ML20216D034
| ML20216D034 | |
| Person / Time | |
|---|---|
| Issue date: | 11/18/1994 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20013H248 | List: |
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-085, AE41-2-85, NUDOCS 9804150155 | |
| Download: ML20216D034 (91) | |
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s 7
@fficial Transcript of Prococdings I i
NUCLEAR REGULATORY COMMISSION PDR p){f L} l - >
Title:
Advisory Committee for the Medical Uses of Isotopes Docket Number: (not applicable)
Location: Rockville, Maryland Date: Friday, November 18,1994 Work Order No.: NRC-36 Pages 314-490 b ! O ' ". I O 0lDjj Ypl NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433 g41g155980402
i 314 V 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 +++++
4 MEETING S ADVISORY COMMITTEE FOR THE MEDICAL USES OF ISOTOPES 6 (ACMUI) 7 +++++
8 FRIDAY, 9 NOVEMBER 18, 1994 10 +++++
11 ROCKVILLE, MARYLAND 12 +++++
13 The Advisory Committee met at the Nuclear 14 Regulatory Commission, Two White Flint North, Room T2B3, 15 11545 Rockville Pike at 8:00 a.m., Dr. Barry A. Siegel, 16 Chairman, presiding. ,
17 18 COMMITTEE MEMBERS:
19 DR. BARRY A. SIEGEL Chairman 20 JUDITH I. BROWN Member 21 DR. DANIEL F. FLYNN Member 22 DR. WIL B. NELP Member 23 24 25 l NEAL R. GROSS j COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON, D C. 20005 (202) 2344433 i
t 315 V 1 ACMUI STAFF PRESEMT:
_ 2 Robert M. Quillin 3 Dr. Judith Anne Stitt 4 Dennis P. Swanson 5 Dr. Louis Wagner 6 Dr. David Woodbury 7
8 ALSO PRESENT:
9 Bob Ayers 10 E. William Brach 11 Larry Camper 12 Kitty Dragonette 13 Dr. John E. Glenn 14 Cathy Haney 15 Dr. Patricia Holahan 16 Florence Kaltovich 17 Stephen A. McGuire 18 Sally Merchant 19 Dr. Bill Morris 20 Dr. Carl Paperiello 21 Dr. Myron Pollycove 22 Robert J. Prato 23 Dr. Pat Rathbun 24 Janet Schlueter 25 Stewart Schneider NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON. D C 20005 (202) 2344433 1
b 316 y 1 ALSO PRESENT (Continued) :
2 Katherine Seifert 3 Torre Taylor 4 John Telford 5
6 7
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9 10 11 12 1
13 14 i l;
15 16 17 18 19 20 ,
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y 1 I li D E X 2 AGENDA ITEM PAGE 3 Release of Patients Containing Radiopharmaceuticals 325 4 or Permanent Amplants, 35.75 5 Advance Notice of Proposed Rulemaking for Part 35 404 6 Misadministrations, Patient Follow-up, Notification of 414 7 Responsible Relatives, and Use of NRC Consultants 8 Administrative Matters 478 9 Closing 488 10 J I
11 j 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE (SLAND AVENUE. N W.
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t 318 g 1 PROCEEDINGS 2 (8:01 a.m.)
3 CHAIRMAN SIEGEL: Why don't we get this show on 4 the' road? Judy Brown and John Graham are still not here 5 yet, but from the interest of, as John says, beating the 6 hurricane so we all get out of here today and having once 7 gotten trapped by a northeaster for too long extra days on 8 the East Coast, I'd just as soon get out of here today. I 9 think we should begin the day's business.
10 We're going to take a brief, very brief, 11 probably 10 minutes at most, diversion from the agenda to 12 revisit the issue on brachytherapy that we talked about 13 last night to talk a little bit about the definition of the 14 treatment site.
15 We had some materials that we passed out last 16 night from ICRU, document that Larry gave us. But, in 17 addition, Trish has a suggestion, -- right? -- which she's 18 going to share with us.
19 DR. HOLAHAN: I took this out of the document 20 that you were all handed yesterday on the definition of 21 irradiated volume. And we sort of hashed over yesterday 22 what's wrong treatment site and what is right treatment 23 site.
24 I guess the question that we're posing to the 25 ACMUI is the irradiated volume here -- and they define it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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b 319 g 1 as "the volume that exceeds an absorbed dose, which is 2 significant in relation to tissue tolerance," and they have 3 used as an example 50 percent isoduse line, but I don't 4 think that's hard and fast. They said as an example in the ,
5 document you've received of the specified target absorbed 6 dose.
7 Could the wrong treatment site be considered 8 what was outside the irradiated volume so that you could 9 still have a misadministration? If it was within the 10 irradiated volume, it would only be a misadministration if 11 it exceeded the threshold specified in the 12 misadministration requirements for that point?
13 So if it's at the 50 percent ieodose, it would 14 have to exceed 20 percent greater than the 50 percent 15 isodose line. And if that is a reasonable approach for the 16 irradiated volume, would you have any recommendations as to 17 what this percentage line should be?
18 CHAIRMAN SIEGEL: I'll defer to --
19 MEMBER FLYNN: One problem is that --
)
20 CHAIRMAN SIEGEL: -- Dan and Judy. l 21 MEMBER FL' INN: -- when I was in a working group I
1 22 when we were working on the quality management program as l
l 23 advisers to the NRC, th're were several radiation )
24 oncologists and about four radiotherapy physicists. This 25 is just for radiation oncology.
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i 320 g 1 The problem that came up is that we felt that 2 as some centers may define their dose to a point, some l 3 centers may define their dose to a treatment volume and l
4 some centers may still use milligram hours, that we didn't 5 want to force them into a situation to do something that
{ 6 they're not currently doing in clinical practice.
, 7 DR. HOLAHAN: So if they prescribed in 1
8 milligram hours, they would not have a treatment plan l 9 identifying the isodose?
10 MEMBER FLYNN: And after several days of 11 arguing and debate, we couldn't come to a single 12 definition. And so what happened in those days was that we I
13 suggested to the NRC and the NRC accepted that the dose as 14 far as brachytherapy is concerned could be defined as t
15 source, strength, and time, which is milligram hours, or 16 dose, absorbed dose, to a target absorbed dose without 1
17 specifying where the dose was defined to.
- 18 Wherever the licensee does define the dose to 19 as part of their practice in treating the patients, because 20 of the wide discrepancy of how radiotherapy licensees l
21 prescribe their doses in brachytherapy, low-dose i 22 brachytherapy, it was decided to keep it as less of a 23 prescriptive type of a definition because then you would 24 end up forcing licensees to change their practice and the 25 way they are defining their dose because they're following NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON, D.C. 20005 (202) 234 4433
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, 1 patients along, whether we agree with how they do it or 2 not, to see what kinds of complications they might get as 3 part of routine radiotherapy and what kind of local control 4 of disease they get. And they're monitoring that based on 5 the way they always have been prescribing "the dose."
6 But maybe since Dr. Stitt is on the ASTRO 7 Physics committee, maybe this is something that they will 8 have to re-debate and reargue. I don't think you can come 9 up with a simple solution.
10 DR. STITT: I'm guessing. Is this right, 11 Trish, that the irradiated volume would be something that 12 NRC would be particularly interee;ed in for the 13 interstitial sorts of things where you've got radium seeds 14 because that's about the only occasion when radiation 15 oncologists use that terminolczy?
16 DR. HOLAHAN: You mean irradiated volume?
17 DR. STITT: Yes. Dan's right. If you're 18 talking about -- essentially all of the gyn implants are 19 either milligram hours -- I'm on the newest Cervix Patterns 20 of Care that's just getting geared up. And we're geared up 21 to the point where we're just now looking at how we're 22 going to collect data and in what forms.
23 You can't use milligram hours for high-dose 24 rate because it simply is not done that way. But it is 25 most commonly done as a dose to a point. Again, you can NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON. D C. 20005 (202) 234 4433
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, 1 use all of that for misadministration percentages. This 2 could be useable for the circumstances when you're talking i l
3 about volume implants because, obviously, it is talking l'
4 about a volume. So for volume implants, which is basically 5 all of the interstitial work, in some places you're using 6 several points as a descriptor or an isodose line that i
7 encompasses a certain volume. l l
8 I think this is something that maybe at this l 9 point ought to be put out on the table. Let folks think 10 about it. Take it to the brachytherapy group specifically 11 because they do a lot of interstitial work, the members of ,
l 12 the ABS. And see if this maybe needs to be made a part of 13 how we're defining things.
14 DR. HOLAHAN: All right. So you're saying for 15 the intracavitary, it would not necessarily apply because i
16 it would not have the --
17 DR. STITT: That is right. That would not work 18 for intracavitary because almost all of that is to a point. l 19 Now, the volume is really what you're interested in, but we 1
20 sort of interpolate by prescribing to a variety of points.
21 CHAIRMAN SIEGEL: Don't you have isodose data, i
22 though, --
23 DR. STITT: Yes.
24 CHAIRMAN SIEGEL: -- from your treatment plan, 25 --
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323 1 DR. STITT': Yes.
2 CHAIRMAN SIEGEL: -- even if you prescribe it 3 that way?
4 DR. HOLAHAN: So you have the isodose.
l 5 DR. STITT: But what we certainly don't want to I 6 do is start getting people in a double bind. I mean, if 7 you want to give 3,000 centigray at Point A and your volume 8 distribution will have -- actually, it will be based on I l
9 where you prescribe some points.
10 And then your volume, your isodoses sort of lay 11 around that, but there could be some circumstances wherein 12 you're going to actually get yourself backed into a corner I i
13 by trying to use both. So it is possible. !
14 CHA.TRMAN SIEGEL: That's why in a way I'm j 15 actually kind of attracted to this very preliminary l 16 proposal that the physicists have already come up with, i 17 which is kind of ignoring, not defining a treatment site, 18 but worrying more about when one should be reporting and 19 fretting about when something else got treated that you 20 didn't expect to get treated.
21 And by tieing it to some percentage above or 22 below the expected dose if the t reatment had gone as 1
23 planned and also adding a threshold so that you don't 24 report trivial doses, you kind of get around the problem.
25 Then you're not forced to defining what is the treatment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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324 1 site, which is kind of a difficult problem, as we've 2 already figured out.
3 And you still capture the data that is of 4 importance to you in terms of finding out whether a 5 systematic problem is going on, and you still protect 6 people who might be having misapplications of the 7 technology.
8 MEMBER FLYNN: Several years ago ICRU came out 9 with a report, Number 38, written by clinicians and 1
10 physicists, primarily physicists., in an effort to define 11 for low-dose rate implants, instead of getting away from 12 paracentral dose that the Patterns of Care study uses or 13 Point A, a treatment volume.
14 Unfortunately, most people have chosen not to 15 adopt ICRU Report Number 38. And so it becomes a problem 16 if you become too prescriptive. I don't know a way around 17 it myself.
18 DR. STITT: Yes. ICRU 38 is really used in 19 Europe and essentially not at all in this country, just 20 never caught on.
21 CHAIRMAN SIEGEL: It seems to me that this is a 22 sufficiently complex topic that this is the kind of things 23 that a variety of workshops are going to be very useful to 24 help you focus what the community is doing and what the 25 community can live with that makes sense from the point of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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, 1 view of the way they actually practice.
2 I mean, we've seen in the past that workshops 3 are pretty effective at getting some of these rules in 4 their formulative stages. And I think I would encourage 5 you to do that and also to pick the therapy physicists for 6 this committee quickly so that that person can participate 7 in that activity from the beginning.
8 DR. HOLAHAN: This is, yes, one of the things 9 we're going out with the workshops to try and start 10 flushing out.
11 CHAIRMAN SIEGEL: Right.
l 12 DR. HOLAHAN: Okay.
13 CHAIRMAN SIEGEL: Good. Thanks. j 14 DR. HOLAHAN: Thank you.
15 TRElataiEQF+ PATIENTS *GMTk!NfWCRAD20MN 16 W ?r .I G Y W C 3 M ~w i
17 CHAIRMAN SIEGEL: All right. Let us move on, 18 then, to the real agenda, to " Release of Patients i
l 19 Containing Radiopharmaceuticals or Permanent Implants, l 20 35.75."
21 Kitty Dragonette is going to tell us where this
- l. 22 activity stands. And, Kitty, before you do, let me give a l
23 little bit of background information. As you all know, 24 this is something we've discussed at at least one and, 25 actually, probably a couple previous meetings. I NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W l I
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, 1 There's obviously a proposed rule on the 2 street. And at the October 20th Commission briefing, on 3 that day following that meeting, three members of this 4 Committee, myself Bob Quillin and Lou Wagner, sat down with 5 some folks from the medical program and some folks from 6 research just to talk about the response letters, to talk 7 about what problems the NRC saw given the response letters-8 that had come from members of the public, and to put forth 9 some potential ideas for solution.
10 We did not attempt to reach any sort of 11 consensus for the Committee because we were not an 12 officially convened portion of the ACMUI or even a 13 subcommittee. It was just a working dir.cussion. But we 14 did come up with some ideas.
15 I'd like to just tell the Committee very 16 briefly the kinds of ideas that we'came forth with. And 17 then we can see how Kitty and the other folks in research 18 have reacted to those ideas.
19 \Onelisithetithefargdmentifo dim 5EiAgifrom(the 20 100-millirem,Part 20slimit:to ther500-millirem;~exemp~ tion,
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21 :if A~you1will;;. wasToneithat!?ne~eded: to be:made ;primari}y2'eaut 22 y . cost / benefit; basis p
~
23 Two wasithatZtheYactiivitles2that!Twere!goingito
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24 , begtied;tonthis wholuilssueishould be;activitiesithatKare I 25 y currentlygtiedLto;a_writtenTdirectiv'e"and'.that?this; concept NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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e :shouldErgnajp;1 3 rgelyysponGwithErespect to thosa 2 !activitiesE tha'tp. don ' ticurren'tly : require 2a; writ; ten u directiye so' that ;you: wouldn't warit to' 'ges :into this ' patientL releasec 3
4 criteria 1 discussion"witht. respect.1to diagnosticyimaging 5 Pdoses;used:ininuclear; medic.ine.
