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1 Presidential Advisory Committee

Department of Health and Human Services

Centers for Disease Control and Prevention (CDC)

 National Institute for Occupational Safety and Health 

 (NIOSH)

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, 525 New Jersey 

Avenue, N.W., Washington, D.C., on May 2 and 3, 

2002. 

NANCY LEE & ASSOCIATES 

Certified Verbatim Reporters 

P.O. Box 451196 

Atlanta, Georgia 31145-9196 

 (404) 315-8305 
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2 C O N T E N T S

 Vol. I 

Registration and Welcome 

Dr. Paul Ziemer, Chair 

Mr. Larry Elliott, Executive Secretary. . . . . . . . .8 

Welcome and Opening Remarks 

Dr. Kathleen Rest, NIOSH . . . . . . . . . . . . . . .11 

Review and Approval of Draft Minutes 

Dr. Paul Ziemer, Chair. . . . . . . . . . . . . . . . 18 

Program Status Report 

Mr. Larry Elliott, Executive Secretary . . . . . . . .36 

Changes to Probability of Causation Rule 

(42 CFR Part 82) 

Mr. Ted Katz, NIOSH . . . . . . . . . . . . . . . . . 70 

NCI-IREP 

Dr. Charles Land, NCI . . . . . . . . . . . . . . . . 82 

NIOSH-IREP in use by DOL 

Dr. Mary Schubauer-Berigan, NIOSH . . . . . . . . . .115 

Mr. Russ Henshaw, NIOSH . . . . . . . . . . . . . . .176 

Topics for Future Discussion 

Dr. Paul Ziemer, Chair . . . . . . . . . . . . . . . 193 

Public Comment . . . . . . . . . . . . . . . . . . . 207 

Discussion of Changes in the Rule . . . . . . . . . .216 

Adjourn . . . . . . . . . . . . . . . . . . . . . . .223 
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C O N T E N T S

 Vol. II 

Registration and Welcome 

Dr. Paul Ziemer, Chair 

Mr. Larry Elliott, Executive Secretary . . . . . . . 227 

Administrative Housekeeping 

Ms. Cori Homer, NIOSH . . . . . . . . . . . . . . . .227 

Discussion of Rules. . . . . . . . . . . . . . . . . 237 

Legislative History 

Dr. David Michaels, George Washington University. . .268 

Public Comment Period . . . . . . . . . . . . . . . .327 

Adjourn . . . . . . . . . . . . . . . . . . . . . . .344 
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P A R T I C I P A N T S 4

 

CHAIR

ZIEMER, Paul L., Ph.D. 

Professor Emeritus 

School of Health Sciences 

Purdue University 

Lafayette, Indiana 

EXECUTIVE SECRETARY

ELLIOTT, Larry J.

Director, Office of Compensation Analysis and Support 

National Institute for Occupational Safety and Health 

Centers for Disease Control and Prevention

Cincinnati, Ohio 

 

 

MEMBERSHIP

ANDERSON, Henry A., M.D. 

Chief Medical Officer 

Occupational and Environmental Health 

Wisconsin Division of Public Health 

Madison, Wisconsin 

ANDRADE, Antonio, Ph.D. 

Group Leader 

Radiation Protection Services Group 

Los Alamos National Laboratory 

Los Alamos, New Mexico 

 

DeHART, Roy Lynch, M.D., M.P.H. 

Director 

The Vanderbilt Center for Occupational and Environmental 

Medicine 

Professor of Medicine 

Nashville, Tennessee 

ESPINOSA, Richard Lee 

Sheet Metal Workers Union Local #49 

Johnson Controls 

Los Alamos National Laboratory 

Espanola, New Mexico 

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

Occupational Health Nurse Specialist 

Oak Ridge Associated Universities 
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Oak Ridge, Tennessee 5

Occupational Health 

GRIFFON, Mark A. 

President 

Creative Pollution Solutions, Inc. 

Salem, New Hampshire 

MELIUS, James Malcom, M.D., Ph.D. 

Director 

New York State Laborers' Health and Safety Trust Fund 

Albany, New York 

MUNN, Wanda I. 

Senior Nuclear Engineer (Retired) 

Richland, Washington 

PRESLEY, Robert W. 

Special Projects Engineer 

BWXT Y12 National Security Complex 

Clinton, Tennessee 

ROESSLER, Genevieve S., Ph.D. 

Professor Emeritus 

University of Florida 

Elysian, Minnesota 
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INVITED SPEAKERS

Dr. Kathleen Rest, NIOSH 

Mr. Ted Katz, NIOSH 

Dr. Charles Land, NCI 

Dr. Mary Schubauer-Berigan, NIOSH 

Mr. Russ Henshaw, NIOSH 

Ms. Cori Homer, NIOSH 

Dr. David Michaels, George Washington University
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STAFF/VENDORS

CORI HOMER, Committee Management Specialist, NIOSH 

MARIE MURRAY, Writer/Editor 

STEVEN RAY GREEN, Certified Court Reporter 

AUDIENCE PARTICIPANTS

Neil Barss 

William Beckner 

Jim Blankenship 

Fred Blosser 

Jeff Eagan 

Don Elisburg 

Joe Fitzgerald 

Tracey Gilbertson 

Alice Kelley 

Jeff Klemm

Jeffrey Kotsch

Tim McAdams

Martin Mathamel

Richard Miller

Frank Morales

Jim Neton

Louise Presley 

Jerome Puskin 

Randy Rabinowitz 

Mark Reinhalter 

Genevieve Roessler 

Malia Rulon 

Michael Schaeffer 

Mary Schubauer-Berigan

Josh Silverman

Robert Tabor 

Liz Titus

Nancy Zuchernol
 The following transcript contains quoted material. 

Such material is reproduced as read or spoken. 

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 TRANSCRIPT LEGEND 8

 In the following transcript a dash (--) indicates an 

unintentional or purposeful interruption of a sentence. 

An ellipsis (. . .) indicates halting speech or an 

unfinished sentence in dialogue or omission(s) of word(s) 

when reading written material. 

 In the following transcript (sic) denotes an 

incorrect usage or pronunciation of a word which is 

transcribed in its original form as reported. 

 In the following transcript (phonetically) indicates 

a phonetic spelling of the word if no confirmation of the 

correct spelling is available. 

 In the following transcript "uh-huh" represents an 

affirmative response, and "uh-uh" represents a negative 

response. 
 (8:15 a.m.) 

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 P R O C E E D I N G S 9

 DR. ZIEMER: Good morning, everyone. I'd 

like to call to order the third or fourth, depending 

whether you count the teleconference. I guess it's 

the fourth official meeting of the Advisory Board on 

Radiation and Worker Health. 

 We're pleased at this meeting to welcome one 

new member to the Advisory Board. That new member 

is Mark Griffon. Mark, you can raise your hand over 

here. I'm sure most or all of the Board members 

have met Mark, but just let me take a moment and 

indicate a little bit about Mark's background. 

 Mark has served as president of Creative 

Pollution Solutions in New Hampshire since 1992 and 

in that capacity he performs consulting services in 

the radiation and hazardous waste field. He also 

presently serves as program director for the 

Department of Energy's medical surveillance research 

program for the gaseous diffusion plant exposure 

assessment, and he also is a member of the advisory 

board of the U.S. Transuranium and Uranium 

Registries. Mark did his undergraduate work at 

Rensselaer Poly Tech and his graduate work, 

including an M.S. and Ph.D. from the University at 

Massachusetts at Lowell. And Mark, we welcome you 

to the committee, look forward to your 
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 10 participation. 

 MR. GRIFFON: Just one correction there -- I 

don't have the Ph.D. yet. 

 DR. ZIEMER: Well, that's interesting, 

because President Bush thinks you do. 

 (LAUGHTER) 

 DR. ZIEMER: We'd better keep that secret. 

No, actually what I just read is from the White 

House news page, so -- well, even worse than that, 

they had my name spelled wrong, so... 

 Okay, in any event, we still welcome you, 

Mark, in spite of your lack of that degree. 

 I'd like to remind everyone here, including 

the Board members and all visitors, to please 

register your attendance with us today. There's a 

registration or sign-in book on the table, so please 

take care of that if you have not already. 

 Those of the general public who wish to make 

comments during the public comment period, there is 

a sign-up page in one of the other books there at 

the table and we ask you to sign up, simply so we 

can assess how many will be wanting to speak and the 

allotment of times. 

 We're pleased to have with us this morning 

Dr. Kathleen Rest, who is the acting director of 

NIOSH -- Rust, I said Rest -- it is Rest; I get a 

little rust on my eyes here. Dr. Rest is acting 
1 director of NIOSH. We're pleased to have her with 

us this morning again. And Dr. Rest, if you would, 

please come and address the group and we'll give you 

the podium here for that purpose. Thank you. 

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 DR. REST: Thank you and good morning, 

everyone. I guess we have to speak up over the 

rain. Larry Elliott just looked up and said I hope 

this doesn't leak. 

 I'm happy to be here this morning and to 

welcome all of you again on behalf of NIOSH, the 

National Institute for Occupational Safety and 

Health, to this the fourth meeting of this Advisory 

Board on Radiation and Worker Health. And I'd like 

to start off first of all by thanking you for all of 

the efforts that you've made on behalf of NIOSH, HHS 

and this program. Really and truly, you've worked 

very hard over the past number of months to help us 

meet some of the new responsibilities and 

accomplishments that we had to achieve, and I truly 

appreciate the energy and the dedication that you 

brought to the task, so thank you very much for 

that. 

 Now I think that you all know that this 

program is really a very high-priority program both 

for NIOSH and for the Department of Health and Human 

Services. And we at NIOSH have been working really 

hard to be able to deliver on the many new 
responsibilities that we've been given under this 

program. 

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 Larry Elliott later on this morning is going 

to give you more of an up-date and status report and 

some of the details on our activities to date, but I 

just wanted to highlight a couple of significant 

milestones for you and we can turn it over and get 

on with the grist of the meeting. 

 I think that you all know that as of today 

the final rules on dose reconstruction and 

probability of causation have been published in the 

Federal Register, thanks in part to your own intense 

efforts to help us make this happen. A little 

history here is that we began drafting these rules 

last April, published both of them as -- well, one 

as a proposed rule and one as an interim final rule 

last October, and then obtained public comment, 

public input and Board input through February. And 

all of your efforts, as well as the efforts of the 

public and the public comments that we got, really 

helped us improve those rules and paved the way for 

their publication today. This publication now 

really makes it possible for claimants to have their 

cancer claims adjudicated by the Department of 

Labor, so beginning today, all cancer claims that 

are related to the non-Special Exposure Cohort 

claims will be able to be adjudicated by the 
Department of Labor using the new probability of 

causation rules with completed dose reconstructions 

under the dose reconstruction rule that has been 

finalized and put out there today. 

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 So we're very pleased that this is now 

behind us and that this helps move the whole program 

forward. And I think that finalizing -- developing 

and then finalizing these rules in the months that 

it took us to do it really I think is evidence of 

our strong commitment to the program. It seems like 

a very long time I guess for a rule to take a year 

from start to finish. But in truth, sometimes it's 

rather remarkable to have something published in 

that amount of time. So we did work as quickly and 

as hard as we could to get them out there. We thank 

you and we thank all of the members of the public 

that were able to provide the comments on this, and 

I'm pleased that they're there and that the program 

is now really able to be up and running in terms of 

the individual claims that will be submitted to the 

Department of Labor. 

 Now another important milestone that we 

really had hoped to be able to meet in time for your 

meeting here today relate to the procedures that the 

Department of Health and Human Services will use to 

consider petitions for additions to the Special 

Exposure Cohort, the SEC procedures. Unfortunately, 
1 you don't have them in front of you here today and 

we are also disappointed that they're not in front 

of you here today, and I want to make it I guess 

clear that we have worked as hard as we could to try 

to get them in front of you and they are now, I'm 

happy to say, in the final process of review. So I 

really expect that they will be published very soon 

for public comment and for Board review. 

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 We understand that these procedures are 

important. We understand their relationship to the 

overall program and we are as eager as all of you to 

get them out there, so I want you to know that we're 

fully committed to do our very best to turn them 

around now that we've gotten all of the comments -- 

the internal review comments back. We're ready to 

move as quickly as we can on that. 

 So in addition to the recommendations and 

the review that you will give those procedures when 

you see them, we also look forward to receiving your 

input and your advice on the NIOSH-IREP program that 

you're going to hear a little more about today. And 

of course on the implementation of the dose 

reconstructions that we do, I know you'll be 

actively involved in doing some quality control and 

reviewing how we're doing, once we've gotten quite a 

number of dose reconstructions under our belts. 

 So with that and in conclusion, I'd just 
like to thank you for all that you've done and 

assure the Board and assure all of our constituents 

about this -- our constituents in this program that 

NIOSH and the Department are really fully committed 

to see the implementation of this program proceed as 

quickly as possible, and to give you our very best 

efforts to make it run as smoothly and efficiently 

as possible. 

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 So with that, I'm happy to answer any 

questions or I will turn it over to Dr. Ziemer to 

continue with your agenda. 

 DR. ZIEMER: Thank you, Dr. Rest. I think 

it would be appropriate to allow a moment for 

questions. We obviously don't want to delve into 

the details of the final rule. I think we'll have 

an opportunity to do that later in the meeting. But 

are there some general questions that anyone has? 

Jim. 

 DR. MELIUS: Yeah, Kathy. You and I have 

talked about this before the meeting, but I am 

disturbed that the Special Exposure Cohort 

guidelines are taking so long to get out, and I 

understand it is a lot of work and there are just 

practical issues that way. But I think they are key 

to what -- for our committee to function; more 

importantly, for the recipients of the compensation 

under this program to have as one avenue for 
receiving compensation. And it makes it very 

difficult to put a whole -- understand the whole 

program and even to review parts of it without 

knowing how the whole program's going to put 

together. 

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 And I guess one other thing I'm sort of 

concerned about and I -- this is a question for you, 

is why -- since these are guidelines, these are not 

regulations, as I understand it, why the committee 

cannot be involved in reviewing those -- you know, 

why do we have to wait for all these other reviews 

to take place and then get presented -- those 

presented to the committee as something that's maybe 

not finalized, but certainly has gone through a lot 

of work and has gotten comments from other agencies 

internally, and then we're presented them after -- 

sort of after the fact, same time as the public, and 

then that it sort of seems to me delays the process 

even further. 

 And I think a better process would be to 

involve the committee in reviewing the concepts and 

reviewing the document ahead of time, since they are 

guidelines, not rules. 

 Regulations, we don't have the same 

restrictions on public, you know, input and access 

to those. So is there a reason for that? 

 DR. REST: I think that -- I mean you hit on 
it, in that they are procedures, and I think the 

issue is is that the Department that will be 

implementing the procedures wanted to make sure that 

they fully understand -- fully understood our 

thinking behind the proposed and draft procedures 

before putting them out for public comment and 

giving people an -- within, giving people an 

opportunity to take a look at them. I can tell you 

that -- you know, I fully agree with you. I 

couldn't agree more with the importance of getting 

these procedures out for public comment as quickly 

as possible, and I assure you that we will -- we are 

nearly there. We hope to have the public comment 

period quite long enough so that people will have an 

opportunity to really understand them. We're happy 

to do some briefings on them as soon as they get out 

there, and I think that where we are at the moment 

is weeks away from getting them in front of you and 

getting them in front of the public. So I do want 

to let you know that I fully appreciate what you're 

saying and I do understand the importance of it. I 

think we all do. And we will do our very best to 

get them to you as quickly as possible. 

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 DR. ZIEMER: Are there further questions or 

comments? Thank you very much. I guess this 

constitutes our "Rest" break and we'll continue with 

the meeting. 
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 DR. REST: 18 Okay. 

 DR. ZIEMER: We have as an item of business 

the review and approval of draft minutes. There are 

three such sets of draft minutes from the two 

meetings that were held here, plus the 

teleconference meeting. And before we actually take 

action on those, I'd like to make a few remarks 

about what it is we're going to do in approving the 

minutes. And I do this recognizing that perhaps 

some of you did not see the minutes till you arrived 

here last evening and got your big books, although 

-- and the minutes I think are also on the web site, 

are they not? Right. 

 In any event, you have -- you have before 

you this morning -- we're all a little curious as to 

why we all got copies of Roberts' Rules, wondering 

if now that Mr. Griffon's on the committee we have 

to rein things in or whether we were so wild before 

that somebody's hinting something. But I don't 

think that's the case. I think there was a closeout 

sale from -- NIOSH, I guess we thank you for this. 

Yes, thank you -- always nice to have another book. 

 But anyway, if you were to read in Roberts' Rules -

- and it's around 150-something -- about minutes, 

what you learn is that minutes, under Roberts' 

Rules, basically consist of an enumeration of the 

formal actions taken; that is, the motions, any 
amendments thereto, who made the motions and the 

voting; summary or listing of reports given, that 

sort of thing. 

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 On the other hand, what we have and what's 

required under the rules of advisory boards of our 

type, under the FACA rules, is more than just what 

Roberts' Rules call for. It calls for additional 

information about the discussions and that sort of 

thing. 

 Now we could spend literally hours, because 

some of these minutes are pretty extensive. We 

could spend hours going through these line by line 

or paragraph by paragraph, and it would take very 

long. But in order to efficiently handle the 

approval of the minutes, and these three sets of 

minutes, what I'm asking that you do is consider the 

following. You can ask yourself two questions. 

Number one, are the motions and the votes correctly 

accounted for and correctly stated and recorded? 

And secondly, are there any significant omissions or 

errors of fact or -- in places where your view was 

stated -- any significant distortions or incorrect 

statements of things you might have said? 

 If there are other kinds of corrections, 

such as wordsmithing, spelling, grammatical things, 

we simply ask that you enumerate those on your own 

and pass those on to Cori. We're not going to 
wordsmith the minutes here this morning. We're 

looking for substantive changes, additions or 

corrections in the actual actions of this Board, as 

well as substantive changes in items that were 

discussed. 

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 Now let me ask the Board -- this is what I'm 

suggesting. Let me ask if you believe that that's 

an appropriate way to proceed on the actions on the 

minutes. Are there any objections to proceeding in 

that manner? I see no objections so I'll take it 

that that's fully agreeable. 

 And incidentally, minutes can always be 

corrected later. If there's something you find 

later that shows up and you say, you know, we didn't 

correct that, we can always do that again later. 

 Well, with that in mind, let us turn to the 

first set of minutes. And for the members of the 

public who are here, I believe there are sets of 

those minutes on the table in the rear corner, so if 

you want copies of those, they are available. I 

should tell you that in addition to the individual 

who originally prepared these minutes, the staff has 

reviewed them extensively. Your Chairman has spent 

a number of hours reviewing these, both for 

grammatical as well as technical content, and we 

have had a lot of changes already made. 

 The first set of minutes, which includes 
both an executive summary and full description of 

our deliberations at our first meeting -- and 

there's some 36 pages in the body of those minutes, 

plus the pages of the executive summary -- I'd like 

to ask if there are any corrections or additions to 

those minutes, keeping within the guidelines that we 

just discussed. 

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 Yes, Dr. Anderson? 

 DR. ANDERSON: I don't have any additions. 

I just wanted to get a clarification. Is there a 

transcript -- 

 DR. ZIEMER: Yes -- 

 DR. ANDERSON: -- a written -- is there a 

written transcript or is it just a recorded 

transcript? 

 DR. ZIEMER: No, there is also a transcript, 

which is pretty much verbatim of everything -- or 

most everything that was said. And let me ask, is 

that transcript also on the web site or -- it is on 

the web site, so a lot of pages there. 

 DR. ANDERSON: Yeah, because that pretty 

much captures -- so between the minutes and that, I 

think we're -- we're well-covered. 

 DR. ZIEMER: Thank you. 

 DR. ANDERSON: So I'd move we accept. 

 DR. ZIEMER: Okay, there's a motion to 

accept those minutes. Let me ask for a second, then 
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 22 we'll -- 

 DR. ANDRADE: Before you go forward, I would 

just like to note that I think this rises to the 

level above grammatical error, but on the first set 

of minutes -- not the executive summary -- in the 

list of attendants, yours truly was left off, and I 

know that I was here at least in body. 

 DR. ZIEMER: I think that rises above the 

grammatical error. Thank you for that. Please 

check your attendance list, make sure you're 

included. 

 With that understanding, a motion to 

approve, with the addition of -- was there a second 

to that? 

 DR. DEHART: I'll second. 

 DR. ZIEMER: Well, let me ask now for 

corrections or additions or -- Wanda? 

 MS. MUNN: I know it's better for me not to 

have a microphone sometimes, but... On page five of 

the February 5th minutes -- 

 DR. ZIEMER: We're only doing the first set 

of minutes. Is that February 5th? 

 MS. MUNN: Oh, we're only doing the first -- 

 DR. ZIEMER: We're on the January minutes 

right now. 

 MS. MUNN: We're on the January minutes. 

 DR. ZIEMER: Yes, so hold that thought. 
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 MS. MUNN: 23 All right, fine. 

 DR. ZIEMER: Any other items on the January 

minutes? Okay, I'll just call for a formal vote on 

approving. All in favor of approving the minutes 

with the addition of Tony Andrade's name, say aye. 

 (Affirmative responses) 

 DR. ZIEMER: Any opposed, then say no. 

(No negative responses) 

 DR. ZIEMER: The minutes are approved. Now 

we'll look at the February 5th minutes and that's 

the conference call meeting. Are there -- I'll 

simply call for corrections or additions to the 

minutes at this point. Now, Wanda, page five you 

say? 

 MS. MUNN: Yes. No, that's fine, go ahead. 

 DR. ZIEMER: You're okay, did you say? 

 MS. MUNN: Yeah, I'm okay. I was confusing 

one meeting with another. 

 DR. ZIEMER: Okay. We're on the February 

5th minutes. Any additions or corrections? Hearing 

none, I'm simply going to call for an action. All 

in favor of approval of the minutes, say aye. 

 (Affirmative responses) 

 DR. ZIEMER: Any opposed, say no. 

(No negative responses) 

 DR. ZIEMER: Those minutes are approved. 

Let's now go to the minutes of the third meeting 
24 held February 13th and 14th. Are there corrections 

or additions to the minutes? 

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 (No response) 

 DR. ZIEMER: Any of the Board members wish 

to have a little more time? I'll just pause, I see 

you leafing through looking for markup. 

 MS. MUNN: Yes, I would really appreciate 

having an opportunity to actually go through these. 

 I did not get them until last night and, mea culpa, 

I did not -- I was not aware that they were on the 

web site. I would have looked at them earlier. 

 DR. ZIEMER: I think we have time. Let me 

just -- I won't declare a recess, but let's take -- 

allow about ten minutes or so. Is that -- 

 MS. MUNN: I'd very much appreciate that. 

 DR. ZIEMER: We'll just pause and allow 

about that much time, and others who -- in the 

general public who may have just gotten an 

opportunity to look at those may wish to have a 

chance to peruse them in any event, so we'll just 

pause in our proceedings here for the time being. 

You can take a break if you wish, but if you haven't 

had a chance to go through these, just take the 

opportunity and -- including the ones you just 

approved. If you need to back up, that's fine, 

we'll do that. 

 (Whereupon, the meeting was suspended 
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 25 briefly to review the minutes.) 

 DR. ZIEMER: It appears that folks are done 

with reviewing the minutes since there are a number 

of sidebar conversations, so let's go back. Dr. 

Anderson? Thank you. 

 DR. ANDERSON: As one who typically just 

reads the minutes from a lot of meetings, I would 

like to see on all of the minutes, right up at the 

first statement there where it talks about convene 

the meeting, February 13 and 14, Washington Court 

Hotel -- I'd like somewhere in the minutes, and 

probably that's a good place, to say something like 

a court reporter transcribed the deliberations of 

the Board and the complete transcription is 

available for public review and on the web page or 

something like that, just so that, in a concise 

place like this, it is somewhat unusual to have a 

court reporting of -- verbatim of the whole meeting 

for a FACA committee. I think it's important for 

people to know that if you read the minutes and you 

say gee, I wonder what they were talking about, here 

it says where you can find it as well. 

 DR. ZIEMER: Your comments pertain to 

changing these minutes as well, or just the future 

minutes? 

 DR. ANDERSON: Yes, I would -- it could 

either be in the future, but I would think all of 
the minutes, just to make a statement that it was 

reported. That way -- you know, it's part of the 

minutes that it was done. 

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 DR. ZIEMER: That's a reasonable -- 

 DR. ANDERSON: Yeah. 

 DR. ZIEMER: -- suggestion. Any objections 

to that? 

 (No response) 

 DR. ZIEMER: We'll take it by consent that 

future minutes should contain that. We can 

certainly add it -- there may be some other things 

on these that need some additional changes. 

 Okay, let me -- although we've officially 

approved the first and second meetings, let me ask, 

are there any other items on the first meeting? I 

have one. This does not include some additional 

dangling participles which I have now identified and 

I will pass along on the side, but one which is a 

technical matter occurs on page 24 -- I just doublechecked this with Jim Neton -- and it talks about 

ICRP-60 rating factors, when in fact it should be 

talking about ICRP-60 weighting factors, so the word 

-- the last paragraph on page 24 should refer to the 

ICRP-60 weighting factors. We had in fact caught 

that earlier, but it somehow didn't get changed in 

the final version. It should be weighting factors. 

 Gen Roessler? 
 DR. ROESSLER: 2 In the minutes of the first 

meeting on January 22nd -- I think I have the day 

right -- on page 14 is a comment I brought up and I 

just want to clarify a word there. Maybe if I went 

on the web site and found out my exact wording it 

would be clarified, but -- are you on page 14? -- it 

says discussion included, the third item is 

(Reading) Congress picked the 99 percent confidence 

level, but the claims of individuals with a cancer 

with little literature on it will be jeopardized -- 

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 And so on and so forth. I remember all the 

rest of that, but I don't think the word jeopardized 

is right. I think it's just the opposite. I think 

in the case where there's a large range of 

uncertainty, certainly jeopardized is the opposite 

of what -- am I right on that, Jim? 

 UNIDENTIFIED: That's correct. 

 DR. ROESSLER: So maybe a word -- we need to 

look at that word jeopardized. This goes down in 

the record. It is one of the main comments I had at 

that meeting and I'd like to make sure that that's 

corrected. 

 MS. MURRAY: Could you suggest a substitute, 

Dr. Roessler? Supported or aided? 

 DR. ROESSLER: Well -- what was the next 

one? 

 MS. MURRAY: Aided? 
 DR. ROESSLER: That would be putting it 

mildly, but it would be better than jeopardized. 

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 DR. ANDRADE: Gen, can I suggest the word 

enhanced? 

 DR. ROESSLER: I like that, Tony, yes. 

 DR. ZIEMER: Any objection to changing the 

minutes then to read enhanced, which is technically 

what the concept is, just the opposite of what's 

here? So thank you. 

 Are there any others? We're still on the 

first meeting minutes. 

 MS. MUNN: I have a question. 

 DR. ZIEMER: You have a question? Thank 

you. 

 MS. MUNN: On page 3/5 up front, third 

paragraph, (Reading) Acute exposure was defined by 

the National Academy of Sciences as of hours of 

exposure. 

 I looked at that and thought we have a 

missing word somewhere. 

 DR. ZIEMER: It's the word of, there's an 

extra of, I think, it's -- As I recall, they were 

defining it as acute if it occurred over a period of 

hours, so it would be as -- 

 MS. MUNN: I thought perhaps the number of 

hours. 

 DR. ZIEMER: -- as hours -- not necessarily 
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 29 number. 

 MS. MUNN: No. 

 DR. ZIEMER: I think -- 

 UNIDENTIFIED: Duration. 

 DR. ZIEMER: -- duration. 

 MS. MURRAY: A few -- a few -- chronic dose 

thereafter is defined as more than a few hours, so 

acute would be a few hours? 

 MS. MUNN: Acute hours (sic) is defined as 

two or more? What? 

 MS. MURRAY: I don't know. 

 DR. ZIEMER: I believe it was a little 

fuzzier than a number like two -- a few might -- 

would a few be agreeable? It's -- here again, it's 

the concept. A few hours of exposure is what it 

would read now. Is that okay? 

 UNIDENTIFIED: (Inaudible) less than a few 

hours? 

 DR. ZIEMER: A few hours of exposure or 

less? A few hours or less of exposure. 

 UNIDENTIFIED: Okay. 

 DR. ZIEMER: Now again, we're not trying to 

refine this to get at exact definitions, but we are 

trying to clarify what the concept was there, 

technically speaking. Thank you for that. 

 Now, any other significant changes to those 

minutes? 
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 DR. ZIEMER: Now although we approved them, 

we had pointed out that under Roberts' Rules

certainly you can always go back. I'm not going to 

go through the formal process of asking that there 

be a motion to recall and all that. Let me simply 

ask now that we reaffirm our approval with these 

additional changes. 

 Are there any objections to approving with 

these additional changes? 

 (No response) 

 DR. ZIEMER: If not, I'll then call for 

simply a vote. All who favor approval of these 

minutes with these additional changes, say aye. 

 (Affirmative responses) 

 DR. ZIEMER: Are there any opposed? Say no. 

(No negative responses) 

 DR. ZIEMER: Now they are reapproved. The 

new, improved version of the minutes. 

 Now, on the second set of minutes are there 

any additional things that got overlooked in our 

previous action? That's the teleconference minutes. 

 (No response) 

 DR. ZIEMER: No? We'll move on to the third 

set of minutes, which we haven't acted on at all 

yet. Are there corrections, additions or other 

changes for the third set of minutes? February -- 
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 DR. MELIUS: I'm not sure -- 

 DR. ZIEMER: Jim. 

 DR. MELIUS: -- we want to make this change, 

but it's a -- you go to page 18, beginning of -- 

February 14th where there's a discussion of topics 

suggested for the next meeting. I believe the 

discussion was obviously more extensive than is 

captured in these minutes. I think that's 

appropriate. I don't think the minutes should be 

detailed. But I do think that it would be helpful 

if there was a way of making sure that Larry or his 

staff captured these suggestions and they had come 

up -- the first meeting also at points we had talked 

about what topics should we discuss at future 

meetings. And I know when we then went to set up 

this meeting, and particularly when the special 

exposure guidelines got knocked off the agenda, then 

there was sort of a scramble, what should we do with 

this meeting, and I think it would be helpful if 

there was a -- someone kept a sort of a to-do list, 

you know, future meeting topics, information that 

needs to get to the committee and so forth, and that 

we have some way that we make sure we capture that. 

 Not necessarily in the minutes, though. If the 

only way to do it is going to be in the minutes, 

then I suggest that we make sure that the minutes do 
include that information, but I don't think that 

level of detail is necessary. You know, such as 

suggested speaker names and things like that. 

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 DR. ZIEMER: We'll take this simply as a 

comment to staff. You're not suggesting a change on 

these minutes at this point. 

 DR. MELIUS: No -- 

 DR. ZIEMER: Thank you. 

 DR. MELIUS: -- as long as Larry would think 

that we don't need to do it in the minutes to do 

that. I don't think we -- 

 DR. ZIEMER: Track those suggestions, right. 

 And Mark, did you have a comment? No. Other 

comments? Are you ready to take action on the third 

set of minutes then? 

 Okay, all who favor approval of the minutes 

of the February 13/14 minutes, please say aye. 

 (Affirmative responses) 

 DR. ZIEMER: Any opposed, say no. 

(No negative responses) 

 DR. ZIEMER: That motion carries. Thank 

you. Roy? 

 DR. DEHART: I would simply like to 

compliment the staff on the quality of the documents 

that we've just discussed. In reviewing them, as I 

had the opportunity to do last week, I found it not 

only brought the recall of what we were doing, it 
refreshed my memory on the science and it far 

exceeded my own notes, and I very much appreciate 

the opportunity to have these documents before me. 

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 DR. ZIEMER: So noted. Jim? 

 DR. MELIUS: One other procedural suggestion 

is I think it would be helpful if the staff could email us when things are posted on the web site. I 

thought we had talked about this before, but not all 

of us check it every day and some of us get caught 

up in the basketball scores and other things and 

never quite get around to looking at your web site 

daily, and it would be helpful if someone could -- 

whenever a new document goes up -- just send an email to the committee. 

 DR. ZIEMER: Duly noted. Comment from 

Larry? 

 MR. ELLIOTT: I do appreciate those 

suggestions and we will follow through with that. 

Our plan and intention has been to use e-mail to 

contact you as much and as frequently as possible. 

We did send the minutes out by e-mail. I regret 

that some of you evidently did not get the e-mail 

with the minutes. We need to check and make sure 

that we have your correct e-mail addresses and we 

will do so. But we did send out the minutes. All 

three sets of minutes went out by e-mail, and then 

they were also -- that e-mail also noted that they 
34 were posted on the web site, so I'm sorry that they 

didn't get to all of you. 

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 DR. ZIEMER: Thank you. Let's move on on 

our agenda. Next topic is program status report and 

Larry Elliott will present that. And there is a 

section in your Board booklet which is a copy of the 

power point materials. 

 MR. ELLIOTT: Well, good morning. I am 

pleased to be here with you at your fourth meeting. 

 And at your last meeting I introduced this 

presentation to you as a program status report and 

described the process steps in handling claims at 

NIOSH. Today I will provide you with an up-date of 

claims status at the Office of Compensation Analysis 

and Support in NIOSH and I'll give you some 

statistics on several of the more pertinent steps in 

the process. And during that I will also touch upon 

some of the things I think you're very concerned and 

interested in. 

 Again, the intent of this program report 

presentation is to provide you with a broader 

context of claims status at NIOSH so that you may 

determine when and how best to proceed with your 

responsibility to review completed dose 

reconstructions for scientific validity and quality. 

 As of last Friday, April 26th, it is our 

understanding that the Department of Labor has more 
than 15,000 non-Special Exposure Cohort cancerrelated claims for which they are verifying 

employment and medical diagnosis. In addition to 

that number, the Department of Labor has forwarded 

3,634 claims to NIOSH for dose reconstruction. 

While it's too early in the program to detect any 

trends in these numbers, as you can see, the receipt 

of claims at NIOSH has increased substantially each 

quarter. Keep in mind that we did not start 

receiving claims at NIOSH until October 11th, 2001. 

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 Claims are received in batches each week 

from the four district offices of the Department of 

Labor. And on Tuesday of each week we send out 

acknowledgement letters to each claimant to let them 

know that we have received their claim from the 

Department of Labor and we also tell them in that 

letter what the next steps will be for their claim, 

what steps their claim will go through, and how they 

may contact us to monitor progress. 

 You may note at this step that we lag behind 

the total number of claims we have in hand. We've 

sent out acknowledgement letters for 3,391. This 

lag represents a single week of claims receipt, and 

it's also the last step in the process where claims 

are handled as a batch. Now in your Board booklets 

we've provided you example copies of the 

acknowledgement letter and of the other letters that 
we use to communicate with claimants at various 

steps in the process. 

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 As we approach the Department of Energy with 

requests for information to support dose 

reconstruction -- I'm sorry, I hit the -- and I 

can't back up. 

 (Pause) 

 As we approach the Department of Energy with 

requests for information to support dose 

reconstruction, each claim is handled individually. 

 At this point the dose reconstruction portion of 

the case file is being developed for each individual 

claim. We evaluate the case file information for 

the cancer type, length of employment, the number of 

covered sites where the Energy employee worked and 

the number of different jobs that the Energy 

employee held. And if appropriate, we evaluate the 

NIOSH-held information for data pertinent to the 

claim. These evaluation steps enable us to focus 

our information needs based upon specific time 

periods and on location, where the employee might 

have worked, and to direct our requests to the 

Department of Energy -- the relevant sites for the 

Department of Energy. 

 You may note here that the number of claims 

achieving each succeeding step diminish as we 

proceed in the process. This is due to the time 
37 that's required to assemble, evaluate and review the 

information that's needed for dose reconstruction on 

an individual claim basis. Thus we have requested 

information from the Department of Energy sites for 

2,966 claims at this point. We anticipate when our 

dose reconstruction technical support contract is 

awarded next month that we will see more claims 

moving through the process at a much faster pace. 

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 We're working very closely with the 

Department of Energy and the designated points of 

contacts at the DOE sites for the information that 

we need to conduct these dose reconstructions, and 

we're exploring ways to expedite the fulfillment of 

our information requests. We're exploring how to 

build site-specific profiles with the Department of 

Energy. We're also examining ways to validate the 

information that's been provided, and to establish 

access to confidential information or National 

Security-held information. And we're also 

evaluating how we can best verify that no further 

information exists. 

 We're currently negotiating all of these 

points with the Department of Energy in the language 

for the memorandum of understanding between HHS and 

the Department of Energy. Within the last month, as 

you see, we've seen an improved response to our 

requests for information from most of the DOE sites, 
38 and I anticipate that we'll see improvement only get 

better as we proceed with a signed memorandum of 

understanding. 

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 Relative to a given claim, we evaluate the 

information provided by the Department of Energy for 

adequacy and completeness with regard to our 

specified information request. And we're evaluating 

here that not only the quantity but also the quality 

of information provided in the light of what we need 

to conduct the dose reconstruction for an individual 

claim. Where we feel that the information is 

incomplete or inadequate, we have approached DOE 

again for the necessary information, and thus to 

date we have reapproached DOE for additional 

information to support dose reconstructions on 51 

claims. 

 In some cases we have asked the Department 

of Energy to continue searching for information 

where none was provided in the initial request. And 

primarily this has been for the atomic weapons 

employer facilities, and the 21 requests that you 

see listed in the first quarter depict this type of 

secondary request. And since that time we've worked 

with DOE to establish what information they have and 

we captured the bulk of the information on the 

AWE's. We're continuing the process of gathering 

information on the AWE's as best we can. 
 

 In other cases we're seeking general 

information such as the limit of detection for a 

historical dosimetry practice, and this general 

information will assist the specific claim in 

question, as well as fulfill the site profile 

information for the benefit of all claims relevant 

to that site and that time period. And another 

example of secondary information that might be 

requested would be coworkers dosimetry data. 

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 Once we have assembled and reviewed all 

relevant information from NIOSH records and received 

and examined the information from the Department of 

Energy, we schedule the interview with the claimant. 

 As of today we've conducted 55 interviews. We have 

scheduled another 51 interviews to be conducted 

during the next four weeks. We currently count 75 

dose reconstructions underway. And what we mean by 

this is we have received, we have assembled, 

evaluated and reviewed the readily-available 

information pertinent to a given claim. We have 

scheduled, and for 55 claims have conducted, the 

claimant interview. 

 For six claims we have completed the draft 

dose reconstruction report as specified in our rule 

42 CFR Part 82. The six draft reconstruction 

reports will be provided to the respective claimants 

next week, and that will be followed up by a phone 
40 call from the dose reconstructionist to explain the 

report, the process and the findings of the dose 

reconstruction. At that time we'll also seek the 

claimant's approval on the OCAS-1 form to close the 

dose reconstruction process and move the claim on to 

the Department of Labor for determination of 

probability of causation. 

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 The number of phone calls that we've 

received in the Office of Compensation Analysis and 

Support have increased substantially each quarter as 

we handle more and more claims. Of these 1,454 

calls received, 140 calls have been for general 

information on the program. They were not related 

to any specific claim. The remaining 1,324 calls 

that we have received were regarding a specific 

claim and these calls were actually only relevant to 

679 claims, or approximately one-fifth of the 3,634 

claims we have in hand. For these 679 claims, the 

number of calls range from one to 20. 

 The inquiries that we received during the 

phone calls seemed to center on essentially three 

questions: What's the status of my claim? Do you 

have my dose from DOE yet? And when will you 

schedule my interview? With regard to visitors at 

OCAS, we've only had one. 

 And I thank you for your attention. I'll 

answer any questions that you may have at this 
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 41 point. 

 MR. GRIFFON: Larry, I'm just curious. You 

said -- mentioned several times that you're working 

with DOE to obtain more information, and in previous 

meetings you mentioned the memorandum of 

understanding, and I wonder if there's been any 

formalized MOU put out between the agencies 

regarding access to data for this. 

 MR. ELLIOTT: No. As I mentioned just a 

moment ago, we're working on the language. We're 

negotiating the various points I identified, so 

that's not available at this time. 

 MR. GRIFFON: Okay. Just the only concern I 

would have is that some of the things that you 

mentioned as -- you mentioned that you reviewed and 

evaluated based on readily-available information, 

and in another part you mentioned that some of the 

secondary information requests such as general 

bioassay program information -- I might view some of 

that as almost as important as the personal 

dosimetry records in piecing this all together. And 

the site profiles that you're doing I think are as 

important to get started early as getting the 

individual's personal information. Otherwise, you 

may be in a position where you're going back and 

revisiting claims after you've rejected them 

possibly or that sort of scenario may arise, so I 
42 would just point that out, that I think some of the 

other information may give you a different 

perspective on the personal data files. 

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 MR. ELLIOTT: I appreciate your comment, but 

I would ask you to keep in mind that we're not 

finalizing a dose reconstruction on the claim until 

we're satisfied we understand all of the information 

that we need and we have all that information, 

whether it's the individual's dose or it's the 

secondary level of information to better understand 

how we reconstruct that dose. And so the claim 

doesn't move forward until we have that. And we are 

building both site-based profiles and individual 

dose files as we proceed. They go on concurrently. 

 DR. ZIEMER: Larry, under the legislation 

itself, it's true is it not that DOE in fact is 

obligated to provide such information to NIOSH so 

that the function of the memorandum of understanding 

is mainly to make that a more smooth and wellunderstood process? I mean -- 

 MR. ELLIOTT: Yes. 

 DR. ZIEMER: -- it doesn't prevent the 

information from coming, but what will we gain from 

the MOU that isn't already in the legislation? 

 MR. ELLIOTT: Well, the MOU language will 

address access to the information, the fact that we 

can go in and look at National Security-based 
4 information and seek declassification or redaction 

of information pertinent to a given claim, that we 

can get DOE's certification or verification that 

there is -- they've searched all available 

information and there is no more to give. These are 

the collaborative relationships that will be 

established in the MOU. 

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 DR. ANDRADE: A comment and then a quick 

question for clarification. Being from a DOE site I 

know that we've been sending information for months, 

so it's not that information is not flowing. That's 

my comment. 

