ML20134N489

Transcript of Advisory Committee on Medical Uses of Isotopes Meeting on 961114-15.Pp 14-327 & 328-527.W/supporting Documentation

ML20134N489
Person / Time
Issue date:	11/14/1996
From:	NRC
To:
Shared Package
ML20134N493	List: ML20134N489 ML20134P540
References
NACMUI, NUDOCS 9611270003
Download: ML20134N489 (654)

Text

. _ _ . _ . .- . _ _ _ . . _ _ ._._. _ _._ _

Official Transcript of Proceedings i O NUCLEAR REGULATORY COMMISSION l

Title:

Advisory Committee on the Medical Uses of Isotopes j '

Docket Number: (not applicable)

I i Location: Rockville, Maryland i J I

iO Thursday, November 14,1996

\

lV Date:

l NRC-910 Pages14-327 Work Order No.:

NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 O'

(202) 234-4433 m= = PDR

.)

l O DISCLAIMER

'This is an unofficial transcript of a meeting of the Advisory Committee  ;

of the Medical Uses of Isotopes, of the United States Nuclear Regulatory i

Commission. held on November 14-15, 1996, at the U.S. Nuclear Regulatory '

Commission. Two White Flint North. Washington. D.C. 20555. All but one i session was open to the public. One session of the' meeting was closed to the l public to prevent invasion of personal privacy of committee members.

This transcript has not been reviewed, corrected or. edited, and it may contain inaccuracies. I The transcript is intended solely for general informational purposes. i As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this j transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to any statement or argument contained herein. l l

except as the Comission may authorize.

4 l

O u

r

/"N MEMBERS OF THE PUBLIC SIGN IN SHEET (D0 NOT REMOVE THIS FORM) l 4

ACMUI Meeting November 14-15. 1996 U.S. Nuclear Regulatory Commission -

Two White Flint North. T283  ;

j Please print legibly, as this is a public document NAME NAME h ece c O. 3ones h v; b d ;) _

l s c6 w . & a.s s  %$4gd.s4-Jam i ilt;ss M - ' hva hs,i ( Q! On h l N //f Et b Y f lo iu b u , _ . - . , ac h w A Ah k ts

! h-pt TL pi%

J ObO/sm 1 a 6 h2L f A P pt? 16 L t.- c? G i:' n a r F u z i c t h L , ,.O  !%i d t' 'tu J ,

'cEdavT ,gyth g St, p C i o nn1  !

0:/ vbM5cn Eku n e n%; cm i /O '

s Au t m L rw is ,

b[

- m i i

,, s- -

(- fk f 4 A b (v 1

O d

I

,rs, MEMBERS OF THE PUBLIC SIGN IN SHEET

( ,) (D0 NOT REMOVE THIS FORM)

ACMUI Meeting l November 14-15, 1996 U.S. Nuclear Regulatory Commission Two White Flint North, T2B3  ;

Please print legibly, as this is a public document NAME NAME l

)

od ft ') i b, \% s c, \. e mgd I l\ V;9 ( L-a .

• , \O N ( ,k$  %

S-6

\ . (8 L [L e \

l

/ S' t '

/ ,I- Gv ,h . c.

, .d ., 3

~- f

s. g 's K, ,. g (' k *g ,g

~

a w_33.M:mem l > , -, a J4 se

('S

'\ ..J ,,'

s'

• I j /.'ss .

'l 2 h: b'l i \, g w s' s t h*

e *t 'd , Y _c_

e l

1 I k( k

's )

n.

d ,# 4 k* . _l eg 4 4  %

s .

- /

e" 7 7 * . g. -7,"* , ,

• A )

A

.%< Zn a n a s.>u (m ') ., p.e. wo>J-

. .,...s. . .

c. ~ . . . .a:p s

-l -

. ADVISORY COMMITTEE ON r.EACTOR SAFEGUARDS '

b FULL COMMITTEE MEETING m

( Ih u. % i

/ 99,4 i NRC STAFF SIGN IN FOR ACRS MEETING PLEASE PRINT NAME BADGE NO. NRC ORGANIZATION 4-Mek b']l0 Y m e s .S e n IAw SfsPP d k6 d b ""

i ) n 1

4

., *Y t

1

[ ~~

(

i

(

PLEASE PRINT

. .q,5 g *, N h ; , ' r f :, Y r b -

.  :' Y '

!' A ' '

14 1

UNITED STATES OF AMERICA es \ 2 NUCLEAR REGULATORY COMMISSION ik

' \

/

3 +++++

, 4 ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) 5 +++++

6 OPEN SESSION 7 +++++ i i

8 THURSDAY, NOVEMBER 14, 1996

. 9 +++++ l l 10 ROCKVILLE, MARYLAND 1 11 The Advisory Committee met at the Nuclear

. 12 Regulatory Commission, Two White Flint North, Room T2B3, t

13 11545 Rockville Pike, at 9:00.a.m., Judith Anne stitt,

'\v) 14 Cha.i; man, presiding.

15 COMMITTEE MEMBERS:

16 JUDITH ANNE STITT, M'.D. Chairman

17 JUDITH I. BROWN Member 4

18 DANIEL F. FLYNN, M.D. Member 19 JOHN GRAHAM Member 1

20 ANDREW KANG, M.D. Member 21 *WIL B. NELP, M.D. Member i i

22 DENNIS P. SWANSON, M.S., B.C.N.P. Member

! 23 LOUIS K. WAGNER, M.D. Member 24 THERESA WALKUP, C.M.D. Member

. s

y)\

i 25 JEFFREY F. WILLIAMSON Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2N WASHINGTON, D.C. 2000H701 (202) 2M

\

15 1 INVITED GUESTS:

2 Naomi Alazraki, M.D.

l l 1 3 Jill Lipoti j

\ 4 l l

5 ACMUI STAFF:

6 Torre Taylor 7

8 ALSO PRESENT:

1 9 John Szabo 10 Donald A. Cool 11 Carl Paperiello '

12 Bob Ayres 13 Patricia Holahan I

14 George Pangburn 15 Larry W. Camper 16 Sally Merchant 17 18 19 20 21 l

22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON. D.C. 20005 3701 (202) 2W

..-- ~ - . - . - - - - - - . . . . . . . . . . . - . ~ . . - . - . . - . - - . - . . - . . . _ ~ . .

1

l. 16 i 'l I-N-D-E-X f.- 2 Acenda Item Eggg

!G 3 Director's Comments, Carl Paperiello 23 l -i 4 Status Reports and Discussion

[

5 e Advance Notice of Proposed Rulemaking for 50 i

j 6- Part 33, " Specific Domestic. Licenses of 1

7 Broad Scope for Byproduct Material,"

l 8 Patricia Holahan i 9 Strategic Assessment and Discussion of Direction i

] 10 0 Setting Issues Papers, Larry Camper 54 i 11 (Resumed) 224 l- ,

[ 12 Discussion of Mobile HDR, Bob Ayres 175  !

13 Status Reports and Discussion i 14 e Memorandum of Understanding with the U.S.

i  ;

3 15 Food and Drug Administration, Larry Camper 289 3

16 e Modules for Regulatory Guide, 10.8, " Guide i

! 17 for the Preparation of Applications for 1 <

.18 Medical Use Programs," Sally Merchant 294 l

1 i

). 19 e continuing Implementation of the Quality 20 Management Rule, Sally Merchant 302 s

j.. 21

! 22 i

} 23

}

,! 24 Q 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

, -. . - a

17 1 P-R-O-C-E-E-D-I-N-G-S 2

(9:04 a.m.)

V 3 MR. CAMPER: Good morning. We probably should 1

4 get started. Given that we always have more time or more 5 issues to discuss than we have time and given that I'm i

6' supposed to try to keep us on track, I think we'll get 7 started. I know there are a lot of " Hellos" and new 8 faces. We'll have time for that, but why don't we get 9 started?

10 Good morning, ladies and gentlemen. I am  !

i 1

11 pleased to welcome you to the NRC headquarters here in 12 Rockville for this public meeting of our Advisory 13 Committee on the Medical Uses of Isotopes.

14 I am Larry Camper. I am the Chief of the 15 Medical Academic and Commercial Use Safety Branch, and I 16 am the designated federal official for this Advisory 17 Committee meeting.

18 This meeting is an announced meeting of the 19 Advisory Committee, and it is being held in accordance 20 with the rules and regulations of the Federal Advisory 21 Committee Act and the Nuclear Regulatory Commission.

22 This r ating was announced in the Federal 23 Register on Octobit the 21st, 1996. The notice stated the 24 meeting would begin at 9:00 a.m. And we're about three 25 minutes late. So we're very close.

NEAL R. GROSS court REPORTERS AND TRANSCRSERS 1323 RHoDE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

l l 18 i

l 1 The function of ths Advicory Committ aa in to 2 advise the NRC staff on issues and questions that arise on 3 the medical use of byproduct material. The Committee 4 provides counsel to the staff but does not determine or 5 direct the actual decisions of the staff or the 6 Commission. The NRC solicits the opinions of the counsel, 7 and the counsel values the opinions of this Committee very 8 much.

9 The staff requests that the Committee, 10 whenever possible, reach a consensus on the various issues 11 that will be discussed today and tomorrow or in any 12 Committee meetings, for that matter, but also if there are 13 dissenting or differing opinions, that those be stated and 14 clearly articulated. I ask that, if you could, please is confine your comments to the issue being discussed at the 16 time because we have much to cover.

17 As part of the preparation for this meeting, I 18 have reviewed the agenda for members and your various 1

19 employment interests. I have not identified any conflicts 20 based upon the very general nature of the discussion that 21 we'll be having over the next day and a half. Therefore, 22 I see no need for any individual member of the Committee 23 to recuse themselves from our discussion. However, if 24 during the course of our business you determine that you 25 may have some conflict, please state that for the record NEAL R. GROSS COURT REPORTERS AND TRANSCRISE.RS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433

19 1

and recuno yournalf from that particular anpset of e- 2 discussion.

\~ / 3 We have an interesting situation this time in 4 that we have a couple of invited guests, which I will 5 introduce as I go around the table. And, as an 6- administrative item, it's important to point out that our 7 invited guests will be able to actively participate in the 8

discussions that the Committee will have on the various 9 topics. l j

10 However, at those points in time when actual i 11 consensus building is taking place in that, for example,  !

12 the chairman may state what she believes to be the view of 13 the Committee that she has heard, and this becomes a Ch

(_ / 14 matter of record, if there is a vote or a clear effort at is consensus building, I would ask our guests not to 16 participate in that vote.

17 one of our guests will b3 becoming a full 18 member of the Committee, and I'll cover that in just a 19 moment when I go around the table. Of course, at that 20 point in time that person would be able to participate in 21 the actual voting and consensus building.

22 With that, then, let me go around the table 23 for the record and make some introductions. At the far 24 end of the table we have Dr. Jeffrey Williamson. Dr.

25 Williamson is a medical physicist. And he is representing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE' ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 244 4433

20 1

the technical expertice of r:diation tharapy.

2 Next to Jeffrey we have Theresa Walkup.

3 Theresa is a certified medical dosimetrist. And she is 4

fulfilling the position for radiation technologist or 5 dosimetry.

6 Next we have Dr. Lou Wagner. Dr. Wagner is 7 representing medical physics, specializing in nuclear 8 medicine physics.

9 Next to him is Mr. Dennis Swanson. Dennis is 10 a radiopharmacist representing the radiopharmaceutical 11 concerns.

12 Next is Dr. Wii Nelp. Dr. Nelp is a physician 13 representing the research specialty.

14 Then we have Sally Merchant. Sally is a 15 member of my staff. She's currently the acting section 16 leader for the medical sec' tion.

17 And to my immediate left is Dr. Judith Stitt.

~

18 Dr. Stitt is the Chairman of the Committee, the esteemed 19 Chairman of the Committee, I might add. And Dr. Stitt, as 20 all of you probably know, is taking over for Dr. Siegel, 21 who has now moved from the Committee. And we look forward 22 to working with Judith, as we have for Barry, for several 23 years.

24 And to my right we have Dr. Andrew Kang. Dr.

25 Kang is a physician representing the FDA. I think you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

, 21 1

know that the FDA han a slot on the Committee and sends

.2 representatives according to the subject matter at hand.

'3 1 j'O 3 Next is Mr. John Graham.

a Mr. Graham is 4 representing Health Care Management Perspectives.

i 5 Next we have Dr. Daniel Flynn. Dr. Flynn is a 6 radiation therapist.

7 Next we have Judith Brown, a

Judith represents 8 patient rights and health care advocacy positions.

9 Next we have Dr. Naomi Alazraki. Dr. Alazraki 10 is one of our two invited guests. Dr. Alazraki has been 11 approved by the Commission to fill the nuclear medicine 4

5 12 specialty that was vacated by Dr. Barry Siegel. So Dr.

i 13 Alazraki will be joining us as a full member hopefully by

, b 14 the next meeting. It's good to have you here. Welcome.

15 And then, finally, we have Dr. Jill Lipoti.

16 Dr. Lipoti is the Director of the Radiation Protection 17 Program for the State of New Jersey. Dr. Lipoti is our 18 guest today, and we're very happy to have her with us.

19 Bob Quillin, who was our states regulator i

20 representative to the committee, has resigned from the i .

21 Committee. Bob has gone through a significant

, 22 reorganization of his program in Colorado, has assumed a 23 much later degree of responsibility, and felt he could not 24 give the ACMUI the attention and energy that it needed.

()

O 25 And what we wanted to do was to make sure that NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoOE ISLAND AVEL, N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2W

22 1

given como of tho iscuse that wa're diccuccing in this 2

particular meeting, particularly those dealing with the 4 g 3

strategic assessment papers and the potential impact for 4

Part 35, we wanted to make sure that we captured a states 5 regulator's perspective. So Dr. Lipoti is filling in for 6 that role for us.

7 With those introductions, I think I've 8 captured everyone.

We have some members of the NRC staff.

9 Dr. Cool is here. Dr. Paperiello is here.

10 Torre Taylor, whom most of you work with a 11 lot, is the member of the staff who handles a lot of the 12 coordination and administrative functions for the ,

13 Committee. And without here, we couldn't get these things

( I 14 together.

15 Tracy Kime is a member of our staff who is 16 helping us today. And-Tracy will be working with us all 17 through the day. So if you have questions, either of 4 18 those two are available.

19 And then with those introductions, just a 20 couple of administrative items. We have some members of 21 the public with us. We're glad to see that. We always 22 welcome public observation of the meeting, and we hope 23 that you'11 find it very interesting and worthwhile.

24 We do have down the hallway behind me, at the 25 e nd of the hallway, you'll find restrooms: gentlemen to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000 5 3701 (202) 234 4433 1

A 23 1 the left, ladies to the right as you face down the 2 hallway. And then downstairs on the lobby level of the 3 building, there is a full-service cafeteria for coffee and 4 for lunch and so forth and so on.

5 So, with those administrative items and those 6 opening remarks, I would next turn the meeting over to 7 either Dr. Cool or Dr. Paperiello for the director's 8 comments. This is the opportunity for either the office 9 director or the division director to share with you some 10 of their perspectives or concerns or things that may be on i 11 their mind about the business you are going to conduct.

12 So, Dr. Paperiello? Dr. Cool?

13 DR. PAPERIELLO: I can't stay for all that 14 long. So I'll only speak for a few minutes and then turn 15 it over to Don Cool. Obviously since I moved to my 16 current position from the division director I've picked up 17 responsibilities for fuel cycle activities and high and 18 low-level waste and a lot of things that are very 19 well-separated from the area of nuclear medacine. But 20 obviously this is an area I started out in many years ago.

21 So I'm obviously still interested in it. And it does 22 provide an enormous number of events that we have to j 23 respond to.

24 You're going to hear a lot of interesting 25 things today. And there is movement in strategi'c NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701- (202) 234 4433

24 1 accasem:nt, Port 33.

And it will eventually have bearing, 2 I think, on the medical regulations.

)

3 My sense -- and you'll hear later -- from 4

dealing with the individual commissioners on strategic 5 assessment is there is not a strong support for the IOM l

6 report that says that NRC should completely remove itself 7 from nuclear medicine. That's the sense. We're 8

eventually going to get a finding from the Commission, but 9 if you look at the strategic assessment paper in this 10 particular area, it is basically remaining and fixes 11 problems.

12 Part 33, even though it deals with broad 13 scope, will affect a lot of large medical institutions.

14 You're going to hear about that. The goal is and partly a 15 good deal of my goal in many of the changes that I 16 anticipate we will be making in the regulations over the 17 next several years is what the Commission calls 18 risk-informed, performance-based regulation. But 19 basically I want to turn around and set goals and let the 20 how to people achieve goals to the people who do the work.

21 When I did my report on the medical program 22 several years ago, what I noted to the Commission was that 23 if one looks at where the world was 25 years ago and where 24 it is today, there is an enormous growth in 25 infrastructure.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

ll (202) 2h33 WASHINGTON, D.C. 20005 4701 (202) 234-4433

25 1

Wa hava a lot of people out there who know how g-s 2 to do the job right and, in fact, certainly no better than

-/ 3 people here in Washington.

i But we can turn around and set 4 the goals. Essentially we set the speed limit and the 5 people who are doing the work.

6 So, therefore, overlying all of this, the 7

changes that we're trying to make, for example, in Part 33 8

and which eventually I think we will see and changes to 9 Part 35 is a deemphasis on prescriptive ways of getting.to l 10 a certain place.

11 And I've had arguments with attorneys around 4

12 here about whether or not a speed limit is a prescriptive

~s 13 regulation or performance-based. In my mind it's

' '\s-) 14 performance-based. So I don't tell you how often you have 15 to check your speedometer. I don't tell you you have to 16 get it calibrated.

All the state tells me is this is what 17 the speed limit is. If I'm caught exceeding the speed 18 limit, then I pay an appropriate penalty.

19 What I'm looking at is evolving toward a 20 regulatory framework where there are goals that are set 21 out there in the industry, whatever industry it is, the 4

22 people who are doing the work, who have the expertise, and 23 particularly in those areas where there is a tremendous 24 infrastructure. And medicine is one of them.

I

( ,) 25 And, frankly, for academic, broad scope is a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 23N WASHINGTON, D.C. 20006 3701 (202) 23& 4433 a

26 1 cimilcr cituntion. Those people turn around and tell us, 2

either through consensuc standards or something like that,j }

3  !

how to get there.

So that's a kind of direction I see us 4 heading in.

5 And it's a problem, and it's also a resource 1 6 situation. A factual matter is the use of this agency, 7 like all other federal agencies, is being cut. We just do l 8  !

not have the resources to have a lot of highly 9

prescriptive requirements in terms of how to do something 10 when the technology changes.

11 You know, at one time we would turn around --

12 you would send un an application and tell me, "This is how 13 I'm going to do a contamination survey." And then through 14 a tie down condition, we would make that a legally binding 15 requirement.

16 Well, I can think of six different ways to do 17 contamination surveys. And I'm not at all sure that six 18 months from now somebody might put out a new device that 19 will make it a seventh way to do it and it will be cheaper 20 and better. So the question comes: Why should I turn 21' around and make that a prescriptive requirement when there 22 are six different ways to do it and depending upon where 23 you are and what equipment you own, you might want to 24 change it?

25 So those are the kinds of trends that I see NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

27 j 1 coming.

You'll honr a lot more about this stuff in-the i

2 details. Strategic assessment is important for the i W i 3 Commission. We will be required by -- I don't know --

?

4 Performance in Government Act or one'of the pieces of  ;

)

5 legislation passed in the-last couple of years to develop 6

a strategic plan for the Congress and so, therefore, 4

7 input.

8

'Right now the Commission is eliciting comment l 9 on strategic assessment, the various papers. And if you 10 have any time at all to comment on any of these areas, I 11 think it would be extremely valuable for,you to do that 12 and very useful because basically we have received some -

-~ 13 interesting letters on it in'the medical area complaining

\s- - 14' about the staff performance.

15 I would make the observation be sure to be 16 very careful because some of the things they are

17. criticizing were actually decisions made by the 18 commissioners themselves and not by the staff. And the 19 Commission-is very much personally involved in drafting of 20 these papers.

21 So, anyway, I will turn this over to Dr. Cool.

22 Can I answer any questions?

23 MR. ChMPER: This is the opportunity to talk 24 to the office director if you have any questions or if you x,,/ 25 have just a philosophical observation or whatever. Dr.

NEAL R. GROSS count REpomuns AND TRANSCREERS 1323 rho 0E ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

28 1 Lipoti?

i 2 DR. PAPERIELLO: Yes? 1 l Ij 3 I DR. LIPOTI: Well, it's a philosophical 4 observation.

5 DR.'PAPERIELLO: Okay.

6 I DR. LIPOTI: On your analogy with the speed i

7 limit, I might also say that states issue driver's  !

8 licenses and have requirements for those who can drive a 9 vehicle as well.

10 DR. PAPERIELLO: Oh, I understand that. And 11 we would do the same thing. That would stay. You know, l 12 we wouldn't -- but I'll give you another analogy. You 13 have to pass an eye test. But if you don't pass, I'm not  !

i 14 going to remediate your -- you know, you go to somebody i

15 else to do that.

16 So you're right. We would anticipate that.

1 l

, 17 Yes. And it's all proportional. I tell people there are 18 a few things -- and this is where risk-informed comes in. '

19 You're familiar with radiography. Yes, I'm  ;

{

20 going to keep about four prescriptive requirements in l

' l 21 radiography regardless. Why? Because it's the smart  !

22 thing to do. There are a couple of things that will get l x

23 you in a whole lot of trouble very, very fast. And there  !

24 are some very simple ways to avoiding that. And if I can  !

1 1

25 pass a few' simple rules -- you know, what I mean by that j i

NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE N.W.  !

(202) 23M33 WASHWGTON, D.C. 200053701 (202) 2W j

29 1 in otraightforward, easy. Always survey a radiographi, p 2 camera. I'll make that prescriptive requirement.

\

i 3 States have prescriptive requirements for 1

4 cars. You want two headlights. They will be so big and 1

5 all that. But that's sort of straightforward.

i You know, i 6 we have something called reckless driving. We also have i 7 defensive driving. But trying to be very prescriptive on i I-8 how you do that is an extremely difficult sort of thing to 9 do.

10 So yes. And that's why when the Commission 11 says risk-informed, performance-based, it is how much risk 12 really is.there. You know, that's a measure.

13 You can't put the same amount of emphasis on' C 14 everything. Certainly there's the aspect of resources, 15 but there's also the fact that we have a very large 16 infrastructure right now; well, for example, medical 17 physicists.

18 That as a profession has come into being over 19 the last 20 to 30 years. So maybe 30 years ago it was a 20 very few practitioners. And today you have professional 21 associations. They have consensus standards out. Well, 22 use them. You know, that's where I'm coming from.

23 MEMBER FLYNN: The only comment I'd like to 24 make is philosophical also. And that is in terms of like

\ 25 what I hear from licensees is in terms of enforcement, NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000M701 (202) 234 4 433

30 1

that onco you do brack tha epard limit, that the reaction 2 to that is proportional to the amount that you broke the

( }

3 speed limit by because you're expecting the driver of the 4

car to pull over to the side of the road and voluntarily l 5 report that they br ke the speed limit.

6 And then someone shows up and checks the trunk 1 7

and checks the pressure on the tires and checks the entire

^

l 8

and then really maybe drags that person through a long 9

inspection process, which may be beyond the scope of the 10 violation.

11 So I think to encourage people to voluntarily 12 report that they broke the speed limit, I think the 13 response to the violation should be proportional and 14 should not be too punitive to discourage voluntary 15 reporting.

16 DR. PAPERIELLOi Yes, I understand what you're 17 saying. I will tell you, though, from my experiences, 18 when I look into events, sometimes you've got to look 19 beyond the reported event. I have an AIT out right now, 20 an augmented inspection team. A portable gauge is 21 considered a device which has very low risk.

22 I have right now an acute overexposure, a 23 person showing erythema and blistering of hands. This is 24 the nuclear equivalent of putting your fingers in an 25 electrical socket. This person actually handled the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

31 1 courco with thair hands for a couple of months and the A 2 whole body badge for the last two months, so something 1 3 like 12 rem. This is a 10-millicurie cesium source. You 4 don't ever expect anybody to do that with a gauge or ever 5 have this sort of thing.

t 6 Now, when I look into that event, I am looking 7 at everything. Why did it occur? Why'did the individual 8 do what they did? What was the management. doing? And 9 since the company owns a number of branch offices around '

10 the country and, in fact, I license something like 18 of 11 them, I'm going to check the others. I feel I have the 12 obligation.

13 This event is so incredible. Didn't anybody k 14 know what the individual was doing? I mean, it's an 15 incredible event. And so, anyway, I'm giving you the 16 perspective as a regulator why we do what we do is to find 17 out what is the underlying cause and how could this go on 18 as long as it went on.

19 You had a question?

20 MEMBER WILLIAMSON: Well, yes, a philosophical 21 comment and a question. I think one of the main issues 22 raised by the NAS IOM report, in which there was sort of a 23 very broad consensus --

24 DR. PAPERIELLO: Right.

25 MEMBER WILLIAMSON: -- of agreement, was that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 2M WASHINGTON, D.C. 200( 5 3701 (202) 234 4433

1 32 1 I it's wrong to hava cuch intenco regulation of a minority 2

of the radiation sources that we use in these related )

3 fields. And I'm getting the impression that NRC has l

4 basically abandoned any attempt to try and heed the i i

5 recommendation that there should be a uniform regulatory 6

apparatus for both byproduct and non-byproduct sources of 7 ionizing radiation.

8 DR. PAPERIELLO: Let me put it this way. I  !

9 would like very much for there to be a unified system 10 personally, but I will tell you from what I have seen, I 11 don't have -- and it's not only in medicine. It's not 12 only in medicine. It's other areas, too. Okay? I mean, 13 without going in because there are a lot of other federal 14 agencies involved, and I don't want to get into -- I'm 15 just saying.

16 What happened is the response,.the IOM report 17 comes -- we have states telling us, " Don't you do this 18 because we're not going to pick it up." I mean, the 19 agreement states are -- in other words, if you read the 20 volume of input -- and it's not my decision. I mean, I'm 21 standing back and watching the Commission.

22 And the other thing that has happened, of 23 course, is we got'a new Commission. I'm telling you. I 24 mean, you can read in the strategic assessment papers what 25 the Commission is saying. And I'm telling you that is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISI.AND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

4 33

, 1 Commission saying it. The people think that the staff is

/'~'s 2 putting words in the Commission's mouth. The staff is not t

V) 3 putting words in.

4 Yes, we drafted the things and all of that, 5 but I can tell you that the Commission personally looked l

6 at all of that stuff, number one. I've spoken to

7 individual commissioners, and they~have given me their a views. And, in fact, we have a lot of written input from 9 agreement states, from non-agreement states, even in i

10 public meetings from various portions of the regulated j 11 community.

t 12 I'm not trying to lie to you or distort this, e^s 13 You know, as a regulator, this is one of the -- probably

' 14 of the things that I have to regulate, this is about the 15 most frustrating thing.I have to do. I'm not --

16 MEMBER NELP: Isn't the overwhelming input in 17 favor of getting uniform regulatory guidelines for 18 everything because --

19 DR. PAPERIELLO: I think people --

20 MEMBER NELP: If you say, "I have X comments,"

21 what I see are the comments, if the Society of Nuclear 22 Medicine, the American College of Physicians, and the 23 American College of Radiology make a comment, that 24 represents thousands of people.

ON/ 25 And I see you say that's a letter. Really, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4 433

34 1 thsy're not given any wsight. An I recd through, thny'ra 2 not given equivalent weight. An individual can make a 3 comment, and that doesn't seem to weigh as much. It seems 4

to me you're adding and subtracting all of these things as 5 a society or group of thousands of people.

6 How do you feel about that?

7 DR. PAPERIELLO: I hear what you're saying.

8 Again, I can't speak for five commissioners.

9 MEMBER NELP: No. I wanted to know how you 10 felt about it, not the commissioners. I 11 DR. PAPERIELLO: I see it somewhat different. l 12 And that is, for one thing, -- and there are going to be 13 discussions today -- for example, I think.the question is I l

14 how we regulate by risk. Diagnostic nuclear medicine  ;

1 15 certainly is far less the risk than therapy. And I think 16 there's a lot of room there for relief. And that might 17 solve the problem.

l l

18 I can't turn around and make up the )

l 19 commissioners' minds. I'm just telling you what I'm 20 seeing going on. We have had a lot -- I don't want to say tremendous.

21 I don't know. I can't quantify how many 22 pieces of correspondence that we've received in the last 23 year. And the Commission has asked for it.

24 They've read it insofar as they read or their i 25 staff, their personal staff, reads and tells them what it  ;

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

35 1 eaya.

We hava had commento, and we have received input l g\ 2

/

t for those who didn't show up at the meetings on strategic )

V) 3 assessment.

4 I'm trying to share with you where what I i 4

5 think this Commission is coming from. You know, that's l 6 why I take my direction from.

7 MEMBFD NELP: I understand. Thank you.

8 DR. PAPERIELLO: You know, I don't know how 9 they quantify things. And I'm telling you I find it a 10 very difficult area to regulate because it's a hell of a 11 lot of -- everybody has very, very strong opinions on the 12 thing. Okay? So I just wanted to share with you where I 13 think things.

A 14 And you're going to haar more about what's in 15 all of these papers. My personal view is the kind of 16 direction I'm getting from'the Commission generally, 17 putting even aside medicine and getting into just the way 18 the agency regulates, is: Can you regulate based on less

19. prescriptiveness on how you do things and regulate just 20 based more toward performance? This is where you have to 21 be.

22 And the decision on how much to back off will 23 be a function of risk. As I said, radiography, if you 24 look at almost every one of your events, inevitably you q] 25 find out somebody either didn't have or didn't use a NEAL R. GROSS COURT P.EPoRTERS AND TRANSCRISERS 1323 RHoOE ISLANo AVEL. N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433

36 1 curvey inctrum;nt.

2 That's just a fact. That's the empirical ( l 3 data.

And so, therefore, if I turn around and there have 4

a very prescriptive requirement, you will have, you will 5

calibrate, and you will use -- and the other thing we have 6

made them do is wear alarming dose rate meters.

7  !

In the NRC area, in the air states we i 8

regulate, there has been, I would say, a dramatic drop in 9 overexposures for radiographers.

10 MEMBER SWANSON: A question. As it comes to 11 what we're doing here today, are we to assume that the NRC 12 commissioners have decided on Options 2 and 1, I believe, 13 in here and we're not to comment on the other options?

14 DR. PAPERIELLO: You should comment on 15 everything. If you will read, I think the thing says the 16 Commission'e preliminary views are these.

17 MEMBER SWANSON: Let me ask you this question, 18 then. This Advisory Committee met last spring, discussed 19 the situation, gave our advice. Do the NRC commissioners 20 really think that we're going to change that advice?

21 DR. PAPERIELLO: I don't know.

22 MR. CAMPER: Dennis, when I start getting into 23 this, I will set the stage and set the stage for both 24 aspects of this. I'm going to revisit what the Committee 25 did before.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234M33 WASHINGTON, D.C. 20006-3701 (202) 234 4 33

37 r

1 One of the things we're going to ask the '

2' Committee to do is you may comment on DSI 7 and 12 as you 3 choose to do so. That's one thing we are soliciting from 4 you: comments or DSI 7 and 12.

5 Then we'll also ask you to provide us with

-6 comments if we operate on the assumption that'if the l

)

7 preliminary findings are the way the Commission goes, then i 8

help us react to the charges that the Commission has given l 1

l 9 us thus far in those preliminary findings. i 10 So you'11 be doing both, actually.

11 DR. PAPERIELLO: And you need to understand, 12 too, we do have two new commissioners since August. It's g 13 sort of like, you know, it's wonderful being a bureaucrat

!(' 14 in Washington and watch the election occur and watch the 15 Congress change. You know, it's just part of the world I 16 work in. .

17 And Commissions change. And the views of this 18 Commission appear to be different than the views of the i

19 Commission that we had two years ago. And since they set

]

1 20 the policy and I carry out their direction, that's the way l 21 it works.

i 22 MEMBER WAGNER: Carl, could you just make one i 23 comment on that?'You said that the views of the 1

24 Commission two years ago are different than the ones 25 presently.

NEAL R. GRCSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 2000H701 (202) 234-4433

38 1 DR. PAPERIELLO: That'a my parccption.

2 MEMBER WAGNER:

I Could you enlighten us on your I I 3 perception? What are the most significant differences in 4 those views?

5 DR. PAPERIELLO: I believe the previous j

6 Commission that we had a couple of years ago, their 7

personal inclination was to reduce, if not eliminate, the l 8

NRC involvement in medical uses of radiation. It's not at 9

all clear that the current Commission holds that view.

10 And, in the meantime, we basically have four 11 new commissioners that were not around when the IOM report 12 was commissioned. I'm just saying that's what's happened 13 in the last two years.

( I 14 MEMBER NELP: Approximately what fraction of 15 your budget and what fraction of your FTEs of the 16 Commission are involved in the medical regulatory process 17 of radiation?

18 DR. PAPERIELLO: Don Cool could probably 19 answer that because, in fact, I think I asked him at one 20 time. I don't know.

21 DR. COOL: In very general terms, roughly a 22 third of the materials licensees which we have in the NRC 23 states are related to medical applications. If you take 24 --

25 MEMBER NELP: 1 m talking about the whole NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) A M WASHINGTON, D.C. 20005 3701 (202) 234-4433

39 t 1 chooting match, --

\

',s 2 DR. COOL: Right.

( \

\~- 3 MEMBER NELP: -

':he whole Commission.

4 DR. COOL: And from an FTE budgetary 5 standpoint, something on the order of 50 full-time 6

equivalent individuals between headquarters and regions 7

inspections, license inspectors, license reviewers, 8 otherwise, are involved .n some aspect of the program. I 9  !

Those individuals as a person, say a Sally l 10 Merchant, will also work on other activities but are 11 involved in those pieces of the program, which is slightly 12 over a third of the net FTE resources which I have

,, 13 available in the net materials program within the k-m 14 Commission, which, of course, ranges the entire scope from 15 the gauges to the radiographers to the irradiators to the 16 various medical applications.

17 MEMBER NELP: I don't know if you're 18 including, though, how many employees in the national 19 Regulatory Commission overall.

20 MR. CAMPER: Three thousand.

21 DR. COOL: There are something on the order of 22 3,000 employees in the Nuclear Regulatory Commission. So, 23 of those, about --

24 MEMBER NELP: We're talking about 50 over --

( 25 DR. COOL: -- 50 of them are related to the NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20006 3701 )

(202) 234 4433

40 1 m; dical program out of 3,000.

2 MEMBER NELP: The denominator would be 3,000. ( l 3 DR. COOL: Within the total of the Nuclear 4 Regulatory Commission, that's correct.

5 MEMBER NELP: I wanted to get that 6 perspective. Thank you.

7 CHAIRMAN STITT: Dr. Alazraki is trying to get

, 8 attention.

9 DR. PAPERIELLO: It's relatively small.

10 DR. ALAZRAKI: I have a question which is 11 particularly important to me since I'm not yet a Committee 12 member but perhaps about to be appointed. And that is:

13 How does the Commission view the Advisory Committee? And 14 what is the role of the Advisory Committee? And what is 15 the attitude of the Commission in terms of the ,

16 significance or importance of whatever it is the Advisory 17 Committee recommends?

18 DR. PAPERIELLO: I don't know. I'm being 19 honest with you. I don't know. And this Advisory 20 Committee has been an interesting one because it, strictly 21 speaking, is not an advisory committee to the Commission.

22 It's an advisory committee to, I think, you.

23 MR. CAMPER: That's correct.

24 DR. PAPERIELLO: I think legally. I'm going 25 to tell you something. Of the advisory committees that I NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE , N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

41 1 work with, this is the best.

And I won't elaborate.

fg 2 MR. CAMPER: May I just add to that? Let me

( }

\#

3 just give you a perspective from my vantage point. It may 4 be slightly different from Carl's. Carl is right. We 5 don't know. We don't really know how they value it. I 6 mean, I don't know. We don't know how it weighs in.

7 But what I do know is the following. I do 8

know since 1990 the Commission said to the staff: We want 9

this Committee to meet at least twice a year. We want you 10 to expand the membership and composition of this Committee 11 so that it reflects a more balanced input and a wider 12 spectrum of input.

~~ 13 We have heard this Committee say to us early

\~~l 14 on, going back, say, four years ago,.five years ago:

15 Look', you bring us guidance documents and rules that are 16 essentially a fait d'accomplit. And you're basically 17 asking us to bless them.

18 And we said: Okay. Well, we can change that.

19 And what we have done and what I would submit to you that 20 we do do now, candidly and honestly, is that we come to 21 you as early in the process as we can. We ask you your 22 conceptual input. We ask you to help us develop language.

23 And, for example, tomorrow we're going to ask you to help 24 us develop the inspection guidance for the patient release Q 25 rule.

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

42 1

Now, I don't know what we can do as a staff to 2

make the interaction with the Committee more meaningful 4 )

3 and having more of an impact. My perspective is -- and I 4

would echo what Carl said -- this Committee works like an 5 advisory committee should work. i 6

Now, ultimately how does the Commission view  ;

7 that? I believe they view it as being important, but we 8 can't put ourselves inside of their minds in their 9 decision process. l 10 DR. PAPERIELLO: And I'd say it's more 11 complicated. I really do have a new Commission. That's 12 --

13 MEMBER NELP: But I get the feeling that in l 14 most organizational structures, the Commission would rely 15 on you to tell them what to do. And what I hear you 16 telling us is that you're waiting to hear .for the 17 Commission to tell you what to do. And that doesn't seem 18 how most interactive structures work because the 19 commissioners have to rely on someone to tell them what to 20 do.

21 DR. PAPERIELLO: I'm telling you, at least in 22 this area, it's the way it is, to the best of my ability.

23 Okay? And I'm gi'ving you the benefit of my interaction 24 with those commissioners I've had an individual 25 interaction with on the subject.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000Ml701 (202) 234 4433

d--ia. d.u p.- -4 r444.4 1, e 4-4.a-W.> 28--4 mA -w-5 l. AA,--44 ,e<=-- ~44a-...W .ai- A -s-h*< w& 5+4~.A -- -a.- . 14. 4 4+.m.e .,u.me 3 ..-..A_.-. 4- 4._.ue+-,tA4*+,4,,+S-..

f 43 1

And I told you this is an incredibly difficult

2 area for me. I'm finding this -- it's a very difficult 3

area to regulate because I've had different commissions 4 that wanted to go in different directions. There's not a i

5 great consensus on where to go. And the number of people t

6 with strong emotions on this whole business is just more

7 than I can tell you.

4 8 I have gaseous diffusion plants I have to i

j 9 regulate. I've got a meeting I'm supposed to be right now j 10 on the potential for criticality of SNM that winds up in.

11 contaminated soil and whether or not it's going to migre.te l 12 over a million years or something like that. I'have a lot j7 13 of very, very -- I just never run into the emotions and

){

i 14 the widely differing views that occur in the medical area.

j 15 So it's an interesting thing to do.

1 16 This Committee I find very valuable because j 17 the practical matter is I get advice. If I have to do 1

j 18 certain things, if this is the direction I'm given and I

19 have to do it, I don't have a choice, the Committee is t

[ 20 extremely valuable in telling me practically: If you do

21 it this way, it's a dumb thing to do. And if you do it I.

! 22 this way, maybe the community doesn't like it, but at

- 23 least it's realistic. And that's the reason why this

! 24 Committee I find is extremely valuable.

i 'N I j 25 You have the complete freedom to give the s'

NEAL R. GROSS COURT REPORTERS AND TRANSCfUBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

44 1

i Commiccion whstover vicws you have, but I will tell you 2

that this is one area where they are making up their own i ) ,

3 minds and they are deciding what to do.

4 .

They are not -- we gave them a full range of 5 options.

They have noodled, and their staffs have noodled 6 with those papers. They have given us their preliminary 1

7 viewc. We have gone out and held public meetings.

8 They had the benefit of all of this sort of 9 thing. And they're going to make a decision. It is not 10 going to be the staff's decision. It's going to be their 11 decision.

12 CHAIRMAN STITT: Carl, would you tell us who 13 the commissioners are and briefly something about each one 14 of them?

15 DR. PAPERIELLO: I'm sorry. What?

16 CHAIRMAN STITT: Could you tell us who the 17 commissioners are, particularly the new ones, and briefly 18 something about them?

19 DR. PAPERIELLO: Commissioner McGaffigan is 20 from senatorial staff. He does not have prior background.

21 He's a physicist, Bachelor's and Master's degree in l 22 physics, I think a Master's degree in public policy.

l 23 He was on the -- I can't recall -- the 24 senator's staff for about 12 years. His field was really 25 not this nuclear but I want to say foreign affairs. I i NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

l (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

45  !

1 know hs's vary much interested in things like dispo,sition 2 of surplus nuclear material and things like that. So i

1 3 that's sort of his interest.

4 Commissioner Diaz comes from an academic 4

5 background. He is a physicist also. He apparently worked 6 at one time as a medical physicist. But his actual i

! 7 business right now when it came -- I think it was the  !

8 University of Florida -- involved nuclear space

, 9 propulsion. 1 10 1

That's all I can tell you. I don't know a lot 11 more about their individual interests and backgrounds, but 12 they're the two commissioners we picked up in August.

13 DR. COOL: If the Committee would like, we can O I I

'h 14 probably get brief bio descriptions for them and that sort

. 15 of information before the group disbands tomorrow.

16 CHAIRMAN STITT:' I think that would be very J

[ 17 helpful. We would like that.

4 18 MEMBER NELP: There are how many commissioners 19 total, please?

20 DR. PAPERIELLO: Pardon?

^

1 21 MEMBER NELP: How many commissioners total?

22 4

DR. PAPERIELLO: Five.

.i 23 MEMBER NELP: Five?

24 CHAIRMAN STITT: Other comments? We're taking 25 Larry's time, which is fine, because this is our chance to NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS

1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433 e..

46 1 hnvo nt thano two. So, Don, do you want to make some 2 comments?

3 DR. COOL: Thank you. I'm going to try and 4

keep this extremely brief because I think perhaps most of 5 the philosophical questions you have already addressed 6

with Dr. Paperiello and there are some time constraints, 7 particularly on a couple of my staff people, one in a

particular who was supposed to brief you this afternoon, 9 which we need to tuck in early this morning because I'm 10 about to send her to Chicago, being the nice, loving 11 division director that I am.

12 I do want to welcome each of you here. There 13 is an old Chinese curse that says, "May you live in 14 interesting times." I think that's particularly 15 applicable to where we are right now overall as an agency 16 and, in particular, in the medical use programs and the 1 1

17 directions for all of the materials applications that we 1

18 deal with.

19 You are going to be spending the vast majority 20 of today looking at some of the strategic assessment 21 issues. We have already started into some of the 1

22 philosophy.

23 Yes, the Commission has expressed some 24 preliminary views on the subject. The entire range of 25 options is still open for comment and consideration. It's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVEL, N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

47 1

anybody's speculetion ao to what extent the commissioners e~ 2 may wish to change their views. Certainly, as we have

l

\~- 3 noted, we have two new commissioners, who did not, in 4

fact, participate in the preparation of the preliminary 5 views that were published. And so they still will have to 6 weigh in. So there is a significant opportunity to

7 participate there.

k 8

of particular importance is going to be the 9 comments that you provide there.

And then moving forward 10 from there, some of the advice and preparations that we

, 11 can begin to look at in terms of moving forward -- assume 12 a preliminary view for the moment as one possible starting

,, 13 point and say, "What steps do we need to take?";

\_-) 14 reaffirming things which the Committee has already stated 4

~

15 and still hold strongly, and down to perhaps more of the 4

16 procedural matters.

. 17 How do we make sure that we get the right kind

, 18 of level of involvement and information from the 19 Committee, from the states, who have to play an enormous 20 role and in this case not just the agreement states but 21 the non-agreement states, for whom depending on the way 22 all of this plays out significant impacts could come into 23 play?

j 24 How do we get the professional societies and

( ,)

I 25 the overall medical community and the public, for whom we NEAL R. GROSS COURT REPORTERS AND TRAMCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

48 1

ccem to hnya an enormous difficulty, in fact, at times 2

getting some active participation and views into the q y 3 process of revising the regulations?

l 4 i l

i There's one thing I'm absolutely positive of, 5

that in Calendar Year 1997 we will be revising 10 CFR Part 6 35.

Now, the direction that that revision will take, that 7

is not exactly clear yet, but we are guaranteed to be in a 8 revision process over that time. We have talked a lot 9 about a variety of the possibility things.

10 There are certainly some things that were 11 raised in the NAS IOM report which bear examination, even 12 if you made an assumption that not all of the package 13 would be taken and acted upon favorably by the Commission.

14 There are some things for which the regulatory 15 balance needs to be changed, some increase in certain 16 areas, some decrease in some certain areas, and how to 17 proceed forward with those sorts of things. And so I'm 18 going to be extremely interested in the discussion.

19 Unfortunately, I also am going to have to run 20 around to some other meetings. The augmented inspection 21 team that Dr. Paperiello mentioned a little while ago is 22 another one of the things that I have to go pay attention 23 to.

24 We, in fact, have two special inspection 25 efforts running right now. The other one we have running i

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

49 1

right now hco to do with the facto thct we have some folks 2

)

)

who deal with fabrication of fuel assemblies for reactors.

., (d 3 It' turns out that when they did some i

4 4

inventorying on some work at one of the facilities 5 yesterday, they came up one bundle short. So there are 6

some other little interesting things going on.

7 MR. CAMPER: Oops.

8 DR. COOL: Yes. Everyone's reaction was 9 approximately the same as our reaction. I can answer i

I

10 questions.

11 I think perhaps given the timing if I can get I 12 back a little bit later today -- and by then you will have 13 had some discussions. And that might be a good 14 opportunity to have another interaction in that piece of 15 the process.

16 So unless you've got some particular questions 17 now, I'm going to turn it back over to you, Dr. Stitt, and 18 we can try to move forward with some of the other things 19 on the agenda.

20 CHAIRMAN STITT: Yes. I'd like for us to get 21 going. We've got a lot of territory to cover. And I 22 think we've got the committee members ready to

<I 23 participate. So, if folks will nod their heads, I'd like 24 to turn this over to Larry. There you go. Judith says 4- b 25 get going.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE , N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

1 ,,.

50 1 MR. CAMPER: Thank you, Dr. Cool.

2 Actually, at this point what I will do is make 3 one minor adjustment in the schedule. And that is I'm ,

4 supposed to lead off. We're actually going to have Dr.

l 5 Holahan make her presentation on the Part 33 rulemaking '

l 6- initiative at this point because of her conflict in her 7 schedule.

8 But, actually, Dr. Stitt, I turn the meeting 9 over to you, Madam Chairman.

10 CHAIRMAN STITT: We can just pass this thing 11 around. All right. Pat, do something. We want to get 12 going here.

13 DR. HOLAHAN: All right. I didn't have any 14 flyers or anything to walk you through today. Basically I 15 just wanted to give you a status update.

16 In May, we walked through the draft at that 17 time, advance notice of proposed rulemaking on Part 33 for 18 specific licenses of broad scope. So I just wanted to 19 give you an indication of where we are today.

20 Since that time, we did make some revisions to 21 it. We took into account the Committee's recommendations 22 and suggestions. We made some revisions to the draft rule 23 language as well as some of the questions and again bring 24 in some of your comments.

25 It went up to the Commission. The Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

Q@1 ,;J'

/.5 4*. .$ N ,

51

{ V; g i approved it with two additions, actually three changes.

,x 2 They wanted the definition of broad scope expanded a f'7j2' W#y ik...

f q 3 little bit, which we have done. And they wanted two 4 additional questions added, which we have done so.

5 Now, what I will say is thct it is being 6 published in today's Federal Register. I haven't seen it 7 yet. So it will be coming out later today. And, if 8 possible, we'll try and get you copies down here tomorrow 9 if we get the Federal Register in. But, for anybody who 10 is interested, the reference is 61 FR 58346 in today's 11 Federal Register.

12 The two questions that we have added since you 13 last saw it are one asking: Should the NRC consider the 14 risks associated with internal exposure pathways, such as 15 ingestion, inhalation, or absorption, separate from those 16 associated with extarnal radiation? And basically the 17 question was raised because obviously there are inherent <

18 uncertainties, more with trying to estimate internal 19 exposures and are the risks any different.

20 We're just basically posing the question for 21 comment as to whether or not -- it is not how we currently 22 have it in Part 20; the underlying basis for Part 20 is 23 using the total effective dose equivalent which assumes 24 you're summing internal and external exposures. And so at 25 this point, we're just seeking whether or not there is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

52 1 intersat in th:t.

2 The other question that we added is, what 3 balance should be maintained between a performance-based 4 and a prescriptive approach to regulating broad scope 5 licensees. As we had discussed at the main meeting, 6 trying to go to a more performance-based approach just 7 indicating that licensees should develop procedures to 8 address certain aspects, but not telling them exactly what 9 should be in those procedures and exactly how to run their 10 program, but what type of balance should we maintain for 11 broad scope licensees.

12 For example, there'n some very prescriptive 13 requirements in Part 34, for example, for radiographers, 14 and in other parts of the regulations, or as Part 20 has ,

15 some more performance-based; for example, develop a l

16 radiation safety ALARA program, and also the occupational 17 dose limits. We don't tell licensees how to meet them; we 18 just indicate that they must meet the occupational dose 19 limits. So that's the other question we' re also seeking 20 comment on.

21 So the Federal Register has 11 questions: the 22 nine which we discussed before and the two additional 23 ones, and the draft rule language. And we're seeking 24 comments on all of it. And so the comment period, I don't 25 know the exact date of closure; again, I haven't seen the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

l i

53 1 notice, but it's 90 days, a 90-day commtnt period.

2 So, any questions or comments?

(D a

,V ~ 3 CHAIRMAN STITT: Anything to address to Dr. l l

4 Holahan, and also Sally said she will get us copies of 5 that. So we'll probably have it before we leave town this 6 week.

7 DR. HOLAHAN: Okay. Thank you, Sally. i 8 CHAIRMAN STITT: Other comments, commentary 1

9 questions?

10 MEMBER NELP: Can you send that announcement 11 to us, to the committee members?

12 DR. HOLAHAN: We'll try and get it down to you 13 tomorrow. If we haven't got it by tomorrow we'11 send it O l 14 out to you. l 15 CHAIRMAN STITT: Okay, thank you. Have a good i 16 trip.

I 17 DR. HOLAHAN: Okay, thank you.

18 CHAIRMAN STITT: Then I believe, we're ready 19 to move on to Dr. Larry Camper's rest of the morning. And 20 Larry, will you let us know when you feel it's time for a 21 break? You can shuffle your agenda.

22 DR. CAMPER: Okay. Depending on how I'm able 23 to dodge the arrows. If I get too many holes in me I'll 24 call for a break.

! 25 CHAIRMAN STITT: All right. We have between NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOF ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000!W5701 (202) 234-4433

54 1 now and 12, unloss we nssd to altcr that.

2 DR. CAMPER: Well good morning, again, as a 3 speaker this time. I found some of your questions and the 4 probings of Dr. Paperiello to be extremely interesting, 5 because I think what you're really wrestling with is this 6 question of the scientific technical issues being managed 7 under a political process.

8 But it is our process, and picking up just 9 quickly on Dr. Nelp's comment, yes the staff certainly 10 does prepare comments and positions and we often go to the 11 Commission with a particular proposed rule, for example.

12 And the Commission and their staff wil',

13 examine that rule and will come back and say fine; do 14 this, do that, change this, change that, take out item 7, 15 or no you're all wrong, and so forth and so on. So 16 certainly Dr. Nelp's observation of the staff of agencies 17 certainly take to the political appointees, a position; 18 that is certainly true. And we'll do that here; we have l 19 been doing that.

20 But as Carl was pointing out, my observation 21 is that this Commission is a very hand's on Commission, 22 very motivated to actively pursue their own postures and 23 positions. Strongly opinionated in a number of ways, l l

24 which is fine; they're very bright, competent folks. But 25 it certainly is a different situation for the press we've NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

55 1 ceen in the past. I think a batter one in many ways, e' 2 But one of the things that we want to do in V 3 the medical area -- and I'll talk about this perhaps over 4 the course of the next several hours -- is we are 5 preparing a Commission paper now for the upcoming annual 6- medical briefing. And one of the things that we're doing 7 or going to do in that Commission paper that is somewhat 8 unusual is, is ask the Commission for guidance on certain 9 major items.

10 If we are to proceed, if one assumes that the 11 preliminary as expressed in DSI 7 is the ultimate i 12 Commission position, there are several things that we 13 would like to hear from the Commission before we proceed (p-_ )

'\_/ 14 to make a suggested revision to Part 35.

15 There a~re major items like: what about l

l 16 misadministrations; what about the 1979 medical policy 17 statement; what about the quality management rule; what 18 about diagnostic use of (indiscernible) and materials?

19 Are we ready to make a significant paradigm adjustment in i l

20 those areas? j 21 And these are policy issues that only the 22 Commission can decide, because in the final analysis they 23 decide policy. They are appointed by the elected t 24 President of the United States, they are approved by the 25 elected Senate of the United States, and they are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

56 1 reprc=cnting the public at large; cnd thcrafore, they are

[ 2 the policy-makers and we will carry out their wishes, 3 whatever they might be.

t 4 So anyway, just a moment of philosophy. Let 5 me tell you what we're going to try to achieve today.

6- We're going to discuss with you the strategic assessment 7 initiative as it relates to DSI #7 and 12; we're going to 8 ask you a number of questions -- and let me just real 9 quick, move through these slides here real quick. I guess 10 we'll go through them in order.

11 Anyway, we're going to discuss the strategic 12 assessment initiative, and at some point I'll be focusing 13 you upon some questions. I must tell you, in the six or 14 seven years now that I've been working with this committee 15 -- having previously been the medical section leader, 16 having now been the branch chief for almost two years --

17 I think we're at a point now, if we assume that the 18 Commission will go with its preliminary findings, we are 19 now in a position to have a profound impact upon changing 20 Part 35.

21 As Don Cool pointed out, Part 35 will undergo 22 a revision; of that there is no question. What it looks 23 like and what it consists of, I think we are now at a 24 point from the ground level up, to strongly influence 25 that, and I believe this committee will play an active NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

57

1 role in doing that. We certainly will go through

,~s 2 painstaking detail with you, and we'll give you every

( )

\~ / 3 opportunity to influence what it ultimately looks like.

4 And I think that your opinions are highly

. 5 valued; certainly by the staff and by the Commission. So

6. I think it's, as they say, it's showtime.

i And so it's 7 going to be kind of interesting.

8 Okay. So we're going to talk about strategic 9 assessments. Let me just quickly tell you about strategic 10 assessment; though I have George Pangburn in the back of 4

11 the room, I'll give you just a snapshot. If you have any 12 questions, George is a senior member of our staff who's 13' been. working actively on the SA initiative for some time

,f}

( ,/

14 and George can answer your questions far better than I can )

15 about the SA initiative.

16 But it's a process that began in August of 17 1995; it was completed in April 1996, or at least the 18 phases where we are now. A steering committee was 19 organized to assess where the agency is today and to 20 examine the current NRC functions and activities. The 21 staff was requested to provide each activity presently 22 being performed by the NRC, as well as it's bases, such as 23 statutes, regulations or commission guidance.

24 In other words, what do we do, how do we do r~54 25 it, why do we do it? And then ultimately the plan is to i (N_ /

NEAL R. GROSS CoORT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20005 3701 (202) 234 4433 1

58 1

go through four pharca to develop a otrategic plan which 2 will then carry the Commission's regulatory activities 3 into the next century. As it relates to the medical area, 4 the two --

5 (Off record discussion.)

6 Now, as I was saying, the area of the l

7 strategic assessment initiative that most directly applies '

i 8 to us is the direction setting initiatives identified as 9 #7 and #12, and we'll talk about them in considerable l

10 detail.

11 Do you have any broader questions about the l 12 strategic assessment initiative at large?

13 MEMBER NELp: I had one question; I may have 14 overlooked it. But who authored, who is the principal 15 author of DSI 7?

16 DR. CAMPER: The principal author of DSI #7 17 was Dr. Josie Piccone, who is now branch chief, who was 18 previously the medical section leader. Dr. Holahan 19 participated in that as well. Let me tell you though, 20 very interestingly -- and George can comment if I go awry here because this has been a very closely-controlled 21 22 situation.

23 Senior staff members were selected as authors 24 of the papers, to prepare the papers, and then through a 25 very controlled process in which those senior members of h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

- = - . . . - . - . .- -- _ ___ _ . _ - . - .

59 1 tha staff -- authors, if you will -- interfccad with 2 certain selective senior managers to ultimately develop l

3 the paper in close consideration and interaction with the 4 Commission.

5 Throughout that process, one of the things 6 that was done is, those managers, such as myself or Dr.

7 Cool or Dr. Paperiello, had no opportunity to influence i

8 the outcome of those papers. Dr. Paperiello, for example, l 9 the office director, two levels of management above me,

10 did not see the papers for example, until they were well 11 along in the process.

12 I was provided a copy of the papers and 4

/m 13 attended a briefing on the content of the positions

( T

\y 14 shortly before their public release. The theory behind d

15 that was that if we have a senior level individual who 16 knows the program area, and through a controlled process 17 and close interaction with the Commission, those managers 18 down the line, although they might know the programs very 19 well, they also have a vested interest. And the idea was 20 to lend credibility to the process by exercising such 21 control.

22 George, is that a fair assessment?

23 DR. PANGBURN: This is George Pangburn from 24 NRC staff. The other thing too, was that the Chairman was I 25 seeking to have the richest possible set of options, and G

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

60 1 ths term that was uced in the developmsnt of these options 1

2 was to use out-of-the-box thinking; to attempt to provide 3 the Commission with a broad suite of options for their 1

4 considerations, and therefore to remove the individuals 5 1 from their normal work environment and from the normal '

1 6 review and concurrence mode, in developing the papers that 7 ultimately went forth to the Commission. l 8 So, Larry was right, but I just wanted to add 9 that additional dimension to that.

10 DR. CAMPER: Okay. Let's move ahead to the

11 next slide.

12 (Slide change.) i 1

13 DR. CAMPER: What I thought I would do is just 14 sort of quickly, for the matter of the public record and Gi 15 perhaps to resurrect some of your previous thinking, and 16 for the benefit of our new members and guests and so 17 forth, sort of just a quick overview of how we got to 18 where we are. I won't belabor many of these early slides 19 very much; you've seen them before; you've read the IOM 20 Report and so forth and so on.

21 But certainly we need to just set the stage.

22 And what I'm going to try to do over the next half-an-hour 23 or so, 45 minutes, is to set the stage, to turn the 24 discussion over to the Chairman, and lay at your doorstep 25 the various issues and questions that we need your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

61 1 assistance in as wa react to DSI #7 and 12.

7-~

2 Well, obviously, we had a National Academy of

%- 3 Sciences Report as you know. This report of course, came 4 about as a result of a request by the Commission to be an 5 independent assessment of our medical use program. That 6- report was motivated -- that contract was motivated by 7 really two things.

8 On one hand we had been getting criticism from 9 the regulated community, particularly the nuclear medicine 10 component of the regulated community, that our regulations 11 were overly prescriptive, certainly too much for the risk 12 involved. The quality management rule certainly was not 13 favored by some.

O N ,) 14 At the same time, unfortunately, then came 15 along an event in 1992 in which a patient fatality 16 occurred involving an iridium-192 source. There were 17 subsequent Congressional Hearings by Senator Glenn. And 1

18 so the Commission thought that perhaps the most prudent 19 thing to do would be to have an organization with an 20 appropriate pedigree take an independent look at our 21 program. So that's what the Institute of Medicine of the 22 National Academy of Science did.

23 We asked them to look at three major goals.

24 These are global types of goals. Again, I will not belabor 1

v) f'h 25 them; you've seen them before. But basically it deals NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000M701 (202) 234-4433

62 1 with thic qusction of ovar 11 rick; what are the broad 2 policy issues that come to bear; and some critical 3 assessment of the framework that might be used to 1 4 regulate.

5 (Slide change.)

6 DR. CAMPER: We did seek specific 7 recommendations. We wanted a recommendation on a uniform 8 national approach to the regulation of ionizing radiation 9 in all medical applications, and appropriate criteria for 10 measuring the effectiveness of the regulatory programs 11 needed to protect public health and safety.

12 (Slide change.)

13 DR. CAMPER: There were three types of 14 recommendations: recommendations to Congress, 15 recommendations to the NRC, and recommendations to the 16 states and the CRCPD. The cummittee, you might recall, 17 recommended that Congress eliminate all aspects of NRC's 18 medical use program under Part 35 and conduct activities 19 under Part 20 as applicable for medical uses.

20 (Slide change.)

21 DR. CAMPER: And there was another 22 recommendation that Congress direct the Secretary of 23 Health and Human Services to support, coordinate, and 24 encourage the following activities -- and there's a list 25 of things that DRHS should do as a guiding Federal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 2 % 4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

. - - ._ -. . ~.. .. . . _ ._ .

63 1 regulatory proconce; guidance primarily in nature, not i

i (N 2 regulatory, V) e 3 (Slide change.)

4 DR. CAMPER: And that just finishes up the 4 5 list of things that this agency was to do.

6 (Slide change.)

7 DR. CAMPER: There was a recommendation to the 8 NRC that we shculd immediately relax enforcement of 10 CFR 9 Part 3'.32 5 and 35.33; that's the quality management rule 1

10 and the reporting requirements for patient notifications 11 involving misadministrations.

r 12 (Slide change.)

13 DR. CAMPER: They recommended that we initiate U 14 formal steps under the Administrative Procedures Act to 15 revoke Part 35 in its entirety if Congress did not react 16 to the committee's recommendations in a 2-year period.

17 (Slide change.)

18 DR. CAMPER: The committee recommended that 19 NRC separate the cost of formulating regulations from the 20 cost of administering those regulations. In other words, 21 they felt that today your fee structure is such that 22 you're capturing costs for the development of regulations 23 as well as the implementation of those regulations, and 24 that really they ought to be separated and that states for n

( 25 that matter, should bear some of that cost.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20004-3701 (202) 234 4433

l 64 1

1 (Slida chcnga.) ]

2 DR. CAMPER: The committee had some 1

3 recommendations for the CRCPD, and basically they were i

(

4 saying that what you should do is incorporate into the 5 suggested state regulations, those parts of Part 35 that 6 are relevant concepts, but those concepts weren't really 7 defined.

8 (Slide change.)

9 DR. CAMPER: The committee recommended that 10 all State legislatures enact enabling legislation to 11 incorporate the regulation of reactor-generated byproducts 12 into existing state regulatory programs. And I suspect 13 that as we go through this discussion today, I'm sure that 14 I'll get the question -- and I think I know where it will 15 come from -- as to, you know, why didn't they go with the 16 IOM recommendation? Why not?

17 And I think that if you read the section 18 called " Impacts" in DSI #7, while the Commission never 19 comes out and says yes or no to the IOM recommendation, I 20 think that the best place to capture the reaction to it is 21 within the impact section of DSI #7.

22 And certainly one of the things that I read --

23 this is from my perspective as I re.ad the Impact Section 24 of DSI #7 -- is this question of the states. You know, 25 Carl alluded to this a while ago. Many states weighed in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON D.C. 20005-3701 (202) 23M33

1 65 1 against the IOM rccommendation; thay view:d it as an n 2 unfunded mandate.

f I

\ /' 3 The Department of Health and Human Services 4 was opposed to the recommendation; it felt that a 5 compelling case had not been made in the IOM Report, and 6- it doubted that the Congress would put in place the 7 resources for such a program to be conducted.

8 So I think if you ponder why did they not go 9 with the recommendation as presented, I think you'll find 10 the best explanation in that part. But I think -- the 11 point I'd make is, this question of causing state i i

12 legislatures to do things is a very difficult thing to I 13 overcome.

7-s

(- ,

14 (Slide change.)

15 DR. CAMPER: The committee recommended that 16 the CRCPD and the states continually re-evaluate their 17 regulations and procedures -- basically keep your 18 regulations state-of-the-art, address the emerging 19 technologies and scientific developments and so forth.

20 (Slide change.)

21 DR. CAMPER: Now, we discussed the report of 22 course, with the committee, the ACMUI. And the committee 23 did not endorse the IOM recommendation necessarily, 24 either. You took a slightly different viewpoint. You 25 thought that many of the mechanisms and so forth in there s

NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE N.W.

l (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

66 1 ware worthwhile. You agreed with soma parts of it; you 2 disagreed with some parts of it.

3 But basically what you preferred was an 4 Alternative D. I think it was referred to as Alternative 5 D with teeth, or something of that nature. You might 6 recall that Alternative D was the alternative preferred by 7 the IOM.

8 But basically, one of your fundamental 9 differences was, you felt that the agency, the Federal 10 agency that was involved, shouldn't really just be a 11 guiding agency. It should be an actual, substantial 12 Federal oversight, and that was the teeth part.

13 You felt there should be some mechanism in 14 place that would cause states to do certain things and 15 cause the licensees to have viable programs and so forth.

16 You w looking for a mechanism to ensure compliance of 17 the .ces and users, such as linkage to Medicare 18 reimbursement. I think we had a fair amount of disccssion 19 about the Mammographic Quality Assurance Act and how it 20 works -- and if you don't have your machines undergo an 21 evaluation, you can't be compensated for said mammogram --

22 and you thought that was a reasonable approach.

23 You recognized the problem with uniformity of 24 state regulatory programs. Let me echo something that I 25 know that Dr. Nelp has on his mind from his comments NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

67 1 carlier this morning and certainly from my parapactivo as e- 2 a health physicist, a medical physicist. I spent some

\ /

'- ' 3 part of my career out in the private sector; I did 4 consulting. We had clients in 26 states so I've seen a 5 lot programs. I've seen all five NRC -- or, four regions; 6- I've seen a lot of states.

7 There's dramatic differences in programs, and 8 I would love to see a national approach to how we regulate 1

9 the use of ionizing medicine and radiation. I think 10 though, we have to recognize the reality of the political 11 process, in which we're trying to manage a scientific 12 technical issue, and it's very, very difficult to achieve j 13 that --

although it is a worthwhile goal. l tN l k,s 14 Dr. Wagner?

15 (Slide change.)

16 MEMBER WAGNER: I'm sorry, I want to go back 17 to that slide, because I have a comment on a few things 18 there.

19 DR. CAMPER: Sure.

20 MEMBER WAGNER: I believe the reason we had 21 substantive Federal oversight, I think the argument that 22 was given as I recall, was because at individual state 23 levels there may not be the expertise necessary to develop 24 uniform guidelines that are of a sufficiently-high level l

) 25 to be satisfactory for all states.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 VWSHINGTON, D.C. 20E3701 (202) 2364433 l

68 1 Tha tooth part of it was the encond thing, 2 which was the mechanism to ensure compliance, was the 3 Medicare reimbursement. And I think that's the way we 4 came about it.

5 DR. CAMPER: Fine, sure. Good point. Okay, 6 next slide.

7 (Slide change.)

8 DR. CAMPER: There was certainly a strong 9 feeling by the committee that we should rebuild the 10 medical use program. Do not use the current Part 35; 11 reassess the objectives of the regulations. Certainly Dr.

12 Wagner, for example, has expressed a lot of concern about 13 the regulations. Why are they the way that they are today 14 and how did we get to where we are today?

15 And one of the questions you'll see that I'm 1

16 going to explore with you is to ask you to share with us, 17 perhaps an underlying regulatory philosophy that could be l 18 used as the cornerstone for Part 35. At some point, if we 19 get to it in this session today -- or if not in this 20 meeting than perhaps the next -- one of the things we're 21 also asking you to do is, we're going to do a critical 22 analysis of the existing Part 35.

23 What's good about it, what's bad about it, 24 what should be kept, what should be thrown out, what 25 should be modified, and so forth and so on. So we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

~. _ _ ___ __ _ ~_ _ __ - ._

69 1 going to do that. But this was cartainly one of your.

irm 2 concerns.

3 You thought that there should be a federal 4 mandate that states administer medical use in a regulatory 5 program. There should be incentives to encourage states 6 to comply. State programs should be monitored by a l 7 Federal agency, and the Federal agenr:y should be an agency_

i

, 8 with overall medical perspective. And the agency that was 9 suggested was DHHS because you felt that they currently 10 monitor or regulate a broad spectrum of medical issues.

11 (Slide change.)

12 DR. CAMPER: You again, thought that it should 13 encompass all uses of ionizing radiation in medicine.

U 14 We've talked briefly about that. And that, conduct the l i

15 medical use regulatory program uniformly, whether by 16 Federal agency or by the states. Again, there's this 17 underlying desire for a uniform approach.

18 (Slide change.)

19 DR. CAMPER: All right. So thus far, what 20 I've done is just try to revisit a little history, just to 21 sort of set the stage, refresh your thinking, and so 22 forth. Now let's turn our thoughts to DSI #7.

23 DSI #7 is that paper which deals with the 24 materials program and also specifically, the medical use 25 program. The paper contains a number of options. The NEAL R. GROSS ^

COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200053701 (202) 234 4433

70 l

1 firct option is that the Commission would incrance 2

regulatory responsibility with addition of x-ray 3 accelerators and naturally occurring and accelerator-  !

4 produced radioactive material.

i 5 That is, as George Pangburn pointed out, the t 1

6 Commission, in the development of these DSIs, was trying i 7 to find a target-rich environment in terms of options. So 8 this option represents the let's grow, let's try to do it 9 all, let's pursue the uniform approach, for example. All 10 activity would be regulated by it.

11 Option Number 2 is to continue the ongoing 12 program with improvements. And you can refer to the DSI 13 #7 as you sit there and listen to these bullets. If you 14 went to look at any of the background associated with the 15 options -- in the interest of time, I can't go through a 16 lot of detail -- so you can look at that on your own as we 17 go through the discussion today. So I'll just cover the 18 options.

19 So the second option was, keep the program 20 that we now have; make some improvements.

21 (Slide change.)

22 DR. CAMPER: The third option was, decrease 23 oversight of low-risk activities with continued emphasis 24 on high-risk activities. In other words, back off on 25 those areas where there is minimal risk, but in those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

71 1 areas where there in higher rick, for examplo, teletharcpy

' -s f s i

2 or high-dose remote afterloading, or gamma stereotactic

(

~-

3 radio surgery, maintain an emphasis upon higher risk 4 activities.

5 This translates -- and if you read option 3 6 you'll even find there's a discussion there as it relates 7 to diagnostic uses of byproduct materials in medicine --

8 is an area that might be a starting point for the low-risk 9 consideration.

10 Option 4 was to discontinue regulation of all 11 medical activities except for oversight of devices and 12 manufacturers. This is essentially the IOM option; to 13 totally back off with the exception of those two areas.

(O,) 14 And option 5 was to discontinue the materials 15 program. Not just medical; I mean, the entire materials 16 program. That would include medical, industrial 17 radiography, gamma irradiators, gauges, etc., etc.

18 (Slide change.)

19 DR. CAMPER: Now, the preferred options was a 20 -- in the preliminary findings -- these are the 21 preliminary findings as contained in the papers which were 22 released in September -- is a combination of option 2 and

23. option 3: continue the ongoing program with improvements; 24 decrease oversight of low-risk activities with continued V) 25 emphasis of high-risk activities; utilize risk-informed NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

72 l i

1 parform:nco-based c.pproach; determine what the low-risk I l

2 activities might be; --

3 (Slide change.)

l 4 DR. CAMPER: -- consult with the ACMUI; and d

5 seek guidance on what the low-risk activities are. Where j 6 the Commission is asking you to tell us what you think 7 that they are, and in so doing, what is your basis for 8 assuming that they are low-risk activities?

9 Consult with the ACMUI on a revision of Part 10 35; we're looking for guidance on implementation methods.

i 11 One of the things that are often -- one of the things 12 that's often heard is the criticism that what the 13 regulations giveth, the guidance and/or inspection process 14 takes away. One of the things we tried very hard to do in 15 the radio pharmacy rule you might recall, was we provided 16 substantial flexibility for the preparation and 17 procurement rate of pharmaceuticals.

18 We have had this committee work with us in the 19 development of the guidance for that and some other 20 guidance modules; we've also used our medical visiting 21 Fellows. So we' re t i ying very hard, and the Commission is 22 saying to us, help us out on guidance and implementation 23 methods, because we want to make certain that as we 24 implement the inspection enforcement process, we're 25 bringing consideration of the ACMUI to bear.

NEAL R. GROSS COURT REPORTERS AND 1RANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 200054 701 (202) 234-4433

73 1 Evolunto the feasibility of using professional organizations; develop professional standards and

,s 2

/ \

w- 3 guidance. Three or four years ago, for example, we 4 examined the possibility of using the ACNP professional audit program that you have, where it's a voluntary 5

, 6 program where physicians can participate; they're 7 inspected by the ACNP. That didn't go anywhere. We were 8 receptive to it then; we're still receptive to it, but 4

,9 there are some problems, not the least of which is that 10 the number of participants was small, it's a voluntary

) 11 program, and so forth.

12 But what the Commission is saying, evaluate 13 the feasibility of using professional organizations for

/*

k, 14 the various components of our program in terms of audits, j 15 inspections, development of professional standards, and so 16 forth.

17 Actually, to help us develop these standards 18 and guidance, one of the things that we certainly have 19 talked about -- I know I've had numerous conversations 20 with Dr. Paperiello and Dr. Cool, and I certainly feel the 21 same way and that is -- to the maximum extent possible, as 22 Carl puts it, the industry has evolved a lot.

23 Today you have organizations such as the AAPM, 24 the ACMP, the SNM, the ACNP -- they weren't around 30 or (Oj 25 40 years ago when we stared regulating the medical use of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 & 3701 (202) 234 4433

74 1 ionizing rrdiction. And parh:ps thare is a stronger role 2

for those organizations to play in the development of 3

standards and guidance, which could be used by this 4 regulatory agency.

5 As Carl puts it, he likes to set the goal and 6

have you and the regulatory industry tell us how we might 7 accomplish that goal.

8 (Slide change.)

9 DR. CAMPER: Now, let's talk about DSI #12.

10 And what I would try to do as we go through DSI #12 is, I 11 want to be very cautious and make something clear up front 12 as I talk about DSI #12.

13 When you start talking about risk assessment 14 you're into a very complex academic area. I think you all 15 recognize as well as I do, there's any number of ways to 16 view risk. I'm going to talk about it in the context --

17 strictly -- of DSI #12.

18 And what I'd like to ask you to do before I 19 step to the slides, is in your briefing books, turn to DSI i

20 #12, because I think it's important to take a look at a 21 couple of the basic concepts that were discussed in DSI 22 #12, and to familiarize ourselves at this point in time, i

23 with what each of the options, briefly what it means, and l l

24 then to quickly take a look at a couple of terms.

25 And the first is that, if you'll look on page NE s.L R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

75 1 2 of that documint you'll see that it cays that thm

7y 2 Commission has established a policy that, to the extent

(' 'l 3 practical, risk insights shall be incorporated into all 4 nuclear regulatory activities. As a result of this 5 policy, the staff has developed a framework for applying 6 probabilistic risk assessment, PRA methods and techniques, 7 and reactor regulation. It goes on to cite that document.

8 But as you read through this document later 9 you'll also find that it points out there hasn't been an 10 equivalent level of effort on the material side 11 necessarily, nor has there necessarily been an industry 12 impetus for such sophisticated approach as PRA; however, 13 the Commission believes that PRA should be brought to bear (x_,,/I 14 in material uses as well.

15 If you look on page 3 it begins to discuss the 16 options. It talks about continuing the current process.

l 17 It says that the current process for pursuing risk-18 informed performance-based regulation could be 19 characterized as an incremental process.

20 Looking at option 2, more rigorously assessing 21 relationship to public health and safety, before pursuing 22 the risk-informed performance-based approach, is this 23 option would require that for new initiatives, the NRC 24 determined that there is the potential for a substantial

/N

i. , ) 25 increase in overall protection to public health and safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

76 1 that would justify ths level of resources neesssary to 2 pursue additional risk-informed performance-based 3 regulatory initiatives.

4 Turning to option number 3, which iv 5 performing comprehensive assessment of NRC regu)' :ory 6- approaches, this is a proactive, aggressive option for 7 moving toward risk-informed performance-based regulation.

8 option number 4 is consider risk-informed 9 performance-based approaches primarily in response to 10 stakeholder initiatives. This option is viewed as being 11 the most responsive to industry and stakeholder 12 initiatives.

13 MEMBER WILLIAMSON: Is it possible to ask a 14 question?

15 DR. CAMPER: Sure.

16 MEMBER WILLIAMSON: I guess the issue is not 1

17 whether to include risk as a factor in making regulations I 18 the option -- that's a given. That is, according to this 19 report. And these options simply clarify the mode of 20 proceeding to integrate risk analysis into current, 21 future, and past regulations, is that correct?

l 22 DR. CAMPER: Yes. It essentially -- it l

l 23 presents four options, and the question that is, which l l

24 methodology to use. The Commission has taken a '

25 preliminary position which we'll step through in a moment.

NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

77 1 What I thought would be worthwhile at this point is just

-~s, s

2 to quickly look at what those options mean in general

\- 'i 3 terms. .It would help to understand which option was 4 chosen and perhaps why.

5 I also think it's very important to point out 6- just a couple of things about some of the definitions and 4

7 so forth. I'd like to draw your attencion to page 10 of 8 the DSI #12. This is discussing a number of internal 9 factors, and one of the factors it points out is defense-10 in-depth.

11 The commission has recognized that reliance d

, 12 for safety should not be placed on any single element of 13 design, construction, operation, maintenance, training, or

\s 14 other activity associated with nuclear facilities or the i 15 use of nuclear materials. Our current regulations are l

! 16 generally deterministic and were constructed around this 4

17 concept of defense-in-depth.

3 18 Therefore, a key element of a transition 19 toward risk-informed performance-based regulation is 20 maintaining defense-in-depth for risk-informed 21 performance-based approaches by appropriately balancing i

22 deterministic-based and performance-based requirements so

23 that defense-in-depth is not compromised.

l 24 Lou?

25 MEMBER WAGNER: I'm sorry, Larry, but I read NEAL R. GROSS J

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

78 1

over thin neveral timas and I'm still confuced on that.

2 MEMBER WILLIAMSON: Yes.

3 MEMBER WAGNER: Defense-in-depth. You throw 4 around these things that obviously, you're familiar with 5 but we're not familiar with these terms; at least I'm not 6 familiar with them.

7 DR. CAMPER: Well, the idea -- in general 8 terms, the idea in the nuclear world is that we have 9 redundant and different systems, and the idea is that if 10 some primary mechanism were to fail, there's a backup; you 11 have defense-in-depth, and that you not rely only upon one 12 approach.

13 And basically what they're saying here is ,

14 that, yes, deterministic effects has been a baseline 15 consideration in the development of our regulations, but 16 in addition to being purely deterministicly determined, 17 there's also this need for defense-in-depth.

18 In other words, I think putting it in a more 19 layman term, is yes, risk is a consideration and risk to a 20 great degree, can drive the level of regulatory effort, 21 but you also cannot overlook common sense in that a 22 particular system that you would put in place may fail, 23 and therefore it is appropriate to have some defense-in-24 depth.

25 MEMBER WILLIAMSON: Could you give examples of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

79 1 current medical use regulations whara defense-in-depth has f- s 2 been an important rule-making milepost or guideline?

(\'") 3 DR. CAMPER: Let me say this. I'll see if I 4 can think of an example, but let me just say the 5 following, as we'll talk about later.

6 I think that what you have -- it's not clear 7 to me that historically we have used the risk-driven 8 approach as the pure guiding principle for development of 9 regulations. I mean, for example, if I look at Part 35 10 today, I would make the argument that if I look at 35.600 11 I'll find in teletherapy, a number of things that are 12 appropriate because of risk in teletherapy; there's a 13 number of quality assurance requirements in there that are O

\m- 14 arguably defense-in-depth -- calibration, safety checks, 15 safety instruction, being quality determination, etc.

16 I think that I would argue that those things 17 are defense-in-depth, and that's probably the best example 18 of Part 35 that I can think of. I would find a similar 19 set of criteria -- although it's not a regulation yet --

20 certainly in Policy and Guidance Directive 86-4 dealing 21 with high-dose rate remote afterloaders, there's a number 22 of prescriptive requirements that we now impose by license 23 condition that are arguably defense-in-depth.

24 But having said that, the thing that I'm O

t 25 j.f struck by is that if I look at teletherapy in 35.600 and I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

80 1 think it's c. bout right in terms of rick, it'c about right 2 in terms of defense-in-depth, it's not all clear to me 3

that when it was created, that that was the guiding logic.

4 What I mean is the following.

5 In 1979, when we put~in place the requirements 6 in 35-600, it came about as a result of a catastrophic 7 series of events that occurred at Riverside Hospital in 8 Ohio, in which 275 patients or something of that order, 9 were over-exposed; there were a number of patient deaths; 10 there were autopsies that demonstrated that there was 11 radiation consequences and so forth.

12 So then what happened is, we developed a 13 regulation in reaction to an event. And we've done that a 14 lot over the years. Let there be no question about it; we i

15 have reacted to even singular events and have put in place '

l 16 fairly prescriptive regulatory requirements. It turns out 17 that I can readily use 35-600 because I think that it is 18 about right in terms of risk, and it certainly is 19 redundant.

20 But again, was that the principle that guided?

21 And I think what I'm hearing the Commission say now, as 22 you revise Part 35, use risk-informed performance-oriented 23 as a key consideration in developing new regulations.

24 MEMBER NELP: That's not even arguable, is it?

25 DR. CAMPER: I'm not arguing.

NEAL R GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

i ,

l 81 1 MEMBER NELP: No, I maan, I think we would c 2 say, fine.

l

.\

3 DR. CAMPER: Good.

4 MEMBER NELP: Let's get on with something --

5 the authors of DSI 12 are obviously a different group of 6 people than DSI 7. I mean, this is a very complex, 7 philosophical --

8 DR. CAMPER: No question.

9 MEMBER NELP: -- risk-based, theoretical l

10 approach --

11 DR. CAMPER: Right, absolutely.

12 MEMBER NELP: -- and I don't know what Judith l

13 thinks, but I suspect we would all concur. This is a very

)

O 14 sensible way to approach regulations.

15 DR. CAMPER: Right.

16 CHAIRMAN STITT: Larry, I just want to make a 17 comment. Because we're all the medical community here and 18 a lot of years we have struggled in our communications 19 back and forth with NRC, NRC staff, and the medical 20 community, and if we're going to continue to go forward in 21 this area, I think risk-informed and performance-based --

22 it sounds like practicing medicine. Defense-in-depth 23 sounds like we're at war.

24 I think we need to be very careful to lG 25 understand what we're talking about as we proceed, and I NEAL R. GROSS COURT REPORTERS AND TRANSCRBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

82 1 don't think I want to be diccucsing defense-in-depth. If 2

you want to talk about systems that back up systems and 3 redundancy and duplication, but these aren't medical terms 4 and I think we've really tried to focus on patients and -- I 5 DR. CAMPER: Yes, I couldn't agree more.

6 CHAIRMAN STITT: -- public safety.

l 7 DR. CAMPER: 1 I couldn't agree more. What I'm 8 attempting to do right now is simply step you through some 9 of the background, because of the point that Dr. Nelp has 10 made. This is a very philosophical, academic, complex 11 area. What I'm trying to do is have you think about what 12 is meant by some of the terms as discussed in this 13 document, and particularly bringing you to what is meant 14 by risk-informed performance-based as described in this 15 document.

16 I totally agree with you that the concept of 17 defense-in-depth is probably an offensive term to the 18 medical community. You view it as practicing medicine; I 19 readily understand that. And what I'm just trying to do 20 is get us all calibrated as to what is meant by these 21 terms.

22 With that in mind, let me just draw your 23 attention then, before I go through the options very 24 quickly, to page 18; how risk-informed performance-based 25 regulation has been defined in the context of this NEAL R. GROSS COURT REPOR1ERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

p (202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

. . - - . ~ - - -. . . - - - .

83

! 1 documsnt.

<ss. 2 Risk-informed performance-based approaches use

( ') 3 risk insights, together with deterministic analyses and i

4 performance history, to develop measurable parameters for i

5 monitoring plant and licensee performance, as well as for l

6 developing criteria for performance assessment, and focus 7 on the results as a primary means of regulatory oversight.

l 8 Then it goes on to say in the following '

9 paragraph, that the NRC inspection manual has tailored the

(

10 concepts of risk-informed and performance-based for 11 inspections into a single definition of performance-based l l

12 inspection. According to the manual, Chapter 0610, l l

13 performance-based inspection is inspection that focuses on 10 I s_/# 14 issues of safety and reliability, with an emphasis on 15 field observations rather than in-office procedural or 16 records review. ,

1 17 In other words, what are they actually doing 18 versus looking at a bunch of records? All right. So then 19 we'll quickly go through the options.

20 MEMBER WAGNER: Can I follow up on that? I 21 Because --

l 22 DR. CAMPER: I keep trying to get off of it 23 Judith, but they won't let me. Go ahead. l 24 MEMBER WAGNER: I'm sorry, but I --

DR. CAMPER: Go ahead.

~

25 That's all right.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

84 1 MEMBER WAGNER: This I think, is one of the 2 vital issues here. Now, I want to make sure I understood <

3 what you just said. When you just read that about the ,

4 enforcement issue here, and focusing on the safety of the 5 operation as opposed to individual factors, are you 6 claiming that this is how it's done today? or is this a 7 statement of philosophy about how things should be 8 reformed?

9 DR. CAMPER: I'm saying that what I am very 10 carefully doing, and purposefully doing, is sharing with 11 you the definition of performance-based, risk-informed, as 12 defined in DSI 12. What that paragraph -- what then 13 happens is -- the impression that I get from reading this, 14 Lou, and like you, I read'it several times -- is that this 15 paragraph is followed by an example of what it seems to be 16 about.

17 And yes, this guidance document exists today; 18 this 0610 exists today. It's undergone recent changes, 19 but it is an example of conceptually, how one can 20 implement this idea of risk-informed performance-based.

And it seems to me to be saying -- and again I'm very 21 22 cautious to say this is how I interpret the document -- is 23 that it means that, look at what's actually being done, 24 what are the operations like as opposed to extensive time 25 and energy being spent on records review -- or perhaps h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20005 3701 (202) 234 4433

. -- - - . ~ _ . . . .

i 85 1 subsequent violations that come from records review, which

(] 2 arguably might be meaningless in context of, or compared

, 3 to, how they actually conduct this program.

4 MEMBER WAGNER: Then I have these comments to 5 make and I'd like some clarification. Now, some time ago 6 I asked for an organizational chart and this has been 7 extremely helpful. Now, we are the advisory committee to 8 the Division of Industrial and Medical Nuclear Safety --

i 9 DR. CAMPER: That's correct. .

10 MEMBER WAGNER: -- but I look up here -- we go i

4 11 up to the Office cf Nuclear Material Safety and l

12 Safeguards, that was Carl -- and now I go up another line 13 and I have Office of Enforcement, and it's way up above --

14 off the line. And we're actually consulting to a lower 15 division much underneath that.

16 My question is, is that, do you foresee a 17 larger role of the ACMUI in not only helping you develop 18 regulations, but also helping you to develop enforcement 19 of policy?

20 DR. CAMPER

Well, yes and no. Let me do the 21 "no" first. Ultimately, the enforcement policy that is 22 developed results from interaction between the Office of 23 Enforcement and the offices involved, whether it's the 24 side of the house, NRR, or whether it's the NMSS side of

• f\

t Q,') 25 the house. The program office puts in place a program; NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433

86 1 lot'a call it -- lot's take tha quality management rulo, 2 as an example.

3 The program office, in this case NMSS, puts in i 4 place a regulation; we implement that regulation. A 5 component of implementing that regulation is to develop  !

6 the inspection guidance for determining whether or not the 7 rule has been complied with by the regulated community.

8 In the course of developing that inspection l 9 guidance, one of the things that also has to take place 1

10 is, NMSS has to interface with the Office of Enforcement 11 to determine what' types of violations, what constitutes 12 violations of that regulation, and what severity level 13 should be associated with those various violations -- be 14 it severity level 1, 2, or 3, or 4 -- and then in the is regulation you'll find published, examples of enforcement-16 violations.

17 Obviously, that list of examples is not all- i l

18 inclusive because it's too voluminous, but you have l l

19 certain examples which we publish for the quality 20 management rule, for example.

21 So the program office works with the office of l 22 Enforcement to develop the associated enforcement activity 4

23 that will be in place for a particular violation for a l 24 particular rule. The Office of Enforcement is working 25 under the enforcement policy for the Commission, which the hl NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

87 i

Commission has approvad.

4 1

And that in contained in a

~s 2 specific document -- it's something, I don't recall the

\_s 3 number of it as I stand here.

4 4

So you have the agency's enforcement policy, 5 you have the program to be inspected and enforced, if need j l

6 be, and you have the interface between those two' offices 7 to put in place that policy. Where you have the greatest 8 opportunity to influence that is, as you work with us to 9 develop the inspection guidance, and as we explore with l

1 10 you your perceptions or reaction to certain types of 11 violations that might occur in the course of inspecting l 12 those regulations.

13 For example, we're going to work with you j

(%

( ) 14 tomorrow to help us -- and by the way, this hasn't been l

15 done before. I don't know whether you appreciate that or 16 not; this is fertile ground we're plowing here. You've 17 now worked with us to develop regulations, you've worked ~

18 with us to develop the regulatory guides to implement 19 those regulations, you're now working with us to develop 20 inspection guidance. So please bear in mind where you 21 are. You know, you're like Lewis and Clark here, looking 22 for the Northwest Passage.

