ML20217P482
| ML20217P482 | |
| Person / Time | |
|---|---|
| Issue date: | 10/20/1999 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| References | |
| NACMUI, NUDOCS 9910290309 | |
| Download: ML20217P482 (148) | |
Text
OFFICIAL TRANSCRIPT OF PROCEEDINGS UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
Title:
ADVISORY COMMITTEE ON THE MEDICAL USES OF IOSTOPES I :
(ACMUI) ,
Case No.:
Work Order No.: ASB-300-960 0
LOCATION: Rockville, MD gX
/o/
r DATE: Wednesday, October 20,1999 PAGES: 1 - 108 ANN RILEY & ASSOCIATES, LTD.
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PROCEEDINGS >
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[2:05 p.m]
3 DR. CERQUEIRA: Good afternoon. My name is Manual 4' Cerqueira. In Dr. Stitt's absence, I'm going to be interim chair for'today's meeting.
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5 I would like to turn the meeting !
6- 'over at this time to Cathy Haney from the NRC. !
7 MS. HANEY: I am going to read the official 8 opening remarks for the meeting.
9 I am pleased to welcome you to Rockville for the 10 public meeting of the ACMUI. My name is Cathy Haney. I'm 11- an acting branch chief of the Rulemaking and Guidance Branch 12 and I have been designated as the federal official for the i3 . advisory committee, 14' This'is an announced meeting of the committee. It
-15 is being held in accordance with the rules and regulations
'16 of the Federal Advisory Committee Act and the Nuclear 17' Regulatory Commission. The meeting was announced in the 18 . Federal Register in; September and the meeting notice 19 indicated that the meeting would start at two o' clock.
20- The function of the advisory committee is to I 21 advise the staff on issues and questions that-arise on the 22 ' medical ~use of byproduct material. The committee provides 23- counsel to the-staff'but does not determine or direct.the !
24 actual decisions of'the' staff or the Commission.
.25 ' The-NRC solicits the opinions of'the council and ANN =RILEY & ASSOCIATES, LTD.
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1 1: UNITED STATES OF AMERICA
- 2 NUCLEAR REGULATORY' COMMISSION w
3- ***
.4- ~ ADVISORY COMMITTEE ON THE MEDICAL USES
~
5 OF IOSTOPES (AC"UI)
.6" 7
8 Nuclear Regulatory Commission 9 - Two White Flint North 10 -Room T2D3 11 Rockville, Maryland 12 13 Wednesday, October 20, 1999
.14 -
15 The committee met'in open session, pursuant to 16 notice, at'2:05 p.m.,_Dr. Manual Cerqueira presiding.
17 18 . MEMBERS PRESENT:
-19 DR. MANUAL CERQUEIRA 20 MS. NEKITA HOBSON-21 MS. RUTH McBURNEY 22 DR. LOUIS WAGNER 23 .
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3 1 values the opinions of the committee very much.
L 2 r- I do request that whenever possible we try to
'3 reach a consensus on the various issues that we will discuss
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4 today or at any other ACMUI meetings, but I also do value 5 stated minority or dissenting opinions. I do ask that if 61- you have dissenting opinions that we read those into the 7L record, 8
.As part of the preparation for this meeting I have 9 reviewed the agenda for members and employment interests
- 10. ~ based upon the'very general nature of the discussion that we 11- are going to have today. I have not identified any items 12 that would pose a conflict. Therefore I see no need for an 13 individual member of the committee to recuse themselves from I 14 the discussion. However, if during the course of our 15 business you determine that you have some conflict, please 16- state it for the record and recuse yourself from that 17 particular' aspect of the discussion.
18 At-this point I would like to introduce those that 19 are here today and those that we expect..
20 First, we are expecting Niki Hobson, who is 21- representing patient rights, to join us.
22 Dennis Swanson is here, representing nuclear 23 . pharmacy. He is here as a consultant to the committee-24 because Dennis did go off the ACMUI on September 30, I
-25 'believe, but we are keeping him on as a consultant.
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4 1 Dr. Cerqueira, who is representing cardiology as
-2 well.as background and diagnostic nuclear medicine. He will 3 be functioning as the chair of the committee.
4: Dr. Don Cool, who is the director of the Division 5 of Industrial and. Medical Nuclear-Safety.
6 Ruth McBurney, who is representing state 7- interests.
8 Lou Wagner will be j oining us ' shortly, and he will 9 be representing'the physicists. I 10 I would like:to make two 'other introductions.
11 Barry Siegel is off to my right. Barry has been a 12 consultant to the Part 35 Working Group and has helped us
} L13 with revising the rule.
14 Theresa Kendall, who is sitting over to my left by 15 the pole, is providing administrative support to us. Also, 16 she is.the one that is handling your travel. If you need 17 anything associated with travel, you can see Theresa. 3
'18 With that, we will turn to Don.
19 DR. COOL: Thank you, Cathy. I am Don Cool, 20 director of the division. Let me add my welcome to you for 21 this afternoon's brief session.
22 As most you probably are both acutely and
.23 chronically 'now aware, we continue.with the re ision of,Part 24 3.5 . A good chunk of the agenda today-is in fact to look at 25 and be prepared to participate in the briefing of the ANN RILEY & ASSOCIATES, LTD.
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5 1 Commission that will take place tomorrow morning.
2 By way of background on that, the Commission has 3 had in front of it since August a draft final rule for their 4 consideration. They had requested the staff to provide the
-5 draft rulemaking language so that they could consider the 6 entire aspect of the rule. Not only the major issues, but 7 all of the bits and pieces to look at along with enough 8 supporting information to allow them to understand why the 9 staff had made the recommendations that it made.
10 They also asked that we provide them in a couple 11 of specific cases with some specific information, one 12 particularly beir.g in the patient notification arena as 13 result of some of their previous discussions. The package 14 which they have front of them, which is publicly available, 15 I hope each of you have had an opportunity to look at. That 16 package in fact contains two different alternatives of 17 possible rule text that the Commission will be'considering. ~
18 Tomorrow's briefing of the Commission will be the 19 public opportunity for the Commission to hear from the staff 20 and from the advisory committee about the revision of Part 21 35 in particular and any particular issues that you might 22 wish to bring to their attention.
23 I would expect that they will be very interes.ted 24 both in your particular views on a number of key issues and 25 may well ask'some rather pointed and focused questions to i
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1 try and help them understand the basis for particular 2 recommendations in support or changes that might be part of 3 that, because the Commission is in fact in the position 4 where following that meeting it is going to want to be 1 5 considering and voting upon that package in order to give 6 the staff direction on how to proceed.
7 The game plan for this is that the Commission will 8 complete its review with this public meeting and then any 9 further follow-up questions that they may ask of us and then 10 will provide the staff the staff requirements memo 11 indicating exactly how it wishes the staff to proceed with 12 finalizing the document. We would expect that they would 13 give us specific direction to change or modify specific rule 14 text.
15 Then we would be looking to provide back to the 16 Commission approximately three months after that direction 17 was given a final complete package, which at that point 18 would have any of the adjustments that the Commission wanted 19 to have to the rule language itself, to the supporting 20 documentation, as in the statement of considerations, 21 regulatory analysis supporting documents, as well as the 22 corresponding guidance document which has not yet been 23 provided so that we didn't spent too much time writing.a 24 document before the Commission was in fact comfortable with 25 how it wished the rule to look.
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7 1 That is where we are procedurally in terms of the 2 activities.
3 The Commission has a number of areas that we have 4 suggested to them that are of particular interest because 5 they have been the things that we have talked about and have 6 come up in the whole series of public interactions that we 7 have been going through over the last a little over two 8 years with this process. I think those are very familiar to 9 us.
10 Things like reporting levels for an unintended 11 dose to an embryo / fetus. The reporting of information to 12 the patient and to the Commission, whi h i' fact the 13 specific place where the Commission asked us to give them 14 some alternative language.
15 Training and experience, which has throughout this 16 process been an area of great discussion and back and forth.
17 So I would encourage you to use this afternoon to 18 look at those particular issues and to know how you would 19 tend to respond and which one of the committee members might 20 be the lead for that particular arena when the Commissioners 21 start to ask questions.
22 I expect tomorrow that there will be three 23 Commissioners at the table, Chairman Dicus and Commissi,oners 24 Merrifield and McGaffigan. Commission Dia: is out of town, 25 but, as they did today during the briefing by the ANN RILEY & ASSOCIATES, LTD.
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8 1 Organization of Agreement States, he will be listening by 2 phone. I don't know whether they by the time tomorrow comes 3 aro2nd have sorted out some of the technology glitches that 4 made it essentially impossible for Commissioner Diaz to 5 actually ask questions during the course of the discussion.
6 I hope they will have that fixed and that he will be able to 7 participate as well as just listen to the briefing.
8 The one other thing that I do want to mention is 9 that there was a briefing today by the Organization of 10 Agreement States. Dave Walter, who has been part of the 11 Part 35 Working Group throughout this process and the head .
12 of the Conference of Radiation Control Program Directors 13 State Reg Committee did make a presentation to the 14 Commission on that task group's view of the rule, and in 15 particular several places where that task group of the 16 conference is looking at some recommendation which does not 17 exactly match what is in the proposed final Part 35 that is 18 front of the Commission.
19 I know Ruth McBurney has had a copy of that talk 20 and the presentation that was made.
21 I should note that the discussion today did not 22 reveal any new information that I was aware of. The topics 23 which Mr. Walter discussed this morning in that public 24 meeting were essentially the same topics which he had 25 addressed during the Organization of Agreement States ANN RILEY & ASSOCIATES, LTD.
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h 9 1 meeting in Austin, Texas, a month and a half or so ago.
2 There were a number of questions asked by various 3 Commissioners in terms of the relationship between some of 4 the more prescriptive proposals which the conference task 5 group was considering and its interaction with the whole 6 concept of the practice of medicine. There was a little bit 7 of a discussion back and forth of what might constitute 8 practice of medicine.
9 There was some discussion on training and 10- experience. In particular some back forth with regards to 11 what data supports or doesn't support various segments of 12 the training and experience both in terms of the event 13 history that has been out there and the biological effects 14 of different quantities of material, particularly in the 15 unsealed therapy arena.
16 There was also some discussion on concepts of 17 patient release and some discussion on the reporting 18 criteria for the embryo / fetal dose, with Commissioners 19 asking a couple of clarifying questions and getting some 20 clarifying information.
21 In that respect, today's presentation paralleled 22 .in a number of ways the key issues that I expect to come out 23 and may well give an indication to you as members of th,e 24 committee of things that the Commissioners are likely to )
i 25 bring'back up to you and ask you very similar sorts of !
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1 10 1 questions to get the committee's view, and they are likely 2 also to ask the staff that same sort of question, trying to i
3 understand as bes'; they can before they vote the information 4 that goes behind this, the kinds of considerations that have 5 come into play, the facts and implications of the matter. I 6 think it was very clear that the Commission is concerned 7 about the implication for practice of medicine, for 8 availability of care as part of their overall consideration 9 of what to have in this rulemaking activity.
10 I think that concludes wh'at I wanted to outline 11 for you. With that, Dr. Cerqueira, I will conclude my 12 remarks and let you get on about the business of preparing 13 for the meeting. Thank you.
14 DR. CERQUEIRA: Thank you very much. I think for
-15 some of the issues that you have identified, especially if 16 the Agreement States have significant input, it will be very 17 worthwhile for Ruth to give us whatever information she can 18 recall from that meeting. The Agreement States right now, 19 there are 30 of them --
20 MS. McBURNEY: Thirty-one.
21 DR. CERQUEIRA: Thirty-one.
22 MS. McBURNEY: We just added one.
23 DR. CERQUEIRA: The federal rule, unless it has 24 wider application, may create some discrepancies and some 25 further problems.
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11 1 Cathy.
2 MS. HANEY: I would see we can just go on to the 3 first agenda topic and address this one so we can focus on 4 getting ready for the briefing.
5 This is the committee's self-evaluation. Let me 6 give you a little bit of background for those that have not 7 been with the committee for the last couple of years.
8 In 1998 the Commission came down with a request to 9 all the advisory committees asking them to come up with 10 self-evaluation criteria. We would always take about five 11 or ten minutes at one of the semiannual meetings and talk a 12 little bit about the criteria and where we were.
13 As a result of one of the meetings we did come up 14 with a list of criteria and that was forwarded up to the 15 Commission. You have a copy of that memo under your tab.
16 After that, Commissioner McGaffigan came back and 17 asked that we slightly modify two of the particular items 18 and add in, I believe, an additional question. That is the 19 list that you see in your book. You have a copy of what I 20 have up on the_ screen. It's a listing of all the questions.
21 The other advisory committee have gone back to the 22 Commission already with their self-evaluations. However,
- 23. because the ACMUI has been so involved with Part 35, we,went 24 back and said we've really focused in on 35 and that is why 25 we haven't gotten to you before, but the next meeting that ANN RILEY & ASSOCIATES, LTD.
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12 1 we have, which happens to be this meeting, we will discuss 2 it with the ACMUI members.
- 3. What I.would like to-do is work with the committee
- 4 to provide support to you all. If we can go through these 5- questions and come up with some answers to them rather than 6 spending time correcting them editorially, if we can get
.7 some thought processes down, some brainstorming down, then j 8 we can come back and refine this for you and then put it out 9 for the committee to look at as a,whole and maybe hold a 10 telephone conference call where you would actually get a 11 second chance to look at it. At this point we need to make 12 the next step, which is maybe to spend 20 or 30 minutes 13 going through some of these items.
14 The first one I would offer is, does the staff and 15 the ACMUI-interact in such a manner as to satisfactorily 16 address issues before~the Commission? Rather than me bias 17 you,' I will turn it back.
18 DR. CERQUEIRA: I can make my first comments.
19- Probably being the most junior member'of the committee, I _-
20- think the whole Part 35 revision rulemaking has involved an 21' extensive amount of interaction between the committee and
'the staff. I think we have provided a significant input in 23' terms of thA medical ~' applications and the clinical sett.ing, 24' which is expertise that the staff do not really have. I
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13 1 expertise'that have been-provided, and the mechanism for 2 this interaction has been satisfactory.
l 3 Perhaps we should go around and take comments, l 4 .perhaps starting with Lou who has been here a'while.
l 5 DR. WAGNER: I guess my only comment would be the 6
ACMUI has absolutely no inhibitions about interacting on any 7 issues that are brought before it. I have been pretty 8 satisfied with'being'able to address everything. I don't 9 have any qualms about this , issue.
10 'DR. CERQUEIRA: Ruth.
11 MS. McBURNEY: Since the draft comments are mostly 12- mine, I would say the staff has been very helpful in telling 13 us what issues need to be addressed and what the issues are, 14 what they want input on, and certainly with this volume of .
- 15. material that we are being asked to comment on on this i
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16 significant rulemaking there has been, as you say, a great 4 17 deal of involvement. That relationship with the staff has 18- 'been very positive.
19 DR. CERQUEIRA: Dennis.
20 MR. SWANSON: Yes.
21 DR. CERQUEIRA: Niki.
22- MS. HOBSON: Certainly the experience of 23 = interacting with the~ staff has been thoroughly enjoyabl.e for 24 me. This has been an education for me sitting in on these 1
25 meetings and hearing the learned discussions from both sides !
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14 1~ .of the table.
2 Sometimes I wonder -- and there is probably some 3- logical explanation -- when the committee takes a stand that 4 is not necessarily reflected in the staff's input to the 5 Commission. I am_ wondering why that happens. In particular 6 the patient notification issue. We have been pretty 7 unanimous in notLwanting patient notification, and yet we 8 keep seeing that issue come up. Are we not saying it strong 9- enough, or is there something else going on that I don't 10 quite' understand?
11 MS. HANEY: Can I address that? .
12 DR. CERQUEIRA: Yes, Cathy.
13 MS. HANEY: Your opinions are reflected in the
'14 minutes. We have the minutes after each one of the 15 meetings. Those minutes are provided to the Commission. It 16 happened to be that in this particular package they went up 17 with the rule-language. It doesn't always happen that way.
