NANCY LEE & ASSOCIATES

Certified Verbatim Reporters

P. O. Box 451196

Atlanta, Georgia 31145-9196

(404) 315-8305

THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

CENTERS FOR DISEASE CONTROL AND PREVENTION

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

convenes the

ADVISORY BOARD ON

RADIATION AND WORKER HEALTH

VOLUME II

The verbatim transcript of the Meeting of the

Advisory Board on Radiation and Worker Health held

at the Washington Court Hotel, Washington, D.C.,

on Thursday, February 14, 2002.
2 

C O N T E N T S

VOLUME II

February 14, 2002

PARTICIPANTS (by group, in alphabetical order) ..... 3

REGISTRATION AND WELCOME 

Dr. Ziemer ...................... 5

ADMINISTRATIVE HOUSEKEEPING

Ms. Homer ...................... 6

BOARD WORK SCHEDULE

Mr. Elliott, Ms. Homer ................ 8

BOARD DISCUSSION/DEVELOPMENT OF COMMENTS ON

DOSE RECONSTRUCTION RULE (42 CFR PART 82) ........ 24

Motion and Vote ................. 44, 44

Motion and Vote ................. 46, 46

Motion and Vote ................. 51, 51

Motion and Vote ................. 53, 55

Motion and Vote ................. 57, 64

Motion and Vote ................. 63, 64

Motion and Withdrawal .............. 66, 71

Motion and Vote ................. 71, 72

Motion and Vote ................ 74, 112

PUBLIC COMMENT PERIOD

Mr. Richard Miller .................. 84

CONTINUATION OF BOARD DISCUSSION ............ 90

Motion and Vote ................. 90, 99

Motion and Vote ................ 100, 106

Motion and Vote ................ 107, 107

Motion and Vote ................ 108, 108

ADJOURN ....................... 120

CERTIFICATE OF REPORTER ................ 121
3 

P A R T I C I P A N T S

(By Group, in Alphabetical Order)

ADVISORY BOARD MEMBERS

CHAIR

PAUL L. ZIEMER, Ph.D. 

Professor Emeritus

School of Health Sciences

Purdue University

Lafayette, Indiana

EXECUTIVE SECRETARY

LARRY J. ELLIOTT

Director, Office of Compensation Analysis and Support

National Institute for Occupational Safety and Health

Centers for Disease Control & Prevention

Cincinnati, Ohio

MEMBERSHIP

HENRY A. ANDERSON, M.D.

Chief Medical Officer

Occupational and Environmental Health

Wisconsin Division of Public Health

Madison, Wisconsin

ANTONIO ANDRADE, Ph.D.

Group Leader, Radiation Protection Services Group

Los Alamos National Laboratory

Los Alamos, New Mexico

ROY LYNCH DeHART, M.D., M.P.H.

Director

The Vanderbilt Center for Occupational and Environmental

Medicine

Professor of Medicine

Nashville, Tennessee

RICHARD LEE ESPINOSA

Sheet Metal Workers Union Local #49

Johnson Controls

Los Alamos National Laboratory

Espanola, New Mexico
4 

SALLY L. GADOLA, M.S., R.N., COHN-S

Occupational Health Nurse Specialist

Oak Ridge Associated Universities

Occupational Health

Oak Ridge, Tennessee

JAMES MALCOM MELIUS, M.D., Ph.D.

Director

New York State Laborors’ Health and Safety Trust Fund

Albany, New York

WANDA I. MUNN

Senior Nuclear Engineer (Retired)

Richland, Washington

ROBERT W. PRESLEY

Special Projects Engineer

BWXT Y-12 National Security Complex

Clinton, Tennessee

GENEVIEVE S. ROESSLER, Ph.D.

Professor Emeritus

University of Florida

Elysian, Minnesota

STAFF/VENDORS

CORRINE HOMER, NIOSH

TED KATZ, NIOSH

MARIE MURRAY, Writer/Editor

KIM NEWSOM, Certified Court Reporter

AUDIENCE PARTICIPANTS

RICHARD MILLER 
5 

NANCY LEE & ASSOCIATES

1 P R O C E E D I N G S

2 9:00 a.m.

3 DR. ZIEMER: Good morning again, everyone.

4 We'll resume deliberations of the Advisory Board

5 on Radiation and Worker Health. 

6 (Comment off the record)

7 DR. ZIEMER: For members of the public,

8 again we remind you that if you wish to make

9 public comment during the meeting today, there is

10 a sign-up sheet in the foyer or the entryway.

11 Please sign up.

12 Also, those members of the public who wish

13 to have copies of the minutes of this meeting,

14 there is a sheet for signing up to make such a

15 request for those minutes.

16 On our agendas, as distributed and as

17 published, we always have a footnote that says

18 agenda items are subject to change as priorities

19 dictate. And based on that footnote, I will

20 exercise the Chair's prerogative to rearrange the

21 schedule somewhat. 

22 We have at the front end here some

23 administrative housekeeping things that we want

24 to take care of, and then it would seem

25 appropriate to also handle the Board work
6 

NANCY LEE & ASSOCIATES

1 schedule items at that time. So we'll move the

2 10:30 item, Board work schedule. We'll move that

3 up and do that immediately following the

4 administrative housekeeping things. That will

5 allow us, then, basically the rest of the morning

6 to work on the development of the Board's

7 comments relating to the dose reconstruction

8 rule.

9 So without objection, we'll make that

10 rearrangement of the morning agenda.

11 There will also be time for public comment. 

12 And depending on how far we get this morning, we

13 will then take a look at the afternoon agenda.

14 So let us begin with these housekeeping

15 items, and Cori, if you will come at this time

16 and take care of the administrative housekeeping

17 matters, and then we'll -- Larry will join us

18 with some additional materials.

19 MS. HOMER: Thank you. 

20 Good morning, ladies and gentlemen. I just

21 wanted to update you on your salary and travel

22 pay issues. I wanted to let you know that your

23 salary should be direct deposited into your

24 accounts tomorrow. I don't have in front of me

25 the number of days you'll be paid for. If you
7 

NANCY LEE & ASSOCIATES

1 have any questions on that you can just give me a

2 call. It will be less taxes. And if you have

3 forwarded your voucher information to us, myself

4 or Nichole, then it's either being worked on or

5 it's been signed and is going to be reimbursed.

6 I do want to ask if any of you have any

7 questions at all about how you're paid, how

8 you're reimbursed, anything about your travel

9 issues, per diem, how that's paid?

10 (No response)

11 MS. HOMER: I know some folks have asked

12 about per diem for travel.

13 MS. MUNN: Cori, will we be getting some

14 sort of document in the mail --

15 UNIDENTIFIED: Use your mike, Wanda.

16 MS. MUNN: Will we be receiving some sort of

17 written information about itemization of our per

18 diem and travel funds?

19 MS. HOMER: That will come on your travel

20 voucher. When that comes to you, for those of

21 you who have seen one or have signed one, your

22 voucher will come to you for signature and

23 dating.

24 MS. MUNN: Okay.

25 MS. HOMER: And if you have any questions at
8 

NANCY LEE & ASSOCIATES

1 that time, looking it over, you can call myself

2 or Nichole on that. You will also be getting, as

3 soon as I have it, your earnings and leave

4 statement for salary, and that will tell you how

5 much was deposited into your account. If you

6 have not received that in your account, please

7 call me as soon as you know. That way I can go

8 back and check when it was paid, what day it was

9 supposed to have been deposited, and we can get

10 that taken care of as quickly as possible.

11 Also, for the time you spent reviewing the

12 technical guidelines, if you could let Larry know

13 how much time you spent. 

14 And any other questions?

15 DR. DEHART: And the time on the phone call?

16 MS. HOMER: Yes, the time on the phone call

17 as well.

18 I guess that'll be it.

19 DR. ZIEMER: Okay. Larry, you have

20 additional items?

21 MR. ELLIOTT: Yes. Let's do it the way we

22 did last meeting. If you'll just jot me a note

23 with the number of hours of prep time, then I

24 sign off on that note and hand it over to Cori to

25 take care of your salary for prep time for the
9 

NANCY LEE & ASSOCIATES

1 teleconference. And we know what the

2 teleconference was; you'll get that covered. And

3 then your preparation time for yesterday and

4 today's meeting.

5 I think there was one question, and I'm not

6 sure everybody got an answer to. That was how do

7 I know -- this came up yesterday -- how do I know

8 when my salary gets deposited, and how do I know

9 when my travel voucher or my travel expense gets

10 deposited to my account? When you sign off on

11 your travel voucher, make note of -- and you

12 should get a copy of this for your own records --

13 but make note of what that dollar value is, and

14 that's what will be actually added to your

15 account for your travel. But your salary will

16 not be X number of days times your salary; it'll

17 be minus the tax. So that'll be a figure that we

18 can't predict for you.

19 The other thing, under the Board work

20 schedule, we -- as Dr. Ziemer used his

21 prerogative to move this up, we need to talk

22 about the -- we tentatively have March 25th and

23 26th set aside in your calendars for the next

24 meeting. What work do we have for that meeting,

25 and do we need to have that meeting? Should we
10 

NANCY LEE & ASSOCIATES

1 postpone that meeting? I think that's a topic of

2 this agenda item at this point in time.

3 It's very unlikely that we would have the

4 Special Exposure Cohort procedures ready for

5 review in March, at that time frame. It's just

6 too hard for me to predict right now. The only

7 thing I would see that the Board could work on in

8 March would be to come together to discuss or to

9 decide how to conduct its review of dose

10 reconstructions.

11 I would suggest to you that the review of

12 dose reconstructions would probably not start,

13 however, until early fall; late, late summer,

14 early fall. I think it's important for us to

15 build a completed case load of those for you to

16 sample from. I don't think you want to start out

17 looking at the first 100 or so, or first ten that

18 come out of the gate. But I think you need to

19 come to grips and decide, discuss and decide how

20 you want to approach setting up a review of dose

21 reconstructions.

22 I know there were several other things that

23 were proposed yesterday for presentations to the

24 Board, and we certainly are willing to

25 accommodate those interests. But I would ask
11 

NANCY LEE & ASSOCIATES

1 that you consider our preparation for those kind

2 of presentations at this point in time takes

3 staff away from completing some of their

4 necessary work that we have in order to try to

5 achieve our goals. And we can certainly get to

6 those things later on, but that would be just my

7 suggestion for your consideration.

8 So I'll turn it over to the Chair, and you

9 should discuss how you want to proceed.

10 DR. ZIEMER: First of all, let me suggest

11 something here, and then we can entertain other

12 comments. 

13 It's clear that the staff has an immediate

14 job of getting the responses to the comments for

15 the two rule-makings and getting the rule-making

16 out the door. I think you were shooting for an

17 April 1st to get that out your door and into the

18 system. It would seem to me that it would be in

19 the interest of the NIOSH staff if we did not

20 have a meeting in March that would detract from

21 their ability to get that immediate job done.

22 The pressing issues for this Board were the

23 comments on Part 81 and 82, which we hope to

24 complete today, so that I don't see a compelling

25 reason to meet in March, but there may be a
12 

NANCY LEE & ASSOCIATES

1 compelling reason not to meet in March.

2 Personal views? Let's get other comments.

3 Yes, James.

4 DR. MELIUS: What are you proposing, then,

5 as the next meeting, just roughly?

6 DR. ZIEMER: Then it would be an April time

7 frame. Did we collect the April -- you have the

8 April possibilities there?

9 MS. HOMER: Looks like in April the second

10 week. Dr. Anderson is only available on the

11 12th. Everybody else seems to be available all

12 week. The third week looks good. That would be

13 the 14th through the 20th.

14 DR. DEHART: I'm out that total week.

15 DR. ANDERSON: Yeah, I've got a wedding at

16 the end of the week -- not mine.

17 DR. ROESSLER: Cori, I must not have put it

18 on, but I'm out the week of -- I'm out April 9th

19 through 11th.

20 MS. HOMER: 9th through 11th? Okay.

21 DR. ROESSLER: And then in addition, on my

22 agenda, I changed an EPA advisory committee

meeting from March to April 23rd to 25th 23 . But you

24 can't get everybody, probably.

25 MS. HOMER: Well, how does the 22nd and 23rd
13 

NANCY LEE & ASSOCIATES

1 or 23rd and 24th sound?

2 DR. ANDERSON: That's the EIS conference at

3 CDC that week. For me, anyway, and I would

4 assume --

5 DR. ZIEMER: I'm out the 23rd. Actually

6 I'll be in Los Alamos on the 23rd. Maybe we

7 could meet out there.

8 MR. ESPINOSA: Sounds good to me.

9 DR. ZIEMER: Roy, did you say you were out

10 the week of the 15th?

11 DR. DEHART: Actually, I'm out -- well,

12 certainly from the 13th through the 18th.

13 Aerospace medical meeting.

14 DR. ZIEMER: Was the week of the 8th a

15 possibility?

DR. ROESSLER: Well, the 10th and 11th 16 ,

17 that’s the NCRP meeting.

18 DR. ZIEMER: That's right here, so if we met

19 the 8th and the 9th, why you could just go right

20 over there, right?

21 DR. ROESSLER: Sure.

22 DR. ANDERSON: Yeah, I have a conflict on --

23 I think, Jim, you're on the Rocky Flats --

24 DR. MELIUS: Yeah, we both –

25 DR. ZIEMER: Okay. Is the 11th and 12th of
14 

NANCY LEE & ASSOCIATES

1 April out, also?

2 UNIDENTIFIED: The 12th is okay, but not the

3 11th.

4 DR. ZIEMER: What about -- I'm out the 4th

and 5th, but what about the 1st through 3

rd 5 ? Any

6 problems there?

7 UNIDENTIFIED: For which month?

8 MR. ELLIOTT: That's too close.

9 DR. MELIUS: We've already committed -- all

10 of us have set aside those other two. To move it

11 a week is hardly worth it.

12 DR. ZIEMER: Oh, right, that doesn't help

13 much.

14 DR. ANDERSON: May 2 or 3?

15 MS. HOMER: First week of May looks open.

16 DR. ZIEMER: Any conflicts beginning April

17 29 through May 3rd? 

18 (No responses)

19 DR. ZIEMER: Hey, looks good, doesn't it?

20 DR. ANDERSON: I have a conflict Monday and

21 Tuesday, but --

22 DR. ZIEMER: That's the 29th and 30th.

23 DR. ANDERSON: Yeah. So 1, 2, or 3 is fine.

24 DR. ZIEMER: Anyone with a conflict May 1st

25 through 3rd?
15 

NANCY LEE & ASSOCIATES

1 (No response)

2 DR. ZIEMER: Shall we try for either 1st and

3 2nd, or 2nd and 3rd?

4 UNIDENTIFIED: I'm sorry?

5 DR. ZIEMER: 1st and 2nd, or 2nd and 3rd,

6 depending on availability of facilities and so

7 on? Does that sound --

8 MS. HOMER: That's good.

9 DR. ZIEMER: Okay, let's all pencil that in.

10 Block off 1st through 3rd until we get it

11 finalized. 

12 Any reason we shouldn't just meet here again

13 in D.C.?

14 (No response)

15 DR. ZIEMER: Sounds okay.

16 MS. HOMER: I'll check on the availability

17 of the hotels.

18 DR. ZIEMER: Cherry blossoms still out then,

19 or -- is that on your calendar? Too late.

20 Okay, we have tentative dates, then, blocked

21 off for that meeting. Now let me make sure, is

22 everybody agreeable that we should postpone till

23 then? Is there any that feel that there's

24 compelling reason to meet in March? I don't want

25 to preclude that. 
16 

NANCY LEE & ASSOCIATES

1 Yes, Roy, please.

2 DR. DEHART: I was just curious. There are

3 probably some topics that would not need

4 presentation by the NIOSH group, but where others

5 from outside could come in. We were hearing

6 yesterday about a number of dose critical issues

7 where when it was really -- the paper record was

8 really checked, it was found not to be adequate.