23 But you have the opportunity -- and we're 24 going to ask you specific question about the conduct of r%

25 the inspection of that rule. We're going to also ask you

( }

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WAbHINGTON. D.C. 2000tL3701 (202) 234 4433

88 1 at the anma tims wa do thet, okay, wall whct if -- is this 2 the right approach; does it seem to be about the right 3 level of performance orientation versus prescriptive 4 orientation?

5 What should we do if we find that the licensee 6 hasn't done something? How serious do you think that is?

7 What does it mean? Is it purely an administrative 8 violation? What are the consequences that are possible 9 for not doing something?

10 Your thoughts, your inputs in that regard, can 11 influence the inspection, which can in turn influence the 12 enforcement.

13 MEMBER WAGNER: I think that -- I encourage 14 that kind of evolution of this committee; I would 15 encourage more involvement in that. Because I believe 16 that much of the bone of contention that has occurred in 17 historical past is not necessarily in the philosophy of 18 the regulations as they exist -- I think we all believe 19 the philosophy is a good one because it really puts the 20 focus to the patients and people who are around the 21 environment in perspective -- but it is the enforcement 22 that has been the onerous aspect.

23 And if we can now start looking at how those 24 things gets enforced, and have the medical community's 25 input as to how that enforcement proceeds, because these h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20004 3701 (202) 234-4433

.- - . - - . .- -.. . - . . . . .. . - . . . ~ _ . .

89 1 are medical questions in many anpscts, .I think that would f-'s 2 be very beneficial to the development of a good regulatory U 3 policy.

4 DR. CAMPER: We agree. I think we've 5 certainly hear that very loudly and clearly from the 6 committee on several occasions, and we agree trith you; 7 tnat's why we're pursuing the approach that we are.

8 George, do you have a comment? I 9 .DR. PANGBURN: I just wanted to point out one 10 of the related issues in this particular paper has to do

11. with, is escalated enforcement effective in preventing 12 future violations by materials licensees? We've heard 13 from some people in public meetings that perhaps an  !

O

\s-) 14 alternative approach to ensuring compliance may be 15 something the Commission would want to consider. So in 16 your -- whatever comments this committee develops, they 17 may wish to address that particular issue.

18 .DR. CAMPER: Okay. I think what I'll --

I.9 Judith?'

20 MEMBER BROWN: Larry, I had a question about who the audie'nce is.

21 Who's supposed to read this paper?

22 DR. CAMPER: It is intended for the public-at-23 large. The documents were published publicly in 24 September; we're now going through a solicitation of O

( s- j 25 public comments, and the idea is that before the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE. N.W.

(202) 234 4 33 WASHINGTON, D.C. 20006-3701 (202) 234 4433

90 1 Commission procacda to develop ito stretcgic plan, it 2 wants to have the largest opportunity for input, and it's 1 3 the public-at-large, it's certainly the regulated 4 community, it is everyone.

5 MEMBER BROWN: I think if it's the public-at-6 large we're in real trouble. I couldn't read it. I tried 7 three times with various amounts of caffeine; different 8 times of the day. I found it unreadable.

9 DR. CAMPER: I'll pass that along to the 10 author. George, would you make a note of that, please? l 11 Mcil, it's interesting that you say that, because that's 12 one of the reasons why -- you know, I've read this paper 13 now several times, and it's one of the reasons why I have 14 made a conscious effort to stick very closely to the 15 script on this particular topic.

16 I don't want to take any -- I don't want to 17 exercise any latitude of freedom on this, because this the 18 DSI as developed. I'm not going to comment on the quality 19 of the paper; I think it's a very difficult subject; I 20 think the author has done, certainly a reasonably if not a 21 very good job, of trying to address a very complex topic.

22 But anytime I think, you try to say look, 23 let's put risk assessment into a box about this big, okay, 24 and let's package it and send it out so people can react 25 to it, I think you're in a complicated task.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 200053701 (202) 234-4433

91 1 MEMBER BROWN: I agree it's difficult, but i 7-~q 2 I've noted how many times you've said "in other words" in

'- -3 response to questions here, and I'm begging for those 4 other words.

5 DR. CAMPER: Well, I'll keep trying to do that 6- to the extent I still have that latitude.

7 CHAIRMAN STITT: Larry, just a comment. I 8 spent years on the human subjects committee and it does 9 have a number of people on this committee. Part of that 10 work, you look at consent forms for protocols, for patient 11 therapy. And we are told that this should be written in 12 essentially langua 3e that what, seventh graders or 7-year-13 old -- all right, we're up to an eighth grader now -- can

/'%

\m /)

14 read. But it's very different language than most of the 15 documents that we see here. And I agree with Judith that 16 you tried all those permutations and it's difficult to 17 read this. Very scholarly, as --

18 MEMBER NELP: Actually, I think it's very 19 poorly written; it's very redundant.

20 MEMBER BROWN: I think it also might address 21 Don's concern that not enough public input is given to the 22 agency, and if this is what's going out I can understand 23 why nobody's responding.

24 DR. CAMPER: I understand.

()

25 MEMBER BROWN: Or, not many people.

NEAL R. GROSS I don't COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23& 4433 WASHINGTON, D.C. 20005-3701 (202) 23 & 4433

92 1 want to overstate the caco, corry.

2 DR. CAMPER: I understand. Let me do the 3 following, then, because otherwise we'll find ourselves 4 bogged down in this. It's terribly complex and I was 5 concerned this would happen. But I think unless we can 6 get through this, you can begin -- you can talk about --

l 7 we're going to ask you to react to DSI 7, DSI 12. You 8 react as you choose to do so.

l 9 If you think it's, you know, the best thing i

10 since the Magna Charta, you may say so; if you think it's j 11 poorly written you may say that as well. But in order for 12 that to happen, we need to move through it. With that 13 resolved, I'll take one more question and then I'm going -

14 -

15 MEMBER WILLIAMSON: Well, I hope at some time, someone will spend some time explaining what l

16 17 deterministic, performance-based, risk-informed, and PRA i 18 all mean, and not in such sort of vague, general terms. I 19 really have a very difficult time understanding how they 20 would apply to the area of medical regulation. These 21 aren't terms -- they seem to be very technical and not 22 clear meaning --

23 DR. CAMPER: Well, bear in mind, this is for 24 the agency's program-at-large, not just the medical area.

25 DSI #12 --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

. . - - - - . - ~ - - - . . _ . - . . - - - . ~ - . - - - . . . - . . . _ . . . . . . . . .

93 1 MEMBER WILLIAMSON: We appreciate that but 2 we're-being asked to comment on their ~r'ication to the

't >

3 medical use program.

4 DR. CAMPER: Well, your comment may.be that it >

5 doesn't apply very well, and you have a reason.why you-  !

6 don't th'.nk it' applies, and if that's your posture then so 7 state; that's fine. ,

t 8 Okay, let us then just quickly move to the j l

.9 options, so we can move on. Option number 1 is continue 10 the current process -- the application determined by 3 11 balancing external and internal goals and available 12 resources; apply priority criteria, appendix A. I want to i 13 come back to this as my last comment, because I think it's

( 14 sort of the working man's guide to risk assessment, 15 performance determination -- sort of the blue-collar -

l 16 approach -- which I think is probably very succinct in

[

17 giving us some actual tools.

18 Relationship of the activity, or proposed 19 activity to the agency's commitment to good regulation, 20 considering safety impacts, burden reduction and 21 efficiency.

22 (Slide change.)

23 DR. CAMPER: The scope of activities should be 24 determinsi by consideration of industry demand, safety 25 benefit, ease of implementation, available resources.  !

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W. l (202) 234 4433 WASHINGTON, D.C. 200 5 3701 (202) 234 4433 I

94 1 Option 2 is to ansacs relationchip to public h alth and 2 safety; application determined by cost of the initiative 3 compared to the benefit of the public health and safety.

4 (Slide change.)

5 DR. CAMPER: Priority criteria weighted toward 6- the greatest safety benefit. Cost versus benefit, 7 obviously, as always. Overall impact on NRC and regulated 8 industry; available resources should be considered.

9 Option 3, perform comprehensive assessment of 10 NRC regulatory approaches; maximize internal self- j 1

11 assessment; review regulations and regulatory processes, l l

12 areas to determine areas that can be improved with a risk- l I

13 informed performance-based regulation.  !

14 Option 4, consider primarily in response to Ol 15 stakeholder initiative; determined by the stakeholder 16 demand and ease of implementation.

17 (Slide change.)

18 DR. CAMPER: Priority weighted toward industry 19 initiatives to use risk-informed performance-based 20 approaches to reduce regulatory burdens.

21 (Slide change.)

22 DR. CAMPER: Okay. What were the Commission's 23 preliminary views? I will say that I think that their 24 views move away from some of the academic considerations 25 contained within the options and focus upon doable things. h,1 NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

95 1 Higher risk activities should be the primary focus of

/"N 2 efforts and resources; that's pretty straightforward. And 3 it does apply to medicine, I think.

4 A level of effort of lower risk activities 5 should be determined based upon the impacts upon safety, 6' stakehold initiatives, burden reduction, effect on agency 7 and licensee efficiency. I can readily, for example, 8 translate that into something that might relate to the i

9 diagnostic uses. So that's a workable tool. i 10 (Slide change.)

11 DR. CAMPER: Continue with the current 1 i

12 process, which is option 1, in cooperation with the  ;

1 13 industry, including pilot programs; staff should proceed l

(/)

\~- 14 in enhancing PRA implementation plan, focused assessment 15 of regulations which can be risk performance-based. In 16 other words,. which regulations can lend themselves to this 17 concept.

18 (Slide change.)

19 DR. CAMPER: Consider cumulative impacts such 20 as those which affect safety, stakeholder initiative and 21 effect on NRC licensee and NRC efficiency.

22 (Slide change.)

23 DR. CAMPER: Consider cumulative impacts; 24 continue to evaluate and clarify any technical and/or rN k) 25 administrative issues associated with performance-based NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

96 1 opproaches, inspection activities and enforcement. This 2 gets to Dr. Wagner's concern. In other words, it's not 3 just enough tc have your regulations be performance-4 oriented, risk-informed; your inspection activities and 5 your enforcement must also, because othelvise you'll never 6 get to the ultimate goal of truly being risk-informed 7 performance-oriented.

8 (Slide change.)

9 DR. CAMPER: Perform a thorough review of the 10 basis for the regulations and the process. We've already 11 started that as part of the SA initiative. Identify areas 12 that are now, or can be made with minimal additional 13 effort or resources amenable to risk-informed performance-14 , based approach. I certainly think that Part 35 is clearly 9 15 a candidate for that.

16 And I think we'll have a fairly easy job of --

17 and we're going to do an exercise later today in which I'm 18 going to share with you a brainstorming strategy session 19 that we had a week or two ago -- with Carl, Don, myself, 20 Sally Merchant, Josie Piccone -- in which we went through 21 and tried from a modality approach with risk in mind --

22 and I'm going to step you through that model that we 23 created and I'm going to ask you to fill in the blanks in 24 the model, and then I'll share with you how your findings 25 may line up or may not line up with our findings on that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

97 4

1 particular thought procans, thct modal.

g 2 NRC solicits comments on how NRC should deal N'

, 3 with dual regulation when applying this regulatory

4 philosophy. I don't think there's any question in 5 anyone's mind that there's certainly some differences 6 between some of the EPA regulations and some of our 7 regulations, and how can one sort through those 8 differences and/or dual competing regulatory approaches 9 with risk-informed performance-orientation in mind.

10 (Slide change.)

11 DR. CAMPER: All right. What do we want for 4

12 you to do? We would like for you to respond to the 13 Commission directives given in DSI 7 and 12. In so doing, I

(m, 14 I would ask you to channel your responses into two 15 approaches.

, 16 One would be to comment on the DSIs at large:

1 17 good, bad, indifferent, like it, crazy about it, hate it, 18 whatever. I mean, just comment on them at large. Then if 19 you could, in a second part of that, is to -- if we assume

, 20 that the preliminary finding will be the final decision, 21 what do you think about what we're being asked to do in j l

22 DSI 7 and 12, and how might you help us do it.

l 23 I alluded to this earlier. We're interested 24 in having you develop the regulatory philosophy and p]

g 25 framework for the regulation and medical use. And x-NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4435 WASHINGTON, D.C. 200(ML3701 (202) 234 4433

98 1

cartainly Dr. Williamson hao commented on this previously; 2 Dr. Wagner has commented on it. I can recall those 3 comments.

4 And it would be interesting if the committee 5

could articulate what you think should be the fundamental 6

guiding philosophy for the medical regulation, and how 7

that might then be applied to what Part 35 would actually 8 look like.

9 Developing language to revise Part 35 for an 10 anticipated advance notice of proposed rulemaking. We 11 probably won't be able to do much of that in view of the 12 time constraints that we have today on this particular 13 topic.

14 But if we assume that the Commission goes with  !

15 it's preliminary position, I would think that at some 16 point, there's a good possibility -- a high probability I 17 would think -- Chat we would either use an advanced notice 18 of proposed rulemaking that enhanced participatory 19 process, and in doing that we would be developing either 20 an ANPR or at least an issues paper; that we would go to 21 the public with and say, as we look at revising Part 35, 22 these are the issues, or primary considerations which have 23 been identified. Please comment on what you think. Have 24 we captured all of them, have we missed something, are we 25 about right, are we way off?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

99 1 We might include a strawman language for 4

/G i i 2 example, in that ANPR. We did that or the Part 33

! 3 initiative. We would ask you to help us develop that. I 4 would suspect that at least today, we can have some 5 preliminary thoughts.

4 6 I would think by the spring meeting -- again,

. 7 assuming that the Commission stays with its preliminary 8 position -- we would then be well into the process; we 9 would have an active session that would last several 10 hours; we would actually be developing some of this J

11 language. We'd probably give you a strawman and ask you 12 to react to it.

13 (Slide change.)

(s 14 DR. CAMPER: We're going to want to review the 15 existing Part 35, identify those areas that should be 16 maintained or those areas that should be eliminated or 17 modified. Again, I think that our capacity to do that 18 today will be a function of how we move along, but we 19 might be able to take a quick sweep of Part 35 and give us 20 at least some preliminary thoughts. This is, you know, 21 thumbs-up, thumbs-down, it's good, it's bad, keep it, 22 modify it, whatever.

23 But at some point we're going to need to do 24 that, in rather excruciating detail. Because if we're 25 going to rebuild with a new basis, then we at least need NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

100 1 to examino as part of that process, what wa have and what 2 we would do with it, whatever it might be. -

3 We'd like your thoughts on a plan to assist us 4 interfacing with stakeholders, such as professional 5 organizations. For example, one of the most complicated 6 things that I see in Part 35 is this question of training I

7 and experience. There are economic considerations; 8 there's turfdom that goes on; there's the question of what 9 is the appropriate level of training and experience.

10 I would argue that the authorized user concept l 11 is not the same in 1996 as it was in 1966. And so these 12 things need to be examined, and if we're going to explore 1

13 training and experience questions for example, with the l j

14 regulated community, it will be helpful to us if you would 15 identify those organizations and those players that we 16 should interface with, or some of the key issues that 17 should be explored as we do that. So we're interested in 18 a plan to help us interface with the professional society.

19 Is that all? That's good. Okay. Those are 20 the things that I wanted to say, and again, my purpose for 21 this particular part of the discussion was to revisit a 22 bit of history, discuss with you the DSIs that are 23 pertinent to the medical area -- being number 7 and number 24 12 --

to lay at your doorstep the questions and issues 25 that we need. Some of those come directly out of DSI #7, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

101 1

which the Commission has asked us to go to the ACMUI, and fg 2 to solicit your specific guidance on those issues.

-'~ ,

3 A couple of points in the last slide were  ;

i 4

things that as a staff we had determined that we need your l

5 assistance in. I would point out that, as you step 6 through your discussion of DSI 7 and 12, this is also 1

7 viewed as the opportunity for us to document on the 8 record, the committee's reactions to DSI 7 and 12.

9 And again, I would ask you to look at it both 10 ways: reactions in general, reactions that we assume that

)

11 is going to become a fait accompli, that we would in fact, 12 openly move to implement the Commission's preliminary 13 findings. So we need perspectives on both.

p_, What we're f I

\m ,/ 14 going to do, as we always do, we'll be sending forth your 15 minutes to the Commission, but we will clearly identify i 16 that certain components of the minutes contain the I 17 committee's reaction to DSI 7 and 12, as part of the 18 comment-gathering process for the strategic assessment 19 initiative.

20 So that's all I have to say at this point. I 21 would suggest, Dr. Stitt, that we might take a break.

22 CHAIRMAN STITT: Yes. Let me just take a 23 couple of seconds to talk -- two minutes rather, to talk 24 with committee, and then we'll -- getting those symptoms A

h 25 that it's time to take a break here. But looking at the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

102 1 clock, wn've got b tween now and noon to take a break and 2 come back for discussion, and then the aftarnoon schedule 3 has a, not quite two hours to start.our discussions. So 4 we've got an hour this morning, two more this afternoon.

5 We've been given the overview by Larry and we 6 have the material that we've reviewed, so we need to 7 really jump in and start talking about this in detail. I 8 know there's going to be some very pointed comments that 9 people want to make.

10 MEMBER NELP: Larry showed slides that were 11 ACMUI's recommendations from the February 21/22 meeting, 12 which I was unable to attend. And basically, those 13 recommendations are not going to be further considered at 14 this point. In other words, if we go ahead and start 15 advising the commission on their options, our advice 16 regarding say, in trying to get where the -- I think 17 they're in here backwards.

18 ACMUI recommendation number 1 was encompass 19 all uses of ionizing radiation in medicine, conduct the 20 program uniformly. And then they said they would do an 21 alternative of D, but they wanted everything put in the 22 same pot. I presume that that has been rejected. I just 23 want to get that clear.

24 CHAIRMAN STITT: Well, my understanding, if 25 you look through a lot of the material that's here, all of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20E3701 (202) 234 4433

103 1 the comments that came back had a variety of options, and f e'} 2 certainly ours had some of those options. Now, what we're

'~#

3 dealing with -- yes, they've looked at that. I think what 4 we're reading between the lines from the staff that 5 presented this morning is that that is not going to be one 6 of the options that's strongly considered.

7 And that what we're going to deal with -- I 8 pulled out two particular pages that, one says consult 9 with the ACMUI, and that's what we need to be working on, 10 and then there are reactions to 7 and 12.

11 So they have taken what we sent them along 12 with a lot of other individual's groups, and have

/

,_s

\

13 processed and then sent back with some specific -- their

\ )

• s / 14 feelings and they want our reactions to that. That's how 15 I interpret it.

16 DR. CAMPER: I would agree. Certainly, the 17 Commission considered, in DSI #7 -- and again, the 18 Commission never comes out and says, yes we like the IOM 19 report or no, we don't like the IOM report, or yes, we 20 like the ACMUI recommendations or no, we don't. I mean, 21 you never get that type of emphatic clarification of their 22 reaction to your particular guidance, or for that matter, 23 to the IOM Report.

24 The " Impact" section of DSI #7 does I think,

,m

\

( ,)

i 25 the best job of spelling out the concerns that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 2000 # 3701 (202) 234-4433

104 1 Commission muet have had. But what the Commission does, 1

2 Dr. Nelp, is it takes the advice of this committee, it 3 takes the incoming comments, it takes the public  !

4 testimony, it takes all these things into consideration, j 1

5 And then ultimately, a decision has to be made. And -- l 6~ MEMBER NELP: I think it considers the advice 1

7 of this committee.

8 DR. CAMPER: It does consider it.

l 9 MEMBER NELP: It doesn't necessarily take the l 10 advice of the committee. I think that's the key, and f 1

11 that's the role of any advisory group, I would imagine.

12 DR. CAMPER: Well, that's true. It certainly 13 considers the advice of this committee, that's correct.

14 In some cases, I think I can demonstrate examples where Ol 15 the Commission has specifically and clearly accepted 16 recommendations --

17 MEMBER NELP: Oh, I don't mean that they 18 don't.

19 DR. CAMPER: Right, but yes, they did consider l

20 it and it was factored into the decision-making and yes, I 21 one certainly, reading between the lines can draw the 22 conclusion that the IOM Report was not the option of 23 choice, nor was the issue of the national approach of 24 uniformity was not the choice. And again, I think that 25 the " Impact" section does clarify to some degree, why that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

105 1 wasn't the option of choice.

f- s '

2 And I think at least in part -- and I don't

(

\- 3 want to speak for the Commission because I wasn't involved 4 in that decision process, it was theirs -- but I think 5 certainly the concerns expressed by the states and certain 6 organizations -- including the CRCPD and the organization 7 of agreement states, specific states and DHHS -- I'm sure 8 have played a factor in their decision.

9 And that was -- the IOM Report as written, was 10 not necessarily well received, or certainly totally 11 received, by a number of entities. So it's clear to me at 12 least, that that was a factor in their decision-making.

13 But that decision process was theirs.

O\

h 14 CHAIRMAN STITT: Let's break until ten-after, 15 which means we'll really be starting at a quarter-after.

16 And I want to jump into number 7 and everybody here is 17 obligated to become fervent, all right?

18 (Whereupon, the foregoing matter went off the 19 record at 11:02 a.m. and went back on the 20 record at 11:23 a.m.)

21 CHAIRMAN STITT: All right, committee, I gave 22 you five extra minutes and you took ten.

23 DR. CAMPER: We're back on the record.

24 CHAIRMAN STITT: Time keeps ticking away here A

( ) 25 and judging by the hallway discussions, a lot of people NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 734-4433

106 1 have a lot of things they want to say. One organizational 2 question is, how are we going to launch .into this, what do 3 we expect to get out of it?

4 One thing that I think we need to get is 5

people's opinions out in public, and obviously by speaking 6 here they're on the record, which turns into minutes and 7 then turns into what the Commissioners see.

8 The DSI 7 under slides, the Commission's 9 prelimina ry views were a combination of option 2 and 10 option 3. Now, that leaves -- there's options 1 through 4 11 or 1 through 5. Anything that's fair game for discussion, 12 and I think people have a variety of ideas.

13 So I can open up the committee for viewpoints.

14 I'm not sure if we're going to actually come up with some 15 sort of specific element to vote on. We'll see how it 16 goes, and this is not --

I'm running the meeting but this 17 is not my meeting of my opinions. We're here because 18 we're a group of professionals that all bring their unique l 1

19 ideas to the forefront. l 20 I'm going to ask Dennis to make some comments, l

' I 21 because I think he's been preparing something in his mind.

1 22 MEMBER SKANSON: I'll tell you my concern. I 23 don't personally have the confidence, and I don't think j 24 the regulated community in the medical area has the 25 confidence that the NRC, even with the strategic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 2344433

107 1 cassocmant plan, can make the necessary changes to ..

g-~g 2 effectively regulate the use of byproduct material in l t

\-- 3 medicine. '

1 4 And let me use a risk-informed approach as the 5 basis for that statement. Who is to determine the risk in I l

6 this risk assessment strategic planning? I think in the

]

7 past the community has brought to the NRC what its 1

8 consideration of the risks are. Certainly this group has j 9 made statements before, pointing out things that the NRC 10 desires to regulate is not all that risky. i l

11 Yet those risk assessments that come from the l l

12 medical community haven't been listened to very well by 1

-, 13 the NRC, and what's to say that the NRC in the future is s_s 14 going to pay attention to the risk assessments that come l

15 from the regulated community.

1 16 This whole issue of performance-based 17 regulation, again, another informed risk we attempted to i

18 set out to develop performance-based approach to the j 19 quality management rule. That fundamentally has turned i

20 into a very prescriptive approach to the quality l 21 management rule. A same question: what's to prevent i

22 future performance-based approaches from becoming very 23 prescriptive? Certainly, that hasn't been what we've seen 24 in the past with the NRC.

25 I find it very interesting, for example, in G

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

108 1 ths DSI #12, option 1, which is, continue current process, 2 and it says that the scope of the activities is determined 3

by consideration of industry demand, safety benefit, ease 4 of implementation, and available resources.

5 I doubt seriously if that is the current 6 approach; it's certainly not the approach we seem to 7 develop the regulations in this committee. We've i

8 witnessed the yo-yo approach as the principle approach to 9 developing regulations.

10 So as an overall concern -- I mean, I see you 11 setting out on a strategic assessment -- a strategic plan 12 -- but I'm just not confident that we're going to see the 13 changes. I mean, it all looks very good in words, but 14 what's really going to make the paradigm shift in the NRC 9ll l 15 that needs to happen to make these things work with the 16 regulated community?

17 CHAIRMAN STITT: He's looking at you as if 18 he's expecting -- are you expecting a comment or are you 19 just trying to lay it in -- lap?

20 MEMBER SWANSON: Maybe it's just an overall 21 question and concern.

22 CHAIRMAN STITT: Well, and the Commissioners 23 got the idea from Dr. paperiello. They have different 24 feelings depending on the makeup of the group. So we may 25 begin with a different group at this point. Naomi, are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 2J005-3701 (202) 234-4433

- . _ . - - - _ . . -- -- = . .

109 1 you looking --

, -~g 2 DR. ALAZRAKI: res. I couldn't agree more

( 6

\~ / 3 with some of the comments that Dennis made. I think the i

4 history of the regulatory relationship between the NRC and i

5 the practice of medicine has been such a troubled and -- j 6 such a poor history, really, for many reasons.

7 Primary, I think, in amongst those reasons is q 8 that the Commission and the NRC itself did not have 9 amongst them, real representatives of the community which 10 they were regulating, and they regulated in a vacuum in 11 the sense that they didn't really appreciate what the 12 practice of medicine and the medical community -- how it 13 operated and what it's real concerns were.

_, 14 And I still see some of that, to a lesser 1 J

l 15 extent, certainly, than previously, but still there is l

l l

j 16 some of that, particularly evident with this DSI 12 where 17 the language is so foreign to medicine and to medical 18 practice.

19 I, you know, in line with some of the things 1

20 that Dennis said about risk, I mean, I think we have to 21 look at the IOM Report and act on some of the things that 22 are written there and clearly, there has to be some 23 threshold for below some risk, somehow to be defined, 24 regulations is not necessary and not warranted.

I 25 So just to sum up, again, the NRC to be in NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

110 1

touch with the m: dical community and this DSI 12 certainly 2 speak for that. And number 2, to really look carefully at 3

that IOM, what IOM said, take it apart a little bit and l

4 incorporate it into whatever proposed new posture NRL is 5 going to take.

6 CHAIRMAN STITT: The DSI 7 has five options 7

and accompanying that the Commissioners are focusing on 8 option 2 and option 3.

I'd like to direct the committee 9 to make comments specifically relating to DSI 7 so we can 10 get started there. Let's start with John and then go to 11 Jeff.

12 MEMBER GRAHAM:: As one of the newer members 13 of this committee, I have over the last couple of years, 14 heard a number of comments concerning the reaction of the 15 Nuclear Regulatory Commissioner or Commissioners to advice 16 from this group.and the potential for it having been 17 ignored. I've also -- I guess I represent an attempt to 18 broaden the representation of this committee.

19 I share your concern about DSI 12. If I were 20 going to teach an advanced seminar in Government newspeak 21 I'd probably use it as part of my course material. I 22 thought it was enlightening that it was a Ph.D. that was 23 playing out that he had read it several times and still 24 couldn't comprebend it.

25 But I think the opportunity we have, if you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20N701 (202) 234 4433

111 1 accum:3 that DSI 12 in very complicated but fundamentally (

A 2 comes down to doing a risk determination, making 3 recommendations on where that risk occurs; if you further 4 assume that this group now has the medical representation l t

5 to give a very well-informed recommendation on where that '

6~ risk occurs, there's at least an opportunity that we l

7 simply it -- and I'm speaking as a layman -- that l 8 diagnostic use of isotopes is a low-risk activity and that 5

9 certain specific therapeutic use of isotopes constitutes a l 10 higher risk activity, and that therefore the former is 11 essentially outside major regulation and the latter is i 12 where this group has to articulate exactly what the NRC

. l

, .s 13 should be involved in.

/ \ l

. v 14 And I think if you read the impact statement

! 15 on option 3, it speaks to the fact there's an opportunity i l 16 to increase the efficiency of this organization, to reduce 17 the costs, to reduce the number of staff required, which 2 18 is consistent with the general tone of this nation in 19 recent years in reducing over-regulation at every level.

20 So I think we could spend a lot of time 21 working on the past but I would throw that out as a

22 layman's first approach. Do away with the one in 23 diagnostic because it appears there's a very low risk; 24 focus on the latter. And keep that recommendation as 25 simple as we can, because if we start talking about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS

! 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

112 1 specific iscuss that havn b:en enforcement problems with 2 the low-level diagnostic isotopes in the past, we're 3 sliding down a slippery slope that implies that there's 4 still a need for that kind of regulation and enforcement.

5 CRAIRMAN STITT: Let me ask a question, then 6 keep going with our discussion, because I think that's the 7 important thing that we have to offer. Is the risk -- are 8 we talking about the public here, are we talking about a 9 particular individual who's going to be receiving an 10 isotope? I'm going to leave it at that. Jeffrey?

11 MEMBER WILLIAMSON: Well, I just wanted to 12 make a brief suggestion, maybe regarding something to 13 perhaps help structure our discussions. In the last 14 couple of meetings it seemed that there were a fairly <

15 well-defined set of consensus principles that were sort of 16 developed in this group that kind of guided our -- you 17 know, the sort of consensus reaction to the IOM Report.

18 Many of them overlapped but were not identical 19 to the Institute of Medicine Report. It might be useful 20 to sort of look at the options 1, 2, 3, 4, 5 -- and 21 especially the favored -- what is evidently the favored 22 option from the point of view of those principles.

23 I'll say one that concerns me is the fact 24 that, you know, the agency -- perhaps it's because the 25 Commissioners decided to do it that way or perhaps because NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

113 1 there's so many political factors outside of their control

-^g 2- -- has evidently abandoned the idea of trying to promote a b 3 framework that' applies to all sources of ionizing i

4 radiation and is poised, it seems to me, to rewrite Part 5 35 with the intent to keep regulations regarding medical 6 use of isotopes on the books for therapeutic procedures; 7 but yet, you know, on page 15 they say, the safety issues 8 are not compelling to warrant, you know, looking into a 9 legislative solution to put all sources of ionizing

-10 radiation under one umbrella.

11 So one has to ask what's so special about the 12 medical use of cobalt-60 teletherapy, for example, 13 compared to linear accelerators. That in the case of l'

(N, ,.

k/m 14 linear accelerators there's no compelling safety issue; 15 with cobalt-60 there are.

16 But as you can hear, I'm sort of concerned 17 about this following through and staying in conformance 18 with what appears to be sort of an accident of history, 19 the way the Atomic Energy Act was written, and that's 20 going to frame our whole discussion.

21 CHAIRMAN STITT: And I think that we're asking 22 questions that are not necessarily somebody that we're 23 expecting to answer back. For some of them there is no 24 specific answer and your comment about a -- this is based (O) 25 in history -- the report from the Institute of Medicine NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

114 j 1 did not have a lot of history in it.

2 It had a -- the first chapter was, I thought a 3 good chapter on risk. Some of the data that's out there i 4 was reported in that chapter. But certainly there's 5 history of the NRC and of the ACMUI that we are -- that's-6- what we have to work with. You don't have to like it, but i

7 it is the background.

l 8 So again, let's focus on 7; we keep moving to 9 12 because obviously, they're interrelated, and because  ;

10 the Commission is liking at this point to focus on 2 and 3 11 does not mean that we can't discuss everything, and that's 12 why I wanted to leave it open so everybody can have an 13 opinion heard.

l 14 And one of my questions to the committee is, 15 do we want to end up with something as straightforward as 16 we had at our February meeting where we had -- in fact, l i

17 Larry went through that -- the ACMUI had some specific 18 recommendations. So if we can get to that, certainly that 19 would be fine.

20 I do want to make sure everybody has a chance 21 for their opinions to be heard.

22 MEMBER NELP: But Judith, didn't Larry tell us 23 in so many words that we gave them that advice and they 24 listened to it and considered it, but did not accept it?

25 CHAIRMAN STITT: I think we've had --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

_ _. - - .- . - . . . - . .-- a._..

l 115 1 MEMBER NELP: So I'm vary reticent to go back  !

i fs

\

2 and say, let's.give them the same advice again when

\-) 3 they've said, we don't want that advice, we want you to 4 look at, you know. I mean, can you help us with options 2 5 and 3?

I '

6 DR. CAMPER: Right. Well, that's why I i

7 commented earlier in my comments -- it seems to me that there are two buckets in which you can put your comments.

8 9 You can comment about, you know, the strategic assessment  !

10 initiative at large; you can comment about DSI 7 and 12 at i i

11 large. And then the other bucket is, the idea that again, 12 if we assume that the Commission will continue in its

-' l 13 preliminary finding -- which is a preference for options 2 7..

.- 14 and 3 -- your reactions to those options.

15 Now, you can revisit the IOM Report as much as 16 you want. I mean, you have X number of hours to do that i

17 and you can do that. But I think in doing that, again, I l 4

18 think the most productive thing you'll be able to do is 19 to, again, try to identify your comments into those two

]

5 20 buckets. And I would clearly bifurcate my process.

21 Now, if you want to develop underlying j 22 standards for consideration, you can do that too. But I 23 think you'll have the most productivity -- I think that's 24 what Judith is trying to do, to focus you on DSI #7.

O 25 But let me just say this, again. The

\

%)

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

116 1

Commission certainly did consider the views, and I believe 2

it is fair to say and accurate to say that the Commission 3 will continue to consider your reviews. I mean, decisions 4 have to be made; many factors have to go into decision-5 making. All considerations are part of that process, but C-ultimate decisions have to be made.

7 Some of them you like; some of them you don't.

8 Some of them you agree with totally; some of them you 9 don't. And so forth and so on. But I think it's --

10 certainly, getting back to Dennis' comments -- certainly 11 it's clear, there's no question in my mind, I have a 12 direction. I mean, already I have a direction, from my 13 management and from the Commission in its preliminary 14 finding.

15 Consider -- I mean, I don't think the 16 Commission can be more explicit, to me as a manager. Get 17 guidance on low-risk medical activities; do a revision to 18 Part 35; get the ACMUI and put on these various things. I 19 mean, that's an order as far as I'm concerned.

20 So my point is, I certainly sensed that 21 there's a different approach in mind that has historically 22 gone on. I recognize your concerns; I have those concerns 23 myself as a member of the regulating community. I 24 understand. But I certainly see clear, clear direction 25 from the Commission, and it's my charge as a manager, to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

117 1 carry it out.

p 2 CHAIRMAN STITT: Lou, do you want to make 3 comments?

4 MEMBER WAGNER: In regard to direction-setting 5 issue paper number 7, first of all, as my position is 6 concerned, option 1 is absolutely unacceptable if it was 7 enforced by the NRC. They have very limited expertise in 8 the medical arena in the first place, and then to also l

9 throw in there x-ray and everything else, I think would be l l

10 totally incorrect. So option 1 is not an option as far as )

11 I'm concerned.

12 Continue ongoing program with improvements. I i 13 hate that word " continue" because the word " continue" says V 14 we're going to do things in the same way as we've done in 15 the past, and I'd like to see that word " continue" just 16 eliminated. I. don't think option 2 is a viable option.

17 DR. CAMPER: May I stimulate you with a 18 question as you go through that?

19 MEMBER WAGNER: Yes.

20 DR. CAMPER: I thought your first comment was 21 very interesting and maybe will help the discussion. You l 22 say option 1 is simply not viable. But option 1 would be, 23 perhaps, one of the best vehicles for achieving national l 24 uniformity.

D 25 MEMBER WAGNER: That's absolutely correct, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W. .

(202) l!34-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433 l l

118 1 I think the ACMUI's recomm:ndation was to have option 1 2 but not under the NRC. That's the point. It should be 1

3 under a health -- a Federal agency more concerned with the 1

4 health issues of people. l l

5 DR. CAMPER: Right. '

6- MEMBER WILLIAMSON: I would like to just I 7 refrain my comment to be directed toward DSI 7, I guess by 8 saying I don't like option 1, and I'm objecting, you know, l 9 to the fact that -- and would respectfully suggest that 10 this committee reiterate its previous recommendation that 11 there is a need for uniformity and that it emphatically 1

12 should not be under the leadership of this agency. An i 13 option zero, if you will.

9l I mean, that's an objecting to l

14 the list of objections being so tightly circumscribed.

15 CHAIRMAN STITT: Does this group want, by the 16 end of the day, to have something that we're going to be 17 able to vote on, point-by-point?

1 18 MEMBER WAGNER: I think we ought to have the 19 recommendations. I mean, I don't want to speak for the 20 committee, but my opinion is, we should have 21 recommendations that we can forward to Don Cool who can 22 take them on to the Commission for us.

23 CHAIRMAN STITT: All right. So then, let me -

24 - we're going to go back to 1, and I'm not going to ask 25 for people to necessarily vote on them point by point by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

119 1 point, but I think we need to have some strong statement 4 (

f-'s 2 that comes from -- and we are, as Larry read to us, an

\' -

3 advisory committee. If we have a consensus we vote on it; 4

if there's an outlying opinion, no matter what the opinion 5 is, that needs to be set up and framed so that that is 6 also reflected.

7 I think we should point by point then, as we 8 finish our meeting, this segment of the meeting by the end 9 of this-day -- or by 3 o' clock -- at least have some 10 statements that we're willing to make on all these 11 options.

12 MEMBER NELP: Would it shortcut and focus if I 13 made a motion that we reiterate; that we clearly wish to

\ms 14 emphasize that we give the same consensus advice that we 15 gave the last time around; that would be our preferred 16 method of operation or preferred advice? They heard it 17 once. If I made this motion I would think it would carry.

18 Then we can go on from there. That takes care of trying 19 to reformat something else that you spend hours and hours 20 and hours formatting.

21 CHAIRMAN STITT: Well then, we could all go 22 home early. But I'm not sure --

23 MEMBER NELP: No, then we could say, that 24 option not being viable, then we could go on with the rest (g j 25 of the business.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

120 1 MEMBER BROWN: I would second such a motion.

2 CHAIRMAN STITT: Then we need to pull out --

3 somebody want to, while I'm talking --

4 MEMBER NELP: In other words, I --

5 CHAIRMAN STITT: -- pull out the ACMUI 6~ recommendation.

7 MEMBER NELP: I was looking at the abbreviated 8 --

9 MEMBER BROWN: They're in the minutes, far as 10 I --

11 CHAIRMAN STITT: They're bullet points. In 12 fact, Larry presented them; they're probably with the 13 slides.

14 MEMBER WAGNER: Well, I think they were 15 covered in Larry's talk, and all we have to do is refer to 16 --

17 CHAIRMAN STITT: I just want to make sure we 18 have them in front of us.

)

19 MEMBER NELP: Or if somebody made the motion -

20 - since I was not here at that previous meeting, maybe 21 someone else would feel comfortable, or more comfortable, l

22 making the motion.

23 MEMBER WAGNER: Well, I think it has an 24 interesting impact coming from somebody who wasn't here at 25 that time.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

121 1 CHAIRMAN STITT: Well, it is interesting. I 7' 2 want to keep discussing that. So as to review ACMUI v 3 recommendations when we were together in February, the 4 first point was substantive Federal oversight. Now, I'm 5 looking for some comments regarding option 1. That is, 6' what were our comments about the broad monitoring 7 withdrawal --

8 MEMBER WAGNER: I think it's Alternative D 9 under the ACMUI recommendations. We have substantive 10 Federal oversight, mechanism to ensure compliance with the 11 states and users, such as linkage to Medicare -

12 reimbursement, that recognizes the problem uniformly,

,_s 13 state regulation programs.

( \

k2 s 14 The whole idea was DHHS, they,-- the next 15 page, the third bullet -- state programs monitored by a 1

16 Federal agency; the Federal agency should be an agency 17 with overall medical perspective; Department of Health and 18 Human Services was the option we recommended.

19 But I think the emphasis was on the fact that  !

20 it must be a Federal agency with an overall medical 21 perspective; that was the emphasis.

22 CHAIRMAN STITT: And then there's -- on the 1

23 following page, encompass all uses of ionizing radiation 24 in medicine.

t

() 25 MEMBER WAGNER: That is correct. But those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20006-3701 (202) 2344433

122 1 nro linkr.d; they should not be separated, and I think it 2 would be incorrect for the NRC to interpret a takeover off 3 all types of radiation producing devices as inappropriate 4 as far as the ACMUI recommendations are concerned.

5 MEMBER WILLIAMSON: There's another set of 6 things that may be useful. On page 7 of our February 7 minutes there are the principles I was alluding to, 1 8 through 5, which are a little more general formulations of 9 the philosophy of the community.

10 CHAIRMAN STITT: So the sense that I'm getting 11 is the committee wants to -- I mean, certainly in the 12 format of the options 1 through 5, the things that we 13 talked about in February all come up -- although we may 14 rank ,them quite a bit differently. Where are you talking 9 15 about, Jeff? Page?

16 MEMBER WILLIAMSON: Page 7 of the February 17 minutes.

18 CHAIRMAN STITT: Okay.

19 MEMBER WILLIAMSON: Following the paragraph 20 beginning, "ACMUI deliberations".

21 CHAIRMAN STITT: Right.

22 MFMBER WILLIAMSON: It's sort of -- I was very 23 --

24 MEMBER NELP: Page 9 really gives the 25 consensus recommendations. In the minutes of that meeting '

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

. . . .. . _ _ _ _ __ . - ~ _ _ . _ _ __ ._ .

i

123 i 1 it givos

rebuild, Federal mandates, state' programs should

2. be monitored, encompass all uses under one umbrella, etc.

3 Would you agree? l 4 CHAIRMAN STITT: Yes, let's focus on page 9, 5 because it says, the AC UI reached a consensus as a result )

6- of committee deliberations concerning the following 7 actions. So I think that probably lays in front of us, 1 J

8 what we did in February.

9 ,Do you folks want to discuss these in light of i 10 what we're lookirg at today? That's what you've been I

11 telling me.

12 MEMBER NELP: I would move --

7 13 CHAIRMAN STITT: Lou, you're shaking your

'{

V 14 head.

15 MEMBER WAGNER: I don't want to discuss ic.

16 CHAIRMAN STITT: You want to move it and vote 17 on it?

18 MEMBER WAGNER: I think we ought to just -- on 19 his motion.

20 CHAIRMAN STITT: Okay.

21 MEMBER NELP: May I make a motion?

22 CHAIRMAN STITT: You may. You've tried 23 several times; I'll now let you.

24 MEMBER NELP: Well, I would happy if someone

's 25 else -- I would move that this committee send a message to u

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2344433

124 i

i the Commincionare of the National R;gulatory Commincion 2 that our first choice, after redeliberations and thinking, I 3 would be to reiterate the choices that we made in February 4 of 1996, are still our first choices; and those choices 5 are such that we communicated as indicated on page 9 of ,

1 6- the minutes of the February 21/22 meeting.

7 CHAIRMAN STITT: Okay, that's a motion.

l 8 MEMBER BROWN: I would second that motion. I 9 CHAIRMAN STITT: All right. Time for 10 discussion.

1 11 MS. LIPOTI: Since I can't vote on the motion, 12 'I would like to add some discussion for your consideration 13 as you vote on the motion. One of the points that you 14 make here is, Federally mandate that states administer the 15 medical regulatory use program with appropriate incentives 16 to encourage states to comply.

17 Currently there are 29 agreement states and 21 18 non-agreement states, with four states which have 19 expressed the interest in becoming agreement states. I 20 would ask that you take into consideration those 21 non-21 agreement states. What exactly is going to happen if the 22 Nuclear Regulatory Commission is not the body that 23 oversees?

24 You're talking about changing the oversight 25 Federal agency from NRC to DHHS; which has regional NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

l 125 1 offices; which has innpectoro who are trained in I

s 2 mammography; who have training in looking at new x-ray 1

\ ',\

3 machines to see if they comply with the FDA standards for 4 construction of x-ray machines, but not x-ray machines in 5 use. Not use.

6- You have states that have varying expertise in 7 the area of medical uses of isotopes, as well as varying 8 budgets in terms of how much resources they can put into 9 the oversight of medical uses of isotopes.

10 I think you have to be very, very careful if 11 there isn't some replacement for what now happens at the 12 NRC regional offices of inspection of facilities that are

,_, 13 in non-agreement states. Are you saying in your motion

\m-) 14 that you would not regulate these, and if a state did not 15 pick it up, that FDA should increase their budget and 16 staff to perform that service to protect the public? i 17 MEMBER NELP: I'd like to respond, if I may?

18 We're not proposing that we throw the baby out with the I 19 bath water. We have all kinds of expertise; we have all 20 kinds of past experiences. So we can take the strengths 21 of anything that we have within the NRC and transpose them 22 to a more broadly applicable Federal agency.

23 For instance, if I were running a company, I 24 might say, I just heard that three percent of the budget

( ) 25 or three percent of the FTEs of the NRC are involved in NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20006 3701 (202) 234 4433

126 1 this process.

I might allocate that amount of money to 2

the same process but put it under a different umbrella.

3 I had a question for you. I would presume if 4

90 percent of the regulation of radioactive materials in 5 radiation in medicine plus a fair amount of the 6 radioactive materials of non-byproduct material, are 7

carried out in the 50 states, do those 50 states have an 8

organization of state radiation safety offices that are in 9 parallel to the agreement states? And do the agreement 10 states meet with all 50 states and share --

11 MS. LIPOTI: Yes.

12 MEMBER NELP: -- share experiences, etc.?

13 MS. LIPOTI: Yes. The organization is the 14 Conference of Radiation Control Program Directors which 15 was referred to in the IOM study.

16 MEMBER NELP: And that Conference of Radiation 17 Control Program Directors, how do they assess their 18 effectiveness in controlling the safety of the use of 90 19 percent of the radiation that's used in medicine?

20 MS. LIPOTI: There is no organized measure of 21 effectiveness of state regulation --

22 MEMBER NELP: What is their gestalt? How do 23 they feel that they're doing? Are they in a panic state 24 or are they in a state of satisfaction?

25 MS. LIPOTI: There are varying states of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344 433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

127 1 catisfaction in varying states.

2 MEMBER NELP: But I mean, are there 3 catastrophes or are there -- I don't know of any if there 1

4 are, so I'm uninformed.

5 MS. LIPOTI: Wyoming, for instance, has no E radiation control program; the entire state of Wyoming. l 7 Nothing. Does that mean that there are no incidents of 8 overexposure?  !

1 9 There's no reporting, so I don't know.

10 MEMBER NELP: You're not aware of it? The 11 reason I asked that is, is it true that if we ask these l l

12 states to take on the NRC burden, it would be increasing 13 their work load by 10%, or would they be increasing their

[

14 work load by some other fraction?

15 MS. LIPOTI: That's a very good question. And 16 what I use as my gauge to answer that is the NRC's 17 information digest where it talks about the number of 18 licensees that are in these various states. As you know, 19 if the four states that have expressed interest in 20 becoming agreement states do, the NRC will be down to 21 regulating about 4,000 licensees with some 20,000 in the 22 agreement states.

23 So most of the non-agreement states are the 24 lower population states.

25 MEMBER NELP: So it would -- those are my NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2N WASHINGTON, D.C. 200054701 (202) 2M

128 1 commento. I don't -- my big comment is, I'm not concerned 2 that we're going to destroy the regulatory knowledge that 3 we have by transferring it from point A to point B.

4 CHAIRMAN STITT: Larry has a comment, and then 5 --

6 MR. CAMPER: A comment of discussion as you 7 consider your motion. You -- and it may or may not 8 ultimately impact your deliberations, but you need to be 9 aware of it. You now have a piece of information -- you 10 have two pieces of very important information available to 11 you now that you didn't have in February with regards to 12 your previous position.

13 Number one, you now know that the Secretary of 14 the Department of Health and Human Services has responded 15 that DHHS does not believe that IOM made a compelling 16 reason in its report for DHHS to assume this 17 responsibility; nor does the Secretary believe that the 18 Congress would allocate funds necessary for DHHS to assume 19 this responsibility.

20 The other key factor that you now know that 21 you didn't know at that time is that a number of states 22 responded and a number of organizations representing the 23 states responded that they felt that this would be viewed 24 as an unfunded federal mandate; and that in some cases, in 25 the extreme case, as Dr. Lipoti pointed out, the State of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20 6 3701 (202) 23M

~

\,

129 j 1 Wyoming, which hen no radiation control program at this i

7- g 2 point in time.

1 l;

3 And so I point those out to you because those,  !

4 I think, are vital pieces of information that you might i

5 want to consider in reevaluating if your posture is '

6- identical to what it was in February.

7 CHAIRMAN STITT: Lou?

8 MEMBER NELP: But we know -- we wish to l

] 9 emphasize that this recommendation is preferred. No j 10 recommendation is going to go into techr#cil detail to 3  !

i 11 solve all the problems. This is a recommended overview  !

d 12 format. Whether Wyoming has a regulatory process or not 13 is not a very risky issue, because Wyoming doesn't l (m,/ 14 practice much medicine; and they probably don't practice is much radiation medicine in relationship to the big i

16 picture.

4 17 That is a separate, small issue. If a state 18 already has a radiation safety program and they're not an 19 agreement state, I'm trying to say they could deal with --

20 they're dealing with the whole issue now whether they have 21 an agreement or whether they don't have an agreement.

22 CHAIRMAN STITT: Lou, you've got some 23 comments?

24 MEMBER WAGNER: I'd like to address Jill's f'J 25 comments because I think they're well founded. And I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

130 1 think tharc's coma micunderstanding from -- at least from 2 my point of view regarding what the discussions of the 3 ACMUI were last meeting.

4 As far as the statement regarding the states 5 to comply and administer the programs, the idea there and 6 what brought that recommendation around was the idea of 7 states -- recognizing state's right to make up their own 8 regulations. And if the states made up regulations that 9 were inferior to the federal regulations, then there would 10 be a problem.

11 And that's what this was meant to address. As 12 far as the issue with the smaller states that don't have 13 the resources, the thoughts were that that would be 14 administered much like the NRC currently administers its 15 agreement state program. And that is, there would be 16 federal assistance for those states in order to make the 17 inspections and make the administration possible.

18 And I think that was all the discussion of the 19 ACMUI was not to throw the onus on to states that couldn't 20 afford it or didn't have the resources. And that was the 21 purpose and intent there.

22 The mechanisms that we came up with were 23 mechanisms to try to give incentives to meet the federal 24 regulations level, and not to water it down and make it 25 worse. That was the idea.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200( 5 3701 (202) 2 % 4433

131 1 CHAIRMAN STITT: Judith has a comment, and

/"'N 2 then Naomi.

3 MEMBER BROWN: Okay, I wanted to address 4 Jill's comment too. I wanted to make it clear that the 5 reason I seconded the motion was not that I loved every 6 one of our recommendations, but that it represented a lot 7 of deliberation; and it seemed to be the best thinking and l 8 the only consensus we really could reach as a group last 9 time. ,

i 10 And I just looked around as a practical 11 matter, didn't see any new members that were eligible to 12 form a new consensus with us and said I don't think

,-,.s 13 anything's going to change by us spending another four

\v)

(

14 hours discussing this same issue. And the two things that 1

i 15 Larry brought up don't seem worthy of four hours either.

16 I don't know that we're going to just go knock I 17 on another agency door and say will you take it over. So, 18 for me, it was a practical consideration to resubmit the 19 results of our deliberations the first time.

20 CHAIRMAN STITT: Naomi?

21 DR. ALAZRAKI: In regard to the comments about 22 the small states, there are precedents for states joining 23 together for one reason or another, like the compact --

24 the waste compacts and all. And there's on reason why the

( 25 small states couldn't work together in terms of some sort NEAL R. GROSS COURT REPORTERS AND TRANSCRBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 2M

132 l

1 of union for purposes of regulation.

2 The other point is that in the ACMUI agreement 3 on page nine, the first one, rebuild the medical use 4

1 regulatory program without using the current regulatory i

1 5 program as a starting point, the objectives of regulations 6- must be reassessed. And I think this is key because in 7 line with the IOM report, the bottom line -- I think the 1

8 real message is that we are currently, as currently under 9 the NRC program, regulating where we need not regulate; 10 regulating where the risks do not warrant that kind of 11 regulation.

12 And so the programs that actually -- to my 13 mind, that would need to be undertaken by states would be 1

14 much smaller in scope than what currently NRC does. And 15 so -- and I think that states did not -- at least I think 16 the states did not really understand that, and maybe it 17 wasn't made clear enough in the IOM report, but I think 18 that was the intent.

19 And so, I view it as really manageable -- more 20 manageable than it seems the perceptions are in the 21 general move to down regulate rather than up regulate --

22 but down regulate.

23 CHAIRMAN STITT: Which is in keeping with 24 option number three regarding low risk versus high risk.

25 Let me pull two points together and ask for comments from NE>d. R. GROSS COURT REPORTERS AND TRANSCR13ERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WA3HINGTON, D.C. 20005 3701 (202) 234-4433

133 i

1 tha group. Back to our recommendations from February, the I

<- 2 first parag7;aph that Naomi just read: that is, we were  !

(N)

'_ 3 talking about rebuilding regulatory program -- and then 4 the next to last, " encompassing all uses of isotopes."

5 But we also threw in the caveat that this 6 would be a different agency, and we had recommended 7 Department of Health and Human Services. And I think that 8 if we just adjourn ourselves today by saying we like what  !

l 9 we said the first time, we're going to-vote and go home, j l

10 we are not paying attention to things that have' happened 11 in the meantime.

12 And if Donna Shalala says she doesn't want 13 this, I don't think we can wish it differently. So I 14 think we have to be careful in just reaffirming our 15 previous votes. So I'm going to throw that out there and 16 go down this limb of the table.

17 Swanson?

18 MEMBER SWANSON: I would agree with that. You 19 know, maybe we need to reconsider whether DHHS is the 20 right agency in view of the legislative concerns and the 21 changes. I really don't have a major problem with the l 22 regulation of the use of -- medical use of radiation 23 staying under the NRC, but with a different model under 24 the NRC.

C

, i, 25 For example, I can envision a formation of a N

NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 20006-3701 (202) 23H433

134 1 board under thn NRC that would develop these regulations 2 as an official board of the ND" d eveloping these 3 regulations. Similar to risory group like this, but 4 not be an advisory group any more. This is the board that 5 develops these regulations that are then enforced and put 6 into operation by the states.

7 And if we're thinking outside the box, that's 8 another approach that I think that we ought -- which would 9 basically take into account everything that we've 10 recommended today, but put it in a slightly different 11 model.

12 CHAIRMAN STITT: I'm going to keep going down 13 this side.

14 Go ahead, Theresa.

15 MEMBER WALKUP: The commissioner gave us five 16 options to consider, is what I understand. And I think we 17 all agree that we need to -- we agree on what we agreed on 18 before. But I'm wondering if we should not put that under 19 one of these options to present to them. For example, 20 perhaps four.

21 CHAIRMAN STITT: I think a lot of the things 22 that we brought up as our recommendations in February have 23 crossed many of the options, if I read that correctly. We 24 had grouped them somewhat differently, and we had also 25 predicated one being connected with some of the others.

NFJAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

135 1 Any other comments on how that would work?

1 o 2 Jeff?

3 MEMBER WILLIAMSON: Well, I was just going to 4 say I think that this could -- if we have two buckets 5 we're putting our comments in, our affirmation of the 1 6 previous position would amount to saying we don't like --

7 you know, we find all of the options presented in DSI 7 to ,

8 be inferior to the one we came up with.

9 And I think then I guess our issue really --

10 if we still agree with that philosophy, then the issue, 11 you know, becomes do we lose credibility or something by 12 continuing to beat our heads against a stone wall. 'I 13 guess that's the kind of argument.-- you know, practical O

(j 14 argument that might be made against that.

15 That's really all I wanted to say is that I 16 think it's not incompatible to pass this motion and then 17 go on with a more detailed assessment of the options as 18 written.

l l

19 CHAIRMAN STITT: Okay, I'm going to go -- I'm 20 going to go 12:15 because we can all eat here. Besides, 21 it's cold and snowy and icky out, and we don't want to get 22 wet.

23 MEMBER NELP: Can I just refine my comments?

i 24 CHAIRMAN STITT: Let me have Lou's comment (D 25 first.

(]

NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

136 1 MEMBER WAGNER: I just wanted to comment that i

2 we have to read what's stated here. It says l

3 recommendation that this be the Department of Health and l

4 Human Services. That was our recommendation. We didn't l

5 say it had to be. We said it was a recommendation. I 6 mean, this is -- the whole idea was we understood the fact

{

l 7 that this is going to require congressional action to l l

8 occur.

l 9 So this really wasn't a recommendation 10 necessarily to the Commission. It was a recommendation to 11 Congress. And say no, this thing -- this has to revamped 12 and revised. We knew that when we went into it. And we 13 also had a pretty good idea of how things would go because 14 of all the political forces that are moving things. 1 15 So this is a recommendation. And I think it 16 should be made clear that that's a recommendation about 17 the Department of Health and Human Services, and it is not 18 a requirement, and I don't see that it should lose any 19 credibility, even though we still know that the Department 20 of Health and Human Services has said that they don't 21 want.

22 CHAIRMAN STITT: In that same light, the 23 comment we just heard from Dennis, he had a recommendation 24 that actually was akin to leaving the business in the NRC.

25 But again, referring to his thinking outside the box, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

137 1 looking at a different mechanism, is this group wanting to 2 vote on the motion that's on-the floor and then go on with 3 additional comments?

4 It could still be about the motion. Or , do 5 you want to keep going with.the discussion into the 6 afternoon? At some point, we have to vote on the motion 7 on the floor.

4 t

8 MEMBER NELP

May I make 4 comment just to 9 help you? My purpose of making this motion was to say we 10 really feel the same way that we felt before; but, if you i

11 want us to consider these other things, we will. And just I

12 get it -- and we could go and spend another week on the 1

13 details in these recommendations, but I think for the i (~)

V 14 purposes of emphasis, all I wanted to say -- look, 15 commissioners, this is really how we feel.

4 16 CHAIRMAN STITT: All right, and your point's l 17 i

very well taken.

18 MEMBER NELP

And now, if you want us to look 4

19 at these other options, they're our second preference; but I

20 let's get the motion either passed or not passed, and then 21 we'll go on with the work --

4 22 CHAIRMAN STITT: All right, so now this limb i

23 of the table gets to make comments, and then we're going 24 to deal with the motion.

25 MEMBER FLYNN: For discussion purposes, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 236 4433

138 1 inctand of DHHS, I don't c a why we just can't -- instead 2 of being so prescriptive, just put a federal agency with a 3 health focus rather than a regulatory focus. And then you 4 can get away from DHHS where there's going to be some new 5 agency, where you're going to have branches of the NRC 6 combined with other branches of some other agency to form 7 some new agency.

8 You don't have to specifically name an agency.

9 It doesn't have to be an existing agency. So get away 10 from that. Because as soon as you become so prescriptive, 11 they can knock off the recommendation based on the fact 12 that you have named a specific agency.

13 MEMBER NELP: Would you like to amend the 14 motion?

15 MEMBER FLYNN: Just that it be a national 16 agency, either existing or newly formed, which has a 17 medical or health focus rather than a regulatory focus.

18 MEMBER WAGNER: I second that.

19 CHAIRMAN STITT: Now we've got an amendment.

20 Do we want to go through each point and start amending

' l 21 them, or do you just want to -- l l

l 22 MEMBER NELP: Let's just take -- l 23 CHAIRMAN STITT: Take where we were and then j 24 we can continue to go through the points with commentary. l 25 What do you folks want to do?

NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.c. 20005-3701 (202) 2344433

139 j 1 MEMBER NELP: I don't think we want to redo

,7g 2 the -- all the work that went into this. I'm doing it for 3 a matter of -- let's tell them this is how we really 4 think, whether it's perfect or -- you can take each 5 sentence, comma, and period and spend a lot of time, d

6- I don't --

I did not intend the motion for 7 that -- to reconstruct this. I thought it was constructed 8 very well.

9 CHAIRMAN STITT: But if we don't add any 10 commentary or anything new, I would expect the 11 commissioners to be fairly dismissive of us coming back 12 and saying we liked it the first time, thank you, good 13 bye.

O I h

( ,/ 14 MEMBER BROWN: I think we can reframe our 15 recommendations in accordance with their outline. But 16 what I would like to do is to not vary significantly from 17 our -- what we worked so hard to be a consensus.

18 CHAIRMAN STITT: What about -- and again, 19 we've got a motion that we're going to deal with; and then 20 we could come back and have a discussion of the points of 21 our February and what appears to be our current within the 22 framework of these options, plus their recommendations.

23 So that at least we have some commentary under -- showing 24 them, the world, the nation, that we have revisited all D; 25 the incoming information which has transpired since our CJ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

140 1 last m3 sting.

2 I'm getting some heads shaking. I think i l

3 people are getting hungry, and you're willing to agree to 4 anything at this point.

5 Now, I need Robert here for rules of orders.

6 We have a motion and we have a second that was relating to 7 our February work. But then we had an amendment that was 8 seconded.

I 9 MEMBER WAGNER: We have to vote on the )

I 10 amendment first.

11 CHAIRMAN STITT: All right. Does anybody have J 12 -- Torre, do you have the amendment to read to us? I 13 MEMBER GRAHAM: We didn't make it all the way l 14 down this side. 9l 15 CHAIRMAN STITT: Okay, you're right. This is l

16 an egalitarian society.

17 MEMBER GRAHAM: Madame Chairman, --

l 18 CHAIRMAN STITT: Go ahead, John.

i l

19 MEMBER GRAHAM: Having been at that meeting, 20 so -- having sat through that discussion, the fundamental 21 concern that I walked out of this meeting -- or that 22 meeting with, was that this group was advocating that we 23 had to rebuild the medical use regulatory program.

24 And again, just from my limited perspective, 25 all the other recommendations that we gave were simply our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. .

(202) 23 4 433 WASHINGTON, D.C. 200 5 3701 (202) 23 4 433

. - _ _ - . _ . . - - . . . . - . .. . .-- - . = . . - - -_

l 141 l 1 perceived need to flush out that recommandation with some

.-fs 2 specific ways that it could be approached. So there was a 3 discussion about let's throw everything in, because in an 4 ideal world, ionizing radiation sources all should be 5 covered by one agency.

6- But I didn't detect a compelling need to'say 7 that if nothing else happened -- if we didn't get that, we 8 didn't want any other change to occur. And so we're 1 9 getting feedback now that -- politically to go back and 10 try to pull all of those other forms of regulation, and 11 that a federal level isn't very realistic.

12 We've gotten feedback from the states -- if j t

13 you don't give us money, we don't want to take over doing O* 14 this. If you talk about 40 FTE's and we're going to

\

I 15 spread that out to the state level, that means we're going j 16 to allocate, in an ideal world, one FTE per state to do 17 this, which I don't know is realistic.

18 This group, I. thought, said we want to revise 19 the regulatory world. Option one, as the commissioners 20 have reframed it -- and frankly, I think we have to 21 evaluate that we're giving them a political opportunity to 22 amend, to have reviewed our recommendations, to receive 23 public comment, and then modify them.

I 24 So they addressed option one, which was cover '

i s

25 it all. And they're saying there are a lot of problems NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

142 l 1 with trying to cracto a larga cnough bureaucracy and get 2 it funded to do that. Option two is to continue the 3 program as is. And I think we've -- this committee, over 4 the years, has expressed a lot of concerns with continuing l 5 business as usual.

6' So I think they clearly -- the Commission 7 moved in its direction by saying in option three, we ought 8 to decease the oversight of low risk activities. Option  !

9 four is what gets into this whole issue in their 10 documentation in DSI 7 of problems at the state level.

11 They tried to get completely out of the business. And 12 option five is they ought to get out of material 13 regulation completely, and I don't think this group was 14 advocating that and shouldn't.

15 So I think we have an -- yes, I was part of 16 the discussion originally. I voted on the consensus. I 17 think it was -- and at the time, don't forget, the ACMUI's 18 recommendation and consensus was having been asked to 19 specifically respond to the IOM report.

20 We're not being asked to respond to the IOM 21 report today. I think that's old history. I think it was 22 flawed. Now we have an opportunity to react to the DSI 7 23 where we have Commission's preliminary views in front of 24 us. And I would advocate that we ought to focus in on 25 redefining the regulation of medical use, decrease NEAL R. GROSS COURT REPORTERS AND TWWSCRIBERS 1323 RHoDE ISLAND Ad.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

143 1 ovorcight.

2 And that this group has more medical

\

f)N 3 perspective than any other group ever will to define that 4 low risk means all of those diagnostic activities; high 5 risk is-whatever this group defines medically it ought'to 6 be; and that we keep it as simple as that-.

7 MEMBER NELP: I concur. I just wanted -- if 8 you don't feel that this was your best shot, and this 9 would be the most -- then we can go on with the work l

10 you're discussing.

l 11 MEMBER WILLIAMSON: Could I make --

I 12 CHAIRMAN STITT: Jeff has a comment.

13 MEMBER NELP: I just wanted to let them know i

(- / 14 that I think they're doing the wrong thing.

15 MEMBER WILLIAMSON: I think it doesn't feel 16 like there's a consensus in this group about 100%

17 supporting this. So, perhaps it might be appropriate to 18 kind of table this motion pending item -- option by option 19 discussion of what the pro's and con's are in light of 20 sort of the principles that motivated us to, you know, 21 construct that alternative IOM report in the first place.

22 And we could come back and see if it's 23 appropriate to vote on it at the end of the day.

24 MEMBER WAGNER: Madame Chairman?

25 CHAIRMAN STITT: Sir?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

144 1 MEMBER WAGMER: I would just like to comment 2 that I understand where you're coming from, John, and I 3 think it's a very good point of view. The only thing that 4 I would regret is that if we didn't reinforce what we said 5 before, it's like we'd be throwing out all the strong 6 recommendation we had in the first place.

7 And I don't want our initial recommendations 8 to go unheard, and I don't want the Commission to think 9 that our initial recommendations are now something we'd 10 like to throw under the rug. The point is, is that we l 11 still -- I still feel, and I think many members of this i

12 committee still feel that this would be the best solution 13 to the problem.

14 We recognize the fact that it's not realistic.

l 15 And at the time, we knew -- recognized the fact it wasn't 4

16 realistic. But I'd like to keep this as being our 17 principal recommendation because maybe sometime in the 18 future, when you look back at the history of this, the 19 strength of this committee in supporting this as the real 20 solution can be referenced, rather than something else.

21 And I want to make it clear that anything we 22 do in the future is secondary to this initial opinion and 23 initial position that we took. And that's why I would 24 agree and support both the amendment and the motion as it 25 was stated.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

-. . -.. . . . - . . ._ ~ . - . - . . -

145

1. CHAIRMAN STITT: I want to let tha rest of 2 this limb of the table make comments, and then we have an

\ t

'V 3 amendment and then a motion. And then we'll spend the 4 afternoon -- we haven't voted on anything yet.

5 Any other comments?

6- MEMBER NELP: Call for the question.

7 CHAIRMAN STITT: Dr. Flynn, you've been very l

8 quiet. Do you have anything you'd like to say?

9 MEMBER FLYNN: No.

l l

10 CHAIRMAN STITT: Okay. We've heard from our l l

11 consultative representatives but non-voting for today 12 representatives. All right, now we need to figure out the 13 order here. We have an amendment that has to be voted on i

\ 14 first. You made -- who made the amendment? Dan, restate l

l 15 your amendment seconded by -- who?

16 And if you don't remember it, --

17 MEMBER FLYNN: Removing the term DHHS and 18 inserting the phrase "by a federal agency, new or 19 existing, with a health or medical focus rather than a 20 regulatory emphasis."

21 CHAIRMAN STITT: Okay. And that is in -- if 22 we're looking at page nine --

23 MEMBER WAGNER: Bullet three. Madame 24 Chairman, if we just remove the last sentence of bullet 25 three, I think that that would be appropriate.

t v

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

146 1 CHAIRMAN STITT: Wall, now, that's a diffcrcnt 2 motion.

3 MEMBER WAGNER: No, I don't think so. I think 4 it says the same thing he -- it's the same thing.

5 CHAIRMAN STITT: Is it? Okay. So the 6 clerical work would be to remove the last sentence, and 7 that would address the motion that is on the floor.

8 What?

9 MEMBER BROWN: Since the current secretary of 10 DHHS declined the invitation, --

11 CHAIRMAN STITT: Right.

12 MEMBER BROWN: -- just cross here off the 13 list.

14 CHAIRMAN STITT: Obviously I didn't talk with 15 her in the right way. Let us vote on the amendment.

16 Everybody clear on -- I think they are. We have people 17 who cannot vote. Everybody else -- is Andrew voting?

18 MR. CAMPER: He can vote.

19 CHAIRMAN STITT: Everybody in favor of the 20 amendment as voiced by Dr. Flynn? Are we raising hands?

21 Okay, those opposed? All right, was that a yes? It was a 22 weak yes, okay.

23 MEMBER WILLIAMSON: I guess it's a w%:, yes.

24 I'll go with the group.

25 CHAIRMAN STITT: 'A weak yes. The group voted NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

l 147 l l

1 unanimously. j f- s 2 We now have a motion on the table, and the I iN- ) 3 motion was made by Dr. Nelp, which was to reaffirm our ,

1 4

4 confidence in the consensus reached by the ACMUI in '

5 February. l 6 Those in favor? Those opposed? We have I 1

7 another unanimous' vote. I think this group really-knows 8 how to work when it's time for lunch. I'd like to -- as 9 you're thinking through and digesting your lunch, think of I l

1 10 what we want to do between 1:00 and 3:00. And I would 11 personally like to have -- to consider that we look at the 12 Commission's preliminary views. l 13 They want to consult with the ACMUI. They l 1

(~'/

(_, 14 want guidance on low risk medical activities, some

, -15 discussion -- we don't want to revise Part 34 this 16 afternoon, but we want to discuss what that means; and

17 guidance on implementation methods, and comments about l 18 using professional organizations.

19 I think that would be worthy so we can let 20 them hear how we feel.

J 21 MR. CAMPER: I agree totally. And I think 22 that the issue that's come up several times -- certainly 1

23 Dr. Alazraki's raised it in this question of guidance on 24 low risk medical activities. I think it would be (v

25 extremely helpful to have an articulation of what those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2344433

148 1 activitico might bs.

2 And I would like to take at least 15, 20 3 minutes at some point in the afternoon, Madame Chairman, 4 to step you through a conceptual model that we considered 5 the other day. And I'd like to have you fill in the 6- blanks in this model, just as a thinking exercise, as to 7 how it would apply to diagnostic uses of matcrials.

8 CHAIRMAN STITT: All right, we're at lunch 9 break until 1:00.

10 (Whereupon, the proceedings recessed for lunch 11 at 12:20 p.m.)

12 13 14 15 16 17 18 19 l

20 21 l 22 23 24 l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS

, 1323 RHODE ISLAND AVE., N.W.

l (202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433 1

149 1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 (1:12 p.m.)

3 CHAIRMAN STITT: We're back on the record.

4 Naomi's going to bring us a cow bell. In the meantime, 5 we're going to get started. We are having something 6' passed out because we're going to start this session with 7 a thought exercise. And maybe with some thoughts, then we 8 can continue on with DSI 7 and 12.

9 I'm going to turn it over to Larry. Also, 10 I've had a couple of people ask me for a point of process 11 or procedure as we are discussing -- raise your hand or

} 12 tip your hand or something and I will -- you will speak p- , 13 when spoken to, all right? No off-the-cuff comments.

s_/ 14 When we have this many people with good ideas, we need to

15 try to line them up.

1 16 So that's going to be our procedure. Larry, 17 go ahead.

18 MR. CAMPER: Okay, I want to make one comment 19 before I started this board exercise, this thought 20 process, if you will. And that is, I do want to make sure 21 that sometime before the day is over that you have -- we 22 got --

you know, we talked about putting comments into two 23 buckets, general reactions to, and then specific reactions 4

24 to DSI 7 and 12 if we assume the Commission will go.

A k) 25 It is very important if you have -- and I NEAL R. GROSS COURf REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M WASHINGTON, D.C. 20005-3701 (202) 234 4 433

1 150 l

1 know, for exnmple, Dr. Wagner did it a littlo bit. If you 2 have -- if the committee has strong views about any of the  !

3 options, one through five, combinations thereof, something j 4 that you haven't covered yet and you feel like it's 5 important to get that on the record, then make sure you do 6 that as well.

7 Because again, I just want to emphasize --

8 we're trying to cover a lot. But getting your reaction to 9 the DSI's, either the options in total, other options --

10 you've expressed -- clearly you've articulated a different 11 option; or the combination the Commission has chosen thus j 12 far, that's terribly important to do that.

13 But anyway, one of the things I want to try to 14 do now is to address something that the Commission asked 15 the staff to do, and that is confer with the ACMUI on low l 16 risk activities. And several times today, certainly Dr.

17 Alazraki's brought it up and others have, this idea of 18 diagnostic. Diagnostic should be different. Diagnostic 19 is a low risk sort of thing.

20 And what we want to do is a couple of things.

21 At some point, I'd like to perhaps get on the record an 22 articulation, if you will, of why it is a low risk 23 activity; and how would we convey to the public -- how 24 would the Commission convey to the public that it's a low 25 risk activity. l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

151 1 For example, you might talk in terms of g-~g 2 relative risk. You might talk in terms of potential for 3 dose; deterministic, if you will. You might talk about 4 the differences between -- from the standpoint between 5 therapy and diagnostic. Whatever you think is the most 6 valid way to articulate why it's a low risk activity and 7 what would be the compelling reason to change how the 8 Commission has regulated that area for 30 or 40 years.

9 But, what I thought might help us facilitate 10 our thinking a little bit is to share with you a model.

11 And we've now passed out a model, and it has seven 12 components to it. And where this comes from is the other 13 day we had a strategy session. Carl Paperiello, Don Cool, (m / 14 myself, Sally Merchant, Josie Piccone -- we met, and 15 Carl's idea was if we were going to change Part 35, how 16 might we do it?

17 What would be sort of our guiding thought 18 process, and what might it look like? So what we came up 19 with was this concept of a modality driven approach. And 20 that there would be -- there could be modules in Part 35.

21 There could be a module, for example, that dealt with high 22 dose rate remote afterloading.

93 There could be one that dealt with 24 teletherapy. There could be one that dealt with

[~T

() 25 radiopharmaceutical therapy. There could be one that l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 2000 53701 (202) 23 4 433

+

152 1 d: nit that dirgnostic. And then, putting anything and 2 everything that we might want to capture under that 3 particular modality.

4 If you look down the list of seven items, 5 there are the things that we, in broad terms, thought 6 should be included. Who would be licensed? Let me give 7 you an example. Could it be an individual physician?

8 Could it be an institution? Could it be either? Could it 9 be both?

10 Technical issues -- for example, what surveys 11 would you expect to see? What access controls -- for 12 example, in teletherapy -- would you expect to see? And 13 on and on and on. Training and experience -- what is the 14 level of training and experience that you would expect to 15 see associated with that modality?

16 Licensee event reports -- what types of 17 activities or what types of events or failures rise to the 18 level of being reported? What about quality management?

19 What degree of quality management should be in place?

20 What records would you expect to see? Would you want to 21 be maintained by the licensee?

22 And then finally, what kind of organization 23 should come to bear? For example, you know today in Part 24 35 we have the radiation safety committee. Do I need a 25 radiation safety committee to be involved in any kind of I

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005-3701 (202) 234 4433 y

l 153 1 oversight an it relates to diagnostic uses, for example? I

)

f-~g 2 Now, I can do one of two things. I can ask j 3 you to fill in this bottle as thought exercise, or I can 1

4 put up an example -- the one we went through the other day 5 with HDR, and that may stimulate your thought. What would 6' be your preference? Would you rather do it blind, or i

7 would you rather do -- see what we have done?  !

1 8 CHAIRMAN STITT: Speak when spoken to, I l

9 Jeffrey.

i 10 MEMBER WILLIAMSON: Thank you. Well, I'm not 11 sure I --

maybe it would be helpful to see the example. I 12 have some concerns about the validity of the model if 13 we're thinking in terms of a new regulatory paradigm

(

14 simply because the categories are -- I would -- to use a 15 term somebody used here, they're "in the box" kind of i 16 criteria.

17 And I would think that if we were going to go 18 through this modality by modality, the first question to 19 ask is, what are the risks; what are the end points with 20 which risk is to be defined? What are the adverse events 21 we're concerned with? And work towards defining the end 22 points that, you know, need to be controlled.

23 And do they have to be controlled then by --

24 through regulation, or adequate -- or professional and q ) 25 practice standards that exist -- adequate or more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200053701 (202) 234-4433

154 1 appropriate to control for those things. That gives us i 2 then what's left over for regulation. Then perhaps the  !

3 issue of how should the regulations be drafted to handle i 1

4 those end points would be kind of like the last thing. I 5 l I mean, that's just my off the top of the head l

6 reaction.

1 7 MR. CAMPER- There's no question about that.

l 8 You're absolutely right. And this model does not assume l l

l 9 that it is the model. It does not assume it's a model 1

10 that we use at all. It was merely a tool that we used 11 from our perspective as regulators to focus our thoughts i 1

12 on what Part 35 might look like if it was going to be 13 driven by risk and modality.

14 My purpose in sharing it with you now is Ol 15 merely to try to get a -- as a means of trying to draw 16 some attention to this question of the low risk activities 17 and diagnostic. Now, basically your point is, how can you 18 use this model or any model until you, you know, put out 19 your underlying assumptions as to how you should even 20 regulate this.

21 And of course, valid point. Totally valid 22 point.

23 CHAIRMAN STITT: Sally, did you have a 24 comment?

25 MS. MERCHANT: My only comment is we did this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

155 1 very preliminarily as a very, very early start on trying 2 to come to a way of defining the risk. This is way before

\

3 where you are. I mean, we're not looking at it as 4 seriously as -- I mean, you will see no definite 5 suggestions for regulation.

6 We're just saying what kinds of things that --

7 Larry will walk you through it, but's -- even preliminary 8 to that, we're trying to come up with some way -- and this 9 was not a definite model. We know that. This isn't the 10 model we'll end up with. We're aware of it. We just 11 wanted to try to identify some way to -- you've got to 12 start somewhere.

13 CHAIRMAN STITT: Wil, you had your hand up.

(, 14 MEMBER NELP: Well, in problem solving, it's 15 much better that you present your preliminary solution and 16 we critique what's in there. We also will see your model 17 at the same time. So it saves one step. We're going to 18 view the model.

19 MR. CAMPER: That's right. If you would l 20 prefer to approach the question of low risk activities in 21 medicine -- and in particular, this question of diagnostic 22 --

in a different manner, then we can certainly do that.

23 This was just a particular approach to congeal thoughts.

I 24 Do you have a preference? i p- s i

) 25 CHAIRMAN STITT: My question is, if we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVEL, N.W.

(202) 2344433 FASHINGTON, D.C. 20005 3701 (202) 234 4433

_a

156 1 talking about low rink activitico, you acid you had done 2 this model for high dose rate brachytherapy. Those aren't i 3 the same issue. Where are we?

4 MR. CAMPER: No, we're -- I was going to take 5 this opportunity following this model to ask you to fill 6- in the blanks as it relates to low risk activities, 7 diagnostic in particular. My point about the HDR was we 8 did it because it's easier because it is a higher risk 9 modality.

10 CHAIRMAN STITT: Okay.

11 MR. CAMPER: My point -- my question was, did 12 you want to see how we filled in the blanks?

13 CHAIRMAN STITT: Oh, sure; we want to see how 14 you filled in the blanks.

15 MR. CAMPER: Or did you want to do it blind?

16 I'd rather you do it blind, but that's okay.

17 CHAIRMAN STITT: Well, I want to get the 18 diagnostic and nuke medicine people here involved in this 19 low risk --

20 MR. CAMPER: All right. Sally, where's the --

21 we'll show our --

22 CHAIRMAN STITT: While he's finding his visual 23 aids -- John, you have a comment?

24 MEMBER GRAHAM: Well, I just want to clarify 25 one of the options. Once we've gone through the model NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433 ,

157 1 with HDR is that fo,r low risk, you would start the sheet

- 2 by saying it doesn't apply. Low risk, by definition,

\

N- 3 j falls outside this regulation.

4 MR. CAMPER: I totally agree. Again, I only 5 offer this so you can see what we s:ere thinking in terms 6- of a more higher risk. I would fully expect that the 7 blanks will be filled in differently for a lower risk

, 8 activity.

9 MS. MERCHANT: And reaction.

10 MR. CAMPER: Right. But it's just something I

11 to try to get some thoughts on what this low risk 12 activities are and what it means to diagnostic.

13 Well, for high dose rate remote, our thinking

~(_,) 14 was that who might be licensed? It could be an 15 institution, it could be a physician, it might be a mobile j 16 situation, and it might be either. It could be

{

17 combinations of-these things.

l 18 For the technical issues under HDR, we 19 identified hardware issues, other issues, and emergent 20 intervention issues. For example, under hardware, we said 21 it's a lot like teletherapy where you have concerns about 22 access, you have surveys, you have calibration 23 expectations, safety instructions, leak testing.

24 There could be concerns about power sources 4

[s

\_ /

\ 25 with HDR's. Other considerations would be software, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200053701 (202) 2344433 4

158 1 acccptance tanting. Cable, lengths, for example, have been 2 a problem with some of the misadministrations of HDR.

3 Then, of course, the emergent intervention is this idea of 4 a loss or stuck source in the patient's body.

5 Under T&E -- in broad terms, we clearly 6~ thought there would be a concern about the level of f

7 training and experience for physicians. There would be a 8 concern about level of training and experience for

. 9 physicists. And the question of 10 dosimetrists/ technologists. We don't do that now.

11 But this is an area I think most of you would 12 agree in HDR that the technologist and the dosimetrist can 13 have a marked impact on the outcome of the procedure. And 14 currently we have no minimum training and experience. So 15 should that person -- and our thinking was perhaps it 16 should be.

17 Under the category of LER, which is a licensee i

18 event report, as opposed to a misadministration, we l 19 thought that getting at -- one of the problems that the  ;

20 medical community had today with the term 21 misadministration is it's a term that is troubling to the l

22 community. It seems to imply something very negative. As !

23 you know, it's an error in the reporting -- in the dose 24 process.

25 It's a percentage. I mean, we got there a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

159 1 number of ways which we could talk about. But the point 2 is, the way it's structured today, it has so much to do 3 that flies in the face of the practice of medicine. And 4 so, our thinking was well, really, there are things that 5 seem totally legitimate to be concerned about as a 6 regulatory agency.

7 Machine failure is something that seems to be l 8 worthy of being reported. Software failures seem to be

'4 9 worthy of being reported. Firmware failures, patient 10 harm. And perhaps what we need to do is to define patient 11 harm.

12 MS. LIPOTI: What's firmware?

13 MR. CAMPER: Firmware. What was firmware, '

(

b 14 Sally? That was Carl's word.

15 MS. MERCHANT: It's different than hardware.

16 MR. CAMPER: Different than hardware.

17 CHAIRMAN STITT: Support pantyhose.

18 MR. CAMPER: Well, yeah; I guess. It's 19 different than hardware.

20 MEMBER WILLIAMSON: It's computer code.

21 MR. CAMPER: And it's different than software.

22 It could be, for example, electrical circuits, that type 23 of things. What did you say, Jeffrey?

24 MEMBER WILLIAMSON: It's computer code.

O 25 Computer program that's encoded in the electronic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

l (202) 234 4433 WASHINGTON, D.C. 20006-3701 (2C2) 23M

i 160 1 hardwara.

2 MR. CAMPER: Okay, there we go.

3 MEMBER WILLIAMSON: As opposed to software, 4 which is a set of instructions that you can enter and 5 modify at will.

6- MR. CAMPER: There you go. Okay. Patient 7 harm -- perhaps moving away from the idea of 20 or -- 10%

8 or 20% error in the delivery process. Moving to a level 9 of patient harm which is not easy to define, by the way, 10 for a host of reasons you understand very well. But maybe 11 events that constitute patient harm.

12 Leaking sources, which seem to be worthy of 13 being reported. Overdoses -- perhaps overdoses of some 14 consequence or some threshold to be defined. Calibration 15 errors; facility failures such as interlock failures, for 16 example. In the case of a mobile HDR, a vehicle accident 17 or certain categories of vehicle accidents would seem to 18 be something that would be worthy of being reportable.

19 And then from the standpoint of quality l 20 management, our thinking was that perhaps there are parts 21 of the quality management rule that seem worthy of being 22 retained. And if they were, what were they? Well, 23 knowing that you've got the correct patient. We did first 24 explore this question of does the program need to be 25 written, does it need to be submitted.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

161 1 And we wanted to exploro this issue with the

! -~ss 2 states about that because they certainly had a -- the 3 states clearly had a strongly different position about the 4 necessity to submit quality management programs if they 5 exist. So we said okay, if we assume for sake of 6 discussion that you have a QM type thing, what must it 7 minimally consist of as it relates to HDR?

8 Well, you'd like to know that you have 9 something in place that would require the correct patient 10 to be irradiated. You'd like to know that you had some 11 written direction. Maybe the written directions should be 12 the treatment plan rather than a written directive. One 13 of the problems that we have today with the quality m

14 management rule is that we created this thing called a 15 written directive.

16 And we often find ourselves in an 17 interpretation dilemma between the information that's 18 available in a treatment plan versus that which is 19 required in a written directive. And then the idea that 20 one would verify that in fact the dr.ae that was actually 21 administered is consistent with that which was required by 22 the physician.

23 Now, again, under this model, and looking at a l 24 more higher risk modality, HDR, these were the things that I

()

i f-ss '

25 we thought of in general terms under those categories.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

162 1 And with regarda to tha -- there's a few more -- records, 2 we have survey records, calibration records, maintenance 1

3 records. Probably keep a record of the treatment plan. l 4 Leak test records, and any events which are 1

5 reported. And then under the category of organization, l 6- internal quality assurance, we felt that for a multi-7 modality facility, a radiation safety committee would 8 still be needed, and that HDR representation should come  !

9 to bear on that committee.

10 But that for a single modality shop -- say, 11 HDR only -- that a medical physicist /RSO would probably be 12 adequate in terms of organizational control and quality 13 assurance. So , again, using this model as a sort of a 14 quick modality driven, risk oriented approach, those are 15 the items that we filled in.

16 Now, certainly Jeffrey's comment is valid in l 17 terms of well, you know, I question the model. That's 18 valid. I mean, you question whether or not you should 19 even have a model yet. That's valid. But we were just 20 trying to think about what should it look like with 21 modality in mind and risk in mind.

i 22 Now the question is, using that model, could j 23 you fill in the blanks as it relates to diagnostic nuclear 24 medicine use? Maybe you can. If you can't, you can say 25 so.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISt.AND AVE., N W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 23M

1 163 '

l 1 CHAIRMAN STITT: Well, is this then a good l

(~w 2 time to go ahead -- my understanding is that we ought to t

'/ 3 get some things into the record regarding -- well, J 4 guidance on low risk medical activities. i 5 MR. CAMPER: Right.

I 6' CHAIRMAN STITT: This'is certainly our I l

l 7 opportunity and we've got a full panel here to discuss 8 that. A couple of hands were up here.

9 Jeffrey?

10 MEMBER WILLIAMSON: Well, I have some -- I 11 guess I'll just repeat my concerns. I think this begs an i

12 awful lot of questions. Why are those specific elements

,-_, 13 picked out as technical issues? There are many technical

( i

'\__/ 14 and clinical issues regarding the use of HDR that are 15 involved in the issue of, you know, adverse events which 16 may or may not have harm to the patient. l 17 And the basis on which these are all picked 18 out is, to me, not very clear. And that was my concern.

19 First of all, if we wrote down sort of your current Part 20 35 categories, that kind of, to some extent, dictates what 21 the answer will be. Whereas, I do think there's a need 22 for alternative regulatory paradu om here.

23 If -- first of all, you know, we would have to 24 ask questions. Why are you -- are you going to be O

(j 25 continue -- is NRC going to continue to be concerned about NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

164 1 the quality of trcatm:nt rendsrsd to thn patient? 10 th2t 2 going to continue to be a regulatory end point as opposed l 3 to the issues related to control and security of radiation 4 sources, loss of radiation -- of radioactive sources, 5 maintenance of records, exposure of personnel, recognizing 6 that radioactive sources are different than their -- from 7 their electronic counterparts in that they can't be 8 completely turned off ever.

9 And they can be lost and go out of control in 10 a way that a -- like a linear accelerator can't.

11 MR. CAMPER: Well, let me try to -- you may --

12 it's certainly true t' hat you may look at this bottle --

13 just this bottle, and fill in pieces differently. This 14 was our collective thinking done in about an hour's time 15 from our perspective as regulators.

16 We -- with regards to your comment just now 17 about the characteristic of sealed sources, we look at 18 this and say yes, you're right; and therefore, it follows 19 that certain things obviously need to be in regulations to 20 control sources which have the very characteristics that 21 you just said.

22 That they're straightforward to common sense -

l l 23 - I mean, I think most people would agree calibration, 24 safety instructions, access controls, leak testing -- this 25 is pretty straightforward stuff. Now -- but again, bear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON D.C. 20005-3701 (202) 234-4433 l

1 165 1 in mind that this fundamental question -- and I think I l

-~s 2 said this this morning and I'll reiterate it.

3 You're absolutely right. And one of the 4 things that we intend to explore with the Commission as we 5 proceed to look at any revision of Part 35 is what about 6- patient safety. Therefore, what about the 1979 Medical 7 Policy Statement? That is a crucial policy issue that the 8 commission will ultimately have to decide upon.

9 And whatever it decides to do will then in 10 turn largely impact certainly what you do about things 11 such as patient harm, reporting of overdoses, --

'12 CHAIRMAN STITT: John has a question. I'm 13 sure you want --

O)

(s, 14 MR. CAMPER: For example, the Commission might 15 look at that and say that's purely a practice of medicine 16 issue we're not going to deal with any more. I don't 17 know.