18' In fact, usually it goes up under a separate cover, but in 19 this one is_made sense to give it to them so they could see 20 -it first hand out of the minutes.
21 When we do a rulemaking, what leaves us is not 22 really what the ACMUI had recommended. We try at subsequent
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23' ACMUI meetings to come back and tell you what happened.,
24 That is a relatively new effort. The last two or three 25 syears before that I think there was a big gap on feedback to AlR7 RILEY & ASSOCIATES, LTD.
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-1 ;you. YouLmight not like what.we tell you when we come back and tell you, but. at least now you know why it happened.
2 3 But'the: minutes do go up.
4~ 'One, thing if I could get you to comment on. The 5 : bylaws right now call'for two meetings.
Last year we had l
6; .the ACMUI meetings,-but we did~ cancel the November meeting.
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7 'Because Lof - the Part 35, there.was no reason for you to.get 8; together.
9l Under:this;particular' item, .you.might want to 10- comment ont'he frequency..-of the meetings. Maybe additional 11 tsefofttelephone conferences. We did find out that if we do 12 .have a. telephone conference?whi'ch involves the' entire 113 committee and decisions are being made,.that'does need to be 14 made public. . We'need to.give a call-in line for.any of the 115 public that.would want to come in. So that would-affect how
- 16. Lwhether we would really want to go that way.
17 And use of e-mails. NRC is getting into all'this 18- JIT stuff. If you would want to comment on-how that would
- 19- help'or how'it does. help the committee.to adt.ress issues and 12 0 : ~whether-you feel like you are.getting enough information 21~ from.us. We could send you more e-mails if you want them, 22 3 : butt you might be-~getting enough of them already;.
- 21 DR. CERQUEIRA: . Cathy, I guess the Federal' ,
24' ' Advisory;; Committee'Act does. mandate'how some_of this
- 25 ' communication can be handled. I'm sure we have to stay KV ANN =RILEYE& ASSOCIATES, LTD.
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l 16 1 within those guidelines. I think some of these alternative
.2 methods would certainly be valuable as a way to get 3 information from the committee and feedback from the members 4 of the committee and staff. I think we would be willing to 5 explcre some of these possibilities.
6 I would like to make one comment about some of 7 Niki's stitement. We are an advisory committee. We can 8 feel very strongly about things, but there is no obligation 9 '
upon the staff or the NRC Commissioners to take action on 10 the recommendations. That's a little bit of a reality check 11 that I had to go through when I got here.
12 Would anybody else like to comment?
13 MR. SWANSON: Just a question, Cathy. Since it 14 seems like final decisions on a lot of these issues lie with 15 the Commission, how does the staff and the Commission 16 interact so that you have full understanding of where the 17 Commission is coming from on various issues such as patient 18 notification so that you can bring that back to this 19 committee?
20 MS. HANEY: I will answer it from personal 21 experience, and this is more less just a couple of years. I 1 1
22 feel especially with Part 35 that the Commission really does 23 have a good understanding for where the ACMUI is, because 24 I've had the opportunity to talk either with the j i
25 Commissioners directly or with their technical assistants on 1 ANN RILEY & ASSOCIATES, LTD.
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17 1 a one-on-one basis.. I have been quite honest with them 2 about where we stand, where staff is. Even within staff 3 there are differing opinions. Where the ACMUI is, where the 4 states are. I have tried to keep them informed of all the 5 different interests that are out there.
6 It was easy to do with a rulemaking like this that 7 has as much visibility as it has. On some of.the other 8 rulemakings we have done in the past on Part 35 they have 9 not been as visible. So it has really afforded someone in 10 my position the one-on-one contact with the TA's or with the 11 Commissioners-themselves.
12 What we try to do is in any of the Federal 13 Register notices we have to address that it was discussed in 14 an ACMUI meeting and this is what the ACMUI said. So it is 15 going to them in writing. I have no problems-with that.
16 Sometimes when you get the. opportunity to meet one-on-one 17 you can get a point across a lot better than you can by just -
18 reading.it in a draft Federal' Register notice.
19 MR. SWANSON: Do you feel as a staff member meet 20 with them enough to have a good understanding of where they 21 are coming from on this issue, Part 35?
22 MS. HANEY: On this one, yes. I think this one 23 has gotten e;.' ugh visibility and the way that it has be,en I
'24 I handled internally with a little bit more of a streamlining 25 process as,far as management. As any government agency, we ANN RILEY & ASSOCIATES, LTD.
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18 1 have our management chain. I haven't'had to go through as
';L ;many_of those steps with this rulemaking. That has helped a 3 . l i t t l e. b i t '.
4 Also, NRC asLa whole is going through a bit of a 5 change where we are looking more for stakeholder involvement 6 and stakeholder opinion and what are the implications on 7 .7: stakeholders. 'It is almost like everything is kind of 8- changing for the' good'at this point.
9 DR. CERQUEIRA: If we are going to finish'on time, 10 we probably should continue. Following Dr. Stitt's lead, 11 she was a very good taskmaster on time.
12 -We have enough information here in terms of the
'13 interactions between the staff and the committee.
.14 Question 2 of the self-evaluation criteria: Do 15 the committee members clearly define issues for staff and 16 provide timely, useful, objective information to the staff 17_ when requested?
18- This.is almost^a comment from the staff rather 19' .than the committee.
20~ MS. HANEY: We will get our opportunity to respond
. to these too.
22- DR. CERQUEIRA: Any comments on this, Lou.
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23 Dd. WAGNER: I think:the statement that is ma,de
.24 there is somewhat pejorative and should be struck. It tends 25 to indicate that people are biased. I think the whole idea
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a I here:is we have to represent different professions. The 2- whole. intent is to represent the different sides, and I 3- don't think'that should be presented in a pejorative way.
4 That is planned; that is the way it's supposed to be.
5 As far as I'm concerned, within my experience and 6 interactions that I've-had, the answer is~yes. I don't know 7- of any. cases where we'have not been able to communicate with 8- the staff well enough to provide objective information and i
9 clearly define the issues. I think the statement as it is 10 written is too pejorative and shoul'd be struck.
11 .DR . CERQUEIRA: Ruth.
12- MS., McBURNEY: It.really wasn't meant to be 13 pejorative. To be objective, you have to look beyond not-14 only the group that you are representing, but to try to
, 15 provide the most accurate information. I think the 16 committee members do try to do that.
17 DR. CERQUEIRA: I would like to comment that this 18- is a forum for input from various groups that are involved, 19 both physicians as well as physicists, radio chemists. I
'20. ,think the composition has been carefully thought out. We 21 obviously don't always agree on some of these issues and we 22- have.very strong opinions on them.
23 Certainly in the interactions that I have had 24 people have manrged a to put aside some of their real core 25 issues in a spirit of compromise to come up with a consensus l
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20 1 which has overall safety of patients in mind. Rather than 2 seeing this as a negative, I think it is a positive.
3 Dennis.
4 MR. SWANSON: The only comment I might make is I 5 think the committee does a good job defining issues in 6 response to items or regulations or proposed regulations 7 that are put in front of the committee. On. could also 8 interpret this to mean that the committee members themselves 9 are bringing issues to the NRC for discussion, and we I 10 probably haven't done that as much as perhaps we should be 11 doing it.
12 DR. CERQUEIRA: Good point.
13 Do you have sufficient information?
14 MS. HANEY: Maybe "the forum for providing 15 comments from different perspectives," and then I will 16 delete what is written there. Are you okay if I delete this 17 and then just go with those bullets?
18 DR. CERQUEIRA: I think that is fine. Question 6 19 also addresses some of this, all elements of the medical 20 community. I think we will revisit that again.
21 Does the staff have any comments for us? Are we 22 timely?
23 MS. HANEY: Yes, I think so. The experience has 24 really been with 35, and I think overything has run very 25 smoothly with 35. When we have needed you, you have been ANN RILEY & ASSOCIATES, LTD.
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21 1 there for us. I think the use of the subcommittees has been 2 wonderful. In fact, we got a tremendous amount out of the 3 subcommittees.
4 Also, I haven't had a problem in calling any one 5 of you and saying I've got this particular issue, you're the 6 best one to answer this, can you give me the advice, and 7 getting timely advice. When we go back with our staff 8 review of the interactions with the committee, that is what 9 I am going to emphasize.
10 I personally think there is a tremendous value to 11 this committee and my ability to access radio pharmacy, 12 physicists. Everyone always says, what does the patient 13 rights advocate say? They don't care what Dennis says, 14 It has been great. That's what I'm going to bring 15 up.
16 Are you okay-with number 3?
17 DR. CERQUEIRA: Any additional comments?
18 MS. HANEY: I would like to get your comments on 19 the subcommittees and whether this is a particular question 20 or not. Maybe we can put some bullets here, and then if 21 it's not, when we get to it, we can put it in another place.
22 Did you find the use of the subcommittees beneficial as 23 compared to just waiting and presenting the big bulk of the 24 material at a full meeting?
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22 1 addressed in number 9.
2 DR. CERQUEIRA: My experience on the committee has 3 all been related to Part 35 revisions and it has been very 4 intense, with frequent meetings and interactions.
5 DR. WAGNER: Are we addressing 9 now?
6 MS. HANEY: No. We can come to that. I didn't 7 realize the subcommittee was on there.
8 DR.-CERQUEIRA: Any additional comments on 3?
9 Let's move on to item 4. Does the committee 10 provide expert advice which is not available from within the 11 agency?
12 MS. HANEY': Let me' read it into the record. The 13 answer that we are looking at is:
14 Yes, the members of the committee represent those 15 being regulated as well as medical, physics, and 16 pharmaceutical expertise not available on the staff. It i
17 also provides input from the state regulatory perspective 18 which is to some extent different from that of NRC, and 19 input from radiation safety officers who must implement the 20 final rules and guidelines.
21 DR. CERQUEIRA: It's a very concise statement. I '
22 think it sort of summarizes some of the things we have said 23 earlier. ,
24 Does anyone wish to make changes or additions?
25- MR. SWANSON: The main point is you are getting
)
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l 23 1 input.from people that actually have to put your regulations 2' into practice, 3 DR. CERQUEIRA: The regulated community.
4 MS. HANEY: Question 5. Want to go ahead?
5 DR. CERQUEIRA: Sure.
6 MS. HANEY: Does the committee meet frequently 7 enough to address issues in a timely manner. The answer is 8 yes.
9 I would say if we could elaborate here. This is 10 really getting at what I was starting prematurely to talk 11 about. For right now semiannual is working, but looking 12 back to where we were last November, were you in agreement 13 with canceling that November meeting because of where we 14 were with the projects? To the best of my knowledge, that 15 was first time we had actually canceled one of the big 16 meetings. It didn't seem practical to have it.
17 Would like us to continue to consider that when we '
18 are having a meeting whether the timing is right and whether 19 there are sufficient issues to bring everyone together?
20 DR. CERQUEIRA: I think that is totally 21 appropriate. To just have a meeting for the sake of meeting 22 is not in anybody's interest. We spent all this time 23 working on the draft rule. I.think over the next sever,a1 24 years we are going to have to deal with the fallout of that, 25 and there may be more issues than we care to address.
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24 1 MS. McBURNEY: There are also those special topics 2 that we put aside until this rulemaking was finished.
3 DR. WAGNER: I would say that I think it is 4 important that this committee meet at least twice a year and 5 try to make every effort to d so.
6 I think last year and last November was an 7 exception, mainly due to the fact that'the staff was so S overwhelmed that organizing and putting together a 9 meaningful meeting was difficult. I think we should make 10 every effort to have a meeting twice a year to keep up to 11 date with what the issues and principles are. It's just 12 very important.
13 Whether we are going to address it or not, I also 14 like the issue of having subcommittee meetings in there, 15 because they seem to be extremely productive meetings where
'16 a lot of fresh ideas come forth.
17 I would not want us to get into a cavalier.
18 attitude toward having meetings. I think we absolutely 19 should have at least two a year.
20 DR. CERQUEIRA: Good points. If we don't have 21 enough issues, then you'd have to question the value of the 22 committee.
23 Ady additional comments for 5? ,
24 Cathy.
25 MS. HANEY: Number 6. Do committee members bring ANN RILEY & ASSOCIATES, LTD.
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25 1
issues from all elements of the medical community to the 2 attention of NRC staff. The answer that we are looking at:
3 Yes. Usually for those issues that involve other 4
aspects of the medical community consultants are brought in 5 for the committee meetings to provide expertise and 6 information for decision making in those areas. I was 7 pleased to see that a radiation safety officer. position has 8
been added to ACUUI since this position plays a key role in 9 !
implementation of rules and sees issues more clearly from a 10 radiation safety standpoint.
11 DR. WAGNER: Who is ";"?
12 MS. McBURNEY: That was the one person that 13 responded to this.
14 MS. HANEY: It wasn't me, Lou. I didn't write 15 these answers.
16 DR. CERQUEIRA: Any additional changes or 17 deletions?
18 MS. HANEY: Number 7. Does the committee 19 facilitate and foster communication between the public, 20 medical community and NRC?
21 Yes. This gives greater opportunity for the NRC 22 to listen to input from the public and the medical community 1
23 as well as for representatives of the medical community, to 24 better understand the regulatory philosophy that goes into 25 standards and policy, i
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b 26 1 DR. WAGNERi Isithis a question mostly answered by
.2 staffLabout the committee and rather than us.about 3 :ourselves?
'4 ,MS. HANEY No. This isireally for you~to look at 5 tyourse10est --Theiquestion is,-are you providing a link or a 16 .w ay.of getting information from your professional 7 .organi'zationsLtoEus?- And vi'ce versa. Are you able to'take
, 8 ~information that;you;getrfromibeing on this' committee.and go 9: :back tocyour professional organization and; help them to 10 understand why we.do things:the.way we do things.
a.
11: DR. WAGNER: We have to be very careful, though. .
12I As youLknow, we cannot speak as ACMUI members when we are 13- talking-to any of.those other groups. This question.is a 14 311ttle dicey'for me to get-into because of the way it is 15 . worded.and phrased. I would hope that our most important 16- role is to~give;the staff a perspective on regulation so 17
~
that its communication with other areas outside of the ACMUI 18- ,is more fluid and more communicative.
19 =- DR. CERQUEIRA: Dennis.
20 MR. SWANSON: It;goes the-other way too. I 21- ~ routinelyLdo presentations before the nuclear pharmacy
- 22. community as to where we' stand with the regulations, et l
23: cetera. So, yer it-is working the other way also. I, i
j clearly announce that I am not doing a representation as a a
- ' 24. !
1 25 member of the ACMUI. It.provides a mechanism to keep these I l
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27 1 people up to date, because obviously they are not in this 2 room.
3 DR. CERQUEIRA: I think the way the meetings have 4 been set up, if there are other interest groups that are out 5 there, they have the opportunity of making presentations and 6 presenting other viewpoints that may not necessarily be 7 directly. represented in the community. That option exists 8 out there to make certain we get communication from all the 9 parties.
10 Any additional comments for 7?
11 Why don't we go on to 8. I will read it while 12 Cathy is typing.
13 Does the committee consider current resource 14 constraints of the NRC when recommending new or enhanced 15 regulatory programs?
16 Yes, I feel that it does. One example this year 17 was the initial proposal for an exam to be included in the 18 training requirements for authorized users. The review of 19 exam programs would have been resource-intensive for NRC.
20 This was one of the reasons it was removed as a proposed 21 requirement. This measure was concurred in by the ACMUI.
22 Comments?
23 MR. SWANSON: To the same extent that the NRC 24 ~ considers resource constraints of the medical community when )
25 recommending new or enhanced regulations.
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28 1 You don't have to put that down.
2 MS. HANEY: I'll get it in there somewhere.
3 MR. SWANSON: In all reality, I think that is 4 something that is in the back of our mind that goes both 5 directions.
6 MS. McBURNEY: What's it going to cost the 7 community to implement and what's it going to cost the 8 regulators.
9 DR. CERQUEIRA: Other comments?
10 We can go on to number 9. Does the committee make 11 effective use of subcommittees to assist the staff on 12 specific tasks or projects?