6 And the particular problem for that relates to 1 7 the fact that breast-feeding had the potential to be 8 brought in under the umbrella of this overall patient 9 release criteria, ' viewing l tlie - infant, thenf as almember,sof_;
_ m.
I 10 -
Ithe ? general 2public'.
11 V:And.it2then became:potentiallyivery complicated 12 and p'otentially/could involve a substantialL:amountsof.
13 9 resources toccausel li'censees to;really,have-to.do-:a'lotro_f 14 <recordkeeping,Einvestigation,7 documentation:that all7 women 15' of"the'right aye group who are comingjingfor. nuclear 16 ' medicine ~examinationsLcould prove that they were3'.t 17" MElstifeedingiand liave tbahavetsome secord for that.
'.t 8 Soyljatjyelwere _sortJof thinking.cisfthat?itO
~
19 ight be better to tie the. breast-feeding'partiof this'.to. ;
1 20 an_ entirely separate rule related to breast-feedingEin
^
21 pregnancy,Ewhich we r know--is-something.that has been talked 22 y about;for some timeThere.
23 I think those were the principal issues that we 24 talked about.
25 MEMBER BROWN: So to remain silent on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON, O C 20005 (202) 2344433
328 e 1 breast-feeding is to avoid the necessity for recordkeeping 2 for the doctors?
3- CHAIRMAN SIEGEL: Let's go through it, Judy..
4 ;ItdsMotito; avoid;the;necygygggggheepsmaJtenganach 5 l .asd t2 1s;toyavoid theipotentiaEtoicompletelyZdiWrupt31he 6 i pirset t bu',%hsrdayis tordayJ pract ice EoEnuclinar7 medicine 7 'l becauseTofEt !hsIneed':that!pou"N-8 MEMBER BROWN: Completely disrupt the day to 9 day practice of nuclear medicine?
10 CHAIRMAN SIEGEL: Yes, yes.
11 MEMBER BROWN: You don't think that's a bit of 12 an overstatement?
13 CHAIRMAN SIEGEL: I actually don't. Let's work 14 through this, and we'll see. So, Kitty, go ahead. Maybe a 15 little bit.
16 (Slide) 17 MS. DRAGONETTE: Well, you already know what 18 this agenda topic is.
19 (Slide) 20 MS. DRAGONETTE: I'm here on behalf of Don 21 Cool, who is still out recovering from a pretty nasty 22 infection, sinus infection. Stewart Schneider, who is the 23 technical lead, is in the room and is going to help bail me 24 out when I need it. And so is Stephen McGuire, who talked 25 to you yesterday about wrong patient. f NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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1 329 e 1 (Slide) \
2 MS. DRAGONETTE: Well, as Dr. Siegel mentioned, 3 there's a proposed rule out on the street. It was {
4 published in June. Comment period expired August 29th, 5 althouch sotae comments on some of the related documents are 6 still coming in. The draft regulatory guide was published 7 essentially in parallel, as was the regulatory analysis.
8 In response to that notice, we've gotten 56 9 comment letters, over 80 percent from the medical 10 community, 4 from states and 4 from others; on the draft i 11 regulatory guide, 6 comment letters, although things get l i
12 combined and whatever; and then one comment letter )
13 addressing specifically the regulatory analysis.
4 14 (Slide) 15 MS. DRAGONETTE: As Dr. Siegel mentioned, you 16 considered this matter before, but there are some new i 17 members on the Committee. So just to recalibrate us and 18 make sure we all remember what the proposed rule provisions 19 were, I was just going to review them very quickly.
20 The proposed rule would modify Part 20 to ,
21 explicitly exclude the dose contributions from patients 22 released in accordance with the proposed provisions of Part 23 35, the annual dose limit of 500 millirem. It was 24 proposing to change the Part 35 criteria from the dose rate 25 and 30-millicurie activity numbers to the 500-millirem a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. O C. 20005 (202) 234 4433
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, 1 year annual dose limit.
2 (Slide) 3 MS. DRAGONETTE: It also had some accompanying 4 implementation features that when the dose to the person 5 most likely to receive the highest. exposure exceeded 100 6 millirem, the licensee was to provide written instructions 7 and to keep a record.
8 (Slide) 9 MS. DRAGONETTE: The major issues raised by the 10 commenters and that have come out of discussions among the 11 NRC staff and with some of you individually are basically 12 in three areas: the recordkeeping burden and requirement 13 at the 100-millirem threshold providing written 14 instructions being prescriptive that they must be written, 15 as opposed to just provide instructions; and then the 16 breast-feeding child issue.
l 17 (Slide) 18 MS. DRAGONETTE: The strongest opposition to 19 the provisions of the rule had to do with the recordkeeping 20 burden at the 100-millirem threshold.
21 (Slide) 22 MS. DRAGONETTE: I just want to make sure I I 23 highlighted the things I had planned to highlight ahead of 24 time.
25 The commenters argued that it would involve a !
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, 1 lot of time, effort, and dollars to keep those records for 2 every patient where your estimated dose is greater than 3 100. And, consequently, the commenters felt that we 4 underestimated the burden.
5 Now, what are some of the options that we're 6 considering to try to address this problem? Two basic 7 options. The first one, probably the leading one, but 8 still both under discussion, mis;torjust;el.iminaEETEWe 9 ;requirementCfdfieEIddk5 epi'ngjh$n581 eave;it Ap;toleach t 10 + . individual: licensee 1what; sort,of.~-n. documentation they;migh,t
.. .. _ a 11 'WantTtoWeptMoIshS#a'nfi nspectorithat they were abiding by 12 the rule, but provide guidance in the regulatory guide that 13 would say "Here's at least one acceptable way" or "Here are 14 some ideas that you might want to use" and in the guidance 15 cover the potential for multiple exposures within the year.
16 Part of what was driving the recordkeeping 17 threshold at 100 was so that there was a record to you 18 could go back and look if the patient had gotten an iodine 19 administration 3 months earlier, you could take both of 20 those into account to determine that you had met the annual 21 dose limit. We were worried about the per administration.
22 s JSo if: yon eliminate 7all thefrecordkeepingEthen 23 you would;in'the; regulatory guidance say7 it's a (
24 s performance-based; rule. So you have flexibility on how you _
\
25 meet it, but;youf should;still- address ;the - f act : that . it t s ar} V[3 I
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- l 332 j 1 Qualydose limit,-providerthe*guid.a.ncw
.ww ~-u _,t-,- - -
am 2 There is concern among the staff about if you 3- do case by case calculations. In the regulatory guide that 4 was published for comment, it had three basic components.
5- It had a table of by radiopharmaceutical, of the. activities 6 and dose rates at the 100 and the 500 levels. It was a 7 cookbook way of complying with the rule that if your 8 patient had this much activity or this was the dose rate, 9 you met the 100 or you met the 500.
10 So it gave you that cookbook way of' complying.
11 It also gave guidance on the instructions to give to the 12 patients. And it had a third provision, which was to do 13 case by case calculations if you felt that you had an 14 unusual circumstance where you could justify release at 15 levels higher than those table values.
16 And there is still concern among the staff 17 about the more or less unbounded provision of that and some 18 concern that perhaps records on what assumptions you used
.19 to justify those releases at levels higher than in a table 20 should be kept. So that's still under discussion.
21 **D6eW4he1Commit!6&WsWt!houshEinf6d3}iEt, 22 whetherm
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just, as the..
-. .- case by+. case.m. calculations?f 3fiyouthaditoa 23 keep a record.on that.but not7anytofAthe: othersirwouldethat 1
eu c.m wh ,m .m - ~ -
24 be 2.a._significantsburden,7 25 DR. GLENN: I'd like to just make one comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON, O C. 20005 (202) 2344433
333 4 'l. so that the Committee is aware. Barry referred to the fact 2 that if you think of this in terms of the context of the 3 written directive, that there is, in fact, already a 4 recordkeeping requirement for the written directive for the 5 procedures most likely to result in the larger exposures.
6 So it's not that there would be no recordkeeping at all 7 under that first open.
8 MS. DRAGONETTE: If you put a requirement in, 9 then you would have to put something, --
10 DR. GLENN: Right.
11 MS. DRAGONETTE: -- some kind of annotation, in 12 that written directive. But yes, it wouldn't be a new 13 record'other than it's a new entry on it or something.
14 DR. GLE,NN.; But..for the most+significant 15 administr.ations. ugh.-.e..r.o would h a.recordmofJ he 16 ' 'admiiil"sEation',~ not-of-the dose-evaluation:-So-it-could-be 17 ' dame N 7 18 DR. WAGNER: What you're talking about, are you 19 talking about only for procedures that require written 20 directive or are you still talking about all procedures?
21 MS. DRAGONETTE: That would be any procedure 22 where you exceeded the cookbook table values where we have 1
23 calculated the activity or dose rate. So if the table 24 entry for iodine for the 500 was 33 millicuries, I think, 25 if you wanted to release for the 100 millicuries, then you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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. I would need to do a case by case analysis or have something 2 that has different assumptions than we had in the simple !
l l
3 version that we used to put the table together to justify 4 that hundred and show that it's still likely that the doses i l
5 from the patient would still not exceed 500 millirem.
6 DR. WAGNER: I guess one of my major concerns 7 is that issue about guidance to cover issues such as I
8 potential for multiple administrations. Would we still be ;
1 9 able to use a table for any patient who had multiple 10 diagnostic administrations during a year or would we have 11 to consider the fact that a diagnostic patient might have 12 multiple administrations which would occur at different 13 hospitals?
14 MS. DRAGONETTE: In the diagnostic arena, 15 you're probably not going to get into trouble with many of 16 the procedures other than -- and we'll get to the 17 breast-feeding infant in a little bit and some of the whole 18 body iodine scans. Multiple diagnostics, the diagnostics 1
19 were pretty much below the 100 millirem. And it's unlikely ;
20 that you exceed the five.
21 The major concern in the multiple would be the 22 therapies. And there again you would have a written 23 directive. And hopefully if you are prescribing therapy ;
24 again or these major scans, you would want to know that 25 information about your patient. ,
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. 1 And if you had the flexibility to how you found 2 out whether you asked the patient or the referring 3 physician, ii you had complete flexibility on how you 4 considered that, used whatever was annotated on the written 5 directive, that --
6 CHAIRMAN SIEGEL: I guess in a way the real 7 question, though -- maybe I'm not focused yet this morning.
8 n
- .Tha;;reshquentienyislwhether;yoMneed uwan~ - ~ - -
anythingLatin1M%m 9 theTgapIbetweari'~ 100Imillirems Fand E548~2iid1M 10 That really becomes the fundamental question or 11 whether one is willing to accept that for the unique 12 circumstances of medical administrations, that exposures ;
13 which for the most part or for nearly the entire part will 14 be to the selected population that comprises members of the 15 family which some professional groups have considered to be 16 a special irradiated population that's distinct from the 17 general public and distinct from occupational workers, that 18 there needs to be any recordkeeping whatsoever related to 19 that 400-millirem gap or whether it suffices to say "Let's 20 divide tables that say 'If you're in this range, you're out 21 the door. If you're going to go above this range, then you 22 need to develop special information to show what 23 assumptions you're using to prove _that exposures will be l 24 below that 500-millirem unit, what special instructions 25 you've taken to keep exposures below that limit.'"
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. 1 That I think really is the key question.U2 Edi i l
2 eli'minatingtthat~recordkeepingibetween 100 and 500M il1Frem 3 tets ridTofJthe Mast : maj ority of : the; problem.
I 4 MEMBER BROWN: I need a little background. Who i
5 in their wisdom decided that 100 millirem was the threshold I 6 anyway? I mean, is it just an historical thing that you I 7 all live with? l t
i 8 CHAIRMAN SIEGEL: That's the limit in Part 20 l 1
9 __
I i
10 MEMBER BROWN: Right.
11 CHAIRMAN SIEGEL: -- for exposure to the 12 general public.
{
13 MEMBER BROWN: And has that all been considered 14 ridiculous by the profession that that's just too low? And i 15 why?
16 CHAIRMAN SIEGEL: Well, is it too low? Yes, j l
i 17 it's too low. It's -- '
18 MEMBER BROWN: Because I don't have any 19 judgments to make any differential between 100 and 500. l l
20 CHAIRMAN SIEGEL: If one does what is generally 21 done in the radiation protection community, right or wrong, 1
22 and that is to use a predominantly linear hypothesis for 23 determination of the risks of radiation. l 24
- Andathen..whensyou zthink,in terma;ofra::
25 populationwnotoin c ternis of LindiYidualT human'. beingsabut-in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON. D C. 20005 (202) 234 4433 i
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337 1 teasep refraspapislat4an kend Ns5tE[d5IuEaENMThe 2
- cal ~culations;ryou?say %etrus3 conservatively [dpawythe?W iel 3 dimitrat*100r millireme r of 2 exposure;f rom; these , activities 4 Decause"that1wayrwe can:avoidrany?isubstandal T si$rE5oide 5 population.15 6 MEMBER BROWN: Erring on the side of caution, 7 but now in the --
8 CHAIRMAN SIEGEL: Unequivocally. When you look
.9 at individual' patients, the 100-millirem limit starts to 10 become silly. It suggests, for example, that we should 11 evacuate Denver. It suggests, for example, -- and Carol 12 has got this wonderful idea -- that TWA --
13 MEMBER BROWN: Nobody can fly across country 14 that -- {
15 CHAIRMAN SIEGEL: -- should be forced to keep a l
16 record of my mileage and each year when I reach 100,000 17 miles, they should send me a note, say You've exceed your 18 100-millirem limit for the year because of the extra 19 radiation exposure from flying." I shouldn't get an award.
20 I should get a warning.
21 So when you start thinking in terms of 22 individual people, 100 millirems become unmeasurable in 23 terms of proving that there's a risk to that individual 24 purpose.
25 So the 100-millirem limit is a conservative NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON. D C. 20005 (202) 2344433 l
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338 1 population-based limit that says "We would not like to 2 tomorrow add 100 millirems per year of annual exposure to 3 every human being in the United States because if we did 4 that, then we might begin to start seeing a measurable 5 increase in effects as a result of that."
6 Lou, you're the radiobiologist.
7 DR. WAGNER: Well, I was just going to state 3 that to put it in perspective, everybody in this room, 9 everybody on this continent is going to get about 300 10 millirem every year just from natural background radiation.
