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1Official Transcript of Proceedings23NUCLEAR REGULATORY COMMISSION45678Title:9Meeting of the Advisory Committee on theMedical Uses of Isotopes101112Docket Number:(n/a)Location:teleconferenceDate:Wednesday, October 28, 2015Work Order 32333435NEAL R. GROSS AND CO., INC.Court Reporters and Transcribers1323 Rhode Island Avenue, N.W.Washington, D.C. 20005(202) 234-443336UNITED STATES OF AMERICAPages 1-39

21NUCLEAR REGULATORY COMMISSION2 3ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES4 5TELECONFERENCE6 7WEDNESDAY, OCTOBER 28, 20158 9Themeetingwasconvenedby10teleconference, at 2:00 p.m. Eastern Daylight Time,11Philip O. Alderson, ACMUI Chairman, presiding.12MEMBERS PRESENT:13PHILIP O. ALDERSON, M.D., Chairman14PAT B. ZANZONICO, Ph.D., Vice Chairman15FRANCIS16Representative17VASKEN DILSIZIAN, M.D., Nuclear Cardiologist18RONALD D. ENNIS, M.D., Radiation Oncologist19STEVEN R. MATTMULLER, Nuclear Pharmacist20MICHAEL D. O'HARA, Ph.D., FDA Representative21CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine22Physician23JOHN H. SUH, M.D., Radiation Oncologist24LAURA M. WEIL, Patients’ Rights Advocate25NON-VOTING: DARLENE F. METTER, M.D., DiagnosticM.COSTELLO,AgreementStateNEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

rapyMedical45NRC STAFF PRESENT:JOSEPHINE PICCONE, Ph.D., Director, Division of6Material Safety, State, Tribal and Rulemaking7Programs8DOUGLAS BOLLOCK, Designated Federal Officer9SOPHIE HOLIDAY, Alternate Designated Federal10Officer, ACMUI Coordinator11MARYANN ABOGUNDE, NMSS/MSTR/MSEB12ASHLEY COCKERHAM, NMSS/MSTR/MSEB13SAID DAIBES, Ph.D., NMSS/MSTR/MSEB14ANTHONY DELAMOTTE, NMSS/MSTR/MSEB15SARA FORSTER, R-III/DNMS/MLB16MICHAEL FULLER, NMSS/MSTR/MSEB17JEFF GRIFFIS, OCHCO/ADHRTD/STTB18LATISCHA HANSON, RIV/DNMS/NMSB-B19VINCENT HOLAHAN, Ph.D., NMSS/MSTR20ESTHER HOUSEMAN, OGC/GCLR/RMR21DONNA-BETH HOWE, Ph.D., NMSS/MSTR/MSEB22ERIC KENNEDY, RIII/DNMS/MLB23PENNY LANZISERA, RI/DNMS/MB24DENNIS O’DOWD, RIII/DNMS/MIB25GRETCHEN RIVERA-CAPELLA, NMSS/MSTR/MSEB26MEMBERS OF THE PUBLIC PRESENT:NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

41RICH BEAUMAN, Oregon Health Authority2MIKE BLAKE, American Nuclear Society3ISABELLE BUSENITZ, Kansas Department of Health4and Environment5JEFF COLVIN, American Association of Physicists6in Medicine7PETER CRANE, unaffiliated8JERRY CUTTLER, unaffiliated9VICTOR DIAZ, New Mexico Environment Department10Radiation Control11STEPHEN12Medical Center13WILLIAM DUNCAN, Texas Department of State Health14Services15CHUCK FLYNN, Texas Department of State Health16Services17SANDRA18Agency19WENDY GALBRAITH, University of Oklahoma Health20Sciences Center21HILARY HASKINS, Oregon Health Authority22SCOTT KNISHKA, University of Wisconsin School of23Medicine and Public Health Radiopharmaceutical24Production Facility25RICHARD LAMBOI, Texas Department of State nationalDeaconessAtomicEnergyNEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

