ML20196D871
| ML20196D871 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/1998 |
| From: | NRC |
| To: | |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 ASB-300-503, NUDOCS 9812020345 | |
| Download: ML20196D871 (260) | |
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l l 1 , i 1- UNITED STATES OF AMERICA ()
,2-2 NUCLEAR REGULATORY COMMISSION 3 ***
I
- 4. PUBLIC MEETING: PROPOSED REVISION OF RART 35 AND THE i 5 NRC'S MEDICAL POLICY STATEMENT l
-6 I 7 NRC-Headquarters .
l- !
- 8. Two White Flint North ,
. .9 Auditoriam- (Level P-2)
I 10' 11545 Rockville Pike j r
.;11 Rockville, MD 12 a
- 13. Wednesday, October 21, 1998 ,
I 1<4 '. A O s- 15' The above-entitled meeting commenced, pursuant.to 16, notice, at-8:30 a.m. ! l 17 ' i 18 .
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. ANN RILEY'& ASSOCIATES, LTD.
Court Reporters I l l
- .1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036
;,. (202)J 842-0034 L
l
2 I
,_s 1 PROCEEDINGS k_ 2 [9:08 a.m.]
3- MR. CAMERON: Good morning, everybody. We're l 4 going to get started with our session. l j 5 My name is Chip Cameron. I'm the special counsel J 6 for public liairon in the Office of General Counsel at the 7 Nuclear Regulatory Commission, and it's my pleasure to serve 8 as your facilitator today. ) 9 I would like to welcome all of you and to thank
. 10 all of yciu for taking the time to participate.
11 As you can see from the participant list, the 12 people sround the table, we have lots of expertise and l 13 experience here today and I look forward to a productive g 14 discussion of the issues. In a few minutes, we'will go V'~') 15 around the table and introduce ourselves to one another. 16 The focus of the discussion is going to be on the 17 people around the table, but we are going to go out to the 18 audience after each discussion topic and get audience
'19 comments.
20- For those of you at the table, when you want to 21- -talk, place your name tent up like this. The reason we have 22 a break here is because there's always a lot of name tents
. 23 that end up in the well. We've also found tires, copies of 24 the IOM report. But put your name tent up and I will 25 identify you, and this will relieve you of the burden of U ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
. Washington, D.C. 20036 l (202) 842-0034 L
3
~ 1L Ltrying to keep your hand up all the time. ~
It also allows us
) 2 to get a clean transcript. We are transcribing the meeting.
i l 3 The court reporter will have your names, so that 4' you won't have to repeat your name as we go-along. You can p 5 just talk. .For those of you out in the audience, you have 6 'two choices, three choices really. You can come up to ( 7 either one of these' microphones, and, again, state your name 8 .and' affiliation, if appropriate, or we do have a talking 9 stick. So I will be walking around with that, if you want
- 10- to stay where you are in the audience.
'11 One of the things that I'm going to try to assist 12 you with during the next two days is to help keep the 13 discussion focused and relevant and we may b.e able to find a 14 seat for you up here somewhere. 1 L J['N
!Ts-). 15' Now, I may not take all of the name tents that are j 16 up in sequence, if we need to follow a particular thread of 17- , discussion that's going on. But we.will get to all of you
- 18 who want to speak. For. ideas that may not fit into the I
19 discussion at a particular point, we're going to put them i l L 20 over'here in a pa'ddock and we will make sure that we get to ! 21 those items somewhere in the agenda'over the.next two days. l 22 . I would ask that only one person speak at a time, p 23 so that we can hear what that person has to say. l l L- _24 We have a lot of items to cover and we have a lot L 25. of people around the table, but I would also ask you to be , 'N ANN-RILEY & ASSOCIATES, LTD. ()' Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 , f Washington, D.C. 20036 i ! (202) 842-0034 L 1
4 1 as concise as possible. We do want to develop the .O .( ) 2 discussion threads, because indeed that's why we are meeting 3 in a workshop format like this, but there may be some times 4 when we have to move on to other participants or other 5 topics. 6 Hopefully, when we do have to move on, if anybody 7 still has a comment or a question, we'll get that on the 8 record at some point or we'll discuss it off-line, so to 9 speak, during the breaks. I would just remind everybody 10 that this is not just an opportunity to talk to the NRC 11 staff, but for all of you to talk with each other about 12 these particular issues and make sure that you've gotten a 13 hold of the NRC staff during the break 6 and after the 14 meeting, if there are topics to discuss. k_) 15 Now, as most of you know, the NRC held workshops 16 similar to this on the development of the proposed rule and 17 the purpose of those workshops was to explore, with the 18 broad spectrum of interests represented around the table 19 today, how and why Part 35 should be changed. 20 Now, the staff and the Commission considered those 21 comments in preparing the proposed rule that was published 22 in the Federal Register. 23 Many of you may feel that the Commission did not 24 adopt the correct position on the various provisions in the 25 proposed rule, perhaps we didn't go far enough, perhaps we (c) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
5 1 didn't establish a sufficient rationale for the positions () 2 3 that-are represented in the proposed rule, or that we didn't sufficiently explain something. 4 Of course,-there may be those who are satisfied 5 with the particular provisions in the proposed rule. 6 Well, this workshop is an opportunity to focus on 7 a specific Commission proposal rather than broad rule-making 8 issues at this point and we want to hear your views on the 9 provisions of the proposed rule. Should they be modified? 2 i 10- More itaportantly, perhaps, why or why not? What's the 11 ratior. ale for modifying a particular provision? ! 12 Does a particular provision fulfill the objective. 13 behind it? Does it meet the intent of the Commission in '
.14 that particular provision? Is there another way to do it' '
) 15 that may be less onerous or more effective, and do we have 16 enough data to support the provisions in the proposed rule?
17 I just want to finish off with a few general
.18 thoughts on the agenda for the next two days. This is the ,
19 third workshop that we have held. We had the first one in '
'20 San Francisco, the second one in Kansas City, and what we've 21 been-trying to do is we have been trying to build on each 22 session and to modify the agendas accordingly.
23 In San Francisco, we looked at what I call the 24 underpinnings of the proposed rule, the risk basis and, I 25 think, compliance costs, the issues of whether there are I' ANN RILEY & ASSOCIATES, LTD.
\- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 f
6 1 voluntary industry standards that might be used instead of (. i,
)4 2 NRC regulations, and we covered these topics in Kansas City, 3 but we also gave attention to a proposal that was developed 4 by at least a segment of the medical community on how the 5 accreditation process might be used to ultimately supplement 6 the NRC inspection process.
7 We are going to have a presentation on that topic 8 again tomorrow. We also gave more attention to inspection 9 issues in Kan-ws City. Now, for this session, we're going I 10 to revisit the proposal, as I mentioned, from the medical l 11 community on the use of accreditation programs. That's ; 12 . going to be in our 1:00 session tomorrow on the implications j 13 of professional standards and economic factors for the 14 proposed rules regulatory framework. I i ( ,/ ' 15 In that regard, we're going to discuss one aspect 16 of the draft medical policy statement that talks about the 17 use of voluntary industry standards. We also have
]
18 representatives here for that session from the Joint l 19 Commission on the Accreditation of Health Care Organizations 20 and also from the Health Care Finance Administration, who 21 will be assisting us in understanding what the implications 22 of their programs might be for the Part 35 regulatory 23 framework. 24 Now, the last session tomorrow is going to be on 25 -what we're calling performance-based rule issues and we're (' ' ' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
7 ' 1 going to go through a couple of examples of that and Mary,
]) b
~2 Ann Dell from'Capintech is going to be here to sort of give
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3- us some information to lead off that discussion. 4 Another highlight of the meeting is a discussion ! 5 of the provisions in the proposed rule about training and R l 6 experience and we.have a special session tomorrow on the 7 provision in the proposed rule that deals with the NRC's 8 approval of certifying organizations and examination j 9 providers, and we're going to bring up about seven or eight 10_ people from the boards. I'm not sure where we're going to 11 put'them yet, but we'll work on that before tomorrow. 12 But we're going to focus that discussion on that I 13 panel. We also want to get comments from you on that issue, 14 but we really want to hear from the boards on that '() 15 particular topic. 16 Finally, we're going to revisit the risk issue 17 again today. As you know, the Commission has emphasized, E18 ' not only in this rule, but generally, that our regulatory 19 actions should be risk-informed and we're going to have a 20 discussion of that later on this morning, I believe at 21 10:45, and Don Cool is going to give us a little bit of a
'22- summary about what the staff and the Commission looked at in 23 . terms of risk information for this rule and we're also going 24 to hear from Dr. Carol'Marcus of the nuclear medicine 25 community and her comments on the risk basis for the L
L i. i h' Nu-ANN RILEY & ASSOCIATES, LTD. Court Reporters , 1025 Connecticut Avenue, NW, Suite 1014 L Washington, D.C. 20036 L (202) 842-0034 ') l
. . ~ -- . .
8 1 proposed rule. l3
\s ,) 2 Now, . in our discussions about risk and everything 3 else, I would just ask you that you try to key your comments 1
4 to specific actions that the Commission might take in regard 5 to the proposed rule. In other words, you may not like the 6 approach that was taken in a particular area, but if you 7 could focus in on what should be changed in the proposed 8 rule or in the regulatory guidance that we have or what 9 actions the Commission could take to try to satisfy your 10 concerns, I think that would be helpful. 11 We're going to go around for an introduction in a 12 few minutes, but we're fortunate to have Hugh Thompson, who 13 is the Deputy Executive Director for Operations for this l 7- 14 particular area, to give us some opening remarks. Hugh, I 15 think, is going to be able to stay with us for at least 16 parts of the agenda to listen to some of your comments. 17 So let's go to Hugh and then we'll go to 18 participant introduction. 19 MR. THOMPSON: Thanks, Chip. Giving welcoming and 1 20 opening remarks were kind of exciting for me and then all of ! 21 a sudden Chip said he would want to make a few remarks, and 22 he's covered everything. I should never follow Chip on 23 this. 24 But in any event, I really do welcome all of you i 25 here today. I do have some prepared remarks, which I will l l I (/',)s ANN RILEY & ASSOCIATES, LTD. 1 Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
l3 __ 9 - 1 -probably now not us'e. But.there are a couple of things that I h 2 we really do want to focus on. L.) 3 One of those things deals with the importance of-
'4 this activity, the commitment that the Commission has to 5 having these workshops. As you probably recall, we do 6 numerous rule-makings day in and day out and this is one of 7 the most extensive efforts we've had to really engage the 8 stakeholders in the rule-making activities. It's actually 9 .the licensees, the other states, the participants, members 10 of.the public activities, and this is almost the most 11 extensive effort that I' recall.
'12 I can also tell you that it clearly is an area 13 . where there are lots of controversial issues. There is not 14 a consensus that's going to be developed on all issues. If-b 15- there is a consensus, then that's going to be terrific. If 16 .there is not a consensus, I think it's important that the
-17 options are articulated, the basis for the various positions 18 are articulated,'so that we represent to the Commission the 19- range from all the participants that we receive from these
- 20. public workshops and we will present those options to the 21 ~ Commission for a final decision.
22 - The Commission obviously is paying a lot of
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23 attention. They gave the staff a lot of clear guidance as 24 to'what they want to do. They're following the results of 25 these workshops very carefully. This area is one which I h
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ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
.. . . - .- - . . ~ . - . . -
10 1 1 can tell you the Commission probably has received more j (m) s 2 Congressional correspondence than any other rule-making that 3 I have been involved with in my 25 years with the Nuclear 4 Regulatory Commission. 5 So it's not the lack of any interest on the 6 Commission's part., it's not the lack of any interest. I 7 t1 ink, though, that there are areas where there are varying 8 views and' varying positions that will be required to do 9 that. I plan to be here as much as I can today to listen to 10 the discussions. I think that the issues are going to be 11 very iaportant. 12 It kind of reminds me of the old -- the elephant 13 was very tired and cumbersome and felt gray and unhappy in
,.-~.
14 his role in life and he was walking around through the (_) 15 jungle and then he decided he wanted change. So he went to 16 the owl and he said, "You know, I'm really just tired and 17 I'm heavy and I really want to change to be something 18 beautiful." The owl looked at him and said, "Well, you 19 should become a butterfly, light and pretty and fly around 20 and flit around." 21 So the elephant troughed off back into the jungle 22 and two weeks later came back to the owl and he says "How do 23 you become a butterfly?" The owl says, "Look, I just make 21 policy. You have to implement." 25 So welcome to the owls. You are now part of the -(n' 'f ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 [ Washington, D.C. 20036 i (202) 842-0034
11 1 owls. You are here to help us make policy today and if we (_) 2 can come up with any butterflies, it will be delightful, and 3 if we all stay elephants, then that's just our problem. 4 So with that, I do appreciate your participation. 5 This is probably one of the most august groups that we could 6 assemble and I look~really forward to the discussions-today. 7 So, Chip, back to you. 8 MR. CAMERON: Thanks, Hugh. I was going to use 9 that elephant-butterfly joke. I 10 MR. THOMPSON: I get first there. 11 MR. CAMERON: That's right. Well, let's start to 12 get to know one another and go around the table for 1 13 introductions. What I'd like you to do is just, of course, i 14 give us your name and any affiliation that you think is 1
- g .)
'-' 15 appropriate and also one or two issues of concern that you
{ 16 have today about the proposed rule. j 17- Let's start off with Dr. Don Cool. 18 MR. COOL: Good morning. Don Cool, I am the 19 Director of the Division of Industrial Medical Nuclear 20 Safety and, by virtue of that position, end up being the one 21 who uill have to implement it sooner or later after Mr. 22 Thompson and others conclude what it is that we are supposed 23- to be pretty and look like. 24 With that, in essence, one way of looking at my 25 interests are merely multitudinous and I could spend the -,n\
\ ,) ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
( 12 [ 1 entire rest of today. Certainly I have a keen interest both 1 l :p .
.(r '2 in'the rule-making, moving forward with trying to get a
- 3 clear' set of' expectations, requirements and issues. -
l -4 I think one of the things that I would like to l ! 5 specifically request from you is your specific suggestions ! 6 for areas of change, modification, addition or deletion, i 7 including the rationales and reasons, but positive or l i 8' negative;.if it's n'ot to be included, why; if it's not to be 9 included, if it's to be deleted or modified, why. 10 Because one of the things that will come back to 11 my group in the end as we attempt to put this together is to l 12 explain both to ourselves and to everyone, yourselves and 13 all others who will look at this package in the end, the I 14 reasons why we have done what we have done.
.i .(/ ' 15 Second, there are a number of specific issues and l
16- we are going to'have an opportunity address most of those at 17 points during the discussion today, where we have some l 18 opportunities to talk.about possible new ways to' deal with 19 certain aspects, new ways ~to look at possible training and 20 experience certification use of examinations typical within l 21 the industry, but which the Commission itself has not used; 1 l 22 some issues that have arisen through some of the workshops l- 23 with regard to potentials for accreditation and other
-24 programs that may be very useful in helping us look at
( 25~ alternative ways related to inspection and enforcement, an Ep Q ANN RILEY & ASSOCIATES, LTD. Court Reporters ,- 1025 Connecticut Avenue, NW,. Suite 1014 (~ ~ Washington, D.C. 20036 l (202) 842-0034 I
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1 area which the Commission and the staff is very interested t i i (_/ 2 in right now as we take an overall look at all of our - 3 programs; not just the medical arena, but all of the arenas 4 that I am responsible for, which other areas of the 5 Commission are responsible for, for trying to find both 6 ' efficiencies, effective ways, and to improve simply the way 7 in which we do business. 8 If we can accomplish even a small percentage of 9 that, I think we will have done extremely well today. 10 MR. WHYTE: Good morning. I'm Dr. John Whyte and 11 I'm in the coverage and analysis group at the Health Care 12 Financing Administration. We don't actually have any 13 particular issues that we want to raise. I view our role i t
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14 here more as a resource, to answer questions that you may i
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15 have, to provide information on issues such as some of our ] 1 16 payment policies, such as some of our regulatory policies, ' ! 17 like the conditions of participation for nuclear medicine j 18 services. _19 So basically myself and Sharon Hippler, who is ; 20 also going to talk, are basically here to provide any 21 information all of you may need. 22 - MR. CAMERON: Thanks, John, and thanks for coming 23 down, too. 12 4 MR. NAG: I'm Subir Nag. I'm President of the 25 American Brachytherapy Society and I'm representing the
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()N ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
14 1 society. I'm also at Ohio State. University and we will be s 2 addressing a lot of the issues in 10 CFR 35 in regard to 3 ' admissions, including new emerging technologies and so
'4 forth.
C 5 MS. MOORE: Marleen Moore. I'm a medical 6! -physicist and radiation safety officer at Fletcher Allen
- 7. Health Care, which is at the. University of Vermont. I'm i 8 here officially representing Fletcher Allen Health Care, and 9- unoffic'ially representing a number of the licensees in-the 10- State of Vermont, which is still an NRC state.
11 MR. CAMERON: Thanks, Marleen. 12 MS. FOX: Marleen,-that was short. I'm going to 1 13 -look forward to sitting next-to you. 14 My name is Mary Fox and I'm representing the 15, American Association of Physicists and Medicine. I do have 16, two issues that I would like to have for. discussion. 17; My most pressing issues are' going to be covered in 18l the agenda, so I will go to the next one, which is I think 19
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in all these revisions, it's a good idea to revise these
- 20' regs, but some of the things have not been changed. I'd 121 like to see us look at survey meters, do we have to 22 calibrate them once a year. I think that's too often.
23- Also, same thing with leak testing. I don't think 24' the tests should be every six months. I'd like to see that 25 increase. b \- ANN.RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 j.
15 1 I had another issue that I wanted to share that we
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( ,/ 2 talk about. That's all one issue, survey meters and leak 3 tests. 4 I would like to officially go on record to request 5 -- the AAPM would like to see the comment period extended. 6 I've been told that that is probably not going to happen, 7 but I want to go on record and say that this has been a 8 major, major revision and there's lots of stuff to study 9 here. 10 Some of the people that I've talked to are really 11 just becoming aware that these regulations have changed so 12 much and it's such a major revision, I'd like to see the 13 comment period extended. , l fy 14 MR. CAMERON: Thanks, Mary. I'm sure that other I ( )
l 15 people might second and third and fourth that later on. 1 16 Paul?
17 MR. EARLY: My name is Paul Early. I'm a medical 18 physicist and president of a consulting group called 19 Associates in Medical Physics, headquartered in Cleveland. ! 20 I have issues regarding the radiation safety 21 committee, bioassays, some of the concerns will be voiced in 22 this workshop. 23 MR. CAMERON: Thanks Paul. Roy? 24 MR. BROWN: I'm Roy Brown. I'm director of 25 regulatory compliance for Mallinckrodt in St. Louis. I'm l i C ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
16
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1- 'here today representing CORAR, the Council on Radionuclides
- 2 and,Radiopharmaceuticals. I'm chairman of our committee on 3 Part 35 revision.
4 A couple of comments to start off with, the first 5 comment in the area of risk assessment. We feel that there 6 really has not been an adequate risk assessment' performed on ' 7 the use of radioactive materials in medicine. 8 We feel that risk assessment should be completed 9 before -- should have been completed before a draft rule was 10 written and that has not been done. 11 We also feel that a risk assessment needs to be 12 done at this point and shared with the regulated community 13 before we go any further in the rule-making process. We 14 feel that it was very clear in the SRM that this rule was O 15 supposed to be a risk-informed, performance-based study and 16 we really question how that can be done when an adequate 17 risk assessment really has not been done yet. 11B .The second point is the accreditation program. 19 .This came up in San Francisco and then was presented in
-20 Kansas City and will be presented again, I guess, tomorrow.
21 This is something we're very enthusiastic about. We feel 22 that an accreditation program like this can be very, very 23 effective and possibly serve to replace some of the NRC 24 inspections. 25 Thank you. f(ms)/ ANN RILEY & ASSOCIATES, LTD, j Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 , (202) 842-0034 m
{ 17 1 MR. CAMERON: Thanks, Roy. We will specifically f%. ( ,) 2 discuss both of those items on the agenda for the workshop. 3 Mickey? 4 MS. CLARKE: I'm Mickey Clarke. I'm a nuclear 5 medicine technologist at Washington University in St. Louis 6 and representing the Society of Nuclear Medicine 7 Technologist section. I, like Roy, am concerned about the 8 lack of a comprehensive risk analysis. I'm also concerned 9 about the so-called Scientech study that's out there, the 10 results of which have either not been completed or analysis 11 uncompleted, and never discussed in the rule-making 12 workshops. 13 jut. CAMERON: Thanks, Mickey. Carol?
- 14 MS. MARCUS: I'm Carol Marcus. I'm a nuclear k- 15 medicine physician at Harvard-UCLA Medical Center. I am 16 here as one of the representatives of the Society of Nuclear 17 Medicine and the American College of Nuclear Physicians.
18 I share the concerns that Mickey and Roy have just 19 mentioned. I would like to add a few others. 20 We're concerned about this new interpretation of 21 the Atomic Energy Act, in which the NRC now says it has 22 responsibility for patient radiation safety and we are 23- concerned with where that leads. 24 We are concerned also with dual regulation, a 25 large amount of dual regulation which appears in this new
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3 Q ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842 r034
18 1 Part 35, and a concern that much of the regulation seems to
.s,o)
I 2 be an exercise to exterminate human error as though if you 3 had enough regulation and license conditions, human error 4 would go away. 5 And human error has nothing to do with regulation 6 or license conditions and the purpose of many of these 7 requirements does not seem clear to us, because it doesn't 8 seem that you will get anything of value from it. 9 MR. CAMERON: Carol, can I just ask you to clarify 10 one thing? When you say dual regulation, what exactly did 11 you mean by that? ' 12 MS. MARCUS: There are primary regulators of the 13 practices of medicine and pharmacy, of health care quality, 14 of drugs, of worker safety. FDA has a very, very extensive q kl s 15 role with drugs and research with drugs. There are over 50 16 boards of medicine and pharmacy, because many of our 17 territories have them too, that look.at professional 18 practice relative to accepted standards of practice and we 19 have JCAHO, which looks at the quality of practice at health 20 care institutions. 21 We have professional quality assurance programs. 22 We have many groups that work at medical quality and medical 23 safety and when the NRC dual-regulates in that area, as you 24 will see with my risk talk, the second regulator doesn't get 25 any of the credit because that's taken by the first es ( ) ANN RILEY & ASSOCIATES, LTD.
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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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h ' bu44 19 1 Lregulator, if it does any good, but it costs a l'ot of money
~
'2 .and'that'in and of itself becomes.a problem.
!3 The last thing I can mention is that the cost 4 analysis for this rule is way off base. We're dealing with
- 51 something that's costing hundreds of millions of dollars a
- 6 ' year.
7 MR. CAMERON: Thanks for that~ clarification. 8 Shelby?,
'9 MS. DUNSTER: I'm Shelby Dunster, an associate 10' director'at the-Joint Commission on Accreditation for Health 3 s
11 Care Organizations, in the-department of standards.
. .12 - Probably somewhat like Dr. Whyte from HCFA, I am here as a 13 resource to answer any questions and also to sort of keep my
.14 ~ ears open for any points of converging interests between the 15 NRC and the Joint Commission in terms of our mission.
16 MR. CAMERON: Thank you. Again, as with the 17 Health Care Finance Administration,.we appreciate the fact 18 that the' Joint Commission sent someone down to serve as a-19 ~ resource.for us, for this wor): shop. 4 ' 20 Bob? 21'
~
MR. ZOON: Yes, I'm Bob Zoon. I'm the RSO and 22 i director of the radiation safety program at the National 231 ' Institutes of Health, here in Bethesda, and in my capacity 24 ' today, I'm representing the Health Physics Society. L25 The executive board and science board of the i ANN RILEY & ASSOCIATES, LTD. Court Reporters
'1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C'. 20036 (202)'842-0034 . i -. - . - . . 1--' . . . . . . . . . . -
20 1 society met briefly on Saturday to discuss this issue and we I
) 2 have about three main areas of concern.
3 One is the prescriptiveness within the regulation, 4 especially regarding radiation safety training areas and in 5 the prescription of detailed procedures. 6 I also think that there is -- we also think that 7 there is a lot of unnecessary duplicative overlap with the 8 requirements of Part 20, which, in our opinion, sufficiently 9 ensures the safety of employees, the public and the 10 environment. 11 The Society also wants to go on the record as 12 saying there is insufficient comment time for this large 13 regulation. We'd like to see it extended. 14 MR. CAMERON: Thanks, Bob. Terry?
=
(m, 15 MR. JOHNSON: I'm Terry Johnson. I am the 16 radiation safety officer at George Washington University. 17 I'm a member of the board of directors of the recently 18 established radiation safety officers section of the Health 19 Physics Society. 20 I have a lot of concerns and I could enumerate 21 them now, but I really feel'the most overriding one is the 22- speed with which this is going. 23 Now, I understand that the NRC, at this juncture, 24 is poised to summarize what they have gleaned from this 25 meeting and the two prior meetings elsewhere in the country m-('~') ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 " Washington, D.C. 20036 (202) 842-0034
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- 11 and-ACMUI meetings and other formats of that type. i f 2 What I would'suggest is that the NRC go ahead and p 3 do'that, but publish it as another proposed rule rather than h '
4 final. I think that would satisfy the remarks of some of
^5 the other members that have said an extension is in order.
6- In fact, I think it will satisfy it much better, because 7 often what the NRC does in rule-makings that are so broad as
- 8. this is they, in responding to various comments'for their I L 9- own-internal desires and changes, they go off in a new L
.y.-
10 direction.that has its own problems. 4 11 So often;even though comments of the attendees of 12 a meeting like this may be given very heavy weight in the 13 final ~ result,'the final result may still have very, very
,f_
14 serious problems, and I would~ recommend that another ib 15, proposed rule be published.
'16 BUR. CAMERON: Thanks, Terry. I guess that raises 4
17 the issue of when do you need, for various purposes, to 18 achieve closure on a particular effort. We will get to 19 that.
'20- 'MR. JOHNSON: I'd like to comment on that.
21 Anything of this magnitude has not been attempted since 1986
- 22 , with regard to Part 35. So this is essentially a once per 23 12-year occurrence that regulatory changes of this magnitude i 224- are even proposed by the NRC, and I think that it deserves l 1
25_ very careful attention. l lj%; i jh;3/ ANN RILEY & ASSOCIATES, LTD. i Court Reporters.
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22 { 1- MR. CAMERON: Good. Thank you very much. Jim?
) 2- MR. DEYE: I'm Jim Deye. I'm director of medical 3 physics at INOVA Health Systems, over in Northern Virginia, 4 Fairfax Hospital and two other hospitals. Also, I have a 5 company of medical' physics consultants. I see that's what's 6 _under_my name,-so I guess that is what I'm representing.
7 Actually, I have a couple of concerns. The 8 primary concerns are on the agenda, with regard to training 9 and experience issues. I think there are some very 10 significant issues there that need development, 'but need to 11 be developed carefully. 12 The other is that we not in the process undermine 13 support for the existing radiation safety structure at 14 various level hospitals. I represent, as I said, I'm the h
\ss/ 15 RSO at1three different hospitals in our system and I know 16 .that the radiation safety committee has been a significant 17 underpinning of our program and if we're going to replace 18 -it, we need to replace it with something that works at all 19 : levels of health care, especially now that health care is 20 being driven more and more, like other industries, by the
~
21 bottom line. 22 - I know that I'm being challenged more and more by 23 hospital administrations to justify each and every action
- 24 that's taken in the context of radiation safety.
25 So I think we need that kind of support in any 4 7g () ANN RILEY & ASSOCIATES, LTD. Court Reporters I I 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 (202) 842-0034
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I 23 ; 1 ' program that comes out of these efforts. !'j l
\ 2 MR. CAMERON: Thank you, Jim. Steve?
3 MR. GAVITT: ' Steve Gavitt. I'm with the New York 4 State Department of Health. As a regulator, obviously we're { 5 interested in all of this and think a lot of these items are l 1
.6 covered.in the agenda. )
7 Two items that I'd like to see further discussion 1 8 are the accreditatien issue, as well as regulatory 9 evaluation of'the training providers and examination 10' providers. 11 Lastly,'also, I will concur with the timing of the i 12 -- or the time-frames for providing comments, that really 13 preserves more time to review and evaluate these regulations 14 or proposed regulations. ,0 A/ 15 MR. CAMERON: Okay. Thank you, Steve. Bill? ! 1 16' MR. VAN DECKER: I'm Bill Van Decker. I'm i
- 17. director of nuclear cardiology at Allegheny University r.
18 Hospitals-CP in Philadelphie.. I'm a member of the American 19' Society of' Nuclear Cardiology and I'm currently chairman of 20 the radiation safety committee for Allegheny University 21 -Hospitals in Philadelphia. 22 - I guess we're here with two major interests in the 23 rule-making process. Number one is our belief that a full L - 24 risk analysis would certainly show that diagnostic radio 25 tracers are extremely safe in patient care and, in that t
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( ANN RILEY & ASSOCIATES, LTD. Court Reporters
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Washington, D.C. 20036 (202) 842-0034 f~ l . _ , _ .
1 24 4 1 1 regard, there are a couple of corollaries that have us
,~,,
( ) 2 concerned. They are also extremely effective for patient 3 care and, therefore, we hope that the regulation of them and ! I 4 that the training, experience and testing reflect that low 5 risk situation. 6 We would especially like to reemphasize what other ! 7 people said. In the era of intense financial pressures, , 8 borne out no where more better right now that Allegheny in 9 Philadelphia, access for patient care is an important part 10 of this issue and that the regulations at all should not 11 cause increase costs or ease of use shift to potential 12 competing modalities, unless that is pushed by clinical 13 issues rather than the other issues involved. 14 The second portion of, obviously, our interests
,O,
(/ 15 are the training and experience issues. Obviously, these 16 are difficult questions in cross-cutting situations. There 17 is obviously a multitude of experience throughout the 18 medical care delivery system, with multiple specialties, 19 delivering procedures to patients, laminectomies by 20 arthopedists and/or surgeons, colonoscopies by GI physicians 21 and surgeons, suturing by ER docs and surgeons. 22 - So obviously some consensus on what it takes to 23 safely perform something, so that the defined bill of real 24 service is really that of the clinica.1 care to the patient, 25 defined by the patient's health outcomes and their personal [\-') ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
25 1 ' positions are_the most important part.
.r ) .2 MR. CAMERON: Okay. Thank you very much, _ Bill.
1 3 Let's go to Jim Fletcher. 4' MR. FLETCHER: Good morning. I'm Jim Fletcher, 5 from St. Louis. A lot of folks here from St. Louis this 6 morning,'it looks like. I was in the audience in Chicago ' 7 and I'm pleased to have the opportunity to be at the table 8 today with St. Louis University, St. Louis VA Medical Center 9 in St. Louis, where I am chief of nuclear medicine at the VA 10 and director of nuclear-medicine at the university, and 11 representing the Society of Nuclear Medicine today as the 12 president of the society. 13 I could say it's probably an advantage to be 11 4 three-quarters of the way around the table because you could I : 11 5 'just point to people and say I second that, I second that. 16 I really would second a number of things that have
- 17. been stated already. That is, the concern about the
- 1EF -inadequacy of the risk analysis and the~PR. The Society 19 believes that the level is really. inadequate. _There are 20 concerns that have already been expressed by Mickey Clarke 21 .about the' inadequacy of the Scientech document.
22 . The perspective that's missing from the.various 23 elements of the rule, that that could flavor the
.24 : ' record-keeping requirements, tha reporting requirements and 25 so on. It really -- it's hard to talk about the practice of \ ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
26 i 1 medicine without considering the risk issues and the 13 (_,/ 2 risk-benefit issues every day that's done and I think we 3 need to get back to that. 4 The second issue really is the speed at which
- 5. . things are moving and as others have indicated, we need to 6 slow the process down, consider very definitely an extension 7- for the period for comment.
8: MR. CAMERON: Thank you very much, Jim. Let's go 9 'to the Jim beside you. 10 MR. MARKS: Good morning. Jim Marks, radiation 11 oncologist from Mist-ari Baptist Medical Center, in St. 12 Louis, part of the BJC Health System. I represent the American College of Radiation Oncology. 14 Two issues that concern us are, one, that there
.A 15 'has been a dilution of the training and experience 16 requirements that govern the therapeutic use of isotopes.
17 Recall, under the previous rule,.that'you had to be 18 board-certified in our specialty to use isotopes 19l therapeutically. 20 Under.the current rule, you only need one instead 21 of three' years of formal training, plus an additional two 22 years under the supervision of an authorized user. 23 The second concern is that the intravascular use 24- of sealed isotopes remain under Part 35.490 that governs 25 brachytherapy and not be moved to emerging technology. A()' ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 L Washington, D.C. 20036 (202) 842-0034 _..-_m. . _ _ _ _ _ _ _ _ _ - - - - - - - -
27 1 We think.there needs to be a more clear definition
]
(, 2- of~ emerging technology, lest patient safety be affected. 3 Mk.' CAMERON: Thank you very much, Jim. We will 4- get to that emerging technology issue probably as part of 5 the training and experience requirements, although I realize 1 6 it's a broader issue. 7 .Aubrey? 8 MR. GODWIN: Aubrey Godwin, State of Arizona, the 9 radiation regulatory state, representing, I guess, part of L10 the agreement state group. If anybody can represent them, I
~
11 think I can. 12 .MR. THOMPSON: If anybody can, Aubrey, we'll let 13 you do it. 14 MR. GODWIN: Thank you. I appreciate that. So I O
\m l- 15' can disagree and go along.
16 I'd like to float a somewhat different concept. 17 It seems to me that -- well, going back in history just a 18 little bit, I remember when NRC and AEC tc d us, as 19 agreement states, that the authorized user had to select the 20 patient, prescribe the dose and interpret the results. Life 21 was real easy. You asked three questions, you had the 22 answers. 23 Fortunately things are moving on and I hope for 2
.4 the.better. It would seem to me that there are doses that 25 should begin from certain medical procedures where even if j~h A}'
ANN RILEY'& ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
28 1 you made a mistake, you really don't have any consequences. ( 2 This goes back to the risk. 3 It seems to me that current practice of nuclear 4 medicine is such that we can use the average physician, they 5 get a lot of training in interpreting results, why not go 6 ahead and say make them a GL user or just authorize people 7 to do it if the dose being delivered is below a certain 8 amount, go ahead and authorize them to do it. 9 Forget about keep trying to flip back and forth. O When it's above this particular dose, then you need a 11 particular physician who has particular training, and we can 12 argue about qualifications later, which I suspect we will 13 .anyway, f~ 14 Then you have a person that the agency or the
~/ 15 state or the government or whoever has reviewed their 16- qualification, know they qualify and they're making the 17 assessment of patients relative to the risk that's really 18 there.
19 The situations where the risk is small, you don't 20 have to worry about it. If the risk is high enough, then
-21 .they would be involved.
122 - Sort of a counter end to this is the studies out 23 of Chernobyl, the World Health Organization is looking
-24 toward a thyroid protection for children in the order of one L 25 ' rem, because they see close to doubling the-dose of thyroid ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l 29 l 1 1 cancer whenever you have a one rem ingested dose to the (,) 2 thyroid. I 3 So you have to look at what dose would turn out to 4 be relative to low risk, but somewhere in there I suspect 5 there should be plenty of procedures that can be done 6 without a whole lot of precedent here and clearly we can 7 establish things and let the general practice of medicine do 8 their business of practicing medicine. 9 MR. CAMERON: Thank you, Aubrey. 1 10 MR. COOPER: My name is David Cooper. I'm the 11 director of endocrinology at Sinai Hospital in Baltimore and ; 1 12 also director of the Johns Hopkins Hospital thyroid clinic. 13 I'm here as a member of the clinical initiatives committee 14 of the Endocrine Society. The Endocrine Society is a large l 7-
's- 15 group of scientists and physicians that deal with endocrine l
l 16 problens, obvicusly, and specifically our purpose here today l 17 is to talk about thyroid disease. ! l ( 18 Our main area of interest in this hearing is in l 19 the training and experience requirements that may be l 20 eliminated under the old rules and new requirements which j 21 have been proposed that will subsume the use of radioactive 22 iodine under a more broad category that will basically 23 eliminate perhaps the consideration previously that's been 24 given to endocrinologists to treat patients with 25 hyperthyroidism and thyroid cancer.
, (j ANN RILEY & ASSOCIATES, LTD.
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l 30 1 That's really the main focus of my being here j r' (,,)e 2 today. 3 MR. CAMERON: Thank you very much, David. Leslie? 4 MR. DeGROOT: My name is Leslie DeGroot. I am a 5 physician at the University of Chicago and represent the i 6 >American Thyroid Association. I have been personally ; 7 involved in using radioactive iodine for 46 years. 8 My interest is similar to Dave, Lefty Cooper's;
.9 that is, in making sure that tPe regulations that govern the I 10 use of radioactive iodine are appropriate for the use by 1
11 endocrinologists. The endocrinologist is the physician that { 12 diagnoses, cares for, treats, follows the patients with 13 thyroid disease and endocrinologists have been safely using )
- 14 radioisotopes for this for 50 years. I l
C~' s 15 It is inappropriate to lump regulations for this 16 . group with other medical uses just for regulatory 17 convenience, unless there is some other clear reason which 18 hasn't been displayed. , l 19 I wish to emphasize the importance of recognizing 20 the difference in training that's needed for different uses 21 of isotopes and emphasize that the point of the regulations 22 or any changes obviously should be to see whether they 23 improved or not the quality of patient care. 24 Thank you. !
~25 MR. CAMERON: Thanks, Leslie. I guess I should j /"' I
}s,)V 1 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i
- l. 31 !
1 ' explain before the meeting, David Cooper told us a story I) 2 about-being in grade school and all of the kids being asked - 3 for their nick names and he didn't have one. He was the i 4 only one who didn't have a nickname. So they made one up on - 5 the spur of the moment, which was Lefty. And I think before i 6 you leave here today, you will have a nickname. 7 Let's go to Jack. , 8 MR. RASKIN: 'I'm Jack Baskin. I'm in private 1 l l 9' practice. I'm past president of the American Association of I 10 Clinical Endocrinologists, a large organization of 3,500 ;
.11 practicing endocrinologists in the country.
12 We're concerned that we're changing a rule that 13 has been in effect for literally a half a century. We don't
,j- 14 know of any safety concerns from the use of this rule that i )
\ /- 15 we're aware of. It's worked well for endocrinologists.
