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 I

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 Wednesday, February 13, 2002.
2 

C O N T E N T S

VOLUME I

February 13, 2002

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

REGISTRATION AND WELCOME 

Dr. Ziemer ...................... 6

Audience Introductions ............ 7, 45, 217

REVIEW AND APPROVAL OF DRAFT MINUTES

Dr. Ziemer ...................... 9

PROGRAM REPORT

Mr. Elliott ..................... 10

RECAP OF ADVISORY BOARD COMMENTS ON PROBABILITY 

OF CAUSATION RULE (2 CFR PART 81)

Dr. Ziemer ...................... 47

STATUS ON IMPLEMENTATION OF DOSE RECONSTRUCTION 

RULE (42 CFR PART 82)

Mr. Neton ...................... 56

IMPLEMENTATION OF EXTERNAL DOSE RECONSTRUCTION 

GUIDELINES

Mr. Taulbee ..................... 93

IMPLEMENTATION OF INTERNAL DOSE RECONSTRUCTION 

GUIDELINES

Mr. Allen ..................... 130

PUBLIC COMMENT PERIOD

Mr. Bob Alvarez .................. 182

Mr. Richard Miller ................. 190

BOARD DISCUSSION/DEVELOPMENT OF COMMENTS ON

DOSE RECONSTRUCTION RULE (42 CFR 82) ......... 217

ADJOURN ....................... 269

CERTIFICATE OF REPORTER ................ 271
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. (Absent)

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

INVITED SPEAKERS

DAVID ALLEN

Health Physicist

Office of Compensation Analysis and Support

National Institute of Occupational Safety and Health

JAMES NETON, Ph.D., CHP

Office of Compensation Analysis and Support

National Institute of Occupational Safety and Health

TIMOTHY D. TAULBEE, MS, CHP

Health Physicist

Office of Compensation Analysis and Support

National Institute of Occupational Safety and Health
5 

NIOSH STAFF/VENDORS

CHRIS ELLISON, NIOSH

RUSS HENSHAW, NIOSH

CORRINE HOMER, NIOSH

TED KATZ, NIOSH

MARIE MURRAY, Writer/Editor

KIM NEWSOM, Certified Court Reporter

TWILA SAITOW, NIOSH

AUDIENCE PARTICIPANTS

BOB ALVAREZ

NEIL BARSS

LYNNE FAIROBENT

MARK GRIFFON

JEFF HARPER

LIZ HOMOKI-TITUS

WILLIAM EARL JOHNSON

ALICE KELLEY

JEFFREY L. KOTSCH

SONYA LEVINE

MARTIN MATHAMEL

TIM McADAMS

RICHARD MILLER

FRANK MORALES

FRANK MORAN

LOUISE S. PRESLEY

JOSH SILVERMAN

CRISTAL THOMAS

WILLIAM D. ULICNY
6 

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

2 8:31 a.m.

3 DR. ZIEMER: Good morning, everyone. I want

4 to officially open the second meeting of the

5 Advisory Board on Radiation and Worker Health.

6 The Board members are here in the front at the

7 table, and I'm not going to introduce them all.

8 They were introduced last time. For members of

9 the public, the names of the Board members and

10 the support staff are on the tents, as they are

11 called, just in front of each person. 

12 Let the record show that all of the Board

13 members are here, with the exception of Tony

14 Andrade. And if I'm -- I'll ask the court

15 reporter, I'm going to go off record just a

16 moment.

17 (Off the record)

18 DR. ZIEMER: Now back on the record, there

19 are sign-up sheets at the entry. If you have not

20 already signed in, please do that. For members

21 of the public, there is also a sign-up sheet if

22 you wish to make public comments during that

23 portion of the agenda. We ask that you sign up

24 simply so we have an idea of how many plan to

25 comment and we can apportion the time
7 

NANCY LEE & ASSOCIATES

1 accordingly.

2 One instruction for the Board members on the

3 use of the mikes this time. Your mikes have a

4 push-button in the front, and when you speak

5 you'll need to flip that button to the on

6 position and then turn it back off when you're

7 not speaking so that we eliminate feedback.

8 I'd also like to point out to everyone,

9 particularly members of the public, there are

10 handouts on the table over in the far corner, and

11 those handouts represent some -- both background

12 material as well as material that may be used by

13 presenters during the program today and tomorrow.

14 Although I'm not introducing the Board

15 members individually this morning, we do, for the

16 record, want to have our guests -- that is, the

17 members of the public -- introduce themselves,

18 and if you're representing an organization, to

19 identify who that is. This information will

20 likewise be in the public record. So if we could

21 start on the far side and have each person there

22 stand. If you speak loud enough, you may not

23 have to use the mike, but the court reporter will

24 try to get that information. Please identify.

25 Thank you.
8 

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1 MR. ULICNY: Bill Ulicny with ATL

2 International.

3 MR. MORALES: I’m Frank Morales with the

4 Government Accountability Project.

5 MS. FAIROBENT: Lynne Fairobent with the

6 American College of Radiology.

7 MR. BARSS: Neil Barss, SAIC.

8 MR. KOTSCH: Jeff Kotsch. I’m a health

9 physicist with the energy group at Labor.

10 MR. JOHNSON: Earl Johnson, representing the

11 ATLC, Atomic Trades and Labor Council, at Oak

12 Ridge.

13 MS. SAITOW: I’m Twila Saitow, I’m with

14 NIOSH.

15 MS. PRESLEY: Louise Presley, spouse of Bob

16 Presley.

17 MS. HOMER: Cori Homer, NIOSH.

18 DR. ZIEMER: Okay, and there are some staff

19 members. Maybe the other staff members sitting

20 in the back could go ahead and identify for us

21 also.

22 MS. HOMOKI-TITUS: Liz Homoki-Titus, Health

23 and Human Services, General Counsel’s Office.

24 MR. HENSHAW: Hi, I’m Russ Henshaw, NIOSH,

25 Office of Compensation Analysis and Support.
9 

NANCY LEE & ASSOCIATES

1 MR. KATZ: Ted Katz, NIOSH.

2 MS. ELLISON: Chris Ellison, NIOSH.

3 MR. TAULBEE: Tim Taulbee, health physicist

4 at NIOSH.

5 DR. ZIEMER: Thank you very much. So

6 consider yourselves all introduced at this point.

7 We're glad to have all of you here this morning.

8 You'll note -- oh, make sure you have an

9 agenda. If you haven't already picked one up, I

10 believe there are copies on the back table as

11 well.

12 The first item on our agenda is the approval

13 of the draft minutes of the last meeting. We've

14 set aside a full 30 minutes to do this. I don't

15 think it'll take that long since we don't have

16 the draft minutes. We can debate about them, but

17 due to the fact that there has been such a brief

18 time since our last meeting, it's simply not been

19 feasible for those minutes to be prepared and

20 distributed. So the only comment I will make,

21 and I will -- without objection, we will delay or

22 defer the action on those minutes until our next

23 meeting.

24 The only comment to make is, for members of

25 the public, if you wish to have copies of the
10 

NANCY LEE & ASSOCIATES

1 minutes, they will be available to you as well.

2 But there is a sign-up book for you on the table

3 so that if you wish to have copies of those draft

4 minutes, please sign up and those will be

5 distributed to you as well, when -- once they are

6 ready.

7 I'm going to ask the staff -- maybe I lost

8 Cori there -- but are there any other

9 announcements that need to be made at this

10 moment? I think not. If others arise, we'll

11 make them as we learn of them.

12 The first item on today's agenda, then, is a

13 program report by Larry Elliott of the NIOSH

14 staff. And Larry, I don't know if you want to

15 come up here and make your report, that'll be

16 fine.

17 MR. ELLIOTT: Well, good morning again, and

18 it's a pleasure to be with you all again on such

19 a short turnaround and short response time

20 between meetings. I'm very pleased to be able to

21 meet with you again and to take on the additional

22 business of the Board.

23 Dr. Ziemer and I, in preparation of your

24 agenda, had talked about what's called -- what

25 we're calling a program report, just to let you
11 

NANCY LEE & ASSOCIATES

1 know a little bit of information about what goes

2 on within the Office of Compensation Analysis and

3 Support at NIOSH. I think I tried to tailor this

4 presentation to give you that understanding, but

5 in the context of where you fit in and what has

6 been going on since the Act was passed, what's

7 been happening at NIOSH in support of

8 implementing our responsibilities. And this

9 information, I hope, will give you a sense of

10 what's forthcoming both for not only for the

11 program but for the Board as well in its work in

12 reviewing dose reconstructions.

13 Frankly, we're running on the ragged edge.

14 Our products that we're now providing to you are

15 preliminary in draft, but in order to achieve our

16 goals, a goal of promulgating two rules by the

17 first -- or by April; I hope it'll be the first

18 of April and not the last part of April. We find

19 ourselves in this dilemma where even our program

20 books for today -- I'm glad nobody showed up

21 yesterday -- we're short-staffed, and we're

22 extremely tasked right now to keep ahead of the

23 curve. And I think that's where the Board's at.

24 I’ve really put a lot on your shoulders to read

25 through all of the material that we provided and
12 

NANCY LEE & ASSOCIATES

1 get an understanding of the direction that we're

2 trying to take this program, and make sure that

3 we bring along your understanding of that

4 direction and hear what your thoughts and

5 comments are. 

6 So that's the intent and the purpose of this

7 program report, just to kind of set the stage and

8 give you a little bit broader context of

9 understanding about what's going on with this

10 program and NIOSH's responsibilities, and your

11 role in assisting us in those responsibilities.

12 So I'm going to go through a very brief time

13 line here. The Act was passed in October of

14 2000. There were several people that were tasked

15 immediately after its passage to start thinking

16 about NIOSH's responsibilities as they might be

17 delegated through the Department to us. In March

18 of 2001 six people were detailed on special

19 assignment to craft the implementation policy and

20 guidelines and development of the rules. 

21 We had a reorganization of NIOSH that was

22 approved in July of last year that established

23 this new Office of Compensation Analysis and

24 Support within NIOSH. That reorganization plan

25 that was approved included 22 full-time
13 

NANCY LEE & ASSOCIATES

1 equivalent positions, and I'll talk about those

2 in a moment, but just to give you a sense of how

3 few people are working to do such great things on

4 this whole program.

5 We prepared the charter for this Advisory

6 Board and got it through concurrence, and it was

7 signed in August, shortly after OCAS was

8 established. Then we come forward and published

9 our notice of proposed rule-making for guidelines

10 on determining probability of causation, the 42

11 CFR 81 that you reviewed and commented upon last

12 meeting and during your teleconference. We also

13 published an interim final rule on dose

14 reconstruction methodology, and that was

15 presented as 42 CFR 82.

16 And there's a reason why we went in

17 different tracks with these two rules. The

18 notice of proposed rule-making on probability of

19 causation required you, by statute, to review and

20 comment on it. It was open for 30 days for

21 public comment period. We reopened that comment

22 period to coincide with the last Board meeting,

23 retained the docket open for your comments up

24 until February 6th.

25 The rule on dose reconstruction was an
14 

NANCY LEE & ASSOCIATES

1 interim final, and that regulatory process track

2 allowed us to start working on dose

3 reconstructions immediately while the rule was

4 being finalized, during public comment and to the

5 point of finalization.

6 In October, October 11th, we received the

7 first batch of claims from the Department of

8 Labor. For us to receive a claim from the

9 Department of Labor, what has to happen is two

10 criteria are met: The claim has to have had the

11 employment for the energy employee verified by

12 DOL turning to Department of Energy and seeking

13 that verification that the individual actually

14 worked at the site or sites they claim. Second

15 criteria test is medical diagnosis. The claim

16 has to present a confirmed diagnosis, either a

17 death certificate or a clinical diagnosis of the

18 cancer. Then the claim is verified as eligible

19 and sent to us.

20 On October 19th the President made

21 announcement about your appointments to this

22 Advisory Board. So a lot has happened in a short

23 amount of time up to this point. Now a lot more

24 has happened.

25 The first batch of acknowledgment letters –
15 

NANCY LEE & ASSOCIATES

1 and I'll talk about the steps in our process in a

2 moment -- but this is significant and remarkable

3 in that we're trying to -- we're working with

4 batches of claims, and we're trying to turn

5 batches through steps in the process as

6 expeditiously as possible. So the first step is

7 get the claim from DOL, the second step is to

8 send a letter to the claimant letting them know

9 that we have their claim in our hands, and they

10 can contact us at this point to verify status of

11 the claim.

12 As I mentioned, the public comment period

13 for the dose reconstruction rule closed on

14 November 5th. We reopened it again during your

15 last meeting, and it is now open again for public

16 comments on the dose reconstruction rule. That

17 will close on March the 1st.

18 The first batch of requests for personal

19 monitoring information data that were sent to the

20 Department of Energy on November 27th. This is

21 on individual claims seeking dose information,

22 badge results and bioassay information from the

23 Department of Energy to start our initial

24 evaluation of the dose reconstruction process for

25 that claim.
16 

NANCY LEE & ASSOCIATES

1 The public comment period for guidelines on

2 determining probability of causation were again

3 closed on December -- and as I mentioned, they

4 reopened. We've reopened them to coincide with

5 your meeting. 

6 On December 20th we conducted the first

7 claimant interview as an expedited interview.

8 Well, expedited the interview because the

9 claimant was wanting to share their work history

10 with us before they passed, and we thought it was

11 beneficial to get that and accommodate that

12 situation.

13 On December 27th of 2001 the first batch of

14 letters informing claimants that we had gone to

15 DOE seeking information regarding their claim

16 were sent out. Again, we reopened the public

17 comment period. That's throughout this.

18 You all met in January, on the 22nd and

19 23rd, and I know that was a hectic two days with

20 a lot of information provided. Again, the public

21 comment period closed on those rules, and we've

22 again reopened them.

23 Let me talk a little bit about the staff. I

24 mentioned 22 FTEs approved. Not all 22 are

25 filled. I'm blessed by having a very competent,
17 

NANCY LEE & ASSOCIATES

1 exemplary staff. You met Dave Sundin last

2 meeting. You know Jim Neton from last meeting;

3 he'll be here shortly. Martha DiMuzio, you

4 checked in last meeting, she was here. Nichole

5 Herbert was also here as my secretary. They're

6 not here today. They're back tending to business

7 in Cincinnati. Jim will be here shortly, as I

8 mentioned.

9 And our technical support team, you met Russ

10 Henshaw last time. David Allen, who will be here

11 shortly this morning to present to you later.

12 Grady Calhoun you met last time; he's back in the

13 office for this meeting. Tim Taulbee's here

14 today. He'll be presenting to you, another

15 health physicist on staff. We have a couple of

16 vacancies in guise of a statistician and an

17 office automation assistant for this team.

18 Then we have a records management team

19 comprised of these individuals. You met Trudy

20 Zimmerman last time, I believe. And we have

21 Paula McCreary, who's an office automation

22 assistant or a secretary to this team; computer

23 specialist Nancy Kuo. Chris Ellison's here

24 today, who's a health communications specialist,

25 and a very vital job she performs for us. She's
18 

NANCY LEE & ASSOCIATES

1 responsible for our web site, and if you haven't

2 -- if the public hasn't been there yet, I'd

3 encourage you to get on there. We have a lot of

4 good information there for you, and I think it's

5 only going to get better. And we have a number

6 of vacancies shown here as well.

7 We've augmented gaps where we need

8 assistance in technical support by bringing

9 contractors in, and I've listed those as well. I

10 just want to give you -- share this level of

11 information with you to give you a sense of how

12 few people are doing the great things that are

13 going on.

14 I'm going to talk about the steps in this

15 process now so that you get a sense of this, and

16 I'm also going to give you a sense of what we're

17 facing. What you don't see at these meetings,

18 what a lot of people don't see, is the face on

19 this program, the claimants. And my folks have

20 to deal with those folks every day, and it's

21 tough.

22 Right now we understand that there's more

23 than 12,000 non-Special Exposure Cohort cancer

24 claims staged in some point of verification of

25 eligibility for the claim, ready to come to us.
19 

NANCY LEE & ASSOCIATES

1 That number may decrease. It may increase,

2 depending upon whether verification is achieved

3 or not on an individual claim.

4 In step one, as I mentioned, the claims come

5 to us once they're verified. This kind of

6 portrays how we saw those claims coming to us

7 during these months, and gives you a sense of the

8 increase by months that we're seeing. These

9 numbers -- all the numbers I'm presenting to you

10 are as of last Friday.

11 Step number two involves sending a letter to

12 the claimant letting them know that we have their

13 claim in our hands, and we're beginning the

14 process of dose reconstruction. The letter tells

15 them that this point in the process they do not

16 have to give us information. We'll be seeking

17 them out to find information. 

18 The first thing we're doing is we're

19 evaluating our own records for information

20 relevant to their claim, making an informed

21 decision about what we need in addition to that,

22 and then we're taking the next step to go to DOE

23 to get the dose information. And so that's shown

24 in step three, and this is where we're at as far

25 as sending information requests to Department of
20 

NANCY LEE & ASSOCIATES

1 Energy, only for badge-related data and bioassay

2 data.

3 In step four we also follow back up with the

4 claimant to let them know what we're doing, that

5 we've approached DOE for the personal dose

6 information that we think they should have and we

7 need to start the dose reconstruction with.

8 In step five, this represents the number of

9 claims that DOE has responded to us with

10 information, and these keep trickling in all the

11 time.

12 In step six, this is where we do the initial

13 review of that information provided to us by DOE,

14 in conjunction with whatever we had in our hands,

15 and make a decision do we have enough, given what

16 we've been provided and what we have from our own

17 holdings, or do we need to go back to the DOE

18 site and request specific information that'll

19 fill a gap or an information need in pursuing a

20 dose reconstruction to completion?

21 We've conducted, as I said, only one phone

22 interview, so you see the numbers are decreasing.

23 We're now getting to the apical point, top of the

24 pyramid, if you will, of where we're at with all

25 of this.
21 

NANCY LEE & ASSOCIATES

1 We've gone back to DOE at this point in time

2 with 21 additional requests for information, and

3 we're going to have to work with DOE to pursue

4 that additional information that we want.

5 How many dose reconstructions have we

6 completed to date? None. That's relying upon us

7 finalizing the rule, getting your assistance in

8 doing that.

9 So as we proceed through today's business, I

10 want you to keep in mind what we are asking of

11 you. We need your review and comment on the dose

12 reconstruction rule. I call your attention again

13 to the three questions at the start of that rule.

14 I've tried to help, through this presentation,

15 frame what I think we're doing with regard to

16 those questions, that we are being interactive

17 with claimants, we are seeking information from

18 DOE. The presentations you're going to get

19 shortly from Jim Neton and Tim Taulbee and Dave

20 Allen are going to take you in a little bit more

21 detail into dose reconstruction methodology.

22 We're advancing that to you because we need

23 to make sure that we're off in the right

24 direction. We also need to make sure that we

25 bring along everybody on this committee with the
22 

NANCY LEE & ASSOCIATES

1 same level of understanding. If there's one

2 member of the committee that feels that they

3 don't have a grasp of the direction that we're

4 going with this, we need to work together to make

5 sure we all bring everybody along together on

6 this.

7 This is important, I think, because not only

8 are there legal interests here in processing a

9 claim to final adjudication, but there's also

10 technical interest here to do it right. And so

11 when we're talking about accuracy of doing dose

12 reconstruction, we're talking about giving an

13 accurate answer in the dose reconstruction input

14 parameters that go into the IREP to make a

15 determination for that claimant.

16 We've also had a number of phone calls

17 coming into the office -- and this is something

18 else we're dealing with on a day-to-day basis.

19 We're going to have to deal -- look at how the

20 Department of Labor handles their customer

21 service, and we're examining models and methods

22 to react to the number of phone calls that we're

23 getting. We're trying to get our web site page

24 up where a claimant can tap into that and find

25 out the status of their own claim, and we're
23 

NANCY LEE & ASSOCIATES

1 striving to get that in place.

2 We anticipate a number of claimants might

3 want to visit our offices. In Cincinnati we're

4 at the crossroads of three interstates, and we're

5 in the back yard of three sites, four sites.

6 We're not that far from Oak Ridge. We know

7 people are going to be driving by and thinking,

8 oh, I'll just stop in there and see my claim.

9 I'm concerned about this because of how we

10 present ourselves, but also because of security.

11 There's money vested interests here. People want

12 to know when they're going to get it and how soon

13 they're going to get it. And we're dealing with

14 some people who are deserving, and they're also

15 as well frustrated in trying to understand this

16 process. So we're going to accommodate those

17 visits, and we're going to do our best to provide

18 good customer service to these folks.

19 We provided a copy of the amendments to the

20 Act in your briefing booklet. These are fixes

21 that were put together and attached as amendments

22 in the Defense Authorization Act passed in

23 December. One of those things that came to us

24 from these amendments is this need to do a

25 residual contamination study of the atomic
24 

NANCY LEE & ASSOCIATES

1 weapons employers, with these two purposes in

2 mind. So this is not something the Board is

3 engaged in or is asked to review on. We want you

4 to know we are doing it, though, and we think it

5 will inform our efforts on dose reconstruction as

6 we proceed with AWE claims.

7 We are bound to do our level best to try to

8 meet the intent of Congress here, and provide

9 reports back to them on this time frame as

10 they've asked for. We have contractors in place

11 who are doing this work right now.

12 So that's for your information, to give you

13 a little broader context of what's going on with

14 the program. Hopefully you'll see some

15 information here that might aid you in your

16 deliberation about answering the questions in the

17 rule. And if there are any questions, I'll

18 respond.

19 DR. ZIEMER: Larry, let me begin the

20 questions, and we'll open it up for others, but

21 first I'd like to ask about the staffing levels.

22 Are the staffing levels that you showed us --

23 once you fill those vacancies, are those seen as

24 being adequate to handle this program once it's

25 going full-fledged, or do you anticipate further
25 

NANCY LEE & ASSOCIATES

1 staffing increases?

2 MR. ELLIOTT: This was the initial plan --

3 DR. ZIEMER: But it must have been based on

4 an anticipated number of claims. Based on what

5 you're seeing, are we on track?

6 MR. ELLIOTT: It was based on 8,000 claims

7 in the first year. The plan was to augment

8 technical support and expertise as necessary

9 through contracting mechanisms. We have a dose

10 reconstruction request for proposals on the

11 street right now, which the proposals are due

12 next -- the 20th, next week. That contract will

13 support the bulk of the work on dose

14 reconstruction, with this staff providing the

15 oversight of that effort. We're going to have to

16 wait and see as to whether or not we need

17 different skills and different positions to be

18 brought into the staff to handle what maybe we

19 didn't anticipate. But we had -- you know,

20 depending on how this goes and what our

21 experience and understanding base becomes, we

22 could go back and ask for additional support.

23 DR. ZIEMER: Roy DeHart, and then Jim.

24 DR. DeHART: Roy DeHart. 

25 Two questions, Larry. The Special Exposure
26 

NANCY LEE & ASSOCIATES

1 Cohort is going a different track, at least now.

2 MR. ELLIOTT: The Special Exposure Cohort

3 guidelines are being -- have been prepared as

4 policy guidelines. They are in the Office of the

5 Secretary for review and concurrence right now.

6 What the Office of the Secretary decides to do

7 with them is their discretion. They may come

8 back at us to finalize as policy guidelines, or

9 they may say we think it better to go with a

10 proposed rule here. So we're waiting to see what

11 the Secretary's desire is.

12 DR. DeHART: Thank you. The second

13 question, you're telling me that the initial

14 letters are going in to the Department of Labor,

15 reviewed for the two criteria, then coming to

16 you, and then going to DOL. Why can't that be

17 short-cut?

18 MR. ELLIOTT: I may have confused you. The

19 claim is submitted to the Department of Labor

20 through the use of the forms that they have

21 provided to the claimants. The eligibility is

22 verified by the employment and then the medical

23 diagnosis. Then if that happens, the claim is

24 verified eligible, DOL sends the claim to us for

25 dose reconstruction. We're going to DOE then to
27 

NANCY LEE & ASSOCIATES

1 obtain information on dose, badge data and

2 bioassay data that can be used. We're not going

3 back to Labor, so I may have confused you with

4 that.

5 DR. DeHART: No, I'm sorry, I was confused

6 on the question. What I don't understand, what

7 role are you playing in the interim between the

8 two, between the Department of Labor to you and

9 then sending to DOE? Could Labor not simply go

10 to DOE and ask them to start looking at exposure?

11 MR. ELLIOTT: We think it's important that

12 we make that step because, first of all, we've

13 proposed that we have a number of research data

14 in our hands from prior studies of some of the

15 sites, in order to diminish the impact upon DOE,

16 and they're getting considerably impacted by

17 requests for information, not only from the

18 Federal side of the program but from the state

19 comp side of the program as well. 

20 It made more sense to us to get the claim,

21 understand what the cancer was, where they

22 worked, and then make the approach to the sites

23 with the specific requests for information that

24 we need. We didn't feel it appropriate to rely

25 on Labor to do that in advance of sending it to
28 

NANCY LEE & ASSOCIATES

1 us.

2 DR. ZIEMER: Jim.

3 DR. MELIUS: Yeah, Jim Melius. 

4 You can defer this question if you're going

5 to present it later or if you think it's more

6 appropriate, but I have some questions regarding

7 how you make a determination that the records

8 received from DOE are incomplete. Now I believe,

9 based on the process so far, you're doing that

10 based on what you receive back from DOE, because

11 you haven't really interviewed more than a --

12 well, I guess you've interviewed just the one

13 worker. Are you going to be talking about that

14 later, because I think that's sort of a critical

15 question.

16 MR. ELLIOTT: I can answer that now, and

17 then hopefully that will be embellished more with

18 the presentations you're going to get. 

19 We see this as a progressive set of steps to

20 accrete information necessary to develop the case

21 file. And as I said, first we check our in-house

22 holdings, then we approach DOE for just a

23 straightforward, personal dosimetry information -

24 - badge data and bioassay data. And this is

25 designed to accommodate our need for efficiency
29 

NANCY LEE & ASSOCIATES

1 in turning the claims around. 

2 And Jim will talk, and Dave and Tim will

3 talk about this a little bit as well in their

4 presentations, how do we achieve that efficiency

5 if a claim is -- apparently the dose is high

6 enough, and we add what missed dose that we can

7 readily add and move that through the process

8 toward final adjudication and getting a decision,

9 that makes sense to us. 

10 Likewise, if the dose that we get back from

11 DOE and the relative information needed to

12 complete a dose reconstruction, and the worst13 case scenario applied there would never achieve

14 an award, we need to know that and we need to

15 tell the claimant that as soon as possible so

16 that we avoid frustration on their part.

17 It's the middle group that we're going to

18 focus our attention on, on doing comprehensive

19 dose reconstructions on. We bring the interview

20 of the claimant into that process after we've got

21 the first batch of information back from the

22 Department of Energy. So once we've got the dose

23 on an individual, we may go back to DOE

24 requesting more information, but we're going to

25 take the next step with the claimant interview
30 

NANCY LEE & ASSOCIATES

1 and start pulling that information together. We

2 may go back to DOE more than once on an

3 individual claim.

4 How do we verify what we've got from DOE?

5 Is that part of your question, how do we test the

6 veracity of that information? If you've gone

7 through the implementation guides you'll see some

8 of the underlying assumptions there, some of the

9 types of information beyond personal dose

10 monitoring information that we feel we need to

11 seek to better our understanding and be more

12 complete in our dose reconstruction process.

13 We're working on an MOU with Energy to gain

14 access to this information. We feel that's -- we

15 interpret the Act to -- that is their

16 responsibility to provide us access and provide

17 the information necessary to do complete dose

18 reconstructions. So this is being worked out.

19 It's not fully there yet.

20 DR. MELIUS: Do you have a time table for

21 that, because I think it's going to -- I'm not

22 sure where the process is, but I think it's going

23 to be hard to sort of assure that you've received

24 everything unless you've worked out some sort of

25 an arrangement with DOE that I won't say
31 

NANCY LEE & ASSOCIATES

1 guarantees that, but ensures a complete effort on

2 their part.

3 MR. ELLIOTT: I don't have a time table to

4 present to you. There are a number of different

5 efforts, that the culmination of those efforts I

6 hope are going to happen all about the same time,

7 in April. I'm not prepared today to talk about

8 how that time line looks for any given individual

9 effort, and when and where we might find

10 ourselves on-track or off-track.

11 DR. ZIEMER: Gen Roessler.

12 DR. ROESSLER: My question's about the dose

13 reconstruction contractor. You've already

14 answered part of that, but it seems to me this is

15 -- it's very important, as I read through the

16 documents, to make sure that whoever's doing that

17 work, almost on an individual basis, remains

18 objective. Because there's some details that

19 just really that we have to, I think, as a Board

20 assure that that's happening. Who looks at the

21 proposals and selects the contractor?

22 MR. ELLIOTT: This is done according to

23 government procurement standards. There is a

24 technical review team that has been established -

25 - my staff represents the bulk of that team -- to
32 

NANCY LEE & ASSOCIATES

1 review all the proposals. Then there's a

2 business review that the procurement office

3 conducts. There's weighting factors associated

4 with the proposals. There's an evaluation guide

5 that is prepared to evaluate the proposals

6 against, and it's on a point basis. And then we

7 have the -- we have a -- in that process there's

8 a deliberation of who to award to, and

9 negotiations are started toward the award. The

10 award will be made, the decision for an award

11 will be made jointly by the program and the

12 procurement office.

13 DR. ROESSLER: And then I think you answered

14 this question. Once the contractor is selected,

15 then your staff provides the oversight?

16 MR. ELLIOTT: That's right.

17 DR. ROESSLER: And is that pretty much an

18 ongoing --

19 MR. ELLIOTT: Yes.

20 DR. ROESSLER: -- all the time sort of -- I

21 don't imagine it would be looking at individual

22 decisions?

23 MR. ELLIOTT: We will be. We will be doing

24 it --

25 DR. ROESSLER: You'll be looking at--
33 

NANCY LEE & ASSOCIATES

1 MR. ELLIOTT: We'll be doing dose

2 reconstructions blind against the contractor. We

3 will also be doing -- in our quality control

4 program with the contractor we'll be evaluating a

5 sample of dose reconstructions. And you play a

6 role in your responsibility to review dose

7 reconstructions. So that's something we're going

8 to have to talk about, how do we frame that work,

9 how does that happen.

10 DR. ROESSLER: I don't think you have enough

11 people.

12 MR. ELLIOTT: Well, I appreciate those

13 comments. But this is for information, and just

14 to give you an insight and a context to work

15 from. And believe me, I understand where I'm at,

16 and we're trying to do the best we can, and I

17 have great people doing great things.

18 DR. ZIEMER: And I might insert, Gen, and

19 you may recall at our last meeting we talked at

20 least briefly about the fact that this Board will

21 probably need to establish a working group of

22 some sort to look and sample the dose

23 reconstructions as, in a sense, part of a quality

24 control to satisfy ourselves that they are being

25 appropriately done. So I think it's likely that
34 

NANCY LEE & ASSOCIATES

1 we ourselves will have some sort of ongoing role

2 in that process.

3 Yes, Wanda, I believe, has a question.

4 MS. MUNN: Yes. Larry, this may be

5 premature, given the state of where we are. But

6 if I understood your presentation, about one7 fifth of the cases you have received from DOE

8 have had to involve some sort of additional

9 interaction with them?

10 MR. ELLIOTT: We've gone back for additional

11 information, yes.

12 MS. MUNN: And I guess what I'm wondering is

13 whether you consider this just start-up issues,

14 getting the program off and rolling, or do you

15 anticipate that over the long haul that might

16 signify about the number of double feedback

17 interactions that --

18 MR. ELLIOTT: I think it's too early, it's

19 too premature to make any type of interpretation

20 of these statistics I've shown you today. We are

21 getting underway. It's an evolving process.

22 MS. MUNN: I understand.

23 MR. ELLIOTT: We are working with Energy to

24 assist them in enabling their sites, and the

25 people who respond to our requests understand
35 

NANCY LEE & ASSOCIATES

1 what it is we want. Some of these that you see

2 are AWEs, and while we got all the information

3 right now from DOE that DOE has, we still feel

4 the need to go after some additional information

5 that the AWE might have and may not have.

6 MS. MUNN: Yeah.

7 MR. ELLIOTT: Some of these that you see

8 here that went back to DOE were simply where they

9 didn't -- the point of contact at a given site

10 didn't understand what it was we were seeking,

11 and sent us cumulative dose, as an example. 

12 So this is premature to use these numbers to

13 try to do trend analysis, but we are collecting

14 these kinds of statistics. We're monitoring. We

15 know how many claims are at DOL for a given site.

16 We get a monthly update on those, so we kind of

17 target what the work load looks like for a given

18 site when we talk about doing profiles of a site.

19 So there are these kinds of informative

20 statistics that are going to be forthcoming, but

21 we're not here yet to be able to interpret all of

22 those.

23 DR. ZIEMER: Bob Presley, I think, has a

24 question, and then Jim.

25 MR. PRESLEY: Bob Presley. 
36 

NANCY LEE & ASSOCIATES

1 Larry, are they -- is there an effort

2 underway to broaden the Special Cohort facilities

3 in any way?

4 MR. ELLIOTT: Well, that's the Special

5 Exposure Cohort guidelines, petitioning process

6 guidelines that I mentioned earlier, that we have

7 developed and are in the Department in review.

8 DR. MELIUS: To follow up on Genevieve's

9 question from earlier, and one part of it you

10 answered, the other you didn't. How do you deal

11 with potential or perceived conflicts of interest

12 with your dose reconstruction contractor? Is

13 there a process similar to, I guess, what the

14 Board's gone through in terms of handling those

15 situations, or how do you do that or plan to do

16 that?

