THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

PUBLIC HEALTH SERVICE
 

CENTERS FOR DISEASE CONTROL AND PREVENTION
 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
 

convenes the
 

ADVISORY BOARD ON
 

RADIATION AND WORKER HEALTH
 

VOLUME II
 

The verbatim transcript of the Meeting of the
 

Advisory Board on Radiation and Worker Health held
 

at the Holiday Inn on the Hill, Washington, D.C.,
 

on Wednesday, January 23, 2002.
 

NANCY LEE & ASSOCIATES 

Certified Verbatim Reporters
 

P. O. Box 451196
 

Atlanta, Georgia 31145-9196
 

(404) 315-8305
 
2 

 

 

C O N T E N T S
 

VOLUME II
 

January 23, 2002
 

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

ADMINISTRATIVE ORIENTATION
 

Ms. Corrine Homer .................. 8
 

BOARD WORK SCHEDULE
 

Mr. Larry Elliott .................. 15
 

WORKING SESSION ON PROBABILITY OF CAUSATION 


COMMENTS ........................ 36
 

Motion and Vote ................. 40, 41
 

Motion and Vote ................ 102, 109
 

PUBLIC COMMENT PERIOD
 

Mr. Robert Tabor .................. 128
 

Ms. Fay Martin ................... 137
 

Mr. David Richardson ................ 139
 

Mr. Roger Shaw ................... 147
 

Mr. Jim Ellenberger ................ 151
 

CONTINUED WORKING SESSION ON PROBABILITY OF 


CAUSATION COMMENTS .................. 155
 

Motion and Vote ................ 157, 162
 

DOSE RECONSTRUCTION RULE 42 CFR PART 82
 

Technical Guidelines for External Dose 


Reconstruction and Internal Dose Reconstruction 


Dr. James Neton ................. 187
 

CLOSING COMMENTS/ADJOURN


Dr. Paul Ziemer .................. 260
 

CERTIFICATE OF REPORTER ................ 265
 

Legend of the Transcript:
 

(phonetic) = Exact spelling unknown


— = Break in speech continuity


(sic) = Exactly as spoken
 
3 

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

(By Group, in Alphabetical Order)
 

ADVISORY BOARD MEMBERS
 

CHAIR
 

PAUL L. ZIEMER, Ph.D.


Professor Emeritus
 

School of Health Sciences
 

Purdue University


Lafayette, Indiana
 

EXECUTIVE SECRETARY
 

LARRY J. ELLIOTT
 

Director, Office of Compensation Analysis and Support


National Institute for Occupational Safety and Health


Centers for Disease Control & Prevention
 

Cincinnati, Ohio
 

MEMBERSHIP
 

HENRY A. ANDERSON, M.D.


Chief Medical Officer
 

Occupational and Environmental Health


Wisconsin Division of Public Health
 

Madison, Wisconsin
 

ANTONIO ANDRADE, Ph.D.


Group Leader, Radiation Protection Services Group


Los Alamos National Laboratory


Los Alamos, New Mexico
 

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


Director
 

The Vanderbilt Center for Occupational and Environmental


Medicine
 

Professor of Medicine
 

Nashville, Tennessee
 

RICHARD LEE ESPINOSA
 

Sheet Metal Workers Union Local #49
 

Johnson Controls
 

Los Alamos National Laboratory


Espanola, New Mexico
 
4 

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


Occupational Health Nurse Specialist


Oak Ridge Associated Universities


Occupational Health


Oak Ridge, Tennessee
 

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


Director
 

New York State Laborors’ Health and Safety Trust Fund


Albany, New York
 

WANDA I. MUNN
 

Senior Nuclear Engineer (Retired)


Richland, Washington
 

ROBERT W. PRESLEY
 

Special Projects Engineer


BWXT Y12 National Security Complex


Clinton, Tennessee
 

GENEVIEVE S. ROESSLER, Ph.D.


Professor Emeritus
 

University of Florida


Elysian, Minnesota
 

INVITED SPEAKERS
 

CORRINE HOMER
 

National Institute of Occupational Safety and Health
 

JAMES NETON, Ph.D., CHP


National Institute of Occupational Safety and Health
 

STAFF/VENDORS
 

MARIE MURRAY, Writer/Editor
 
5 

AUDIENCE PARTICIPANTS
 

GRADY CALHOUN
 

JAMES ELLENBERGER
 

TED KATZ
 

FAY MARTIN
 

DAVID MICHAELS
 

FRANK MORALES
 

DAVID RICHARDSON
 

MARY SCHUBAUER-BERIGAN
 

ROGER SHAW
 

DAVE SUNDIN
 

ROBERT G. TABOR
 
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P R O C E E D I N G S
 

8:05 a.m.
 

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

going to call the meeting back to order this
 

morning. I hope all of you had a restful night
 

and ready for another hard day of work.
 

One of our members, Jim Melius, is going to
 

join us a little later this morning. He had to
 

return to New York last night and flew back late
 

in the day, and then is flying back this morning.
 

So we're expecting him to join us before very
 

long, but we are going to go ahead and begin the
 

session.
 

I have a few announcements or housekeeping
 

matters to mention. First of all, for the
 

guests, the members of the public and others who
 

are here as observers, if you wish to have copies
 

of the minutes — the minutes, not the transcripts
 

but the minutes — of the meeting, there is a
 

sign-up book out in the foyer, and you can
 

request copies of those minutes and they will be
 

sent to you as soon as they are available.
 

Secondly, if any of you wish to make
 

comments today — that is, any of the public, the
 

observers — if you wish to make verbal comments,
 

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and you see on the schedule that that is
 

scheduled for immediately after lunch today, that
 

— again, there is a sign-up book in the foyer.
 

We ask you to sign up for that. We need to know
 

who wishes to speak so we can schedule the time.
 

I may actually schedule one of those just before
 

lunch, because I believe we had one gentleman who
 

did request a few minutes, and to accommodate his
 

schedule we may try to do that just before lunch.
 

But please sign up, in any event.
 

Lunch, again you will be on your own today
 

for lunch. That's both the Board and of course
 

the rest of you. So if you need a list of
 

restaurants that are in the nearby area, I
 

believe there's still a supply of those on the
 

table or at the front desk.
 

And then finally, there is a noon checkout
 

time. And you may have an opportunity, if you
 

haven't already checked out, to do that when we
 

recess for lunch. But if you do need a late
 

checkout, you need to request that from the
 

hotel. I'm not sure how long they will extend
 

the checkout time, and you need to work that out
 

individually.
 

Let me ask the staff if there are any other
 

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announcements that need to be made right now of a
 

general nature. It appears not, so we will
 

proceed.
 

We're going to begin this morning — we have
 

what is called an administrative orientation, and
 

that's going to be presented by Corrine Homer, or
 

known affectionately as Cori. And Cori is with
 

NIOSH, and is going to lead us through this
 

administrative overview.
 

Please, Cori.
 

MS. HOMER: Hopefully you can hear me, and
 

you may not be able to see much of me.
 

I'm going to bore you a little bit more with
 

more orientation information. And some of you
 

already are aware of this process, as you've
 

served on advisory committees or boards before.
 

But for the rest of you, I wanted to provide you
 

with some information to make the administration
 

a little less confusing to you.
 

As you are already aware, the White House
 

appoints or commissions the members for this
 

Board. This is the only Presidential advisory
 

committee that HHS has.
 

CDC/Committee Management Office provides
 

Federal advisory committee policy and guidance to
 

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NIOSH, and reviews confidential financial
 

disclosure reports and determines if waivers are
 

necessary, which you've all been through that
 

process as well.
 

What NIOSH does, at least at the
 

administrative level with myself and other staff,
 

we prepare personnel actions, arrange and prepare
 

travel orders and vouchers, request salary
 

reimbursement. We plan the meetings and provide
 

committee support.
 

In terms of personnel actions and issues, we
 

prepare and forward the personnel forms to you,
 

the members, for completion. That was that thick
 

packet of forms that you had to wade through and
 

return to us within a very short period of time,
 

which I can't tell you how much I appreciate it.
 

We assemble those forms and forward to the Human
 

Resources Management Office that makes you a
 

Special Government Employee. We also maintain
 

your status as a Special Government Employee.
 

You have one-year appointments, and we renew
 

those appointments every year based on
 

notification from Human Resources Management
 

Office.
 

In terms of your travel, we let you know of
 

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meeting dates and location. We contact you
 

directly and arrange for your flights and
 

lodging. We prepare your travel order as allowed
 

by policy and regulation. We forward your travel
 

documents and forms to you prior to the meeting,
 

and we make requested changes to your flight and
 

lodging arrangements.
 

For voucher reimbursement, which is — this
 

is where you haven't quite gotten to yet — you
 

return your original receipts and completed
 

expense sheet to us for voucher preparation. You
 

should have received an envelope that you should
 

return all of your documents to us. We go ahead,
 

based on what you've returned, and prepare your
 

voucher. We forward the voucher to you for
 

signature and return. We forward your voucher
 

for approval and reimbursement once it's been
 

returned, signed and dated by you.
 

Salary reimbursement, you're reimbursed $250
 

per day less taxes. When you receive that in
 

your bank account or with your financial
 

institution, it will not amount to $250 a day.
 

It's going to show less, based on your taxes. We
 

record your attendance at the meetings and
 

request salary reimbursement for attendees upon
 

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return to Atlanta.
 

We also compensate you for other time spent,
 

at the discretion of the Executive Secretary.
 

Now as a request to you, your preparation time
 

for this meeting was fairly significant. If you
 

can let me know individually, or let Larry know
 

what your specific time spent was reviewing the
 

documents and preparing for the meeting.
 

MR. ELLIOTT: Cori —
 

MS. HOMER: Yes, sir?
 

MR. ELLIOTT: If you could just — before we
 

leave today, before you depart, if you could just
 

write down on your little note pad how many hours
 

you spent and give that to me, with your initials
 

or signature so I know who gave it to me, and
 

then I'll pass that on to Cori to get it taken
 

care of. So hours spent in preparation of the
 

meeting.
 

MS. HOMER: We do that fairly quickly upon
 

return. We do want to make sure that your
 

voucher is paid and that your salary is
 

reimbursed as quickly as possible. We don't want
 

delays any more than you want delays, which
 

returning your voucher information — if I can
 

backtrack a little bit — returning your voucher
 

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information to me as quickly as possible helps me
 

keep my records, and helps you be able to pay on
 

your credit cards for the trip.
 

In terms of your salary, please check your
 

accounts to ensure receipt of your reimbursement.
 

We've actually had a record of members on
 

committees and subcommittees that just assumed
 

they were getting paid and never checked, and
 

years had gone by — literally, years had gone by.
 

We were receiving the appropriate documentation
 

that was saying they were paid, and they actually
 

had not been.
 

Meeting planning: We arrange for the
 

meeting and lodging space. We arrange for
 

member, staff and vendor travel. We take care of
 

writer/editor, court recorder, AV equipment
 

services, and light refreshments. We provide
 

conference support. You've seen Nichole, myself,
 

Martha DiMuzio, that the support for you has been
 

strong, and we will continue that. The staff may
 

change, but the support will not.
 

In terms of your meeting packets and
 

supplies, copying materials, you should receive
 

all that material prior to the meeting. There
 

may be occasions that you do not. We do try to
 

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prepare that and have that to you within a week
 

or two before the meeting so that you have time
 

to review that.
 

Points of contact: Your travel and
 

vouchers, at the moment, will be prepared by
 

Nichole. I believe you'll be returning your
 

voucher information to me, but since Nichole has
 

prepared your travel, any questions that you have
 

can go to either Nichole or myself. Salary,
 

personnel, administration, travel and vouchers,
 

any questions that you have at all, please don't
 

hesitate to call me. My current number is not
 

listed here as we're moving this week. As of
 

Monday my number will be what's listed. And I
 

believe you already have my current telephone
 

number.
 

If you have questions regarding your travel
 

forms, the expense sheets that I've provided, any
 

questions about your current travel or changes to
 

your flights that you need to have, please let me
 

know before we leave today, and I'll do my best
 

to answer whatever questions that I can possibly
 

answer here.
 

Any questions at all? Yes, sir.
 

DR. ANDERSON: Calendar?
 

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MS. HOMER: We'll be addressing that in a
 

few minutes.
 

DR. ZIEMER: Yeah, we'll get to the time
 

calendar shortly.
 

But any general questions on the
 

administrative issues that Cori has covered here?
 

Gen.
 

DR. ROESSLER: Mine's not a question, but
 

I've already tested your system, had to have
 

flights changed and stuff, and you're doing a
 

really good job.
 

MS. HOMER: Thank you.
 

DR. ROESSLER: So it works.
 

MS. HOMER: I'll make sure Nichole knows.
 

DR. ZIEMER: Thank you. Other comments or
 

questions?
 

Please, Larry.
 

MR. ELLIOTT: Let me segue off of what Gen
 

just offered. If there's a travel situation that
 

occurs for you in trying to get to a meeting
 

where you might — in like Gen's case, she has
 

another meeting – you're off to or going to be
 

off to —
 

DR. ROESSLER: The next meeting.
 

MR. ELLIOTT: The next meeting – we can
 

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accommodate that if we know. So please
 

articulate what your needs are, and if we can
 

we'll certainly take care of that and accommodate
 

it. If we can't, we're going to tell you that.
 

DR. ZIEMER: You mean if you're working two
 

meetings, then, back to back? Is that what
 

you're talking about?
 

MS. HOMER: Um-hum (affirmative).
 

MR. ELLIOTT: That's right.
 

DR. ZIEMER: Right, okay.
 

Okay, thank you very much, Cori, for that
 

information.
 

We'll proceed right on to the next item of
 

business, which is the Board work schedule.
 

