done () 15 16 and is being done in ambulatory centers where there is no supervision by disinterested third parties. So I believe i 17 that in the use of radioactive materials there are not 18 adequate voluntary standards out there to protect the public i 19 at large in the manner that they've been comfortable with 20 before. 21 CHAIRMAN STITT: Thank you. There are several 22- Members of the Committee who have comments to make. i 23 Dr. Cerqueira. 24 DR. CERQUEIRA: I'd like to make a couple of 25 comments, both as a practicing cardiologist and as a l ('s ANN RILEY & ASSOCIATES, LTD. (,,) Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 I (202) 842-0034 '
108 1 board- certified nuclear medicine physician. And they 2 (~'} really address I believe it was Dr. James Marks who reading 3 his prepared statement talked about exclusive right and 4 privilege for an NRC license, and I think ultimately what a 5 lot of this does break down to is exclusive right and 6 privilege and not radiation safety, and I think what this 7 Committee has attempted to do is really focus on the aspect 8 of radiation safety and what's required for an understanding 9 of the safe use of radiation rather than all of the other 10 sort of political issues that have sort of been thrown into 11 this. 12 And I think the committee in terms of the work 13 that we've done, we have really attempted to make a focus on 14 what is really required for radiation safety, recognizing n) ( w/ 15 that physicians who are eligible for licenses have basically 16 gone through four years of college, four years of medical 17 school, usually three years of training in internal medicine 18 for cardiologists and then three years of cardiology 19 training. So they have quite a bit of experience on basic 20- biology and a lot of the other safety aspects. t 21 So I think we really have to look at the issue of 22 radiation safety on that particular point. And if we really 23 look at that, if we objectively look at what it takes to 24 educate somebody with that level of training, experience, 25 and education, I think the hours that have been proposed l ANN RILEY & ASSOCIATES, LTD. O) (,, Court Reporters l 1250 I Street, N.W., Suite 300 ' Washington, D.C. 20005 l (202) 842-0034
l 109 1 1 have been found to be reasonable. l (} v 2 I think it's also important to realize, addressing l I 3 strictly the issue of intravascular brachytherapy, which 4 hasn't really been addressed, you know, directly, where 5 cardiologists are doing these procedures in a relatively ; l l 6 emergent situation in many cases. It's in the middle of the 7 night, it's at ungodly hours in many cases when you're going 8 to be doing these procedures, and you really want to do this 9 procedure as safely as possible, but also expediently as 10 possible. 11 The cardiology community is very interested in 12 working with medical physicists who would be available to do 13 all of the issues related to radiation safety. Some of the 14 dosimetry community would also be very much important to get (G) 15 involved in this, because we're dealing with a limited 16 number of radioisotopes that would be used in this 17 situation, and we're dealing with really radiation doses 18 that are easier to calculate, since you are using a limited 19 number of either strontium or possibly even the iridium wire l 20 which does require more work. But I think the cardiologist 21 working in conjunction with the medical physicist could 22 basically do all of this in a safe manner, both in terms of 23 the patient, the staff, and as well as further downstream 24 risks to the patient. So I think the hours that were 25 proposed by the American College of Cardiology given the l (~h ANN RILEY & ASSOCIATES, LTD.
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110 1 limited organ use that the cardiologist would be engaged in 2 are reasonable.
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3 Similarly for diagnostic studies, I can tell you 4 that when I trained as a cardiologist I had as much, in many I i 5 cases more radiation training than I did when I spent time 6 as a nuclear medicine resident in terms of the basic aspects 7 of radiation safety. That may have been a quirk of the 8 program or the fact that I already performed cardiology, but 9 I think cardiologists are trained appropriately. The ACGME 10 guidelines that are being revised include specific 11 information, the guidelines that have been proposed by the 12 American College of Cardiology also deal with these issues. 13 CHAIRMAN STITT: Thank you. 14 Dan? () 15 16 DR. FLYNN: Yes. I have a few comments. i First of all, the training, I've just finished 17 seven years on the Residency Review Committee, and the
-18 training has been increased from three years to four years, 19 so I heard a number of times it being mentioned it was three 20 years long. And I think the Committee should really 21 understand that in the course of that training, besides the 22 clinical, the radiation biology, and the radiation physics, 23 these residents are being examined by their institution 24 every year, in addition to an external exam by the American 25 College of Radiology every year, in addition to the board i
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111 1 exam process. l 2 Now after they have all this training in radiation 3 oncology, they take a written exam, of which 20 percent will 4 fail the written exam, and for the 30 percent vdio pass the 5 written exam, go on to take the oral exam, approximately 60 6 percent to 70 percent will pass, and another 30 percent will 7 fail. And it doesn't mean that the candidates were poorly 8 trained, it means that the standard is'very tough. The 9 standard is very high. Those that fail the exam then go on 10 to take the exam if they conditioned one section, examined 11 in that section, or the entire exam over again until they 12 pass the exam. So I think the standard is very high, and I 13 think the NRC proposal will certainly lessen the standard. 14 In terms of tbc rat;egories up there, in case those Ii V 15 of you don't know, the ;- 570 is for dilution and uptake 16 studies, and 35- 200 is imaging. So the first two are 17 nuclear medicine primarily. The 35- 300 is the unsealed 18 therapy, so that could be nuclear medicine or radiation 19 oncology traditionally; 35- 400 is brachytherapy; and 20 35- 600 is the teletherapy, cobalt, for example. On the l 21 35- 300 I've seen an official document for the American 22 College of Radiology and the American College of Radiology ; 1 23 being primarily an organization of diagnostic radiologists ' 24 in terms of the numbers of physicians who are a member of
-25 the American College of Radiology.
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i 112 j l' 1 But even the American College of Radiology noted
- 2 that, and I won't say whether I agree with them or not, but 3 their position was that both nuclear medicine physicians and 4 radiation oncology physicians are both qualified to deliver 5 such things as strontium treatment for bone metastasis, not 6 diagnostic radiologists.
7 Yet there are some hospitals that are hospitals 8 that are trying to add on diagnostic radiologists to that 9 license where if you talk to the diagnostic radiologist, 10 number 1, they haven't had the training of injecting 11 patients for. therapy with unsealed sources. So that's very 12 risky. You see, unlike iodine- 131, you have patients that 13 could have-fatal complications because of bone marrow 14 suppression. This is a cancer treatment. () 15 And the American College of Radiology goes on to 4 16 state in the last two sentences of that section is that 17 these patients need to be followed, which means that their 18 blood counts need to be followed. Who's going to make sure 19 their blood counts are followed in a potentially lethal 20 treatment? 21 And 35- 400 in terms of brachytherapy, I think we 22 have some good examples right now in terms of experience and 23 training. Strontium- 90 ophthalmic applicators, that's a 24 brachytherapy source. We have thousands of patients out 25 there right now who've been overradiated because the sources f O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
t l 113 j l 1 either weren't calibrated correctly or because the decay l 1
)
2 calculation was incorrectly done because there wasn't a 3 physicist to know what' half- life meant. 1 4 So I think if you then go on to take brachytherapy l 5 in terms of the cardiology, here's where I disagree with my 6 cardiologist friend, because I have a letter here from the 7 American College of Radiology which hasn't been read, but in 8 the letter from the president of the American College of 9 Radiology on February 17, he says that cardiologists have 10 extensive training and experience in the risks and safe use 11 of radiation. And I dont think that's an accurate , 12 statement, because when you say extensive training and l 13 experience, you imply in comparison to other people like 14 radiation oncologists and nuclear medicine physicians, which 15 is not true. G("N 16 And on the last part of the letter it states that 17 the American College of Cardiology recommends that ancillary 18 personnel may include radiation safety officer, and then 19 down -- specific recommendations that the cardiologist would 20 have 30 hours of training in radiation safety, biology, and 21 physics. Thirty hours of training in terms of a 22- brachytherapy procedure in comparison to four years of 23 training plus a very tough American Board of Radiology exam 24 process to get through, which takes over a year even if you 1 25 pass. ! I
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f L ' l 114 l 1 But, for example, using the radiation safety I) v 2 officer, no disrespect to radiation safety officer, but I
~3 think NRC revisited this before when for the HDR accidents 4 where-initially they put radiation safety officer with the 5 radiation oncologist being physically present. Then they 6 removed that and put the medical radiation physicist, 7 because the radiation safety officer with all due respect in 8 many institutions doesn't know how to use the high dose rate 9 remote afterloader, and probably won't be familiar with the 10 devices and doesn't have the time to be familiar with all 11 the devices in terms of intravascular therapy. Part of it l
12 is physics and biology, so I can see where you need to have 13 the physicist there, but part of it's clinical. 14 For example, what happens if these patients have
!D
( ,/ 15 had previous radiation for thyroid, lung cancer, or Hodgkins 16 disease? Who's going to take that into account? What if 17 these patients have a collagen vascular disease? What if 18 these patients have other medical conditions that might 19 cause the prescribing authorized user to change the dose or 20 not give the treatment at all or at least enter into a 21 discussion with the patient that if you have scleroderma or 22 systemic -- or lupus, you may be taking an additional risk, 23 which the patient should be aware of before they have an 24 intravascular therapy with a therapeutic source. 25 So I think we've found with HDR that when you have ANN RILEY & ASSOCIATES, LTD. [~)#
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115 1 the radiation oncologist physically present, the physicist , () 2 physically present, that the physician handles the patient (.) 3 but the medical physicist handles the device and the safety 4 aspects in terms of getting the source into the shielded 5 condition. And there's been incidents with intravascular 6 brachytherapy which I think have worked out well because the 7 radiation oncologist was there, the physicist was there, and 8 the cardiologist was there. 9 I don't think that radiation oncology physicians 10 should be trained to tickle the coronary arteries to cause 11 arrhythmias. I don't think we should be doing the 12 cardiologist's job. But I think for prostate seed implants 13 it's a team approach nationwide. The radiation oncologist 14 is there, the urologist is there, there's no turf battle. A t,v) 15 There was a couple of instances where the urologists did it 16 themselves, and the patient had extremely bad consequences 17 because the urologist did it alone. So I think the team 18 appron.n has worked really well in other areas, and I think 1 19 it should work well in this area also. ' 20 CHAIRMAN STITT: Dr. Alazraki? 21 DR. ALAZRAKI: Dr. Wilson, you've been waiting. 22 CHAIRMAN STITT: Okay. Dr. Wilson, go ahead. 23 DR. WILSON: I would just like to come back to the 24 original question asked by Mr. Swanson and respond to it. I 25 As alluded to by Dr. Flynn, I think we should l (~'); ANN RILEY & ASSOCIATES, LTD. s_s Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 ( (202) 842-0034
116 1 recall that the American Board of Radiology exercises very [ 2 rigorous control over the training and testing which is 3 required to demonstrate minimum competence in the practice 4 of radiology, radiation oncology, and medical physics, which 5 is agreed upon by the profession as principally responsible 6 for the use of ionizing radiation in medicine. And once we 7 begin to discuss anything less than the requirements of the 8 American Board of Radiology, we're beginning to discuss
.9 criteria for evaluating education, training, and performance 10 which are at a level below minimum competence.
11 I think that what has been proposed is unwise, 12 because it risks the NRC undermining the entire 13 certification process now extant, and by establishing its 14 own certification process -- I remarked on this in my () 15 prepared statement, but I just wanted to come back to it and 16 reinforce it -- because the certification process currently 17 evaluates education, training, and performance at a level of i 18 minimum competence, and anything less than that would be 19 incompetence. 20 CHAIRMAN STITT: Naomi, did you have a comment you 21 wanted to make? 22 DR. ALAZRAKI: Yes. Obviously NRC is going to be 23 bombarded with letters from various groups advocating a l 24 number of different positions from keep it as it is, it 25 ain't broke, don't fix it, to risk- based performance
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1 117 l 1 regulation would demand that certainly in the diagnostic ('] 2 area perhaps there's room for some decrease in the training
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3 and experience requirements. ! 4 But even in that area you're going to see a number 5 of different viewpoints. Dr. Holder expressed on behalf of 6 the American College of Radiology something in between what 7 was existing and what's up on the board there. And I think 1 8 from my perspective that's fairly reasonable. 9 I do think that the drastic reduction that was h 10 proposed as a straw man here, to go from 1,200 hours to 120 11 hours overnight, doesn't make much sense to me as an I 12 individual, not to mention general public, and I think if 13 there is any reduction that these have to be graduated and ) 14 tested and verified that safety has not been compromised. (a) 15 Even in the diagnostic area, although you're 16 dealing with low doses per individual patient on hand, you 17 can have curies of activity. You have a couple of 18 technetium generators, you've got more than two curies of 19 activity in your lab. So the potential for accidents which 20 are not innocuous is real, and should not be forgotten in 21 terms of the training and experience requirement. 22 Also, although NRC is attempting to regulate 23 radiation safety and as much as possible remove it from 24 practice of medicine, as you can see from the discussions 25 that we have over and over again, in some ways that's not
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118 1 entirely possible, in some ways. And so I guess I'm
~h speaking toward the diversity of opinions that we're going (d 2 3 to get and that NRC, I would.think ACMUI should moderate in 4 terms of advice of doing anything very drastic, j 5 CHAIRMAN STITT: We'll go to Dr. Marks, who is at i
6 the microphone and then Jeff and then John, and I'll also j 7 throw in here that if at all possible, as in all of our l l 8 meetings we are directed to try to come up with a consensus. 9 This is hours and hours and hours of work that 1 10 many people have been through. We have seen it at the 11 advisory committee many, many times and it may be difficult
. 12 to come up with a consensus because there are so many 13 specific points but we should at least keep that in mind.
14 DR. MARKS: As you said, radiation safety is so () 15 tied to clinical practice, I agree, it's inseparable. 16 I want to dissect a perception issue that you, the 17 committee, has to deal with -- is this just a turf battle, a 18 political battle or is this really about a patient's safety. 19 If you take away all of the brachytherapy that we 20 do, it won't hurt us economically. It can't be more than 5 21 percent of our practices and it is a lot of work and 22 actually there's very few of us in the entire radiation 23 oncology community that is really qualified to do 24 brachytherapy, so I don't really perceive it as a turf issue 25 or as a political issue.
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119 1 I perceive it as an educational and patient safety 2 issue. 3 You take away the American Board of Radiology as 4 the certifying agency for physicians that have been properly 5 trained and at the same time you take away ACGME accredited 6 training, I can't imagine that you are going to have 7 anything good come out of it.
- 8 I thoroughly agree with Dr. Flynn. What we have 9 done in the past, the team approach, has worked very well.
10 We can collaborate with those of you in cardiology very 11 nicely. There are a few of you like yourself that are 12 highly trained and even certified by one of the radiological 13 specialties but there are very few of you. 14 I think if you look at the vast range of () 15 cardiologists doing invasive work, they really are not so 16 inclined to go back and get that additional training. It is 17 just more practical for us to integrate it with you and work 18 with you as we have done in the other specialties. 19 I think it has worked well and can continue 20 working well. 21 CHAIRMAN STITT: Thank you. Dr. Williamson. l 22 DR. WILLIAMSON: Thank you. I guess I have l l 23 complained as much as anybody about how intrusive NRC l l 24 regulation of our community can be and indeed I find many L 25 aspects of the sort of enforcement policies sometimes make (9 ANN RILEY & ASSOCIATES, LTD. b_/ Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l (202) 842-0034
120 , 1 it more difficult rather than easier to practice good 2 _ quality radiation method -- medicine -- but I do think that 3 regulation of radiation medicine can play a very key and j i 4 positive role and to some extent has. 5 I think the most helpful thing to public and 6 patient safety that can be done is to try and bring that 10 7 percent of radiation medicine providers that remain outside 8 the bounds of acceptable practice standards back into the 9 fold and focus most of the resources on that instead of 10 nit- picking the rest of the people to death who do have 11 good quality practices. 12 I think performance- based regulations is, you 13 know, an ideal approach for doing this. I think some of the 14 ways of setting up such a system are sort of to define some
.Q I) 15 basic rules and endpoints that have to be followed, and I 16 think one of the single most important things I think to be 17 done is to define and articulate what are the qualified 18 personnel to carry out these various procedures.
19 I think in the area of radiation oncology 20 procedures that I do that would be the physician, the 21 radiation oncology physician, the physicist, dosimetrist and 22 in some cases other ancillary personnel, and in my 23 experience it's the most important factor in maintaining a 1 24 safe and quality operation. 25 So'I guess the question is how does that bear on I l l l
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121 1 this issue, having given that introduction. I guess it sort 2 of scares me to think about urologists doing prostate ]
-3 implants without a radiation oncologist present. It 4 frightens me to think of a gynecologic oncologist doing high !
1 5 dose rate brachytherapy treatments for definitive treatment 6 of carcinoma of the cervix without a radiation oncologist. 7 I remember one experience from my own career as a ; i 8 physicist, clinical physicist, doing eye plaque therapy for , 9 intraocular melanoma with an ophthalmologist. The plaques I 10 are fabricated in advance and sized to what we think the I 11 tumor will be based on the available imaging studies and in 12 this case when the eye was mobilized it turned out that the 13 tumor was two or three millimeters larger in diameter than 14 what we had planned. The ophthalmologist was insisting on ) () 15 16 putting that plaque in. i Now I wasn't being listened to but only because 17 the radiation oncologist was there and able to intervene, 18 and almost force the procedure to be determined so a new 19 plaque could be fabricated was the scenario of a patient 20 being deprived of their opportunity for local control but 21 subject to the full spectrum of complications that this 22 procedure entails was that avoided. 23 So I am concerned. I think placing sources in the 24 correct place is a surgical skill that requires an awful lot 25 of clinical experience. I think in the more advanced g ANN RILEY & ASSOCIATES, LTD. ("'/ g Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 L__________________._. _ . _ _ _ . . . - _ _ . - - - . - -
122 I 1 brachytherapy techniques that are image- based such as i 2 prostate implants there is'a significant and very l 3 sophisticated interaction between the radiation oncologist, ; I 4 the physicist, the treatment planning, whereby the sources 5 may be. repositioned and I think this was very eloquently 6 described by Dr. Marks. i
.7 I think there are other issues. I would be ;
i 8 concluded about inappropriate patient selection and members l 1 9 of the public being irradiated for inappropriate clinical I 10 indications, and while I agree, I don't think, you know, NRC 11 should get involved in the issues, detailed issues of how I 12 patients are selected. l 13 I I-think it one of the best performance- based i 14 things they could do to make sure that the people doing this () 15 16
'at least have training which is considered essential by 1
current standard practices, so I myself would urge the j 1 17 committee to look really hard at whether we want to relax ! l 18 the training and experience requirements for brachytherapy l 19 . types of procedures and teletherapy to the extent proposed 20 in these regulations. 21 CHAIRMAN STITT: Jeff, I am going to use your ; i 22 comments to make a specific -- to phrase a specific question l 23 to the ACMUI and then John will have the floor. : 1 l 24 My question would be if we as an advisory 1 25 committee are going to be trying to put together something i l ANN RILEY & ASSOCIATES, LTD. O- 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034 1
123 l 1 that might address a consensus opinion, think through do you i ' () y 2- want to be dealing with all of these 35 subsections. I 3 Jeff specifically referred to brachytherapy and 4 teletherapy, 35.4 and 35.6 -- we could focus, we could do 5 whatever we want. 6 The NRC Staff would find it valuable if we can 7 come'to some version of a consensus on at least something 8 that we might find pretty important to us. If all we come 9 up with is a lot of dialogue that is on the record, well, 10 then they have something to read. 11 I am going to go ahead with John. 12 MR. GRAHAM: I think that to shape a discussion of 13 your question, and where I am a bit confused as I sit here, 14 this committee in the past several years that I have
) 15 participated with it, spent a great deal of time talking 16 about a medical policy statement to attempt to give guidance {
17 to the Nuclear Regulatory Commission so that we can have the 18 appropriate regulation of radionuclides as required by 19 Federal law, and yet to have minimization of the 20 interference of the practice of medicine, which as a lay 21 hospital administrator is continuously defined to me as both 22 an art and a science, where there are individual, very 23 specific decisions being made about a patient by a 24 professional who by definition has assumed the 25 responsibility for integrating his knowledge base with that N. ANN RILEY & ASSOCIATES, LTD. s Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 e___-_____-_-___ - - _ _ - _ - _ _ _ __ _. -
124 1 1 patient's needs, q 2 We passed a reiteration of a policy statement this 3 morning that said that the NRC will continue to regulate the 4 use of radionuclides, the NRC will not intrude into medical 5 judgments affecting patients except as necessary to provide 6 for the radiation safety of workers and the general public. 7 We reiterated a desire that the NRC will regulate 8 the radiation safety of patients only where justified by the i 9 risk to the patients and only where voluntary standards or 10 compliance with these standards are inadequate. 11 Where I am fundamentally confused is having 12 listened to Dr. Blitzer, Dr. Bloomer, Dr. Salazar, Dr. 13 Marks, Dr. Wilson and in particular I need to call -- I i 14 would request clarification of a specific comment that Dr. 1 i.( ) 15 Bloomer made that voluntary standards are inadequate, and 16 that is why the NRC had to stay in this regulation deeply. 17 Having worked with a committee that established a I 18 medical policy statement that said that the NRC will ; l 19 regulate the safety of patients where justified, as a i 20 layperson I was becoming comfortable with the concept that l-21 there are aspects of teletherapy covered by 35- 600 and 22 brachytherapy covered by 35- 400 in which it is imposs.. e 23 to separate the safety of the patient, the safety of the 24 workers, the safety of the public from that form of therapy, 25 and that as a voluntary standard the board certification ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L----------_------------------------ -- - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
i 125 1 process, the residency training that would go witii radiation l j (")'g 2 oncology might be a reasonable approach to regulate that i' N 3 form of care. 4 Now where I am having difficulty is I am hearing 5 that wrapped up in a discussion that says that there are 6 some very specific board certification requirements and 7 extensive residency training requirements that would 8 continue to govern all aspects of 35- 100 for uptake 9 studies, 35- 200 for diagnostic imaging where I have spent 10 years listening to people tell me_that if you dump this 11 stuff down the sink it won't mean anything in the vast 12 majority of cases. 13 So I would like someone to clarify where I thought 14 we were building a model where I might comfortably go along '( 15 with the fact that, yes, there is a clear need for going 16 through a four year residency training program, being board. 17 certified as a radiation oncologist, because the very nature 18 of the risk associated with the form of therapeutic 19 radiology that is being performed is such that I can't 20 separate the patient from the general public, but on the 21 other end of the spectrum that there were things that have 22 probably been over- regulated for the past 20 years. 23 CHAIRMAN STITT: Dr. Bloomer? 24 MR. BLOOMER: Well, I think you're right. I think 25 it would be important for the NRC to separate out the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 { l
126 1 diagnostic and therapeutic aspects of regulation of j/~N[ 2- radiation byproducts and I will defer to other people to 3 talk about 35- 100 and 35- 200 but I am here to basically 4 present to you what we think are the very high risks 5 associated with therapeutic procedures and why the current 6 standards should be left in place. 7 I would just like to reiterate the fact that
-8 prostate brachytherapy is now done in ambulatory. centers.
9 There are free- standing gamma knives in this country that 10 would be unregulated if it were not for the NRC. 11 CHAIRMAN STITT: Dan? 12 DR. FLYNN: Yes, I would like to make a comment 13 for John. 14 In paragraph 2, the NRC will not intrude into () 15 medical judgments, that assumes that the person making the 16 judgment has the medical training experience because I 17 think, you know, that is the assumption that is underneath 18 this. 19 Are we talking about NRC allowing non- physicians 20 to do this work? I mean how much do you cut out in terms of 21 what the experience and training should be? ; 22 I think that 35- 100 and 35- 200, the diagnostic 23 codes, are more like flying a Piper cub and parts of 300, 24 maybe not the iodine but certainly the bone marrow suppressing isotopes 400 and 600, it's like flying a B- 1 25 ANN RILEY & ASSOCIATES, LTD. h(~N Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
127 1 bomber and I don't think after 30 hours of training you can 2 go from flying the Piper cub to the B- 1 bomber. That is my 3 opinion -- especially if it is carrying a nuclear weapon. 4 [ Laughter.] 5 DR. FLYNN: So I think that is where it comes in. 6 I think we feel comfortable with the NRC not intruding into 7 medical judgments if the people who are making the medical 8- judgments have the' training and experience to have the 9 medical judgment.
- 10. The NRC certainly -- I'm sure the NRC will 11 agree -- the NRC does not have anyone on their staff to 12 second guess someone who has had, in terms of clinical 13 judgment, four years of training, who have gone through a 14 one year process after the four years of training, a one
() 15 16 year process to become board certified, of which the failure rate is high. i 17 This is not a rubber stamp kind of exam. Nearly
- 18 half the people who take the exam the first time through 19 don't make it, and thet is not just in reaction to the NRC.
20 This has been something that the failure rate has been high 21 'for some time because the standard is so high. 22 CHAIRMAN STITT: I ignored you, Go ahead. 23 MR. ZOON: I just want to make an observation, and 24 not being a medical doctor myself, and there seems to be a 25 tremendous amount of confusion about what this training and l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
128 1 experience provision in the regulation means. The implication I am hearing is somehow this is viewed as a 2 3- defining qualification for those in these professions to 4 actually practice their profession. 5 I think if that is the interpretation, we have got 6 to ask the NRC to go back to the drawing board on this and 7 completely redefine this. 8 We all agree that each of these professions need I 9 to be qualified by training and experience to practice their ! 10 profession, but if we are looking to an NRC regulation to 11 define that in some way then we are totally misinterpreting 12 this. 13 CHAIRMAN STITT: Cathy, do you want to make a 14 comment? O ( ,) 15 MS. HANEY: Yes. I can just say that the reason 16 for the reduction was to focus only on radiation safety and 17 not to address clinical competency at all. 18 The recognition is that clinical competency will 19 be assessed by someone other than NRC. This is just saying 20 that these individuals are qualified from a radiation safety 21 standpoint to handle the material. 22 MR. ZOON: Well, that's what I am picking up, but 23 I think that this doesn't, obviously from the controversy 24 here, this does not do it in its present form. 25 CHAIRMAN STITT: . Ruth and then Bill. 1. ANN RILEY & ASSOCIATES, LTD. OA Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 '
129 1 MS. McBURNEY: From the comments we heard this
/') 2 morning, this was one of the problems I had on the medical V
3 policy statement of adding in that you would compare it to 4 other risks and other modalities, because the NRC just 5 cannot do that when you are talking especially on this on l 6 the training for authorized users. 7 I was also going to make a comment similar to what 8 Bob was saying, that this particular training is only in the 9 area of radiation safety, on people being qualified to 10 handle that type of material in a safe manner. 11 CHAIRMAN STITT: Bill, go ahead. 12 DR. NELP: I would like to ask our guests, I am 13 not sure what scenario you think is going to develop out 14 there if the regulations change, because as I read the (3 y,j 15 regulations under 35- 4 it says that the physician will be 16 certified by a specialty board whose certification process 17 includes all of these requirements and whose certification 18 has been approved by the Commission. 19 It is very obvious from the discussions that have 20 gone on here the Commission will say what physicians can be 21 approved -- what physicians and training and what 22 certification can be approved, and they are going to approve 23 the certification requirements that are equivalent to or are 24 those in radiation oncology and so forth. 25 That is what I hear being said. For some reason 1 O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034
130 1 you think there is another scenario where people without 2 those medical qualifications are going to be certifiable.