17 MR. ELLIOTT: The RFP calls for a plan in

18 the proposal from -- to speak to this point, how

19 will conflicts of interest be handled by the

20 contractor, should they be awarded. There are

21 several other deliverables besides just -- within

22 the proposal besides that plan, a quality control

23 plan. This is a conflict of interest plan. How

24 will they address somebody who works at a given

25 site, or somebody who is on their staff who was
37 

NANCY LEE & ASSOCIATES

1 involved in radiation protection program at a

2 site or maintaining records at a site, and how

3 will they handle avoiding perceived conflicts of

4 interest of individuals dealing with those?

5 Once we get the proposals in we evaluate

6 those plans, and we will negotiate with the

7 individual awardee on what we think the proper

8 plan should be.

9 DR. MELIUS: Can I follow up on that? Will

10 there then be a final plan that would be a public

11 document or part of -- available as part of the

12 process so a claimant would understand that if --

13 MR. ELLIOTT: Yes.

14 DR. MELIUS: Okay.

15 MR. ELLIOTT: Yes. Yes.

16 DR. ZIEMER: Henry Anderson.

17 DR. ANDERSON: Just quickly, you're tracking

18 individually the process and the recall issue,

19 and you have flags in there on time lines.

20 Because I could see you sending a batch of

21 requests into a specific facility, and very

22 quickly you might get back some, but then some

23 don't come back from that batch. And then what

24 flags do you have that maybe they're having

25 difficulty or there's some problem? Because I
38 

NANCY LEE & ASSOCIATES

1 think you'll get a kind of a standard curve of

2 response times, and the tail that's out there --

3 MR. ELLIOTT: Right.

4 DR. ANDERSON: -- you want to be sure that

5 you're aware when a problem has developed,

6 because you may then go into your alternative

7 exposure –

8 MR. ELLIOTT: Right. Absolutely, good

9 question. And even those we're dealing with

10 these on batch basis, once we send off to DOE, we

11 watch and monitor on an individual claimant

12 basis. We're asking DOE to turn a response

13 around to us in 60 days whether they can find the

14 information or not. In 60 days' time on each

15 individual claim, we need to hear back from DOE

16 on where they're at. Now if they find the

17 information we've requested in advance of 60

18 days, certainly we've encouraged them to send us

19 that information on an individual basis, not wait

20 until the batch is complete.

21 DR. ANDERSON: Okay.

22 MR. ELLIOTT: So we're monitoring each

23 claim, what its status is, has it passed the 60-

24 day mark. Then we go back to DOE and we remind

25 them if we haven't seen any action on it.
39 

NANCY LEE & ASSOCIATES

1 DR. ZIEMER: Larry, could I follow up on --

2 and this may be a question that I should be

3 addressing to someone other than you -- but do we

4 have any knowledge or sense of the extent to

5 which DOE has dedicated resources and personnel

6 to supporting this effort versus just handling

7 claims as they would anyone else in their system

8 asking for their exposure reports?

9 MR. ELLIOTT: Well, Josh Silverman's here

10 from DOE, Office of Worker Advocacy. They have

11 an office established to handle their

12 responsibilities under this program, which

13 include more than just responding to requests

14 from us. They have the physician panels they

15 have to run for the state comp program side of

16 it. I can't speak to number of staff --

17 DR. ZIEMER: I wonder, Josh, if you'd be

18 willing to comment on that briefly? Josh, are

19 you here?

20 MR. SILVERMAN: Yeah.

21 DR. ZIEMER: You don't have to if you don't

22 wish to, but if you're able to -- just for our

23 benefit, so we have a feel for what's happening

24 at DOE.

25 MR. SILVERMAN: Very briefly, we've been
40 

NANCY LEE & ASSOCIATES

1 working very closely with NIOSH and with the

2 Labor Department, and we have provided some

3 funding for major field sites for their records

4 activities. So we were concerned that this not

5 look like another unfunded mandate coming down

6 from headquarters. We are in regular

7 communication with our field sites and continuing

8 to help smooth this process. It's a new type of

9 request for many of them, and so there are many

10 issues to be resolved. But we're working on

11 that, I think closely with NIOSH and with Labor,

12 for the type of information that they need from

13 our sites.

14 DR. ZIEMER: Thank you. 

15 Other questions? Henry?

16 DR. ANDERSON: Of the -- I noticed your

17 phone calls is going up. We're early in February

18 and you're already high. What types of calls --

19 are those people wanting to call to find out

20 what's the status of my claim? 

21 And then the next question would be are you

22 thinking of having, and maybe already do, an

23 online tracking system that would then reduce the

24 calls coming in, because people would be able to

25 look and see --
41 

NANCY LEE & ASSOCIATES

1 MR. ELLIOTT: Yes.

2 DR. ANDERSON: -- where their claim is in

3 the process. 

4 MR. ELLIOTT: Yes.

5 DR. ANDERSON: Because the calls will start

6 to eat up your processing time, and it gets to be

7 a real vicious circle.

8 MR. ELLIOTT: This is -- you're absolutely

9 right. This is something I mentioned earlier,

10 that we're -- I'm very sensitive to the claimant

11 interests here, the number of calls that we're

12 getting in, the fact that we may have walk-in

13 visitors. 

14 The calls to date have been varied, from

15 exactly what you mentioned -- what's the status

16 of my claim, where's it at, what are you doing

17 with it, when can I expect a decision, why aren't

18 you moving faster? Educating people on this

19 program and the process that their claim must go

20 through is a big component of what Chris does and

21 the other folks in my office who answer the

22 phones.

23 Yes, we do plan -- I mentioned this briefly

24 in my talk -- we have one page on our web site

25 where you can get much of this information right
42 

NANCY LEE & ASSOCIATES

1 now about how many claims does NIOSH have in our

2 hands, where they're at in the process. We have

3 had a plan from the very start to allow an

4 individual claimant to enter through the web site

5 and determine their status of their claim. We've

6 had some difficulties in getting that approved

7 and set up on our web site because of Privacy

8 Act-related concerns. We've had to deal with

9 those, and we're moving forward with trying to

10 get that in place, because it will help us reduce

11 the number of contacts by telephone. It's not

12 going to do away with all of them, though. We

13 know that, and we want to be responsive to these

14 people in many ways. 

15 That's a big side of the work that we have,

16 dealing with the claimants. And we've been to

17 Department of Labor's Jacksonville District

18 Office trying to examine their operation and

19 their organization and their flow of work. They

20 have a whole group that deals with customer

21 service who answers the phone, and how do they do

22 that, and how do -- you know, we don't want to

23 leave folks hanging on the line waiting for

24 somebody to talk to them. Some of these folks

25 are elderly and can't hear very well. We need to
43 

NANCY LEE & ASSOCIATES

1 accommodate that. We're looking into all of

2 that, and we're -- I don't want to fail in that

3 regard. We're going to do our level best to

4 achieve success there.

5 DR. ZIEMER: Okay, Jim.

6 DR. MELIUS: Just one comment. I would just

7 like to ask the Chair if we can come back to some

8 of these issues, particularly regarding the

9 oversight and quality control and so forth over

10 this process. I think after we've gone through

11 the presentations, and maybe either this

12 afternoon or sometime tomorrow, we spend some

13 time on this issue, because I don't think we can

14 sort of finish our comments on dose

15 reconstruction without at least thinking through

16 and starting some discussion on those sort of --

17 our role in this process.

18 DR. ZIEMER: We most certainly will do that,

19 Jim. And after we hear the discussions -- for

20 example, the presentation by Jim Neton and others

21 -- I think some of these will flow naturally out

22 of those discussions, in any event. So we

23 certainly will keep that in mind.

24 Larry, thank you very much. This has been

25 very helpful, and I'm sure many of these issues
44 

NANCY LEE & ASSOCIATES

1 we'll be digging into in great detail as we

2 proceed.

3 MR. ELLIOTT: I appreciate that. I'd just

4 add this, that we're trying to bring you along

5 with your understanding, and I'm trying to get

6 that delivered in as non-technical laymen's terms

7 as possible so that we achieve some level of

8 transparency here and understanding. And again,

9 a lot of what I just presented is really -- I

10 want it to be information for your deliberations

11 and provide a better context. 

12 And I hope we can get to that level of talk

13 about oversight, but I really think we need to

14 focus on providing comments on the general rule,

15 and then we can work together --

16 DR. ZIEMER: Right.

17 MR. ELLIOTT: -- on these other issues in

18 the implementation guides and other things like

19 that as we proceed.

20 DR. ZIEMER: It certainly has provided for

21 us a good framework to see what sort of the big

22 picture is as your office undertakes this

23 extensive task.

24 I want to focus for a moment on the agenda

25 and point out that after our break, which will be
45 

NANCY LEE & ASSOCIATES

1 coming up shortly, we have on the agenda recap of

2 the Advisory Board's comments. That recap will

3 not take the full hour, so it's my hope that

4 we'll be able to start on the presentation of the

5 Part 42 reconstruction rule a little bit earlier

6 than shown on the agenda, because that's where we

7 need to spend our time in any event as we dig

8 into Jim Neton's presentation.

9 Before we take our break, I notice that

10 there are many more visitors and observers and

11 members of the public that have joined us since

12 our opening introductions. So several comments I

13 would make: I would ask if those who've joined

14 us, if you've not already done so please sign in.

15 There's a sign-in book out in the foyer. If you

16 wish to make public comments at that point in our

17 agenda, which is later in the afternoon, please

18 sign up in the public comment book so that we

19 know how to apportion the comment time and

20 period. Again, I'd point out that there are

21 copies of handouts on the table in the far corner

22 over here in the room, and please avail

23 yourselves of those handouts.

24 And then finally, if you were not here

25 during the introductions, we now would like to
46 

NANCY LEE & ASSOCIATES

1 ask you, observers and members of the public, to

2 identify yourselves, your name, and if you

3 represent a particular group, what that group is

4 so that we have this for the public record also.

5 MR. HARPER: My name is Jeff Harper. I’m an

6 attorney with Harper and Associates and a

7 contractor with DOE.

8 MR. McADAMS: I’m Tim McAdams. I’m a lawyer

9 with Westat and a contractor with NIOSH.

10 MR. SILVERMAN: I’m Josh Silverman with the

11 Department of Energy.

12 MS. KELLEY: Alice Kelley with the

13 Department of Health and Human Services.

14 MR. THOMAS: I’m Cristal Thomas. I’m with

15 the Office of Management and Budget, and I’m with

16 the CDC (inaudible).

17 MS. LEVINE: Sonya Levine from the

18 Department of Labor, Office of the Solicitor.

19 MR. MATHAMEL: Marty Mathamel, I’m an

20 independent environment safety and health

21 consultant.

22 MR. GRIFFON: Mark Griffon, CPS. I’m a

23 contractor with PACE International, Inc.

24 MR. NETON: I’m Jim Neton. I’m with NIOSH

25 OCAS.
47 

NANCY LEE & ASSOCIATES

1 MR. ALLEN: I’m Dave Allen. I’m with NIOSH

2 OCAS.

3 DR. ZIEMER: I want to ask the court

4 recorder, are there any of those names that you

5 were unable to get --

6 MS. NEWSOM: Yes, there were.

7 DR. ZIEMER: All of them, huh?

8 MS. NEWSOM: Several of them.

9 DR. ZIEMER: Do you need us -- or you might

10 be able to get them from the sign-up sheet.

11 MS. NEWSOM: Yes, I'll get copies of the

12 sign-up sheet.

13 DR. ZIEMER: Okay, we'll figure it out.

14 MS. NEWSOM: Thank you.

15 DR. ZIEMER: Thank you. 

16 We will now take our break, and I'd like to

17 reconvene, if we can, at about quarter of -- let

18 me see, how much -- yeah, that's about right.

19 Twenty minutes should be plenty, so at 9:45 we

20 will reconvene. Thank you.

21 (Whereupon, a recess was taken from

22 9:28 to 9:55 a.m.)

23 - - -

24 DR. ZIEMER: I pointed out to the NIOSH

25 communications person who's here today that the
48 

NANCY LEE & ASSOCIATES

1 best tool for communication, I've found out, is

2 this gavel. It really works well. We'll call

3 the meeting back to order.

4 The first topic that we have before us now

5 is the recommendations of the Advisory Board

6 relating to 42 CRF 81. For the benefit of

7 members of the public who might not have been

8 here last time or who are involved here for the

9 first time as observers, at our last meeting the

10 Advisory Board did some working group activities

11 on the second day to develop some preliminary

12 drafts for comments to be made to the Secretary

13 of Health and Human Services relating to the

14 proposed rule-making, 42 CFR 81.

15 After our meeting, the wording on -- the

16 proposed wording on our advice was further

17 refined by the working group and then distributed

18 by e-mail to the members of the Board. 

19 The final document was acted upon and voted

20 upon in a conference telephone call that was held

21 -- when was that held? It's -- the time flies so

22 fast when you're having fun, I -- yes, it was

23 recently, a week ago or so. That was an open

24 telephone call, open to the public. 

25 The final document is available -- is it on
49 

NANCY LEE & ASSOCIATES

1 the table, let me ask? It's on the table --

2 MR. ELLIOTT: Yes, it's on the table.

3 DR. ZIEMER: -- and it appears on the

4 Advisory Board's new letterhead. It looks like

5 this (indicating). It has a logo and the name

6 Advisory Board on the top. 

7 The document consists of two parts. One is

8 the letter over my signature to Secretary

9 Thompson. That letter explains what we did at

10 our first meeting. That letter also includes, in

11 the second to last paragraph, a -- what we might

12 think of as a recommendation, but really took the

13 form of a suggestion relating to the composition

14 in membership of the Board. Since the Board is

15 not specifically asked for advice on its own

16 composition, we simply put this in the form of a

17 comment, and you will see that there. It has to

18 do with the Board makeup in terms of

19 representation from the sector which we

20 identified as the nuclear production worker

21 sector.

22 And then the document includes, as enclosure

23 one, specific comments on 42 CFR Part 81. The

24 comments are grouped into three parts. Those

25 three comments are broad comments relating to the
50 

NANCY LEE & ASSOCIATES

1 questions asked in the preamble of 42 CFR 81, the

2 draft rule-making, and those comments are there

3 for your information. 

4 These have been sent to Secretary Thompson.

They were sent on February 6

th 5 . I've not yet

6 received a letter back from Secretary Thompson

7 telling me that this is the best advice he's ever

8 received, but in any event, the information has

9 gone forward.

10 I don't know if any of the committee or

11 Board members wish to make any further comments

12 on this document. Let me first ask if there are

13 any questions or comments on the document as it

14 went forward.

15 (No response)

16 DR. ZIEMER: Then I don't think -- oh, yes,

17 Henry Anderson has one question.

18 DR. ANDERSON: Just for the public that was

19 not -- I think it's important for them to know

20 that there was unanimous support for the letter

21 and the issues raised in it, so it was –

22 DR. ZIEMER: Okay, thank you for that

23 comment. Yes, all of the Board members were

24 present on the conference call, and the final

25 vote was a unanimous vote to support the content
51 

NANCY LEE & ASSOCIATES

1 of the recommendations.

2 I might add that there was some discussion

3 in the process as the Board developed various

4 drafts of the document. There was discussion

5 about how and at what point the public should be

6 involved in the process. There is indeed some

7 debate on how this should be handled in the

8 public forum. It's not clear to me that we know

9 -- it's certainly clear that our process is to be

10 open. 

11 The issue of at what point what are

12 sometimes called pre-decisional drafts are made

13 public is a question. There certainly is the

14 possibility, and maybe even the probability, that

15 the FACA rules, as applied to boards such as

16 this, may not be quite the same as the rules that

17 apply to Federal agencies as far as pre18 decisional drafts.

19 In any event, it certainly is our intent

20 that the process be open to the extent that we're

21 able. Technology may have moved ahead more

22 rapidly than even FACA anticipated, so that as we

23 get into e-mailing each other with minor and

24 major changes on documents, keeping the public

25 informed becomes problematical.
52 

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1 On this particular document it appeared that

2 at least one group had access to the wording and

3 others in the public may not have had. And in

4 fairness, I think in the future we need to think

5 of ways that, if the process is to be open, how

6 we can do that; and make documents, if they are

7 to be open, available to the public early on. We

8 were very much pressed for time, and so that some

9 members of the public did not have access to the

10 proposed comments until the time of the phone

11 call when they were read into the record.

12 And it certainly could be argued that in

13 fairness that does not give the public much time

14 to review and react, so we need to be giving some

15 thought. I think the Board needs to think about

16 it, and perhaps with input from Board members and

17 the NIOSH staff we can think about the extent to

18 which we might want to even have some comments in

19 our operational rules that we adopted last time

20 as to how to handle these sorts of things in the

21 future. And we can certainly have some comments

22 on that now. I'm not suggesting that we try to

23 solve the problem now, but certainly feedback's

24 important.

25 Jim.
53 

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1 DR. MELIUS: Well, I am just -- maybe I'm

2 jumping the gun, but if we're going to be putting

3 together comments on dose reconstruction, I think

4 we're going to have to meet -- confront this

5 issue very shortly. 

6 And my suggestion would be -- I think it's

7 simple, and Larry, you can tell me if it's

8 feasible -- is just post all the drafts and

9 comments on the web site, and as they come in.

10 And we copy Larry or whoever you want us to copy

11 on each comment, and that's posted so it's

12 public, and drafts are public. And that can be

13 done, I think, in a timely fashion, and I think

14 that -- we'd announce it at the meeting, so at

15 least people attending, the public would know

16 about what might be coming up there, and then it

17 would be available as it went along. Again, most

18 of the comments are just sort of grammatical or

19 wordsmithing or whatever, which is fine, but then

20 it's -- everyone sees it, and then there's no

21 question of what's being missed or whatever.

22 DR. ZIEMER: Yeah. And Larry, you might

23 want to comment on that.

24 But let me also insert, and then also I

25 would suggest that any public comments on the
54 

NANCY LEE & ASSOCIATES

1 comments be also public. On our particular

2 draft, I received personally comments from a

3 public group, and I think the other Board members

4 were copied on this. But it's not clear to me

5 that those comments themselves were public at

6 that point. 

7 So we did have -- those were, in a sense,

8 read into the record. We didn't verbally read

9 them on the telephone conference, but we asked

10 that they be included in the public record of the

11 telephone conference. Because I think in

12 fairness we also want the public responses to be

13 public, and not just to the Board members. So

14 it's sort of fair is fair; let's get everything

15 out in the open.

16 Larry, please.

17 MR. ELLIOTT: Yes, certainly we can put them

18 on the web site, and that would be our intention

19 to do so, and the public comments as well, as

20 they are forthcoming.

21 DR. ZIEMER: Right. In that case, any

22 comments -- we would ask that comments that come

23 in not be directed to the Board, but just write

24 to the NIOSH staff so they can be made publicly

25 available, or both, but --
55 

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1 MR. ELLIOTT: What we have to achieve here

2 is the deliberation of the Board needs to be done

3 in a public forum.

4 DR. ZIEMER: Yes.

5 MR. ELLIOTT: And so --

6 DR. ZIEMER: And so we certainly want to

7 make every effort to do that, and if this is a

8 way we can handle it readily, certainly I don't

9 think we even need to take any action other than

10 to realize that that's the process.

11 Other comments? Roy, you were wiggling here

12 a little bit. Does that mean --

13 DR. DeHART: No, I was just thinking about

14 what we did last time and what the process would

15 be this time. Would then we address our comments

16 to the other Board members as we have done, and

17 include then the address for the web site? Do we

18 need to do that, or Larry, you would pick up on

19 the address –

20 DR. ZIEMER: No, to the staff, I think, and

21 then they would put it on the web site.

22 MR. ELLIOTT: I would ask that you include

23 me and Cori on your e-mail transfers, and we will

24 make it happen on the web site. The only

25 limitation with the use of the web site is that
56 

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1 not all of the public has access to the web. And

2 so we'll have to make accommodation for telephone

3 requests for that kind of information as well,

4 and we'll have to make that announcement. 

5 We'll see how we get through here today and

6 tomorrow. Do we need another teleconference, and

7 if so, then we should talk about how we conduct

8 the business of the Board after we leave here and

9 before we have that teleconference to finalize

10 your comments.

11 DR. ZIEMER: Thank you. Other comments at

12 this point on that issue?

13 (No response)

14 DR. ZIEMER: Thank you very much. 

15 We're going to proceed, then, with the

16 presentation by Jim Neton, which gives us more

17 detail on the dose reconstruction area. And then

18 there will later be further details on both

19 external and internal dose reconstruction by the

20 other staff people. But we'll start with Jim

21 Neton, and Jim will give us sort of an overview

22 on the dose reconstruction rule.

23 Jim.

24 DR. NETON: Thank you, Dr. Ziemer. It's a

25 pleasure to be here again. I think this is my
57 

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1 third time now addressing the Board, so if you're

2 not tired of me by now, I guess you'll never be.

3 I'd like to talk today about the

4 implementation of the dose reconstruction rule

5 and provide a general overview to set the

6 framework, really, for the two presentations that

7 are to follow me. That would be Tim Taulbee,

8 who's going to address the external dosimetry

9 implementation guide, and Dave Allen, who's going

10 to address the internal dosimetry implementation

11 guide.

12 What I'd like to do is do a little bit of an

13 overview of the actual steps in the process as

14 the rule is written, and where we are in

15 fulfilling some of those steps, what we've done

16 so far; talk a little bit about the documentation

17 that we have in place to try to have a pedigree

18 for this program so that we can really document

19 well what we've done.

20 And then I don't want to belabor the point,

21 but I'd like to go over a little bit about the

22 efficiency process that we've adopted, because I

23 think that really is the heart of making this

24 program work. And I talked a little bit about it

25 last time, but I think I've got some -- a few
58 

NANCY LEE & ASSOCIATES

1 more concrete examples and some probability of

2 causation results that we can discuss.

3 And then I'd like to finish up briefly with

4 a couple of issues that are somewhat unique to

5 the program, and that would be radon. That's not

6 really a dose reconstruction issue; it's an

7 exposure assessment or an exposure

8 reconstruction. And then to talk a little bit in

9 a little more detail about the atomic weapons

10 employers.

11 There are five major steps in the rule if we

12 outline how a dose reconstruction takes place.

13 And the first of these steps is sort of obvious,

14 is to collect the existing information. And

15 there's two sources of information available to

16 us out there. 

17 Well, there's the Department of Energy

18 information that's collected at the DOE

19 facilities themselves, and that is -- that

20 information is actually owned by the Department

21 of Energy, and we're interfacing of course with

22 them, and you've heard Josh Silverman talk this

23 morning about the Office of Worker Advocacy. 

24 There's also the piece of the information

25 that's from the atomic weapons employers -- that
59 

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1 is, those contractor facilities that were not DOE

2 prime contractors, the facilities were not owned

3 by the Department of Energy; and thus, those

4 exposure records are not necessarily property of

5 the Department of Energy or NIOSH or anyone. And

6 it's a slightly different issue that I'll talk

7 about a little later in collecting that

8 information.

9 As far as collecting information, though, I

10 think -- I missed Larry's presentation this

11 morning, but I'm sure he talked about what we've

12 done so far in going out to collect personnel

13 monitoring information workers -- I mean, from

14 the Department of Energy related to workers at

15 DOE facilities. We've got a number of those

16 requests out. 

17 We've taken a staged approach to this, and

18 that is personnel monitoring information only at

19 the present time. We sense that -- it's sort of

20 an efficiency process as well. If the personnel

21 monitoring information alone can allow us to

22 perform a dose reconstruction, then that's well

23 and good, and we're not going to spend time going

24 after records that may be very difficult to

25 obtain, such as the work place monitoring
60 

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1 information, or even things such as like pocket

2 ionization chambers that workers have worn. Some

3 of the DOE facilities themselves have indicated

4 that may take a much longer period of time to

5 collect that information. 

6 So we're working it through on a staged

7 process. And I will say at a number of the sites

8 we've had some very good cooperation with the

9 contractors trying to figure out exactly what we

10 need. We're trying to get the dosimetry staff at

11 the sites more involved. It turns out if you ask

12 a records organization to provide records they'll

13 give you exactly what you ask for, but if you ask

14 a dosimetry person to help and assist in the

15 process, they tend to know. I've talked to

16 several people, and a light bulb goes off, and,

17 oh, if I was doing a dose reconstruction, what

18 would I use? Well, they can coordinate that

19 effort with the site personnel and hopefully get

20 a better product.

21 The second stage is the interview with the

22 claimant, and we are committed in the rule to

23 interview every claimant individually to help --

24 to add to their dose reconstruction effort, to

25 fill in missing information, to do consistency
61 

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1 checking on the information we receive from the

2 Department of Energy, that sort of thing. 

3 That is going to be performed through a

4 computer-assisted telephone interview concept --

5 that is, there's a computer program, there's a

6 script that we have prepared already that has

7 been approved by OMB. There are three flavors of

8 that. There is the claimant himself, there is a

9 survivor of a claimant, and then there is a

10 script for a co-worker. We're in the process of

11 computerizing that at the moment, and hopefully

12 we'll have the first draft of that finished this

13 week. It's in the process. Right now it's being

14 programmed in an Access format. Eventually we’ll

15 migrate that over to a SQL server program that

16 will be more compatible with our long-range

17 goals.

18 We have done one interview only so far, and

19 that was done by hand. We hope not to do that

20 again. That's a fairly labor-intensive process.

21 Evaluation of completeness and adequacy of

22 the information, we've done an initial review of

23 a number of cases that have been sent to us. And

24 I mentioned that we are cooperating with the

25 contractor sites providing the information and
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1 have given feedback to several sites regarding

2 what we really need, and that is we need to have

3 the individual monitoring data. We cannot have

4 summary information. That doesn't provide us any

5 useful -- it's somewhat useful, but doesn't tell

6 the whole story as far as the missed dose goes

7 and that sort of thing. So we're doing that.

8 As far as the atomic weapons employers go,

9 there appears at this point not to be any real

10 personnel data available at the atomic weapons

11 employers. There's a lot of information

12 regarding the source term that was there,

13 licenses that the AWEs possess, that sort of

14 thing, that we can sort of reconstruct a

15 plausible exposure scenario. But personnel

16 monitoring data is not there. 

17 We are doing a data capture effort next

18 week. A NIOSH team will be in Germantown, and we

19 will be electronically capturing on CD-ROMs all

20 the atomic weapons employer information that

21 exists in the Germantown files at this time. And

22 then we intend to go back and further go through

23 some of the files to add to these things as we

24 progress.

25 Calculation of dose to the organ once we
63 

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1 evaluate the completeness and adequacy of the

2 data. I did mention last week, we have the IMBA

3 program available, Integrated Modules for

4 Bioassay Analysis. That is a stand-alone program

5 right now that we can use to perform internal

6 dose reconstructions. However, we are in the

7 process of working with a contractor to update

8 that program to add some features that are

9 desirable. I think I mentioned that this week.

10 And report dose reconstruction results, we

11 haven't done any official dose reconstructions as

12 of yet, but we're in the process at this point of

13 crafting what the report will look like. We

14 intend to have a standardized reporting format

15 that includes certain key aspects of the

16 information that we'd like to report, that sort

17 of thing. So we're working on putting that

18 together.

19 I mention program documentation on this

20 slide because I think it's an extremely important

21 aspect of this program. We take this very

22 seriously. We want to have some sort of pedigree

23 for down the line when cases become challenged or

24 questioned or whatever, that we can actually go

25 to a file and point to the individual procedure,
64 

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1 implementation guide or whatever that was used at

2 that time to perform a dose reconstruction.

3 In my mind there's four major parts of this

4 documentation, and that starts with the case

5 file. And all the case files that have come into

6 our site so far have been electronically imaged.

7 We're working with PDF files essentially, Acrobat

8 type files. I think we've scanned well over

9 100,000 pages of information so far into our

10 system. It's a nice system. We can tab the

11 individual files with markers, that sort of

12 thing. And we hope that we won't -- actually,

13 the paper copies will be there for the record.

14 But when the contractor comes on board, when

15 NIOSH staff work with these things, they'll be

16 available directly on your computer screen, as

17 they are now for our OCAS staff. It's a very

18 nice way of doing business.

19 The implementation guides, which we're here

20 to talk about in more detail later, are sort of

21 the guts of our dose reconstruction process. And

22 I think everyone on the Board should have a copy

23 of that by now. It is a draft, so please feel

24 free to provide comments. And as I mentioned,

25 Tim and Dave will address those later on.
65 

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1 I will say that we tried to craft them so

2 that they were much more specific than the rule,

3 but at the same time one cannot envision -- I

4 learned this early on in OCAS, is you cannot

5 envision all eventualities that are going to

6 happen. Surprises happen daily as to what type

7 of dose, what type of exposure a person had, how

8 it occurred, when it occurred, those sort of

9 things.

10 So the guides will provide a general

11 framework for how this is going to work, but

12 we're going to -- we have a plan to have these

13 little technical basis documents, which are sort

14 of interpretation documents that are specific for

15 cases that are unique, something that you

16 wouldn't want to cover every aspect in an

17 implementation guide. But if we're presented

18 with a situation that is extremely unusual, maybe

19 cover a few types of cases, we'll cover that with

20 a technical basis document.

21 And then we also intend to have the standard

22 operating procedures that are even more specific

23 in certain areas about how we do business. Right

24 now we're talking about having -- we have a

25 procedure draft that's in place that essentially
66 

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1 covers all the steps that are in the rule.

2 Everything we said we would do in the rule, it

3 kind of goes through step by step and ensures

4 that we've covered everything that we committed

5 to doing.

6 I'd like to shift gears a little bit now and

7 talk about the dose processing strategy. As I

8 mentioned, I think it's the heart of our system,

9 and I talked about this last week, or last time

10 we met. The low-dose processing strategy --

11 there's two strategies that we can do with the

12 bracketing at the ends of the spectrum, if you

13 will.

14 One is the low dose, where a person presents

15 with a fairly low exposure profile from their

16 work history, someone in the low, below ten rem

17 for sure range. We would start conservatively

18 using their monitoring data and perform an

19 initial evaluation using worst case assumptions.

20 A good example of that is a person who was

21 exposed external only, an administrative

22 personnel who may have visited the controlled

23 areas of the sites on an infrequent basis, had no

24 internal dose. 

25 We could take and add into their record all
67 

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1 the missed dose from their external badge

2 results. I mentioned before if someone wore a

3 badge and there's a 30 millirem detection limit,

4 we could assign them a flat-out 30 millirem per

5 badge exchange, total up those doses, and

6 evaluate the probability of causation. And if

7 that probability of causation is extremely low,

8 then the dose reconstruction doesn't need to

9 progress any further. We've definitively -- we

10 bend it on the low side in an unbiased manner.

11 I've got some examples later of this that will

12 tie this together, I think.

13 Conversely, on the high-dose processing

14 strategy, it's the same thing except on the other

15 end, obviously. We could take an internal dose

16 case and only look at a piece of it. And if that

17 piece of the internal dose, those few bioassay

18 samples, results in a fairly large dose -- say,

19 for instance, to the lung from an internal

20 exposure event -- and just that one piece is

21 sufficient to create a probability of causation

22 that is well over the 50 percent limit, there's

23 no need for us to go through and calculate the

24 dose from each of those individual other bioassay

25 samples that are in a person's file. 
68 

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1 If it's not, we need to go in a more

2 detailed fashion, and I think the next slide kind

3 of covers this. This was presented last time,

4 but the basic concept here is determine the organ

5 of interest and the possible mode of exposure.

6 And so in this case, if a person is, let's say,

7 for example, working with plutonium that has a

8 fairly low gamma component to it, one could

9 calculate their plutonium exposure. 

10 If that probability of causation was

11 extremely low, we would go over to this branch

12 and look at the external component. We already

13 have judged that the external component may be

14 low, but we need to look at it, use some worst15 case assumptions there, adding in missed dose.

16 If that's also low, then we're complete. There's

17 no sense in continuing on.

18 On the other hand, if the probability is not

19 low but high, we take those few points and the

20 person's well over the 50th percentile based on

21 our evaluation, then we'll ratchet it down a

22 little further, tighten it up, take a

23 conservatively low estimate. If the

24 probability's still high, then the dose

25 reconstruction's complete.
69 

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1 So the idea is to work over to this complete

2 phase. However, there are going to be cases,

3 those in the middle, that will fall all the way

4 down through the bottom. And then we have to

5 take -- even after looking at both conservatively

6 low estimates, if the dose reconstruction is

7 still indeterminate, it's still unknown, then

8 it'll drop down here, and then we'll have to end

9 up doing a very complete analysis of the whole

10 case.

11 This is an example I talked about with an

12 external exposure case. If you look over on this

13 column there’s a gamma exposure for the

14 individual, sums to about -- what is it -- 270

15 millirem actually on their badge results between

16 1954 and '61. And over here we've included the

17 missed dose, and the missed dose adds up to

18 somewhere in the vicinity -- I think it's 350

19 millirem if you total this column. This column

20 is a factor of five higher in dose than what was

21 reported by the actual badge results that we

22 received from the Department of Energy, so we've

23 increased their dose by a factor of five.

24 But if you look at this next example --

25 let's just say, for instance, this person
70 

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1 presented with prostate cancer. Even with all

2 the missed dose added in it's 1,350 millirem --

3 and this is just a graph of the probability of

4 causation of prostate cancer as a function of

5 total dose delivered -- and one can see that at

6 the 50th percentile, even for a fairly early age

7 at diagnosis at 40 years, the dose is somewhere

8 in the 30 rem range. So in this particular case

9 we would make a fairly -- it would be fairly easy

10 to conclude that if the Department of Labor were

11 to run this calculation using the IREP program,

12 the person would not be qualified for

13 compensation.