Incidentally, I failed to mention, particularly
 

for our visitors, there are copies of the agenda
 

on the table. If you didn't get the agenda they
 

should be on the table.
 

So this is called Board work schedule, and
 

Larry, if you would take us through that.
 

MR. ELLIOTT: Well, we do need to schedule
 

the work of the Board. I think you have a sense
 

of the responsibilities of the Board and what
 

work you have facing this group. And we have our
 

next meeting scheduled for February 12th — or
 

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excuse me, 13th and 14th.
 

We need to see what we can get accomplished
 

here today toward, if possible, providing
 

comments on probability of causation rule by
 

February 6th, at a minimum. We need to discuss
 

and talk about future meetings beyond February
 

13th and 14th, if we can, so that we can get some
 

dates locked in. I don't have any specific
 

proposal, other than I think we need to figure
 

out availability here.
 

Doesn't March — we've tapped your
 

availability for March, and it doesn't look like
 

there's a time in March when all members can be
 

present. And that's okay if that's what the
 

Board wants to do, if they want to continue their
 

business without a member or two present, as long
 

as we have a quorum.
 

I don't know if there are questions about
 

the timetable of expectations that the Department
 

has. Maybe I could go over those, but I tried to
 

give you that yesterday. We'd really like — we
 

have a goal of finalizing both rules by April.
 

We plan to submit the SEC procedures to you
 

progressively over the course of the next couple
 

of meetings. It's not certain how much
 

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information on the SEC procedures we'll be able
 

to convey to you in February, but we'd also like
 

to see those guidelines put before the Board and
 

see some advice and comment on those fairly early
 

this year. So probably April or May we really
 

need the Board's attention to the SEC procedures.
 

As far as review of dose reconstructions, I
 

would propose to you that we need to give
 

ourselves a little bit of time to see NIOSH
 

complete some of those dose reconstructions and
 

have a set of dose reconstructions that could be
 

sampled from. And I would propose to you that in
 

my mind it makes sense to try to target a review
 

of dose reconstructions around July or
 

thereafter.
 

So just to give you a sense of order of
 

business here, we really need POC reviewed and
 

commented on first; dose reconstruction rule, if
 

we can, second; and then attend to the business
 

on Special Exposure Cohort after that.
 

So that I hope gives you a little bit of
 

clarity of the work before us, but we need your
 

assistance and your discussion on how to go about
 

completing that work.
 

DR. ZIEMER: Larry, on the issue of March,
 

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were there any time slots where there would be
 

one day where we could, if needed, have a
 

telephone or teleconference meeting if there was
 

a pressing matter?
 

MR. ELLIOTT: We certainly could. Just have
 

to identify —
 

DR. ZIEMER: The problem was finding, what,
 

a two-day time slot where everyone —
 

MR. ELLIOTT: We did not see a two-day time
 

slot where everybody could come in. We were
 

going to miss somebody or more than one somebody.
 

DR. ZIEMER: So I'm wondering if it would be
 

of value to go ahead — of course, the February
 

meeting is already scheduled — to find and
 

identify a time slot for March where we could
 

schedule a teleconference – it could be cancelled
 

if not needed – and then go ahead and get a
 

meeting in April.
 

Wanda, you have a comment?
 

MS. MUNN: I guess I have — I feel,
 

especially during these early months when — I
 

don't know about everyone else, but I feel as
 

though I'm going to take two or three meetings to
 

get my legs under me and really feel comfortable
 

with the process. I would much prefer for us to
 

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bite the bullet in March, and even though we have
 

to meet without a couple of members, try to go
 

ahead and have a March meeting.
 

DR. ZIEMER: What if one of the members is
 

you, Wanda? Then —
 

MS. MUNN: If one of the members is me, then
 

I'll — if we can do something like a
 

teleconference, there's a possibility that I
 

could call in and listen in then. That would be
 

very helpful, I think.
 

DR. ZIEMER: Let me ask, then — well, how do
 

others feel? Do you want to go ahead and
 

schedule a March meeting, if we can find a day
 

where maybe only — what's the best we can do in
 

terms of loss of members?
 

MR. ELLIOTT: Maybe the way we can do this,
 

you've got this calendar before you. If we can
 

look at March — and I'll let Cori start off here
 

with her availability, because she has four other
 

committees she's dealing with besides this one.
 

And so Cori, what days are you not available
 

here that we should black out?
 

MS. HOMER: The first two weeks of March,
 

starting at the 1st through the 8th, I'm not
 

available. My best availability is probably the
 

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13th on.
 

DR. ZIEMER: Okay. So do we want to go
 

around the table, then, and – well, you've
 

already collected people's schedules for March,
 

or have you?
 

MS. HOMER: I have, but that's back at the
 

office. 

MR. ELLIOTT: We failed to bring it. 

DR. ZIEMER: Okay, so we need to — 

MR. ELLIOTT: I can tell you that I'm not 

available the week of the 18th, so that narrows
 

it down a little further.
 

DR. ZIEMER: Anytime the week of the 18th?
 

MR. ELLIOTT: That whole week is out for me.
 

MS. MUNN: What do we do, 13, 14?
 

MR. ELLIOTT: I'm out 13th and 14th.
 

DR. DeHART: I'm not available the 13th. I
 

am the 14th and 15th.
 

DR. ROESSLER: Do people not like —
 

DR. ZIEMER: Are Saturdays out?
 

DR. ROESSLER: Yeah, that's what I was going
 

to say.
 

MS. HOMER: Saturdays are —
 

DR. ZIEMER: Not desirable?
 

MS. HOMER: — not desirable.
 

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DR. ZIEMER: Okay.
 

DR. ROESSLER: Not even for travel?
 

MS. HOMER: Travel's okay, if you don't mind
 

traveling on Saturday, but some folks do.
 

DR. ROESSLER: I don't mind traveling on
 

Saturday.
 

MS. MUNN: I don't, either. That's fine.
 

DR. ZIEMER: Well, looks like the week of
 

the 11th is pretty well out.
 

MS. MUNN: Did someone say they weren’t
 

available the 18th and 19th?
 

DR. ZIEMER: The 18th is out for Larry.
 

Larry has to be here, under the rules.
 

MS. MUNN: Oh, that whole week you're out?
 

DR. ELLIOTT: That whole week I’m out.
 

DR. ZIEMER: That puts us into the week of
 

the 25th. For whom is that a bad week?
 

MR. ESPINOSA: Are we limited on the Board
 

just to two days a month, or is there any way
 

(inaudible) to get some of the agenda done?
 

DR. ZIEMER: Yeah, Rich, just repeat the
 

question.
 

MR. ESPINOSA: Are we limited on two days a
 

month, or is there any way we can go like three
 

days to get some of the agenda done?
 

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DR. ZIEMER: I don't think we're limited, as
 

far as I know, are we?
 

MR. ELLIOTT: The only limitation would be
 

how much preparation we can put together in that
 

amount of time to keep you actively employed at
 

the meeting.
 

MS. MUNN: I don't know if my brain can
 

handle three days.
 

DR. ZIEMER: That's true.
 

MS. MUNN: Immediately after Easter, then,
 

or Palm Sunday?
 

DR. ZIEMER: Well, where do we stand on —
 

MS. MUNN: 25th, 26th?
 

DR. ZIEMER: For the week of the 25th, who
 

has conflicts that week? No one?
 

UNIDENTIFIED: I have one on the 27th.
 

DR. ZIEMER: You have one on the 27th. And
 

Chris (sic), we don't know Jim's schedule,
 

either, do we?
 

MS. HOMER: No, we don't.
 

DR. ZIEMER: So we may have to —
 

MS. HOMER: And he's fairly difficult to pin
 

down.
 

DR. ZIEMER: Okay. We actually may have to
 

defer completing this till Jim gets here to get
 

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that information.
 

MS. HOMER: Well, we can always connect by
 

teleconference.
 

DR. ZIEMER: Right.
 

DR. ANDERSON: What's the 25-26th look like?
 

DR. ZIEMER: Is 25-26 good for everybody
 

that's here today? Can we pencil that in as a
 

tentative?
 

UNIDENTIFIED: What's the date for Easter?
 

DR. ZIEMER: Easter is the 31st.
 

MR. ELLIOTT: 25-26 is – okay, tentatively
 

that.
 

We spoke yesterday about — I think there was
 

a suggestion about having a teleconference
 

scheduled after each Board meeting in case we
 

need it. We should perhaps think about that and
 

go ahead and schedule it. Is that the desire of
 

the Board, or — to close up loose ends left over
 

from the meeting or — and we can always cancel it
 

if there's nothing, no business to conduct. But
 

it puts us through a bind to announce in the
 

Federal Register. We have to do that so many
 

days in advance of a meeting, even a
 

teleconference meeting.
 

MS. MUNN: But it doesn't create a problem
 

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with the Register for us to cancel?
 

MR. ELLIOTT: No, it doesn't create a
 

problem if we cancel.
 

MS. HOMER: Well, I do have to amend the
 

order cancelling that, but —
 

MS. MUNN: But no public hoo-hah?
 

MS. HOMER: Well, it depends on how late the
 

cancellation comes. Because we are limited on —
 

there's just a schedule that must be kept in
 

terms of any kind of administrative —
 

MR. ELLIOTT: Prior announcements.
 

MS. HOMER: Yeah.
 

MS. MUNN: I guess my thoughts in that
 

regard are — I would think in most cases it would
 

be difficult to know till we actually got to the
 

meeting, till we got to the conclusion of our
 

meeting, whether we really were going to need a
 

follow-up or not.
 

DR. ZIEMER: There's a fair chance we may
 

need to have something for February, roughly 4th
 

or 5th, to complete what we work on here today,
 

sort of final version of our comments. So it
 

seems to me it would be prudent to get that on
 

the schedule.
 

UNIDENTIFIED: Agreed.
 

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MR. ELLIOTT: And we would need to announce
 

that as soon as we get back to the office.
 

MS. HOMER: I would probably have to prepare
 

it tomorrow —
 

MR. ELLIOTT: Right.
 

MS. HOMER: – and have it approved.
 

DR. ZIEMER: Because that's only two weeks
 

off.
 

I think we've been asked to submit our
 

comments by the 6th. Is that correct?
 

MR. ELLIOTT: Yes.
 

DR. ZIEMER: And how is the 5th for a
 

teleconference?
 

MS. MUNN: That's great. That's the
 

anniversary of the Constitution. That's
 

appropriate.
 

DR. ZIEMER: Any problems with the 5th?
 

We'll have to find a suitable — any bad times?
 

DR. DeHART: Does that give enough time for
 

final preparation and anything we formally have
 

to do on those minutes for them to have them by
 

the 6th? That's only a day.
 

MR. ELLIOTT: Well, it's the — what will be
 

going forward would be a letter from the Board.
 

It's not the minutes, per se.
 

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DR. ZIEMER: Would be the Board's comments,
 

which would be based on work we do yet today, put
 

in final form. And I assume it would be in the
 

form of a letter from me.
 

MR. ELLIOTT: Yes.
 

DR. ZIEMER: Is that correct?
 

MR. ELLIOTT: Yes.
 

DR. ZIEMER: Which could be —
 

MR. ELLIOTT: As approved by the Board.
 

DR. ZIEMER: – after approval could be
 

transmitted electronically to NIOSH or HHS.
 

MR. ELLIOTT: And I would think that in an
 

hour teleconference, anything that comes out of
 

that we could take care of and get the thing
 

turned around by the next day, if we have to
 

spend the whole night doing it, which we would.
 

DR. ZIEMER: So can we leave it for your
 

discretion as to finding a suitable time? Keep
 

in mind we have some people in different time
 

zones, so we don't want it at 8:00 in the
 

morning, I presume.
 

MS. HOMER: Perhaps if you let me know what
 

time. How much are we going to need to discuss
 

this? That's where I need to start.
 

DR. ZIEMER: We need to have — block off a
 

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minimum of an hour.
 

MS. HOMER: A minimum of an hour?
 

DR. ZIEMER: Do you have to put —
 

MS. HOMER: Yes, I do, I have to announce
 

times and amount of time.
 

DR. ZIEMER: Oh.
 

MS. MUNN: I would request that you not
 

start before 10:00 a.m. Eastern Time.
 

DR. ZIEMER: Okay.
 

MS. HOMER: That's reasonable.
 

DR. DeHART: That sounds like a good time.
 

MS. HOMER: 10:00 a.m. Eastern? 10:00 to
 

12:00?
 

DR. ZIEMER: Would you like to revise your
 

suggestion?
 

MS. MUNN: No, no, that's quite all right.
 

This is not a video conference.
 

DR. ZIEMER: Okay, block it in at 10:00 to
 

12:00, then.
 

MS. HOMER: 10:00 to 12:00?
 

DR. ZIEMER: Yeah.
 

MS. HOMER: Okay.
 

DR. ZIEMER: We can always shorten it if
 

needed.
 

MS. HOMER: That's right.
 

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UNIDENTIFIED: And that's Eastern time?
 

DR. ZIEMER: Eastern time — 10:00, 9:00,
 

8:00 — that's 7:00 on the West Coast. But —
 

let's see, you're on Mountain Time?
 

Okay, any other – now do we need to find an
 

April date as well, Larry?
 

MR. ELLIOTT: We could either tentatively
 

block off a time now and not — won't have to
 

announce it, and then see how we proceed and
 

whether we want to use it, but we'd ask people to
 

hold out whatever time we block off.
 

UNIDENTIFIED: I would recommend that.
 

DR. ZIEMER: Okay.
 

MR. ELLIOTT: And I don't know that we need
 

to go farther than April right now, at this
 

point. In February we can look at May.
 

DR. ZIEMER: Well, let me ask you this.
 

