ML19231A155
| ML19231A155 | |
| Person / Time | |
|---|---|
| Issue date: | 06/10/2019 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Jamerson, Kellee | |
| References | |
| NRC-0374 | |
| Download: ML19231A155 (93) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a)
Location: Rockville, Maryland Date: Monday, June 10, 2019 Work Order No.: NRC-0374 Pages 1-93 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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TELECONFERENCE
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MONDAY, JUNE 10, 2019
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The meeting was convened via teleconference at 2:00 p.m., Christopher Palestro, ACMUI Chairman, presiding.
MEMBERS PRESENT:
CHRISTOPHER J. PALESTRO, M.D., Chairman DARLENE F. METTER, M.D., Vice Chairman VASKEN DILSIZIAN, M.D., Member RICHARD L. GREEN, Member MELISSA C. MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member A. ROBERT SCHLEIPMAN, Ph.D., Member MICHAEL SHEETZ, Member MEGAN L. SHOBER, Member LAURA M. WEIL, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 HARVEY B. WOLKOV, M.D., Member NRC STAFF PRESENT:
ROBERT LEWIS, Deputy Director, NMSS CHRISTIAN EINBERG, Designated Federal Officer, Chief, Medical Safety and Events Assessment Branch, NMSS/MSST MARYANN AYOADE, NMSS/MSST/MSEB STEPHANIE BUSH-GODDARD, RES/DSA/RPB COLLEEN CASEY, R-III/DNMS/MLB SAMANTHA CRANE, OCM/DAW SAID DAIBES, NMSS/MSST/MSEB LISA DIMMICK, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB JULIE EZELL, OGC/GCHA/AGCNRP CASSANDRA FRAZIER, R-III/DNMS/MLB ROBERT GALLAGHAR, R-I/DNMS/MLAB SOPHIE HOLIDAY, NMSS/MSST/MSEB ESTHER HOUSEMAN, OGC/GCLR/RMR DONNA-BETH HOWE, PhD, NMSS/MSST/MSEB KELLEE JAMERSON, ACMUI Coordinator, NMSS/MSST/MSEB CYNTHIA JONES, OCM/AXC HARRIET KARAGIANNIS, RES/DE/RGGIB SARAH LOPAS, NMSS/MSST/MSEB MINH-THUY NGUYEN, RES/DSA/RPB NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 PATRICIA PELKE, R-III/DNMS/MLB HALFON SCHLOM, RES VERED SHAFFER, RES/DSA/RPB DANIEL STROHMEYER, R-III/DNMS/MLB KATHERINE TAPP, PhD, NMSS/MSST/MSEB ALEXUS WILLIS, RES/DE/CMB IRENE WU, NMSS/MSST/MSEB MEMBERS OF THE PUBLIC PRESENT:
JAIME BARNES, Cook Childrens Medical Center ROLAND BENKE, Renaissance Code Development, LLC KENDALL BERRY, Fox Chase Cancer Center JANICE CAMPBELL, Beaumont Health PETER CRANE, Unaffiliated DAVID CROWLEY, North Carolina Department of Health and Human Services, Radiation Protection Section BRIAN ERASMUS, British Technology Group SANDY GABRIEL, Unaffiliated BENNETT GREENSPAN, M.D., Society of Nuclear Medicine and Molecular Imaging (SNMMI)
MIGUEL de la GUARDIA, Cook Childrens Medical Center DAVID HAMBY, Renaissance Code Development, LLC ALAN JACKSON, Henry Ford Health System BRANDON JURAN, Minnesota Radioactive Materials NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 Unit LINDA KROGER, University of California at Davis TYLER KRUSE, Minnesota Radioactive Materials Unit ALEXIS LAVIOLETTE, Boston Childrens Hospital, Harvard Medical School RALPH LIETO, St. Joseph Mercy Health System TERRY LINDLEY, University of Cincinnati CINDI LUCKETT-GILBERT, Unaffiliated CAROL MARCUS, Ph.D., M.D., University of California at Los Angeles (UCLA)
RICHARD MARTIN, AAPM CANDI MCDOWELL, University of Pennsylvania CHRIS MITCHELL, Kettering Health JOSE MORALES, M.D., Unaffiliated MICHAEL PETERS, American College of Radiology (ACR)
CARMINE PLOTT, Novant Health ARIA RAZMARIA, UCLA Medical Center SAMUEL RHOADES, IV, Mercy Health GLORIA ROMANELLI, ACR JEFFRY SIEGEL, Ph.D, Nuclear Physics Enterprises EUGENE SILVESTRINI, Northwell Health ANDRES SINISTERRA, UConn Health JOE STEINER, Henry Ford Health System NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 CINDY TOMLINSON, American Society of Radiation Oncology JOSEPH WISSING, St. Joseph Mercy Health System MIYUKI YOSHIDA-HAY, Northwell Health ANDREW ZIMNOCH, University of Pennsylvania, Environmental Health & Radiation Safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 P R O C E E D I N G S 2 2:02 p.m.
3 MR. EINBERG: Good afternoon, everyone.
4 As the Designated Federal Officer for this meeting, 5 I am pleased to welcome you to the public meeting of 6 the Advisory Committee on the Medical Uses of Isotopes.
7 My name is Chris Einberg. I'm the Chief of the Medical 8 Safety and Events Assessment Branch, and I've been 9 designated as the federal officer for this advisory 10 committee meeting in accordance with 10 CFR 7.11.
11 Present today, we have Lisa Dimmick, our 12 Medical Radiation Safety Team Leader, and Kellee 13 Jamerson, our ACMUI coordinator, as Designated Federal 14 Officers for the ACMUI.
15 This is an announced meeting of the 16 Committee that is being held in accordance with the 17 rules and regulations of the Federal Advisory Committee 18 Act and the Nuclear Regulatory Commission. This 19 meeting is being transcribed by the NRC, and it may 20 also be transcribed or recorded by others. The meeting 21 was announced in the May 9th, 2019 edition of the Federal 22 Register, Volume 84, page 20439.
23 The purpose of this meeting is to discuss 24 the revised ACMUI bylaws and the draft report of the 25 ACMUI Regulatory Guide 8.39 Subcommittee. In its NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 report, the Subcommittee provides recommendations with 2 respect to Phase 1 of the revisions to the Reg Guide 3 8.39, Release of Patients Administered Radioactive 4 Material.
5 The function of the ACMUI is to advise staff 6 on the issues and questions that arise on the medical 7 use of byproduct material. The Committee provides 8 counsel to the staff but does not determine or direct 9 the actual decisions of the staff or the Commission.
10 The NRC solicits the views of the Committee and values 11 their opinions. I request that, whenever possible, 12 we try to reach a consensus on the various issues that 13 we will discuss today, but I also recognize there may 14 be minority or dissenting opinions. If you have such 15 opinions, please allow them to be read into the record.
16 At this point, I'd like to perform the roll 17 call of the ACMUI members participating today. Dr.
18 Christopher Palestro, Chairman, nuclear medicine 19 physician.
20 CHAIRMAN PALESTRO: Present.
21 MR. EINBERG: Dr. Darlene Metter, Vice 22 Chairman, Diagnostic Radiologist.
23 VICE CHAIRMAN METTER: Here.
24 MR. EINBERG: Dr. Vasken Dilsizian, 25 Nuclear Cardiologist.
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8 1 MEMBER DILSIZIAN: Here.
2 MR. EINBERG: Dr. Ronald Ennis, Radiation 3 Oncologist.
4 (No audible response.)
5 MR. EINBERG: Mr. Richard Green, Nuclear 6 Pharmacist.
7 MEMBER GREEN: Present.
8 MR. EINBERG: Ms. Melissa Martin, Nuclear 9 Medicine Physicist.
10 MEMBER MARTIN: Here.
11 MR. EINBERG: Dr. Michael O'Hara, FDA 12 Representative.
13 MEMBER O'HARA: Here.
14 MR. EINBERG: Mr. Zoubir Ouhib, Radiation 15 Therapy Physicist.
16 MEMBER OUHIB: Here.
17 MR. EINBERG: Dr. A. Robert Schleipman, 18 Healthcare Administrator.
19 MEMBER SCHLEIPMAN: Present.
20 MR. EINBERG: Mr. Michael Sheetz, 21 Radiation Safety Officer.
22 MEMBER SHEETZ: Present.
23 MR. EINBERG: Ms. Megan Shober, State 24 Government Representative.
25 MEMBER SHOBER: Here.
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9 1 MR. EINBERG: Ms. Laura Weil, Patients' 2 Rights Advocate.
3 (No audible response.)
4 MR. EINBERG: Dr. Harvey Wolkov, Radiation 5 Oncologist.
6 MEMBER WOLKOV: Present.
7 MR. EINBERG: Okay. We have a quorum with 8 at least six members present. I would add that all 9 members of the ACMUI are subject to federal ethics laws 10 and regulations and receive annual training on these 11 requirements. If a member believes that he or she may 12 have a conflict of interest, as that term is broadly 13 used within 5 CFR Part 2635 with regards to an agenda 14 item to be addressed by the ACMUI, this member should 15 divulge it to the Chair and to the DFO as soon as possible 16 before the ACMUI discusses it as an agenda item.
17 ACMUI members must recuse themselves from 18 participating in any agenda item which they may have 19 a conflict of interest unless they've received a waiver 20 or prior authorization from their appropriate NRC 21 official.
22 I now ask that NRC members, staff members 23 who are present to identify themselves. I'll start 24 with the individuals in the room.
25 MR. SCHLOM: Halfon Schlom.
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10 1 MR. EINBERG: Okay.
2 MS. DIMMICK: Lisa Dimmick, Medical 3 Radiation Safety Team Leader.
4 MS. HOUSEMAN: Esther Houseman, Attorney.
5 DR. DAIBES: Said Daibes, Medical Team.
6 MS. HOLIDAY: Sophie Holiday, 7 Enforcement.
8 MS. JAMERSON: Kellee Jamerson, Medical 9 Team.
10 MS. KARAGIANNIS: Harriet Karagiannis, 11 Office of Research.
12 MR. EINBERG: Thank you. Are there NRC 13 members on the phone? Sophie is indicating to me that 14 they're on a muted line and can't say who's on the line.
15 Members of the public who notified Ms.
16 Jamerson that you will be participating in the 17 teleconference will be captured in the transcript.
18 Those of you who did not provide prior notification, 19 please contact Ms. Jamerson at 20 kellee.jamerson@nrc.gov, that's K-E-L-L-E-E, dot, 21 Jamerson, J-A-M-E-R-S-O-N, @nrc.gov or at 22 301-415-7408, at the conclusion of this meeting.
23 We also have a bridgeline available, and 24 that phone number is 888-282-1673. The pass code to 25 access the bridgeline is 6240665.
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11 1 The meeting is also using the GoToWebinar 2 application to view presentations in real-time. You 3 can access this by going to www.gotowebinar.com and 4 searching for the meeting ID 386468939. Let me repeat 5 that: 386468939.
6 Individuals who would like to ask a 7 question or make a comment regarding a specific topic 8 the Committee has discussed should dial *1 to signal 9 the operator that you wish to speak. Please clearly 10 state your first and last name for the record.
11 Comments and questions are typically 12 addressed by the Committee near the end of the 13 presentation. After the Committee has fully discussed 14 the topic, we will notify the operator when we are ready 15 for the public comment period of the meeting.
16 I would also like to add that the handouts 17 and agenda for this meeting are available on the NRC's 18 public website.
19 At this time, I ask everyone on the call 20 who is not speaking to please place your phone on mute.
21 If you do not have the capability to mute your phone, 22 please press *6 to utilize the conference line mute 23 and unmute functions. I would also ask everyone to 24 exercise extreme care to ensure that background noise 25 is kept at a minimum, as any stray background sounds NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 can be very disruptive on a conference call this large.
2 At this point, I would like to turn the 3 meeting over to Ms. Lisa Dimmick, who will provide some 4 additional remarks regarding our process for revising 5 Reg Guide 8.39.
6 MS. DIMMICK: Thank you, Chris. Good 7 afternoon. I'm Lisa Dimmick, the Medical Radiation 8 Safety Team Leader. I would like to provide some 9 additional background on the purpose of today's 10 meeting.
11 As you know, the purpose of this meeting 12 is to discuss the revised ACMUI bylaws and the draft 13 report of the ACMUI Regulatory Guide 8.39 Subcommittee.
14 In its report, the Subcommittee provides 15 recommendations with respect to Phase 1 of the revisions 16 of Regulatory Guide 8.39, Release of Patients 17 Administered Radioactive Material.
18 It's important to note and to understand 19 that Regulatory Guide 8.39 is being revised in two 20 phases. Phase 1, updates the patient release guidance, 21 including information for patient instruction and 22 updates to Table 3, Reactivity of the 23 Radiopharmaceuticals that Require Instruction and 24 Records when Administered to Patients who are 25 Breastfeeding an Infant or Child, as well as introduces NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 a new section titled Death of a Patient Following 2 Radiopharmaceutical Administration or Implant. The 3 Phase 2 update will update the dosimetric equations, 4 methodologies, and tables used to calculate dose to 5 members of the public from released patients.
6 The Subcommittee's report and 7 recommendation on this preliminary draft proposed 8 Regulatory Guide 8.39, Revision 1, will only pertain 9 to the Phase 1 update. This preliminary draft was 10 provided to the ACMUI for its review and comment for 11 staff consideration. The NRC staff will evaluate the 12 ACMUI's comments following today's meeting. The draft 13 Reg Guide 8.39 will then be published in the Federal 14 Register for public comment.
15 Thank you. And I will now turn the meeting 16 over to Dr. Palestro.
17 CHAIRMAN PALESTRO: All right. Thank 18 you, Lisa. This is Dr. Palestro. The first item on 19 the agenda is to discuss the revised 2019 Advisory 20 Committee on Medical Uses of Isotopes Bylaws. At this 21 point, I would ask Ms. Weil to provide this.
22 MS. HOLIDAY: Dr. Palestro, this is Sophie 23 Holiday.
24 CHAIRMAN PALESTRO: Yes.
25 MS. HOLIDAY: I was actually going to do NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 the presentation on this, as this is incorporation of 2 the comments that the ACMUI Bylaws Subcommittee 3 provided in its spring meeting, which was unanimously 4 endorsed by the Committee.
5 CHAIRMAN PALESTRO: All right. That's 6 fine.
7 MS. HOLIDAY: Okay. Everyone should be 8 able to see on their screen a copy of the proposed draft 9 bylaws. And the changes in here are both minor 10 editorial, as well as changes that conform to the 11 recommendations that the ACMUI endorsed during its 12 April 2019 meeting here at headquarters.
13 So, what you see here on the screen in 14 yellow highlight, the changes are noted in yellow 15 highlight so that everyone can clearly see what the 16 changes are. This is what I would consider a minor 17 edit, which is to simply update the bylaws to reflect 18 the current name of our division and our office. So, 19 it now reads Division of Material Safety, Security, 20 State and Tribal Programs, MSST, Office of Nuclear 21 Material Safety and Safeguards, NMSS.
22 Here what you see is page three of the 23 bylaws, which is Section 1.3.6. This is directly 24 related to the objective of the previous bylaw 25 subcommittee, which was to review the Chair's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 involvement in subcommittees. The new text reads: In 2 matters where the ACMUI Chair's unique experience and 3 knowledge would be especially informative, the chair 4 may serve on relevant subcommittees. The chair will 5 serve at the discretion of the subcommittee members.
6 However, the ACMUI chair will not chair the 7 subcommittees.
8 Okay. In Section 4, conduct of members, 9 specifically Section 4.1, there has been revised 10 language to reflect the conversation that the ACMUI 11 had related to conflicts of interest. Particularly, 12 the Committee wanted there to be clear distinct language 13 in the bylaws that identifies when ACMUI members must 14 recuse themselves. So, the new text reads as follows:
15 All members of the ACMUI are subject to federal ethics 16 laws and regulations and receive annual training on 17 these requirements. If a member believes that he or 18 she may have a conflict of interest, as that term is 19 broadly used within 5 CFR Part 2635, with regard to 20 an agenda item to be addressed by the ACMUI, this member 21 should divulge it to the Chair and the DFO as soon as 22 possible and before the ACMUI discusses it as an agenda 23 item. ACMUI members must recuse themselves from 24 participating in any agenda item in which they may have 25 a conflict of interest unless they receive a waiver NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 or prior authorization from the appropriate NRC 2 official.
3 This language was provided to us from the 4 Office of General Counsel, as was discussed during the 5 April 2019 ACMUI meeting. The ACMUI voted for us to 6 work with the Office of General Counsel to provide us 7 with the appropriate language, and this is what they 8 have provided.
9 Okay. That concludes the proposed 10 amendments to the bylaws. What I have on the screen 11 here is just to show everybody that, per the bylaw 12 Section 5.1, it states that amendment of these bylaws 13 shall require an affirmative vote of two-thirds of the 14 current ACMUI membership and the concurrence of the 15 director of Nuclear Material Safety and Safeguards.
16 So at this time, Dr. Palestro, I would like 17 to ask if there's a motion on the table to approve the 18 amended bylaws.
19 CHAIRMAN PALESTRO: That's fine. Is 20 there a motion.
21 MEMBER WOLKOV: This is Dr. Harvey Wolkov.
22 So moved.
23 CHAIRMAN PALESTRO: Second?
24 VICE CHAIRMAN METTER: This is Darlene 25 Metter. Second.
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17 1 CHAIRMAN PALESTRO: Any discussion?
2 MS. HOLIDAY: I'm sorry. Go ahead, Dr.
3 Palestro.
4 CHAIRMAN PALESTRO: Any discussion? Ms.
5 Holiday, I'm sorry. You were going to say something 6 and I cut you off.
7 MS. HOLIDAY: That's okay. I was just 8 going to say for the record I have Dr. Wolkov as making 9 the motion and Dr. Metter as seconding.
10 CHAIRMAN PALESTRO: All right. Any 11 discussion? Any comments or discussion from the 12 public?
13 MEMBER OUHIB: Dr. Palestro, this is 14 Zoubir.
15 CHAIRMAN PALESTRO: Yes, Zoubir?
16 MEMBER OUHIB: Just a comment on item 1.3.6 17 where it says the Chair may serve on relevant 18 subcommittees. What level would that be? As a voting 19 member, as a consultant, or what?
20 CHAIRMAN PALESTRO: Given that it's not 21 specified, and Ms. Holiday or Mr. Einberg or Ms.
22 Dimmick, correct me if I'm wrong, would serve on the 23 relevant subcommittee with all of the rights of other 24 members of the subcommittee. That would be my 25 understanding.
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18 1 MEMBER SCHLEIPMAN: Hello, this is Robert 2 Schleipman. The very first sentence mentions that the 3 Chair may vote.