18 CHAIRMAN STITT: Larry, respond to John's 19 question, which is probably what is --

20 MEMBER GRAHAM: Specifically, what is the 1979 21 Medical Policy Statement?

22 MR. CAMPER: I don't have it in front of me.

23 The 19 -- in 1979, the Commission issued it's Medical 24 Policy Statement. And the Medical Policy Statement said

((~)j 25 that we will do certain things. And in broad terms, what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

1 l

166 1 it caid is th t wa will continua to regulate the 2 protection of occupational workers involved with medical 3 uses; we will continue to regulate patient safety; we will 1 l

4 attempt not to intrude on the practice of medicine; and we 5 will put in place those standards or requirements that 6 seem to be in nonexistence as a result of activities by 7 the regulated community.

8 That, in a nutshell, is what is says. And one 9 of the fundamental -- it's item two of the 1979 Medical l 10 Policy Statement. And basically, it is the one that says 11 we will regulate patient safety. We will regulate safety l 12 of members of the public, we will regulate the safety of 13 occupational workers, and we will regulate the safety of 14 the patient.

l l

15 Jeffrey's comment is really about that very l

16 point. And that is, does the Commission want to continue 17 to concern itself with patient safety; or to what degree 18 does it want to continue to concern itself with patient 19 safety. That in turn then will, to a significant degree, 20 dictate what Part 35 would look like. But you're 21 absolutely right. That's an important --

22 MEMBER WILLIAMSON: What I'm proposing as far 23 as a topic of discussion for this committee is even for 24 the high risk applications, I don't -- I think we should 25 have a discussion and make a recommendation on that issue l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON. D.C. 20005 3701 (202) 234 4433

- .- . . . . ~ . . -.- - -. - -- .. .

167 1 as to what should be the involvsmsnt of NRC vis-a-vis that i

g 2 input. i

'- 3 CHAIRMAN STITT: Lou?

1 I

4 MEMBER WAGNER: Just as a point of 5 clarification, I knew I saw it somewhere, DSI 7, Section i l 6 3, on page 11 on the materials that were handed out to us.

7 This is for DSI 7. It says, "Also to be considered is the 3 8 interpretation that the Commission has adopted and l

9 implemented that medical patients are included in the '

i j 10 *public'."  !

11 That's the issue.

12 MR. CAMPER: Well, that's certainly'-- yes, j 13 that's the issue that Dr. Williamson has raised. That's lN, 14 the issue as it felates to the Medical Policy Statement in 15 item two. And that's an issue that the Commission will 1, _

1 16 need to reexamine as we consider revision of Part 35, 17 absolutely.

18 Let me just again point out -- if this is not 19 the way to do this, this is only -- this was only offered

20 as a way of trying to congeal thought in a quick manner i

21 about diagnostic low risk activities. I don't -- I'm not I

j 22 saying the model is the holy grail. I'm only saying it's i

23 a tool. If there's some other way you'd like to do it, i

24 that would be fine too.

4

[V\ 25 CHAIRMAN STITT: This discussion that was just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000M701 (202) 234-4433

1 168 1 brought up, I'd lika to continue on that lins. And I know 2 Lou has some burning opinions that I think should be 3 expressed. And I want to remind the group that the first 4 point of what we just reaffirmed was rebuild the medical 5 use regulatory program without using current regulatory 6- program as a starting point.

7 I would like to, with that in mind, continue 8

discussion after this limb -- we have the left limb and 9 the right limb -- makes their comments; and make sure we 10 talk about guidance on low risk medical activities. The 11 commissioners have asked us to comment specifically on 12 that.

13 Lou, go ahead.

14 MEMBER WAGNER: I feel relatively strongly 15 that we have to go back and look at the history of why we 16 got to where we are, which means somewhere along the 17 evolution and the development of all the regulatory 18 methods, we've come to this point. And it's a mess, and 19 we're trying to correct it.

20 And I think this is the turning point of where 21 things started to go awry. Because at this point, the 22 Commission adopted the policy that medical patients are 23 included in the "public". And that's where the Commission 24 -- and the Nuclear Regulatory Commission started to try to 25 regulate the medical community when they had no NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON D.C. 200053701 (202) 234 4433 l

169 1 experience, no expertise in medical care.

g-~ 2 So I think that this is really one of the >

3 starting points, one of the very vital issues about where 1 4 we're going to go from here. There is probably one of the 1 5 biggest and most important bones of contention in the 1 6 regulatory process -- the interference with medical l 7 practice.

8 And I think that this is a very important 9 thing to discuss, and probably vital to the future of what 4 10 we're going to do.

11 CHAIRMAN STITT

Thank you. Larry has a

, 12 ' comment .

13 MR. CAMPER: Just a comment. I think that Lou (s,/ 14 makes a very profound point. And I think in having said

15 what he said and agreed that it is profound and I think it 16 is a point where one can look back now and say this is 17 where you start going a particular way. Now, let me share 18 with ycu then, you know, for truth in lending, why that 19 happens.

20 Okay, it came in 1979, and it came about, just 4

21 as did the major adjustment to the teletherapy 1

22 requirements, as a result of the events in Riverside, Ohio 1 23 in which you have 250 or so -- I forget the exact number 24 now -- of patients overexposed, the number of patients 25

( j deaths and so forth and so on.

NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

! (202) 234 4433 WASHINGTON. D.C. 20006 3701 (202) 234 4433 1

a 170 1 And tha commission took tha opportunity at 2 that point to clearly articulate its position as to what 3 it wanted to do. And it was that it wanted to be involved 4 in patient safety. So it's important to know what was 5 going on at that time and why it took the position that it 6 did.

7 Subsequently, in 1980 -- and that was the 8 third element, if you will, third leg of the triangle; one 9 being the teletherapy change, two being the 1979 Medical 10 Policy Statement, and three being the misadministration 11 reporting requirement in 1980. And it is no question 12 about it that those things were, to a great degree, 13 resulted from the events in Riverside, Ohio -- or

[ 14 Riverside Methodist Hospital, actually.

15 CHAIRMAN STITT: John?

16 MEMBER GRAHAM: Well, one observation policy 17 that was considered good government in 1979 -- in a number i 18 of cases, probably wouldn't be considered that in 1996.

19 And just as a process issue, is that statement available 20 for this group to use as a starting point to recommend how 21 that 1979 statement should be modified?

22 And by modifying that statement, effectively 23 preclude low dose radiation from comprehensive regulatory 24 review? I've never seen that statement, so I guess I'm a 25 bit surprised to hear it exists.

NEAL R. GROSS COURT REPORTERS AND TRAMSCRIBERS 1323 RHODE ISLAND AVE. N.W, (202) 234-4433 WASHINGTON, D.C. 2000?-3701 (202) 234-4433

171 1 CHAIRMAN STITT: Yes, I've seen it before; but 2 it's in the big, thick book.

f- g I've made some slides off of

(\- ') 3 it because it is interesting, particularly if you're in 4 the medical field because they do make the comment of not 5 interfering or not practicing medicine. But then there's 6- a real bind when you start saying we're not going to be 7 practicing medicine, but patients are a member of the 8 public.

9 So we'll see if we can come up with that. I 10 think it relates to the questions that we're being asked 11 to discuss and comments we're being asked to send back.

12 MR. CAMPER: I would agree totally. And I 13 think the committee can conduct its business as you think b\

( ,/ 14 it's best, you know, to get at the issues. And your 15 point's well made. I mean, one of the things you might do 16 is you might take the 1979 Medical Policy Statement, 17 examine it, and articulate your positions on-each element 18 of it.

19 And you might suggest that it be modified in a 20 certain way. And then that modification could serve as 21 the basis for what Part 35 in turn would look like.

22 Because I think it is an accurate statement that certainly 23 the Medical Policy Statement set the state for many of the 24 changes that subsequently occurred in Part 35.

f%

25 CHAIRMAN STITT: I want to confer with Larry NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433 l

172 1 one second. You guys keep thinking. Let me try this on 2 for size.

3 What are you laughing at?

4 MEMBER WILLIAMSON: I'm sorry.

5 CHAIRMAN STITT: No, I know you're not.

6 MEMBER NELP: He's a happy person, 7 CHAIRMAN STITT: No, you're not. All right, -

8 -

9 MEMBER WILLIAMSON: Well, I was going to make 10 a suggestion.

11 CHAIRMAN STITT: You were not called upon.

12 MEMBER WILLIAMSON: You asked us a direct 13 question.

14 (Laughter.)

15 CHAIRMAN.STITT: I like the way this is going.

16 I have a suggestion first, and then I'll hear your 17 suggestion. I like this power business.

18 The '79 -- the points that are made in that 19 '79 issue are interesting. And we need those. And I 20 think Sally went off to find them. What do you folks 21 think about moving to a discussion of mobile HDR? Yeah, 22 Bob is back there. That is, stopping right now, let's 23 move on to something that has maybe something finite that 24 we could talk about.

25 And when we have the '79 -- 1979 commentary in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

173 1 front of us, starting this discussion up again. Naomi's e"% 2 sort of like, yes --

3 DR. ALAZRAKI: Well, that's okay with me. I 4 think though that we could come to some -- have some 5 meaningful discussion about the diagnostic versus the 6- therapy. But we could do it after we hear the other -- it 7 doesn't matter.

8 CHAIRMAN STITT: I agree with you, and I want 9 to do that before we finish today. I think it's worth 10 seeing those points that are in the 1979-commentary 11 because it does have some relationship.

12 MR. CAMPER: That's an hour.

i' 13 CHAIRMAN STITT: What, for mobile?

I

\d 14 MR. CAMPER: Okay?

l a

15 CHAIRMAN STITT: Well, this whole thing is ,

1 16 several hours. What was your comment, Jeff?

?,

17 MEMBER WILLIAMSON

Oh, since you weren't l.

18 really asking me for a comment but only making a 19 rhetorical request, I withdraw my --

20 CHAIRMAN STITT: Jeffrey withdraws. Let us J

21 re'flect that. We're going to spend all day with our hands 22 raised.

23 Sir?

24 MEMBER SWANSON: 'm me, it's important that we IO 25 get to the issue of whether .- atient's included as part NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS

, 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

174 1 of the public in order to make an accoesment of risk.

2 Because if you look, for example, at the risk of a  !

3 therapeutic procedure versus a diagnostic procedure, I 4 think all of us think in terms of patient risk. I 5 But if you think in terms of occupational 6 worker risk or public safety risk, one could create an 7 argument that, as we were talking earlier, we are 8 distributing lots more millicuries of radioactivity 9 associated with the diagnostic use around the country than 10 we are with the therapeutic issue.

11 So, it comes back to this is important in our 12 ' discussions of risk.

13 CHAIRMAN STITT: And that's exactly the 14 question I raised this morning and nobody jumped on it.

15 But it will come up. I do want everybody to have that 16 statement in front. I think it's helpful to see, because 17 we are starting from a historical perspective.

18 What Ayres has to present is an hour long.

19 MR. CAMPER: But he'll do it in 45.

20 CHAIRMAN STITT: But he'll do it in less time 21 because I've already got the answers to that issue. Plus, 22 what it at least does for mobile is we've got our therapy 23 people here, so it's -- almost cuts down the number of 24 commentary. Let's take a run at it.

25 MR. CAMPER: Quickly, as Bob is setting up, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 23& 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

175 4

1 this was an item that was added to the agenda at the I 1

2 request of Bob Quillin. And Bob wanted to know how we're t.

3 dealing with this mobile HDR. We've talked with the 4

i 4 committee about it a little bit in the past, but we're 5 going to show you how we have handled this application J 6 that we've had thus far. i l

i j 7 And if you identify any significant technical  !

4 8 or safety issues, it would be interesting to hear what ~

I i

l 9' they are. l i.

10 MEMBER FLYNN: Do we have enough time at the 11 end to comment? Because I have quite a few --

12 MR. CAMPER: Yeah, yeah. Bob's going to have

?

l i 13 to do the foot dance accordingly and cut it shorter if f

14 need be, and whatever.  !

15 MR. AYRES: Well, I will comment that Larry 4

4 16 was talking earlier about getting you in earlier and i

j 17 earlier in the process. If you was any earlier in this i

l 18 one, you'd be practically part of the writing group.

19 What we did, we finally got our first 20 application for mobile HDR, which prompted us to then 4

3 21 develop the corresponding guidance necessary to license

22 this. And we attempted to do it through a modification of 23 the BPR process which involved a writing team, and we 24 invited people from several agreetaent states and various 25 other NRC offices to participate.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS

- 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (*M 234 4433

176 1 Ws cnd;d up with ths State of Mnrylcnd

(

1 2 providing a lot of assistance on developing this guidance.

1 L

3 The status of it is right now that it's all l l

- this is 4 material just out of the writing team. It's in management We haven't even went through the first 5 review right now.

l 6 level of management review.

l 1

7 So you're seeing it basically raw material.  !

1 8 So, if I could start with the next slide. I wanted to 9 define the terms. There's really two types of mobile 1

10 applications being proposed. Our license application that 11 we currently have in house is for this one, which I call 12 self-contained mobile HDR brachytherapy facility.

1 13 It's a -- looks like this is a little bit in 14 my way. I don't know if it's in anybody else's. It's a I l

15 mobile HDR treatment f acility tha t provides -- that is i 16 ready to provide and deliver mobile HDR treatment services 17 on arrival at the client sites and an entirely self- l l

18 contained van or trailer facility with the shielded 19 patient facility already on board which includes the HDR 20 device, viewing, and all the intercom facilities.

21 The current device available has -- in fact 22 the sealed source and device radiation safety review 23 encompasses the entire van. There would obviously be two l

I 24 routes to go. Review just the HDR itself. In this case, 25 the state that did this review did it as the entire i

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

177 1 fccility. And the next alida just simply chows a picture j7-s 2 of that type of facility.

\N--) 3 Those of you in the therapy area are probably l i

)

4 familiar with it. This is the HDR device itself, and this 5 is the lead shield in which the patient is treated in. It i

6 also includes a simulator, dark room facilities, the 7 treatment planning, everything that's necessary to provide d

8 patient treatments in one self-contained mobile facility.

9 Next slide. The other type -- and we included 10 this because we knew applications would be coming -- of 11 mobile HDR services would be what we call the 12 transportable unit where the only thing that's moved from 1

) 13 treatment site to treatment site is the HDR itself. And 14 there's really a couple of ways -- the other -- in that 15 case, for licensing, we review the entire facility as we 16 would for a fixed facility for each of the client sites l 17 the shielded treatment room, the shielding calculations, 18 the support equipment such as viewing systems, area T

19 monitors, intercoms, which is all included in the self-20 contained facility.

21 There are -- as we go on a little further, 3 22 there are a couple of ways to license this, and I'll deal 23 with those a little bit. For the guidance, we wrote this 24 to supplement our existing guidance. All we did was write i

O)

(

V 25 this guidance to address those issues that are unique to NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 29005-3701 (202) 2344433

178 1 mobilo. 1 2 We presume that Reg. Guide 10.8 and the new 3 revision, which most of you have reviewed at some point in 4 the process and as in the process of being prepared for a 5 publication and public comment now, would apply as well as 6- our -- right now our current HDR licensing guidance, which 7 is in policy and guidance directive 84-4.

8 This guidance that I'm presenting to you now 9 just supplements that. It adds to it. And it 10 specifically applies to the licensing of mobile HDR 11 medical treatments either as fully self-contained or 12 transportable.

13 Next slide, please. We need to address both -

14 - two areas; the regulatory issues and, of course, what 9ll 15 our interpretation is. And this is the main place we'll 16 be looking for comment from the committee -- those things i

17 that we deem to be important, health and safety issues.

18 Ne::t slide. The only real regulatory issue we 19 had to deal with, and the critical one here, is our 20 current regulations. In particular, 10 CFR 35.29(a),

21 which authorizes the licensing of mobile nuclear medicine 22 services by excluding -- prohibits mobile therapy 23 services.

24 So therefore, we had to generate -- as part of 25 this guidance and requires the approval through the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

. . - - _ _ _ . -~ . . ~ _ - . - - - - . . . - . ,-

179 1 managem:nt process -- of an exemption to this regulation r

2 to permit mobile therapy services. And that would be done .

\

3 through the sample standard license condition we would add 4 to the license. '

5 Rather straightforward. Next slide. Now 6 getting into the health and safety iss2es -- again, reiterating that this is an addition to the existing 7

8 guidance. Specifically for mobile remote afterloading 9 applications, we felt we needed to supplement the existing 10 guidance in terms of locations of use, radioactive  !

t 11 material, the facility diagram, operational safety checks, 12 and transportation, which has not been addressed before in i t

i 13 remote afterloading. '

l's. / 14 So, taking each of these in turn -- next slide 15 -- or. the location of the use, we've got mobile location.

16 So obviously we have to address this issue. First, we'd l l

17 want to specify a central base location for the mobile '

18 treatment facility or the transportable device. )

19 This would apply to both. I'll mention it 20 where they differ between the two types of modalities.

21 And at that location, that's where we'd expect the routine 22 maintenance of the device would occur. That's where the i

l 23 byproduct material would be delivered and/or stored that

. 24 wasn't in use in the device.

( 25 The source exchanges would occur there, and x_

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) W dm WASHINGTON, D.C. 2000lL3701 (202) 2344433

i 180 l I

1 thet would ba a centrcl records location. l l

2 Next slide, please. Then we have the I

't 3 additional sites, the temporary client sites which, again, O 4 would apply to both mobile and transportable. There, I 5 we'd expect to get a letter from the client authorizing 6 the use of the byproduct material at their address. In 7 other words, what's being done with their concurrence and 8 permission.

9 One of the things that might be more 10 controversial is the next one. We seem that it would be a

11 an appropriate part of the emergency plan to have an 12 agreement with a nearby medical facility to provide care 13 for any medical emergency that might arise when the 14 patient is undergoing treatment under the mobile 15 facility's care.

16 And this should include procedures for 17 handling emergencies arising from the inability to remove 4

18 the HDR source from the patient. Next slide. Extending 19 that a little bit and following our normal -- if the 20 applicant can provide assurance that no treatment will be 21 performed -- they will not perform any treatments that 22 would result in a source, if it becomes jammed or 23 detached, that couldn't be removed, that they could always 24 be assured of removing that source by an easily removable 25 applicator, for example, such that they assure a medical -

l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4 33 WASHINGTON, D.C. 20005-3701 (202) 23M

181 1 - surgical techniques wouldn't be required, then wa could 2 exclude that requirement.

s/ -3 Then unique to transportable services, the 4 additional information that we'd need, because we would l 5 have multiple different shielded facilities, not a single >

6- one that moved from site to site. For each site used, the 7 applicant would need to tell us about all the information 8 required under the normal facility section such as the 9 shielding, the drawings, the viewing devices, the 10 monitors, and so on and so forth that go with assuring  !

11 that the shielded treatment facility is adequate for the 12 intended use.

13 If the applicant -- that is, the mobile (A,) 14 facility - will be doing the patient treatments --

15 another option is they just provide the device -- they )

l 16 need to provide proof that establishes that the applicant  !

17 io in full control of the facility, that being the  !

18 shielded treatment room or any other components they need.

19 In other words, they can't be in the middle of 20 a patient treatment and the customer say, you know, I've got to gain immediate access for some reason or something.

21 l

22 They have to have full control, a reasonable requirement. l l

23. Next slide. l 24 If the -- the other option would be that the

/"'N l 25 mobile facility simply provides the device to the client.

}

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVEL. N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

182 1 The client in turn has their own licen s, io cuthorized to 2 provide HDR treatments under that license with that device 3 because we require specific device training for the 4 physicist and the authorized user and so on.

5 Then the applicant would simply be licensed to 1

6- transport the device from location to location, to the 7 servicing, source exchanges, etc.; and would have to 8 provide us with copies of their customers and clients NRC 9 and agreement state license showing that the client is 1

10 authorized to provide the treatment. l 11 And they -- that authorization is specific to )

12 the device they're going to be using. Another thing --

l 13 there could be a lot of variations on this. The mobile 14 facility could provide not only device, but say, could 15 provide the physicist under contract. That's not an 16 unusual situation in some facilities anyway.

17 So they could provide additional things. But 18 -- so you have a branch in the transportable. The mobile 19 service providing the entire patient treatment services 20 and just using the client's facility; or the mobile 21 service simply providing the device and the client has the

! 22 authorized user and license to do the service.

I I

23 MEMBER WILLIAMSON: It's presumed the client 24 provides the physician all the time.

25 MR. AYRES: The client provides under all of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

183 1 the current sch:mso that wa're aware of end that this f'~N 2 license is based on, always provides the authorized user,

't )-

3 yes. And then last, the initial installation and function i

4 checks at each client site must be made by the device 5 vendor -- in other words, the certified installation, all 6- the necessary interlock wiring and so forth installed and 7 certified according to the specifications.

8 That's normally often part of the sealed 9 source and device safety review. That's a requirement 10 embedded in most of those. Next slide.

.t l 11 I think I'll be able to get through this 12 relatively quickly. On the radioactive material, the only

, _s 13 thing we're doing is reminding the license reviewer that

'/ \

\_ /. 14 the device has to be specifically approved in the sealed 15 source and device review for mobile applications. And 16 what that has entailed up to this point has generally been 17 two things. That the device source safe has been 18 certified as a DOT type 7A container; otherwise, 19 transporting it would be in violation of DOT regulations, 20 49 CFR.

21 And the other requirement that's normally done i

1 22 by the reviewing agency is to require vibration testing.

i 23 In the design of the device, that usually entails securing 24 the circuit boards and anything else that might be related j 25 like that to permit them from coming loose or apart during l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433 l

184 1 vibrations cncountorsd in transit.

2 The radiation safety evaluation would be done 3 either by an NRC or an agreement state and listed in our 4 registry of sealed sources and devices, which simply 5 provides a mechanism for all licensing entities to use 6~ that. Presently taere are two such devices that have been 7 reviewed and authorized for this.

8 There is the transportable device done by an 9 agreement state -- or done by us -- done by NRC, the 10 evaluation; and the mobile, which was performed by an 11 agreement state. There's some others, I understand, 12 pending. Next slide.

13 on the facility diagram, they should provide 14 -- this pertains now back -- going back to self-contained '

15 only. They should provide drawings with sufficient detail 16 that the conformance of the facility sealed source and 17 device radiation safety evaluation can be verified.

18 In other words, as I said, presently the 19 practice has been that the safety evaluation encompasses 20 the entire facility. And these things are subject to 21 design change from time to time. And if they deviate 22 sufficiently, it may invalidate the existing sealed source 23 and device review.

24 Then a separate drawing should be provided for 25 each client site showing the location of the treatment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200053701 (202) 234-4433

d 185 1 dsvico vshicle in relation to nearby roada, cidawalk r'% 2 structures, and other locations that could be occupied by

-('" ) 3 members of the public. Simply looking at potential public 4 exposures there.

5 Next slide. The location of the device 3

6- vehicle must be on client-owned or centrolled property

~

7 that is covered under their letter of agreement. No 8 vehicular traffic should be permitted in the imnediate 9 area of the treatment facility that can potentially 1

10 inflict damage to the facility or adversely affect patient I

11 treatment.

12 In other words, it shouldn't be positioned in 13 an area that a van could drive into the side of the i/

\s_/ 14 treatment facility during patient treatment. That could 15 produce all kinds of unwarranted, potentially harmful 16 effects. It might entail -- we'll review these drawings, 17 something like some barrier posts or jersey barriers to 18 protect the facility where it was located. We're in new 19 territory here.

I 20 Okay. Next slide.

21 (Slide change)

, 22 MR. AYRES: Operational safety checks. We

23 have a concern that the device has now been subject to 1

4 24 vibration and other effects in the process of being 1(O) 25 transported, so we want to check that everything is okay NEAL R. GROSS

, COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 200063701 (202) 23M

186 l

1 bafore wa etert trceting patiento -- simple common ecnso 2 type of thing. As I said, since the movement of the l

l 3 device increases the risk of failure, it's important that 4 you recheck the operation before we start using it.

l 5 Rather than daily, we have moment. l l

6- If they treat in two locations in the same l 7 day, they'd have to do it twice. And they should j 8 basically do those that are already required and the l i

9 details are in your guidance there. We omitted a couple 10 like measuring the catheter links, which aren't going to 11 change through to transport, but common sense safety 12 checks.

13 Next slide, please.

Y 14 (Slide change) 15 MR. AYRES: We also say they should survey 16 both the device and the shielded patient treatment 17 facility because in the process of transport the shielding 18 could shift and we'd have a gap. That's the thinking 19 behind it. So if they first perform a baseline survey to 20 know what your radiation exposure rates are -- well, 21 first, you do it to the source housing, which is already 22 specified. Then, you run the source out and you perform a 23 survey around the shielding to ensure that the shielding 24 has not been compromised in any way during the transport 25 process. That's what it boils down to.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

187 l 1 Next slida. i 1

2 (Slide change)

3 MR. AYRES: Transportation -- now, as Larry 4 indicated in his draft there, in one of his items under 5 " transportable," this -- we now have to consider the 6~ possibility of accidents and other things that could  !

7 occur.

8 That simply is a reminder that a reviewer --

9 obviously, they have to comply with the DOT's 10 requirements, but it's a reminder because if we get 1

11 information in the license application that suggests this 12 application might be in violation of existing regulations 13 by DOT, we certainly shouldn't approve it with those O

x_- 14 violations, approve an application that violates other 15 regulations.

16 It must have the necessary DOT type 7 package 17 certification by the appropriate sealed source and device 18 sheets. And a reminder -- and we've issued some recent 19 article -- it comes -- relates to it in a similar way. If 20 you damage -- incur damage due to a vehicular accident, or 21 anything of that nature, there is no longer any assurance 22 that the DOT type 7A package's integrity may not be -- may 23 have not been violated.

24 We run into this problem with Moly-tech y ) 25 generators. If you have a defective generator, it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

188 1 cartninly doncn't most ths originnl cartification 2 requirements as a DOT type 7A package anymore. And if you 3 ship it, you're in violation almost very likely. So we're 4 saying in the event of an accident -- and we defined 5 " accidents" to include floods, fires, as well as vehicular 6- accident -- then the source safe needs to be rechecked to 7 ensure that it still meets the original requirement as a 8 safe DOT type 7A package.

9 Next slide.

10 (Slide change) 11 MR. AYRES: And the licensee should always 12 have a plan if something goes wrong that includes the 13 emergency response regarding any accident scenario. And 14 here is where we define an accident as a vehicle collision 15 or other event such as wind, water, or fire damage that 16 result in damage to the exterior or interior portions of 17 the mobile van or device used in transportable service.

18 And then we go on further to say we'd really 19 like to know about these, so any accident should be 20 immediately reported to NRC operations center and then 21 followed up by a written report. And this report would be 22 a description of the event, including the probable cause 23 and the manufacturer and model number, if applicable, of 24 any equipment that failed or malfunctioned as a result of 25 the accident, the exact location of the event -- next ff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000M701 (202) 2344433

189 l

1 slida. I (Slide change) 2

!m

\

3 MR. AYRES: This comes out of some existing i

4 regulatory guidance that we use in another area. The .

5 isotopes and quantities and chemical physical form of the 6' license material involved, date and time, corrective -

l 4 7 actions, extent of the exposure of the individuals. i 1

1

, 8 And then following any accident no treatment '

1 9 should occur until all safety systems pertaining to 10 radiation safety, including interlocks and device l 1

11 operation in accordance with manufacturer specifications i

p 12 have been tested and confirmed to be operational by either 1

13 what we consider one of the experts, the medical physicist

!. b/ 14 or the radiation safety officer.

3 15 And then all licensee personnel involved with 16 HDR transportation should receive the hazmat training as

\

. 17 specified in the DOT regulations. And they should carry '

18 calibrated and operational survey meter in the cab, not

! 19 keep both of them, or more if they have them, all in the i 20 van, such that there may be one survivable one to use for i

21 conducting surveys after an accident.

t

, 22 And I think I'll skip that slide there for the l

, 23 moment now. That concludes the summary of what we've 24 drafted as proposed regulations to authorize the use of C\

Q 25 mobile and transportable. We're open to any comments or 1

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20006-3701 (202) 236 4433

190 1 cuggsetion; you might have.

2 CHAIRMAN STITT: Well, Dan's looking my way.

3 MEMBER FLYNN: Just while you have that slide l l

4 up, it says " medical physicist or radiation safety i 5 officer." This is for an unusual event. Why not both? I 6 Because the radiation safety officer may not be 7 technically -- in an institution, for example, there are 8 some institutions with fixed HDR facilities where the 9 radiation safety officer has no real knowledge of the 10 technical aspects of the HDR machine, where the medical 11 physicist does. Maybe both, one from a technical point of 12 view, one from a licensee point of view, has to clear 13 rather than either -- either/or.

14 MR. AYRES: In current practices, I understand 15 it. And in many respects, this doesn't differ from -- in 16 this area from multiple site licensees. There is a single 17 radiation safety officer. There may be multiple mobile 18 vans. In other words, you would always expect a medical 19 physicist to probably be accompanying this, but not 20 necessarily the radiation safety officer.

21 In other words, if they have to cover a 22 territory of two or three vans they have a -- and it's a 23 single licensee, they have a single license and a single 24 radiation safety officer.

25 MEMBER FLYNN: Okay. The core issues I have NELAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200054701 (202) 234 4433

. . . --. . ... _ - . . _ . . . . ~ . - - - ._. .. _ - . . -

191 1 clways acon with HDR, since the Indiana, Pennsylvania '

2 accident, have been that -- that would prevent or minimize t/ 3 the risk of a problem would be the physical presence of "

4 the physician and the physicist at the console at the time '

5 of this treatment, which is a very brief treatment. .

6 Okay. Having survey equipment to be able to 7 survey the patie~t with portable equipment when the 8 treatment is completed, having emergency equipment which i

, 9 is minor equipment to remove a device, and having the i

10 experience and training with the device and with, let's 11 say, annual or periodic drills on emergency procedures.

12 MR. AYRES: That all applies. That all --

13 MEMBER FLYNN: Okay.

14 MR. AYRES: -- applies because what I said, 15 this is simply add-on to policy and guidance directive 16 86-4, which has all of those requirements.

17 MEMBER FLYNN: And then adding on the mobile 18 part of it, you already addressed the Department of 19 Transportation. Then I think of things such as, okay, if 20 there's a power failure, is there a power backup system?

21 Is there external communications with the medical 22 facility?

23 For example, in your Attachment 3, you talked 24 about having a written agreement with a (quote) " nearby

[\ 25 medical facility."

NEAL R. GROSS COURT REPORTERS AND TRANSCRWERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 23M

192 ]

1 1 MR. AYRES: Yes.

2 MEMBER FLYNN: And how nearby is nearby?

3 MR. AYRES: Well, that's why it's now out, and I 4 our guidance there --

5 MEMBER FLYNN: Is there direct communication i

6' between the internal -- the people inside a mobile 7 facility and the medical facility?

8 MR. AYRES: I hadn't considered -- and that's 9 a good point -- the emergency generator aspect of it, l 10 because although the HDR itself has battery backup -- all 11 of the current designs are designed that way -- certainly )

i 12 the cameras and the -- and some of the other devices do 13 not, although we normally -- we require a battery backup 14 for the room monitor, so we have two devices we require a 15 battery backup for but not -- that's all that we -- ,

1 l

16 MEMBER FLYNN: Okay. Because I looked -- you I 17 gave us a handout, a California -- Attachment Number 1.

18 It was a California license, and I have like three or four 19 comments on this. Should I make them now, or should I 20 just --

21 CHAIRMAN STITT: Yes, go ahead.

22 MEMBER FLYNN: Okay. I'm looking at 23 Attachment 1, and it's the -- I'm not picking on this 24 license. I'm just using it to illustrate --

25 CHAIRMAN STITT: Dan, tell us all again where NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 2344433 WA$dlNGTON, D.C. 20005 3701 (202) 234-4433

193 1 you are. Tell un --  !

2 MEMBER FLYNN: It's Attachment 1 for a mobile

_('

3 HDR, and it's radioactive material license. In this case, 4 it's Mobile Technology Incorporated with -- on page 1 of 5 7, like license conditions down -- license conditions down 6- below, it says, for example, "The radioactive material 7 will be used at the following locations." It cites a 8 specific hospital, and then it adds, " Hospitals as 9 temporary job sites throughout the State of California."

10 It's not specific in that regard. i 11 And then if you turn to page 2, it lists the 12 names of 73 physicians. I recognize many name= as

]

13 radiation oncologists, but 73 physicians is about 30 O

(, 14 percent of the radiation oncologists in the State of  ;

15 California on this one license. Then when I turn to the 16 next page, on page 4, it refers to a radiation safety 17 officer and a radiation safety committee, but I don't see 18 that there are authorized users experienced with HDR on 19 this radiation safety committee. And I don't see what the 20 relationship is between -- and this is not this company or 21 this license.

22 But what is the relationship between the 23 mobile facility and the medical facility which provides 24 the physicians in terms of the authorized user physicians,

) 25 the physicians' input into the -- let's say, the radiation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

194 1 ccfety. committee and the policies and procedures, because 2 on the next page -- page 5 -- item 23, I have a problem 3 with.

4 It says, " Written emergency instructions shall 5 be posted conspicuously at the remote after-loading device 6' control." It doesn't say who writes these procedures.

7 And " instructions shall include directions for doing" this 8 and that." And then " notifying the responsible 9 physician." Well, the responsible physician should be 10 standing right there by the console. I mean, you 11 shouldn't have to notify the responsible physician. He 12 should be the one that's right there in the midst of the 13 treatment. If there's a problem, he should be the one 14 directing the emergency procedures. He shouldn't be 15 telephoned.

16 MR. AYRES: Yes.

17 MEMBER FLYNN: He should be physically right 18 there.

19 MR. AYRES: Yes.

20 MEMBER FLYNN: There are other -- and I think 21 what can happen, in my own experience with HDR -- and I 22 want Judith to comment -- but for endobronchial treatment, 23 it's not --

I'm not so worried about the device breaking.

24 I'm worried about the patient who has a tube down their 25 nose who is having difficulty in breathing because they h NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

195 1 have a lung tumor that is constricting an airway, who is

(N 2 coughing, who is'short of breath, and the physicians s

v} 3 decide, not -- I mean, the physicians decide in that 4 facility, "Okay. We will have this patient on oxygen. We 5 will have a suction device right there. We will have a 6 portable cardiac monitor," which we do at Mass. General.

7 And these are all medical issues which kind of 8 mix in with the radiation safety regulatory issues, and I 9 don't --

and I don't see that the licensee, which is not a 1

10 hospital, has the experience and training to be able to i 11 write emergency procedures when they're so intimately l 12 integrated with the medical aspects of what might happen l

13 to the patient. If that patient stops breathing, who is 7-s )s 1

(  :

\- / 14 going to be there to make sure that the device is 15 retracted and the appropriate medical steps are taken?

l 16 And where is this nearby facility?

17 MR. AYRES: Right. I guess my response to you 18 there -- I was trying very hard there to stay out of the 19 practice of medicine by not getting into that area, with 20 the exception that they should have a plan. And a lot of 21 the things in the California license are covered under our 22 regulations that weren't maybe covered under California.

23 The problem -- and I have to apologize for 24 this because I still don't have the information -- there

( ,y 25 is a lot of detail in those letters that are incorporated NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

196 1

1 by referenca th t I do not hava acceen to.

2 MEMBER FLYNN: See, I don't think you should 1

3 get involved in the medical aspects, but I think -- it 4 seems like you are licensing a non-medical facility to 5 make medical judgments.

6- MR. AYRES: Well, under the supervision of the 7 authorized user, who should be making those medical 8 judgments, on whether or not it's appropriate --

9 MEMBER FLYNN: Not even on the -- I don't even 10 see that they're on the radiation safety committee, or 1

11 that they're even involved in writing --

12 MR. AYRES: Again, this is a single modality 13 licensee that wouldn't -- and not a medical institution. l 14 It wouldn't require a radiation safety committee. This 15 type of license would normally require a radiation safety 16 officer only and, of course, the other personnel --

L 17 medical physicist, the authorized users, and so forth. l l

18 MEMBER FLYNN: Who was making the judgment to l 19 add on the names of authorized users? And how was -- I l

20 mean, how are simple things like that -- )

l 21 MR. AYRES: That would be the customer, and l 22 they still have to provide us with the appropriate -- and 23 just as all of our other licensing, the appropriate 24 professional society certification or training and 25 experience to get those people authorized.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

.. . _. .- . . . . . . _ - . - -~ . . , . . . . _ _

197 1 MR. CAMPER: Just a couple of points to 2 clarify.

) 3 CHAIRMAN STITT: You're not next.

4 (Laughter.)

5 Well, I'll let you clarify. Judith is waiting 6 very patiently, and then we'll let you clarify.

7 MEMBER BROWN: Thank you.  !

l 8 I need more background than was provided in -l 9 the briefing book. I understand that you received your 10 first formal application, but are there any of these out l 11 there now?

)

12 MR. AYRES: Yes. In the State of California, j 13 none under our licensure. l

.,.)

14 MEMBER BROWN: Okay. And --

15 MR. AYRES: This is our first attempt.

16 MEMBER BROWN: -- is this a good idea?

17 MR. AYRES: Well, I don't see any problems 18 with it if properly done, like it's the capability of 19 providing a needed service which --

20 MEMBER BROWN: I mean, it makes me think of 21 the book mobile mode being applied to really complicate 22 things. And I'm wondering from this committee if they 23 think it's a good idea, and if there are things that a .

24 book mobile type atmosphere cannot provide in terms of C

25 patient safety.

(

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433 4

198 1 CHAIRMAN STITT: And, Judith, that'a why I 2 wanted you to speak next, because I knew you were going to 3 ask those questions. There are some real --

4 MR. AYRES: Yes. You're addressing the proper 5 audience, not me, about the --

6 CHAIRMAN STITT: No. There are some real 7 issues here. And the irony is that the issues that I have 8 are practice of medicine issues, and we just got through 9 having this handed out to us, that the NRC's role is not 10 to practice medicine. And I think what you've done is to 11 try to look at what we have on the books and how does this 12 relate.

13 Let me tell you a couple of examples, and then 14 Dan may want to toss out some things, as well as our GI i l

15 physics friends. My understanding of what the NRC is 16 specifically looking at is actually the mobile device.

17 Okay? Let me just take that as an example, because they 18 give us nice pictures. But there is the mobile facility, 19 and there's a mobile device.

20 Institutions that I'm familiar with who want 21 to be able to use a mobile device, for example, might be 22 in Detroit Harper Grays Hospital is just down the street e 23 from Receiving, and there are some other just 24 geographically coordinated hospitals that are all served 25 by the same physicians. And it would be helpful if they h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

199 1 could buy ons HDR d0vice that you can take to each of your f-'s l

2 four facilities and your highly trained people use them in

(

\#

3 a very -- it's just a different way of taking your medical 4 doctor bag with you.

5 And to me, that's a different thing, and I 6' love your book mobile approach, because when I first saw 7 it --

in fact, I've got a slide of it in the slides that I 8 use for discussions, and it usually kind of evokes gasps 9 from the crowd because it is a, you know, "have source, 10 will travel." And I think some of the comments that Dan 11 brought up are very -- are the alarming medical issues.

12 Intraluminal therapy -- if you've put a source

,, 13 in a lumen somewhere, and a patient has a problem or a k/s 14 source comes disconnected, it's a bad enough circumstance 15 in your own institution, and I can't imagine how you would 16 handle that with a letter of agreement saying that, "Yes, 17 we think a surgeon somewhere said that he would go in and 18 crack a chest and try to retrieve the source."

19 But these are practice of medicine issues, and 20 I think they are -- I guess it didn't surprise me --

21 nobody is from California. We lost Dr. Berman. It didn't 22 surprise me that California was the state that came up 23 with the --

22 MR. AYRES: We do have the president of the ,

O 25 company --

l I

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006 3701 (202) 236 4433

200 1 CHAIRMAN STITT: All right.

2 MR. AYRES: -- in the audience if you -- p 3 CHAIRMAN STITT: It still doesn't surprise me, 4 because medical practice is just very different in 5 California.

6 I think that the NRC can't license the 7 practice of medicine, but I think there are some very 8 enormous safety issues that it brings up.

9 MR. AYRES: Yes.

10 CHAIRMAN STITT: Now, Naomi, do you want to 11 make a comment? Or do you still want to make your 12 clarification, Larry? Will they really clarify something?

13 MR. CAMPER: Yes. Just three things quickly.

14 One, this licensee has chosen to develop a radiation 15 safety committee. In our regulations they would not 16 necessarily have to have one.

4 3

17 Number 2, the physicians that have been added 18 are being reviewed by the State of California. They would 19 be reviewed by us as well. Unless we were to condition 20 this committee to be able to review and approve -- that's 21 a question which we have to explore. You know, as you now 22 know we let broad scope licensees review and approve 23 credentials of -- the question is, would we let this 24 licensee do that? That's a condition we have to consider.

25 MR. AYRES: Which is not a broad scope.

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

'l 201 )

l 1 MR. CAMPER: That's right. It's not a broad l 1

,f-'s, 2 scope licensing.

N,~'A 3 And the third one is with regards to item 23 4 on page 5. While I do not know if the State of California 5 requires that the therapist be physically present during l 6' the HDR procedure, we do. One can read these instructions 7 and get the impression that they do not have to be 8 present. However, I do know that in the State of 9 California, when doing radiation therapy -- say, for 10 example, with iodine-131 -- the physician has to be 11 present.

12 So that's not to say ths; that's not the case

,_, 13 here as well. But I can see why you might have that s_, 14 interpretation as you read the instructions.

15 MR. AYRES: Yes. I think the -- I'd made a 16 comment. I tried to restrict myself to radiation safety 17 issues. As far as transporting this type of device, there 18 is little difference between that and, say, radiography 1 19 which is transporting an even higher activity device. The 20 additional concerns is in taking extra care to ensure the 21 device is performing properly when it gets to the location  !

22 because patient treatments are involved. l l

23 I would also comment that the president of the 24 company that applied is in the audience, if you wish to 25 direct any specific questions about the practice in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006-3701 (202) 234 4 433

202 1 California, which I am not totally familiar with. My 2 understanding is they have had a pretty good safety record 3 up to this point, and they have been operating several 4 years. They have had -- there has been one l

5 misadministration that I'm aware of, and that's the total 6 extent of the problems that the Service has encountered.

7 CHAIRMAN STITT: Naomi had a question, and I 8 then I'll --

9 DR. ALAZRAKI: I have two questions. First, 10 doesn't the FDA have to approve all of these devices? l 11 MR. AYRES: That's correct. They have l

12 510 (k) s . Both of the currently-approved devices have been '

l 13 subjected to 510 (k) reviews prior to, I believe, the 14 safety evaluation and the sealed source device listing.

15 DR. ALAZRAKI: So the FDA has, therefore, 16 determined that the device is safe and effective --

17 MR. AYRES: That's correct.

18 DR. ALAZRAKI: -- for patient use.

19 MR. CAMPER: And the State of Maryland has 20 issued a cert. sheet, which means that the device is safe 21 to use in the mobile configuration --

22 MR. AYRES: Right.

23 MR. CAMPER: -- as authorized.

24 MR. AYRES: And NRC has done the same thing 25 for the transportable device.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 2000 5 3701 (202) 234 4433

-. . - - - . . - - . . . . - . . . . - - - - . . .~ _ . - . ~ . -

-203 i- 1 MR. CAMPER: That's right.

i .- _2 DR. ALAZRAKI: And then my other question was i

3 about your remark. Isn't there an understanding between 4

4 the NRC'and the agreement states that the agreement state l 1

4 5 regulations will be at least as stringent as those of the 4

3 6 NRC but not less so?

7 MR. CAMPER: Actually, no, that's not quite ,

l 8 right. j 9 DR. ALAZRAKI: No?

10 MR. CAMPER: No. What happens is, as each 11 regulation is promulgated that impacts Part 35, a level of 12 compatibility.is assigned to it. With the exception of 13 the quality management rule, which carried with it a 14 level 2 compatibility which means it has to be at least as 15 restrictive as --

16 DR. ALAZRAKI: Okay.

17 MR. CAMPER: --

and the radiopharmacy rule, 18 which carried compatibility levels 1, 2, and 3 with it.

19 The definitions were division 1, which meant they had to 20 be verbatim. Most of the rule was division 2, 21 compatibility. Some of it was division 3.

22 The rest of Part 35, very little is 23 compatible. Most of Part 35 is not an item of 24 compatibility, with those exceptions.

25 DR. ALAZRAKI: In other words, with regard to NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

204 1 radiction thsrapy, en cgrc:m:nt etato can hnvc lesa 2 stringent requirements than the NRC does?

3 MR. CAMPER: I would have to go back and look 4 specifically at the compatibility requirements that were 5 put in place, for example, in the 1979 change in 6 teletherapy. But with the exception of the quality 7 management r'ae and the radiopharmacy rule, very little in 8 Part 35 is an item of compatibility.

9 MR. AYRES: And on this, this is not even 10 regulation. This is simply licensing guidance, so is no 11 way binding upon the states, although getting into some 12 uniformity would greatly assist in reciprocity, which is 13 another issue, and particularly with a mobile service.

14 CHAIRMAN STITT: Comments over here. Go 15 ahead, Theresa.

16 MEMBER WALKUP: What are your security 17 measures i'or the storage of this whern it's not in use? I 18 noticed you said when it's at the client's location that 19 -- where does it go at night?

20 MR. AYRES: Well, we didn't -- I didn't 21 specifically address that issue. That may be something we 22 should look at a little harder.

23 MEMBER BROWN: Okay. We just had a bus 24 hijacked in Baltimore last month off a lot, so --

25 MEMBER FLYNN: I think there's an identified NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE N.W.

(202) 2 % 4433 WASHWGTON, D.C. 2N3701 (202) 2344433

.. .- .. - - ~ - .- -. - - - .. -- _-

1 I

205

l 1 parent facility where it's in the licensing -- i 4

2 MR. AYRES: But it could remain overnight at a I

) (d 3 client's site easily.

l 4 MEMBER FLYNN: Right.

5 MR. AYRES: We have some security requirements 6 in FC 86-4, which basically says it's locked and the key )

a i 7 isn't available for the device. But --

i

)

8 MEMBER WALKUP: It needs to be, though, where 3

9 it can't get hit by a truck. I mean --

t 10 MR. AYRES: Well, we specified that already, {

11 and it would presume -- well, that maybe needs some more .;

I l 12 detail. Okay. That's -- I 13 CHAIRMAN STITT: It gives a new meaning to

( ,

14 that ad-you see on television, " Parents, do you know where J

15 your children are tonight?" I 1G MR. AYRES: Yes.

17 CHAIRMAN STITT: Do you know where your 18 sources are?

19 Jeff and then Lou.

I 20 MEMBER WILLIAMSON: Yes. I have a number of 21 specific comments. You know, I appreciate you're having a l 22 difficult time steering between what are bona fide safety 23 issues and what are medical issues. I really agree with 24 both Judys that there is some -- I personally would have 25 some concerns if I were a radiation oncologist using this NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000E1701 (202) 234 4433

206 1 davica.

2 As I understand it, it can be set up sort of 3 as a book mobile where the parent service provides the 9l\

4 physicists, the treatment planning protocols, and i

5 everything, and there is sort of no ability for the l 1

6 radiation oncologist --

or diminished ability for the 7 radiation oncologist and the physics dosimetry team to l

8 sort of develop kind of a good working relationship where 9 it's clear that the dosimetrist and physicist are 10 providing exactly what the physician wants.

11 There could be miscommunication about 12 criteria, dose specifications, and any number of things.

13 But I think that's really a medical issue. I think if, 14 you know, a radiation oncologist doesn't want to, you 15 know, follow those kinds of guidelines, I'm not sure it's 16 the appropriate place in this kind of regulation to have 17 it.

18 So as I read it, I have some, you know, 19 concerns -- one question in Section 3.2. So what business l 20 is it of NRC whether, you know, the institution -- client l

21 institution has signed an agreement to provide emergency ,

l 22 medical care if the patient has a heart attack? I mean, l l

23 it's a concern for patient care, but why is it a concern l

24 of the NRC any more than if a mobile mammography unit came j 25 by? That's -- I have questions like that.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W. .

(202) 234-4433 WASHINGTON. D.C. 20005 3701 (202) 234-4433 )

1 1

207 1 MR. AYRES: It's not the client institution.

/N 2 It's the licensee that -- or the applicant that we expect t

3 to have that kind of agreement. In other words, provide 4 -- to address that issue in a cursory manner that some of 5 you have raised. Maybe we went too far. That was an item 6 that I figured we got --

that I thought we got as close as 7 we -- in this document to the practice of medicine as we 8 got right there.

9 MEMBER WILLIAMSON: Why can't you just, you  !

l 10 know, sort of leave it that I think, you know, the safety 11 concern is specific to the fact that this procedure i

12 involves a radicactive source, as if it breaks and gets

-, 13 stuck in the patient. And a performance-based criterion

\m- 14 might be: you'd better have some method at each client 15 institution for, you know, making sure you can reasonably 16 extract that thing.

17 MR. AYRES: Right.

18 MEMBER WILLIAMSON: And leave it to the  !

l 19 institution -- or, rather, the mobile company -- versus I 20 each client institution to develop a medically acceptable 21 plan.

22 MR. AYRES: Well, that's awful close to what 23 is said there. We just said you need to have some sort of 24 an agreement to address the issue.

( j 25 MEMBER WILLIAMSON: You say a written NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON, D.C. 20005 3701 (202) 23 4 433

208 1 agrccmcnt, plud alco a written agrecmcnt to provida 2 ancillary medical emergency services that have nothing to 3 do with the source breakage.

4 MR. AYRES: Okay. I recognize that one --

5 that one was the closest we took a brush with the practice 6 of medicine, but --

7 MEMBER WILLIAMSON: I would just say it 8 doesn't seem reasonable for you to be involved in that.

9 MR. AYRES: Yes.

10 MEMBER WILLIAMSON: You know, I -- other 11 things I guess, questions occurred to me, would be the 12 licensee, as I understand, is the company that owns the 13 mobile facility. Would they be like a radiation safety 14 committee of a broad scope licensee, and they could, 15 without specific license amendments, add and delete 16 physicians from their rosters of an authorized user?

17 MR. CAMPER: I just addressed that, yes. I 18 just commented on that.

19 MR. AYRES: Yes. And as this is written, it's 20 with the understanding, particularly of this license and I 21 would envision most of them, to not fall under the broad 22 scope class of occasion of a license, that it be limited 23 specific for that type of application, and no, they 24 wouldn't have the authority.

25 MR. CAMPER: That's right. I don't know -- my NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 2tXN3'/01 (202) 234 4433 j

209 1 ascumption i= is that California ctill revicwa each of i g m. 2 their physician applicants. They have not given them the i .

3 broad license condition, if you will, to name their own l 4 users, although the organization has created a committee.

1 5 We would not do that, because we do not view this licensee '

l 6 as a broad scope institution. l 7 MR. AYRES: I guess in summary, I would see 8 some pluses and minuses to this. What I would see is 9 these services going te those facilities that don't 10 perform this type of treatment very often. By doing so, i 11 they provide a highly experienced and competent staff, in j l

12 terms of dosimetry, treatment planning, physicists, and so l l

7_.

13 forth. On the minus side, the authorized user probably l f )

K/ 14 doesn't practice these procedures very often, so you have 15 one-half of the team that are very proficient and the 16 other half or another component that doesn't do this type 17 of thing. And that would be something that you could 18 address.

19 MEMBER WILLIAMSON: And, you know, in my 20 remarks I'm agreeing with you about the philosophy that 21 that's a medical practice decision, and it's sort of hard l

1 22 to call. I agree.

23 In Section -- is it 11.20.2.3.1? -- you talk 24 about the quality assurance that must be performed each

/

( ,

\

! 25 time the unit is moved?  !

\_ / j NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20W701 (202) 234 4 433

210 1 1 MR. AYRES: Yes.

2 MEMBER WILLIAMSON: Remind me what specific 3 things in the 30-day protocol you are requiring that be 4 done.

5 MR. AYRES: I'd have to have the list in front  ;

6' of me to be sure. About the only thing we deleted was, 7 like I said, the catheter length. But it's the stepping 8 accuracy, the timing, the interlocks, the indicator 9 lights, and so on and so forth, the normal -- 30 just goes 10 -- just has a couple of additional items, and I think i 11 that's the timing and the source position accuracy.

12 MEMBER WILLIAMSON: Yes. I would, you know, 13 try and make it --

14 MR. AYRES: Beyond the daily. G,,i 15 MEMBER WILLIAMSON: Yes, I understand. Okay. l l

l 16 Well,. I'm glad you've withdrawn the treatment tubes. And i

17 also, do you think really to insist that a complete  !

i 18 facility survey be done every time the truck moves is 19 necessary? That's what I understand.

20 MR. AYRES: Complete enough to ensure that the 21 shielding hasn't been degraded in some way. It's a bolted 22 together lead cave.

23 MEMBER WILLIAMSON: Right. But, I mean, do 24 you -- is there evidence of risk to suggest that the thing 25 is going to fall apart just by being driven under normal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.

(202) 234-1433 WASHINGTON. D.C. 20006 3701 (202) 234 4433

211 1 conditions from point A to point B? And wouldn't maybe a {

f-'s 2 quarterly check, which they have to do anyway when they k

3 replace the source, be a sufficient baseline condition, I 1

4 just based on risk versus benefit?  !

i 5 MR. AYRES: Well, you're right into the risk 6 issue. I would construe this as a high risk if there was  !

7 a gap in the shielding.

8 MEMBER WILLIAMSON: There's a high probability 9 that there will be a gap in the shielding?

10 MR. AYRES: No, low -- but it's -- how do you 11 mix the probability versus the level of risk? Somewhere 12 you're going to come up at some decision point, and I made 13 the decision point at this point. Where should it be?

O k,s 14 You know, I'm saying the risk is sufficient enough, even 15 in the event of a low probability, but we don't have the 16 operational experience to determine what that probability 17 is.

I 18 MR. CAMPER: That's right. This is an 19 emerging technology, and we do not have the operational 20 history yet. At some point, maybe we would spread the 21 timeline based upon operational history.

22 MEMBER WILLIAMSON: Well, it just doesn't seem 23 really to be very much in accord with their sort of 24 announced new philosophy.

25 MR. AYRES: But a discrete type of lead cave, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

212 1 the survay of, nhould bn a rathar non-burd:nnome process 2 also. It's not like having to go around corridors and 3 rooms permanently shielding l

4 MEMBER WILLIAMSON: And my last comment is l

5 Section 13.3 on I think the second-to-the-last page. I 6- don't think most radiation safety officers are competent 1

7 to assess the operational capability of an HDR system.

8 MR. AYRES: Right. An event.

9 MEMBER WILLIAMSON: They do not have the 10 professional training, and I would --

11 MR. AYRES: Okay.

12 MEMBER WILLIAMSON: -- delete the radiation 13 safety officer from the --

14 MR. AYRES: Okay. We deleted them elsewhere 15 in our revised 84-6.

16 CHAIRMAN STITT: Lou has comments.

17 MEMBER WAGNER: Well, I just wanted to get 18 back to Judy's comment, because I thought it was a very 19 good comment regarding whether or not this is a good idea.

20 And I think we have to address the issue from two l l

21 different points.

22 Number 1, is it a good idea for public safety, 23 people who are going to be walking around it, people who 24 might be in the vicinity, and for the public in general?

25 And then you have to address it from the patient issue.

NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 23W33 WASHINGTON, D.C. 20005-3701 (202) 23M

213 1 And I would egrca almost entirely with a lot of the l

l 3 2 comments Jeff made earlier about the fact that you're

( )

N s' 3 trying to separate patient-oriented issues from the 4 public-oriented issues. And it's a good comment, in the 5 sense that is it a good idea for the public in general.

6- Well, it can be managed. Anything can be 7 managed. Given enough conditions to control it, it can be 8 managed. And whether or not there could be a situation j 9 where there might be an accident that could cause exposure 10 to the public, to these high dose rate sources, that would 11 be the issue that would be of grave concern. And I think 12 that that has been pretty well answered, and that's where 13 we should be addressing here.

A k,) 14 In response to what you've been saying, 15 Judith, that there's a lot of medical issues, yes, but I 16 don't think this is the forum to discuss it. This is -- l 17 the medical issues have to be addressed by the physicians, 18 and I think the whole idea with our point of view is that 19 the physicians have to be qualified sufficiently to be 20 able to handle this pioneering-type technology and to make 21 the appropriate decisions, and make the appropriate 22 judgments regarding personnel that must be on board, 23 precautions that must be taken, in order to provide the 24 most adequate benefit to the patient.

fs_ / 25 But those are medical issues, and that's where 3

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON, D.C. 20006-3701 (202) 23 4 433

214 1 I think wa've got to provida our councal hors in regard to 2 separating those medical issues from the patient --

from l

3 the public safety issues.

4 MR. AYRES: I see that as an ideal issue for 5 the professional societies to address and perhaps provide 1

6- guidance on.

1 7 CHAIRMAN STITT: Exactly. And that certainly 8 is one of the items that the commission has put on their 9 list of views they'd like from us.

10 Other comments specifically on this? Dan?

11 MEMBER FLYNN: Well, getting back to the 12 medical aspects, if you stick with the radiation aspects 13 my question is -- and I don't know the answer to this 14 question. In California or in any state, if you have a l 15 medical facility -- and let's say the medical facility is 16 mobile -- and if medical treatment occurs within the walls $

17 of that mobile facility, whether it's suctioning oxygen or 18 -- decisions are made inside the walls of that facility, 19 which are basically medical decisiens.

20 Are you saying that this -- wi.ct happens 21 within the walls of this mobile facility is purely an NRC 22 issue? Because I see it as if there are agencies that 23 license medical treatment facilities, that they also have 24 a vested interest in the --

25 MR. AYRES: No. The NRC issue is clearly the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 2344433

215 1 radiation aapset. Clearly, this licensee, unlike in the fg 2 State of California which handles both, since they're

' U 3 operating in our agreement states, they're going to have 4 to go to the individual states to license that' simulator.

5 We don't handle that. That's outside of our purview.

6 So those other kinds of issues like that have  !

7 to be addressed when --

I 8 MEMBER FLYNN: See, the emergency treatment --

9 the implication of reading this is that emergency medical i 10 treatment occurs within the nearby facility. But

(

l

. 11 actually, medical decisions are being made within the 12 walls of this treatment facility 13 MR. AYRES: Oh , I understand.

.O

' ( ,) 14 MEMBER FLYNN: You have to understand, it's  :

i 15 not the hospital that is making those decisions, and it's

{

16 not necessarily the physicians who make the decision. If 1 17 there are -- my question is, is there an agency -- is it a 18 state agency or is it a government agency -- which license i 19 mobile medical facilities, not radiation facilities, but 20 just mobile medical facilities? And I don't know the l 21 answer.

22 MR. AYRES: This committee can better address 23 that than I. I mean, there are existing facilities like 24 Lithotripter that is a therapy facility that is operated 4

I 25 on a mobile basis.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

216 1 CHAIRMAN STITT: John hac c comm:nt.

2 MEMBER GRAHAM: Yes. I can't answer for the 3 entire country, but the majority of this type of a 4 facility would be licensed through a state. It's the same 5 regulatory group that handles the licensing of hospitals.

6 So a portable MRI has become a very well-accepted 7 approach. It is the only way that you can get current 8 routine technology to small hospitals who couldn't afford 9 it otherwise. So it's an access issue.

10 I think it is driven at a state level, 11 frequently with discussions that it is better to have a 12 team that has done it many, many times a day, because they 13 are moving around, then having something parked in a 14 facility where somebody is only going to do it twice a 15 week.

16 In followup to the comment, I would completely 17 delete the statement about the medical care. If this 18 thing needs to be licensed in a state, that's an issue 19 that ought to be discussed under the control of the 20 delivery of medicine in that state. The most analogous 21 example that we've gone through in Michigan is 22 angioplasty. It's easy to do angioplasty. The question 23 is, who is going to crack the chest and patch the heart if 24 you pop something?

25 MR. AYRES: I would agree with you --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

217 1 MEMBER GRAHAM: I don't think wa ought to get

,- 2 into it. The only specific thing I had. on this review --

\

\~ ') 3 if you're going to get into the issue of transportable 4 HDR, I would clearly want identification of the 5 alternative use of that room when it was not being used 6- for this.

7 MR. AYRES: Well, I didn't have to keep my j i

8 slides in a manageable order, but I thought I had it in 9 the documentation -- clear that, again, whenever it's 10 being used by the mobile facility, they have -- part of 11 this agreement that they supplied us to get the license 12 ensures that they have total control of that facility at i

13 least during their period of use. i 14 MEMBER GRAHAM: I understand during, but I 15 would lean towards defining what they use it for during 16 the off periods, simply to make sure that they're not 17 doing something in the room that could degrade the 18 integrity of that room when that HDR comes back in.

19 MR. AYRES: Well, except we expect full 20 operational checks on reinstallation. Maybe we should go 21 further. That's --

22 CHAIRMAN STITT: Well, usually -- I mean, 23 about the only thing I can think of that it would be used 24 for would be a treatment room. It's an accelerator room 25 for the most part.

(-']s g

s .

NEAL R. GROSS COURT REPORTERS AND TRANSCRI8ERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

218 i i

1 MR. AYRES: Often whnt h ppans is thoro'o e l 2 lot of unused teletherapy rooms setting around because 3 they have discontinued teletherapy, the room is too small 4 to put an accelerator in, and that's the kind of spaces i 5 that would be often occupied by these. j 6 CHAIRMAN STITT: Dan, you have other comments 7 to make?

8 MEMBER FLYNN: Yes, the last couple. Getting  ;

9 involved with the medical aspects again, and keeping it 10 separate, but, for example, my understanding is that the 11 mobile facility keeps the medical -- keeps the radiation 12 records. It's important also that the hospital, the 13 individual clients I guess you'd call them, because we're 14 mixing teletherapy with low dose rate brachytherapy, maybe 15 with an HDR brachytherapy procedure, that all of the 16 radiation records for patient care, I think maybe there 17 has to be dual records.

18 MR. AYRES: I think so, because the licensee 19 is responsible under the quality management rule to do 20 these periodic reviews. So they've got to have the 21 records necessary for that.

22 MEMBER FLYNN: And then my last comment --

23 MR. AYRES: And clearly, those belong to be 24 part of the --

25 MEMBER FLYNN: My last comment is just using NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

219 1 this californic license as an example -- in paragraph 36 g) 2 and 37 right at the very end. I'll just read it. It V 3 says, 36 says, "When engaged in providing mobile radiation 4 therapy services to non-licensed customers, the licensee 5 shall retain all responsibilities for the use of the 6- reactor material authorized by this license." I'm not 7 sure what a non-licensed customer is.

8 MR. AYRES: Well, it's irrelevant to us, i

9 because we hold the licensee responsible for the whole l 10 thing, whether the customer is licensed or not. For those 11 things which they are authorized to do, they are 12 responsible for, and whether the customer has a license or

~~ 13 not is irrelevant.

V 14 MEMBER FLYNN: Okay.

15 MR. AYRES: So I read the California license, 16 and we got very little benefit out of'what was available 17 in that, and partly because a lot of the detail was also 18 missing, which I think we had in our application.

19 And you mentioned one thing -- I didn't put 20 the slide up, because I didn't want to take a lot of time.

21 But just -- this is one of the reviews of the deficiencies 22 in the application. And, in fact, in item 5, I addressed 23 exactly what you said. I said they didn't provide us with 24 enough information on their procedures -- normal and

'A

( ) 25 emergency -- and they need to flesh that out. And it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433 1

220 l

l 1 needs to be cp;cific to their opsrstion and not the l 2 operator's manual, the procedures manual that is kept at l

3 the console. But we look for those. That's part of the l

4 FC 86-4.

5 MEMBER FLYNN: But you didn't address -- did 6- you say that you didn't look at the power backup? And 7 also, the communications between this mobile facility, if 8 you have a radiation emergency, let's -- okay. I'm 9 thinking in terms of medical emergency, because that's 10 what is going to happen. But you don't want to talk about 11 medical emergencies. Let's talk about a radiation 12 emergency, a radiation incident that requires some 13 additional help. Is there communications inside this 14 mobile facility with the nearby medical facility?

15 MR. AYRES: Okay. Well, two problems there I 16 see. One, I disagree a little bit about taking the 17 medical out entirely. I think --

18 MEMBER FLYNN: No. I --

19 MR. AYRES: I think it should go down to the 20 radiation emergency, medical-related situation, and leave 21 that part but take the other part out.

22 But under the current scenario I wrote this 23 for, the client might be a clinic. It might not be able 24 to provide -- that's why I said nearby -- might not be 25 able to provide the necessary services. Should we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000N1701 (202) 234 4433

. . - . _ _ ~ .

i

! 221 1 restrict it to a mndical institution that can provide d

2 those emergency services? Those could be the only iV 3 customers? That's one possibility.

! 4 But they could be providing -- I could 5 envision this service being provided to a therapy clinic 4

6 that only had an accelerator, for example. There is a lot 7 of those that treat it on an out-patient basis with linear 8 accelerator, such as many of the facilities or one of the 9 facilities you looked at several years ago.

10 So right now this doesn't restrict the clients 11 to medical institutions.

12 CHAIRMAN STITT: We're going to break at 2:45,

,_s 13 and we will be right on schedule. So kind of keep that in i

Nm 14 mind as we keep our discussions going.

15 Jeff, you had comments?

l 16 MEMBER WILLIAMSON: Just a point of 17 clarification. What defines -- the licensee would be the 18 organization that owns and staffs the truck with the 19 mobile HDR unit in it.

20 MR. AYRES: Right.

21 MEMBER WILLIAMSON: What defines the 22 qualifications of their radiation safety officer and 23 radiation safety committee? You may have mentioned it, 24 but I missed it in the information --

O (j 25 MR. AYRES: Our normal regulations that are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

222 l

1 reviewsd in ac'cordance with ths --

2 MEMBER WILLIAMSON: So that would be depending 3 upon whether the company has a license of specific scope l 4 or broad scope that that would define?

5 MR. AYRES: Right. And I don't envision this 6- type of operation reaching a broad scope criteria, at 7 least any time soon, if for no other reason they are a new 8 type of facility, a new license, and we don't issue a 9 broad scope license to a new licensee.

10 MEMBER WILLIAMSON: A university medical 11 center could have a broad scope license and choose to 12 provide mobile HDR for their satellite facilities. And I 13 guess they would then add this on as an amendment to their 14 broad scope license. <

15 MR. AYRES: Yes. But they have the experience 16 and the authority to name the users in that situation 17 and --

18 MR. CAMPER: That's correct. Yes, they could.

19 And similarly, this organization or another type of 20 organization that had developed a radiation safety 21 committee, that had the right types of expertise, could 22 solicit the agency for such authorization, and then we'd 23 have to view it and consider whether to give it to them or 24 not.

25 MEMBER WILLIAMSON: Well, anyway, please f NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000k3701 (202) 234 4433

.- - _ _ _ . - -- - .- - . _ .- . . . ~ . -

223 1 romind mm for the epscific license what would be the

,fss 2 requirements for radiation safety organization and ,

'(\~ '

)

^

3 structure for the mobile license holder.

i l

4 MR. AYRES: A radiation safety officer, and '

5 then we have the usual requirements. During treatment we i

6- have the medical physicist and authorized user present. I 7 would presume since the licensee is entirely responsible, 8 I presume the authorized users would be under some sort of l

9 employment contract with the licensee. In other words, he  :

10 is responsible for them, the license is responsible for {

11 them, no he needs to ensure he can maintain that.

I 12 As far as the radiation safety aspects go, the 13 medical issues are between the state and-the normal l'

k 14 medical practice. We're not getting into that one. l 15 CHAIRMAN STITT: Other comments? Looks like l

16 the eyes are glazing over. '

17 (Laughter.)

18 Must be lunch.

19 Dan? John? Any other questions you have for 20 the group about your new -- ,

21 MR. AYRES: No. I appreciate some of the 22 feedback. If anybody wants to give me their written 23 comments, I would appreciate that. Otherwise, I'll wait 24 until the abstract is out and dig out the comments, 25 because obviously I couldn't take copious notes here.

J NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

224 1 But this is a very real-tima davelopm2nt 2 process right now, and we're hoping to get it out without 3 delaying it significantly. So we need to keep moving on 4 it. That's all.

5 CHAIRMAN STITT: All right. Then let's break 6 until 3:00. At 3:00 -- everybody has the medical policy 7 statement. We have, I will say, until 4:15, 3:00 to 4:15 8 to go back and rehash the discussions we have been going 9 through today.

10 (Whereupon, the proceedings in the foregoing 11 matter went off the record at 2:45 p.m. and went back on 12 the record at 3:07 p.m.)

13 CHAIRMAN STITT: It's 3:00. Why don't we al.'.

14 get seated and get started.

15 We've got everybody but the staff. Come on, 16 you guys. Right. We're wanting to work. You're goofing 17 off.

18 All right. Everybody kind of warmed up, l 19 refreshed, ready to roll? l 20 My plan would be work from 3:00 to 5:00. It's 21 written with no break, so you can go stand in the back of 22 the room to shake out your leg cramps, but let's just work 23 from 3:00 to 5:00. Okay?

24 And the issues would be we have to leave, 25 what, 45 minutes at the end for the --

lh NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344 433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

225 1 MR. CAMPER: Yes. About the status reports?

p v <

2 CHAIRMAN STITT: Yes.

3 MR. CAMPER: About that, yes. About 45 4 minutes, yes.

5 CHAIRMAN STITT: Okay. So we have the next 6 hour plus.

7 Sally passed out the medical policy statement, j 8 and the points 1, 2, and 3 are pulled out of the attached.

9 rules and regulations, and she has for a previous event 10 summarized them there. They are in that document.

I 11 I think everybody has had a chance to go over l l

12 those. And if we can pick up where we left off, we can be '

13 looking at this as background. And who wants to start l

_ 14 off? We need to continue to put on the record comments 15 that we have about the issues that the Commission has 1

16 asked us to feedback our consultants' advice, specifically j 17 guidance on low risk medical activities, guidance on 18 implementation methods of revising Part 35, and the 19 options 1 through 5 that we sort of continue to float in 20 and float out on.

21 Dr. Lou, why don't you go ahead.

22 MEMBER WAGNER: I seem never to be too shy 23 about these things.

24 Yes. I'd like to address this, because I'd Q 25 like to read these three items. I'd like to read them and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE, N.W.

(202) 234 4433 WASHWGTON, D.C. 20006-3701 (202) 234-4433

226 1 then addrarc thnm.

2 Now, this policy statement was -- originated 3 in February of 1979. Is that, correct? "The NRC will 4 continue to regulate the medical use of radioisotopes as 5 necessary to provide for the radiation safety of workers 6- and the general public." That's number 1.

7 "The NRC will regulate the radiation safety of 8 patients where justified by the risk to patients, and 9 where voluntary standards or compliance with these 10 standards are inadequate."

11 "And the NRC will minimize intrusion into 12 medical judgments affecting patients, and into other areas 13 traditionally considered to be a part of the practice of 14 medicine."

15 So those are the three statements, and I guess i

16 I would raise the issue: let's look at regulations on --  !

17 for example, take misadministrations of diagnostic doses i 1

18 of ionizing radiation. Where is the risk here? It says 19 it has to be justified by the risk. Where in the world is l 20 the risk if there are misadministrations even of the level 21 that are currently defined? Where is that justification?

22 And I question where in tnc world it ever was. Is there 23 any record of what justification was given for that?

24 Because I certainly don't know of any. "And where 25 voluntary standards or compliance with these are h NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

227 1 inadequate," it says.

p 2 Let me give another issue. It says "where 3 justified by the risk." Let's take just a simple 4 regulation, the AIARA principle. The ALARA principle s' regulates against dose administrations or levels of 6- radiation for which there is no evidence that there is a 7 risk. It takes things down below those conservative 8 levels which.were justified -- which.were stated as safe 9 by the NCRP and the National Academy of Sciences, not 10 stated as safe but stated as conservatively below those 11 levels where we know that there are some risks involved.

12 So we're already at very low levels, and yet 13 we apply this ALARA risk which takes it even lower levels 14 -- levels to which we have no real good evidence that 15 there are any risks. So there is a lot of regulation that 16 I see that exists for which I don't see the. justification 17 based on risk for those regulations. And I guess that's 18 where I want to start.

19 Naomi?

20 DR. ALAZRAKI: Basically, I would agree with 21 that, as long as the handling and administration of 22 diagnostic doses is by trained, appropriately trained 23 personnel and individuals. And, of course, the NRC should 24 be concerned with the handling of doses and preparation of 25 doses. But as long as trained individuals are involved, I

- NEAL R. GROSS COURT REPORTERS AND TRANSCRBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2hn WASHINGTON, D.C. 20006-3701 (202) 2344433

228 1

think tha rick io co minimal that tharo chould not be any 2 regulation of that practice of medicine.

A 3 CHAIRMAN STITT: Can we continue on that topic Wl :

I 4 of what we look at as being low risk? Specifically, let's 5 talk -- continue our discussion on diagnostic. i 6- Jill?

7 MS. LIPOTI: The medical policy statement --

l 8 1, 2, and 3 are excerpted from what is a more general l 9 discussion that appeared in the Federal Recister in '79.

1 10 And I'm going to read from that, and it's a belief of the 11 Commission. This is on the third column on the second 12 page. "The Commission believes that the diagnostic use of 13 radioactive drugs is, in most cases, clearly an area of ,

14 low radiation risk to patients." Right there, that '

15 Commission, in 1979, affirmed that believe. We didn't 16 even have to wait for a new Commission. l 17 (Laughter.)

18 MEMBER WAGNER: This is getting to be a very 19 strong case here.

20 (Laughter.) )

21 MR. CAMPER: Well, but let's continue the 22 dialogue. That's an excellent point. Thank you. Let's 23 read on what it says and then try to pick up what is 24 happening.

25 It goes on to say, "Therefore, NRC will not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

229 1 control. physicians' prerogatives'on patient selection, 2 instrument selection, procedure selection, drug selection, 3 and dose level for most diagnostic uses of radioisotopes.

i 4 For all therapeutic uses of radioactive drugs, und in  ;

i

-5 certain diagnostic uses for example, the use of l 6- phosphorous-32 for localization of eye tumors and the risk 4

j 7 to patients is not low, therefore," so forth and so on, l

!- 8 "they'11 be more involved."-

9 So what they did in 1979, in addition to the l: 10 point that Dr. Lipoti makes, they did go on to 4

.11 characterize by what they -- what I would characterize as j 12' drawing the line, if you will. This is practice of e

13 medicine. This is fair game for regulatory concern by ,

14 this agency in view of its overall charge.

15 A couple of things have happened since the 16 1979 medical policy statement. I would argue that two 17 things have happened which have'gone both ways. One is-18 that in 1980 you had the misadministration reporting 19 requirement, which arguably I think some of you would view l

20 as an intrusion into the medical practice issue.

i 21 Now, there are reasons why the i 22 misadministration requirement was put in place, though the 23 original intent was to do things such as identify issues 24 which might generic in nature; and, therefore, we would 7 25 want to notify the rest of the regulated community.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000H701 (202) 234 4433

230 l

1 Thnn wa move forwnrd in tims to 1992 whcn wa l

2 put in place the quality management rule, which I think '

3 again I would expect that there would be an argument that 4 that was an aggressive move toward the practice of l

5 medicine, and certainly a deviation from the policy 1 l

6 statement as delineated in 1979. l l

7 Then, in 1985, the radiopharmacy rule comes l 8 into place, which recognized the practice of 9 radiopharmacy, removed all restrictions to follow the 10 package insert, removed restrictions in terms of route of 11- administration for therapeutic radiopharmaceuticals, and 12 so forth and so on. I think that the response would be 13 that was favorable to the practice of medicine. But it j 14 certainly is, once again, a departure from the line drawn 91I l

l 15 in 1979. I l

16 And so what I'm really saying is I think that l

17 while the medical policy statement is clearly etched as 18 written in 1979, there has been a dynamic going on all' 19 along, some favorable to the regulated community, if you 20 will, some not favorable to the regulated community, in 21 the context of the practice of medicine.

22 Is that a fair assessment?

23 CHAIRMAN STITT: Other comments? Dennis?

24 MEMBER SWANSON: I guess I still have a hard 25 time with the assessment of risk, and it comes with risk NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2N WASHINGTON D.C. 20005 3701 (202) 234 4433

i 231  !

)

1 relative to what. If we truly look at -- let's take  ! '

2 therapeutic uses of radioactive drugs - .you can say,

('~N 3 "Yes. The risk of patient radiation exposure is greater 4 than with the diagnostic use." That's one way of looking 5 at risk.

6' But what if we look at the risk of the 7 therapeutic use of iodine versus the risk of chemotherapy 8 or the risk of a surgical procedure? Then I would have to 9 say there isn't much difference in the relative risk.

10 So the risk from what standpoint are we 11 talking about here? And this is going to keep coming up

~

12 and up, because a question I have, a specific question, 13 for example, is nuclear pharmacy, which is my area, is s

\-- 14 that going to be treated as a high risk area? As a 15 manufacturer or distributor? Or is that going to be 16 treated as a low risk area? I could make an argument 17 either way.

18 CHAIRMAN STITT: Naomi?

19 DR. ALAZRAKI: The risk, though, the risk is 20 monitored carefully by the FDA in the area of pharmacy.

21 In the area of nuclear pharmacy, what are you concerned 22 about? The amount of activity at any one time?

23 MEMBER SWANSON: Well, I think right now if 24 you look at the way the NRC licensees nuclear pharmacies,

(N

'( ) 25 they license them in the same category as a manufacturer NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200060701 (202) 234 4433

232 1 and dictributoro. And if you lock ct, for extmplo, 2 option 3 here, they'll say, " Manufacturers and 3 distributors are examples of high risk." And all I'm 4 saying is I can make a strong argument that the nuclear  !

l 5 pharmacies are low risk because of the increased training )

6- and experience that people have coming into that area. l 7 Okay?

8 MR. CAMPER: Just a point of clarification. I 9 know where you're coming from on that, and what it -

and 10 what Dennia is picking up on was the discussion in one of 11 the strategic assessment papers -- maybe DSI 7 -- where 12 manufacturing is talked about as being a high risk 13 activity, that in turn what happens, he looks at the fact <

14 that radiopharmacies and manufacturers are both licensed 15 under Part 32. And then, in turn, that implies that it's 16 a high risk activity.

17 Well, the truth of the matter is is that 18 Part 32 says manufacturer or transfer of byproduct 19 materials. Radiophatracies are licensed under Part 32 20 under the "or traroimt of byproduct materials," a 21 component of Part 32, not the manufacturing component.

22 With regards to the risk involved, I can see 23 your point. I would argue that most activities in 24 radiopharmacy are low risk activities. Perhaps the only 25 high risk activities that I can immediately think of would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

233 1 b2 thoca involving lcrga qucntition of iodine.

m 2 CHAIRMAN STITT: Other comments? Lou?

l i 3 MEMBER WAGNER: In looking at this 1979 issue, 4 I guess what I would say is the following. I think the 5 Commission was certainly raising a very grave concern 6 about some incidents that had occurred that involved a 7 large number of patients. And I agree that that incident 8 has to go addressed. There is no doubt that the 9 regulatory process had to be reviewed on the basis of that 10 occurring.

11 What we don't have here, and what we -- what I 12 apparently don't have -- I haven't had the chance to read 13 this whole thing, so -- and I didn't do it.over the break.

b

(_,/ 14 But the whole history behind that is -- would be 15 interesting to know, because if you had thic many patients 16 who were overexposed, clearly there should have been an 17 investigation as to why that overexposure -- those 18 overexposures occurred.

19 And rather than having a knee-jerk reaction to 20 writing regulations in order to stop that potential thing, 21' perhaps because that occurred at such a level, an overall 22 view of why that occurred, what would have been the thing 23 to make right to have prevented such an occurrence, and 24 whether or not it would have practically been followed by O

( ) 25 that individual or that hospital or that institution NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200( 5 3701 (202) 234 4433

234 1 chould h va b2 n p rt of tha ravicw. And I renlly don't 2 know what did go on to set this whole thing in motion.

3 But what then went on was apparently a 4 relatively aggressive mode to start trying to control 5 radiation exposure to patients. And the NRC then started 6 running into conflicts with the medical community, which 7 is now a part of our history, and it's still with us today 8 20-some -- almost 20 years later.

9 MR. CAMPER: May I interrupt you for a minute, 10 Lou? I'm sorry. I apologize. But I have an 11 administrative issue which I apparently have to deal with.

12 MEMBER WAGNER: Oh, okay.

13 MR. CAMPER: This is a public meeting, but I 14 understand that there is an organization -- Mr.

15 Christopher Gray from the Gray Sheet FDC reports is 16 requesting that he be permitted to tape record the meeting 17 for the remainder of the day, and during the meeting 18 tomorrow. And I am told by those people in our agency who 19 deal with these things that if there is an objection to 20 that by any member of the committee that would disqualify 21 the capacity for such recording to be made.

22 MEMBER NELP: I object.

23 MR. CAMPER: Okay. We have an objection. Let 24 the record show that we have an objection, and we'll 25 pursue the matter administratively.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005 3701 (202) 234-4433

235 1 Thnnk you. Go ahead.

p 2 CHAIRMAN STITT: Jeff, you had some comments.

3 Let me just -- if we can just kind of pause 4 back to what Lou was saying. I think that is right on.

5 We have these three points from the medical policy 6- statement filed, as Bill pointed out, by the statement on I

7 page 8234. The Commission believes radio. use of drugs in 8 most cases is low risk.

, 9 Jeff, you're going to give us some more 10 information on the historical adventure, aren't you?

11 MEMBER WILLIAMSON: I actually wasn't. I was 12 -- well, sort of. I was -- if you consider it i 13 appropriate, I was going to mention some things related to

( ,h

\- / 14 risk associated with the so-called high risk therapy 15 procedures that might be worth thinking about too.

16 You know, some weeks ago, Barry Siegel ]

17 circulated by e-mail a very interesting set of abstracts 18 having to do with publications coming from Harvard Medical i

19 School and School of Public Health that basically l

20 indicated in general medical practice what the incidence l l21 of adverse events were, whether they're -- and what 22 fraction of them were caused by I guess I'll loosely call 23 it malpractice or some sort of mistake that could have ,

24 been I guess avoided. I don't know what the exact

/^)\

( 25 definitions were and which were not.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200(5 3701 (202) 234-4433

236 1 You know, it ecem:d liko tha ptrcantcga of 2 avoidable events had to -- was on the other of one to two 3 percent, something like that, about a third of the four 4 percent they said were events that could have been 5 avoided. Many of them had to do with actually physician 6- error, delivering -- physicians not having an adequate 7 knowledge of, for example, drug interaction or something 8 -- some such like that.

9 If we go back and look at what the history of 10 misadministrations are, there surely has been considerable 11 effort expended in trying to regulate our community over 12 'the last 10 to 15 years, all sorts of coercive measures 13 put in place to try and promote reporting of serious 14 treatment delivery errors.

15 And if you take that number of 16 misadministrations and divide it by the estimated number 17 of therapy procedures, it's an extremely tiny percent, 18 much orders of magnitude smaller than this one or two I

19 percent, something on the order of one out of between -- l 20 one out of 100,000 and one out of 10,000, if I recall.

21 Something on the order of one out of 20,000 it seems to me 22 was the final figure in the NAS report.

23 So I guess two points. One, the sort of very 24 narrow class of technical treatment deliveries that the 25 NRC is targeting by its current regulations is very small.

NEA.L R. GROSS COURT REPORTERS AND TRANSCRIBERS i 1323 RHODE ISLAND AVE., N.W. 1 (202) 234 4 433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433 l

237 1 It-in much emnllor, you know, then cort of avoidable error f-'s 2 rates in other medical subspecialties.

(

\'

3 And secondly, you know, the sort of issues I l 4 think that really impact the quality of patient care are 5 those that clearly fall outside of NRC's bailiwick anyway.

6- It's, do you draw the blocks adequately for a Hodgkin's 7 Disease patient? Are you irradiating the correct volume 8 of tissue to be sure that you eradicate all known 9 microscopic disease?

10 And, you know, this is a sort of issue of 4

i 11 competence of individual practitioners. One reason -- so 12 this is not something you can regulate anyway, and that 13 probably, you know, perhaps in some sense pushes up the

[b

\_ / 14 incidence of avoidable errors. I think one reason it's so 15 -- there's so much contention between the regulated 1 <6 community and the NRC is you just don't seem to get where

, 17 this small category of very low probability events fits in 18 within the big picture. There is not an appreciation of 19 balance, and you can sometimes go to great lengths, such 20 lengths that you sort of totally distort the practice of 21 quality assurance pattern within an institution.

22 MR. CAMPER: Let me address that, because I --

23 this is really fascinating, because I have not read this 24 sentence for a long time. But getting back to Dr.

s I, 25 Wagner's point -- again, let me draw your attention to the N

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 5 3701 (202) 234 4433

238 1 FRN, 8243 of th3 FRN. And I think wh t you'll find is 2 some of the bases, and i",'s certainly not risk in the 3 classical sense, Lou. But if you pick up on the bottom of 4 the first column -- and I'll read aloud. Bear with me.

5 MEMBER NELP: Which page?

6- MR. CAMPER: 8243. What you'll find, the next 7 two columns, is a rationale. It says, "The second part of 8 NRC's policy statement indicates that NRC will regulate 9 the radiation safety of patients where justified by risk 10 to patients and where voluntary standards or compliance 11 with these standards are inadequate. As noted before, NRC 12 has the authority to regulate the radiation safety of 13 patients.

14 "The NAS-BEIR report discusses limiting the 15 exposure of the population to medical applications of 16 ionizing radiation. That report, which includes all 17 medical uses of ionizing radiation, shows an average dose 18 rate from radiopharmaceuticals of one millirem per year, l l

19 and an average dose rate from diagnostic radiology of 72 20 millirem per year in 1970." l 21 The following quotation is from the NAS-BEIR 1

22 report. "In the foreseeable future, the major 23 contributors to radiation exposure of the population will 24 continue to be natural background with an average of whole 25 body dose of about 100 millirem per year, and medical h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 2000 # 3701 (202) 234-4433

239 1

applications which now contribute comparable exposures to s 2 various tissues of the body.

3 " Medical exposures are not under the control 4 or guidance by regulation or law at present. The use of  :

5 ionizing radiation in medicine is of tremendous value, but  !

6 it is essential to reduce exposure since this can be  !

7 accomplished without loss of benefit and at a relatively 8 low cost. l 9 "The aim is not only to reduce the radiation 10 exposures to the individuals, but also to have procedures '

11 carried out with maximum efficiency so that there can be a .

12 continuing increase in medical benefits accomplished,"  ;

13 blah, blah, blah.

14 Then it really goes on to say that "NRC will 15 act to help ensure that radiation exposure to patients is  :

i 16 as low as reasonably achievable, consistent with competent 17 medical care and with minimum intrusion into medical ,

18 judgment. The NRC will not exercise regulatory control in )

19 those areas where upon careful examination it determines 20 that there is inadequate regulations by other federal or 21 state agencies," and so forth and so on.

22 Then it -- what is very interesting also is 23 the third part of NRC's policy statement. It indicates 24 that the NRC will minimize intrusion." And then, I 25 basically, if you read on, what it goes on to say is that NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON D.C. 2000H701 (202) 234 4 433 1

240 1

tha NRC rccognizes that medical judgment is the province 2 of medical practitioners. However, medical practitioners 3 make mistakes. And because medical practitioners make 4 mistakes, the NRC will continue to be involved to some 5 degree.

6 And what I'm saying is is while you -- I would 7 certainly agree that this is not a classical risk 8 approach. It is the rationale for the position taken in 9 the 1979 policy statement. Now, you can debate whether 10 the rationale is appropriate, or was appropriate. You can 11 debate whether it's appropriate today. But on the 12 question of intrusion, at least as I read this, it seems 13 to be the bottom line was is that practitioners, while you 14 have the responsibility, will make mistakes.

15 CHAIRMAN STITT: John had my attention, and 16 then Lou.

17 John, go ahead.

18 MEMBER GRAHAM: One of the goals that you had i

19 stated earlier this afternoon was to at least comment on l

20 direction-setting issue paper number 12. And I think the 21 reference to the medical policy statement in 1979 came up 22 during the initial overview by Larry on that paper. And 23 if you look at page 10 of that summary, it states that the l 1

24 Commission's preliminary views were that higher risk l

25 activities should be primary focus of efforts and NEAL R. GROSS COURT REPORTERS AND1RANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON. D.C. 20005-3701 (202) 2344 433

241 1 resources. It gono on to soma other bulleto.

2 I'd propose that the ACMU would recommend that l

s) 3 the NRC revise its medical policy statement, leaving 4 statement number-1 intact, modifying statement number 2 1

5 with the sole insertion of the word "high" before " risk," -

6 so that it would read that "the NRC will regulate the 7 radiation safety of patients where justified by the high 8 risk to patients, and where voluntary standards or '

9 compliance with these standards are inadequate." Leave 10 number 3 intact. And a major charge to this committee

• 11 would be discussing how to distinguish high risk from all 12 other.

13 CHAIRMAN STITT: Is that a comment or a 14 motion? How risky do you feel today?

15 MEMBER GRAHAM: So moved. '

16 CHAIRMAN STITT: That will energize the 17 committee to --

l 18 MEMBER NELP: That's a high risk comment.