13 Yes. I felt that the diagnostic and therapeutic 14 subcommittees were very effective in addressing issues 15 specific to those areas during the development of changes to 16 Part 35.
17 DR. WAGNER: I really like the subcommittee. Tney 18 1. ave been extremely productive. They are very intense and 19 well focused sessions. So I would encourage the further use 20 of subcommittees on issues, meeting between the staff and -
21 the ACMUI on these issues. It was great. It's terrific.
22 DR. CERQUEIRA: Lou, right now the breakdown as 23 sort of diagnostic and therapeutic, which was sort of a. j 24 risk-based pairing. Will this be the type of subcommittee I 25 that we would have in the future? What subcommittees do you ANN RILEY & ASSOCIATES, LTD.
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29 1 envision?
2 DR. WAGNER: I think that is an obvious breakdown.
3 Now since the focus is going to be more oriented toward 4 therapy there should be some focus on subcommittees within 5 therapy for different items and different issues. That will 6 break down and get some of these issues addressed and drawn 7 out.
i 8 DR. CERQUEIRA: Dennis.
9 MR. SWANSON: I think that question probably 10 should read, does the committee make effective use of 11 subcommittees and individual ACMUI members. Then you can 12 bring in your issue where you routinely call up people if 13 you have got specific questions.
14 I think we probably have made the most effective 15 use of subcommittees over the last two years, but prior.to 16 that there were things where individual members were brought 17 in as consultants. That is what I am trying to get back i
. i 18 into this because I think that has also been very effective.
19 DR. WAGNER: I think the most important point is 20 to state that the subcommittee use is a more effective and 21 efficient use of ACMUI committee members' time, and 22 hopefully it is also more effective use of NRC staff time.
23- That's a very important issue, because we don't have to, meet 24 as a' full committee and a few people can really intensely 25 get on with the issues. It certainly doesn't drag things ANN RILEY & ASSOCIATES, LTD.
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F 30 1 out in a full committee meeting and have things belabored 2 with discussion t!"' just never ends.
3 DR. CERQUEIRA: A very positive response for the 4 subcommittee program, and it is encouraged in the future.
5 MS. HANEY: One more.
6 DR. CERQUEIRA: Number 10. Does the scope and 7 size of the committee meet the current needs of the NRC?
8 Yes. I think the scope and size are appropriate.
9 I would hope that all positions can be filled in a timely 10 manner so that the level of expertise remains consistent.
11 Lou.
12 DR. WAGNER: This has been an issue since I've 13 been here and it has not been solved. I believe it is one 14 that should be addressed before the Commission. I am very 15 disappointed in the fact that there are lots of position; 16 that don't seem to get filled in an appropriate time when i
17 they are vacated. I don't know if we still have the l 18 radiation safety officer position officially filled. Is i 1
19 that filled?
20 MS. HANEY: No.
21 DR. WAGNER: Then we use nuclear medicine people 22 and other individuals who should be representing things and 23 we have thede large gaps at times with people not filli.ng 24 these positions. When we know a position is going to be 25 vacated, it should be announced well before it is vacated, ANN RILEY & ASSOCIATES, LTD. j Court Reporters !
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31 1- Land there should-be a. replacement coming in right after it's
~2 tvacated. The person who is going out should know who the 3 replacement is' going to be.
.4 LI don't know what the rules are with regard to all 5 these things, but it seems-to me that a more effective lead 6 time to get those positions filled promptly would make the
'8 efficient, because the subcommittee then would have a' full 9 ' staff. or complement of representation in order to get their 10 ' jobs'done.
11 This has been an' issue since I have been here. It 12- has'never gotten resolved, and I am still disappointed to 13 see how this.whole process is going.
14 LMS.'HANEY: Let me ask one thing that I would like 15 under this question for the committee to put something on-16' the record for. Last year when we went up.to the. Commission 7 with who.was on the membership, there were some positions 18- that were cut, one of them being a radiation oncologist
'19 ' position, which would take us down to one oncologist on the 20 committee.
21- We are'in the next' step of the process for filling 22' -some of these positions. It is a long administrative
-23 process;to get someone seated. ,
24' One of the-things.that we asked the Commission to
~
25' reconsider was having two oncologists back on the committee.
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32 1- The rationale that Sna gave for that was that the oncology 2 profession is so diverse. Basically, we said it is very 3 <hard to find one person that'can address everything.
4 I guess I would like your comments on whether you 5 agree with that.
6 DR. WAGNER: Are you saying that Judy Stitt's and 7 Dr. Flynn's positions be combined into one?
8 MS. HANEY: Last year they were combined to one.
9 However, we have gone back to the Commission from a staff 10 level saying that we would like two positions. Actually, 11 Dr. Flynn had also written a letter to Chairman Jackson at .
12 -that point saying that it was not wise to do that.
- Some of 13 the. reasons that I just gave you'is what Dr. Flynn had 14 given.
15 Since we have got this topic before us, if they
-16 decide to against that, I could also say in the October 1999 17 meeting the committee reinforced the need for two 18 oncologists cn1 the committee. I don't want to put words in 19 your mouth, but - if you"would like to say that.
20 DR. WAGNER: Absolutely. The facts are you are 21' -looking'at risk, and'that is where the risk is. That is 22- where the-doses are delivered; that is where the radiation 23 levels are high. There is where you have such a wide ,
24 ' variety, and it is expanding in its scope in terms of 25 applications. There is no way in the world you can have ANN RILEY & ASSOCIATES, LTD.
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33 1 representation from one person who knows it all. That's 2 impossible.
- 3. I think that two people is absolutely essential to 4 the proper function of this committee from that standpoint.
5 That is the biggest area that really needs representation 6 from the medical community.
7 MS. HANEY: Thank you.
8 DR. CERQUEIRA: Right.
9 MS. McBURNEY: I agree with that. With all the 10 things that we are going to need to be addressing at least 11 in the near future on the emerging technologies, the labeled 12 antibodies, intravascular brachytherapy, and so forth, there 13 is probably not a single oncologist that is doing a lot of 14 all of that, plus teletherapy as well as the
- 15. radiopharmaceutical therapy and so forth.
16' MS. HANEY: There is definitely one oncologist.
17 If the Commission goes the preferred route, there would be 18 two encologists, the radio pharmacist position, the 19 radiation safety officer. The research position was one of 20 the ones that was cut last year by the Commission. I have a 21 paper upstairs, but off the top of my head that's it.
1 j
22 Dr. Alzeraki is still on the committee. She l
23 unfortunately had jury duty, so she could not come today. .
24 So we do have diagnostic represented. They are just not 25 here today. And John Graham is also still on the committee ANN RILEY & ASSOCIATES, LTD.
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34
, 11 but because of death of one of'his supervisors there were 2 some responsibilities he needed to pick up.
3 JohnLis here for another year. Lou, you are here 4 for two more. Does that sound right?
5 DR. WAGNER': I thought it'was one,.but maybe it is
-61 'tw'o.
7L MS. HANEY: I think you are two, because I think 8.. we renewed you.
9 DR. WAGNER: If you can put with me for another 10' year. ,
'11 MS. HANEY: Sure. You're going to help me
-12 implement this rule. As long as we can continue to argue 13 the 5,000 millirem reporting threshold I need you around.
14 'DR. CERQUEIRA: .Those are some very good points 15 I guess one of the things that does come up is how wide a 16 group do you need. Talking about the radiation oncology, 17 with.the emerging technologies some of the cardiology.
18 community feel somewhat under represented in the sense.that 19 we have sort.of a diagnostic cardiologist, but as that 20 representative I am certainly not an expert in any way in
-21 intravascular brachytherapy. So there is'some expertise 22: within the cardiology community that is not represented, and 23 I certainly don't. quality to represent.
24 You can't every opinion, but at the same time if 25 this is going to be.an-important: area in the future, then~I ANN RILEY & ASSOCIATES, LTD, Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 Washington,.D.C. 20036 -
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35 1 think that consideration should be given as well.
2 MS. HANEY: We always have the option of ..nviting 3 someone to the meetings. I would just say that when you do 4 see the agendas coming out, if you think there is someone 5 that we do need to invite, if you can give us feedback, we 6 can do it. I think we are going to get to the point we are 7 going to need to bring in some of the cardiologists that are 8 working in the therapy area to sit in as an invited guest.
9 That is probably going to be an obvious one, because I think 10 we will be dealing with T&E issues for them soon.
11 If there a particular meeting that you think we 12 should invite somebody, please let us know. We can do that.
13 We've never had a problem with bringing in an invited guest.
14 What we will do is take these and refine them a 15 little bit just to help you out some. Then we will send it 16 back out to you. If you want to change it, feel free to 17 change it. My intent is not to put words in your mouth. If 18 you don't like what you see, make sure you tell us.
19 DR. CERQUEIRA: Cathy, this is not going to be 20 presented to the Commissioners tomorrow; is that correct?
- 21. MS. HANEY: No. l 22 DR. CERQUEIRA: This is sort of an ongoing 23 process. ,
24 MS. HANEY: This is a separate action.
25 DR. CERQUEIRA: I think it might be a good idea to j l
l I
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36 1 send it out to people. For some people this is first time 2 they have seen this, and it might be worthwhile for them. I 3 am sure that people will add specific comments and input.
4 MS. HANEY: Even on your flight back, if something 5 comes to mind and there is more information, just send me an 6 e-mail and we can incorporate it right away.
7 MS. HOBSON: Can I just make one comment?
8 DR. CERQUEIRA: Sure.
9 MS. HOLSON: Earlier you were talking about using 10 e-mail and conference calls, and I think that is a great 11 idea. I have benefited greatly from the face-to-face 12 meetings and hearing the interaction between the committee 13 members and among the committee members, because each of you 14 come from an area of expertise that I don't know about. So 15 it's really very beneficial to me to hear all this 16 discussion. Conference calls are fine as long as everybody 17 is hooked up and I can eavesdrop in on these conversations.
18 But one-way e-mails would not be real beneficial to me.
19 MS. McBURNEY: You don't have the group dynamics.
20 DR. WAGNER: All e-mail should be copied to 21 everybody on these communications.
22 MS. HANEY: I think we are doing that. I hope we 23 are doing it. 1 24 DR. WAGNER: I think it is.
25 MS. HOBSON: As long as I get everybody's input. )
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37 1 DR. WAGNER: There shouldn't be any private 2 conversation going on with these kind of issues.
3 MS. HOBSON: .I need it probably the most of 4 anyone.
5 DR. CERQUEIRA: I was.just appointed to this HCFA 6 committee which is now under the Federal Advisory Committee 7 Act, which has very strict rules. I don't think you are 8 ' allowed to have conference calls because it constitutes a 9 public meeting without public access.
10 MS. HANEY: We did check into that. Like the 11 meeting we had where we had a couple of members. We went 12 through our lawyers. My understanding was that we could do 13 a meeting by phone except it would have to be noticed as a 14 public meeting and the phone lines would need to be made 15' available to the public to call in. That would be a meeting 16 where we were making decisions. Just an informal one-on-one 17 or.two-on-one where it is almost like scoping early things 18 like --
19 DR. CERQUEIRA: Does it require a Federal Register 20 notice?
21 MS.-HANEY: Diane, was it Federal Register or just 22 a public meeting notice?
23 MS, FLACK: I'm not sure about that. But you have 24 to provide a room that people can go to..
25 MS. HANEY: I don't think we will go that way.
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1
38 1 That would.almost be if there was something we needed an 2 answer on in two weeks and we knew we couldn't bring you in.
3 My intent is not to go to that. I agree with Niki. There 4 is a big benefit of sitting around a table and talking about 5 i t ..
6 MR. SWANSON: I think it goes beyond that. I 7 think there is probably something to be said for body 8 language.
9 [ Laughter.]
10 MR. SWANSON: For example, Office of Protection 11 from Research Risk for IRB activities mandate that if you 12 have a local research context, which means that if you are 13 doing research someplace else, you have to have a 14 representative from someplace else. They will only allow 15 video conferencing. They will not allow telephone 16 conferencing because they believe there is something to be 17 said about body language. In reality, there probably is 18 something to be said about body language.
19 DR. WAGNER: What am I saying right now?
20 MR. SWANSON: I know what you are saying all the 21 time.
22 DR. CERQUEIRA: Let's take a five-minute break.
23 (Recess.]
24 DR. CERQUEIRA: I would like to welcome everybody 25 back for the start of the next session, which is going to be ANN RILEY & ASSOCIATES, LTD.
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39 l
1 .the preparation for the' October.21 Commission briefing on 2 the revision of Part 35, Medical Use of Byproduct MateLial.
3; Cathy andLDiane have provided some overheads which 4- are-under Part 35'Vugraphs, ACMUI.
5 MS.'HANEY: These viewgraphs have already gone to
- 6 the Commission. So1we really don't have the option of
- 7. changing the text. We.could change it if we absolutely.had 8 t o ,' but my recommendation is not to.
9 DR. WAGNER: Cathy, we' meet tomorrow at 2:00'with 10
~
the Commission; is that correct?.
11 MS. HANEY: No, at 9:30. It's on the One White 12 Flint building,.the other building, on the first floor. If
- 13. you just come in and say you are going to the Commission 14 hearing room, there'are there. Be there before 9:30, 15 because they do start promptly at 9:30.
16 The format.is that I will do a half hour
'17 presentation. Then they will ask me questions or drill me 18 for 30 minutes. Then you guys will switch seats. You will 19 ~come up to the table. I would plan for a half' hour 20: presentation, no more than that. Then you get drilled for a j 21- half hour.
22 . Chairman Dicus is trying very hard to stick to 23' . schedule. The other thing that she is trying to do is ,to 24- let'the -individuals go'through the entire presentation ;
- 25. before'asking questions. If you remember from previous ANN RILEY'& ASSOCIATES, LTD.
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40 1 ones, the tend to jump in. But any thing is open. That is 2 what they are trying for.
3 You should have copies of my viewgraphs, the ones 4 that I will be using.
5 DR. CERQUEIRA: Cathy, do you want to go over 6 yours and then go to ours?
7 MS. HANEY: I can.
8 DR. CERQUEIRA: What we should try to do with 9- today's meeting is go over ,the specific material that we 10 want to cover, but also to assign somebody from the 11 committee that will be making the presentations.
12 DR. WAGNER: Could you brief us quickly about the 13 composition of the Commission as it stands today?
14 MS. HANEY: Right now Greta Dicus is still 15 chairman. She will be chairman until next Friday. Next 16 Friday we will get a new chairman. I think Dick-is his 17 first name. Dick Moserve will become the new chairman.
18 Tomorrow you will just have Chairman Dicus. You 19 will have Commissioner McGaffigan, who you have met with 20 before. Commissioner Merrifield, who when you briefed him 21 in March last year -- he'll be off on your right -- this was 22 the first time he had heard anything about medical.
23 That will be it sitting at the table tomorrow. .
24 Commissioner Dia: is not here. They did try to tie him in 25 by a phone line to a briefing this morning and it didn't ANN RILEY & ASSOCIATES, LTD.
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-li work real well. 'So they are.probably going _to try it again.
2 You may hear this voice,.and that's Commissioner Diaz, You 3 have-met with'him also. So until next Friday we are with a 4- .four-person Commission.
5- DR. WAGNER:
It keeps changing.
6- MS. HANEY: It does. Once Chairman Jackson left 7 we needed a. chairman. We can't have an acting chairman.
8 LThat's.why they moved'Dicus in. Now we have the new one.
9 It keeps us on our toes.
10- What I:could do is,go_briefly through'what I'm 11' going to.say, and.I'm'_ going to tell.you'some places where I 12' think maybe you could help _and some comments that you might 13 want'to add. WhenLwe get to that specific area on your 14 Lviewgraphs,'you will have an idea of where we.are going.
15 Page 1 is just the briefing outline.
,16 DR. CERQUEIRA: This'under the'Part 35 viewgraphs
'17 for staff, which is the last tab.
18 MS. HANEY: Ifam not going to go much into the 19 background because of the time, and they have heard a lot of
- 20. before,-but I will be stressing continuous interaction. You 21 may want-toLeomment on the interaction that you know of that i
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22 has taken place and how effective that has been.
