ML20216D086

Incomplete Transcript of 950512 Meeting of Advisory Committee on Medical Uses of Isotopes in Rockville,Md. Pp 373-375 & 512-557.Supporting Documentation Included

ML20216D086
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Issue date:	05/12/1995
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References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-088, AE41-2-88, NUDOCS 9804150177
Download: ML20216D086 (64)

Text

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373 1]

pp{

UNITED STATES OF AMERICA.

o 2

NUCLEAR REGULATORY COMMISSION

$6M/->

2 3

+++++

4:

ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) sp

+++++

7i '

FRIDAY, MAY 12, 1995 8

+ + +++

9' ROCKVILLE, MARYLAND

'i

10. '

+ + +++

11 The Advisory Committee met at the Nuclear l1 12j, Regulatory Commission, Two White Flint North, 11565

i t

13!I'Rockville Pike, Room T2B3, at 8:22 a.m.,

Barry A.

Siegel, I

i 14; Chairman, presiding.

j 15l MEMBERS PRESENT:

h l

16l BARRY A.

SIEGEL, M.D., Chairman t

l '7 '

DANIEL F.

FLYNN,'M.D., Member 1 811 JOHN GRAHAM, Member l

19:

WIL B.

NELP, M.D.,

Member d

20!

ROBERT M. QUILLEN, Member il i

21n JUDITH ANNE STITT, M.D.,

Member 22, DENNIS SWANSCN, M.S.,

BCNP, Member i

il 23l LOUIS WAGNER, Ph.D, Member 0

24!!

25 1:

NEAL R. GROSS cocar APOA'EDS #4D TRANSCRIBEAS 9804150177 980402 PDR PR 1323 AMOCE ISLAND A.ENUE N A

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374 ACMUI STAFF PRESENT:

li I

2i Torre Taylor 3

4,, ALSO PRESENT:

5l Janet Schlueter 6lj Sally Merchant 7,:

Patricia Rathbun u

8lj John E. Glenn l

h 9l' Mark Rotman l

I I

t 10i Patricia Holahan

!i 11 Chairman Ivan Selin i

12 Commissioner Gail de Planque 13ll Myron Pollycove

!i 14 ' l Steve McGuire h

15l Stewart Schneider

!I 16;l Larry W.

Camper 17!

Josephine M. Piccone 18l!

19. ;

't 20I h

j 21-i 22;.

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l 23d l

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24h, t

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375 l

7 NDEX l

ll

!i l

2 AGENDA ITEM PAGE l

3 Discussion of Dose Ranges in Written Directives 376 l

4i Discussion of Revisions to Regulatory Guide 10.6

,16 l

ti I

5li Status Report on Implementation of the Quality t

l l

6l Management Plan Rule 479 l

7;l Update on the National Academy of Sciences Study 438 l

8,e, Summary of " Business Process Re-engineering" 496 9!' Update on Rulemaking 509 l

Administrative Matters 559 10!i!

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12!l I

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25 NEAL R. GROSS COL AT aFOATEAS AND TR ANSCRIBEas i

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that we agree?

)

2 MEMBER SWANSO:

So moved.

l l

3 CRAIRMAN SIEGEL:

Is there a second?

(

)

4l MEMBER WAGNER:

Second.

i 5

CHAIRMAN SIEGEL:

All in favor?

l 1

1

)

l 4

6l (Whereupon, there was a chorus of " Ayes.")

li i

l 7ll CHAIRMAN SIEGEL:

Any opposed?

8lll l

(No response.)

I

{

i 9

CHAIRMAN SIEGEL:

You got it, u

10l!

DR. GLENN:

Thank you.

We will make that l

I 11 ' correction in the paper, and it will now be 100 percent

.l 12;j accurate, j

13 (Slide) l 14 '.

DR. GLENN:

The next rulemaking I want to 15 discuss is patient release criteria.

I'll just mention

16., that the work on these two rules is by Steve McGuire and 17 Stewart Schneider.

And if we run into any difficult i

18!

queations, I will ask them to respond to them.

L 1 91 I think one of the areas that might be most 200 controversial -- I think, again, you approve of the The approach is that we're going to a

'l approach.

21: '

22l dose-based release criteria for patients that's based on i

23' 500 millirem to members of the public as a result of l

24 release of the patient.

I think where you may have some 25 disagreement is in terms of the guidance and how we are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHOOE 1SuND AVENUE. N W (202) 234 4433 WASHINGTON. O C 20005 (202) 234 4433

513 1

going to implement the rule.

2

'I-think one of the= issues that might be1of I

i 3

some1 contention is recordkeeping.

Currently as drafted 4;

and with some small changes in the language because I 5'

don't think it's clear in all cases what the recordkeeping 6

requirement is -- but our intent is to require a record ifj i

7.

the basis for the release of the patient is not the l

i 81 quantity administered -- I'm sorry -- if the quantity 9

administered exceeds the quantity in the default release 10 table in the regulatory guide.

What that translates into f

11{ is that if it involves any assumptions other than point i

12 source, 25 percent time spent at one meet, and that it's 13 physical decay only, then you have to document the basis 14lIl on which the patient was released.

i 15j)

What's not explicit in the rule language but o

i 16dwhichis, I think, implicit is that it also means that if l

f l

17' instructions are required because the patient is a i

18 breast-feeding woman, that a record would also need to be 19 kept to demonstrate that that was done and that i

i l

2 01 instructions were given.

21 CRAIRMAN SIEGEL:

Say that again, John.

You I

22l lost me, i

23 DR. GLENN:

There will be another table -- and 24 we'll get to that later -- that discusses quantities of 25 material that may be administered to a breast-feeding NEAL R. GROSS COURT REPORTERS AND TRANSCR$ERS 1323 AMODE ISLAND AVENUE. N W

,202) 234M33 W ASHINGTON. D C 20005 (202) 234 4 33

514 1

woman that would require that instructions be given in 2

order that the child not receive a dose in excess of the 1

3 public limit, which is the 500 millirem.

In those cases i

4l where that is required, then a record would need to be 5:. kept.

l i

il 6i CRAIRMAN SELIN:

Can I interrupt?

I T

DR. GLEN:

Sure.

J d

8i CHAIRMAN SIEGEL:

Of course, you can f

i 9

interrupt.

l' l

10j!

CHAIRMAN SELIN:

I say good morning to you I

11'! all.

d l

12 CRAIRMAN SIEGEL:

Good morning.

How are you?

y 13 '

CRAIRMAN SELIN:

I'm sorry.

Ineedtorunofff 14, this afternoon.

i 15 CHAIRMAN SIEGEL:

We wanted to have a l

16 ; 10-second opportunity to wish you well and to say how much I

17! we've enjoyed working with you and appreciate the spirit l

l 18 in which the NRC has treated the ACMUI over the last four

.i 19!.

years.

What else can I say?

CHAIRMAN SELIN:

That's not bad.

Thank you 20 21; very much.

But the Committee has been extraordinarily 22, helpful as we try to figure out what we want to do about i

23 medical work.

24 I guess if I were going to say one thing, 25 which obviously I am going to say, it would be to sort of NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 AMODE ISLAND AVENUE. N W QO2) 2344433 W ASHINGTON. O C 20005 (202) 2344433

515 1

help us with some of these larger questions that we come i

2 by.

As you know, thestaffistryingtore-engineeralotl 3

of the Part 35 and related items.

If we get something out i

4 of the National Academy e*.udy, that will be nice, but no l

5,- one is foolish to have some people go away, come back two l l

6l years, and count on anything explicit coming back.

I 7j So I do hope that you will not just look at 8!' the specific pieces but do a kind of overall Gedanken i

1 9

experiment, you know, "If these were, in fact, the rules ilJtoday, how would they work?" since you bring not only your 10 II 11; professional knowledges, experts, but as practitioners, l

12l and to help us run through how these items would work.

n 13!!

This is not a Commission-level committee.

So 14 I can't give you a charge, but if I were to give you a 15 charge, it would be to look at the overall Part 35 or the h

16j changes that we're talking about and try to see how they j

17 interconnect with each other.

And as practitioners would i

i 18h your lives be significantly easier if we do these things? I I

19l And put yourselves in the shoes of the patients.

Would 20' the patients be any better or worse off if we did this?

21j CHAIRMAN SIEGEL:

I actually think we figured l

i 22l that charge out already and are eager to attack those 23 tasks.

24 CHAIRMAN SELIN:

Very good.

So this Committee 25 has been a lot of fun for me.

I can't say that metaphor NEAL R. GROSS COURT AEPORTERS AND TAANSCRIBERS 1323 AMODE ISLAND AVENUE. N W

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regulation has been a lot of fun.

This Committee has been 2

a lot of fun for me.

And I have enjoyed it.

I have i

l 3

enjoyed it very much.

f 4

By the way, there is one major thing that l

l 5;l we're thinking of doing that would be very helpful.

I i

61 would like to see the agency get out of the business of f

7 qualifications of professionals.

I just don't see that we 8

need to do that.

I don't think we need new legislation to 9,

do that.

I think that we could do with in our current i

lof piece.

And that's one thing the staff is going to be I

11 looking at, which goes far afield in terms of innovation

'l 12qcomparedtotheotherpieceswhicharemoremechanicalor h

i 13H logistical pieces.

l 14 So we have three pieces.

One is:

Is it a i

l 15 - good idea?

I mean, do we have anything to contribute at 16 themarginbysayingwho'saqualifiedphysicianifyou'rej

-l ri Board-certified?

Who's a qualified technician?

And 17"!not 18i do we really let the endocrinologist tell us what a 13 qualified cardiologist is and vice versa?

20i The second question is:

If we don't do it, do l

21f we have to make some changes so that other people will, in 1

22 fact, make responsibility for errors of omission?

There's I

23'l always somebody to take responsibility for errors of j

l 2d commission, but does somebody fall between the cracks?

25 And the third is to look ahead in the world of l

NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W 202) 234 4433 W ASHINGTON. O C 20005 (202) 234 4433

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J

517:

1 gamma knives and other new technology, is it more 2

important or less important that we be involved in l

3 deciding what it takes for people to be qualified or who j

4 would qualify?

And that would be very helpful.

5 You have an extraordinarily varied group.

l l

6 It's much more of a representational group than just five i

7 people who know a lot about reactors or waste, and I think!

l 8

it would be very helpful to the staff.

l 9

So I'm sorry I can't stay longer either this q

l

\\

n 10 morning or at the NRC, but, in any event, thank you for lifthosekindwords, Barry.