)
It allows endocrinologists to continue treating 17 their own patients without referring them out to another l 18 specialist for treatment. This is good for the patient. It ; saves money. It's convenient for the patient, and it has 20 worked. ! 21 To change this and to unbraid the rule and put us 22 in the category of the people who are using other isotopes 23 is not our desire. We would.wish that we could maintain the 24 present rule of 9.32 and 9.34. We deal with one isotope, we 25 ' treat two diseases. This has not changed in the last 50 lC t ANN RILEY & ASSOCIATES, LTD. Court Reporters
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4 . a. 32 i 1 years. There is no developing technology and we don't see k._-) 2 any need~to require a change in this. l 3 MR. CAMERON: Thank you, Jack. Carlos? l 4 MR. HAMILTON: Thank you, Chip. I'm Carlos l 5 Hamilton. I'm a practicing physician in Housten, Texas. l 6 I'm on the faculty of Baylor College of Medicine. 7 I'm here today representing the American l 8 Association of Clinical Endocrinologists and the American 9 College of Endocrinology. You have just heard from my 10 colleagues here, we representing practicing physicians who 11 care for patients with thyroid disease. We are very 12 concerned and interested in the interests of our patients. 13 As you have'already heard, I-131 use in the
,e~g 14 treatment of thyroid disease was really the beginning of \ ') 15 nuclear medicine and the beginning of isotope use in l
16 clinical medicine. It led to an enormous understanding of ! l 17 the physiology of the thyroid gland, both in formal i 18 physiology and in disease. 19 Endocrinologists have been using I-131 for 50 20 years virtually without incident Our concern at this time 21 is two-fold. One is in providing the very highest quality 22 of health care to our patients and doing that in a 23 cost-effective way and then, secondly, establishing training 24 guidelines that will facilitate these parameters. l 25 It's a pleasure to be here. Thank you, Chip. (\ Ils ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
33 1 MR. CAMERON: Thanks, Carlos. Let's go to Sharon.
.y
( ,) 2 MS. HIPPLER: I am Sharon Hippler, of the Health 3 Care' Financing Administration in Baltimore and I'm here with 4 John Whyte to serve as an information resource for the 5_ Medicare program. 6, MR. CAMERON: Thanks, Sharon. Jennifer? 7 MS. BUCHOLTZ: Good morning. I'm Jennifer 8 Bucholtz. I'm representing the Oncology Nursing Society. . 9 For 14 years I was a c'inical nurse specialist for Johns 10 Hopkins. Hospital, in the division of radiation oncology. So 11 I do have a lot of firsthand experience taking care of 12 patients, with my iodine friends-and other colleagues that 13 are around the table.
,_q 14 I also was a member of the Institute of Medicine Ss 15 Review Committee for the NRC medical use program. I do have 16 a copy of that publication with me, so it's not under the 17 table.
j 18 But I do specifically want to press two points. I l 19 agree with Jim Deye, we have major concerns about 20 elimination of the radiation safety committee. This is.one 21 place that nurses do have a voice and are represented in 22 that radiation protection structure. 23 I'm also concerned about release of patients with 24 certain levels of radioactivity, as well as family 25 visitation rights, the two main issues that we would like to im (/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut. Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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P 34 r 1 address.
-2 MR. CAMERON: Good. Thank you very much,
) !
3 Jennifer. Cathy? 4 MS. HANEY: My name is Cathy H ney. I'm a section 5 leade,r in Don's division. I'm in the rule-making and 6 guidance development branch. .Primarily, I'm here today 7 because I was the chair of the Part 35 working group. My' 8- interests really-are getting the comments from the different 9 stak'eholders that are at the table, from the members of the ) 10 audience. , 11 We are very interested and you're welcome to talk 12 to me during the meeting, during breaks. Also, there are i 13 several members of the working group that are present in the ! 14 audience, so if you can't directly with me, and are e i m (A w)15 interested in just verbally addressing some of the comments, - 16 at least feel free to talk to members of the working group. i I 17 Thank'you. 18 MR. CAMERON: All right. Thanks, Cathy. Hugh, do 19 you want to int.roduce yourself again? 20 MR. THOMPSON: Yes. I'm still Hugh Thompson. The 21 two things that I am most interested in I think were really 1 1
.22 . identified by Terry. One of them is dealing with the 23 unintended consequences and it's really related to 24 inspection and enforcement.
25' I'have heard a lot of comment around the room 2 C ANN RILEY & ASSOCIATES, LTD. ' (ms)" Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 l Washington,.D.C. 20036 (202)'842-0034 j
'I I i 3
1 35 1 about why are we changing the rule. The rule -- obviously,
! ) 2 I guess I was involved in the rule, I know Dr. Marcus and I 3 had discussions about the rule for many years, and actually 4 I am almost encouraged to hear people wanting to continue 5 the current rule in place a little bit longer. I don't know 6 how much longer, but certainly a big longer.
7 But one of the things that we had when we put the ( 8 previous rule in place was the -- I don't think it thought 9 through the inspection and enforcement elements of it 10 carefully enough to make sure we had that understood. So l 11 that's one of the things I'm really interested in. That's l 12 probably the thing I'm most interested in, as well as with ! i 13 the understanding of how risk assessment and how you view I
,, 14 the elements of risk assessment, and I look forward to Dr. /
k_)T 15 Marcus' comments on that, as always. 16 MR. CAMERON: We are going to try to get into 17 Cathy Haney's segment on regulatory philosophy and a 18 comparative overview of the proposed rule before we take a 19 break. 20 MR. THOMPSON: I guess the other thing I'm 21 concerned about, I hope nobody in St. Louis gets sick today. 22 . MS. HANEY: The individuals that are at the table 23 have copies of the viewgraphs that I will be using there and 24 for those in the audience, there were copies out in the 25 lobby, if you'd like to follow along with what I'm talking i
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36
,s 1 about.
1
! \
k/ 2 What I would like to do is just take a couple of 3 minutes and go through some of the background of the rule 4 and what got us to this point, for those that have not been 5 as involved as others during the process. 6 My working group really got started with the staff 7 requirements memorandum, the direction from the Commission 8 to go ahead and start with the revision of Part 35. But as i 9 Hugh referenced, we've been talking about revising Part 35 10 for a very long time. 11 Some things that contributed to get us to the l 12' staff requirements memorandum viewpoint were some internal 13 audits that were done by NRC management, what was mentioned g) 14 earlier about the Institute of Medicine's report that came
\'~,/
15 to NRC a couple of years ago, and then also NRC's strategic 16 assessment and rebaselining efforts, and they took all those 17 things into consideration and really.came down with the SRM. 18 The SRM is what the Commission directed us to do, 19 and there are a couple of bullets here that I would like to 20 mention. One is to focus Part 35 on the procedures that 21 pose the highest risk. From the standpoint of the working 22 group, we were looking at the therapeutic procedures, the 23 procedures that would fall into your brachytherapy, your 24 teletherapy use, use of remote afterloaders. 25 Then we should also look at oversight alternatives (\ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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l 37 1- for the diagnostic procedures and, from that standpoint, ( 2' look at risk'and come up with a rule that could possibly 3 reduce some of the burden on licensees in the diagnostic 4 area. l 5 Another item that they told us to do was to look
- l 6 at capturing relevant safety. issues and precursor events.
l i 7 For those that were involved in the meetings last year, we ( 8 spent a lot of time talking about precursor events, what was t
'9 meant by a precursor event, and I-will mention a little bit i
10 later -- I think it's tomorrow -- we'll talk about.those, ' 11 .but just to give you an advance warning. 12 We.did hear from the community that maybe it was 13 best to rely on existing regulatory requirements that were 14 in place, those requirements that were in Part 20, for 15 example, Part 30, and not create new requirements for 16 precursor events. So with that in mind, you will see that 17 there is no mention of no requirement for identification of 18 precursor events in the proposed rule that went out. 19 The other thing they told us was we had the option
- 20 of changing the term misadministration to medical event or 21- to come up with some other term for describing a type of 22 event that would fall into.what had been called a 23 misadministration. Hopefully, we're all using the new
~24 terminology, but if I lapse every once in a while and refer 25 to a misadministration, wave your hand or something and say /~g
! / ANN RILEY & ASSOCIATES, LTD. L Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
38 1 "No, Cathy, it's a medical event now." (_,) 2 The term itself is still open. I mean, it can -- 3 we use the term medical event rather than trying to come up 4 with another term. 5 The other thing they had asked us to do was to 6 redesign Part 35 to allow for timely incorporation of new i 7 modalities. This was done -- the best example that I can ' i 8 give you is when the use of remote afterloaders came into 9 play several years ago, what we started doing was really 10 regulating more by exemption rather than being able to go 11 through a regulation. 12- Teletherapy was the closest thing that we could 13 find and we started writing licenses with use this
,_q 14 particular regulation, do A and B, but don't do C, because !
I I
\/ 15 it doesn't apply to HDR, and it made for messy licenses. It .
16 made it difficult on the community, but that was the best 17 regulatory framework we had in place at that time to deal 18 with the issue. l 19 So because of that, we set up a section that is 20 unofficially referred to as the emerging technology section, 21 it's 35.1000, by actual regulation, this has other uses that 22 aren't described in any other part of Part 35. 23 The idea here is that when a new technology would 24' come into play or come into being, that the regulatory body 25 would have some experience with regulating it. The users n
)
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1 39 l' would have experience in actually using the material. They 2 would come in and request a license under this 35.1000 1 3 ; category. They would -- the stakeholder licensees would ' provide us some information on radiation safety and we would 4 l l 5 work back and forth with getting this license, the first 6 couple licenses out. ' l 7 As we gained more and more experience, we would 8 work with, again, the professional societies, we would work 9 with our advisory committee on medical uses of isotopes, 10 otherwise referred to as ACMUI, come up with a good set of . 11 regulations, move to propose rule stage. 12 Once we.got a proposed rule, then we would almost 13 stick it into Part 35.as a subpart unto itself.
., 14 The other thing they asked us to do was to revise ./ 'N .dd 15 the QM program to focus on radiation safety. We will spt."l i 16- some time tomorrow talking about what we did with the I 17- quality management program, but we have deleted the l
18 requirement.for the program. There are still some l 19 requirements for written directives and things associated 20' with the patient treatment. 21 The last thing was that we should use available 22 industry guidance and standards, when possible. What we did 23' in this area was we looked at the available industry
- :24 standards. Where there were key things that we felt were 25 necessary to be included in the rule, we did include them in /~'g -Q ANN RILEY & ASSOCIATES, LTD.
Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l; (202) 842-0034 L
40 1 the rule, and we will spend some time this afternoon talking O ( ,/ 2 about'that. 3 Our approach was, first, to identify the 4 cross-cutting issues and these were the issues that went 5 across the board; training and experience, radiation safety 6 committee requirements, notification following a medical 7 event, items such as that that it didn't really matter 8 whether you were in a diagnostic area or a therapeutic area. 9 The other thing we talked about doing was changing 10 the licensing philosophy and the idea here was to 11 significantly reduce the amount of paperwork that came in-to 12 NRC. Right now, when you apply for a new license, what you 13 need'to do is-to submit a lot of procedures to us and we s.- 14 review those procedures under the licensing philosophy A 15 approach that we're proposing right now as you would submit; 16 the' training and experience requirements, whatever needed to
'17 be submitted for that, tell us something about your
, 18 facility, have a commitment from the radiation safety 19 officer, a delegation of authority, and that's all that we
- i. 20 would look at up front.
l l 21 The idea there is more that we're giving the 22 licensees flexibility t6 develop their programs. i
=23 We did develop a guidance document along with 24 rule-making. What was nice was developing the guidance
- 1. 25 document.at the'same time the rule. There was a lot of e
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41 l.. ,,
.1' give-and-take between what went in the guidance document and
- k. 2 what went in the rule.
3 We were very careful or we tried to be very l l- 4 careful tx) not put any requirements in the guidance
'5 documents. I-know people have pointed out since it's gone 6 out, that, you know, " Cathy, I think this is a requirement.
7 'that's in the NUREG. Didn't you need to put this in the l
-8 rule rather'than the NUREG document." That's the sort of 9 input that we're looking for, because we -- as I said, we l 10' tried very hard not to put hidden requirements and get into 11 - a situation where we would be de facto regulating through 12 the NUREG document.
- 13. The last thing that we worked with was to rely on 9-sg 14' other parts of 10 CFR. If there was a requirement in
(' ') 15, another part that would cover something in Part 35, we l l 16 deleted it from Part 35. The best example is what we did
-17 with the requirements for an ALARA program. '
18 The one thing that I am concerned about, though, 19 is that I've had people come up to me and say, my gosh, 20 you've deleted the requirement for an'ALARA program from 21 Part 35;.that means we don't need to have an ALARA program. 22 -That's not the case and hopefully in the Federal Register i 23 Notice, we made that clear that just by the fact that it's
- -24 not in Part 35 doesn't'mean you don't need to do these
- 25 things any longer.
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42 ' 1 I did give you a list of some of the key things D)
-(, 2 that were deleted from Part 35 because we felt that they 3' were covered in Part 20.
~4 We used a werking group and a steering group 5 approach to develop che rule alternatives, and these were l 6- the rule alternatives that were the subject of last year's '
7 ' meetings. i 8 We also -- we haven't mentioned it so far, but i 9 part of.this package is a revision to the medical policy j 10 statement and then also any of the guidance in the actual I i 11 rule text. 12 With developing -- deciding who was going to be on . i 13 the working group, we tried to get representatives'from each 14 one of the offices that played an important role in the 7-6 l 4
\' # - 15 rule-making; primarily, the office of nuclear material 16 safety.and safeguards, where I'm from, but also the office
- 17. of general counsel, office of enforcement. We had some 18 regional representatives also involved with.the development 19' ~ of.the rule and the regulatory guidance. )
l 20' We did have two representatives from the states; 21 one, Dave Walters, who was unable to be here today, but he 22' is at the State of Alabama. Dave is also chaic of the SR-6
~
23 committee, which is the conference on radiation control l l 24 program directors committee, that's involved with developing i 25: the parallel -- I don't want to say parallel, but medical i ( j) f' \ ANN RILEY &-ASSOCIATES, LTD. j l Court Reporters ' 1025 Connecticut Avenue, NW,- Suite 1014 Washington, D.C. 20036 (202) 842-0034 i L , _ _ _ _
r s 43 ! 1 ' rules'for the agreement states. I L2 Then Marsha Howard, who is here today, and is from 1
~
3 Ohio. 'So we'had that involvement on the. working group. 4~ On the steering group, we h'ad Tom Hill from the
- 5 . State of Georgia-was involved. .So we tried to work with the 6 states to try;to come~up with a rule that is something that
'7- we can all work with.
8 Last year, we did hold meetings in Philadelphia, 9L . Chicago'and Los Angeles. The Los Angeles meeting was part" 10 of the all agreement states meeting. We placed a strawman 11: rule on the internet~in January. We received a' lot'of. I 12- ' comments based on:the.strawman, also a lot of comments based
- 13 on the rule alternatives, and we took as many of those into
- -s 14' consideration in developing the proposed rule as possible.
D- 115 The proposed outline, and this is a, quick:overvi'ew E16 on this. Basically, we had multiple subparts. The key
.17 differences between the proposed and the current come about 18 in that we have pulled.all-the record-keeping and the 19 reporting requirements.out of the specific' sections and i 20- moved them into subparts of their own.
' :21 This was~done to parallel what was done in Part
- 35. l Hopefully, this will make'it easier to use for "23' licensees. It's one of the areas we're looking for comraent 2'42 on;fis it better to have all the records and reports in one !
251 subpart or is-it easier to read through a section that says ! g,j . ' ANN.RILEY_& ASSOCIATES, LTD. 4 Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
. Washington, D.C. 20036
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44 1" check your interlock every day and, in that same section,
~( ) 2 there is the record-keeping requirement, if it's needed to i 3 be there.
{ 4 The other change'that we made -- again, some of 5 these=i'tems I bring up because I've gotten a lot of j 6 questions over'them -- is what we did with training and 7 experience requirements. 8 You will note that we still have a subpart J, i 9 which is the current training and experience requirements, ); 10 but included in.each one of the modality-specific sections 11 is a requirement for training and experience for the 12 authorized user. l 13 This.was done because we are proposing a slightly i 14 different approach to dealing with training and experience fg
- ( ,) 15 and that would be that the individual would have to take an
- 16 exam that was approved b'y NRC or an agreement state cn: pass '
17 a board exam that was approved by NRC, again, or an 18 ' agreement state. And we knew once the rule went into 19 effect, it was not something that could automatically -- the 20 ~ day the rule became effective,fwe weren't going to have this 21 group of approved organizations. 22 . So because of that,.we left the old requirements 23 in the rule. Subpart J would stay in effect for two years 24 after the implementation date of the rule, at which point 25' Subpart J would go away and then you'd have the actual j l 7I
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45 1 training requirements that are in the rule. _(x 2 The last thing I'd mention is the proposed 3 implementation schedule. Again, it is a proposed
- 4 implementation schedule, and that would be that the rule 5 would be published six months after the rule was published 6 in the Federal Register, the rule would become effective for
.7 everything but the training and experience requirements.
.8 The' training and experience requirements, you 9 would have up to two years that we would keep the subpart J.
10 At the end of the two-year period, the subpart J 11 requirements would be. removed. 12 So again, we're looking for comments on whether 13 this is an adequate time period to implement this rule. 14 This is a real quick overview of what the working f)/ (, - 15 group and the. steering group did. Do we have time for 16 questions? I'll be happy to answer anything on what the l 17 working ~ group -- their approach. 18 MR. NAG: Just one request. There are many-short I 19 form abbreviations and for people who are not using them, 20 sometimes it is difficult to know. So would you and all the
- 21. other parties, including myself, spell out the whole thing?
22 . MS. HANEY: Sure, okay. 23 MR. CAMERON: That's a good suggestion. I would , I 24 just encourage everybody to, at least for the first. couple ! 25 'of uses, to spell out what the acronyms mean. Obviously, a ['t T ANN RILEY & ASSOCIATES, LTD. I Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 46 1 lot of these issues with the rule we are going to be A)( 2 discussing over the next two days. So let's try to keep the 3_ questions to clarifying questions about the process, the 4 approach, what provisions-are=where, what is meant by them, ' 5 things like that. 6 Tluem we'll take a break and come back for the 7 first substantive discussion. Does anybody have a 8 clarifying question for Cathy on any of this? 9 MR. THOMPSON: We might clarify that the SRM is 10 called a staff requirements memorandum. That's a document 11 that the Commissioners send to the staff to give directions 12 to the staff for what actions they expect to take. We 13 submit papers up to the Commission with options and.those
,, 14 are called Commission papers, and they are abbreviated like \_ I L15 COM SECY is the kind of the way the Office of the Secretary 16 ' tracks those papers.
I 17 -So when we talk about an SRM, that is a Commission i I 18 decision that comes to the staff and they basically are j 19 majority type decisions,-that it takes at least a majority 20- of decisions of the Commission to' issue a specific decision. 21- If.they split or something else like that, we may get an SRM
- 22. that says there is no decision.
I 23' MR. CAMERON:
^
How about using -- this is good
-24 practice to use the name tense. Let's go to Bob Zoon and 25- then we'll go over to Steve.
/
(7'
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47 1 MR. ZOONi Cathy, the first bullet in the SRM item s _(a ) 2 is to focus Part 35 on procedures _that pose the highest 3 risk. As I read the document, it would seem to me that risk 4 equates to dose._ Is that -- my question is, what basis did
- 5 you use to establish high risk versus low risk?
6 MS. HANEY: From the standpoint of the working 7 group, we were not considering risk of the medical procedure 8 at all. So that was out of the picture. We were looking at 9: the'-- I guess you could say that the dose to the patient j 10- and the risk of something going wrong. 11 I guess I should say if something went wrong, 12 would there be significant hazard for the patient, and,
]
13 again, just focusing'in on radiation safety, not from the 14 standpoint that the procedure actually -- something went p.= k,) ' 15 afoul'in the procedure that was outside of the radiation 16 risk. 17- :With'that in mind, we took the use of the imaging 18 and localization of 35.200 and then the 100 uses into a low 19 risk category,Lin our mind, and then the therapeutic uses of 20- .the 35.400 brachytherapy and the 35.600, the use of sources 21 in the -- in~ devices, as far as the high risk.
-22 -
The one that posed a lot of problem for us was the i 23- use of -- in 35.100, the unsealed uses, and a lot of the 1 1 24-- Commission has been coming back into us and saying, you 25 know, maybe we made that grouping a little bit too large and
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48 v 1 that we'll need to go back and refocus in on that. '(m) 2 When 35.300 was originally written, it was written 3' more at a time when only the iodines and the P-32s were 4 being used versus the bone marrow suppression agents. Now 5 that we're covering a much larger group, that maybe we 6 didn't do as -- we went too far in that area. 7 That was pretty much what the working group did. ; 8 We relied on existing information that the agency had 9 through out event databases, through the misadministration, 'l 10 the old misadministration data that we had available to us, 11 through input that we received from different professional ! 12 societies that had been provided to us. 13' MR. CAMERON: Thanks, Cathy. This will be our l 14 next area, but,' Bob, did you get an answer to your question -(~} g_j 15 about-dose?- 16 MR. ZOON: I~ guess one of the comments I might 17 make is, and maybe referring to our group of 18 -endocrinologists over here, you've got a 50-year safety 19 record with this particular modality that is absolutely 20 impeccable. Was there any consideration of not covering 21 this within the regulation because it's not required? ! 22 - MR. CAMERON: Bob, let's hold the answer to that 23 ~ question for the next' session. It's a great question and we 24 will get there on the 10:45 session. i
- 25. Steve,-do you have a clarifier?
I
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49 1 MR. GAVITT: Yes, just a quick clarification. (v) 2 Under process, what is the time-frame now that you currently 3 envision in terms of the process? 4 MS. HANEY: For the rule? 5 MR. GAVITT: For the rule. 6 MS. HANEY: The comment period on the rule right 7 now closes on November 12. For the medical policy 8 statement, it closes on November 13. The person at the 9 Office of the Federal Register, there were two different 10 people that calculated 90 days from the day they received 11 it. One got November 12, one got the 13th, and they said do 12 you want to reissue it in the Federal Register, I said no, 13 just let it go. 14 So you actually have till the 13th. After that, 7-~ q;) 15 the Part 35 working group will start kicking into meeting on
- 16. a' routine basis. Those are public meetings. Any of these 17 working group / steering group meetings have been public 18 meetings and they have been announced on the bulletin board 19 system.
20 W' will be having a meeting-for sure the second 21 . week in Decamber, where we will start putting together all 22 the comments that we heard at these meetings, as well as the 23 written comments that received. 24 We plan for diagnostic or subcommittee meetings of L 25 the ACMUI in the February time-frame. We'll meet first with f"5
! ANN RILEY & ASSOCIATES, LTD. \ '
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50 L1 the diagnostic subcommittee, and that being where we ask the
/
( ): 2 members of the ACMUI that are involved with therapy, to come 3 in and sit down and meet with us, and then the following , 4 week.we will meet with the diagnostic group. ; 5 There will be a full meeting of the ACMUI where we - 6 will be discuss the rule in total with the entire group. 7 The first week of March, we will come back from that 8 scramble very quickly to prepare a final document that we 9 would forward out for office concurrence, where -- and 10 that's a-process where the working group will develop the ; E11 document and then we'll go out to the different groups to 12 say whether they agree with our approach or not, and we
-13 ' start forward -- we will have something to the Commission by 14 -- it's May 28th', 29th or 30th. I can't tell you the exact is ,)f 15' idate, but whatever the last day of May is, that's when it's
'16 'due to the Commission. '
17 .Then I would anticipate the June time-frame we'll t 18 have a briefing with the Commission, at which point then
~19- .we'll be waiting for the Commission direction as far as 20 whether to go forward or not with the final rule.
2 11 MR. CAMERON: Hopefully, if you ask two different 22L Federal Government employees when the last day of May is, 23 you will get the same answer. 24; MS. HANEY: The last working day. 12 5 . MR. CAMERON: Okay. L fx ANN RILEY & ASSOCIATES, LTD. Court Reporters .. 1025' Connecticut Avenue, NW, Suite 1014 L Washington, D.C. 20036 (202) 842-0034 E
51 1 MR. THOMPSON: I was just going to clarify, to ( ) 2 Steve on the scheduling aspect. Although the public comment N 3 period ends on November 13, that doesn't preclude the staff 4 from receiving additional comments and taking them into 5 account. We just basically have to have a process which 6 will establish a date certain. 7 Any comments recall by the 13th we clearly will 8 include and receive and analyze and put in the rule-making
- 9. package. Those that we receive after that, we'll do it to I i
10 the extent that the staff is available and able to be able 11 to do that. ) 12 So I don't anticipate the comments will stop on 13 the 13th from what's going on here, but there is just a ! 14 process that you have to have certain established dates and
) 15 we'll obviously identify back to the Commission the desires 16 or whatever. ;
1 17 If there is a consensus here that that date needs ; 18 to be changed, we can go back up to the Commission earlier 19 cn that. Whether the Commission wants to wait, there was a 20 lot of pressure on the Commission to change Part 35, to a i 21 certain extent. I think if there is a consensus that Part 22 35 is not so bad, it doesn't need to be changed real 23 quickly, and we need more time, I think that's good 24 information that we can get from this type meeting. 25 MR. CAMERON: Thanks for that clarification, Hugh. ['/ ) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
52 1 Again, back to the acronyms, ACMUI is --
~
f) R.; 2 MS. HANEY: Advisory Committee on Medical Uses of 3 Isotopes. 4 MR. CAMERON: Thanks, Cathy. Terry? 5 MR. JOHNSON: Yes. I appreciate the explanation 1 6 of process that NRC goes through and I can see that this is l 7 already rolling, this whole process, and, furthermore, ti 1: i l 8 NRC is following through with their usual methodology, which 9 involves the 90-day period for public comment, regardless of 10 the magnitude of the rule. 11 I think people around the table here are concerned 12 that this rule-making is all together a different thing than 13 most typical rule-makings. 14 Again, I would recommend that the NRC follow 3 u-
) 15 through with their procedures and publish something, but
,16 just not make it a final rule. I also would think that the 17 NRC would serve the license community very well if you would 18 also publish a draft license application review document 19 that would accompany the rule.
20 Some of the authorized users around the table 21 might not realize that all of the prescriptive elements of 22 NRC rules are not necessarily embodied in the regulations 23 themselves, but in the license review document that the 24 reviewers are obligated to follow. 25 And only by reviewing the entire package of ANN RILEY & ASSOCIATES, LTD. (/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
53
'l regulations and the license review document will a licensee l'J'D
\
2. 3
.really see what's proposed for the future of regulation in this' area.
h 'MR. CAMERON: Cathy, I think you have a comment on 5, that. I would just point out that later on this afternoon, 6 ,I think-we're going to get anfopportunity to lay out what 7: all of these-various documents are that Hugh referred to 8 -that'may not be'in the regulations, but may have an impact. , 9 Cathy? 10- MS. HANEY: Terry, the one thing I would add here 11 'is that the NUREG document that you have, the 1556 volume 9, 12 is intended'to be what would be used by license reviewers. 13 So there would be no other documents that would be used by; 14 NRC that the public would not have seen. ( 15' . Currently, I think what you're referencingf is that ) l 16 for some areas of use, we have the regulations, we have some 1 17 regulatory guides, and then NRC would have what we usually refer to as standard review plans, and this may contain some 4
'18 19 extra information what a license reviewer-should look for 20 when they're reviewing an application.
21 We're doing away with the standard review plans so
. 22 that everything that either the licensee or the NRC license 23; . reviewer needs to see-would be in that orange document.
24 MR. CAMERON: Cathy, am I correct in that we will , 25 have a chance to look at the orange document later on this j l
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54 l' 1 afternoon in the context of the inspection and enforcement [3 2 section?
%~)
3 MS. HANEY: Right. 4 MR. CAMERON: All right. Good. 5 MR. JOHNSON: Could I comment on that? 6 Nevertheless, as the rule is about to change with the 7 incorporation of public comments and so forth, the NUREG 8 document would no longer make sense in many respects and, 9 therefore, a more complete picture for the licensees would 10 be beneficial, including another NUREG document along with 11 the new proposed rule-making. 12 MS. HANEY: Okay. 13 MR. CAMERON: Thanks, Terry. Let's go to -- our l 14 office of general counsel has a comment out there, Margie. (,,) v 15 MS. ROTHSCHILD: Yes. This is Margie Rothschild 16 from the NRC office of general counsel. It may have been l l 17 mentioned, but perhaps just in passing, that that NUREG is a 18 draft and it is out for comment and we are seeking comments ; 19 on that, as well as the proposed rule, the proposed policy l 20 statement. 21 And in reference to the comment just made about 22 prescriptive elements, if there are specific instances where 23 it appears that there prescriptive requirements that are not 24 based on the proposed rule, we certainly would appreciate 25 that being pointed out, as well as any other comments that ! [i ANN RILEY & ASSOCIATES, LTD. (-) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034 l'
l 55 ' 1- people might have on.that draft document. v) '/' 2
-3 MR. CAMERON: That 's Marj orie .
more clarifying question from Aubrey, and let's take a Let's have one 4 break, and we'll come back and get into the risk basis for 5 the proposed rule. Aubrey? 6 MR. GODWIN: I don't know if it's going to be a 7 qualifying question, but it's going to be a statement. The
- 8 states will have a problem because the regulatory 9 requirement is not in the rule. If.it's a regulatory 10 requirement, it has to be in the rules. You can put in a 11 guidance document with suggestions, but if an applicant 12 wants to come in with an alternative suggestion, we're 13 obligated to review it and consider it and we'll change the
- 14. aim of the regulation, we'll issue the license.
(h G 15 MR. CAMERON: Thanks for that important 16 ' clarification. And let's put a final point on that.. This 17 afternoon, before going to the break, I just want to point 18 out that Mary has found in the consolidated guidance on 19 material licenses, there is a list of acronyms. 20 Unfortunately, it doesn't explain them, but at any rate, you 21' will know what all the acronyms are. 22 . MS. ROTHSCHILD: Chip, I'd just like to respond to 23 Mr. Godwin's comment. He is entirely correct. We do not 24 intend to have any requirements in the guidance document 25 that are not found in the rule and it was reviewed with the ( I ANN RILEY & ASSOCIATES, LTD. \l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
56 1 purpose of attempting to ensure that that is not the case, j ~ 1 ~2 But'it is a draft. There.may be instances where
.x 3 there could possibly be some items presented as requirements 4 and if-you are aware of such, we'll greatly apprecie.te that 5 being pointed out.
6- MR. CAMERON: Okay. Than):.s , Marj orie . Hugh, you 7 have another comment. 8- MR. THOMPSON: It doesn't remove the concern that 9 Terry had. Once it's in the license, it is a requirement 10' for that particular licensee. It may not be established by 11' role-making, but when the licensee has made a commitment to 12 e particular issue, that becomes a requirement.for that 13 licensee. g 14 I think that's what Terry was concerned, there may (_ ,/ - -15 be interactions that a particular licensee may have to have s 16 to understand and they would make a commitment. So I don't 17 ~ disagree with Terry's comment. It's very helpful to the
.18 range of the license commitment.
19 MR. CAMERON: We will have time to revisit this 1 l 7-i 20 process later this afternoon. Roy? il 21 MR. BROWN: Quickly, I promise. I want to echo ) i 22 what Aubrey says. A guidance document should be guidance,
-23 should be filled with language such as "could," not language 12 4 of "shall" and "should," and'I think this guidance document 25 has a lotJof "shalls" and "shoulds."
,m-
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i
- .' 57 I
~ 1 MR. CAMERON: I think that probably is a nice way l < ; ( ,) 2' to underscore the issue that we're talking about here. N_/. 3 .Let's take,a break, come back at ten minutes to 4 11, and we're going to get started on our discussion of risk l l-5 with Don Cool and Dr; Carol Marcus. 6 [ Recess'.) 7 MR. CAMERON: We're going to get started with our 8= next session and we have some participants who will trickle 9 .back in here and join us. j 10 You heard Cathy mention and I mentioned this 11' morning about the issue of having a risk-informed rule; in 12 other words, more emphasis on higher risk areas and less ; i
.13- emphasis on lower risk areas. !
14 The discussion that we're going to have now 1N. ( ,) 15 focuses on this issue, is the rule risk-informed, is the 1 { 16 guidance risk-informed, do we need more data, and will that 17 data be influential in terms of the rule; how do we gather 16- this risk data,.what are we talking about when we say there 19 should be a risk' analysis for the rule, and how do we take
-20 .into account uncertainty.
'21 So these and other issues will be addressed. And
.22 'so that you have a context for this, Dr. Don Cool from the l
23- NRC is going to give us an overview of how risk was
- 24. ' considered in the development of the proposed rule. Then 25 we're going to So to Carol Marcus,'who has been kind enough 1 i
[/L ANN RILEY & ASSOCIATES, LTD. Court Reporters I 1025 Connecticut' Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
j 58 ,_ 1- to agree to do a short presentation on the medical l-C
%)
-2 community, at least the nuclear medicine community, their 3 viewpoint on this particular issue.
4 We're going to do that so that we can then kick 5- off a discussion on this issue around the table. 6- Don, are you all set? Don, let's go to you. 7 MR. COOL: Thank you, Chip. Usually, when Chip 8 introduces me, he sort of finishes it up by asking me if I'm 9 ready got tee it up. I was all prepared for that little 10- phrase, because I'm not quite sure in this case whether I am 11 teeing it up in the sense that I am about to hit the ball, 12 to take a baseball analogy on behalf of t-ball, or whether, 13 in fact, it has been teed up and I am on the opposite side 14 and the person who is about to hit it to someone like Mark f i) 15 McGuire. 16- But I wanted to provide a couple of perspectives 17 as we start this discussion today, because it is a 18 discussion which has wide-ranging implications, potentially : 1 19 wide-ranging applications, and there is probably a great 20 uniqueness in medical regulation that the Commission looks
-1 21 at which is different from most any other thing which the 22 Nuclear Regulatory Commission faces in its regulatory 23 program.
24 First and foremost, that.is the fact that in this 25 particular arena, we are dealing with a situation where we l' l i l ANN RILEY & ASSOCIATES, LTD. j \_/ Court Reporters , , 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ' (202) 842-0034
59 1 have potentially three very-different sectors of risk which x 2 at;various times we talk about, at various times we (N- ) . 3 consider, at various times we may even mix up a little bit 4 in the process. 5 The traditional ones, for those of us who grew up 6 in the health physics or the radiation protection kind of 7 perspectives, is protection of workers, occupational risks 8 of exposure, protection of members of the public, and we 9 were all very comfortable and happy growing up in that 10 environment because it was very easy for us to apply our 11 previous rules of time and distance shielding; just keep 12 everyone as far away from it, interpose as much material as 13 possible, and reducing the doses to as low as reasonably 14 achievable or lowest technology would allow you to get or ( ,) 15 otherwise, and everyone would be very happy. 16 Unfortunately, if you do that in this particular 17 arena, that means you don't actually do anything, because 18 there is a third category individuals. Carol and I might 19 agree upon something. I would like that to be duly noted on 20 the record. 21 MR. CAMERON: Do you think that we should stop? 22 - MR. COOL: Which is the patient, the individual 23 who is receiving treatment for some particular disease 24 process or to attempt to determine what may be going on, and 25 the only way that the material can actually be used as py . ANN RILEY & ASSOCIATES, LTD.
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l 60 l 1 ' intended is to put the material and the individual together, ' L[G 2- something which health physicists, by their very nature, can E 3 sort ofEquiver and shake about. 1 4 So we have three very different kinds of risks, 5 'which, at-various times, have very crossed purposes, , 6 . depending on whom we are talking about. So that's one 7 factor that I think we need to consider as we go through 8 these processes. 9 The Commission has been looking at, not just in lLO the medical arena, but all of its programs. The concept of 11- risk-informed and performance-based regulation is to bring 12 everyone up to a basic baseline of understanding. The term 13 risk-informed, versus another term that we might use such as 14 risk-based. Q(,j- 15 Similar in tne t.ense that you are taking risk
~
16 information, but then different in the context of how you 17 apply that'information in a risk-based approach, at least as 18- we have developed our particular terminology; to be where 19 you had risk information inLa very detailed, probabilistic, 20 mechanistic! kind of situation, and apply that very 21: mathematically strictly to the kinds of requirements or the 22 number of requirements or the degree of requirements that 23- are present within the regulatory structure. 24 . On the other hand, what the Commission has, in L .25- fact, be looking at is_a risk-informed approach, whereby l-
)
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61 l 1 that information which may be available and which then may () 2 include information which didn't necessarily derive from all 3 of the specific mathematical, quantitative, highly specific 4 sorts of information, can be pulled together and used to 5 inform the process, should relate to the kinds of areas, but ; i 6 may not have the kind of adherence that engineers or others ! 1 7 might have expected to see in terms of a one-for-one linkage 8 as you move up and down the particular chain, i 9 Risk-general, meaning what can happen; how often l 10 or how likely is that thing to happen; and then what are the 11 consequences. When you start to apply those questions, you 12 can ask that question each time you come up to a particular 13 point or particular action, and the answer that you would 14 get in that situation may be very different if I'm talking i \ ( _) 15- about an individual who is occupational, had some training, 16 he's working with the material, dealing with it, versus an 17 individual who has not had that training, who might be 18- regarded as a member of the public under 10 CFR Part 20,.or 19 who might be the patient who is actually supposed to receive 20 some certain amou'nt of material for that procedure. 1 21 The second part of the phrase we've been looking 22 at and which you've heard, performance-based, refers to the 23 process by which you would put together a regulatory type of 24 program and there are two possibilities there, and you can 25 put these in broad bins or boxes, the first being something s'
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62 I which has been mentioned here and others might be more used ; 9r ( -[ 2 to thinking about, a prescriptive approach, you shall do A; 3 if you do A, everyone is happy and everyone knows exactly . i-4 what A is and A can be spelled out to a decimal place. i 5 'As opposed to an approach where you specify the 6 kind of outcome, the kind of specific results you wish to 7 achieve, and you~ leave to he individual, as we're 8 implementing the action, exactly how they're going to go ! 9 about accomplishing that, and recognize that there may be 10 more than one means to accomplishing a particular end point, ; 11 moving toward an approach where if you achieve the end point 12 that is desired, that is what is important, as opposed to 13 whether you did A, B, C,.D, in that specified order, in 14 ~specified periods of time.
'm {
' (_,I ~15 'There are a lot of advantages in terms of'looking i
16 at points. There are, as you might also expect, some , 17 potential difficulties that have to be dealt with, because i 18 when you start to-look at and think about, well, is-everyone ! 19 . comfortable with this process, if there are a number of , 20 steps or some alternatives, everybody starts to ask, well, 21 am I going to get there and how are people going to look at l 22 it if I had A, C, B, E, D, and is that acceptable or ! 23' unacceptable.