Would it be sufficient for people simply to list
 

their bad dates in April and turn those in to
 

Cori now, or —
 

MS. HOMER: Just send me an e-mail.
 

DR. ZIEMER: We don't need to verbally go
 

through —
 

MR. ELLIOTT: Or you can mark on these and
 

turn them over to Cori right —
 

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MS. HOMER: Write your name across the top
 

so I know who it is.
 

MR. ELLIOTT: Write your name across the
 

top, mark your availability for April.
 

DR. ZIEMER: And then they can work on
 

April.
 

MS. HOMER: April and May might be good, as
 

well.
 

DR. ZIEMER: April and May?
 

MS. HOMER: Yes.
 

DR. ZIEMER: Okay.
 

MS. HOMER: So that I have a month advance.
 

DR. ZIEMER: Okay. So the request is to
 

mark in April and May your bad dates, and —
 

MS. MURRAY: Excuse me, is the
 

teleconference for February 18th? Those two days
 

after the meeting, is a Saturday?
 

DR. ZIEMER: No, the 5th of February at
 

10:00.
 

MS. MURRAY: The 5th, okay. Thank you.
 

DR. ZIEMER: Okay. Larry, do you have
 

further items on the work schedule?
 

MR. ELLIOTT: I do not. I appreciate the
 

Board's accommodating this.
 

Are there questions? I'm sorry, are there
 

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questions about the work we have before us, or —
 

MS. HOMER: Can I just ask one quick
 

question? We are having all these meetings in
 

Washington, or are we going to have them in
 

another location?
 

DR. ZIEMER: That's a good question. Well,
 

let's address that for a moment. Prior to this
 

meeting there was some exchange from members to
 

the staff about whether or not it might be
 

desirable to have some meetings at other
 

locations, particularly to accommodate members of
 

the public from other locations, perhaps around
 

DOE sites. And we can certainly do that.
 

One has to think about both the convenience
 

of the location and how you would decide on one
 

site over another. We've also talked a bit —
 

some Board members have indicated a desire to
 

visit sites themselves, although it's not clear
 

if you did visit a site exactly what it is you
 

would look at, and how that would help in
 

carrying out the duties of this group.
 

But nonetheless, we can open that issue of
 

visiting sites or locations near sites — for
 

example, if the site were Los Alamos, would you
 

go to Santa Fe or would you go to Los Alamos or
 

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Albuquerque, that kind of thing. Gen.
 

DR. ROESSLER: I think it's a little
 

premature to talk about sites right now. I think
 

we need to have a couple more meetings to really
 

get out feet on the ground and know what — where
 

we're going, because once we go to a site we're
 

going to get questions from the public dealing
 

with that site.
 

DR. ZIEMER: Site-specific issues, yes.
 

DR. ROESSLER: Yeah. And I think really
 

that puts more of a burden on the Board and the
 

staff to prepare things that we're probably not
 

ready for yet. We're still trying to get up to
 

speed on what we're supposed to do.
 

DR. ZIEMER: Thank you.
 

Other comments, pro or con?
 

MR. ELLIOTT: I think Gen's point is very
 

good, and I've been thinking about this since we
 

polled the members as to their pleasure on having
 

meetings at sites and the comments that came
 

back.
 

I think it's pertinent to perhaps visit a
 

site if you have a set of dose reconstructions
 

that you're reviewing or have reviews being
 

presented to the Board, and you want to
 

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understand better what activities went on at a
 

given site, or if we have a — you're evaluating
 

an SEC petition once we have the procedures in
 

place, and you want to have a better sense of
 

what occurred at that site and why this class of
 

employees wants to petition for the SEC. In my
 

mind, that's what would trigger having a meeting
 

at a site, to inform the Board.
 

DR. ZIEMER: Any other comments? Wanda.
 

MS. MUNN: Well, just for the record early
 

on, I'm from way out in the Tooele brush. And I
 

am conflicted about this issue simply because I'm
 

aware of the fact that two-thirds of the nation's
 

defense waste is stored at my site, and the
 

processing and storage of that is the basis for
 

most of the claims that we will get from that
 

area.
 

On the other hand, my guess is my site will
 

be probably one of the lowest in per capita
 

claims for a variety of reasons, not the least of
 

which is that the individuals who might be
 

eligible for submitting claims feel very strongly
 

that they have looked after their own welfare.
 

But I want you to know that both the site
 

manager and other members of the DOE staff there
 

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have offered whatever services they can provide
 

if you choose to make this horrendous trip out
 

there, which you really can't get there from
 

here, but I can help you get there if you want
 

to. I just wanted that out for you.
 

I do believe that we're correct in assuming
 

that we don't really and truly know what we would
 

want to look at at the site yet.
 

DR. ZIEMER: Thank you, Wanda. We'll
 

interpret that as a kind invitation to visit
 

Hanford when the time is appropriate.
 

MS. MUNN: If you need that.
 

DR. ZIEMER: Yes.
 

Welcome back.
 

DR. MELIUS: Thank you. Pardon me if I am
 

off-track here, but I think we're talking about
 

the issue of site visits.
 

DR. ZIEMER: Yes.
 

DR. MELIUS: And I would just add two
 

things, and again I apologize if these have
 

already been stated.
 

One is that for members that are from the
 

West Coast, I think it's — I mean, I'm on the
 

East Coast, and it's great for me to come down to
 

Washington and so forth. But I think there is
 

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sort of an element of fairness to other members
 

of the committee that we don't hold all our
 

meetings in Washington, that some of them be held
 

elsewhere. Second — towards the West Coast.
 

Secondly, I think it's important for the
 

visibility of this program and for the people
 

that are potentially impacted by this program
 

that we do hold some of our meetings at some of
 

the sites. I think it's important that the
 

people that are affected by this program have
 

some access and appreciation of the process, and
 

some time for input into this committee through
 

the public comment period during our meetings and
 

so forth.
 

So I would urge us at some point to start
 

holding meetings at some of these sites, as
 

difficult as they may be to get to. And I've
 

traveled to many of them.
 

DR. ZIEMER: Thank you. Other comments?
 

MR. PRESLEY: Oak Ridge has already offered
 

their willingness for the support, DOE and NNSA.
 

DR. ZIEMER: Thank you.
 

It appears that there's a desire to at some
 

point visit some sites, that perhaps it's
 

premature. And I think we can agree that at
 

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least for the next two or three meetings we will
 

continue the pattern here, if this is — if one
 

meeting is a pattern, to meet here in Washington
 

till we get past the initial sort of orientation
 

of this group and the initial activities that we
 

have to engage in.
 

If I hear no strong objections to that, I
 

understand from Robert's Rules I can take that as
 

a consensus opinion.
 

MR. ELLIOTT: We are locked in in the
 

February meeting to holding it here, and that's
 

by a departmental requirement where if we travel
 

five or more people to a meeting we have to have
 

advance notice of that and approval of that. We
 

could do something for this March date you've
 

selected of 25th and 26th, Dr. Melius, if you're
 

available. And we've also asked folks to fill
 

out their availability for April and May and turn
 

that in to Cori. But we could in March, if you
 

wished, hold it in a more central location to
 

everyone, or whatever the Board's pleasure is on
 

a site.
 

DR. ZIEMER: But that doesn't have to be
 

decided today.
 

MS. HOMER: It does have to be decided soon.
 

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DR. ZIEMER: Soon, though. Like when would
 

be the —
 

MS. HOMER: Like I need to know by next week
 

where you want it.
 

MR. ELLIOTT: Well, so we need to decide
 

today.
 

DR. ZIEMER: Well, okay. Well, is there any
 

strong feeling that we should be moving out to
 

the sites by our third meeting? Or maybe not the
 

sites. Maybe it's Chicago. I was thinking
 

Lafayette, Indiana. You can't get there from
 

here, either.
 

MR. ELLIOTT: Cincinnati would welcome you.
 

MR. ESPINOSA: I'll agree with Cincinnati
 

during the baseball season.
 

DR. ZIEMER: We need you here in the
 

meeting. Wanda?
 

MS. MUNN: For some of us it's not
 

necessarily a matter of where it is, it's a
 

matter of where the planes fly to. So
 

Washington, D.C., remains a good option.
 

DR. ZIEMER: It's pretty easy to get here,
 

yes. Thank you.
 

I think I will exercise the prerogative and
 

say we'll meet here in March, unless I hear
 

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strong objection.
 

[No responses]
 

DR. ZIEMER: Now we're going to move into a
 

working session of the Board. This is a working
 

session on probability of causation.
 

Before we do that, I would like to have us
 

look at the procedural rules that a working group
 

worked on last evening. And let me begin by
 

thanking Tony for the work he did on developing
 

sort of the straw man version of this document.
 

This is a document that we discussed
 

yesterday, really our working rules on how we
 

will approach agreeing on recommendations to go
 

forward to the Secretary of Health and Human
 

Services. This is a simple, brief working
 

document. It's basically a one-pager. It deals
 

with the issue of what constitutes a quorum, what
 

constitutes a majority vote, and there may have
 

been — oh, some matters dealing with the
 

appointment of working groups and subcommittees.
 

So we're going to put the text before you
 

now here on the screen, and we'll have the
 

opportunity to look at this, and if everybody is
 

prepared to do so, to have a formal motion to
 

adopt this as our operational guidelines.
 

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So it consists of I think three main points,
 

one of which has some subpoints. Is it three —
 

well, okay.
 

MS. HOMER: There are three.
 

DR. ZIEMER: Yes, okay. Let's look at
 

these, first review it point by point, and then
 

I'll ask for a formal motion to accept this
 

document. And once it's moved to accept, we can
 

amend it if needed.
 

So on the definition of a quorum, it says
 

we'll implement HHS's definition of a quorum,
 

which is the — half the membership plus one,
 

basically. We expressed it that way rather than
 

saying six, because if additional appointments
 

are made to this committee and the number changes
 

we don't want to have to go back and amend this.
 

So it's half the membership plus one. Currently
 

that is six.
 

The Board will issue formal recommendations
 

only after a majority opinion has been reached by
 

voting — through voting by the eligible members,
 

and here's what's meant by eligible members:
 

Members that have not been required to recuse
 

themselves from participating in discussions —
 

and I think that would include voting, I guess,
 

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the matter in hand; those who've not abstained
 

from the vote — if somebody abstains the voting
 

number changes, and so what a majority — what
 

constitutes a majority changes; and then thirdly,
 

those who may not be available to participate in
 

a vote.
 

Now there is a notation here that all
 

reasonable efforts would be made to obtain the
 

vote – that is, trying to not take actions when
 

members are absent, or if they are to try to have
 

them vote, be on board by phone. But it's
 

conceivable that there could be cases where one
 

or more members were absent, in which case the
 

total number voting changes, and therefore the
 

majority changes.
 

And then the statement that the Board can
 

form subcommittees — and this, incidentally — our
 

charter does have a similar statement, and this
 

simply puts that information into the working
 

document here — that subcommittees and working
 

groups can be formed at the discretion of the
 

Chair and the Executive Secretary, and the
 

provision for outside technical experts, if
 

needed, to participate in those activities.
 

There's a difference between subcommittees
 

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and working groups. Subcommittees fall under
 

FACA guidelines in terms of meeting, and
 

typically those subcommittees have ongoing
 

responsibilities. For example, a subcommittee
 

dealing with dose reconstruction would be an
 

example. Whereas a working group is simply a
 

group formed for a specific task, such as we had
 

last night. It simply has an immediate task to
 

take care of. It is not — a working group cannot
 

act on behalf of the committee, but it can do
 

work for the committee. It brings it back for
 

the committee to act on as a group.
 

I believe that's it. I entertain a motion
 

to adopt the rules. Okay, Roy, are —
 

DR. DeHART: I move the adoption.
 

DR. ZIEMER: Move the adoption. And is
 

there a second?
 

MR. PRESLEY: Second.
 

DR. ZIEMER: Second, okay. Now discussion.
 

Yes, Jim.
 

DR. MELIUS: I would propose a modification
 

to number one that would be similar to the
 

statement we have down under the end of number
 

two, but a statement to the effect that in
 

scheduling the meetings every attempt will be
 

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made to have all Board members present so that
 

we're not scheduling for a quorum, we're
 

scheduling to the extent possible to make sure
 

that the —
 

DR. ZIEMER: I certainly — I would interpret
 

that as a friendly amendment, and we don't have
 

to formally act on that. Without objection we
 

can add a similar statement?
 

[No responses]
 

DR. ZIEMER: Thank you.
 

MR. ELLIOTT: You want me to add that right
 

now?
 

DR. ZIEMER: You can add that right now.
 

Other comments? Discussion?
 

MS. HOMER: Every reasonable effort shall be
 

made to —
 

DR. MELIUS: Ensure that all Board members
 

are available for meetings, something to that
 

effect. Or scheduled such that every reasonable
 

effort shall be made that meetings are scheduled
 

to ensure that all Board members are available.
 

DR. ZIEMER: Might have to word-smith that a
 

little bit, but I think we have the intent.
 

Any other items of discussion, questions?
 

Are we ready to vote on the operational
 

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guidelines?
 

[No responses]
 

DR. ZIEMER: I see no objection. All in
 

favor will say aye.
 

[Affirmative responses]
 

DR. ZIEMER: Any opposed, say no.
 

[No responses]
 

DR. ZIEMER: Any abstentions?
 

[No responses]
 

DR. ZIEMER: Motion carries. It appears to
 

be by unanimous consent. Thank you.
 

Now we're ready for the working session.
 

And let me outline or propose — and I'm only
 

proposing this, because this Board is so free and
 

independent it can do as it wishes, in a sense —
 

but I do have a proposal as to how we proceed,
 

and let me try this out on you.
 