14 These graphs are sort of interesting. One

15 can see the effect of the age at diagnosis on the

16 probability of causation. There are a number of

17 factors, of course, in IREP that drive these

18 different curves. One is the age at diagnosis,

19 which I believe is related to just the increase

20 in the background incidence rate as you get

21 older, so the chance that your cancer was caused

22 by the radiation is diminished by the fact that

23 the background incidence is higher. So one can

24 see that these values are fairly well above the

25 one and a half rem range.
71 

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1 This is also going to be the case for

2 someone, for example, who was exposed internally

3 to something like plutonium, that only

4 concentrates selectively in essentially three

5 organs -- four if you count the gonads -- the

6 lung, liver and skeleton. So we could do a very

7 worst case assumption of what their inhalation

8 intake to plutonium may have been. The prostate

9 gland is very -- not very -- not irradiated

10 significantly at all from that exposure. So

11 again, their dose would be down into this range.

12 If you take a look at lung cancer, however,

13 on the other extreme end, here's a case where if

14 a person had -- again, I hate to keep using

15 plutonium, but it's a good example -- if a person

16 had inhaled plutonium and received a fairly large

17 intake that would result in a lung dose, and it

18 would not be inconceivable that person could have

19 inhaled enough plutonium to be in this 20 rem

20 range. 

21 Remember, these values are equivalent doses,

22 not effective doses, so these are not multiplied

23 times the .12 for the weighting factor. So a

24 five rem annual dose limit, a person could easily

25 receive in the 20 to 25 rem range. 
72 

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1 So for a non-smoker at the 50th percentile,

2 it's somewhere -- I can't see it very well from

3 here -- but 25 to 30 rem. So if we took that one

4 case where a person had one intake that was

5 fairly large, we estimate it was well over 25 to

6 30 rem, that person would be judged -- his dose

7 reconstruction would be complete, and it would be

8 forwarded on.

9 I show these graphs just to give a sense

10 we're working towards developing these tools for

11 our dose reconstruction people, so that we don't

12 -- we're not in the business of running the

13 probability of causation calculations, but we

14 need to develop these kind of tools that the dose

15 reconstruction people can use to do this

16 efficiency process, the bracketing at the extreme

17 ends.

18 I think the next slide is just an example of

19 the different probability of causations for

20 different cancers. This is for leukemia. The

21 solid cancers you can see were, in those examples

22 that I showed, were in the tens of rem range at

23 the 50th percentile. Leukemia, this is sort of

24 an optimum condition here: five-year latency

25 period, and a person is -- at 20 years old, you
73 

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1 can see it takes very small, much smaller amount

2 of exposure, in the one to two rem range, for a

3 person to qualify for compensation from leukemia.

4

5 So someone with an exposure profile in the

6 past that had a large missed dose component from

7 the external badge, in particular if they

8 developed leukemia at a fairly early age, it

9 would be pretty simple to determine if someone

10 had a missed dose that was in the three to ten

11 rem range, that the probability of causation

12 calculation, if run, would qualify that person

13 for compensation.

14 I'd like to switch over to talk a little bit

15 about radon. I mentioned before that radon is

16 unique in this program in the sense that there is

17 no -- there are no bioassay methods available for

18 radon. You can't take a urine sample or a lung

19 count or whatever, so we're going to basically be

20 doing exposure reconstructions. 

21 The reason that we do the exposure

22 reconstruction is because that's what the PC

23 calculation is based on, cumulative working level

24 month exposure to the worker. And it's

25 essentially an adaptation of the risk model
74 

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1 developed by Jay Lubin, et al., at the National

2 Cancer Institute, which is based on the risk

3 values from the U.S. uranium miner studies.

4 An interesting feature of radon is one does

5 need to look at natural background. We're

6 looking at how we're going to deal with that.

7 One has to distinguish at some point the

8 difference between natural radon and DOE's radon.

9 There are fluctuations about the country. It may

10 be that if we can do the efficiency process

11 where, even including natural background and the

12 radon exposure, that the person is not going to

13 fall in a compensable region, it's okay, we don't

14 need to worry about that. 

15 But it's been my experience that radon does

16 fluctuate quite a bit in the work place, and

17 we're going to have to develop some method to

18 deal with that. Fortunately, there are not that

19 many sites where radon is going to be an issue.

20 The well-known ones are the Fernald site,

21 Mallinckrodt. I used to run the dosimetry

22 program at Argonne National Laboratory. There

23 was a few areas that were contaminated back in

24 the early days that maybe there's some elevated

25 levels, but not that many. Actually, the
75 

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1 original site in New York where the residues went

2 from New York to Fernald, the K-65 material,

3 probably we need to look at.

4 But we do intend to include this. The way

5 the probability of causation calculation will

6 work is it will treat those independently. You

7 can have an exposure -- concomitant exposure to

8 external exposure and radon and run the program

9 through, and it will actually sum the two risk

10 values for you.

11 Unfortunately, monitoring records are

12 probably going to be fairly poor. Having looked

13 at the records at several of the sites that do

14 have radon issues, the monitoring records are

15 fairly poor. Very rarely were working levels

16 actually measured. Air concentrations were

17 taken, then one has to do some basic assumptions

18 about the percent equilibrium of the radon, that

19 sort of thing. So it's going to be a tricky

20 exposure reconstruction.

21 And my final slide, I just want to touch

22 base a little bit about atomic weapons employers.

23 They are somewhat unique in the sense that the

24 period of covered employment -- it's fairly

25 obvious for a DOE facility that the entire time
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1 the facility was in operation is covered. An

2 atomic weapons employer, there is a covered

3 period where a person is eligible to be in the

4 program, but the covered exposure actually

5 extends beyond that. So we're in the position of

6 having to reconstruct records that go well beyond

7 the period of time at which the DOE was involved

8 in that operation. That's going to be a

9 difficult issue for us. We're working on that

10 right now.

11 Part of that is this residual contamination

12 study we have in place that was enacted recently

13 in an amendment to the Defense Authorization Act.

14 NIOSH was charged with doing a residual

15 contamination study at the atomic weapons

16 employers facilities to determine if the covered

17 employment period should be extended based on

18 contamination at the site that was left there

19 after DOE operations ceased. And so in looking

20 at that, I think what's going to give us a fairly

21 -- much better handle on what the exposure looked

22 like in those time periods after the workers no

23 longer -- after the DOE work was completed.

24 I touched on earlier about the availability

25 of personnel monitoring data. It's going to be
77 

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1 interesting. I don't know that many of them

2 actually -- atomic weapons employers actually

3 collected personnel monitoring data, so we may

4 have to rely more on source term analysis for

5 these particular employees than the DOE cohort.

6 One possibility does exist, though. We've

7 looked at a couple of these facilities that a

8 number of them on the list did not appear to do

9 very extensive processing of materials. A large

10 percentage of the atomic weapons employers are

11 uranium -- handled uranium as a result of --

12 Fernald site seems to be responsible for quite a

13 few of those. They were a manufacturing

14 facility, essentially a metals foundry, so they

15 would farm out certain pieces to try a new

16 rolling mill processor or whatnot. And in doing

17 that, it looks like there are some instances

18 where the facility itself did not handle fairly

19 large amounts of dispersible material; it was

20 solid metals. 

21 So it may be that we can, again using an

22 efficiency process, look at some of these

23 facilities and determine that the dose is below a

24 certain level that would not result in

25 compensation for any of the employees in that
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1 facility, and allow us to do that, evaluate that

2 in a white paper, a technical basis document,

3 publish it on our web site so people could review

4 our logic, and move forward without having to do

5 an individual dose reconstruction for anyone at

6 that particular facility. Anyway, that's the

7 concept on that at this point.

8 That concludes my formal remarks this

9 morning. If there are any questions, I'd be more

10 than happy to address them.

11 DR. ZIEMER: Thank you very much, Jim. 

12 Keep in mind that we will be hearing a lot

13 of detail on both external and internal dose

14 reconstruction from our following speakers, Tim

15 Taulbee and Dave Allen. So this presentation by

16 Jim Neton has given us kind of an overview of

17 dose reconstruction, but let us take at least

18 early questions here.

19 Yes, Henry Anderson.

20 DR. ANDERSON: Are you setting this up so

21 you can put this data into an analytic database?

22 It would seem to me that as you gain experience

23 here you may find -- for instance, as you showed

24 with the leukemia -- that some specific diseases

25 or places will fall into then the special group. 
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1 So it would seem to me that based on looking

2 at this, you may be able to look at -- identify

3 classes of people that have come through, that

4 then you wouldn't have to run them through

5 because you'd always be confident, and therefore

6 they'd be moved into a -- this would be, rather

7 than being -- people having to petition, you

8 would have the actual data to show that of all of

9 the claims from this facility for this disease

10 coming through, they've all been well over your

11 threshold, and therefore it would make sense that

12 they would then move into the special category.

13 DR. NETON: Yeah, that's correct. We do

14 plan on doing that, to have essentially an

15 exposure matrix --

16 DR. ANDERSON: Yes.

17 DR. NETON: -- if you will, for certain

18 classes of workers, whether it's a chemical

19 operator at a certain facility, a uranium

20 facility, take advantage of this as we learn from

21 our dose reconstruction process.

22 DR. ZIEMER: Jim.

23 DR. MELIUS: Who is going to be doing the

24 interviews with the claimants?

25 DR. NETON: Well, NIOSH staff will initially,
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1 since we don't have the dose reconstruction

2 contractor in place. But once the contractor is

3 in place, they will be doing the interviews.

4 There are certain -- the RFC, Request for

5 Contract, stipulates certain qualifications for a

6 person to be a qualified dose -- do an interview.

7 DR. MELIUS: Okay.

8 DR. NETON: Certain level of knowledge of

9 DOE facilities, certain educational background,

10 certain number of years’ experience.

11 DR. MELIUS: And is the interview script

12 available? I haven't looked at the web -- is

13 that on the web site now, or is that --

14 DR. NETON: It's not on the web site

15 currently. I don't know that it couldn't be.

16 Larry might address that.

17 MR. ELLIOTT: It's not on -- the interview

18 questions and the script is not on the web site.

19 We have an emergency approval from OMB for --

20 under the Paperwork Reduction Act for that

21 script, and we're currently trying to -- we have

22 an application in for a permanent -- or an

23 approval of that script. We can put it up. We

24 can load it up on the site if --

25 DR. MELIUS: And could we also get a copy to
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1 the Board?

2 MR. ELLIOTT: Sure, we'll do that. We'll do

3 that.

4 I would also like to comment on Jim's

5 comments on the AWEs. We do know that some AWEs

6 did have radiation monitoring data, like

7 Mallinckrodt, and we have a lot of that already

8 in our hands. But by and large, we're still

9 pursuing whether or not some of these AWE sites

10 have any, if at all --

11 DR. NETON: Right.

12 MR. ELLIOTT: -- personal dose information.

13 DR. NETON: There are over 300 AWEs, and

14 it's very hard to track -- some of them aren't in

15 business anymore, have been out of business for a

16 long time. In some cases the facility is no

17 longer even there. So we will be pursuing that

18 with some vigor in the next couple months.

19 MR. ELLIOTT: Also, the computer-assisted

20 telephone interview, when we have the contract in

21 place, those interviews will be done in the NIOSH

22 facility. The contractor will live with us doing

23 that.

24 DR. NETON: That's a good point. The

25 contractor's required -- we will provide them
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1 space to do the interviews at a NIOSH facility,

2 primarily so we can actually get a handle on how

3 they're going and monitor the quality of what was

4 going on, since it's a very big piece of this

5 assessment.

6 DR. MELIUS: Again, refresh my memory. I

7 think I asked this last time also. But what

8 information will be given to the claimant prior

9 to the interview?

10 DR. NETON: They will be provided -- not

11 necessarily the entire script, but some

12 information as to what lines of inquiry we're

13 going to be going through in the interview. The

14 script right now, as I said, it sort of looks

15 like a fill-in-the-blank kind of thing. We could

16 use that, but I think we could cut it down a

17 little bit so that it wasn't as long and give

18 them the same information. But all the

19 information that we'll be discussing will be

20 provided to them prior to their interview

21 occurring.

22 DR. MELIUS: What about the exposure

23 information that's been received from DOE? Will

24 they be provided with that ahead of --

25 MR. ELLIOTT: We talk to them about that
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1 over the phone during the interview process, and

2 we can make it available to them if they request

3 it. It's been our thinking that we wouldn't

4 automatically provide that because it might

5 prompt confusion with what they typically get as

6 reported cumulative annual dose from DOE. 

7 So as we go through the interview process

8 we'll walk them through all the information we

9 have collected from DOE, what we have in our own

10 hands at NIOSH, and will explain the process of

11 going forward with evaluating that information

12 and how their interview questions will aid us in

13 doing dose reconstruction. So there's a highly

14 interactive process we envision dealing with the

15 claimant through the interview.

16 DR. NETON: In preparation for the

17 interview, the person that is conducting the

18 interview will go through the entire file,

19 including the DOE dose records that are

20 available, and use that to query in some depth,

21 customize it in some ways to the individual

22 claimant. 

23 And we'll be looking for things like

24 consistency. If a person says they wore a badge

25 all the time and we received a report from the
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1 Department of Energy that they have no monitoring

2 information at all, that's going to take us down

3 a different path. Or if a person was involved in

4 a number of incidents and we have those incident

5 reports, it'll be interesting to compare notes as

6 to what the claimant states versus what's in the

7 official record, that sort of thing.

8 DR. MELIUS: Yeah, but I guess my concern

9 would be there's -- if you do it the way you

10 described it, I think that's good. If you did it

11 the way, well, I have your records from '55 to

12 '65, we have all your exposure records so we

13 don't need to talk about that, or -- and they

14 just say okay without knowing what's there, or

15 especially with someone with sort of a

16 complicated work history, that could be

17 problematic.

18 DR. NETON: This is going to require some

19 level of expertise on the interviewer to do a

20 good job. We've already recognized certain

21 instances -- if you ask a person did you ever

22 wear a badge, a monitoring badge, or were you

23 ever assigned a badge, and they say, well, no;

24 but in pursuing the conversation we find out

25 that, well, they were not assigned a badge, but
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1 they visited areas that required a badge and were

2 issued temporary badges every month. So we would

3 have never known that if a person didn't have

4 good interview techniques. So it's going to

5 require some skill.

6 MR. ELLIOTT: The intent of our interaction

7 through this interview is to elicit information

8 from the claimant that might aid us in going back

9 to DOE seeking additional information that might

10 not have been forthcoming. And we're not only

11 hoping to get that, but if there's situations

12 that no DOE record would support, we're asking

13 the claimant through the interview process to

14 identify co-workers that can verify or validate

15 your claim, this aspect of your claim, and we'll

16 get an affidavit from that individual.

17 DR. MELIUS: A related question, and I think

18 it's sort of the same issue, approaching it from

19 a different -- tell me if you're going to present

20 this later, because I haven't gone through all

21 your slides yet. But how are you going to judge

22 the completeness of the data that you're

23 receiving from the DOE and/or the facility? 

24 You've got a number in the draft regulation,

25 you list a number of items you'll look at. But
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1 that's a wide range, and it's a lot of

2 information. And how are you going to sort of

3 collectively build up your knowledge base that

4 you can judge what's complete? You want an

5 efficient process. At the same time you also

6 want to make sure that you're getting as much

7 information as is there and is relevant to the

8 person's case.

9 DR. NETON: That's a real good question. In

10 the beginning the process is not going to be as

11 efficient as we'd like, because we're requesting

12 these individual cases, we're getting a file. We

13 don't really have a sense that we've got

14 everything that may be available to us. 

15 So we've envisioned early on is to have a

16 parallel process in place where we will actually

17 be collecting the DOE's records themselves and

18 bring them in to NIOSH, putting them on our own

19 computer system, developing that database, so

20 we'll have a sense as to what information the DOE

21 really has available, such as the work place

22 monitoring information, air sampling data, that

23 sort of stuff. But we need to get onto the DOE

24 sites, get there, talk to the people that have

25 these records, and determine if this information
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1 is actually even available in a reasonable time

2 frame, because time is a critical issue.

3 DR. MELIUS: But how will you -- will that

4 also include going out and getting the

5 information from the contractors as opposed to

6 what DOE has collected? My experience has been

7 that the DOE offices don't always have as

8 complete information as the contractor will.

9 DR. NETON: That's correct. And in reality,

10 most of the information's coming from the

11 contractors already. The Department of Energy

12 really doesn't have a repository per se of all

13 the information we need. We are working through

14 the operations offices, the DOE operations

15 offices. But then once they forward that to the

16 contractor, we're interacting with them directly.

17 Once the packet has been forwarded to, say, the

18 Savannah River site or Hanford or whatever, we're

19 in communication with the contractor. And that

20 would include visits to the contractor's site.

21 MR. PRESLEY: Bob Presley. 

22 One of the things that I think you need to

23 ask, make sure that you get multiple sites. A

24 lot of the people, maybe they worked at one site,

25 but they visited other sites during their work
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1 experience where they would have gotten a

2 contamination dosage at some other site.

3 DR. NETON: Was the question how are we

4 going to deal with that issue?

5 MR. PRESLEY: Yes. Are you doing to deal

6 with that issue?

7 DR. NETON: Oh, absolutely. We intend to

8 deal with that. And a lot of that is going to be

9 either based on the record that is in the

10 person's file -- DOE has kept track of that to a

11 certain extent, but not perfect, I might say --

12 but also this is where the interview process

13 comes in. If a person can inform us as to where

14 they went, what they did and how often, what time

15 period, we'll pursue that at that other site. So

16 we certainly have to include that in the record.

17 DR. ANDERSON: Going back to the previous

18 presentation, it seems to me the only time you'll

19 move to interviewing somebody is if you have not

20 -- if the records you've already received would

21 not qualify them for a sufficient exposure. 

22 So really what you're doing -- it'll be

23 important. If that's the case, then it would

24 seem to me sharing what you already have with the

25 worker so they can see the completeness of it
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1 would be very important, because unless you

2 interview everybody the reality is those people

3 who have qualified you would already have short4 circuited out of the system; those who are very

5 low would be out; and these are the only ones

6 that you're still building their dose, and you're

7 looking for other exposures that may not have

8 been in your base information.

9 DR. ZIEMER: Larry has a response.

10 MR. ELLIOTT: Dr. Anderson, we will be

11 interviewing everybody, okay. And the level of

12 detail we get into the interview will depend upon

13 the complexity of the work history, how many

14 sites they worked at, how many different

15 radionuclides they might have been exposed to.

16 So everybody will get an interview. Everybody

17 will be able to contribute to their case file

18 through that interview.

19 DR. ANDERSON: Because I thought in the

20 previous, it looked like it was a step-wise, that

21 if through kind of an administrative review the

22 person would qualify for compensation, you would

23 move them into that range rather than go through

24 further interviews and whatever. If you're going

25 to interview everybody, then that's a different
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1 scenario.

2 MR. ELLIOTT: To achieve the efficiency

3 process --

4 DR. ANDERSON: Yeah.

5 MR. ELLIOTT: -- we have that intent in

6 mind, to try to categorize the claims as they

7 come forward. Those that are obviously high

8 enough that they're going to get an award, but

9 they'll still get an interview. Those that are

10 obviously low enough that they're not going to

11 achieve an award through the final adjudication

12 will still have an interview, and we'll use that

13 information to make sure that -- again, we're

14 trying to achieve an accurate estimate of dose

15 here as much as possible.

16 DR. ANDERSON: Okay.

17 DR. NETON: There may be something that

18 comes up in the interview, if a person appears to

19 be qualified on face value, that might be helpful

20 for someone else's case.

21 DR. ZIEMER: Sally.

22 MS. GADOLA: I have a question that goes

23 along those lines. 

24 Suppose you get someone, after all the

25 radiation dose reconstruction is done, it looks
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1 as if their cancer was not caused by radiation.

2 However, it might very well have been caused by

3 other chemicals that they worked with in that

4 environment. Is anyone going to be advising

5 them, because then they would want to apply to

6 the state worker's comp?

7 MR. ELLIOTT: That comes back to the

8 Department of Labor's responsibility at the point

9 of adjudicating the claim. And when our dose

10 reconstruction report goes forward to DOL and to

11 the claimant, and DOL uses that information from

12 the dose reconstruction report in the probability

13 of causation in the IREP and they find that

14 they're below the 50 percent mark and their

15 recommended decision is not to award, then I

16 assume that the Labor Department and DOE will,

17 through their outreach program and their worker

18 advocacy program, encourage the claimant to

19 pursue the Subtitle D aspect of the program,

20 which is through the state worker's comp program

21 through the physician panels that DOE sets up.

22 And any dose reconstruction that we have done on

23 radiation would just travel along with that case

24 file for that individual.

25 We do not, though, in our program here on
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1 doing dose reconstruction for cancer-related

2 claims, we are restricted to radiation exposure.

3 We are not including chemical exposures.

4 MS. GADOLA: I understand that, but I'm just

5 concerned with the workers, and especially the

6 survivors, who would not even know what type of

7 questions to ask, because they would not know

8 what their family members might have worked with.

9 Thank you.

10 DR. ZIEMER: Other questions or comments?

11 Jim.

12 DR. MELIUS: Are you allowed to do more than

13 one interview under your OMB approval?

14 DR. NETON: Yes, nothing precludes us from

15 doing more than one.

16 DR. MELIUS: Okay, good.

17 DR. ZIEMER: Whatever it takes, probably.

18 DR. MELIUS: Yes, I could see it being a

19 step-wise process with certainly some claimants,

20 where they tell you something that wasn't in the

21 records you've got. You go back, get that

22 information you need to then ask them further

23 questions, and --

24 DR. NETON: In fact, with survivors that

25 would probably be routine. We will obtain names
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1 of co-workers, just for the reason the person

2 will say, well, I don't know what my husband or

3 wife did at the site. It was classified. And so

4 we'll try to obtain names of co-workers who still

5 may be alive and work it through that way.

6 MR. ELLIOTT: The interaction with the

7 claimant through the interview instruments that

8 we've designed, we envision it to be very

9 dynamic. It's going to have to be malleable to

10 the situation. 

11 We've envisioned it that we're going to have

12 to not do some of these by telephone. We're

13 actually going to have to do some of these

14 interviews face to face. We're going to have to

15 do some of these interviews with a Q-cleared

16 interviewer in an environment where the

17 discussion cannot be overheard. We're going to

18 have to do some of these interviews with

19 assistance to the claimant who perhaps cannot

20 hear, cannot speak.

21 We're going to have to do some of these

22 interviews where we give advance time and

23 opportunity for the claimant to go through the

24 questionnaire and prepare themselves because --

25 and we're going to have to fractionate some of
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1 these interviews so that we don't consume an

2 individual's energy in the interview process, and

3 we have to go back to them and finish it up maybe

4 two or three, in two or three sessions. 

5 So we've envisioned this to be a very

6 dynamic interaction that is situation-dependent.

7 DR. ZIEMER: Which means that it will also

8 be a time-intensive process, clearly, yes.

9 Other questions or comments?

10 (No response)

11 DR. ZIEMER: Okay, thank you very much, Jim.

12 Appreciate that overview, and the questions were

13 very helpful as well.

14 I'd like to proceed to the presentation on

15 external dose reconstruction guidelines. Tim

16 Taulbee of NIOSH is with us today. This item on

17 the agenda was originally scheduled for this

18 afternoon, but we do have, I think, time now for

19 both the presentation and the questions. 

20 And Jim (sic), in connection with your

21 presentation, you're talking about the draft

22 internal (sic) dose reconstruction guideline, I

23 believe, that was distributed to the Board

24 members in advance. Is that correct?

25 MR. TAULBEE: I'll be talking about the
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1 external --

2 DR. ZIEMER: Yes, I said -- and I said

3 internal. I grabbed the wrong one. I meant --

4 everybody knew I meant external, right? Right.

5 So Tim, please.

6 MR. TAULBEE: Thank you, Dr. Ziemer. 

7 I'd like to thank the Board for this

8 opportunity to talk to you about external dose

9 reconstruction as we currently envision it. And

10 this is a draft. This is our approach as it is

11 now, and we're eager to hear your thoughts and

12 comments on this.

13 What I'd like to do is to try and take you

14 through a dose reconstruction from us receiving

15 data from the Department of Energy, dosimetry

16 data, and how we would compile all of this and

17 get to the inputs that -- the data that we would

18 enter into the IREP program. So that's kind of

19 the approach that I would like to take today in

20 discussing the external dose reconstruction

21 process.

22 Basically there are two types of dose

23 reconstruction: One where have personal

24 monitoring data, which is for the vast majority

25 of the claimants. These are people that worked
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1 at Department of Energy sites. And then the

2 other type of dose reconstruction would be where

3 we don't have personal monitoring data, where

4 we'd use co-worker data or survey data, source

5 term data and possibly even radiological control

6 limits.

7 From the guideline that was given to you

8 prior to the meeting here, the personal

9 monitoring data is section two; the no personal

10 monitoring data would be section three. What I'm

11 going to focus on today is when we have personal

12 monitoring data. Like I said, this is going to

13 be the typical process going through, where

14 somebody worked at a Department of Energy site

15 and they were monitored with film badges or

16 thermoluminescent dosimeters.

17 DR. DeHART: Could I ask whether or not we

18 can interrupt for questions as we go along,

19 because there's going to be definitions going

20 through here and it's going to get technical.

21 DR. ZIEMER: Do you have any objection to

22 taking questions as they arise?

23 MR. TAULBEE: No objection whatsoever.

24 DR. ZIEMER: Let's do that, then.

25 DR. DeHART: I have one question -- I think
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1 I know the answer -- but source term is a term

2 that I'm not really familiar with. I assume that

3 would be an isotope or something of that sort?

4 MR. TAULBEE: That's correct. The source

5 term information would be that at a particular

6 uranium machining facility, we know the quantity

7 of material, of uranium that was sent to them for

8 processing, and we know basically what they were

9 doing. They were milling it or they were

10 machining it. And so from the dimensions of what

11 they were starting with, we can estimate what

12 their external dose is based upon the quantity of

13 radioactive material. 

14 So I guess the primary thing I'm going to

15 focus on is where we have personal monitoring

16 data. And so there are four basic components or

17 elements to the dose reconstruction, and the

18 first one is discussing the different components

19 of external dose; and then the conversion of that

20 external dose to an organ dose for the

21 probability of causation; and then defining the

22 uncertainty and determining the distribution

23 surrounding this external dose that we come up

24 with; and then the actual interface into the IREP

25 program.
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1 With external dose -- and you've seen some

2 of these slides before that Jim had briefly gone

3 over in his previous presentation here; please

4 pardon me repeating some of them as I go into

5 more detail -- but there's four basic components.

6 There's the measured dosimeter dose, where a

7 person wore a film badge or a TLD at the site.

8 There's what we call the missed dose, or what the

9 dosimeter couldn't read due to a limit of

10 detection and a combination of the badge exchange

11 frequency. And then there's the occupational

12 environmental dose. This would be primarily from

13 stack emissions and from other ambient sources

14 around in the work environment. And then their

15 occupationally derived medical dose. And the sum

16 of these is what we consider the total dose to

17 the individual.

18 We're starting with the dosimeter dose.

19 This is a simple summation of all of the

20 dosimeter readings that we got from the site

21 where you add them up. And the uncertainty --

22 each dosimeter reading will have an associated

23 uncertainty with them. And you combine them by

24 summing the variances, and the standard deviation

25 is calculated by the square root of the sum of
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1 the variances.

2 To give an example for this, this would be

3 an individual in Hanford facility at 1951, and

4 these were all of their non-zero badge readings

5 for that particular facility or for this

6 particular year of exposure. And what I'd like

7 to point out here is this is 12 readings. Well,

8 the individual actually had 39 dosimeter readings

9 over the course of this particular year. These

10 are the 12 that were non-zero, so this is what

11 we're considering the dosimeter dose, the actual

12 dose that was measured. And the sum of them

13 comes out to 415 millirem with a standard

14 deviation of 49 millirem.

15 DR. ZIEMER: Let me interrupt at this point

16 and ask kind of a practical question. 

17 Clearly in 1951 the rem unit didn't exist,

18 so their numbers would be in some other unit,

19 maybe rep, maybe -- I guess if you go back, even

20 some of the facilities were using what they

21 called a sunshine unit, and I don't even remember

22 what that is anymore. But the numbers that you

23 get, you're not assuming these are millirem to

24 start with, so you're --

25 MR. TAULBEE: No, that is correct.
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1 DR. ZIEMER: -- this is a converted number

2 that you're showing us to start with. Is that

3 correct?

4 MR. TAULBEE: Actually, it's not. I

5 misspoke there, and I apologize for that.

6 DR. ZIEMER: Okay.

7 MR. TAULBEE: These are in milliroentgen at

8 this time. Later on you'll see that I'll go

9 through a conversion in which we will get to the

10 actual organ dose, which will then be in rem from

11 that standpoint.

12 DR. ZIEMER: Right. Because you're going to

13 have a hodgepodge of units for anything before --

14 MR. TAULBEE: Absolutely.

15 DR. ZIEMER: -- about the mid-fifties to the

16 late fifties.

17 MR. TAULBEE: That is correct, yes.

18 DR. ZIEMER: Okay.

19 MR. TAULBEE: I apologize there. And as you

20 see, the slide is incorrect there at the bottom.

21 This really is milliroentgen, mR. This is an

22 exposure for this particular example.

23 What we assume for the dosimeter dose is

24 that it's following a normal distribution in

25 which the mean was calculated as the average of
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1 this distribution, the 415 millirem (sic), and

2 then the uncertainty associated with it, two

3 standard deviations or 95th percent uncertainty,

4 it'd be 513 millirem -- milliroentgen.

5 So now the missed dose. Right now what I've

6 showed you so far is what we've actually measured

7 with a dosimeter on an individual. The missed

8 dose is what the dosimeter couldn't measure due

9 to a limit of detection and then the badge

10 exchange frequency. In earlier years the badge

11 exchange frequency at many facilities was weekly.

12 By modern standards it's in many cases quarterly.

13 And so there's a longer time period that dose can

14 be measured, and the limit of detection has also

15 decreased. 

16 So really missed dose is primarily important

17 in very early monitoring time periods. And the

18 root of the missed dose is really the number of

19 badges that have been recorded as a zero

20 measurement. And I mention that it's been

21 recorded as a zero measurement, not necessarily

22 that that's what they measured. At some

23 facilities they could measure lower. However,

24 they had administrative practices to where they

25 would not record below 30 mR, even though they
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1 could measure at a lower dose.

2 For the missed dose determination we're

3 assuming a lognormal distribution with -- and the

4 geometric mean would be calculated by the number

5 of zero dosimeters times the limit of detection

6 divided by two. This is kind of the central

7 estimate.

8 Yes?

9 DR. ROESSLER: I should have waited until

10 you got done with your sentence. 

11 You've already talked about two different

12 probability distributions, and we had some last

13 time. At some point will we get some discussion

14 on the rationale for choosing the different

15 distributions? Because they do look different,

16 and the outcome can be different, quite a bit

17 different, depending on which one is chosen. I'm

18 not asking for it right now, but I think that's

19 something that we need to have a little tutoring

20 on.

21 MR. TAULBEE: Certainly. The thought behind

22 the lognormal distribution for missed dose goes

23 back to looking at individuals' doses as a whole

24 over their entire work history. They tend to

25 follow a lognormal distribution. And that's why
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1 the component of missed dose we're assuming is a

2 lognormal at this time, because of that.

3 Underlying distribution of all of their data

4 should be lognormally distributed. 

5 The reason that we're using the normal

6 distribution for the dosimeter dose is because we

7 have a lot of individual measurements that have

8 an uncertainty about them, and we generally

9 believe that it's going to follow more of a

10 normal for a particular year. And that's kind of

11 the key across this, is making a transition in

12 there.

13 We could use a normal distribution; that's

14 possible for this particular scenario. My own

15 experience so far, from looking at a lot of this

16 data and below detection limit data and some of

17 the research that I've done in the past, is

18 indicating that it's more lognormal. 

19 Yes?

20 DR. NETON: I'd just like to add to that,

21 Dr. Roessler. 

22 I think the first -- the measured dose on

23 the dosimeters is really -- I think this is

24 correct -- is really just the instrument

25 detection -- the air on the instrument
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1 measurement itself, and that's typically normally

2 distributed in a laboratory environment. Every

3 time you measure something it's plus or minus a

4 certain percentage, essentially. I think that's

5 the main reason for the normal distribution for

6 the doses that are detected. And when you sum

7 them, you end up with just a broader normal

8 distribution.

9 On the missed dose determination, though --

10 Tim has demonstrated this in a paper he presented

11 at the Health Physics meeting last year -- that

12 missed doses typically are normally distributed,

13 and I think Straume and others have demonstrated

14 this as well. So there's some technical logic

15 behind it, but we'd be more than happy to

16 document that better as to the selection of those

17 doses. 

18 I think in the end result Tim will sum up

19 and show you how we ended up taking all these

20 different distributions and coming out with a

21 final product, which is I think where he's

22 heading.

23 MR. TAULBEE: Okay. And then to continue

24 on, the upper 95 percent, the number of

25 dosimeters times the limit of detection to get
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1 the upper bound of what we estimate the missed

2 dose to be.

