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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 P R O C E E D I N G S 1
2:02 p.m.
2 MR. EINBERG: Good afternoon, everyone.
3 As the Designated Federal Officer for this meeting, 4
I am pleased to welcome you to the public meeting of 5
the Advisory Committee on the Medical Uses of Isotopes.
6 My name is Chris Einberg. I'm the Chief of the Medical 7
Safety and Events Assessment Branch, and I've been 8
designated as the federal officer for this advisory 9
committee meeting in accordance with 10 CFR 7.11.
10 Present today, we have Lisa Dimmick, our 11 Medical Radiation Safety Team Leader, and Kellee 12 Jamerson, our ACMUI coordinator, as Designated Federal 13 Officers for the ACMUI.
14 This is an announced meeting of the 15 Committee that is being held in accordance with the 16 rules and regulations of the Federal Advisory Committee 17 Act and the Nuclear Regulatory Commission. This 18 meeting is being transcribed by the NRC, and it may 19 also be transcribed or recorded by others. The meeting 20 was announced in the May 9th, 2019 edition of the Federal 21 Register, Volume 84, page 20439.
22 The purpose of this meeting is to discuss 23 the revised ACMUI bylaws and the draft report of the 24 ACMUI Regulatory Guide 8.39 Subcommittee. In its 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 report, the Subcommittee provides recommendations with 1
respect to Phase 1 of the revisions to the Reg Guide 2
8.39, Release of Patients Administered Radioactive 3
Material.
4 The function of the ACMUI is to advise staff 5
on the issues and questions that arise on the medical 6
use of byproduct material. The Committee provides 7
counsel to the staff but does not determine or direct 8
the actual decisions of the staff or the Commission.
9 The NRC solicits the views of the Committee and values 10 their opinions. I request that, whenever possible, 11 we try to reach a consensus on the various issues that 12 we will discuss today, but I also recognize there may 13 be minority or dissenting opinions. If you have such 14 opinions, please allow them to be read into the record.
15 At this point, I'd like to perform the roll 16 call of the ACMUI members participating today. Dr.
17 Christopher Palestro, Chairman, nuclear medicine 18 physician.
19 CHAIRMAN PALESTRO: Present.
20 MR. EINBERG: Dr. Darlene Metter, Vice 21 Chairman, Diagnostic Radiologist.
22 VICE CHAIRMAN METTER: Here.
23 MR. EINBERG: Dr. Vasken Dilsizian, 24 Nuclear Cardiologist.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER DILSIZIAN: Here.
1 MR. EINBERG: Dr. Ronald Ennis, Radiation 2
Oncologist.
3 (No audible response.)
4 MR. EINBERG: Mr. Richard Green, Nuclear 5
Pharmacist.
6 MEMBER GREEN: Present.
7 MR. EINBERG: Ms. Melissa Martin, Nuclear 8
Medicine Physicist.
9 MEMBER MARTIN: Here.
10 MR. EINBERG: Dr. Michael O'Hara, FDA 11 Representative.
12 MEMBER O'HARA: Here.
13 MR. EINBERG: Mr. Zoubir Ouhib, Radiation 14 Therapy Physicist.
15 MEMBER OUHIB: Here.
16 MR. EINBERG: Dr. A. Robert Schleipman, 17 Healthcare Administrator.
18 MEMBER SCHLEIPMAN: Present.
19 MR.
EINBERG:
Mr.
Michael
- Sheetz, 20 Radiation Safety Officer.
21 MEMBER SHEETZ: Present.
22 MR. EINBERG: Ms. Megan Shober, State 23 Government Representative.
24 MEMBER SHOBER: Here.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. EINBERG: Ms. Laura Weil, Patients' 1
Rights Advocate.
2 (No audible response.)
3 MR. EINBERG: Dr. Harvey Wolkov, Radiation 4
Oncologist.
5 MEMBER WOLKOV: Present.
6 MR. EINBERG: Okay. We have a quorum with 7
at least six members present. I would add that all 8
members of the ACMUI are subject to federal ethics laws 9
and regulations and receive annual training on these 10 requirements. If a member believes that he or she may 11 have a conflict of interest, as that term is broadly 12 used within 5 CFR Part 2635 with regards to an agenda 13 item to be addressed by the ACMUI, this member should 14 divulge it to the Chair and to the DFO as soon as possible 15 before the ACMUI discusses it as an agenda item.
16 ACMUI members must recuse themselves from 17 participating in any agenda item which they may have 18 a conflict of interest unless they've received a waiver 19 or prior authorization from their appropriate NRC 20 official.
21 I now ask that NRC members, staff members 22 who are present to identify themselves. I'll start 23 with the individuals in the room.
24 MR. SCHLOM: Halfon Schlom.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MR. EINBERG: Okay.
1 MS. DIMMICK: Lisa Dimmick, Medical 2
Radiation Safety Team Leader.
3 MS. HOUSEMAN: Esther Houseman, Attorney.
4 DR. DAIBES: Said Daibes, Medical Team.
5 MS.
HOLIDAY:
Sophie
- Holiday, 6
Enforcement.
7 MS. JAMERSON: Kellee Jamerson, Medical 8
Team.
9 MS. KARAGIANNIS: Harriet Karagiannis, 10 Office of Research.
11 MR. EINBERG: Thank you. Are there NRC 12 members on the phone? Sophie is indicating to me that 13 they're on a muted line and can't say who's on the line.
14 Members of the public who notified Ms.
15 Jamerson that you will be participating in the 16 teleconference will be captured in the transcript.
17 Those of you who did not provide prior notification, 18 please contact Ms.
Jamerson at 19 kellee.jamerson@nrc.gov, that's K-E-L-L-E-E, dot, 20
- Jamerson, J-A-M-E-R-S-O-N,
@nrc.gov or at 21 301-415-7408, at the conclusion of this meeting.
22 We also have a bridgeline available, and 23 that phone number is 888-282-1673. The pass code to 24 access the bridgeline is 6240665.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 The meeting is also using the GoToWebinar 1
application to view presentations in real-time. You 2
can access this by going to www.gotowebinar.com and 3
searching for the meeting ID 386468939. Let me repeat 4
that: 386468939.
5 Individuals who would like to ask a 6
question or make a comment regarding a specific topic 7
the Committee has discussed should dial *1 to signal 8
the operator that you wish to speak. Please clearly 9
state your first and last name for the record.
10 Comments and questions are typically 11 addressed by the Committee near the end of the 12 presentation. After the Committee has fully discussed 13 the topic, we will notify the operator when we are ready 14 for the public comment period of the meeting.
15 I would also like to add that the handouts 16 and agenda for this meeting are available on the NRC's 17 public website.
18 At this time, I ask everyone on the call 19 who is not speaking to please place your phone on mute.
20 If you do not have the capability to mute your phone, 21 please press *6 to utilize the conference line mute 22 and unmute functions. I would also ask everyone to 23 exercise extreme care to ensure that background noise 24 is kept at a minimum, as any stray background sounds 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 can be very disruptive on a conference call this large.
1 At this point, I would like to turn the 2
meeting over to Ms. Lisa Dimmick, who will provide some 3
additional remarks regarding our process for revising 4
5 MS. DIMMICK: Thank you, Chris. Good 6
afternoon. I'm Lisa Dimmick, the Medical Radiation 7
Safety Team Leader. I would like to provide some 8
additional background on the purpose of today's 9
meeting.
10 As you know, the purpose of this meeting 11 is to discuss the revised ACMUI bylaws and the draft 12 report of the ACMUI Regulatory Guide 8.39 Subcommittee.
13 In its
- report, the Subcommittee provides 14 recommendations with respect to Phase 1 of the revisions 15 of Regulatory Guide 8.39, Release of Patients 16 Administered Radioactive Material.
17 It's important to note and to understand 18 that Regulatory Guide 8.39 is being revised in two 19 phases. Phase 1, updates the patient release guidance, 20 including information for patient instruction and 21 updates to Table 3,
Reactivity of the 22 Radiopharmaceuticals that Require Instruction and 23 Records when Administered to Patients who are 24 Breastfeeding an Infant or Child, as well as introduces 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a new section titled Death of a Patient Following 1
Radiopharmaceutical Administration or Implant. The 2
Phase 2 update will update the dosimetric equations, 3
methodologies, and tables used to calculate dose to 4
members of the public from released patients.
5 The Subcommittee's report and 6
recommendation on this preliminary draft proposed 7
Regulatory Guide 8.39, Revision 1, will only pertain 8
to the Phase 1 update. This preliminary draft was 9
provided to the ACMUI for its review and comment for 10 staff consideration. The NRC staff will evaluate the 11 ACMUI's comments following today's meeting. The draft 12 Reg Guide 8.39 will then be published in the Federal 13 Register for public comment.
14 Thank you. And I will now turn the meeting 15 over to Dr. Palestro.
16 CHAIRMAN PALESTRO: All right. Thank 17 you, Lisa. This is Dr. Palestro. The first item on 18 the agenda is to discuss the revised 2019 Advisory 19 Committee on Medical Uses of Isotopes Bylaws. At this 20 point, I would ask Ms. Weil to provide this.
21 MS. HOLIDAY: Dr. Palestro, this is Sophie 22 Holiday.
23 CHAIRMAN PALESTRO: Yes.
24 MS. HOLIDAY: I was actually going to do 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the presentation on this, as this is incorporation of 1
the comments that the ACMUI Bylaws Subcommittee 2
provided in its spring meeting, which was unanimously 3
endorsed by the Committee.
4 CHAIRMAN PALESTRO: All right. That's 5
fine.
6 MS. HOLIDAY: Okay. Everyone should be 7
able to see on their screen a copy of the proposed draft 8
bylaws. And the changes in here are both minor 9
editorial, as well as changes that conform to the 10 recommendations that the ACMUI endorsed during its 11 April 2019 meeting here at headquarters.
12 So, what you see here on the screen in 13 yellow highlight, the changes are noted in yellow 14 highlight so that everyone can clearly see what the 15 changes are. This is what I would consider a minor 16 edit, which is to simply update the bylaws to reflect 17 the current name of our division and our office. So, 18 it now reads Division of Material Safety, Security, 19 State and Tribal Programs, MSST, Office of Nuclear 20 Material Safety and Safeguards, NMSS.
21 Here what you see is page three of the 22 bylaws, which is Section 1.3.6. This is directly 23 related to the objective of the previous bylaw 24 subcommittee, which was to review the Chair's 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 involvement in subcommittees. The new text reads: In 1
matters where the ACMUI Chair's unique experience and 2
knowledge would be especially informative, the chair 3
may serve on relevant subcommittees. The chair will 4
serve at the discretion of the subcommittee members.
5 However, the ACMUI chair will not chair the 6
subcommittees.
7 Okay. In Section 4, conduct of members, 8
specifically Section 4.1, there has been revised 9
language to reflect the conversation that the ACMUI 10 had related to conflicts of interest. Particularly, 11 the Committee wanted there to be clear distinct language 12 in the bylaws that identifies when ACMUI members must 13 recuse themselves. So, the new text reads as follows:
14 All members of the ACMUI are subject to federal ethics 15 laws and regulations and receive annual training on 16 these requirements. If a member believes that he or 17 she may have a conflict of interest, as that term is 18 broadly used within 5 CFR Part 2635, with regard to 19 an agenda item to be addressed by the ACMUI, this member 20 should divulge it to the Chair and the DFO as soon as 21 possible and before the ACMUI discusses it as an agenda 22 item. ACMUI members must recuse themselves from 23 participating in any agenda item in which they may have 24 a conflict of interest unless they receive a waiver 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 or prior authorization from the appropriate NRC 1
official.
2 This language was provided to us from the 3
Office of General Counsel, as was discussed during the 4
April 2019 ACMUI meeting. The ACMUI voted for us to 5
work with the Office of General Counsel to provide us 6
with the appropriate language, and this is what they 7
have provided.
8 Okay. That concludes the proposed 9
amendments to the bylaws. What I have on the screen 10 here is just to show everybody that, per the bylaw 11 Section 5.1, it states that amendment of these bylaws 12 shall require an affirmative vote of two-thirds of the 13 current ACMUI membership and the concurrence of the 14 director of Nuclear Material Safety and Safeguards.
15 So at this time, Dr. Palestro, I would like 16 to ask if there's a motion on the table to approve the 17 amended bylaws.
18 CHAIRMAN PALESTRO: That's fine. Is 19 there a motion.
20 MEMBER WOLKOV: This is Dr. Harvey Wolkov.
21 So moved.
22 CHAIRMAN PALESTRO: Second?
23 VICE CHAIRMAN METTER: This is Darlene 24 Metter. Second.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN PALESTRO: Any discussion?
1 MS. HOLIDAY: I'm sorry. Go ahead, Dr.
2 Palestro.
3 CHAIRMAN PALESTRO: Any discussion? Ms.
4 Holiday, I'm sorry. You were going to say something 5
and I cut you off.
6 MS. HOLIDAY: That's okay. I was just 7
going to say for the record I have Dr. Wolkov as making 8
the motion and Dr. Metter as seconding.
9 CHAIRMAN PALESTRO: All right. Any 10 discussion? Any comments or discussion from the 11 public?
12 MEMBER OUHIB: Dr. Palestro, this is 13 Zoubir.
14 CHAIRMAN PALESTRO: Yes, Zoubir?
15 MEMBER OUHIB: Just a comment on item 1.3.6 16 where it says the Chair may serve on relevant 17 subcommittees. What level would that be? As a voting 18 member, as a consultant, or what?
19 CHAIRMAN PALESTRO: Given that it's not 20 specified, and Ms. Holiday or Mr. Einberg or Ms.
21 Dimmick, correct me if I'm wrong, would serve on the 22 relevant subcommittee with all of the rights of other 23 members of the subcommittee. That would be my 24 understanding.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER SCHLEIPMAN: Hello, this is Robert 1
Schleipman. The very first sentence mentions that the 2
Chair may vote.
3 MS.
HOLIDAY:
That is also our 4
understanding.
5 CHAIRMAN PALESTRO: I'm sorry, Ms.
6 Holiday.
7 MS. HOLIDAY: I was saying, Dr. Palestro, 8
that is also our understanding.
9 CHAIRMAN PALESTRO: All right. Thank 10 you. Any other questions or discussion? All right.
11 Hearing none, all in favor.
12 (Chorus of aye.)
13 CHAIRMAN PALESTRO: Any opposed?
14 (No audible response.)
15 CHAIRMAN PALESTRO: Any abstentions?
16 (No audible response.)