.24 So it raises a number of issues of how you see the 25' particular process and how you write those kinds of '
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63
'l requirements. -[~/ j 2 Now, there have been some issues raised about the 3 kinds of information, the kind of work that has or has not
- 4. been done. Certainly, there is a lot of information that ,
t 5 has been out there, has been available in the context of ! 6~ risk-informed and trying to take some insights from the 7 information that were available, that has been done. Not to l 8 'the rigor that I'm sure -- I know a number of others perhaps 9 would argue to perhaps have pursued, but there are daca on 10 =what used to-be called misadministrations and events from 11 various regimes and time-frames where reporting requirements 12 have changed over time. 13 There was some data back a number of years ago 14 when the requirements were-actually much tighter for what O ( j/ / 15 -you needed to put and a lot more information. That, in 16 fact, suggested to us that there was a lot of stuff coming l 17 in that we probably really didn't need to hear about. There 18 wasn't a great ~ deal of risk, mostly represented in terms of 19 dose that was coming out from that. 20 Those requirements were changed. Those aren't l 21 even reported to us and haven't been reported to us for a
'22- number of years. There is information associated with the 23 ' kinds of actions that have been taken in inspections and 24 enforcement,-the kinds of things that have been found when 25 'you go in and look at events have been reported or has come
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64 l l' to light, which tell us a number of things about whether () 2 'some of the requirements that exist in the present set of l 3 regulations appear to have had a strong correlation with the i 4' kinds of issues that have arisen in practice. ' t 5 That.resulted in the staff thinking about and, in I 6 fact, the Commission likewise, and, in fact, then directing 7 it, to go back and relook at some of the requirements that , 8 exist in the present Part 35, for things like quality 9 management, because there were a number of things in there, j 10 which, when we went and looked back at the relationship 11 between what was in the rule and what was actually - i 12 transparent, what we found was that there were several i 13 particular items; did you have the right kind of person, did i 14 you'get what was intended translated properly and delivered ' 15 properly, for which everything that happened came back to 16 and some'of the other issues and requirements that were in-17 there didn't have a very large result. 18 You will find that those have been deleted from 19 this proposal. So we have attempted to use that information 20 and move in that particular direction. l 21 I want to go ahead and address, briefly, part of 22 this, the question that Bob Zoon had placed on the table. 23 The Commission, in looking at this issue, and the staff, as 24 it has considered it and provided recommendations, has 25 looked at this principally within the context of risk y T ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C.'20036 (202) 842-0034 I l I
65 1 translating to a dose or a quantity of materials type of [v ') 2 requirement; what are the things that can go wrong for this 3 material; if, for that kind of material and-that set, what 4 is the likelihood that this would happen; how accessible is 5 it, how many times has this sort of thing transpired, is it 6 in a device which is on the other side of the shielded wall 7 so that for the worker, the nominal dose in the normal 8 situation is essentially zero, versus are you working with 9 unsealed materials and handling them in order to be able to 10 administer them, which means you're around it a lot more, 11 for which the actual occupational dose is actually greater. 12 You're actually accumulating more dose on a 13 routine basis simply because you're having to handle 14 materials, rather than, as has been suggested or I think may r8
!s ,) 15 -have P0an implied, an operational history. That, in part, 16 and certa:nly ;au "n. argue and put forth other propositions 17 because the c:P ;izal is still present, uses are still being 18 conducted,'and, therefore, the possibility of what can i
19 happen and the consequences and the number of times it's l 20 happening are still present and, therefore, pose some 21 potential for consequences. 22 . The other thing that I wanted to address, just to 23 give everyone a baseline understanding before we begin the 24 discussion, several points this morning. There was 25 reference made to some work which is being done separate
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66 l 1 from this rule-making with regard to potential risks of l
;;e ! -\ 2 various kinds of byproduct materials.
3 There is an effort underway within my group, and 4 it is being supported by a contractor, Scientech, to examine 5 various' risks in terms of occupational dose under normal and 6 off-normal conditions, potential public doses in potential 3 1 7 normal and off-normal, or potential accident conditions, l 8- releases of material or material getting outside of the
.9 normal bounds of regulatory control, such as sources being 10 abandoned, lost or stolen, entering the recycling stream, or 11 otherwise.
I 12 That effort'had a relatively broad mandate and I 13 sent them off to look at all of the various kinds of uses 14 currently authorized under the c .nmission's requirements for 7._ ,
\ 15T byproduct materials; that is, all of the 10 CFR parts in the li6 30 series, everything from radiography in irradiators, to 17, 'small' gauges, to exempt sources.
18 Its purpose was to try and provide some framework I' { 19 within which the staff and the Commission would be able to I 20 examine those various systems to see whether or not the l ) l l 21 existing framework, whether or not specific or general i L~ 22 license or registration or other forms might be subject to l l l l23 change and whether that was satisfactory. That work is 24 ongoing. ! 25 The staff has an obligation to provide the 9 1 e . L( , ANN RILEY & ASSOCIATES, LTD. , Court Reporters ' t 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 ' (202). 842-0034
67 1 technical background and its suggestions and recommendations () 2
.3 for further actions to the Commission by the end of the year.
4 So in that sense, the mandate and mission of that 5 report, while certainly medical constitutes a number of 6 systems, it's not necessarily had the kind of focus or 7 specificity which may get to some of the things that perhaps 8 some folks thought it was going to be. It has a combination 9 of quantitative analyses. 10 There have been some surveys done which have much 11 more qualitative aspects. It has illustrated, amongst other 12 things, that there are widely divergent views, even among 13 professionals, even among similar organizations, with 14 regards to the risks, again, doses posed by various kinds of
,eg
(_,) 15 systems and material, and the kinds of barriers or 16 safeguards or materials that are present that would prevent 17 exposure. 18 The primary function is to t.ry and identify what 19 is the material, what are the barrier systems, procedures or 20 activities which are present, and what does that suggest 21 about the regulatory regime. 22 - With those particular points covered, I will 23 conclude these remarks in terms of trying to give you an 24 overview of some of the things that the Commission has been 25 considering and turn it to Carol Marcus, who is going to be l , ; ) ANN RILEY & ASSOCIATES, LTD. A/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 l (202) 842-0034 i
68 1- providing us with some additional interesting and perhaps 2 divergent comments, - w/ ('~} 3 MR. CAMERON: We're going to go to Carol and then 4 we're going to get into a discussion of these issues. 5 Thanks for that overview, Don. Carol, do you want to use 6 this talking stick? . l 7 MS. MARCUS: Sure. 8 MR. CAMERON: All right. l 9 MS. MARCUS: My voice is about out. First, let me 10 thank Chip for inviting me here today to make a few comments 11 on risk analysis. I think risk analysis is one of the 12 critical issues of this new rule-making and it's good to set 13 some of the groundrules. l 14 I also want to thank Commissioner McGaffigan for 1
, \_
) 15 coming. I know you're very busy, sir, but there are some (J
16 issues here that will take Commission policy decision rather 1 17 than staff or management decision, and I'm really very . 18 grateful that you chose to be here today. 19 [ Applause.] 20 MS. MARCUS: We are very concerned about the fact 21 that no risk analyses of the type we are used to seeing were 22 performed for the hundreds of requirements in the proposed 23 Part 35 and the licensing NUREG. When I say what we're used 24 to seeing, we're used to seeing data that we can look at, 25 we're used to seeing physics and logic. (~N ANN RILEY & ASSOCIATES, LTD. ' '(,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.*20036 (202) 842-0034
l 69 1 We keep hearing that it is risk-informed, but we l (v) 2 have not reviewed a single risk analysis itself and we're 3 wondering where the analyses are working. 4 I don't think that your concept of an analysis is 5 the same as ours. So I'm going to talk somewhat about what 6 we believe is required. First, let me just talk about risk 7 analysis. A lot of people at the NRC really aren't used to 8 this concept. This is the risk of doing something versus 9 the risk of not doing it. 10 Some years ago, when President Bush was trying to 11 get a relaxation in regulation, I talked about risk-risk and 12 meeting with reactor people here at NRC. 13 If there is something wrong with a reactor, the 14 risk of not operating it is relatively low. So one doesn't
!q t.. ,) 15 usually even think about it. In medicine, however, the risk q l
16 of not taking care of sick or injured patients can be very, 17 very high. In fact, with the professions of medicine and 18 pharmacy, we basically exist in a world of relative risk. l 19 A sick or injured patient let alone will have some 20 probability of morbidity or mortality and one hopes that by 21 our intercession, we improve the odds, and I don't want to 22 get into discussions about when that doesn't happen, but 23 generally speaking, I think most people believe that 24 medicine and pharmacy have a place. 25 Even though some of the things we do are very [\' ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i , 70 1 risky, buying'is very risky too. People with fatal diseases j 2 with try things with -- because they deal with risk, because 3- it will, in fact, decrease their ultimate risk of harm. 4 So when we look at the kind of risk analysis that 5 makes sense in medicine, we look at risk-risk and we look at l 6 relative risk. i 7 I was very disturbed by something that was in the 8 Federal Register, that I'm going to ask the Commissioners to l 9 review with the office of general counsel, because I really 10 think-maybe you don't want to say this. '
- 11 It says the Commission rejects regulation of the 12 medical use of byproduct material on the basis of comparable L 13 risk, as the ACMUI and the ADS have proposed. The i
14 Commission' doubts that such an approach would meet the ies l l (%_/ 3 15 statutory standard in Section 161(b) of the Atomic Energy 11 6 Act, to regulate all uses of byproduct material, to protect l ] l 17 health and minimize danger-to life. 18 Now, this appears to be a denial of the use of 19 relative risk or at least risk in favor of absolute risk. 1 1 20 As Don said, the only way to stop all risk in nuclear
.21 medicine is to stop the practice of nuclear medicine. l . 22 .
If'the law is truly this binding, then I think the 23 Commissioners have to think about whether they belong in a
.24 medical arena or not, because if you all play in the 25 relative risk arena, because your law does not let you do l.
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71 ! 1- so, then you can kill people if you want to apply only 2 absolute risk. 3 However, maybe a review either with some different 4 lawyers or just maybe.a little more discussion would be in 5 order. I don't see anyplace in the Act where it says you're 6 not allowed to use relative risk and protecting health and 7 minimizing danger to life can be rather broadly interpreted 8 to include things that have nothing to do with radiation, 9 -and I would really suggest that you rethink this policy. 10 Now, actually, this analysis is the simplest of 11 all. Once you set a risk that you will accept, you simply 12 look at the risk of an activity and just look at its risk 13 and if it meets your standard, fine. It's simple and you 14 have obvious examples of that. I./~T k-s 15 Radiation dose limits for workers and members of L16 the public, for example, we don't have to do a risk analysis i 17 if a procedure will give a member of the public one millirem _ 18 because we're allowed 100, and that's your star.dard. '! 1 19 So in a sense, a partial risk analysis has been 20' done in setting the standards for Part 20 and what we do is 21 size up our activity against that standard. 22 . In most patient-specific things, absolute risk ; 23 doesn't fly. But to some extent, in our practices, it 24 certainly does work well and I give the example of l 25 radioactive waste disposal by a sanitary sewer, using i I-
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72 1 standards in Part 20. I mean, this is an absolute risk 7.,- ( ,) 2 thing and it's perfectly viable and no problem. 3- Now, regulatory risk itself is an interesting 4 topic that most regulators don't think about very much, but 5 it's a very important part of risk analysis. This is the 6 risk inherent in the regulations. And one of the most 7 interesting aspects has to do with the fact that compliance 8 with regulation costs money and when you spend money to 9 avoid one risk, you do not have money available to protect 10 yourself from another. 11 And professional risk analysts have put a number 12 on compliance costs and a risk assigned to it and if you 13 look at several estimates, generally you get one random 14 death per nine to 12 million dollars spent on regulatory
'() 15 compliance.
16 This happens because a road didn't get fixed and 17 there was a pothole and it rained out and money was spent on 18 something else and there was an auto accident and someone 19 got killed. These are random deaths. You can never pick 20 out the one that died because of your regulatory costs, but 21 these are the tradeoffs that occur. 22 - It's interesting then to ask how much is this 22 proposed Part 35 cost. We have a partial preliminary cost I 24 - analysis of the proposed Part 35 only for NRC licensees, not 25 for agreement states, with many aspects omitted and not for
;m
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73 ,
,n 1 the licensing NUREG at all, and that's $100 million a year.
()- 2 All together we estimate, if you assume all the . 3' agreement states do it and we take everything into account, 4' you're dealing with at least half a billion to a billion f 5 dollars the first year and hundreds of millions of dollars a 6 year afterwards.
-7 Now, that's a lot of money. The people from HCFA 8 -who are here, you have determined that you do not wish to 9 reimburse regulatory costs of this nature. Then it's this 1 10 much money. We have a real problem. ,
11 If you make it that expensive to do nuclear j 12 medicine, nuclear medicine, in many contexts, simply will i 13 not be dona and the risk to the patient of not having a rw 14 diagnostic or therapeutic procedure may be considerable. k%s 15 So one of the things that we have to look at is 16 the cost the first year anyway. We're talking about maybe- l 17 80 to 100 random deaths in this country, which isn't in i 18 itself a problem if you're going to save 10,000 people. The ' 19 problem is it's hard to see where NRC saves anybody, because
'20 .you're not letting anyone use radioactive material for 21 medical use. You're letting qualified physicians and 22 pharmacists use it.
23 I don't see that you save anyone and the NAS IOM i 24 didn't think so either.
- j. 25 .There are other regulatory risks involved and that 4
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74 1 includes morbidity and mortality if patients are deprived or [L 2 appropriate procedures, because it's inappropriately 3 restrictive licensing. 4 Now, these are a little vague, in fact, they are 5 lot vague in the proposed rules and the licensing guidance. 6 We were here ten years ago because of the restrictions in 7 use of drugs, the choice of drugs, the choice of how to make i 8 drugs, the diseases to which drugs could be used. l 9 After much blood on the floor, we got a thing
)
10 called the radiopharmaceutical, which is still here, except 11 it appears in the licensing guidance that it is going to be 12 removed and that in many cases or for many licenses, we'll 13 be back where we were in 1987. 14 If that's the case, Hugh will remember several
/"N
() 15 stories of patients who nearly died and we had to go around 16 the regulations because nobody is going to kill a patient. 17 I don't want to go back to that. I would hope 18 that that risk is going to be wiped out by the end of this 19 meeting, if not before. 20 One other regulatory risk that is not here is the 21 risk inherent in dual regulation, which I mentioned at the 22 beginning of the meeting. 23 A regulatory standard may be a very valuable 24 thing, but if more than one agency regulates the same thing, 25 the primary agency gets the credit for it and the secondary l [A/ ') ANN RILEY & ASSOCIATES, LTD. , Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 75 l 1 agency essentially contributes hazard because it contributes
-( ) j!; compliance costs which always has a cost in random deaths, 3 and it's not necessary because someone else is doing it.
4 A huge amount of the proposed Part 35 has
~5 professional standards which are used by the state j 6 regulators of medicine and pharmacy and, to some extent, i 7- FDA, JCAHO, medical quality assurance groups, and we don't 8 need them put into a dual regulatory construct by the NRC.
i 9 So in a risk analysis, you have to look carefully l 10 to make sure that you are not dual-regulating somebody else. 11 Let me show you how you do some of these risk l 12: analyses. We've been talking about them generally. In l l 13: fact, they're not very hard to do at all and I've got three i 14 of them here. l 15 You have a proposed rule that says that only one 16 radionuclide therapy patient can be in a room, it's-a , l 17 private room and bath, and then you asked for comments on 18 that. L l l 19 If you do the physics, you don't need to ask for ! 20 comments and you don't need to have this rule. The model I 21 chose was two thyroid cancer therapy patients. There is a i t I 22 part for 48 hours with one percent uptake in the thyroid i 23 remnant and 200 millicuries given to each patient. I ! 24 assumed an excretion half-time of the non-thyroidal 25 component of 12 hours.
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1 l
76 1 I used ICRP-53 for my dosimetry and'a paper l , (O,) 2 recently published in Health Physics that converts 3 unshielded point source specific gamma' ray constants to the ! 4 shielded lined sources. 5 The dose.from one patient to another from 6 radiation turned.out to be 87 millirem. The dose to a 7 l patient from himself turned out to be 384,800 millirem. ; 8- Obviously, the proportional contribution of radiation dose 9 to one patient from the other in only two 100th of one l 10- percent, it's insignificant. ' i 11- The lower number of 87 means, to me, that if my ( 12 hospital gets absolutely full and there is not a single j i
- 13. extra bed in the place and there are patients waiting in the L 14: hallway in the emergency room for a bed, I'd put a j ii,.h l \_/ 15 non-radiation' patient in the room, because the risk of not 1 16 taking care of a sick or injured patient is much worse than i
17 an 87 millirem risk, when the regulatory' limit is 500. I 18 And this is the kind of risk analysis I think NRC' t .. i l 19 should be doing on its requirements. This one took me five- 1 20 minutes. 21 Here is another risk analysis example for the I L 22 standard of 200/dpm per 100 centimeters squared for maximum 23 I-125 removable contamination. l-l 24 The model I chose was a situation where the 25 maximum allowable'is on the package, that 50 percent of what !
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L4 l-77 1 was on the package was transferred to a worker's hands, that ; 2 _50 percent of what was on his hands was transferred'to the I .VI\ t i l 3 lips, and everything on the lips was swallowed and that 4 there i~s a'high normal uptake to the thyroid gland. 5 j There is the reference for the calculations. The : L 6 dose to the thyroid is two 1000th of a millirad, the l 7 effective dose equivalent .000058 millirem ede. ; 1 8 If you look at current radiation detectors that ; l 9 nuclear medicine people have in their labs, a thyroid uptake i 10 probe,.which is also used as a bioassay probe, has about a ' 11 one percent efficiency for I-125 and 35 counts a minute 12 background at'the I-125 peak, which means that you would be ' 13 counting .2 counts a minute for the 35 count a minute
-14 background and I don't think it takes much knowledge about
() 15- radiation to know you can't do that with any accuracy. ;
.16 Even if you use a liquid centigray counter and i 17 most nuclear medicine departments don't have that, but even 18 if you did, you're still in trouble. It's got a higher 19 efficiency, but a 30 count a minute background is typical.
2
.0 The bottom line here is that the standard is 21 scientifically absurd and is unattainable with present 22 radiation detection instrumentation.
23 This analysis took me 13 minutes. I don't see why 24 it's so hard to do. It basically makes you sit back and say 25 where did this number come from and why do we have any such l ANN RILEY & ASSOCIATES, LTD. ( ' Court Reporters i l ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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78 1 number. ( v 2 We do.have worker dose limits, public dose limits, 3 and now we should simply use the performance standard 4 approach; don't go and tell me how many counts I'm allowed 5 on a packing. Just tell me I better not go over the 6 standard in Part 20. 7 You have to do a number for every single isotope 8 and every single compound that isotope could be on to get I 9 anything that made any. sense. It's a lot of work. But this ! 10 is an example of where a risk analysis should have been 11 done. 12 The next one does not use math. It uses logic. l 13 It's an example where NRC is requiring labeling and 14 shielding of syringes. The requirement says these
.(-
(j 15 requirements -- this is statements of consideration. These 16 requirements were needed because the Commission does not 17- believe that the labeling and shielding requirements in Part 18 20-are sufficient to ensure that syringes, syringe shields 19 or vial-shields are properly labeled to identify radioactive 20 contents. 21 That's a heck of a statement. I'd like to see 22 NRC's database to support it. It just appears intuitively 23 false to me. Professional medical and pharmacy standards l' 24 have always covered labeling and shielding and will continue l 25. to do so if NRC's requirement disappeared. They were there [ ANN RILEY & ASSOCIATES, LTD. I YA /} Court Reporters j 1025. Connecticut Avenue, NW, Suite 1014 ' l Washington, D.C. 20036
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79 1 before there was an NRC. (q) 2 Labeling is a standard in all of medicine and all 3 of pharmacy, not just nuclear medicine and nuclear pharmacy. 4 And then it says in addition, the Commission believes that 5 labeling helps to reduce administration errors. 6 I don't think that's true and I'd like to see the 7 Commission's database to support this. I.have reviewed 8 every NRC misadministration since 1985 and a bunch from 9 agreement states. We are unaware of practices in which I 10 non-labeling is the standard of performance. So where would
.11 such data come from?
12 There are erroneous labels, there are switched I 13 labels, and there are unread labels, and they lead to human j 14 error. NRC's rule cannot address human error. Human error O k_) 15 will occur regardless of rules. 16 So I think that these arguments lose the logic 17 requirement and perhaps the NRC needs to interact more with 18 the regulated' community about what standards of practice 19 are. It's interesting that the steering group and the 20 working group. don't have any representatives of ACR, ASTRO, 21 .ACNO. I know we have Barry Siegel as a consultant, but 22 maybe a little more on the medical side would have helped, 23 so that mistakes like this are not there. 24 Okay. The last slide kind of summarizes the risk 25 problems. First of all, there is so much dual regulation in . . -) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 80 1 l' this Part 35, all of which has no value, that it contributes I
< s) 2 simply net hazard because of the compliance costs. 1 (O .
3 The second is the obvious desire to obliterate !
)
4 human error by regulation and a license condition. The goal !
.5 is unattainable. Human error is independent of regulation 6 and license conditions. It may be decreased by restricting 7 privileges to well qualified professionals, but human error 8 will never be ended as long as there are humans.
9 What surprisee me is that there is, in fact, a l
-10 degradation of requirements for qualification in the works, 1
11 which, if anything, would probably cause an increase in i 12 human error and one wonders why in the world NRC is going in 13 that direction. 14 As a point here, NRC did an analysis of the QM l i
) 15 rule and, not surprisingly, showed that it had no effec't on l
16 human error. Why isn't it out of this rule? Every 17 . professional group told the NRC to get rid of it in its 18 entirety. j 1 19 Certainly identification of patients is a standard l
~
20 of practice, yet it is still there. And I think that the 21 Commission really needs to reconsider the merits of the e' 22- medical program in light of the risks due to its existence. i 23 The costs are enormous and they really take into 24 account two things that shouldn't even be part of l 25' regulation. l'
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! i 81 1 Thank you. IL/ \ 2 MR. CAMERON: ' \_,/ Thank you very much, Carol. I'm 3 going to ask your forbearance during the discussion on this g 4 to have your colleagues do most of the discussion. I would 5~ also suggest that there are a couple of points that we could l- 6: defer until later discussions, very impor' tant points. l _7 One is the whole aspect of the existence of t 8 professional standards, other agency regulation that may
-9 obviate the need for NRC regulation. We do have a session 10 this afternoon on that. I would note that I put up here a
-11: point about the radiopharmaceutical rule being diluted or 12 worse perhaps because of the licensing guidance. I think L
13 that we will need to' address that somehow later on in the 14 workshop. oew () 15 What I would like to do now is go to those of you 16 around the table and then ultimately on to the audience for 17 comment on the. general issue of risk-informed. A couple of 18 points here. 19 One, are there things in the proposed rule or the
~20 guidance that are not-risk-informed and to Carol's points
.21- about what should be included in a risk analysis for this 22 rule,_how should it be done. Carol gave a couple of risk 23 analysis examples that showed one way of how that might be 24 done.
25 I'm looking also for people who might have L t ANN RILEY & ASSOCIATES, LTD. x_A Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l
82 1 contrary comments to what either Don or Carol offered on (J) . 2 this. Let's get go to Roy Brown first. Roy? 3 MR. BROWN: Thanks, Chip. Let me start off by 4 addressing a couple of Don's comments. Going back to the S whole idea of risk-informed performance-based standards, 6 I've got to think back to the DSIs, DSI-12 and DSI-7, a 7 couple of years ago, that talked about a risk-informed 8 performance base and also looking at the SRM. The SRM 9 clearly stated the Commission's intent was to develop a rule 10 that is risk-informed. 11 The frustrating part is that we don't see a risk 12 assessment that has been done. The Commission has this 13 radiation risk working group that I guess their work product 14 is not out yet. Logic says that really to do a fg () , 15 risk-informed rule, you will need to do the risk assessment 16 first and then use that in a risk-informed way to write the 17 rule, where it seems a little backwards this way. It seems 18 like the rule has come out first and we're still waiting for 19 some of the risk documents to come out. So that part is a 20 little frustrating. 21 What I would like to suggest is that we wait till 22 al1 the risk documents come out. The Scientech study, as 23 we've talked about in Kansas City and San Francisco, the 24 industry doesn't think much of that effort and it doesn't 25 think it will contribute much to the risk assessment portion l
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83 1 of this. But if we can at least wait for the radiation risk () 2 3 working group of NRC, their work product to come out, and then share that with the regulated community and then from 1 4 that go back and rewrite the rule or take another look at 5 the rule, I think this is really done -- has been done in 6 the reverse order. 7 Also,'I think once a decent risk assessment is 8- done, as Carol's examples will point out, I think what we'll 9 find is that there will be some justification for 10 deregulation of some of these low risk activities and I 11 think' Carol's examples were great examples, because they 12 were very simple, could be done in a short period of time, 13 and they really point'out the low risk of some of these 14 procedures.
.() 15 MR. CAMERON: Thanks,.Roy. Before we go to Terry, 16 Don, do you want to comment at all on Roy's first point 17 about the cart before the horse and whether -- to what 18 extent the Scientech study is the horse that we're talking 19 about here?
20 MR. COOL: I guess I will. 21 MR. CAMERON: I'm sorry. I promised not to do 22 that, but I did. 23 ~ MR. COOL: I think there are different views. We 24 hold a somewhat different view than you do with regard to 25 whether or not some of the things that we're doing try and O k_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, ini, Suite 1014 ' Washington, D.C. 20036 (202) 842-0034
84 1 look at the overall risk of the variety of byproduct (_y) 2 material is, in fact, a horse which should be specifically 3 pulling the Part 35 requirement. There may be some insights 4 gained. It certainly wasn't set up with any intentions of 5 being a specific fiber to this rule-making. 6 Secondly, while there have not been reams and 7 reams of specific calculations, as Dr. Marcus says, and made 8 examples out of to support this rule-making, I think that we 9 would suggest to you that a specific mathematical 10 line-by-line analysis is not the only way of creating a rule 11 which is risk-informed and which bears relationship to the 12 risk posed by the various types of modalities. 13 That, in fact, when the Commission directed the
- 14 staff to consider and try and develop a more risk-informed e
\m 'i 15 performance-based rule-making, that their direction was, in 16 fact, to us to consider the broader context, the 17 relationship between the modality, the relationship of the 18 number and types and specificity in terms of 19 prescriptiveness versus performance relationship for the 20 various types of modalities. 21 And the Commission, having examined the proposal 22 that was provided for it, was sufficiently comfortable with 23 that approach having met its direction that it determined 24 that it should b= published as-a proposed rule. 25 MR. CAMERON: Okay. Think about that for a while. 4 /G V ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
85 ; 1 Let's go to Terry Johnson and then over to Subir. Terry. () :2 3 MR. JOHNSON: Yes. I have some personal experience in my background that I can amplify Carol's l 4 comments with, strictly from the viewpoint of an. 5 non-physician. 6 My first job as the RSO was at a Veterans' 7 Administration Hospital in North Port, New York, and there I 8 also was the medical physicist. We had a Cobalt machine and 9 treated about 25 patients per day. 10 Dr. Alice Louie was a radiation oncologist and she 11 asked me at one point to start attending tumor board 12 meetings, which baffled me at first, but I did it. And I 13 found out that tumor board meetings were basically a meeting 14 between one or more surgeons, one or more medical () 15 oncologists as chemotherapists, and Dr. Louie, who was the 16 radiation oncologist. 17 And very difficult patients would be presented, 18 usually patients that were dying, and after a discussion of 19 some minutes on each patient case, what often happened was 20 the surgeon would say that he could do nothing. 21 Then often, not always, the medical oncologist 22 wQuld say'he could do nothing. Dr. Louie could offer 23 patient something and could treat the patient. Often just 24 palliation.
.25 But this was -- these were patients that are dying ft Nl ANN RILEY & ASSOCIATES, LTD.
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86 1 and this shows you how important the use of radioactive { '2 materials is in medicine and the importance it is to 3 patients. When Dr. Louie agreed to treat the patient, that L 4 was the only care they could get in light of their grave 5 illness, very often. 6 MR. CAMERON: Thanks, Terry. I think that goes to 7 Carol's first slide, the first point about value of this. 8 Subir? 9 MR. NAG: I feel the risk-informed 10 performance-based obviously is important and one thing we 11 have to recognize is that radiation therapy can be by 12 brachytherapy. And you can get some of the desired effects 13 by brachytherapy. You have a different separate standard 14 when you are a treating a patient by brachytherapy than by { O) I 15 teletherapy. 16 Now, you have the risk, but most radiation 17 oncologist do both teletherapy-and brachytherapy and if you i 18 are over the step there in brachytherapy, people are going l 19 to shy away from brachytherapy and the desired good effects, 20 and there are many primary benefits of brachytherapy, will 21 be lost because people say that's too much of a headache, 22 I!m not going to do it that way, I'm just going to turn the 23- beam on and' treat the patient by teletherapy, and that 24 happens all the time. 25 But I am primarily a brachytherapist and, I l
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87 1 'therefore, I would do brachytherapy no matter how
~( )' 2 restrictive the regulations are, but obviously I'm not going 3 to see it that way.
4 And therefore, I am just going to give you a 5 couple of examples to highlight this and this will be Dr. d 6 Marcus' exhibit in nuclear medicine and I will show you how 7 different brachytherapy and teletherapy can be. 8 .For example, if in teletherapy you want to treat a
)
I 9 given organ, prostrate, you say I am going to treat the 10 prostate by 6000 centigray and you take the field and you ! 11 made'the beam, a six by six field or you may give a ten by $ 12 ten field and 6000 and let's say you wanted to give a six by 5 13 six field and times eight or otherwise, you do an eight by 1
. 14 eight. That's fine, that's not a problem.
O (_ l '15 'Jow , in brachytherapy,.the dose and volume are 16 interrelated. For example, if you gave 100 millicurie to a 17 certain organ, you get 10000 centigray. If you gave double 18 the dose or double the number of millicuries to the 200 19 millicurie, you definitely have a medical event or 20 misadministration, but actually what you had done is treated
- 21. a-little bigger volume.
22 . So you put that into the six by six. I still get 23 10,000, but you are seven by seven. So now you have created 24 .a misadministration because you treated a bigger volume. 25 So I think before we -- the NRC has to make (~N ( ); ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 88 1 regulation and that's why they had to make certain " 2 regulation and you are asked to say within a certain percent
~
L3 what they are calling a misadministration. '
)
4 So any definition you gave, for example, 30 1 l 5 percent, is really arbitrary and this has to be taken into ' i 6 account. l l 7 The othe. thing, for example, what do you mean by I 8 the wrong site? Again,.with teletherapy -- and, again, you { 9 have to combine the two, because these are two methods of
~
10- it, you treat the prostrate, but we all know that the 11 patient moves, we'all know that the field may move and you-12 -move by two or three centimeters and that is our normal QA 13 -process. The field moved by one centimeter, but that is
- 14. -fine. But in the brachytherapy, that can become a
() 15 misadministration if the associate moved by a certain amount 16 from the intended area. 17 Similarly, I would say in the use of gamma knife 118- versus steriotactic radiosurgery, you can do similar 19- ~ treatment, not exactly the same, but real similar with a 20l gamma knife using Cobalt therapy and using external beams, 21 and then rank similar magnitude of difference. I'm not even
.22' going to call it error, but similar differences happen,'then 23 it's not a-misadministration or a mistake. But that does 24 trigger a medical event in brachytherapy.
~ 25- And:the other one is a permanent implant. Again, ANN RILEY & ASSOCIATES, LTD. O's3 /' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 h
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l 89 1 in a permanent implant, we have to arbitrarily, again, put a l() i \s,/- 2 certain number of millicurie or a dose that we want to give 3 to a certain site. However, this is dependent on our l 4 i assessment in the operating room at the time of surgery. So l 5 you are forcing us to prescribe a certain dose and we don't
~6 know what we are going to give because the dose is going to 7 depend on and the number of millicurie I want to give will 8- depend on the volume I'm going to assess at the surgery.
9 but because you have asked us that it has to be done, , 10 otherwise you have done a misadministration because you are l 11- giving a radiation material, we write an arbitrary amount 12 and then we have to revise the amount because that amount is 13 going to change. ' t 14 So these are some things that I think'you cannot () 15 dictate by regulatory means and what you should_be 16 regulating -- yes, you do have the right to regulate the i 17 . amount of radiation the surrounding personnel have, but 18 absolutely necessary, but I think those are an arbitrary i 19 definition of more than 20 percent, calling that a medical ! 20 event, those should be left to the QA rather than a l 21 reg'latory body. 22 . I think that should be important to highlight the
.23 differences between brachytherapy and teletherapy and also l 24 nuclear medicine. Again, many of the rules that were made i' i
25 in the NRC came from a nuclear medicine legacy. i 1 i
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90 1 Brachytherapy is very different from nuclear medicine in (Gj 2 many ways, including the volume and localized radiation 3 concept. 4 Thank you. 5 MR. CAMERON: Thanks, Subir. I guess you're 6' pointing out some potential inconsistencies in the rules for 7 applications that may have the same type of risk. Thank
-8 you.
-9 Let's cg) to Jim Deye and then we'll come up here 10 to John Whyte.
11 MR. DEYE: I have a number of commes.cs that may or 12 may not be coherent at this point or cohesive, but that come
.13 up relevant to other things that were said this morning.
14 I certainly agree that we need a better exposition C\
-(,) 15 of risk-based analysis. I have not seen that.either, even
~16 'though the terminology is being used a lot around this table 17 and in the documents. I think it would be very helpful to 18 see that that basis before we go further with the 19 discussions.
20 An example of that is that we still have never 21 been able to arrive at a publicly acceptable definition of 22 -below regulatory concern.
- 23 It seems to me that until we can at least agree 24 that there is such a concept as BRC, it's going to be very
'25 ; difficult to.use risk-based studies to do anything 3 ANN RILEY & ASSOCIATES, LTD.
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91 1 significant in regulatory fields. i 2 I also agree with Dr. Nag that people do make {} 3 decisions, very important decisions on the basis of the path 4 of least resistance. Therein lies one of the reasons, not ' 5 the major, but a reason why Cobalt-60 has suffered relative 6 to-Linacs. There is no doubt that many institutions look at 7 the regulatory burden of Cobalt versus Linac and chosen 8 Linac because of the regulatory differences there, and he 9 gave other good examples of that.
),
i
- U3 -I don't think we can ignore that as we sit here 11 and try to draft regulations, th.'.s dichotomy of the 12 regulation of radiation at the national level between NRC, J 13 FDA and other bodies.
14 I think there is also an issue that Dr. Marcus -- () 15 I think it was she who said that it's questionable whether 16 the enabling legislation for NRC should put it in the 17 business or does put it in the business of regulating 18 radiation safety of a patient. There is a very, very, very 19 significant difference, which Terry Johnson alluded to also, 20 between patient prescription and radiation given to other l 21 members.of the public, be it staff or general members of the 22 public. 23 I certainly see that the NRC has a very major role l l I to play in the latter two categories, but I think you have 24 1 l 25 taken on a tremendously difficult situation vis-A-vis all t l i[ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034 I I
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92 1- the medical interests you've got around this table when you l
'(m) 2- get into the use of radiation on patients under a licensed 3 accepted board-certified physician. I think you really have ,
4 opened up a Pandora's box years ago by getting into that 5 field and it continues to exist even today. We need to look 6 at that further. i 7 Lastly, I would say that somehow we need to find a
.8 better working relationship between the medical community 9 and the NRC. I keep hearing hyperbole on both sides of the 10 equation whether it's the NRC getting into the practice of 11- medicine, which I think is a big of hyperbole on the part of l 12 the NRC, an overstatement of their charter possibly, or it's 13 on the medical side of the community, which I am involved 14 with, when I hear statements that regulations of radiation ,'~%
(sl 15 should be thrown out all together. 16 I just can't imagine the hubris it takes to make a 17 statement like that. I have worked in hospitals for 25 18 years and I know that they would certainly be more dangerous 19 places from a radiation safety perspective for a staff 20 certainly. I won't gel into the patient question because I 21 .think that, as I say, is a totally separate issue that needs 22 to be dealt with separately through medical credentialing 23 and medical staff issues. 24 -But from an employee and general public l 25- perspective, I am 100 percent convinced that regulations ANN RILEY & ASSOCIATES, LTD. Court Reporters
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93 1 have had a'significant, positive effect, maybe counter to , 1 l 2 what Dr. Marcus said earlier. I think it has saved lives ! I 3 and detrimental effects to other staff and I see it
\'
l L 4 continuing today even through the fluoroscopy use that's { 1 5 going on in hospitals and so many settings. { i I i 6 If it weren't the FDA's renewed interest in the 7 high. dose outputs of fluero units, I'm not sure that those 8 units would be getting the scrutiny that they're now L 9 starting to get in the hospital setting. l 10 So in that sense, I think we need the oversight 11 that the NRC and FDA give us the underpinnings'for. So ! 12 those were just a few comments. I- 13 MR. CAMERON: Thanks. I take it that it would be l, 14 fairly easy to draw that line between the occupational and
~
15 the patient as you're suggesting. {) , 16 All right. John. 17 MR.'WHYTE: Although I did say in my introduction 18" this morning that I was primarily here as an information
..19 . source, I'do want to make just a few brief. comments. First,
!. 20 -I wanted to thank Dr. Marcus'for what I thought was an l 21 excellent presentation and I couldn't agree more that there l 22 needs to be a better risk-based analysis. L 23 The point that I want to underscore from an agency 24~ that issues a lot of regulation is her point that we often 25 forget'that regulations have a tremendous amount of costs t.
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94 1! and it's often the cost of the regulations that sometimes , .() 2 take away from the resources that we could devote to 3 patients. 4 So I just wanted to. underscore that point, because ) 5 I think sometimes we lose sight of that and forget that i l 6' fresources are limited and that the more money or resources ! 7 that we channel toward regulations that may not have
- 8 demonstrated benefit, the more we may be harming patients.
9 So, again, I thought your presentation was very l 10 informative. 11 MR. CAMERON: Thanks, John. I think that-your 12 point sort ofiunderlines something that Bill Van Decker said 13 this morning about the impact of regulatory compliance costs
-14 on access of patients to care and on things that those
) -15 resources could go into alternatively.
- 16. Bill, do you want to -- is that your point? )
l 17. MR. VAN DECKER: That's certainly my point. 18 MR. CAMERON: Jim Fldtcher. ; 19 MR. FLETCHER: Thanks. 'I've been trying to hold 20 my thought, as there's been a number of cards up here. So
~ 21 - .I'll try and make this reasonably short and clear.
22 . I'm-going to talk about evidence and come at this ! 23 from a slightly different way, talking about evidence, and 24 draw some parallels between what is sort of an emerging 25- trend in health care and medicine today, the practice of ANN RILEY & ASSOCIATES, LTD. - () Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
95 1 medicine, and risk analysis. That sounds like they're 2 [Gl totally unrelated, but I think there are a couple of useful 3 things to do in drawing those parallels and making some 4 analogies. 5 What evidence-based medicine is, and I'm sure many 6 of you have heard the term, is really sort of a new paradigm 7 whereby physicians made decisions about what they will do 8 and when they need to do something on the basis of the 9 evidence that exists. 10 I'm sure all of you sitting around the table, if 11 you're sick, would rather be dealing with a physician who is 12 well informed and has the information that doing practice A 13 as opposed to practice B is going to result in a better 14 health outcome for you. ('3 (, / 15 Are there situations where evidence doesn't exist 16 in medicine? Absolutely. And what do we do at that point? 17 We try and build consensus from experts and depend on 18 filling in the blanks where we don't have all of the 19 evidence to make a well informed decision, and I think 20 that's the first parallel that's important to draw here. 21 Carol Marcus, I think, showed some examples this 22 morning where we have considerable evidence from a health l 23- physics perspective and so on to deal with whether or not we 24 need to do this or do that, to do A or to do B, or to make a 25 decision to take one path or another. s ( ) ANN RILEY & ASSOCIATES, LTD.
