ML19115A409
| ML19115A409 | |
| Person / Time | |
|---|---|
| Issue date: | 04/25/2019 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson K | |
| References | |
| NRC-0262 | |
| Download: ML19115A409 (83) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI), Day 2 Docket Number: N/A Location: Rockville, Maryland Date: April 4, 2019 Work Order No.: NRC-0262 Pages 1-83 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
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SPRING 2019 MEETING
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THURSDAY, APRIL 4, 2019
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The meeting was convened in Room 1-C03/1-C05, Three White Flint North, 11601 Landsdown Street, Rockville, Maryland, at 8:30 a.m., Christopher J.
Palestro, ACMUI Chairman, presiding.
MEMBERS PRESENT:
CHRISTOPHER J. PALESTRO, M.D., Chairman DARLENE F. METTER, M.D., Vice Chairman VASKEN DILSIZIAN, M.D., Member RONALD D. ENNIS, M.D., Member RICHARD L. GREEN, Member MELISSA MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member ARTHUR SCHLEIPMAN, Ph.D., Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member LAURA M. WEIL, Member NON-VOTING MEMBER PRESENT:
HARVEY B. WOLKOV, M.D.
NRC STAFF PRESENT:
CHRIS EINBERG, NMSS/MSST/MSEB, Branch Chief, Designated Federal Official MARYANN AYOADE, NMSS/MSST/MSEB/MRST LAURA CENDER, R-III/DNMS/MLB SAID DIABES-FIGUEROA, NMSS/MSST/MSEB/MRST LISA DIMMICK, NMSS/MSST/MSEB/MRST, Team Leader SARA FORSTER, R-III/DNMSS/MLB CASSANDRA FRAZIER, R-III/DNMS/MLB ROBERT GALLAGHAR, R-I/DNMS/MLAB SOPHIE HOLIDAY, NMSS/MSST/MSEB ESTHER HOUSEMAN, OGC/GCRPS/RMR DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB/MRST IAN IRVIN, OGC/GCRPS/RMR KELLEE JAMERSON, NMSS/MSST/MSEB, ACMUI Coordinator ERIN KENNEDY, R-III/DNMS/MLB PENNY LANZISERA, R-I/DNMS/MLAB NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 ROBERT MACDOUGALL, NMSS/DRM/MRPB SCOTT MOORE, NMSS, Deputy Director JANICE NGUYEN, R-I/DNMS/MLAB DENNIS ODOWD, R-III/DNMS/MIB PATRICIA PELKE, R-III/DNMS/MLB DAVID PELTON, R-III/DNMS ALEXA SIERACKI, NMSS/DRM/MRPB KATIE TAPP, Ph.D., NMSS/MSST/MSEB KEVIN WILLIAMS, NMSS/MSST IRENE WU, NMSS/MSST/MSEB MEMBERS OF THE PUBLIC:
DANNY ALLEN, NuTech, Inc.
ERIC ANDERSEN, Dana-Farber Cancer Institute KENDALL BERRY, Fox Chase Cancer Center BETTE BLANKENSHIP, American Association of Physicists in Medicine (AAPM)
MARY BURKHART, Illinois Emergency Management Agency ASHLEY COCKERHAM, SirTex Medical JASON COLLIER, Lehigh Valley Health Network WHITNEY COX, Illinois Emergency Management Agency WILLIE (JACK) CRAWFORD, Virginia Office of Radiological Health NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 LYNNE A. FAIROBENT, Unaffiliated SHERRIE FLAHERTY, Minnesota Radioactive Material Unit MICHAEL FULLER, Virginia Office of Radiological Health MATTHEW HADDEN, Virginia Office of Radiological Health MATTHEW HALL, NorthShore University Health System STANLEY HAMPTON, Eli Lilly PAUL KANABROCKI, Virginia Office of Radiological Health HEATHER KARMANSKY, SirTex Medical RALPH LIETO, St. Joseph Mercy Health Center JEFF MASON, Virginia Office of Radiological Health STEVE MATTMULLER, Kettering Health ANDREW McKUSICK, Unknown ASHLEY MISHOE, University of California, San Francisco JOSHUA MYERS, Pennsylvania Department of Environmental Protection SCOTT NEMMERS, U.S. Air Force MICHAEL PETERS, American College of Radiology BRAD PRICE, GE Healthcare NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 EUGENIO SILVESTRINI, Northwell Health LAKSHMI SIVASUBRAMANIAN, University of Massachusetts Medical School DIANA THOMPSON, University of Illinois at Chicago WILLIAM WHITE, Rush University Medical Center NEIL WHITESIDE, Yale New Haven Hospital MATTHEW WILLIAMS, Georgetown University MATTHEW WILLIAMSON, Memorial Sloan Kettering Cancer Center ROBERT WILSON, University of Tennessee Health Science Center NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 TABLE OF CONTENTS Page
- 11. ACMUI Reporting Structure Kellee Jamerson............................7
- 12. Special Presentation to Ms. Weil Scott Moore................................32
- 13. Thoughts on Leaving the ACMUI Laura Weil................................35
- 16. ACMUI Bylaws Subcommittee Report Laura Weil.................................47 16(a) Establishment of Subcommittee to Improve the ACMUI's Institutional Memory Chairman Palestro...........................68
- 17. Open Forum Chairman Palestro...........................69
- 18. Administrative Closing Kellee Jamerson............................74
- 19. Adjourn Chairman Palestro..........................83 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 P R O C E E D I N G S 2 (8:31 a.m.)
3 CHAIRMAN PALESTRO: All right, good 4 morning. We're getting ready to start Day 2 of the 5 ACMUI Spring 2019 meeting. And the first session on 6 today's agenda is the ACMUI reporting structure and it 7 will be reported by Ms. Kellee Jamerson.
8 MS. JAMERSON: I will be giving the annual 9 presentation on the committee's reporting structure.
10 So our outline for today includes the 11 current reporting structure. This presentation will 12 serve as your annual review. We will discuss how 13 often we conduct our meetings and then open it up for 14 a discussion.
15 This chart shows the organizational 16 structure within the NRC from the Division of 17 Materials Safety, Security, State, and Tribal 18 Programs, up to the Commission.
19 The ACMUI reports directly to Ms. Andrea 20 Kock, Director of the Division of Materials Safety, 21 Security, State and Tribal Programs.
22 My branch, the Medical Safety and Events 23 Assessment Branch also reports to Ms. Kock.
24 While the ACMUI does not report to the 25 Medical Safety and Events Assessment Branch or MSEB, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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8 1 MSEB is responsible for supporting the day-to-day 2 activities of the committee.
3 The dotted lines, as you see on the left, 4 indicate that while you may report to Ms. Kock or 5 Kevin Williams, our Deputy Division Director, this 6 does not preclude you from communicating or 7 interacting with the Director of our office, the 8 Office of Nuclear Material Safety and Safeguards or 9 our Executive Director of Operations, or to the 10 Commission.
11 In September 2012, as indicated on the old 12 business chart, the ACMUI recommended to have an 13 annual review of the reporting structure open 14 indefinitely. In May 2014, the Bylaws Subcommittee at 15 that time presented the committee with the option to 16 continue reporting to NMSS or directly to the 17 Commission.
18 The subcommittee report stated that the 19 working relationship between the NRC and the ACMUI 20 remains excellent. The reporting structure, through 21 NRC staff, continues to function effectively and the 22 associated logistical overhead associated with direct 23 reporting to the Commission did not and does not now 24 justify any change in the ACMUI's reporting structure.
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9 1 of the reporting structure.
2 Currently, the ACMUI holds two meetings at 3 NRC Headquarters each year. The spring meeting takes 4 place in either March or April and the fall meeting 5 occurs in September or October.
6 The ACMUI also has approximately two to 7 three teleconferences per year, as needed. We have 8 already conducted one teleconference on February 26th 9 and we will likely have two more this summer to 10 receive the committee's comments on the staff's draft 11 commission paper related to the training and 12 experience requirements and the draft revisions to 13 Regulatory Guide 8.39.
14 As you can see, the number of 15 teleconferences varies, depending on the needs of the 16 committee, as well as the needs of the staff and the 17 Commission.
18 At this point, I would like to open it up 19 for discussion to the committee and, for your 20 consideration, these questions for you to discuss.
21 Do you still agree with the current 22 reporting structure where the ACMUI reports to the 23 MSST management or would you rather report directly to 24 the Commission?
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10 1 the meetings; that is, two in-person meetings here at 2 NRC Headquarters, with as-needed teleconferences?
3 And lastly, are there any other changes 4 that you would like to see?
5 I will turn it over to Dr. Palestro.
6 CHAIRMAN PALESTRO: Dr. Metter?
7 VICE CHAIRMAN METTER: Thank you, Kellee.
8 Do you mind going back to that chart? You 9 have the directors and I know you probably know who 10 they are but can you give us their names so we know --
11 can identify a name with the position?
12 MS. JAMERSON: Sure. John Lubinski is the 13 Director of NMSS, whom you met yesterday.
14 The Director of MSST is Andrea Kock. She 15 could not attend. Our Deputy Director is here, Kevin 16 Williams.
17 Our Executive Director of Operations is 18 Margaret Doane.
19 VICE CHAIRMAN METTER: Okay, thank you.
20 CHAIRMAN PALESTRO: Other 21 questions/comments?
22 I have a question regarding the reporting 23 structure. The way it is designed, we report up 24 through various levels. What would be the advantages 25 or disadvantages of changing that reporting structure?
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11 1 Because I certainly have no idea.
2 MS. HOLIDAY: Okay, so this is Sophie 3 Holiday, for those listening on the webinar.
4 So currently we have three Federal 5 Advisory Committees or FACA Committees here at the 6 NRC. The one that everyone is most familiar with, 7 aside from our committee here, is ACRS, which is the 8 Advisory Committee for Reactor Safeguards. And that 9 is the only FACA committee here at NRC that reports 10 directly to the Commission.
11 So because they report directly to the 12 Commission, they have their own office, if you will, a 13 dedicated staff that helps them because they generate 14 a lot of letter reports, as I understand it. They 15 meet here at headquarters at least ten times a year 16 for in-person meetings and also subcommittee meetings 17 in-between or also during those ten meeting times a 18 year.
19 Honestly, reporting directly to the 20 Commission versus reporting through the division, 21 through our division, MSST, is not necessarily very 22 different in terms of if you feel the ACMUI wants to 23 have access to the Commission, the dotted lines from 24 ACMUI to the Director of NMSS, to EDO, or to the 25 Commission simply means that we have an open door NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 policy.
2 Maybe a couple of the members on the 3 committee may remember at one time our previous 4 chairman, I believe it was Dr. Thomadsen, scheduled 5 drop-in meetings with the Commission, particularly, he 6 held them the day before the ACMUI meeting when it was 7 convenient because he was in town at that time. At 8 any other time, any member here on the ACMUI can 9 request to have a meeting with any of our 10 commissioners, or the EDO, or any of our levels of 11 management.