17 CHAIRMAN PALESTRO: And, again, as I did 18 at the April meeting, I will abstain, but, once again, 19 I want the record to reflect that my abstention does 20 not in any way indicate my agreement or disagreement 21 with the proposed revisions but rather the fact that 22 this, as the current chair, is a potential conflict 23 of interest for me.
24 MS. HOLIDAY: Thank you so much. Okay.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 That concludes topic one. Whenever you are ready to 1
proceed to topic two.
2 CHAIRMAN PALESTRO: All right. If we can 3
then move on to topic two, which is the draft proposed 4
Regulatory Guideline 8.39, The Release of Patients 5
Administered Radioactive Materials, Revision 1, Phase 6
- 1. And, again, just to re-emphasize that Phase 1, which 7
is what we are addressing today, updates patient release 8
guidance, including the information for patient 9
instructions and updates to Table 3, as well as a new 10
- section, Death of a
Patient Following 11 Radiopharmaceutical Administration or Implants.
12 At this point, I will turn the session over 13 to Mr. Michael Sheetz, Chair of the Subcommittee.
14 MEMBER SHEETZ: Thank you, Dr. Palestro.
15 This is Michael Sheetz. I'd like to provide an 16 overview of the ACMUI Subcommittee comments on the draft 17 proposed Reg Guide 8.39, Release of Patients 18 Administered Radioactive Materials, Revision 1, Phase 19
- 1.
20 The other subcommittee members are Dr.
21 Vasken Dilsizian, Ms. Melissa Martin, Dr. Robert 22 Schleipman, Ms. Megan Shober, Ms. Laura Weil, and our 23 NRC staff resource, Dr. Said Daibes - Figueroa.
24 For background, the NRC's current Reg Guide 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 8.39 Revision 0 was issued in April of 1997 following 1
the rule change in 10 CFR 35.75 to allow for the release 2
of patients administered radioactive material on a 3
solely dose-based criteria. Since that time, there 4
have been several challenges to the appropriateness 5
of the release criteria and the associated precautions 6
that are required to be provided to minimize radiation 7
exposure to other individuals from the released 8
patient.
9 The NRC requested public comments on the 10 patient release program in 2017 to receive input on 11 whether additional or alternative criteria are needed 12 and to determine whether regulatory changes to the NRC's 13 patient release program are warranted. The NRC also 14 created a web page to provide patients with standardized 15 information on radioactive iodide treatment procedures 16 so that the patients will understand the reason for 17 the procedures, the process, and how to reduce radiation 18 exposure to others.
19 As stated previously, it should be noted 20 that Reg Guide 8.39 is being revised in two phases.
21 This first Phase 1 revision updates the patient release 22
- guidance, including information for patient 23 instructions, and updates to Table 3 entitled 24 Activities of Radiopharmaceuticals that Require 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Instructions and Records When Administered to Patients 1
who are Breastfeeding an Infant or Child.
2 In Phase 2, which will come later, the 3
dosimetric equations, methodologies, and tables used 4
to calculate dose to members of the public from released 5
patients will be updated. The following Subcommittee 6
comments and recommendations only pertain to this Phase 7
1 revision, as we did not address the dosimetric 8
equations and methodologies.
9 In the direct report, we published 10 approximately 40 directed changes pertaining to the 11 wording, items of emphasis, and formatting of the 12 document. In consideration of everyone's time, I will 13 not be repeating these. However, if anyone has a 14 specific question or concern related to any of the 15 direct changes, we will certainly entertain them.
16 I
would like to highlight the 17 Subcommittee's main comments and recommendations on 18 the draft reg guide. First, the Subcommittee supports 19 the addition of a table of contents to the Reg Guide 20 and expanding the section on content of instructions 21 to include subsections on pretreatment discussions, 22 patient precautions, patient instructions, and patient 23 acknowledgment of instructions. While we recognize 24 that some of these subsections are not required in the 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 regulation, they are reasonable components of a strong 1
patient instruction program and will help to assure 2
patient planning and comprehension.
3 Second, in Tables 1 and 2, entitled 4
Activities and Dose Rates for Authorizing Patient 5
Release and When Instruction Should be Provided, these 6
tables should be updated to include the new and 7
potential radionuclides to be used in the future.
8 Third, Table 3 entitled Activities of 9
Radiopharmaceuticals that Require Instructions and 10 Records when Administered to Patients who are 11 Breastfeeding an Infant or Child, also this table should 12 be updated to include the radionuclides activities and 13 recommended duration of interruption of breastfeeding, 14 as contained in the ACMUI Subcommittee report on nursing 15 mother guidelines for medical administration of 16 radioactive materials, final report, dated January 17 31st, 2019.
18 Fourth, in the patient precautions and 19 instructions sections, we support the addition of 20 instructions for evaluation of holding trash to allow 21 for radioactive decay as the landfill will likely detect 22 the radiation and send the trash back to the patient, 23 providing information to a family member or caregiver 24 to contact the treating medical facility if the patient 25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 has a medical emergency or passes away, and warning 1
that the patient may trigger the radiation detector 2
alarms at airports and national borders for several 3
weeks or months.
4 Fifth, in the patient precautions and 5
instructions sections, while most of the precautions 6
address contamination control, it should be emphasized 7
that the major source of radiation dose to other 8
individuals will be from external exposure from the 9
patient, and so this should be the primary focus. Also, 10 after completion of the Phase 2 revisions, these 11 sections should also include the recommended time 12 period for following the precautions. While the list 13 of precautions for patients to follow is fairly 14 standardized, the time period to follow these 15 precautions is highly variable.
16 And, sixth, the Subcommittee supports the 17 addition of a new section on death of a patient following 18 radiopharmaceutical administration or implants. Most 19 of our directed changes to this section were to format 20 and organize the information by type of postmortem 21 activity, such as autopsy, embalming, funeral, burial, 22 and cremation. Whichever the event, we feel that the 23 RSO is the primary person to be notified to determine 24 the amount of activity remaining in the deceased 25
24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 patient, determine what precautions should be taken, 1
and to determine if there are any applicable state or 2
municipal restrictions.
3 While there is adequate guidance on the 4
precautions to take to minimize radiation exposure for 5
postmortem activities of a patient who has died after 6
being administered a
therapeutic quantity of 7
radioactive material, there is little or no consistent 8
guidance on what retained activity or time period for 9
when the precautions should be followed. The 10 Subcommittee recommends that a dose-based model be 11 developed to provide guidance on when precautions or 12 restrictions would be appropriate following the death 13 of a patient administered a therapeutic quantity of 14 radioactive material.
15 That concludes the Subcommittee report.
16 CHAIRMAN PALESTRO: Comments from the 17 Subcommittee members? Comments from the ACMUI 18 Committee members?
19 VICE CHAIRMAN METTER: This is Darlene 20 Metter. I have a couple of comments to make. I thank 21 you for making the recommendations to comply with the 22 nursing mother guidelines final report.
23 I'd also like to make a comment that there 24 was an item there that talked zirconium-80. I don't 25
25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 think that was in the nursing mothers guideline. I 1
think that might have been a typo, so it should be 2
zirconium-89. And also I agree with all the other 3
recommendations which are listed in the table of the 4
nursing mother guidelines.
5 Number two is I just have a question that 6
why did the ACMUI Subcommittee start with the 7
recommendations, why didn't they start with the 8
methodology? Because if thats stage two, there's a 9
change in the methodology, then you'll have to change 10 your appropriate recommendations for the public. And 11 I'm just kind of wondering if maybe you should have 12 done the methodology first to get your exposure limits 13 and then go back and make the recommendations.
14 That's it. Those are my two comments.
15 CHAIRMAN PALESTRO: Mr. Sheetz?
16 MEMBER SHEETZ: It was my understanding 17 that we were to address the revisions from Phase 1 and 18 not comment on the methodologies. That will come in 19 Phase 2.
20 VICE CHAIRMAN METTER: This is Darlene 21 Metter again. It's just that if we change the 22 methodology, then those recommendations will need to 23 be changed also, I suspect. You know what I mean?
24 CHAIRMAN PALESTRO: I'm sorry. This is 25
26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Dr. Palestro. I think I understand what you're saying, 1
Dr. Metter, and I understand these were the instructions 2
that were given to Mr. Sheetz. I think maybe this is 3
a question that staff is best suited to answer as to 4
why Phase 1 included what it did, as opposed to, say, 5
the methodology first.
6 MS. DIMMICK: Hi, this is Lisa Dimmick, 7
Medical Radiation Safety Team Leader. So, when staff 8
completed its evaluation for patient release at the 9
end of 2017 and going into 2018, we had identified in 10 the Commission paper that Reg Guide 8.39 would be 11 updated in a phased approach, a Phase 1 approach and 12 then the Phase 2. We were also evaluating or responding 13 to previous Commission direction to update Regulatory 14 Guide 8.39 to encompass all of its instructional 15 information on patient release that was included in 16 generic communications and other guidance documents 17 to consolidate it for one location. So, we had 18 resources available to begin a Phase 1 approach to 19 evaluate or include the guidance information, so that 20 was the path we took.
21 CHAIRMAN PALESTRO: Thank you. Does that 22 answer your question, Dr. Metter?
23 VICE CHAIRMAN METTER: I can see what they 24 did, but it just would make it difficult. If there's 25
27 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a change in the methodology, then the radiation limits 1
may change and then the instructions may need to change 2
and you'll have to go back and redo the recommendations.
3 That would just be what I would think, but I can see 4
that, you know, what you've put forth as Phase 1 and 5
Phase 2.
6 CHAIRMAN PALESTRO: I understand your 7
point, Dr. Metter, and I think it's a point well taken.
8 At this point, it's moot because it's already begun.
9 It certainly would be something to keep in mind for 10 future revisions.
11 Other comments from the ACMUI?
12 VICE CHAIRMAN METTER: I have another 13 comment. This is Darlene --
14 CHAIRMAN PALESTRO: Yes, Dr. Metter.
15 VICE CHAIRMAN METTER: Regarding the 16 issues with disposable plates for the individual who 17 has received radioactive material and disposable 18 utensils and the making of radioactive waste and setting 19 off landfills, I don't know how many people do this, 20 but I generally do not encourage my patients to use 21 disposable utensils or plates because of that 22 particular concern. And I just have them use regular 23 plates, a regular plate or a set of dishes that they 24 use for themselves and they wash themselves because 25
28 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 everything just goes down the drain and you don't have 1
to deal with radioactive waste. And they just put that 2
aside for their sole use during the time that they need 3
to be more careful of their exposures to other people.
4 And I don't know if other individuals recommend this 5
for their patients, and maybe we should actually make 6
that, this is what I would prefer, rather than making 7
radioactive waste that then the patients would have 8
to decay and then that would be more work for them.
9 But if they just wash their dishes, there's no need 10 to hold any disposable items for radioactive decay.
11 CHAIRMAN PALESTRO: Thank you, Dr. Metter.
12 Any comments in response to Dr. Metter's statement?
13 MEMBER SCHLEIPMAN: Robert Schleipman.
14 That was our same practice to recommend to patients, 15 if they're capable of doing so, to wash their own dishes 16 and not discard items that could potentially set off 17 landfill alarms.
18 CHAIRMAN PALESTRO: Thank you, Dr.
19 Schleipman. Other comments?
20 MEMBER MARTIN: This is Melissa Martin.
21 VICE CHAIRMAN METTER: Go ahead, Melissa.
22 MEMBER MARTIN: I was just going to say 23 I would certainly support that as an alternative or 24 a recommended alternative and maybe we can phrase it 25
29 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 that way. In lieu of using disposable plates and 1
silverware, an option would be to use a designated set 2
of dishes handled only by the patients.
3 VICE CHAIRMAN METTER: This is Darlene 4
Metter. I actually would make that the recommendation.
5 The alternative would be the disposable because I think 6
that would make more sense to me.
7 MEMBER MARTIN: That's fine with me, too.
8 We've used the same recommendation. We've just told 9
them put everything you can, create as little trash 10 as possible by using the alternative method that you've 11 suggested.
12 CHAIRMAN PALESTRO: This is Dr. Palestro.
13 We follow that procedure, as well. We always 14 recommended to patients that, whenever possible, use 15 an isolated set of utensils and dishes and wash them 16 separately, rather than disposable items, for the exact 17 reasons that that's been mentioned.
18 Other comments?
19 MEMBER SHEETZ: This is Mike Sheetz. I 20 agree that the amount of waste that a patient generates 21 should be minimized and disposable should be 22 discouraged, but there will always be potentially some 23 items, you know, diapers, Depends, tissues, and things 24 that will end up potentially in the trash that could 25
30 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 trigger a waste alarm. And I guess my point was that 1
the institution should evaluate that potential, 2
depending on their state, and be able to provide 3
guidance to the patient appropriately.
4 In Pennsylvania, all of the landfills have 5
radiation monitors, but they also are permitted to 6
dispose of anything radioactive that has a medical 7
radioisotope. And so it never comes back to the 8
patient. So in Pennsylvania, it really doesn't matter 9
if they generate radioactive trash. It's not going 10 to come back to them. Other states it may be different.
11 And so I think the point that I was trying to make 12 that there's an evaluation of that, you know, by the 13 institution depending on the state they're in.
14 CHAIRMAN PALESTRO: Other comments?
15 Comments from the public?
16 MS. JAMERSON: Dr. Palestro?
17 CHAIRMAN PALESTRO: Yes.
18 MS. JAMERSON: This is Kellee Jamerson.
19 I'd just like to ask Mr. Sheetz if they're going to 20 revise their recommendation.
21 MEMBER SHEETZ: You want me to recite the 22 recommendations?
23 MS. JAMERSON: Are you going to revise per 24 the discussion you just had regarding the utensils, 25
31 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 disposable utensils?
1 MEMBER SHEETZ: I guess we can revise the 2
statement and the instructions -- I don't have it 3
directly in front of me -- to, you know, encourage the 4
use of regular dishware so that it can be washed and 5
not using disposable.
6 CHAIRMAN PALESTRO: Do we have the exact 7
verbiage as it stands now?
8 MEMBER SCHLEIPMAN: Robert Schleipman.
9 It's on page 31 under Section 2.3.3, use dedicated or 10 disposable kitchen utensils and do not share them with 11 others. So dedicated would include their own, I 12 suppose, right?
13 MS. JAMERSON: Correct.
14 VICE CHAIRMAN METTER: This is Darlene 15 Metter. Maybe since we weren't quite sure about it, 16 maybe we should clarify that word dedicated so that 17 the public can understand.
18 CHAIRMAN PALESTRO: I'm sorry. Dr.
19 Schleipman, could I ask you to read that again?
20 MEMBER SCHLEIPMAN: Yes. It's, quote, 21 use dedicated or disposable kitchen utensils and don't 22 share them with others, end quote.