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l 96 1 Clearly, as Dr. Cool said, there are other r^s l l f
\m /
1 2 situations where you don't have all the evidence and you've i 3 got to look at something like logic or you've got to develop 4 a group of experts to provide you with their best informed , 5 decision and create a consensus for a decision process as to j 6 whether something needs to be done and whether there is or l 7 is not a problem. 1 8 So I think there are some very interesting 9 parallels between these two and the risk analysis could 10 certainly proceed to take advantage of the areas where we 11 have evidence in terms of dealing with these things and 12 where they're straightforward, and I think there are a lot 13 of instances where that is the case. i' 14 I think also one needs to look at whether there is
,m k ,)
s 15 a problem or not and just to make one final comment, at a 16 meeting that I was in this city several months ago, an AMA ; i 17 meeting, Dr. Berwick referenced an article in the medical 18 literature talking about adverse drug events in hospitalized 19 patients and that was an article that was published in the 20 Journal of the American Medical Association in the middle of i' 21 1997, and that there is a problem. 22 . It's a six or seven percent event rate and the 23 costs to society and to patients and the increases in 24 lengths of stay and really considerable morbidity associated 1 25 with this is really a problem and something needs to be done - 'g* ANN RILEY & ASSOCIATES, LTD.
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97 1 with it. () 2 So there is evidence that there is a problem and 3 that an alteration needs to be made in a system to deal with 4 it. I think we need to say what is the evidence that we 5 have a problem and what are the solutions to deal with that 6 problem. 7 MR. CAMERON: Thanks, Jim. I think that's 8 something for all of us to think about, is putting aside for 9 the moment whether there is sufficient risk data to support 10 the proposed rule, what type of methodology would be used to 11 do a risk assessment as a basis for a rule. 12 Don talked a little bit about a methodology that 13 the staff and the Commission had considered. Jim talked
,m 14 about this evidence-based parallel and, of course, we had k s) m 15 Carol's examples. It may be that there is a number of 16 different methodologies that should come into play depending 17 on the facts involved.
18 But I think that that's one of the things that 19 we're looking for here, is that people say, well, the rule 20 is not risk-informed; well, how do you-make that rule 21 risk-informed. 22 - Let's go to one of our agreement state 23- representatives. Aubrey. I tried to keep the microphone 24 away from you. 25 MR. GODFIN: Just a couple of comments about f'%) i
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98 1 what's been said so far. I would remind everyone that we're 2 not necessarily talking'about institutions, that there are (-)S N 3 facilities that are using therapy in a non-institutional
- 4 basis, although most of it is institutions, and they would 5 not have the advantage of a credentialing program in that 6 case.
7 I would also point out a case where there was a 8 credentialing program, I believe at Riverside Hospital, 9 where there was an improper calibration of a therapy unit. I 10 So credentialing does have some pitfalls with it, too. 11 Secondly, I'm glad to see that the NRC has joined j l 12 Alabama, at least when I was at Alabama, in that you 13 selected some bad instrument numbers. I did that. It's 14 real tough when you get them into regulations, if nobody
,r~sG) 15 points it out before it gets into the' regulation, and you go 16 out and try to do something and you're regulation just 17 absolutely is dumb.
18 Carol did a good job'of pointing that out. You 19 need to look at those carefully. That's the voice of 20 experience. 21 I would also point out that in doing risk analysis 22 and studying the effects of everything, you have to look at L 23 ithe number of patients, the number of people that may be 24 involved. u l: 25 .Some things that may relatively look low risk in
- (~N ANN RILEY & ASSOCIATES, LTD. < (_,)~ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
99 1 an absolute sense, because they do involve a fairly large 2 number of potential patients or public exposure, depending fw,')T 3 on which issue you're looking at at the time, may require 4 more looking at, shall I say, than it would otherwise 5 because of the bare numbers. So do remember you're looking 6~ at numbers as multiplied by the probability and the number 7 of patients or people involved. 8 MR. CAMERON: Thanks a lot, Aubrey. Let's go to 9 Jennifer and then over to Mary, and then we'll go to Paul. 10 Jennifer? 11 MS. BUCHOLTZ: Thank you. Just to reiterate what 12 people are saying, I know the IOM committee really did try 13 to look at risk analysis and the data was not complete out 14 there, and that was one of the biggest problems they're ( ,) 13 coming up with, changing this proposed rule. I 16 I would like to insert that I think one thing that l l 17 Carol left out was the perception of risk and I think peopi-18 have to consider that when you look at, if another risk 19 assessment is going to be done, risk analysis going to be 20 done, because that's what drives the public. 21 I can say from personal experience that's what 22 drives the nurses' fears. It's changing their affective 23 learning that's the problem, not giving them data. You need 24 to understand the data, but it's usually their affective 25 fear about the situation that's the problem. [.,'} ANN RILEY & ASSOCIATES, LTD. x/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
100 if So I-think when you look at risk analysis, you 2 must consider perceived risk as well. 3 MR. CAMERON: That's the first we've heard of that 4 at-this meeting. We've heard the perceived risk issue at 5 previous meetings. Mary? 6 MS. FOX: Whenever.you use a ten curie source of 7 iridium, there is a risk and I think this risk needs to be 8 regulated. I deal with nurses all the time and the general 9 public and they do feel a safeh net knowing that this is 10 regulated. 11' . When I try to emphasize something, that maybe this 12 is. regulated by the government, the-government can come in 13 anytime unannounced and inspect me, there is a security for 14 me and whoever is working with that patient that's receiving 15 that dose, they feel safe. They may not feel safe.with me, 16 but they feel safe with the government that's behind it. 17- Why?. I have no idea. Especially with the state 18 of the government these days. 19 MR. CAMERON: I'm glad you added that last part. 20 MS. FOX: With the state of the government today, 21' you just never know. 22: . I think that the best thing that we can do, the 23 NRC, is trying the base the regs on what we are telling 24 them, so hopefully they'll" extend their comment period and 25 they'll listen to what we have to say and write a reasonable .g ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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-1 regulation.
() 2 I am also from the land of managed care in i 3 Minnesota and I am .very sensitive to costs. We go out and ! 4 buy used accelerators and Ccbalt units and dose calibrators 5 because they cost too much and we're trying to comply with
-6 the regulations, but in the end I do think some of the money 7 -- I'm not sure of the amounts'that were presented today,
.8 -but some of it is money well spent to protect the workers l 6
i L 9 L and the public and the patients. 10- MR. CAMERON: And I guess the psychological aspect ! 11 .that you've brought up is sort of related to the perception, 12 the perceived. risk issue in the sense that Jennifer had
-13 spoken about. i 14 Instead of Paul and -- Jim Marks, you wanted to i 15 make a comment too, we'll get to you. Paul?
16 MR. EARLY: First of all, I want to applaud Carol 17 for her presentation. Secondly, I'd like to throw into this 18 pool of consideration one overview or one thought or ; 19 something. 20 I recently gave a lecture on radiation safety in , 21 the United States at the World Federation of Nuclear 22 Medicine and quite a few countries were in the audience and
.23 I was detained quite a while after my lecture because I
-24 presented many of these proposed regulations.
25 And they're currently in the process of getting l' i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
102 l l 1 control in the European community or union, whatever they i[ i%-) 2 call it now, they keep changing it, and they're looking at 3 us to see what kind of regulations we are going to impose l 4 and if we don't have good risk analysis on these i-j 5 regulations, we are going to be hard-pressed to defend the 6 regulations we are going to impose. 7 MR. CAMERON: Thank you, Paul. Carol, we'll get 8 to you in a minute. Let's go to Jim. 9 MR. MARKS: My question is directed to Don Cool. 10 I'm trying to understand why the NRC has difficulty 11 assessing risk. I'm assuming that is has some difficulty 12 assessing risk. Risk is nothing more than a comparison of 13 the part to the whole. It has as numerator and a 14 denominator, a number of adverse events in the numerator and
/~
( ,T) 15 the total number of events or administrations in the 16 denominator, procedure by procedure. l 17 Certainly, the number of adverse events were 1 18 quoted to you. Do you have a good handle on the total
)
19 number of procedures so that you can estimate risk? I 20 MR. COOL: Actually, you have identified one of 21 the significant issues, not just for the Commission, but, in 22 fact, I think nationally, which is exactly what is the 23 denominator, what is the total number of procedures, and I 24- even to some extent what you call the denominator, because l 25 in some cases of brachytherapy and teletherapy, is the l ANN RILEY & ASSOCIATES, LTD. I\' ') ' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I I 103 1 = denominator the total number of factions, because each one (~'p 2 of those is an opportunity, or is the number of patients, q) 3 which may have four or five factions associated with it. 4 We have over quite a number of years attempted to 5 make estimates of what that denominator is. The Commission, 6 in fact, has had some specific presentations and discussion 7- on what that denominator is, but that does not mean that l 8 there is any what I would say is a high degree of precision l 9 or agreement as to exactly what the denominator is for 10 various pieces of the category. 11 MR. CAMERON: Jim, you have another? 12 MR. MARKS: I'll just carry on with two questions ! 13 and a comment to you, then. If, for instance, you have 14 documented that risk or the number of adverse events in s 15
. (-s) relation to the total number of administrations is low, then
.16 you wouldn't pursue such an extensive revision of the rule, 17 with the possibility that public safety might be adversely 18 affected.
19 Would it not be better to pursue change that is 20 incremental instead of momentous and lessens instead of 21 magnifies the potential risk of using isotopes for 22 diagnostic therapeutic purposes? l. I 23 I'm not sure we have a rational basis for all of 24 the change that has been proposed in this rule. I think you l 25 need to concentrate more on defining the risk procedure by ,'i-
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104 )
- 1 1 procedure and if you lack the denominator, then you need to c.
( 2 come to us out in the medical community and find it, it's \
%)
1 3 available. l L 4- I can tell you the number of patients that have l 5 been irradiated at Missouri Baptist and in what way and you l l l l 6 can document the number of adverse events. l l l 7 I would go on to say that if the regulations are 8 out of date or ineffective in protecting the public, then 9 change them, but if they are effective and not broken, then 10 don't fix it. 11 MR. CAMERON: Thanks Jim. We're going to go to 12 other people here, but I think Jim raised a point that was 13 alluded to earlier by both Carol and Roy Brown, I believe, 14 about input from the medical community, some sort of shared (3 (,/ 15 process to try to develop a risk assessment for this l 16 particular area. 17 Marleen? And if anybody has any further thoughts 18 on that, put them forward. Marleen. 19 MS. MOORE: I'd like to reiterate what Jennifer 20 said about much of what we deal with is not risk, it is a ! 21 perception of risk. What we deal with on a day to day 22 basis, we have patients, public, other physicians, everyone 23 with whom we deal, what administration is doing in 24 supporting the radiation safety program or use of materials 25 in their institution, and that perception of risk is ! . [Nt ANN RILEY & ASSOCIATES, LTD.
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105 l l 1 something that, from what I have observed, is in no way [L.]'i 2 related to what we may define as risk. 3 So I think that you're starting out with a huge 4 difficulty in just trying to come to a consensus on what the 5 definition is going to be that you're basing the regulation 6 on. i 7 I feel that -- and this -- I feel rather like Jim 8 is saying, but I'm not totally formed on what these I 9 statements are, but I'll try to throw them out. 10 I feel that one of the things that the regulations 11 should do, to reiterate what Mary said, is to provide an 12 assurance to a patient that those things that we can do to 13 assure that the study thEt they are receiving provides the 14 most information, done in a very timely way, done -- gs t,
) 15 bringing in new technology, done as thoroughly as possible 16 to be available to the patient and done in a way that is not 17 going to use up a lot of their time because we've made a la mistake is what we should be aiming for.
19 This is something that I don't think has been 20 thrown out yet. I really would like to also just reinforce 21 what Mary said, that the population does -- in my 22 experience, people calling, does like to hear that we are 23 then looked at some way or another. 24 The other point is I think much of what I feel as 25 concern as medical physicists and radiation safety officer, l l [') ANN RILEY & ASSOCIATES, LTD. A~ / Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
106 1 and also what the technologists that I've interacted with at l t -s
- (/')
s_ 2 the State of Vermont feel, it goes to another point that 3 will come up later in our discussion of what is the l 4 enforcement and how will the NRC then be working with us as 5 licensees as implementing some of these, and we'll be moving 1 6 away from a punitive situation, which is what it has become 7 in recent years. 8 MR. CAMERON: Thanks, Marleen. We'll get to that 1 9 latter issue. Let's do Roy and then Carol. ( Roy? 10 MR. BROWN: I just wanted to make a quick comment 11 about the cost issue before we get off it and lose it all 12 together. I'm really glad to see HCFA here today. I think 13 that makes a big difference. We had quite a bit of cost 14 discussions in both Kansas City and San Francisco that we (m) 15 kind of decided to wait till the meeting today when you guys 16 were here. So I'm really glad you guys are here. 17 Mary also commented on it, but what I want to 18 address is the cost of unnecessary regulations and some 8 19 cases where you really don't need a regulation and you 20 impose it on licensees anyway, maybe record-keeping, as an 21 example, and patient release criteria, that drives up the 22 cost of nuclear medicine and what you end up having, you 23 have competing modalities, like echocardiology, for example,
.24 competing with nuclear cardiography, and it becomes very, i 25 very difficult and you face the -- the hospital faces a T
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107 1- decision and.the financial people at the hospital face a [
-(
2 decision where do we go with nuclear cardiology and perhaps 1
- 3. not make any money at all or even lose money or do we go 4 with echocardiography and make money. l 5' So we need to keep that in mind, too. I'm not
{ 6 saying that we should deregulate nuclear medicine just to 7 save money, but there is increasing costs with unnecessary EP regulations and-in HCFA the reimbursement levels keep going 9 down and down and down, which they have their directive and 10 we understand that that's part of your mission. 11 But with DRGS and APCS coming along now, we're 12 looking at some of the APC costs and the nuclear costs now 13 and. compare that to the new regulations that are comir.s on 14 line and we just see trouble for nuclear medicine coming ' O g 15 down the road. 16 So we really need to be careful and make sure all 17 these new requirements really are necessary, so we don't 18 artificially drive up the cost of nuclear. 19 The only other thing I wanted to mention was, Don, i 20 we do have quite a bit of data ou nuclear procedures, the 21 number of. procedures that were done by isotope, by category. 22 There are several companies that are out there collecting 23 that data and we use it in all of our market surveys. 24 So if NRC needs that information, we can make that 25 'available to you. O ANN RILEY & ASSOCIATES, LTD. Court Reporters
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I 108 l 1 MR. CAMERON: I think that before we go to Carol,
/^N (v ) 2 I know that the cost issue is going to come up again, 3
because I think that Bill van Decker wants to talk about it. 4 I guess the question is, how do you factor cost into the 5 risk assessment equation. That's -- we know -- we saw what 6 at least Carol's costs were and I think Cathy has some costs 7 that she could share from the NRC's regulatory analysis. 8 But how do you put that into a risk analysis framework. 9 Carol? 10 MS. MARCUS: I'd like to clarify a few things and 11 make a few comments. First of all, when I say that NRC 12 doesn't save anybody, I meant it doesn't save any patients 13 with Part 35. I believe there has to be a Part 20. I'm not 14 sure I like this Part 20 all that well, but there has to be n ( ,) 15 a Part 20 and certainly standards for workers and members of 16 the public and environment have to be there. 17 I was only referring to Part 35. 18 As far as the comments about the number of 19 procedures, though, NRC paid for an NCRP commentary some 20 years ago during the battle of the QM rule and that included 21 up-to-date information on the numbers of different kinds of 22 nuclear medicine procedures and that data came from 23 industry, which keeps a very good handle on it because the 24 manufacturers have to know how much they're going to sell. 25' So these data certainly are out there. Keep a
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_ . _ . - - _ _ _ . . _ . _ _ - - ~ - - - - --- - - - - l l !" 109 1 number in your head. There have been over 300 million doses i l'
\m-)'
2 ~ of radiopharmaceuticals given to patients for diagnosis and L [' 3 therapy since 1936. There has been one probable radiation 4 death from that, that was human error and no number of l 5 regulations could stop it. 6 That was.that Gold 198 colloid dose that was given 7 in millicuries instead of microcuries. I would say, 8 parenthetically, that every non-radioactive drug that the 9 FDA has ever approved they've given in a thousand times the 10 amount it says on the package labeling would kill a patient,
- 11. too.
12 We are the most safe group of drugs available in 13 the United States. We are safer than over-the-counter drugs 14 you can buy in the supermarket. I have seen patients die () 15 from aspirin, from Tylenol. I once had a baby that died of 16 a vitamin A overdose. I had a patient die from drinking too 17 much water. 18 It's amazing what can really kill you. 19 Radiopharmaceuticals don't. When you're looking at risk of 20' drugs, these are not risky drugs. 21 I'm just talking about nuclear medicine, not 22 radiation oncology. 23= And then just one comment on perceived risk. I 24 ~believe it is the job of the NRC and the knowledgeable 25 regulated community to put together risk analysis based on
~/ ANN RILEY & ASSOCIATES, LTD. \- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 110 ' 1 science. Obviously, there are people whose perceptions of
/~T
( ) 2 risk are not based on scientific facts. l v 3 They are a problem in that they need to be 4 educated, but if we set the radiation risks in this country 5 at the level that Greenpeace wants, we all might as well go 6 home, because we're not even going to have a field. So look 7 at perceived risk as a force to be reckoned with, education 8 to be done, but not as a basis for setting risks. 9 Thank you. 10 MR. CAMERON: Thanks, Carol. While we go to Terry 11 Johnson here, I just would like to pose a question for John 12 Whyte from HCFA relative to Roy Brown's comment. 13 How does HCFA, if at all, take into account 14 government regulations and whether they're risk informed, et 73 15 () cetera, et cetera, in deciding how to set practice 16 reimbursement? While you're thinking about that, if indeed 17 there is an answer to it, let's go to Terry. 18 MR. JOHNSON: Somebody asked the question if the 19 NRC had ever done that equation, and I happen to know they 20 have. Early on in the use of the misadministration rule, 21 the NRC did gather data acd they found that for both nuclear 22 mqdicine administrations and radiation oncology 23 administrations, there was an error rate of roughly 24 ten-to-the-minus-four. 25 That wasn't a negative outcome, that was simply an [3 (_,) ANN RILEY & ASSOCIATES, LTD. Court Reporters 3 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
111 1 error. They may have underestimated it. In fact, I think (/ T 2 in nuclear medicine, they very likely underestimated it, but w 3 still it's a very low number. And that's the method they 4 used. 5 Now, that is an unacceptable number when it comes 6 to nuclear power regulation. They customarily will close a 7 plant down in a heartbeat if they thought there was a risk 8 of a serious problem that was as high as 9 ten-to-the-minus-four, and that's the standard that they 10 applied to medicine. 11 Now, actually, there were studies done about that 12 same time-frame -- that data if from 1989 and '88, I 13 believe. There were studies about that same time-frame . 14 about how often ordinarp drugs were misadministered on the p) (, 15 wards of hospitals and there, there was an error rate of ten 16 percent in some studies and as high as 30 percent in other 17 studies, where the medicine was given at the wrong time of 18 day, the wrong patient or in the wrong dosage, or whether it 19 was the wrong medicine or some error, very similar to the 20 errors that are countered as misadministrations when they 21 are radiation-based. 22 . MR. CAMERON: Was there any rationale for why the 23 error rate was lower in nuclear medicine than in the general 24 medicine area? 25 MR. JOHNSON: Well, that may have been a result 'O ANN RILEY & ASSOCIATES, LTD. w- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
112 1 partly of NRC activities, but still it was striving for a () 3 2 standard that was excessively high standard compared to the practice'of medicine in general. 4 MR. CAMERON: I guess that goes to trying to 5' separate out what can be attributable to NRC regulatory 6 framework versus perhaps standards of practice in the field, 7 which'we'll get to this afternoon. 8 John, do you have any comment on the economic 9 issues? 10 MR. WHYTE: I'm going to give you my impression 11 and then I'm going to look to my colleague, Sharon Hippler, 12 to correct me if I misspeak, since payment is in a different 13- group at HCFA than we're at, which is the coverage group. 14 But the way that I would answer the question, and
~ 15' I'll; check for sure and get back to you, is as you know, 16 payment deals with issues of relative value and there are 17 different components that go into that, such as medical 18 liability, geographic variation, and the process expenses, 19 what you'had referred to.
20 I would not envision costs associated with 21 regulation being factored into those calculations, partly
'22 because they would be difficult to ascertain and they -- I 23 don't chink HCFA would really interpret that in the
'24. definition of practice expenses. I'm just going to look to 25 Sharon to see if she agrees.
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l j.1 l 113 1 MS. HIPPLER: I think maybe basically that's true. 2 However, every time HCFA issues a regulation, we do have to 3 do what's called an impact analysis and I think basically 4 what that consists of is looking at the direct costs to the 5 regulation's targeted population and seeing if it's offset 6- anywhere by savings to that same population. 7 Those factors are included in any regulation that ! 8 we issue. 9 MR. CAMERON: Thanks, Sharon. Thanks, John. We 3 10 really are running over time here and Bill has had his card 11 up. I'd like to take him and Roy, if you have a real, real 12 ! ( quick comment after that, because we need to see if anybody I 13 out here has some comments before we break for lunch. 14 Bill? i 15
'( ) MR. VAN DECKER: Thank you for the opportunity. I '
16 just wanted to quickly reemphasize and develop two thoughts 17 that1I thought were important. One, I wanted to applaud Dr. 18 Marcus for what I thought was an excellent presentation on
~
i 19 -come key issues, and then I want to talk a little bit about 20 what Roy Brown was talking about. l 21 I think that obviously risk is always an issue 22 that is difficult to get a hand on and it's because l 23 especially in this environment, we're not dealing with the
' 24 other half c f the equation so easily that medical practice 25 deals with every day. . /g ANN RILEY & ASSOCIATES, LTD.
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e 114 1 And that's not so much risk analysis or risk-risk 2 ' issues, but risk-benefit issues. In that regard, we're
)
3 basically talking about benefit to health care society and 4 health care individual patients and then we're dealing about 5 risk to occupational workers and general public and those 6 are obviously a little bit different in their steeds. 7 However, obviously, with the current environment, 8 cost-effectiveness and health care outcomes of patients 9 becomes a big issue and how you define those issues and how ' 10 much benefit you get out may be worth bypassing somebody at 11 a 15 percent risk if that gives them the highest benefit. i
~12 It may'not be acceptable to have a one percent death from .
13 suturing a cut on an arm. 14 So some of that is all part of the issues that () 15 need to be involved in this. Somebody brought up the issue 16 and risk issues about regular pharmacies. Obviously, if you 17 define a misadministration a regular pharmacy has delivering
.18 a beta blocker at 11:00 in the morning rather than at 10:00 19 in the morning and you try to regulate that, you're going to 20 put a lot of cost on the system and a lot of needless issues 21 that have no overall outcome on the patient's overall care 22- or down the line issues.
23 So there are some things that we would prefer to 24 see done more stricter or better, but that are not within 4 - 25 the realms of the-resources that we have available. ANN RILEY & ASSOCIATES, LTD. \ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
115 ! 1 Therefore, I think there is regulatory risk and that's the
] 2- risk of getting no benefit out of procedure and, therefore, 3' you have the concerns of other procedures being seen as 4 safer, even if they involve other forms of ionizing 5 radiation, issues of things being easier to utilize because 6 of the restrictions that shift things, not on a clinical 7 basis for patient care, but because of systems we've put l i
8 into place or things that are, therefore, cheaper. ' 9 I think that all of that is all part of that issue 10 that needs to come into play. 11 The last part of the comment I wanted to just talk 12 about was this business about regulatory cost and 11 3 prescription of the output. Obviously, HCFA and the APCS is r~ 14 ' widely into this part right now, we hear a lot of this, and (\) 15 I'm sure that we look forward to hearing from them, their 16 more defined thoughts on the process. 17 But right now, we are redefining how we're 18 delivering health care and how many bodies it takes and 19 where we have resources to do it, because the government and 20 society has asked us to do that. Therefore, we have.to 21- decide where we have to be doing things for the betterment l 22 of the patients down the line, and I think that's an 23 important part of this discussion. 24 My last comment goes to something that Dr. Marks 25 brought up, which was if the rule is working for protecting !' ()
\_/
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i i 116 ; 1 the occupational worker and the general public at present, I i () 2
.3-then_why worry about_ fixing it. I fully accept his comments i
that there has been excellent safety requirements -- ' 4 excellent safety record to date in this regard. 5 But if we're over-prescriptive in what we're doing j t i 6 4 and we could be having the exact same safety record with ! 7 much less, than we will be doing the health care system a l 8- tremendous, tremendous benefit in the current era, and I- ; 9' think that those are the types of things that we need to be } 10 considering as far as access to patient care and benefits to 11 society as a whole in the future. 12 MR. CAMERON: Thanks, John. I think that last > l 13 point was at least part of the motivation for the revision 14 of Part 35-that's going on now. '/~T 15 l(,,/ Roy, did you have a quick point before we go to 16 the-audience? i l l- 17- MR. BROWN: No , that's all right. 18 MR. CAMERON: Bill, what was that acronym you used 19- in relationship to HCFA APC? What was that? 20 MR. VAN DECKER: Are you asking me to define 21 something I'm supposed to understand? It stands for 22 ambulatory payment groupings and it's a new -- it's actually 23 a rule under commentary from HCFA right now for 24 reimbursement for hospital outpatient procedures that now 25 bundles the total payment of the procedure into a lump sum L i [ ANN RILEY &' ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,'D.C. 20036 (202) 842-0034
l l 117 1- and you can no longer divide out potentially ; ('T) 2 radiopharmaceuticals or radiation safety portions of the ;
- -3 payment. t 4 You have a certain sum on which to work.
5 MR. CAMERON: Thank you very much for that. Let's t 6 go to the audience. Anybody out here have a comment or a i 7 question on our risk discussion? l 8 MS. CROFT: I am Barbara Croft, currently working 9 for the NIH. This comment does not come from the NIH. It i 10' comes from me. 11 I have.two actual points to make. One is that'we l 12 are looking at risk in two, I suspect, very different points l l 13 of view. You could start with a new procedure and say, i 14 okay, what are all the awful things that could happen in the 0) (_ 15 course of this; I can get the wrong -- I can make the wrong. I 16' radiopharmaceutical, I can take the radiopharmaceutical out 17 of the wrong jar and stick it in the ann of the wrong 18 l patient, I can put it into that patient's arm instead of the 19 vein, et cetera, et cetera, et cetera, or we can look at 20 this from the point of view of the performance of the 21 industry, which now has a long history, not a short one, and 22 so we are not starting from the very first reactor and i 23 wondering where the problems are going to be with that 24 . reactor. 25 We're starting from a long history of nuclear l I-
/ h ANN RILEY & ASSOCIATES, LTD. , k~) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,.D.C. 20036 (202) 842-0034
118 1 medicine. ()' 2 3 The other point that I wanted to make, and it's relevant to something that somebody said, is that we're not 4 talking about the population at the fence or even in the 5 city nearest a nuclear reactor when we are talking about 6 difficulties and accidents. So we're not multiplying 7 difficulties at Calvert Cliffs and Surry to the population 8 of Richmond and Washing. We are actually talking about this 9 as a patient by patient, one on one encounter. 10 So we're not talking about the same kind of 11 difficulties that occur if you release a small amount of 12 radiation and multiply it by a large number. We're talking 13 about, in fact, sometimes a very moderate amount of "14 radiation and one patient at a time. I 15 So I think it's very important to remember that
- 16. these multiplication issues have to be approached in a 17 'different kind of way.
18 Thank you. 19 MR. CAMERON: Thanks for underlining that 20 difference, Barbara. Anybody else out here? Felix? 21 MR. KILLAR: I'm Felix Killar with the Nuclear 22 . Energy Institute. I'd like to provide a little bit of 23 different perspective from the Nuclear Energy Institute. We
. 24 . deal with all aspects of nuclear energy, from power plants 25 to nuclear medicine to well logging and things along that I - \
ANN RILEY & ASSOCIATES, LTD. ws Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l
119 4 1 line, and I think Don Cool said it best when he talked about
- 2 . risk earlier.
G. 3 In all of the other parts of the NRC's 4 regulations, you're dealing with keeping the radiation away . 5 from individuals, you provide the shielding, protection, 6 distance and things along that line. 7 There is only in Part 35 -- there's only been part 8 of Part 35 that you're dealing with the interaction of a [ 9 person with the radiation. I think that should state a loud I l 10 message to the NRC that maybe this is an area it shouldn't ! 11 be in. ,
~12 Because what they're trying to do in all the other I 13 parts is to keep the radiation away from the people. In 14 this part, the radiation is being induced,
, () i 15 There are other agencies that are very-t 16 knowledgeable in handling this. The Food and Drug 17 Administration, you have your medical boards, you have L 18 radiopharmaceutical boards, those are the agencies that deal l 19 with the interaction of a patient and the radiation and the
'20 drugs and those are the appropriate ones there.
1 21 And one of the things I see at this meeting here 22 is that you don't have a representative of FDA here or the 23 medical boards or the radiopharmaceutical boards, and I 24 think that's one stakeholder that should be here, because ! 25 they're specifically in the area that Dr. Marcus pointed out 4 i. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
120 1 is the dual regulation aspect.
/~\ 2 MR. CAMERON: We do have representatives of the b 3 Federation of State Medical Boards with us at San Francisco.
4 So we did get that input and although the FDA was invited to 5 all three of the meetings, we haven't seen them yet. 6 But perhaps we can have a discussion of that this 7 afternoon about how their regulations interplay with ours. 8 Anybody else in the audience that has a comment? 9 Myron? Then I think we'll take a break for lunch. 10 MR. POLYCOVE: I'm Myron Polycove. I was part of 11 the working group involved in this revision. 12 It seems to me that we could be most productive in 13 this workshop if we tried to make our comments very 14 specific. For example, I think Carol's focusing on DPM at im
%/
) 15 the removal down to 20 DPM per 100 square centimeter, that 16 in the guidance is admittedly, to me at least, absurd. And 17 things like that should be specifically focused on.
18 Other areas that could be focused on would be the 19 dose limits. For instance, if we're all agreed that in 20 nuclear medicine, risk is very, very low, then we've seen 21 that the necessity for having plus or minus 20 percent is 22 not relevant. 23 So that I think the more specific we can be to 24 clean up the proposed rule, the more productive we will be. . 25 MR. CAMERON: Thanks, Myron. That was a good / I' ANN RILEY & ASSOCIATES, LTD. g (._ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 ! l 4
. . ~. ~ ~ - - . . . . . _ . - - ~ . . - , . . . - . -
121 1 point, that the more detailed'we get, at least somewhere in
?(~')'
2 'the process, in the written comments or in any other [ 3 get-togethers like this that might happen, that's obviously 4 going to be helpful. i 5 We're going.to break for lunch now and take an 6 hour for lunch, come.back at 25 to two. We're a half-hour 7 behind. And I think people want to know where lunch is
-8 going to be.
9 If you go up to the next level, you can take an i 10 elevator upstairs. Cathy, this is right, they can get 11 access to the cafeteria. l 12 Next floor up is the cafeteria. They have 13 anything you might need there. ! 14 Thank you. !
- (/}j 15 And we have some new additions, that when we }
16 re-adjourn or reconvene, we'll have them introduce
.17 themselves.
18 [Whereupon, at 12:35 a.m., the meeting was 19 recessed, to reconvene at 1:35 p.m., this same day.] 20 L 21 l 22 .
"23 24 L 25
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l 122 1 AFTERNOON SESSION
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{} 2 (1:35 p.m.] 3 MR. CAMERON: If we could get everybody back to I 4 the table. We're running 45 minutes behind schedule. 5 ~ We're going to go into our second main discussion
]
6 area in a minute. I guess I would just give you a 1 7 simple-minded summary from this morning. 1 8 It seemed pretty -- I don't want to use the word j 9 unanimous, but there seemed to be a lot of feeling from 10 . people around the table that there is a further need for 11 risk data in terms of the proposed rule and also that there 12 is more time needed for meaningful comment on the proposed ! i 13 rule, and, in fact, those may be related. ) 14- Before we get started, I wanted to have some new 1 i
.V- - 15 . additions to the panel introduce themselves and just tell 16 their affiliation. David? '
! i l 17 MR. KRAUSE: My name is David Krause. I'm a ! 18 radiation oncologist and director of governmental relations l I j 19 for the American College of Radiation Oncology. I come from l 20 Lansing, Michigan. 21 MR. CAMERON: Thank you very much,. David. 22 . We do have copies of Carol Marcus' slides outside 23 and we are getting copies made of some comments that Dr. 24 Subir Nag prepared and they will be outside later on. 25 We also have copies that we'll be handing out of a 4 l ['--'} ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034 i
123 1 presentation that was made in Kansas City by the American (N-)) 2 College of Radiology and Society of Nuclear Medicine and a 3 couple of other organizations in terms of an accreditation 4 program. You will see that listed as your first bullet at 5 the 1:00 time slot, a proposal from the medical community. 6 That's a specific proposal and I thought it might 7 be useful to perhaps give this a more general context, this 8 particular area. So we're going to start out with one of
'9 the draft provisions in the medical policy statement that !
10 has to do with consensus standards. You can see that it l 11 says the NRC, in developing a specific regulatory approach, 12 will consider industry and professional standards that 13 define acceptable approaches at achieving radiation safety. l
. 14 There are two aspects of the industry and '( j 15 professional standards issue. It's not just that the NRC 16 will incorporate those standards into our regulation, but 17 perhaps more importantly, from the medical community's point l 18 of view, that would defer from regulating in a particular 19 area if professional standards existed. .
l 20 What we want to talk about is what are those I 21 standards, where do they exist, is there anything that, for 22 example, the Joint Commission does, and Shelby is with us 23 here today from the Joint Commission, that might alleviate 24 the need for NRC regulation in certain areas and how are we 25 to be, at the NRC, assured of that. ID ANN RILEY & ASSOCIATES, LTD. k/~ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
124 1 There-was a lot of discussion of this issue of 2- voluntary standards in the proposed rule, in what's called 3 the supplementary information to the rule, which is the 4 explanation at the beginning, before the text of the rule. ! 5 There was discussion there and there.was also a l l i 6 lot of discussion obviously in the draft or the proposed ; [. 7 medical policy statement about this issue, because there is l 8 a specific item on that. I don't want to open up the whole l 9 medical policy statement to discussion now. We may have 10 time to get into that later, because I know there's a lot of l 11 issues there, but maybe this would be a good point. 12 Does anybody want to --'we've heard some on the l 13 voluntary standards issue. Does anybody want to lead off 14- with sort of where are the -- where are the standards of ! () 15 practice in the medical community, how does the NRC become 16 aware of-those, where should we defer'to' standards of 17' practice?
>18 Shelby, I don't know if you want to just give us a 19- .little description of what the Joint Commission does and how 20 that-may be relevant to this, but if you would now, that' '
1 21 would be terrific. 22 - MS. DUNSTER: It definitely points to relevancy, 23- but I think there are some constraints on that. The Joint
~24 Commission has environment care standards that look at the 25 handling and management of hazardous materials. ~[
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125 1 Those standards defer to the Nuclear Regulatory (/"~~) 2 Commission and we would look for conformance with NRC's x_/ 3 regulations as part of the Commission's overall requirements 4 that an organization be in compliance with applicable law 5 and regulation. 6 From what little I have heard, one area that I 7 would be interested in hearing people talk about is the 8 issue of credentialing. This is an area where the Joint 9 Commission has very specific standards that we look at and 10 it sounds as though some concern has been raised, in some of 11 the material I've read and the little I've heard this 12 morning, that that may be an area where there may be some 13 duplication of effort. 14 When you're talking about professional standards r-k3l m 15 of practice, that really isn't an area that the Joint 16 Commission is looking at in the course of an accreditation 17 survey. 18 We're looking at processes that go across the 19 organization and patient care functions, functions that 20 support the environment of care functions, but we're not 23 g actually evaluating any particular professional standards of b 22 practice. 23 So I don't know if that clarifies how far we'd go 24 with certain things. 25 But the one area that strikes me first is the fh () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
126 1 whole area possibly of credentialing, medical staff
/1 b/
2 credentialing, competent assessment of people who are not 3 licensed independent practitioners. 4 MR. CAMERON: When you say there may be some 5 duplication, you're saying that one area where you just 6 don't defer -- I mean, you defer to NRC standards perhaps 7 not -- maybe even specifically, but that there may be things 8 that you do in credentialing that overlaps with the NRC's 9 credentialing requirements and I would have to ask the staff i 10 whether we're talking about'the training and experience 11 requirements in these regard. 12 MS. DUNSTER: That's would be the closest thing in 13 the rules to the credentialing requirements, but there's a 14 little bit of difference, especially being drawn in this l
-rN t
) 15 rule-making and we'll get into tomorrow, is that the ,
16 authorized user status is only saying that the individual is : 17 competent to handle radiation safety. 18 The radiation safety aspects of the material, but 19 we're not making any assessments whatsoever on the clinical 3 20 competency of the physician. So when we get into talking 21' about the areas where JCAHO is looking at, we have to be l 1 22 very careful whether we're talking clinical competency or 23 ability to handle material safely. l 24 MR. CAMERON: Is the clinical competency the area 25 that the Joint Commission gets into? j O ANN RILEY & ASSOCIATES, LTD.
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_ - _ _ . . . _ m _ _ _ . _ . . _ _. _ _ . . . _ _ . . . _ . - .. . _ _ _ . _ . 127 1 MS. DUNSTER: Yes. () 2 3 then. MR. CAMERON: Okay. That's a good distinction I l 4 MS. DUNSTER: Right. 1 5 MR. CAMERON: 'Carlos? l 6 MR. HAMILTON: This whole issue is one that is I 7 really important to physicians and to the organization that
;8- we wo_-k with, because being able to document and to certify, 9 if you will, a physician's clinical competency in a certain 1 i
10 skill or a certain area is something that is obviously 11 expanding and will continue to do so. 12 It is my understanding that the interventional ' 13 cardiologists.are going to have a separate board that will i l s 14- ~be-coming on line just in the very near future and multiple s_) ' 15 pieces of various other subspecialties are going to continue l 16 to need to be certified, f 17- This is an area that is currently not being ' 18 certified by any professional organization, but there is a i 19 need for it at least in terms of endocrinology and that is 20 one of the things that we have been discussing among 21 ourselves today and yesterday, the need for our various 22 organizations to come together, put together the l 23 certification program, if you will, that will certainly meet l 24 the needs of the NRC in terms of the safety of the use of j l 25 radioisotopes in the treatment of thyroid disease, but also t-h)' ANN RILEY & ASSOCIATES, LTD. Sd Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l l . . 1
l 128 1 cover the ability of physicians to do the proper clinical
.(A -2 competence testing.