19 CHAIRMAN STITT: -- to make --

20 MEMBER NELP: A high risk motion.

21 CHAIRMAN STITT: Let's discuss this. Well, do 22 we need a second to the -- anybody want to second that? l 23 MEMBER FLYNN: Let me make a comment. High 24 risk to patients or high risk to groups of patients, 25 because if it's the Riverside Hospital incident, my

(

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 200054701 (202) 2344433

242 i

1 undarctonding of that was thet it was a problem with 2 calibration maybe in a wedge factor, whatever it was, ,

3 calibration error which resulted in many patients being 4 overexposed. It wasn't individual patients, but it was a 5 calibration error.

6 For example, like with strontium ophthalmic 7 applicators, if you have a strontium ophthalmic applicator 8 which is miscalibrated and you're giving, let's say, three 9 times the dose to 400 patients, that's more serious than 10 an individual patient where there was an unavoidable human 11 error that occurs one in 20,000 or one in 50,000. So I 12 think the focus should be on issues which cause systematic 13 errors exposing large numbers of patients to high risk, as 14 opposed to -- I don't think you can eliminate risk, and I 15 think that's what all of these comments were getting to.

16 You may give a cardiac drug that somehow the 17 dosage was wrong because someone made a miscalculation, as 18 opposed to if, let's say, all of the cardiac meds, in the 19 hospital were 10 times the potency and no one was checking 1

20 on it, and all of these hundreds and hundreds of patients 1

were getting the wrong dosage by a factor of 10 and they 21 22 were developing arrhythmias, or whatever. That's a much 1

23 more serious problem than an individual mishap. j 24 So I don't know if you want to put high risk 25 to -- I don't know how to say it. Il l

NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBEPJ 1323 RHODE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200054701 (202) 234-4433 l

243 1 CHAIRMAN STITT: Rick ccn be looked at in both ew s 2 of those ways. I mean, when -- JCHO actually wants you to 3 be doing assessment of procedures or patient groups where 4 there may be very few in number, but that carries some 5 risk, as well as something that you do repeatedly. But 6 because you do something when there's such a volume that 7 that actually --

8 MEMBER FLYNN: But I never objected to the NRC 9 being involved in making sure that sources are calibrated 10 correctly. That's not an intrusion into medical judgment.

11 And by making sure they are calibrated correctly, they are 12 protecting hundreds and hundreds of patients from serious 13 injury. And that doesn't get involved with the doctor-O)

(s, 14 patient relationship in that regard, and that's what the 15 Riverside accident was. It was a calibration problem, not 16 a doctor-patient problem.

17 MR. CAMPER: Yes. It was an incorrect 18 plotting, and the bean was not evaluated with the chamber 19 for two years. Correct.

1 20 CHAIRMAN STITT: John?

i 21 MEMBER GRAHAM: But to the extent that this 1 22 committee recommended that that constituted high risk, l 23 that would remain appropriate regulatory activity. I'm 24 simply stating that the way it read in '79 was as

()

rN 25 justified by the risk to the patients. And I have sat NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

244 1 through dozcne of hours of diccuncion now about what is 2 high risk, what is low risk. All I'm suggesting is at 3 least we recommend that they raise the bar to be high '

4 risk, and then we still have to work with them to define l l

5 what high risk is.

6 DR. ALAZRAKI: I would like to just second the 7 motion. I don't think anybody seconded it.

8 CHAIRMAN STITT: All right. So now we can l

9 officially keep discussing this. Well, I mean, this has l

10 some interesting -- I mean, just the way you've set this 11 up, John, and sort of deliberately using materials that I 1

12 are a part of the Federal Recister and pulling something 13 from '79 back into today's lingo, and also, as you've  ;

14 pointed out, Jill, the way it reads. They're talking l 15 about risk at that time. So let's keep discussing it.

16 Naomi?

17 DR. ALAZRAKI: I think the intent of the 18 motion is to at least separate out at this point, and then 19 we can argue what to do to refine the high risk clause, 20 but to separate out clearly I think the diagnostic 21 patients, since there is no high risk. I mean, the risk 22 is very low for possible harm to any individual patient.

23 And I think that's what this accomplishes. So from that 24 point of view, I think it's worth passing.

25 CHAIRMAN STITT: I want to have more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 2344433

~ _ . _ - -

I 245 1 discussion on what -- let'a really focus on diagnostic and l

<~'  !

2 more detail about what that really means, some specific l Cs) 3 examples, some isotopes, patient cases, etcetera. )

j 4 Lou, go ahead.

5 MEMBER WAGNER: Well, I think what the NRC is 6 trying to get at is the fact that, as they state in their l

7 paper, the guidance was at that time that radiation doses 8 provided to patients was higher than it had to be in many 9 cases, and they felt it could be' brought down, and the 10 regulatory motions were the arm to use in order to bring 11 down radiation exposures to patients from these materials.

12 And I would say that while the intention is

,_ 13 correct, the mechanism is wrong. And that's where I would

/ \

(_ / 14 object to the way things have evolved over time. And I 15 think it's retrospective sight. It's not necessarily that 16 the people at the time did something stupid or dumb or 17 wrong, and that's not a criticism of them. My God, it was 18 too long ago.

19 But the point is it has brought us to the 20 points where we are today, where now the technology is 21 entirely different. The things we are doing are entirely 22 different, and we have a totally different situation. We 23 have to look at the situation in the present-day world and 24 say, "What regulations are rea.lly so offensive, and why l

y j 25 did they get that way?" I'll show you ideas and concepts NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 2344 433

246 1 of things thnt I think cre offcnciva to m3.

1 2 I don't like ALARA as a regulation. I think ,

1 1

3 ALARA as a regulation is demeaning to ALARA. ALARA is a i 4 very fine concept. It's a great idea, because we really I

5 don't --

won't know whether or not these low doses of  !

6' radiation cause any harm or not. All of the data that is ,

1 7 in on that is conflicting and much of it is negative. The 1

8 idea that -- the obvious fact is is that if there are l 9 risks associated with it they are so small they're getting j 10 buried amongst the noise of other risks that exist in the l 11 population.

12 So why are we regulating at that level? It I

13 doesn't seem to me to make it a regulation makes any l 14 sense. Now, we should promote it as a principle. It's a 15 great principle. It's a great philosophy to expound. But 16 to make it a regulation, I don't see the need.

17 Wipe tests that are done on these packages 18 that come in every day -- wipe tests and surveys of 19 packages where we're only ordering technetium or we're 20 ordering some other diagnostic modality. I have never 21 seen a package leak on the shipments that I've gone in, 22 because the regulations on the people who ship them are 23 very high. The packages come in. We have never had one 24 that ever leaked,in all the years I've been around.

25 And even if they did leak, I can't see that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 -

247 1 they would poas cny scrious hazard to cnybody, because of g-- 2 the technetium and stuff that's in it. The only way it k

N- '/ 3 could be a hazard is if somebody took it out and perhaps 4 consumed a large portion of it, or if it got lost or 5 something and somebody misused it. Maybe those are risks 6 and issues.

7 But the contamination levels, we have to test 8 that, and the things we have to do all of the time, and 9 then we're cited if only on a few times out of 500 that we 10 did during the year, a few times there wasn't a record of 11 what we did, and then we're cited for it and we're not 12 praised for having done it 99.98 percent of the time, or

,_ 13 whatever. This is all out of proportion. It's all out of f \

V 14 proportion.

15 I think those are the issues that really well 16 up the contentious atmosphere that we currently have And 17 I think this is where we have to start addressing issues 18 and to now discuss I think in detail this diagnostic 19 issue. I'm not sure -- the problem is a procedural one.

20 How can we discuss it within a framework whereby we will 21 be productive in terms of our recommendations? Because we 22 haven't -- we have really got to focus -- a) what is 23 contentious? What is wrong about the regulation as it 24 currently stands? And what really needs to be modified O)

( 25 about it? And we're not really prepared, as I see, to NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISU.ND AVE., N.W.

(202) 234 4433 VMSHINGTON, D.C. 20006 3701 (202) 234 4433

248 1 roelly cddroca that vary cpscific incuo because, a) we 2 just got this paper a few hours ago. 1 3 CHAIRMAN STITT: Wil? l l

4 MEMBER NELP: I have a question and then a l 5 comment. My question I guess is to Larry, who is -- after 6- the '79 incident, what -- we've talked about it some.

7 What were the effective changes in the regulations at that 8 time? Do you recall specifically?

i 9 MR. CAMPER: Yes, I went through them earlier.

I 10 MEMBER NELP: I know it's been stated. l 11 MR. CAMPER: Right. I went through them 12 earlier. But I'll -- what they were --

l 13 MEMBER NELP: Very, very briefly.

1 14 MR. CAMPER: Yes. There were two significant  !

l 15 changes that occurred. The events occurred with Riverside 16 I think it was '76/' 77 timeframe. In 1979, we put in 17 place the quality assurance, calibration checks, safety 18 instructions, interlock requirements, etcetera, etcetera, 19 that you'll now find in 35-600 under "telether&py."

20 Subsequently, in either August or November of 1980, the 21 misadministration reporting requirement came in to be.

22 And both of those regulatory promulgations came about as a 23 result of, not totally, but certainly in large part 24 because of the Riverside incident.

25 MEMBER NELP: I'd like to comment now on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

249 1 motion. It mny b2 e little prematura, but I think we're p-s 2 in the process of defining what the heck high risk really

\/ 3 is, and that's the essence -- we'll have to do that if we 4 pass the motion, and we have to'say, "Okay. Now, what did 5 we really pass?"

6 And it seems to me that, in 1992, high risk l

7 and quality management came into line, as I read what has 1

8 happened to the regulations. And prior to that .-- and so l l

9 the quality management program, that particular thing, i l

10 which I think is somewhat burdensome, was put into  ;

11 therapeutic uses of radiation materials, sealed sources, ,

i 12 and in nuclear medicine.

13 I asked this question before, but does high

(, ,) 14 risk really imply that the QM is sort of -- it's implicit 15 that QM and high risk go together in the regulations.

16 That's the way they're built now. And I'm even wondering 17 if you can define if you really want QM, even if you do 18 define high risk. So I think we have the opportunity to 19 look at that, too.

20 MR. CAMPER: Right. With regards to QM, a 21 couple of observations.

22 MEMBER NELP: I will say in my own practice of 23 therapy, and I would bet it's the same for Naomi's, which 24 is largely I-131 therapy, not entirely, the QM that you r

25 put into regulation is being followed. I mean, it wasn't (hv)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

250 1 any difforent then what wa alrandy do. And if we didn't 2 already do it, we would consider ourselves negligent.

3 CHAIRMAN STITT: John, you were pointing to --

4 MEMBER GRAHAM: Just to clarify, Dr. Nelp, 5 that in debating the form that a motion should take, there 6- is a concern that we are trying to recommend a policy 7 statement that would not go far enough to protect the 8 public good. It's a concern I had. But I was extremely 9 comfortable when you get done reading statement number 1 10 that if we leave intact "The NRC will continue to regulate 11 the medical uses of radioisotopes as necessary to provide 12 for the radiation safety of workers and the general 13 public," that we have left a huge avenue available for i

14 appropriate regulation, and this group will have to 15 continue to debate with staff where to draw the line on 16 that.

17 But is leaving intact a clear statement that 18 radiation safety of workers and the general public is the 19 legitimate and normal purview of this group? I think Lou 20 will continue to have to debate whether a given procedure 21 is a legitimate protection of that safety, but at least 22 we're beginning to zero in on the fact that there are 23 portions of diagnostic work with patients that 17 years 24 later we just don't need the level of regulation. It's a 25 long journey. I'm just trying to move us one rung up that h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

251 1 laddar.

2 CHAIRMAN STITT: Could I ask --

3 MEMBER GRAHAM: And I'm mixing metaphors, so j 4 I'll quit, a

5 MEMBER NELP: Well, you could modify it to say 6 "by extremely high risk to patients."

7 CHAIRMAN STITT: That I think is too 8 qualitative.

9 Could I ask the diagnostic folks here -- now, 10 maybe I'm presuming. I'll just speak out of my own 11 ignorance and assume that Commissioners and the staff

12 would like some further clarification. But the diagnostic 13 folks here, we have been talking about these notes or V 14 these -- the Federal Recister written in '79. A lot of 15 changes have taken place, as everybody said. Could we 16 have some specific examples in the diagnostic community, 17 different sources, different vehicles? Tell us some of 18 those changes so that we can have them out on the table 19 and into the minutes.

l 20 MEMBER NELP: Changes of -- I'11 be happy to 21 answer that if you'll --

22 CHAIRMAN STITT: Everybody can take a chance.

23 Let's go around the diagnostic group here.

24 Go ahead, Wil.

m 25 MEMBER NELP: Well, 85 percent of the work NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

252 1 thnt wa do in mndiccl diagnosio or nuclcer m; dical 2 diagnosis uses technetium-99M as the label. So that {

3 immediately identifies very, very low risk in general 4 terms.

5 I can't think of any other diagnostic 6 procedure that we do where the radiation portion of the 7 procedure has any inherent risk that anyone would consider 8 anything but low. I can believe there are exceptions to 9 that.

10 We do some administration of I-131 labeled i

11 compounds, and they are always at the diagnostic level.

12 For example, some of the adrenal imaging agents, we always 13 administer cold iodine to protect the thyroid, which it 14 really isn't necessary anyway, but it is always done as a G, 15 matter of procedure, and I think probably without fail.

16 So I don't think there is any question that 17 the diagnostic use of radioactive materials to the 18 individual patient is extremely low risk.

19 MR. CAMPER: Can I ask you to help me out with 20 that?

21 MEMBER NELP: Yes.

22 MR. CAMPER: That was true in 1979 also.

23 MEMBER NELP: It's more true now than it was 24 in '79.

25 MR. CAMPER: But the exposure parameters NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 2344433

253 1 accociated with technatium, and the parcentego that 2 technetium constituted, was the same in 1979. And what

\-./ 3 I'm saying is, I'm trying to find a way to help the 4 Commission move from its previous position. So bear with 5 me.

6 If that is true, and it was true in 1979, and 7 the 100 millirem criteria that was addressed by BEIR,

! 8 since that time the regulation -- you know, ICRP has 9 recommended a target dose for the population of 100 10 millirem; 100 millirem to members of the public is now i

11 embodied within the regulations. How can I then, in turn, 12 use the argument that technetium is inconsequential?

13 I'm just trying to move away from the p

\ 14 previous --

15 MEMBER NELP: I had a question on the. comment 4

16 and then I will answer it. Could you explain how 100 17 millirem is embodied in the regulation, and you're 18 referring to ALARA --

19 MR. CAMPER: I'm saying that the -- no, no, j

20 no. Part 20 now has an explicit exposure limitation of i 21 100 millirem to members of the public.

22 MEMBER NELP: In what regulation?

23 MR. CAMPER: Licensees are to conduct their i

24 activities to protect members of the public at a level of f

i 25 100 millirem.

(u.)J)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

254 1 DR. ALAZRAKI: Yes. But that's for the 2 general --

3 MEMBER NELP: But that's for the whole --

4 DR. ALAZRAKI: That's for the whole 5 population.

6 MR. CAMPER: I understand that. I understand 7 that.

8 MEMBER NELP: And that's saying that no 9 individual --

10 MR. CAMPER: I understand that. What I'm 11 saying is --

12 MEMBER NELP: But we're actually modifying 13 that, aren't we, to 500 mr to --

14 MR. CAMPER: Well, no, what you're -- well, 15 for purposes of the patient release, that's correct. All 16 I'm saying is, if you make the argument that it's about 17 technetium, and 85 percent of what we do is technetium, 18 and the exposures are low, all I'm saying to you is that 19 when this position was put forth in 1979, that was true 20 then, it's true now.

21 The 100 millirem that was cited in this l document as a guidance has now been incorporated, l

22 l

23 protection of the public, at 100 millirem. All I'm saying 24 is the argument that it's inconsequential -- I recognize 25 the patient issue is different -- is saying that help me NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

l l

255 l 1 ce to why that is a position to move away from the

(~'N 2 previous position. j

\ l 3 MEMBER NELP: The volume of diagnostic 1

4 procedures and the individual diagnostic procedures, as 5 though people migrate from all of these laboratories into 6 the public domain, their exposure rates are very low.

7 Now, that's all -- I don't have those numbers, but we do 8 those procedures. There are no restrictions in our 9 hospitals that you go back to the ward after diagnostic 10 procedures or out on the street, and that's because they l 11 are low. Now, I don't know if this is clearly documented.

12 The other thing is, Larry, just because

- 13 somebody said something was true --

. 14 MR. CAMPER: Right.

15 MEMBER NELP: -- in 1979, regarding the BEIR 16 report, there is absolutely no evidence -- period -- there 17 isn't conflicting evidence, there is no evidence, 100 mr, l 18 500 mr per year has any adverse health effect on any 19 population that has ever been studied, and I think you l 20 have to reiterate that, or this committee should. l 21 MR. CAMPER: I recognize that. I recognize 22 that.

23 MEMBER NELP: So, you know, you're putting an 24 assumption which isn't worthy of support in front of an

!o) s 25 argument which is clearly -- well, you're using one to NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

1 j 256  ;

l 1 cdvercoly affect tha othar wh;n tha 100 mr par year is --

l l

2 MR. CAMPER: No, I understand. I'm just --

3 I'm only bringing up what the basis was then, that's  !

4 discussed in this document. And what is -- you said it's l

, 5 different now than it was then. I'm saying, what's 1 l 1 6' different?

l 7 MEMBER NELP: Well, there --

8 MR. CAMPER: Why is it different?

i 9 CHAIRMAN STITT: Lou, speak. I 10 MEMBER WAGNER: There's several things that I 11 are different. There are many things that are different.

. I 12 CHAIRMAN STITT: Write this down.

l 13 MEMBER WAGNER: First of all, let's look at 14 this 100 millirem per year. This is not based upon any l 15 known risk. This is not based upon any known risk. It is 16 an extrapolation from higher doses that did produce 17 effects. That's the first thing.

18 The second thing is if you look at the new 19 BEIR report, and I believe the number was like around 15 20 rem, they didn't really express any risks except for doses 21 in excess, and I think it was 15 rem -- that's my 22 recollection -- but it was a much higher dose level. They 23 come to the conclusion about this 100 millirem, the NCRP l

24 does, based upon estimates of what might occur and giving 25 a very conservative, safe level for the public. h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

l (202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

257 1

This is tha whole idsa and rctionale for 100 2 millirem per year. So, number 1, that doesn't apply at 7--)

\,

's 3 all to medicine. Number 2, if you go to medicine and you 4 look at the amount of doses that have been delivered from 5 many different exams, there has been lots of studies. And 6 the only studies that have ever shown any correlation 7 between the medical application of radiation and some 8 effect is all done at high doses.

9 And I can show you the studies involving, for 10 example, iodine-131. There has been at least two studies 11 done on iodine-131, where over 20,000 patients were 12 involved in both studies. One of them looked at patients 13 with Graves Disease, and the other one looked at patients 14 who had been diagnosed with normal thyroids and were 15 followed up later. Neither of them showed any correlation 16 with increased cancer incidence, either thyroid cancer or 17 other cancers, except for perhaps leukemia, wherein the 18 leukemia was associated with the Graves Disease and not 19 with the radiation.

l 20 And so there is lots of studies now that are 21 -- at least those are very important studies that we now 22 have available to us, which indicate that there isn't --

23 we can't find any reasonable risk associated with these 24 diagnostic doses. And the other factor is is that the

\

f'A 25 doses that were delivered to the thyroid from those iodine

\

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE N.W. l (202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433 j

258 1 otudics wce on tha cvarcga cbout 50 rad. It was a very 2 high dose.

3 These aren't anything like the doses that 4 we're delivering today. We've taken over much of the 5 iodine-131 with iodine-123. The technology for imaging 6- has gotten a lot better, and that may or may not reduce 7 the dose. That can, at times, increase the dose because 8 the technology requires better statistics at what we do 9 perhaps. But those are all medical decisions to be made 10 on the basis of what is best for the patient.

11 And when you look at these kinde of 12 experiences, to me that's a huge change in what has gone 13 on. I mean, we've changed isotopes, we've changed all 14 kinds of things, and we've gotten a lot better data that 15 is available now. So it wasn't available then.

16 MR. CAMPER: What I hear when you say that is 17 a couple of things. I hear what you're saying is that the 18 basis that the 1979 medical policy statement is drawn on, 19 the idea that the 100 millirem per year is a number that 20 should be of concern, and, in turn, we should keep the 21 exposures as low as reasonably achievable, is a flawed 22 basis.

23 And the second thing I hear is that current 24 scientific literature should be reviewed and serve as a 25 basis for establishing risk, and move away from this NEAL R. GROSS COURT REPOR17.RS AND TRANSCRIBERS

, 1323 RHODE ISL.AND AVE., N.W.

( ,

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

259 1 concept that it'a 100 millirem, and even lower is better.

g'~s 2 MEMBER WAGNER: Yes. That's a philosophy, and

' 's 3 that's why I've always said that -- ALARA always was a 4 philosophy,'and that's why I really cringed when I saw it 5 as a regulation. I said, "This is a philosophy. It's 6 based upon philosophy and no known risk."- And it's my 7 belief, and firmly, that it should never have become a 8 regulation. But it should have stayed a'very good I 9 operational philosophy, which is what it is. It's a very 10 good -- and that's what it was proposed as originally, as l

11 a very good operational philosophy, which became a l 1

12 regulation later. I rs 13 You know, I'm not proposing that we make s- 14 things worse for people. What I am proposing is that you 15 can look at a lot of the regulation, which we have to go 16 through and which we are held accountable for, which is 17 not producing any meaningful benefit, and that's the stuff 1

18 that has to be dumped out. It has to be done away with.

I 19 And what we have to focus on is what 20 regulations do provide meaningful benefit, both to the 21 population and perhaps in some instances to the patient  ;

22 population. Because I agree that there are times when

, 23 physicians will get carried away and give doses that are l

24 unusual. There are doctors out there that are operating l

25 -- or can operate in that way, and I don't want to see NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 2344 433

1 260 1 th:m oparato that way. '

2 One of the things that we can hedge against 3 that is perhaps have a better review of the qualifications 4 of individuals who are going to be authorized users in the 5 field, and we have to review that very carefully. But 6 overall, the whole point is that there's a lot of 7 radiation -- a lot of regulation out there which is 8 written into law. And if you violate it, boy, they're 9 going to come down on you. And it just doesn't have to be 10 there. It isn't causing any meaningful benefit.

11 CHAIRMAN STITT: The calls are lining up here.

12 Let's go with Dennis, and then we'll work down this side 13 of the tree. Dennis?

14 MEMBER SWANSON: Just one quick comment. You 15 must remember that when you talk about risk of radiation 16 to patients you are also talking about exposing them to 17 those risks with the idea of getting a benefit from it, 18 which may not apply when you talk about risk of radiation 19 exposure to the public.

20 And secondly, I think actually where the NRC I 21 has perhaps created the most difficulties in the second 22 part of this statement, where it says, "The NRC will 23 regulate radiation safety of patients where justified by l 24 the risk, and -- and -- where voluntary standards or 25 compliance with these standards are inadequate."

NEld. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

261 1 And fundamsntally, if you look at the quality

[)

V 2 management rule, which is I think the one that really 3 started a lot of this turmoil, much to the complaint of  !

4 'the community, was th3t the NRC is holding radiation users l 5 to a different standard than traditional medical practice, 6' and the quality management rule is a good example.

l 7 We just passed a regulation where we have to j l

8 provide written information. It specifies written l 9 information to patients. We have expressed our concerns 10 about that. But it seems like the NRC again, doesn't know ,

i 11 what is the standard of medical care. It comes back to 12 that. Now they are holding us to a different set of 13 standards. It's this part of the statement where they i

\m l 14 have really gone wrong, in my opinion.

15 CHAIRMAN STITT: Talk to me more about that.

16 What do you mean? You mean it shouldn't be there at all 17 or --

18 MEMBER SWANSON: No. I think it's actually 19 where the NRC has gone beyond its boundaries of its 20 medical statement. It says here, this is their medical 21 policy statement, the NRC will regulate the radiation 22 safety where justified by the rest of the patients and, 23 remember it's and not or, and where voluntary standards in 24 compliance with these standards are inadequate.

(

() 25 CHAIRMAN STITT: Well, it also asks in whose NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

262 i

1 opinion are thny inrdaqunto.

2 MEMBER SWANSON: Exactly. 1 3 MR. CAMPER: Well, that's right. That's a 4 good point because if you go back and look at the history 5 of the QM rule, what you find is what the commission was l l

6' concerned about was that you were running in those days t

7 around 400 diagnostic misadministrations per year. There 8 was nothing in the industry that was comparable that 1

9 required reporting of these esents. You can argue that it l

10 wasn't necessary, I recognize that.

i 11 You were running 25 or 30 misadministrations 12 per year. Essentially the Commission looked at this and 13 said the number can and shculd be lower.

14 As a result of that, the quality management '

15 rule ultimately came to be. Now it is characterized as 16 providing high confidence that materials will be l

17 administered as directed, da da da da da, because you are j 1

18 obviously you are trying to reach zeros. It's absolute i

19 and probably not achievable.

20 But the Commission, I would argue, looked at 21 what was going on and said there not an adequate program 22 in place. There are not voluntary standards that are i 23 capturing this problem. It did not want to remain in the 24 lull of seeing 30 therapeutic misadministrations per year, 25 400 diagnostic misadministrations per year, not take some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4 433

263 1 strong action to do comething to further reduce the g-^g 2 number. I am just explaining the rationale. I'm not --

(

'-) . 3 CHAIRMAN STITT: And I would like to add that 4 over time, both in therapy as well as diagnostic, I mean 5 there are national groups that now spend hours developing 6' standards. They are very broad based with input from all 7 quadrants. So that certainly is something that's quite 8 different, maybe rather recent, certainly parts of it are.

9 The American College of Radiology just 10 finished approving standards for high dose rate 11 brachytherapy. That's just one of many standards that are 12 available.

13 So possibly or is a substitution that we could

('_ \

\s / 14 consider. Or -- that's not a motion, I'm just making 15 comments.

16 I think this side of the table has their --

17 we're going to auction these things off to see, and use 18 the money for donuts. Go ahead, John.

19 MEMBER GRAHAM: Well, mine was just a 20 clarification of the last comment, that by modifying 21 number two, could state that we're justified by the high 22 risk to patients, and leaving it and where voluntary 23 standards or compliance with these standards are 24 inadequate, you have elevated the entire bar.

O

() 25 So were there clearly voluntary standards in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D C. 2000 5 3701 (202) 234 4433

264 1 complianca with thsco etandarda and thera's a low risk to 2 the patient, that would fall out of normal regulatory 3 review. I think the onus, if I was a commissioner, I 4 would direct this group to begin assisting in the 5 documentation of recent BEIR studies and other medical 6 literature that clearly bowed that there are elements of 7 what are taking place. I.n hearing almost all of the 8 diagnostic use, that would not fit a definition of high l

9 risk.

10 CHAIRMAN STITT: Naomi, were you gesturing l l

11 earlier co make some comments?

12 DR. ALAZRAKI: Well, I think most of the I 13 comments have been made. I could just add a few maybe, I 14 don't know, refinements. That is, that the argument about i 15 the 100 millirem, I mean as we all know, radiation is a 16 fact of life. It's all around us. Just from living on 17 earth, at sea level we're probably getting 250 or 300 MR 18 per year. So you're talking about an additional 100 MR, I 19 mean, and if you live in Denver, you are getting some 20 factor much more than that. If you live in Nepal, you are 21 getting about 1,500 MR per year just from living on earth.

22 There's no evidence that the people living at 23 1,500 MR per year have any higher incidence of any kind of 24 cancers or any other genetic problems than the people 25 living at sea level.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

265 1 So all of these arguments for low dose g'~N 2 administrations of these radionuclides, just don't make

\

) 3 really any sense. There isn't always, as Lou said, 4 demonstrated increased risk to any individual from the 5 amount of radiation that one gets from a diagnostic

, 6 nuclear medicine procedure or a diagnostic radiologic i

7 procedure, for that matter. So clearly these are low

8 risk.

9 The refinements that we've seen in the 10 cliniccl arena over the years have to do I think primarily 4

! 11 with the imaging instrumentation and the fact that we do 12 so much better and can do with less. That's particularly

,-s, 13 true I think in the pediatric population, where we can ss 14 really get the doses down where perhaps it's a little bit i

15 more important to do that.

16 But even in the pediatric population, we're

]

i 17 talking about doses so low that we really don't have to I

18 l consider it other than low risk.  !

i  !

19 And the refinements perhaps in tools, small  !

20 pieces of supply or equipment type things for handling the 21 radioactive materials which have improved over the years 4

22 as well, and reducing the exposures to personnel.

23 CHAIRMAN STITT: Dan and Jill and Lou.  ;

1 24 MEMBER FLYNN: Oh. I think NCRP, since 1979, f

4 k)) 25 NCRP now estimates that the average U.S. citizen's annual NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

266 1 exposure is 360 millircm per year baccuco of including 2 radar, whether you want to do that or not. I think in 3 Denver you are getting about 25 or 30 millirem a year more 4 being in Denver at 5,000 feet.

5 But in terms of the thyroid studies, a lot of 6" the thyroid studies using therapeutic levels of isotopes 7 have been published in 1991, 1992, and 1993. One of the 8 key authors in that, if you want to look it up, is John 9 Boice, B-O-I-C-E. They have actually combined large 10 population studies, epidemiological studies following 11 patients for 20 years, including the newest update on the 12 atomic bomb survivors.

13 That is, in terms of thyroid, for example, 14 they did not see increased thyroid cancer in Japanese 15 males who were exposed at the time. That data has now 16 broken out that there's no -- only in children under 15, 17 which corresponds to the new data coming out in Chernobyl 18 for children exposed to high levels.

19 But I don't think, and those were at least at 20 therapeutic doses. And including another study where 21 thyroid cancer patients given therapeutic levels of iodine 22 131, they looked to see if these thyroid cancer patients 23 who survived and lived, whether they would get secondary 24 cancers, or do they have a higher risk for a thyroid 25 cancer itself. The answer was no.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

267 1 But my quantion would be for children ct s 2 diagnostic levels. Is there any information with iodine

'k- 3 for diagnostic tests. And how often do you do diagnostic 4 tests on someone under age 15?

5 MEMBER NELP: Very very very rare. Most of 6 those children are --

7 MEMBER FLYNN: Because this data on iodine is 8 relatively new. These are large populations of people.

9 These are studies sponsored by NIH and a number of, U.S.

10 Health Service. This is new information, radiation 11 research. Radiation research is one area that's 12 published.

13 CHAIRMAN STITT: Jill, go ahead.

O

(, 14 MS. LIPOTI: I have a lot of comments. I have 15 been saving them up. So you have to be patient now.

16 CHAIRMAN STITT: You have got the floor. It's 17 all yours.

18 MS. LIPOTI: First of all, you have to realize 19 that all regulation is not aimed at the folks who comply 20 with regulations. It is aimed at the bad actors. So the 21 people at this table are going to say well this regulation 22 is not necessary, I do all that anyway. Because you are a 23 responsible person.

24 But there still are individuals who use v ) 25 radioactive materials in medicine who are not responsible NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOCE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006 3701 (202) 234 4 33

268 1 individuelo. That'c the folks that wa have to ecptura 2 when a regulation is written. Because that's where the 1 3 mistakes are being made.

4 When you talk about a voluntary program, l

5 essentially ACR had a wonderful voluntary program for 1 1

6- mammography. It was terrific. The facilities that 7 complied with all of the ACR requirements found it 8 extremely easy to come into compliance with the MQSA.

9 Congress thought that ACR's program was so I l

10 good that they needed to impose it on all facilities. So  ;

l 11 they made it law. Congress spoke and said voluntary isn't 12 good enough. We want mandatory because we want to protect I 13 every woman when she goes for her mammogram.

14 You need to be clear about what you consider 15 to have a low risk. You need to be clear to say that this

)

16 is a low risk, but it is not a no risk. That )

I 17 misadministrations could occur or some problem could j 18 occur. There will be some incidents that may occur, but 19 we think that the overall risk is low.

20 So I would suggest as a framework for your 21 discussion on what you want to regulate, what you want to 22 regulate tightly and what you want to regulate perhaps 23 more loosely, that you group medical uses into a low and 24 high risk, inherent risk, and then you also have a 25 category for the probability of an incident occurring, and l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005 0701 (202) 234 4433

269 1 a column for tha consequences if the really bad thing

'gw 2 happens.

3 So that you take into account more than just 4 the inherent risk, but probability and consequences are 5 also considered.

6 I think then you need to consider the 7 competence and the control of various handlers, who they 8 are certified by, what qualifications they have. You need 9 to consider what voluntary standards are out there, and 10 who doesn't comply with those voluntary standards.

11 I keep hearing some sort of dismissal. Well, 12 you know, those states that don't have an agreement state

,_ 13 program or don't have a strong radiation control program, o

\ 14 there are just those states that have very few population. l i

15 Well, don't those people in those states 16 deserve quality medical care, just the same as those that 17 have a good state program? So if you are going to dismiss 18 those kinds of -- if you are going to dismiss Wyoming, you 19 have to be conscious about it and you have to say why you 20 are willing to do it.

21 To get to Larry's question about why now and 22 what's the difference between 1979 and now, I think the 23 why now is clear to me. We have realized that Government 24 can't do everything for everyone. We have realized that 25 the cost of a government that does do everything for NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-443? WASHINGTON, D.C. 20006 3701 (202) 234 4433

270 1 everyona in cetronomical. So the why now is because we i 2 can't support regulations that accomplish everything.

3 There's also an issue of health care costs 4 containment that I thought would come up from you guys, 5 not from me. So when we make this chart that I am 6 proposing on various medical uses, I would suggest that we 7 also add a column that describes the cost of complianct 8 for the facility to come into compliance and the cost of 9 an enforcing agency, and that we leave blank who that 10 agency is. It could be a state. It could be various 11 federal governments, it doesn't matter. It's just the 12 cost of that enforcement.

13 What do you think?

14 CHAIRMAN STITT: You have stunned the 15 committee. They are just enraptured. We have got a great 16 group.

17 Lou, you were next in line.

18 MEMBER WAGNER: I would like to address some 19 of Jill's comments. One of the comments was why do that, 20 I do that anyway, in terms of some of the comments that

. I 21 have been made around the table regarding regulation and l

22 why it isn't warranted.

23 My comments were zerced in on regulation that 24 provides no meaningful benefit. It's not a comment of I 25 do that anyway, why do that.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON D.C. 20005-3701 (202) 234-4433

271 1 Wa do many meaningless wipe tests. You know,

,'^3 2 a package comes in. I can tell whether it's damaged or i

\ /

3 not. I can see whether it's dripping or not. Why am I 4 doing all these things. I have never had a problem in all 5 the years we've been working. It just doesn't make any 6- sense.

7 ALARA doesn't make any sense to me as a 8 regulation, in doing all the documentation and all the 9 programs, and writing all this stuff and doing it all. It 10 just doesn't make any senses, but it's a great principle.

11 You know, I really would like to see that go on.

12 As far as the ACR mammography program is i

,_x 13 concerned, that's a great example of the regulatory system l

[ \

x_ / 14 that's now gone awry and become burdensome on its people.

15 The amount of regulation in the new proposed rules are l 16 absolutely absurd in some places. The kinds of 17 prescriptive junk they are putting in is unnecessary. I 18 am furious over it.

19 It's a fine example of how you gave a little 20 authority to a regulatory body, and they just took it and 21 went out of control with it.

22 So yes, it did a good thing in terms of 23 raising consciousness. What really did the good thing was 24 the ACR voluntary program. It raised a lot of eyebrows.

g t 1 (v j 25 It showed people you can do better quality. It was the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

272 1 one that really did the great impact on things. Congress 2 wanted to say let everybody do it. Then they made it a i

I 3 regulation. As soon as we put it into the hands of people 4 who didn't know what they were doing, they went overboard 5 with it. They are continuing to go overboard with it.

6 As far as categorizing things into high risk 7 and low risk, I don't think that's proper. I think we 8 should categorize them into known risk and no known risk, 9 where levels we have we know there's a risk. These high 10 dose rate things, we know there's risks with these things.

11 We know it. We can document it. We can show it.

12 We can't show it down there. We don't know 13 that it's no risk. We don't know that it's low risk.

14 It's no known risk.

15 So I would like to categorize it into those 16 categories. I think that's more appropriate.

17 I agree entirely with your two comments 18 regarding the competence and control of handlers. I think 19 we have to focus on that. It's a very important issue.

20 You are going to find it's a very difficult issue.

21 Also, the can't afford the zero incidents, I 22 think that's very important, because what you have 23 introduced there is what has been implied in everything 24 that we have been saying. That is, even in the 25 regulation, there's a cost benefit analysis that must be I I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE 13 LAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

273 1 looked at. It's absolutely true.

f-sq 2 That's why I have been trying to emphasize

\s)

(

3 that I do an awful lot of stuff for which there is no benefit, but there's a lot of cost.

4 Cost in terms of 5 personnel and time, and even the efficiency of which you 6- do your operation.

7 So I would like to propose an amendment to 8 your recommendation. That'is, I would like to substitute 9 instead of.high risk, I would like to say that the NRC 10 will regulate the radiation safety of patients where 11 justified by the known risk. I would like to say the 12 known and documented risk to patients, and where voluntary 13 standards or compliance with the standards are inadequate.

14 There, we are really talking about.the. issue.

13 It's where we know there's risk. That's where we have to 16.' justify it.

17 If we don't know that there's a risk and we 18 have to debate whether there's a risk about this whole 19 thing, and we've had over 100 years of experience with 20 these things, when are we going to stop? When are we 21 going to stop worrying about these things? So I think 22 it's an important time to give that message to the 23 Commission.

24 We should focus on those issues and really O 25 emphasize those issues where we know there is a risk.

( For NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

-(202) 234 4433 WASHINGTON, D.C. 200( 5 3701 t'42) 234 4433

274 1 thocs aracs where wo don't know there's a risk, yse, wa 2 can use some guidelines, but we have got to be more 3 general than what we currently are. We can not be as 4 specific and prescriptive with the costs that are 5 associated with these things for very little benefit.

6 DR. ALAZRAKI: Would you accept known high 7 risk?

8 MEMBER WAGNER: I don't know what you mean by 9 high. That's my problem. I have got to have some --

10 DR. ALAZRAKI: Known risk leaves it open for 11 low as well as high. l 12 MEMBER WAGNER: Known and documented is what I 13 would choose. i 14 DR. ALAZRAKI: I think for general public 15 understanding to say known high risk is a little bit 16 clearer.

17 CHAIRMAN STITT: That known could also 18 encompass known low risk if we're not specific.

19 Now I also believe that we're not going to sit 20 here and define what this means. Larry is going to keep 21 beating me on the head. I want to be finishing here soon.

22 So let's address this amendment. It has not been seconded 23 because we are still discussing the amendment. Then I 24 know Jeff had a comment.

25 MEMBER NELP: Would established be better?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M WASHINGTON, D.C. 2000 53701 (202) 234 6

275 4

1 Known catchliched risk? Bscause thD BEIR report clearly 2 does not establish anything for doses below 15 rad or so.

/

V i 3 I mean they don't even want to quote these things. They 4 only use --

5 DR. ALAZRAKI: Or established high risk or I 6 known high risk.

7 MEMBER WAGNER: Everyone wants to say the word i

8 high in there. I think we're going to have a lot of 9 trouble with that. I think it's going to come back and i

10 bite us if we use that high.

j 11 CHAIRMAN STITT: We can define --

12 MEMBER WAGNER: We are going to have to at 13 least define it or something.

(D l lh 14 CHAIRMAN STITT: But we can define it at a i f 15 later time. I mean that's a long -- a known risk still 16 implies all kinds of risk, low, high. It only rules out 17 unknown.

18 MEMBER KANG: Can I just comment? I am just 19 worried about if you classify as known and not known, 20 there may be a known but high risk, we have no record of.

1 '

i 21 Then you may eliminate it because it's not known.

22 MEMBER WAGNER: We have been studying this 23 stuff for over 100 years. We're worried about the effects 24 of radiation for effects that have been looked at for well

.g / 25 over 100 years now. God, if we don't have enough i v I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

.f

276 1 information about whether thsre's a big high risk out 2 there, I don't know. That's seems awfully strange. I l 3 don't know what you would classify as a high risk. It 4 certainly hasn't been detectable amongst all the work that i

5 we have done for some time. l 6- MEMBER KANG: I think that still I would refer 7 to classify between high and low risk, although we may l

8 have some disagreement what is high and what is low. I 9 think we are all talking about the radiation safety, so 10 that it depends on what kind of radioisotope you --

11 MEMBER WAGNER: I am just afraid we are going 1

12 to lose a little credibility with the commissioners if we l 13 sit there and tell them high risk, and they interpret high 1 14 risk as meaning something like radiation burns or 15 something like that. That is not what our intention was.

16 So I am having trouble with this word high. I 17 don't like the word high because I think it's going to i l

18 bite us later in terms of our credibility in what we're 19 saying.

20 DR. ALAZRAKI: How about known consequential 21 risk?

22 MEMBER NELP: Well, its adverse effect on the 23 patienc's health is the risk we're talking about. It 24 could have an adverse effect on the patient's health. The.

25 only time we know that is when we're doing therapy if we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

277 1 cerew up. So that's may have an adverse effect due to 7-~g 2 radiation exposure, rather than high risk, then you avoid

\

\') 3 --

4 CHAIRMAN STITT: Well, consequential is a 5 modifier that doesn't have that graphic between a low and 6 high, which also are pretty soft. We need to keep --

7 right now I have got probably five different things.

8 Known consequential risk is the most recent amendment.

9 MEMBER NELP: Documented adverse.

10 CHAIRMAN STITT: We're going to keep going l 11 until we get this.

12 MEMBER GRAMAM: I need to address one of Lou's 13 comments. I don't think le run a risk of being 4 7x '

k_, 14 embarrassed by the commissioners to the extent that we 15 would send this recommendation with an agreement that this l 16 committee is proposing to have a significant role in then 17 working with staff to define what high risk is.

18 To me, the two go togetber hand in glove. I 19 would not recommend this change to a medical policy 20 statement of the NRC without having this committee go on 21 record that we look forward to having an opportunity to 22 work with the commissioners and staff in the future to 23 assist in the definition of what should constitute high 24 risk.

/

(h) 25 But the word high was carefully chosen to NEAL R. GROSS COURT REPORTERS AND TRANSCRMERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

278 1 oliminato an entiro cet of low risk things that are out 2 there. I'm trying to raise the bar to a point where we 3 can get into a meaningful debate faster on those things 4 that need to be regulated.

5 If we get into known, if we get into 6- consequential, you have introduced enough ambiguity in the 7 language itself. Because I would strongly recommend that 8 this ought to be the point of public discussion versus 9 direction setting issue paper number 12, which I can't 10 understand after five readings.

11 This, I think you could get public comment on 12 that will be over a broad spectrum, and that's 13 significant. So I would, having made the original motion,  ;

14 I would recommend we stay with high risk.

15 CHAIRMAN STITT: We have a comment on the 16 floor that hasn't been seconded. John's original motion 17 was to modify the second medical policy statement to say 18 justified by the high risk to patients.

19 Now any other commentary? That's where we are 20 right now.

21 MEMBER SWANSON: I still have a problem with l

22 this in that I intend to treat a patient for thyroid 23 cancer, that patient is going to be exposed to a high j 24 risk. But that's a justified high risk. Okay? I don't 25 think that's where we want the NRC's involvement in those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

279 1 kinds of decisions. That's exactly what I.am saying.

1

,q 2 So I think, you know, I can see where the NRC

-(') 3 might want to be involved in risk to patients that are non l

4 intended risk or non medical risk, but I think that's 5 exactly where the problem is at. You are still going to 6- be involved in medicine if you just leave it high risk.

7 CHAIRMAN STITT: Jeff?

8 MEMBER WILLIAMSON: Well, I am having certain 9 concerns I guess about sort of this whole -- we're trying 1

10 to sort of amend this medical policy statement and get the

?

11 exact wording right, i 12 MEMBER NELP: I have a definition for high

13 risk.

(3 7

%/ 14 MEMBER WILLIAMSON: Sorry. I was speaking.

15 CHAIRMAN STITT: Let's get Jeff's comments.

16 MEMBER WILLIAMSON: Yes. I am not sure, maybe 17 we've kind of gotten past the point of profitable return 18 on this. Maybe we just sort of need to articulate a 19 general set of principles and not try to get every exact 20 word right.

21 I think what we are trying to say is something 22 like the following. That the NRC should not make 23 regulations that basically constrain medical practice 24 unless patient welfare is seriously jeopardized on a O

25 significant scale by basically avoidable technical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

280 1 mictakoa.

2 Maybe that's a very complicated thing, but 3 think about what NRC does now. They really do not 4 regulate, for example, whether nuclear medicine physicians 5 or radiation oncologists give iodine 131 for the 6- appropriate clinical indication. They really don't care 7 about that. They presume that as long as an authorized 8 user, regardless of whether said user has a brain in his 9 or her head or not, if they sign that prescription, that's 10 legally valid medical use of that radionuclide.

11 They are concerned about a very narrow class ,

1 12 of possible technical errors that really have to do with 13 the misunderstanding of this prescription, for example, or 14 the fact that the labeling might be incorrect or the 15 calibration might be incorrect, or a bit of it may get 16 spilled, et cetera, et cetera, et cetera, 17 Really that's kind of what the focus of the 18 regulations are right now.

19 CHAIRMAN STITT: We are having trouble with 20 point number two. Several people have said one and three 21 they are willing to leave untouched. If we are not able 22 to come to a consensus on point number two, do we need to 23 make a statement that our issue -- I don't want to put 24 words into your mouth, but is our issue with medical 25 policy statement --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

- .. -. . _. . ~ .. - - . - . - -

281 1 MEMBER WILLIAMSON: Can I finich one of my

/'"} 2 statement? One more point to sort of wrap up what I am

(/ 3 trying to say.

4 I think if we sort of put together what Dr.

5 Lipoti and what Lou have said, kind of together, you know, 6- there's a sort of regulations that are now on the books 7 that address technical endpoints that many consider 8 burdensome and restrictive of medical practice. If we 9 kind of make a list of them, like the QM rule, that is 10 supposed to get rid of 400 diagnostic misadministrations a 11 year.

12 What are the medical consequences and risks to

,- 13 those 400 patients who get these misadministrations?

/ s

_- 14 Let's put a number or at least a qualitative clinical 15 assessment of what that risk is, and let's go through all 16 of the other major classes of regulations that now impact 17 on the use of -- excuse me, diagnostic use of 1

1 18 radionuclides, and make a sort of similar assessment. I 19 Suppose the package is contaminated, one out 20 of 50,000. What are the consequences?

21 MR. CAMPER: I must clarify something for you 22 again, just so there's no confusion for everyone at the 23 table. The QM rule didn't get rid of 400 diagnostic 24 misadministrations. It did, but not because of the

( j 25 objectives in the rule. It did because it elevated the NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

282 1 thrschold for r?/.cgnostic misadminictrations to Sr, total 2 effective dose equivalent, 50r individual organ. That's 3 why they went away, because they elevated it.

4 MEMBER NELP: But you see, that level of 5 diagnostic misadministration is absolutely infinitesimal 6 if you look at it on a percentage case compared to all 7 other misadministrations of other pharmacologic agents.

8 There's no way you can regulate out of that. You can't 9 regulate below that. Human error exists. That's the 10 fallacy of the whole thing.

11 MEMBER WILLIAMSON: I guess what I am trying 12 to suggest is if we sort of march through the current 13 endpoints in the regulations and assign a risk. Suppose 14 you don't have the QM rule and there.are X number of 15 misadministrations for this modality. So what? What's 16 the risk to public health in terms of the exposure, 17 average exposure being raised to the general public, 18 what's the risk to the individual patients. I have the 19 sense that's what they want from us, is to nort of go 20 through that kind of an exercise.

21 CHAIRMAN STITT: I'm not sure we are going to 22 get to a consensus here. John has a comment.

23 MEMBER GRAHAM: Well, just to clarify. The 24 reason for proposing to address direction setting issue 25 paper number 12 and the Commission's preliminary views NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

283  !

1 that they want higher risk activitico, it chould bo n s 2 primary focus of efforts.

4 3 The motion on the table was to set a threshold ,

4 that will give us a guideline if they accepted it, that 5 for the next two years, that's what we will be debating.

I 6- This is low risk. We argue it. We document it to staff.

1 4

7 They can promulgate that as a revision to the regulations 8 and it goes away.

9 CHAIRMAN STITT: Let me read to you a

. 10 suggested definition of high risk. High risk being 11 important here as a phrase just because that's what the ,

12 motion is.

I 13 High risk. Pay attention, folks. ' Potential

\s / 14 adverse effect on the patient's health due to excessive 4

15 radiation exposure resulting from inadvertent technical or i

16 human error. Any comments?

17 MEMBER KANG: Say it again, please.

18 CHAIRMAN STITT: Potential adverse effect on 19 patient's health due to excessive radiation exposure i 20 resulting from inadvertent technical or human error.

21 MEMBER NELP: Not inadvertent, just technical 22 or human error.

23 CHAIRMAN STITT: And if this is too much 24 dstail, we simply are going to have to let it be. Lou?

,' ( 25 MEMBER WAGNER: That's to me unacceptable I

NEAL R. GROSS COURI REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433

284 1 baccusa of tha word potential. I meen anyons can argue 2 that even the smallest dose has potential risk. It really 3 doesn't get out of the question --

4 MEMBER NELP: No, no, no. Adverse effect on 5 the patient's health from excessive radiation.

6 MEMBER WAGNER: Yes. So? One millirem. That 7 was excessive.

8 MEMBER NELP: No, no, no, no, no.

9 MEMBER WILLIAMSON: One millicurie. That was 10 excessive.

11 MEMBER GRAHAM: As a procedural point, I would 12 recommend that we carve out some time tomorrow morning and 13 debate a paragraph of clarification of what high risk 14 represents to this committee.

15 CHAIRMAN STITT: Well, I hate to do nothing.

l 16 On the other hand, if we do something now, people are

{

17 getting tired and fussy.

18 MEMBER WAGNER: I withdraw my amendment then, I 19 Madam Chairman. I 20 CHAIRMAN STITT: Well, it wasn't seconded, so 21 it's kind of hanging out there right now. But I am 22 concerned because we can't go away with not making some 23 comment to the Commissioners on that. I feel strongly 24 about that. Obviously there are very strong opinions 25 based on a lot of expertise that we have gathered here.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHNGTON, D.C. 20006-3701 (202) 234-4433

285 1 Naomi?

f- 2 DR. ALAZRAKI: I think that the most important i

s 3 thing that has come out of today's deliberations is that 4 we are sending back our restatement and reconfirmation of

\

l 5 what the Committee recommended the last time around, which 1 1 ,

. 6 raises a question about what the Commission -- how the 7 Commission views its advisory committee, this advisory I 8 committee. i 9 In other words, we're saying this is the best l

10 we could do. A tremendous number of hours went into  !

11 considering these issues, and this is what we came up 12 with. This isn't the committee decided not to modify J 13 that. That's the most important thing that came out.

/ \

( ,) 14 This issue of whether we modify this statement 15 with high risk or not, I don't, I mean it doesn't seem to l 16 me that there's an urgency to do that right now, although 17 I am in favor of it. If I were on the committee and could l 18 vote, I would vote to do it. But I'm not. But somehow ,

i 19 that pales compared to I think the other stronger 20 statement.

21 CHAIRMAN STITT: Okay. You're making us feel '

22 better about ourselves. Larry has a comment.

23 MEMBER GRAHAM: I feel compelled to point out 24 as well. This is a real important procedural point. She p

25 would therefore not be authorized to second the motion.

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

286 1 MR. CAMPER: Madam Chairman, if I may, lot m3 l 2 offer a suggestion. In the interest of time and in the l 3 interest of difficulty of the subject, what I have l

4 observed is the following. My question about what is 5 different since 1979 was not to defend, it was to 6- challenge and stimulate. I think it did that.

7 What I hear the committee saying, and I think l

8 you could craft a motion fairly easily that would say 9 something like the following. This is purely a 10 suggestion. That in considering the assignment of risk or 11 the appropriate level of regulation to be applied to the 12 medical use, that a re-examination of the 1979 medical 13 policy statement is indicated and that the ACMUI is i 14 prepared to assist the Commission in examination and in i 15 assigning language relative to risk considerations, 16 something of that nature.

17 CHAIRMAN STITT: That was going to be a 18 commentary of mine. If we are having trouble with 19 details, I do think it would be appropriate to bring up 20 this issue that's already in the regulations and we keep 21 going over it, meeting after meeting after meeting, the 22 " intrusion" into medical practice as well as point number 23 two.

24 Now you seem to be Robert's rules of order 25 over here. We had a motion on the table, but it's not h

NFJAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

287 1 been seconded.

2 MEMBER WAGNER: I second.

(o )-

U 3 CHAIRMAN STITT: All right. It's now 4 officially seconded. Is this committee willing to vote on 5 that, either up or down? ,

l 6 MEMBER NELP: Now or tomorrow? -l 1

7 CHAIRMAN STITT: Or you want to let it rest  ;

8 and defer until tomorrow? Because-I don't think we're 9 done with this. We're going to have to reschedule or 10 reshuffle some things. )

i 11 Do you have to table something formally in l 12 order to put it off? Can we just elect to keep discussing 13 it?

O 14- MEMBER NELP: I move that we table the motion 15 until an appropriate time when we fulfilled the 16 discussion.

17 MEMBER GRAHAM: Support. -

18 CHAIRMAN STITT: All right. We're going to l 19 vote on the element of which is tabling the motion at 20 hand.

21 DR. ALAZRAKI: If you are going to bring this 22 up again tomorrow morning, why don't you --

23 MEMBER NELP: You can't vote tomorrow either.

24 DR. ALAZRAKI: No. I know that. But why 25 don't you just leave it open? Leave it on the table if

%/

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

286 1 you cra going to ba diccuccing it again tomorrow.

2 MEMBER GRAHAM: I'm not sure we can adjourn 3 without tabling it. I don't know Robert's rules well 4 enough, but I don't think we can adjourn the meeting with 5 a motion on the floor.

6 MEMBER WAGNER: I think that's right.

7 CHAIRMAN STITT: Say that again? I wasn't 8 paying attention.

9 MEMBER GRAHAM: I don't think you can adjourn 10 the meeting with a motion on the floor. So it has been 11 moved to table the motion. I have supported the motion to 12 table.

13 CHAIRMAN STITT: So we're going to vote on 14 that, all right. We are going to vote on the motion, l 15 which is to table. We are going to vote on tabling the 16 original motion made by John. We will have to find a way 1

17 to discuss this tomorrow morning. So I am going to ask 18 the staff to figure out how that will be done.

19 Those in favor of tabling the motion, hands 20 up.

21 Those opposed?

22 All right. This motion is tabled. We'll keep 23 on it tomorrow so we can add some additional comment to 24 our notes to the commissioners.

25 Larry and Sally, are we able to do the -- I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 13.23 RHODE ISLAND AVE., N.W.

(202) 2344 433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

289 1 gutes wa arc. Wa era eble to do the last three tidbits 7-s 2 between now and 5:00.  ;

(

\s -) 3 MEMBER WAGNER: Was it unanimous, the vote?

4 CHAIRMAN STITT: Yes. I saw no negatives.

5 Memorandum of understanding with US Food and i

6- Drug Administration.

i 7 MR. CAMPER

Well, this is light and airy by 8 comparison. No motions needed. No consensus required.

9 I want to quickly give you a status report on 10 l the memorandum of understanding which we have with the -

11 U.S. Food and Drug Administration.

12 We have had a memorandum of understanding in 13 place now for approximately three years. This MOU was put O

( ,) 14 in place since both the NRC and the FDA regulate medical 4

15 devices and radiopharmaceuticals containing radioactive l

16 device. There was a feeling that there was a need to i

17 enhance the level of communication that had been in place 18 between the two agencies for some time. In doing so, we l

4 19 want to clarify the roles of each agency. We wanted to 20 formalize and facilitate information flow, and to develop 21 mechanintfl of exchange.

22 As a result, we entered into the MOU in August l

4 ,

23 As I mentioned, the duration '

of 1993, the 26th of August.

24 was three years. Part of the memorandum of understanding

[)

V 25 was that each year there would be a meeting between senior i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

i WASHINGTON, D.C. 20006-3701 (202) 234 4433 (202) 234 4433

290 1 1 loval ex cutivcc of both cgancico in which major issues 2 l would be brought to the table for consideration. If there  !

l 3 was something on the minds of FDA or NRC we could talk  ;

i 4 about them at that level.

5 Then at some point, we were also during those 6- annual meetings, challenged to evaluate the effectiveness 7 of the MOU. We have felt all along that the MOU was 8 working very well.

9 Our staffs communicate on a weekly basis, 10 depending upon the issues and what's going on. We have  ;

11 had the annual meetings, and said they've gone very well.

12 And then the MOU also requires that as we l 13 approach the three year timeline for the MOU, that we make l

14 a determination as to whether or not it should be renewed.

15 During the annual meeting on the eighth of August, 1996, I

16 both agencies' liaison officers agreed that the MOU should 17 be renewed.

18 The staff has subsequently prepared a 19 Commission paper or is now preparing a Commission paper 20 that we will send to the Commission for its consideration, 21 in which we suggest that the MOU would te renewed.

22 We will be publishing, assuming the Commission 23 agrees with that, and I would be highly surprised if thef 24 didn't, we will publish a Federal Recister notice that 25 will announce that the two agencies have agreed to renew h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433 m

291 1 the m;morandum of undarstanding.

g 2 We provide this to you for your awareness. We

)

3 think the MOU is working very well. We look forward to 4 renewing it. Any questions or comments on the MOU?

5 CHAIRMAN STITT: John?

6' MEMBER GRAHAM: Is there anything in the memo 7 of understanding that would benefit the future operation

)

8 of this committee that we ought to know about? We have 9 nothing with regard to the memo itself.

10 MR. CAM?ER: We certainly -- I don't' think 11 so, but we certainly would be happy to provide you with a 12 copy of the MOU.

13 MEMBER GRAHAM

I would just encourage staff

' [~'N l i \s-) 14 to highlight anything in the memo that would be germane to 1 15 our function.

4 16 MR. CAMPER: We will be happy to do that.

17 MEMBER WAGNER: Will we be able to review this

18 at the next meeting and go over that information at the 19 next meeting and have an effective input as to any

] 20 consequential changes we might recommend to that memo?

21 MR. CAMPER: Interesting question. I don't

$ 22 think we realized until now that there was an interest in 4

23 the advisory committee actually impacting the memorandum 24 of understanding with the FDA. We could certainly explore f

25 that. I don't see why not, frankly.

J NEAL R. GROSS

, COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

1 (202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

l i

292 l 1 MEMBER GRAHAM: Right. There may not be any 2 reason we should get involved. I'm just asking staff.

3 MEMBER WAGNER: That's right. I mean if there 4 are questions, do we have any time and would it be 5 meaningful? ,

6 MR. CAMPER: Well, the Federal Recister notice t

7 that will be published will announce the decision of the 8 agencies to renew the MOU. I would assume the Federal 9 Recister notice would also call for any comments from the 10 public if they would like to comment.

11 But I certainly can explore the potential of 12 getting it to the comm!.ttee for its review. I don't think 13 we realized that there was an interest by the committee in 14 doing that. But I don't see a reason why not, frankly.

15 MEMBER KANG: I would like to comment on that.

16 This inter-agency memo, I'm not really familiar with that.

17 But as long as this is inter-agency memo, you may review l 18 it, but I don't think you can change it. This is just 1

19 government agency memo.

20 CHAIRMAN STITT: Naomi, you are over in the 21 dark. I can't see you.

I 22 MR. CAMPER: Well I think the point is, you're 23 right. In theory, the committee could say don't renew the 24 MOU. If you take the extreme, the NRC could say no, we 25 want to renew the MOU. But the point is, I have heard two NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20E3701 (202) 234-4433

293 1 things. The committee would lika to hevo cn awarenn2= of

( 2 what the MOU says. Number two, the committee would like

\.'"3) 3 to have the opportunity in that awareness to perhaps 4 provide comments about the MOU that could be considered by 5 the NRC in renewing the MOU. That seems to be entirely 6- appropriate.

7 DR. ALAZRAKI: I think it is important that 8 everyone understand what the MOU says and what its 9 limitations are, but my understanding is that it simply 10 says we don't want dual regulation. There has to be some 11 agreement between FDA and NRC if they are duly regulating 12 something and perhaps making life more difficult for the 13 medical practitioners.

(Q I 14 MR. CAMPER: It actually has three primary 15 objectives to it, as I recall. One is this question of 16 avoidance of dual regulation. Second is the capacity to 17 openly exchange information as rapidly as possible.

18 Thirdly, is in those cases when proprietary information is 19 involved, that the administrative mechanism is in place to 20 allow a set exchange while protecting the proprietary 21 nature.

22 CHAIRMAN STITT: Other comments, Jill?

23 MS. LIPOTI: I think the reason that we might 24 have our sensitivity raised for a memoranda of 25 understanding is because the NRC has signed a MOU also C

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 23W

294 1 with thn EPA, for instanca, on various cgrcement on

{

2 standards. l' 3 When you have two big federal agencies talk to 4 each other, the rest of us don't get a chance to play. So 5 we are particularly sensitive to issues. I am very glad 6- that you are exchanging information freely, and that's 7 very important. But I would like to see what's in the 8 MOU.

9 MR. CAMPER: Okay.

10 CHAIRMAN ETITT: All right. We do have a hard 11 group here.

12 MR. CAMPER: That's a tough crowd. Okay.

13 Thank you.

14 CHAIRMAN STITT: Next is Sally Merchant, guide 15 for the preparation of applications for medical use i

16 programs.

17 MS. MERCHANT: You'11 have to excuse me if I i l

18 seem a little out of it. It's kind of getting late in the I I

19 day.

20 Preparation of applications for medical use 21 programs. This is the document that we worked on last 22 year that will replace regulatory guide 10.8. Several of 23 you worked on parts of that. This is just an update of 24 where we are with that, the modules. l 25 What we have done is develop modular guidance ,

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20(XE3701 (202) 2344433

295 i

i for those who aren't familiar with it, specific to each l l

'~

2 modality of use. It is designed to augment Reg. Guide 3 10.8 in preparation of licenses.

' i

, 4 This, just to be clear, this was not designed 5 as part of any revision or anything. It was just that i

6' there was perceived to be a hole in guidance in the i 7 interim for filling out applications for medical use.

8 We had very little guidance out there for l

i 9 brachy therapy, for some of the newer -- for after l 10 loaders, for any of that. 10.8 is basically a nuclear

11. medicine guide.

12 So we saw a hole and we attempced to fill it.

~s 13 We used the advisory committee to help us to do that.

\sI 14 This is only interim guidance. It shouldn't really 15 represent anything new. As I said, it was worked on by 16 this group.  !

I 17 It will be published as a draft NUREG for j 18 comment somewhere around January. It's with the tech 19 editor right now. It has not, for those of you who worked 20 on it, it has not substantially changed since you worked 21 on it. It takes a lot of time to put one of these 22 together, especially as big as it is, to make editorial 23 change. But contents wise, it's probably very much like 24 the last time you all saw it.

10

( _, ) 25 The modules include mobile nuclear medicine.

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 2344433

1 296 1 Wa had a void tharo. Rndiophr.rm ceuticcl thercpy. Brcchy 1

2 therapy. High dose rate. Teletherapy, and gamma l

3 stereotactic radio surgery.

4 Now this guidance was reviewed in spring of 5 1995 by all of the internal NRC offices. It was sent out. 4 6' Everyone made comments. We included those comments.

l 7 Then in fall of 1995, we had an ACMUI I 8 subcommittee of selected individuals, came here to 9 headquarters in meetings. There are transcripts of those i

10 meetings should anybody want to see them. Changes were  !

11 suggested. We put the changes in.

12 As I said it has gone to the editor and should 13 be published in probably January. What do you think, I 14 Larry? Around January? Ol 15 MR. CAMPER: That's probably realistic. )

16 MS. MERCHANT: That's probably a close one.

17 Are there any questions on this particular document?

18 As I said, I want to reiterate that this is 19 not new guidance. It is not any kind of revision to part 20 35. It does not represent any new requirements. At least 21 it shouldn't represent any new requirements. It just 22 clarifies what you need to do to apply for a license.

23 Many of these things, in fact almost all of 24 these things, you had to do, but it took longer to get the 25 license done because the licensee wasn't aware of what we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

1; 297 l 1 wanted baasd on what was out there. So now this just 7-~s 2 clarifies it. Any questions?

Nm ,- 1 3 MEMBER FLYNN: Yes. I have one.  ;

l 4 MS. MERCHANT: Yes. i l

5 MEMBER FLYNN: You said what the licensee is 6 required to do to apply for a license.

7 MS. MERCHANT: Yes. I l

8 MEMBER FLYNN: What about if the licensee l l

'9 already has a license. Is this guidance on which, for j 10 example, inspections would be based or is this more a 11 trial balloon to be out there for licensees to take 12 advantage of, sort of the forerunner of the revisions of 13 part 35.

O 14 MS. MERCHANT: No. l 15 MEMBER FLYNN: So if you find, for example, if 16 it's a draft NUREG, then if you discover problems with it 17 as it's being used out there, then you would be using that 18 in terms of in the future? You see that as a way to get 19 to part 35?

20 MS. MERCHANT: Actually no. This was 21 developed really only to fill that hole. Many of these 22 requirements, especially for some of the low risk probably 23 will go away. But for now, because the regulations are 24 still on the books, and people are applying for licenses, O

i s v; 25 the information really needs to be provided in a succinct NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHWGToN, D.C. 200054701 (202) 234-4433

298 1 uay co that if you wanted to apply for cn NRC lic:nea, you 2 would know what you needed to do for your modality.

3 As I said, we had a real void in regulatory 4 guidance.

5 MEMBER FLYNN: No. I agree. The 10.8 was way 6 out of date.

7 MS. MERCHANT: Way out of date.

8 MEMBER FLYNN: What's the difference between a 9 draft NUREG and a NUREG? Maybe I didn't understand.

10 MS. MERCHANT: Draft is for comment. People 11 may want to make comments on it.

12 Larry, why aren't we doing it as a final 13 document?

14 MR. CAMPER: Well, several things. First of 15 all, we intended to do this. There was a void in 16 guidance. Some of it simply didn't exist. Some of it was 17 inadequate.

18 The regulations are on the books. We have a 19 set of expectations when we review license applications. l l

20 We felt it was important to convey to the regulating l 21 community guidance that will assist them in applying for 22 licenses.

23 We were originally going to do this project as 24 a set of modules to regulatory guide 10.8. A regulatory 25 guide is the guidance that is used to implement the -'

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHWGTON, D.C. 20005 4701 (202) 234 4433

299 1 regulation. ,

.l 2 We opted to publish it though as a NUREG for 3 public comment in the final analysis, because frankly, we 4 felt that if we go out now with eight modules of guidance 5 as an adjustment to Reg. Guide 10.8, there could be the 6 perception by the regulated community at a time when wait s

7 a ininute, you are evaluating the medical use program and 8 you are trying to decide as a regulatory agency what you

9 want to do about it, but look, you just put on the street eight new guidance modules in a reg guide.

1 10 We were 11 concerned that the perception would be you really ought to i

12 hold it all. Well, the fact of the matter is, we are.

13 But that did not address this informational i

'( ,) 14 void. So what we did was we put it into the form of 15 NUREG, which is purely guidance. It does not have the 16 regulatory stature of a regulatory guide,and we're i

17 soliciting comments. Those comments will then be used to 18 address the guidance.

19 What I think will happen most likely is one of 20 two things. Either it will remain a draft NUREG for a 21 prolonged period of time as we work our way through part 22 35 and then subsequently revise, that would be revision 23 number three to the reg guide to coincide with whatever 24 part 35 looks like. Or the NUREG, after solicitation of 25 comments and consideration of comments, could be published N.)i NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 23N WASHINGTON, D.C. 20005-3701 (202) 234 4433

300 1 as a final NUREG.

2 But the difference between a draft NUREG and a 3 final NUREG is simply the opportunity for comment.

4 MEMBER FLYNN: So in some ways, it is a trial 5 balloon. It could be very helpful in revising part 357 6' MR. CAMPER: It certainly could be helpful. I 7 mean it certainly could be -- well, it depends on what 8 part 35 ultimately looks like. But certainly some of the 9 guidance that's in the NUREG could ultimately be 10 incorporated into the regulatory guide.

11 CHAIRMAN STITT: Other comments? Jeff?

12 MEMBER WILLIAMSON: How does it, for the 13 remote after loading brachy therapy, how does it differ 14 from your licensing guide? What is it, 86-4?

15 MR. CAMPER: It is 86-4.

16 MS. MERCHANT: It pretty much is 86-4.

17 MEMBER WILLIAMSON: Did you just incorporate 18 it into there?

19 MS. MERCHANT: Pretty much. Bob revised it, 20 added some additional things. Do you have anything to 21 add, Bob? Come to the microphone.

22 MR. AYRES: Yes. Bob Ayres. A few minor 23 changes mainly to clean up comments that we had gotten in 24 the interim between publishing 86-4 and revision. The one 25 that comes to mind got read as a requirement for checking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

'301 1 the source homogsnaities. That's kind of silly any more g-'$ 2 with the small sources.

3 The other thing we did is we eliminated the 1

4 RSO. Now it's medical physicist and physician, not the l

2 5 RSO present during treatment.

6' Those are probably about the main two things 1

7 that come to mind. Then a cleaning up the language and 8 putting it in a modular format.

l 1

9 Like I said, the subcommittee reviewed it and '

Y 10 we incorporated their comments. I 11 MS. MERCHANT: Yes. Unfortunately, a policy l 12 and guidance directive like 86-4, those people that are  !

l

,,, 13 part of it, and I'll say it, the in community, know it I m- 14 exists and can ask for it. But many of the average 15 licensees are not aware of policy and guidance directives.

16 Whereas a draft reg guide will have much more free 17 distribution.

18 MR. AYRES: I guess one other comment I would 19 make, Sally, is on your review, also included in that was 20 an agreement state, saying they provide comments.

21 MS. MERCHANT: I had forgotten that. Of 22 course you did.

23 CHAIRMAN STITT: Anything else on this point?

24 All right. I think you have the last section for the day

(^~h 25 also.

i /

%d NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200054701 (202) 234 4433

302 1 MS. MERCHANT: Okay. Tha quality manignm:nt 2 program and its administration rule, 10 CFR 35.32 and 3 35.33. The effective date was January 27, 1992.

4 We were charged by the Commission at that time 5 to come back in three years and tell them how the 6 implementation went. Just give them a report of what our 7 findings were, of any changes that we saw, and also to 8 make a recommendation whether we thought it ought to be 9 broadened into a more comprehensive quality assurance 10 program that would affect everyone, i

11 The rule was intended to ensure that byproduct 12 material or radiation from byproduct material would be 13 administered as directed by the authorized user physician.

14 The rule modified the notification reporting l 15 and record keeping requirements related to 16 misadministrations. It revised the definition for j 17 misadministration that was in 10 CFR 35.2, and 18 distinguished between misadministrations and lesser 19 recordable events for which reporting to NRC is not 20 necessary.

21 It elevated the reporting threshold for 22 diagnostic misadministrations to 5 rem total effective 23 dose equivalent, and 50 rem effective dose equivalent to 24 an individual organ.

25 It essentially doubled the threshold for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

303 1 therapsutic micadministrction. The previous threshold, 10

, -'y 2 percent is now the recordable event.

i 3 The rule required applicable licensees to 4 establish and maintain a QMP that meets the five 5 objectives that are in 35.32 (a) . One is to prepare a 6 written directive for each administration, to identify the 7 patient redundantly, to check final plans of treatment and 8 related calculations to ensure that they are in accordance 9 with the written directive.

10 A recommendation, not a requirement, is that 11 when calculations are done, especially hand calculations, 12 that a different individual check those calculations.

, ,. 13 Also we expect you to do things like to

/ i k.-) 14 assure, be fairly certain that your computer works 15 correctly. We don't require acceptance testing, but you  !

16 really should know that your computer does what you think 17 it's doing, however you want to do it. We don't tell you 18 how to do that. But you really ought to assure that.

19 Four is that the administration is in 20 accordance with the written directive. Five is that any 21 unintended deviation from the written directive as 22 identified and evaluated and the appropriate corrective 23 action is taken. Again, you all decide what that 24 corrective action is.

tv) 25 The rule required licensees to submit their NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 5 3701 (202) 234-4433

304 1 quality mnnag;mant programs to NRC. NRC contracted with 2 Lawrence Livermore National Labs to review those written 3 programs.  !

4 In April 1994, the results of the Lawrence 1

5 Livermore National Laba review of the submitted QMP showed 6' that of 1,709 licensees, written QMPs that were reviewed, ,

l 7 only two percent appeared to meet the requirements. l 8 Sixteen percent appeared to meet the requirements, but 9 appeared to have weaknesses. Seventy two percent failed 10 to fully meet one or more of the objectives. l 11 The rest of them, the licensees had sent in 12 letters saying we don't use material that meets the rule, 13 requirements of the rule, so we called it a negative 14 declaration. I 15 Just on a comment on these. These were 16 actually reviewed by a medical facility in California by 17 their therapy department. Lawrence Livermore didn't do 18 the reviews. They only contracted the reviews.

19 I will say that, and this is certainly not 20 negative, they did a wonderful job. But we kind of 21 thought they did too wonderful a job. It never occurred 22 to us when we contracted them that they would hold so 23 strictly to the criterion. I really think the results 24 would have been a little better had we reviewed them 25 ourselves.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

.~ . -_ . . . -. - . . . .

305 1 MEMBER WAGNER: Boy, that's an amazing 7

\

2 statement to be coming from a regulatory.

'/ 3 MS. MERCHANT: Think about it in terms of 4 yourself. If you contracted to do a job, you want to do 5 exactly what you said you would do and stay right within l

6' the parameters. I think that they just wanted to do 7 exactly what they thought we wanted them to do. So they 8 really held the QMPs feet to the wire, if that's a good 9 analogy, although a lot of the findings were very factual.

10 We got a lot of QMP that looked like they had 11 xerexed the regs and sent them. That really was not what 12 we intended.

,, 13 For inspection, on August 1, 1994, we put a 14 temporary instruction for inspection of quality management 15 programs in place. Now this was a description of how to 16 do the inspection. It included a checklist for each 17 modality of use.

18 We collected all of that information into a 19 data base and are in the process of analyzing it right 20 now, and comparing it to other data bases like the Office 21 of Enforcement's data base, the Nuclear Materials Events 22 data base, the licensing tracking systems, the inspection 23 follow-up systems.

24 Using a relational data base package right off 25 the shelf, we are able to put them all together and NEAL R. GROSS COURT REPORTERS AND TRANSCRWERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D C. 20006 3701 (202) 234 4433

306 1 compnre them.

2 Now I need to caveat this and say that because 3 of the differences in the criteria of the data collection 4 for the different offices, occasionally the data will be a 5 little out of whack. Whereas one will say there were this 6- many events, they might be off by several compared to a 7 different data base.

8 So the data is a little soft, but it gives us 9 a feel'for what we're doing.

10 The TI data base is hard information because 11 we had control over it. The Lawrence Livermore data base 12 is fairly hard because we had control over it. But as I 13 said, once we start talking about enforcement data and 14 that sort of thing, it's questionable whether there aren't 15 more events than I'm saying.

16 I erred on the side of conservatism. Let me 17 put it that way.  ;

18 But anyway, the percentage of implemented 19 program that did not meet objective one over the two years 20 is seven percent. One of the reasons for that is not that l

21 they didn't prepare written directives, but that the 1 22 contents weren't always what they thought they ought to ,

1 23 be.

1 24 Right up front let me say that we don't l 25 believe we should have been that prescriptive in the f

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

. . . __ _ - _~ ... -_ _ _ _ _ _ . _

307 1 contents.

fw 2 MEMBER WILLIAMSON: May I just ask for l

^(\' ') 3 clarification? Are you saying seven percent of them did 4 not agree with the definition in part 35 or the regulatory 5 guide, or seven percent of them didn't agree with their 6 own written QMP commitment?

7 MS. MERCHANT: We are comparing it to the part 8 35. That's more fair because otherwise we would hold them I 9 to their written program, and most of those are deficient 10 to some extent. So we are holding them to the regulatory 11 standards. They had to meet the requirements.

12 Objective two, three percent didn't  ;

13 redundantly identify patients. When I say didn't A

, 14 redundant, they didn't have a procedure to do it, and they 15 said to the inspector no, we don't do that. l 16 Objective three, which is to check 17 calculations and that sort of thing, 13 percent did not 18 have procedures to double check their calculations. Seven 19 percent didn't have procedures to go back and assure that l 20 what they were supposed to have given they did.

21 objective five, 11 percent did not follow up 22 on reportable events and things of that nature.

23 In addition, 11 percent did not perform a i 24 review of their program within each 12 month period. I fo\ 25 mean that's hard data. They actually did not do it.

NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

308 1 On tha other hand, when compared to the 2 written program, for each modality of use, the implemented 1

3 program met the QM rule objectives more often than the 4 written program, which is why I say we compare to the 5 regulation instead of the written program, because there 6 would have been many more violations.

7 Okay. I hate to even get into this. During l 8 the four years the rule has been in effect, there have 9 been 138 errors in administration that met the 10 misadministration criteria.

11 Now I word it that way for a particular 12 reason. Our data base lists all the events. However, l

13 some of these events turned out -- and they all start out '

14 the same way. If you were to look at this data base, they 15 say a licensee reported a misadministration. However, l

16 when we look into it, many times it is not really a 17 misadministration. All events are not misadministration.

18 They don't all match the definitions. Sometimes in the 19 cases of like for instance patient intervention, it may be 20 found not for good reasons to be not listed as a 21 misadministration.

22 But for brachy therapy, in the event data 23 base, there were 52 events, problems with administration 24 with brachy therapy. HDR, there were 20. For sodium 25 iodide greater than 30 micrecuries, there were 25.

h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005 3701 (202) 234 4433

. . - . _ - - . . . - . - . . . - . - - - - - . - _ . _ _ . . . . . ~ . ~ - . - . - - . .-

i 309 j 1 Therapsutic,-there ware eight. For radiopharmaceutical J

i 2 therapy, there were four. For teletherapy, there were 23.

b 3 For strontium-90 eye applicators, there were six.

1 4 Now let me mention here, this does not include i

5 the ongoing investigation that is currently underway with 4

6- the very large number of strontium-eye applicator 7 misadministrations.

t 8 What's the current number on that, Larry?

4 9 It's over 100,.isn't it? ,

r

! 10 MR. CAMPER: There were two separate events i

j 11 involving multiple patients in Puerto Rico, there was in 12 excess of 100 patients involved. In Hawaii there was 13 something on the order of 14 patients involved.

h 14 MEMBER NELP: I have a question.

15 MS. MERCHANT: Yes.

16 MEMBER NELP: Violations are meaningful if you 17 have a denominator. For instance, this covers a four 18 year. It looks like it covers a four year period. It 19 looks like it's an exemplary record.

20 MS. MERCHANT: -I have a denominator.  ;

l 21 MEMBER NELP: Maybe if you could tell me, I 22 could say if that's true.

23 MS. MERCHANT: I have a denominator.

24 MEMBER NELP: What is-it?

25 MS. MERCHANT: I did not provide the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

i 310 1 denominator, but for each one of thsac, I know the number 2 of written directives for the two year period that was in 3 effect.

4 There seemed to be a problem with the way the 5 data v , entered. I asked on the TI how many written 6' directives for the current year, and how many for the 7 previous 12 months. That was the question that the 8 inspector was asked to fill out. For whatever reason, in 9 many cases it was summed and was only in one column.

10 Therefore, the reliability of that data, I do not feel 11 comfortable adding that up and dividing it by two. That 12 is just not a reasonable thing to do.

13 So I can tell you how many administrations in 14 those facilities that were inspected, how many written 15 directives. Again, there is another problem with that 16 denominator qvsstion because certain modalities have one -

17 - this describes many written directives. It is not 18 necessarily one administration per written directive 19 according to certain modalities.

l 20 So again, we don *t have a really good i 1

21 denominator. j 22 MEMBER NELP: Could you give me a guess of 23 what the denominator is?

4 24 MS. MERCHANT: I wish I had brought the 25 information.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AW., N.W.

(202) 234-4433 WASHNGTON, D.C. 20005 3701 (202) 234 4433

311 1 MEMBER NELP: I maan are we talking about n 1 2 10,000 therapeutic administrations of radioiodine?

V 3 MS. MERCHANT: I can bring you data tomorrow.

4 MEMBER NELP: It's rather important because if l

5 you did -- I don't know how many teletherapies are done in l

6 the United States each year.

7 MEMBER FLYNN: Individual ones?

8 MEMBER NELP: Yes.

9 MEMBER FLYNN: Half a million patients, 10 averaging 25 treatments per patient, so you're talking 11 about 12 --

1 12 MR. CAMPER: Well, I would say the following.

13 We do not know --

I'

( 14 MEMBER NELP: It must be a very low rate.

15 MR. CAMPER: We do not know the denominator. j 16 We don't' know --

17 MEMBER NELP: See that's very important.

18 MR. CAMPER: We agree. We do not know the 19 denominator, but we -- if one goes back to the inception l

20 of the QM rule, it was known at that time that the 21 frequency of occurrence was only 10 to the minus four.

22 MEMBER NELP: Yes.

23 MR. CAMPER: That hasn't changed. The number 24 of misadministrations really hasn't changed. It's a low O i

( l 25 number, no question about it.

%J

_ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

I 312 1 MEMBER NELP: The rcccon I m ntion this, I 2 don't think you can regulate beyond 10 to the minus four. 1 3 I mean there's no way you can do that. Human error 4 exists.

5 The other question I had is in these 6 misadministrations, did you identify any obvious immediate 7 adverse effects for the patients health due to excessive 8 radiation?

9 MS. MERCHANT: Some of them were injured very 10 badly.

11 MEMBER NELP: How many would that be?

12 MS. MERCHANT: Actually, I didn't go through 13 them. On none of these that I am describing were 14 paperwork errors.

15 MEMBER NELP: I understand that.

16 MS. MERCHANT: But most of them were not 17 really badly injured I don't think. In most cases we 18 concluded in the data base, no adverse effects, no adverse 19 effects. Even in some little bit higher --

20 MEMBER NELP: Did anyone die because of 21 misadministration?

l 22 MR. CAMPER: Yes. One.

23 MS. MBRCHANT: One. And then we had at least l l

24 one additional, if not more, but one additional who when l 25 you start talking about the cost of misadministrations, I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

313 1 would be willing to but that the cost that was incurred 1

7-~x 2 because of his misadministration probably covered the cost .

3

.'N'/ 4 of' radiation safety for that whole modality for the whole year.

4 5 MR. CAMPER: There were cases of erythema.

1

6- There was one that I can recall erythema and some  !

l 7 ulcerations of the skin. There is of course the death. l l

8 But we have not called out how many patient injuries {

9 occurred within those numbers.

10 MS. MERCHANT: The one patient that comes to I l

11 my mind was one who had seeds administered to his '

i 12 prostate. The seeds turned out to be 10 times what they i

4 13 should have been. They weren't able to recover them. As a O ks _, 14 the year went out, we were hearing things like he had a 4

15 fistula, leaking urine. He was no longer able to walk l 16 because of injury to the spine.

l 17 MEMBER WAGNER: How did that occur?

l f 18 MS. MERCHANT: Apparently they -- I can tell  ;

1 j 19 you exactly. I was out on it. The seeds were ordered.

20 The radiation physicist did not measure the seeds when i 21 they came. When he saw that someone had written down that 22 they were in the 10 times more range, he at that point l 23 decided there must have been a mistake and corrected it, 24 gave the seeds to the doc. The doc. implanted them.

(os_-) 25 MR. CAMPER: I can add to that. What happened NEAL R. GROSS J

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

314 1 was th re wzo a verbnl order placed by a nuclear medicina 2 technologist. The seeds were received. They were off by 3 an order of magnitude. They were logged in with the 4 correct value, the assay. They were taken to the 5 implantation. It was only after the implantation that the 6 physicist actually looked at the receipt log which showed 7 the seeds at four millicuries or so, and realized that 8 wait a minute, could this really be. Then they began to 9 realize what had happened.

10 So you had a verbal order. Someone who was 11 receiving and logging in who didn't recognize the source 12 ' strength should be much lower. The no comparison of the 13 written directive says this, the strength we're about to 14 administer is this, let's go. That was done after the 15 fact.

16 MS. MERCHANT: He actually erased it before 17 the implantation. He actually erased what was written on 18 the log because he thought it was wrong.

19 MEMBER NELP: In that event, you go back to 20 the manufacturer and provider of the -- he's the one who 21 is I presume at error.

22 MS. MERCHANT: We don't know who erred. He 23 has a record that said that he sent what he sent.

24 MR. CAMPER: The position of the distributor 25 was that --

I NEAL R. GROSS l

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433 l I

4 315 l 1 MEMBER NELP: But ha didn't scnd, he didn't n 2 send what he said he sent.

3 MR. CAMPER: No, no, no, no, no.

4 MEMBER NELP: Oh the manufacturer did?

1 5 MS. MERCHANT: He sent what he said he sent.

J 6- MEMBER NELP: Okay. I'm sorry.

7 MR. CAMPER: We have no requirement that these d

4 8 orders be placed in right.

i

, 9 MEMBER NELP: I understand. I thought that

. 10 the error was --

4 1

, 11 MS. MERCHANT: So you know, but those are far 12 between, those horrible things that it's one error on top 13 of another error on top of another error that results in

( 14 something.

15 MEMBER WAGNER: The question that I would pose 16 is number one, there's a very low frequency of this kind >

1 17~ of occurrence, as tragic as it is, as much as we would l

18 like to eliminate it. So if you have got a very low 19 frequency of this kind of thing, it's a multiple error j 20 syndrome. All these tragedies are usually a multiple 21 error syndrome where everything just starts breaking down.

22 In looking at what you descried to me, there I 23 have to look back at the qualifications of the 24 individuals, because there are so many multiple things N

1 25 broken down. There's the issue.

J NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

316

, 1 Wh:t I would really want to quantion is l

2 whether or not, and I don't know that we can answer it, I l

3 would really the full implementation of OM rules across i

j 4 the board to everybody and all the burden it puts on 5 everybody, especially those who are doing a good job, 6- would it really have prevented something like this, where 7 you have all this kind of thing going on. That's the real l 8 issue. Is does all this ratcheting up, ratcheting up l

9 really make sense in terms of the minimal return on l

10 benefit. That's

• issue.

l 11 MS. ME. fANT: Lou, I need to say that, and l 12 I'm probably talking out of turn. I'm going to do it i

13 anyway. That won't be the staff's recommendation.

14 I think that what we are finding with this 9lll i

15 review is that people are doing a pretty good job out l 16 'there and we may have reached the level where it's a 1

17 diminishing rate of return.

18 So I mean take from my data -- I don't want to 19 convey the thought that we are saying, and we had these 20 terrible findings. We think the findings are -- you know, 21 people have -- yet they have implemented the rule. There 22 have been some incidents, yes. But I don't think that 23 they are real impressive. There have been some.

24 The impressive portions of it are that the few 25 people who didn't do a good job, didn' t do a good job. h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 W/.SHINGTON, D.C. 20005 3701 (202; 234 4433 I

317 1 MEMBER WILLIAMSON: I think ceveral of un j-~ 2 would appreciate if you could supply your best guesses

%- 3 what the denominators are.

4 I think the other issue is, when this error 5 rate is so low, I mean 10 to the minus four it looks like 6- for. And I know some of these because our paperwork 7 misadministration, I know that for a fact because 8 unfortunately our institution was implicated in two of 9 those 52. They are believe me, 100 MR to a patient's 10 thigh has no immediate consequence.

4 11 MR. CAMPER: Can I make a point?

12 MEMBER WILLIAMSON: Let me finish my point,  !

13 please. My point is that when the rate of even at sort of 4 p).

(, 14 technical errors is down at 10 to the minus four, perhaps

15 the rate of medically significant errors is perhaps almost 16 an order of magnitude lower. It becomes really difficult, 17 I think, to make a statistical determination whether --

18 what the effectiveness of this kind of a program is.

19 MR. CAMPER: The point I want to make is, 20 there's no such thing as a paperwork misadministration.

21 The misadministration is when there is a 20 percent error 22 in the dose which is delivered versus that which was 23 intended. That is the current threshold. There no such 24 thing as a paperwork misadministration.

1 (r"%i 25 l

e MEMBER WILLIAMSON: I beg to disagree. 1 V s NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE,, N.W.

l (202) 234 4433 WASHINGTON, D.C. 2000 53701 (202) 234 4 433 i

318 1 MR. CAMPER: You may d: bate the threshold on 2 whether -

3 MEMBER WILLIAMSON: The wrong site specifies 4 no threshold at all. You can give a microsievert to the 1

I l

5 wrong site, but have a misadministration. l l

6 MR. CAMPER: That is correct, but it's not a l

7 paperwork exercise. It's the wrong treatment site. You 8 can debate the thresholds, Jeffrey, but I'm just saying 9 there's no such thing as a pure paperwork 10 misadministration. That's a misnomer.

11 CHAIRMAN STITT: Well, we're going to time 12 out. Go to your corners, those of us who were involved in 13 this tend to view it that way.

14 Sally, do you have anything else you want to 15 say?

16 MS. MERCHANT: Only just very quickly. I hate 17 to use this slide, but Larry said I had to.

18 MR. CAMPER: Truth in lending.

19 MS. MERCHANT: Of the 138 events, at least 51 20 of them were real misadministrations. They all resulted 21 from licensee actions that resulted in this 22 administration. There were three severity level ones. .