12 In terms of the disadvantages, I think one 13 of the reasons, as I recall from the paper that Kellee 14 referenced before, the reason that the committee had 15 previously stated that they wanted to retain the 16 current reporting structure, that is, to report 17 through our division and our office, is that it would 18 be less frequent meetings, not to say that you would 19 not be as visible to the Commission but you would not 20 be as demanded of, if that makes sense.
21 Because a lot of our rules and our 22 regulations here at the NRC are very much so centered 23 around nuclear reactors, that is why that particular 24 FACA Committee meets as frequently as they do, 25 produces as many reports as they do. Their reports do NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 go straight to the Commission; whereas, for the 2 committee, any subcommittee report that you submit and 3 it ties into any policy changes that the NRC staff is 4 pursuing, we append your unfettered comments, which is 5 your report to our SECY papers, to our memorandums, to 6 our Commissioner Assistant notes, so that they are 7 able to hear verbatim what the committee has said.
8 Hopefully, that answered your question.
9 CHAIRMAN PALESTRO: Yes, it does. Thank 10 you.
11 MS. HOLIDAY: Thank you.
12 CHAIRMAN PALESTRO: Any other questions or 13 comments? Ms. Weil.
14 MEMBER WEIL: As the historian, I guess, 15 on this committee, when I first came on there was some 16 question about why an annual review. Why can't we 17 just settle on how we function? And the reason I was 18 given, and this occurred before my time, before 19 Kellee, before Sophie, before Ashley, there was some 20 dissatisfaction on the ACMUI with the staff support 21 that we had.
22 And so there was a decision made to 23 annually review whether we are content with the 24 support that the committee is given and whether we 25 want to continue in our current organizational NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 structure.
2 I just thought I would offer that 3 perspective.
4 CHAIRMAN PALESTRO: Thank you.
5 Any other comments or questions?
6 Is there a general consensus that we are 7 content with the structure, recognizing that many of 8 you are new on the committee and haven't had a lot of 9 experience with it?
10 Dr. Ennis.
11 MEMBER ENNIS: Just my personal opinion, I 12 am content. Actually, overall, content in this part 13 of my life.
14 (Laughter.)
15 MEMBER ENNIS: You know over the years 16 that I have been on, the NRC staff has been fabulous.
17 I do have, as I expressed a little bit 18 yesterday, though, a little bit of a concern about 19 whether they have enough support. I don't know if, 20 personally, I am at a point where I feel like we need 21 to do something about it because there have been some 22 additions with Kellee and a new position. So 23 personally, I may be willing to kind of give it 24 another six months to a year. But even with that 25 issue, I don't think that is so much about structure NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 but it may be about whether we need to have a meeting 2 directly with someone higher up on the chain.
3 CHAIRMAN PALESTRO: Zoubir.
4 MEMBER OUHIB: I would just like to echo 5 what Dr. Ennis just said. I really believe that there 6 is still need for more support for the staff in order 7 for the ACMUI to actually accomplish what we want to 8 accomplish. There are other things that we probably 9 could tackle but I think knowing that the staffing is 10 probably not ideal, we tend to back up rather than try 11 to push.
12 CHAIRMAN PALESTRO: Thank you.
13 Any other comments?
14 Mr. Einberg?
15 MR. EINBERG: This is Chris Einberg.
16 In regards to the staff support, in the 17 past year or so, there have been challenges with the 18 backfilling for some people that were out. I think we 19 are righting the ship in that regard. And so we are 20 putting priority and trying to -- we are going to put 21 an additional priority on closing these open items.
22 We heard you yesterday and we will make that a 23 priority to close some of these open items.
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16 1 additional resources. We have the flexibility to try 2 to bring on people on rotations and details to help 3 close some of these action items. So we will work 4 those issues to try to close those action items and 5 get the support you need.
6 Other than the open items, is there 7 anything else that you feel that there is additional 8 support needed?
9 CHAIRMAN PALESTRO: Dr. Ennis?
10 MEMBER ENNIS: I don't have a specific 11 thing but, as Mr. Ouhib just mentioned, we do, or at 12 least I feel like we function a little bit with a 13 cloud over our heads -- well, don't ask for too much 14 or don't try and do too much because the staff can't 15 do that. That's not really an ideal way for ACMUI to 16 function.
17 MR. EINBERG: I'm not sure I understood 18 the comment. Perhaps you can rephrase it.
19 The staff is asking you not to do too 20 much?
21 MEMBER ENNIS: No, it's just that we get a 22 feeling. Like because things take a long time and 23 occasionally, there will be comments like within our -
24 - we will tackle that within our resources.
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17 1 budget, and a federal deficit, and all of that but it 2 feels a little bit like, in such a big organization, 3 to have such limited resources isn't a good balance.
4 And it feels just like it is something that we have to 5 always be aware of; you can only do a little bit.
6 MR. EINBERG: Okay.
7 MR. WILLIAMS: So also, if I may, this is 8 Kevin Williams, the Deputy Director.
9 So those types of activities, and I know I 10 can speak on behalf of Andrea, she wants to be aware 11 of those types of activities. We are constantly 12 looking at our workload, and analyzing it to see how 13 best to support all of the things that we are doing.
14 I certainly wouldn't want you to feel as 15 though there is a cloud or we are limited in terms of 16 what we can do. So, we would like you to bring those 17 types of things up to us. You can work through 18 Kellee, and Chris, and so forth but we will address 19 what we can but we can't necessarily address what we 20 don't know.
21 And so I appreciate your candor and I 22 would ask that you continue to push and let us know 23 where the challenges are because we will identify 24 those.
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18 1 talked about was the plans and the activities that we 2 have committed to. Chris and I talked offline and 3 that was one of the things that we said we wanted to 4 make sure we have a plan with a milestone and 5 schedule. So that is one thing that we know that is 6 tangible and that we can actually address.
7 So I would look forward to continue 8 engaging and letting us know where there are areas 9 that we can enhance the program.
10 MEMBER ENNIS: That's great. I appreciate 11 it.
12 Just to be clear, the individuals with 13 whom we work are fabulous. It is not meant at all as 14 a criticism of the current staff that we have.
15 MR. WILLIAMS: No, I know that.
16 CHAIRMAN PALESTRO: Dr. Metter.
17 VICE CHAIRMAN METTER: Thank you, Kellee.
18 And this may be a very minute question but 19 you know when we talk to NRC staff and then you say 20 you have to clear it with management, who is that?
21 Oh, okay. Thank you, Kevin. Okay.
22 CHAIRMAN PALESTRO: Zoubir.
23 MEMBER OUHIB: Just to echo Dr. Ennis 24 again is that I just want to make sure this is clear.
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19 1 all honesty. Because again, they are great, very 2 accommodating and will do whatever they can. It is 3 just more like us, at least from my point of view, us 4 looking at the whole program and try to see well, yes, 5 we could look into this, we could look into this but 6 can we really do it? Listen to what they are dealing 7 with and what they have to meet, and so on and so 8 forth. So we tend to well, let's just wait a little 9 bit and then maybe we can address this or we can 10 address that.
11 I mean ideas come and go and we are like 12 maybe next year, whatever. So I just want to make 13 sure it is not coming from them. It is us looking at 14 it.
15 MR. WILLIAMS: Yes, so hows I would 16 respond to that is I want to go on the record as 17 saying I think Sophie and Kellee do a great job. They 18 are amazing and they work diligently to make sure that 19 this program runs at a high-functioning level.
20 So I would want to reiterate is the fact 21 that the whole purpose of this is to take that 22 critical look at the program, the processes, and to 23 say hey, is there something that we can do better. We 24 wouldn't want you to feel as though you were limited.
25 So there are things that you are thinking about.
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20 1 Let's talk about those things because in talking 2 through them, we can develop plans. We can look at it 3 and see if there is a way to do it.
4 We don't necessarily have to move at a 5 snail's pace but if you are bringing those issues up 6 to us, we are aware of what they are and we can take 7 some sort of action.
8 CHAIRMAN PALESTRO: Any other comments or 9 questions from the committee? Mr. Fuller.
10 MR. FULLER: Yes, this is Mike Fuller and 11 I am the Director of the Virginia Radioactive 12 Materials Program but I have some experience.
13 So again, to bring a little bit more of an 14 historical perspective, I guess, one thing that hasn't 15 been mentioned and I know everybody knows this, but 16 just so that the new folks on the ACMUI are also 17 aware, there is another big difference between the 18 ACRS and the ACMUI.
19 The ACRS reports directly to the 20 Commission, yes, and they have certain areas of 21 expertise. Each of the members are you know highly 22 specialized in what they do. But the NRC staff has, 23 possesses all of those skills, all of that knowledge, 24 and that experience, and so forth, the same sort of 25 specialists. So it works for the ACRS to report NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 directly to the Commission because the staff has the 2 exact same expertise, or at least very similar 3 expertise.
4 What is different and one of the reasons 5 why the ACMUI reports to staff is because this 6 committee comprises and has certain technical, 7 medical, clinical expertise that the staff does not 8 have. So this committee advises the staff because the 9 staff does not have what you have as far as experience 10 and expertise.
11 So that is another reason why this 12 committee reports and supports the staff, as opposed 13 to the Commission, because if you reported directly to 14 the Commission, the Commission would not have another 15 -- so with the ACRS, the Commission can hear from the 16 Advisory Committee can also hear from staff and get 17 maybe two perspectives, or maybe a different nuanced 18 perspective. Whereas, if you reported directly to the 19 Commission, the staff has nothing to offer.
20 So anyway, I just thought I would add 21 that. Like I said, I think that is sort of in the 22 back of everybody's mind but it just didn't come up in 23 this discussion and for the benefit of the newer 24 members on the ACMUI.
25 So thank you.
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22 1 CHAIRMAN PALESTRO: Thank you.
2 Any other comments or questions?
3 One item that I think comes up 4 periodically is the number of face-to-face meetings 5 per year. So I would ask if the committee has any 6 thoughts on that.
7 As you all know, we meet twice a year; 8 fall and spring. And the discussion has come up 9 periodically as to whether or not a third or fourth 10 face-to-face meeting could potentially be useful or 11 necessary. So I am just putting that out for a 12 discussion and comment.
13 Dr. Ennis.
14 MEMBER ENNIS: It looks like there are so 15 many new members who can't really offer an opinion on 16 that so, I will speak up that I think it is an 17 appropriate balance. It feels to me twice a year is 18 good -- is the right amount.
19 CHAIRMAN PALESTRO: Yes, this question 20 comes up periodically at these annual reviews and it 21 has generally been a consistent response that while an 22 additional face-to-face meeting or two might be 23 desirable, the logistics involved and so forth far 24 outweigh any benefits. And that at least at the 25 present time, and again, we have the opportunity to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 review it annually.