3' This is an important area, one where we have not 4 gotten into it in great detail, but I can assure you we ) 5 will. l 6 MR. CAMERON: And we will be discussing something I. 7 similar in a few minutes, the proposal that the medical 4 8 community developed for presentation at Kansas City on i , 9 accreditation programs. [ 10 But to be a little bit more macro here, Carol, we 1L1 heard you talk about what you called dual regulation and you d 12 not only included other agencies, but perhaps other what we 13 talk about as voluntary industry and professional standards. 14 So I guess what I'd like to find out is are there () -15 specific areas -- can you point to specific areas in the 16 proposed rule, not maybe specific provisions, but the ! 17 specific areas where there is a industry and professional l 18 standard that might satisfy the objective of the NRC's 19 regulatory program. 20 In other words, do we need to go there or do we i 21 need to go there in as much detail as we do. 4 22 - MS. MARCUS: Well, there are a number of issues, 23 and having just added them up just right now. But when the 24 NRC decides to tell us when we should and should not write a 25 prescription and what constitutes a prescription, and how to
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l I 129 1 identify a patient, these are things that are professional i _ () N. / 2 standards, that are well understood by professionals, and, 3 in fact, there are certain things that are done verbally and 4 approximately and there's flexibility in there. 5 Are other things that are done very exactly -- it ) 6 depends on the procedure, it depends on the situations, it 7 depends on the tolerance of the procedure for the patient. 8 The radiation oncologist may feel that plus or minus 20 9 percent in a dose is a very big variation. A nuclear 10 medicine physician may feel for diagnosis that often plus or 11 minus 100 percent is perfectly acceptable or even more; that 12 if you infiltrate a dose and give another one, that's 13 perfectly okay, and if the patient weighs 450 pounds, 300
. 14 percent is perfectly okay.
i (m,) 15 If the patient has another isotope on board and 16 you have to give extra to overcome it in order to get the 17 counts correctly in the procedure, so you swap it. So it's 18 a lot more casual. 19 A lot of things are done verbally. The NRC will 20 not accept anything that does not have written 21 documentation, and this gets in the way of the professional 22 standards. 23 The unusual situation in which a wrong patient 24 gets something really tells you that professional standard 25 is to identify the patient. I already thought it was ( ) ANN RILEY & ASSOCIATES, LTD.
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l l i 130 1 amazing to see NRC's list of acceptable ways to identify a () 2 patient and recognizing them wasn't one of them. l 3 I mean, you're a doctor taking care of people. 4 'When my patients walk in, I very frequently call them by l 5 their name because I know them. I don't ask to see their , 6 social security number or their driver's license or anything t. 7 like'that. I just know them. 8 I object to this kind of dual regulation because
- 9 it is part of professional standards. These are'not 1 i i 10 voluntary professional standards. I do not decide whether I 11 want to identify patients or not, because the Board of l
12 ' Medicine is going to hold me to the standard of medical l practice. It really isn't voluntary at all, except'that l 13_ I
- 14 keeping my ability to practice medicine is voluntary.
('
'h
(,,) 15 So really the things that other members of the 16 group do define what you are expected to do and this is what , l 17 you are held to when the Board of Medicine reviews your j i 18 practice. 1 l 19 MR. CAMERON: Let me ask you something about that. l
.l 20 I think that in past workshops, we've heard about standards i
- 21. of practice in particular areas that were a lot more l 22 detailed than, for example, basics such as identification of
'23 patients.
24' When you say that there is a professional l 25 -standard, ;ou're talking about sort of generally what a )
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l 131 l 1 1 state cedical board would expect of a physician as ' f'~s 2 reasonable behavior. (x-) ! 3 I'm just trying to get a cite, for example. l 4 MS. MARCUS: For example, I am a consultant to the
)
5 California Medical Board for malpractice investigations 6 involving nuclear medicine, and the question they ask me is 7 what this guy did within the accepted standard of practice 8 in your specialty. 9 And if it was an OB/GYN case, they'd get some 10 OB/GYN doctors and ask them that question. So they aren't 11 written down. It's a continual evolution of practice, but I 12 think professionals have a good idea of what constitutes 13 appropriate practice. 14 When the NRC has something like a patient C)\ ( 15 notification rule, where the NRC tells you that if you're 16 over 20 percent, you've committed a sin and you have to tell i 17 the patients, and I can tell you that it isn't a sin and I'm i 18 not going to tell my patients that I've sinned when I l 19 haven't. 20 This gets into a situation where the NRC won't 21 even accept the medical standard of practice, but it has 22 arbitrarily and capriciously defined sin where it doesn't 23 even exist. 24 MR. CAMERON: Let's get some other examples of 25 provisions where we do have industry and professional h') A-ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
132 1 standards. Is it something that's written down somewhere or I /m. (J.) 2 is it something that's just part of what is judged to be an 3 acceptable standard of conduct? 4 Jim? 5 MR. MARKS: Yes. I believe it's written down. I 6 have a little trouble with the term industrial standard. 7 That's a business term, it seems to me. I think Dr. Marcus 8 is exactly right, we are really dealing with professional 9 standards here. I'm going to read to you a short excerpt, 10 for brevity's sake, that I read to you the last time I was 11 here. 12 I think you will find the industrial standards for 13 my specialty and the special requirements in the green book, 14 ACGME accreditation of internships and residency programs in k-) s 15 this country, in answer to your question, what are they. 16 The statement is while I have great respect for 17 the NRC and the job that it has done in safely regulating 18 the diagnostic and therapeutic use of radiation, it seems to 19 me they have stepped over the bounds of regulation into the 20 domains of accreditation and certification. While the NRC 21 has the right to specify that authorized users, like myself 22 and Dr. Marcus, be qualified in terms of training and 23 experience, they are not in position to provide the training 24 or to document that the individual is adequately trained. 25 Only those institutions accredited by ACGME are
,- m
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l 133 I 1 qualified to provide instruction and experience in the 1 i 1 [~') A/ 2 diagnostic or therapeutic administration of radiation. 3 Normally, the American Board of Radiology or its equivalent l l 4 is capable of certifying that an individual is adequately I 5 trained to be an authorized user of fission byproduct 6 material. , 7 MR. CAMERON: Thank you, Jim. Subir? I 8 MR. NAG: You had asked whether there are specific 9 standards that are published, and there are some. There are 10 perhaps not enough. I think we, as professional societies, 11 need more standards, but, for example, the American College 12 of Radiology has standards set up on the American 13 Brachytherapy Society and we have published a few guidelines 14 on the use of high dose rate brachytherapy and use of g i j 15 prostate brachytherapy, and these have either been published 16 or are in the process of being published. 17 The other standards that would be set down are by 18 textbook, and, again, we do have now a couple of textbooks 19 on brachytherapy and all these do set up standards in 20 brachytherapy, and that is what most practicing radiation 21 oncologists use as their standards to follow that. 22 . Therefore, I think what you can do is, A, look at 23 these standards and, B, have the professionals from these 24 boards, like American Brachytherapy Society, ACRO, American 25 College of Radiology and Oncology, to help you make up your [] ANN RILEY & ASSOCIATES, LTD. \_/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ( '. 0 2 ) 842-0034
134 1 guidelines rather than arbitrarily making it up yourself. I'~ 2 MR. CAMERON: (T! Thank you, Subir. I was going to 3 ask Cathy to what extent we've looked at some things like 4 the ABS standards in putting together the rule. 5 MS. HANEY: During the rule-making process, the 6 working group did look at a lot of the standards. We looked 7 at the ones from the American Board of Physicists and 8 Medicine, the American Board of Radiology, Society of 9 Nuclear Medicine, ACNP, anything that would look like a 10 standard of practice, standard of care, we tried to get a 11 hold of and look at, and then we discussed how we would 12 incorporate that into the rule-making. 13 Obviously, one of the main ways would be to just 14 reference it, but we received a lot of comment that that was ( (~ /; 15 not the best way to use it, because by just referencing it, 16 there are things that are in those standards or whatever you 17 want to call the document that go beyond NRC's regulatory 18 and statutory authority or beyond where it's necessary for 19 NRC to be. 20 A lot of them go into the quality 21 assurance / quality control sorts of things and we were 22 advised by the public, you know, don't go there, don't put 23 us into QA/QC, only pick the requirements that you have 24 authority over. 25 Another way is to just not have a regulation at
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135 1 all if the standard is out there, but we took the approach () ( ,/ 2' that -- I think it came up earlier -- that we're regulating 1 l l 3 a broad range of licensees. Most of the individuals here 4 are from very large facilities where they have very 5 established radiation safety programs. 6 We're responsible for regulating the small doctor 1 7 offices in the middle of nowhere that may not be as familiar 8 with the standards of care, standards of practice that the } 9 individuals should be. 10 So we took those standards and we went through ! 11 them and picked out what we thought were important to ; 12 radiation safety and only those elemento did we pull into 13 the rule. l 14 h Now, some could argue that maybe we pulled too ' (N tv) 15 much in and hopefully during this meeting, during the 16 comment period, tu'll hear the cases where we pulled too 1 17 much in, i l 18 But least that was, as I said, the approach that 19 the working group took to formulating the proposed rule. j 20 MR. CAMERON: To some extent, then, we've done 21 this. 22 , MS. HANEY: Right. We have looked at them, 23 exactly, and the question could be should we -- was it 24 needed, necessary to pull in the requirements that we pulled 25 in in light of the fact that these professional standards l l i i ANN RILEY & ASSOCIATES, LTD. ((N Court Reporters ( 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 (202) 842-0034
-~ . _ . - .. - . ~ . -- . . ~.
136 1 existed and we felt that for the reasons. stated before, that t,/-~I 2 we needed to pull the key elements for safety into the rule D 3 'and then that gave the licensee flexibility on adopting any 4 other parts of the standard that would go into the QA/QC 5 arena. - 6 The other thing that we tried to do with the 7 rule-making was toward the approach of making it more L 8 performance-based, was to give the licensee the. flexibility 9 of how they accomplished certain tasks and, hence, what i 10 really got us in a lot of the cases where we said develop, 11 implement and maintain procedures that will do the 12 following. 13 And that was our attempt at recognizing that those 14 industry standards are out there, that those would be a very i
/~'s j 4,,)
15 acceptable mechanism for meeting the requirement. 1 16 MR. CAMERON: Okay. Thank you. Marleen? l-17- MS. MOORE: This is to raise a concern that I have
, 18 that we do keep talking about professional standards', and L
19- yet we all know that in the medical community, there are 20' those who are not professionals and our concern is that 21 without something, and I'm not saying it should be a Part 22 35, but I'm saying that there needs to be something out i 23 . there that helps to ensure that the person who, in fact, 24- does not have training to -- while using the radioactive 25 1 material, doesn't go through 120 hours exam, which all of I i -- ' 's/ h): ANN RILEY & ASSOCIATES, LTD. Court Reporters
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137 1 you are wonderful at taking, and be able to get the i
,m ; ) 2 qualification out of the other professional characteristics. I
- s. s 3 MR. CAMERON: Thanks, Marleen. Let's got Dr. Van 4 Decker.
l 5 MR. VAN DECKER: I just wanted to make a couple of i 6 organizational comments here. A lot of the comments being 7 made around the table right now are exceedingly important I 8 comments which need to come out, but my construct of the ' 9 agenda for the meeting is that those comments are basically 1 10' the part of tomorrow morning and that there was another 11 intention for this slot here right now. l 12 I just -- it doesn't necessarily have to be that 13 way, but I just want to make sure that we understand what 14 we're talking about. I mean, one is obviously the p ( ,) 15 professional standards of training and experience of a 16 physician to be an authorized user. And obviously the thin 17 line of how you make that assumption on the basis of 18 radiation safety knowledge alone instead of out of the realm 19 of clinical competence of delivery of health care to a 20 patient, in which case, the majority of the time, the final 21 decider on that ends up being outcome and patient and 22 referring physician based, versus accreditation of the 23 standards of how a hospital practice or an outpatient 24 practice works in delivering that authorized user or 25 allowing that authorized user to work. l /~s (' ) ANN RILEY & ASSOCIATES, LTD.
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138 1 1 And I think that because there's a lot of people l l/h \yt 2 'that want to be at this table, we should keep those T&E j 3 comments until tomorrow morning, so that everyone is here
- -4 who has comments to make.
1 l 5 My understanding at least of the section that's on { I 6 the table right now came up from the Kansas City meeting and l 7 my understanding of the discussion involved at that time had 8 been whether there could be professional standards among the 9 authorized user-community that would allow the NRC to be 10 less prescriptive in its enforcement and oversight, 11 regulation and site visits that the community could show 12 that it was indeed being regulated by JCAHO in that regard 13 or by other organizations or that there were other internal 14 standards to take those into place. 15 ( ) I don't consider myself an expert in that area of 16 accreditation type stuff, but I do know that there are 17 multiple efforts being made by multiple organizations to 18 'come up with accreditation type programs to show that type
- 19. of competence. Those programs obviously are based not only 20 on the radiation safety portion, but also on some clinical 21 portions, and obviously it will remain to be seen how they 22 all play out for the well being of all, both the patient and 23 the safety to the occupational worker and general public.
24 But I think that's the very process that they're 25 going on proves that there is a strong cammitment on the
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139 1 basis of all the physicians involved in the health care 2 delivery to do something and to try to help in this regard 3 in making sure that'a singular standard is maintained or 4 standard across multiple cross-cutting lines. 5 MR. CAMERON: Okay. Thank you, Bill. We are 6 going to get to that specific proposal on accreditation in a 7 minute. Charlie Showalter is going to summarize it for us. 8 But the professional standards issue applies to 9 T&E, training and experience, it applies to a lot of 10 different areas and we may repeat some of that tomorrow in 11 terms of training and experience. 12 .But this particular section is to try to address 13 the general concept as embodied in the draft medical policy 14 statement of people talk about professional standards; well, 15 where could the NRC improve this rule-making in light of V[ T - 16 professional standards. 17 Aubrey, you put your card down. Did you want to 18 say anything? 19 MR. GODWIN: Well, I'm afraid my comments may be 20 more on the training and experience end of it, and it might 21 be better to hold them till tomorrow. 22 , MR. CAMERON: Okay. 23 MR. GODWIN: One general comment. Again, not all 24 facilities have accreditation programs that we deal with.
- 25. So, that's one of the things we do have to look at as we go
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140
- 1. through this system.
() 2 MR. CAMERON: Okay. Thank you, Aubrey, and we'll 3 hear more about that tomorrow. 4 Bob? 5 MR. ZOON: Yes. Thank you. 6 I would like to. talk from the perspective of 7 radiation protection specialists and radiation protection 8 programs. 9 I think that there is -- unquestionably, the 10 knowledge of radiation, its hazards, and methods of 11 protection'against it are one of the most well-known 12 disciplines in this arena of any hazardous material. 13 We have, of course, with respect to the protection 14 of employees and members of the general public -- and I 15 consider patients members of the general public -- the 16 standards of 10 CFR 20, and I don't think that, if 10 CFR 35 17 didn't exist, that anybody would be protected to any less 18 degree of excellence than they currently are. 19 We have, surrounding that, all the principles, 20 practices, etcetera, recommended for radiation protection 21 programs. 22 .. We have the recommendations of the National 23 Council on Radiation Protection, the ICRP, the Health 24 Physics Society, and I know a lot of HPs, obviously, I know 25 a lot of radiation protection-programs. I don't know of any (~'j\
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_ _ . . . . . - - . - - - - ~ . - - . . _ _ - . - . - . - _ - . . _ . . - . . , - - . 141 1 whose objective isn't to protect everybody to the best I'V ) 2 degree possible. 3 So, I would argue, if you're looking for 4 standards, they're out there, and they're out there in [ 5 spades, okay? ) 6 I would argue on the basis of this society that l 7 the prime directive in the practice of medicine is the 8 welfare and' safety of the patient. That's the physician's 9 mission, and it's the position of the radiation protection 10 specialist to protect everyone involved against.the effects l 11 of radiation. ' 12 So, I'd like to get that on the record. 13- MR. CAMERON: We're going to go to Jim Deye here, 14 but his earld.er comment may be relevant in terms of (O) 15. occupational safety versus patient safety. 16 I wondered, if there are these professional ! 17 standards out there and the general admonition to the 18 physician to protect the patient, where would you draw the 19 line in terms of what Part 35 should cover or not cover, and 20 I'll go to Jim now, but that's just a question to consider. ) 21 Jim? 22 . MR. DEYE: Well, it's an interesting question.
-23 You've got my mind distracted by it.
24 I think it could be answered with a little bit of 25 thought, but I come back to that defining point, to the
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142 1 . difference between the' patient and the other members of 2' society, be they public or workers.
- g[~)
3 You had asked for a specific example, though it 4 probably falls into tomorrow's discussions. We were 5 reminded a minute ago that medical event -- the whole t 6 concept of medical event, I think, is a specific example of 7 dual regulation a la the other regulatory authorities, be it 8 the board cert.ifications or state medical boards or even the 9 liability courts. ! 1 10 They certainly define medical event in an ongoing l
- 11. way, as we said before.
J 12 There are, of course,. boards out there. You asked !
~ 13 .- for examples, and you've heard a number of them. r 14 ABMP, American Board of Medical Physics, ABR,
() 15 certainly in the physics community, those two boards have 16 standards that hold the physicist to certain minimum 17 requirements with regard to their knowledge of radiation
-18 safety.in a medical environment, to the point where I think 1 19 I understand now that even the Health Physics Society is now {
20 a cosponsor in the medical arena of.the ABMP for medical 21 health physics. 22 . So, there are standards'out there that physicists, 4 23- as well as physicians, then, are held to by our respective 24: boards, and I don't think you have to look very hard for 25 those. i I i l
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143 1 Are they enough? I think not. As I said before, I 2 I think to imply that we could do without Part 35, I think, 3 overstates the case even experientially. l 4 If you look at just the issue of tele-therapy with 5- cobalt units -- and I don't think Riverside, Ohio, would 6 have been obviated by having these standards in place or 7- these regulations in place, but at least calibrations would 8 have been done on a more regular basis. 9 I think the issue of calibrations of equipment is 10 dealt with in a regulatory fashion appropriately by Part 35, 11 and I don't think they're dealt with appropriately in other 12 areas such as Part 20.
' 13 So, there is a rationale for a Part 35, but we 14' need to limit it to those parts of the practice ~that relate
() 15 to general radiation safety, as your own staff says, and not 16 to the parts that might relate to patient-physician I 17 prescription relationships. I i 18 MR. CAMERON: And I guess that's -- how to put a l i 19 circle around those parts is part of the issue here. l 20 Carol? j 21 DR. MARCUS: You mentioned something about you and 22 yqur staff going through a whole slew of professional
. 23 standards and using them as guidance.
24 If you really want to understand the standards, 25 you have to put professionals on your working groups to help I s ANN RILEY & ASSOCIATES, LTD. ! Court Reporters {_ 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 144 l 1 you in?.erpret them. ! [" ')
\- /
2 The interpretation, for example, of the AMA policy l l l 3 for patient notification was hideously poorly interpreted by l 4 the NRC because it was interpreted by people who not i 5 medically competent. 6 So, the first problem is interpreting something in 7 which you're not an expert. i l 8 The second example is where did you get the plus { 9 or minus 20 percent from? That isn't in any medical { 10 standard in nuclear medicine. It's not true for therapy. I 11 We've told you that for 10 years. 12 Now, instead of taking it away when you have an 13 opportunity to justify things on the basis of medical 14 standard and risk, you stick it in for diagnostics, which isi A
!Q 15 intolerable.
16 But that's not in any medical standard. That is , i 17 pure arbitrary and capricious thinking. If you were basing 18 your medical things on standards, could you please tell me l 19 where that came from? 20 MR. CAMERON: Is there a more appropriate place to 21 discuss this specific issue? Because I think some people 22 may be in the dark about what the 20 percent issue is, and i 23 I'm not sure that we've said that everything in the rule was I I' 24 going to be based on some sort of a medical standard. 25 MS. HANEY: We could discuss it tomorrow afternoon l [D
\_)
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L 145 ! '1 when we get into the last session that we have, the 2' performance-based issues. I mean this is one of the 3 subjects we could discuss. 4 MR. CAMERON: Or the reportable events? Okay. 5 Carol, we're going to go into that 20 percent 6 tomorrow. We'll put that up in the paddock as an agenda l- 7 item. , 8- David, did you have a comment? 9- DR. KRAUSE: It was actually just very briefly 10' about Riverside. No matter what that regulation was, that ; 11 'was a fraudulent situation, things were be marked as being-12 done that weren't ever performed. ' 13 So, .the regulation in and of itself didn't prevent i 14 fraud. f fm 15 MR. CAMERON: Okay.
-{) j 16 Let's go to Terry.
17 MR. JOHNSON: Well, I have a general question f i 18 about the agenda before us. I think that these discussions
, 19 about objectives and philosophical matters are important, 20 but I also think that we should have a fair amount of this 21' meeting just devoted to discussing the rule, the proposed
'22 rule, and the wording of the proposed rule, section by 23- 'section.
24 I think that, sometimes, just the choice of one 25 word over another in a rule has enormous impact on licensees i I i . l l1 ANN RILEY & ASSOCIATES, LTD. : [ (\ Court Reporters ) 1025 Connecticut Avenue, NW, Suite 1014 i L Washington, D.C. 20036 (202) 842-0034 4 i i
k 146 1- or anyone else that's regulated, and I'm wondering if that , ( ) 2 will come up during the course of this agenda. 3 MR. CAMERON: It certainly will. As with any 4 workshop.where you have limited time, we're sort of having a 5 mix of broad policy issues here and discussion of specific 6 provisions, and because we've heard before from the medical 7 community about deference to professional standards, we 8 wanted to explore to see whether there were any things 9 specifically -- there was anything specifically in the rule 10 that could be changed because of the existence of 11 professional standards, but we do have specific provisions 12 on the agenda, and we will get to those. 13 Some of those things may have to, of necessity, be 14' the subject of written comments, but we won't ignore the I 15 specific provision. l 16 Aubrey? 17 MR. GODWIN: One of the issues I think we're l 18 stepping around, dancing around, is the issue of whether the 19 NRC should be reviewing the clinical experience of the j 20 physicians. 21 If the decision is made'that they really should 22 not be, then I would submit to you that a lot of the 23 experience, at least a part of the experience section that [ 24 you have in the 900 section, probably needs to drop out, 25 usually the C part. 1 i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 g * -
147 1 For example, if you look at training and I 2 experience for imaging and localization studies and you go V) 3 to the alternate other than certification, you have all this 4 classroom experience, but the last item, C, complete a 5 training program, the medicine has been approved by the 6 council on nuclear medicine, things like that, which would 1 7 presumably get more into the clinical aspect of it than it 8 would the normal safety, because presumably, if he's had 200 9 hours of laboratory training and 500 hours of supervised 10 work experience, he probably ought to know enough about 11 radiation safety by then to question whether you want to 12 continue to ask for this, if you elect that the NRC is not 13 going to look at clinical. J 14 So, that should be something that's a little
,/ m
( ) 15 different, and you find this repeated in several other a 16 places. 17 MR. CAMERON: Okay. Thanks, Aubrey. We are going 18 to have that specific discussion tomorrow when we talk about 19 hours of experience and whatever for training, training and 20 experience. 21 Steve? 22 . MR. GAVITT: Just briefly, I'd like to echo what 23 Jim had mentioned previously about quality assurance and 24 equipment and what medical physicists do, and as someone 25 else had mentioned, there are a lot of standards out there (~] ANN RILEY & ASSOCIATES, LTD.
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148 1 than can be used, and I think that, if we can apply those, ( ) 2 it would be great. It's up to each facility, each 3 individual, whether or not they want to adopt those 4 standards. 5 I think, as regulators, I don't think it's up to l 6 us to go line by line and try to see if professionals are i l 7 following the standards, but I would encourage recognition ) 8 of certain organizations such as ACR or ACRO or maybe 9 possibly re-instituting the regional radiological physics 10 centers to go out and to evaluate programs, evaluate I 11 equipment, evaluate the credentials of physicists and 12 equipment, especially in, you know, radiation oncology. 13 MR. CAMERON: Can you tell us a little bit more 14 about the regional radiologic centers that you mentioned? (,,/ 15 MR. GAVITT: Well, right now, there are no 16 regional radiological physics centers. There is the 17 radiological physics center at M.D. Anderson, which goes -- 18 which facilities which participate in the RTOG protocols are 19 required to go through and have the radiological physics 20 center audit their programs, and they come into the 21 facility, they check the equipment, they check the dosimetry 22 equipment, their calculations, and the credentials of the 23 physicists in these programs, and that's something that I 24 think that we would like to see. If we could support, you 25 know, that kind of a review, then, obviously, we wouldn't (m n ANN RILEY & ASSOCIATES, LTD. \# Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
149 1 need to do that. [b 2 MR. CAMERON: Okay. I think that ties in with the 3 proposal we are going to consider in a minute, and I'm going 4 to ask Charlie Showalter to summarize that for us. 5 I guess I would want to give Don and Cathy the 6 opportunity -- is there anything in this general policy area 7 of professional standards that would be useful for specific 1 8 comment in the written comments on the rule? : 9 MS. HANEY: From the standpoint of specific ; 10 comments on the rule, yes, I think very much so, and 11 especially in the therapy area, in the 35-400 and 35-600 12 range, areas, which is the -- 400 is the brachia-therapy use 13 and the 600 is the medical device range there. 14 In that case -- again, this is -- I'll just take a (~ ( )/ 15 minute, because it will get too technical, but we relied 16 heavily on the AAPM task group reports, and there are 17 multiple reports that cover the same section areas, the same 18 thing with some of the ABS standards that are out there. 19 So, we did get some assistance from AAPM and from 20 different medical physicists in the early input stages to 21 extract from those requirements what were necessary or 77 should be included in the rule. So, you know, that would be an area where I -- you 1 24 know, I need significant comment, and I'm looking to the 25 AAPM and all -- really, the medical physicists groups to
,m
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l J 1 150 1 come in, again, especially noting the use of the gamma ()
\,3 2 knifes in particular.
3 So, I think there is a lot of feedback that we 4 will take from the community and that I hope we do get, 5 because it will help us to highlight, you know, did we pick 6 the right things, have we included things that are important 7 to safety? 8 MR. CAMERON: Okay. Thank you. I 9 Charlie Showalter is going to discuss a proposal ' 10 that was first floated at the Kansas City meeting, and we 11 also have Sandra Katanick here, who is Executive Director of 12 the Inter-Societal Accreditation Commission, who was one of 13 the groups that helped develop this particular proposal. 14 The view-graphs that you should have a copy of are (q j 15 these, the accreditation program in nuclear medicine, and 16 Charlie, I'll turn it over to you. 17 MR. SHOWALTER: Thanks, Chip, and I don't intend 18 -- I'll say at the beginning, I don't intend to go through 19 the view-graphs. The information is there, pretty much. 20 That was presented in Kansas City. 21 So, I want to stick with just the basic principles 22 and then talk about what I see as a couple or three issues 23 that, to me, are fertile ground for further discussion in 24 terms of how this might go. 25 Actually, I think I tirst brought this up in San i
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151 1 Francisco, although this idea of accreditation and 2- recognition by 101C has been floating around for many years, 3 as I understand, well before I got involved'with the NRC, 4 but it may have been that this has -- many good ideas have 5 to' wait until their time comes, and this may have been one 6 of those. 7 At San' Francisco, we got -- those of us who were
-8 interested got asked to flesh this out a little bit, and we 9 did that at a meeting at the ACR headquarters in early
~
10 September, I guess it way, and Dr. Van Heertum from the ACR
-11 and Dr.-Caretta from the SNM, ACNP made a presentation in 12- Kansas City consisting essentially of what's on these 13 view-graphs.
14 The basic idea is, if a facility voluntarily
-n
() 15 elects to become. accredited, through an accreditation 16_ program that can be recognized under whatever criteria are 17 . established by the NRC, then is there some benefit to that 18 facility in terms of NRC regulation? 19 Now, what that benefit might be is, I believe, the 20 -area _we need to discuss further, but there are a number of 21_ issues that float through here. 22- . First of all, what are the criteria for 23 -recognition of an accreditation program?
. 24 I came from the FDA and from the mammography
'25 program specifically,.where FDA does recognize accreditation
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152 1 programs in a regulatory program, but it is based on a ( ) 2 regulation, it is not based on administrative procedures. 3 So, that's certainly one approach that's viable. 4 The approach that we have discussed so far with 5 the NRC and at these meetings has been an administrative 6 approach. 7 I think that it could be done administratively. 8 There are fewer timing issues if you do it administrative 1y. 9 There is also less certainty to the regulated community as 10 to what it is that's going to come out of the possibility of 11 recognition and what assurances the community has that the 12 fly-by-night accreditation program is not going to come by 13 and suddenly become recognized because these criteria are 14 not in regulation. t
,/ 15. Now, we are certain the NRC would never do that, i 16 but we'd like to see it written down anyway.
17 So, those are, I think, the down-sides of the 18 administrative side. 19 As far as doing it by regulation, I think that, if 20 it's in regulation, there might be more of a tendency of 21 agreement states, in particular, to look favorably upon this 22 than if it is simply an administrative decision by the NRC. 23 If this approach can be worked out and can be 24 adopted, we certainly would like to see it be a uniform or l 25 relatively uniform approach nationwide and not be different i i i [ ^~-} ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 ! (202) 842-0034 { j
153
'l in agreement states and in those states that are regulated
. 2 by the NRC.
L 3 So, that's a real concern, and we're not clear on 4 exactly how that can go or should go. 5 What should the standards be for recognition of an 6 accreditation body? It strikes me that the best way to gain 7 agreement on those standards is to publish them as a j 8 proposal and get comment on them, rather than just a 9 decisionbeingmadeastowhattheyouggttobe. l 10 So, I think that's the essence of what we have on 11 the table. 12' We would like to see -- there are many reasons for 13 facilities becoming accredited by accreditation programs i 14 that are developed.by the various professional societies,
) f15 and you know, we think that, if -- there could be some 16 benefit -- further benefit from the NRC in terms of 17 regulation, because we believe the programs could meet all 18 of those regulatory criteria that the NRC is likely to set, 19 and that ought to probably be a criterion for recognition of f i
j' 20 an accreditation program, that it assures meeting all of the i i 21 appropriate or relevant NRC regulations, but you know, it l 22 would also assure a lot of other things, as'the 1 23 accreditation programs are currently constituted and was l' 24 mentioned just a minute ago. 25 That's the essence of the proposal. R 1 % ANN RILEY & ASSOCIATES, LTD.
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154 1 So, the issues as I see them -- how should
'( 2 accreditation bodies be recognized, what are the criteria, should it be administrative, should it be a regulation? If 3-4 it's a regulation, it probably requires, as some have 5~
suggested, a re-proposal of the regulations in that area, 6- and that means a time delay. So, that's a real issue, we 7 all understand that. 8' MR. CAMERON: Charlie, you mentioned the FDA. To 9 the extent that that might serve as a model here, could you 10 explain a little bit more about the FDA program, and also, 11 could you tell.us how the proposal that we have in front of 12 us now, at least from the standpoint of the medical 13 community, how that differs from the status quo, what is 14 ~ happening now-in the medical community? (). 15 In other words, is it -- the only difference with 16 this is what the NRC would have to do, or is there something 17 that the medical community would do? 18 MR. SHOWALTER: First of all, I'll address the
- 19. MQSA.
20 The FDA, as it implemented MQSA, was required by 21 the statute to recognize private, non-profit organizations 22 or state agencies as accreditation bodies. 23 First of all, FDA had to publish regulations under 24- which this recognition could be accomplished, and the way 25 the MQSA statute is structured, first a facility has to O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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' 1' become accredited by a recognized accreditation body before
() 2 they can gain an FDA certificate which allows them to 3 operate and to conduct mammography currently and, in fact, 4 ever since October of94. 5 So, it's a little different under the MQSA statute 6 in that there is an entire section in the statute on ! 7 accreditation bodies and the recognition of.them and what , 8 they have to do, and that was elaborated on, then, in the 9 implementing regulations by FDA. 10 So, that's very clearly spelled out,'and that's :
- 11. very different, of course, from the Atomic Energy Act and l 12- the' regulations that currently exist, although it is likely 1
13 that the scope of the act, while it does not specifically 14 address recognition of accreditation bodies, would not
) 15 preclude that.
16 So, I think it would be allowed under the act, and l 17 'again, in my view, best allowed by a regulatory structure. ' 1 18 Now, I think that what people would have to do -- I 19 I think the medical organizations and the accreditation 20 organizations would have to go back and take another look at 21 their accreditation program. 22 . Many of them are currently under development or in , 23 pilot testing and they have not been developed from the i 24- point of view of assuring that all NRC criteria or 25 regulations have been met. That has not been an issue up
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156 1 until this point. That would have to be done by all the ' 2 accreditation bodies that propose to be recognized by the 3 NRC.
.4 On the other hand, the NRC would have to clarify, 5 if that were to occur and if the accreditation program were
.6 to be recognized, what does that gain the facility. ]
7 So, there's an action item on both sides of the l 8 table as far as I would see it. 9 MR. CAMERON: Okay. 10 Before we go on to the other participants, do any 11 of the NRC staff have ny questions-that they want to ask
}
12 Charlie about the proposal before we go to a general j 13 discussion? I mean there may be things that' occur to you 14 later, but is there anything you want to know about this I
.{
() l15 I16 now? MS. HANEY: I think we had.a very good 17 conversation about this at the Kansas City meeting, and at l 18 -that time, we raised some concerns about the interface L 19 between the accrediting body and NRC, and I think those are ; 12 0 probably some of the key issues to working this out. 21 As to whether it would become a viable program or 22 not, I think the whole issue of, you know, looking into this ! ! 23 is very worthwhile. It would help us in the inspection 24 -area. l 25- You know, we can get into looking at, you know, I p ag_f-ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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.-e- - ~ , . . . ,.. . , . --
. . . . - . - . - . . - - - . _ . - - - . . . - - - - ~ - - - . - . - ~
1 L 157 l t based on if an organization'was accredited or not, whether
~
1-
~
~2 we're looking at facilities only doing diagnostic nuclear l
3 medicine versus therapy. It could help with the impact, the 4- . burden on11icensees. 5 So, I think it's something very worthwhile, and 1 . 6- there are some of the finer points or the next tier down l-7 that really need to be worked out about how we proceed with. 1 8 it. 9 MR. SHOWALTER: Well, we offered, I think,-in 10- Kansas City -- and I would repeat the offer here -- to 11 convene a meeting to which the entire profession and the NRC 12 would be invited to just discuss this issue, how it might 13 work'and how we~might proceed. i 14 MR.; CAMERON: Okay. Great. 15 Terry? l , 1. l 16 MR. JOHNSON: There is a parallel activity that 17' illustrat'es this accreditation point. 18 Years ago, I was a radiation safety specialist-19 'with the Ohio Department of Health, and there was another 20 agency within the Ohio Department of Health that evaluated 1 21 hospitals for Medicare and Medicaid accreditation, and I l
.22. used to get involved in those inspections sometimes because ,
23 they didn't understand the radiology departments, but these i
-24 inspections were only made at hospitals within the state i
, 25 .that were not JCHO-certified.
l ANN RILEY & ASSOCIATES, LTD. ' Court. Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ! (202) 842-0034
, ~ , - , - - - - ---. - -
l 158 1 In other words, if a hospital was JCHO-accredited, ,s/[T 2 there was no action on the part of the state agency that 3 would otherwise come out and accredit them for Medicare and 4 Medicaid payments, accepting JCHO as an alternate 5 accreditation. 6 So, in that case, it saved the licensee -- well, l 7 not licensee -- it saved the : .pitals an inspection, and if 8 that's whac's proposed for this process, this would be very 9 welcome among the hospitals and other licensees, I would 10 think. 11 MR. CAMERON: Thank you, Terry. 12 I think that prompted a question in Don's mind. 13 DR. COOL: Thank you, Chip. Actually, that 14 prompts something I'd like to some folks to address and ( ) 15 maybe in particular around here. 16 The proposal that I understand was laid out in 17 Kansas City -- and unfortunately, I had to be elsewhere and 18 I missed those discussions -- was focused with several 19 societal pieces, ACR and others, that are coming up to speed 20 right now. 21 But standing back and looking at it -- and 22 following on Terry's comment just now -- it would seem like 23 it might be a very small step from there to whether things 24 that JCHO and others may be doing -- whether there are 25 similar sorts of benefits to the process. (\m-)) ATTN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
159 1 And a second thing that I would like people to i .
'2. think about and perhaps address as we continue this
)
3 discussion -- also appreciate the offer, because I think, to ! 4 me, it requires some further refinement in a separate l 5 l discussion -- is to what extent the accreditation affects 6 specific provisions that a licensee would have to comply 7 with, that which is presently part of Part 35 and.would be 8 present versus something which might be either an entirely 9 new section or administrative procedure with regards to 10 alternative methods for demonstrating compliance during 11 license application and during inspection, which might, in 12 fact, ina somewhat separable from this particular rule track 13 and for which, depending on the outcome of these l 14 discussions, might, as a result of our discussions, () 15 . constitute a petition for rule-making which we could process 16 on its own track, which would give it its own visibility, 17 and I would like: people to give me some feedback as to
-18 whether there is such a direct linkage to specific. technical
-19_ requirements like the calibration and the other issues in 20 here that it would need to be part of this rule or whether 21 we could process it as alternative means for -- and what I
.22 think I heard was both~ possibilities, license application 23 demonstration activities and inspection demonstration 24- activities.
25 MR. CAMERON: Charlie, you may want to -- or any i ll}
\~-
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i l 160 !