We have three questions that we have been
 

asked to address. Those questions — this is on
 

probability of causation — are delineated on the
 

first page of 42 CFR 81, and you can turn to that
 

tab. It's the probability of causation
 

guidelines, or interim guidelines, I guess they
 

would be called. And there are three questions
 

we have been asked to answer. We actually talked
 

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about those three questions yesterday.
 

Now what I am proposing is that we break
 

into three working groups of three individuals
 

each. This is carefully chosen so that the Chair
 

isn't working. I would actually float from one
 

to the other, crack the whip and make sure you're
 

staying on schedule. But, no, the three working
 

groups, one for each of these questions, to
 

answer that question.
 

Now in answering that, I'm suggesting the
 

following: That not only do you consider your
 

own views and opinions relative to the items as
 

spelled out in the interim guidelines, but I ask
 

that you take a look at — I think you've all read
 

through these — number one, the comments by the
 

scientific or technical experts who've addressed
 

this. There are seven of those.
 

Do you all have copies of those with you?
 

We can bring them up on the screen, but it may
 

also be easier if you have a hard copy to work
 

with in the subgroup.
 

But insofar as the technical experts have
 

raised issues, I think it would be appropriate to
 

ask yourself are those issues ones that we are
 

concerned about in terms — because we're asked to
 

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judge whether or not appropriate use has been
 

made of current science and medicine, and we have
 

some technical input on that from others, and it
 

seems to me appropriate that we make use of that.
 

Furthermore, there are public comments that
 

you have copies of, some of which also address
 

the scientific and medical issues. I'm not
 

suggesting that we respond to public comments.
 

am suggesting that insofar as an issue has been
 

raised that rings a bell for you and you think
 

it's something you want to raise, that's fine as
 

well. Simply be cognizant of those. Obviously
 

there's some comments that are not pertinent to
 

what we're doing. Someone who says I just hope
 

the process proceeds quicker, something like
 

that, that's not an issue we're dealing with, at
 

least not directly.
 

So I'm simply suggesting that we be
 

cognizant of the public comments insofar as they
 

may have raised questions that we think are
 

appropriate, and to particularly pay attention to
 

the medical and scientific experts who have
 

raised issues on the rule-making as well.
 

Then what I suggest you do is simply jot
 

down items. This can be sentences that serve —
 

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this will serve as a jumping-off point — of
 

points of agreement about — for example, if
 

you're talking about appropriate use of current
 

science and medicine, you can break it down into,
 

for example, the risk coefficients. Has
 

appropriate use of science and medicine been used
 

in that part of the order, and on through the
 

various aspects.
 

Now this is a little sketchy, but it's a
 

jumping-off point. Now let me open the floor.
 

If someone has a different way of approaching
 

this, I'd be glad to hear it and share it and so
 

on.
 

Oh, yes. Each of the groups, there are the
 

technical staff — and let's identify precisely
 

who's here and what issues they can particularly
 

talk to, so that if you want to have one of those
 

technical staff come in and answer a question,
 

why is this done this way, or could you clarify
 

this and so on, so — and we'll identify those in
 

just a moment.
 

Let me also make a comment for the
 

observers. I would say that observers are free
 

to listen in to any of the groups. We're not
 

asking the observers to participate in the
 

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discussion, and it would in a sense be
 

inappropriate for you to do that at that point.
 

But you're certainly free to listen in to
 

deliberations, and if you want to wander around
 

and help me make sure they're doing their work,
 

that's fine. And we only have this room
 

available, so what you may need to do is just
 

move to a couple of corners of the room. We
 

might be able to use the foyer out here.
 

But let me see if somebody has an alternate
 

idea that they want to propose on how we proceed.
 

I mean, we can operate as a committee of the
 

whole, if you prefer, or we could in fact spend
 

some time as a committee of the whole to start
 

with. In fact, I actually thought we might spend
 

about a half hour and see if there are some
 

technical issues that you want the staff to
 

address as a whole before we break up. But —
 

Roy, you have a suggestion?
 

DR. DeHART: You had mentioned points of
 

agreement. There also may be points of
 

disagreement.
 

DR. ZIEMER: Well, sure, yes, of course.
 

DR. DeHART: And I think we need to keep
 

that in mind as well.
 

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DR. ZIEMER: Right, right.
 

Now our job is not to respond to the
 

comments of the scientific reviewers or of the —
 

certainly of the public. That's the job of the
 

staff folks to do. So I'm only suggesting that
 

those be used as resources to stimulate your
 

thinking about issues that may be out there.
 

Yes, Jim.
 

DR. MELIUS: A procedural question in terms
 

of the — we would break up into working groups
 

for how long, and then get back together? Is
 

that — what's the —
 

DR. ZIEMER: Oh, yes. Actually we have a
 

working session this morning. We have a working
 

session this afternoon. I don't have a good feel
 

for how much time is going to be needed or how
 

much progress we'll make, but we can see where we
 

are toward the lunch break. And incidentally,
 

there's not a formal break on the program today,
 

so in your small groups you take breaks as you
 

need it.
 

But depending on where we are, we certainly
 

come back together and see what it looks like,
 

committee as a whole; share with each other
 

because we don't want this to be done one group
 

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in isolation. So this is just a way to proceed
 

to get sort of some straw man ideas out on the
 

floor so that we can all react to. I would
 

anticipate if we make good progress this morning,
 

we operate as a committee of the whole this
 

afternoon and refine what has been done. But to
 

the extent to which we make that progress will
 

determine how we proceed.
 

Yes.
 

MR. ELLIOTT: I'd like to make one comment
 

for the Board's information. The subject matter
 

experts, the technical/scientific reviews that
 

we've facilitated and sought and Dr. Ziemer
 

mentioned a moment ago, are centered on two
 

documents primarily: One on the IREP itself, and
 

the IREP is certainly mentioned in this rule. It
 

is prominent in this rule. It's the underpinning
 

for this rule.
 

So just keep in mind that five of those
 

commenters were asked to truly evaluate the IREP
 

and the risk models associated with that. And
 

two other commenters were asked to provide
 

commentary on the dose reconstruction
 

documentation for RBEs that are used in the IREP.
 

So when you're looking at those scientific and
 

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technical comments, that's the background.
 

DR. ZIEMER: Some may not apply to this.
 

MR. ELLIOTT: Some may not apply directly to
 

this rule.
 

DR. ZIEMER: But the IREP is — takes off
 

from this, the probability of causation
 

foundation here. So insofar as it's of help,
 

that's fine. Okay.
 

Yes, Wanda.
 

MS. MUNN: My apologies to other members of
 

the committee who are not as paper-averse as I
 

am. I did not download those comments, so I'm
 

hoping that someone has a hard copy for us to
 

look at.
 

DR. ZIEMER: I have hard copies. Who else?
 

Roy does. We have several hard copies available,
 

so —
 

Is the committee comfortable in proceeding
 

in the manner described? Roy.
 

DR. DeHART: Paul, I would suggest that we
 

get together a few minutes before the lunch break
 

just to get a sense of where we are.
 

DR. ZIEMER: Yes, good idea.
 

Otherwise, are we comfortable in proceeding?
 

Jim.
 

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DR. MELIUS: I am. Just have a similar
 

aversity, as Larry knows, to carrying large
 

amounts of paper around with me. For future
 

meetings, if we're going to be discussing
 

specific things, could we make them available at
 

the meeting? You seem to have a lot of stuff
 

with you, but not some of the stuff we need now.
 

So it would be easier, that's all.
 

MR. ELLIOTT: We can get copies of these
 

made, I believe. We can get copies of these
 

subject matter —
 

DR. ZIEMER: Well, and certainly at the time
 

that the agenda was made, none of us had in mind
 

how we were going to proceed here. And in fact,
 

this was simply an idea that I generated last
 

night out of the blue, I guess you'd have to say.
 

DR. MELIUS: That's why I said for future
 

meetings.
 

DR. ZIEMER: I hope that’s not in the record.
 

No, no, thank you, Jim. That's certainly a
 

good suggestion.
 

Okay, let's take some time — let's see how
 

we are — it's just 9:00. Let's take some time
 

and see if there are some either general comments
 

or questions, particularly questions that might
 

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be addressed to the staff.
 

And let's see, Larry, can you identify who's
 

available here and remind everyone of their area
 

of expertise?
 

MR. ELLIOTT: Surely. Well, Mary Schubauer-


Berigan is here again this morning, research
 

epidemiologist that really did a lot of work on
 

this probability of causation rule and the IREP.
 

Russ Henshaw is also here, epidemiologist.
 

He knows IREP and the rule as well.
 

We have Ted Katz, who can talk to you about
 

the policy implications of the two rules.
 

We have Jim Neton and Grady Calhoun, who —
 

you didn't meet Grady yesterday other than a
 

brief introduction, but he's a health physicist,
 

as Jim is. So if you have questions on the dose
 

reconstruction aspect or what is the inputs to
 

the IREP, they can certainly help you in that
 

regard.
 

We do have — I will go into the audience
 

here to a certain extent, too. We have David
 

Richardson here, which he's one of the subject
 

matter expert commenters. I'm not sure that it's
 

fair to really tap him, given we don't have the
 

other subject matter experts here.
 

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And we certainly have — David Michaels is
 

here, if you have questions of — we have Josh
 

Silverman – if you have questions from DOE. If
 

you have questions about perhaps the intent of
 

Congress on why we were given this or what their
 

intent was to come from this, maybe Josh may help
 

us out in that regard, put the onus on Josh.
 

So that's kind of, as I view them, your
 

subject matter experts at your hand.
 

DR. ZIEMER: Thank you.
 

DR. MELIUS: Can I ask one other procedural
 

question? I don't know to what extent there were
 

any comments from reopening the rule-making, but
 

I don't believe those have been posted yet, nor
 

have we seen them. So I don't know if they're
 

available or what the status of those are.
 

MR. ELLIOTT: I have not seen them myself.
 

Dave Sundin's here, who is my Deputy, and I think
 

he has read through them. Can you —
 

MR. SUNDIN: (Inaudible).
 

DR. ZIEMER: You need to use the mike so
 

they can —
 

MR. ELLIOTT: We’re going to get you on the
 

record.
 

DR. ZIEMER: Get you on the record here.
 

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MR. SUNDIN: There were only two that I
 

recall seeing. They should be up on the web very
 

soon.
 

MS. MURRAY: Name, please?
 

MR. SUNDIN: Dave Sundin.
 

MS. MURRAY: Thank you.
 

MR. ELLIOTT: Is it possible we could have
 

them loaded up this morning?
 

MR. KATZ: I have them with me. We can make
 

copies.
 

MR. ELLIOTT: We have them with us. We can
 

make copies.
 

DR. ZIEMER: Okay. Henry has a question.
 

DR. ANDERSON: I don't know if it's a
 

procedural question or what. Specifically in the
 

proposed rules on page 50971, in the middle under
 

Updating NIOSH-IREP, it specifically mentions the
 

Board here, and it says improvements may also be
 

directly recommended by the Advisory Board, which
 

is us; and it also in the next paragraph talks
 

about substantive changes will be submitted to
 

the Advisory Board for review. I guess my
 

question is our comments at this point, are those
 

considered to be the review? Are we going to be
 

getting your revisions?
 

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MR. ELLIOTT: For the IREP?
 

DR. ANDERSON: For review? I guess it's —
 

MR. ELLIOTT: That'll be at a subsequent
 

meeting.
 

DR. ANDERSON: Are we review and approve, or
 

what is the process for subsequent changes? I
 

mean, a lot of this is — in the rule is fairly
 

non-specific. It lays down kind of the approach,
 

but doesn't get into the specifics. And really
 

my question is how easy will it be to make
 

changes? Or will you have to go back through a
 

rule amendment process, or — clearly, as you gain
 

some experience and we track that as a Board, we
 

may be making some recommendations on some of
 

these issues. And I just wasn't clear as to what
 

was going to be our role in that versus our role
 

at this point, which is kind of a — leading a
 

public comment. Are we still just in a public
 

comment thing subsequent, or do we have a special
 

standing of some kind?
 

MR. ELLIOTT: Well, your role today is to
 

review and evaluate and comment on this rule.
 

DR. ANDERSON: Yeah.
 

MR. ELLIOTT: And this passage that you've
 

quoted from this rule, as I take it — and I'll
 

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look at others to help me out here — if there are
 

changes to the IREP that we're going to make,
 

that's separate from this rule. They will be
 

brought before this Board so that you can
 

evaluate, review and comment on those substantive
 

changes to IREP. Does that —
 

DR. ANDERSON: Okay, I see.
 

MR. ELLIOTT: Does that answer your
 

question? We don't have anything to present to
 

you today on modifications to IREP based upon
 

comments we’ve received.
 

DR. ANDERSON: Right, okay.
 

MR. ELLIOTT: Okay? We may make minor
 

changes to IREP that won't be presented to this
 

Board. And I think one of them that I could give
 

as an example, Gen Roessler's come up to us, and
 

we've had other comments about this, too, on the
 

little pie charts, the little —
 

DR. ANDERSON: Yes.
 

MR. ELLIOTT: — you know, the pieces of the
 

pie don't look proportional to the percentages.
 

We'll make that change, and you're never going
 

have a chance to say anything about it, I think.
 

DR. ANDERSON: Okay.
 

MR. ELLIOTT: But if it's substantive in
 

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nature, yes, we'll bring it here to the Board.
 

DR. MELIUS: Can we go into that, I think
 

maybe a little bit, because I'm still a little
 

bit confused, Larry, on this process, because
 

changes in IREP are going to have an impact
 

beyond — it's more than a minor technical change.
 