4 MS. HOLIDAY: That is also our 5 understanding.
6 CHAIRMAN PALESTRO: I'm sorry, Ms.
7 Holiday.
8 MS. HOLIDAY: I was saying, Dr. Palestro, 9 that is also our understanding.
10 CHAIRMAN PALESTRO: All right. Thank 11 you. Any other questions or discussion? All right.
12 Hearing none, all in favor.
13 (Chorus of aye.)
14 CHAIRMAN PALESTRO: Any opposed?
15 (No audible response.)
16 CHAIRMAN PALESTRO: Any abstentions?
17 (No audible response.)
18 CHAIRMAN PALESTRO: And, again, as I did 19 at the April meeting, I will abstain, but, once again, 20 I want the record to reflect that my abstention does 21 not in any way indicate my agreement or disagreement 22 with the proposed revisions but rather the fact that 23 this, as the current chair, is a potential conflict 24 of interest for me.
25 MS. HOLIDAY: Thank you so much. Okay.
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19 1 That concludes topic one. Whenever you are ready to 2 proceed to topic two.
3 CHAIRMAN PALESTRO: All right. If we can 4 then move on to topic two, which is the draft proposed 5 Regulatory Guideline 8.39, The Release of Patients 6 Administered Radioactive Materials, Revision 1, Phase 7 1. And, again, just to re-emphasize that Phase 1, which 8 is what we are addressing today, updates patient release 9 guidance, including the information for patient 10 instructions and updates to Table 3, as well as a new 11 section, Death of a Patient Following 12 Radiopharmaceutical Administration or Implants.
13 At this point, I will turn the session over 14 to Mr. Michael Sheetz, Chair of the Subcommittee.
15 MEMBER SHEETZ: Thank you, Dr. Palestro.
16 This is Michael Sheetz. I'd like to provide an 17 overview of the ACMUI Subcommittee comments on the draft 18 proposed Reg Guide 8.39, Release of Patients 19 Administered Radioactive Materials, Revision 1, Phase 20 1.
21 The other subcommittee members are Dr.
22 Vasken Dilsizian, Ms. Melissa Martin, Dr. Robert 23 Schleipman, Ms. Megan Shober, Ms. Laura Weil, and our 24 NRC staff resource, Dr. Said Daibes - Figueroa.
25 For background, the NRC's current Reg Guide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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20 1 8.39 Revision 0 was issued in April of 1997 following 2 the rule change in 10 CFR 35.75 to allow for the release 3 of patients administered radioactive material on a 4 solely dose-based criteria. Since that time, there 5 have been several challenges to the appropriateness 6 of the release criteria and the associated precautions 7 that are required to be provided to minimize radiation 8 exposure to other individuals from the released 9 patient.
10 The NRC requested public comments on the 11 patient release program in 2017 to receive input on 12 whether additional or alternative criteria are needed 13 and to determine whether regulatory changes to the NRC's 14 patient release program are warranted. The NRC also 15 created a web page to provide patients with standardized 16 information on radioactive iodide treatment procedures 17 so that the patients will understand the reason for 18 the procedures, the process, and how to reduce radiation 19 exposure to others.
20 As stated previously, it should be noted 21 that Reg Guide 8.39 is being revised in two phases.
22 This first Phase 1 revision updates the patient release 23 guidance, including information for patient 24 instructions, and updates to Table 3 entitled 25 Activities of Radiopharmaceuticals that Require NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 Instructions and Records When Administered to Patients 2 who are Breastfeeding an Infant or Child.
3 In Phase 2, which will come later, the 4 dosimetric equations, methodologies, and tables used 5 to calculate dose to members of the public from released 6 patients will be updated. The following Subcommittee 7 comments and recommendations only pertain to this Phase 8 1 revision, as we did not address the dosimetric 9 equations and methodologies.
10 In the direct report, we published 11 approximately 40 directed changes pertaining to the 12 wording, items of emphasis, and formatting of the 13 document. In consideration of everyone's time, I will 14 not be repeating these. However, if anyone has a 15 specific question or concern related to any of the 16 direct changes, we will certainly entertain them.
17 I would like to highlight the 18 Subcommittee's main comments and recommendations on 19 the draft reg guide. First, the Subcommittee supports 20 the addition of a table of contents to the Reg Guide 21 and expanding the section on content of instructions 22 to include subsections on pretreatment discussions, 23 patient precautions, patient instructions, and patient 24 acknowledgment of instructions. While we recognize 25 that some of these subsections are not required in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 regulation, they are reasonable components of a strong 2 patient instruction program and will help to assure 3 patient planning and comprehension.
4 Second, in Tables 1 and 2, entitled 5 Activities and Dose Rates for Authorizing Patient 6 Release and When Instruction Should be Provided, these 7 tables should be updated to include the new and 8 potential radionuclides to be used in the future.
9 Third, Table 3 entitled Activities of 10 Radiopharmaceuticals that Require Instructions and 11 Records when Administered to Patients who are 12 Breastfeeding an Infant or Child, also this table should 13 be updated to include the radionuclides activities and 14 recommended duration of interruption of breastfeeding, 15 as contained in the ACMUI Subcommittee report on nursing 16 mother guidelines for medical administration of 17 radioactive materials, final report, dated January 18 31st, 2019.
19 Fourth, in the patient precautions and 20 instructions sections, we support the addition of 21 instructions for evaluation of holding trash to allow 22 for radioactive decay as the landfill will likely detect 23 the radiation and send the trash back to the patient, 24 providing information to a family member or caregiver 25 to contact the treating medical facility if the patient NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 has a medical emergency or passes away, and warning 2 that the patient may trigger the radiation detector 3 alarms at airports and national borders for several 4 weeks or months.
5 Fifth, in the patient precautions and 6 instructions sections, while most of the precautions 7 address contamination control, it should be emphasized 8 that the major source of radiation dose to other 9 individuals will be from external exposure from the 10 patient, and so this should be the primary focus. Also, 11 after completion of the Phase 2 revisions, these 12 sections should also include the recommended time 13 period for following the precautions. While the list 14 of precautions for patients to follow is fairly 15 standardized, the time period to follow these 16 precautions is highly variable.
17 And, sixth, the Subcommittee supports the 18 addition of a new section on death of a patient following 19 radiopharmaceutical administration or implants. Most 20 of our directed changes to this section were to format 21 and organize the information by type of postmortem 22 activity, such as autopsy, embalming, funeral, burial, 23 and cremation. Whichever the event, we feel that the 24 RSO is the primary person to be notified to determine 25 the amount of activity remaining in the deceased NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 patient, determine what precautions should be taken, 2 and to determine if there are any applicable state or 3 municipal restrictions.
4 While there is adequate guidance on the 5 precautions to take to minimize radiation exposure for 6 postmortem activities of a patient who has died after 7 being administered a therapeutic quantity of 8 radioactive material, there is little or no consistent 9 guidance on what retained activity or time period for 10 when the precautions should be followed. The 11 Subcommittee recommends that a dose-based model be 12 developed to provide guidance on when precautions or 13 restrictions would be appropriate following the death 14 of a patient administered a therapeutic quantity of 15 radioactive material.
16 That concludes the Subcommittee report.
17 CHAIRMAN PALESTRO: Comments from the 18 Subcommittee members? Comments from the ACMUI 19 Committee members?
20 VICE CHAIRMAN METTER: This is Darlene 21 Metter. I have a couple of comments to make. I thank 22 you for making the recommendations to comply with the 23 nursing mother guidelines final report.
24 I'd also like to make a comment that there 25 was an item there that talked zirconium-80. I don't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 think that was in the nursing mothers guideline. I 2 think that might have been a typo, so it should be 3 zirconium-89. And also I agree with all the other 4 recommendations which are listed in the table of the 5 nursing mother guidelines.
6 Number two is I just have a question that 7 why did the ACMUI Subcommittee start with the 8 recommendations, why didn't they start with the 9 methodology? Because if thats stage two, there's a 10 change in the methodology, then you'll have to change 11 your appropriate recommendations for the public. And 12 I'm just kind of wondering if maybe you should have 13 done the methodology first to get your exposure limits 14 and then go back and make the recommendations.
15 That's it. Those are my two comments.
16 CHAIRMAN PALESTRO: Mr. Sheetz?
17 MEMBER SHEETZ: It was my understanding 18 that we were to address the revisions from Phase 1 and 19 not comment on the methodologies. That will come in 20 Phase 2.
21 VICE CHAIRMAN METTER: This is Darlene 22 Metter again. It's just that if we change the 23 methodology, then those recommendations will need to 24 be changed also, I suspect. You know what I mean?
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26 1 Dr. Palestro. I think I understand what you're saying, 2 Dr. Metter, and I understand these were the instructions 3 that were given to Mr. Sheetz. I think maybe this is 4 a question that staff is best suited to answer as to 5 why Phase 1 included what it did, as opposed to, say, 6 the methodology first.
7 MS. DIMMICK: Hi, this is Lisa Dimmick, 8 Medical Radiation Safety Team Leader. So, when staff 9 completed its evaluation for patient release at the 10 end of 2017 and going into 2018, we had identified in 11 the Commission paper that Reg Guide 8.39 would be 12 updated in a phased approach, a Phase 1 approach and 13 then the Phase 2. We were also evaluating or responding 14 to previous Commission direction to update Regulatory 15 Guide 8.39 to encompass all of its instructional 16 information on patient release that was included in 17 generic communications and other guidance documents 18 to consolidate it for one location. So, we had 19 resources available to begin a Phase 1 approach to 20 evaluate or include the guidance information, so that 21 was the path we took.
22 CHAIRMAN PALESTRO: Thank you. Does that 23 answer your question, Dr. Metter?
24 VICE CHAIRMAN METTER: I can see what they 25 did, but it just would make it difficult. If there's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 a change in the methodology, then the radiation limits 2 may change and then the instructions may need to change 3 and you'll have to go back and redo the recommendations.
4 That would just be what I would think, but I can see 5 that, you know, what you've put forth as Phase 1 and 6 Phase 2.
7 CHAIRMAN PALESTRO: I understand your 8 point, Dr. Metter, and I think it's a point well taken.
9 At this point, it's moot because it's already begun.
10 It certainly would be something to keep in mind for 11 future revisions.
12 Other comments from the ACMUI?
13 VICE CHAIRMAN METTER: I have another 14 comment. This is Darlene --
15 CHAIRMAN PALESTRO: Yes, Dr. Metter.
16 VICE CHAIRMAN METTER: Regarding the 17 issues with disposable plates for the individual who 18 has received radioactive material and disposable 19 utensils and the making of radioactive waste and setting 20 off landfills, I don't know how many people do this, 21 but I generally do not encourage my patients to use 22 disposable utensils or plates because of that 23 particular concern. And I just have them use regular 24 plates, a regular plate or a set of dishes that they 25 use for themselves and they wash themselves because NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 everything just goes down the drain and you don't have 2 to deal with radioactive waste. And they just put that 3 aside for their sole use during the time that they need 4 to be more careful of their exposures to other people.
5 And I don't know if other individuals recommend this 6 for their patients, and maybe we should actually make 7 that, this is what I would prefer, rather than making 8 radioactive waste that then the patients would have 9 to decay and then that would be more work for them.
10 But if they just wash their dishes, there's no need 11 to hold any disposable items for radioactive decay.
12 CHAIRMAN PALESTRO: Thank you, Dr. Metter.
13 Any comments in response to Dr. Metter's statement?
14 MEMBER SCHLEIPMAN: Robert Schleipman.
15 That was our same practice to recommend to patients, 16 if they're capable of doing so, to wash their own dishes 17 and not discard items that could potentially set off 18 landfill alarms.
19 CHAIRMAN PALESTRO: Thank you, Dr.
20 Schleipman. Other comments?
21 MEMBER MARTIN: This is Melissa Martin.
22 VICE CHAIRMAN METTER: Go ahead, Melissa.
23 MEMBER MARTIN: I was just going to say 24 I would certainly support that as an alternative or 25 a recommended alternative and maybe we can phrase it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 that way. In lieu of using disposable plates and 2 silverware, an option would be to use a designated set 3 of dishes handled only by the patients.
4 VICE CHAIRMAN METTER: This is Darlene 5 Metter. I actually would make that the recommendation.
6 The alternative would be the disposable because I think 7 that would make more sense to me.
8 MEMBER MARTIN: That's fine with me, too.
9 We've used the same recommendation. We've just told 10 them put everything you can, create as little trash 11 as possible by using the alternative method that you've 12 suggested.
13 CHAIRMAN PALESTRO: This is Dr. Palestro.
14 We follow that procedure, as well. We always 15 recommended to patients that, whenever possible, use 16 an isolated set of utensils and dishes and wash them 17 separately, rather than disposable items, for the exact 18 reasons that that's been mentioned.
19 Other comments?
20 MEMBER SHEETZ: This is Mike Sheetz. I 21 agree that the amount of waste that a patient generates 22 should be minimized and disposable should be 23 discouraged, but there will always be potentially some 24 items, you know, diapers, Depends, tissues, and things 25 that will end up potentially in the trash that could NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 trigger a waste alarm. And I guess my point was that 2 the institution should evaluate that potential, 3 depending on their state, and be able to provide 4 guidance to the patient appropriately.
5 In Pennsylvania, all of the landfills have 6 radiation monitors, but they also are permitted to 7 dispose of anything radioactive that has a medical 8 radioisotope. And so it never comes back to the 9 patient. So in Pennsylvania, it really doesn't matter 10 if they generate radioactive trash. It's not going 11 to come back to them. Other states it may be different.
12 And so I think the point that I was trying to make 13 that there's an evaluation of that, you know, by the 14 institution depending on the state they're in.
15 CHAIRMAN PALESTRO: Other comments?
16 Comments from the public?
17 MS. JAMERSON: Dr. Palestro?
18 CHAIRMAN PALESTRO: Yes.
19 MS. JAMERSON: This is Kellee Jamerson.
20 I'd just like to ask Mr. Sheetz if they're going to 21 revise their recommendation.
22 MEMBER SHEETZ: You want me to recite the 23 recommendations?
24 MS. JAMERSON: Are you going to revise per 25 the discussion you just had regarding the utensils, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 1 disposable utensils?
2 MEMBER SHEETZ: I guess we can revise the 3 statement and the instructions -- I don't have it 4 directly in front of me -- to, you know, encourage the 5 use of regular dishware so that it can be washed and 6 not using disposable.
7 CHAIRMAN PALESTRO: Do we have the exact 8 verbiage as it stands now?
9 MEMBER SCHLEIPMAN: Robert Schleipman.
10 It's on page 31 under Section 2.3.3, use dedicated or 11 disposable kitchen utensils and do not share them with 12 others. So dedicated would include their own, I 13 suppose, right?
14 MS. JAMERSON: Correct.
15 VICE CHAIRMAN METTER: This is Darlene 16 Metter. Maybe since we weren't quite sure about it, 17 maybe we should clarify that word dedicated so that 18 the public can understand.
19 CHAIRMAN PALESTRO: I'm sorry. Dr.
20 Schleipman, could I ask you to read that again?
21 MEMBER SCHLEIPMAN: Yes. It's, quote, 22 use dedicated or disposable kitchen utensils and don't 23 share them with others, end quote.
24 MS. HOLIDAY: Dr. Palestro, this is 25 Sophie.
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32 1 CHAIRMAN PALESTRO: Yes.
2 MS. HOLIDAY: If I could add on, the page 3 right before that also says under the fourth sub-bullet, 4 encourage the use of kitchen utensils dedicated to the 5 patient, not shared with other household members, and 6 wash separately from other dishes. Alternatively, 7 encourage patient to use disposable eating utensils.
8 So I think -- I'm sorry. I think Dr. Metter was 9 suggesting that we recommend defining what dedicated 10 means, but I believe the statement that I just read, 11 which is on page 30 of the preliminary draft proposed 12 Reg Guide, kind of clarifies that by saying dedicated 13 to the patient, comma, not shared with other household 14 members.
15 CHAIRMAN PALESTRO: Dr. Metter?
16 VICE CHAIRMAN METTER: Yes, that sounds 17 very appropriate.
18 MEMBER MARTIN: This is Melissa. I would 19 agree with that language also.
20 MS. HOLIDAY: So then it would sound like 21 there is no recommendation to revise the report because 22 the language is adequately captured in the draft 23 proposed Reg Guide.
24 MEMBER MARTIN: Correct.
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33 1 discussion on this point?
2 MEMBER OUHIB: This is Zoubir. Just minor 3 comments. On page 18, regarding the patient 4 instructions, what happens if you have a language 5 barrier? That's item 2.1.
6 MS. HOLIDAY: Oh, you mean page 24 of the 7 draft proposed Reg Guide.
8 MEMBER OUHIB: I guess I'm going from 9 another copy here. Sorry about that.
10 MS. HOLIDAY: You're referencing Section 11 2.1 titled Activities and --
12 MEMBER OUHIB: That is correct.
13 MS. HOLIDAY: -- Requiring Instruction?
14 MEMBER OUHIB: That is correct. If you're 15 dealing with a patient that has a language barrier, 16 you know, where's the provision there? What are we 17 recommending?
18 CHAIRMAN PALESTRO: This is Dr. Palestro.
19 Isn't there a provision in this guidance that suggests, 20 and I can't quote it exactly, but that it's the 21 responsibility of the licensee to determine the 22 individual's ability to follow the instructions?
23 MEMBER OUHIB: But it doesn't give any 24 detail on that. It says it also provides the licensee 25 with the opportunity to determine if the patient will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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34 1 be able to follow the release instruction, but then 2 what? What if the patient cannot follow the 3 instruction? There are no other recommendations after 4 that. Or what are the steps? As a matter of fact, 5 that was one of the items that I had also.
6 MEMBER SHEETZ: This is Mike Sheetz. In 7 Section 2.3.4, patient acknowledgment of instructions, 8 there is a statement there, prior to release of the 9 patient, patient should acknowledge receipt of 10 instructions and the licensee should acknowledge the 11 patient understands the instructions as communicated, 12 so I think it's addressed.
13 MEMBER OUHIB: I'm not sure if that's 14 sufficient.
15 CHAIRMAN PALESTRO: What would you 16 recommend, Zoubir?
17 MEMBER OUHIB: To be honest with you, Dr.
18 Palestro, I haven't thought about it, other than perhaps 19 the licensee should probably take every step possible 20 to ensure that the patient fully understands the 21 instructions, including any language barrier or 22 whatnot, you know, where they use, I don't know, an 23 institution have people that can translate and so on 24 and so forth. I don't know. I don't have the verbiage 25 for that.
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35 1 CHAIRMAN PALESTRO: My own opinion is that 2 it's already amply covered in the guidance, but other 3 opinions?