Thank you very much.

l f

12 CHAIRMAN SELIN:

What were you talking about, 13l John?

I 14 pll l

DR. GLENN:

We were talking about release of 15j patients.

I i

16j I think we have another Commissioner.

17 CHAIRMAN SIEGEL:

We're doing very quick I

\\

18 interviews here.

19l DR. GLENN:

Barry, do you want her to come up I

I i

2 01 now?

1 i

I 21 CHAIRMAN SIEGEL:

Please, Gail.

I 2 2.,

COMMISSIONER de PLANQUE:

Hi.

23 CRAIRMAN SIEGEL:

Hi.

Welcome.

24 COMMISSIONER de PLA'.,QUE:

How are you?

25 CHAIRMAN SIEGEL:

Fine.

We wanted to see if NEAL R. GROSS COURT AEPOATERS AND TAANSCAtBEAS 1323 AHOOE ISLAND AVENUE N W 202) 234 4433 WASHINGTON O C 20005

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we could capture you for two minutes --

2 COMMISSIONER de PLANQUE:

Sure.

l 3

CHAIRMAN SIEGEL:

-- to tell you how much i

I 4

we've all enjoyed working with you.

I 5

COMMISSIONER de PLANQUE:

Thank you.

6 CHAIRMAN SIEGEL:

We really appreciate your 7

special interests in the Medical Program.

It has been a 8

pleasure.

We wish you well.

That's really it.

And we'd 9i welcome any sage advice you want to give us in 30 seconds l l

I 1 01 or less or even longer.

s U

I 11; COMMISSIONER de PLANQUE:

The sage advice i

I l

12ll would be you serve an extremely important purpose to the l

3 I

13fCommissionandforourregulationinthemedicalarena.

14q And sometimes you may feel that your messages aren't beingl 15.

heard, but I think they are.

16 '

We do get the reports of the meetings, and we q

1 71 really value all your input because you are our contact q

18!! with what's going on on the other side of the wall.

19 It's extremely important that you continue to 20 voice your opinions, your conclusions, your advice.

When 21j there are key issues and you think we might not be getting o

22!i your attention directly, well, then try to get our 23 attention directly.

But it's extremely important that you 24 do give us your input on everything that's going on.

25 You know, of course, we're reevaluating the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE rSLAND AVENUE, N W (202) 234 4433 WASM!WITON O C 20005 (202) 234 4433

53 1

entire medical regulation.

And it's not quite clear what 2

the outcome will be.

I think at this point we're and 3

I'm sure staff has told you that we're waiting to see what 4

the academy will say.

And dramatic actions will occur as {

5 a result of what they might say, what we think of the 6

result.

f 7!

And, try as we might, we haven't been able to !

i 8

get them to spill the beans and give us some sort of i

9; preview as to where they're going.

So it's really hard tol 10 tell at this point, but we're certainly looking forward to!

I I

11 that.

12 By the way, there was a very interesting piece

'i 13 on NPR this morning about errors in the medical ccmmunity.,

14I If you haven't heard that piece, you might be interested i

15H in hearing it because it did provide some perspective with d

16' other areas of medical and what kind of errors you might 17 expect in the endeavor of trying to make comparisons.

Sc 18, we sent for the text of that.

We think it's of interest.

19 If you don't see it any other way, it's just one more bit I

20 of information that might be of interest to you.

i l

21l But I certainly have enjoyed very much getting 22 the results of your meetings.

I haven't met all of you 23 personally, but I've seen many of you.

And we certainly 24 appreciate your work.

25 CHAIRMAN SIEGEL:

Thank you.

NEAL R. GROSS COUAT REPORTERS AND TRANSCRIBERS 1323 AHODE ISuND AVENUE. N W q202) 234-4433 W ASHINGTON. O C 20005 a02) 234-4433

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COMMISSIONER de PLANQUE:

Thank you very much.:

i 2

Good luck.

3 CHAIRMAN SIEGEL:

You, too.

Thank you.

I l

4i DR. GLENN:

Barry, did I answer your question Si or not?

6 CHAIRMAN SIEGEL:

I'm not sure.

If there's by 7

the table, which is as yet incomplete in the work that we 8

saw, --

9 DR. GLENN:

Right.

l i

1 01 CHAIRMAN SIEGEL:

-- if you're in the range l

11l between 100 and 500 millirems if the patient is, in fact, I

i 12l breast-feeding, then do you need a specific record or 4

I isn't that the parallel situation to being within the 13.

'l 14j 100-500-millirem range for using Table 1?

i i

l 15ll I think the distinction in the rule as it's 16 now written is that if you're between 100 and 500 1

millirem, you have to give instructions and you have to 18ll keep a record if you made the judgment based on something I I

' 19l other than the table.

20i DR. GLENN:

Other than the table.

21j CHAIRMAN SIEGEL:

So that if you're making 1the.

i 22.

judgment that a breast-fed infant is going to get less 23 than 500 millirems based on the table, then you shouldn't 24 have to make a special record.

25 DR. GLENN:

Then it should be only in those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 2344433 WASHINGTON. O C. 20005 (202) 2344433

52; 1

cases where it would exceed the 500 if --

i 2

CHAIRMAN SIEGEL:

Unless you did it byspecialli 3

calculation.

l 4!

DR. GLENN:

Yes, yes.

d, SU CHAIRMAN SIEGEL:

Do you all agree?

Because l

6 this is key because otherwise we've got more paper that we 7!

don't need.

i 8!

DR. GLENN:

It makes sense to me.

Now, I'm 9

trying to remember in the discussions we had with NMSS 10 yesterday --

11!

CHAIRMAN SIEGEL:

Because that's truly not i

12fclearinthetext.

J 13 DR. GLENN:

Yes.

And, Larry, I think the i

14 question is for the breast-feeding woman where it's

(

15l between 100 and 500 and where instructions would be i

t 16q; required, would we require a record if it's in that l

1 71 interval?

l I

18 Clearly below that we don't require a record.

19 Above that we do require a record.

But there is this gray 2 01 zone.

I I

21; MR. CAMPER:

We were taking about written

)

22 instructions being provided.

23 DR. GLENN:

Yes.

24 MR. CAMPER:

But I don't necessarily recall 25 that we talked about a record be maintained of.

No, I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHQDE ISLAND AVENUE. N w i200 2344A33 WASHINGTON. O C 2000$

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f

[hs h)

.s 1

don't think we were right at that point.

Frankly,'it's mW 2

not clear to me why we'd need to have that.

3 DR. GLENN:

Yes.

So"it-~really should becif;#'

i 4i the criterion.for release requires a recommendation'of l.

5 cessation that that should require a record.

And I think l 6l that's appropriate.

a.;

7f I

CHAIRMAN SIEGEL:

Dennis?

i 8

MEMBER SWANSON:

A comment or a question.

In l

9, the first point you have, you require a record of the 10j basis for release if the quantity administered exceeds the:

1 11 quantity in default release tables in the regulatory I

12 guide.

Is that really what you mean?

Because I didn't 13ll interpret reading this as scud.

t.

14q DR. GLENN:

That's not what it says, but I 15q think that is what we concluded in our discussions with k

9 16 NMSS earlier this week that is wanted.

In other words, ifj 3

i 17h the written directive or the record of the dose a

il 13i administered is not in and of itself a sufficient basis 1

19l for release of the patient, then there can be many simple i

20l ways to include information that supports the release.

21 But there does need to be a written record that tells what 1

22!

the other factors are.

23 MEMBER SWANSON:

But it was my understanding 24 that you didn't have to have recordkeeping if you released 25 the patient based upon these tables.

NEAL R. GROSS COURT AEPORTERS AND TAANSCRIBERS 1323 AHODE ISLAND AVENUE. N W (202) 234-4433 WASHINGTON. D C 20005 (202) 234 4433

523 1

DR. GLENN:

Table 1.

That's correct.

i

,_ MEMBER _SWA$5bN:

2 But the Table l's a upon tNe quantity of the material in the patient 3

at the i.

' time of release, not the quantity administered.

5 CHAIRMAN SIEGEL:

s

\\w

{

s_

6 DR. GLENN:

But if you do hold the patient j

7 before you release them, then there needs to be a record 8I that they were released one day later and that the i

9 activity had decayed.

That's what we're saying, that a j

10 record of that fact needs to be there.

Otherwise there's l l

11 nothing to tell us that, in fact, youdidholdthepatientf 12; for the extra day.

l i

13l CHAIRMAN SIEGEL:

Here, in fact, is thes

~ '

a-3 l

.i l problem.

The problem is that 35. 75 (c); says that ~ ^you~need l14 i

15,l a record under those circumstances where the calculation i

il 16 was based on something other than physical half-life, 25 17 percent occupancy, and a meet.

And that automatically 41N, puts all breast-feeding infants into that category because i

s 19 it's based on considerations of things like excretes.

20!'

So I'm now wondering whether you can figure I

21; out a way to --

22 DR. GLENN:

And we realize that wording has to 23 be changed.

24 CHAIRMAN SIEGEL:

You really don't want i

25 records of all of those.

NEAL R. GROSS COVAT REPORTEAS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE. N W i?c2) 2344433 W ASHINGTON D C 20005 (202) 234 4433

N 524 1

DR. GLENN:

We don't want all of those i

2 records.

And also we didn't catch the situation that l

l 3

Dennis was just talking about necessarily with the way I

I 4

it's worded.

So we realize that wording needs to be tuned l l

r 5

up.

6 The two criteria I had up there before are the i

7 ones that we essentially agreed to with NMSS earlier in l

l 8

the week.

However, I think we need some fine-tuning on j

9 the second one that it doesn't cover the 100 to 500.

10)

And getting the wording right in (c) is going i

11 to be a challenge.

We realize that.

l I

12l' CHAIRMAN SIEGEL:

What about putting the table t

13l in the regulations?

I mean, obviously it won't capture i

14jeveryisotopeknowntomanthatmight ever be used in

.I 15:1 medical therapy, but if the tables are part of Part 35, i

16g then it's easy to refer to the table.

Then you leave less l 17 up to judgment.

18 MR. CAMPER:

As an appendix or something?

19 CHAIRMAN SIEGEL:

Well, as an appendix to Part 20 35.

I mean, there are plenty of other things.

You've got 21 those long tables of annual limits of --

l 22l DR. GLENN:

It's something that we can take a 1

23 look at.

There are always problems when you put

)

24 information in that may change depending upon the 25 technology and this sort of thing.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RMODE ISLAND AVENUE. N W l202) 2344433 WASHINGTON. O C 20005 (202) 234 4433 J

l 325 l

1 We'd like to keep it in the guidance document,;

2 where it's easier to revise, but we'll consider that.