2 The two face-to-face meetings, 3 supplemented with a sufficient number of telephone 4 conferences during the year are sufficient to complete 5 our business.
6 Any other comments? Zoubir.
7 MEMBER OUHIB: Yes, I think biannual is 8 probably sufficient. However, with the emerging 9 technology and things that we are all going to be 10 dealing with in the very near future, perhaps to sort 11 of not necessarily say okay, let's do it three times 12 or something like that, but be flexible and have the 13 ability to add another face-to-face meeting to sort of 14 deal with urgent matters that will come along.
15 CHAIRMAN PALESTRO: All right, thank you 16 for that.
17 Maryann.
18 MS. AYOADE: Yes, Maryann, NRC member.
19 I just wanted to add that we do have 20 opportunities where if the ACMUI members feel that 21 they need additional face-to-face, we can try to 22 accommodate that.
23 For example, last year with the T&E 24 Subcommittee, Dr. Metter asked for a face-to-face 25 working day with the subcommittee a day before the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 meeting. And we were able to accommodate that. And 2 that worked with people's schedules because they 3 didn't have to plan a separate visit outside of the 4 two annual or the two times you guys come in in the 5 year.
6 And I don't know, historically, if, 7 Sophie, this has been done before but we were able to 8 accommodate that. So that might be something that 9 some of the members may want to consider if they think 10 a face-to-face meeting would benefit their 11 subcommittees in moving forward.
12 MS. HOLIDAY: Hi, Maryann. Thank you for 13 that input.
14 And Maryann is quite correct. We did do 15 that last year for the T&E Subcommittee. For the time 16 that I have been with the committee, has been roughly, 17 oh, gosh, nine years, I can only remember maybe one or 18 two other instances where we brought members in a day 19 before the meeting. And that was really more so to do 20 the Commission dry run because, at that time, the 21 Commission meeting was on Day 1 of the ACMUI meeting 22 versus Day 2.
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25 1 does cost quite a bit of money and our members are 2 scattered across the country, you know we would do our 3 best to support you in those efforts.
4 With respect to what Mr. Ouhib said 5 regarding emerging medical technologies and I believe 6 the word you used was urgent, I personally find that 7 with urgent matters, an ad hoc teleconference is a 8 better approach in terms of it allows you a little bit 9 more flexibility, members are able to set aside two --
10 you know one to three hours. I think our longest 11 teleconference has been three hours for a given topic 12 or two topics.
13 The reason that we have these in-person 14 meetings twice a year is because it covers several 15 different topics. So unless, for example, the 16 emerging medical technologies, if that had evolved 17 into numerous agenda topics where it could cover a day 18 or two, I think NRC would be very supportive of that.
19 But like we said, we are flexible. It 20 hasn't happened yet but if it does come to that point, 21 I don't see an objection.
22 I see nods from the management.
23 CHAIRMAN PALESTRO: Any other comments or 24 questions? Dr. Dilsizian.
25 MEMBER DILSIZIAN: Thank you.
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26 1 I guess my observation over the last three 2 or four years now, is that I don't see any issue of 3 ACMUI coming up with an agenda and recommendations.
4 The reason I think we don't need more than two is 5 because a lot of our recommendations don't actually 6 become reality for several years.
7 So I don't understand what the urgency 8 would be because I feel like I have been on this 9 committee, this is my fifth year, a lot of things that 10 we have discussed, that we have proposed, or 11 recommended, we are still very active and nothing is 12 happening. So to me, the urgency of doing more 13 meetings would be if those actually become actionable 14 items.
15 So we can talk all we want to. We can 16 present all these nice ideas but I think that there 17 doesn't seem to be urgency from the NRC. So we can 18 just only advise but it doesn't seem to be moving 19 forward.
20 So that would be my comment.
21 CHAIRMAN PALESTRO: Thank you. I'm 22 inclined to agree with you. Certainly at the moment, 23 it is hard to identify something that is urgent and 24 there is no way to know about urgency looking into the 25 future. On the other hand, I think it is nice to know NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 or to have the sense that if we do feel there is an 2 urgent need for a meeting, that we have the support of 3 staff and management, in the event that we so desire.
4 Any other comments or questions?
5 MS. HOLIDAY: Dr. Palestro, if I could 6 just quickly respond, and I'm sorry if I am going to, 7 perhaps, steal your thunder, Chris.
8 But with respect to the timeliness of 9 responding to the actionable items, if you'll notice, 10 a lot of the items we close, we closed several charts 11 in the fall meeting because they were all tied to the 12 rulemaking effort. And as a federal agency, we have 13 to follow our regulatory process in terms of 14 rulemaking efforts. That means that we have to engage 15 members of the public. We have to satisfy all the 16 steps, and there is a flow chart, all of the steps 17 that you have to do for a rulemaking.
18 So for rulemakings, you know we always 19 joke about how it took ten years to push this rule out 20 and ideally, you know we would like things to hit the 21 street within six months. But the reality of it is in 22 order to give a topic, especially one that can be as 23 sensitive and as controversial as medical, that 24 rulemaking got extended and there were several 25 questions. At one point, the ACMUI members NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 participated in specifically a Commission meeting 2 regarding a permanent implant brachytherapy, if I 3 recall. Correct? I see a couple of nods in the 4 audience.
5 So because of things like that, that is 6 why some of the items take us longer to close and it 7 is not because we don't want to take action or that we 8 aren't taking action. Our action may be to -- we are 9 addressing it but we still have to follow that 10 regulatory process.
11 Whereas, other things, actionable items, 12 for example, some subcommittee reports related to 13 licensing guidance. As you guys know, 35.1000 14 licensing is a much more nimble, quicker effort than a 15 rulemaking. As of lately, we have been able to push 16 out 35.1000 licensing guidance within about a year 17 time frame, which is significantly faster than a 18 rulemaking.
19 With regard to rulemaking, there is also 20 another process called a direct final rule, which 21 still has to go through the regulatory process but it 22 is not as -- it doesn't have as many steps as the Part 23 35 rulemaking that we just went through.
24 So if you guys recall, a couple of years 25 ago when Steve Mattmuller was on the committee, he NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 talked about the decommissioning funding plan and how 2 the subcommittee and the committee, ultimately, 3 endorsed the report that said we recommend a direct 4 final rule. And direct final rules are for things 5 where we think that there will be less, or very 6 minimal, or no controversy. But if we get into that 7 process and there ends up being a lot of controversy, 8 then it kicks over to the regular, normal, full blown-9 out rulemaking regulatory process.
10 So it is not to say that NRC staff is not 11 being responsive. It is not saying that we are not 12 taking action. It really depends on what the action 13 is.
14 For example, the information notice that 15 Dr. Tapp referenced yesterday. The staff did take an 16 action. They were evaluating it and, based on their 17 evaluation, it spurred into something else.
18 So I guess my bottom line is to say we are 19 doing something. We are taking action. It depends on 20 what that particular action is.
21 CHAIRMAN PALESTRO: Thank you, Ms.
22 Holiday.
23 Mr. Einberg.
24 MR. EINBERG: Yes, just to add on to what 25 Sophie had to say, I think the frustration from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 ACMUI members may be that they don't understand why it 2 is taking so long. So when we go through the action 3 items that we explain that this is where we are in the 4 process on this particular item so that they have an 5 understanding that it is in rulemaking, rulemaking 6 takes X number of years and this is where we are in 7 the process, so that they don't have that frustration 8 and that they see that these items are being acted 9 upon.
10 Regarding the frequency of meetings, I 11 would also add that another option would be to have 12 three-day meetings, rather than two-day meetings if 13 there are additional topics that need to be discussed.
14 CHAIRMAN PALESTRO: Thank you. Mr. Ouhib.
15 MEMBER OUHIB: Yes, I guess just to answer 16 the concern about you know perhaps things are not 17 being done as expected, which I am not sure I agree 18 with that, is to sort of have some projected target 19 dates, more or less, but they are not set in stone, 20 knowing that sometimes, for whatever reason, there are 21 things that will take longer. But at least having 22 some target date, people will sort of have an idea of 23 what to expect.
24 MR. EINBERG: Yes, excellent idea.
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31 1 questions from the committee?
2 Attendees in the room?
3 Bridge line?
4 All right, I am just going to add one 5 final comment because we are really out of time on 6 this session.
7 And I think it would be helpful for the 8 fall meeting to include a session and explain how the 9 items that the ACMUI itself acts on or recommendations 10 we make, how they go through the pathway to final 11 resolution, like rulemaking and so forth, and give us 12 a sense of the time it takes for each of these things.
13 Because I have been on the committee for eight years 14 and I know that it takes a long time to get many items 15 accomplished but if you were to ask me specifically 16 what path, I don't have that answer, that knowledge 17 and I think it would be helpful to us. It would give 18 us a much better understanding.
19 Any other comments or questions?
20 All right, that concludes this session.
21 Thank you.
22 And now we are ready for the next, which 23 is a special presentation to Ms. Laura Weil, our 24 patients' rights advocate. And Mr. Moore will make 25 this presentation.
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32 1 MR. MOORE: Good morning, ACMUI. Good 2 morning, Chairman. Good morning, Dr. Weil.
3 I am Scott Moore. I am the Deputy 4 Director for the Office of Nuclear Material Safety and 5 Safeguards and today I am here to recognize Dr. Weil 6 with the ACMUI, her contributions to the committee, 7 and to the NRC.
8 This is Dr. Weil's last in-person meeting 9 as the ACMUI Patients' Rights Advocate. Dr. Weil was 10 appointed as the ACMUI Patients Rights' Advocate in 11 2011 and will be completing her second and final term 12 on August 28th, 2019. She serves in a unique and 13 vital role on the ACMUI because the patients' rights 14 advocate serves as a liaison between patients and the 15 healthcare providers on the committee.
16 Patient care is of the utmost concern to 17 the NRC and we are interested in that because 18 byproduct material, obviously, is used to treat and 19 diagnose diseases and cancers.
20 She has briefed the Commission during 21 public Commission meetings on a number of occasions, 22 since she has been with the committee, including in 23 2012 -- actually, every year that she has been on the 24 committee from 2012 until today. In 2012 she talked 25 about medical events, 2013 she talked about patient NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 release, 2014 she talked about radiation safety 2 instruction, 2015 was patients' rights, 2016 was more 3 about patients' rights, 2017 was training and 4 experience, 2018 was a number of different topics, it 5 was three separate topics on T&E recommendations for 6 revisions to patient release and medical event 7 reporting. And then she is again reporting to the 8 Commission today on nursing mothers' guidelines, T&E, 9 and medical event reporting.
10 So she has the honor of having briefed the 11 Commission more than anybody else on the committee, at 12 this point, which may be a dubious honor. So it 13 depends on how you look at it, I guess. If you are a 14 problem licensee, you don't want to be in that place.