11 So the 100 millirem is a small fraction of that.
12 If you take it in Denver, they're going to'get 13 what we get here. It really is quite trivial. VAI M 14 'tLaportantspbintSis!iti:isj;gpopulationgsadgrecommendation,.
15 . SoLuben yyoui go2 t o r the L500 ;milliramint hat !Jr t f or dndividualg 16 And wh;e that does is basically give you one to two years' 17 background radiation equivalent.
18 MEMBER BROWN: Right.
19 DR. WAGNER: So you're living in those kinds of 20 numbers.
21 MEMBER BROWN: Per treatment? That's not 22 multiple treatments?
23 DR. WAGNER: Well, that would be for whatever 24 it is. .That's where you've got to draw the line, --
- 25. MEMBER BROWN: Right.
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339 1 DR. WAGNER: -- if it's multiple treatments or 2 not. And you'd be looking --
3 CHAIRMAN SIEGEL: But annually.
4 DR. WAGNER: -- at the indiJidual members, who 5 would basically be the family. That's what you would be 6 looking at.
7 MEMBER BROWN: I have a question also. Are you 8 going to go back to looking at the comments at all or can I 9 bring that up now? You said there were 56 comments and 80 10 percent were from the medical community, 4 from the states, 11 and 4 from others. What bothers me is that there's no 12 consumer-based group, health research group, women's health 13 network.
14 Thel ='s nobody with enough familiarity with the 15 subject that's so arcane to develop any thoughtful 16 comments. So hearing only from the medical community, who 17 has the patients' interest at heart, of course, but the 18 cost / benefit very much on their mind, doesn't help me. And 19 I'm wondering who the four others were that commented.
20 MS. DRAGONETTE: Stewart?
21 CHAIRMAN SIEGEL: One of the others was an NRC 22 lawyer who commented as a member of the general public.
23 There were --
24 MEMBER BROWN: What was his name? Is that the 25 --
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, 1 CHAIRMAN SIEGEL: I didn't actually bring my 2 stack of letters with me, but Peter Crane, I believe, yes.
3 MEMBER BROWN: Okay. I'm familiar with him.
4 CHAIRMAN SIEGEL: Someone who has previously 5 had I 131 therapy.
6 MEMBER BROWN: Right. 'And, actually, I read 7 something that he had written previously in talking about 8 his experience about being released and going and picking 9 out tomatoes at the supermarket and no one telling him not 10 to, that kind of thing, and then feeling horrible about --
11 CHAIRMAN SIEGEL: That's his hang-up, Judy. I 12 mean, the truth of the matter is if you make careful 13 measurements in the houses of people who have been treated 14 with I 131 and then you do thyroid bioassays in the family 15 measures, you do not ficd doses that are worrisome in any 16 way, shape, or form.
17 You've got to base this on what's practical.
18 We can't reduce these risks to zero.
19 MEMBER BROWN: .See, but what bothers me, Barry, 20 is that your saying "That's his hang-up" doesn't help me.
21 I'm just hearing from the same side of the issue 22 cons t ant ly . TM;when;we;have Wind Eof G aWenegade , Tan; NRC 4 23 tiawye rRetuneone7;who 'l has ihad; t he a t reatmentr;whoeverghe li s',
24 whp&saysothatschissier ar different comunentna .different
.,y 25 gpinion anddfoP9eB"E6"dfhhifisTiFa583,a, c ,.,",.nurg#9 "That's his#
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. 341 1 'hlanh5 uk* ItS5t!%d55rIEEMElpIliMfE 2 I'm the only one here who is supposed to look 3 at it from a really, really different perspective.
4 CHAIRMAN SIEGEL: I understand that.
5 MEMBER BROWN: So I'm looking for some help 6 here. I really don't want to just rubber stamp --
7 DR. WAGNER: What would you like to know, 8 Judith?
9 MEMBER BROWN: I'd like to know what other 10 people who are not in the medical community that have those 11 cost considerations primary in their mind think. That's 12 what I'd like to know.
13 CHAIRMAN SIEGEL: Could I make a --
14 MEMBER FLYNN: Well, as someone from radiation 15 oncology who doesn't have the nuclear medicine cost 16 considerations in mind, I agree that I think the NCRP 17 report, I think the dose may be close to 350 millirem a 18 year if you count radon, almost one millirem a day that we 19 all get, almost a millirem a day we all get.
20 If we live in Denver, I think, as opposed to 21 Boston, Boston being at sea level, I think it's close to 20 J
22 millirem a year in Denver or thereabout, something like 23 chest Xrays a year more.
24 DR. WAGNER: It's more like 100 millirem a year 25 more.
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, 1 MEMBER FLYNN: In Denver?
2 DR. WAGNER: Yes.
3 MEMBER FLYNN: Okay. And a trans-Atlantic 4 flight, I think, is five millirem. So it's like saying 5 "Should we worry about this or should we worry about 6 individuals making 20 trans-Atlantic flights and should we 7 have warnings to get on airlines because these doses are 8 getting into the noise levels of what we're getting every 9 day and what the public gets every day depending on what t
10 geographic region of the country they live in?"
11 Some places of the world they're getting 10 and l 12 20 times that dose because of the natural background in 13 that part of the world. So we're really in the noise 14 level, I think.
15 So I would agree with Barry in this issue l
16 completely.
17 MEMBER BROWN: I guess also there's a minor 18 distinction to be made between things that you undertake,
! 19 you choose to live in Denver, you choose to get on a plane, 20 versus things that are done to you.
l l 21 And if the consequence of something done to you 22 has an effect on your family, that may not be communicated 23 to you adequately because you're not listening, because the 24 person is not communicating very well, even though they 25 think they are, the health provider, because you don't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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343 1 speak English but you're pretending that you do. So you 2 smile and you nod. I'm worried about that kind of thing 3 about a procedure being done to you.
4 CHAIRMAN SIEGEL: But there have to be 5 consequences.
6 MEMBER FLYNN: There's no risk.
7 MEMBER BROWN: I'm sorry?
8 MEMBER FLYNN: I don't think there's any risk.
yw: ,
,c , , , , , , , , , , , ,
9 CHAIRMAN SIEGEL~:YThere ~ h, ave t...o. ib_e.
w- .
10 "consequencesg 11 MEMBER BROWN: C.Yoti'reisayinguthere g havertaibe 12 con'seqdericssh 13 CHAIRMAN SIEGEL' Cyes 3%
14 MEMBER BROWN s And~you'reisaying:thereisJo.
15 t riskL 16 CHAIRMAN SIEGE}.,$ Thah' U hat Lwe'reL-saying.w I-17 nean'i?;we're?sayindworry5n}'ab6utTthelriskVbetweenJ100and 18 1500 millirems' to; members; of;the fgeneral publicE.~AEd 19 "particularly.L to; f amilyImembers, Jisl something.; weishoi.tidntt 20 N-wofryling 5156ut'.
0 1
i 21 MEMBER BROWN: Barry, are you saying " Trust j 22 me"?
23 CHAIRMAN SIEGEL: No , I'm not saying trust me.
24 I'm saying trust a large accumulated body of scientific 25 knowledge, none of which I participated in generating. I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l
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. 1 also saying we've got to be able to take care of patients 2 in an expeditious way.
3 EI! couldrit ta care zless ; abouta the y costggJ t; 4 doesnitroostrmetaalottoftmoneyatogcreate;the: record q uhat , _
9 5 '
"i%Wooes Fth6figh?ia:1tvcreatesta:high; anxiety;1evelcinithe
- T i 6- " people who aEs?weskTngWIt creates,a~high:,;anxietiyf l evegig r 71 thelpat'ientitoTatartlgetting2 instructions;about 3 risks;t_ hag 8 'dori'sedisDEThat.rsiimportiMB 9 And I think people should be instructed. I 10 think people should understand what's going on. I don't
- 11. think people should be made crazy by the process of being 12 released with radioactive material on board when they don't f
13 pose a hazard to the members of the general public.
14 MEMBER BROWN: So they should go home and hug 15 their kid or not?
16 CHAIRMAN SIEGEL: Sure, sure. But, I mean, 17 Judy, what I tell people is I say "I'm letting you out of 18 the hospital. You just got treated with I 131. You should 19 not stop taking care of your child. However, here's what 20 you should do. If normally you would watch ER with your 21 child," which I did, by the way, last night --
thank you
~22 for the recommendation.
23 MEMBER BROWN: We'll have that discussion 24 later. ,
1 25 CHAIRMAN SIEGEL: -- "with your child sitting NEAL R. GROSS j COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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345 1 on your lap for the hour, for about the next week or two 2 weeks, what you ought to do is just have your child sit on
'a the other side of the room. It's prudent thing you can do.
4 It will lower an already low dose and make it less. Don't 5 disrupt your life. Don't do things that are crazy."
6 Let's see. David Woodbury first and then Dr.
7 Pollycove.
8 DR. WOODBURY: There are studies, Judy, that 9 look into this. I don't have the reference, but there's a 10 Dr. Jacobson in the School of Public Health, University of 11 Michigan, who has done just that for patients who have been 12 treated for thyroid things, I 131 for hyperthyroid, I 131.
13 He went into the homes and took measurements and saw and 14 found the exposure to family and so on was negligible.
15 And so I think that data is available. I don't 16 have the precise reference, but it could be gotten.
17 CHAIRMAN SIEGEL: Myron?
18 DR. POLLYCOVE: It would be useful to know that 19 throughout the world, and particularly in Denver since we i 20 mentioned that, but other places that are high altitude, 21 where the background level is 50 to 100 MR per year, some 22 places even higher, and people have lived there in other j 23 parts of the world for many generations and in Denver their 24 lifetime, that all of these places have demonstrated a i 25 lowering of incidence of cancer and leukemia and a lowered NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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346
. 1 mortality rami 62tMt'.?cllzof;the g egidemiologi_c; tag 2 DidP have' been a made ain c theseWrsa s*have7all demonstratMg 3 notionlyanoxeffecta butaatpositiveaeffeet.
4 Now, you say "Well, why, then, these scientific 5 bodies, are they so conservative and come out with these?"
6 Because it's the political legacy of decades. I mean, 7 that's the scientific data.
8 MEMBER BROWN: So it's just historical reasons?
9 DR. POLLYCOVE: Not historical. Scientific 10 data. Historical is the linear no threshold hypothesis, 11 which is being increasingly under attack. We had an entire 12 all-day meeting at the American Nuclear Society showing 13 current data which shows either zero effect or beneficial 14 effects if there's enough radiation.
15 For example, in the Canadian fluoroscopy study 16 that was published in the "New England Journal," it was 17 shown that women who received 15 rad to their breasts when 18 they were in TB sanitaria had two-thirds of the breast 19 cancer mortality of the controlled group, who had no 20 radiation.
21 Now, 15 rad is 15,000 millirem. And we're i
22 talking about 100. Now, if women knew that a third of them 23 would not have breast cancer if they were exposed to this, 24 I think that would do more good than mammograms.
25 MR. SCHNEIDER: Just for the record, four NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W.
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' 347
. 1 comments. Number 15 was from the Ohio Citizens for 2 Responsible Energy. Number 25, Peter Crane --
3 MEMBER BROWN: Ohio Citizens for Responsible 4 Energy. That sounds like a front for a something group, 5 for an industry group.
6 MR. SCHNEIDER: Number 25 is from Peter Crane.
7 MEMBER BROWN: Does anybody know anything about 8 that?
9 CHAIRMAN SIEGEL: About what?
10 MEMBER BROWN: Ohio Citizens for Responsible 11 Energy.
12 CHAIRMAN SIEGEL: Not a word. Bob does?
)
13 MR. GJILLIN: The Ohio Citizens for Responsible '
14 Energy is a group in northeastern Ohio who's primarily i
15 interested in the Perry Nuclear Power Plant. j 16 MEMBER BROWN: Okay.
17 MR. SCHNEIDER: Number 42 is from the Clean l
l 18 Water Fund of North Carolina. And Number 48 was from the 19 Nuclear Energy Institute.
20 MEMBER BROWN: Thank you.
)
21 DR. PAPERIELLO: This is Carl Paperiello.
22 Could I make an observation?
l 23 CHAIRMAN SIEGEL: Go ahead.
24 DR. PAPERIELLO: The NRC would not be 25 considering this at all if there were not, shall we say, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W j (202) 2344433 WASHINGTON. D C. 20005 (202) 234-4433
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348l
. 1 international and national groups which have established 2 the standards that we essentially work into a regulation.
3 That?a ourtproblem,utrying $5! J ake~what1has t
4 been established byythe scientific communityiusing Ahe 5 linear dose hypothesis.,; the maximum risk,i BEIR .V,1 the.;whole l
.-.nine.-yardsr. and trying:to make a_ regulation out of.;aa, 6 1 7 ' recommendationg.That's my_ problem, trying j to mov 8 something# from
-.,..shalh
,a we say, a scientific recommendation, 9* into'a.. legally binding requiremen$ And that's where what 10 is nice -- you start taking gray and making it black and 11 white.
12 Basically what is said by ICRP in publication 13 60, which is their latest set of standards, -- that's the 14 International Commission on Radiological Protection -- the 15 NCRP, I think, 116, but one of the latest ones, as well as j 16 the IAEA and World Health Organization, -- there are about j 17 six different organizations that support the international i
18 radiation protection standards -- is this: one, the public 19 dose should be limited to 100 millirem a year. And they 20 mean that as you design your program if you're using 21 radioactive material that members of the general public --
22 you don't know who they are, anybody -- is 100 millirem a 23 year.
24 However, they all state that in the case of 25 exposure of patients, the nonoccupational voluntary NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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, 1 care-givers of patients, their exposure is considered 2 medical exposure. And it should be constrained to 500 m
3 millirem a year. That's IAEA.
t 4 ICRP basically uses very, very similar words.
5 The National Council on Radiological Protection and 6 Measurement says that for an occasional individual to get 7 500 millirem on occasion is acceptable. I'm paraphrasing.
1 8 I don't know the exact words.CT @ ldsUli M 0doditzwss6 9 toneCindividual toigeti500!aillirem;yearliniandlyearlost!'.