4 VICE CHAIRMAN METTER: This is Darlene 5 Metter. When we consent patients for therapy, for, 6 let's say, I-131 therapy, and they speak a different 7 language than the person consenting them, we have an 8 official hospital translator and it's documented in 9 the report that all questions were answered through 10 the translator.
11 And the other thing on 2.3.3, it says 12 patient instructions, it says that, you know, the 13 licensee has to comply with 10 CFR 35.75, et cetera, 14 and it says, however, once a patient is released, the 15 licensee has no control of the patient. So, you know, 16 I think you can only do so much. If you ask the patient 17 if they acknowledge, and I believe, I like the idea 18 that the Subcommittee recommended this acknowledgment 19 by the patient and we have a translator and the patient 20 signs it, to me, that's legal documentation that the 21 patient acknowledges that they understand the 22 instructions and the consequences if these are not 23 followed.
24 CHAIRMAN PALESTRO: I'm sorry. Dr.
25 Schleipman.
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36 1 MEMBER SCHLEIPMAN: At our institution, 2 we had numerous translated documents in several 3 languages and brought in official interpreters. Not 4 every institution will have those resources, but I think 5 that the general instructions in the regulatory guide 6 really put the onus on the institution and I think it's 7 sufficiently worded, as well.
8 CHAIRMAN PALESTRO: Zoubir?
9 MEMBER OUHIB: Yes.
10 CHAIRMAN PALESTRO: Does that answer your 11 question? Do you wish to make a motion to revise the 12 report?
13 MEMBER OUHIB: I guess that's probably, 14 to a certain point, convincing maybe. And I would agree 15 with some of the comments that the majority of the 16 institutions have translators and all that, but that's 17 not available at every institution, and that is when 18 there's always a chance of something going wrong.
19 CHAIRMAN PALESTRO: I think we all agree 20 with you, but, again, the onus is on the licensee to 21 make that determination.
22 MEMBER OUHIB: Agree.
23 CHAIRMAN PALESTRO: All right. Thank 24 you. Any other comments, discussion from the ACMUI?
25 MEMBER OUHIB: I do have one on item 2.4, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37 1 death of a patient following radiopharmaceutical 2 administration or implant. Unless I misread it or 3 misunderstood, are we saying somehow that it is okay 4 to cremate under certain conditions?
5 MEMBER SHEETZ: This is Mike Scheetz. No, 6 that's one of the recommendations. I mean, there are 7 precautions and maybe restrictions that need to be 8 taken, but there needs to be some dose-based model 9 created to recommend what activity levels or at what 10 time period after administration of radioactive 11 material implant per patient do the precautions or 12 restrictions need to apply. So, there may be 13 situations where a patient has been administered 14 radioactive material and the recommendation would be 15 not to cremate that body.
16 MEMBER OUHIB: Okay. Are those stated 17 clearly in this here? Because I didn't see that for 18 some reason. I was like wait a minute, aren't we saying 19 something that we're not recommending elsewhere?
20 MEMBER MARTIN: No, I think it's covered 21 -- I'm sorry. This is Melissa. I think it's under 22 other recommendations, number two. It basically says 23 the development of this will be part of the part two 24 revision. It will be a new dose-based model because 25 you can have a patient with a prostate implant that's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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38 1 20 years old. They could very well cremate that patient 2 without a problem. If the patient had a prostate 3 implant last week, then you don't. It all comes down 4 to the dose-based model.
5 MEMBER OUHIB: I hear you. Okay.
6 CHAIRMAN PALESTRO: Does that answer your 7 question, Zoubir?
8 MEMBER OUHIB: Yes. Thank you.
9 CHAIRMAN PALESTRO: Thank you. Any other 10 comments or questions?
11 MEMBER OUHIB: One last item, Dr.
12 Palestro.
13 CHAIRMAN PALESTRO: Yes, sir.
14 MEMBER OUHIB: 3.1, records of release, 15 item number two, for immediate release of a patient 16 based on measured dose rate. I see here we put the 17 result of the measurement, the specific survey 18 instrument. Should we add a calibration information 19 of that survey instrument?
20 MEMBER MARTIN: I think, as long as the 21 institution has got the record of it, that's all you 22 need.
23 MEMBER OUHIB: Well, that applies to the 24 survey instrument also. They have that information, 25 too. But I think I would depict that one of the two, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1 I think the calibration information is more important 2 than the specific survey instrument information.
3 MEMBER GREEN: This is Richard Green. If 4 the operator records the survey instrument that was 5 used to make the survey, then state regulators or NRC 6 regulators or the RSO can go back in and look at the 7 calibration certificate to make sure that that survey 8 instrument used was in calibration and met all the 9 pertinent regulations and requirements. If we don't 10 have that meter used identification, then we can't go 11 any further. So, I think we cover the basis of it.
12 VICE CHAIRMAN METTER: This is Darlene 13 Metter. This is standard language that, I believe, 14 that's in the Reg Guide already.
15 MEMBER MARTIN: This is Melissa. I would 16 agree with that, too. You just want the serial number 17 and model. You can look up the calibration, if needed.
18 CHAIRMAN PALESTRO: Does that answer your 19 concern, Zoubir?
20 MEMBER OUHIB: Somewhat, yes. Thank you.
21 CHAIRMAN PALESTRO: Any other comments, 22 questions, discussion?
23 MEMBER WEIL: This is Laura Weil. I had 24 used the wrong pass code. I apologize. So, I didn't 25 have an open line to get in on the discussion of language NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 proficiency, and I'd like to make a comment about that, 2 if I might at this point.
3 CHAIRMAN PALESTRO: Yes, please.
4 MEMBER WEIL: The provision of 5 instructions regarding post-release precautions for 6 folks who have been administered radiopharmaceuticals 7 is no different from the provision of instructions or 8 information about informed consent or any treatment 9 decision, and you can refer back to the Civil Rights 10 Act of 1964 that language assistance is required for 11 any medical discussions. So I don't think we need to 12 -- I mean, Zoubir, I'm very sensitive and support your 13 concern that there may be situations where language 14 proficiency will be an issue, be it languages other 15 than English or for deaf patients or any number of 16 communication issues, but there's an overriding 17 regulation that requires that language assistance be 18 provided, whether it's a small institution or a large 19 institution, and I'm not sure we need to specify 20 specifically for this particular application that there 21 needs to be interpreters made available or translated 22 documents.
23 CHAIRMAN PALESTRO: Thank you, Ms. Weil.
24 Zoubir, any comments?
25 MEMBER OUHIB: None. Thank you.
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41 1 CHAIRMAN PALESTRO: Any other comments, 2 questions, from the ACMUI? All right. Hearing none, 3 I will now open this session to the public. Is there 4 anyone on the line?
5 OPERATOR: Thank you. We do have a 6 question from Peter Crane. Your line is open.
7 MR. CRANE: Yes, please. Thank you.
8 Appreciate it. In a way, it's a pity that you've waited 9 until the very end to ask for public input because, 10 for example, I had what I thought were some constructive 11 questions on the bylaws and there was no opportunity 12 to raise them. I don't know whether I should do so 13 now. Maybe I should to get them out of the way. Is 14 that all right?
15 CHAIRMAN PALESTRO: That's all right with 16 me. Ms. Holiday?
17 MR. CRANE: Sophie, is that okay by you?
18 MS. HOLIDAY: That's fine.
19 MR. CRANE: Okay. Let me find it quickly.
20 On conflict of interest, Section 4.1, it seems to be 21 a matter of self-reporting sort of in the way that judges 22 of the Supreme Court decide whether to recuse 23 themselves. But suppose it's Member A who thinks 24 Member B shouldn't be taking part in this because of 25 a conflict of interest and Member B doesn't see it that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 way? Because my institutional memory is very long, 2 and I can remember when there was a huge flap about 3 nearly 30 years ago because the Office of General 4 Counsel said that a particular person should be recused 5 from acting on a petition which that individual had 6 filed. And the result was that the general counsel 7 was reported to the Office of Government Ethics with 8 a letter saying who's above the general counsel, God, 9 unquote. So I think that ought to be clarified because, 10 you know, some people are just not sensitive to their 11 own conflicts.
12 Secondly, there is, on page six, item 5.4, 13 where it says the ACMUI should consult with the Office 14 of the General Counsel regarding conflicts that arise 15 from the interpretation of the bylaws. After 16 consultation, the ACMUI shall resolve interpretation 17 issues by a majority vote of the current membership 18 of the ACMUI.
19 Now, what that leaves a little bit open 20 is, suppose the general counsel says you can't do it, 21 does that provision mean that the ACMUI can, by majority 22 vote, disregard it? That's ambiguous, I think. I'm 23 not hearing any response to this. Is this simply a 24 one-way street? Hello?
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43 1 is Dr. Palestro. In response to your first comment, 2 on conflict of interest, that comes directly from legal.
3 That's the standard verbiage that's used, and that's 4 why it was incorporated.
5 MR. CRANE: Okay. But, you know, that may 6 be so, but maybe OGC should be asked what do you do 7 with a situation? That's a situation that has occurred 8 in which the member does not see a conflict that other 9 people do see. I'm not criticizing. I'm just 10 suggesting that this is an item that you might want 11 to think about and consult with the lawyers about.
12 MS. HOUSEMAN: Hi. This is Esther 13 Houseman, attorney in the Office of the General Counsel.
14 I do want to note for everyone on the meeting that 15 the Office of General Counsel does advise the medical 16 team, as well as the ACMUI itself on its obligations 17 as special government employees to abide by the ethics 18 laws that are cited here. The Office of the General 19 Counsel is also available to answer any legal questions 20 concerning those ethics requirements and also any 21 questions the staff have on the ACMUI bylaws. So the 22 ACMUI and the staff do have legal counsel on these 23 matters.
24 MR. CRANE: Well, I understand that, and, 25 actually, I worked in OGC for 23 years, so I'm fairly NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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44 1 familiar with its responsibilities. My point is can 2 OGC, is OGC the deciding word on what's legal or --
3 I'm mixing the two issues -- or can the ACMUI override 4 and act in contradiction to OGC advice? Is it unclear 5 to anybody but me?
6 MS. HOUSEMAN: I think what you're asking 7 right now is a legal question on which OGC would provide 8 legal advice, and I'm not going to provide a legal 9 analysis in the middle of a meeting of this sort. So, 10 I'm not sure what additional information you want.
11 MR. CRANE: Fair enough. All I'm saying 12 is I think this language leaves it a bit open as to 13 whether ACMUI can override OGC, and I think that these 14 sorts of ambiguities ought to be resolved beyond any 15 dispute before and not after they go into effect.
16 That's all I'm saying. Avoiding problems by foreseeing 17 them.
18 MS. HOLIDAY: Thank you for your comment, 19 Mr. Crane. We'll take that under consideration when 20 the ACMUI, they are planning to look at the bylaws later 21 on in the near future, and so this feeds on what they 22 take into consideration on a future date.
23 MR. CRANE: Thank you. If that's Sophie, 24 thanks, because I think I recognize your voice, right?
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45 1 you.
2 MR. CRANE: Okay. Third point on the 3 bylaws, it says that the NRC will -- this is 3.1, NRC 4 will solicit nominations by notice in the Federal 5 Register and by such other means as are approved by 6 the Commission. Evaluation of a candidate shall be 7 by such procedures as are approved by the director of 8 NMSS. It's a little vague as to what that is. It seems 9 to be unlimited discretion to the director of NMSS.
10 Is there any conceivable public interest in keeping 11 confidential the names of people who nominate 12 themselves or are nominated for ACMUI positions? Can 13 anybody think of a reason?
14 CHAIRMAN PALESTRO: I'm sorry, Mr. Crane.
15 This is Dr. Palestro. I don't quite understand.
16 Could you restate your concern?
17 MR. CRANE: Okay. My question is it says 18 procedures to be determined by the director of NMSS.
19 That gives him, seems to give him unlimited discretion 20 to do whatever he wants. And it seems to me that, in 21 an agency that dedicates itself to openness, there ought 22 to be a certain degree of openness as to what those 23 procedures are.
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46 1 wrote to the NRC and the person chosen was the director 2 of isotope production at DOE. I wrote to the NRC and 3 asked who were the other candidates. I was not a 4 candidate, incidentally. And I got back a letter 5 saying we can't tell you and we wouldn't tell you even 6 if you filed a FOIA, Freedom of Information Act request 7 for the benefit of anybody who doesn't know that. And 8 I thought, well, I'll test that out, and I did file 9 a FOIA and I got back, no, this is privileged 10 information. And it seems to me there ought to be an 11 open process. We ought to know who's nominated, by 12 whom, self-nominated, by organizations, by 13 individuals, et cetera, and we ought to know the process 14 by which these decisions are made.
15 MS. HOLIDAY: Hello, Mr. Crane, this is 16 Sophie.
17 MR. CRANE: Yes.
18 MS. HOLIDAY: First, I would like to start 19 off by saying that the scope of this meeting was to 20 discuss the proposed amendment to the bylaws, not 21 necessarily to open up other sections of the bylaws 22 as this is related to the discussion at the ACMUI 23 Subcommittee related to the bylaws presented during 24 the April 2019 meeting. However, I will respond to 25 you regarding the process by which the Director of NMSS NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 selects individuals. Paired with any HR hiring 2 guidance, we do not disclose that type of information 3 in terms of who has applied and who has supported them 4 -- so on and so forth. Similar to how we do not release 5 that type of information for general NRC staff 6 applications, we would not do the same for our special 7 government employees, i.e., the ACMUI members.
8 MR. CRANE: I see. Well, you know, I can 9 -- I can -- I hear what you're saying, certainly, but 10 I have -- and I didn't appreciate that -- that the --
11 the meeting was intended to be limited to very minor 12 changes in the bylaws. It seems to me that when people 13 nominate themselves for a public position, that there 14 is something to be said for greater openness. That 15 it's different from, you know, applying for a job as 16 a -- as a lawyer or a health physicist and having to 17 be listed in the Federal Register as among the rejected 18 candidates. I do think there is a difference. But 19 this isn't the time to debate that.
20 Okay, well that -- that concludes my --
21 what I have to say about the bylaws. But I do have 22 things to say about the patient release issue. If I 23 may continue. May I continue?
24 CHAIRMAN PALESTRO: Please do, sir.
25 MR. CRANE: Thank you, Dr. Palestro.
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48 1 Okay, I am -- there is a consistent problem with the 2 NRC -- to me, with the NRC rule in that it tends to 3 minimize the risk of internal exposure. And that has 4 been true for many years. And just to give the briefest 5 of background, in 1986, the NRC staff turned down a 6 suggestion that release be based on dose to the likely 7 person and it said that in fact this was too uncertain 8 -- that the calculations were easy, but knowing just 9 who was going to be where for how long was complicated.
10 And it said that patients presented a risk both from 11 external and from internal dose. Which I think was 12 entirely correct.
13 And in 1997, when the NRC changed the rules 14 to adopt a dose-based rule, it did so on the basis of 15 advice from a gentleman now deceased -- a nuclear 16 medicine doctor -- who believed that I-131 was no 17 carcinogenic and that the effect of a nuclear accident 18 -- the radiation effect of a nuclear accident would 19 not be harmful on the public's health but rather might 20 be beneficial. And with that kind of attitude, it is 21 understandable that some oddities came into this rule.
22 And one of them was that internal dose was to be 23 ignored, except for the nursing mother. And that 24 everything was to be based on external dose --
25 calculation of probable external dose.
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49 1 And, you know, I think there is no -- my 2 own view is that nothing is going to solve this problem 3 without the NRC someday biting the bullet and 4 undertaking a rule change. Now, in the Subcommittee's 5 report, under Other Recommendations, on the last page 6 it says, quote, in the patient's precautions and 7 instructions section, it should be emphasized that the 8 major source of radiation dose to other individuals 9 will be from external exposure from the patient, 10 Reference 1. The Reference 1 referred to is ICRP 94.
11 Now, what ICR -- this is -- now here is the way the 12 American Thyroid Association characterized the ICRP 13 94 in its comments to the NRC last year. The ICRP has 14 estimated the risks for all cancers in children at 0.1 15 to 0.2 percent from an effective I-131 dose of one 16 millisievert, which is the equivalent of 100 millirem.
17 Risks the children include those from external 18 radiation exposure as well as potential ingestion of 19 contamination from excreted or secreted I-131 from 20 treated patients. The ATA currently recommends that, 21 quote, having a treated parent staying in the home is 22 often problematic due to children's needs to be near 23 the treated parent. Special arrangements should be 24 made for children to stay with relatives or friends.
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50 1 relatives or friends where children or pregnant women 2 are absent.
3 If you go to ICRP 94 it says, the modes 4 of exposure to other people are external exposure, 5 internal exposure due to contamination and 6 environmental pathways. Doses to adults from patients 7 is mainly due to external exposure. Contamination of 8 infants and children with saliva from a patient could 9 result in significant doses for the child's thyroid.
10 It is important to avoid contamination of children 11 or pregnant women. And, I mean it -- why do we -- why 12 does the NRC pay for potassium iodide to be stockpiled 13 around nuclear plants? Why does the government 14 stockpile it against acts of terrorism, if not because 15 there is a risk to the public -- and to children above 16 all -- from internal contamination with I-131? And 17 if we are taught -- if this ICRP estimation quoted by 18 the ATA is correct, that means that the 500 millirems 19 that the NRC allows -- which is five times what the 20 ICRP and NCRP permit -- could mean a dose -- an increase 21 of 1 percent in cancer in the exposed child -- five 22 -- half percent to 1 percent. And I just don't see 23 what the benefit is from this rule that makes that 24 possible. And I don't think that we should have a 25 regulatory guide -- and this is what troubles me about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 the ACMUI comment that seems to minimize the 2 significance of internal dose. There's nothing in 3 there about kissing.
4 The -- on page 11 of the ACMUI comments 5 the following appears. Page 13, Section 2.3.1, add 6 hotel to the list of examples of post-treatment lodging 7 the patient may use. Why is this troubling? Because 8 the word may have two distinct meanings. It could mean 9 either it is possible that a patient will go to a hotel, 10 or patients are permitted to go to a hotel. Now, it 11 wasn't that long ago that the NRC put out a regulatory 12 information summary -- 2011 -- saying that it is 13 strongly discouraged that patients go to hotels. So, 14 unless the NRC has changed its mind and no longer thinks 15 that it's strongly discouraged, this ambiguous comment 16 should not be accepted. On the contrary, the Reg Guide 17 ought to reiterate the warning in the RIS.
18 I would like, also, to respond to the --
19 well, okay, under 10 CFR 35.75, if the licensee cannot 20 find that a patient's exposure to others will be under 21 500 millirems, it cannot release the patient. No ifs, 22 ands or buts. The draft regulatory guide makes this 23 point under Section 2.32, Patient Precautions, but 24 because the entire guide is declared to be non-binding, 25 as in compliance with RGs is not required, the reader NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 may not realize that this is a requirement of the 2 regulation and not a waivable piece of guidance.