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3 MR. BLITZER: Well, the rules and regulations as 4 they exist right now require three years of training. 5 Those three years are taken out and substituted is 6 the three months of training plus this nebulous statement 7 about some board or, you know, implying that maybe the 8 cardiologists would be approved to give a certification for 9 somebody to minister therapeutic radiology, and that is 10 precisely the problem. 11 The three years are necessary and we believe that 12 the American Board of Radiology is the only group that has 13 got a track record in certifying people to deliver 14 therapeutic radiology. O( f 15 Now if the cardiologist can come along and develop 16 people who have had years of experience, then at some point 17 in the future perhaps the cardiologists could be approved 18 but right now the American Board of Radiology is recognized 19 as having a unique position and (a) we think that should 20 stay, and (b) we think that there must be three years, not 21 three months -- and that is clearly a change. 22 I mean even if you want to ignore this question 23 about whether there should be a unique position for the 24 American Board of Radiology, there certainly shouldn't be a 25 change from three years to three months. l [ ANN RILEY & ASSOCIATES, LTD. \_ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 I I
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l 131 l l 1: DR. NELP: Could you amplify for me what other i l 2 scenarios you are concerned with? The cardiologists will be [ j 3 using intravascular sources. Do you see something -- k 4 MR. BLITZER: Oh, sure. The urologists -- you 5 know, we know of circumstances where urologists have put in 6 seeds, radioactive seeds, in patients. This gives a 7 tremendous dose of radiation. We are talking about on the 8 order of 100 gray -- 10,000 rads -- and for people who have 9 no experience to be administering this, that is what is 10 going to happen under these regulations. 11 DR. NELP: Any other areas of practice? 12 MR. BLITZER: The neurosurgeon are interested in 13 using gamma knives, and again we work closely with the 14 neurosurgeon in my community and in doing stereotactic '(O j 15 radiation have a good program developed, but to conceive of 16 a neurosurgeon who has not had years of experience in dose 17 fractionation -- how does the effect on normal brain vary by 18 the volume of normal brain, by the size of the fractions -- l 19 these are aspects that right now the neurosurgeon have no 20 training in and to say that a group of neurosurgeon should 21 somehow be approved af ter this nany hours, after three 22 months of training, that then a neurosurgeon can certify 23 that people are adequately trained, that to me is crazy. 24 DR. NELP: Thank you very much, 25 CHAIRMAN STITT: Cathy Haney has comments to make,
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l 132 1 and then I need to remind'the committee that it'is a quarter ( ) 2 of 12:00. We still have things on our morning agenda we 3 have not discussed, so if you have any intention of trying 4 to look at a consensus.on any of these points, get ready to 5 bring them up. 6 MS. HANEY: I would just like to clarify that 7 first statement that Dr. Nelp was saying about the approved 8 boards, when we would be approving a board, we would be 1 9 looking to see that in order to sit for that board 10 certification that the elements in Section B, the 11 training -- the structured educational program and the 12 number of cases -- were there. I 13 We would not be looking at anything that had to do 14 with clinical competency or how long the program was or () 15 anything else like that. 16 The reason we left that in there was to give 17 licensees an easy way of getting authorized users onto the 1 18 licenses without having to go through a license amendment ' 19 and without having licensees sitting there and looking at 20 preceptor forms and saying my gosh, it says 39 hours -- is ; l 21 'there a difference between 39 and 41 hours, or if the I 22 authorized user could -- the potential authorized user just 23 looks and says, see, I am approved by this organization and ! 24 I am on NRC's approved list, then an amendment would not be i 25 needed, so again we would not be looking at anything that ' I ANN RILEY & ASSOCIATES, LTD. Os Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
l 133 i l 1 would have to do with clinical experience at all. i I l (~'} 2 DR. NELP: I understand. Thank you. ! (s/ l l 3 MS. HANEY: Okay. 4 CHAIRMAN STITT: Dr. Cerqueira? l ! 5 DR. CERQUEIRA: Cathy, I would like to get a ! 6 clarification just in terms the intervascular brachytherapy, 7 because in reality we are talking about an evolving and 8 emerging technology. 9 We don't know whether it is going to be Strontium, 10 whether it is going to be Iridium. I doubt that it is going 11 to be Phosphorus- 32. i 12 Cathy, would this be covered under either the 400 I 1 13 or the 600 series or would intravascular brachytherapy be {
.14 covered under sort of emerging technologies? Because we
() 15 don't have really enough information at this point as to 16 which of the different modalities is going to be -- 17 MS. HANEY: If this rule were in effect right 18 now -- let's just for the sake of discussion say that the 19 hours were as they are up there -- and we are where we are 20 right now with intravascular, you would be considered an 21 emerging technology and we would be discussing it at the 22 ACMUI meeting saying this is an emerging technology -- they 23 believe "x" -- do you agree? 24 Now let's say it is June of 1999. The rule goes 25 into effect somewhere around October of 1999 and now you
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134 1 have had two years of experience. '(} w./ 2 I would tend to think you would probably be 3 falling into the 35- 400 type of uses and we would be 4 looking for you to have the 200 hours didactic, 500 5 practical, 25 cases, so you are presenting a very 6 interesting thing right now because it is something that we 7 are dealing with and actually was part of the agenda. 8 We are anticipating requests for what should be 9 the training in 1998 for someone doing intravascular so part 10 of the question is ACMUI, what should we be looking for for 11 these cardiologists, and can they get listed as an 12 authorized user on a licenses, but whatever you answer here, 13 I think it has to be consistent with what is going to happen 14 in June of 1999. (A) w .' 15 DR. CERQUEIRA: And again I would really like to 16 make the case that if anything we'd really go much more into 17 the 35- 300 series because we are sort of a limited organ 18 use of application, and again in sort of clarification of 19 the letter, you know, we're talking about cardiologists 20 working with medical physicists who would be doing the dose 21 calibrations and calculations and dosimetry people and 22 radiation safety officer. 23 We are not talking about the cardiologists being 24 solely responsible for all aspects of these program. 25 Getting back to some of the points that Dr. Holder
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135 i 1 made, all of this -- for the first time there is going to be I( l 2 a requirement that people not only have had this experience l 3 but they show some competency in mastering the radiation l l 4 safety aspect, which is something that hasn't been present l l 5 before. 6 There were hourly requirements but there was no 7 real verification that those hours really translated into 8 knowledge about the field. 9 The amount of radiation safety that's covered in 10 the nuclear medicine boards, and I think even the radiology 11 boards, is probably, you know, small in comparison to the 1 l 12 type of experience that people have had. l 13 CHAIRMAN STITT: Jeff? 14 DR. WILLIAMSON: Well, I think that, you know, () 15 intervascular brachytherapy does pose an important question. 16 I would suggest to this committee that we not determine the 17 answer for conventional existent brachytherapy procedures 18 based upon what we think might happen with intervascular 19 brachytherapy. I think the radiation oncology community is 20 certainly going to have to justify its value to these l 21 procedures to be able to say we need a three- year residency 22 for putting the iso stint in, for example. So I think we [ 23 don't know what information will show us in two years, or i 1 24 what kind of a paradigm we will have for the involvement of 25 the different subspecialties. So I think we should sort of ANN RILEY & ASSOCIATES, LTD.
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-1: take a vote on 35.6 and .4 on how it is practiced today. .['g 2 CHAIRMAN STITT: These are clearly related and, in L.)
3 fact, on our agenda we have to' discuss the emerging 4' technologies specifically relating to intervascular.. I 5 agree with your comments, Jeff. 6 Is this committee willing to try to - - as you 7 know, the Staff likes to see something. If we do - - 'if we 8 are able to reach consensus.on the various. things that we 9 have talked about over the years, the fact that we can't 10 reach consensus is also helpful to them. .Can we make any 11 comments regarding 35.4 and 35.6? Jeff is waving his pen. 12 DR. WILLIAMSON: Why don't we discuss the motion. 13' I'll put the motion on the table that for 35.4 and 35.6, 14 brachytherapy and medical devices - - I guess, is what what () 15 16 it is? - - that we should retain as.the alternative pathway for training and experience the three- year accredited 17 residency experience. 18 CHAIRMAN STITT: Is there a second? 19 DR. FLYNN: I'm trying to understand. 20 CHAIRMAN STITT: Do we have a second before we 21 - - all right. .Second? Go ahead, Dan. 22 MR. GRAHAM: Second. L 23 CHAIRMAN STITT: All right. 24 DR. FLYNN: Jeff, you said as an alternate 25 pathway? ANN RILEY & ASSOCIATES, LTD. C Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L_ __ _ -_ _ _ _ _ _ _ _ _ _ - _ - _ - - - . _ _ - - . - _ - - - - - _ -
l 137 1 DR. WILLIAMSON: Yes. 2 DR. FLYNN: And that the number of hours listed 3 here for training, you feel is adequate? If you don't -- 4 DR. WILLIAMSON: Well, I think if focused 5 specifically on the sort of technical safety things, it 6 would be not unreasonable. But I guess what I am suggesting h 7 is that that 700 hours for brachytherapy and teletherapy 8 ought to be embedded in - - 9 CHAIRMAN STITT: Jeff, there already is an 10 alternate pathway. It stays on the books. So you're just 11 -- that motion is the way it is. 1 12 DR. WILLIAMSON: Alternative to board i 13 certification is what I mean. 14 CHAIRMAN STITT: I don't understand.
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() 15 16 sorry. DR. WILLIAMSON: All right, I'll try again. I'm i 17 I'm suggesting instead of proposing 200 and 500 18 hours of classroom training and supervised - - what is it, 19 supervised work experience focusing solely on radiation 20 safety, that we retain the current requirement which is a 21 three- year clinical training experience in an accredited 22 program. 23 CHAIRMAN STITT: You are saying maintain status l 24 quo? 25 DR. WILLIAMSON: Basically. ANN RILEY & ASSOCIATES, LTD. O 1 Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
138 1 CHAIRMAN STITT: The current regulatory status 2 quo? All right. The committee - - ~that's how I understood l 3 the motion. That's what you said to me, John. j 4; Okay, let's discuss that. Dennis? 5 MR, SWANSON: I would tend to' agree with that, and 6 this is the reason why. We have commented several times l 7 tha't we need to develop a medical policy statement, and that 8 our regulations will flow from our medical policy statement. 9 If you look at the medical policy statement that we agreed 10 on earlier today, it says the NRC will regulate the 11 radiation safety of patients only where justified by the 12 risk to the patient, and only where voluntary standards or 13 compliance with these standards are inadequate. These are-14 .high- risk procedures; therefore, there is justification ) 7-s 15 from the risk. standpoint. And what I am hearing from the ( 16 . speakers today is that there are not voluntary standards out 17 there to address this in all circumstances. So it flows i 18 through our medical policy statement that this ought to be 19 something we do. 20 CHAIRMAN STITT: Right. Other commentary? We'll 21 go around the table. Anybody else on this limb of the 22 table? 23 MS. HANEY: I would just offer that I'm not sure i 24 that we can discuss the at least philosophical approach to 1 25 400 and 500 and 600 without considering what's going on in O l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 5
139 1- the 100- 200 range. What I am hearing is that the status 2 quo for 400 and 500 is saying that clinical experience and 3 radiation safety handling experience, you cannot separate 4 them; that you need all three years to do that. So my 5 question is, jumping ahead, why doesn't that also apply in 6 the 100- 200 space? 7 CHAIRMAN STITT: Dennis? 8 MR. SWANSON: I think an easy answer to that would 9 be the second - - tr.e first cause, where justified by the 10 risk to the patient. I don't think in categories 100 and 11 200 that there is a substantial risk to the patient, and 12 therefore, you know, the considerations go away in that 13 area. 14 CHAIRMAN STITT: John? () .15 MR. GRAHAM: Yes, a clarification on the second of 16 the motion was the fact that implicit in seconding Jeffrey's 17 motion, 100, 200, 300, 300 clearly becoming a gray zone, he 18 did not recommend a change to that table. It was 400 and 19 600 that we are recommending a specific change to the 20 requirements. Indeed, as Dennis said, it is only because 21 there has been considerable discussion that would appear to 22 justify that the risk to the patient cannot be separated 23 from the clinical training that is part of this form of 24 practice. l 25 CHAIRMAN STITT: Naomi? l l O ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034 N_______--_________________.___-___.___--__ _ _ _ _ _ _ _ - _ - - _ _ - . . _ - - _ - - . . . - - - _ . . _ - . _ . . _ - _ _ _ _ _ - - _ .. -
140 1 DR. ALAZRAKI: I think in 300, clearly the risk to (~') 2 the patient is similar. I mean you are dealing with
\J 3 hundreds of millicuries there, thyroid cancer, and for other 4 cancers that are being treated now with 300 millicuries of 5 iodine- 131 1&oeled to various moities.
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6 So I think clearly if it applies to 400, it l
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7- applies to 300. And so I am not a - - I can't propose any 8' candidate. 9 CHAIRMAN STITT: We'll stick with four and six 10 right there. John had just one small addition. 11 MR. GRAHAM: Well, that was my recommendation, at 12 least if we could try to get to an agreement on 400 and 600, 13 then this group can debate either before or after lunch what 14 they want to do with 300. () 15 Dan, did you have something? 16 DR. FLYNN: The reason why Jeff's comments - - I , I 18 th rd and mos impo t nt factor w s h th7. e years o 19 training. 20 CHAIRMAN STITT: Right. But that's not what he's 21 -- 1 i 22 DR. FLYNN: And I think for 300, 300 concerns me j l 23 because included in 300 are isotopes, therapeutic isotopes ; 24 which - - bone- marrow suppressing and potentially fatal, ; 25 and I don't think that endocrinologists and diagnostic ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 t___----_________---_____ _ _ _ _ . - - - - - - - - - - - - - - - - - - - . - - _ _ - - - - - . - _ - - _ _ - - - - _ _ _ _ - - - - - _ - - - - - _ - - _ - - - - - - - - - - - - - - - - - - - - . _ _ _ .
141 l l 1 radiologists are usually monitoring patients carefully in ) [ 2 ' terms of their blood counts to intervene in case that 3 patient is facing a fatal complication. I 4 CHAIRMAN STITT: There was some arm- waving over 5 here regarding the' motion. 6 DR. WAGNER: I'm not quite sure I understand the
.7 motion.
8 CHAIRMAN STITT: The motion is to retain status 9 quo. i 10 DR. WAGNER: Well, I don't - - that didn't seem 11 to be consistent with what he said; that's why I'm confused. 1 12 The status quo would be - - would include the 200 hours 13 didactic, 500 hours practical supervised experience, plus 14 the.three years. Is that correct? Or were you throwing out q,j/ 15 the 200 and 500? I 16 CHAIRMAN STITT: No , we're leaving it as it's ! 17 written in the current regulations. j 1 18 DR. WAGNER: Because I heard you say - - you said 19 instead of the 200, 500. 20 MS. WALKUP: Instead of board certification. 21 DR WILLIAMSON: I said alternative to board I 22 certification. The current - - I'll read you what the : i 23 current one says, if you want me to. This is - - I'll take i 24 teletherapy, for example. 35.960. Training for. I 25 teletherapy. Except as provided in 35.970, the licensee
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142 1 shall require the authorized user of a sealed source listed () 2- in 35.6 in a teletherapy to be a physician who (a) is 3- certified in radiology, therapeutic radiology or radiation 4- oncology by the American Board of Radiology, and then it - 5 lists some alternative ones which I-won't read; or (b) is in 6 the active practice of therapeutic radiology and has had 7 classroom and laboratory training in basic radioisotope ! 8 techniques applicable to use of sealed source in a 9 teletherapy unit, supervised work experience, and supervised 10 clinical experience as follows, 200 hours of classroom - - 11 and I won't read everything that's included'- - 500 hours 12 of supervised work, and (3) three years of supervised 13 clinical experience that includes one year in a formal 14 training program approved by the residency review committee () 15 for radiology of the accreditation council for graduate 16 medical education or the committee on post- doctoral 17 training of the American Osteopathic Association, and an 18 additional two years of experience, clinical experience in 19 therapeutic radiology. 20 DR. WAGNER: Are you specifically recommending 21 also that we retain the naming of all the boards within the. 22 recommendation? 23 DR. WILLIAMSON: No, not necessarily, no. I i 24 wouldn't say that my motion is so rigid that it would have 25 to include every letter, but sort of the basic elements ANN RILEY & ASSOCIATES, LTD. O- Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 u _ _ _ _ _ -- _ -- _ -_--_- _ _-- _-- ___ _-.
143 1 would be a longer clinical training and experience, and () 2 retreat from this what I consider fallacious attempt to try 3 and separate patient safety from clinical competence of the 4 provider. 5 DR.' WAGNER: Thank you very much. 6 CHAIRMAN STITT: All right. Does the committee 7 understand? John doesn't understand. 8 MR. GRAHAM: Having seconded the motion, it was a motion to retain the status quo which I interpreted as the 10 existing regulation language in Part 35 which was currently 11 number 35.960 versus the adoption of the language which is 12 in 35.690. 13 Now, folks, we're headed down a regulatory road 14 here, we're accepting that there is a component of patient 15 safety that requires a set of standards. We're saying that 16 there were voluntary standards that are linked to residency l 17 programs and board certification that would meet that need 18 and I don't see how we write this without specifically 19 listing them once again, and I thought that's what I was 20 seconding. So I'm at a loss if we're not - - we're going 21 back to what's in there ) i 22 DR. WILLIAMSON: Okay, I will amend my proposal t.
- j. 23 then to include the various boards that are listed in the i 24 current Part 35 under 35.960, if that will be helpful.
l 25- CEAIRMAN STITT: Does that make you happy, John? ANN RILEY & ASSOCIATES, LTD. Court Reporters , l- 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 E_________ ____ _ _ _ _ _ __ _ _ _ _ _ _ _
144 1 MR. GRAHAM: In other words, the motion is to (n) . 2 retain verbatim the current language that was in 35.960 to 3 substitute for the proposed language that's in 35.690? I 4 would support that motion. 5 CHAIRMAN STITT: And that's what you think you 6 were seconding. All right. Other comments? Go ahead, Lou. 7 DR. WAGNER: I have a problem with that in that 8 you're putting into regulatory space the names of the board 9 certification agencies, and that has been a problem before 10 because you - - in order to get a change to that, you've 11 got to go through the regulatory process and get all the 12 regulations changed, and the whole intent of taking them out 13' was to prevent that so that the NRC could have flexibility 14 in making the necessary modifications in a timely manner, 15 rather than to put it into regulatory space. And that's why 16 I was specifically asking that question. I think that has 17 been the objection to having the names in the regulatory 18 space. It's not a matter that we want to change the 19 standards; it's a matter that we simply want to make it 20 easier for the NRC to be able to make the necessary l 21 modifications when those modifications present themselves. 22 CHAIRMAN STITT: All right. So I think the l-l 23 committee is getting the idea of what the motion is and what j 24 the concerns are. 25 Dan? r () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034 I i
145 1 DR. FLYNN: I don't understand why we can't, 2 without having a conflict, put American Board of Radiology 3 or equivalent and let the NRC decide what's equivalent, 4 because the American Board of Radiology, you know, they are 5 certifying the examination process of the American Board of 6 Radiology and Radiation Oncology, there's 200 candidates 7- examined every year in radiation oncology. l 8 Now for the osteopathic board of radiology, it's 9 one or zero per year. And, in fact, there are 80 training 10 programs in radiation oncology that are ACGME- approved. 80 11 programs in the country. For the Osteopathic College of 12 Radiology, it's - - there's only one or two programs. 13 There was one in Largo, Florida and one in Detroit, both of 14 which closed. The one in Largo, Florida was a freestanding 15 center with one radiation physician. And so it may be that 16 the - - and to be fair to the American Osteopathic Board of 17 Radiology, it may be that they develop in the future, or l 18 that they don't and they have no training programs in 19 existence, but offer this sort of a shorthand version as to 20 how to get board- certified. 21 I think you can put American Board of Radiology as 22 being the principal organization, which it is - - no one's i 23 going to say that's not true - - and then say or 24 equivalent. 25 CHAIRMAN STITT: Other discussion on this, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 I l-
146 l' specifically on this second aspect of the motion? The () 2 second aspect, because it's different than the first. 3 MR. GRAHAM: I just have a question to Lou. Does 4 that resolve your concern? 5 DR. WAGNER: Well, I guess I have a fundamental 6 problem. I wouldn't - - the problem is slaving it to the 7 American Board of Radiology. If the American Board of 8 Radiology changes.their standards, the question is should 9 - - do all the other ones then have to go meet that 10 standard? It becomes a little bit of a problem. Although, 11 you know, I agree with the idea of using the American Board 12 of Radiology as a standard, I'm not sure that I want to 13 build that right into the regulatory space as is, and my ) j 14 question would be, would it be okay to modify it so that any ir board- certifying body that encompasses the requirements of 15 i 16 the alternative, which would be - - which would mean that i 17 they require that the person undergo a training of this 18 caliber before they can be board- certified? l 19 CHAIRMAN STITT: Cathy has a comment to try to 20 clarify that. 21 MS. HANEY: What Lou is proposing is we take 22 paragraph (a) from the straw man and just replace - - put l 23 that into the place of paragraph (a) in the status quo. NRC l 24 would still be approving the boards and we would have this ( 25 list, but we would be approving it based on that board i I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 c_-___-____________-______--_--____-____-_-___ _ _ - _ - - - _ - _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ - _ - _ _ _ - _ - _ _ _ _ _ _ _ _ _ _ _ _ _- _ _-_-
147 1 meeting - - in order to sit for that board, that would have {mj 2 had to go through everything that's in (b). 3 CHAIRMAN STITT: Getting closer? 4 MR. GRAHAM: Can I get her comment as Staff on how 5 that would - - is that administrable - - that's a 6 terrible word. Can you work with that? Is this going to 7 create something that from a regulatory standpoint you are 8 comfortable can be administered? 9 MS. HANEY: Well, all we are going to do is review 10 what ABR sends in to us and says - - and look at it to see 11 that in order to sit for this board would have had to have 12 200 hours of didactic training, you would have completed a 13 three- year residency. We'd just go down the hit list of 14 what's in (b). And if the answer is yes, then you would (_) (_/ 15 become approved for - - as an approved certifying body. 16 We would also, I would guess, is probably bring it 17 to the ACMUI and say this is Staff's evaluation of this 18 particular organization's filing or requesting to become 19 certified; do you agree with us. 20 DR. FLYNN: Instead of just sending it to Staff, 21 could you send it out to the professional community to make 22 sure that it is not some board process that becomes a sort l 23 of a money- maker in terms of administrating boards that are 24 easily passed for a fee? 25 In other words, what is to prevent someone writing l l l (' 'y ! ( / ANN RILEY & ASSOCIATES, LTD. ! Court Reporters ; f 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 L___.._.__.. _ _ _ _ _ _ _ _ . _ _ . - - _ _ . - - . _ - . . - - _ - -
148 l l' 1 .you a letter saying we are the American Board of XYZ, and we fT () 2 are going to provide an examination process, provided these 3 candidates do this, and we're going to charge them $1000 to ! 4 'take the exam, and it's a shorthand version. Let's say it 5 is an exam which doesn't have the same standard as the 'j 6 .American Board of Radiology. 7 DR. NELP: It has to be approved by the AMA. 8 DR. FLYNN: No , it doesn't. No , the AMA - - 9 MS. HANEY: I guess to answer your question, I 10 think it is doable. We've got that proposal in the straw 11 man and no one has stopped us yet and said it wouldn't be a 12 problem. We probably wouldn't mail it out to professional 13 societies, but maybe we would have the option of issuing it 14 in the Federal Register and saying NRC is getting ready to 15 do - - to approve this; does anyone have any comments on 16 it. 17 So I think. regulatory- wise, we would be okay. ' 18 We'd have to work out a lot of details, though, and we would 19 involve the ACMUI in the final decision. 20 CHAIRMAN STITT: Let me tell you where-we are. I 21 We've-got Jeffrey's motion on the table, it's been seconded, l 22 and my understanding of the motion is that it's been l i 23 basically discussing two components. One is that the l l '24 training and experience remains the status quo regarding the 25 clinical experience and all the hours.as stated, and the l () ANN RILEY & ASSOCIATES, LTD. Court Reporters < 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 (202) 842-0034 ;
149 1 second component has to do with the board that would () 2 administer the testing. So those are the discussions that 3 we are having. And this focuses on 35.4 and 35.5, so we can 4 have final discussions, and then we'll need to vote. 5 Dr. Cerqueira? 6 DR. CERQUEIRA: I think it's a mistake to sort of 7 enfranchise a board, and we've kind of tried to break away 8 from that in looking at what it really takes for radiation 9 safety, and I think to name a specific board is sort of 10 defeating the whole purpose, which is really to just look at 11 experience and training in radiation safety to make certain 12 it's done. 13 I would disagree with the three- year program as 14 well, but I think to actually name a board really defeats 15 the whole purpose. 16 CHAIRMAN STITT: Jeffrey? And any other comments 17 to my left? 4 1 18 DR. WILLIAMSON: Well, I certainly would be 19 willing to accept a modification of my motion to - - which 20 I think is what we are discussing now. We are discussing a 21 motion - - a possible modification to the motion. 22 CHAIRMAN STITT: Right. 23 DR. WILLIAMSON: And the proposal that we are now ; 24 discussing is to replace paragraph (a) in the status quo 25 with something approximating the paragraph (a) of the straw l i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034 l
l 150 1- man _ training and experience requirement. c 2- CHAIRMAN STITT: i
' (("S} And Professor GraFam, I need a i 3 -motion.
i 4 Do you want to read what I think you MR. GRAHAM: i
-5 are making as a motion?
6 CHAIRMAN STITT: Well, we will have two motions on i 7 the. floor,,but we are good at that, so go ahead. 8 Well, we have - - you are amending his motion. , 9 MR. GRAHAM: Well,'potentially he is amending his 10 own motion. I am just trying to read back to Jeffrey what 11 his amendment was. I think it's now going to read that 12 'except as provided in section 35.57, the licensee shall 13 require the authorized user of manual brachytherapy source 14 for the uses listed in section 35.400 to be a physician who: 15 (a) is certified by a specialty board whose certification 16 process includes all of the requirements - - we're about-to 17 delete the paragraph I'm about to refer to. 'l i 18 I am sorry, back that up, it's going to be "whose 19 certification process has been approved by the Commission i 20 or" and then (b) reverts to the existing language as stated , 21' in section 35.960. l 22 CHAIRMAN STITT: Are people clear on what we're i 23 talking about? I think I am. l 24 DR. WILLIAMSON: Yes. L 25 MR. GRAHAM: No reference to the American Board of I i i 1 () ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300' Washington, D.C. 20005 (202) 842-0034
151 l 1 Radiology, the American Osteopathic Board of Radiology, the () 2 British Fellows of Faculty is in here, it simply states that 3 it is a physician who is certified by a specialty board 4 whose certification has been approved by the Commission. 5 CHAIRMAN STITT: Now, hang on, Naomi. Is that an 6 amendment to his? l 7 MR. GRAHAM: I was just trying to read back to 8 Jeffrey a clarification of what I think his final motion is. , .9 DR. WILLIAMSON: I think that's very accurate. 10 CHAIRMAN STITT: All right, are we considering a 11 motion, folks? 12 All right, we have a motion and a second. Let's 13 have final discussion, and we need to vote on what we've got . 14 on the table. 15 Naomi? 16 DR. ALAZRAKI: If you don't put the names of 17 boards which would qualify, where will these boards' names 18 Appear? How will anyone know which board? 19 MS. HANEY: We would put it into the NUREG. We 20 would probably put it on the NRC website. There would be a 21 master list maintained that would be easily accessible to 22 the public and professional organizations. 23 DR. ALAZRAKI: So it wouldn't be in regulatory 24 space but it would be in some commentary space somewhere? 25 MS. HANEY: It would not be in regulatory space, 1 l () ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters l Washington, D.C. 20005 (202) 842-0034
152 1 in a rule. It would not be in a rule. I \ b 2 DR. ALAZRAKI: In guidance space? ! 3 MS. HANEY: I don't want to say guidance, because 4- when you -- you know, with the discussion this morning with 5 guidance it's just like model procedures out.there, so 6 that's why I don't want to say in guidance. There would be 7 a list of NRC- approved organizations for 35- 100, there 8 would be another NRC list for 35- 200, and probably as we 9 add a new board to this list, we would at least notice it in 10 the Federal Register. 11 DR. WILLIAMSON: I think it would be somewhat 12 similar to the sealed source and device registry. 13 MS. HANEY: Yes, that's a very good -- 14 DR. WILLIAMSON: It's like an ancillary list and (A,) 15 process that's referred to in the regulations but not 16 outlined in detail how it works. 17 DR. FLYNN: Would it be available for comment 18 before it's finalized, though? 19 MS. HANEY: Well, that's -- I just threw that out 20 as a -- and when we got into the fine details, you know, we 21 could -- I think that would be maybe a subject of another 22 meeting if we approach this, you know, do you think we 23 should go out for comment before we finally approve 24 something. 25 CHAIRMAN STITT: Two comments from both ends of [ N ANN RILEY & ASSOCIATES, LTD. ; Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
153 1 this table,.and then unless anybody else is going to jump up () 2 and down and wave their hand at me, we're going to call a 3 vote. 4 MS. McBURNEY: Mine is just very quickly, I just 5 wanted to clarify that you're leaving out that whose 6 certification process includes other requirements in 7 paragraph (b)? 8 CHAIRMAN STITT: Cathy, do you want to comment? 9 MS. HANEY: No, I don't think so. You're just 10 really taking the (a) straw man and plugging it into the -- 11 MR. GRAHAM: Well, no, my reading of the motion 12 specifically excluded the portion of the sentence in the 13 straw man that referred to the requirements in paragraph 14 (b). 15 MS. McBURNEY: Even though you're replacing 16 paragraph (b) with all these new requirements. 17 MS. HANEY: You would still need to refer to (b) 18 in rule space, because otherwise they're going to say what 19 are your criteria for approving an organization. So an;in 20 we might as well tell them up front what the criteria for 21 approving it is. 22 MR. GRAHAM: Okay. So you're saying or (b) and 23 (b) will start out with is in the active practice of 24 therapeutic radiology and has had classroom, et cetera, et 25 cetera. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C, 20005 (202) 842-0034 L---. _ ---- - _ --.-_ _ - -.--. __ _ _ - - - - - - - . - - - - - . - - - - - - - _ - - - _ _ - - - - - - - - - - - - - - - - - _ - - - - - - - - - _ _ .