 Number two is a quick question for 

clarification. On the sheet before you examples of 

communications to claimants there is an acronym. On 

number four it says summary of CATI report to 

claimant letter. Can you explain what that is? 

 MR. ELLIOTT: Computer-assisted telephone 

interview. 

 DR. ANDRADE: Okay. 

 MR. ELLIOTT: That's a CATI. 

 DR. ANDRADE: Thank you. 

 MR. ELLIOTT: I apologize for -- we run in a 

sea of acronyms. We don't always realize that 

everybody else doesn't have the same definitions we 

do. 

 DR. MELIUS: I don't know if you're going to 
talk specifically about these letters and these 

communications here, but I really think someone 

should take another look at them or provide some 

supplemental information 'cause some of these are 

pretty technical. I don't know if most claimants 

are going to understand what a dose reconstruction 

is and terms like that. It seems that it's awfully 

-- a little bit too technical and doesn't really 

explain -- it's going to confuse people, and 

particularly the -- you didn't include the sign-off 

they do at the end to say they accept your dose 

reconstruction, but that letter I think really needs 

to be very clearly worded and communicated to people 

'cause that's -- 

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 MR. ELLIOTT: We agree. 

 DR. MELIUS: -- got important implications, 

but -- 

 MR. ELLIOTT: We agree. 

 DR. MELIUS: -- someone needs to go back 

through these letters I think and really look at 

them, you know, in terms of reading levels and 

things like that. 

 MR. ELLIOTT: I appreciate the comment and 

we do agree. And I would say this, that -- keep in 

mind, throughout this process we're having multiple 

contacts with the claimant, and each contact we're 

providing explanation. We're trying to educate them 
4 along the way. The first letter that goes out has 

our brochure with it that talks about the program, 

but we also provide a fact sheet that talks about 

dose reconstruction in lay terms and tries to give 

them an insight in that. And no, you don't have a 

copy of the letter that sends the dose -- draft dose 

reconstruction report and the OCAS-1 form in your 

packet. We're working on those now as I speak. I 

have a health communication specialist who's working 

up the language in those and we're reviewing dose 

reconstructions -- 

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 DR. MELIUS: Yeah, just one comment. I 

think we always tend to sort of over-estimate our 

ability to communicate and expect that people will 

have read everything that we sent them before and 

that they'll understand it, and so the next letter 

is going to be readily understandable and that's not 

how -- 

 MR. ELLIOTT: No, it's not how it works. 

 DR. MELIUS: -- they're very nervous, 

anxious about this. Many of them -- limited 

education and difficulty understanding. And I think 

having the ability to call you and so forth is 

important, but I also think it's as important that 

they have something clear in writing that they can 

share with someone to help them understand it -- 

 MR. ELLIOTT: Sure. 
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 DR. MELIUS: 46 -- and so forth. 

 MR. ELLIOTT: Sure. 

 DR. ZIEMER: Might I ask, the brochure that 

you're talking about is sort of a layman's type 

brochure -- 

 MR. ELLIOTT: Yes. 

 DR. ZIEMER: -- is it not, and did the Board 

get copies of that? 

 MR. ELLIOTT: We don't have that to you yet. 

 We're -- 

 DR. ZIEMER: I think it might be important 

to see that, simply -- that might alleviate some of 

the concerns in terms of knowing how well that does 

the job of laying out in lay terms what a dose 

reconstruction is about, and then the letter simply 

is a more -- 

 MR. ELLIOTT: Sure. 

 DR. ZIEMER: -- formal document. But the 

comments certainly are well-taken. We had one over 

here -- Roy? 

 DR. DEHART: When you were discussing the 

memorandum of understanding with DOL -- Department 

of Energy -- is there not a requirement in there to 

deliver information within a certain number of days, 

which becomes a performance criteria? 

 MR. ELLIOTT: Well, we're working with the 

Department of Energy to have that language placed in 
47 the MOU, yes. There is -- there is an intent from 

our perspective to have suspense dates. Currently 

our letters that go to the Department of Energy 

sites specify a response back to us within 60 days, 

and that means -- the way that request is phrased, 

if you don't find the information, we still want to 

hear back from you in 60 days on the status of your 

progress. If you do have the information, we would 

like to have it within 60 days. 

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 DR. DEHART: The reason I asked the 

question, that would appear to be a metric that we 

might want to look at as we move forward with this. 

 MR. ELLIOTT: Thank you. 

 DR. ZIEMER: No other comments or questions? 

 Okay, thank you. 

 Next -- oh, we do have a comment. Jim? 

 DR. MELIUS: Yeah, the dose reconstruction 

contract, I think you just said it was going to be 

awarded in June now? 

 MR. ELLIOTT: June, we hope. 

 DR. MELIUS: Huh? 

 MR. ELLIOTT: June, we hope. 

 DR. MELIUS: Okay. 

 MR. ELLIOTT: Next month. 

 DR. MELIUS: So where would that leave you 

in terms of between now and then being able to 

process claims? 
 MR. ELLIOTT: Well, we have 51 interviews 

scheduled. I can't predict how many dose -- draft 

dose reconstructions we're going to finish and get 

in the hands of the claimants in the next four 

weeks, but we have 75 underway, so each week -- each 

week I'm sure we're going to complete dose 

reconstructions. We'll send the draft reports out. 

 But I am not in a position to predict at this time 

how many we're going to complete before the award. 

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 DR. MELIUS: What is the delay in awarding 

that contract? 

 MR. ELLIOTT: Well, there's -- it's a 

competitive process and there are audits that are 

being performed on the proposed proposers to the 

award. That takes time. We've had an unfortunate 

death in our procurement office which I'm not sure 

has delayed us too much, but it certainly has slowed 

things down for that one week where we all reacted 

to that. And we have a series of questions that 

we're posing back to the individual proposers on 

certain issues, and so -- we're moving as fast as we 

possibly can trying to put this in place. 

 DR. MELIUS: One question, as long as -- I 

believe at the last meeting you mentioned that the 

proposers were supposed to prepare a conflict of 

interest -- 

 MR. ELLIOTT: Plan. 
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 DR. MELIUS: 49 -- plan. 

 MR. ELLIOTT: Yes, sir. 

 DR. MELIUS: Is that part of what's -- the 

going back and forth now or is that -- have they 

done that satisfactorily? 

 MR. ELLIOTT: I can't comment on that. 

 DR. MELIUS: Okay. 

 DR. ZIEMER: Thank you. Then we'll move 

ahead to the next item on the agenda, which is the 

summary of the changes in the probability of 

causation rule. This basically is a report on the 

final rule, which incidentally hits the street 

today, I believe, in the Federal Register, and the 

final rule would include the -- dealing with not 

only this Board's comments but other input that the 

staff have received, so Ted Katz is going to take us 

through that. Ted? 

 MR. KATZ: Hi, thank you. One second while 

we get on board here. 

 So this is going to be a very brief summary 

of changes and how we got there. I understand you 

can actually buy the Federal Register at the news 

stand in Washington, so I don't know if any of you 

ran out and purchased your own copy, but let me just 

talk a little bit about public comments first. 

 We had 12 organizations and 24 individuals 

comment. The organizations included labor 
organizations, community organizations, one big 

university system and then, again, 24 individuals. 

The comments were diverse, very diverse. There's 

really no massing of public opinion in any one area 

and pertaining to any particular provisions of these 

rules. In most cases we say -- you'll see through 

out the rule we say several commenters, and that 

really -- everything was several commenters, and 

really we're talking about, in most cases, two 

commenters said this, two commenters said that. 

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 I'm going to just run through -- give you a 

sort of flavor for the comments we received. There 

were a lot of comments. I mean not many commenters, 

but lots of comments. I can't really capture them 

in any perfect way, but we had a number of comments, 

and this is probably one of the comments areas that 

was most numerous about peer review. There was 

much interest, questions about how IREP would be 

peer-reviewed, has been peer-reviewed. And likewise 

in the updating of NIOSH-IREP what sort of peer 

review would occur. 

 We also had a number of comments -- this is 

probably the most prevalent area -- relating to 

chemical cancer risks and how those would be 

attended. Really sort of three different ideas out 

there. One idea is how are we going to address 

occupational chemical carcinogens, are we going to 
5 account for their risk as well. And then a second 

sort of comment relating to chemical risks is how 

are we going to address -- are we going to address 

the risk interaction between occupational chemical 

carcinogens and radiation. And then a third asking 

about how are we going to address, if we're going to 

address community non-occupational chemical 

carcinogen exposures and how that might affect, you 

know, the background risk for an individual for 

cancer. 

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 Had a number of comments about the 

application of -- or really one I think actually 

here, the application of NIOSH-IREP updates. As you 

know, with progress in science, we intend to improve 

NIOSH-IREP down the road and we've laid out in the 

rule a number of areas in which we would do that. 

The comment here pertains to what would we do about 

claims that have already been adjudicated based on 

what would in effect then be the old NIOSH-IREP. 

 Documentation of NIOSH-IREP. There was some 

interest in how much documentation would there be of 

NIOSH-IREP. Is this going to be a black box or do 

people get to see what the assumptions and formula 

are that produce the results that come out of NIOSHIREP. 

 And similarly the interest in the 

probability of causation calculations themselves, 
what sort of documentation would be going to the 

claimant explaining, again, these assumptions and 

formula underlying the results that they receive. 

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 Then we also had a large number of comments 

about really the specifics of NIOSH-IREP, the 

formula in there, the risk models, comments such as 

-- or questions as to whether it's appropriate to 

use the data from studies of the Japanese 

population, comments on both sides of the fence as 

to whether our plans for adjusting for smoking in 

risk calculations is appropriate -- either too high 

or too low. And a variety of comments that actually 

were presented to you in previous Board meetings, 

too, about the content of NIOSH-IREP. 

 And then we had a number of sort of 

theoretical and statutory-related comments, as well. 

 For example, here one commenter is interested in -- 

in the literature out there there's proposals that 

compensation should be done rather than in an all or 

none sense where if you pass a certain threshold of 

probability of causation, you're compensated; if you 

don't, you're not -- that compensation should be 

done proportionally, proportionate to the 

probability of causation. This was a comment. 

 Another comment or a question about whether 

we should be establishing a radiation dose threshold 

for doing probability of causation calculations, and 
the concern here was a concern that you've all 

addressed and discussed to some extent, rare cancers 

and whether uncertainty is a problem for rare 

cancers and hence might be addressed by using a 

radiation dose threshold. And on the other side of 

that same issue, we also received a comment 

suggesting that rare cancers should be presumed to 

be radiation-related. 

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 And then comments as well about the 

relationship between the Regulatory Radiation 

Protection Standards, ICRP standards used for 

radiation protection and their use of those models 

for calculating probability of causation, whether 

those should be in sync or not. 

 Now this is just to be complete. I know you 

know what you did and I don't need to tell you what 

you did, but the Board made a recommendation as 

well, which was to formalize or incorporate what was 

previously in the preamble and has always been our 

intent, the role of the Board in reviewing NIOSH 

updates of the NIOSH-IREP program as we incorporate 

new models and so on. And the Board also asked that 

the public have opportunity for review and comment 

in those instances. 

 How did we actually change the final rule. 

We spent a lot of time, and these are reflected in 

the preamble of the rule addressing the public 
comments. The actual change is really two 

substantial areas of change in the rule. One we 

added provisions as the Board recommended, bring 

from the preamble into the rule itself provisions 

for updating NIOSH-IREP, and we also added a 

provision to allow NIOSH to update NIOSH-IREP to 

address chemical-radiation risk interactions. 

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 Let me tell you a little bit more about 

these. For updating NIOSH-IREP, the Board and the 

public have the opportunity for input on the front 

end, to make recommendations as to changes that 

ought to be done to NIOSH-IREP, as well as there are 

really extensive provisions for notice, opportunity 

for review and comment before any changes would be 

made, both by the public and by the Board. And then 

of course full notice of when changes are actually 

made. 

 And with chemical-radiation risk 

interaction, this is -- here we're talking about of 

course -- I've told you sort of three areas of 

comment, but this relates to occupational exposures 

to chemicals. And this was an issue that was 

discussed when we were drafting the rule and we 

concluded -- it was raised again in public comments, 

which is why we ended up addressing it here. At the 

time we were drafting the rule, we fairly firmly 

concluded that the science wouldn't support doing 
this at this point. And as well, and perhaps 

practically more important, that it's practically an 

enormous problem to address chemicals in probability 

of causation calculations and that's because the 

Department of Labor already has really an enormous 

burden of data collection to be able to make this 

adjudication process work, and this would be 

throwing into it a very sizeable new burden on top 

of what they're already trying to achieve. And for 

producing timely decisions, this would be very 

difficult. But we've included it anyway. We've 

included -- with the understanding that the world 

can change and at some point in the future we may be 

able to both scientifically and practically address 

chemical-radiation risk interaction. 

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 Let me just conclude then. The bulk of the 

comments we received regarded really implementation 

issues on the one hand, and those are going to be 

extremely useful to us in thinking about updating 

NIOSH-IREP and so on since we got a lot of comments 

on the details of NIOSH-IREP, and also have helped 

us in thinking about how we work with the claimant, 

where we got a lot of comments. 

 And then there were a lot of comments that 

really relate to statutory requirements, and those 

-- those issues are really issues for Congress, as 

we explained in the preamble and addressed in these 
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 There was substantially silence on a lot of 

substantive policy issues or policy decisions 

included in these -- how we use IREP in this 

program, how we address multiple cancers, how we 

address secondary cancers -- a lot of substantive 

issues, commenters were silent. And that is 

encouraging for us. We think that we may have 

gotten it right if there wasn't a lot of 

consternation about these approaches. 

 And then finally I'd just like to say we're 

now faced with the very big job ahead of helping DOL 

to implement these. We've recently -- Russ Henshaw, 

who you'll hear from later, has been traveling 

around the country working with DOL to get them 

prepared to apply these guidelines, but we realize 

there's going to be a lot of work to do to make this 

program work smoothly in the future. 

 And that concludes my presentation. I'll be 

happy to take questions. 

 DR. ZIEMER: Thank you, Ted, and just for 

the Board, let me mention that in the draft -- well, 

it's the final version, but our copy of the final 

version which begins right after Ted's overheads in 

your packet, the section on the public comments 

begins on page 22. It summarizes what Ted has given 

us in the slide version here and goes through the 
various categories of comments and how they were 

handled. And then beginning on page 56 of that 

draft it has a section on the recommendations of 

this Board and the response of staff to those 

recommendations. Basically it's only the third 

recommendation that required a particular response, 

and that was the one dealing with moving into the 

body of the rule the issue of how the rule or how 

the models are amended and the issue of the public 

input on that and that sort of -- 

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 MR. KATZ: That's correct. 

 DR. ZIEMER: Now let me see if there are 

questions or additional comments. Yes, Mark? 

 MR. GRIFFON: Just a quick question, Ted, 

and this might be more appropriate later, so if 

they're going to cover it later -- Mary and Russ -- 

you can tell me. But the DDREF value, if I'm 

reading this right, NIOSH has made a decision to 

slightly modify that to lower it to -- 

 MR. KATZ: Mary let -- 

 MR. GRIFFON: -- more toward unity? 

 MR. KATZ: That is actually a good issue to 

let Mary address. 

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

that. Is that agreeable, Mark? Okay. Roy? 

 DR. DEHART: Realizing that this is not a 

regulation but a rule, is it subject to Federal 
58 litigation? And if so, is there any suggestion that 

someone may take this to court? 

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 MR. KATZ: Is there any suggestion? I mean 

this is a rule -- this is a regulation and it is 

subject to litigation, and I think most regulations 

with real substance to them end up being litigated 

at some point on some basis. I mean it's hard to 

know. I think we expect there may be some 

litigation here as -- we don't know, you know, from 

what quarter it's going to come on what basis, but 

these rules mean a lot for a lot of people, so -- 

 DR. DEHART: That could indicate there would 

be delay then, if it went to the court. 

 MR. KATZ: Well, I mean they're -- you mean 

a stay of the rules? 

 DR. DEHART: Yes, that or other -- 

 MR. KATZ: This is really sort of out of my 

terrain, but we don't have any indication that 

anyone is planning to stop the rules now from going 

into effect. I think people are anxious to actually 

see us implementing these rules. 

 DR. ZIEMER: Are there other comments or 

questions for Ted? 

 MS. GADOLA: I have a comment, and it's also 

a question. You mentioned about the possibility of 

more scientific information being available about 

the synergistic effects of chemical carcinogens and 
5 ionizing radiation, and reading this you said that 

you did not have the scientific evidence to support 

a change in IREP at this time. How would that 

affect future cases? 

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 MR. KATZ: So if down the road we were to be 

able to address chemical-radiation risk interactions 

for future cases, we would do that. Is that what 

you're asking or are you asking -- 

 MS. GADOLA: Well, you said that in the 

future, and the way the rule is written now, how 

would that allow future information to be 

introduced? 

 MR. KATZ: The rule allows us to update 

NIOSH-IREP to take into account improvements that we 

can make, and we had previously, in the proposed 

rule, iterated a number of areas in which NIOSH-IREP 

-- we may be working on NIOSH-IREP in the future. 

And what we did in this case was add another area in 

which we may be able to improve NIOSH-IREP in the 

future. And if at such time as we can do that, we 

do that, then claims following that would be 

adjudicated with a NIOSH-IREP that takes into 

account those interactions. Is that getting to 

your -- 

 MS. GADOLA: That helps. 

 MR. KATZ: -- or am I missing -- 

 MS. GADOLA: I think my concern, along with 
a lot of others that probably made comments about 

this, is that the history shows that a lot of the 

people that develop certain types of cancers also 

worked with chemicals that have been suspected or 

labeled as carcinogens, and there's a possibility 

that the radiation dose may not substantiate that 

their cancer was caused by radiation. But because 

there is a high number of those cases and because 

they worked with chemicals, a lot of scientists 

suspect that it was a synergistic effect of both the 

chemicals and the ionized radiation. And I was just 

wondering how much of that will be dealt with in the 

future as more science is available. 

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 MR. KATZ: That really -- it relies on two 

things, both science progressing far enough that you 

could address those issues, and second, as I noted, 

there's a practical concern, completely aside from 

the science, which is how would DOL be able to 

obtain sufficient information for all these claims 

to be able to make use of such information, even if 

the science told us how to. So there are really two 

issues in the way of actually implementing changes 

to NIOSH-IREP related to chemical-radiation risk 

interaction. 

 MS. GADOLA: I know that also some of these 

claims then also go to the states' workers comp 

programs, but in the past, anytime claimants have 
61 tried to do this it's been very, very rare that they 

were awarded anything. So I know this is not 

particularly what this deals with, but I think it is 

something that's important when we look at the whole 

picture. 

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 MR. KATZ: And there is -- just to note, 

there is another provision of EEOICPA, of this law, 

that addresses assisting claimants with state 

workers comp claims, and that's certainly an issue 

that they're going to face with those claims as 

people were exposed both to chemical carcinogens and 

radiation. 

 MS. GADOLA: Thank you. 

 MR. KATZ: You're welcome. 

 DR. ZIEMER: Ted, is there anything in the 

law that would prevent a worker from going back, 

once there is new scientific information -- someone 

whose claim had been turned down on the basis of 

radiation exposure alone could go back later, could 

they not, if there was -- 

 MR. KATZ: Let me -- 

 DR. ZIEMER: -- some additional scientific 

information on the chemical aspect? 

 MR. KATZ: Right, there's -- there are two 

provisions that are relevant here. The science that 

probably doesn't move fast enough for claimants, so 

claimants have a year to go back to DOL on a denied 
claim, but DOL, foreseeing issues like this, new 

information, has a provision in their rule that also 

allows them to reopen a claim at any time -- for 

example, on the basis of new information, progress 

in science -- and so this is something DOL has 

foreseen as an issue and addressed in their rule. 

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 DR. MELIUS: Yeah, seems to me that in doing 

this rule you've done two things. You've finalized 

the regulation and made some procedural changes. At 

the same time you're also making changes in the 

NIOSH-IREP, or making some adjustments in that, and 

those are really covered in the preamble more than 

they're covered in the rule. And my question is, 

how -- what are going to be the criteria for what 

are major changes in the NIOSH-IREP and how are you 

going to -- what's the procedure going to be for -- 

or the threshold for alerting the committee to that 

-- 

 MR. KATZ: Right. 

 DR. MELIUS: -- and the public and sort of 

the procedure for that 'cause it seems to me that 

when I'm reading over this regu-- I'm paying -- 

focusing on one thing, the IREP, when you're -- in 

their preamble, and then procedural issues in your 

regulation, and we've had this going on in sort of a 

parallel track. 

 MR. KATZ: Yeah, this is actually -- I think 
this is addressed, and in effect you will see any 

change to NIOSH-IREP that has a substantive effect 

on people's -- on calculations of probability of 

causation. Now there may be changes that we make to 

NIOSH-IREP that don't have a bearing on that but 

that make it more user-friendly for Department of 

Labor and so on, all sorts of things. We're going 

to be improving the documentation that's available 

through NIOSH-IREP, so there'll be a number of 

changes to NIOSH-IREP that don't need, I think, to 

be vetted. But wherever they have a bearing on 

probability of causation findings, you will see 

those changes as proposed changes first, and have an 

opportunity for review. 

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 DR. ZIEMER: Okay. Are there further 

comments or questions? There appear to be none, so 

we will take a break at this time and reconvene at 

whenever it says on the agenda, which is what -- 

10:15. Thank you. 

 MR. KATZ: Thanks. 

 (Whereupon, a recess was taken.) 

 DR. ZIEMER: Before we call on Ted to give 

us the presentation on part 82 rule, I'd like to 

call attention to the fact that we did receive a 

response from Secretary Thompson on our comments 

that had been sent to him earlier. In case you 

hadn't noticed, his response is in the insert -- 
what do you call it, the inner cover, I guess, of 

your Board book this time. And for the general 

public, there's a copy of Tommy Thompson's letter to 

the Board on the rear table back there. 

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 The other thing, again before Ted begins, we 

delayed introducing others who are with us today. 

I'd like to take a moment -- Larry, if we could 

introduce any of the other NIOSH staff that are here 

besides Ted, and of course we've already heard from 

Dr. Rest earlier today, but are there some other 

NIOSH staff we might just identify for members of 

the public, as well as for the Board? 

 MR. ELLIOTT: Certainly. We have Tracy 

Gilbertson, who's a technical information specialist 

on staff, back in the corner there. Russ Henshaw I 

think you met at a meeting before. I don't see him 

in the room right now. Then we have office of the 

general counsel who's assigned to NIOSH over on this 

side of the room with Mary Armstrong, Alice Kelley 

and Liz Homoki-Titus. I think that's all the NIOSH 

-- oh, Jim Neton is here, and you all know Jim. And 

I think that's all of us. 

 DR. ZIEMER: Thank you. We also like to 

both welcome and have introduced to us our visitors 

from either other agencies or representing other 

groups or private individuals, members of the 

public. And I'd like to ask those who are here as 
65 members of the public, observers and representatives 

of other agencies if you would please introduce 

yourself to us. Just give us your name and who you 

are representing. There's a mike here and you can 

use that. Please, we'd like to welcome all of you. 

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 MR. BLANKENSHIP: Jim Blankenship for the 

Department of Labor. 

 MR. EAGAN: Jeff Eagan, Department of 

Management. 

 MR. SLOCOMB: Jeff Slocomb, Department of 

(inaudible). 

 DR. ZIEMER: We have (inaudible) signing in 

from EPA. Consider yourselves all introduced. 

 Let's proceed with the next item on the 

agenda, the dose reconstruction final rule, Ted 

Katz. 

 MR. KATZ: Hi again. Bad penny here. So 

I'm going to run through this rule as I did the 

other, quickly. This time we had 13 organizations 

and 23 individuals, so one organization added and 

one individual dropped out. And the comments in 

this case really covered all aspects of the rule -- 

all aspects of the rule, really. And in many cases, 

all sides of an issue, so it was sort of very 

thorough vetting, I think, in this case of this 

rule. Maybe the dose reconstruction rule is just 

friendlier material for the public, or I don't know, 
66 but -- and give you a flavor for these comments, if 

I can make this move. 

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 We had comments about feasibility, precision 

and reliability -- you know, whether we can do dose 

reconstructions, how precise is precise enough and 

how good is the information that we're basing the 

dose reconstructions on. 

 Comments on both sides of the issue with 

respect to efficiency measures. Some commenters 

thought this was absolutely the way to go, the only 

way to go. And others raised concerns about what 

implications that might have using the efficiency 

measures in terms of litigation that might occur 

down the road and so on, since the government's 

producing these estimates. 

 We had comments -- numerous comments about 

the role of claimants, again on both sides of the 

issue. Some were concerned that claimants were 

being overly burdened or might be overly burdened. 

And on the other side, suggesting that claimants 

should be as fully involved as possible -- something 

I hope we've achieved. 

 Comments about the scope of covered 

exposures, comments in really three areas -- X-rays, 

the use of X-rays as part of the dose, and there I'm 

talking about medical screening X-rays that are 

required for employment -- as a condition of 
employment. Also whether chemicals should be 

covered, chemical exposures to occupational 

carcinogens should be covered, and whether we should 

be accounting for non-occupational exposures to 

radiation as well. 

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 Then we had, similar to the probability of 

causation model issues, concerns about using ICRP 

models other than those that are used for radiation 

protection programs in the United States. 

 Also had a comment -- or several comments 

about use of the dose of record. That's the dose of 

record produced by DOE, how those would be used in 

this program. 

 Comments about updating the scientific 

elements. Here in particular there's a concern -- 

and this again sort of parallels the probability of 

causation guidelines. As we update scientific 

elements, what about claims that were already 

adjudicated. Well, we've already completed the dose 

reconstruction. What would we do about those. 

 Comments about the involvement of DOE, in 

particular whether DOE should be a reviewer at 

different stages of a dose reconstruction. 

 And comments about oversight and peer 

review, similar to the probability of causation rule 

comments, and specifically about the roles of the 

Board in providing such oversight, whether that role 
68 of the Board should be prescribed in the regulation 

and comments as to what the extent of technical 

capacity of the Board is to serve as providing 

oversight and as peer-review source for NIOSH. 

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 The Board -- you -- provided a number of 

comments on this rule. A parallel comment to the 

probability of causation rule to incorporate the 

Board as a peer reviewer of scientific updates and 

to involve the public in that process as well. And 

you also identified a number of provisions that 

needed to be clarified. I've listed them here -- 

application of the Privacy Act -- we've simplified 

that so that's clear -- to dose reconstruction 

records. The procedure for NIOSH to conclude a dose 

reconstruction; here you were concerned about 

ensuring that the claimant would have sufficient 

time -- always be afforded sufficient time to 

provide additional information that the OCAS-I form 

that we ask them to sign at the conclusion of dose 

reconstruction, that they have -- there's a time 

limit on that, but that that time limit not be 

applied while they're still in the process of 

obtaining additional information they believe is 

relevant to their dose reconstruction. And you 

wanted us to clarify that we would be using current 

ICRP models. 

 How did we change the rule? We added a 
69 process for updating methods, along the lines we did 

for the probability of causation rule, providing 

full opportunity for public input, as well as Board 

input in what ought to be changed, as well as review 

and comment as we propose changes and pursue them, 

as well as notification when changes are 

implemented. 

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 We added a provision allowing NIOSH to 

review completed dose reconstructions on its own 

initiative. This relates directly to the comment 

we'd received, so what will we do in cases where 

we've updated our methods for dose reconstructions 

that were completed and used by DOL in adjudication 

and the claim was denied. So we wanted to have the 

ability to revisit those dose reconstructions using 

the new methods. 

 We clarified the process involving the 

claimant in a number of ways, clarified that the 

interviews we would conduct with them could be 

iterative and involve a number of sessions. This 

wasn't a one-opportunity, one day to speak to NIOSH 

and then we close the door. And clarified the 

process of concluding the dose reconstruction, as I 

mentioned earlier, so that the claimant is assured 

the time they need to provide information they're 

seeking related to their dose reconstruction. 

 And we clarified our potential use of all 
relevant types of information. We had, in the 

section specifying what sorts of information we 

would apply to dose reconstructions before, written 

the list as if they were conclusive lists, so we 

have added basically provisos to each of those that 

we would use other information that was relevant, 

that we may not -- may not have occurred to us in 

preparing that list, nor did we try really to be 

comprehensive in those lists, but to make it clear 

that we would be making use of all information that 

is relevant in producing these dose reconstructions. 

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 We also -- we clarified, as the Board 

recommended, that we would be using current ICRP 

models. 

 We removed Table 1. Table 1 included -- 

specified the ICRP radiation weighting factors, 

current -- those current weighting factors. A 

commenter rightly indicated that if we had that 

table in there, then we would have to change the 

regulation to make use of any update that ICRP did, 

and we didn't want to be in that position so we 

removed the table and made it clear that we would be 

using the current factors, whatever they might be. 

 We clarified, as you recommended, the 

Privacy Act application to availability of dose 

reconstruction records to the public. 

 And we clarified a variety of other 
procedures as well -- how we would worst-case 

assumptions, how and when, information to interpret 

bio-monitoring data, particularly old bio-monitoring 

data that may have substantial limitations and so 

on. 

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 And in conclusion, the comments were really 

remarkably balanced on various sides of every issue. 

 Many issues, many comments, really, related to -- 

again to implementation issues and will be useful to 

us as we go forward in building a better program 

continually. And very clear from the comments from 

claimants and others that we have a very large 

educational task at hand, both to educate the 

claimants about our dose reconstruction process and 

also a lot of learning to do ourselves in how to do 

this well. 

 And that concludes my prepared remarks. I'm 

happy to -- 

 DR. ZIEMER: Thank you very much, Ted. 

Before we have comments, I'd like to call attention 

to the fact that you have HHS news bulletin that's 

hot off the press that indicates the publication 

today of the two -- is this for -- both rules 

covered here? Yes, part 81 and part 82. You have 

the text of part 82 that was submitted and which 

apparently now is available in its Code of Federal 

Regulations form, but you have the text as it was 
submitted as almost an insert in your booklet. I 

don't believe that this one is even punched, it's so 

fresh off the press, as it were. 

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 And the discussion on the dealing with the 

public comments that Ted has just summarized begins 

on page 13 of the text that the Board has, and the 

issues that were raised -- that is the 

recommendations of this Board and their resolution 

-- begins on page 63 of that text, in case you wish 

to look at that directly. In this case the Board 

had a number of comments. Ted has summarized them 

well and they indicate in detail here how each of 

the comments of this Board -- how each was handled. 

 Now let's ask if there are questions or 

comments that you have for Ted. Who's first, who's 

second? Mark looks like he's raring to say 

something, but he's hesitating. 

 MR. GRIFFON: I just have a similar request 

as was made earlier on the minutes, that we just -- 

you know, we just came in and saw these and I'm 

thumbing through it as fast as I can, and I'm not 

sure -- probably my questions will be held off for 

Jim Neton anyway, but can we have a few minutes just 

to thumb through -- 

 DR. ZIEMER: Right, but you recognize that 

the rule now has been published. We're not in a 

position to recommend any changes in the rule. We 
7 went through the rule -- that is the draft rule -- 

in great detail at our previous meetings, so what 

Ted has summarized really is what the final rule 

looks like compared to the earlier versions, where 

they have added detail, where they have changed 

things and so on. But we certainly -- if you -- let 

me do this. Let's wait and try to stay on schedule. 

 These are pretty lengthy and I think it would not 

be appropriate right now to sit and take time to 

read these, but there will be an opportunity later 

in the meeting if we need to spend a little time 

just looking at the changes and making sure the 

comfort zone is pretty good. But recognize that in 

this process, as they go through the rule-making, 

there's really not a practical way to come back to 

the Board every time they respond to a comment. 

They've tried to, on balance, deal with all 

comments, from us and from others. But the Board 

does not have the final say on this. We are -- we 

recommend things, just as others do. 

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 DR. MELIUS: Yeah, but -- 

 DR. ZIEMER: And they are responsive, right. 

 DR. MELIUS: Just to follow up on that, I 

think that it is appropriate for the Board to ask 

for clarification on these issues to try to 

understand it better. 

 DR. ZIEMER: Right. 
 DR. MELIUS: 7 I guess my question -- is Ted 

going to be here tomorrow, so -- 

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 MR. KATZ: Yes. 

 DR. MELIUS: Okay. So there is an 

opportunity -- 

 MR. KATZ: Yes, I was going to suggest that, 

actually. I'll be here tomorrow and I'll be happy 

to -- 

 DR. ZIEMER: Yeah, and perhaps an 

opportunity after you look it over to raise issues 

about how things are going to work and how they're 

going to be dealt with. This is basically sort of 

an overview of the changes as they appear in the 

final rule. 

 Okay. Henry's next. 

 MR. KATZ: Yes. 

 DR. ANDERSON: Yeah, my comments more are 

your implementation issues and to kind of put on the 

list for subsequent meetings. I think it'd be very 

helpful to maybe have a discussion of the specifics 

on what the recommendations or concerns people had 

about implementation as we move forward. As you 

say, the rules are fixed and now we're into how are 

they going to be applied and what are the potential 

problems, so I would think if we have an 

implementation discussion of -- I don't know if 

they're specifically listed here or not, but what 
the public comments were that you found would be 

helpful to you, it'd be helpful I think to us to 

also know what those comments were and have a 

discussion on so how are we going to address those 

issues in the future. So just put it on the parking 

list. 

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 DR. ZIEMER: And you may want to take the 

time later to go through those sections that I 

identified where each of the categories of comments 

were raised and the discussion on how they addressed 

those. 

 The other thing is to keep in mind on 

implementation that under the rule-making, there are 

guidelines which will deal with the sort of more 

detailed implementation issues, and we looked at 

some of those before I think. 

 MR. KATZ: Right. 

 DR. ZIEMER: Yeah. Okay, other comments or 

questions? Thank you, Ted. 

 MR. KATZ: Thank you. 

 DR. ZIEMER: The committee is going to be -- 

or the Board will be addressed in a few moments, we 

hope, by Dr. Land. We're a little bit -- a few 

minutes ahead of schedule, so... 

 (Pause) 

 DR. ZIEMER: Just a comment here. Larry, 

yes? 
 MR. ELLIOTT: Well, we're trying to track 

down Dr. Land and make sure he's on his way here. 

We also have a little bit of a predicament with Mary 

Schubauer-Berigan being locked down in the airport 

in Cincinnati, not being able to get out due to 

weather. And so we're trying to figure out where 

these folks are at and what we can do about your 

agenda at this point, so if you'd bear with us. 

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 DR. ZIEMER: I'll just exercise the Chair's 

prerogative here. We'll take a break for about five 

minutes. That is a time break in terms of the 

action here, give Dr. Land an opportunity to arrive, 

and this would be a good time for you to do some 

reading on the final rules if you wish, or if you 

need to take a break already, you can do that. 

We'll just come to a brief standstill here for a few 

moments. Okay? Just give him a chance to get 

settled here a minute. 

 (Whereupon, a recess was taken.) 

 DR. ZIEMER: We're pleased to have Dr. 

Charles Land with us. Dr. Land is a statistician 

from the National Cancer Institutes, an individual 

whose expertise is very critical to the sorts of 

things that are being done here, and he will talk to 

us about the IREP program at NCI. Now there's -- 

well, I don't want to spend too much time myself, 

but there's IREP and then there's sort of IREP, Jr. 
77 or something, there's a NIOSH application of IREP. 

But we start out with the program as it was 

developed at NCI. So Dr. Land, we're pleased to 

have you with us today and welcome you to the 

Advisory Board activities here. 

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 DR. LAND: Thank you. Let's see, do I 

ask -- 

 DR. ZIEMER: Yeah, you have -- 

 DR. LAND: You haven't found it yet. Okay. 

 DR. ZIEMER: You have a -- 

 DR. LAND: It's also my talking notes, so if 

I don't look at you when I talk to you, you'll know 

why. 

 DR. ZIEMER: You will be able to advance 

them with the switch there. 

 DR. LAND: Okay, that's great -- good. 

 (Pause) 

 DR. LAND: Well, you can see that we have 

kind of a small group working on this, and maybe it 

wasn't a good idea actually to do it at all, but I 

decided that I really wanted to do it, so that's how 

we got to where we are. There's Ethel Gilbert and 

myself from NCI; Jim Smith from CDC, he has been 

more of an administrative advisor; and then Owen 

Hoffman, Iulian Apostoeai and Brian Thomas from our 

contractor, SENES Oak Ridge, which is your 

contractor, as well. 
 

 Well, the 1985 report was a response to a 

Congressional mandate, which was the Orphan Drug Act 

of something like 1983 or something like that. And 

the idea was that maybe the whole idea of making -- 

of claim adjustments, and maybe even legal stuff, 

could be based on the idea of probability of 

causation, which is just the excess risk divided by 

the baseline plus the excess, which is -- in 

epidemiological terms, it's the excess relative risk 

divided by one plus the excess relative risk as 

estimated from epidemiological data. 

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78

 And the 1985 report provided tables and 

algorithms for 13 cancers, and there were 

uncertainty analyses, but they were in a separate 

chapter. They were sort of -- I mean it was a 

serious attempt, but it should probably have been 

integrated. 

 The interesting thing is that the committee 

recognized that for X-rays really the relative 

biological effect of this was greater than one, but 

didn't have the data to do anything with it, so we 

just followed current practice and treated all low 

LET radiation as the same. And part of the mandate 

was periodic revisions. 

 Well, the Department of Veterans Affairs 

used it, has used it. They use it to adjudicate 

compensation claims for radiation-induced cancer. 
79 But they found the tables kind of hard to work with, 

and they commissioned CIRRPC to devise a screening 

approach based on the 1985 tables. And in effect, 

that -- the CIRRPC screening approach -- screened -- 

used the probability -- the uncertainty 

distributions. It screened out claims for which the 

upper 99 percent credibility limit or upper 

probability limit for the PC's was much less than 50 

percent. 

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 I don't think CIRRPC intended that that 

would be the rule, but that's actually the way it's 

turned out to be because after you've done that, 

well, then what else do you do? And it turns out 

there isn't that much information. 

 The Department of Defense has used it, the 

Navy has, and then of course now there is this 

Energy Employees Occupational Illness Compensation 

Act of 2000. 

 And the reasons for the update. Well, the 

-- mainly because the VA wanted us to do it. And 

the 1985 tables report was outmoded. It was based 

largely on 1980 BEIR's III report. Of course since 

there there've been new data, longer follow-up, and 

especially new A-bomb survivor dosimetry, which have 

changed the estimates somewhat; and also the 

development of the RERF -- the Radiation Effects 

Research Foundation -- Tumor Registry into something 
that you can really use, comprehensive incidence 

data. And if you're going to estimate risk, 

incidents are -- incidence data are better because 

the data are more accurate and they're more timely, 

also. 

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 New inferences have been made. Of course 

there's -- a great one is the methodological 

advances which take advantage of the greater 

computing power of that laptop, for example, 

compared to anything we had at the time. They do 

more flexible modeling and use a more sophisticated 

treatment of uncertainty. 

 Now we took this job on with the 

understanding that it was an interim update, it 

would bridge the gap between BEIR III and BEIR VII 

-- which hasn't happened yet, they haven't had their 

report -- carried out by a small working group, 

based mainly on A-bomb survivor data which we could 

get easily, and especially original incidence data 

from the RERF Tumor Registry. 

 And emphasis was placed on uncertainty 

because it seemed that uncertainty -- the upper 

limits was in fact the way things were going to be 

done. And so we fitted statistical uncertainty 

based on likelihood contours of fitted risk 

estimates. That's a statistician sort of thing. 

And our treatment of other sources of uncertainty 
follows the two NCRP reports, the Commentary 14, 

which was written by Owen Hoffman, and Report 126, 

which was led by Orin Sinclair. 

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 We had -- the 1985 group had an NAS 

oversight committee, and a rather high-powered one, 

and they emphasized a number of points, one of which 

was that PC values pertain to populations, not 

individuals. They're not probabilities in the usual 

sense. They're really properties of the group to 

which a person belongs, but they are -- it's a 

societal convention. We agree to do this. We 

assign to the person, for purposes of compensation, 

the probability of causation or the assigned share 

or the attributable risk that belongs to a group in 

which this person belongs. We have no idea what an 

individual's probability of getting cancer is. 

Really, it's -- we just have this thing on groups. 

And insurance companies work the same way. 

 The oversight committee recommended 

replacing probability of causation by assigned share 

and -- to emphasize the difference, and we've done 

that, and I don't suppose it's going to stick. 

 The 1985 committee thought about it and 

decided not to do it because everybody was using PC, 

but we decided to do it, but it probably won't make 

any difference, either. 

 The neat thing about this is that the 
82 assigned share value and its uncertainty -- and its 

uncertainty, and I emphasize uncertainty -- 

summarize what we know and what we think we know 

about excess risk or especially excess relative risk 

of cancer following radiation exposure. It's our 

best estimate and it's also our estimates that we 

think are allowable or reasonable. And these 

scientific findings also may be relevant to the 

adjudication of an individual claim. And we don't 

make any claims regarding the influence of factors 

that we haven't studied. 

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 There are a lot -- obviously there are a lot 

of things to determine whether a person gets cancer, 

and there are probably a lot of things that we don't 

know about that determine why a person gets cancer 

after radiation exposure. If we don't know about 

it, well, we can't do anything about it. 

 I mention that there is a critical view 

especially enunciated by Sandra Greenland that it's 

a logically flawed concept. It's subject to bias 

and it's unsuitable as a guide to adjudication of 

compensation claims in cases of possibly radiationinduced cancer. 

 And I -- my answer to this is that, you 

know, he's probably right, if he's thinking about an 

individual's probability. But we don't know -- we 

know that we can't do that. And his particular 
8 example, argument by counter-example, doesn't seem 

very persuasive, but things may change. And just 

generally, population characteristics are often used 

as a guide in individual decisions, so this isn't 

anything new. We're just doing what we always do. 

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 Some differences with the 1985 report. 

Well, I've mentioned that we're using incidence 

rather than mortality. We have more sites because 

we have more data and can do more things with it. 