3 To give an example, following along with the

4 previous individual, 39 weeks they were monitored

5 in a radiological area, or nine months. They had

6 12 positive readings, 27 zero readings, and the

7 limit of detection was 30 mR. And the geometric

8 mean, then, in going through the calculation,

9 would be 405 millirem with the upper 95 percent

10 bound at 810 mR. 

11 This would be the lognormal distribution

12 that will be -- all of these distributions, by

13 the way, will be coming back toward the end as we

14 begin to roll them all together, so I'm trying to

15 show how we create each one individually before I

16 sum them all together. And again, the geometric

17 mean in this general shape there with the missed

18 dose.

19 With the environmental dose -- and as Jim

20 had indicated in the previous presentation here,

21 and as I said earlier -- this is primarily from

22 stack emissions, from ambient environment. There

23 are certain locations at different facilities --

24 I believe you've seen a graph of the Hanford

25 facility where you can see the plume and how it
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1 moved in different areas -- and that's what we're

2 talking about with this environmental dose.

3 And how we calculated it is the number of

4 months that they were in the area, the average

5 monthly dose rate for that particular year of

6 interest, and then an occupancy factor. And the

7 reason we use an occupancy factor here is that

8 these average dose rate measurements were

9 primarily 24 hours a day, seven days a week, four

10 weeks out of the month, and the 12 months out of

11 the year. So they're a summation, but most

12 workers aren't at the facility that entire time.

13 From the interviews that we do -- at least

14 in the limited experience that we have now -- the

15 worker was able to identify certain time periods

16 where they were working overtime, where they were

17 working extended periods for a long -- seven days

18 a week for a period of five or six months. And

19 so that occupancy factor then can be adjusted to

20 account for that additional time, then, on-site.

21 DR. ZIEMER: Tim, I have a question on this.

22 This is on-site dose. It's submersion cloud,

23 submersion type of thing.

24 MR. TAULBEE: That’s correct.

25 DR. ZIEMER: Largely gamma then -- well,
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1 could be beta, but let's say gamma. 

2 Are you assuming that the badge did not pick

3 this up?

4 MR. TAULBEE: Yes. In many cases the badge

5 -- there was a control badge in the general area

6 of where the worker was that was then subtracted

7 out when the measurements were done.

8 DR. ZIEMER: So the control badge picked it

9 up and it was removed. I see.

10 MR. TAULBEE: That's correct.

11 DR. ZIEMER: Okay, thank you.

12 MR. TAULBEE: And so the calculation then

13 for the environmental dose would be the number of

14 months, the average dose rate and the occupancy

15 factor, 129 millirem for this particular year.

16 Again, we're assuming an environmental -- or a

17 lognormal dose distribution. Again, this comes

18 from experience of environmental doses.

19 Environmental measurements tend to follow more of

20 a lognormal type of a distribution, so the

21 geometric mean of 129 millirem in the upper 95

22 percent of 500 mR.

23 So those are three dose components. The

24 fourth and final one would be the occupational

25 medical dose. And this comes from medical
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1 monitoring that was going on at the facility,

2 where they were given chest X-rays during routine

3 physicals or during special screening that was

4 ongoing. 

5 In some of the early time periods we have

6 found evidence where if you worked at a uranium

7 facility, twice a year you were taken over and

8 given a chest X-ray. We're not quite sure why

9 they were doing this for just uranium workers,

10 but it's there in the records that this was going

11 on. I found it in procedures from Los Alamos in

12 1947 that this was going on. And so we're -- and

13 actually during a claimant interview they had

14 also indicated that every six months they were

15 marched over and given a chest X-ray for

16 monitoring.

17 What we're proposing is to look at the

18 number of the examinations in that year and then

19 the dose from the diagnostic procedure, and

20 summing them together for this occupational

21 medical monitoring dose.

22 The example that I'm going through right now

23 doesn't have a medical monitoring dose, which is

24 why now you'll see that for this particular

25 example that I've been going through this dose
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1 would be zero. They weren't monitored at all for

2 that year.

3 DR. ZIEMER: Tim, I assume now that on the

4 medical monitoring dose, whether or not you use

5 that would depend on the cancer site.

6 MR. TAULBEE: That is correct, yes. If it

7 is --

8 DR. ZIEMER: You don't automatically add

9 this in --

10 MR. TAULBEE: No, if they –

11 DR. ZIEMER: -- before you do probability of

12 causation, unless it would -- assuming it's a

13 chest X-ray and there's lung cancer, that's one

14 thing. If there's -- well, you know what I'm

15 asking.

16 MR. TAULBEE: Exactly. If there is a -- for

17 instance, if it's skin cancer and it's on their

18 hand, for instance, certainly we would not be

19 adding this in from that scenario.

20 DR. DeHART: But leukemia might be a problem

21 as well, with this as essentially a total thorax

22 radiation.

23 MR. TAULBEE: That is correct, yes. And the

24 actual -- there are some differences as to which

25 tissues get irradiated that I'll get to here in a
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1 minute with dose conversion factors, and that's

2 part of why we do this, because of the energy as

3 well.

4 Yes, Dr. Roessler.

5 DR. ROESSLER: I can picture this dose from

6 diagnostic procedures as being overwhelming any

7 other dose that they might have received to,

8 let's say, if it's a chest X-ray, to the lung.

9 And I can also picture that it will differ -- we

10 know it'll differ from year to year depending on

11 the equipment, and we know it's going to differ

12 maybe from one site to another. So it seems like

13 this, to really define this Di is going to be an

14 important part of what you do.

15 MR. TAULBEE: That is correct. We do know

16 in early years, from studies that have been going

17 on at NIOSH at some of these DOE facilities, in

18 particular the K-25 plant, the type of X-ray

19 machine that they were doing, and have come up

20 with dose calculations. In early time periods

21 the doses can be very, very significant,

22 especially when photofluorography was going on.

23 But now is -- more from a modern standpoint with

24 the standard 11 by 17 chest X-ray, the doses are

25 relatively low, orders of magnitude lower than
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1 what they were back in that time period. So,

2 yes.

3 DR. ZIEMER: Let me follow up on that. Are

4 there in the old records data sets that indicate

5 what the beam outputs were? Did people calibrate

6 those X-ray machines on site like they do in

7 medical facilities now, so we have beam output

8 data? Do we know that they had filtered beams

9 and so on?

10 MR. TAULBEE: In many cases from the

11 procedures -- one of the nice things about the

12 Department of Energy is you typically didn't do a

13 whole lot unless you had a procedure to do it.

14 And so a lot of this was documented in

15 procedures, and we have found some of the

16 evidence of that. Is it going to be the case at

17 all facilities? That I don't know. I would

18 imagine some of the smaller facilities with lower

19 budgets, this data might be more difficult to

20 come up with, in which case we're going to have

21 to do some general assumptions based upon the

22 larger facilities.

23 DR. ZIEMER: And I think there have been

24 studies on medical X-rays. I think the state of

25 Illinois, for example, looked at this
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1 extensively. And for given settings -- mAs, kVp

2 settings -- you get a wide variation of doses,

3 depending on such things as filtration of the

4 beam, that can really affect the patient dose

5 considerably, and film speeds and so on.

6 MR. TAULBEE: That is correct, yes.

7 MR. ELLIOTT: Just so we're all clear here,

8 this would be perhaps one element of additional

9 information we'd go back to the DOE site to seek.

10 And we're going to find verification of this

11 coming from the interview, but also when we go to

12 seek records from DOE to support this, we will

13 likely go to the medical files that may have not

14 been provided with the case file that we get from

15 Labor.

16 And additionally, I want us to make sure

17 that everybody understands we're not talking here

18 about diagnosis using X-ray or therapeutic

19 radiation from a medical standpoint from a

20 private, personal physician for health reasons.

21 These are occupationally-required medical

22 procedures to hold the job.

23 MR. TAULBEE: Yes.

24 DR. DeHART: Just as a point, and I don't

25 know whether this has been discussed anywhere
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1 along the way, but let's take a worker who's

2 injured on the job who -- for example, the back,

3 and undergoes a series of X-rays because of his

4 back. That's therapeutic, but it's job-related

5 under worker comp. Has that been touched at all?

6 DR. ZIEMER: You're complicating their lives

7 here, Roy.

8 MR. TAULBEE: We have had some discussions

9 about that, but in general what we're primarily

10 focusing on is just the screening, not from an

11 accident that would occur because -- from a

12 standpoint of a worker is injured, and they left

13 the facility and went to their own private

14 physician to get those X-rays. Then we would

15 have no knowledge of that particular information.

16 DR. NETON: I'd just like to add something

17 about the medical X-rays. Before everyone gets

18 the idea this is going to be enormously complex

19 and labor-intensive to do, we have to go back to

20 the efficiency process that we were talking about

21 earlier, where a person with a very low dose

22 record who had six or seven X-rays, if we could

23 take the highest X-ray output that we've seen and

24 add them to that person's record and it still is

25 non-compensable, then our work load is much less
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1 in that case. So this is only going to be

2 extremely important for these people who are sort

3 of on the borderline.

4 MR. TAULBEE: Okay. So now we've got the,

5 to recap, we've got a dosimeter dose

6 distribution, and then a missed dose distribution

7 and environmental dose distribution, and now we

8 need to convert these to an organ dose. 

9 The primary factor in the conversion to the

10 organ dose is what's the primary cancer. What is

11 the target organ, whether it's bone marrow for

12 leukemia; or lung cancer, the lungs; the liver.

13 For each different organ there are different dose

14 conversion factors that can be found in ICRP 74,

15 which is where all this data is coming from.

16 There's some additional factors affecting

17 the conversion, these dose conversion factors.

18 And that's the monitoring device, whether it was

19 a film badge or whether it was a TLD, and how it

20 was calibrated. Was it calibrated on a phantom,

21 or was it calibrated in free air? And then the

22 two other factors are the energy of the emission

23 and the exposure geometry.

24 To give an example of the monitoring device

25 and some of the differences you can see from a
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1 dose conversion standpoint, this is for the same

2 photon energy of 100 keV from the AP geometry, or

3 the anterior/posterior geometry from front to

4 back. You can see for three different organs of

5 interest the dose conversion factor can vary

6 quite widely, depending upon -- the red bars are

7 what we call the personal dose equivalent, which

8 is the modern standard, or Hp(10), and then the

9 green bars are the target dose per exposure or

10 per Roentgen, with a free air type of calibration

11 and no phantom. And as you can see if you look

12 at the lung cancer example, the dose conversion

13 factor would be .7. You take the monitoring

14 dose, multiply it by .7 to get the organ dose if

15 the monitoring data was in the modern standard of

16 Hp(10), whereas in the historic standard you'd

17 multiply by 1.1. So the dose, the organ dose,

18 would actually increase where -- by older

19 standards, and be decreased by modern standards.

20 But this is what the organ dose is to the

21 particular cancer site of interest.

22 Within the -- in looking at this particular

23 curve, the actual dose conversion factor is a

24 continuous function of photon energy that I'm

25 presenting here. This is the dose conversion
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1 factor for the Hp(10) or the modern standard.

2 And what you can see is, well, what value do we

3 actually use within this continuum of actual

4 values? 

5 And what I've -- this is for bone marrow and

6 from the AP geometry. And what I've got here is

7 three different -- the bars on there are set up

8 based upon the IREP program. There are three

9 photon energies that we have within there from

10 zero to 30 keV, from 30 to 200, and then greater

11 than 200 keV. What ICRP 74 recommends is that

12 you integrate the area under the curve to come up

13 with an average dose conversion factor over that

14 energy band, and that's what we've done in this

15 particular example.

16 Now in addition to the energy band is you

17 have the exposure geometry, which can also affect

18 the dose conversion factor. And if you look at

19 greater than the 200 keV component here, you'll

20 see that for four different geometries you can

21 come up with four different dose conversion

22 factors. So what we're concerned with is which

23 one -- what do we use in order to calculate what

24 the organ dose is from the monitored dose?

25 Well, what we've come up with is to use what
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1 I'm going to call the likeliest dose conversion

2 factor, and this is to use a weighted approach

3 based upon the job that the individual was doing

4 and knowledge that we have about the exposure,

5 and upon the interview, if they can give us any

6 information about what they were doing on the

7 particular job, where the hazards were located.

8 And in doing so, then we can weight their

9 percentage of time for the different -- for their

10 tasks in order to come up with this weighted dose

11 conversion factor. 

12 If you can think of, in the example here, a

13 person working at a glove box line, 90 percent of

14 their time they're going to have their hands in

15 the gloves, and the exposure's going to be coming

16 from the front of them in the AP geometry. But

17 walking in and out they're going to be walking by

18 glove box lines, and so they're going to have

19 more of a rotational type of a geometry. So

20 using the weighted approach, we can come up with

21 a weighted dose conversion factor.

22 Now we recognize this is quite uncertain,

23 that we don't really know for sure what exposure

24 geometry the individual experienced, how they

25 received their exposure. So what we're proposing
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1 is to use a range, from the lowest within the

2 energy band of interest to the highest dose

3 conversion factor. And since we know the lowest

4 dose conversion factor and the highest, and we

5 think we know what the likeliest is, we can

6 easily set up a triangular distribution.

7 And this gets back to how we came up with

8 this. We really don't have any other information

9 to try and base this on other than a lower bound,

10 an upper bound, and what we think the central

11 tendency of the distribution is. And so this is

12 why we're proposing to use a triangular

13 distribution for the dose conversion factor.

14 Now I've talked about the dosimeter dose,

15 the missed dose, the environmental dose, and now

16 dose conversion factors and how we get them all

17 into an organ dose. And then now the final

18 uncertainty, it's easier to describe altogether;

19 but as I mentioned, to recap the dosimeter dose

20 was a normal distribution. The missed dose was

21 lognormal. The environmental dose was lognormal,

22 and then the dose conversion factor is

23 triangular.

24 Using a Monte Carlo sampling technique, we

25 can go through and sample from each distribution
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1 in order to come up with what we think the

2 central dose estimate is for this individual and

3 to bound the uncertainty associated with it.

4 In walking through this slide here with you,

5 if you look at the top line only, what you have

6 is that initial dosimeter dose distribution

7 multiplied by the dose conversion factor will

8 give you the organ dose from the dosimeter alone,

9 from the measurements on the dosimeter. 

10 Within this dose distribution, multiplying

11 by the same dose conversion factor, you'll end up

12 with the missed organ dose. 

13 The environmental dose distribution, you'll

14 notice that the dose conversion factor is much

15 smaller from this case, and this is because, as

16 Dr. Ziemer pointed out, we're talking about

17 somebody immersed in a cloud, and so the exposure

18 geometry is isotropic. It's from all directions

19 at all times. Therefore the dose conversion

20 factor has a narrower uncertainty associated with

21 it. 

22 And when you multiply those two together,

23 you get the environmental dose distribution. You

24 add these three together, and you end up with a

25 final bone marrow dose for this individual.
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1 Now what I want to point out here on this is

2 in modern times, with quarterly monitoring using

3 TLDs at a detection limit of ten millirem, this

4 missed dose becomes relatively small. It's way

5 down here at the far end, with a maximum of about

6 40 millirem. In addition, the environmental

7 doses have also decreased over time because we

8 don't emit things out of the stacks like they did

9 back in the 1950s during the green runs and that

10 kind of thing. So these two components right

11 here will greatly decrease in more current times.

12 What's interesting is as you see -- as you

13 look at a person's dosimeter dose information and

14 where there's one of these changes that occurred

15 from a missed dose, you'll see the missed dose

16 will decrease and the dosimeter dose will

17 increase, because we started measuring more of

18 what we missed. And so you can see that in

19 individuals' exposure histories.

20 So what we end up here is with the bone

21 marrow dose associated with this particular claim

22 or individual. Well, upon inspection you can

23 generally see that it tends to follow kind of a

24 lognormal type of a distribution, which is

25 dominating by this missed dose being so large.
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1 However, if these two were small, you would see

2 it's probably going to follow more of a normal

3 distribution. 

4 And so we need to have some kind of a test

5 in order to determine which -- is it more

6 normally distributed or more lognormally

7 distributed. So what we’re proposing is to use a

8 goodness-of-fit test for normality. What I've

9 chosen to use here is the Chi-square goodness of

10 fit. And what this will tell us is what's the

11 tendency of that particular distribution, because

12 in IREP we have to pick one. You have to put in

13 one type of distribution and assess the

14 parameters associated with it. What you can see

15 from the Chi-square goodness-of-fit test, the --

16 it follows more of a lognormal distribution with

17 a geometric mean of 754 millirem with a geometric

18 standard deviation of 1.28.

19 I want to talk about the geometric standard

20 deviation a little bit here, because I've had

21 some questions from other colleagues who have

22 been plugging in some different geometric

23 standard deviations for different doses and

24 coming up with some really interesting answers

25 coming out of IREP. And part of that is because
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1 of the -- if you plug in like a geometric

2 standard deviation of five, well, you're going to

3 have a huge uncertainty associated with the

4 particular dose.

5 What you'll see here is the geometric

6 standard deviation of 1.2 is really too tight for

7 the distribution; 1.25 is pretty close, the

8 actual calculated value was 1.28; 1.5 is

9 spreading out the data too much, as well as 2.0.

10 So in going through this process of Monte Carlo

11 sampling, we can actually come up with what the

12 geometric mean is and the actual geometric

13 standard deviation. It can be calculated, and

14 that's what we're proposing.

15 So now that we've got this distribution, we

16 know the exposure year, the rate of exposure, the

17 radiation type. The example I just took you

18 though is photons greater than 200 keV.

19 Lognormal distribution, the median being .754

20 centisieverts, the geometric standard deviation

21 of 1.28, and that is the dose input for one

22 photon energy for one exposure year.

23 You go through this entire process and

24 repeat this process for each radiation type, each

25 energy, and each exposure year. If somebody was
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1 exposed to three of the three different energies

2 of photons and four different neutron energies,

3 that would be seven for each exposure year. If

4 they were at the site for ten years, that would

5 be 70 of these distributions to be developed to

6 enter the data into IREP. 

7 And with that, I'll answer any questions you

8 have.

9 DR. ZIEMER: Thank you, Tim. We obviously

10 had a number of questions as we proceeded, but

11 what about additional questions now? Comment?

12 MR. ELLIOTT: While you’re all thinking of

13 your questions, I would like to give you a little

14 bit of insight into how we come to be at this

15 point with our knowledge and understanding, and

16 what we're proposing here in dose reconstruction

17 as a process. 

18 What information besides the individual dose

19 badge results, bioassay results that we talked

20 about earlier, what information exists beyond

21 those at the sites?

22 This is a little book; it's titled Los

23 Alamos Handbook of Radiation Monitoring. It was

24 given to me yesterday. We know that these kind

25 of documents exist, have been prepared and
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1 distributed across the DOE complex. This is a

2 1958 third edition of this book. This book has

3 set some benchmarks for us in understanding this

4 time era and what the technology was capable of

5 doing for this time frame. Feel free to pick

6 this up and look at it. I ask you not to walk

7 away with it, and it is fragile. 

8 But it has information in here that is

9 relevant to what Tim has just presented to you.

10 It gives us an understanding of what the limits

11 of detection were for certain pieces of

12 monitoring equipment in use in this time frame

13 for this site. And we know from our experience

14 in research on these sites that Los Alamos --

15 what was used at Los Alamos was adopted at other

16 sites. What was developed at Oak Ridge was

17 adopted at other sites. What Hanford had in

18 place, they put in place from their own

19 experience and technological advances, as well as

20 those that were done at Los Alamos and Oak Ridge.

21 The medical diagnostic X-ray information is

22 listed in this book for this time frame, so we

23 have a source to go to. This is just an example

24 of the additional type of information we would go

25 back to DOE on certain types of claims and
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1 requests. We would accrete this type of

2 information to use on future claims relevant to a

3 given site. So feel free to look at this as you

4 wish.

5 DR. ZIEMER: Tim, I have a question on

6 missed dose that relates to neutrons. You didn't

7 really cover it here, but it is in your paper. 

8 We know that certainly in the early times

9 and to some extent even today there are certain

10 bands of neutrons not easily picked up by

11 dosimeters. You pointed out, for example, I

12 think, a case of knowing the thermal dose and

13 knowing perhaps the fast neutron and some band

14 maybe below 500 kilovolts or so that would be

15 missed. However, that's not new information. I

16 think the people at the time knew that they were

17 missing part of the band, and many -- I think in

18 many cases had algorithms that, based on what

19 their source terms were, that corrected for that

20 in the dose record.

21 I assume that you're not automatically going

22 to say that a dose was missed simply because of

23 some certain type of monitoring used, or you'll

24 use information like this, I guess. I'll answer

25 my own question, I suppose. But maybe you can
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1 clarify that issue on particularly missed neutron

2 dose.

3 MR. TAULBEE: That is absolutely correct.

4 There were some sites that did have algorithms

5 that were used, and we knew what neutron sources

6 they were using at the time period and how they

7 went about in doing their calibrations. We also

8 know that at other, some other facilities they

9 weren't quite that sophisticated at that time

10 period, and so there'd be a window of five or six

11 years where they weren't accounting for it. 

12 But we do go back and we look at what their

13 calibration procedures were for the particular

14 site at the particular time period in order to

15 determine whether or not we need to make this

16 additional correction that's discussed there in

17 the external guideline.

18 DR. ZIEMER: Jim.

19 DR. MELIUS: Can you give me an idea for the

20 example you presented here today how much person

21 time is involved in doing this calculation?

22 MR. TAULBEE: There's a lot of -- I won't

23 say a lot -- there's some development time in

24 setting up your spreadsheets in order to do this.

25 The program, the Monte Carlo sampling program
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1 that I used, was Crystal Ball, which is -- it

2 runs on a PC in an Excel type of format.

3 Plugging in the data takes some considerable time

4 to get there, probably a day or so to get

5 everything all set up. But then the actual

6 calculation when you run through it takes the

7 computer five, ten minutes. So the front-end

8 part is what takes the longest time period.

9 DR. MELIUS: So just so I -- for this

10 example, that would take some technical person a

11 day's worth of work to do this, or how would this

12 -- I'm trying to think how this process works, or

13 will work with your contractor and so forth.

14 What will be involved? Who will be doing what

15 and so forth?

16 MR. TAULBEE: Well, it doesn't take a full

17 day to enter all of this data at all, but in

18 order to enter probably 10 years or 20 years, or

19 10, probably 15 years of data, it could take you

20 a full day in order to get up to that. So it

21 really is dependent upon how long the work

22 history was for the individual and how complex it

23 is in order to come up with these calculations.

24 DR. NETON: If I could just elaborate on

25 that a little bit, though, there is a lot of
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1 detective work that goes into the up-front aspect

2 of this, which is what were the detection limits,

3 the medical X-rays, what type, what kVp or mAs

4 settings, that type of thing. 

5 So I think in the very beginning the dose

6 reconstructions are going to move slower because

7 we're setting the baseline for a lot of these

8 facilities. Once that's in place, then I think

9 what Tim is saying is true; then it's a matter of

10 setting up your spreadsheets and running through.

11 But for some of these smaller facilities we don't

12 know maybe about the -- finding out what the

13 exchange frequency was might even be difficult.

14 So there's a lot of front-end detective work

15 that I don't think we can say right up front that

16 it's going to take one day per dose

17 reconstruction. I think in the very beginning

18 it'll go slower, and then efficiency will take

19 over as time progresses.

20 DR. ZIEMER: Tim, I'm going to make a

21 comment here, maybe for you and Larry. 

22 Some of you know I retired recently, and I

23 was going through documents and tossing out stuff

24 like this (indicating) into my wastebasket. And

25 then I had this sudden flash in my mind, and I
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1 got on the phone and called Paul Frame at Oak

2 Ridge, who's a kind of a curator of old

3 instruments and documents, and I described for

4 Paul what I had. I said, Paul, I just filled up

5 a wastebasket with these old documents. He said,

6 oh, send them to me, so I filled up boxes and

7 sent them to Paul.

8 But it may be that if you're looking for

9 things like this (indicating) -- and Paul

10 probably has my copy of that Los Alamos one right

11 now -- but that would be a good source of old

12 documents from the DOE/AEC system, Paul Frame,

13 Oak Ridge National Lab. Or is it ORAU? ORAU,

14 yes.

15 MR. TAULBEE: Thank you very much, because I

16 don't know why, but many of the documents that

17 I've obtained so far have been from DOE public

18 reading rooms. And I know of Paul Frame, and I

19 know of his experience with historical monitoring

20 information, and I never really made that

21 connection. So thank you.

22 DR. ZIEMER: He may not appreciate my

23 volunteering his documents, but I think he does

24 want them to be useful to people, and more like

25 an archival library that might be helpful.
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1 Other questions? Okay, Wanda, please.

2 MS. MUNN: One other similar kind of comment

3 -- and again, I don't doubt that he'd appreciate

4 my commenting on this -- but I'm assuming that

5 you have checked with Ron Catherine (phonetic).

6 He also is a great collector of this type of

7 thing, and probably has several hundred boxes

8 stored in his basement somewhere.

9 MR. TAULBEE: Okay, thank you.

10 DR. ZIEMER: Yes, Ron Catherine's wife would

11 like you to get most of Ron's documents out of --

12 you probably shouldn't put that in the record.

13 (Laughter)

14 DR. ZIEMER: Other comments or questions?

15 (No response)

16 DR. ZIEMER: If not, we're going to adjourn.

17 Our experience last time indicated that sometimes

18 an hour for lunch pushes us a little. There's no

19 formal arrangement made for the lunch hour;

20 everybody's on their own. Last time we had a

21 list of eating places. 

22 Cori, do we still have a list somewhere for

23 -- it's out on the table or back here. So we'll

24 reconvene about 1:00 o'clock.

25 (Whereupon, a luncheon recess was
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1 taken from 11:40 a.m. to 1:10 p.m.)

2 - - -

3 DR. ZIEMER: We are ready to reconvene the

4 afternoon session. I'd like to remind members of

5 the public if you wish to make a public statement

6 later in the agenda, please sign up in the

7 booklet out in the foyer so that we can allot the

8 time accordingly.

9 I'd like to call on Larry Elliott briefly.

10 Larry, would you give us a, particularly for the

11 members of the public, an update on the comment

12 period for 42 CFR 82?

13 MR. ELLIOTT: Yes, Dr. Ziemer. 

14 Just so that everyone knows and for the

15 record, the public comment period and the

16 opportunity for the Board to get its comments in

17 on the guidelines for determining methods for

18 dose reconstruction, 42 CFR 82, are open again

19 during this meeting, and that comment period will

20 close March 1st for the public to provide any

21 further comments that they have. So March 1st

22 would be the deadline for the public to provide

23 written comments beyond this meeting.

24 DR. ZIEMER: Thank you. 

25 We'll begin the afternoon session with
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1 presentation on internal dose reconstruction, and

2 that will be given by Dave Allen, who's on the

3 NIOSH staff. Dave.

4 MR. ELLIOTT: As Dave's taking the podium,

5 if you look in your briefing book and you don't

6 find this presentation let us know, because we

7 just found that one member didn't have a copy of

8 it. So -- you don't have a copy, Rich?

9 MR. ESPINOSA: I've got a copy.

10 MR. ELLIOTT: Okay. 

11 I'm sorry; go ahead, Dave.

12 MR. ALLEN: No problem, Larry. 

13 Afternoon. My name, as the slide says, is

14 Dave Allen, and I'm here to talk to you about

15 internal dosimetry. Obviously there's no way I

16 can cover in great detail the entire

17 implementation plan in one afternoon, but I

18 wanted to try to touch on a couple of key points.

19 This slide is -- you've seen it before, once

20 last time -- and just as a little refresher, this

21 is the types of information we can use for trying

22 to reconstruct internal dosimetry. Bioassay

23 data, which is basically a direct measurement or

24 directly related to the actual intake a person

25 received; in-vivo is often referred to as a whole
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1 body counter. It's a way of counting the -- it's

2 assessing the amount of material in a particular

3 organ or in the entire body. The other ones you

4 see under bioassay are simply ways of measuring

5 concentration in different excreta to try to

6 assess how much uptake of a radioisotope a person

7 received.

8 Incident reports are on there simply because

9 they give you a lot of information. Obviously

10 there won't be an incident report every time for

11 every dose reconstruction we do, but they do tell

12 you all the upset conditions, if you can find

13 them. Upset conditions are very important

14 because a lot of the internal dosimetry is going

15 to rely on averages, so to speak. Anytime we

16 don't have the bioassay data we have to rely on

17 air sample data. A lot of times we're going to

18 be relying on the typical amount of work time a

19 person's in an area, or the typical air sample

20 concentration in that area. So upset conditions

21 are important for that assessment to get it

22 accurate.

23 And air sample data, like I just mentioned,

24 it's somewhat of an indirect way of estimating

25 the intake a person received.
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1 DR. ZIEMER: Dave, if I could interrupt.

2 Are you agreeable to allowing questions as you

3 proceed --

4 MR. ALLEN: Sure.

5 DR. ZIEMER: -- on this. And if you are,

6 let me insert one at this point, or maybe two. 

7 On bioassay data, you hadn't listed the

8 possibility of activated blood. There are cases

9 where certain -- well, criticality doses, that's

10 another -- or actually not just blood, but other

11 body samples activated. And then also things

12 like nose swabs.

13 MR. ALLEN: These were -- that slide was

14 intended for some examples of the type of

15 information. We can, of course, use a whole

16 myriad of information, and we intend to use

17 whatever we can find for the most part. 

18 Blood activation, like you said, that's -- I

19 think I'm being told to step closer to the

20 microphone. Blood activation from criticality,

21 that's more external for the most part. You do

22 get some activated blood, but that's as a result

23 of a massive external. But yes, like you say, we

24 can go ahead and assess the various elements that

25 were activated, and how much dose he's continuing
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1 to get from that, et cetera.

2 DR. ZIEMER: Yes, it's true that it is

3 external exposure; but it is, in a sense, a sort

4 of bioassay.

5 MR. ALLEN: Yeah, it's kind of a bioassay

6 for an external program. In fact, we were

7 looking at a paper recently on that.

8 To move on, bioassay is what we intend to

9 use primarily for the internal dosimetry. There

10 are several reasons why -- we will use a myriad

11 of information. We will try to use all the

12 information we can get our hands on. But

13 bioassay's got to be considered the primary

14 resource. 

15 The reasons for this I've tried to list up

16 here. The data is directly related to an

17 individual. Any other type of, like, say, air

18 sample concentration for inhalation exposure, you

19 have -- air samples are generally related to an

20 area. And somehow you have to then relate that

21 person to that area and for that time frame.

22 Also, the air samples inherently are

23 averaging over some period of time, such as an

24 eight-hour air sample is going to find an average

25 concentration for that time. If the person's in
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1 there for an hour, often he's -- the people are

2 doing the work and they are causing the airborne.

3 So that average concentration isn't necessarily

4 the greatest concentration to use. 

5 So preferably we'd be using bioassay. It's

6 more directly related to what the person

7 received.

8 I think I just basically covered the first

9 two on that one. And the last one, the data is

10 likely to be more retrievable. Air sample data,

11 contamination survey data, that sort of stuff was

12 typically considered project data, and it may or

13 may not exist after a project ends or a piece of

14 equipment is decommissioned. Sometimes that data

15 was not archived decades ago.

16 Bioassay data, on the other hand, it was

17 typically considered dosimetry data. It was

18 normally kept in a file with that person's name

19 on it, and is usually archived even after the

20 employment. We still expect to have some

21 problems getting some of this bioassay data, but

22 it's most likely we're going to get the best

23 handle on.

24 DR. DeHART: Help me understand -- this is

25 Roy DeHart -- help me understand. The half-life
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1 of a urine sample, for example, where there has -

2 - I can understand it when there's been a point

3 exposure. And the half-life I'm talking about is

4 not radioactive half-life; I'm talking about the

5 excretion half-life of whatever the salt or

6 mineral happens to be. I can understand it with

7 point. But if you're trying to monitor over

8 time, how do you consider that?

9 MR. ALLEN: Well, the way we do that is by

10 -- we use the same model that we're going to

11 determine the dose for the individual tissues.

12 This is the ICRP general biokinetic model, and it

13 describes different routes of entry and different

14 routes of elimination, and also the transport of

15 a particular radioisotope within the body. It

16 gives various rates for the individual organs to

17 absorb and to remove the various elements. 

18 Using this model, you can see where down at

19 the bottom you can determine at a particular

20 point in time how much of that radioisotope is

21 coming out in the urine or in other excreta.

22 What you get if you, say, get one quick

23 inhalation of some amount of plutonium, say, for

24 example, you would get a curve. If you were to

25 monitor the, say, urine, and check the
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1 concentration from day after day after day, you

2 would end up getting a curve similar to what you

3 were just talking about, some sort of decay type

4 of curve, which would look like that

5 (indicating). 

6 This one is an example. It's a typical

7 excretion curve, and this is for an acute

8 inhalation of insoluble plutonium. You can see

9 the time scale on the bottom is days after the

10 intake, and it does, believe it or not, go

11 through all that system and start coming out in

12 the urine very quickly after the intake.

13 DR. DeHART: I understand that for a point

14 exposure, a point in time. But are you using it

15 for monitoring over a period, over a length of

16 time when you don't know when the dose occurred,

17 and then try to use this to extrapolate back, or

18 –

19 MR. ALLEN: When we don't know when the

20 intake occurred?

21 DR. DeHART: Yes.

22 MR. ALLEN: Yeah.

23 MR. ELLIOTT: Did you guys work together –

24 (Laughter)

25 DR. ZIEMER: And could I insert in here,
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1 too, Roy, I think in principle for a sort of a

2 chronic case, you could assign -- if you go back

3 to the model, you could assign a rate of intake.