23 MS. HOLIDAY: Dr. Palestro, this is 24 Sophie.
25
32 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN PALESTRO: Yes.
1 MS. HOLIDAY: If I could add on, the page 2
right before that also says under the fourth sub-bullet, 3
encourage the use of kitchen utensils dedicated to the 4
patient, not shared with other household members, and 5
wash separately from other dishes. Alternatively, 6
encourage patient to use disposable eating utensils.
7 So I think -- I'm sorry. I think Dr. Metter was 8
suggesting that we recommend defining what dedicated 9
means, but I believe the statement that I just read, 10 which is on page 30 of the preliminary draft proposed 11 Reg Guide, kind of clarifies that by saying dedicated 12 to the patient, comma, not shared with other household 13 members.
14 CHAIRMAN PALESTRO: Dr. Metter?
15 VICE CHAIRMAN METTER: Yes, that sounds 16 very appropriate.
17 MEMBER MARTIN: This is Melissa. I would 18 agree with that language also.
19 MS. HOLIDAY: So then it would sound like 20 there is no recommendation to revise the report because 21 the language is adequately captured in the draft 22 proposed Reg Guide.
23 MEMBER MARTIN: Correct.
24 CHAIRMAN PALESTRO: Thank you. Any other 25
33 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 discussion on this point?
1 MEMBER OUHIB: This is Zoubir. Just minor 2
comments. On page 18, regarding the patient 3
instructions, what happens if you have a language 4
barrier? That's item 2.1.
5 MS. HOLIDAY: Oh, you mean page 24 of the 6
draft proposed Reg Guide.
7 MEMBER OUHIB: I guess I'm going from 8
another copy here. Sorry about that.
9 MS. HOLIDAY: You're referencing Section 10 2.1 titled Activities and --
11 MEMBER OUHIB: That is correct.
12 MS. HOLIDAY: -- Requiring Instruction?
13 MEMBER OUHIB: That is correct. If you're 14 dealing with a patient that has a language barrier, 15 you know, where's the provision there? What are we 16 recommending?
17 CHAIRMAN PALESTRO: This is Dr. Palestro.
18 Isn't there a provision in this guidance that suggests, 19 and I can't quote it exactly, but that it's the 20 responsibility of the licensee to determine the 21 individual's ability to follow the instructions?
22 MEMBER OUHIB: But it doesn't give any 23 detail on that. It says it also provides the licensee 24 with the opportunity to determine if the patient will 25
34 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 be able to follow the release instruction, but then 1
what? What if the patient cannot follow the 2
instruction? There are no other recommendations after 3
that. Or what are the steps? As a matter of fact, 4
that was one of the items that I had also.
5 MEMBER SHEETZ: This is Mike Sheetz. In 6
Section 2.3.4, patient acknowledgment of instructions, 7
there is a statement there, prior to release of the 8
patient, patient should acknowledge receipt of 9
instructions and the licensee should acknowledge the 10 patient understands the instructions as communicated, 11 so I think it's addressed.
12 MEMBER OUHIB: I'm not sure if that's 13 sufficient.
14 CHAIRMAN PALESTRO: What would you 15 recommend, Zoubir?
16 MEMBER OUHIB: To be honest with you, Dr.
17 Palestro, I haven't thought about it, other than perhaps 18 the licensee should probably take every step possible 19 to ensure that the patient fully understands the 20 instructions, including any language barrier or 21 whatnot, you know, where they use, I don't know, an 22 institution have people that can translate and so on 23 and so forth. I don't know. I don't have the verbiage 24 for that.
25
35 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN PALESTRO: My own opinion is that 1
it's already amply covered in the guidance, but other 2
opinions?
3 VICE CHAIRMAN METTER: This is Darlene 4
Metter. When we consent patients for therapy, for, 5
let's say, I-131 therapy, and they speak a different 6
language than the person consenting them, we have an 7
official hospital translator and it's documented in 8
the report that all questions were answered through 9
the translator.
10 And the other thing on 2.3.3, it says 11 patient instructions, it says that, you know, the 12 licensee has to comply with 10 CFR 35.75, et cetera, 13 and it says, however, once a patient is released, the 14 licensee has no control of the patient. So, you know, 15 I think you can only do so much. If you ask the patient 16 if they acknowledge, and I believe, I like the idea 17 that the Subcommittee recommended this acknowledgment 18 by the patient and we have a translator and the patient 19 signs it, to me, that's legal documentation that the 20 patient acknowledges that they understand the 21 instructions and the consequences if these are not 22 followed.
23 CHAIRMAN PALESTRO: I'm sorry. Dr.
24 Schleipman.
25
36 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MEMBER SCHLEIPMAN: At our institution, 1
we had numerous translated documents in several 2
languages and brought in official interpreters. Not 3
every institution will have those resources, but I think 4
that the general instructions in the regulatory guide 5
really put the onus on the institution and I think it's 6
sufficiently worded, as well.
7 CHAIRMAN PALESTRO: Zoubir?
8 MEMBER OUHIB: Yes.
9 CHAIRMAN PALESTRO: Does that answer your 10 question? Do you wish to make a motion to revise the 11 report?
12 MEMBER OUHIB: I guess that's probably, 13 to a certain point, convincing maybe. And I would agree 14 with some of the comments that the majority of the 15 institutions have translators and all that, but that's 16 not available at every institution, and that is when 17 there's always a chance of something going wrong.
18 CHAIRMAN PALESTRO: I think we all agree 19 with you, but, again, the onus is on the licensee to 20 make that determination.
21 MEMBER OUHIB: Agree.
22 CHAIRMAN PALESTRO: All right. Thank 23 you. Any other comments, discussion from the ACMUI?
24 MEMBER OUHIB: I do have one on item 2.4, 25
37 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 death of a patient following radiopharmaceutical 1
administration or implant. Unless I misread it or 2
misunderstood, are we saying somehow that it is okay 3
to cremate under certain conditions?
4 MEMBER SHEETZ: This is Mike Scheetz. No, 5
that's one of the recommendations. I mean, there are 6
precautions and maybe restrictions that need to be 7
taken, but there needs to be some dose-based model 8
created to recommend what activity levels or at what 9
time period after administration of radioactive 10 material implant per patient do the precautions or 11 restrictions need to apply. So, there may be 12 situations where a patient has been administered 13 radioactive material and the recommendation would be 14 not to cremate that body.
15 MEMBER OUHIB: Okay. Are those stated 16 clearly in this here? Because I didn't see that for 17 some reason. I was like wait a minute, aren't we saying 18 something that we're not recommending elsewhere?
19 MEMBER MARTIN: No, I think it's covered 20
-- I'm sorry. This is Melissa. I think it's under 21 other recommendations, number two. It basically says 22 the development of this will be part of the part two 23 revision. It will be a new dose-based model because 24 you can have a patient with a prostate implant that's 25
38 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 20 years old. They could very well cremate that patient 1
without a problem. If the patient had a prostate 2
implant last week, then you don't. It all comes down 3
to the dose-based model.
4 MEMBER OUHIB: I hear you. Okay.
5 CHAIRMAN PALESTRO: Does that answer your 6
question, Zoubir?
7 MEMBER OUHIB: Yes. Thank you.
8 CHAIRMAN PALESTRO: Thank you. Any other 9
comments or questions?
10 MEMBER OUHIB: One last item, Dr.
11 Palestro.
12 CHAIRMAN PALESTRO: Yes, sir.
13 MEMBER OUHIB: 3.1, records of release, 14 item number two, for immediate release of a patient 15 based on measured dose rate. I see here we put the 16 result of the measurement, the specific survey 17 instrument. Should we add a calibration information 18 of that survey instrument?
19 MEMBER MARTIN: I think, as long as the 20 institution has got the record of it, that's all you 21 need.
22 MEMBER OUHIB: Well, that applies to the 23 survey instrument also. They have that information, 24 too. But I think I would depict that one of the two, 25
39 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 I think the calibration information is more important 1
than the specific survey instrument information.
2 MEMBER GREEN: This is Richard Green. If 3
the operator records the survey instrument that was 4
used to make the survey, then state regulators or NRC 5
regulators or the RSO can go back in and look at the 6
calibration certificate to make sure that that survey 7
instrument used was in calibration and met all the 8
pertinent regulations and requirements. If we don't 9
have that meter used identification, then we can't go 10 any further. So, I think we cover the basis of it.
11 VICE CHAIRMAN METTER: This is Darlene 12 Metter. This is standard language that, I believe, 13 that's in the Reg Guide already.
14 MEMBER MARTIN: This is Melissa. I would 15 agree with that, too. You just want the serial number 16 and model. You can look up the calibration, if needed.
17 CHAIRMAN PALESTRO: Does that answer your 18 concern, Zoubir?
19 MEMBER OUHIB: Somewhat, yes. Thank you.
20 CHAIRMAN PALESTRO: Any other comments, 21 questions, discussion?
22 MEMBER WEIL: This is Laura Weil. I had 23 used the wrong pass code. I apologize. So, I didn't 24 have an open line to get in on the discussion of language 25
40 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 proficiency, and I'd like to make a comment about that, 1
if I might at this point.
2 CHAIRMAN PALESTRO: Yes, please.
3 MEMBER WEIL:
The provision of 4
instructions regarding post-release precautions for 5
folks who have been administered radiopharmaceuticals 6
is no different from the provision of instructions or 7
information about informed consent or any treatment 8
decision, and you can refer back to the Civil Rights 9
Act of 1964 that language assistance is required for 10 any medical discussions. So I don't think we need to 11
-- I mean, Zoubir, I'm very sensitive and support your 12 concern that there may be situations where language 13 proficiency will be an issue, be it languages other 14 than English or for deaf patients or any number of 15 communication issues, but there's an overriding 16 regulation that requires that language assistance be 17 provided, whether it's a small institution or a large 18 institution, and I'm not sure we need to specify 19 specifically for this particular application that there 20 needs to be interpreters made available or translated 21 documents.
22 CHAIRMAN PALESTRO: Thank you, Ms. Weil.
23 Zoubir, any comments?
24 MEMBER OUHIB: None. Thank you.
25
41 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 CHAIRMAN PALESTRO: Any other comments, 1
questions, from the ACMUI? All right. Hearing none, 2
I will now open this session to the public. Is there 3
anyone on the line?
4 OPERATOR: Thank you. We do have a 5
question from Peter Crane. Your line is open.
6 MR. CRANE: Yes, please. Thank you.
7 Appreciate it. In a way, it's a pity that you've waited 8
until the very end to ask for public input because, 9
for example, I had what I thought were some constructive 10 questions on the bylaws and there was no opportunity 11 to raise them. I don't know whether I should do so 12 now. Maybe I should to get them out of the way. Is 13 that all right?
14 CHAIRMAN PALESTRO: That's all right with 15 me. Ms. Holiday?
16 MR. CRANE: Sophie, is that okay by you?
17 MS. HOLIDAY: That's fine.
18 MR. CRANE: Okay. Let me find it quickly.
19 On conflict of interest, Section 4.1, it seems to be 20 a matter of self-reporting sort of in the way that judges 21 of the Supreme Court decide whether to recuse 22 themselves. But suppose it's Member A who thinks 23 Member B shouldn't be taking part in this because of 24 a conflict of interest and Member B doesn't see it that 25
42 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 way? Because my institutional memory is very long, 1
and I can remember when there was a huge flap about 2
nearly 30 years ago because the Office of General 3
Counsel said that a particular person should be recused 4
from acting on a petition which that individual had 5
filed. And the result was that the general counsel 6
was reported to the Office of Government Ethics with 7
a letter saying who's above the general counsel, God, 8
unquote. So I think that ought to be clarified because, 9
you know, some people are just not sensitive to their 10 own conflicts.
11 Secondly, there is, on page six, item 5.4, 12 where it says the ACMUI should consult with the Office 13 of the General Counsel regarding conflicts that arise 14 from the interpretation of the bylaws. After 15 consultation, the ACMUI shall resolve interpretation 16 issues by a majority vote of the current membership 17 of the ACMUI.
18 Now, what that leaves a little bit open 19 is, suppose the general counsel says you can't do it, 20 does that provision mean that the ACMUI can, by majority 21 vote, disregard it? That's ambiguous, I think. I'm 22 not hearing any response to this. Is this simply a 23 one-way street? Hello?
24 CHAIRMAN PALESTRO: Yes, Mr. Crane. This 25
43 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 is Dr. Palestro. In response to your first comment, 1
on conflict of interest, that comes directly from legal.
2 That's the standard verbiage that's used, and that's 3
why it was incorporated.
4 MR. CRANE: Okay. But, you know, that may 5
be so, but maybe OGC should be asked what do you do 6
with a situation? That's a situation that has occurred 7
in which the member does not see a conflict that other 8
people do see. I'm not criticizing. I'm just 9
suggesting that this is an item that you might want 10 to think about and consult with the lawyers about.
11 MS. HOUSEMAN: Hi. This is Esther 12 Houseman, attorney in the Office of the General Counsel.
13 I do want to note for everyone on the meeting that 14 the Office of General Counsel does advise the medical 15 team, as well as the ACMUI itself on its obligations 16 as special government employees to abide by the ethics 17 laws that are cited here. The Office of the General 18 Counsel is also available to answer any legal questions 19 concerning those ethics requirements and also any 20 questions the staff have on the ACMUI bylaws. So the 21 ACMUI and the staff do have legal counsel on these 22 matters.
23 MR. CRANE: Well, I understand that, and, 24 actually, I worked in OGC for 23 years, so I'm fairly 25
44 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 familiar with its responsibilities. My point is can 1
OGC, is OGC the deciding word on what's legal or --
2 I'm mixing the two issues -- or can the ACMUI override 3
and act in contradiction to OGC advice? Is it unclear 4
to anybody but me?
5 MS. HOUSEMAN: I think what you're asking 6
right now is a legal question on which OGC would provide 7
legal advice, and I'm not going to provide a legal 8
analysis in the middle of a meeting of this sort. So, 9
I'm not sure what additional information you want.
10 MR. CRANE: Fair enough. All I'm saying 11 is I think this language leaves it a bit open as to 12 whether ACMUI can override OGC, and I think that these 13 sorts of ambiguities ought to be resolved beyond any 14 dispute before and not after they go into effect.
15 That's all I'm saying. Avoiding problems by foreseeing 16 them.
17 MS. HOLIDAY: Thank you for your comment, 18 Mr. Crane. We'll take that under consideration when 19 the ACMUI, they are planning to look at the bylaws later 20 on in the near future, and so this feeds on what they 21 take into consideration on a future date.