1DARYL LEON, Oregon Health Authority2SAM LEVERITT, Cardinal Health3MARVIN LEWIS, unaffiliated4RICHARD5Physicists in Medicine6JOSEPH7Environmental Quality8JUDITH9Environmental AEL SHEETZ, University of Pittsburgh11JEFFRY SIEGEL, Nuclear Physics Enterprises12MICHAEL STABIN, Vanderbilt University13DAVID STEPHENS, Arkansas Department of Health14MIKE15Control16DAVID STRADINGER, North Dakota Department of17Health, Radiation Control18BRUCE THOMADSEN, University of Wisconsin19CINDY TOMLINSON, American Society of Radiation20Oncology21NICOLE TRAPHAN, Texas Department of State Health22Services23ED24Environmental eyofRadiationDepartmentofNEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

61C O N T E N T S2Opening by Dr. Alderson.73Discuss the ACMUI Subcommittee Report on the4Review and Comments of Petitions for5Rulemaking (PRM)-20-28, 20-29, and 20-30,6"Linear No-Threshold Model and Standards for7Protection Against Radiation".148Adjournment by Dr. Alderson.399Comments Submitted by P. Crane.4110Comments Submitted by J. Siegel.77NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

71P-R-O-C-E-E-D-I-N-G-S2(2:03 p.m.)3CHAIRMAN ALDERSON:Thank you.4Dr. Phil Alderson.5on the linear no-threshold issue.6currently be the new Chair of the ACMUI.This isI am the Chair of this subcommitteeI also happen to7So I'd like to welcome everyone to this8teleconference to discuss the ACMUI's comments nst tion12At this time, and before we proceed, I'd13like to turn the meeting over to Mr. Doug Bollock of14the NRC for some opening remarks.15MR. BOLLOCK:Thank you, Dr. Alderson.16As the designated federal officer for this meeting, I17am pleased to welcome you to this public meeting of the18Advisory Committee on the Medical Uses of Isotopes.19My name is Doug Bollock.I am the Branch20Chief of the Medical Safety and Events Assessment21Branch, but I've been designated as the federal officer22for this advisory committee in accordance with 10 CFR23Part 7.11.2425Present today as the alternate AL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

ttee.It is being held in accordance with the4rules and regulations of the Federal Advisory Committee5Act and Nuclear Regulatory Commission.6This meeting is being transcribed by the7NRC, and it may also be transcribed or recorded by8others.9This meeting was announced on September108th, 2015 in edition of the Federal Register Volume 8011--12(Telephonic ello, you need to mute your phone.15MEMBER COSTELLO:16MR. BOLLOCK:17As I said, this meeting was announced inSeptember8th,I am sorry.Thanks, Frank.18the2015editionoftheFederal19Register, Volume 80, pages 53896 through 53897.20The function of the committee is to advise21the staff on issues and questions that arise in the22medical23provides counsel to the staff but does not determine24or direct the actual decisions of the staff or NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

91The NRC solicits the view of the committee2and values their opinions.3possible, we try to reach a consensus on the procedural4issue that we will discuss today but also recognize5there may be minorities or dissenting opinions.6have such opinions, please allow them to be read into7the record.89I request that wheneverAt this point, I'd like to perform a rollcall of ACMUI members participating today.10Dr. Phil Alderson, the Chairman?11CHAIRMAN ALDERSON:12MR.13BOLLOCK:Present.Thankyou.VICE CHAIRMAN ZANZONICO:15MR.BOLLOCK:ThankCHAIRMAN ALDERSON:Present.you.Mr.FrankFrank is still onmute.1920PatCostello?1718Dr.Zanzonico, Vice Chairman?1416If youMR.BOLLOCK:Yes,weheardFrank.Frank, are you --21MEMBER COSTELLO:Present.22MR. BOLLOCK:23Dr. Vasken Dilsizian?24(No audible response.)25MR. BOLLOCK:Thank you, Frank.Okay.Moving on.Dr.NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

101Ronald Ennis?2MEMBER ENNIS:3MR.4CHAIRMAN ALDERSON:MR. BOLLOCK:8CHAIRMANALDERSON:--Mr. Steve Mattmuller?12MEMBER MATTMULLER:13MR. BOLLOCK:Okay, thank you.Present.Thank you.Dr. MichaelO'Hara?15(No audible r Palestro?18(No audible response.)19MR. BOLLOCK:Okay.Moving on, Dr. JohnSuh?21(No audible response.)22MR. BOLLOCK:23undergoingrecovery from an accident.1120SueOkay.MR. BOLLOCK:17Dr.She will not be here.1014you.She is --79ThankLanghorst?56BOLLOCK:Present.All right.And moving on,Ms. Laura Weil?24MEMBER WEIL:Present.25MR. BOLLOCK:Thank you.NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