, 23 : Thentjust the purpose of the SECY paper, whic.h.is I 24 that four inches of paperwork that we mailed you.
25- _ Key issues for Commission consideration. The idea i e i l
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42 1 .here is, these are the' big ones that we are bringing to you, 2 Commission. At the same time there are probably about 300 3' other little ones that are in this package, but I don't have 4 enough time to go through all of those issues with you.
5 These are.here because either they were concerns 6- of the Commission where :they asked us specific questions, or 1
7 theylwere concerns.of the stakeholders that I thought really 8 needed to come to their attention-in this sort of this 9 meeting.
10 The'first thing that we-discuss on page 5 is the 11 need for a' formal risk assessment. The Commission had asked 12 us to come back with the pros and cons of doing a formal 13 risk assessment. I will be emphasizing here that the rule 14 'is risk informed, that we have made significant reductions 15 in the unnecessary regulatory burden in the diagnostic area; 16 ~there there are still some prescriptive requirements for the 17' therapy, but we believe that is warranted by risk.
18- Page 6 is the Radiation Safety Committee. I will 19 be explaining that the comments were fairly well split on 20 the Radiation Safety Committee. Health physicists, radiation 21 safety officers tended to believe that the committee should 22 not be deleted at all. Hospital administrators, physicians 23- did not necessarily see the need for the committee and. felt
.24' 'thatLit was better to give the licensee the flexibility on
'25 how to manage their program. I ANN RILEY & ASSOCIATES, LTD.
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. .n 43 1
We took a risk-based approach in developing the 2 draft final rule.
We went ahead for the sake of the slide 3 and used the subparts. Subpart E would be your unsealed 4 therapies; subpart F in your manual brachytherapy; and H is 5 your therapy devices. If you have two or more in that area, 6 you would need to have a radiation safety committee.
7 .The other condition is that if you have two or 8 more types of units under subpart H, like if you have a 9
remote after-loader in a gamma radiosterectactic unit, you 10 would need a radiation safety committee. The idea here is 11 that we would bringing the different disciplines together to 12 discuss issues.
13 Viewgraph 7 is your training and experience l 14 requirements. I need to focus here on the fact of why we l
l 15 are no longer going with approval of training programs, 16 because in March I wac pitching no exam, we'll approve 17 training programs. We have evolved from there to the point 18 where we don't think we should get into the approval of l 19 training progr ms. Rather, we are going to be relying on l
20 the preceptor to certify that the individual is competent to 21 function in their particular position, whether it's a 22 radiation safety officer or an authorized user.
23 We did increase the hours in some areas over the 24 proposed rule, especially in the diagnostic areas.
25 DR. CERQUEIRA: One point here. On page 8, the ANN RILEY & ASSOCIATES, LTD.
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44 1 CRCPD committee concerns, are ' ou going to bring up some of 2 the issues? I guess the Commissioners met with the 3 Agreement States.
4 MS. EANEY: Right. This would be one area where I 5 would identify ~the fact that, Commission, I'm aware that you
'6 heard yesterday that there were some differences, but in 7 this particular area there was a difference, the SR-6 8 Committee believing that the training and experience for use 9 of I-131 should be higher than what is in the draft final 10 rule.
13 The kick-outs here in the rule the use of I-131 .
12 are almost specific to the endocrinologists. I would 13 mention that the track record of use of I-131 by 14 endocrinologists has been very good, and that because of 15 that, we could not justify an increase in the hours.
16 However, we did increase the hours in the 35.300 area, which 17 is the unsealed byproduct material, because that section is 18 not just limited to I-131 use.
19 That was the argument probably a year and a ago 20 that Dr. Flynn~made about some of the pharmaceuticals that 21 are being used under 35.300 can get into bone marrow 22 suppression, and the risk is higher. Therefore we increased 23 the hours there.
24 DR. CERQUEIRA: I guess the one comment I would 25 like to make is with 31 Agreement States just in terms of ANN RILEY & ASSOCIATEE, LTD.
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I i 45 1 training people who don't come in through boards, it would l 2 be very important to have uniform federal policy at least l 3 for the diagnostic.
4 MS. HANEY: You have got some viewgraphs that are 5 specific to training. That'is the area _where you probably 6 want to bring that up.
7 DR. CERQUEIRA: Does the staff support this?
8 MS. HANEY: That is a tricky question. I guess I )
9 personally don't disagree with you. However, when we take a !
10 rule and we decide what level of adequacy or compatibility 11 should be assigned to the rule, there stepping stones that 12 we go through, and we call it a management directive. Using )
13 that management directive is how we arrive at the 14 compatibility. Training came out at a C.
15 In order to get it to a point where the states 16- would have the same requirements, we have to either say it 17 is equivalent to Part 20 sort of issue, a dose limit or 18 definition. The only other one that would kick it out 19 higher is if we could say this is a matter of interstate 20 . commerce. I don't think we can argue on that.
21 Then you go to the next tier, which is where you 22 are right now, that the states have to have the option of 23 being more' restrictive if they want to.
24 So this is a matter not so much with Part 35. The 25 issue is with the adequacy and compatibility policies that ANN RILEY & ASSOCIATES, LTD, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
46 1 we use.
2 The Commissioners are awere that this is an issue.
3 This is getting back to what Dennis had said. This is one 4 of those ones I have talked with them about, and their 5 technical assistants know. I think you should use this as 6- your opportunity for you to make that pitch about the 7 differences. Even this morning Commissioner McGaffigan 8 questioned Dave on the I-131 training and said you may be 9 fighting this on 31 fronts or 32 fronts as compared to just 10 with NRC.
11 I don't want to say that they are happy where we 12 are, but I haven't heard that they aren't. Again, the 13 states have the option of being more restrictive on this.
14- So they are aware of this issue.
15 DR. CERQUEIRA: I think if this were a category B 16 instead of a category C, it would certainly be greater 17 simplification for people that are out there.
18 Dr. Siegel is expressing some body language. l I
19 Barry, do you have any comments?
20 DR. SIEGEL: Only that states have different 21 medical licensure requirements. I don't see how you could 22 ram one down their throats. The Constitution didn't give 23 this particular power to the federal government.
24 DR. CERQUEIRA: Good point.
25 Ruth.
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l 47 1 MS. McBURNEY: That's true. The comments made by 2 Mr. Walters were those representing the Suggested State 3 Regulations Committee. It did not represent the whole l 4 Organization of Agreement States' position. They have not 5 taken a position. The states have not had an opportunity to 6 review those suggested state regulations. You couldn't do a 7 brush that all the states are going to want to go that way.
8 Would this be a good opportunity for me to clarify L 9 something from the minutes of the last briefing? I was 10 quoted as being an endocrinologist and having to do with the 11 training and experience on that. Apparently that was not my 12 quote. It was someone else. I'm certainly not an 13 endocrinologist.
14 I would concur on the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> being adequate for ,
i 15 an endocrinologist for the single isotope that they use.
)
16 DR. CERQUEIRA: We will have an opportunity to 17 bring up some of these issues. It would be helpful if the 18 staff also could anticipate some of the things we are going 19 to say.
20 MS. HANEY: Number 9 is the threshold for the 21- unintended exposure to embryo / fetus / nursing child. In the
{
22 paper we have recommended that the rule have a 50 23 millisievert threshold for reporting. There are those that l 24 are still arguing the 500. I would say this is an area 25 where I think you guys really need to get some technical 1
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48 1 facts on the table about the effects of the difference 1 2 between 500 and 5,000 millirem exposure on an embryo, fetus
~
3- or a nursing child.
l 4 We have a backup slide that references some AAPM 5 and NCRP information. It's on page 25. What I would like 6 to have happen tomorrow, if I get the more technical 7 questions directed to me about the statistics, the 8 ~ percentages, what effects you see, I'm going to defer to the 9 ACMUI. Back in the March meeting, Lou, you did the 10 presentation, and it was wonderful. I think even though 11 it's almost a repeat of some of the things you said back in 12 March, we might want to consider that type of presentation 13 again.
14 This is one where what you are fighting against is 15 good rems and bad rems. NRC is in constant discussion with 16 EPA over whether dose limits at Yucca Mountain should be 15 17 millirem or 25. millirem, and, Cathy, you're saying embryo /
18 fetus can get 5,000 millirem. Does you see'a problem here, 19 Cathy?
20 That is some of the perspective of where these 21 comments are coming from. Then you look at the Part 20 22 limits where the public dose limit is 100 millirem and the 23 limit to dedlared pregnant women is 500. It is like, why 24 are you such an' order of magnitude off?
25 This is what you are working against or with.
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. : .m 49 1
The next one is the notification following a 2 medical event or exposure. After the March briefing when we 3 received the SRM, the Commission asked us to come back with 4 an alternative rule language. That alternative rule 5 language would only have the licensee certifying to us that 6 the patient or responsible relative was notified.
7 I have pointed out that the committee has voted 8 against any notification. I think that is one of the items j 9 in your viewgraphs. Howeve,r, I think you might want to 10 consider how much do you want to support this.
11 It is kind of like if I can't have exactly what I 12 want, is this one step better? Is this one step in the I 13 right direction?
14 All the Commissioners have different views or) this 15 particular item and some feel stronger than others.
16 The additional CRCPD SR-6 Committee concerns have 17 to do with the criteria for release of individuals 18 .containing -- well, 35.75. There are two things here. One 19 is they would like the authorized user to sign the record of 20 the release.
1 21 The other thing is they would like a statement in 22 the rules that says that once the patient is released, goes i 23 home, if contaminated material triggers a landfill moni. tor 24 they want a statement in the rule that says the state could 25 still hold the licensee responsible for that material.
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50 1 From NRC's standpoint -- I am not sure of the 2 legal situation with this -- if you have made a release in 3 accordance with our regulations, how can you go back and say
~
4 that it was not an adequate release?
5 In this area the states can be more restrictive.
6 This may be just one of those situations were we back off 7 and say, states, you can be more restrictive, but we are not 8 going to go there because you don't see this in our rule.
9 The other particular item has to do with 10- brachytherapy treatments. We have in our rule that you can 11 house or quarter two patients together that have had .
12 unsealed therapy, and you can house two together that have 13 manual brachytherapy. The states will probably not 14 authorize two unsealed patients being in the same room. Our 15 position is that the dose that one is receiving from the 16 other is inconsequential in light of the amount of that they 17 are receiving from their particular treatment.
18 DR. CERQUEIRA: Cathy, one question about the 19 release and the releasing institution being held liable. Is 20 this a safety issue or a financial issue from the states?
21 MS. HANEY: I think you will hear both arguments.
22 It's obviously financial, because it's the states that have 23 to go out to the landfills. When the alarm goes off, t. hey 24 have to go out. In some cases is tech waste; in some cases 25 iodine waste, but you might find that manual brachytherapy ANN RILEY & ASSOCIATES, LTD.
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e .- .m 51 1 seed that is out there too.that a facility has lost. So 2 they need to go out and check. Then you ha"a got the state 3 physicists'out there going through garbage at the landfills.
4 It is a financial, it is resource drain.
5 Then there are those that will argue that it is a 6 safety issue. In the early 1990s when the ACMUI discussed 7 this rule, it was, is the patient the leaky source? The 8 documentation we used to support the rulemaking was that the 9 patient was not a leaking source and that if the licensee 10 considered the maximally exposed individuals, any doses that 11 anyone other than that received would be well below that 12 limit.
13 DR. CERQUEIRA: Is there a consistency within the 14 states at what level of activity these systems are 15 triggered? Is it possible that they are set too low?
16 MS. McBURNEY: There is not a real consistency 17 now. There has been some guidance put out by the Conference 18 of Radiation Control Program Directors. Landfill operators 19 can set levels on their own.
20 DR. CERQUEIRA: My concern is if you are going to 21 hold these hospitals liable for non-dangerous levels of 22 radiation, that is a fairly hugh liability for the cleanup 23 if there is no safety issue involved. If you have adequate 24 thresholds for detecting dangerous radiation levels, then I 25 think that would be appropriate. Otherwise these ANN RILEY & ASSOCIATES, LTD.
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E '
52 1 institutions are going to assume Aarge liabilities without 2 any' safety risk to the users or-the public. I'm not sure we 3 want to necessarily. impose that.
4 DR. WAGNER: I'm very confused about this issue.
5, I don't understand the points that you brought.-up in regard 6' to this. I don't know if-thic is the time to talk about
!7 this or not. It seems to me.that the issue of trying to 8 make.a user responsible forfa legally. released substance is 9 silly.
10 _The problem is that you have to be able to 11 distinguish for the landfills what1is a source that needs to 12 be investigated and what isn't a source that needs to be 13 investigated. That needs to be solved. That is the issue 14 that needs to be solved. We don't solve this from a 15 regulatory point of view, trying to throw the responsibility 16 back.on the user who legally released the patient. That's 17 silly.
_18 ; MS. HANEY: That's why we differ in this area, 19 'because we did not put a-corresponding requirement. If we 20 get into this tomorrow, hopefully the representative from 21- our legal counser_will be there to address the legal aspect 22 of it_as compared to the safety aspect of it. This is one 23 of those issues where you may have to fight on a ,
24L state-by-state level as compared with NRC.
25 DR. SIEGEL: Just a question, Cathy. The ANN RILEY & ASSOCIATES, LTD.
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.w 53 1 underlying regulations that are causing this problem are EPA 2- regulations that preclude disposal of radioactive materials 3 in these' landfills?
4 MS. HANEY: I don't-know if it's an EPA regulation i 5 -per se, but I.know.that the states do have regulations that l 6 !say no. radioactive material in-the regular sanitary 7 landfills. .Therefore, the alarms are being set very low to 8 catch it, and as soon as the alarm goes off, then you have 9 to respond to it.
10 MS. McBURNEY: Cathy, we are one state that allows
'11- certain levels of short-lived isotopes to go to the sanitary 12 landfills. Certainly we have this problem of the detectors 13 ' going off. 'A lot'of times it's material that is being 14- allowed to.go there. Not only from released patients, but 15 also material from hospitals that we under regulation have 16 allowed.
1
- 17. They have to set those detectors low enough so
- 1 4
{
18 schat they would pick up-like a sealed source in.a. big 19 truckload of material. -That is what we don't want to get in 1
20- there. So.we have-to accept that there are going to be hits 21' on those' detectors for other material as well.
22~ DR. CERQUEIRA: Dennis.
23 MR. SWANSON: I doesn't make any sense to me., You 24 .are not concerned about us flushing all the stuff down the 25 sewer?
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54
- 1. MS. McBURNEY: That's not the point. We tell them
'2 to put it down in there if that's what it is, but we have to L3 respond not knowing what it is and where it came from.
.4~ . DR . WAGNER: There has got to be a technical 5 solution to this.
6' MS. HANEY: From 35's standpoint it's a non-issue.
' 7J It's not '
non-issue'for any of the regulators across the 8 . board.
9 Let me tell you about 15. The emphasis here is 10 going to be that-we are going to continue to use a specific license for Part 35 licensees. de have made a significant 12 reduction in the amount of material that needs to come in in
- 13. support of a license application. There have been those 14 that have commented and said, fine,-you're not going to look 15 at it at the tir an you license someone, but you are 16 going to get into a detailed review of procedures at the 17 time of inspection. The answer to.that is, no, we are'not 18 going to go into detailed. review of procedures at the time 19 of inspection unless'it is warranted. For example, like we 20 are going up to follow up on a medical event.
21 Then we only expect minimal changes to the 22- enforcement policy, mostly because of changes in terminology
-23 and some c' the thresholds in there. The whole issue of 2'4 ' what 'fus ' going on with the enforcement policy is a sepa; }
25 effect. 3 ANN RILEY & ASSOCIATES, LTD.
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!. 55 1 Page 16. The estimate is 3 FTE to complete the 2 rulemaking, medical policy statement and the NUREG, which is 3 the' guidance date. As far as our best guess of what we are 4 looking.at when we would finished, if we get a staff 5 requirements memorandum in November, we will have three to 6 four' months to finish everything we need to finish. Then 7- OMB has 90. days to give us-an OMB approval for any of the 8 recordkeeping requirements. We would probably publish'in 9 the Federal-Register mid-2000 with an effective date of six l 10 months out.