22 MR. CRANE: Thank you. If that's Sophie, 23 thanks, because I think I recognize your voice, right?
24 MS. HOLIDAY: Yes, this is Sophie. Thank 25
45 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 you.
1 MR. CRANE: Okay. Third point on the 2
bylaws, it says that the NRC will -- this is 3.1, NRC 3
will solicit nominations by notice in the Federal 4
Register and by such other means as are approved by 5
the Commission. Evaluation of a candidate shall be 6
by such procedures as are approved by the director of 7
NMSS. It's a little vague as to what that is. It seems 8
to be unlimited discretion to the director of NMSS.
9 Is there any conceivable public interest in keeping 10 confidential the names of people who nominate 11 themselves or are nominated for ACMUI positions? Can 12 anybody think of a reason?
13 CHAIRMAN PALESTRO: I'm sorry, Mr. Crane.
14 This is Dr. Palestro. I don't quite understand.
15 Could you restate your concern?
16 MR. CRANE: Okay. My question is it says 17 procedures to be determined by the director of NMSS.
18 That gives him, seems to give him unlimited discretion 19 to do whatever he wants. And it seems to me that, in 20 an agency that dedicates itself to openness, there ought 21 to be a certain degree of openness as to what those 22 procedures are.
23 For example, some years ago, when the 24 position of patients' rights advocate was filled, I 25
46 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 wrote to the NRC and the person chosen was the director 1
of isotope production at DOE. I wrote to the NRC and 2
asked who were the other candidates. I was not a 3
candidate, incidentally. And I got back a letter 4
saying we can't tell you and we wouldn't tell you even 5
if you filed a FOIA, Freedom of Information Act request 6
for the benefit of anybody who doesn't know that. And 7
I thought, well, I'll test that out, and I did file 8
a FOIA and I got back, no, this is privileged 9
information. And it seems to me there ought to be an 10 open process. We ought to know who's nominated, by 11
- whom, self-nominated, by organizations, by 12 individuals, et cetera, and we ought to know the process 13 by which these decisions are made.
14 MS. HOLIDAY: Hello, Mr. Crane, this is 15 Sophie.
16 MR. CRANE: Yes.
17 MS. HOLIDAY: First, I would like to start 18 off by saying that the scope of this meeting was to 19 discuss the proposed amendment to the bylaws, not 20 necessarily to open up other sections of the bylaws 21 as this is related to the discussion at the ACMUI 22 Subcommittee related to the bylaws presented during 23 the April 2019 meeting. However, I will respond to 24 you regarding the process by which the Director of NMSS 25
47 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 selects individuals. Paired with any HR hiring 1
guidance, we do not disclose that type of information 2
in terms of who has applied and who has supported them 3
-- so on and so forth. Similar to how we do not release 4
that type of information for general NRC staff 5
applications, we would not do the same for our special 6
government employees, i.e., the ACMUI members.
7 MR. CRANE: I see. Well, you know, I can 8
-- I can -- I hear what you're saying, certainly, but 9
I have -- and I didn't appreciate that -- that the --
10 the meeting was intended to be limited to very minor 11 changes in the bylaws. It seems to me that when people 12 nominate themselves for a public position, that there 13 is something to be said for greater openness. That 14 it's different from, you know, applying for a job as 15 a -- as a lawyer or a health physicist and having to 16 be listed in the Federal Register as among the rejected 17 candidates. I do think there is a difference. But 18 this isn't the time to debate that.
19 Okay, well that -- that concludes my --
20 what I have to say about the bylaws. But I do have 21 things to say about the patient release issue. If I 22 may continue. May I continue?
23 CHAIRMAN PALESTRO: Please do, sir.
24 MR. CRANE: Thank you, Dr. Palestro.
25
48 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Okay, I am -- there is a consistent problem with the 1
NRC -- to me, with the NRC rule in that it tends to 2
minimize the risk of internal exposure. And that has 3
been true for many years. And just to give the briefest 4
of background, in 1986, the NRC staff turned down a 5
suggestion that release be based on dose to the likely 6
person and it said that in fact this was too uncertain 7
-- that the calculations were easy, but knowing just 8
who was going to be where for how long was complicated.
9 And it said that patients presented a risk both from 10 external and from internal dose. Which I think was 11 entirely correct.
12 And in 1997, when the NRC changed the rules 13 to adopt a dose-based rule, it did so on the basis of 14 advice from a gentleman now deceased -- a nuclear 15 medicine doctor -- who believed that I-131 was no 16 carcinogenic and that the effect of a nuclear accident 17
-- the radiation effect of a nuclear accident would 18 not be harmful on the public's health but rather might 19 be beneficial. And with that kind of attitude, it is 20 understandable that some oddities came into this rule.
21 And one of them was that internal dose was to be 22 ignored, except for the nursing mother. And that 23 everything was to be based on external dose --
24 calculation of probable external dose.
25
49 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 And, you know, I think there is no -- my 1
own view is that nothing is going to solve this problem 2
without the NRC someday biting the bullet and 3
undertaking a rule change. Now, in the Subcommittee's 4
report, under Other Recommendations, on the last page 5
it says, quote, in the patient's precautions and 6
instructions section, it should be emphasized that the 7
major source of radiation dose to other individuals 8
will be from external exposure from the patient, 9
Reference 1. The Reference 1 referred to is ICRP 94.
10 Now, what ICR -- this is -- now here is the way the 11 American Thyroid Association characterized the ICRP 12 94 in its comments to the NRC last year. The ICRP has 13 estimated the risks for all cancers in children at 0.1 14 to 0.2 percent from an effective I-131 dose of one 15 millisievert, which is the equivalent of 100 millirem.
16 Risks the children include those from external 17 radiation exposure as well as potential ingestion of 18 contamination from excreted or secreted I-131 from 19 treated patients. The ATA currently recommends that, 20 quote, having a treated parent staying in the home is 21 often problematic due to children's needs to be near 22 the treated parent. Special arrangements should be 23 made for children to stay with relatives or friends.
24 Alternatively, the treated parent may stay with 25
50 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 relatives or friends where children or pregnant women 1
are absent.
2 If you go to ICRP 94 it says, the modes 3
of exposure to other people are external exposure, 4
internal exposure due to contamination and 5
environmental pathways. Doses to adults from patients 6
is mainly due to external exposure. Contamination of 7
infants and children with saliva from a patient could 8
result in significant doses for the child's thyroid.
9 It is important to avoid contamination of children 10 or pregnant women. And, I mean it -- why do we -- why 11 does the NRC pay for potassium iodide to be stockpiled 12 around nuclear plants? Why does the government 13 stockpile it against acts of terrorism, if not because 14 there is a risk to the public -- and to children above 15 all -- from internal contamination with I-131? And 16 if we are taught -- if this ICRP estimation quoted by 17 the ATA is correct, that means that the 500 millirems 18 that the NRC allows -- which is five times what the 19 ICRP and NCRP permit -- could mean a dose -- an increase 20 of 1 percent in cancer in the exposed child -- five 21
-- half percent to 1 percent. And I just don't see 22 what the benefit is from this rule that makes that 23 possible. And I don't think that we should have a 24 regulatory guide -- and this is what troubles me about 25
51 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 the ACMUI comment that seems to minimize the 1
significance of internal dose. There's nothing in 2
there about kissing.
3 The -- on page 11 of the ACMUI comments 4
the following appears. Page 13, Section 2.3.1, add 5
hotel to the list of examples of post-treatment lodging 6
the patient may use. Why is this troubling? Because 7
the word may have two distinct meanings. It could mean 8
either it is possible that a patient will go to a hotel, 9
or patients are permitted to go to a hotel. Now, it 10 wasn't that long ago that the NRC put out a regulatory 11 information summary -- 2011 -- saying that it is 12 strongly discouraged that patients go to hotels. So, 13 unless the NRC has changed its mind and no longer thinks 14 that it's strongly discouraged, this ambiguous comment 15 should not be accepted. On the contrary, the Reg Guide 16 ought to reiterate the warning in the RIS.
17 I would like, also, to respond to the --
18 well, okay, under 10 CFR 35.75, if the licensee cannot 19 find that a patient's exposure to others will be under 20 500 millirems, it cannot release the patient. No ifs, 21 ands or buts. The draft regulatory guide makes this 22 point under Section 2.32, Patient Precautions, but 23 because the entire guide is declared to be non-binding, 24 as in compliance with RGs is not required, the reader 25
52 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 may not realize that this is a requirement of the 1
regulation and not a waivable piece of guidance.
2 MR. EINBERG: Dr. Palestro?
3 CHAIRMAN PALESTRO: Yes?
4 MR. EINBERG: Dr. Daibes here would like 5
to make a comment in response to Mr. Crane's comments 6
regarding internal doses.
7 (Simultaneous speaking.)
8 MR. CRANE: By all means.
9 CHAIRMAN PALESTRO: That's fine, thank 10 you.
11 DR. DAIBES: Thank you. Mr. Crane, for 12 the next stage of the update, Phase 2, one component 13 that will be considered is internal contamination and 14 the duration of the contamination. So -- but that's 15 something that we are pursuing and the NRC is very aware 16 of.
17 MR. CRANE: I am very happy to hear that.
18 But then, why, I would ask, is there this comment about 19 stressing that the -- the risk is from external 20 contamination in -- in this stage?
21 (No audible response.)
22 MR. CRANE: I mean ---
23 (Simultaneous speaking.)
24 DR. DAIBES: The highest -- but the highest 25
53 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 risks would be from external. However, we are aware 1
that there is a risk from internal and that's why we're 2
3 MR. CRANE: I am sorry, I am sorry -- it's 4
5 (Simultaneous speaking.)
6 MR. CRANE: -- Peter Crane again.
7 C-R-A-N-E. I mean, why, I would ask, does the -- does 8
this phase of the report -- this is -- this line, for 9
example, under Other Recommendations, it should be 10 emphasized that the major source of radiation dose to 11 other individuals will be from external exposure to 12 the patient. But I can give you lots of chapter and 13 verse on the fact of, yes, the greatest dose to adults 14 is going to be from external radiation. But the 15 greatest danger is going to be to children from internal 16 radiation. And we saw it at Chernobyl -- you've got 17 7,000 kids with childhood thyroid cancer. Childhood 18 in the sense that the exposure came in the first four 19 years of life. And it was generally either from 20 inhalation, or from the milk pathway. And I just don't 21 think we should, at any point, be emphasizing one to 22 the exclusion of the other.
23 You look at ICRP 94 and they're very clear 24 that the -- external, the danger to children -- the 25
54 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 heavy danger to children is from internal. They don't 1
say that it's greater, but they say that it's great.
2 Is that -- am I misstating ICRP 94? Does anybody think 3
I am?
4 (Pause.)
5 MR. EINBERG: So, Dr. Palestro, Chris 6
Einberg here again. I think, in the interest of 7
providing other commenters an opportunity to comment 8
as well, we should focus our comments on phase 1 9
comments. This update to Reg Guide 8.39 focuses on 10 Phase 1. Phase 2, when it gets to, you know, dosimetric 11 cal -- calculations and the methodologies -- but I think 12 for the interest of time, we certainly will be providing 13 the public the opportunity to make comments on Reg Guide 14 8.39 when we publish this later on this summer. And 15 it will go out in the Federal Register for public 16 comment. But at this stage, I think we would like to 17 hear about the phase 1 comments that members of the 18 public have.
19 (Simultaneous speaking.)
20 CHAIRMAN PALESTRO: Thank you, Mr.
21 Einberg.
22 MR. CRANE: Thank you, Chris. I 23 appreciate that. And I don't want to monopolize the 24 phone. So, let me sign off and go back to listening 25
55 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 mode. And thank you Dr. Palestro and members of the 1
Committee for hearing me out.
2 MR. EINBERG: Thank you, Mr. Crane.
3 CHAIRMAN PALESTRO: Thank you, Mr. Crane.
4 Other comments from the public?
5 OPERATOR: Thank you. Our next comment 6
is from Carol Marcus. Your line is open.
7 DR. MARCUS: Thank you very much. I would 8
like to make comments on Table 3. The specifics of 9
column 3, which is examples of recommended duration 10 of interruption of breastfeeding. At the bottom of 11 Table 3, the NRC notes that the recommendations in 12 column 3 are from the Advisory Committee on Medical 13 Use of Isotopes Nursing Mother Guidelines for the 14 Medical Administration of Radioactive Material. And 15 there were some meetings about that previously.
16
- However, of the 18 non-technetium 17 radiopharmaceuticals, nine of them are not what was 18 recommended by the ACMUI Subcommittee.
19 I looked in ICRP 106 to see if the NRC was 20 using that instead, but they are not. And I don't know 21 where some of these numbers come from. For example, 22 for I-131 Hippuran, you know, Pat Zanzonico's 23 calculations -- which are the basis of the Subcommittee 24 report -- recommended -- for 100 millirem dose to the 25
56 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 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 1
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 2
interruption. But NRC recommends complete cessation 3
of breastfeeding for this infant or child. And I don't 4
know where in the world that comes from. Again, for 5
thallium-201 chloride, Zanzonico's calculation is for 6
the 100 millirem dose is interruption for 4.3 days.
7 ICRP 106 has an interruption of 2 days. NRC lists an 8
interruption of 14 days. And I don't know where that 9
comes from. If fluorine-18 labeled -- it doesn't say 10 labeled what -- but let's call it FDG, the ICRP 106 11 recommends no interruption. Zanzonico recommends 4 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> of interruption for 100 millirem, and no 13 interruption for 500 millirem, which is the regulatory 14 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 15 millirem. I don't know where that comes from.
16 And then there are six more that are not 17 in compliance with the calculations in the Subcommittee 18 report. So, my first problem with this table is that 19 it says it comes from the Subcommittee report, but it 20 doesn't. Other comments --
21 CHAIRMAN PALESTRO: Dr. Marcus?
22 DR. MARCUS: Yes?
23 CHAIRMAN PALESTRO: Dr. Marcus, I am sorry 24 to interrupt you. This is Dr. Palestro. Regarding 25
57 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 your comment on Table -- your comments on Table 3, the 1
way this evolved is that the working group and the 2
subcommittee were not exactly in temporal synch on Table 3
- 3. And that recommendations of the subcommittee will 4
in fact be incorporated in Table 3 when it goes out 5
for public comment. Mr. Einberg, correct me if I am 6
wrong on that?
7 MR. EINBERG: No, that is correct. Thank 8
you for that clarification.