3 That would make it very simple to describe --

4 CRAIRMAN SIEGEL:

To deal with the A

5 breast-feeding problem.

6l DR. GLENN:

Yes, right.

I, 4

7 CHAIRMAN SIEGEL:

Okay.

8 MEMBER FLYNN:

Can I ask a question about --

l 9

DR. GLEN:

Sure.

l 10 MEMBER FLYNN:

I'm not sure I understand.

Thel 11l iodine 125 l

implant, the 8.7 millicuries, that's the total l 12l activity?

13l DR. GLENN:

That would be the total activity.

14ll MEMBER FLYNN:

And if a patient has greater 1, l 15, than that activity implanted in them, they may not be i!

16, released?

i I

i 17 DR. GLENN:

No.

But what it says is that if 18d they have more than 8.7 millicuries in them, that you will i;

19hneedtohaveanotherbasiswhichisdocumentedinarecord 20l for determining that the dose to an exposed member of the l

21.

public would not exceed 500.

22h CHAIRMAN SIEGEL:

But which actually will be 1 m 23 consistent with what you're probably doing already because 24 the regulatory guide has a dose rate that you can use as 25 the basis for letting them out.

j NEAL R. GROSS COUAT AEPOATERS AND TAANSCAIBERS 1323 RHOCE ISLAND AVENUE, N W 4202) 234 4433 W ASHINGTON. O C 20005 s202)2344433

526 1

DR. GLENN:

Right.

2 MEMBER FLYNN:

Because thousands of prostate l

l 3

implants are being done.

And the dose rate might be 4

roughly.2 millirem per hour to meet.

5ll DR. GLENN:

And the table does, in fact, say i

6 that.

But.bythewayweare*planningto: write.th$f l

j r

78 recordkeeping requirement, youwouldberequiredto' record!

i S

that you measured the dose rate and that it was below the ;

9 value on the table.

10 Just before we remove this, one thing I'd likei 11 to note is that for most isotopes, in fact, the default 12 release criteria in terms of activity are higher than the 13hcurrent restriction, which is 30 millicuries.

So there i

14!

are just a few isotopes where it is more restrictive, 9

6 15l iodine 125beingtheprimeexample.

I 16]

CHAIRMAN SIEGEL:

I can't imagine what it l

17f would cost to give someone 240 millicuries of gallium-67 18l or why I would want to do that.

l j

I i

1 91 DR. GLENN:

One question that has come up in l

i 20!

the concurrence process and we would like a little bit of

\\

l 21, comment from the Committee, the current wording would say l

22!

" Instructions, including written instructions, on how to 23 maintain doses to other individuals as low as reasonably i

24 achievable."

25 I believe at the last meeting there was a NEAL R. GROSS COURT REPORTEAS AND TRANSCRIBEAS 1323 AMODE ISLAND AVENUE, N W 202) 234 4 33 W ASHINGTON. O C 20005 (202) 234 4 33 J

5:~

1 discussion.

There was clear instruction to the staff not i

l 2

to say "only written instructions."

But do you see a i

3 problem with our saying " written instructions"?

4 I guess in the staff in discussing it, 1

Sj sometimes being patients, we think that sometimes, as wellj i

6 as you doctors communicate, by the time we get home we may!

7l not remember everything you've told us.

And, therefore, a 8

written instruction that can be referred to either by the )

9 patient or the family member is a very reasonable thing.

l 10 CHAIRMAN SIEGEL:

In fact, we agreed.

And I t

I 11hthinkthat language is the language I suggested.

So I 12 obviously agree with it.

l 13l MEMBER FLYNN:

I agree.

And that's being done{

i i

14u for the prostate implant patients, and appropriately so.

l i

i 15ll CHAIRMAN SIEGEL:

Yes.

I think this is fine.

j it I

16.

MR. CAMPER:

Okay.

Thank you.

l i

17l CHAIRMAN SIEGEL:

And this is people need laf something they can study, and they also need to hear it.

19l They need both.

20 DR. GLENN:

Okay.

In the current regulations 1

21j in 35.315 and 35.415, which are in sections entitled

{

l 22ll " Safety Precautions," there are requirements to provide 23 instruction to keep exposures as well as reasonably 24 achievable.

25 We have revised those sections to include NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W

.202) 234 4433 WASHINGTON O C 20005 (202) 2344433

523 1

language that now refers back to 35.75(b).

Clearly on thei 2

face of it it is redundant.

And we have two choices or i

3 three choices.

We can either delete those sections as no i

4 longer being necessary since we have a requirement for i

l 5

instructions in 35.75.

We could keep this as a way to j

i 6

have two sections that remind people that really ALARA is.

1 7

an important concept or we could leave them in there but

{

8 not refer back to 35.75 but just say in general principles 9

anyone who is undergoing a therapy implant or l

10 administration, that you should provide instructions for 11l keeping exposures ALARA.

12 CHAIRMAN SIEGEL:

Are they in conflict in any i

13 way?

141 DR. GLENN:

They're not in conflict.

They're t

15!{ redundant.

16l CHAIRMAN SIEGEL:

Yes, especially since you'rej 17l saying if required in 35.75(b).

18 DR. GLENN:

Right.

I 19l CHAIRMAN SIEGEL:

I mean, the truth of the 20l matter is to be ALARA, you really ought to delete that I

21}

phrase, but I'm not recommending you do.

22 DR. GLENN:

You're not recommending we do it.

23 That was one question.

24 CHAIRMAN SIEGEL:

That's what I'd do.

25 DR. GLENN:

Yes.

j NEAL R. GROSS COURT REPOATEAS AND TAANSCRIBERS i

1323 RHODE ISLAND AVENUE. N W 42C2) 2344433 WASHINGTON. O C 20005 (202) 2344433 l

529 1

CRAIRMAN SIEGEL:

But that doesn't mean it 2

ought to be a regulation.

3 DR. GLENN:

But it doesn't need to be a i

I 4,

prescriptive requirement.

g 5>

CRAIRMAN SIEGEL:

Correct.

I 6

DR. GLENN:

Do you think leaving it here might I

7!

encourage people to go that extra mile, even in those 8

cases where they wouldn't be required to?

l 9

CHAIRMAN SIEGEL:

I don't see this as hurting.

+

i 10 This is pretty neutral.

I 11l (Slide)

I i

'l 12j DR. GLENN:

Okay.

This is a trial balloon.

i l

t 13 ! This is a table that we did not include.

We have had many!

14 requests, and NMSS has stressed to those of us in research l

153 the need to provide some default tables for iodine 131 as t

16; sodium iodide.

17l Now, we are asking for your advice on the best 18g way to present this table.

I had envisaged it as being a 19 table of defaults depending upon the fraction of uptake in 20l a given patient.

When I asked the staff to calculate it, 21]

there were more variables involved than I had anticipated.

22!

I had not anticipated that the biological half-life is a 23 function of uptake and things of that nature.

So the kind 24 of table I envisaged is a little more difficult.

25 So what I did ask them to do is for --

NEAL R. GROSS COURT AEPORTERS AND TAANSCAIBERS 1323 ANODE ISLAND AVENUE. N W

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i 533 1

CHAIRMAN SIEGEL:

That still is ignoring 2

attenuation as well.

3 DR. GLENN:

This is ignoring attenuation.

The 4

only thing we have taken into account is the biological i

t i

Sj excretion.

t 6

CHAIRMAN SIEGEL:

Right.

I 7l DR. GLENN:

What I asked them to do is l

i Bl calculate it for a 100-millicurie dose so that essentially I

i 9, you can multiply it by a factor.

If it's 30 millicuries, 3

d 104 it's 30 percent.

And so that it's an easy calculation to !

i' 1

i llo do.

And this way the assumptions that we've made are I

h i

I 12j transparently clear as we go across.

l 13h Now, there is another measure of conservatism,'

.l o

14[ other than not accounting for attenuation.

And that's l

151 that column after "Eight Hours."

Because we're talking j

't j

15; about.up to hundreds of millicuries of iodine in a' l

17 patient, the assumption of only 25 percent of the time t

18l being close_to the patient in the early hours before'the l

l#

1 91 biological excretion.has taken place is not necessarily a 20 good assumption.

t 21!

.So we.have assumed for the>first-8-hours that, 22 in fact,-'it is-100 percent within one meet'.

So that would#

23

. account for-people-who are in cars,-being transported ^

24 home, perhaps being on the~' metro going--home.

So the 25 conservatism built in for the first 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> is 100 percent NEAL R. GROSS COURT RE*ORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 234W WASHINGTON D C 20005 1202) 234 4433 s

5 2 '.

1 within one meet.

From that point on it's 25 percent of 2

the time, as in the other calculations.

l 3

I believe that for this purpose we put this 4j table together rather quickly, that we haven't accounted L

i si' for the biological elimination during the eight hours.

6 During that eight hours it's only physical decay.

Then

7) from then on we take in the biological.

So these numbers I

l 8,1 would actually decrease some.

i 9l MEMBER NELP:

Your total dose is over what?

10 What's the time base for the last?

l i

l i

11;,

DR. GLENN:

That's to decay.

Rather, that's j

fl l

12H infinity.

I

?

l 13!

CHAIRMAN SIEGEL:

Integrated to infinity.

l 14]

MEMBER NELP:

And the individual is within?

l 15 '!

I DR. GLENN:

One meet.

l 16 :;

MEMBER NELP:

One meet, at one meet?

I i

17 DR. GLENN:

At one meet, yes.

18 MEMBER WAGNER:

By that table, am I correct in i

19 assuming that if one used this table alone, one could then 20!

use a release criterion of 50 millicuries because your I

21l total dose never exceeds one rem?

So 50 millicuries would 22 be 500 millirem.

And apparently the release criteria --

23 CHAIRMAN SIEGEL:

You can use a release for 24 thyroid cancer.

You can use a release criteria of --

25 DR. GLENN:

Even higher.

NEAL R. GROSS COURT REPORTERS AND TRANSCAIBEAS 1323 AMODE ISLAND AVENUE. N W 6202) 234 4433 w4SHiNGTON. D C 2000$

(202) 2344433

532 1

CHAIRMAN SIEGEL:

-- 200 millicuries.

2 MEMBER WAGNER:

Well, correct, but, I mean, 3

the table itself would suggest.that any --

4 DR. GLENN:

That 50 would always'be'saf61-5 MEMBER WAGNER:

Would always be safe.

6 DR. GLENN:

I think that that would be a 7

proper conclusion.