'l of the others of you who were at Kansas City -- I think the i
() 2 focus was on inspection, but I'm not sure how far we went on 3 the license demonstratability issue, as you called it. l 4 Charlie, do you want to comment on that before we 5 go to the other people? I l l 6 MR. SHOWALTER: Well, I think what you've said, l ! 7 Chip, was exactly right, that's what was discussed. 8 However, in my view, I don't think the discussion should be 9 limited to that. 10 I think that it ought to be broadened to consider 11 all possibilities. They may mostly-be rejected, and we may 1 12 wind up back there, but I think it ought to be after the 13 process of consideration of. broader possibilities. 14 MR. CAMERON: And I guess that, from what I do r' \ v ,t 15 remember of that meeting, that it was thought it could be 16 limited at first to inspection and that might, indeed, allow 17 there to be a separate track from this current proposed rule 18 and that,' depending on how well it worked, it could be 19 expanded later on. 20 MR. SHOWALTER: Well, I think that's right. I 21 think the focus of that discussion, though, was that, if it 22 were limited to inspection, then it wouldn't require any
.23 separate rules, that could be handled-administrative 1y, and 24 I. guess what I'm suggesting here today is I would not like
- 25. .the possibilities limited to only that possibility. I would
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l 161 ) 1 1 like to have the possibilities expanded to a separate -- ;
'[~\ 2 perhaps, as Don mentioned, a petition for rule-making that 1
l % /-- 3 would be' handled separately-and would allow for specific l 4 recognition here. I 1 5 -- Now, that might not be a very elaborate rule. It ! 6 might be a very simple rule. I l 7 MR. CAMERON: Okay. I U 8 We're going to go to Jim Deye'and then over to Jim l
.5L l Marks, and I just would ask everybody.around the table to 1
- 11 0 think about -- are the implications of this and the elements i L
11 of this proposal -- is.this clear to you? In other words,- r I 12 do we need.to put some further explanation on what's going-13 on here? 14 Jim? ! 15 MR. DEYE: Yes. In fact, that's one of my' 16 concerns. I have a number of questions. 1 l 1 17 I worked closely with ACR and the FDA when MQSA 18 was being developed. I think'I understand that program, but 19 I'm'having a real reach trying to see how that would work 20 into the NRC's concerns and mandate. l
)
21 For example, one has to consider.that even MQSA, 22- now that it's fully implemented, there are a number of 12 3 criticism of it-that it has led to a lot of additional
, -24 expense to individual ~ mammography facilities.
25' It is now being questioned whether that, in fact, 1 I , f '/) ANN RILEY & ASSOCIATES, LTD. ' %- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 162 1 1 has.added, really, to the quality of mammography in the () 2 United' States over and above what was being achieved through 3 voluntary methods that the ACR and.public pressure was 4 bringing to bear,-as opposed to a regulatory requirement, 5 'and it did, in fact, lead, in many cases, to dual 6 regulation, which is exactly one of Dr. Marcus' most salient
- 7. points.
8 You now have each mammography tube'in our state, 9 at least, in Virginia, having to undergo the inspection 10 ~ required of MQSA in addition to that that is mandated by the
- 11. -State of Virginia.
12 Now, we, for efficiency purposes, try to combine
.13 those two visits if at all possible, but that's not always 14 the case.
15- So,'I am very confused as to how this would work. 16 and what benefit an institution would get. 17c I am all in favor of accreditation. Our radiation 18 oncology-facility is accredited voluntarily under the ACR 19 program, and I think that's a very valuable program.
.20 I would like to see it recognized some way in the 21 NRC regulations, but if I'm hearing this correctly and 22- somehow it is going to largely supplant the radiation safety 23 concerns of the NRC, I don't see how that=is going to
- 24. happen.
~25
. And JCHO keeps getting mentioned. Maybe I'm naive
/~%
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163 1 and not informed on JCHO to where I should be, but my ]} 2 reading of JCHO and our visits with them lately indicates 3 that they're moving away from these kind of prescriptive, 4 detailed requirements on the institution. 5 They've moved away from board -- discussion of 6 board certification, of directors of radiation oncology, our 7 chairmen, chairwomen, whatever. They have moved away from 8 very specific statements about the medical physicist role 9 within the programs within radiation oncology, nuke med, 10 radiology. 11 So, I am nbt looking personally to JCHO to help 12 with your mandate on the NRC radiation safety side. 13 So, those are just some comments. 14 MR. CAMERON: Charlie, you know, for better or for
) 15 worse, I think you're the point person here, and I thought 16 that I understood Jim's remarks about creating a second --
17 another layer of regulation here, out I thought that the 18 idea behind this was that, if it was accredited through 19 whatever organization that we're talking about, that, for 20 example, the NRC might be able to focus its inspection 21 resources better by not going out on its normal inspection 22 frequency to that particular facility. 23 MR. SHOWALTER: One of the fundamental differences 24 in what we have suggested here and MQSA is that MQSA is 25 mandatory and we're suggesting that this ought to be I) ANN RILEY & ASSOCIATES, LTD. \l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 o
164 1 . voluntary, that no facility would be required to go through ( 2 accreditation, however if they elected to go through 3 accreditation, there might some benefit to them in terms of 4 inspectional frequency or something like that, matters to be 5 discussed, yes, that's right. 6 MR. CAMERON: So, in other words, the facility 7 might not have to go through -- let's call it your 8 accreditation program, but one of the incentives might be 9 that, to the extent that your accreditation program 10 satisfied NRC criteria, that there would be some regulatory 11 compliance benefit to the facility. 12 MR. SHOWALTER: Indeed, in addition to, as Jim 13 says, you know, it being, just in principle, a very good 14 idea, we think, for facilities to subject themselves to this 15 process. 16 Now, I think, in the oncology area, this is a. 17 ~ possibility, but that's not what we're really talking about 18 right now. 19 What we're really talking about is diagnostic 20 nuclear medicine right now. I'think it could be expanded to 7 21 other areas, and perhaps I didn't say that in the beginning, 22 and I should have, but that is the essence of what we're 23 proposing right now, is to start in the diagnostic area. 24 MR. CAMERON: Okay. And I take it that there's a 25 number of organizations that are presently accredited in the O ANN RILEY & ASSOCIATES, LTD.
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165 1; diagnostic area now.- () 2 MR. SHOWALTER: Well, not by us yet. Our program, 3 right now, is undergoing pilot testing. We expect it to be 4 , viable early next year. So, you know, it's sort in phase j 5 with the-timing of this regulation. 6- It's one of a number of accreditation programs 7 that have been developed by the college. We think we know 8 how to do it now. We don't expect there to be any problem 9 going' live early next year, but right now, it's isn't. 10 MR. CAMERON: Okay. 11 Let's go to Carol and then over to Jim Marks. 12 DR. MARCUS: First of all, the American College'of 13 Nuclear Physicians has had a practice audit program for 14 years which people voluntarily subscribe to. So, there is () 15' in existence a nuclear medicine accreditation program that 16 works very well. 17 However, the criteria are those of the 18 professionals in nuclear medicine, not the NRC, and the 19 ACNP, I would sincerely doubt is going to let the NRC tell 20' it what it should look for. 21 The whole purpose is getting a professional 22 quality assurance program is that the professionals can do a 23' much job of it. 24 The whole reason for even talking about this now 25' is that we're very. dissatisfied with the proposed Part 35 I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,- D.C. 20036 (202) 842-0034
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l 166 j i l 1 and want a substitute for it, not have ACNP practice audit I l I' l /"'\ 2 inspectors substitute for NRC inspectors using your ! V 3 criteria. 4 It's really deja vu all over again. Ten years 5 ago, we did the exact'same thing when we were talking about 6 the QM rule, and the NRC wanted a report of all the { 7 violations so that they could give fines to people and l l 8 wanted JCAHO and ACNP practice audit to rat on people so l l 9 they could get violations, and of course, the whole thing 10 fell apart, because we had no intention of behaving in that l i 11 manner. 12 I wonder if this isn't just a diversionary tactic 13 right now. It wasn't in the regulation. NRC wasted a lot 14 of our time with this 10 years ago. , :( 15 I think it's a very good idea a substitute, 16 outright substitute for Part 35 and NRC inspections, but if 17 NRC isn't prepared to see it as a substitute, then all it is
.18 ' is a lot of extra work and we.better get back to what NRC 19 has cn1 the table for us, which are a set of proposed
-20 regulations with.a lot of problems.
.21 So, I'd like -- since I wasn't in Kansas City, I'd L
t R22 .like to know what your. intentions are, Mr. Thompson. What 23 is going on here? 24 MR. THOMPSON: My intention is to let Cathy answer 25 .the question. ANN RILEY & ASSOCIATES, LTD. ()\
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167 1 MS. HANEY: Carol, I think how this got started () 2- was, in San Francisco, a similar discussion on use of 3 industry standards, we were talking about how they could use 4 them, and I believe - and I guess Dave and Charlie can 5 correct-me if I'm wrong -- is that the professional 6 societies brought to our attention the possibility of using 7 accreditation as a means -- how can this help, how can this 8- play, could we use it in the inspection ares? 9 What we did coming out of that meeting was say 10 that's a very good idea,~why don't you come back -- you 11- know, if you think it's worthwhile and you would want to 12 propose it, then do that.
-13 So, it was more the professional societies i
14' bringing to our attention the accreditation program and how
/~)
(,,/ 15- it could be used, and again, if I'm misstating that, 16- Charlie, you can correct me, but I think it was -- that was 17 more what brought it on the table ant' brought it into 18 discussion. 19 DR. MARCUS: Okay. Then answer my question. Are 20 you prepared to seriously consider accreditation by a 21 professional QA program as a substitute for the prescriptive 22 parts of Part 35 and an NRC inspeccion or not? Because if 23' the answer is no, I really suggest that it's almost 24 irrelevant to what's on the table here, because -- 25 -MR. THOMPSON: I think that's a policy issue that ANN RILEY & ASSOCIATES, LTD.
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1 right now has not really been presented to the Commission'.
-[ 2 DR. MARCUS: Okay.
3 MR. THOMPSON: And we really would not be able to l 4 do -- we can present items and ideas to the Commission. 5 They have accepted accreditation programs for i 6 other areas as in lieu of NRC regulation, like an INPO ! 7 accreditation of the training programs. They have accepted 8 that. 9 They've accepted it for radiographers, the 10 accreditation program. 11 So, it's not that we won't. It just hasn't, I 12 think, matured in its way to -- that it would make it 13 immediately -- I could say the Commission has looked'very 14 hard at the area of nuclear medicine, and this has not been ( 15- .a direction they've given us. i6 Nevertheless, I don't think it's -- I agree with 17 you, I think we do need to get on and look -- with the 18 regulation that we've got. 19 I mean there are issues here that we need to 20 -address and to make sure we understand the concerns, 21 understand the options of fixing them. 22 . But I don't think we would automatically not take 23 advantage of -- if there is an opportunity to have an 24 accreditation program that would either be a substitute for 25 our own inspection program or even potentially a substitute O ANN RILEY & ASSOCIATES, LTD.
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169 1 for -- you have to look at it like a general license. ('N d 2 That is, if you have a accredited program, I don't 3 think that we would rule out that we would not be able to 4 say that, if you have an accredited program and you do 5 diagnostic -- I'm going to call it low-risk type of activity 6 -- you'might be able to say you have a general license. 7 MR. CAMERON: Okay, Ken. 8 And Carol, this did sincerely grow out of an 9' effort by the NRC staff to at least try to encourage a , 10 suggestion from the medical community that would give life 11 .:o that statement in the medical policy, that phrase in a < 12 medical policy statement to give deference to a set of ' 13 professional standards. > 14 So, I think that the intent is good, and as you () 15 point out, there's a lot of things that may need to be
~
I 16 discussed with it, but I think that's what the intent is, is l 17 to.have that discussion. L 18 Jim Marks, t 19 DR. MARKS: I don't think anyone's against -- 20 necessarily against the NRC from regulating. That's your 21 job. I think what we would like to see is an effective l 22 collaboration with the physician community. L 23 In the case of ACGME, with whom I've worked for a 24 long time, there was a peer review process, and the 25 physicians were intimately involved in regulating the l O ANN RILEY & ASSOCIATES, LTD. (_ l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
170 1 educational activities of the institutions involved in '
/ 2 training people in our specialty, and it was, I thought, a ,
3 very effective interaction. 4 So, I'm very interesting in this proposal that you 5 put forth, but I'm not sure I understand it, so you'll 6 forgive me if I'm a bit mechanistic. So, I'll describe what ; 7 I think I heard, and you tell me if this is the way it would ! 8 work. 1 9 The NRC would make regulations that would ) 10 determine the number of didactic hours, radiation safety 11 lecture, physics lectures. They would determine how much 12 clir.ical experience in the use of radio-iodine, how much
.13 clinical experience in the use of a remote af ter-loader, a I
1 14' cobalt-60 source machine, etcetera, and then make sure that () 15 all of those stipulations were in the standards of 16 accreditation by the ACGME, but the actual inspection of the 17 educational facility being accredited would be done by 18 ACGME, and then the report available to NRC and NRC l 19 recognizes that accrediting body and the results of their 20 inspection. 1 21 MR. SHOWALTER: Well, sort of in general, yes, but 22 I.think there are a lot of details -- that is, I'm not sure 23 that the accreditation bodies are going to be real happy ,
- 24 about reporting all of the violations to the NRC, for '
25 example. ANN RILEY & ASSOCIATES, LTD. 1
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1 V 171 1 I'm not sure NRC is going to be very happy not ( h 2 getting those, and so, there's a lot of issues and a lot of V ! 3 things to work out, but part of the problem is that we don't 4 have all of the details. 5 Right now, it's an idea. We don't know how it 6 might work. There seems to be receptivity on both sides 7 that there are possibilities for working out the details to 8 everyone's satisfaction. I think that's what we would like l 9 to try to do. I'm not suggesting we have all of them at 10 this point. 11 MR. CAMERON: Okay. 1 12 Let's go to Mickey, Mary, and then Shelby. 13 MS. CLARKE: One of the things that I think we 14 need to think about up front, before this goes a whole lot [T ( j .15 . farther and we waste a lot of energy on it, is, as each 16 regulator looks at each other around the table, the state, 17 JCHO, the voluntary accreditation organizations, none of 18 this is happening for free. Who's going to back off on the
'19 fec:/ Because otherwise, this becomes yet another expense 20 charged to the practitioner, and it onl/ escalates the cost, 21 when this morning we had a long discussion about lowering 22 costs. .
1
~23 MR. CAMERON: Okay. Another issue to consider.
24' Mary. 25 MS. FOX: Well, that was my thought, too. i l l r l /\ ANN RILEY & ASSOCIATES, LTD. k-- Court Reporters 1025 Connecticut Avenue, NW, Guite 1014 Washington, D.C. 20036 (202) 842-0034
172 1 Also, I see it being confusing for not only myself 3
- . r%
}} 2 as'to who I answer to on what day but who the hospital 3 answers to, and I think, so far, the NRC and the Joint 4 Commission have worked pretty well together.
5 Whenever the Joint Commission comes to my
- 6 institution,-they pretty much stay away from any of the nuke .
7 stuff, because they know the NRC has already covered it 8 pretty extensively. !
- 9 I see this turning into big business, actually.
[ '10 I missed who you were with. ; . 11 MR. SHOWALTER) The American College of j i 12 Radiologists.
.13 . MS. FOX: You are with the ACR.
And then I wondered -- so, we pay for an NRC
-]
( ,e 15 license, and then,-nuclear medicine people can come in.and l
.16 inspection nuclear medicine, then I have Joint Commission i 17 give all these different -- do I get inspected 10 times a 18 year, then, or 10 times every five years?
.19 MR. SHOWALTER: Well, I think, ideally, there 20' would be some reciprocal kinds of arrangements worked out 21 here. That would be the point of the whole thing. If that )
122 isn't the case, then it's probably not going to work. And I 23 guess, though, the other point about that is that we and, I 24 think, the other professional organizations believe that l25 there are. lots of benefits to accreditation programs without [l
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173 1 even bringing the NRC into the picture. 2. ( )~ Now, if there is an additional benefit that can be 3 derived from the NRC, then that makes the accreditation 4 program even more attractive. That's the' approach we're 5 going into it with. Whether that's workable or not, we'll 1 1
-6 'see.
i 7 MR. CAMERON: Okay. l 8 Shelby, then Roy. 9 MS. DUNSTER: Well, I'm listening to all of this, ! i 10 sort of trying to visualize how this plays out. 11 I would say, in response to an earlier comment, 12 that there is no question that the Joint Commission i 13 standards have become less prescriptive over the years, and 14 where, previously, we had a manual structured that had l I ( s-
) 15 chapters specifically on nuclear medicine, radiology l 1
16 oncology, and diagnostic radiology, we're dropped that 17 approach to accreditation. ; 18 One thing to just sort of bear in mind or muddy , i 19 the waters with in all of this is that the Joint Commission 20 has also begun to undertake activity to recognize other l 21 accrediting bodies, to try to work in collaboration with 22 them, with the goal of reducing duplication and then, to the
'23 extent possible, the cost to the organization that's born.
24 To date, we have a collaborative agreement with 25 the Council on the Accreditation of Rehabilitation
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174 1 Facilities, and then there are a host of other accrediting ' }r' .2 bodies that we are in the process of working with, and to be N-3 frank with you right now, I don't know what the outcome of , 4 those sorts of recognition agreements have been, but it's l 5 .just something to bear in mind. 6 MR. SHOWALTER: Indeed, I understand that our 7 radiation oncology accreditation program was recently 8 recognized by JCHO, and you know, ultimately, it would be 9 nice if the same thing could happen, after it matures, in l l 10 the diagnostic area. ' 11 MR. CAMERON: Okay. 1 12 Roy. l 13 MR. BROWN: I just want to make sure everybody 14 realizes this is something that the industry is pushing. .
.(
)- 15 This is not an NRC idea.
i: l'6 As Cathy and Chip said, this came up in San 17 Francisco. Cathy and Chip said go take a'look at it and 18 come back with a recommendation. So, the ACR met with SNP l l 19 and ACNP, and they put together the proposal that was 20 presented in Kansas City. 21 So, this is an industry initiative, and the 22 purpose is, anyone that would participate in this voluntary 23 accreditation would be exempt or would not have to undergo 24 NRC inspection. That was the whole purpose of it, and j
,- 25 that's the potential benefit.
t l t s'% ANN RILEY & ASSOCIATES, LTD. 1,,) Court Reporters 1 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 t (202) 842-0034 L l
175 1 Talking to Felix Killar of NEI, it sounds like t
/~h 2 INPO, the Institute of Nuclear Power Operations, has a 3 similar accreditation program for parts of the nuclear power 4 industry', and it sounds like that works very, very 5 effectively.
6 So, maybe that's a model we need to look at and 7 try to make this accreditation program somewhat similar and 8 maybe compare it to the INPO program, because that seems to 9 work very well. 10 MR. CAMERON: Okay. Thanks for that 11 clarification, Roy, and I guess a further point on that, for 12 you and Don and Cathy, I think that the assumption of the 13 NRC at this point is that we would be fully willing to help 14 and talk on this effort, but as you pointed out, sort of the 15 ball is in the industry, the community's court at this
}
16 point. P 17 It's not something that we're pushing to try to 18 divert people's attention from Part 35, although that might i 19 be a welcome diversion at this point, but at any rate -- l 20 MR. BROWN: One more point -- I'm sorry -- I 21 didn't make. 22 , I would also like to see this developed 23- concurrently with Part 35. I would not like to see Part 35 24 be finalized and this be done under a separate rule. I 25 would really like to see them on parallel tracks, for ANN RILEY & ASSOCIATES, LTD. O~ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
176 1 -obvious reasons.
- ['\ 2 MR. THOMPSON: You might remember that the INPO 3 accreditation program was a major effort to put in place, 1
4 and it was well established before NRC adopted it by 5 rule-making, and we did adopt it by rule-making. 6 MR. CAMERON: Okay. Thanks, Hugh, for that 7 clarification. ' 8 DR. NAG: I think what we might want to think 1 l 9 about is,.rather than having an adversarial role, how we can 10 have a collaborative role, and rather than you making the 11 rules and, you know, we following it, we help you make the 1 12 rules, and I would like to ask the other body, ACR or the l I 13 Nuclear Medicine Society, to all put in our thoughts and ! 14 help you and be part of your working group, not just give () 15
- 16 you something in writing and you do what you want with it, no.
17 We want to be part of that working group. We 1 18 wanted to develop your recommendation with you. That's, I i 19 think, what we should be doing. ) 20 MR. CAMERON: Thanks, Subir, and that's a comment 21 that Carol made earlier, and I think it's a general issue 22 around the table, not only for this rule but for further 23 manifestations on these issues, is how can the NRC and the 2
.4 medical community work more effectively within, you know, 25 the legal framework that we have to operate under?
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177 1 Bill, you've had your card up for a while, and ( ) 2 then we'll take Jim Fletcher and then Terry, and I think we 3 probably have beaten this for a-while. ! l 4 DR. VAN DECKER: I just wanted to say, from the I 5 American Society of Nuclear Cardiology's standpoint, we also i l 6 find professional laboratory accreditation a useful concept ; 7 for raising professional standards on a CME basis across the 8 board anyway and on an internal realization of continuous 9 quality improvement, and some work was started on this 10 already in this regard, and obviously, we would be 1 11 interested in exploring some of this with some of the other l 12 people that are interested in it, for all the very reasons 13 that everyone has brought out, and I think that the only 14 real issues here are obvious, one, to make sure that things
) .15 are as inclusionary as possible, or that, if that's not the j
l
. 6-1 case, then'there are at least multiple options to do ' . 17 something.
i 18 I'm sure the endocrinologists probably also have 19 interests in this realm, also, and so, I think that there's 20 something here that can be worked with. l 21 MR. CAMERON: Okay. Thanks, Bill. That was very 1 22 positive. l 23 Terry and then over to Dr. Fletcher. 24 MR. JOHNSON: Oh, you wanted to call him first. 25 MR. CAMERON: Go ahead, Dr. Fletcher. l.
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- , _ _ _ .. . . _ _ _ _ - _ . . _ _ . . . _ _ __ - ~ _ _ _. _ _ _ ._ __ . . _ _ _ _ _ _ . _ . _ _ . 178 1 DR. FLETCHER: Just a brief comment. I want to [
- 2 beat on what .Subir just said, and I think it's important to 3 realize that inherent in the success of programs like the r
4 ACGME for graduate medical education in this country and the 5 Joint Commission and the reason those programs work is 6 because of the collaboration and the people, the r 7 professionals are sitting at the table really having 8 considerable input to the guidelines, to the standards that 9 are ultimately used to determine accreditation, and that -- 10 whether it's for a training. program or whether it be for an 11 institution, and so, I don't see that this pilot would be 12 very successful unless that collaborative scheme could be 13 brought to the table and worked out. 14 MR. CAMERON: Okay. Thank you. And I don't think r% 15 i ( J' that anybody disagrees with that. 16 Terry? 17 MR. JOHNSON: Well, in looking around for 18 accrediting bodies that would most likely suit the purposes L p 19 of the NRC, particularly if the NRC is going to respond to l l20 the comments all around the table to move more strictly into 21 occupational safety and away from the practice of medicine, 22 it would seem to me that the American Board of Health l i 23 Physics would be ideally suited to execute that type of 24 accreditation program, because it's a group of professionals L. 25 whose sole interest is occupational safety, and also l~ F ANN RILEY & ASSOCIATES, LTD. i' k. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 r
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I 179 1 radiation safety in the environment and among the general 2 .public, but not addressing such issues as written 3 directives, 4 So, this would be something you might want to 1 l 5 consider for a collaborative effort, 6 MR. CAMERON: All right. And we will have some 7 representatives, I guess, tomorrow from that particular 8 board. 9 Jo you have anything you wanted to say on that. 10 Cathy? 11 Okay. 12 I think what we'll do is we will hear David, and 13 maybe we'll take a short break before we go into the 14 inspection module. () 15 16
. David?
DR. KRAUSE: Well, this may be stepping a little 17 bit'into tomorrow, but I think that it should be -- when you L 18 think of who is going to be your collaborator, you have to l i 19 realize that only radiation oncology and radiation -- and j 1
'20 diagnostic radiology and nuclear medicine are the only ones
~21 that have in their ACGME requirements an actual formal 22 training program that consists of radiation physics, 1
l 23 radiation safety, and that if you sort of open it up to L 24: various other specialties who form their own little
'25 accreditation committee, their own training programs do not /"' ANN RILEY & ASSOCIATES, LTD.
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180 1 incorporate anything near, if at all, what is a present (}I a 2 requirement,.and so, I think somebody mentioned just opening 3 it up if some sort of accreditation body comes along. t 4 So, I think the NRC needs to be very careful that, 5 whoever their collaborators'are, if they choose to go that 6 route, has a very strict program that basically holds to the 7 couple hundred hours of didactic, holds to the 500 hours of 8 experience -- we would prefer it to be three years, but -- 9 well, you know, it's basically -- we'll get into this issue ) l 10 tomorrow, but there are some real issues about experience 11 _that you can't learn in two, three weeks in the classroom, 12 and I think that you've got to be very careful who your ) 13 collaborators are. 14 MR. CAMERON: Hugh, did you want to say something? l l q() 15 MR. THOMPSON: No. 116 MR. CAMERON: We'll come back up if we need to. 17 Sandra? 18 MS. ROTHSCHILD: I represent the Inter-Societal 19 Commission for the Accreditation of Nuclear Medicine 20 Laboratories, and we do -- we are very similarly structured 21 as is the ACR, as is ANCP. i L 22 , The difference with our organization is, however, i 23 that we have six sponsoring professional societies who have 24 come together to write professional standards for -- first l l 25 starting with nuclear cardiology testing and now under ! 4 i i /~ \ ANN RILEY & ASSOCIATES, LTD.
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181 1 development for general nuclear medicine testing. l [v )/ 2 So, it is all for the diagnostic nucrear medicine 3 aspect of this. ) i 4 To reiterate some of what Charlie has said, our )1 5 program, sa well as the ACR, does provide a peer review l 6 evaluation, and I think that is the one thing that the NRC 7 does lack, from what I'm hearing, is the peer review aspect l 8 of your inspection. I 9 We then determine whether there is compliance to 10 published guidelines. I 11 We then provide the laboratory with a detailed 12 analysis of what they're doing rignt as well as what they're l 13 doing wrong and give them a chance to correct it. 14 Some of the things that we do not have in process,
<~s I
( ,) 15 as well as I believe ACR does not have in process either, is i i 16 that we had not intended this process to be an on-site -- or l l 17 to provide an on-site evaluation of every laboratory. ) 18 We also have experience through an inter-societal 19 approach with accrediting other diagnostic modalities so 20 that we know that a paper process does work, that it doesn't ! 21 necessarily need an on-site evaluation. l 22 . We did not design it to be used in lieu of an NRC l 23 inspection. However, I believe that our standards are not 24 static, so that they can be changed to incorporate some of 25 those aspects. [ \ ANN RILEY & ASSOCIATES, LTD. Y- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
182 1 The cost to date has always been absorbed by the () 2 laboratory, but it's always been set up such that it covers 3 our cost, and we are.a non-profit organization, as well as 4 the other accrediting bodies. 5 We do have the input from ACNP, from the American 6 College of Nuclear Physicians, using some of the tenets of 7 .their program. However, again, I'd like to emphasize that 8 we do not intend to inspect every program.
- 9. MR. CAMERON: Okay. Thanks for that description 10 and for the emphasis on the peer review. I think that, in 11 terms of what was said at the Kansas City meeting, that the 12 . aspect of the peer review might provide a little bit more 13- friendlier, user-friendly, understanding atmosphere for this 14 to happen in, as opposed.to, perhaps, the NRC inspection 15 framework.
- 16. Other comments out here, not only on this
-17 .particular proposal but on the whole issue of voluntary 18 standards generally?
19 Suntha? 20 MR. SUNTHARALINGAM: I am a former professor of 21 medical physics at Thomas Jefferson University, having had
~22 - leadership roles at AAPM, American College of Medical 2
.3 Physics, 24 Some of the comments that I heard, one needs to 25: probably separate out what are credentialing application ANN RILEY & ASSOCIATES, LTD.
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l 183 ; l , 1 programs to accommodate physician qualifications from
\_)\ 2 programs that are required accrediting the whole program, as 3 such, with an emphasis on radiation safety, because most of 4 the audit programs that are currently in place are, I think, '
5 looking at more the practice of medicine and the standards 6 of practice of medicine and delivering appropriate care to 7 the patient. 8 What has been lacking in the existing programs is 9 sort of an audit of the entire program. 10 It was mentioned by Jim Deye that physicists are i 11 involved with calibration of equipment. That's one part of 12 it, but there is a lot that goes on in the radiation safety 13 program, and unfortunately in this country, we do not have
,, -~g 14 adequate training programs for training of medical
\ l
15 physicists and hospital health physicists.
16 Training of physicians, yes. The graduate medical 17 education program, adequately funded, I believe, through the ; l 18 Health Care Finance Agency supplements, those training 19 programs exist, but training programs for practicing medical 20 physicists and hospital health physicists do not exist in 21 the numbers requirsd. l 22 . So, people take individuals and just give them l 23 on-the-job training. That's why we have board certification l 24 programs. That is to certify practicing medical physicists 25 and practicing, now, medical health physicists. A
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184 ,,s 1 The program in medical health physics was started \ -] 2 a few years ago, again primarily because the American Board 3 of Health Physics was dropping the section on medical health 4 physics with emphasis just on nuclear reactor physics. 5 The American Academy of Health Physics, ACHP, is a 6 much' larger organization, including all health physicists, 7 came to the American Board of Medical Physics and wanted to 8 be a sponsoring organization, and now we have just embarked 9 on a certification program for hospital-based health 10 physicists, and to me, what is, I think, lacking in the 11 discussion so far is how do you alternately try to 12 credential a radiation safety program in the delivery of 13 medical care? (~s 14 That's a whole separate section as compared to \~)g 15 looking at what the physicians can or cannot do. - l 16 Every application requires a medical physicists, 17 irrespective of the area in which we are dealing with, and 18 medical physicists are also going to be responsible for 19 radiation safety. I 20 Everything that we have been talking about cannot l 21 be practiced without the help of a medical physicist. 22 There's a shortage of good medical physicists, a shortage of 23 good medical health physicists. 24 I mean if there are 1,900 facilities doing 25 radiation oncology in thic country, a fair number are using ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
4 da ,& .A .4 5 4,+ 4 -4,e >h a 44-= M* b 185
-) 1 consulting physicists-once in.a while, and the question is ;
2 _ will=they still be able to meet the standards required to 3' maintain the same radiation safety program? , 4 MR. CAMERON: Okay. Thank you very much, Suntha. ' L 5 Felix?- i 6- MR. KILLAR: I just wanted to reiterate the point 4 7 earlier'that Roy had mentioned, as well as Mr. Thompson. EL In the nuclear industry, in the utility industry, 9- in particular, the industry went out and they established a 10' number of their own requirements in order to meet the needs
~11 of the NRC.
12 Once they established those requirements, they 1 13 went to the NRC and got them recognized by the NRC as an 14 acceptable practice from the industry, and therefore, the 15 NRC did not have to regulate. 1 16 I think the accreditation program could be 17 something'very similar in: nature in that the professional 18- . societies would be able to design the programs to meet the 19 needs, and it will'be based on the professional society's 20 programs, but at the same time they'll address the NRC 21 needs, as well'. 22' . This is a way of meeting the intent of the NRC 23- regulation, but you are regulating, to an extent, on your 24 own. 25 So, I think it's something that certainly should I j j 1 N- ANN RILEY & ASSOCIATES, LTD. Court Reporters )' 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
186
,_ 1 be pursued, and certainly, there is a record with the NRC of \- / 2 acceptance of these programs. 1 1
3 It can be certainly on a voluntary basis, as well. I l 4 A number of the programs, particularly for the utility 1 5 industry, are reflected in the reg guides, and they say, if { 6 you follow this program in lieu of the NRC's regulation over l l 7 here, that is considered acceptable. l t 8 So, you have a choice. You can go through and ' 9 design your own individual program to meet the NRC 10 regulations, or you can join this voluntary program over i 11 here that the industry put up and use that as a way of 12 meeting the needs of the NRC. 13 So, it gives you the voluntary aspect of it, but gs
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14 it also gives you recognition from the NRC, and it's (
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15 something that you guys need to consider. 16 MR. CAMERON: Okay. Thanks, Felix. 17 How about this gentleman in the back? 18 MR. MECKELNBURC: Bob Meckelnburc, president of 19 the American College of Nuclear Physicians, and for those of 20 you that attended the Kansas City meeting, I apologize, but 21 let me bring you up to date on what the American College has 22 been doing for well over the past decade. 23 It's had two programs of accreditation for 24 laboratories, basically an on-site inspection, which 25 obvious 1" makes certain that the laboratory does meet all , f%. ; (__/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 I Washington, D.C. 20036 l- (202) 842-0034
187 1 the Juu: requirements but goes beyond that into the clinical
) 2 practice of medicine.
3 I would tell you that this program is very well 4- received. We hardly ever hear any complaints about this, t-5 and most of the people feel very satisfied, even though this 6' 'is an extra expense to them and there is no play-off in any 7 Other way, shape, or form. 8 The other program we carry out is our proficiency 9 testing program, where we send out phantoms to the 10 = laboratories that sign on for this program twice a year. 11 We are up to our 31st phantom coming this spring-. E12 So, the program has been operating very well and is, again, I i 13 very well-received.
,_ 14 Both of these programs are geared to what the N- -
15 peers in the field feel is necessary for adequate competency 16 for practice, and I think that it's my endeavor to make sure j 17 that both of these programs continue, with or without help, 18 but I would say this, that we've had a lot of help of 19 industry in the past, and we think that these programs are E 20 vital to our existence, and we're going to do everything we 21 can to make sure that they continue. 22 , MR. CAMERON: Great. Thanks, Bob. [ 23 I don't know why the phrase " phantom regulator" 24 keeps running through my mind at this point. I didn't hear L 25 that term before. But thank you. i
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l l 1 188 1 How about anybody else out in the audience on
..0 l \_/ 2 either the specific proposal or the professional standards?
L 3 Mary. 4 MS. FOX: I think we've opened up a whole can of 5 worms here. Everybody's vying to be an accreditating body, 6 and I think we've spent enough time on this. I'd like to 7 see us get back to the meat of why we're here. We only have 8 a day-and-a-quarter left. 9 We've-got three or four endocrinologists over 10 there. We could probably knock off their concerns quickly. I 11 We have the cardiologists. ! 12 Everybody here wants to see the retention of the 13 radiation safety committee and other issues, and I would y- 14 (g ) 15 just like to get back to the purpose that we're here. MR. CAMERON: I thought if you just continued to 16 knock them off, we could adjourn. 17 No, we're going to, but I think it was important 18 -- or we believed it was important, at least, to recognize, 19 you know, initiatives that the industry wanted to make. 20- We are going to go into another -- I feel like I 21 should say I have to warn you, we are going to go into 22 another over-arching issue after the break, which is the 23 inspection issue, which I think people are going to be 24 interested in, because I think that there is some concern 25 about the issue that's been framed as how you inspect l
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i 1 i 189 q f '1 1against'a performance-based rule or what you give us in-l 2~ terms of broader-based-regulation'is all going to be taken 13 away because there is going to be detailed so-called
)
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4 guidance or inspection procedures. ' 5 That's coming up next, and let's take a break for L '6 15 minutes and come back. 7 [ Recess.)
- 8 MR. CAMERON
- We're going to get started again, if 9f we could get you back up to the table.
l '10 Are-there any stragglers out there that we need to 11 get'back to the table? I know we have some stragglers out [ 12 there in the lobby. 13 But Cathy, are you going to --
)
l ['T
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14' I'm going to ask Cathy to perhaps -- ! i 11 5 ' MS. HANEY: I would like to do it on the record. I l-11 6 MR. CAMERON: -- tee up --
- 17' MS. HANEY
- Of course, I'd be pleased to.
18 MR. CAMERON: -- the inspection issue for us, and p 19 I know that there is concern over this particular issue, and i 20 -Hugh Thompson wants to say something here, and I want to 21' ' introduce someone in a minute, after you're done. 22' , Go ahead. , 23 MR. THOMPSON: Okay. l L 24 .I don't-know how many people are going to be here I- 25 tomorrow. I may not be able to be here, but one of the ANN RILEY & ASSOCIATES, LTD. Court Reporters l .1025 Connecticut Avenue, NW, Suite 1014 l- Washington, D.C. 20036 (202) 842-0034
, n.,-.--. -. .- .-....-.n.. - - - - - - - . - . - . - . . - - . 190 1 themes that really came through fairly loud and clear to me, ! 2 and1obviously, I've got to go back up to the Commission and 3' give them a kind of a quick snapshot of what this meeting
~4 has produced, and one of them, I think, is a -- and I'd like 5 to get1a sense right now, maybe the people in the 6 auditorium, of a extension of the comment period. >
7 I don't think that there is.any -- I haven't heard L8 anyone say otherwise,-but I'd like to make sure I have a i l 9 consensus of the assembled body here,-and I guess it kind of 10' goes a little bit to me'that -- I think it's kind of two 11l elements, that the current Part 35 is not creating such a 12 problem that we need to rush to get the -- a revision in.
'13 I know that's kind of hard for some of you to
-14 swallow, and I'm probabl'y looking at Carol.
15 I want to get my glasses on so I can makeisure 16 Carol.is supporting me in this, but I'd like to be able to 17 be clear, if I.go back to the Commission, that everyone, in 18 essence, here - I don't.want to say it's unanimous, but I'd 19 like to say it's unanimous. 20 If anybody has a different view, please say so, 21- but'I think it's pretty much unanimous here'that everyone 22 believes that the comment period should be extended. I 23 ' don't know whether we are talking 90 days er 180 days, but 24 certainly sufficient to allow a detailed review of the 25 document that comes out. O ANN RILEY &' ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034 1
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191 7 .s 1 DR. NAG: It may be the only thing where you will e \
/ 2 get an unanimous opinion.
3 MR. THOMPSON: Well, that's why I'd love on 4 unanimous opinion, and I certainly would -- I guess the 5 other one I think that I'll need to -- I'd like to go back 6 with -- and so, I'm going to leave this with Cathy -- is 7 some description on this risk assessment issue. 8 Risk assessment is really, really not 9 well-developed in this area. We've tried to develop it for 10 a long time, and I know you have made a real point about 11 need for risk assessment. We kind of do a qualitative, we 12 kind of do diagnostic versus therapeutic, and we have 13 certain ways to do that. r)
~
14 I think it's going to be real valuable for us to 15 be able to communicate if what we're looking for is this 16 risk assessment to be done in this period. If that is the 17 intent, I need to understand how long it would take to do 18 such a risk assessment, other than Carol Marcus. 19 DR. MARCUS: Well, are you talking about the staff 20 doing a risk assessment or contracting it out? 21 MR. THOMPSON: Well, first off, I don't know 22 exactly -- when we ta]k about doing risk assessment, I 23 talked to Carl Paperiello about it, and he talks about 24 almost taking a year or so to do it. I mean it's not an 25 easy thing to do, to do it in its detailed process that you g}
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,_ .1 go through. I
(- / 2 Now, you were doing them in a few minutes. I. 3- don't know'whether we could probably get you to be part of 4 the year job or the few-minute job. 5 DR. MARCUS: I'd be happy to help you. 6 MR. THOMPSON: .You'd like to help me out? Which ' 7 way did I come in? 8 MR. CAMERON: I guess the question here is that 9- -thereLis not necessarily a connection between the need for 10 . risk analysis and the extension of the comment period. I 11 In other words, I think people feel there is a 12 need to extend the comment period even over and apart from l 13 the risk analysis, but there could be a nice tie-in between a i 14 those two.