15 Anyway, we appreciate your doing that, Dr.
16 Weil, and the Commission appreciates it, too.
17 You have worked with NRC staff to develop 18 a Federal Register notice to request information from 19 the public on patient information and guidance 20 existing on websites and available brochures. And 21 most recently, you provided the staff in our office 22 with comments on the patient release brochure.
23 Since being on the committee, she has 24 attended a number of thyroid cancer survivors' 25 meetings in her role as the patients' rights advocate.
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34 1 And in addition to the things that I just mentioned, 2 we have also benefitted from her experience on a 3 number of high priority issues, including hormesis 4 linear non-threshold, abnormal occurrence reporting, 5 proposed amendments to the ACMUI bylaws, proposed 6 revision to our NRC policy statement on abnormal 7 occurrence reporting, the issue of the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 8 training and experience, the impact of medical event 9 reporting on medical licensee patient safety, patient 10 intervention, and the physical presence requirements 11 for the Leksell Gamma Knife.
12 She also served as the chair of the 2019 13 ACMUI Bylaws Subcommittee.
14 So at this time, we would like to present 15 you with a few tokens of our appreciation. Sophie, I 16 would like to ask you to come up, and Dr. Weil.
17 MEMBER WEIL: I appreciate the promotion 18 but I am not a doctor.
19 MR. MOORE: Oh, I'm sorry, Ms. Weil, yes, 20 actually.
21 So Sophie, if you could hand this to her.
22 Yes, and Kellee, too. Yes.
23 We have a flag that was flown over the 24 Capitol and a certificate from Senator Van Hollen; a 25 certificate of appreciation from Chairman Svinicki; NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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35 1 and finally, a gold lapel pin from the NRC.
2 And so I would just like to tell you from 3 myself, from the staff, and from the NRC as a whole, 4 thank you so much for your service. The Patients' 5 Rights Advocate is a very important role for us, the 6 staff. The committee, as you all know, is filled with 7 medical experts, with government officials, with 8 states' representatives but the patients' rights 9 advocate plays an extremely important role.
10 To us, you know you are representing 11 patients that are out there and we listen very heavily 12 to the comments that you provide. You have been on 13 the committee for a long time and we really, really 14 appreciate your input. So thank you from the staff 15 and from the agency.
16 Would you like to make any comments?
17 MEMBER WEIL: Yes, but I would like to sit 18 down.
19 MR. MOORE: Okay, great. Thanks.
20 MEMBER WEIL: Well thank you very much for 21 reminding me of all the things I've been engaged in 22 because I had forgotten most of that.
23 When I first began my first term on the 24 ACMUI, I was prepared to face a fair amount of 25 suspicion, if not outright hostility in my role as a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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36 1 professional patients' advocate.
2 Someone who calls herself a patients' 3 advocate needs always to be ready for the dangers of 4 usurping that title from others who justifiably see 5 themselves as advocates as well. Almost everyone who 6 works in the healthcare arena has opportunities to 7 advocate for what patients need and often, the front 8 line workers are the unsung heroes in this endeavor.
9 But I was surprised that there was very 10 little, if any, of that reaction here at NRC. And as 11 you will hear me state to the Commissioners, I believe 12 that just about every one of the ACMUI members I have 13 had the privilege to work with over the last nearly 14 eight years has considered patient advocacy an 15 essential core of his or her professional ethic.
16 In my academic career, I used to tell my 17 students that there is patient advocacy with a small p 18 and patient advocacy with a capital P. And that 19 uppercase P represents a more zoomed-out perspective, 20 advocating for groups and populations, rather than the 21 needs of a single small p patient.
22 The uppercase P is certainly the focus of 23 advocacy here at the ACMUI and it needs to be 24 differentiated from what most healthcare workers can 25 accomplish in the course of their often overwhelming NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37 1 primary responsibilities. The uppercase P is what has 2 driven my belief that it is perfectly appropriate for 3 a regulatory agency like NRC to require and not just 4 recommend guidance timely education for patients who 5 are administered radiopharmaceuticals such that they 6 are able to understand, and plan, and effectively 7 protect those around them from unnecessary exposure to 8 radiation. That's a public health issue and it isn't 9 stepping on the toes of the practice of medicine.
10 The uppercase P drives the need to make 11 sure that healthcare providers are competent to use 12 radiopharmaceuticals and have received appropriate 13 training and experience. Indeed, the uppercase P 14 drives much of what the ACMUI tries to accomplish in 15 terms of promoting safety, accessibility, and 16 fairness.
17 That uppercase P also prompted me to 18 repeatedly remind the committee that all of the 19 distinguished professionals in this room work at 20 Centers of Excellence and represent the best of the 21 best in health care. And everyone needs to remember 22 that not all patients experience health care the way 23 it is provided in your facilities. Not all medical 24 personnel have the support that is likely provided in 25 the facilities where you work.
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38 1 Regulation needs to be appropriate for the 2 best facilities but more essentially, it needs to 3 ensure protections for patients and workers in those 4 less-than-best environments, where most health care is 5 delivered in the United States.
6 It has really been a privilege to serve 7 with you and I wish you the very best going forward.
8 MR. MOORE: Congratulations, Ms. Weil. I 9 would like to thank the committee and the chairman for 10 the opportunity to recognize Ms. Weil as well as her 11 briefings to the Commission. And if anybody beats her 12 record of eight presentations to the Commission -- we 13 are keeping track. So, congratulations.
14 MEMBER WEIL: Thanks.
15 MR. MOORE: Mr. Chairman.
16 CHAIRMAN PALESTRO: Laura, you and I have 17 been on the committee for just about the same length 18 of time and I have always come to think of you as the 19 conscience of the committee, reminding us that, as we 20 are going through our various discussions about 21 education and experience, and the various rules and 22 regulations, and so forth, reminding us that 23 ultimately, at the end of the day, it is centered on 24 the best in care and safety for the patient. The 25 patient is of the utmost importance.
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39 1 Now on a personal note, Northwell Health 2 owes you a vote of thanks. A few years ago you had 3 presented the results of a survey that you had done on 4 patients with thyroid cancer. And one of the things 5 that you -- you discussed many things but one of the 6 things that you discussed that stuck in my mind 7 because I am responsible for several institutions, was 8 the variation in instructions that patients got from 9 one institution or one physician to another and how 10 disconcerting that was, not necessarily that the 11 instructions, the variations were wrong or incorrect 12 but there were variations and the patient didn't know 13 what to do.
14 And so I decided that it was time probably 15 to go back and relook at what I had assumed to be 16 consistent instructions from site to site and found 17 that they weren't so consistent and that they did 18 vary. And as the patients moved from one institution 19 to another, they would get one set of instructions or 20 another and that clearly caused them angst.
21 So as a result of your comments and my 22 review of that, it took us a while, but I think that 23 you would be pleased to know, and I know that our 24 patients are, that we finally have it down, for at 25 least our thyroid cancer patients, to a uniform set of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 instructions and guidelines. And for that, we are 2 deeply indebted. Thank you.
3 Anyone else who would like to say 4 anything?
5 Dr. Ennis.
6 MEMBER ENNIS: I just wanted to echo what 7 other people have said, that in the almost four years 8 I have been on the committee, I have always found your 9 comments to be extremely thoughtful, sharpening the 10 debate, the discussion, extremely well expressed, and 11 always a significant contribution to any conversation.
12 So personally, I have enjoyed getting to 13 know you and forming a friendship as well but your 14 professional contributions go beyond the specific 15 presentations that you have made but the role that you 16 have had in regular discussions and all your 17 subcommittees has just been really extremely valuable.
18 CHAIRMAN PALESTRO: Any other comments?
19 Dr. Metter.
20 VICE CHAIRMAN METTER: I haven't been on 21 the committee as long as everybody else. This is, I 22 believe, my third year. And I have always looked 23 forward to your wise comments, your excellent 24 delivery. And you were not afraid.
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41 1 advocate, if a patient were here, I mean they would be 2 very proud of what you stand for for them.
3 And you know there would be discussion and 4 then all of a sudden, Laura's hand would go up and 5 there would be like uh-oh. And the thing is that you 6 would bring a perspective that we are so tunneled in 7 that it would be oh, yes, I forgot about that. And 8 something like what Dr. Palestro said, you know 9 something we take for granted that you bring up and 10 really you are a true patient advocate.
11 And thank you for all the work that you do 12 and really you've opened up the ACMUI to even getting 13 better in what they do. Thank you.
14 CHAIRMAN PALESTRO: Mr. Ouhib.
15 MEMBER OUHIB: Yes, I just want to thank 16 you, Laura, for everything you've brought to the 17 table.
18 It's always good to have a compassionate 19 person that reminds everybody that numbers are good, 20 rules are good, but I think more than everything else, 21 don't forget to be compassionate in everything you do 22 because that is what it will come down to. Thank you.
23 CHAIRMAN PALESTRO: Anyone else?
24 Mr. Einberg.
25 MR. EINBERG: Yes, hi, Laura.
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42 1 So I hired, Laura. I was one of the 2 people who interviewed Laura. And when we went out 3 and were looking for a patients' rights advocate in 4 the position, this is a very difficult position to 5 fill, and we really lucked out with Laura. She has 6 made tremendous contributions to the ACMUI. She has 7 been conscious of the staff here and she has done 8 wonderful.
9 And so we are in the process of looking 10 for a new ACMUI patients' rights advocate and that is 11 going to be a very tough position to fill and very big 12 shoes to fill.
13 So thanks once again. And any advice you 14 have for us regarding what we should look for in a 15 future patients' rights advocate would be appreciated 16 and we can talk offline about that.
17 Thank you.
18 CHAIRMAN PALESTRO: Anyone else?
19 Dr. Howe.
20 DR. HOWE: I've probably seen more ACMUI 21 meetings than anyone else in this room and I have been 22 through -- probably including Scott -- and I've been 23 through a number of different patients rights 24 advocates that we have had on the ACMUI. And I have 25 to tell you Laura has set the bar extremely high. She NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 has been one of the best patient advocates we have 2 had.
3 And I hope in the future we are able to 4 make a decision that brings a new patient advocate in 5 that will meet her high standards because it has been 6 very important to the ACMUI to have that different 7 perspective and she has contributed a tremendous 8 amount to the NRC and the ACMUI.
9 Thank you, Laura.
10 CHAIRMAN PALESTRO: Dr. Dilsizian.
11 MEMBER DILSIZIAN: Well, Laura, when I 12 joined the ACMUI, I had no expectation of what the 13 patient advocate was going to be promoting, except my 14 experience with the IRBs. I had a lot of patient 15 advocates in the IRB meetings. You know usually their 16 comments are directed to the patient consent form, 17 understanding of the wordings, et cetera.
18 But I have learned so much from you. I 19 have served in so many committees with you. Not only 20 do you provide insight, you also are -- you edit a lot 21 of our reports very accurately and correctly. And I 22 have to say that you have also taught me that our 23 perspective here is really, as you said, from 24 university hospitals, where we tend to forget. And 25 several times you pointed out to me, I said this is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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44 1 how we do it at Maryland and you said but that's not 2 normal. And then that was kind of unusual for me to 3 hear that and I think I learned a lot from you. And 4 yes, I have a different perspective.