154 1 MS. HANEY: Yes, we have to do some -- (Q,f 2 MR. GRAHAM: As written in -- 3 MS. HANEY: Tweaking, but, yes. 4 CHAIRMAN STITT: Radiation safety officer and then 5 Lou. 6 MR. ZOON: Right. I just have one concern about 7 retaining the original language, because I think the rewrite 8 addressed another problem, and that was the reference to ll 9 classroom and laboratory training. The radiation safety 10 training paradigm is changing dramatically and the classroom 11 and the laboratory are disappearing from that paradigm. 12 We're going to computer- based and Internet training, and we 13 need to reflect that here. 14 CHAIRMAN STITT: I wonder if that's the phrase tO (ms/ 15 structured educational program. 16 Lou, and then -- 17 DR. WAGNER: Cathy, I don't know where it's going 18 to be discussed or if it's going to be discussed, but I 19 remember one of our -- at our session in Illinois we had 20 discussed the fact that as part of the qualifications we 21 demanded that the individuals also pass a test on these 22 radiation safety issues and that that test be administered 23 by a body independent of the training body. And we had 24 discussed that. And my question is, what happened to that 25 and where is it? l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
155 1 MS. HANEY: Well, now that you're going back'co i ) 2 status quo, Iim not sure. 3 CHAIRMAN STITT: And I don't know that it's the 4 same thing at all. I don't know that it pertains -- if we 5 were. I mean, we can adopt whatever we want. We may be 6 ignored, but I don't -- 7 MS. HANEY: Your issue was very important and we t 8 were -- we agreed very strongly with that. I'm not sure l 9 that it's now the same issue if we adopt the status quo. 10 DR. WAGNER: Well, we're not quite adopting the -- 11 MS. HANEY: Well, if you're going toward status 12 quo now, the radiation safety exam that we envisioned under 13 the approach up there on the screen doesn't really fit in 14 any longer. Now if you want to take status quo and say that (_) 15 the exam that's given by this accrediting body has to focus 16 on radiation safety or a certain component of it, then we're l 17 going to have to change the text in rule space of status l l 18 quo. ' l 19 DR. WAGNER: I know. l 20 MR. SWANSON: You can't make the argument that you
-21 separate -- I mean, we're making the argument here you can't i 22 separate patient clinical decisions from radiation safety. l 23' So now we've all agreed with that. So if we're going to i l
24 have an examination, it can't focus just on radiation 25- safety. It's going to have to focus -- (\- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L____________._.___.______________________________ _.. _._ . _ _ . _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ . _ _ _ . _ _ _ _ _ _ _ _ _ _ _ ____ _ ___ _
156 , 1 MS. .HANEY: That's right. 2 MR. SWANSON: It's going to have on the clinical 3 aspects also. Okay? 4 MS. HANEY: But I would tell you that a lot of 5 people that have spoken to us off the record have said that 6 the exams that they're taking for these boards have a very 7 small amount of radiation safety questions. So by taking 8 this approach we're acknowledging okay, these exams -- we're 9 not testing radiation safety knowledge.in these exams, we're 10 testing clinical competency. 11 MR. SWANSON: We're testing both. Okay? And the 12 exams are going to have to reflect both. And the certifying 13 organizations are going to have to take a critical look at 14 their examination processes to make sure that they address i 15 both. You can't have.it both ways. .Okay? 16 MS. HANEY: That's right. 17 CHAIRMAN STITT: I think Naomi had a comment. 18 DR. ALAZRAKI: I think when you require a board 19 certification, it's not just that you're requiring the exam, i 20 you're requiring the years of training and experience in the !
- 21 clinical environment which is really to my way of thinking l
.22 the essential part of what you're requiring.
23 CHAIRMAN STITT: Dr. Cerqueira. I 24 DR. CERQUEIRA: I'd like to get a little 25 clarification. I still think that intravascular l 1 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 j Washington, D.C. 20005 1 (202) 842-0034
i l 157 1 brachytherapy would most likely still. fall into the 35- 300 !( ( 2 category, but that's dealing really with unsealed sources. 3 What happens if you have strontium? Would that still be 4 eligible to fall into that? i 5 MS. HANEY: Yes, the whole concept of ! i 6 intravascular is we've as staff gone back and forth between ! 7 is it 300 or is it 400, and I think it's leaning more toward 8 400. 9 DR. FLYNN: It's intraluminal brachytherapy. { 10 What's the debate? I don't understand. 11 DR. CERQUEIRA: But it's single organ, and we've 12 sort of separated out, eye in the past and thyroid has been 13 separated out as well, and so, but I would -- ) 14 DR. FLYNN: It's a sealed source. What's the i N 15 problem? Sealed source. It's brachytherapy. It's 16 intraluminal brachytherapy, whether it's the esophagus, the ; 17 coronary artery, it's intraluminal, intracavitary 18 brachytherapy, intraluminal brachytherapy, like the l 19 esophagus. 20 DR. CERQUEIRA: But if you're dealing with, you 21 know, we've put in-the three years for clinical experience 22 because of the breadth of tumors that you would be treating 23 .with different sources. If you're doing a single 24 intravascular- based procedure, is it reasonable to require o 25 that extensive clinical experience? I () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
158 l' DR. FLYNN: Well, it's also -- the safety involves () 2 patient selection. If the patient has a prior history of 3 radiation, if they have a connective- tissue disorder, if 4 they've had prior chemotherapy, if their radiation 5 oncologist is not involved and they don't realize that maybe 6 the tolerance in the heart is somewhat dependent, if they've 7 gotten high- dose chemotherapy, even without radiation 8 therapy, the doses may be modified in this team approach. 9 DR CERQUEIRA: No, but still, if you're dealing 10 with a limited number of treatments, you know, you're 11 talking about GYN, you're talking about prostate, you're 12 talking about quite a few different organ systems, which is 13 what's included in that three- year training portion. 14 Right? 15 DR. FLYNN: Right, but the basic principle is the 16 same. If you do an intrastitial implant on the breast 17 versus the skin versus the tongue, it's still -- the basic l
-18 same principles of the brachytherapy is the same.
19 DR. CERQUEIRA: But some of the examples that were 20 given were really related to, you know, if you're going to 21 treat a uterine tumor, all the other shielding and things, 22 so I think it's very unrealistic to expect three years of 23 training in an area if you really have sort of -- limited 24 isotopes, limited radiation. 25 DR. FLYNN: But if the cardiologist does it with ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 1 1
159 1 the radiation oncologist, then it's a team approach and they ()n 2 don't have to worry about that. 3 CHAIRMAN STITT: I'm going to interject myself in 4 here because'it's getting late and the crowd's getting 5 surely. Bob Ayres gets to make a comment and we're going to 6 break for lunch, and we're not going to vote till after 7 lunch. So with a full stomach you'll have this peace of 8 mind and it will send us the right direction. We will -- 9 Ayres can comment, anybody else that can't wait and has to 10 speak before the break, and then we're going to reconvene at 11 1:30. 12 Cathy Haney will give us some thoughts as to 13 directions for lunch. 14 MR. AYRES: Thank you, Chairman Stitt. 15 I just thought I'd clear up a point of confusion. 16 The status quo with intravascular brachytherapy right now, 17 the isostents are being approved under 35- 300 because they 18 aren't -- were initially considered sealed sources because 19 of the leachage -- leaching of the P- 32 from the source. I 20 think we're going to revisit that, and that might be 21 changed. All the rest are being approved under 35- 400, and 22 all of the rest of the systems that I'm aware of that are 23 coming would be~35- 400 materials. 24 CHAIRMAN STITT: Thank you very much. 25 Other comments from the group? l i ANN RILEY.& ASSOCIATES, LTD. Court Reporters
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160 1 All right. We're going to be back here at 1:30. I 2 . [Whereupon, at 12:30 p.m., the meeting was ! i l 3 recessed, to reconvene at 1:30 p.m., this same day.] 4 5 6 7 8 4 1 9 ; l 10 11 l 12 l 13 14 15 16 17 18 19 l 20 21 22 l 23 24 25 ANN RILEY & ASSOCIATES, LTD. Court Reporters I 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
161 1 AFTERNOON SESSION () 2 3 {1:30 p.m.] CHAIRMAN STITT: It's exactly 1:30, we are back on 4 the record, and we are'all' full and ready for our nap. 5 You know what I wish we had is the - - remember 6- our meetings where we had the capacity to put what we were 7 talking about on - - 8' .MS. HANEY: I can tie it to that screen, a n d I ' l l... 9 put up there. 10 CHAIRMAN STITT: Well, since we have had to 1 11 re- discuss on.several occasions what we are talking about, 12 do you folks need to see in front of you, do that we are all 13 talking the same language? 14- Oh, everybody is feeling really confident. Good. 15 So no complaints when you realized you voted on something 16 slightly different. 17 MS. HANEY: Let me tell.you what I think you are 18 voting. 19 CHAIRMAN STITT: All right. Let's have the 20 official NRC representative ~tell us what we are doing. 21 MS. HANEY: Then we will see how well John and I ' 22 agree. 23 CHAIRMAN STITT: That will bring up the - - i i 24 MS. HANEY: Okay.. For 35.400 and 600, we are i 25 using status quo, current status quo. Replace A in status ! () i ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 (202) 842-0034 l 1
162 1 quo with A from the straw man. Everything else would stay () 2 the same as it is in the current status quo. 3 CHAIRMAN STITT: Cathy makes it sound very simple. 4- Now, two minutes of discussion. That means you 5 guys got a minute, and you guys got a minute. Don't say 6 anything I don't want to hear. 7 MR. GRAHAM: I would offer a friendly amendment to 8 Jeffrey's original motion, which would be exactly the same 9 as Cathy's summary, with the inclusion at the end of the 10 retained Part B, adding the statement that following 11 completion of the requirements in paragraph B of this 12 section, has demonstrated sufficient knowledge in radiation 13 safety commensurate with use requested by passing an 14 examination given by an organization or entity approved by < ) 15 the Commission in accordance with Appendix A of this part. 16 CHAIRMAN STITT: So you are adding - - 17 MR. GRAHAM: I am recommending that as a friendly 18 amendment to the original motion. 19 CHAIRMAN STITT: Is that different than an 20 unfriendly one? 21 .MR. GRAHAM: It depends on whether he accepts it. 22 CHAIRMAN STITT: Does somebody want to second?
- 23. DR. WAGNER: Is this a leveraged buyout?
24 CHAIRMAN STITT: Does anybody want to second that 25 so we can discuss it? Yes, sir. l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
163 1 MR. SWANSON: Second. f {%) 2 CHAIRMAN STITT: You second. Do you want to 3 discuss it? 4 DR. WAGNER: Second them, or do you just have the 5 person have to deny the amendment? 6 MR. SWANSON: Oh, I don't know. 7 MR. GRAHAM: Let's not get into a debate of 8 Robert's Rules on Sunday afternoon. 9 MR. SWANSON: Call the question. 10 CHAIRMAN STITT: Lou, what do you think about 11 that? 12 DR. WAGNER: It's great. 13 CHAIRMAN STITT: He loves it. I 14 MR. SWANSON: I call for the question. (~N i j 15 CHAIRMAN STITT: All right. I think lunch was ( 16 very beneficial. We need to start with the amendment, vote 17 on that. 18 DR. WILLIAMSON: Well, let's see the intent is for i 19- someone that has not passed the Board exam from one of the 20 approved Boards, that in addition to satisfying the current 21 status quo, dare I use the word, alternative pathway 22 requirements, they, in addition, have to take an examination 23 by somebody, not necessarily a Board examination. 24 MR. GRAHAM: Right. 25 MR. SWANSON: But it has to be approved by the l (_) ANN RILEY & ASSOCIATES, LTD. Court Reporters l
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i i i 164
.1 Commission.
(~N .
-Q- 2, CHAIRMAN STITT: Right. Okay.
3 ~DR. WILLIAMSON: Okay. l i 4 CHAIRMAN STITT: Great. We are going to vote on 5 the amendment. I think everybody is clear on what the 6 friendly amendment is. 7 All-those.in favor of the amendment? Motion? 8 Only vote if you are official members. 9 Those opposed. 10 (Amendment agreed to 9 to 0.] l l 11 CHAIRMAN STITT: Ready to vote on the motion? All 12 those in favor? All those opposed? 13 [Williamson motion agreed to 9 to 0.] , , 14 CHAIRMAN STITT: We are on a roll, folks. if ! 15 Okay. Take a deep breath, we will figure out 16 where we are going next. 17 okay. I thought maybe you would say something 18 .different. 100, 200, 300. 19 I open it up to comments. Let's do a little 20 discussion before we hear a motion.
- 21. DR. NELP: This is in reference to the revised 22 100, 200, 300.
23 CHAIRMAN STITT: Well, training and experience, l 24 structured educational program that you.see up there, points 25 100, 200. l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 (202) 842-0034
l 165 1 DR. NELP: But as it has been revised. ! l t 2 CHAIRMAN STITT: Yeah. Or anything else we want
%./
3 to do with that area. 4 Naomi, go' ahead. 3 1 5 DR. ALAZRAKI: 100 and 200 are diagnostic. 300 is 6 therapeutic. And I, personally, I think, you know, times 7 have changed since this was originally written, and we are 8 now using large. amounts of I- 131 and other traces other 9 that sodium iodine for therapy. And in my estimation, the i 10 risk' involved there is very high, both for personnel and for 11 patients. And that should be in the same category as 4 and 12 6, in my estimation. I mean if we are going to be 13 consistent, I think the risk level here exceeds the risk 14 level for much of - - not all, but for much of it. The A (_sI 15 risk level is considerable. 16 CHAIRMAN STITT: Go ahead. Thank you, Naomi. 17 Dan. 18 DR. FLYNN: I think also to reiterate, in 35.300, 19 I think it is fair to distinguish between Iodine- 131 and 20 bone marrow suppressing isotopes such as P- 32 which has - 21 always been, for the most part, maybe I am overstating, but 22 for the most part been under the purview of radiation 23 oncologists using P- 32. And the concern would be also with 24 Strontium- 89 and other isotopes which suppress the bone 25 marrow in cancer treatment should be under the purview of i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 l (202) 842-0034 _ _ _ - - _ - - - - - - - - - - - - - - - - - - _ _ - - - - - - _ _ _ - - - - a
166 1
'l . cancer physicians. ,-s 1 1
( j 2 Because, if not, what is going to happen you may 3 have a non- cancer physician, you know, referring a patient 4 to another non- cancer physician for a cancer treatment, 5 which is potentially dangerous. It terms of clinical 6 practice, that is outside of the NRC. But in terms of the i 7 safety aspects on the patient, includes the effects on 8 tissue, includes the effects on the bone marrow, of giving 9 too high or,too low of a dose or not monitoring the results 10 of this therapeutic procedure. With Iodine- 131, you don't 11 have the problems you have with P- 32 or Strontium- 89. 1 12 So I think 35.300 is divided up into - - I think 13 two parts, bone marrow suppressing radio isotopes versus 14 non- bone- marrow suppressing isotopes. jw
.15 CHAIRMAN STITT: Dr. Cerqueria. ;
16 DR. CERQUEIRA: Yeah, I think we are - - you 17 know, again, if we have - - we have tried to keep this on 18 the issues of radiation safety. And now I think we are sort 1 19 of going beyond that. Again, here for the people in
'20 endocrinology, and I think for the intervascular 21- brachytherapy people, again, we are dealing with a limited 22 range of isotopes. We are dealing with a more limited 23 number of diseases. And I agree with Naomi that we are 24 using more I- 131 treatment, but the risks, certainly in
- 25. terms of the radiation safety aspects of it, are very ANN RILEY & ASSOCIATES, LTD.
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167 1 similar, whether you are using 8 millicurie versus whether f( ) 2 you are using 200. Just in terms of the basic radiation 3 safety knowledge that you need to have. 1 4 CHAIRMAN STITT: Naomi, and then I will come over 5 at the other side. 6 DR. ALAZRAKI: Not at all, Manny. I think the 7 radiation safety practice and risk involved is much much 8 greater. When we do some of these I- 131 therapies, and i 9 this is 70t capsule, this is IV, what is involved in moving 10 to a hospital bed, we have a team that goes with us for 11 this, which includes the radio- pharmacist, it includes the i 12 radiation safety officer. It includes the nuclear medicine i 13 physicians. I mean this is a different dimension from 14 'giving a capsule to treat hyperthyroidism. () 15 , CHAIRMAN STITT: I am going to let this dialogue 16 go on a little bit and then I will come over there, I 17 promise. 18 DR. CERQUEIRA: But, again, I agree with you, it 19 is a team concept. But when you have got a team concept, 20 again, the amount of training and experience required for 21 each individual pergon isn't going to vary that 22- 'significantly. 23 CHAIRMAN STITT: Are you two arguing isotopes, do 24 you think? 25 DR. ALAZRAKI: This is - - what I am trying to O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
168 1 say is that if we are talking about risk to personnel, as () 2 ~ well as patient, but personnel, significant risk in handling 3 this material, this is not to be taken lightly. It doesn't 4 belong in a diagnostic category. It belongs at the way you 5 treated the 400, 600 category. The risk is high. ! 6 CHAIRMAN STITT: And you are specifically talking 7 about therapeutic I- 131. 8 DR. NELP: Are you talking about antibody therapy 9 or are you talking about I- 131 carcinoma, the thyroid 10 therapy? i 11 DR. ALAZRAKI: Well, I am talking about in the 12 -- all of the high dose I- 131s. The ones which are the 13 most risk are things like I- 131 MIBG, and the I- 131 14 antibody stuff, certainly, would probably be in-that
) 15 category, because you are dealing with hundreds of 16 millicuries.
17 DR. HOLDER: Can I give a point of information? 18 Just, Miss Madame Chairman, is it out of order to? 19 CHAIRMAN STITT: Well, you do have to be 20 recognized and I have to put you in an order. What do you 21 think? These guys have waiting patiently. Shall we let him 22 go ahead? 23 DR. NELP: No. 24 CHAIRMAN STITT: You are standing up, you can go 26 ahead. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
169 1 :DR. HOLDER: I just wanted to say that we give () 2' many times over 400 millicuries of I- 131. There's a lot of 3 things that people are doing to treat aggressive thyroid 4 cancer today and we get bone marrow suppression, and we 5 admit patients for that. So I think that unless you are 6 planning to go isotope by isotope, and many people would say 7 that the training crosses isotopes so that in many nuclear 8 practices, just for your information, they give 9 Strontium- 89, they give high doses of iodine. They do get 10 marrow suppression. And so I think from the radiation 11 safety aspects there, it is significant. 12 DR. FLYNN: But endocrinologists are giving 400 13 millicuries of iodine? t 14 DR. HOLDER: I don't really know any 15 endocrinologist personally, and I have only practiced in 16 three states in my career, who really do much treatment now 17 anyway. l 18 DR. FLYNN: But I am not talking about nuclear ! 19 medicine physicians. I would be talking about i 20 endocrinologists, if they are giving isotopes that suppress ! 21 the bone marrow, and you have fatalities, then I would be i 22 concerned about that section, if I am wrong. 23 DR. HOLDER: Well, the only thing that I would say 24 is is that somebody earlier said what you are trying to do l 25 is regulate those aspects of safety that occur because what l , t () ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters l Washington, D.C. 20005 (202) 842-0034
170 1 you intend doesn't happen. So that if somebody is handling () 2 200 millicuries for therapy on a routine basis, or 150, as 3 you are implying that some endocrinologists may be doing, I 4 mean I don't care whether they are radiologists or ! 5 endocrinologists, they had better be trained. 6 So, as you know, now the regulations don't just i l 7 let a diagnostic radiologist give radioactive iodine 8 therapy. 9 DR. FLYNN: Right. 10 DR. HOLDER: They have to get special 11 certification, and I don't think that is inappropriate. 12 DR. FLYNN: I agree with you. 13 DR. HOLDER: Maybe some of my radiology colleagues 14 may not like me to say that. 15 DR. FLYNN: After training in diagnostic 16 radiologist, you can pursue a track where you get, they call 17 it a diagnostic nuclear - - a diagnostic radiology / nuclear 18 fellowship, or you can do nuclear medicine, I assume, like 19 you did. 20 DR. HOLDER: Or you can do - - 21 DR. FLYNN: But in either case, you have the 22 training. 23 DR. HOLDER: Or even in regular diagnostic 24 radiology, if during that training period, you have had 25 additional training in delivering therapy that is coupled j () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
171 1 onto all of the other training you have. () 2 DR. FLYNN: That doesn't happen. Not - - I have
-3 talked to diagnostic radiology residents in various programs 4 and they are doing imaging, but they are doing - -
5 diagnostic radiology residents are not trained to deliver 6 therapy. i 7 DR. HOLDER: It depends on the program. 8 CHAIRMAN STITT: Are there comments along the left 9 line here? Several people have been waiting. Start with 10 Dennis. 11 MR. SWANSON: A couple of points of clarification. J 12 Naomi, you said that you think that therapy with unsealed 13 sources, 35.300, should be treated the same ab 35.400 and 14 35.600. So what you are saying then is, for clarification,
) ?.5 that training and experience would require 700 hours of 16 trainina,in a structured program and three years of 17 supervised clinical experience. Is that what you want for 18 that category?
19 DR. ALAZRAKI: Yes. That's correct. Isn't that 20 what right now - - 21 MR. SWANSON: No, currently, training for 22 therapeutic use of unsealed sources requires 80 hours of 23 structured training and five cases, in the case of the
)
24 thyroid cancer, or ten cases for hyperthyroidism. ! l 25 DR. ALAZRAKI: Yeah, that, I mean I know that the O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 1 L- _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . -. . _ - _ _ _ _ . _ _ _ _. - _ _ _ _ _ - - _ _ _ - _ _ _ _ - _ _ - - - - _ _ _ - _ - _ _ _ - _ _ _ _ _
172 1 regulation says hyperthyroidism, and I think it does say () 2 3 thyroid cancer, too, I just don't understand how that is possible, that the diagnostic criteria were 600, or 600 4 hours plus 600 hours, or however it broke down, and that 5 therapy - - it just doesn't make any sense whatsoever, to 6 me. 7 But if we are talking about risk- based regulatory 8 modifications now, the risk here is clearly the same as the 9 risk in the 400, 600 area, and I would say that you need 10 adequate training and experience demonstrated by ACGME 11 approved Board certification, or some equivalent, if you 12 would like, in those hours, as you did for the 400 and 600 13 level cases. 14 MR. SWANSON: So what you are saying is 700 hours
) 15 of training in a structured program, and three years of 16 supervised clinical experience in order to do thyroid '
17 therapies, to use greater than 30 microcuries of 18 Iodine- 131? 19 DR. ALAZRAKI: If you are not in a Board 20 certification program and demonstrate a number of - - l 21 MR. SWANSON: I understand, the Board i 22 certification program would have to provide equivalent l 23 training to that. ; l 24 CHAIRMAN STITT: Cathy has got a comment. l 25 MS. HANEY: Well, I would just say while you are l t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
173 1 looking at this, this is a case where we are looking at r~g (j 2 increasing the number of hours. If we were to go.35.300 and 3 take it up to the 400 and 600, what is typically asked of me 4 is, you know, what is broke and where - - what is the data 5 base to show that the problems are out there that you need 6 to increase this? 7 Now, if they are there, you know, then that is a 8 certainly a good enough reason. But as you are discussing 9 this, I would like some input on what is wrong with the 10 current. 11 DR. ALAZRAKI: Well, you almost have to look at 12 who is doing these therapies right now. Is it the trained 13 people? And I would suspect that in large part, it-is the 14 trained and experienced people with Boards in nuclear
} 15 medicine, or special competence in nuclear radiology who are 16 largely doing this.
17 CHAIRMtN STITT: Okay. We'll let Robert comment, 18 and then we will go to members of the public that have any 19 questions. 20 MR. ZOON: Just, sort of observing this 21 discussion, I still detect this confusion about which is the 22 at- risk population that is driving the discussion here, 23 whether it is the patient or everyone else involved in 24 actually performing the therapy. 25 The only reflection I might make, in an ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i _ - ---_-__---- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - -------------------------------J
174 l' institution'like ours, many RSOs that I have talked to, () 2 there isua tremendous-support network that is provided by 3 our program to these types of therapies, whether they are 4 .monoclone antibodies'- - carcinoma and so forth. And, you 5 know, I assign a health physicist to each one of these. We
- 6. have many staff involved with the patient and so forth. And 7 so as long as you have that type of program in place, if we 8 are talking about the radiation safety aspects of these, I 9 don't see the need to increase the training for the 11 0 clinicians involved. ,
i ill CHAIRMAN STITT: Members of the public. 12 DR. BASKIN: Maybe I can clear something up. 13 Endocrinologists treat hyperthyroidism as out- patients. We ; 14 don't put patients in the hospital. We'give less than'30
.15 millicuries of I- 131. I don't know of any endocrinologist 16 that has ever given amounts of radiation that you are 17 talking about here. Perhaps somewhere it happened, but I I 18_ sure don't'know about it, and I would say that 99.99 percent 19 of all the patients who we treat are well within the range 20 that we treat them as an out- patient. We are treating for 21 hyperthyroidism. I, personally, and most endocrinologists I 22 know that treat with radio iodine refer our cancer patients 23 over to the radiation oncologists and nuclear medicine for i
24 them to be treated. 25 . What we don't want to see, though, is that t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N . W .. , Suite 300 Washington, D.C. 20005 (202) 842-0034
175 1 endocrinologists who we feel are perfectly adequately 2 trained to treat patients for hyperthyroidism going to no 3 longer be able to do this, but have to refer patients out to 4 a different place, to a different specialty, to a different 5 locale, and have them treated elsewhere. The risk 6 associated with misadministration by referring the patient, 7 the loss to follow- up, seems to outweigh any potential risk 8 and we don't know of any risk with the present system. 9 So we would urge that the Rule 35.992 be 10 maintained, that treatment for hyperthyroidism, 80 hours 11 seems more than adequate for a person who is already Board 12~ certified in endocrinology to treat a patient for 13 . hyperthyroidism, and we don't see any risk. 1 14 DR. FLYNN: Yeah. My comment was on the bone
/~T l 15
%- marrow suppressing isotopes. There has been more than a few
)
16 deaths with strontium. There's not just one or two deaths, 4
- 17. there's been a number of deaths, and they can occur even 18 with the proper person giving the treatment, because these 19 are patients with advanced cancer, their bone marrow may be 20 infiltrated with cancer already, but they have to be 21 carefully monitored. And I think that you are more apt to 22 intervene and save some of these individuals from dying, at i 23 least in the short term, while you are palliating an 24 incurable cancer.
25 By having those who have had the experience and I ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
176 1 training and follow these patients to assess the response on (O/ 2 tissue - - .you know, simply assessing ~the response of very, 3 you know, potentially dangerous isotopes on the tissue, 4 which in this case is the bone marrow - - 5 MS. HANEY: Is this NRC's position, though? I 6 mean should NRC be there worried about those things, or is 7- that clinical? 8 DR. FLYNN: These are effects on normal tissue 9 that can result in death. 10 DR. BASKIN: Can you separate that isotope.out? 11 MS. HANEY: Can you separate that from where 12 radiation safety begins and where clinical, or is this 13 another-case of the 400, 600 that the clinical and radiation 14 safety are so intertwined that you can't? [ 15 DR. FLYNN: That's correct. I think they are 16 intertwined, and I think that the bone marrow suppressing 17 isotopes, not the rare bone marrow suppression, but the ones 18 that suppress bone marrow on a frequent basis, should be 19 under the therapeutic realm of 400 and 600. 20 CHAIRMAN STITT: Naomi, and then we'll come over 21 here. 22 DR. ALAZRAKI: According to what Dan just said, 23 that would include everything but less than 30 millicuries 24 of the I- 131 for the hyperthyroid. All of those others 25 -- (
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l 1 1 177 I 1 DR. FLYNN: And thus it wouldn't affect the 2 endocrinologist. v 3 CHAIRMAN STITT: Bill? 4 DR. NELP: I think the endocrinologists should be 5 permitted, with the proper training and background and j 6 experience, to treat hyperthyroidism, and with the new 7 release criteria, I don't think we should limit it to 30 i 8 millicuries. There may be an occasional case where you want 9 to go higher than that. The only new therapeutic 10 radiopharmaceutical that's been approved in the last 30 11 years is strontium, and all the radio- iodine products that 12 are being used for antibody therapy are all experimental, l 13 and it is highly speculative if they will ever be approved . 14 as a routinely- available substance.