1 23 There were four severity level two violations, and 36 24 severity level three violations. In addition, there were 25 eight severity level four violations. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOCE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

319 1 All 51 involved failure to mset either p 2 objective three or four. The largest number of them are

(

3 wrong information entered into the computer. Wedge 4 factors that weren't put in, just errors that resulted in 5 misadministrations to the patients. They were for the 6 most part threes, a lot of fours, that -- you know, we 7 have the reasons for the misadministrations in the data 8 base. There were a lot of errors, just errors. You 9 wonder why that many.

10 CHAIRMAN STITT: I think we should order out 11 for pizza because everybody wants to c.amment now. This 12 side of the table gets to have one, and that side gets to l

13 have one. i I

V) 14 MEMBER SWANSON: I am shocked that there 15 continues to be misadministration errors. I thought the i 16 quality management program was supposed to be put in place 17 to prevent them. What truly is the effectiveness of the 18 quality management program?

19 What's the incidence of misadministration 20 errors before the quality management program versus after 21 the quality management program? In fact, do you have any 22 data whatsoever to demonstrate that there's more errors in 23 those people that aren't doing a good job with their 24 program versus those people that are doing a good job with m

25 their program?

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

320 1 In othar words, what is the benafit of th2 2 program, not these individual data points.

3 MS. MERCHANT: What's the bottom line?

4 MEMBER SWANSON: And second point, what 5 information have you gleaned from this? Have you 6 discovered any trends or patterns to prevent 7 misadministrations down the line?

8 MS. MERCHANT: Some interesting things tht' 9 have come out of it is, and I don't have the number, I can 10 provide the number. You would be surprised how many 11 people don't do any kind of acceptance testing on new or 12 repaired computers. I would have thought that was 13 something that absolutely everybody did without being told i 14 to do it, that it's just a normal part of -- I mean, my i

15 background is nuclear medicine. We would not buy a camera 16 and not make sure the thing -- we would no more think 17 about doing that than fly.

18 Yet, there are people there who are in doing 19 therapeutic work who do not do any kind. We don't tell 20 them what it has to be. I mean it can be anything you 21 think is a good way to acceptance test it. We have a 22 number of people who say no, they don't have a procedure.

23 They do not acceptance test their computer.

24 I mean I think that's an interesting thing.

25 The bottom line, no, the number of misadministrations have NEAL R. GROSS COURT REPORTERS AND TRANSCRiflERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

321 1 not changtd.

2 I will tell you this. The kinds of

's N'

/

3 misadministrations have changed, because when the 4 definition changed, now we're seeing a lot of brachy 5 therapy, teletherapy, for just the reasons that Jeff is 6- pointing out. A lot of incidents where the source has 7 come out and maybe laid against the patient's leg. We 8 never had those reported before.

9 So has it changed? Yes. The number really 10 has changed. But if you want to compare number to number, 11 the numbers are the same.

12 However, once we go through and do what Larry 13 described earlier and say an underdose, for instance, we O(_,/ 14 wouldn't even really -- why should we hear about an 15 underdose? But I'm saying that's part of the things that 16 are being reported right now because we have definitions 17 in place. If it's not within 20 percent above or below, 18 you have to report it.

19 So at this point in time, it appears that they 20 are the same if you only look at the number. If you look i

21 at what is being reported, they are down.

22 MR. CAMPER: The only exception to that is, is l 23 the strontium-90 applicator.

24 CHAIRMAN STITT: Wnich we're not going to talk O

\

Nm./

)' 25 about.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200053701 (202) 234 4433

322 1 MR. CAMPER: Which wa're not going to talk 2 about. But that's the only exception to the numbers which 3 have not changed. That one has changed rather 4 significantly recently.

5 CHAIRMAN STITT: And clinically, as an 6- oncologist, I am far more interested in an under dose than 7 a small dose to the thigh, which was a site you didn't 8 wish to give to, but that comes into practice of medicine.

9 We can't discuss that here.

10 MEMBER FLYNN: The number of brachy therapy 11 cases per year is probably in the range of 50,000. So in 12 a four-year period, 200,000 would be the denominator, as a 13 very rough estimate.

14 The severe accident which involved the iodine j 15 seed implants off by an order of magif*ude, I think also 16 it's good to look at root cause or stee j oint where that l 17 could have been caught with what I would call a trip wire.

18 A trip wire kind of effect.

19 Now right now, I believe there is only one 20 vendor who supplies the iodine-125 seeds for prostrate 21 seed implants. I think ther l'robably supply stronger seed 22 strengths occasionally for other implants, but there are 23 approximately 5,000 being done per year now, and it's 24 growing rapidly.

25 Now when they get a phone call, I think it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVEL, N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

- . = . _. --

323 1 would be reasonable for them to screen with a trip wire, H

-~ 2 saying what is the order for.

j If it's for a prostrate i <

i

\--

3 seed implant, I don't think anyone in the country is using 4 seed strengths greater than .5 or .6.

5 MEMBER WILLIAMSON: That was questioned. The 1

6- vendor, in personal conversation with me claims that they 7 were ordered. Basically their screening was overruled.

8 They said yes, this is what we want.

9 MEMBER FLYNN: No. I think with 5,000 orders i l

1 10 a year, I am willing to bet that maybe only two or three  !

\

11 orders would come up. So that someone in a knowledgeable l 12 position would have to check with someone in a 13 knowledgeable position at the other institution, because im

__ 14 with 5,000 orders the next year, and the following, in a 15 couple years it will be 10,000 orders a year. So there i

16 would be quite a few prostate seed implants with iodine- l i

17 125. I 18 I think this one rare event where the order is 19 off by an order of magnitude, somebody has to call the 20 physician, the physicist, you know, the RSO and someone at 21 a very high level at the Amersham company would have to be 22 involved to overrule an order like that, not someone 23 sitting at a screen who was hired at minimum wage.

24 MS. MERCHANT: Actually, in that particular (D

(

V) 25 case, there was a root cause. The root cause, you won't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE 'SLAND AVE. N.W.

(202) 234-4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

324 1 like to h cr, wna tha failure to have a QMP.

2 What happened is, it was a large facility, 3 university, broad scope, wonderful place, wonderful 4 program. I can't say enough good things about the place.

5 They were doing procedures at a little hospital in the 6 next town. Although they did wonderful things at their 7 own place, when they got to the little place, all that's 8 off.

9 They didn't measure seeds. You know, all 10 those wonderful procedures that got checked and double 11 checked at their own facility, they did not bother to take 12 with them when they went to the little OR. Neither of 13 them had put any kind of a program in place for the small 14 facility where this happened. It was just a matter of I 15 guess you would call it like moonlighting. They just 16 didn't feel they had to comply with the same things that 17 they complied with back home.

18 MEMBER FLYNN: But that is at the tail end.

19 I'm saying you can solve the problem at the source. You 20 can probably, I should say you probably will solve the 21 problem at the source of the supply.

22 The supply is coming from one vendor. I mean 23 it's so easy for them to ask what it's for. If it's for 24 prostate, there should be a red light that goes off if 25 they order anything more than a certain strength. A trip h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000 53701 (202) 234-4433

325 1 wire.

, ,, 2 CHAIRMAN STITT: Do you have a comment, Naomi?

\N/ i 3 DR. ALAZRAKI: Yes. I wanted to following up l

4 a little bit on what Dennis was driving at, have you l 5 looked at and if so, is there any relationship whatsoever 6 in these to training levels of the individuals involved?

7 MS. MERCHANT

Occasionally there is because 4

8 tied in with the quality management of 10 CFR 35.32 and l

9 35.33, at the time the rule went into effect, there was an  ;

4 10 insertion in 35.25, which is the supervision, which is 4

11 really the training requirement.

l 12 In other words, it requires there that

13 individuals be trained in the quality mana ecant w program.

, ~~

(, 14 That is stretched wide enough to say, for instance, that

{ 15 nurses have to be trained to care for the patients. If 16 they are not, then it's a failure to supervise. If a 17 technologist does the procedure and doesn't know what' they 18 are doing, then it's a physician's failure to make sure 19 that when they delegated the responsibility or the task, 20 they can't delegate the responsibility. When they 21 delegated the task, that they didn't ensure that the 22 person that they delegated to knew what they were doing.

23 So there are vialations of 35.25 in there.

24 That would be the way it's differentiated out. Yes, there 25 are violations.

(O)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON D.C. 20005 3701 (202) 236 4433

326 I 1 MR. CAMPER: Right. Not in the training of l 2 the physicians.

l 3 DR. ALAZRAKI: In the other personnel. I mean 4 the technologists certainly.

5 MR. CAMPER: Yes.

6- MS. MERCHANT: And in fact, with the nuclear 7 medicine studies, the therapy, most often the error I 8 observed most often, and I don't have numbers, is the --

9 I'll say it. It's the same old same old, where somebody 10 somewhere orders a whole body scan on a patient instead of 11 an uptake, and the patient ends up getting a therapeutic 12 dose instead of an uptake because the tech somehow -- it's 13 all done verbally with nothing in writing.

14 The tech knows under QM not to dose the 15 patient without something in writing if it's above 30 16 microcuries, but they go right ahead and do it, and don't P

17 even ask the magic question do you have a thyroid.

18 So that's the most often one that happens.

19 That patients that are coming for diagnostic procedures 20 end up getting a whole body, diagnostic whole body. It's all done with no paperwork having happened.

21 22 If you could only get the message across that 23 you can't do this unless your doctor tells you to do !.t, 24 and that's usually a supervision error that the tech can 25 do that.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4432 l

327 1 CHAIRMAN STITT: Any other comments for Sally?

2 MEMBER NELP: I move that we' adjourn.

/ 3 CHAIRMAN STITT: All right. Business is a

4 concluded for the day. The crowd is looking not even 5 restless. We'll convene at 8

00 tomorrow morning. We are 6 making some adjustments in the schedule. So we'll finish i

7 at the same time. But we'will have time to revisit the 8 issues that we left off with today with our tabled motion.

9 Eight o' clock tomorrow morning.

10 (Whereupon, at 5:24 p.m. the proceedings were I

11 adjourned, to resume at 8:00 a.m. the following day.)

12 i

13 T

i G 14 i

/ 15 16 17

)

+ 18 l

i 19 20 3

21

22 5

23 24

25 i

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVEL, N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

1 4

1 i

!(

CERTIFICATE i

{ This is to certify that the attached I

proceedings before the United States Nuclear i

! Regulatory Commission in the matter of:

i i

i l Name of Proceeding: ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES (ACMUI) j 4

Docket Number: .N/A j Place of Proceeding: ROCKVILLE, MARYIAND i

were held as herein appears, and that this is the original l

9

transcript thereof for the file of the United States Nuclear I

l 1

Regulatory Commission taken by me and, thereafter reduced to i

j typewriting by me or under the direction of the court l-i reporting company, and that the transcript is a true and l

accurate record of the foregoing proceedings.

i n/d "CORBETT RIWER b

j Official Reporter l Neal R. Gross and Co., Inc.

,t i

i a

i l

I. NEAL R. GROSS cous neromns AND TMSCnWWW l taas PHODE 18UWe AVEMK, NW j (ace) ass 44ss WAsHseTON D.C. 20006 (203) 2S44433 1 .

1 i o DISCLAIMER V

This is an' unofficial transcript of a meeting of the Advisory Committee of the Medical Uses of Isotopes, of the United States Nuclear Regulatory Commission, held on November 14-15, 1996, at the U.S. Nuclear Regulatory Commission, Two White Flint North. Washington, D.C. 20555. All but one 4

session was open to the public. One session of the meeting was closed to the

] public to prevent invasion of personal privacy of committee members.

t This transcript has not been reviewed, corrected or edited, and it may contain i inaccuracies.

p The transcript is intended solely for general informational purposes.

As provided by 10 CFR 9.103, it is not part of the formal or. informal record l

of decision of the matters discussed. Expressions of opinion in this

transcript do not necessarily reflect. final determination or beliefs. No i pleading or other paper may be filed with the Commission in any proceeding as

! the result of, or addressed to any statement or argument contained herein.

i j except as the Commission may authorize.

4 m

4

O O Ow

[ .hf

. uSTRATEGIC ASSESSMENT

,}&

Larry W. Camper, M.B.A., M.S., Chief Medical, Academic, and Commercial Use Safety Branch Advisory Committee on the Medical Uses of Isotopes November 14-15,1996 ~

O O O l

~

l l TION SETTING ISSUE PAPER #7:

ERIALS/ MEDICAL OVERSIGHT .

W 5

• OPTION 1: Increase regulatory responsibility with addition of x-ray, accelerators, and naturally-occurring and accelerator-

produced radioactive materials l

• OPTION 2: Continue ongoing program, with

! improvements l

49 s eg, a 5.i

, 1 6

'i CTION SETTING ISSUE PAPER #7:

ERIALS/ MEDICAL OVERSIGHT .:

? .:

• [.,

l

• OPT . Decrease oversight of low-risk activities with continued emphasis on high-risk activities

• OPTION 4: Discontinue regulation of all medical activities except for oversight of devices and manufactures (NAS recommendations)

• OPTION 5: Discontinue materials program 2

O  ?

0 0 O l CbMMISSION'S PRELIMINARY VIEWS

=.; ,

• Com 6n of Option 2 and Option 3

.1 l't 7 A. i Co ddb ongoing program with improvements Decrease oversight of low-risk activities with continued emphasis of high-risk activities Utilize risk-informed performance-based approach Determine low-risk activities

-i*.

3

i COMMI.SSION'S PRELIMINARY VIEWS (continued)

A,Aff: I

~

• It with ACMUI

.9. . .  ;

guidance on low-risk medical activities revision to 10 CFR Part 35 guidance on implementation methods

• Evaluate feasibility of using professional organizations develop professional standards and guidance 4 '

_ _. _ _ _ _ - __I

O O O DIRECTION SETTING ISSUE PAPER #12 i RISK-INFORMED, PERFORMANCE-BASED REGULATION

• OPT Continue current process AUb118htion determined by balancing external and internal goals and available resources Apply priority criteria (Appendix A of DSI #12;l i

relationship of the activity or proposed activity to the agency's commitment to good regulation safety impact, burden reduction, efficiency 5

x

f 4

DIRECTION SETTING ISSUE PAPER #12 i RISK-INFQRMED, PERFORMANCE-BASED REGULATION m  ;

(continu ,

y

• Sco fectivities determined by consideration of 4

industry demand safety benefit i ease of implementation available resources i

• OPTION 2: Assess relationship to public health and safety .

l -

application determined by cost of initiative compared to the benefit to the public health .and safety 6

l O O O j

l O O O l DIRECTION SETTING ISSUE PAPER #12 '

RISK-INEORMED, PERFORMANCE-BASED REGULATION v

y:,

d"$

~

• OPTl . .

ontinued)

' critena weighted toward greatest safety benefit cost vs. benefit overall impact on NRC and regulated industry available resources

• OPTION 3: Perform comprehensive assessment of

NRC regulatory approaches I

maximize internal self-assessment ,

7

d

DIRECTION SETTING ISSUE PAPER #12 RISK-IN ED, PERFORMANCE-BASED REGULATION

! ~

• OP, (continued)

Qt ca rdvidhv regulations and regulatory processes areas to determine areas that can be improved with a risk-informed, performance-based regulation

• OPTION 4: Consider primarily in response to stakeholder initiatives determined by stakeholder demand and ease of implementation

= p t.

8 9 9 9 ,

L o o o

.ls ,

41%.. ,.x ION SETTING ISSUE PAPER #12 ,

RISK-IN ED, PERFORMANCE-BASED REGULATION i  :' ..

.. ,y  ;

• OPTION 4 (continued?

priority weighted toward industry initiatives to use risk-informed, performance-based approaches to reduce regulatory burdens i I

9 i

J

DIRECTION SETTING ISSUE PAPER #12 RISK-IN, ED, PERFORMANCE-BASED REGULATION

.a COMMI .e PRELIMINARY VIEWS

! A$

• Highd isif activities should be primary focus of efforts and resources j

• Level of efforts of lower risk activities determined based on:

impacts on safety

- i stakeholder initiatives burden reduction effect on agency and licensee efficiency

l l

10 O O O .

\

o o o DIRECTION SETTING ISSUE PAPER #1.2 RISK-IN -

D, PERFORMANCE-BASED REGULATION

, ,1 COMMIS PRELIMINARY VIEWS (continued)

.i

• Continue with current process, Option 1, in cooperation with the industry, including pilot programs

• Staff should proceed in enhancing PRA implementation plan (Option 3) focused assessment of regulations which can be risk / performance based 11 y

TlON SETTING ISSUE PAPER #12 I RISK-1 . D, PERFORMANCE-BASED REGULATIOgl

, ~..

Q COMMI PRELIMINARY VIEWS (continued)

• Consider cumulative impacts:

safety stakeholder initiesives and burden reduction effect on NRC and licensee efficiency 12 O O O ,

O O O DIRECTION SETTING ISSUE PAPER #12 RISK-INEORMED, PERFORMANCE-BASED REGULATION COMMI PREL1MINARY VIEWS (continued) i

'f?i$

• Consider cumulative impacts (continued):

Evaluate and clarify any technical and/or administrative issues associated with performance-based approaches to regulation, such as:

inspection activities i

enforcement l 13 1

l 3

i DIRECTION SETTING ISSUE PAPER #12 RISK-INFORMED, PERFORMANCE-BASED REGULATION li$

COMMIS,

~

. , . PRELIMINARY VIEWS (continued)

^33

-):j ,' vRfa.f..

• Consider 60mulative impacts (continued;i:

perform a thorough review of the basis for regulations and process identify areas that are now, or can be made with minimal additional effort / resources, amendable to

a risk-informed, performance-based approach

!

• NRC solicits comments on how NRC should deal with duel regulation when applying this regulatory philosophy 14 l 9 9 9 +

O O O NA .

AL ACADEMY OF SCIENCES STUDY 2

MAJOR G  ; x

'D . ..

• ExamiAatidd of the overall risk associated with the use of icmzing radiation in medicine

• Examination of the broad policy issues that underlie the-regulation of the medical uses of radioisotopes

• Critical assessment of the current framework for the regulation of the medical uses of byproduct material l

1 a

N L ACADEMY OF SCIENCES STUDY

• NRC SOUGHT RECOMMENDATIONS ON:

• Uniform national approach to the regulation of ionizing

. radiation in all medical applications i

i

• Appropriate criteria for measuring the effectiveness of the regulatory program (s;! needed to protect public health and  !

safety l

i

. . e. . .

____ _ _ - _ _ _ _ _ _ _ _ _ _ _ - - - _ _ - _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ - _ _ _ - _ _ - _ _ _ _ _ _ _ b:-

0 0 0 M RECOMMENDATION A1:

The' committee recommends that Congress eliminate all aspects of the NRC's Medical Use Program,10 CFR Part 35, and those regulatory activities conducted under 10 CFR Part 20 that are applicable to medical uses.

i t

i 3

1

IOM RECOMMENDATION A2: -

Congress digctthe Secretary of Health and Human Services to support, coordinate, and encourage the following activities involving regulation of all ionizing radiation in medicine:

a. supporting the operation of the CRCPD;

b. providing a venue for the review and evaluation of Suggested State Regulations for Control of Radiation;

c. assisting states in implementation of their regulations;

d. aiding in assessment of the effectiveness of state programs through the collection and analysis of data; O O O 4,

O O O ECOMMENDATION A2 (cont'd): N

.. I

4 M$Y .hi. 1

e. helping develop survey methods by which the rate of adverse events for a wide range of procedures and devices might be measured;

f. monitoring the effects of deregulation;

g. enhancing training and standards for health care personnel; and

h. investigating future significant radiation medicine incidents.

5 .:

+

i l

v ** e ..:j,_ , .

IOM RECOMMENDATION B1:

The NRC immediately relax enforcement of 10 CFR 35.32 and 35.33 through its present mechanisms

$ $ $6 j m

O O O l

e

" i 3d M RECOMMENDATION B2:

The committee recommends that the NRC initiate formal steps under the Administrative Procedure Act to revoke Part 35 in its entirety, if Congress fails to act within two years in response '

to the two recommendations to Congress stated above.

t 7 at

.,; ."1?

.5 .x M 1,  : &

" "b 10M RECOMMENDATION B3:

The committee recommends that the NRC separate the costs of formulating regulations from the cost of administering those regulations. li i

e i

e e r

e8 j

o o o

. . I 3

.w

,9E M RECOMMENDATION C1:

The committee recommends that the Conference of Radiation Contro! Program Directors incorporate into its Suggested State Regulations for Control of Radiation any relevant concepts from 10 CFR Part 35 that are not already integrated in those suggested regulations.

9 o

l

>. m .. .,

e# r

'"' A OM RECOMMENDATION C2:

i The committee recommends that all state legislatures enact enabling legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs. l i

i

• * *? 4;

O O O M RECOMMENDATION C3: -

m

,q x-k :j.

.g The commi @fecommends that the Conference of Radiation Control Program Directors and the states continually reevaluate their regulations and procedures pertaining to radiation medicine to ensure congruence with evolving scientific understanding of radiation bioeffects and to be in accord with advances in knowledge regarding benefits and risks related to medical and biomedical research uses of ionizing radiation in medicine.

1

11 l at

.._._Aa p.a,sa_a4.,-ae- .-4-r-m- - ----+d_ ac4-ex-en,.e.r--a-.a awas men. -e, as% a--e4mw-,h2,4,-e.3_.M4ew- d --een ama

. M ads #t -.4W A aJwear.Ah 46 4= mi,.M 4 #, A-.s A M .4 %-.w-4.m.---hm .a,Je a4_ w a s eq.u k, i

l 4

e a

O f

4 1

J, l

l i'

I l

l 4

1 4

4 J

l l

4 d

}

i ii 4

l a

a

! 1 1

e 01 1

i f

4 e

I i

a 4

e t

e J

i 4

a 1

l 1 0

-O O O ACMUI RECOMMENDATIONS '

FEBRUARY 21-22,1996

. i p

l

• Alterq'.,

~  ;

Substantive Federal oversight Mechanism to insure compliance of the states and users, such as linkage to Medicare reimbursement l

Recognizes problem with uniformity of state regulatory programs

--- 1

.d\

l ACMUI RECOMMENDATIONS (continued) .

ACTIONS FOR REGULATORY REFORM w.

e RebB~ . medical use r

~

use current Part 35

'ss the objectives of the regulations l

• Federally mandate states to administer medical use l l regulatory program l

Incentives to-encourage states to comply

• State programs monitored by a Federal agency  ;

i Federal agency should be an agency with overall medical perspective - Department of Health and Human Services 2

O - _-

O

O O O x

-m

m. .o, 't RECOMMENDATIONS (continued)

, f,TI NS FOR REGULATORY REFORM

• Encompass all uses of ionizing radiation in medicine

• Conduct the medical use regulatory program uniformly, whether by Federal agency or by the states t

3 .

.t

~l

O O O ISSUES FOR ACMUI

• Wh MUI's reaction to DSI #7 and #12? #N s -

• AC .

k.. . ,,.hil assist NRC in:

l' responding to the Commission directives given in DSI #7 and #12 developing the regulatory philosophy and framework for regulation of medical uses developing language to revise Part 35 for an anticipated Advance Notice of Proposed Rulemaking 1 .

.S ;

ISSUES FOR ACMUI

• AC ill assist NRC in (continued):

. f; ^

1 ,

(th

.< > t

' wing the existing Part 35 and identify

" areas that should be maintained and those areas that should be eliminated or modified reviewing issues previously identified by the l staff for consideration in Part 35 revision, e.g.

brachytherapy issues, HDR, and Regulatory j Guide 10.8 modules 1

l develop plan to assist in interfacing with the stakeholders, such as professional  !

organizations

. - . . ~ . . - , sau + . . - . s.ss .-, s . . - . . .-_.. - a ..,.-...+,-..,-..~..-a n- 2. - .... ..

4 l 0A l C) V Organization of Agreement States l

l

- Robert Quillin, Chair. Roland Fletcher, Chair-Elect Richard A. Ratliff, P.E., Past Chair I Thomas Hill, Secretary i

! November 7,1996 l

1 i

i j Torre Taylor l U.S. Nuclear Regulatory Commission j Office of Nuclear Material Safety and Safeguards

~

Washington, DC 20555

Dear Ms. Taylor:

Enclosed for your consideration are the comments of the Orgamzation of Agreement States on Strategic Assessment Issue Papers-DSI 7

Materials / Medical Oversight and DSI 12: Risk-Informed,

, Performance-Based Regulation mee ly,

! / --

l Robert M. Quillin, Chair Orgamzation of Agreement States

Enclosures:

as stated cf: Dr. Judith Stitt j OAS Executive Committee

j -

l i/- .

Organization of Agreement States

!I >

Comments on U.S. NRC Strategic Assessment and Rebaselining Initiative Direction Settine Icme Paper #7

" Materials / Medical Oversight The Orgaruzation ofAgreement States (OAS) supports the concept of a consistent and unified national program for the regulation of all sources of ionizing radiation. It makes little sense to continue to divide radiation programs according to archaic historical distinctions . However NRC's Strategic Assessment and Rebaselining Initiative Stakeholder Involvement Proces falls short in addressing all radiation safety issues and doesn't provide a complete perspectiv this issue. Little mention is made that the majority of radiation exposure is from non-AEA' sources and thus gives the impression that only minor changes to NRC's program are needed.

Further, it appears to provide questionable information to support its own conclusions. For example, the statement that it would take "several hundred" FTE's to regulate discrete NARM is highly doubtful. NRC should work closely with the Agreement States on this important issue as they have greater regulatory responsibility and collectively regulate about 70% of AEA material and almost 100% of all sources of human radiation exposure.

OAS supports efforts to identify regulations that are unnecessarily burdensome, duplicative or too prescriptive. This is especially needed for Part 35 regulations. The option of using a risk-based approach is supported by most states however such criteria must be uniformly applied to both existing and proposed regulations. ' Identification and classification of " low-risk" activities must be done in conjunction with Agreement States. The NRC must not abandon regulatory control over " low-risk" activities solely to reduce its regulatory burden. Such an action could result in additional problems faced by all radiation control programs such as the problem of poorly controlled generally licensed devices.

Since Agreement States have broader regulatory authority and experience with regulating all sources of radiation, it is strongly suggested that th,. NRC consult with the Agreement States prior to finalizing its position on this issue. The following are individual comments on DSI -7.

W

,_,_ ,, , ,2.

e i

k' _ _

i {Vy- ' Organization of Agreement States y

Comments on

1 9 U.S. NRC Strategic Assessment and Rebaselining Initiative

1

! Direction Settina Icma Paner #7

" Materials / Medical Oversight i

1 The Organization of Agreement States (OAS) supports the concept of a consistent and unifie

[ national program for the regulation of all sources of ionizing radiation. It makes little sense to i

j continue to divide radiation programs according to archaic historical distinctions . However

! NRC's Strategic Assessment and Rebaselining Initiative Stakeholder Involvement P falls short in addressing all radiation safety issues and doesn't provide a complete persp

{ this issue. Little mention is made that the majority of radiation exposure is from non-AEA sources and thus gives the impression that only minor changes to NRC's program are needed.

} Further, it appears to provide questionable information to support its own conclusions. For example, the statement that it would take "several hundred" FTE's to regulate discrete NARM is

]

highly doubtful. NRC should work closely with the Agreement States on this important issue a they have greater regulatory responsibility and collectively regulate about 70% of AEA material i~ and almost 100% of all sources of human radiation exposure.

i OAS supports efforts to identify regulations that are unnecessarily burdensome, duplicative or ;

prescriptive. This is especially needed for part 35 regulations. The option of using a risk-based 1 i

i approach is supported by most states however such criteria must be uniformly applied to both existing and proposed regulations. Identification and classification of " low-risk" activities must l j  ;

be done in conjunction with Agreement States. The NRC must not abandon regulatory control over " low-risk" activities solely to reduce its regulatory burden. Such an action could result in )

I additional problems faced by all radiation control programs such as the problem of poorly controlled generally licensed devices.

i Since Agreement States have broader regulatory authority and experience with regulating all sources of radiation, it is strongly suggested that the NRC consult with the Agreement States prior to finalizing its position on this issue. The following are individual corenents on DSI -7.

1

'I l

l 0 -

l Colorado 1.

A valid option that should be considered is to increase regulatory responsibility with the  ;

addition of NARM. The proposed Option 1 (assume control over NARM and x-ray) is I too broad a mission change, while increasing with just NARM requires no new skills of staff, eliminates duel regulation at hoepitals, moves toward fulfilling a request the states have often made - that NRC oversee WARM 2.

In response to the question of NRC striving to encourage more states to become Agreement States, see comments under DSI 4.

l 3.

Page 11 states an item to be considered is the interpretation the Commission has adopted l that medical patients are included in the "public" This DSI neither discusses the issue i further nor asks for comments from the public. Our opinion is that patients be protected through the regulatory framework. State representatives at the Agreement State meeting in Vancouver, Washington also reached this conclusion. This opinion should be continued unless there is strong arguments from many groups against it.

4.

Page 15 states it would take several hundred FTE's to promulgate discrete NARM regulations appears excessive. Since NARM is similar to AEA materials, incorporation l should be more procedure than divergence into new frontiers.

O Illinois The Direction Setting Issue (DSI) "What should be the future role and scope of the NRC's Nuclear Materials Program, and in particular, NRC's regulation of the medical use of nuclear material?"

Although this DSI purports to address all material oversight, the vast majority of the paper focuses only on the medical area. The Department is in support of the NRC's initiatives to streamline the licensing process, eliminate duplicative or contradictory regulations, and update regulatory guidance for all categories of lic,ensees, not just medical licensees. However, we would caution the NRC not to abandon the regulation of radioactive material altogether. The use of radioactive material in this country is safe for workers because there are established requirements for users of radioactive materials. The public is protected because of the regulatory community's diligence in ensuring that individuals using radioactive material do so safely. In some cases, it is necessary to modify the regulations to be less prescriptive, but it is not necessary to relinquish all controls over the safe use of radioactive material. In fact, it is appropriate for the NRC to consider expanding its regulatory

?

p authority to establish uniform safety standards for all forms of ionizing radiation.

O Specific Comments Option 1 As indicated on Page 15 of DSI 7, Agreement States are in support of establishing one federal agency to work with the states to establish basic standards f all uses of radioactive material. We recognize that this is a major departure from NRC's current approach, however, we believe it makes sense to treat all ionizi radiation equally. A rem to an individual is still a rem, whether it comes from Co-60 Ra-226 or an accelerator.

Although this report states that it would be difficult to support legislation to address all sources of ionizing radiation "in the absence of a compelling safety i

problem," we find that argument to be short-sighted. As indicated throughout this DSI

(and DSI 2 and DSI 4), many state regulatory agencies already have established programs to address all uses of ionizine

' 'iation in their respective states. States did not wait for an incident to develop a p: am, but have been pro-active in ensuring the safety of workers and the public. In fact, it may be that the states are in a better O position to oversee certain DOE operations because the state programs are more

encompassing.

f The report's estimate of several hundred FTE's to regulate discrete NARIG possessed by persons in non-Agreement States and by federal agencies is outrageous and without any foundation. The NRC need only ask the Agreement States about the i

marginal impact of regulating discrete NARM sources in their states. An elementary l

assessment of the "several hundred" statement would mean that the effort to be applied to discrete NARM is vastly larger than the resources now devoted to agreement  ;

a materials. That is incredulous. The NRC does not need to go down this path alone.

States with experience in regulating NARM are willing to share their expertise and

(

experience. i 4

Option 2 1

' As stated above, we support the NRC's efforts to identify regulations that are obsolete, unnecessarily burdensome, duplicative or too prescriptive and the NRC's work to modify or delete these regulations. We also support the NRC's efforts to l

streamline the licensing process. The modifications made to-date through the BPR should benefit up to one third of the NRC's licensees (measuring system licensees).

i.

, We agree that this option should continue to be pursued.

l l

Option 3 We strongly urge the Commission to reconsider its support of Option 3. A joint NRC-Agreement State Working Group on devices recently reported that problems associated with the NRC's general license program included inadequate regulatory oversight, inadequate control and accountability of devices, and improper disposal of devices. The working group developed strawman solutions and recommendations aimed at regaining control of the use of both generally-licensed and specifically-licensed devices. These recommendations included requirements for users, distributors and regulatory agencies. Option 3 of this DSI, however, recommends minimal regulatory oversight, minimal licensing requirements, and the possible elimination of inspections.

As written, it appears that Option 3 is advocating regulation of only "high-risk" activities. We agree that some streamlining commensurate with risk is warranted, however, we are firmly opposed to abandoning requirements for all " low-risk" i activities. The regulations supposedly are written to minimize risk to workers and the public. Proper training and use of radioactive material will result in lowering any risks I associated with using radioactive material. If you remove the regulations designed to limit the risk, you can no longer ensure that a " low-risk" activity will remain such. l Opuon 4 The NRC should not discontinue the regulation of all medical activities, just as it  ;

should not discontinue the regulation of all other uses of radioactive materials. It is vital that the NRC recognize the professional views of the Agreement States, physicians, physicists, pharmacists, hospitals and professional organizations regarding the unnecessarily burdensome, detailed and prescriptive requirements of Part 35, and make modifications. To assist in determining the proper course of action, the NRC, j FDA and representatives from applicable boards of medicine and pharmacy should l

jointly develop a paper describing the jurisdictional boundaries of each entity relative to regulating the use of radioactive material and the practice of medicine. Such a document would be a great reference point to begin recalibration of the applicability of existing regulations.

We would like to point out that there are numerous references to a " consensus" of Agreement States on the IOM recommendations at the technical workshop held March 5-6,1996 (see pp.21, 25 and pp.17,24,25,26, and 29 of the Attachment).

The NRC has been cautioned that the March workshop was primarily a meeting of technical state staff and not policy makers or program directors. This has been a

. problem with other NRC sponsored meetings. While we do not think Agreement State l

I 1

i policy makers would substantially disagree with the workshop attendees, a better

( reflection of ALL state views is contained in the position passed by the CRCPD on May 8,1996.

Based upon discussion topics from DSI 2, the Department of Veterans' Affairs j

may need to reconsider its position that legislative initiatives should ensure that federal

)

facilities are not subject to state and local regulations (Page 21, Paragraph 2). Under some circumstances, it may be appropriate for states to regulate federal facilities, and l we oppose self regulation of medical uses by federal facilities.

Option 5 As indicated in our comments on Option 3, the NRC must not simply discontinue its oversight of the use of radioactive material. It is unreasonable to assume that individual states and federal agencies would self-regulate to the same degree. This could cause problems for facilities doing business across state borders.

Deregulation of radioactive material sends the message that the material is inherently safe, a sentiment that Congress is unlikely to agree with.

Section V. Commission's Preliminary Views We agree with the Commission's preliminary views regarding Option 2, and caution the Commissior. to consider possible problems encountered with deregulation of ~

" low-risk" uses of radioactive material. Time and resources would be better investe and a greater number of citizens would benefit if the NRC would spend more time visiting and inspecting facilities, rather than spending those resources imposing civil 1 penalties, which seems to have become a routine practice.

We do not believe there should be encouragement for non-Agreement States to develop programs to regulate only medical use. This effort to segregate medical uses from a comprehensive radiation safety regulatory program raises questions about unequal treatment of medical licensees as compared to other licensees, such as m,casuring systems licensees. For additional comments on this issue, please refer to the CRCPD position dated May 8,1996, on the NAS-IOM study.

Other Comments Page 10, Paragraph 4 Although this section has no specific guidance, any effort to ameliorate the full O cost recovery ti roblem should not be linked to Agreement States, present or future.

l NRC must look to other mechanisms to solve that problem.

New York State Department Of Labor O\l 1

In keeping with our comments on Direction Setting Issue 4 (NRC's Relationship with i Agreement States), we strongly recommend adoption of Option 5, tuming over all regulato l authority for Atomic Energy Act (AEA) materials to the states, which could be preceded by Option 3 during a transition period.

1 Option 5 is in accordance with the recommendations of the NRC National Performance  :

Review Steering Committee, and in accordance with the National Academy of Sciences Institute of Medicine recommendauns for NRC's medical regulation program.

We would also emphasize again (as in our comments on DSI 4), the economics of the situation. Options 5 is the only reasonable hope that NRC licensees have to contain or reduce their fees, since the other options would make only trivial differences. Eliminating 50% of NRC's remaining licensees, for example, would only eliminate 50 staff positions according to this paper. However, there is no estimate of the effect that this would have on fees for the remaining 50% -- perhaps they would increase due to the smaller licensee base.

We also note that this paper expresses a concern that mrning over all regulatory authority for AEA materials to the states could be considered an "Unfunded Mandate," and viewed as subject to the Unfunded Mandate legislation. this is presented as an argument  :

against Option 5. Strangely enough, concem over unfunded mandates didn't enter into the discussion in DSI 4 of the Commission's possible recommendation that ABRA-90 be modified so the NRC could charge Agreement States to recover its " oversight" costs 1

So on the one had, it is argued that states should not be burdened by the unfunded mandate of the NRC's turning its materials program over to them, while on the other hand, Agreement Stated, which have voluntarily accepted an unfunded mandate, will only be considered co-regulators and equals if they paid part of the expenses of the federal agency whose work they have taken over! l

)

Two strong themes mnning throughout many of the NRC " Direction Setting Issue" papers are its shnnking licensee base and money. The themes are inexorably linked since NRC is required to recover all operating costs from licensees. As the number of licensees declines, fees rise and this accelerates the decline by causing licensees to give up their licenses or even relocate to Agreement States. This should be seen as a natural process driven by Section 274 of the Atomic Energy Act, which created the Agreement States program. The more successful the Agreement States program is (i.e., the more states that accept responsibility for " Agreement" materials and add them to their radiological health programs),

the more marginal NRC's program becomes and the more difficult to support. Since states now regulate 70% of " Agreement" materials licensees, and will soon regulated 80%, it is

. __ . . . _ _ _ _ _ _ _._ _ .._._ _ _.__ _ _ __m . . ~

i t

rapidly becoming impossible for NRC to suppon its program by fees imposed on such a small

, number of licensees. I

{

i There are ways in which NRC could reduce its operating costs, such as eliminating its l

I costly and extensive practice of contracting out work that cold be done by its own technical '

i staff, and reducing its research and rulemaking activities to those that are truly necessary to protect health and safety.

) They could also save substantial amounts by adopting rules already developed by L

j Agreement States (such as Industrial Radiography and Well Logging regulations) and adoptingi

cost-effective practices already used by Agreement States to expedite licensing and inspection activities. Instead, NRC chose to discontinue the training it formerly offered to Agreement

States, at a trivial savings of one-half million to one million dollars a year.

l >

However, although such cost containment actions should certainly be undertaken as mtenm measures, they are not the solution. The solution is for NRC to recognize that what is i j

happening is the desired outcome for the Agreement States program: the successful transfer of regulatory responsibility for Atomic Energy Act Section 274 materials from NRC to the states.

, i Having achieved that goal, there should be no question that Section 274(a)(6) of the ACT must '

i  ;

now be implemented. That provision states that "as the states improve their capabilities to j i regulated effectively such materials, addition legislation may be desirable." this legislation l l

would properly be t amend the AEA to withdraw the federal preemption of AEA material, and '

j restore them to the universerse of radiation sources already regulated by the states.

i I Unfortunately as in the DSI 4 paper, the Commission's preliminary views are basically to maintain the status quo with some decreased oversight over" low-rick" activities. Asi9 i

from the arguments we have already made against that amounts to a "no-action" option, this j

begs the question of who will pay for NRC's program if they insist on continuing it. there is no question our minds that the state will not.

1 e

In regard to NRC's proposal to decrease oversight of " low-risk" activities we have the following comments:

While the wording used in regard to defining " low-risk" is vague, we hope j (and strongly recommend) that this will involve a risk-based reevaluation of all existing j i

, generally licensed and exempted radioactive materials in NRC regulations. The results l of such a global reevaluation should be used to redefine and restructure these 3

i j

' regulations, not just to move currently defined generally licensed and exempted material from one category to another.

i we strongly recommend that this reevaluation include elimination of the general t

license given in 10 CRF Part 31, section 31.5. and reallocation of these devices to exempt or specific license status.

i

) -

'Ihe proposal to transfer some current specific licenses to general licenses 1

i

appears to be an attempt at an ill-considered " quick fix" to reduce NRC's work oad.

We have submitted comments to NRC elsewhere (July 29,1996 letter fro'n 2R:

Aldrich to Carl Paperiello) on the problems inherent in " general" license: which have '

resulted in accidents requiring millions of dollars to be spent in remediation. Our letter suggested more innovative ways of shifting resources to reduce burdens on both regulatory agencies and regulated parties.

1 Also, even though this proposal is planned to reduce 50% of NRC's current specific licensees to general license status, with a drastic reduction in oversight of these j

programs, only 50 NRC staff are expected to be climinated as a result. We believe '

strongly that this proposal would result in a significantly increased risk to health, safety and property while producing negligible savings.

NRC should begin an immediate review of all of its regulations for AEA materials, with the objective of eliminating as many prescriptive requirements as possible. For example, although every licensee needs to implement a radiation protection program, the existing requirement to perform an annual audit of the program, and of the conduct of the radiation safety officer, is reasonable only for larger, more sophisticated programs. However. NRC's guidance for portable gauge licensees (one of the categories it now apparently wants to relegate to general license status) contains a four and a half page form to be used for such audits. this combination of a needless regulatory requirement, made even more onerous through

" guidance" is not unusual. therefore, instead of seeking quick and easy fixes that may degrade the current level of safety, NRC should perform a thoughtful review of it regulation -- Part 35 in particular -- and its guidance documents for the expressed purpose of reducing regulatc 'y burdens on itself and its licensees.

This regulatory reevaluation should be conducted concurrently with the implementation of Option 2 under DSI 4. since simplifying regulations, and making them performance-based and easier to implement, should in itself attract states to Agreement State status. the reevaluation should of course be conducted in close consultation with the Agreement States as NRC also works on implementation of Option 5.

Tennessee our review indicates that we favor a combination ofOption 2 (Continue the Ongoing Program with improvements) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis on High-Risk Activities). This is consistent with the change in regulatory oversight as new methodologies with low-risk have become more widely used over the history of medical regulation. We believe that the U.S. Nuclear Regulatory Commission should modify and enhance its program to regulate all radioactive materials, and, although we would reserve the right to comment further, we believe that the U.S. Nuclear Regulatory Commission should seriously consider regulating all radiation sources. '

. I i

i j

Tenesee's general assessment of the NRC's Strategic Assessment ofRegulatory Activiti

,' k the effon appears to be constrained so that ony select options are presented. In many ,

options are analyzed or presented in a manner that does not allow a fair, unbiased assess one option versus other options. One particular example is the statement under DSI 7, IV.

OPTIONS, Option 1, Impacts, which notes:

i "Such wide . sweeping legislation may be diffcult to support in the absence ofa compelling safetyproblem. "

This statement is made to denigrate the safety problems that exist in the non-AEA radiation E source arena'(machine source, and NORM). This is wry interesting in light of the daea that i

demonstrates that most exposure to ionizing radiation occurs in the radiation machine arena 3.

that 50% or more of that is unnecessary. Similarly, the states find numerous situation

! NORM problems that expose the public to unnecessary radiation exposure well beyond the at 'which Atomic Energy Act (AEA) materials are regulated.

1 l.

j Thus the referenced statement would actually be more appropriately applied to the qu need for continuing the current AEA legislation in light of the safety problems that are not i

addressed by the AEA. Why do we regulate AEA materials to the point of decreasing return l

, while ignoring the larger safety issues in machine produced radiation and NORM?

h i

It was Tennesee's impression that this effort by the NRC was to start from zero to assess what it should be doing. The information presented actually appears to be developed to justify the continuation of the NRC activities as currently constituted. It is clearly not an unbiased full i

assessment of what radiation protection at the federal level should be. It is clearly not even an 3( unbiased full assessment of what radioactive material radiation protection at the federal level should be.

1 In several DSI's the concept of state involvement is toyed with, but full assessment is never j

'significantly considered in the specific options. For example, in each instance in which an op

considers the NRC take on non-AEA sources great pains are made to elaborate on the nece resources that this would require when all that may be required is recognitin of the resources that j

are in existence in the states. NRC need only become the senior partner in the operation, ass

consistency and compatibility among the programs.

Tennessee proposes onc simple option for the regulatin of all radioactive material.

, i i

i Texas As stated in the Texas response to the recommendations of the National: Academy of Science,

! we suppon the concept of one federal agency for all sources of radiation. This combined with a commitment of that agency to risk-based regulations and programs, would ensure greater i consistency of regulation of those sources.

1 i

Options 2 and 3-to improve the regulation of radioactive material and decrease regulation of j /T sources that do not present a significant risk-should be implemented immediately and would j i be the options of choice if legislation to achieve Option 1 is not feasible. For example, all gas

+.

i'

C chromatography sources could probably be generally licensed. Medical regulation needs to be rethought, especially diagnostic nuclear medicine.

Option 4 could be disastrous, since it would create yet another orphan use that is regulated differently than any other use of radioactive material. Option 5 trught eventually be desirable, but could create an unfunded mandate for states, if the programs were simply handed over to the states.

We agree with the Commission's proposed choices. However, considerable consultation with the Agreement States must be utilized. Significant risk exists that either (1) funher fragmentation of radiation safety regulation will occur; or (2) the NRC will continue to mandate regulatory requirements that have no health and safety basis. The important conclusion one should draw from the IOM report is not that medical radiation should be de-regulated, but that NRC implementation of prescriptive regulations was inappropriate and heavy-handed.

It was not clear how the NRC envisions the "related issues" to be purely a Commission issue as long as NRC controls Agreement State compatibility and adequacy detriinations. In addition. it would seem strange not to consider input from licensees on these issues. This comment pertains to other DSIs.

It was noted in the issue paper on page 14 that the definition of discrete NARM included radium sources and wastes from cyclotrons, but left out important NARM sources in the medical arena, those being radiopharmaceuticals used for positron emission tomopgraphy.

5.

The Commission's preliminary view may be appropriate. It is appropriate to apply a risk-informed performance based approach to the oversight of all regulated activities.

However, the DSI does not provide enough discussion on the impact to the public, patients, licensees or public health and sdety.

Washington I suppon a combination of Options #1 and #3: ALL uses of radiation regardless of source (Option #1) should be regulated according to their relative risk of harm to humans (Option

1. 3). We should have a consistent, uniform, national program for the regulation of ionizing radiation which necessarily includes NORM, NARM and x-ray as well as by-product material.

It rnakes little sense to continue dividing the issue to radiation safety according to archaic historical distinctions. Whether the issue is " misadministration", generic machine defects, computer programming errors, or radioactivity in the environment, the regulatory requirements should be based on the health risk and apply equally to any source of radiation:

NORM, NARM, by-product material, or machine produced radiation.

There should be a decrease in the oversight of " low-risk" activities while refining and emphasizing control over "high-risk" activities. However, this does not mean that " low-risk" activities can be automatically dropped to the current. poorly regulated " general license" i

f 4

O _Agreement status. States The appropriate and the CRCDP.level of regulatory oversight should be determined in co Option 2 is not supportable since it infers that the current degree of oversight requires "

little" modification. The fractiousness among that " improvements to increase efficiency" wi be satisfactory. " Revision of regulations to make them more risk-informed and performance-based rather than prescriptive" is much more appropriate but should be done in the context of Option 3 which takes a broader look at all regulated activities of NRC.

Options 4 and 5 are not supponable because they represent a particular abrogation of federal responsibility which would lead to increasing fragmentation and disparity among isolated state radiation control programs across the nation. This would not provide consistent, unifonn radiation protection for citizens as they move from one jurisdiction to another.

1 V

i 1

V i

.. j '

4 1

p .

Organization of Agreement States f

1. Comments on I r

h

U.S. NRC Strategic Assessment and Rebaselining Initiative l i Directinn Rettina Icene Paner # 12

! " .i i

Risk-Informed, Performance-Based Regulation" Sunanary The Direction Setting Issue (DSI)- "What criteria should the NRC use in expanding the sco applying a risk-informed, performance-based approach to rulemaking, licensing, inspection an enforcement?"

i We support a combination of certain aspects of all the options. Promulgation of regulations  ;

should be primarily as described in Option 1 because consideration of industry demand, safe benefit, ease of implementation, and available resources should always be considered in rulemakmg. As described in Option 2, even when considering the items mentioned in Option 1, overall protection to public health and safety should be given the highest priority. In addition, cost / benefit of any rulemaking should also be one of the primary considerations, overridden'on '

O by protection of public health and safety. There are aspects of Option 2, notably to pursue concurrence with EPA on risk bases and models and assumptions to be used, that would be l

beneficial. Option 3, to perform a comprehensive assessment of NRC regulatory approaches, is a desirable goal and would go a long way in achieving regulatory coherence and consistency. As .

described in OptiorA, ibe NRC should always be open input from the stakeholders. Licensee data concerning risk analysis, cost-benefit analysis, licensee need, and the licensee's ability to maintain an acceptable level of safety with innovative approaches must always be considered.

Discussion In response to the first focus question as to whether imponant considerations may have been omitted from the issue paper, several important concerns were not addressed in the direction setting issue on risk-informed, performance-based regulation with regard to materials regulation.

In coordination with the CRCPD, the NRC has agreed to participation in a parallel rulemaing process with the Agreemer.t States, in which a panicipatory involvement among all involved parties is emphasized. No mention is made of this type of cooperative effort for the materials Program.

The NRC describes the bases for rules and standards issued by the NRC. The issue paper describes the' Atomic Energy Act, Congress and the Executive BrancP standards-setting orgamzations such as the ICRP, NCRP, and National Academy of Sciences, fe&d agencies, the nuclear industry, and the public. Conspicuously omitted are the CRCPD and the Agreement

' States. CRCPD, through its committee work and resolutions is a srmraard setting orgamzation.

~ The Agreement States have established standards through regulations that the NRC has used as

l l

a model for its own regulations, specifically well-logging and industrial radiography rules.

In the discussion of risk-informed, performance-based regulation promulgation, the NRC aga pointedly fails to acknowledge or discuss the impact of compatibility determinations by the NRC on regulations it promulgates. Agreement States often have distinct directives to consider in promulgating rules. including those NRC mies designated as compatibility items. These directives include emphasis on reducing regulatory burdens and that, in many instances, means deleting revising existing rules if they do not have a direct effect on public health or safety. Most '

Agreement States must complete a cost / benefit analysis for any rule it introduces. The parameters for such an analysis are specified in both law and agency procedure. If the parameters and assumptions used by the NRC in completing a cost / benefit analysis for a compatibility regtilation are different than those used by an Agreement State, titis creates a significant conflict.

Throughout the issue paper. NRC references a probabilistic risk analysis to be used as a means for prioritizing regulatory activities. The risk analysis would consider cumulative impacts on safety, burden reduction, and efficiency. To consider these parameters, assumptions must be made and the risk "modeled." The assumptions made by NRC may not be applicable to specific Agreement State simations and by designating a rule an item of compatibility, the Agreement State is in effect forced to accept assumptions that are not applicable. An example of differing risk is the regulation of naturally occurring radioactive material (NORM). The predominant sources of '

NORM, concentrations of NORM, prevalence of NORM in the environment and workolace, industries that generate NORM and are thereby effected by NORM regulation, and risk to the general public vary greatly from state to state arx! region to region. Risk assumptions made about NORM in the phosphogypsum industry in Florida differ significantly from risk assumptions made about NORM in the oil and gas industry in Texas. Although the NRC does not have the authority  ;

to regulate NORM. the concept of differing risk applies to the regulation of other radioactive <

materials.

As a performance goal dose limit standards have worked fairly well, suffering only from a lack of understanding by the public of the meaning of dose limits. In a transition to a risk-informed performance-based (RIPB) approach, risk information should begin with an explanation to the public that the dose limits have always included safety margins which keep risk as low as reasonably achievable. It may be that the real incentive for using a risk-based approach is an attempt to put exposure / dose information in a form which can be more readily understood by the public. The changes to the RIPB approach should be accompanied by and aggressive public education program.

An RIPB regulatory approach would necessarily be based on probabilistic calculations. Such calculations are usually accompanied by an uncertainty analysis. Problems can arise in uncertainty analyses when choosing input distributions which may, under very low probability circumstances, cause the output distributions to include the dose limit. It would be better to use as much site- or process-specific information as possible in a deterministic bounding calculation to show that compliance performance is achievable.

As with risk analyses, cost / benefit analyses must incorporate certain parameters and assumptions

i ie

} that may be significantly different from state to state. Again, designating a rule an item o .

compatibility may force a state to either utilize inapplicable assumptions or not adopt an

' compatibility because an applicable cost / benefit analysis may notjustify adoption of the j Specific Comments l Option 1-Continue Current Process 1

Some aspects of this option are more amenable to the regulation of radioactive material ,

{

flexibility to balance internal and external goals with available resources is necess

}

government agency. This must be tempered with the need for additional radiation standards to i- address emerging problems and new technologies.

Option 2-More Rigorously Assess Relationship to Public Health and Safety

! Because the NRC is tasked with providing adequate protection for the health and sa i

the public. it makes sense that they should focus on those areas that constitute the most risk to public. It seems logical that the regulator would seek the best tools available to accomplis j task. If risk assessments can be relied on to identify the risk contributors, they should be used in the regulatory process where it makes sense to do so.

'fs l 4\

If risk assessments can not be relied on, then more conventional means, or some combination of analyses, will have to be used. Inherent in risk analyses are uncertainties caused l

by lack of objective data. The better the data, the more assurance we have that risks can be

[ predicted. Data can be resource intensive to gather. Hence there is a cost / safety benefit tradeoff As the NRC did not require rigorous PRAs as part of the IPE process, and there is no other i [

e requirement to perform one, risk assessments vary in quality across the family of plants. This i

makes consistent applicanon of them (regulatory coherence) difficult. In addition, use of generic data undermines the plant specific desirability of risk analyses. If the priority is the " greatest i

safety benefit"; and there is a potential for " substantial benefit and increases in overall public j-protection"; and it comes down to a safety / cost tradeoff for both the NRC and the regulated industry; and there is a safety goal policy in place to help determine the safety benefit side of the i equation, how can it be argued that a rigorous safety analysis capable of measuring that benefit, or at least in understanding the uncertainties in the analyses, is not desirable, and that available

' resources should be a constraint?

l The NRC applied resources and strongly encouraged licensees to adopt the standard l MM specifications for their design plant, to make the licensing functions more senmiard and i

less costly. Following the same line of reasoning, the NRC should follow a similar process in

} negotiating a satisfactory rigor for PRAs for plants. The NRC mat ~1 to define adequate i

protection (how safe is safe enough) of the beakh and safety of the public in the safety goal policy.

We believe that rigorous PRAs should be required of power plant licensees, so they can be relied i

on as satisfactory tools to be used in the applications for which they are useful in satisfying that safety goal policy. Ideally, this would be done by a rulemaking. We believe that plant specific risk analyses should be required should meet standards for accuracy and completeness, and should be kept current.

Option 3--Perform a Comprehensive Assessment of NRC Regulatory Approaches Once the results of Option 2 are determined, Option 3 could be applied to verify and bound the rigor that needs to be applied to the risk analyses to ensure the safety goal policy is being met and safety / cost tradeoffs are thoughtful and consistent. Prioritization of rulemaking activities. exemption'of insignificant risk materiais and uses, and application of limited resources t

to areas of higher risk would remit from this approach.

As stated in the discussion of this issue with regard to the nuclear materials area, such a framework could be developed in which a systematic assessment of mies and regulations would result in identification of areas that are amenable to a RIPB approach. We encourage NRC to pursue the resolution of issues associated with dual regulation. This causes delays and additional fmstration ih establishing and implementing standards.

Agreement States can be and should be a panner in implementing such an approach. These regulatory programs regulate a majority of the materials licenses. Their experience in reviewing sources, developing licensing approaches, and implementing decommissioning standards should be utilized. Other stakeholders, such as industry groups and professional societies have des eloped initiatives that could be taken into account.

Option 4-tonsider Risk-Informed. Performance-Based Approaches Primarily in Response to Stakeholder Initiatives To give stakeholders a say in how they are regulated in a cost-conscious deregulated environment is desirable. A caution is not to abdicate regulatory responsibility to the stakeholders, or appear to put them in the position of self-regulators, when cost versus safety issues clash. There is good reason in both the regulatory and competitive environment for licensees to have a rigorous safety analysis to justify cost savings.

Subsumed Issues

1. What should be NRC's strategy and philosophy with respect to changing NRC's responsibilities and authority ina reas oflittle public risk?

If the area falls inside the safety goal policy, regulate it. If it falls outside the safety goal policy, it is outside the NRC's adequate protection legislative junsdiction.

(

" -2 What approach should NRC take in modifying the materials regulations to move toward risk-l

' informed. performance-based regulation, recognizing the requirements will vary as a result of the range of products and the divergence of the licensees that use or possess byproduct nuclear material?

As described in the summary and discussion of the options above.

3. Should-NRC revise its regulations to addmss the use.of materials resulting from technologic advances and changing human factors? If so, to what extent should NRC aniculate objectives to :

prevent or limit the effects of equipment failures and human factors / human performance?  !

i Yes, the degree of risk and need for and type of regulation is dependent on the qualifications of '

the users (human factors) and the inherent safety of the material or device being used. Any additional regulations in these areas must be firmly justified by documentation of safety problems.

For example, the requirement for certification of industrial radiographers was backed by documentation from NRC and Agreement States that assuring that individual radiographers were qualified to use the potentially hazardous sources decreased significantly the potential for incidents -

and overexposures. Likewise, development of certain inherently safe source / device combinations could and should result in their being exempted.

i

4. What should be the approach for licensing material uses with various levels of inherent risks?

{

- The work of the joint Agreement State-NRC working group addressing the issue of generally licensed gauges has identified inconsistencies in terms of how cenain sources and devices are regulated. Input from this group will be important to identifying a reasonable approach for licensing. = Generally licensed gauge users ~should be either registered or have some mechanism i

for irderaction with or notification from the appropriate regulatory agency in order for the material to be accounted for and not inadvenently disposed of as scrap. Certain sources that are currently specifically licensed could be generally licensed or exempt, based on risk factors. Likewise, cenain multi-curie generally licensed devices should be specifically licensed. As discussed in subsumed issue 4 above, the approach must take into account human factors as well as technology.

I O

O

!I_

i MODALITY:

O 1. Who Licensed?

I i

i

2. echnicalIssues:

l (e.g., surveys, access controls) i i

i 1

i

! 3. Training and Experience:

i l0

4. Licensee Event Reports:

(Misadministrations, etc.)

1 i

i i

i l

i l 5. Quality Management:

i i

l 6. Records:

4 I

1 l 7. Organization / Internal QA:

l 4

f t

4

!f 1

i I

I i

! VIOBILE REMOTE e

l 1

}

i AFTERLOADING 4

i i

BRACHYTHERAPY 4

i l

l 8

l i

LICENSING MODULE J .

I 1

i i

i a

-l _ _ _ _ _ _

o O O Self-contained mobile HDR brachytherapy facility A mobile HDR treatment facility that provides ready -

to deliver mobile HDR treatment services on arrival at a client's site. The facility is entirely self- '

contained with a shielded patient treatment facility, HDR device, viewing, and intercom facilities.

1 i

t l

l t 6

,, ;._ x';\

/ -

0i 1

g_,

l \r v i p t f

. //

,. -1 4 ... . .

, ....-.  ; d. --

! ,=L.. ,.' 18 l

. . . a. c. , t

'~

/

e O

i 5 __ .. _ _ _ _ - --

o O O Transportable HDR device This is a typical HDR device that has been evaluated and found safe for use as a transportable or mobile l device. Patient treatments with this type of device requires prior installation of the device in an appropriately shielded 'and permanently located j

treatment room. Other support equipment, such as viewing systems, area monitors, and intercoms, must have been separately installed in the treatment room prior to use.

l This guidance: 9:

1 + Supplements existing guidance contained in draft Regulatory Guide 10.8 I t

Revision 2, or HDR licensing guidance contained in

Policy and Guidance Directive 86-4 (P&GD 86-4)

+ Specifically applies to the licensing of the 1

medical use of mobile high-dose-rate afterloading brachytherapy (HDR), as either,

. Fully self-contained mobile HDR therapy treatment systems, or Transportable devices relocated from

! one treatment site to another

!O i

! + Addresses both re.evant I

i Regulatory issue (s), and 3

l Health and safety issues 3

i 9

i

!O 1

i i

1 i

?

e 9

O

4 i

O Regulatory Issue i

4 i + 10 CFR 35.29(a) authorizes the licensingof l mobile nuclear medicine services in j accordance with subparts D, E and H of i Part 35 l + ALI mo 3ile therapy services are excluc.ed by l

10 CFR 35.29(a) i + Exemption required from 10 CFR O 35.29(a) for licensing of any mobile therapy service, as set forth by the folLowing standard license condition:

"Notwithstanding the requirements of 10 CFR 35.29(a), the licensee may use byproduct material for mobile HDR brachytherapy services as described in letter (s)/ application (s) dated "

O

Health and Safety Issues O i

+ Tais guidance is in adcition to existing i

guidance for the licensure ofRemote Afcerloading devices (RAL) and, thus, supplements the existing guidance

+. Specifical:y for mobile RAL applications, existing guidance is supplemented in the following areas:

Locations of Use O' Radioactive Material Facility Diagram Operational and Safety Checks Transportation O

Y

1 lO

i 4 LOCATIONS OF USE l

3 l

i l + A central (base) location for the mobile

! treatment faci:ity or transportable device j specified, anc. used for the following

! activities: l l

3 ic 4-Routine maintenance i

j . Byproduct material. deliveries i

Source exchanges activities J

i i

central records location

! i

i 4

i O

i

! + Information required for each temporary $.

c..ient site (app.ies to acta mobile anc.

transportable service c..ients)

Letter from client authorizing use of l byproduct material at the client's address l ofuse A signed agreement with an appropriate, nearby mecical facility to provide emergency care for any medical i

emergency that may arise whi:.e the j patient is undergoing treatment by the licensee l

1. Should include procedures for l handling emergencies arising from the inability to remove the HDR source from a patient i

O

i 5

jQ 2. If the app _icant can provide L

assurance that no treatment will be l l performed that could result in a source whica cannot be removed  !

l from the patient by the licensee, the l agreement then does not need to contain such provisions i

! + For transportabl.e mobile HDR treatment j services, the following additional

! information should be provided: l jO '

i .

For each site of use the applicant.should j provide the all of the information l l requested under " Facility Section" of the l guidance If the applicant will provide the radiation treatment to the patient, proof that e.ctablishes that the applicant has full control of the treatment room during its Period of use O

+ Ift:1e appi.icant is requesting aut:aorization 9

.imited to providing a transportab: e HDR device to clients, then the applicant should l provide a copy of each cL.ient's NRC or Agreement State license demonstrating the client is authorized to provide HDR treatments with the specific device provided by the applicant '

+ Tae initial instal: ation and function checks at eac a client site must be made by t:ae HDR O c.evice venc.or.

O

4 O

! RADIOACTIVE MATERIAL 4

+ For mobi

.e HDR app..ications only those i

sealed sources and/or devices specifically approved for mobile HDR 3racaytherapy

appi.ications are autaorized for suca use l Q + A radiation safety evaluation, specifically

~

authorizing that type of use, by either the l NRC or an Agreement State, as listed in i NRC's " Registry of Sealed Sources and i

Devices" is necessary for licensure of the device for mobile brachytherapy treatments O

i

1

. gl Facility Diagrams l

! Applicants for self-contained mobile HDR l

treatment system should provide the following j faci:Lity information:

\

+ Drawings wit:1 sufficient detail that conformance with the facility's sealed source and device radiation safety evaluation can be verified. (Presumes entire facility g

was evaluated as the de.vice)

+ A separate drawing should be provided for each client site showing the location of the treatment device / vehicle in relation to all nearby roads, sidewalks, structures, and any l other locations that could be occupied by members of the public. '

O

l

O l + The Location of t:ae device /venicle must be l on c_ient-owned or controlled i property covered by the .etter of agreement.

1 I

j + No vehicular traffic should be permitted in j the immediate area of the treatment facility j t:aat could potentially inflict damage to the facility or adversely affect patient treatment.

l i

'O

O\

Operational and Safety Checks (Following HDR Relocation)

Since the movement of the device from one l location to another increases the ris1 of e_ ecto /mec aanica component fai: Lures or misalignments, it is important that the proper operation of t:ae device 3e fully checkec after eac.a such relocation. Performance of the fo lowing procedures shou _d provide the necessary assurance that the device is operating g

properly prior to the commencement of patient treatments.

+ The applicant should submit a procecure establishing those radiation safety chec1s that will be conducted on the HDR device following any relocation of that unit, and

, prior to the beginning of patient therapy 9

\

i l

+ The i ensee should submit a radiation

!O j survey procedure intended to establish the j integrity of the radiation shielding after ech i relocation. This survey procedure should j inc_ude:

=

l A preliminary or baseline survey to j establish the normal exposure rates that include the source housing, with the source in the shielded position and all

! areas adjacent to the treatment room iO i

with the source in the " treatment" position Immediately following any relocation of the mobile device and prior to patient l treatment the licensee should conduct such surveys, as necessary ,with a l portable calibrated survey meter, to assure results comparable to the preliminary or baseline survey.

O

T l

O

! Transportation l (Vehicle Accident Procedures)

+ Transportation ofmobile HDR's must be conducted in accordance with Department of Transportation (DOT) regulations as l contained in 49 CFR Parts 170-189 4

+ T ae necessary DOT Type 7A package certification is established via prior approva of t

1e appropriate sea.ec. source and device g

saeets i + If the device is damaged in any way during use or transport, then the integrity of the DOT Type 7A packaging may be

. compromised and the device should not be used or transported until checked by the vendor and certified as retaining its integrity as a Type 7A package l 9

i

+

IO The licensee should submit a procedure that includes its emergency response regarc;ing i

an accident scenario. An accident is defined

{ as a vehicle collision or other events, such

) as, wind, water or fire damage that result in j damage to exterior or interior portions of the mobile van or device used in transportable j service.

i i

i

+ Any accident saould oe immediately

reported by telephone to the NRC

!O operations Center. The licensee should also j submit a written report within thirty (30) j days of the occurrence ~to the U.S. Nuclear i

Regulatory Commission, to include: l

! I t

A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned The exact location of the event

!O i

O T1e isotopes, quantities, anc. chemical and physical form of the licensed material involved Date and time of the event; Corrective actions taken or p .anned and the results of any evaluation or assessments; and The extent of the exposure ofindividuals O to radiation or to radioactive materia.s without identification ofindividuals ay name.

+ Following any accident, no licensed treatments should occur until all safety l systems pertaining to radiation safety, including interlocks and device operation in accordance with manufacturer specifications, have been tested and g

i iO c nfirmed to be operational by either the

! Medical Physicist or the Radiation Safety l Officer.

! + Al: licensee personnel involved with HDR

! transportation should receive biannual "hazmat" training in accordance with 49 i CFR Part 172.074.

+ A calibrated and operational survey meter l

should be maintained in the cab of the  !

!O transporting vehicle. Such a survey meter j may be used by the licensee at an accident l scene for conducting surveys to assure

! source shielding and integrity. ,

l l

l

!O i

j REVIEW OF LICENSE APPLICATION REPLY TO FIRST LIST OF i

DEFICIENCIES (Original Submission and Reply to First Region I Deficiency Letter Reviewed)

1. Reply to item 2.A.3. - Only provided listing of physician names and t

NRC license numbers. Do we need a copy of the license or other I documentary proof? -

l 4

j 2. Reply to item 2.A.4 - In their training commitments for their '

authorized physicist, no specific commitment is made to train using dry j runs for stuck or detached sources.

1

3. Reply to item 2.A.5 - Similarly no commitment for similar training gi 4

for their authorized users. W

4. Reply to item 2.A.10 - Calculations of maximum radiation levels i need more though review.

! 5. Reply to item 2.A.11 - Need to commit to providing specific licensee procedures in the procedures manual kept at the console. Not simply a copy of the device manual.

l 6. Reply to item 2.A.12 - Alternative procedures provided by the license appear to be satisfactory. Except the license needs to insure that l only one programing card is available during all patient treatments.

4

7. In discussing the device description submitted by the application

with the State of Maryland (Agreement State responsible for the applicable sealed source and device's radiation safety review) it was g discovered that the mobile HDR facility submitted by Mobile Technology W 1

4 f

I'8 MEQlCAL POLICY STATEMENT i 1 5

i

1. The NRC will continue to regulate the medical uses of l radioisotopes as necessary to provide for the radiation safety of j j workers and the general public. I i

d

2. The NRC will regulate the radiation safety of patients where

justified by the risk to patients and where voluntary standards, j or compliance with these standards, are inadequate.

I

3. The NRC will minimize intrusion into medical judgements l affecting patients and into other areas traditionally considered l to be a part of the practice of medicine, i 4 I l

i i

i l

}

d

\

o

! i 4

t l

1

)

i I-4 j

^~

l 8242 RUtts AND REGULAflONS

! p39,,,m .g) I. statuartsrT or OrmAr Pot.rer l generally oriented toward a.ssist::.g j

y;th M-. Energy This NRC polley statement is in. g$",*g P " re

,, t m tended to triform NRC licensees. Other 1

! ever, regulation by AEC. NRC his a' CHAPTER l-NUCLEAR REGULAfoty [y$3f,gfhe ont1Nion sen i ene time or another encompassed" l COMMISSION 1

tention regarding the regulation of nearly every aspect of the de! very of I the medical uses of radioisotopes. radiotsotope medical servlees to ca.

I PART 10-MUMAN USES OF It is expected that future NRC netiv, uents. The broadest regulation oc.

1 tyPRODUCT MATEtlALS ides in the medical area, such as pro- curred betseen 1962 and 1975 ater.

mulgation of new regulauens and de. the Food and Drug Admin:strauon Regulation .ef the Medical Uses of velopment of cooperative relationships (FDA) exempted from it.s rec ure.

j tedioisetepes: 5tatement of Gener- sith other Federal agencies, will ments for new drugs au follow this statement of NRC policy. radjopharmaceuticals regulated by i el Policy

, Based on past espertence and the AEC. During this period AEC regulab j comraents and advlos of the public. ed the radiation safety of workers and

AGENCY

Nuclear Regulatory Com- other Federsi agencies. the States, and the general public and the safety and mission.

1 NRC's Adytaory Committee on the e!!!cacy of radioactive drugs and de.

$ ACTION: Final Policy Statement. Ma itcal Uses of Isotopes the Conuals. vices with respect to pattents. AEC i

SUMMARY

The Nuclear Regulatory m.mt ,3, . has of developed the foUowing state. regulauon included production of tne i

Commission (NRC) has the following uladon o e to guide its rey. radioisotope, manufacture of the f:,nal uses of radioiso. radioscure drug product or device. dt...

policy statement regarding NRC's topes:'

8 I

future role in regulating the medical A 1. The NRC will continue to regulate tribution, use and disposal of the orod.

uses of radiotsotopes. This NRC po!!cy the medical uses of radioisotopes as ucts. I 1975, the FDA terminated the I statement is intended to inform NRC necessary to provide for the radlauon esempuon for radiopharmaceutsc.ts.

i licensees, other Federal and State salety of workers and the general stating that it would now regulate the I

agencies and the pubite of the Com. publ$ safety and efficacy of radioactive mission's general intention regarding# drugs with respect te patients. ( As l at on e op en w re "*

t ed 1o ts x ed ha tan ds, o co 1 *

future NRC scuviues in the med2 cal these standards, are inadectuate. .

area. such as promulgation of new res*

ulations and development of coopers. 2 3. The NRC will minimise intrusion regulating radioactive drug safety and efficacy, stating that it would regulate

tive relationships with other Federal into sr.edical judgments affecting pa*

cents and in;o other s'eas traditional

• the radiation safety of the workers agencies will fo!!ow this statement of ly considered to he a part of the prac. and the public. The 1976 MedJeal NRC poucy. tice of medicine. Device Amendments to the Food. Drug

EF7ECTIVE DATE

Fbbruary 9,1979. and Cosmetic Act extended FDA's au. -

II. R aygoyag,3 thority over medical devices (inch,dinc FOR FURTHER INFORMATION devices containing radioactive rnateri. )'

l CONTACT: The NRC and its predecessor the als) in a way similar to its authority Atomic Energy t'a==iestaa have regu. over druga.

Mr. Edward Podolsk. Office of lated the medical uses of radioisotope NRC's autt.arity to regulate comes.

i I standards Development. U.S. Nucle, since 1944. AEC recognised that physt. tically the n.edical uses of byproduct i

at Regulatory Commission. W&sh. clans have the primary responsibility matertal la found in the Atomic inston. D.C. 20555 (Phone: 301-443 for the protection of their pauents Energy Act of 1954. as amended. For 5460)- andThe designed its regulauens accort'ing.

to be easmale, section 81 of that Act autho-ly. physicians were required SUPPLEMENTAL INFORMATION: licensed by the State, and their appil. rises NRC "to issue general or specific The NRC has developed the fo!!owing cable training and expertence were Licenses to appucants seeking to use i

three part polley statement regarding evaluated in consultatlee with the Ad. byproduct material for * *

• medesi

! NRC's future role in regulating the visory Committee on the Medical Uses therapy * * *.** Section 81 directs NRC medical uses of radioisotopes. On of Isotopes. This msulation has bun to regutate the manufacture. produe. '

l March 17,19"aa, the three part poucy tion tansfer, receipt in interstate l i statement was published in the Press. comsnerce, sceuisition. ownership. pos.

i 'NRC lesenses reesetseteses in three case. session. Import and export of byprod.

As. Rtctstsa (43 FR 11204) for putue series: typreeuet. asures sad aseensa ausse. uct material. Finally. Section 81 sho 4

comment. Copies of the pouer state. er mateneL The N5tC does act regulate mat. directs that:

ment were sent to all NRC medical 18 ,8',*8"" '*y "The CeWm shati not permit the dts.

censees. the States and 38 profess 6enal "'*888 '""'"g"8 g,88"3"*' ,

societies. Federal meandas and indi. ,,,,, , ,,en gg,, aggen,: age,,g ,,

esas aussear materesas ywiese in er maee es.

tribuuen of ear typroeuct materut to any i

vidusta. The comment period emptred measuve er ======*e to the reestaan anos. orinsensee. and shall recata er order the recati w eastributes seaternaa trom any beens.

' May 18.1978. Twesuty two amm=.ata eset to the presses et presuetas or utinasing m, who is not eeutoped to obsem or taas to 1 sere recetted. Nine commenters fa. essetas awear matenat. Tks term msme **"sita N **h es may8*ktF Maneardsby be enablished to the amect Com.

wored all three parts of the poucy eneasnel means (18 uraneuse. thertism er any he statement. four commenters opposed -- taerset to any phyment e, sannesen er who uses such material m viola.

i one part of the policy statement and ehennassi feras er (s) eres enten asetasa by tien et law er eveulauen of the Commission

! weisht eme tweesleth et one poroset to.ess: la

• manner other than as disclosed in i nine commentes addressed specific er more' et (t) ureatum. (813 thertum er till) the spelleauen therefer er approved by the i

tssues discussed in the March 17.1Fft any commennuse therest. Sourse matenal C" ""*"

I Frosmas. Racistsa notice. The com. does not tashame esemal nuclear matenal. Commission regulations, for the menta are discussed in Section 11. Jewtel suelser meaened means (1) stutoes.

saast part set forth in 10 CFR Parts 30 I Cop 6es of the comments may be eatm. ,"se' " *'*

anr* through 35, were promulgated to carry ten the i

l Ined in the NRC Public Document Room at 1717 H Street N.W Wash. matenst artenenant ennched by any of the out the broad reguistory scheme em inston D.C. terseetns. but sees not lastues seuru mate. visaaed by section 81. For example.

naL Part 35 establishes regulations specific l

f PSDisat R$0eSTM. VOL. 44, tee. 39JR80aY, ptt4Uat? 9,19r9 0

I i

1

- - ~3 RULES AND MGULATIONS 8N to human uses of byproduct material. The NAS-BEIR s report discusses The regulations try to find a balance FDA's statutory authority (Federal !!miting the expostre of the popula- between adequate controls and asold Food. Drug and Cosmetic Act, as con to medical applications of lontr.tng amended. 31 U.S.C. 301 et sec.) does redisuon. That report, s'hich includes ance of undue interference in medica not diminish NRCs authority. Where all medical uses of ionizing radasuon. judgments. A consequence of NRC's and FDA's authorttles overlap. Shows an average dose rate from much regulation could be poorer the respective authorttles can be har. radiopharmaccuucals of 1 mrem / year health care delivery to patients. A con.

montzed by interagency agreement, and an average dose rate from daag. sequence of leaving to physlessns the The central question is a question of nostic radiology of 72 mrem / year in majortty of the doctsions concernmg policy not authority, namely- 1970, their patients is that the physician.s To snat extent should the protec. The following quotation la from the will make mistakes. The tightest regu-tion of the pattent be considered m NAS-BEIR report: lation of physicians' decisions by Fed.

NRC's regulauon of the medical use of baroduct material. in the formaseable futun. the aujor con.

tenutors to rediauon espesure of the popu n t be a e to p en fut r inc e From the standpoint of sufAcrtly, it lauen wiu conunue to be naturst naca'. in the mMeal uses of radiotsotopes.

Ls clear that NRC can regulate the swund with as aversee whole body dose of The Commission recognizes that medical uses of byproduct material to stout too sarema/ rear, and niedical applica. FDA regulates the manufacture and protect the health and safety of users uons which now sentribute comparatile es. Lnterstate distribution of drugs includ.

of this material, for instance, pauenta. pesures te earteus 14ssues of the body, breds. Ing those that are radioactive. FDA In licensing the posseaston and use of cal esposuns are not under control or ruso. also regulates the investigational and byproduct material. NRC establishes enes by reeulassee or law at oneent The research uses of drugs as teu as the

!!mits within which physicians exer. " 8 specific gujdance on doses and proce.

cise professional discretion. From the value it u standpoint of pohey. these limits reeuse espesures since this can be accom. dures found in the product labehng.

depend upon how NRC views the 90- ptished without lose. of benefit and at rela. However. FDA does not have the au.

unty now east. The aim te not only to thority to restrict the routine use of tential hazard to the patient's health reduce the redlauen espesure to the inds. drugs to procedures (described in the and safety in the uses of the byprod. vidual but mise to have procedures carned product labelinal FDA has approved uct hazardmaterial. The greater to a patient from the the potential byprod. canout with te a masunum comunuineefficiency incnase so that there as safe and e!!ective. Indeed. NRC ts in medical uct maternal or Ita use by a physician, beneftta aaaaaaa==w by a rauumum radl* the only Federal Agency that is cur.

the more NEC may elect to circum. suon espesurs rendy suWortsad to regulate me rn.

scribe areas that might otherwise be une use of radecuve drugs from the NRC will act to he!p ensure that rs> standpoint of reducing unnecessary ra.

regarded the physician. as within the discretion of dlauon exposure to pauents is as low diation esposure to patients.

as is reasonably achievable, consistent The first part of NRCs polley state. sith competent medical care and with The Commission believes that the ment indicates that NRC will continue miMmal intrusion into medical judg* diagnostic use of rsdioactive druss ts, to regulate the medical uses of radiot. ment NRC till not esercise regula* la most cases. clearly an area of low sotopes as necessary to provide for the tory control in those areas where. radlauon risk to pauenta. Therefore, rsdisuon safety of workers and the upon careful esamination, it deter

• NRC will not control physician's pre.

general public.8 This is the tradiuonal mines that there are adequate regula. Fogauves on pallent selectaon, instru.

regulatory function of NRC for s!! uons by other Federal or state sgen. mest selen, procedure mlecuen. l uses of byproduct. scurce and special clas or well administered professional drug se!ection and dose level for most nuclear material It is a regulatory standards. Wherevor possible. NRC diagnesue uses of radioisotopes. For role that was not questioned by any of will wort closely with Feders! and all therapeuuc uses of radioscure the commenters but, rather. it was State agencies and professional groups dNs. and in certain diagnosue h, consistently rarW as a necessary in designing new voluntary guidance for example, the use of pbosphorus.3.

role in the medical uses of radioiso. for practiuoners to limit unnecessary for localizauen of eye turnorsae topes. pauent redisuon exposure. risk to pauents is not low. The rtsa of NRCs regulation of the radlauen The third part of NRCs policy state. Ussw or organ damage (or even death:

1 safety of workers and the generst ment Indicates tnat NRC will mini, is inher=nt in the .tse of therspeuue public in the medical uses of radiolso, raise its intrusion into medical judg. levels of radioacuve drugs. NRC wt3 topes is relltmulahed by NRC to Agree. ments affecting the pauent and into continue to restrict the uses of thers.

1

• ment Stata1; does riot overlap with other areas tradiuonally considered to peuuc and certain diagnostic radioac.

FDNs acti itles; la in hannony with he a part of the practice of medicine. tive drugs to the indicated procedures

' regulauon by the Department of The Conuatssion recognises that phy. that have been approved by FDA. The Trsnsporutton. Social Security Ag. s6cians have the prisaary responsibflity NRC s111 not control the physicians' mtntstration and the Joint Commis, for the omtection of their patients. prerossuees on patient selection and sion on Accreditation of !!ascitals; and The Comuntasion believes that basse instrument selection for therapy pro- l dovetails with Occupallonal Safety doetslens eeneeretr.g the diagnosis and .cedures, because these procedures are '

and Health Administration regulation treatment of d.sease s ? a part of the so specialised and pauent specific.

I of the wort place for the use of natu, phys 6 clan patient relatiorchip and am Congress recently gave FDA authon.

rally-occurring and accelerator-pro, traditionally considered to be a part of ty to regulate medical devices, similar duced radioactive matertals. the practice of -W= 4RC mgula.

The second part of NRCs polley Lions am pudicated on the assumpuon to FDA's authority to regulate drugs.

statement indicates that NRC will reg. that property trained and adequately but with addiuonal authertty to re.

ulate the radlauon safety of patients informed physicians wQ make decb strict the routine use of medical de.

where justified by the risk to pauents La the best LMenst W tW W vlees as may be necessary to provide I"'

reasonable nasurance of their sa.fety and where voluntary standards. or and effecuveness. FDA has not yet compliance with these standards. are had sufficient une to implement its inadequate. As noted before. NRC has 'Nauenal Acadesey of Se'enees Aedsery full authority to regulate medical de-t the authority to regulate the tsdiation Committee se the BeeW E!!sna of le"* vices containing byproduct, source or j- safety of patients. raang ma% Nm nport. yhe F#eeds en Popstattena of Krpersre to Low special nuclear material. Therefore, 1

Unis of tenanne Aedtatten. Net:enal NRC will conunue to restrict physt.

"the tenn eenerti put>tte in this state. Acedene af Setende8-Neftonal Aeseeren clan's unse of these meda,,,g gences.

$ ment ssectricaltr eactuces pauenta. Coe ndl.1Fashins%ea. D.C. s t s72L both for diagnosis and therspy. to

}

n.natu vm.u.s n n.av. minere. = .,

i

)

s ,

i i 8244 RULt$ AND ttGULATIONS i those procedures that NRC has det:r. T ro commenters objected to NRC's As noted in the proposed poney l 1 mined tin consultation with its Adytso. regulation of patient radiation safety statement. NRC is studying the var. I

' ry Committee on the Medical Uses of because they believe that NRC does tous allied health certtitcation pro.

Isotopesi to be safe and effective. not have the autho'ity r to regulate ca. grams currently in effect or eeing i The Commission does not consider uent safety. They note that NRC's en. drafted by other Federal. State and equipment calibration, qualifications abling legislation does not specifically p'ofessional groups. If the cosersge i sf paramedical personnel or reporting mention the radiation safety of pa. provided by these programs is not ade.

l to NRC misadministrations of radione. tients. They beljeve that patient quate to brotect the patient from un.

j tise material to be exclusively the safety is the responsibi!!ty of the phy. necessary radiation exposure, NRC i

practice of medicme or a part of physt* sician a responsibility that cannot be will work with these groups to develco cian. patient relationships. The Com. shared. They believe that the Commis. a new NRC proposed rule for the

missten intends to regulate these areas sion is in error to equate patients with training of allied health personnel, j of patient radiation safety where justl* the public and to consider patients as There were five comments on the j fled by the risk to patients and where users rather than recipients of radio, specific subject of nuclear pharmactes

voluntary standards, or comp!!ance active material. (radiopharmacies).

{

m ath these standards are inadequate. As noted in the analysis of the simi. One commenter urged NRC to dts.

!!!. Disecsstow or Pustre CowwtwTs lar comment above. the NRC's overrid. tinguish between radiopharmacists ing congressional mandate is to pro. worlLing in a hospital setttng and those

4. cowworTs on fxg rotscy starmorr tect the health and safety of the working in a retail environment tcom.

I One commenter opposed the use of public. The patient is a member of the mercial nuclear pharmacy). This com.

I the general term " radioisotopes" in public, notwithstanding the Commis, menter also noted the complexity of i the first part of the polley statement. sion's recognition of physicians' prima, the problem of definition when the I This commenter was concerned that. ry responsibility for protection of hospital based radiophannacy pro.

! if taken out of the context of the foct. their patients. The policy statement vides radiopharmaceutleals to other note it could be interpreted to include and. Indeed, a!! of the Commission's hospitals and practitioners in its area.

naturally occurring and accelerator actions in regulating the medical uses As noted in the proposed policy produced radioisotopes. of radioisotopes. acitnowledge the sec. statement, the NRC will defer to the The Commission believes that the ondary but necessary role of NRC in Food and Drug Administration (FDA) general term " radioisotopes" is plain regulating the radlauon safety of ps. regarding a determination of those ac.

English and easily recernized by the tients. The Commission also considers tivities of nuclear pharmacies that silt public. It was properly footnoted in patients to be both users and recipl. be considered manufti:ture and those the policy statement to include the ents of radioactive material. However. activities that will be considered the more cumbenome but specific terms' the distinction.between receipt and ordinary practlee of pharmacy (com.

byproduct, source and special nuclear use of red;oactive mat!rtals is not pounding and dispensing).

material and to exclude naturally oc- meaningful in this case because NRC Four commenters objected to NRC's curring and accelerator produced ra. regulates, among other things. receipt, licensing nuclear pharmacies to dis.

dioactive mater:al. possession use and transfer of byprod. tribute only those products that they One commenter. in oppoettion to uct. source and special nuclear materi. have prepared from FDA approved NRC's regulauon of patient redisuon al in protecting the health and safety radiopharmamucals or nagent Mts.

safety suggtsted that NRC ilmit its af the public. One commenter cited the practice of role to the radiation cafety of the hos, nuclear pharmacies supplying radio.

pital staff and the general pauent E corm on SFactric taavns chemicals to researchers who use population. He Selleses that patient Th8

• them on humans under their own dostmetry is a respontibility of the in. 81 88m N nl8 On th* FDA " Notice of Claimed Investigation.

dividual instituuon Lnd not NRC. This 4U88 88 0 M88rting M18adminl8tra- al Exemption for a New Drug"(IND).

commenter feels that NRC should Lions of radioactin material. Three One commecter noted that FDA per.

first require adequate stal!!ng. clud. commenters opposed any taisadmint> mits nuclear pharmacies to operate in ing a board certLfled physician or rar tration reporting and three com. the absence of a final detettnination of diopharmacist and a redlauen safety menten offemd suggestions on how their status, providing they meet all officer, and then essenually leave the they should be reported. All of the State and local pharmaceutical regula.

insutution alone regarding dostmetry essassents wSI be considemd in dealing uans. *2e two other commenters instrumentauen. calibrauon. drug pry with NRC's newly proposed enha. charactertsed the NRC's restrictions curement or any other function one. letration Noorting requirement that on the distribution of sidered to be the practice of medic.ne. was published in the Fassmas. Rastsesa radiopharmaceuticals by nuclear phar.

NRC does require the Hemaama to for pubtle comssent on July 7.1978 (43 macies as an unwarranted intrusion staff its operation with a radistica FR 39397L into the practice of pharmacy which is safety officer and a physician (nog Then wem sis ===gts on the spo. Ngulated by the States.

necessarily board couflod) trained to cifle issue of paramedical training. NRC licenses nuclear pharmacies to administer redloacuve seaterial or re, 'mros comunenters believe that it is distribute radioactive drugs that have diation to patienta. However, the Com. unnecessary for NRC to become in. been approved by FDA. This includes mission cannot limit its regulatory role volved in paramdical training because radioacuve drugs subject to an TVA.

to protecting the hospital teaff and several organisations are alnady pre approved "New Drug Application" the seneral patient population and ag viding or developing minimum stand. (NDA), or "Nouce of Claimed Investo the same time fulfillits congressional ards, guidelines or certificauon. One gauonal Exemption for a New Drug" mandate to protect the health and -maatar believed that NRC should MD). NRC relles on FDA approsal of safety of the public as regards source, be lavolved in this area because the radioactive drugs because NRC has byproduct and special nuclear matert. technologist. not the physiciar does not regulated the safety and effective.

at The patient being treated or ding. most of the wortt with radio?aopes. ness of radhun dms: since 19E nosed with radioactive material, as Two commenters believe that radiolog. Also, there are not many States that well as the general public who may be leal physicists should be separated out are equipped to regulate radioactive exposed to radiation as a result of that from other paramedical personnel and dmg safety and eHecunness.

treatment, are all members of the one of these coaunenters offered a Dated at Washington, D.C. this 1st pubtle to be protected by NRC, definition of radiolostcal physicist. day of February 1919.

e reggeAt s96ttf88. VOL, 44. iso. 39.JeSaY, PflegasY e, ter9

- - * - m -4 .* ...m .__. .ma +..-.m--=.w- m4 4~- mL---- + *-- *4===w= num**4- .'a-- =~--we-**4 6" m--.a-- %m 4===m= '+-+ =~a- *. . . * --m.~ - ---m-

. . - . . - . . - - a- - - = - - - -a-._~ .-4. .-,.,m..u . 5 4 = -

O O +

O 0

~

MEMORANDUM OF UNDERSTANDING (MOU)

U.S. NUCLEAR REGULATORY COMMISSION AND

U.S. FOOD AND DRUG ADMINISTATION l

l

l l

i Since NRC and FDA both regulate medical' devices and radiopharmaceuticals containing radioactive materials, there is a need to:

e Clarify the Roles of Each Agency 4

• Formalize and Facilitate Information Flow e Develop Mechanisms of Exchange i

I i

I

[

O O O i

r e Originally Signed - August 26,1993 e Duration - 3 years e Annual Meeting to Evaluate Effectiveness i

! I I

t' i

F f

i i

Annual Meeting - August 8,1996,

. Both NRC and FDA Liaison Officers Agreed to Renew MOU 7

i i

4 O O ,

i

,m4m ,m vma m mm , - -w--,----mm-w--

t.

l l

l 1

1 9

9 l O i

1 i

I 8

1 O l l

2 1

1

i Official Trcnscript cf Prscesdings l i

O NUCLEAR REGULATORY COMMISSION  !

l

Title:

Advisory Committee on the

! Medical Uses of Isotopes i

! Docket Number: (not applicable)

! 1 l l i l i

Location: Rockville, Maryland

I l

lO V Date: Friday, November 15,1996 I

l Work Order No.: NRC-910 Pages 328-527 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

O Washington, D.C. 20005 (202) 234-4433

4 1

i 1

(

4 4

i DI5 CLAIMER 1

PUBLIC NOTICE

) BY THE l

UNITED STATES NUCLEAR REGULATORY COMMISSION'S ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 1

, NOVEMBER 15 , 1996 ,

i The contents of this transcript of the

proceedings of the United States Nuclear Regulatory l Commission's Advisory Committee on the Medical Uses of Isotopes on November 15, 1996, as reported herein, is a i

record of the discussions recorded at the meeting held on the

) above date.