8 CHAIRMAN SIEGEL:

But it is higher.

I i

l 9l, DR. GLENN:

Yes, it is higher.

1 01 MEMBER WAGNER:

Currently in.the table they're-11]

only:. listing 33.

And what/I'm' suggesting is._that maybe i

~

12 ~ Table 1 could be changed based upon this-tabld.

l j

13l

-CHAIRMAN SIEGEL:

I'think that'sethe whole i

f 1

14j -point, whether this tabl'e would potentially go in as a l

15 & substitute.

16 DR. GLENN:

Now, the only additional

1 ~7 requirement I would think if we used this table is that.

18.there would need to be a record of the fraction taken up'

'19

.in the thyroid.-,*

1 20!

MEMBER NELP:

Which would be ordinarily be --

21 CHAIRMAN SIEGEL:

Ordinarily, right.

22 DR. GLENN:

Ordinarily, yes.

23 CHAIRMAN SIEGEL:

Some people do treat 24 empirically, but most do not.

25 MEMBER NELP: -So this means that using this NEAL R. GiFh3SS COOHf AEPORTERS AND TRANSCAl8EAS 1323 AHODE ISLAND AVENUE. N W (202)2344433 WASHINGTON. O C 20005 (202) 234M33 i

533 1

criteria because I sort of got in on the second act or the 2

third act of this play, at a 150-millicurie thyroid cancer 3

dose, you could document, record all of these things.

4 This would indicate that ordinarily that individual could 5

be released without hospitalization.

6 CHAIRF93 SIEGEL:

Yes.

7 DR. GLENN:

Again, in using this table, the 8

important thing is that you would know that the fraction 9l of the thyroidal component was less than five percent.

10 CHAIRMAN SIEGEL:

And that may be a problem, lih Buzz, because you don't, most people don't, measure the h

I 12htotalbodyretentionfractionbeforetheytreat a patient 13 with thyroid cancer.

Most people do a scan with 5 14] millicuries, see what the picture shows, and either give 1

15]them100, 150, or 200 millicuries, depending on where the 16llmetastasesare.

17 MEMBER NELP:

Yes.

Most people --

18 CHAIRMAN SIEGEL:

Few people make 13 measurements, but most don't.

20 MEMBER NELP:

Most people could make an 21j assumption which would be very conservatively high.

l 22l DR. GLENN:

Yes.

I guess there's some 23 guidance on what would be an equivalent establishment that 24 it's going to be five percent or less.

I guess that's my 25 understanding that in almost every case it will be five NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W

.202) 2344433 WASHINGTON. O C 20005 (202) 2344433

534 1

percent.

2 MEMBER NELP:

Very frequently it is, but there 3

are exceptions.

I 4

DR. GLENN:

Okay.

In the guidance we pointed 5

out that if a-patient is-in renal failure, you wouldn't=be^

l 6

.able to use this table.

j l

l 7

MR. CAMPER:

Yes, right.

You would need to I

8 bring to bear specific factors and step through the i

9 analysis for that particular patient.

l I

i 10 MEMBER NELP:

Well, you do have the capability' lli of measuring your eight-hour dose or measuring the dose l

i f

12 from the individual with year own survey meets.

l 13f DR. GLENN:

Yes.

That's always an option that 14 if you --

o i

15' j CHAIRMAN SIEGEL:

Yes.

But you can --

i 1 64' DR. GLENN:

-- at the time the patient is l

l i

17l walking out the door, you make a measurement that's lower t

t 18!

than the value in Table 1.

19; CHAIRMAN SIEGEL:

But if it's 150 millicuries, l

20 it ain't going to be below 7 millirems per hour if you i

l 2 11 just gave the dose a few minutes ago.

It's going to be l

j 22l higher than that.

23 MEMBER NELP:

I'll use the table.

24 DR. GLENN:

Okay.

Now, is this an okay format 25 for the table or would you rather see it where for a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE N W

$202) 2344433 WASHINGTON. O C 20005 (202) 234 4433

535 1

thyroidal component, fraction F,,

we actually did the t

2 calculation and said what the maximum activity could be?

-3 MEMBER NELP:

I'think you could simplify the, 4

language _ a little~ bit'.

Instead of. calling it'- -more.,,

.5, traditionally you say a thyroid uptake percent remaining 6

in the body.

7 DR. GLENN:

But here we are assuming you're 8

going to do a little bit of math, you're going to take 9

whatever administered activity you get, divide it by 100 10 and then multiply by that fraction.

l 11' CHAIRMAN SIEGEL:

Why not just reduce the 12 whole table to per millicurie?

13l l

DR. GLENN:

Okay.

Rather than do it as a

~ 4 14, percent, but d

15 CHAIRMAN SIEGEL:

And then make the dose in i

16' millirems, rather than in rems.

17 DR. GLENN:

Yes.

j 18 CHAIRMAN SIEGEL:

Because you've also got 19l confusing things.

Right._now hyperthyroidism ~100 j

i 20 millicuries ~doesn't make sense.

That would-be a whopping 21

_ dose for the treatment of_ hyperthyroidism.

But just 22-thyro'id' ablation would be fine, and then you could just i

l 23 say per millicurie, but-thyroid cancer you're giving --

l 24 DR. GLEN:

Sort of a nominal value is what we 25 chose to do there.

NEAL R. GROSS COURT REPORTERS AND TRANSCRtBERS 1323 RHOOE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. D C. 20005 (202) 2344433

53{

1 CHAIRMAN SIEGEL:

Right.

And that's actually 2

a conservative value.

3 DR. GLENN:

Yes.

6 4>

MEMBER NELP:

But that actual in terms of I

5!

convenience if you rounded that off to 100, it would make 6

it implicitly a little simpler to calculate.

But it's not !

7l a big deal.

i 8

CHAIRMAN SIEGEL:

But if it was millirem --

9 MEMBER NELP:

I could handle --

l I

10)

.CRAIRMAN SIEGEL:

-- millirems per millicurie,j, l,

l li instead of rems per 100 millicurie, it actually -- I mean,I 12 we're used to working in those units, millirems per I'

i 13!! millicurie or, if you will, millisieverts per mega l becquerel,Godforbid.

14 a

15]

DR. GLENN:

That's easy enough.

'l t

16.,'

CHAIRMAN SIEGEL:

I like that addition.

l 17l DR. GLENN:

Okay.

I 18l CRAIRMAN SIEGEL:

And I think you'll find 19 people defaulting to that a moderate amount.

20' DR. GLENN:

It still has a lot of conservatism 21 into it, but I think it certainly takes care of most cases 22 where you'd want to be related to the patient.

23 Now, one thing we want to raise to you:

24 Should we in the guide raise the issue that, in fact, with 25 these kinds of activities in patients, the potential for 1

NEAL R. GROSS COURT AEPOATEAS AND TAANSCRIBE AS 1323 RHODE ISLAND AVENUE. N W i202) 234 4433 WASHINGTON. O C 20005 (202) 2344433

537 1

contamination is rather high, even though the doses that 2

we would calculate to members of public would be small?

)

i 3

But you do have a high potential of contamination of

\\

4 facilities.

Should we mention the possibility that it 5

would not be a requirement but a suggestion that forthesei 6

higher activities maybe you want to hold the patient untili 7

the excretion has taken?

l u

8!

CHAIRMAN SIEGEL:

Something in the guidance 9

document pertaining to patients who are incontinent, i

10 nauseated, vomiting, et cetera, that ALARA considerations 11 warrant adjustment of what you do based on the medical 12 ' ' circumstances.

And that's a true statement.

i i;

is i

13]

DR. GLENN:

Okay.

Yes.

14 P MEMBER NELP:

Under these guidelines, the only I

15 reason you'd keep a person in the hospital was if they 16l were unable to care for themselves appropriately, but l

l 1]

they'd be ill.

I 1

DR. GLENN:

If you don't have an expectation I

19l that they can follow the instructions and that sort of 20! thing.

I 21!

CHAIRMAN SIEGEL:

Buzz, do you think you'd

\\

2 21 send someone?

Now, the table says you can do it.

Would 1

23l you send someone out the door with 150 millicuries in?

24 MEMBER NELP:

Absolutely.

25 CHAIRMAN SIEGEL:

You would?

Would you wait NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE. W W i202) 234M33 W ASHINGTON. O C 20005 (202) 234 4 33

l 535 l

1 l

2 MEMBER NELP:

If they were --

l l

3 CHAIRMAN SIEGEL:

-- until they at least had l

4l absorbed it from the stomach and --

Sy MEMBER NELP:

Why?

i 1

6 CHAIRMAN SIEGEL:

-- urinated once or twice?

7l MEMBER NELP:

Why?

l l

81 CHAIRMAN SIEGEL:

I don't mean overnight.

9 Just keep them around for a couple of hours.

i l

10 MEMBER NELP:

I would see my own -- if you 11 want my personal answer to this, I would assure myself i

12 that they clearly understood what was going on, that they l s

!i 13),werecapable, they were self-caring, they had a good i

i 14 !: living situation to go to, they weren't going to be around 15 ;. infants and children.

But I don't keep in my office or my l

16 i domain --

i d

17 DR. GLEN:

So we should focus on the issues i

1 81 where there would be some concern.

19 MEMBER WAGNER:

There is one issue --

i 20I CHAIRMAN SIEGEL:

Lou?

21l MEMBER NELP:

There is one that I would I

22[

hesitate to do this with, but --

23 MEMBER WAGNER:

There is a major issue I think 24 that this is going to raise.

You're going to see this 25 after this sharpens, I think.

And that is we have had

{

NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. D C. 20005 (202) 233 4 33

533 1

several problems in the State of Texas with regard to i

1 2

weste facilities, conventional waste facilities, that pick 3 mup radioactive diapers, radioactive diapers from adult and i

4 _. children-type patients, but mostly adult patients who are j 5l released from our facility.

6 And this is going to raise that level of l

I 7,

concern.

And it will cause a problem as to how they're t

8 going to handle that issue.

l l

1 9,

MEMBER NELP:

I would hesitate to send a l

l 10 diapered adult home if they were --

11 MEMBER WAGNER:

I think with this situation i

12 now you're going to have more contamination of things that l

13 might get thrown away, and it may raise that issue.

14ll DR. GLENN:

I think we have documented cases h

i 15' where toothbrushes have, in fact, sent the alarms off.

16q MR. CAMPER:

We wrestled, as John pointed out, l'

171 amongst ourselves a lot with this issue, this table and 18 some of the release values associated with it.

But in the i

i 1 91 final analysis this is a dose-driven rule.