9 CHAIRMAN PALESTRO: Thank you. All 10 right, go ahead, Dr. Marcus.
11 DR. MARCUS: Yes, okay, thank you, Chris.
12 So -- so I should ignore column 3 because it is going 13 to be changed? Is that it?
14 CHAIRMAN PALESTRO: That is correct.
15 There are changes that are going to be made and the 16 time to review it is when Phase 1 is out for public 17 comment.
18 DR. MARCUS: Okay. While you are doing 19 things like that, there is no such isotope as 20 gallium-55. So please fix that. Maybe they mean 21 gallium-68. But it just listed gallium-55 labeled, 22 and then not even what it is attached to. And -- and 23 this --
24 CHAIRMAN PALESTRO: So noted.
25
58 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 DR. MARCUS: Okay, as I recall in the last 1
ACMUI meeting when Pat Zanzonico was still on the 2
Committee it was agreed, I think unanimously, by the 3
ACMUI that we should have recommendations for the 500 4
millirem limit, because that's what the regulatory 5
limit is. And then there was some argument about 6
conservatism with 100 millirem. And then it was 7
decided we should have both. But in this document, 8
there is no mention of any of the 500 millirem 9
calculations and recommendations. However, you know, 10 the subcommittee report contains all of the 500 millirem 11 recommendations. And I think that the 500 millirem 12 recommendations belong in this guidance because that's 13 the regulatory limit. There are a lot of conservatism 14 in the calculation of radiation dose to the nursing 15 child. And putting another 500 percent on it like this 16 is not called for. So, I think we should put in the 17 500 millirem recommendation of the ACMUI Subcommittee 18 into this document. As far as --
19 MS. HOLIDAY: Dr. Marcus? Dr. Marcus, 20 this is Sophie.
21 DR. MARCUS: Hello.
22 MS. HOLIDAY: Hello. So, if I could just 23 add on to what Dr. Palestro and Mr. Einberg already 24 stated, you know, it was highlighted at the bottom of 25
59 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 page 2 -- going over to page 3 -- of the Subcommittee's 1
report that the table should be updated to reflect the 2
recommendations in the ACMUI January 31st, 2019 3
Subcommittee report. And if you look at the draft 4
proposed Reg Guide that is attached to this document, 5
Reference 6 is where it is referencing the subcommittee 6
report that was used. And it states there that from 7
the 2018 subcommittee report -- so by virtue of that 8
-- I am raising that point to just simply say that the 9
tables will be updated as appropriate when it goes out 10 for public comment later on this summer. So, realize 11 that it does not reflect the cessation periods or the 12 500 millirem -- or any of that information that is 13 contained in the January 2019 Subcommittee report.
14 But that's because that's not what was used when this 15 document was routed to the ACMUI for its review.
16 DR. MARCUS: But Sophie, are you going to 17 include 500 millirem values?
18 MS. HOLIDAY: I am not a part of that 19 working group, so I can't speak on that. I am simply 20 stating the fact that the ACMUI's report from January 21 of this year will be referenced when the reg guide goes 22 out for public comment. So I -- again, I can't speak 23 whether or not the 500 millirem will be used or not.
24 But any information that the subcommittee provided 25
60 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433
-- which was endorsed unanimously by the Committee --
1 will be used by the working group as it considers the 2
ACMUI's comments during this meeting, as well as any 3
other comments that they may have received internally 4
before it goes out for public comment.
5 DR. MARCUS: Okay. Well, I encourage the 6
ACMUI to recommend to the NRC that the 500 millirem 7
values be included in this document. I really don't 8
want to start a big discussion on what Peter Crane is 9
saying. We could go on forever. We have already gone 10 on for about 25 years. But when you talk about saliva 11 being a source of internal contamination to babies and 12 young children, you know, I think if adults are French 13 kissing babies and young children, there is a lot bigger 14 problem around than radiation. I think this is really 15 overly exaggerated.
16 But, the authorized users take into 17 consideration if there are babies and young children 18 around -- and I don't see that there is any problem 19 with any of it. You know, Peter doesn't have any data 20 showing some incredible increase in thyroid cancer in 21 children whose family members were treated for thyroid 22 cancer. You know -- unless it's a genetic basis. And 23 then it isn't from I-131, it's just from a genetic 24 mutation. So I don't think that this saliva issue is 25
61 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 a really meaningful one.
1 As far as cremating bodies, you can have 2
a service for someone who has died, and you can hold 3
the corpse in the morgue for a month, or weeks, or 4
whatever you need. And you can incinerate it 5
subsequently. There's certainly very safe ways of 6
doing these things. And I don't think that this has 7
led to any bad problems, either. You can have some 8
contamination, but that doesn't mean it's a public 9
health and safety hazard. It doesn't mean that the 10 radiation dose is dangerous. Just a few atoms around 11 doesn't really make it dangerous at all -- which is 12 why the NRC never made it illegal to put mildly 13 radio-contaminated patient waste in a garbage dump.
14 It's the people who regulate garbage dumps that tried 15 to keep it out. And finally they're getting used to 16 the idea that these tiny levels are harmless and not 17 of any concern, and they're letting it go. It's taken 18 them about 30, 40 years, but they're finally getting 19 there.
20 Okay, I think that's the end of my comments.
21 Thank you, Dr. Palestro.
22 CHAIRMAN PALESTRO: Thank you, Dr. Marcus.
23 Any other comments from the public?
24 OPERATOR: We do have one more comment.
25
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(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Ralph Lieto, your line is open.
1 MR. LIETO: Yes, can you hear me?
2 CHAIRMAN PALESTRO: Yes.
3 MR. LIETO: I have two questions. One is, 4
could staff or --
5 CHAIRMAN PALESTRO: I am sorry, could you 6
please -- hello? Please state your name?
7 MR. LIETO: This is Ralph Lieto. I am a 8
medical physicist. And I have two questions. One 9
relates to the reg guide and its relationship to 10 Appendix U of NUREG-1556, Volume 9. Is it going to 11 replace the Appendix U in its entirety? Or is there 12 going to be some kind of a coordination between the 13 two that's going to have to be done in the future?
14 MS. DIMMICK: This is Lisa Dimmick, 15 Medical Radiation Safety Team Leader. So Reg Guide 16 8.39 will replace Appendix U so that there is only 17 information -- will be in one location. So that we 18 don't have a situation where we have the guidance in 19 two different locations that could potentially be not 20 in synch with the other.
21 MR. LIETO: Very good, excellent, thank 22 you. My last question has to do with when this reg 23 guide goes out for public comment. Will that be after 24 Phase 2? Or is it going to go out after Phase 1, get 25
63 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 comments, and then go back out again after Phase 2?
1 MS. DIMMICK: So this is Lisa Dimmick 2
again. So the plan is to publish Phase 1 for public 3
comment this summer. And the plan is to issue Phase 4
1 -- the Phase 1 revision by next April. And while 5
this is happening, in the background we will begin the 6
Phase 2 update with a contractor. And then, once the 7
Phase 2 update is ready for public comment, we will 8
post -- we will publish Reg Guide Phase 2 Update for 9
public comments as well.
10 MR. LIETO: Just for clarification, then, 11 the Phase 2 will go out after you've received all the 12 comments from Phase 1, correct?
13 MS. DIMMICK: And actually probably after 14 we've published a Phase 1 revision. Correct.
15 MR. LIETO: All right, thank you.
16 CHAIRMAN PALESTRO: Any other comments or 17 questions from the public?
18 OPERATOR: At this time we have no 19 questions from the public.
20 CHAIRMAN PALESTRO: Any other comments or 21 questions from ACMUI?
22 (No audible response.)
23 CHAIRMAN PALESTRO:
Any
- comments, 24 questions, additional information from Ms. Holiday, 25
64 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 Ms. Jamerson, Ms. Dimmick or Mr. Einberg?
1 MR. EINBERG: Nothing here. This is Chris 2
Einberg.
3 CHAIRMAN PALESTRO: At this point, then, 4
I believe we can adjourn the meeting.
5 MS. HOLIDAY: No, Dr. Palestro.
6 (Laughter.)
7 CHAIRMAN PALESTRO: Yes?
8 MS. HOLIDAY: Is there a motion to approve 9
the Subcommittee's report and its recommendations 10 herein?
11 CHAIRMAN PALESTRO: I'm sorry.
12 MEMBER WOLKOV: So moved. This is Harvey 13 Wolkov.
14 CHAIRMAN PALESTRO: Do I hear a second?
15 MEMBER MARTIN: This is Melissa Martin, 16 I will second.
17 CHAIRMAN PALESTRO: All right, any further 18 discussion?
19 (No audible response.)
20 CHAIRMAN PALESTRO: All in favor?
21 (Chorus of aye.)
22 CHAIRMAN PALESTRO: Any opposed?
23 (No audible response.)
24 CHAIRMAN PALESTRO: Any abstentions?
25
65 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 (No audible response.)
1 CHAIRMAN PALESTRO: All right, motion is 2
passed unanimously. Now, Ms. Holiday, can we adjourn 3
the meeting?
4 MS. HOLIDAY: Almost.
5 (Laughter.)
6 MS. HOLIDAY: A very quick summary, since 7
we couldn't hear Ms. Weil earlier, I just need to get 8
on the record whether or not she endorsed the ACMUI 9
Bylaw amendments?
10 (Pause.)
11 MS. HOLIDAY: Ms. Weil?
12 MEMBER WEIL: Yes, I did.
13 MS. HOLIDAY: Thank you. Okay, then for 14 the record we have that the ACMUI passed a motion where 15 Dr. Wolkov made the motion, Dr. Metter seconded to 16 approve the amended bylaws. This was passed with one 17 abstention by Dr. Palestro. The second motion was to 18 approve the ACMUI draft subcommittee report for the 19 Draft Proposed Reg Guide 8.39 Revision 1, Phase 1.
20 The motion was made by Dr. Harvey Wolkov, seconded by 21 Ms. Melissa Martin. This was unanimously endorsed by 22 the committee. Are there any questions, comments, 23 concerns? Or did I misstate the facts?
24 (No audible response.)
25
66 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 MS. HOLIDAY: Hearing none, I will capture 1
that and hold to the recommendations from the committee 2
for this meeting.
3 CHAIRMAN PALESTRO: All right, thank you.
4 Any other discussion? Any other matters of business 5
that need to be addressed?
6 MS. JAMERSON: I have one other thing.
7 This is Kellee Jamerson, Dr. Palestro.
8 CHAIRMAN PALESTRO: Yes.
9 MS. JAMERSON: I would like to announce 10 that the fall meeting of the ACMUI will be September 11 10th and 11th, 2019.
12 CHAIRMAN PALESTRO: Thank you. And as I 13 had remembered emailing you about this, just to confirm 14 that it is in fact the second choice, but for reasons 15 of scheduling, that is now the definitive meeting date.
16 Am I correct?
17 MS. JAMERSON: That is correct.
18 CHAIRMAN PALESTRO: All right. Any other 19 business?
20 MR. EINBERG: Yes, and this is Chris 21 Einberg. And I just wanted to thank the subcommittee 22 and the full committee on behalf of the NRC for their 23 hard work on this topic. I know you have put a lot 24 of effort into this and that it's a topic that has a 25
67 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 lot of interest -- public interest -- and I would like 1
to thank the public commenters, also, for their interest 2
and their comments. And you will have additional 3
opportunities to provide input on this topic. So, 4
thank you everybody.
5 CHAIRMAN PALESTRO: Any other business?
6 Any other comments?
7 (Pause.)
8 MR. EINBERG: Nothing here at the NRC.
9 CHAIRMAN PALESTRO: All right. Anything 10 from the ACMUI?
11 (No audible response.)
12 CHAIRMAN PALESTRO: All right, then --
13 meeting is adjourned. Thank you.
14 (Whereupon, the above-entitled matter went 15 off the record at 3:32 p.m.)
16 17 18 19 20 21 22 23 24 25
ef!j> CAROLS. MARCUS, Ph.D., M.D.
MAILING ADDRESS: 1877 COMSTOCK AVENUE LOS ANGELES, CA 90025-50 14 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:
PHONE:
FAX:
E-MAIL:
(3 10) 277-4541 (3 10) 552-0028 csmarcus@ucla.edu 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 1 o-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+
Abstract-Medical licensees are required to comply with U.S.
Nuclear Regulatory Commission (NRC) regulations pertaining to the release of patients administered radioactive material.
However, use of the associated NRC guidance expressed in NUREG-1556, Volume 9, is completely optional and has been shown to be overly conservative. Rigid adherence to the guidance recommendations has placed an undue burden on nuclear medicine therapy patients and their families, as well as licensees responsible for ensuring compliance with NRC re-quirements. More realistic guidance has been published by other responsible professional societies and will be presented in this work. These more realistic calculations allow for higher releasable activity levels than the widely adopted NUREG levels, particularly for thyroid cancer patients. The guidance-suggested releasable activity limit is similar to our calcula-tional result for hyperthyroid patients, 2.1 GBq (57 mCi) 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 mCi) using the regulatory definition of the total effective dose equivalent (TEDE). Higher limits are both possible and rea-sonable, if the permissible extra-regulatory definition of the TEDE is used in which the effective dose equivalent (EDE),
rather than the deep-dose equivalent (DDE), is determined.
We maintain that professionals evaluating compliance with the NRC requirements for patient release, pursuant to 10 CFR 35.75, should use the procedures presented here and not rely automatically on the NUREG.
Health Phys. 93(6):667-677; 2007 Key words: nuclear medicine; dosimetry; safety standards; medical radiation INTRODUCTION U.S. N ucLEAR Regulatory Commission (NRC) regula-tions for the release of patients administered radioactive material, pursuant to 10 CFR 35.75, authorize patient release according to a dose-based limit, i.e., the dose to
- Nuclear Physics Enterprises, Marlton, NJ; 1 UCLA, Los Angeles, CA; t Vanderbilt University, Nashville, TN.
For correspondence contact: Michael G. Stabin, Department of Radiology and Radiological Sciences, Vanderbilt University, 1161 21 st Avenue South, Nashville, TN 37232-2675, or email at michael.g.stabin @
vanderbilt.edu.
(Manuscript accepted 4 May 2007) 0017-9078/07 /0 Copyright © 2007 Health Physics Society 667 other individuals exposed to the patient (U.S. NRC 1997). The dose-based limit, which replaced the activity-or dose-rate-based release limit, < 1,110 MBq (30 mCi) or < 0.05 mSv h-1 (5 mrem h-1) at 1 min 1997, better expresses the NRC's primary concern for the public's health and safety and makes good scientific sense. A licensee may release patients, regardless of administered activity, if it can be demonstrated that the total effective dose equivalent (TEDE) to another individual from exposure to a released patient is not likely to exceed 5 mSv (0.5 rem).