.O (m,/ 15 I do think that the training requirements should 16 be~ enhanced. For instance, having experience with five 17 people to treat thyroid carcinoma, I think is very minimal, l l
18 but I do think we ought to separate out the endocrinologists
)
19 and say for the treatment of hyperthyroidism, and maybe set ' 20 a dose level - - occasionally you are going to use more 21 than 30 millicuries, but very, very rarely. 22 Those would be my comments. 23 CHAIRMAN STITT: Thank you. 24 MR. ZOON: Just a point of information, the i l 25- cut- off here is 30 microcuries, not 30 millicuries. ! () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
L ll 178 I 1 DR. NELP: No, no, I am talking about a new - - t ' /~5{ , i j 2 we have to set a new limit within this section. l 3 MR. ZOON: I agree. } 4 DR. NELP: Just to make it, you know, to keep the 5 status quo and to keep everything running smoothly. 6 CHAIRMAN STITT: Dr. Wagner? l 7 DR. WAGNER: I think it would be appropriate to j 8 split this out.into two groups, the patients treated on an 9 out- patient basis and patients treated on an in- patient 10 basis, split that group into two groups. Because patients 11 treated on an out- patient basis, clearly the radiation 12 safety issues involved with such patients are quite l 13 different than those who have to be treated on an 14 in- patient basis. j l s__/ 15 DR. FLYNN: Not with strontium. i i 16 DR. NELP: Not with strontium. 17 CHAIRMAN STITT: Cathy? 18 MS. HANEY: Well, also don't lose sight of the 19 fact that we have physicians now that are administering 200 20 millicuries of I- 131 and letting them walk out the same 21 day. 22 DR. WAGNER: I understand that; I understand that. 23 But you said strontium. Strontium - - 24 DR. FLYNN: Strontium is out- patient. 25 DR. ALAZRAKI: Maybe you ought to modify what l I)
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179 i 1 you're thinking on that, instead of going () 2 out- patient /in- patient, I- 131 under 30 millicuries versus l 3 therapy with any other unsealed source. 4 DR. WAGNER: I would probably - - that would be a 5 reasonable thing to do. I don't think I'd choose 30 l 6 millicuries, though; I think I would go a little higher l 7 because you can treat on an out- patient basis without -- 8 DR. ALAZRAKI: Well, I'd make it very clear that 9 it's hyperthyroidism. l 10 DR. WAGNER: Right; right. That's right. 11 CHAIRMAN STITT: All right, so we have got some 12 things out there we are talking about. Keep going. Go 13 ahead. 14 DR. CERQUEIRA: I just have a question. Clearly ( 15 training in nuclear medicine - - I am one of the new l 16 appointments.in the American Board of Nuclear Medicine - - ! 17 and you are talking about a two- year training program which 18 in a sense would say that a lot of nuclear medicine l J 19 physicians who have completed a two- year program would not ' 20 meet that requirement if you are going to require three 21 years of clinical, because the 400 and 600 series were put 22 at those hours plus three years of clinical training. So 23 . what you are saying is that these people would not be 24 eligible, you know, for having completed a nuclear medicine 25 training program to do that. l t ANN RILEY & ASSOCIATES, LTD. j Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
180 1 DR. ALAZRAKI: These are the hours in the event 2 that an individual.doesn't meet the board certification. Is 3 that correct? l 4 MS. HANEY: Well, what you are seeing on the 5 screen :us straw man, rule A, which was voted on this morning l 6 for the 400 and 600 is to keep the three- year program. 7 DR. ALAZRAKI: And in this case it would be a 8 two- year program because that's what the nuclear program 9 is, or the board - - the ABNM requirement of training in 10 nuclear.would be a two- year program, and the hours then, if ! 11- you do not have the board, one would be certified by another l 12 route would be the hours, and we could talk about an exam. 13 But these hours then are based on the equivalence of a 14 three- year program; is that correct? Is that what you are , /~N l ld 15 saying? 16 CHAIRMAN STITT: I don't know. 17 DR. NELP: We can make it anything we want to make 18 it. The fact that we have mentioned it should be like the 19 300 program is irrelevant. We should make it what we want l 20 to make it. We are not bound by anything. We should make 21 it what makes sense to us and what makes sense to the 22 community. It makes sense to me to separate out the 23 treatment of hyperthyroidism and everybody else should have 24 training equivalent to a nuclear medicine certification, or 25 something in that category. It doesn't have to follow ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 w - _________________ __- - _ -
181 1 anything that we have previously discussed. [d \ 2 CHAIRMAN STITT: All right, does that sound like 3 something we can talk more about? Dennis? 4 MR. SWANSON: Your two years of training in 5 nuclear medicine, though, that two years encompasses much 6 more than just treatment of hyperthyroidism and thyroid 7 cancer, et cetera, so you are going to have to figure out ; 8 what component of that training involves therapy procedures. 9 DR. ALAZRAKI: Well, just to be parallel to what 10 we just -- what the committee just did with external - - 11 with brachytherapy - - I mean their three years involves 12 more than just brachytherapy. ; 13 DR. CERQUEIRA: A lot more. 14 MS. HANEY: But that argument is based on the fact
'( ) 15 that you can't separate clinical and radiation safety, and 16 if we are going to make the same argument for this, then it 17 has to be the full two- year program.
18 CHAIRMAN STITT: Go ahead. 19 DR. NELP: It would seem to me that if you are 20 board- certified in radiology, if you are board- certified 21 in the specialty of nuclear radiology, and if you are 22 board- certified in nuclear medicine, you are capable, you 23 would accept those credentials. If you don't have those 24 credentials, you have to satisfy some level of experience 25 and training, and give some sort of examination that you l ANN RILEY & ASSOCIATES, LTD.
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182 1 would accept, and it is that simple. We already have these () 2 3' things in place. Then no one is going to be rushing in to give 400, 500 millicuries of radio- iodine therapy, i.e., I 4 think that is highly unlikely, only those people who are 5 qualified are even going to think about that. So I'd just 6 keep focused on what do you really want to happen. 7 MR. SWANSON: Let me emphasize it goes both 8 directions, okay, in that the amount of training and 9 experience you described as an alternate also has to be 10 encompassed within your nuclear medicine training program. 11 It's board certification or an equivalent, and it goes both 12 directions. If you say that in order to be appropriately 13 trained to do thyroid therapy as an alternate to board 14 certification, I'm going to require two years of training, 15 I'm going to require 700 hours of didactic material and 16 structured program, then you are going to have to make sure 17 that your board certification program that's addressing 18 therapy includes two years of training and therapy and 700 19 hours of didactic experience. It goes both directions. 20 DR. NELP: It's either or. Either or. A person 21 who trains for two years may see a hundred carcinoma 22 therapies, and you can do whatever you want to, they are not 23 - - 24 CHAIRMAN STITT: They do have to share an 25 equivalent. That's why they were set up originally. O- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i i
i 1 l l 183 l 1 Go ahead, Jeffrey. () 2 DR. WILLIAMSON: It doesn't sound like board 3 certification in radiation oncology would satisfy these 4 requirements, then. 5 MR. SWANSON: It may or may not. 6 DR. ALAZRAKI: I would say for board _ certification i i 7 in radiation oncology, plus demonstrated experience with 8 handling the unsealed source experienced with some number, 9 reasonable number of cases. It's ten now in the regs, and I l 10 think it shouldn't be reduced, but I think that would do it. 11 DR. FLYNN: The Residency Review Committee 12 requires that there be so many hours in various categories ! 13 and so many types of cases and so many conferences and so 14 many departmental conferences and so many interdepartmental i 15 conferences in physics and biology. It's already specified 16 by the Residency Review Committee which monitors all the AB 17 programs in the country in radiation oncology.
)
18 DR. WILLIAMSON: I guess my point is - - 19 DR. FLYNN: Before it gets to the Board of 20 Radiology. 21 DR. WILLIAMSON: But that's for the current 80 22 hours of classroom training. What if it went up to 200 and 23 500? 24 DR. FLYNN: It's covered by conferences. It's 25 covered by - - I mean most departments have to show they () ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
184 1 have at least five to 10 to 12 hours of weekly conference.
,\
() 2 DR. CERQUEIRA: Dennis, I'm having a little bit of 3 a problem with - - you know, before you are going to be 4 doing this treating thyroid or treating certain types of 5 tumors, in the nuclear medicine two- year program, that is 6 not all you are going to be doing exclusively. So if you 7 are going to require somebody else to meet experience 8 criteria, then you really should require the people in the 9 field to be doing it. You can make the case that there is 10 some overlap in terms of radiation safety and clinical, but 11 the therapy and diagnostics are very clearly different, and 12 I think I would agree with Dennis, that if you are going to 13 require it for the people meeting it by experience, then you 14 are going to have to do it by the people that are - - you tO l
\~ > 15 know, as a result of a training program or a board 16 certification.
17 CHAIRMAN STITT: Any other comments on one, two or 18 three? 19 DR. CERQUEIRA: This was all done on three; right? 20 CHAIRMAN STITT: Yes. 21 DR. ALAZRAKI: It's all been on three. 22 I don't think - - we're talking, but I don't 23 think I've heard too much disagreement with the recognition 24 for the app;orriate board certification. What we haven't 25 come to is what's the alternative in terms of number of p,) ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i L_------______--_______
185 1 . hours. That's what we haven't come to. 2' . CHAIRMAN STITT: Do you have a suggestion? 3 DR. ALAZRAKI: I could make a suggestion, based on 4 the fact that we are talking two- year program and I also 5 sit on the Residency Review Committee for nuclear' medicine 6 and I am familiar with the nuclear radiology as well. Based 7 on the fact that it's a two- year program, I would say that 8 the equivalence might be 120 hours of - - instead of 200 9 there, plus in practical hours, something in the l 10 neighborhood of the equivalent of let's say three months, 11 plus demonstrated number of cases done under the supervision 12 of an authorized physician. 13 CHAIRMAN STITT: Does anybody want to check those 14 and talk about them? 15 DR. CERQUEIRA: Again I still have problems with 16 boards. If we are going to do boards, and we agreed we 17 would try not to make this a turf issue by just leaving it l 18 with some radiology and nuclear medicine boards, and it l 19 seems to me like we're going back basically to redoing 20 everything in terms of the boards without giving other 21 training programs that are incorporating some of these 22 things into them to be able to meet eligiblity criterion. l 23 CHAIRMAN STITT: Cathy? ! 24 MS. HANEY: If I could get you to turn to page 48 ; i 25 of the straw man rule - - it should be in the back of your l () ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
186 1 briefing books - - this is taking into 35.200 space, but () 2 when'we came up with the number of practical hours, we tried 3 to give an idea of what that practical hours would include, 4 and in this case you can see - - it's about midway on the 5 page there - - we have 40 hours of supervised practical 6 experience doing receiving, calibrating doses; it goes on 7 down that list. If you go down to three that we crossed 8- out, this was what was the old supervised clinical 9 experience. It was examining patients, selecting suitable 10 radiopharmaceutical; things like that. 11 Now over the years NRC has been unofficially told 12 that's none of our business, and maybe officially we've been 13 told that, too, but now what I'm hearing is if we are going 14 to up these practical hours, I'm putting those things back 15 in the rule. And is that what -- do you want those things 16 back in the rule in 200 space and in 300 space? 17 CHAIRMAN STITT: John? 18 MR. GRAHAM: I have heard about some very isolated 19 examples of radionuclides that could pose enough risk to the 20 patient and through the patient to the general public that l 21 they need to be covered with the same kind of training regs 22 as 35.400 and .600. I would be much more comfortable l 23 identifying those isolated incidents or situations or 24 nuclides and move them through some sort of language onto a 25 list that links it in with the brachytherapy list that's ANN RILEY & ASSOCIATES, LTD. Court Reporters , 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
l 187 1 going to be in here, and then leave 100, 200, 300 as we have () r 2 discussed it. 3 Otherwise, we are talking about jacking up the 4 training requirements on a section where 90 plus percent of 5 what's being done, I am told, it's okay, and we have some 6 new unusual applications that potentially need to be moved. 7 CHAIRMAN STITT: Naomi? 8 DR. ALAZRAKI: Well, I'm not sure you want to move ! l 9 them. They are different from the sealed source ' 10 j applications of 400. These are unsealed sources that we are 11 . talking about, and the traditional training programs which 1 12 deal with these therapies are not the same as, although they 13 can overlap, but not the same necessarily as the sealed 14 sources.
.f'~)
(s ,/ 15 ) So I would think you'd want to leave it here, j I 16 maybe take out the less than - - whatever we decided, 30 1 17 millicuries or hyperthyroidism therapies, out- patient 18 basis, and let's deal with all the other unsealed source 19 therapeutic agents in this categhory and go with the 20 appropriate board certification or the hours, which is what ! i 21 we are struggling with now. i 22 CHAIRMAN STITT: Bill? 23 DR. NELP: I would like to take you back 24 historically, Naomi. ; I 25 This committee was charged by itself and others to { ) () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
188 1 get out of the practice of medicine and we and I personally e'N (,) 2 am not concerned about physicians who are going to be out 3 there using -- this committee or the NRC is being charged to 4 look at safety issues. 5 I am not personally concerned from my own 6 experience with physicians who are going to go out there and l 7 recklessly use these things as a therapeutic mode, because I 8 think we have voluntary certification, hospital 9 certification practices that are going to keep this very 10 much in line, and unlike the radiation oncologists who are 11 concerned about the urologists and the eye surgeons and the 12 other people who do isotope therapy, I don't see this 13 happening. 14 Even though it is, quote, " dangerous to the (~) (_) 15 patient," that is the physician's responsibility and not the 16 NRC's responsibility. 17 DR. ALAZRAKI: That is not just dangerous to the 18 patient. This is dangerous to personnel. 19 DR. NELP: But the personnel are very safely 20 protected under the guidelines that are written here. 21 They know how to handle the material safely for 22 their own personal safety and for the safety of the people 23 in their environment. 24 DR. ALAZRAKI: Well, I am just trying to be l 25 consistent with what this committee did just an hour ago.
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189 1 DR. NELP: Right, and when we did what we did an () 2 hour'ago we just reverted back to getting the NRC in the 3 practice of medicine again -- 4 DR. ALAZRAKI: Well, that's what we did -- 5 DR. NELP: - - which I personally find 6 undesirable. 7 DR. ALAZRAKI: You voted for it. 8 DR. NELP: I did vote for it because it was a done 9 deal, but I would like to keep it at this level. 10 I am very much for getting the NRC cut of the 11 practice of medicine.
- 12. CHAIRMAN STITT: John Graham.
13 MR. GRAHAM: I would move that the ACMUI recommend i 14 the straw man language that covers 35.100, .200, and .300 as 15 documented. 16 CHAIRMAN STITT: Say that again. 17 MR. GRAHAM: That the ACMUI is recommending the 18 adoption of straw man language that covers 35.100, .200, and 19 .300. 20 DR. NELP: Straw man language? 21 MR. GRAHAM: Correct -- as documented on page -- I i 22 don't have all the page numbers -- as documented under the j l 23 tab, Part 35, Rule, Working Group Document. l 24 DR. NELP: Can we revise some of the English in 25 the details in here, or do you want in principle? I l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C 20005 (202) 842-0034
j i 190 l, 1 MR. GRAHAM: Yes -- yes, I am just trying to get a 2 motion on the floor -- 3 DR. NELP: Second. l 4 MR. GRAHAM: -- get that to closure. S- CHAIRMAN STITT: Okay. Talk. Dan?
-6 DR. FLYNN: Again the isotopes I was referring to 7 are not unusual or sporadic cases. These are, the isotopes 8 suppressing the bone marrows are more~ common than the ones 9 that don't, although perhaps iodine is the number one 10 isotopes in terms of the amount of use, but then iodine is a 11 special case.
12 In fact, if you look at the old NRC regulations, L 13 someone in their wisdom when they wrote 35.932, training for 14 treatment with hyperthyroidism, made that a separate section
, ~15 assuming if you make something a separate section in the 16- regulation someone was thinking that perhaps there may be 17 some differences that either come up in the future or exist 18 now but they couldn't -- in other words I didn't know why 19 did the NRC separate out 35.932 and 35.934, which is 1
20 treatment with thyroid cancer, from the other ones, which 21 are now 35.300. 22 Now we have isotopes that are going to be used
-23 much more commonly. They are being used very commonly 24 now -- Strontium 89 for example, unsealed source, which 25 have' devastating effects on the bone marrow -- P- 32 also in ANN RILEY & ASSOCIATES, LTD.
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191 1 unsealed source. I () 2 .DR. NELP: But we only have one more isotope than 3 we did 30 years ago and that is Strontium. 4 DR. FLYNN: But it is being used much more 5 commonly now,.and the problem now is that now it may be, if j 6 it is out of the hands of those who have the experience and { j 7 training in therapy than the risk to the patient is the' fact 8 that an unrecognized adverse harmful effect to the patient 9 in terms of radiation safety to the patient occurs with 10 something as serious as bone marrow suppression, which is 11 not -- it's not one and two cases. It is a common i 12 occurrence, even among the authorized users with the I 13 training -- to be able to monitor the -- and that is why the 14 American College of Radiology, which is mostly diagnostic l N_sI 15 radiologists, come up with a position that they have l l 16 published now saying this is in the purview of either l 17 nuclear medicine physicians or radiation oncologists, 18 leaving out diagnostic -- this is an organization of 19 diagnostic radiologists which has purposely left out 20 diagnostic radiologists -- that is very significant -- and 21 also stating that these patients need to be followed in the 22 short interim period for the adverse effects that these 23 isotopes may cause. 24 So'that is an example of a professional society 25 showing leadership in terms of voluntary standards, but they I L L I ANN RILEY & ASSOCIATES, LTD. Court Reporters-l 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034
l 192 ; I '^
- 1 are voluntary standards. What if -- you'know, if you water (p) 2: down the requirements what happens is the credentialling 3 committee at XYZ Hospital out in Montana says, well,.the l 4 Federal Government has in their wisdom backed off on this, 5 therefore it must be safe -- the credentials committee 6 -approves watering down the safety aspects of using this I 7 isotope because those in knowledge who have the Federal 8 mandate to protect the safety of patients have decided that i
9 it is not a problem, so we can water.down the training 10 requirements. 11 Then the credentials committee, what do you think 12 they are going to do? They are going to be formed of a 13 panel of experts on radiation safety? They are going to go
-14 along with whatever the NRC does, so if the NRC backs off, r~s !
(_ 15 they are going to see that as significant. 16 DR. NELP: That's hypothetical and I don't know, 17 do you know of the people who have had death from 18 Strontium- 89? Do you have how many people have died from 19 Strontium- 89 or have become ill? There is a difference. E 20 Inadvertent death from misadministration? 21 DR. FLYNN: Not misadministration but the effects 22 on tissue -- 23 DR. NELP: Yes. 24 DR. FLYNN: Four at the large institution that I 25 a'm affiliated with in Boston, four deaths. ANN RILEY & ASSOCIATES, LTD.
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193 1 DR. NELP: From bone marrow? O) (, 2 DR. FLYNN: Right. I talked to the radiation 3_ oncologist there. Four deaths at one institution in the 4 period of several years. 5 Now these patients have advanced cancer. They're 6 incurable. They are going to die anyway. The reason for 7 the therapy is to suppress the cancer to alleviate the pain, 8 but sometimes the bone marrow may be diffusely infiltrated 9 with cancer cells and you don't know if they have died 10 because of the therapy or because of the cancer, but even if 11_ you look at the -- if you look at the data that Amersham 12 supplies for Strontium- 89, they will go for the clinical 13 trials as to how many people have died or how many people 14 have, the percentage of patients.who have had severe Of 15 hematological effects, and it is significant -- but you have 16 no choice. 17 You are trying to palliate someone with advanced 18 cancer. 19 DR. NELP: Exactly, and you know, this is not an 20 unusual experience with chemotherapy. You get leukopenic 21 and get and infection and you'll die. 22 DR. FLYNN: But you don't have family 23 practitioners giving high dose chemotherapy and adriamycin. 24 DR. NELP: And you don't have family practitioners
- l. 25 giving Strontium- 89
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l 194 1 DR. FLYNN: You have the equivalent in some cases. () 2 DR. NELP: Well, I am not aware of that. 3 CHAIRMAN STITT: John, do you have a comment? ! 4 MR. GRAHAM: Well, I wanted to clarify that the 5 recommended motion was within the context of the other 6 language that is in each of these sections. 7 There are safety requirements. There's safety 8 instruction that's delineated in the regs, so we are not --
)
9 well, we are not watering down.the training requirements l. 10 that are in the Section 35.300, we are leaving them at the 11 level.that was in the earlier regulatory language, so we 12 aren't going to have a few people with minimal training that 13 go off and do this in isolation. 14 CHAIRMAN STITT: Dr. Kang? [ 15 DR. KANG: I was going to ask just one question to I 16 Dr. Flynn. I 17 We are talking about the training and experience, 18 right, and what you mentioned, a few deaths, from the 19 strontium therapy, are you implying that those deaths are 20 specifically all caused by the lack of the training or the 21 insufficient training? We are talking about the training? l 22 DR. FLYNN: No. It has to do with -- I was 23 emphasizing not the training but in that case how dangerous 24 it is to use this isotope if you have the training. 25 If you take away the training, it would be more () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
195 1 dangerous. If you_ allow people -- let's say for example not () 2 in nuclear medicine, let's say diagnostic radiology and some 3 showed an interest at our hospital, our community hospital, 4 for applying to be able to do it, to back up the nuclear 5 medicine physician who's gone on vacation, but if you not 6 following the blood counts, and a lot of times some 7 individuals who are trained in diagnosis primarily are not 8 following the blood counts, someone had better be following 9 the blood counts. 10 Recently I found one patient that I had treated 11 with. external beam therapy for metastatic disease to bone 12 that the urologist had referred the patient and nobody was 13 following the blood counts. I didn't realize the patient 14 was referred or got the treatment, but he was seen in a 15 routine follow- up exam and his blood counts were extremely 16 low and nobody was following the blood counts. 17 There wasn't a cancer physician involved in this 18 therapy. 19 CHAIRMAN STITT: There were several comments over 20 on this side. Let's do that and then Dr. Cerqueira. Jeff, 21 were you -- 22 DR. WILLIAMSON: Well, maybe a procedural ! I 23 suggestion. Perhaps it would be easier to take on 35.100 l 24 and - 200 and come back to what seems to be the most 25 contentious area, which is 35.300. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 . I Washington, D.C. 20005 i (202) 842-0034 L _ _ _ - - - _ _ - - . . - - - - . - - - - - _ - - - _ -
196 1 I suppose one thought we have to give is if we () 2 change the current training and experience requirements for 3 35.3 in reviewing the current Part 35 seems strikingly low. 4 It's what? Eighty hours of training and five 5 cases'or something, and there are provisions for 6 hyperthyroidism and thyroid carcinoma and all of the other 7 therapeutic radionuclides we're talking about are included 8 in that purview, and so I suppose one question would be if 9 we cort of dramatically force upwards the training and 10 experience requirements, how much dislocation might that 11 cause and how much, just how much sort of difficulty, how 12 much might it upset established referral and treatment 13 patterns. 14 CHAIRMAN STITT: I am thinking procedurally now. 15 I was hoping to attack -- pardon me -- 1 and 2 but much 16 invigorated 35.3 people right into our discussions. 17 We have a motion on the floor that we have to 18 address and that is to look at .100, .200 and .300 series in 19 supporting the straw man details, so we are going to have 20 some more discussion and a vote on this. 21 Naomi, then -- you were next. Go ahead. 22 DR. ALAZRAKI: Yes, I think we are getting back 23 into the practice of medicine again, and I agree with Dr. 24 Flynn that these are sick patients and certainly we 25 intentionally sometimes try to suppress their marrow in i. () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 ! (202) 842-0034 ; l L__________.______.______________ _ _ _ _ _ _ _ . _ _ _ _ _ _
197 1 order to get at the tumor, and there are safeguards in 2 -place, as John Graham said, to deal with this both in our O(s 3 regs and at regulatory levels -- at the state as well as the 4 Federal -- for the practice of medicine. 5- If some of you had listened to the radio this 6 morning coming in, somebody in Manassas, Virginia was 7 injecting patients with aloe vera to treat cancer. He lost 8 his license. 9 I mean there are things in place to do it. 10 What we are focusing on is the radiation safety 11 aspects, and I think it is' malpractice for somebody not to 12 be checking bone marrow on'these patients, who are getting 13 chemotherapy in many cases who are getting palliation for 14 bone treatment, so that is not an issue of radiation safety () 15 16 per se but rather the practice of medicine. CHAIRMAN STITT: Naomi and then the other side of 17 the table. 18 DR. ALAZRAKI: Well, I think we are still 19 addressing both -- .100, .200, and then .300 is a separate 20 issue. 21 I would like to try to address both but they have 22 to be addressed separately because they really are 23 different. 24 In terms of the radiation safety aspects, even if 25 we try to stick to talking about radiation safety with these ) O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 L___--_----__--____-------_--___-----_--____---_------- - - - - - - - - - - _ - - - - - - _ - - - _ - _ _ _ - - . - - - - - - - - - - _
198 1 unstaled sources being used for therapies, we have got 2 (~]
'NJ issues, major issues I think.