4 You could -- just like the excretion rate, you

5 could have, let's say, a constant intake rate,

6 and you could even have a model where you reached

7 equilibrium in some organ where the intake and --

8 so I think they can model it mathematically with

9 probably differential equations would do it if

10 you had the ideal case. Now obviously you're up

11 and down even in the chronic cases for different

12 inputs. But in principle, you can do that

13 mathematically.

14 MR. ALLEN: Yeah. I'm going to have some

15 more slides there, too. 

16 As you were mentioning, this one shows one

17 bioassay point -- if I can remember where the

18 pointer is on there -- that little dot right

19 there is one bioassay. Once you get this sample,

20 you get a detectable amount of plutonium in this

21 example, you still don't know how much intake an

22 individual received. Even if you know the type

23 of plutonium material and that it was an

24 inhalation, you still don't know how much.

25 The important parameter, as you were
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1 alluding to there, is the date. In this example,

2 that bioassay sample could correlate to a 1.3

3 picocurie intake inhalation, if it were to occur

4 two days prior to the sample. But it can be as

5 much as a 10 picocurie intake if it was 30 days

6 prior. That's almost a factor of ten. That's a

7 pretty large difference. So a lot of internal

8 dosimetry is ways to narrow down exactly what

9 that date was.

10 That's another reason the incidence reports

11 I was talking about earlier are very important.

12 They can zero in on the date right away. Also, a

13 lot of samples are taken as a result of an

14 incident, so you have some sort of information

15 that this is a non-routine sample. It was

16 probably taken the day of or day after an

17 incident.

18 One of those tricks -- well, for lack of any

19 other information, if we have nothing else we can

20 go on, on a routine sample like this -- like, for

21 example, if this was a 30-day sample frequency,

22 we would pick the midpoint, is the standard

23 philosophy. So on a 30-day frequency we would

24 pick the 15-day point. It's not necessarily the

25 most conservative, but you can see even at 15
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1 days it's fairly close to the most conservative.

2 If the intake occurred near that bioassay, we

3 would be overestimating by quite a bit.

4 Another method we have for trying to narrow

5 down that date with limited information -- this

6 looks like the same slide, but this is what

7 happens after an incident. Often you'll get

8 follow-up samples, or even any positive bioassay

9 sample, a lot of times you will get follow-up

10 samples. 

11 In this example I'm showing two additional

12 samples on here, and you can see even though this

13 is a nice and pretty theoretical curve here, but

14 you can see on this example how it would follow

15 that curve down. These three samples, following

16 that curve, you could line them up and say this

17 must be an inhalation that took place two days

18 prior to that first sample, so that correlates to

19 that 1.3 picocurie intake.

20 If the backup or the follow-up samples ended

21 up being pretty much the same level, you'd be on

22 this straight line here. You wouldn't

23 necessarily be able to tell the difference

24 between that 15-day exposure and that 30-day

25 exposure, but you would be zeroing in on the,
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1 say, nine to ten picoCurie intake range rather

2 than the one picoCurie intake range. So it might

3 not be a perfect way of doing it, but it will

4 zero you in on getting it close.

5 Now that was a nice, pretty, one acute

6 inhalation. This type of thing I've actually

7 seen. This is a theoretical example here, but

8 there is plenty of examples out there in real

9 life where it's not one nice, clean intake. It's

10 multiple intakes.

11 What I want to do is run you through this

12 example to show you what would happen in that

13 case. The reason this is a theoretical example

14 is this way I can show you what it really is. In

15 real life we would estimate it. We would know

16 we're pretty close, but there's no way we'd know

17 exactly what happened.

18 So what I've done here is I've picked some

19 random dates somewhat and some random intakes,

20 and I calculated out what the bioassay samples

21 would be on a routine frequency. And this is the

22 result there. These are bioassay samples on

23 particular dates. Then from that, the analyst

24 would not know this information here. I wanted

25 to show you how he can actually come up with
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NANCY LEE & ASSOCIATES

1 something relatively close.

2 Now here it's partially done. Obviously

3 it's not completely done. The purple curve is

4 the estimate, what the analyst would be

5 predicting to be bioassay from the intakes that

6 he estimated. On the first sample, with nothing

7 more to go on, I ended up picking the midpoint,

8 and from that midpoint I ended up picking 10,000

9 picoCurie intake, which turned out to be just

10 exactly what reality was. But again, the analyst

11 would have no way of knowing that.

12 Since that intake was off a couple weeks,

13 that air kind of starts promulgating it to a

14 point. The next intake I picked was April 1st,

15 and in reality we know that it was the end of

16 February. That's off by a month. I still ended

17 up with the same amount, but after that things

18 start getting a little bit off. When I'm to this

19 point here, I've got five intakes estimated. We

20 know for real there was five intakes. But in

21 reality, the analyst knows he's not done at this

22 point. He's going to assume there's another

23 intake that occurred at this point in here

24 somewhere; had to be.

25 So when he's all said and done, he ends up
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1 adding a couple more intakes. This large intake

2 here is the 15,000 picocuries you see, and that

3 ended up giving me a line that was a little bit

4 below here. When I added one more smaller intake

5 on this date, it brought it up to where it looks

6 like I have a scenario here that it seems like it

7 should be right. We know, because it's

8 theoretical, that it's not exactly right. The

9 scenario's off quite a bit on dates and on

10 numbers.

11 The key number, though, the important part

12 here, is that total. What I've basically done is

13 showed that there's two scenarios that could give

14 you the same bioassay, can predict the same

15 bioassay points, but they do give you the same

16 total inhalation intake. The scenario might not

17 be right, but the total should be relatively

18 close.

19 Another example on this, even if you knew

20 the exact dates of intake -- say the person only

21 went into an area at least five times. You know

22 the exact dates, you know when he had to have

23 these intakes. But say for some reason you've

24 messed up on the highest one here, and you call

25 it zero. Instead of 25,000 we know it is, he
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1 thinks it's zero. You still, in order to match

2 these data points here, he had to overestimate

3 those, not realizing it of course, but his

4 estimate here is considerably higher than what

5 reality was. Again we end up with the same total

6 intake.

7 Now this is obviously not going to happen.

8 Nobody's going to think that this is a good match

9 on this area of the curve right here. But

10 sometimes sample data is missing. Sometimes

11 samples get missed or routines get missed, or we

12 get a flawed sample. This graph here indicates

13 that even with a flawed sample or even with some

14 missing data, we can still reconstruct this

15 accurately.

16 Now the difference here, the effect it has

17 on dose, since this is an inhalation of some

18 insoluble compound, I figured the lung was

19 probably the biggest effect. What I've done

20 here, and I should have labeled it, is the annual

21 lung dose from -- this is for the actual case;

22 this is for what the analyst predicted

23 (indicating); and this is in rem, rem to the

24 lung.

25 You can see in 1979 they had the exact same
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1 numbers. That's because my estimate was exactly

2 the same. 1980, you can see the numbers vary a

3 little bit. That's because this 25,000

4 picocuries that really occurred, we estimated as

5 happening two and a half to four months later.

6 Therefore the lungs, with this material in the

7 lungs, the lungs were not exposed as long;

8 therefore they got a little less dose that year.

9 When you look down at the following year,

10 the lungs haven't had as much time to clear it

11 out. So now, by our models, we think there is

12 more material in the lungs than actually is, so

13 we're assigning more dose to the lungs than there

14 really was. So being off -- and in following

15 years, if I were to carry this on out further,

16 the differences get smaller and smaller, and the

17 total would end up being equal. 

18 So this shows even being off two and a half

19 to four months on this material, the difference

20 here is the biggest, and that's about a five

21 percent difference or so, give or take. So it's

22 still a reasonable estimate with limited

23 information, and in this particular case with a

24 couple samples missing.

25 Now somebody was mentioning earlier about
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1 chronic exposures, essentially. Chronic

2 exposures just -- not every time is it an

3 incident, and not every time does somebody get

4 one big inhalation of some material. Sometimes

5 it's a routine operation that has some low air

6 sample activity and the person is inhaling a

7 small amount every day. That would be a chronic

8 type of exposure, and that does affect the curve

9 somewhat on this elimination curve.

10 You can see on this graph, the blue line is

11 the one that you saw earlier. This correlates to

12 a ten picoCurie inhalation of insoluble

13 plutonium. The purple curve here is also ten

14 picocuries of insoluble plutonium, but this time

15 it's he inhaled one picoCurie a day each day for

16 ten consecutive days. So you can see a classic

17 chronic type of curve on this, but you also have

18 to notice that once you get 20, 25, 30 days out,

19 the difference is almost non-existent in this

20 example.

21 You also have to realize that this is a

22 30-day period. Bioassay samples are seldom more

23 frequent than a 30-day period, so there's going

24 to be one sample attained in that period of time,

25 more than likely. If it's caught in this point,
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1 we're going to either underestimate or

2 overestimate, depending on whether we think it's

3 a chronic or an acute exposure. 

4 But as I showed in the other slides, it

5 tends to come back around. If we've

6 underestimated on this exposure, we're going to

7 underestimate the effect of that exposure on

8 other bioassay samples down the road. And then

9 we'll have to estimate higher intakes to account

10 for those, or additional intakes to account for

11 those.

12 The reason this comes out to be pretty close

13 after only 20, 30 days is, in all reality, a

14 chronic exposure is just a series of acute

15 exposures. Since we probably don't have data

16 points to associate with all those, it can make a

17 difference in what we reconstruct. 

18 And I can show you that example here. What

19 I've done here is one more example or yet another

20 example, same type of thing as what I did before,

21 but this time the real dose is a chronic

22 exposure. So I took a -- I assumed a 1,000

23 picoCurie per day intake for 31 straight days, so

24 doing the math, that's 31,000 picoCurie intake. 

25 Now without -- same story again, without the
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1 analyst knowing that information, and he's going

2 to attempt to -- let's just assume that he

3 attempts to estimate this as an acute exposure,

4 or a series of acute exposures. It's pretty

5 clear when he looks at the data that something

6 happened in here, so he ends up taking a midpoint

7 and estimating a dose. When he takes the

8 midpoint between sample dates, it ends up doing

9 something like this. It overestimates the

10 bioassay samples down here, so he has to adjust

11 that date. He ends up adjusting the date up some

12 until some of these samples line up, like I

13 showed you in the one previous graph.

14 So I ended up choosing June 7th, and that

15 equated to a 28,000 picoCurie intake. That gets

16 you relatively close there, but obviously not all

17 the way there. What happens at that point is

18 then this curve is actually down below here, and

19 the analyst would have to either rethink it and

20 think it's a chronic exposure, or he's going to

21 have to assume there's some additional acute

22 exposures.

23 In this case, trying to estimate this as a

24 series of acute, you can see what the values are

25 I ended up estimating. Much smaller than that
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1 initial one, but they all tend to continue to add

2 up to where I ended with a total of around 30,000

3 picoCurie intake. 

4 So the 30,000 picoCurie intake compared to

5 the real intake of 31,000, it's 3-point-something

6 percent difference, less than a five percent

7 difference. And you have to remember, that's

8 without even trying to model it as a chronic,

9 without any other information, just simply

10 putting a series of acute intakes to try to mesh

11 the data.

12 Okay, I'm going to shift gears just slightly

13 here. It seems like it's a big shift, but it's

14 not. I want to talk about missed dose a little

15 bit. Missed dose, if you remember, is just a

16 person could receive a very small amount of

17 inhalation exposure and not submit a detectable

18 bioassay sample. It may not be enough to reach

19 the detection limits of the equipment. So the

20 question is how are we going to deal with that?

21 How are we going to add this back in?

22 I wanted to -- with the external dosimetry

23 you know detection limits for equipment, et

24 cetera, that once the badge is exchanged that is

25 gone. It's not true with internal dosimetry. As
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1 the other examples already showed you, once you

2 get an intake it's going to affect the bioassay

3 sample for quite some time. So this missed dose

4 does affect what happens after the fact. That's

5 the correlation effect I'm talking about on that

6 slide, must be correlated with subsequent

7 samples.

8 So I'm going to run through another example.

9 I'm going to take the previous example of the

10 chronic exposure. This time I'm going to assume

11 there's a detection limit of .022 picocuries –

12 not that that's a real number; it just worked

13 well on my slides. This time I'm going to assume

14 there was a missed dose, a missed chronic

15 exposure of 152 days consecutively, 87 picocuries

16 per day. 

17 It sounds like an odd number, I know, but

18 the reason I picked that number is that gets you

19 just below this detection limit on some of those

20 previous samples that we called zero. So that's

21 about maxed out in this case for that time frame.

22 And it doesn't end up, even though that seems

23 like a smaller number, it doesn't end up being

24 small. That adds 13,000 picocuries to what was a

25 31,000 picoCurie intake. So it's not a small
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1 difference, and that would be a significant

2 amount of missed dose if it actually were missed.

3 What I want to show you or what I want to

4 point out, like I said, is the bioassay samples

5 that come after that fact have to change. With

6 that amount of intake, that has to affect the

7 concentration in the urine after the fact. What

8 I wanted to point out is what would happen if the

9 analyst didn't consider the missed dose in this

10 example.

11 This was the previous prediction

12 superimposed over the new bioassay samples I've

13 calculated out. And obviously the analyst would

14 not have thought this was a good fit. These four

15 right here are the missed dose that I was talking

16 about. I put them on there simply to show you

17 where they are, but we're going to assume that

18 they're just recorded as less than minimum

19 detectable activity. So as far as we're

20 concerned, it's a zero there.

21 This obviously is much better fit. This is

22 what happens when he's taking this bioassay

23 sample, he's ignoring missed dose, and he's

24 trying to estimate this chronic exposure as a

25 series of acute exposures. With all those
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1 mistakes in mind, he comes up with a new estimate

2 of 41,000 picocuries. And we know -- he doesn't

3 know, but we know the real intake was 44,000,

4 which is approximately a seven percent

5 difference. Still not the end of the world. 

6 With little effort and without trying very

7 hard, making lots of mistakes, we're talking a

8 seven percent difference here in this example,

9 which is essentially what that says. And

10 remember, that missed dose, that 13,000, which

11 was not a small amount, there was no indications

12 that it ever existed. It was just recorded as

13 less than minimum detectable activity.

14 And again, that's because adding the missed

15 dose will -- if you were to go back now at this

16 point and try to add in some missed dose in the

17 beginning, you have to recalculate your predicted

18 bioassay samples that happen after that. If you

19 were to take that example, go back and try to

20 calculate some missed dose in the beginning, add

21 it to that, you're going to have to lower the

22 estimates on those acute exposures that you

23 estimated.

24 What it ends up happening, because I went

25 back and did that -- I'm not going to show you
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1 yet another graph of it, but I went back and did

2 that, and what I got was a five and a half

3 percent error instead of a seven percent error.

4 That shows you the difference in trying to

5 account for that missed dose or not account for

6 it. It didn't make a lot of difference. The big

7 difference here that the five or seven percent,

8 most of that is trying to estimate that long

9 acute or long chronic exposure as a bunch of

10 acute exposures.

11 So what it comes down to is if you have a

12 series of positive bioassay samples that you have

13 good readings on, if you account for the missed

14 dose or don't, it's not going to make a whole lot

15 of difference. We intend to go back and do the

16 best we can and try to estimate some of that, but

17 it very well could end up -- with other

18 information it could show us that there probably

19 was no missed dose, and if that's the case we'll

20 drop that value down. We'll be able to tell if

21 there was some missed dose or not once we have a

22 series of positive bioassay samples.

23 This graph shows you the other end of the

24 spectrum there. This is the same thing, just

25 stretched out over a longer time period. Once
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1 you've gotten a series of positive bioassay

2 samples, like I said, it's going to affect the

3 bioassay for some time to come. And I've got to

4 point out, this straight line is -- yes, it’s far

5 too straight; that's wrong. This line actually

6 should be down around in here (indicating). It

7 should have curved on down. 

8 But it does show you that it's well above

9 the detection limit for -- this is somewhat like

10 a 15-year time span in this example. So what

11 this indicates is once you have a series of

12 positive bioassay samples, it's very likely you,

13 by definition, don't have any missed dose after

14 that.

15 If you already accounted for enough intake

16 to give you detectable concentrations for years

17 to come, you can't have missed dose. You could

18 have a small intake that's lost in variations.

19 That's a matter of uncertainty, but it's not a

20 matter of missed dose at that point, which is

21 essentially all that slide is reiterating.

22 So as I said, these are examples of somewhat

23 trying to be careless. I was trying to be

24 careless and come up with the wrong answer, and

25 it was somewhat difficult once you got some data.
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1 So even though this seems like it's very

2 difficult, you can see where the data's very

3 important on a single intake. Once you get a

4 series of detectable samples, it really does end

5 up giving you the right total intake. You can

6 come up with that. You can determine the amount

7 on the missed dose, or at least account for it,

8 anyway. It's not as sensitive as you would think

9 at first glance.

10 That's essentially all I have for you,

11 unless you -- anybody have any comments?

12 DR. ZIEMER: Thank you, Dave. We probably

13 have a number of questions. 

14 Let me begin with one, and this may have

15 been addressed last time we met; I don't recall.

16 If you have a long-lived material -- that is

17 long-lived in the body -- such as plutonium, are

18 you truncating the dose calculation so that you

19 don't count numbers that are close to the time of

20 the identity of the cancer -- that is, dose that

21 because of time delays could not have contributed

22 to the tumor?

23 MR. ALLEN: No. We are calculating annual

24 dose to the tissue from the day he got an intake

25 until the day of diagnosis. IREP accounts --
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1 DR. ZIEMER: But the -- okay. I guess --

2 MR. ALLEN: IREP accounts for latency

3 periods, et cetera, so it'll essentially be -- if

4 it's a 20-year time span, he got 20 different

5 doses to, say, the liver and then he got liver

6 cancer, IREP will account for 20 different doses

7 and 20 different latency periods and essentially

8 sum all that up. So it give you --

9 DR. ZIEMER: Okay, it looks at each latency

10 period, though, so the dose -- the year prior to

11 the diagnosis will have, depending on latency

12 period, maybe no effect, then, on the --

13 MR. ALLEN: Right. It'll be accounted for,

14 but --

15 DR. ZIEMER: Accounted for, but then –

16 MR. ALLEN: -- there should be virtually no

17 probability from that.

18 DR. ZIEMER: Yes, got you. The weighting

19 factor will cover it. Thank you.

20 Now, Jim, did you have a question? Other

21 questions? Yes, Jim.

22 DR. MELIUS: And I apologize if I missed a

23 little bit of this, this has already been

24 answered. 

25 I'm, I guess, trying to figure out where
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1 some of this information's coming from, and

2 clearly this is going to be a difficult area to

3 piece together all the information on. As part

4 of your MOU with DOE, are you going to be

5 routinely asking for incident reports, or how is

6 that going to -- process -- or are you going to

7 wait until an individual reports it during an

8 interview? How are you going -- what's the

9 process? Is it a general request? Is it a

10 request at the time you are interviewing the

11 individual? Is it before that? How -- what's

12 that --

13 MR. ELLIOTT: It comes -- when we go after

14 incident reports, will come after the interview

15 has been done, after we've gained the information

16 from DOE, we've seen what kind of bioassay sample

17 results they have. Then we have the interview.

18 We augment that DOE information with the

19 interview information and any affidavits we might

20 have collected through the interview. Then we

21 go back to DOE and we say there appears to have

22 been some instance here where this individual

23 claims to have had an intake. We don't have

24 bioassay results to show that, perhaps, but we

25 need to see incident reports that might reflect
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1 that. So that's when we would go after it.

2 DR. MELIUS: Okay. And then what happens if

3 you get an incident report without any monitoring

4 being done, or monitoring records are not

5 available? There may have been monitoring, they

6 may be missing, may not have been done. What's -

7 -

8 MR. ALLEN: Well, again, we're going to use

9 whatever we can get our hands on, and if there's

10 an incident report there'll be at least some

11 contamination surveys done. We can, if nothing

12 else, we can take that and estimate an airborne

13 concentration for that particular intake.

14 DR. NETON: This is Jim Neton. 

15 I'd just like to expand a little bit on what

16 Larry was saying. What Larry said is true; we're

17 getting incident reports after we see some

18 evidence that there possibly was an incident.

19 But if -- I know some sites have the incident

20 reports in the person's own bioassay records and

21 files. And to the extent that they're in there,

22 we're certainly going to welcome them if they

23 come along with the case in the very beginning,

24 because it'll make our job a lot easier. But if

25 they do have to go back and dig, and these
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1 incident reports are buried somewhere like in the

2 medical records or some archived files, that

3 would be the path we would take later, then, is

4 to go back and try to retrieve them at that time.

5 DR. MELIUS: Just two questions in terms of

6 follow-up. One is -- is this more like

7 procedural -- are you ever going to present to us

8 how you're going to handle missing data as

9 opposed to missing doses, what we’ve talked about

10 here?

11 MR. ALLEN: One of those slides mentioned,

12 if you remember, at one point it mentioned a

13 couple of data points missing, still came out to

14 where I got the right estimate, as long as I had

15 some information and it was detectable

16 information on bioassay.

17 DR. MELIUS: I guess I'm not as much

18 directed it at you, but a more general question,

19 because it seems –

20 DR. NETON: Yeah, I think what Dave

21 addressed here is -- and he mentioned at the

22 beginning of his talk that it's impossible to

23 cover the entire gamut in half an hour or

24 whatever was allotted.

25 But where they're missing data, of course
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1 that's when we would go back and look at other

2 sources, which is covered, I think, in the

3 implementation guide, dealing with things such as

4 air sampling data to help ascertain the extent of

5 the level of contamination in the work place, co6 worker data, those sort of pieces of information.

7 And I think we've covered it in a general sense

8 to the best we could in the implementation guide.

9

10 But I don't think there's really any one set

11 formula that one can present for handling all the

12 different scenarios that might present

13 themselves. But we will use whatever's

14 available, whether it's air monitoring, breathing

15 zone air samples, co-worker data. And there are

16 some techniques out there for averaging adjacent

17 samples, those sort of things that we have

18 referenced. But I guess there's no one set

19 answer for that question.

20 DR. MELIUS: Yeah, and this is speaking, I

21 guess, personally -- I don’t know how the rest of

22 the committee feels -- but it seems to me that

23 that's going to be something that's going to be a

24 controversial issue on an individual basis.

25 That's going to be something of concern. 
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1 And so your procedures for doing that, I

2 think, are going to be important. They may

3 actually be very important for an individual's

4 dose, but they may also sort of be

5 psychologically or personally more important to

6 the individual. They're going to be very

7 concerned about this. And I would certainly like

8 to hear a presentation on that issue at some

9 point, because I think we're going to, as a

10 Board, have to deal with those questions and how

11 you're doing that. So I think in the future we

12 ought to be talking about that.

13 The other question I have relates -- and

14 this may be getting a little bit off your talk,

15 but I think it came up, at least the thought

16 occurred to me during your talk -- was the whole

17 security issue. My recollection from my former

18 work when it involved DOE facilities, a lot of

19 these incident reports and so forth were

20 classified, probably because they occurred way in

21 the past and there were security issues and so

22 forth. 

23 How are the security kinds of issues going

24 to be handled in terms of collecting information,

25 the interviews, what's presented to the -- what
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1 can be presented to the individual when you're

2 mailing information to them and so forth?

3 Because again, it seems to me that's going to be

4 an issue of concern to the individual, and yet

5 there clearly are security issues that arise in

6 doing that. Have you worked out a process for

7 that? Is this part of what you're doing with DOE

8 now?

9 MR. ELLIOTT: This is part of the MOU that

10 we need to strike with DOE. 

11 In our research experience and the MOU that

12 we had with DOE on that, we have a model to work

13 from, a starting point in that model. We have Q14 cleared staff who deal with classified

15 information of various types. Once we identify

16 from that information the relevant pieces that

17 are needed for whatever the work is, research, or

18 in this case compensation, we'd seek

19 declassification, or if that cannot be done, then

20 we seek a summary report that is declassified. 

21 We have to work out with DOE how this

22 information is going to be held, because we have

23 -- in HHS we have no classified vaults, per se.

24 When we get to the point of appeals and final

25 adjudication process, that's a whole nother area
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1 that we have to explore with DOE, on how a judge

2 can be brought into the understanding and

3 knowledge of classified information that has been

4 used to develop the case.

5 DR. MELIUS: I would just say I can see a

6 whole variety of -- where this is going to become

7 an important issue, and I'm glad you're pursuing

8 it.

9 DR. ZIEMER: Has there been any provision

10 either by NIOSH or DOE to consider taking

11 bioassay samples from individuals who may have

12 retired a number of years ago but for whom the

13 record indicates may have long-term body burdens,

14 and therefore, if the records are inadequate, get

15 some current bioassay samples?

16 MR. ALLEN: The only word I've heard on that

17 came from Jim Neton, so I'll let him --

18 DR. NETON: Yeah, we have thought about

19 that. There are some new bioassay techniques

20 such as thermal ionization mass spectrometry that

21 have detection limits an order of magnitude or so

22 below what's traditionally been used in the

23 workplace. In fact, I know out at Livermore

24 they're taking the old electrodeposited planchets

25 that were sometimes positive, sometimes not,
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1 redissolving them, reanalyzing them, and getting

2 very nice clearance curve data for some of these

3 workers.

4 So we've thought about it, but we've not

5 really considered it as part of our routine

6 program. It is cost-prohibitive. Those samples

7 tend to run several thousands of dollars per

8 analysis. However, it may be possible to use

9 them in some sort of a verification role in our

10 process, where if we sense that there is no --

11 say a claim is awarded and we take a sample, we

12 could verify whether or not it makes -- do sort

13 of a sanity check on what we've been doing.

14 That's not been clearly defined in our process

15 yet, but we certainly have thought about it.

16 DR. ZIEMER: Thank you. 

17 One question not related to that at all has

18 to do with the source term evaluations as a

19 method of determining body burdens when you have

20 to do that. You mentioned in your paper -- I

21 don't think you mentioned it here -- but in your

22 written paper the use of resuspension factors.

23 And I noticed -- the sentence says that if

24 limited information is known, conservative

25 default values for resuspension factors would be
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1 used.

2 What are these conservative default factors?

3 Does somebody have some generally-accepted

4 resuspension factors? I know there are tables of

5 these that people have proposed for decades, but

6 does anybody know of --

7 MR. ALLEN: There is no right answer on that

8 one –

9 DR. ZIEMER: -- what might become the

10 agreed-upon default values?

11 MR. ALLEN: There is no right answer, of

12 course, on that one. But like you said, there

13 are tables out there. I would think if you were

14 stuck using something to that as a fact, you

15 would go to the tables and go to the research

16 that is associated with those tables and see what

17 applies or if they apply to your situation, and

18 get the best --

19 DR. ZIEMER: So a priori, there are no --

20 MR. ALLEN: No.

21 DR. ZIEMER: -- resuspension factors that

22 you have said, these we will use.

23 MR. ALLEN: No. That's why I said the

24 conservative resuspension –

25 DR. ZIEMER: It'll be on a pretty much an ad
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1 hoc basis, that whatever seems to apply for a

2 given situation --

3 MR. ALLEN: Yes.

4 DR. ZIEMER: Right.

5 DR. NETON: We haven't committed to anything

6 on that line, but we have looked early on at the

7 use of values that are published in new Reg 1400,

8 which is the document that one would use to

9 determine if air sampling is required in the

10 workplace. And using those resuspension factors,

11 it starts with the old Allen Brodsky ten to the

12 minus sixth, and it is modified --

13 DR. ZIEMER: Right, the so-called magic

14 number --

15 DR. NETON: Magic number.

16 DR. ZIEMER: -- which is exactly what I was

17 leading toward.

18 DR. NETON: Exactly.

19 DR. ZIEMER: If all else fails, use the

20 Brodsky number.

21 DR. NETON: I'm not suggesting we're going

22 to use that, and if they have allowed for

23 modifications in 1400 to account for

24 dispersibility, confinement factors, those type

25 of things, whether it's a solid, liquid, gas, and
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1 ventilation. But I think that would be hard to

2 defend in a general basis across the board,

3 although they may have some value in bracketing

4 the potential as very low or very high, again in

5 the efficiency process.

6 DR. ZIEMER: True enough. But if in fact

7 they are in, for example, in a new reg or

8 something like that, I think they're a little

9 easier to defend if there is any question about

10 what you use. It seems to me something like that

11 is a little more defensible than, say,

12 arbitrarily picking up a Brodsky number or

13 something like that.

14 MR. ALLEN: Yeah, that's why I put it down

15 as resuspension factors, not just an arbitrary

16 number. I mean, it would be some table, some

17 published values. I'm just not willing to

18 commit, because there's so many different

19 situations. It'd be up to the analyst to

20 determine what best fits, and what would be

21 conservative if there's that much uncertainty in

22 it.

23 DR. ZIEMER: Uh-huh.

24 MR. ELLIOTT: Let me make sure we're clear

25 on a couple points here. 
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1 You're quoting from the draft implementation

2 guide, and one of the editorial things that we'll

3 have to make -- take account here and make change

4 to this draft is how we define certain words.

5 And when we're talking -- when we use this word

6 “conservative,” which I think is important for

7 everybody's understanding, we're talking that way

8 in regard to being -- giving benefit of the doubt

9 to the claimant, and so we're looking at worst10 case scenario. Those would be the things we

11 think of when we're saying conservative in this

12 approach.

13 DR. ZIEMER: Yes, I understand that. On the

14 other hand, I would not want the word

15 “conservative” to mean that as a worst case we

16 assume that all the material present gets

17 suspended, because that just does not happen. So

18 conservative might be taking a number of

19 published values for some nuclide under certain

20 circumstances and taking the most conservative of

21 those values, and that I could understand.

22 MR. ALLEN: Yeah, that's the intent of that

23 sentence.

24 DR. ZIEMER: Right.

25 MR. ALLEN: It was the conservative end or
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1 the claimant end of the realm of possibility.

2 DR. ZIEMER: Right.

3 MR. ALLEN: Or the realm of reality.

4 DR. ZIEMER: Jim has a question.

5 DR. MELIUS: Yeah, somewhat along these

6 lines of conservative and dealing with this

7 issue, but you presented a series of examples,

8 and I think they're illustrative examples at the

9 level that I could understand. 

10 Have you done a more formal analysis that

11 would look at the -- might be called a

12 sensitivity analysis or something to look at how

13 -- to try to put some parameters on when you have

14 to use certain assumptions or certain approaches?

15 And this sort of applied both here, but I think

16 more generally to this area where there's missing

17 information and so forth, that would let you

18 focus your efforts on certain types of data or

19 certain information and so forth? 

20 I mean, it just -- examples are nice, but

21 they're sort of selected out of a wide array of

22 potential problems out there.

23 MR. ALLEN: I don't know if I fully

24 understand what you're asking, but as far as like

25 a sensitivity analysis, put some parameters, some
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1 bounds on these. 

2 You have to remember, too, and I know I

3 didn't make that clear, all those examples were

4 for insoluble plutonium. It’d be a totally

5 different example for a more soluble form of

6 plutonium or for an insoluble uranium, or --

7 there's so many possibilities out there. A lot

8 of the actinines (sic) will end up giving you a

9 long curve, a longer half-life essentially for

10 that, so that the topic will -- applies to a lot

11 of the type of materials we will see -- not all,

12 but a lot of them. But the values and the

13 sensitivity changes, so it's hard to put a hard

14 core number on anything.

15 MR. ELLIOTT: If you recall Jim Neton's

16 presentation earlier, he talked about we -- in my

17 comment, in my presentation, we're being

18 progressive with delivering information, and

19 amount of information and level of technical

20 detail information. We gave you the rule first.

21 Now we're talking about implementation guidelines

22 under that rule on dose reconstruction.

23 Jim also on his slide showed technical basis

24 documents, and that's where I think this comes in

25 from your question. We have to work on given
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1 situations that are presented in cases to us,

2 working with our contractor to come up with a

3 technical basis on how we handle those things as

4 they present themselves, and then those are shown

5 to be established and used for the next case

6 coming along that is similar in nature and

7 situation.

8 DR. MELIUS: Just to elaborate, just -- I

9 guess what I'm trying to get also, are you doing

10 that, which is good, but also are you

11 prioritizing that effort so that your limited

12 resources are being spent on areas where it's

13 going to make the most impact in terms of cases?

14 And right, you're not going to know that until

15 you've gone through a number of cases, at least

16 not completely. 

17 But it's going to be important. You can

18 spend a lot of time doing some of this work

19 technically, but it's not going to make much

20 difference in terms of what a person's dose or

21 where they're going to end up in terms of

22 probability of causation. And so are you going

23 to focus it in that way also, because that seems

24 to me what would be important, given the

25 limitations on resources.
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1 MR. ELLIOTT: Yes, I -- very good comment,

2 suggestion; and we are. We're taking first

3 things first. And this is definitely on the

4 record now. That's something we plan to

5 incorporate as we move through, as cases are

6 presented and working with the contractor once

7 they're on board, to develop the technical basis

8 documents that serve as models for how future

9 cases are handled.

10 DR. NETON: One area I'd like to comment on

11 that I think we're looking at, and it's going to

12 pay off some large dividends, is how much effort

13 we put into refining the precision of these

14 estimates. 