10 It's not very likely that you are going to be 11 involved in a situation where you have in this case a 12 family member getting radioactive material that you are 13 going to get 500 millirem every year for your entire life.
l 14 %It ! s Lj ustran! episode ;that3 happens;a : couple; of Etines 2 atlmost t
l 15 likely~zin3youna
.- ~..
rl ife,
.n time. -
l 16 Those concepts that are in those publications 17 using the linear dose hypothesis arguably -- maybe it is l
l 18 ultra conservative. Maybe it is unjustified, but it's
- 19 certainly been the hypothesis or the theory that has been 20 supported by the BIER Committee of the National Academy of l
j 21 Sciences, the EPA, and similar organizations. Using even i 22 that theory, they're establishing 500 millirem as a 23 constant level for occasional circumstances.
24 That's what we're dealing with right now. How 25 do I take those recommendations and work them into a ,
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~
l 350 1 regulation where I understand the recommendations, but l
l 2 they're gray? And now the minute I move them into a 3 regulatory area, everything has to be black and white.
l 4 That's just what law does to you.
5 So the NRC is not making this up out of the 6 air. We're doing it because it is consistent with the 7 international recommendations. And I had my closest 8 counterpart in England over here in May. And I asked them l
9 what they do. They basically do what we're proposing to do 10 here.
11 So we are not an outlier in the international 12 community. That's all I could --
13 CHAIRMAN SIEGEL: And, Judy, just to add one 14 more bit of historical perspective that's important, 15 remember that the reason we're having this discussion from 16 the beginning is that when new Part 20 went into effect, l
17 this slipped through the cracks as a gap that the new Part l 18 20 failed to address explicitly so that it appeared that l I
19 current practice was now being outlawed because current 20 practice, current 35.75 that says you can release patients
! 21 from the hospital when their body burden is below 30 i i
22 millicuries and when their dose rate is less than 5 l 23 millirems per hour at a meter was predicated on 24 longstanding NCRP guidance to limit exposure to a member of l 25 the general public to less than 500 millirems in a year.
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351
, 1 That was the idea behind existing 35.75. Part 20 appeared 2 to create a conflict.
3 What we're trying to do by way of this 4 rulemaking,.what the NRC is trying to do in response to the 5 petitions is to get back to current practice, which has 6- been in place for years and years and years and which no 7 one considers to be unsafe. In the process the NRC created 8 something that turns out to be more complicated than it 9 needs to be to protect the public and to allow patient care 10 to go forward.
11 MEMBER BROWN: Okay. So the only sticking 12 point, then, should be the breast-feeding.
13 CHAIRMAN SIEGEL: Well, no.ES $ Eg$ M I M 14 is;whether;you2really; peed!tsidolanythimeliEthe2mme;
., . n n - ne , m - a n n. n , ,-
15 i betwees;100;milliremsland>500#milliremsdandiwha ,tet E.,_poper 16 atrai12haaf tMbeXissolWiNIDIUEEsfyE5ehisFtshstJandithoniche 17 i potentialfingiacE6rIth5E 5a$EUIAddiliief b tisicosEMbif."majer,1 18I 'stil51iih [pbl E AT And we'll keep working through those.
19 Now, let's see. Dennis or Buzz had a comment, 20 too.
21 MEMBER NELP: Well, I was going to comment on 22 the problem, the question regarding how you're going to 23 solve the problem. I don't want to comment any further on 24 the question. I think that's --
25 CHAIRMAN SIEGEL: Okay. Dennis?
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. 1 MR. SWANSON: Just to remind you. In the 2 proposed rule, there was a requirement that you document --
3 the release criteria was 500 millirem, below 500 millirem, 4 but there's a requirement that you document anybody between 5 100 and 500 so that you could look for if they had multiple 6 exposures that they didn't exceed the 500 millirem per 7 year.
8 I don't really have any problems with 9 documenting a single release criteria that the patient fell 10 below 500 millirems per year. Where the problem comes in 11 is trying to keep this running total if they got multiple 12 administrators. The problem is to do that assumes that the 13 patient is going to get all of their radiation therapy at 14 the same site, Point Number 1, which is not reality. Okay?
15 Point Number 2. Let's assume that a patient 16 got an iodine 131 thyroid treatment. We released them at 17 the limit, 500 millirems per year. And for some reason 18 that patient needed another therapy.
19 Are we going to say or refuse that therapy 20 because that patient would receive an excess? Well, no.
21 We can give the therapy. We'd have to keep them in the 22 hospital -- okay? -- and not release them, but then the 23 cost increase and, in fact, patient's insurance provider 24 may not cover that increased cost of requiring to keep them 25 in a hospital.
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353 1 So those are some of the issues that you get 2 into. And it basically deals with keeping track of the 3 running total, what you have a problem with.
4 One other comment here. I see this 5 performance-based rule. And after our_ discussion 6 yesterday, an alarm goes off in my head whenever I see the 7 terminology " performance-based rule." I don't know if you 8 were here yesterday, but you might want to go back and 9 review the minutes on that.
10 DR. WAGNER: I'd like to point out that if you 11 do release someone at the 500-millirem level, okay. Fine.
12 They come back for another treatment. You've got a big 13 problem now because you released them at the 500-millirem 14 level the first time. You can't give any more above the 15 500-millirem level, period.
16 What are you going to do, keep them in the 17 hospital for the rest of the year? You've got a problem 18 there.
19 CHAIRMAN SIEGEL: That's actually not true. I 20 mean, the numbers that are in the current tables, one of 21 the problems with them is that they're really fairly 22 conservative numbers. Titey;dolpot2 consider!.a_tt M qm_.
23L .CorsectTL Jtewarth 24 MR. SCHNEIDER: t$ tight 25 CHAIRMAN SIEGEL: So they ignore attenuation.
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, 1 They have assumptions about occupancy factors, the 25 2 percent tandem human being that may not be realistic for a 3 substantial fraction of human beings that we are going to 4 be taking care of.
5 So one of the things we discussed at the 6 meeting in October, A M acussione-in-October 7- wa s-t ha t-7 areating-a-much-larger series of-tables-that-address-e-8 ~ variety-of-these-other-issuest-such as-what-the-Teal-uptake 9 -factors-and-excreticri rates 7---because-excretion is.baing 10 ignored-in-the-firet-24-hours-in-these-tables-as well. -
11 excretion-rates 7-bioclearance-rates,-attenuation 12 If we start getting into tables that more 13 realistically reflect the truth, you can start calculating 14 these numbers down to give you much, much wider latitude 15 and still be doing something that's perfectly safe.
16 This is not playing with the numbers.-s1 Names 1'
- W'*E*?l* W NY'*kWLW W & W" 18 ;fivetthat are in these tables when you start adding in most 19 of the other considerations, the real factors.
20 DR. WAGNER: And it's very important, though, 21' that that get corrected because if we don't get that 22 corrected, then there's going to be a lot of problems with 23 regard to that kind of level.
24 CHAIRMAN SIEGEL: So the concept kind of was 25 " Fine. Create a table that says this is -- ignore the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE tSLAND AVENUE, N W.
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, 1 regulatory space between 100 and 500 millirems because 2' you're ignoring it now. There's no reason in the world to 3 worry about that regulatory space "
4 And that was the concept where a cost / benefit 5 analysis would show that the extra work required in 6 fretting about that 400-millirem gap wasn't worth the 7 effort in terms of the public health and safety. Then 8 create a comprehensive set of tables that let licensees 9 know where those 500-millirem limits are.
10 And then when people have to come back and be 11 re-treated if they're at the margins, that's the point at 12 which the licensee has the responsibility to gather as much 13 data as he or she humanly can about what else has been done 14 during the course of the last 12 months to this patient and 15 then really look at the factors in that person's 16 environment to try to decide what kinds of doses were 17 actually laid out to. members of the public.
18 wItcalsoIturnsjout;thatsthe; number sofimu.l.tiple. i 19 edministrationarisiralativelylsmalh And certainly the 20 number that would likely take you over the 500-millirem I
21 limit -- for some reason, I'm having trouble finding my
_n...- - gmvmaw, a4 22 data.fstewart7."dospoubhaveisyxnote;2bm ydig$y!? Mg , , ,
23 MR. SCHNEIDER: Not with me. ,
24 CHAIRMAN SIEGEL: You don't have it with you? ,
25 At Stewart's request, -- I must not have put it in my NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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, 1 package - r3centheredAhe u,dpta from our 2 ho,ppitals maammaan nommfor a ~7 2 42-monthaperiodsanda looyd;1ataallsofmtherpatisnts.uwhg
- 3. groookvedgMi@wceut.icalm therapy xorrIe132:a f orz t hyroid; 1
4 cancerIlmog Hiig,"EsoTwritWriTdi riect iveTooses"W l 5 Yadiopharmaceutida17 mist!TookedEatithe:numberiwho3had; hag 6 gsJdone'dur unaltip1E~ti,d,n,na..rw wring" the" year.uwx mm And3itE. turned l outg g 7 q be;a;veryssmalltfrectilonTof Ethertotal? cit wabTwellTUiidsf we, m smepams%,,,,,
8 0 percentj wasn8tiit? l 9 So that when you reduce the recordkeeping 10 burden to worrying about that fraction of the patient 17 population, it becomes a much more practical rule to work !
12 with and much closer to what is currently in place, which i I
13 makes sense and has worked for 20-plus, 30-plus years.
i 14 Buzz?
15 MEMBER NELPg I 1 presume?wefre s talk,ing j l
16 exclusively abouty n c:wn ,t-131r I
therapy;at3the;;.presentltime. I y x. -
17 mean, there's no other therapy that we give that exposes 18 the public that I'm aware of. Isn't that correct?
1 19 CHAIRMAN SIEGEL: "AtithatIpreuntitime77that?ig l 1
~
20 correict.4 I mean, there is --
21 MEMBER QELP:...I,gmean,nthere's;nos other. approved
{
22 ,use,of ta;radiopharmaceuticalr for; therapy thstradassathisa )
l 23 exce , pt_3 so_luble ;;I;131; f or. thyroid ; therapy .
, . . m I think that's !
24 correct. ,
25 CHAIRMAN SIEGEL: At the present time, that's I
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i
357
- j. ,,
. 1 correct sC311ongfaslyoulcontrol acc;blit3:c paticntjs;ur,ine -
2- "afthr?a"stro'ntiumE891therapye 3 MEMBER NELP: Yes. And I don't know the number 4 of people that are treated each year in the United States, 5 but it's a very small number overall compared to the 6 population.
7 CHAIRMAN SIEGEL: Carol always used to spout 8 those numbers. There are about 100,000 I 131 therapies.
9 MEMBER NELP: No, no. It has to be much -- no.
10 It's quite low.
11 CHAIRMAN SIEGEL: For hyperthyroidism?
12 MEMBER NELP: I would het for a population -- I 13 don't know the number, but it's relatively small.
14 CHAIRMAN SIEGEL: It's a few thousand for 15 thyroid carcinoma and 50 to 60 thousand for 16 hyperthyroidism. j 17 MEMBER NELP: There's no problem with treating 18 hyperthyroidism, but for treating thyroid carcinoma with 19 larger doses, I don't know the number, but it's very small. I l
20 CHAIRMAN SIEGEL: Right. We have the numbers 21 here.
22 MEMBER NELP: And you have subsets of the 23 population that you identify all the time that get 24 different types of radiation exposure. For instance, the 25 occupational workers are a subset, and they come under NEAL R. GFM3SS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (2Q2) 234-4433 WASHINGTON D C. 20005 (202) 234 4433 j i
i l
358
, 1 special guidelines. And they're a subset of people who are 2 going to be exposed to these patients. And that's going to 3 be a very small portion of the population.
4 Is there any way looking at it from that point 5 of view and saying "The average patient doesn't really 6 expose the population at all," it's average patient may 7 expose 5 or 6 people or 10 people, -- you inferred you had 8 some numbers on that -- and say "Look, this really is not a 9 population problem. This is a medical problem, which is a 10 subset of medicine," and try to avoid the --
11 CHAIRMAN SIEGEL: That's effectively what's 12 being done.
13 MEMBER NELP: -- try to avoid this complicated 14 general public impression?
15 CHAIRMAN SIEGEL: That's effectively what's 16 being done is that an exemption to the hundred is already !
17 in existence and now needs to be patched into place --
l 18 MEMBER NELP: Well, but look at the occupation.
19 The occupational worker --
20 CHAIRMAN SIEGEL: Well, Buzz, I agree with you 21 completely.
22 MEMBER NELP: -- theoretically can get 100 mr 23 per week. Isn't that correct? I mean, that's not --
24 CHAIRMAN SIEGEL: Correct.
25 MEMBER NELP: That's for your information. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W
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, 1 can receive 5,000 mr per year for my working lifetime. I 2 wouldn't, but it's permissible. Anyway, I just wanted to 3 interject that concept, and you've probably already thought 4 about it.
5 CHAIRMAN SIEGEL: That's really what the 6 concept is. The concept is that this is a special case 7 that involves exposures to small numbers of individuals, 8 many of whom have a stake in the patient's welfare.
- 9. And, consequently, that warrants the exemption 10 to the general population limit. That's the whole 11 philosophical basis to having this in place in the first 12 place.
13 MEMBER NELP: I would like to say one other 14 thing. I understand what you're saying, and I agree, but 15 if it is true that you've put into some sort of format for 16 others to view the projected exposures to a person's body 17 or from a person's body and they're four to five times over 18 what they should be, I think those should really be 19 calculated and put down into reality because that will save 20 a lot of time and trouble if that's true because if you put 21 those tables out, they're going to be referred to. J 22 CHAIRMAN SIEGEL: Absolutely.
23 MEMBER NELP: And I think if they're a factor 24 of four off, they should really be trimmed down. That will' 25 save a lot of time and effort for those people who have to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 W ASHINGTON, D C. 20005 (202) 2344433
i 360
. 1 get involved in it.
2 MR. CAMPER: One comment on your comments, Dr.
3 Nelp. l 4 MEMBER NELP: Maybe you've already thought 5 about these.
6 MR. CAMPER: Historically the 35.75 release
! 7 criteria has had an implied limit of 500 millirem. The j 8 language in the proposed rule makes the 500-millirem limit 9 absolute. This is for medical procedures.
I l .10 So, in fact, this is embodying the very thing t
! 11 that you're saying for medical procedures. The dilemma 12 comes when we start to deal with the issue that Carl 13 raised. And that's the fact that we have this 100-millirem l
l l 14 limit to an individual member of the public.