3 You cannot have someone use something like 4 Strontium- 89 who is not familiar with how to handle 5 unsealed sources of activity even if they have some i 6 theoretical knowledge about radiation sciences. 7 People tend to, who are not familiar, contaminate. 8 They tend to get it on their fingers and eat it or on their 9 gloves and wipe it on something and later it turns up in 10 their urine. 11 We know this because we monitor people carefully 12 and if they are not well trained they tend to do that. They 13 don't have the training so that they follow prescribed 14 procedures in handling this material, but I really think () 15 that the I- 131 in the high doses is a real hazard to 16 personnel and to the public if it is not done properly, and 17 it's not easy, it's not intuitive to do it properly. 18 We are getting into more and more complex 19 therapies with unsealed sources and I really think we need 20 more than the straw man that is up here. / 21 As far as .100 and .200, I mean those are 22 different issues. We haven't heard from all the 23 professional societies as we did this morning on those 24 issues. 25 The ACR does have a statement in here which hasn't
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199 1 been read. Dr. Holder did speak but we haven't read that 2 statement and they have very specific recommendations in 3 here. 4 The ACNP has made recommendations. I don't know 5 if you have received them, but they said for .100 adC .200 6 stick to the existing requirements for training and 7 experience, which are ten times the levels that you have up 8 there on the board. 9 The levels that exist right now are ten times the 10 120 hours that are on the board, and how can you go in one 11 day from 1200 hours to 120 hours, overnight? 12 You know, I fail to see that that makes any sense 13 at all. ! 14 CHAIRMAN STITT: Cathy? () 15 16 MS. HANEY: looked at the current requirements. I'll tell you how we got there. We ; With the assistance of 17 Barry Siegel we went through a residency program and we 18 looked at how many hours in that residency program were 19 specific to radiation safety. We assumed that NRC should ; 20 only be involved with radiation safety and not in the l 21 clinical practice of medicine, and the drop in the hours. I 22 DR. FLYNN: You didn't look at a radiation 23 oncology program. You can't separate out the radiation 24 physics and the radiation biology training from, you know, 25' time, distance, and shielding and inverse square law. You i i O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l l Washington, D.C. 20005 (202) 842-0034
200 1 can't separate out those issues. It's all part of safety
.e (3
i 2 training. 3 MR. GRAHAM: That's why we amended those training 4 regs this morning. 5 DR. KANG: Right. 6 MR. GRAHAM: You made a compelling case for 7 radiation oncology. 8 CHAIRMAN STITT: And now we're stuck trying to 9 make a case for these first three. I mean, I think we could 10 be here for decades discussing this, and I'm not -- 11 DR. NELP: I have a solution. 12 CHAIRMAN STITT: What? 13 DR. NELP: I have a solution. 14 CHAIRMAN STITT: I'll bet you do. Remember, we've ( 15 got -- ( 16 DR. NELP: So, a' simple solution is if you deal 17 beyond radiation safety is just require more experience than 18 five cases of hyperthyroidism or five or ten cases of 19 thyroid cancer. Require supervised experience with 25 cases 20 of strontium therapy or 25 cases of thyroid cancer. And 21 then to get that experience you will have to be in an 22 environment that's, you know, with the program and with the 23 practice of medicine. And that's what you're talking about. 24 The safety issues I think are not overwhelming, whether 25 you're given 400 millicuries or 100. I think they're -- you (~T IdR1 RILEY & ASSOCIATES, LTD. (') Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
201 1 follow the same rules. 2 DR. FLYNN: If you give a diagnostic dose of 3 technetium, what -- can you think of any instances where 4 significant harm would come to the patient by giving the 5 wrong patient the diagnostic dose? 6 DR. NELP: No , absolutely not. 7 DR. FLYNN: Then how can you have the experience 8 and training in 35- 200 the same as 35- 300 when you'can 9 kill a patient if you give a strontium therapeutic dose to ' 10 the wrong patient? 11 DR. NELP: Because I am a licensed physician who 12 has privileges to do certain things, and I have followed my 13 voluntary accreditation. I can't possibly purchase the 14 material and give it unless I show these people or the () 15 16 people in my domain that I'm qualified, regardless of what the NRC says. I 17 DR. FLYNN: Then when you give technetium for 18 imaging, why do you need to know as much detail about the 19 adverse effects of let's say 35- 300 materials which -- you 20 don't have to know about bone marrow suppression if you just 21 give technetium for imaging. You don't have to know about 22- all the other side effects, life- threatening side effects, 23- but you've still required the same number of hours in the 24 straw man language and then if you -- it's sort of like -- 25 DR. NELP: Because -- t ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 1 1
202 1 DR. FLYNN: It's inconsistent. The tape was 2 inconsistent. {~' 3 DR. NELP: We're talking about the practice of 4 medicine. I have to -- if I give chemotherapy, I run into ; 5 the same and even more devastating complications, and l 6 they're not regulated. 7 CHAIRMAN STITT: I'm going to turn your , 8 microphones off and tell you where we are right now. 9 I don't think we can solve this here. I don't 10 think we have the time, and I don't even think we have the 11 information. We have a motion that's before us, and it is l l 12 to accept what we see in front of us for 100, 200, and 300. ! 13 So we can vote that up, we can vote that down. i 14 If we vote in favor, that means we like what we've [ 15 seen in front of us. If we vote it down, I think it implies 16 we don't like it, but it does not necessarily suggest that l 17 we have the solution for it. But it does make some sort of ) 18 a statement coming from the ACMUI. Part of that statement 19 is that a lot more work needs to be put into it or at least 20 put in front of those bodies that need to be consulted. 21 So I'm going to say that I don't believe from our ! 22 discussions that we are heading in a direction where we're 23 having a resolution, so I'm going to call for the vote, and 24 then I think I'm going to stop the discussions. We don't > 25 have enough time to put this in order. So again understand i p, ANN RILEY & ASSOCIATES, LTD. Q Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
203 1 the implications. If you vote in favor of the amendment it 2 is you like what you see in front of you. 3 Granted we're lumping one and two and three 4 together, and if there's a part of that that you don't like, l 5 then you have to vote against the whole thing. The motion 6 is with all of them together right now. 7 DR. NELP: I have a question. 8 CHAIRMAN STITT: It depends on which part of the 9 agenda you want to talk about today and which part you're 10 willing to sacrifice completely. At this point we should 11 have finished 2- 1/2 hours ago. 12 DR. NELP: I was asking about the motion. The 13 motion doesn't mean we accept it verbatim. 14 MR. GRAHAM: No, the motion would not prohibit () 15 16 later discussion of the detailed language. DR. NELP: Or some detailed issue. 17 CHAIRMAN STITT: I need an amendment here. Can I 18 suck somebody into an amendment? I know that -- 19 MR. GRAHAM: I think what you're looking for and I 20 think I can amend my own motion. 21 CHAIRMAN STITT: Would you please? You know what 22 I'm looking for. 23 MR. GRAHAM: We would have separate votes. 24 CHAIRMAN STITT: Yes. So we can at least give the 25 staff some direction. []
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204 1 MR. GRAHAM: I'm pulling my original motion off 2 the floor and I'm recommending that the ACMUI is { 3 recommending the acceptance of straw man language or 4 training for a 35- 100. 5 DR. NELP: Second. 6 CHAIRMAN STITT: All right. Those in favor of-7 accepting the 35- 100 as it is. 8 Those opposed? 9 [The Motion to Adopt Straw Man Language for 10 Training and Experience on 35- 100 was passed 9 to 0.] 11 CHAIRMAN STITT: Any other motions? 12 MR. GRAHAM: I move that the ACMUI recommends the 13 acceptance of straw man langeace regarding training for 14 35- 200. () 15 16 DR. NELP: Second. CHAIRMAN STITT: Those'in favor of accepting 35.2 17 raise your hand. 1 18 [The Motion to Adopt Straw Man Language for ; i 19- Training and Experience on 35- 200 was passed 9 to 0.] ! 20 CHAIRMAN STITT: Okay. 'Are you willing to go at 21 another one? l 22 MR. GRAHAM: 'No. 23 CHAIRMAN STITT: At least we were telling 24 something to the NRC staff. 25 MR. GRAHAM: I move that the ACMUI recommend O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
205 s 1 acceptance of the straw man language for training related to g"3 2 35- 300. V 3 DR. NELP: Second. 4 CHAIRMAN STITT: All right. 5 Those in favor of accepting straw man for 35.3 6 raise your hands. 7 Those opposed. 8 [The Motion to Adopt Straw Man Language for 9 Training and Experience on 35- 300 was defeated 4 to 5.] 10 CHAIRMAN STITT: All right. We did something. 11 Time out. 12 See those little boxes at the bottom. We're not 13 done with the slides. So far we're only -- have had one 14 slide and that's it today. RSO -- which is the RSO -- okay,
/"N 15 we're going to do the --
L) 16 MS. HANEY: Authorized nuclear pharmacist. 17 Oh, Dennis? 18 MR. SWANSON: I actually went out after the task 19 force meeting and polled the nuclear pharmacy community as 20 to what they felt was an appropriate number of training and 21 experience hours. Although the responses back were pretty 22 much all over the board, I think the consensus is to leave 23 it at 700 hours. 24 And the reason for that, just so you understand 25 where we're coming from, is if you look at our board rs ANN RILEY & ASSOCIATES, LTD. [ () Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
206 1 certification ~ program, it is not an entry-2 level board certification program. Rather, it' recognizes a 3 specialty practice in nuclear pharmacy. In other words, 4 when I'm'a board- certified. nuclear pharmacist, it 5 recognizes that I'm a specialist in this area. It certainly 6 'would not.want to adopt our board requirements as 7 entry' level requirements, because we would fundamentally 8 have to have two years of. experience, et cetera. 9 As a result, we currently have no voluntary 10 standards that address what'would be appropriate training 11 and experience for entry- level nuclear pharmacists. 12 Therefore, it's felt that there's a need to in this case 13 since we don't have those voluntary standards in place 14 nationwide that we would continue with the 700 hours of () 15 16 training and experience which most people felt was appropriate entry- level requirements. 17 CHAIRMAN STITT: So that was discussion. Let's 18 have a motion. 19 MR. SWANSON: So I move that we leave it the way-20 it is. 21 CHAIRMAN STITT: Let's have a second. 22 DR. NELP: Second. 23 MS. HANEY: In the straw man. 24 MR. SWANSON: In the straw man. 25 MS. HANEY: Straw man says the 700 hours. ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
l 207 1 MR. SWANSON: Seven hundred hours basically is not 2 changed from the previous requirements. 3 MS. HANEY: Other than we added the exam and 4 the -- you already had the preceptor form. So the only 5 addition was the exam. 6 ., MR. SWANSON: It was the exam. Correct. 7 CHAIRMAN STITT: All right. Those in favor of 8 leaving it as is plus the addition of the exam? 9 Those opposed? 10' [The motion passed 9 to 0.] 11 CHAIRMAN STITT: All right, next on the list. 12 Medical physicists. 13' We can start with a motion. We can start with 14 discussion.
'15- MS. HANEY: Page 29 and the rule 3551.
16 DR. WILLIAMSON: I move we accept the~ straw man 17 language. 18 'DR. NELP: Second.
- 19. CHAIRMAN STITT: Those in favor of accepting the 20' straw man version?
21 Those opposed? 22 All.right. 23 [The motion passed.9 to 0.] 24 MS. HANEY: RSO is 3550, which is on page 27. 25 CHAIRMAN STITT: Somebody want to make a motion? l ANN RILEY & ASSOCIATES, LTD. j
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208 1 Then we'll have some discussion. 2 Come on, John. 3 MR. GRAHAM: I move acceptance of the straw man i 4 language. I 5 MR. SWANSON: I second. 6 CHAIRMAN STITT: Discussion in radiation safety 7 officers? ! 1 8 MR. ZOON: I just might mention I don't really l 9 want to bog down the Committee, because I think we need to 10 move along. We had a meeting at the Health Physics Society 11 ' midyear, just recently, on this issue. I know the society 12 is very concerned about the language in here, and we'll be 13 addressing it in writing. I don't really want to get too 14 much into the specifics, other than there's a feeling that () 15 16 there ought to be some type of exam specifically stated in here.
)
17 I see a lack of parallelism in these three 18 alternatives. We can have a board- certified professional, 19 we can have someone who meets the training requirements of 20 (b) or (c), and that gets us all the way down to just 21 appointing basically an authorized user under the licenses, 22 an RSO, and that's a very inconsistent sort of presentation. 23 CHAIRMAN STITT: Any other comments? 24 MS. McBURNEY: I agree the authorized user is not 25 required to have as much radiation safety training as is -- i l-l
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209 1 as an RSO, so if the authorized user is designated as the (~N-s 2 RSO, then I would think that they would also need to meet 3 that radiation safety hours as well, if they were authorized 4 as an authorized user under the alternative route other than 5 board certification especially. 6 CHAIRMAN STITT: Any other comments? l 7 Naomi? 8 DR. ALAZRAKI: I guess there's a very practical 9 consideration here in a lot of very small hospitals which 10 may be in remote places. You need someone to have that 11 title of radiation safety officer, and you may only have a 12 physician who is an authorized user. And so that individual 13 becomes the radiation safety officer because there's no one 14 else. And they're not doing -- of course they're not doing () 15 16 radiation oncology. They're not doing big things. are doing some diagnostic testing. But they They may be doing some 17 low- level hyperthyroid therapy. Maybe they get into 18 something like strontium- 89, you know. But they need 19 someone. 20 CHAIRMAN STITT: Dan? 21 DR. FLYNN: Yes, that's the point I was going to 22 make, and I think -- my understanding is when we did the 23 . briefing to the Commissioners that we need to focus on 24 high- risk activities and away from low- risk activities, 25 and there are some licensees which are huge with i ANN RILEY & ASSOCIATES, LTD. b Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
210 1 broad- scope licenses, and you have another small hospital 2 and a very remote hospital where.the minimum amount of 3 ' diagnostic level of technetium is being used as the only 4 isotope in the whole hospital. 5 To require something that the hospital cannot 6 provide in terms of experience and training, and no one 7 wants to go there to XYZ State in the middle of nowhere, 8 would be-not appropriate for the level of risk that's 9 involved at that institution with that licensee. I think 10 there would also be other federal law that you would have to 11 worry about, because I think way back when, when the QM rule 12 was being proposed, I saw these legal amendments at the end 13 of the rule whereby the NRC had to show what the impact was 14 on small licensees, the monetary impact on small licensees. () 15 16 So for you to require all these small hospitals in very small areas and very remote locations to pay the money 17 to send their people to get training for isotopes and for 18 levels of risk that they will never face would be a 19 -financial' burden, a serious financial burden on some of I 20 these small institutions. And I think the measure of risk 21 isn't compatible with what you're requiring them to do. 22 I think -- and it would be -- an institution will 23 always try to find the most qualified people in the 24 institution to be on the Radiation Safety Committee, in my l 25 experience, and the Safety Committee will be a reflection of l l ANN RILEY & ASSOCIATES, LTD. I Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
211 1 all the authorized users, in my experience, and that the 2 more risk that's involved in the use of isotopes will be 3 reflected by the more expertise that's available o'n the 4 committee, because you wouldn't have the authorized users 5 using those isotopes unless they had the experience and 6 training. 7 If you get into the therapeutic isotopes, you're 8 going to have people with therapy experience, and you're 9 going to have medical radiation physicists where you're not 10 going to have that in these very small hospitals. So I 11 think that you should keep that in mind when you decide 12- about who should be the RSO is going to be relative to who 13 the licensee is. 14 CHAIRMAN STITT: Jeffrey? () 15 16 DR. WILLIAMSON: Yes, we had considerable discussion of this at the February 12 and 13 subcommittee 17 meeting, and two ameliorating factors were pointed out, and 18 I raised the question what if someone who's an authorized 19 user under these minimal training requirements winds up -- 20 could such an authorized user wind up being the radiation 21 safety officer of a very complex organization? I mean, a 22 mini- broad scope licensee or something like that? 23 And it does say down here under part (c) that they 24 have to have experience in similar types of byproduct 25 material, and this could be used as leverage for the license i ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 j
212 1 reviewer to, you know, reject the institution's application ; I (~'g 2 for license with such an RSO. L.) 3 And I think that, you know, as things are 4 currently practiced, you know, board certification is 5 probably the most standard pathway to doing most of these 6 things, so we're not in this scenario where somebody with ! 7 just 40 hours of training winds up being an RSO. But, you 8 know, it's possible now under the new rules that that could 9 be , and it might not be inappropriate for this part (c) sort 10 of person to have some kind of an examination, maybe 200 11 hours of training. 12 MS. HANEY: There is an exam in there required for 13 this person. 14 DR. WILLIAMSON: There is? m 15 MS. HANEY: It's -- (} 16 DR. WILLIAMSON: Where? 17 MS. HANEY: The last two lines of the page, on 18 page 27, number 3. 19 MS. McBURNEY: That's not for an authorized user. 20 MR. GRAHAM: Then it gets into or. It's or 21 paragraph C, is it not? 22 DR. WILLIAMSON: C, I think is stand- alone, and 23 that's the concern. 24 MS. HANEY: No , it's - - well, if it is, we have i 25 still got to tweak the rule text here. But it is under the ANN RILEY & ASSOCIATES, LTD. O) (, Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034
213 1 alternative, what we have referred to as the alternative l fs 2 path is the structured education program, which is the 200
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3 hours, the preceptor form, and an exam. 4 DR. WILLIAMSON: Right. But what about No. C. Be S an authorized user, authorized medical physicist. 6 MS. HANEY: Oh, I see. So you are saying have the 7 authorized user take an exam? 8 DR. WILLIAMSON: Exactly. I am concerned about 9 the 40 hour training authorized user becoming an RSO. I 10 think that is probably what your concerns - - 11 MS. HANEY: But he could only become an authorized 12 user for a facility using 35.100 materials. 13 DR. WILLIAMSON: But do you still think that such 14 a person is going to be maybe in good position to be able to (} 15 maintain license compliance and do all the things that a 16 radiation safety officer should? 17 MS. HANEY: Well, he would have already taken an 18 examination to become - - a radiation safety exam to become 19 the authorized user for the 35.100 license. So he has 20 already gotten one radiation safety exam. And since he 21 would only be dealing with radiation safety for - - 22 associated with hazards of the material under 35.100, I 23 would think that exam would suffice for him, for us to feel 24 comfortable that he had a good enough knowledge of radiation 25 safety issues. r'N ANN RILEY & ASSOCIATES, LTD.
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214 1 CHAIRMAN STITT: John, did you have something you '(
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2 were trying to say? 3 MR. GRAHAM: No , I just wanted to clarify, that 4 was the discussion in the other subcommittee meeting, that 5 there was a clear understanding the authorized user would 6 have to take a radiation-safety examination, through the 7 . requirements in the definition in the strawman guide for an 8 authorized user, which tie it back to 35.290. 9 CHAIRMAN STITT: Any other comments? I'll call 10 for the vote. Anything else you just have to say, Dennis? 11 MR. SWANSON: Well, I just' wanted to clarify 12 because I think that any radiation safety officer is going 13 to have to be approved by the NRC as part of the license 14 application. () 15 MS. HANEY: Right. 16 MR. SWANSON: You are going to be reviewing the 17 qualifications relative to the program of any of these 18 individuals, right? 19 MS. HANEY: Right. Unlike unauthorized user could 20 potentially become an authorized user without us having 21 amended the license. 22 CHAIRMAN STITT: All right. Let's call for the
. 2 3. vote. Those in favor of Strawman as it appears for 24 Radiation Safety Officer, raise their hands. Counting and 25 those were - -
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215 ' 1 MS. HANEY: Nine in favor. / 2 CHAIRMAN STITT: Those who are not in favor? k)g 3 [Strawman Radiation Safety Officer Language 4 approved 9 to 0.)
- 5. CHAIRMAN STITT: All right. We have completed i
6 that list. We have not completed the morning's work. We 7 are going to figure out where we are going next. 8 We are going to shuffle. We are going to, 9 hopefully, get the definitive information about 10 Strontium-90, eye applicator calibration. We discuss this 11 about every time we have a meeting. 12 Dennis is - - you know, an unpleasant look. i 13 First, we are going to take a break, and then we have asked 14 a guest from NIST to come talk to us, and we will resume 15 after he get his presentation set up. (
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16 We still have not discussed cardiovascular uses 17 which are the innovative programs. We have not discussed 18 patient notification and reportable events, all of which 19 were from this morning, so we will get that done, if not 20 today, definitely tomorrow. 21 So, quarter after, be back. 22 [ Recess.] 23 CHAIRMAN STITT: All right. I am going to tell 24 your our plans. We are going to hear from our NIST l 25 presenter. Robert Ayres will introduce that talk. Then, on "g ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
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216 1 the second page of your agenda for today, we have at least
/~' 2 two SRMs that will take a short period of time. And then I L.)g 3 Dr. Paperiello is back in our meeting. We would like to 4 discuss reportable events, medical events and precursors.
5 So that will be the rest of the afternoon. 6 Go ahead, Robert. 7 MR. AYRES: Thank you. Hopefully, my voice will 8 stay with me. A way of starting out, tie in all to this 9 morning, this coming here with you at the Strontium- 90 eye 10 applicators is a perfect example of a single organ therapy 11 procedure with limited training and experience requirements, 12 and we are back again. 13 We last discussed this with the Committee - - we 14 were here talking to some of you in November of '93 about () 15 16 this, where we had a number of misadministration that were largely related to calibration problems which were either 17 vendor supplied, licensee performed or related to incorrect 18 use of radioactive decay of the sources. And at that time, 19 you agreed that the dose administrations were inaccurate for 20 a variety of reasons. 21 We acknowledged a problem in measuring delivered 22 doses and acknowledged that the QM rule at that time did not j 23 require that the doses be measured. We talked about the 24 NIST data on inaccurate calibrations and the non- homogenous 25 distribution of activity across the device surface, and what ; i
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'l you recommend is we issue an information notice alerting the 2 users to these problems about the device calibration and
- 3 cautioning them about --
that their technique may require ' l 4 a change, once they have made a change from one applicator 5 to another. 6 What we did then is issue an information notice 7 March lith, '94 following.your advice and asking them to I 8 submit a Quality Management plan, program for Strontium- 90 9 eye applicators. Also, we informed the users of the 10 information regarding the use and calibration of these 11 devices. 12 Since then, we have had a number of other, and 13 I'll present those in a second, misadministration with 14 these devices. So in December of '96, we issued another () 15 16 information notice to alert users of these recent misadministration that where, again, root cause for these l 17 were device calibration errors, and we reminded the i i 18 licensees that the Quality Management plan requires ensuring i 19 that the prescribed dose equals the administered dose, and 20 we discussed the decay correction and went further in 21 presenting the decay formula and a complete table to be used l 22 for decaying these devices. 23 Since our original discussions with you in 24 November of '94, we have had ten separate reports of 25 ' misadministration. There's been hundreds of patients ANN RILEY & ASSOCIATES, LTD.
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218 1 involved in these misadministration events, a significant i 2 fraction of them in a single - - or a combined single 3 source. Over 50 patients received doses twice that of the I 4 intended or planned dose, and in one case, the NRC medical 5 consultant recommended continued patient follow- up due to 6 potential for adverse health effects in the patients. And 7 on one other where we have had the significant overdose, we 8 haven't yet received the medical consultant's report on that 9 incident. 10 And what I would like to do, I'll put this up here 11 for a second, just allow you to glance at it, some possible 12 recommendations options. But before we get into that, I 13 want to mention a couple of things. One, basically, the 14 Committee and the discussion resolved around the fact that () 15 16 these - - that the protocol used in treating patients with the Strontium- 90 eye applicators was to treat to effect. 17 Well, what we are seeing is not directly related. 18 I think you are right in the first order in that they treat I 19 the effect, but they develop that in terms of some dose as I 20 part of their training. So, an ophthalmologist using these 21 devices learns that at a thousand rads times three fractions 22 is what gets the job done. And, therefore, from that point 23 on , that's what they use. And if a calibration error comes l [ 24 into the system, either through the change of the 25 applicator, through decay correction errors or through a I O ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034
219 1 subsequent miscalibration of the device, then that error 2 just stays right in the system undetected. ()g
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3 So they may treat to effect or learn it to start 4 with it, but they actually use dose numbers, or what they 5 believe to be correct dose numbers from that point forward. 6 But - - I am going to take this off and we will 7 come back to it. What I would like to now is bring Dr. 8 Chris Soares up from the National Institute of Standards and 9 Technology, who is really the national expert on the 10 calibration of these devices and the associated problems 11 with their calibrations and ask him to fill you in on that 12 background. Chris. 13 MR. SOARES: We'll probably need some lights down. 14 It's a little bit dark. [h v/ 15 I want to thank the committee for inviting me here 16 to address them about this subject, which is particularly 17 close to my heart. 18 There's kind of a long history to this field, in 19 no small part due to the long half life of the isotope. As 20 you can see, I've tried to outline what I think are some of 21 the major points; the invention of the extrapolation 22 chamber, the - - can't even see my own slides; the first 23 general use of beta ray applicators reported in 1947; the 24 first foil sources being produced in 1952 by Amersham; and I 25 most of the sources that are still out there are foil- based l ) i I (} ( ,y ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 i Washington, D.C. 20005 j
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220 1 sources; Loevinger's benchmark paper on the use of the < / 2 extrapolation chamber for calibrating eye applicators; the 3 establishment of our calibration by Jack Hood and Bob 4 Loevinger in 1976, which went along fine for about a decade 5 until someone noticed that there was a pretty serious 6 discrepancy between what we were getting for an eye 7 applicator and what Amersham was reporting for one of 8 theirs. This set about a long and painful reevaluation of 9 our calibration service which unfortunately dropped on me. 10 This was just when I took over that calibration that I was 11 faced with this. After a couple of years we reestablished 12 the calibration service in a revised form, and since then I 13 have been gratified that another calibration service has 14 been started at the University of Wisconsin by Leonard De I) V 15 Werd. We now have international comparisons in the works 16 with several European countries, and also there's work 17 actively going on right now to establish national standards 18 at both NPL and PTB. l 19 In the course of looking at eye applicators over 20 the years, I have identified approximately eight 21 manufacturers, and this table sort of shows, as near as I 22 can tell, when they were producing applicators. The Tracer 23 Lab sources, most of the sources out there are Tracer Lab, 24 they sold their company to ICN in 1969, and ICN continued to 25 market the sources. Lank Research Corporation made the f CN ANN RILEY & ASSOCIATES, LTD. ! k ,) m Court Reporters i 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
221 1 first ceramic- based sources - - I'll get into difference a ( (_s 2 little later. They sold their operation to Adam Chem, again j 3 in about 1969, and I believe that then went on to New l 4 England Nuclear. There's a very close similarity between i 5 New England Nuclear sources and Adam Chem sources. 6 Amersham has been making the sources since the 7 1950s and continues to make them. In fact, they are the < l 8 only manufacturer still making sources. l 9 3- M has made sources. IPL made sources which 10 were marketed by Nuclear Associates, and then two rather 11 obscure source manufacturers, Tech Ops and Manning. 12 This is a breakdown of all the sources that have 13 come through NIST since 1975, approximately, and I think 14 these percentages on the right are fairly accurate as to
, 15 what percentage of sources are out there, who is making what 16 sources. There's been a jump in Amersham, of course, since 17 the paper which first described this data appeared in 1995, 18 mainly because they are the only ones still making them, so 19 I'm getting new sources from them occasionally. But I think l
20 these are fairly reasonable numbers, and the bottom line is 21 that Tracer Lab has the lion's share of the market. 22 These are some source characteristics. I probably 23 won't go through these very much, just to let you know they l 24 are approximately a centimeter in diameter, of somewhat 25 smaller active diameter. There are two main types that I l r~ ANN RILEY & ASSOCIATES, LTD. ( ,}/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 L______________--___ _ _ - - -- - _ - -- . - - _ - - - - -- -
2?.2 1 have been able to identify. The ceramic foils - - I'm ) s 2 sorry, the electroplated foils, which were first introduced 3 by Amersham, in which the radioactive material is
]
4 electrodeposited on a carrier such as silver, is usually 5 used, and then there's the ceramic sources, in which a 6 porous ceramic is immersed in a fluid of known specific 7 activity that the radioactivity is taken up within ceramic, I 8 the ceramic is then fired to seal the material in, and then 9 encapsulated. 10 The calibration methods have been varied over the 11 years. Extrapolation chambers are the preferred method. 12 3- M commissioned someone to do TLD measurements. Several 13 of the manufacturers had sources calibrated at NIST, and 14 then they transferred those calibrations to other sources. j 15 The interesting thing is some of the older 16 calibrations were calibrated in terms of a unit called the 17 REB, the rank and equivalent beta, and when I first got into 18 this, it was a little bit - - I wanted to try and compare 19 calibrations of manufacturers to our calibrations, and I had 20 to come up with some sort of modern conversion for the REB, 21 and this is my analysis in which it ended up being that a 22 rad was very, very close indeed to a REB, and this was just 23 because of a matter of accidents between changes of 24 constants over the years, and also the application of !, 25 stopping power ratios. But it ends up being fairly close to i l p) (, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W , Suite 300 Washington, D.C. 20005 (202) 842-0034 4 l t l .
223 1 unity.
/ 2 Now when we do the calibrating eye applicator is V) 3 we get an applicator, it goes through an acceptance 4 procedure, things such as wipe testing, physical observation 5 o* the - - condition of the applicator. We make a 6 determination of where the outer source of the source is, 7 the outer diameter of the source in relative to where the 8 active diameter is, and this is part of the report that's 9 generated. And, of course, we set the thing up in the 10 extrapolation chamber, and then we do a measurement where we 11 determine where the center of the source is, and we do by 12 that scanning across the source surface with a one 13 millimeter diameter collecting electrode. It's the same 14 problem we have in all measurements with small sources.
() 15 16 First of all, we spend most of our time setting the source up, relatively little time making the 17 measurement; and second of all, the conversion of 18 detector- based coordinant system into a source- based 19 coordinant system, this is a very important thing. 20 Then we do an extrapolation chamber measurement on 21 the properly- centered source, using a four millimeter 22 diameter electrode, and this is another kind of arbitrary 23 thing that we have come up, where we want to average the 24 dose over the central four millimeter diameter of the 25 source, and this leads to some problems for non- uniform l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
224 1 sources, as I'll show you later. 2_ And then the last step is simply a measuring
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3 assurance of radiations with radio- chromic film, just to 4 verify that something wasn't strange with the eye 5 applicator,.or with the extrapolation chamber. 6 The University of Wisconsin has a calibration 7 service in which they essentially juut do the last step on 8 this, they just make measurements with radio- chromic film. 9 Now the film that we used for this is a seven 10 micron thick. It's the oldest and least sensitive of the 11 GAF Chromic systems. It's on a 94 micron base material, and 12 we read this out with high resolution scanning densitometry. 13 It uses a 100 micron diameter spot, and we can step in as 14 cmall as 40 micron increments. So it's extremely high () 15 16 resolution, we get a lot of data from a single small piece of film. 17 In fact, this is what the films look like for a 18 - - this is not a typical eye applicator, this is New I 19 England Nuclear eye applicator that we use to calibrate 20 films, and you can see there is a very uniform dose 21 distribution, and that you get a - - it's not oval, either, 22 that's an aspect / ratio problem. It's fairly linear with 23 dose and you can see that it turns a nice blue. This film l l 24 is great, you don't have to do any processing, it just turns 25 color all by itself in the process of-irradiation. That's ANN RILEY & ASSOCIATES, LTD. k'O s_/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
225 1 practically the only good news associated with this film. 2 It has a fairly complicated absorbence structure. 3 There's a major peak at about 660 nanometers, and a minor 4 absorbence peak at about 610. We read this out with a 5 helium neon laser which has a wavelength of about 633. So 6 you can see we are kind of on the' shoulder of the absorbence 7 curve when we do that. 8 And you also notice from this that there is a 9 small shift toward lower wavelengths in the absorbence 10 spectrum as you increase in dose. And not only is that the 11 case, but there's also a small shift with temperature during 12 storage, and possibly shifts due to other factors as well. 13 And so there's lots of pitfalls that one can fall into in 14 the use of this film, and one has to be very, very careful () 15 16 when using it for absolute dosimetry. relative dose distributions, it's pretty good. But for mapping 17 This is a calibration curve summary of some 18 measurements I've made over the years with one particular 19 batch, and you can see it's relatively linear, up to about 20 300 gray, and it's characteristic of the densitometer system 21- that we used, that the data kind of gets more noisy as you 22 get up into the higher dose levels. And, of course, it's 23 noisy at the low dose levels because of not very much 24 signal. So there's actually a minimum in the standard 25 deviation as a function of absorbed dose at about between ANN RILEY & ASSOCIATES, LTD. (~N ( ,) Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
226 1 100 and 200 gray, and so that's a nice place to use this 4 (~ 2 film. 3 This is a summary of the calibration comparisons 4 that I made for a paper that was published in Medical 5 Physics in 1995, and there's - - I didn't really come 6 prepared particularly to talk about this because I thought 7 it was all fairly common knowledge. I think you may all 8 have copies of this, even. But the interesting thing, I 9 think, is the last column which is the standard deviation of 10 the differences between the NIST calibrations and the 11 manufacturer calibrations, and anything under 5 percent, I 1 12 think, is excellent. 13 Now I am not terribly concerned with something 14 like Amersham, which shows an average difference of 23 I () 15 16 percent with a standard deviation of only 4 percent. And the reason for that is that about half of that or more than 17 half of that difference can be explained in terms of just ; 18 the differences in the factors that are used to get the 19 extrapolation chamber number converted to dose. And you can 20 see from this table that about 13 percent of that 22 percent 21 difference is due to these different factors. 22 So we feel that at this point we are in pretty 23 fair agreement with what Amersham is doing. l 24 The thing that I really came prepared to talk i 25 about is this nonuniformity problem, and this is data also I N ANN RILEY & ASSOCIATES, LTD. ' s' Court Reporters 1250 I Street, N.W., Suita 300 Washington, D.C. 20005 (202) 842-0034
227 > 1 from.that same paper which shows a couple of representative
/ 2 sources from each of the eight types that we have looked at. !