5 And I also respect that you are willing to 6 change your mind. A lot of times, you start with a 7 certain opinion. After discussions, you kind of 8 change. And that is big.
9 Thank you very much.
10 CHAIRMAN PALESTRO: Anyone else?
11 MS. HOLIDAY: Does anybody before I go?
12 Okay. So unlike Donna-Beth, I have not 13 been around for as many ACMUI meetings but I have been 14 around for all of Ms. Weil's ACMUI meetings. And 15 after hearing what everybody has said, you know it is 16 absolutely true.
17 And one of the remarkable things about Ms.
18 Weil is that she is so humble. You were humble every 19 time you were placed on a subcommittee. And she is 20 the first person to say, you know I am not the subject 21 matter expert and I don't have any technical expertise 22 but then you come in and you add so much value to the 23 discussions, to the report. You have wordsmithed the 24 heck out of everything, out of our patient release 25 brochure. The staff has reached out to Ms. Weil on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 numerous occasions as it relates to patient release.
2 And we are very, very fortunate to have 3 had you here on the committee. We have been around 4 for the birth of children, for the birth of 5 grandchildren. We are the fellow vertically-6 challenged people and I am happy to be able to call 7 you a friend.
8 So congratulations and thank you.
9 CHAIRMAN PALESTRO: Anyone else?
10 All right, Laura, I think what we've heard 11 sums up everything about you and, again, on behalf of 12 myself and the committee, everyone here, our sincere 13 thanks for your eight years of service and we hope we 14 don't lose touch.
15 Thank you very much.
16 All right, that concludes this session.
17 We are on a break now until ten o'clock. The 18 Commission meeting is in White Flint One. All right, 19 very good. We will see you there. Thank you.
20 (Whereupon, the above-entitled matter went 21 off the record at 9:25 a.m. and resumed at 1:15 p.m.)
22 CHAIRMAN PALESTRO: All right, welcome 23 back. We will call this afternoon's final session to 24 order.
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46 1 the program, I just want to thank Doctors Metter, 2 Ennis, and Ms. Weil for their contributions and 3 presentations at this morning's session with the 4 Commission. It certainly -- obviously, I am 5 prejudiced because I was part of it, but I think it 6 was the best of all the sessions that I have been 7 involved with the commissioners. I thought it was an 8 excellent dialogue and I received compliments from 9 many people. And I really appreciate that and it 10 really goes to all of you folks.
11 And in fact some woman, who I have no idea 12 who she was, stopped me on the street and said good 13 meeting, Palestro. So, whoever it was, I think we did 14 a good job.
15 (Laughter.)
16 CHAIRMAN PALESTRO: That may be a custom 17 here in Rockville and Bethesda.
18 So thank you all very much. I appreciate 19 that job well done.
20 All right. So we are going to move on to 21 the next topic, the ACMUI Bylaws Subcommittee Report 22 and Ms. Weil will present this.
23 MR. WILLIAMS: Dr. Palestro, if I could, I 24 want to correct the record.
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47 1 presentation, I wanted to -- before the break and Mike 2 Fuller and I had this conversation during the 3 Commission meeting, I wanted to just correct one thing 4 on the record.
5 We were talking about the advantages or 6 disadvantages of ACMUI reporting either to the 7 Commission or staying at the same place with reporting 8 to the Division Director. And one of the comments 9 that was made is that the -- and I am paraphrasing but 10 that the staff had nothing to offer.
11 And what I wanted to correct was the staff 12 has a vast amount of knowledge and expertise in terms 13 of health physics and things of that nature. What is 14 being supplemented is the vast expertise that the 15 ACMUI Committee brings in a variety of areas that we -
16 - you know so we have identified the gap. And 17 together, I think we work very well and complement 18 each other, and we are able to provide and address a 19 number of activities.
20 So, thank you.
21 CHAIRMAN PALESTRO: Thank you, Mr.
22 Williams.
23 All right, now we are going to proceed to 24 the Bylaws Subcommittee report with Ms. Weil.
25 MEMBER WEIL: Thank you. Can I have the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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48 1 next slide? Do I have control of the slides? Thank 2 you.
3 So I would like to thank my fellow 4 subcommittee members, Robert Schleipman, Michael 5 Sheets, Megan Shober, and our staff resource was 6 Sophie Holiday.
7 The subcommittee charge was to review the 8 ACMUI Bylaws and recommend updates, with particular 9 focus on the question of whether the ACMUI chair may 10 serve as a member or a chair of any subcommittee.
11 So we considered two issues. Should the 12 ACMUI chair be allowed to participate in the 13 subcommittees and, if so, in what capacity? And what 14 language, if any, should be added to the bylaws to 15 clarify this question?
16 And we also considered whether there were 17 any other clarifications or additions to the ACMUI 18 bylaws that should be considered.
19 Regarding the ACMUI chair participation on 20 subcommittees, it has been the practice of the NRC to 21 prohibit the participation of the ACMUI chair in 22 subcommittee deliberations and recommendations. This 23 was recently brought to the attention of the incoming 24 ACMUI chairman, Dr. Palestro, who was asked to 25 relinquish his position as chair of an ongoing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 subcommittee in anticipation of his role as ACMUI 2 chairman.
3 Dr. Palestro felt that this issue should 4 be investigated by a subcommittee and an explicit 5 recommendation be made to the ACMUI with potential 6 clarification in the ACMUI bylaws. The current ACMUI 7 chair and vice-chair would not vote on the 8 recommendation put forth by this subcommittee.
9 ACMUI bylaws do not address this point, 10 nor does the ACMUI charter. The documents of our 11 sister NRC Federal Advisory Committee, the Advisory 12 Committee on Reactor Safeguards, is also generally 13 silent on the issue, although the ACRS chair is the 14 designated chair of a standing subcommittee. We don't 15 have standing subcommittees.
16 There is no discussion of this issue on 17 the FACA website, nor did consult with FACA staff 18 suggest any required position on the issue.
19 Several other FACA committee bylaws and 20 charters were reviewed by the subcommittee and none 21 had explicit language regarding the potential for 22 chair membership and participation in subcommittee 23 work.
24 The understood rationale for the existing 25 informal prohibition is that the role of the chair is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 onerous and time-consuming and it would be an 2 imposition to expect the chair to undertake additional 3 -- is this slide 4? Do we have slide 4? It doesn't 4 matter. We can go forward -- to undertake any 5 additional responsibilities.
6 And the second rationale is that the chair 7 might, exert undue influence on subcommittee 8 deliberations.
9 Can you go forward to slide 4? Okay.
10 Section 1.3.6 of the ACMUI Bylaws 11 explicitly states the chair may take part in the 12 discussion of any subject before the ACMUI and may 13 vote. The chair should not use the power of the chair 14 to bias the discussion. And any dispute over the 15 chair's level of advocacy shall be resolved by a vote 16 on the chair's continued participation in the 17 discussion of the subject.
18 Each member of the ACMUI has a specific 19 area of expertise and in some cases, there is no 20 duplication of expertise among all members. The 21 subcommittee felt that any subcommittee should be able 22 to avail itself of the relevant expertise of any 23 member of the ACMUI. The potential for benefit of any 24 given subcommittee outweighs the potential for undue 25 influence by the position of the chair.
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51 1 So here is an example. Recent 2 subcommittee relating to gamma stereotactic 3 radiosurgery licensing guidance, only one member of 4 the ACMUI had specific and significant GSR experience.
5 Had that member been the ACMUI chair and prohibited 6 from subcommittee participation, the subcommittee 7 would have been deprived of essential information and 8 input in its deliberations.
9 Concern was expressed that the ACMUI 10 chair's participation on a subcommittee should not 11 overburden or compromise the ability of the chair to 12 perform the duties of ACMUI chair. So it is proposed 13 that the ACMUI chair not be asked to serve as a 14 subcommittee chair.
15 The subcommittee also discussed whether 16 explicit bylaws language is required to address the 17 question or whether a formal position expressed and 18 captured in the ACMUI meeting would be adequate. The 19 membership of the ACMUI turns over completely every 20 eight years or sooner and NRC staff rotate in and out 21 of the medical team with unpredictable frequency. It 22 is challenging to research areas of tradition and 23 practice such as this. The minutes and transcripts of 24 ACMUI meetings, while available, aren't indexed by 25 subject.
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52 1 It was felt that there are potential 2 limits to ACMUI institutional memory such that 3 inclusion of specific language in the bylaws would be 4 beneficial and the most efficient way to address this 5 issue.
6 New language is suggested to be inserted 7 in the existing bylaws regarding ACMUI chair 8 discussion, participation, and voting rights. So this 9 would go into 1.3.6 and we suggest amending the 10 statement with in matters where the ACMUI chair's 11 unique experience and knowledge would be especially 12 informative, the chair may serve on relevant 13 subcommittees. In these instances, the ACMUI chair 14 will not chair the subcommittee.
15 With respect to additional bylaws 16 additions, the subcommittee felt that the existing 17 language in the bylaws regarding conflict of interest 18 was vague.
19 The bylaws currently state, under Section 20 4, Conduct of Members, if a member believes that he or 21 she may have a conflict of interest with regard to an 22 agenda item to be addressed by the ACMUI, this member 23 should divulge it to the chair and the DFO as soon as 24 possible and before the ACMUI discusses it as an 25 agenda item. ACMUI members must recuse themselves NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 from discussion of any agenda item in which they have 2 a conflict of interest.
3 The subcommittee suggests that the bylaws 4 be amended with additional language to identify more 5 clearly what constitutes a conflict of interest.
6 The following language -- can you go to 7 the next slide -- is used in the ACRS bylaws, Section 8 10.2-2, defining what constitutes a financial conflict 9 of interest and we think it should be inserted or 10 considered for amending the ACMUI bylaws.
11 And this is what is in the ACRS bylaws and 12 it is pretty simple. It just identifies that a 13 financial conflict would directly or predictably 14 affect the personal financial interest of a spouse, 15 minor child, the organization in which they serve as 16 an officer, director, trustee, general partner, or 17 employee, an organization in which they are 18 negotiating or have an arrangement for prospective 19 employment.
20 However, the subcommittee welcomes staff 21 input on other language that would still provide 22 adequate clarification if this is not thought to be 23 useful.
24 So, in summary -- next slide -- we 25 recommend that the ACMUI chair should be permitted to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 serve as a subcommittee member, not chair, when his or 2 her specific expertise is necessary and a specific 3 statement to that effect should be included in the 4 ACMUI bylaws.
5 And the subcommittee recommends that more 6 explicit language be included in the bylaws defining 7 conflict of interest with respect to participation of 8 individual ACMUI members in discussion of matters that 9 come before the committee.