15 It turns out for some of the more uncertain

16 risk models, if you spend a lot of time reducing

17 the uncertainty of the internal dose estimate way

18 down, you've wasted your time because it

19 virtually doesn't change the risk -- the

20 probability of causation at all, because some of

21 the models have so much inherent uncertainty

22 built into them. And IREP has a nice feature

23 that one can run, and it apportions the

24 probability -- uncertainty to the different

25 factors. 
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1 And if you run some of the more uncertain

2 models -- I think probably bone cancer is one of

3 those -- you'll find that no matter what you do

4 to beat your brains out to get the uncertainty of

5 the internal dose down, it's all driven by the

6 uncertainty in the models. And we can use that

7 to our advantage and not waste time trying to

8 refine these uncertainty distributions below a

9 certain level. I think that area is very, going

10 to be very fruitful for us.

11 DR. ROESSLER: You might be touching on an

12 area that I have a question with, I guess, and

13 that's in your report, which you didn't address,

14 but the organs not included in the ICRP models,

15 and how you come up with dose to them. Once you

16 do, it seems like you're going to have a lot of

17 uncertainty associated with it. 

18 And also, I'm thinking that these organs

19 might be some that a claimant might have cancer,

20 come in with the claim. These organs may very

21 well be some that are not associated very much

22 with radiation exposure, and on that case you

23 have a great deal of uncertainty. It just seems

24 -- and I haven't put it together mathematically -

25 - but it just seems like you have a real problem
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1 with uncertainties here.

2 MR. ALLEN: There's a potential problem

3 there, yes. I have played with some of the

4 possibilities. And as Jim was saying, there's --

5 or as you mentioned, some of these organs are not

6 very radiosensitive, so there's not a lot of

7 information, and ICRP did not deal with them very

8 well. 

9 The truth is, if they're not very

10 radiosensitive, the risk factors are usually --

11 should be somewhat higher. And as Jim pointed

12 out, sometimes they'll be compensated with the

13 uncertainty associated with the risk factor. And

14 the uncertainty associated with the dose almost

15 becomes irrelevant at that point. You can

16 calculate your best dose -- you're always going

17 to calculate the best estimate of what the dose

18 was, and if you go to the IREP program, you can

19 put in a large uncertainty for the dose or you

20 can put it in as a constant. If you find out on

21 both of those land on the same side of whether to

22 compensate or not, the uncertainty doesn't need

23 to be refined anymore.

24 DR. NETON: Yeah, but the bottom line, I

25 think, is that if an organ is not metabolically
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1 involved in the metabolism of a radioelement,

2 such as the prostate gland for a plutonium

3 intake, the dose is going to be extremely small.

4 And I think the concept of using that upper

5 bounding estimate and applying it to that organ

6 will demonstrate that since it's not

7 metabolically active there's very low dose, and

8 we can deal with it that way.

9 Now the prostate is one of the 36 organs

10 that ICRP models. I think the original question

11 was what about organs that aren't even in those

12 36, in the ICRP models? And I think I touched on

13 it last time, is the concept at this point is to

14 take the highest non-metabolically involved organ

15 and assign that dose to that organ. So if you

16 take the metabolically-active ones -- for

17 plutonium would be liver, skeleton and lung, if

18 it was inhalation, and the gonads are one of the

19 sites -- and then take the next lowest one. 

20 And what happens is that that would

21 essentially be the dose to the transfer

22 compartment, a partition among the volume of

23 blood that flows through that organ, and that

24 would be the dose assigned to the non-ICRP model.

25 Does that make sense?
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1 DR. ROESSLER: Yes, that makes sense. And I

2 think what you're saying is that that dose is

3 going to be low, and it --

4 DR. NETON: Yeah, it --

5 DR. ROESSLER: It doesn't really matter,

6 then, how --

7 DR. NETON: Right.

8 DR. ROESSLER: -- uncertain it is, because

9 it's going to be so low. And probably that's why

10 those organs are not included in ICRP to begin

11 with.

12 DR. NETON: That's right. That was my

13 thought process all along. 

14 And I think Dave knows this better than I

15 do, but I think if you look at it, I think

16 they're several orders of magnitude lower than

17 the metabolically-involved organs, typically.

18 And if we conservatively picked our next-highest

19 one that's not metabolically involved -- I'm not

20 sure that's the right word, but I think you know

21 what I'm talking about -- virtually it's almost

22 impossible to inhale enough material to get the

23 probability of causation up there for most of

24 them. I can't say we'd cover all possible cases,

25 but I'm pretty sure that's going to be the case.
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1 DR. ZIEMER: I think Henry's been waiting to

2 ask his question.

3 DR. ANDERSON: Yeah, I just wanted to follow

4 up a bit on that using sensitivity analysis. But

5 it's very difficult for us to address the issue

6 of your -- the thrust of the whole law is to be

7 conservative on the behalf of the client, and

8 that gives a certain sense of comfort if it is. 

9 But the bottom line question is how

10 conservative? And as we just heard, that in many

11 of these internal doses it ultimately makes no

12 difference in the probability outcome. And so I

13 think -- or it may not make much difference at

14 all because of a variety of factors, and

15 therefore while we're saying we're being

16 conservative there, in reality it's -- it isn't,

17 because it doesn't impact the outcome.

18 And what I'm asking is have you taken a

19 series of scenarios where you have -- and of the

20 most data you would want, and then remove some of

21 those data elements to see how does the system

22 operate when you have some of that missing, to

23 get a sense of is it always erring on

24 conservative side; and if so how much? 

25 Because you could have it go -- I think the
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1 last time we talked a little bit about that if

2 you have a great deal of data, that may in fact -

3 - because you reduce the uncertainty so much it's

4 not -- you're far more certain in the actual

5 dose, and this could then be to the individual's

6 detriment because now their probability drops

7 below, where if some of their data had been lost

8 the system would err on the other side. 

9 I think it's hard to understand --

10 MR. ALLEN: I realize --

11 DR. ANDERSON: -- how much of that is there,

12 and where are the soft points in this system that

13 may need to be subsequently tweaked. You could

14 either wait till you have a lot of field

15 experience, or you can take like the Monte Carlo

16 system and pick a number of these to run through

17 in a theoretic sense, and then have as the gold

18 standard a actual dose -- complete exposure model

19 that you would have and say what does it predict,

20 and then which of these elements are playing the

21 most in the system. 

22 Has any of that been --

23 MR. ALLEN: Long question.

24 DR. ANDERSON: Yeah, it's a -- I don't want

25 to read the transcript. I think you got the idea
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1 what I was trying to get at.

2 MR. ALLEN: I think I got the idea. If I'm

3 sure of what you're asking, you want to know how

4 much effort we put into determining what

5 individual parameters, how sensitive the dose is

6 to –

7 DR. ANDERSON: Yeah.

8 MR. ALLEN: -- individual parameters such as

9 maybe the date, et cetera. 

10 What you saw today was essentially our

11 effort towards determining how sensitive it was

12 to date, to the date of intake, or how sensitive

13 it was to chronic -- estimating it as chronic

14 versus acute. So you've seen a portion of it.

15 And no, we're not complete with that yet. And we

16 probably won't be complete with every possibility

17 when we start doing dose reconstructions. And as

18 Larry said, there'll be technical basis documents

19 coming up. As we need to learn something, we

20 will attempt to learn it. We will document it,

21 and we will finish that case. 

22 Does that make any sense?

23 DR. ANDERSON: A little. It's how do you

24 know, though? You'll go through it, you'll end

25 up with a result, but unless you run it through
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1 the model with multiple scenarios you won't

2 really get a sense of when you need more data or

3 not.

4 MR. ALLEN: Right. A lot of times we can

5 come up with -- if we're not certain about some

6 parameter, we can come up with various

7 theoretical scenarios and run through any number

8 of scenarios to see how sensitive it is that way.

9

10 As far as any other type of sensitivity, we

11 don't know exactly what intakes a particular

12 person got, so -- our whole job is estimating

13 these, so we don't have anything to compare with

14 it, once we've done our best job on that.

15 DR. ANDERSON: Yeah, but I'm focusing on the

16 model output, and therefore what goes into the

17 model. How it reflects reality is nice, but how

18 the model works and accounts for when things are

19 missing is where we get into how conservative is

20 the output from it. So if you kind of remove all

21 of the units, basically we're saying the outcome

22 here is 15 and the outcome here is one, and if

23 you change this one from a 1.1 to a 1.2, here's

24 what may happen. And that may be, again, the

25 question about defaults, for instance. Here, if
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1 you're -- depending on what your default is for

2 an internal dose, it becomes very important.

3 DR. NETON: Right. There are a number of

4 things we haven't talked about today, that I

5 think maybe I've given a misimpression that we're

6 always going to try to bracket these so that they

7 are not qualified for compensation. 

8 In fact, when we talk about conservatism,

9 there's a number of things we haven't discussed,

10 which is the default solubility classification.

11 If we did not know anything about what the worker

12 was exposed to, whether it was an oxide or a

13 nitrate, we would in a conservative basis -- that

14 is, a claimant-friendly basis -- use the most

15 insoluble material. For instance, if it was a

16 dose to the lung, that would be consistent with

17 the bioassay data we were presented. So that's

18 what we mean by being conservative, so the dose

19 would be an overestimate, but it would be -- it

20 would have to be an overestimate consistent with

21 the data that were presented to us.

22 Particle size is another area where we have

23 some latitude. The default particle size for

24 this model is five micron aerodynamic median --

25 activity median aerodynamic diameter. It's
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1 likely that many workers, particularly in uranium

2 fabrication facilities, were exposed to larger

3 aerosols. But unless we can demonstrate to the

4 contrary, we will use a more conservative default

5 size that would tend to maximize the worker's

6 dose because we couldn't prove otherwise.

7 So I don't know if that gives you a little

8 better sense. And we do need to look at those

9 parameters as to how much difference it makes;

10 you’re right.

11 DR. ANDERSON: That's really my point, is

12 that the five microns, if you assume it's 95

13 percent of them are below five or not, the

14 question is what difference does that make.

15 DR. NETON: Right, and --

16 DR. ANDERSON: And rather than say, well,

17 we're using the most conservative, it may be most

18 conservative by .2 percent.

19 DR. NETON: Right, and we're doing that, and

20 --

21 DR. ANDERSON: The workers, I think, are

22 going to want to know. They're comforted by

23 saying it's conservative, but you'd like to know

24 --

25 DR. NETON: Right, and we're doing this.
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1 And Larry mentioned that kind of one-step-at-a2 time approach. We just got finished doing a

3 comparison of this whole ICRP 66 default particle

4 size insolubility classes to the old ICRP 30, so

5 we're ready to address that issue if and when it

6 arises. So what you're suggesting makes a lot of

7 sense, and we need to do that.

8 MR. ELLIOTT: The accuracy we're trying to

9 achieve here is accurate decisions at Labor,

10 okay. And I think where your point is well taken

11 and where it comes to play is in those dose

12 reconstructions, in that middle group toward the

13 high end, say, 40 to 49 percent. And what do we

14 need to do, what do we need to understand about

15 the uncertainty, the soft points, what

16 contributes most to that probability of

17 causation? Is it the risk model? Is it the dose

18 reconstruction that went into the input

19 parameters of IREP? And those are the things

20 we're going to spend our time on looking at in

21 this point that you're making.

22 DR. ZIEMER: Thank you. Any further

23 comments or questions?

24 (No response)

25 DR. ZIEMER: Thank you, Dave. 
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1 We are due for a break, actually, and let's

2 take a break till 2:35.

3 (Whereupon, a recess was taken from

4 2:20 to 2:40 p.m.)

5 - - -

6 DR. ZIEMER: We have on our agenda a Board

7 discussion period. This was intended to be a

8 discussion of the two presentations that we just

9 had. However, much of that discussion has

10 already occurred. Let me just ask if any of the

11 Board members have any additional questions or

12 comments they wish to make relating to the

13 presentation by Tim Taulbee and Dave Allen. 

14 (No response)

15 DR. ZIEMER: If there are none, then I’m

16 going to proceed on the agenda, with the

17 permission of two individuals who have signed up

18 for public comments. 

19 Mr. Alvarez and Mr. Miller, do either of you

20 object to proceeding with your comments at this

21 time?

22 UNIDENTIFIED: No, we don't.

23 DR. ZIEMER: All right. Then -- well, we're

24 going to go alphabetically here. I always like

25 that because it makes me last. But Bob Alvarez
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1 will go first. And Bob, if you wouldn't mind,

2 would you use the podium up here, and then I

3 don't have to turn around.

4 MR. ALVAREZ: Yeah. Thank you for giving me

5 a few minutes. I won't take very long.

6 DR. ZIEMER: Bob is with the Institute for

7 Policy Studies here in the D.C. area.

8 MR. ALVAREZ: And some of you know me in

9 different, other incarnations. 

10 I wanted to cover a couple of issues with

11 you, and I'll be as brief as I can.

12 One is the, I guess, the basic overarching

13 question of conflict of interest. Given that

14 this was an activity undertaken by the Federal

15 government itself for a national security purpose

16 where people were put at risk in certain

17 instances under circumstances where deliberate

18 decisions were made to not provide protection or

19 not to inform workers, the fact that the

20 government itself is essentially the liable party

21 in this places, I think, a very -- an additional

22 special burden on this committee, on the

23 institutions of government that have to implement

24 this program, to address those issues. And it's

25 not easy to do, because the Federal government is
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1 the Federal government. But what I wanted to

2 propose to you is at least some possible ideas or

3 concepts to consider in terms of addressing this

4 conundrum.

5 One thought that I had, especially in terms

6 of the work that eventually will be undertaken by

7 whoever is chosen to -- as a contractor to

8 conduct the rather mammoth task of individual

9 dose reconstruction, is for this committee to set

10 up a subcommittee that would report to the full

11 committee that would be comprised of worker

12 representatives. 

13 That subcommittee should be provided with

14 necessary resources to hire technical people to

15 be able to do some quality assurance work on the

16 effort of the contractor, particularly with

17 respect to review of work scope, spot-checking

18 ongoing work, and at least some sort of review of

19 the general approach that's going to be

20 undertaken; and for the committee to do some

21 periodic spot-checking and reporting to the full

22 committee itself, not being separate, but being a

23 function of this committee.

24 It would be a way, I think, of adding a

25 layer of quality assurance; but I think also, in
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1 a way more important, adding, I think, an element

2 that could really build public trust in this

3 process. And I think public trust is very, very

4 important to this.

5 The second sort of issue that I wanted to

6 raise with you really has to do with where this

7 committee will be heading once this is -- once

8 the individual dose reconstruction issues are

9 addressed, and that is the issue of the special

10 cohorts themselves. And I think -- as you know,

11 if you look very carefully at the circumstances

12 that led to the enactment of this law and the

13 issues that were raised, is that we're not just

14 dealing with an issue of dose and effect and

15 response. We're dealing with social policy. How

16 do we -- how does science inform social policy,

17 which has to do with making right with the past?

18 And then you get into questions of ethics.

19 And I think this committee should consider having

20 on its -- as one of its members an ethicist,

21 because there are circumstances when you start

22 especially to get into the issue of the special

23 cohort, if you see -- if some of you who were

24 around or if you look back at some of the

25 legislative history that led to the creation of
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1 this particular provision of law, was the

2 revelation that there were workers who were put

3 at -- knowingly put at risk without their

4 knowledge, and were denied any protective

5 measures in a deliberate manner. 

6 The infamous 1960 memo that came out of

7 Paducah where someone was asking if -- was

8 pointing out that workers were probably getting

9 heavily exposed to neptunium particularly in the

10 fluorination processes, the bag house workers,

11 people who were hitting large cloth bags laden

12 with neptunium with metal rods in street clothes.

13 And the reply that came back was we are not going

14 to measure them, any exposure for neptunium. We

15 are not going to provide them with necessary

16 protection. And by the way, there was also a

17 request to do postmortem. We're not even going

18 to look at them after they die, because we are

19 afraid that this information would lead to the

20 union demanding hazardous duty pay.

21 There is a huge ethical issue being put on

22 the table by that memo. I think you need someone

23 to help you sort these kinds of issues out

24 because there were decisions made, shortcuts

25 made, and the like.
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1 I also want to draw your attention to an

2 effort that came out in March of last year that

3 has never really -- that was never really

4 completed, but it is what it is, which was an

5 attempt to establish an understanding of the mass

6 balance flow of recycled uranium in the

7 Department of Energy complex. This undertaking

8 sort of went to a preliminary phase, and then was

9 shut down when the new administration came in,

10 and it never really sort of went further beyond

11 that. 

12 But that particular set of studies,

13 documents, I think, provides some very important

14 insights. Approximately a quarter-million tons

15 of uranium was recycled for the purposes of the

16 United States nuclear weapons program. That's a

17 very large amount. That material wound its way

18 throughout many of the existing plants and a lot

19 of defunct plants, and to a lot of outsourcing

20 facilities that were doing contract work for the

21 AEC during the fifties and sixties. 

22 And I'm mindful of a couple of things. For

23 example, in reviewing the Hanford report and the

24 Oak Ridge site-specific reports, it was very

25 clear in these reports that the initial product
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1 that was coming out of the U tank, the tank

2 farms, from the U farm where they were extracting

3 uranium from waste that was coming out of the

4 bismuth phosphate extraction process, that that

5 plutonium did not meet spec for Oak Ridge. In

6 other words, there were excessive levels of

7 plutonium in there, and Oak Ridge was rejecting

8 this, not for health and safety reasons, because

9 they were just starting up their gaseous

10 diffusion plants and didn't -- were afraid of,

11 quote, gumming up the works.

12 So what happened when they weren't meeting

13 spec? This material wound up in Cleveland, Ohio,

14 in Harshaw, and those workers conducted the

15 fluorination process, which had the effect of

16 reducing the plutonium content that made it

17 allowable to be received by Oak Ridge. And think

18 about those workers who might have been hitting

19 cloth bags laden with neptunium and plutonium

20 from the first batches coming out of the U tanks.

21 These are issues that I think you really

22 need to look at. And I think it's important to

23 look at these issues as you start to move toward

24 the special cohort problem in the context of

25 understanding the flow sheets. There are still
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1 flow sheets that are still not public that need

2 to be addressed. For example, we really know

3 very little about the thorium U-233 flow sheet of

4 the AEC/DOE. Where did all that stuff go, who

5 handled it, what was going on? Ultimately at

6 least a ton of uranium 233 was produced, and it's

7 sitting around at the DOE complex. There was a

8 flow sheet involving this. Where is it? Where

9 were those workers?

10 I also think that some of the work that has

11 been done in the past in the previous years,

12 particularly in the year 2000, looking at the

13 occupational -- the history of occupational

14 protection at the gaseous diffusion plants that

15 was done by the DOE Office of Environment Safety

16 and Health, I think, are very instructive. 

17 And it would be useful to have more of these

18 studies done as you pursue that issue of the

19 special cohort, because these are things that --

20 where you need to have -- it's almost like

21 putting together a painting where dose

22 reconstruction, in and of itself, gives you some

23 part of the image, but to really get the image

24 sharper in focus and add more to the picture

25 itself, you have to start to look at the issues
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1 that were swirling around at the time -- whether

2 or not, for example, there is any evidence that

3 workers were knowingly put at risk and no

4 protective measures were provided in a deliberate

5 manner. 

6 You have to look at whether or not any of --

7 what kinds of jobs really have -- may constitute

8 high-risk jobs from the point of view of a

9 special cohort, again looking at the -- for

10 example, workers who may have been handling

11 uranyl nitrate in the calcining operations in the

12 300 Area at Hanford when they were getting the

13 first batches out of the U tanks and converting

14 that material.

15 What's abundantly clear in the DOE report,

16 the site-specific reports about recycled uranium,

17 is that, one, there were no protective measures,

18 no limits set for exposure to neptunium,

19 technetium, or plutonium, for that matter, in

20 these settings, and that each site had its own

21 way of measuring for it for purposes of material

22 transaction, which leaves huge questions about

23 inventory discrepancies. 

24 So these are things that I'm just urging you

25 to think about as you move forward in terms of
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1 establishing a conceptual basis for addressing

2 special cohorts.

3 Thank you very much.

4 DR. ZIEMER: Thank you, Bob. Before you sit

5 down, let me ask if any of the Board members have

6 questions that you'd like to address to Bob, or

7 things for clarification?

8 (No response)

9 MR. ALVAREZ: Thank you.

10 DR. ZIEMER: Thank you. Next we have

11 comments by Richard Miller from the Government

12 Accountability Project. Richard.

13 MR. MILLER: Good afternoon. I would be

14 remiss if I didn't come with handouts, and so I

15 have. I was even thinking about handing out what

16 I handed out last time so we could talk about it

17 again.

18 I'm going to sort of touch on a number of

19 points very quickly. I am also going to pass

20 around, once you have that memo in hand, a

21 picture. I don't have one of those beautiful

22 overheads to make it visible for everyone.

23 But today's discussion on dose

24 reconstruction -- and I may be misreading both

25 the guidance for internal and external, and I may
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1 be misreading the rule in terms of the process

2 steps that are followed -- but the appearance is

3 that NIOSH will receive initially internal and

4 external dose badge -- internal bioassay data and

5 external dose badge data, and then based on that

6 two things seem to happen. 

7 One, there's a culling process that goes on

8 that seems to weed out low dose and sort of the

9 obvious high dose cases, and the high dose cases

10 that may be eligible you sort of push through.

11 But then there seems to be this second step,

12 which is that if you're not sort of weeded out

13 presumptively and you go through an interview

14 process, there is a -- it appears to be that

15 there is a presumption of regularity in the dose

16 record unless either the interview or some other

17 intervening event clues the folks who are the

18 contractors doing the dose reconstruction that

19 they should not presume that this paper record,

20 as delivered, can be massaged and analyzed as it

21 was in our presentations today.

22 Now both the legislative history of the Act,

23 and more particularly some of the studies that

24 actually Bob Alvarez mentioned earlier on the

25 history of the radiation protection programs --
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1 and this was done at Portsmouth, Paducah, and Oak

2 Ridge with special allocated funding by Congress

3 at some expense, with a team of about 35 people -

4 - not quite a tiger team, but reminiscent of --

5 and conducted in cooperation with the unions at

6 these three sites in order to encourage a high

7 degree of participation in interviews. 

8 So many people received information under Q9 clearances, and needed to be encouraged they were

10 comfortable to disclose what they knew.

11 Secondly, people were concerned about retaliation

12 if they're active employees, which they were in

13 many cases. And the union actually sort of

14 nudged people and say, it's okay to talk to these

15 guys, right? Don't be shy.

16 Well, out of the course of approximately 125

17 transcribed interviews done at each site -- there

18 was about 375 transcribed interviews, coupled

19 with an extensive paper review of not -- and the

20 interviews were done with both hourly and

21 salaried people in health physics and management,

22 as well as on the ground floor in production.

23 And what came out of at least those three reports

24 was that the history of radiation protection is

25 pretty darned spotty. And let me just give you
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1 sort of some of the kind of interesting findings.

2 One was that they -- for many years you had

3 the Monday morning urinalysis that was provided.

4 And that was sort of a point of bemusement,

5 because after you'd spent a good weekend drinking

6 some beer, if you had soluble uptake most of it

7 was gone by the time you were there. Now that

8 was good for flushing it out of your system at

9 the beginning of the week to set a baseline, but

10 it might not have been too good at capturing what

11 happened the week before. And so you had

12 corrections over time to improve and obviously

13 avoid and create obvious post-incident and other

14 forms of sampling methods, but you saw a lot of

15 irregularity. 

16 You had irregularities with respect to even

17 external monitoring. We saw for the people who

18 were involved in making uranium derbies from

19 magnesium reduction furnace -- in the magnesium

20 reduction furnaces, and they were told to go in

21 and chip all the slag off, right, to get the

22 uranium derby out. Well, lo and behold, they

23 didn't have any extremity monitoring.

24 Bob Alvarez talked about the poor folks who

25 had to go into the bag houses with the caked,
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1 thick dust that was -- with very high

2 concentrations, up to 15 percent of neptunium

3 237, and take steel rods and literally beat the

4 bags, and you have big clouds of dust. This

5 doesn't turn up in the dose record, and it

6 doesn't turn up in the paper record very readily.

7 It came back through sort of historical research.

8 And so the challenge that I saw was, whether

9 it be at -- or take a good example at Portsmouth,

10 which NIOSH actually was quite instrumental in

11 uncovering, was the absence of neutron

12 monitoring. You had freeze-outs in the uranium

13 enrichment process which would lead to what folks

14 euphemistically referred to as the slow cooker

15 effect, and you would have unmonitored neutron

16 exposure. 

17 Now only certain people would be even

18 potentially at risk, mostly maintenance people.

19 But you don't have any dose record with which to

20 come back and sort of reconstruct it. Was it

21 significant, was it not? That's certainly

22 debatable about the degree of significance, and

23 some have suggested you go back and re-examine

24 the glow curves. But it's going to be quite a

25 challenge where you don't have monitoring to
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1 start with.

2 So the concept of missed dose, as I sat, at

3 least, in the back row today and watched it, I

4 had a different meaning of the word “missed

5 dose,” and it's not that which is unrecorded

6 because it falls below the limits of detection.

7 It's purely either unmonitored for dose or

8 improperly accounted for dose. And so the paper

9 record itself doesn't provide a very firm

10 foundation.

11 Now how do you get clued in that that paper

12 record is or is not a good basis? And what I

13 don't get is, from reading the rule, is what

14 automatically makes the contractor leap into the

15 sea of all of the other forms of information that

16 can be out there. Most of the occurrence reports

17 at certain sites have never been made public. 

18 For example, at Los Alamos they have never

19 been made public. That's a very interesting

20 source of data which is not organized in

21 electronic form, and if you don't have those

22 occurrence reports readily available or the

23 claimant doesn't have the ability to go and get

24 access to them, and NIOSH isn't clued in as to

25 whether there was even an occurrence report
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1 associated with a particular event, you're left

2 with, as a claimant, operating in a vacuum.

3 What's to push it forward?

4 Well, it seems to me that two things serve

5 as sort of important obstacles in what needs to

6 be done. The first obstacle is what I see in the

7 request for proposal for the contractor. And the

8 obstacle that seems most evident is -- and I'll

9 just read it here from the RFP on dose

10 reconstruction research:

11 (Reading) NIOSH does not expect that the

12 contractor will be responsible for the physical

13 collection and retrieval of records at the DOE

14 and DOE contractor facilities.

15 And then it goes on to say:

16 (Reading) Plans for site visits and the

17 research to be performed must be approved by

18 NIOSH.

19 DOE, on the other hand, is the single

20 largest impediment to NIOSH's access to this

21 information, and the biggest single opportunity.

22 And at this point, if the contractor doesn't have

23 the freedom to in effect go do a deep dive on

24 what's in the vaults, and you're left with what

25 DOE chooses to give you and rely in large part on
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1 what the claimants may be able to tell you as

2 best they can recall, recognizing they operated

3 for many years on a need-to-know basis, this

4 process seems significantly disadvantaged.

5 And one way to crawl out of this -- and it's

6 clearly not something that you've gotten a

7 statutory directive to do, so this is not implied

8 as a criticism of your failure, NIOSH's failure

9 to do what they should be doing -- but the kinds

10 of reports that were generated by DOE sort of for

11 the three GDPs gave us a road map, as it laid out

12 the systemic irregularities in the entire system

13 of radiation protection from the beginning of the

14 sites up to present.

15 And you can -- that tells you a lot about

16 what kinds of questions you need to ask. And

17 most sites don't have that. Most sites don't

18 have that history laid out. And I don't know

19 whether NIOSH is going to be in a position to do

20 it. But it seems to me absent that, claimants

21 are going to be clueless, in many respects, to

22 direct you around whether the systemic

23 programmatic approach was proper or improper, and

24 whether the paper record that underlies it has

25 any basis. And that's a larger question than
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1 many claimants can surmount.

2 Secondly, I wanted to talk a little bit

3 about -- just very briefly -- this memo I passed

4 out. Bob actually -- Bob Alvarez unfortunately

5 stepped on my story a little bit, but this was

6 the famous Paducah memo. And I don't know if any

7 of you had seen it before, but I want to just

8 highlight it because it's hard to read. It was

9 never of very good quality. It fell out of the

10 drawer, so to speak, when the Office of

11 Environment Safety and Health went to do its

12 oversight assessment. It never surfaced in all

13 of the years of litigation, worker comp claims

14 that had been brought at that site. I don't know

15 how this thing never came to light for all of

16 these years, but it was sitting in the file

17 drawers.

18 Nevertheless, there it is. And what it

19 says is that workers were handling neptunium 237.

20 It was in a very fine particle form, about a

21 half-micron in diameter, so the masks that -- the

22 respiratory protection they had was completely

23 inadequate, even if you wanted to put those old

24 World War II Army masks on in these very

25 physically hot facilities inside. And what they
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1 found was, if you look -- I don't know -- it's on

2 page two here, it says that they were supposed to

3 wear nose and mouth face masks, and there's a

4 little part marked in the right-hand column:

5 (Reading) I watched one man push up his

6 mask, smoke a cigarette using potentially

7 contaminated hands and gloves. They've devised

8 some air scoops, but lo and behold, it doesn't

9 seem to be a very good job of ventilating the

10 cascades when they cut them open.

11 The conclusion of the memo on page three is

12 that there are possibly 300 people at Paducah who

13 should be checked out -- this is for neptunium

14 237 -- but they -- I presume referring to the

15 contractor, in this case Union Carbide --

16 hesitate to proceed to intensive studies because

17 of the union's use of this is an excuse for

18 hazardous duty pay.

19 They then go on to suggest, well, look -- on

20 page four -- you know, we really ought to go

21 ahead and do some toxicological studies here. We

22 should get our arms around this. And they

23 pointed out the need to get postmortem samples on

24 any of these potentially contaminated met -- this

25 is on the top of page four -- for correlation of
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1 tissue content with urine output. And the memo

2 goes on to say:

3 (Reading) But I'm afraid that the policy at

4 this plant is to be wary of unions and any

5 unfavorable public relations. So they weren't

6 willing to test the living, and they weren't

7 willing to test the dead. 

8 So you get to the bottom of the memo, and it

9 says, well, it appears we've got a neptunium

10 problem, but we don't have the data to tell them

11 how serious it is, and on life goes.

12 Of course, the workers were never told about

13 this. And the first monitoring for transuranics

14 was conducted at that site on a voluntary basis

15 in 1992, so some 30-odd years later. And even

16 then there wasn't a mandatory transuranic

17 bioassay program for several years thereafter.

18 And you know, the only reason people even knew

19 that these materials were in use and that there

20 should be some assay program was because the

21 newspapers were reporting they were finding it in

22 ground water.

23 Now when the Department of Energy ended up

24 contracting for sort of some kind of general

25 exposure assessment at this plant, one of the
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1 things that was startling was that although there

2 were very low quantities of neptunium 237 in the

3 parts per million range in any given ton of

4 uranium, what they discovered was that this stuff

5 preferentially accumulated and deposited out on

6 certain pieces of equipment. And only when you

7 cut them open to do maintenance work -- say the

8 compressor blades, for example, where you had to

9 take the barriers apart -- would you wind up with

10 up to 55 percent concentration of neptunium 237.

11 And there was no radiation protection program in

12 place, and all of the paper trail that existed at

13 that site which sought to assess this risk never

14 accounted for that.

15 Now we've been blessed with a lot of money

16 being spent on answering the questions about what

17 happened to people in the feed material building,

18 the 410 building and others at Paducah. And so

19 now, today, lay people like myself can talk about

20 it with some degree of confidence because it's

21 been so well-documented. 

22 What do you do, though -- and this is the

23 challenge, I guess -- how do you get this kind of

24 understanding at many of the other types of

25 facilities in terms of the vast missed dose
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1 problem? Because to me this is what missed dose

2 is. It's not whether it goes unmonitored below

3 the limits of detection. It's do you -- is this

4 going to be a case of garbage in/garbage out in

5 terms of dose reconstruction, with high degrees

6 of precision and error bars around measures of

7 central tendency that bear no relationship to

8 what is an accurate characterization of what

9 happened? That's a real challenge.

10 And we shouldn't be misled by the high

11 degree of precision that we saw in terms of

12 estimating the tweaks around the uncertainties

13 when we may be missing the forest for the trees.

14 And frankly, if you went and picked up the

15 telephone and started interviewing workers at

16 Paducah three years ago, before this story broke

17 on the front page of The Washington Post, they

18 couldn't have told you one iota about it. They

19 couldn't have told you.

20 So this is a real challenge, and I think

21 it's such a profound challenge that I would

22 encourage you perhaps to sort of -- both to

23 inform as a process step, and secondly maybe as a

24 recommendation to the Secretary -- hint, hint --

25 that you bring a panel in of folks who've done
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1 this kind of what I would call forensic dose

2 reconstruction, which is very much what you're

3 doing here, right? You're trying to basically

4 come in and pick up the scene of what in some

5 respects were either cover-ups or mismanagement

6 or error, or maybe well-managed programs, but for

7 which in many cases there's a high degree of

8 irregularity.

9 The tiger team reports, when Dr. Ziemer was

10 at DOE, and Leo Duffy and you and Admiral Watkins

11 were pushing these tiger teams through, and

12 although it became a dirty word to talk about how

13 wonderful tiger teams were when the next

14 administration came in, those reports uncovered

15 extraordinary irregularities in your radiation

16 protection programs. And these really should be

17 the centerpiece about informing the

18 questionnaires and the thinking that goes into

19 it.

20 Now perhaps -- there's been some interesting

21 dose reconstruction projects underway. There's a

22 very expensive one underway now in its concluding

23 phases at the Mound facility that MJW has been

24 doing as an outcome, frankly, of litigation that

25 was brought there for the failure of the
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1 radiation protection program. 