3 MR. EINBERG: Dr. Palestro?
4 CHAIRMAN PALESTRO: Yes?
5 MR. EINBERG: Dr. Daibes here would like 6 to make a comment in response to Mr. Crane's comments 7 regarding internal doses.
8 (Simultaneous speaking.)
9 MR. CRANE: By all means.
10 CHAIRMAN PALESTRO: That's fine, thank 11 you.
12 DR. DAIBES: Thank you. Mr. Crane, for 13 the next stage of the update, Phase 2, one component 14 that will be considered is internal contamination and 15 the duration of the contamination. So -- but that's 16 something that we are pursuing and the NRC is very aware 17 of.
18 MR. CRANE: I am very happy to hear that.
19 But then, why, I would ask, is there this comment about 20 stressing that the -- the risk is from external 21 contamination in -- in this stage?
22 (No audible response.)
23 MR. CRANE: I mean ---
24 (Simultaneous speaking.)
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53 1 risks would be from external. However, we are aware 2 that there is a risk from internal and that's why we're 3 ---
4 MR. CRANE: I am sorry, I am sorry -- it's 5 ---
6 (Simultaneous speaking.)
7 MR. CRANE: -- Peter Crane again.
8 C-R-A-N-E. I mean, why, I would ask, does the -- does 9 this phase of the report -- this is -- this line, for 10 example, under Other Recommendations, it should be 11 emphasized that the major source of radiation dose to 12 other individuals will be from external exposure to 13 the patient. But I can give you lots of chapter and 14 verse on the fact of, yes, the greatest dose to adults 15 is going to be from external radiation. But the 16 greatest danger is going to be to children from internal 17 radiation. And we saw it at Chernobyl -- you've got 18 7,000 kids with childhood thyroid cancer. Childhood 19 in the sense that the exposure came in the first four 20 years of life. And it was generally either from 21 inhalation, or from the milk pathway. And I just don't 22 think we should, at any point, be emphasizing one to 23 the exclusion of the other.
24 You look at ICRP 94 and they're very clear 25 that the -- external, the danger to children -- the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 heavy danger to children is from internal. They don't 2 say that it's greater, but they say that it's great.
3 Is that -- am I misstating ICRP 94? Does anybody think 4 I am?
5 (Pause.)
6 MR. EINBERG: So, Dr. Palestro, Chris 7 Einberg here again. I think, in the interest of 8 providing other commenters an opportunity to comment 9 as well, we should focus our comments on phase 1 10 comments. This update to Reg Guide 8.39 focuses on 11 Phase 1. Phase 2, when it gets to, you know, dosimetric 12 cal -- calculations and the methodologies -- but I think 13 for the interest of time, we certainly will be providing 14 the public the opportunity to make comments on Reg Guide 15 8.39 when we publish this later on this summer. And 16 it will go out in the Federal Register for public 17 comment. But at this stage, I think we would like to 18 hear about the phase 1 comments that members of the 19 public have.
20 (Simultaneous speaking.)
21 CHAIRMAN PALESTRO: Thank you, Mr.
22 Einberg.
23 MR. CRANE: Thank you, Chris. I 24 appreciate that. And I don't want to monopolize the 25 phone. So, let me sign off and go back to listening NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 1 mode. And thank you Dr. Palestro and members of the 2 Committee for hearing me out.
3 MR. EINBERG: Thank you, Mr. Crane.
4 CHAIRMAN PALESTRO: Thank you, Mr. Crane.
5 Other comments from the public?
6 OPERATOR: Thank you. Our next comment 7 is from Carol Marcus. Your line is open.
8 DR. MARCUS: Thank you very much. I would 9 like to make comments on Table 3. The specifics of 10 column 3, which is examples of recommended duration 11 of interruption of breastfeeding. At the bottom of 12 Table 3, the NRC notes that the recommendations in 13 column 3 are from the Advisory Committee on Medical 14 Use of Isotopes Nursing Mother Guidelines for the 15 Medical Administration of Radioactive Material. And 16 there were some meetings about that previously.
17 However, of the 18 non-technetium 18 radiopharmaceuticals, nine of them are not what was 19 recommended by the ACMUI Subcommittee.
20 I looked in ICRP 106 to see if the NRC was 21 using that instead, but they are not. And I don't know 22 where some of these numbers come from. For example, 23 for I-131 Hippuran, you know, Pat Zanzonico's 24 calculations -- which are the basis of the Subcommittee 25 report -- recommended -- for 100 millirem dose to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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56 1 infant -- recommended 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of interruption of 2 breastfeeding. ICRP 106 recommended 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> of 3 interruption. But NRC recommends complete cessation 4 of breastfeeding for this infant or child. And I don't 5 know where in the world that comes from. Again, for 6 thallium-201 chloride, Zanzonico's calculation is for 7 the 100 millirem dose is interruption for 4.3 days.
8 ICRP 106 has an interruption of 2 days. NRC lists an 9 interruption of 14 days. And I don't know where that 10 comes from. If fluorine-18 labeled -- it doesn't say 11 labeled what -- but let's call it FDG, the ICRP 106 12 recommends no interruption. Zanzonico recommends 4 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> of interruption for 100 millirem, and no 14 interruption for 500 millirem, which is the regulatory 15 limit. But the NRC document lists 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> for 100 16 millirem. I don't know where that comes from.
17 And then there are six more that are not 18 in compliance with the calculations in the Subcommittee 19 report. So, my first problem with this table is that 20 it says it comes from the Subcommittee report, but it 21 doesn't. Other comments --
22 CHAIRMAN PALESTRO: Dr. Marcus?
23 DR. MARCUS: Yes?
24 CHAIRMAN PALESTRO: Dr. Marcus, I am sorry 25 to interrupt you. This is Dr. Palestro. Regarding NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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57 1 your comment on Table -- your comments on Table 3, the 2 way this evolved is that the working group and the 3 subcommittee were not exactly in temporal synch on Table 4 3. And that recommendations of the subcommittee will 5 in fact be incorporated in Table 3 when it goes out 6 for public comment. Mr. Einberg, correct me if I am 7 wrong on that?
8 MR. EINBERG: No, that is correct. Thank 9 you for that clarification.
10 CHAIRMAN PALESTRO: Thank you. All 11 right, go ahead, Dr. Marcus.
12 DR. MARCUS: Yes, okay, thank you, Chris.
13 So -- so I should ignore column 3 because it is going 14 to be changed? Is that it?
15 CHAIRMAN PALESTRO: That is correct.
16 There are changes that are going to be made and the 17 time to review it is when Phase 1 is out for public 18 comment.
19 DR. MARCUS: Okay. While you are doing 20 things like that, there is no such isotope as 21 gallium-55. So please fix that. Maybe they mean 22 gallium-68. But it just listed gallium-55 labeled, 23 and then not even what it is attached to. And -- and 24 this --
25 CHAIRMAN PALESTRO: So noted.
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58 1 DR. MARCUS: Okay, as I recall in the last 2 ACMUI meeting when Pat Zanzonico was still on the 3 Committee it was agreed, I think unanimously, by the 4 ACMUI that we should have recommendations for the 500 5 millirem limit, because that's what the regulatory 6 limit is. And then there was some argument about 7 conservatism with 100 millirem. And then it was 8 decided we should have both. But in this document, 9 there is no mention of any of the 500 millirem 10 calculations and recommendations. However, you know, 11 the subcommittee report contains all of the 500 millirem 12 recommendations. And I think that the 500 millirem 13 recommendations belong in this guidance because that's 14 the regulatory limit. There are a lot of conservatism 15 in the calculation of radiation dose to the nursing 16 child. And putting another 500 percent on it like this 17 is not called for. So, I think we should put in the 18 500 millirem recommendation of the ACMUI Subcommittee 19 into this document. As far as --
20 MS. HOLIDAY: Dr. Marcus? Dr. Marcus, 21 this is Sophie.
22 DR. MARCUS: Hello.
23 MS. HOLIDAY: Hello. So, if I could just 24 add on to what Dr. Palestro and Mr. Einberg already 25 stated, you know, it was highlighted at the bottom of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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59 1 page 2 -- going over to page 3 -- of the Subcommittee's 2 report that the table should be updated to reflect the 3 recommendations in the ACMUI January 31st, 2019 4 Subcommittee report. And if you look at the draft 5 proposed Reg Guide that is attached to this document, 6 Reference 6 is where it is referencing the subcommittee 7 report that was used. And it states there that from 8 the 2018 subcommittee report -- so by virtue of that 9 -- I am raising that point to just simply say that the 10 tables will be updated as appropriate when it goes out 11 for public comment later on this summer. So, realize 12 that it does not reflect the cessation periods or the 13 500 millirem -- or any of that information that is 14 contained in the January 2019 Subcommittee report.
15 But that's because that's not what was used when this 16 document was routed to the ACMUI for its review.
17 DR. MARCUS: But Sophie, are you going to 18 include 500 millirem values?
19 MS. HOLIDAY: I am not a part of that 20 working group, so I can't speak on that. I am simply 21 stating the fact that the ACMUI's report from January 22 of this year will be referenced when the reg guide goes 23 out for public comment. So I -- again, I can't speak 24 whether or not the 500 millirem will be used or not.
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60 1 -- which was endorsed unanimously by the Committee --
2 will be used by the working group as it considers the 3 ACMUI's comments during this meeting, as well as any 4 other comments that they may have received internally 5 before it goes out for public comment.
6 DR. MARCUS: Okay. Well, I encourage the 7 ACMUI to recommend to the NRC that the 500 millirem 8 values be included in this document. I really don't 9 want to start a big discussion on what Peter Crane is 10 saying. We could go on forever. We have already gone 11 on for about 25 years. But when you talk about saliva 12 being a source of internal contamination to babies and 13 young children, you know, I think if adults are French 14 kissing babies and young children, there is a lot bigger 15 problem around than radiation. I think this is really 16 overly exaggerated.
17 But, the authorized users take into 18 consideration if there are babies and young children 19 around -- and I don't see that there is any problem 20 with any of it. You know, Peter doesn't have any data 21 showing some incredible increase in thyroid cancer in 22 children whose family members were treated for thyroid 23 cancer. You know -- unless it's a genetic basis. And 24 then it isn't from I-131, it's just from a genetic 25 mutation. So I don't think that this saliva issue is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 a really meaningful one.
2 As far as cremating bodies, you can have 3 a service for someone who has died, and you can hold 4 the corpse in the morgue for a month, or weeks, or 5 whatever you need. And you can incinerate it 6 subsequently. There's certainly very safe ways of 7 doing these things. And I don't think that this has 8 led to any bad problems, either. You can have some 9 contamination, but that doesn't mean it's a public 10 health and safety hazard. It doesn't mean that the 11 radiation dose is dangerous. Just a few atoms around 12 doesn't really make it dangerous at all -- which is 13 why the NRC never made it illegal to put mildly 14 radio-contaminated patient waste in a garbage dump.
15 It's the people who regulate garbage dumps that tried 16 to keep it out. And finally they're getting used to 17 the idea that these tiny levels are harmless and not 18 of any concern, and they're letting it go. It's taken 19 them about 30, 40 years, but they're finally getting 20 there.
21 Okay, I think that's the end of my comments.
22 Thank you, Dr. Palestro.
23 CHAIRMAN PALESTRO: Thank you, Dr. Marcus.
24 Any other comments from the public?
25 OPERATOR: We do have one more comment.
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62 1 Ralph Lieto, your line is open.
2 MR. LIETO: Yes, can you hear me?
3 CHAIRMAN PALESTRO: Yes.
4 MR. LIETO: I have two questions. One is, 5 could staff or --
6 CHAIRMAN PALESTRO: I am sorry, could you 7 please -- hello? Please state your name?
8 MR. LIETO: This is Ralph Lieto. I am a 9 medical physicist. And I have two questions. One 10 relates to the reg guide and its relationship to 11 Appendix U of NUREG-1556, Volume 9. Is it going to 12 replace the Appendix U in its entirety? Or is there 13 going to be some kind of a coordination between the 14 two that's going to have to be done in the future?
15 MS. DIMMICK: This is Lisa Dimmick, 16 Medical Radiation Safety Team Leader. So Reg Guide 17 8.39 will replace Appendix U so that there is only 18 information -- will be in one location. So that we 19 don't have a situation where we have the guidance in 20 two different locations that could potentially be not 21 in synch with the other.
22 MR. LIETO: Very good, excellent, thank 23 you. My last question has to do with when this reg 24 guide goes out for public comment. Will that be after 25 Phase 2? Or is it going to go out after Phase 1, get NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 comments, and then go back out again after Phase 2?
2 MS. DIMMICK: So this is Lisa Dimmick 3 again. So the plan is to publish Phase 1 for public 4 comment this summer. And the plan is to issue Phase 5 1 -- the Phase 1 revision by next April. And while 6 this is happening, in the background we will begin the 7 Phase 2 update with a contractor. And then, once the 8 Phase 2 update is ready for public comment, we will 9 post -- we will publish Reg Guide Phase 2 Update for 10 public comments as well.
11 MR. LIETO: Just for clarification, then, 12 the Phase 2 will go out after you've received all the 13 comments from Phase 1, correct?
14 MS. DIMMICK: And actually probably after 15 we've published a Phase 1 revision. Correct.
16 MR. LIETO: All right, thank you.
17 CHAIRMAN PALESTRO: Any other comments or 18 questions from the public?
19 OPERATOR: At this time we have no 20 questions from the public.
21 CHAIRMAN PALESTRO: Any other comments or 22 questions from ACMUI?
23 (No audible response.)
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64 1 Ms. Jamerson, Ms. Dimmick or Mr. Einberg?
2 MR. EINBERG: Nothing here. This is Chris 3 Einberg.
4 CHAIRMAN PALESTRO: At this point, then, 5 I believe we can adjourn the meeting.
6 MS. HOLIDAY: No, Dr. Palestro.
7 (Laughter.)
8 CHAIRMAN PALESTRO: Yes?
9 MS. HOLIDAY: Is there a motion to approve 10 the Subcommittee's report and its recommendations 11 herein?
12 CHAIRMAN PALESTRO: I'm sorry.
13 MEMBER WOLKOV: So moved. This is Harvey 14 Wolkov.
15 CHAIRMAN PALESTRO: Do I hear a second?
16 MEMBER MARTIN: This is Melissa Martin, 17 I will second.
18 CHAIRMAN PALESTRO: All right, any further 19 discussion?
20 (No audible response.)
21 CHAIRMAN PALESTRO: All in favor?
22 (Chorus of aye.)
23 CHAIRMAN PALESTRO: Any opposed?
24 (No audible response.)
25 CHAIRMAN PALESTRO: Any abstentions?
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65 1 (No audible response.)
2 CHAIRMAN PALESTRO: All right, motion is 3 passed unanimously. Now, Ms. Holiday, can we adjourn 4 the meeting?
5 MS. HOLIDAY: Almost.
6 (Laughter.)
7 MS. HOLIDAY: A very quick summary, since 8 we couldn't hear Ms. Weil earlier, I just need to get 9 on the record whether or not she endorsed the ACMUI 10 Bylaw amendments?
11 (Pause.)
12 MS. HOLIDAY: Ms. Weil?
13 MEMBER WEIL: Yes, I did.
14 MS. HOLIDAY: Thank you. Okay, then for 15 the record we have that the ACMUI passed a motion where 16 Dr. Wolkov made the motion, Dr. Metter seconded to 17 approve the amended bylaws. This was passed with one 18 abstention by Dr. Palestro. The second motion was to 19 approve the ACMUI draft subcommittee report for the 20 Draft Proposed Reg Guide 8.39 Revision 1, Phase 1.
21 The motion was made by Dr. Harvey Wolkov, seconded by 22 Ms. Melissa Martin. This was unanimously endorsed by 23 the committee. Are there any questions, comments, 24 concerns? Or did I misstate the facts?
25 (No audible response.)
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66 1 MS. HOLIDAY: Hearing none, I will capture 2 that and hold to the recommendations from the committee 3 for this meeting.
4 CHAIRMAN PALESTRO: All right, thank you.
5 Any other discussion? Any other matters of business 6 that need to be addressed?
7 MS. JAMERSON: I have one other thing.
8 This is Kellee Jamerson, Dr. Palestro.
9 CHAIRMAN PALESTRO: Yes.
10 MS. JAMERSON: I would like to announce 11 that the fall meeting of the ACMUI will be September 12 10th and 11th, 2019.
13 CHAIRMAN PALESTRO: Thank you. And as I 14 had remembered emailing you about this, just to confirm 15 that it is in fact the second choice, but for reasons 16 of scheduling, that is now the definitive meeting date.
17 Am I correct?
18 MS. JAMERSON: That is correct.
19 CHAIRMAN PALESTRO: All right. Any other 20 business?
21 MR. EINBERG: Yes, and this is Chris 22 Einberg. And I just wanted to thank the subcommittee 23 and the full committee on behalf of the NRC for their 24 hard work on this topic. I know you have put a lot 25 of effort into this and that it's a topic that has a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 lot of interest -- public interest -- and I would like 2 to thank the public commenters, also, for their interest 3 and their comments. And you will have additional 4 opportunities to provide input on this topic. So, 5 thank you everybody.
6 CHAIRMAN PALESTRO: Any other business?
7 Any other comments?
8 (Pause.)
9 MR. EINBERG: Nothing here at the NRC.
10 CHAIRMAN PALESTRO: All right. Anything 11 from the ACMUI?
12 (No audible response.)
13 CHAIRMAN PALESTRO: All right, then --
14 meeting is adjourned. Thank you.
15 (Whereupon, the above-entitled matter went 16 off the record at 3:32 p.m.)
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ef!j> CAROLS. MARCUS, Ph.D., M.D.
MAILING A DDRESS: 1877 COM STOC K AVENUE PHON E: (3 10) 277-4541 LOS ANGELES, CA 90025-50 14 FAX: (3 10) 552-0028 E-MAIL: csmarc us@uc la .edu May 30, 2019 Christopher J. Palestro, M.D.
Zucker School of Medicine at Hofstra/Northwell 13 1 Grotke Road Spring Valley, NY 10977 Re: Comments pertaining to draft of NRC Regulatory Guide 8.39
Dear Dr. Palestro:
I have grave concerns about this draft Regulatory Guide (RG) 8.39. I ask that you forward my comments to your committee, at least the subcommittee studying this, and I ask to speak at the June 10, 2019 meeting.