They obviously could affect a number of claims
 

and retrospectively lead to changes in how claims
 

have to be reviewed again, and so forth. And has
 

anybody sort of thought through the process for
 

that and a timing for that? We keep making a
 

series of adjustments, or is it going to be every
 

six months? I mean, obviously to some extent
 

that's dependent on new scientific data and so
 

forth down the road, but —
 

MR. ELLIOTT: We have had a little
 

discussion about this, and we recognize that we
 

need to address it and manage it to the point
 

where we're not constantly coming forward with
 

new changes. We need to be clear on the criteria
 

that we use to say there is a change or a
 

modification to IREP that we believe needs to be
 

made, and here's why. What pieces or what points
 

of criteria does this fit to justify a
 

modification to IREP? And we would present that
 

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to you.
 

We don't envision coming to each Board
 

meeting and saying here's a new twist, a new
 

tweak of IREP, or here's another change in dose
 

reconstruction methodology. We think we need to
 

have very clear justification and good scientific
 

basis to make certain changes.
 

Does that help? That's not a very clear
 

answer, but that's about all we can give you
 

right now.
 

DR. MELIUS: That helps. What I would
 

propose, because I think it affects how we work
 

in our subcommittees and how what we comment on
 

today, is that as we think about subject matter
 

for future committee meetings that we devote a
 

considerable amount of time to sort of background
 

on the model IREP and so forth, hearing from NCI,
 

hearing from others about that, and that we do
 

that as sort of a series of briefings.
 

Therefore, when it comes up to time to consider a
 

change, we will be sort of prepared for that, and
 

not have to push it into one meeting or whatever.
 

MR. ELLIOTT: That's a good point, good
 

comment.
 

DR. MELIUS: Also that we don't then have to
 

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get into, spend a lot of time dealing with those
 

issues in terms of commenting on the rules today.
 

DR. ZIEMER: Right, right.
 

DR. MELIUS: That’s the corollary.
 

DR. ZIEMER: No, the focus today is on the
 

Part 81 itself, which is in a sense independent,
 

although —
 

DR. MELIUS: Yeah.
 

DR. ZIEMER: Okay. Okay, let's proceed.
 

Other questions or comments of a general nature?
 

[No responses]
 

DR. ZIEMER: Let me ask if the committee
 

wishes as a whole to discuss any of the three
 

questions before we break into groups? Or do you
 

want to raise any technical questions with staff
 

at this point?
 

[No responses]
 

DR. ZIEMER: There appears to be no urgent
 

questions.
 

DR. ANDERSON: Do we have a copy of the rule
 

for the — address question two?
 

DR. ZIEMER: This is the rule, this —
 

DR. ANDERSON: No, no, no, but I mean, if
 

we're asked to compare it to —
 

DR. ZIEMER: Oh, I'm sorry.
 

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DR. ANDERSON: — the atomic veterans, is it
 

consistent with —
 

DR. ZIEMER: Oh, good point. Does the
 

proposed — does the proposal appropriately adopt
 

compensation policy as it has been applied for
 

the compensation of veterans with radiation
 

exposure. Help us with that one a little bit.
 

MR. ELLIOTT: In the technical presentations
 

you got yesterday, there was mention of our
 

evaluation and understanding of the precedent
 

that's been set by the other compensation program
 

for atomic veterans, and what we could use and
 

build upon from that.
 

We don't have a report to share with you on
 

that. We can bring that in. I think maybe the
 

Government Accountability Office review report of
 

that program is on our web site. I don't know if
 

anybody printed that off. We could get that for
 

you.
 

Certainly Mary or Jim or I could talk to in
 

more detail about what we know to be their
 

experience, and I think — is Mike Schaeffer here?
 

– Defense Threat Reduction Agency is not here
 

today, but he could have perhaps answered a
 

question or two.
 

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But essentially what we tried to do was get
 

an understanding from that program as to what
 

their experience has been and what their concerns
 

or criticisms might have been from their
 

constituents, from the workers who were being —
 

or the veterans who were being compensated under
 

that program, what were the good things and
 

limitations that they experienced in that
 

program. And we tried to address those as we
 

could. We didn't spend a lot of time yesterday
 

going through that for you.
 

Is there anything that Jim or Mary would
 

like to add on that?
 

[No responses]
 

DR. DeHART: If there is someone here who
 

could go into it in more depth — I was going to
 

wait and find out which — one, two or three — I
 

was going to get involved in before addressing
 

that particular issue. But since it may touch on
 

any of us or all of us, if there is someone that
 

can provide more depth background on that, that
 

would be helpful, I think, at this time, since
 

all of us would be interested in this.
 

DR. ZIEMER: Okay.
 

DR. ANDERSON: We can't put a list up there
 

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and a list, compare it and say it looks pretty
 

close.
 

MR. ELLIOTT: This is a good question you
 

raise, because this is a difficult question to
 

answer without having more detail, which you're
 

asking for.
 

DR. ANDERSON: And we recognize what you
 

said, that you tried, you made every effort. And
 

we can say — but it's hard to independently
 

verify that. I guess that's how I see the
 

question.
 

MR. ELLIOTT: Sure.
 

DR. ZIEMER: It's certainly a valid point to
 

raise, so in fact it may be very difficult for us
 

to really deal with that effectively.
 

DR. ANDERSON: Maybe we could just respond
 

by saying we can't comment.
 

MR. ELLIOTT: We don't have any real hardcopy information other than the Government
 

Accountability Office report, and we can
 

certainly pull that up on-line. Maybe we should
 

do that for you. That might give you a little
 

more insight.
 

DR. ZIEMER: Larry, give us a little
 

background on the question itself. Is there a
 

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stipulation — I'm trying to recall if there's a
 

stipulation in the public law itself that says
 

that you have to appropriately adopt your policy
 

to —
 

MR. ELLIOTT: Well, in the Act the ancillary
 

supporting influence from this other compensation
 

program would be the IREP.
 

DR. ZIEMER: Mary, do you have comment?
 

MR. ELLIOTT: That's one of the things we
 

were charged with using, and that's used in the
 

veterans — atomic veterans compensation program.
 

We tried to talk through the experience of NCI's
 

development of that IREP with you, and what
 

modifications we sought and felt needed to be
 

made to IREP that were applicable to the work
 

force for the energy compensation program.
 

The Government Accountability Office was —
 

report was critical in one aspect with regard to
 

transparency in having an advisory body review
 

their efforts, their work, their program. We
 

felt we had that addressed with you all being
 

appointed.
 

Does that help here?
 

DR. SCHUBAUER-BERIGAN: If I could just make
 

two comments. I don't have the rule in front of
 

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me, so I can't tell you exactly where it is, but
 

it does refer to the use of the 1985
 

radioepidemiological tables to determine
 

probability of causation, and then it adds as
 

they are updated from time to time.
 

Another point I would like to make is that
 

the draft NCI report, which I believe is part of
 

your briefing book — Larry, did the committee
 

receive that briefing book that you have in front
 

of you?
 

MR. ELLIOTT: No, they did not receive this
 

briefing book.
 

DR. SCHUBAUER-BERIGAN: Did they receive the
 

NCI report?
 

MR. ELLIOTT: (Inaudible) web site.
 

DR. SCHUBAUER-BERIGAN: Okay, that actually
 

is available, and we could get copies to you.
 

But that has the NCI's justification for the
 

development of the new software program,
 

justifying the need for the changes and
 

describing some of the effects of the changes.
 

The final NCI report, I believe, will go
 

into even more detail about comparisons between
 

the new tables compared to the 1985
 

radioepidemiological tables, but I don't believe
 

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that's publicly available yet.
 

MR. KATZ: I'm sorry, Ted Katz, too.
 

Let me just add the other sort of major
 

point in terms of adapting VA policy, was that as
 

we discussed yesterday, in our case we basically
 

gave DOL guidelines that were entirely objective,
 

cut-and-dried decisions on their part; whereas
 

Veterans Affairs has an element where in the case
 

of an illness that's not covered, they have a
 

decision, a judgment that's made, that's not
 

written down on paper anywhere in terms of what
 

the decision logic is for coming to that answer.
 

So that's really the other major diversion in
 

terms of the probability of causation rule. And
 

then there are some differences with respect to
 

the dose reconstruction rule, too. But that
 

really covers it.
 

And I would just suggest that this is — this
 

actually – this question is probably a lighter
 

question, if you're thinking about dividing into
 

three groups, there's not as much really
 

discussion, I think, to be had on this question
 

as the others. So you may want to consider that
 

in terms of how you divide and conquer.
 

DR. ZIEMER: Exactly. It seems to be
 

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leading in the direction of saying we may not
 

have anything right now to say on this. It
 

appears that we would need, as a minimum, some
 

kind of a side-by-side evaluation, or something
 

we could say here's what the veteran's policy
 

was, and here's how we've adopted it to this.
 

I'm envisioning something where we can actually —
 

we need some information to answer the question.
 

Wanda, did you have a comment?
 

MS. MUNN: Yes, and the background that's
 

given — granted, there is considerable background
 

with regard to the development of the tables, et
 

cetera. However, it sounds to me as though
 

perhaps the GAO report may have condensed the VA
 

program into a manageable piece of information.
 

I don't know whether we have either the time or
 

the willingness to do the kind of line-by-line
 

comparison that perhaps some of us envision when
 

we read this, does it fit. But at last the GAO
 

report might be helpful for us.
 

DR. NETON: My recollection of the GAO
 

report — I could be wrong on this, though — is I
 

think it was primarily oriented at a review of
 

the dose reconstruction efforts under the VA
 

program that are conducted for DTRA, Defense
 

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Threat Reduction Agency. So I don't sense that
 

it would shed much light on this broader policy
 

issue of the adaptation of the IREP, of the
 

probability of causation tables. I might look at
 

that closer, but I really don't think there's a
 

lot of substantive information in there on that.
 

MS. MUNN: There must then be somewhere in
 

VA.
 

DR. NETON: Well, I think there's a VA rule.
 

I mean, there certainly is a — the VA has
 

published a rule on their dose reconstruction — I
 

mean, on their probability of causation.
 

MS. MUNN: I guess what I'm really grasping
 

for is an executive summary of how the VA rule
 

was applied and whether that was appropriate.
 

MR. ELLIOTT: I have the NCI report, draft
 

report, and the National Academy of Sciences
 

review, and this — and we can get you copies of
 

that. I can pull up the Government
 

Accountability Office report from the web site,
 

and we can show that.
 

I don't believe there is a document that
 

will enable you to go line-by-line and make a
 

point of comparison. We don't have anything like
 

that. We can pull the rule. We can get a copy
 

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of the rule, perhaps, for VA. But I think you're
 

going to find it doesn't match up to our rule in
 

any shape or form. It's presented entirely
 

different.
 

MS. MUNN: I'd expect the NAS report to have
 

much of the information I'd hope to see.
 

MR. ELLIOTT: It's on the IREP. That's on
 

the IREP.
 

DR. ZIEMER: Okay. Tony.
 

DR. ANDRADE: Paul, based on the comments
 

from around the table this morning, I think I'm
 

coming to the point where I think I'd like to
 

suggest an alternative approach to dealing with
 

those three questions, whereby we deal with these
 

three questions at the end of the day for both
 

proposed rules.
 

I think that the best that we're going to be
 

able to do, given the time frame that we have, is
 

to go paragraph by paragraph, as a committee of
 

the whole, and request comments, questions,
 

and/or issues that Board members may have with
 

respect to IREP or questions regarding the origin
 

of some of these tables, the applicability of
 

some of the scientific methods that have been
 

used.
 

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Example, the dose reduction factor, other
 

things. I have some general questions about how
 

the physicians used criteria on screening. Did
 

they take into account, for example, latency
 

periods, or did the health physicists here use
 

those things, use those types of data in IREP?
 

don't know if physicians did that beforehand, or
 

you all are doing it in IREP. So that's a
 

technical question that I have.
 

And then at the end of the day we summarize
 

what questions we have, what questions this Board
 

will be addressing, and in general how we feel
 

about those three very high-level questions.
 

DR. ZIEMER: Okay. That certainly is a
 

useful suggestion. Actually, the idea of going
 

through this initially and asking for general
 

questions is really along that same line, and
 

maybe the issue is how much time we spend on
 

that. And I think you're suggesting we operate
 

for a while as a committee of the whole and get
 

all of those questions out on the floor. And we
 

can certainly do that, sort of paragraph by
 

paragraph, and take as much time as we need on
 

it.
 

DR. ANDRADE: Exactly. And some of the
 

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paragraphs are trivial.
 

DR. ZIEMER: Sure.
 

DR. ANDRADE: They just state the obvious,
 

and so those we can go quickly through.
 

DR. ZIEMER: Any other suggestions?
 

[No responses]
 

DR. ZIEMER: Certainly willing to proceed in
 

— seem to be strong feelings one way or the
 

other, but it's a good suggestion. And I think
 

we'll be able to, by the end of that, see where
 

we are, as you've suggested. At which point we
 

can break into what probably will not be three
 

groups anyway, if we need to break into it,
 

because we're not going to be able to deal with
 

that second one. We won't have any volunteers,
 

right?
 

Okay, let's see how we're doing time-wise.
 

Let's take a brief comfort break, and then we'll
 

proceed with questions then. Fifteen minutes.
 

[Whereupon, a break was taken from
 

approximately 9:29 a.m. until
 

9:51 a.m.)
 

DR. ZIEMER: Now the path that we've agreed
 

upon is to go through 42 CFR 81 more or less
 

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paragraph by paragraph or section by section, and
 

allow the Board members to raise questions or ask
 

for clarification and make any appropriate
 

comments they wish. So let us get the material
 

before us, 42 CFR 81. We may come back to the
 

section on comments invited where it has the
 

three questions, because we have an alternate
 

framework for question two, I think, which we can
 

raise at the appropriate time that is a little
 

more clear on exactly what is needed there.
 