11 There are a' couple backup slides here that if'you 12 want to reference or use, you are always welcome to.
13 .The first five pages is just a chart where we went 14 through to show what regulations applied to what type of use 15 in the unsealed material area. On the first page it looks 16 like there are a lot of checks there. You have the purpose 17 'and the scope section, the definition section. Most of this
- 18. .:Ls just your paperwork sort of stuff. There really aren't 19 rny requirements.there.
20 As you get into subpart B, the first couple set up 21 a radiation safety program and supervision, and then you 22 _have the training issues at the end.
.23 It isn't until you really hit subpart C that you 24- are.looking at the requirements that really cause'the 25- ; licensee-to do something in their day-to-day operation.
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.1- .The take home message here is that in the 2 diagnostic area, the 35.200, while thev do teve the 3 . requirements.to comply with others in the general nature, 4 there really are very few requirements in the diagnostic 5 area, 6 Page 23 is just the training ano experience 7 requirements that are in.the draft final rule. That is two 8 pages.
9 Then we have a little bit of backup on the 10 recommendations for the exposure' to the embryo, fetus and I
' 11 - nursing child. If they want to go more into a projected .
12 schedule,.this is more detailed.
13 The last two pages are something that should have 141 been in front of you when you sat down. This is something 15 that the specific Commissioners had asked that we 16 incorporate, This is a comparison of what the draft final 17 rule says and the' current Part 35. You can go down and see i 18- where the differences are. ;
19 Page 28 isithe alternative rule text that we put
-20 . forward for the report notification of the medical event.
21 This is1gets into if you-would only be requiring 22 certification versus getting more detailed and getting into 23- the reports that are required. .
24 That is my spiel tomorrow.
25 DR. CERQUEIRA: Any. questions for Cathy on any of ANN RILEY & ASSOCIATES, LTD.
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57 1 this?
2 Barry.
3 DR. SIEGEL: This certification for medical event, 4 was it proposed that that also apply to the pregnancy breast 5 feeding as well?
6 MS. HANEY: Yes.
I 7 DR. SIEGEL: Then the question for Dr. Cerqueira 8 is whether the committee ever actually officially voted to );
9 endorse that as a better than nothing alternative. The l 10 committee is on record as saying no notification is what we 11 think is appropriate because it is already being done and 12 you don't need a federal rule.
13 DR. WAGNER: No regulation for notification.
14 DR. SIEGEL: I think Cathy asked the question J l
15 earlier whether the committee would want to take a stand on 16 this as an alternative if you can't have exactly things the 17 way you wished them to be. This might be better than the l 18 current language.
19 MS. HANEY: Page 7 says that. We can always talk 20 around things if we have to. If we have to change a 21 viewgraph, we can change it.
-22 I think if you aren't prepar to discuss it, you 23 will get asked, what are your views on the alternative , rule 24 text?
25 DR. SIEGEL: Actually, the question I was asking i
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58 1 was, has the committee ever actually voted on that?
2 MS. McBURNEY: I don't think we have met since 3 then.
4 MS. HANEY: No, they haven't met since then.
5 DR. SIEGEL: I am sort of suggesting you might 6 wish to.
7 DR. CERQUEIRA: Deunis.
8 MR. SNANSON: I think if you look at our viewgraph 9 on this, it says ACMUI does not support any regulation 10 ' requiring notification of physicians and patients as this is 11 redundant to existing standards of care.
12 Then it has on here " alternative rule language 13 provided by staff preferred over existing requirements."
14 So your viewgraph sort of does comment on that or 15 leave it open for discussion.
16 DR. CERQUEIRA: If we have to support that, we can 17 do it individually, but we don't have any sort of committee-18 -formal vote on it.
19 DR. WAGNER: Can we address that when we address 20 our viewgraphs?
21 DR. CERQUEIRA: That's fine. Any further 22- questions for Cathy on the staff presentation?
23 DR. WAGNER: In regard to the training issues., are 24 you going to be saying anything different than what was said 25 in previous meetings? I'm very confused.
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l 59 I 1 MS. HANEY: There'are a couple of things. One is 2 that'I do~not believe NRC needs to approve training i 3' programs. I said that in March.
4 The other thing I will be saying differently is that we have split out'the training and experience
~
5 6 l requirements for the use of' strontium 90 eye-applicators. i 7 Inithe proposed rule.we recommended that the hours go up to-
, 8 match that for that for a radiation.oncologist.
9 Based on continued. discussion and.the impact on 10 the use of these devices, if we were to up these hours, we 11- . reconsidered whether we should makelany changes in this i j
,12 particular area.
13 We went back and looked at why we did it, which l 14 .was all the misadministrations we have had.with eye-15 applicators. The root cause,is really that either the 16- sources were not calibrated an untraceable to.NIST, or else 17 the sources were not decayed properly. So rather than put
- 18 ' in a training. requirement an up to three years and possibly 19'
~
patients couldn't use it because there wouldn't be 120- physicians that were qualified to use it, we put a 21~ requirement.in the rule very specific to this that said the J
22 2 sources have to calibrated to NIST and only-an authorized {
23 -medical physicist may decay the sources. .
'24 ~ We used a slightly different approach with this, i 25 but.my believe'is that this will fix it more than requiring ANN RILEY & ASSOCIATES, LTD.
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60 1 a physician to have the three. years of training just to use 2 the strontium 90 eye applicator. So that is different than 3 what I have told them.
4 MS. McBURNEY: Which training and experience?
5 MS. HANEY: 491.
6 MS. McBURNEY: So it's back to 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
7 MS. HANEY: Yes. It's back to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
8 The other thing that the Commission has not heard 9 before but.I.believe you all have is that under 290 and 390, 10 the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. We are no longer breaking down the classroom 11 and laboratory and the work and clinical experience. It's 12 basically physician complete a 700-hour training program and 13 cover these specific issues. It still says physics and math 14 and all that, but the hours are not there. Then these are .
15 .the things that we want you to master under the handling of 16 the material.
17 Off the top of my head, I think that is all that 18- they haven't heard before- .
19 '
From the standpoint of ACMUI, it's about the same 20 thing. All these hours were agreed to at the last meeting 21 with the exception of the 491 going back to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
22 DR. WAGNER: I understand the not approving 23 training programs. You are going to recognize various , board 24 certifications in the programs.
25 MS. HANEY: Right. We are still going to do that.
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61 1;
What vns have asked the' Commission to do is to give us
.2 permission to start that recognition process now so that
, - 13 everything is in place by the time the rule becomes 4 effective. -The nice thing about doing that, Lou, is it took 5 away theftwo implementation. effective dates of the rule
~
6- because we-were'having toikeep subpart J on the book until 7 we got boards approved, and no one understood why we had
~
8 subpart J requirements-plus the requirements in the modality 9 base sections. We said, well, once we got rid of the exam, 10 what is keeping us from implementing this immediately, and 11 it became the recognition of the boards. We though if we
- 12. start that right now, the boards have almost 18' months to 13 get'their requests into us.
14 The last two pages of that four inches of
.15 paperwork that you have is a model letter, and it says, dear 16 board, we are doing this rulemaking. We are going to start 17 the recognition process now. All you need to do is send us 18 a letter that says, dear NRC, I certify that in order to sit 19 -for my board the individual must complete the alternative 20 t' raining pathway, would have at least had so many hours'and 21 have a preceptor form. Sincerely yours.
22 DR. WAGNER: What about alternative training i I
23 pathways other than boards? l 24 MS. HANEY: The alternative is what you see on 25 page 27. You still need a preceptor.
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62 1 DR. WAGNER: There is no examination required.
2 MS. HANEY: Correct.
3 DR. CERQUEIRA: There is no hourly specifications 4 for any specific components the way it used to be.
5 MS' McBURNEY:
. -In the diagnostic. There is in 490 6 and 690.
7 DR. CERQUEIRA: Further questions for Cathy?
- 8. Lou.
9 DR. WAGNER: I am still trying to recall all the 10 rationale and the reasons. I know the boards all have 11 examinations. That's how you become board certified. You .
12 have to pass the examination. It's pretty stringent, and it 13- really is an incentive for people to study. In the 14 alternative requirements you don't have that. You have a 15 preceptor statements,-which seems to me to be a cushy little 16 way to go.
17 Why did we remove the examination requirement from 18 tche alternative pathway where they don't have one? You 19 wouldn't have to approve it, but you could require it.
H2O MS. HANEY: One of the reasons we removed was when 21 weLincreased the hours for the diagnostic users'over what
- 22 was in the proposed rule -- in the proposed rule we proposed 23 only 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of training. So when we increased the h.ours 24 we figured that the individual was getting more training, 25 and therefore there wasn't that much of a need for the exam.
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63 1 Then there were a lot of implementation issues 2 associated with the' examination that came into play. Also 3 we looked at the history. The easiest one is to look in the 4 radiation oncology area. Right now we have physicians that 5 are coming in through the alternative pathway, which is 6 basically three years and 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training.
7 We don't have a history to show that that has not 8 provided adequate radiation safety handling of the material 9 So without the justification of why is there a need for the 10 exam, I really couldn't justify it. The same thing for 11 users. In the 35.390 we actually increased hours.
12 Does the exam automatically guarantee that someone 13 knows how to handle a material safety? What we heard was, 14 no, it doesn't. We started looking for tradeoffs by 15 increasing the hours, by adding this increased burden on the i
16 precentor form. We felt that provided adequate assurance.
17 DR. CERQUEIRA: Dennis.
18 I MR. SWANSON: One of the questions I have is, 1 19 should this committee specifically go back and take a look 20 at the changes that appear in the current draft final for 1 4
21 390, 392, and 394 since there were some changes made there?
22 Personally, I have some problems with the 23 interpretation of some of that language.
24 MS. HANEY: Specific to training?
25 MR. SWANSON: Yes.
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64 1 MS. HANEY: Okay. I don't know if you want to do 2' Lthat or not.
3 DR.'CERQUEIRA: We have got the time. Not
- 4. everybody.has the actual language. I. don't.
5 -MS. HANEY: We have copies. Let me say this.
6- . What you might want to.do is focus on your viewgraphs first
_ 7 and maybe?everything'but' training and experience, and then 8 'come.back to that. .I think some.of these viewgraph',s as 9 soon as you decide ~who is going to say what and some key 10 points, we'can move real quickly through them and we 11 wouldn't be rushing through it at the end of the day, and 12 then we could have a little more time to focus on the T&A.
13 DR. CERQUEIRA: Why don't we do that. We will go 14 to Part 35 viewgraphs, the ACMUI. There is a total of.8
-15 pages there.
16 I guess we are going to have to delete John Graham 17 from.the people listed on the front.
18 'MS. HANEY: You can just say why he's not there, 19 because they will be looking for him.
20 DR. CERQUEIRA: If we go to page 1, we have sort 1
21 of~a briefing outline, which basically goes through what we
.22- are. going to do.
23 If'we go to page 2, we have the general comme.nts.
24 Dennis is not going to be.with us, is he?
25 MS. HANEY: No. Dennis had a conflicting i
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65 1 engagement this week. l' 2 DR. CERQUEIRA: We are going to talk about what is 3
there, what we are going to say, and who is going to say it. ;
4 I Does anybody have any disagreement with any of 5 those bullet items?
6 MS. McBURNEY: I think it's pretty much what we 7 had last time.
l) 8 DR. CERQUEIRA: Yes.
4 9 MS. McBURNEY: I would still concur with that.
10 MS. HANEY: Chairman Dicus will hand off to you.
11 DR. CERQUEIRA: I could do these general comments.
f 12 It doesn't take much input.
I 13 MS. McBURNEY: The outline and the comments. l
/
14 DR. CERQUEIRA: Then we go to the next item, which 1 j
15 is the Radiation Safety Committee.
16 MS. McBURNEY: I did that last time.
l 17 DR. CERQUEIRA: We can have Ruth do that.
- 18 DR. WAGNER: I don't see what we are going to say 19 that is any different.
20 MS. McBURNEY: Did this change?
i' 21 MS. HANEY: No. Lou is right. The safety 22 committee is not an issue. They may ask questions based on 23 do you think that two is the right number, should it be, 24 three or more. I honestly don't think they will get at that 25 level of specificity. This is more going on the record, AID 7 RILEY & ASSOCIATES, LTD.
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66 11- .saying again what you said.
.2 :In essence, there is very little that I'm saying
'3. 'that'is new too. Maybe about five minutes worth of what I'm j 4 saying:is different from March.
5 DR. WAGNER: So there are going to be less
-- 6 . Commissioners that we are going to be talking to this time. ,
7 MS. HANEY: Yes.
8- DR. . WAGNER: There'are not going to be any 9 different Commissioners, are there? Are there going to be 10- 'any Commissioners there who weren't there last time?
11 M
.S. HANEY: No, unless Meserve is in t?e audience.
12 MS. FLACK: They are really still interested in 13 this issue.
14 DR. WAGNER: About the Radiation Safety Committee?
15 MS. FLACK: Yes.
16 DR. WAGNER: I'wish we had some perspective on 17 their concern.
18 MS. HANEY: I will tell you their concerns. One 19- could be this is a prescriptive requirement, that we are 20 . telling a licensee you have to have a committee. That is 21- one side of it. There.are those that are arguing we should 22 not have prescriptive requirements. Then you have all the 23- public comme'nts that came in from the physicists commun,ity 24; saying that the Radiation Safety Committee is very good and 25 serves a useful purpose.
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67 1
So they are trying to balance a quasi-prescriptive 2 requirement because we have made it much simpler than what 3 it is right now. Basically it says meet once a year and 4 look at your program as compared to meeting four times a 5 year and all of that.
6 This is a risk-informed approach to the Radiation 7 Safety Committee, recognizing that if you only have l
8 diagnostic nuclear medicine, you don't need a committee. j 9 The buzzwords of the day, if you can get all of !
' i 10 these into every viewgraph, you get your travel reimbursed.
11 [ Laughter.]
12 MS. HANEY: These are the buzzwords of the day:
l<
13 MaintaAn safety, reduce regulatory burden, public 14 confidence, and efficiency and effectiveness.
15 We weren't using those words back in March, Lou.
16 Any time you can incorporate these words without saying 17 Cathy told me to say this.
18 DR. WAGNER: That flows very well with the 19 recommendation.
20 DR. CERQUEIRA: Certainly for the Radiation Safety 21 Committee. Basically we have allowed the single use 22 physician who can act as his own radiation safety officer.
23 Ruth, do you know what E, F and H are? When , Cathy 24 did her presentation she basically identified.
25 MS. McBURNEY: I wrote those down.
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.m 68 1 DR. CERQUEIRA: If you are doing dangerous, 2 multiple source radiation, then you do need the committee.
3 MS. FLACK: Cathy mentioned early on that the 4 Commissioners were especially interested in the effect on 5 the stakeholders.
6 DR. WAGNER: Maybe it would be good to mention to 7~
the Commission that administrative law is when you have the 8 higher risk situations. Administrative 1y it is much easier 9 for the physicists and the radiation safety individuals, whc 10 are mostly the ones concerned about this, to justify the 11 establishment of a committee. When you don't have the .
12 regulatory requirement behind that, they don't have the 13 administrative authority to get that done.
14 I think it is something that is needed in this 15 case. So it's a very reasonable to do to satisfy that need, 16 because it says it's something that is important.
i 17 MS. McBURNEY: As was mentioned earlier, there are l 1
18 probably not oncologists that do all these things. It is 19 good to have them come together and talk to each other.
20 DR. CERQUEIRA: Exactly right.
21 Dennis, any comments on the Radiation Safety 22 Committee?
.23 MR. SWANSON: No.
24 DR. CERQUEIRA: We are going to skip the training 25 'and experience, page 4, and we will come back to that.
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69
.1 Then;we are going to go to medical event. Lou, 2 you.did that last time?