1 15 And that's what we're wrestling with. What 16 should we do, if anything, between the 100 and the 500?
! 17 MR. McGUIRE: Could I make a comment, too, on l
18 this issue of the conservative factors that are built into 19 the table of releases in the regulatory guide?
20 A guide is not a regulation. It's not a 21 requirement. It's just listed as an acceptable way of 1
22 doing things, but it also says that it is acceptable base l
! 23 of release on a case-specific calculation. So that there t
24 is the option in a performance-based rule to do something 25 that's a little different than the table if you can justify NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVENUE, N W.
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361 e 1 it in your particular situation.
2 CHAIRMAN SIEGEL: Nonetheless, I think when we 3 discussed this a few weeks ago, we thought that letting the 4 NRC do a little bit of the homework and come up with a 5 complete set of tables that incorporated various different 6 assumptions that one might pick and choose from would be a 7 great service to the community at large and probably would 8 minimize the frequency of errors in calculation.
9 DR. WAGNER: One of the difficulties with just 10 leaving things in a guide, too, is the fact that if you do 11 the calculations and an inspector disagrees with what your 12 assumptions were, you've got a problem now.
13 Now you've got to work things out. And that's 14 always a source of disagreement. We really need more very 15 specific guidance.
16 CHAIRMAN SIEGEL: It might be.
17 Kitty, continue.
18 MS. DRAGONETTE: That's a little bit of damned 19 if you do and damned if you don't.
20 (Slide) 21 MS. DRAGONETTE: The second issue, which was 22 not as big a deal but is related also to this zone between 23 100 and 400 was the proposed rule had a requirement to give .
24 written instructions to the patients when you were 25 releasing them if the estimated doses would be greater than ]
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- l l
362 l 1 100 millirem.
2 And there were comments that we got that we 3 should not specify that they should be written, that they 4 should have the option of doing written or oral. There was 5 support for requiring the written directions. And there l 6 was concern expressed about the fact that patients don't )
7 always do what their doctors tell them to.
8 (Slide) 9 MS. DRAGONETTE: On this issue, the options --
10 and at this point we're still debating them -- are leave it l
l 11 so it's just instructions so that oral would be sufficient, l l
12 go ahead with the proposed requirement to require the 13 written instructions, but emphasize and explain again and 14 in more detail in the regulatory guide that explaining 1
15 things and walking a patient through the directions and the 16 assumptions on the behavior that you factor into ;
17 demonstrating that you meet the dose limits, that if you do 18 those things, that's a reasonable way of meeting it. You 19 aren't responsible.
20 s...I meannwe've talked:aboutl.this before, abut;the 21 :physiciantwouldinot;betrespons'ible^ifithe; patient 22 intentionally;did:notrfollow;tthe. direct,ionstand 23 <
'iuggestliftife r So those are the options being considered on 24 that one.
25 MEMBER BROWN: Do you want feedback on that or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUS, N W.
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s 363 e
1 do you just --
2 MS. DRAGONETTE: Yes.
3 MEMBER BROWN: Just from my opinion, there 4 would be no way I could be argued out of the position that 5 written instructions should be given. So don't try.
6 MS. DRAGONETTE: Certainly from my own personal 7 perspective, when I've been a patient getting some 8 procedures or something having something written to refer 9 back to is helpful.
I 10 CHAIRMAN SIEGEL: Right. But let me go a step 11 further.
12 MEMBER BROWN: Are you going to try? !
13 CHAIRMAN SIEGEL: No. I'm not going to try to 14 talk you out of it. I'm going to try to tell you that 15 seeing written instructions is insufficient.
16 MEMBER BROWN: Oh, yes, sir.
17 CHAIRMAN SIEGEL: Okay. And, actually,Ifst'?the >
18 meeting.in OctoberiawePsuggested:the;conceptythat;what" 19 proposed?35.'75 (b)'(1): should,sayjis .it should say " provide 20 tthe pstient' witE i'nstructions,Ci'ncluding" written 21 < instructions,?on how to A ntals doses:to,otheryindividuals l
22 ,asr low as reasonably; achievable"olest.. thedicenseels.
23 gesponsibility-:isiperceived:to;.bef"Here. Read this."
24 MEMBER BROWN: Right. I assumed that verbal 25 was a given.
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+
1 CHAIRMAN SIEGEL: The way it reads here --
~
2 MEMBER BROWN: So I think you do have to spell 3 that out.
4 CHAIRMAN SIEGEL: The way it reads here --
5 MEMBER BROWN: I appreciate the addition.
6 CHAIRMAN SIEGEL: Do the rest of you agree with 7 that? I mean, this really is something that you shouldn't 8 -}ust give them a pamphlet and say "Go home. M .
9 y is;something1thatMAIk'irig W tihemIis' i nere limportantith 10 r
the_ written
+;;;w. - - - in structions,
--a 11 The written instruction sort of is a backup 12 when they get home to say "Now, what were those 300 things 13 that Dr. Siegel told me about?"
14 DR. WOODBURY: We try to abide by written 15 instruction in the " Federal Register" and have trouble.
)
l 16 CHAIRMAN SIEGEL: We've noticed. I i
17 DR.-GLENN: I wonder if I could pose a question ]
18 to you. Is that for all procedures? EhhMs5Eihtf& hat 19 you-would7 say; require 2instructionsZonlylforzthosegg sk(
p 204 procedures."thate_re_. quire'a1 written. . =dir_ec.tive?" Whatuisithe i3
- m. - - .- -
m-a.,
i 21L Committee *Isenseio'~%Ifiit? n 22 CHAIRMAN SIEGEL,;7.My; persona ( preferengg ,
23 depend..ing > on: how we"lget"intoT t}1elbreastufeeding:"part':ofa 4 __. _.
24 this5would be7 t o+11terally'tietthis.wholeithing;totthose 25 proceduresethat-involve.:.writtenTdirectives"andinotito get; NEAL R. GROSS COURT REPORTERS AND TRAN$CRIDERS 1323 RHODE ISLAND AVENUE. N W (202) 2344433 WASHINGTON, D C, 20005 (202) 2344433
365 1
invol.ved, u - ~ - mwithm m sthis,fo_r
.c m m. disgnost.
m mm ic ,im_ aging,y therkindcofe m - - -
i 2E 'dii@ii6eifFisiffngFthilS. ^does?notccurrentlya requirena U writtentdirmabigny 4
4 I mean, again, this goes back to the whole l l
5 series of discussions we had at great length with respect 6
to the quality management rule. CWat'fyod'santrto"dc71FW3 7
really1want*to; focus peoplef aeattentionfon'those~f thihiigs a ethat; create;a; risk.
9 And if you get them spending all of their time i
10 working on things that are not a risk, then you divert l
11 their attention from the important ones, and then mistakes i
12 get made with the important ones.
13 What you want to do is make sure that people 14 who -- in the case of radiopharmaceuticals, you want to 15 make sure the people who are getting I 131 who not only l 16 pose a external radiation hazard to the world at large, but 17 also our leaky sources understand what's going on.
18 You, on the other hand, don't particularly need 19 to get carried away explaining to someone who had a bone 20 scan what they need to do for the next 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. That's a 21 waste of time. And if you spend your technologists' time 1
22 and your time doing that with bone scans, you'll end up 23 doing a less good job where it 's important because you 24 won't have enough time. That's resource allocation.
25 MS. DRAGONETTE: Okay. The other sticky is:
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How should the breast-fed infant be addressed in this 2 scheme and then worrying about the 100 and the 500-millirem 3 dose limit?
l l
4 Dr. Siegel has mentioned if at the 500-millirem
)
5 limit per se breast-feeding is not interrupted or 6 discontinued, you could pick up some of the diagnostic 7 patients. It's the radiopharmaceuticals where it doesn't 8 localize in a specific site things that generally circulate :
9 like pertechnetate or the iodine 131. ;
10 As far as the comments go, a few, the two major 11 points, one was that the individual likely to receive the 12 highest exposure should not include the breast-feeding 13 infant. And the other one was that that should be a 14 patient-physician decision.
15 (Slide) 16 MS. DRAGONETTE: This issue is somewhat a 17 generic issue of how to approach the breast-feeding infant.
18 It represents unique circumstances. There are basically 19 two points of view, I believe, in thinking about it: the 20 radiation people, such as myself and Carl and the staff 21 here at NRC, who are worried about that infant or child as 22 an individual and consistently applying our radiation 23 protection equitably; and the other is the 24 patient-physician standpoint, where they want maximum 25 flexibility to make the best decisions for the situation at NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W-(202) 234 4433 WASHINGTON. D C. 20005 (202) 2344433 J
367 I hand.
_., 2- So our problem is to try to reconcile or l
3 balance those two or-figure out ways to accommodate them. ,
4 (Slide) j
. l 5 MS. DRAGONETTE: I'd like to go over a little 6 bit of the perspective from the radiation protection 7 because this is the direction-we on the staff are leaning,-
8 our rationale and what's behind our view that the infant l 9 should be considered. '
10 First of all, the infant is physically 11 separated. The situation is different from the 12 embryo / fetus. Clearly the child is separate and.can I
i 13 survive and there are alternatives. I L
J 14 And the child is not receiving any direct t I 15 benefit from the radiation. The woman is, but the infant l li 16 isn't. The benefit the child is getting is from the milk, i
17 the biological benefit, but not any benefit from the i 18 radiation exposure. And that's one of the basic tenets of l 19 radiation protection, you know, that --
20 CHAIRMAN SIEGEL: So you're saying that a 21 healthy mother is not of benefit to the infant? l 22 MS. DRAGONETTE: A direct benefit. Obviously l l ..
23 --
24 MEMBER BROWN: Excuse me?
25 MEMBER FLYNN: It was a direct benefit in my NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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- 368 1 case.
2 MEMBER BROWN: How did you get that?
3 MS. DRAGONETTE: Obviously the mother's health 4 is important to the child.
! l 5 MEMBER BROWN: I think you're reaching. j 6 CHAIRMAN SIEGEL: No, I'm not reaching. Judy, 7 don't misunderstand me. -hhh hNNh M 3 8 Edi'acussionsIthatT I "dodit'6onsi~defHti7cjdod7piihtilce30
., ,a-,,m~,,.n,,..
9 .ir,r ~diate"inf a ant s ; wit 1E, milk .
10 I}ut ,3. on~ theXother: hand;Lthere "are: circumstances 11 1 in?which^ ITsould?allosTAFTnfaht T tio Wisadiat'ediwhensit l
- -rw. ,-~ ~we. . . -
12 Jivas7;in5tlwnbestrintereste of"both there ' infant-"and the 13 .mc$hergandatheimedicali cars;ofnthenmothgr.
14
- They ' re r f ew7 arid ? f sF between znThey ' re tnot;manf 15 But I don't want to make myself crazy with paper trails to 16 achieve something that occurs, first of all, very .
17 infrequently and might conceivably interfere with medical 18 care. .
.m 19 But let's keep working through this.
20 MS. DRAGONETTE: Another consideration that we J
21 have is that all infants and children don't breast-feed.
22 So you would have one level of protection for the -- you l 23 could have same-age children or infants or twins and one 24 breast-fed and one didn't. One you would have to evaluate l 25 and protect to the 500 jer year. The other one there would
! NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l
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1 be no limit. So intellectually that is very difficult for 2 us.
3 And, in fact, my sister had twins. One was 4 allergic to milk, and the other one wasn't. It's not an 5 abstract situation to have same children in the same I
6 household.
7 Another point is that if after birth the child 8 is not considered an individual to be protected, then if 1
9 you're going to base it on when they stop nursing, that j 10 varies. I mean, they can nurse for weeks, months, years.
11 So that's another logic problem we had. ;
12 A fundamental tenet of radiation protection is 13 to optimize things so that you get the benefit of the well 14 mother at the least dose or the least reasonable dose to 15 others.
1 i
16 A practical consideration is related to that j 17 the child is separated. And quoting virtually verbatim out 18 of the statements and recommendations of the American 19 Academy of Pediatrics, before you do a nuclear medicine 20 study or particularly one of these therapies, at least for 21 certain diagnostics, if we get into the diagnostics base, 22 the mother could pump the milk and store it in the freezer i
23 and feed the infant her own milk during an interrupted 24 nursing.
25 Now, with the directives and the therapy, it's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON, D C. 20005 (202) 234 4433 i
370 1 very difficult to resume nursing with the iodine 131. But 2 for other --
3 CHAIRMAN SIEGEL: It's impossible.
4 MS. DRAGONETTE: Or impossible. But that is a 5 consideration on this issue. I mentioned the American 6 Academy of pediatrics, but in other things we've looked at:
7 the American College of Radiology recommendations; the 8 Society of Nuclear Medicine, who essentially puts the 9 burden in the direction on the patient about interrupting 10 nursing; the U.S. Pharmacopoeia; FDA guidance; and we've 11 also already mentioned ICRP and NCRP. So there are many 12 groups that address the nursing infants.
13 Many of these medical groups are failing the 14 100 as a recommended level for what acceptable doses are 15 for when you could resume nursing. In our formulation, the 16 level is 500, but we in radiation protection are not out 17 there all by ourselves on this one either. The medical i
18 community also recommends this is good practice and that 19 should minimize the impact. But philosophically is what i
20 I'm talking about here.
21 (Slide) 22 MR. SWANSON: Excuse me. The rest of the 23 medical group considers it also good practice to not give a 24 lot of drugs, including chemotherapy agents, et cetera, to 25 breast-feeding mothers. But the difference, I think, here NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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1 is that you don't have to have the documentation trail of 2 that. Again, it's good medical practice.
3 MS. DRAGONETTE: On that previous slide I did 4 mention, but I didn't say that these principles apply to 5 other drugs they give the nursing person.
6 Some of the problems have already come up 7 today. One is that including the breast-fed infant or 8 child in this patient release rule doesn't get at the best 9 time to take these considerations into account.
10 Before you administer the material, finding out l
l 11 that the patient is nursing so that you can decide whether 12 you need to test now, whether you could use iodine 123, i
l 13 instead of 131, or if you have some options, that's the l
l 14 best time to consider it. So that's one problem with it in l
! 15 this rule.