Is there any — so let's go to Section III, I
 

guess, which is called Background. III.A. is
 

Statutory Authority. Are there any particular
 

questions there that need clarification? Yes.
 

DR. ANDRADE: I’m not sure if the committee
 

–
 

DR. ZIEMER: Use the mike there, Tony.
 

DR. ANDRADE: I would have assumed that the
 

Board had had an opportunity to read the
 

background section, and we just really optimize
 

our time by looking at the proposed rule itself —
 

DR. ZIEMER: Okay.
 

DR. ANDRADE: — which is only two or three
 

pages. And that way I think we can plow through
 

it very quickly, and then refer back to the
 

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background if necessary.
 

DR. ZIEMER: We certainly can do that. Much
 

of the — there's a fair amount of technical
 

information in the background section, so I think
 

if there are questions on that it might be
 

appropriate, however, to — but you're suggesting
 

that we jump to —
 

DR. ANDRADE: Page 50974.
 

DR. ZIEMER: – page 50974.
 

Let me just ask if anyone wants to raise any
 

issues on the background section. Let's give the
 

opportunity at least. If not, we'll jump
 

immediately to the main body. Realize the
 

background section has a fair description of
 

probability of causation and IREP and related
 

matters.
 

[No responses]
 

DR. ZIEMER: If not, we will then skip to
 

the rule itself.
 

The main guidelines, then, begin on 50974,
 

and there's an introduction there with background
 

information again, very brief; purpose and
 

authority and provisions concerning the rule, and
 

then definitions.
 

Okay, first question.
 

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DR. ANDRADE: Let me start the questions.
 

Under background, Section 81.0, there are
 

two paragraphs that establish categories of
 

employees with cancer for whom PC must be
 

estimated or determined, and in particular in
 

paragraph (b), the category that is noted is the
 

Special Exposure Cohort.
 

Now given that the Advisory Board is to
 

suggest additions if we consider it appropriate
 

to the Special Exposure Cohort, is there a
 

subject matter expert here, either on the Board
 

or in the audience, that can address at least
 

very generally what methods or guidelines were
 

used to establish the Special Exposure Cohort so
 

that we might be able to use either similar
 

methods, if applicable?
 

DR. ZIEMER: Larry, can you help us on that?
 

MR. ELLIOTT: If I understand your question,
 

Tony, you're asking why was the Special Exposure
 

Cohort established, or how was it established?
 

DR. ANDRADE: Not so much why, but how.
 

MR. ELLIOTT: Okay. Well, that's — let me
 

try to answer your question, but before I do I
 

would say that this category here under (b), what
 

that is specifying is that those individuals who
 

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are a member of a Special Exposure Cohort who are
 

seeking compensation for a specified cancer as
 

defined, that DOL will have to use these
 

regulations to apply to that — no, not to apply
 

to that. Not for the specified cancers, that's
 

the second category. The first category is all
 

of those other than that.
 

Now the Special Exposure Cohort, how was it
 

established? Well, it was established to include
 

the three gaseous diffusion plants, primarily
 

because of what happened at Paducah. Unless
 

somebody in the audience has something they wish
 

to say about this, I do not believe that there
 

was any scientific basis, any scientific basis
 

for establishing the Special Exposure Cohort. It
 

was an accommodation given to those individuals
 

who worked in those facilities.
 

David is here, so let David Michaels speak
 

to this.
 

DR. MICHAELS: Can I rescue Larry here? I'm
 

sorry, my name is David Michaels.
 

I'm here — I'm a private citizen here on two
 

accounts. One is I'm interested in this, but
 

also I'm a consultant to the Department of Labor
 

in putting this together. I'm on the faculty at
 

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George Washington University School of Public
 

Health, but probably more importantly I was the
 

Assistant Secretary of Energy for Environment,
 

Safety and Health during the period this was put
 

together, and so was there at the conception and
 

probably even before that, that flirtation period
 

of this legislative proposal.
 

The Special Exposure Cohort — I could give
 

you a little bit of history about it and how the
 

categories that are in there were chosen.
 

Congress actually decided — the Administration
 

proposed including Paducah and then eventually
 

other sites as a Special Exposure Cohort. The
 

Senate came up with this concept of how to expand
 

the legislation and the categories slightly
 

differently from the Administration proposal.
 

I'll try to give you a sense of both of those, if
 

you don't mind.
 

The Special Exposure Cohort originally was
 

designed, as Larry said, around — to address some
 

of the issues that were detected at the Paducah
 

gaseous diffusion plant. What we determined,
 

after a great deal of investigation, were two
 

things. One is exposures occurred to levels of
 

two — not merely the uranium, which was what was
 

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everyone thought there, but there was exposure to
 

some of the transuranic materials because
 

recycled uranium was used, which will come as no
 

surprise, I think, to many people here in the
 

audience. But it was a surprise to many of the
 

workers in Paducah, and certainly to some of the
 

other interested parties.
 

What we discovered, though, at the same time
 

was there was an effort made over the course of
 

the decades when the gaseous diffusion plant was
 

in operation essentially not to determine what
 

the levels of exposure were, and not necessarily
 

take the proper precautions.
 

There is, for example, there's a memo from
 

somewhere in the 1960's saying -- this is from —
 

among the contractors at this point, saying that
 

there's a new bioassay for neptunium and we have
 

exposure, significant exposure to neptunium, and
 

that has been well documented. There's a new
 

bioassay; we should probably use it. There are
 

about 300 workers who should be tested. On the
 

other hand, if we test — if we use this new
 

bioassay the union will ask for hazard pay. And
 

so there was no — the bioassay was never
 

employed.
 

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So the history of that sort of activity led
 

the administration to propose that we establish
 

essentially a category within this legislation
 

that looked very much like the people covered by
 

the Radiation Exposure Compensation Act, which is
 

legislation passed by Congress some years
 

earlier, which covered, as many of you here know,
 

people who lived downwind from the Nevada Test
 

Site, uranium miners, and some of the on-site
 

test participants.
 

In that legislation there are categories of
 

people covered — for example, people live in
 

southern, parts of southern Utah, or people who
 

were on the test site who were not adequately
 

protected from the exposures. And it was
 

determined by Congress that if any of these
 

people who were, we'd say, in the wrong place at
 

the wrong time developed one of a list of
 

diseases, they would be compensated with a lump
 

sum compensation.
 

This was sort of an attempt to fit Paducah
 

and then the other gaseous diffusion plants onto
 

that model. And with a little bit of jimmying it
 

sort of fit in, and then Congress then added —
 

the official proposal, by the way, from the
 

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Administration was merely Paducah. That was then
 

expanded both by the Administration and Congress,
 

and then Congress at the last minute added
 

Amchitka to that.
 

The basic idea of the Administration
 

proposal was to deal with this sort of egregious
 

lack of information. Congress, however, looked
 

at it a little differently, in that Congress said
 

in putting this together — and this was really in
 

the Thompson-Bingaman process — I think the
 

members of the Senate said how do we know if
 

there are other groups who are like the Special
 

Exposure Cohort?
 

And in their thinking, they didn't really
 

want to address the question of egregious
 

misbehavior. They said, are there people who
 

just have the sorts of exposures that we cannot
 

figure out, and that we — and they really meant
 

did we not do a good job, but they never said
 

that. And then you certainly can't — I believe
 

they were thinking about that, but there's
 

certainly no record of that Congressional intent.
 

So I wouldn't say that — I couldn't tell you that
 

that was the formal Congressional intent.
 

But they said there must be people who have
 

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significant exposures, exposures enough to
 

possibly give them cancer, but we can't — this
 

dose reconstruction process that we've been
 

talking about here can't address that issue. And
 

therefore we need to have a safety valve, a way
 

to say these people should be in a Special
 

Exposure Cohort. They were clearly exposed. We
 

don't know what levels they were exposed to, but
 

we need to have a way to take care of them.
 

DR. ANDRADE: Great, thank you very much.
 

DR. MICHAELS: Sure. I'm sorry I was late
 

today, but –
 

MR. ELLIOTT: Thanks for the bailout.
 

DR. ANDRADE: That's exactly —
 

DR. ZIEMER: Thank you, David.
 

Continue, and then Jim.
 

DR. ANDRADE: That's exactly the type of
 

answer that I wanted, because if there are other
 

circumstances or we identify that there are
 

facilities or situations in which that sort of
 

activity has occurred, then clearly that would be
 

the type of guideline that we would use to add or
 

consider adding a group of people to the Special
 

Cohort.
 

DR. ZIEMER: Jim.
 

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DR. MELIUS: Just to continue on this issue,
 

I don't know if I can tell from reading it
 

because it's a bit confusing even to me, but I
 

think that second sentence refers — there are —
 

the list of cancers that are covered for Special
 

Exposure Cohorts is different than the list
 

that's covered in the general rule. So there
 

would be — I believe this is trying to refer to
 

Special Exposure Cohort members who have a cancer
 

that isn't covered under Special Exposure Cohort.
 

Is that — am I —
 

MR. ELLIOTT: The first category is anyone
 

who presents with a cancer.
 

DR. MELIUS: Right.
 

MR. ELLIOTT: The second category is a
 

member of the Special Exposure Cohort who
 

presents with one of the specified cancers.
 

DR. MELIUS: Okay. Okay.
 

MR. ELLIOTT: So if a member of a Special
 

Exposure Cohort comes forward and presents with a
 

cancer not on that list of 22, they're in
 

category one.
 

DR. MELIUS: Yeah, okay.
 

DR. ZIEMER: Okay, additional questions on
 

Section 81.0? Gen.
 

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DR. ROESSLER: Just a real quick one. I'm
 

not that familiar with gaseous diffusion plants.
 

What are the other — in addition to Paducah, what
 

are the other plants that come under this, and
 

Amchitka.
 

MR. ELLIOTT: Portsmouth Gaseous Diffusion
 

Plant at Piketon, Ohio; K-25 site in Oak Ridge;
 

and of course Paducah.
 

DR. ZIEMER: Any questions on Section 80, or
 

comments on 81.1, Purpose and authority?
 

[No responses]
 

DR. ZIEMER: 81.2?
 

[No responses]
 

DR. ZIEMER: Then we come to Subpart B,
 

Definitions. Any questions on the definitions?
 

DR. DeHART: The only question I would have
 

is that there is no defining time to indicate
 

employment. I assume that in the calculations
 

used that that is considered, that somebody must
 

have been an employee for more than X.
 

DR. ZIEMER: There's a minimum number of —
 

it's two years or something — there is a — Larry.
 

MR. ELLIOTT: Well, the employment is
 

verified. Before a claim would come to NIOSH,
 

Department of Labor would verify the employment
 

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through the Department of Energy, and also DOL
 

would verify the diagnosis, either through a
 

death certificate or a physician's report. So by
 

the time we see it, by the time this rule would
 

be used, the employment has already been
 

verified.
 

To get a little more specific in answering
 

your question, the Special Exposure Cohort
 

members would have had to have worked 250 days.
 

DR. ZIEMER: Is that only in the Special
 

Exposure Cohort, the 250?
 

MR. ELLIOTT: Yes, I think so.
 

DR. ZIEMER: No limit on the others?
 

DR. DeHART: In calculating exposure, the
 

dose over time is considered, so —
 

MR. ELLIOTT: And it's dose at first
 

employment through their dose at time of
 

diagnosis.
 

DR. ZIEMER: Tony.
 

DR. ANDRADE: I must confess that the one
 

piece of — the one document that I did not have
 

time to read with great care was the paper that
 

was presented on RBEs, Radiological — Radiation
 

Biological Effect on these factors. Are we still
 

using a definition that is based on the effect of
 

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a different type of radiation as compared to,
 

say, 200 keV, low-LET radiation photons? Is that
 

basically still the technical definition?
 

DR. ZIEMER: We've got a subject matter
 

expert here.
 

DR. NETON: I'm sorry, I'm not sure that I
 

clearly understand the question.
 

DR. ANDRADE: Okay, I'm asking for
 

clarification on RBEs, and how they are currently
 

defined and being used in IREP or in your own
 

calculations.
 

DR. NETON: RBEs are, as defined in ICRP 60,
 

are the radiation weighting factors, which are
 

essentially for purposes of compensation
 

interchangeable, are the ones used in ICRP 60.
 

DR. ANDRADE: So they are relative to the
 

effects that would be produced by low-LET
 

radiation. Is that correct?
 

DR. NETON: Right, although there are some
 

modifications for low energy X-rays that are
 

different. Is that — Mary may have to help me
 

out on the low energy X-ray section.
 

DR. SCHUBAUER-BERIGAN: Actually, the
 

reference — I think Jim's referring to the RBE
 

factors that are used in the dose reconstruction
 

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process. But referring to the document you
 

mentioned, which is written by David Coker and
 

colleagues, the RBE is actually calculated —
 

referenced to the high-energy photons.
 

DR. ANDRADE: High-energy photons.
 

DR. SCHUBAUER-BERIGAN: Yes. They're a
 

separate set of factors for each of the different
 

energies below what's considered high-energy
 

photons.
 

DR. NETON: This brings up an issue that I
 

was talking about yesterday, that when we do the
 

dose reconstruction we will use the ICRP 60
 

radiation weighting factors to report a dose to
 

the claimant that is somewhat similar to what
 

they're used to seeing as far as applying these
 

weighting factors, the radiation weighting
 

factors.
 

But when IREP is run, essentially what
 

happens is the weighting factor is removed, and
 

then the RBEs in the Coker paper are applied with
 

their uncertainty distributions about them. In
 

most cases it's almost — it's comparable, very
 

close. In certain cases there are some
 

differences, and — in those weighting factors as
 

they're applied in IREP.
 