This document fails to repair the mistakes in its predecessor regulatory guide, NUREG-1556 Appendix U. Despite several telephone calls and e-mails and a few letters requesting correction of erroneous material in Appendix U and its predecessor versions, no corrections have ever been made. Finally, in frustration, I, Jeffry Siegel, and Michael Stabin published a paper in Health Physics delineating the errors (this paper did not address the errors in the breastfeeding portion of this RG). The reference is Siegel JS, Marcus CS, and Stabin MG: Licensee over-reliance on conservatisms in NRC guidance regarding the release of patients treated with 1-131. Health Phys 93(6):667-677, 2007, and a copy is included with this e-mail. I urge you to read it carefully. Copies were sent to the NRC after publication, but still no corrections were made.
The Health Physics paper addresses the four most flagrant apparently purposeful misrepresentations in the RG. They are (1) assumption of the patient as a point source, with no reduction of exposure to others based upon patient self-absorption, (2) a non-void period for the first 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> after 1-131 N al administration, (3) a presumption of an occupancy factor of 0. 75 for the non-void period, and (4) a presumption of internal contamination of 10-5 . Assumption ( 1) introduces an overestimate of about 100%,
because there are high quality data measuring patient self-absorption. Assumption (2) is ludicrous, as patients are well hydrated before I-131 Nal administration and strongly encouraged to consume copious amounts of fluids. This assumption erroneously raises the calculated exposure to others, as the renal half-time for clearance of the non-thyroidal fraction is about 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />. The patients urinate very shortly after 1-131 Nal administration and frequently thereafter. Assumption (3) is a completely unsubstantiated NRC-comments to ACMUI for draft RG 8.36 05-30-19.docx
2 misrepresentation of the occupancy factor and introduces an exposure overestimate of 300%. There is no reason to change the occupancy factor from 0.25 to 0.75. Assumption (4) ignores all the literature and introduces an exposure overestimate of 1000%. All the literature finds that 1o- 6 is an appropriate factor. The present draft RG repairs none of these misrepresentations and also fails to cite literature references which are important and may be found in the Health Physics paper. The NRC appears to be hugely and purposefully overestimating absorbed dose to others in order to dissuade licensees from using the 500 mrem patient discharge rule. There were NRC staff members who fought this rule change for nearly seven years until it was accepted. They still haven't given up.
The draft RG cautions against releasing patients when there are pregnant women or young children at home. This is inappropriate. The radiation limit of 500 millirem is so low that young children and pregnant women may safely receiye it. In fact, NRC's limit to the fetus of a declared pregnant woman is 500 mrem, which NRC considers to be safe.
The rule does not state this, and neither should this draft RG.
The draft RG amazingly does not reference the Radiation Absorbed Dose Assessment Resource (RADAR) web site, with its excellent tutorial on how to perform these dose calculations and an online exposure calculator for individual patients. The site is free and this past year received 66,000 hits. Unlike this draft RG, RADAR is scientifically solid and uses reliable data for its calculations. Competent nuclear medicine professionals are voting with their mice. They want RADAR, not NRC junk.
The information about breastfeeding patients was always misleading. The original calculations were "take out" calculations using the highest values for breast milk uptake, milk intake, and infant thyroid uptake. No infant ever received these doses, but the idea was that if the administered activity of the radiopharmaceutical in question was less than that which was in the table, it was impossible for the infant to get I 00 mrem and no dose calculation needed to be carried out by the licensee. The explanation of the original calculation was in a footnote to the table but was taken out many years ago by Donna-Beth Howe to "save space". What this means is that these are not actual dose calculations but are overestimates by at least 1000%. New calculations were recently performed by Pat Zanzonico, who was formerly on the ACMUI, and were given to the NRC. Dr. Zanzonico' s calculations were for infant doses of 100 mrem and 500 mrem.
What happened to them? They were supposed to be in this draft RG. In addition, the old RG had calculations for suggested interruption of breast feeding, and often had multiple suggested times for single radiopharmaceuticals based upon administered activity. The lower times for lower administered activities were removed from this draft RG. In addition, this RG only addresses doses of I 00 mrem, not the regulatory limit of 500 mrem. They are therefore overestimated by 500 %. So, these values in the RG are at least 1500 % overestimates.
The writer of this document opines that she/he is only being "conservative". That is not true. She/he is committing purposeful lying fraud.
NRC-comments to ACMUI for draft RG 8.36 05-30-19.docx
3 In Table 3, NRC lists "Ga-67 and Zr-80 labeled" and doesn't finish the drug. It also lists "C-11, N-13, 0-15, Rb-82 labeled" and doesn't finish the drugs. It lists "F-18 labeled" and does not list the drugs. It lists "Lu-177 diagnostic" but Lu-1 77 labeled compounds are all therapeutic. It lists "Ra-223 and all alpha emitters" and recommends complete cessation of breastfeeding for that infant but there are no calculations and that doesn't make sense. Do the calculation and justify the RBE. Infants are exposed to alpha emitters at least from birth when they are exposed to Rn-222. It doesn't seem to hurt them. Anyway, Ra-223 dichloride is only approved for the treatment of castration-resistant prostate cancer with no known metastases other than bone. It is ridiculously expensive and insurance companies will only reimburse for the FDA approved indication.
It is therefore not used off-label, and men don' t breast-feed. NRC lists "Ga-55 labeled" but doesn't finish the drug and there is no such radionuclide as Ga-55. Under "Notes" the NRC is behind the times. It certainly does regulate accelerator-produced radioactive material and changed the definition of "byproduct material" to include it. This same erroneous message is in "Notes" in Table 2.
There are many examples of added paperwork requirements that are not in the actual rule and that were not in previous versions of this mess. This is completely inappropriate.
All in all, I find this draft RG, and its predecessors, to be without scientific value and to be grossly dishonest and suggest that the ACMUI recommends that they be trashed. We do not need any NRC "guidance". The NRC only needs to suggest that licensees use RADAR instead.
Thank you for your attention and consideration.
Sincerely, Carol S. Marcus, Ph.D., M.D.
Prof. of Molecular and Medical Pharmacology (Nuclear Medicine) and of Radiation Oncology. Prof. of Radiological Sciences, ret.
David Geffen School of Medicine at UCLA NRC-comments to ACMUI for draft RG 8.36 05-30-19.docx
Paper--------------
LICENSEE OVER-RELIANCE ON CONSERVATISMS IN NRC GUIDANCE REGARDING THE RELEASE OF PATIENTS TREATED WITH 1311 Jeffry A. Siegel,* Carol S. Marcus/ and Michael G. Stabin+
other individuals exposed to the patient (U.S . NRC Abstract-Medical licensees are required to comply with U.S. 1997). The dose-based limit, which replaced the activity-Nuclear Regulatory Commission (NRC) regulations pertaining to the release of patients administered radioactive material. or dose-rate-based release limit, < 1,110 MBq (30 mCi)
However, use of the associated NRC guidance expressed in or < 0.05 mSv h- 1 (5 mrem h- 1) at 1 min 1997, better NUREG-1556, Volume 9, is completely optional and has been expresses the NRC' s primary concern for the public' s shown to be overly conservative. Rigid adherence to the health and safety and makes good scientific sense. A guidance recommendations has placed an undue burden on nuclear medicine therapy patients and their families, as well as licensee may release patients, regardless of administered licensees responsible for ensuring compliance with NRC re- activity, if it can be demonstrated that the total effective quirements. More realistic guidance has been published by dose equivalent (TEDE) to another individual from other responsible professional societies and will be presented exposure to a released patient is not likely to exceed 5 in this work. These more realistic calculations allow for higher releasable activity levels than the widely adopted NUREG mSv (0.5 rem).
levels, particularly for thyroid cancer patients. The guidance- Individuals exposed to released radionuclide therapy suggested releasable activity limit is similar to our calcula- patients can potentially receive radiation doses by two tional result for hyperthyroid patients, 2.1 GBq (57 mCi) distinct sources: external exposure and internal intake.
compared to 2.3 GBq (62 mCi), but is significantly lower for thyroid cancer patients, 6.6 GBq (179 mCi) vs. 16.9 GBq (457 The TEDE concept makes it possible to combine these mCi) using the regulatory definition of the total effective dose dose components in assessing the overall risk to the equivalent (TEDE). Higher limits are both possible and rea- health of an individual. The TEDE, pursuant to 10 CFR sonable, if the permissible extra-regulatory definition of the 20.1003, is equal to the sum of the deep-dose equivalent TEDE is used in which the effective dose equivalent (EDE),
rather than the deep-dose equivalent (DDE), is determined. (DDE), due to external exposure, and the committed We maintain that professionals evaluating compliance with the effective dose equivalent (CEDE), due to internal intake.
NRC requirements for patient release, pursuant to 10 CFR Thus, TEDE = DDE + CEDE.
35.75, should use the procedures presented here and not rely U.S. NRC regulations, pursuant to 10 CFR 20.1101 ,
automatically on the NUREG.
Health Phys. 93(6):667-677; 2007 require that applicants and licensees develop, document, Key words: nuclear medicine; dosimetry; safety standards; and implement operating policies and procedures as part medical radiation of an overall radiation protection program that will ensure compliance and the security and safe use of licensed materials. These radiation protection policies INTRODUCTION and procedures for their implementation are neither detailed in the regulations nor required to be submitted as U.S. N ucLEAR Regulatory Commission (NRC) regula-part of the license application (Siegel 2004 ). Some tions for the release of patients administered radioactive practitioners have developed their own radiation protec-material, pursuant to 10 CFR 35.75, authorize patient tion programs, but most have relied on model procedures release according to a dose-based limit, i.e. , the dose to published by the NRC in guidance documents. There is
- Nuclear Physics Enterprises, Marlton, NJ; 1 UCLA, Los Angeles, no question that licensees must comply with NRC CA; t Vanderbilt University, Nashvi lle, TN. regulations, but doing so by adopting regulatory guid-For correspondence contact: Michael G. Stabin, Department of ance is not necessary. The NRC will accept alternative Radiology and Radiological Sciences, Vanderbilt University, 1161 21 st Avenue South, Nashville, TN 37232-2675, or email at michael.g.stabin @ approaches, but a large number of licensees know that vanderbilt.edu. use and adoption of NRC-proposed guidance will clearly (Manuscript accepted 4 May 2007 )
0017-9078/07 /0 provide an acceptable approach to the NRC and many Copyright © 2007 Health Physics Society licensees are not able to devote the time or resources 667
668 Health Physics December 2007, Volume 93 , Number 6 necessary to establish their own alternative implementing Use of the "default" values. The "default" patient procedures and policies. Although guidance documents release values are based on integration of external dose to do not contain regulatory requirements, if licensees a maximally exposed individual to total decay after commit to following these procedures they will become release of patients receiving radioactive material. Two conditions of their licenses. very conservative assumptions are involved in modeling We do not take issue here with the NRC regulations this dose in NUREG-1556, Vol. 9: 1) that the activity in related to patient release. We do, however, note that the the patient can be represented as an unshielded point associated NRC guidance for licensee compliance with source; and 2) that removal of activity from the patient is 10 CFR 35.75 as promulgated in NUREG-1556, Vol. 9, only due to physical decay of the radionuclide involved.
Rev.I, Appendix U, Model Procedure for Release of This approach fails to consider the distributed nature of Patients or Human Research Subjects Administered Ra- most radiopharmaceutical agents and does not account dioactive Materials, has been shown to be overly con- for the often significant biological elimination that di-servative and places a high burden on nuclear medicine minishes activity levels in the patient (and thus dose rates therapy patients and their families , as well as on licensees outside the patient) over time. This method is highly who adopt the guidance. A series of published studies over-conservative for 13 11 sodium iodide. Therapy pa-and guidelines issued by other responsible professional tients receiving 13 11 do not retain 100% of the radioac-societies has provided guidance in compliance with the tivity for the physical half-life of the radionuclide (8 d);
applicable NRC requirements at a clearly lower burden rather, a significant portion of the administered activity is to all parties involved. Substitution of these approaches not taken up by the thyroid gland and is rapidly excreted.
for those in the NUREG will provide a clear benefit to For 1311, the 5 mSv dose limit is predicted in the NUREG patients and their families , and will make the job of to be achieved with an administered activity of 1,221 licensees easier as well. We will confine our arguments MBq (33 mCi), or a dose rate of 0.07 mSv h- 1 (7 mrem to the release of patients who have received oral Na 131 1 h - i) at 1 m, for both thyroid cancer and hyperthyroid for the treatment of thyroid cancer or hyperthyroidism, patients, representing a value of 4.10 X 10- 3 mSv MBq - 1 but note that the rationale of the arguments applies also (15.2 mrem mCi - 1) (this dose per unit administered to other radionuclide therapy agents. activity is an order of magnitude higher than if a The purpose of this work is to critically evaluate the patient-specific dose calculation is performed; compare compliance-implementing procedures as proposed in the to values given below based on eqn 1). In essence, use of NUREG and to suggest alternative compliance methods. NRC "default values" for Na 1311 represents a return to the We examine the guidance methods to assess the external historical "30-mCi rule" and is quite regressive, espe-dose component, the internal dose component, and thus cially since there is no credible origin or scientific basis the TEDE, and by so doing, demonstrate that the guid- for this rule (Siegel 2000). Further, empirical data re-ance procedures are overly conservative and introduce an cently obtained by measurement of the dose received by unnecessary regulatory burden not codified in NRC family members of thyroid cancer patients receiving 1311 requirements. We propose alternative procedures to en- (Grigsby et al. 2000) support and confirm that the use of able licensee compliance with 10 CFR 35.75, and we a 1,221 MBq activity limit for all patients is overly recommend that all licensees use these procedures in- conservative.
stead of automatic reliance on the NRC guidance docu- Clearly, use of only simple knowledge of adminis-ments. tered activity, without consideration of such things as radionuclide clearance from the body and the patient's lifestyle, require issuance of patient instructions to main-PATIENT RELEASE BASED ON NRC tain doses to others that are as low as is reasonably GUIDANCE achievable (ALARA) that would have to be in place for The external dose component (DDE) an extremely long time. Rational analysis suggests that NUREG-1556, Vol. 9, Rev.I , Appendix U (U.S. the use of overly simplistic "point-source-radioactive-NRC 2005) provides model procedures for calculating decay-only" models will significantly overestimate doses the external dose to others from exposure to released to others from Na 131I (and many other radiopharmaceu-patients. According to the NUREG, compliance with the ticals) , and thi s has been confirmed by actual measure-NRC regulatory dose limit requirement can be demon- ments (Grigsby et al. 2000). Thus, there is no question strated by licensees by either: (1) using provided default that -patient-specific dose calculations that would permit tables for activity or dose rate at I m for a variety of the release of patients from radioactive isolation with radionuclides; or (2) performing a patient-specific dose more than 1,221 MBq must be performed for 1311 therapy calculation. patients to provide a more complete and appropriate
Release of patients treated with 13 1 1 e J. A . SIEGEL ET AL. 669 estimation of dose (and patient release instructions) to for the external dose component per unit administered individuals likely to be exposed to the patient. activity, Q0
- In the case of thyroid cancer patients:
Use of the patient-specific dose calculation. The
- DDE(co)/Q0 (mSv MBq - 1) = 2.06 X 10- 3 {0.135 +
"patient-specific" dose equation provided in the NUREG 0.0739 + 0.0887} = 6.12 X 10- 4 mSv MBq - 1; and that can be used to estimate the likely external exposure
- DDE(co)/Q0 (mrem mCi- 1) = 7.61 {0.135 + 0.0739 +
to total decay, i.e., DDE at infinite time or DDE(co) in 0.0887} = 2.27 mrem mci - 1, mSv (mrem), to an individual from a released radionu-clide therapy patient receiving oral Na 131I for thyroid where the percentages of the total dose due to the cancer and hyperthyroidism is: non-void, extrathyroidal, and thyroidal components are 45%, 25%, and 30%, respectively.
DDE(co) = [34.6fQ 0]/(100 cm) 2 {£ 1Tp(0.8)
In the case of hyperthyroid patients:
[) _ e - 0.693(TNv)/Tp] + e - 0.693(TNv)/Tp E2F I T1 eff
- DDE( 00 )/Q0 (mSv MBq - 1) = 2.06 X 10- 3 {0.135 +
0.0739 + 0.0887) = 2.39 X 10-3 mSv MBq - 1; and
- DDE(co)/Q0 (mrem mCi - 1) = 7.61 {0.135 + 0.0156 +
where: 1.01} = 8.84 mrem mCi - 1, 34.6 = conversion factor of 24 h d- 1 times total integration of decay (1.44 ); where the percentages of the total dose due to the r = exposure rate constant for an unshielded non-void, extrathyroidal, and thyroidal components are point source, for 131 1 = 0.595 mSv cm 2 12 %, 1%, and 87%, respectively.
MBq- 1 h- 1 (2,200 mR cm 2 mCi- 1 h- 1); These 2 equations can be solved for the maximum Q0 = administered activity in MBq (mCi); allowable administered activities for authorizing patient
£ 1 = occupancy factor for first 8-h non-void pe- release based on the 5 mSv regulatory dose limit. Eqn (I) riod = 0.75; can also be solved for the maximum allowable dose rates TP = physical half-life in days = 8.04 for 131 1; at 1 m, given by fQJ(] 00 emf These values are shown 0.8 = an assumed factor indicating that 80% of the in Table 1.
administered activity is removed from the These activity limits, as well as those in later body only by the physical half-life of 131 1 sections, can be applied to all patient releases. According during the non-void period; to the NUREG, the parameter values in eqn ( 1) are TNv = non-void period in days = 0.33 (8 h) ; "acceptable" values (e.g., the occupancy factors and the
£ 2 = occupancy factor from 8 h to total decay = representative uptake fractions and effective half-lives) 0.25; to be used in class-specific dose calculations for patients F 1 = extrathyroidal uptake fraction = 0.20 in hy- with thyroid cancer and hyperthyroidism. Thus, individ-perthyroid patients = 0.95 in thyroid cancer ual dose calculations need not be performed on a case-patients; by-case basis for these patients, unless a specific pa-T1err = effective half-life of extrathyroidal compo- tient's situation warrants the use of parameter values nent = 0.32 d in hyperthyroid patients = different from those used in eqn ( 1). For example, the 0.32 d in thyroid cancer patients; licensee may select more realistic uptake fraction and F 2 = thyroidal uptake fraction = 0.80 in hyperthy- effective half-life values from the scientific literature or roid patients = 0.05 in thyroid cancer pa- choose to measure the biokinetics in individual patients, tients; and measure the dose rate and/or use an occupancy factor T2err = effective half-life of thyroidal component = <0.25, if appropriate. In these cases, as stated in the 5.2 d in hyperthyroid patients = 7.3 d in NUREG, a patient-specific calculation would be required thyroid cancer patients.