9 Could we hear those stories? That's the kind of

10 information that perhaps wouldn't take so much

11 time. But again, you see a lot of people sitting

12 around here that might have to be here in any

13 case, which would interfere with the staff, I

14 don't know.

15 DR. MELIUS: Yeah, I think along those lines

16 there's those topics. 

17 I think it would be useful to hear a

18 legislative history or background, particularly

19 with relationship to Special Exposure Cohorts.

20 But I think there's other sections that would be

21 helpful to hear from some of the Congressional

22 staff. There's David Michaels, there's a lot of

23 -- somebody can choose who, but sort of a panel

24 to present to us the legislative background.

25 There's a number of topics related to the
17 

NANCY LEE & ASSOCIATES

1 IREP model and so forth that we had talked about

2 at the first meeting, that I think it would be

3 useful to get a panel together to give us

4 background on some of the issues related to that.

5 So I don't think it necessarily has to

6 require the NIOSH staff to spend a lot of time

7 preparing for us, and that will somewhat depend

8 on where they are with the various regulations.

9 But I think getting some of that background

10 together with information would be good, and

11 would be a good use of a meeting so that down the

12 road we're prepared for -- as these issues come

13 up.

14 DR. ZIEMER: Let me ask both Roy and Jim,

15 are you suggesting that there's an urgency to do

16 that in March rather than, say, April? Certainly

17 that could be part of the April thing. I think

18 these folks are going to be pretty well tied up

19 through March anyway, so maybe having that topic

20 at the April meeting might still be appropriate

21 to have.

22 DR. MELIUS: Yes, that's what I was saying.

23 DR. DEHART: That would be fine with me. I

24 just would like to see some of that information

25 presented soon.
18 

NANCY LEE & ASSOCIATES

1 DR. ZIEMER: Henry had a comment.

2 DR. ANDERSON: Yeah, I would agree. I would

3 like to hear some of the other background, and

4 maybe have some of the peer reviewers from the

5 IREP come in and talk about their -- have more of

6 a dialogue with them at some point in time. 

7 And I think we also probably then need to do

8 some planning on how are we going to organize to

9 review -- I've just felt that we're very much in

10 a reactive mode, and to wait only until we have

11 something from NIOSH to present and review, we

12 may want to think about what are some of the more

13 proactive things that might be something that we

14 would carry on between several meetings. 

15 But April, in order to do that -- we could

16 probably put that -- I just don't want to get us

17 rushed again, because next will be coming the

18 NIOSH responses to the rule package, and changes

19 there that we may want to discuss as well. This

20 might be a catch-up meeting for us to look at

21 things that are good for us, but I don't feel

22 strongly about not postponing. I just don't want

23 to get caught down the line, that we spend all

24 our time reacting on a rapid basis rather than

25 kind of beginning to plan a process for the long
19 

NANCY LEE & ASSOCIATES

1 term.

2 DR. ZIEMER: Okay, good comment. Thank you.

3 Others? Wanda.

4 MS. MUNN: I agree fairly strongly with what

5 Henry had to say. 

6 I think it may take us a little time to get

7 our thoughts in order with respect to how we do

8 want to approach these evaluations we're going to

9 undertake. I think we ought to give the NIOSH

10 staff all the space they need in March to do

11 these ugly things they have to do to try to make

12 their deadline. By the same token, I'm

13 uncomfortable with putting our next meeting off

14 too far. I think it may be to our detriment to

15 have too much time between our meetings, even

16 though regularity, obviously with a group like

17 this, is going to be impossible. 

18 But there are several items -- I shouldn't

19 say several -- there's at least one item that I

20 would like to discuss with the group at some

21 juncture before we get too far down the road.

22 It's already behind us and nothing that can be

23 done about it, but there is some language in the

24 law that establishes this entire procedure, which

25 is -- there's not much of it, but what's there is
20 

NANCY LEE & ASSOCIATES

1 misleading, to say the least, and inaccurate is

2 the kindest word one can say about it. 

3 For a group like this to not comment on

4 that, I think would be inappropriate, and at some

5 juncture I'd like to discuss that with the Board.

6 But -- and would like that not to be long after

7 all of the disbursements have begun to take

8 place.

9 DR. ZIEMER: Thank you. Wanda, let me ask.

10 However, are you comfortable with the meeting

11 date that we're talking about, or are you urging

12 us to meet again in March? You said that you

13 wanted to give them space, so I took that to mean

14 you're okay with this proposed meeting date that

15 we talked about.

16 MS. MUNN: I think we should just throw up

17 our hands with respect to March.

18 DR. ZIEMER: Yes, okay.

19 MS. MUNN: It looks impossible to me.

20 DR. ZIEMER: Thank you.

21 MS. MUNN: And my preference would have been

22 April, but that also looks impossible at this

23 juncture.

24 DR. ZIEMER: Well, we're not too far out of

25 April, so --
21 

NANCY LEE & ASSOCIATES

1 MS. MUNN: This is true, so May is fine.

2 DR. ZIEMER: Thank you. 

3 Any other comments as --

4 DR. ANDERSON: Do we want to look at some

5 other dates? By the time we get to May, I think

6 we're then going to find that June is gone,

7 because everybody's going to fail. So if we're

8 going to plan for three or four meetings four to

9 six weeks apart, we may want to start to look at

10 some of those dates.

11 DR. ZIEMER: Cori, can we distribute the

12 calendars, or do you want to just have us tell

13 you what our bad dates are again through May,

14 June, and on beyond?

15 MS. HOMER: Yeah, you have May.

16 DR. ZIEMER: Okay. In the packet -- is it

17 in the packet? There is a tab in the packet

18 called 2002 year planner. So I think, Cori, if

19 this is what you want, have each person put their

20 name on that, and then X out your bad dates. Is

21 that how we want to do that?

22 MS. HOMER: Yes.

23 DR. MELIUS: That's how we did it last time.

24 MS. HOMER: We did it that way last time.

25 DR. ZIEMER: But how far did -- last time we
22 

NANCY LEE & ASSOCIATES

1 only had through May, so --

2 MS. HOMER: Some folks have given me June,

3 but --

4 DR. ROESSLER: But that changes.

5 UNIDENTIFIED: It changes.

6 MS. HOMER: Yes, it does.

7 DR. ZIEMER: Why don't you update that, and

8 let's -- how far can we go now? Can we take it

9 on through at least August, and get those dates?

10 And then turn those in yet today. Thank you.

11 Could we also then ask the staff, as you're

12 able to begin identifying who might some of these

13 presenters be -- again, I think there will be

14 time, but we do have to allow those people time

15 to schedule things, too. So having a little

16 advance notice will be important there. 

17 Jim.

18 DR. MELIUS: Could I make a suggestion that

19 maybe we set up a -- I don't know if it's a

20 subcommittee or group, just to work with the

21 Chair, a couple of people to help choose some of

22 the people, or we can work with the staff in

23 terms of coming up with some names and people

24 from the outside that we might want to come in

25 for those meetings? That might make it easier,
23 

NANCY LEE & ASSOCIATES

1 rather than have the staff calling around and --

2 DR. ZIEMER: Let me -- Jim, would this work

3 just as if you know of or have suggestions, just

4 to turn those over to Larry, and let them try to

5 put together something? Do you think you need --

6 do we need a subcommittee, or --

7 DR. MELIUS: That would be -- if they want,

8 prefer that way, that's fine, too.

9 MR. ELLIOTT: That would be great. Whatever

10 your suggestions are, if you can give them to me.

11 And certainly I've already talked with David

12 Michaels. I think he would be pleased to accept

13 an invitation to present on the legislative

14 background to you. Josh Silverman and I spoke

15 this morning, and I think DOE would welcome an

16 invitation to talk about records. But others,

17 I'm sure there are other people that you know of

18 you would like to hear from.

19 DR. MELIUS: Can I just -- maybe if we can

20 do that interactively, then, if you could then e21 mail out what you think will be the agenda and

22 who the speakers would be. Then if someone says,

23 well, I really think we ought to hear from

24 someone with this viewpoint or this experience

25 would be a good addition, or some point, then I
24 

NANCY LEE & ASSOCIATES

1 think at least we're not getting to the meeting

2 and saying, well, next meeting we should have

3 somebody else come in.

4 The other thing I would request maybe for

5 setting up this meeting, so we don't get to May

6 and be struggling with a July meeting, because by

7 that time our calendars will all have changed

8 also, is if Larry could work with the Chair. And

9 I think somebody’s just going to make a decision

10 at some point that not everyone can be there, and

11 maybe make it your -- we'll have someone to blame

12 besides Larry.

13 DR. ZIEMER: I was hoping that wouldn't

14 happen, but we'll do that. Sure, we'll do that.

15 DR. MELIUS: But also, again, if you'd let

16 us know. There are times we can move meetings if

17 we're not available, just -- the farther ahead we

18 can do this, I think the better, that's all.

19 DR. ZIEMER: Right, it's sort of the first

20 thing on the calendar is going to get the

21 priority in many cases, so right.

22 DR. MELIUS: Exactly.

23 DR. ZIEMER: Right. 

24 Okay, other comments? 

25 Thank you, that's very helpful.
25 

NANCY LEE & ASSOCIATES

1 (No response)

2 DR. ZIEMER: Let us now proceed to the

3 discussion and development of the dose

4 reconstruction rule comments. 

5 We did ask for each of you to give some

6 thought and maybe jot down some ideas. What I

7 thought we might do to begin is to prepare a kind

8 of inventory of the items that we want to

9 address, just to identify them. We sort of did

10 this at the end of the session yesterday. But

11 I've asked Cori to help us by preparing an

12 overhead; that is, she will prepare it as we make

13 the inventory. 

14 Is this agreeable, to try to identify the

15 items that we wish to comment on? And then we

16 can talk about actually developing the formal

17 comments after we see what it is that's before us

18 in terms of numbers of items and the subjects.

19 Is that agreeable, to try to get an inventory

20 here?

21 Now one of the reasons I'm suggesting we do

22 this is because I've started an inventory. I

23 actually have a list of eight items that I put

24 together, I think based on yesterday's comments.

25 And so what I thought I would do is identify
26 

NANCY LEE & ASSOCIATES

1 these, and then we can either delete or add to

2 them. But most of these -- and these aren't my

3 ideas. These are ones that I think I heard

4 yesterday from the Board.

5 For example, the first item would be to move

6 the paragraph Item J Section 2 (sic), and you can

7 say move Item J, Section 2, page 50981, to the

8 body of the rule. This is the one dealing with

9 the role of this Board. Actually, the whole

10 paragraph, which is not only the role of the

11 Board but the general idea of revising, perhaps

12 the whole thing should move. So maybe to

13 identify this, move Item J, sentence -- let's say

14 Item J of the background section to the body of

15 the rule. We can come back and talk about these,

16 but let me get the list up here.

17 MS. HOMER: Move Item J from background to

18 where?

19 DR. ZIEMER: To the body of the rule. I'm

20 not sure where that would go, actually, but --

21 DR. DEHART: It's page 50981.

22 DR. ZIEMER: Yeah, page 50981 is where that

23 is. That's where this section is.

24 The second item is Section 82.10, paragraph

25 (j), so 82.10(j), clarify the use of the term
27 

NANCY LEE & ASSOCIATES

1 “validated.”

2 DR. ROESSLER: What page is that on?

3 MS. NEWSOM: 50988.

4 DR. ZIEMER: Third item, clarify the steps

5 and time line for -- oh, I'm sorry, I should have

6 given you the section first. That's all right,

7 put it in the next -- that'll be Section

8 82.10(m), (n), (o). Clarify the steps and time

9 line for claimant's action on form OCAS-1,

10 claimant's actions on form OCAS-1.

11 Section 82.14(f)(1), clarify the use -- this

12 is one I just picked up; we didn't talk about

13 this. But the title of this uses the word “may,”

14 and the words used -- use the word “will.” There

15 seems to be a discrepancy, so I'm suggesting a

16 clarification on the use of “may” and “will.”

17 It's -- let's get the page -- page 50989. 

18 If you look at the title of Section 82 --

19 I'm sorry, I have the wrong one. It's 82.13.

20 I'm sorry, I gave you the wrong one, 82.13. I

21 gave you the wrong one there. Just cross out the

22 (f)(1); it's just 82.13. Look at the title, and

23 then the sentence right after the title. It

24 appears to me to be a conflict. We might decide

25 it isn't, but put it down here for the moment.
28 

NANCY LEE & ASSOCIATES

1 82.14(f)(1), and this is one that was not

2 discussed yesterday. But I noticed last evening,

3 and maybe I'll ask the question, and probably

4 should direct it to Jim Neton. On the medical

5 screening with X-rays, are there other medical

6 screening procedures that use radiation that may

7 not be X-rays that should be included? Were

8 there any nuclear medicine procedures or other

9 imaging modalities, or is it only medical X-rays?

10 DR. NETON: There are no other modalities

11 that I'm aware of as far as nuclear medicine,

12 screens or something like that, that were

13 required, occupationally required, in what I

14 would consider like a surveillance-type program.

15 DR. ZIEMER: Therefore only -- so, then, as

16 far as I'm concerned this can drop out. I was

17 just raising the question as to whether that was

18 restrictive in a way that it was not intended, so

19 I think it can drop out.

20 82.18, this is another one that we did not

21 discuss, but I picked up last night. It requires

22 the use of NCRP (sic) models. There's nothing

23 said about the fact that they should be current

24 models. Is there a need for clarification? So

25 right now I've just said to clarify that.
29 

NANCY LEE & ASSOCIATES

1 DR. NETON: Do you mean ICRP models?

2 DR. ZIEMER: ICRP; did I say NC? I meant

3 ICRP models. The statement is that ICRP models

4 will be used. Do we want to say current ICRP

5 models or something like that? So that was my

6 point in raising that.

7 Next item is 82.28(b), clarify the

8 restriction concerning the availability of the

9 names of claimants to researchers. Clarify the

10 restriction concerning the availability of the

11 names of claimants to researchers.

12 Then the last item on my list is answer the

13 three questions.

14 Now I'm aware that there is at least one and

15 possibly two that I simply couldn't remember or

16 hadn't made a note on, and so -- but some of you

17 will remember your own items from yesterday to

18 add to this list. So let me now open it up.

19 I think, Jim, you may have had one that I

20 simply couldn't remember.

21 DR. MELIUS: No, I've forgotten it also.

22 DR. ZIEMER: Good, I feel good about that,

23 then. If you don't remember it --

24 DR. MELIUS: I don't.

25 DR. ZIEMER: Well, if it comes to you --
30 

NANCY LEE & ASSOCIATES

1 does anyone remember the great idea Jim had

2 yesterday?

3 MS. MURRAY: I'll check back in my notes

4 from yesterday and see, because I underline

5 things that look like --

6 DR. ZIEMER: Good, okay. Are there some

7 others?

8 (No response)

9 DR. ZIEMER: Did you have one that I missed

10 here? Okay, please, Bob.

11 MR. PRESLEY: Bob Presley. Yesterday we

12 came out on 82.16 where it says evaluate and

13 validate, and I had marked word “validate” on

14 there. We had some discussion on that. I don't

15 think that's up there.

16 DR. ZIEMER: Item two, Bob.

17 MR. PRESLEY: I'm sorry.

18 DR. ZIEMER: I think that was the one that

19 you had raised, clarify the use of the term

20 “validated” in Section 82 -- is that the right

21 section? Is there another --

22 MR. PRESLEY: 82.16 is the one I marked it

23 on.