2 And it will be very interesting to sort of

3 hear how did they attack those problems, and what

4 were the records access issues they dealt with.

5 Because one of them, we learned, was that the

6 books -- much of the data was handwritten in

7 books, and the books were shipped to Los Alamos -

8 - I mean, to Albuquerque, and they were stored in

9 warehouses far from the Mound facility. And then

10 they had to bring these books back, and it turns

11 out the books were contaminated. So they had to

12 copy them in a special copying machine, because

13 you had a serious hot records problem both on14 site and off-site.

15 And so these are some interesting -- now

16 they're spending six, seven million dollars on

17 this dose reconstruction. And I'm not suggesting

18 you spend that per site, but I am suggesting that

19 there's a lot to be learned about all of the

20 particular obstacles they stumbled over.

21 Likewise, the work that Dr. Arjun Makhijani

22 did at the Fernald facility, which as been well23 published, and a number of you may be familiar

24 with it, but it would be worth, I think, your

25 all's time to hear about what Dr. Makhijani
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1 encountered where he had access to records you

2 may never see, because he got them compelled

3 through discovery and through the lawsuit for the

4 lawyers that where he was working with. 

5 And you wound up with the documents that

6 showed what the pattern of cover-up was, and what

7 he also learned was that at the Fernald facility,

8 at least with respect to uranium, over half the

9 work force was exposed in excess of the

10 prevailing standard at the time for a decade, and

11 in one year it was 90 percent of the work force,

12 the production work force itself. Pretty

13 startling, and that was based on a urinalysis,

14 post hoc urinalysis. Maybe it would be worth it

15 to hear from him.

16 And likewise, whether it's worth it or not

17 -- and I don't want to step on politically

18 sensitive turf -- but Mark Griffon's research,

19 and the work that he went through at Paducah

20 where he took the electronic record and decided

21 should we just accept the paper record of dose,

22 external and internal, and what happened when you

23 dove underneath the surface of that paper record

24 and what did you find. 

25 In other words, when given -- I don't know
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1 how much money they got; six, eight hundred

2 thousand, a million bucks between them and the

3 University of Utah to do the deep dive with lots

4 of resources and lots of staff, what did you

5 discover? And are there questions and methods

6 that need to be looked at, because I think the

7 task of the contractor here is as much forensic

8 as it is scientific.

9 Lastly, I would pass around, mostly for

10 amusement value, a photograph. This particular

11 photograph is appearing in a copy of The Bulletin

12 of Atomic Scientists, and I'll give you a copy of

13 the magazine for your record. This is a picture

14 of an individual who is stamping a uranium derby,

15 and he is straddling the uranium derby between

16 his legs. His dosimetry badge, however, is

17 pinned to his lapel, nowhere near his gonads. 

18 And the question is, when you were -- when

19 the discussion occurred this morning about, well,

20 we're going to make all these assumptions about

21 how effectively these dose badges are capturing

22 it, and we're going to have some uncertainty bars

23 around it, and we're going to look at the

24 geometric -- what's the relationship of

25 whatever's being emitted to the body, lo and
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1 behold, this is not capturing that dose, or not

2 very much of it.

3 And so the question becomes how are you

4 going to account for what few workers would ever

5 bother to tell you, which is that they straddled

6 uranium derbies? And then how are you going to

7 go estimate that dose thereafter?

8 And so the real world uncertainties are not

9 just simply giving the benefit of the doubt. The

10 real world uncertainties have to be accounted for

11 because you have to overcome all of this. This

12 is nothing -- that reality is in no way captured

13 or reflected in the methods that are given in the

14 guidance, that I've been able to perceive. 

15 And does the uncertainty, the 95 percent

16 error bars around your dose estimate, does that

17 capture that or not? Does that fall outside of

18 those kinds of everyday work experiences? And if

19 it doesn't, then what are you going to do if it's

20 not captured? What are you going to do to

21 account for that? How are you going to account

22 for that?

23 Lastly, it's hard -- at least from the

24 outside, as an outsider, just sort of reading

25 documents and listening to the discussion -- to
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1 figure out how your proposed dose reconstruction

2 rule fits in with the special cohort

3 determinations. And the dovetail is I don't know

4 how you cannot fit the two together. I don't

5 know how you can deliberate on this rule and not

6 look at that policy or rule or whatever it's

7 going to be down the road.

8 How are you going to determine whether it's

9 feasible to estimate dose with sufficient

10 accuracy? That's the policy question, coupled

11 with whether people may have been endangered, to

12 put someone in a special cohort. What in this

13 process that we see here would lead you to the

14 conclusion that it's not or it is feasible to

15 estimate dose with sufficient accuracy?

16 And where is the continuum between the dose

17 estimation process and falling off the cliff by

18 saying, eh, it ain't feasible here? And that is,

19 is the decision, well, we'll toss the claim

20 because we don't have enough information, or is

21 it we'll send them down to the petitioning

22 process? And it would be helpful to see how

23 these fit together to know whether there's a

24 seamless web of coverage for a potential

25 claimant. And I would encourage you all to think
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1 about grouping those together before you give

2 recommendations on whether this is the

3 appropriate approach.

4 DR. ZIEMER: Okay. Thank you for those

5 thought-provoking comments. 

6 Let me ask if there are any questions here

7 that the Board may have. Yes, Roy.

8 DR. DeHART: Mr. Miller, I'm curious, how

9 are we to handle the unknown? How are we to

10 handle that which we don't know, which perhaps no

11 one knows? Or the unusual events, such as the

12 photograph that you show, in dealing with this

13 situation? Should all become special cohort?

14 MR. MILLER: Well, I think that -- I'm going

15 to turn the question around just for the moment,

16 and maybe it would be useful for the committee to

17 get a good grounding in the degree and scope of

18 irregularity in the way in which radiation

19 protection programs have been historically run,

20 at least as DOE has done its own self21 assessments. And I would only -- this is not to

22 not answer your question, but to say should you

23 presume regularity in the sense -- in the paper

24 record that NIOSH will receive? 

25 My answer to that is that I don't think you
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1 should presume regularity. And then I think your

2 inquiry that follows, which I don't know that can

3 be -- there's sort of a couple of ways to do it.

4 One is to look at the problem collectively. Can

5 we get enough information on the history of the

6 radiation protection programs at these sites?

7 And in Hanford, in the cases of many

8 subparts of the various sites, or the big ones,

9 Los Alamos and of course Oak Ridge, you're going

10 to have to subgroup how effective were these

11 programs in each of these different areas. And

12 then once you have some larger sense about

13 whether there's regularity, whether the sort of

14 radiation assessment procedures, as we understand

15 them, were followed, then you can say okay, at X16 10 they had a great program for assessing

17 internal dose, and we have a high degree in

18 confidence that the methods they followed were

19 the best, and we know how to correct for them

20 even. And you may find that at other facilities

21 you can't presume that regularity. 

22 Then the issue becomes what do you do with

23 the special cohorts? I think in the special

24 cohorts you've got a group, the people you know

25 that were at the greatest risk, take the high
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1 risk occupations, and you match them up in some

2 sort of what I would consider to be crude

3 assessment of who falls in and who doesn't,

4 because you're always going to have somebody

5 complaining right at the margin they didn't get

6 in, right? But you're going to have to sort of

7 come up with a box that says these are the people

8 that were really at risk, and assign in a sense a

9 collective risk criteria because we can't pin it

10 down for them. Which is what Congress did with

11 the special cohorts for the facilities it

12 covered.

13 I think that this is a real challenge. This

14 was the compromise. You're asking the question

15 about what was the compromise. I happened to be

16 in the room -- privileged, in fact, to work for

17 the union that represented a lot of nuclear

18 workers in the complex. And if I'm not speaking

19 out of turn here, I'll sort of relay the debate

20 that took place in Congress that punted this

21 issue to you all to grapple with.

22 First there was legislation that was filed

23 that said, look, let's treat people like they're

24 treated in RECA and just presume. And people

25 said, look, we can't throw out sound science.
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1 You're right. So we said, let's apply sound

2 science where it exists, and where it doesn't and

3 there's really good reason to believe that people

4 may have been put in harm's way and there's

5 irregularities, you shift them to the special

6 cohort. 

7 And so the debate was between those that

8 wanted to just do it, just provide the broad

9 special cohorts, and those who just simply wanted

10 to use a dose concept. And the lesson actually

11 came out of the Veteran's Administration program,

12 which said wait a minute, the dose estimation is

13 -- there's so little data upon which to do good

14 dose estimation that where you can't come up with

15 good dose estimates you've got to give people the

16 benefit of the doubt, right? And I think that's

17 really where you need to come down at the end of

18 the day. 

19 Otherwise, what's going to happen is as your

20 dose reconstruction estimates come out and you

21 have -- and this will only -- sort of hindsight's

22 the only way to know this -- but as you have lots

23 of these coming out, and they'll come before your

24 committee and you start looking at these cases,

25 and you're saying people you think should qualify
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1 aren't qualifying, what are you going to do,

2 right? Then it's going to sort of dawn on you,

3 wait a minute.

4 So my recommendation is the most thoughtful

5 way out of this box is to -- and perhaps -- is to

6 get the best histories of radiation protection

7 programs put together in the most critical way

8 possible, as was done for the three GDPs, because

9 it is a road map to what you can rely on and

10 can't rely on on a building-by-building-by11 building basis. It's enormously illuminating to

12 look at that. And then you can decide from

13 looking at this, they did an okay job with the

14 folks in this part, but they didn't here. So we

15 can narrow that cohort, perhaps, to those that

16 were put in harm's way but weren’t properly

17 monitored, weren't told.

18 One thing we do know -- and it really is an

19 ethical question -- if you're going to put people

20 in harm's way and you're not going to tell them,

21 as this memo made a very conscious decision --

22 and this was not isolated to Paducah, and this

23 was not freelancers in the DOE complex. This was

24 the official government policy, as was uncovered

25 at site after site after site after site in the
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1 DOE complex. We have a stack of documents that

2 look like this going back. 

3 Why? Well, because the government didn't

4 want -- the insurance division of the Atomic

5 Energy Commission didn't want to deal with claims

6 and the costs. They were concerned about adverse

7 publicity. They were concerned about demands by

8 unions for hazardous duty pay. They were

9 concerned about trial lawyers suing them. And

10 they were also worried about the consequences

11 that if this wound up in court you could lose

12 classified materials, or classification, rather.

13 So those were all -- so when you're dealing

14 -- my perception of this is that when you're

15 dealing with evaluating how to estimate dose, you

16 have to view it through the historical lens

17 through which it was done, and the notion that

18 this is remedial legislation that was intended

19 to, in a sense, cure cover-ups. 

20 That's a long-winded answer.

21 DR. ZIEMER: Additional questions or

22 comments?

23 MR. MILLER: If I could --

24 DR. ZIEMER: Thank you very much.

25 MR. MILLER: Just with your indulgence, and
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1 because I just came across my one last point I

2 just wanted to re-underscore from last week.

3 Larry, today, Larry Elliott, I think we were

4 discussing sort of the contracting process. And

5 I think it was you who responded to a question

6 from Dr. Melius about, well, how are you going to

7 deal with conflict of interest? And you said,

8 well, we're going to have a conflict of interest

9 plan that we'll negotiate with the contractor

10 after we select somebody. Is that a sort of a

11 roughly fair characterization, based on the RFP

12 language?

13 MR. ELLIOTT: Yes, there's -- the RFP calls

14 for a conflict of interest plan to be submitted

15 along with the proposal. That's part of the

16 evaluation of each proposal.

17 MR. MILLER: Right. Because we don't know

18 what the minimum criteria are for your conflict

19 of interest review, other than what was stated in

20 the RFP, I just want to re-underscore, because by

21 the time we all meet you may have selected the

22 contractor, at the end of March, I guess, right?

23 Is that -- you’re planning on meeting by the end

24 of March, is that right? Advisory Board?

25 MR. ELLIOTT: Tentatively the next meeting
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1 is set for the 25th of March, yes.

2 MR. MILLER: Do you have a rough estimate of

3 when you think the contract's going to be awarded

4 for dose reconstruction, rough time frame?

5 MR. ELLIOTT: It depends upon the number of

6 proposals we receive and the complexity of those

7 proposals that we have to review, and March could

8 be the earliest. I can't really predict at this

9 time.

10 MR. MILLER: Okay. Well, I'd just conclude

11 by sort of wanting to revisit one point, which is

12 that I think that transparency is one of the few

13 things that can build public confidence. And to

14 the extent that this question of transparency

15 with respect to conflict of interest can be

16 addressed in whatever plan that NIOSH comes forth

17 with for its contractors would be very valuable. 

18 If the bidders don't propose it, I guess is

19 my point, to assure transparency, meaning that

20 the individual claimant knows who's

21 reconstructing their dose and what their work

22 history is and their corporation's work history

23 with any given site or claim, if they don't know

24 it's hard to have a lot of confidence in knowing

25 who's on the other side, because at least the
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1 character -- at least two of the three bidders

2 that I understand are going to be submitting

3 bids. 

4 And to that extent transparency, I think, is

5 sort of one of the things you all can impose

6 that's not stated explicitly in your RFP, but I

7 think would raise comfort levels so that people

8 know who's doing the work on the other side. 

9 I think that's it.

10 DR. ZIEMER: Thank you. 

11 Are there any other members of the public

12 who have comments? I just had the two had signed

13 up, but certainly offer the opportunity if

14 there's others that wish to comment.

15 (No response)

16 DR. ZIEMER: Let me ask if there are any

17 other members of the public who have come in this

18 afternoon who were not here when we had

19 introductions this morning, so we know who you

20 are for the record and who you represent. Anyone

21 that did not get introduced? 

22 Actually Bob, you were one of those, but

23 you've now been introduced; Bob Alvarez. 

24 Anyone else?

25 MR. MORAN: I'm Frank Moran from Westat
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1 Company in Rockville, Maryland.

2 DR. ZIEMER: Others?

3 (No response)

4 DR. ZIEMER: Thank you. 

5 Since we're a bit ahead of schedule, I think

6 in the interest of time we are going to proceed

7 with some of the materials that we would have

8 started with tomorrow morning, particularly

9 looking at the proposed rule 42 CFR 82. We, the

10 Board, has to deal with this proposed rule-making

11 in a manner analogous to what we did on 42 Part

12 81 -- that is, we are asked to review the rule

13 and comment, comment specifically on three

14 questions that are in the preamble to this rule.

15 In order to expedite that process, I suggest

16 that we proceed at this point in a fashion

17 similar to what we did at our last meeting, and

18 that is to go through that rule section by

19 section and see if there are questions for the

20 staff or comments that people wish to make. And

21 we'll go through the rule, and then we can

22 prepare ourselves for considering how to address

23 the three questions that are posed for us. 

24 Is that agreeable, then, that we proceed in

25 that fashion?
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1 (No response)

2 DR. ZIEMER: Okay, let's turn to the rule

3 itself. Page 50978 is the introductory material

4 that summarizes the rule and calls for public

5 comments. There's background on the following

6 page on statutory authority. There's information

7 on the legal requirements for dose

8 reconstruction, information on the purpose of

9 dose reconstruction, an explanation of how doses

10 are reconstructed, how they are conducted, and so

11 forth. The actual rule -- and then a history of

12 the rule development.

13 The actual rule begins -- I'm looking for

14 the page, the actual beginning here, just a

15 moment -- 50985. And of course at the very

16 beginning there's kind of an index to the various

17 sections, starting with Section 82.0 and so on.

18 So let us then begin with page 50986, and

19 we'll look at this section by section. We're not

20 going to read the sections, but we will pause at

21 each one, assuming the Board members have read

22 this again and again for their evening pleasure.

23 Section 82.0, any question on the background

24 information, or comments?

25 (No response)
224 

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1 DR. ZIEMER: I'll push us along here on some

2 of these questions if it's clear that there are

3 no comments.

4 82.1, purpose of the rule?

5 (No response)

6 DR. ZIEMER: 82.2, basics of dose

7 reconstruction? Roy.

8 DR. DeHART: I have a question under item

9 (a) of that. It says specifically that we are to

10 -- or in constructing the dose reconstruction

11 that the accuracy of the dose that has been

12 calculated -- and all of that information that

13 would come in, I assume, from DOE -- the question

14 that was raised by Mr. Miller on the accuracy of

15 that information, could NIOSH comment about how

16 they would attend to address that issue on the

17 accuracy of dose information provided to you?

18 DR. ZIEMER: And it may go beyond accuracy.

19 The dose information may be accurate, but I think

20 one of the questions being raised was does that

21 reflect the actual workplace situation, perhaps

22 was --

23 DR. DeHART: That's what I mean by accuracy.

24 DR. NETON: Yeah. The statement reads, if

25 found to be complete and adequate --
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1 DR. DeHART: Yes.

2 DR. NETON: -- individual worker monitoring

3 data such as dosimeter readings. 

4 That speaks to that issue, which is NIOSH

5 intends to use personnel monitoring data only

6 after a thorough review that the data themselves

7 were -- accurately depicted the exposure

8 environment of the worker themselves. And that

9 would require an analysis of the type of

10 materials that were in the workplace, the

11 energies of the emissions for the dosimeters, and

12 the adequacy of the bioassay monitoring program

13 to measure the workplace exposure elements. 

14 So we would be relying on the process

15 information at the sites, a technical review of

16 the bioassay programs. We know for certain cases

17 bioassay samples were taken but no tracers were

18 used, so one doesn't know whether that represents

19 a ten percent recovery of the material or 95

20 percent. There are some studies out there, so it

21 will be review of those studies that have been

22 published that have evaluated those

23 circumstances.

24 So it would -- it's going to be very

25 facility-specific. But we certainly would not
226 

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1 use the data without first making a determination

2 if it was representative of the worker's

3 exposure.

4 DR. ZIEMER: And can you also comment on the

5 nature of your documentation of that? Would

6 there in each case, then, be some sort of a

7 report or an analysis that you provide?

8 DR. NETON: Yes. It is our intent that we

9 develop a facility profile for the facility that

10 documents such things as the detection limits,

11 the quality of the monitoring programs, that

12 could be used for the individual sites.

13 DR. ZIEMER: And this would be a public

14 document, so that if workers at that site felt

15 that it did not reflect what was going on there

16 would be ample opportunity for that information

17 to emerge?

18 DR. NETON: Yes.

19 DR. ZIEMER: If somebody said, you know, we

20 always straddled these things --

21 DR. NETON: Yeah, that's --

22 DR. ZIEMER: -- or whatever.

23 DR. NETON: That's our intent.

24 DR. ZIEMER: Well, I notice in that picture

25 it appears that the guy is wearing wrist badges,
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1 and those would be very accurate determinations

2 of gonadal dose. That's not an anatomical

3 statement, but more of the -- I mean, I do know

4 my anatomy.

5 (Laughter)

6 DR. ZIEMER: The location of the wrists in

7 that case were similar. But -- I'd better stop.

8 In any event, is there some level of

9 confidence that the process -- I think this is

10 perhaps Roy's question, I don't want to put words

11 in your mouth -- would uncover irregularities

12 that might otherwise not appear.

13 MR. ELLIOTT: Let me add to Jim's response.

14 Yes, we're very aware of many of the reports

15 that Mr. Miller has mentioned, and the dose

16 reconstruction processes underway at like Mound

17 and Rocky Flats. Having those available to us is

18 a benefit. Our interview process, we hope to

19 establish some of these other types of things

20 that are not obviously evident and available in

21 records.

22 How do we try to get at that, beyond that?

23 That is something we're wrestling with. We

24 appreciate anybody's thoughts and suggestions on

25 how to improve in that regard. We feel that as
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1 we go forward and accrete information and create

2 these profiles for a site, not only will that be

3 made public and available for comment, but a

4 report on each individual dose reconstruction

5 will go to the claimant as well as DOL for the

6 adjudication of the claim, and relevant

7 information from that individual dose

8 reconstruction effort in that report will be

9 pulled out and incorporated into the profile as

10 it's built. 

11 So that will become part -- the individual

12 dose reconstruction report for a claimant won't

13 be public information, but the relevant new

14 information gained from that piece of the process

15 will be.

16 DR. ZIEMER: There was also some indication

17 that even the workers themselves may not be aware

18 of irregularities, so we certainly need to be

19 cognizant of other indicators that would suggest

20 that something was amiss, whether it's a mass

21 balance issue or some other sort of indicator.

22 DR. DeHART: Roy DeHart again. 

23 The issue of the employee remembering what

24 their dose is and being able to refer to that on

25 interview, of course, is important, and probably
229 

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1 can only be done correctly if they're given that

2 information. 

3 When it comes to the rule, once the rule

4 becomes final, I can't remember in reading

5 through this whether it allows you the

6 flexibility to adjust and make change. Does it?

7 MR. ELLIOTT: Yes, it does, and as with the

8 IREP – and you wanted to see the significant

9 changes that were made to those -- you would have

10 opportunity to review those. You'll also have

11 opportunity to review significant changes that

12 would occur in dose reconstruction methodology

13 that's in the implementation guidelines or the

14 technical basis documents. 

15 That becomes part of the information we

16 present to you for your understanding and your

17 review of dose reconstructions, as well as your

18 review to comment and say this makes sense, this

19 should be -- this is a change that should happen.

20 Or if you feel conversely, you can express that

21 as well.

22 DR. MELIUS: But just to clarify that point,

23 that is not in the regulation, is it, that

24 review, that process? It's in the preamble

25 again. Do we have the same issue we had with the
230 

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1 other --

2 MR. ELLIOTT: (Nods head)

3 DR. MELIUS: Okay.

4 DR. ZIEMER: Right, and we may want to

5 return to that. 

6 Henry.

7 DR. ANDERSON: Just a somewhat interpretive

8 question. Are you going to have to make for each

9 case a determination that the data is complete

10 and adequate? 

11 I mean, like (a) here is if found to be

12 complete and adequate. That assumes that you

13 make a -- in order to begin, you're going to have

14 to make a determination, which might be from your

15 site-specific or -- what I think we've been

16 seeing through this whole thing is you're going

17 to use all the information you have available,

18 which is quite different from having to make a

19 determination, is it adequate. You could say

20 it's inadequate, but it's the best we have so we

21 will use it. And I just want to be sure you

22 don't get caught subsequently with being

23 challenged that it should not have been

24 considered adequate.

25 DR. NETON: I guess it's an issue of
231 

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1 semantics, but yeah, we will -- we do intend to

2 on an individual basis determine that the

3 information's complete and adequate to conduct a

4 dose reconstruction. Now that does not

5 necessarily mean that we have every shred of

6 available evidence out there. We just have

7 enough of it to be able to complete a dose

8 reconstruction, to make an unbiased determination

9 as to whether or not the person has a significant

10 exposure or not.

11 DR. ANDERSON: Okay.

12 DR. ZIEMER: But the rule does not require

13 that there be adequate dosimetry to do the dose

14 reconstruction.

15 DR. NETON: No.

16 DR. ZIEMER: It only -- it says if it is

17 adequate, you do it from that monitoring data.

18 DR. NETON: Right.

19 DR. ZIEMER: If not, you go to sort of plan

20 B.

21 DR. ANDERSON: To B, yeah. And what we

22 haven't seen is what's the model for plan C. How

23 would you use -- how would you do dose

24 reconstruction based on --

25 DR. NETON: Okay, I think I know where
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1 you're coming from. I covered that --

2 DR. ANDERSON: It's kind of the levels. You

3 go A –

4 DR. NETON: Yeah.

5 DR. ANDERSON: And we really dealt with --

6 we're assuming you're going to have some level A

7 information and we're going to move from there.

8 I'm just curious as to -- C almost gets us into

9 the special --

10 DR. ZIEMER: No, but that’s source term and

11 so on.

12 DR. NETON: Right, yeah. I gave an example

13 last meeting of how we would approach it from a

14 source term analysis based on the amount of

15 material that were there, the types of

16 operations, whether it was grinding, welding,

17 cutting, and to give a bracketing dose estimate

18 for the individual, keeping in mind that we are

19 not constrained to have single point estimates

20 for a person's dose. We can put a distribution,

21 and I think I indicated at that time that may

22 well be a range --

23 DR. ANDERSON: Okay.

24 DR. NETON: -- a uniform range, saying our

25 estimate ranges between one and ten rem. And
233 

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1 that would be a viable input to be able to put

2 into the IREP program.

3 DR. ANDERSON: Okay.

4 MR. ELLIOTT: If I could add a comment here

5 on this topic.

6 The paragraph right before (a), I think,

7 sets us up for this hierarchical approach. And I

8 would add that to advance forward and say the

9 dose reconstruction is complete -- whether it's

10 done by (a), just using the radiation dosimetry

11 data from the site and saying that's enough,

12 because the person's automatically is going to

13 achieve an award; or it's done by (c), through

14 source term and lot more of uncertainty

15 associated with it -- before we advance that

16 forward, we get the claimant to understand what

17 we've done, how we've done it, and seek their

18 agreement to move it forward.

19 DR. MELIUS: Yeah, one comment on that, and

20 then just to move it on to level D, which isn’t

21 there. 

22 I would, as I said before, I think it would

23 be very helpful to get a presentation at some

24 point on how you're going to do sort of A to B to

25 C, particularly how you're going to handle C at
234 

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1 that point.

2 My concern also, though, then extends to D.

3 We're -- D would be where you can't do dose

4 reconstruction because you don't have adequate --

5 it's not clear here. This comes up in a later

6 section also, that what the criteria will be, and

7 that one is where we really get, hit the Special

8 Exposure Cohort. We're going to back into

9 Special Exposure Cohorts, but we don't know what

10 that -- how those will be defined or what the

11 process will be.

12 And it makes it very hard to comment on this

13 section of the proposed rule, and it also makes

14 it very hard to address one of your specific

15 questions, particularly -- I think it's question

16 -- the second question regarding the efficiency

17 of the process. Because I think as you get into

18 this -- go down from A to B to C, you're talking

19 about more and more resources going into the

20 effort.

21 And then we get into this issue of the

22 special incidents or whatever or missing

23 information. Really, you're talking about more

24 and more resources being drawn into this process.

25 And at some point it seems to me it makes sense
235 

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1 to just stop the resource, the effort, and just

2 put people in a Special Exposure Cohort. If you

3 could short-circuit that in some way.

4 And I'm just having trouble looking at this

5 process not knowing what the way out is, and how

6 much we have to -- how much of an effort we have

7 to put into this rule without knowing that. And

8 I understand the bind that you're in also, so --

9 MR. ELLIOTT: You understand the bind we're

10 in? Or do you not understand the bind we're in?

11 I didn't --

12 DR. MELIUS: I don't understand well enough

13 for -- I think you should speak to it.

14 MR. ELLIOTT: It seems to me that I hope --

15 well, I hope that Kim and Marie caught your

16 language, because it seems to me that's some

17 comment the Board might want to consider adding

18 to their remarks about this rule.

19 Would I have liked to have given you the

20 Special Exposure Cohort guidelines to review

21 today in addition to this? Certainly. Am I able

22 to? No. Suffice it to say that if we can't do a

23 dose reconstruction, then we have the ability to

24 say that's a class of workers that need to be

25 added to the Special Exposure Cohort. 
236 

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1 Now that's -- I can't predict that that's

2 what you're going to see in these policy

3 guidelines, but that's the only comment I can

4 make at this point.

5 DR. MELIUS: Yeah. Just to elaborate, I

6 think from looking at it from this rule, this is

7 a continuum, and that's what we're sort of

8 wrestling with to comment on this part of the

9 rule. That has to be the ultimate part of the

10 continuum, and I think we're having -- I

11 certainly have difficulty commenting until I know

12 where that continuum's going.

13 MR. KATZ: Let me -- I'm sorry, Ted Katz

14 here. 

15 Just to add to what Larry said just for

16 clarity in the record, though, it's not only can

17 we not do a dose reconstruction, but is there

18 some evidence there that there were substantial

19 exposures? Because clearly you could have a

20 situation where you can't do a dose

21 reconstruction, but the evidence suggests there

22 weren't substantial exposures, and you wouldn't

23 be adding that to the Special Exposure Cohort.

24 DR. ZIEMER: Yeah, that's understood, I

25 think. Right.
237 

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1 DR. MELIUS: You seem to be defining this

2 differently at different points in time,

3 including in your instructions to the

4 contractors, the bidders. I'll show you later.

5 DR. ZIEMER: Okay. Let me interject here

6 while we're going through this, and just remind

7 the Board of the three questions. So I want to

8 back you up just briefly to 50978, the right-hand

9 column, comments invited. These are questions

10 similar to those that were developed for the Part

11 81 rule-making.

12 Question one: Does the interim rule make

13 appropriate use of current science for conducting

14 dose reconstructions to be used in an

15 occupational illness compensation program?

16 Question two: Does the interim rule

17 appropriately balance the potential precision of

18 dose reconstructions and the necessary efficiency

19 of the dose reconstruction process?

20 Question three: Does the interim rule

21 implement an appropriate process for involving

22 the claimant in the dose reconstruction?

23 I don't believe we're necessarily limited to

24 those three questions, but as a minimum the staff

25 seeks comments along those lines. And those
238 

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1 somewhat parallel the questions we -- not

2 completely, but somewhat parallel what we

3 addressed for the other rule.

4 Now back to section 82.2, are there any

5 further questions or comments on that section?

6 (No responses)

7 DR. ZIEMER: 82.3, What are the requirements

8 for dose reconstruction under E-E-O-I-C-P -- how

9 do you pronounce that acronym again?

10 MS. MURRAY: EEOICPA.

11 DR. ZIEMER: The court recorder knows how to

12 pronounce it. She's the only one that does,

13 because she's saying it into her mike there.

14 Anyway, any questions on that section?

15 (No responses)

16 DR. ZIEMER: 82.4, How will Department of

17 Labor use the results?

18 (No responses)

19 DR. ZIEMER: Subpart B, Definitions. No

20 questions or comments?

21 (No responses)

22 DR. ZIEMER: Subpart C, the Dose

23 Reconstruction Process; 82.10, Overview of the

24 dose reconstruction process. 

25 (No responses)
239 

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1 DR. ZIEMER: Paragraph (a)?

2 (No response)

3 DR. ZIEMER: (b)?

4 (No response)

5 DR. ZIEMER: (c), concerning interviews?

6 (No response)

7 DR. ZIEMER: (d), the NIOSH report

8 summarizing its findings?

9 (No response)

10 DR. ZIEMER: (e), concerning the use of

11 information provided by the claimant?

12 (No response)

13 DR. ZIEMER: (f), concerning the

14 confirmation of claimant's information?

15 (No response)

16 DR. ZIEMER: (g), request of additional

17 records from DOE?

18 (No response)

19 DR. ZIEMER: (h), NIOSH review of adequacy

20 of -- and completeness of records provided by

21 DOE? To some extent relates to what we've been

22 discussing here.

23 I have one question on that section. There

24 is a requirement that the Department of Energy

25 certify that record searches have been completed.
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1 Is that a simple statement, yes, we've completed

2 the records searches, or what is that

3 certification?

4 DR. NETON: Yeah, that's the intent, that

5 they provide some written confirmation that they

6 have searched their records and have completed

7 it.

8 DR. ZIEMER: Do you ask them to spell out

9 the extent of that search, where did you look?

10 DR. NETON: We direct them to search in

11 certain locations for different types of records,

12 and they would be confirming that they have

13 searched throughout all those archives or

14 inventory of types of records. 

15 However, we do intend -- I think somewhere

16 in the rule it specifies that we -- I'm pretty

17 sure it's in here, that we will actually visit

18 certain sites and to confirm, to do sort of a

19 quality control check, if you will, that all

20 available records have been brought forward for

21 that site. So there will be some site visits

22 conducted by NIOSH to help confirm that as well.

23 I don't recall exactly in the rule where that is,

24 but I'm pretty sure we've committed to that.

25 DR. ZIEMER: Other questions on (h)?
241 

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1 DR. ANDERSON: Just a question that came up

2 with an example over lunch, and Department of

3 Labor will make a determination that they were in

4 fact employed at a facility. And the question I

5 have is there may well be, for instance, even

6 internal NIOSH studies that have been done that

7 will have some industrial hygiene or personal

8 badge measurement data, that it's possible the

9 records of employment may have been lost and DOL

10 will up front say, no, we have no record that you

11 were ever employed there; yet searching through

12 somebody else's database you might find that in

13 fact the name appears, that he was interviewed in

14 XYZ study. 

15 That's probably a DOL issue. But it would

16 seem to me there may well be some university and

17 research records, that somehow you may want to

18 try to inventory to see if there are lists of who

19 participated in what studies that people might

20 otherwise be lost in the official system, but

21 through other studies would have some indication

22 that they in fact worked there.

23 MR. ELLIOTT: It's a -- your point's well

24 taken with us. It is a Labor, Department of

25 Labor requirement, issue; and they have other
242 

NANCY LEE & ASSOCIATES

1 mechanisms that they're employing -- Social

2 Security account or Administration files,

3 Internal Revenue approach toward verifying

4 employment -- beyond DOE saying we can't seem to

5 find a record for this person.

6 DR. ZIEMER: Aside from the employment

7 records, has the staff considered, as far as

8 characterizing the workplace, independent

9 records?