And you 20l shouldn't ignore a biological half-life.

And you l

21 shouldn't ignore dosimetry.

22 In many ways it places more responsibility i:

23' upon the licensees to be certain that you're not exceeding 24 the 500, that you go through the proper steps, but that's 25 probably where the responsibility belongs.

NEAL R. GROSS CO*JAT AEPORTERS AND TRANSCAIBERS 1323 AMODE ISLAND AVENUE. N W 6202) 234 4 33 WASHINGTON. O C 20005 (202) 234 4 33

~

54 1

MEMBER NELP:

What's the time line on this?

2 DR. GLEN:

Soon.

My last slide discusses 3

that.

The slide says July and August.

I'm actually l

4 pushing the staff to get it up in June. I would like to 5

have this Commission have a chance to review this rule.

6 Okay.

Next we have the table in terms of when 7

breast-feeding should be ceased or when instruction should 8

l be given to breast-feeding women.

The table is based on l

9 data that ORISE has generated for us.

And, again,'we have 10 a question about the format of the table.

What is the 11 best way to present it?

12 And, again, this table has been generated as 13 listing the nominal values and then saying " Instructions i

14j should be given?

Yes/no.

What would be the doses?

Is 1

I i

15 interruption recommended?

And for how long?" and that j

i' i

16 sort of thing.

17!

So the idea here is we sort of choose what we l

18; think about the doses that people would probably be i

19lladministeringandgivingtheminformationastowhat they l

l 20i should do in those cases.

l i

21l We can turn it around and do it.

This amount I

l 22l administered to the mother may result in 100 millirem.

23 And, therefore, instructions need to be given.

This 24 amount would result in 500.

And, therefore, cessation 25 needs to be considered.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j

1323 AMODE ISLAND AVENUE. N W i202) 234 4433 WASMNGTON. O C 20005 (202) 2344433

l 541 l'

CRAIRMAN SIEGEL:

This format here, personal 2

opinion, is very close to the format that has appeared in i

I 3

the published literature.

It's related, the procedures atj the radiopharmaceuticals to specific clinical procedures 4

r 5l.and provides quick guidance to a real procedure, rather 6

than in this case reducing it tomilliremspermillicuries{

7 administered to the mother.

I 8

I actually think this format in the table is 9,

more practical and people can then extrapolate from the 10 information in the table to the particular situation that 11 they're dealing with.

That's my opinion.

I I

12 MR. CAMPER:

Do you that that the 131, 150 13, millicuries at the top, has --

t 14 CHAIRMAN SIEGEL:

I think you need more than l

15j one entry.

In fact, you need three entries.

They're I

i f

J simple.

They all say the same thing:

I-131, 150 16 17 millicuries; I-131, 10 millicuries; and I-131, 30 to 100 1

18,!

microcuries.

And then all of them have the same i

19 recommendation.

20 DR. GLENN:

Okay.

21l CHAIRMAN SIEGEL:

You can't keep 22 breast-feeding with that much I-131, period.

Correct, 23 Lou?

24 MEMBER WAGNER:

Yes.

j 25 MEMBER NELP:

These data all come from the NEAL R. GROSS COURT PEPORTERS AND TRANSCRIBERS 1323 AMODE ISLAND AVENUE. N W e202) 2344433 WASMiNGTON. O C 20005 (202) 234 4 33

542 literature on I guess excreted material in the milk that's 1

2 been studied.

Is that correct?

3 DR. GLENN:

One thing I'll mention --

4 MEMBER NELP:

I'm surprised that sulfur 5

colloid is seen in breast milk.

That surprises me, but --

6 CHAIRMAN SIEGEL:

Sulfur colloid's not, but 7

the small amount of free reduced and free pertechnetate 8

is.

9 MEMBER NELP:

But look at technetium red 10 j cells.

That stuff is coming off of those cells very i

11!

rapidly.

You know, the half-life of tech on red cells is Ii I

12 20-hour.

It dilutes off very rapidly.

13f CHAIRMAN SIEGEL:

Not for in vitro.

In vivo u

i 14q is a problem.

j 13 15j MEMBER NELP:

No, no.

I mean in vitro.

Once 16 I it's labeled, then it dilutes off very rapidly.

17 CHAIRMAN SIEGEL:

I don't think so.

I 18!

MEMBER NELP:

Oh, yes, I think by ALAR T 1/2.

I 19 But, anyhow, I mean, that's been well-studied.

But I was 1

20i just curious.

It's not a big deal, but it seems unusual 21 that that would --

22' DR. GLENN:

Let me mention one thing.

We did 23 consider simply referring to USP.

Now, it's our 24 understanding that that may not be updated very frequently 25 and that we would have the advantage-here of having ORISE NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AMODE ISLAND AVENUE. N W (202) 234-4433 WASHINGTON O C 20005 (202) 234-4433

543 1

give us the most recent data that's available.

However, I 2

think in-the guide we would have to say "If there's l

3 something we haven't included here, that you could refer j

l 4

to the USP in terms of" --

i I

i Sj CHAIRMAN SIEGEL:

And USP actually got a l

6 little funky over the last few years.

USP used to include 7

pretty specific recommendations about cessation of 8I breast-feeding, and then they've more recently kind of 9.

dropped back to a generic statement and said the best way t

i 10 to be sure is to measure the activity in breast milk and i

11 became less helpful.

I I

12 And I think for the guidance you need here, 13[thistablewillservetheworldbetterwiththe 14j recognition that we have a responsibility to help you and !

lI I

i 15Hyouhavearesponsibilitytokeepthistableasup-to-date P

16j as possible.

17 DR. GLENN:

I will mention, I guess, that 18l there are still some holes in here, that those are being

?

19l filled, more isotopes.

20 MEMBER NELP:

Eighty-five percent of the stuff 21) is going to be technetium-labeled.

22 CHAIRMAN SIEGEL:

You don't have strontium-89, 23 but I don't think there are a whole lot of people who are 24 breast-feeding getting strontium-89.

But anything's 25 possible.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W i202) 2344433 WASHINGTON. D C 20005

<202) 234433

544 1

DR. GLENN:

I guess phosphorus-32 also.

2 CHAIRMAN SIEGEL:

Thirty-two is --

3 MEMBER SWANSON:

Both chromium and sodium 4

phosphorus.

5 CHAIRMAN SIEGEL:

Yes, alt. hough that's pretty 6

straightforward what the answer is going to be.

7 MEMBER NELP:

I think --

8 CHAIRMAN SIEGEL:

You can't buy it in the 9

United States anywhere.

-10 MEMBER NELP:

I think it would be a little. bit g

11 overkill if you wanted to -- you know, you could go 12 through every radiopharmaceutical that's available.

13 CHAIRMAN SIEGEL:

The problem is you can go i

14i through a lot.

You won't find published data for many 15,:

more than are in this table, having looked at this quite 16lj thoroughly.

17 MR. CAMPER:

That's right.

18 MEMBER NELP:

You've got thallium up there.

19 You don't have an answer.

Maybe is as commonly used as i

20l thallium today or maybe more commonly used is technetium.

21 CHAIRMAN SIEGEL:

It probably, yes --

l 22!

MEMBER NELP:

But-I'm not sure that -- you 23 know, thallium is-rarely used in a breast-feeding woman.

24 CHAIRMAN SIEGEL:

Well, there are at least 25 three published cases and phenomenal data at Washington NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON. O C 20005 1202) 234 4433

545 1

University on a case about three months ago, where we madeI i

i 2

measurements for a week and a half.

l l

3 MEMBER NELP:

After thallium?

l I

4}

CHAIRMAN SIEGEL:

Yes.

A patient who was 5

breast-feeding was done at another hospital and called us 6'

to say "They found out I was breast-feeding after they did 7

the test and told me I probably shouldn't feed for one I

i 8

feeding.

What should I really do?"

And I looked in the l

1 9

literature, and there was just inadequate guidance.

So wej i

10l got a bunch of samples.

11 After the first three days, it was clear that i i

12!

she could continue breast-feeding, but we asked her to 13 keep sampling, which she did for another eight days.

So j

14 we have a pretty complete profile.

l p

15J MEMBER NELP:

So you want to fill in the --

l t

i 16l CHAIRMAN SIEGEL:

I can help Stewart find the 17f

{)i' 18l

/

DR. GLENN:

You can help us fill that one in.

l l

19 !'

CHAIRMAN SIEGEL:

I have the references, yes.

I 20 DR. GLENN:

Okay.

l 21 MEMBER WAGNER:

Barry?

l 22i CHAIRMAN SIEGEL:

Yes?

23 MEMBER WAGNER:

As far as the utility of the 24 table, would it not be preferred to list the minimum i

25 activity at which the dose to the infant would exceed the NEAL R. GROSS COUAT AEPORTERS AND TAANSCRIBERS 1323 AMODE ISLAND AVENUE. N W (202) 234 4 33 WASHINGTON. O C 20005 (202) 234M33

546 1

permissible dose,s rather than list it the way we have it?

2 DR. GLEN:

So you're saying add a column, not 3

do away with this-table, but add a column?

l l

t 4

MEMBER WAGNER:

Yes, that's right.

That would

-5l give a lot of very useful guidance to. people because then 6,

you could go right down that table and say "Well, this is I

7h above that threshold" or "isn't."

il

(

Bj But the way it is listed now, one has to go 9l; through a calculation and try to do things.

And the 10 utility of the table is a little difficult.

11l MEMBER NELP:

That could cause you to go down l

1 21 and say "Well, I just won't give" i

i t

13l CHAIRMAN SIEGEL:

That's fine.

1 14h MEMBER NELP:

"the mother that much for il 15'l this test."

l 16 ~ l MEMBER WAGNER:

Yes.

i 17l MEMBER NELP:

"I could do the test with 1 81 one-third of the amount."

That's a good suggestion.

19 CHAIRMAN SIEGEL:

Okay.

That's fine.

20' MEMBER SWANSON:

I don't know if you want to 21-hit things now.

Some of the things just aren't available.

22{l Human albumin microspheres aren't available anymore.

23 Certainly I-125, hippuran, I don't know of anybody that's 24 using it.

It's not available.

25 MEMBER NELP:

I'm using it.

NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE. N W i202) 234 4 33 WASHINGTON, O C. 20005 (202) 234 4 33

547

-1 MEMBER SWANSON:

I-125, hippuran?

2 MEMBER NELP:

Oh, I'm sorry.

Hippuran, no.

3 Iothiolmate.

l 4

MEMBER.SWANSON:

Iothiolmate.