Individuals exposed to released radionuclide therapy patients can potentially receive radiation doses by two distinct sources: external exposure and internal intake.
The TEDE concept makes it possible to combine these dose components in assessing the overall risk to the health of an individual. The TEDE, pursuant to 10 CFR 20.1003, is equal to the sum of the deep-dose equivalent (DDE), due to external exposure, and the committed effective dose equivalent (CEDE), due to internal intake.
U.S. NRC regulations, pursuant to 10 CFR 20.1101,
require that applicants and licensees develop, document, and implement operating policies and procedures as part of an overall radiation protection program that will ensure compliance and the security and safe use of licensed materials. These radiation protection policies and procedures for their implementation are neither detailed in the regulations nor required to be submitted as part of the license application (Siegel 2004 ). Some practitioners have developed their own radiation protec-tion programs, but most have relied on model procedures published by the NRC in guidance documents. There is no question that licensees must comply with NRC regulations, but doing so by adopting regulatory guid-ance is not necessary. The NRC will accept alternative approaches, but a large number of licensees know that use and adoption of NRC-proposed guidance will clearly provide an acceptable approach to the NRC and many licensees are not able to devote the time or resources
668 Health Physics necessary to establish their own alternative implementing procedures and policies. Although guidance documents do not contain regulatory requirements, if licensees commit to following these procedures they will become conditions of their licenses.
We do not take issue here with the NRC regulations related to patient release. We do, however, note that the associated NRC guidance for licensee compliance with 10 CFR 35.75 as promulgated in NUREG-1556, Vol. 9, Rev.I, Appendix U, Model Procedure for Release of Patients or Human Research Subjects Administered Ra-dioactive Materials, has been shown to be overly con-servative and places a high burden on nuclear medicine therapy patients and their families, as well as on licensees who adopt the guidance. A series of published studies and guidelines issued by other responsible professional societies has provided guidance in compliance with the applicable NRC requirements at a clearly lower burden to all parties involved. Substitution of these approaches for those in the NUREG will provide a clear benefit to patients and their families, and will make the job of licensees easier as well. We will confine our arguments to the release of patients who have received oral Na 1311 for the treatment of thyroid cancer or hyperthyroidism, but note that the rationale of the arguments applies also to other radionuclide therapy agents.
The purpose of this work is to critically evaluate the compliance-implementing procedures as proposed in the NUREG and to suggest alternative compliance methods.
We examine the guidance methods to assess the external dose component, the internal dose component, and thus the TEDE, and by so doing, demonstrate that the guid-ance procedures are overly conservative and introduce an unnecessary regulatory burden not codified in NRC requirements. We propose alternative procedures to en-able licensee compliance with 10 CFR 35.75, and we recommend that all licensees use these procedures in-stead of automatic reliance on the NRC guidance docu-ments.
PATIENT RELEASE BASED ON NRC GUIDANCE The external dose component (DDE)
NUREG-1556, Vol. 9, Rev.I, Appendix U (U.S.
NRC 2005) provides model procedures for calculating the external dose to others from exposure to released patients. According to the NUREG, compliance with the NRC regulatory dose limit requirement can be demon-strated by licensees by either: (1) using provided default tables for activity or dose rate at I m for a variety of radionuclides; or (2) performing a patient-specific dose calculation.
December 2007, Volume 93, Number 6 Use of the "default" values. The "default" patient release values are based on integration of external dose to a maximally exposed individual to total decay after release of patients receiving radioactive material. Two very conservative assumptions are involved in modeling this dose in NUREG-1556, Vol. 9: 1) that the activity in the patient can be represented as an unshielded point source; and 2) that removal of activity from the patient is only due to physical decay of the radionuclide involved.
This approach fails to consider the distributed nature of most radiopharmaceutical agents and does not account for the often significant biological elimination that di-minishes activity levels in the patient (and thus dose rates outside the patient) over time. This method is highly over-conservative for 1311 sodium iodide. Therapy pa-tients receiving 1311 do not retain 100% of the radioac-tivity for the physical half-life of the radionuclide (8 d);
rather, a significant portion of the administered activity is not taken up by the thyroid gland and is rapidly excreted.
For 1311, the 5 mSv dose limit is predicted in the NUREG to be achieved with an administered activity of 1,221 MBq (33 mCi), or a dose rate of 0.07 mSv h-1 (7 mrem h - i) at 1 m, for both thyroid cancer and hyperthyroid patients, representing a value of 4.10 X 10- 3 mSv MBq-1 (15.2 mrem mCi-1) (this dose per unit administered activity is an order of magnitude higher than if a patient-specific dose calculation is performed; compare to values given below based on eqn 1 ). In essence, use of NRC "default values" for Na 1311 represents a return to the historical "30-mCi rule" and is quite regressive, espe-cially since there is no credible origin or scientific basis for this rule (Siegel 2000). Further, empirical data re-cently obtained by measurement of the dose received by family members of thyroid cancer patients receiving 1311 (Grigsby et al. 2000) support and confirm that the use of a 1,221 MBq activity limit for all patients is overly conservative.
Clearly, use of only simple knowledge of adminis-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-tain doses to others that are as low as is reasonably achievable (ALARA) that would have to be in place for an extremely long time. Rational analysis suggests that the use of overly simplistic "point-source-radioactive-decay-only" models will significantly overestimate doses to others from Na 131I (and many other radiopharmaceu-ticals), and this has been confirmed by actual measure-ments (Grigsby et al. 2000). Thus, there is no question that -patient-specific dose calculations that would permit the release of patients from radioactive isolation with more than 1,221 MBq must be performed for 1311 therapy patients to provide a more complete and appropriate
Release of patients treated with 13 11 e J. A. SIEGEL ET AL.
669 estimation of dose (and patient release instructions) to individuals likely to be exposed to the patient.
Use of the patient-specific dose calculation. The "patient-specific" dose equation provided in the NUREG that can be used to estimate the likely external exposure to total decay, i.e., DDE at infinite time or DDE(co) in mSv (mrem), to an individual from a released radionu-clide therapy patient receiving oral Na131I for thyroid cancer and hyperthyroidism is:
DDE(co) = [34.6fQ0]/(100 cm)2{£1Tp(0.8)
[) _ e - 0.693(TNv)/Tp] + e - 0.693(TNv)/Tp E2F I T1eff where:
34.6 = conversion factor of 24 h d-1 times total integration of decay (1.44 );
r = exposure rate constant for an unshielded point source, for 1311 = 0.595 mSv cm2 MBq-1 h-1 (2,200 mR cm2 mCi-1 h-1);
Q0 = administered activity in MBq (mCi);
£ 1 = occupancy factor for first 8-h non-void pe-riod = 0.75; TP = physical half-life in days = 8.04 for 1311; 0.8 = an assumed factor indicating that 80% of the administered activity is removed from the body only by the physical half-life of 1311 during the non-void period; TNv = non-void period in days = 0.33 (8 h);
£ 2 = occupancy factor from 8 h to total decay =
0.25; F1 = extrathyroidal uptake fraction = 0.20 in hy-perthyroid patients = 0.95 in thyroid cancer patients; T1err = effective half-life of extrathyroidal compo-nent = 0.32 d in hyperthyroid patients =
0.32 d in thyroid cancer patients; F2 = thyroidal uptake fraction = 0.80 in hyperthy-roid patients = 0.05 in thyroid cancer pa-tients; and T2err = effective half-life of thyroidal component =
5.2 d in hyperthyroid patients = 7.3 d in thyroid cancer patients.
Eqn (I) represents the dose to an individual likely to receive the highest dose from exposure to released 1311 patients as it is taken to be the dose to total decay. The equation contains 3 components: (I) a non-void period for the first 8 h after administration; (2) an extrathyroidal component from 8 h to total decay; and (3) a thyroidal component from 8 h to total decay. Eqn ( 1) can be solved for the external dose component per unit administered activity, Q0*
In the case of thyroid cancer patients:
- DDE(co)/Q0 (mSv MBq-1) = 2.06 X 10-3 {0.135 +
0.0739 + 0.0887} = 6.12 X 10-4 mSv MBq-1; and
- DDE(co)/Q0 (mrem mCi-1) = 7.61 {0.135 + 0.0739 +
0.0887} = 2.27 mrem mci-1, where the percentages of the total dose due to the non-void, extrathyroidal, and thyroidal components are 45%, 25%, and 30%, respectively.
In the case of hyperthyroid patients:
- 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 +
1.01} = 8.84 mrem mCi-1, where the percentages of the total dose due to the non-void, extrathyroidal, and thyroidal components are 12 %, 1 %, and 87%, respectively.
These 2 equations can be solved for the maximum allowable administered activities for authorizing patient release based on the 5 mSv regulatory dose limit. Eqn (I) can also be solved for the maximum allowable dose rates at 1 m, given by fQJ(] 00 emf These values are shown in Table 1.
These activity limits, as well as those in later sections, can be applied to all patient releases. According to the NUREG, the parameter values in eqn ( 1) are "acceptable" values (e.g., the occupancy factors and the representative uptake fractions and effective half-lives) to be used in class-specific dose calculations for patients with thyroid cancer and hyperthyroidism. Thus, individ-ual dose calculations need not be performed on a case-by-case basis for these patients, unless a specific pa-tient's situation warrants the use of parameter values different from those used in eqn ( 1 ). For example, the licensee may select more realistic uptake fraction and effective half-life values from the scientific literature or choose to measure the biokinetics in individual patients, measure the dose rate and/or use an occupancy factor
<0.25, if appropriate. In these cases, as stated in the NUREG, a patient-specific calculation would be required Table 1. Maximum activities and dose rates at l m for authorizing patient release for thyroid cancer and hyperthyroid patients (based on eqn 1).
Thyroid cancer Hyperthyroidism Activity in GBq (mCi) 8.2 (221) 2.1 (57)
Dose rate in mSv h-1 (mrem h" 1) 0.49 (49) 0.12 (12)
670 Health Physics in place of the use of the class-specific values given in Table 1.
This class-specific approach is highly conservative and unnecessarily restrictive. Several assumptions were made by the NRC in assigning values to the parameters used in eqn (I). The two biggest contributors to the conservatism are: I) use of the exposure rate constant, which is an unshielded point source value; and 2) use of an 8-h non-void period and associated 0.75 occupancy factor. Since a patient is not adequately represented as an unshielded point source (particularly with respect to their extrathyroidal activity distribution), an exposure rate constant accounting for radionuclide distribution and patient attenuation must be used since without such considerations unrealistic and unnecessarily conservative results will be obtained, perhaps as high as a factor of 2 (Sparks et al. 1998; Siegel et al. 2002a).
During the first 8 h after administration, 80% of the 1311 administered is assumed to be removed from the body at a rate determined only by its physical half-life to account for the time of the 1311 to be absorbed from the stomach to the blood and the holdup of iodine in the urine while in the bladder. The remaining 20% of the administered activity must be associated with some unknown physiological mechanism as it is unaccounted for during this initial 8-h non-void period. It is important to note that there are no scientific data to support the notion of a "non-void" period of any significant length.
Patients are hydrated before the administration of Na 1311 and are strongly urged to drink plenty of fluids for several days afterwards. Patients often void before even leaving the Nuclear Medicine service, and frequently thereafter. Na1311 is absorbed within I0-15 min after an oral administration (Loevinger et al. 1988) and upon reaching the blood is immediately filtered out by the kidneys; with large fluid intakes, the patient may typically void hourly.
A recent international controlled study of iodine biokinetics in radioiodine therapy of thyroid cancer (Hanscheid et al. 2006) indicated that the whole body retention of radioiodine was generally described by a biexponential activity-time curve, with no significant activity excretion time delay, based on whole-body probe and gamma camera scanning measurements. The total body residence times obtained (mean value of 24.1 h in hypothyroid patients) were in good agreement with the value of 23.2 h, a value that would be calculated based on the NRC guidance representative values for a 2-component total body retention curve involving extra-thyroidal and thyroidal components. In addition, this latter total body residence time of 23.2 h with an associated activity excretion of 48% at 8 h, correspond-ing to generally. hypothyroid patients, is in excellent agreement with that reported in MIRD Dose Estimate December 2007, Volume 93, Number 6 Report No. 5 (Berman et al. 1975) for the case of a maximum thyroid uptake of 5% in euthyroid patients. It should be noted that mean whole-body residence times have been observed to be longer for hypothyroid (24.1 h) than euthyroid (17.3 h) patients (Hanscheid et al. 2006).
Thus, established models and recent data indicate that approximately 50% of the administered activity is ex-creted from the body during the NRC's presumed non-void period in the case of a thyroid cancer patient.
The inclusion of the non-void component in eqn (I) has a profound effect on the estimated dose an individual is likely to receive, particularly from released thyroid cancer patients. As demonstrated above, 45% of the total dose is attributable to the non-void component for these patients (Siegel 1999); thus, its inclusion represents an additional factor of 2 conservatism as the 8.2 GBq activity limit in Table I is likely to result in a dose of only 2.75 mSv, equal to 3.35 X 10- 4 mSv MBq-1 (1.24 rnrem mCi-1). In support of this claim, a regulatory analysis on the revised IO CFR 35.75 completed in 1996 (Schneider and McGuire 1996) made no mention of an initial non-void period and estimated, for example, that based on use of only a two-component model consisting of thyroidal and extrathyroidal biokinetics, the maximum likely dose to total decay to individuals exposed to a thyroid cancer patient would be 2.48 mSv from a 7.4 GBq activity administration, equal to 3.35 X 10-4 mSv MBq-1 (1.24 mrem mCi-1). For hyperthyroid patients, inclusion of the non-void component has minimal effect (as demonstrated above, the percent of the total calcu-lated dose attributable to this initial non-void period is 12%) and is really not necessary as it is mathematically redundant; approximately 14% of the administered ac-tivity is excreted from the body at 8 h based on the NUREG representative uptake fractions and effective half-lives.
Direct measurements are the best way to obtain the dose any individual is likely to receive based on the reality of daily life. Dosimeter measurements obtained in 65 household members of 30 patients who received outpatient 1311 therapy for thyroid carcinoma indicated that the mea-sured radiation dose was on average a factor of IO lower than the radiation dose predicted based on eqn (I) (Grigsby et al. 2000). These empirical data are further evidence demonstrating the overly conservative nature of the dose calculation as implemented through use of eqn (I).