24 DR. ZIEMER: Oh, okay. So is there another

25 one, then?
31 

NANCY LEE & ASSOCIATES

1 DR. ANDERSON: Yes. I think you’ve caught

2 it.

3 DR. ZIEMER: Yes, that is 82.16.

4 DR. ANDERSON: And there was also on --

5 DR. ZIEMER: Actually, it looks like it's

6 82.16. The 82.16 is simply in the sentence.

7 It's not that --

8 MR. PRESLEY: That's right, I'm sorry.

9 DR. ZIEMER: It actually is 82.10, but the

10 sentence just ahead of that ends with the words

11 82.16, and it makes it look like that's the

12 reference.

13 So what I'm asking now, we have this list

14 before us. Are there any things on the list that

15 you think we should not comment on? Are there

16 some things that aren't on the list that we

17 should comment on?

18 MR. PRESLEY: Bob Presley again. I had

19 marked 82.12, that title, will it be possible to

20 conduct dose reconstruction for all claimants --

21 for all claims? We had a discussion on that.

22 DR. MELIUS: Can I follow up on that? I'm

23 not sure if this fits as a comment directly on

24 that, or is an answer to one of the three

25 questions. 
32 

NANCY LEE & ASSOCIATES

1 But I believe we should comment on the

2 limits of -- I don't think that the regulations

3 in what we've heard so far have clarified, at

4 least for my mind, when NIOSH will not be able to

5 do an accurate dose reconstruction. 

6 Now some of this backs into the whole issue

7 of Special Exposure Cohorts, because one of our

8 tasks in the legislation is to advise the

9 Secretary when they're not able to do an accurate

10 dose reconstruction, if there are groups of

11 people for whom they cannot do it. And so it's

12 hard to -- it may be that the Special Exposure

13 Cohort regulations, if they come out there, would

14 specify this. 

15 But I think we ought to comment that this is

16 something that the Board needs to continue to

17 monitor and work with NIOSH on. I'm just very

18 uncomfortable with the implication that we're

19 going to reconstruct every dose. Well, you can

20 do that, but how accurate will it be, and so

21 forth. And I think we should say that that's

22 something the Board needs to continue to follow

23 and work with NIOSH on.

24 DR. ZIEMER: Jim, let me ask this. Are you

25 suggesting that this might be a sort of general
33 

NANCY LEE & ASSOCIATES

1 comment as opposed to some change in the rule2 making? In other words, it seems conceivable

3 that dealing with that in detail might be in the

4 guidance document as opposed to the rule, but

5 that perhaps you would wish to have the Board

6 comment in a general sense as opposed to adding

7 something to the rule, some detail that spells

8 out how they're going to make this decision, or -

9 -

10 DR. MELIUS: I think there are options.

11 Whether -- I can't come up with wording that

12 could be put in the regulation right now. I

13 think that's difficult, particularly until

14 they've done the Special Exposure Cohort. You

15 can define it by -- from the other side, from the

16 Special Exposure Cohort side, easier than you can

17 say when can you not do it in terms of a

18 regulation.

19 I think it's more likely through the

20 manuals, the procedures, and so forth that we

21 would be able to advise them and get

22 clarification on that. I spent some time last

23 night going through those sections of the manuals

24 that we were given, handbooks, and trying to see

25 if there was adequate information in there, and I
34 

NANCY LEE & ASSOCIATES

1 was not. I don't believe there is at this point

2 in time. It is something that is very hard to

3 define. How do you define when you can't do

4 something is difficult.

5 But I think it's such a critical point that

6 we need to comment on it in a general way,

7 leaving a number of options; that this is

8 something that would be clarified either in

9 regulation, in procedure, or as we work with

10 NIOSH on reviewing the dose reconstructions that

11 they do. And I would hope that that would be one

12 focus of our reviews.

13 DR. ZIEMER: It appears to me, then, that

14 that concept might be included as part of our

15 comments to question one –

16 DR. MELIUS: (Nods head)

17 DR. ZIEMER: -- which is does the interim

18 rule make appropriate use of current science for

19 conducting dose reconstruction, and in that

20 context to raise this issue. Would that be

21 agreeable?

22 DR. MELIUS: And I also think it pertains --

23 I think it’s question two that talks about the

24 efficiency of the process --

25 DR. ZIEMER: Yes.
35 

NANCY LEE & ASSOCIATES

1 DR. MELIUS: -- because there's also how

2 much effort do you put into doing this. The more

3 effort, the greater accuracy or whatever. But it

4 may be out of proportion to what you gain.

5 DR. ZIEMER: So let me ask you to take it

6 upon yourself to make sure, as we word both

7 question one and two, that that idea gets

8 incorporated in an appropriate way, then. Thank

9 you.

10 Other items?

11 MS. MUNN: No, I just wanted to comment on

12 what Jim had just said. 

13 I found last night when I was trying to put

14 together my comments with respect to the three

15 items we felt we needed to comment on that

16 precisely because of the kinds of things you

17 mentioned, Jim, I found these things overlapping

18 and not as easy to quantify in terms of response

19 to number one, response to number two, and

20 response to number three. So I --

21 DR. ZIEMER: They probably aren't mutually

22 exclusive, yes.

23 MS. MUNN: So I wound up with language that

24 did accommodate several of the things that you

25 were speaking of; whether in the way you want, I
36 

NANCY LEE & ASSOCIATES

1 don't know. But I think they probably fall in

2 the general --

3 DR. ZIEMER: We’ll hopefully make use of

4 that in just a little bit, then. Okay.

5 Again, let me ask if there are other items,

6 then, that we need to identify here, separate

7 items?

8 (No response)

9 DR. ZIEMER: Is there anything on the list

10 that you would wish just to delete or not

11 address?

12 (No response)

13 DR. ZIEMER: Some of these may turn out to

14 be as simple as clarify the use of the word

15 “may.”

16 MS. MURRAY: Yeah, that one -- let’s me see

17 -- number four, is that about the closing after

18 60 days? That was one you had brought up

19 yesterday.

20 DR. ZIEMER: No, the closing after 60 days

21 has to do with the clarification of the steps and

22 time line, item three. It's the time line thing.

23 MS. MURRAY: Okay. 

24 DR. ZIEMER: That was the 60-day issue.

25 MS. MURRAY: I’m still looking.
37 

NANCY LEE & ASSOCIATES

1 DR. ZIEMER: If something else turns up, we

2 can always come back. I'm not saying this is

3 restrictive at this point, but it sort of gives

4 us a road map of where we have to go today to

5 sort of finish our task.

6 Do I sense that there's general agreement

7 that this scopes what we have to do?

8 (No response)

9 DR. ZIEMER: Now as we look at this list, a

10 number of these items are very straightforward

11 and simply require a sentence or two. To move

12 Item J, for example, and we can get wording

13 that's similar to what we said last time. We

14 don't need to spend a lot of time here, but we'll

15 have one of us work up that wording.

16 Clarify the use of the term “validated,”

17 clarify steps and time line for claimants,

18 clarify use of the word “may.” I guess almost

19 everything, one through six, is probably fairly

20 straightforward, a single sentence or two,

21 probably, which means we would focus most of our

22 attention on the three questions.

23 It occurs to me, though, there was an

24 additional question -- maybe Dr. Roessler doesn't

25 wish to raise it, but Gen, didn't you have -- you
38 

NANCY LEE & ASSOCIATES

1 were going to talk -- or you talked to me about

2 the use of the term “precision and accuracy.” Is

3 that something you don't wish to raise, or do

4 wish to raise?

5 DR. ROESSLER: I think I have to now.

6 (Laughter)

7 DR. ROESSLER: I will raise it, since you

8 brought it up. It's not --

9 DR. ZIEMER: Well, I thought maybe you were

10 just being shy.

11 DR. ROESSLER: It's not in the rule -- well,

12 it's not in the part we were looking at. It's on

13 page 50978, in the second question that we are

14 going to deal with. And it's the use of the –

15 DR. ZIEMER: Part of the question itself, is

16 it not?

17 DR. ROESSLER: It's part of the question

18 itself, and it's the word “precision.” And I

19 guess before I talked this morning to a number of

20 people, I would have thought that based on

21 Larry's comments that they are going to try and

22 produce the most accurate results possible; that

23 should be accuracy. But now I'm not sure what

24 the word should be. I think perhaps as we deal

25 with that question we should look at the wording
39 

NANCY LEE & ASSOCIATES

1 on it.

2 DR. ZIEMER: Okay, thank you. 

3 Wanda.

4 MS. MUNN: That was one of the things I

5 addressed in my generalized wording, and what I

6 said was the Board recognizes that if efficient

7 and expeditious consideration of claims is to be

8 made, absolute precision is not possible. And

9 that's, I think, a response to the question they

10 wanted answered, and incorporates the recognition

11 that the further down the precise road you go,

12 the more time and money are being incorporated in

13 the process.

14 DR. ZIEMER: So perhaps the issue will

15 emerge in an appropriate way as we word the

16 answer to the question. Okay.

17 Now let me ask how many of you, on your own,

18 prepared sets of wording such as Wanda has done?

19 Wanda, you have some words. Robert, you

20 have some. Gen has some. Three sets of wording,

21 okay.

22 Wanda, did you prepare words for all three

23 questions?

24 MS. MUNN: Yes, I did, but I did not number

25 them one, two, three. They're all sort of --
40 

NANCY LEE & ASSOCIATES

1 DR. ZIEMER: 1A, 1B, 1C, I guess.

2 MS. MUNN: Well, as Jim pointed out, some of

3 them --

4 DR. ZIEMER: Okay. But you've tried to

5 address them all?

6 MS. MUNN: Yes.

7 DR. ZIEMER: Robert, how about you?

8 MR. PRESLEY: Yes.

9 DR. ZIEMER: Gen?

10 DR. ROESSLER: I mostly have two comments on

11 two, the second question.

12 DR. ZIEMER: And -- the first and the

13 second, or --

14 DR. ROESSLER: No, just --

15 DR. ZIEMER: Oh, just comments on number

16 two, okay. I thought you meant –

17 DR. ROESSLER: I couldn't think of really

18 anything to do with the first, other than using

19 part of what we did last time.

20 DR. ZIEMER: Okay. Now let me ask the group

21 if you would like to work on these three

22 questions as a committee of the whole, or we can

23 have each individual get their words up for us as

24 straw men to look at, or do you prefer to break

25 into smaller groups?
41 

NANCY LEE & ASSOCIATES

1 DR. MELIUS: I think the committee as a

2 whole would be better.

3 DR. ZIEMER: Okay, we can do that. 

4 Now I'm trying to see what the most

5 expeditious way to do this would be. I have a –

6 Okay, go ahead. Henry's got a suggestion.

7 DR. ANDERSON: I was going to say, since I

8 raised the availability of names, do we want to

9 just leave it kind of generic like this? Or do

10 you want us to propose specific language, because

11 there are some --

12 DR. ZIEMER: No, I want some specific

13 language on each of these, and --

14 DR. ANDERSON: Because I have some specific

15 correction or additional language that would

16 clarify six that I –

17 DR. ZIEMER: Right, If we have that, then

18 we'll do that. 

19 Let me suggest the following, and we'll take

20 a -- we're going to take a break. But I'll ask

21 each of those who have prepared something, if we

22 can get it -- is it readable if we photocopied it

23 onto a transparency?

24 MS. MUNN: Just barely.

25 DR. ZIEMER: Just barely. Well, the
42 

NANCY LEE & ASSOCIATES

1 alternative would be to take a transparency

2 during the break and have you write on the

3 transparency.

4 MS. MUNN: Oh, please, do take this and make

5 a transparency of it.

6 DR. ZIEMER: Let me ask Cori -- is Cori

7 still here? Well, we'll take a break and find

8 out during the break, because maybe what we can

9 do is take that, do a blow-up of it and then a

10 transparency, and get it up before us so we can

11 see the words. And if we can do that on the

12 others, either hand-write them onto a

13 transparency, or we'll photocopy them. And then

14 after the break then we can work on the words. 

15 Is that agreeable? Okay, let's take a

16 15-minute break.

17 (Whereupon, a recess was taken from

18 9:53 to 10:25 a.m.)

19 - - -

20 DR. ZIEMER: I'd like to call us back to

21 order. 

22 We're going to work here a little bit in

23 real time. Cori has already typed in some

24 sentences which will be straw men for the general

25 big three questions. We also have some words for
43 

NANCY LEE & ASSOCIATES

1 the sort of brief sentence ones that we talked

2 about. And I think right now these are being

3 numbered in the order that we had them on the

4 overhead, the first one being the moving of

5 Section J from the background or the preamble of

6 the rule-making, moving that into the body of the

7 rule-making. And those words are being put up

8 there even as we speak.

9 I might ask you to open your books to 50981,

10 Section J, because as I proposed the wording on

11 this it would basically be to move the whole

12 section, which includes the sentence about the

13 public petitioning for changes in the rule14 making, as well as the Board's review of proposed

15 changes in the rule-making. 

16 The words here now would say that the Board

17 recommends that Section J, concerning changes to

18 scientific elements underlying the dose

19 reconstruction process, be moved to the main body

20 of the rule, and then it should say so as -- the

21 main body of the rule so as to formalize the

22 updating process -- you need to insert a “so”

23 after the word “rule” at the beginning of the

24 line that you're on there, Cori – so as to

25 formalize the updating process.
44 

NANCY LEE & ASSOCIATES

1 It is actually Section K, how will NIOSH

2 make changes in the scientific elements

3 underlying. It should be Section K.

4 MS. HOMER: Instead of J?

5 DR. ZIEMER: Instead of J, be moved to the

6 main body of the rule so as to formalize the

7 updating process. And I guess all we really need

8 to say there is the updating process, including

9 the role of the Board, and that'll parallel, or

10 the role of the Advisory Board. We don't have to

11 go through all the details. 

12 Should we say Advisory Board?

13 UNIDENTIFIED: Yes.

14 DR. ZIEMER: Okay. 

15 Now, Cori, why don't you go ahead and start

16 working on that second brief one that you have

17 while we look at --

18 MS. HOMER: Marie's working on it.

19 DR. ZIEMER: Oh, okay. Okay. 

20 Let's look at those words. We can just take

21 these -- some of these I think will be fairly

22 simple. 

23 Is there any comment on that first one

24 there, just that first sentence? Just the first

25 sentence up there. That's the first
45 

NANCY LEE & ASSOCIATES

1 recommendation. Nothing to do with the three

2 questions. That's just the moving of that

3 section on updating from the preamble to the body

4 of the rule. It basically codifies the role of

5 the Board in changes.

6 (No response)

7 DR. ZIEMER: Can I have a motion that we

8 adopt this as a recommendation?

9 DR. DEHART: So moved.

10 DR. ZIEMER: Second? 

11 UNIDENTIFIED: (Inaudible)

12 DR. ZIEMER: Formal discussion on this?

13 (No response)

14 DR. ZIEMER: Word changes, pro or con?

15 (No response)

16 DR. ZIEMER: All in favor, say aye.

17 (Affirmative responses)

18 DR. ZIEMER: Opposed?

19 (No response)

20 DR. ZIEMER: Now I might add that -- I'm not

21 proposing that we're going to adopt all these as

22 we go. I think some of the simple ones we'll

23 just do, but I want to save particularly our

24 actions on the three questions and so on till

25 after the public comment period today, in
46 

NANCY LEE & ASSOCIATES

1 fairness to hear other views. Some of these are

2 more sort of minor things in how the rule is

3 written right now.

4 We had the item on clarifying the use of the

5 term “validated.” And Roy, did you -- who

6 rewrote that? Did somebody rewrite that?