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DR. ANDRADE: Okay. And in IREP, then, if
 

you have the distribution function of a weighting
 

factor, then do you sample that distribution
 

function as part of the mathematical technique to
 

come up with — or do you come up with a weighted
 

average or something?
 

DR. NETON: No, it's calculated just as if
 

any other uncertainty in the IREP program. It is
 

Monte Carlo calculation run-through sampling the
 

distribution as defined in the Coker paper.
 

DR. ANDRADE: Okay.
 

DR. NETON: Whether it's a triangular
 

distribution or a lognormal or whatever, it would
 

run the calculation the prescribed number of
 

times, a thousand iterations, sampling that
 

distribution probability density as defined.
 

DR. ANDRADE: All right, thanks.
 

DR. NETON: It has the effect of adding to
 

the overall uncertainty, because the RBEs are not
 

known with discrete — constant uncertainty as
 

defined in — as used for radiation protection
 

purposes. When you apply an RBE of 20 for alpha,
 

it is assumed for radiation protection that it’s
 

known without error, and in IREP it pulls that
 

out and accounts for that uncertainty in the
 

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program.
 

DR. ANDRADE: Great, thank you.
 

DR. ZIEMER: Roy.
 

DR. DeHART: Looking at (o) just above,
 

where we're talking about the
 

radioepidemiological tables, and I was wondering
 

if Mary could comment on this. David Richardson
 

talked to the linearity of low dose. Could you
 

comment on that, as well as the effects of age?
 

DR. SCHUBAUER-BERIGAN: We've received
 

similar comments to the ones that Dr. Richardson
 

brought up yesterday, as both part of our subject
 

matter expert review and as part of the public
 

comment. So I can't address how we believe that
 

the program should be modified, if at all, to
 

incorporate revisions from these comments.
 

But our thinking when creating IREP
 

initially was where it was possible and made
 

scientific sense, that we ought to rely on
 

methods that had been reviewed by scientific
 

panels. And the NCI document actually had been
 

reviewed by an NAS panel which deliberated on
 

those issues, whether the appropriate, relevant
 

models were use for age at exposure, and for the
 

application of a dose rate adjustment factor,
 

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DDREF.
 

We felt that there was good evidence
 

beginning to be brought out about differences or
 

variations from these assumptions of DDREFs that
 

had been used by NCRP and expert panels
 

throughout both the U.S. and internationally. So
 

it was our sense when developing this, the
 

modifications to the NCI program, that greater
 

evidence — greater weight should be given to a
 

DDREF closer to one. And we tried to work with
 

NCI to modify this distribution for our software,
 

and I believe that we agreed with them in the end
 

about the appropriate distribution to use. It
 

gives slightly more weight, I believe, to a DDREF
 

of one, and it includes a very — a small
 

probability that there's in fact an inverse dose-


rate effect and that the DDREF is less than one.
 

A place that we could look at this, if you
 

really wanted to take a look at the distributions
 

that are used, it's not — it is available on the
 

IREP demonstration software, but you'd have to
 

kind of delve deeply into those details, the
 

model details. And we can set this up and go
 

through that and show that to you, what the
 

eventual distribution looks like. We have — the
 

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software does not have modification for
 

incorporating the possibility of enhanced
 

susceptibility at older ages of exposure, such as
 

the one that Dr. Richardson mentioned.
 

DR. ZIEMER: Any other questions on the
 

section on definitions? Yes, Roy.
 

DR. DeHART: One other question. In the
 

list of 22 cancers, historically I'm familiar
 

with the sensitivity of many of those tissues to
 

radiation, but not all. What are we looking at
 

here, the various sources of radiation? Because
 

some of these are not common certainly to gamma,
 

so we must be looking at various sources.
 

UNIDENTIFIED: Where are you? What should
 

we be reading?
 

DR. ZIEMER: You're looking at the list of —
 

DR. SCHUBAUER-BERIGAN: Yeah, this is the
 

list of specified cancers for the Special
 

Exposure Cohort. And again, that was established
 

by Congress.
 

DR. MICHAELS: Let's — David Michaels again.
 

That list only applies to the Special Exposure
 

Cohort, and it has no relevance for dose
 

reconstruction. It was chosen, though — it's
 

simply the list that was taken from the Radiation
 

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Exposure Compensation Act list, cancers that were
 

passed by Congress, and then lung and bone were
 

added because of the transuranic exposures. And
 

that's simply — it was simply a political
 

decision. There was no scientific discussion of
 

that. Oh, and renal then was — right, renal then
 

was subsequently added in the — by Congress to
 

reflect also that that was in the — it was in the
 

original Radiation Exposure Compensation Act
 

list, but was not included in the EEOICPA initial
 

legislation. Thank you for —
 

DR. ZIEMER: Thank you, David.
 

Roy, does that answer your question?
 

DR. DeHART: One other question. Because of
 

the circumstances of aging in males, I realize
 

that prostate is not normally considered. How is
 

that handled in the reconstruction?
 

DR. SCHUBAUER-BERIGAN: Prostate is, as a
 

non-specified cancer, is covered in the IREP
 

software, so there is actually a prostate cancer
 

model. You, in the dose reconstruction process,
 

would have to calculate dose to a relevant organ,
 

and Jim can speak to that. But then you would
 

simply apply that dose calculation to the models
 

derived from the Japanese atomic bomb survivor
 

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data.
 

I believe that is collapsed into a larger
 

category with other male genitalia, if I'm not
 

mistaken. And this is one of the cancers that I
 

believe has not been shown in that study to be
 

significantly elevated. However, because of the
 

range of uncertainty about that risk estimate,
 

and given the nature of this software which
 

samples from that distribution, there is some
 

dose at which you could conceivably be
 

compensated for that cancer.
 

DR. DeHART: So it's unlike chronic
 

lymphocytic, which is excluded.
 

DR. SCHUBAUER-BERIGAN: Right, yes.
 

DR. ZIEMER: Okay, thank you.
 

DR. DeHART: Thank you.
 

DR. ZIEMER: Further questions, comments on
 

that section? We're still in definitions.
 

[No responses]
 

DR. ZIEMER: Okay, Subpart C, Data Required
 

to Estimate Probability of Causation.
 

Personnel (sic) and medical information,
 

81.5. No questions? Yes. Okay, Henry, then
 

Tony.
 

DR. ANDERSON: My question is in the
 

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race/ethnicity, is that now going to use the new
 

race/ethnicity categorizations from the current
 

census, which is quite a bit different than
 

previously? And how is that going to be covered,
 

because it won't necessarily deal with — for skin
 

cancer it's pigmentation, not ethnicity —
 

DR. SCHUBAUER-BERIGAN: The categories that
 

are used in the skin cancer models are based on,
 

you're right, on old definitions. At this point
 

we don't have incidence data for cancers for
 

these different classifications, and so it would
 

be very difficult to make use of those.
 

So this is a subject of some obvious debate
 

about how to actually enact this when a claim
 

comes in. And our recommendation is that the
 

claimant self-identify as one of the categories
 

that have been included in the IREP software,
 

which are, I believe, white — and that's divided
 

into Hispanic, non-Hispanic — African-American,
 

Asian, or Pacific Islander and Native American.
 

Those are the categories used. And if a claimant
 

were to identify as more than one race, then the
 

calculation should be done several times and the
 

higher value used. So the burden is on the
 

claimant to identify, self-identify race and
 

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ethnicity.
 

DR. ANDERSON: Again, generally the risk is
 

related to the amount of melanin in the skin.
 

Are you going to — is there any process here for
 

the physician or somebody to deal with skin color
 

actually, or the pigmentation? And I could see
 

somebody identifying their race, but — and that
 

might exclude them, but they could be very light-


skinned.
 

DR. SCHUBAUER-BERIGAN: Actually, the way
 

that the software operates, there are no — there
 

are not different risk coefficients for the
 

different ethnicities or race groups. The only
 

variance in the program is in the background
 

incidence rate, and this affects how the risk
 

coefficients are transferred to the population.
 

DR. ANDERSON: I gotcha.
 

DR. SCHUBAUER-BERIGAN: It would be very
 

difficult — we don't have any incidence rates for
 

people with different levels of — it's a very
 

crude level of categorization that has — that the
 

data exists at.
 

DR. ANDRADE: My question, I —
 

DR. ZIEMER: Use the mike, Tony, please.
 

DR. ANDRADE: My question, again — I
 

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mentioned this earlier — had to do with the use
 

of latency periods to establish whether or not a
 

given diagnosis was a credible one. Are those
 

latency periods determined in the initial
 

screening, and/or are they used in the IREP
 

software?
 

DR. SCHUBAUER-BERIGAN: Let me answer the
 

second part first. They are addressed in the
 

IREP software, and each cancer has a set of risk
 

models that adjusts for latency. There's a
 

factor that's applied to all cancers as a
 

default, which I believe assumes at least
 

somewhere between three and five years latency
 

required, and there's a step function that goes
 

between three and five years. Other cancers,
 

such as leukemia, have different latency
 

functions because the risk across latency is very
 

different for that cancer than for a cancer with
 

long latency, such as lung.
 

To answer your first questions, I believe
 

there is also in the Department of Labor program
 

some requirement that the cancer have occurred at
 

least five years after they began work — is that
 

not right? Only for Special Exposure Cohort,
 

okay. So if you're in the SEC, there is a
 

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latency requirement built into the DOL's program.
 

When a claim comes in that has to be verified.
 

But for the IREP software, that would be handled
 

on the calculation of the probability of
 

causation.
 

DR. ZIEMER: I'd like to ask for further
 

clarification. Does the program consider only
 

the exposure window that meets the latency time
 

period? In other words, subsequent exposure
 

that's more recent is excluded in the
 

calculation, or how is that handled? Do you
 

understand my question?
 

DR. SCHUBAUER-BERIGAN: Yes. Certainly
 

exposure after the incidence of the cancer is not
 

considered.
 

DR. ZIEMER: No, no, I'm talking about
 

exposure after the — after the latency —
 

DR. SCHUBAUER-BERIGAN: Yes.
 

DR. ZIEMER: — period.
 

DR. SCHUBAUER-BERIGAN: Yes. So that is not
 

—
 

DR. ZIEMER: More recent, but after — but
 

prior to the —
 

DR. SCHUBAUER-BERIGAN: Yes, you’re correct.
 

DR. ZIEMER: Okay, it does do that.
 

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UNIDENTIFIED: (Inaudible)
 

DR. ZIEMER: Pardon me? I'm not talking
 

about another source. I'm talking about exposure
 

that occurs — say the latency period is five
 

years, and the start of exposure was ten years
 

ago and the person's been exposed for ten years.
 

Does it only consider the exposure that you would
 

say logically contributed toward the cancer as
 

the dose of interest?
 

DR. SCHUBAUER-BERIGAN: Well, you would
 

input the doses throughout the entire period, and
 

the program uses the Monte Carlo simulation to
 

select basically the latency for that exposure.
 

And so exposures that occurred in between that
 

selected latency — say it was two years.
 

Exposures that occurred less than two years prior
 

to the diagnosis of cancer would not contribute
 

to their risk estimate.
 

DR. DeHART: Smoking is indicated as an
 

adjustment on lung cancer, but the relative risk
 

for smoking for upper respiratory problems —
 

cancers — for bladder, for pancreas, are also
 

significant. Were those considered in any way?
 

DR. SCHUBAUER-BERIGAN: That is also a point
 

that was raised by several reviewers, and at the
 

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time we recognized that that's true, and that
 

lung cancer is the only cancer that has an
 

adjustment, although other cancers are related,
 

obviously, to smoking.
 

I think the sense of NCI when they were
 

developing initial software is that the only
 

cancer for which we had both information about
 

association with lung cancer and information
 

about the interaction between radiation exposure
 

and that cancer risk and smoking is lung,
 

trachea, bronchus and lung. And so that issue
 

would, in our minds, have been tabled to future
 

versions of IREP when better scientific
 

information is available.
 

DR. DeHART: Thank you.
 

DR. ZIEMER: Sally.
 

MS. GADOLA: I also have a question that has
 

to do with date of the diagnosis and with
 

latency. Many cancers are not diagnosed for
 

many, many years, like multiple myeloma. And I
 

know that we talk a lot about the uncertainty as
 

far as the doses of radiation, but it seems that
 

there is a great deal of uncertainty in a clear
 

diagnosis and the date of the diagnosis. And I
 

would like to hear other comments from other
 

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96 

Board members and the experts here to clarify
 

this, if possible.
 

DR. SCHUBAUER-BERIGAN: That's a very
 

important point, and it's not one that we
 

considered directly when we were developing IREP.
 

That problem exists in studies on which these
 

risk estimates are based, and it's sort of a
 

ubiquitous problem throughout the medical
 

community.
 

I would say, though, that the effect of that
 

delayed diagnosis of cancer would be, I believe,
 

to increase the claimant's chances of getting a
 

favorable result since you would be excluding
 

less of their dose. There are some exceptions to
 

that, obviously. If you've missed a leukemia,
 

since leukemia has sort of a wave-like function
 

after exposure in the risk — the risk goes up
 

very steeply for a few years after exposure, and
 

then it tends to decrease. So if you've
 

misdiagnosed a — if you've delayed the diagnosis
 

of a leukemia, then that could be to the — add to
 

the effect — to the detriment of the claimant.
 

But we really haven't, I don't believe, got a way
 

to address that at this point.
 

MS. GADOLA: Thank you.
 

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DR. ZIEMER: Okay, we will proceed then. We
 

have next 81.6, Use of radiation dose
 

information.
 

DR. DeHART: If there is a mixed exposure,
 

do you plot each source or each type of exposure
 

independently in a mixed exposure situation —
 

X-ray, neutron?
 