3 This transcript has not been reviewed, corrected l and edited and it may contain inaccuracies.

1 I

1 i

i 1

l l

l l

i i

O '

I NEAL R. GROSS count neronians Ano Twecamens l 1323 RM00E BR#C AVE., N.W. '

(2110 23Md33 W49tBIGTON.0.C. M (200 23H433

1 328 '

1 UNITED STATES OF AMERICA 2

NUCLEAR REGULATORY COMMISSION 3 +++++

4 ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES 5 (ACMUI) 1 6 +++++

7

• FRIDAY 8 NOVEMBER 15, 1996 9 +++++

10 ROCKVILLE, MARYLAND 11 The Advisory Committee met at the Nuclear j 12 Regulatory Commission, Two White Flint North, 11565 13 Rockville Pike, Room T2B3, At 8:00 a.m., Judith' Anne N. j

's 14 Stitt, Chairman, presiding.

15 MEMBERS PRESENT:  !

16 JUDITH ANNE STITT, M.D. Chairman 17 JUDITH I. BROWN Member 18 DANIEL F. FLYNN, M.D. Member 19 JOHN GRAHAM Member 20 ANDREW KANG, M.D. Member 21 WIL B. NELP, M.D. Member 22 DENNIS PS. SWANSON, M.S., B.C.N.P. Member 23 LOUIS K. WAGNER, M.D. Member 24 THERESA WALKUP, C.M.D. Member 25 JEFFREY F. WILLIAMSON Member v

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE N.W.

(202) 23M WASHINGTON, D.C. 20005 3701 (202) 234 4433

329 I

1 INVITED GUESTS:  !

n-2 NAOMI ALAZRAKI, M.D.

3 JILL LIPOTI 4

5 ACMUI STAFF:

6 TORRE TAYLOR  !

7 ~l 8 ALSO PRESENT:

9 JIM SMITH '

10 MANUEL CERQUERIA 11 CYNTHI7. JONES 12 MARK ROTMAN I 13 JOSEPH DeCICCO l 14 LARRY CAMPER i 15 SALLY MERCHANT 16 17 -

18  !

19 -

20 21 j

22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHWGTON, D.C. 20006 3701 (202) 234 4433

{

l

l 330 1 1 A-G-E-N-D-A l

2 Acenda Item Pace  ;

)

3 Strategic Assessment and Discussion of Direction )

4 Setting Issue Papers 331 5 Regulatory Authorization for Intravascular 6 Brachytherapy 371 7 Security and Control Issues of Byproduct Materials 1 8 in Medical and University Settings 408 9 Inspection Guidance'for Final Patient Release Rule 463 10 Administrative Issues 502 11 12 13 14 15 16 17 '

18 19 20 21 22 I

23 l 24 2e NEAL R. GROSS e

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

> a --n -+ . . , . s. -. s _ . . . - a e a ., _s, s 331 1

P-R-O-C-E-E-D-I-N-G-S

('% 2 (8:09 a.m.)

N ,)g -

~

3 CHAIRMAN STITT: Good morning. Everybody 4 rested, ready to roll? We've got a great agenda. We have 5 made a change, and that is that the last hour starting at 6 11:45, the status reports are going to be handed to us in 7 paragraph form because that is our hour where we're going I 8 to finish off the business that we started yesterday, the 9 part that has to do with every form of tyranny over the 10 mind of men and w3 men.  !

11 That's -- I'm just reading my coffee cup into 12 the record there. Oh, --

13 MR. CAMPER: Let the record show it.

[ h

'\ m / 14 CHAIRMAN STITT: Right. So, the exciting l 15 business of this morning is to talk about a totally non-16 controversial topic, intravascular brachytherapy. And Jim 17 Smith is the presenter. We're going to talk about 18 development of performance criteria, training, and 19 experience. So we are actually going to go back to the 20 business that's on the table.

21 Let me do it now, Naomi, so you get to 22 participate. We've shifted the brachytherapy for the next 23 agenda item so you'll still be here.

24 Ready to review -- we tabled the motion 25 yesterday. We were working on the medical policy NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON D.C. 20005 3701 (202) 23 4 433

332 1 atetcm nt, the thrce points. And John Graham had made a 2 motion that end point number two of the Medical Policy 3 Statement, that we made it read "the NRC will regulate the 4 radiation safety of patients where justified by the high 5 risk to patients and where voluntary standards or 6 compliance with these standards are inadequate."

7 So, the recommendation is to insert "high".

8 We've had a lot of discussion, a lot of after meeting 9 discussions; and I think our minds are clear this morning.

10 We've got enough coffee on board. So we had tabled that 11 motion yesterday. Do you have to un-table it to get it 12 out, or you just keep going?

13 DR. ALAZRAKI: I would move that we un-table 14 it.

15 MS. LIPOTI: You can't move.

16 DR. ALAZRAKI: Oh, I can't move?

17 MEMBER WAGNER: I would move.

18 MEMBER GRAHAM: Yes, I can make a motion to 19 bring it back on the table.

20 MEMBER WILLIAMSON: Second.

21 CHAIRMAN STITT: Second by Dr. Williamson.

22 vote -- everybody want to get that off the table? All 23 right, it's ready for discussion. We have the right hand 24 and the left hend. Who would like to start?

25 Jill?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

!. - 333 1" MS. LIPOTI: Well, I had-some thoughts last

_, 2 night,.and I came in early so I could write them on th'e

+

3 board. As I had mentioned to you, I really thought that j 4 what we needed to do was on the sort of way to

! 'S- differentiate what is.a-high risk and what is less a risk.

6 And I think that you will have as a gut level 3

7 feeling what is a high risk and what is a lower risk; but i'

[ 8 that you perhaps have not brought that ' from' a sp2t level 9 feeling into scientific literature -- here is how we make 10 -- how we draw the line.

11 And so, one of the ways that you might 12 consider drawing that line is to make a list of what is 13 high and what is low. And then that will assist you in C\-

\~s/ 14 figuring out where you believe the division to be made.'

15 What I have done is listed some of the 16 modalities that you might consider in decid.ing where the 17 risks lie. And I would suggest that for each of these, i 18 there is an inherent risk. U There is a probability of 19 incident, which I think we could get from the statistics 20 that Sally presented yesterday in terms of 21 misadministrations per number of procedures performed.

22 .And we think the probability of incident for 23 most of these_is i'n the 10.4 level. But then, I think 24- another important.part is the consequence. And I divided 25 the consequence. Yesterday,'I just said consequence. But NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISt.AND AVE., N.W.

(202) 2364433 WASHMGTON, D.C. 20005-3701 (202) 2M

e 334 i

1 1 wh n I thought about it soma more, there were various 2 consequences.

3 The consequences could be to the patient, l

4 which is what you're discussing right now in dealing with l

5 the change to this medical policy; or it could be to the 6 worker, to the public, or to the environment. My 7 particular concern is when sources get released to the 8 environment; and then there are consequences whether -

l 9 they're smelted in a scrap metal facility and brought back 10 as fence posts or table legs; or whether they're simply 11 found on their way to a resource recovery unit, 12 incinerator, or land fill.

13 So, I think there are various types of risks 14 and consequences that you could reach for each of these.

15 Now, you will notice that I have included many things that 16 are not part of this advisory committee's work. For l

17 instance, x-ray inspection mammography; credentialiog of l

18 radiologic technologists, nuclear medicine technologists, 19 particle accelerators, radon and NESHAPS. i l

20 I believe strongly that you have to put this f 21 into some sort of perspective. That if you are going to 22 talk to the public and tell them that you are going to 1

23 deregulate items of low risk, they need to have the l

24 perspective in relation to many other things that they 25 come in contact with. So I would suggest that you extend l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

335

1 your thinking to many of these other areas.

2 Now, to control any of these risks, you have a 3 menu of regulatory options. And this is the menu that I 4 drew up preliminarily. But, of course, you can think of 5 many more. Some of the menu might be prescriptive t

1 6 regulations or performance based regulations, j- 7 qualification of user,. voluntary compliance with 8 professional society standards.

9 And I believe someone brought.up an ACNP -

10 procedure yesterday. But there are many other.

11 profeosional societies that might set standards.

12 Voluntary compliance with corporate standards -- I was 13 thinking in particular of Iso standards; or perhaps some

\d 14 standards that are set by-an insurance company.

15 I'm sure Mr. Graham c'an probably talk about 16 the requirements that he has as a hospital administrator 17 that set in motion many other things. So there are 18 standards that he, as a hospital, complies with that may 19 not be strictly NRC standards.

20 And then, I guess the last point is the media 21 and consumer pressure. Some of what brought about the IOM 22 study was the Cleveland Plain Dealer article. And so, 23 that the public, through the media, does have an influence 24 on what they decide is high risk or low risk; and the 25 public has an effect on Congress which tells the NRC what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

336 1 to do.

l 2 So that was my thinking. There it is.

3 CHAIRMAN STITT:

l Comments. Jeff?

l 4 MEMBER WILLIAMSON: Well, I think it's a sort l

5 of an excellent framework for us to proceed in discussing  ;

l, 6 the risk levels of the different procedures, which I  !

i 7 understand is one of the things the Commission would like 8 i to hear che -- our opinion of. '

' l 9 I guess we're in a sort of still preliminary l 10 mode where we're sort of trying to address under what 11 circumstances do we think it's appropriate for there to be 1

12 regulations that basically regulate patient safety and I l

13 technical quality of treatment.

14 And we're kind of -- so, in that sense, I i 15 think perhaps we should figure out how to phrase or j 16 express our conEn 'us senti' ment about that point before 17 maybe proceeding with this more detailed analysis.

18 CHAIRMAN STITT: So your comment would be to 19 try to make a general statement that we can make sure and 20 get to the -- into our minutes that the Commission would 21 read, and then spend time at a different meeting looking 22 at some specifics.

23 Let's have Lou and then Naomi.

24 MEMBER WAGNER: I'd like to just address this 25 to John Graham since he made the motion. I was looking NEAL R. GROSS COURT REPORTERS AND TPNISCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

l 337 1 over this itcm numbar two, and I thought mtyba that wa f-~s

\

2 could come to a phraseology which I think would be I

(

's- 3 acceptable to all; and Dan Flynn may want to comment too.

l J

4 But I think one of the things that I don't  !

5 like about the phraseology presently is that it says it's 6 justified by the high risk to patients. And then.it goes 7 on to say "and where voluntary standards or compliance 4

8 with these standards are inadequate." In other words, 9 it's not tying risk to that second part,.where I think our i

10 intention is to tie risk to that second part.

11 And so, I thought maybe it would be better to 12 rephrase it as the I-] lowing: "The NRC will regulate the 1

13 radiation safety of patients in high risk procedures such -

O

(_,)

14 as HDR where voluntary standards or compliance with these 1

4 15 standards are inadequate."  ;

16 And I'd just like to hear what John and Dan 17 have to say about that kind of a proposal. l i

i 18 CHAIRMAN STITT: So we're discussing this.

19 We're not making a motion yet?

20 MEMBER WAGNER: No, I'm not making any motion.

21 CHAIRMAN STITT: That's the easiest way is 22 just to do some discussion. John -- well, Naomi had her 23 hand up first.

24 DR. ALAZRAKI: Well, just to make a comment --

f%s-25 brief comment about Lou, and then I'll say what I wanted l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D C. 20006-3701 (202) 234-4433

338 1 to ecy. And whtt you enid, Lou, I would agree with that.

2 I might not put into the motion "such as HDR," but just 3 leave it general.

l 4 MEMBER WAGNER: Okay.

5 DR. ALAZRAKI: And I would -- I think that's 6 an improvement over what we had. But my comment was that 7 Jill -- what Ji.tl did is very useful, and it's something 8 which we should do. I don't think it's something we can ,

9 do -- you, as a full committee, can do here during the -

10 time that you have; but something which could be done by 11 one or two members and brought back to the committee as a 12 proposal perhaps that could be then discussed if you want 13 to give the Commission a list of what you consider to be 14 high risk and what you consider to be low risk or no risk.

15 But it doesn't change"our -- change the 16 sentiment that we have to go ahead and present this motion 17 as modified perhaps by Lou.

18 CHAIRMAN STITT: M .1, and then Larry.

19 MEMBER GRAHAM: Could you just repeat your I

20 suggestion? i l

l 1

21 MEMBER WAGNER: Yes; "the NRC will regulate  !

22 the radiation safety of patients in high risk procedures 23 where voluntary standards or compliance with these 24 standards are inadequate." And I'd also suggest that 25 maybe when we say high risk procedures, we say "such as NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

339 1 HDR"; but I'm amannble to leaving that out is the 2

' I ch committee thinks it would be best to leave that out. l U 3 But that would be the modification that I 4

i think is better. And the reason I think that's better is 5 because the phraseology as it currently stands, it puts in 6 two different types of qualifiers. One is high -- is risk 7 to patients; and the other is where voluntary standards or l i

I 8 compliance with these standards are inadequate.

1 P

9 And that could mean any procedure where that's J i

10 the case, according to the NRC. And I think the way we 11 phrase it, we tie it down to the high risk procedures.

12 MEMBER GRAHAM: Let me clarify at least my 13 understanding of the interpretation of statement number 1

4

\g) 14 two. And the critical difference is between the use of 15 "and" versus "or" prior to the word "where". If we wrote J 16 this to state "the NRC will regulate the radiation safety

17 of patients where justified'by the risk to pmrients or 1 18 where voluntary standards or compliance with these 19 standards are inadequate," then indeed, we've opened 20 Pandora's box where, if either condition applies, --

l 21 MEMBER WAGNER: Yeah.

22 MEMBER GRAHAM: -- regulatory impact takes 23 effect. I'm proposing a motion that, first of all, sets a 24 condition that it has to be high risk to patients. Given )

O g 25 that you've passed the first hurdle, then you still, l

L NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 6 1323 RHODE ISLAND AVE., N.W.  !

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433 i

~

340 1 bactura of tho "cnd" -- now you hnva to gat over the 2 second hurdle.

3 In addition to it being high risk, and "where 4

voluntary standards or compliance with these standards are 5 inadequate."

So you can have -- and that was clearly the 6 intent. Here you had HDR, which is a high risk procedure; 7 and there were excellent voluntary standards with an 8 extremely high level of compliance.

9 There would be no significant radiation safety 10 issue that would be regulated. The problem I have with 11 limiting that down to procedures is that potentially there 12 could be radiation safety issues that affect patients that 13 are not the procedure itself where, if the standards all 14 failed and it wasn't the procedure itself, there still 15 could be a potentially high risk.

16 So I am trying to safeguard this -- our role 17 in protecting public safety at the same time, that we 18 eliminate a lot of what may be less then cost beneficial 19 regulation.

20 CHAIRMAN STITT: John, I have a question for 21 you. Do you want "and" out? Do you want "or" in? Or do 22 you like Lou's comma?

23 MEMBER GRAHAM: Oh, no. Very definitely "and" l 24 is there for a reason.

25 CHAIRMAN STITT: Right.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000# 3701 (202) 234 4433

341 1 MEMBER GRAHAM: The "and" makes it additive.

f-~ 2 Both those things would have to be a condition before this  !

~(

\- ' ' ,

, 3 would kick in.  !

4 MEMBER WAGNER: As long as that's clear, I've i

5 got no problem with it as you stated it. And I'd like to i

6 ma).e sure that'that's clear, that they are inclusive, that 7 that "and" is indeed an "and", meaning -- and just as 8 another type of thing they can get around it.

9 CHAIRMAN STITT: Larry, and then Jeff.

10 MR. CAMPER: John Graham asked me if I would l 11 repeat the. suggestion that I made yesterday afternoon.

4 12 And I'll be happy to do that, and what I would offer to 13 the committee for your consideration would be the

)

h

[/

(, 14 following:

1 15 Yesterday afternoon, when I made the 16 suggestion that I did for consideration as a motion, I did 17 so because it was clear to me that you were struggling and 18 wrestling with specific words. And I suspect when they l 1

19 drafted the constitution, they went through the same  !

I 20 process, but they were locked in the constitutional hall

' i 21 in the hot, sweaty summer until they came out with 22 something.

23 I think that what you're trying to deal with 24 is an extremely important area. I mean, what you're I 25 really saying is the 1979 Medical Policy Statement needs

.-l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.

(202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

342 1 to ba revieited. And I think it's far biggar than 2 inserting the word high, trying to find the right 3 modifiers, and so forth.

4 And what I suggested to you yesterday 5 afternoon is that you might consider making a motion that 6 would incorporate certain things. And I think those i 7 things are that you believe the 1979 Medical Policy 8 Statement needs to be. revised; you think that the basis 9 for the 1979 Policy Statement needs to be reexamined; and 10 that you are prepared to work with the staff for said I 11 revision, for said examination of the basis; and to work 12 with the staff or establishing those modalities which are i 13 high risk in nature.

14 And, I think picking up on Jeffrey's point as 15 part of that process, you might want to establish a basis l 16 for regulation of patient safety. And my suggestion to 17 you then -- and I would repeat it at John's request -- is 18 that you make a broader motion because this is not the end 19 of it.

20 I mean, this is only the beginning of t.his 21 process. I mean, for example, we could have an agenda 22 item in the spring meeting where time would be allotted 23 for specific discussion, analysis, etc., of the 1979 24 Medical Policy Statement.

. 25 I think that in doing that, you're sending a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

343 1 signal to tha Comminaion that upon examination of the '79 i f'~% 2 Policy Statement, we think that that's one of the bases k,

. 3 for how we got to where we are today and it needs to be 4 reexamined. Just --

that's the suggestion.

5 CHAIRMAN STITT: Well, I think that's the 6 assignment of the group. And as we've had. time to think i 7 about it and talk about it, get some sleep over it, we  !

8 want to make a statement to the commission. They have- l 9 asked us for guidance on low risk medical activities, and i 1 10 I think we need to try to link some of these things.

11 And if we're struggling with words, which we

12 are, we certainly need to get our sentiments on the books t

i 13- as being very specific.e

~

14 Jeff? 1 J

15 MEMBER WILLIAMSON: Yes, I want to support, I l 16 think, the approach that Larry has suggeste.d. I think our 17 job is not to try and be wordsmiths and make regulations 18 word for word to replace the ones that we disagree with 19 that the Commission has put into place.

?

20 We're trying to sort of echo a broad 1 .

21 centiment. For example -- so I would, you know, speak i

22 against this sort of very specific approach to try and 23 amend comma by comma and word by word this statement. I 24 think it does need revision, but I don't think we can just i

y 25 insert the word risk in there because that is ambiguous.

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS i

1323 RHoDE ISt.AND AVE.. N.W.

, (202) 23 4 433 WASHINGTON, D.C. 20005-3701 (202) 23H433

344 l

1 It fnile to dictinguich between procedures 2 which have inherently high medical risk to the patient, 3 even if carried out perfectly such as definitive radiation 4 therapy for carcinoma of the cervix. It's a high risk 5 procedure. It has 15% serious complications in most 6 practitioners' hands.

7 What we really mean, I think, is what we're --

8 we're trying to say that regulations should not be made to ,

1 9 regulate the sort of technical conduct of treatment'

't 10 delivery except where the consequences of technical errors j 1

11 are -- have severe -- potentially severe clinical  !

12 consequences for the patient; and the normal practice 1 l

l 13 patterns are not adequate to ensure that the incidence or 14 rate of those technical errors is at an acceptably low 15 level.

16 And I think, you know, good arguments could be

17 made that the current regulatory paradigm or many of the 18 particulars of the current regulatory system, you know, 19 fail those criteria.

4 e

20 CHAIRMAN STITT: I want to get some more 21 comments, and then we'll deal with the motion.

22 Jill, Dan, and Dennis, be thinkitg; because 23 you're going to have to say something.

24 MS. LIPOTI: I think that one thing that 25 Larry's proposal brings is that it brings in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

, 345 i 1 consideration of cost, and I think thet'n a very important

,7 g , 2 discussion for this group to have. You can regulate i

\~ '! 3 anything down to the nth degree, and you can say of every 4 single person but is it worth the cost, and the cost to 5 society.

6 If the American people have decided that c

7 government should get smaller, then government can't check l 1

8 on all of these things. And if the American people have 9 decided that health care costs too much, then you need to

10 consider cost with the regulation. And Larry's point gets i l 11 to that; whereas the Medical Policy Statement does not 12 include any statement of cost.

13 CHAIRMAN STITT: Dan.

/

h 14 MEMBER FLYNN: I sort of partially disagree is with Jeff in that we passed a resolution yesterday which 16 made it clear that we thought that maybe uniformity of 17 regulations of radiation would be what we really again 18 recommend by a non-regulatory body. But, assuming that 19 didn't happen since that requires a lot of congressional j

20. action, then we look at the Medical Policy Statement.

21 And if the Commission is asking us to make --

22 hoping that we will assist them in determining high versus 23 low risk, I think that if we did just insert the high with 24 high risk and then work to define what high risk and low

()

%./

25 risk is; at the same time, you know, sending a message to NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

346 1

th;m thtt wa don't cgrca with the 1979 MCdical Policy 2

Statement as written, because you could also -- I mean, 3 you could also insert the NRC will regulate in a cost 4 effective manner the radiation safety of patients where 5 justified by the high risk to patients.

)

6 You could add cost effective if you wish,  !

7 because then you would bring in the -- you know, a ton of 8 paperwork that maybe used now to regulate diagnostic 9 levels of nuclear medicine, which may be not necessary. I 10 So, we're already telling the Commission that 1

11 we believe that the radiation should be regulated in a l l

12 uniform manner by some federal body that should be medical 13 or health oriented and not regulatory oriented. But that 14 -- if that doesn't happen, then they're asking us to help 91 15 them -- advise them as to can we give them any advice as 16 to what is high risk and low risk.

17 That's how I understand the message that 18 you're sending us. Is that right?

19 CHAIRMAN STITT: Well, there's certainly a 20 comment that we have a commissioner's preliminary views.

21 And it discusses options two and three in there -- asking 22 to consult with the ACMUI to receive guidance on low risk i

23 medical activities.

24 I also think that passing the motion, if we  !

25 wish to, and making a commentary, are not exclusive of one NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

1 (202) 234 4 433 WASHINGTON, D.C. 20005 3701 (202) 2344433  !

l

347 1 cnothcr. I maan, it's actually vary complem:ntary. In 1

2 fact, if we send something regarding the Medical Policy 2 b 3 Statement, I think we need to have some description of 4 what our thoughts are, what we'd like to -- where we'd

5 like to see this go.

6 And just as a commentary, Wagner's book that 7 discusses risk and -- has a very nice section about cost.

8 And you can, at a certain cost, get assessments very, '

i

• 9 very, very low. And '79 was a very long time ago when 10 you're talking about health care, and cost of health' care, i

1 11 and the cost of health care regulation.

12 So I think those are important issues.

4 13 Jill, and then --

14 MS. LIPOTI: With your permission, I'd like to 15 -- I have a slide on radiation interventions and their 16 cost per life year saved that'I'd like to share with you.

i 17 CHAIRMAN STITT: All right.

4 18 MS. LIPOTI: It's from the society of risk 4

19 analysis.

}

l 20 CHAIRMAN STITT: Jill, where is this from?

j 21 MS. LIPOTI: The Society of Risk Analysis.

4 22 It's an organization, I believe, from Harvard.

4 23 I don't think I really need to say anything 24 about this. It's just various radiation interventions.

_f 25 The least costly and the most cost effective is automatic NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS

. 1323 RHODE ISLAND AVE., N.W, j (202) 234 4433 WASHNGTON, D.C. 2000lk3701 (202) 234 4433 1

348

, 1 collimatora on x-ray mschinss followed by radon 2 remediation, regardlesi. of what you feel about radon as a 3 risk.

l l

l 4 5

6 7

8 9

10 11 12 13 14 15 16 17

- 18 l

l 19 20 21 l

22 l 23 -

24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23N WASHINGTON, D.C. 20005 3701 (202) 23M 1

349 1

(8:30 a.m.)

f~x 2 And we were discussing yesterday some ALARA 1

)

3 procedures. Radiation standard as low as reasonably 4 achievable for nuclear power plants, the cost is $2.5 5 million per life year saved. Some of the other things 6 that the Nuclear Regulatory Commission does is deal with  !

7 radionuclide emissions, and those are extremely costly 8 programs.

9 CHAIRMAN STITT: Can we get a copy of --

i 10 MS. LIPOTI: If she's willing to let me make a

, 11 copy. l i

12 CHAIRMAN STITT: Could we make a copy of that 4

13 --

[ \

(j 14 MS. LIPOTI

Sure.

i 15 CHAIRMAN STITT: -- and make sure the numbers 16 have -- let her finish, Wil.

17 MS. LIPOTI

There's a bunch of other things 18 that government could do, and the costs.

19 CHAIRMAN STITT: There's an article -- I don't 20 remember which group. It's not the Harvard group.

21 There's about a six page, small font list of cost per life 22 year saved, and it goes everywhere from flu shots to 23 childhood immunization, seat belts; and these are -- if 24 this is abstracted from that, it's an interesting article

/7 i ) 25 when you start looking at cost.

V NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

350 1 Wil?

2 MEMBER NELP: Would you put your first slide 3 up? This is the problem. This is a theoretical, life 4 lost through the low level radiation which we know at low 5 levels there's no evidence that it has any effect on life; 6 and this is an extrapolation from high levels to low 7 levels. And you're falling right back into the same trap.

8 In other words, there is no one who's ever '

9 lost their life because there wasn't a collimator on an.x-10 ray machine. This is taking the old assumptions from the 11 BEIR that have been argued for years and translate them 12 righIt back into the same thing we're talking about. There 13 is no high risk in any one of these individual procedures.

14 This is all a theoretical synopsis of data 15 which we have laid on this table'which I think everyone 16 , agrees has no individual risk to any individual patient at 17 any individual time. So it's the same old argument put on 18 a population basis -- one rem to me is one rem to you, and 19 then you have a million people rem, and now you have a 20 risk.

21 And that isn't the way the world works. And 22 we're going to -- if you start looking at these items and 23 these issues in this perspective, we're not solving the 24 problem.

25 CHAIRMAN STITT: Dan, and then Larry.

NEAL R. GROSS -

COURT REPOR1ERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

l 351 j 1 MEMBER FLYNN: It's not just cost or life

-~ 2- you're -- but there's also -- of course, we've had a few l

\

3 incidents, not many, where disability was the problem -- 1 4 for example, the iodine seed implant for the prostate 5 case. And cancer of the cervix is probably now l 6 approximately 10,000 women per year have brachytherapy as  ;

7 part of their treatment for cancer of the cervix. I 8 And if there are users out there who -- and 1 1

9 there are not very many -- who aren't, you know,-keeping l

10 close track of the doses when they load -- let's say load '

11 an afterloading brachytherapy treatment, don't keep track  !

12 of the time, don't calculate the doses to normal tissues -

/~s 13 - and there are users like that -- those women are at l

,, 14 higher risk than the women who do have the procedure done 15 at centers that pay close attention to normal tissue dose.  !

l 16 And even the centers that pay close attention 17 to normal tissue dose, there's a small risk of 18 complications in the treatment. 'So that would be a -- I 19 think that's fair to say it's a hi,gh risk treatment. It's  ;

20 even higher risk if it's not done with certain quality 21 assurance standards.

22 So there's disability involved there too. A 23 woman may not lose her life; but she may end up with a 24 colostomy; she may have some permanent disability just as f)\

w 25 the prostate cancer patient does. So disability is an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

Hl 352 1 injury -- parm ncnt injury and dicability, and the cost to 2 repair or to manage that disability is part of a -- it's 3 part of the issue also. '

4 MEMBER NELP: High risk should be radiation 5 injury to the patient is what you're saying. l l

6 MR. CAMPER: An observation about Dr. Nelp's 7 comments. Very interesting. Personally, as a health 8 physicist, I certainly share some of his views. What's 9 interesting, from a regulatory standpoint, is the 10 following:

11 The question of extrapolating the consequences 12 to the low dose rates from high dose rates and, for that 13 matter, the very basic underlying hypothesis of the linear 14 no threshold approach, those things are clearly 15 controversial. They're under a great deal of examination 16 at this point in time.

17 The dilemma that this regulatory agency faces 18 is, it is appropriate, we would argue, to follow the 19 guidelines and the lead of the scientific organizations 20 who establish those principles such as the NCRP and the i

21 ICRP and so forth. It's not our role to get -- take the 22 lead in that or to get ahead of the learned scientific 1 23 bodies.

24 What we are doing, on one hand, is trying to 25 support -- and we do: we are supporting through dollars l NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

.353 1 coma.of the rococrch that's. going on in this area. But 2

what this agency has done, and-I think arguably it is

\~s . 3' defensible,'is-that you bring to bear those standards

4. which are developed by the scientific community as' opposed 5 to taking the lead not necessarily,.for example, in 6- cooperation with the scientific community to establish a .

7 different set of standards.

8 So, your points about'the extrapolation j 9 process are valid, 'and that'is why it occurs. '

4 10 MEMBER NELP:

~

May I comment in the same --

1 11 we're struggling with developing high risk and low risk, 12 and not on a theoretical, but on a practical basis for 13 implementation of rules and regulations. And high' risk is

( 14 when you do something when there's likely to be radiation is injury,to that particular patient from that particular. '

16 procedure such as a fistula or something of that sort.

17 CHAIRMAN STITT: I want us to start to focus 18 on where we want to take our discussion, because'we're 19 going to end it by 9:00. If we can't come to a consensus, 20 if we can't think of something we want to say to the 21 Commission, then we'll be without a statement. So start 22 to focus in that direction.

23 Lou, followed by Jeff.

24 MEMBER WAGNER: Just two things. Number one, 25 please don't confuse the regulations that are out there to NEAL R. GROSS court reporters AND TRANSCRBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

• Dl ,

j 354 1

prottet tha public and ars based upon lincar extrapolation 2 with versus regulations that are supposed to protect the I 3 patient. The idea of applying extrapolation to patients '

l 4 when you have this benefit / risk criteria is quite 5 different than when applying it to the public.

6 CHAIRMAN STITT: Absolutely. We do not want i 7 to regulate rectal-vaginal fistulas, folks.

8 MEMBER WAGNER: The other thing is -- John, 9 I'd like to support your motion. What I'd like to know 10 is, do you want to modify 'our motion to incorporate the 11 sentiments expressed by Larry?

12 MEMBER GRAHAM: Can I?

13 CHAIRMAN STITT: Let me have Jeff comment, and 14 then John. Because I'd like to figure out how we want to 15 -- I want to focus on this specific business. We'll have 16 a lot of. time to discuss risk and --

17 MEMBER WILLIAMSON: I was just going to 18 suggest rewording it. I think we're really very close to 19 a consensus. And I think Dan has made really the main l

20 point is that the issue that's at risk is the incremental  ;

l 21 risk between the sort of normal medical risk that patient 22 has from a perfectly done procedure, the additional risk 23 by not doing it according to good technical practice 24 standards. ,

25 So , we're concerned about that either in i

NEAL R. GROSS ,

l COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234M33 WASHINGTON, D.C. 20005-3701 (202) 234M33

355 2

1 absoluto or relative terms. So I think we want to say

/~' 2 that regulation of safety and technical delivery of an 4 - ' 3 ionizing radiation treatments or diagnostic modalities 4- using radioactive nuclides -- regulation should be used as

, 5 sort of the mechanism of last resort only when warranted 6 by a high rate of technical or procedural errors that pose 7 potentially significant consequences for individual

8 patients and when compliance -- when either current i

j 9 practice standards or compliance thereof are inadequate.

10 I think we are on the verge of all perhaps 11 agreeing with something like that -- that that's our 12 definition of high risk for -- with respect to the Medical p- s 13 Practice Statement.

(d 14 CHAIRMAN STITT: John.

15 MEMBER GRAHAM: I've tried to reduce into a i 16 couple of sentences what I think the consensus of this 17 group could be. And it's a procedural question whether we 18 want.to get this typed up and let everybody take a look at 19 it and we revisit this in an hour.

t 20 As a potential amendment to the original 21 motion, and as an introduction to that motion, the ACMUI 22 believes that the 1979 Medical Policy Statement should be 23 reconsidered; and the scientific basis of the 1979 Medical 24 Policy Statement needs to be reviewed with consideration

) 25 of current research and studies; and the ACMUI is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2344433

a 356 1 committcd to working with the staff cnd commissionare to 2 provide guidelines for determination of procedures and 3 activities that range from low risk to high risk to 4 patients.

5 Therefore, the ACMUI recommends -- and then 6 that will just be the recommendation for the modification 7 of the policy. The third paragraph in particular sets the 8 stage that this committee has to hammer out this entire 9 range of how we can protect the public, and yet eliminate 10 a lot of secondary activity.

11 CHAIRMAN STITT: You want to just read that 12 again for everybody so we can think about it? Does 13 anybody want him to put it on an overhead?

14 MEMBER WAGNER: No.

15 CHAIRMAN STITT: Okay, just read it at the 16 same pace you did before. -

17 MEMBER GRAHAM: I'm left-handed, so that would 18 be real tough to read. Okay, --

19 CHAIRMAN STITT: One more time.

20 MEMBER GRAHAM: -- so the motion -- the 21 amendment --

so the beginning of the motion would read:

22 "The ACMUI believes that the 1979 Medical Policy Statement 23 should be reconsidered, and the scientific basis of the 24 1979 Medical Policy Statement needs to be reviewed with 25 consideration of current research and studies, and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

357 l 1 ACMUI is committed to working with tha staff and l i

2- commissioners to provide guidelines for determination of 3

procedures and activities that range from low risk to high l 1

l 4 risk to patients, therefore the ACMUI recommends that the

\

]

i 5 NRC revise its Medical Policy Statement" -- and it's

)

6 simply the insertion of the word "high" in statement j 7 number two. I l

8 CHAIRMAN STITT: All right, comments?

Let me

)

9 just go down this -- we'll just take everybody. Jeff, 10 Theresa, Lou, Dennis -- Dennis just woke up. Let's start J

t l 11 with Dennis.

12 MEMBER SWANSON

I've been listening. I would 13 agree with your statement to making -- up to the point of i

. O( )

14 making a recommendation to change the wording to high i

15 risk. I think insertion of the word high risk is an over 16 simplification of the issues and the problem. My personal 4

17- feeling is that the public is always going to view any level of radiation as a risk.

18 19 And we have to answer to the public's

20. concerns, whether they're a public member or a patient, in 21 dealing with this. I would suggest that you simply end 22 your motion with, you know, the fact that we'll work with i

23 the NRC staff in defining what are low and high risk 24 procedure.

,D 25 You might also want to consider tying it back NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701- (202) 234 6

-1 l

358 1 1

1 to tha rick-inform d p rformnnco-bn:cd evaluacions 2 discussed under DSI 12; particularly option three which 1 3 basically says that what the NRC wants to do is reevaluate ,

1 4 its whole criteria for looking at risk, which takes into i 5 account cost efficiencies, safety issues, so on and so 6 forth.

7 So, you know, that's my general comment.

8 CHAIRMAN STITT: Your comments are really 9 tying DSI 7 with DSI 12, which is how we started our 10 business yesterday.

11 MEMBER SWANSON: Well, it's really tying --

12 going back and taking a look at the Medical Policy 13 Statement in lines with a risk-informed performance-based 14 evaluation.

15 CHAIRMAN STITT: Other comments? Naomi.

16 DR. ALAZRAKI: I just had one basic 17 disagreement, Dennis, with what you said; and that was J

18 that you assumed that since the public considers all 19 radiation, even the lowest level of risk, I think that the 20 ACMUI ought to take the posture that the public needs to I

be better educated by the NRC.

21 22 And the ACMUI perhaps can help it with that, 23 and not to recognize that the lowest levels of radiation i

24 are a risk; because risk to the public has a different 25 meaning, I think, from the way in which we intend it. h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 33

359 1

That in fcct, c3 Lou said yesterday, that risk for very 7-~ 2 low levels of radiation have not been proven as what we k

3 infer from the word risk to be equated with risk.

4 Whereas high risk, high levels of radiation,.

5 therapy, that kind of thing, that's a different thing, and 6 it has to be clearly separated out.

7 MEMBER SWANSON: I don't really disagree with 8 you. I think that those issues would fall out in -- if we '

9 truly did a risk-informed performance-based approach to.

10 analyzing the Medical Policy -- I think they would f'all 11 out. But to simply make the statement that we're only 12 going to regulate high risk procedures without doing that 13 evaluation -- okay, I think is not a -- you know, it's not 14 something that we should jump into right at this point.

15 DR. ALAZRAKI: I thihk the only thing that 16 we'd be doing is telling the Commission that this 17 committee is simply endorsing what was presented in one of 18 the options -- I forget, two or three -- and that is 19 recognizing that low level diagnostic studies don't 20 warrant the same -- because they don't carry the risk, 21 they don't warrant the regulation for all kinds of cost 22 benefit and everything else reasons.

23 CHAIRMAN STITT: Judith?

24 MEMBER BROWN: I just wanted to say that I 25 like John's statement exactly to the point that Dennis

}

NEAL R. GROSS -

court REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

360 1 likes it, and would not vote for any kind of 2 recommendation to change their Medical Policy Statement 3 just out of hand, adding high risk, adding any kind of 4 words; but to reevaluate it and offer the services of the 5 committee to -- for the interest of public education, as 6 Naomi has said, and the education of the Commission is 7 good.

8 And I echo everything Dennis said.

9 CHAIRMAN STITT: Now, I think the point is not 10 necessarily to add words into the policy statement that 11 has existed since '79, but to comment on the policy 12 statement. And we're really saying that we would like to 13 take that -- given what we said yesterday where we 14 reaffirmed our interests that were expressed in the 15 spring, here's a way we'd like to start doing some more 16 work with the NRC commissioners and staff, and it focuses 17 on the Medical Policy Statement of '79.

18 Larry has a comment, and then Theresa.

19 MR. CAMPER: An assistance clarification, if I 20' may. With regards to educating the public, that's an 21 interesting challenge for the agency that I have heard 22 before. And I can readily understand the value in 23 educating the public. I have the same concerns you do.

24 There's clearly a paranoia about radiation risk in this 25 country.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200054 701 (202) 234 4433

a a 4+4.- a u.a.__ - m 4 .-A w -

• _4,.t. m ';1_

. . .M+J _jA1, 361 1

Ba that an it may, tha Nuclear Regulatory i

< ,-s 2 Commission, by virtue of the act which created this

\--

4 3 agency, is a regulatory agency. It is not charged with.

, 4 educating the public. Now, having said that, there is a

5 way though within the charge of a regulator to educate the I 6 public.

7 And the way to do that is,-if we assume for 8 sake of discussion that Part 35 undergoes.a major-4 L 9 revision, and we assume in turn then the. agency changes l l

10 the way in which it reg 21ates low risk activities, I

{ 11 certainly as compared to what we have historically done --

12 the way to educate the public, and I think the ACMUI can 13 play an assistance to us in doing that is, whatever 1 ,0

(_,) 14 changes we make along these lines will have to be clearly 15 laid out and articulated in the statements of l 16 consideration that will accompany the regulation.

17 And those statements of consideration, of 18 course, become published. And it is the most viable means 19 that a regulatory agency.has to educate the public as to 20 why it is changing the basis for its regulations and the 21 posture that it will pursue in the future.

22 And I t.'aink that if we assume that all these 23 things will happen, there will come a time when you will 24 be able to work with the staff to articulate those (9) 25 statements of consideration as to why we are going the NEAL R. GROSS

' COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200( 5 3701 (202) 234 4433

~

362 1 pathwny that wa cro, and that will corve as an educational 2 tool.

1 3 CHAIRMAN STITT: Theresa.

4 MEMBER WALKUP: I'm just wondering instead of 5 adding the word high risk, if we should add excluding low 6 risk activities instead of high risk. Because I think 7 that's ultimately what we want to do is exclude those low 8 risk activities such as diagnostic nuclear medicine. '

And .

9 I think those activities in the end would be easier to 10 define.

11 MEMBER NELP: They've already been excluded.

12 CHAIRMAN S "ITT : No.

l 13 MEMBER WALKUP: Not in this -- what I'm just 14 wondering -- O;l 15 CHAIRMAN STITT: Okay, good comment. Other l l

16 discussion on that point -- Lou, you had your hand up. j 17 MEMBER WAGNER: I just want to say I support 18 everything that John said, and I think we're getting 19 caught up on this issue of high risk. John has qualified 20 his statement with the introduction. It is not a 21 directive to the Commission to change it as we have worded 22 it.

23 All that John did was give an introduction to 24 that to explain to the Commission that we understand that 25 this word high has different interpretations, and we're NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

363 1 willing to work with the Commission to defins what that

,- g 2 word means.

N, 3- We are not making any other statement. And I ,

4 think that -- I really would support what John said, and I i 1

5 would like to see this committee take a vote on this-l 6 because it really isn't a matter that we're trying to 7 change these words or write this for the Commission. We 8 have expressed the sentiment in this motion to help the 9 Commission rewrite it, to help the Commission revisit it.

10 That's the whole intent of what we're doing.

11 And to put that word high in there -- it was put in there l 12 merely to give the signal to the Commission that they need 13 to rethink this risk issue, and that's all it is. It's  !

/O

(_,) 14 nothing -- a definite statement.

15 So I would support in total what John has 16 said.

17 CHAIRMAN STITT: All right, let's see if we 18 can come to some closure on thi's.' You propone that as an 19 amendment to your original motion? Let's go back to where 20 we -- ,

21 MEMBER GRAHAM: So moved.

22 MEMBER FLYNN: I second it.

23 CHAIRMAN STITT: Okay. So we have an 24 amendment to the motion.

25 ,

MEMBER GRAHAM: Original motion.

s NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200(5 3701 (202) 23m

364 1 CHAIRMAN STITT: Okay.

J 2 MEMBER GRAHAM: Would you like that read? l l

3 CHAIRMAN STITT: I would. What are you going 4 to read, the amendment or the motion?

5 MEMBER GRAHAM: I'm going to read the 6 amendment.

7 CHAIRMAN STITT: Okay, because that's where we 8 have to start.

9 MEMBER GRAHAM: Okay, the amendment to the 10 motion would read "the ACMUI believes that the 1979 11 Medical Policy Statement should be reconsidered, and the 12 scientific basis of the 1979 Medical Policy Statement 13 needs to be reviewed with consideration of current 14 research and studies, and the ACMUI is committed to 15 working with the staff and commissioners to provide 16 guidelines for determination of procedures and activities 17 that range from low risk to high risk to patients, 18 therefore the ACMUI recommends" -- that's the end of the l l

19 amendment.

20 CHAIRMAN STITT: And then your -- the next --

21 MEMBER GRAHAM: The motion itself was 1

22 originally that -- the recommendation is "therefore, the 1 23 ACMUI recommends that the NRC revise its Medical Policy 24 Statement to include in statement number two the word 25 'high' before ' risk'."

NEAL R. GROSS COURT REPORTERS AND TPANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

I 365 j 1  !

CHAIRMAN STITT: Wa havo h d a lot of i 7-~s 2 discussion. I'm not sure that there's any further need  ;

! )

\ \

3 for discussion, unless there's some brilliant, original

{

4 comment.

)

5 I'd like to call then for a vote on the 6 amendment that we have heard now three times. Those in 7 favor of the amendment? Those opposed to the amendment?

8 One, two, three -- are we ready to vote on the motion?

9 Judith?  !

10 MEMBER BROWN: Tell me -- the motion is 11 without the last sentence, "therefore we recommend high 12 risk be included?"

13 CHAIRMAN STITT: That's the motion. Okay,

( ,1 14 number two, have high risk added to it.

15 MEMBER WAGNER: But Judy -- but please bear in 16 mind the whole previous idea was to define the fact that  ;

17 this word high is not well defined and that is has to be 18 defined by the Commission. The Commission is left with 19 the ability to define what high is, and we are ready to 20 help them to define the range from low to high. i 21 That's what the amendment says now. So high 22 has no nebulous meaning. It simply gives the Commission 23 the chance to define it for themselves. We're only giving 24 them the message that they need to reconsider the

( ,) ,

25 statement to separate low from high risk. That's all it

'v' NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

366 1 10. And it's no longGr nebulous. It's very wall defin;d 2 as to what we want to do.

3 MEMBER NELP: The problem I have with this is 4 you've reorganized it word-wise to try to say something 5 just because there was a motion on the table. I think you 6 could withdraw your motion and then put in a statement 7 saying we believe this -- it doesn't have to be 8 reconsidered; we think it has to be revised, and we are 9 willing to help to define high and low risk.

10 And what you've done is you've jury-rigged 11 your original motion for the preamble. And when you --

12 when I hear it, it sounds like -- l'ike that. It isn't 13 very straightforward and very plain. So we think should i 14 revise -- not reconsider, but the committee thinks that we G! I 15 should revise this.

16 And in the revision, we'll be willing to help i

17 you and define what high risk procedures are to patients.

18 CHAIRMAN STITT: We jdst voted on the 19 amendment, and there are two folks --

20 MS. TAYLOR: Excuse me, Judy. I didn't --

21 CHAIRMAN STITT: Say again.

22 MS. TAYLOR: I didn't get the vote on that 23 amendment.

24 CHAIRMAN STITT: Okay. And I also need to ask 25 for comments from the negative votes so those can be on NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

l 367 j 1 th3 record too. So the voto -- you want -- okay, those  ;

i 2 who are -- raise your hands again if you voted for. Okay, I_s)

\m / 3 those against the amendment.  !

4 All right, and the three individuals, I'd like i

5 to have comments so that will be on the record also.

6 Judith, go ahead.

7 MEMBER GRAHAM: Start over there.

8 CHAIRMAN STITT: Okay; Dennis.

9 MEMBER SWANSON: I guess I have no problem l l

10 with the amended statement, but the amended statement goes i 11 on to have the final statement which includes the term l 12 high risk. And again, I think that that's an over l l

13 simplification of the issues at hand.

n 14 CHAIRMAN STITT: Okay.

15 MEMBER NELP: I just think the language is l

16 lousy. When you do an amendment in front of a motion like 17 that, I think you ought to withdraw it and say we think 18 this should be revised, and we are willing to help you 19 define high risk procedures to patients. That's what 20 you're saying.

21 And you've done it because there's been a 22 motion on the table, and you've had to work around it from 23 the procedural point of view. And you don't really have 24 to do that. It just --

it's not going to have as much 25 impact if you come back and say here's what we really want NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON. D.C. 20005 3701 (202) 23 4 433

9 368 1 to do.

2 I think it's -- you're caught on the fact that 3 you're under Roberts Rules of Orders, and you had 4 something on the table, and you had to jury-rig it to make 5 it fit what the consensus now is.

6 CHAIRMAN STITT: And Judith?

7 MEMBER BROWN: I echo Dennis again, saying I 8 like the amendment up to the point where it adds the 9 recommendation that'we insert the word high risk.

10 CHAIRMAN STITT: John?

11 MEMBER GRAHAM: Just one brief point of 12 clarification. That was not a -- it was not a jury-rig.

13 It is my clear recommendation that we go beyond 14 recommending to the commissioners that they reconsider the 15 policy.

16 And I think there's a certain onus on us to 17 give them some direction as to how they might pursue that 18 revision, and that word high risk to patients begins to 19 set the stage for that discussion. And it is limited, and 20 I understand all of that; but at least it is something 21 concrete that brings to closure all of the recommendation 22 we've made before, which is that we'll work with them.

23 And frankly, I take as a given the fact that 24 none of us would be sitting here if we weren't committed 25 to working with the Commission to try to make this more '

NEAL R. GROSS COURT REPORTERS AND TRANSCR!BERS 1323 RHoDE ISLAND AVE., N.W. ,

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433 )

_ . _ _ _ _ . _ __ _ _ _ . m .

369 1 rational.

4 2 CHAIRMAN STITT:

i eg\ As well as the fact that 3

they've asked us to do exactly that based on what we got 4 in print. We have a motion that we need to vote on, and 5 that motion is that number two have "high" inserted before 6 " risk". So we need to vote on that.

7 Those in favor of that motion, raise your 8 hands. Counting, Torre? Those opposed? Now we'll ask 9 for comments so that they can appear in the record.

10 Theresa?

11 MEMBER WALKUP: I just feel it's more 12 important to emphasize the low risk excluding that.

13 That's where we need to spend our time right now. I think G

14 the high risk is a given.

15 CHAIRMAN STITT: Dennis?

16 MEMBER SWANSON: I mean, again, it's an over 17 simplification. I have a lot of concerns you have not 18 differentiated the risk associated with the medical 19 procedure itself from the risk associated with things that 20 take place separate from the medical procedure.

21 I think that it's an over simplification of s

22 how the public's going to view that statement, public 23 concerns regarding radiation risk in general. And again, 24 you know, I think it --

simply adding a word doesn't

/

G 25 address the issue.

(

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433

. _ me 370 1 CHAIRMAN STITT: Judith?

2 MEMBER BROWN: I don't like the inclusion of l 3 the word high into their policy statement, so I voted '

4 against it.

5 MEMBER NELP: No comment.

6 CHAIRMAN STITT: Wil has registered as a "no 7 comment." All right, are we done then with -- we are done 8 with the first hour's business.

9 Do you want to move on to intravascular?

10 MR. CAMPER: Yes. I need to make a comment --

11 an administrative comment for the record. We're going to 12 discuss with you today intravascular brachytherapy.

13 Within your package, you'll find information concerning an 14 organization known as Isostent, which was a petition which 15 had been filed with the agency.

16 That petition appears to have been withdrawn, 17 at least temporarily, by Isostent for -- I think they want 18 to make some further adjustments to it. It is provided as 19 an informational source only then at this time. The 20 petition is not a matter of consideration.

21 Rather, we have provided it to you to give you 22 an example of what some of these devices might look like 23 and what petitioners might pursue in terms of seeking 24 approval from the agency. Rather, what we'd like for you 25 to do is focus upon the -- and provide us with some h

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 23M WASHINGTON, D.C. 20005-3701 (202) 274 4433

371 1 assistance on how.we might incorporate intravascular

[n 2 brachytherapy for -- into our regulations.

3 MEMBER BROWN: Can you tell us what IMOB is i

4 next to your name? 1 5 MR. SMITH: Oh, I don't know. That's the new 6 branch I work in. Where are you seeing the IMCB?

7 MEMBER BROWN: It says presenter, Jim Smith, 8 IMOB.

9 MR. SMITH: Oh, okay. I recently changed 10 branches. I work for the Industrial Medical and 11 Operations Branch. I used to work for Larry's branch up 12' until about a month ago. That's why I'm doing this g)

(

V 13 14 because I used to handle this.

parting shot for Larry.

This is sort of like my 15 MR. CAMPER: Jim received a promotion for all l

16 his hard work; and unfortunately, we lost him from our j l

17 branch. But we still like him very much. l 18 MR. SMITH: I know at least one member on the 19 committee here. Jeff is -- has a little bit of background 20' in intravascular. I know he's on the AAPM task group, 21 right? l 22 MEMBER WILLIAMSON: Radiation therapy l 23 committee.

24 MR. SMITH: Oh, okay. Well, I know I've seen

'C 25 you at the task group meetings.

(

I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 2 12 RHODE ISLAND AVE., N.W.

J (202) 2364433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

i 372 1 This was talked about about a year ago. As a 2 matter of fact, most of the briefing package was handed 3 out about a year ago too, the background information on l I

4 intravascular. Approximately a year and a half ago, the 1

5 NRC was made aware that there was some interest in 1

6 performing intravascular brachytherapy to try to prevent 7 restinosis. I l

1 8 Restinosis is -- well, I'm sure you're all' l l

9 mostly doctors and you know what this is. But for the l 10 benefit of the audience, it's a narrowing of the artery l 11 after balloon angioplasty. Basically you get a narrowing 1

12 of the artery greater than 50% in 40-60% of patients that l l

13 are treated.

14 They've tried various medications. I Ol  !

l 15 understand that currently they're trying antibiotics. But 16 so far, they haven't had any success in it. There is the-17 idea that a delivery of radiation to the vessel wall may I

18 prevent this scarring effect, or restinosis, as it's 19 called.

20 There have been animal studies and human 21 studies using brachytherapy treatment following balloon 22 angioplasty in the United States and in Europe. Some of 23 these have shown some promising results. And there's been 24 a lot of interest over the last year and a half by a lot 25 of manufacturers and research groups in pursuing this in h

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

I 37 1 1 the United States.

,/N, 2 Also, it's anticipated that approximately

O 3 400,000 patients a year undergo balloon angioplasty; so the possibility for a large number of brachytherapy i

4 5 treatments being performed in the next year or so is 6 great. 400,000 patients a year would dwarf the number of 7 radiation oncology treatments for brachytherapy _

8 With the idea that these will be performed by 9 cardiologists, the NRC may have to look into changing its 10 regulations as regard to training. Currently, 11 brachytherapy treatment is geared toward oncologists.

, 12 It's our understanding that probably in the future, these ,

,_ 13 will be performed mainly by cardiologists.

(_,/ 14 In addition to that, there's several other 15 problems with it. Our current regulations don't allow for 16 the treatment of intravascular brachytherapy. 35.400 is 17 very specific about the types,of isotopes and uses for 18 each one of those types of sealed sources. In addition to 19 that, 35.400 only allows for use of sealed sources.

i 20 We have several manufacturers who are planning  !

21 to use beta emitting stents, and these are either coated -

22 - there's one that Larry was mentioning -- the isostent 1

l 23 has an ion implanted P-32 stent. And the problem with 24 those is, since they are so close to the surface so the 3 O

( 25 betas can get out, also the radioisotope also gets out.

L

~ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS

! 1323 RHODE ISLAND AVE.. N.W.

[ (202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 23M

r . w l

l , 374 l

l I

1 I believe in the isostents, actually a 1%

2 leaching effect. If you have a brachytherapy source and 3 it's leaking, you automatically have a misadministration l 4 according to our definitions.

5 In an effort to clear up some of the water, in 6 April of '96 we issued an interim guidance on performing 7 intravascular brachytherapy treatments that was included 8 in the FDA guide. Basically this guide points out what a .

9 facility needs to do in order to conduct this type of

• 10 research or treatment.

11 It goes on to state that if you are a broad l

12 scope medical facility who is authorized three to 83 for j 13 medical research, diagnostic, and therapeutic uses of l 14 radionuclides, your committee can -- your IRB -- I'm not 9l I l

15 sure exactly what that -- Investigational Review Board, I i 16 believe, can approve your uses; and you can go ahead under l 17 your current license and not even get authorization from 1

18 the NRC.

19 But if you're a limited specific licensee, 20 you're going to have to come in to the NRC and get an 21 amendment and basically ask us to authorize you to perform 22 these treatments.

23 Let's see, in May of 1996 -- Larry was

! 24 mentioning Isostent. Isostent petitioned the NRC to add 25 an additional section to 10 CFR Part 35 which would NEAL R. GROSS '

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 200054701 (202) 234-4433

375 1 address the training / experience requirements for use of a 2 P-32 ion implanted stent. FDA granted an IDE to Isostent, 3 and we thought.everything was going to be fine because it 4 was our understanding at that time that these IDE studies ,

5 were going to be performed at' broad scope medical 6 facilities.

7 In July / August of 1996, Borges Medical Center,  !

8 a limited specific licensee, approached us and said that 9 they'd like to do it. I'm not really sure if I can tell -

10 you why they decided to do that, but there was some 11 extenuating circumstances is why Borges needed to be one 12 of the facilities that was performing these trials.

,_s 13 The problem we had was that these stents would 14 leach app: ximately 1% of their activity. And like I said 15 earlier, a misadministration would ensue if you viewed l

16 these as 35.400 devices. '

17 The part that we looked at was that these 18 stents on the IDE would originall only have one 19 microcurie of P-32. That's not a lot of activity. And 20 the radiation safety point of view -- you could carry it ,

21 around in your pocket probably and not cause any problems.

22 But we wanted to look at it and see what we 23 could do with it. We thought that perhaps we could look 24 at it as a 35.300 material, unsealed uses of byproduct

[T

( ) 25 material for therapeutic uses. The problem we had with NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE.. N.W.

(202) 236 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

-a --.

376 1 that is 35.300 requires to -- the material come from a 2 32.72 licensee, who is someone who produces and j 3

distributes radiopharmaceuticals for therapy or 4 radiopharmaceuticals, and/or someone who is authorized -- l 1

5 a physician, authorized user, or nuclear pharmacist who 1 i

6 meets the requirements in 35.920. '

7 And we said well, that's really a stretch.

8 What is this nuclear pharmacist going to do with this who 9 receives it in the mail, and what is he actually going to 10 do to prepare it? Probably nothing.

11 So what we did was we gave Borges Medical 12 Center a line item authorization to perform these 13 procedures under the IDE. Under -- and what would happen 14 is -- I think we can go on to the next one. We've allowed 15 them to conduct the implants under the IDE for the 16 cardiologist -- I guess we all understand the cardiologist 17 is actually going to be the one placing these stents and, 18 of course, it's hard -- would be performing the procedure 19 under the supervision of a physician who's authorized 20 under 35.300 for therapeutic uses of P-32.

21 From that viewpoint, the stents are still 22 going to deliver the same kind of dose that an HDR 23 treatment would deliver to the vessel wall. They're not 24 going to deliver as high a dose to the heart tissue or the 25 muscle tissue as an HDR treatment would. But we were i

NEAL R. GROSS '

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON. D.C. 20005 3701 (202) 23M433

--mue 377 1 saying well, P-32 --

there's a safety concern there, but

,m

( J 2 it's more from the occupational point of view; and we want V

3 someone there who understands the uses of P-32, whether or 4 not it's sealed in a -- well, partially sealed within the 5 matrix of a cardiac stent, or whether or not it's a 6 radiopharmaceutical.

7 MEMBER NELP: I'm sorry; how much activity are 1

8 in these devices?

9 MR. SMITH: The first one is one microcurie. j 10 I believe that they have plans to go up to 20 microcuries l

11 under their IDE's, but the first phase of the trials is 12 going to be one microcurie.

,3 13 MR. CAMPER: You indicated that there are a

-- - 14 number of other manufacturers that we are aware that have 15 an interest in -- are there any other -- are we aware of 16 any other activity amounts; or for that matter, isotopes?

17 MR. SMITH: I know that there are people out 18 there who want to use tritium who manufacture it. And I I 19 believe Jeff is --

20 MEMBER WILLIAMSON: The Canadians too.

21 There's some cyclotron produced alternatives that can be 22 made in the nickel titanium stents too.

23 MR. SMITH: And we've heard of other 24 methodologies. And I'm not really sure since they were 25 discussed between us and FDA in sort of closed door NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

378 1 meetings whether I can really go into all the different 2 types.

3 MR. CAMPER: But the point is, the committee 4 should know that there are higher activity levels being 5 considered, and there are other isotopes being considered.

6 CHAIRMAN STITT: I thought iridium-192, the 7 HDR type of sources, was -- it's being actively pursued.

8 MR. CAMPER: That's my understanding.

9 MR. SMITH: Yes, thef have HDR units, they 10 have implanted stents, they have low dose rate seeds also i 11 that are going to be implanted for a period of time and 12 then withdrawn. There's also one particular idea that's a 13 balloon that's going to be filled with a l 14 radiopharmaceutical. l l

15 There are a lot of people out there looking at 16 it. There's a big payoff in the end, I.think, for the 17 group that finds the right approach. But right now, it's 18 still in a research trial, and were not really sure which 19 one is going to pay off or if any of them will pay off.

20 CHAIRMAN STITT: Are we ready for discussion?

21 Jim, do you have more to --

22 MR. SMITH: Let's see, I think I have --

23 CHAIRMAN STITT: Do you have some questions?

24 MR. SMITH: -- well, a few questions. But I 25 think we can discuss it if you'd like. I I

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

M 379 1

Since our regulations currently are very

,[V

- ~

~~'s 2 lacking in this area apparently when they were written in 3 1987 or so, intravascular brachytherapy was never even 4 thought of. We want to know should we alter our training S and experience requirements to allow cardiologists to be 4

6 named as authorized users for this modality.

7 And we would have to further break it up into 8 different parts, I believe, because you have these 9 permanent implants with one or two microcuries up to 20 10 microcuries of an activity; and then you have someone 11 treating with an HDR unit with ten curies of iridium.

12 So .obviously, depending on how you view our 13 training / experience requirements, you may have different

/,_s\

\ I

\_ / 14 avenues of training / experience. Someone.doing permanent 15 implants may not need as much training / experience as 16 someone who's going to do HDR.

17 Should we also include a new section? We have 18 35.400 now, but it's really geared towards uses for 19 treatment of cancer, not intravascular brachytherapy for 20 restinosis. Also -- I think I've already gone over the 21 third item.

22 What is our training experience really geared 23 towards? Is it towards the safety of the people within 24 the institution, or is it because of the risk associated i

a j 25 with the treatment to the patient?

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

380 1 Ch, and this other case of these implanted 2 beta emitters -- we know that they're going to leak. It's 3

a foregone conclusion just the way they're designed.

4 There's always going to be some activity leaching out.

5 But the amount of activity is rather small when you 6 compare it to what someone would normally get from a 7 radiopharmaceutical dose for therapy.

8 Should we make a separate criteria for 9 misadministrations from leaking sources for these beta 10 emitting sources? And are there unique radiation safety 11 considerations? And this is really towards the idea that 12 if the source from an HDR unit becomes dislodged, how are 13 you going to go in and do open heart surgery to remove a 14 source like that?

15 I wouldn't want to be a cardiac surgeon 16 staring at ten curies of iridium the size of a grain'of 17 rice. So there would have to be some special radiation 18 safety considerations.

19 And that's about the end of my -- you can open 20 it for comments.

21 CHAIRMAN STITT: Sure; and we want to make 22 sure and address all of your questions that you've given 23 us.

24 Jeff, you had your hand up. You want to )

25 start?

I NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000M701 (202) 234-4433

_ .=

381 1 MEMBER WILLIAMSON: Okay, yeah. Well, A

/

actually,.I was just going to make some clarification V) 2 3

comments about the different modalities, but you, yoa 4 know, finished up really well.

5 I think it's important to realize there really 6

are a broad range of modalities that are being brought to 7 bear on this problem ranging all the way from conventional high dose rate machine with the ten curie source for 8

9 peripheral arteries to sort of medium strength iridium-192 10 manual sources which have activities on the order of 500 11 millicuries perhaps, hand loaded into the patient, to 12 other catheter based systems that use beta sources with s 13 activities on the order of, oh, ten to 100 mil 11 curies and

\s 14 are held in place manually essentially for a few minutes 15 to deliver a dose of 20 gray.

16 And then there's this other category, the 17 permanent implants, which are perhaps the conceptually 18 most simple. They involve very-low activities, but they 19 do deliver high focal doses. So these are doses well 20 within the traditional therapeutic dose range of 21 brachytherapy.

22 These are a lot of good questions, and I think 23 it's very difficult to answer some of them, especially 24 those involving training and experience requirements

("N

() 25 because it's so -- it's an emerging field. It's not clear NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS I 1323 RHOOE ISLAND AVE., N.W.

(202) 236 4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433  ;

l 382 I 1 how efficacious this modality is going to be in patients.

2 It's not clear how impcrtant being able to review isodose 3 distributions from different competing types of 4 intravascular brachytherapy will be.

l 5 So, it's -- I would say, you know, there may i 6 well be a need for -- even in the perhaps the stent based {

7 patients, to -- for somebody who has the wisdom and 8 experience to be able to look at and help make an 9 assessment what's the best type of competing intravascular 10 therapy for a given patient.

11 The issue of dose response, how accurately the 12 treatment has t.o be delivered, is I think perhaps not 13 known. There's a great deal of debate. What is the 14 target tissue? Is it the media of the arterial vessel?

G, 15 Is it a deeper tissue, the adventitia? Is there going to 16 be a need to go back and -- with the early patients and 17 retrospectively try and make some sort of a dose 18 assessment as to where doses in individual patients were 19 delivered?

20 So I think there's a lot of uncertainty.

21 CHAIRMAN STITT: There are radiopharmacy 22 issues, there are medical physics issues, and they're 23 specific to what isotope; and you know, that has to be 24 part of the training and experience. Let me keep 25 collecting data from the different committee members.

NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

383, 1 Dan, and then Judith.

/N 2 MEMBER FLYNN: Can you go back to number one? I 3 Number one I have a problem with because this is a 4 therapeutic use of an isotope, and there are other 5 considerations which you don't realize. For example, you 6 have 100,000, 200,000 people a year who have external 7 radiation for lung cancer or other thoracic malignancies. j 8 When you give another course of radiation to a 9 site, you have to worry about, you know, the normal tissue 10 tolerances. You have patients that -- let's say you have 11 a radiation oncologist who is used to screening, for 12 example, not many, but patients with collagen vascular p,

13 disease or systemic sclerosis who could have severe m, 14 complications that the cardiologist may not be aware of; '

15 or a patient who has treatment with chemotherapy; or a l l

16 patient with, more commonly, diabetes -- insulin dependent 17 diabetes whose vessels won't tolerate the same radiation 18 dose as a patient without insulin dependent diabetes.

19 And I think that --

I think this is an area 20 that -- at least my own personal opinion would be that 21 like with prostate seed implants which are being done not 22 as a turf battle, but as a team approach with a radiation 23 oncologist who knows the radiation and a urologist who 24 knows the prostate better -- they do it as a team

~

(s,I 25 approach, and there's no turf battle at all.

V NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAho AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

384' l 1

I know in nuclear medicine there are turf 2 battles between nuclear medicine and cardiologists for 3 very low diagnostic levels of radiation where there is no l 4 harm -- potential harm to the patient. Here we're dealing 5 with something much different. Here we're dealing with 6 potential harm to the patient.

7 We're dealing with potentially a cardiologist 8 who administers something that he does not have the -

9 training in terms of the radiation safety aspects, the 10 radiation interaction aspects with chemotherapy or other 11 doses of radiation, or knows that there are certain 12 conditions that patient may have which puts that patient 13 at a very high risk for radiation complications; which in 14 this case could be clearly death. %5 ,r 15 And so, I think that this is a new area, and I 16 think here you have not a battle of turfs between two 17 specialists, but an area which is appropriate where the 18 two specialists get together as has been done already. So 19 I would -- for that reason, I would suggest that you do 20 not extend this to cardiologists who have not had training 21 in therapeutic levels of radiation -- for that reason.

22 MR. CAMPER: Well, let me comment on that, Dr.

I 23 Flynn. The dilemma that we may find ourselves in with l 1

24 regards to your suggestion is that the cardiologist, for 25 example, could petition the agency or could solicit us to NEAL R. GROSS l l COURT REPORTERS AND TRANSCRIBERS I 1323 RHCOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

. 385 1

reconsider our training and experience requirements given

('m

\ 2 that our -- many things, as you just mentioned, I would --

V<

3 they come to me across as being medical competency 4 questions.

5 And of course, we're not into that. What our 6 training is designed to ensure that they can safety use 7 the materials to protect public health and safety. Now, 8 the training and experience requirements that we currently .

9 have today for 35.400 have been around for a long time and 10 have been structured because of the spectrum of isotopes 11 that are included there: cesium-137, iridium, cobalt, 12 some fairly energetic gamma emitters and so forth.

13 The argument might be that well, wait a (V )

14 minute, we really only want to use one microcurie or l l

15 perhaps up to 20 microcuries of P-32; and therefore, in 16 turn, does the level of training and experience .

I 17 necessarily have to be the same? And the concept, from 18 our vantage point -- I don't know how we would cause them 19 to work together to work together as a team.

20 I mean, our regulations, I don't think, can do 21 that. So, with those thoughts then -- I mean, this is why 22 we ask the quention should we alter. What I'm hearing you 23 saying is no, we should not. And I'm only arguing the 24 other side that we might hear.

O i / 25 MEMBER FLYNN: I'm not talking that the V

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 2364433

m 386 1

radiation oncologist should be learning how to do stents, 2

but that the radiation itself should be under the 3

supervision of an auth rized user -- that the radiation 4

itself should be under the supervision of an authorized 5 user.

6 So that the authorized user who's been trained 7

in radiation effects will be -- will, in some cases, for j 8 these low dose rate procedures, be used just to screen the 9 patients and to advise them as to the safe use of the 10 radiation in the patient and the handling of the 11 radiation. The cardiologist doesn't have any training in 12 handling P-32 versus an HDR.

13 To them, some of them may think of it as the 14 same. And when you talk about an HDR source getting 15 broken off in the chest cavity -- well, remember the 16 Indiana, Pennsylvania case where the dose rate of the 17 meter was two rem per hour, or 2,000 millirem per hour for 18 a four curie source.

19 And for a ten curie source, it's about 5,000 20- millirem per hour. And in a lift threatening condition, a 21 surgeon -- it's not going to happen, but if it did happen 22 once in ten years, it's not going to cause injury during 23 an emergency surgical procedure. It will cause an 24 exposure though.

25 It takes -- two hours of a meter, you're going NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

I 387 1 to get a ten rem dose. I mean, if that happens once in a O 2 life time _to save a life, even that's acceptable to save a i

3 life. Because the dose rate is 5,000 millirem per hour to 4

meter for a ten curie source, which is the strongest f

.5 source you have.

6 So a two hour exposure to meter is ten rem --

7 is exactly what the nurses in Indiana, Pennsylvania got by i

8 sitting on the bedside with this patient for five hours 9 getting two rem per hour to meter. So I don't see that as a

10 the major problem because I think if the source breaks off 11 once in a ten year period for a procedure that's being 12 done tens of thousands of times -- you know, you have dose 13 limits in the nuclear power plant to save a life, I Q

h 14 believe, don't you -- emergency responders?

4 15 And how often has that happened? But if it i

16 does happen, at least you know what the emergency 1

4 17 responder's going to get. But I think you need to have an 18 authorized user who understands dose rate; understands 19 time, distance, and shielding; is not going to panic if a 20 source does break off; and can advise the cardiologist and 21 work together as a team.

22 So that -- you do that because it's a -- the 23 stenting is a cardiology procedure. That's a given. But 24 the supervision of the radiation would be from an O

, 25 authorized user who could be a radiation oncologist or, in NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 4701 (202) 234-4433

-- 1

, 388 1

some cases, nuclear medicine; I'm not sure -- but an 2 authorized user.

3 CHAIRMAN STITT: Judith?

4 MEMBER BROWN: Well, at this point, I'd like l 1

5 to near from the cardiologist on the panel. However, we 6 don't have one. I remember, since I've been here five 7 years now and I have some history to draw upon, that I 8 walked.into my first meeting in a huge turf battle, as Dan .

9 is saying. I didn't even know what was going on around '

10 me, but I remember that the cardiologist and the panel 11 representing the rest felt very strongly about this issue.

12 And I'm wondering if we have any credibility 13 at all without someone representing that point of view in 14 saying the same old things we all expect this panel to say 15 absent a cardiologist on the panel. So, I think number, 16 it is going to be very difficult -- it's going to be i i

7.7 impossible for me to judge without being someone l l

18 representing that side. '

19 CHAIRMAN STITT: And we have as a group seen 20 or have sent in responses from the various professional '

21 societies, and they line up exactly as you might expect.

22 ASTRO, American College of Radiology, has a certain 23 viewpoint; the cardiology folks have a different viewpoint 24 on training and experience.

25 But we need to be discussing one in light of NEAL R. GROSS '

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

, -. ~ .. .-

389 1 the types of sources that are being used.

• /] 2 MEMBER NELP: Have they expressed an opinion i

'\j 3

in this area, the cardiovascular -- cardiology group, or

'4 are they sort of --

5 CHAIRMAN STITT: I thought I saw something in 2

6 print at one point.

l 7 MEMBER NELP: Not in the stream yet?

8 CHAIRMAN STITT: Oh, they're definitely in the

9 stream.

i 10 MEMBER NELP: On this issue?

.; 11 MR. CAMPER: Well, I'm sure -- we have not 12 received any formal communication from the cardiology

, 13 community, for example, in terms of a petition to modify s 14 our training or experience. We have not received any 15 formal communication that would solicit us to reconsider 16 our position.

17 What we are trying to do here is we know this 18 is coming; we're trying to stay ahead of it. There's a 19 large patient population obviously, many isotopes 20 apparently, various activities. And what we're trying to 21 do is set the stage to stay ahead of this.

22 And I think what I heard from Dr. Flynn's 23 comments was no, you shouldn't. What you should do is 24 have an authorized user to supervise the use of these Oj g

s 25 material, and I can understand that. I guess from our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVE., N.W.  ;

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433 I

... --s ;

390 1 standpoint -- again, I don't know how -- you know, the l 2

question of the authorized user supervising is something 3 our regulations have embodied within them.

4 I think it happens successfully to varying i 5 degrees. But I'm certainly clearing at least one -- I 6 hearing one no to this.

7 MEMBER FLYNN: But the authorized user has the 1

8 training. And if he doesn't supervise it, it's his 9 license -- he's at risk too for not providing the l

10 supervision and teaching and support to the cardiologist.

11 MR. CAMPER: Well, I think the problem that I 12 have -- the thing that concerns me about the approach 13 you're suggesting -- and I understand where you're coming 14 from and why. But if I go over to question five, the 15 impression that we have -- you want to switch the slide, 16 please?

17 The question that I -- that seems to strike is 18 that these are going to be done'so'mewhere in the 19 institution probably far removed from the radiation 20 oncology department.

21 MEMBER FLYNN: The radiation oncologist goes 22 to the operating room all the time.

23 MR. CAMPER: No, I understand.

24 MEMBER FLYNN: I do.

25 MR. CAMPER: But I'm just saying -- I realize NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON OC. 20005-3701 (202) 234 4433

_ .. _ .. _ _ _ . ._. .___ _ _ . _ _ - _ . _ _ _ __ _ ,_ _ -.m.. _ ._.-. .

391 3

1 that. But'are-you confident that this supervision I 2- approach that you prefer will take place? ,

3 i

MEMBER FLYNN: You're still holding the person f 4 with the training and education responsible to do what is i

5 necessary under the license. I don't want to, you know,

! i put a dig in the NRC; but, for example,'if on strontium 1

1 6 '

'j 7 eye applicators an authorized user who knows'how to \

I i

8 4

calculate half life in Puerto Rico was there to calculate 9 the half life, we'd probably have 100 to 1,000 patients 10 who'weren't overdosed in Puerto Rico recently. ,

i 1 11 But as long as you turn over a radiation.

12 source to someone who doesn't know what a half life means, 13 then I think you're creating a problem, let alone' time, 14 distance,-and' shielding.

15 CHAIRMAN STITT: And there are differences in 16 these isotopes. I mean, the stents that are being placed 17 in a cardiac suite or whatever, there's-some units that 18 are in development that would have high dose rate sources.

19 And where are those going to be housed, shielding is 20 totally different. So again, there's a spectrum of uses 21 based on isotopes, and a lot of it's developmental.

22 Just to prove the point -- and then Naomi will 23 speak and then Sally -- these are two meetings that were 24 held within the past six months on intravascular 4

25 brachytherapy, so this is a hot field, with no pun NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 23H433 WASNINGTON, D.C. 20006 3701 (202) 23M433

_. -~

1

.:n 392 1

1 intended; and it's -- there are more meetings that are {

2 scheduled -- at least three that I know of coming up h

3 within the next nine montto.

4 So, the NRC will be seeing a lot more of this.

5 Naomi, your institutice is actually running some of the 6 meetings.

7 DR. ALAZRAKI: In the booklet that we have, 8 the -- one of the cover pages from the course that was 9 given at Emory, I attended that course. There were 600 10 people at that course, most of whom were cardiologists; 11 about 100 of whom were radiologists and radiation oncology 12 types.

13 And people came to that course thinking that l

14 they were going to learn in two days how to do this new 15 technique, and they were going to go back to their 16 practices and start doing it; which, of course, was 17 ridiculous. The field is in very much an investigative, 18 developmental stage; and most of the people who came to 19 that course had no concept, no idea, of what was involved.

20 I think it's very important that NRC not 21 compromise any kind of training and experience and 22 authorized users who are going to be handling these i l

23 materials and responsible for the care of the radiation 24 not just for protection of the patient, but for protection 25 of personnel.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE N.W.

(202) 2344433 WASHINGTON, D.C. 200014701 (202) 234-4433

.3 393 1 MR. SMITH: One think that I didn't bring out

[D 2 --- the Food and Drug Administration has viewed these 3 types of treatments as significant risk. So, even if 4 'you're.IRB approves it, you still have to go through FDA 5 and get an IDE approved --

6 DR. ALAZRAKI: We have had some near disasters 7 at Emory in the research lab -- not in the cardiac 8 catheterization laboratory, but in the research lab '

9 because really of inexperience and lack of knowledge on 10 the part of people who were involved. You know, I think 11 if the cardiologists really want to be doing this, they 12 will get the training and experience that they need to --

13 which will provide them the credentials that they need to 14 do it.

15 And that ought to be, I think, basic policy 16 that if you're going to be doing this and handling these 17 sources and -- you need to get the necessary training and 18 experience.

19 CHAIRMAN STITT: Naomi, these near disaster --

20 are you talking about personnel and the source handling 21 types of --

22 DR. ALAZRAKI: Right.

23 CHAIRMAN STITT: -- radiation safety to the 24 staff?

25 DR. ALAZRAKI: Basic radiation safety.

, w NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

394 1 CHAIRMAN STITT: Okay. Sally, then John; and 2 we need to hear from your friend from the FDA.

3 MS. MERCHANT: Just quickly to let -- as an 4 additional piece of information, the American College of 5 Cardiology is holding their national meeting this week in 6 New Orleans, and this is a session in that meeting. So I 7 do -- so it's bringing it mainstream to the cardiologists 8 this week.

9 I mean, as far as knowledge being transferred.

10 So I have a tendency to believe that this -- I won't say 11 that the issue will be escalated, but more people will be 12 interested, more people -- so it is a very timely issue.

13 CHAIRMAN STITT: John, you had a comment?

14 MEMBER GRAHAM: Well, the one question I had -

15 - were the near accidents at your site associated with 16 what would be categorized as a high dose source like this 17 balloon angioplasty that's being discussed?

18 DR. ALAZRAKI: No, no.

19 MEMBER GRAHAM: Or are we talking these one 20 microcurie P-32 stents?

21 DR. ALAZRAKI: No, they're -- as Jeff said, 22 they're a huge spectrum of -- in fact, what they were 23 using at the time was something which we haven't even 24 talked about here.

25 MEMBER GRAHAM: But it wasn't some real low, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j 1323 RHODE ISLAND AVE., N.W. l (202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433 )

l

1 395 I 1 low, low dose -- 1 2 DR. ALAZRAKI: No.

3 MEMBER GRAHAM: -- permanent stent? Okay.

4 Well, first off, put in perspective, as a management 5 person in health care concerned with tr ying to control 6 costs for what is still the largest single source of 7 mortality in the United States and which therefore is the 1

8 largest single piece of the business of health care if you 9 want to talk about it, which is cardiology, you could run 10 a 200 bed cardiology hospital by definition, and for the 11 greatest efficiency and the greateot quality of care to  !

l 12 the community, there would be no oncology delivered at 13 that site.

ip~s)

\~./ 14 There would be no radiation oncologists. You 1

15 could have some extremely qualified, well trained staff; .

16 and from what I'm hearing -- and I tried to go through the q 17 five questions - 1 ended up splitting the page in half.  ;

18 One was permanent low dose, and the other side was 19 temporary HDR; some more sophisticated classification that 20- more learned members of this committee could provide; but 21 basically that on the permanent low dose side, that yes, 22 on question number one, the NRC would alter it so that 23 cardiologists indeed, under the right set of conditions,  !

24 potentially could implant these things.

()

O 25 On the left-hand side for temporary or higher j NEAL R. GROSS  !

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

396 1

dose that no, I would concur that there's a team approach.

2 There would have to be an authorized user who clearly f, 3 understood all of the issues related by definition to that 4 high dose. Question number two, for the permanent low 5 dose, I'd again say yes.

6 By amending the regulations, they've covered a 7 very specific small set of risks and issues. I don't know 1

8 that there's major change that would occur in the regs. as i l

l 9 it applies to high dose. Question number three, for the j 10 permanent low dose, it would be yes; they would require l l

11 less training from everything I'm hearing. l 1

12 They would still require training. And I I 13 think we have to candidly discuss the concept that there 14 would be a level of training and a curriculum that could 9l l 15 be put together for board certified cardiologists that 16 would give them enough informed background so that they 17 could safely handle these one microcurie permanent 18 implants that I'm hearing about.

19 Question four, I would think, becomes no for 20 the permanent implant side because, from the feedback I'm 21 getting, these things are designed that there is some 22 degradation that would occur. And I had a question mark 23 over on the high risk side. I don't understand that you 24 would ever have intentional degradation of something that 25 would be high risk. I'm assuming that.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE BRAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 19005 3701 (202) 234-4433

..=3 397 1 Question number five would be no, or that

('~') 2 they're clearly limited. Again, I'm saying no on the low

\ ,)

i 3

risk permanent implant side, yes on the high risk -- high '

4 dose side. The majority of these stents are going to be l 1

5 implanted in a cardiac cath lab which is secured and they 6 are protected radiographic rooms.

l 1

+

7 These are folks that are dealing with 8 radiation every day when they're doing their bread and .

I 9 butter cardiac cath work. So, it's not like they're "

10 complete babes in the woods.

11 CHAIRMAN STITT: Let's hear from the FDA 12 because these issues have come before them. Both -- could t

,,, 13 you make comments regarding the use of external beam while

/ \

is ,/

m 14 you're at it for treatment of cardiovascular disease or 15 coronary artery disease?

16 MEMBER KANG: As far as I know about these 17 device, I actually am not familiar with these device where 18 our division is not involved in this. But as far as this 19 intravascular brachytherapy wise, still we are not sure, 20 as the presenter mentioned, that those is currently under 21 investigation.

22 Maybe one microcurie or maybe it's up to --

23 mentioned that 20 microcuries.

24 MR. SMITH: Yes, I believe in the IDE they're fNd 25 going to start out at one microcurie and work their way up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLANO AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006-3701 (202) 2344433

l 398 l

1 to 20.

I 2 MEMBER KANG: I think they are trying to gauge 3 the finer dosage, how much dose is going to be applicable l 4 to the human procedure. But in that regard, still the

]

I 5 radiation safety wise, we are not certain that -- how we

)

4 6 deal with the radiation safety issue. And the answer to 7 this question one, two, three, four -- I'm not actually --

8 the first question, I have no comment on that because, as 9 far as I'm concerned, the procedure itself is just a 10 stenting.

11 Radiation-wise, only involved the stent is --

12 I understand coated with the P-32, either one microcurie 13 or whatever the dose is. But still, I believe the -- if 14 the cardiologists are alone doing the procedure, should be 15 able to understand what is basic principle of the 16 radiation safety.

17 But I principally, right now, is that I think 18 the procedure has to be done cardiology with the licensee 19 -- authorized licensee stand by for the radiation safety 20- wise. But I feel that in the future, I believe there is a 21 lot of cardiologists going to be interested in themselves. l 22 So, I cannot answer for that question.

23 MR. SMITH: I wanted to point out though that 24 not all of the approaches are going to be using a stent. j 25 I mean, some of them will be using sources. They'll do a f

NEAL R. GROSS COURT REPORTERS AND TR44SCR18ERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234-4433 WASHNGTON, D.C. 20005-3701 (202) 2M l

[

399 1 balloon angioplasty, and then they'll go in and irradiate

' l,~m) 2 the tissue. They may or may not put a stent in.

V 3 CHAIRMAN STITT: We need to continue our 4 discussion, but we ought to wrap up within the next ten 5 minutes if people are able to do that.

6 Jeff?

7 MEMBER WILLIAMSON: Yes, I would like to 8 direct one comment to question number one. I think it is

! 9 a really important question. I think as the -- just 10 looking at your own medical practice statement, the answer 11 to that -- not question one. The question was raised are 12 training and experience requirements driven only by safety

.s 13 to the public and staff considerations, or are they driven

%/ 14 by issues of quality care to patients? )

15 I think that is a basic issue that's been f 16 raised. The Medical Policy Statement, as written now, and 17 as we've suggested in amending, clearly suggests that in 18 the regulations under certain -- for high risk procedures 19 -- you know, patient care considerations are involved as 20 one of the bases for putting a regulation on the books.

21 And you know, I would think just looking at it 22 globally, one of the most significant enhancements to 23 quality of patient treatment that can be made is to, you 24 know, define bottom line credentials. So I think it's C 25 sort of important even in the version of the stripped down

(

NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234M33 WASHINGTON D.C, 20006 3701 (202) 234 4433

400 1

regulations proposed by the Society of Nuclear Medicine 2

board certification for use of those diagnostic agents 3 remained.

4 And I would imagine for high risk procedures 5

that we've been talking about, some appropriate types of 6 board certification or radiation oncologists and 7 physicists would remain. I think the debate centers right 8

now on whether this particular class of permanently .

9 implanted stents is going to turn out to be a low risk -'

10 ie., a relatively technically uncomplicated treatment with 11 few chances of errors, both technical and in terms of 12 clinical assessment, such as Dr. Flynn has mentioned; or 13 is it going to be higher risk.

14 And it's a little hard to call it, I think, in 15 my opinion. But I definitely say we should think 16 carefully about what is involved as the basis for training 17 and experience requirements.

l 18 CHAIRMAN STITT: Jill had a comment. l l

l 19 MS. LIPOTI: I am familiar with a study that 20 was done at the Center For Devices and Radiological Health 21 regarding skin burns on patients that were involved in a 22 cardiac catheterization. And due to the length of time l 23 that the fluoroscope was used and some idea of educating 24 cardiologists, to perhaps look at the back of the patient 25 when they are doing a follow up examination to check for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVEL. N.W.

(202) 236 4433 WASHINGTON. D.C. 200(53701 (202) 234 4433

_ _ . . . a 1 401 1 skin burns.

[ Now, it concerns me -- and I do wish a V) 2 3 cardiologist was here to discuss their 4 training / experience. But if they have to be admonished to 5 look at the back of the patient as well as the front, I am '

1 6 concerned about their knowledge of radiation principles.

7 And I think we have to be very careful about extending the l

8 authorized user category to cardiologists because they 1

9 don't seem to have an appreciation of the radiation 10 effects.

11 CHAIRMAN STITT: That's Lou Wagner's area of 12 research -- one of his areas. Can you make a comment

-s 13 about that, Lou?

\ 14 MEMBER WAGNER: Well, the events that Jill's 15 referring to are well docnmented now. And yes, there has 16 been a recognition that many of the skin burns that have 17 occurred to patients during these long fluoroscopic 18 procedures are a result of lack'of knowledge about the 19 amount of radiation they were delivering to patients 20 during the procedures.

21 But I think -- and I agree with the comment 22 that we have to make sure that the people who are using 23 these devices are well educated. I don't think the i

24 comments that are made here around the table would want to 25 exclude anyone from doing these procedures as long as they NEAL R. GROSS COURT REPORTERS AND 1RANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

402 1 have the proper training.

i 2 Everybody here agrees that there is a certain f

3 level of proper training. That is not define at this time i 4 because of the -- because of how new the procedures are.

5 That has to be investigated. And I think initially it is j 6 appropriate that a conservative approach to the handling 1

7 and manipulation of these devices be applied until such ,

1 8 tim as we can refine our knowledge in regard to the types i l

9 of training and experience and qualifications an 10 individual will need in order to properly and safety l 11 perform these procedures both for the personnel involved 12 as well as for the patient.

1 13 CHAIRMAN STITT: Larry Camper.

14 MR. CAMPER: Two things. One is just to l 15 assist the committee in its considerations. You'll find f l

16 the current training and experience requirements for j 17 brachytherapy source use in 35.940. It contains certain j 18 certifications, which is unlikely that a cardiologist 19 would have, of course; things such as radiology and 20 therapy and so forth.

1 21 There is an "or" proviso there, just as there 22 is in the diagnostic arena today. The "or", certainly as 23 I read it contained in items B and C -- I think it's 24 unlikely that a cardiologist would be able to achieve 25 those things because it requires an active involvement and h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

1 403 1 active practice to therapy radiology and this has certain I

./T

( /

2 classroom training and experience consisting of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />

%J 3 of didactic types of training, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised l

4 experience, and three years of supervised clinical 5 experience.