1112DR. METTER:Hello.Metter, and I am here.3MR. BOLLOCK:4Okay.5This is DarleneThanks, Dr. Metter.And just going through again, wehave Dr. Dilsizian?6MS. HOLIDAY:I'd like to point out that7Dr. Vasken Dilsizian, Dr. Michael O'Hara, and Dr.8Christopher Palestro are on the GoToWebinar.9MR. BOLLOCK:10Okay.So are Drs. O'Hara, Palestro, or Dilsizian11able to speak on the teleconference?12MS. HOLIDAY:13They ought to be able to, butI am not sure if they have called in yet.14MR. BOLLOCK:15All right.Okay.We only have six members.We16need seven for a quorum, but we will check back just17so Drs. Dilsizian, Palestro, O'Hara, if you hear us,18just when you have the chance, let us know that you are19present for a quorum.20Thank you.Also on the phone, we have Dr. Metter, and21I also heard Mr. Zouhir Ouhib.22been selected as our ACMUI diagnostic radiologist, and23Mr. Zouhir Ouhib has been selected as our ACMUI medical24physicist.25Dr. Darlene Metter hasBoth Dr. Metter and Mr. Ouhib are pendingNEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

121security clearance but may participate in this meeting.2However, they both do not have voting rights at this3time.4I now ask NRC staff members who are present5to identify themselves.6in the room here, going around to my right.78MR.FULLER:MikeFuller,MedicalRadiation Safety Team, Team Leader.910I will start with individualsMS. ABOGUNDE:Maryann Abogunde, MedicalRadiation Safety Team.11DR. DAIBES:12MS. HOUSEMAN:Esther Houseman, attorney,DR. HOLAHAN:Dr. Vincent Holahan, Senior13OGC.1415Level Advisor.1617MR.DELAMOTTE:AnthonyDelamotte,Medical Team, NRC.1819Said Daibes, Medical Team.DR. HOWE:Dr. Donna-Beth Howe, r, Division of Material Safety, State, Tribal,22and Rulemaking.23MR. BOLLOCK:24Next, we have any NRC regional offices.25Thank you.Do we have anyone from Region I?NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

131(No audible response.)2MR. BOLLOCK:3Okay.Hearing none, do wehave anyone on the call from Region III?4(No audible response.)5MR. BOLLOCK:6All right.have anyone on the call from Region IV?7(No audible response.)8MR. BOLLOCK:910MS. COCKERHAM:Ashley Cockerham, MedicalTeam.MR. BOLLOCK:14MS. HOLIDAY:Thank you.Sophie Holiday, MedicalTeam.1617Is there -- is therecalling in remotely?1315Okay.anyone else from our NRC Headquarters office that are1112MR. BOLLOCK:Thank you.(No audible response.)19MR. BOLLOCK:20MEMBER O'HARA:MR.This is Mike O'Hara.I amBOLLOCK:Thankyou,Dr.O'Hara,appreciate it.2425Thank you.on the line now.2223Anyone else?Any other NRC employees calling in?1821Moving on, do weMEMBER DILSIZIAN:And Vasken Dilsizianon the line now.NEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433

141MEMBER SUH:2MR. BOLLOCK:3Dr. Suh.4of over seven members.And also John Suh.Thank you Dr. Dilsizian andOkay, so we have confirmed we do have a quorum5Thank you.And members of the public who notified ninthetheFor those of you who did not provide iday@nrc.gov,11H-O-L-I-D-A-Y at N-R-C dot gov, or at her number,12404-997-4691.13that'sMs.dotWe have a bridge line available, and that14number is 1-888-889-5011.The passcode to access the15bridge line is 7499997 followed by the pound sign.16This meeting is also using the GoToWebinar17application to view this presentation and handouts in18real19www.gotomeeting.com and searching the meeting he purpose of this meeting is to discuss22the ACMUI subcommittee's report on the ACMUI review and23comments of three Petitions for Rulemaking, Petition24for Rulemaking 20-28, 20-29, and 20-30, on linear25no-threshold model and standard protection againstNEAL R. GROSS(202) 234-4433COURT REPORTERS AND TRANSCRIBERS1323 RHODE ISLAND AVE., N.W.WASHINGTON, D.C. 20005-3701(202) 234-4433