51 CHAIRMAN SIEGEL:

It's not on the table.

I 6

MEMBER SWANSON:

It's not on the table.

7I The dose for technetium white blood cells I'm i

8 assuming ~you're. talking about the examidasine label that's I

20 millicuries, rather than 5.

I can give you some more.

9 10 CHAIRMAN SIEGEL:

We would be happy to react 11 to this table and feed comments back to you when it's a l

i 12 little further along, whenever you're ready, since we l

13 didn't have this one.

And we'll get you additional f

i 14 literature to the extent -- I-mean, Lou has collected this 15 literature over the years, and so have I.

And I have I

i 16hgivenyoualotofit, Stewart, already.

17' DR. GLENN:

Okay.

We've already mentioned 18 schedule, July or August.

That's what the staff would 19 need in order to get I think the guide fully developed, 20 but I think we can have the guide in its next revision and 2 11 have the rule in final form in June.

And that's what I'm 22 pushing for.

23 CHAIRMAN SIEGEL:

Okay.

)

l 24 MEMBER SWANSON:

One comment on the guide.

25 There are a couple of statements in here; for example, "If NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 AHOOE ISLAND AVENUE. N W 202) 234 4433 WASHINGTON. O C 20005 (202) 234-4433

.3 54 B; 1

a radionuclide is, for example, a beta emitter, other l

2 pathways of exposure must be considered or need to be 3

considered.

The values in Table 1 do not take these other.

4 pathways into account."

And,.again, that leaves us kind 1

5 of open-ended.

6 It's also the statement at the end of it j

7f " Internal doses may be ignored in the calculations if they 81 are likely to be less than 10 percent of the external 9

doses.

They would be significantly less than the 10 uncertainty in the external dose."

But with a beta 11 emitter you're not going to have external doses.

So that 12l would imply that you've got to take it into consideration.

13 All I'm saying is we probably need some table.

i 14 guidance.

15, DR. GLENN:

Or at least something a little i

16ilmoreexplicit than just saying that --

i 17 MEMBER SWANSON:

I would actually recommend 1 81 that the NRC make some assumptions that you think are 19 appropriate with regard to these beta emitters and come.up 20 with some calculations for the table because I think in; 21 reality most people are going to release patients based 22 upon your table of guidance anyway.

So please give them i

23 guidance on the beta emitters also.

24 DR. GLENN:

Okay.

25 MEMBER SWANSON:

Don' t leave it open-ended is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.

(202) 234-4433 WASHINGTON. O C. 20006 (202) 234 4 33

549 1

all I'm saying.

1' 2

DR. GLENN:

Okay.

We do have some comments I 3

guess about using ALIs, I guess, if nothing else exists, 4

but --

l 1

5 CHAIRMAN SIEGEL:

Okay.

Can I continue on theI 6,

regulatory guide?

l 7-DR. GLEN:

Sure.

l i

8 CRAIRMAN SIEGEL:

Do you have a copy there, I

9 Stewart, or does someone?

On Page 7 there is a paragraph l 10 that said "The instruction should be specific to the type f i

11, of treatment given, such as" blah blah blah.

"The i

12l instruction should include a contact and phone number in Il 13il case the patient has any questions.

Instructions should ll 14hincludeasappropriate."

u 15l' The rule actually leaves the instructions pretty open-ended.

The regulatory guide is sounding kind I 16ef i.

17 of regulation-like in terms of what the instructions 18' ideally have in them.

It's sounding a little bit i

19l forceful, and I'm wondering whether there's any way to 20l soften it.

21 There's no real rule that says you have to 22 give a contact and phone number.

So if you really think 23 that's essential you maybe need to add that to the rule.

24 And it can be ignored.

25 Are you following me?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. O C. 20005 (202) 234 4433

550 1

DR. GLENN:

Yes.

f' 2

CHAIRMAN SIEGEL:

Maybe I'm overstating my 3

case.

4 DR. GLENN:

Well, I guess I don't know whether' l

5 my copy is different than your copy here.

6 CHAIRMAN SIEGEL:

This is a copy of the May 7

2nd version that Stewart said was --

8 DR. GLENN:

Oh, I've got the May 5th version.

9 CHAIRMAN SIEGEL:

Okay.

So you're ahead of 10j me.

11 MEMBER SWANSON:

Good.

Maybe it's been taken !

i 12f out.

13 DR. GLENN:

Okay.

Yes.

It's on Page 8.

14[Okay.

15h CHAIRMAN SIEGEL:.The "should" sort of comes 16i across like it's part of the rule language.

17l DR. GLENN:

In our lingo, "should" is weak, i

18 but you're saying we_should take note of,the fact that 19[

CHAIRMAN SIEGEL:

Well, I don't feel strongly.

l 20 I think those are reasonable things.

21l DR. GLENN:

Yes.

22 CHAIRMAN SIEGEL:

I'm just wondering if it 23 will be interpreted as a requirement when it's inspected.

24 On what was Page 16 of the regulatory guide, 25

.you're talking about this example of the patient with NEAL R. GROSS COURT REPORTERS AND TAANSCRIBERS 1323 AHOOE ISLAND AVENUE. N W.

1202) 234 4 33 WASHINGTON. O C 20006 I202) 234 4 33-J

551 1

thyroid cancer, and it says "In the example given above, 2

the thyroidal fraction F is 0.05, is a conservative f

I 3

assumption.

For those individuals who have had surgery to d(%

4 remove thyroidal tissue, F is typically smaller."

jsjfj 2

5 In fact, if the thyroid hadn't been removed, F, hi-6 would be considerably higher.

A.05 value assumes that h/

7 the patient has had essentially a total thyroidectomy.

8 And this is the little bit of thyroid tissue that surgeons 9

invariably leave behind that in the course of two weeks 10 has hypertrophied and been stimulated by high endogenous 1

11 TSH levels.

So this is, in fact, not a medically correct l l

12 statement.

I 13 ; '

DR. GLENN:

Okay.

l 14 MEMBER SWANSON:

What page?

15j' CHAIRMAN SIEGEL:

Page 16.

The other example j I

16ll that I found bothersome also on Page 16 was the I

17 hyperthyroidism example, in which you gave 33 millicuries f

!l 18h, of I-131, so the maximum amount, but you did it to a 19 patient who had a thyroid uptake of 55 percent.

That is I

f 20 really blasting a patient for hyperthyroidism.

You just 21i wouldn't do it.

I mean, it is conceivable that a patient I

l 22!

with a multinodular goiter you might treat, but a typical 23 patient with Grave's disease would not get 33 millicuries 24 of I-131.

25 In order to do that, how big would the thyroid NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W (202) 234 4 33 W ASHINGTON. D C 2'J005 (202) 234 4 33

552 1

have to.be?.It would be a monster thyroid gland.

Soit'sf 2

not l

3 DR. GLENN:

It's not wrong, but it's a 4

ridiculous example.

5l CHAIRMAN SIEGEL:

No, it's not even 6

ridiculous.

It's an extreme example.

7 DR. GLENN:

Okay.

8 CHAIRMAN SIEGEL:

So you might want to come, 9

maybe with Myron's help, a little bit closer to the --

10 DR. GLENN:

Get some real ---

11 CHAIRMAN SIEGEL:

I mean, an average patient 12 you could imagine this 55 percent uptake with, let's say 1 31

-- an average case about an 80-gram would be big,'but I

.i 14!

let's say 80-gram thyroid gland with an intended dose of I

15ij 120 microcuries per gram.

That's about where you would be i'

16l on average.

And that's going to come out more like 10 to 17 12 millicuries.

18 I'll do the calculation if you want me to, but 19 that's off the top of my head.

20l DR. GLENN:

I guess the thing --

t 21l MEMBER NELP:

As I understand the instruction, 22 there's no case of hyperthyroidism that would require any i

23 consideration for not releasing them immediately.

24 DR. GLENN:

If it's less than 33 millicuries, 25 there is no reason for doing a calculation.

NEAL R. GROSS COURY REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.

(202) 234 4 33 WASHINGTON. O C. 20005 (202) 234 4 33

553-1 CHAIRMAN SIEGEL:

But I think in order for the1 l

l 2

regulatory guide to be credible, people need to be able to 3

relate it to what they actually do for a living.

And

]

l 4

people are going to look at this and --

5 DR. GLENN:

Yes.

I agree with that.

l 6

CHAIRMAN SIEGEL:

-- say "This is not my j

7 patient."

I i

8 MEMBER NELP:

But the point is below 33 9

millicuries, it's a non-issue.

(

10 DR. GLENN:

Yes.

The table assumes physical l

{

11 decay and 100 percent uptake.

So it's very conservative.

l 12 l

CHAIRMAN SIEGEL:

Okay.

That's all.

Those

13l, are the comments I have.

I i

14; MEMBER NELP:

Now, I could treat with 50 i

d u

15ll millicuries.

j l'

16l CHAIRMAN SIEGEL:

You got it, man.

Sure.

l i

i 17 DR. GLENN:

Okay.

The pregnancy and 18 breast-feeding rule I hope will go very quickly because 19l the status is that it's on hold pending two things.

One, l

20 we have some contracts with BNL and PNL.

In particular, 21 we're trying to get a fix on the placental transfer.

l 22 Pertechnetate turns out to be the problem.

That's the one 23 we're working on.

24 CHAIRMAN SIEGEL:

Right.

25 DR. GLENN:

We won't have that report until NEAL R. GROSS COURT HEPORTERS AND TRANSCRIBERS 1323 RMODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON. O C 20005 (202) 2344433 l

554; 1

fall.

So that's one reason why it's on hold.

2 The other one is that we might as well wait 3

for the National Academy study if we've waited that long. l l

4 CHAIRMAN SIEGEL:

Isn't the breast-feeding 5

rule, a component of that rule, essentially a done deal 6

now?

7 DR. GLENN:

Yes.

It's really the embryo fetus i

'i l

8ll at that point.

l l

9!

CHAIRMAN SIEGEL:

Because, really, the issue

}

10j was all that was in the breast-feeding thing was identify I

f that the patient's at risk and provide instructions.

And li 121, now you've added, really, something that wasn't in the 1

13 original breast-feeding rule:

It can't go over 500 l

14[ millirem.

15 DR. GLENN:

Right.

There are some unresolved 16j issues that we might be up in a final rulemaking.

We 17 don't have a definition for a misadministration under I.

18ij those circumstances.

Should we have a definition for a 1 91 misadministration?

That will wait until after the 20' National Academy has given us some advice.

21l CHAIRMAN SIEGEL:

All right.

t 22 DR. GLENN:

Okay.