Eqn (I) represents the dose to an individual likely to Table 1. Maximum activities and dose rates at l m for authorizing receive the highest dose from exposure to released 1311 patient release for thyroid cancer and hyperthyroid patients (based patients as it is taken to be the dose to total decay. The on eqn 1).
equation contains 3 components: (I) a non-void period Acti vity in GBq Dose rate in mSv h- 1 (mCi ) (mrem h" 1) for the first 8 h after administration; (2) an extrathyroidal component from 8 h to total decay; and (3) a thyroidal Thyroid cancer 8.2 (221) 0.49 (49)
Hyperthyroidism 2. 1 (57) 0.12 (12) component from 8 h to total decay. Eqn ( 1) can be solved
670 Health Physics December 2007 , Volume 93, Number 6 in place of the use of the class-specific values given in Report No. 5 (Berman et al. 1975) for the case of a Table 1. maximum thyroid uptake of 5% in euthyroid patients. It This class-specific approach is highly conservative should be noted that mean whole-body residence times and unnecessarily restrictive. Several assumptions were have been observed to be longer for hypothyroid (24.1 h) made by the NRC in assigning values to the parameters than euthyroid (17 .3 h) patients (Hanscheid et al. 2006).
used in eqn (I). The two biggest contributors to the Thus, established models and recent data indicate that conservatism are: I) use of the exposure rate constant, approximately 50% of the administered activity is ex-which is an unshielded point source value; and 2) use of creted from the body during the NRC's presumed non-an 8-h non-void period and associated 0.75 occupancy void period in the case of a thyroid cancer patient.
factor. Since a patient is not adequately represented as an The inclusion of the non-void component in eqn (I) unshielded point source (particularly with respect to their has a profound effect on the estimated dose an individual extrathyroidal activity distribution), an exposure rate is likely to receive, particularly from released thyroid constant accounting for radionuclide distribution and cancer patients. As demonstrated above, 45 % of the total patient attenuation must be used since without such dose is attributable to the non-void component for these considerations unrealistic and unnecessarily conservative patients (Siegel 1999); thus, its inclusion represents an results will be obtained, perhaps as high as a factor of 2 additional factor of 2 conservatism as the 8.2 GBq (Sparks et al. 1998; Siegel et al. 2002a). activity limit in Table I is likely to result in a dose of During the first 8 h after administration, 80% of the only 2.75 mSv, equal to 3.35 X 10- 4 mSv MBq- 1 (1.24 131 1 administered is assumed to be removed from the rnrem mCi - 1). In support of this claim, a regulatory body at a rate determined only by its physical half-life to analysis on the revised IO CFR 35.75 completed in 1996 account for the time of the 1311 to be absorbed from the (Schneider and McGuire 1996) made no mention of an stomach to the blood and the holdup of iodine in initial non-void period and estimated, for example, that the urine while in the bladder. The remaining 20% of the based on use of only a two-component model consisting administered activity must be associated with some of thyroidal and extrathyroidal biokinetics, the maximum unknown physiological mechanism as it is unaccounted likely dose to total decay to individuals exposed to a for during this initial 8-h non-void period. It is important thyroid cancer patient would be 2.48 mSv from a 7.4 to note that there are no scientific data to support the GBq activity administration, equal to 3.35 X 10- 4 mSv notion of a "non-void" period of any significant length. MBq- 1 (1.24 mrem mCi - 1). For hyperthyroid patients, Patients are hydrated before the administration of Na 1311 inclusion of the non-void component has minimal effect and are strongly urged to drink plenty of fluids for several (as demonstrated above, the percent of the total calcu-days afterwards. Patients often void before even leaving the lated dose attributable to this initial non-void period is Nuclear Medicine service, and frequently thereafter. Na 1311 12%) and is really not necessary as it is mathematically is absorbed within I0-15 min after an oral administration redundant; approximately 14% of the administered ac-(Loevinger et al. 1988) and upon reaching the blood is tivity is excreted from the body at 8 h based on the immediately filtered out by the kidneys; with large fluid NUREG representative uptake fractions and effective intakes, the patient may typically void hourly. half-lives.
A recent international controlled study of iodine Direct measurements are the best way to obtain the biokinetics in radioiodine therapy of thyroid cancer dose any individual is likely to receive based on the reality (Hanscheid et al. 2006) indicated that the whole body of daily life. Dosimeter measurements obtained in 65 retention of radioiodine was generally described by a household members of 30 patients who received outpatient 131 biexponential activity-time curve, with no significant 1 therapy for thyroid carcinoma indicated that the mea-activity excretion time delay, based on whole-body sured radiation dose was on average a factor of IO lower probe and gamma camera scanning measurements. The than the radiation dose predicted based on eqn (I) (Grigsby total body residence times obtained (mean value of et al. 2000). These empirical data are further evidence 24.1 h in hypothyroid patients) were in good agreement demonstrating the overly conservative nature of the dose with the value of 23.2 h, a value that would be calculated calculation as implemented through use of eqn (I).
based on the NRC guidance representative values for a 2-component total body retention curve involving extra- The internal dose component (CEDE) thyroidal and thyroidal components. In addition , this NRC guidance in NUREG-1556, Vol. 9, Rev.l, latter total body residence time of 23.2 h with an Appendix U uses the following equation for the likely associated activity excretion of 48 % at 8 h, correspond- internal dose component (i.e., CEDE) for individuals ing to generally . hypothyroid patients, is in excellent who may come in contact with a released patient who agreement with that reported in MIRD Dose Estimate received oral Na 13 11:
131 Release of patients treated with 1
- CEDE (Sv) = Q 0 (MBq) X 10- 5 X 1.43 X 10- 2 "highly exposed" individual has ever been found , and no documentation substantiates that this "factor of IO" Sv MBq- 1; and conservative approach is advisable, necessary, or accu-rate.
,
(2)
The total effective dose equivalent (TEDE) where I 0- 5 is the NRC assumed fractional intake and Summing the values of DDE(oo) per unit administered 1.43 X w- 2 Sv MBq - 1 (53 rem mCi - 1) is the dose activity, based on the patient-specific dose calculation given conversion factor to convert an intake of 131I in MBq by eqn (1) and the CEDE per unit administered activity (mCi) to a CEDE in Sv (rem). It is obvious from this values based on eqn (2), the TEDE per unit administered equation that the predicted internal dose component per activity is given as follows.
unit activity will always be a constant value of 1.43 X In the case of thyroid cancer patients:
J0- 4 mSv MBq - 1 (0.53 mrem mCi - 1) . Thus, unlike the
- TEDEJQ0 (mSv MBq- 1) = 6.12 X 10- 4 mSv MBq- 1 +
guidance for the external dose component, which permits 1.43 X I0- 4 mSv MBq- 1; and variability and thus patient-specificity, only a fixed or
- TEDE/Q0 (mrem mCi - 1) = 2.27 mrem mCi - 1 + 0.53 case-specific internal dose component is considered for mrem mCi - 1*
both thyroid cancer and hyperthyroid patients.
A common "rule of thumb" is to assume that no In the case of hyperthyroid patients:
more than I millionth of the activity being handled will become an intake to an individual working with the
- TEDEJQ0 (mSv MBq- 1) = 2.39 X 10- 3 mSv MBq- 1 +
material. This heuristic was developed for cases of 1.43 X I0- 4 mSv MBq- 1; and worker intakes during normal workplace operations,
- TEDE/Q0 (mrem mCi - 1) = 8.84 mrem mCi - 1 + 0.53 worker intakes from accidental exposures, and public mrem mCi - 1*
intakes from accidental airborne releases from a facility Using this approach, the internal dose component will (Brodsky 1980), but it does not specifically apply for always be 23% (l.43/6.12) and 6% (1.43/23.9) of the cases of intake by an individual exposed to a patient. external dose component for thyroid cancer and hyper-Admittedly, there are limited data for thyroid uptakes in thyroid patients, respectively, irrespective of the admin-family members exposed to Na 131I patients. Two studies istered activity.
performed in the 1970' s (Buchan and Brindle 1970; NRC guidance states that when the internal dose Jacobson et al. 1978) on the intakes of individuals component is less than 10% of the external component, it exposed to patients administered 131I indicated that in- does not need to be considered (U.S. NRC 2005). Thus, takes were generally on the order of I millionth of the internal contamination will never have to be considered activity administered to the patient and that internal for hyperthyroid patients whereas the summation of doses were far below external doses. Based on these two internal and external dose components will always be studies, NUREG-1492 (Schneider and McGuire 1996), required for thyroid cancer patients if a patient-specific the regulatory analysis for JO CFR 35.75, concluded that dose calculation is performed. In the case of the NUREG internal doses are likely to be much smaller than external default-value approach, the TEDE is assumed to be equal doses and much smaller than the public dose limit, and to the external dose "because the dose from intake by therefore did not consider internal exposures in their other individuals is expected to be small." The values in analyses. In addition, the National Council on Radiation Table 1 are therefore valid for the release of hyperthyroid Protection and Measurements (NCRP) addressed the risk patients, e.g. , the maximum releasable activity is 2.1 of intake of radionuclides from patients' secretions and GBq. However, the Table 1 values cannot be used for excreta in NCRP Commentary No. 11 , Dose Limits for thyroid cancer patients, e.g. , the maximum releasable Individuals Who Receive Exposure from Radionuclide activity of 8.2 GBq is not applicable. The dose calcula-Therapy Patients and concluded that "a contamination tion approach will always result in a maximum releasable incident that could lead to a significant intake of radio- activity for thyroid cancer patients of 6.6 GBq (179 mCi) active material is very unlikely." (the constraint that the CEDE is always 23 % of the As given in eqn (2), NRC guidance recommends use DDE(oo), which forces a DDE of approximately 4.05 of 1o-s for the assumed fractional intake. According to mSv and an associated CEDE of 0.95 mSv to be in NRC, this value was chosen in order to account for the compliance with the 5 mSv TEDE limit). Although not most highly exposed individual and to add a degree of applicable, if the same logic is followed, but thi s time conservatism to the calculation. However, no such with the constraint that the CEDE always be 6% of the
672 Health Physics December 2007, Volume 93 , Number 6 DDE(oo), the maximum releasable activity for hyperthy- radionuclide therapy patients and their families. Impor-roid patients would be 2.0 GBq (53 mCi). tantly, the regulations, pursuant to 10 CFR 35.75(a), do The advice requiring inclusion/exclusion of the not require any calculational conservatism, let alone that internal dose component in the NUREG for the TEDE promulgated in the NUREG; licensees must only dem-calculation has no basis in regulatory requirements; in onstrate that the TEDE to any other individual from fact, it adds an "extra-regulatory" burden on licensees. It exposure to a released patient is not likely to exceed 5 is also incorrect as it may violate NRC regulations. For mSv. Maintaining this calculated dose to others ALARA example, Example 4 in the NUREG uses the "default" is the purpose of the required instructions, pursuant to 10 value external dose of 5 mSv for a 1,221 MBq 1311 CFR 35 .75(b). In point of fact, a patient receiving 1,221 administration and determines a CEDE of* 0.17 mSv. MBq of 1311 for hyperthyroidism can potentially expose Since the internal dose is only 3% of the external dose, it individuals to a larger radiation dose than a patient is stated that the CEDE determinations are never neces- receiving 7.4 GBq of 1311 for thyroid cancer if appropriate sary in the TEDE calculation if the default-value ap- instructions are not provided, due to the much longer proach is taken; however, the TEDE will . exceed the retention of a significant fraction of 131 1 in the body in the regulatory limit of 5 mSv (5 mSv + 0.17 mSv = 5.17 former case.
mSv) and the licensee would be in violation of NRC Therefore, we recommend that licensees perform regulations. more realistic calculations (e.g., use of an appropriate The maximum activity release values given in this shielding factor for the exposure rate constant, no non-section are based on the assumption that the "patient- void period, use of a fractional intake value of I o-6 ) and specific" dose calculation approach (use of eqns 1 and 2) not simply automatically adhere to the approaches pro-used for determination of the TEDE is accurate. As vided in the NUREG in order to permit realistic release described above, the NUREG approach is, at the very limits and patient instructions that still are clearly in least, unjustifiably conservative, potentially by a factor compliance with NRC regulations.
as high as 4 in the case of thyroid cancer patients. The conservatism is due mainly to the assumption of an PATIENT RELEASE BASED ON SNM/ACNP essentially non-existent non-void period, the use of an GUIDANCE exposure rate constant representing an unshielded point One alternative approach to that given in NRC source for the extrathyroidal activity biodistribution, and guidance that can be used for patient release has been the use of an intake value of 10- 5* The more appropriate proposed in a Society of Nuclear Medicine and American maximum fractional intake value of 1o-6 should be used College of Nuclear Physicians (SNM/ACNP) guidebook since this level is seldom, if ever, exceeded by the (Siegel 2004). Using eqn (1), but substituting an expo-reported data. This "seldom exceeded" criterion was used sure rate constant equal to 0.459 mSv cm 2 MBq - 1 h- 1 in the NUREG in Footnote I of Table U.6 for selection (1 ,700 mR cm 2 mCi - 1 h- 1) (Carey et al. 1995), a of the thyroid uptake fraction in the hyperthyroidism non-void period of I h, and an occupancy factor of 0.25 case. The impact of these assumptions in the case of during this period, the maximum allowable activities and hyperthyroid patient release is much less significant dose rates for authorizing patient release are given in since we have shown that the majority of the calculated Table 2.
total dose to others (i.e., 87%) is due to the thyroidal In our opinion, licensees can quite justifiably use the component.
values in Table 2 as their basis for patient release. The When data are not available, use of conservative maximum activity and dose rate values are higher in calculations may be reasonable, as they can identify or Table 2 than in Table 1 due to the use of less conservative rule out a potential problem and may be used to add a and more realistic parameter values. It should be noted margin of safety to procedures that do not have well-that this method assumes that the TEDE is equal to the defined outcomes. However, when data are available, as external dose. This is because the internal dose was they are in the case of patients treated with Na 13 1I for thyroid cancer and hyperthyroidism, the overuse of conservatism does not serve the goal of radiation protec- Table 2. Maximum acti vities and dose rates at I m for authori zing tion practice, which is to provide optimization of radia- patient release for thyroid cancer and hyperthyroid patients (based tion doses (economic, social, and other factors consid- on SNM/ACNP guidebook).
ered) within a system of dose limitation. Massive Activity in GBq Dose rate in mS v h- 1 (mCi) (mrem h- 1) conservatism violates the principle of optimization and places an undue burden on those enforcing dose limits Thyroid cancer 18.2 (493) 0.84 (84)
Hyperthyroidism 3.0 (80) 0.14 (14) and on those subject to the limitations; in this case,
131 Release of patients treated with 1
- J. A. SIEGEL ET AL. 673 considered to be negligible due to the use of an intake better approach would be to neglect the "10% of the factor of 10- 6
- This is certainly a preferred approach to external dose" NUREG guidance as discussed above and that given in the NUREG as it results in more realistic include the internal dose component in the calculation. The activity and dose rate release limits. maximum activities for authorizing patient release are then 16.9 GBq (457 mCi) and 2.3 GBq (62 mCi) for thyroid PATIENT RELEASE BASED ON cancer and hyperthyroid patients, respectively, based on the METHODOLOGY DESCRIBED IN THIS WORK TEDE.
These activity limits are still conservative as they We recommend that the patient-specific dose calcu- are based on the use of the DDE for the TEDE, which lation be performed as follows : does not account for attenuation and scatter within the TEDE = DDE(oo) + CEDE, exposed individual (pursuant to IO CFR 20.1003, the DDE is the dose equivalent at a tissue depth of I cm), and where: therefore only approximates the likely surface entrance DDE(oo) = [34.6 fQ 0 ]/(l 00 cm) 2 dose to the exposed individual (Sparks et al. 1998). In situations where doses are calculated rather than mea-sured, we recommend that licensees use the EDE in place and of the DDE in the TEDE determination, and according to an NRC Regulatory Issue Summary (U.S. NRC 2003) no CEDE = Q 0 (MBq) X I o- 6 prior NRC approval is required. The EDE has been reported to be a factor of 0.6, on average, less than the X 1.43 X 10- 2 Sv MBq- 1* (2a)
DDE for 13 11 (Sparks et al. I 998). Using this permissible Eqn (I a) includes only 2 components representing the extra-regulatory definition of the TEDE (i.e., TEDE =
thyroidal and nonthyroidal biokinetic components (the EDE + CEDE), the maximum activities for authorizing non-void period has been eliminated), the factor 0.6 patient release are 27.2 GBq (739 mCi) and 3.8 GBq (103 represents a more accurate correction to the exposure rate mCi) for thyroid cancer and hyperthyroid patients, respec-constant given in eqn (I) (Siegel et al. 2002a) for the tively. The administered dosages for these patients will extrathyroidal component (the exposure rate constant is virtually always be less than these activity limits, indicating appropriately applicable only to activity confined to the that all patients are immediately releasable based on patient-thyroid gland), and F and Tcff are the same as those used specific calculations according to NRC regulations.
in eqn (I) for thyroid cancer and hyperthyroid patients. NRC regulations pursuant to IO CFR 35.75(b) also Note that eqn (2a) recommends use of an intake factor require that released individuals be provided with instruc-equal to I o-6
- tions on actions recommended to maintain doses to others Upon rearrangement and summation of eqns (la) ALARA. Pursuant to 10 CFR Part 20.1003, ALARA means and (2a), the TEDE per unit administered activity is as making every reasonable effort to maintain exposures to follows. radiation as far below the dose Limits as is practical. NRC In the case of thyroid cancer patients: has stated that "dose" in this context means the TEDE.