7 DR. DEHART: That was number three.

8 DR. ZIEMER: That was number three?

9 MS. MURRAY: Just about done.

10 DR. ZIEMER: Just about done? 

11 What was number two? 

12 MS. HOMER: (inaudible)

13 DR. ZIEMER: I meant number two from our

14 early list. I had on my list that number two was

15 the use of the word “validated.”

16 MR. PRESLEY: That's right, 82.10(j).

17 DR. ZIEMER: Yes.

18 DR. DEHART: Do you have the overhead?

19 DR. ZIEMER: Yes.

20 MS. HOMER: Number two, Section 82.10,

21 paragraph (j), clarify the use of the term

22 “validated” on page 50988.

23 DR. ANDERSON: It seems to that what we

24 might want to do is ask -- that might be a good

25 one for a definition, that if they were to define
47 

NANCY LEE & ASSOCIATES

1 “validated” up front in their list of

2 definitions, then that would tell us what they

3 mean.

4 DR. ZIEMER: So possibly something as

5 follows: The Advisory Board requests that the

6 term “validated” be either defined or clarified.

7 DR. ANDERSON: Yeah.

8 DR. ZIEMER: Let's say “validated” as used

9 in Section 82.10(j).

10 Now let me ask if that captures the idea,

11 because this may be all we need to do on that.

12 Does someone wish to move adoption of that?

13 MR. PRESLEY: So moved.

14 DR. ZIEMER: Second?

15 MS. MUNN: Second.

16 DR. ZIEMER: Any discussion?

17 (No response)

18 DR. ZIEMER: All in favor, say aye.

19 (Affirmative responses)

20 DR. ZIEMER: Any opposed say no.

21 (No response)

22 DR. ZIEMER: Carried. 

23 The third one had to do with the time line.

24 Is that correct?

25 MS. HOMER: Clarify steps and time line for
48 

NANCY LEE & ASSOCIATES

1 claimants.

2 DR. ZIEMER: Right. And Henry, did you have

3 the words on that?

4 DR. ANDERSON: No.

5 DR. ZIEMER: Who did the time line words?

6 Did anybody?

7 (No response)

8 DR. ZIEMER: Okay, we'll come back to that

9 one, then.

10 What we had as number four was the use of

11 the word “may” versus “will.” If you'll turn to

12 Section 82.13, and I'd like to ask Ted -- is Ted

13 here? Yes, Ted, you explained that to me, I

14 think, in a satisfactory way. We may be able to

15 drop it. I'd like you to clarify that to the

16 Advisory Board.

17 MR. KATZ: Sure, thanks. 

18 So the title says, what sources of

19 information may be used for dose reconstruction?

20 And we want that to be inclusive of

21 possibilities, but not binding NIOSH to using all

22 sources under that title in each instance.

23 And then the following sentence, which Dr.

24 Ziemer noted sounds contradictory, it says NIOSH

25 will use the following sources of information for
49 

NANCY LEE & ASSOCIATES

1 dose reconstructions, but it has the caveat “as

2 necessary,” so it in fact isn't binding NIOSH to

3 use all of those sources for each instance. 

4 So they're actually, I think, they're

5 consistent and appropriately organized.

6 DR. ZIEMER: So I was comfortable with that

7 explanation, and felt we probably could drop

8 this. But I wanted, since we had it on the

9 floor, to see if there are those who wish to keep

10 it, or are you satisfied with what you just heard

11 as the explanation?

12 (No response)

13 DR. ZIEMER: Are there any that object to

14 just dropping that one?

15 (No response)

16 DR. ZIEMER: Without objection, it will drop

17 from our inventory of comments. 

18 Thank you, Ted.

19 We'll allow for those editorial corrections.

20 The intent was clear. Let's see. 

21 Pardon me?

22 MR. PRESLEY: Bob Presley. We said we were

23 going to drop five. Is that correct?

24 DR. ZIEMER: I think the number that I had

25 it here on my list was four. Was it four? Was
50 

NANCY LEE & ASSOCIATES

1 four on our inventory list, the use of “may” and

2 “will.” Okay. We're just dropping that one.

3 I have number five as being the reference to

4 the ICRP models. Might I suggest that on that

5 one, rather than us trying to specify what ICRP

6 models are to be used -- right now, as it appears

7 in here, there would be no restrictions on what

8 ICRP models are used, including the ICRP 2. And

9 I think that's not the intent. The intent is to

10 use current models, but it doesn't say that,

11 either.

12 So perhaps the best thing that we could do

13 right now is to ask NIOSH to clarify in some way

14 the intent and meaning of the phrase “ICRP

15 models,” so as to -- without us trying to say

16 what those models are. I know that the intent is

17 to use current models, but current models may

18 change. And how rapidly does NIOSH need to

19 change when a new model comes out is also an

20 issue. 

21 I don't think we can solve that today, but

22 perhaps the way to address this is simply to ask

23 NIOSH to clarify their intent on the phrase “use

24 ICRP models.”

25 DR. ANDERSON: Could we put a modifier in
51 

NANCY LEE & ASSOCIATES

1 front and say most appropriate, which would --

2 DR. ZIEMER: Well, perhaps without us trying

3 to do the wording for them, simply ask the staff

4 to clarify that. 

5 Would that -- let me ask either Larry or

6 Jim, is this something that you could clarify the

7 wording? We would simply ask that that be

8 clarified in the final document.

9 DR. NETON: Yes, I think we could do that.

10 DR. ZIEMER: So that the recommendation --

11 let's see where we are here. Okay, we'll just

12 pause a minute, because they're inputting some

13 other words for a later comment.

14 DR. MELIUS: I wrote up number three and

15 gave it to them, so --

16 DR. ZIEMER: Okay, thank you. Number three

17 on the inventory list, yes.

18 DR. ZIEMER: Okay. Henry has suggested that

19 the words that just show up there under number

20 one be added to our original number one that we

21 adopted on the issue of moving Section K into the

22 body. Is that correct, Henry? This is simply

23 some words of amplification on the

24 recommendation.

25 (Reading) The rule does an admirable job of
52 

NANCY LEE & ASSOCIATES

1 providing an objective process for conducting

2 dose reconstruction. However, the assessment of

3 the adequacy of the exposure information will

4 involve professional judgment; thus some

5 subjectivity. The Board plays an important role

6 through its review of such decisions on dose

7 reconstructions, and that role needs to be

8 included in the rule.

9 DR. ANDERSON: I just thought we needed to

10 have a strong justification. Otherwise it sounds

11 very self-serving.

12 DR. ZIEMER: So Henry, you are making this

13 as a motion to add this to what we adopted for

14 the number one comment?

15 DR. ANDERSON: Yes.

16 DR. ZIEMER: Is there a second?

17 DR. ROESSLER: Second.

18 DR. ZIEMER: Any discussion?

19 (No response)

20 DR. ZIEMER: All in favor of this addition

21 to number one, say aye.

22 (Affirmative responses)

23 DR. ZIEMER: Any opposed, say no.

24 (No response)

25 DR. ZIEMER: Thank you. 
53 

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1 Now the one that's going up there now is

2 number three, I believe, the time line issue. 

3 Is this the one, Jim, that you prepared?

4 DR. MELIUS: Yes.

5 DR. ZIEMER: So what's being typed there

6 would be preceded by a pound sign three from our

7 inventory list.

8 (Reading) The Board recommends that NIOSH

9 clarify 82(m), (n), (o) in regards to the time

10 line for the claimants or representative of the

11 claimants to provide information to NIOSH as to -

12 -

13 DR. MELIUS: And to sign or submit.

14 DR. ZIEMER: And to sign or -- yeah, rather

15 than as. And to sign or submit form OCAS-1.

16 So while that's being typed before you, turn

17 to page 50988, right-hand column, and there are

18 the Sections (m), (n) and (o).

19 So the words that Jim has proposed here now:

20 (Reading) The Board recommends that NIOSH

21 clarify 82.10(m), (n), (o) in regards to the time

22 line for the claimants or representative of the

23 claimants -- should that be representatives?

24 UNIDENTIFIED: Claimants or their

25 representatives --
54 

NANCY LEE & ASSOCIATES

1 DR. ZIEMER: -- of the claimants -- that

2 could be editorial -- to provide information to

3 NIOSH and to sign or submit form OCAS-1. NIOSH

4 should ensure that the claimants or

5 representatives of the claimants have adequate

6 time to obtain and submit additional information

7 to NIOSH.

8 That's the proposed wording. Was that a

9 motion, Jim, to –

10 DR. MELIUS: Yes.

11 DR. ZIEMER: -- to include that? 

12 Is there a second?

13 MR. ESPINOSA: Second.

14 DR. ZIEMER: And seconded. 

15 Let me ask -- you haven't said anything

16 other than clarify. Is there an issue on the 60-

17 day, or do you think this will -- the

18 clarification that you're asking for will address

19 the 60-day issue?

20 DR. MELIUS: (inaudible) the 60 days.

21 Remember, the 60 days is (inaudible) how you

22 interpret –

23 MS. NEWSOM: Would you use your mike,

24 please?

25 DR. MELIUS: Sorry. It's as much how you
55 

NANCY LEE & ASSOCIATES

1 interpret (m), (n), and (o), and Ted and I

2 disagree on some of those paragraphs, but I think

3 it's just a matter of clarification.

4 DR. ZIEMER: So this would at least point

5 out that there's some degree of ambiguity there

6 that needs to be looked at.

7 Further discussion?

8 (No response)

9 DR. ZIEMER: Are you ready to act on motion

10 to adopt this recommendation? 

11 Yes, Wanda.

12 MS. MUNN: One minor comment. When we were

13 talking about it originally, we said we wanted

14 clarification of the steps and time line. Do we

15 want to include --

16 DR. ZIEMER: Yes, I have that same wording

17 in my notes. 

18 Jim and the seconder, do you object to

19 adding the word “steps?”

20 DR. MELIUS: No.

21 DR. ZIEMER: The steps and time line in line

22 one?

23 DR. MELIUS: I probably said it yesterday

24 and forgot, but --

25 DR. ZIEMER: That's the one you forgot, yes.
56 

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1 Steps and time line. And an editorial change,

2 let's say again the Advisory Board at the

3 beginning of the sentence.

4 Without objection, this is the motion, then.

5 DR. MELIUS: Could I -- if we’re

6 editorializing, actually the wording, I think,

7 used in the regulation is “authorized

8 representative of the claimant,” is the --

9 DR. ZIEMER: So noted. A friendly editorial

10 amendment, without objection, will be included.

11 Are we prepared now to act on this

12 recommendation?

13 All those in favor will say aye.

14 (Affirmative responses)

15 DR. ZIEMER: All opposed.

16 (No response)

17 DR. ZIEMER: Eyes above the nose, as they

18 say. That didn't work, did it?

19 MR. ELLIOTT: I laughed.

20 DR. ZIEMER: I was just seeing if

21 everybody's awake.

22 DR. MELIUS: And by the next meeting, your

23 staff better start laughing when you laugh,

24 right?

25 (Laughter)
57 

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1 DR. MELIUS: Speak to them, Larry.

2 MR. ELLIOTT: Point well taken.

3 DR. ANDERSON: Cori, did you get my number

4 six?

5 MS. HOMER: That's a good question.

6 MS. MURRAY: Uh-oh, is that this one

7 (indicating)?

8 (Laughter)

9 DR. ZIEMER: We have punts on one, two,

10 three. Number four was dropped. Number five was

11 the ICRP model one. Where is number five? 

12 MS. HOMER: (inaudible)

13 DR. ZIEMER: Okay, thank you. We'll pause

14 for a moment.

15 Okay, we're back to number five on the

16 inventory list, which was Section 82.18. In

17 referring to ICRP models, the Advisory Board --

18 I'll give you some words here -- In referring to

19 ICRP models in Section 82.18 -- start the

20 sentence over.

21 In referring to ICRP models in Section 82.18

22 -- actually, I already don't like this sentence

23 because I know what's going to happen. This is

24 going to end up as a dangling participle.

25 (Laughter)
58 

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1 DR. ZIEMER: And I want to advise everyone

2 that dangling participles are one thing that I

3 hate. I jump on my graduate students for them

4 all the time, and I can assure you that almost

5 any sentence beginning with I-N-G, including the

6 documents we reviewed yesterday, are full of

7 dangling participles, which someone needs to deal

8 with. So this sentence is going to be changed

9 before I even get it out. We're going to go back

10 to the Advisory Board -- we're going to get rid

11 of the dangling participle before it dangles.

12 MS. MURRAY: You can cut and paste later,

13 Cori.

14 DR. ZIEMER: Sorry.

15 The Advisory Board recommends that Section

16 82.18 concerning the use of ICRP models be

17 clarified so as to clearly indicate the models

18 that NIOSH intends to use.

19 Now let me ask somebody to move this

20 formally, and we'll get it on the floor here.

21 DR. ROESSLER: So moved.

22 DR. ZIEMER: Seconded?

23 MR. PRESLEY: (inaudible)

24 DR. ZIEMER: And seconded. 

25 The intent here is -- let me editorialize --
59 

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1 the intent here is not to ask them to list the

2 models in the document, but rather to indicate

3 how they decide what models to use. And I think

4 the intent is to use current models, but if we

5 ask them to put the word “current” in, then that

6 locks them into changing every time, immediately

7 when a new model comes out. And there has to be

8 some process by which the use of even new models

9 as they come out is handled. 

10 So perhaps we simply ask them to clarify,

11 and I think Jim and Larry have indicated that the

12 might come up with some appropriate words to make

13 sure that everybody understands it's the current

14 models within reason, so to speak. And does this

15 wording cover what we want to say here? 

16 And I think Wanda, do you have you hand up?

17 MS. MUNN: Yes, I do. In the second line,

18 could we -- don't type anything yet, Cori --

19 could we say indicate which models NIOSH intends

20 to use and the rationale for that choice?

21 DR. ZIEMER: I like that. I'll take that as

22 a friendly amendment if the mover and seconder

23 will assume that to be a friendly amendment.

24 MS. HOMER: To indicate which?

25 MS. MUNN: Which, take out “the,” and you
60 

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1 can take out “that.” Which models NIOSH intends

2 to use, comma --

3 DR. ZIEMER: Yes?

4 DR. ROESSLER: I thought of suggesting that,

5 too, but then to me “which” is very specific. To

6 me it would mean that they'd have to tell us. 

7 MR. PRESLEY: That’s what I –

8 DR. ROESSLER: I think it was better to

9 leave it -- I know what Wanda's saying, but I'm

10 afraid the “which” can be interpreted to mean

11 that they have to tell us the numbers or the

12 exact models.

13 DR. ZIEMER: That's not the intent here

14 either, is it, Wanda?

15 MS. MUNN: No, it isn't.

16 DR. ZIEMER: So that friendly amendment

17 turned out not to be so friendly, then.

18 MS. MUNN: That's true. It just screwed up

19 the whole thing.

20 DR. ZIEMER: It's rapidly turning to an

21 adversarial amendment.

22 DR. ROESSLER: What words did --

23 MS. MUNN: We don't want that.

24 DR. ROESSLER: What words did you use when

25 you had the dangling participle? I think there
61 

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1 were some other words in that section that might

2 have worked better.

3 DR. ZIEMER: Well, I don't want to return to

4 that.

5 DR. ROESSLER: No, I'm not saying to use the

6 I-N-G word, but on your paper there you had

7 something written after that that might work.

8 DR. ZIEMER: Well, I originally on my notes

9 had that we want them to specify that the most

10 current models are to be used, but I don't think

11 we want to specify here the exact wording of

12 this. I think the intent here would be to ask

13 them to word it in such a way that it's clear

14 that they are using current models, and have a

15 framework for incorporating new models as they

16 come into play.