16 Difficulty in calculating doses. There again 17 I'll get to what some of the solutions are, but that's a 18 developing state of the art for both occupational, where we 19 have already imposed the embryo / fetus dose. And the 20 methods of complying with that are evolving. So the 21 nursing infant is another issue and could limit the 22 decisions, as Dr. Siegel has said.
23 And there is the potential depending on how all 24 of this plays out that you might get into the diagnostic l
25 space and there theoretically might need to be confinement j NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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372 1 for additional patients.
2 (Slide) 3 MS. DRAGONETTE: Now, how to address the 4 problems that we just listed and we've been talking about, 5 what is the current thinking, at least in research, 6 although the staff is still talking and discussing? c Es hd 7 '
we"were; leaning toward protection of the nursing ginfantaj 8 So the strategy at this point would be not to 9 change the rule with respect to that. The proposed rule 10 did not have language saying " individual includes nursing 11 infant." We wouldn't add language that says it doesn't.
12 We philosophically have a very difficult time saying that.
13 So the rule would stay the same.
14 Then a discussion of the preventative measures 15 to ask, to plan so that you can do whatever mitigation you l 16 might want to do, put that in the guidance in the l
17 introductory part of the regulatory guide, but not make it 18 a requirement.
19 Focus on those. Focus and identify those 20 radionuclides that you've got to worry about. If you're 21 into diagnostic space, there's only a handful. The 22 guidance would list those and identify those. Then the 23 others, it would say for the others, you wouldn't have to.
24 So we could focus it on a select few.
25 And then provide a table of acceptable times to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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373 1 resume nursing. That concept's in several of the medical 2 recommendations. Sometimes it's six hours. Sometimes 4 t's 3 24. And we could come up with some tables on interruption 4 times for those where you would need it in a diagnostic 5 arena.
6 And then again address the problem of 7 compliance with instructions and say that the instructions 8 you give, you can assume that that's what's going to happen 9 and that that's acceptable, to emphasize that again.
10 (Slide) 11 MS. DRAGONETTE: The end. That's our current 12 schedule commitment to the Commission in the summer.
13 Obviously with all of these tables and these calculations 14 and with many of these decisions still being debated, 15 that's --
16 CHAIRMAN SIEGEL: I guess I'm still a little 17 bit confused about what you plan to do with the space 18 between 100 and 500 millirems, what you think you'd like to 19 do.
20 MS. DRAGONETTE: Requiring ALARA, instructions 21 to address ALARA, and leave it to the physician to 22 determine whether the multiple administrations will get you 23 above the 500 per year space but not have any recordkeeping 24 or --
25 CHAIRMAN SIEGEL: So if we look at proposed NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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374 1 35.75 -- do you have a copy there? Most of you should have 2 this. I don't know if it was distributed. It's actually 3 not in the book.
4 So if I understand what you're saying, 35.75, 5 proposed 35.75(a) would stay the same.
6 MS. DRAGONETTE: Yes.
7 CHAIRMAN SIEGEL: It would read "A licensee may 8 authorize release _from licensee control any 9 patient-administered radiopharmaceuticals or permanent 10 implants containing the radioactive material. The total 11 effective dose equivalent to an individual from exposure to 12 the released patient is not likely to exceed five 13 milliseverts in any one year." That would stay the same?
14 That's correct?
15 MS. DRAGONETTE: Right.
. c.,n wnwn 16 m._y. m..>.C_HAIRMAN1SIEGELif would Nowr*whaty happen w 0 to r*gtT:'*Z 2 am -
P 17 (b (b) should disappear.
/
18
{5 MS. DRAGONETTE: Depending on what we decide !f Yb 19 abcrut the written instructions and depending on whether we U $
20 dedideyouneedtomaintainarecordforthecasebycaseN{
g y-p (6 21 caldulations. I don't think we've worked out the exact kj
\ i! Q1 22 lanhage,butthosearethetwooptionsthatarestillon N M 23 theftable that.m.might_still.be in (b). #
y
, ~
x ,; . cwapmygmy, __,
24 MR. CAMPER: What do you mean by " case by case 25 calculations" in view of the 100-millirem threshold? What NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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375 1 are you referring to by " case by case calculations"?
2 MS. DRAGONETTE: Case by case calculations to 3 demonstrate compliance with the 500 per year would be the 4 new construct. If you're not using the cookbook tables 5 that are provided in the guides and you're using your own 6 assumptions on metabolism, excretion, all of those things, 7 if you're doing your own calculations --
8 MR. CAMPER: I was asking the question in the 9 context of (b) (1) or (b) (2) , which is what Barry was 10 getting at.
11 MS. DRAGONETTE: Maintaining that record, (2) 12 would go unless we wanted to put some provision tied back 13 to the 500 for keeping records on the case by case 14 calculations so people may be releasing patients with 400 15 millicuries in them, for example. And we'd like to take a 16 look at what the basis for that was. l 1
I 17 MR. CAMPER: I understand. i I
18 MS. DRAGONETTE: Is that your understanding?
1 19 Bill, do you want to say anything on that?
R 20 xCHAIRMAN'SIEGELt- 4What's wrohg:withithejconcept k ' ,1
.g 21 of. tieing 35.75.to= written directives'and addressing - < cA f u>
t h 22 pregnancy and breast-feeding separatelylforethings;that,
-a fl s tL z
23 don't;dealtwith written directives?
24 MS. DRAGONETTE: I don't know if we've thought 25 about how to word it connected to the written directive.
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t 376 1 We're still trying to decide the course of action. And i
l 2 then where to put the language will come later. So I don't 3 know that we've thought about the exact language that would 4 tie it to the written direction.
l 5 As far as not addressing the breast-feeding l
6 infant in this rule,.the problem we have is that now that 7 we have said in the proposed rule, now that the issue is on 8 the table that you should evaluate the exposures to the 9 breast-fed infant and they should meet this dose limit that l 10' we have justified exceeding the normal public dose limit 11 and going up to the acceptable upper bound of 500Ngggggggg 12 n4ith 13 protection 4= d4ffic"le--
fo thy,infane;mb as;w mm=w- And deferring to L m m m m na mr l
l 14 another rule, the embryo / fetus rule, that may or may not l
15 come about is aleo difficult for us from a philosophical 16 point of view, radiation protection point of view, because 17 we don't know when that rule may go and what it may say and 18 what the requirements are.
19 And we're concerned now with the disparity, 20 what we see would be disparate treatment.
21 MR. CAMPER: Kitty, I understand the reason 22 that you just expressed in terms of not doing it in another 23 rule, although, arguably, one could defend why we didn't 24 deal with it in this rule, clarifying that we would deal 25 with it under a separate rulemaking, because many of the NEAL R. GROSS j COURT REPORTERS AND TRANSCRIBERS j O23 RHODE ISLAND AVENUE. N W- i (202) 234-4433 WASHINGTON, O C. 20005 (202) 2344433 l
I
377 1 issues associated with the nursing infant are very 2 complicated and I think rise to a level of specific 3 consideration through the public comment scenario.
i 4 Now, having said that, though, what I'm 5 probably most troubled about is that the proposed rule, as 6 you have indicated, really didn't talk about the nursing 7 infant within this scenario. And then the question arises, ,
8 well, if we proceed and publish the rule and that becomes i 9 incorporated without a republishing and consideration of !
10 public comment on the issue, I'm concerned that we might be 11 subjected to criticism for that.
12 MS. DRAGONETTE: Well, I beg to differ that we 13 didn't raise it. It was explicitly. And I'll read the l 14 paragraph in the proposed rule preamble, "In most cases the 15 dose received by an individual exposed to the patient will j 16 be from external exposure. However, in the case of a 17 breast-feeding mother, the infant could be exposed 18 following ingestion of breast milk. In this case the 19 five-millisevert limit applies to the infant as the 20 individual likely to receive the highest exposure."
21 And then the companion draft regulatory guide 22 -- you know, explicitly I could read the words -- also 23 elaborated on it even more fully that they would be 24 considered and outlined some of the options they could 25 have.
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378 1 For example, if they're going to be 2 administered it said the cookbook tables don't apply to 3 persons who are breast-feeding because of the infant j 4 problem. And then it said if they are breast-feeding, 5 there are alternatives available, " Licensee may determine 6 that the quantity and type administered would not likely 7 result in more than the five milliseverts."
8 A second alternative would be to stop for some 9 period of time or to postpone the administration if it were 10 medically acceptable.
11 So it was aired in both the proposed rule and 12 the regulatory guide. So we have a sufficient legal basis 13 to include this and to do this while we consider the other 14 separate rulemaking.
15 Now, when the other rulemaking is developed and 16 on the street and we're trying to work how to reconcile the 17 two, then I would think then we might be in a position to 18 do some adjustments. But to defer totally to that 19 uncertainty of maybe someday --
20 MR. CAMPER: Well, then your comment earlier 21 that this wasn't addressed was strictly related to the 22 100-millirem issue, then? I get the impression from the l l
23 comments you made a few minutes ago that this had not been l 24 addressed as clearly as it might have been in the proposed l 25 rule.
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379
^
1 Now, I guess from what you just read, I assume 2 you're referring to the 100-millirem issue, then, that you 3 just alluded to? Everything you said was about the 500.
4 So I guess your comment, then, was about --
5 MS. DRAGONETTE: The table had both numbers.
l 6 Complying with the 500, do you consider the infant in 1
7 meeting that limit?
8 MR. CAMPER: The 500?
9 MS. DRAGONETTE: The 500.
10 MR. CAMPER: Yes.
11 MS. DRAGO%2TTE: Yes. Maybe we didn't focus on 12 it as much as you would have liked.
13 MR. CAMPER: I think the fundamental --
14 MS. DRAGONETTE: But it was out there on the 15 table.
16 MR. CAMPER: Well, I think the fundamental 17 question becomes one of: What happens in 100 millirem and 18 between 100 millirem and 500 millirem? The idea is that 19 range captures nursing infants, which is the point that you 20 made at the outset.
21 I guess in the final analysis, what we end up 22 doing between 100 and 500 gets at my concern of whether or 23 not we have made it as clear as we might have to the public 24 in terms of the implications for nursing infants in that 25 range.
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l
7__
380 1
Now, it's a function of what we end up doing at
._ 2 100 and above.
l 3 MS. DRAGONETTE: Which at this point we're 4 considering doing very little instructions.
5 CHAIRMAN SIEGEL: And dropping (b) (2) ? 1 6 MS. DRAGONETTE: Yes.
1
( 7 CHAIRMAN SIEGEL: That works effectively. I l
8 think that's correct. Dennis, are you with that? Do you 9 have a copy of the rule in front of you? !
l 10 MR. SWANSON: Yes.
11 CHAIRMAN SIEGEL: So if I'm reading you 12 correctly, '.t says you can release people if the dose to a 13 member of the public is not likely to exceed 500 millirems 14 and than if the total dose will exceed 100 millirems, you 15 provide instructions. Including written instructions is 16 the language I would suggest you include.
17 MS. DRAGONETTE: I think that's a --
18 CHAIRMAN SIEGEL: Tell them how you kept the 19 dose ALARA and drop the recordkeeping, drop the Paragraph 20 (2).
21 MS. DRAGONETTE: Right. JIhe@;1eI44te2M 2
9 E "l* % Lh*d **; ** M L oil 2 :!21*2 ki W M 23 conces1ar;a"*TdocnamenthsTp6sFro neerasyrcaser"diiMiliffBns a 24 when:Mussirmie=*hemuy _ _
25 MR. SWANSON: If you release them other than by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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381 1 a table?
2 MS. DRAGONETTE: Yes.
3 MR. SWANSON: Okay. But then we still have the 4 breast-feeding issue; right?
5 CHAIRMAN SIEGEL: Well, the actual sum 6 recordkeeping if you go outside of tabular limits was 7 actually implicit anyway because you can't comply with the 8 rule. Even if you dropped that second paragraph, you can't 9 comply with the rule without knowing that the dose will be 10 less than 500 millirems.
11 How can you know that the doEe is less than 500 12 millirems? You'd know it by common knowledge. And common 13 knowladge is I went to a table and the table says if I do 14 this, I achieve the intended effect or you do a 15 ea1cu1ation. tg#tFE2m1NI""*? -2W 16 DM 17 *"%CNobir73rguess MMiil?issi3iEJisIZAre;yons;hM1tgQ 18 1 eggpM16rieenWTe7o fifen2aipapenE~nInfidTM~
19 YtMBBINMBWWRee t probabJne;mAessDEMildTeciisthisse ,I
\ 20 :1awthattifwit3stnot+donefin yaccordance wiEh~7fWyiMiInsouM t
\ u%uy -
21 ggtonhave Nf M I . U i 22 That's complicated because I know you don't 23 like to tie anything in the rule to the regulatory guide 24 because the regulatory guide doesn't have the legal status 25 and is subject to change.
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I
- l l i 382 l
1 MS. DRAGONETTE: Right. So that's something we 2 have to think about, how to do that.
3 CHAIRMAN SIEGEL: Yes. I know. We certainly 4 don't want to put the tables in Part 35.
5 MS. DRAGONETTE: No. It would have to be 6 through a rulemaking.
l l 7 CHAIRMAN SIEGEL: That would make it pretty 8 ponderous.
9 MS. DRAGONETTE:A Doing;theEtablesEfdr2thefi I
10 gursingy.infantsswill'::give you r the n cookboo.k; direct;way;of l l
11 dealing +withTthatI"fssGE5 That would be our intent, i 12 assumin erm mr_g we go ahead down that path, that they would --
h j
13 ; CHAIRMAN SIEGEL: I would just encourage you, i l
\ I 1 14
^
IthinkIsaidthisinOctoberaswell--encourageyouf 15 as you work more on the regulatory guide that you also 16 }considerputtinginsomeguidancethat is not generally b},(o 17 Iknown in much of the community. And that is that you also[
O b >:
18 onsider in the case of I 131 when breast-feeding should b 19 8
stopped before the I 131 administration because it isn't an
! r 20 jour before you give the I 131. [ [p.
i 21 It probably should be two to three weeks before, f
22 it because the dose to the breast starts to become a 4rg 23 significant concern, especially with the large doses of 24 I 131. And, I mean, we may as well educate the community 25 while we're at it. _,._.-y -~~,m,...m.,
,. ~,,
. ==m ~ vmv. ~;~,,:. w =- ~~~w
" " ^
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i .
l 1 383
- \
1 MS. DRAGONETTE: In that guidance, dealing with 2 the preventative mentioned that as well. i 3 MR. SWANSON: This whole breast-feeding issue, I
4 the major concern, it seems to me, is that making sure that l 5 the mother, who is also the patient here, is adequately 1
6 informed of the risk to the breast-feeding infant and 7 adequately informed that she will have to or should 8 discontinue breast-feeding and for what period of time 9 because, in reality, it's going to be the mother. I mean, 10 the infant can't consent to this procedure himself or 11 herself. So the mother is making the determination of l 12 benefit and risk for the infant, basically. Okay?