Internal and external doses are not minimized separately,
- TEDE/Q0 (mSv MBq - 1) = 2.82 X 10- 4 mSv MBq - 1 and ALARA efforts should be directed at minimizing their
+ 1.43 X 10- 5 mSv MBq - 1; and sum, the TEDE. Since the internal dose is such a small
- TEDE/Q0 (mrem mCi- 1) = 1.04 mrem mCi - 1 + 0.053 fraction of the external dose, the TEDE can be most mrem mCi - 1*
effectively minimized by efforts to minimize the external In the case of hyperthyroid patients: dose component through adequate patient instructions. A three step approach is necessary (Siegel et al. 2002a):
- TEDEJQ0 (mSv MBq- 1) = 2.16 X 10- 3 mSv MBq- 1 +
1.43 X 10- 5 mSv MBq- 1; and 1. An evaluation of individual's living and working
- TEDE/Q0 (mrem mCi - 1) = 7.99 mrem mCi- 1 + 0.053 conditions must be performed to ascertain whether or mrem mci- 1* not the patient can be safely released; In both cases the internal dose component does not have 2. An appropriate patient-specific dose calculation to be taken into account, as it will always be less than should be performed to ensure that no individual will I 0% of the external dose component. The maximum likely be exposed to a dose in excess of 5 mSv; and activities for authorizing patient release are I 7. 7 GBq 3. Written, not just oral, instructions that are simple and (481 mCi) and 2.3 GBq (63 mCi) for thyroid cancer and clear must be provided so that the patient can limit the hyperthyroid patients, respectively, based on the DDE. A radiation dose to others to as low as reasonably
674 Health Physics December 2007, Volu me 93, Number 6 achievable. The Authorized User (AU) physician times necessary for the relevant instructions to remain in must be satisfied that patient compliance with these effect should differ for these two groups of patients.
instructions is highly likely. Finally, it is important to note that radioactive articles in the household trash of patients are sometimes appearing Each of these three steps is equally important. Just at solid waste landfills that have installed radiation because patients are releasable based on the patient-monitors to prevent the entry of any detectable radioac-specific dose calculation does not mean that these pa-tivity. Even though the radioactivity levels potentially tients should necessarily be released. For example, it is contained in any household waste of patients released in important to know if infants, young children, or pregnant accordance with IO CFR 35 .75 pose an insignificant women reside in the released patient' s home (or are hazard to the public health and safety or to the environ-likely to come in contact with the patient) in order to ment, professionals can take steps to avoid issues with conclude that the patient should be released and/or in landfill owners and operators and even individual states order to provide meaningful instructions to minimize (Siegel and Sparks 2002). It is probably wise to instruct exposure to these individuals, which in the professional patients to avoid or minimize use of items that cannot be opinion of the AU physician will be comprehended by disposed of via*plumbing (toilet, sink, dishwasher, wash-the patient and likely complied with. Any licensee ing machine), such as plastic utensils and paper plates releasing patients without giving due consideration to the (Siegel 2004).
three steps above should be considered to be not in compliance with IO CFR 35 .75 [licensees must also maintain a record of the basis for authorizing patient
SUMMARY
OF MAXIMUM RELEASABLE release pursuant to 10 CFR 35.75(c)]. Clearly, regula- ACTIVITIES tions will not prevent all unintended exposures. The Table 3 summarizes the maximum releasable activ-underlying premise of NRC regulations is that AU ities for both hyperthyroid and thyroid cancer patients physicians will understand radiation safety principles and presented in this work.
practices and will make appropriate decisions. Licensees All values in Table 3 were determined based on an have certain responsibilities and need to implement occupancy factor of 0.25 for the extrathyroidal and policies and procedures to ensure adequate and effective thyroidal components. If a licensee determines that a radiation safety practices. lower occupancy factor (e.g., 0.125) is justified for a The NUREG is of limited value in providing appro- particular patient, then even higher activities would be priate and adequate patient instructions. As a good calculated.
example, the suggested durations of the instructions provided for the occupancy factor selection in Section THE LICENSEE'S ROLE IN PATIENT RELEASE B.1 .2 do not differentiate between thyroid cancer and hyperthyroid patients. As demonstrated by our analyses More realistic calculations allow for even higher of eqn (1 ), 30% of the total dose is attributable to the time releasable activity levels, particularly for thyroid cancer period from 8 h post-administration to total decay in the patients. The guidance approach involving patient-case of thyroid cancer patients, while 87% of the total specific dose calculations results in a releasable activity dose is delivered over this same time period for hyper- limit similar to our calculational approach for hyperthy-thyroid patients. It seems appropriate, therefore, that the roid patients (2.1 GBq vs. 2.3 GBq) , but the activity limit Table 3. Summary of maximum releasable activities.
Acti vity in GBq (mCi )
Method (TEDE definiti on) Hyperthyroidism Thyroid cancer I. NUREG
- 3. Thi s work
' NA = not applicable .
131 Release of patients treated with 1
- J. A. SIEGEL ET AL. 675 for thyroid cancer patients is significantly lower (6.6 on volume and fractional uptake of iodine, could exceed GBq vs. 16.9 GBq) using the regulatory definition of the this activity limit (lagaru and McDougall 2007). It is TEDE. The similarity in the hyperthyroid case is due to important to note that RSOs are not required to blindly the fact that the majority of the estimated dose to others accept and adopt optional NRC guidance, but they are is due to the thyroidal component and the overly conser- required to release radioactive patients in a manner that vative assumptions made in guidance have minimal complies with 10 CFR 35 .75 and, therefore, must be effect. If a licensee chooses to replace the DDE with the proficient in determining the likely dose to others from EDE, then the release limits are even higher (27.2 GBq exposure to such released patients. We have shown that and 3.8 GBq for thyroid cancer and hyperthyroid pa- less conservative activity levels can achieve these goals.
tients, respectively) and now significantly different even RSOs generally are not able to devote the time or for hyperthyroid patients. Thus, it is reasonable to ask the resources necessary to perform complex modeling cal-question, "Why have licensees broadly adopted the culations to verify the adequacy of NUREG recommen-NUREG guidance for patient release?" dations. Thus, it is common practice for licensees to Given that regulatory requirements for patient re- simply adopt NRC guidance documents without critical lease have historically been unrealistically conservative assessment of their strengths and weaknesses. Uniform and that the current NUREG guidance procedures are adoption of a single standard across the profession also still overly conservative, particularly with regard to facilitates the work of NRC inspectors. We have dem-thyroid cancer patients, it is difficult to justify providing onstrated, however, that a more scientifically sound but such information to nuclear medicine physicians to still easily implementable approach, i.e., one not requir-determine patient release limits. Perhaps many licensees ing patient-specific biokinetic studies and dose calcula-have adopted these procedures because most of their tions, can achieve the same goals as use of the NUREG ,
clinical treatments involving Na 131 I can be managed and lessen the burden on licensees, patients, and others.
under the guidance release limits of either: 1) 1,221 MBq based on the default-value approach; or 2) 2.1 GBq and CONCLUSION 6.6 GBq using the patient-specific calculational dose approach for hyperthyroid and thyroid cancer patient Licensees must comply with NRC regulations but treatments, respectively. Rarely, they might argue, is are under no obligation to adopt NRC guidance. Pres-there a need for hyperthyroid treatments involving ently, there appears to be a considerable degree of
> 1,221 MBq or thyroid cancer treatments with > 6.6 confusion as to what is required by the regulations and GBq and, therefore, the higher activity release limits in what is optional, i.e. , guidance. Rigid adherence to the our recommended approaches may not be required. The guidance recommendations has placed an undue burden important point is that, quite distinct from medical on nuclear medicine therapy patients and their families, judgments by physicians in deciding what activity pre- as well as licensees responsible for ensuring compliance scription is best suited for their patients, the activity with NRC requirements. We have shown that guidance-release limits we have determined here from a radiation suggested releasable activity limits are similar to those safety perspective pose little or no adverse impact on the we have calculated for hyperthyroid patients, 2.1 GBq public health and safety. Many institutions are providing (57 mCi) vs. 2.3 GBq (62 mCi) , but are much lower for thyroid cancer treatments based on a dosimetric ap- thyroid cancer patients, 6.6 GBq (179 mCi) vs. 16.9 GBq proach, rather than an empiric fixed activity, generally (457 mCi) using the regulatory definition of the TEDE.
involving an activity prescription > 7.4 GBq, and these Higher limits are both possible and reasonable, if the institutions need not be subjected to an unnecessary permissible extra-regulatory definition of the TEDE is "tie-down" license condition preventing them from re- used in which the EDE, rather than the DDE, is deter-leasing their patients with activities greater than 6.6 GBq. mined. We maintain that professionals evaluating com-If more realistic activity limits, as presented and pliance with 10 CFR 35 .75 should use the approaches discussed in this work, were given to physicians by their presented here to comply with NRC requirements. These Radiation Safety Officers (RSOs), higher activity admin- approaches are easily implementable by licensees, as istrations might be more routine. For example, treating they do not require patient-specific biokinetic studies and autonomous hyperfunctioning nodules with empiric dose calculations.
fixed dosages of 1311 that have been determined solely on A repeat of the quiescence with which NRC' s the basis of the quantity of activity that would not require "30-mCi rule" was accepted by those in the radiation hospitalization (currently believed by many to be 1,221 safety community is not justified. As chronicled by MBq) is a common practice. However, for large nodular Siegel (2000), this activity limit, lacking scientific justi-thyroid glands, administered dosages, if calculated based fication or evidence demonstrating it would actually
676 Health Physics December 2007, Volume 93, Number 6 present a hazard to the public health and safety, was REFERENCES responsible for inappropriately low treatme_nt activities, Barrington SF, O' Doherty MJ, Kettle AG, Thomson WH, unnecessary patient hospitalizations and increased health Mountford PJ, Burrell DN , Farrell RJ , Batchelor S, Seed P, care costs for over 50 y. Harding LK. Radiation exposure of the families of outpa-Use of the 1,221 MBq activity (or 0.07 mSv h- 1 at tients treated with radioiodine (iodine-131) for hyperthy-I m dose rate) patient release limit based on the NRC roidism. Eur J Nucl Med 26:686-692; 1999.
Berman M, Braverman LE, Burke J, Groot LD, McCormack KR, guidance "default" approach should never be employed Oddie TH, Rohrer RH, Weliman HN, Smith EM. MlRD Dose by any licensee permitted to release patients pursuant to Estimate Report No. 5: Summary of current radiation dose JO CFR 35.75. These values indicate lower limits for estimates to humans from 1231, 1241, 125 1, 1261, 13°.I, 1311, and 1321 as which NRC does not believe it necessary to perform sodium iodide. J Nucl Med 16:857-860; 1975.
Brodsky A. Resuspension factors and probabilities of intake of patient specific calculations to demonstrate that others material in process (Or "Is I0- 6 a magic number in health potentially exposed to a released patient will not likely physics?"). Health Phys 39:992- IOOO; 1980.
receive a radiation dose that exceeds 5 mSv. However, Buchan RCT, Brindle JM. Radioiodine therapy to outpa-the assumptions made by the NRC in arriving at these tients- the contamination hazard . Br J Radiol 43:479 - 482; 1970.
guidance values are inaccurate and unjustifiably conser- Carey JE, Kumpuris TM, Wrobel MC. Release of patients vative. Even if a licensee were to follow the patient- containing therapeutic dosages of iodine- 13 I from hospi -
specific dose calculational approach provided for in tals. J Nucl Med Technol 23:144-149; 1995.
NRC's NUREG guidance document, thyroid cancer and Grigsby PW, Siegel BA, Baker S, Eichling JO. Radiation exposure from outpatient radioactive iodine [13 11] therapy hyperthyroid patients receiving greater than 6.6 GBq and for thyroid carcinoma. JAMA 283:2272-2274; 2000.
2.1 GBq, respectively, would always have to be hospi- Hanscheid H, Lassmann M, Luster M, Thomas SR, Pacini F, talized. There is also no scientific basis or justification Ceccarelli C, Ladenson PW, Wahl RL, Schlumberger M, for these so-called "forced activity level" confinements. Ricard M, Driedger A, Kloos RT, Sherman SI, Haugen BR, Carriere V, Corone C, Reiners C. Iodine biokinetics and The NUREG patient release methodology also intro- dosimetry in radioiodine therapy of thyroid cancer: proce-duces a regulatory burden not as yet codified in NRC dures and results of a prospective international controlled requirements. Indeed, patients, particularly thyroid can- study of ablation after rhTSH or hormone withdrawal.
J Nucl Med 47:648 - 654; 2006.
cer patients, can be released in accordance with NRC Iagaru A, McDougall IR. Treatment of thyrotoxicosis. J Nucl regulations with much higher activities, as demonstrated Med 48 :379 -3 89; 2007.
in this work, without adversely impacting on the public Jacobson AP, Plato PA, Toeroek D. Contamination of the health and safety. home environment by patients treated with iodine-131:
initial results. Am J Public Health 68:230 - 235 ; 1978.
Patients and their families share the largest burden Loevinger R, Budinger TF, Watson EE. MIRD primer for when overly restrictive release criteria are enforced. absorbed dose calculations. New York: The Society of Alternative guidance for patient release by stakeholder Nuclear Medicine; 1988.
professional organizations is available for use (Siegel Mathieu I, Caussin J, Smeesters P, Wambersie A, Beckers C.
Recommended restrictions after 1311 therapy: measured 2004). Licensees may adopt and implement the approach doses in family members. Health Phys 76:129 - 136; 1999.
presented here, or they could develop their own appro- Schneider S, McGuire SA. Regulatory analysis on criteria for priate approach given that a wealth of scientific literature the release of patients administered radioactive material.
now exists (Siegel et al. 2002b; Mathieu et al. 1999; Washington, DC: U.S . Nuclear Regulatory Commi ssion ;
NUREG-1492 (Final Report); 1996.
Barrington et al. 1999; Zanzonico et al. 2000; Venencia Siegel JA. Outpatient radionuclide therapy. In: Radiation et al. 2002; Siegel et al. 2002a). Possible consequences of protection in medicine: contemporary issues. Proceedings overly rigid adherence to the NUREG procedures include of the Thirty-Fifth Annual Meeting of the National Council the under-treatment of patients, issuance of overly restric- on Radiation Protection and Measurements. Washington, DC: NCRP; Proceedings No. 21; 1999: 187- 199.
tive release instructions, and unnecessary confinement of Siegel JA. Tracking the origin of the NRC 30-mCi rule. J Nucl patients to hospital beds. The significant and unjustified Med 41: I0N- l 6N; 2000.
additional cost to patients and their loved ones, the require- Siegel JA. Nuclear Regulatory Commission regulation of ment for hospitals to prepare and decontaminate unneeded nuclear medicine: Guide for diagnostic nuclear medicine and radiopharmaceutical therapy. Reston, VA : Society of rooms so that staff can receive unnecessary radiation expo-Nuclear Medicine; 2004.
sures, and the adoption of substandard patient release Siegel JA, Sparks RB . Radioactivity appearing at landfills in policies associated with licensee adherence to NRC patient- household trash of nuclear medicine patients: much ado release guidance should be critically re-evaluated given the about nothing? Health Phys. 82:367-372; 2002 .
guidance presented in this work. These procedures are in Siegel JA, Kroll S, Regan D, Kaminski MS , Wahl RL. A practical methodology for patient release after Tositu-compliance with NRC requirements and their use can lessen momab and 1311-Tositumomab therapy . J Nucl Med 43:354 -
the burden on licensees. 363; 2002a.
131 Release of patients treated with 1
- J. A. SIEGEL ET AL. 677 Siegel JA, Marcus CS, Sparks RB. Calculating the absorbed dose U.S. Nuclear Regulatory Commission. Model procedure for to others from the radioactive patient: line source model versus release of patients or human research subjects administered point source model. J Nucl Med 43: 1241-1244; 2002b. radioactive materials. Washington, DC: U.S . Nuclear Reg-Sparks RB, Siegel JA, Wahl RL. The need for better methods ulatory Commission; NUREG-1556, Vol. 9, Rev . I, Appen-to determine release criteria for patients administered radio- dix U; 2005.
active material. Health Phys 75 :385- 388; 1998. Yenencia CD, Germanier AG, Bustos SR, Giovannini AA, U.S. Nuclear Regulatory Commission. Criteria for the release Wyse EP. Hospital discharge of patients with thyroid of individuals administered radioactive material. Washing- carcinoma treated with 131 1. J Nucl Med 43:61-65; 2002.
ton, DC: U.S. Nuclear Regulatory Commission; 10 CFR Zanzonico PB, Siegel JA, Germain JS . A generalized algorithm Parts 20 and 35: 62 FR 4120; 1997. for determining the time of release and the duration of U.S . Nuclear Regulatory Commission. Use of the EDE in place post-release radiation precautions following radionuclide of the DDE in dose assessments. Washington, DC: U.S . therapy. Health Phys 78:648 - 659; 2000.
Nuclear Regulatory Commission; NRC Regulatory Issue Summary 2003-04; 2003.
June 1, 2019 From: Michael G. Stabin, PhD, CHP Chair, RAdiation Dose Assessment Resource (RADAR) Committee of the Society of Nuclear Medicine and Molecular Imaging 3809 W 48th Ave Kennewick, WA 99337 To: Christopher J. Palestro, M.D.
Zucker School of Medicine at Hofstra/Northwell 131 Grotke Road Spring Valley, NY 10977 Re: Comments on new draft ofNRC Regulatory Guide 8.39
Dear Dr. Palestro:
I am writing to express my concerns regarding the new draft NRC Regulatory Guide 8.39. I am profoundly disappointed that the scientific basis of this proposed RG contains the same scientific errors as related predecessor documents, errors that have been extensively and repeatedly refuted in the published scientific literature over many years. Your charter states that the committee:
" ... provides advice, as requested by the Director, Division of Material Safety, State, Tribal, and Rulemaking Programs (MSTR), Office of Nuclear Material Safety and Safeguards (NMSS), on policy and technical issues that arise in regulating the medical use of byproduct material for diagnosis and therapy."
This advice SHOULD be based on the best scientific data currently available, or the advice is not of value. Members of the RADAR Committee have been perhaps the most active in deliberating this issue publicly, but we are certainly not the only ones. The broad consensus of the scientific community is that the science presented in previous versions of this RG, and now amazingly presented again, are in error. I will mention the specific errors that SHOULD be corrected, and provide the extensive literature basis for doing so.
The principal equation proposed for patient release, based on the completely antiquated ( 1970)
NCRP Report No. 37, is:
(Equation 1)
WhereD(t) = Accumulated exposure at time t, in roentgens, 34.6 = Conversion factor of 24 hrs/day times the total integration of decay (1 .44),
r = Specific gamma ray constant for a point source, R/mCi-hr at 1 cm, Qo = Initial activity of the point source in millicuries, at the time of the release, Tp = Physical half-life indays r =Distance from the point source to the point of interest in centimeters, t = Exposure time in days.
The fallacies in this equation are:
- 1) The assumption that the patient is a point source, with no absorption of emitted radiation by the patient's body,
- 2) The use of a non-void period for the first 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> after 1-131 Nal administration,
- 3) The presumption of an occupancy factor of 0.75 for the non-void period, and
- 4) The presumption of internal contamination of 10-5 .
- In 2002, Siegel et al. made actual measurements of patients whose bodies contained 1-131 Tositumomab and found that "measured dose rates were 60% (range, 37%-90%; P
<0.0001) of the theoretic dose rates from a point source in air. . . "
- In 2011 , Willegaignon et al. monitored 90 subjects with thermoluminescent detectors after release after treatment of thyroid cancer with 1-131 and found significantly lower cumulative doses than predicted by the RG equation.
- In 2007, RADAR members Siegel, Marcus, and Stabin rationally critiqued all of the RG assumptions in the Health Physics Journal article "Licensee Over-Reliance on Conservatisms in NRC Guidance Regarding the Release of Patients Treated with 131 1.