3 DR.' WAGNER: I don't think'so. That was dane by 4 Dr. Stitt.
5 DR. CERQUEIRA: :Yes, Barry.
6 DR. SIEGEL: Suggestion. Reject it immediately if 7 you' disagree with me. I'have a concern that splitting this 8 up so much in-terms of the formal presentation of the slides 9 is. going to come off looking like'a dog and pony show as 10 opposed to'you.just.doing it fairly quickly, making the R11- point that what you are largely doing is reiterating 12 important issues that you brought to the Commission's 13 attention'at the last. briefing,-and that you and the other s
14 members at the table are prepared to address their very 15 .- ' specific questions on some of these issues at the conclusion
- 16. -of.the presentation.
17 I think that if you keep passing the baton, it is 18- ^ going to look peculiar. 'That is just my sense listening to 19 lyou talk about how you are going to do it.
- 20. DR. CERQUEIRA: We could certainly do it that way.
21- That would give them the opportunity to focus on the 22 ' specific issues that they have raised which we are not fully 23 -aware'of. .
24 DR. WAGNER: -I would much rather do it that way.
- 25 Then'we could address their concerns.
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70 1 DR. SIEGEL: That is especially true if what Cathy 2 .said is correct, that Greta Dicus will let you get throagh 3 your presentation before you start getting interrupted. If 4 you are going to get interrupted at every slide, then there 5 is some advantage to identify who the appropriate respondent )
l 6 is, but if you are going to get through it, then when there 7 is a question about the pregnancy stuff, you can say, I'd 8 like to let Dr. Wagner address that question because he is 1
9 the world's renowned expert on radiation exposure of a '
10 potentially pregnant female.
11 DR. CERQUEIRA: That's fine. I would be very 12 happy to do that. I guess if we go all the way through it, 13 would it help to bring back the viewgraphs, or should we 14 just let them basically do a free form question and answer 15 session?
16- MS. HANEY: After you do your presentation, Dicus 17 will open it up. She goes first and asks all of her 18 questions. Then she will turn to McGaffigan. McGaffigan 19 will jump you all over the place. Then Merrifield will do 20 the same thing.
21 DR. CERQUEIRA: We don't know if Diaz is going to 22 be asking.
23 MS. HANEY: If the phone line works, he will i
24 actually come after her. They go in ranking order, 25 seniority order.
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71
- 1~ DR. .CERQUEIRA: That would be a good way to do it, GL because they,will already have the viewgraphs ahead of time, 3
and I'm sure their. staff'has sort of brief them.
4: MS. HANEY: They already have these.
5 MS. McBURNEY: They probably already have their 6' questions. i 7 MS. HANEY: They_do.
8 DR.. WAGNER: So the idea would be that1we won't be 9 addressing this-individually, that you are going to be going 10 through the. slides as a_brief overview, and then we are to 11 .say the; te are here to answer for the ACMUI any of the 12 concerns that you may have regarding our position on these 13 . topics, 14 DR .' CERQUEIRA: Okay.
15 DR. WAGNER: That really is good, because that 16 cuts to the chase.
17 .DR. CERQUEIRA: Excellent suggestion.
18 MR. SWANSON: One comment would be, do you want to 19 specifically comment on any changes since.we last talked?
20 _DR. CERQUEIRA: Am I going-to remember that?
21_ . Cathy,.what did we change?
22- MS. McBURNEY: We need to go through them. !
23 DR. WAGNER: I don't see anything we changed.pn 24 the Radiation Safety Committee.
i
- 25. 'MS. HANEY: The T&E, there was a change. ;
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72 1 Then cn1 viewgraph 6, in March when we briefed the 2 Commission we said 5 rem. We were pushing it to go into 3 Part 20. Regardless of whether it went in part 20 or not we 4 ' wanted it-at a 5 rem level. I guess that really isn't a 5 change.
6 I can't emphasize enough that you emphasize the 7 impact on medical practice in this particular area based on 8 what is really happening out there. That's the public 9 comments that'we received.
10 Viewgraph-7'is a change b'ecause this alternative 11 rule text came into.being. Say you haven't changed your 12 mind on.the first one; you still believe that, but whatever 13 you want to say on the second bullet.
14 Implementation challenges is really the same thing 15 with the exception of this'early recognition of medical
'16 specialty boards, and.you all are in the right place to say
'17 we really think they should move ahead because we want this 18 in place by the time the rule becomes' effective.
19 DR. CERQUEIRA: 'Right.
20 Niki,1there are two items where your input would
' 21' really be helpful'to the Commissioners, and that is the 22 unintentional exposure to the fetus or the embryo and the 23 notificatiod. 'They kind of see us as professionals who,to 24 scxma extent have a vested interest or an agenda to promote.
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73 1 about the notification, and I think if you could make some 2 of those points, it would actually have much more of an 3 impact coming from you than coming from us.
4 MS. HANEY: I think they will ask directly. My 5 guess is there will be a question ('.rected directly at Niki 6 about that.
7 I think when you do introduce the members sitting 8 with you, Dr. Cerqueira, it probably is good to say the 9 perspective that they are coming from so that they are aware' 10 that Niki is patient rights.and Ruth is state and Lou is 11 physics.
12 DR. WAGNER: Shall we go through the slides and 13- see what we are going to say?
14 DR. CERQUEIRA: Yes.
. go through and then I 15 will give them the opportunity to ask questions'.
16 We have identified minimal changes other than the 17 training and experience in terms of what we presented last 18 time and this time.
19 I am not going to make additional comments on 20 these things. l 21 MS..HANEY: At the same time, you don't need to l
22 read them the viewgraphs either. Ruth is right. They have '
23 had your viewgraphs for other a week now, and they pret.ty 24 know what you are going to say based on these viewgraphs. I 25 would pick a couple of things out of each one of these ANN RILEY L ASSOCIATES, LTD. ' ;
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4 74
- 1. viewgraphs that you want verbally on.the record. A lot of
'2 thelbriefing is getting things on the record.
2 3 JO n page.2,-for example. I think you could-4 .probably say theJACMUI does believe1 that the draft final
. rule.is risk-informed and more performance based, and we do
~
5 6 see'where'there is.a focus on the higher risk procedures.
7? LThat almost covers that first bullet.
8 'On the stakeholder involvement -- I'm not making 9 you say these words -- we endorse the Commission's efforts 10 to involve the public in this'throu'gh the entire process.
11 We. recognize that there have been several public meetings. .
12- This is one-where you might want to hit the public 13 meeting aspect. Involving the regulated community, you do 14 recognize that the rule has changed for the best because of 15 this involvement.
16- DR. WAGNER: I don't suspect the Commission is 17 going'to have any direct questions with regard to these 18 general comments.
'19 MS. HANEY: They. won't,'but I will tell you, Lou, 20 they have'really been pushing the stakeholder involvement.
'21 That is all I.would say about this viewgraph, and I would 22 move on.
23- DR. WAGNER: So Dr. Cerqueira should just mak,e 24 sure'he emphasizes that stakeholder. involvement issue.
25 MS. HANEY: Yes.
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75 l' .DR.. WAGNER: It's the other slides that are really 2
the meat',.because the-Commission has to come back and say, 3- okay,:now~we.have a question about the ACMUI's position on 4 this issue.
LS MS. HANEY: 'y e s ,
~6 DR. CERQUEIRA: Right.
7 DR.-WAGNER: Are there an issues with regard to 8 the Radiation Safety Committee other than what we already 9 discussed? I don't think-so. '
l L 10 MS. HANEY: 'I don't think'so.
11 DR. WAGNER: We are going to come back to training
- and' experience. Is'that true,-Dr. Cerqueira?
'13 DR. CERQUEIRA: We keep saying we are going to 14 come back to it. Should we just do it now?
i
= 15 ' MS. McBURNEY: Let's just do it. l
~ 16- DR. WAGNER: Let's just do it.
17 DR CERQUEIRA: We said before clinical
)
18 ' environment; the alternative pathways in addition to the 19 boards;cthe preceptor statements.
20 Do we want to emphasize some of the changes that 21 we have put'in here, getting-into the details?
,~ 2 MS. HANEY: I don't think so. I think it's
' 3, sufficient to say that you endorse the alternative path.way, 1 .
I 24 . period. . That is at least what we heard at the March from 25 j. you guys. Then just drop it there and let them come back ANN RILEY & ASSOCIATES, LTD.
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76 1 and ask any rnecific questions.
2 We have a letter from the American College of 3 Radiology, saying that they are happy with the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
4 That is about the only letter that we have received since 5 the draft final cas made available to the public on the 6 hours.
7 The American College of Nuclear Physicians S&M did 8 submit a letter to us that commented on several areas in the 9 rule but it did not specifically address the duration of the 10 training program.
11 I am assuming that everyone is more or less happy 12 with wPc'e we are because they haven't sent me any letters.
13 DR. CERQUEIRA: Either they are happy or they are 14 just tired. We've worn them out.
15 I have a pretty good handle on this. The things 1
16 that we said we wanted to emphasize during the discussions 17 we had the other day was basically the national standards.
18 I can make some good points there, I think.
19 DR. WAGNER: Is there anything that we should be 20 concerned about with regard to Commission queries or 21 rumblings or issues with regard to training and experience? l 22 MS. HANEY: They may ask you about the I-131
)
23 endocrinology use, because that is something that they heard !
24 from SR-6 Committee.
25 DR. WAGNER: The issue being the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of '
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I 77 1 . training?;
2 MS.,HANEY: Yes. Do you_.believe 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is f
'3 sufficient'or do you believe that it_.should be raised to 700
-4 hours?
5 'DR.' WAGNER: I'think the committee's s.nswer to 6 'that is weLagree with the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />.
l 7- MS..nANEY: Correct. That's what you have told 1, 8 me.
9 DR. SIEGEL- And.the safety record that has been 10 presented. 'I l
L 11 I'think.you would also probably.want to emphasize l
12 on'that'last bullet-that even though this is Part 35 and you i
13 are doing a. lot, the Comn.ission is not' off the hook, because
- 14. it isJgoing to need to grapple with what to do with training 15 'and experience requirements for intravascular brachytherapy 16 .and'other emerging technologies in the very near future.
17 DR. CERQUEIRA: Right. I think.the FDA is about *
- 18 : to approve one of the devices for intravascular 19 brachythe'rapy for' cardiac use.
'20 I think we &re pretty much in agreement from the
-21 committee in terms of the regulations that have been 22 proposed-.
i 23 _The medical event, endorse the final draft rule. '
j j 24 DR.' WAGNER: This is one we are going to have- )
25- trouble'with because we don't have good representation on 1
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m 78 1 the committee from oncology. What should we be on our guard 3
2 about here?
3 MS. HANEY: Actually, I have not heard anything 4 from the Commission with a concern about medical rvents at 5 all. That doesn't mean they won't bring something out of 6 the woodwork on us, but I think this is basically we like 7 where the threshold is.
8 This one I did not talk about in my presentation.
9 At this point it is one of ,the lesser issues with the rule.
10 We did1 include it here because the ACMUI addressed it back 11 in March. We felt that this would be something more that 12 you might.want to endorse again.
13 DR. WAGNER: I can't remember exactly what all our 14 criteria were. I know we endorsed it, but I can't remember 15 about the adequately capture events of concern and the dose i 16 thresholds. I couldn't recite those right now.
17 DR. CERQUEIRA: Can you do that, Ruth? I don't
.18 think I can.
19 MS. HANEY: I don't think we are going to that 20 level of specificity on this. The big issues were patient 21 intervention and wrong treatment site. I think if you just 22 say that the changes to the rule adequately address those 23 two issues, they are not going to go further than that. I 24' may be eating my words at 11:30 tomorrow.
25 DR. WAGNER: We can only prepare to the extent ANN RILEY & ASSOCIATES, LTD.
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79 21- . that it's reasonable.
~2
'I will:have to-do a. song and
~
DR. CERQUEIRA: .
3 dance- .If,I am really stuck, if people know some of the 4 Linformation,;please~ volunteer.
j 5- Six is the unintentional exposure to 6 nembryo/ fetus / nursing cnild. I think that is pretty J7 self-explanatory in terms of the threshold.
(
8 DR.~ WAGNER: !The' thing that I am going to address 4 9 -there,..which apparently you tell me is their concern -- I
- 10. must admit-I really'get disappointed when people try to 11 compare this situation with the embryo as being a member of 12 the general public. That is just so inappropriate. You-13' 'can't compare this to an embryo'of.a working mother. That 14- -embryo is clearly a member of.the general public. You can't 115 compare.this to an embryo of a member who is out there 16' walking on the street or walks.by your facility or even 17 ' works as as secretary within your facility. That clearly is 18: a member of;the general public.
19 This is a woman who is. sick and happens to be 20 . pregnant. -You cannot" separate those two biologically. .You 21 cannot treat'those two. independently. You always have to do
.22' 'it'with the-ful] recognition that that woman is pregnant'.
.23; Therefore, this' is note a member of the' general public, and 24 quit comparing it to that. 'That's the problem. !
z 25L >Then from.there on we have:to discuss the level of I
i i
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m 80 1 reporting. ;That's the point.
J' 2
~
Okay.
.DR. CERQUEIRA:
3 DR. WAGNER: I don't know whether there is
- 4. anything else I'should be aware of on this issue.
5- MS HANEY: Somewhere is going to come up the 6 -impact onJmedical care. What_I will have said already is 7 .that this possibly could lead to an increase in pregnancy 8- ' testing because.there are'several diagnostic tests that will 9 trip. the 500 millirem level . Barry gave me some information 10 about the different diagnostic tests that would trip the
" 11 ' level, and.there are several, eight cn nine or so. Are you .
12 -going to pregnancy test as a result of it?
13 The other issue would be the preferred provider 14 issue, that thel nuclear medicine facility may not be the 15 same one as the laboratory as far as preferred provider, so
-16 now you've got anJissue with the patient having to go 17- multiple places.
18 Somewhere along the line we heard that there was a 19 chance that HCFA ndght not reimburse for this type of 20 ' pregnancy test,.but I don't know if that is true or not.
21' Maybe.someone here knows- .
22 DR. SIEGEL: HCFA is not entirely relevant since
'23 verysfew pregnant = people are 65 or older.
'24. MS. HANEY: Y6u never know.
25- .DR. SIEGEL: .It could be Medicaid.
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81 1 MS. HANEY: Insurance. Somebody said it.
2 'These are not in order of importance. The other
~ 3-big'one is.that physicians may start ordering other types of 4 diagnostic tests that would be less effective. Therefore
- 5. you-are impacting the health care to the female population.
6- MS. McBURNEY: The other one that might come up 7 is, isLthere a level greater than 500 millirem that will not
'8 - =have an impact?
9' MS. HANEY- That may come from Merrifield. As I 10- .said, Barry went through this and I'should have Xeroxed this
'11 for you. It looks like most of the diagnostic tests, if the 12' threshold was a 2 rem -- we talked about this before. I 13 think you said, if I had to live with something less than 5, 14 I could go with 2. Two might be pushing it a little bit.
15 ~ We-might want to go up to 3 rather than 2. Split the 16 difference.
17 DR. WAGNER: The issue has to be based upon 18- something that is solid and something that is real. It 19' -can't be something that is fictitious or artificially made 20 up.
21- MR. SWANSON: Let'me ask you this question. I
-22 Junderstand the congressional reporting requirement of 5 23 rems. What'is the'NRC going to do with reports between,2 24 and 5 rems?
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82 1 could look at the circumstances of why the event occurred.
2 We could get information out to other licensees under an 3 information notice of don't let this happen to you.
4 MR. SWANSON: Is that in turn going to lead to you 5 coming back and saying, well, you should have pregnancy 6 tested.this individual? What are your alternatives?
7 MS. HANEY: Right now we are pitching this as a
-8 reporting limit and not a dose limit. I don't want to'tell 9 ' you if you call me and tell me that you had somebody at 1 10 that we wouldn't come out and do an inspection. Just 11 because you trip this level does not mean that it's a 12 violation or it doesn't even mean that it is a violation.