17 MS. MURRAY: Could you just say current

18 models?

19 DR. DEHART: Aren't the people who are going

20 to answer that here, hearing our comments?

21 MR. ELLIOTT: This is sufficient.

22 DR. ZIEMER: Yeah, if this is sufficient, it

23 was simply to ask them to clarify. And part of

24 their clarification may be we're not going to

25 tell you the model numbers, but we're going to
62 

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1 tell you more the intent and the process. 

2 So maybe we're all right as we -- did the

3 mover and seconder agree that this is what they

4 really were intending to move and second? Yes?

5 MR. PRESLEY: That's fine.

6 DR. ZIEMER: We finally got their motion out

7 of them. 

8 Ted, now a comment.

9 MR. KATZ: Is it all right, Dr. Ziemer, if I

10 just make a comment? 

11 I'm a little bit concerned about this

12 language, because the public might read this --

13 despite the fact that we know what you're driving

14 at here, the public might read this as the Board

15 saying, in effect, we want you to specify the

16 models. And that could be a problem, then, in

17 terms of producing a final rule, and maybe that

18 rule being challenged if someone in the public

19 then says, well, NIOSH didn't do what its

20 Advisory Board said.

21 DR. ZIEMER: Thank you. It's certainly not

22 our intent to do that, so we may need to think of

23 some words to modify this to make it clear that

24 we simply want to -- we want to indicate -- want

25 them to indicate how they will decide what models
63 

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1 to use, I guess is the issue, right? 

2 Jim, can you help us with some words here?

3 DR. MELIUS: Well, I don't have wording, but

4 I think what we want to do -- we have in our

5 first recommendation a process for how they would

6 change to a new model.

7 DR. ZIEMER: Yes.

8 DR. MELIUS: It would come back to the Board

9 and go through that process. So I think we want

10 to just indicate for this current -- at the

11 current time, presently, what models they will be

12 using. I think we want some language just to

13 indicate that they should be scientifically --

14 reflect current state of the science in this

15 area.

16 DR. ZIEMER: So you're suggesting that this

17 might even go so far as to say so as to clearly

18 indicate that they intend to use current models

19 at the time that the rule is adopted?

20 DR. MELIUS: Yeah.

21 DR. ZIEMER: Because there is a provision

22 for changing the models.

23 DR. MELIUS: Right. And I don't think --

24 are there any models that are just very recently

25 adopted, that there'd be some concern or question
64 

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1 about?

2 DR. ZIEMER: Ted, can you answer that?

3 MR. KATZ: We don't think so. I think

4 that'll be all right.

5 UNIDENTIFIED: That’s what you’re using

6 (inaudible).

7 DR. ANDERSON: Is there any risk that in the

8 future ICRP won't be the ultimate source of

9 models, and that there might well be a –

10 DR. ZIEMER: Well, that --

11 DR. ANDERSON: I mean, this ties them into -

12 - it's you're going to use ICRP.

13 DR. ZIEMER: Well, they're currently tied

14 into that here anyway, and that's pretty

15 problematical. I don't know that we should try

16 to deal with that. 

17 DR. MELIUS: Yeah, but again, the process --

18 DR. ZIEMER: Right.

19 DR. MELIUS: -- would allow that to be

20 (inaudible) –

21 DR. ZIEMER: Right. I think it's a good

22 suggestion. 

23 Why don't you just give us a motion to amend

24 here, and what words would you put in there to

25 indicate that NIOSH -- to clearly indicate that
65 

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1 NIOSH intends to use current models at the time

2 of the adoption of the rule-making, or something

3 like that?

4 DR. MELIUS: Yeah, I think just to clearly

5 indicate that NIOSH intends to use current ICRP

6 models.

7 DR. ZIEMER: Do we need to say at the time

8 of the adoption of the rule-making, or --

9 DR. MELIUS: Okay.

10 DR. ZIEMER: No?

11 DR. MELIUS: I don't think so, but we've --

12 I don't have any objections to that.

13 DR. ZIEMER: Let's just formalize this.

14 This is a motion to amend. 

15 Is there a second?

16 DR. DEHART: Second.

17 DR. ZIEMER: Any discussion?

18 (No response)

19 DR. ZIEMER: All in favor to amend, say aye.

20 (Affirmative responses)

21 DR. ZIEMER: Any opposed?

22 (No response)

23 DR. ZIEMER: Now the motion before us is

24 number five, as written. Okay, let's vote.

25 All in favor, say aye.
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1 (Affirmative responses)

2 DR. ZIEMER: Any opposed?

3 (No response)

4 DR. ZIEMER: The motion carries. Number

5 five is adopted.

6 Let's see, four was dropped. Can we move --

7 where you have number one there, where you say

8 add, can you do a cut and paste now and stick

9 that up with the original part of number one so

10 we can see that? 

11 Now you can move that number one up to where

12 the original one was. Pound sign one, right.

13 Pound sign one at the beginning. We’re sort of

14 distinguishing between the three questions in the

15 inventory numbers here. And then you can drop

16 the word “add” there at the end, then. 

17 This has already been adopted. We just

18 wanted to get it all together. Did we pass the

19 second -- yeah, I thought we did. But I think

20 there was -- somebody wanted to make a comment.

21 Ted, did you want to make a comment on this?

22 MR. KATZ: I would, thank you. You may want

23 to consider the statement in there, all methods

24 proposed -- this is in the second paragraph --

25 will result in significant bias in favor of the
67 

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1 claimant. And –

2 DR. ZIEMER: Wait, hold on. We're not there

3 yet, Ted.

4 MR. KATZ: Okay.

5 DR. ZIEMER: That's a separate item. That's

6 a separate item.

7 MR. KATZ: Sorry.

8 DR. ZIEMER: Did you have a comment on just

9 that first paragraph? Okay, that's fine.

10 One, two, three; four was dropped; five

11 we've done. Six is the Privacy Act issue and the

12 researchers. And Henry, is this your --

13 DR. ANDERSON: Yeah.

14 DR. ZIEMER: Okay. Henry is making a motion

15 that we say except as provided under -- this

16 would say the Advisory Board recommends that

17 Section 82.28(b) be revised so as to state that;

18 and then the words would be, quote, “except as

19 provided for under the Privacy Act, researchers

20 will not receive names,” et cetera.

21 So that's your motion?

22 DR. ANDERSON: Yes.

23 DR. ZIEMER: Is there a second?

24 MR. ESPINOSA: Second.

25 DR. ZIEMER: Now wasn't there already a
68 

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1 Privacy Act statement in there?

2 DR. ANDERSON: It starts in there, yes.

3 DR. ZIEMER: So are you suggesting that

4 paragraph (b) be replaced by these words, or how

5 would the --

6 DR. ANDERSON: No, it's the end. It's the

7 second -- it's the last sentence. You could

8 delete --

9 DR. ZIEMER: Okay. It repeats the Privacy

10 Act issue, or what?

11 DR. ANDERSON: Yes, right. And my

12 understanding was that NIOSH wanted to make it

13 clear that except for the Privacy Act,

14 categorically no names would be released.

15 DR. ZIEMER: Okay. So basically this

16 motion, if adopted, does not restrict the

17 releasing of names, but only says it will only be

18 done within the provisions of the Privacy Act.

19 DR. ANDERSON: Yes.

20 DR. ZIEMER: Rather than the complete

21 exclusion.

22 DR. ANDERSON: Yeah.

23 DR. ZIEMER: I think that was the intent,

24 right? Okay.

25 DR. MELIUS: Can I offer just a friendly
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1 amendment to clarify that? That we recommend

2 that the last sentence of Section –

3 DR. ANDERSON: Yes.

4 DR. MELIUS: -- 82.28 be --

5 DR. ZIEMER: Thank you. That, without

6 objection, will be added.

7 MS. HOMER: That this will be added to the

8 last sentence?

9 DR. ANDERSON: Yes.

10 DR. ZIEMER: Section -- put it after the

11 (b), I think, Cori, Section 82.28(b) --

12 DR. MELIUS: The last sentence.

13 DR. ZIEMER: -- last sentence be revised so

14 as to state. Okay. 

15 This now is the motion before us. Any other

16 discussion? 

17 Wanda, thank you.

18 MS. MUNN: I guess I have some concern that

19 there are other identifying demographic items

20 which would identify individuals other than just

21 their names. For example, anybody who knows my

22 Social Security number can find out who I am.

23 And so I would suggest that possibly the

24 insertion of “or other clearly identifiable data”

25 --
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1 DR. ZIEMER: Before we take that as a formal

2 motion, let me ask you a question. Does the

3 Privacy Act itself cover that kind of issue so

4 that this broad statement takes care of that? 

5 Jim, and then Larry.

6 DR. MELIUS: I think the preceding sentence

7 actually addresses Wanda's concerns. The problem

8 is that it wasn't clear that the last sentence

9 was -- that names were specifically covered, but

10 other information, as I read that sentence, would

11 be; other identifying information would be

12 covered. So I think the preceding sentence takes

13 care of your concern.

14 MR. ELLIOTT: The Privacy Act does address

15 confidential information.

16 DR. ZIEMER: Including --

17 MR. ELLIOTT: Not only name, Social Security

18 number, any personal identifiable information

19 like job title. If that's the only job title in

20 that plant, we could not use that. So it

21 addresses all of that.

22 DR. ZIEMER: Thank you. 

23 Further comments or -- yes, Henry.

24 DR. ANDERSON: Yeah, my druthers would be to

25 have deleted that sentence, because I think it's
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1 all covered in the first part. And I would

2 agree, I think one could interpret this to mean

3 that everything else would be fair game, although

4 I think legally you would be bound by the -- if

5 you said it was confidential, or identify --

6 personal -- we could say researchers will not

7 receive names of claimants or covered employees

8 or other identifying information. I don't know.

9 MR. ELLIOTT: If I could offer a suggestion

10 and a comment here. We understand what your

11 concern is with this language. If you simply

12 just ask us to clarify the intent of that

13 passage, we can do so, and we have to do so with

14 guidance from general counsel and the Privacy Act

15 officer, okay?

16 DR. ANDERSON: Yeah.

17 MR. ELLIOTT: Now this is kind of a tricky

18 entry here, and I need to get clearance and

19 guidance from both of those sources of support.

20 So don't lock me into not adding a sentence you

21 want to see added, because it could go counter to

22 what –

23 DR. ZIEMER: Yeah. So what you're saying is

24 that it may be that legally this is not the right

25 sentence anyway to put in there, or there may be
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1 a better way of doing it. And the way to get

2 around that, then, would simply be to ask --

3 DR. ANDERSON: The last sentence be

4 clarified.

5 DR. ZIEMER: -- that this be clarified.

6 DR. ANDERSON: As to the intent of it.

7 MR. ELLIOTT: That's what you want.

8 DR. ANDERSON: Yeah.

9 DR. ZIEMER: Do the mover and seconder wish

10 to withdraw that motion and make a substitute

11 motion?

12 DR. ANDERSON: Yes, I'll withdraw.

13 DR. ZIEMER: The motion has been withdrawn.

14 Do you wish to give us a substitute motion,

15 such as the Advisory Board recommends that

16 Section 82.28(b), last sentence, be clarified?

17 DR. ANDERSON: Yes.

18 MS. HOMER: Be clarified, period?

19 DR. ZIEMER: Be clarified so as to what? Or

20 clarified in regards to -- yes?

21 DR. MELIUS: In regards to the coverage of

22 the Privacy Act for that information?

23 MR. ELLIOTT: That's fine.

24 DR. ANDERSON: Yeah, that's good.

25 DR. ZIEMER: Okay, who's moving that?
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1 Henry, that's your new motion, right?

2 DR. ANDERSON: I will, yes.

3 DR. ZIEMER: Thank you. Who seconded

4 Henry's new motion?

5 MR. ESPINOSA: Second.

6 DR. ZIEMER: Okay. In just a moment you'll

7 get to see what your motion is.

8 DR. ANDERSON: That got it. That's it.

9 DR. ZIEMER: Thank you. 

10 Any discussion on this?

11 (No response)

12 DR. ZIEMER: All in favor, say aye.

13 (Affirmative responses)

14 DR. ZIEMER: Any opposed?

15 (No response)

16 DR. ZIEMER: Motion carries. Thank you. 

17 Now have we covered all the inventory items?

18 DR. ANDERSON: I think so.

19 DR. ZIEMER: With the exclusion of the three

20 broad questions? Okay. 

21 Now I'd like to have us get the words of the

22 -- the proposed words of the three broad

23 questions before us. I think the word “interim”

24 there, does that start number one?

25 MS. HOMER: Yes, it does. Well, it starts
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1 what Ms. Wunn –- Ms. Munn submitted to me.

2 Excuse me.

3 DR. ZIEMER: It's almost easier to say

4 Wanda, isn't it?

5 MS. HOMER: Wanda.

6 DR. ZIEMER: Yes, Wanda, please. Could you

7 repeat what you just said?

8 MS. MUNN: Those two paragraphs were

9 intended to cover all three of the issues that

10 were placed before us.

11 DR. ZIEMER: Right, thank you for clarifying

12 that. 

13 In a sense, Wanda has integrated her

14 comments to cover the three paragraphs. We need

15 to determine whether or not we should simply say

16 that we're commenting on all three with sort of a

17 set of statements, or whether we will in fact at

18 some point break them back down into three

19 pieces. But we're looking at, I think, three

20 paragraphs -- for the moment, let's put a one

21 there, if we might, just -- so we have one, which

22 right now is in two paragraphs; and then the

23 number two there is the next part. 

24 So that's what we would have before us as a

25 sort of starting points as general comments on
75 

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1 the three questions.

2 MS. MUNN: Actually, I believe we have

3 number three also, don't we? I think that's --

4 DR. ZIEMER: Is there a --

5 MS. MUNN: Someone wrote --

6 DR. ZIEMER: Well, that number three is --

7 oh, yes. Okay, right. Okay. Now we have --

8 right now we do have those three general sets of

9 comments.

10 Now just for procedural matters let me just

11 ask someone to move those three, and we'll just

12 have them before us, and then we'll discuss them.

13 DR. DEHART: I move.

14 DR. ZIEMER: And we're not going to -- as I

15 said, I'm going to specify that we not vote on

16 these. We may not vote on them till after lunch,

17 even. But I want to get them out here, discuss

18 them. 

19 I also want to have opportunity for public

20 comment not only on these items, but just other

21 comments that might be -- again, reminding

22 members of the public if you do wish to comment

23 and haven't done so, please get your name on the

24 comment roster. We're actually scheduled for

25 public comment, I think, in 15 minutes. 
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1 So we have a little time for some

2 preliminary discussion here.

3 DR. DEHART: Are you wanting a motion?

4 DR. ZIEMER: Yes.

5 DR. DEHART: I would propose the motion.

6 DR. ZIEMER: Okay.

7 MS. MUNN: Second.

8 DR. ZIEMER: Motion to adopt these four

9 paragraphs. Is there a second?

10 MS. MUNN: Second.

11 DR. ZIEMER: Okay. Now discussion. And for

12 convenience, you might want to just talk about

13 them a paragraph at a time, although realizing

14 there's a sense in which there's some integration

15 here it may not be fully possible. 

16 Comments? Roy, please.

17 DR. DEHART: I don't know whether it's

18 appropriate to try to incorporate a single answer

19 to the three questions, but I like the concept of

20 doing that. And in fact, item number three

21 listed there is appropriately covered by the

22 second paragraph.

23 MS. NEWSOM: Dr. Ziemer, might I suggest you

24 read those into the record?