The internal dose component (CEDE)
NRC guidance in NUREG-1556, Vol. 9, Rev.l, Appendix U uses the following equation for the likely internal dose component (i.e., CEDE) for individuals who may come in contact with a released patient who received oral Na 1311:
Release of patients treated with 1311
671
- CEDE (Sv) = Q0 (MBq) X 10- 5 X 1.43 X 10- 2 Sv MBq-1; and
- CEDE (rem) = Q0 (mCi) X w-s X 53 rem mci-1, (2) where I 0-5 is the NRC assumed fractional intake and 1.43 X w-2 Sv MBq-1 (53 rem mCi-1) is the dose conversion factor to convert an intake of 131I in MBq (mCi) to a CEDE in Sv (rem). It is obvious from this equation that the predicted internal dose component per unit activity will always be a constant value of 1.43 X J0- 4 mSv MBq-1 (0.53 mrem mCi-1). Thus, unlike the guidance for the external dose component, which permits variability and thus patient-specificity, only a fixed or case-specific internal dose component is considered for both thyroid cancer and hyperthyroid patients.
A common "rule of thumb" is to assume that no more than I millionth of the activity being handled will become an intake to an individual working with the material. This heuristic was developed for cases of worker intakes during normal workplace operations, worker intakes from accidental exposures, and public intakes from accidental airborne releases from a facility (Brodsky 1980), but it does not specifically apply for cases of intake by an individual exposed to a patient.
Admittedly, there are limited data for thyroid uptakes in family members exposed to Na 131I patients. Two studies performed in the 1970' s (Buchan and Brindle 1970; Jacobson et al. 1978) on the intakes of individuals exposed to patients administered 131I indicated that in-takes were generally on the order of I millionth of the activity administered to the patient and that internal doses were far below external doses. Based on these two studies, NUREG-1492 (Schneider and McGuire 1996),
the regulatory analysis for JO CFR 35.75, concluded that internal doses are likely to be much smaller than external doses and much smaller than the public dose limit, and therefore did not consider internal exposures in their analyses. In addition, the National Council on Radiation Protection and Measurements (NCRP) addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. 11, Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients and concluded that "a contamination incident that could lead to a significant intake of radio-active material is very unlikely."
As given in eqn (2), NRC guidance recommends use of 1 o-s for the assumed fractional intake. According to NRC, this value was chosen in order to account for the most highly exposed individual and to add a degree of conservatism to the calculation. However, no such "highly exposed" individual has ever been found, and no documentation substantiates that this "factor of IO" conservative approach is advisable, necessary, or accu-rate.
The total effective dose equivalent (TEDE)
Summing the values of DDE(oo) per unit administered activity, based on the patient-specific dose calculation given by eqn (1) and the CEDE per unit administered activity values based on eqn (2), the TEDE per unit administered activity is given as follows.
In the case of thyroid cancer patients:
- TEDEJQ0 (mSv MBq-1) = 6.12 X 10- 4 mSv MBq-1 +
1.43 X I0- 4 mSv MBq-1; and
- TEDE/Q0 (mrem mCi-1) = 2.27 mrem mCi-1 + 0.53 mrem mCi-1*
In the case of hyperthyroid patients:
- TEDEJQ0 (mSv MBq-1) = 2.39 X 10- 3 mSv MBq-1 +
1.43 X I0- 4 mSv MBq-1; and
- TEDE/Q0 (mrem mCi-1) = 8.84 mrem mCi-1 + 0.53 mrem mCi-1*
Using this approach, the internal dose component will always be 23% (l.43/6.12) and 6% (1.43/23.9) of the external dose component for thyroid cancer and hyper-thyroid patients, respectively, irrespective of the admin-istered activity.
NRC guidance states that when the internal dose component is less than 10% of the external component, it does not need to be considered (U.S. NRC 2005). Thus, internal contamination will never have to be considered for hyperthyroid patients whereas the summation of internal and external dose components will always be required for thyroid cancer patients if a patient-specific dose calculation is performed. In the case of the NUREG default-value approach, the TEDE is assumed to be equal to the external dose "because the dose from intake by other individuals is expected to be small." The values in Table 1 are therefore valid for the release of hyperthyroid patients, e.g., the maximum releasable activity is 2.1 GBq. However, the Table 1 values cannot be used for thyroid cancer patients, e.g., the maximum releasable activity of 8.2 GBq is not applicable. The dose calcula-tion approach will always result in a maximum releasable activity for thyroid cancer patients of 6.6 GBq (179 mCi)
(the constraint that the CEDE is always 23% of the DDE(oo), which forces a DDE of approximately 4.05 mSv and an associated CEDE of 0.95 mSv to be in compliance with the 5 mSv TEDE limit). Although not applicable, if the same logic is followed, but this time with the constraint that the CEDE always be 6% of the
672 Health Physics DDE(oo), the maximum releasable activity for hyperthy-roid patients would be 2.0 GBq (53 mCi).
The advice requiring inclusion/exclusion of the internal dose component in the NUREG for the TEDE calculation has no basis in regulatory requirements; in fact, it adds an "extra-regulatory" burden on licensees. It is also incorrect as it may violate NRC regulations. For example, Example 4 in the NUREG uses the "default" value external dose of 5 mSv for a 1,221 MBq 1311 administration and determines a CEDE of* 0.17 mSv.
Since the internal dose is only 3% of the external dose, it is stated that the CEDE determinations are never neces-sary in the TEDE calculation if the default-value ap-proach is taken; however, the TEDE will. exceed the regulatory limit of 5 mSv (5 mSv + 0.17 mSv = 5.17 mSv) and the licensee would be in violation of NRC regulations.
The maximum activity release values given in this section are based on the assumption that the "patient-specific" dose calculation approach (use of eqns 1 and 2) used for determination of the TEDE is accurate. As described above, the NUREG approach is, at the very least, unjustifiably conservative, potentially by a factor as high as 4 in the case of thyroid cancer patients. The conservatism is due mainly to the assumption of an essentially non-existent non-void period, the use of an exposure rate constant representing an unshielded point source for the extrathyroidal activity biodistribution, and the use of an intake value of 10- 5* The more appropriate maximum fractional intake value of 1 o-6 should be used since this level is seldom, if ever, exceeded by the reported data. This "seldom exceeded" criterion was used in the NUREG in Footnote I of Table U.6 for selection of the thyroid uptake fraction in the hyperthyroidism case. The impact of these assumptions in the case of hyperthyroid patient release is much less significant since we have shown that the majority of the calculated total dose to others (i.e., 87%) is due to the thyroidal component.
When data are not available, use of conservative calculations may be reasonable, as they can identify or rule out a potential problem and may be used to add a margin of safety to procedures that do not have well-defined outcomes. However, when data are available, as they are in the case of patients treated with Na131I for thyroid cancer and hyperthyroidism, the overuse of conservatism does not serve the goal of radiation protec-tion practice, which is to provide optimization of radia-tion doses (economic, social, and other factors consid-ered) within a system of dose limitation. Massive conservatism violates the principle of optimization and places an undue burden on those enforcing dose limits and on those subject to the limitations; in this case, December 2007, Volume 93, Number 6 radionuclide therapy patients and their families. Impor-tantly, the regulations, pursuant to 10 CFR 35.75(a), do not require any calculational conservatism, let alone that promulgated in the NUREG; licensees must only dem-onstrate that the TEDE to any other individual from exposure to a released patient is not likely to exceed 5 mSv. Maintaining this calculated dose to others ALARA is the purpose of the required instructions, pursuant to 10 CFR 35.75(b). In point of fact, a patient receiving 1,221 MBq of 1311 for hyperthyroidism can potentially expose individuals to a larger radiation dose than a patient receiving 7.4 GBq of 1311 for thyroid cancer if appropriate instructions are not provided, due to the much longer retention of a significant fraction of 1311 in the body in the former case.
Therefore, we recommend that licensees perform more realistic calculations (e.g., use of an appropriate shielding factor for the exposure rate constant, no non-void period, use of a fractional intake value of I o-6) and not simply automatically adhere to the approaches pro-vided in the NUREG in order to permit realistic release limits and patient instructions that still are clearly in compliance with NRC regulations.
PATIENT RELEASE BASED ON SNM/ACNP GUIDANCE One alternative approach to that given in NRC guidance that can be used for patient release has been proposed in a Society of Nuclear Medicine and American College of Nuclear Physicians (SNM/ACNP) guidebook (Siegel 2004). Using eqn (1), but substituting an expo-sure rate constant equal to 0.459 mSv cm2 MBq-1 h-1 (1,700 mR cm2 mCi - 1 h-1) (Carey et al. 1995), a non-void period of I h, and an occupancy factor of 0.25 during this period, the maximum allowable activities and dose rates for authorizing patient release are given in Table 2.
In our opinion, licensees can quite justifiably use the values in Table 2 as their basis for patient release. The maximum activity and dose rate values are higher in Table 2 than in Table 1 due to the use of less conservative and more realistic parameter values. It should be noted that this method assumes that the TEDE is equal to the external dose. This is because the internal dose was Table 2. Maximum activities and dose rates at I m for authorizing patient release for thyroid cancer and hyperthyroid patients (based on SNM/ACNP guidebook).
Thyroid cancer Hyperthyroidism Activity in GBq (mCi) 18.2 (493) 3.0 (80)
Dose rate in mSv h-1 (mrem h-1) 0.84 (84) 0.14 (14)
Release of patients treated with 1311
673 considered to be negligible due to the use of an intake factor of 10- 6* This is certainly a preferred approach to that given in the NUREG as it results in more realistic activity and dose rate release limits.
PATIENT RELEASE BASED ON METHODOLOGY DESCRIBED IN THIS WORK We recommend that the patient-specific dose calcu-lation be performed as follows:
DDE(oo) = [34.6 fQ 0]/(l 00 cm)2 and CEDE = Q0 (MBq) X I o-6 X 1.43 X 10-2 Sv MBq-1*
(2a)
Eqn (I a) includes only 2 components representing the thyroidal and nonthyroidal biokinetic components (the non-void period has been eliminated), the factor 0.6 represents a more accurate correction to the exposure rate constant given in eqn (I) (Siegel et al. 2002a) for the extrathyroidal component (the exposure rate constant is appropriately applicable only to activity confined to the thyroid gland), and F and Tcff are the same as those used in eqn (I) for thyroid cancer and hyperthyroid patients.
Note that eqn (2a) recommends use of an intake factor equal to I o-6*
Upon rearrangement and summation of eqns (la) and (2a), the TEDE per unit administered activity is as follows.
In the case of thyroid cancer patients:
- TEDE/Q0 (mSv MBq-1) = 2.82 X 10-4 mSv MBq-1
+ 1.43 X 10- 5 mSv MBq-1; and
- TEDE/Q0 (mrem mCi-1) = 1.04 mrem mCi-1 + 0.053 mrem mCi-1*
In the case of hyperthyroid patients:
- TEDEJQ0 (mSv MBq-1) = 2.16 X 10- 3 mSv MBq-1 +
1.43 X 10-5 mSv MBq-1; and
- TEDE/Q0 (mrem mCi-1) = 7.99 mrem mCi-1 + 0.053 mrem mci-1*
In both cases the internal dose component does not have to be taken into account, as it will always be less than I 0% of the external dose component. The maximum activities for authorizing patient release are I 7. 7 GBq (481 mCi) and 2.3 GBq (63 mCi) for thyroid cancer and hyperthyroid patients, respectively, based on the DDE. A better approach would be to neglect the "10% of the external dose" NUREG guidance as discussed above and include the internal dose component in the calculation. The maximum activities for authorizing patient release are then 16.9 GBq (457 mCi) and 2.3 GBq (62 mCi) for thyroid cancer and hyperthyroid patients, respectively, based on the TEDE.
These activity limits are still conservative as they are based on the use of the DDE for the TEDE, which does not account for attenuation and scatter within the exposed individual (pursuant to IO CFR 20.1003, the DDE is the dose equivalent at a tissue depth of I cm), and therefore only approximates the likely surface entrance 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 of the DDE in the TEDE determination, and according to an NRC Regulatory Issue Summary (U.S. NRC 2003) no prior NRC approval is required. The EDE has been reported to be a factor of 0.6, on average, less than the DDE for 1311 (Sparks et al. I 998). Using this permissible extra-regulatory definition of the TEDE (i.e., TEDE =
EDE + CEDE), the maximum activities for authorizing patient release are 27.2 GBq (739 mCi) and 3.8 GBq (103 mCi) for thyroid cancer and hyperthyroid patients, respec-tively. The administered dosages for these patients will virtually always be less than these activity limits, indicating that all patients are immediately releasable based on patient-specific calculations according to NRC regulations.
NRC regulations pursuant to IO CFR 35.75(b) also require that released individuals be provided with instruc-tions on actions recommended to maintain doses to others ALARA. Pursuant to 10 CFR Part 20.1003, ALARA means making every reasonable effort to maintain exposures to radiation as far below the dose Limits as is practical. NRC has stated that "dose" in this context means the TEDE.
Internal and external doses are not minimized separately, and ALARA efforts should be directed at minimizing their sum, the TEDE. Since the internal dose is such a small fraction of the external dose, the TEDE can be most effectively minimized by efforts to minimize the external dose component through adequate patient instructions. A three step approach is necessary (Siegel et al. 2002a):
- 1. An evaluation of individual's living and working conditions must be performed to ascertain whether or not the patient can be safely released;
- 2. An appropriate patient-specific dose calculation should be performed to ensure that no individual will likely be exposed to a dose in excess of 5 mSv; and
- 3. Written, not just oral, instructions that are simple and clear must be provided so that the patient can limit the radiation dose to others to as low as reasonably
674 Health Physics achievable. The Authorized User (AU) physician must be satisfied that patient compliance with these instructions is highly likely.
Each of these three steps is equally important. Just because patients are releasable based on the patient-specific dose calculation does not mean that these pa-tients should necessarily be released. For example, it is important to know if infants, young children, or pregnant women reside in the released patient's home (or are likely to come in contact with the patient) in order to conclude that the patient should be released and/or in order to provide meaningful instructions to minimize exposure to these individuals, which in the professional opinion of the AU physician will be comprehended by the patient and likely complied with. Any licensee releasing patients without giving due consideration to the 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 release pursuant to 10 CFR 35.75(c)]. Clearly, regula-tions will not prevent all unintended exposures. The underlying premise of NRC regulations is that AU physicians will understand radiation safety principles and practices and will make appropriate decisions. Licensees have certain responsibilities and need to implement policies and procedures to ensure adequate and effective radiation safety practices.