10 Thank you.
11 CHAIRMAN PALESTRO: Any comments from 12 other members of the subcommittee?
13 MEMBER SCHLEIPMAN: I have one comment.
14 The second slide erroneously refers to me as M.D. I 15 guess I got promoted like you earlier today. So just 16 for the record that that could be removed.
17 CHAIRMAN PALESTRO: Any other comments or 18 questions from the subcommittee? From the committee?
19 Mr. Ouhib.
20 MEMBER OUHIB: Yes, can we go back to 21 slide number 8, please? I'm not sure if I am in favor 22 of that statement members cannot participate in the 23 review of any particular matter.
24 I think as long as the conflict of 25 interest is disclosed, okay, to the chair, basically, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 1 or to the subcommittee, or whatever, I don't see why 2 that member should not participate without voting, per 3 se. Because that person might very well have valuable 4 information to the committee but then they will up-5 front disclose as the conflict comes because six 6 months from now there was no conflict but all of a 7 sudden now, there is a conflict.
8 They can simply disclose it at the very 9 beginning but then they should be able to participate 10 but perhaps they should not be voting.
11 CHAIRMAN PALESTRO: This issue actually 12 came up, I believe, at the last meeting and there was 13 in fact a conflict of interest or a potential conflict 14 of interest and it was decided that individual could 15 not participate on the subcommittee.
16 And in fact a decision, and correct me if 17 I am wrong, Ms. Holiday, but that decision really went 18 beyond the ACMUI's choice. That went I guess through 19 legal. Is that right?
20 MS. HOLIDAY: That is correct. And just 21 for clarification, in the existing ACMUI bylaws 22 Section 4.1, the language specifically states if a 23 member believes that he or she may have a conflict of 24 interest with regard to an agenda item to be addressed 25 by the ACMUI, this member should divulge it to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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56 1 chair and the DFO as soon as possible and before the 2 ACMUI discusses it as an agenda item. ACMUI members 3 must recuse themselves from discussion of any agenda 4 item in which they have a conflict of interest.
5 This is also covered in your annual ethics 6 training. As it so happens, we have some 7 representatives from the Office of General Counsel 8 here.
9 MS. HOUSEMAN: Hi, Esther Houseman --
10 MS. HOLIDAY: Esther, you have to push the 11 button. There is a gray button.
12 MS. HOUSEMAN: Esther Houseman, Office of 13 the General Counsel.
14 I just want to quickly point out that it 15 looks to me like this provision from the ACRS bylaws 16 is a restatement of the Office of Government Ethics 17 rule on financial conflict of interest. So these are 18 actually Office of Government Ethics requirements and 19 nothing in the ACMUI's or the ACRS's charter, or 20 bylaws, or NRC regulations can change that.
21 And so if you are to revise the conflict 22 of interest provisions in the ACMUI bylaws, in 23 addition to the staff, the NMSS staff, the Office of 24 the General Counsel can review those and provide input 25 to ensure that they align with the Office of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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57 1 Government Ethics rules.
2 MS. HOLIDAY: Thank you.
3 And just to follow-up to what Ms. Houseman 4 just said, Section 5.4 of the bylaws says the ACMUI 5 shall consult with the Office of General Counsel 6 regarding conflicts that arise from the interpretation 7 of the bylaws. After consultation, the ACMUI shall 8 resolve interpretation issues by a majority vote of 9 the current membership of the ACMUI.
10 So basically, the process -- I don't see 11 many members here from back when we passed the bylaws 12 in 2014, except for maybe the latter part of this 13 table. The ACMUI had made recommendations to change 14 the bylaws in 2014. So after we revised those bylaws 15 in a public meeting, so that everybody could see the 16 language that was proposed and agreed to, it had to go 17 through our Office of General Counsel for them to give 18 us what they call a no legal objection, meaning that 19 there is nothing legally objectionable to it. And 20 that from there, it could be finalized.
21 So as Ms. Houseman stated, this language 22 is directly from OGE, the Office of Government Ethics.
23 It is a more detailed explanation than what is 24 currently in our bylaws. So all Ms. Weil's 25 subcommittee was doing was wanting to update the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 language that I had initially read to correspond to 2 the language that is verbatim from OGE and, 3 coincidentally, captured in the ACRS bylaws.
4 CHAIRMAN PALESTRO: Thank you, Ms.
5 Holiday.
6 Dr. Dilsizian.
7 MEMBER DILSIZIAN: Yes, I completely 8 agree. I think that even if -- if you have a conflict 9 and you are in the discussion, period, you can 10 convince other people's minds. So that is the reason 11 I think it should be completely -- and you know any 12 organization, any meeting, any Board of Directors, if 13 you remember, you always recuse yourself. You never 14 really try to convince the others.
15 Even though your expertise may be unique, 16 I think that this is the proper way, in my opinion.
17 Now regarding your presentation, Laura, I 18 think could you go back to maybe six, slide 6?
19 Okay, so I agree with you that the concept 20 that if the chair has unique experience, obviously, he 21 should serve as a member. You say in these 22 circumstances, the ACMUI chair will not chair the 23 subcommittee.
24 In my opinion, it is not only in these 25 instances. In any other instances, the chair should NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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59 1 not chair a subcommittee. You know what I am saying?
2 It just seems like others --
3 MS. HOLIDAY: So is there a motion on the 4 table to amend the recommendation?
5 CHAIRMAN PALESTRO: I am not done.
6 MS. HOLIDAY: Sure.
7 CHAIRMAN PALESTRO: Ms. Weil, you are 8 reporting the case that the ACMUI chair, under certain 9 circumstances, can serve on a subcommittee. The 10 question is, who makes the determination, the 11 subcommittee chair or the ACMUI chair?
12 MEMBER WEIL: So the ACMUI chair would be 13 establishing the subcommittee, correct? You establish 14 our subcommittees.
15 CHAIRMAN PALESTRO: That's correct.
16 MEMBER WEIL: And so I would think that it 17 would be the chair of the subcommittee. You choose a 18 subcommittee. The chairman of the ACMUI --
19 CHAIRMAN PALESTRO: That's correct, yes.
20 MEMBER WEIL: -- chooses the subcommittee, 21 designates a chair of that subcommittee, and that 22 chair then would be the person to request the 23 participation of the appropriate specialist, who 24 happens to be the ACMUI chair.
25 CHAIRMAN PALESTRO: Thank you.
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60 1 Mr. Sheetz.
2 MEMBER SHEETZ: I just want to comment on 3 that. I would think that the chair would be able to 4 appoint him or herself to the subcommittee and, if the 5 chair did not appoint him or herself to subcommittee, 6 the subcommittee chair could ask the chair to serve on 7 that committee, should they feel that that expertise 8 was necessary.
9 That covers all ends.
10 CHAIRMAN PALESTRO: Dr. Ennis.
11 MEMBER ENNIS: So the point of these kinds 12 of rules are to avoid abuse of power. It feels a 13 little like okay, that's not going on. Now we're all 14 getting along and all of that. But the point of this 15 is well what happens if there is an issue, which has 16 happened in the past, from what we understand. Most 17 of us weren't here then.
18 So I feel a little uncomfortable about the 19 notion that the chair appoints his friend, who then 20 will turn around and appoint his friend back on the 21 committee. That feels too cozy and allows for a 22 little bit of abuse of power over what kind of 23 relationship those two might have in all kinds of 24 ways.
25 So I would prefer that this exception in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 allowing the chair to be on a subcommittee be 2 something that either the entire ACMUI has to vote on 3 or the subcommittee in its entirety has to vote on.
4 MS. HOLIDAY: Dr. Ennis, thank you for 5 raising that point. So I will also read for you 6 Section 1.3.6 of the bylaws. And it states the chair 7 may take part in the discussion of any subject before 8 the ACMUI and may vote. The chair should not use the 9 power of the chair to bias the discussion. Any 10 dispute over the chair's level of advocacy shall be 11 resolved by a vote on the chair's continued 12 participation in the discussion of the subject.
13 So one could say that you could either 14 reference Section 1.3.6, if that is the recommendation 15 of the committee, you can model it after the language 16 in Section 1.3.6. But I do want to make you aware of 17 the language that is currently in the bylaws.
18 MEMBER WEIL: What we are suggesting is 19 that this statement follow and be included in 1.3.6 20 but be included in that paragraph.
21 CHAIRMAN PALESTRO: Any other comments or 22 discussion?
23 Comments/questions from attendees in the 24 room? Bridge line?
25 Dr. Howe.
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62 1 DR. HOWE: I just had a question. When 2 you are proposing to change the conflict of interest, 3 it seems to be only addressing financial reasons.
4 In some cases in the past, we have had --
5 and I don't think this would be necessarily financial, 6 but we have had cases where maybe a member of the 7 ACMUI has a licensing action in front of the NRC and 8 that might be a conflict of interest for that person 9 to be actively representing a certain position on that 10 type of licensing action.
11 So I think the conflict of interest is a 12 little broader than just financial. I think you 13 should consider.
14 CHAIRMAN PALESTRO: Ms. Weil, any comments 15 on that?
16 MEMBER WEIL: Yes, I looked at other 17 conflict of interest statements in other advisory 18 committee bylaws and they can run to several pages.
19 And I guess I would rely on our counsel to suggest 20 whether or not our bylaws need additional language, or 21 whether the statement -- well, not counsel -- on us to 22 decide whether we need additional language or whether 23 or not we just can rely on that statement where we 24 refer back.
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63 1 clarification because conflicts do come up in this 2 committee. They do come up and we had one recently.
3 And I think we could all use a bit of guidance.
4 I guess I would love to open this to 5 subcommittee members about whether you think we need 6 the broad description of conflict.
7 MEMBER SCHLEIPMAN: So this is Robert.
8 I agree with Dr. Howe that there can be 9 other conflicts. And the existing language in 4.1 10 permits all of the -- you know more than financial 11 conflicts to be addressed or reviewed.
12 I think what you are asking, perhaps, or 13 suggesting is that all of the committee members have a 14 clear understanding of what types of situations may 15 constitute a conflict. Most people know but perhaps 16 we are not regularly familiar with the Code of Ethics, 17 although we have reviewed it and so forth.
18 And so if there is just a reference to 19 what are the descriptions for a conflict of interest, 20 that may be fine, rather than substituting the broader 21 language, which permits consideration of all types of 22 conflicts.
23 CHAIRMAN PALESTRO: Mr. Green.
24 MEMBER GREEN: In light of the comment to 25 be not quite so specific, to focus purely on financial NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 interest, if we go to slide 8 in the proposed 2 language, as proposed by the subcommittee, if we 3 struck the word financial out of the fourth row, to 4 predictably affect their personal interest or the 5 financial -- or again, I guess we would strike 6 financial twice out of that first paragraph. If we 7 struck that word out twice, then it is not solely 8 focused on financial matters but also include 9 licensing activities of all of these items below.