25 DR. ZIEMER: Okay, read them into the
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1 record. Let me ask the officer of the Board, the

2 Federal officer, to read them into the record.

3 New title.

4 MR. ELLIOTT: Okay.

5 DR. ZIEMER: I was trying to think of that

6 official title, but I knew you were a Fed and I

7 knew you were some kind of an officer, so --

8 MR. ELLIOTT: You can call me whatever you

9 wish to call me.

10 (Reading) Number one, interim proposed rule

11 42 CFR Part 82 makes appropriate use of current

12 science in reconstruction of radiation dose

13 scenarios to the extent practicable. The Board

14 recognizes that if the efficient and expeditious

15 consideration of claims is to be made, absolute

16 precision is not possible. All methods proposed

17 will result in significant bias in favor of the

18 claimant, and in that regard are consistently

19 conservative. 

20 The process for involving the claimant is

21 fair and provides multiple opportunities for

22 interaction with the involved agencies. Indeed,

23 in cases where acceptably dependable exposure

24 data do not exist, the claimant or claimant

25 family may be the only source available to
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1 provide information that could form the basis for

2 dose reconstruction. This circumstance

3 automatically injects a high but unavoidable

4 level of uncertainty into the calculation.

5 However, we view the proposed methods for

6 addressing these cases to be as equitable as

7 reasonably achievable at this time.

8 Number two, the interim rule outlining

9 methods for radiation dose reconstruction uses a

10 number of innovative, scientifically sound, and

11 implementable techniques which make the dose

12 reconstruction process efficient without the loss

13 of proper decision-making information.

14 Number three, the Board agrees that the

15 interim rule implements an appropriate process to

16 involve the claimant, from the formal claims

17 application to interview to feedback on the

18 specific dose reconstruction.

19 DR. ZIEMER: Thank you. So this is the

20 motion before us. 

21 It occurs to me that we have the makings of

22 a new acronym here, AERA, As Equitable as

23 Reasonably Achievable. Why not.

24 (Laughter)

25 DR. ZIEMER: Okay, let's have discussion.
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1 Is implementable not a word? Why is that under -

2 -

3 MS. HOMER: It doesn't recognize it.

4 DR. ZIEMER: It doesn't recognize it as a

5 word. Okay.

6 DR. ROESSLER: It doesn't recognize NIOSH,

7 either. So what?

8 (Laughter)

9 DR. ZIEMER: Jim, did you have a comment?

10 DR. MELIUS: Yeah. I object and don't

11 believe that the third sentence of the first

12 paragraph is accurate. I don't believe that all

13 methods result in significant bias in favor of

14 the claimant and et cetera. I think there may be

15 some that are -- I guess I don't like the term

16 “bias,” but depending on how it's defined, but I

17 think there are some parts of the methods that

18 are conservative, but certainly not all of them

19 are. So I would actually propose striking that

20 sentence. I don't believe it's necessary to

21 answer certainly the first question.

22 I also object to the -- it really it starts

23 with the third sentence of the second paragraph,

24 which is also the last sentence. I don't believe

25 that using a claimant or claimant family as a
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1 source of information automatically injects a

2 high level of uncertainty. An easy example of

3 that would be that the claimant or claimant's

4 family points out that John Doe worked with Bob

5 Smith, and that that then leads NIOSH to look at

6 John -- look at Mr. Smith's exposure records and

7 use them to reconstruct a dose estimate for John

8 Doe. So I think there's a lot of circumstances

9 there where that would not automatically have a

10 high level of uncertainty. And again, I don't

11 think that that section is necessary here.

12 DR. ROESSLER: I'd like to agree with Jim on

13 the first point in particular. And I think one

14 way to get rid of what I think are two

15 objections. The “all methods” -- this is in the

16 third sentence in the first paragraph there --

17 that “all methods” part and the significant bias.

18 I really don't like the word “bias” in here,

19 because it has a scientific meaning and it has a

20 kind of a general meaning. So I think his

21 suggestion to just delete the paragraph might

22 work. Or if not, we can change some of the words

23 -- sentence, that last sentence.

24 DR. ZIEMER: Let me ask the Board at this

25 time, do you wish the Chair to entertain specific
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1 motions to change this, or do you prefer to have

2 sort of a general discussion on all these points

3 and then do changes all at once?

4 DR. DEHART: Prefer a general discussion.

5 DR. ZIEMER: First, and just leave the words

6 for the moment, and then ask for formal motions

7 for amendments? Okay. 

8 Is that agreeable, and we'll come back and -

9 -

10 DR. MELIUS: Yeah.

11 DR. ZIEMER: Okay, sort of get general

12 comments first, and then we can entertain

13 changes.

14 MR. PRESLEY: Bob Presley.

15 DR. ZIEMER: Bob.

16 MR. PRESLEY: In the first sentence up

17 there, would you want to say scientific

18 technologies in reconstruction? It's just

19 wordsmithing, but it puts the words “science” and

20 “technology” there. That's just a thought.

21 DR. ZIEMER: Thank you. Keep that thought.

22 I believe the reason that was used is because

23 that's the terminology used in the question. The

24 specific question is does the interim rule make

25 appropriate use of current science, and I believe
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1 that was why the word is used. That does not

2 preclude us from saying current science and

3 technology or something, but I believe that's the

4 reason.

5 Okay, other comments?

6 DR. MELIUS: This is more in terms of an

7 additional subject that should be discussed,

8 though it would fit to some extent in the second

9 paragraph that's up there under number one. 

10 And again, going to the second sentence,

11 indeed, where cases where acceptably dependable

12 exposure data do not exist, I would like to add

13 some section there, as I mentioned before, where

14 we -- I have concerns about the ability of the

15 method to, or I guess the lack of clarification

16 on the part of NIOSH in these current regulations

17 and procedures, on how they will deal with the

18 situation where there is limited information

19 available and their ability to accurately

20 reconstruct the dose. And then again, this gets

21 into the issue of the Special Exposure Cohorts.

22 And I would be in favor of sort of working

23 from that point there, the start of that second

24 sentence, to talk about some of the uncertainties

25 and difficulties in that area. I think without
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1 necessarily focusing on the claimant or the

2 claimant family as being the source of some of

3 these issues, but rather that it's a general

4 issue that the Board and NIOSH have to wrestle

5 with in terms of doing these dose

6 reconstructions, and that there's a limited

7 ability to do that. 

8 At some point NIOSH will not be able to do

9 that, and we're presuming that the Special

10 Exposure Cohort provisions will step in at that

11 point, but we really haven't seen that yet.

12 DR. ZIEMER: Thank you for those comments.

13 And Jim, perhaps we might consider adding a

14 couple of sentences that might be developed over

15 lunch that could -- rather than try to do that

16 right here as we sit. It's a good idea, and

17 maybe get a straw man couple of sentences, which

18 if you would be willing to think about that.

19 DR. MELIUS: If it can fit on a small

20 napkin, we'll --

21 DR. ZIEMER: Right, thank you. We'll limit

22 the size of the napkins.

23 Wanda.

24 MS. MUNN: The author would like to suggest

25 a potential change for that third sentence of the
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1 first paragraph that was objected to. Would it

2 be acceptable to say the methods proposed tend to

3 favor the claimant, and in that regard are

4 consistently conservative? Would that be

5 acceptable?

6 DR. ZIEMER: You're asking the group in

7 general?

8 MS. MUNN: Yes.

9 DR. ZIEMER: And again, without doing

10 revisions at the moment, get that thought down,

11 and then we can come back. And maybe others want

12 to think about that for a little bit, as well.

13 DR. ANDERSON: Yeah, instead of the

14 consistently conservative, I'd probably use are

15 consistent with an occupational illness

16 compensation program, or the concept, something

17 like that. Because that's in the question, and I

18 think the idea here is the intent of the law.

19 This is consistent with that.

20 DR. ZIEMER: Okay. Keep that, Henry. Keep

21 that ready. 

22 Other comments on any of the paragraphs?

23 Yes, Gen.

24 DR. ROESSLER: I'm not clear what we're

25 doing. Are we looking at number one as being the
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1 answer on all three? Or are we considering all

2 three steps now with number two and number three

3 specifically answering questions two and three?

4 DR. ZIEMER: Well, I think as was indicated

5 earlier, there's a sense in which perhaps the

6 first two paragraphs sort of answer all three, so

7 right now it's not fully separated out. And it

8 may be, depending on how we modify and so on,

9 that we will just have a set of comments that

10 aren't necessarily one, two, and three, but we

11 say that in response to the three questions we

12 have the following comments, and we don't

13 necessarily say they're one to one. That's a

14 possibility. 

15 I think Wanda, who's the original composer

16 of the first two paragraphs, has indicated that

17 she has integrated her comments in a sense that

18 they sort of overlap, as I understood it. 

19 Wanda, is that not correct?

20 MS. MUNN: (Nods head)

21 DR. ZIEMER: Let's not look at these at the

22 moment as being in one-to-one correspondence with

23 the three questions in the NIOSH document.

24 Are there other comments at this point?

25 (No response)
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1 DR. ZIEMER: If there are not, I'm going to

2 declare a recess on our deliberations on this,

3 without objection. We are not tabling it, but

4 are simply -- will come back. We want to have

5 opportunity for public comment on this or other

6 matters before the lunch hour, have an

7 opportunity for you to give further thought to

8 these words during the lunch hour. And then my

9 proposal would be that we come back, either with

10 specific modifications or actions, right after

11 lunch.

12 We have no sign-ups. Let me just ask if

13 there are any comments from the public. 

14 Yes, please. Richard, if you would use the

15 front mike, and it will be easier for everyone.

16 MR. MILLER: Hi, it's Richard Miller. 

17 I just have one question. As I was reading

18 your discussion, what is the plan for -- in these

19 rules and as the committee looks at them, if you

20 have a situation where DOE has calculated a dose,

21 lo and behold, and the estimate that they come up

22 with that may be in the employee's record winds

23 up being higher based on the methods that the DOE

24 used than the methods that are applied through

25 the NIOSH dose reconstruction process, will you
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1 use the NIOSH outcome or the DOE outcome in that

2 circumstance?

3 DR. ZIEMER: I think we'll have to have the

4 staff answer that. But before they do, let's

5 also recognize that the DOE number will be a

6 point number. I think the NIOSH number's going

7 to be a distribution with a mean and several

8 standard deviations. And I guess your question

9 would be what if that 95 percent number is still,

10 say, less than the DOE number?

11 MR. MILLER: Right, if you wind up --

12 DR. ZIEMER: Point number?

13 MR. MILLER: Right, if you wind up -- if 99

14 (sic) percent is what's used as the upper

15 confidence limit, and you wind up with a delta

16 between that and what DOE came up with as their

17 estimate.

18 DR. ZIEMER: Yes. And here's Jim to -- Jim

19 Neton to answer that.

20 DR. NETON: It's our intent that we would

21 use our estimate, not the Department of Energy

22 estimate, given the fact -- and I think you're

23 alluding to a scenario where we would actually

24 not use this efficiency process, and we would

25 drop out and have to do a complete dose
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1 reconstruction on the individual rather than do

2 these conservative estimates at the two ends.

3 And if we got to that point, we would use our

4 estimate, which would be not a point estimate as

5 the Department of Energy uses, but it would be an

6 estimate with an uncertainty distribution about

7 it.

8 Also, it is unlikely that there will be a

9 one-to-one correspondence, because the Department

10 of Energy typically only from the internal dose

11 perspective calculates effective dose equivalent.

12 They don't normally calculate -- well, they will

13 calculate the dose to the highest exposed organ.

14 For instance, many of the organs that we're

15 calculating doses for are not estimated doses in

16 the Department of Energy system.

17 Also, when the IREP program runs, it uses

18 equivalent dose, not effective dose. And then

19 the radiation weighting factors that are applied

20 are applied as distributions within the IREP

21 program, which adds another level of uncertainty

22 to the estimate, thereby essentially increasing

23 the claimant's chance or probability of

24 compensation.

25 So there's a number of differences that
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1 exist.

2 MR. MILLER: Oh, I think that's right, Jim.

3 I just was posing the hypothetical, because you

4 could easily wind up with an annual dose. As you

5 -- and you're correct, the IREP model inserts a

6 dose for each year throughout the latency period

7 up to the point of the cancer.

8 DR. NETON: Right.

9 MR. MILLER: And so you're introducing a

10 distribution for each year on a, I guess, a

11 committed basis, but not an effective dose basis.

12 DR. NETON: Right. And there are no annual

13 internal doses calculated in the Department of

14 Energy system. They are assigned in that year,

15 but they're calculated over a 50-year time

16 period.

17 MR. MILLER: That's today. But prior to

18 1990 -- and correct me if I'm wrong -- the

19 Department of Energy never calculated committed

20 dose. And it only was a result both of ICRP --

21 the new ICRP that came out and the DOE’s Price22 Anderson regulations that were promulgated that

23 required the calculation of committed effective

24 dose.

25 DR. NETON: That's correct.
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1 MR. MILLER: But that's only post-1990, and

2 so I guess how would you deal with that if it was

3 pre-1990?

4 DR. NETON: Pre-1990 annual doses were not

5 calculated either for an internal perspective.

6 There were maximum permissible organ burdens or

7 maximum permissible body burden levels that can

8 be related to annual dose or a dose to the organ.

9 But in my experience, most sites did not

10 calculate an annual dose to an internal organ and

11 record it in their records. It's unlikely that

12 you'll find --

13 MR. MILLER: Well, we wind up with it with

14 those where you have relatively short biological

15 half-lives. Say you have a biological half life

16 of -- I'm quite familiar with some cases where

17 there'd, say, be 30 days or so, and so you

18 actually could and would have what is effectively

19 an annual dose. I'm just trying to figure out,

20 what do you if there's a conflict between what

21 DOE comes up with as a data set, and what you're

22 saying is there's no possibility of comparison

23 between the two?

24 DR. NETON: Right. Even if there were a

25 situation where DOE would have a higher annual
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1 dose than we were putting into our IREP input,

2 it's not intuitively obvious to me that the

3 person would be better served using the

4 distribution that we applied to the dose that had

5 a lower central tendency estimate than the point

6 estimate that the Department of Energy provided.

7 You understand what I'm saying?

8 MR. MILLER: Oh, I certainly understand it.

9 I'm just asking about what happens if you --

10 DR. NETON: Again, the short answer is we

11 would use our approach and not the Department of

12 Energy's.

13 MR. MILLER: That's the answer. Okay, thank

14 you.

15 DR. NETON: I probably should have said

16 that.

17 DR. ZIEMER: Thank you. 

18 Are there any other members of the public

19 that wish to comment? 

20 (No response)

21 DR. ZIEMER: Jim, on the board.

22 DR. MELIUS: I have a procedural issue. I

23 have done my wording, and I can give it to Cori

24 now. I don't know if you want to try to break

25 for lunch now and come back, or do we want to --
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1 DR. ZIEMER: I think we -- I wasn't sure

2 what we would have in the way of public comment,

3 so we had allowed on the calendar or on the

4 agenda 30 minutes. Obviously we have time, and

5 we can proceed. I'm quite willing that we

6 proceed. I think others are interested in

7 pushing ahead.

8 While that wording -- is this wording for a

9 modification here?

10 DR. MELIUS: Yeah, and actually fits –

11 DR. ZIEMER: Before she inserts that, would

12 you move to amend, then?

13 DR. MELIUS: Yeah, I would move to amend.

14 DR. ZIEMER: And can you read your amendment

15 to us? Before we insert it, I want to get it on

16 the floor and --

17 DR. MELIUS: Okay. This would be inserted

18 right up here –

19 MS. MURRAY: You need to be at a microphone,

20 I'm sorry.

21 DR. MELIUS: Oh, okay. And this will need

22 some further wordsmithing. 