It includes -- the previous report mostly was based 

on sites for which there was a proven association of 

cancer risk with radiation dose. And what that 

means is that the lower uncertainty limit, the 

statistical uncertainty limit, was greater than 

zero. Okay? That's -- if you're -- if you are 

interested in proving that a particular cancer or in 

-- generally a cancer is related to radiation, 

that's a good criterion to follow. But if you're 

adjudicating a claim, I think it's different because 

it seems that -- I think that if you followed that 

rule you probably wouldn't ever compensate anybody 

at all because you'd be dealing with absolute, 

ironclad proof. We know that this is related to 

radiation. The question is, is the possibility 

enough to be worth -- so that it's reasonable to 

award a claim. 

 We based our treatment -- this is of radon-
associated lung cancer was based on the 1995 RECA 

report for the Department of Justice. We used a 

computer program instead of tables. I think that's 

a big advance. And more -- again, more emphasis on 

uncertainty; little on point estimates. It relies 

on Monte Carlo simulation for calculation of most of 

the uncertainty distributions. That's not 

necessarily a better thing to do, but it's certainly 

a lot easier and that's why we did it; we can do it. 

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 84

 I'm going to give you a graphical synopsis 

of our approach, stating with the statistical 

uncertainty distribution, which is for the A-bomb 

survivors and it's in fact what we would use as the 

basis of the assigned share calculation for members 

of that population, if A-bomb survivors were making 

claims. That's what we would use because it's based 

them. So this example is a sex-averaged excess 

relative risk per Sievert for all solid cancers, and 

it looks sort of like that. That's the probability 

density of the uncertainty distribution and things 

that are in the middle are pretty likely and -- or 

we think are pretty likely, and the ones off on the 

tails we think are very unlikely. 

 And that's the cumulative form of the same 

distribution and I'm just -- I have this here just 

to demonstrate that if you want to get an upper 

confidence limit, what you do is go up here to where 
the 90 percent or 95 percent, you go over to the 

curve, then you drop down and that's your limit. 

I'm going to show you a lot of these things. 

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 These are statistical uncertainty curves for 

leukemia, excluding chronic lymphocytic, by age at 

exposure and time after exposure. The green lines 

correspond to exposure age 20, for different times 

after exposure, and the purple lines correspond to 

exposure age 30, again by time after exposure. And 

you see that as the age at exposure gets older, the 

risk -- the distribution moves to the left, there's 

less risk, and also as the time after exposure, it 

lengthens, the curves move to the left. 

 Here again -- this is a different scale. 

You see that it's just the same thing carried on at 

larger numbers of years after exposure. 

 This is thyroid cancer by age at exposure. 

It doesn't really depend on -- as far as we can 

tell, depend on time after exposure. And thyroid 

cancer is the one cancer that has really the 

greatest dependency of excess risk on age at 

exposure. Thyroid cancer is much more likely to be 

caused by or to occur after a radiation exposure at 

a young age than it is at older ages. And in fact, 

there's some doubt whether among adults there's 

really any risk at all. 

 Now the next thing. That was the 
statistical uncertainty. Now transferring to the 

U.S. population, we have several problems. One is 

the dosimetry. For the A-bomb survivors, has errors 

and biases and -- but it works just fine when we're 

doing things for the A-bomb survivors. But when -- 

but that doesn't pertain to the U.S. population, 

which has different dosimetry, so we are assuming 

that the U.S. population has an exact distribution 

-- and exact dosimetry, or one at least that is 

known in terms of uncertainty. And there is some 

adjustment that has to be done. 

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 86

 There's also the fact that baseline cancer 

rates, particularly site-specific baselines, differ 

between Japan and the U.S., and we don't know what 

effect that has on radiation-related risk. The 

differences are only a few percent for all solid 

cancers combined, but for stomach, liver, prostate 

gland -- and actually breast is close -- it's an 

order of magnitude, and it really makes a 

difference. 

 So first -- this is sort of out of line, but 

anyway, let me just say it. Okay, we don't know 

exactly how to adjust for either of these two 

factors, but they can't be ignored. There's 

information. It's not as well quantified as the 

statistical uncertainty shown in figure 1, and so we 

use expert judgment. So this is -- what you are 
seeing is not what we get from the data, but also 

what we think we know after we thought about it a 

while. And the important thing is that we say how 

we got there. And if you want to do it differently, 

you can, you just have to specify how you got it. 

It's more or less the rules. 

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 Okay. So again here's the statistical 

uncertainty distribution -- oh, sorry, that wasn't 

right. That was the statistical uncertainty 

distribution for dosimetry. It's just -- okay, 

that's sort of a throw-away. 

 This is the comparison of U.S. and Japanese 

breast cancer rates, and the thing here is they're 

very different. And let's say here's baseline based 

on A-bomb survivor data. And let's say this is the 

risk for some people who have -- estimated risk for 

people who have had a certain dose. And then we can 

take the difference and we can transfer it, or we 

can take the ratio and we can transfer that. And it 

really makes a lot of difference, so we have to 

handle that somehow, and the way we do it is by 

fuzzing, putting an uncertainty -- actually, the 

additive transfer is better because we do have 

information on breast cancer. But if we're just 

ignorant about it and we -- and on this graph, zero 

represents multiplicative and one represents 

additive, that's an ignorant uncertainty 
distribution. Well, it's somewhere in there; we 

don't know. And maybe it might be in fact maybe 

sub-multiplicative or super-multiplicative at/or 

super-additive, and so we have a little bit of 

probability out just beyond these things, but one 

represents additive, zero represents multiplicative 

and things in the middle represent linear 

combinations of the two. 

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 This is what we did for breast cancer. We 

had quite a bit of evidence that the breast cancer 

situation -- it corresponds more to an additive 

transfer, so we put -- I think that what we really 

put it is we put half of the probability on one and 

we have put half the probability on the ignorant 

distribution. So this is a subjective uncertainty 

distribution for the combined dosimetry and 

population factors. So there's -- it sort of leans 

a bit to the left, but there's this tail that goes 

out here that allows for risk to be considerably 

greater. 

 And what have we got? I hate this when this 

happens. Okay. 

 (Pause) 

 So we, in a sense -- in essence, this is the 

distribution of a factor that we use to multiply our 

uncertain risk estimate by, so -- there we are. And 

the red dash thing -- I'm really surprised at that 
8 -- is the original one, and -- oh, this is wrong. 

It's wrong. I corrected it on another one, but it's 

wrong. This distribution -- really the distribution 

should look more like this. 

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 UNIDENTIFIED: Speak up, please. 

 DR. LAND: Pardon? The redistribution 

should look more like this. That's an error, and 

I'll show a graph later that you'll see it 

corrected. 

 Okay. The most -- this is a statistical and 

epidemiological fact. The most informative 

epidemiological data on radiation risk -- related 

risk pertained to acute, high-dose exposures. And 

it's a signal to the problem. You have -- when the 

dose is high, you have a nice high excess, you don't 

have to worry so much about the variation in the 

baseline. If you have a very low dose, you do have 

to worry about that and it's the information -- it's 

-- you don't really get very informative data. So 

you have to extrapolate estimates from high doses to 

low doses. 

 And a lot of work has been done on this 

using -- which suggests that the risk per Sievert is 

less at low doses and low dose rates than for acute 

high-dose exposures, and so there is a dose-anddose-rate-effectiveness factor which is sometimes 

applied. The ICRP recommends using a DDREF of two 
for doses less than two and for chronic -- sorry, 

doses less than .2 Sieverts and for chronic doses. 

We didn't -- we thought that was kind of abrupt. 

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 This is the -- what the NCRP Report 126 

used, a subjective uncertainty DDRF factor for lowdose extrapolation of risk, and this is what we 

used. It's discreet. Doesn't make much difference, 

really, and it has more weight on one and it has a 

little weight on the possibility that actually the 

risk might even be a little greater at low doses. 

Not much, but some. Actually it's -- it probably is 

pretty influential. 

 This actually is more in keeping with the 

mainstream thought now, I think. At least that's 

what I get from the ICRP. 

 You know, I think I'll just forget -- this 

is the DDREF we -- which is -- what it means to have 

a DDREF of one, what it means to have a DDREF of one 

and a half, that's in red; what it means to have a 

DDREF of two, that's in green, and so forth. And 

this is the distribution of the threshold of the way 

the DDREF is assumed to come in. Remember, you're 

dividing by this value. And for a threshold dose, 

and the previous graph showed -- or assumed a 

distribution for the threshold dose, dose which is 

log-uniform. Again, it's something that is open to 

discussion. People can change it, but that's what 
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 91 we used. 

 Now here the red is -- again, is our 

original statistical uncertainty distribution. The 

green is what we get when we apply the transfer 

between populations, the error in the dosimetry and 

the DDREF. The DDREF is an extremely powerful 

thing. It really changes -- it really changes 

things. 

 And this is in terms of the upper confidence 

limits. You see the -- you probably can't see the 

number in green, but anyway, it changes the 95 

percent upper confidence limit from .76 to .56 for 

the excess relative risk per Sievert. 

 And this is just a -- the figure on -- up in 

the upper corner is the original statistical 

uncertainty. The figure in the right -- upper right 

is the one that was messed up before and it's -- you 

see it moves a little bit over to the left and it 

spreads out more. And then the one here in the 

lower left is the one I just showed you, after 

you've applied the DDREF, and then the cumulative 

form. That's essentially it. That's how we do it. 

 And this is taking the same thing and 

shifting from the excess relative risk, which can go 

up to anything, I guess, to an assigned share, which 

is constrained to be between zero and one. And so 

in this case, the assigned share for a low-dose 
exposure, .1 for all solid cancers combined, is 

about -- is a little over five percent. The upper 

limit, 95 percent. 

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 I'm almost done, actually, and this is a -- 

just a list of our -- a group of advisors who met 

with us from the very beginning -- Pat Buffler; 

Lars-Erik Holm, Swedish Radiation Protection 

Institute; Jerry Puskin, EPA; Dan Schafer, 

Department of Statistics, Oregon State; Lincoln 

Grahlfs, Atomic Veterans Association; Seth Tuler, 

Social and Environmental Research Institute. 

 We also had -- were reviewed in -- in 2000 

we actually went to the review on -- presented in 

May and then we got their report at the end of 

November in year 2000, and they -- a very thoughtful 

review. They suggested a lot of things that we 

might think they could do and things they really 

wanted us to do, and one of the things they really 

wanted us to do was to -- not to have sites that 

have -- that are based on very few cases. They said 

they recommended grouping -- grouping the sites 

where you have fewer than 50 -- actually I don't 

think they said 50, but that's what we did -- 

exposed cases. That is, cases among those who had 

-- were radiated. 

 And a shared-site modeling for estimation of 

modifying influences of age at exposure and at 
diagnosis. That's easy to say, but it's kind of 

involved and it took us a while to do it. 

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 And finally, inclusion of estimates for 

radon-related lung cancer and non-melanoma skin 

cancer, neither of which we wanted to do. The lung 

cancer because the BEIR VII -- I'm sorry, the BEIR 

VI and BEIR IV models for radon-related lung cancer 

are really kind of hard to translate into 

probability of causation or assigned share because 

the risk curves go like this (indicating). And you 

can imagine somebody saying who is here instead of 

here. You know, it wouldn't be a happy thing. But 

we found that there was a dataset and a report, this 

RECA report, and we based our -- we actually did an 

analysis of the original data for the RECA report. 

And they also recommended -- well, non-melanoma skin 

cancer, we didn't want to do that because the nonmelanoma skin cancer rates in the United States -- 

it's not a reportable cancer and it's kind of hard 

to get -- to get rates, but we -- finally we talked 

ourselves into it and there is this -- there was 

this study of the A-bomb survivors which we could 

use in calculating because in Japan non-melanoma 

skin cancer is reportable because they don't have 

very much of it. 

 And finally NIOSH -- NIOSH was concerned 

about the motivation for our NCI changes in default 
94 modification -- default -- what am I -- what is that 

they say? Oh, our treatment of exposure age and 

attained age, and it's -- this model is -- this is 

the standard model. 

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 That is the standard that's been used in 

most recent analyses of A-bomb survivors, 

particularly the Tumor Registry, and it means that 

there's -- the modification of excess relative risk 

is a smooth function of age at exposure and a smooth 

function of attained age. But you get right down to 

it, it's really driven by things in the middle. And 

you really don't know, particularly for very older 

ages, there isn't really a whole lot of information 

that suggests that the excess relative risk keeps 

going on, going down, and so we used a modified one 

which said we were -- instead of having this kind of 

a function, something that goes like that, we picked 

one that went like that. So that at the extreme 

ages we had something that was more like the rest. 

And it turns out that in fact the -- that function 

fits the data every bit as well as the other one. 

And since it's friendlier to the claimant, we 

decided to use it. 

 This is a completely NIOSH initiative. We 

were -- had planned just to use the ICRP RBE's, but 

they commissioned with SENES for a comprehensive 

report -- treatment on uncertain RBE's for photons 
with different energies, electrons, neutrons and 

alpha particle radiation other than radon. And it's 

-- I understand it's still under peer review, but it 

-- I've talked to people that know a lot about this, 

in particular, Keith Eckerman, and he thinks it's 

all right, and that's good enough for me. 

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 And then this creation of a separate NIOSH 

version of IREP which incorporates NIOSH's 

administrative rules for application of our report 

to claim adjudication. It's sort of like -- it's 

sort of like a combination, I understand, of CIRRPC 

and the original one, and I think that's -- I think 

that's just fine. 

 I always say we have this kind of light that 

we really care about the scientific questions of 

getting the best scientific information that we can, 

given our poor abilities and so forth, but we really 

do want to stay away from the administrative 

decisions about how you actually award things. So 

we think that what we give you, this uncertainty 

distribution, is the best we can do as far as a 

summation of the scientific evidence relating to a 

particular claim. And then what you do about it is 

really up to you. It's about to the administrating 

agencies, it's up to NIOSH, it's up to the 

Department of Labor, it's up to the VA. And it 

seems that's it. 
 DR. ZIEMER: Thank you, Dr. Land. We 

probably have a number of questions, so let's open 

the floor for questions at this time. Perhaps I'll 

start the questions. You raised an issue concerning 

radon and the use of radon in this model. In 

general, radon is part of everyone's background 

exposure of course, but in some facilities radon is 

part of the occupational exposure. It wasn't clear 

to me how radon is handled in your models here. 

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 DR. LAND: We use -- 

 DR. ZIEMER: Of course they're not using 

dose data, to start with. They're using -- 

 DR. LAND: No, it's exposure data and 

working level months, and we -- we really tried very 

hard -- the dataset we had was slightly different 

from the one used at RECA. It didn't have some of 

the really high doses in it, but we -- first thing, 

we tried to duplicate certain tables in the RECA 

report, and we managed to do that. And then we then 

went to the logical way of modeling the excess 

relative risk as a function of age at last exposure 

and time since last exposure. And it's a -- I can't 

exactly remember the model, but it's -- actually 

it's working level months -- it's something like the 

.83 power, so it's kind of -- it has the sort of 

downward curvature. And the dependence on age at 

last exposure and time since last exposure is 
97 similar to what we did with age at exposure and age 

at diagnosis for the other cancers. That is flat -- 

down flat. 

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 DR. ZIEMER: But you still used the exposure 

information -- you don't convert it to dose in any 

way -- 

 DR. LAND: No. 

 DR. ZIEMER: -- first. Yeah. 

 DR. LAND: No, it's -- the whole thing is -- 

the whole thing was -- the data are in terms of 

working level months. 

 DR. ZIEMER: Right. 

 DR. LAND: Yeah. So -- yeah. I don't want 

to get into that. 

 DR. ZIEMER: No. 

 DR. LAND: That would be really difficult. 

 DR. ZIEMER: Okay. Gen Roessler? 

 DR. ROESSLER: With regard to your grouping 

of sites with less than 50 exposed cases, I kind of 

have this picture of a lot of people sitting in a 

room and a lot of cases on the table and you're 

trying to think how to put them together. What is 

your rationale for grouping? Is it biological or 

physiological or anatomical or -- I mean I can't 

quite envision that. 

 DR. LAND: For example -- an example would 

be -- let's see, this is cancer -- no, not cancer of 
the pharynx. Okay, well, just say -- take an 

example, miscellaneous digestive cancers. There I 

think what else can you -- are you going to use? 

Because we can't really do an estimate -- a separate 

estimate for miscellaneous digestive cancers. The 

data wouldn't support much. So we just say well, 

it's -- let's -- this is a suggestion, by the way. 

I would not be so bold as to say well, you should 

use this. It's suggested you use it. It suggests 

that it's a reasonable thing to do. But if you want 

to do something else, that's your decision. But 

we're trying to -- we're doing the sort of the 

groupings that we thought were most logical, as a 

convenience, really. Let me think of a -- oh, we 

did bladder and -- let's see. I'm sorry, I'm trying 

to think of examples, and I'm sort of blanking. I 

know we treated urinary, bladder and kidney and 

other urinary disease -- we thought that for bladder 

cancer you could justify a site-specific estimate. 

But for kidney and other cancers of the urinary 

system, we'd use the grouped, because you couldn't 

get over 50 cases. I don't feel that I'm really 

answering your question really well, but can you 

sort of see the drift of it? 

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 DR. ROESSLER: I can kind of see the drift, 

and I think overwhelmingly I support the idea. I 

think to come up with a rationale for grouping makes 
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 99 really a lot of sense. 

 DR. LAND: Yeah. 

 DR. ROESSLER: But I just wanted -- and I 

think you've kind of explained how you looked at it. 

 DR. LAND: We sort of did the best we could, 

I guess is what you'd have to say. We didn't try to 

take things that are way far afield, except there is 

a general residual category. 

 MR. GRIFFON: Just a question on the DDREF 

value. We heard from some other people who might 

have either -- either in written testimony or spoke 

before the Board that the recent RERF lifespan study 

group recommended actually a value of unity on 

DDREF. I'm not sure if I'm getting this right, so I 

just wondered if you considered their input into 

your analysis for distribution or... 

 DR. LAND: I'm sorry, I didn't understand 

the bit about RERF. 

 MR. GRIFFON: The lifespan study group. 

 DR. LAND: Yes, right. 

 MR. GRIFFON: Apparently they recommended a 

DDREF value of unity rather than previously-reported 

value of two, and I wondered if -- 

 DR. LAND: RERF wouldn't do that. 

 MR. GRIFFON: Huh? 

 DR. LAND: I can't -- lifespan study? They 

don't work with X-rays and things -- or sorry, a 
10 DDREF of -- oh, excuse me, I'm sorry. I get RBE's 

and DDREF's mixed up in my head sometimes. Yes, 

they do. That's because -- okay, that -- you 

actually touched on something that's really kind of 

hot. 

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 Epidemiological data look linear. You would 

use a DDREF of one, yeah. The epidemiologists all 

say use a DDREF of one because -- and -- but it's 

based on linearity of the dose response. Okay? You 

have -- you're fitting -- you have all these doses 

and you're fitting -- and it's mostly depending on 

the high-dose stuff, and you get a line that just 

goes down and then hits some value at zero dose. 

And there's very little evidence to suggest not 

using a line. All right? If you take that as your 

default. But there's all this experimental evidence 

which -- and some of it is kind of strong, but it's 

not based on -- it's not really mostly cancer, it's 

analogous systems. It's chromosome elaborations and 

mutations and tridyscantia and that kind of thing, 

and you get this very clear curvilinear form -- 

function. And -- well, the ICRP says use two. The 

NCRP says use something like that, so how far do you 

go against the official consensus, you might say. 

Well, what we did is we fuzzed it and we have -- 

actually we have quite a lot of probability on one. 

 We have some probability on less than one. And 
101 actually as it comes -- moving a little probability 

on one makes a big difference in the upper 99th 

percentile of your uncertainty distribution. So you 

know, it's -- but we're not supposed to be sitting 

there with your thumb on the scale. But this -- it 

seemed reasonable. 

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 DR. ZIEMER: Mark, does that answer the 

question? Yeah. 

 MR. GRIFFON: I had other questions, but 

I'll (inaudible). 

 DR. ZIEMER: Roy? 

 DR. DEHART: Physicians are not supposed to 

be very good on statistics, and I certainly fit that 

model, but I do know a little statistics. But would 

you mind going through figure seven and walking us 

through that specifically, that figure -- if they 

could bring it back up for you? 

 Particularly I'm interested in the ERR per 

Sievert that we're -- you're dealing with here and 

trying to understand what would happen if you had 

more than one dose exposure. Number seven -- it's 

this one. 

 DR. ZIEMER: There's some other figures -- 

 DR. LAND: That's it. Okay. First place, 

it's the cumulative form of the probably more 

familiar density distribution that just preceded it. 

 DR. DEHART: Yes. 
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 DR. LAND: 102 And now the question again? 

 DR. DEHART: Would you just simply walk us 

through this -- this presentation, this graph. 

 DR. LAND: This particular graph -- 

 DR. DEHART: Yes. 

 DR. LAND: -- well, it's how you get an 

upper confidence limit. It's just you take the 

uncertainty distribution, you use -- you put it in 

its cumulative form and then you want a -- if you 

want a 99 percent confidence limit, you move your 

figure -- oh, sorry. This is the uncertainty 

distribution for assigned share. And -- no, excuse 

me, I'm wrong. I'm confused again. This is for the 

low-dose excess relative risk, yes. 

 If I'm going to go very deep into it, I have 

to go back and use -- look at other graphs, but just 

given the uncertainty distribution, that density 

distribution, take the cumulative form of that 

density distribution, however you got it, and to get 

an upper confidence limit -- what's graphed here is 

the 95 percent upper confidence limit. 

 MR. GRIFFON: Actually, if I can offer -- 

your next slide I think on four steps that you went 

through to get to this one. 

 DR. LAND: Oh, yeah, that's true. Yeah, 

that's actually -- right. This is how we get there. 

 Is that what you want? 
 DR. DEHART: 103 I was just trying to -- how to 

get there and looking at figure seven. I'll do some 

studying and meet with some other people and try to 

understand it -- 

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 DR. LAND: Well, how you use it -- you go 

over to wherever you want it to go over here, you go 

down and that's your limit. But basically that's 

the statistical uncertainty distribution, and to its 

right is the statistical uncertainty distribution 

after you have multiplied the excess relative risk 

by an uncertain factor that adjusts for error in -- 

error bias in the A-bomb survivor dosimetry and for 

the problem of moving from one population to 

another. Okay? You multiply those two factors 

together and their distributions, they're the 

convolution of those two distributions, is the thing 

in green. Okay? And then we do the same thing 

again and we applied the DDREF. We apply -- the 

DDREF has this other distribution and so we multiply 

-- I'm sorry, we divide by the DDREF and the 

convolution of the distributions there, the 

uncertainty distributions is this and the cumulative 

part of this is that. 

 DR. ZIEMER: Okay. Mark, you have an 

additional question, apparently. 

 MR. GRIFFON: Going back to the Monte Carlo, 

and this is a -- since I'm a novice in Monte Carlo 
104 calculations, one of your overheads said that Monte 

Carlo simulation for calculation of most uncertainty 

distributions, not necessarily better, but certainly 

easier. 

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 DR. LAND: Yeah. 

 MR. GRIFFON: And I just wondered if you 

could expand upon that for those of us who don't 

understand Monte Carlo that well. 

 DR. LAND: Okay. Let me just say what 

analytically this would involve. If you had these 

various uncertainty distributions, you would have -- 

you'd have to -- if you -- if they were all 

lognormal distribution and you were multiplying and 

dividing them, it'd be real easy. If you have -- 

the kind of distributions we have, it would be 

really, really difficult to do. 

 But the Monte Carlo procedure just says 

well, all right, we have this factor and it has a 

certain distribution, and this factor and it has a 

certain distribution, and actually you do something 

like 1,000 replications of multiplying one factor 

and another, sampling from the -- where one 

distribution for the first factor and from the other 

distribution for the second factor, multiplying them 

-- those two together and you get a point. And you 

do that 1,000 times and you get a distribution, and 

that's what we use. That's the way it's done. 
 105 It's -- back in the days when we were doing 

the 1985 report, we wouldn't have done that because 

it would have taken a very long time. But now -- in 

fact, everything in the 1985 report was based on 

lognormal probabilities. But with -- now with 

computers so fast, it's really easier to do it this 

way. 

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 If I could just take this and use it as a 

little bit of a soapbox, the problem is using the 

upper 99th percentile because it is -- unless you 

have a really large sample size, the 99th percentile 

is -- estimate is unstable. But if you have a 

really large sample size, it takes a long time to do 

the simulation and that's a real problem, a real, 

real problem. And I don't know how you're going to 

solve that. Maybe a super-computer or -- actually 

maybe not have it over the web -- not have people 

doing things over the web 'cause they'll sit there 

for ten minutes and they'll get very upset. 

 DR. ZIEMER: Tony? 

 DR. ANDRADE: By the same token, if you 

sample many, many times rather than just 1,000 -- 

say you go to 10,000 -- 

 DR. LAND: Yeah. 

 DR. ANDRADE: -- doesn't the confidence -- 

 DR. LAND: The estimate is much better for 

10,000 than it is for 1,000. 
 DR. ANDRADE: Exactly. Doesn't it 

stabilize? 

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 DR. LAND: It -- yeah, it's probably 

acceptably stable. But it's going to take you ten 

minutes. 

 DR. ANDRADE: Yeah, but today, using the 

computers that we have, that's nothing. And so -- 

 DR. LAND: Oh, if you have a better 

computer, yeah. But real money rides on this. 

Right? 

 DR. ZIEMER: That's why they call it Monte 

Carlo. 

 Further questions? Okay, thank you very 

much, Dr. Land. We appreciate your being with us 

today here. 

 We're going to break for lunch in just a 

moment. I want to ask if there are any housekeeping 

announcements before lunch that we need to make. 

Staff people? 

 I will make one now, but will remind you of 

it later, and that is that at the end of the day 

today we need to clear everything out of the room 

because there will be a reception of some sort here 

-- not for our group, but a wedding reception or 

something later this evening, so you cannot leave 

things overnight expecting them to be here in the 

morning. So I tell you that, both Board members and 
107 visitors, we do have to clear the room at the end of 

today's session. 

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 UNIDENTIFIED: Can we get an invite? 

 DR. ZIEMER: Yeah, if you do a good job of 

cleaning up, why we'll give you a reward. 

 Now this afternoon we will have the 

presentation on NIOSH-IREP, and I think if Mary 

Schubauer-Berigan does not arrive, I think -- oh, 

she has arrived? Okay, great. I was going to say, 

Russ may have to give that, but we're glad that she 

now has arrived. 

 UNIDENTIFIED: I wanted Ted to give that. 

 DR. ZIEMER: We also have some other changes 

in the afternoon agenda that are different from -- 

or we have some changes from what you have in your 

booklet, and we'll tell you what those are when you 

return from lunch. 

 Our experience has been that it does 

generally take a good hour and a quarter to make 

sure everyone gets their lunch and can get back, so 

it's not quite quarter of, but we're going to recess 

at this point and we'll reconvene at 1:00 o'clock. 

Thank you very much. 

 (Whereupon, a luncheon recess was taken from 

11:35 a.m. to 1:00 p.m.) 

 DR. ZIEMER: We're going to now reconvene 

and proceed with the next item on the agenda, which 
is the presentation by Dr. Schubauer-Berigan, 

finalized NIOSH-IREP. So we'll proceed with that 

presentation, then have a chance for questions and 

discussion following. 

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 108

 DR. SCHUBAUER-BERIGAN: Good afternoon. I'm 

very glad to be here with you. It seemed that the 

weather was conspiring against my arrival in 

Washington this morning, but I'm glad to finally be 

with you and speak to you today about the software 

program, NIOSH-IREP, in its final form. 

 Today I will be discussing rather briefly 

the modifications that were made to NIOSH-IREP based 

both on the public comment and on scientific expert 

review. 

 I unfortunately missed most of Dr. Land's 

presentation this morning, but I did want to 

recapitulate some of the most important concepts in 

the probability of causation rule for you, just to 

make sure that we're all starting from the same 

page. 

 First is that EEOICPA requires the 

calculation and use of the probability of causation, 

which we abbreviate as PC. EEOICPA also mandates 

the use of the standard that the cancer was at least 

as likely as not to have been caused by the 

claimant's radiation exposure at the upper 99th 

percentile of its uncertainty distribution. This 
10 requirement reduces the chances that a claim which 

meets this standard of being as likely as not caused 

by radiation would be denied, given the substantial 

uncertainties in the scientific information that's 

used to derive the probability of causation. 

Probability of causation is approximated by the 

calculation of assigned share. This is also known 

in epidemiology as the attributable fraction. It's 

important to note this because the NCI-IREP program 

is defined in terms of the term assigned share. 

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 Some of the other important points about 

NIOSH-IREP include the fact that it allows for the 

incorporation of uncertainty in several factors -- 

dose, the dose-response relationship, as well as 

other factors that I'll discuss. 

 The upper 99th percentile PC will be 

calculated by the Department of Labor, using NIOSHIREP software. 

 As you heard this morning, the basis of 

NIOSH-IREP is the NCI-IREP, which we have 

specifically adapted for use in EEOICPA. 

 NIOSH was required to develop methodology 

for all cancers that are deemed radiogenic. 

Therefore we have developed a program that allows 

DOL to do this. 

 And you -- again, this is probably a repeat 

for those of you who were here this morning, but 
probability of causation is calculated as the 

relative risk minus one divided by the relative 

risk, or an equivalent expression is the excess 

relative risk divided by one plus the excess 

relative risk. Relative risk is estimated from 

epidemiologic models of dose and cancer risk. And 

separate models were produced for each cancer or 

group of similar cancers. 

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 110

 How is the probability of causation 

estimated? The models that are used incorporate 

uncertainty. This is a central tenet of the 

development and use of these models. They 

incorporate uncertainty from five major sources. 

First is the statistical uncertainty that exists 

about the relative risk estimates. Second is 

uncertainty associated with the exposure of the 

study population from the epidemiologic analysis. 

Third is uncertainty about the effects of 

confounding variables. Fourth is uncertainty in the 

method by which the risk should be transferred from 

the epidemiologic study to the population of 

interest. Lastly, there is uncertainty that is 

associated with the exposure of the claimant to 

radiation. 

 Now I'd like to talk about modifications 

that were made based on the comment period. First 

is that some of the risk coefficients were revised 
11 for certain cancer models in NIOSH-IREP. Based on 

the comments of several of the reviewers; to wit, 

that squamous cell carcinoma does not tend to 

exhibit as strong a dose-response relationship as 

basal cell carcinoma, we have reverted to new models 

that were developed by NCI-IREP only very recently. 

 These are separated into a model for basal cell 

carcinoma and one for squamous cell carcinoma, and 

upon review of the NCI's models and with the 

recommendations of our scientific experts, it seemed 

justified to develop -- to use two different models 

for these two cancer types. However, if the 

claimant's skin cancer -- non-melanoma skin cancer 

cell type cannot be determined by Department of 

Labor, they must use the basal cell carcinoma risk 

estimates, which are generally -- are always higher 

than the squamous cell. 

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 A second alteration is for bone cancer. The 

original NIOSH-IREP used a set of risk coefficients 

that were published in an appendix of a study of the 

Japanese atomic bomb survivors, and on discussion 

with our scientific experts and with NCI, we 

determined that those models were really -- didn't 

lend themselves well to risk analysis because they 

were based on such small amounts of data. Instead 

we used the residual cancer risk coefficients that 

were developed by NCI, and those do include risks 
from bone cancer cases, as well as other cancer 

sites. 

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 Secondly we made modifications of the risk 

transfer functions for some cancers. For skin 

cancer we use a general uncertainty distribution 

which equally weights the multiplicative and 

additive interaction model. The previous version of 

NIOSH-IREP favored an additive model. However, on 

review -- further review of the literature and with 

recommendation of several subject matter experts, we 

determined that the general uncertainty distribution 

was more appropriate in this case. 

 Similarly, for male breast cancer we used 

the general uncertainty distribution rather than the 

distribution that favors an additive interaction. 

 We incorporated an inverse dose-rate 

uncertainty distribution for alpha radiation 

exposures. This brings the treatment of alpha 

exposures in line with other high LET radiation, 

mainly neutron exposure. There was initially the 

incorporation of an inverse dose-rate effect for 

neutrons, and we've simply added that distribution 

for alphas on the recommendation of subject matter 

experts and our own opinion. 

 I'll be talking about some of these 

modifications in the next couple of slides, but I 

wanted to show -- mention that we did modify the 
113 dose and dose-rate effectiveness factor or DDREF to 

more heavily weight a value of one, on the basis of 

expert opinion. 

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 We also modified some of the uncertainty 

distributions for the RBE factors, for low-energy 

photons and X-rays, for neutrons and for alpha 

particles, and I will discuss these in a minute or 

two. 

 To show you how we changed the DDREF, I made 

up this slide and I think this repeats some of what 

Charles Land told you this morning, but I wanted to 

illustrate the version that we used in the draft 

NIOSH-IREP with the final version. 

 The arrow here points to a sort of 

continuous-looking distribution, which was the draft 

distribution used, and that had a mode or a high 

value at two, a DDREF of two. We shifted the 

distribution, and this follows NCI's recommendation 

as well, to more heavily weight a value of one, and 

so you can see that it's no longer a continuous 

distribution. It's actually discreet and it is 

slightly shifted towards one. This is the 

distribution used for all solid cancers except 

breast and thyroid, which are showed here. 

 And this is a slightly different 

presentation. In both cases the distribution was 

discreet, and the final version is shown in the 
11 back, just simply because it displayed better that 

way. What happened here is that the draft 

distribution had no values in the uncertainty 

distribution below one, and we felt that it was more 

consistent with the approach used for other solid 

cancers to include a probability -- a small 

probability that the DDREF is actually less than 

one, and so we've shifted some of the weight to that 

direction. 

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 Those really are the changes that we've -- 

well, here let me talk about the RBE distributions. 

 These are now given a different term. This was 

actually the subject of a lot of discussion between 

the subject matter experts, what should these things 

be called, and the decision was to revert to the use 

of the term radiation weighting factors. However, 

these will be defined differently than they're 

typically understood by the health physics 

community. 

 For photons there was a slight redefinition 

of the class that's considered high energy photons. 

 That was changed from a lower bound of 200 keV and 

it was raised to 250 keV. 

 MR. ELLIOTT: Mary, could I interrupt you a 

moment? 

 DR. SCHUBAUER-BERIGAN: Yes. 

 MR. ELLIOTT: I'm sorry, but I know folks 
1 are looking for this slide and I don't think it's 

included in the booklets that we gave you. It's a 

last-minute -- 

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 DR. SCHUBAUER-BERIGAN: That's right. 

 MR. ELLIOTT: -- introduction of that 

information. 

 DR. SCHUBAUER-BERIGAN: This will be alluded 

to towards the end, but I may as well mention it 

now. We had extensive review of the documentation 

of the RBE distributions, and we've only received 

some of the final subject matter expert comments 

within the last week, and so these revisions are 

literally hot off the press. Within the past 

several days these have become final and have 

delayed the production of the final NIOSH-IREP by 

about a week. So this is -- we were unable to 

produce this slide in time for you to have it in 

your packet, but it will be made available to you as 

soon as possible. 

 So for photons, there was also a small 

increase in the uncertainty distribution which 

raises the upper tail, making the distribution 

spread out in the upper regions more. This was on 

the basis of new data that was included in the 

analysis for the purposes of developing these RBE's. 

 For neutrons, the same change was made. 

There is a slight increase in both the central 
tendency and in the uncertainty distribution for 

neutrons. And for alpha particles there was also a 

slight increase in that RBE uncertainty 

distribution. 

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 DR. ZIEMER: Can I interrupt, just a quick 

question? 

 DR. SCHUBAUER-BERIGAN: Sure. 

 DR. ZIEMER: Are all of these distributions 

now discreet points rather than continuous, or just 

the one? 

 DR. SCHUBAUER-BERIGAN: No, they're -- the 

DDREF is -- there's -- that's been completely 

discreetized -- 

 DR. ZIEMER: Right. 

 DR. SCHUBAUER-BERIGAN: -- so both of the 

final ones are. In the case of the RBE 

distributions there's a mixture of continuous and 

discreet distributions, and there's a table that 

will be produced with the final documentation that 

will clearly show what those distributions look 

like. I don't have it with me at the moment. 

 DR. ZIEMER: Has someone shown then that if 

you do a Monte Carlo with a discreet versus a 

continuous -- if you do enough samples you get about 

the same result? 

 DR. SCHUBAUER-BERIGAN: I don't know that 

that testing has been done. I wouldn't think it 
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 117 would make a large difference. 

 DR. ZIEMER: Intuitively I wouldn't think 

so, either. I just wondered if anyone had actually 

tested it. 

 DR. SCHUBAUER-BERIGAN: It might be that 

it's been tested as part of the NCI's development, 

but we didn't do that for NIOSH-IREP. 

 DR. ZIEMER: Thank you. 

 DR. SCHUBAUER-BERIGAN: Lastly, there was 

some criticism of the use of the same RBE 

distribution for leukemia as for all solid tumors, 

and this led to the use of a hybrid distribution 

that actually adds weight to lower RBE's based on 

human evidence primarily that the leukemia RBE's 

might be lower. The compromise here is that since 

there is substantial uncertainty, this distribution 

is linked with the general solid tumor distribution 

so that those are combined to produce a separate 

distribution. 

 Since you've heard about the NCI's program, 

I wanted to talk a little bit about how NIOSH-IREP 

differs from NCI-IREP, and you'll see that most of 

the differences stem from the mandate that we were 

given under EEOICPA. We're back on the slides now 

that you have. 

 Well, first, the most important point is 

that the two versions of IREP agree very 
substantially. There's very little difference 

between them. There are, however, differences in 

risk coefficients that are used for certain cancer 

models, namely malignant melanoma of skin and male 

breast cancer. I'd like to show you these 

differences and what led us to use these unique sets 

of coefficients. 

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 In our subject matter expert review there 

was some criticism of our decision to use basal cell 

carcinoma risk coefficients for malignant melanoma 

cancer. We turned to the recommendation of NCI-IREP 

to help us decide what to do here. They don't, 

however, recommend any particular model at all for 

malignant melanoma. There is no model in NCI-IREP. 

 We decided to stay with the use of the basal 

cell carcinoma model for several reasons. First, 

from the A-bomb survivor studies conducted by Elaine 

Rahn and others, the point estimates for malignant 

melanomas are very similar to those for basal cell 

carcinoma. And there was also evidence from nuclear 

worker studies of an association between radiation 

exposure and malignant melanoma. Therefore we 

determined that it was appropriate to use a model, 

to have a model to estimate probability of causation 

for malignant melanoma, and we needed to decide 

which was the most appropriate model to use. 

 The two models we believed to be relevant 
here were the basal cell carcinoma model and the 

residual cancer model. This graph is quite complex. 

 I'll orient you to it. It shows the upper tail of 

the distribution of the ERR per Sievert for two 

different models at various ages of exposure and 

diagnosis. Age at diagnosis is along the X axis. 

The triangles show the results for the basal cell 

carcinoma model, and colors that are the same 

indicate, for the two models, the same ages at 

exposure. So initially what you see is that both of 

them show higher risk coefficients for younger ages 

at exposure. This first blue line is age 15 -- or 

I'm sorry, age 20, age at exposure. The sort of 

purplish line is the result for ages at exposure of 

30, and then this line at the bottom is ages greater 

than or equal to 30. There's no change after age 

30, age at exposure. 

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 As you'd be able to tell if you had time to 

look at this, in every case the basal cell carcinoma 

risk coefficients are higher than those for squamous 

cell carcinoma, and we felt it was consistent with 

the policy we had applied elsewhere to, when there 

was doubt about the appropriate -- two 

scientifically-appropriate approaches, we would use 

the one most favorable to the claimant, and in this 

case that is the use of the basal cell carcinoma 

risk coefficients. 
 120 We applied the same reasoning to male breast 

cancer. Our approach in the initial NIOSH-IREP was 

to use female breast cancer risk coefficients 

applied to the background incidence rates for male 

breast cancer. This was questioned by one 

scientific reviewer, who suggested that we use the 

miscellaneous category. This indeed is what NCIIREP has done. They have male breast cancer 

included in the residual cancer model. 

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 However, our final version of NIOSH-IREP 

retains the use of the female breast cancer 

coefficients for virtually the same reasons as I 

alluded to earlier. Male breast cancer, we feel, is 

hormonally related and in that sense it's an 

appropriate approach to consider using female breast 

cancer coefficients. The residual cancer model 

produces generally lower risks per unit dose at the 

upper tail of the distribution than does the female 

breast cancer. And here it's much more difficult to 

see because at young ages of exposure the two models 

produce very similar risk coefficients, seen here in 

the red lines, the blue lines and the green lines 

for comparable ages at exposure. 

 So given our policy intent to give the 

benefit of doubt to the claimant, we decided to use 

female breast cancer risk coefficients for male 

breast cancer. 
 

 Continuing on the list of ways in which 

NIOSH-IREP differs from NCI-IREP, we use individual 

models for the miscellaneous categories. We split 

them into their individual cancer types, which are 

connective tissue, eye, non-thyroid endocrine gland 

and ill-defined cancers. These use a common 

estimate of the excess relative risk per Sievert, 

but the risk transfer function uses the background 

incidence rates for the specific cancer site. 

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121

 There are also some differences in 

application, primarily designed to make the 

determinations as objective as possible, providing 

again the benefit of doubt to the claimant when 

necessary. First is the use of objective lists of 

cancer models for claims in which the primary cancer 

site is unknown. NCI-IREP doesn't speak to that 

issue. 

 Again, we have the required use of two 

leukemia models for certain leukemias, and this is 

generally done in the case where we're uncertain 

whether the subtype of leukemia is more important 

than age at exposure in being an influential risk 

modifier. 

 We also developed a set of operational 

definitions of smoking history for the lung cancer 

models. 

 I'd like to touch on some of the potential 
1 future modifications that we can envision at this 

point resulting from new scientific information. 

First, it's always possible and highly probable that 

there will be improvements in the risk models, or 

adjustments of the uncertainty distributions. Some 

examples that have been mentioned by NCI include the 

update of risk coefficients from the Japanese atomic 

bomb survivor incidence cohort, which is expected 

around the same time as BEIR VII. Also we do 

anticipate that input from epidemiologic studies of 

nuclear workers, which played a very small role, if 

any, in the NCI-IREP program, will become a more 

important part of NIOSH-IREP in the future. 