10 MEMBER WEIL: I believe we just heard that 11 we can't alter the language, that we need to use the 12 language that already exists.
13 MS. HOUSEMAN: OGC would review whatever 14 proposal you put forth and could assist in drafting 15 language, again, that aligns with the government 16 ethics rules. And it all depends on just to what 17 extent do you want to summarize and incorporate the 18 government ethics rules into your bylaws to serve as 19 just an additional place where you can look to think 20 about is there a conflict of interest here.
21 I don't think that striking the term 22 financial would work, again, because I think that this 23 restatement captures specifically the financial 24 conflict of interest government ethics rule.
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65 1 document that we can refer to in the bylaws that --
2 rather than restating it, can we just reference it as, 3 Dr. Schleipman asked?
4 MS. HOUSEMAN: We could find the 5 regulatory references so to the particular government 6 ethics rules, if that is what you are asking.
7 MEMBER WEIL: That might be the most 8 efficient way to approach this.
9 MS. HOUSEMAN: It might be, yes.
10 MEMBER WEIL: Efficient is good.
11 CHAIRMAN PALESTRO: Mr. Ouhib.
12 MEMBER OUHIB: Yes, just I would make a 13 suggestion. Perhaps for every subcommittee at the 14 beginning of each session to sort of remind people 15 about the conflict of interest to state that. And 16 that is very common in several medical organizations 17 when there is a task group or whatnot to actually at 18 the very beginning state that if you have any conflict 19 of interest to state it now and remove yourself.
20 Because you just never know. It is sort of like 21 reminding people about that policy.
22 CHAIRMAN PALESTRO: Mr. Ouhib, just so 23 that it is clear in my mind what you said, that you 24 would like to have a conflict of interest reviewed at 25 the beginning of every meeting and every telephone NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1 conference?
2 MEMBER OUHIB: Not necessarily review it 3 but state it sort of as a reminder to people that if 4 you have a conflict of interest, that you need to 5 remove yourself from any discussion that is going to 6 take place.
7 CHAIRMAN PALESTRO: I think that that is 8 an excellent point.
9 Mr. Einberg.
10 MR. EINBERG: Maybe we could add that to 11 the opening remarks.
12 CHAIRMAN PALESTRO: Thank you.
13 Any other comments or questions?
14 All right. In terms of the subcommittee's 15 report, it has actually got two separate components 16 and I would ask Ms. Weil and the subcommittee what do 17 you think about deferring a vote on the conflict of 18 interest until such time as legal provides us with a 19 more comprehensive or more appropriate, if you will, 20 definition?
21 MEMBER WEIL: I would suggest that the 22 report should be amended to remove the in these 23 instances statement. So the chair may serve on 24 relevant subcommittees. The ACMUI chair will not 25 chair the subcommittee. So that recommendation is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 amended to remove those three words: in these 2 instances.
3 CHAIRMAN PALESTRO: And you add that the 4 ACMUI chair will serve on a subcommittee at the 5 subcommittee's discretion.
6 MEMBER WEIL: Yes.
7 Okay and regarding the conflict of 8 interest, I would suggest that the report be amended 9 to state the same things, the subcommittee felt that 10 the existing language in the bylaws regarding conflict 11 of interest was vague. And then there is the citation 12 of Section 4, Conduct of Members, which describes what 13 -- yes, there it is.
14 And then instead of amending the bylaws 15 with language, I would just suggest that we refer in 16 Section 4.1 to the government document that we will be 17 able to cite, once we have that citation, and take out 18 all the other language about financial conflict.
19 CHAIRMAN PALESTRO: Regarding a conflict 20 of interest, is that acceptable to legal? Ms. Weil's 21 proposal, does that make sense?
22 MS. HOUSEMAN: It does but to confirm, I 23 would need to go back to the division in the Office of 24 the General Counsel that specializes in advising on 25 the government ethics rules and run it by them.
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68 1 CHAIRMAN PALESTRO: Thank you.
2 Any more, comments, questions, discussion 3 on these two topics?
4 All right, can I have a motion to approve 5 the amended report? Dr. Dilsizian.
6 Second?
7 (No audible response.)
8 CHAIRMAN PALESTRO: Any further 9 discussion?
10 All in favor?
11 Any opposed?
12 Any abstentions?
13 Okay and Ms. Holiday, I would like to go 14 on the record as indicating that my abstention was not 15 or should not be considered a vote against or a 16 negative vote but rather, as I stated when I formed 17 the subcommittee, abstention because of the obvious 18 conflict of interest.
19 I would like to thank the subcommittee for 20 your work on this because I found this a very vexing 21 issue, as the chair, having been so intimately 22 involved in the Training and Experience Subcommittee 23 and then being told that I had to give it up and not 24 being able to find a hard and fast reason as to why 25 documented. It was difficult.
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69 1 So I think you have cleared, at least for 2 me and hopefully, for future chairs what potentially 3 can become an issue and I thank you very much for 4 that. And I think your rationale for doing so 5 regarding expertise was exactly something that had 6 come up in my mind when Dr. Metter and I had talked 7 about it.
8 In your report, you alluded to another 9 issue, another problem that we sometimes face and that 10 is institutional memory, going back and trying to 11 retrieve documents and so forth in the past. There is 12 no good way to do it and we ran into that numerous 13 times continually, when we tried to sort through how 14 the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> for training and experience was arrived 15 at.
16 Having said that, I think it is reasonable 17 to form a subcommittee with a charge for improving or 18 at least attempting to improve the ACMUI's 19 institutional memory.
20 MEMBER WEIL: I believe that the website 21 that has been established for ACMUI subcommittee 22 charges and reports will ameliorate that situation 23 going forward. Do you think Sophie?
24 CHAIRMAN PALESTRO: The answer is I don't 25 know but one of the issues that comes up is, and you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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70 1 noted in your report, that while there are transcripts 2 of the meeting minutes, they aren't categorized or 3 there is no cross-referencing by subject.
4 So while I think the website improves 5 things, I'm not sure that it solves all of the issues.
6 And the truth of the matter is, the subcommittee can 7 come back and say this is as good as it gets; there 8 are no additional recommendations. I think it 9 behooves us to look at it.
10 That's my only thought. And maybe this is 11 where it ends.
12 So with that in mind, I am going to ask 13 Dr. Schleipman to chair this committee. I am going to 14 ask Ms. Shober to be a part of that; Ms. Weil, for 15 whatever time you have left, I would like to have you 16 on that; Dr. Ennis; and Dr. O'Hara because you work 17 for another federal agency and you may have some 18 unique insights into institutional memory.
19 All right, staff resource? Okay, Ms.
20 Kellee Jamerson.
21 All right and then finally, before we move 22 on to the open forum, if I could just ask the 23 subcommittee chairs, when you are presenting your 24 reports, be they slides or full reports, please make 25 sure to include the name of the staff resource on that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 introductory slide.
2 All right, the next item on the agenda is 3 the open forum; topics of interest previously 4 identified or maybe not identified. Anybody have 5 anything that they would like to bring up?
6 Ms. Dimmick.
7 MS. DIMMICK: Thank you. Lisa Dimmick, 8 Medical Team Leader.
9 It is more or less just a follow-up to a 10 previously discussed item and it is about the Medical 11 Event Subcommittee's recommendation for an information 12 notice. It was discussed during the Commission 13 briefing and there wasn't really an opportunity for 14 staff to provide any input to that. But I did want to 15 add that that information notice is on the Medical 16 Team's work plan for FY19. So we do plan to have at 17 least the IN drafted and hopefully starting in 18 concurrence by the end of fiscal year '19. So that 19 would be the end of September.
20 So in anticipation that there should be an 21 information notice drafted in September.
22 CHAIRMAN PALESTRO: Thank you.
23 Dr. O'Hara, a little while ago, you and I 24 were talking and I suggested that you bring up your 25 observations at the open forum. And so could I ask NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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72 1 you to expand on it?
2 MEMBER O'HARA: Yes, yesterday we were 3 discussing the National Nuclear Safety Association's 4 plans for isotope use in the United States. And I sit 5 on a couple of their committees. So I have some 6 knowledge of what is going on. There is someone at 7 NRC who sits on that committee as well, because I have 8 heard her speak before.
9 But what I heard was concern from Ms.
10 Martin and others that we will lose the use of 11 specific isotopes. And we all know that the isotope 12 that is tops on the hit list is cesium but people were 13 mentioning other isotopes. So what I suggested to Dr.
14 Palestro was that we invite the NNSA here to tell us 15 about their -- where they are, where they are going 16 and so that we have the option to understand where 17 they are going and begin to push back, if they are 18 planning on getting rid of iridium or something like 19 that.
20 CHAIRMAN PALESTRO: Ms. Holiday, before I 21 open the discussion to the group, are there 22 restrictions on having invited speakers?
23 MS. HOLIDAY: No, absolutely not. If you 24 guys will remember, a couple of years ago when NNSA 25 was rolling out their GTRI program -- am I saying that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 right -- G-T-R-I program, NNSA came and gave 2 presentations on that. So they are not -- they are a 3 familiar face here.
4 So if this is something that the committee 5 wishes to hear about, then we will make the contact 6 with NNSA.
7 CHAIRMAN PALESTRO: Comments, questions?
8 MR. EINBERG: Yes, if Dr. O'Hara has a 9 contact person, that would help facilitate us making 10 that arrangement.
11 CHAIRMAN PALESTRO: Any other comments or 12 questions?
13 Ms. Martin.
14 MEMBER MARTIN: I would just speak in 15 support of that. I think it would be wonderful for 16 this committee to know what the plans are as far as 17 use of medical isotopes. Are the restrictions 18 potential restrictions on the use of certain isotopes?
19 CHAIRMAN PALESTRO: Dr. Ennis.
20 MEMBER ENNIS: Yes, I would encourage us 21 to embrace this topic. I have a lot of concerns about 22 and have heard about grumblings before. I kind of 23 alluded to it in the Commission briefing. And 24 whatever we can do to kind of engage them in dialogue, 25 perhaps even suggesting they have their own ACMUI NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 might be good.
2 So, let's start the conversation.
3 CHAIRMAN PALESTRO: Any other comments or 4 questions? Attendees in the room? Bridge line?
5 All right, Dr. O'Hara, can I ask you to 6 put this in the form of a motion?
7 MEMBER O'HARA: I move that the ACMUI 8 contact the NNSA and ask them to come to a meeting, to 9 one of our meetings and review their plans for isotope 10 utilization in the United States.
11 CHAIRMAN PALESTRO: Second?
12 Dr. Schleipman.
13 Any further discussion?
14 All in favor?
15 Any opposed?
16 All right, thank you very much for that, 17 Dr. O'Hara.
18 And I think, recognizing that there are a 19 lot of things that need to be accomplished at these 20 meetings and so forth, that going forward we need to 21 consider having outside individuals from different 22 groups appear more often. It strikes me that over the 23 course of my eight years, most of the time the outside 24 speakers have been vendors.