23 (Reading) Indeed, in cases where acceptably

24 dependable personal exposure data do not exist,

25 NIOSH will utilize other sources of information
93 

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1 as the basis for dose reconstruction. This

2 approach unavoidably injects additional

3 uncertainty into the calculation of dose.

4 However, we view the proposed methods as being

5 appropriate for the available information.

6 Another paragraph: 

7 (Reading) There will be many circumstances

8 where NIOSH will not be able to estimate the dose

9 with sufficient accuracy. These circumstances

10 need to be clarified in the implementation of the

11 regulation and in the Board's review of NIOSH's

12 dose reconstruction work. Groups whose exposure

13 cannot be estimated with sufficient accuracy will

14 be candidates for Special Exposure Cohorts.

15 DR. ZIEMER: Is there a second to the

16 motion?

17 DR. DEHART: Second.

18 DR. ZIEMER: Okay, it's seconded. 

19 Now before we act on the motion, I'd like to

20 ask that it be inserted with the redline insert

21 so we keep the old words there for the group to

22 see. And then we'll have an opportunity to

23 discuss it without losing the current words.

24 Because if the amendment were to be defeated, we

25 don't want to have lost what we had. So we're
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1 going to do a redline insert.

2 While that's being typed in, let's look

3 ahead here at the agenda. The afternoon agenda

4 calls for a Board working session and discussion

5 of our comments, which is what we're doing now.

6 The only other thing on the afternoon agenda is

7 the public comment period.

8 If in fact we're able to come to closure

9 here -- in fact, let me ask the Board, do you

10 wish to continue working even if we go past 12:00

11 in order to come to closure on these items?

12 DR. ROESSLER: Yes.

13 DR. DEHART: Yes.

14 DR. ANDERSON: Yes.

15 DR. ROESSLER: It's Valentine's Day.

16 DR. ZIEMER: It's Valentine's Day, okay.

17 Then we will push ahead. 

18 Let me ask if there are any members of the

19 public who had planned to make additional

20 comments this afternoon. We don't want to

21 preclude anyone if you were saving up something

22 for this afternoon.

23 (No response)

24 DR. ZIEMER: It appears not. So we will

25 then, without objection, push ahead and try to
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1 finish, at which time we will have completed our

2 duties for this meeting, and we'll go to our

3 various Valentine's parties, which for some of us

4 will be in the airport, I'm sure.

5 MS. GADOLA: While you're working on that, I

6 had a question for Wanda. On the first sentence

7 when she -- at the end you have to the extent

8 practicable. And I'm not sure -- well, I think I

9 do know what you meant by practicable, but I was

10 sort of wondering if other people might

11 misrepresent that. 

12 DR. ZIEMER: Are you talking about the

13 current wording, or what Wanda was proposing?

14 MS. GADOLA: The one that Wanda was

15 proposing. The first sentence in number one

16 where it says that it makes appropriate use of

17 current science in reconstruction of radiation

18 dose scenarios to the extent practicable. My

19 concern was that some of the public might take

20 that as meaning, well, we only did as much as we

21 were easily able to do. 

22 And I don't think that was your intent,

23 Wanda.

24 MS. MUNN: I thought the second sentence

25 clarified that, Sally.
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1 DR. ZIEMER: Sally, were you suggesting that

2 that phrase “to the extent practicable” simply be

3 deleted, or --

4 MS. GADOLA: I was thinking maybe instead of

5 practicable, you would say possible or allowable.

6 To us it might mean exactly the same thing, but I

7 was just wondering for those in the public that

8 might be viewing this a little bit differently,

9 and they might be criticizing that while saying,

10 well, you could have done a better job if you had

11 looked a little harder.

12 DR. ZIEMER: Yeah, and I suppose one of the

13 issues on the use of the word “practicable” is

14 often -- carries with it the balance between what

15 is possible -- I mean, given enough time and

16 money a lot of things are possible. But if you

17 have to spend $5 million to reconstruct a dose,

18 that is not -- it may be possible but not

19 practical.

20 MS. MUNN: Which is why I worded this –

21 DR. ZIEMER: So it is the issue of what

22 those words mean. I think the word “possible” is

23 not the right one. What was the other one you

24 used, Sally?

25 MS. GADOLA: Allowable.
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1 DR. ZIEMER: Allowable. Why don't we ponder

2 that for a bit, and we can come back to that.

3 Are you also doing the strike-out on this -- of

4 the words that won't apply if the new thing's

5 adopted?

6 DR. MELIUS: Actually, everything below the

7 red down to number two will be struck out, I

8 think.

9 MS. HOMER: The red is the new stuff.

10 DR. ZIEMER: Yes. I'm asking what is going

11 to be stricken.

12 DR. MELIUS: Everything after the red down

13 to number two.

14 DR. ZIEMER: Okay. So if you delete that,

15 it'll still stay there with a line through it.

16 Yeah, right.

17 DR. MELIUS: Yeah, it's just a little hard

18 to keep the original without --

19 DR. ZIEMER: Right. Let me ask the court

20 recorder if -- you did get the original insert

21 words, I believe, correct? Do we need to reread

22 what this would say in the context, or are we

23 okay with what you have? There are some words

24 that are going to be struck, but -- we'll get the

25 final thing there. If we need to reread it,
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1 we'll do so.

2 MS. NEWSOM: Yeah, I think reread it before

3 you take a vote on it.

4 DR. ZIEMER: Thank you. 

5 Now let me ask Jim, is this everything that

6 you were including in your motion?

7 DR. MELIUS: Correct.

8 DR. ZIEMER: It would be to insert the red

9 and strike out the items indicated.

10 DR. MELIUS: Right. I just want to clarify,

11 I have utilized some of the wording from what was

12 originally up there, so it's a little bit -- it

13 is confusing, but --

14 DR. ZIEMER: Okay, so let's ask Larry to

15 read this as the second paragraph now. Read this

16 for the official record, that paragraph.

17 MR. ELLIOTT: (Reading) The process for

18 involving the claimant is fair and provides

19 multiple opportunities for interaction with the

20 involved agencies. Indeed, in the cases where

21 acceptably dependable personal exposure data do

22 not exist, NIOSH will utilize other sources of

23 information as the basis for dose reconstruction.

24 This approach unavoidably injects additional

25 uncertainty into the calculation of dose.
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1 However, we view the proper methods as being

2 appropriate for the available information. 

3 There will be many circumstances where NIOSH

4 will not be able to estimate the dose with

5 sufficient accuracy. Those circumstances need to

6 be clarified in the implementation of the

7 regulation and in the Board's review of NIOSH's

8 dose reconstruction work. Groups whose exposure

9 cannot be estimated with sufficient accuracy will

10 be candidates for Special Exposure Cohorts.

11 DR. ZIEMER: Might I ask, Jim, where it says

12 we may view the proper methods, was it your

13 intent to say proper or proposed methods?

14 DR. MELIUS: Proposed.

15 DR. ZIEMER: It's -- the word was

16 “proposed,” right. So that is not a change, it's

17 simply an editorial -- I think that proposes what

18 you had originally said.

19 DR. MELIUS: Yes.

20 DR. ZIEMER: The proper methods are always

21 appropriate, but proposed methods may not be.

22 DR. MELIUS: And can I just -- one other

23 clarification, that last red sentence, “with

24 sufficient accuracy may be candidates,” not “will

25 be candidates.”
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1 DR. ZIEMER: Well, “may be” will capture it,

2 I think, right? We don't know if they should or

3 not, but they may be. So consider that an

4 editorial change.

5 This now is the motion before us. Wanda,

6 comment.

7 MS. MUNN: As the maker of the original

8 motion, I am pleased to accept this revision as

9 appropriate.

10 DR. ZIEMER: Thank you. 

11 We are handling it as an amendment, rather

12 than a friendly amendment since it's rather

13 extensive. 

14 Other comments? Larry.

15 MR. ELLIOTT: As Ted rightfully whispers

16 into my ear, there's only one Special Exposure

17 Cohort, so that should be singular, not plural.

18 DR. ZIEMER: May be candidates for the

19 Special Exposure Cohort. Consider that an

20 editorial change, as opposed to an amendment.

21 Other comments? Henry.

22 DR. ANDERSON: Do you want to just address

23 paragraph two? I have a suggested change for the

24 third sentence in paragraph one, I think.

25 DR. ZIEMER: Right now the motion before us
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1 is this item in red, plus the strikeout. We'll

2 deal with that. 

3 Any other comments on this change or

4 modification of paragraph two?

5 (No response)

6 DR. ZIEMER: If not, let's vote on the

7 amendment to modify paragraph two as shown. 

8 All in favor, say aye.

9 (Affirmative responses)

10 DR. ZIEMER: Any opposed?

11 (No response)

12 DR. ZIEMER: The motion carries. 

13 Now we're back to the original motion, as

14 amended, which is the items one and two and

15 three.

16 Henry, you have something on paragraph one.

17 DR. ANDERSON: (Inaudible)

18 DR. ZIEMER: This would be -- Henry, would

19 you read for us –-

20 DR. ANDERSON: I’ll read it. What I have –

21 MS. MURRAY: At a microphone.

22 UNIDENTIFIED: Use the mike.

23 DR. ZIEMER: You can use the podium mike. 

24 DR. ANDERSON: What I propose --

25 DR. ZIEMER: This will be inserted as the
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1 second to last sentence in the first paragraph.

2 DR. ANDERSON: Yes. It would say the

3 methods proposed are intended to result in dose

4 estimates favorable to the claimant, and are

5 appropriate to the occupational illness

6 compensation program envisioned by the EEOICPA --

7 which is the legislation.

8 DR. ZIEMER: Okay, that's a motion to amend.

9 Is there a second to that?

10 MR. ESPINOSA: Second.

11 DR. ZIEMER: Seconded. So we'll do a

12 redline strikeout of those words here.

13 (Comments off the record)

14 DR. ZIEMER: A comment from Ted Katz.

15 MR. KATZ: This is again largely editorial,

16 but down below in the second paragraph we have

17 right now -- and this is courtesy, in part, from

18 Josh, Department of Energy -- but we say there

19 will be many circumstances where NIOSH will not

20 be able to estimate the dose with sufficient

21 accuracy. Those circumstances -- you can break

22 that into two sentences, for one; and I would

23 just add, you may want to consider also, instead

24 of prejudging whether there's many or some, you

25 might just want to say there will be
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1 circumstances, rather than quantifying them.

2 DR. ZIEMER: Thank you, Ted. Actually, as I

3 look at this, that is a run-on sentence,

4 editorially. I don't see any dangling

5 participles, but it is a run-on sentence. And

6 without objection, we should insert a period

7 after “accuracy” and then start a new sentence,

8 “Those circumstances.”

9 The point on whether there will be many, I

10 suppose is problematical. Is there any objection

11 to leaving out the word “many?” Any objection?

12 (No response)

13 DR. ZIEMER: Without objection, that

14 editorial, there will be circumstances where

15 NIOSH will not be able to estimate the dose with

16 sufficient accuracy. 

17 Gen.

18 DR. ROESSLER: Should the word be “may”

19 instead of “will?” We don't know for sure there

20 will.

21 DR. ZIEMER: Well, and certainly “may” is

22 inclusive of both the zero and every other --

23 without objection, that's an editorial change.

24 DR. MELIUS: I object.

25 DR. ZIEMER: There will be?
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1 DR. MELIUS: I think there will be. It's

2 hard for me to imagine where there will not be,

3 given all our discussions here.

4 DR. ZIEMER: So you'd rather leave it in as

5 –

6 DR. MELIUS: The legislation provides for

7 that. There already is a Special Exposure Cohort

8 where that's, I think –

9 DR. ZIEMER: Thank you.

10 DR. MELIUS: -- what Congress presumed. 

11 DR. ZIEMER: Okay, so there is objection to

12 that. So the only way we'll change that is by

13 motion. Are you making a motion?

14 DR. ROESSLER: (Shakes head)

15 DR. ZIEMER: No. Okay. Where there's a

16 will, there's a way. There will be

17 circumstances. Okay.

18 Now is there any strikeout -- this was --

19 DR. ANDERSON: Yes, the last sentence.

20 DR. ZIEMER: Last sentence gets stricken.

21 So that the proposed amendment is to insert what

22 I said was the second to last sentence, now will

23 become the new last sentence, since we will

24 strike out the previous last sentence. And the

25 new paragraph one reads as follows.
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1 MR. ELLIOTT: I'm getting better at this,

2 aren't I?

3 (Reading) Number one, interim proposed rule

4 42 CFR Part 82 makes appropriate use of current

5 science in reconstruction of radiation dose

6 scenarios to the extent practicable. The Board

7 recognizes that if the efficient and expeditious

8 considerations of claims is to be made, absolute

9 precision is not possible. The methods proposed

10 are intended to result in dose estimates

11 favorable to the claimants and are appropriate to

12 the occupational illness compensation program

13 envisioned by EEOICPA.

14 DR. ZIEMER: That motion is before us. 

15 Any comments? Wanda.

16 MS. MUNN: My only comment is with respect

17 to the original use of the word “conservative.”

18 I think one of the things that is sometimes

19 confusing to readers other than technical readers

20 is what does conservative mean. And in these

21 cases, I believe both the intent and the

22 application of these methods was to be

23 conservative, to give the claimant the benefit of

24 the doubt. 

25 So I'm wondering if it's possible to insert
106 

NANCY LEE & ASSOCIATES

1 that so that the sentence would read the methods

2 proposed are intended to result in dose estimates

3 favorable to the claimants, comma, are

4 conservative, comma, and are appropriate to the

5 -- does that confuse the issue?

6 DR. ANDERSON: Yeah, your point is exactly

7 why I did it. Conservative could be cautious, or

8 it could be as you said. That's why I put it in,

9 favorable to the claimant. It's maybe not

10 concise language, but the idea was conservative,

11 as you said, can be interpreted to be -- can

12 either be high or low.

13 DR. ZIEMER: Normally probably would be

14 interpreted as being the lower one. But maybe a

15 way to get around this and meet Wanda's comment

16 would be to say that the -- get the sentence here

17 -- dose estimates -- result in conservative dose

18 estimates, parenthesis, favorable to the

19 claimants, parenthesis.

20 DR. ANDERSON: Sure.

21 MS. MUNN: Yes.

22 DR. ZIEMER: That's one way. I'm not

23 proposing that; don't insert it. It's just one

24 way to do it. Roy.

25 DR. DEHART: (Inaudible)
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1 DR. ZIEMER: Use the mike there, Roy.

2 DR. DEHART: To get rid of the parenthetical

3 phrase, why not say results in dose estimates

4 that are consistently conservative and favorable

5 to the claimant?

6 DR. ZIEMER: Henry, does that -- is that a

7 friendly amendment?

8 DR. ANDERSON: I do have somewhat of a

9 problem. Consistently conservative, again,

10 suggests to me low. And it's favorable then to

11 their health, but not necessarily to their --

12 DR. ZIEMER: So you're speaking -- you'd

13 rather not have the word “conservative” in there.

14 DR. ANDERSON: I just think the

15 “conservative” -- I understand what you're

16 getting at, but I just think that's problematic.

17 DR. ZIEMER: Wanda.

18 MS. MUNN: And that's exactly why I used it

19 the way I did in the original sentence, that it's

20 intended to favor the claimant, and in that

21 regard is consistently conservative. I wanted to

22 tie the word “conservative” to the “favorable to

23 the claimant.”

24 DR. ZIEMER: Other comments? Gen.

25 DR. ROESSLER: I tend to go along with
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1 Henry. I think introducing the word

2 “conservative” at all, even trying to kind of

3 explain it, is confusing. I think we’ve really

4 captured it here by just saying estimates

5 favorable to the claimants, as long as that's

6 grammatically correct.