13 We are gathering this information and we would 24 compare it against what the standards of practice would be.
15 For diagnostic tests it is just ask the question. As long 16 as your techs are just asking the question and if the 17 patient lied, there is nothing your techs can do about it.
18 If you get into the therapy area, the standards are the 19 pregnancy test.
20 DR. WAGNER: This whole issue is going to get 21 extremely complex. In reality, if you want to deal with 22 this on the perfect level, you have to go into what is the !
23 gestation age and what is the dose and what is the risk. l 24 associated with that, and all these other things. Tbat is 25 not something at the reporting level that we should be i
+
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83 1 getting into. It is just too complicated. Those are all 2 medical issues. What we need to do is make sure that this 3 thresh old applies to all stages-of pregnancy, from even 4 prior to conception, at the ripening of the follicle. Go 5 all the way back, and then from there on out.
6 It is very difficult to address this in an 7 approprihte way, because from a regulatory basis it 8 shouldn't go there. So we need a threshold that is proper 9 for reporting, that takes into ac. count all those issues.
10 That is why we have been emphasizing the 5 rem issue. That 11 basically covers it from the reporting point of view.
12 DR. CERQUEIRA: Is this controversial with the 13 Commissioners?
14 MS. HANEY: Yes, it is.
15 DR. CERQUEIRA: We have presented this to them 16 before. Do you think they will have specific questions? l l
17 MS. HANEY: Yes.
! 18 DR. CERQUEIRA: Given that we have already made j 19 recommendations?
20 MS. HANEY: If I had to guess, this and patient 21 notification is what you are going to spend your half hour I 22 talking about.
l 23 DR. CERQUEIRA: Here is where Lou can certainly 24 provide all the factual information.
25 Niki, do you have a strong feeling on this, or do ANN RILEY & ASSOCIATES, LTD.
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84 1- you-fully understand the' issue that is involved?
2J MS. HOBSON: On the 50?
3 DR. WAGNER: 50 millisieverts versus the 500 4L millirem.
5- DR'. CERQUEIRA: Part of the implications of this 6 is that'you would basically almost have to do a pregnancy 7 test on every woman within childbearing age wno is getting 8 these ttudies done, which would have tremendous financial 9 implications,-but more importantlyi really would not reduce 10 infany significant way the risk to the fetus.
11 MS. HOBSON: If she does happen to be pregnant, 12 you are going to scare the woman out of-her wits. The 13 popular culture of any exposure to radiation is that it's 14 going to produce three-headed monsters. That is'the image.
15 MS. McBURNEY: This is a reporting level to NRC 16 that we are talking about now.
17 TR. WAGNER: Right.
18 MS. McBURNEY: You would not have to tell?
19 MS. HANEY: It's both, Ruth. That is part of what 20' Lou'is getting at. The importance there is that once you 21- . report to NRC, then you are also notifying the woman, and 22 you may be notifying her at this very low threshold. If it
'23 is the 500 dillirem threshold, are you unduly alarming .this 24 woman?
25 DR. WAGNER: I think the other issue that is very l
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important is the coverage of the very early pregnancy and 2 how the reporting level of 500 millirem essentially 3
conflicts with standard of care in regard to the pregnant j 4 woman who is sick and how we manage those issues. Cl:arly 5 this 500 millirem is in conflict with that. Therein lies 6 our dilemma. We have to make sure that the reporting 7
l threshold is appropriate for all the stages of pregnancy.
8 MS. HOBSON: What happens you know a woman is 9 pregnant and she also has a fatal disease?
)
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10 DR. WAGNER: That is not unintentional. This only )
' i 11 refers to the unintentional issue. '
12 DR. CERQUEIRA: Barry has got a comment.
13 DR. SIEGEL: That is the entire problem here. The 14 problem is that the current standard for the vast majority 15 of diagnostic tests is to use a variety of mechanisms to try 16 to determine whether or not a patient is pregnant short of !
17 doing formal pregnancy testing on everyone, which still l l
18 misses pregnancy in the first ten to 14 days. So you can't l
19 know about that even if you did pregnancy testing. '
20 The only way you could do that is do what has been 21 recommended in some European countries, which is actually in 22 order to perform radionuclide therapy is to do a pregnancy 23 test, then provide the patient with careful instructions 24 regarding birth control and/or abstinence, and then 14 days 25 later do a repeat pregnancy test, and then administer the ANN RILEY & ASSOCIATES, LTD.
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86 1 therapy, which is insane. Just insane.
2 Since you are dealing with a patient population 3 where the standard of care is just to ask the responsible 4 question, then once you know whether or not the patient is 5 pregnant -- let's assume the patient is pregnant -- for the 6 vast majority of these diagnostic tests you now say to 7 yourself, is there a better non-radiation diagnostic test 8 that could answer this question? If there isn't, you do the 9 test anyway. So even knowing that the patient is pregnant 10 doesn't change your behavior as a physician.
11 That is in some ways, Manny, the point that I 12 think you need to make most importantly, that this has the 13 potential to really interfere with the way we make decisions 14 from moment to moment, because it is putting the NRC in this 15 reporting requirement in the position of maybe telling us 16 that we shculdn't be going ahead and doing this tect based 17 on our best belief that tr's patient is not pregnant :,ecause 18 of concern that we might later find out that she was 19 pregnant.
20 DR. CERQUEIRA: That is a good point that I could 21 make.
22 Ruth, do you have any comments that might help 23 Niki?
24 MS. McBURNEY: I think setting it at 5 as a 25 reporting level does address what Lou is saying. At that ANN RILEY & ASSOCIATES, LTD.
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11evel,::.from a regulatory standpoint, then you might want'to
<2l- i go back and look at were there.any procedures that weren't 3: followed.
)
4 DR. CERQUEIRA: JWe will go through this. Lou, I 5" -think we will depend heavily on you if there are specific 6~ questions ;OlL".ed to this. Basically it doesn't change very
'7- -much from'tne position that weLsaid before.
.8 MR.'SWANSON: Is 'there any way we can tie the buzz 9: 'words:Luto this argument? ,
_10- DR.-WAGNER: I'will do my best.
11 MS. McBURNEY: -What werezthose again?
12 DR. CERQUEIRA: Maintain safety, decrease-
- 13. regulatory burden, increase public confidence, and 14- ; efficiency and effectiveness.
15 MS..McBURNEY: It's' consistent with what you.are 16' reporting to' Congress. j 17_ MS. HANEY: What they may do is argue public E18 confidence. If you take those that have the idea that any
.c 19f radiation is going to produce a'three-headed baby, how does
'20: .NRC. setting a reporting limit at 50 millisievert increase J21 public confidence?
- 22. DR. WAGNER: I think at this point the answer to 23 cthat-is:quite. clear. It's not a matter of public ,
'24- confidence;.it's a matter.ot ,'atient' confidence.
25: MR. SWANSON: Congress has set a. reporting limit l i
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88 1 at 5 rem.
2 DR. SlEGEL: No. The NRC set the reporting limit 3 at 5 rem.
4 MS. McBURNEY: To Congress.
5 DR. SIEGEL: The Congress didn't tell them where 6 to set the number.
7 MS. McBURNEY: But it's consistent.
8 MR. SWANSON: Now we are arguing about defining a 9 lower reporcing limit. Why are we even arguing that point?
10 NRC has already set it at 5 rem.
11 MS. HANEY: I think what you are arguing though, 12 Denpis, is we have the reporting requirement to Congress at 13 5, .but e'cery other one of our reporting requirements is 14 lower in the regulation. So our policy in the past has been 15 we want to hear about things before we have to tell 16 Congress. This would be the only AO reporting requirement 17 that we would not hear about until it hit the threshold that 1
18 we needed to report to Congress.
]
j 19 MS. McBURNEY: The difference is that this is a I 20 patient versus a normal member of the public. ,
21 MS. HANEY: That is actually what got us down this j l
22 path. About two years ago we revised our abnormal
]
.23 occurrence criteria, and this was one of the items that was l 24 caught up in that revision, and the Commission came back and j 25 said, wel'1, it's a great AO criteria, but if you don't have j ANN RILEY & ASSOCIATES, LTD.
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...w 89 1 the, requirement for a licensee to repor't'to us the 2' information, then we are not going'to be able to tell
- 3 Congress about it. So the direction was to-incorporate this
'4 into the: regulations.
- 5 It is almost'something that should go into a more
.6- . general requirement, either our Part 20 or Part 30, 40 or 7- 70, which'are' specific to the use of the material. This is 8 not~just limited to medical. We considered a' lot of things, 9 and'the best thing was let's just fix 35. Where most of 10 these reports are going to come from are going to be the
.11- medical environment as compared to non-medical. Once we get 12 this all done, we will go back and look and see if we need
-13 ; to do rulemakingslin any other areas.
14; DR. CERQUEIRA: Dennis.
15 MR. SWANSON: I can't seem to get my point across.
16 It seems like the NRC has set'as the reporting limit to 17- Congress that there is a safety' issue here at 5 rem. It 18 seemsfto me like the only reason why we-are reporting them 19 at'500 millirems is to satisfy an advance notice situation t
20 for the NRC, which has nothing to do with safety. In fact, 21 it erodes the patient-physician relationship, so it is 22~ eroding-public confidence. It increases regulatory burden 23 3if'we'go the.500' millirem reporting requirement.
12 4 - You have established a safety level already. This 25' Lis just advance notification. That's all this is, o-
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DR. CERQUEIRA: Those are very good points.
2 'DR. WAGNER: Another case of a regulation written 3' for the.. sake.of a regulator.
4 MR. SWANSON: Right. So what are going to do with 5 this information?
6 HDR . CERQUEIRA: Those.are good points. I will try 7 to.makelsome.of_those and let Lou handle the more detailed 8 questions.
9 Niki, if.ycn1 could make some comments on this, it
?would help.
' 10 1 - 11 Page 7 is notification following medical event or 1
12 exposure to embryo / fetus / nursing child.
13 MS. HANEY: .W hat you are battling against here is 14 .at level of assurance does JUIC need in order to assure 15 that the patient was informed.
16 DR. WAGNER: This is where we have to go back and 17 address.what we were addressing earlier about whether the
- 18 ACMUI is now take a position on this alternative rule that 19 might come as a compromise. Is that right? I I
20 DR. CERQUEIRA: . What page was that?
21- MS. HANEY: Let's-try just looking at the last 22 page-of my viewgraphs. At should be number 28, which is.
23 1 alternative ' rule text. The notification part stays the, I
l 1
24 1 same. You still have to notify the referring physician and 25 the individual. That's the same.
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s 91
~1.
Under certification, you are actually certifying 2 that the: licensee notified the individual. We would get a 1
- 3. \
letter that~said, "I certify that the patient was told,"
4 period. That's'all the information NRC would get.
5 The business about the copy of the report and a 6 description: of - the event, we.would stay away from that. The 7 concern-from the Commission is going to be, are. physicians 8 telling their patients when medical events or 9 I misadministrations happen? j 1
10 .There have been just as many articles published )
11 :that say, . no, they are not, as'there have been saying, yes, ,
12' they.have been. You can't go article against article on it.
At the March briefing the committee was asked in
-14 ~ other areas of' medicine are you telling the patient. If the 15 answer is yes, then I think'you need to come across and say 16 yes, we are telling the patients. Just kind of leave it 17 there. -They are looking for that assurance that it is lL 8 happening.
19 DR. WAGNER: Are.you saying there is no change to
- 2 'O the rule itself except the enforcement issue?
21' MS. HANEY: Lou, in the draft final rule text we 22 ;keptithe requirment as is. We had no reason to change it at
'23 that point, because everything-we have gotten officially 24 .from the Commission says continue to' require patient 25: ' notification. l l
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92 1 In the March SRM they gave us a little bit of a 2 window and said, however, you can give us alternative rule 3- text that would allow:for certification. This is what this 4 is. Th'y e have it as an attachment to the rule package.
5 What you want the Commission to do is to replace 6 the rule' text that is in the draft final rule with this 7 alternative rule text if they will not delete it.
8 :Lf they will not eliminate the requirement, you 9 'can_do.your pitch for why it should be eliminated, and you 10 can even stop there and let them come back an ask questions 11 on the other.one. Like I said, you don't need to say .
12 everything that is on the viewgraph. They may come back and 13 say, but on your viewgraph you said. Then I think you can
- 14. say,'well, as a compromise the alternative rule text is 15 better than what you have right now.
16 DR. WAGNER: Tell me if I'm' wrong. If we go that 17 route, then the notification issue would be basically 18 . eliminated and replaced with a certification issue.
- 19. MS. HANEY: No. You would still have the 20 -notification. E would still stay in the rule text.
21 MR. SWANSON: What she is basically saying is that 22 would still'have the requirement in the rule text that you 23 have to notify the' patient. What you are doing away wi.th is 24 -the requirement that you have to give the patient a copy of 25 the written.information. You can. verbally notify the I
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Then what the NRC wants to see is a certification 2 g statement that says "I notified the patient," period.
3 DR. SIEGEL: That gets to the heart of one of the 4
problems, which is that you go and you talk to the patient 5 on the day the event occurs and you say, we did this, it was 6 a mistake, we're sorry, we have to reschedule your test 7 because we gave you the wrong stuff, the radiation dose is 8 not a problem. Then 15 days later the patient gets a very 9 '
formal looking letter and they say, you know, maybe that 10 doctor wasn't telling me the truth. I'd better call my 11 lawyer.
12 That is what doctors are fretting about. As it 13 turns out there is almost no case history that indicates 14 that this leads to malpractice litigation, but by the same 15 token it is just one more thing. To use Dennis' term, it 16 erodes the patient-physician relationship when it's just a 17 face-to-face conversation about this is what we did and '
18 these are the potential consequences.
19 DR .. WAGNER: So this does eliminate the written 20 notification?
21 DR. SIEGEL: It gets rid of the written 22 notification.
23 MS. HOBSON: If there is no possibility that harm 24 was done to the patient, what is the purpose of the 25 notification? Why should you tell them anything unless ANN RILEY & ASSOCIATES, LTD.
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94 1 there is real potential for harm? I think the patient does 2 deserve to know.
'JF MS. McBURNEY:' I think the patient deserves to 4 Lknow.
5 MS. HANEY: NRC has taken a positio:i that the 6 ' patient should be told and the patient needs to know.
7 'MS. HOBSON: But it is so frightening. If you are 8 ~a. cancer patient, you are already fighting for your life.
9 'Then you have this additional burden put on you, which 10 doesn't solve any problem at all.
11 MS. HANEY: Niki, that is what they are going to 12- look.to you tomorrow to say. They were saying specifically
.13 were you going-to be at the meeting. I think tomorrow you
-14 need to say-that to them.
15 :We have had previous patient rights advocates that 16 were very much in support of the rule. But you are coming 17 at it from a different perspective.
18 DR. SIEGEL: You are addressing the issue of 19f therapeutic-privilege, which is a very important one. In 20- general, the ethical principle says that if a doctor makes a 21- mistake, you should tell.the' patient you made a mistake even 22 if:it's inconsequential.
-23 What'you were just addressing was if my telli.ng 241 -this patient'may actually put this patient.less at ease 25 Loverall or may -- I don't want to use the word " harm", but ANN RILEY &. ASSOCIATES, LTD.
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95 1 may in fact make this patient's anxiety level higher l
2 inappropriate, with no benefit, then my therapeutic 3 privilege as a physician acting literally in that patient's 4
best interest is to just keep on going and not bring it up.
5 On the other hand, if I'm always acting in my own 6 best interest, I'm better off getting it right out on the 7 table and saying, I made a mistake. The court records on 8 that are eminently clear. I am far more likely to have 9 major damages assessed against me if I tried to cover 10 something up 11 MS. HOBSON: It isn't my purpose or agenda to try 12 to protect the physician. If a physician does something 13 that is wrong, that is malpractice o2 against medical 14 ethics, et cetera, they should pay the price. But if it's 15 within the tolerance that we have been talking about wh'ere 16 no actual harm has occurred, I think the act of notifying 17 the patient is harmful because it increases the stress 18 level. As Dennis says, it erodes the patient-physician 19 relationship. It makes the patient less confident that the 20 world is going to be okay, that the medical community can 21 take care of my illness.