6 It includes one year at a formal training 7 program approved by the residency review committee, so 8 forth and so on. Now, clearly -- my point is clearly the

] 9 oncologic uses of the sources have, for some time now, t

4 10 required a rigorous training and experience regiment. And 11 with that in mind, at least what I've heard thus far, is 12 that there is not a preference being expressed for

. 13 deviating from that training -- level of training and ge^s 4

1

\s-) 14 experience.

15 on the other. hand, what I've heard is that s

16 there are multiple modalities varying in activity levels 17 that may or may not warrant the same level of training and

. 18 experience.

I 19 Now, with having said that, we do have the l 20 good fortune to have with us a cardiologist, Dr. Manual

$ 21 Cerqueira, who can comment on this for us and has asked if 22 he can make a brief comment.

I 23 MR. CERQUEIRA: Yes; besides being a 24 cardiologist, I am also a board certified nuclear medicine f'

25 physician. So -- and I'm here not as a representative of

.(

i NEAL R. GROSS d COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 2000H701 (202) 2344433

.. . 4 3

404 l 1 the ACC, but having had discussed some of these issues 2 with cardiologists, with Spencer King, as well as some of 3 the other people that are very active in this research, 4

this is a very evolving field that we as cardiologists do 5 not know which of these various techniques will work.

6 The intent is not to basically have 7 cardiologists do this alone, but to work with people that 8 are knowledgeable about the types of radiation that can be 9

used and the doses that will be administered to the 10 patients. And I think we really need to look at this as 11 an evolving field and to try to make some decisions about 12 the training requirements so that wo don't restrict people 13 from doing low levels of radiations which are not at risk 14 to the patient or to themselves.

15 But at the same time, when we are getting into l l

16 higher levels of radiation or we are putting -- talking l I

17 about putting implantable high radiation sources, we 18 really do need the cooperation of'the radiation therapist l l

19 and people that are working in this field. I don't think 20 cardiologists are claiming to have knowledge or expertise, 21 nor do they want to basically be the sole people 22 responsible for doing this.

23 But I think it is important to work with the 24 cardiology community to develop -- to look at the existing 25 training requirements for radiologists. As was said, they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 236 4433 WASHINGTON. D.C. 20005-3701 (202) 234-4433

C 405 1 work with x-ray machinery which has the potential of

~} 2 giving patients much higher radiation than a lot of the

[D 3 other sources, so they are not naive completely in terms 4 of the radiation risk.

5 And so, this is an opportunity to develop a 6 dialogue and develop input from various people in the 7 community to look at the existing regulations and to 8 implement a safeguard for the patient as well as the '

9 people that are involved. So, I'm not her$ with, you 10 know, a definitive statement, but rather to express a 11 desire to work together on developing guidelines that will 12 be effective for all the people involved.

13 CHAIRMAN STITT: And I know we are -- well, (s_ / 14 tell us, Larry, where are we in the process of getting our 15 cardiologist replaced? i i

16 MR. CAMPER: Well, Dr. Berman of course had to 17 resign. We now are starting the process to -- we have to 18 go to the Commission and inform them that this has 19 happened. We've done that. The Commission will okay the 20 movement to announce and solicit nominations which will 21 take place.

22 I would expect that we would have an FRN 23 soliciting nominations within the next 60 days -- on the 24 order of that time frame.

25

'(C)\ CHAIRMAN STITT: So we will have -- I know we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

. ..-a l

l 406 l 1 tried to -- well, we have had a colleague join us, and i i

2 that the staff really tried to work on that. I believe f

3 they're meeting down at the hotel that a bunch of us a - l l

4 staying at, as well as New Orleans.

5 Any other comments on this topic? This is not l 6 the first time that this has come up. It's not the last 7 l time it will come up.

l 1

8 Judith?

9 Well, I'm glad the cardiologist MEMBER BROWN:

10 joined us, and I have a question. If I, or someone in my 11 family, were a patient, I would love to go to you; and I'm i

12 going to ask for your card later. However, not knowing 13 even where you come from, I'm restricted to the doctors in i

14 my area and those that are -- you know, .that I'm referred 15 to in this crisis time.

16 And I, in my own experience with the health 17 care field, have run into many arrogant doctors who, you 18 know, think no, no, no, you know, it's okay, everything's 19 fine. And I'm worried that someone who is on the bell

\

20 shaped curve on the arrogant side is going to be treating i I

21 me and say no, no, I now everything; you don't have to l 22 worry about this.

23 And I want to know that if there are risks, l 24 that someone has said no, this guy, no matter what he 25 thinks he can do, is not allowed to use this particular NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 2344433

e 407 1 treatment. And I wonder how we can achieve that because,

/~'N 2 although everyone around this table is very reasonable'and

O 3 rational, everyone outside is not.

t 4 And if you could address that for me, how we

, 5 catch those people who just, you know, want to do

, 6 everything, that would be helpful for me.

7 MR. CERQUEIRA: Well, I think those are very )

! 8 good points. And I think we should outlaw arrogance as a I 9 first step, but -- j l

10 (Laughter.)

l 11 No, realistically, the ACC is very interested i i i' 12 in helping to develop guidelines 'that will allow only

,1 r

13 certain people who have received the appropriate training

-t i\ 14 to perform these procedures. And currently, you know, 3

15 hospitals have credentialing processes for cardiologists 16 who do catheterizations and are familiar -- would be the j 17 people who would be using radiation as part of cardiology

, 18 and would also have to meet certain training requirements.

4 19 And again, the plan is not -- again, we can't 20 talk about a plan because we don't know what form is going f 21 to best be useful'for the patients. But the 4

22 recommendation would be to set definite' requirements and 23 informed consent for patients regarding the amounts of i 24 radiation.

25 It is an evolving field, and I don't think we i

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000M701 (202) 2344433 e

408 1 can be definitive; but rather try to cooperate and work l

2 together to develop common guidelines.

3 CHAIRMAN STITT: Thank you, Judith, for being 4 there when we need you. And I think we will be needing to l I

1 5 work on this together, as we have other modalities that '

l 6 we've seen in the past. And we need to wrap it up, so I'm l 7 going to keep moving on in spite of the fact that my 8 colleagues have their hands in the air. -

9 We are going to hear from Cynthia Jones I 10 discussing security and control issues of byproduct i 11 materials in medical and university settings.

12 MR. CAMPER: Before we -- clearly we'll be 13 getting with the committee again on this issue. We just l 14 wanted to try to at least get some preliminary thoughts.

15 As this continues to evolves, we'll explore it again I'm 16 sure in painstaking detail, i

17 MS. JONES: Good morning. Can you hear this?

18 Would you all like to stretch and get up for one minute?

19 CHAIRMAN STITT: If we do, they won't come l

20 back.

l 21 MS. JONES: Yes, I was afraid of that. j 22 CHAIRMAN STITT: They'll stretch and --

23 MS. JONES: Well, at least you can stand up.

24 CHAIRMAN STITT: Best to keep going.

25 MS. JONES: Well it's wonderful to be back NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

I ,- 409 ,

I with you. Welcome back to the metropolitan D.C. area.

4 2 Again, we are discussing some issues that were an outcome l

i-3 of the IIT or incident investigation team event last~ year I  :

4 which was the result of this NUREG-1535 regarding MIT; and

!. 5 as well, some staff action items which came as a result of 1 i

j 6 an augmented. inspection team which was regarding the  ;

f-7 National Institutes of Health.

.]

8 one of the things that you received in your .

l l

9 package was just an issue or a summary page regarding why

.10 I'm here to discuss some issues with you and to get your i

11 feedback, because it is very valuable feedback for both 12 the staff and the Commission to look at and digest as we 13 go forward with a new policy or proposed policy on  ;

i

\ 14 security and control.

15 As I mentioned, these.two incidents requested 16 that the staff go forward and look at an action item 17 regarding security and control. And as part of this-18 action, before we had any. guidance to the staff or to 19 licLuees on this issue, we did -- actually, I did an 20 historical analysis of Part 20, and we'll go through that 21 this morning; as well as have a number of workshops.

22 One was sponsored by the Howard Hughes Medical

.23 Institute on June 21, 1996. That involved a number of 24 radiation safety officers from the northeast and from g 25 across the country, as well as three individuals from the NEAL R. GROSS count nepOntsas AND TRANSCREGtS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2M

+.-- m 410 ,

1 1 NRC. And we had a Region I licensee workshop on August 2 21st which was co-sponsored by Region I and Harvard 3 University to specifically address the issues of security )

4 and control.

5 one thing I want to keep in mind to bring you 6 up to speed is that the overwhelming message from the 7 licensee community is that although many private research 8 and developmental research activities can comply with 9 strict implementation of the regulations in 20.1801 and 10 102, there are a number of other types of facilities like 11 broad scope medical and academic that are having great 12 difficulty in doing so.

13 So, let me go quickly through the history and 14 share with you what we found when we went through the 1

15 regulations. Back in 1957, Part 20 was three pages in the j 16 Federal Register, and that included Appendix B. So I 1

17 didn't bring my copy of Part 20 today, but as you can see, 18 it's grown rapidly from three pages to many, many pages.

19 And back then, we just had a very simple 20- statement regarding security and control of radioactive 21 material.

22 Let me move this to the other side since I'll 23 be talking on this side.

24 Licensed materials stored in the unrestricted 25 area were to be secured against unauthorized removal in a h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLA!40 AVE.. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

.~

_l l

411 1 place of storage -- very simple. And in 1964, there were

[~ \ 2 exemptions for package that were being shipped. This

()

3 resulted from a number of universities and small 4 manufacturing firms at the time that said you know, we 5 have these instances where we'd like to ship materials 6 that were packaged for shipment.

7 In many cases, they were survey instruments 8 that carried a calibrated source, a very small check 9 source. And this regulation said that when they're 1

10 attended by an individual who takes the necessary 11 precautions to prevent the exposure by a radiation or 12 radioactive materials in excess of the regulatory limits.

3 13 There was this one exemption that was filed.

t

\~-) 14 However, when we had more licensees get into the business 15 and we had a numbe.r of manufacturing firms say you know, 16 we have these check sources, we want to not be able to 17 have t his constant surveillance over it; is there a 18 possibility that we can go ahead and just have this check j 19 source with the instrument itself?

20 And the regulation at the time was changed 21 immediately because the Commission was concerned from the 22 responses we got from a Federal Register notice at that 23 time that licensees did not understand that proper 24 controls were to be maintained over the material at all

,,-~~ .

(N 25 times. It was felt --

the Commission felt at that time J

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVEL. N.W.

, (202) 234 4433 WASHINGTON. D.C. 2000 5 3701 (202) 234 4433 i

+1\

m I 412 1 that it was a little vague, and so it was strengthened.

2 An immediately effective rule meant no comment 3 period and the Commission felt very strongly that it  !

4 needed to be strengthened. So this section on item B was 5 added, which is licensed materials in an unrestricted 6 areas and not in storage shall be tended under the 7 constant surveillance and immediate control of the i 1

8 licensee. .

9 Those words, "under constant surveillance an'd 10 immediate control," is what. brings us to a number of the 11 concerns that were raised in the events of last year.

12 In 1986, the proposed regulations were sent up I 13 for Part 20, and they looked very similar to the words i 14 that we have today. They are 201.1801 and 1802. And what 15 it has is that licensees shall secure radioactive material 16 stored in controlled or unrestricted area from authorized 17 access.

18 And again, maintain constant surveillance. As 19 the incident at MIT pointed out, there was a statements of 20 consideration which is the comments that are a result for 21 any rule making with Part 20. And in 1991, there was an 22 issue raised by a research university which discussed the 23 concern that these security requirements provided 24 unnecessary restrictions on research.

25 This is a very familiar phrase that we've NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHOOE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON. D.C. 20006-3701 (202) 234A33

413 1 heard ovar tha lest year and a half or.two years.

2

/ However, the Commission at this time felt.that locking 3 radiotracer laboratories when they're not being used was a 4 small nuisance compared to the consequences of 5

unauthorized access to or theft of radioactive materials.

6 So there was, at that time, an awareness of 7 the Commission that these were relatively small qualities; 8 nevertheless, they felt very uncomfortable with making the 9 regulations less controlled.

10 So from what we found in the past, at least of 11 the history of the regulations, from 1957 to the present, 12 there appears to be an intent from the Commission to 13 secure all quantities, no matter how small of radioactive

(

( ) 14 material at licensee facilities.

15 And recent inspections that we've had within 16 the last year and a half since these events have shown 17 that security and control of radioactive materials were 18 weak in that they have some controls, but not all the 19 time; and I'll go over some instances of that.

20 Part of the difficulty -- and this is, of 21 course, is that there was conflicting guidance. As was 22 pointed out the last' time I got with you, in the NUREG-23 1535, there is a section in here which discusses the 24 conflicting guidance that was issued from the questions g'*gi .

25 and answers in Part 20.

O NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234A433 WASHINGTON, D.C. 20015 3701 (202) 234-4433

414 1

Thora waro intended as guidanco documents for 2

the NRC to give to licensees on how they could comply with 3 the new Part 20. And there was a question in there that 4

indicated that for security and control of byproduct 5

material in quantities less than Appendix C, there was no 6

naed to regulate or to secure because the guidance from 7 the NRC at the time said that those quantities were 8 exempt.

9 It's true that they're exempt from labeling; 10 but it appears that by reviewing the regulations, they are 11 not exempt from control. So some of the things that we're 12 looking at and we did look at at the workshops that were 13 held and we'll be looking at to you for additional 14 guidance and comment are what if we were to include 15 certain questions in an inspection or factor in different 16 items such as does the licensee have an audit program.

17 If they do, do they find their own security 18 and control violations; and what kind of credit should we {

l 19 give the licensee for that? Does the licensee have a 20 correct training program? Are the authorized users 21 knowledgeable about security control?

22 If not, then it could be a programmatic --

23 weakness in the program. How many labs does the inspector 24 review? There is a concern regarding large institutions 25 that have thousands of laboratories versus small h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

415 1 institutions thnt have cavorcl, tan or 20.

f-w 2 Should they be held to the same standard?

I If

\- / 3 an inspector finds that a large institution has, say, 4 2,000 iaboratories and the inspectors surveys 200 5 laboratories and finds five out of compliance, is that a 6 threshold that can be acceptable to the NRC? Is it in the 7 noise area? Or is it unacceptable?

8 Is there some threshold regarding the number 9 of labs and labs tha't we do inspect?

10 The other thing that we're thinking about is 11 where was the unsecured radioactive material found. Was 12 it in a restricted area? Was it in a posted area? Was it 4 1

/"'N.

13 in an unrestricted area? Or as we said at one of the

_, ) 14 workshops, was it found on the green grass in the middle I

15 of the quad at the university? l l

16 Was it a wasto container? Is it unlabeled?

17 These are all factors that we're thinking'of putting into 1 18 an enforcement policy to make it clear for security and 19 control. And the biggest issue which we'll need your help 20 on which I'll get to on the questions that we have for you 21 is, is there some threshold, if you will, of radioactive 22 material, that we can say below which, it does not need to 23 be controlled in a manner that means always in attendance 24 by an individual.

O l

V) 25 It's been proposed by some licensees that it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

416 1 b2 n multiple of App:ndix c. We've alco looked at a 2 multiple of ALI in Appendix B. And just to give you an 3

idea, the ALI in Appendix B are roughly five rem per year.

4 Appendix C quantities give you about 500 millirem per year 5 if you were to ingest or inhale it.

6 So -- but we recognize that, you know, there l 7 are not quantities where people readily have access to 8 probably eat it. We're talking about risk based 9 regulation. So what's the probability that someone would 10 have a chance of eating this if they happened to get in 11 your lab when you were out and so forth?

12 One consensus from the' workshops are clearly l

13 that we understand both with the licensees, and licensees 14 agree that if it's a stock solution, if it's a very large Gl 15 quantity of material, it should be secured and locked.

16 Everyone could agree on that. Everyone.could agree that 17 for the very low levels like Appendix C, if you have a 18 regulation that says it's not needed to be labeled, then 19 you shouldn't have to worry about it.

20 But it's this middle area that we need some 21 assistance in. And then how would you address waste if it 22 was in those quantities -- should it be in the same kind 23 of area. So what we're doing are evaluating the existing 24 regulations. We will be proposing a policy to the 25 Commission.for either changes to the regulations or h

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 2000k3701 (202) 234-4433

417' 1 changco to tha enforcemtnt policy for escurity and control  !

<--( 2 of radioactive materials. l

'(

'\~/

\

3 A "one size fits all" approach may not be 4 beneficial for both reactors, large broad scope 5 institutions, and small licensees. Right now we have a 6 "one size fits all" approach. And we're gathering 7 information, as I mentioned before, from workshops and l

8 from advisory committees such as yourself. '

9 So these are some of the questions that'we j 10 would appreciate your input on. And I might add that it's l i

11 always beneficial to us when we're preparing a Commission 12 paper that it's not the voice of the NRC staff, it's the l 13 voice of, in this case, many individuals from licensee

(_,j 14 institutions -- members of the public were invited to I 15 these workshops; health physics consultants were at these 16 workshops; and your advise as well.

17 So we fjet many different kinds of voices and 18 opinion before it actually goes out for a public comment 19 period when we put together the paper.

20 So question number one: are there any 21 materials that require no security control or are 22 adequately controlled by the normal laboratory 23 environment; and if so, what quantity should they be?

24 Yes?

O i

! 25 MEMBER WAGNER: Don't you already have such a d

NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

~

l 418 1 definition of thoca things? You hava certain quantities 2 that are defined as -- gosh, I can't remember what --

l 3 they're below regulatory concern, very small quantities of 4 material.

5 MS. JONES: We don't have below regulatory 6 concern policy.

7 MEMBER WAGNER: I know that, but --

8 MS. JONES: The only thing we have is Appendix 9 C, which is a quantity that does not require labeling.

10 But that does -- we do not have a policy that says 11 something below this level, you don't have to secure.

12 MEMBER WAGNER: There are materials that 13 individuals can own that are below certain levels and 14 defined in terms of certain quantities.

15 MR. CAMPER: They're exempt quantities.

16 MEMBER WAGNER: ' Exempt quantities. That's 17 what I'm thinking of.

18 MR. CAMPER: But they're never exempt once 19 licensed. They don't become exempt because they decay.

20 MEMBER WAGNER: That's what I'm saying here 21 though. You have exempt quantities. And presumably, 22 certain quantities might be applied under item number one.

23 I mean, that defines certain levels, for example. That's 24 already a starting point. That was my point, and I think 25 that's appropriate. j i

NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS l

1323 RHOOE ISLAND AVE., N.W. j (202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433 i l

419 l

1 CHAIRMAN STITT: Okay: Jeff?

f-~ 2 MEMBER WILLIAMSON:

,( It sounds like you have

\- 3 sort of three sets of levels you could choose from. You 4 have the Appendix A which defines the cut off below which l

.l i 5 you don't have to label things; you have a level of i

6 2xemption which exists outside the licensing proc ~ess; and 7 then you have sort of a level -- what was the third one l

8 you mentioned that resulted in exposures of five rem if i l

9 you eat it? ,

i 10 MS. JONES: That's the ALI.

11 MEMBER WILLIAMSON: The ALI. So your question 12 is, which of those -- I guess for simplicity, it sure 13 would be nice if you could pick one level where kind of O

\

t y_/ 14 all these things came together below which there was no 15 regulatory concern, labeling, control, inventory -- it's  !

16 just -- <

I 17 MS. JONES: Yes, we've meant --

I stuck with 18 Appendix C limits only because that is a quantity that's 19 easily defined in the table in Part'20. Appendix C 20 quantities were derived by taking the lowest ALI in 21 Appendix B, rounding it off to the nearest tenth, and 22 that's the value for Appendix C.

23 So all the Appendix C values come from the 24 ALI's, but it's rounding errors up or down because they're (mj 25 even multiples of ten.

4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVEL. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

• l 420 1 CHAIRMAN STITT: Comm:nts from Dan Flynn?

l 2 MEMBER FLYNN: I think you have to be careful j

3 not to create a potential bureaucratic nightmare in terms 4 of, for example, the people who work in the research labs 5 may get a certain amount of basic training. And then 1

6 they're used to doing certain procedures certain ways. '

7 Now, a research lab one year may use a very small quantity 8 of tritium, let's say.

9 9

And then they have a new investigative project 10 where they're now using a higher quantity of something 11 else like P-32. If you -- in some ways, a "one size fits 12 all" in some ways is helpful because the workers in that 13 lab are concentrating on the research, not on the 14 radiation.

15 So they're used to doing certain procedures 16 certain ways. The lab has a lock on it or it doesn't have 17 a lock on it. I mean, you have to understand that the i labs are going to be changing.

1 18 One year they're doing i

19 something; the next year, they're doing something else.

20 And to be constantly changing what category your lab falls 21 in and what kind of training you have to have or what kind 22 of security procedure you have to have when their main 23 focus is the research, not the radiation, can create 24 problems.

25 MS. JONES: Yes, the difficulty with the h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

1 421 1 cituation co wa ceo it when wo go out and inspect are we 2 have laboratories that are very similar to our offices

. /n D) 3 upstairs. They're open air laba, or else there's 20 or 30 '

i 4 different laboratories that are connecting.

5 And even if you're in one part of the i I

6 laboratory, you cannot physically see -- you don't have a 7 line of sight which our enforcement people have 8 traditionally said is constant attendance, a line of '

lj 9 sight. So their concern with us is we can't have someone 10 in the laboratory that can actually see at the other'end 11 because it's just a maze of labs.

i 12 So, --

l 13 MEMB2R WILLIAMSON: What do you do? Do you fm

( 14 require it to be locked up then? <

15 MS. JONES: Yes.

i 16 MEMBER WILLIAMSON: That's the alternative?

17 MS. JONES: It's either locked or it's in 18 constant surveillance, and that's the problem that the l 19 community has raised, and it is a concern. It's very 20 difficult.

• l 21 Yes, Dr. Graham.

l 22 CHAIRMAN STITT: Go ahead. We're doing our 23 little business on the side. I'll get with you in a 24 minute though. ..

(m

\

) 25 MEMBER GRAHAM: Given the discussion of the NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVEL, N.W.

(202) 234 4 433 WASHINGTON, D.C. 200 5 3701 (202) 234 4 433

422 1 1cet two dcya, I think this in the firct concrete iccua 2 thic committee's going to talk about after the debate over 3

the motion, where the rubber hits the road, and this group 4

has to start to define risk on a cost benefit basis.

5 I can only deal with the environment in which 6 I work where we have dozens of buildings and dozens of 7 research labs, and they have everything from, I'm sure, 1

8 incredibly low doses being used in some rat experiment to 9 high dose radiation being delivered with very significant 10 potential risk to the public.

11 This group -- and to me, it seems that there l

12 has to be a way that this group can articulate scientific 13 parameters that would allow for security where there's a 14 clear and frank danger to the public, but where we can get .

15 out of an inspector legitimately following the rules who 16 walks in and says oh, you've got that sitting on a 17 counter, and it's the other side of the wall, and you 18 can't see it, and he's buried 200 yards back on some lab 19 that nobody goes into.

20 And where -- as some of the comments said, what we're currently trying to do is enforce security 21 22 issues where there's an extremely low risk -- and there's 23 only so much time you can focus an organization on this.

24 I would much rather have my people focused on 25 exactly how we control high dose radiation brachy sources, NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 53701 (202) 234-4433

423 1

cnd I could focus th:m very clearly on that if thoy'ra not 2

I 1

all spending months figuring out how we lock up this one

\s ,/ 3 room when John walks down the hall because he's got an 4

instrument in the next room; and yet, if we had inspected 5 during that ten minutes, he's going to get gigged.

6 So, there's a test of reasonableness that I 7

think we're being asked to scientifically identify. So 8 I'll raise that question to the technical members.

9 CHAIRMAN STITT: I want to just point out that 10 in your packet, the members of the committee have a 11 statement from the NIH radionuclide security working group 12 which was sent to the ACMUI. And I presume it expresses 13 the sentiment of that group as a whole and does comment'on (N 14 --

w 15 MS. JONES: What was the date on that?

16 CHAIRMAN STITT:- It says, "I hope your 17 committee, in its deliberations on this issue, will 18 consider cost, both tangible and intangible, of the 19 current 'zero tolerance' approach of the NRC."

20 MS. JONES: What is the date on that?

21 CHAIRMAN STITT: The cover letter to me is i

22 November 8th, and I don't know if you have the cover 23 letter on it or not.

24 MS. JONES: I have not seen that. We can't 25 find what you're talking about.

\/

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

424 1

MS. MERCHANT: Torroc[yathat it's a handout.

2 It was one of the handouts, so it won't be under a tab.

3 MR. CAMPER: This was provided to -- it's 4

actually addressed to Dr. Stitt for awareness about the 5 committee. Cyndy's pointing out the agency is not --

6 we've not had a chance to react to this yet. -

7 MEMBER WAGNER: I don't know where it is.

8 When was it handed out, Sally? Was it handed out today, '

9 yesterday, or was it mailed to us, or what?

10 CHAIRMAN STITT: I got it as a fax, so I' don't 11 know -- that's why I had asked if the committee had 12 received it.

13 MEMBER WAGNER: I don't remember seeing it.

14 CHAIRMAN STITT: Okay.

15 MEMBER WILLIAMSON: An ACURI position 16 statement on radioactive materials security.

17 MS. JONES: That's ACURI. It probably is not i

i 18 three whole punched is what I'm hearing from Torre. Torre 19 is going to make some copies. So if you'd like to just go 20 ahead and tell us what it says. l 21 CHAIRMAN STITT: Let me find a place where I 1 22 can just summarize. Well, it says the scientific 23 community at NIH has taken steps to address the NRC 24 concerns and NIH research lab needs. The community aims 25 to make sure that radionuclides are effectively guarded, NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE IStAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4 433

425 1

whilo allowing raccerch to b2 conducted efficiently and f-~ 2 safely.

(\ ,

3 The working group wishes to express its- i l

a 4

concern about the NRC's "zero tolerance" radionuclide 5 security policy to us, the Advisory Committee of Medical 1

6 Uses of Isotopes. And then in summary, we strongly I 7

, believe that one should reconsider the current NRC i 8 security policy to take into account its risk benefit

, 9 ratio and reasonableness.

10 To facilitate research and to reduce the i

i 11 possibility of contamination and safety risks to i

i 12 researchers, we believe exemptions'should be made to the  ;

13 current locked door policy when low levels of radioactive 14 materials such as the few times Appendix C level are used.

15 And it refers to Appendix C, levels that do 16 not require posting the caution signs according to 10 CFR 4

17 20.1902. In addition, excluding unsecured source vials -- i 4

la it is unreasonable to -- okay,'in' addition, excluding 4.

19 unsecured source vials, it is unreasonable to require 20 locking doors to rooms that house dry radioactive waste, 21 liquid radioactive waste that contains very diluted

[ 22 materials, columns that contain either trace amounts of 23 radioactive materials, or radioactive compounds covalently 4

24 linked to the solid matrix or instruments for monitoring G

25 radioactivity.

) .

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433 i

426 1

In ccernca, while it ia cacential to lock up 2 the source vials, it is unnecessary and counter productive 3 to require locking doors for samples with low levels of 4

radioactive materials and low levels of solid waste and 5 into highly diluted liquid waste.

6 So that's their commentary from NIH.

7 MEMBER BROWN: Judy, you said that's a working 8 group -- that's an internal NIH thing? Because it seems 9 like they're just responding to the fine they got. I have 10 the article here that they have been fined $2,500. And it 11 says NIH plans to respond to NRC, so maybe they're trying 12 to involve the ACMUI in that; and it's really going to the 13 court at this point, it seems.

14 Maybe --

15 CHAIRMAN STITT: They call themselves a 16 subcommittee of the NIH radiation safety committee formed 17 by Michael Gottesman, G-o-t-t-e-s-m-a-n, NIH Deputy 18 Director for Intramural Research.

19 MS. JONES: .Dr. Gottesman is the primary 20 correspondent on enforcement issues from NIH to NRC. And 21 it is true that we did propese a civil penalty of $2,500 22 to NIH. NIH did respond, and they did not agree with us 23 on the issues that were in the enforcement package, and 24 that is with senior management as we speak to determine 25 what next step we will take.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

427 1 CHAIRMAN STITT: The othar two physicists --

2 Jeff, and then we'll --

\

V 3 MEMBER WILLIAMSON: Well, I take it you've 4 accepted -- and you don't need to -- I think last time we 5 strongly and unanimously urged that quantities of 6

radioactivity that were below the threshold for being ,

7 labeled should not require line of sight, -- '

8 MS. JONES: Right.

9 MEMBER'WILLIAMSON: -- a visual surveillance l 10 and being locked up. You've accepted that now. So this 11 means the part of their memo that's addressing the issue 12 of waste --

13 MS. JONES: Well, waste --

A 14 MEMBER WILLIAMSON: -- and dry waste and the 15 little tiny sources that are in survey meters and what 16 not?

17 MS. JONES: Well, it's kind of a whole issue.

18 MEMBER WILLIAMSON: That's been addressed?

19 MS. JONES: We're in the process, as I 20 mentioned before, of proposing to the Commission a change 21 in policy.

22 MEMBER WILLIAMSON: I mean that you're happy 23 with the advice you've gotten on that --

24 MS. JONES: Yes.

p

( 25 MEMBER WILLIAMSON: -- class of issues?

(

NEAL R. GROSS COURT REPORTERS ANO TRANSCR18ERS 1323 RHODE ISLAND AVE., N.W.

(202) 2344 433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

~

428 ]

1 MS. JONES: And now it'a even more so is it --

2 are there materials that require no security? Your answer 3 is yes. It's Appendix C, limit the quantities. And 4 that's the quantity. t 5 MEMBER WILLIAMSON: I guess what I'm asking, 6 is there fair -- is there consensus within the agency 7 staff and the laboratory users that you've had these l

8 meetings with that that's an acceptable limit where 9 security precautions end, more or less?

10 MS. JONES: No. In some cases, at the I 1

11 workshops, they felt that it should be ten times Appendix l l

12 C or 100% Appendix C. Much higher than just the Appendix i 13 C quantity is the quantity that some licensees believe 14 should be a level below which does not have to be 9!l l

15 constantly controlled and in immediate surveillance.

16 MEMBER WILLIAMSON: Well, but let's --

17 MS. JONES: So it's a much higher limit.

18 MEMBER WILLIAMSON: Im sorry; I don't mean to 19 take so much time. I'm trying to separate things into two 20 issues. I think there are at least three categories, 21 following up on what John said. There's a category below 22 which you don't need to lock things up, you don't need to 23 watch them, zero sort of security precautions or 24 effectively zero special precautions are needed.

25 There certainly is a high risk group of stuff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

429 1-where I think most of us would agree that the currently 2 policies are applicable. Then there's a middle ground (m)

V 3 which is really sort of touchy, what are some appropriate 4

-- kind of a mediate or intermediate cost control 5 mechanisms that could be asserted, and what should be the 6 upper and lower boundaries or thresholds for that-7 category.

8 So my question to you is, have you satisfied -

9 - is there consensus as to what the first threshold', just ,

10 the sort of zero control threshold should be?

11 MS. JONES: No , there is not.

12 MEMBER WILLIAMSON: Okay.

13 MS. JONES: We have originally staff at the

/

V 14 NRC two years ago, three years ago, that worked on the j 15 guidance in the NUREG for questions and answers.-- felt l I

16 below Appendix C was the number. We've had workshops 17 since then which licensees say well, that's really a very, l

18 very small quantity, and it should be some multiple of I 19 Appendix C -- ten times or 100 times Appendix C should be 20 the quantity below which could be controlled, say, by I signage.

21 22 A sign in the room, it's in a restricted area 23 --

24 MEMBER WILLIAMSON: I'm sorry, you've missed t 25 my point. I'll repeat it.

(-

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2344433

430 1 MS. JONES: But ths point is, we do not have a 2 consensus, and that is the reason for the workshops. And 3 that is the reason for your input to us so that when we 4 write the commission paper, we can say we polled ACMUI, 5 here is their advice on thresholds for low, medium, and 6 high, which is question two.

7 MEMBER NELP: When you're referring to "C",

8 how is that expressed; is it microcuries?

9 MS. JONES: Yes.

10 CHAIRMAN STITT: Lou Wagner.

11 MEMBER WAGNER: It seems to me we're missing 12 one of the points here, and it's about security. The 13 issue is, why are you securing it? Are you securing it 14 against stupidity? Are you securing it against the fact '

15 that some unknowledgeable person might come in and 16 contaminate themselves and spread radiation all over the 17 place?

18 Or, or you securing it against sabotage or 19 maliciousness? If we're doing it against stupidity, 20 that's one thing. You don't have to find a certain level 21 of security that you've got to do this reasonable level.

22 But if you're securing it against maliciousness or 23 sabotage, that's a very difficult issue.

24 Number one, presumably maliciousness and 25 sabotage are rare events. These are very unlikely and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005 3701 (202) 2344433

431 1 rare evcnto. And if you try to make regulations to make I

es

\

2 that a zero event, you're going to be putting very strict

\-- 3 regulations on a lot of places that aren't ever going to 4 experience any of this and have pretty good controls over 5 their work force.

6 So you're going to make their life much more 7 miserable, and you're going to be affe.cting a large 8 percentage of people for a -- it may be an important, but 9 a low level amount of activity that goes on there. What I 10 mean is a low level amount of sabotage or maliciousness 11 that takes place.

12 So it's not clear to me in looking back at the 13 history of all this what the NRC had in mind, because I

/3 i +

( ,/ 14 think that's very important. And we have to look at the 15 relative risk. And part of the relative risk of these 16 events is how frequently do you expect them to occur.

17 If you're trying to secure them against 18 maliciousness, you've got a huge problem. Because the 19 people who are going to be malicious about this may 20 actually be people who are commonly around in the labs and 21 may be the very people who are surveilling (sic) this 22 stuff in the first place.

23 So it's a extremely hard to secure against 24 that kind of a thing. But if you're trying to secure

/N i 25 against stupidity or -- let's say somebody has their --

s/

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

432 1 it's a laborstory whnre you have this ona lab and thsn 2

next door there's other labs, and sometimes they bring 3 their children there and the children are running around 4 playing.maybe on the weekends or something and you want to 5 secure it against possibility that these children might 6 come in and contaminate themselves and, you know, that 7 kind of a thing, that's totally a different story and a 8 total different level of security.

9 So I'd like to have some understanding'in the 10 history of this. What are we trying to secure against?

11 MS. JONES: It's the latter of the two issues 12 that you raise. As I point out in the summary page that 13 was in your package, there's wide agreement both within 14 the NRC and within licensees at all these workshops that 15 neither the existing regulations nor the security programs 16 that licensees are directed at are likely to be effective 17 against intentional misuse of radioactive materials by an 18 authorized individual.

19 The events that we've had over the past 11 20 years, or 15 years, I think, are 11 or ten cases of 21 intentional misuse. And the one event in Canada resulted 22 in that individual going to prison for it for doing 23 something deliberately and malicious with radioactive 24 material.

25 So of all the types and hundreds of thousands f NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

433 1

of shipmrnts wa'va had in the past 15 ycars, wa know of 11

,,, 2 cases. So it's a very, very rare occurrence. So we have ms 3 the numbers, if you will, to say that is not the intent of 4 this rule.

5 Be that as it may, we need to come up with a 6 very good explanation to the Commission why, if we're 7 raising the threshold from what was -- appeared to be 8

zero, to some higher level, some words about why that 9 level is justified. Why can we say Appendix C or ten 10 times Appendix C quantities are a value below which we-11 think that the institutions can control it through 12 signage?

13 And an example that our office director uses rN

) 14 all the time by Dr. Carl Paperiello is for voltage. Ten 15 thousand volts is protected by signage. There's no one in 16 constant surveillance or constantly looking at the voltage 17 to make sure no one opens up that door. It's probably

. 18 locked; but in many cases, it's just with signage.

19 So can we do a similar thing for radioactive 20 materials?

21 CHAIRMAN STITT: Jeff -- well, no; Dennis, you 22 haven't spoken in a while. Dennis, followed by Jeff.

23 MEMBER SWANSON: I think a key to security is 24 not only signage but labeling. And I think, you know, you fq,.-

25 have labeling limits; but certainly anything above those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433 l

1

434 1 limits ought to ba labsled, wh: thor it'a tha stock 2

solution, individual syringes from a stock solution, waste 3

containers -- need to be labeled that it contains 4 radioactive material, point number one.

5 I think that's part of the security and an 6 integral part to the security. I think a second issue, if 7 we want to start talking about risk, you need to take a 8 look at -- you know, .nany of these laboratories also .

9 contain toxic chemicals, and they're not locked in the 10 storage cabinets.

11 And I would venture to say that many of them 12 are more toxic than the levels of radicactive materials 13 that you're going to encounter in the typical research 14 laboratory. So I'm not sure beyond posting that as an 15 area of radioactive material use ensuring that everything 16 that's used in there is labeled that it contains 17 radioactive materials, and ensuring that your exposure 18 limits are maintained within the appropriate limits that 19 you really need to do anything beyond that.

20 MS. JONES: Okay. One of the things -- if I 21 can just add one point where we're thinking of it -- came 22 out from the Howard Hughes Medical Institute workshop is 23 when we have cases in laboratories were material is 24 actually in use -- if it's in lab apparatus, if it's in a 25 jail, if it's in use -- so it's almost physically NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 2344433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

435

~1 impossible for you to take it away -- or if it's in a

!f-~g- 2 waste, that may be another thing that we can look at and 3

put into the policy, that it's in use, it's not going to 4 be easily taken away by someone.

, 5 It's not like a stock solution.

I 6 CHAIRMAN STITT: -Jeff and Lou.

7 MEMBER WILLIAMSON: Well, I think -- you know, a good starting point would perhaps be to, I think, have

~

8 9 three categories probably. It would seem reasonable that I 10 your Appendix A -- is that right?

l 11- MS. JONES: C.

12 MEMBER WILLIAMSON: C. Excuse me; I keep i

l 13 getting it mixed up. As well as labeling being

[,

\ 14 unnecessary, security precautions would be unnecessdry.

t.

15 And the rationale would be that these levels have been 16 precalculated to correspond to the 500 mr exposure if the -

17 worst possible thing in the world happened to them -- if 18 somebody sort of took the stuff and drank every drop of l '19 it.

1 l 20 Okay, so that's pretty reasonable and I

straightforward that it really,'from this perspective of 21 22 control and labeling and inventory, and kind of drops out 23 as being of-regulatory significance. I think probably 24 between that level and something on the order of ten times 25 the exposure -- occupational exposure and limit, which NEAL R. GROSS '

COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433 t-

436 I l

1 might ba som whara around the minimally msdically 2 detectable level of exposure, there probably should be a l 3 intermediate zone of protections that would be more 4 passive than active such as --clearly labeling and all l 5 these other things are included, but the -- you know, the 6 idea of keeping it in a controlled area, of having 7 controlled areas clearly marked with appropriate signage, j 8 but not requiring -- for example, if you have a tiny bit 9 of the sample in some sort of a, you know, lab device 10 that's doing a measurement that someone has to sit there 11 and watch it for two hours or it has to have a big lock on 12 it when it may be inappropriate for the instrument design.

13 You know, say okay, no locking and constant 14 surveillance. And perhaps above that level, whatever that 15 intermediate upper threshold level would be, to continue 16 with the existing policy as stated.

17 MS. JONES: Okay,. appreciate that.

18 CHAIRMAN STITT: Lou Wagner.

19 MEMBER WAGNER: I think it's important that we

20. recognize that the incidents that sparked a lot of this 21 discussion were malicious incidents. And that these 22 incidents indeed are controlled by regulation already.

23 And that is, if you're convicted of anything like this, 24 you're going to pay the penalty.

25 So I think there is regulation against that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 23M

437 1 and cufficient regulation, and that's how it should ba 2 covered. So now, the discussion about the storage and

'(, i

\

3 signage, etc. deals with something that's really not what 4 really sparked the discussion in the first place. It's 5 not-about those instances. l 6 It's about the general working force of a 7 university. And I think I would recommend that, indeed, 8 the Commission do a change to it's policy regarding the 9 strict enforcement of the regulations the way it is done.

10 I think there is a lot of legitimate complaint because I  !

i 11 come from a big university where we make very strong 12 efforts at maintaining security over our materials.

I i

13 We have a program that reviews that

( .

Q). 14 constantly. And we have the security officers even

]

15 discussing things with the radiation safety committee 16 regarding what they find in terms of open doors, etc.

17 within the facility.

18 So there are facilities trying to make a good 19 effort at this. But I can guarantee you there's no way to .

20 do it absolutely 100%, but it's very effective. And then 21 when you start having zero tolerance on your enforcement 22 for what are relatively minor things, that becomes a major 23 problem and a major bone of contention.

24 So I think there is a lot of legitimate reason 25 for why there should be an effort to look at those NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE., N.W.

-(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 23&4433

]

l

1 438 1 regulations and to dsfine th:m. I cannot give you the 2 numbers. It's a very difficult issue to do to give you 3 numbers between what should be signed and what shouldn't '

4 be signed.

5 That is the issue. But yes, I would encourage 6 there be a big change here, and to allow -- to get away 7 from the zero tolerance rule, because it really is not 8 cost effective; and deal more with the spirit of the rule 9 -- is this university really make the appropriate efforts ~

10 necessary in order to keep their stuff secured; or are 11 they really lax, are they really sloppy?

12 And if they're sloppy, then that's another 13 issue.

14 MS. JONES: Do you have any feel for number of 15 laboratories that is an acceptable threshold if they have 16 -- if the licensee has an audit program that is 17 acceptable? I'd just be curious in that.

18 CHAIRMAN STITT: Go ahead, Dennis.

. 19 MEMBER SWANSON: No, I think the issue is not 20 a number. I think the issue comes down to a performance based inspection rather than a prescriptive inspection, 21 22 okay. You know, are there radioactive materials generally 23 in control. I mean, it's not even generally. Are they in l

24 control? Are they in the laboratory? Are they finding 25 radioactive materials out on the lawn. lh NEJd. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

439 1

Okty, if they're finding radioactive materials

- /g 3

2 out on the lawn, you've got a problem. If they're in a

\ 3 controlled environment, you know the problem's not --

you 4 know, it's not a problem whether they're in a locked 5 cabinet. Okay, that's becoming very prescriptive. So, 6 you know, are they generally in control in that

, 7 laboratory?

And I think the answer to that is yes.

8 I

9 think most institutions, there are -- they're generally in 10 control. Now if you go in and take a prescriptive 11 approach and say well, they're not locked in a cabinet --

12 well and, you know, this person's on the outside of the f .s 13 room; well, that's fundamentally the problem.

,) 14 That's the problem the institutions have.

15 They're in control. The inspectors are taking very 16 perspective approach to regulation, and that's what you've 17 got to change.

18 MS. JONES: That's why were' talking to you, 19 and that's why we're already in the process.of proposing 20 the changes. That's --

I 21 MEMBER SWANSON: Yeah, but I don't think you - l 1

22 - you know, the point is, I don't think you make the  !

)

23 change necessarily in a regulation; it's how you enforce j l

24 the regulation.

I 25 MS. JONES: Okay, well that is a big point NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE., N.W.

(202) 23W WASHINGTON, D.C. 20005 3701 (202) 23W33

440 1

that is a diccuccion for -- that I'd lika to hear from --

2 there is a difference among the staff that perhaps it 3 should be done through regulation. The word that we got 4

from the licensee community is, you know, that takes way 5 too long; and those of us on staff that have done 6 regulation would agree it would be too long.

7 We need almost an immediate fix, if you will, 8 or a very soon fix. So, change the enforcement policy 9 first. But if we change the enforcement policy to allow 1

10 this flexibility, do you think the regulations still need 1 11 to be changed; and are they still unclear if there is a 12 change to the enforcement policy?

13 CHAIRMAN STITT: Jeff?

14 MEMBER WILLIAMSON: Well, I think they do 15 because if you just read them the way they're written, 16 they require all level.of excessive precautions to be 17 taken all the way down to zero microcuries. I mean, they 18 really do; and it really does not'make an allowance for 19 exceptions, it seems, unless you have ancillary documents 20 such as regulatory guidance documents that build that into 21 the process.

l 22 So it would seem you need a double approach 23 here to try and come up with a rational enforcement scheme i 24 to take the regulated community through the transition 25 interval while you revise the regulations to be more i

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200( 5 3701 (202) 234 4433

-. . _ ~ _ . . . _ . . _ _ . .

441 1 eppropriato.

2 CHAIRMAN STITT: John has a question.

D' 3 MEMBER GRAHAM: I'm directing this to Jeff and 4 Lou. What I'm struggling with -- I'm hearing staff say 5 that they've got a -- they're in a bind. They've got a 6 zero tolerance policy on the books that requires that 7 every room be controlled and/or that they maintain 8

constant surveillance, which literally means for any 9 amount, anywhere, any time, it either has to be line of 10 sight, or you're going to get gigged.

11 And I'm hearing everybody say that's

12 irrational. And as a lay person, I can't sit here and 13 define numerically three levels that would constitute low, f3 4

14- medium, and high risk that then could be linked with low, 15 medium, and high cost of security control.

16 Is there a -- can your professional I

, 17 organizations; can you, as a subcommittee identify what 18 those numbers would be to staff? Because that's what I'm 19 hearing they're looking.for.

20 MEMBER WILLIAMSON: I tried.

21 MEMBER GRAHAM: Well, are you conversant with 4

22 what the numbers are in Appendix C? Because I'm hearing

23 it referred to without an actual number, and I'm 24 struggling with the fact that --

m 25 MS. JONES:

, (v) They're very low quantities. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

4 442 l 1 l .can, thcy're extrcmaly low.

Tritium is 1,000 2 microcuries. What's some other ones? You know, sodium-22 ,

3 is ten microcuries. They're extremely low. They're l 4 either 1,000 microcuries or less.

5 MEMBER WAGNER: In addition, I think that one 6 way to appropriately handle this is all these 7 institutions, of course, have radiation safety committees.

8 I serve on mine, and I'm sure many of the people around 9 here serve on theirs. We deal with this issue all the 10 time in the radiation safety committee.

11 And the first thing I always raise before I 12 raise the letter of the law on the zero tolerance issue is 13 I always raise the spirit of law. Are we within the 14 spirit of law? What's the spirit of law? We don't want 15 these materials to get out into hands that are 16 inappropriate to have. That's what we really don't want 17 to do.

18 So we look around at what we're doing and try 19 to mvhe sure that everything -- every activity we're doing 20 is meeting that spirit of the law. And then there's the l 21 letter of the law which is the next thing you've got to 22 try to tie up.

l 23 And I think it would be appropriate if there 1

24 was some ability of the NRC to give the radiation safety ,

25 committees at these large institutions a little more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

443 1

authority and to direct. tham they must.take the authority, j

2  !

they must take the responsibility to ensure that the_ l

'3' spirit of that law is met within their institution and 4

demonstrate.that by the activities that the radiation 5

safety committee. deliberates _on and the enforcement 1 policy 6' say they do.

7 And I think that would-be the appropriate 8

thing to look is are.these committees performing the -

9 duties they need to be performing, and are they really 10 trying to do this, and is -- and what measures have they 11 taken; have they been practical.

12. And rather than get into prescriptive things 1

A 13 like this, the university itself knows very well where its

( ,) 14. weak points are -- or should know what areas are weak 15 points and what areas are strong points; where they need 16 to put emphasis and where they don't need to put emphasis.

17 And that's the whole role of the radiation 18 safety committee at those institutions. So I would like 19 to see more authority given to them so that they can 20 define -- so you might assist them in the definitions, j 21 But I think they_have to define for their institution and  !

l 22 identify the low risk areas, the medium risk areas, and 23 the high risk areas in which they have to have different 24 levels of security.

( 25 CHAIRMAN STITT: I'm going to exert my control NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON D.C. 20006 3701 (202) 2344 433

• 444 1 hera. Wa're on a roll, and I think we're making comments 2 that are helpful. We have a member of the public who 3 wants to speak. I'm going to call for a 15 minute break.

4 We have done well this morning. We have some extra time 5 because the 11:45 to 12:45 segment is going to be 6

presented in writing -- given to us, because it's really 7 informational.

8 So we have plenty of time to complete this 9 discussion. We need at least an hour for inspectio'n 10 guidance, and it's going to be interactive with a lot of 11 commentary that needs to come from this group.

12 So,.I'd like to take a 15 minute break. We'll 13 come back with comments from a member of the public, and 14 then we will continue with our comments.and finish this l 15 topic. l 16 (Whereupon, the foregoing matter went off the 17 record at 10:39 a.m. and went back on the 18 record at 11:05 a.m.)

19 CHAIRMAN STITT: Committee, sit down. We're 20 going to work.

21 MR. ROTMAN: For the record, I'm speaking as a 22 member of the general public. My name is Mark Rotman.

23 With this issue of security, as a member of 24 the regulated community and having been at this meeting 25 yesterday, and especially yesterday morning's opening NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

445 1 remcrks, I dictinctly referred to Dr. Paperiello's 7-~ 2 discussion of diagnostic nuclear medicine as a low risk i )

3 activity, one that could essentially be deregulated.

4 And if you look at -- if you'll excuse me, I'm 5 going somewhere with this -- it does relate to security 6 directly. If you look at the final rule that was recently 7 published, at least on Part 35.75, the release of I 8 patients, which discusses allowing patients to leave 9 confinement with various levels of radioactivity in them.

10 Some of this radioactivity even could be biologically .

I 11 excreted by these patients.

12 If you look at those issues of 10 million 13 diagnostic radiopharmaceutical doses being turned loose l 4

x ,/ 14 into the public yearly, and the potential impact on l 15 dosimetry to the public from that, and you look at that 16 and then you look at what the NRC is doing with security 17 of radioactive material used in biomedical research 18 facilities, you have a gargantuan disconnect with respect 19 to protecting the public health and safety.

20- How can you be concerned about microcurie 21 amounts of carbon-14, or tritium, or P-32, that might be 22 stolen or inadvertently removed from a laboratory when on 23 a daily basis people with millicurie quantities of 24 radioactive material leave nuclear medicine departments, (nv) 25 travel on subways and in buses and on airplanes, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 23&4433

7 446 1 expo:o m;mbars of their familien, and all of these other 2 things.

3 I think until the NRC looks at the security 4 issue in a more global way and compares it with other 5 issues of public health and safety that it directly 6 regulates with respect to radioactive material, that what 7 you're talking about here for security are nuts and bolts 8 that are kind of silly. I mean, you could write a -

9 regulation or a NUREG that would be hundreds of pages long 10 trying to explain the intimacy of a security policy, 11 whether it is a sharp that has contaminated, or a gel that 12 has set, or whether it's an old chromatography column.

13 I mean, let's get real here. You've got to  !

S!

14 look more at a global issue. The amount of risk that the  :

15 public is going to receive from unsecured radioactive 16 material used in biomedical research facilities is I 17 absolutely minuscule when compared to the daily risk to 18 the public health and safety from release of patients who 19 have undergone therapeutic treatment.

20 Thank you.

21 CHAIRMAN STITT: Let's continue with comments.

22 We have questions 1 through 5. You have them in front of 23 you. Any other comments that need to be directed 24 regarding this issue?

25 Jill?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

447 1 MS. LIPOTI: One of tha questions that Cynthia f~~ 2 i

raised was whether a change in the enforcement policy

)

\s / 3 would. suffice, or whether a regulatory change was 4 necessary. A change in the enforcement policy, as I 5 understand it, would not be noticed in the Federal  ;

6 Recister, and there would be not opportunity for public 7 comment. And so I believe that you need to proceed to a 8 regulatory change, which gives the opportunity for a wider .

9 comment. -

10 MS. JONES: One of the things that we are l

i 11 planning to propose to our Office of Enforcement is that 12 this particular issue and change to the enforcement policy p

13 be noticed in the Federal Reaister. Now, that would go up i

( ,, 14 to the Commission, and the Commission would have to make a 15 determination. But because this' issue reaches so many 16 facilities, we think that it would be very important to 17 notice it and to provide public comment, so that licensees 18 as well as the NRC staff know what the levels are that 19 everyone is agreeing upon, or not agreeing upon.

20 MS. LIPOTI: I also have one more comment.

21 Dr. Wagner mentioned that the Radiation Safety Committee 22 knows where the weaknesses are. I'd like to corroborate 23 that, because when our inspectors go to a research 24 facility frequently the individual providing them the (O

V

< 25 access and the tour of the facility will say "and check NEAL R. GROSS '

COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20006-3701 (202) 234-4433

1 448 1 that guy'c lab. I'vG htd trouble with him." They do know l

l 2 I which of the researchers are less careful and require more 3 oversight. '

4 CHAIRMAN STITT: I Inside knowledge is always l

5 helpful. '

6 All right. Comments down the left leg of the 7 tree here?

.I 8 Dr. Swanson?

9 MEMBER SWANSON: Could you put back up your

). O first slide of the current regulations 20.801 and 20.802?

l 11 MS. JONES: Sure. These are 1986 regulations, l 12 but --

13  !

MEMBER SWANSON: I think where the problem i

14 lies is in the interpretation from an inspection is standpoint of the term " secure," which means locked 16 according to the inspection people, and in 20.802, the 17 issue of maintain constant surveillance is clearly 18 interpreted that they have to be at the site.

19 MS. JONES: Right.

20. MEMBER SWANSON: And my recommendation for a 21 regulatory change, again going to a performance-based type 22 of regulation, might be something as simple as, "The 23 licensee shall control license materials and control the 24 non-restricted areas from unauthorized access and 25 removal." '

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200( 5 3701 (202) 234-4433

.., . - _ - -. - .. ~_. -

449 1 MS. JONES: So change the word " secure" to 2 " control."

3 MEMBER SWANSON: And do away with 20.802.

4 CHAIRMAN STITT: Other comments? i 5 MEMBER GRAHAM: Was that a recommended motion, 6 as a recommendation from the staff?

7 MEMBER SWANSON: Do you want a recommended 8 motion on a regulatory change?

9 CHAIRMAN STITT: I think comments are probably 10 sufficient.

11 Larry?

12 MR. CAMPER: Well, the issue is if you -- if 13 the committee chooses to take an issue and pursue 14 consensus, then that carries a certain weight with it in 15 terms of consideration by the staff. Similarly, in i 16 reaching that consensus, if you have dissenting 17 perspectives,. bear that in mind.

18 You know, we will look -- I mean, the staff 19 will go back and review.the transcript and generally pick 20 up what the committ.ee seems to be saying, but if there are l 21 issues that the committee feels strongly about and you 22 want to make sure that the staff has an opportunity to at 23 least react to what you're saying, it's best in the form 24 of a motion.

( 25 CHAIRMAN STITT: Well, does that comment --

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON. D.C. 20006-3701 (202) 234-4433

. ~

450 1 done Dannie' comm:nt coms -- do 3 it tcnd to bring I

]

i I 2 lcogether some of the commentary that has been going on in 1

3 I this committee enough that we want to make that a motion?

4 Lou? i i

5 MEMBER WAGNER: Could you repeat it, just for l 6 clarity?

l 7 CHAIRMAN STITT: Dennis?

8 MEMBER SWANSON: Again, the background -- I ,

9 think the problem comes with the term " secure," which is 10 interpreted many times as locked, and " maintain constiant I I

11 surveillance," which I think is the other problem that the 12 licensees are complaining about. It would seem to me that 13 we would just or should change 20.801 to "the licensee I 14 shall control license materials stored and controlled in 15 unrestricted areas from unauthori' zed access or removal,"

16 and eliminate 20.802.

I 17 CHAIRMAN STITT: Lou? i 18 MEMBER WAGNER: I would recommend that the l

l 19 committee not make any specific recommendations on changes 20 in rulemaking at this time. We're going to get caught 21 into the same thing we got caught into before in terms of 22 our discussion.

23 I think what we really ought to do is look at 24 a general overall direction and guidance from the ACMUI 25 rather than something specific. And I'm not so sure that NEAL R. GROSS

• COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 20005-3701 (202) 234 4433 l

l 451 l 1

the interprctction of tha wording that you've given there ys 2 couldn't be misinterpreted according to our intent anyway.

(N-/ 3 The idea here I think is quite clear, and I 4 think the comments from the individual from the public are 5 taken in good accord. I think that that's -- he's right.

6 The facts are is that we have to put these things into a j 7

better perspective in terms of what kind of a risk they 8 represent to the public, and that is part of the directive 9 I think that is coming down from the Commission, and I 10 fully agree that we have to start looking at things better 11 in terms of risk.

12 And corrently what levels of risk are defined, 13 where should a heightened level of security be versus a

(

lower level of security, I think that needs to be defined.

\ 14 15 And I'm not going to make any recommendations on that 16 number now. I've just beeh 7.b?,e to review this thing, and 17 I don't have any specific recommendations on a number.

18 But I think, again,'the committee would be 19 willing to work with the Commission in trying to come and 20 to arrive at a solution as regards levels that require 21 higher levels of security than other levels, and what 22 represents a reasonable risk to the public in terms of 23 potential exposure of 100 millirem to individuals versus 24 500 millirem to individuals.

()

,m 25 I think that would be ,an appropriate thing for NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 200001701 (202) 234 4433

1 452 1

us to try to look ct, and that chould ba whare the 2 regulatory change should go in the future. In the 3

meantime, back off on the inspection procedures in terms 4

of -- and the regulatory process of enforcement because, 5

really, it is a contentious issue and things do get out of 6 hand when you take this zero tolerance and absolute 7 interpretation of what's going on.

8 The real enforcement issues, I think, should 9

look at the overall facility and should have a means by 10 which you can grade a facility in terms of the performance 11 that they're doing. And they should be graded. And, you 12 know, maybe there are a few violations one place or 13 another but they're not significant, because they don't 14 represent any real risk to anyone.

15 So I would simply recommend that as being the 16 overall guidance that is -- this committee ought to 17 consider in giving to the commission and in terms of 18 future direction.

19 CHAIRMAN STITT: Just some comments, and then 20 Jeff. It seems like a lot of what we are saying here 21 keeps coming back to the long discussion that we had l

22 yesterday having to do with risk. And although we're  !

23 having trouble getting more specific in definitions, I l 24 don't think that's a shortcoming of the group. I think 25 it's an evolutionary. a lot more time, a lot more work NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

453 1 nesdn to ba involycd.

But we are at least consistent. We f-~ 2 are saying some similar things over and over and over 3 again.

4 And I also want to point out that in spite of 5

the fact that Judith at least took the stand on this and 6 said,  !

"I cannot interpret DSI-12. I don't know what these  !

l 7 words are," I keep hearing some of these things coming 1 8 back both from Dennis and'from Lou about performance 9 based. So it's sinking in, and it's clearly part of a i

10 process that we're launching upon. '

11 Jeff?

12 MEMBER WILLIAMSON: Yes. I notice on this

,_ 13 page that starts out " Questions" with the square bullets, t

14 how many labs did the inspector review? I guess this is 15 what your current thinking is in terms of how you should 16 change the enforcement process of the existing I 17 regulations -- i 18 MS. JONES: Right. One of --

19 MEMBER WILLIAMSON: -- but you would not give 20 an institution a -- you would not say they are violating 21 this just based on a single isolated occurrence of an 22 unlocked vial, but only if more than 10 percent of the 23 inspected labs were --

24 MS. JONES: Ten percent or one percent or five (b) 25 percent. Someone at the break said to me, "You know, you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON, D.C. 20006-3701 (202) 23& 4433

454 1

renlly chouldn't dofina any parcent," and that probably 2 may be a way that we go to. But our enforcement, Office 3

of Enforcement, always comes back and said, "Well, what is ,

i 4 this minimum threshold? Or what is okay? What is in the 5 noise level?" And because of these events, we have '

6 inspectors that go out and are inspecting quite a few 7 labs, 2, 3, 400 labs during a week period.

8 And we normally go at breaks, lunch hour 9 breaks, evening off' hours, and, of course, that's when you 10 can find security and control problems. That's when 11 people are concerned about are they in control of the 12 material.

13 But one of the things that we're looking at is 14 if a licensee already has an audit program, which the 15 Radiation Safety Committee in many cases has said, "Take a 16 look at our program and then see where we have problem 17 areas. That's how you know if they're doing an okay job."

18 You find some people that have some problems and you 19 counsel them, say, "You know, you need to lock your door, 20 or you need to secure your material." Is those few 21 percent in the noise area, and is the overall program 22 doing okay?

23 Currently, we don't have a mechanism to say, 24 okay, less than some percent is okay because it is, as you 25 mentioned,-just every atom has to be secure. So we're NEAL R. GROSS COURT REPOR'ERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVEL, N.W.

(202) A N WASHINGTON, D.C. 20005-3701 (202) 234-4433

. . - - - . . . - - , _ _ - ~ - . - _. -

455 1

looking for a way to explain batter for both licensees and 3

'b 2 for us that there is a level. If your overall program is I

I j --

3 okay,.then these level the labs.

4 CHAIRMAN STITT: Lou Wagner?

5 i

MEMBER WAGNER

But see, there is something 6 you said there that just irritates me. It's the fact that 7 you have stated initially that the cause of the events,

8 those were malicious events. They are going out and -

i

\

1 9 inspecting more and more labs and trying to look for more l 10 and more things. The whole point is this is malicious l

11 event driven, and we shouldn't be worrying that much about

12 these malicious events. They are regulated by law. They j 13 will occur, because there are mean people out there in  ;

s ,/ 14 this world.

, 15 Hopefully, they're going to be rare, and as i

16 long as they are rare, we don't need to be enforcing 17 things that are going to affect the thousands of people in i

l 4

18 the environment who are trying to get research done on an l

19 efficient basis.

, 20 Now, this is excellent. I mean, you know,

' 1 4

21 number 1, you take a look at a program and you say, "Okay.  !

{ 22 Is it a sufficient program?" And two, you give advice as

) 23 to whether -- if they are doing a good program, but they  !

l 24 have some weak points, give them advice on it. Don't make t

25 it a contentious issue. That would be great. But the 4

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1 1323 RHoDE ISLAND AVE., N.W.

] (202) 23H433 WASHINGTON. D.C. 20005 3701 (202) 23M433

456 1 problem in thaea ieguas always bacoma contentious.

2 And the other issue is the inspector usually 3 is making recommendations a lot of times that -- levels of 4 radiation concern that are simply stupid. It's ludicrous 5 to be worried about these extremely small levels of 6 radioactivity, and so they do need guidance in terms of 7 what levels we should be really concerned about. And I 8 think we need that guidance. But that's going to be a 9 slow evolutionary process.

10 We're going to have to define those levels and 11 go through.a lot of work and maybe revisit this at another 12 time. In the meantime, try to give them some guidance in 13 the enforcement arena to back off and give this kind of 14 advice to people if you see problematic areas. And that's 15 fine, as long as it doesn't become a citation issue, a 16 fine issue, and a zero tolerance issue. And that's where I l

17 the contention and the problems comes in. 1

)

18 MS. JONES: Let me mention that you are 19 correct in saying that these events back last year started J

20 from malicious intent, or what have you. However, when I 21 incidents like that occur, and in this particular one 22 which was located at a licensee facility in the 23 Washington, D.C. area, it did raise a lot of public 24 attention. It raised congressional attention. And the 25 question that the Commission asked us at the time is: is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

___q 457 )

1 this a widagpread probicm? And tha staff had to answer 2 that question by looking in more depth at licensees' V l 3

facilities, which has happened over the year -- year and a  !

4 half I should say.

-l 5 Is it a widespread problem? No. And we're 6

thinking that that's the reason why we're proposing these 7 changes, because we do think there is a policy in place. ,

8 But it is not clear'enough. It is vague. It needs to be 9 better defined. And in doing so, can we establish a I 10 consensus on threshold number of labs, audit programs, and 11 so forth, that we can reach some kind of agreement on and 12 then move forward from here? So that's part of the-13 answer.

/ \

j 14 MEMBER WILLIAMSON: Well, I share Lou's 15 concern that, you know, you want to avoid the appearance 16 of having I think what looks like a very needed regulatory 17 change from being driven by a lurid isolated incident that 18 these -- this whole regulatory system can't even begin to 19 address.

20. MS. JONES: Right.

~

21 MEMBER WILLIAMSON: But no, I think you're on 22 the right track. I think a percentage somewhere on the 23 order of five to 10 is reasonable, plus evidence that 24 there exists within the institutional radiation safety 25 program, you know, a system for auditing and inspecting a G

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

458 1

ltrga fccility, you know, that there's clearly a working I 1

2 system for identifying bad actors and attempting to bring.. )j i

3 them into line.

4 I just think, you know, it's ludicrous to 5

insist on 100 percent performance with all of these many 6 little details. It's just -- unfortunately, so many of 7

them are unwarranted by any kind of risk it's just really 8

difficult to frighten everybody into obeying them 100 j 9 percent of the time. I I

10 CHAIRMAN STITT: And we don't want to forget 11 our mentor, Dr. Siegel, whose famous comment he left us 12 with, and we left him with, his yo-yo. That is, he was 13 fond of the regulation by yo-yo statement, and it's worth 14 remembering.

15 Other comments to make to Cynthia here? Are 16 we getting ready to wrap up this segment?

17 MS. JONES: The only thing I -- if I can just 18 mention to look at, and then we can maybe wrap this up in 19 the next five minutes, are do we really need guidance once 20 we establish -- if we can establish a change in 21 enforcement, we'll work on the regulation if that's what 22 needs to be done. If the Commission says, "Yes, you need 23 to change the regulation," I am sure that either myself or 24 someone from the Office of Research will be back here at 25 yet another meeting if we have proposed language.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

459 1

But would there need to be guidance if an p 2 enforcement policy were issued in the Federal Reaister, if

\U) 3 there was a change? And we can get into these factors.

4 MEMBER FLYNN: I think in the short term a 5 change of enforcement could be done in a short term. And 6 I like the word " control" that Dennis used, and I also-saw 7 up on the slide here, rather than " secure" or " direct 8 surveillance," because " control" could mean a lot of , l 9 things.

10 It could mean, for example, there could be 11 external control to a facility, or there could be -- for 12 example, you don't have line of sight of the isotope, but 13 you -- you know, you have reasonable line of sight of the

[, )

V 14 door where people could enter and exit a lab. It could {

15 mean a lot of things. " Control" is much more general than 16 " secure" and " surveillance."

17 CHAIRMAN STITT: I think there's more 18 flexibility to that term.

19 MEMBER FLYNN: More flexibility.

20 And then but it doesn't get -- and then, in 21 addition to control, which is open to interpretation then, 22 then you have level of risk.

23 CHAIRMAN STITT: John, you have a comment?

24 MEMBER GRAHAM: Specifically, question

' 25 number 3. I'm hearing a consensus build among this NEAL R. GROSG court REPORTERS AND TRN.SCRWERS 1323 RHODE ISLAND AVE. N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4 433

460 1

committoo that tha licansco shnll control license 2

materials stored in controlled or unrestricted areas from 3 unauthorized access or removal. That's the level of 4

guidance that I think we're recommending ought to be given 5 to licensees.

6 And specifically, in the short term 7 opportunity to make the enforcement more rational, it i

8 would be to move away from this issue of maintain constant 9 surveillance, which is not realistic from a risk-benefit 10 analysis in a large number of situations.

11 MS. JONES: Thank you.

12 CHAIRMAN STITT: All right. Everybody feel l 1

13 like they've had their say? Good.

14 Thank you very much, Cynthia. O!

15 MS. JONES: Thank you.

16 CHAIRMAN STITT: And as you say, I'm sure we 17 will be hearing from you or someone again. .

18 MS. JONES: Well, we appreciate greatly your 19 input and --

20. CHAIRMAN STITT: Okay. These are resumes?

21 Being circulated are some biographies. You know, if 22 nothing else, we stay awake during these meetings and we 23 keep the staff busy, because we want to be kept as 24 informed as possible. So you're going to be receiving the 25 biographies of the current five commissioners.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 23M

, . _ _ . . . _ . _ . _ _ . _ _ . . . _. s _. _ . . _ . - . _ ._,_..-.___._._.___m_.- .. . _ .-- _ _ _ .

i 461

1 All right. John?

2 MEMBER GRAHAM: I just'had one other request.

V 3 Lou was referring to an organization chart yesterday.that 4 clarified the. role and relationship of.the ACMUI to the 5- Nuclear Regulatory Commission. I-would find that very-6 beneficial --

7 CHAIRMAN-STITT: There is an issue that I --

8 MEMBER GRAHAM: -- if they could send it'to.us 9 or --

10 CHAIRMAN STITT: Yes. There's an issue I can 11 bring up now. It's administrative. But as we have new

'12 members come on, I'd like maybe just a couple of heads to 13 werk with me on this and the staff. We need some sort of 14 a new member packet to help with this' learning curve. And.

15 that, to me, would be a very important part.

16 We_have Part 35 that was stuck in our_ packets.

17 Everybody ought to kind of' sleep with that under their 18 pillow. . So I'll work with the staff on -- if you could e-19 mail me comments that you have about what have been 20 helpful to you, everything from hotels to metro stops to 21 structure --

22 MS. TAYLOR: Judy?

23 CHAIRMAN STITT: -- e-mail me --

24 MS. TAYLOR: I do quite a bit of that already.

25 CHAIRMAN STITT: Okay.

5 NEAL R. GROSS count aspontans AnoinANScamens 1323 RHODE ISLAND AVE., N.W.

(202) 23H433 WASHINGTON, D.C. 2000H701 (202) 23H433 I

R 462 1 MS. TAYLOR: Eachnwmbmbargetsacopyof 2

Part 7, which applies to advisory committees, 19, 20, 35, 3 33. I give them the Regulatory Guide 10.8, the 4 supplemental appendix to that that incorporates the 5 Part 20 changes. We handed out the org. chart last 6 meeting. I've got to make copies. So most peopl'e do get 7 that now.

8 CHAIRMAN STITT: As they come on as new 9 members?

10 MS. TAYLOR: Yes.

11 CHAIRMAN STITT: Okay. Do they have a list 12 of, say, membership on the committee?

13 MS. TAYLOR: I tend to sporadically give that 14 at new meetings as it changes, and I do need to send a new 15 list out because there have been 'hanges. c l 16 MEMBER SWANSON: If I may make -- along with 17 the issue of organizational structure, if I could 18 recommend at the next meeting if we had a brief discussion 19 of the NRC's organizational structure, how our decisions 20 flow through that structure, if decisions are made by the 21 Advisory Committee that are subsequently not -- don't 22 appear in the regulations -- and we have one coming up 23 here in a minute -- who makes those decisions, are those 24 decisions made by the Commissioners to disregard our 25 recommendations, is -- you know, are we -- should we be NEAL R. GROSS '

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

463 i getting rationale for thoso decisions, scientific basis i

-s 2 for.those decisions, etcetera.

So I would like to see how

\-- 3 our decisionmaking process flows through the NRC 4 structure.

5 CHAIRMAN STITT: Can we do that? It will 6 probably look pretty vague, but I think that's -- it can l

7 be very frustrating. In-fact, we're talking with the 8 Pope. You never -- or maybe we're using the Pope to talk '

9 to God. You never get this direct 3 .. It's very 10 indirect and it's difficult to know if there is feedback.

11 Larry? I l

12 MR. CAMPER: We will attempt to clarify that 13 process.

l

\ 14 CHAIRMAN STITT: I think -- never mind. I 15 won't say that on the record.

16 Let's move on, because it sounds like Dennis 17 has some issues here. Inspection guidance for final 18 patient release rule. "

19 MR. DeCICCO: Good morning. I have been asked 20 to present some information concerning the 35.75. In 21 October, the Commission approved the final rule clarifying 22 the application of 35.75 to patient release. The 23 rulemaking basically clarified that 35.75 was that rule 24 that governed the release, and that Part 20 was no longer 25 applicable to the patient release criteria.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 236 4433 WASHINGTON, D.C. 200C6 3701 (202) 234 4433

7 464 1 {

It alco clarificd that ths parmitted dose to l

2 an individual being exposed to the patient -- or the l

3 individual patient was a total effective dose of 500 '

l 4 millirem in the year -- or, excuse me, for the occurrence.

5 The Division of Industrial and Nuclear 6 Medicine -- excuse me. The Division of Industrial and )

7 Medical Nuclear Safety is in the process of developing 8 some guidance for inspection against the new rule, so that l 9 they can be applied at the same time that the rule becomes 10 effective. And with the development of the rule -- or, l 11 excuse me, with the development of the inspection 12 guidance, those guidance will be sent to the regional 13 inspection offices for their comment and incorporated.

14 And part of what we're going to do this 15 morning is basically solicit comments from this body to l 16 help us develop these preliminary guidance.

17 What I'd like to do is basically go through l 18 the four subparts of the new final rule as they will 19 appear in the Federal Recister and will become effective, 20 and then we'll -- I would like to go through each one of 21 the subparts to show how the guidance for performance-22 based inspections should -- are going to proceed.

23 Basically, there are four subparagraphs in 24 35.75. The first one is the actual criteria for the 25 release of.the patient. The licensee may authorize NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

465 l 1 release from individualo receiving radioactive materiel,

,~s, 2 if the total effective dose to any individual other --

\

k/ms 3 from the exposure or from the released individual is 500 4 millirem, or five millisieverts for the treatment.

5 There is a footnote here which will also 6 appear in the regulation, and the footnote is there to 7 alert the presence of a regulatory guide, 8.39, which is 8 basically regulatory guidance for the licensee on how to 9 calculate the individual doses and other guidelines for i

10 the release of the patient.

11 Subparagraph (b) says that when you are 12 administering a radioactive material, the licensee shall 13 provide the individual -- the released individual --

14 instructions, including written instructions, on actions 15 recommended to maintain doses to the exposed individual as i

l 16 low as reasonably achievable, and that the instruction '

17 needs to be given if the exposed individual to the patient 18 is.likely to exceed one millisievert or 100 millirem.

19 MEMBER WAGNER: Wait a minute. Wait a minute.

20 Did you say that right? I'm sorry. I'm going to read 21 this again. To maintain doses to other individuals as 22 those -- at the total effective dose equivalent to any 23 other individual. You said "the patient."

24 MR. CAMPER: He said "the indi71 duals exposed 25 to the patient."

[O)

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVEL, N.W.

(202) 2364433 WASHINGTON, D.C. 20005 3701 (202) 236 4433

466 1 MEMBER WAGNER: Okay. I'm sorry.

2 MR. DeCICCO: Well, I was obviously unclear.

3 Yes. The 100 millirem is to the individual exposed --

4 MEMBER WAGNER: To the patient.

5 MR. DeCICCO: -- to the patient.

6 MEMBER WAGNER: Okay. I'm sorry. Thank you.

7 MR. DeCICCO: Subparagraph (c) -- or, excuse 8 me, subparagraph (b) has two sentences in it. "If the E dose to a breast-feeding infant or child could exceed one 10 millisievert, assuming that breastfeeding is 11 uninterrupted, then the instruction shall include guidance 12 on the interpretation" -- or, excus'e me, " interruption or 13 discontinuation of breastfeeding, and the information on 14 consequences of failure to follow the guidance."

15 MEMBER SWANSON: A comment. This is where I 16 would like to comment that at the last ACMUI meeting the 17 Advisory Committee made the recommendation that the term 18 " consequences of failure to follow guidance" be changed to 19 " rationale of failure to follow guidance" because of the 20 difficulty in explaining the consequences of low level l

21 radiation exposure. That committee -- that recommendation l l

. I 22 was soundly made by the committee, and I think understood j 23 by the people from the materials program. And that is, in l l

24 fact, my concern as to what happens to these decisions and  !

25 how are they overturned.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON, D.C. 20005-3701 (202) 234-4433

467 I 1 CHAIRMAN STITT: Lou?

1 i

f_s 2 MEMBER WAGNER:

f I would like to enforce what j

\ 3 Dennis has just.said, because this is extremely important.

4 i There are no -- there is no way'to give any information on 5 the consequences of low doses of material, because we have 6

-- there is no evidence (a) that there are consequences, 7 and to explain consequences is just an impossible medical 4

q 8 thing in the relationship between the doctor and the  !

9 patient, regardless of whatever guidance the NRC gi'ves us 4

10 on this issue.

\.

11 j

The word " rationale" was chosen because the i 12 word " rationale" covers the broad spectrum of activities

,- s 13 of why you want to do things. Even if you don't know- i l

lk,)-

1 14 whether or not there are any consequences to it, the 15 reason you want to do this is because you simply want to i

16 be precautious (sic). You want to take the best

{,

17 precautions possible to not relay any radioactivity to a 4 18 breast-feeding child.

, 19 And to completely defy the recommendation

20 after it had gone under long discussion and went through a clear discussion about the medical implications of this i 21 22 word versus rationale, to defy it, it makes me a little 23 angry, and I'm mildly outraged at the fact that they have 24 just simply turned this over and decided to use

( 25 consequences, despite all the arguments we gave against

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS i

1323 RHODEISLAND AVE N.W.

(202) 23N WASHINGTON, D.C. 20006-3701 (202) 23M

468 1 it.

2 CHAIRMAN STITT: Judith?

l l

3 MEMBER BROWN: Well, I think it's no big deal, 4

and the reason is because if you talk -- or if you give I 5

them the information on the consequences of failure to 6

follow the guidance, you could be saying, "And now I have I 7

no idea what's going to happen to your baby, because we 1 8 don't know exactly the medical consequences." l 9 MEMBER WAGNER: That's not a consequence.

10 That's a rationale.

11 MEMBER BROWN: To me, in lay terms, the 12 consequence and rationale -- and they probably made that 13 executive decision -- I think it's really no big deal.

14 MEMBER WAGNER: But, Judy, with all respect, I 15 think that that clearly defines the differences between 16 medical practice and those who are actually practicing 17 medicine and meeting up with the difficulties of 18 practicing medicine, and the interference of this into the 19 practice of medicine, versus other individuals who don't 20 practice medicine and don't understand the real 21 implications of these kinds of problems.

22 And I think you are clearly delineating that, 23 because you are the member of the public, you are the 24 public's representative on this, and it's quite clear --

25 when we've got to deal with this with patients, and deal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

.. - . .- -. - . - - - - - ~ .~ _ . , _---.- .

469 1 with theco kinds of issuan, you've got sensitive issues 1

s

f 2 that you've got to deal with patients on, and you've got

\

, 3 to handle it in the most appropriate way possible to best 4 manage those patients.

I i

5 MEMBER BROWN: They aren't saying medical 6 consequences. They're just saying consequences.

4 7' Consequences is just an English word. You don't have to j 8 put it in the purview of only physicists and medical 4

9 people.know what consequences are.

} 10 MEMBER WAGNER: But there are no known s

i. 11 consequeneca. A consequence to say there are no --

{ 12 MEMBER BROWN: Well, that's what you tell 13 them. The consequence is: there are no known i j 'v 14 consequences.

15 MEMBER WAGNER: That's not what it says. i 4 l 15 MEMBER SWANSON: If you tell them there are no i

17 known consequences, you've defeated the purpose of giving 1

18 them the instructions to begin with.

l 4

1 19 CHAIRMAN STITT: Well, and I'd like to remind 20 the committee that our first name is Advisory, and I 4

d 21 suspect that the. Commissioners can do anything they -- I 22 don't suspect; they can do whatever they want. And we can 23 advise, and they are -- my understanding is they have 24 absolutely no obligation to do anything with what we send 1

C\ 25 them.

! NEAL R. GROSS l'

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2001 5 3701 (202) 234 4433 4

5'

. -w 470 1

But I egree with you, it's vary fructreting 2

because we spend a lot of time and a lot of effort trying 3 to be good medical citizens.

4 MEMBER WILLIAMSON: I would like to ask, who 5 overturned the recommendation of the Advisory Committee?

6 Was it the staff or the Commission?

7 MR. CAMPER: I don't think " overturned" is the 8 right word.

9 MEMBER WILLIAMSON: Disagreed with.

10 MR. CAMPER: I'm not necessarily sure that 11 " disagreed with" either is the right word. What happens 12 is, as Dr. Stitt pointed out, the committee advises the 13 staff. The staff subsequently -- for example, the program 14 office interfaces with the Office of Research, which is 15 charged with rule development. Recommendations of the 16 committee are considered during that process. Some of l

17 them are, in fact, accepted. Some of them are not.

18 I do not recall specifically why this 19 particular recommendation wasn't accepted. I could 20 examine that. But there is a deliberative process that 21 goes on between the Program Office and the office charged 22 with writing the rule. Subsequently, the rule is 23 presented to the Commission, the Commission's staff 24 assists the commissioners in reviewing the rule, and then 25 the Commission may direct changes to the rule. It may NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234-4433

471 1 reject tha rule. It mny ack tho staff to take a different 4

,-~ 2 pathway. It's a number of steps in the process.

-' 3 There is legal review and interaction with the 4 Office of General Counsel as part of that process. So 5 there are -- it's a multi-faceted process.

3 6 CHAIRMAN STITT: Lou?

7 MEMBER WAGNER: I think I do know the reason 8 why this was overturned. The reason it was overturned was 9 because of the potential consequences of iodine-131. And 10 it's an example of how a very narrowly focused risk is

11 guiding and effecting a very broad spectrum of things that 12 don't have any risk that's associated with them. That is 13 the reason they chose the word " consequences," because s

, b)

\, 14 they wanted that in there for iodine-131.

15 Well, we could have put in " rationale" here I 16 and have just as effective'a meaning, and then explained 17 in the guidance that within the rationale the consequences 18 of iodine-131 should be explained to the patient. That

, 19 would make a heck of a lot of sense. But to put 20 consequences in here with disregard for all of the other 21 things that don't have any consequences, or at least don't l 22 have any known consequences, it's backwards.

4 23 MR. CAMPER: Well, the suggestion that I would 24 make at this point, as I certainly perceive the

(~

4 25 disenchantment, and I understand -- and you're right, a i %

NEAL R. GROSS -

, COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON, D.C. 20006 3701 (202) 23 4 433

472 1 grott danl of tim 2 wns d; voted to thic. Parhtps wh:t the 2

committee would consider doing is this -- although this 3

rule is about to be -- is going to be published as a final 4

rule -- in other words, the Commission has deliberated and 5 approved the rule.

6 Certainly, the committee could, if you prefer I 7 to do so, go on record with a recommendation that the 8

staff would reexamine this prior to publication, and your 9 rationale for doing so. You certainly could do that.

10 From a program perspective, we could examine whether or 11 not --

what the possibility is for doing that.

12 CHAIRMAN STITT: Comments regarding Larry's j 13 commentary? John and then Jeff.

14 MEMBER GRAHAM: Given we're an advisory '

15 committee, given we're part of a political process, given 16 that this rule is about to be published, we're being asked 17 for professional recommendations that go out as part of

. 18 the enforceme'nt. And you get back to page 7, we're saying 19 that inspectors are going to go out and ask is there 20, guidance on interruption of breastfeeding and the 21 consequences of failure to follow the guidance.

22 So I think we, as a committee, have an 23 opportunity to clarify as part of the instructional 24 material to go to inspectors that consequences may be a 25 less-than-ideal word, and that there simply needs to be h NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

- . . . . - . . ~ . . . . . . - - . . . - - . . . . . - - - - . - - - - . - . . - - .

, 473 L

1 avidenco that the rationale -- that the consequences 2 and/or the rationale have been documented in that case, c (g 3- There is still an opportunity for us to affect j 4 the way the people that have to go out and enforce this 5 are going to look at it, so --

6 CHAIRMAN STITT: Right. And I think the way I

}

7 this was listed on'the agenda is inspection guidance. We -

8 are being. asked for our advice. I'know that we've already I 9 made half the committee sour because we have given advice j 10 before and feel like no one is listening. We are being 1

11 asked to give advice on the inspection guidance for this l

i

)

12 particular rule. So John's point is very wellLtaken. We 13 need to remember that as we continue our discussions.

14 Jeff?

15 MEMBER WILLIAMSON: Well, since Larry has 16 offered to have the wording of the rule reexamined, I --

17' MR. CAMPER: Wait a minute. I'm saying --

18 what I said was the rule was published as a final rule.

19 I'm saying if the committee feels strongly enough about 20 this position that your advice was not adhered to, and you want to make a recommendation that that term be 21 22 reexamined, from a programmatic office standpoint I am 23 willing to see what can be done to have it reexamined.

24 MEMBER WILLIAMSON: Okay.

25 MR. CAMPER: I'm not saying having the rule NEAL R. GROSS count REponTams AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

l 474 1 rccxaminsd.

2 i MEMBER WILLIAMSON: All right. Well -- i 3 MR. CAMPER: Subtle difference there.

l 4 MEMBER WILLIAMSON: Yes, I see. It is quite 5 subtle. l 6 I would just comment --

I mean, this seems 7 like an extraordinarily prescriptive rule specifying down 8 to the letter what records are to be kept, what occupancy ,

9 factors and what not are involved in the decision to keep {

10 records. It just seems like this is more appropriately --

11 MR. CAMPER: But those were examined with this 12 committee at great length, and the committee essentially 13 agreed with these terms. This -- I mean, this -- what you 14 see is a reduction in criteria, to a large degree based 9i 15 upon deliberations with this comm'ittee. And, I mean, in 16 all fairness.

17 MEMBER WILLIAMSON: Good. I just would have 18 thought perhaps a very -- I like the first paragraph. I 19 think the rule -- it would be well to limit the rule to 20 just that.

21 CHAIRMAN STITT: Any comment? Does anybody 22 want to make a motion on this reexamination that Larry 23 said could be done by the staff? Want to let it sit, or 24 want to force the issue?

25 MEMBER NELP: As a person who is intimately NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234-4433

475 1 involved in this instruction, I don't see a problem with.

f-'s 2 the way it's worded. I think that it's not necessarily an

$ k -) 3' ideal word.

But for me, to translate this as a 4 responsible individual to the patient, I don't have a 5 problem with it.

4

, 6 CHAIRMAN STITT: Well, we want to remain 7 focused on how we see these words in the inspection 8 guidance. It could come out very differently as to how 4

9 it's being enforced out in the field.

10 Lou?

4 11 MEMBER WAGNER: I think that's the point. As 12 a physician, you could take that, iinterpret that, and do

,-.s 13 that in the best way possible with your patients. The

( )

(m /' 14 whole question nos becomes when it's enforced and you've i

15 got these consequences and these words in here, this is 4

16 where a lot of our contentious issues start springing.

s 17 It's a matter of taking these kinds of terms and saying, 18 "Well, you didn't explain the consequences to these 19 patients." And I agree.

20 That's where we now need -- the focus is on 21 the enforcement issue, and say, "Okay. This word 22 ' consequences,' you know, consequences may be an extremely

) 23 mild issue in terms of when the physician converses with 24 his patient for things like technetium and other things."

25 And clearly, the rationale is to minimize inadvertent NEAL R. GROSS court REPORTERS AND TRANSC,AISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

476 1 rcdiation exposuro to a bracst-facding child. And we 2

don't know that there are any consequences, but doggone i 1

~

3 it, it makes sense to reduce this.

4 MEMBER NELP: Well, this is verbal or written 5 instructions?

6 CHAIRMAN STITT: Well, it's --

7 MR. DeCICCO: That will become more clear.

8 CHAIRMAN STITT: Keep going. Would you 9 please?

10 MR. DeCICCO: Okay. Third paragraph of the 11 regulation says, "The licensee shall maintain." This 12 paragraph and the following paragraph are the only two 13 paragraphs that mention records or recordkeeping. The 14 previous two paragraphs are basically a regulation for the 15 patient release and what needs to be done.

16 "The licensee shall maintain a record for 17 three years after the date of release, if the total 18 effective dose is calculated," and here's a litany of ways-19 of determining dose to the indivibal exposed to the 20 patient using the retained activity rather than the 21 activity administered, using an occupancy factor less than 22 .25 at one meter, using the biological or effective half-23 life, or considering the shielding of tissue.

24 So if you use other than the administered dose 25 and use one of these methods, you need to keep a record of f NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON D.C. 20005 3701 (202) 234-4433

477 1

thnt feet and the fact that you used that criteria to

, -~g

, 2 release the patient.

j 3

The last paragraph is the other record that be i 4 maintained for three years after release, that '

5 instructions were provided to the breast-feeding woman if 6

the radiation dose to the infant or child from continued {

7 breastfeeding could result in a total effective dose of 8

five millisieverts or 500 millirem. Okay?

9 So there is a criteria for requiring i

10 instruction, and there is a criteria for recording that 11 the instructions have been given, and there is a  !

l 12 distinction.

l 13 g-- You want to refer back to the first paragraph. l

( ,g) 14 A performance-based inspection criteria might look l

15 something like this. I asked licensees to describe how it 16 demonstrates co.npliance with the actual release of the 17 patient. Is there a process to determine if the total i

18 effective dose to other individuals not likely to receive 19 five millisieverts, is there a process to determine if a 20 maximally exposed individual is a breast-feeding child or 21 infant, or is there a process in place to determine the 22 dose to the breast-feeding infant?

23 And this is, again, to find out whether --

24 what the dose is or what the dose might be to the

[ \ 25 maximally exposed individual, and to determine whether L.Y NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N W.

(202) 23H433 WASHINGTON D.C. 20006 3701 (202) 234 4433 L

478 1 instructions nacd to ba given, and whether the actual 2 instructions -- not the actual instructions, but whether 3 the instructions were given as documented. Okay?

4 This is, again, something that the inspector 5 would go in to a licensee and basically discuss or ask of 6 the licensee and get a feel for, here's the requirement. l 7 Is there a process there to comply with that requirement?

8 Not dictating what steps need to be done. But, you know, 9 is there a process there?

10 MEMBER NELP: This implies to me that I have 11 in my clinic a set of instructions which have been l

12 provided by you, and I say, "Here. Every time we do this 1

13 -- every time we treat someone we want to have -- assure 14 that these things are under consideration." But I don't G,

15 think you're asking me to hand the patient a set of 16 written instructions. What I ordinarily would do would 17 take the patient's medical record and say, "I administered 18 this. I explained to the patient'the procedures and the 19 precautions and reviewed the fact that she should not be 20 breastfeeding," etcetera, etcetera. "These instructions 21 were given to the patient."