7 DR. ZIEMER: Other comments? Do you --

8 DR. ANDERSON: Just a question, and I don't

9 remember, is “conservative” used anywhere in the

10 proposed rule?

11 MR. ELLIOTT: I do not believe we’ve used

12 the term “conservative” in the proposed rule.

13 But you did see it used in the draft

14 implementation guidelines, which I have a big

15 issue with, and you won't see it in the next

16 version that you have presented.

17 DR. ZIEMER: That may answer the question.

18 DR. ANDERSON: That answers the question.

19 DR. ZIEMER: Are you ready to vote? 

20 Okay, all who favor amending the document in

21 paragraph one as shown, by the addition of the

22 redlined paragraph and the deletion of the -- or

23 sentence, rather, and deletion of the indicated

24 sentence, say aye.

25 (Affirmative responses)
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1 DR. ZIEMER: Opposed?

2 (No response)

3 DR. ZIEMER: Okay. 

4 Now we're back to the document as amended.

5 We've looked at paragraph one, paragraph two.

6 Let's see, and then we have a paragraph which has

7 a number two, which is paragraph three. That's

8 all right, leave it as it is for the moment. 

9 The interim rule outlining methods and so

10 on, anything on this paragraph? Gen.

11 DR. ROESSLER: That was my wording before

12 Wanda tried to capture everything in the first

13 part. And right at the moment, unless somebody

14 thinks it adds something, I think it's redundant.

15 And so I think it should be deleted.

16 DR. ZIEMER: The motion then would be to

17 delete this third paragraph, which carries the

18 number two. Is there a second?

19 MS. MUNN: Second.

20 DR. ZIEMER: Do we need to -- well, let's

21 just line that out, just so we have it there

22 before us, so we'll do a strikeout on that for

23 the moment. This is a proposed motion by Gen

24 Roessler to strike that paragraph, second by

25 Wanda.
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1 Discussion?

2 (No response)

3 DR. ZIEMER: Those who favor deleting this

4 paragraph, say aye.

5 (Affirmative responses)

6 DR. ZIEMER: Opposed?

7 (No response)

8 DR. ZIEMER: Okay, it's deleted. 

9 Third -- fourth paragraph, carrying number

10 three.

11 DR. MELIUS: Can you go back? I can't

12 remember what's the first sentence of the second

13 paragraph. I think again number three is

14 redundant, I think, with the first sentence of

15 the second paragraph.

16 DR. ZIEMER: Therefore you are proposing --

17 DR. MELIUS: I move that we drop that number

18 three.

19 DR. ZIEMER: Motion to drop that paragraph.

20 DR. DEHART: Second.

21 DR. ZIEMER: Seconded. We'll do a strikeout

22 here, and ask for comments on that proposed

23 amendment.

24 (No response)

25 DR. ZIEMER: Ready to vote? 
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1 Those who favor dropping this paragraph,

2 which is also a sentence, say aye.

3 (Affirmative responses)

4 DR. ZIEMER: Opposed?

5 (No response)

6 DR. ZIEMER: And that drops off the map. 

7 Now let's back the screen down so we can see

8 what's left on that document. No, no, the other

9 way, please. I just want to get those first two

10 paragraphs before us -- there. 

11 So what you have on the screen now, which is

12 the two paragraphs, right now constitutes the

13 Board's response to the three questions. Now I

14 ask if we have answered the three questions to

15 your satisfaction? That's a question to the

16 Board, not to the staff, to the Board.

17 (No response)

18 DR. ZIEMER: Is there anything you wish to

19 add or delete?

20 (No response)

21 DR. ZIEMER: I'm going to give you about

22 five minutes to think about that, because we're

23 going to have a comfort break here since we're

24 not having lunch. Okay, let's take a stretch

25 before we do a final vote. Five official
112 

NANCY LEE & ASSOCIATES

1 minutes; let's see if we get everybody back here

2 by then.

3 (Whereupon, a recess was taken from

4 12:04 to 12:15 p.m.)

5 - - -

6 DR. ZIEMER: I believe we're ready to vote

7 now on these two paragraphs as amended. It was

8 originally four paragraphs, now down to two, as

9 amended. Let me ask once again, are there any

10 other comments or -- yes, questions. Gen

11 Roessler.

12 DR. ROESSLER: Are we wordsmithing before or

13 after the vote, because in the first sentence we

14 discussed a possible change of the words.

15 DR. ZIEMER: Well, I think if there are word

16 changes, let's get them right now before us. If

17 they're editorial, minor, let's just go ahead and

18 do it.

19 DR. ROESSLER: Well, I think it's more than

20 editorial. I think we discussed in the first

21 sentence the words “to the extent practicable,”

22 and I don't have a suggestion for different

23 words, but I don't like the word “practicable.”

24 And I thought we were going to come back to this

25 part and discuss it again.
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1 DR. ZIEMER: I think it's appropriate now.

2 If we want to change that, let's do it now. I

3 don't know what the change would be if it's not

4 “practicable.” Is it “reasonable,” “reasonably

5 achievable”?

6 DR. MELIUS: I would just suggest dropping

7 “to the extent practicable.” I think appropriate

8 captures that idea, because part of whether

9 something's appropriate or not is whether it's

10 practical and efficient and so forth. So I just

11 don't think we need --

12 DR. ZIEMER: So that would be one way of

13 handling this, would simply be to drop the phrase

14 “to the extent practicable.” That's not a formal

15 motion yet, or was it a formal motion? Well,

16 let's hear some comments. 

17 Wanda, because this is your sentence.

18 MS. MUNN: I guess I still -- I understand

19 the issues that folks have with “practicable.”

20 But by the same token I think it's a necessary

21 prerequisite for the second sentence, because

22 what we're trying to make very clear is that

23 good, fast, and cheap, you can have any two out

24 of three. That's really what we're saying here.

25 And if you don't say “practicable” before you
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NANCY LEE & ASSOCIATES

1 talk about efficient and expeditious, then you're

2 not getting the sense of what I thought we were

3 trying to capture.

4 DR. ZIEMER: Okay, thank you. 

5 Other comments? So Wanda is urging us to

6 keep it, and Jim, I don't know if you were urging

7 -- you were suggesting as an alternative to drop

8 it. Do you object to not dropping it?

9 DR. MELIUS: No, it doesn't bother me.

10 DR. ZIEMER: Gen? Gen's okay with it.

11 Okay.

12 MS. GADOLA: Since I first --

13 DR. ZIEMER: The motion still before us is

14 the original as -- okay, wait a minute. Sally,

15 yes.

16 MS. GADOLA: Since I first brought that up,

17 I felt uncomfortable because I was afraid that

18 the public would misinterpret that. And even --

19 I still have a little bit of doubt there, I do

20 think that the rest of the information that we’ve

21 now added clarifies that word, so I feel more at

22 ease with it than I did before.

23 DR. ZIEMER: Okay, thank you. 

24 Okay, I take it that we're ready to vote,

25 then, this point, it appears. So we will be
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1 voting now on adopting these two paragraphs, as

2 you see there -- that is, with the new words in

3 red and the deleted words stricken. 

4 All in favor, say aye.

5 (Affirmative responses)

6 DR. ZIEMER: And those opposed, say no.

7 (No response)

8 DR. ZIEMER: And the motion carries. 

9 We now have adopted all of the items I think

10 that we had before us. Is there anything that's

11 been omitted?

12 (No response)

13 DR. ZIEMER: Then I would ask, if the Board

14 is agreeable, I will take these -- again, they

15 will be formatted into letter form. I may

16 rearrange the order, and may have some sentences

17 that say in response to the three questions the

18 Board has the following comments, something of

19 that sort, without changing the items that have

20 been officially approved. 

21 Is it agreeable that the Chair would have

22 the prerogative of formatting this into letter

23 form, somewhat like we did before? But it would

24 probably all be in one letter, or else a letter

25 with an appendix or an attachment, and a meeting
116 

NANCY LEE & ASSOCIATES

1 agenda, again as we did before.

2 (No response)

3 DR. ZIEMER: Without objection, we'll

4 proceed on that basis. We'll make copies

5 available to everyone. Oh, wait --

6 DR. ANDERSON: I was just thinking, I think

7 leaving this as an attachment that goes part of

8 the record is important. I wonder if in the

9 covering letter we might want to mention

10 something about that this kind of a work in --

11 the dose reconstruction as opposed to the other

12 is more of a work in progress, and that we look

13 forward to working closely with NIOSH as this is

14 implemented and our revisions are considered, or

15 things like that.

16 DR. ZIEMER: I'd be glad --

17 DR. ANDERSON: So it really is -- the proof

18 is going to be in the pudding, once it's --

19 DR. ZIEMER: Okay, I'd be glad to do that.

20 And Henry, before you leave, just write that down

21 on a piece of paper, save me from writing it

22 down. No, I certainly -- I don't mean to be

23 facetious. I just want to be sure to capture

24 your words on that, and any others that have some

25 thoughts that you want to include.
117 

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1 Also, I'm wondering if it's possible -- and

2 I'll just ask Cori, and I think at this point you

3 can go ahead and tell the machine to get rid of

4 that strikeout stuff. Is it possible to get a

5 printout of these for anyone that wants to take

6 with, or not? Maybe not. Maybe the thing to do,

7 you can e-mail these to us, can you not?

8 MR. ELLIOTT: We'll e-mail the text that

9 you've approved.

10 DR. ZIEMER: Right, not --

11 MR. ELLIOTT: So all the Board has --

12 DR. ZIEMER: I just want to make sure

13 everybody has that. You'll be able to get that

14 in the next day or two, probably.

15 MR. ELLIOTT: Yeah.

16 DR. ZIEMER: Okay, that'll be good. Is

17 everybody okay on that?

18 DR. MELIUS: Yeah, I would just -- could you

19 also share this, what we've written and the

20 process and so forth, with Tony, who couldn’t be

21 here?

22 MR. ELLIOTT: Yes.

23 DR. MELIUS: Just so he's --

24 MR. ELLIOTT: Absolutely. Everything that

25 we've assembled as a product from the last two
118 

NANCY LEE & ASSOCIATES

1 days of meeting will be shared with Tony.

2 DR. MELIUS: Sort of get it to him, and I

3 don't -- if there was additional comments or

4 questions he has, I think we should just try to -

5 - you know.

6 DR. ZIEMER: Now everybody's okay on that

7 process, then?

8 (No responses)

9 DR. ZIEMER: One final thing I'd like to

10 request if the staff is able to do this, and

11 maybe to have general counsel or somebody that's

12 available to you, I would like to see if we can

13 find out precisely what the FACA rules are for

14 advisory committees, as opposed to Federal

15 agencies, on this issue of predecisional drafts,

16 the extent to which we can work individually and

17 exchange information. 

18 Not that we're going to, because our work is

19 done; but if we have situations like we had last

20 time, I'd like to find out exactly -- because

21 I've heard several versions from different

22 members of the public on exactly what the

23 requirements are, and the comments I've gotten

24 are completely 180 degrees apart. I don't know

25 what the legal requirement is on that.
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1 Obviously we're going to try to make

2 everything as public as possible. But there's a

3 sense in which you come to a screeching halt if

4 you can't work sort of off-line at times.

5 MR. ELLIOTT: We certainly will get a

6 counsel's guidance and committee management's

7 guidance on that, and we'll send it to you.

8 DR. ZIEMER: And we want to do whatever's

9 both fair to the Board and to the public.

10 MR. ELLIOTT: Understood.

11 DR. ZIEMER: Just to find out what is the

12 requirement.

13 Are there any other items that need to come

14 before us?

15 DR. DEHART: I don't know whether you care

16 to mention it or not, but this was with unanimous

17 consent.

18 DR. ZIEMER: The record will show that these

19 things were adopted with unanimous consent,

20 recognizing that one of our members is absent.

21 Tony is not here today.

22 MR. ELLIOTT: And just for everyone's

23 reminder, the public comment period remains open

24 for dose reconstruction rule 82 CFR -- 42 CFR 82

25 until March 1st. Once your letter has been sent
120 

NANCY LEE & ASSOCIATES

1 forward to the Secretary, it also will be added

2 that day to the docket on this rule. Public

3 comment can be received until March 1st.

4 DR. ZIEMER: Thank you. 

5 Any other items that need to come before us?

6 Any other comments for the good of the order?

7 (No response)

8 DR. ZIEMER: Any other public comments?

9 (No response)

10 DR. ZIEMER: If not, we stand adjourned.

11 MR. ESPINOSA: Paul, just --

12 DR. ZIEMER: Hold on, hold on just a moment,

13 because --

14 MR. ESPINOSA: Because of the public

15 interest in this and people coming from out of

16 town and out of state, is there any way that the

17 Board can reserve more rooms?

18 MS. HOMER: Well, the difficulty with

19 putting more rooms on a block is that we just

20 don't know for sure who's going to be on there.

21 MR. ESPINOSA: Is there any way or any

22 manner that --

23 DR. ZIEMER: Use your mike, please.

24 MR. ESPINOSA: Is there any way or any

25 manner that people that are interested in this
121 

NANCY LEE & ASSOCIATES

1 can get in contact with NIOSH, CDC?

2 MS. HOMER: They can contact me. The

3 difficulty is in setting up the contract. I'd

4 have to let them know at the time I'm arranging

5 the contract how many people will be attending.

6 All I can do is guarantee an estimated amount

7 based on the Board's attendance and staff

8 attendance. So if I know ahead of time, I can

9 tell them.

10 MR. ELLIOTT: We certainly would appreciate

11 hearing from folks who want to attend the

12 meeting, but we cannot provide them space. We

13 can help them -- we can identify other hotels

14 that they might be able to get space in. But it

15 helps us to have advance notice of who wishes to

16 attend the meeting, and we'll try to assist them

17 in what ways we can.

18 DR. ZIEMER: Thanks.

19 DR. ANDERSON: Just one last --

20 DR. ZIEMER: Henry.

21 DR. ANDERSON: What is our process -- I

22 think we had some ideas about the next meeting

23 and what we'd like to see. And how are we going

24 to -- what's our process to get things on the

25 agenda for the next meeting and subsequent
122 

NANCY LEE & ASSOCIATES

1 meeting?

2 DR. ZIEMER: Right. We agreed that if you

3 had suggested individuals or groups that you

4 wanted to hear from, we would let Larry know what

5 those are, either by individual or by agency or

6 topic. Larry and I would work up an agenda which

7 we'll share with the group in a draft form to see

8 if -- and this is for the April meeting, now,

9 we're talking about and --

10 UNIDENTIFIED: May.

11 DR. ZIEMER: Yeah, the April meeting, which

12 will be held in May. And I think that's what

13 we've agreed on. Is that --

14 MR. ELLIOTT: Yeah.

15 DR. ZIEMER: Okay. Thank you, everyone.

16 We'll see you next time. Be sure to give Larry

17 your time sheets, as it were, and calendars to

18 Cori.

19 (Whereupon, the meeting was

20 adjourned at 12:29 p.m.)

21 - - -

22

23

24

25
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1

2

3

4

5
124 

C E R T I F I C A T E

STATE OF GEORGIA )

 )

COUNTY OF DEKALB )

I, KIM S. NEWSOM, being a Certified Court

Reporter in and for the State of Georgia, do hereby

certify that the foregoing transcript, consisting of

120 pages, was reduced to typewriting by me

personally or under my direct supervision, and is a

true, complete, and correct transcript of the

aforesaid proceedings reported by me.

I further certify that I am not related to,

employed by, counsel to, or attorney for any parties,

attorneys, or counsel involved herein; nor am I

financially interested in this matter.

WITNESS MY HAND AND OFFICIAL SEAL this 7

th day of

March, 2002.

__________________________

_

KIM S. NEWSOM, CCR-CVR

CCR No. B-1642

(SEAL)