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Transcript of Advisory Committee on the Medical Uses of Isotopes, Open Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Advisory Committee on the Medical Uses of Isotopes: Open Session Docket Number: (n/a) Location: Rockville, Maryland Date: Tuesday, October 28, 2008 Work Order No.: NRC-2476 Pages 1-340 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + + 4 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 5 MEETING 6 OPEN SESSION 7 + + + + + 8 Tuesday 9 October 28, 2008 10 + + + + + 11 The meeting came to order at 8:00 a.m. in T2B3 12 of White Flint 2. Richard J. Vetter, PhD, Vice 13 Chairman, presiding. 14 ACMUI MEMBERS PRESENT: 15 RICHARD J. VETTER, PHD, VICE CHAIRMAN 16 DOUGLAS F. EGGLI, MD, MEMBER 17 DARRELL R. FISHER, PHD, MEMBER 18 DEBBIE B. GILLEY, MEMBER 19 RALPH P. LIETO, MEMBER 20 STEVEN R. MATTMULLER, MEMBER 21 SUBIR NAG, MD, MEMBER 22 ORHAN H. SULEIMAN, PHD, MEMBER 23 BRUCE R. THOMADSEN, PHD, MEMBER 24 WILLIAM A. VAN DECKER, MD, MEMBER 25 JAMES S. WELSH, MD, MEMBER NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 2 1 PRESENT: (cont.) 2 MICKEY GUIBERTEAU, MD, DIAGNOSTIC RADIOLOGIST 3 4 NRC STAFF PRESENT: 5 KIMYATA MORGAN BUTLER 6 CHRIS EINBERG, DESIGNATED FEDERAL OFFICER 7 CINDY FLANNERY, ALT DESIGNATED FEDERAL OFFICIAL 8 OSSY FONT 9 VINCENT HOLAHAN 10 DONNA-BETH HOWE, PHD 11 HARRIET KARAGIANNIS 12 DORIS LEWIS 13 ROBERT LEWIS, DIRECTOR 14 JIM LUEHMAN, DEPUTY DIRECTOR 15 ANGELA MCINTOSH 16 GRETCHEN RIVERA-CAPELLA 17 TERRY REIS, DEPUTY DIRECTOR 18 ASHLEY TULL 19 DUANE WHITE 20 RONALD ZELAC, PHD 21 22 MEMBERS OF THE PUBLIC PRESENT: 23 ROY BROWN, CORAR 24 TOM BURNETT, MDS NORDION 25 WILL DAVIDSON, UPENN NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 3 1 PRESENT (cont.): 2 RICHARD EATON, MITA 3 LYNNE FAIROBENT, AAPM 4 EMILY GARDNER, ASNC 5 MIKE PETERS, ACR 6 DOUG PFEIFFER, AAPM 7 RICHARD MARTIN, ASTRO 8 REED SELWYN, UNIF SVCS UNIV OF HLTH SCI 9 HARRY SKENE, GEISINGER 10 ANN WARBICK-CERONE, MDS NORDION 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 4 1 TABLE OF CONTENTS 2 AGENDA ITEM PAGE 3 Revisions of the NRC Radiation Protection 4 Requirements and Potential Impacts to the 5 Medical Community . .7 6 Potential Rulemaking and Associated 7 Regulatory Information Summary Regarding 8 Multiple RSO on a Medical Use License . 48 9 Status of Technical Basis for 10 Follow-up to the Ritenour Petition. 60 11 Status of Commission Paper for 12 Modifying Training and Experience 13 Attestation requirements. 68 14 Status of Current and Future 15 10 CFR Part 35 Rulemaking . .107 16 Potential Changes to 10 CFR Part 35 . .126 17 Medical Nuclear Materials Events. .183 18 A Patient's Perspective . .308 19 Adjourn 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 5 1 P-R-O-C-E-E-D-I-N-G-S 2 8:07 a.m. 3 VICE CHAIR VETTER Good morning, everyone. 4 My name is Richard Vetter. I'll be chairing the 5 meeting this morning. Dr. Malmud was called away on 6 a family emergency. 7 Yesterday was a long day for us, so if the 8 weather is any indication this morning, we're going to 9 breeze right through the agenda, but we do want to, 10 before we begin -- and let me explain, we will be 11 moving things around a little bit in order to pick up 12 those papers -- those presentations that we missed 13 yesterday. We'll deal with that as we go. 14 First, as you know, yesterday, we had a 15 presentation on the shortage -- the shortage of 16 medical isotopes and it was toward the end of the day 17 and we were all rather tired and we sort of left it on 18 the table after the presentations. So just to go back 19 for just five minutes, we would like to put a motion 20 on the table indicating our support of the issue. 21 Steve Mattmuller has the motion. 22 MR. MATTMULLER: Steve Mattmuller. "The 23 US moly supply for technetium 99 M generators 24 currently is extremely fragile. The ACMUI strongly 25 encourages the NRC to; one, continue supporting the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 6 1 exportation of H highly enriched uranium material for 2 Moly-99 targets used by international suppliers." 