In terms of the status of

-23 the contracts, BNL we expect to be completing fairly soon.

24 one thing that I would like to get some input from you, 25 one thing we are considering, the BNL study included NEAL R. GFK33S COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVENUE. N W.

1202) 214 4 33 WASHINGTON. O C 20006 (202) 234 4 33

555 literature searches and going out and visiting eight 1

i 2

licensees and finding out what standard programs were.

3 But when it comes to the kind of cost-benefit 4

study that I think we're going to be asked to do in the l

51 future, we still don't have a good sense of how many of 6

our licensees already have voluntary programs that include 71 either asking or assessing information in terms of 8

pregnancy status.

9 We don't have a good sense of what people are 10 actually doing and how many exposures have taken place.

11 So we don't have a sense of both the cost and the benefit I 12 of this rule.

i 13, And one thing we're thinking about is perhaps I

i 14i it's worth it to go out with a mail survey, either throughj i:

I 15] BNL or one of the professional societies, and actually i

I 16]gettingthat information if we're going to proceed with 17 the rule.

18 CHAIRMAN SIEGEL:

Sure.

Let me ask another 19 question.

Your time frame for gathering that data is 20 what?

21 DR. GLENN:

We wouldn't be going for a final 4

22, rule until next year.

And so we could start the survey 23 this fall.

24 CHAIRMAN SIEGEL:

Now, that's fairly i

25 complicated, involves OMB approval and all that?

NEAL R. GROSS COURT REPOR1ERS AND TAANSCRIBERS 1323 AMODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON O C 20005 202) 234 4433

556 1

DR. GLENN:

Right.

I l

2 CHAIRMAN SIEGEL:

Why not just start today and 3

tell your inspectors to start asking 30 seconds worth of 4

questions about what people do with pregnancy and Sj breast-feeding and record it and send it back to 6

headquarters?

You're not inspecting them.

7 DR. GLENN:

No.

I 8l CHAIRMAN SIEGEL:

You just want to know.

And 9

maybe it won't be a random sample either, but neither will 10ll

, a mail survey.

if 1 14 MR. CAMPER:

That's possible.

We would want t

i 12l to alert the community through some informational process 13 that we're doing that and why because I'm sure there will r

14 be some complaints otherwise.

15j DR. GLENN:

Now, we will have the BNL study.

j 16o We'll have the literature search and all of that in June.

17! And that's probably the time to make that decision.

But 18 we have been considering a wider survey in order to get 19 better data.

20:

The PNL study, which is the placental transfer 21 and we would have ORISE being the peer review group for 1

2 21 that, we expect that in December of 1995.

23 CHAIRMAN SIEGEL:

Okay.

24 DR. GLENN:

Any questions on that?

25 CHAIRMAN SIEGEL:

No.

NEAL R. GROSS COURT REPORTERS AND TRANSCAIBERS 1323 RHODE ISLAND AVENUE. N W.

(202) 234 4433 WASHINGTON. O C 20005 (202) 7344433 L

l 557-1 DR. GLENN:

Thank you.

2 CHAIRMAN SIEGEL:

I love it.

Well, it 3

certainly would be useful to get the tables, but maybe if 4

you want to polish them any further before you send them 5

to us.

Otherwise the rest of the slides I don't think we 6

need.

They'll be in the transcript anyway, won't they?

I 7

You've not been adding slides to transcripts?

Okay.

'8 Fine.

Good.

9 John, thank you.

10 All right.

We have some administrative 11 matters.

I 12 MR. CAMPER:

Yes, we have a few things to 13 bring to your attention.

i i

14 In your briefing books, we have provided some 15 information on travel issues.

From time to time some of 16 you have had some difficulties in getting your travel 17 vouchers and so forth processed in a timely manner.

And 18 there is some information there for you to review.

I 19 The main thing is the idea of filling out the 20 forms completely and preferably in a timely manner so that 21 we can respond to them as promptly as possible.

And if 22 you'll look through the information there, we'll provide 1

23 you with some instructions to hopefully help you in doing 24 that.

25 We would like to wrap up your travel and your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 AHODE ISLAND AVENUE, N W i

(202) 234 4 33 WASHINGTON. O C 20006 (202) 234 4 33

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\\.h.W...!. A Nuclear Regulatory Commission INSTRUCTIONS FOR BREAST-FEEDING WOMEN Dose to Infant If No Interruption Recommendation on Radio-Administered of Breast Instructions Interruption of j

pharmaceutical Activity' Feeding' Required?'

Breast Feeding

• I (mci (MBq))

(mrem) 1-131 Nal 150 (5550) 60,000-yes Complete cessation 40,000,000 is necessary to avoid thyroid I

ablation in the infant I-123 Nal 0.4 (14.8) 60 no None I-123 OIH 2 (74) 4-30 no None I-123 mIBG 10 (370) 300 yes Interruption for about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> I-125 OIH 0.01 (0.37) 0.2 no None I-131 OIH 0.3 (11.1) 3-20 no None Tc-99m DTPA 20 (740) 0.3-6 no None Tc-99m MAA 4 (148) 4-300 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m 30 (1110) 200-800 yes Interruption for pertechnetate about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Tc-99m DISIDA 8 (300) 4-20 no None Tc-99m 20 (740) 2-5 no None glucoheptonate Tc-99m HAM 8 (300) 20-50 no None Tc-99m MIBI 30 (1110) 1-10 no None Tc-99m MDP 20 (740) 4-5 no None Tc-99m PYP 20 (740) 5-20 no None Tc-99m RBC's in 20 (740) 0.3-100 yes Interruption for vivo labeling about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> ACAIUI Alreting 9

Afay 12,1995

p\\

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United States

%,,,,,/

Nuclear Regulatory Commission j

INSTRUCTIONS FOR BREAST-FEEDING WOMEN (CONTINUED)

Dose to Infant If No Radio-Interruption Recommendation on pharmaceutical Administered of Breast Instructions Interruption of Activity' Feeding' Required?'

Breast Feeding *

(mci (MBq))

(mrem)

Tc-99m RBC's in 20 (740) 1-2 no None vitro labeling Tc-99m sulfur 12 (444) 9-100 yes Interruption for colloid about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m DTPA 1 (37) 0.02-0.5 no None aerosol Tc-99m MAG 3 10 (370) 0.2-2 no None Tc-99m WBC's 5 (185) yes Interruption for about 247 hours0.00286 days <br />0.0686 hours <br />4.083995e-4 weeks <br />9.39835e-5 months <br /> Ga-67 citrate 5 (185) 300-10,000 yes Complete cessation Cr-51 EDTA 0.05 (1.85)

< 0.01 no None In-lll WBC's 0.5 (18.5)20-100 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> T1-201 3 (111)

Maximum activity normally administered.

1. Doses are calculated for the maximum administered activities shown in Column 2. If a smaller activity were administered, the doses would be proportionally smaller. The doses are calculated for newborns; doses to a one-year-old would be less than half the doses shown. If a dose range is shown, the range is due to individual variability and measurement variability as indicated by different measurements of concentrations in breast milk.

The doses include internal doses only; external doses due to close contact during nursing were found to be small relative to the maximum of the internal dose range. The details of the calculations are shown in NUREG-1492.

" Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material."

'The decision on whether instructions are required by 5 35.75(b) is based on the maximum value of the dose range for the newborn exceeding 0.1 rem.

'The duration of interruption is selected to reduce the maximum dose to a newborn infant to less than 0.1 rem.

The actual doses that would be received by most infants would be far below 0.1 rem. The physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat depending on the mother's concerns about radioactivity or interruption of breast feeding.

ACAft! Alerting 10 Alay 12,1995

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UNITED STATES f

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t WASHINGTON, D.C. 20m1 o

• • • • • f May 31, 1995 MEMORANDUM T0:

Carl J. Paperiello, Director Office of Nuclear Material Safety & Safeguards Richard L. Bangart, Director Office of State Programs Martin G. Malsch, Deputy General Counsel Office of the General Counsel Walter E. Oliu, Acting Chief Rules Review and Directives Branch Office of Administration Gerald F. Cranford, Director Office of Information Resources Management James Lieberman, Director Office of Enforcement j

/ '$ 4 FROM:

David L. Morrison, Director b'4/f. ' N' ' d'

~

Office of Nuclear Regulatory Research

SUBJECT:

0FFICE REVIEW AND CONCURRENCE:

DRAFT FINAL RULE - CRITERIA l

FOR THE RELEASE OF INDIVIDUALS ' H NISTERED RADI0 ACTIVE MATERIALS Your assistance is requested in reviewing the attached rulemaking package and providing me with your comments and concurrence.

The following is a summary of this request.

1.

Title:

Final Rule on Criteria for the Release of Individuals Administered Radioactive Materials 2.

RES Task leaders:

Stewart Schneider, 415-6225, and Stephen A. McGuire, 415-6204 3.

Coanizant Individuals:

NMSS - Patricia Holahan, Cathy Haney OGC - Bradley Jones SP

- Lloyd Bolling 4.

Reauested Action:

Review, comment, and provide concurrence.

5.

Reauested Completion Date: June 7, 1995.

i 4-7b 8 f56/ k ~ 3 g.

,,---a s

C. J. Paperiello, et al.,

6.

Background:

A working group was formed to develop the draft final rule.

The members of the working group are:

Stephen McGuire, Stewart Schneider, Sam Jones, Cathy Haney, Patricia Holahan, and Bradley Jones.

Note that the associated Regulatory Guide will be sent to the Commission as a working draft for their information, not their approval.

Do not comment on the guide at this time. The guide will be sent for Office concurrence review at a later date.

No additional resources are anticipated to implement the rule. A copy of this concurrence package has been forwarded to the Office of the Controller for coordination of resource issues per the EDO memorandum of June 14, 1991.

Attachment:

Rulemaking Package j

cc w/atts.:

R. M. Scroggins, OC D. C. Williams, IG W. Beecher, PA D. K. Rathbun, CA

g 7

19E 4l-3

.s-to C. J. Paperiello, et al. 6.

Backaround: A working group was formed to develop ' he draft final rule.

t The members of the working group are: Stephen McGuire, Stewart Schneider, Sam Jones, Cathy Haney, Patricia Holahan, and Bradley Jones.

Note that the associated Regulatory Guide will be sent to the Commission as a working draft for their information, not their approval. Do not corrent..en the guide at this time.---The guide. will be sent for Office concurrence review at a later date.

No additional resources are anticipated to implement the rule. A copy of this concurrence package has been forwarded to the Office af the Controller for coordination of resource issues per the EDO memorandum cf-June 14, 1991.