.\'A) 15 -MR. THOMPSON: I think that is true. I think that,-clearly, there's a need to extend the comment period,
~ 16 '
l 17 and I'm going to declare I got a unanimous of every person 18 here, no objections, that -- 1 19 MR. JOHNSON: Can I just ask-for maybe some 20 ' response from the other attendees about whether it might not 21- even serve us better than that? Of course, we'll all 22- unanimously agree to that, but it might even serve better to 23 get-a new proposed rule with a suitable comment period,-
~24 incorporating what you've heard so far from this venue,
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_ _ . _. .. _. .. . . - _. . _ . _ _ . . ~ - _ _ - . _ _ . - _ _ . _ . 193 1 so forth. l't = \ 2 Where do we stand now with NRC after all this p l 3 input has been received? 4 MR. BROWN: And I'd like to point out I think i l 5 we've brought up sufficient concerns that, really, I think l l 6 NRC would want to go back and take a look at some of these 7 things, and that would mandate pushing.the whole rule timing 8 table back from June '99. I hope we've made that clear with l 9 some of the concerns we've had. , 10 MR. CAMERON: Okay. 11- I think, Hugh, you've done a great job of opening 12 up this subject, and.I: hope that you have some time to. stay 13 with us to hear this discussion, because I think that
, f"'g 14 there's a number of different options on the table all going
'U-l 15 'in the same direction, but let's hear what Aubrey has to say i 16 about it. 17 MR. GODWIN: Well, I'm not opposed to taking a 18 little more time. 19- It seems to me that, really, the justification for L 20' the' approach that you've set up for this rule-making is a 21 risk basis, and obviously, a few folkr, are having difficulty l 22 understanding your risk basis right now.
-23. In order to support the rule package, you ought to i
24 get that cleaned up first, before you move forward with the 25 rule,-because then you can support what you've got in your i
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. ~ 1- rule, and it may develop a lot clearer, which may lead to a 2 new rule development, which may lead to whatever, but I 3 think your supporting material needs to be developed to go l
L 4 along with it at the very least, and that seems to be a 5 little weak at the present time. 6 I know somebody probably feels like they got a ; i 7 real great thing out of that, but we're having difficulty ! L 8 with it. 9 MR. THOMPSON: Thanks. i l 10' MR. . CAMERON: Anybody -- well, first of all, no 11 one disagrees around the table, at least, that an extended ( 12 comment' period would be beneficial, and it also seems that 13 people want the present proposed rule to be informed more r~g. 14 with risk data, and obviously, we've.gotten a lot of L . tg 15- comments on a third. plane. l 16 ~ We've gotten a lot of comments on all the 17 workshops that we could go back and apply to the proposed 18 rule and come out with another proposal. I mean that's also 19_ : another possibility here, and I'm not sure that if anybody
.20 disagrees with any of those three things, extension of
- 21 comment. period, better risk data, incorporate what we've
! 22 heard so far into a new proposal, but all three of those l- 23 things would not necessarily have to happen, correct? L24 In other words, you could extend the comment l 25 period. .You could do better risk data. You wouldn't l- ? 't
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,- 1 necessarily need to incorporate everything into the proposed
's I 2 rule and come out with another proposed rule.
3 DR. NAG: I would think that, if you are going to 4 do a new proposed rule, you do it right from the beginning 5 and incorporate what we have said not only in the workshops 6 but also in professional societies. 7 Now you are getting again an opportunity to do it 8 right, to do it right from the beginning, and this is, I 9 think, where your budget would come in. 10 You have to build it into your budget to have 11 invited people from the societies into those workshops to 12 have direct input and have it right from the beginning. 13 This is what I would urge you to do. (~~g 14 MR. THOMPSON: This is, I think, where one of the V 15 commissions found a dilemma in that we were -- I guess there 16 was so much, I guess, concern that there was dissatisfaction 17 with the current Part 35, that they wanted it re/ised very 18 quickly and put on a time schedule, and there are certain 19 legal requirements when you bring outside individuals in 20 with respect to doing writing and recommendations that it 21 encumbers the process. 22 . Nevertheless, they wanted a big input, and I think 23 we've gotten, certainly, the .'.arge input. 24 I guess I'd like -- I'd just be interested in how 25 many people are really dissatisfied with the current Part n 1
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-sy 1 35?
'- 2 DR. KRAUSE: You mean the proposal or the current 3 one?
~4 MR. THOMPSON: The one that's currently existing. l 25 We've been asking ourselves what is the problem we're trying 6 to fix, and I keep saying it's Part 35, and everybody says ,
l i 7 don't change that Part 35 yet. So, I've been just trying to i 8 get a good sense. 9 I know, you know misadministrations and medical i 10 events and some labeling and terminology are important, that l l 11 'could be done,.but are pecple really concerned with the I 12 existing Part 35? 13 MR. CAMERON: I guess that the decision would be, 14 if there were never going to be a -- how would you answer 15' that question if you knew that there was never going to be a 16 change to the rule? I mean people might be willing to live 17 with it while a better rule was being developed. 18 MR. THOMPSON: Well, I think that seems to be the 19- impression, but I mean, certainly, there's not a big 20 pressing need, an immediacy need to change the current Part l 21 35.
- 22. .
DR. NAG: Okay. I'll tell you, from the 23 Brachia-therapy Society, we feel there are a number of 24 drawbacks, which I will address. However, it's something we 25 can live with temporarily, but what we would like is a
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L n 197 1 change for the better and not, just because a change is
.kos p) . 2 needed, you force and make a change but make the wrong 3 changes. !
4 So, we are willing to live with it for a short 1 5 while, you know, maybe a year or more, but it is not perfect . l 6- at the moment. But it needs change but not in a hurry. l . 7 MR. THOMPSON: Just recognize, if we start back 8 into a rule-making process that's going to do this entire 9 risk base, rule-making usually takes us a couple of years, 10 and if we have to do a ri.k analysis, we're talking 11 potentially three years, four years. 12 I mean when you're looking at -- now, there may be 13 ways we can, you know, truncate some of that, if, you know, 14 the radiopharmaceutical industry has lots of data that may 15 give us some risk data -- there may be risk data around that 16 will help. 17 MR. CAMERON: Okay. Let's take the cards and l 18 start with Carol and go down this way to Roy and Jennifer 19 and then go over to Bob. 20 Carol? 21 DR. MARCUS: In the first place, you've had almost i 22 three. years since the NAS/IOM report, so there is some 23 degree of disappointment if this is what comes out after 24 three years. 25 I would suggest that, before you put a lot of O h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l 198-1 money into redoing the rule, the proposed rule, that you put 2~ out.the risk analysis first, alone, for comment. 3 Basically, if we can buy into the risk analysis, I 4 think the final regulations will probably be acceptable. l 1 5 If we end up with some kind of Mickey Mouse risk 6- analysis that is then used to make_ regulations.that we don't 7- like and a few years have gone by and millions of dollars 8 are spent and we're in the same place again, where we are
- 9. challenging you on the risk analysis itself, it's not going 10 to'be a good thing.
11 We ought to be able to agree up front on your risk 12 analysis and on the. problem you're trying to solve. This, I 13 think, should have come first, right at the beginning, but 14 it never did. I 15 So, I would suggest, along with the delays and the ' 16- risk analysis, a kind of step-wise thing. We really ought 17 to all have consensus on your-risk assessment. 18 We're talking about scientific analysis, and there 19 .ought to be a way that we can all agree that the science is
-20 right.
21_ I don't see why that can't be published before 22 actual regulations get made. 23 MR, CAMERON: Okay. That's one proposal. 24 Jennifer?- 25 MS BUCHOLTZ: I was just going to reiterate, l (s / ANN RILEY-& ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l- _ . - . ._ . __ -~
l 199
,-s 1 being on the IOM committee, I think we did do a lot of site 2 visits, we tried to gather a lot of data, and we did find 3 and we did hear from many authorized users that they were 4 very dissatisfied with Part 35, that it was too 5 prescriptive, thut it impeded in the process of taking care 6 of patients, it impeded in the process of medical care, and 7 that I think they would agree with going along and trying to 8 get it right from the beginning, to do the risk assessment, 9 but however, what the NRC can do and if you go back and look 10 at the alternatives that the IOM committee reported, they 11 could simply relax some of their prescriptive judgements, 12 inspections, punitive actions in the meantime, until we get 13 it right. , (~^) 14 I think those are things well within their power C/
15 to do, and I think that's what authorized users really 16 complained a lot about. 17 There are parts of part 35, such as calibrations, 18 that I think most people agree with Jim that they're very 19 important. Certainly, nobody said for 10 CFR 20 to go away, 20 but I think there are things that can be done in the 21 meantime. 22 . I don't think it was that everybody said it has to 23 stop right today. I think, if you get it right, that's 24 what's important based on risk assessment, but there are 25 certain things the NRC can do.
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1 l 200 1 MR. CAMERON: So, you think that, if I put up here O- 2 interim fix, whatever that would be, interim fix while Part 3- 35 -- while the risk analysis is done? 4 MS. BUCHOLTZ: I think look at the major 5 complaints people had with Part 35 and what I mentioned, 6 being too prescriptive, being too punitive. 7 I heard from an authorized user at a small l 8 institution in Massachusetts, for example, on a site-visit, 9 they were cited for a nurse who wasn't taken-aside during a. 10 code situation with a patient who had an iridium-192 implant l l 11 because she happened to be walking down the floor and she ' 12 was' responding to that code, and they were written up and 13 fined for that, because she didn't have a 20-minute
- 14. in-service on how to take care of a par.ient with 15 radioactivity.
16 Those are the kinds of things that I think people 17 reacted to, and those are the kinds of things I think that 18 can stop. Those are enforcement issues. Those are the 19 issues that people react to and want to get of regulation 2 0 -: because of the way it's evaluated and enforced. 21 So, those things, I think, can happen. That's ! i 22 common sense I think people can look at, and I think the NRC l 23- has shown that they're trying to do that, which is very 1 24 positive, but I think there is dissatisfaction with 35. l1 25 MR. CAMERON: Okay. l t :. L l ANN RILEY & ASSOCIATES, LTD. , Court Reporters I 1025 Connecticut Avenue, 104, Suite.1014 Washington, D.C. 20036 , (202) 842-0034
_ . . . _ _ - _ _ _ . . . _ _ . _ _ _ _ . _ . - _ . . _ = . . - . . = . _ . .l ,- -_ _- . - . . ~ 201 , ~ 1 Roy. 2 MR. BROWN: Chip, I was just going to say exactly 3 what Carol said. In order to do a proper risk-informed 4 development of regulations, you really need to do the risk 5 assessment'first, you need to present it to us, we need to 6 take a look at it, we need to understand where you're coming 7 from in developing this performance-oriented regulation based on a risk-informed -- we need to understand that risk,
~
8 i
- 9. we needito see the risk analysis after you do it. I think 10 that's critical. )
11 MR. CAMERON: Okay. Thanks, Roy. 12 How about Bob? l
~ 13 MR. ZOON: Yes. I just wanted to try and answer 14 Hugh's question. I think, as this effort was launched, !
' '\ ! 15 there was a great deal of hope that what we would end up 16 with is regulatory reform, much less in the way of l 17 regulations. ! 18 I and everybody I've talked to about this thinks 19- that what we've ended up with in the proposal is at least as 20 rigid, if not more rigid, than the existing Part 35, and 21 that's really the problem that we have. We haven't gained 22 anything by this exercise. 23 So, the leading question I had on risk this 24- morning was meant to kind of make people think about, if we o 25 really do a good risk analysis, there might be some O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ; Washington, D.C. 20036 ! (202) 842-0034
l 202 1 activities covered by this regulation and the proposed i 7-~) \
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2 regulation that, in fact, don't need to be regulated because 3 of the low risk. l 4 MR. CAMERON: Marlene? 5 MS. MOORE: I'm going to be a real heretic here. I 6 Look at the number of BEIR reports that have come 7 out over the years. I don't think we're ever going to come 8 to a consensus about the risk, and I think that we need to 9 move ahead with the regulation. 10 I think it's excellent to work toward coming up 11 with a risk assessment, but I don't believe that moving 1 12 ahead with the regulation should be stopped until we've had
]
13 that risk assessment. l l (h \~,) 14 MR. CAMERON: And that's based on the fact that l
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15 you think it's going to be difficult for people to reach l 16 consensus on what a proper risk assessment is. 17 Is it also based on the fact that there are 18 desirable parts of the proposed rule that you think should 19 go forward? 20 MS. MOORE: I think that, as Jennifer said, there 21 is a lot of dissatisfaction with the current Part 35, that 22 there are areas that we need to reform, and on a very 23 practical basis, I think we need to move ahead with those. 24 I don't think that this means that the other 25 cannot be done, and what I would propose is that there, you ("h
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t l l 203 , i i
- ./^N 1 know, be some sort of time table for going back and k_, '2 re-looking at Part 35, 3 But at this point in time, I think'that it's 4 really important that we look at the nuts and bolts of l
l l 5 what's in there. I 6 MR. CAMERON: Could I repeat Hugh's question for 7 ' -- 8 MS. MOORE: With an extended comment period. A 9 lot of people don't know about it. 10 MR. CAMERON: Whatever else we do -- okay -- 11 whatever else happens, there should be an extended comment 12 period. Okay. 13 I know that the IOM report did have a risk 14 assessment in it. Is that correct, first of all.
't 15 Second of all, what did the medical community 16 think of.the risk assessment?
17 Third, how long did that take, and how much money 18 did it cost? 19 Jennifer? 20 MS. BUCHOLTZ: Well, there a risk assessment. 21 There was an invited paper that's in that report. It 22 probably was -- again, I think what Marlene is saying -- 23 data is there. It's how people interpret it, how they 24 present it. 25 Sometimes in reports such as that -- they did try i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
204 73 1 to make a balance between perceived risk and other things
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N' 2 that are also important in public policy making. These are 3 complex issues. 4 It's not just science. I hate to tell you that, 5 but it's not just science, so that there were a lot of 6 issues that were involved with that. 7 There was an attempt to also look at 8 misadministrations, which was the terminology used in '94 to 9 '96, and also based on different types of 10 misadministrations, such as with prescription drugs, blood 11 transfusions, those kinds of things were also in that l 12 report. I 13 Certainly, I think the science is going to support , e' 14 -- we're probably too regulated with ionizing radiation. I 15 think people in this table believe that. I 16 The more that we can do that, I still think the 17 more supported it is to reduce reg 21ation, and I think 18 basing reportable occurrences on things in nuclear medicine 19 with low doses is just too much work, too much paperwork. 20 Patient notification of that, I think is 21 deleterious many times to patients, and NRC still supports 22 that. 23 So, I think there are things that -- we looked at 24 risk assessment, but it wasn't all the complete data, and
-25 you know, I sort of support as a personal support that that ANN RILEY & ASSOCIATES, LTD.
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205 fw 1 needs to be done first, but I do agree with Marlene that
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2 there are certain things that we can do in Part 35 right 3 now.
4 MR. CAMERON: All right. 5 Let's hear from Dr. Fletcher, then from Bill, and 6 then let's go over to Terry. 7 DR. FLETCHER: We're obviously not a 8 policy-setting body, but if that was a motion up there on I 9 the lefthand panel, I would second it, and I think that all 10 of those elements are important to keep on the same page. 11 I think, though, it's very important, before 12 everybody gets going on a risk analysis, to get agreement 13 not after you've done it but before you begin, on what is a
. (~'N 14 risk analysis, what are the components of it, is it risk to l \,,l 15 risk, is it absolute risk, is it relative risk, is it 16 comparative risk, is there risk-benefit considerations, and 17 these things, I think, really need to be agreed to before l 18 the path is set upon.
19 'MR. CAMERON: That's a very good point, because I 20 wonder, as we talk about this -- Carol sort of made an I l 21 assumption, I think, based on the fact that there would be l 22 certain criteria for doing this, that, well, we'll have the i 23 risk assessment, risk analysis, whatever you want to call i 24 it, you know, everybody's goiag to agree on it and then it 25 will be very simple to go forward from there, but I wonder, g~g
+
V) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
1 1 206 f- 1 if you get to the end of this -- if you don't do what Jim Nu ,) '
- 2. said, you may get to the end of the process, and we're going 3 to be back here so much time from now and so much money and 4 we're going to be -- we're going to still be arguing about 1'
5 this. 6 So, I think it's important to think about where 7 we're embarking. 8 David? I'm sorry. Let's go to Bill and then 9 David, professional courtesy. 10 DR. KRAUSE: In speaking for the American College 11 of Radiation Oncology, even if one deregulates the 12 intuitively low-risk things as an interim thing, we believe ; i 13 very strongly that current 35.940, which is the therapeutic ! i
-- which is-the training portion, should not be tampered ; 14 151 with until there's a full hearing. l 16 I'll address this more fully tomorrow in the l 17 session, but if you're going to relax things, I think they 18 ought to be things that are intuitively very -- everybody L 19 sort of can agree with without much fuss.
20 MR. CAMERON: That would be fun. You know, when I 21 think about the interlm fix -- and we all know what's wrong 22 v I'mean I think that that would be -- there would be a lot , 23- of debate about that, perhaps. l l- . . i l; 24 DR. KRAUSE: Can I make one other comment? And I 25 think.part of it relates over here to what Jennifer.said, f
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207 f-sy _1 We are a site that, actually, NRC has brought V - 2 their inspectors in to train. 3 In 18 years, we've had two minor gigs where we had 4 :to put up two signs, which we did before they left, and 5- that's the only faults they found, and yet, every single 6 meeting at'the end of the day always starts out in a totally 7 negative thing -- we have no found no violations, not hey 8 you guys are doing a good job. ] 9 You-know, it just totally blows your mind. I mean 10 here they bring their inspector trainees in, find nothing, 11 and the only thing they can say is we have found no 12 violations. You know,-then they'll go off the record and l l 13 say, hey, you guys are doing a . good job, but it really sends 14 -- what it does is it makes an antagonistic kind of a 15 . set-up. 16 If you're doing a good job, why don't you say 17 you're doing a good job?
, -18 MR. CAMERON: Okay. Regardless of what we do with i l19 this proposed rule, there may be issues enforcement attitude 20 that we do have on the agenda for discussion that I think 21 would apply regardless.
22 . Bill, and then I guess I'd like to hear from the 23 endocrinologists, if they have anything, any feelings on ! i 24 this, and I would also ask, after we hear Bill, for Elena to l ! 25 introduce herself. She's at the table now. t~ i.\- ANN RILEY & ASSOCIATES, LTD. Court Reporters
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l 1 208 1 Bill? 1 ? (~% )
;\_-) 2 DR. VAN DECKER: I agree with some of the things !
3 l that Dr. Fletcher said as far as at least knowing what your i 4 end point is once you put things in motion, because that's 5 very important. 6 I think no one would argue with the necessity of 7 having enough data to make solid decisions for health care 8 in general, but I don't want to leave the table with the i 9 believe that 10 CFR 35 is making everybody happy right now. 10 You know, regulation is cost, and right now, cost, i 11 to us, is problematic, and that paperwork and that resource 12 generation that it takes, and obviously, T&E for diagnostics 13 are probably a tad prescriptive right now, and we have 14 strong feelings about that for patient access and a number (,) 15 of other different issues. 16 So, you know, three years, I think you're talking 17 about a long time there, if you're talking about that type
-18 of a turn-around, but I think that, obviously, gathering 19 more data is always an acceptable matter.
20 MR. CAMERON: Okay. 21 Elena, would you just introduce yourself, and then 22 I'.11 ask whether anybody over here has a comment. 23 MS. RODBARD: Sure. Thank you. 24 I am Elena Rodbard. I'm President of the American 25 Association of Clinical Endocrinologists, and the main ( ) ANN RILEY & ASSOCIATES, LTD.
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- 1 reason we are here is to assure that endccrinologists may be
.2 =able to continue.to provide safe, cost-effective care of
~3 patients with hyperthyroidism and thyroid cancer by the ,
4 . administration-of iodine-131 in an office setting. - 5 MR. CAMERON: .Thanks, Elena. 6: Jack, what do you and your colleagues think about 7 what we're talking about now?
- 8 DR..BASKIN: Well, at the risk of sounding 9 redundant and superfluous, the same thing we said this 10 morning. '
11- We think that changing it just to be. changing the 12- rule, which is what it looks like to us, and making.it more 13 onerous is not what we wanted and what anybody really I 14 expected, and if we're changing it and rushing through,.then ("')
%./
15 we're going to end up, in two or three years, as Carol said, 16 spending millions of dollars and realizing we ended up 17 making it worse instead of better. 18 Why not take more time; even if it-means starting 19 'over and. delaying it three years? We would certainly. favor 20 that. We are.not anxious to change it at all. So, we would 21 love to keep the rule indefinitely, as it now stands, the 22 rule affecting endocrinologists. 23 I' don't know how the others feel. 24 DR. KRAUSE: We agree, I mean in terms of L -25 radiation oncology, +Q I \~/ ANN RILEY-& ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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t 210 1 MR. CAMERON: All right.
' 2 Bill, did you have another comment? And then we l 3- want to go over here to Terry. l l
1
'4 DR. VAN DECKER: There may be pieces of it that 5 people have an indefinite feeling about, but the overall 6 construct in a number of different areas need to be talked
~
1
'7 about.still.
'1 8 MR. CAMERON: Okay. l 9 Terry?-
10 .MR. JOHNSON: .Actually, Mr. Thompson asked the 11 question, is Part 35 so bad now, what we~have right now, and 12- I'm going to offer a very iconoclastic view on that one, 13 because given what I see'here as the proposed rule, I would y
; 14 .rather stick with the old rule permanently. l
.15 I: am a practicing radiation safety officer. I 16: don't'know how to make a living doing anything else than a
- 17. radiation safety officer, and frankly, to see the prospect 18 of radiation safety committees being eliminated from the 19 rule when this is the one thing that gives me clout against 20 management and clout against the physicians who I might have 21 .to deal'with is totally frightening to me, you know, to have 22 the -- now, I'm not suggesting that my university.would !
l 23; eliminate its committee, but.I think that it's.a very 24- essential part of your regulations. I
~
25- And furthermore,.when you consider what H -O ANN RILEY'& ASSOCIATES, LTD. L Court Reporters
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211 1 regulations are written like in general, traffic 2 -regulations, DOT regulations for transporting hazardous-3 ' materials, things like that, these regulations are not 4 really prescriptive, it's the enforcement policy of NRC 5 that's prescriptive. It's the enforcement policy. 6 MR. CAMERON: There may be some disagreement. 7 There may be people out there shaking their heads no, but we 8 will get to inspection and enforcement at some point.
.9 The staff has put a lot of work into this rule and 10 has tried to be responsive to things that they have heard 11 over the years, and you say, well, we'd rather live with l
12 Part 35 than the new rule, but yet, you just mentioned one 1 l 1 13 thing. l
. 14 If the radiation safety committee was kept in the 15 rule, is this still your opinion? I'm just trying to put I 1
16 finer points on some of the things that we're saying, 17 because this type of discussion tends to get really out of 18 hand and you're not sure where you end up.
'19 MR. JOHNSON: Well, I'm also confused about some 20 of the training and experience requirements.
- 21. MR. CAMERON: Okay.
22 . MR. JOHNSON: It's not that I can't live with 23 them. l l
-24 l I think that from the physicians -- what I really 25 think I understand from the physicians, other than the ANN RILEY & ASSOCIATES, LTD.
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212 l
~~ 1 training-and experience requirements, which I think is
\'- . 2 something like a turf battle, what really gets in their craw 3 is that quality management program, the misadministration 4 reporting, and more than anything else, the requirement to J report to the patient, in every case, no matter how trivial 6 it'is.
7 There are cases in tort law going on in the , -8 country right now -- there was a update at the Health
- 9. ' Physics Society meeting in Minneapolis just a few months 10 ago, and one of the cases in -- that's being tried, jury 11 trial, concerns a supposed cancer that developed, and the 12; etiological agent that's to blame in this suit is a !
l 13 purported dose on someone's record of 13 millirems, 13 ) i t'% 14 millirems, and someone is suing over it, and it's going , \ ,] 15' through the courts. l
- 16 Now, I don't know if it will win or lose, but l 17 given the jury system, it has got a very good chance. Even 18 if it were 2 millirems, it would have a good chance of 19 winning..
20 So, to ask physicians to report to the patient a l l l 21 simple mistake that has no real medical consequence, I i 22 think, is a bit much. 23 You won't make many friends in, I don't think,.the 24 physician community by doing that. l 25 MR. CAMERON: Okay. x
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[ 213 , ,- s 1 MR. JOHNSON: But the rule itself is no more lI I
\> 2 prescriptive than other rules we live with in this society.
l 3 MR. CAMERON: Okay. Thank you. 4 I guess one of the big questions here is, if 5 everyone feels that we need to do a risk analysis before we 6 proceed -- and that may validate certain portions of the 7 rule -- proposed rule, it may invalidate certain portions of 8 the proposed rule, okay, so that it's not like it's throwing 9 it all away. 10 I think people assume that they know what's going 11 to happen, but going back to Jim Fletcher's point, how would 12 we agree on a methodology? 13 It's always easy if the NRC decides to do a risk
/~ 14 assessment. We get to the end of it, the people don't like O} 15 the results, and then people .ay, well, they didn't do it 16 correctly.
17 In other words, if the Commission is going to guy 18 into saying, look, we need to just step back and do 19- something differently here, how do we ensure, as much as we 20 can, that what we get down the road is not going to just be 21 thrown away because people don't like the results of the 22 study? 23 Jim Fletcher, you had your card up. Do you want 24 to address that, and we'll go to Carol. 25 DR. FLETCHER: I think I can just address that (g ! \d
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1 214 1 very quickly, and that is I think you have to talk about it. 2 I think you have to communicate. 3 I think that the industry and the profession has 4 to again collaborate very closely about the types of 5 methodologies that are available and, ultimately, with a 6 consensus process, try and adopt one. 7 What I wanted to say, just very quickly, though, 8 about people picking pieces of the existing Part 35 and 9 saying that they're okay and that they need to stay in place 10 and so on -- I think that's probably true, but I mean I 11 think that you need to keep the larger perspective. 12 It seems to me that quality is what we're really 13 interested in here and that safety is one of the elements of 14 quality, and what we really want is a rule that takes the ) 15 best of what exists and the best of what we can get in the 16 future, that will give us quality and safety as a part of 17 that. That's what I would hope we could keep in mind. 18 MR. CAMERON: Okay. 19 Carol, let me go to you in a minute, but just let 20 me make sure -- we heard from Aubrey, in his typically 21 understated way, about.it's always a good idea to get more 22 data. 23- I wondered if the -- if we could hear from the
< 24 other agreement state rep, and Aubrey, you amplify as much 25_ -as you want,.too.
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215 fs 1 What do you guys think about this issue? I \
\/ 2 MR. GAVITT: Well, we support, you know, the idea 3 of having a risk-based approach, but I agree with what's 4 been said, that we have to agree up front exactly what it is 5 that we're going to analyze before we do the analysis and 6 also, as you mentioned, be prepared to make decisions based 7 on that.
8 Right now, we are trying to go through a 9 risk-based approach ourselves with our regulations, and 10 something that we've looked at in terms of coming up with 11 standards or relying on accreditation from other 12 organizations as substitutes to our regulations, but I would 13 support going back and doing what was on the second poster r'~T 14 board up there and re-analyzing.
] 15 MR. CAMERON: Okay.
16 Aubrey, do you want to chime in on this? 17 MR. GODWIN: Yes. Getting the risk methodology 18 down is one thing, but there's really a little twist to it 19 in that what may be acceptable for use in terms of risk to 20 the general public may not be the same risk acceptability 21 basis for patients. 22 . I think Carol Marcus had a real good point in 23- there's a risk-risk comparative there. 24 So, as you look at these situations, there may be 25 more than just a simple, yes, we'll use this methodology to C) \-sI ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i t 1 216 s 1 come and calculate some numbers and, if it exceeds this ( )
\- ' 2 number, we'll do this.
l l 3 I think it's going to be a little more complex l 4 than that, and I don't think we need to go into it blind, 5 and we really need to work together as a group to reach 6 these decisions. ! 7 MR. CAMERON: And that's a good point. l l 8 I'm assuming that those types of issues would be l 9 ironed out in agreeing on the methodology, in other words 10 what has to be included here, you know, the value, risk-risk l 11 point that Carol was stating, for example, some of the l l 12 things that Don Cool was talking about this morning. 13 Carol? [] 14 DR. MARCUS: Thanks. V 15 I have a few points to make. 16 First of all, let's not lose sight of the fact 17 that the Commissioners and the Office of General Counsel 18 have to come to some conclusion on the acceptability of 19 relative risk. In the standards of consideration, they 20 basically said that they thought they could only use 21 absolute risk. 22 - So, number one, that has to be determined. If 23 they determine that they cannot use relative risk, we can't 24 play, because it's not possible to think of medicine 25 intelligently any other way. rx t
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6 217 . i
- gg .1 The Society and the College recommended that the
- 2. Commission use the type of risk analysis in the Presidential 3 and Congressional Commission on Risk Analysis, a two- or 4 three-volume document.that was published in 1997, and it was 5 really very comprehensive and expressed the way that the 6 Government was supposed to approach risk.
j_ 7 If there is something in the Atomic Energy Act c 8 that makes it different than that, it's got to get resolved. 9 Before we even do a risk analysis, we have to know what kind 4 10 of we can do. 1 11 I would recommend that, if, in fact, the ! 12 Commissioners decide that the act does allow , 13 medically-acceptable risk analysis and the components of the
N 14 Presidential / Congressional Commission recommendations on
. . [d 15 risk analysis, that we then can bring in high-quality 16 medical risk analysis people who are not involved in nuclear 17 medicine or radiation oncology to help out. 1 ) 18 NRC can always hire consultants. If you don't ! 4 19 ' feel comfortable working with me -- and I can't understand i l 20 why that would be the case -- you can certainly feel ! 21 comfortable working with guys like Berwick and some of the
-22 best thinkers in medical risk analysis.
- 23. This is a whole field that's been really well 24 done, and there isn't any reason why you can't avail 25 yourself of it, but these are all things that have to kind
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. 4w L 218 f-~ 1 of be decided up front.
- I 2 On the other hand, we have to also know what 3 problem it is 'fou want to solve. This is about the third 4 time I've said it, but really listen. You can't talk about i L 5 solving a problem unless you've defined the problem, 6 I look at a field which, to me, is about the i
7 lowest-risk medical specialty there is, which is nuclear 8 medicine. We pay the lowest malpractice premiums, which l 9 says something, you know, along with rehab medicine and a 10 few.others where it's very low-risk. 11 So, NRC has an obligation to put on the table what I 12 they think is the problem and the hazard and the risk of 13 nuclear medicine before we start talking about how we I 14 evaluate that risk and how we solve the problem, and I o- %.f)) 15- really think that.we ought to be together with you in laying 16 out the problem you see. 17 r It may not turn out to be a real problem, or it 18 may turn out that someone else has taken care of the
-19 problem.
20 MR. CAMERON: Hugh.
-21 MR. THOMPSON: I think the next problem is 22 inspection and enforcement.
23 MR. CAMERON: All right. 24 I think Hugh has the pleasure of trying to carry ; l i 25 this to the Commission, and Cathy probably has the pleasure 4 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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219 1 of trying to summarize this, but I think Hugh would state 2 that we are going to give the Commission an update. 3 MR. THOMPSON: And we will do this very promptly. 4 I do know that this is an issue that the 5 Commission is very interesting in moving promptly in, and
.6- we'll try to capture as best we can the consensua of the 7 assembled group here today to indicate both of these major
.8 issues.
9 I can't predict right now how the Commission will go. ~ 10 I would note I just got a note that we have two new 11 Commissioners now, so we will have a full Commission. 1 12- This is National Y2K Week. I should go into my 13 'Y2K discussions, but I won't. A 14
.g But I do want to hear the next discussion, because 4
15 I think we have issues with inspection and enforcement that 16 have created problems for the current Part 35 as well as -- l 17 is one of the areas that we would want to go forward. 18 If we have to go forward, we certainly don't want 19 to go forward with an inspection and enforcement program l 20 that's counterproductive, and that is an issue I really
- 21. would like to see us address.
22 . 'MR.. CAMERON: Yes. Let's get into that now, 23 because I have a feeling that inspection and enforcement 12 4 issues, no matter where we end up on this, are still going 25 to need to be addressed. h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
220 1 We have Cathy to talk about -- Cathy Haney is 2 going to talk a little bit of the context for inspection, 3 and I believe Joe DelMedico is still here to do the same for l l 4 enforcement. l 5 Cathy, do you want to start ~with the inspection
-6 ' process?
7 MS. HANEY: Yes. Thank you. 8 -Actually, what I'd like to do is just to take it j 9 one step backwards to the licensing to give the~ framework 10 for how we would' envision inspection taking place under the i 11 revised Part 35. j 12 As I stated earlier this morning, we are proposing 13 a change in the licensing philosophy such that~ licensees 14 would not be sending us procedures at the time that they
, ON 15 apply for a license or apply for a license amendment. !
.16 Basically, they would just be telling us that they ;
17 have the procedures that would be needed to address Part 35 !
'18 and that.they would comply with Part 35.
.19 Weihave the guidance document that provides model a: 20 iprocedures, and we talked a little bit this morning about 21 'the role of a model procedure, and Roy Brown mentioned the 22 term --~there are some places in the NUREG where we say 23' "must" or "shall," meaning that the licensee, you know, has
. 24 to have that, if they. don't have that there's going.to be a 25 problem, versus the use of the term "should" or "could."
l
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221 f-~s 1 In the cases where there were musts placed in the
\"
2 NUREG, we tried to have the equivalent regulatory 3 requirement in Part 35, and there may be some places where 4 it's not there, and we'll be examining that during the ! l 5 comment period, but let's assume that we had all the musts 6 and shoulds and shalls worked out nicely in the NUREG l 7 document. 8 What we would see -- you know, once the license 9 was issued, NRC would go out to do an inspection. At the 10 time of the inspection, we would also be looking for a 11 performance-based type of inspection. 12 Basically, we'd be looking for the inspector to go 13 in, to look at what was going on in the facility, observe [~] V 14 operations, talk to the different people involved in the 15 radiation protection program. 16 Obviously, there would be some records that the 17 inspector would look at, something such a dosimetry records, 18 and again, they're kept more for Part 20 than Part 35, and 19 just get a general feel for how the licensee was operating, 20 and then, based on that, potentially that could be the end 21 of the inspection. It wouldn't take five minutes. I nr in 22 it sounds like the perfect world. They could walk in, 23 everything going fine, and then walk away. It's not going 24 to be that short, but basically go in and do a 25 performance-based inspection. t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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j 222 l, _ 1 Now, if the inspector was going out in response to
\-) 2 an incident, to a medical event or in response to, say, an
'3 allegation or just during the routine inspection they 4 identified a specific problem, then the inspector would l
5 start to look a little bit more in-depth at the operation. 6 As they looked more in-depth into operation, they 1 1 7 obviously would get into some of these procedures that the i 8 licensee was required to develop, implement, and maintair., 9 and the question comes up about the adequacy of the 10 procedures. 11 Again, what we're envisioning is that, if --
- 12. obviously, the inspector is going to say let me see your 13 procedure for such-and-such, again if he's looking into an s 14 event in this particular area.
15 In looking at the procedure, yes, he is going to 16 look at the model procedure, but if the model procedure was 17- merely an example.and there was nothing in there that said 18 "must" that isn't in the regulation and as long as they had 19 a' procedure, then thal would be it, there would not be a 20 violation. 21 However, if there was something that was required 22 to be'in the procedure by the rule -- like, for example, 23 . dose calibrator accuracy, the rule now says that the source 24 needs to-NIST-traceable. 25 If the. procedure did not require NIST-traceability
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223 1 and the source was not traceable to NIST and there was a O
\ ,/ 2 problem due to, say, mis-calibration of equipment because a 3 source was not properly calibrated or the dose was not 4 properly used, then there could be a violation, because 5- there's a direct tie to the regulation, not a direct tie to 6 the NUREG.
7 So, it's a very -- the key here is that everything 8 that is a requirement is in the rule and not in the reg 9 guide. 10 The intent is not that the inspector would say, 11 gosh, our model procedure says do A, B, and C in this order 12 and you don't have it in that order, therefore, your 13 procedure is inadequate. 14 So, that's how we envision the use of these k- - 15 inspection -- now the inspections would go on, and then we 16 would step into enforcement, and I will let Joe touch on 17 that. 18 One thing, though, I would like to say is that we 19 are moving, right now, toward more performance-based 20 inspections than the prescriptive-based inspections, and we 21 have been working to revise inspection procedures throughout 22 the whole materials area, and just to give you an idea of 23 the way that we're going, the view-graph that Donna put up 24 for me ic an example of what previously an inspector would 25 go out with, and this, in many different meetings and . O) (, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 224 l I,,\ 1 different conversations I've had with people, has been i \' 2 referred te s the inspector goes out with a checklist and 3 they sit the. t,nd they go through their checklist and they 4 don't leave the facility until they've checked off every one 5 of these blocks and they've checked every requirement.
-6 We have moved away from this in all the materials 7 areas over the last -- probably more so the last year than 8 anything, and we've gone to more of a performance-based or 9 more general approach, where the inspector procedure now 10 looks something -- as Donna is put up now -- more j ust 11 general.
12 So, we've gotten completely away from the 13 checklist. f~ 14 So, what we're looking for the inspectors to do is V' 15 to te'l us something about the facility, to document 16 something about the facility, not go through the specific 17 checklist where they've, you know, almost got blinders on, 18 where they're not seeing things unless it's on this 19 checklist that they work down. 20 We're working in this area right now. The regions 21 seems to be happy with this approach. They're getting more 22 and more used to it. 23 Some of the agreement states are already here 24 using this type of approach. In fact, this was -- we used 25 some of the agreement state input to develop this sort of , f'3
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l 225 ! 1 approach. So, you can see we already are starting to move 2 3 away from this checklisty sort of type of inspection. 4 And then the last thing that I would like to note 5 is -- somebody_is going to ask-the question, where are the 6 inspection procedures for the proposed Part 35? 7 That is something that we will develop. It's one 8 of the things the working group needs to do. We have not-9 done so. To date, our emphasis has been on getting a rule 10 and a reg guide and a medical policy statement out for 11 1 comment. 12 So, it's something that, over the working group 13 meetings that we'll be having over.the next several months, 14 that we would be looking at writing an inspection procedure 15 for the medical licensees that would make it clear, you 16 -know, what the use of the NUREG is, how you rate the musts 17 and the shoulds and the shalls. 18 We would also envision going out to do training l 19 with our regional inspectors, as well as our license I
'20 reviewers, one the approach with Part 35 is more firmed up, 21 how we would do it.
22 . We would go out and train them so they would 23 understand that -- it's almost -- what we're talking about l 24 is a change in philosophy all around, and that's why I 25 started with the licensing process, because it really does , ! i i k ANN RILEY & ASSOCIATES, LTD. g - Court Reporters ! l 1025 Connecticut Avenue, NW, Suite 1014 1 ! Washington, D.C. 20036 (202) 842-0034 i
226 l 1 flow also into-the inspection area.