22 But you're not asking me, if I read these --

23 MR. DeCICCO: Not there yet.

24 MEMBER NELp: -- the way they're written.

25 MR. DeCICCO: Not in this paragraph we're not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. I (202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 6 i

. . _ . - -- -. .. . .. --. .~ . .

l 479 1 asking you to do that, but in a later parcgraph there is a 4

2 variation on that, yes.

f,~'h 1

s- 3 MEMBER NELP: So you want -- okay.

4 MR. CAMPER: This is dealing with 35.75 (a) . t l

5  !

, MR. DeCICCO: This is just, how do you j 6 determine whether you can release the patient.

7 MR. CAMPER: Right. I 1

8 MEMBER NELP: Yes. But you just told me that 9 I should make a record of that.

10 CHAIRMAN STITT: Dennis, comment? And then 11 let's go through these and then discuss them after we get 12 through them.

13 MEMBER SWANSON: Under the first question, my

( ,) 14 issue boils down to: how do they have to -- or is there 15 going to be a need to document this process? You could 16 say my process for determining that the total effective 17 dose is not likely to exceed five millisieverts is to go 18 by the chart that's in the reg. guide. And I do have 19 documentation of that in that I have records to l 20 demonstrate how much everybody received. Okay?

21 The second one, though, is there a process to 22 determine if maximally exposed individuals are 23 breastfeeding an infant or a child, if I respond by 24 saying, you know, we ask every woman if she is 25

( breastfeeding an infant or a child, is that going to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIGERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4 433 WASHINGTON, D.C. 20005-3701 (202) 2344433

480 1 cuitablo, or do I need to document th t, in fact, we have 2 asked every individual and have them sign a statement to 3 the effect that they have been asked that question.

4 MR. DeCICCO: The requirement, as it stands 5 now, is that there is a requirement to determine. There 6 is not a requirement to document that the question has 7 been asked, or to sign a release saying that this is the 8 patient's signature that says this is the patient's 9 answer.

10 MEMBER SWANSON: I think that is, in fact,  !

11 where we get into a lot of problems with how these 12 regulations are enforced, is the typical response of the  !

13 I inspector is, "Well, where is your documentation that that '

14 process is taking place?" OI 15 MR. CAMPER: You're right. But literally, 16 what Joe is showing you is the type of instructions that 17 would be provided to the inspectors in our guidance, and i 18 they would be asking these questions. This is the extent 19 of the questions they would be asking, and they would be 20 documenting, and so you would know that, in fact, these 21 questions were asked. I mean, we are saying to you, this 22 is exactly what the inspection guidance has said.

23 MEMBER SWANSON: And I'm just getting into the 24 public record that the next step should not take place.

25 Okay? That --

NEAL R. GROSS COURT REPORTERS AND TRANSCR'BERS 1323 RHODE ISLAND AVE NW.

(202) 234 4 433 WASHINGTON D.C. 20005 3701 (202) 234 4 433

a 481 1 MR. CAMPER: Right.

2 MEMBER SWANSON: -- the next step for the 3 inspector to say, "Okay. Show me the documentation that .

4 that process is taking place."

5 MEMBER WILLIAMSON: Does there need to be in 6 the inspection guide a specific prohibition saying that 7 records are not required to document the existence of this '

8 process, simply sort of reviewing by interview that the 9 process occurs, and maybe observing one or something is ,

10 sufficient?

11 MR. CAMPER: The regulation is explicit on 12 what records are required, and those are the only records 13 that are required.

14 I mean, for example, if you look in 35.75 (a) ,

15 you find that there is the determination -- you know, you _

16 may release up to 500 millirem. Okay? And you get over  ;

17 to 35.75(c), you've got this record for maintaining the 18 basis for authorizing release for three years if you do it 19 other than following certain criteria. But there is no i

20 additional -- I mean, the records requirements are l 21 explicit.

22 CHAIRMAN STITT: But the committee's concern 23 is that all variety of things get interpreted and put into 24 a manner of practice that may not be required by

( 25 regulations, and that has been the clinical experience of NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON D.C. 20005-3701 (202) 234 4433

7 482 1 tha group. In that the sense of fructration that I'm 2 hearing?

)

3 MEMBER GRAHAM: And if I could further 4 clarify. Running a hospital when this hits risk 5

management, my attorney is now going to say, "How are you 6

documenting that we, as an institution, are complying with 7 this rule, so that somebody doesn't come back and sue us 8

in the future alleging that there was damage to a baby l

9 because of this?"

i 10 And so even though we write out for the i

l 11 inspector that it doesn't have to be written, the fact l j

l 12 that you have to have a process to determine if a i 1

13 maximally exposed individual was breastfeeding an infant 14 or a child, once it gets down through the' risk management 9:,

15 process of running a hospital is still going to have, yep, i 1

16 I want to see on a chart where you asked that woman and l 17 you've documented you asked her. So --

i 18 MEMBER BROWN: Well, I want to see that on a 19 chart.

20 MEMBER GRAHAM: -- we're compounding that.

21 MEMBER BROWN: Let alone an inspector, I want 22 to see that on a chart. I don't think there is any 23 problem with that. Don't you do that anyway?

24 MEMBER GRAHAM: Not write it on the chart, no.

25 MEMBER BROWN: Well, how would you, as the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 5 3701 (202) 2344 433

483 l 1 horpital cdministrator, just know for yournalf that the 2 woman was asked the question?

\ 3 MEMBER GRAHAM: I'd define it in written 4 policy and procedure and randomly survey to determine that 5 it's happening.

1 6 MEMBER NELP: John, I will almost guarantee I 7 you that that information is part of the patient's medical-8 record in terms of not only good but average medical 9 practice. So I'm sure it's in your chart if you look for 10 it.

11 MEMBER GRAHAM: In part, I'm just jumping 12 ahead because you're about to see that you have to be able

13 to prove you documented this written instruction, l Ci

( )

14 including the consequences. Coming on the next slide.

15 MR. DeCICCO: Now, again, this is a guidance 16 for the inspector. There is not a requirement to have a 17 process from that first paragraph. The paragraph says,

. 18 "You may rele'ase a patient." Okay. This is a question 19 that an inspector might go in and ask to find out how the 20, program is running.

21 MR. CAMPER: See, you recall -- that's a good 2 22 point. I mean, 35.75 (a) says there's an absolute limit of 23 release. It's 500 millirem.

l 24 You might recall that when we were developing

( 25 the guidance, the idea was to say how one met this was to NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHoOE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 20006 3701 (202) 23H433

484 1

ba cble to refer to the tables contcincd within the 2

guidance which dealt with administered activity. They  !

3 were very conservative estimates. l 4

Then, it went on -- but we also recognize that l i

5 considering things such as biological half-life, for 6 example, tissue attenuation, and things of this nature,  !

7 could dramatically impact the release capacity, obviously.

8 I And then what 35.75 (c) is saying is if you choose anything I 9 other than those things established there, there is a need i' 10 to have this record. Okay?

11 MR. DeCICCO: Just to reemphasize that that 12 first paragraph in 35.75 has that footnote to make sure 13 that 8.39 is there, and as a point of record, documenting 14 that a patient received 30 millicuries of technetium-99M, 91 '

15 if you go to the chart in that reg. guide, there is no 16 requirement for retaining the patient. There is no 17 requirement for giving instruction. That would be your 18 documentation to comply with the regulation.

19 CHAIRMAN STITT: Dennis?

20 MEMBER SWANSON: The problem comes in with the 21 breast-feeding infant, and the problem is going to be if 22 you look a Table 2 of the reg. guide, there are many 23 radiopharmaceuticals that are routinely given to patients 24 -- technetium MAA, pertechnetate, technetium red blood 25 cells, in vivo labeling -- that are going to require that h

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 2344433

. ._. _ _ _ _ _ _ _ _ m ._. . _ _ _. _. . . ._. m 485 1 instructions ba givsn to pregnent -- or, excuse me, to

(

'x\

2 breast-feeding women because of the 100 millirem limit.

} 3 Okay?

4 And so, you know, there is -- because of that, 5 the requirement for written instruction, you're also going 6 to have to ask if there's a process for dete.rmining if all 7 of the women are breastfeeding, and then I'm back to the 8 same issue. Are we going to document that process? I 9 mean, you know, it's the reality of trying to put this 10 into effect that's the problem.

I 11 CHAIRMAN STITT: I think the practicality is a 12 combination of what you're bringing up, and then John just ,

1 13 talked about it in a day-to-day setting, as well as 14 Judith's comment, and I'd really want to know that.

15 Let's hear more about B, because we have A, B, 16 and C as a group.

17 MR. DeCICCO: B is the subparagraph that talks 18 about providing the released individual instruction, 19 including written instruction on actions to basically keep 20 exposure down to a minimum and to an individual who is 21 likely to be exposed to the patient and receive one 22 millisievert.

23 Some performance-based inspection guidance 24 might be to review the instructions provided to the O 25 released individual. Now, how would you do that? Is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433  ;

m 486 1 thera cn instruction written or a cample of the written i 2 instructions that is of a generic nature to, say, a 3 technetium patient?  !

4 Is there instruction available for an 5 individual that is breastfeeding an infant or a child that

, i 6 might -- where the child will receive one millisievert or l 7 more? Or is there guidance on interruption of 8 breastfeeding and the consequences of the failure to .

9 follow that guidance?

10 And again, the inspector would go in and say, 11 do you have a sample? Or how do you document it? Or, 1

12 excuse me, how do you instruct a patient? How do you l

13 comply with the requirement that the instruction be 14 written? It could be either actually a handout, which is O1 l 15 preferable, or -- and easy, or something that is 16 documented in the patient's record.

17 MEMBER NELP: Wait a minute. There is quite a 18 difference. A handout means you have provided the patient 19 with a written document of instructions. But then you 20 said something in the patient's record. In other words, 21 can I say, "I spoke to the patient. I explained to her 22 what had happened. I told her about breastfeeding. She 23 is instructed not to do that," and make that a part of her 24 medical record? Does that satisfy your requirement?

25 MR. CAMPER: We need to look at the words of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHNGTON. D.C. 20005-3701 (202) 234 4433

487 1 the rule. The rule says --

y 2 MEMBER NELP: I was just referring to what he

(

\ 3 said.

4 MR. CAMPER: No, I understand. But to answer 5 your question, look at what the rule says. "The licensee i

6 shall provide the released individual with instructions, 7 including written instructions, on actions recommended to e

8 maintain doses to other individuals as low as reasonably 9 achievable, if the total effective dose equivalent is 10 likely to exceed one millisievert." So verbal 11 instructions will not satisfy under those circumstances. i 12 MEMBER NELP: But that's only to do with 13 exposure to other individuals.

14 MR. CAMPER: Clearly.

i 15 MR. DeCICCO: Yes. j 16 CHAIRMAN STITT: Comments on this section? Or j 17 do you want to finish with C and then-come back and --

18 MEMBER WAGNER: Yes. *I have one question with 19 regard to this. And the question that comes is.this:

20 potentially, any woman, virtually any, depending on age, 21 could be breastfeeding, and we have signs in our

- 22 department which alerts a woman that if she is 23 breastfeeding she should notify the technologist. And if 24 she is breastfeeding, of course, then there is always the 25 potential that the child could receive more than 100 NEAL R. GROSS COURT REPORTERS AND TRANSCRI8ERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

~

_l 488 1 millirem from whatever activitias. Is this virtually 2 going to mean -- so say a woman comes in who is 3 breastfeeding and gets -- and doesn't fess up to the fact I 4 that she is breastfeeding. You didn't give her written 5 instruction.

6 MR. CAMPER: The rule does not require you to 1

7 inquire or determine.

1 8 MEMBER WAGNER: How are you going to know? l l

l 9 MR. CAMPER: We discussed that. And the rule 1

)

10 does not require you to do that. Purposely, the rule does  ;

1 11 not require you to do that.

(

l 12 MEMBER WAGNER: Then I'm very confused as to 13 whether or not we have to give written instructions to all l

14 women who are potentially breastfeeding.

l 15 MR. CAMPER: I mean, Lou, you're going to do l 16 what you normally do anyway. You go -- as you just said, 17 you go through that exercise anyway. But this agency is 18 not requiring you to do it in this rule.

19 MEMBER WAGNER: No requirements to do what?

20 MR. CAMPER: To determine if they are 21 breastfeeding their --

22 MEMBER WAGNER: No. That wasn't my question.

23 My question was the written instruction -- are we required 24 to give written instruction because if that woman is 25 breastfeeding there is a potential for 100 millirem to the f

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.

(202) 234-4433 WASHINGTON, D.C. 20lX53701 (202) 23tA433

489 1 child she is breastfeeding?

b 2 MR. CAMPER: Well, again, look at --

if you i 4

3 look at the rule, if the dose to a breastfeeding infant or '

4 child could exceed one millisievert, assuming there were t 5 no interruption in breastfeeding, the instruction shall l 6 also include certain things -- guidance on the 7 interruption or discontinuation and information on the 8 consequences of failure to follow. So those --

9 MEMBER SWANSON: One last comment on the 10 previous -- l 11 MR. DeCICCO: The previous one?  :

12 MEMBER SWANSON: Yes. In view of -- if this 13 is the guidance that is going out -- no, the previous one.

14 MR. DeCICCO: Page 7?  ;

15 MEMBER SWANSON: Page 7. Yes. Right. -If 16 this guidance is going out to inspectors, considering our I 17 previous discussion about the consequences of failure to 18 follow the guidance, can we say " consequences" or 19 " rationale"? This is where we do have an opportunity to 20 impact at the inspection level, and I think it's important 21 that that be clarified to the inspectors. ,

i 22 CHAIRMAN STITT: Right. That's discussion we 23 have had, and this is one place where we can try it again 24 in the guidance. All right.

O 25 MR. DeCICCO: The third paragraph talks about NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000A1701 (202) 234 4433

m i

490 1 determination of releasability of the patient by other 2 than the administered activity. Review samples of 3 maintained records -- and these records are patient 4 records -- that indicate the basis authorizing release. I 5 take that back -- not necessarily patient records, but 6 documentation as to the releasability of a patient when 7 other than the administered dose is used for release 8 criteria.

1 9 For instance, if you do a dose rate 10 measurement at some time after administration, that might 11 be either the retained activity or it could be shielding 12 to tissue. So , therefore, you would want documentation of 13 the criteria that you used to release the patient.

14 Is there a record available? For instance, 15 all patients that would be retained in the hospital for 16 radiological purposes would require some determination 17 other than the administered dosage to the individual for i l

18 releasibility. So, therefore, some record would be 19 required as to how you made the determination of 20 releasability. Are the records documented to ascertain 21 the basis of authorized release?

22 For instance, you take a dose rate reading at 23 a meter some time after administration, and you say, " Dose 24 rate is this." Is that above or below what is in 8.39?

25 If it's below, then that's your criteria and you would h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 20006 3701 (202) 23 4 433

~

4 I

491 1 document that. Are the non-medical assumptions used in

("'s 2 the basis for authorizing release reasonable? These are i V 3 primarily in the determination of occupancy factors less I 4

than 0.25, or the biological or effective half-life being 5 used, or some non-medical assumption. And we've put in j l

6 "non-medical" because we don't want to second guess any of I 7 the medical decisions that were made.

I 8 So that would be one way of looking at the 9 compliance and the recordkeeping for determining the i

10 releasibility of the patient. This is, as I said, one of l

11 two record. requirements.

12 CHAIRMAN STITT: Why don't you tell us about ,

i 13 the second record requirement so we can then discuss it as l

(

/ 14 a group?

15 MR. DeCICCO: The second record requirement is 16 a requirement to document instruction to the breastfeeding 17 woman if the TEDE to the breastfeeding infant or child is 18 going to exceed five millisieverts. Is the record 19 available that the instruction was given? And are the 20 records documented to ascertain that the licensee has 21 provided the instruction? And that, again, is the second 22 of the record requirements.

23 And, again, these are something that the 24 inspectc; -

an inspector would take with him or her to a

() 25 licensee and say, "Okay. Do you have a process? Discuss l NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

i (202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

~..-- ,

492 l 1 your program. Do you have records?" And in this case, in l 2 the two record requirement paragraphs, you know, are the 3 records available? and, you know, they should be readily 4

available and clear enough for the inspector to understand l

5 whether the instructions have been provided and whether j l

6 l the criteria for releasability is --

7 MR. CAMPER: So, Joe, in your second point, 8

"Are the records documented to ascertain the licensee has 9 provided instructions?" Now, if I look at D, let's see, 10 what does it say? It says, "Okay. The licensee shall  :

i 11 maintain a record that instructions were provided to a  !

12 breastfeeding woman that the radiation dose ... from 13 continued breastfeeding could result in total" -- that l 14 could be an annotation on a medical record, for example. '

15 MR. DeCICCO: Yes. It could be an annotation 16 on the medical record. It could be an annotation on a 17 separate record that the radiation safety officer might 18 keep.

19 MR. CAMPER: Right.

20 CHAIRMAN STITT: Dan Flynn?

21 MEMBER FLYNN: I had a question about --

22 because this applies to permanent implants also. And, you 23 know, with the 50,000 brachytherapy procedures a year, 24 roughly 5,000 are prostate seed implants, is going to 25 grow, keep on growing, in terms of a facility, let's say, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

493 1 that does 200 prostate seed implants with iodine-125 a

[h 2 year.

3 And let's say the largest implant you do, 4 let's say it turns out to be using 100 seeds of .4 5 millicuries a seed, or 40 millicuries, or 50 millicuries.

l 6 If you can say that you surveyed one patient out of the '

7 200 that had the highest activity, and then -- are you 8 saying that we have to survey every patient or -- it '

9 doesn't.make any sense, because the activities in the 10 patient, in surveying the highest activity patient, you've 1

11 documented what the exposure rate will be at a meter, or 12 you can calculate what it will be.

,.s 13 But to do it for every patient would be very

\s-) 14 laborious, as opposed to, let's say, that's -- so I think 15 in some ways the permanent solid source implant is 16 different than the liquid radioisotope, which has -- you '

17 know, may be or may not be transmitted in milk to one 18 degree or another, with some uncertainty.

19 MR. DeCICCO: I'm almost positive that the 20 reg. guide actually describes that particular scenario, 4

where similar processes or similar procedures can be done 21 22 once and used for similar cases. I guess the problem lies 23 in determining whether they're similar cases or not, as 24 opposed to, for. instance, tissue absorption or because of 25 different patient size or different geometries.

NEAL R. GROSS COURT REPORTERS AND 1RANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000k3701 (202) 234 4433

494 1 But in general, yes, you can use one procedure 2 that has been documented and use that information as a i 3 basis for similar cases.

l 4 CHAIRMAN STITT: But this release rule applies l 1

5 to the case that Dan just brought up, correct?

l 6 MR. DeCICCO: Yes. Yes, it does.

l 7 CHAIRMAN STITT: I was talking about nuclear 8 medicine procedures.

9 Jeff?

10 MEMBER WILLIAMSON: Yes. On page 8, the 11 question is, is there a record available? How would the 12 inspector answer that question, that --

13 MR. DeCICCO? Yes or no.

14 MEMBER WILLIAMSON: Well, record for what? I l 15 mean, the question is you've got all of these conditions 16 that require you to keep a record. How would the 17 inspector verify that the --

18 MR. DeCICCO: Well, I guess it's a two-part 19 look-see. Is there a record available? And then the

, 20 second part, is the record adequate to determine what 21 you're trying to record?

22 MEMBER WILLIAMSON: Well, what would he do?

23 He'd go to the user and say -- or the licensee and say, 24 "Show me the records of all of the patients which had, you 25 know, followed all of these conditions, used an occupancy { }

NEAd. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AWL, N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-3701 (202) 234 4433

495 1 factor less than .25," etcetera. And suppose the guy

,(} 2 says, "We didn't do any that way." Does the inspector V 3 stop then?

i i 4 MR. CAMPER: Well, first of all, he doesn't 5 have to look at-every record. I mean, you could ask the 6 question, do you have -- do you maintain records of the 7 above? The licensee could say yes. The inspector would i l'

8 say, "Could I see a representative sampling of those?

9 Could I see a few of those?" for example. He doesn't 10 necessarily have to see every one.

11 And what was your second point?

12 MEMBER WILLIAMSON: My question is, how does 13 he determine whether the reqv.irement is being followed. l 14 Would he, for example, pick an arbitrary chart of a l 15 patient treated with I-131 and look at what the prescribed 16 activity was and see whether -- you know, look at some

17 chart to see whether they --

1

. 18 MR. CAMPER: Yes, I understand. What you're 19 really asking me is, are the inspectors going to be 20, instructed to evaluate the licensee's evaluation of the i-21 situation and doublecheck their calculations, and so 22 forth. And we're not suggesting that.

23 MEMBER WILLIAMSON: Yes. I guess that's what 24 I'm asking. Are they going to make an attempt to

[-sh 25 independently identify the subpopulation of patients for V

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOEISLAND AVE N.W.

(202) 23M433 WASHINGTON, D.C. 20006-3701 (202) 23 4 433

1 496 l whom records should have been kept in their minds, and 4

1 2 then go back and see whether the records are there or not?

3 MR. CAMPER: No. This is a performance-based 4 approach to the inspection, as identified. I mean, we're 5 not suggesting that. If we were, we would explore that 6 with you.

7 MR. DeCICCO: I guess just to add to that, if 8 I were an inspector and trying to find out whether you had 9 records, I would say, "Do you have any patients that were 10 required to be retained in the hospital?" And if that 11 were the case, then you would have to have a documentation 12 of your criteria for release. And, you know, if you just 13 say " released this day," and didn't have-a record of how 14 that criteria was determined, then I think there would be '

15 an inadequacy in that particular record.

16 MR. CAMPER: I think as a practical matter, 17 Jeff, what's going to happen is most people are going to 18 say, "Yes, I released, and I referred her to Reg. Guide 19 8.39 as the basis." There will be some exceptional cases l 20 where they may step through the process and actually bring 21 to bear all those various technical parameters, which l l

22 could result in a substantially higher amount of retained l l

23 activity.

24 CHAIRMAN STITT: Other comments? Questions?

25 MEMBER SWANSON: I don't know if now is the NEAL. R. GROSS

, COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 2000k3701 (202) 234-4433

497 1 time to bring it up. I think there's an error in the reg.

/"'T 2 guide, draft reg. guide that we got, and I don't know if

\

3 that's an appropriate time to bring it up now or -- if you

4 look at the draft reg. guide, on page 6, 1.4, Special

, 5 Consideration for Breast-feeding Women, it says, "The -

l 6 release quantities in Table 1 did not include i l

7 consideration of the dose to the breast-feeding infant 8 from ingestion of radiopharmaceuticals contained in 9 women's breast milk. If the patient is a breast-feeding 10 woman, it may be necessary to give instructions as a' 1

11 condition for release because the activities in Table 1 12 could cause a dose exceeding five millisieverts." But I A

13 think, in fact, the regulation states that we have to give

'l \

( / 14 instruction that the breast-feeding woman could result in 15 a dose of one millisievert. -

16 MR. CAMPER: Well, let me say this about the 17 draft guide. The draft guide -- the version that you have 18 has been provided only as a reference. The draft guide 19 has undergone substantial change, to include many of the 20 comments that were discussed previously by the committee.

21 You do not have the current version. It is very close to 22 completion, but my colleagues in Research asked me to make 23 sure that if I was going to provide you with this that I 24 brought that point up. So there are a number of errors in 25 the draft guide that you have, but it's only provided as NEAL R. GROSS ..

COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE N.W.

(202) 23 4 433 WASHINGTON, D.C. 20005 3701 (202) 23H433

498 1 background.

2 CHAIRMAN STITT: But Dennis is looking. It's 3 important to know that.

4 Jill?

5 MS. LIPOTI: There is one part of the draft 6 guide which is not being used anymore, but I'll just make 7 a comment on it. At the bottom of page 9, it isn't really 8 emphasized. It's just one bullet in the whole thing. But 9 it talks about precautions to reduce the spread of 10 radioactive contamination. If there were one piece of 11 information out of here that I, as a state radiation 1

12 control program director would want every single person to I 13 do, it would be to emphasize these precautions to reduce 14 the spread of radioactive contamination.

15 I come from a very small state -- the State of 16 New Jersey. Last fiscal year my inspectors responded to 1

17 48 incidents where materials set off the detector at a 18 resource recovery unit where most of the garbage goes in 19 New Jersey. After that detector went off, the garbage had 20- to be unloaded on the floor of the resource recovery 21 facility. My inspectors had to go through a truckload of 22 garbage and identify what set off the detectors.

23 In most cases, it's a diaper from a patient 24 that was released. That is not a threat to public health.

25 And so that could certainly go in with the garbage. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 23 4 433 WASHINGTON. D.C. 20006 3701 (202) 23 4 433

, .. - - = . . . ._. - .

499 2

1 The problem is, what happens in Indiana,

('

't 2 Pennsylvania, where the source was detected because it was

\-

3 in a load of garbage. I cannot not send my inspectors out I

4 on every one of these 48 incidents. Every one of them 5 takes at least one full day, if not one and a half days, 6 and it's a very unpleasant assignment on top of that.

7 So if there is one point that I would like put 8 in red as the issue that I would really like the medical 9 community to emphasize, precautions to reduce the spread l l

10 of radioactive contamination, it's hold on to your 11 diapers, or return your diapers for decay and storage, or 12 not put your diapers out in the regular municipal trash, 13 because they waste time of people who could be spent i i

[T

( ,/ 14 addressing real radiation issues.

j 15 CHAIRMAN STITT: Professor Wagner?

16 MEMBER WAGNER: I suggest you buy a i

17 spectrometer, so that you can identify different types of 18 isotopes within the materials, because if it's technetium-19 99 and you've got that 140 Kv peak there, you can identify 20 what it is and then you can let it decay. You know, this 21 is going to be an ever-increasing problem. But what 22 you' re suggesting, though, is more regulation to contain 23 stuff and make people keep stuff. That ain't going to 24 work either.

f%

i I 25 MS. LIPOTI: May I address just that comment?

V NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 236M33 WASHINGTON, D.C. 2000H701 (202) 234M33

l

, 500 1 We do have a portable gamma spec. It's a little scout 1 2 unit. It's great. But you cannot use it just on the side 3 of the truck to determine the isotope. You really have to 4 get to the stuff. It can still be contained in a garbage 5 bag. You don't actually have to put it up next to the 6 diaper. But it just doesn't work to scan the truck and j

7 use the device. l l

O 8 MEMBER WAGNER: It seems to me that if you can 9 see the thing, that there can be a device created which ,

10 should be able to get the directivity down, so you're not 11 looking at all of the scattered stuff and be able to 12 determine that. That seems to me like it would be --

13 MS. LIPOTI: If you could invent it, I'd buy 14 it.

15 MEMBER WAGN3R: --

a' great entrepreneurial 16 issue for people to try to look at. i 17 MR. CAMPER: Jill has an interesting point 18 because, you know, currently we have the 30 millicurie 19 release limit in 35.75. And, in fact, now the release --

20 the amount of activity that can be released can, in some 21 cases, be substantially higher. And unfortunately, you 22 know, the landfills, because of -- typically of local 23 regulations, certainly not ours, have a zero tolerance for 1

24 acceptance of radioactivity. And so they're setting off l

25 these portable monitors all the time, and that has and NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON. D.C. 20006 3701 (202) 234-4433

501 1 will continue to happen. But so the point is, is

\ /

2 providing these types of instructions is at least a step 3 in the right direction.

4 CHAIRMAN STITT: Are there other comments that 5 the committee wants to get in about the inspection I 6 guidance? Now is your chance, I'm told.

7 MR. CAMPER: Yes, please. I mean, is this  !

8 about the right approach? I mean, we're trying to pursue 9 a performance. I mean, if we kept it at this, ic this a 10 non-offensive way to do it? Is this about the right 11 amount, or too much, or what?  !

l 1

12 CHAIRMAN STITT: I think the group is 13 concerned what they're reading between the lines. And, 14 you know, you can only -- you can say one thing, and they 15 can presume another, and that's what all of that hand-16 waving is over there. I mean, the question is, we see 17 what you're -- we hear what you're saying. What is the 18 actual outcome? What is the function going to be? And I 19 guess time will tell.

20 other comments from the physics side of the 21 table?

22 MEMBER WILLIAMSON: It sounds reasonable, 23 actually, given the way the regulation is written, to be 24 in Part 35. And what you've said about what the 25 inspection guide will contain and how in ideal NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

--l l

502 1

circumstances it might be followed, there is -- you can no 2 doubt detect some suspicion in my mind that rogue 3 inspectors will choose to depart from the ideal standard.

1 4 (Laughte r. )

5 MR. CAMPER: We'll bring them before the ,

6 committee for their tribunal when that happens.

7 (Laughter.)

8 CHAIRMAN STITT: We're going to write that 9 recommendation. Rogue inspectors, I can see it now.

10 Are we done with this topic in the eyes of the 11 committee? All right. Thank you.

12 MR. DeCICCO: Thank you.

13 Let us -- I want to know if the staff wants to 14 do administrative issues. Are we -- it's 12:15.

15 Theresa?

16 MEMBER WALKUP: This is just because I don't 17 know. Is this classified or --

18 CHAIRMAN STITT: I don't think anything we do 19 is classified.

20 MR. CAMPER: No. It's --

21 MEMBER WALKUP: I'm sorry. It's okay --

22 MR. CAMP'ER: -- a matter of public record now.

23 MEMBER WALKUP: Okay.

24 MR. CAMPER: It's no longer classified.

25 CHAIRMAN STITT: We are having paragraphs NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS 1 1323 RHODE ISLAND AVE., N.W.

(202) 234J433 WASHINGTON, D.C. 2000k3701 (202) 2344 433

. . . . -- - - . - ~ - . . - - - .- ._ - . . _

503 1

distributed to us regarding status reports on rulemakings, 2 and we can read these. They are really informational.

3 Torre, Sally, Larry, do you want to talk about 4 administrative issues?

1 5 MR. CAMPER: I think the main -- the big thing l 6 is is -- there are two issues, really. One is we need to I a

7 talk about the timing for the next meeting, and at least

, 8 get some preliminary thinking about, you know, in what l

(

9 window it would be. I taink normally we're in the -- I i

10 believe the April or May timeframe. So I would encoura,ge I 11 you to look at your calendars very quickly.

12 I think normally what we do -- Torre will talk I

. ,-~ . 13 with the Chairman and see what her availability is.

\s , 14 That's the first step in the process, and then we start to l

15 send out some alternative dates to you. So you might 16 begin to look ahead in your calendars now in the April or 17 early May timeframe.

l 18 The second thing is in view of the 19 Commission's preliminary findings, if we assume that those i

20 remain the same, then we certainly could anticipate a l 21 lively agenda for the spring meeting. I think what we'll 22 have to try to do on that agenda is, you know, I think 23 clearly, based upon what I have heard today, is, you know, 4

24 the 1979 medical policy statement would probably be an

()

/*%

25 agenda item with ample time provided, whatever the NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

504 1

Commienion ultimately decides to do in terms of any 2 adjustments to its preliminary findings or, for that 3 matter, if it stays with them.

4 They asked us -- they directed us to ask you 5 for some things. We have started that process. We have 6

certainly made some progress, but we have many miles to go 7 before we sleep, as it turns out.

8 And I think the other thing you ought to be 9 thinking about admi'istratively n is after that meeting, or 10 perhaps in ccnjunction with that meeting, is there a 11 desire by the committee to have a face to face with the 12 Commission? You might recall that the working rule of 13 thumb is is that either the committee or the Commission 14 may request a briefing.

15 Okay. Now, there are some logistical issues 16 to consider in that. For example, we have an annual 17 medical briefing that we present to the Commissite each 18 year. We were going to present that in December. That 19 has been changed recently. It has been delayed to the 20 January / February timeframe. It appears that it's going to 21 be some time in January.

22 There had been some inter-ct expre= sed in 23 perhaps Dr. Stitt, as the chair, participating in that 24 annual briefing. The Chairman of the committee has not 25 always participated in the staff's annual briefing. I l

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 4701 (202) 234 4433

505 1 think it occurred a year or so ago, and it was -- it just i

2

< turned out that there were some circumstances that made  !

\s ' '

l 3 that happen. But it is not a matter of protocol, for j

4 example, that that happen.

5 But certainly, the Chairman may be asked to 6- participate in the upcoming briefing. That is a 7 possibility.

8 But that aside, I guess one of the

• 9 administrative issues that I would ask you to ponder is if 10 we look at head to the next meeting and what the possible I 11 substance of that meeting might be, you should, I would 12 think, consider as to whether or not you would want to 13 brief the Commission. Perhaps as an example, you might 14 want to tie in. If we could put the schedules together, )

15 you might want to tie in an extra day to your meeting 16 where, you know, you would meet for a day and a half, two 17 days, and then the next day you'd meet with the 18 Commission. i 19 I suggest you think about that because I 20 suspect that by that timeframe you would have a lot on 21 your minds, we'd know what the Commission is going to do, 22 we would be discussing some things with you in detail, and 23 you probably would be in a position for a substantive i

24 meeting. But tha -' o entirely up to the committee. I only 25

[w.)\ toss it out as something to ponder from an administrative NEAL R. GROSS

! court REpomy.Rs AND TRANSCRSERS i

1323 RHODE ISLAND AVE., N.W.

i (202) 23M433 WASHINGTON, D.C. 20006 3701 (202) 23M433

m u . .- . ._

M

506 1 standpoint.

~

2 MEMBER WILLIAMSON: Could I ask a question in 3 connection with --

4 CHAIRMAN STITT: Yes, you can ask a question.

5 MEMBER WILLIAMSON: Yes. I would like to know 6 what is the timeframe in which our feedback regarding 7 these direction-setting issues, and sort of these kind of a global philosophical issues, what is the timeframe in 9 which our advice and consensus would be effective?

10 MR. CAMPER: Well, the --

11 MEMBER WILLIAMSON: I guess I'm asking, how 12 would it fit into --

13 MR. CAMPER: No, I understand.

14 MEMBER WILLIAMSON: -- the overall 15 decisionmaking process.

16 MR. CAMPER: I understand. There are two 17 things that would happen. Number one is, as you know, the j 1

18 SA initiative is currently in the process of collecting l l

19 public comment. I don't know -- is. George Pangburn here?

20 MEMBER WILLIAMSON: It ends today, I believe, 21 November 16th.

22 MS. LIPOTI: It's December 2nd.

l 23 MR. CAMPER: The public comment period has l

24 been extended to the 2nd of December. Thank you, Jill.

25 But one of the things that has happened behind{ }

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

507 !

J 1 the scenes in the last few days was a clear interest. I G 2 briefed the Commissioners' assistants, for example, the 3 other day in preparation for this meeting. And it was a 4

clear signal that the Commission is interested in seeing 5 to it that the comments of this committee during this ,

4 6

meeting are considered as part of the comment-gathering i

, 7 process associated with the strategic assessment 8 initiative.

9 Now, so we had that going on, and that 10 deadline in which they're collecting all comments. wnat 11 we will do is we normally process the minutes of the 12 committee. What happens is we prepare a transmittal memo 1 l

13 up through the Executive Director of Operations en route '

C\

) 14 to the Commissioners. We transmit the minutes of the 15 meeting, and we transmit the transcript of the meeting.

16 This particular set of minutes -- and what 17 happens is we work with the Chairman following this 18 meeting, and -- I guess, Torre, it's on a normally, what, 19 two to three weeks, in that timeframe -- we'd wrap up the

20. minutes. Now, we will have to, in this case, not only 21 have the normal operating timeline, which is roughly twa 22 to three weeks, because we go back and forth to the 23 Chairman, noodling the minutes, and so forth. But we 24 absolutely must get them up by that December 2 deadline O 25 for the purpose that I've already said with regards to SA.

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON. D.C. 2000 0 3701 (202) 234 4 433 1

l --.

508 1 What we intend to do on this particular 2

transmittal memo is to call out the fact that certain 3 pages or certain parts of the minutes contain the ACMUI's 4 comments on the DSIs. So having said all of that, they'll 5 have your comments by no later than 2 December.

6 MEMBER WILLIAMSON: No. Here's my concern.

7 I'm sensitive to the fact that we really haven't, you 8 know, completed a thorough assessment of these reports.

9 And the one area where we tried to vote the -- get a 10 consensus, there was fragmentation. We weren't able to 11 pull off a consensus on the rewording of the medical 12 whatever statement.

13 We are going to miss the December 2nd 14 deadline, obviously, because we can't have another 15 meeting. But is there some reason for haste in having 16 another meeting or having some sort of other mechanism for 1

17 trying to achieve a consensus on some of these issues?

l l

18 Because the Commission will be wanting to make some 19 decisions before May.

20 CHAIRMAN STITT: John has a comment.

21 MEMBER GRAHAM: I think -- well, to the extent 22 that the minutes of the ACMUI are going to be put together 23 and sent to them by December 2nd, and there was a specific j 24 motion to it that will be in those minutes, and I 25 certainly detected a strong sense of consensus regarding NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINCTON, D.C. 20006 3701 (202) 234 4433

509  !

t the first component of this committee's concern that the I

1 l

2 Nuclear Regulatory Commission medical policy should be V 3 reviewed.

4 Whether they like the wordsmithing on how it 5 might be changed or not to me is less relevant than if we 6 could receive feedback from staff to the Chairman 7 regarding their reaction to our recommendation that the 8 NRC medical policy should be reviewed. ,

l 9

Then I would recommend that the Chairman would 10 then be authorized, working with staff, to establish a 11 subcomrd.ttee that could review the most germane scientific 12 research and study documentation that would have an impact 13 on how that policy would ultimately be revised, and that

(,) , 14 that could go on before we get here in April, and that 15 there is this compendium of overwhelming documented 16 evidence that shapes the discussion that we have 17 distinguishing where we are in a range between low risk l

18 and high risk.

19 CHAIRMAN STITT: I'm not sure that we need any 20 more meetings. I agree with you that there wasn't a 21 consensue. Well, it was a majority vote. But when you 22 look at the people who made comments, who voted against 23 it, there were no diametrically opposed. The people had 24 qualifications, and I think those -- the folks who voted d 25 against it really --

NEAL R. GROSS -

COURT REPORTERS AND TRANSCRBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 236 4433 WASHINGTON, D.C. 2000 5 3701 (202) 234-4433

510 1 MEMBER NELP: Well, let me give you an 2 example.

3 MEMBER WILLIAMSON: Our very first motion --

4 CHAIRMAN STITT: They commented on our 5 discussion, and the points are very valid as they said. I 6 think it would not be worth our while to try to keep 7 meeting. I feel frustrated because I don't get any sense 8 of what the commission wants, and I don't think I'm the 9 only one in that -- Sally?

10 MS. MERCHANT: I believe that you have met 11 what you were supposed to do at this point, because the 12 Commission asked a very broad question, and it's the one 13 in DSI-7, and DSI-12 builds in with that, and that's, do 14 you think there needs to be a -- do you want it to go 15 away? You know, what is your recommendation? Here they 16 are. One is this, 2 is that, and whether you like it or 17 not, you probably came down very close to 3. And if that 18 is the way t' hat we go, the commission chooses to go, then 19 you will be asked at that point to work on what it should 20 look like.

21 I think it doesn't -- you know, at this point 22 in time, that isn't really a question. You know, you're 23 not being asked to come up with a whole product. Yes, we l 24 want it changed, and here it is. Now, we're not being 25 asked to do that. We're being asked -- or you are being h NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE.. N.W.

(202) 234 4433 WASHINGTON, D.C. 2000 5 3701 (202) 234-4433

I 511 1

1 asked, you know, should it be changed? And you're saying I

/) 2 definitely, it should be changed.

3 And so I think that you're worrying too much 4 about exactly what it should say, because you're going to 5 have plenty of time to work on that.

6 The additional comment I would make as far as 7 getting comments to the Commission, there is one other 8 factor that maybe you weren't aware of, and that's that 9 most of the commissioners' assistants have been in and out 10 over this day and a half. So --

11 MR. CAMPER: Well, let me try to spin it a 12 little differently in terms of what I see as a sense of 13 urgency by Dr. Williamson.

b

(_,/ 14 Where are we? You had discussed as a 15 committee the strategic assessment initiative, DSIs 7 and .

l 16 12. You had provided comments in a timely manner that 17 will be considered as part of the process as the 18 Commissior continues its deliberations.

19 You have a couple of options. One, you could 20 certainly prepare comments as individual members of the 21 Okay?

public. And we encourage you to do that if you 22 desire to do so. The second option would be is that the 23 Chairman could determine if she believes there is a need 24 for a subcommittee meeting to further develop comments, I

7-~s 25 because you -- you know, your argument might be that we t

)

NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS

! 1323 RHOOE ISLAND AVE., N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

. ___ 1 512 l 1 had 0 -- it's a big topic, we had many issues on the  !

2 agenda, we did the best we could in a short timeframe, 3 etcetera, etcetera.

4 There are criteria that apply to subcommittee 1 l

1 5 meetings. They have to be announced. They have to be 6 public, and so forth and so on. You may or may not as a i 7 committee have that sense of urgency. That's for you to 8 decide. l 9 I do think, picking up on what Sally said, it  !

10 certainly is not over. If one were to look at all of the 11 options that face the Commission -- I mean, they presented 12 the five options that they dealt with, which basically 13 range from get out of everything, to get out of medicine l 14 only, to stay in and improve -- you know, the spectrum of ,

15 options. They have indicated a preliminary decision. l 16 No matter which of those options they would 17 choose to follow would require further deliberation with 18 this committee, because even if one took the most extreme 19 example of getting out of materials entirely one would 20 have to discuss how to do that and what the impact would 21 be upon the states and the medical community, etcetera, l

22 etcetera.

l l

23 But if we assume for sake of discussion, 24 because it's the only thing that I can cling to at this 25 moment in time, with the caveat that they certainly can f

NEAL R. GROSS .

COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234-4433 WASHINGTON, D.C. 20006 3701 (202) 234-4433

513 1 change their minds, then we would assume that they will 2 pursue options 2 and 3. And they've challenged us to do x

3 things with this committee, and clearly the Commission did 4 not expect that we would do all of those things in this 5 limited meeting. I mean, everyone knows that.

6 And in addition to the things they challenged 7 us to do, which dealt primarily with' determination of 8 risk-oriented issues, and so forth and so on, what this 9- committee has done I think very interestingly-has picked 10 upon what I believe to be an extremely important way to 11 approach that. And basically, as you're saying in the l l

12 1979 medical policy statement, requires reexamination, )

13 revision, with an emphasis upon the very thing the

(, 14 Commission has asked us to do, and that is risk.

15 And so I think the Commission will read this 16 transcript with a great deal of interest in that regard.

17 And it ain't over, as they say.

18 So the sense of urgency, and have you done 19 enough at this moment in time, is for you to decide. But, 20 again, let me reassure you, it clearly is not over.

21 CHAIRMAN STITT: Let me ask for direction in 22 the spring. Your note says there is going to be a 23 Commission meeting -- medical meeting, a briefing of the 24 Commission on medical issues.

O} 25 MR. CAMPER: Well, we do an annual briefing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON, D.C. 20005 3701 (202) 23M433

514 1 for the Commission, and it was scheduled for the 12th of 2 December, and it has now been delayed. I'm not sure if I 3 fully understand the circumstances, as I've been out of 4 the loop for the last day and a half, but it has been 5 delayed to what appears to be January or February.

6 What I am saying is is that normc11y -- well, 7 from a protocol standpoint, the Chairman of the committee 8 or representatives of the committee have not always 9 participated in that annual medical briefing. We did the 10 last time around for a specific set of circumstances. But 11 there has been some interest expressed in the Chairman 12 participating with the staff in the briefing, and it may 13 turn out that, as I explore this, that the interest in 14 your participating, Madam Chairman, may have been what 15 prompted the delay. I don't know that, but I'll have to 16 explore that, because you weren't available on the 12th of 17 December bec&use of your very busy schedule.

18 CHAIRMAN STITT: I'm probably not --

19 MR. CAMPER: And you probably won't be l .

20 available in January either.

21 CHAIRMAN STITT: No. I require months ahead 22 because --

23 MR. CAMPER: No. We understand.

24 CHAIRMAN STITT: --

I can't leave unless there 1

25 is a body to work for me, and that's one of my { }

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 20005 3701 (202) 234 4433

_ .__ l 515 1 frustrations. And the other committee members, some of '

r'$ 2 them anyway, can't --

\~ Y 3 MR. CAMPER: But from my vantage point, as I 4 observe this, if there is an interest in having the Chair 5 or a representative from the committee participate, I 6 certainly will followup on that, and I may be 7 communicating with you obviously to that end.

8 on the other hand, as I said before, if I look 9 at where you are in the process and what I can foresee 10 coming in the spring meeting, and what I can foresee is i

11 the nature of the agenda, again, I think the  !

12' administrative -- well, the fundamental question is: do 13 you feel that over the next several months, as you l i

14 continue to pursue this issue, once we have Commission 15 direction based upon closure of SA Phase 2, do you feel 16 that you're going to want a briefing with the Commission?

17 That's a question you need to explore as an administrative 18 issue.

19 And if you do, does the timing of the 20 springtime to coincide with your next meeting, does that 21 make sense from an administrative standpoint? Setting 22 aside for a moment what we don't know yet is the degree of 23 interest in your participating, or a representative 24 participating in the briefing that the staff would give on (G; 25 the annual medical use program.

NEAL R. GROSS count REronTEn$ AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 2364433 WASHINGTON. D.C. 200064701 (202) 2344433

516 1 CHAIRMAN STITT: Comments from the group about 2 trying to connect up with the Commissioners in the spring?

3 It's kind of hard to turn down something like that.

4 MEMBER WILLIAMSON: I think i. would be 5 useful.

6 CHAIRMAN STITT: Jeff says it would be useful.

7 Wil?

8 MEMBER NELP: I have one question. Larry can 9 probably answer it. As I go over the Commissioners, two 10 of them are very recently appointed. One is fairly 1

11 recently appointed. And they're probably just getting on I 12 board. Sort of maybe there's an opportunity to influence 13 them. But in reality, is that true? And in reality, do l 14 they keep the same staff that was on board? Do they bring 15 in their own staff and assistants when they come in, or do 16 they inherit what has been here?

17 (Laughter.)

18 I mean, you know - . -

19 MR. CAMPER: Other than that, Mrs. Lincoln, 20 how was the play? Right?

21 (Laughter.)

22 MEMBER NELP: No. I mean, do they take on --

23 MR. CAMPER: Yes, I understand.

24 MEMBER NELP: -- the same personnel that have 25 been here --

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISt.AND AVE., N.W.

(202) 23M WASHMGTON, D.C. 20005 3701 (202) 23M

-1 I

517 1 MR. CAMPER: Well, let me take up -- l

/N 2 MEMBER NELP: -- for a long time?

(-)

l i

3 MR. CAMPER: Let me answer your second <

4 c,uestion first, because this is the easier of the two.

5- The Commissioners have X number of technical 6 staff allotted to them. They may fill those positions

'7 with individuals from within the agency, or for that 8 matter they may bring individuals in from outside of the 9 agency if they choose to do so.

10 MEMBER NELP: So they have that option.

, I 11 MR. CAMPER: They have that option. It's  !

l 12 certainly fair to say most positions of Commissioners' 13 assistants are filled with senior technical people or 14 legal people from within the agency. I'm not aware 15 readily, as I sit here, of someone who came from the l l

4 16 outside. But that's not to say there isn't. They usually '

17 will pick senior people from the staff, but not always.

18 With regards to the capacity to influence, I 19 -- you know, I couldn't begin to comment as to what degree i

20 you can or cannot influence the Commissioners. I do know 21 that the Commissioners are very interested in hearing from 22 organizations. I know, for example, the American College 23 of Nuclear Physicians, Society of Nuclear Medicine, is 24 meeting with one of the Commissioners in the near future, r

(N 25 So they're interested in what's on your minds.

NEAL R. GROSS COURT REPORTERS AND TRANSCRBERS 1323 RHODE ISLAND AVE., N.W.

(202) 23M433 WASHINGTON. D.C. 20006-3701 (202) 23M433

518 j 1 They're interested on what's on this Commission's mind. I 2

know they are interested, they care, they consider, they 3 evaluate. But it's hard for me to weight to what degree 4 you influence. I mean, I don't know.

5 CHAIRMAN STITT: In looking at the 6 biographies, the group is quite an illustrious group of 7 research physicists, radiation biologists. There are no a medical physicists or clinicians. And if I can exhort the 9 group to just hang in there, keep trying, a night's' sleep 10 will help. But we are a very small part of what the NRC 11 does, but we -- medical uses influences professionals and 12 the citizens of the country, and we need to rally around 13 there and --

14 MR. CAMPER: Well, one of --

15 CHAIRMAN STITT: -- with our coffee cups to 16 keep trying.

17 MR. CAMPER: I'm sorry. One of the things 18 that I find very -- I would find very positive from your 19 perspectives as a committee is that if you read the 20 preliminary findings in the options expressed, there is no 21 question, it's explicit, that the staff is to involve the 22 ACMUI and is to solicit specific information for use by l 23 the Commission. So, I mean, they have obviously put you l 24 in the parade as a vital part of it.

25 So I would view that as a very positive thing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.

(202) 234 4433 WASHINGTON, D.C. 2000tL3701 (202) 234-4433

519 1 if I were this committee. I mean, their directions are

/N 2 explicit. Go to the ACMUI and seek certain kinds of l 3 information.  ;

i 4 MEMBER NELP: Do they have a required term of I 5 appointment or is it open-ended?

l 1

6 MR. CAMPER: The Commissioners? )

l l

7 MEMBER NELP: Yes, the Commissioners.

8 MR. CAMPER: The appointments are for five-9 year periods.

• key may be reappointed. A particular l

10 Commissioner may or may not serve five years. The 11 position has a life span, and depending upon one begins to 12 occupy the position, their term could be as much as five 13 years. Sometimes it's only three years or four years, O

(,) 14 depending upon when they are inserted into the position 15 through the approval process.

16 All of the Commissioners at this point are on 17 their first appointment, except Commissioner Rogers, who 18 is on his se'cond five-year term.

i 19 CHAIRMAN STITT: So we like the idea of trying 20 to meet with the Commission during a meeting in Acril or 21 May, which may be very interesting to see if that can come 22 to pass, just as far as timing, getting it scheduled.

23 It's going to have to be done way ahead of time, I 24 presume. I don't know if their schedule allows being

[\

bl 25 scheduled way ahead of time.

NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000H701 (202) N

520 1 MR. CAMPER: Well, from our standpoint, if --

2 what we could do is a placeholder, so to speak. I mean, 3 if the committee decides that you believe that a briefing 4 is desired along that timeframe, we could begin to try to 5 pursue a placeholder on the Commission's schedule.

6 Because you're right, their schedules get booked up pretty 7 fast.

8 CHAIRMAN STITT: Do we want to make a motion 9 along that line?

10 MEMBER WILLIAMSON: I so move.

11 CHAIRMAN STITT: I mean, would you like an 12 active statement from the group on --

13 MR. CAMPER: I think the committee has to 14 decide if you want to do that. i 15 CHAIRMAN STITT: Jeff?

16 MEMBER WILLIAMSON: Yes. I think we 17 definitely should take advantage of any and all 18 opportunities we have to influence the direction of this 19 regulatory agency at this sort of seminal point in its 20 strategic reevaluation. So I'd strongly recommend it.

21 CHAIRMAN STITT: I'm looking for a second.

22 MEMBER FLYNN: I second it.

23 CHAIRMAN STITT: That was a motion. Right, 24 Jeff?

25 MEMBER WILLIAMSON: Was that a motion?

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 234 4433

~ . .- .. .- . __ _ .- .. . . .

521 1 MEMBER FLYNN: Yes.

2 CHAIRMAN STITT: Thank you.

=/ I need a second.

3 MEMBER NELP

Second.

4 CHAIRMAN STITT: Thank you.

5 Discussion? Dan, go ahead.

6 MEMBER FLYNN: Before you make a presentation 7 to them, I think you have to be, you know, very well 8 prepared. And my question would bet should we be doing 'I 9 homework? In other words, for example, high risk / low .

1 10 risk, should we divide high risk / low risk radiation '

. 11 oncology or high risk / low risk nuclear medicine 12 radiopharmacy, and come up with some ideas between now and 13 the next meeting and discuss it prior to briefing the l

14 Commissioners?

15 CHAIRMAN STITT: Well, I think we'd have to j 16 have indications from them as to what their views are. We 4

17 could do a lot of homework that we don't turn in and get 18 any kind of credit for if that's not what they're looking i.

19 for. I've got five graduate school courses that I'm 20 taking right now. I don't need any extra homework. So I 21 t

want to make sure I do it in an effective fashion.

22 Jeff?

23 MEMBER WILLIAMSON: I think it wouldn't be 24 wasted homework. I think if we go -- come to this meeting

25 with the sort of foundation of a consensus built as to NEAL R. GROSS -

COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE.. N.W.

(202) 2364433 VMSHINGTON, D.C. 200054701 (202) 2344433 i

^

522 l 1 what we want to say about risk and the level of -- and 2 scope of regulatory activity in each of our areas, we'll 3 be in a far better position to make a coherent 4 presentation and rapidly go through these things than if 5 we come cold to it.

6 So I would agree with Dan's suggestion. It 7 would be useful to do some homework in advance.

8 CHAIRMAN STITT: And my understanding is we 9 can do that in subcommittee form. It has to be done 10 overtly, according to certain regulations, rather than 11 just sending some stuff around on the Internet.

12 So do you want to vote on this motion, and 13 then we can see what form a subcommittee would take in 14 order to comply with the register requirements.

15 We have a motion to try to arrange our spring 16 meeting around a visit with the Commissioners. Those in 17 favor, raise your hands for Torre. Those opposed? Okay.

18 That sold.

19 And do you want to tell us or let us know how

20. we can hear from you about subcommittees?

21 Certainly, we can -- can we disseminate some 22 ideas freely without being on the --

23 MR. CAMPER: The subcommittee aspect of it can 24 take place either from a request from the staff or the 25 I mean, for example, the last direction of the Chair. f NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20005-370i (202) 234 4 433

523 1 subcommittee meeting that we had was when there was review

/~'N 2 of the guidance documents. Okay? And that was something 3 we asked you to do.

4 You certainly could determine that you wanted 5 a subcommittee meeting to explore / discuss scientific 6 literature, for example, that could be brought to bear in 7 your risk discussions for further use in making

8. recommendations to the Commission. You could certainly do 9 that, and we would just have to do it under certain 10 administrative guidelines that have to be followed.

11 MS. TAYLOR: Excuse me.

12 MR. CAMPER: Torre?

13 MS. TAYLOR: As an initial preparation, the

(h

' \s-)

14 Chair has always -- members can always communicate I l

is individually amongst each other and start putting some 16 ideas together, a plan of attack, what direction we ought 17 to go, start putting some background material together.

18 MR. CAMPER: Right.

19 MS. TAYLOR: The actual preparation -- at the 20 last meeting, we met maybe an hour or so beforehand. This 21 one would be a little bit more elaborate.

22 MR. CAMPER: It's only when you do it as a 23 committee we get into the --

24 MEMBER WILLIAMSON: Can we do

-s

( ) 25 teleconferencing?

NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 2000H701 (202) 234 4 433

- -.-- i l

524 I 1 CHAIRMAN STITT: Sorry. Say again?

2 MEMBER WILLIAMSON: Can we do teleconferencing 3 without running afoul of ethics?

4 MS. TAYLOR: No.

5 CHAIRMAN STITT: No.

6 MR. CAMPER: No. It has to be a noticed 7 meeting available for public attendance.

8 MS. TAYLOR: You could do teleconferencing, ,

9 but you would still have to have the public. .

10 CHAIRMAN STITT: We can converse as 11 individuals through the Internet or the telephone. Who is l

12 not on the Internet? Dan is not. You've got to get with 13 it, Dan. Do I have everybody else's e-mail? Theresa?

14 When does Naomi come on officially?

15 MEMBER WILLIAMSON: Where is she in the 16 process?

17 MS. TAYLOR: I'm still waiting on the SRM, so 18 that we can start the security clearance. And once she ]

19 gets that, and'I do the processing and get the approval, l i

20 then a letter goes out. And so it depends on her i l

21 schedule, the security clearance, and OGC. So it could be.

22 two or three months. It could be next week. l 23 CHAIRMAN STITT: All right. So we've asked l

24 for time with the Commissioners, and I will use the l 25 Internet to talk with you as individuals. ll NEAL R. GROSS -

COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006 3701 (202) 2M

---

l 525 1 MR. CAMPER: If you were to do what you've 2 done in the past, you might recall you had situations 3 where you had a meeting and then you tied on half a day to  ;

4 get ready for the Commission briefing, this type of thing.

5 I mean, you conceivably could be looking at a three-day

~

6 commitment, or you could be looking at a one-day meeting 7 --

the next morning you're working to get ready for a 8 briefing, and then you take part in the briefing, type of 9 thing. You're certainly looking at a two- to three-day --

10 MEMBER NELP: How long does a briefing usually i

11 last? Was it --

12 MR. CAMPER: On something like this, they'd 13 probably give you an hour and a half. l Q 14 CHAIRMAN STITT: John?

l 15 MEMBER GRAHAM: In final followup, given that 16 all of this documentation gets put toget.her by 17 December 2nd, I think what we're asking is, can we get 18 feedback from the Commissioners that would direct the type 19 of subcommittee meeting that might need to take place, 20 where we would brief them formally in April?

21 MR. CAMPER: No, I think that's unlikely.

22 What will happen is'these comments will be considered 23 along with everything else in the SA analysis. All of 24 these comments will be provided to the Commission for j 25 deliberation, but I don't think they are prepared to NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE N.W.

(202) 23N WASHINGTON, D.C. 20006 3701 (202) 234 4433

526 )

i provide feedback specifically to this particular 2 committee.

3 CHAIRMAN STITT: So we could be having our 4 ideas of what we are interested in. They might not have 5 any correlation to what they are interested in, and that's 6 the hazard of a subcommittee.

7 MEMBER NELP: We can take them our message.

8 CHAIRMAN STITT: That is true.

9 MEMBER NELP: Deliver our message to them.

10 MEMBER WILLIAMSON: That's right. We could be 11 proactive.

12 CHAIRMAN STITT: Right. I just brought that 13 up as a comment, that it may be our message, and it may 14 not be related to what theirs is.

15 All right. Larry, are we ready to -- any 16 comments to be made?

17 MEMBER SWANSON: I just have an FYI on status 18 reports.

19 CHAIRMAN STITT: Yes.

20 MEMBER SWANSON: I don't know if you're aware 21 of this or not, but a carbon-13 urea has been approved by 22 the Food and Drug Administration.

23 MR. CAMPER: Are we finished?

24 CHAIRMAN STITT: Go ahead. Yes, John?

25 MEMBER GRAHAM: On that note, I move we I }

NEAL R. GROSS COURT REPORTERS AND TRANSCRl8ERS 1323 RHODE ISLAND AVE N.W.

(202) 2344 433 WASHINGTON, D.C. 20006-3701 (202) 234-4433 9

l l 527 l l

1 adjourn. l I

i' .C i

2 MR. CAMPER: And as the DFO for this meeting,

.\ i 3 I declare the meeting closed.

.i l

4 CHAIRMAN STITT: Thank you. '

i.

5 (Whereupon, at 12:49 p.m., the proceedings in  ;

.i j 6 the foregoing matter went off the record.)

I 7  !

i l

l 8 l 4

9 l

, 10 11 4

12 13 14 15 16 17 18 19 )

20  ;

21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRSERS 1323 RHODE ISLAND AVE., N.W.

(202) 234 4433 WASHINGTON, D.C. 20006-3701 (202) 234 4433

d d

I CERTIFIC&TE

{ This is to certify that the attached proceedings before the United States Nuclear i

Regulatory Commission in the matter of: I l

i i Name of Proceeding: ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Docket Number: N/A Place of Proceeding: ROCKVILLE, MARYIAND were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear i

Regulatory Commission taken by me and, thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.

1. ML ,

c-m R R official Reporter Neal R. Gross and Co., Inc.

i i

Mk l count neponfunsnomascasse tsp AMODEIRAIOaWE luK  !

gm vasesTON.On M N '

o O O-Radiation Interventions and their cost

= "T.:52 m % %xt:25:rE*"""' =

cost / life year saved '

e Automatic collimators on x-ray machines 23,000 e Radon remediation in homes with levels > 8pCi/l 35,000 e Radon remediation in homes with levels > 4pCi/l 140,000 e Radiation levels of 0.3 (vs.1.0) WL at uranium mines 1,600,000 e Radiation standard ALARA for nuclear power plants 2,500,000 e Radionuclide emission control at surface uranium mines 3,900,000 '

l e Radionuclide emission control at f phosphogypsum stacks 29,000,000 e Thin, flexible, protective leaded gloves for

[

radiologists ~190,000,000

Life-Saving Interventions and their cost '

E2 m2E?:::5W ...D:2? Te;T2L~::; --- _

I

. Cost / life year saved e Defibrillators in emergency vehicles for resuscitation after cardiac arrest 39

{

e influenza vaccination for all citizens 140 .

e Federal mandatory motorcycle helmet law 2,000 i

l e Supplemental food for women, infants, and children 3,400 '

e Screen blood donors for HIV 14,000 e Ban asbestos in brakes 29,000 e Smoke detectors in airplane lavatories 30,000 o Seat belts for school buses 2,800,000 e Strengthen buildings in earthquake-prone areas 18,000,000

_ _ _ -------- L

O O Op

~

Intravascular Brachytherapy ,

November 15,1996  :

I James A. Smith Jr. -

e

!=

l I

i

i 1

1 NRC Interim Guidance on Intravascular Brachytherapy .

In April 1996, NRC prepared guidance for research involving intravascular br.achytherapy.' This guidance was published in the

FDA Guide entitled "Intravascular B~rachytherapy - Guidance for .

Data to be Submitted to the Food and Drug Administration in i

Support of Investigational Device Exemption (IDE) Applications".

t t

b I

P-32 lon Imolanted Stents j i

Current regulations,10 CFR 35.400, for brachytherapy do not authorize the use of P-32 for intravascular brachytherapy.

Additionally, if treatment is viewed as brachytherapy, since the sources are not encapsulated, the leaking would result in a  !

misadministration for every treatment. .

It may be possible to. authorize use under 10 CFR 35.300, therapeutic uses of unsealed byproduct material; however, .l '

historically this regulatory authorization has only been used for radiopharmaceutical therapy.

e e i eo

O O O 1

- Options: I o Change the wording under 10 CFR 35.400 to include  !

l intravascular brachytherapy and the use of unsealed and

unencapsulated sources.

t o include a new section under 10 CFR Part 35 to specifically address the use of sealed and unsealed sources for the treatment to prevent restenosis.

o Address each~ individual request on a case by case basis and issue line item authorizations when appropriate.

i o Restrict the investigations under the IDE to broad scope .

medical use licenses.  ;

I l

1 e

Borgess Medical Center I

i in August 1996, Borgess Medical Center, a limited specific licensee, requested to be authorized to perform implantation of  ;

phosphorus-32 (P-32) ion-implanted stent, under an IDE issued to I Isostent. The NRC discussed the issue internally, and determined that for the purposes of the IDE study, the licensee would be authorized by a specific license condition, which references neither 35.400 nor 35.300. At this particular facility, the cardiologist would perform the stent placement, under the supervision of physician authorized users currently authorized on the license for therapeutic uses of P-32.

i -

y 9 9 9 L

o o

O

. Issues That Still Need to Be Addressed:

l 1) Should NRC alter its training and experience requirements to '

allow cardiologists to be named as authorized users for this modality?

2) Should NRC amend its regulations to specifically address the modality of intravascular brachytherapy? ,

c it

3) Should the microcurie range permanent implants require less training than HDR treatments, even if each is designed to deliver a total dose of 10 to 20 Gy to the vessel wall?  ;

1 i

I k i

i b

l l

l l Issues That Still Need to Be Addressed:

l 4) For permanently implanted beta-emitting coated stents, should

NRC use the same criteria for misadministrations as migrated l seeds for the coating or activity that flakes off or leaches out and irradiates other tissues? Or, should NRC view these sources as unsealed sources under 10 CFR 35.300? i

5) Are there unique radiation safety considerations associated with this modality? For example, where is the most likely location within the medical institutions for such implantation? ,

i f

{

\

O O O :

United States kl...'.lNuclear Regulatory Commission EFFECTIVE SECURITY AND CONTROL AT MATERIALS FACILITIES l

Cynthia G. Jones Office ofNuclear Material Safety and Safeguards .

U.S. Nuclear Regulatory Commission l Washington, D.C. 20555

Background & History 1957 -

@20.207 Storage oflicensed material.

Licensed materials stored in an unrestricted are shall be secured against unauthorized removal from the place of ,

storage (22 FR 548) -

1964 -

%20.205 Exemptionsfor radioactive materials packagedfor ,

shipment.

(iv) For containers when they are attended by an individual who takes the precautions necessary to prevent the exposure of any individual to radiation or radioactive materials in  ;

excess of the regulatory limits established by the regulations in ;Part 20; (29 FR 14756) ~

L

Background & History (Continued) 1975 -

An Immediately Effective Rule was issued to strengthen s20.207 to assure that proper controls were maintained over licensed material at all times (40 FR 26679):

%20.207 Storage ofLicensed Material.

(a) Licensed materials stored in an unrestricted area shall be secured from unauthorized removal from the place of storage.

(b) Licensed materials in an unrestricted area and not in storage shall be tended under the constant surveillance and immediate control of the licensee. .

I; y

9 O O i

O T G Background & History (Continued) 1986 -

J

%20.801 Security ofstored material.  !

The licensee shall secure licensed materials stored in controlled or unrestricted areas from unauthorized access or ,

removal. -

%20.802 Control ofmaterial not in storage.

The licensee shall control and maintain constant surveillance ol' licensed material which is in a controlled or unrestricted area and which is not in storage.

r I

__ s . ~. . . : . _ _

Background & History (Continued) 199l Statements ofConsideration:

General Comment - These ; security; requirements provide

" unnecessary restrictions on research."

f Conunission response " Locking radiotracer laboratories when they are not being used is a small nuisance compared to the consequences of unauthorized access to, or theft of, ,

. ' radioactive materials..."

l' i

I:

r e e

\

e .

1

Findings E There appears to be an intent, from 1957 to the present, to  :

allow quantities no matter how small, to remain secure from unauthorized removal.

E Recent high-level inspections at large broad scope and -

research institutions showed that security and control of

radioactive materials were weak.

1 E A review of NRC regulatory guidance (Health Physics Q & As - NUREG/CR-6204) for security & control of byproduct material are inconsistent with current regulations t

• i

.--__--_______--_____-___-------------------2---------------------

~

l _.

Questions E Does the licensee have an audit program? If so, did they find any security or control concerns during their review? Any corrective actions?

E Does the licensee have a current training program? Are the -

authorized users knowledgeable about security and control of radioactive material? If not, this could be aprogrammatic weakness.

E How many labs did the inspector review? If >10-20% oflabs g have a security problem, it could indicate a programmatic problem; if <10%, it could be considered isolated. ,

l l

9 9 -- -

9 l

O C __ ~P r

Questions (Continued)

E Where was the unsecured radioactive material found?

- In a restricted area?

- In a controlled or unrestricted area?

- In waste container? In an unlabeled container? .

E What was the type or quantity of unsecured radioactive material found?

10x,100x or 1000x 10 CFR Part 20 App 3ndix C quantities?

- Stock solution? Or small quantities?

- Actively used in lab equipment / protocol?

- Was it in the form of waste?

i

Suminary E Currently NRC is evaluating existing regulations, guidance, and standard review plans for:

- Security & control of radioactive material (including establishment of restricted, unrestricted, and controlled areas)

E A "one size fits all" approach to security and control issues may not be best for all types oflicensees E NRC is gathering information from licensee workshops to determine how best to proceed with possible revised enl'orcement guidance and/or changes to the regulations.

o e e i

QUESTIONS

. 1. Are there materials that require no security or control  ;

or are adequately controlled by the normal laboratory [

environment? If so, what quantity?-

n

2. What is the basis and the threshold for materials that t require a) no security / controls, b) low, medium, and  ;

high-level security and controls? l

3. What level of detail is needed in guidance from NRC {

to licensees regarding security and control at  !

, laboratory facilities? How specific or prescriptive should any NRC guidance be?

o I

9 QUESTIONS (continued) i

4. What items or issues MUST~be included or addressed in NRC guidance to licensees about security and control of material?

5. What factors should be considered by the NRC in determining the appropriate level of enforcement for security and control violations, and what thresholds, I if any, should exist?  !

• A *J

_ . - - - . _. _ . .. .. - - .. n - )

{

NOV-11-96 16 33 FROM. IDi PACE 2/4

• -.g f g DEPARTMENT OF HEALTH 8. HUMAN SERVICES Public Health Service N, N National Ittstitutes of Health November 8,1996 Bethesda, Maryland 20892 Judith Ann Stitt, M.D., Chair Advisory Committee on the Medical Use of isotopes U. S. Nuclear Regulatory Commission 11545 Rockville Pike Rockville, MD 20852-2738

Dear Dr. Stitt:

I am grateful for the opportunity to submit a statement on behalf of NIH scientists to the Advisory Committee on the Medical Use of isotopes regarding item 4 on the agenda of the Committee's meeting of November 14-15, 1996.

The NRC's requirement for absolute adherence to the enforcement policy on security of tracer levels. of radioactive materials is having a profound impact )

on the conduct of biomedical research at the NIH and at other NRC licensed facilities around the Nation. I hope your committee, in its deliberations on this issue, will consMer the costs, both tangible and intangible, of the current "zero-tolerance" approach of the NRC.

O The attached statement reflects our scientists' concerns in this matter and was developed by Boon Ohock, Ph.D. who, at my request, chairs a special committee of NIH research scientists appointed to examine this issue. The statement represents the thoughtful and careful deliberations of that committee, and I share in ther concems.

Sincerely, h

Michael Gottesman, M.D.

Deputy Director for intramural Research Enclosure Bob Zoon Radiation Safety Officer National Institutes of Health 301-496-2254 l

l O

_. _ e ==._u" -

3 NOV-11-96 16:33 FROM ID: PAGE 3/4 Statement from the National Institutes of Health Radionuclide Security Working Group for the Advisoly Committee on the Medical Uses of isotopes in response to NRC's call for strict security measures on radionuclides, the scientific community at NIH has taken steps to address both the NRC concerns and NIH researchers' laboratory needs. The community aims to make sure that radionuclides are effectively guarded while allowing research to be conducted efficiently and safely. Much time and effort have been spent to deal with this problem by the researchers, administrators, and staff of the Radiation Safety Branch. Furthermore, research activity in a significant number of laboratories was halted due to suspension of the use of radioactive materials, including research in the laboratory of a Nobel laureate.

The NIH Radienuclide Security Working Group, a subcommittee of the NIH Radiation Satety Committee, was formed by Dr. Michael Gottesman, NIH Deputy 4

Director for Intramural Research, in order to ensure the participation of bench scientists in finding a reasonable solution to the security problem. The Working Group wishes to express its concem about the NRC's zero-tolerance radionuclide security policy to the Advisory Committee on the Medical Uses of isotopes.

1 It is well recognized that the majority of the radionuclides used for medical research in the laboratory, due to the limited quantities and the nature of these isotopes. are not as harmful as many chemicals, such as cyanide, protease inhibitors, toxins, etc., one encounters in the laboratory. Furthermore, it is impractical and not cost effective to achieve an absolutely risk-free environrnent. Even with the current stringent locked-door policy, one cannot prevent someone from intentionally contaminating another person, as was the case in Building 37 at NIH. However, the Group agreed that zero tolerance of unauthorized access to radioactive materials should be the guiding principle for handling radioisotopes at the NIH. At the same time, the Group recognized that absolute adherence to this principle would, in practice, result in increased risks to researchers and risk of contamination to both the working area and the researcher because locking and unlocidng doors while carrying radioactive materials increases the risk of accidents and the possibility of contamination.

j in addition, such extreme security measures as the current locked-door policy will reduce scientific exchange among scientists because locked doors impede

passage between laboratories, and it also impedes access, if needed, for medical and/or fire emergencies. Therefore, we strongly believe that one should reconsider the current NRC security policy to take into secount its risk-benefit ratio and reasonableness. To facilitate research and to reduce the possibility of contamination and safety risks to researchers, we believe

exemptions should be made to the current locked-door policy when low levels of radioactive materials, such as a few times the Appendix C level (Appendix C levels do not require posting the caution signs according to 10 CFR 20.1902,

, - _ _ _ -  :~--.. - n. -. - ,.---~- -.

- . - - t ,

NOV-11-56 16 34-FROM , . ID PAGE 4/4 O 20.1903, and 20.1905), are used. In addition, excluding unsecured source vials, it is unreasonable to require locking doors to rooms that house dry radioactive waste, liquid radioactive waste that contains very diluted materials, columns that contain either trace amounts of radioactive materials or radioactiva compounds covalently linked to the solid matrix, or instruments for monitoring radioactivity. In essence, while it is essential to lock-up the source vials, it is unnecessary and counterproductive to require locking doors for samples with low levels of radioactive materials, and low level solid waste and highly diluted liquid waste.

Prepared by Boon Chock, Ph.D, November 8,1996

DR. SRIRLEY ANN JhCESON The Honorable Dr. Shirley Ann Jackson, Chairman of the U.S.

Nuclear Regulatory Commission, is a theoretical physicist. She was sworn in as a Commissioner on May 2, 1995 and assumed the Chairmanship two months later, on July 1. Prior to joining the NRC, she had extensive experience as a university professor, research scientist, consultant and corporate director.

j A native of Washington, D.C., she graduated from Roosevelt High School in 1964,'as class valedictorian. Matriculating at Massachusetts Institute of Technology in Cambridge, Mass., she  ;

earned a Bachelor of Science degree in physics in 1960 and a  !

Ph.D. in the field of theoretical elementary particle physics in  :

1973.

From 1991 to 1995, Dr. Jackson was Professor of Physics at  !

Rutgers University in Piscataway, N.J., serving concurrently as a '

consultant in semiconductor theory to AT&T Bell Laboratories in Murray Hill, N.J.

i For 15 years, from 1976 until 1991, Dr. Jackson conducted j research in theoretical physics, solid state and quantum physics, and optical physics at AT&T Bell Laboratories.

Dr. Jackson is a Fellow of the American Academy of Arts and

, Sciences, is a Fellow of the American Physical Society, and is a j member of a number of other professional organizations.

! Dr. Jackson holds four honorary doctoral degrees from:

Bloomfield College (NJ), Fairleigh Dickinson University (NJ),

l Cheyney University (PA) and Villanova University (PA). In 1993 i she was awarded the New Jersey Governor's Award in Science (New

{ Jersey's highest award to a State citizen).

She has served on'the board of directors of Public Service l Enterprise Group and its subsidiary, Public Service Electric and i Gas Company, Sealed Air Corporation, CoreStates Financial Corporation, CoreStates New Jersey National Bank,' and New Jersey

, Resources Corporation.

i She is a Life Member of the M.I.T. Board of Trustees. She

! has served on the Secretary of Energy's Task Force on the future

. of Department of Energy National Laboratories, served on

research councils of the National Academy of Sciences and on the

! Advisory Council of the Institute of Nuclear Power Operations

! (INPO). Dr. Jackson has also served on a number of high level

commissions in the state of New Jersey.

I Dr. Jackson has achieved a number of firsts in her career.

! She was the first African-American woman to receive a doctorate

from M.I.T.--in any subject; she was the first African-American j- to become a Commissioner of the NRC; she was the first woman and 1

i

I n- .__- _ i the first African-American to serve as Chairman of the Commission.

Dr. Jackson is married to Dr. Morris A. Washington, also a physicist. They have one son, Alan.

f 1

O l

I O

l

m e

Q EEIDfETE C. ROGERS Kenneth C. Rogers was sworn in for a second five-year term as a member of the Nuclear Regulatory Commission on June 12, 1992. Before his first-term nomination by President Reagan and confirmation by the Senate in 1987, Dr. Rogers served as president of Stevens Institute of Technology for 15 years.

He joined Stevens in 1957 following research appointments at Cornell University. At Stevens he served the college as a professor, head of the physics department, dean of the faculty and acting provost before becoming its president in 1972. He has

• held appointments at Princeton University and the City University -

of New York concurrent with his Stevens positions. In 1987 he was designated President Emeritus at Stevens. '

A physicist by training, Dr. Rogers' technical areas of expertise include plasma physics, particle accelerators, optical spectroscopy, elementary particle physics and nuclear instrumentation. He is the author of more than 30 technical papers, and two patents.

Dr. Rogers was appointed by the Governor as a member of the New Jersey Commission on Science and Technology and is a member of numerous professional societies, including the American Physical Society and the American Nuclear Society, and is a ,

Senior Member of~the Institute of' Electrical and Electronics Engineers. He is a Fellow of the American Association for the Advancement of Science.

1 He has served as a Director of the Public Service Enterprise l Group (formerly Public Service Electric and Gas Company c New  !

Jersey) and was a charter member of the Board of Director's Nuclear Oversight committee. He has been a Director of the First Jersey National Bank as well as a Trustee of the Christ Hospital, Jersey City, NJ; the Association of Independent Colleges and Universities in New Jersey; the Independent College Fund of New Jersey; and the Hoboken (NJ) Chamber Orchestra.

l 4

6

,n- - . . , ,

2 He received a bachelor of science degree in physics from St.

Lawrence University (1950) and a master of arts degree in physics (1952) and doctor of philosophy degree in physics (1956) from '

Columbia University. He was awarded an honorary doctorate degree by St. Lawrence University in 1983 and by Stevens Institute of Technology in 1987. He was the first recipient of the Hudson County (NJ) Humanitarian Award of the National Conference of Christians and Jews in 1985.

Born in Teaneck, New Jersey, Dr. Rogers and his wife Katharine have three children.  :

l

)

l 1

O O

.__._..m _ __._ ~ __-.. _ _ _ _ , _ __ _ -. _ .. _ . _ _ _ _ _. _

4 GRETA JOY DICUS 1

! The Honorable Greta J. Dicus, Commissioner of the U.S.

l Nuclear Regulatory Commission (NRC), is a radiation biologist 4

from Arkansas. She was sworn in as a Commissioner on February 15, 1996. Prior to joining the NRC, Ms. Dicus has had j extensive experience as a health physicist, research scientist,

j. medical school instructor, radiation health director, and j corporate board member.

l Ms. Dieus was confirmed by the U.S. Senate as a member of the Board of Directors of the United States Enrichment l Corporation from March 1994 to March 1995.

From 1980 to 1995, Ms. Dicus worked in progressively

{ responsible positions in the Division of Radiation Control and

Emergency Management at the Arkansas-Department of Health. She j was Chief of Licensing from 1982 to 1984 and was Director of the 1

Division for nine years thereafter.

4 i Concurrently, from 1991 to 1993, she served as Chairman of I

the Central Interstate Low-Level Radioactive Waste Commission.

She also served on the Southern States Energy Board's (SSEB)

Advisory Committee on Transportation of Radioactive Materials and l the SSEB's TRU Waste Working Group.

1

For 16 years, from 1961 to 1977, Ms. Dicus conducted

research in radiation health effects at Harvard Medical School,

! Rice University, the University of Texas, and Southwestern 1 j Medical School. She published several papers detailing her  ;

i studies. During this time period, Ms. Dicus also instructed 1

(

nursing students in bialogy, from 1974 to 1977, at Garland County

community College and graduate students in radiobiological research, from 1966 to 1968, at Southwestern Medical School.

l An Arkansas native, Ms. Dicus was educated in Texas. Ghe

graduated with a Bachelor of Arts degree in biological sciences j i from Texas Woman's University in 1961 and earned a Master's Degree in radiation biology from the University of Texas j Southwestern Medical School in 1967. i Among her appointments, Ms. Dicus has served as the Arkansas Department of Health Emergency Services Liaison Officer to Arkansas' Office of Emergency Services, Arkansas' Liaison with j the NRC, Alternate Commissioner and later as Commissioner of the

)

i d

(

}

j.

, . . ~ . . -.w,- ,n

-=- -,

s Central States Low-Level Waste Compact Commission, and member of  !

the Governor's Low-Level Radioactive Waste Advisory Group.

Ms. Dicus has been a member of the Health Physics Society, Sigma Xi, and the Conference of Radiation Control Program {

Directors.

1 O

i l

4 9

1 f

i js COMMISSIONER NILS J. DIAS

[ Dr. Nils J. Diaz was sworn in as a Commissioner of the Nuclear Regulatory Commission on Aug. 23,.1996, after a j distinguished career spanning a quarter century as an educator,

research scientist, consultant and entrepreneur in such fields as

! nuclear engineering, nuclear power sources in space and medical

and industrial applications of radioisotopes.

1

Before joining the NRC, Dr. Diaz was a professor of nuclear

engineering at the University of Florida and director of the j Innovative Nuclear Space Power.and Propulsion Institute, a j national consortium of universities and industry, which he

founded. He also was president of Florida Nuc2 ear Associates, j Inc., a high technology research and consulting firm.

J For one year, in the early 1980's, he served abroad as the

Principal consultant to Spain's Nuclear Regulatory Commission, j and has consulted for the governments of Mexico, Venezuela, j Brazil and Argentina.

-j Dr. Diaz received a Bachelor of Science degree in Mechanical Engineering from the University of Villanova, in Cuba and both a ,

j Master of Science and PhD degrees from the University of Florida j in nuclear engineering sciences. From 1971-1983, he held a i senior nuclear reactor operator's license from the NRC.and worked on Medical Physics at Vanderbilt University and the University of Miami hospitals, among others.

Before joining the NRC, Dr. Diaz was actively involved in i research of power sources in space, advanced energy conversion, advanced space propulsion, and in developing gamma ray spectroscopy for the detection and location of flaws in materials.

l e

- . . _ . = . ~ . . - . . - - . . - , ~ . . .

-. - a.u _ . -

i i

1 COIDtISSIONER EDWARD McGAFFIGAN, JR.

f i

1 Edward McGaffigan, Jr. was sworn as a Commissioner of the

} Nuclear Regulatory Commission on August 28, 1996. Prior to that

time, he was a senior policy advisor to Senator Jeff Bingaman (D-NM), and on the Senator's staff since February 1983. Throughout the thirteen and one-half years, he supported the Senator's work on defense policy, technology policy, personnel and acquisition j reform, and nonproliferation and export control policy.

I Mr. McGaffigan was a member of the Foreign Service for almost seven years prior to joining Senator Bingaman's staff.

From February 1981 to February 1983 he served as a-senior policy l analyst and then assistant director in the White House Office of i Science and Technology Policy, where he oversaw international scientific cooperation and export control matters. During much of this period he held a dual appointment on the National Security Council staff.

Previously, Mr.'McGaffigan had carried out various assignments within the State Department daaling with U.S.-Soviet relations and politico-military issues. In his only overseas assignment he was stationed as a science attache in the U.S.

Embassy in' Moscow from July 1978 to April 1980. He reported on Soviet energy and atomic energy developments and managed

(' bilateral science cooperation in those and other areas.

at the time proficient in Russian.

He was Prior to joining the Foreign Service in May 1976, Mr.

McGaffigan worked at the RAND Corporation on evaluating Japanese science and technology and at the Arms Control and Disarmament Agency on strategic arms control issues.

Mr. McGaffigan grew up in Boston, where he attended Boston Latin School and became valedictorian of his graduating class.

He majored in physics at Harvard, where he received his bachelor's degree in 1970 (summa cum laude). He was elected to Phi Beta Kappa his junior year. He holds master's degrees in physics from California Institute of Technology (1974) and in public policy from Harvard's Kennedy School of. Government (1976).

He won a Harvard National Scholarship, a Sheldon Travelling Fellowship, a National Science Foundation Fellowship, a Woodrow Wilson Foundation Fellowship, a Millikan Fellowship, and a Harvard National Graduate Fellowship during his academic career.

Mr. McGaffigan is married and has two children. He has been active in coaching youth soccer and basketball.

\

4 i

l l

O O Ow,

,f- - u ,,

[ } United States

• %,,,,,/ Nuclear Regulatory Commission INSPECTION GUIDANCE FOR FINAL PATIENT RELEASE RULE November 15,1996 Joseph E. DeCicco Division ofIndustrial and Medical Nuclear Safety U.S. Nuclear Regulatory Commission Washington, D.C. 20555 I

Os O O '

! s United States -

\,,,,,,) Nuclear Regulatory Commission s 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.

l 35.75(a) i The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure .

to the released individual is not likely to exceed 5 millisieverts (0.5 rem).'

t

' Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," describes methods for calculating doses to other individuals and contain tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).

l

,p-~ \

{ } United States  ?

l *%,,,,,/ Nuclear Regulatory Commission \

35.75 Release of individuals containing l

radiopharmaceuticals or permanent implants.

l

! 35.75(b)

The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as l

reasonably achievable if the total effective dose equivalent to  ;

any other individual is likely to exceed 1 millisievert (0.1 rem).  !

l 1

l t

O O -_

O l

9. , ~ , O O

! q United States

%,,,,,) Nuclear Regulatory Commission s 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.

35.75(b)- (con't)

. . . If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include (1) guidance on the interruption or discontinuation of breast-feeding and (2) -

1 information on the consequences of failure to follow the guidance.  :

1 3

1.

f,  %,,

! y United States-

\,,,,,,/ Nuclear Regulatory Commission 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.

$ 35.75(c)

The licensee shall r'taintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated (1) using the retained activity rather than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the biological or effective half-life, or (4) considering the shielding of tissue.

~

9 O G i

O -

O O s.,,

! y United States

\ ,,,,./ Nuclear Regulatory Commission 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.

! 35.75(d)

The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).

5 i

,f-~%

l } United States  !

• \, ,, , , ) Nuclear Regulatory Commission j

Performance Based Inspection Against f 35.75(a)

Ask licensee to describe how it demonstrates compliance with -

authorizing release of pa'tients administered radiopharmaceuticals k

Is there a process to determine if TEDE to other individuals '

not likely to exceed 5 millisieverts?

Is there a process to determine if maximally exposed -

individual is a breast-feeding infant or child?

Is there a process to determine the dose to the breast-feeding infant or child?

._______.._.___________._.)

O O O ,

,p ~s.,, '

! United States

\,,,,)} Nuclear Regulatory Commission Performance Based Inspection Against f 35.75(b)  !

e Review instructions provided to the released individual any I other individual likely to exceed 1 millisievert (0.1 rem) TEDE Is there an instruction written or a sample of the written instruction available?

Is there instruction available for the individual that is breast-feeding an infant or child if dose to infant or child could exceed 1 millisievert (0.1 rem)?

Is there guidance on interruption of breast-feeding and the i consequences of failure to follow the guidance?

./ ~%,,

{ }

United States

• %,,,,,,/ Nuclear Regulatory Commission Performance Based Inspection Against f 35.75(c?

Review samples of maintained records that indicate the basis for authorizing release of individual when retained activity, occupancy factor less than 0.25 at 1 meter, biological or effective half-life, or shielding by tissues is used Is there a record available?

Are the records documented to ascertain the basis for authorizing release?

Are the (non-medical) assumptions used in the basis for authorizing release reasonable?

~

9 O 9

O s O O

(. .

} United States

• %,,,,,/ Nuclear Regulatory Commission Performance Based Inspection Against f 35.75(d)

Review samples of maintained records that indicate instructions l were provided to a breast-feeding woman if dose to the infant or child from uninterrupted breast-feeding could result in a TEDE 1 exceeding 5 millisieverts Is there a record available?

9 Are the records documented to ascertain that the licensee has provided instructions?

I l

l 9

[

-- - - . v~.--

m a

5A h

V STATUS REPORTS ON RULEMAKINGS AND REGULATORY GUIDANCE OFFICE OF NUCLEAR REGULATORY RESEARCH November 15,1996 Patient Release Rule The Commission approved in October 1996 a final rule to amend 10 CFR Parts 20 and 35 concerning the criteria for the release of patients who has been administered radioactive material. The final rule should be pub!ished in the Federal Register around February 1997 (effective date would be 120 days following publication). A regulatory guide will be published at the same time as the rule. A comprehensive regulatory analysis will als'o be published as a NUREG' report (NUREG-1492). The final rule clarifies that 10 CFR Part 35 governs patient release, permits a maximum likely total effective dose equivalent (TEDE) of 500 mrem (5 mSv) to an individual exposed to a released patient, requires instruction be provided if TEDE is 100 mren. 'l mSv) or more to the individual, requires records under certain conditions, and requirt;, additionalinstructions for a patient who is breast-feeding a child.

O Tri-Med Carbon-14 Petition in response to a petition for rulemaking from Tri-Med Specialties, Inc., on 0 :tober 1, 1996, the NRC staff sent a draft rulemaking plan to the Agreement States for comments. -

The comment period closed on October 31,1996. Nine comment letters have been received. The NRC staff is currently analyzing these comments. A final rulemaking plan will be submitted to the Commission for approval in the near future. ' The petitioner i

requested that the NRC amend its regulations to allow any physician to use capsules  !

containing one micro-curie of C-14 uros for in vivo diagnostic testing.  !

l Unauthorized Use of Licen==d Radioactive Material l The NRC staff has sent the draft final rule language to the Agreement States for further comment. Eleven comment letters were received. The NRC staff is currently preparing a paper, along with a summary of all the comments, to forward the final rule to the

, Commission for approval.

Radionharmacy Raoulatorv Guidas The draft regulatory guides have been prepared and they are under review. These guides will be published for comment when the review is completed.

O O