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 It's always possible that changes in 

dosimetry practices could lead to changes in NIOSHIREP. The adjustment for temporal changes in U.S. 

cancer rates is a feature that we would really like 

to see added to NIOSH-IREP. 

 And several individuals and the NAS panel 

that reviewed the NCI-IREP recommended some 

consideration of adjustments for radiosensitive subpopulations. We were not able to do that at this 

time because of the state of scientific evidence, 

and the practical limitations in actually 

determining who is radiosensitive precluded our 

ability to do that. 

 Adjustments for other -- for interactions 
with other work place exposures is an avenue we 

believe requires further investigation. The 

assumption in NIOSH-IREP is that these interactions 

are multiplicative. That is, your excess relative 

risk doesn't depend on what your -- for example, 

your chemical exposure history is. 

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 In summary, we made several modifications to 

NIOSH-IREP in response to both public and subject 

matter expert comments. These include the 

modification of risk coefficients for bone and skin 

cancers, the use of certain risk transfer functions 

for skin cancer and for male breast cancer, the 

adjustment of DDREF and RBE distributions. We 

justified our modifications in the final PC rule and 

also in the final technical documentation of NIOSHIREP, which will be available very soon, along with 

NIOSH-IREP itself. It will also be available -- 

this documentation will also be available on-line. 

That's a charge that we take very seriously because 

we believe that that will lead to increased 

understanding of how the probability of causation is 

actually calculated. 

 As you're aware, future modifications will 

be formalized and are subject to review and comment 

by you, the Advisory Board on Radiation and Worker 

Health. And with that I will finish and take 

questions. 
 DR. ZIEMER: Thank you very much. Who 

wishes to raise a question first? 

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 DR. MELIUS: First a procedural question. I 

believe that -- I remember back to the first few 

meetings -- the committee agreed that we would 

review the current IREP in more detail, and that we 

were giving approval to the general concept and many 

of the principles involved. And I guess I'm trying 

to get a handle on procedurally how we would go from 

here. There are these scientific expert reviews 

that have been done that we've not been given access 

to yet. I presume we will at some point soon. Some 

of them clearly aren't finalized yet. And how do we 

bring this together procedurally into a -- into the 

function of the committee? And I don't know, Larry, 

if you've given thought to that or -- all or -- how 

we're going to proceed. I guess my point here is do 

-- we can ask a bunch of questions, but we've not 

been given full access to all the information yet 

and I don't want to sort of have Mary have to relay 

this expert said this and this and that. I think 

she's done a very good job of summarizing the 

information and fairly, but I think at the same time 

as a committee we have a responsibility to go into 

more detail at some point if we're going to be 

dealing with future modifications as well as some of 

the issues that may arise from the application of 
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 125 this final model. 

 MR. ELLIOTT: Certainly your points are 

well-taken and we have thought about this. Given 

the push to put this in place so that claims can be 

adjudicated in the Department of Labor, we need to 

set the milestone -- the starting point or the -- 

put this in concrete, if you will, as to what will 

be used by Labor to calculate probability of 

causation on completed dose reconstructions we send 

to them. You certainly have not seen all of the 

subject matter expert comments and that's part of 

the documentation for the IREP that Mary's referred 

to. It is being finalized. The IREP itself, with 

these minor changes and modifications that she's 

iterated for you, are being completed this week. We 

hope that it'll be in place next week, and then by 

the following week or so, after we've got clearance 

from claimants on OCAS-I forms, to be able to 

transmit that information on dose reconstruction to 

the Department of Labor and they will use this IREP 

to adjudicate those claims. 

 So I guess this is your starting point. Any 

additional details and information that you want to 

see and you need to see, we're certainly ready and 

willing to provide that to you, and we want your 

thoughts and your input as to what you would 

recommend changes should be from that point on. But 
this will be the starting point for claims to be 

adjudicated from. 

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 I don't know that I answered your question, 

but... 

 DR. MELIUS: I still have a procedural 

question and would just point out that while we 

understand the need to get this in place to do, it 

is subject to our review and recommendation for 

modification, and that modification may be -- come 

sooner rather than later. We're assuming it'll come 

later and some of that will deal with further 

scientific study. But I think we need to -- as a 

committee to come to grips with some way of 

reviewing this information and coming to grips with 

it and not -- not in this -- you know, we've got 

this repeated pattern of sort of last-minute -- you 

know, here it is; approve it. And I think we need 

to get out of that at that mode and I guess that's 

what I'm -- 

 MR. ELLIOTT: Well, you are out of that 

mode. You are out of that mode. When this is set 

next week, this will be the NIOSH-IREP. And from 

that point on, whatever recommended changes you 

have, we'll take under consideration. Whatever 

information needs you have to determine what 

recommendations you would like to provide, we will 

assist you in getting that information. 
 DR. MELIUS: Just that I'm personally 

uncomfortable with much of this information not 

being shared with us at -- ahead of a meeting so we 

can have a very reasonable discussion without again 

wasting a lot of time and effort and not without 

putting all the pressure on Mary to relay to us all 

this separate information. And I think we need to 

be provided with this information sooner rather than 

later. 

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 MR. ELLIOTT: Well, we're providing you the 

information almost as it is made available to us. 

We're making policy decisions, as Mary's indicated 

today, and it's certainly your option and the Board 

has the responsibility to react to what we've done 

to date and to seek additional information for your 

better edification of the details behind this, and 

we'll provide that to you. So I hear you loud and 

clear. Believe me, I have a lot of empathy because 

we are living with this on a day-to-day basis 

ourselves. 

 DR. MELIUS: Then I'd like to open up for 

Board discussion, before we ask Mary questions, 

about what will be our process and procedures for 

doing this. 

 DR. ZIEMER: We're sort of asking ourselves 

that question -- 

 DR. MELIUS: Well, again, no, I'm not -- 
 DR. ZIEMER: 12 -- in the sense of what we're 

doing, but -- 

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8

 DR. MELIUS: I'm not saying I have the 

answers or -- 

 DR. ZIEMER: -- let me throw in some 

comments here, because it seems to me we have to 

distinguish between the sort of -- I will describe 

it as the program that grinds out the calculation 

and the underlying assumptions. I don't think any 

of us want to get into how they're doing the 

program. We're more interested in those underlying 

assumptions which involve, number one, the dose 

reconstruction and the distribution of 

uncertainties, and those -- because there's a number 

of models here. We have said that we will accept 

the ICRP-60 models, for example, and so that's kind 

of a universal thing for a certain piece of this 

calculation. 

 There are some assumptions about uncertainty 

distributions and dose distributions which are 

default assumptions, in the absence of real 

information about what the true distribution is. So 

it's those kinds of things I think we almost have to 

categorize them and say okay, are there some things 

in terms of risk coefficients that we're 

uncomfortable with; are there things about the dose 

rate factors; are there issues with assumptions on 
the form of the distributions and that kind of 

thing. 

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 Now over the past couple of meetings, the 

two previous meetings here, we've certainly received 

that information, at least in general terms, and in 

fact have had a chance to try out the IREP as it has 

been developed and sort of get a feel for the effect 

of changing parameters and so on. It's not clear to 

me that this committee is in a position to sort of 

fully bless the IREP. The IREP's simply a tool for 

them to carry out the calculational part of all of 

the other stuff. So it's not clear to me if you're 

concerned about IREP as a methodology or some of the 

underlying assumptions as I described them -- or 

both or neither. 

 DR. MELIUS: Well, it's probably both. But 

my concern is that we keep hearing today -- and I 

don't think it's inappropriate, but it is disturbing 

as an advisory committee. We keep hearing today 

that well, we got expert review and based on that 

and based on consensus, discussion, whatever, we 

made these changes. Well, we haven't gotten that -- 

seen that scientific review, and I do think, while 

we may not have the depth of expertise in a 

particular area that some of these outside experts 

have, I do think we -- I think to some extent have a 

responsibility for reviewing was that incorporation 
appropriate or not. And I can't do that in the 

abstract. I can't -- again, not that we distrust 

the NIOSH staff or doubt their ability, but I think 

we do have some responsibility to look at those 

reviews, were those appropriately weighed and ask 

some questions. And it's very hard to do that in 

this context when they have all the information and 

we have none. 

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 DR. SCHUBAUER-BERIGAN: Can I just make one 

-- 

 DR. ZIEMER: Please. 

 DR. SCHUBAUER-BERIGAN: -- statement? It's 

not correct to say that you have none. You probably 

have about 75 percent of the subject matter expert 

reviews. At least they were made available on the 

NIOSH-OCAS web site. The exception is the RBE and 

DDREF distribution. And if that's what you're 

referring to, then yes, there is a set of subject 

matter expert comments that have only become 

available -- Monday, as of Monday. I mean it's been 

an extremely tight turnaround on those. So you do 

have many of them. And if you'd like to cover 

issues that don't pertain to either DDREF or the RBE 

distributions, you've got that information 

presumably and that -- those have been made 

available since about January, I believe. 

 DR. ZIEMER: Let me ask if there are 
131 additional questions or maybe any reactions to what 

Jim had to say? Tony? Oh, I'm sorry, Henry, you go 

ahead. 

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 DR. ANDERSON: Yeah, I just -- you know, 

it's one thing to have the reviews and not -- that's 

very helpful once we get those and have it on-line, 

but I think what also would help me is -- and just 

not to pick on it, but you've made some changes to 

the DDREF and you're saying that's based on reviewer 

comments. I guess what would be valuable to me, as 

well, would be well, how did you distill those 

comments? Was it unanimous that they felt you ought 

to just slightly modify this or how did you arrive 

at what now is a slight difference from the NCI 

DDREF and then why was this particular one chosen? 

Is there a science basis for this? Is it a policy 

decision? We heard this morning Dr. Land saying if 

you -- at least I took it as maybe a poor man's 

sensitivity analysis, but the major impact in this 

whole process is the choice of the DDRF and if you 

use the human epi data and you use one versus you 

use two, and now they went somewhere in between and 

you're also going somewhere in between, and the 

question is well, is that -- is your choice, which 

is different than either of the others, is that a 

policy decision? Is it a -- is the science -- what 

studies clearly indicate that this -- I mean that's 
the kind of -- what are -- we've seen what your 

decision is and we've heard -- we can read what some 

of the comments are, but we haven't really heard 

particularly what the rationalization is other than 

well, we weighted it a little bit more towards one. 

 How much of a difference did that make? And if you 

looked at what the possible doses you'd fit into 

this, does that now on your expectations increase 

the number of people that might meet the 50 percent 

criteria or doesn't it have really any impact at 

all? I think that ultimately -- this committee I 

think down the line we're going to want to say well, 

had you used a different factor, have we now, up 

front, eliminated a whole bunch of people from 

compensation by adjusting it just at the margins 

because we don't have what some of those 

distributions might be. I don't know if anybody's 

looking at that or if it's just a priori decision. 

I guess that was -- I'd like to know was it uniform 

by your experts to say that instead of this figure 

it ought to be 1.8765 versus two versus one, and on 

some of the others -- those kind of issues as to 

what was your thinking. Not that you made the wrong 

decision. The decision had to be made; you're 

moving forward. But it's hard for us to understand 

was there unanimity in your experts, just as we 

heard the public comments were all over the map, 

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133 this way, that way, and you then decided to go this 

way, but we haven't really heard the rationale for 

it, at least I don't understand it. 

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 DR. SCHUBAUER-BERIGAN: Okay, I'll answer at 

least one aspect of your complex question, and that 

is that at this point our DDREF distribution is the 

same as the one that NCI is using. We haven't 

changed theirs. It's different from the one that we 

had in the program as the initial NIOSH-IREP, the 

draft NIOSH-IREP. But it was made on the basis of 

-- it wasn't made on the basis of consensus with 

our subject matter experts. 

 We didn't have any kind of group meeting of 

these people. In fact, I don't think we are 

permitted to do that for this process. We did get 

expert opinions. And those of you who work in the 

field of science know that it's very rare to have 

two people agree on anything, especially if they're 

coming at an approach without discussing it among 

themselves. So I wouldn't say that there was 

unanimous agreement among our subject matter experts 

about any particular change that needed to be made. 

 In this particular instance, we concurred 

with NCI -- which is important for distributions 

that are common to both the program they're 

developing and the program that we're developing -- 

that it was more appropriate to more heavily weight 
a DDREF of one. Now this has the effect of 

generally increasing a claimant's chances of 

receiving compensation. 

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 But there were instances where changes were 

made that went in the other direction. And the 

process of distilling those subject matter expert 

reviews is a completely separate question and I 

don't know that there is a document that's produced 

that addresses all of the subject matter expert 

comments that's in development, which will hopefully 

address many of the questions that you raise. 

 And Larry, I don't know if you had anything 

to add to that. 

 MR. ELLIOTT: Well, what I would add is that 

where we use science to the fullest advantage and we 

still have a decision to make, the policy decision 

comes to play and that, each and every time, has 

been to examine what's the more claimant-friendly 

approach, and that's the one we then decide to use. 

 And in the documentation we will speak to that 

point, when and where we make those decisions. And 

again, we don't have that available for you today. 

 As Mary said earlier, we have shared those 

subject matter expert comments on the different risk 

models that we were employing, different 

coefficients -- yeah? 

 DR. SCHUBAUER-BERIGAN: And the initial RBE 
135 distributions. Those have gone through two separate 

subject matter expert reviews and you've received 

the first set of reviews. 

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 MR. ELLIOTT: I would also add, and I think 

this is accurate and fair to say -- correct me if 

I'm wrong, Mary -- but the subject matter expert 

comments that we received in not all cases were on 

the similar issues -- similar items, similar 

concerns. You know, they were cross-cutting. So in 

that regard, too, without having enjoined everybody 

who was a subject matter expert to discuss this, 

you know, it would have been very difficult to reach 

consensus even on those ones that they individual 

identified. 

 DR. ANDERSON: Yeah, I -- I guess it's more 

of a process issue is you're living with this day-in 

and day-out. And you know, when you say it's been 

made available, it's kind of like saying well, it's 

in the library. You know, all literature's in the 

library. You can find it if you want to take 

exception. As opposed to having you help us distill 

from the reviewers' comments what were the critical 

issues as opposed to reading them and seeing they're 

all over -- you know, if we're going to provide 

advice, you need to think about what is the 

information that we need in order to give you 

valuable advice from a broad set of backgrounds that 
136 we have here, and that's partly what I'm just saying 

is it's -- maybe it's coming, but then our advice is 

at a different point than we haven't really been -- 

maybe it's just that it's evolving. We haven't been 

involved in those discussions -- decisions of 

getting up to speed. It all kind of comes -- 

decision -- here's what we've done, and what you 

explain has been done is rationally put together, 

sounds very reasonable. But we really don't know 

what were the various options and decisions as you 

went through it and then if you'd come to us and 

said well, here's a couple of -- here's a fork in 

the road, here's a couple of things, what do you 

guys think about this or that, you may have gotten 

-- just like you did from your experts -- this and 

that. Then you say well, you know, that's 

marginally helpful and you move on. So it's more as 

we move forward how is -- how are we going to feed 

into -- or get the information to be able to provide 

you with that kind of advice. 

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next and then Wanda. 

 DR. ANDRADE: I'd like to offer a partial 

solution to this dilemma. I, too, feel like Dr. 

Melius that changes are being made without a full 

vetting. Now this is not to say that we need to 

second-guess the subject matter experts. As a 
1 matter of fact, I doubt that this body would even 

like to. We're not an expert body. We're an 

Advisory Board. 

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 37

 However, there are changes, such as to DDREF 

and RBE's, that are important to me. And there are 

perhaps other factors that are important to members 

of this Board. Perhaps we could express our concern 

regarding certain of these distributions or some of 

these factors, and that we could at least take time 

in near future meetings to at least discuss the 

context within which changes were made and why a 

certain way was chosen rather than another. 

 I mean for example, you offered up today 

that it's important to be consistent with NCI. 

Well, that's -- that's okay, to a certain extent. 

But let's say in other cases -- in DDREF's, for 

example -- were changes made because of the latest 

paper that's out from some epi study? Was it the 

result of a compilation of many studies over many 

years that indicate that things should be tending 

toward -- down towards one? Or are we just being 

conservative? I'd like to know the context within 

which these decisions are being made. 

 So perhaps members of the Board can write 

down and provide directly to OCAS those areas in 

which they would like to at least hear, again, the 

context in which changes were made so that we can 
either accept them comfortably or question them, 

rightfully so, and I think that is within our 

charter. 

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 DR. ZIEMER: Wanda? 

 MS. MUNN: If I understood correctly, the 

original question was a procedural one. I don't 

personally believe that it's appropriate for this 

Board to insert itself or our activities in the 

ongoing process that other agencies are involved in 

right now. I personally very much appreciate having 

what I consider advance information provided for us 

at this meeting. I know most of this is hot off the 

press, as you said, and I'm very pleased to know 

that this is what's transpiring. 

 In earlier discussions about process we 

pointed out that it's possible to get some of this 

information to us electronically, sometimes perhaps 

only hours before we're meeting. But if that's 

possible to incorporate in the process whenever it's 

available, then that's to the benefit of all 

concerned as long as it does not interrupt the 

ongoing process of the agency in attempting to bring 

these things to an operable point. 

 I would suggest that it might be appropriate 

for us to ask that we be allowed to have at least 

the rudiments of any changes that are being made 

early on. Other than that, until the agency has 
139 made its decision with respect to how they're going 

to deal with it, I don't believe we have anything to 

advise about, personally. So I would -- I guess my 

bottom line is I would suggest if information about 

relative changes are going to be available, even a 

few days beforehand, if this Board could be advised 

electronically of it so that we would know that the 

presentation is coming and know what to expect, and 

I think that would be helpful. 

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 DR. ZIEMER: Thank you. Any other comments 

or suggestions? Or questions? 

 MR. ELLIOTT: If I may, let me just sum up. 

 I think what I heard -- and I want to make sure 

this is duly recognized -- that we need to get to 

you not only the final information, but information 

that's being developed as we feel that it's 

appropriate to deliver to you. We should get that 

to you not only electronically, but we should send 

it to you by hard copy so that you have it as soon 

as it's possibly available. I hear that we need to 

identify for you -- and I hope that we could work 

together in this identification process -- what 

things you need to know about or hear about, what 

issues you want to examine in more detail, and you 

want to advise on and recommend upon those levels of 

detail and those different issues. I think -- and I 

hope we can agree on this -- that this is a starting 
14 point, and what we need to do from this point with 

this final NIOSH-IREP is determine where you want to 

examine it in more detail, provide more information 

to you about that. We need to get you the RBE 

radiation weighting factors documentation document 

now that is being developed. We need to get you the 

subject matter expert comments on the DDREF and the 

weighting factors that we have that you've not seen, 

and then perhaps we need to include that as an 

agenda item in the next meeting or however you wish 

to take it up. 

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 0

 I think those are the things I heard and I 

just want to make sure that we agree that that's 

what was said and we can move forward. 

 DR. ZIEMER: I think I'll pursue that in 

just a moment. Let me insert here -- and then 

Henry, you can have some additional comments -- we 

certainly want to find a good balance between 

micromanaging the staff and doing our job, which is 

advisory, granted, but looking out after the broader 

interests almost nationally of how this law is 

administered. In that context, since the IREP 

becomes a key part of how the thing is conducted, I 

think the Board -- at least it's clear from the 

comments -- needs to at least reach a comfort level 

as to how the staff is going about developing the 

final product that will be used. Whether or not we 
141 officially bless that, piece by piece or as a whole 

or whatever we wish to do, there's clearly some 

level of discomfort with the process in reaching the 

final thing here. It might be helpful in fact, and 

we will have time to do this since the next item on 

the agenda is one we announced at the front end 

isn't going to happen today, that we take some time 

to identify specifically the issues on the IREP that 

are of concern. I think we have a partial list now 

and there may be some other items. 

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 With that comment, Henry, you had an 

additional one? 

 DR. ANDERSON: Yeah, I guess my -- and if 

we're moving forward, it's then where is advice 

helpful? My feeling has been advice on a fait 

accompli, you know, is not very helpful. And to 

this point are we been -- we've been asked to 

comment and provide advice after you've already 

formed your official position. So once NIOSH has 

decided here's our document, then advice is more 

difficult to have it fit into there because it then 

almost gets into well, it's a defensive sort of 

thing -- well, we did it because of this -- and then 

we're attacking what we think is different rather 

than being part of the team and saying here's the 

various options we're considering. 

 I mean you've already considered the 
1 options. You've made your decision, and then you 

come to us and now -- I mean with this, again, it's 

-- we went through the two rules and I read here 

we're prominently quoted as signing on to say this 

is a great thing and our Board has got this, you 

know, high position of comment, but we're really not 

advising on here's the decisions that you're making 

as you go through this process. Here's the options 

and then here's our rationale for it. Now as we 

move forward again, once you have this in place, 

then my sense would be, and my experience with rules 

and everything else, once you've established the 

first one, making the changes, the bar that you have 

to get over, that hurdle to make those changes 

unless they're minor, becomes more difficult because 

you now have all of the past experience and the past 

thing to build on so that the time to be sure that 

everybody's up to speed is early on while we have to 

live with the circumstances, but we now have other 

things coming up. And I just want to be sure that 

if we're going to be in this for the long term that 

we learn up front so what are you thinking about, 

what are your thoughts on new literature coming up 

and that, before you come to us and say well, we've 

decided to make a change; what do you think about 

it. Once you've made your decision, it becomes -- 

at least I've found when I make a decision it's much 

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 42
more difficult for me to change that once I have 

vetted it through internally to hit all the hurdles 

to get everybody to sign off on it, and now you come 

along and say I want to change this a little bit. 

It's much more difficult. 

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 MR. ELLIOTT: I think what I hear you 

saying, though, Dr. Anderson, is an artifact of the 

process. We're so rushed to get this put in place 

so that claims can be adjudicated. And what we're 

saying to you is that -- and we've said it I think 

all along, IREP has been held apart from the rule, 

and we accept comments on IREP from now on. We're 

asking for you to -- we're not asking for you to 

bless IREP today. We're presenting IREP today with 

our decisions, policy and scientific-based 

decisions, and saying here's the starting point. 

And I'm asking you to help me and help my staff 

understand what additional issues you want to 

explore for any modifications from this point or how 

to handle comments that we might receive from 

technical commentors or the public on IREP. 

 Unfortunately, we've had a rough time of 

trying to balance the need to put this in place and 

bring the Board along in their understanding of 

these very technical and complex dynamics of 

probability of causation and dose reconstruction. 

Again, the rule is the rule now. IREP can be 
144 changed, and we look forward to working with you all 

on that. 

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 DR. MELIUS: I just want to clarify -- 

really it's not an artifact of the process but an 

artifact of how NIOSH chose to manage the process, 

and I think we understand the need to be able to 

handle claims and so forth, but frankly I don't 

think the committee's -- at least personally, I 

would not endorse what these changes that you've 

made because I don't think we've been given a fair 

opportunity to review them. You've decided to 

manage our review in a way that we haven't been 

given that opportunity. 

 I think what we should say if we're going 

forward is that we ought to, as Tony suggested, 

identify certain issues that we want to spend more 

time reviewing, that we should review the comments 

that have come in, see if other experts maybe 

outside our field would have raised some issues that 

we really think need further discussion and maybe we 

need to bring those experts in to hear from them and 

better understand certain issues that maybe we don't 

think are a problem but -- or don't need to be dealt 

with, but they do, in order to make this work 

properly. And I think that should be the process 

for going forward. 

 I think what does disturb me even more is 
1 the change you're just making in the agenda now. 

We've gone from a day on Special Exposure Cohorts 

guidelines -- at least from what I read, the 

modified agenda was an hour and a half discussion of 

them, to now -- if I understand what Paul just said 

-- to no discussion. And we're going to be, I 

presume, presented with some set of guidelines some 

months from now to review, having missed the 

opportunity for this meeting and earlier meetings 

for any sort of discussion or input into that 

process. And I don't think that's a fair use of 

this committee's time or talents. And that pattern 

does bother me. These are not -- Special Exposure 

Cohorts are not regulations. There should be no 

prohibition against discussion of a number of the 

issues related to those, and now we're being told 

presumably that there will be no presentation or 

discussion of those. And I think there has to be 

some recognition of how NIOSH wants to work with 

this committee and to not have us become a rubber 

stamp or have to rush through a process of reviewing 

something. Because if those Special Exposure Cohort 

guidelines get presented to us in two months, I can 

assure you that you'll be telling us that you really 

need to rush and get them out and get them in place 

'cause claimants are awaiting. Well -- and we'll be 

given, you know, two days or a day and a half or 

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 45
14 whatever the meeting is to review them and I don't 

think that's fair to us or it's fair to the process, 

nor is it fair to the claimants and what was 

envisioned by Congress in setting up this Advisory 

Board. And I think we need to come to grips with 

that larger issue, also, in addition to what we just 

talked about in terms of the IREP. 

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 DR. ZIEMER: Tony, did you have another 

comment or -- 

 DR. ANDRADE: No. 

 DR. ZIEMER: Okay. 

 MR. ELLIOTT: If I could react to Dr. 

Melius. I'm not precluding you, as the Executive 

Secretary, from discussing Special Exposure Cohort 

procedures. But we made it clear in the e-mail that 

I sent around, I thought Dr. Rest made it clear this 

morning, we don't have anything to present to you on 

what those procedures look like today. So you're 

certainly welcome if you want to use your time this 

afternoon as a Board to discuss what you think are 

the critical, salient issues surrounding the Special 

Exposure Cohort petitioning process, but we are not 

in a position to share today with you what those 

draft procedures look like. 

 DR. MELIUS: Then can you explain to me why 

Ted Katz is listed at 2:15 to present on Special 

Exposure Cohort guidelines in this modified agenda? 
 MR. ELLIOTT: 147 Well, that unfortunately was a 

mistake that got sent out as a modified agenda. 

It's a mistake that it was in the book. We didn't 

catch that early enough to take it out and replace 

it. We were scurrying around this morning trying to 

find the modified agenda that had been approved and 

we don't have it for you today. All we can say is 

we do not -- as Dr. Rest indicated this morning, we 

do not have the draft procedures available for your 

review today. If you wish to discuss SEC 

petitioning process and what your thoughts are about 

how that should be conducted and performed, that's 

certainly your option. 

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 DR. ZIEMER: Let me also insert -- in fact, 

about -- I guess it was about a week ago that Larry 

indeed indicated to me that they would not be able 

to present on this and that item was to have been 

taken off the agenda. And when the final copy came 

to me at least, I myself didn't notice that it was 

still on the agenda, but I know it was the intent of 

the staff to have removed that from the agenda. In 

any event, it's as just described. 

 Now let me ask the Board at this point, 

would it be of value for us to go ahead and clarify 

and identify issues on IREP that individuals would 

like to see information on, specifically such as the 

things you mentioned, Tony. Can we do that now? 
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 148 Would you find that useful to do right now? 

 DR. ANDRADE: Paul, at this particular point 

in time I'd rather us agree on a process and perhaps 

for the next meeting be able to discuss some of our 

individual concerns or have reps from NIOSH be able 

to discuss how some of these decisions were made on 

some of the important factors. 

 However, I wanted to pursue the issue that 

Dr. Melius brought up again on -- or regarding the 

draft procedures. I would find it perfectly 

acceptable to have an impromptu, informal, not even 

finally-prepared discussion on just what sorts of 

questions are being thought about, what issues are 

being contemplated with respect to these procedures 

before even -- before they're even put down in draft 

form. So I'd say that scheduling informal 

discussions for the future should not be out of the 

realm of this Board's deliberations. 

 DR. ZIEMER: Mark? 

 MR. GRIFFON: And I really just wanted to 

pick up on that point that Tony just made. I would 

reiterate that and I would even say that the statute 

mandates that this Advisory Board be involved and 

give input into the development of policies, rather 

than simply their review after policies are a final 

product. So I would reiterate that and would also 

ask for -- I think that'd be a valuable discussion 
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 149 to have on Special Exposure Cohorts. 

 The other thing in terms of the process for 

the other stuff, for the IREP model, I think that it 

would be valuable to come up with topics -- I'm not 

sure I'm ready today. I have some ideas, but it 

would be valuable to have some topics and have some 

maybe experts come in to present. I like the ideas 

that both Jim and Tony presented. 

 Further than that, I think in the preamble 

of the regulation it says -- it has a phrase in 

there that basically says that the Advisory Board 

will review the current NIOSH-IREP, so I think we 

also have a responsibility to, in some way as a 

Board, put out a final review of the model, too, so 

that should be maybe the end product of this 

process. 

 DR. ZIEMER: Any other comments? I think we 

can let our speaker sit down, at least, since we 

apparently have no more questions for you. 

 Mark, did you have another question? 

 MR. GRIFFON: No. 

 DR. ZIEMER: No, oh, okay. Jim, you have 

another comment? 

 DR. MELIUS: Next time maybe it'll stay 

raining in Cincinnati. 

 Yeah, I agree we ought to -- I think it 

would be fair to discuss Special Exposure Cohort 
15 guideline. I'd just point out that we'll be going 

-- be doing this while at the same time there's a 

document being circulated with what NIOSH's proposal 

is and that other people are commenting on that -- 

we're going to have sort of a parallel process, and 

I'm not clear that we're really being provided any 

input, but I think it would be worthwhile discussing 

that. 

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 I think there's another issue that we have 

talked about briefly at the last meeting that I 

think was worth spending some time on and that is 

how is the Board going to review the dose 

reconstructions that are done? And I think we sort 

of have to make a decision towards the managing our 

time for the rest of the day and a half in terms of 

how to divide up some of this and my understanding's 

-- I don't believe David Michaels is in town today, 

but will be in tomorrow, so we're sort of caught 

with that time for his presentation. But I think if 

we could sort of regroup and decide how to spend our 

time for the next few days to make it -- or next two 

days to make it a useful use of that time I think 

would be helpful. 

 DR. ZIEMER: Thank you. Let me ask -- I 

guess I'll ask Tony. The question when you raised 

the issue of process, were you talking specifically 

about dealing with the IREP at this point or more 
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 151 generally or generically? 

 DR. ANDRADE: Paul, I think I was talking -- 

well, I was talking about the way this Advisory 

Board functions and -- more generically, right. 

 DR. ZIEMER: Well, let me again, though, 

raise the question then, because we can finish up on 

this IREP topic and go ahead and identify issues or 

-- and then move on to the more generic question, if 

you wish. I mean -- leave it up to the Board 

because it's -- it's not something the Chair does 

unilaterally. I don't dictate our direction here. 

Sometimes I figure out where the Board's going and I 

try to get in front of them so I look like I'm 

leading it. 

 DR. ANDRADE: Paul, I understand the -- 

well, the reality of the situation. And again, I 

already mentioned the topics that are of most 

interest to me with respect to IREP. But I 

understand also that the representatives here from 

NIOSH are perhaps not ready to present to us, even 

in a five-minute informal manner, a discussion on 

the context in which some decisions were made with 

respect to dose and dose-rate effectiveness factors, 

and that's all we want to do. That's all I want to 

do and that's all I'd like to see the Advisory Board 

do is not micromanage the scientific process, but 

understand the decision-making that went on behind 
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 152 it. 

 DR. ZIEMER: Yes. I think that's 

understood, and some of that might be able -- they 

might be able to address yet today. Or if there is 

-- if the answers are not complete, to come back to 

us. But as a starting point, can we identify the 

specific items? Let's start out with what, doserate effectiveness factor? 

 DR. ANDRADE: Absolutely. 

 DR. ZIEMER: What else? Did you have -- is 

that the issue for you, Tony? 

 DR. ANDRADE: And RBE's. 

 DR. ZIEMER: And RBE's. Any others? Mark, 

Jim, Richard, Robert, Roy, Sally, Henry? 

 DR. ANDERSON: Just the DDRF's. 

 MR. GRIFFON: I think there's others that I 

also understand are more long-range issues, but 

there are other issues such as age at exposure that 

I understand probably the current thinking leads 

them to decisions made in this model, but -- I don't 

know if we're making a full laundry list of issues 

within the realm of this program or -- 

 DR. ZIEMER: Well, I don't think at this 

point we're at a point where we want to speculate 

where the IREP may be two years from now and 

anticipate. But I think it has to do with decisions 

that are being made almost in real time on some of 
these particular factors, such as identifying -- 

apparently the staff is preparing to discuss some of 

those even today in more detail. Is that correct? 

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 153

 DR. NETON: Yeah, I'd just like to interject 

something here. I've been listening to this 

conversation with some interest, and I'd just like 

to point out that the Act requires us to use the 

Interactive RadioEpidemiological Program or its 

predecessor -- you know, its subsequent versions, 

which is the NCI-IREP. We are allowed to make 

modifications that are specific for our cohort, 

which we've done. 

 As far as DDREF and RBE, it is a virtual -- 

it's almost certain that we will have the same DDREF 

and RBE distributions as the NCI-IREP. There will 

be no difference. So to that extent, we are really 

adopting the NCI-IREP program. 

 I think the key things to focus on are the 

differences between us then and the NCI, which are 

the several areas that Mary pointed out, the risk 

coefficients for bone and skin, some of the 

different transfer coefficients that we've used. 

Those are the key differences in the programs. 

 That being said, you certainly have a right 

to review all of IREP, including NCI-IREP, but I'd 

just like to point out that if we adopt the NCI-IREP 

as part of NIOSH-IREP, then really we are in 
1 fulfillment of what's contained in the Act. Does 

that make sense? I mean it's not something where 

we're diverging, you know. I think it's part of an 

artifact in the sense that these programs are both 

being developed in parallel and to the extent we 

interacted heavily with NCI. But where we either 

make suggestions or modifications and they agree 

that it made sense, it became the NCI-IREP program. 

 So I'm not sure if that helps or hurts or -- 

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 DR. ZIEMER: I think the concern is that 

that's -- that appears to be sort of a closed loop 

now where it's not clear who's making the decision. 

 Is NCI accepting it 'cause you guys have proposed 

it or vice versa, and I -- it's sort of -- the 

unease is in that loop there. It's sort of saying 

well, there are some changes being made. At least 

let's learn why they're being made, do they make 

sense to the -- do they pass any kind of a ho-ho 

test or whatever. I don't think we're saying that 

we're necessarily second-guessing the experts, but I 

think we want to know why certain decisions are made 

and the basis for whatever changes are coming about 

almost in real time. 

 Is that a fair reflection of -- yeah. Go 

ahead, Tony. 

 DR. ANDRADE: Absolutely, if I might, Paul. 

 Jim -- right? Well, it's really nice that we're 
15 being consistent, but again, I am uncomfortable as 

to why. We're striving to be consistent and is that 

the reason that we're adopting these -- these 

factors, in and of itself, or is it -- or is there 

some deeper scientific basis? I'm just simply 

curious. 

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 DR. NETON: That's fine. I just wanted to 

point out that -- I think I heard that there was a 

belief that there were differences between our DDREF 

and the RBE distributions used in the NCI program. 

And the DDREF's are going to be the same. The RBE's 

have not been finalized, but it's my belief that the 

NCI -- and you heard Dr. Land this morning endorse 

the current RBE's as they are drafted -- so I 

believe that they will ultimately end up in there, 

although I can't speak for NCI. So I just want to 

point out that there are -- there's no difference 

between us and NCI in that area. So we're not going 

out there on our own modifying it for this cohort. 

I guess that's what I was trying to point out. 

 DR. ANDRADE: Okay. Yes, indeed, he had a 

wonderful talk this morning, and we all understood 

his endorsement. But I guess I'd like to know a 

little bit more about the basis for that 

endorsement. I mean he indicated but only indicated 

at a very high level that this is where scientific 

studies have -- are tending to shift the DDREF. 
Well, is that, again, the result of a paper, two 

papers, a collection of work that has been done over 

the last decade? I'd just like to know the context. 

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 156

 DR. NETON: I completely understand. I do 

agree with what Wanda Munn mentioned, though, that 

there are several agencies involved here and we of 

course do not control the National Cancer Institute 

and these things happen to be going along in 

parallel. So I think some of the frustrations being 

sensed here is somewhat out of our control in that 

respect. But with that, I'll sit down. 

 MR. ELLIOTT: If -- Jim, I don't know if you 

could speak to this or not right now, but if the 

Board is interested, can you talk about the subject 

matter experts comments on the radiation weighting 

factors and DDREF? Is there a way you can briefly 

summarize what they will see once we are able to 

pass that information along in hard copy and by email? 

 DR. NETON: I don't have the comments with 

me. I'd be reluctant to do them from memory, as old 

as I am nowadays. I can't remember as well as I 

used to, so I could give a hint as to what they are. 

 They were not extremely substantive. I mean there 

were some changes being made, but I -- I'd be 

reluctant to do them from memory, I guess. 

 DR. ZIEMER: Well, several items have been 
157 at least identified and perhaps could be followed up 

on. And are there other -- Jim, yeah. 

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 DR. MELIUS: I just procedurally -- it's a 

little frustrating for everybody here and I think 

what we need to do is to talk about what we did 

before is let's identify a clear list. Let's go 

back and look at the comments the committee needs to 

and see if there are other issues, and then let's 

get information to NIOSH before the next meeting to 

prepare presentations on these and that's fair to 

your staff and I think will be fair to everybody 

involved. 

 DR. ZIEMER: I have identified, from what 

was said, DDREF, RBE, age at -- well, age at 

exposure's not in transition right now, is it? 

That's not -- oh, maybe -- 

 MR. GRIFFON: Because there were some 

comments, public comments and expert comments on 

that issue I'd like to see. 

 DR. ZIEMER: Oh, okay. 

 MR. GRIFFON: Hear how it was resolved. 

 DR. ZIEMER: Were there some other items? 

Mark? 

 MR. GRIFFON: Yeah. Having heard what Jim 

said, and I agree, I would like to reflect on this 

more, but I at least think that I want some 

discussion about the transparency of the IREP model 
158 in terms of the public. It's on the internet and in 

my view, that's about the only thing that's more 

transparent than the epi tables. The problem with 

this whole Monte Carlo approach is that, from the 

public and actually many health physicists, quite 

frankly, you plop a few numbers in and you get a 

result out, and what happens in the middle is a 

mystery. And I think that -- I think we need to 

address that because I think, from the claimant's 

standpoint, it is going to be like Monte Carlo. If 

they put that number in, roll the dice and then come 

out with a winning score, they're going to be happy. 

 On the other hand, when they come out with a 

rejection letter, they're going to want to know -- 

oh, sure -- you know, how exactly was this 

calculated. And I think we -- so that's one topic 

is transparency of that model. 

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 And the second thing is just the whole 

uncertainty analysis, how the Monte Carlo 

uncertainty analysis works. I think there's some 

assumptions that I want to understand better of if 

variables are not independent and you start 

combining variables, you get a whole -- to get your 

uncertainty in your entire final results, you know, 

that has to be assessed certainly, and I'm -- it's 

probably been considered, but I would like to have 

some sort of discussion or presentation from the 
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 159 experts on how that was done. 

 DR. MELIUS: One additional exhibit actually 

Dr. Land brought up this morning was this -- the 

rarer cancers and this grouping issue and how one 

does calculations based on those, how one does the 

grouping and -- he got a little -- confused us, at 

least me, a little bit more in terms of trying to 

understand that issue, so I think it would be 

helpful to have -- that was, yeah, Genevieve's 

question. 

 DR. ZIEMER: Okay. Any others? And you've 

gotten the list there, I think. Okay. 

 Now my understanding that the request is 

also for copies of the comments from the technical 

reviewers for our information, and that will be 

forthcoming. 

 DR. MELIUS: I don't know, just -- I mean 

someone just could notify us when things go up. I 

think -- maybe not every item, but access to it. I 

think I could download it, just -- you know, I fail 

to check every day -- 

 DR. ZIEMER: Just a note, the following are 

now on the web site? Yeah. Yeah, I think -- 

they're going to try to do that. 

 DR. MELIUS: Just say that you've added six 

comments, or not even -- also these other comments, 

we don't know when you sent them out so I don't know 
160 when the set is complete up there. You may have the 

set up there, the comments. I don't know if you're 

still waiting for some or where they stand, so it's 

a little hard to understand when is the most 

efficient time to go in and take a look. 

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 DR. ZIEMER: Okay. Mark, you have another 

comment? 

 MR. GRIFFON: Just one last question or 

request. I think I've asked this before, but the 

on-line version of IREP, I wondered if, as you 

release this in its final form here for use, whether 

this can be provided to the committee in disk form 

-- okay, that's one no. 

 The second question I have is can a model 

detail be added to the on-line version as they are 

not as complete as version 2.1 was. There's certain 

model details that are not -- you've added some 

stuff, but there's some critical stuff that has been 

deleted from -- I have a disk version of an earlier 

version, 2.1, where there's a lot more model details 

in there to look at, including the raw data, the ERR 

per Sievert data, by cancer type. And I think -- 

 DR. ZIEMER: Do we know today whether 

that's -- 

 DR. SCHUBAUER-BERIGAN: I'll just comment on 

that briefly. This is Mary Schubauer-Berigan again. 

 The version that's currently on the web does have 
161 some of the model details, but it stops at the point 

where you're trying to look at the ERR per Sievert 

coefficients. We're working with NCI -- since they 

derived the vast majority of those, we're working 

with NCI to get their permission to put them up on 

the web site, and until their version is actually 

finalized, which -- did Dr. Land mention when that 

was occurring this morning? If he did not, then we 

have no idea when that will be, but our intention is 

to make that documentation at least as transparent 

as the version that you refer to as 2.1. They put 

that version together because that was the version 

that was reviewed by the National Research Council, 

so that was the sort of final draft, and they're not 

at the point where they have the final final. 

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 DR. ZIEMER: Okay. Any other comments on 

this issue? Okay, Sally? 

 MS. GADOLA: I have the feeling from a 

couple of the presentations that there were 

questions that the experts themselves had that were 

working on the IREP and that the National Cancer 

Institute had some questions, and I was hoping 

sometime in the future that we could have a 

discussion of that and what they would like to see 

change, what they would like better understood, 

because they seem like they were on the brink of 

saying something and all the evidence wasn't there 
1 so it was like we will go with this. But I would 

like -- 

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 DR. ZIEMER: Let me -- 

 MS. GADOLA: -- to pick their brain a little 

bit. 