Attachment:

Rulemaking Package cc w/atts.:

R. M. Scroggins, OC D. C. Williams, IG W. Beecher, PA D. K. Rathbun, CA 4

DISTRIBUTION:

JEGlenn, RPHEB R/F PHolahan, NMSS RES Files CHaney, NMSS LRiani BJones, 0GC-SJones LBolling, SP iSSc. h,aeW.M

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DOCUMENT NAME:

g:\\mcguire\\ release \\offconc.let

• See previous concurrences Y

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a::::::,:.:t:e:.-:: :r::;,--- - -

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- ~> -"-

0FFICE:

DRA/RPHEB*

DRA/RPHEB*

DRA/RPHEB*

,D/QBA NAME:

SSchneider;ss SMcGuire JGlenn' M ris l

DATE:

5/17/95 5/17/95 5/25/95 5/3//95 N

0FFICE:

D/RES NAME:

DMorrison4 g g%rru DATE:

Shf/95

/.

OFFICIAL RECORD COPY

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, ft UNITED STATES j

j NUCLEAR REGULATORY COMMISSION

't WASHINGTON, D.C, 20555 4001

\\,*..../

June 5, 1995 MEMORANDUM T0: David L. Morrison, Director Office of Nuclear Reg latory Research

-W d*:!.E FROM:

A David L. Meyer, Ch ef Rules Review and Directives Branch I

Division of Freedom of Information and Publications Services Office of Administration

SUBJECT:

0FFICE CONCURRENCE ON A FINAL RULE PACKAGE REGARDING REGARDING CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIAL The Office of Administration concurs, subject to the comments provided, on the final rule package regarding the criteria for the release of individuals administered radioactive material. We have attached a marked copy of the package that presents additional editorial comments.

The Statement of Considerations for the final rule must contain a clear statement that indicates the final disposition of the petitions for rulemaking that the rule addresses (PRMs 20-20, 35-10 and 10A, and 35-11).

If the statement in the proposed rule remains valid, the final rule should indicate da,,

that these petitions are partially granted, specify the aspects of the

~

petitions that have been granted, indicate that the remaining portions of the petitions are denied, and state that the final rule completes action on the petitions.

We have adjusted the amendatory instruction for the authority citation to Part 3 20 and provided the currently effective text of that authority citation.

UO When these documents are forwarded for signature and publication, please have a member of your staff include a 3.5-inch diskette that contains a copy of the s>;tt.,

The n 3,.

document in Wordperfect 5.0 or 5.1 as part of the transmittal packages.

diskettes will be forwarded to the Office of the Federal Register and the o.(_,,,

C Government Printing Office for their use in typesetting the documents.

%, u m W%

Please note that the information collection requirements contained in the final rule must be approved by the Office of Management and Budget before the final rule may be submitted for signature and publication.

Please contact the Information and Records Management Branch, Office of Information Resources Management, concerning the paperwork management aspects of this rulemaking action.

I

.T2Dk'CeW &f.

O

. David L.lMorrison '

i I

To assist you in preparing the list of documents centrally relevant to the final rule that is required by NRC's regulatory history procedures, you should place the designator "AE41" in the upper right-hand cdrner of each document concerning the rule that you forward to the Nuclear Documents System.

If you have any questions concerning this matter, please have a member of your staff contact Michael T. Lesar, 415-7163, Rules Review Section, Division of Freedom of Information and Publications Services.

Attachment:

As stated 1

s i

1 l

I pc als From: Beth'C. St. Mary (BCS)

To:

SAM 2 Date: Wednesday, June 7,1995 4:03 pm

Subject:

RULE CONCURRENCE

Steve, IRM concurs in the final rulemaking, " Criteria for the Release of Individuals Administered Radioactive Material," subject to the following changes.

Change the PRAS to the enclosure. The burden reflected in the PRAS also appears to g

need revision as it currently reflects the burden for the proposed rule and has changed.

Change section 35.8 to the enclosure. Since the time the proposed rule was published, a A,.

final rule has become effective that changes the sections containing information g

collections.

I have not yet reviewed the OMB clearance package, but I will send you comments as soon the review is complete. If you have any questions, please e mail me at BCS or phone me at 415-5878.

CC:

BJS1 Files: P:\\PRAS, P:\\OMBPT35 i

j l

\\

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. h; UNITED STATES

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g NUCLEAR REGULATORY COMMISSION j

j WASHINGTON. D.C. 20555 0001

'%,]';'"

June 8, 1995 MEMORANDUM T0:

Michael T. Lesar, Chief Rules Review Section Rules Review and Directives Branch Division of Freedom of Information and Publications Services Off' e of Administr in FROM:

f Infr%a ati and Records Management Branch Office of Information Resources Management

SUBJECT:

REQUEST FOR COMMENT AND CONCURRENCE ON THE FINAL RULE, 10 CFR 35.

CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIALS l

In response to your subject memorandum, the Information and Records Management Branch (IRMB) provides the following:

The Paperwork Reduction Act Statement (PRAS) is correct.

X Change the PRAS to Attachment 1.

k The "Information Collection Requirements: 0MB Approval" section is correct.

O g ng Approval" section to X

Change the "Information Collection Requirements:.

X Do not publish the " Federal Register Notice" until further notice.

The " Federal Register Notice" can be published.

Enclosed is a copy of the IRMB memorandum to the program office addressing our concerns.

A copy of the IRMB memorandum to the program office addressing our concerns will be forwarded at a later date.

X An IRHB memorandum to the program office is not required.

Attachments:

As stated cc:

S. McGuire. RES J. Glenn. RES./

m i

PAPERWORK REDUCTION ACT STATEMENT This final rule (or final policy statement) amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget. approval number 3150 0010.

The public reporting burden for this collection of information is estimated to average hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send connents regarding this burden estimate or any other aspect of this collection of information. including suggestions for reducing this burden, to the Information and Records Management Branch (T 6 F33), U.S. Nuclear Regulatory Commission. Washington, DC 20555 0001, and to the Desk Officer, Office of Information and Regulatory Affairs.

NE08 10202 (3150-0010), Office of Management and Budget. Washington, DC 20503.

i

d-

}

$35.8 Information collection requirements: 02 approval (b) The approved information collection requirements contained in this part appear in $$ 35.12. 35.13, 35.14, 35.21. 35.22. 35.23, 35.29, 35.31, 35.50. 35.51, 35.52 l

35.53, 35.59. 35.60. 35.61. 35.70, 35.75. 35.80. 35.92. 35.204, 35.205. 35.310 35.315, 35.404, 35.406, 35.410, 35.415, 35.606. 35.610. 35.615, 35.630. 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980. and 35.981.

I i

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UNITED STATES 7

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W ASHINGTON, D.C 2055mt Schnei.

Fila

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June 9 1995 MEMORANDUM T0:

David L. Morrison, Director Office of Nuclear Regulatory Research FRON:

James Lieberman, Director g{

Office of Enforcement

SUBJECT:

OFFICE REVIEW AND CONCURRENCE ON A FINAL RULE - CRITERIA FOR l

THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIALS The Office of Enforcement has no objection to the subject draft final rule. Attached are three pages with miscellaneous edits that you may wish to consider.

Enclosure:

As stated 4

9 i

l S M/6'et92. jf,

b en neco g

p s

E UNITED STATES E

NUCLEAR REGULATORY COMMISSION cc: Morris i

4,,S., [,,, + f WASHINGTON, D.C. 20555 mot GIenn June 12, 1995 Schneider i

McGuire j

file dm MEMORANDUM T0:

. David L. Morrison, Director Office of Nuclear Regulatory Research FROM:

xicri'afo L. Bangart, Director

~

Office of State Programs Il

{

A[

SUBJECT:

0FFICE REVIEW AND CONCURRENCE:

FOR THE RELEASE OF INDIVIDUALS ADMINIS i

MATERIALS This is in response to your May 31, 1995 memorandum on the subject document

\\

We have reviewed the draft final rule as it applies to the Agreement States through compatibility requirements.

staff and Stewart Schneider, RES on Wednesday June 7, 1995, the j in 10 CFR Part 20.1002 Agreement States.

was revised to a Division III item of compatibility for dated May 3, 1995), we concur in the rule. Based on this revision a

Attachment:

As stated i

t q 90VWL4W /f'

k gewn From: Shelly L. Shortt (SLS)

To:

SAM 2, SXS4 Date: Thursday, June 8,1995 11:21 am

Subject:

FINAL AMEND TO 10 CFR PARTS 20 AND 35 Stewart Schneider, RES Stephen McGuire, RES As requested by DMorrison's memorandum of May 31,1995, OC 'has reviewed the Draft Final Rule on the Criteria for the Release of Individuals Administered Radioactive Materials.

By this e-mail I am providing you with office concurrence.

Please contact me on 415-6032 if you have any questions.

Thanks.

Shelly Shortt CC:

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[w ft I,1NITED STA ES h 6(([- }

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NUCLEAR REGULATORY COMMISSION C

WASHINGTON, D.C. 20555-0001 8

June 13, 1995

%.....p MEMORANDUM T0:

David L. Morrison, Director Office of Huclear Regulatory Research

}

FROM:

Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards

SUBJECT:

OFFICE REVIEW AND CONCURRENCE: DRAFT FINAL RULE - CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIALS This Office has reviewed the rulemaking package for " Final Amendments to 10 CFR Parts 20 and 35 on Criteria for the Release of Individuals Administered Radioactive Material" and we concur. As you requested in your memorandum dated May 31, 1995, we are not providing comments or concurrence on the draft Regulatory Guide at this time.

i i

Contact:

Patricia K. Holahan, NMSS (301) 415-7847

-nus m a i.

P

ts.* Mcg UNITED STATES fj g'o,,

NUCLEAR REGULATOP.Y COMMISSION

-p p

., WASHINGTON, D C. a s555-0001 5

e o,

June 15',

1995 OFFICE OF THE GENERAL CoVNsEL MEMORAND'JM T0:

David L. Morrison, Director Office of Nuclear Regulatory Research p

FROM:

Stuart A. Treby

[

I Associate General Counsel for Rulemaking and Fuel Cycle

SUBJECT:

DRAFT FINAL RULE - PATIENT RELEASE CRITERIA We have reviewed the final version of the draft final rule addressing release of individuals administered radioactive materials. The revisions have satisfactorily addressed our earlier comments and we have no legal objection to this'rulemaking package.

CONTACT:

Bradley W. Jones, 0GC 415-1628 l

MOVISn/gg I.f