13 And so does the issue come down, the true 14 concern come down to making sure that women in general that 15 are treated with iodine 131 are informed of the risk to a 16 breast-feeding infant and what might go along with that?
17 MEMBER NELP: Did you ever put yourself in the l
18 position to say -- this is asking about rules and 19 regulations -- "If you receive I 131, mother should not !
20 breast-feed," period, and not make it an issue of exposure, 21 make it a point of fact? Did you ever get to that point?
l l
22 DR. GLENN: We do, in fact, have a rulemaking 23 under development for a proposed rule that would talk about 24 how to avoid unintended exposure, certainly, of the 25 embryo / fetus. And also, I think, the Commission originally NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON. D C. 20005 (202) 234-4433
384 l l
1 directed us to consider the breast-feeding infant. So it l 2 would be probably a rule directed at unintended exposures.
~.
3 MEMBER NELP: The real life world is if I have 4 a woman who is breast-feeding and I'm going to treat her 5 for thyroid cancer, which is really the only situation I i 6 think that we're talking about --
7 CHAIRMAN SIEGEL: No. Hyperthyroidism also, 8 Buzz, and, frankly --
9 MEMBER NELP: Or hyperthyroidism. I'm sorry.
10 CHAIRMAN SIEGEL: -- a diagnostic uptake dose 11 of I 131 you shouldn't breast-feed.
12 MEMBER NELP: But if you do those things, we 13 usually say "We're going to do this procedure, and you 14 really should discontinue. You have to discontinue 15 breast-feeding or we won't do it under this," period.
16 That's the real world. l l
17 Yes, there are some diagnostic considerations.
18 And we always say "If you're going to have this test, you 19 stop breast-feeding for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />" or whatever the i' 20 requirement is. I 21 But if it 's a ;L gh-dose therapy, which is 22 largely what we're talking about, in the real world you say 23 "You have to plan to stop breast-feeding before we do this.
24 It's going to interfere with your treatment, lest we can't 25 treat you."
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385 1 MEMBER BROWN: Is it enough of a medical hazard 2 that you would consider prescribing -- is it perganol?
3 What's the drug? I know it's under --
4 MEMBER NELP: Ordinarily for some if they're 5 permanently going to stop, it will stop themselves in 6 plenty of time. And you don't treat these people 7 overnight. You have a --
8 MEMBER BROWN: Well, if what Barry is saying is 9 that you want to stop breast-feeding not only for the 10 infant but because the dose to the breast, you have to 11 permanently stop because it's not like you.can stop and 12 start and stop and start --
{
13 CHAIRMAN SIEGEL: The bottom line --
14 MEMBER BROWN: -- if you're expressing milk, 15 you're still going to be --
I 16 CHAIRMAN SIEGEL: -- is if you're going to give !
17 I 131 iodide to a patient, even a five-microcurie dose for i
18 a thyroid uptake, the patient has to stop breast-feeding, !
19 period. l 20 MEMBER BROWN: Forever.
21 CHAIRMAN SIEGEL: #Now3foEEfive-micrgqurp 22 desePI2wouldnttgstopetwotweeks .insadvancerbecauserthe
~ , . ~w ~ ~ -
- ~ -:nuxdose 23 to!therbreast*would bes trivialjjalthoughithendoppAg2the )
24 , irgf anc t a r thyroid :would r be;. higher;than::hwould;beahappy !
25 .nwit,h. ,4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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.. I 386 1.
ForI6:fiv;).gi-llicurieydose foghyperthyr.oidi,sm n l 2
therapy,vL,tell
. _. m -
patients to stop, breast
._4 .m 4 ms. ~
.mmma, feeding wtwo
. weeks
--~
3 greithEtylcome;fi[rM[rlittf!ttd5E6 . And for thyroid 4 carcinoma, same thing. I l
5 MEMBER BROWN: And never resume?
6 \
CHAIRMAN SIEGEL: And never ever ever ever !
7 resume in that infant.
8 MEMBER BROWN: Because I think it's very 9
misleading when you read all of this stuff about expressing ;
10 the milk. And it seems like a kind of a temporary --
11 !
CHAIRMAN SIEGEL: No. That's with a bone scan 12 or pertechnetate.
I 13 MEMBER NELP: Twenty-four hours.
i l
14 MEMBER BROWN: Okay. So we're not talking 15 about the temporary discontinuation?
i
-16 CHAIRMAN SIEGEL: There are a ft.w 17 radiopharmaceuticals for which permanent cessation of 18 breast-feeding is the medical recommendation. I 131 is one 19 of them. Most people think gallium imaging is another one.
20 MEMBER BROWN: And how does the medical 21 community handle that, do you think? I mean good doctors i 22 and bad. I 23 MEMBER NELP: Probably very much like we !
24 discussed. I don't think, number one, it's too --
25 MEMBER BROWN: Does NRC have any indication NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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387 1 that that isn't happening, that they're worried about that?
2 CHAIRMAN SIEGEL: One event; correct? Two 3 events. Okay.
4 MEMBER NELP: It's only done by people who have 5 particular experience in this area, and it's a very 6 infrequent occurrence. It's taken very seriously.
7 MR. SWANSON: How we address, actually, all of 8
these issues at our institution is we have an informed 9 consent form where basically we require the patient's 10 informed consent to participate in the procedure, which the 11 informed consent form addresses the issues of pregnancy, 12 addresses the issue of breast-feeding. It addresses the 13 instructions to the patient post the procedure. It also 14 addresses that the patient has read the consent form and 15 understands what they've read and any questions they have 16 --
17 MEMBER BROWN: So it says "I am not pregnant.
18 I am not breast-feeding. And if I am, I will stop and not 19 resume"?
20 MR. SWANSON: Correct.
21 MEMBER FLYNN: My question is -- help me with 22 this -- how many of the patients -- you said 60,000 23 procedures a year. How many procedures are done with i
24 iodine 131 would be done in the woman in breast-feeding?
25 CHAIRMAN SIEGEL: A small number. !
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388 1 MEMBER NELP: Very.
2 MEMBER FLYNN: One-tenth of one percent?
3 CHAIRMAN SIEGEL: With both therapy of 4 hyperthyroidism and imaging of thyroid carcinoma and 5 treatment of thyroid carcinoma, I probably encounter --
6 it's a total patient group of 250 or so patients a year I 7 think was the number. Stewart, is that the total, 250-300 8 patients in that list I gave you that I lost?
9 One or two a year that this comes up. So it 10 occurs infrequently, but when it occurs, it's something I 11 take very seriously.
12 MEMBER FLYNN: Nationwide, though, it's 13 probably a few hundred a year?
14 MEMBER NELP: Oh, yes.
15 MEMBER FLYNN: Five hundred a year?
16 CHAIRMAN SIEGEL: Probably not much higher than l 17 that, but it's, nonetheless, important.
18 MEMBER FLYNN: Oh, yes.
19 MEMBER NELP: But it happens and --
20 MR. SWANSON: My guess would be that strontium 21 89 might also be a problem, although I've not seen any data 22 on what's excreted in breast milk. But since it is a 23 calcium analog --
24 CHAIRMAN SIEGEL: Very, very few patients with 25 metastatic breast cancer being treated with strontium 89 NEAL R. GiFU3SS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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389 1- are also breast-feeding.
And no patients with prostate 2 cancer are breast-feeding. I think we can say that as an 3 absolute fact. There are few absolutes, but that's one of 4 them. If they are, we have to talk about that in a 5 different kind of vein.
- 6. Bill, did you have a comment?
7 DR. MORRIS: I just wanted to focus again on 8
the issue of the written directive and the fact that there 9
are certain administrations, as I understand it, that would 10 not be covered by a written directive that would have a 11 potential for causing rather large doses -- well, I don't 12 want to use that word -- doses up in the 500 and above 13 range for a nursing infant.
14 And so the game plan that we have in mind right 15 now is to pick out and specify in the regulatory guide 16 those isotopes which we are saying if you provide 17 instructions for those isotopes to a potentially nursing 18 mother, that that will be a sufficient way to deal with 19 meeting the criterion of likely to exceed 500 millirem.
20 And then included with that would be the dosage and dose 21 relationship that we believe is involved in the specific 22 set of isotopes.
23 Understand it's a fairly limited number, t g 24 this~ wouldebea.axshort. list thatis4oversan&aboyhtJim 25 written;difsEE M E $EngbryRhatYwouldnit?otherwise: require NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON, D C, 20005 (202) 234 4433 j
390 1
.amwrittea,JiiRpRtige.or anything:else;beJone; 2
And then for that set, there would be some kind 3
of an information about when that nursing could resume.
4 And I gather you're saying that for certain isotopes, the 5
words there would be never. But the iodine 131 is probably 6
not -- well, I guess it would be in that list, too.
7 CHAIRMAN SIEGEL: It's critically on that list.
8 DR. MORRIS: Okay. So I want to make sure that 9
it was understood what our idea is right now so that if you 10 have any comments on that particular strategy, we could 11 gather those now.
12 CHAIRMAN SIEGEL: Yes. I do have one comment, 13 and that is as you sit down to start working on that table, 14 that you let one or more of us try to help you with it, 15 either as a formally convened subcommittee to come in and 16 do a working session with you or at least run it by us so 17 that we can react to it and tell you whether we think 18 you're on the right track and whether your science --
19 because this breast-feeding stuff, as I know you all know 20 from having looked at the literature, is not easy to 21 unravel. It's very complicated. It does involve a 22 moderate number of assumptions because the database is 23 fairly limited.
24 There's a relatively small number of patients 25 in which measurements c f breast milk activity have been NEAi. R. GROSS COURT Rt.MP TERS AND TRANSCRIBERS 1323 RHOOfi ISLAND AVENUE, N W.
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5 .
391 1 often enough to come up with decent dose recommendations.
2 And then there are other issues about how much the infant 3
absorbs across the gastrointestinal tract, and it goes on 4 and on in terms of the complexity.
5 As it turns out, most of the other 6 radiopharmaceuticals for which breast-feeding should either 7
be stopped for a very long period of time or permanently 8 ceased are not in your regulatory space. It's gallium, 9 thallium, some Indian radiopharmaceuticals that are 10 non-byproduct. And the vast majority of the other 11 technician things turn out to be things that with rare 12 exception you can handle with a maximum of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of 13 cessation of breast-feeding.
14 And for some technician radiopharmaceuticals, 15 there's no need to stop at all, like technetium DTPA. The 16 average dose for renal imaging, the standard literature 17 recommendation is not to worry if the dose is too small to 18 fret about.
19 MR. SWANSON: Where it gets complicated is it's 20 not isotope-dependent. It's radiopharmaceutical-dependent.
21 CHAIRMAN SIEGEL: Right. Good. Any other 22 comments? Judy? Buzz?
23 MEMBER NELP: David, does the FDA label, 24 package insert label, say you should not breast-feed or 25 does it say this is excreted in breast milk?
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392
+
1 DR. WOODBURY: In most of the regulations I've 2 seen, they've put limits on it, a person should not 3
breast-feed for a certain time limit after administration 4 of the dose. I've not seen a regulation where it says 5 "should not breast-feed ever." Usually, say, with
)
6 technetium, it's 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> or something of that nature with d I
7 that and weeks, months out.
'~~ A-8
~'~
CHAIRMAN SI
- ?'NMQ5KlihMEtCNW""WMYsN#"E" GEL :
Does the dommittee generally, i
9 : agree that the space between 100 millirems and 500 i M t 3 ep 10 : millirems should be handled the way we've discussed it, i
f i
5 11 ' basically that it's an area in which instruction should bet \ l i
12 providedbutthattherecordkeepingrequirementshouldbe} ;
13
- iessentiallyeliminatedoronlyrequiredwhenextraordinary$, y
}
14 calculations are used to justify the release? g thereg./
r, ,
l "* *m,n o e f
a M
15 general-consensus "on';that? y ; u;an:xcusa w 8 13.xg,gm.whr:Ob% Y kMhD4T are
)
And those instructionskd[
16 (j MEMBER BROWN:
- 17 written and verbal, clearly? %
18 CHAIRMAN SIEGEL: Correct, yes.
19 MEMBER NELP: Do you have a problem saying you 20 should give written instructions without saying what those 21 instructions should include? I could give a set of 22 terrible written instructions or I could give a very good 23 set of written instructions. Do you require written 24 instructions in any other regulations?
25 It's sort of a new concept to me, but if I were NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAMD AVENUE N W.
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393 1 going to say " Joe, I want you to give this person written 2 instructions. And here's what I want those instructions to 3 include" or do I leave it up to the wisdom of the person 4 preparing the written instructions?
5 MS. DRAGONETTE: The way the rule is 6 formulated, even the proposed rule was formulated, it left 7 the exact content of the instructions up to the physician 8 to be tailored to the procedure and the patient.
9 And guidance was in the draft regulatory guide 10 on topics that should be addressed and why you're 11 addressing them. And the Society of Nuclear Medicine 12 brochure for iodine therapy was mentioned as one that hit 13 the right points.
14 CHAIRMAN SIEGEL: I think in general it would 15 be better to defer --
1 16 MS. DRAGONETTE: So the scheme would still be 17 in guidance -- )
18 CHAIRMAN SIEGEL: -- to defer to the regulatory 19 guide that gives examples of what sorts of instructions you 20 might provide and then acknowledges that there are already 21 things out there that you can tap into as ready-made.
22 I mean, the SNM pamphlet has been out for 20 23 years. And you can use that as your instructions. And 24 there are places where you can fill in the blanks about how l 25 many hours or days you should avoid Activity A, B, C, or D NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON, O C 20005 (202) 234-4433 l
394
. 1 that are tailored to that specific patient and their 2 lifestyle and the way they are. '
3 I don't think we'd want to have the detailed !
4 specific instructions built into Part 35 because they'd end 5 up not being right. And, in fact, then that would start 6
really interfering with medical judgment about what's right 7 for that patient.