3 And actually the patterns that are shown here are fairly 4 consistent, and I can almost predict when I get a source in 5 from a given manufacturer what it is probably going to look 6 like. 7 What you see here are 10 percent isodose contours 8 starting at the 90 percent contour down to, I think, either 9 20 or 10, I have forgotten how far it went down. And as 10 with any contour map, if you want a flat uniform source, 11 then you want to look for a source that has a lot of contour 12- lines shoved together at the edge. Anything else is going 13 to exhibit some nonuniformity, and the extreme example is 14 the second source shown in Manning Research column, and 15 that's what I am going to spend the rest of the time with. 16 Oh, I've got to show you some close- ups of these 1 17 since you probably couldn't see them very well. 18 This also shows the scale of these. Tracer Lab 19 sources are interesting. They had probably the largest 20 physical diameter of any of the sources; they were about 12 21 or 13 millimeters in diameter, but the sources themselves 22 were fairly small. It could be very small; they are some of 23 the smallest ones I saw. 24 There are also foil- based sources and it's 25 characteristic also of foil- based sources that they don't , f l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 l
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228 1 have sharp edges, just dosimetrically they tend to fall off l ("T
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2 gradually from the center. This causes problems.
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3 Amersham is, of course, the archetype of the foil i 4 sources and looks somewhat similar. 5 New England Nuclear, on the other hand, with an 6 example of a ceramic source, very flat source - - in fact, 7 that's what I showed examples of earlier in the calibration 8 series. This is the kind of source I love. It's - - the 9 number you get out of it from the extrapolation chamber is 10 fairly independent of where the collecting electrode is on 11 the surface of the cource. It gives you a nice - - the 12 0121 is very similar to the one that I showed you for the 13 calibrations. 14 ARC sources generally were pretty good. That
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[Y 15 number 183 was kind of an oddball one, not typical of the 16 general run of the mill. And they were the first ones, I ' 17 believe, to use ceramic- based sources. 18 IPL sources, I believe, were for the most part j 19 ceramic. They looked pretty good. 20 I should mention that the jaggedy lines that you 21 see on 903 were a problem with the densitometer that with a 22 certain step size that we use, we get these strange 23 features. 24 3- M sources are interesting in that they almost 25 invariably have a peak off- center which makes for some i l
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1 229 1 interesting results if you are using a Castro- Viello mask 2 to mask out part of the field. The number you will deliver
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i 3 will then be a function of the orientation of the mask over 4 the source, which is not a good thing. 5 Tech op sources tended not to be terribly uniform. 6 I don't think they made all that many.
-7 And finally, my favorite, our Manning Research ,
t 8 sources, in particular this number 548 which I am going to 9 spend a little more time with. You see it has a fairly 10 involved structure. In fact, in this - - this is the one 11- where I actually show the isodose contours. And what is 12 also shown on here is this dashed line near the center of I 13 the-source, and this is the position of the four millimeter 14 diameter collecting electrode when this source was () 15 16 calibrated. And you can see it does not encompass the hot spots that are toward the edge of the source. And so the i 17 number that I reported from this source is then considerably 18 less than what the peak dose rate that this source was 19 delivering. 20 A little more dramatically, you can see that the 21 white circle in the bottom indicates again where the 22 collecting electrode was, and then there's a 3- D contour of 23 what the dose profile would look like at the surface of the 24 source. And you can see the' peak dose rates from the source 25 is 200 milligrade per second, whereas the calibrated reading
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230 1 that I reported to.the customer was 170. 2 So just the very use of this source with the () ~
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3 standard best estimate of the calibrated dose rate would 4' lead to a misadministration. 'And this is the kind of thing 5 that I think we really ought to look at and not have these 6 sources around. 7 Now there are several organizations that are 8 engaged in generating reports and also intercomparisons. 9 I'm involved with all these groups. The ICRU has a report 10 committee working on medical applications of beta rays, and 11 in the works right now is an intercomparison of surface dose 12 rate from strontium 90, both planar and concave applicators. 13 Retinium irradium eye applications are used 14 considerably in Europe to treat ocular melanoma, something I\ 15 which in this country is done mainly with I- 125 placques. G 16 APM has a couple task groups, one on film i 17 dosimetry, in which some comparisons with densitometry have 18 been performed, but mainly TG- 60, which is involved with 19 standards for intervascular brachytherapy. No 20 intercomparisons have been done to date with that, but this i 21 is something again I am very interested in. 22 To my way of thinking, the planar sources, the eye 23 applicator sources really are the basis for the dosimetry 24 surface and near contact dosimetry that we are doing with 25 intervascular brachytherapy sources, particularly beta I e ANN RILEY & ASSOCIATES, LTD. O,s Court Reporters l 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 L (202) 842-0034 i t.'
231 l 1 sources, and so we really need to understand this dosimetry j 1 2 before we can really do good dosimetry on these seed 1 l {/} ~- 3 sources. 4 Finally, the European community is funding a low 5 penetrating radiation surface dose measurement project. 6 There's an extrapolation chamber measurement survey in 7 progress, and then we have a strontium- 90 surface dose rate 1 8 measurement planned. This will be run by NPL once they get 9 their standard together. l 10 I skipped some slides. Okay. I 11 There's a couple of uniformity recommendations 12 that have come out. The APM Task Group 60 has indicated 13 that it would be desirable for at least seed and line 14 sources to have 10 percent uniformity, plus or minus 10 () 15 percent uniformity over the central two- thirds of the 16 treated length, both parallel to the source axis and 17 perpendicular to the source axis, this to be determined at a 18 two millimeter depth. 19 The ICRU group that I'm working on has indicated 20 that it would be desirable to have a - - and this is a , 1 21 complicated one, and I don't think we have considered it l 22 real well yet, but what they are saying is that it should be j 23 plus or minus 10 percent over a radius which is 8.8 times ; 24 the 50 percent isodose contour radius, and this is 25 determined at 1 millimeter depth. And this is complicated
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232 1 'enough I. felt like-I needed.to draw a little picture. . And 2 so what I have-shown here are two eye applicators, and now 3 we are plotting dose rate as a function of distance from the 4 center of the source. 5 So a source like the New England Nuclear source 6 that I showed you earlier is drawn in green, fairly sharp l 7 edge, and a source such as'the Manning Research, at least 8 along one radius which passed through that hot spot, would 9 look-like the curve drawn in red. And this is obviously a 10 source that not only gives rise to difficulties in 11 calibration, but it's just - - its whole calibration is 12 ambiguous. You don't really know what dose to assign to it. 13 And my solution to this was just not to have to deal with it 14 at all. l () 15 16 There has been a proposal to have all sources in use And so how do we go about culling these out? 17 calibrated at NIST or the University of Wisconsin; that's 18 one of the notes that was on Bob's list that we'll get back i 19 to. Something that I would like to see done, which I i l 20 proposed before, is to perform a mail film dosimetry i 1 l 21 radiation survey in which phantoms containing radiochromic 22 film would be mailed to licensees to be irradiated by the 1 23 licensee and returned to NIST. This may not give us much L 24 absolute dosimetry information, but it would definitely cull i 25 out the sources that have extreme irregularities on their O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 E_____-----_____ - _ _ - - - - _
233 1 surfaces. 2 So with that, I am going to cut this off and put 3 Bob's slide back up. 4 MR. AYRES: The only thing I was going to comment 5 is the full text of these recommendations are under the 6 strontium- 90 tab in your briefing folder. This is just a 7 summary of those. 8 I'll turn it back over to Madam Chairman now, I 9 think would be appropriate. 10 CHAIRMAN STITT: Are there comments of questions? 11 Gee, this really struck the interest. Go ahead. Let's go 12 down this line. Jeffrey? 13 DR. WILLIAMSON: Well, I.just had a question for 14 maybe both Dan and Chris. In the misadministration that Dan () 15 16 described in the analysis that's included here in our packet, evidently there was a 45 percent discrepancy between 17 the old NIST pre- 1988 calibration and the more current one 18 based on your formula meter diameter standard. Can you 19 explain why that was so, and what kind of applicator that 20 was? 21 MR. SOARES: I have forgotten the details of that, 22 unfortunately. The original calibration I did look up, and 23- as I recall, it was a fairly nonuniform source, and what was 24 done is the - - it was recalibrates at the University of 25 Wisconsin, and they came up with a 48 percent different l O ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034
234 1 number. 2 Now to understand fully what that difference is [ 3 due to, you would have to understand how the sources were 4 originally-calibrated at NIST, and what was done there was 5 that rather than having the collecting electrode define the 6 volume over which the ionization was measured, the 7 collecting electrode that was used was much larger than the 8 source, and some assumptions were made about the actual 9 volume of ionization that was occurring. And the assumption 10 that was made was that it could be adequately approximated 11 by determining the 50 percent isodose contour of the given 12 source. And the reason why that seemed to be an all- right 13 assumption was that the source that was used to make that 14 assumption was the New England Nuclear Source which had very () 15 sharp edges. And for that source then, the 50 percent 16 isodose contour very, very well approximated what the area 17 of ionization, the volume of ionization was. 18 However, for a source which is very nonuniform and 19 for a source that falls off with - - that falls off 20 gradually, if you take the 50 percent isodose contour, you l 21 will have a considerable amount of ionization occurring 22 outside of that volume, and so when you divide the measured 23 ionization, which is occurring over a fairly large volume by 24 the area that you assume that the ionization is occurring l 25 over, which is smaller than it actually is, you'll get a i O
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235 1- much larger number than what's actually occurring. 2' Now that's one possibility. Also there may have 3- been a hot spot in that source, and that could-be the rest 4 of it Like I'say, I've read-that material, but I haven't 5 looked at-it recently. Was it Tracer Lab? 6 DR. FLYNN: I don't remember the type of source it 7 was, actually. I think it might have been Tracer Lab, but I 8 think at least from what I had read, there'was an assumption 9 that there would be a hot spot, and that the different 10 calibration techniques would be that you were looking at a 11 smaller cross sectional area and they were looking at a 12 larger cross sectional area which included the hot spot in 13 the periphery. That was my understanding, but I'm not - - 14 I haven't -- I was relying on my. recollection of the 15 reports when they came in. (} 16 MR. SOARES: Yes. The original NIST calibration 17' made no effort to determine - - or made - - actually there 18 was an effort made to map the source, but it was at a very 19 coarse resolution, that 1 millimeter diameter, and I think
- 20. Jack Pruitt was even at one point early in the service 21 issuing traces of what the dose profile looked like across a 22 couple of axes of the source. But that got away from that 23 fairly quickly for some reason.
24 DR. FLYNN: There's also 14 years between the two 25 calibrations, and it could be that also the calibration l ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l _ - - _ - - _ _ _ _ - . - - - - _ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - _ - _ _ - - - - - - - . - - - - - - - - - - ---------------------------------------------]
236 1- techniques and the setups have changed somewhat in that 2 ' period of time. 3 MR. SOARES: Oh, yeah. Definitely. 4 DR. WILLIAMSON: Well, it was quite exceptional 5 because.the article included in the packet reports that the 6 general experience was the two calibrations agreed within 10 7 percent. 8 MR. SOARES: Those are some fairly nice sources. 9 Also, that was in 1990 that I wrote that article and 10 published it in 1991, and my experience at that point was 11 considerably more limited than it is now. 12 DR. WILLIAMSON: What would you say.now? q 13 MR. SOARES: It doesn't surprise me a bit. I 14 would not be surprised to see differences of 40, 50 percent,
/~h 15 for certain sources. Now if you told me the type of source, 16 then I could probably tell you, well, it probably won't be 17 too bad, something like a New England Nuclear, Atlantic 18 Research, even most Amersham sources probably only 20 or 30 19 percent.
20 CHAIRMAN STITT: Let's go ahead and go over here 21 to the left side. 22 MR. SWANSON: I have several questions, I think, 23 about where we go with this. 24 First of all.- - and you have kind of addressed 25 this - - are there particular manufactured sources or, I ANN RILEY & ASSOCIATES, LTD. (O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
237 l' refining that, are there particular manufactured sources 2 since a particular date that you would feel confident are 3 calibrated correctly? 4 MR. SOARES: I think I could say that, yeah. 5 MR. SWANSON: So if we did - - if we required 6 recalibration of sources, we wouldn't have to require 4 7 recalibration of all sources; we could eliminate those that 8 you felt generally are okay? 9 MR. SOARES: That would still probably include 10 over half. So now we are down to half the sources that are 11 out there. l
- 12. MR. SWANSON: What does it cost to calibrate a 13 source?
14 MR. SOARES: We charge I think about $1600, and i () 15 'I'm not sure what Wisconsin charges, but it's probably 16 considerably - - well, not considerably, but somewhat less. 17 DR. FLYNN: 1200. 18 MR. SOARES: Is it 1200? i 19 DR -. FLYNN: Yes. 20 MR. SWANSON: And assuming a source was so 21 nonuniform that you wouldn't recommend its use, what does a 22 new source cost? 23 MR. SOARESi That's a good one. A new source is 24 about $7000 if you can get them. It turns out that it's 25 very easy to get old sources. I put out the word on the ANN RILEY & ASSOCIATES, LTD.
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238 1 internet last year that I would be accepting old sources if 2 anyone had them to give me, give them away. I was soon (%./^) 3 swamped almost to the limit of our license with people that 4 wanted to give me these things. And so I took - - I took 5 about 10, I guess, 10 or 12, a fair sample of what was out 6 there. And it's not difficult to get new sources - - or to 7 get used sources, I should say. 8 MR. SWANSON: How many of those used sources were 9 actually pretty good? 10 MR. SOARES: Well, I tried to get about half of 11 them as good ones. My plan was to turn them around and give 12 them to other national laboratories, calibrated as reference 13 standards; also manufacturers, as sort of secondary 14 standards. 15 MR. SWANSON: But if we had people sending in
)
16 their sources and they weren't good, we could replace them 17 with sources that were given to you? 18 MR. SOARES: I think, yeah, it probably could be 19 done. We have a little bit of a problem with that at NIST I 20 because - - this is a very subtle point that was explained 21 to me - - it was not felt prudent that we would - - should 22 issue these things back for medical uses because it's not 23 covered by our - - kind of our purview, which is why I've i 24 tried to -- when I said that, I said that very carefully 1 25 about how we would be reusing the sources, I would be ' l l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 ' (202) 842-0034 l L__________________
239 1 sending them to manufacturers and standards laboratories as 2 secondary reference standards, not to be used as medical 3 devices. 4 So it's a little problem that we have with doing 5 what you said, but I'm sure if some third party could be 6 involved, then that would take us off the hook. 7 CHAIRMAN STITT: Other questions? Dennis? 8 Okay. 9 MR. ZOON: Chris, from your experience, what 10 percentage of the sources out there would probably fail the 11 acceptance criteria that you are proposing? 12 MR. SOARES: That's kind of a hard one because 13 I've never actually made that determination at 1 millimeter. 14 I do these things routinely in contact. At 1 millimeter, I (} 15 think it would tend to'do two things: 16 It would tend to both smooth out the wrinkles, to 17 some extent, but it also would make a flat source start to 18 hump over a little bit. You'd start to lose more at the 19 edges. So I'm not sure how those would compensate, but I 20 would say roughly, just seat of the pants, probably 20 21 percent would have a problem with that; as high as 20 22 percent. 23 CHAIRMAN STITT: Other comments over there? Jeff? 24 DR. WILLIAMSON: Well, I think it should be a 25 - . topic of some concern to us, the state that this form of l~ p ANN RILEY & ASSOCIATES, LTD. (_) Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
240 1 therapy is in, and it's a,.you know, a good example of where ("% 2 there hasn't been really very much standard- setting, or 1 i l 3 should I say development of industry standards or 4 encouragement to accept them by our community. And a good l 5 example of what happens when there aren't, you know, firm 1 6 expectations that users will calibrate their sources in ! i 7- terms of modern techniques, or at least make some effort to I 8 verify them. So I think it wouldn't be imprudent to require 9 or strongly encourage all or most users to seek out recent 10 calibrations if they are still performing this kind of 11 therapy. I think the 3 times 1000 does not have a lot of 12 meaning if there are users with large patient experiences 13 that have been treating with, you know, dose rates that - - i 14 relative to a fixed standard disagree with one another by 15 maybe a factor of two, and certainly, you know, there seem 16 to be at least two, perhaps, treatment traditions that make 17 sense, probably those associated with the old NIST standard 18 and those associated with Amersham, and it's knowing that 19 there was, what, originally approximately a 40 percent 1 20 disagreement? So, you know, there's really sort of two sets 21 of clinical experiences based on those dose numbers. And it 22 seems some reason to think that the dose given to patients 23 isn't irrelevant; you know, there are complications, there 24 are recurrences. 25 CHAIRMAN STITT: John, you have some comments? , i ANN RILEY & ASSOCIATES, LTD. O 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034 _ -___ _ - - _ _ _- _ J
241 1 MR. GRAHAM: . Well, it's more questions, I think, f i 2 on the other side of the room. 3 Having read this thing before the meetin', g there 4 were 14 events that were identified, 13 of which seemed to 5 be related to this strontium eye applicator? Is that right, 6 Bob? It came down to 14 examples total, 13 were related to 7- this? That's what is in the written narrative. f 8 MR, AYRES: Yes, that's correct. 9 MR. GRAHAM: So assuming that's true, at the time 10 it was discussed in '93, the ACMUI responded to the NRC that 11 the dose delivery was unlikely to be accurate, it was based 12 on the fact that even with the best technique, the 13 uncertainty in calibration is 12 percent, the physical 14 application procedure, the way the applicator is held in i 15 place, timing of the procedure may add another 10 to 20 w.) 16 percent uncertainty, the amount of tearing in the patient's 17 eye and the amount of topical anesthetic used. And then we 18 went on at that time to say that the ACMUI members advised 19 the Staff that calibration was not a critical factor in the 20 use of strontium- 90 eye applicators for treating - - how 21 do you say it? - - because licensees treat for response l 22 rather than to tolerance. Has that changed? I guess I l 23 asked, I understand this is still the only condition for 24 which this would be used. I assume all of those other 25 factors still apply, so what has changed? p ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
242 1 MR. AYRES: I think - - I mentioned I think the
/g 2 treating for response is done a little different way. It U 3 actually, as part of their training in the use of the 4 device, developed a-dose prescription formula that they use, 5 3 times 1000 centigrades, what- have- you, and that's used 6 through the rest of their practice. And if something 7 happens in the calibration of the source through either the 8 . change of source, one to another, or through poor decay 9 corrections or poor calibration or something, then they 11 0 continue to follow the same prescription, but it's no longer 11 the same.
12 So this is one area that we could address, and so 13 are proposing these, and what I was doing when you asked 14 questions - - I can't quite read at the bottom, but Dr. () 15~ 16 Soares proposed one additional recommendation which would be to do this dosimetric film survey. So I tacked that on the 17 bottom of my slide there. 18 CHAIRMAN STITT: Other comments, and then what 19 we'll be wanting to do is to look through the possible 20 options and see if we like one of those, discuss it, and 21 also answer the question should this go into the straw man 22 that we have been reviewing during this meeting. 23 So with those in mind, let's go ahead with some 24 more discussion. Dan? 25 DR. FLYNN: Okay. I have been actually at i l ANN RILEY & ASSOCIATES, LTD. Os Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
243 1 different regions of NRC, for whatever reason, I mean over 2 the period of the last five years, I have looked into a lot 3 of misadministration, probably nine for sure, maybe 10, 4 from most all of these. And some of them were trivial, 5 involving a timing error with a stop- watch, involving q i 6 leaving the cap on the strontium source and treating the ' 7 patient's eye with the cap on. But some of them involved 8 large numbers of patients, that the two kinds of errors that 9 concerned me the most would be those where the source was ! 10 not properly calibrated, such as the case in Puerto Rico, 11 where an ophthalmologist used a physicist who wasn't a i 12 radiation oncology physicist who calibrated the strontium- ' 13 source with a Victoreen R- chamber, and obviously the betas 14 are being absorbed in the cap of the chamber. And so () 15 16 hundreds - - I think probably if you looked at all the patients that were overradiated, it was in the hundred or 17 more patients were involved in that. Sometimes the dose was i 18 more than - - was double. 19 In Hawaii, the same instance, where a diagnostic 20 radiologist in Hawaii calculated what he thought was the l 21 half life, but did it himself, and patients were getting 22 double the dose. It was a number of patients in that 23 instance. i 24 And then most recently, another episode, a 25 . separate episode in Puerto Rico, which I just sent the I O ! ANN RILEY & ASSOCIATES, LTD. l Court Reporters I 1250 I Street, N.W., Suite 300
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244 1L report.in to Region II about two weeks ago, but involving 2 large numbers of patients. ; 3' Now here's what the problem is. The problem is 4 that at least talking to colleagues of mine in ophthalmology 5 and doing literature searches, I mean the two main things { 6 .they are looking at are lens effects, meaning cataracts, or 7 scleromalacia and secondary ocular infections which are 8 -rare. 9 Now here's where the problem is. The effects that 10 are seen can be very late, we're' talking five, 10 years. So 11 then when you ask the ophthalmologist, did you notice any 12 adverse effects of the patients you treated during the past 13 year, he oftentimes will say no adverse effects. And in the 14- Hawaii incident, the radiologist said no adverse effects, 15 but one of the ophthalmologists I talked to in Hawaii said 16 some of his patients did have some adverse effects. So it 17 depends who you talk to, and the question is do you wait 18 long enough to see these effects? Because if you have to 19 wait 10 years to see - - let's say you gave double the dose 20 to a hundred patients, maybe you'll see cataracts in 10, but 21 maybe five or six of those cataracts won't impair vision, so , 22 don't require surgery. So, therefore, you have to wait 10 i ! 1 23 years to see the adverse effects in five people. 24 Well, if you are one of those five people and you ! 25 are elderly and you may not be getting follow- up exams I i
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245 1 after 10 years and you are in a nursing home, I think that's 2 an adverse'effect that we should try to protect the patients 3 from. These patients aren't being followed by the 4 physicians, normally. 5 So when you look in the literature, you look at 6 the complication rates reported, there - - over the 7 spectrum, they are off, there are huge discrepancies in the 8- complication rate, you can't see a clear dose response curve 9 in the complication rate, and that's because if you read the 1 10 materials and methods of these papers that'are being 11 published, some are reporting complication rates on patients 12 they only treated a couple of years ago; some-of them are 13 actually actively' examining the eyes of the patients that 14 were treated - - they tend to be the papers written with 15
.( ophthalmology input --
and some are only reporting 16 complications if the patient brings it to their attention. 17 They are not following these patients, they are just 18 reporting problems as they might come up. So we don't have
~
19 a clear measure of the dose response. 20 However, there is other data, and it's in some of 21 our classic radiobiology textbooks, Hall Radiation Biology, 22 for example, one of the classic books we use in radiation , 23- oncology, that there is dose response data that is 24 published. The threshold for cataract production. In many 25 of these misadministration, the dose, surface dose is such l-l l ANN RILEY.& ASSOCIATES, LTD. f kT
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246 1 that the dose at depth, which in some papers is 2.5 b' "T' 2 3 millimeters, in some-papers it's 4 millimeters, is sufficient to produce cataracts. 4 But, again, if you have to wait five or 10 years, 5 you can't rely on the published data for that. When new 6 authorized users get these sources, what do they rely on to 7 decide as to what should be the written directive or 8 ' prescription? A new authorized user, let's say an 9 ophthalmologist, gets a source. He then has some literature 10 or'some textbook that he relies on, and some of these 11 published reports, including the one report from the 12 University of Minnesota by Dusenberry, who actually cites 13 that during the course of writing the paper, they discovered 14 that there was a 30 percent error in the calibration, and () 15 16 the author of the article attributed that complication, the unusually high complication rate as being possibly related 17 to the fact that their sources were miscalibrated and they 18 gave a higher dose than expected. 19 So, therefore, these new authorized users are 20 relying on medical reports to make judgments as to how to 21 treat patients, relying on medical reports, perhaps on 22 sources that may or may not be calibrated correctly. 23 So, for example, if I'm a new ophthalmologist and 24 I get a paper from XYZ University, and that source is giving 25_ a dose that's 30 percent too low, so the paper is written on O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, NW., Suite 300 l Washington, D.C. 20005 (202) 842-0034
247 1 doses which are 30 percent too low, and my source is
~
2 miscalibrated, and my source is actually giving 30 percent 3 too high, then I'm giving a much higher dose than I think 4 I'm giving when I'm treating the patient. 5 So I-guess my point was that calibration errors 6 and errors in decay calculations, which have been several, 7 that if we could somehow theoretically have all these 8 sources calibrated by one lab to including supplying decay 9 data, instead of giving ophthalmologists the homework 10 assignment of calculating radioactive decay and they make 11 mistakes, it doesn't cost anybody a single penny to, when 12 you print out the calibration data, to spit out a half, 30 13 years, or a half life's worth of data, four datapoints per 14 year. So that you don't even have to worry about the 15 correction chart that the NRC put in their information
)
16 notice. The decay, the calibration includes what the 17 surface dose rate is in centigrade per second for the whole 18 30 years. 19 So any time - - and then when the NRC inspectors 20 come around, or the state inspectors, they can ask if that 21 document, which should be about two pages in length, is 22 present. So, therefore, if the authorized user changes, he 23 can rely with assurance that he has accurate calibration 24 data and accurate decay data. 25 Now if there are 300 sources out there, I'm i ("'N ANN RILEY & ASSOCIATES, LTD.
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248 1 willing to bet that only half of them are in active use.