10 For example, records that might be under the

11 purview of state regulatory agencies such as the

12 New York Department of whatever they call it

13 there, the radiation safety folks, or Illinois

14 Department of Nuclear Safety, those folks that

15 might have monitoring records for sites. I'm not

16 referring to the DOE contractor labs per se,

17 because there's no jurisdiction there. But some

18 of the other sites that we might be talking

19 about, the atomic workers and other contractors

20 who might have worked under licenses, and are --

21 at that time AEC licenses, either old AEC

22 records, which now are sort of -- who has those,

23 NRC or DOE?

24 DR. NETON: NRC, I believe, would have those

25 records.
243 

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1 DR. ZIEMER: And other union records --

2 DR. NETON: Right.

3 DR. ZIEMER: -- what about those?

4 DR. NETON: We've considered that approach.

5 In fact, one of our near-term visits will

6 probably be the Nuclear Regulatory Commission to

7 look through, in particular, as you mentioned,

8 for the atomic weapons employers. A license

9 itself will go a long way to establishing the

10 source term. 

11 To the extent they have monitoring records,

12 that would be great, although it's my

13 understanding of historical AEC licenses, they

14 typically did not require the monitoring results

15 to be sent to them or held by them. That's my

16 understanding. I'm not saying that's in all

17 cases. But we're certainly going to look through

18 the different avenues, the Nuclear Regulatory

19 Commission, AEC, precursor of the NRC.

20 DR. ZIEMER: Thank you. 

21 See where we are here; (i), yes.

22 DR. ANDERSON: We probably covered this a

23 little earlier, but it talks about may use

24 default values if there's no process for how your

25 -- it gives some examples here and says what they
244 

NANCY LEE & ASSOCIATES

1 ought to be, but no method as to how you would go

2 about developing those. Or are there existing

3 default values that you --

4 DR. ZIEMER: Is it safe to assume that that

5 would appear in the guidelines rather than in the

6 rule-making?

7 DR. NETON: Yes, that's correct. And I

8 think the example we talked about earlier is the

9 five micron particle size for ICRP 66, that sort

10 of thing. I'm not sure that we want to commit to

11 the exact default values in the regulation

12 itself.

13 DR. ANDERSON: I just -- it ought to --

14 sometime you're going to have to -- and we ought

15 to --

16 DR. NETON: Get off the fence, yeah.

17 DR. ANDERSON: -- discuss it here, I guess

18 is what I'm saying, at some future meeting. It's

19 probably worth looking at what's out there, what

20 might be appropriate, and us to be able to

21 comment to you on it before you get into having

22 used it and then have it subsequently challenged.

23 DR. NETON: Certainly.

24 DR. ZIEMER: Item (j), dealing with

25 incomplete records?
245 

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1 (No response)

2 DR. ZIEMER: Item (k)?

3 DR. ANDERSON: Paul?

4 DR. ZIEMER: Yes.

5 DR. ANDERSON: Just a word that I look for

6 in our state things, is under (j) you have once

7 the resulting data set has been evaluated and

8 validated.

9 Validation tends to be a real difficult

10 thing to do. So I guess the question would be

11 how -- what would you view as validation versus -

12 - you could certainly evaluate it quite easily,

13 but validating measurements, it's pretty tough,

14 especially old -- unless you're going to review

15 the QA/QC program in place at the time. What is

16 your intent here, just -- you may want to look at

17 that word, because it carries a great deal of

18 time and effort.

19 DR. NETON: I've developed a new

20 appreciation for the meaning of the word

21 “validated” in the last several months, I'll

22 agree with that. 

23 The intent here was to evaluate it, and to

24 validate it in the sense that it accurately

25 depicts the exposure situation, is the intent of
246 

NANCY LEE & ASSOCIATES

1 that word. Now whether that has special legal

2 meaning beyond that, I guess we'll leave to our

3 legal counsel.

4 DR. ZIEMER: Okay, let's move on to Item

5 (k), which has a lot of subparts to it, goes

6 through a step-wise procedure.

7 (No response)

8 DR. ZIEMER: Item (l), which deals with the

9 draft dose reconstruction for a claimant?

10 MS. GADOLA: I have a question about the

11 compiling of all of this that would fit in with

12 (k) and (l). 

13 If, while you're collecting all of the

14 information, if it becomes apparent that there

15 are certain types of cancer that seems to be

16 turning up in certain jobs -- example, if there

17 seems to be a lot of bladder cancer, and it's

18 found in one particular job at four sites, and

19 then there's two other sites where it's extremely

20 low, would this type of information be utilized

21 in determining the validity of maybe the two

22 sites where it's very low? Anybody?

23 DR. ZIEMER: Okay, who wishes to answer

24 that? I think that's a question for the staff.

25 DR. NETON: I guess I'm not sure of the
247 

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1 thrust of the question. The validity of the dose

2 reconstructions, or is it would be advisable for

3 us to turn that over to someone for future

4 epidemiologic research possibly? I'm not --

5 MS. GADOLA: Probably both. 

6 DR. NETON: Yeah.

7 MS. GADOLA: I could see where you could do

8 it in the future, but like it would -- it seems

9 like it would cause you to question the validity

10 if you seem like you have a high percentage at

11 the majority of sites for this particular job,

12 and then at two sites it seems extremely low.

13 Would it give you more reason to question the

14 dose reconstruction at these two other sites?

15 DR. NETON: I'm not sure. There are a

16 multitude of other exposure agents that we're not

17 evaluating in the dose reconstruction process,

18 particularly the chemicals, exposure to asbestos,

19 that sort of thing. So it would be of scientific

20 interest, but I'm not sure how we would

21 incorporate that into our program of dose

22 reconstruction.

23 MR. ELLIOTT: Well, I understand your

24 question better now, I think. And my response to

25 you would be that -- and I think we've talked
248 

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1 about this among team discussions we've had --

2 that we would look for those kind of anomalies,

3 where we seem to do dose reconstruction for one

4 site for one type of cancer that seems to result

5 in a propensity for award, and all of a sudden at

6 another site where you've got the same cancer,

7 but we don't see, you know.

8 MS. GADOLA: Uh-huh.

9 MR. ELLIOTT: So what's going on? Is it the

10 dose?

11 MS. GADOLA: Right.

12 MR. ELLIOTT: Okay, maybe it is the dose.

13 Maybe this site has distinct internal dose that

14 contributes to that and this other site doesn't.

15 That may be something that the Board wants to

16 take up in its evaluation of dose reconstructions

17 as a way to set your sampling strategy on what

18 you review.

19 MS. GADOLA: It does bring up several other

20 questions, and it also reminds us of the amount

21 of data that will be collected during this whole

22 process. And hopefully it can be used in the

23 long term to really give us a better idea of

24 actually what did happen with these people, and

25 what is going to be happening to other people
249 

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1 that might be working in similar situations.

2 DR. ZIEMER: Jim.

3 DR. MELIUS: Yeah. I think following up on

4 that more from, say, the exposure information

5 side, I don't think you've really presented to us

6 how you're going to maintain the data and so

7 forth, and I think we would be interested at a

8 future meeting in hearing about that. 

9 But there would be, I think, situations

10 where you're going to learn more about a site or

11 a particular process at a site two years down the

12 road than you know now, so that could possibly

13 change the dose reconstruction for a particular

14 individual who came through earlier. We'd hope

15 it wouldn't be common occurrence, but it might

16 occur. And I think that would be -- I think it's

17 important that there be a data system in place

18 that would allow you to use your past experience,

19 and also, if it is necessary, correct any past

20 errors in reconstructing dose. 

21 So I'm assuming you're doing that, but I

22 would be interested in hearing more about it at a

23 later meeting.

24 MR. ELLIOTT: We plan to do that, and we've

25 talked with Labor about a feedback loop. When we
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1 experience a change in the way we do a dose

2 reconstruction and looking at those claims that

3 went before that, and which of those did not

4 receive an award and reevaluating those under the

5 new dose reconstruction change. And I've noted

6 that you do want a presentation on more on our

7 statistics that we collect and how we monitor and

8 track the claims.

9 DR. DeHART: Rather than dose

10 reconstruction, might this not actually represent

11 a change in the risk for that cancer, which goes

12 back into the computerized program, not the dose?

13 Because here, as has already been suggested, you

14 may be dealing with something entirely different

15 from radiation.

16 DR. ZIEMER: Can I partially respond to

17 that, Roy? 

18 I don't think NIOSH is going to be in a

19 position to be adjusting risk values because

20 you're using -- that data could become available

21 to -- for the database for those who are --

22 you're using NCI risk values, I believe. Is that

23 not correct?

24 DR. NETON: Well, it's a combination of --

25 so to a large extent we are. But there are
251 

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1 several models that the NCI did not include that

2 we needed, such as a bone cancer model that is

3 included in the NIOSH/IREP. 

4 But I would caution the usability of our

5 data for epidemiologic risk modeling, because we

6 are only carrying the dose reconstruction far

7 enough, because of the large volume of cases, to

8 get an answer. If a person falls low or high, it

9 will not necessarily be the exact dose to that

10 person's organ. So the ones that are carried

11 full through the process, of course, would be

12 useable. And the information that Tim provided

13 where we're correcting for a lot of these other

14 exposure scenarios, I have never seen that extent

15 done on an epidemiologic study to really -- to

16 try to determine what the actual organ dose is

17 versus what the badge result is. And there are,

18 as Tim pointed out very well, very distinct

19 differences.

20 DR. ZIEMER: I'm going to exercise the

21 Chair's prerogative and declare a comfort break

22 of approximately ten minutes, then we'll

23 reconvene.

24 (Whereupon, a recess was taken from

25 4:05 to 4:16 p.m.)
252 

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1 - - -

2 DR. ZIEMER: Continuing our review now of

3 the proposed rule-making, we're at subsection (l)

4 on page 50988. Any questions on that section?

5 (No response)

6 DR. ZIEMER: Section (m)?

7 (No response)

8 DR. ZIEMER: Then section (n), concerning

9 the NIOSH report to DOL?

10 DR. ANDERSON: Just a question.

11 DR. ZIEMER: Henry.

12 DR. ANDERSON: Are you anticipating that

13 under (m) there there'll be a back and forth?

14 Because I can see a 60-day time line for a next

15 of kin who's trying to generate the information

16 you need, they may run into that. So is the --

17 MR. ELLIOTT: Yes.

18 DR. ANDERSON: -- to send a form back,

19 they're not going to be -- you have to have a

20 time line at some point, but when will the ticket

21 start to run? So under the first one, it'll be

22 back and forth, and then you'll finally say,

23 well, we think we have -- we haven't heard from

24 you in a while. Here's the form you have to sign

25 saying you're finished.
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1 MR. ELLIOTT: Well, as (m) says, we have --

2 before we would forward the report on to DOL for

3 final adjudication of the claim, we have to have

4 the claimant's agreement to do that in OCAS-1.

5 DR. ANDERSON: Okay.

6 MR. ELLIOTT: So we're not going to forward

7 that until we get that. So if we send that -- we

8 had the conversation with the claimant about the

9 final dose reconstruction draft report and we ask

10 them to sign OCAS-1, and they say let me think

11 about all this and get back to you, we're going

12 to follow up with them.

13 DR. ANDERSON: Okay.

14 MR. ELLIOTT: We can't go forward with it

15 until we have their consent to do so.

16 DR. MELIUS: Shouldn't that be more

17 explicit, then? Because that's not the way I

18 read this, was that the fact -- I guess what I'm

19 concerned about is what Henry was saying, is that

20 the person that's trying to provide you with more

21 information, they’re next of kin, they're having

22 trouble getting that information. They may have

23 requested it, some additional information they

24 don't think you got from DOE or whatever. And

25 what you're saying is that they're really going
254 

NANCY LEE & ASSOCIATES

1 back, they haven't really done the final

2 interview –

3 MR. ELLIOTT: Yeah, we're not done with them

4 at that point, then.

5 DR. MELIUS: Yeah.

6 MR. ELLIOTT: We're not -- at that point --

7 I misunderstood your comment. At that point

8 we're not saying sign the OCAS-1 form. We're not

9 trying to force them to do that. We'll still be

10 waiting there for them to produce that

11 information.

12 DR. NETON: It says may administratively

13 close the claim. It's not an automatic. 

14 I think the intent was to cover situations -

15 - correct me if I'm wrong, Ted -- but a claimant

16 who would just refuse to sign the OCAS-1 form.

17 But I -- they're not signing they agree with the

18 dose assessment, dose reconstruction itself.

19 They're actually signing that we have put forward

20 all of the information that they provided us, and

21 it's included in their claim. 

22 Now we may have at some point chose not to

23 use their information for whatever reason, and

24 they can disagree with that. But when they sign

25 the OCAS-1 they're not saying that they agree
255 

NANCY LEE & ASSOCIATES

1 with the actual dose estimate itself. But if a

2 person says I'm not going to sign it, then we

3 have to have some outlet to close the record.

4 DR. MELIUS: Yeah, but wouldn't that then be

5 -- answer this question. Would there be then a

6 notification -- see, up until this point it's

7 sort of an open-ended, back-and-forth process.

8 Now you're suddenly cut him off. I would presume

9 that there would be a notification to them, a

10 formal notification saying, look, we think we've

11 gone as far as we can, blah, blah, blah. Here's

12 the form. We're giving you 60 days. If not,

13 then you have -- we're going to close out the

14 claim.

15 DR. NETON: I think that was the intent. Is

16 it in there?

17 DR. MELIUS: Is that -- okay.

18 MR. KATZ: Sixty days.

19 DR. MELIUS: I know that 60 days is in

20 there, but it wasn't clear to me where the

21 process stopped being interactive, and where

22 you're cutting it off.

23 MR. ELLIOTT: I think what you're asking,

24 what you're getting at, is do we go back to the

25 claimant with some final correspondence --
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1 DR. MELIUS: Yeah.

2 MR. ELLIOTT: -- saying, okay, we've chosen

3 to exercise our right to administratively close

4 the file --

5 DR. MELIUS: Right.

6 MR. ELLIOTT: -- and move the dose

7 reconstruction report forward for final

8 adjudication.

9 DR. MELIUS: Uh-huh.

10 MR. ELLIOTT: And I would -- I don't know if

11 my lawyers are here, but I would think they would

12 weigh in on that and say yeah, we need to have

13 something like that to make that step happen.

14 MR. KATZ: Yeah, I mean at the point where

15 we realize -- or it appears that we have a

16 claimant that's simply not going to sign is when

17 we would notify them formally that they have 60

18 days, upon which we will then go ahead and close

19 the claim. So then they would have an additional

20 60 days, in effect, to make a decision to sign

21 the form and let it go forward or not.

22 DR. MELIUS: I think what's not captured in

23 all of these going back is that it's sort of a

24 back-and-forth process. It sort of looks

25 sequential here, and it's really not because --
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1 or may not be, that there's -- this information

2 goes. And that gets a little bit confusing.

3 It's hard to write the regulations, I think, to

4 capture the back and forth that goes on, but I

5 think it is important. Maybe it's in the

6 preamble and I missed it, but --

7 DR. ANDERSON: Yeah, it seems to me in (l)

8 you provide them with a draft of the dose

9 reconstruction. And what I was concerned is you

10 say here it is, you have 60 days to come up with

11 additional information or not; as opposed to we

12 all agree that we have -- you've done the best

13 you can, and now we want to ask you, we need to

14 have your permission to move it forward, and

15 here's the paper that gives the permission,

16 versus you telling them we're done. You either

17 generate something more in 60 days, or it's

18 finished. 

19 And that puts the pressure potentially on

20 them to generate data, as opposed to they're

21 saying here's the draft, we're still looking for

22 Uncle Joey. We know he's around somewhere, but

23 we think he's out elk hunting and hasn't come

24 back, and we'll never find him in 60 days.

25 MR. ELLIOTT: It appears to me from this
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NANCY LEE & ASSOCIATES

1 discussion we need to make this very clear, what

2 our intent is here for you, and for the claimant.

3 DR. MELIUS: Yeah, I think maybe the way to

4 clarify it is that there are two situations. One

5 is where it's a good claim, you just need to move

6 it forward. Second one is where it's really --

7 the dose reconstruction hasn't shown that they

8 have sufficient exposure to warrant the claim,

9 then I think that's where you're going to get

10 into this process. And I think maybe clarifying

11 that in the regulation would be helpful. 

12 And I'd almost rather give a little bit more

13 than 60 days, but at some point it depends on how

14 open the previous prior process is. Because I

15 really think there's going to be situations where

16 a next of kin or something is really going to be

17 struggling to try to find someone who knows

18 something that they -- they remember their father

19 telling them something about the plant, and

20 they're trying to find somebody to corroborate

21 that or whatever, and I think that could be a

22 hard process. I think giving them some more time

23 may be better, again, but it shouldn't go on.

24 You shouldn't have to keep the claim open

25 forever, either.
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NANCY LEE & ASSOCIATES

1 DR. ZIEMER: The wording here sounds to me

2 to be one in which the claim is not automatically

3 closed after 60 days. It says they may close it,

4 not that they must close it. Is that

5 intentional? And likewise for Department of

6 Labor, they may then close the claim, but it

7 doesn't appear to be mandatory. It seems to be

8 discretionary. They may close the claim.

9 DR. ANDERSON: Well, (o) says shall be

10 closed --

11 THE COURT REPORTER: Use your microphone,

12 please.

13 DR. ANDERSON: -- unless reopened.

14 UNIDENTIFIED SPEAKER: Microphone.

15 DR. ANDERSON: Yeah, (o) says it shall be

16 closed unless reopened. That's the next item.

17 DR. ZIEMER: But that's once the actions in

18 the previous thing are done. Once they do --

19 DR. ANDERSON: Yeah.

20 DR. ZIEMER: But it doesn't appear that

21 they're required to exercise that prerogative

22 under part (m) or (n), but if they do, then it

23 becomes mandatory. Am I reading that right?

24 MR. ELLIOTT: Yes, I think you have the

25 right sense of that, what we intended it to be.
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NANCY LEE & ASSOCIATES

1 DR. ZIEMER: Wanda, please.

2 MS. MUNN: And in any case, (o) clearly says

3 it still may be reopened. It isn't as though

4 this falls off the end of the earth. There's --

5 if we find Uncle Joe, surely we can come back and

6 the Department of Labor will accept that

7 information.

8 DR. ZIEMER: Thank you. 

9 Other comments? 

10 (No responses)

11 DR. ZIEMER: Section 82.11?

12 DR. DeHART: A point of clarification.

13 DR. ZIEMER: On this section or previous?

14 DR. DeHART: On 82.11.

15 DR. ZIEMER: 82.11, okay.

16 DR. DeHART: If for efficiency we have used

17 a high dose and we see that the claimant has had

18 an experience where it would be awardable, is

19 that considered at that time a reconstruction of

20 the dose? Because it says here you will do a

21 dose reconstruction on every claimant.

22 DR. NETON: That's correct, that would be

23 considered a dose reconstruction.

24 DR. ZIEMER: Okay. Further questions on

25 that section? 
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NANCY LEE & ASSOCIATES

1 DR. NETON: It would fall for consideration

2 under the Special Exposure Cohort guidelines,

3 that's correct.

4 DR. ROESSLER: Yeah, that makes sense.

5 DR. NETON: There may be some low dose

6 situations, but like I say, almost by definition

7 if we feel that it's a low dose scenario, we

8 should be able to demonstrate that the

9 compensation probability is fairly low.

10 DR. ZIEMER: Okay, then we go to section

11 82.13, Sources of information for dose

12 reconstructions.

13 (No response)

14 DR. ZIEMER: 82.14, Types of information to

15 be used in dose reconstructions.

16 (No response)

17 DR. ZIEMER: 82.15, Completeness and

18 adequacy of individual monitoring data. 

19 (No responses)

20 DR. ZIEMER: I suspect many of the questions

21 have already been answered that pertain to some

22 of these sections.

23 82.16, how will NIOSH -- oh, question. Jim,

24 please.

25 DR. MELIUS: I'm a bit slow, I'm back to
262 

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1 82.14.

2 DR. ZIEMER: Am I moving too fast for you

3 here?

4 DR. MELIUS: Well, it's just when there's

5 sort of what appears or attempts to be an

6 exhaustive list, it's hard to figure out what's

7 not there. And maybe this is a question of how

8 you interpret some of this, but yeah, like under

9 (g), information regarding exposure, so on, is

10 there a place there where you talk about getting

11 information from co-workers? And 13, did I --

12 DR. DeHART: 82.13 takes care of that.

13 MR. KATZ: That’s actually –

14 UNIDENTIFIED: 82.13?

15 MR. KATZ: Yes.

16 UNIDENTIFIED: The previous section.

17 DR. MELIUS: Okay. Okay, okay.

18 DR. ZIEMER: Okay? Then back to 82.15, How

19 will NIOSH evaluate completeness and adequacy of

20 individual monitoring data?

21 (No response)

22 DR. ZIEMER: 82.16. Wait, 15, Henry?

23 DR. ANDERSON: Well, I'm going back to the

24 dose reconstruction. I was looking for the

25 medical --
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1 DR. ZIEMER: What section are you at?

2 DR. ANDERSON: Under 82.14, is --

3 DR. ZIEMER: Fourteen, okay.

4 DR. ANDERSON: Is the X-ray machine from the

5 surveillance program somewhere there? I'm just

6 quickly looking.

7 MR. KATZ: Yes, it's in there.

8 DR. ANDERSON: Okay.

9 UNIDENTIFIED: That's (f)(1).

10 DR. ZIEMER: Third column.

11 DR. ANDERSON: Ah, okay. I see, okay. I

12 took that to be measurements that may have been

13 made in the facility, not in the medical --

14 there's medical screening, I see. Thank you.

15 DR. ZIEMER: Yeah, we got it. Thank you.

16 Let's see here, we're back to -- I think we

17 did 15. Sixteen, 82.16, okay.

18 (No response)

19 DR. ZIEMER: Seventeen, 82.17. Co-worker

20 data shows up here, too, as well.

21 (No response)

22 DR. ZIEMER: 82.18, on calculation of

23 internal dose to the primary cancer site.

24 (No response)

25 DR. ZIEMER: 82.19?
264 

NANCY LEE & ASSOCIATES

1 (No response)

2 DR. ZIEMER: Okay, Subpart D, Reporting and

3 Review of the Dose Reconstruction Results; 82.25,

4 When will NIOSH report dose reconstruction

5 results and to whom?

6 (No response)

7 DR. ZIEMER: 82.26, How will NIOSH report

8 dose reconstruction results? 

9 (No response)

10 DR. ZIEMER: No questions, okay.

11 82.27, How can claimants obtain reviews of

12 their dose reconstruction results? No questions?

13 (No response)

14 DR. ZIEMER: 82.28, Who can review NIOSH

15 dose reconstruction files on individual

16 claimants?

17 I have one question. I don't know that this

18 would be something that would be in the rule, but

19 is there a plan to provide summary information

20 that's not identified by persons, but the

21 particular claims and or groups of claims,

22 numbers that have been processed and the

23 decisions and so on, or how will that sort of the

24 summary information be made available?

25 MR. ELLIOTT: Yes, we intend to provide
265 

NANCY LEE & ASSOCIATES

1 summary information, and I'll speak about it in

2 two ways. 

3 One, statistics like I showed you this

4 morning on number of claims received, where

5 they're at in the process, dose reconstructions

6 completed, DOL will maintain statistics on award

7 versus non-award.

8 Secondly, we talked about technical basis

9 documents that support the implementation

10 guidelines, and summary information from learned

11 experience in dose reconstruction will be

12 incorporated into those and available to the

13 public.

14 DR. DeHART: Just to follow one, I would

15 think that the medical literature that could be

16 generated from these studies are critically

17 important, because the assumption is going to be

18 made by some that what you are doing is

19 identifying causation, and that is not

20 necessarily the case. And there needs to be a

21 separation in that through the medical

22 literature, through publication.

23 DR. ANDERSON: Yeah, I would -- I think the

24 last sentence there under (b) of researchers will

25 not receive names of claimants is a pretty
266 

NANCY LEE & ASSOCIATES

1 categorical statement, and it would seem to me

2 you may want to put in without the individual's

3 permission. Because in reality, this is saying

4 if the workers would like to participate in a --

5 or their families, in a research study that would

6 help elucidate the health impacts, and you want

7 to combine this dose reconstruction with a

8 previously-identified cohort, there'll be no

9 linkage.

10 And I think if there's benefit accrues to

11 the individual to at least be offered -- we've

12 received a request, would you be willing to have

13 your whoever it is provided to them, at least

14 give the opportunity of the individual to

15 decline, rather than decline up front in the

16 statute on their behalf, basically saying that

17 these results won't be available linked, so

18 there'd be no way to do a mortality study linking

19 it to specific individuals without their work

20 history.

21 MR. ELLIOTT: There's two points to be made

22 in your comment here. 

23 One is that -- generally a response here is

24 that the Privacy Act controls how we disseminate

25 information that has personal identifiers on it.
267 

NANCY LEE & ASSOCIATES

1 This item (b) here that you're speaking from

2 allows researchers who come forward with

3 Institutional Review Board-approved protocol to

4 gain -- that is supported by a NIOSH funding

5 source, either through a grant or a contractual

6 mechanism -- identifiable data through our

7 records, systems of records held under the

8 Privacy Act. So all of the case file information

9 that is incorporated into our systems of records

10 can be released to a researcher with an approved,

11 IRB-approved protocol, okay.

12 If there are researchers out there who have

13 an interest to utilize this information but do

14 not have a NIOSH funding mechanism that brings

15 them into our routine use authority under our

16 Privacy Act system of records, then they would

17 have to approach us for a de-identified data set.

18 DR. ANDERSON: See, I -- the way I read it,

19 it says researchers will have limited access,

20 which says not everything, and that's subject to

21 provisions, I agree. But that last sentence

22 basically, to me, defines that limited access

23 means you will not get, and it says researchers,

24 whether they're part of the Privacy Act or not,

25 will not receive names or claimants or covered
268 

NANCY LEE & ASSOCIATES

1 employees.

2 MR. ELLIOTT: This needs to be written

3 better for clarification, because researchers

4 inside NIOSH and researchers supported through

5 NIOSH grants program who have an approved

6 protocol would be eligible to receive

7 identifiable information.

8 DR. ANDERSON: Right.

9 MR. ELLIOTT: Researchers who are not within

10 that realm would have to request information, but

11 they would be getting a de-identified data set.

12 DR. ANDERSON: Right, I'm just saying that

13 the way I read it here. I would interpret this

14 to say --

15 MR. ELLIOTT: I can see that.

16 DR. ANDERSON: -- since you say it's limited

17 up front, it's limited in that in no case, IRB or

18 not, you won't get it. So I would suggest you

19 might want to reword that, or you'll eliminate

20 all that research.

21 MR. KATZ: Yeah, just to clarify intent

22 here, that's helpful. And this provision is here

23 because the Act itself required that we make some

24 provision to provide general information from

25 these to researchers and the public who wouldn't
269 

NANCY LEE & ASSOCIATES

1 come under our umbrella of the Privacy Act.

2 DR. ANDERSON: Then I think you need to say,

3 for those who do not have an IRB approval. I

4 mean, researchers versus the public.

5 DR. ZIEMER: Well, clearly it needs to be

6 clarified.

7 DR. ANDERSON: Yeah.

8 MS. KELLEY: Larry, there is an exception to

9 the Privacy Act or an exemption. An person, an

10 individual can waive their right to privacy for

11 certain conditions. I don't know that that would

12 be something that would be normally done for a

13 large study, but an individual can waive. So if

14 they wanted to make their situation public, I

15 suppose they could.

16 DR. ZIEMER: Well, I think Henry's point is

17 this would seem to preclude even that, the way

18 it's written.

19 DR. ANDERSON: Yeah.

20 DR. ZIEMER: Right.

21 MR. ELLIOTT: That's true, Alice, but I want

22 to make sure everybody understands. We are not

23 seeking from claimants, from the Energy employee

24 or their survivor who's filing a claim, a release

25 of such sort. We're not making that a matter of
270 

NANCY LEE & ASSOCIATES

1 practice or policy.

2 DR. ZIEMER: Okay. Then it appears that we

3 have completed the sort of overview review of the

4 document. 

5 I am going to propose that we have a working

6 group that could prepare some preliminary

7 statements for us, even this evening, statements

8 that could be presented publicly tomorrow so that

9 we don't get into the kind of bind we had before

10 in having to do a document sort of off-line and

11 by e-mail and so on. 

12 And so I would like to seek volunteers again

13 who -- and it could be a few or all, but if I had

14 three or four folks who believe they have enough

15 energy this evening to make an early stab at some

16 wording, at least in answering the three

17 questions. And we can certainly add a couple of

18 other things, such as the point that Henry just

19 made on that clarification. I think, Jim, you

20 had another point earlier that I don't recall

21 what it is, but a couple of those comments would

22 be appropriate to add as sort of general

23 comments. And then try to address the three

24 questions. 

25 So are there those who are just anxious to
271 

NANCY LEE & ASSOCIATES

1 draft this? I know everyone's avoiding making

2 eye contact.

3 DR. DeHART: Some of us would like to get

4 home in the evening tomorrow, since it is

5 February the 14th.

6 DR. ZIEMER: Yeah, there –

7 DR. DeHART: It's already costing me.

8 DR. ZIEMER: Right. Make good eye contact

9 and we'll help you out. 

10 Larry has a suggestion here.

11 MR. ELLIOTT: We are ahead of our agenda, to

12 a certain extent. I suggest to you that you

13 might be able to do this tomorrow morning. If

14 individually you --

15 DR. ZIEMER: If everyone's too tired.

16 MR. ELLIOTT: Yeah, if individually somebody

17 wanted to work on their comments and bring them

18 forward in the morning, we could work together on

19 them tomorrow morning.

20 DR. ZIEMER: Let me ask the group, because

21 this has been a long day. I don't want to overdo

22 it, but if you'd rather give some thought and

23 maybe jot down, rough out some ideas tonight, and

24 then we'll get them on the table tomorrow and

25 have a chance to work through them, I think we
272 

NANCY LEE & ASSOCIATES

1 would have, time-wise have the opportunity

2 because we are a bit ahead of schedule.

3 UNIDENTIFIED: (Inaudible)

4 DR. ZIEMER: I’m sorry?

5 UNIDENTIFIED: That’s an off-the-record

6 comment.

7 DR. ZIEMER: Jim.

8 DR. MELIUS: Yeah, I would agree that doing

9 it tomorrow morning, I think, would make more

10 sense. I think if we got some general discussion

11 going about the sort of generalities, then I

12 think it's a lot easier to come to agreement on

13 specific statements at that point.

14 But I guess it would be helpful if we

15 clarify the schedule issue, though, before we

16 adjourn, because there's issues related to public

17 comment and so forth. Are we planning on meeting

18 for the whole day tomorrow, or is there --

19 DR. ZIEMER: Our main job tomorrow is to

20 develop these comments. And to the -- and

21 basically we are already at least an hour ahead

22 of schedule because we just completed doing what

23 we had scheduled for the 9:15 hour tomorrow, and

24 we have basically blocked off also two additional

25 hours in the afternoon. So there's -- really the
273 

NANCY LEE & ASSOCIATES

1 bulk of the time tomorrow was set down for this

2 very task, so we certainly can pick it up first

3 thing in the morning and get it underway.

4 DR. MELIUS: I would just add that maybe we

5 want to move up the public comment period if we

6 think we might finish earlier, do that around

7 lunchtime, either before or after lunch.

8 DR. ZIEMER: Yes. Although in fairness,

9 since the agenda was publicly promulgated and

10 some of the public may have scheduled themselves

11 to be here at that time, we would still need to

12 allow a public comment period at that point. But

13 we can certainly entertain public comments

14 earlier as well, sure. 

15 Henry.

16 DR. ANDERSON: Just as we talk about

17 drafting here, I'm just wondering do we want to

18 have a brief discussion now, or do we want to

19 recommend in this rule, as we did in the previous

20 one, a role for the Board? I notice in the

21 preamble again it talks about the role of the

22 Advisory Board in reviewing --

23 DR. ZIEMER: Right. We actually sort of

24 referred to that earlier, and then the idea that

25 we would probably do something similar in
274 

NANCY LEE & ASSOCIATES

1 codifying --

2 DR. ANDERSON: I think it's a good idea.

3 DR. ZIEMER: -- codifying the Board's role

4 there. 

5 Larry.

6 MR. ELLIOTT: Along that line, I would call

7 your attention to the agenda item tomorrow

8 morning, 10:30 to 11:30, to discuss the Board

9 work schedule. 

10 We need to make a decision tomorrow about

11 our tentative meeting date of March 25th and

12 26th, and what we would have as an agenda if we

13 want to go ahead and hold that meeting that date.

14 If not, then what would look like the next best

15 available date for us to meet. I'm not sure that

16 we can guarantee that we're going to have the

17 Special Exposure Cohort guide, petitioning

18 guidelines available by March, so we need to talk

19 in terms about that.

20 DR. ZIEMER: Okay. So that's an issue.

21 Again, you can cogitate on that this evening and

22 be ready to discuss that also in the morning.

23 DR. MELIUS: Be up all night.

24 DR. ZIEMER: Yes. Any other -- is that

25 agreeable? Any other comments?
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1 (No response)

2 DR. ZIEMER: Do I take it, then, that by

3 consent that you're prepared to work on your own

4 this evening to the extent you're able, and come

5 prepared to work through this tomorrow morning?

6 And if we can finish earlier in the day that will

7 be fine, and those that need to leave will be

8 able to do so.

9 Everybody's making eye contact. I take that

10 as a definite plus, okay. Yes, let's do that.

11 That sounds great, okay. If that's agreeable,

12 and it appears to be, then we'll be in recess

13 until tomorrow morning. Thank you very much.

14 (Whereupon, the meeting was

15 adjourned at 4:50 p.m.)

16 - - -

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277 

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

270 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 6

th day of

March, 2002.

__________________________

_

KIM S. NEWSOM, CCR-CVR

CCR No. B-1642

[SEAL]