25 MS. HOLIDAY: Dr. Palestro and Dr. O'Hara, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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75 1 if I may, I know that the committee just voted 2 unanimously for this recommendation.
3 Point of clarification: I think the 4 committee means the NRC staff will reach out, not the 5 ACMUI will reach out.
6 CHAIRMAN PALESTRO: Thank you.
7 MS. HOLIDAY: Thank you.
8 CHAIRMAN PALESTRO: Any other items for 9 the open forum?
10 All right, hearing none, we will move on 11 to the administrative closing and I will turn this 12 over to Ms. Jamerson.
13 MS. JAMERSON: So I provided a meeting 14 Doodle poll to all of the members of the committee for 15 tentative dates for the 2019 fall ACMUI meeting.
16 Again, our fall meeting occurs in either 17 September or October and, as it's been mentioned, Dr.
18 Palestro's term ends September 21st. So I wanted to 19 schedule the meeting prior to the end of his term.
20 Considering this, the selection of dates 21 for the fall meeting was rather limited. And so the 22 options that received the most votes were for 23 September 9th and 10th; September 10th and 11th; and 24 September 11th and 12th.
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76 1 is there a preference of the committee for the fall 2 meeting?
3 MEMBER MARTIN: I just realized I can't 4 make any of those dates. I'm going to be out of the 5 country. I'm sorry.
6 MS. JAMERSON: So I will clarify that for 7 September 9th, Mr. Green and Ms. Martin have 8 conflicts. For September 10th, again, Mr. Green and 9 Ms. Martin have conflicts. For September 11th, Ms.
10 Martin is also away. And for September 12th, Dr.
11 Dilsizian and Ms. Martin have conflicts.
12 MEMBER DILSIZIAN: I could potentially 13 make the 12th.
14 MS. JAMERSON: Okay.
15 MEMBER GREEN: I could potentially make 16 the 10th. I'd just have to do some travel 17 arrangements.
18 MS. JAMERSON: So I propose from this that 19 September 11th and 12th as the first option and, for 20 the backup dates, would be September 10th and 11th.
21 Is that okay with the committee?
22 CHAIRMAN PALESTRO: Works for me.
23 Other members? Ms. Martin.
24 MEMBER MARTIN: Point of clarification.
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77 1 report back at this meeting, do you want me to try and 2 get the report meeting and have some other member of 3 the committee give it or hold the subcommittee report 4 until the spring meeting?
5 CHAIRMAN PALESTRO: There are a couple of 6 ways it could be done. One, is to prepare the report 7 and have someone designated from your subcommittee.
8 That might be the easiest.
9 MEMBER MARTIN: Okay.
10 CHAIRMAN PALESTRO: Alternatively, we 11 could hold a telephone conference meeting over the 12 summer.
13 MEMBER MARTIN: Okay.
14 CHAIRMAN PALESTRO: All right. I would 15 rather not delay it beyond the fall meeting.
16 MS. JAMERSON: Okay.
17 CHAIRMAN PALESTRO: I'm sorry, Ms.
18 Jamerson, for me could you repeat the days?
19 MS. JAMERSON: Yes, so our fall meeting 20 will be September 11th and 12th and our backup date 21 will be September 10th and 11th.
22 CHAIRMAN PALESTRO: Thank you.
23 MS. JAMERSON: So the other portion of our 24 administrative closing is where we review any of the 25 new recommendations or actions that have occurred NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 during the course of this two-day meeting.
2 First, the ACMUI endorsed the Yttrium-90 3 Microsphere Brachytherapy Licensing Guidance, Revision 4 10 Subcommittee report and the recommendations therein 5 with the caveat that the term drug be changed to 6 device. Do you agree?
7 CHAIRMAN PALESTRO: Yes.
8 MS. JAMERSON: Okay. Secondly, Dr.
9 Palestro formed a Subcommittee to Reevaluate the 1980 10 Infiltration Decision and report to the committee at 11 the fall 2019 meeting with any recommendations. The 12 subcommittee members include Dr. Dilsizian, Mr. Green, 13 Ms. Martin as the chair, Mr. Sheetz, Ms. Shober, and 14 Ms. Weil. And the staff resource for this is Maryann 15 Ayoade.
16 Do you agree?
17 CHAIRMAN PALESTRO: Yes.
18 MS. JAMERSON: For item 5, the ACMUI 19 endorsed the Germanium-68/Gallium-68 Generator 20 Licensing Guidance, Revision 1 Subcommittee report and 21 the recommendations therein.
22 Do you agree?
23 CHAIRMAN PALESTRO: Yes.
24 Question: Can this item now be closed or 25 not? No. Can you explain why, Ms. Holiday, again?
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79 1 MS. HOLIDAY: Sure. So at the present 2 time, this is ACMUI providing its recommendations for 3 revisions to the Germanium/Gallium-68 Generator 4 Licensing Guidance. So that is being provided to the 5 NRC staff and the working group, Agreement State 6 Working Group for them to disposition and, if they 7 agree, make changes to the guidance with respect to 8 the recommendations that the subcommittee provided.
9 And then after the guidance has been 10 finalized, a memorandum should be distributed to the 11 ACMUI to inform you of how they dispositioned your 12 recommendations.
13 So this will stay open until 1) the 14 guidance comes out; and 2) the memorandum is provided 15 to the ACMUI.
16 CHAIRMAN PALESTRO: Thank you.
17 MR. EINBERG: Excuse me, Dr. Palestro.
18 Sophie, just to lessen your bureaucracy 19 around issuing a memorandum, once we issue the 20 licensing guidance, is there any reason that this 21 couldn't be closed, rather than waiting for a 22 memorandum?
23 MS. HOLIDAY: Mr. Einberg, this was a 24 recommendation, though not formally captured in the 25 recommendation chart, that came from the ACMUI several NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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80 1 years ago. And they requested a memorandum so that 2 they could know exactly how the recommendations were 3 dispositioned. And because of that, they requested 4 that these items remain open until that memorandum 5 comes to them.
6 MR. EINBERG: I see. Okay, thank you.
7 MS. HOLIDAY: So in my haste to put this 8 up, I did not put any edits that the committee just 9 voted on for the Bylaws Subcommittee. So I am going 10 to have to read from my sticky note. The language you 11 see on this screen is not what I am reading.
12 So item 6 is that the ACMUI endorsed the 13 ACMUI Bylaws Subcommittee report with the caveat that 14 the report be amended to remove the phrase in these 15 instances and to add language about the ACMUI chairman 16 will serve on the subcommittee at the subcommittee's 17 discretion.
18 Additionally, the report will be amended 19 in Section 4.1 to reference the OGE reference that 20 will be provided by the Office of General Counsel.
21 This was unanimously approved by the 22 ACMUI. The motion was put forth by Dr. Dilsizian and 23 seconded by Ms. Martin. However, it should be noted 24 that Dr. Palestro abstained from the vote so that his 25 vote would not present as a conflict of interest.
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81 1 Did I accurately capture the committee's 2 recommendations?
3 Yes, Dr. Schleipman.
4 MEMBER SCHLEIPMAN: I think you missed 5 that we were removing the prior addition of spelling 6 out the financial conflicts of interest.
7 MS. HOLIDAY: Yes, you are absolutely 8 right. Yes, you are correct.
9 So with that, does the committee agree?
10 Okay.
11 Another item not captured on here was that 12 the NRC staff agreed to add language specifically 13 about the conflict of interests in our opening remarks 14 at every ACMUI meeting.
15 Does the committee agree? Thank you.
16 Another item not captured on here -- I'm 17 sorry. Oh.
18 Another item not captured on here is that 19 the ACMUI recommended that the NRC staff invite the 20 NNSA to present at the fall 2019 ACMUI meeting to 21 review its plans for isotope utilization in the United 22 States.
23 Does the ACMUI agree?
24 CHAIRMAN PALESTRO: Yes.
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82 1 back to you, Ms. Jamerson.
2 MR. EINBERG: Ms. Jamerson and Ms.
3 Holiday, can we add a column or can we have an action 4 item to add a column to this table with a target date 5 for completion?
6 MS. HOLIDAY: Yes. Does that need to be 7 made a motion or captured?
8 MR. EINBERG: I think we discussed it or 9 the ACMUI members discussed it. We committed to that.
10 So I'm not sure if there needs to be a motion or not 11 but I think that would be a useful item for tracking 12 these items.
13 CHAIRMAN PALESTRO: Rather than debating 14 whether we need a motion, why don't we just make one?
15 This way, it is definitive.
16 So can we have a motion to add an extra 17 column on our recommendations and action items that 18 will include the anticipated date of completion? Is 19 that correct, sir?
20 MR. EINBERG: That's correct.
21 CHAIRMAN PALESTRO: Okay.
22 Mr. Ouhib?
23 MEMBER OUHIB: Yes, I make the motion.
24 CHAIRMAN PALESTRO: Second?
25 (No audible response.)
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83 1 CHAIRMAN PALESTRO: Any discussion?
2 All in favor?
3 All right, any opposed?
4 Thank you.
5 MS. HOLIDAY: So point of clarification.
6 Is this a target date of completion for NRC staff 7 action?
8 MR. EINBERG: Yes.
9 MS. HOLIDAY: Thank you. So, for the 10 record.
11 MS. JAMERSON: Also not listed on this is 12 Dr. Palestro formed a new subcommittee. The charge:
13 for improving ACMUI's institutional memory.
14 Dr. Schleipman is the chair. Other 15 subcommittee members include Dr. Schleipman as the 16 chair, Ms. Shober, Ms. Weil, Dr. Ennis, Dr. O'Hara, 17 and Kellee Jamerson as the NRC staff resource.
18 Does the ACMUI agree?
19 CHAIRMAN PALESTRO: Yes.
20 MS. JAMERSON: And the last item is the 21 ACMUI tentatively scheduled its fall 2019 meeting for 22 September 11th and 12th, 2019. The alternate date is 23 September 10th and 11th, 2019.
24 Does the ACMUI agree?
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84 1 closing.
2 MEMBER OUHIB: Kellee, when do you 3 anticipate to have a final date for the meeting 4 between the two?
5 MS. JAMERSON: By next month.
6 CHAIRMAN PALESTRO: All right. Are there 7 any other items, Committee? No.
8 Just before we adjourn, just to remind 9 especially the new members, and obviously to help a 10 couple of you with the hotel rooms, but I would 11 suggest that you make your reservations ASAP. I 12 learned the hard way for my first meeting and since 13 then, as soon as this meeting ends, I go and make my 14 reservations for both meeting dates and then cancel 15 the one that we're not going to use.
16 So all right, with that, the meeting 17 concludes. It is adjourned. I thank you all and we 18 will see you again in September.
19 (Whereupon, the above-entitled matter went 20 off the record at 2:13 p.m.)
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