 DR. ZIEMER: I'm going to partially answer, 

unless Dr. Land is still here, but I don't think 

we're ever going to be at an end point where we say 

we know the answers. These things are always what's 

the best information you have right now, and it's 

going to change and it's going to change -- we'll 

keep getting more and better information, but I 

don't think any of the folks at NCI or NIOSH or any 

of the other agencies or even the scientists are 

going to say we now know everything we need to know 

on any of these things. 

 MS. GADOLA: Well, I don't -- no, I don't 

expect an end point. My question is more like what 

else do they think we should be looking at, that you 

don't have all the details but because they are the 

experts, so often you will hear them say well, I 

wish I had a little bit more here or I wish I could 

say this a lot more clearly, but it isn't quite all 

together. But then they can give you a hint, and 

because we also come from a variety of backgrounds, 

we also often can identify people that have special 

interests. And even though things are supposed to 
be scientifically accurate, they're not always 

there. There's a little bit of prejudice. Not 

people wanting to be prejudiced, but just from their 

particular viewpoint. And it's also so important to 

share what all the other people have, so as we do 

our job, I think it's our responsibility to learn as 

much as we can, too. And when you're making a list, 

my question would be what else do we need to be 

looking at? I would like to get the input from -- 

since we have this opportunity from experts, what 

else do you think we should be looking at? What can 

we help you do? What can our backgrounds bring to 

you or what questions can we ask? 

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 DR. ZIEMER: Okay. Any others? Now we'll 

expect to have this item on our agenda for next 

time, at least, and see if questions have indeed 

been answered or if they remain, so we'll certainly 

come back to this as a follow-up next time. 

 Okay, we still have some additional things 

on this topic, so Russ Henshaw is on the agenda 

next. Russ, please. 

 MR. HENSHAW: I have the infinitely easier 

task of showing the Board and those here the 

improvements that have been made thus far to the 

user interface for the software, and there shouldn't 

be anything controversial about that part of it, 

so... 
 1 By the way, if I might just digress for a 

moment, I was the most delighted person in the room 

to discover that Mary could make it here today. 

About a year ago at this time, before I joined NIOSH 

-- several months before I had joined NIOSH, for 

example, I might have defined dose reconstruction as 

trying to figure out whether my grandfather took all 

of his medication last week. So I'm kind of a 

newbie here, so... 

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64

 Also I might add, we have a less-thanperfect equipment setup. I'm going to be kind of 

walking back and forth between the microphone and 

manipulating the access to the software over the 

internet, but that's not a bad thing. It'll be a 

welcome relief from my monotonal voice. 

 I have no power point presentation, but if 

you could turn to your briefing book for the Board 

or the handouts if you are here as a member of the 

public, my -- I have a draft user's guide which 

follows Mary's power point presentation and the tab 

-- the NIOSH-IREP tab. I'd ask you to turn to page 

five of the draft user's guide. 

 The guide was developed by our contractor, 

SENES Oak Ridge, Incorporated. And again, this is a 

draft version. I just got back from a couple of 

weeks on the road demonstrating this to Department 

of Labor staff around the country, along with Brian 
165 Thomas from SENES Oak Ridge and also Jeff Coach from 

the Department of Labor, who I believe is here 

today. 

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 So to access the software, just a brief 

refresher, we go to the NIOSH/OCAS web page. We 

click on probability of causation. One difference 

already from the last Board meeting is you can see 

that we've added a direct link to the software right 

at the probability of causation page, so I'll click 

on that. It takes us right into the software 

program. You simply click on the begin button to 

start the software. That takes us to page six of 

the draft user's guide. 

 This is -- let me just scroll down here and 

show the -- try to show more of the screen. I think 

you'll see one difference already, this Use Data 

Input File, the Go To Upload Page button, which I've 

just clicked on. Prior to this improvement, the 

Department of Labor staff would have needed to enter 

data in every field of the software. With the 

creation of the input file, the -- we now have an 

Excel spreadsheet that will be sent to DOL with 

every claim, which includes all the information for 

the claim. When DOL uploads the file, it will 

automatically populate every field in the software. 

 Now there are three buttons here. One is 

Return to Inputs on the bottom that just takes us 
back to the last page. There's also a Download 

Template button. If this is clicked on it brings up 

the Excel spreadsheet, which can be saved and 

changed as needed, although, again, the claims 

examiners at the Department of Labor will really not 

need to make any changes to the input file. So 

we'll click on the Upload File button. 

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 166

 Brings us to the Upload Saved File screen. 

We click on Browse. Now in this case I have a 

couple of example or sample claims, so for our 

purposes I'll click on Presentations and navigate to 

the Input Files folder. We'll just bring in what 

we're calling here example 1-A. Now when DOL -- 

when a claims examiner at the Department of Labor 

actually operates the software, he'll bring in the 

file from whatever format we're sending it to them. 

 It could be a floppy disk or a CD-ROM or by e-mail 

encrypted. I don't think that decision has been 

made yet. Is that correct, Jim? It's possible that 

the first few claims may come with input files. 

That could change later to maybe an encrypted 

electronic format. 

 So we've brought in the file we need. I 

might also mention that the files will probably be 

named by the claimant's Social Security number. In 

this case it's just example 1-A. So I click on 

Upload File. It's kind of a reassurance message 
there SENES worked into the software for DOL 

purposes. We click on Continue. And now we have 

populated every field in the software with the 

claimant information from this specific input file. 

 And we've made another change in the software. 

This button is now called Generate Results, just 

trying to keep it simple. So we click on the 

Generate Results button and this is what produces 

the probability of causation. 

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 167

 I might add for our sample file we're only 

using 500 iterations. The Department of Labor is 

required to use 2,000 iterations. However, for the 

training purposes, with ten or more computers 

practicing simultaneously, we cut the number down to 

500 to speed up the process. 

 This is the Results Output file. It 

contains an abstract of all the information on the 

original Excel spreadsheet input file. We scroll 

down and here is the result. This claim would be 

compensable, 55 percent. 

 Now this is example 1-A. We have an example 

2-B -- excuse me, example 1-B. The only difference, 

the input data is age at exposure. Example 1-A 

exposure age was 20, example 1-B is 40. I can put 

that one in and run it just to do another example, 

if you'd like. 

 This is really all that needs to be done to 
168 run a claim when the claim arrives at the Department 

of Labor. 

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 Now let me go back for a minute. You might 

recall that there's a special case involving 

multiple primary cancers which requires plugging in 

the results of separate software runs, one for each 

multiple cancer, into a mathematical equation. 

SENES Oak Ridge is currently at work on developing a 

button that will probably move this stuff over, 

maybe move the -- a button here that'll just say 

something like Calculation for Multiple Primary 

Cancers or something like that. That will -- once 

that's accomplished that will allow the Department 

of Labor claims examiner to punch in each 

probability of causation percentage into a table and 

the software will then run that equation 

automatically. 

 There's another example that -- another 

situation that could require multiple software runs, 

and I'll show you that by clicking on the Advanced 

Features button. This is a case where the 

probability of causation result is at least 45 

percent but less than 50 percent. As you probably 

recall, the Department of Labor claims examiner in 

that scenario would be required to up the number of 

iterations and run the claim again. 

 Now initially we pondered whether to 
16 distribute random number tables or how to get them 

accomplished that easily, but we finally decided it 

would be best to automate that function. Just 

actually within the last week SENES has added this 

Generate New Random Seed button, so all they'll need 

to do is click on that. It generates a random 

number between one and one million. Excuse me, I 

said earlier that the sample files used 500 

iterations. It was 200. As you might recall, that 

scenario of probability of causation between 45 and 

50, DOL is required to up the number of iterations 

from 2,000 to 10,000, so all they need to do in that 

event is click on that button, generate the new 

random seed and change their random sample size, and 

then submit the data and run it again. 

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 I won't do that now because it does take 

quite a while. I'm sure the Board has better things 

to do than sit here and watch that time clock on the 

screen -- but that's essentially it. We think we've 

made it as user-friendly as possible, and the 

Department of Labor staff seemed to be very pleased 

with the improvements to the user interface that 

have been made. Really this has all been done in 

the last month. 

 So I can take questions or run another 

example or whatever you'd like. 

 DR. ZIEMER: In this newest version you 
don't have to put in information about the 

distributions? It's just carrying the defaults 

unless you specify otherwise or... 

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 MR. HENSHAW: That's correct, sir. The 

input file will contain all the information needed 

to run the claim. 

 DR. NETON: Russ, maybe it would help if you 

could show that -- 

 DR. ZIEMER: Oh, so that's dumping it in 

automatically from the spreadsheet then. 

 MR. HENSHAW: Yes, sir. 

 DR. ZIEMER: Ah, gotcha. 

 MR. HENSHAW: Show the input file, Jim? 

 DR. NETON: Yeah, show that spreadsheet that 

you actually downloaded. 

 DR. ZIEMER: Before we did the enter doses 

business, as an example, manually. But here you 

would have the sheet downloaded that has all the 

doses and the distributions? 

 MR. HENSHAW: Yes, sir. Everything, 

including all the claimant personal information from 

gender to age at diagnosis, age at exposure. Really 

every single piece of information needed to run the 

claim. 

 This is again the Download Template button. 

 We'll just open the file. Now the file can be 

saved and manipulated if needed, but again, the 
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 171 claims examiners will not need to do that. 

 DR. DEHART: Is this in beta test now? 

 MR. HENSHAW: Claims have not yet been 

submitted to the Department of Labor. The intention 

-- we believe that this is working correctly, so 

this -- unless something comes to the surface, some 

problem with it, this will be what will be sent. 

 Just to show you a couple of things here, 

for example, let's just look at the top row. If we 

go to NIOSH district office, the field has a pulldown menu. We'd type in one of the four district 

offices, and that's a similar -- similarly for each 

of the fields, and I think that one you type in, but 

for exposure rate, again, the two choices, acute or 

chronic. Similarly for radiation type and the 

distributions. 

 Now most cases the distributions are going 

to be normal or lognormal or perhaps constant, so 

they have -- the other ones, as I understand it, 

will not come into play that often, but of course 

they're there as options in the pull-down menu. 

 MR. GRIFFON: An explanation -- number of 

exposures up there, is that one? 

 MR. HENSHAW: Uh-huh. 

 MR. GRIFFON: And you have a series of 

exposures here? Am I misinterpreting that? 

 MR. HENSHAW: That's a mistake. 
 MR. GRIFFON: 172 'Cause you're only looking at 

the first one that way. Right? 

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 MR. HENSHAW: Right. Yes, that's correct. 

I think in this -- I think if one is in there -- let 

me just check something. I think for this example I 

think the function of one in that field means that 

we're only pulling one into the example scenario for 

ease of training purposes. But if we change that -- 

I forget how many we're on here. I think it was 

over 100, but if we change that to the correct 

number, it would take that much longer to run in the 

training, so... But for -- let me just get out of 

this, unless there are any more questions about the 

input file? 

 MR. PRESLEY: What do you do about chronic? 

 MR. HENSHAW: I'm sorry? 

 MR. PRESLEY: Chronic exposure? Just mark 

it? 

 MR. HENSHAW: Right. 

 MR. PRESLEY: Okay. 

 MR. HENSHAW: As I understand it -- Jim can 

correct me -- but most likely that will more often 

be acute because we default to acute if the exposure 

rate is unknown. Just minimize that for the time 

being. 

 DR. ANDERSON: This will also be on the web 

page then for the -- 
 MR. HENSHAW: 173 That's what I'm running off of 

now. 

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 DR. ANDERSON: -- claimant? 

 MR. HENSHAW: Right. Sure. 

 DR. ANDERSON: Will they get any Excel -- 

going to be concern that the claimant's going to try 

to potentially run this thing and get a different -- 

a different result. 

 MR. HENSHAW: Right, we've -- 

 DR. ANDERSON: You could give them the data 

file. They can run it to believe it and they'll get 

the same result. 

 MR. HENSHAW: I'm going to defer that 

question to Jim. I'm not sure what the intention 

is. Are we sending the input file directly -- the 

input file itself directly to the claimant, Jim? 

 DR. NETON: No, we didn't intend -- we're 

not intending to do that. We are sending them an 

exact copy of that spreadsheet, though, as part of 

their dose reconstruction report, so they could, if 

they wished to, enter the data themselves to 

determine if the Department of Labor's ultimate 

calculation was correct. 

 MR. HENSHAW: One other thing I just might 

show you. Again, all these -- all the changes were 

made with the Department of Labor claims examiners' 

staff in mind. Just generate results again. 
 

 Once the claim examiner has reached this 

stage, which is really it -- basically it's pushing 

a button, they then can save the file, and we're 

advising them to -- there are three choices. We 

can't control this; this is a Windows function. But 

I don't think Bill Gates would like us to get in 

there and change the Windows programming, but we're 

advising them to save it as a HTML-only file. Once 

they do that, if there was ever a need to open up 

the claim file again, it will appear exactly as it 

did in the first claim run, preserving the 

formatting and so forth. 

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174

 MR. GRIFFON: I was just wondering, and I 

think -- I don't think you guys have gotten to this 

yet, but have you put together any sets of examples? 

 I'm looking at something from Charles Land where 

he, in their publication, compared the IREP model to 

the old NIH 1985 epi tables and the outcomes at 

various ages for various types of cancer, he 

systematically did a table on this and I wondered if 

-- I know you've done different examples and 

scenarios. Have you put together any sort of 

systematic comparison of this IREP versus the 

previous -- and part of the reason I'm asking this 

is because I think we -- I've heard several times on 

this committee that when in doubt, we're trying to 

use the claimant-friendly -- or erring toward the 
175 side of being friendly to the claimant. But without 

some knowledge of these numbers and comparing past 

numbers, I don't think we can really evaluate that 

as a committee, so I'd be interested in whether 

you've done that. 

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 DR. ZIEMER: One thing we heard this morning 

was that, for example, if ICRP-60 model gives a 

lower probability of causation than the old model, 

they're not going to go back to the old model just 

for that purpose. In other words, they will 

consistently use the same models. So I don't think 

it's always making an assumption in favor of -- just 

for the claimant's sake by saying well, in this case 

we'll use a different model 'cause it helps the 

claimant. That was my understanding. So in this 

case, what is it that you default to in the absence 

of other information? I mean you're going to -- 

you're only going to default to those values and 

distributions where you don't have information to 

the contrary. Right? If you have information that 

says that the dose distribution was not lognormal -- 

 MR. HENSHAW: Right, yes, the -- 

 DR. ZIEMER: -- if there's actual data to 

support that -- 

 MR. HENSHAW: Yes. 

 DR. ZIEMER: -- then you would go with the 

real data. Right? 
 MR. HENSHAW: 176 Exactly. The health physicist 

will use a fitness of fit test and they'll pick the 

distribution that is the best fit to the data. Just 

that practically speaking it's most often going to 

be normal, lognormal or otherwise constant. 

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 DR. NETON: One of the important differences 

between the IREP program and the interactive 

radioepi tables, as I understand it, is this program 

allows for the input of uncertainty distributions 

about the dose and as a function of various 

different energy radiation types. I think the way 

the tables do it, I believe that they select the 

95th percentile and use that in the table to 

determine what the probability of causation, so I 

think it would be somewhat difficult -- you have to 

look at the whole picture and it would be difficult 

to compare based on a number of differences. Also 

in addition to what Dr. Ziemer pointed out, the 

differences in the dosimetry models themselves. So 

I guess it would be hard to make a direct comparison 

and the answer is we have not done that. 

 MR. GRIFFON: I know it's difficult. I 

might refer you to table E-4, though, in Charles 

Land -- I mean he did make an attempt. I mean he 

did make a distinction that there are some -- it has 

a lot of footnotes in it on why -- why it's hard to 

compare, but yeah. 
 DR. SCHUBAUER-BERIGAN: Yes, the 

recommendation of the NAS review panel, they did 

expand that comparison in their draft final report, 

so you should be seeing more of that. Given that 

presentation, we didn't feel the need to do the same 

since our -- the basis of our program is NCI-IREP. 

But I want to be clear that if the science provides 

information that is defensible and differs from the 

1985 tables, the approach was to incorporate it. So 

you can't say that in every case distributions were 

shifted to favor the claimant. That certainly is 

not -- I would never say that that occurred in the 

development of NCI-IREP. 

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177

 DR. ZIEMER: Okay. Further questions or 

comments? 

 We're due for our break here and let's take 

the break for 15 minutes, reconvene at 3:25. 

 (Whereupon, a recess was taken from 3:10 to 

3:25 p.m.) 

 DR. ZIEMER: Russ Henshaw has a few 

additional comments he wants to share with us, so 

let me give Russ the floor again, please. Where'd 

he go? There he is. 

 MR. HENSHAW: Thank you. Actually I have 

four, based on some questions and comments I got 

during the break. I want to point out that there is 

a typo in one of the examples, and that's on page 17 
17 of the user's guide. It's example number 2-A. If 

you'll look to the line that says dose, it says ten 

centisieverts. That should be 50 centisieverts. 

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 It's particularly important -- it's an 

unfortunate typo but it's particularly important 

because in our training the whole purpose of 

examples 2-A and 2-B were to show the difference 

between a non-smoker -- the effect of non-smoking or 

a smoker in the probability of causation results, so 

everything in those two examples, all the input 

should be identical except for the never smoked 

versus smoker. So you can make that 50 

centisieverts instead of ten. 

 Also just to clarify, if anyone wants to do 

that, you can still go into the software and enter 

data by hand. You need not use the template. You 

can also download the template, if it's simpler to 

do it that way, and change information on the 

template, save the file, and then upload the 

modified file. 

 And let's see, what else was there? Yeah, 

one final -- oh, two final things. I just want to 

direct your attention to a glossary on pages 11 

through 15, which is in draft form. We're still 

adding terms to that and we have a number of terms 

to add just based on the feedback from our training 

sessions. 
 17 And finally, just a further clarification, 

the scenarios that require more than one software 

run -- that would be, for example, unknown primary 

cancer where the claim examiner has a secondary 

cancer, then you go to a table and it leads you to a 

number of plausible primary sites -- the Department 

of Labor will receive a separate input file for each 

run and they'll be marked something like file name 

with a small a, you know, and then a small b and a 

small c and so forth. Thanks. 

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9

 DR. ZIEMER: I'm going to suggest, too, on 

your user's guide that you make sure as you go 

through that to use the SI system of units 

correctly, which -- and Gen Roessler will correct me 

if I'm wrong here, but if you have a unit named 

after a person, such as a Sievert, believe it or 

not, it is not capitalized when used in a sentence, 

but it is capitalized when abbreviated. So a volt 

is a little v-o-l-t, but an meV is a m-e capital V. 

 So in here where you have -- well, for example, on 

the definition of a rad where it says one Gray, 

technically the Gray would be lower case, not upper 

case and so on. I assume the agency follows the SI 

system and ICRU system for those. I get a little 

picky on that 'cause I'm always picking on my 

students. 

 MR. HENSHAW: I'll make sure that those 
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 180 changes are made. 

 DR. ZIEMER: Just go through the thing and 

make sure it's consistent with -- 

 MR. HENSHAW: Right. 

 DR. ZIEMER: Thank you. 

 MR. HENSHAW: Thank you. 

 DR. ZIEMER: Now I want us to look at a 

couple of possible things here before us, realizing 

that there is the change in the agenda that we've 

already described. One thing I think would be 

useful if we did first and that is to go back and 

revisit very briefly the idea of future topics and 

items. This came up when we looked at the minutes 

and we talked about tracking those items, and if we 

can use that as a starting point -- which minutes -- 

those were the February 14th minutes, I believe. 

Could we use that as a starting point, see where we 

are on the items that were on that list and maybe 

you can just -- page 18 and tell us where we are. 

And then it would be helpful I think even right now 

if we could identify additional items and ask that 

for future meetings, future agenda items that people 

specifically want to make sure do not fall through 

the cracks. So could we then -- yeah. 

 MR. ELLIOTT: Okay. On the February 14th 

minutes, on page 18 you'll find a bulleted -- 

bulletized list of suggestions for future meetings. 
181 And just so you have an understanding here of what 

we're going to attempt to do, we -- I've asked Marie 

Murray, our writer/editor, to capture for us, as you 

speak about things you'd like to see addressed, 

issues you'd like to see presented on, and I'm sure 

she's got many of those that we just talked about 

about the IREP, about the RBE's and DDREF. We're 

going to have that on a separate table where we can 

show you what's -- what action has been completed on 

them, what's pending, what things have been 

conducted fully. 

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 In that regard, this first bullet, 

information that could be addressed by experts other 

than NIOSH staff, such as topics mentioned the 

previous day in connection with DOE records found to 

be deficient, I don't believe we have done anything 

in that regard for you, and I would appreciate any 

suggestions you might have about who those experts 

might be or what specific topics you would like for 

us to have covered for you. 

 The second bullet, a legislative background 

history, particularly as it relates to the SEC. And 

tomorrow I think you'll have that addressed for you 

by Dr. David Michaels, who'll talk more than just 

about the SEC, but the whole history of this 

legislation as it was passed. 

 So the third bullet there, background on 
182 IREP model, issues discussed at the first meeting, I 

would like to think that we addressed some of that 

today with Dr. Land coming in to share with you 

where NCI's at on their revision to the IREP, and we 

certainly have I think heard you loud and clear and 

have a list that has been created this afternoon 

with regard to IREP, and we'll share that list with 

you in the table, as I mentioned. 

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 The fourth bullet, comment on the statute's 

language describing the Advisory Board's review 

procedure, which is felt to be -- by some to be 

misleading, if not inaccurate, and require Board 

comments. I guess I -- I've looked in the statute 

and I've looked in the Executive Order and I would 

appreciate your help on identifying what your 

particular concern in this regard is. I don't know 

who offered this. I could go back to the transcript 

and find that, but I would ask you to assist us on 

that comment to narrow it down or determine exactly 

what it is you'd like to explore there. 

 I think that covers it. 

 DR. ZIEMER: Thank you. If someone can help 

clarify that fourth bullet, that would be helpful, 

and then are there other items that -- in addition 

to those we have already discussed today that you'd 

like to put on this sort of master list now that 

will be generated as the staff looks forward? And 
183 if you don't think of them today, we can have input 

later. 

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 Jim? 

 DR. MELIUS: Yeah, I think one other issue 

and it's this -- I think deferred partly because of 

these Special Exposure Cohort guidelines, but 

there's the issue of when NIOSH returns a claim -- 

what are the criteria for NIOSH making a 

determination that there's not sufficient exposure 

information in order to make a determination and how 

will that be -- you know, what will those criteria 

be? And I think they feed off Special Exposure 

Cohort guidelines, but I think they -- also 

independent of those, to some extent and I think 

they should be -- I would like a presentation 

discussion on those. 

 DR. ZIEMER: Do you see that as sort of 

being part of the dose reconstruction process where 

the data appear to be inadequate and what do they do 

then? Is that... 

 DR. MELIUS: Yeah, how do they make that 

determination? There's some procedural -- 

 DR. ZIEMER: That there is an inadequate -- 

 DR. MELIUS: Yeah, inadequate thing. As I 

say, it's one of the criteria for the Special 

Exposure Cohort, so -- but they're going to be 

making it on an individual basis also and those 
18 might not necessarily have the same criteria. And 

it's also I think a question of what records are 

missing or unavailable or can't be found and then 

how far do you go to try to get those records and -- 

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 DR. ZIEMER: So it's part of the bigger dose 

reconstruction picture then, yes. Okay. I'm trying 

to sort of categorize these in my mind, so that's a 

piece of dose reconstruction, and others. 

 DR. MELIUS: Another piece of that which I 

mentioned earlier is the -- how is this committee 

going to review the dose reconstructions and what 

procedures will we have for that. 

 DR. ZIEMER: And that's a whole topic that 

we're going to have on the agenda, in fact -- well, 

that's a whole topic, yes. Right, thank you. 

 DR. MELIUS: And then I think an -- well, 

related to dose reconstruction is that if there's a 

contract let for that, what is going to be the -- 

how is conflict of interest issues going to be 

addressed. I think -- I think we had talked about 

it both in terms of the Board but also in terms of 

outside groups doing the -- under contract doing the 

review. There's issues that it's a relatively small 

professional community and that there have to be 

some guidelines, both for us, but I think also for 

the -- especially for this outside contractor and 

how that would be doing. I think we would -- I 
185 think that's very critical to the credibility of the 

process and how people -- claimants will view it and 

so I think that's something that's worthy of a full 

discussion by the Board. 

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 MR. ELLIOTT: Could I focus in on what 

you're asking for? Would it be something of the 

order of what is the quality -- the conflict of 

interest plan that is in place with regard to the 

contractor? Or what is it you really want to hear 

that -- 

 DR. MELIUS: Yeah, I may not be being clear. 

 One -- number one is the conflict of interest plan 

for the contractor and what that would be -- what 

that should be. It never fails that a cell phone 

goes off when you're talking. And secondly would be 

the -- so what will you have in place for the 

contractor? I think we really need to -- I guess we 

-- I'm sure we can say we can review that, but we 

need to -- I think we should be commenting on that 

and have that presented to us when you presumably 

reach some agreement with the contractor. 

 MR. ELLIOTT: At the risk of sounding like 

I'm managing the Board again, this is a procurement 

issue and the contract that is awarded will have in 

it a conflict of interest plan that has been 

negotiated and agreed upon between the Agency, the 

procurement office of that -- of our Agency and the 
18 proposer. And I want to be very clear. I'm going 

to be honest with you and straightforward when and 

where I can be, you're not going to have an 

opportunity to provide advice on the content of 

that. You'll have opportunity to evaluate it, 

examine it and make, you know, whatever thoughts you 

have about it known and any recommendations, but 

that's going to be in place upon the award of that 

contract. And I have no -- we have no ability to 

bring you into play into that process. 

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 DR. MELIUS: I think -- 

 DR. ZIEMER: Let me interject here, Jim. I 

think what -- if I understand it correctly, though, 

you're saying it would be helpful for the Board to 

know what that conflict of interest plan is for the 

group that gets the award. They have to submit a 

conflict of interest plan as part of their proposal, 

as I understand it, and although it's a procurement 

issue, I think the Board is asking to be made aware 

of the details of that. 

 DR. MELIUS: Yeah, I just would -- I under 

-- you -- NIOSH has made a decision not to discuss 

that with us prior to awarding the contract, and 

there were -- you could have done it at an early 

meeting prior to the RFA going out and could have 

asked for input but you decided not to do that. So 

we realize we're reviewing after the fact, but I 
think it's -- at least personally I think it's a 

very critical issue and it's going to be key to the 

credibility of this overall process. And if you put 

in place a deficient plan, I think it's our job to 

tell you that. Now you can then have to work within 

procurement guidelines, et cetera, to figure out 

what to do or whether or not to take our advice, but 

that's understood. 

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 187

 I think separate from that there's an issue 

how does this Board review that dose 

reconstructions? I think we have to be cognizant of 

potential conflicts of the Board, and I think that's 

a simpler process in terms of that review and in 

terms of how we do it, but it ought to be something 

we discuss there, also. 

 MR. ELLIOTT: I don't want to be 

misunderstood. I'm not saying you cannot see that. 

 I'm just saying you're going to see it and you're 

going to have the opportunity to evaluate it, 

examine it, but it's going to be put in place. And 

then whatever comments you have about it, whatever 

recommendations you wish to make about it, if we can 

make change and we think it's appropriate to make 

change, we will. But I can't bring you into the -- 

to the process in advance of that. 

 DR. ZIEMER: Okay. Additional items for 

this master list? Okay, Robert and then Henry. 
 MR. PRESLEY: 18 Would it be possible to have 

one of the legal -- the lawyers give us a overview 

of what we can say and what we can't say to 

claimants? I don't know how many people are getting 

calls, but I am, and if I'm the only one, then I'll 

be more than happy to talk to them one on one, but 

it might be a thing to have somebody come and talk 

to us about what can and cannot be discussed. 

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 DR. ZIEMER: We're all thinking of just 

telling them to call Robert Presley. 

 MR. PRESLEY: Somebody's already done that. 

 DR. ZIEMER: Okay, so noted. Henry? 

 DR. ANDERSON: (Inaudible) 

 DR. ZIEMER: Okay, Roy? 

 DR. DEHART: It's perhaps a bit early, but I 

would like to get on the list the concept of -- at 

some point in time there is going to be publication 

of the process, as well as the results in terms of 

the numbers of cancers identified and so forth. And 

I think it would be helpful to see or begin to 

discuss what the plans are to assist that 

publication process. 

 MR. ELLIOTT: Let me make sure I understand. 

 I'm trying to make sure I capture exactly what you 

want. Would you be talking about the statistics 

that we put forward about how many claims come 

through, how many lung cancer cases were examined, 
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 189 how many awards were made, those kind of things? 

 MR. PRESLEY: Let me ask a quick question on 

that while we're on that -- 

 DR. ZIEMER: Use your -- 

 UNIDENTIFIED: Would you turn your 

microphone on? Thank you. 

 MR. PRESLEY: Could we do that also by site? 

 Would that be -- or geo-- by area? 

 DR. ANDERSON: Actually my first issue was 

somewhere along that line. I think I would like to 

hear what NIOSH's kind of tracking plan is going to 

be. We've seen the slides of total numbers received 

by DOL and that, I think that's useful. But I think 

we may also want to look at some of the -- if 

there's additional plans which would be the type of 

cancers and kind of come up with what should be your 

kind of template for a updating report, how often 

are you going to generate your statistics, how often 

will that be then put up on the web if it's going to 

be on the web. 

 And then the other would be to look at are 

there some kind of quality control issues that you'd 

thought about that you're going to implement. One 

of those would be the -- do we want to track the 

number of days between when something is received, a 

letter goes out, how long it takes for final 

adjudication. I mean we're early on now so there's 
plenty of time, but I think before you get into 

everybody asking you about what about that number, 

you're going to be chasing some statistic and it 

would be better to have a plan in place and why 

we're doing that. And then what would be the goal 

-- you know, like one project we've been on with the 

hospital, tracking how long does it take for a 

physician to get their report in and things like 

that. You can -- if there seems to be a number 

that's out of line, you can then work either with 

the contractor to improve that. 

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 The other one later on -- I think we've got 

more than enough on our plate, but I would really 

like to hear, based upon your -- the dose 

reconstruction and the other IREP types of 

processes, where do you see the most significant 

gaps, kind of what's on the horizon for research. 

Is there anything we could help you with to support 

-- 

 DR. ZIEMER: Problem issues, huh? 

 DR. ANDERSON: Yeah, on our behalf here are 

the critical issues that we need more data on. Are 

there studies underway that will come out in two 

years, those kind of issues. 

 DR. ZIEMER: That relates a little bit to 

what Sally was talking about, too, some of the 

critical issues that need to be addressed. 
 MR. ELLIOTT: So I have performance and 

quality control measures and I have what research 

questions or information gaps need to be addressed. 

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191

 DR. ANDERSON: Yeah. 

 MR. ELLIOTT: Okay? 

 DR. ANDERSON: Yeah. 

 DR. ZIEMER: Jim? 

 DR. MELIUS: Yeah. This may be a related 

issue, but it goes to access to information from the 

Department of Energy facilities. You have a -- the 

MOU I guess is taking a while to finalize and either 

I guess I'd like to hear sort of a presentation when 

it's finalized -- what assurances are we providing 

to the applicants that a complete search has been 

done for information relevant to their particular 

case. I think that's, again, a real important 

credibility issue for the program. And absent an 

MOU, I think at our next meeting I'd like at least 

an update on what the -- where are you getting 

information and are there problems that you're 

perceiving with types of information that's more 

difficult. And I think there is going to be at some 

point sort of a balancing. How far do you go to try 

to get information that someone thinks is available 

or may be available and versus what's practical. I 

know you're wrestling with that on a day-to-day 

basis, but I think it would be helpful to have some 
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 192 discussion of that, also. 

 DR. ZIEMER: Thank you. These are a good 

list of things to address. Got another one? Okay. 

 MR. GRIFFON: Just to follow up on that 

point, I think it would be useful to understand the 

records request process. In an earlier meeting I 

was sort of under the impression that the 

subcontractor doing the dose reconstruction would 

have direct access to records on the sites, and 

recently I've been convinced that that may not be 

the case, so just a description of how the records 

requests -- what kinds of records can be -- are 

being request -- are relevant, and then how the 

process works, DOE to NIOSH to subcontractor or how 

that works. 

 DR. ZIEMER: I'm going to interrupt this 

discussion. We can come back to it, but I have 

become aware that as the storm has gathered, we're 

losing some of our folks in the general public. And 

although no one had signed up for public comment, I 

do want to give one more opportunity. If there are 

members of the public who have comments, I don't 

want to preclude that, and let's do that now before 

everybody takes off and tries to beat the storm home 

or whatever. Are there -- is there anyone left that 

has public comment? 

 Okay, we have at least one, even though not 
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 193 signed up, but you have no competition. 

 MR. MILLER: I assure you I'll limit my 

comments to less than five minutes so that others 

will have an opportunity as well. I'm -- 

 DR. ZIEMER: You need to -- 

 MR. MILLER: -- Richard Miller -- 

 DR. ZIEMER: -- identify yourself, Richard, 

for the -- 

 MR. MILLER: -- thank you, Mr. Elliott. I 

don't know if this is the right time to ask for this 

since the rule has now been published, and maybe I 

can stand being corrected as well. But at least in 

reviewing the web site up to this point for OCAS, I 

wasn't aware of the inter-- what's called the HHS 

family, interagency communications that dealt with 

comments on this rule. It's pretty plain from 

reading the -- it would seem -- it seemed to me at 

least plain from reading the preamble to the rule on 

the probability of causation that NCI played a 

disproportionate role in answering and addressing 

questions that either the public or your invited 

experts had raised. One particular example comes to 

mind from the preamble, which I don't have in front 

of me, but spoke to the question of what do you do 

about the age at exposure debate. And in there it 

said well, if this is going to be changed, we really 

would have to change it through NCI and this would 
194 also involve how the program affecting -- I think it 

was the atomic veterans program, I think it was, 

would also have to be modified because the -- NCI's 

model would be applying to both that program as well 

as to this program, the energy employees 

compensation program. And so that would require an 

interagency and other committees deliberating. And 

so it was clear that what was happening was this was 

not a NIOSH rule and that any changes to it are 

going to have to involve interconnections with other 

programs and other agencies, or other arms of CDC, 

let's put it that way, or other arms of HHS. So I 

guess I would find it helpful, if it exists and if 

it's disclosable, to see the intra-agency 

communications between NCI and other agencies -- and 

I don't know who the others are that are involved. 

I heard Mr. Neton mention that there were other 

agencies and I don't know who they all are, but it 

would be very helpful to see that communications 

laid out, maybe posted on the web page may be the 

fastest way for us to get it, but it would help to 

have a little bit more transparency to understand 

what NCI communicated to NIOSH and vice versa, what 

NIOSH communicated to NCI, so we can see how we got 

this result in front of us today. That's sort of my 

comment and request. 

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 MR. KATZ: Hi, Ted Katz. Richard, I'm not 
195 entirely sure what the right response is to that in 

terms of what we can share in interagency 

communications, but certainly we'll share whatever 

we can share. 

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 But let me just be clear. I think I'm able 

to say this, that the agencies we receive comments 

from and responded to comments from were not NCI, 

actually. They were HHS -- I mean our mother 

Department -- and the Department of Labor and the 

Department of Energy and the Department of Justice 

and the Office of Management and Budget. So in 

fact, NCI wasn't in the loop as a reviewer. Oh, and 

the Defense Threat Reduction Agency. Well, that -- 

right, they had public -- I mean they were part of 

public comments. I mean you can see all the public 

comments -- and a lot of these -- you know, we had 

public comments from the Department of Energy, for 

example, from their field offices and so on. Those 

are all a matter of public record and they're in our 

docket, so you can see those. 

 But in terms of interdepartmental review, 

those are the organizations that were part of the 

interdepartmental review. Those are the folks we 

responded to in making changes to the rule. 

 MR. MILLER: Thank you, Ted. I guess the 

thing that was startling perhaps to me in reading 

the preamble -- I mean I didn't -- maybe it was just 
because I wasn't ready and wasn't prepared and 

didn't expect it -- was to look at specific comments 

that were raised, particularly with respect to the 

probability of causation rule. And rather than what 

it's saying NIOSH's position is -- there's 

insufficient evidence or that there's not a 

sufficient weight of evidence or that there are 

differing studies and we don't have this question 

resolved -- we hear NCI's views are there is 

insufficient evidence, there is insufficient weight. 

 And so there was a confusion on my part -- maybe it 

was a typo, maybe it was my misreading -- but I was 

unprepared for that and I wasn't clear where NCI's 

role begins and ends and where NIOSH's role begins 

and ends and particularly in all of the policy 

decisions about applying this model. 

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 MR. KATZ: I'm sorry, let me hop back up 

here again -- Ted Katz again. There really -- there 

are very few instances in these rules where we 

discuss NCI. And I think what you're thinking of is 

circumstances where, for example, you have an 

element of IREP that applies equally to the 

DOE/EEOICPA population and to the VA -- the VA's DOD 

population, where there's really no scientific 

reason to discriminate between them. Then you do 

what we have said, and I really think -- I believe 

there's just one instance of this, but there we're 
saying if there's no scientific reason to 

distinguish between these populations and how you 

treat them scientifically, because this is one 

department, we do indeed want consensus in how to 

deal with that scientific issue. And so you're 

absolutely correct and there is an instance of this 

-- and I believe it's just one, but I could be 

wrong. But in that case, it's an issue that has no 

distinctions for the DOE population in effect. 

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 MR. MILLER: Well, thank you, Ted. I'm not 

going to debate the distinctions between those that 

were at a single atomic bomb blast at the Nevada 

Test Site and the distinctions between those who had 

long-term exposures working in the weapons 

production program, but I think there are 

significant distinctions in the epidemiology that 

studies them because the nature of the exposures 

were different. You had a single blast at a single 

occasion in many of those that are covered under 

that particular program, and I think there's a 

fairly significant -- there are at least a number 

of, and you did reference them in the Federal 

Register notice, published studies which 

specifically speak on point to this question about, 

for example, age at exposure, the degree and extent 

to which one can adequately explain how it's 

possible that at age 40 somebody is one-third as 
radiosensitive as somebody at age 20 to the 

identical exposure. And that will have a 

significant outcome upon the compensability of 

individuals who are in fact in very different work 

environments with different types of exposures and 

in different environments. And I would just say 

there are different studies that will apply to those 

who were let's say at ground zero as atomic vets in 

the Nevada Test Site at a blast and those who were 

working in an oxide facility handling alpha 

particles and ingesting them with inadequate 

protection. 

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 And leaving that aside, the character of the 

exposures, it seemed to me we ought to deal with the 

population that's in front of us, for what it's 

worth. And if, to the extent and degree that NCI's 

going to play a role in determining what's 

appropriate for this population, then that ought to 

become a good deal more transparent. And I don't 

see that transparency and I guess I would like to -- 

that's why I'm asking for, if there are 

communications, whether they're e-mails, whether 

they're memorandum, recommendations, documents, 

briefing points, whatever it happens to be, it would 

be very helpful to have some transparency and some 

openness so this is out on the record so for those 

of us outside government we can have some window -- 
1 just some kind of insight -- to figure out how we 

got from point A to point B. 

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 I'm not saying anything's wrong here. I'm 

saying we need more transparency because it's very 

confusing from the outside to read the preamble and 

to kind of guess what might have happened. So I'm 

just asking, if you've got those communications, if 

they're available, we'd sure like to know about them 

and we'd like to get them on the record. 

 DR. ZIEMER: Thank you very much. Are there 

any further public comments? There appear to be 

none. 

 Now I have two possible items -- let me see 

how we're doing on time. It's 4:00 o'clock so we 

have some time. Two possible items. One is to ask 

whether anyone wishes to discuss at this time, in 

general terms or just in terms of general views, the 

issue of Special Exposure Cohorts, realizing we do 

not have before us the document that's being 

developed on that issue by NIOSH. But the 

possibility of any particular issues that you want 

to raise now, to ask that they be addressed in 

connection with the presentation next time or 

anything related to Special Exposure Cohort at this 

point. Roy? 

 DR. DEHART: It may be covered tomorrow, and 

if so, certainly we can wait till then. But can 
200 someone provide us a history of how this came about? 

 It'll be tomorrow? Fine. 

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 DR. ZIEMER: We will have the presentation 

by David Michaels tomorrow. David at the time was 

with the Department of Energy and has first-hand 

knowledge of the development of the legislation and 

related issue, and I think we can certainly discuss 

with David the issue of Special Exposure Cohort, at 

least in a general way, not with specific focus on 

the documents being prepared, but -- Jim? 

 DR. MELIUS: I was actually going to suggest 

that we do that as part of David's presentation, and 

if he could start a little earlier or something, if 

he's available, that might make it -- give us time 

to talk about that 'cause I think it will actually 

come out of that legislative history, be a lot 

easier to talk about and I think he can provide some 

background on that. And then I think we can more 

easier -- 

 DR. ZIEMER: We can jump off from there, and 

I agree with that, but I didn't want to preclude, 

since it came up earlier, if people had particular 

items they wanted to put on the table now. But it 

certainly will be more natural tomorrow to do that 

and we'll proceed on that basis. Is that agreeable 

with everyone? 

 Then the final thing that I had jotted down 
201 was to ask whether or not anyone wished to focus on 

any of the specific changes in the rule. We talked 

this morning when we had the general sort of 

discussion on the final versions of the rule and I 

don't know if you've had a chance to look at any of 

those or -- but are there any specific issues that 

people want to -- or do you want to take time now 

and say let's look at those rules and sort of stepby-step and look at the real changes and discuss any 

of them? I'm basically asking how you wish to 

proceed at this point. That was kind of a left-over 

item. I think there was some sense in which folks 

felt that, although we had a general description of 

those changes, it wasn't completely clear what the 

real final version looked like compared to the 

earlier versions. Henry? 