22 MS. McBURNEY: But there are levels. It is not 23 within those tolerances. It is that that falls outside that 24 tolerance.
25 MS. HOBSGN- tau aren't those levels set so ANN RILEY & ASSOCIATES, LTD.
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96 1 conservatively that you can really predict whether or not 2 that is going to cause harm? Unless there is scientific 3 documentation that this misadministration or medical event 1
4 is going to cause harm to the patient, I feel very strongly 5 that it is harmful to drag them through this notification 6 process, because it just raises all kinds of other worries 7 in their minds, and they have got enough worries already.
8 DR. CERQUEIRA.. That is a good point. I think the 9 staff's alternative basically makes certain that you don't 10 have physicians that are doing this repeatedly, because now 11 they are still required to notify the NRC.
12 MS. HOBSON: I don't have a problem with notifying 13 the NRC.
14 DR. CERQUEIRA: Yes, but the patient would also 15 receive this notice. Even though the patient has been 16 reassured and everything, it would create a whole lot of 17 other problems.
18 Dennis.
19 MR. SWANSON: I think you also need to understand 20 the regulations do allow at the advice of the referring 21 physician not to notify you if they do think it's stressful.
22 I think Dr. Siegel pointed that out. If it is viewed that 23 it would be"too stressful for you, the regulations say that 24 you don't have to tell them, except for the responsible 25 relative.
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I 97 1 DR. SIEGEL: Which.is a mess, because the current 2 interpretation of the responsible relative issue means that 3 you can't get out of notifying because you think it will 4 actually harm the patient. It has to also harm the 5 responsible relative.
'6- DR. CERQUEIRA: I think these points have been 7 made in previous meetings. Pretty much the Commissioners 8 are somewhat concerned about this, because they don't want 9 to give the appearance of covering up anything by not 10 notifying patients. I think the committee feels very l 11 strongly that we do need to make this point, and we will 12 reiterate it.
13 Dennis.
14 MR. SWANSON: One comment about your alternative j 15 rule language. You have a regulatory requirement to notify 16 the patient and you have a regulatory requirement to notify 17 the referring physician. but you only have to certify that I 18 you notified the patie:.c. I hate to add additional 19 certifications, but it doesn't make sense why you wouldn't 20 also certify that you informed the referring physician if i
21 that is part of the regulatory language. The current !
i 22 language focuses on the problem, which is the patient 23 notification issue. ,
24 MS. HANEY: Probably (vii), certification that the 25 licensee notified the referring physician and the
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98 11 individual'.
2 DR. WAGNER: I would actually word it entirely 3~ differently. I'd say that you certify that you complied
~
L4- with item.E, period.
5 MR. SWANSON: .You could do that, too.
6 DR.. WAGNER: 'That takes everything out of there.
7 .That you complied with item E. That way you might-not have 8 notifiedLthe' patient because the referring physician may 9 have said,. don't do this, she's.too high strung right now, 1G I this is going:to be too much of a problem. I'll take care 11 of;it. .
12 MS. HANEY: Lou, - don't think that would be an 13 ' issue to change.that, but I think the issue is whether we 14 would accept' certification at all.
15 DR. WAGNER: Is the committee' going to take a 16- stand on this? I.would vote that the committee agree with 17' the. alternative ruling with regard to notification, with the 18 requirement that the licensee certify that item E has been 19 complied with.
=20 DR. CERQUEIRA: Right, and the referring physician 21 and: individual have been notified.
22 DR.-WAGNER: By saying-item E you have already 23l said that you have carried it out. With that change in,the 24 -phraseology to indicate that the certification will simply 25~ z state-that the licensee complied with item E, I would move l
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1 that the committee endorse that change as a potential l
l 2 alternative to our original position.
l 3 DR. CERQUEIRA: Do we have a second? I guess
~4 there are only four voting members here presently. Does 5 that constitute a quorum?
6 MS. HANEY: Yes, because we are down so low on the 7 members.
8 MS. HOBSON: I'll second.
9 DR. CERQUEIRA: Any further discussion?
10 MS. McBURNEY: Although I did abstain on the 11 position that the advisory committee took not having that 12 notification be done at all, I could support this 13 alternative language. I think it still gets at a rule that 14 says that you will notify. It is just a different way. of 15 doing it.
16 DR. CERQUEIRA: All those in favor of supporting 17 the alternative rule text, as modified.
18 MS. HOBSON: I guess I shou _d make one final 19 comment. I haven't change my position that I think patient 20 notification in general is a lousy idea. The alternative is 21 def sitely better than what is in the current draft. So 22 reluctantly I would support this. If we have to say one or 23 the other, then I would say this.
24 DR. CERQUEIRA: All those in favor.
25 [Show of hands.]
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100 1 DR. CERQUEIRA: It's unanimous.
2 DR.' WAGNER: Did you vote,. Dennis?
3 MR. SWANSON: I can't vote.
4 DR. CERQUEIRA: He's not a. voting member. There 5 are only four voting members, Lou.
6 MR. SWANSON: If you want my opinion, I think what
-7 you'ought to do is restate the previous position of the 8 ACMUI.
9 i DR. CERQUEIRA: Do you want me to do that during "10 the presentation?
11 MS. HANEY: I think during the presentation you 12 should say.that the ACMUI continues to believe that there 13 should be no requirements for patient notification, and it 14 is up to you if you want to go on at that point and say, 15 however, if there are going to be notification requirements,
.16 we support the alternative rule text over tnat which is in 17 the existing rule, and then just go on at that point to the 18_ 'next viewgraph. That will come back as a discussion.
19 DR. CERQUEIRAi The version that they have is 20 different than what we have approved.
21 MS. HANEY: I wouldn't worry too much about that, 22 because that level of specificity is something that I can 23 work with. When the staff requirements memorandum comes
'24 down, I can do that informally.
25 ' DR . CERQUEIRA: It-sounds good.
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4 101
_ 1 The last two are the implementation challenges.
2' MS.lMcBURNEY: You already talked about'early 13 recognition.
4 MS..HANEY: You may.get a question on the guidance f
-St- document and about your review of it. I.got a question:
did the ACMUI review it?: I said that you had seen the early
~
6 7 ' drafts of it, but it has changed significantly since then 8- because_the rule has changed significantly again. '
- 9. You might want to spend.a couple minutes talking 1
10 about if asked, committee, do you want to review the
{
11 guidance document again, what your response to it woulf be. l 12
)
We all know.it, but a lot of this-is to cet it on the '
~ 13 . record. The guidance document should not be used to i
14 . implement de facto regulation." Those are some words you
- 15 might want to-get out.
16: You think that there is a benefit.to having model 17 procedures out there for licensees'that are lf.ss
- 18 Lsophisticated than some of the'other licensees, some of the 19- . larger licensees. However, you believe the NURSG should be
. 20 as flexible as possible to allow-use of multiple different 21 types of procedures.
22' EThose are some of the things that you might want 23' to spend a couple minutes talking.about if asked. ,
i 14 DR. CERQUEIRA: .Okay.
' 25 .When will'this document be coming out?
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. ....i 102 1 MS. HANEY: You're not going to see it for another 2 three, months. We haven't worked on it because we want the 3 rule finalized before we make any mere changes to the NUREG 4 document.
l 5 The draft that went out, we went through it as I l
6 carefully as we could given the time constraints to make l 9 sure there were no de facto regulations in there We still 8 got criticism that we were using the NUREG as a de facto l 9 regulation. .
10 A lot of that had to do with just interpretation i
11 how to use it. We use the terms "should" and "shall." If 12 we use the term someone "should" do something, that means 13 it's a nice idea but you don't have to, there is no 14- regulatory requirement to do it. If we say the licensee
- 15 "shall" do something, then there is a regulatory tie for it.
16 I think a lot of the comments that came back is i
j 17 people just didn't understand the diff rence but we have
! 18 got that in the verbiage up front, the difference between i l l 19 the use of the terms.
20 Our plan is to broaden it a little bit more with 21 the model procedures than what went out with the proposed l 22 rule.
l l
23 DR. CERQUEIRA: Lou.
i 24 DR. WAGNER: I have a question with regard to the 25 ismue of enforcement and the fact that a mind-set change is l
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1 going to be required to be able to adequately enforce these 2 rules.because'of their lack of prescriptiveness now. It is 3 performance based. That is going to be a difficult-i 4 challenge for the NRC'and also for the Agreement States..
5 I can't predict what is going to happen, but I L 6. guess.one.of the-pet' peeves I have with regard to some of 7 the' enforcement regulation is that when you write your
- 8. policies and procedures about how-you are going to do things 9 and then a regulatory comes in and says, well, you didn't do 10 _it exactly the way you say right here, you didn't use this 11- disinfectant, you used this other disinfectant, but that's 12 against your policies and procedures, so here is a citation 13 because you didn't follow your policies and procedures.
14 That has happened.
15' It is that kind of thing that becomes a problem.
'16 Now we have this flexibility in here, and you are being held 17 to a different kind of' standard. What we have to really 18- reinforce'to.the Commission is the challenge it is going to 19 be for enforcerent to be ablei to look at the performance and 20 based it just on perfo$mance and not into the nit-picking 21 issues with. regard to what is on paper, what are we writing 22: down here, and all these other issues.
23 This is where we have got to emphac' Se that. . I l
24~ thinke Manny, we have got to come in and discuss that with 25 them. -They=have a big task ahead of them here. This is not !
l l
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... a 104 1 going to be a small task.
2 MS. HANEY: This is a good place to pitch 3 continued ACMUI involvement with inspection procedures.
4 DR. WAGNER: The use of subcommittee would be 5 wonderful with this.
6 MS. HANEY: This is the place to pitch it.
7 Continued employment for ACMUI.
8 [ Laughter.]
l DR. CERQUEIRA:
9 Not that they need it.
10 Ruth.
11 MS. McBURNEY: We had our annual meeting with the .
12 regional Nuclear Regulatory Commission state p'ogram staff j 13 yesterday. They were stating that they are already 1 14 implementing a pilot program for performance-based 15 inspections in the medical area.
16 No?
17- MS. HANEY: No. We're not doing it yet. It has I 38 not been approved yet.
j 19 MS. McBURNEY: Okay. They told us wrong. j 20 MS. HANEY: Unless they were talking about some i 21 other program. We have considered doing a pilot program in 22 the medical area that would focus on performance where the 1 23 inspector would go in and look at big picture things, were .
24 there misadministrations, were there overexposures. That 25 has not been approved by the Commission yet. They signed ANN RILEY & ASSOCIATES, LTD.
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I l 105
. 1 ~o ff on it, but it hasn't made it to the Commission.
2 Actually, we started it back in January of last
! 3 year. We had a meeting with regional inspectors and came up 4 with what the criteria should be. Then we held a public ,
1 5 meeting on it. I think it was January, because I couldn't 6 come because I was snowed in. We discussed the issues with {
7 the public that came and then further refined it. Just 8 becauce of different changes in the paper and everytning it 9 has nc* g; 7e to the Commission. !
10 It ties in ve:ry much to what Lou is saying, but it 11 is the going in, looking at the big picture thing, not 12 getting down at the nitty-gritty unless there is cause to.
13 The classic would be the procedures for written directives.
14 If we are investigating a misadministration or a medical 15 _ event, we are going to ask to see those procedures. Then we 16 may say, you said you are going to do this and this and you 17 didn't do it, and then more than likely there is a going to 18 be a violation.
19 On a routine basic in a medical facility,'we are 20 not going to go in and say, let me see those procedures. We 21 might say, do you have them, and then say, great, and then 22 just not even nsk to see them.
23 Ic is a different mind-set, but this is a very 24 difficult change for the program. If you want to go so far 25 as the ACMUI wants to work closely with the implementation ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
l
i-106 1- .ofs the rule,~there;are a1 lot of challenges with this. Our 2 . plan..isfoncelwe get further along we_will go out and do 3" . training with the license reviewers and the inspectors 4 Hopefully, once the-violations start coming in-we will
- 5. _scrutinizejthingslmore than we would~for a normal sort of violation ^.
~
'6 7 It's a-big change, but it's the way NRC is going.
O Notfjust in the medical. area, but in all areas.
4 9 DR.-CERQUEIRA- We are pretty close to our ending 10- time. We have gone through pretty much all of the
- 11. ~ viewgraphs-that Cathy is going to go over and that I will 212 present.and then take questions and direct it to our experts 13 from the panel.
14 Any'other points?
15 Lou.
'16 DR. WAGNER: Can we, address with the Commission 17 perhaps the issue of membership of this committee and the 118 filling of the positions in a timely manner, and just at-19 least get our point across that this seems to be a chronic, 20 nagging problem'that has not gotten solved over'the-years 21 :although.it has been an obvious problem and we have brought 12 2 . it to'their attention?
- 23 If vur could address that issue, I would just ,like 2 4 -. to.know that the Commission is awareLthat there is a problem 25 here withLgetting.these positions filled.in a timely manner 0'
a ANN RILEY &-ASSOCIATES,' LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite-1014 Washington, D.C. 20036 -
n y - .(202) 842-0034
107 1 and having people and repretientation on this committee.
2 This committee works real well when you have got full 3
rep,resentation, but if you don't and you have a certain key 4
person absent and they are not there because there is nobody 5 filling that position, the voting ability and the consensus 6 ability, everything just deteriorates.
7 DR. CERQUEIRA: I think those are good points. I 8 guess just trying to politically decide whether this is the 9 forum to do it or not is something.
10 Barry, what do you think? You've been through 11 these things more than any of us. Is this the right place 12 to bring it up? Can you do it incorrectly?
13 DR. SIEGEL: It depends a little bit whose head is 14 going to roll once they realize that -- I probably wouldn't.
15 If you are going to do it, I would do it right at the 16 beginning. I'd say, you know, there are only four of us 17 here today, and let me tell you why. '
18 I wouldn't. I'd save it for a different forum, 19 differer time. I think you need to stay focused right on 20 Part 35.
21 DR. CERQUEIRA: That is what I worry about. We 22 have got this evaluation process which has been instituted.
23 MS. HANEY: I will put it in the self-ecaluat. ion.
24 How about that?
25 DR. WAGNER: That's good.
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108 1 MS. HANEY: That is going to the Commission. So 2 .we'll get it in there.
3 DR. WAGNER: That's great.
4 DR. CERQUEIRA: I think it would sort of diffuse 5 the issue a little bit.
6 If there are no other comments,. we will and 7 exactly on. time.
8 Dennis.
9 MR. SWANSON: I have specific comments on the 10 draft language, but I will just point them out to' Cathy and 11 you can take it from there.
12 MS. HANEY: If Barry doesn't split, we can look 13 at.
14 DR. WAGNER: Do we need a motion to adjourn?
15 DR. CERQUEIRA: Yes.
16 .DR. WAGNER: So moved.
17 DR. CERQUEIRA: We are officially adjourned.
18 [Whereupon at 5:00 p.m., the meeting was 19 concluded.]
20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
.,e._,
-REPORTER'S CERTIFICATE
-This is to certify-that the attached proceedings before-the United. States Nuclear Regulatory Commission in the' matter of:
'NAME OF PROCEEDING:
' ADVISORY' COMMITTEE ON THE MEDICAL USES OF IOSTOPES (ACMUI).
. CASE NUMBER:
.,: 'j l
' PLACE OF PROCEEDING: Rockville, MD were held.'as-herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission-taken by me and thereafter' reduced to typewriting by me or under the direction of the court reporting company, and that'the transcript is a true and accurate-record'of the foregoing proceedings.
/ btO,M
' ~
Mike Paulus V' Official Reporter ,
Ann Riley & Associates,-Ltd.
v 8 f
MEMBERS OF'THE PUBLIC SIGN IN SHEET
.(DO NOT REMOVE THIS: FORM)
'ACMUI Meeting
' October 20, 1999 U.S. Nuclear Regulatory-Commission,.Two White Flint North,;T2B3 Please print: legibly, as this is a public document MEME NAME bbab < .$ m tr. a.-
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