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2 And if one of the two national labs were given a contract to 3 calibrate these sources and they were competitively bidding 4 for the contract, I can't tell what the prices would be, but 5 if a lab was set up to do 150 sources, it could probably be 6 done for one- third of the. price, or half of the price, if 7 thereare sort of like an assembly line calibration 8 procedures to. calibrate, to have the contract to calibrate. 9 all these sources. 10 So if one lab calibrates all these sources, in a 11 sense it doesn't matter what they're measuring, if it's .99-12 rad or .98 rad, whatever they are measuring, they are l 13 measuring the same for everybody. And, therefore, everyone, 14 both new authorized users, who design prescriptions and () 15. 16 written directives and people who publish papers, are talking about the same unit of radiation measurement, 17 regardless of what it is, and then when an ophthalmologist 18 who takes over for a deceased ophthalmologist, like in 19 Puerto Rico, has a source, he knows that he's giving the 20 right doce rate because he has a calibrated source with 30 21 years of decay data supplied with that source. 22 And if this sounds like a radical recommendation, 23 I guess my question would be, are these sources required to 24 be calibrated? Now because the calibration is so 25 complicated,. extrapolation chamber, film measurements, and-l ANN RILEY & ASSOCIATES, LTD. s_/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
249 l t 1 it depends on who does the calibration, because it may be () 2~ 3 the calibration set- up. You could have three different ways of calibrating the source; all three ways could be 4 legitimate ways of doing it; all three ways could be without 5 error, but they all give slightly different answers, as 6 opposed to one lab with a contract to calibrate the sources. 7 The licensees, I think, would benefit because you could 8 negotiate, or the competitive reduced costs to calibrate the 9 sources. 10 Are the sources required to be calibrated 11 periodically? And I don't know the answer to.that. 12 CHAIRMAN STITT: Let me ask you a question. Of 13 the what, seven items that are up there, and there might be 14 more, which would you select or which combination - - () 15 DR. FLYNN: Number 6, except that I would require 16 that all sources be calibrated by a single national lab, , 17 either NIST or University of Wisconsin. They are very 18 light- weight sources, they could be shipped in DOT 19 transportation containers without any exposure to people in 20 transport. These sources are not used for emergency 21 treatment. I think if you asked everyone in the country, 22 all the authorized users, if you were without your source 23 for two weeks, would this impair your medical practice, I 24 think the answer would be no, because these patients are , 25 scheduled for treatment. It's not like - - you don't give i i O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
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'250 L 1 .a treatment at 2:00 o' clock at night. These are scheduled i
2 treatments, scheduled procedures. Any authorized user 3 probably goes weeks, many weeks or months, without using 4 that source. 5 So it wouldn't be a major problem. They weigh a 6 matter of ounces. They are easily shielded, they could be 7 easily shipped to a national lab, using Department of 8 Transportation shipping containers, which should be very 9 light- weight. containers. 10 CHAIRMAN STITT: Other comments? And other 11 comments on possible recommendations? 12 MR. SWANSON: Yes, I just heard Dr. Soarea say 13 that he would have confidence that certain manufacturing 14 sources and certain dates would be in calibration and have () 15 16 appropriate uniformity, therefore, is there a need to require all sources to come back?
- 17. DR. FLYNN: Well, I think what would happen - -
18 I'm not sure if he meant that if New England Nuclear, if he 19 saw nine sources and they all were good, or eight out of the 20 nine were good, if he had 30 sources from them, maybe three 21 were bad, we don't know, maybe the percentage of problem ! 1 22 sources is less for certain vendors, but I would say to l 23 solve the problem, to calibrate all sources on the same i 24 measuring stick, and solve the problem once and for all. 25 Many of these sources aren'te being used, they are i ANN RILEY & ASSOCIATES, LTD. (~} s,/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 ! (202) 842-0034 L
( 251 l 1 just being stored, and some aren't being very frequently, f 2 Would the licensees have'a problem with calibrating a source , 3 that should be calibrated, especially if they can get it 4 calibrated at a much reduced cost because they are all being 5 calibrated? 6 MR. SWANSON: Well, I'm not certain that we can 7 say it's going to be a much reduced cost, okay? I mean I'm 8 hearing $1600 per source, and I think that that's roughly 9 what we are going to have to expect the impact to be, okay? 10 DR. FLYNN: Well, I talked to the University of 11 Wisconsin, off the record, Chris Soares was on vacation and 12 I tried to call him, but - - or away, he wasn't in the 13 office, but I talked to the University of Wisconsin and they 14 said it would be calibrated at a much reduced cost if they () 15 16 had - - if you had a room set up and the calibration - - mean they don't calibrate these sources every day - - and I 17 if I'm wrong, you could speak up, but if you had a room set 18 up and a physicist or a junior - - whatever it would be, 19 set up and then it would be if you had all these sources in 20 a row, sort of like an assembly line, you can calibrate many 21 sources with the same geometric set- up much more 22 efficiently, rather than have to do the geometric set- up 23 every time. I mean you'd be all set up and ready to go and j 24 crank these out. 25 MR. SWANSON: I am not arguing that point, but who l 4 ANN RILEY & ASSOCIATES, LTD. O- Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
252
.1 is going to serve as the agent to submit a bid to get a l
l 2 contract to calibrate these sources? 3 DR. FLYNN: Well, I don't know if it becomes an 4 FDA problem, where we now'have a medical device which is 5 giving out an uncertain treatment that becomes a device 6 problem, and then - - or it becomes an NRC. problem, or 7 whether.neither agency wants to be involved. But - - 8 CHAIRMAN STITT: I don't think that ic'our 9 committee's issue, but it's certainly an issue to raise, and 10 then if that's a recommendation, then we'd have to look at ( 11 the pros and the cons, the expense. 12 DR. NELP: What does the T- 1 average? 13 DR. FLYNN: About 28- 1/2 years; something like 14 that. () 15 16 pencil up? CHAIRMAN STITT: Jeff? I think you had your-l- 17 DR. WILLIAMSON: Yes. I would certainly support 18 the recommendation that has been made regarding number three 19 and, you know, maybe number six. Number seven at most, I'd 20 question whether number seven is a useful way to address the 21 calibration issue, because the radiochromic films, at least 22 in my experience, seem to have a sensitivity that depends 23 significantly on their thermal history, and if you are 24 mailing these things around and the conditions under which I 25 .the users are exposing them and so on aren't controlled, I ANN RILEY & ASSOCIATES, LTD. O's Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l
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253 1 would be concerned about the accuracy of any absolute dose [ 2 rate derived from them. So I think that one would address 3 the issue of uniformity and whether these are good' sources 4 or not, or ought the users to be encouraged to withdraw 5 those particular ones. i 6 However, if number three were done, you know, that 7 would automatically include a uniformity profile, a dose map 8 of each source. 9 CHAIRMAN STITT: Number three is a recommendation; 10 six is a flat- out statement, at least the way I interpret 11 the way that's read. What's the price of a special 12 inspection to somebody that gets to have one conducted? 13 What is the answer on this, Cathy? Can you give us a 14 special deal since we're - - I presume that this is () 15 16 expensive and a number of places that use these probably don't have a lot of money. Let me get an answer to my 17 question. Any idea? Okay. Andrew has a question. 18 DR. KANG: I have one question for the gentleman 19 from NIST. I was wondering whether if we have any data 20 regarding the recalibration period - - in other words, 21 first purchased and the recalibration, whether it's five 22 years, ten years, twenty years, whether there is any 23' deviation from the accurate data, how much deviation is 24 different from five years versus ten years? 25 MR. SOARES: The only information I have is when I O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
254 1 get a source in, there's generally or often a calibration 2 information on the box itself which is generally performed 3 by the manufacturer, and that gives a date, and there's no 4 real strong correlation between quality of calibration and 5 date. There was some excellent calibrations done in the 6 1950s, at least excellent insofar as they agree with what I 7 measure now, and by the same token, there have been some 8 fairly recent ones which - - well, there's been no recent 9 ones as such, but some done maybe in the 1970s which were 10 not so good, including the ones done at NIST. So it's a 11 difficult thing to quantify. 12 DR. NELP: These weren't physicall deteriorating? l i 13 MR. SOARES: Generally not unless - - there were l 14 some that were encapsulated in silver and if they were () 15 16 cleaned in saline solution, that can cause some oxidation of the saline. I've seen one or two sources like that, and ; 17 gotten immediately worried about the condition of the 18 encapsulation and had them leak- checked extra special. But 19 I've never actually seen one of these things leak. 20 CHAIRMAN STITT: Dr. Wilson has a comment. ; 21 DR. WILSON: It's actually a point of information 22 responding to the question you asked of Madam Chairwoman, 23 because there has been concern in the practice community l 24 about the licensure costs associated with owning these 25 devices, and I am concerned about the added cost of O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
I l 255 1 calibration because these are seldom utilized devices in ("N - 2 many hands, as has been pointed out, and there has been
- 3. concern that increased costs associated with their use would 4 cause problems of patient access to the modality, looked at 5 as a cost center,-lead many hospitals who may be the actual 6 owners of these devices to relinquish them and the group 7 that is most at risk, in need of. treatment are migrant farm i
8 workers who work in dusty environments and are treated for 9 terregia cf the eye. So the reimbursement scheme for making 10 this medical treatment available is not generous. 11 CHAIRMAN STITT: Thank you very much. I wanted to 12 tell you where we are. 4:40, 4:20, the meeting closes at 13 5:30. 1 14 MS. HANEY: 5:00. i 15 CHAIRMAN STITT: Oh , oh, we're even shorter on 16 time. We need to finish our discussion to see if we are 17 going to be at a point of consensus, because it would be 18 nice to get - - well, Cathy and I will decide what it would 19 be nice to do, but with Dr. Paperiello here, it would be 20 nice to discuss the - - we'll figure it out. Go ahead with 21 your comment and then I want to see if we have - - 22 DR. FLYNN: My comment is actually I agree with 23 Dr. Wilson, and that being the case, given the medical 24 policy statement from the NRC, since NRC is concerned about 25 patient safety, I think that NRC could waive the license fee J ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
256 1 on the applicator for a year or two. I think NRC would be ("') (/ 2 very happy in the sense that, much more secure if all these 3 sources were calibrated, because you wouldn't have to pay 4 NRC consultants all these fees to investigate all these 5 misadministration, and the NRC would save money there. So 6 I think maybe if the fees were waived as part of a reduced 7 cost method of calibrating these sources, and so that it 8 doesn't infringe upon the licensee's ability to pay for 9 these calibrations, if they were all done, it would be in 10 everyone's interest. 11 MS. HANEY: There is not a fee for inspection. 1 12 The inspection fee is included in the annual fee that the l 13 licensees are assessed. There would be a burden on NRC 14 resources because the 300 inspections are not budgeted for () 15 16 and would ultimately end up getting included in an annual fee and getting spread out over - - 17 DR. FLYNN: Over many licensees? 18 MS. HANEY: Well, similar type of licensees, 19 because the annual fee for that type of user would go up 20 incrementally to cover the extra inspections, but if we 21 showed up on their doorstep, they're not going to get a 22 bill. 23 CHAIRMAN STITT: So obviously there is a lot ! 24 inherent and hidden in number six, and that would have to be 25 evaluated and worked out. O , ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters Washington, D.C. 20005 (202) 842-0034
257 1 Is there anybody who's in the mood for the motion
/~T 2 here?
tg l 3 CHAIRMAN STITT: Cathy? 4 MS. HANEY: I was going to say, let me add one 5 more thing here. There is nothing in the straw man rule for 6 this type of device, and at least maybe a long- term 7 . solution is should we put something into 35400 requiring a ! 8 calibration on whatever type of frequency for this type of 9 device? 10 CHAIRMAN STITT: Jeff? 11 DR. WILLIAMSON: Yes. Just a point of 12 information. Wouldn't this be considered a brachytherapy 13 source? I i 14 MS. HANEY: I would consider that, but I'm not 15 ( r)'
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sure whether - - l l 16 DR. WILLIAMSON: Because you'now have in the straw j 17 man rule a requirement for calibration of brachytherapy 18 sources. 19 MS. HANEY: And I don't know whether we would need 20 to actually'say specifically, you know, strontium 90 source, 21 but we did throw in the output calculation on the 22 brachytherapy. l 23 DR. WILLIAMSON: Well, I would be willing to make 24 a motion. I move that the ACMUI basically approve 25 particular' number three. I l s ANN RILEY & ASSOCIATES, LTD. t Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
258 1 CHAIRMAN.STITT: What kind of a motion was that?- [~h 2. Particularly number three? V 3 DR. WILLIAMSON: Yes. I move that we endorse 4 recommendation number three. 5 CHAIRMAN STITT: Anybody want to second it? 6 DR. FLYNN: I second it. 7 CHAIRMAN STITT: Okay. Discussion? l 8 DR. SWANSON: There are two problems here, or two 9 or more problems here. There is a calibration problem which 10 three would address. There's a problem that people aren't 11 correctly at their sites decay correcting the sources, and 12 if you look at the problems that were identified, some 13 people don't even know how to read a stopwatch apparently, 14 okay? () 15 Certainly. I think you have to do three and five. 16 At a minimum, I would send out another IN discussing the 17 importance of paying attention to some decay corrections on-
- 18 these sources. I agree that the calibration with the 19 30- day decay corrections is a good way, but, you know,
- 20 what's to say that they're going to pay any attention to
'21 that document, okay? So I think it's important to 22 re -emphasize the decay correction of - -
23 DR. FLYNN: Well, I think once - - it doesn't 24 cost'a single penny at the time of calibration to supply all 25 the decay data. So that'should be part of the calibration l'
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259 1 requirement, that whoever does the calibration supply a half
.( ) 2 life or 30 years almost worth of decay data as part of the 3 calibration, and then.we need - - they supply fou'r data 4 points per year so the radiation oncologist or the 5 ophthalmologist is using one surface dose rate in centigrade 6 per second from January to March, then the second one, which 7 was slightly less, from April to June.
8 All that is is two pieces of paper, and it's 9 supplied with the calibration, and it's done at absolutely 10 no cost. 11 DR. SWANSON: I agree, but in the interim, I think 12 it would be appropriate to reemphasize decay corrections. 13 I'm also concerned about the training and experience of 14 these people, but according to what we just voted on, () 15 they're going to have'to have three years of training in the 16 use of this device anyway, so I think that will probably 17 cover it. 18 CHAIRMAN STITT: Three and five hit a lot of it. 19 When you read through the misadministration and their 20 summaries, it covers a lot of them. So those link together 21 quite nicely. ! 22 Are there other comment about the motion? l 23 MS. WALKUP: In other words, is this a 24- recommendation, not a requirement that they be recalibrates? 25 Number three, it says - - I ANN RILEY & ASSOCIATES, LTD. O. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
260 l l 1 CHAIRMAN STITT: Right. 2 MS. WALKUP: So there's no enforcement? 3 CHAIRMAN STITT: That's right. It's not as strong 4 if we go with that. 5.. DR. PAPERIELLO: Can I just make a point? We can 6- never issue an IN which has a requirement. Just as a legal !. 7 matter, information notices can never establish a legally 8 binding requirement. l 9 DR. FLYNN: Information bulletin? 10 DR. PAPERIELLO: I'm sorry? 11 DR. FLYNN: How about an information bulletin? 12 There's another term they use - - is it bulletin? - - that 13 has a requirement. 14 DR. PAPERIELLO: Yes. Even in bulletins, although 15 they can request a response, but they can't establish a 16 requirement beyond a response. 17 DR. FLYNN: When you had the - - with'the HGR 18 accident in Indian Head, Pennsylvania, wasn't there a 19 .certain response required by the Omnitron users? 20 DR. PAPERIELLO: Yes, there was, but it was a 21 voluntary response for information. Obviously the agency. 22 would have to make the decision in the case of a bulletin. 23 If there was not a response for information, then we could 24 turn around and issue an order, and that would then 25 establish a legal binding requirement. But particularly in fh l 'd ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
i 261 l l 1 this case, information notices are extremely sensitive when 1 ('T 2 an information notice is establishing a requirement. It j
\s,) ;
3 just conveys information. ' 4 CHAIRMAN STITT: Dennis? ; 5 DR. SWANSON: Could you remove these devices from 6 your approved list of devices and then come back and say, in 7 so doing, that they would have to be evaluated on an 8 individual basis? 9 MS. HANEY: What you're saying is take it out of 10 the sealed source device registry? 11 DR. SWANSON: Yes. 12 MS. HANEY: I guess if we had good cause to, we ! 1 13 could, but if the question is whether they need to be I 14 calibrated or not, it's not really a result - - don't take (9) 15 the source out of the sealed source device registry; require 16 them to be calibrated; and if ;here are enough cases, then, 17 as Carl said, we can issue orders that said "shall." I mean, 18 it's a heck of a lot more administrative loops we have to 19 jump through in justification, and they really start looking i 20 at health and safety. It's almost justifying it as if -- 21 well, it is justifying it as if it's a rule. But that's the 22 problem, not that the SS&D sheet is wrong. 23 CHAIRMAN STITT: Other commentary? 24 The motion currently is that we adopt or that we 25 support number three. We also have been discussing, but we
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262 1 haven't done anything parliamentary about three and five. /~T 2 MS. HANEY: If we do three, it's very easy to \v) 3 throw five. So you might want to amend an amendment -- 4 CHAIRMAN STITT: Can you amend your own motion, 5 Jeffrey? 6 DR. WILLIAMSON: Yes. I would be happy to amend 7 my motion as follows. The ACMUI recommends the adoption of 8 recommendations three and five. 9 CHAIRMAN STITT: Is there a second? 10 Will, thank you. 11 Other discussion? 12 [No response.] 13 CHAIRMAN STITT: Ready to vote? 14 DR. FLYNN: Will it say to be recalibrates by who /m't 15 or by how? In other words, if people out in - - NJ 16 MS. HANEY: In the information notice, we can put, 17 you know, suggestions, but we can't say that it must be 18 calibrated by NIST or by a university. 19 DR. FLYNN: So in mentioning it, can you say a 20 standard lab using current standardized techniques? 21 DR. PAPERIELLO: I would like to respond to that. 22 I can certainly put in an information notice that when it's 23 recalibrates, it has to be by somebody who has, you know, 24 the physical ability to do it, and obviously somebody who 25 would turn around and do this - - you know, a device which l (~'N ANN RILEY & ASSOCIATES, LTD. ! ( ,) Court Reporters l 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l (202) 842-0034 i l
263 l 1 is normally used to calibrate a photon beam is certainly 2 inappropriate. So you would tell people, if you're going to 3 put out an information notice, that the number of 4 laboratories that are capable of doing this is limited, and 5 the ones we are aware of is this, and caution them about 6 having just somebody who comes along and says, "Oh, I can 7 calibrate it" do it. 8 I mean, that is what has happened in these cases. 9 You know, people have offered their services to the 10 physician who are basically unable to do the job. I mean, 11 we have warned people of this, because obviously if people 12 go out and recalibrates and get an individual to do it who 13 did what has happened in the past, we could have a worse 14 problem than we have now. () 15 CHAIRMAN STITT: Ready to vote? Those in favor of 16 the amended motion, which is ACMUI accepts number three and 17 number five, raise their hands aye. 18 MS. HANEY: Nine in favor. 19 CHAIRMAN STITT: Those opposed? 20 MS. HANEY: None. 21 CHAIRMAN STITT: Good. 22 Cathy would like to move on to - - I think we 23 have two final issues we're going to address today. That's 24 4:00 and the 4:30. Hey, we're going to finish right on 25 time. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
264 ! 1 Our old friend, Torre Taylor. l 1 2 MS. TAYLOR: Hi. I'm Torre Taylor. [ 3 Okay. I'm going to do the probably more mundane ) 4 issues, but we have to address the Commission's SRMs, so we 5 need some input from you all. 6 The ACMUI had a Commission briefing May 8th, 1997, 7 as you all remember, and the Commission forward its staff 8 requirements memorandum to the ACMUI, directed it to Dr. 9 Stitt as the chairperson. It requested the ACMUI to take a 10 focused look at the provisions of Part 35, include test 11 cases, and look at the revisions as we move toward a more 12 risk- informed performance- based regulatory program. I 13 They requested you to address specific questions, 14 and the new due date to respond to this SRM is May of '98, l () 15
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so time is short. We will prepare a formal response 16 incorporating the discussion from this meeting and then we 17 will send it out to you all for your review, and it will go 18 out under Dr. Stitt's signature to the Commission. 19 I understand that it was discussed at the last 20 meeting. You all asked us to provide some thoughts on the 21- questions to discuss at this meeting, and those thoughts are 22 in your briefing book and was a brainstorming session by 23 other staff. I wasn't involved in that, so if we run into 24 any glitches, I'll have to pass that on to Cathy. 25 MS. HANEY: Torre, they're not in there. They're ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l L _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ ___ _ ________ ____ __. _______
265 1 not in the briefing books.
/ ~^- 2 MS. TAYLOR: The SMR with these questions are and 3 the - -
4 MS. HANEY: The SRM is - - 5 MS. TAYLOR: And I understocd that the information 6 from the brainstorming was in there. 7 MS. HANEY: Is it? Okay. Then you guys got a 8 special version that I didn't get. 4 9 MS. TAYLOR: Oh, actually, it is out of place. It 10 was in the previous or subsequent tab. 11 The first question was, how should NRC determine 12 which industry standards are adequate, how much flexibility 13 should licensees have, and how should, quote, quality 14 improvement be incorporated into a reliance on industry O V 15 standards? 16 MS. HANEY: Torre, hold on a second. What Torre 17 is referencing is an SRM dated June 5th, 1997. That's where 18 you'll find the actual SRM. But if you page forward, go 19 into the next tab and go up four or five pages, then you 20 will get the results of just a brainstorming session that 21 were answers to these questions just to step through to give 22 you something to look at. The top of the page will say 23 SRM- M 0508. 24 MS. DURHAM: Where? 1 25 MS. HANEY: Just go - - find the SRM dated June i l t l r~% ANN RILEY & ASSOCIATES, LTD.
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t 266 1 5th, 1997, and then go forward. 2 MR. GRAHAM: It's toward the front. Okay. 3 MS. HANEY: Toward the front of the book. Sorry. 4 MR. GRAHAM: It's in the tab. 5 DR. WILLIAMSON: It's the last item in there. l 6 MS. TAYLOR: It's June 5th, '97, '96 tab, and if l l 7 you go just in front of that, the last pages there actually 8 belong there. 9 MS. HANEY: I think we're with you. Go ahead, 10 Torre. 11 MS. TAYLOR: Okay. You all can read the question 12 there. I 13 In essence, the summary was that NRC should 14 definitely review the industry standards that are developed [d \ 15 by professional organizations such as AAPM, S&M, ACR, and 16 that licensees should definitely have maximum flexibility in 17 utilizing these standards. 18 What we would also need from you all is exactly 19 what organization should we look at or should we tie it to 20' anything. They're pretty standard out there now, but make 21 sure that we know which ones we definitely should look at. 22 We do need ideas on how quality improvement should 23 be incorporated into reliance on the industry standards and 24 how we should determine that these standards are adequate. 25 I didn't really put much in my notes on the second f-(" ANN RILEY & ASSOCIATES, LTD. ( k Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 L-___._-_-______...-___-_-__-
i j 267 , j 1 two issues about quality improvement and how we should (~' 2 determine that they're adequate. I didn't really get into l
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l 3 all the details of that brainstorming session, so I thought , I l 4 I would let you all give me ideas. If you want to go I t 5 through all the questions and then go back through or 6 address each one - - 7 CHAIRMAN STITT: Why don't you, yes, because we're 8 short on time and everybody is tired, and we've been through j 9 this a lot. 10 MS. TAYLOR: Yes. 11 The second question you can read in essence boils i 12 down to how we can develop a more positive enforcement ' 13 program as we make this transition to the new regulations, 14 but we still need to address the outliers and what criteria () 15 16 should we use to decide if this approach is even working. In reading the suggestions that's in the book, it 17 appeared to address more events, but the actual issue j 18 applies to all enforcement cases, which won't always be on 19 just events. 20 The enforcement program has to be reviewed against 21 the revision to part 35, obviously, and we have to develop a 22 transition plan. We do plan to hold meetings with the 23 Office of Enforcement, the Office of General Counsel and the 24 regions, and the rulemaking staff also to discuss the 25 provisions within the revision to part 35. I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
268 1 Some suggestions that have been thrown out is that 2 good performance gets a decrease of frequency of inspection, 3 which is already in place to a degree. My thoughts is there 4 should also be a decrease in the depth of the inspection, 5 including minimizing reactive inspections to those 6 facilities that run really good programs. 7 We can have voluntary reporting for events. 8 Precursor events should not be used-as a mechanism for 9 enforcement. Such precursor events would be j i 10 hardware / software failure of dosimetry systems. These l 11 aren't required to be reported in any form. 12 NRC has to train their staff, including inspectors ; 13 and management, on the revisions to part 35 which discusses j 14 the intended rule and the philosophy behind the revisions. () 15 16 Written guidance has to be provided to the regions and to headquarters staff, and the reason we put this in there is 17 that we do, on the philosophy issues, we do have statements 18 of considerations behind all of the rules, and unless you 19 have those loose- leaf binders of the regulations, not all 20 licensees actually have the philosophy. So it's important l 21 that the staff understand all the philosophy so they can get 22 that information out to their licensees also. 23- Communication has to be emphasized during the 24 transition. Headquarters currently conducts routine monthly l 25 conference calls with the regions, and these will continue. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
269 1 These calls involve general issues that are going on with l [J] 2 3 different regulatory issues ~ IMAB, which is now the materials safety branch, 4 and regional coordinators at headquarters are also involved 5 in enforcement issues with the regions, so there will be 6' extensive communication going on as we go through this, as 7 questions come up and as enforcement cases come up to make 8 sure that there is a consistency and that they are actually 9 enforcing against the new revision. 10 Timely self- identification with good licensee 11 response and corrective actions to address the root cause of 12 an incident or a problem with the program will carry the 13 least amount of enforcement. Another question is, should it 14- carry any enforcement? () 15 Events identified after repeated occurrences 16 and/or significant period of time would get more 17 enforcement. This can be an indication of poor program 18 oversight or communication within the program. 19 Inspection responses to events can be reviewed to 20 determine if there is a negative impact to licensees. NRC 21 could also limit the number of event inspections. A 22 question that needs to be addressed is, are there any cases 23 where events should not trigger an inspection? An example I l 24- came up with was therapy treatments gone awry because of 25 patient intervention if it's clear patient intervention. i ANN RILEY & ASSOCIATES, LTD. [s_)) . Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
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270 1 Another option is to increase the depth and detail 2 of an inspection based upon the higher severity and (J^} 3 increased risk of the event. 4 NRC could develop a process for licensee feedback 5 on the inspection and enforcement process which would be 6 voluntary. Staff could compile this data and review it 7 periodically. We could also establish a website or request 8 comments and guidance documents on the enforcement process. 9 Regarding methods to determine if our approach is 10 working, we could survey licensees through a formal survey 11 process. We could track voluntary reporting against 12 , inspection findings for individual facilities and/or by 13 license type. I didn't know if there are any ideas on that. 14 We need some work on that. I guess the main question is, do rx I (d' 15 you think there would be any voluntary reporting? I 16 MS. HANEY: Torre, let me just say something. 17 Torre had mentioned that this was a result of the 18 brainstorming session. We really did this because at the 19 last meeting, we had all said that it would be better if we 20 brought something to you and let you mark it up as compared 21 to just starting from scratch. So realize that these are l 22 not things that we want you to come back and tell us, nor 23 are they things that we don't want you to come back and tell l 24 us. It was just, you know, sitting there saying, you know, l l 25 how could you possibly answer these questions and what are (N ANN RILEY & ASSOCIATES, LTD. (,) Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
271
-1 all the different alternatives out there?
2 You know, some of them are doable in NRC space, 3 some are not doable in NRC space, but it's really '- - it 4 was just something to give you a starting point. So if this 5 whole document got trashed and was not used, that's fine 6 too. 7 MS. TAYLOR: NRC's philosophy, right? 8 The third question is, in considering events, what 9 criteria should NRC use to determine that event is isolated 10 versus having implications for that licensee versus having 11 generic implications across all licensees in that type of 12 category, and what is the best process for reporting events 13 to ensure NRC is aware of generic issues.
-14 We do review reportable events.. We should also )i
/s I
( ) 15 review data in INMED, which is a database where events are
%J 16 reported. We need to look for trends and we need to look at i 1
17 root causes. 18 We should also look at the compliance and 19 performance history of licensees - - there can be some 20 variances in that - - to determine if it's with the 21 licensee or a generic issue. 22 To ensure NRC is aware of generic issues, we could
.23 establish voluntary reporting with no enforcement or 24 reactive inspection. We could develop an easy electronic or j 25 mail in a form for this process. ;
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272 1 The question again is do you think people will 2 report voluntarily or should this be delayed until licensees 3 have gained trust that there will not be any punitive 4 enforcement if they do notify us. We could establish a website that identifies our 5 6 reports, which allows easy searches by licensees, encourages 7 licensees to identify any additional events which can 8 provide valuable information related to possible generic 9 implications. There was discussion that we could extend 10 this internationally as well. 11 Question four. In evaluating errors, should a 12 threshold be established beneath which correction action is 13 not required, and how would this threshold be set, and how 14 would it be implemented? Thresholds should be based on () 15 risk, with higher threshold for lower risk activities. 16 Reports for errors below this threshold would be voluntary. 17 How should we establish this threshold and at what 18 levels and for what types of errors? And these are some of l 19 the things that we need your input on. 20 Now, we are due to get this back to the Commission 21 in May, so we will have to take anything that comes out of 22 this meeting and put it together. l 23 MS. HANEY: And what we're looking for is a report i 24 that comes from the ACMUI to Don Cool, because this is a 25 division - - a committee that reports to Don Cool as l 1 1 ANN RILEY & ASSOCIATES, LTD.