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 DR. ANDERSON: Yeah, I just found it 

difficult to see where the wording was actually 

changed, and what would have helped is a red-line 

strikeout kind of a thing so you could hone in on 

where the -- I mean we could see where the changes 

that we recommended, the one, got put into some of 

them. But for some of the other discussion, it's 

harder to tell whether -- you know, how or how it 

might have been changed or how many words were 

actually changed. I don't have the earlier version 

here with me so I can't try to read the two at a 
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 202 time. 

 DR. ZIEMER: Well, it certainly is clear to 

me that the changes that we recommended are there 

and I have -- 

 DR. ANDERSON: Oh, yeah. 

 DR. ZIEMER: -- identified them, and -- 

 DR. ANDERSON: That was new. I can see 

that. 

 DR. ZIEMER: -- I think perhaps rather than 

go through each change, no matter how great or 

small, the question would be are there particular 

issues that any of you were concerned about that we 

-- that might have been identified as changes and 

want to know exactly what is the change. Are there 

any of those? Or what was it before and after or -- 

 DR. MELIUS: I just think we need time to 

look at it and -- I mean it's very hard to do it in 

abstract and I don't want to preclude a chance to 

discuss it, and I don't -- is there any way we could 

get a red-lined strikeout copy between now and 

tomorrow morning? Is there one sitting in a 

computer someplace? 

 DR. ZIEMER: I'm going to guess that's not 

going to be very easy since there's formatting 

things, but perhaps in the interest of efficiency we 

can -- we could declare just a working session and 

allow you to just spend some time looking at that 
203 now and we can discuss it tomorrow. But you know, I 

leave it up to each of you if you wanted to do that 

here or in your rooms or whatever, but otherwise, as 

far as the agenda is concerned, we would have no 

additional agenda items today beyond that issue. 

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 MR. KATZ: Let me just -- this might help, 

Jim, is as you go through the preamble, in the 

summary of the sections -- I mean at least for 

anything -- I think for all the substantial changes 

that are made, in the summary of the sections in the 

preamble, it will indicate that changes were made to 

that subsection so you don't really -- you don't 

have to -- it shouldn't be that hard for you to 

identify where the changes have been made. 

 DR. MELIUS: You know this in more detail, 

but my -- my recollection is that some of those say 

they're -- that the regulation's been changed but 

doesn't say what the change is, so you have to go 

and look at it and then try to remember what it was 

then before. 

 MR. KATZ: But it actually -- in the summary 

it'll describe what that change is doing. I think 

it should be readily identifiable. 

 DR. ZIEMER: Can you give us an example, 

Ted? Maybe just before we leave here today? 

 MR. KATZ: For example, if you look under -- 

in the probability of causation rule, if you look 
for your change in terms of incorporating the 

Board's role in reviewing updates, then look at the 

summary section of the preamble for section -- seems 

like it would be 81.12, I think, and there should be 

indication there that that's added. 

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 204

 (Pause) 

 DR. ZIEMER: Okay, look on page 60, Ted, 

this is what -- (Reading) In the summary below, HHS 

indicates all the changes in the provisions made 

since the notice of proposed rule-making. 

 Then it goes through it section by section. 

 Is that what you're saying? 

 MR. KATZ: Yes. 

 DR. ZIEMER: That begins on -- for part 81, 

begins on page 60, I believe. 

 MR. KATZ: So for example, look on page 63, 

the full paragraph. 

 DR. ZIEMER: Page 63, the first full 

paragraph where it says (Reading) Section 81.12 was 

added in response to comments -- da, da, da. 

 You see what Ted is saying? So beginning on 

page 60, it goes through it section by section and 

tells what the changes were. 

 So again let me suggest that with that in 

mind that you can individually digest that, either 

during the next hour or throughout the evening 

ahead. And then if there are questions, then we can 
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 205 raise them tomorrow morning. Henry? 

 DR. ANDERSON: This is more just curiosity. 

 Frequently in the Federal Register responses it 

indicates not just an anonymous set of comments 

received or several people or two people, it usually 

says so-and-so or an organization. I'm just curious 

why in this instance they're not identified. I mean 

you can go to the web site and get the actual 

comments, but it doesn't say -- and often that is 

helpful to understand, was it a public individual or 

was it an organization and were many of the things 

you responded to all coming out of one individual or 

one comment or -- just curious as to -- 

 MR. KATZ: Yeah, and there's no beautiful 

answer for that. It just -- it just wasn't the 

approach we took. 

 DR. ANDERSON: It was just quicker to do it 

this way? 

 MR. KATZ: We just left it -- no, I mean not 

even quicker. It would have been just as quick, but 

it just would have -- out of a lot of verbiage that 

wouldn't have been enlightening, I think, so we left 

it anonymous like that. 

 DR. ZIEMER: Well, of course in some cases 

if you identify who the commenter is, people give 

more or less weight to that comment -- 

 DR. ANDERSON: Right. 
 DR. ZIEMER: -- in terms of how it's 

handled. 

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206

 DR. ANDERSON: Or if you were a commenter 

and you looked -- gee, I wonder if they're 

responding to my comments. It's difficult. 

 MR. KATZ: Right, but we had -- you know, 

two-thirds of the commenters were individuals who 

for most readers wouldn't be known. 

 DR. ANDERSON: Yeah. 

 MR. KATZ: And I think there's no tradition 

of using individuals' names in anyway, so those 

would have been left out. 

 DR. ANDERSON: That's okay, I -- you know. 

That's fine. 

 DR. MELIUS: I think what we're telling you 

is it would be enlightening and I think my -- to 

have individual names, and I believe that's what 

often is done with OSHA regs, which I've read. 

Preambles will include who provided the comments and 

names and so forth, and I think it is useful. 

 MR. KATZ: So the next time -- the next time 

we promulgate these rules we'll perhaps take a 

different course. 

 DR. ZIEMER: I want to ask again the Board's 

wishes. Do you wish to adjourn or recess at this 

point for the day, or are you so energetic -- okay. 

 Henry does not wish to recess. 
 DR. MELIUS: I have one other important 

point. I think the committee should all recognize 

that it was Larry Elliott's birthday yesterday and 

wish him happy birthday. And probably should wish 

him happy birthday today because he probably aged 

another year putting up with us all day, so happy 

birthday again. 

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207

 DR. ZIEMER: I thought that aged look was 

from the work and now it's just natural aging. 

Right? 

 MR. ELLIOTT: Thank you. 

 DR. ZIEMER: Happy birthday, Larry. Well, 

we're getting sufficiently jovial that I'm sure the 

day is over for serious work, so we'll declare a 

recess till tomorrow morning and -- what's our time 

in the morning? -- 8:30. Okay, 8:30 in the morning. 

Thank you. 

 Remember to take all your stuff. 

 (Whereupon, a recess was taken to Friday, 

May 3, 2002 at 8:30 a.m.) 
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208 Presidential Advisory Committee

Department of Health and Human Services

Centers for Disease Control and Prevention (CDC)

 National Institute for Occupational Safety and Health 

 (NIOSH)

Advisory Board on Radiation and Worker Health

 VOLUME II 

 The verbatim transcript of the Meeting of 

the Advisory Board on Radiation and Worker Health 

held at the Washington Court Hotel, 525 New Jersey 

Avenue, N.W., Washington, D.C., on May 2 and 3, 

2002. 

NANCY LEE & ASSOCIATES 

Certified Verbatim Reporters 

P.O. Box 451196 

Atlanta, Georgia 31145-9196 

 (404) 315-8305 
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209 C O N T E N T S

 Vol. II 

Registration and Welcome 

Dr. Paul Ziemer, Chair 

Mr. Larry Elliott, Executive Secretary . . . . . . . 227 

Administrative Housekeeping 

Ms. Cori Homer, NIOSH . . . . . . . . . . . . . . . .227 

Discussion of Rules. . . . . . . . . . . . . . . . . 237 

Legislative History 

Dr. David Michaels, George Washington University. . .268 

Public Comment Period . . . . . . . . . . . . . . . .327 

Adjourn . . . . . . . . . . . . . . . . . . . . . . .344 

 
 The following transcript contains quoted material. 

Such material is reproduced as read or spoken. 

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 TRANSCRIPT LEGEND 210

 In the following transcript a dash (--) indicates an 

unintentional or purposeful interruption of a sentence. 

An ellipsis (. . .) indicates halting speech or an 

unfinished sentence in dialogue or omission(s) of word(s) 

when reading written material. 

 In the following transcript (sic) denotes an 

incorrect usage or pronunciation of a word which is 

transcribed in its original form as reported. 

 In the following transcript (phonetically) indicates 

a phonetic spelling of the word if no confirmation of the 

correct spelling is available. 

 In the following transcript "uh-huh" represents an 

affirmative response, and "uh-uh" represents a negative 

response. 
 (8:40 a.m.) 

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 P R O C E E D I N G S 211

 DR. ZIEMER: Well, good morning. I'll 

officially declare us back in assembly and ready to 

go to work. We have several housekeeping things to 

take care of. I guess the first one is the issue of 

pictures for the web site. There's been a request 

that our pictures -- pictures of the Board be put on 

the web site. It's not mandatory that you do this, 

but if you're willing to, you do need to sign a 

release and then Ted Katz is going to be the 

photographer, have a beautiful portrait of each of 

you on the web site, action shot -- candid action 

shot, so who knows what it'll look like. No one 

will ever recognize you anyway. 

 Let's see, let me ask Cori for housekeeping 

-- is Cori still here? Yeah, do we have some 

housekeeping things pertaining to either travel 

forms or other things that the Board needs to 

address? 

 MS. HOMER: Just that everything's been paid 

-- or should have been. If you haven't been 

reimbursed for either travel voucher or salary, 

please let me know. I also have amounts, if you're 

curious about what should have gone into your direct 

deposit account, please ask me. I might can give 

you a general date when that should have gone into 
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 212 your account. 

 DR. ZIEMER: Are we at a position to look at 

the schedule for next meeting yet? I know that you 

passed out calendar -- 

 MS. HOMER: I gave those to you -- 

 DR. ZIEMER: Oh -- 

 MS. HOMER: -- and Larry. 

 DR. ZIEMER: Oh, we're the only ones that 

have these? 

 MS. HOMER: Yes. 

 DR. ZIEMER: Is everyone's -- Are everyone's 

bad dates on here? Well, we'll come back to that in 

just a moment then. 

 Let me also remind folks that if you have 

additional time in preparation for this meeting, you 

need to let Larry or Cori know what that is as well. 

 MS. HOMER: I'd also like to remind 

everybody that when you're calling the hotel to make 

your reservations, please remember that the rooms 

are on a block. Just in case you call and they say 

oh, gee, we don't have your name, the room is either 

blocked under NIOSH or CDC, and if you have any 

problems making your reservations or reservation, 

please let me know and I will contact the hotel and 

find out what the problem is. I think that's about 

all I have. 

 DR. ZIEMER: Before we talk about setting a 
21 date, let's talk a bit about our work schedule and 

upcoming things. We have talked about some topical 

issues that may be somewhat dependent on 

availability of experts to address the group. We've 

talked -- very preliminary way -- about issues of 

how we assess, monitor, evaluate dose reconstruction 

activities, and that may be on down the road a bit, 

but we need to begin to formulate some strategies 

and plans as to how we will go about that. 

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 We also need to have some idea of when the 

Special Exposure Cohort materials will be ready. I 

think there's a -- and I'm not asking you to commit 

to a certain date, but I think -- I get the feel 

that they might be ready within a couple of weeks. 

Is that unrealistic or -- I'm thinking in terms of 

the possibility of getting those out to the Board, 

maybe at least a couple of weeks in advance of a 

meeting, and then we can go from there and say okay, 

what's the time frame for setting our next meeting. 

 It seems to me that may be a critical point. 

 MR. KATZ: Yeah, thanks, Ted Katz. Dr. 

Ziemer, I think it's probably -- I mean we would 

hope they'd be out in two weeks or so. 

 DR. ZIEMER: And I don't -- I'm not asking 

for a promise -- 

 MR. KATZ: No, no, no -- 

 DR. ZIEMER: -- but I want us to be 
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 214 realistic. If it's going to be -- 

 MR. KATZ: The other I just wanted to -- 

 DR. ZIEMER: -- three weeks or four, just 

say that. 

 MR. KATZ: Right. I mean it's only a 

question of -- I think a lot of people are in the 

review chain in other departments or have a very 

busy week next week, so I don't know how things are 

going to go that respect, but I think that's 

reasonable. 

 The other thing I just wanted to mention for 

you to consider is that right now we're planning on 

a 60-day public comment period, but we would -- we 

need to adjust that -- we'll need to adjust that, 

depending on what sort of date you decide on because 

we want to, as has been made clear in comments that 

the Board and so on -- we want to be certain that 

you have plenty of time to review these procedures. 

 So once we settle that, we'll adjust the procedures 

accordingly. 

 DR. ZIEMER: Well, it would appear that 

perhaps the earliest we might be talking about would 

be a month from now, but that may be a little bit 

optimistic if we want to allow some advance time for 

the Board to review the materials before the 

meeting. I just happened to notice on my calendar 

that from June 10th until June 24th I'm out of the 
21 loop and you are, too. We're probably at the same 

meetings. American Nuclear Society is in that 

period, and I have some other ones going on -- they 

all pack together. And going earlier, that is the 

first week of June is just a month from now and I 

think that may be pushing a little bit. So then 

we're into, at the earliest, the last week of June 

or into early July. So I think realistically that's 

where we need to start looking at calendars. 

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 Let's see, on this summary that I got from 

Cori, I don't -- no, actually I guess we need to ask 

you to look at your calendars because not 

everybody's name is on here. The ones who are named 

are all available the last week of June. And let's 

see, Sally's availability for July, unknown. 

 In June. 

 MS. GADOLA: July. 

 DR. ZIEMER: In July, okay. Well, let's 

find out how the last week of June is first. Anyone 

for whom the last week of June is bad? 

 DR. MELIUS: Thursday of that week is 

(inaudible). 

 UNIDENTIFIED: Yes. 

 DR. MELIUS: I don't know if that's going 

to -- 

 DR. ZIEMER: That would be June 27th? 

 DR. MELIUS: 27th, yeah. 
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 DR. ZIEMER: 216 So that's out. 

 DR. MELIUS: That's just a one-day meeting. 

 MS. HOMER: That's just one day, but I'm not 

-- you're there. And we could actually possibly 

(inaudible). 

 DR. MELIUS: Yeah, it's not (inaudible). 

 DR. ZIEMER: It's a bad week for Larry, so 

let's just rule that week out. 

 Let's look at the first week of July. Of 

course there's the July 4th holiday in there which 

would be probably not a good time for most folks. 

Some folks are out barbecuing and things like that. 

 MS. MUNN: Well, if we did it Monday and 

Tuesday, we'd all be home. 

 DR. ZIEMER: 1st and 2nd? Let me ask -- 

those for whom the 1st and/or 2nd would be bad? So 

the 1st -- oh, it would be bad. 

 MR. PRESLEY: I could change my schedule if 

it's good for everybody else but me. 

 DR. ZIEMER: So possible 1st or 2nd -- 3rd 

is not good? Getting too close to the holiday? 

 UNIDENTIFIED: Travel would be bad. 

 DR. ZIEMER: Be bad? Okay. And of course 

the 5th would be out because it'd be just a single 

day. How about the week of the 8th? 

 DR. DEHART: I'm not available. 

 DR. ZIEMER: All week? It's out, that week. 
217 Week of the 14th -- 15th? Week of the 21st? Well, 

let's see, I'm out the 23rd and 4th, 5th and 6th. 

Well, that's -- yeah, that is pretty much it. Okay. 

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 And then finally, the last week of July, 

which carries over into the first of August. 

 DR. MELIUS: That's bad for me. 

 DR. ZIEMER: Bad for you. Whole week? 

 DR. MELIUS: Whole week. 

 DR. ZIEMER: Okay, bad for you. Now we 

actually have two days where we could even possibly 

meet, that's July 1st and 2nd, and my -- Robert, you 

said you could possibly rearrange? 

 MR. PRESLEY: If everybody else can meet, I 

could rearrange. 

 DR. ZIEMER: Why don't we pencil that in on 

people's calendars and, depending somewhat on how 

things develop there, if we can shoot for that and 

that's basically two months from now. Or actually 

-- yeah. Let's see, no, that's -- yeah, that gives 

you most of May and all of June. 

 MS. HOMER: I'll check the availability 

dates on the hotel. Or if you'd care to, we could 

have it someplace else. 

 DR. MELIUS: I really think we ought to 

start meeting outside of Washington in order to get 

just a little bit more public -- at least the 

possibility or -- of public participation. 
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 DR. ZIEMER: 218 Suggested locations? 

 MR. PRESLEY: I don't mind you all coming to 

Oak Ridge, but I'd need more than two months to try 

to get things organized. 

 MS. MUNN: As I've said before, you're 

certainly all welcome to come out to the 

west coast. MS. MURRAY: Put your 

microphone on. 

 MS. MUNN: Although I understand the plea 

for more public availability, from my point of view, 

coming into Washington, D.C. is much simpler than 

trying to get to another smaller, less easily 

available from Seattle location. 

 DR. ZIEMER: Other suggestions? 

 UNIDENTIFIED: We can do it in Cincinnati. 

 DR. MELIUS: Denver, relatively accessible 

from everywhere (inaudible). 

 DR. ZIEMER: Denver also is close to a DOE 

site, namely Rocky Flats. 

 DR. MELIUS: And there've been a number of 

public meetings out there so (inaudible) we've had 

active participation in the past. 

 UNIDENTIFIED: It's also going to be hot in 

(inaudible). 

 DR. DEHART: Yeah, Denver sounds a little 

cool. 

 DR. ZIEMER: Okay, I don't know if that's a 
groundswell for Denver, but could we at least 

investigate Denver as a possibility? You might want 

to have a default. I mean some of the -- well, this 

isn't that big a meeting, so it may not be so hard 

to -- 

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 MS. HOMER: No, it all depends on the season 

and depends on availability, but I'll check. 

 DR. ZIEMER: Right, we'll look at Denver as 

a possibility. Other locations that are easy to get 

to and that are relatively near DOE sites include 

Chicago, which is near -- which is basically where 

Argonne is, although that's not quite as critical a 

site for these kinds of activities, but nonetheless, 

there are folks there. 

 MS. HOMER: Cincinnati -- 

 DR. ZIEMER: And Cincinnati. Right. 

 Okay, we'll ask the staff to look into those 

possibilities. Any other housekeeping issues? I 

want to also indicate that if David Michaels does 

arrive before his appointed time, if it's agreeable 

I'd like to start him virtually right away if he 

gets here early. The reason being that some of the 

members -- some, I know that Tony's plane leaves at 

noon, which means nowadays you can't do what we used 

to and that's to leave from downtown about 30 

minutes before flight time and expect to catch a 

flight, so Tony would probably have to leave about 
2 10:30. And so if Dr. Michaels does arrive early, 

we'll try to put him on. 

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 Then in the meantime we'll proceed. There's 

at least one item that we want to spend some time 

on, and possibly a second. The first item would be 

now to go back and see what additional questions 

folks have on the final rules as far as the 

clarification issues that were raised yesterday. 

 And then also if we have time, I think it 

would be useful for us to do a little brainstorming 

about how we might approach in the future the issue 

of our role in the dose reconstruction activities, 

monitoring, assessing, evaluating, whatever it is we 

wish to do. 

 So let's proceed -- shall we proceed first 

with Part 81? And Ted, you need to also be on deck 

to help answer questions, I suppose. And what I 

myself had been looking at was, beginning on page 22 

and going through the public comments and kind of 

looking at what the comments were and how the staff 

handled those, I'm right now -- I'm sorry, I'm on PC 

-- POC, probability of causation. That's Part 81. 

Maybe there aren't any questions on that, but if 

there are, we need to take this opportunity and then 

we'll go on to Part 82. 

 But I assume that in general the kinds of 

questions that were raised about how the staff 
22 addressed and resolved public comment issues maybe 

applies to both, so let's at least -- if there are 

concerns or areas where the Board wishes to raise 

questions or ask questions or make comments, let's 

-- if this is agreeable, we'll just systematically 

go through these areas, and if there's no questions 

or comments, we just move on. Is that agreeable? 

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 1

 So I'm looking, beginning on page 22 of the 

draft that we have, and I don't know if members of 

the public have any of this, but -- or where it 

would be if -- are the actual real versions now back 

on the table? 'Cause I can give I think maybe the 

section number. No, they're not available yet? 

Okay. 

 Well, let's proceed, in any event. The 

first topic was the appropriateness of adopting 

compensation policy used for atomic veterans, begins 

on page 23. And what I'll do is just pause and see 

if folks have concerns. I assume as you reviewed 

this if you had issues, you probably made marks and 

-- or highlighted or whatever. 

 How about item (b), compensability? 

 (Pause) 

 DR. ZIEMER: Okay. Item (c) on page 26, 

need for peer review? This included some public 

concerns about this Board's expertise in reviewing. 

 Yes? 
 DR. ANDERSON: 222 I guess I would go back to a 

question I had on (a) as far as the response. It's 

more of an administrative response as to why was -- 

why the tables and things were used. I think it 

would have been helpful and at some point to -- and 

that may be when we get into the compensation side, 

the doses are really quite different, the types of 

exposures are different between the atomic veterans 

and this particular group. And at least as I took 

the commenters' question was more to the issue is 

the compensation program for atomic veteran-type 

exposures appropriate for individuals who would have 

far lower and often more chronic exposures. 

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 DR. ZIEMER: Okay, and perhaps Ted can 

answer that. 

 DR. ANDERSON: I mean I don't know what the 

-- I haven't looked at the commenter. I'm just 

saying that's one issue, and as we move forward 

it'll be important to explain to the public why 

systems set up -- 

 DR. ZIEMER: We do understand and I believe 

this is correct that the law itself requires the use 

of the probability of causation and the NIH tables 

as updated. 

 UNIDENTIFIED: Yes, yes, yes, right. 

 DR. ANDERSON: I know it requires it, but -- 

 DR. ZIEMER: But you're just -- 
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 DR. ANDERSON: 223 -- but I'm just saying the -- 

 DR. ZIEMER: -- saying it's not clear to 

the -- 

 DR. ANDERSON: -- I mean what Congress does 

is hopefully consistent with the science and I'm 

just saying that at some point I would expect -- at 

least the questions that I've gotten from a few 

people has been what's the underlying science, is 

that science appropriate, and I think at some point 

-- and I haven't looked at all the things on the web 

site, maybe there is an explanation of why exposure 

is exposure -- 

 DR. ZIEMER: Yes, and actually you're in a 

sense raising a deeper question that's come up in 

this Board in somewhat different ways at different 

times, and that is the issue of the narrative that 

describes the intent of Congress and how much that 

intent of Congress reflects scientific reality -- 

 DR. ANDERSON: I didn't want to put it -- 

 DR. ZIEMER: -- with all due respect -- 

 DR. ANDERSON: -- quite that way, but that 

was the gist of what I was saying. 

 DR. ZIEMER: With all due respect to the 

intent of Congress. And in fact, perhaps Dr. 

Michaels will help us understand that, as well. And 

I shouldn't say that in a derogatory fashion. 

Actually it's a view of reality that differs from 
some other folks's view on a number of issues, 

including dose-effect relationships, including how 

one uses probability of causation and a number of 

other issues. And on none of these are there really 

clear right or wrong answers. There are scientific 

disagreements clearly on a number of these issues, 

and some of the underlying assumptions to those 

issues, as well. 

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 DR. ANDERSON: I'm just trying to anticipate 

that if we start to have meetings out where we'll 

have more public participation, I would expect those 

may be the kind of questions. And to say well, 

that's what the law says -- 

 DR. ZIEMER: That may not be satisfying. 

 DR. ANDERSON: That's not very satisfying, 

so I think to have an explanation as to why this is 

-- that having consistency also fits with some of 

the others that would I think be necessary to -- 

 DR. ZIEMER: So you're not real happy with 

the idea of saying yeah, it doesn't make sense but 

Congress wanted it that way. 

 DR. ANDERSON: Right. Right. 

 DR. ZIEMER: Thank you. I've got to be 

careful how I state these things. I mean that in a 

friendly fashion. 

 Okay. Other comments? Yes. 

 MR. GRIFFON: Just to follow on to that 
point, I mean I think you're right that it did 

require the NIH -- the adoption of the NIH tables, 

but as updated, as you said, so NIOSH did have an 

opportunity to update those and they did consider 

the DOE epidemiological studies, made a -- you know, 

I think again we want to see the basis, and I'm not 

saying right or wrong. I think timing and a wide 

variety of study results was one of the reasons they 

didn't use many of the DOE epi studies to be 

incorporated in the IREP model, and probably rightly 

so. But I think we need to see more of that basis 

again so that we have an understanding of that 

process. 

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 DR. ZIEMER: Okay. We'll jump back to -- I 

think the point where we were back in (c), need for 

peer review. Any comments on that? 

 DR. ROESSLER: Under (c), peer review on 

page 27, I'm pleased to see the line in there, in 

that first paragraph (Reading) Moreover, the Board 

maintains the option to commission additional 

independent scientists to participate in the Board's 

review. 

 I think when we're questioned by our 

colleagues about the expertise on the Board, that 

always is a drop-back or a way to get more review. 

 DR. ZIEMER: Thank you. 

 MR. ELLIOTT: Let me comment on that, just 
226 in the way we would handle that so that everybody at 

this point understands how we would proceed. If the 

Board's pleasure is to seek some expert consultation 

to support your review, we can make that happen 

through what we call a fee for service, and that's a 

pretty expedited process. We just need to know who 

it would be that you would like to seek out for 

consultation and we can put that in place. 

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 DR. ZIEMER: Okay. Item (d), updating 

NIOSH-IREP to remain current with science. 

 (Pause) 

 DR. ZIEMER: No comments? Item (e), 

chemical or non-occupational radiation exposures as 

risk factors. 

 (Pause) 

 DR. ZIEMER: Item (f), covered exposures. I 

might insert here a comment. Henry, this is similar 

-- the same sort of thing. It simply invokes the 

requirement of the law -- although it does explain 

why. I mean the law limits it to the radiation 

exposures or perhaps radiation plus something, but 

not other things. But there is at least now a 

reason for that in terms of available science, but 

it -- another one of those where we need to be sure 

as we go forward in interacting with the public that 

there's a reason that the law is the way it is. 

 DR. ANDERSON: Back to the interactive 
22 effects, at some point I think it would be helpful 

as just kind of an informational piece for us to 

have somebody from NIOSH or elsewhere come in and 

kind of give us the state of the art on interactive 

effects, and that could then lead us to a 

recommendation or support of a research activity or 

something like that. I think it'd be -- this is 

certainly one that was raised by the public and be a 

good idea to get a sense of where it's at, what's 

the -- 

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 DR. ZIEMER: That's a very good point, and 

in fact it would be nice to have kind of a summary 

of what research is underway, if that can be 

determined. I'm aware of the fact, for example, 

that even as we speak NIOSH itself -- another part 

of NIOSH -- has on the street a request for 

proposals for studies relating to, among other 

things, mixed exposures. By mixed in this case I 

mean radiation plus other agents. 

 Item (g), covered illnesses? 

 (Pause) 

 DR. ZIEMER: No comments? Okay. Item (h), 

radiation dose threshold for calculating probability 

of causation. Yes, Gen? 

 DR. ROESSLER: Again, I'm pleased to see 

several paragraphs in here addressing this. It's 

very controversial and I think it's explained or 
228 it's stated very well here, so I think that's a good 

part of this section, both with regard to threshold 

and the uncertainty. They're both addressed here 

and those are questions that come up frequently. 

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 DR. ZIEMER: Thank you. And also, Gen, the 

grouping of the rare cancers, and you raised the 

question yesterday on those and that's discussed 

here, too. 

 DR. ROESSLER: That's what I meant by the 

uncertainty, that part, yes. 

 DR. ZIEMER: Okay. Item (j), documentation 

of IREP. 

 (Pause) 

 DR. ZIEMER: I'm sorry, what's that? Oh, I 

missed, okay, bottom of the page there. Yes, sorry. 

 Were there comments on that one? I knew there were 

none and I just skipped it. Okay, none on item (i) 

-- (j), documentation for IREP? Okay on that one? 

 (Pause) 

 DR. ZIEMER: I want to ask Mark Griffon -- 

'cause you raised issues yesterday I think about the 

sort of transparency of documentation, so are you 

comfortable at this point as to where it's going on 

-- 

 MR. GRIFFON: I think they've addressed that 

in the final version, the model details that I'm 

requesting will be in the final version. I'm 
confused why they aren't right now, but that's a 

separate issue, so I think they've addressed that, 

yes. 

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 DR. ZIEMER: Item (k), technical elements of 

IREP? 

 (Pause) 

 DR. ZIEMER: Jim? 

 DR. MELIUS: Just a comment. I would note 

that almost all these subjects are things that we've 

asked for further updates and further discussions 

of, so not to fault what's here, but I think they're 

all worthy of more attention. 

 (Pause) 

 DR. ZIEMER: Item (l) begins on page 50 of 

your document. It's discussion at this point on 

Part 82. Right? Within the context of this rule. 

But it's the section under dose reconstruction 

program as set forth in 82. I'm trying to 

understand why it's here. Oh, it's because the 

comments came in under 81 but they actually related 

to -- I'm sorry. 

 It's the fact that the comments were 

submitted as Part 81 comments, but they actually 

pertained to Part 82, so they are dealt with here. 

 DR. DEHART: Paul, could I come back just a 

minute to the rather lengthy section we just left -- 

 DR. ZIEMER: Too late, you missed it. No, 
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 230 please, go ahead. 

 DR. DEHART: The issue of age, was that on 

our list of items to -- 

 DR. ZIEMER: Age at exposure? 

 DR. DEHART: Yes. 

 DR. ZIEMER: I think that was on the list. 

 MR. GRIFFON: I was just going to say part 

of that is also part of the healthy survivor effect; 

it's sort of tied together, so I think we've... 

 DR. ZIEMER: Item (m) is Special Exposure 

Cohort, a very brief discussion there. It simply 

refers to the fact that a separate document's being 

developed. 

 Item (n), Department of Labor 

responsibilities. 

 (Pause) 

 DR. ZIEMER: Now I think that's the last 

section dealing with comments other than the 

comments that this Board submitted, and those are 

dealt with and I think we're all aware of both our 

comments and their -- and the outcomes. 

 Now let me simply pose the question. Is 

there anything in the body of the rule, after having 

gone through the comments, in terms of how the 

actual rule finally ended up being worded. Any 

questions on that? I mean the rule is now the rule, 

but if -- well, I think if there are things that 
23 really stick out that we're uncomfortable with, it 

doesn't hurt to point those out. I mean I think in 

terms of -- because we reviewed the draft rule in a 

fair amount of detail before and reached a certain 

comfort level, and now the level of discomfort 

revolves more around both the process and the policy 

issues surrounding how the decisions are made 

concerning changes and going forward. 

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 Now let's -- are we okay to move ahead to 

Part 82? 

 (Pause) 

 DR. ZIEMER: Henry? 

 DR. ANDERSON: Just on page 82 I notice it 

lists cancer diagnosis by ICD-9 code -- 

 DR. ZIEMER: Which one are you in? 

 DR. ANDERSON: I'm in the actual rule. 

 DR. ZIEMER: 82? 

 DR. ANDERSON: 81, but page 82. 

 DR. ZIEMER: Okay. The question on -- is 

this on the use of radiation dose information? 

 DR. ANDERSON: Under the -- yeah -- no, it's 

at -- no, up above that, it just lists (b) as cancer 

diagnosis by ICD-9 and of course now ICD-10 is out 

so I assume there's no -- there will be a conversion 

table or whatever or -- I mean that's a 

technicality, but -- 

 DR. ZIEMER: How is that handled? Is it 
232 automatic that you use the latest version or is this 

codified in a way that it's not readily changed? 

Ted, can you answer that? 

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 DR. ANDERSON: It's more in the program 

issue. 

 MR. KATZ: Yeah, I think it's just an 

implementation issue, so DOL will have a 

correspondence table or whatever, but it's not a 

problem in terms of the -- 

 DR. ANDERSON: You'll take the literal 

string and this is -- it would seem to me this is 

only going to apply -- you're going to put the code 

in so that it calls up the right things -- 

 MR. KATZ: Right. 

 DR. ANDERSON: -- when you do the causation 

program and people just have to remember -- 

 MR. KATZ: Right, and this is how we get the 

right risk model. 

 DR. ANDERSON: Yeah, and you'll just need to 

have a failsafe in so that if somebody puts in the 

wrong -- 

 MR. KATZ: Yes, they'll be fired. 

 DR. ANDERSON: It won't get attributed to 

the liver when it's something else. 

 DR. ZIEMER: Malpractice on the code itself, 

okay. Thank you. Now I'm looking for my start page 

here on Part 82. Oh, here we are, it's page 13, 
summary of public comments. The first group of 

comments had to do with the purpose of the rule, so 

let me ask if you have any questions or comments on 

that. That begins on page 14. 

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 (Pause) 

 DR. ZIEMER: Claimant involvement, beginning 

on the bottom of 17. 

 (Pause) 

 DR. ZIEMER: Basics of dose reconstruction, 

page 22. 

 (Pause) 

 DR. ZIEMER: Who receives dose 

reconstructions, page 25 and following. Yes? 

 DR. ANDERSON: Just one thought that -- and 

we don't know the -- how quickly things will move, 

but for many of these individuals who have cancers, 

their life span may be relatively short and 

therefore the need to do an interview early on -- 

you know, somewhere in here you may need to get a 

sense of at what stage are they in their malignancy 

and their life expectancy so that the process of 

going back to reconstruct and whatever might take 

longer than the person's expected life expectancy, 

and then when it comes time to get interview, your 

first line person who has personal knowledge is 

gone. So NIOSH may need to take into account -- I 

don't know if it was written in here or -- it 
wouldn't make sense to have it in the rule, but 

there needs to be -- 

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 DR. ZIEMER: I think as a practical 

matter -- 

 DR. ANDERSON: -- that would be one thing -- 

we may want to track how many people file, and then 

you may want to go -- leapfrog into an interview, 

even though you're -- subsequently it may take 

months to get the records. 

 DR. ZIEMER: I think that's already 

happening, but Larry, would you fill us in? 

 MR. ELLIOTT: Sure. Surely. Of course 

we're not going to be able to know each and every 

situation's -- case's situation, but where we are 

made aware of an individual who is in dire straits, 

approaching their end, we have made a special 

category which we call compassionate, and we have 

instigated and initiated the interview as quickly as 

possible. We have several of those in that 75 that 

I talked about earlier. 

 DR. ZIEMER: That wouldn't necessarily be 

covered in the rule-making, but as a practical 

matter, they're doing that. Or trying to do that. 

 Okay, we were on item (d), who receives dose 

reconstruction. Anything else there? 

 Item (e), establish a time limit for dose 

reconstruction. 
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 235 (Pause) 

 DR. ZIEMER: Okay, (f), use of records and 

information. 

 (Pause) 

 DR. ZIEMER: Okay. Item (g), this is 

specifically on the claimant and co-worker 

interviews. 

 (Pause) 

 MR. GRIFFON: I'm sorry, just back to (f) 

for one second. I mean I just wanted -- and we 

brought this up yesterday, too, but the -- this just 

brings up the whole bit about access to records, and 

I think the faster that NIOSH clarifies that process 

for the public, I think that'd be beneficial. 

There's one phrase in here that says -- on page 31 

at the top -- the question that one commenter had on 

putting the burden of proof on the claimant, 

potential claimant, and it says that NIOSH -- 

(Reading) And most of the parameters relate to 

information held by NIOSH. 

 And I wonder if that's -- is that -- maybe 

I'm misreading this, but it seems to me that's 

suggesting that NIOSH is going to have a lot of this 

data, and I get the -- I'm of the opinion that some 

of those work histories that I've done at some of 

the sites, they throw a curve ball at me that I 

never expected, but when you go and start to 
23 investigate, they're -- sometimes there's a lot of 

credibility to that, maybe sometimes not, but I 

think it's something that may have to be 

investigated at the individual sites, and you may 

need more data than what you might have initially 

requested, so I think NIOSH is intending on doing 

that, but I think that -- I just wanted to get that 

out there and I think the sooner we know more about 

that process of who is going to have access directly 

to records and how that whole thing is going to be 

handled, I think the public wants to know that and I 

think that's going to lend to the credibility of 

this whole process, too, that people are going to 

feel more comfortable to know that NIOSH had access 

to everything they needed to do the most accurate 

estimate they could. 

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 DR. ZIEMER: I don't know if any of the 

staff have any specific response to that. It seems 

clear to me that NIOSH is very interested in getting 

very complete records, and one of the difficulties 

will be what NIOSH thinks is complete and perhaps 

what the DOE thinks is complete, and therein lies 

part of the issue, I suppose, but I'm speculating 

here. 

 MR. ELLIOTT: The active phrase that you 

left out there, Mark, is that "has the burden of 

conducting this evaluation." It's not DOE, it's 
237 NIOSH. It's not the claimant, it's NIOSH. Whatever 

the claimant can give us only aids us in 

accomplishing a dose reconstruction and so we're 

placing the burden of assembling and reviewing and 

collecting all of the necessary information on 

ourselves and that's what'll go forward 

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 If you recall yesterday I talked about 

developing the case file and developing the dose 

reconstruction portion of that case file. That's 

our burden, and your comment is well-taken and 

absolutely correct. We need to make sure that as we 

work with claimants they understand this whole 

process, and we need to educate the public in 

general about what this process is all about. 

 DR. ZIEMER: It also becomes very important 

for the Department of Energy to cooperate fully in 

making the records available to NIOSH, and this may 

be more than simply personnel dosimetry records 

because there's -- to do -- in some cases the dose 

reconstructions will require survey monitoring 

records and other records, 'cause we know that from 

other kinds of dose reconstructions done for 

epidemiological studies and for other purposes. 

 MR. GRIFFON: That's part of my point and I 

think I'm trying -- maybe I'm reading into this 

commenter or this comment, but I think when they see 

that DOE certification, there might have been some 
uneasiness there about who's controlling this 

process to actually getting the records they need. 

Is NIOSH being handed from DOE or do they have 

actually direct access to get what they need. Maybe 

I'm reading into that, but that's the way -- I just 

think we need to be sensitive to that and make sure 

-- and I think NIOSH has the right intent on that, 

but I just wanted to state that. 

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 DR. ZIEMER: It seems clear to me that NIOSH 

has the lead, as Larry has described. But it's also 

clear to me that there's a dependence upon full 

cooperation by the Department of Energy, and it 

would be -- I think this Board and certainly the 

public has every right to expect the Department of 

Energy to fully cooperate in this effort. Sally? 

 MS. GADOLA: I have a question along those 

lines, and maybe Larry could answer this best. What 

could we do, as a Board, to expedite this process 

and do you have -- and do you have enough funding 

allocated to this process, as you're learning more 

about what all this entails in getting the records 

from the various sites? 

 MR. ELLIOTT: Well, I hear two questions 

there. What can the Board do, and do we have enough 

resources available, and let me answer the second 

one first, 'cause it's easier. Our resources are 

guaranteed in this program to administer the program 
and those funds are in the Department of Labor's 

appropriations, and then they're apportioned to us 

based upon a work plan and budget that we put 

forward to DOL. We think we have attended to that 

sufficiently. 

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 239

 It is the Department of Energy's 

responsibility to provide the records, provide us 

access to the records, and so they have to have 

whatever necessary resources they need to do that, 

and they have to attend to that through their 

funding mechanisms. 

 Now the first question, what can the Board 

do? Is there anything the Board can do to expedite 

the process? I assume you're talking about the 

establishment of this memorandum of understanding or 

establishment of our access, the provision of 

information and records to us that we need. I think 

your vigilance and your expressed concern and your 

continued observation of the process is the way you 

can help. At this point in time I don't see any way 

you can intervene as a Board to speed up the 

negotiation of the language of the MOU and seek the 

signatures that are necessary between the two 

Departments. That's within the Administration right 

now. But your continued vigilance, your continued 

expressed concerns and observations I think is what 

this Board can contribute. 
 DR. ZIEMER: 240 Thank you. Further comments? 

Yes, Henry. 

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 DR. ANDERSON: I guess following up on 

Mark's issue here, it seems like on page 31 at the 

top again it says (Reading) And most of the 

parameters relate to information held by NIOSH. 

 Is the "held by NIOSH" as opposed to held by 

DOE, is this -- is held by NIOSH the same as saying 

information that's held by DOE? Here it says NIOSH, 

but -- 

 MR. ELLIOTT: Read the whole sentence. It 

says "rather than supplied by the claimant" so -- 

 DR. ANDERSON: Right. Yeah, but -- 

 MR. ELLIOTT: -- what we're saying is NIOSH 

has the authority -- the statutory authority here to 

determine what records and what information are 

necessary and pertinent to complete a dose 

reconstruction. And in this -- in the context of 

this passage, we're responding to one commenter who 

said don't put the burden on the claimant. Okay? 

So please don't -- this is the problem with taking 

phrases out of context. This whole sentence refers 

back to that one commenter, and we want the burden 

on us, we don't want it on the claimant. We're 

certainly interested in whatever records and 

information the claimant can provide. We need and 

are interested and will pursue at great lengths what 
2 information and records the DOE has. And once we 

have all of that, it's the information in our hands 

that is the most critical information for us to 

decide upon when a dose reconstruction is complete. 

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 DR. ZIEMER: Okay, thank you. Other 

comments? 

 (Pause) 

 DR. ZIEMER: Section (g), claimant and coworker interviews? 

 (Pause) 

 DR. ZIEMER: Section (h), page 35, 

evaluating exposure characteristics. 

 (Pause) 

 DR. ZIEMER: Section (i), use of ICRP 

models. Gen Roessler. 

 DR. ROESSLER: This is a section that I 

think is particularly well done. It makes it 

possible for us to defend our evaluation that the 

very best science is being used in this whole 

process. It's not only -- well, it's well done. It 

brings up the important points. It's written 

concisely so you can understand the whole situation. 