3 MS. TULL: Will you read the beginning? 4 Sorry. 5 VICE CHAIR VETTER Read it a little slower 6 and they'll type it as we go. 7 MR. MATTMULLER: Okay. 8 VICE CHAIR VETTER Why don't you just read 9 it and then give her the notebook? 10 MR. MATTMULLER: All right, and then 11 number two, "Provide all possible help towards the 12 development of US suppliers of Moly-99." 13 VICE CHAIR VETTER That's a motion. Is 14 there a second? 15 MS. GILLEY: Second. 16 VICE CHAIR VETTER Debby Gilley seconds. 17 Discussion? I don't think it's very controversial. 18 It's just basically saying we support continued use of 19 HEU and the -- encourage the agency to provide 20 whatever help it can in moving the issue forward. Dr. 21 Welsh? 22 DR. WELSH: We're saying that we're 23 encouraging the continued shipment of HEU for the 24 production of the moly which is a critical aspect for 25 us as medical practitioners that the technetium 99 is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 7 1 available but the HEU remains a concern and there have 2 been petitions put forth to encourage suppliers to 3 switch from HEU to LEU. It may not happen. It may 4 not be as easy as just asking for it, but I think that 5 we should continue to encourage that ultimately these 6 international producers use LEU rather than HEU. 7 VICE CHAIR VETTER Dr. Fisher? 8 DR. FISHER: I'd like to comment on that. 9 Earlier this year in May, I attended the Sixth 10 International Conference on Isotopes in Seoul, Korea. 11 There was substantial discussion of the production of 12 Moly-99 using high and low enriched uranium targets 13 and one of the most interesting comments made in the 14 opening plenary session by the representative from 15 South Africa, his laboratory name I can't quite 16 remember. His name is difficult to pronounce. But he 17 made the comment that although it's feasible to 18 produce Moly-99 using low enriched targets, it is not 19 commercially viable without substantial federal 20 subsidies. 21 You're looking at much larger costs to 22 produce Moly-99 using low enriched uranium for reasons 23 mentioned yesterday. It cannot succeed on a 24 commercial scale without substantial federal subsidies 25 from the host country. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 8 1 VICE CHAIR VETTER Other discussion? Yes. 2 DR. GUIBERTEAU: I know the -- 3 VICE CHAIR VETTER Your name again, 4 please? 5 DR. GUIBERTEAU: I'm sorry, Mickey 6 Guiberteau. I'm a diagnostic radiologist 7 representative. I know there's a subtle difference 8 about this and to provide support for the development 9 of US suppliers of Moly-99. There are a number of 10 suppliers but the producers actually are overseas. So 11 having more suppliers doesn't necessarily help us and 12 I would like to see, perhaps, that word "supplier" 13 changed to "producers." 14 MS. GILLEY: Do you accept that as a 15 friendly amendment? 16 MR. MATTMULLER: I accept that, yes. 17 MS. GILLEY: I accept that as a second. 18 VICE CHAIR VETTER It's been accepted as 19 a friendly amendment to the motion to change 20 "suppliers" to "producers". 21 DR. GUIBERTEAU: Actually, I was thinking 22 in the second part, but both would be fine. 23 VICE CHAIR VETTER Other discussion? All 24 those in favor of the motion, raise one hand. One, 25 two, three -- it is unanimous? It is unanimous. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 9 1 Thank you very much. Okay, now back to the agenda, 2 we'll be starting on Tuesday, October 28th the agenda 3 beginning at 8:00 o'clock. We welcome Dr. Donald Cool 4 and then the 9:00 o'clock presentation by Cindy 5 Flannery will be cut from the agenda and we will deal 6 with that by teleconference. And then we will go 7 back, pick up Dr. Zelac's presentations from yesterday 8 and he will have those two presentations plus item 14.
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