Health Phys. 93(6):667- 677; 2007." It pointed out flaws in all four of the above assumptions, and showed that the correct equation to use is:
- 0 . 693 X 00 J 34 . 6 x o.2s x A x r 1, 2 x r ( 1 e T1 12 D ( Cf) )
2
( } 00 C111 )
[) ( X) ) s .66 x 1 o -4 A x r1 12 x r
... WITH use of the self-absorption factor of 0.6 for activity in the extrathyroidal component ofl-131 retention. The treatment of a patient as an unshielded point source ( for any radionuclide) is a completely unrealistic assumption, and hampers licensees ' ability to release patients who will be absolutely of no hazard to anyone. All of this, with worked examples, and a FREE patient release calculator for many radionuclides, is well documented on the RADAR web site at http://www.doseinfo-radar.com/ExposureCalculator.html. This calculational tool is used heavily, on a daily basis, by people around the USA and the world.
It completely baffles me, as well as other members of the RADAR Committee and the scientific community, how the NRC and the ACMUI can go on for all of these years ignoring all of this relevant and well-established scientific literature that could be used to update and refine the old RG. Instead, the same clearly refuted scientific basis is repeated, and used to shackle licensees, patients and their families with unrealistic patient release criteria, as well as irrational instructions about family members needing to leave home and live elsewhere for days to weeks, for patients not to touch or be close to others, and for people to live in fear of mildly contaminated objects in their homes. The ACMUI should take the lead in dispelling these unscientific propositions, not be complicit in their prolonged improper imposition on the scientific community. If asked, the RADAR Committee would be very pleased to rewrite this document, using an appropriate scientific basis, and to provide appropriate numerical data and rational instructions to radionuclide therapy patients.
Michael G. Stabin, PhD, CHP Chair, RAdiation Dose Assessment Resource (RADAR) Committee of the Society of Nuclear Medicine and Molecular Imaging
REFERENCES AND PERTINENT LITERATURE I. Siegel JA. Nuclear Regulatory Commission Regulation ofNuclear Medicine: Guide for Diagnostic Nuclear Medicine. Reston, VA: Society of Nuclear Medicine; 2002
- 2. Siegel JA. Nuclear Regulatory Commission Regulation of Nuclear Medicine: Guide for Diagnostic Nuclear Medicine and Radiopharmaceutical Therapy. Reston, VA: Society of Nuclear Medicine; 2004
- 3. Siegel JA, Marcus CS, and Stabin MG. Licensee over-reliance on conservatisms in NRC guidance regarding the release of patients treated with 131 1. Health Phys 93:667-677, 2007
- 4. Sparks RB, Siegel JA, and Wahl RL. The need for better methods to determine release criteria for patients administered radioactive material. Health Phys 75:385-388, 1998
- 5. Siegel JA. Revised Nuclear Regulatory Commission regulations for release of patients administered radioactive materials: Outpatient Iodine-131 Anti-B 1 therapy. J Nucl Med 39 (Suppl): 28S-33S, 1998
- 6. Gates VL, Carey JE, Siegel JA, Kaminski MS, and Wahl RL. Nonmyeloablative Iodine-131 Anti-B 1 radioimmunotherapy as outpatient therapy. J Nucl Med 39: 1230-1236, 1998
- 7. Siegel JA. Outpatient radionuclide therapy. In, Radiation Protection in Medicine:
Contemporary Issues, Proceedings of the Thirty-Fifth Annual Meeting of the National Council on Radiation Protection and Measurements, Proceedings No. 21, National Council on Radiation Protection and Measurements, 1999, pp 187-199
- 8. Siegel JA, Sparks RB, and Wahl RL. An alternative to Monte Carlo in determining release criteria for patients administered radioactive material. Response to Johnson and Barnhart. Health Phys 77:726-727, 1999
- 9. Zanzonico PB, Siegel JA, and Germain JS. A generalized algorithm for determining the time of release and the duration of post-release radiation precautions following radionuclide therapy.
Health Phys 78:648-659, 2000
- 10. Siegel JA. Tracking the origin of the NRC 30-mCi rule. J Nucl Med 41 :10N-16N, 2000
- 11. Rutar FJ, Augustine SC, Colcher D, Siegel JA, Jacobson DA, Tempero MA, Dukat VJ, Hohenstein MA, Go bar LS, and Vose JM. Outpatient treatment with 1311-anti-B 1 antibody:
Radiation exposure to family members. J Nucl Med 42:907-915, 2001
- 12. Siegel J A and Rutar FJ. Possibility of internal contamination from radionuclide therapy patients released according to 10 CFR 35.75. RSO Magazine 6: 19-23, 2001
- 13. Rutar FJ, Augustine SC, Kaminski MS, Wahl RL, Siegel JA, and Colcher D. Feasibility and safety of outpatient Bexxar(R) therapy (tositumomab and Iodine 1-131 tositumomab) for non-Hodgkin's lymphoma based on the radiation doses to family members. Clinical Lymphoma 2:164-172, 2001
- 14. Siegel JA, Kroll S, Regan D, Kaminski MS, and Wahl RL. A practical methodology for patient release after tositumomab and 131 1-tositumomab therapy. J Nucl Med 43:354-363, 2002
- 15. Siegel JA and Sparks RB. Radioactivity appearing at landfills in household trash of nuclear medicine patients: Much ado about nothing? Health Phys 82:367-372, 2002
- 16. Siegel JA, Marcus CS, and Sparks RB. Calculating the absorbed dose to others from the radioactive patient: Line source model versus point source model. J Nucl Med 43: 1241-1244, 2002
- 17. Silberstein EB, Alavi A, Balon HR, Becker DV, Brill DR, Clarke SEM, Divgi C, Goldsmith SJ, Lull RJ, Meier DA, Royal HD, Siegel JA, and Waxman AD. Society ofNuclear Medicine Procedure Guideline for Therapy of Thyroid Disease with Jodine-131 (Sodium Iodide). Reston, VA: Society of Nuclear Medicine; 2006
- 18. Siegel JA, Marcus CS, and Stabin MG. Licensee over-reliance on conservatisms in NRC guidance regarding the release of patients treated with 131 1. Health Phys 93:667-677, 2007
- 19. Gulec SA and Siegel JA. Posttherapy radiation safety considerations in radiomicrosphere treatment with 90Y-microspheres. J Nucl Med 48:2080-2086, 2007
- 20. Siegel JA and Marcus CS. Released nuclear medicine patients, security checkpoints, and the NRC. J Nucl Med 49:41N-43N, 2008
- 21. Siegel J A and Silberstein EB. A closer look at the latest NRC patient release guidance. J Nucl Med 49: 17N-20N, 2008
- 22. Siegel JA and Stabin MG. Nuclear medicine patient release via the Moses algorithm: let my people go. Health Physics News XXXVIII (2):14-17, February 2010
- 23. Siegel JA and Stabin MG. RADAR response to IAEA position statement on release of radionuclide therapy patients. Health Physics News XXXVIII (5):6-7, May 2010
- 24. de Carvalho AB Jr, Stabin MG, Siegel JA, and Hunt JG. Comparison of point, line and volume dose calculations for exposure to nuclear medicine therapy patients. Health Phys 100: 185-190, 2011
- 25. Siegel JA and Silberstein EB. The AEC/NRC 30 mCi rule: regulatory origins and clinical consequences for 131 1 remnant ablative dosages. Thyroid 24(11):1625-1635, 2014
- 26. J Willegaignon, M Sapienza, C Ono, T Watanabe, M Guimarares, R Gutterres, M Marechal, C Buchpiguel. Outpatient Radioiodine Therapy for Thyroid Cancer: A Safe Nuclear Medicine Procedure. Clinical Nuclear Medicine, Volume 36, Number 6, June 2011.
- 27. J. Willegaignon,Maria I. C. Guimaraes, Michael G. Stabin, Marcelo T. Sapienza, Luiz F.
Malvestiti, Manlia M. S. Marone, Gian-Maria A. A. Sordi. Correction Factors For More Accurate Estimates Of Exposure Rates Near Radioactive Patients: Experimental, Point, And Line Source Models. Health Phys. 93(6):678-688; 2007.
Peter Crane / 6545 27 th Avenue NW / Seattle, WA 98117 / peter46crane@gmail.com June 10, 2019 Chairman Kristine L. Svinicki Commissioner Jeff Baran Commissioner Annie Caputo Commissioner David A. Wright Ms. Margaret Doane, Executive Director for Operations Ms. Marian Zobler, General Counsel Ms. Sophie Holiday, ACMUI
Dear Chairman Svinicki,
Commissioners, Ms. Doane, Ms. Zobler, and Ms. Holiday:
This afternoon, June 10, 2019, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) will hold a teleconference on the subject of patient release: the draft regulatory guide prepared by the NRC staff, and the comments on it by an ACMUI subcommittee.
Unfortunately, the emailed notification of the meeting went into my spam folder, and I only found it yesterday.
For the past 27 years, I have closely followed the issue of the release of patients made radioactive by treatment with the isotope iodine 131 (I-131). My interest in the subject originated with my having been treated with that isotope, numerous times, for thyroid cancer.
I was at the time a lawyer with the NRC.
I will just briefly review the background. The NRCs 1997 deregulation of I-131 treatments was once described to me by a Penn State nuclear medicine doctor as the worst decision made by that agency in 35 years. That was 20 years ago. Everything I have seen since confirms the soundness of his comment.
Technical advice for that rulemaking came from an elderly nuclear medicine doctor who was a prominent advocate of hormesis, the theory, considered crackpot by mainstream science, that radiation, even in what most experts would consider substantial doses, is good for you. This particular doctor, whose name I do not mention because he is deceased, was on record as believing that iodine 131 was not carcinogenic, and that if a serious nuclear accident occurred, the resulting radiation exposure could not be harmful to health and might be beneficial. He also believed, crucially, that the danger posed by released I-131 patients was exclusively from external dose. He dismissed internal dose - from ingestion, inhalation, and skin contact with I-131 - as insignificant.
Only a decade earlier, in a 1986 rulemaking, the NRC had correctly declared that I-131 presented hazards both from external and internal dose. Now, in 1997, it decided that internal 1
dose did not matter, as it enacted what may be the most drastic deregulation ever by a federal agency created to protect public health and safety. Whereas previously, release had been based on the activity level in the patient, in order to protect loved ones and others from both external and internal dose, the new rule was based on the likely external radiation dose to others.
The effect has been to make the United States, formerly a leader in the world radiation protection community, into an extreme outlier. The United States now has radiation protections far inferior to those of Bangladesh, South Africa, the Philippines, Indonesia, and many other nations. In those countries, no one leaves the hospital with more than 15 millicuries of I-131 in his or her system. In Europe, the limit is even lower than that. In the U.S., by contrast, people are being sent home to their families every day with up to 200 millicuries of I-131 in their systems, and sometimes even more.
These patients also have to get home. That often means traveling by public transportation. According to an NRC staff analysis published last year (SECY-18-0015, Staff Evaluation of the U.S. Nuclear Regulatory Commission's Program Regulating Patient Release After Radioisotope Therapy, Jan. 29, 2018), "all exposure scenarios indicate that transportation scenarios pose a radiation concern for members of the public." (Attachment 1, at p. 6.) It found that a patient with just 100 millicuries of I-131 in his or her system can deliver a radiation dose of 100 millirems (the most that a member of the public should receive from a licensed activity in a year, according to the National Council on Radiation Protection and the International Commission) to a nearby person in as little as 42 minutes. And yet the NRC staff concluded, with one courageous staff member listed as non-concurring in the paper, that no rule change is needed.
Sadly, no one who reviews the history of this issue objectively can avoid the conclusion that regulatory authorities in other countries put a higher priority on protecting children from cancer and other radiation-caused illnesses than do those in the United States. To the extent that the NRC tells itself that Americas children are just as well protected by the current rule as children in other countries, it is kidding itself. The thyroid cancer patient community certainly knows better, and if ever the NRC Commissioners would schedule a public meeting on the subject of patient release, they could hear from some patients and doctors directly.
The NRC staff deserves credit for some modest steps it has taken over the years to try to rectify, to some extent, the harm done in 1997. Thus for example, when the staffs attention was drawn to the fact that the International Commission on Radiation Protection (ICRP) had issued a report on the risk posed to others by radioactive patients,1 including the special risk to 1
ICRP Publication 94: Release of patients after therapy with unsealed radionuclides. International Commission on Radiological Protection (2005). The abstract, which explains that the ICRP is recommending a tightening of controls on exposures to young children and infants, begins as follows: After some therapeutic nuclear medicine procedures with unsealed radionuclides, precautions may be needed to limit doses to other 2
children from contamination, such as that transmitted by a parents kiss, the NRC put out a Regulatory Information Summary (RIS) encouraging doctors to consider hospitalizing patients with young children at home. This was non-binding, and though it changed nothing as a practical matter, it at least acknowledged the problem, and was frank in stating that the 1997 rule had paid insufficient attention to the risk, especially to children, from internal contamination.
A few years later, another RIS addressed the problem of radioactive patients going to hotels, saying that this practice was strongly discouraged.Again, this was non-binding, and with little or no practical effect, but at least it recognized the impropriety of discharging patients to hotels, where a pregnant or nursing mother may unwittingly absorb I-131 while cleaning the room and bathroom.
This does not mean that the NRC staff could not and should not have gone further than it has. The fact that the rule was premised on a fundamental scientific error should have led the NRC to advocate a rulemaking long ago to correct this error. After more than 20 years in which guidance to licensees has failed to solve the problems with the current rule, the staff continues to put its faith in more and better guidance, rather than a rule change, when only a rule change, imposing mandatory and enforceable requirements, can achieve any meaningful reform. If non-binding admonitions were the answer, they would have worked by now.
The draft report of the Advisory Committee on the Uses of Medical Isotopes subcommittee is problematic in several respects. The ACMUI has for years been a vigorous proponent of the view that no change is needed in the current rule. Consistent with that approach, it has consistently downplayed the risks of internal exposure, the special risks to children, and the undesirability of sending radioactive patients to hotels. (All of these, it will be noted, are areas in which the NRC staff has taken positive, if limited, steps.) The essence of the problem can be seen on the last page of the ACMUI subcommittees report, under Other Recommendations. The first one reads as follows: In the Patient Precautions and Instructions Sections, it should be emphasized that the major source of radiation dose to other individuals will be from external exposure from the patient (Ref. 1). The Ref. 1" referred to is ICRP 94, people, but this is rarely the case after diagnostic procedures. Iodine-131 results in the largest dose to medical staff, the public, caregivers, and relatives. Other radionuclides used in therapy are usually simple beta emitters (e.g. phosphorus-32, strontium-89, and yttrium-90) that pose much less risk. Dose limits apply to exposure of the public and medical staff from patients. Previously, the ICRP has recommended that a source-related dose constraint for optimisation of a few mSv/episode applies to relatives, visitors, and caregivers at home, rather than a dose limit. The present report recommends that young children and infants, as well as visitors not engaged in direct care or comforting, should be treated as members of the public (i.e. be subject to the public dose limit).
The modes of exposure to other people are: external exposure; internal exposure due to contamination; and environmental pathways. Dose to adults from patients is mainly due to external exposure. Contamination of infants and children with saliva from a patient could result in significant doses to the childs thyroid. It is important to avoid contamination of children and pregnant women. [Emphasis added.]
3
quoted above.
Now let us compare that with the way that the American Thyroid Association characterized the views of the ICRP, in comments to the NRC last year:
The International Commission on Radiological Protection (ICRP) has estimated the risk for all cancers in children is 0.1-0.2% from an effective I-131 dose of 1 mSv [1 millisievert, or 100 millirems]. Risks to children include those from external radiation exposures as well as potential ingestion of contamination from excreted or secreted I-131 from treated patients. The ATA currently recommends that having a treated parent staying in the home with children is often problematic due to childrens needs and desires to be near the treated parent.
Special arrangements should be made for children to stay with relatives or friends; alternatively, the treated parent may stay with relatives or friends where children and pregnant women are absent. In circumstances where this is not possible, inpatient isolation is an appropriate alternative. Development of lower acuity isolation facilities would help reduce the cost of inpatient isolation.
[Emphasis added.]
Why cannot the ACMUI state plainly what everyone knows to be the case: that children are far more radiosensitive to I-131 than adults, and that to children, internal exposure is a major hazard? Why does the NRC pay for stockpiles of the drug potassium iodide (KI) around nuclear power plants, if not because internal exposure to I-131 can cause cancer and other harm, especially in small children?
It is worth noting that whereas the ICRP and its domestic counterpart, the NCRP, recommend a maximum radiation dose of 100 millirems to members of the public, the NRC allows five times as much, 500 millirems, to everyone, including babies, infants, pregnant women, and babies in the womb. If the ICRP and the American Thyroid Association are correct, that means that a dose of 500 millirems to a child from I-131 creates a cancer risk of half a percent to one percent.
What benefit does the present rule confer that would compensate for a one percent cancer increase in children? Sadly, I know from experience that this is the kind of question that never gets answered, simply because there is no palatable answer. It is easier to pass over it in silence.
Kissing. It is noteworthy that neither the draft Regulatory Guide nor the ACMUI comments say anything about the risks presented when a radioactive patient kisses a child, although that was a major point made in ICRP 94. Nor does either one make the point that if a 4
radioactive patient is being transported after treatment, there should be no children in the car.
Hotels. On page 11 of the ACMUI comments, the following appears: Pg 13, Section 2.3.1, i: Add hotel to the list of examples of post treatment lodging the patient may use. This is troubling, in part because the word may has two distinct meanings. In this context, it could mean either: It is possible that a patient will go to a hotel, or Patients are permitted to go to hotels. Unless the NRC has changed its mind, and no longer thinks that it is strongly discouraged for patients to go to hotels, this ambiguous comment should not be accepted. On the contrary, the Regulatory Guide should reiterate the admonition made in the RIS.
Additional Points.
One of the issues most stressed by commenters was the need for licensees to communicate guidance to patients in a timely and comprehensible way. To do so properly would require a rule change. The NRC staff rejected this, regrettably. The discussion in the draft Regulatory Guide, includes the following, at Section 2.3.4: Prior to release of the patient, the patient should acknowledge receipt of instructions and the licensee should acknowledge the patient understands the instructions as communicated. These acknowledgments could be obtained by using a form signed by both parties.[Emphasis added.] I stress the word could just to make the point that the guidance here is so feeble. The NRC will not even go so far as to say, in guidance that it stresses is non-binding, that this is something that licensees should do, unless there are issues, such as illiteracy, that stand in the way.
Under 10 CFR 35.75, if a licensee cannot find that a patients exposure of others will be under 500 millirems, it cannot release the patient - no ifs, ands, or buts. The draft Regulatory Guide makes this point, under Section 2.3.2., Patient Precautions, but because the entire Guide is declared to be non-binding (e.g., compliance with RGs is not required, at page 2),
the reader may not realize that this is a requirement of the regulations, and thus has the force of law. Clarification may be helpful.
I appreciate the opportunity to submit these comments.
Respectfully, Peter Crane Counsel for Special Projects, USNRC (retired) 5