 The one thing I'd like to point out, though, 

is that as I read through this, I think that there 

may be cases where, on an individual basis, there'll 

have to be decisions made by the dose reconstruction 

team. And this emphasizes the need for us to 
242 establish how an independent review on some sort of 

a -- however it's done, certainly not on every case, 

but there has to be some method to show that we are 

doing or have done an independent review. 

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 DR. ZIEMER: Thank you. Other comments? 

 (Pause) 

 DR. ZIEMER: Section (j), use of efficiency 

measures. 

 (Pause) 

 DR. ZIEMER: (k), types of information to be 

used. 

 (Pause) 

 DR. ZIEMER: Section (l), evaluating the 

completeness and adequacy of records. 

 (Pause) 

 DR. ZIEMER: Section (m) begins the bottom 

of 49, remedying limitations of monitoring and 

missed dose. 

 (Pause) 

 DR. ZIEMER: Section (n), accounting for 

uncertainty. 

 (Pause) 

 DR. ZIEMER: Section (o), completing and 

reporting dose reconstructions. 

 (Pause) 

 DR. ZIEMER: (p), reviews of dose 

reconstructions or dose reconstruction methods. 
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 243 (Pause) 

 DR. ZIEMER: I'd just call attention to the 

comment on the bottom of 59. It's pertinent, Dr. 

Roessler, to the comment you just made, which is -- 

 DR. ROESSLER: I have it marked and 

underlined. 

 DR. ZIEMER: Okay. I call attention to that 

to this Board. This is the last paragraph on page 

59, the commenter indicating that the rule should 

require the Board to conduct an independent review 

of a sample of NIOSH dose reconstructions, and the 

response is (Reading) Since the review is specified 

to be independent, the Board, rather than HHS, must 

determine the procedures for the Board's review of 

the dose reconstruction. 

 And that has to do with the independence of 

the Board and I think it's a good comment. NIOSH 

has recognized that responsibility that we have and 

that's certainly looming big on our horizon. 

 Okay, item (o) (sic), when information is 

inadequate to complete a dose reconstruction. 

 (Pause) 

 DR. ZIEMER: Section (r), definitions of 

terms. 

 (Pause) 

 DR. ZIEMER: And then the last section there 

is (s) on Special Exposure Cohort, and it indicates 
2 here that those comments are outside the scope of 

this rule and will be addressed separately. 

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 44

 And then there are the sections on the 

recommendations of this Board and how they were 

handled, and we're all aware of those. 

 That completes the discussion of the 

response to the public and public comments. Then 

there is the wording of the rule itself, as changed 

to its final form. Any questions on that, or 

comments? 

 (Pause) 

 DR. ZIEMER: Thank you. I think we have had 

opportunity then to look more closely at how the 

various comments were handled. This does not 

preclude pursuit in some depth of those items that 

we identified yesterday as being important as we 

move forward. 

 I want to pause here a minute and see if Dr. 

Michael has arrived yet. Has not arrived; okay, 

that's fine. 

 Let's go ahead and take a brief break here 

-- okay, I'm sorry, a question, Mark, first. 

 MR. GRIFFON: I was just going to ask, is 

there any listing of substantial changes to the 

regulation itself for this for the dose 

reconstruction rule. I've found a few in the 

summary that Ted pointed us to yesterday, but I feel 
2 like I might be missing some. I saw that a table 

for the weighting factors was dropped -- 

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 DR. ZIEMER: And there was a reason -- 

 MR. GRIFFON: Yeah, and I understand why, 

that's fine -- 

 DR. ZIEMER: -- for dropping that so -- 

 MR. GRIFFON: -- but I'm just wondering if 

there's -- that's what I would call a substantial 

change, not just editing. 

 DR. ZIEMER: That's only substantial in the 

sense that they're still using the table, but it's 

used by reference so that if ICRP changes the table, 

you don't have to change the rule. 

 MR. GRIFFON: I'm just -- yeah, but I'm 

just -- 

 DR. ZIEMER: So that's only -- yeah, it's 

substantial in a certain sense, but -- 

 MR. GRIFFON: But are there -- 

 DR. ZIEMER: -- it's not changing how things 

are done. 

 MR. GRIFFON: I'm just looking at section 

82.18, for example. It says there's new language in 

82.18 to specify how NIOSH will select from exiting 

ICRP models, and I was trying to -- I don't have the 

old one to compare, so I'm just wondering -- 

 DR. ZIEMER: Maybe Ted can address that, but 

apart -- we had that concern as to how they would 
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246 update without having to change the rule every time. 

 MR. GRIFFON: Yeah, I think it's a similar 

question -- 

 DR. ZIEMER: I think that's -- 

 MR. GRIFFON: -- but I was just trying to 

see how it was changed. 

 DR. ZIEMER: Ted -- 

 MR. GRIFFON: Reading through it without the 

other one, I couldn't tell. 

 DR. ZIEMER: Is Ted still here, or Larry, 

can you -- 

 MR. ELLIOTT: He's outside right now, sorry. 

 On our web site there's still the prior version 

that was part of the docket. I don't have -- 

unfortunately, we don't have all of these copies 

here for you today. Ted went through yesterday what 

we consider to be substantial changes. He 

identified those for you. 

 You know, one of the biggest changes is -- 

Ted's here, he can perhaps respond to this, as well. 

 Mark's question, Ted, is what other substantial 

changes besides those you perhaps presented 

yesterday, and I don't know how to -- 

 DR. ZIEMER: Or did you identify all the 

substantial ones. 

 MR. ELLIOTT: Did you identify all the 

substantial changes, like dropping the ICRP 
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 247 weighting factors table. 

 MR. KATZ: Yes, I think I -- I think I 

identified all the substantial changes. 

 MR. GRIFFON: The specific one that I was 

just citing was 82.18. It says you added new 

language on which ICRP models would be used, and I 

was just -- because I don't have the old version I 

just wondered -- 

 MR. KATZ: Oh, and that's simply -- I think 

-- 

 MR. GRIFFON: -- how that was changed. I 

was just looking for that. 

 MR. KATZ: -- just clarifying that current 

models, that's all, so that's a word or two, but it 

didn't involve substantial drafting. 

 MR. GRIFFON: So it just doesn't reference 

specific models, it just says -- 

 MR. KATZ: Yes. 

 MR. GRIFFON: -- most current models or 

something -- 

 DR. ZIEMER: And in fact I think this Board 

asked that it not simply say that they use ICRP 

models, because that could be model two or something 

-- or ICRP Report two, but that current models be 

used, so I think it was responsive to this Board's 

request, in fact. 

 MR. ELLIOTT: I think as you -- well, as we 
2 perform rule-making, you should be aware that the 

rules that are put out for public comment, in the 

preambles of each of those rules we have to cover a 

lot of background information that is not here. So 

when you try to cross-walk these documents, the 

final rule with the one that was put forward for 

public comment, you're going to see substantial 

differences in content. Okay? So don't get -- I 

guess my note would be don't get confused by that. 

The preamble of the final rule doesn't cover as much 

background, perhaps. 

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 DR. ZIEMER: I want to give us time for a 

brief break before Dr. Michaels' discussion. Let me 

also remind both the Board -- well, the Board has 

already done this, but any of you public visitors 

who haven't registered, there's a book in the back 

on the table to register your attendance with us. 

Also members of the public who wish to make public 

comment, there's a sign-up sheet there so please 

avail yourself of that, as well. 

 We'll take a break, about ten minutes or so, 

and then reconvene. Thank you. 

 (Whereupon, a recess was taken from 9:45 to 

10:00 a.m.) 

 DR. ZIEMER: We do want to call the meeting 

back to order. I'm hesitating a little bit to give 

all the Board members a chance to reassemble. I 
24 think a couple of them are actually in the process 

of checking out of the hotel, so they may be delayed 

briefly. But in the interest of time, particularly 

since some folks have to catch planes at a 

relatively early hour, we need to proceed. 

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 9

 We're pleased to have today Dr. David 

Michaels with us. As you see on the slide, Dr. 

Michaels is currently associated with George 

Washington University, but an important aspect of 

his background is the fact that during the period 

when this legislation was under development, the 

legislation for the public Act, Dr. Michaels served 

as Assistant Secretary for Environment Safety and 

Health in the U.S. Department of Energy. So in 

terms of his former role and his continuing 

activities in this area, it's very appropriate that 

we gain some insight from Dr. Michaels on how this 

program developed and, as you see, his presentation 

is entitled "Energy Employees Occupational Illness 

Compensation Program"; in our agenda it's referred 

to as "Legislative History" and we're really -- the 

Board, Dr. Michaels, is very interested in the 

development of this legislation and how it developed 

and perhaps some of the underlying -- both 

scientific and political issues that brought it 

about. So Dr. Michaels, we're pleased to have you 

with us this morning. 
 (Negative responses) 

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 DR. MICHAELS: 250 Can you hear me? 

 DR. MICHAELS: Can you hear me now? How's 

that? 

 DR. ZIEMER: Move over a few steps. 

 DR. MICHAELS: Do I need the microphone? 

Okay, I'm on there now. Thank you. 

 DR. ZIEMER: Just a little witticism -- very 

little, very little actually. 

 DR. MICHAELS: I'm sorry. 

 DR. ZIEMER: Go ahead, you're on. 

 DR. MICHAELS: One of the great advantages 

and pleasures in being the Assistant Secretary of 

Energy is essentially to be able to really stand on 

the shoulders of giants. And I was very fortunate 

when I arrived, I had two very illustrious 

predecessors, one of whom was Dr. Paul Ziemer, who 

many times when I was in the midst of difficult 

problems I'd find memos that really covered a lot of 

these same issues and could go back -- and didn't 

have to rethink all these issues and I'm very 

grateful for all the work that he did to make much 

of my work much more easy. 

 Let me also begin by thanking all of you. I 

know that serving on a government advisory panel is 

not particularly well-remunerated and is often not 

recognized at your own institutions as being of any 
importance at all. But I know that NIOSH and my 

understanding of the various agencies of the 

government that are working on this all are very 

grateful for your help and your input, which has 

been very real and useful. And as someone who 

obviously has some personal involvement in this, I'm 

gratified that you were willing to take this on. 

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 So this is really -- I put this together and 

I'm grateful to Larry for asking me to do this 

because it really was a nice opportunity to sort of 

try to compile all these things in one place and 

remember what was done when. As you know, 

legislations often has a tortured history that's 

easy to forget various points, and various people at 

DOE helped me put this together in the last few 

days. So let me move through this and let's talk a 

little bit about this legislation. 

 (Pause) 

 I thought I'd begin with when I was 

confirmed and sworn in late 1998. I was a few 

months behind Secretary Richardson. I was actually 

chosen by Secretary Peña, but Richard -- I was slow 

in getting to work and this actually has some 

significance here. I was finishing teaching a 

semester at City College in New York and Secretary 

Richardson went to Oak Ridge where he was accosted 

by a group of sick workers who said what are you 
going to do about this? And he said if my new 

Assistant Secretary ever shows up for work, I'll 

send him down here and tell him to figure out what 

to do. 

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 I got the message that I needed show up 

soon, so I did, even before finals week, and I 

immediately went to Oak Ridge. And what I learned 

from going to Oak Ridge and from visiting 

immediately sites around the country and talking to 

-- I never got to Anchorage, but immediately hearing 

from Senator Markowski's staff that everywhere in 

the complex we faced this same problem. 

Essentially, first there were sick workers at many 

DOE sites -- not surprising, there were older 

workers who were sick -- but there was a widespread 

perception that toxic exposures were the cause of 

these conditions. And that was true from Alaska to 

Savannah River, and Oak Ridge was obviously an 

important center. But everywhere you went, people 

believed that their exposures were caused by the 

manufacture, testing, cleaning up of nuclear 

weapons, and that was not beyond reasonable belief 

for several reasons. 

 One is they were working with among the most 

dangerous materials that we deal with in industrial 

situations. We were dealing with plutonium, 

beryllium, as well as the normal range of industrial 
hazards -- asbestos, silica, et cetera. But the 

other thing we -- and there was a great deal of 

secrecy. People were told we can't tell you what 

you work with, or we'll tell you what you work with 

but you can't tell your doctor. So that sort of 

compounded the problem. 

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 But in addition -- and this really was the 

key thing I saw, that no one believed DOE had any 

credibility around this issue. And that was 

unfortunate, but the long history of DOE on this 

issue really put DOE in a very difficult place. The 

history of fighting claims when people had made 

claims and lawsuits, DOE fought them. There were 

conditions in Colorado of conditions which DOE 

clearly said were work-related. There were a number 

of CBD claims around the Rocky Flats site -- not 

surprisingly; people were working with beryllium -- 

DOE actually had a screening program. More than 

half the people with chronic beryllium disease in 

Rocky Flats could not get Worker Compensation in 

Colorado, primarily because we had a number of 

different contractors -- we being DOE -- and when 

someone filed a claim, various -- the claim went 

into the system and the various contractors started 

pointing fingers at each other and saying it 

shouldn't be on our bill, even though they weren't 

going to pay the bill; it should be on the other 
254 person -- the other contractor's bill because people 

were exposed over the course of working for at least 

three different employers -- you know, legally they 

were different employers, Rockwell, Dow, et cetera 

-- and DOE was paying the legal bills for each of 

these different contractors to fight each other in 

court over who should pay the bill. Of course the 

people who got nowhere were of course the people 

with CBD who had come to meetings with -- 

essentially attached to oxygen tanks saying how come 

we can't get compensation. 

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 And I hesitated to use this word, but I 

finally decided I couldn't figure out a better one. 

 I know it's a little bit of hyperbole, but antiworker worker's compensation policies. And I don't 

mean to say that there are individuals who say we're 

going to go out and make life difficult for workers, 

but let me give you an example -- a real time 

example. This was when I was Assistant Secretary, 

after we had already announced many of these changes 

that had occurred, we started a beryllium disease 

screening program at Pantex. It was one of the 

later sites because beryllium, while it's -- there's 

a lot of beryllium there, it wasn't machined as much 

at Pantex as at some of the other sites, so anyway, 

we started the first screening program -- 

 DR. ZIEMER: David, I'm going to interrupt 
255 you a minute. We're getting a lot of noise on -- I 

don't know if it's your mike or -- we may have to 

switch back to the podium mike, I don't know. 

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 (Pause) 

 DR. MICHAELS: How's that? 

 UNIDENTIFIED: Okay. 

 DR. MICHAELS: Okay. Now at Pantex, DOE 

told its contractor to start a beryllium disease 

screening program, start -- we started doing LPT 

tests down there. The first beryllium sensitivity 

cases were found even before some of the cases were 

referred for bronchial lavage to work them up, but 

the first sensitivity cases were found. DOE's 

contractor physician, with the full knowledge of 

DOE, said these workers better file worker's comp 

claims just to get your cases going, and we'll help 

you do that. And they filed the first claims and 

those claims came back rejected by DOE's third-party 

administrator, saying beryllium disease is a disease 

of everyday life, you didn't get it in your 

workplace, et cetera, the standard response that 

virtually every insurance carrier sends when they 

get an occupational disease claim. 

 Now several of you look shocked, but this is 

the reality of workers in the -- not just the DOE 

system, but most industrial plants when they file a 

claim for occupational illness. And this was -- we 
were trying to turn DOE around and we said we 

acknowledge that we caused this beryllium disease, 

we want to take care of people, and that was still 

what was happening. So that's why the credibility 

issues were very important and so -- and finally 

there was a proliferation of expensive, no-win 

lawsuits, no-win meaning the government actually 

would win those cases eventually, they would be 

dismissed. But there were suits all around the 

country, not just around beryllium, but around 

radiation. We would generally prevail, at a 

tremendous cost to the government and the tremendous 

frustration of individuals who were suing and the 

very bad press in the communities. 

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 256

 There had to be a way out of this. And what 

Richardson -- he gave me a month. He said figure 

this out; you have till -- it was the end of 

December. He said you have till January 30th; give 

me a proposal. So I took a little bit longer, 

but... 

 So what we proposed originally and took this 

to the White House was essentially FECA, for 

contractor employees -- how many people here are 

Feds? And how many people have been Feds at one 

time? Well, so you know FECA. FECA is the Federal 

Employee Compensation Act. It covers Federal 

employees, all of us who were Feds or are Feds when 
we're injured on the job. It's a worker's 

compensation system. The basic idea was we'd say 

these are contractor employees who are covered by 

state law and we go through all the problems of 

dealing with different contractors and state laws, 

let's eliminate that problem. Let's make it a 

Federal program and have equity with Federal 

workers. 

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 257

 There were some great advantages to that. 

Benefits under FECA -- wage-loss benefits are much 

better under FECA than in any state worker's 

compensation system, and particularly better than 

some of the states where we had big cohorts of 

workers. Tennessee, South Carolina, New Mexico have 

just very low benefit levels. And just as an aside, 

most worker's compensation programs cap wage 

replacement at two-thirds of the state median. And 

of course no one in the DOE complex makes less than 

the state median. In fact, most of them make quite 

a bit more. If you're in South Carolina or New 

Mexico, you make twice the state median wage or 

more. So if you get into state worker's comp in a 

place like New Mexico, even if you get into it 

successfully, your wage replacement is going to be 

pretty bad. 

 FECA, on the other hand, is two-thirds of 

your wage, except if you have dependents, in which 
25 case it's three-quarters of your wage replacement, 

up to the -- essentially the GS-15 or SES levels, so 

there's no cap. It's a much better system. It's a 

more equitable system. 

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 So we recommended that program and said 

cover all toxic-related illnesses and we'll figure 

out a system that either the Labor Department or HHS 

or perhaps the National Academy of Sciences would 

determine what conditions are work-related, but we'd 

get DOE out of the picture. DOE wouldn't adjudicate 

anymore whether a case was work-related 'cause they 

didn't have the credibility -- or frankly the 

staffing -- to do it. 

 It would be an exclusive remedy, which means 

we'd get out of the lawsuit business. People would 

go into the system. They couldn't sue otherwise, 

but they would get a reasonable settlement in this 

program, and it would be administered -- in our 

initial proposal -- by the Department of Labor since 

they administered the largest worker's compensation 

program in the country, FECA. 

 And from the very beginning -- you know, I 

called up Tom Markey, who at that time was the head 

of the FECA program and sort of dragged him into 

this, and they were very willing to help us from the 

get-go and I'm grateful for that. We also wanted to 

include beryllium vendor employees, and this was 
really sort of -- the government's sort of 

stretching its arms out benevolently. 

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 There were a number of sites around the 

country which did work for the nuclear weapons 

complex under contract with the AEC. The contracts 

were so specific they even include clauses which 

said this is what the -- this is the -- essentially 

it wasn't the PEL at the time, but the threshold -- 

the TLV or -- it was the time-weight average is what 

I'm saying. This is the sort of protection you 

should be providing people from beryllium. DOE sent 

or AEC sent in industrial hygienists to look at 

these places. These were really sort of extensions 

of the DOE complex. 

 They were private contractors, many of them 

were in eastern Pennsylvania, and what was 

particularly notable about these places is they had 

all closed down, and they had been closed for, at 

that time, probably more than ten years. There were 

dozens of workers with chronic beryllium disease. 

Not only were their employers bankrupt and gone, but 

their -- the law in Pennsylvania is that you have to 

apply for worker's compensation within 300 weeks of 

last exposure. It's the time of injury, but it's 

interpreted as last exposure in terms of illness. 

 Well, these plants had been closed for a lot 

longer, so all these people were out of luck, and 
they were dying. And Congressman Kanjorski had 

introduced a bill saying we should take care of 

these people just as we take care of other people 

who are exposed to hazards involving nuclear 

weapons. And we thought that was right, because 

they were doing work for the nuclear weapons 

complex. They were getting nothing, and they were 

dying from beryllium disease. 

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 So that was our initial proposal. The White 

House responded, and it was an interesting 

experience for me to learn about -- of course, as 

many of you know, an agency can't have a policy. An 

Administration has a policy. So we took it to the 

White House and we had OMB, the National Economic 

Council and all the other agencies. 

 We immediately were approved for beryllium. 

 I mean it was -- that was such a clear egregious 

problem that we got a response said go ahead, 

propose legislation on beryllium. And the National 

Economic Council, which is the domestic equivalent 

of the National Security Council, was essentially 

tasked to examine the other issues -- should there 

be a larger program, other conditions, is it 

warranted. And that was an interagency process 

involving Energy, but also Labor, HHS, Defense 

Department. 

 And other agencies could all weigh in and 
2 they all had a stake in it. EPA's obviously very 

interested 'cause they have clean-up sites. And the 

Nuclear Regulatory Commission is concerned greatly 

about radiation. NASA has big contractors so they 

were interested, and everybody came to very regular 

meetings to discuss this and we reviewed all the 

extant literature on exposures in the DOE complex. 

We did surveys of worker's compensation issues. We 

did a tremendous amount of work looking at this 

issue. 

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 While this was going on, the Paducah Gaseous 

Diffusion Plant became sort of a front line issue to 

the Energy Department, and there's a Qui Tam suit -- 

that alleged multiple environment safety and health 

allegations around environmental exposures primarily 

-- was filed. It's still under discussion. My 

understanding is that the way Qui Tam suits work is 

the government has a certain time -- these are suits 

alleging that someone has defrauded the government. 

 The government has a certain amount of time to 

decide whether to join in that suit. The government 

originally -- I guess they have six months; they've 

asked for numerous extensions and still, even though 

this occurred I think in 1999, the government -- the 

Justice Department still has not decided whether or 

not to join that suit and they keep asking for 

extensions and spending a lot of money investigating 
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 262 the situation at Paducah. 

 The basic piece of it, though, was that 

recycled uranium was brought in from Hanford and 

that was contaminated with transuranics and some 

fission products, that there was off-site exposure 

as well as inadequate radiation protection for the 

workers. It was revealed in the Washington Post and 

therefore it got a lot of play. 

 We sent a team down there -- really the next 

-- two days later I sent a team of investigators -- 

and we found essentially poor radiological control 

before 1992. And a lot of problems, a lot of 

management-related problems. And a number of very 

-- memos really citing what we thought of as sort of 

egregious behavior. It raised all sorts of issues 

with us and obviously with Congress and with the 

press. One memo, for example -- I quote it from 

here because I thought it would be hard to read up 

here -- (Reading) Neptunium seems to be found in 

reclaimed feed. 

 That was pretty obvious. 

 (Reading) Workers are supposed to wear 

special face masks but they're not controlled -- 

actually too closely, I left the o out there. 

 And then it went on to talk about bioassays 

and there are some new bioassays; they're not great 

but they recommend using them. And (Reading) There 
are possibly 300 people at Paducah who should be 

checked out but they hesitate to proceed to 

intensive study -- this is the contractor in this 

case -- because the union's use of this as an excuse 

for hazard pay. 

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 And it was memos like that that said well, 

we have a real problem here. We had people exposed. 

 Many people weren't told of the exposures. We 

didn't have adequate protection. How do we respond? 

 And this raised essentially two different concerns 

or two different models. One was the Radiation 

Exposure Compensation Act program, which as many of 

you know is an older program that responded to a 

number of different problems of government exposure 

of people to radiation in this case, included 

programs on uranium miners, primarily in the 

southwest, who were exposed to radon in the course 

of work and there were really pretty -- some 

horrendous stories of that history; down-winders, 

primarily in southern Utah, who weren't told when 

radiation clouds were being -- were blown over their 

town after detonations at the Nevada test site. 

That was one set of examples. 

 The other came from the recently-completed 

Human Radiation Experiment panel that was really put 

together by President Clinton, but run out of my 

office before I got there. It was all done by the 
time I was there. Which raised ethical issues, 

saying people who've been exposed without their 

knowledge deserve compensation whether or not they 

get sick, and that was signed by President Clinton. 

 That was the other sort of big example we had to 

look at. 

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 So we put together a proposal -- the initial 

Administration proposal which went through the 

National Economic Council and the OMB essentially 

was -- had two important components. There was a 

third component which I've been told is so minor I 

shouldn't bother talking about, but there's a 

chronic beryllium disease component and the Paducah 

cancer payment. The beryllium disease component -- 

essentially it looked like FECA. It had lost wages. 

 First dollar prospective medical coverage, which is 

essentially from the time someone applies, we would 

cover their medical costs for claims that are found 

to be work-related. The Labor Department felt it 

would be too complicated to reimburse people for 

past medical costs, and the wage replacement also 

would be quite difficult to figure out because many 

of these people -- their plants closed years ago so 

what's the wage replacement if you're unemployed. 

So the idea here came from this idea of liquidated 

damages of $100,000 lump sum rather than wages or 

medical payments, was the initial proposal. And 
2 that $100,000 actually came from Paul Kanjorski's 

bill. 

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 So it was a choice. You would either get 

wages and medical or $100,000. The vendor employees 

were included. It was coverage for berylliumsensitization -- not cash payment but medical 

coverage and surveillance -- and it was an exclusive 

remedy because there were suits around the country. 

 And for the first time it extended the exclusive 

remedy to the beryllium vendor in some cases were 

being sued and the government was -- and this is 

controversial, but many cases DOE was reimbursing 

Brush-Wellman. When Brush-Wellman was sued, DOE 

would reimburse Brush-Wellman for some of its legal 

costs and for settlement costs because of contracts 

that indemnified Brush-Wellman as a vendor, and in 

some cases as a contractor. And so the DOE felt it 

wanted to include exclusive remedy to protect the 

vendors as well because they were being sued and it 

was really -- they were acting as an extension for 

the government. But that was only in some cases. 

It became very controversial which ones. 

 RECA. And RECA, as you know, is a lump sum 

payment. It's exclusive remedy in that you can't 

sue the government. And it was sort of -- it's sort 

of based on this idea that someone was in the wrong 

place at the wrong time when the government did 
266 something they probably shouldn't have done, either 

not tell people about radon exposures in the mines 

or they were living in say St. George, Utah when 

some of the detonations in the Nevada test site went 

bigger than were expected. 

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 RECA is based on the presumption for a list 

of cancers. If you have one of those cancers, you 

are then -- you receive a lump sum compensation and 

the compensation levels are different depending on 

your category within RECA. We added bone cancer 

because of the transuranic exposure. That wasn't in 

there otherwise. And we put in that someone had to 

work in a radiation-exposed job for at least one 

year before 1992 when we judged the radiological 

controls were then -- were improved to the point 

where this wouldn't be necessary. And the payment 

was $100,000 lump sum, no medical coverage, was the 

original proposal. 

 As things developed, we then gathered 

information around the country. We held public 

meetings to hear from workers. We met with 

contractors. National Economic Council's staff 

reports task force has continued. We came up with a 

second proposal, putting together essentially an 

extensive program in response to that requirement 

from President Clinton saying essentially look at 

all the issues and figure out what to do with them. 
 267 The basic model in this other proposal is we 

would have a Federal program for those uniquely 

nuclear conditions. And this was a discussion 

internally within the Administration on should we go 

past -- what's the implications of Federalizing all 

occupational illness, and there was a back and forth 

between a lot of agencies. The decision was made 

that the program would cover only conditions that 

were uniquely nuclear -- in this case, they were 

decided to be radiation and beryllium exposure, even 

though obviously neither of those are unique to 

nuclear weapons but they're predominant in nuclear 

weapons -- and have a state-based program 

administered by DOE for everything else because an 

asbestos exposure at Hanford is no different than 

asbestos exposure down the street at an aluminum 

plant. And we can discuss later why that decision 

was made. 

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 So the decision essentially covered cancer 

and chronic beryllium disease and berylliumsensitivity. The radiogenic cancer model you've 

spent a tremendous amount of time thinking about and 

commenting on really, as you know, was based in the 

radioepidemiologic tables that National Cancer 

Institute originally put together for RECA but were 

never used in RECA, and there's an interesting paper 

by an NCI Fellow named -- Fellow with a capital F, 
268 not a -- at -- name Mark Parisgondola on the history 

of RECA, which if you want to read -- talks about 

how NCI put these tables together but they were 

never used because the community never trusted the 

government enough. And they fought it 

congressionally and Senator Hatch agreed with them. 

 However, these tables were used by the VA in the 

Atomic Veterans Program, and I thought very 

impressively. 

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 We looked at this and we felt -- we didn't 

want to break new ground, but we were trying to 

essentially graft other programs that the government 

had already decided worked into this program. So we 

looked at that program and we said this really does 

work, and so it was modeled on the VA Atomic Veteran 

Program. We'll get to that -- a little bit more 

about that. 

 The Paducah proposal was expanded to include 

all three gaseous diffusion plants. We'd done 

investigations at all of them. We felt we couldn't 

really -- while things may have been a little 

different or worse at Paducah, we couldn't 

distinguish between the three of them. It was poor 

rad protection across the board. And also for 

political reasons we couldn't separate them out. So 

we were willing to essentially extend that lump sum 

payment to all three gaseous diffusion plants, but 
we didn't have the concept of Special Exposure 

Cohort. That came a little bit later. 

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 And then this DOE-based program for all 

other conditions, essentially to eliminate the 

barriers in state comp programs for the remainder, 

and we'd already started doing that. The Office of 

Worker Advocacy at DOE had started -- I was the 

acting director. We were working with our 

contractors, primarily Oak Ridge, trying to get 

people into this system and we were successful with 

a number of cases. And Kate Kempen and Jeff Eagan 

worked very hard on that, and we thought that model 

would be useful -- would work. 

 It was based on the model at Fernald where 

there's a -- there had been a settlement made where 

there's a panel of three physicians that review 

cases of alleged work-related illnesses. There are 

three nationally-renowned physicians who see these 

cases. We talked to them, we looked at their 

statistics. They accepted about a third of the 

cases. They got to know that plant very well in 

terms of industrial hygiene. They looked at all the 

cases. And where they found cases to be workrelated, they say okay, this one's work-related, 

let's get them into the comp system. 

 We thought that's a great model, and so 

that's -- we thought the DOE -- if the DOE really 
27 tried hard, they could make this work, and so that 

was the -- sort of the other conditions. 

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 And finally we were pretty clear about 

including what are now called atomic weapons 

employers. Before DOE built it's whole complex, it 

was using private firms around the country. Some of 

the big ones you've heard of obviously -- 

Mallinckrodt and Lindy and Harshaw did big work, but 

there were smaller plants as well. They should be 

included, too. 

 The Atomic Veteran Cancer Compensation 

Program was our model, as I was saying, for the -- 

what we call here the -- essentially the radiogenic 

cancer part of the program. This compensated 

veterans with cancer exposed to radiation from the 

products made by AEC-DOE, the nuclear devices or, in 

the case of Japan, the nuclear bombs. Veterans who 

had been compensated include veterans who had been 

exposed because they were on-site in Hiroshima and 

Nagasaki shortly after the detonations. They were 

in the south Pacific. They were at the test site. 

There were even veterans who had been compensated 

whose exposure was at Hanford as a result of being 

exposed from the releases at Hanford. So we felt 

also this made sense because the government already 

had made the policy to do this. These were -- we're 

now talking about contractor employees who have the 
271 same exposures to the same devices, and they should 

be compensated in similar ways. 

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 It was a science-based program. Probability 

of causation was estimated through this NCIdeveloped radioepi tables and we knew the NCI was 

updating them and we were expecting a new version 

fairly soon. 

 Now the Atomic Veteran Program actually is 

far more generous in some ways, or more lenient, 

than this program. There are certain presumptions 

in that program. If you're in certain cohorts and 

you develop say multiple myeloma, you're 

compensated. It doesn't make any different what 

your dose is, and there are a number of different 

diseases. We require doses for everything, but that 

program is more lenient, I guess, liberal. But as 

-- you know, for all VA programs, the benefit of the 

doubt goes to the veteran and that's where the aslikely-as-not language comes from. If it's 50 

percent, you know, the benefit of the doubt goes to 

the worker -- the veteran, so it's not more likely 

than, it's as likely as not. And the VA uses the 

system that is in the legislation that you've all 

looked at, more than you probably ever thought you'd 

have to, around the 99th percent confidence 

intervals is -- comes right from the VA, and that's 

their language and they provide that. That's what 
272 they do and this just parallels what they do. They 

don't have it in their legislation, but it was felt 

by Congress that it would be worth putting into this 

legislation just to make it permanent. 

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 So we were trying to follow that, doing the 

same thing, giving benefit -- you know, bending over 

backwards to give the benefit of the doubt to the 

worker, using these same systems that the government 

had already opined on that worked. 

 This then went to Congress. We actually 

never finished a written legislative -- the second 

proposal never actually was submitted by Congress to 

the -- by the Administration to Congress. That's a 

long interagency process to get signed off on the 

legislation. While we're doing that, Senator 

Thompson from Tennessee and Senator Bingaman from 

New Mexico took this on. They had both held 

hearings on this issue and were extremely 

interested, Senator Thompson holding a hearing of 

the Government Affairs Committee, actually Senator 

Bingaman going to a -- doing a meeting in 

Hispaniola. He's got another one I think coming up 

next week. 

 They put together a proposal which they 

introduced as a stand-alone bill. It was very 

similar to the second proposal. They obviously 

changed it in a number of ways. It was not the 
27 Administration proposal. The Administration never 

formally endorsed it. We went back and forth on it. 

 A number of notable differences between our 

proposal and Thompson-Bingaman -- the first was 

mandatory funding, which we now see makes the 

program work. And the reason for mandatory funding 

was in response to what I call the RECA-IOU debacle. 

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 If you weren't following it at the time, 

there was a just outrage that was occurring 

throughout the United States with -- when sick 

workers or more often widows and children of sick 

workers applied under the RECA program and -- I know 

this personally 'cause I have a good friend who 

applied under this whose husband died, was in some 

of the detonations -- they would get a letter saying 

yes, we find you eligible for compensation. But the 

program is out of money. Essentially people got 

IOU's because this was an appropriated program and 

Congress was way behind in funding it. It was 

basically Justice Department and no one at the 

Justice Department at a high enough level really 

cared about it enough to get full funding for it, 

and so you had the government sending out letters 

saying yes, we owe you $100,000. Which, you know, 

this is not supposed to happen. It looked terrible, 

and it was an embarrassment, and everybody in the 

government felt this couldn't continue. 
 274 In fact, as a result of our getting -- once 

this passed, the Justice Department immediately went 

to OMB and said can't we make RECA mandatory as well 

and OMB said of course. It was one of -- you know, 

they talk in Washington a lot about the unforeseen 

consequences, and that's generally thought about as 

being a negative, but in this there are plenty of 

positive ones, that being one of them. And as a 

result of all this -- not just as a result of all 

this, but also the outrage about this, RECA, while 

it's not fully funded, it's very close to fully 

funded. It's not yet an entitlement, but they put I 

think $400 million into it this year. It's not yet 

an entitlement, I don't think. 

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 Silicosis was added, and this was obviously 

done by the Nevada delegation. The Administration 

did not include silicosis, but Nevada felt that the 

work that was done in digging the underground -- the 

holes, which are the equivalent of mines where the 

detonations took place, were done without the proper 

protection and people deserved to be covered, so 

silicosis was added. 

 The GDP proposal was converted and it was 

called the Special Exposure Cohort, and this is 

obviously very important for you all, the thinking 

behind this. 

 Thompson-Bingaman did a couple of things. 
27 One is while they listed the three -- the ThompsonBingaman Bill listed the three gaseous diffusion 

plants, they said there has to be a mechanism to 

expand it based -- and this was really based on the 

members of Congress hearing all over the country 

that the rad protection programs were poor, but more 

importantly that people's radiologic exposure levels 

or records were inadequate or, in some cases, 

fraudulent or lost. And we heard every sort of 

allegation you can imagine where came -- many of 

them document -- you know, people would -- brought 

in saying look, I have zeroes here while I was 

working in this place. How can that possibly be 

because there were places where things were zeroed 

out. There were all sorts of concerns and so 

Thompson-Bingaman both felt that we needed a 

mechanism -- they needed a mechanism to expand it, 

and came up with this language that you saw, which 

doesn't necessarily reflect the original 

Administration proposal which was really rather 

egregious behavior, and so that shift took place. 

And the Congressional intent around this was much 

more around if people are exposed, we can't figure 

out what they were exposed to. And there was 

certainly a lot of discussions about the fact that 

you probably can't measure some of these things 

because our records are so bad, and that's really 

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 276 where that came from. 

 Thompson-Bingaman set the benefit level at 

$200,000 plus medical, but they included the wageloss option, so you could take the $200,000 in cash 

or wage loss, but you would get medical coverage 

either way. DOL was assigned to be the lead agency 

and HHS and DOE were to assist them. 

 In the passage of that through the -- that 

was then introduced as free-standing legislation. 

It had wide bipartisan support from Ted Kennedy to 

Strom Thurmond, an equal number of Democrats and 

Republicans were on board. Originally what that 

reflected was the interest and the importance of 

this legislation locally, obviously. This wasn't of 

national concern, but in South Carolina or in Alaska 

or wherever it was, this was a very important piece 

of legislation and got very strong support from some 

key members of Congress. 

 It was introduced into the Defense 

Authorization Bill. You may recall -- well, it went 

through virtually unanimous -- this went through as 

a voice vote, and then the Bill itself was virtually 

unanimous in passage. I think it was 97 to three. 

This legislation, it's important to remember, at the 

time was seen as a compromise. There were several 

other pieces of legislation out there with also 

strong bipartisan support which were far more 
generous, and the Administration, and me in 

particular, was out there trying to limit them and 

-- it was an interesting position to be in. 

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 The Voinovich Bill essentially had that same 

benefit level, but for every occupational condition. 

 There was a similar Bill in the House that -- there 

was a Whitfield Bill, there was a Udall Bill. The 

House Bills we never focused on as much because it 

was clear the action was in the Senate, but the 

Voinovich Bill was really -- which had a number of 

these same co-sponsors, would have been much more 

costly and expansive. Marcy Kaptur from Toledo 

introduced a bill to extend the provisions of 

beryllium to the DOD, to the Department of Defense, 

which used a lot of beryllium and that caused some 

heartburn at the same time because the Department of 

Defense wasn't ready to take that step. So all 

these were going on at the same time. 

 The Thompson-Bingaman Bill became sort of 

the compromise vehicle, and the big fight was over 

whether or not to limit it to the uniquely nuclear 

exposures. And my role, among others, was to make 

sure that all these other conditions didn't get 

Federalized. And the government made a real 

commitment to making sure to take care of those 

other conditions in a way that made sense and was 

fair to workers. 
 

 The House passed their authorization act 

earlier and did not get anything -- I think it was 

earlier -- but they had a sense of the House 

Resolution saying something should be done was in 

there, but there was no actual language or any 

spending. 

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278

 It's important to remember the time that 

this took place. This was sort of the halcyon time 

of budget surplus. And while this seems like an 

expensive program, this is loose change in that 

Bill. That Bill included the expansion of tri-care, 

 essentially Medicare for life or tri-care for life 

for veterans, which I think was -- came in -- the 

first estimate was $40 billion, was the CBO estimate 

and it went up from there. 

 There was some discussion at the very 

beginning from the leadership of the Senate, which 

was Republican at the time, not to put mandatory 

spending on this. Once the House came in, and Steve 

Byar from Indiana was the -- you know, pushed for 

this tri-care for life. Once that came in, the 

floodgates were opened and this was one of the 

things that went on that. There were mandatory 

spending, which normally don't go on a Bill like 

this, but that was -- once you were maybe spending 

tens and tens of billions of dollars, what's a 

couple of billion more in putting this on. So it 
279 didn't have to go through the normal mechanisms for 

mandatory spending, which there are all sorts of 

Senate and House provisions on how you have to do 

that and you have to get various waivers, and this 

went through because these other things also went 

through at the same time. 

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 The Conference Committee -- and this was 

really one of these things where you sort of wish 

they could have done a little bit better job. There 

was a Conference Committee which negotiated this, 

and the differences between -- that were negotiated 

were not partisan differences at all between 

Democrats and Republicans. It was purely a House 

and Senate difference. The Senate had the ThompsonBingaman Bill, and that was -- they had strong 

Democrat and Republican support for that Bill. The 

House -- in this case only the House Republicans 

were involved in the negotiation -- just didn't want 

to see it, or there were few who wanted to see it, 

and wanted to limit it. And equally importantly, 

they wanted the program to look like RECA, because 

the House committee that was given jurisdiction for 

this was the Justice -- the Judiciary Committee, and 

they have RECA and they know RECA and they wanted to 

do RECA. And so you had this negotiation that took 

place without anybody from the Administration there 

because it was between, at the time, two Republican-
controlled houses and they didn't really ask our 

opinion and they didn't ask for help writing it, 

which is why we're in -- you know, some things need 

to be cleaned up because the Labor Department was 

always available to do technical draft of any issue 

people wanted on any side to make sure it's written 

well, but no one bothered asking in the conference. 

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 The dispute included the nature and the size 

of the benefit. The House wanted a RECA-type 

benefit, which is a lump sum payment without 

medical. The Thompson-Bingaman Bill was wage loss 

or lump sum, plus medical. And the compromise -- I 

think -- yeah, the compromise -- they dropped the 

wage loss provision. As a result of that, they 

didn't want to make -- it couldn't be an exclusive 

remedy. And it was very clear -- and I remember 

speaking to the staff people about this, saying you 

understand that by doing this people will be able to 

go into the state worker's compensation systems to 

get wage loss in addition to the lump sum. They 

said absolutely, that's what we want. We just 

thought that was terrible policy, but that's what -- 

you know, when you talk about Congressional intent, 

this was overt Congressional intent 'cause they 

wanted it to look like RECA. They wanted the 

Justice -- the Judiciary Committee to have 

jurisdiction. They wanted it to be a RECA program. 
 Not surprisingly, $150,000 was the compromise 

because originally we had come -- there was a 

$100,000 Bill floating around and this was $200,000. 

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 The Judiciary Committee really wanted the 

Justice Department to be lead. The Justice 

Department, needless to say, had no desire to be 

lead on this, but the Judiciary Committee wanted 

them to be lead so they would have jurisdiction, I 

think. So no lead agency -- the compromise was, 

there was no -- the President's going to do it all, 

so that led to the Executive Order of December 7th, 

needless to say because someone had to do it. 

 Again there was a compromise on silicosis. 

Some silicosis was covered, and this was the 1/1 

provisions. I don't know if you've looked at that. 