) '2 At these meetings, when we do get to discuss the 3 inspection procedures, they are public meetings, and the 4
public is invited to attend and come in and talk -- you 5
'know, listen in, and usually we have time to get some input
- 6. from the different organizatiorts that are there about how --
7 you know, their comments on whatever we're talking about. 8 So, I would encourage, you know, people to come to 9 these meetings, becauue we'd appreciate the input. 10 MR. CAMERON: Okay. 11 ! Thanks for that overview, Cathy, including the l 12 note that inspection procedures are being developed, and I 13 think that what we need to do for the rest of the workshop 14 is give us your best shot in terms of what you think about 15 . things on the assumption that some form of the proposed rule
]
16' might go forward, because we don't know what will happen ] 17 . with suggestions about risk analysis, whatever, and granted, 18 these inspection procedures are going to be tied to the i 19 proposed rule and whatever happens. 20 Let's have some comments on what Cathy has set 21 forward here in terms of how the inspection process might d!2 work, and is this -- if it worked like that, is that 23 satisfactory? Are there still concerns? 24 Roy? 25 MR. BROWN: Cathy, you and I have talked about
\
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227 f-- 'l this privately, but I just want to get it on the record. 2 I guess part of the concern with the guidance 3 document is, so many times, guidance documents words and 4 ' guidance documents are taken to be requirements. I mean the 5 inspector may say, well, gee, your procedure doesn't follow 6 with the guidance document, therefore I'm going to turn 7 around and cite you. 8 I mean, especially when you have words like 9 "shall" in there, "shall" can go either way. "Shall" could 10 mean should or "shall" could mean could. I sound like 11 President Clinton.
'12 MR. THOMPSON: I draw the line there.
13 MR ., BROWN: But I think the guidance document or 's. 14 truly needs to be a guidance document. I mean an 15 experienced nuclear medicine department knows how to write 16 their own procedures, they know how to do things properly. 17 They don't need a guidance document. 18 Who needs a guidance document is a new department 19 or a department that's adding nuclear medicine. 20- So, really, all those shalls and shoulds, I think, 21 should be coulds. 22 . MR. CAMERON: Shall be coulds. 23 Carol. 24 DR. MARCUS: We need to go further with that
; 25 guidance document. I don't really understand why most of ANN RILEY & ASSOCIATES, LTD.
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l 228 1 1 those procedures are requirements to begin with. There is j no valid reason for most of them. 2 l 3 I am very worried about the jeopardy that 4 licensees are going to feel when the only time an inspector 5 'looks at a procedure is when something has gone wrong, and I l 6 don't' care,-really, that you say the intent is not to 7 declare the procedure inappropriate. We've had promises 8 -like this from the NRC before. I think it's bothering a lot 9 of licensees. l
- 10. If the procedure is important, number one, l 11 validate why.
12 Number two, you should look at it before you give 13 anyone a license, and you should accept it, up front, so-
-% 14 that you can't turn around and screw a licensee after l
15 .something goes' wrong because you haven't passed judgement on 16 it.yet and can get someone that way. 17 The' licensees'are feeling that they're going to be 18 forced into accepting the model procedures. Let me tell L 19 you, they are terrible. They are medically very bad. They, l . 20 health physics-wise, have no validation. Some of them are .l L 21 dangerous and against regulations of other regulatory 22 agencies. They're just badly done. !
'23 Nobody is going to want to use these model 24 procedures. They're going to feel pressured to use them, u .25 however.
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1 I think that you really have to ask whether you !
=\-//
% 2 need these procedures at all. The, you know, development of
'3 a procedure'and a policy for what a technologist should do !
4 if they don't understand something -- that's ridiculous. If 5 a tech doesn't understand something, they ask. 6 I mean that doesn't need to be a policy and a f 7 procedure development. Neither do we need policies and , 8 procedures for the decrease in generation of radioactive , 9 waste. 10 You know, there are many procedures that are 11 required there that don't seem to be valid, and I think if 12 you are going to require us to do something, you have to 13 sign off on.it up front to protect us so we know that it's . 14 okay.
\
15 I don't think people are comfortable with you 16 making up your mind'after something goes wrong. Your i 17 assurances are fine, but we've got a lot of experience with 18 the agency, and there doesn't seem to much point. If it's
- 19. so unimportant that you're not even going to look at them up 20 front, why do we need them at all?
21 MR. CAMERON: I'd also like to get some comment 22 from people on what Carol just said about why do we need 23 policy and procedures. Are there certain circumstances 24 where this would be helpful? So, think about that.
- 25. And let's go to Paul.
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i 230 l' iMR. EARLY: I think, in response to that, I think ! O\ 2 -that the smaller institution does require some guidelines 3' -and they're looking for that, but they have been so .
-)
4 prescriptive in the past that there's a lot of concern about I i 5 that. i 6 Regardless performance-based inspections, I just l 7- have a lot of trouble with that. I'd be interested to hear 8 how the agreement states that you mentioned, who have 9 already_ started this performance-based approach, are doing 10 with this. ! a 11 My experience with inspectors have always been the j 1 12 checklist, and they are very capable of going through and i l
- 13. picking-out the checklists, and if there's concerns on the l
14 part of-the hospital as to whether they were interpreted 15 right or not, we always felt fairly _ confident that they )
-16 ;would be picked up back at the compliance office and meted 1
-17 .out at that point.
18 I don't know how that's going to happen with 19 performance-based, when you don't know really what's going
-20 on at the time of the inspection. l 21 MR. CAMERON: Okay. Thanks, Paul.
1 22 . On that note, let's go to Aubrey, und then we'll 23 go to Terry and Subir. 24' MR. GODWIN: Well, addressing your last question l 25 first, I think most of the states would feel more p ANN RILEY & ASSOCIATES,_LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Lv _W ashington,.D.C. 20036 (202) 842-0034
r 231
-s 1 comfortable having procedures in to begin with. There's an ~'-
2 old saying down south that, you know, good fences make good 3 neighbors, because if you know what the procedures are and 4 you've both already agreed on them in a licensing document, , 5 then you have a pretty good expectation of what each person : 6 is going to be done. 7 So, I think they'd like that, although I 8 personally and I think several states would like to have 9 more flexibility of being able to change when some things ' 10 are obviously needing changes.
-11 Some of it we'd get a little less formal on, but l
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12 definitely they ought to be in.and agreed to, because I 13 think Dr. Marcus has a very good point, that a gung ho ; 14 inspector can get out.and start making interpretations in
)
the. field that even management won't quickly pick up that's 15 16 maybe not all that good. 17 So, it would be a lot cleaner for the licensee if 18 the procedures were agreed on before the license was issued. 19 To address the compliance problem a little bit, 20 .there are two actors in this compliance problem that have 21 not appeared on the scene yet, and I would like to bring
.22 them up.
23 One of them is auditors. Most states have a 24 program of sunsetting their programs after some definite set l l 25 period of time, typically five or 10 years. Just before the 1 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
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232 yjm i sunset goes through, they have what they call a sunset
~s 2 audit. It's a performance audit of the program.
3 They'll go in, they'll review, and they'll make ' 4 decisions on whether you're enforcing the laws as they're ! 5 supposed to 139. : i 6 We were cited for not doing enough civil ' 7 penalties. This is the legislative arm. It's not the 8 ' executive side doing this, and I know the NRC has -- GAO 9 comes-in and reviews your operations and talks about whether 10 the NRC'is applying the regulations as they have adopted 11 them. 12 There's' case law saying that any official who does l 13~ not follow the law and regulations does so at their personal 14 _ liability and there's been several elected officials who 15 thought they were doing someth.'.ng better, they thought they 16 would earn in particular cases more money by investing 17 slightly different but_not in accordance with state law and ;
-18 they had to pay with their own fortunes -- which brings us 19 to the lawyers.
20 MR. THOMPSON: I.saw Chip sit down. I don't 21 know -- 22 . [ Laughter.) 23 MR. GODWIN: The lawyers get involved and when a 24 ' licensee starts having problems with lawyers, eventually a
- 25. . smart one is going to figure out that he can come to the ,
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,y 1- regulatory agency and get a lot of information, and then ks- 2 they will put your staff on the stand or you, depending on 3 how you are set up,-start asking questions about if they 4 don't do exactly as stated in this, is that a violation?
5 And in'many cases you end up saying yes, and then they ask why didn't you cite them, and then you come back to if you
~
6 7 are not following your regulations, you see, you are 8- personally liable, so you work yourself into a pretty' tight ) 9 box due to these outside influences. 10 Now I must say in our case even though the 11 auditors jumped us about not enforcing with civil penalties, 12 there were no questions raised at the legislative level when 13 we went to testify about that, but you do have these
-- 14- continuous pickings that are going on that are going \-- 15 counter, and I think we need to recognize that as we go 16 through this process -- and I only give this as just 17 information as we go through the process of what the 18 regulator has to deal with in relation to getting 19 appropriations, for example.
20 MR. CAMERON: Thanks for those practical insights, 21 Aubrey and the point you made that corresponded to Carol's 22 point about certainty may be better than flexibility in 23- these particular cases. 24' Terry? 25 MR. JOHNSON: I am not sure I saw the same y-~. (,,) ANN RILEY & ASSOCIATES, LTD.
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, -1 presentation the other viewers did, but from what I thought v 2 I saw, Cathy explained about the enforcement policy and the '
3 inspection methodology that would be used'it looks to me-4 purely beautiful. Now I am not so Pollyanna to believe that 5 NRC would totally give up bean-counting activities and 6 nit-picking details entirely, but just for the agency to 7 have an announced int ention to go in that direction I think 8 is a real breath of fresh air. i 9 As to the burdensomeness of these regulation in f 10 general, through this whole discussion process and whatever i 11 follows, the Atomic Energy Act as amended is not actually 12' going to change. The Congressional oversight of the NRC is l 13 not actually going to change and the American public is not 14 actually going to change, and that is where the physician l 15 groups can really help us get away from prescriptive rules 16 to go out and educate the American people -- stop this ! t l 17 radiophobia where we are more afraid in our society of 18 radiation than any other single thing, save maybe shark 19 attack -- 20 [ Laughter. ] 21 MR. JOHNSON: And if the physicians -- 22 . MR. CAMERON: We are all going to be working for l 23 that agency. 24 [ Laughter.]
'25 DR. MARCUS: We work for a living. That is not !'kp[ ANN RILEY & ASSOCIATES, LTD.
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. f'N - 1 our' job. '
'N s -
,) 1 2 MR. JOHNSON: I know it's not your job but if you 1 3 want less prescriptive regulations, that's one way to:go 4 ~ about-it.
5 MR. CAMERON: I think this is probably a good j 6 off-line discussion --
- 7. [ Laughter.]
8- MR. CAMERON: -- and I am not sure it's a good 9 discussion but I just want to -- going to your point about 10 '"they sounded beautiful," Cathy, it was in the intent or it 11 is the intent of the group that we are trying to implement a l 12 less onerous regime in terms of the license community by 13 these new inspection procedures. $/N l 14 Is that true? I mean --
'15 MS. HANEY: Yes. It is true. I think our view of 1
! 16 not looking at the inspection procedures -- the procedures 17' -upfront at the time of licensing was to give the licensee 18 more flexibility to allow'them to tailor the program to l l 19. themself -- their own facility and also as changes needed to l be made in those programs the licensees could go ahead and 20 21 do it under the current regulatory regime. I 22 - If they made a change in a procedure or something i - 23 they had sent to NRC, more than likely that would require a
'24 license amendment, hence a licensing fee, and they could not 25 do it until it was approved by NRC, so even more 4
4' V - ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut. Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 236 ] 7 .s 1 importantly, it is costing them time as compared to costing
. 2 'them money.
3 So our reason for -- well, one of the reasons for 4 not looking at the procedures upfront is again to give the licensee the ability to change their procedures when need 1 5 6 be, and to put the burden onto the licensee for developing '
'7 what fits their particular operation rather than us saying 8 this is the way that you must do it.
l 9 Along the line with the inspection the idea is l 10 that we would come in and we would really be focusing on the l 11 radiation safety on the bigger picture items as compared to
- 12. getting into the more focused, nit-picky, you know, if you I i
13' had to do a survey every day of the week, did you do it 7'"g 14 .every day? -- more looking at what's your compliance with V -15 Part 20 -- so the intent is to, really is to lessen the 16 regulatory burden, the regulatory impact on the licensee. 17 Now in the cases where the licensee does not have , 18 a good program, then they are going to say, no, you came in 19 and you made our life more miserable, but I am speaking more
'20 to the general licensee -- to the average licensee and the ,
l 21' better licensees that we have out there. I 22 . MR. CAMERON: Hugh? l 23 MR. THOMPSON: I think that we are trying to focus 24 our inspection activities both in the medical area as well 25 as the reactor-area on those things that are important to
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237 1- safety, those things that have the bigger risk as well as to
.A 2 in fact where yco be let's say less onerous on those who are L
l p
-3, performing we]l and then for those who aren't performing 4 well, more enerous than we currently are, so in essence if 5 you find somebody who is really in trouble you need to put 6 your resources there to' find out what the problems are, and l
- 7. we are really probably more advanced in the reactor area 8 than we are in the non-reactor area where we are looking --
l 9 but we are still struggling even in that area to get the I 10 right metrics, what are the right metrics you are looking i 11 at, and so I think what we are focusing here is just a kind i 12- of' focus on those areas which are important from the overall j ' 1 13 health and safety issues. ' , .14 MR. CAMERON: Okay. Let's go down -- Subir and ;
\ -- 15 then Mary and then Mickey and Paul, you have your card up
- 16 . .took and then I think we need to reassess where we are 17 before1we go into enforcement, if we go into enforcement. i 18 Go ahead, Subir.
19 DR. NAG: I think the licensing and enforcement 20 issues have to be discussed together and not in isolation 21 because part of the licensing issue will depend on how you L 22 are going to enforce it.
=23 Your intentions may be quite different from what 24' is going to happen in practice. You know, you may have the 25 best of intentions but what happens in practice may be i
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238 gr 1 totally different. 2 What our feeling is on th'e licensing will depend 3 on what your enforcement issue or what your enforcement ; 4 method is finally going to end up upon -- in fact, that the 5- license is submitted, looked at and approved and allow us to 6 modify it if needed because otherwise we will be going by 7 our licensee rules -- you know, what we made for ourselves 8 -and you may feel that's quite different, and therefore you 9 are enforcing it in a different way, and that will -- you 10 know, I think some of these issues may have to be rehashed i 11 after we have discussed what the different enforcement 12 issues would be. 13 In terms of whether any guidelines are needed, I
/ 14 think it would be better to have the guidelines but to have l
':05 it developed by people who are more knowledgeable in the 16 field -- for example, by members of AMP, ABS, et cetera, and t-l 17 then we are -- then it will be much better guidelines to 18 follow.
- 09 Yes, we need more guidelines, but no, we do not 20 need -- we need better guidelines than the ones you have
- 21 here.
i
- l. 12 2 -
MR. CAMERON: Okay, thank you, Subir. Mary? 23 MS. FOX: The frequency of inspections, is that 24 going to staying the same? 25 MS. HANEY: It's one thing that we will look at l
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239 jes-s . 1- and so it may change but I don't want to commit to it, but
'~
2 we will be looking at everything that is touched by the rule change. 4 MS. FOX: Okay. It seems to me that the NRC is 5- making an' attempt to become more friendly. The last time 6~ they inspected -- you know, I think you changed your > 7 regulations to go to two to three years instead of five but 8 then you get inspected and then they say you are doing a ! 1 9 great job -- I did hear that -- and we won't come back for 10 -five years. 11 MS. HANEY: Right. 1 12 MS. FOX: So your inspections are also it seems 13 like going toward an avenue to be less prescriptive. 14 You are saying your regulations are less 15 prescriptive so then your inspection is going to be, like 16 you said, more performance-based, and someone will come in 17 and just sort of get an idea -- gee, this is going okay, and 18 what I worry about that is that while I agree with it and I 19 think it is a nice idea, I am afraid that the interpretation 20 of now we are doing might just be up to the inspector and 21 you can get~into a little battle, which is why we need this 1 22 guide, because if you are doing what the guide says, like it 23 or not, then that would at least be a concrete example of -- 24 instead of leaving it up to the interpretation of the 25 inspector.
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240 g 1 Also in here, this guide clearly states, you know, 2 please read it and comment on it, so I want it to be taken 3 back to the Commissioner loud and clear that this is a 4 pretty heavy document -- it looks like Regulatory Guide 5 8.1 -- but there could be some improvements made from 6 "shoulds" to "shalls" to whatever, so we do need to go 7 through this and look at it so that we don't have something 8 left up to the interpretation, and I would just like to 9 reiterate that, number one, I want the comment period to be 10 extended, but, number two, if we can go ahead and do it 11 right I am willing to wait three years on Part 35, but this 12 really does need to be gone through clearly so that your 13 inspection process will go smoother. f' 14 MR. CAMERON: So one more, another reason why the ,T . 15 comment period should be extended, and you see the value of i 16 having the procedures, because that provides a protection 17 .against the unfettered discretion of the inspection person. 18 MS. FOX: Yes. 19 MR. CAMERON: Cathy, do you want to comment on 20 that? 21 MS. HANEY: Well, one thing I would like to 22 address was the inspection interval. We do have a program in 23' place now with all materials licensees that if we go out and 24 inspect and if it is -- I can't tell you all the criteria -- 25 -but basically there are no significant findings that we can
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241
,_ 1 extend the inspection interval and the regions are really --
f o As s' 2 are being watched as they are implementing this now, so you 3 are probably starting to see the effects of that. 4 Usually if you have no civil penalties, just a few 5- severity level 4s, which are your more minor violations, we 6 are. going to extending the time period, and it could be as 7 high as moving someone that's inspected every three years up 8 to every five year, so there is a lot of leeway and a lot of 9 licensees have positive feedback on it. 10 MR. THOMPSON: I must admit the counterpart is 11 there -- if we find that the licensee is not performing 12 well, we'll come back sooner, so I mean it is a balance, and 13 in fact we look at that with the agreement states and the , f- 14 agreement states are also looking at that kind of approach l. 15 too. 16 MS. FOX: I also just.want to say that I feel that 17 we are moving more toward -- away from a "we" versus "they" 18 kind of thing. I mean you guys are asking for our input, 19 need our help;and I think we all need to work together on 20 that, and the fact that you have even solicited the idea 21 that we can extend the comment period and perhaps explore 22 reviewing this whole thing is commendable. 23 I am hoping that whoever inspects me next feels 24 the same way. 25 [ Laughter.] b V ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.-20036 (202) 842-0034
m - - - . _ . .. . _ _ ,m.. l-242 1 MR. CAMERON: Thanks, Mary. Mickey? > 2 MS. CLARKE: Building on what Mary said, I would 3 suggest to you that there are places who will want to have 4 their policies looked at with submission of the license 5 application and is there no reason why that couldn't be done 6 if they requested it? 7 I can see the fear that would build up where your 8 policies wouldn't be looked at until you had an inspector
- 9. isolated in your facility rather than submitting them with 10 the application for group review, so to speak, in-house 11 here,' if that is what the licensee wanted to do.
12 I suspect that we would never do that, but -- 13 [ Laughter.)
-s 14 MS. CLARKE: -- but there are places who probably '/ -- 15 -would.
16 MS. HANEY: The working group didn't spend a whole 17 lot of time talking about that, but I would not see, you 18 know, if someone asked.us to review their procedures we 19 would probably look at them. 20 The other thing too that I want to note is that 21 when an inspector comes out, the intent is they would not 22 look at every procedure when they go out. 23 MS. CLARKE: Well, the interpretation is subjecc 24 to a sole person in your facility with no group discussion. 25 MS. HANEY: Right, but --
/~')
V ANN RILEY & ASFOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
243 1 MS. CLARKE: It's you and him. 3-- 2 MS. HANEY: Right, but I just -- I just want to be
'3 sure that, you know, don't' expect the inspector to come out 4 and sit in there and say let me see the, you know, number, 5 every procedure that you have had to develop to be compliant 6 with Part 35.and'let me sit there and go through it. That's 7 not what we want our inspectors doing right now.
8 MR. CAMERON: ' Cathy, could you -- could-we send 9 notices to at least the participants around the table of 10 when the working group meetings are going to be on the 11 inspection procedures, instead of relying the Federal 12: Register? 13 MS. HANEY: Sure. 14 :MR. CAMERON: All right. 15 MR. EARLY: I'think you are saying the right words 16 here in performance-based' inspection. I have a lot of 17 trouble with it, as I mentioned before. 18 I-think it will probably require almost a 19 mind-altering program with the'present inspectors that you 20 have because they are so used to going down the checklist. 21 I think the best example of that is the last time 22 you tried something less than prescriptive -- the QMP 23 program -- and to this day -- I mean it certainly is maybe 24 the most prescriptive. It turned out to be the most 25 prescriptive program that we have got, I think. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
244 .- 1 Even to this day inspectors have spent at least 25 (NJ). 2 percent of their time on the QMP. 3 ;MR . CAMERON: Okay. Thanks for that caution, 4 Paul,
- 5. We.are over time. We have one more item on the ,
6 agenda and Joe DelMedico is with us. 7 Can people stay for about 20' minutes more, to 8 discuss this enforcement issue? 9 Joe? 10 MR. DEL MEDICO: Thank you, Chip. Coming last, I 11 think that many of my remarks will be a reflection of what 12 has already been said here but you might feel more 13 . comfortable hearing it from someone who is part of the 3 14 Office of Enforcement. Then again, maybe you will feel less ()g 15 comfortable -- I' don't know.
-16. First,-let me take a minute or so to talk about 17 the role of the Office of Enforcement at NRC. During these 18 public meetings I have noticed that there is a misperception 19 about how large we are and what it is that we.actually do,
~20 and then after that I will discuss how NRC enforces l 21 performance-based and this whole thing takes about five 122 minutes and after that if you have comments we'll address 23 them, and if not, maybe we're done for today.
2
.4 As far as the size of the Office of Enforcement,
'25 at the absolute maximum we consist of about 16 people and O.
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- 1 that includes secretaries and managers. Roughly a third of 2 the' professional-staff are commercial nuclear power experts, 3 a thir'd are_ experts in the medical and industrial use of t
41 materials, and a third have legal expertise. 5 My own background is nuclear medicine technology, l
;6 radiopharmaceutical science.
t
- 7. .As a. matter of fact, I am one of Paul.Early's - .I i
8 won't embarrass Paul or myself by saying how long ago that 9- was. >
. 10 The reason though that I mention our size :Us that 11: from.the comments at these meetings I think people sometimes !
12 get the ideafthat we are. 200-300 strong _and taat we march i 13 'through the land sort of the way Sherman moved south during
- l,.
14 the Civil War. X : 15' Actually, the inspectors who visit your' facilities i [ i
'16 take,their direction from the Office of Material l-17 Safeguards -- Cathy Haney's office -- and as a matter of 18 fact, as Cathy mentioned, she would be responsible for 191 providing inspection guidance for the Part 35 that an 20 inspector.would follow.
'21 Additionally, the safety significance of
. violations'in the materials area is determined by input from h 22 23 Cathy's office, so the point here is that enforcement of the
!. 24 new Part 35 would be a coordinated effort and would follow r - 25 the general philosophy that Cathy was pointing out. r ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C, 20036 4 (202) 842-0034
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I l 246 'l, 1 Our function, the function'of the Office of i f i 2 . Enforcement, is to ensure consistency of enforcement actions j 1 3 that are taken by the' regional offices and "re do this by l 4~ reviewing proposed escalated enforcement actions before they 5 are issued or for some very routine types of cases auditing ) 1 6 enforcement actions after inspection. 7 We also publish and maintain a written enforcement !
.8 policy that describes how and when enforcement actions will 9 be taken and'what type of enforcement action is appropriate 10 for specific types of violation.
11 We published this policy in NUREG form, so that it 12 is available to the public. It is called NUREG 1600, and 13 right now.we are at NUREG 1600, Revision 1. That document 14 is available on NRC's website, so you do not necessarily have to have a hard copy.
'15
'16 Additionally, we'll put'out more detailed written 17 -guidance to the NRC Staff on how to interpret.the 18 enforcement policy of certain aspects of the enforcement ,
l s19- process.should be conducted and carried out. We do that in l 20- an enforcement manual which is updated periodically and also ) 21 in enforcement guidance memoranda which are issued to 22 address a particular topic in between updates of the manual. 1 23 Both of those documents, although they are guidance to the 24 ~NRC' Staff, are also available on NRC's website. 25 Now to my second point, enforcement of a ' i O
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,_s 1 performance-based rule, as we have been discussing today,
- 2 many aspects of this change are performance-based, and this 3 has raised questions about how a performance-based i
4 inspection is conducted. Cathy and I are both in agreement l 5 that there would be a need for significant new direction to 6 inspectors and that this would be accomplished through . i 7 changes to the inspection manual and retraining of 8 inspectors. I i 9 As Cathy mentioned, we're to take the lead on l 1 10 providing this new direction. 11 As far as our role in enforcing a 12 performance-based rule, first of all, let me say I have 13 occasionally heard the comment that this rule shouldn't have
. (~3 14 to be enforced or that this rule should not be enforceable, i
15 and when I hear that I . d: of translate that in my mind 16 into perhaps we don't need this rule or perhaps this rule ) 17 should change. 18 Those latter points are things that we can debate, j l 19 but once a decision is made to publish a rule in final form, 20 we do expect it to be complied with and Enforcement is the 21 agency tool that is used to ensure that this happens. That 22 is why NRC requirements must be enforceable. ! 23 As a matter of fact, this was the first question 24 that the Chairman of our agency asked when the Staff was 25 presenting proposed Part 35 to the Commission.. Our Chairman
.C'
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248 f~s 1 hadn't even gotten through opening remarks and she stopped
-- 2 suddenly and turned, looked at Cathy, and she said now I ask ,
3 you, is this rule enforceable? So, you know, that sort of 4 emphasizes where we are with this. 5 As to how a performance-based requirement is 6 enforced, there are two hallmarks of a performance-based l 7 rule. 8- First, there is a requirement for a licensee to ! 9 develop and implement procedures to achieve a stated goal, 10 and the second hallmark is that NRC issues guidance on what 11 the agency finds to be acceptable in the way of its 12 procedures. ; 13 This second hallmark, the guidance, is very , 1 r'~N .14 important because it establishes a common understanding I
.) 15 between agency and the licensee as to what sort of l 16 procedures were judged acceptable.
17 Back when I did licensing, I used to be accused of 18 " Bring me a rock" syndrome. Well, if we didn't put out 19 guidance on what we find acceptable to fulfill a j 20 performance-based rule it would sort of be like the agency 21 'saying collect up some rocks and keep them in your filing l 22 cabinet and, you know, if some of the comments today have l 23 brought about later an inspector who arrived on-site could l 24 look in the file cabinet and say, oh, sorry, wrong rocks. 25 So the key is this requirement to develop and (%.
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249
,s 1 implement' procedures to achieve a stated goal and where the / \
(/ _ 2 rule says implement procedures, it means follow the 3 procedures that you have developed yourself, so if there is 4 some issue that comes up at your facility and we find that 5 you have prepared very fine procedures that you have never 6 trained your staff in following and this in turn has led to 7 a performance issue, that would be a violation. You have 8 not in that case followed the regulatory requirement to ' 9 implement the procedure. y 10 - - - - - - ~ 4 to summarize then, in a performance-based rule 11 you decide and prepare your own procedures informed by NRC 12 guidance and then you make certain that you follow those 13 procedures. 73 14 As to how we check, Cathy has indicated that on N]'- 15 routine inspections.the inspector would not be looking at 16 the procedures that you developed for the performance-based 17 portions of the rule. So then what would we look at? As 18 Cathy has mentioned, we would r examining performance by 19 looking at such things as dosimetry records, by doing 20 confirmatory surveys, by holding discussions with employees, 21 and by reviewing records of the licensee's own audits to 22 assure ourselves that the licensee is finding and correcting j 23 its own problems.
- 24 Also, some portions of proposed Part 35 are not 25 performance-based and we would be reviewing compliance with j"~ \
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250 _y-w 1 those portions. The indication here is that if compliance N. g)- 2 with those portions would then be compliance with
- 3. performance-based portions as well --
4 Cathy touched a little on the fact that there is a 5 second type of inspection called the reactive inspection 6 that may occur following some event or incident, for 7 example, following a reportable medical event or l 8 contamination incident. These type of events may be an 9 indication of poor performance on the part of a licensee 10 where they may simply be unavoidable random human error and 11 in order to differentiate this type of inspection, we would i 12 be checking more carefully relevant procedures that the i 13 licensee has developed, f 14 The first question of course would be does the .j
)
15 licensee have the procedures and are they in place. The 16 second question would be were the procedures followed in ) 17 this particular event. Clearly.if the answer is no, then 18 there is a violation to be dealt with. 19 Another question that might be asked is has the 20 licensee provided tools that employees need to follow the 21 procedure. A simplistic example is let's say the procedure 22 calls for a survey meter and the licensee hasn't provided 23 one. Well, then I think we have found a problem, but more 24 often what we see is that the procedures give employees lots l
-- 2 5 of things to do and Management doesn't give the employees ~O /
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l 251 1 the time to do those things, and this is one type of 2 management issue. 3 Lastly, if NRC has satic'fied itself on all of 4 those points, we would want to examine whether the licensee 5 procedure is adequate. That is, does the procedure 6 adequately address the pciformance issue -- and this is 7 where that second hallmark is impcrtant, the fact that NRC 8 had previously put out guidance in a model procedure. 9 I want to emphasize this -- there is no 10 requirement that the licensee adopt the model procedure as a 11 license condition, tied the licensing to a procedure, but 12 where there is a question concerning a performance problem 13 that.is a reportable event, they look at whether the f-s t 14 licensee's procedures at least provide an equivalent degree 15' of safety. 16 Let's say, for example, that NRC's model procedure 17 addresses a certain major aspect or area and the licensee's 18 procedures are entirely silent on the aspect or area, and in 19 addition the medical event involves that very aspect. Well, 20 in such a case it is very possible that the licensee's 21 procedure would be judged inadequate, which also would be a 22 violation of the requirement. 23 As has been brought out here this afternoon, that 24 latter point means that the draft guidance that accompanies 25 the proposed Part 35 does deserve your attention, just as
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252 the rule itself does, although it would be uncommon during a (' 1 2 routine inspection there may arise an instance where the 3 adequacy of the procedure that we have developed and 4 implemented would be judged and in doing so we wou d be 5 taking some broad direction on model procedures and NRC 6 guidance. After all, that's the reason that the model 7 procedures were developed in the first place is to put NRC 8 on notice as to what NRC considers adequate. 9 Chip, you usually like me to leave plenty of time 10 for comments. I don't know at this hour exactly -- 11 MR. CAMERON: Yes. This is an important area and 12 I think there may be a lot of comment on this, and I don't 13 think it is fair to keep all of your here past 5:30. I
-g 14 think that maybe we could begin a discussion and then start (J 15 off tomorrow and have a little bit on this.
16 Joe, is it possible for you to be here tomorrow at 17 8:3C?
.18 MR. DEL MEDICO: Yes.
19 MR. CAMERON: All right. Well, let's have a few 20 comments and then see if we can pick this thread up tomorrow 21 morning to see who else needs to comment on this. 22 - Carol, you look like you are rarin' to go. 23 (Laughter.] 24 DR. MARCUP: You know, this reminds me of the NAS 25 IOM hearings when Mr. Lieberman discussed enforcement and f_. I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
_ . _ . . - . . _ - _ . ., 7,7_
- Y 253 p 1 one of the members of the NAS IOM committee got so upset he 2 screamed, " Shut up -- shut up, I can't stand listening to '
3 you anymore." l 4 'l Joe, you are talking about -- ' 5 MR. DEL MEDICO: You can do that, Carol, if you 6 like.
- 7. DR. MARCUS: You are not talking about a [
8 performance standard. You are talking about prescriptive 9 regulation, exactly what we are trying to get out of. l
- 10. I think there is really a problem. If a licensee 11 hardly ever has a mistake in giving a radiopharmaceutical to 12 a patient, if the workers in the department don't get )
13 overexposures according to Part 20 standards, if members of 1 i 14 the public don't get overexposures, and if the environmental 15 limits are followed, that is a performance standard -- I 161 don't care how he gets there. He's fine. 17 What you'have done is defined many, many, many, 18 many prescriptive regulations that tell someone how you 19 think.they ought to achieve that goal and if they don't do 20 it that way, they.get dinged. 21 Thct's. prescriptive regulation and that's what we 22 are trying to get rid of. 23- .How many -- just for my own interest -- I'm sure 24 'some of us'have questions -- how many instances are there in 25 nuclear medicine in the country.where workers get doses p ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 y- . _ _ _ . , . - - . ,-. .
l l i 254
,, 1 above the legal limits, where members of the public have N- 2 documented doses above the legal limits, and where there are :
3 environmental releases above the legal limits. 4 Remember, we have 11 million procedures a year or 5 12 million procedures a year. How many times does that 6 happen a year? 7 MR. DEL MEDICO: We normally do not see 8 enforcement actions on standards so -- 9 DR. MARCUS: Okay. That is your basic safety i I 10 standard. We don't have a safety problem, number one. 11 If years go by and maybe there will be one example j 12 of a hand dose or something or more likely a film edge got 13 tnrown down and got contaminated or a box of radioactive
- s. 14 material shipment was put right next to it so it registered 15 a dose but the person didn't get the dose.
16 l We don't have a safety problem in nuclear 17 medicine. If our misadministration rate for therapy was one 18 in 10,000 and it's something like seven or eight percent in 19 the rest of medicine, we don't'have a problem there either. 20 What I am trying to get at is that we don't have a ] 21 ' safety problem in this field. You are creating violations 22 .and punishments for violations without demonstrating that i 23 the performance standard of safety was not followed, and ) 24' that is our fundamental problem, and that is going to
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1 l 255 i
-- 1 attitude because we don't accept these prescriptive and 5 s# 2 unacceptable directionG on how to do things.
3 They are written by people who have never 4 practiced nuclear medicine and don't seem to understand a I 5 lot of the details here. 6 We are not interested in you using these to judge I 7 our procedures because we don't respect these to begin with, i 8 Those of us who have read them have a real problem with them 9 and the bottom line is if there hasn't been a safety issue, 10 what are you even bothering with? Why is there any problem 1 11 at all for you to make a big deal about if no one is getting 1 12 overdosed, if Part 20 is okay? ' 13 That is our real question. When you talk about 14 performance standard, that is what it means, that things are d(^T 15 safe. You have replaced precise prescriptive regulation 16 with vague prescriptive regulation and you are calling it 1 17 performance standard and it is not. 18 MR. CAMERON: Okay. Thanks, Carol, and I guess I 19 would like everybody -- we are going to go to Subir for the 20 last comment. We will revisit this issue tomorrow, but I 21 would like to test Carol's thoughts with all of you tomorrow 22 to see how this should be done. 23 Subir? 24 DR. NAG: The American Brachytherapy Cociety feels 25- that there are serious problems in the NRC regulation. In \ s_) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
256 7s 1 our experience we feel that the adversarial enforcement (\ -) 2 system that you have that punishes institutions for isolated 3 violations regardless of the overall quality program and the 4 complexity and the size of the licensed brachytherapy 5 program, and often cited are the violations that involve 6 either administrative or recordkeeping or insignificant 7 technical error that really have no bearing on patient j 8 safety, and that has to, you know, has to go. l 9 There is a tendency to impose restrictive and j i 10 burdensome regulation on brachytherapy delivery and the 11 patient-physician relationship is therefore compromised , i 12 without assessing the risk reduction benefit to the public l 13 or the patient relative to the cost. I ('N 14 Therefore, we endorse the following basic
]
(' 15 principles as a guide -- one, the rules should emphasize the 16 training which I guess we'll talk about tomorrow -- 17 professional staff rather than the prospective rule. On the 18 quality assurance and other technical regulations it depends 19 on the available practice standards that are already 20 available. Resist the temptation to promulgate regulation 21 in the absence of demonstrated risk to the public or for 22 patient safety, and develop enforcement processes based on 23 the overall quality of clinical practice rather than on 24 isolated rule and license conditions. 25 I think what you said reinforces that -- I mean \- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
257 1 our peers. Here we are -- we were thinking that we are 2 getting away from prescriptive rules, but the Enforcement 3 arm has the policeman mentality that, you know, here we have 4 this rule and therefore we have to find the fault and 5 therefore there would be a punitive action. 6 Secondly, we have now made it worse because now 7 our license will not reviewed in one and therefore we will 8 be having a second violation for not having the proper 9 procedure to begin with which we were not aware of. 10 I think we have to rethink this even in more 11 detail and I think we are going to the other thing about 12 training, et cetera, how we can have a better system rather 13 than the prescriptive one when we talk about training so 14 forth in the model. 15 MR. CAMERON: Okay. Thanks, Subir, and Joe, I 16 would just ask you to think about the remarks so far and 17 perhaps you might have questions for people yourself about 18 the issues that were raised. 19 We will give this a half-hour, max, tomorrow 20 morning starting at 8:30 and we will go to the public for 21 these questions. 22 . We are going to get to some specific provisions of 23 the rule and Mary will be happy to know that we will hear in 24 spades from the endocrinologists -- 25 MS. FOX: And others. When is the tour? (f ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ . _ __ _ _ .7; 258 1 MR. CAMERON: The tour? (~- . ( ,e 2 MS. FOX: Yes. 3 MR. CAMERON: The buses will be leaving -- 4 MS. FOX: No, no, I mean the tour of your ! 5 building. I would like to -- 6 MR. THOMPSON: Oh, we can do a tour at the 1 7 Response Center. 8 MR. CAMERON: Less painful than this though. l 9 We will reconvene and we do have a special panel l 10 tomorrow and I may need to ask some of you to perhaps sit in 11 the first tier so that we can bring up that special panel i 12 from the boards to talk about that one provision of the rule I 13 Land maybe stand on the stage.
- 14. Thank you all for your patience and your comments 15 today.
16 (Whereupon, at 5:33 p.m., the meeting was 17 recessed,.to reconvene at 8:30 a.m., Thursday, October 22, . 18 1998.] 19 L 20-21 22- . i 23 Jf
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4 REPORTER'S CERTIFICATE This.is to certify that the attached proceedings before.zthe United States Nuclear Regulatory Commission in the matter.of: ! NAME OF PROCEEDING: PUBLIC MEETING: PROPOSED REVISION OF PART 35 AND THE NRC'S MEDICAL POLICY STATEMENT l l-CASE NUMBER: i. I' PLACE OF PROCEEDING: Rockville, MD were' held as herein appears, and that this is the original
- l. A transcript thereof for the file of the United States Nuclear
!Q l1 . Regulatory' Commission taken by me and thereafter reduced to I'
. . typewriting by me or under the direction of the court l= reporting company, and that the transcript is a-true and i
l accurate record of the foregoing proceedings, t l Mark Mahoney q. Official Reporter Ann Riley & Associates, Ltd. h l I l p
- = --}}