The NUREG is of limited value in providing appro-priate and adequate patient instructions. As a good example, the suggested durations of the instructions provided for the occupancy factor selection in Section B.1.2 do not differentiate between thyroid cancer and hyperthyroid patients. As demonstrated by our analyses of eqn (1 ), 30% of the total dose is attributable to the time period from 8 h post-administration to total decay in the case of thyroid cancer patients, while 87% of the total dose is delivered over this same time period for hyper-thyroid patients. It seems appropriate, therefore, that the Table 3. Summary of maximum releasable activities.
Method (TEDE definition)
I. NUREG
- 3. This work
' NA = not applicable.
December 2007, Volume 93, Number 6 times necessary for the relevant instructions to remain in effect should differ for these two groups of patients.
Finally, it is important to note that radioactive articles in the household trash of patients are sometimes appearing at solid waste landfills that have installed radiation monitors to prevent the entry of any detectable radioac-tivity. Even though the radioactivity levels potentially contained in any household waste of patients released in accordance with IO CFR 35.75 pose an insignificant hazard to the public health and safety or to the environ-ment, professionals can take steps to avoid issues with landfill owners and operators and even individual states (Siegel and Sparks 2002). It is probably wise to instruct patients to avoid or minimize use of items that cannot be disposed of via*plumbing (toilet, sink, dishwasher, wash-ing machine), such as plastic utensils and paper plates (Siegel 2004).
SUMMARY
OF MAXIMUM RELEASABLE ACTIVITIES Table 3 summarizes the maximum releasable activ-ities for both hyperthyroid and thyroid cancer patients presented in this work.
All values in Table 3 were determined based on an occupancy factor of 0.25 for the extrathyroidal and thyroidal components. If a licensee determines that a lower occupancy factor ( e.g., 0.125) is justified for a particular patient, then even higher activities would be calculated.
THE LICENSEE'S ROLE IN PATIENT RELEASE More realistic calculations allow for even higher releasable activity levels, particularly for thyroid cancer patients. The guidance approach involving patient-specific dose calculations results in a releasable activity limit similar to our calculational approach for hyperthy-roid patients (2.1 GBq vs. 2.3 GBq), but the activity limit Activity in GBq (mCi)
Hyperthyroidism 1.2 (33)
- 2. 1 (57) 2.0 (53) (NA) 3.0 (80) 2.3 (63) 2.3 (62) 3.8 (I 03)
Thyroid cancer 1.2 (33) 8.2 (221 ) (NA)'
6.6 (179) 18.2 (493) 17.7 (481) 16.9 (457) 27.2 (739)
Release of patients treated with 1311
675 for thyroid cancer patients is significantly lower (6.6 GBq vs. 16.9 GBq) using the regulatory definition of the TEDE. The similarity in the hyperthyroid case is due to the fact that the majority of the estimated dose to others is due to the thyroidal component and the overly conser-vative assumptions made in guidance have minimal effect. If a licensee chooses to replace the DDE with the EDE, then the release limits are even higher (27.2 GBq and 3.8 GBq for thyroid cancer and hyperthyroid pa-tients, respectively) and now significantly different even for hyperthyroid patients. Thus, it is reasonable to ask the question, "Why have licensees broadly adopted the NUREG guidance for patient release?"
Given that regulatory requirements for patient re-lease have historically been unrealistically conservative and that the current NUREG guidance procedures are still overly conservative, particularly with regard to thyroid cancer patients, it is difficult to justify providing such information to nuclear medicine physicians to determine patient release limits. Perhaps many licensees have adopted these procedures because most of their clinical treatments involving Na 131I can be managed under the guidance release limits of either: 1) 1,221 MBq based on the default-value approach; or 2) 2.1 GBq and 6.6 GBq using the patient-specific calculational dose approach for hyperthyroid and thyroid cancer patient treatments, respectively. Rarely, they might argue, is there a need for hyperthyroid treatments involving
> 1,221 MBq or thyroid cancer treatments with > 6.6 GBq and, therefore, the higher activity release limits in our recommended approaches may not be required. The important point is that, quite distinct from medical judgments by physicians in deciding what activity pre-scription is best suited for their patients, the activity release limits we have determined here from a radiation safety perspective pose little or no adverse impact on the public health and safety. Many institutions are providing thyroid cancer treatments based on a dosimetric ap-proach, rather than an empiric fixed activity, generally involving an activity prescription > 7.4 GBq, and these institutions need not be subjected to an unnecessary "tie-down" license condition preventing them from re-leasing their patients with activities greater than 6.6 GBq.
If more realistic activity limits, as presented and discussed in this work, were given to physicians by their Radiation Safety Officers (RSOs), higher activity admin-istrations might be more routine. For example, treating autonomous hyperfunctioning nodules with empiric fixed dosages of 1311 that have been determined solely on the basis of the quantity of activity that would not require hospitalization ( currently believed by many to be 1,221 MBq) is a common practice. However, for large nodular thyroid glands, administered dosages, if calculated based on volume and fractional uptake of iodine, could exceed this activity limit (lagaru and McDougall 2007). It is important to note that RSOs are not required to blindly accept and adopt optional NRC guidance, but they are required to release radioactive patients in a manner that complies with 10 CFR 35.75 and, therefore, must be proficient in determining the likely dose to others from exposure to such released patients. We have shown that less conservative activity levels can achieve these goals.
RSOs generally are not able to devote the time or resources necessary to perform complex modeling cal-culations to verify the adequacy of NUREG recommen-dations. Thus, it is common practice for licensees to simply adopt NRC guidance documents without critical assessment of their strengths and weaknesses. Uniform adoption of a single standard across the profession also facilitates the work of NRC inspectors. We have dem-onstrated, however, that a more scientifically sound but still easily implementable approach, i.e., one not requir-ing patient-specific biokinetic studies and dose calcula-tions, can achieve the same goals as use of the NUREG, and lessen the burden on licensees, patients, and others.
CONCLUSION Licensees must comply with NRC regulations but are under no obligation to adopt NRC guidance. Pres-ently, there appears to be a considerable degree of confusion as to what is required by the regulations and what is optional, i.e., guidance. Rigid adherence to the guidance recommendations has placed an undue burden on nuclear medicine therapy patients and their families, as well as licensees responsible for ensuring compliance with NRC requirements. We have shown that guidance-suggested releasable activity limits are similar to those we have calculated for hyperthyroid patients, 2.1 GBq (57 mCi) vs. 2.3 GBq (62 mCi), but are much lower for thyroid cancer patients, 6.6 GBq (179 mCi) vs. 16.9 GBq (457 mCi) using the regulatory definition of the TEDE.
Higher limits are both possible and reasonable, if the permissible extra-regulatory definition of the TEDE is used in which the EDE, rather than the DDE, is deter-mined. We maintain that professionals evaluating com-pliance with 10 CFR 35.75 should use the approaches presented here to comply with NRC requirements. These approaches are easily implementable by licensees, as they do not require patient-specific biokinetic studies and dose calculations.
A repeat of the quiescence with which NRC' s "30-mCi rule" was accepted by those in the radiation safety community is not justified. As chronicled by Siegel (2000), this activity limit, lacking scientific justi-fication or evidence demonstrating it would actually
676 Health Physics present a hazard to the public health and safety, was responsible for inappropriately low treatme_nt activities, unnecessary patient hospitalizations and increased health care costs for over 50 y.
Use of the 1,221 MBq activity (or 0.07 mSv h-1 at I m dose rate) patient release limit based on the NRC guidance "default" approach should never be employed by any licensee permitted to release patients pursuant to JO CFR 35.75. These values indicate lower limits for which NRC does not believe it necessary to perform patient specific calculations to demonstrate that others potentially exposed to a released patient will not likely receive a radiation dose that exceeds 5 mSv. However, the assumptions made by the NRC in arriving at these guidance values are inaccurate and unjustifiably conser-vative. Even if a licensee were to follow the patient-specific dose calculational approach provided for in NRC's NUREG guidance document, thyroid cancer and hyperthyroid patients receiving greater than 6.6 GBq and 2.1 GBq, respectively, would always have to be hospi-talized. There is also no scientific basis or justification for these so-called "forced activity level" confinements.
The NUREG patient release methodology also intro-duces a regulatory burden not as yet codified in NRC requirements. Indeed, patients, particularly thyroid can-cer patients, can be released in accordance with NRC regulations with much higher activities, as demonstrated in this work, without adversely impacting on the public health and safety.
Patients and their families share the largest burden when overly restrictive release criteria are enforced.
Alternative guidance for patient release by stakeholder professional organizations is available for use (Siegel 2004). Licensees may adopt and implement the approach presented here, or they could develop their own appro-priate approach given that a wealth of scientific literature now exists (Siegel et al. 2002b; Mathieu et al. 1999; Barrington et al. 1999; Zanzonico et al. 2000; Venencia et al. 2002; Siegel et al. 2002a). Possible consequences of overly rigid adherence to the NUREG procedures include the under-treatment of patients, issuance of overly restric-tive release instructions, and unnecessary confinement of patients to hospital beds. The significant and unjustified additional cost to patients and their loved ones, the require-ment for hospitals to prepare and decontaminate unneeded rooms so that staff can receive unnecessary radiation expo-sures, and the adoption of substandard patient release policies associated with licensee adherence to NRC patient-release guidance should be critically re-evaluated given the guidance presented in this work. These procedures are in compliance with NRC requirements and their use can lessen the burden on licensees.
December 2007, Volume 93, Number 6 REFERENCES Barrington SF, O'Doherty MJ, Kettle AG, Thomson WH, Mountford PJ, Burrell DN, Farrell RJ, Batchelor S, Seed P, Harding LK. Radiation exposure of the families of outpa-tients treated with radioiodine (iodine-131) for hyperthy-roidism. Eur J Nucl Med 26:686-692; 1999.
Berman M, Braverman LE, Burke J, Groot LD, McCormack KR, Oddie TH, Rohrer RH, Weliman HN, Smith EM. MlRD Dose Estimate Report No. 5: Summary of current radiation dose estimates to humans from 1231, 1241, 1251, 1261, 13°.I, 1311, and 1321 as sodium iodide. J Nucl Med 16:857-860; 1975.
Brodsky A. Resuspension factors and probabilities of intake of material in process (Or "Is I0- 6 a magic number in health physics?"). Health Phys 39:992-IOOO; 1980.
Buchan RCT, Brindle JM. Radioiodine therapy to outpa-tients-the contamination hazard. Br J Radiol 43:479 - 482; 1970.
Carey JE, Kumpuris TM, Wrobel MC. Release of patients containing therapeutic dosages of iodine-13 I from hospi-tals. J Nucl Med Technol 23:144-149; 1995.
Grigsby PW, Siegel BA, Baker S, Eichling JO. Radiation exposure from outpatient radioactive iodine [1311] therapy for thyroid carcinoma. JAMA 283:2272-2274; 2000.
Hanscheid H, Lassmann M, Luster M, Thomas SR, Pacini F, Ceccarelli C, Ladenson PW, Wahl RL, Schlumberger M, Ricard M, Driedger A, Kloos RT, Sherman SI, Haugen BR, Carriere V, Corone C, Reiners C. Iodine biokinetics and dosimetry in radioiodine therapy of thyroid cancer: proce-dures and results of a prospective international controlled study of ablation after rhTSH or hormone withdrawal.
J Nucl Med 47:648 - 654; 2006.
Iagaru A, McDougall IR. Treatment of thyrotoxicosis. J Nucl Med 48:379-389; 2007.
Jacobson AP, Plato PA, Toeroek D. Contamination of the home environment by patients treated with iodine-131:
initial results. Am J Public Health 68:230- 235; 1978.
Loevinger R, Budinger TF, Watson EE. MIRD primer for absorbed dose calculations. New York: The Society of Nuclear Medicine; 1988.
Mathieu I, Caussin J, Smeesters P, Wambersie A, Beckers C.
Recommended restrictions after 1311 therapy: measured doses in family members. Health Phys 76:129-136; 1999.
Schneider S, McGuire SA. Regulatory analysis on criteria for the release of patients administered radioactive material.
Washington, DC: U.S. Nuclear Regulatory Commission; NUREG-1492 (Final Report); 1996.
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. Washington, DC: NCRP; Proceedings No. 21; 1999: 187-199.
Siegel JA. Tracking the origin of the NRC 30-mCi rule. J Nucl Med 41: I0N-l 6N; 2000.
Siegel JA. Nuclear Regulatory Commission regulation of nuclear medicine: Guide for diagnostic nuclear medicine and radiopharmaceutical therapy. Reston, VA: Society of Nuclear Medicine; 2004.
Siegel JA, Sparks RB. Radioactivity appearing at landfills in household trash of nuclear medicine patients: much ado about nothing? Health Phys. 82:367-372; 2002.
Siegel JA, Kroll S, Regan D, Kaminski MS, Wahl RL. A practical methodology for patient release after Tositu-momab and 1311-Tositumomab therapy. J Nucl Med 43:354-363; 2002a.
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677 Siegel JA, Marcus CS, 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; 2002b.
Sparks RB, Siegel JA, Wahl RL. The need for better methods to determine release criteria for patients administered radio-active material. Health Phys 75:385-388; 1998.
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U.S. Nuclear Regulatory Commission. Use of the EDE in place of the DDE in dose assessments. Washington, DC: U.S.
Nuclear Regulatory Commission; NRC Regulatory Issue Summary 2003-04; 2003.
U.S. Nuclear Regulatory Commission. Model procedure for release of patients or human research subjects administered radioactive materials. Washington, DC: U.S. Nuclear Reg-ulatory Commission; NUREG-1556, Vol. 9, Rev. I, Appen-dix U; 2005.
Yenencia CD, Germanier AG, Bustos SR, Giovannini AA, Wyse EP. Hospital discharge of patients with thyroid carcinoma treated with 1311. J Nucl Med 43:61-65; 2002.
Zanzonico PB, Siegel JA, 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.
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:
WhereD(t) 34.6 r
Qo Tp r
t
= Accumulated exposure at time t, in roentgens,
= Conversion factor of 24 hrs/day times the total integration of decay (1.44),
= Specific gamma ray constant for a point source, R/mCi-hr at 1 cm,
= Initial activity of the point source in millicuries, at the time of the release,
= Physical half-life indays
= Distance from the point source to the point of interest in centimeters,
= Exposure time in days.
The fallacies in this equation are:
(Equation 1)
- 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 1311.
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:
D ( Cf) )
34. 6 x o. 2s x A x r 1, 2 x r ( 1
( } 00 C111 ) 2 e
- 0. 693 X 00 J T1 12
[) ( X) )
s. 66 x 1 o -4 A x r1 1 2 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 of Nuclear 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 Radio pharmaceutical 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 1311. 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 F J. 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 1311-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 of Nuclear 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 1311. 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 1311 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 27th 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