 Silicosis is -- can be diagnosed using an 

International Labor Organization scale. It's a -- 

1/0 being sort of the lowest level of overt 

silicosis, and then it goes up; 1/1 would sort of be 

mild. And so they cut the -- they drew a 

distinction between 1/0 and 1/1, which HHS at the 

time opined was ridiculous, but it didn't make a 

difference. And there was a provision that said the 

President could take it out. It would stay in 

unless the President decided to take it out. And it 

was given enough time that whoever the next 

President was would be the decision-maker on this. 
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 282 And so this is the decisions that were made. 

 The other -- the RECA survivor definition, 

even though it referred to various FECA laws, the 

way survivors were chosen to be compensated used 

some RECA definitions, which meant adult children 

would not be covered, and this caused a great deal 

of problems later on down the line and this was 

fixed in the later Defense Authorization Bill. 

 There was equity for uranium miners, which 

is something no one had ever discussed but it came 

up at the last minute because these same people who 

were giving me a lot of problems with some of the 

situations at the Judiciary Committee also felt very 

strongly if we're going to take care of the DOE 

contractor employees, uranium miners should be taken 

care of the same way. DOE was perfectly happy with 

that, as was the Justice Department, so the uranium 

miners, who originally had gotten $100,000 lump sum 

payments, now got an additional $50,000 plus 

prospective medical. They were put in the same pot. 

 It causes some confusion because you've got 

two different agencies providing benefits to the 

same people, but... There was a RECA attorney fee 

provision, but it was actually only a -- they only 

took six out of eight lines and left out a very 

important line, so that then had to be fixed later 

on, but that comes out of RECA. 
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Order in December which was also put together 

through an interagency task force, essentially 

returning to the Thompson-Bingaman model for agency 

roles and responsibilities. And while the -- so for 

example, this Advisory Committee, which is appointed 

by the President, is an Advisory Committee to HHS. 

There's no need for the President to get your advice 

on this, but HHS needs your advice. But that wasn't 

in the Bill. That's -- 

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 HHS has a very important role, and let me 

just take a moment here to talk about the phenomenal 

job I think HHS has done. I had never -- I didn't 

have any idea of who should actually do this dose 

reconstruction. Congress was the one who put in HHS 

as being the -- in charge of dose reconstruction 

rather than -- I knew DOE shouldn't do it, but I 

thought the Labor Department could find a contractor 

to do it, and Congress felt HHS should do it. And 

Congress -- the people involved in that knew NIOSH 

and they thought NIOSH could do it and I know NIOSH 

was uncomfortable, but NIOSH has done a phenomenal 

job. In my wildest imagination I couldn't have 

imagined the amount of care and thought and success 

in the two sets of regulations I've seen, the 

probability of causation and the dose 

reconstruction. It really -- it shows remarkable 
284 work and I'm grateful to NIOSH and to all of you for 

your participation in that. It's really a great 

piece of work and I know that there are people -- 

you know, they get hit from all sides. When I'm out 

in -- going out to sites, people say how come that 

dose reconstruction program hasn't started yet, or 

what's going on? And what I tell people is it may 

take a few months longer than anyone would want, but 

it's -- five years from now we're going to look back 

on this and say boy, thank God they did such a good 

job on this 'cause we won't have to redo it, and 

it's great and I think -- I'm very grateful to Larry 

and his crew for doing this. 

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 It established the interagency working 

group, which sometimes -- which sort of exists now. 

 People do get together and talk, although it 

formally says that HHS, DOL, DOE, DOJ, OMB and NEC 

are supposed to get together and talk about this 

stuff. 

 DR. MICHAELS: Well, OMB is not, that's 

right. Then needless to say, this was amended. And 

as many of you know, in the subsequent Defense 

Authorization Act, this survivor definition issue 

had to be clarified and it was easily clarified. 

 The attorney fee limit, which was 

essentially an incentive not to have reasonably -- 

reasonable attorneys get involved, was changed to 
285 actually look like RECA because by choosing only the 

lowest level from RECA but not the level of -- the 

higher amount of pay when an attorney has to do a 

lot of work would have excluded good attorneys and 

just left really bad attorneys in the system, and 

the Labor Department was certainly concerned about 

that. 

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 They changed some litigation provisions, 

which I don't need to go into, and directed NIOSH to 

study the effect of residual contamination in a 

couple of different places, and that was -- I guess 

NIOSH is doing that now. 

 So what's the lesson of this? You've all 

heard the adage, a camel is a horse designed by a 

committee. If I had found clip art with a fourhumped camel, I would have used it, but I couldn't 

find one. This Bill does not reflect 20 brilliant 

scientific policy minds coming together saying this 

is the best program. This reflects a lot of 

thinking, a tremendous amount of historical work and 

sort of saying we're not going to recreate the 

wheel. We began by saying FECA for everybody. We 

looked at the RECA program. It's pieces of programs 

that Congress had already enacted and that were 

running well, other things that were political 

compromises, some new areas that we're just trying 

out, seeing if they work. There's no one 
comprehensive cohesive vision, and I often think 

historians or journalists or anybody looking at this 

ten years from now saying well, what were they 

thinking when they put this together? Well, there 

was not any one person who thought about putting 

this together. This is a -- this Bill is a 

reflection of scientific, historic, political forces 

that all came together and this is what it left us 

to work on. And I know that sometimes causes some 

frustration, but it's what we have and that's the 

great part of the American system. 

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 So that's the history as I remember it. I 

hope that was useful. I'll take any questions you 

like now. 

 DR. ZIEMER: David, thank you very much, a 

very enlightening presentation. Let me kick off our 

question period by asking you if you can address 

this. There has been off and on concerns by -- from 

members of this Board about the language that's used 

in the original Bill expressing the, quote, intent 

of Congress. It includes -- 

 UNIDENTIFIED: The sense of Congress. 

 DR. ZIEMER: Yes, the sense of Congress. 

I'm sorry, not the intent, the sense of Congress, 

which makes certain statements about dose-effect 

relationships, about the adequacy of radiation 

protection standards and certain things like that, 
287 and maybe some are wondering how -- if you know even 

how that language arose. It looks like once this 

thing got underway, Congress took off with it. 

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 DR. MICHAELS: Yeah, that's -- I mean that 

was in Thompson-Bingaman. The Administration never 

put -- I mean our original letters that went with 

the Bills, we didn't have findings in our Bills. 

Our letters, I can certainly provide, were much more 

general, but the Congressional -- the members of 

Congress and their staffs obviously who had attended 

a lot of these meetings and who had heard from some 

of their constituents took that language because 

they felt that reflected their understanding of the 

Administration. That was not part of the original 

Administration proposal, but certainly reflected 

what some of the members who were really pushing 

this felt -- but this -- you know, it's based on 

hearing and third-hand information, obviously. But 

that's certainly how they felt. 

 But you know, findings of -- my 

understanding is findings at the beginnings of 

Bills, while they're interesting and important, they 

don't tell you what to do. It's the provisions of 

the Bill that say this is what you have to do. But 

it's important to under-- I think that reflects very 

well, though, the feeling of the members of Congress 

who put this together and their concern about this, 
28 which is why -- you know, the Labor Department had 

the Congressional briefing during the last recess, 

just to fill people -- members of Congress --or 

their staffs, obviously no members were there -- on 

where the program is. And more than 40 offices sent 

people. We were shocked. The interest level's that 

high because these are important issues back home. 

People are getting money or not getting money and 

there's long concern, there's press interest and so 

that interest remains there. 

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 DR. ZIEMER: I'd ask for other questions or 

comments. Yes, Roy DeHart. 

 DR. DEHART: I was surprised to see a legal 

fee imposed there. I don't see this like a worker 

compensation system where representation's required. 

 DR. MICHAELS: You mean the attorney fee? 

 DR. DEHART: Yes. 

 DR. MICHAELS: Well, the way the attorney 

fee provision -- the original Administration 

proposal did not have that fee in it at all. RECA 

has a -- RECA acts -- is set up like a tort system 

in that an attorney gets a percentage of the 

settlement and they get up to -- the way RECA's 

written, the -- RECA was amended just before this 

Bill came to the floor, a few months before, and 

there was -- actually the only fight they had over 

the amendment was around the attorney fees, and the 
289 RECA provisions are the attorney gets three percent 

of the settlement -- two percent of the settlement 

and they get ten percent if there's an appeal and 

there's real -- there's more work about it. The 

first -- the initial filing is not a lot of work so 

that's only two percent. This Bill took just the 

two percent. And it sort of works on the lump sum 

provision. It says you can -- since everyone's 

getting $150,000 and no wage loss, it's reasonable 

to take a percentage of it to an attorney. 

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 At the Labor Department there was some 

difficulties in figuring out did they mean to apply 

this to medical costs, because some state worker's 

compensation systems, lawyers are actually paid a 

percentage of the medical costs and that would not 

work in this case, so that's one of the reasons 

we're very happy that it was amended the second time 

to make it clear that the percentage only comes off 

of the lump sum. And if an attorney really has to 

do some work and get involved in appeals, they 

should get a larger percentage because that will 

require some work. And the feeling from the Labor 

Department, as well as many people, is that if it's 

limited to two percent, you're not going to get a 

good attorney willing to take it on. You'll get 

people who just do sort of millwork and -- to the 

detriment of the system and to the workers involved. 
29 But that provision -- but worker's comp provision 

wouldn't look like that, but this isn't a worker's 

comp bill. I mean it's a -- it's neither fish nor 

fowl. That was the -- this compromise. 

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 DR. DEHART: It just appeared, as we've gone 

through this, that everything is being done for the 

benefit of the claimant -- to get a filing and 

everything -- without having to go through an 

attorney at all. 

 DR. MICHAELS: That was the basis -- that 

was -- the basic idea from the Labor Department is 

we'll set this up, and Labor really pushed this from 

the beginning, we don't need attorneys in the 

system. But once it became a RECA system, then we 

took the RECA provisions and that's one of these 

strange things. It's unfortunate 'cause it's not a 

cohesive system with a philosophy behind it. It's a 

schizophrenic system. 

 DR. MELIUS: What about the fee for the 

Advisory Board, that's far more important. 

 DR. MICHAELS: Exactly. 

 DR. MELIUS: The Special Exposure Cohort, 

could you speak to that? There's really sort of two 

criteria that are included in there. I'll quote, 

(Reading) Not feasible to estimate with sufficient 

accuracy the radiation dose that the class received 

and reasonable likelihood that such radiation dose 
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 291 may have endangered the health of... 

 Can you speak to how that language came 

about? 

 DR. MICHAELS: Yeah, I think what that 

reflects -- I think it's poorly crafted, but I think 

they were just -- this was the first time out. And 

you know, many pieces of legislation get multiple 

shots at being passed and get perfected before 

they're passed. This was one time around. I think 

the basic idea here was that -- and certainly 

hearing this from Senator Bingaman's staff -- they 

had heard, as many of the members had heard, of 

people coming forward saying I don't believe my dose 

records; they're wrong. They can't -- they can't be 

measuring right because I know what I was exposed 

to. And I believe in many cases that people were 

lying to me. And so I think the Congressional 

people took sort of our GDP concept and said well, 

this should be in that same -- if people are exposed 

and they weren't even keeping records or keeping 

good records, people should be allowed to get 

compensated, but we don't want to compensate the guy 

who walks in who's just -- was just refilling the 

Coke machine. So how do you -- how do you draw the 

line? And of course they didn't have any idea, and 

I don't have any idea, either. I don't mean to 

criticize them. I don't think I would do it any 
292 better. -- on how do you figure out if someone was 

exposed, but -- you know, that -- the rad 

protections in Paducah, the dose records weren't 

done right. And so that's essentially -- they did 

it as well as they could and they threw it on you to 

figure it out. That's why you're paid the big money 

here to do it. 

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 DR. ZIEMER: Other comments? Oh, I'm sorry 

-- Wanda? 

 MS. MUNN: Dr. Michaels, I have to thank you 

for a fascinating presentation. For those of us who 

live out in the boonies, the way things work inside 

the beltway is an absolute astonishment, so just 

following that was an exercise in concentration, 

believe me. 

 I'd like to go back to what was touched on 

earlier with respect to the sense of Congress 

statement. The thing that is of concern there is 

even though it is not a part of the Bill, when a 

statement is made that is so extremely misleading 

that any non-political person just reading it as a 

casual observer would be misled, it's kind of a 

problem for those of us who like to believe that 

Congress is capable of doing better than that. I 

refer specifically to item number six in the Bill. 

It has only two sentences in it, and the two 

sentences are simple. The first one is very 
2 straightforward, (Reading) While linking exposure 

with the development of occupational disease is 

sometimes difficult, scientific evidence supports 

the conclusion that occupational exposure to dust 

particles or vapor of beryllium can cause beryllium 

sensitivity and chronic beryllium disease. 

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 I think everybody recognizes that. There 

isn't much conflict around that statement. 

 The second sentence says (Reading) 

Furthermore, studies indicate that 98 percent of 

radiation-induced cancers within the nuclear weapons 

complex have occurred at dose levels below existing 

maximum safe thresholds. 

 UNIDENTIFIED: Ninety percent, well -- 

 MS. MUNN: (Reading) Ninety-eight percent of 

radiation-induced cancers within the nuclear weapons 

complex have occurred at dose levels below existing 

maximum safe thresholds. 

 Now the first time I read that, my first -- 

I got through the first three words and thought what 

studies? I've never seen any studies like that. 

And after I'd read the sentence three times, I 

realized that this statement can probably be made 

about the general population. Why radiation-induced 

cancers, assuming that they are the radiogenic 

cancers that are identified elsewhere, is what 

they're talking about. If you make that assumption, 
294 then this probably can be made clear of anyone who's 

walking around. But the casual reader would take 

that to mean my word, 98 percent of all radiogenic 

cancers have occurred in our workers who were unduly 

exposed because of inadequate regulation, and that's 

-- that's the sort of misleading and almost 

outrageous statement that does nothing for either 

helping come to good conclusions in dose 

reconstructions or helping sure -- making sure that 

people who should be compensated are compensated. 

It simply muddies the water and if that is in fact 

the sense of Congress, I'm assuming that it's the 

sense of some staffer who works for someone in 

Congress, but if that -- since it goes in -- to a 

specific part of our national law, it becomes more 

than just a simple -- a casual mis-statement made by 

someone in addressing this issue. 

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 I guess I'm a little curious -- 

 DR. MICHAELS: Well, it's worth thinking 

about that. I mean I can only respond -- I think I 

have two different responses. One is, given my 

understanding of the exposures -- you know, most 

workers in the DOE complex were not exposed to 

anywhere near the radiologic limits. 

 MS. MUNN: No. 

 DR. MICHAELS: Correctly. In fact, and if 

we believe through the (inaudible) threshold, it may 
actually be true that 98 percent of radiogenic 

cancers, even though they may not be identifiable, 

in fact are caused by exposures below the limit 

because we have a large -- hundreds of thousands of 

people exposed to relatively low does. But that 

aside, putting aside accuracy to talk about process, 

in putting together this proposal -- this 

presentation, I went through hundreds of pages -- 

mostly not very interesting ones -- of the 

interagency review of the Thompson-Bingaman Bill 

because three times a week there would be something 

that would go around, and for some reason I saved a 

lot of them, with commenting on different lines and 

the -- you know, Labor Department would say this and 

then HHS would say that. And I mean everybody here 

saw those, and in not one of them did we ever 

discuss the findings, the sense of Congress at the 

beginning. They were totally ignored. And we 

looked at that Bill -- you know, no one cared about 

them. 

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 Now maybe it's a problem that you think 

people are reading them, but in fact -- I mean the 

sense of the Administration is no one cared what was 

in there. If Congress wanted to say that, that was 

fine, but what we cared about was what they were 

telling us to do. And so there was no comment on 

any of that. And I couldn't even tell you what was 
2 in there. I mean I'm glad you read it to me, but 

that's -- you know, I don't know if that's a -- what 

that means, but that we just ignored that. 

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 DR. ZIEMER: And part of the concern here is 

that it is claimed to be based on scientific 

studies -- 

 MS. MUNN: Yes. 

 DR. ZIEMER: -- and I don't know of anyone 

who's aware of any such studies that would make such 

a claim. Richard Miller says that he has some 

information on that statement. Richard -- 

 MR. MILLER: Sure, I'd be -- 

 DR. ZIEMER: -- can you add to that? 

 MR. MILLER: -- glad to. And by the way, 

Ms. Munn, you are right. There was a Congressional 

staffer involved in it and for -- as Dr. Michaels 

properly reported, neither the Administration nor 

the public had any role in the conferencing process. 

 We were -- it wasn't even a fishbowl where you got 

to look in the windows and see what was going on. 

We'd occasionally get FAXed pieces of pages of a 

draft with talking points. So when the things like 

finding came out, what the Thompson-Bingaman Bill 

initially had in it and what was finally reported, 

as you just read it, are very different. And in 

fact, some of us have -- who have thought about 

doing some amendments have thought about a technical 
correction to precisely to that very clause, and 

maybe I can illuminate because I agree with you, 

there's some concern about that finding. 

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 What happened was, when Bob Nordhouse was 

the general counsel for the Department of Energy and 

Tara O'Toole, the successor to Dr. Ziemer, was the 

Assistant Secretary, they commissioned some folks at 

MIT led by Nick Ashford to undertake a study of the 

DOE worker compensation system. So some of the 

thinking that's leading to this had been going on 

well before Bill Richardson's tenure. And in the 

study -- and I can't -- I don't have the exact title 

of it, but it's -- oh, I don't know, about a foot 

thick, which looked at both the epidemiology that 

had been done in the DOE complex, had looked at the 

experience of the worker compensation system. One 

of the conclusions that they drew was with respect 

to what's called the doubling dose. And the 

question was, what is the likelihood, based on the 

epidemiology that had been done in the DOE complex, 

that individuals who sought compensation for 

radiogenic cancer -- or cancers arising out of the 

course of employment from exposure to radiation more 

broadly, what was the likelihood that they were 

going to be able to meet the doubling dose 

criterion. In other words, how many of those 

cancers would actually fall over the doubling dose. 
 And what the report said -- and it's a public 

document and so -- as a matter of fact, if you'd 

like, I'll get a copy of it and give it to the 

committee -- 

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 DR. MICHAELS: It's on the web site. 

 MR. MILLER: It's on your web site? Okay. 

And what that report said, and others who have read 

it should correct me if I inaccurately state this, 

but I think it's right, was that with respect to the 

doubling dose somewhere between one and two percent, 

depending on whether it was cancer death or cancer 

incidence, will fall above the doubling dose level. 

 In other words, individuals who received in excess 

of two percent, and so therefore, inversely, 98 

percent of all occupationally-related cancers which 

-- do you follow me? Okay. Ninety-eight percent of 

all occupational cancers will fall below the 

doubling dose, below the doubling dose -- okay? -- 

which is the legal standard of causation under most 

state worker's compensation programs. And if you 

look at the Thompson-Bingaman Bill, it specifically 

-- and I will get you actually the Thompson-Bingaman 

as it was added to the Senate Defense Authorization 

Act -- you will see specifically that's how it's 

quoted. All right? That it falls below the legal 

threshold for causation under compensation systems. 

 It had nothing to do with the safe threshold. 
 299 So when this thing came out of conference -- 

okay? Need I say more? -- it -- whoever was 

involved at the staff level had never bothered to 

pick up the phone to say what was intended by this? 

 And people were much more engaged in the fight over 

the silicosis standard, over which agency was going 

to be implementing this program -- Do you see what 

I'm saying? -- and we were all much more bogged down 

on the outside about that, and we never even looked 

at revised findings. And so I can't imagine what -- 

I don't know whether it happened on the Judiciary 

Committee, whether it happened in the Labor 

Committee, whether Speaker Hastert's office, who was 

involved in drafting this, did it. I have no idea, 

'cause the Senate staff sure knew exactly what this 

was about 'cause everybody had seen this Ashford 

study. So it has to do with the doubling dose. It 

has nothing to do -- and your concerns are entirely 

proper, and there is a study to back that up. 

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 DR. ZIEMER: Thank you for that 

clarification and -- 

 MS. MUNN: Yes. 

 DR. ZIEMER: -- although it's quite true 

that the sense of Congress stuff is not the law, per 

se, the concerns I think that Wanda has raised are 

certainly real in terms of what this says to the 

public. And it may be at some future point that 
300 this Board may in fact wish to comment on that. In 

one way it's sort of outside what our immediate 

responsibilities are, but on the other hand, it's a 

concern that could be in some way probably 

appropriately raised as a concern on what it says to 

the public in trying to properly educate people 

about all of the issues surrounding not only this 

compensation program but other aspects of radiation 

effects and health effects and so on. 

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 MR. MILLER: Excuse me, Dr. Ziemer -- 

 DR. ZIEMER: I want to thank Wanda for 

raising that. 

 MR. MILLER: And if you'd like, I'd be 

pleased because we have some language right now 

that's been prepared to amend that particular 

finding that we've sent up to the Hill to alleged 

counsel to have prepared, and we'd welcome your 

commentary on that language because it has not 

escaped our attention, either. It is a commonlyshared concern. 

 DR. ZIEMER: Okay, thank you. 

 MS. MUNN: And I guess I would like to also 

comment that not only is there great concern from my 

quarter with respect to what this says to the 

public, there is also great concern with respect to 

what this says about Congress and its sense about 

what we're looking at, so thank you. 
 DR. ZIEMER: 301 Do we have additional questions 

for Dr. Michaels? Yes, Roy, and then Jim. 

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 DR. DEHART: If we could return to the 

Special Cohort, the enthusiasm that you described 

that was occurring, or certainly a bandwagon of 

support across the country, as the activities of 

this committee and the review of complainants or 

claimants for awards occur, some will not receive 

benefit. They will fall under the criteria. There 

will be a lot of questions raised by claimants about 

the accuracy of dose, regardless of the science that 

goes into that. Where do you see the Special Cohort 

concept going? Is it going to be a bandwagon in 

itself, because there's already letters to Congress 

-- or from Congress to the Administration regarding 

this. 

 DR. MICHAELS: I don't know. I mean I'm 

quite confident that if someone has a reasonably 

good dose record or -- I'm quite confident that the 

dose reconstruction probability of causation modules 

that Congress and the Administration originally came 

up with and have been developed and perfected and 

hopefully implemented soon by NIOSH, if explained 

properly to workers, will show that even if there 

are inaccuracies in their individual dose, if 

they're close to being compensated, they're going to 

be compensated because it -- you have a 99 percent 
302 confidence interval. I mean it's really set up in a 

way that ought to cover those people, and that's the 

idea. 

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 Are there whole populations, though, which 

-- where there were overt activities and egregious 

overt activities of exposure and lack of recordkeeping, they would sort of fit into the Special -- 

and we -- you know, take them a case at a time. We 

don't know. And I don't know how NIOSH is going to 

rule on that or how they're going to think about it, 

but to me, that's -- those would be the ones to 

think about. It's not the ones where just -- you 

know, there are no records, because I think it's 

reasonable to think you could figure out what people 

-- you know, the more -- the ball park. It's where 

you have these situations which people just didn't 

care, didn't control, didn't make -- didn't sort of 

protect people should be the ones that sort of get 

more scrutiny. I don't know. I mean I haven't 

followed it too carefully since then. I'm actually 

trying to get out of this and do some other things 

-- trying to get a new job. 

 DR. MELIUS: Along this same line, though, 

in terms of -- we're not out of it, so we've got to 

keep -- we're trying to keep you in it so that we -- 

at least to get some information and help. This 

issue of reasonable likelihood that radiation dose 
303 may have endangered, was there any thinking in terms 

of -- a certain criteria in terms -- such as an 

epidemiological study or anything like that -- 

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 DR. MICHAELS: I don't think there was. I 

think they really felt like -- and the staffers who 

wrote this I think were very -- were not the ones 

who said let's just write something down. They 

really thought about this a little bit and said this 

is the best we can do at this hour, and we know 

there are good people in the government who could 

figure this out. I mean I think -- I believe that's 

what they really felt. And it's nice to see you all 

today. 

 DR. ZIEMER: Further questions? 

 (Pause) 

 DR. ZIEMER: Dr. Michaels, thank you again 

for sharing with us today. It's been very helpful. 

 DR. MICHAELS: Thank you all. 

 DR. ZIEMER: We're now going to move to the 

public comment period. We have one individual who 

has requested time to make comments, Robert Taber. 

Robert, are you here? Please. 

 MR. TABER: Yes, I am. I'm here. I'm Bob 

Taber. I attended this session back in January. I 

worked at the Fernald facility and my background 

basically is I'm a millwright by trade and I've been 

employed there since 1981, and I'm happy to see that 
304 the citizens of the United States and our government 

is finally addressing some of the things that should 

be addressed. 

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 I want to be somewhat philosophical here 

just for a moment and say that I'd like to remind 

everybody that doing the right thing right the first 

time is really an opportunity. And what I mean by 

that -- and I say that a lot to workers and I say 

that a lot to management because we can do the right 

thing right, we can do the wrong thing right, we can 

do the right thing wrong, or you can do the right 

thing right. And if you want to drive a little 

efficiency into it, maybe try to do it the first 

time around. Of course that's not the normal way we 

do business it seems like a lot of times in the 

world that we live in. 

 With that in mind, I would -- I have written 

down some thoughts that I had. Mostly I like to 

speak from an impromptu perspective, but I think 

this is worthwhile reading and eventually I will get 

to my specific point. I had some thoughts and what 

I wrote here was I would like to encourage this 

Advisory Board to stay focused, to not forget the 

intent of the Act; to remember that like many 

Americans who gave their lives in combat in the name 

of freedom, that many Americans, the Cold War 

veterans, sacrificed much to maintain that freedom. 
 Many Cold War veterans have died and others are 

inflicted with illnesses due to the work-related 

environment. The people of this nation, as well as 

our government, have a responsibility to make things 

right. This law, this Act is just one effort to 

meet that responsibility. To do anything less than 

the right thing right, hopefully the first time, is, 

in my mind, unacceptable. 

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 305

 Now let me be a little bit more specific. I 

would say that therefore -- you know, I would 

challenge you to see that the program is properly 

structured, specifically with respect to the 

evaluation criteria for dose reconstruction in order 

that these cases be fairly adjudicated. I guess 

what I have in mind to say there is that it appears 

to me that maybe -- I don't have the scientific mind 

that you folks do, but I get the inclination that 

maybe we might not be comparing apples to apples and 

oranges to oranges when it comes to the criteria for 

developing this dose reconstruction. 

 When I was listening to -- his name doesn't 

come to mind right now, from the NIC -- I mean 

NCI -- 

 UNIDENTIFIED: Dr. Land. 

 MR. TABER: Dr. Land, thank you. And when I 

think about all the various types of worker studies 

that are out there, I'm not so sure that the kind of 
statistics that we've accumulated in the past, 

especially to gain some insight as to how the 

worker's impacted by the environment that he works 

in, that the things that we have accumulated from 

maybe Japanese folks who survived the Nagasaki and 

Hiroshima bombs and the studies that we've done on 

those folks -- I mean, you know, in my mind, common 

sense tells me that the strong survive and the weak 

perish. And if you're only doing studies on those 

who survived, you're doing studies on those who were 

strong enough to survive. And I can't exactly say 

that I would think that those particular types of 

studies on those people would necessarily compare to 

what a worker in the nuclear network has seen over 

the years. 

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 I can recall the day and age when I went to 

work in 1981, I was one of the fortunate type that 

went to work later on in my life, and respiratory 

equipment and PPE at that time was not mandatory -- 

at least not at my site, but it shortly became a way 

of doing business. Some folks, it was an optional 

thing, and some of us would go ahead and say hey, 

it's a good idea to put on a half-mask, good idea to 

put on a respirator. I can remember when many a 

times that you would go to the showers in the 

afternoon and your white uniform would be totally 

green. There was no white showing. And my arms 
307 were covered with green salt that were soaking into 

the pores, you know, from where you had sweat and 

you could see this stuff caked on you. And it was 

common to see black oxide all over the place. Many 

a times I have serviced a reactor -- not that kind 

that you have to stay away from, so to speak, like 

plutonium, but a reactor in making feed material 

that would be going out to Hanford and down to 

Savannah River. Then you would have to maybe do a 

fix on that particular reactor and we would open up 

that vessel and it would just burst black oxide out 

and people would stand there and poke away to try to 

un-jam it. And they're inhaling these type of 

things. Now just think about doing that for years. 

 And this is before we used the kind of science that 

we have now to monitor people. And I guess that's 

why probably you have some of this Special Cohort 

groups because there's no way of saying that these 

people were not inflicted by that. 

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 But I have seen many of my fellow workers 

die in the past years. I've been there just 21 

years May the 11th, in fact, and I know that what 

we're doing now is really important. So I would 

really encourage you folks to take advantage of the 

opportunity that if this program has any holes in 

it, that we're not comparing apples to apples and 

that we're not comparing oranges to oranges, that we 
308 take this opportunity to take and make things right 

and that we do it right the first time. What you 

don't want to have happen -- and you don't see a lot 

of people like myself who have the interest in 

seeing that justice is done in behalf of our 

workers. These folks don't understand the same 

things that you understand, but after a while 

they'll begin to understand that. If they suspect 

that we haven't done the very best job that we have 

the opportunity to do, let me tell you, you will 

hear those outcries later on. And they will get 

their representatives and those folks involved. So 

while we have the opportunity to do this thing 

right, I want to encourage all of us to take that 

opportunity. And if there's some holes that need to 

be plugged, especially in this area of the SEC and 

especially in this area of the criteria for which to 

maybe do these evaluations to the best of our 

ability. And I do compliment the work that NIOSH 

has been doing and I compliment the work that you 

folks do as well. I'm just suggesting that it 

doesn't appear that it's a perfect world and that we 

can make it better and that there's some opportunity 

here and I would like to see us take that 

opportunity. 

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 And I think with that -- oh, there was one 

other item I had on my mind that I wanted to remind 
309 us of. Last time I was here I said something to the 

effect about record-keeping. Lookit, folks, a lot 

of these sites out here, especially that of Fernald, 

are closure sites. They have lifted the moratorium 

on records. Now I know medical records are required 

to be held, but there's a lot of historical 

knowledge that will be probably utilized in maybe 

making some determinations about these cases. If 

you folks haven't stepped up to the plate and spoke 

up to whoever it is we need to reach out and get 

that message to about record retention, let's not 

forget that. Closure is right around the corner and 

some of this stuff is going to get archived, if not 

disappear. It may be very, very pertinent to seeing 

that there's some justice for some specific 

individual cases, simply because we overlooked the 

fact of sending the message -- hey, hang onto some 

of this stuff. 

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 I can't think if there was anything else 

other than that. 

 I have a big interest in the Special 

Exposure Cohort, I guess because Fernald is not in 

that. I don't quite understand why not, but I'm not 

going to go into that at this time. I guess I'll 

just kind of track that as things go along and hope 

to see you sometime in the future. Thank you. 

 DR. ZIEMER: Thank you, Mr. Taber, and that 
certainly is a good challenge to all of us to -- 

both on the Board and staff people, to do our best 

to do things right. 

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 310

 Now let me ask if there are any other items 

to come before us today before we adjourn. Yes, 

Jim? 

 DR. MELIUS: I have one little follow-up to 

what Mr. Taber said. In actually reading the 

legislation, we are mandated in the legislation to 

review the quality of the dose reconstruction 

efforts and I think we -- it's really imperative at 

that next meeting, presumably in early July, that we 

develop a plan and action to go forward on that 

'cause I -- it is going to take some time. It's not 

something we can sit in a meeting and do, I don't 

think, and so I really urge that we make sure that's 

on the agenda for next time and that we leave time 

to discuss and develop that plan. 

 DR. ZIEMER: Thank you, Jim. And not only 

will that be on the agenda, but I'd like to ask 

Board members individually between now and then to 

think about those issues in terms of what might be a 

practical scheme to -- for us to carry out our role. 

 And that means, for example, how do we want to 

evaluate the datasets that are being looked at? How 

do we wish to review the process itself, the 

mechanical process of dose reconstruction and any 
311 related -- and how much of the actual caseload do we 

wish to review? So there are a number of questions 

that we have to ask and then think about ways that 

we can carry that out. 

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 I was thinking last night a bit on just the 

datasets, and I know the staff has given a lot of 

thought -- it's not only getting the data, but 

saying how good is the data and is there enough of 

it. And I think we want to get some feel, for 

example, for what that looks like ourselves, and not 

just be looking at sort of well, how do the final 

calculations look but delve back in here and there. 

 But those are some issues that I think it will be 

worth all of us giving thought to between now and 

the next meeting so that when we come together to 

discuss this, we might have some creative ideas that 

could be brought to the floor as to how we might 

proceed. 

 DR. MELIUS: Would it be appropriate to have 

a subcommittee that would at least maybe do a 

conference call or something in between now and the 

next meeting to discuss or come up with some ideas, 

hopefully? 

 DR. ZIEMER: I'm certainly open to that. 

I'm never quite sure exactly what we can do in terms 

of formal activities that don't involve -- you know, 

can we do conference calls and e-mails and so on or 
31 do all of these have to be out on the web site and 

so on. I mean not that we shouldn't do that, but 

there's an efficiency factor, too. Maybe Jim -- or 

Larry or somebody could help us on how we might be 

able to do some of this between now and then and 

have a group do a little sidebar brainstorming and 

come up with a straw man approach that might be 

used. 

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 MR. ELLIOTT: You can certainly have a 

working group established to meet by teleconference 

and exchange e-mails. We'll put those e-mails on 

the web sites so that all the members of the 

committee and the public can have access to them. 

We can set that up. A subcommittee is -- 

 DR. ZIEMER: As opposed to a working group? 

 MR. ELLIOTT: Yeah, a subcommittee has a 

distinct function and life cycle and a working group 

can go on and on and on here, so... 

 DR. ZIEMER: A subcommittee is more of an ad 

hoc committee. Well, and certainly -- 

 DR. MELIUS: No, there's nothing really -- I 

think it is the other way. I'd shared some other 

boards and I think it's the other -- 

 DR. ZIEMER: It's the other way around. 

 DR. MELIUS: A subcommittee is a formal -- 

 DR. ZIEMER: Then the working group is more 

correct, okay. 
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 DR. MELIUS: 313 For us, working group would be 

-- 

 DR. ZIEMER: Whatever it is we're talking 

about, we know what it is. Right? 

 Well, let me ask if there are those on the 

group that would be willing to participate in such 

an activity between now and our proposed meeting. 

Okay, Henry's volunteering, Roy is volunteering, 

Sally's volunteering, Gen's volunteering, Mark's 

volunteering, Tony -- we almost have the full group. 

 Okay, and Richard's volunteering. 

 Well, that's a good-sized subcommittee. 

It's everybody but the Chairman. We would need 

somebody to be willing to sort of have the lead on 

it. Who are you pointing at? Jim. 

 DR. MELIUS: I didn't volunteer. 

 DR. ZIEMER: He hasn't volunteered. Mark, 

do you want to -- 

 UNIDENTIFIED: All right, I'll take it. 

 DR. ZIEMER: This is just for -- just to 

have a point of contact, so Mark, if you will take 

the lead and you have the names of everybody who 

volunteered. Please keep me in the loop on all of 

your ideas. 

 DR. ANDERSON: Just -- this is one kind of 

informational point. If we're going to be doing 

specific case reviews, the issue of confidentiality 
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 314 -- 

 MR. ELLIOTT: You won't see the individual's 

 name. There will not be personal identifiable 

information in these. 

 DR. ZIEMER: If we end up looking at data -- 

 MR. ELLIOTT: It would be de-identified. 

 DR. ANDERSON: Yeah. What we need to know 

is what constitutes -- I mean you can't -- there 

will be very specifics in the work history and the 

age -- 

 DR. ZIEMER: Right, right. 

 DR. ANDERSON: -- in the site that -- you 

know, you just need to -- 

 MR. ELLIOTT: We understand that very 

clearly. 

 DR. ANDERSON: Yes. 

 MR. ELLIOTT: We have to protect -- it's our 

responsibility to protect the confidential -- 

 DR. ANDERSON: Yeah, the issue I was going 

to raise is since we're tasked to do that, there 

would be some role and we are government employees 

as -- 

 MR. ELLIOTT: That's right. 

 DR. ANDERSON: -- but what I'm trying to say 

is one option would be to have the specific reviews 

and the cases we choose reviewed in a non-open 

forum. The results of the review and our 
315 compilation of that would be done in a public forum, 

so -- 

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 DR. ZIEMER: Well, this is one of the items 

that you can consider as you -- let's not solve the 

problem -- 

 DR. ANDERSON: It really becomes a NIOSH 

decision -- 

 DR. ZIEMER: Right. 

 DR. ANDERSON: -- but it would seem to me 

that we could -- 

 DR. ZIEMER: We can propose some ideas along 

those lines as a part of this exercise. 

 MR. ELLIOTT: Let me take you back just a 

second. Given that everybody, minus the Chair, is 

on this thing, it would have to be a subcommittee. 

And a subcommittee -- when you meet as a 

subcommittee you have to have the -- we'll announce 

it and public availability will have to be made. If 

you're a working group, we do not -- we would 

announce the working group, but we don't have to 

accommodate public participation. Just so you're 

clear on that. 

 DR. ZIEMER: Yeah, I think we decided that 

this was going to be a working group. It's ad hoc. 

 It doesn't go on forever. It's for a specific 

purpose. 

 MR. ELLIOTT: The issue is is a working 
316 group needs to be limited in number. If you have -- 

you're achieving a quorum here, and then you've got 

a subcommittee. 

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 DR. ZIEMER: Let's do just that then, make 

sure we have not exceed the quorum, number one -- 

 MR. ELLIOTT: I don't have a problem either 

way. 

 DR. ZIEMER: -- and other folks can be kept 

in the loop as far as information is concerned. 

Let's see again who was -- okay, Mark, Gen, Roy, 

Robert, Richard, Sally and Henry. Okay, now we're 

over the quorum so let's -- 

 DR. ANDERSON: I guess what I -- I would 

like to see what's going on. I'd be happy to 

comment, but I don't necessar-- I mean if we want to 

cut down the numbers, I don't need to be officially 

on the work group, as long as everybody is in the 

loop and can comment. 

 MR. ELLIOTT: The other members -- 

 DR. ANDERSON: But we charge the work group 

to do the compilation and keep the record, that -- 

 MR. ELLIOTT: Members of the Board would be 

fully kept informed, no matter which way you go. 

 DR. ANDERSON: If I drop out you'll be at 

five, so you won't have a quorum, so that may be -- 

 MR. ELLIOTT: That's six. 

 DR. ZIEMER: We're still at six. 
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 MS. GADOLA: 317 I can drop out. 

 DR. ZIEMER: Sally's dropped out, but again, 

you'll be in the loop and -- okay, one, two, three, 

four, five. 

 MR. ELLIOTT: So for the record, we need to 

establish who is on this and -- 

 DR. ZIEMER: Okay. Mark Griffon will chair 

the work group, will include Genevieve Roessler, 

Rich Espinosa -- Roy, were you -- yeah, Roy DeHart, 

I think Robert and that's it. Right? One, two, 

three, four, five. Okay? 

 MR. GRIFFON: The only thing is, Tony didn't 

have the opportunity here. He might be interested 

in this topic, so I don't know -- 

 DR. ZIEMER: And again, Tony will be in the 

loop and will have opportunity to comment if 

necessary, so -- I mean he didn't have an 

opportunity, but I don't think it's appropriate for 

us to volunteer for him at this point, so -- 

 MR. ELLIOTT: And point of order for the 

record, we need to establish the charge to this 

working group. 

 DR. ZIEMER: Okay. 

 MR. ELLIOTT: Clearly. 

 DR. ZIEMER: The charge for the working 

group -- let me put some words out here and see if 

this sounds okay. The charge to the working group 
318 would be to develop an initial draft of the process 

for this Board's meeting its obligation to -- now I 

want the words that are in our charge -- 

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 DR. MELIUS: Can I -- in the legislation 

it's (Reading) review the quality of dose estimation 

and reconstruction efforts. 

 DR. ZIEMER: Right, that's what -- the words 

we're looking for. 

 DR. MELIUS: Can we say have -- rather than 

-- why don't we have -- develop a draft, why don't 

we have develop options. 

 DR. ZIEMER: Yes, that's fine. 

 DR. MELIUS: I think that -- 

 DR. ZIEMER: Develop options for how we 

would meet that requirement. Is that specific 

enough for -- from a legal point of view? Do y'all 

understand the charge? Mark, do you have that? 

 DR. MELIUS: And then to report back to us 

at our next meeting. 

 DR. ZIEMER: To report back at our -- 

 DR. MELIUS: At our next meeting and then -- 

 DR. ZIEMER: And to keep us informed as you 

proceed. And there are some specific words in the 

Act that pertain to what this Board has to do on 

that process -- assess the methods established and 

verify a reasonable sample of the doses established. 

 So it's in that context. Thank you. 
 319 Now let me ask, is there further business to 

come before the Board at this time? 

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 (Pause) 

 DR. ZIEMER: Staff, any additional 

housekeeping things we need to take care of before 

we leave? 

 MR. ELLIOTT: Just remember to turn in your 

sheets to me on your preparation time, and if you 

haven't turned in your -- and you want to, your 

photo release form, and I thank you again for all 

your participation and your effort in the meeting. 

 DR. ZIEMER: Yes, and let me echo that. 

Thanks to everyone for a productive time together. 

We look forward to our next meeting, probably on the 

dates indicated, perhaps in Denver. We'll see where 

we end up. Thank you very much. We are adjourned. 

(Meeting adjourned at 11:30 a.m.) 
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C E R T I F I C A T E 320

STATE OF GEORGIA :

 :

COUNTY OF FULTON :

 I, Steven Ray Green, Certified Merit Court 

Reporter, do hereby certify that I reported the 

above and foregoing on the 2nd and 3rd day of May, 

2002; and it is a true and accurate transcript of 

the proceedings captioned herein. 

 I further certify that I am neither kin nor 

counsel to any of the parties herein, nor have any 

interest in the cause named herein. 

 WITNESS my hand and official seal this the 

4th day of June, 2002. 

 

 

___________________________ 

 STEVEN RAY GREEN, 

CERTIFIED MERIT COURT REPORTER 

CERTIFICATE NUMBER: A-2102