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273 1 compared directly to the Commission, and then all we'll do 2' is we'll put a cover letter on it and say this is in 3 response to staff requirements memorandum whatever, this is 4 ACMUI's response, because they are looking for your response 5 on this, not staff's response. 6 CHAIRMAN STITT: Okay, Committee, how do you want 7 to start handling this? Obviously we're not going to 8 ' complete this in 15 minutes. 9- DR. NELP: I think, if I understand this, the 1 10 Commission has asked the staff to respond to these 11 questions? 12 MS. HANEY: No. The Commission has asked the 13 ACMUI to respond to this question. All we did was come up 14 with just a list of like a starting point or some things for
- ( ) 15 the ACMUI to consider so you weren't starting with nothing.
16' CHAIRMAN STITT: And many of the things that are. 17 in here, I recall specific people making specific comments 18 at different points in our many meetings.
.19 DR. NELP: And these people are staffers or rather 20 --
21 MS. HANEY: No. Really what this came from is 22 things that we have heard you give to us over the years, i 23 DR. FLYNN: On an informal basis. 24 MS. HANEY: Well, -- l 25 DR. FLYNN: Well, I mean periodically. ANN RILEY & ASSOCIATES, LTD.
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274 L 1 MS. HANEY: Yes, on that basis, and kind of i l () 2 saying, if I were still writing this document and I was a 3 member of ACMUI, what would I put down? 4 DR. NELP: It's a rather impossible task for us to 5 accomplish in a 15- minute period. I'm wondering if the 6 staffers in behalf of the committee couldn't prepare what 7 they think would be most -- the questions aren't very good 8 questions, to begin with, and, you know, if somebody asks 9 you a question, I'm not sure you're obligated to answer it. 10 MS. HANEY: If the Commission asks us a question, 11 we're obligated. 12 DR. NELP: Well, and as the committee, I don't 13 think we're obligated to answer this question beyond in 14 general approval of what staffers might wish to do. () 15 MS. TAYLOR: Let me interject here. You can go 16 back as a committee and explain why you don't think a 17 question is valid and why - - 18 DR. NELP: Well, I don't think we - - this could 19 take us a week to.run through this ramification. I'm 20 suggesting that maybe you could send us a synopsis of what 21 you think you really want us to talk about, and then let us 22 communicate with you at a separate time. 23 CHAIRMAN STITT: This is the synopsis. This is as 24 far as the staff can take it.
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25 DR. NELP: Well, I would suggest you re- synop. ! f [ ANN RILEY & ASSOCIATES, LTD. Court Reporters , 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034
275 1 [ Laughter. ]
~S 2 CHAIRMAN STITT: Well, it has to be based on our (s 3 opinions.
4 I would have to say I don't know why the 5 Commissioners came up with this. It was something that 6 supposedly was written in June of a year ago. I had never-l 7 received the thing despite the fact it was written to me, l 8 and it kind of surfaced through a series of phone l 9 conversations. I don't know what they want from us. They 10 l certainly know our feelings because we send them to - - 11 send our feelings to them regularly. Nor do I know what 12 they want to do with this. 13 DR. NELP: You could say that the staff has 14 genuinely reflected our feelings, give this response back to () 15 16 them. l CHAIRMAN STITT: Jeff, you have something to say? 17 DR. WILLIAMSON: Well, it looks like, from the 18 language here, this was drawn out of our briefing from May 19 8th of that year, and they were, I would hypothesize, l 20 somewhat stung by our various criticisms and are asking us 21 to give more details. 22 CHAIRMAN STITT: That's my guess as to the - - t 23 DR. WILLIAMSON: I mean, that's what this is all g 24 about, and - - 25 CHAIRMAN STITT: -- ideology and the origin of I l ANN RILEY & ASSOCIATES, LTD. g]) s, Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l E___--------------------------------------.---------- - - - - - - - - - - - - - - - - - - - - --------J
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276 1 this. 2 Cathy? 3 MS. HANEY: Well, could I propose that maybe a way 4 of handling this is that rather than discuss it in this 5 forum, which it will take a lot of' time, is that now each of 6 you'have this, if you could, on your flights back, just go' 7 down this list and either X out.what you like.or X out - - 8 or add in what you do like and then send it back in to Dr. 9 Stitt, I think, and - - 10 DR. NELP: Excellent. 11 MS. HANEY: And then we can just make the changes l 12 to the form, assuming that you're just Xing and adding. I 13 mean, it's a matter at that point we can act as secretary. 14 But basically, it's the input from each one of you ) () 15 16. _ individuals to Dr. Stitt, and then we would turn around a cleaned- up document, give it back to Dr. Stitt, and it was 17 up to her if she wants to sign it or not as chair. 18 CHAIRMAN STITT: Okay. Let's go down the 19 left- hand side here. 20 Ruth? 21 DR. McBURNEY: Would that include the non- voting l 22 members? Do you want - - 23 MS. HANEY: No. i
'24 DR. McBURNEY: --
their input as well? 25 MS. HANEY: It would not. j I l l O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 i a- _ -_- _ - _ _ _ _ - _ _ _ _ _ _ - _ _ _ - _ _ _ _ - - _ _ _ -_ . _ _ _ _ _ _ _ _ _ _ _ _
277 1 DR. NELP: I think that is an excellent 2 suggestion. []
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q 3 CHAIRMAN STITT: Good. 4 Next? Go ahead, Theresa. 5 MS. WALKUP: On number two, maybe this is out of I 6 line, but I think during the beginning of this, it would be 7 nice if when the inspectors do come to your institution, if 8 you were able to evaluate their performance as a feedback to 9 the NRC. I mean, were they helpful, did they - - you know, l 10 some sort of evaluation on their part and how they could 11 better do it. l l 12 CHAIRMAN STITT: That's an excellent idea. How 13 long is your flight? You can get that written down your 14 flight back, right? A 15 ( ) MS. WALKUP: Yes. 16 CHAIRMAN STITT: Good. 17 Jeffrey? Jeffrey, when are you leaving the world 18 - - when are you leaving us for the rest of the world? 19 DR. WILLIAMSON: Soon. March 15th. 20 CHAIRMAN STITT: Okay. 21- DR. WILLIAMSON: Any pearls of wisdom you're going 22 to extract from me will have to be done very rapidly. 23 CHAIRMAN STITT: Okay. 24 DR. WILLIAMSON: Well, I don't know how seriously 25 or how much effort we should put in this. If we wanted to r ANN RILEY & ASSOCIATES, LTD. {s)T Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 L
278 1 really make a good statement, you would have to kind of 2 assign us various bits and pieces of this to write and then 3 circulate them to all of us and kind of come up with some 4 sort of a structure where the e- mail - - we could put 5 something together which would be similar to the preparation 6 we went through for our briefing. So if we want to do a 7 -- CHAIRMAN STITT: That got us in a lot of trouble, 8 so I think we're all reluctant to say too much. 9 Comments down the right side of the table. 10 Nothing? 11 DR. CERQUEIRA: I look forward to my plane ride. 12 CHAIRMAN STITT: Dan? 13 DR. FLYNN: Well, I mean - - 14 CHAIRMAN STITT: John? () 15 16 DR. FLYNN: I'm not sure that when I looked at question 1, for example, that I don't remember in our 17' -minutes - - in terms of professional societies, I think ' 18 it's reasonable to look at professional societies and to 19 limit the number but not be restrictive. 20 For example, AAPM, ACR, ABS perhaps or American 21 College of Radiation Oncology, but let's say societies which 22 have - - where at least 50 percent of the affected 23 individuals - - where the membership involves 50 percent or 24 more of the regulated community, therefore, you're not -- 25 you're restricting but not inflexibly to major societies ANN RILEY & ASSOCIATES, LTD. s ,/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l l l
h l-279 1 rather than a list of 30 different regional organizations. () 2 3 I mean, it should be national societies where most of the affected community is a member. 4 When you look at accreditation approaches down at l ! 5 the end of question 1.C.3, about two- thirds of the way down 1 6 the page, accreditation approaches used by JCHO, JCHO does 7 not do technical accreditation when they review uites. 8 There was a site in Texas which passed JCHO with highest 9 marks and then a month or two later, it failed ACR 10 accreditation because the technical accreditation went bad 11 but the policies and procedures were fine. 12 So I think you would not want to use the type of 13 accreditation that does not focus on the technical 14 accreditation process. 15 CHAIRMAN STITT: Other comments people want to 16 make? Go ahead. 17 DR. CERQUEIRA: Just sort of a question because I l 18 wasn't around May 8th of '87 when this meeting was held. 19 How much of these questions are going to be outdated on the 20 basis of all the revisions to straw man and everything that 21 has been done, and how well can you answer these questions 22 until we know - - at least have some idea what the 23 Commissioners are going to do relative to our 24 recommendation? 25 CHAIRMAN STITT: I think this was their response, l CS ANN RILEY & ASSOCIATES, LTD. lkl 1
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l 280 i I which now seems like it was decades ago, to our 2 presentation. We spent time talking about quality assurance 3 and quality improvement, we made recommendations about JCHO ! 4 type of thing. That's what that comes from. So I think l 5 this is already outdated. Much of what we have been saying 6 is important to us, we've been saying all along as we've 1 7 been trying to give our input to NRC staff through this 8 rulemaking provision process. So I feel that we shouldn't 9 be spending a lot of time on it, quite frankly. 10 Cathy, you had something to say? i 11 MS. HANEY: Well, I was just going to say i 12 originally, this was due to the Commission, I believe it was 13 January or February, whatever, and we extended the date, 14 which is not the easiest thing to do when you have a task l () i 15 that's due from the Commission, but we extended it to match 16 the straw man rule such that, in answering these questions, , 17 it would be input that you would be giving us along the 18 process, and again, what happens after the straw man, who 19 knows, but at least it was things that should be considered j 20 in going into the straw man. l 21 CHAIRMAN STITT: And it should reflect our 22 thoughts as we've been going through this process. That's 23 why I think we can respond back. We'll let everybody l 24 comment, but what I would like to do is have people make 25 comments in the margins, cross things out, put exclamation
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i 1 281 1 1 points, things you can't stand, let me know, write in things
<% 2 that you want, send them back to me personally, and then
- b. 3 I'll collate something.
4 Jeff. 5 DR. WILLIAMSON: Well, I think maybe to sort of 6 help focus this and make it most relevant, I think we should 7 make it clear, you know, when we think that a question is 8 now irrelevant given the subsequent events that have 9 happened, and I think we should really temper what we're 10 saying by what has happened so far in the revision process, 11 because a lot has happened since May 8th of '97 and now and 12 many of these sort of issues were preliminary discussions of 13 philosophy which simply are - - there's no point in 14 reviving them.
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[\ 15 I think an area that really could be emphasized a d 16 lot, where it's still valuable to emphasize, would be the 17 many complaints we had about the enforcement process a.nd its 18 rigidity and its unwillingness to include clinical judgment. 19 That's one of the arguments we made before the Commission, 20 how that seemed to us to distinguish quality assurance from 21 quality improvement, so forth. So I think maybe issues like 22 that are still relevant. 23 CHAIRMAN STITT: Other comments? 24 Thank you, Jeff. 25 Dan and then Naomi. l ANN RILEY & ASSOCIATES, LTD. O Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034 l I
282 1 DR. FLYNN: Also, that we focus - - recommend 2 that the NRC would focus the enforcement and inspection (')T 3 frequency based on licensees who have high- risk procedures, 4 and perhaps - - and you can work in the accreditation 5 process by professional societies in a way that your 6 inspection frequency is modified if you have accreditation 7 by a certain professional society which has sufficient 8 membership, that maybe with this accreditation process, 9 perhaps, for example, the inspection frequency is less than 10 it would be if you don't have some type of national 11 accreditation behind your - - you know, under your belt. 12 So high- risk procedures should be the focus, I think. 13 CHAIRMAN STITT: Naomi? 14 DR. ALAZRAKI: Well, I guess this is an () 15 opportunity to tie into the medical policy statement where i 16 we said that the assessment of risks justifying such 17 regulations will reference comparable risks and comparable . l 18 voluntary standards and modes of regulation, referring again 19 back to the professional societies, and if we could put 20 together some of the voluntary standards which would come 21 out of those groups, that would be something perhaps l 22 substantive. 23 CRAIRMAN STITT: Okay. Good. 24 DR. ALAZRAKI: But that will take a little bit of 25 -- r ANN RILEY & ASSOCIATES, LTD. ! f'T - Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
283 1 CHAIRMAN STITT: Well, I think what we're going to l. () 2 3 end up with is bullet points. large tome here, but bullet points in an outline form. I don't personally see a j 4 Lou. 5 DR. WAGNER: I personally believe that, number 6 one, I couldn't do a good job on this until we have some i 7 idea what the final regulations are going to look like, and i 8 number two, to do something under too short a notice with 9 too little information is, to me, foolhardy. I'm not sure 10 that it's really worthwhile. Maybe a recommendation - - l 1 11 advise the Commission that we think this short order in 12 addressing these issues at this time simply - - it's simply 13 too short, it's simply too constraining given the limited 14 situation where we sit, and maybe we could recommend that I ( ,) 15 they look at an extension of the completion of this until 16 sometime after which we know what the rules are really going 17 to look like. 18 CHAIRMAN STITT: Well, they sent it out in June of 19 last year. 20 DR. WILLIAMSON: But we didn't get it. I mean, I 21 think - - 22 CHAIRMAN STITT: I mean, I^ agree with you 23 completely. , i 24 DR. WILLIAMSON: This deserves a complaint, I 25 think, that we're put in an impossible position. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
284 1 CHAIRMAN STITT: I think we're being punished. We { 2 went and gave our opinion and we're being punished by 3 additional homework. 4 MS. HANEY: Well, also, Jeff, this was discussed 5 at the meeting six months ago, so this is not the first time 6 that it has been brought to the ACMUI. 7 DR. WAGNER: Yes, but its volume is just 8 overwhelming in terms of what to do, to look at it and not 9 even know what the regulation is. 10 CHAIRMAN STITT: Well, if you'll send me stuff, I
- 11 will find some bullet points to send back to them, and I 12 think - - I mean, I could write a paragraph that says this 13 reflects some of our thoughts on how we were making 14 decisions, some of the parameters we were looking at as we 1% }} 15 were working on the revision to part 35 to illustrate that 16 this is our discussion of how we view this work in progress, 17 try to put it into context.
18 DR. NELP: I would like to make that as a motion, 19 that we respond to you in an informal fashion as you have 20 indicated, and that you can give them a preliminary note of 21 our feeling. 22 CHAIRMAN STITT: Second by? 23 DR. FLYNN: I'll second it. 24 DR. NELP: Thank you. 25 CHAIRMAN STITT: All right. Those in favor? l
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l 285 1 MR. GRAHAM: Hold it. i 2 CHAIRMAN STITT: We've had discussion. 3- MR. GRAHAM: We have to have discussion. 4 CHAIRMAN STITT: All right. Go ahead, John. 5 MR. GRAHAM: Are we going to have discussion after 6 the motion? Thank you. 7 CHAIRMAN STITT: Go ahead. 8 MR. GRAHAM: My only concern echoes Lou's 9 comments. Yes, we discussed this in an earlier ACMUI 10 meeting; yes, those of us that were here when we gave the 11 briefing to the Commissioners have some understanding of why 12 these questions may have been generated, i ! l 13 At the last meeting, it was my understanding that ] 14 we agreed as a group that we were going to focus l () 15 constructively, proactively on how to rewrite section 35 as 1 16 opposed to continuing to dive into the depths of our ; 17 complaints about the way the regulations had been I 18 administered in the past. 19 So I guess my only concern and caution with ! 20 respect to Will's motion is that I would - - I'm leaning 21 towards a paragraph from the chairman to them simply stating 22 that we have been focusing our entire effort on working with 23 the staff to develop the best language possible for the 24 revision of part 35, and that in our opinion, these 25 questions have become irrelevant and/or will be incorporated
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l 286 l' into those recommendations.
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G 2 DR. NELP: I will withdraw my motion if you have 3 an alternate. 4 MR. GRAHAM: It would be that latter. So moved. ) l 5 DR. NELP: I will withdraw. 6 CHAIRMAN STITT: Dennis? 7 DR. SWANSON: Further discussion. If you go back 8 and read the - - what is it? - - the SRM? Whatever we 9 call it. It says the Commission requests the ACMUI to take 10 a focused look at the revisions to part 35, which I'believe 11 we're doing, including test cases, as the Commission moves 12 towards a more risk- informed performance- based regulatory ) i 13 program. 14 In providing recommendations - - I'm assuming 15 that means providing recommendations on part 35 - - the 16 committee should address the questions posed by the 17 Commissioners during the meeting which include the 18' following. 19 Now, let me state, I think that as we are 20 providing our recommendations to part 35, we are, in fact, 21 taking into account these questions. I don't think that , 22 this SRM itself says that we have to answer each of these 23 questions independent of our recommendations on the proposed 24 part 35, and I think that is, in fact, a misinterpretation 25 of this SRM itself. l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 l (202) 842-0034 l'
287 1 CHAIRMAN STITT: So are you suggesting that I 2 should send a response to the NRC with some phraseology - - (')T u. 3 DR. SWANSON: The response could be very simple. 4 We are taking into account each one of these questions as we 5 are providing our recommendations to the revisions of part 6 35. 7 CHAIRMAN STITT: Now, there's not a soul who's 8 going to argue with that because that means you guys don't 9 have to do any extra work. 10 MR. GRAHAM: Well, this should be a very brief 11 statement and I don't think it's rhetoric. We spent hours 12 today talking about standards for training, spoke 13 specifically about external guidelines could be used for 14 certain parts of that training, and made very concrete 15 recommendations. 16 DR. SWANSON: I think we're answering their 17 questions. 18 MR. GRAHAM: I think we're answering their 19 questions through the part 35 review. 20 CHAIRMAN STITT: Or our participation. 21 DR. SWANSON: If you'll recall, we spent a fair 22 amount of time this morning discussing the role of the 23 guidance document vis- a- vis the regulations, which clearly 24 comes under the second part of question number one: To what 25 extent should NRC allow the licensee flexibility in l ANN RILEY & ASSOCIATES, LTD. O-Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
F \ 288 l' interpreting and selecting an industry standard? I mean, l () 2 3 we're doing this, okay? I don't think that - - I don't interpret this as meaning that we have to address these 4 questions independent of providing our recommendations on L 5 part 35. That's not what this says. I 1 6 MR. GRAHAM: That's what I'm recommending as a 7 motion. 8 DR. SWANSON: I'll second that motion. 9 CHAIRMAN STITT: Is there a vote? 10 DR. NELP: Call for the question. 11 CHAIRMAN STITT: Is that part of the motion? 12 Those in favor? 13 Those opposed? 14 I'll abstain. No , I'm in favor. f~ 15 Nine in favor, zero opposed, and we'll see what we 16 get back. I i 17 MS. HANEY: There's another SRM. ! i 18 CHAIRMAN STITT: Go ahead, Torre. 19 MS. TAYLOR: Okay. This SRM is dated August 21st 20 of '96, and it didn't come to you all directly, it came to 21 the different program offices. This was done as part of a 22 strategic assessment effort. The Commission evaluated the 23 agency's independent -- 24 DR. NELP: Where is it? 25 MR. GRAHAM: Clarification, it's under tab COMSEC l ANN RILEY & ASSOCIATES, LTD. , \m Court Reporters I 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
289 ' 1 96- 028. () 2 3 MS. TAYLOR: The Commission evaluated the agency's independent Thank you.
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4 technical oversight committees as part of its overall 5 strategic assessment efforts. This includes committees such 6 as ACMUI, the Advisory Committee on Nuclear Waste, and the 7 Advisory Committ ee on Reactor Safety. There's a couple of 8 other smaller, low- key advisory committees also in the 9 agency. 10 The staff was informed of its decision in this SRM I 11 dated August 21st of '96. The Commission stated that each 12 committee should be evaluated to determine what value it is 1 13 contributing to achieving the agency's mission. The j 14 committee should also be directly involved in this () 15 evaluation. 16 They also asked each committee to develop a set of 17 criteria for Commission consideration, which means we do 18 have to go back to them with the criteria und.er which the 19 performance of the committee would be evaluated in the 20 future. 21 Each committee would then have to review itself 22 periodically against these criteria and provide the results 23 of the evaluation to the Commission. They did not define 24 periodically. I would anticipate that it would probably be 25 whenever you brief the Commission, at least annually, but we [T
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290 1- could get that further clarified.
.jf L 2 There are short little bullets there on some
( 3 criteria that some. staff put together. In essence, this is. 4 just four little short and sweet things. 5 Does the staff and the ACMUI interact in such a 6 manner as to satisfactorily solve issues before the 7 committee? 8 Do the committee members provide timely, useful 9 information to.the staff when requested? 10 Does the committee provide expertise and advice 11 which is not available.from within the agency? 12 Does the committee meet frequently enough to 13 address issues in a timely manner? Are any changes needed 14 to the meeting frequency?
) 15 These are four items that the staff has come up 16 with, so we need your thoughts on those, any changes, 17 additions, anything else you would rather see to be used as 18 criteria.
19 CHAIRMAN STITT: Dennis? 20 DR. SWANSON: A couple comments. First of all, do 21 these four issues address what the staff considers to be the 22 value of the advisory committee? 23 I mean, to me, you people ought to be saying, you 24 know, what is our value to you and is that what is reflected 25 in these four things, and is there anything else, okay?
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291 1 MS. HANEY: I think that's got it covered. 2 DR. SWANSON: Okay. A specific comment on the 3 first one, does the staff and the ACMUI interact in such a 4 manner as to satisfactorily solve issues, I don't think 5 we've ever solved anything in this committee, okay? Maybe 6 satisfactorily address issues before the committee might be 7 a better statement there, okay? 8 I think another role that this committee does, it 9 brings to the. medical staff issues of concern from the 10 regulated committee, and somehow that needs to be reflected 11 in those criteria. I mean, are we' adequately bringing to 12 you as medical staff issues of concern of the regulated 13 community. Respondent 14 MS. TAYLOR: And that would probably fall under () 15 16 the third bullet, provide expertise and advice which is not available. 17 DR. SWANSON: Yes. Although fundamentally, I have 18 a function here, you know, I represent the radiopharmacy 19 community, okay, and I have a responsibility to them, okay, 20 also, and somehow that responsibility ought to be reflected 21 in those requirements also, I think. 22 DR. WILLIAMSON: Maybe another way to put it is we 23 provide critical review and oversight of some of your 24 initiatives that are brought before us, sort of reaction 25- from the public or the regulated community, and are we doing /~ ANN RILEY & ASSOCIATES, LTD. (_') . Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
292 l 1 a L good j ob. If we said yes to everything you said, maybe , ~Y 2 you might be happy, but - - l 3 MS. HANEY: It would make my life easier, Jeff. 4 DR. WILLIAMSON: -- but I don't that you are 5 getting sort of a tempering - - 6 MS. HANEY: That's fine. 7 DR. WILLIAMSON: In reality, you maybe perhaps 8 don't win on very many points, you know; nonetheless, I 9 think that it's probably a valuable process for all 10 concerned. 11 DR. PAPERIELLO: You help us define issues. I 12 mean, in science, asking the right question is the first 13 step in getting the right answer. 14 CHAIRMAN STITT: Other comments? Go ahead. 15 DR. ALAZRAKI: I think that the Nuclear Regulatory (} 16 Commission and the regulated communities, and I'll speak l 17- from the perspective of nuclear medicine, have a long 18 history which has been not a very happy history, and much of i 19 that dissatisfaction for many years in the regulated l 20 community really stemmed frem a lack of communication where 21 NRC regulated this community but did not communicate at all 22 with it, did not ask its advice. If there was - - I think 23 there was ACMUI, but they hardly ever met. 24 So I think right now, in the current few years 25 that ACMUI has been functioning with NRC in a substantive l-O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 , Washington, D.C. 20005 i (202) 842-0034 L _____ _ .z_--__---___----_-__--- --- .-- - - - - - - - - - - -
293 l 1 way, the dissatisfactions in the regulated community that I
/N 2 know has been much less - - I mean, there still are some, 3 but much less than in prior years. So one of the things 4 that ACMUI does for NRC is communicate well enough so that {
l 5 the regulated community understands better what NRC is about 6 and NRC understands better what the regulated community's 7 concerns really are, and I think that this committee bridges 8 that previous gap very well. l 9 CHAIRMAN STITT: Other comments? Very nicely put. 10 DR. ZOON: I would just like to recommend possibly i i 11 one more bullet, and that is an assessment of how successful I 12 this committee's recommendations are in terms of being j 13 accepted by the NRC. 14 DR. SWANSON: We've already travelled that ground. 1
\ 15 We failed miserably.
[I 16 CHAIRMAN STITT: We've already seen that for our 17 meeting here. Cathy reported back - - each time we have a 18 meeting now, we get a little bit of a report card, if you 19 could call it that, on what we had said the last time, what 20 the responses were, and so we're hearing it back, and, you 21 know, we don't have to like what we hear, we're at least 22 hearing back, and that's a real change. 23 DR. WILLIAMSON: No , I think that's all true, and 24 I don't think that the comment disputes that. But as one of 25 the sort of formal self- evaluation measures, it might be 1
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294 1 - sort of useful as one of the benchmarks to what extent are
} 2 we, you know, influencing or moderating the agency's 3 initiatives.
4 MS. TAYLOR: I think it's a good idea because it 5 formalizes the-process, and it makes sure that we don't 6 backslide. 7 CHAIRMAN STITT: And it is the process that we're 8 engaged in, so we can - - can you make some nice words, 9 Torre, to make that a bullet? 10 MS. TAYLOR: We'll come up with something and 11 we'll send it to you all, of course. 12 CHAIRMAN STITT: I know you will. 13 MS. TAYLOR: Well, I don't know if I'll be working 14 on this, but somebody will be. 15 CHAIRMAN STITT: Okay, l 16 Torre, do you have other - - those are all the 17 criteria? 18 MS. TAYLOR: That's it. 19 CHAIRMAN STITT: Okay. Anything else from the 20 committee on these points? 21 MS. TAYLOR: And once again, we will put the f l 22 criteria together in a formal memo to Dr. Stitt and ask for 23 the committee's final loview and Dr. Stitt's signature, and 24 then we'll transmit that to the Commission. 25 MS. HANEY: Torre, do you remember the due date O ANN RILEY & ASSOCIATES, LTD. 1250 I Street, N.W., Suite 300 Court Reporters ( Washington, D.C. 20005 1 1 , (202) 842-0034 l
295 1 for this?
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2 MS. TAYLOR: I researched that the best I could 3 initially, and I didn't really see one. 4 MS. HANEY: Because I think you should be seeing 5 something relatively soon. If my memory serves me right, 6 it's near- term. 7 MS. TAYLOR: Well, I didn't get to talk to you 8 this week about it, and what did I-did find was at the end 9 of it, ACMUI has a suspense date of one year after final i 10 decision on medical program, and I didn't know exactly how l 11 that tied into all of this. 12 MS. HANEY: Okay. You just jogged my memory here. 13 MS. TAYLOR: Does that help? That's why -- , 14 MS. HANEY: Yes, but not for this decision. I (\.
\s,/ 15 MS. TAYLOR: That's why I didn't discuss the due '
l 16 dates, because I wasn't really sure. ; 17 DR. SWANSON: Which decision? 18 MS. HANEY: The one whether I stay here and type 19 this tonight so you guys can bless it tomorrow morning or 20 not. It does have a relatively quick time frame, so you l 21 should be seeing something like within the next two weeks or 22 so. 23' CHAIRMAN STITT: All right. Are we done with q
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24 business for today? The schedule calls for us to meet at 25 eight tomorrow morning. There are five points of today's l (q,/ . ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1250 I Street, N.W., Suite 300 ! Washington, D.C. 20005 (202) 842-0034 l l
296 I agenda we did not get to today. \ 2 What other housekeeping do we have to do? i 3 MS. HANEY: Go off the record? l l 4 CHAIRMAN STITT: Yes, we better go off the record. l ! 5 (Whereupon, at 5:09 p.m., the meeting was l 6 recessed, to' reconvene at 8:00 a.m., Monday, March 2, 1998.] 7 8 9 10 ) l 11 12 1 13 14 16 ) i 17 18 19 20 21 22 1 23 1 24 ) i 25 l
;/w ANN RILEY & ASSOCIATES, LTD.
(~ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
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REPORTER'S CERTIFICATE This is to certify that the attached proceedings p before the United States Nuclear Regulatory Commission in V . i the matter of: NAME OF PROCEEDING: MARCH ACMUI MEETING ; DOCKET NUMBER:
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i PLACE OF PROCEEDING: Rockville, MD I l were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to l typewriting by me or under the direction of the court
; reporting company, and that the transcript is a true and
- curate record of the foregoing proceedings.
l A Mark Mahoney Official Reporter Ann Riley & Associates, Ltd. O
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