I 8 MEMBER NELP: I was just questioning. Is this 9
a new concept to require written instructions to a patient?
10 CHAIRMAN SIEGEL: Not at all.
11 MEMBER NELP: That's something that --
12 DR. GLENN: It currently exists in the 13 regulations.
If you hospitalized and you're going to 1 14 release them, you do have to already provide instructions 15 to keep the household --
I 1
16 MEML2R NELP: Written. No.
1 Written 17 instructions.
18 DR. GLENN: Oh, written instructions? No.
1 19 MS. DRAGONETTE: You're talking about 35.315 l 20 and 415 and --
21 MEMBER NELP: See, I think it's an interesting 22 area. If you require written instructions, that's okay, 23 but that doesn't mean it's going to be any good.
24 CHAIRMAN SIEGEL: But neither would the 25 instructions non-written necessarily be any good.
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. 1 MEMBER NELP: Exactly. That's the whole point.
2 Requiring them to write them doesn't mean that you're 3 providing a quality set of instructions.
4 MEMBER BROWN: Yes, but if you have a bad 5
doctor that's giving you bad instructions anyway, I mean, 6 you can't like police the quality, it seems. ,
7 CHAIRMAN SIEGEL: I mean, let's say the NRC 8
generates a set of instructions that I am them required to 9
hand out to the patient and I give it to the patient and 10 say "The NRC made me give you these. I don't agree with 11 anything in here.
12 MEMBER NELP: Well, I say "The NRC makes me put 13 you in the hospital for this treatment. I think I could 14 take care of you at home with less cost."
15 CHAIRMAN SIEGEL: Well, you may be able to 16 under this rule.
17 MEMBER NELP: Yes. There may be --
18 CHAIRMAN SIEGEL: I think the content of 19 written instructions is something that should be left to 20 individual physician judgment guided by the activities of 21 professional societies with the NRC tapping into that 22 information for its regulatory guides.
23 And there is good data out there about what to 24 tell patietts. It's in ICRP documents, NCRP documents, and 25 it's in SNM orochures that you can buy for 10 cents each NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON. D C. 20005 (202) 2344433 J
396 1 and give to a patient, whatever they cost. They're not
.- 2 very expensive. C g, pp- --- ~-
3 j gjM. 55"Ehs#Wap'"I*hsard'this overwhelminge conshiGHik y -
4 e we* generated &is that welre basically 2recom$sEdliift}iaGy6b
/*5 s
_3r_op*tiroposedv35.. 75 (b) (2)aoreworksityintotsomething;thatg }
Y t 6 g
tied,to -amanan an extraordinary wm , s ~ . circumstance.
un- .. . -Butrotherwiserwefre
~
'- f
.saying n_weas we :- canavork1withw that
- ,. rule w a athe w Awayrityis w a s 2 M GP - I 8 Okay. Thanks, Kitty.
9 We're a little bit ahead of schedule, but it's 10 probably right to take a break.
So let's take a 15-minute 11 break.
12 (Whereupon, the foregoing matter went off the 13 record at 9:49 a.m. and went back on the record 14 at 10:07 a.m.)
15 CHAIRMAN SIEGEL: Moving right along, Judy, I'm 16 going to tell you how nuclear medicine practice would be 17 disrupted by this rule because I remembered.
18 MEMBER BROWN: You have to tell me how it is 19 going to be completely disrupted.
20 CHAIRMAN SIEGEL: Well, could it be just 21 partially disruptive?
22 No.
MEMBER BROWN: You said completely.
23 That's why I asked: Wasn't it an overstatement?
24 CHAIRMAN SIEGEL: Okay. Let me explain it.
25 Follow my logic. Let me see if I can walk you through NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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397 e l' this. If'the rule requires that -- not everybody is here.
2 Probably can't start yet.
3 MEMBER BROWN: You know what? I'm okay with 4 this if you don't want to get into it.
5 CHAIRMAN SIEGEL: No. I do because it's 6 actually not for you that I'm doing this. It's for the NRC 7 that we need to work this through because this was 8 something that came up three weeks ago. And because I'm 9 getting old, I didn't remember. I'm not ready to admit 10 what Ronald Reagan admitted yet, but I lost it.
L __,c--- _._.
11 "
nues e m __ If the rule says thaTpoir
\
1 can't authorize from release people who have -- if someone i i 136 is likely to be exposed to more than 500 millirems but also 14 says that you have to provide written instructions if tA 15 anyone will get more than 100 millirems and if that i 16 component is not specifically tied to written directives, h 17 then in order for a licensee to prove that they're 18 complying with the rule, they will have to have some ,
19 t verification that every woman who was of breast-feeding 20 potential was evaluated and got the written instructions if I 21; there was a chance that they were breast-feeding. g 22 So in a sense to prove compliance, it almost F 23 meant that every woman would end up having to probably sign 24 a statement that says "I'm not breast-feeding."
25" '
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398
. 1 involved in_ keeping them in the hospital. I mean, that
! 2 doesn't sound --
3 CHAIRMAN SIEGEL: You wouldn't have to keep 4 them in the hospital. I'm talking about people who are 5 having bone scans now.
6 MEMBER BROWN: Okay.
j 7 CHAIRMAN SIEGEL: See rethe*proydfit"iW"ri't] tit""h6w 8 if s_-%come= F~ -a-bone scanNe~t~'s say~~a~Ehyre'idTein
, .nn .
- i l 9 wi t hited!!Mii!I!fu,m_pe rt e chn e t a t e , that goes to tlie~EnWEE"TFom >
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10
..g=a-mememnmemn n a,ma.m thatsthat*Msht
+%
end up being 150 millirems. _It'_s Edl,ow 11, , 45 0 0 . = **eeDA' 12 Well, we wouldn't have to keep them in the 13 hospital. We wouldn't have to force them to Otop 14 breast-feeding. But we might have to give them written 15 instructions in order to validate that we've ca.ight every i
16 woman who needed those written instructions. We'd probably l 17 have to ask every woman who could potentially be i
18 breast-feeding and may need to document it. And so that's 19 where --
i 20 MEMBER BROWN: That doesn't sound like such 21 big deal to me.
22 CHAIRMAN SIEGEL:
>(N Y. k(l It's a big deal. It's Dg 23 keeping track of another 10,000 -- okay. I do in my place 24 12,000 patients a year. Half of them are women. Let's say i 25 half again of those are of breast-feeding potential.
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399 o 1 That's another 3,000 records I have to hold onto. That's a 2
big deal to find the four who might be breast-feeding whom 3
I probably would have found anyway.
4 MEMBER BROWN: But you being a diligent person 5
are going to go through the process to find them anyhow.
6 CHAIRMAN SIEGEL: No. I go through the process 7
by having brochures in my waiting room, having signs that 8
say "If you're breast-feeding, do this," have my 9
technologist ask, but I don't keep a record of it J 5_1 10 that's,the part that is of concern. MEW 91tfdineMI.1 tfi"d'd 69sF9FFisGEntidesitEkeepIazaosord;syg 11 12 There are a lot of things I do in the day to 13 day practice that I get a piece of information, I act on 14 it, and I don't make a record of it. Not every single 15 thing we do gets written down and kept in inspectable form.
16 So that's the problem.
17 MEMBER BROWN: What about what Dennis was 18 saying about the informed consent? I mean, that --
19 CHAIRMAN SIEGEL: Informed consent is for 20 therapy or for five-millicurie doses of I 131. We don't 21 get informed consent for bone scans.
22 MR. SWANSON: In other words, we're tieing the 23 informed consent back to those agents for which we have a 24 written directive.
25 CHAIRMAN SIEGEL: Written directive. So that, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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-, 1 in part, was my rationale three weeks ago for suggesting 2 that' fretting about this in relation to the written 3 directive made sense;3qrns ,,addre_ssing_ breast-feedin a
a us 4
generically
, _by_an A lerDatiyA e rula. mad Legns_e..
5 And so I guess if anyone from Research is still 6
here and wants to -- do you all want to say what you think 7 about that potential problem?
8 MR. McGUIRE: The problem you're concerned 9
about is recordkeeping for breast or potentially child --
10 . CHAIRMAN SIEGEL: Well, how you would expect 11 that someone could demonstrate compliance in the space 12 between 100 and 500 millirems with respect to whether or 13 not written instructions were provided to a potential g 14 breast-fed infant. g kb 15 MR. MEGUIREi MI.?can't2.seeranyclikeli M N te 16g. -t_he ~re,gulation ,would . specify .. records .forg-- that .
-m m . . a m a n,_ g a w .a n I think it 17 would be basically you saying to an inspector that that's 18 your policy and perhaps having some sort of for the written 19 instructions a typical set of instructions that you would 20 give out in a particular situation where it's appropriate.
21_ .But.nthatistnotgeomething;thatchastbeen;developedica: tafft 22 'consensusyour MW 9 OnOSS
- 23 CHAIRMAN SIEGEL: Okay, I guess.
24 MR. CAMPER: Well, Dr. Glenn and I were just 25 conferring on this very quickly. I mean, if you really NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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.. 1 look at it, this ends up being an inspection phenomenon.
2 l And it would appear that either it's something that would 3
not be-inspected or there would be a record, which could be 4 inspected. And that's an. inspection guidance call.
5 DR. GLENN:
I It could be inspected in general 6 that there is a policy in checking and people have been
.7 instructed in that policy,70tMf*thweSagasch 8 -
-recordkeeping-requirement,you woulgnot;betableft oj veri,fy
~~
9 ehre-by-eased t
'10 CHAIRMAN SIEGEL: But in a way, the direction 11 where we were headed with the pregnancy and breast-feeding l
- 12 rule in the past actually was much more explicit. And it l
13 actually provided more assurance that the job was being 14 done properly than this rule does.
15 This rule sort of seems to leave kind of a wide 16 open gap where even though people might be doing a very
- 17 good job, it's less clear-from the language here that the
-18 licensee would have to be as proactive in terms of trying 19 to capture those breast-feeding mothers and making sure 20 they get the instructions than the kind of direction we 21 were heading in where there might be requirements for 22 having signs and having brochures or giving a pamphlet to a j 23 woman of breast-feeding potential.
24 Comment? John? Steve? Kitty?
-l 25 MS. DRAGONETTE: As I understand your concern NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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402 o 1 with the diagnostics and if you couple that with the 2
approach, as Morris summarized it before the break, where 3
we would identify just certain radiopharmaceuticals, only 4
certain chemical / physical forms of certain nuclides where 5
this was an issue, that you would have that group of 6
procedures for which you would have to worry about this 7 issue. -I Cthb~ pot'entiai if^they-don't stop"nurbingri~s-that.
l
\
8 t
.the-infant-could-get-more than;100,. then they-would-have-to .
I 9 .give-the-instructions.
What does that mean and how do you I i
10 deal with that? )
{
11 I think that the comments on having a procedure 12 or if we list these, assuming we list these M f$g 13
-regulatory-guideFyou2d-say"For-these proceduresPwb"give*
14 the-brochure,_ We give the instruction," but based on our
)
15 informal discussion, too, you were pointing out that you-16
.wou 1&m e e d ~a~ col'dshi'iii" t ho s e' t abl e s - a t the__.10 D_and _a t the _
17 500.
18 It would need to trigger the potential for five 19
-- it would need to deal with the two dose limits in giving 20 the instructions. So those tables should include a 100 21 threshold for giving the instructions.
s v
22 CHAIRMAN SIEGEL: Yes. Well, it's another-23 pqtentialJ roblem that I just think needs to be thought 24 about in terms of the way you're going to address ensuring 25 compliance because if it involves having additional NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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403 g 1 documentation that it's been dealt with, it's more 2 difficult.
3 In that case --
4 MS. DRAGONETTE: John?
5 CHAIRMAN SIEGEL: John, do you have a comment?
6 MR. TELFORD: John Telford, Research.
7 Just let me see if I understand the scope of 8 this problem.. Let's say that there are approximately 2.2 9 million potential breast-feeding patients out of 10 10 million. I think we've done this calculation before.
11 That's approximately correct. l 12 But let's reduce that population by those 13 patients who are going to receive radiopharmaceuticals of 14 interest; in other words, the ones we want to watch out 15 for. So now we're down to a smaller subset. I don't know 16 the size of that, but it's pretty small.
17 Then you could reduce that by those patients 18 for which you're going to deviate; that is, not use the 19 cookbook tables in the reg guide. In other words, this 3
20 departure is for individual calculations. So now we're 21 down to a much smaller subset.
22 So maybe your question is: How do you prove 23 that for all of those patients you did the right thing?
24 And maybe you're asking: Are we expecting the licensee to 25 either document that for each of those patients, however NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W-(202) 234-4433 WASHINGTON. D C. 20005 (202) 234-4433 J
a 404 1
cmall, you really gave the instructions or are you asking 2 us if we're going to expect the licensee will show us the 3 typical set of written instructions that were issued to 4 tho'; ? kinds of patients? Is that the problem?
5 CHAIRMAN SIEGEL: That's part of the problem.
6 I mean, if the answer is we have a procedure in place that 7 says when we do a pertechnetate thyroid scan we ask the 8 patient if they're breast-feeding and if the answer is l 9 "Yes," we instruct them about cessation of breast-feeding, 10 if that does the job, then that's fine.
11 On the other hand, if the question is any time 12 we do a study on a woman between 15 and 50 years of age we 13 obtain a signature from them on a form that says "I assert 14 that I am not breast-feeding," that's where it gets -- the 15 latter would be a lot more complicated.
16 MR. TELFORD: I think not.
17 CHAIRMAN SIEGEL: Okay. All right. Let us l 18 move on. Janet, the ANPR for Part 35. That ought to be an 19 interesting job.
20 ADVANCE NOTICE OF PROPOSED RULEMAKING FOR PART 35 21 MS. SCHLUETER: My name is Janet Schlueter, and I
22 I'm a member of the Medical and Academic Section. I'm 23 going to take just a few minutes to describe to you the 24 staff effort to issue an advance notice of proposed 25 rulemaking for a major revision to Part 35. We commonly NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE tSLAND AVENUE, N W (202) 2344433 WASHINGTON. O C. 20005 (202) 2344433