DR. SCHUBAUER-BERIGAN: In the IREP software
 

there's a component for every type of exposure
 

for each period of time. So if one were — had
 

four exposure periods and were exposed to three
 

different types of radiation, there would be
 

twelve exposures for that person, and you would
 

enter the year that each occurred and the dose
 

distribution, et cetera. And those excess
 

relative risk estimates are developed for each
 

exposure, and then added together to produce the
 

final probability of causation estimate.
 

DR. ZIEMER: Okay, we'll move on to Subpart
 

D, Requirements for Risk Models Used to Estimate
 

Probability of Causation.
 

81.10, Use of cancer risk assessment models.
 

Henry.
 

DR. ANDERSON: Actually I want to just
 

briefly go back to the dose, and just ask —
 

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you're going to be gathering exposure information
 

through interview and a variety of information.
 

Do you have a process for how you're going to
 

reconcile differences? I mean, you're going to
 

get some qualitative information from the worker,
 

from other coworkers, that may contradict what
 

the measurement data is, and —
 

DR. NETON: Right.
 

DR. ANDERSON: — what's the strategy?
 

DR. NETON: That's an issue that we touch on
 

briefly in the dose reconstruction rule.
 

DR. ANDERSON: Okay.
 

DR. NETON: I don't know if we want to get
 

into that here or not, but —
 

DR. ANDERSON: Never mind. Never mind.
 

DR. NETON: Okay.
 

DR. ZIEMER: Yeah, when we get to part 82,
 

that deals specifically with dose reconstruction.
 

Okay, use of the cancer risk assessment
 

models?
 

DR. ROESSLER: Are we on (a) or (b)?
 

DR. ZIEMER: Well, we're just kind of
 

skimming through. We’ll start with (a), and if
 

nothing on (a), we go to (b).
 

DR. ROESSLER: Okay.
 

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DR. ZIEMER: Gen Roessler.
 

DR. ROESSLER: The word in here that catches
 

my attention is change, and that's what I want to
 

address. At this point in time, after hearing
 

the presentations and hearing the answers,
 

there's no question in my mind about the NIOSH
 

using the best science. That's been reconfirmed
 

in my mind over and over again at this time. And
 

I think basing the best science on decisions of
 

panels is very appropriate. They can't look at
 

every little individual paper or something that
 

comes up, so I think that's all appropriate.
 

My concern is how change is handled.
 

There's going — there are a lot of things that
 

are coming up, new studies, new information on
 

bone cancer, on some of the things Roy pointed
 

out where they're going to update. And that,
 

again, is appropriate. When there's sufficient
 

information to update the information that goes
 

into these calculations, it should be done. I'm
 

wondering how that's going to be handled — and I
 

think Jim brought this up this morning — what our
 

input is going to be. I think that we should
 

have input into it because that has a great
 

impact on the claimants.
 

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These uncertainty bounds that I brought up
 

yesterday, when they're so great in certain cases
 

now, certainly is in favor of the claimants. As
 

more information is acquired and incorporated
 

into this, this could change. And my question
 

really is, how are those changes going to be
 

addressed with time?
 

DR. ZIEMER: I think maybe Larry, you need
 

to — okay, you got one of your people to — the
 

change master.
 

MR. KATZ: It's Ted Katz here.
 

Yes, and we address that in the preamble,
 

actually. So those changes, before they are
 

effectuated, will be proposed to you, will be
 

proposed publicly because they will be part of
 

the Federal Register notice for the Board meeting
 

that's coming up. So they'll be explained in
 

that meeting and in the Federal Register notice.
 

They will be proposed to the Board. The Board
 

will have an opportunity to deliberate over those
 

changes before they are effectuated, and they'll
 

know the results. So there'll be a public
 

process, with you right in the middle of it, for
 

deliberating over those changes.
 

DR. ROESSLER: Okay. Then my follow-up
 

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question is how do you define changes? I'm
 

assuming that this only — you only have to go
 

through this for really major —
 

MR. KATZ: Exactly, and that's what we
 

discuss, is this process — you'll actually have
 

information whenever we make changes, but you
 

won't have to deliberate over, as Larry explained
 

earlier, over changes that don't have consequence
 

for claimants.
 

DR. ZIEMER: Jim.
 

DR. MELIUS: Is there a reason that the
 

process is not reflected in the regulations? Why
 

is it in the preamble and not in the regulations?
 

MR. KATZ: It's in the preamble because —
 

because — well, I'll just say because HHS
 

believes that that's the appropriate place to
 

address those procedures.
 

DR. MELIUS: Can you elaborate on —
 

MR. KATZ: Well, that's really — it's really
 

very simple. HHS made a very clear determination
 

that those — that procedure should be part of the
 

preamble.
 

DR. MELIUS: Is that a legal recommendation,
 

or is that a policy —
 

MR. KATZ: I think it’s a — it's a
 

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combination of legal and policy, but this comes
 

from HHS. This was a determination made by HHS,
 

that that belonged in the preamble.
 

DR. MELIUS: That's not a very satisfactory
 

answer, Ted.
 

MR. KATZ: It's a completely frank –
 

UNIDENTIFIED: It’s honest.
 

DR. MELIUS: I didn't say it was dishonest,
 

I just didn't say it was very satisfactory.
 

MR. KATZ: — unabbreviated, unedited answer,
 

is all I can say.
 

DR. ANDERSON: What are the consequences, I
 

think is really the question.
 

DR. ZIEMER: Well, do you have a concern
 

that if it's not codified in the rule itself that
 

it somehow can be bypassed?
 

DR. MELIUS: Yeah, that was sort of the
 

question I'm trying to get. How was this
 

procedure —
 

MR. KATZ: The legal consequences of it
 

being in the preamble — exactly right — means
 

it's not binding by law. It's not binding. It's
 

– because it's in the preamble it's still within
 

the discretion of the agency to apply that
 

procedure. But I think the thing was, you put it
 

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in the preamble, you make the procedure public,
 

and the public will hold you accountable to that
 

procedure.
 

MR. ELLIOTT: It is certainly something the
 

Board can comment on. I think if you —
 

MR. KATZ: Right. This is — it's open to
 

comment, absolutely.
 

MR. ELLIOTT: — if you feel strongly that
 

that procedure needs to be clarified and outlined
 

and presented in the rule, not in the preamble,
 

that's where you should make your comment.
 

DR. ZIEMER: Okay. Tony.
 

DR. ANDRADE: I'd like to agree, and to back
 

Dr. Melius' suggestion that somehow we consider
 

the question of including language within the
 

rule, even if it's simple, for the sake of
 

transparency to the public that changes may
 

occur, and that these changes, when substantive,
 

will come to the attention of the Board, and
 

therefore will be published in the Federal
 

Register, et cetera. Again, for the sake of
 

transparency.
 

Also, although this is not one of my
 

concerns, certainly Shelby — the person who spoke
 

to us from the Department of Labor yesterday —
 

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DR. ZIEMER: Shelby Hallmark.
 

DR. ANDRADE: — Hallmark, was very concerned
 

that changes could bring compensation levels down
 

or up. And I feel that that's really — whether
 

they go up or down shouldn't be so much a concern
 

to us as making clear to the public why these
 

changes have occurred. And therefore I think
 

there's a good basis for having — for including
 

language there.
 

And I would propose that the Advisory Board
 

submit this as a comment on this proposed
 

legislation.
 

DR. ZIEMER: Are you proposing that at this
 

time as a formal action?
 

DR. ANDRADE: Yes.
 

DR. ZIEMER: So you can certainly do that,
 

and —
 

MS. MURRAY: Could you repeat that, please?
 

DR. ANDRADE: I don't know if I can repeat
 

it, but let me try.
 

I would like to propose that the Board
 

comment to HHS that we include language on the
 

probability or the possibility that compensation
 

levels may change as a result of new science
 

being added into the modeling process that is
 

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used to determine those — the probability of
 

causation.
 

DR. ZIEMER: If I might, Tony, Henry has
 

pointed out that there is language to that effect
 

in the preamble, and the issue would be to move
 

the —
 

DR. ANDRADE: To move it?
 

DR. ZIEMER: — language into the body.
 

DR. ANDRADE: Yeah, I think that's —
 

DR. MELIUS: Yeah, they mention change in
 

the regulation, they just don't mention the
 

process. We want to move some sort of process
 

language —
 

DR. ZIEMER: So is that the intent of your
 

motion, is to move that language into the body of
 

the —
 

DR. ANDRADE: Yes.
 

DR. ZIEMER: — the rule itself?
 

DR. ANDRADE: Exactly, and clarify these two
 

points. One is that some general comment about
 

process should be included, and I think that that
 

language is there. However, it should also be
 

noted that changes in compensation levels as a
 

result of changes in science, and therefore PC —
 

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DR. ZIEMER: Right, and those words are in
 

the present language.
 

DR. ANDRADE: — may occur.
 

DR. ZIEMER: Yeah. So the motion, I want to
 

hear a second on that.
 

DR. MELIUS: I'll second.
 

DR. ZIEMER: And to second it is to
 

recommend to NIOSH that that language dealing
 

with change be made a part of the rule itself so
 

it's very clear that it's a requirement.
 

And just parenthetically, I might add, we're
 

not talking about, for example, changes in IREP
 

that make it easier to use or make it prettier or
 

whatever, make the pie charts right. We're
 

talking about things that affect the outcome.
 

DR. ANDRADE: Yes.
 

DR. ZIEMER: And did we get a second to the
 

motion? Jim, you seconded.
 

DR. MELIUS: I seconded.
 

DR. ZIEMER: Is there further discussion on
 

that? Yes, Wanda, please.
 

MS. MUNN: I would suggest we be very
 

careful in the wording of that particular
 

statement. I personally would not use level of
 

compensation. That would lead people to believe
 

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—
 

DR. ZIEMER: Yes, the compensation amount is
 

a fixed amount.
 

MS. MUNN: It's set.
 

DR. ZIEMER: The awarding of compensation is
 

the issue.
 

MS. MUNN: So one — yeah, yeah.
 

DR. ZIEMER: And I believe —
 

MS. MUNN: The probability of compensation.
 

DR. ZIEMER: The words are on page 50971,
 

middle column, second full paragraph. It says
 

substantive changes that would substantially
 

affect estimates of probability of causation . .
 

. will be submitted to the Advisory Board on
 

Radiation and Worker Health for review. It also
 

goes on to talk about public comment. I believe
 

that's the language.
 

Is it — would that — if that's the language
 

that we're talking about in the motion, would
 

that be suitable, Wanda, as you understood it?
 

DR. ANDERSON: Just put after substantive
 

changes, changes which would affect.
 

DR. ZIEMER: And it says here, changes that
 

would substantially affect estimates of
 

probability of causation calculated using NIOSHNANCY LEE & ASSOCIATES
 
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IREP.
 

DR. ANDRADE: That certainly addresses my
 

concern. I'm not sure if that completely
 

addresses —
 

DR. MELIUS: No, it does.
 

DR. ANDRADE: — Jim's concern.
 

DR. MELIUS: It does.
 

DR. ZIEMER: Then by implication it affects
 

the award if it affects the probability of
 

causation. We don't have to say the awarding of
 

compensation.
 

MS. MUNN: No.
 

DR. ZIEMER: Is it still the same motion?
 

think it is.
 

MS. MUNN: I think so.
 

And I'm still — I don't think this needs to
 

be incorporated in the language, but a procedural
 

issue for my own edification. I'm assuming,
 

then, that any substantial change which would
 

affect a category of claimant would then be
 

pulled out for review after the fact. For
 

example, had a claimant already been rejected at
 

the 43 percent level, say, and this new
 

information might affect that individual, do we
 

then retroactively look at that claim again?
 

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MR. ELLIOTT: Yes. Yes, we would.
 

DR. ZIEMER: Parenthetically, what if the
 

new data would have invalidated an earlier claim?
 

MR. ELLIOTT: No, we don't.
 

DR. ZIEMER: We send the collectors out to —
 

UNIDENTIFIED: You can’t get it back.
 

DR. ZIEMER: Further discussion on this
 

motion?
 

Ted, please, you have a comment pertinent to
 

this?
 

MR. ELLIOTT: We have had discussion on
 

this. I think it would be helpful to —
 

DR. ZIEMER: Go ahead, yes, please.
 

MR. ELLIOTT: This is a concern we do have.
 

MR. KATZ: So yes, that's an obvious issue.
 

That’s an issue that concerned us.
 

And I believe — and Pete's here, who could
 

speak more specifically to the DOL rules — but I
 

believe under the DOL interim final rule now, a
 

claimant has a time period to bring back a claim
 

that's been denied as a result of new
 

information. This is exactly that sort of new
 

information, so there's that opportunity. Also,
 

the Department of Labor has its own authority,
 

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with no time constraints whatsoever, to review a
 

claim, to reopen a claim on the basis, for
 

example, of new information.
 

DR. ZIEMER: Okay. We're ready, then, to
 

vote on this motion. And if this motion passes,
 

this will become one of our specific
 

recommendations. This will require at least six
 

votes.
 

MS. MURRAY: May I have a clarification for
 

the minutes? Is the motion now in effect to move
 

this, verbatim, into the body of the rules?
 

DR. ZIEMER: Yes, and thus have the effect
 

of becoming part of the rule.
 

DR. ANDERSON: And the Board becomes
 

(inaudible). The first action of any board is to
 

(inaudible).
 

[Laughter]
 

DR. ZIEMER: Okay, are you ready to vote?
 

And a vote of six or more will cause this to
 

pass.
 

All in favor say aye.
 

[Affirmative responses]
 

DR. ZIEMER: The Chairman is also voting
 

aye. And all opposed say no.
 

[No responses]
 

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DR. ZIEMER: The motion carries. Again, a
 

sort of unanimous consent, it appears.
 

DR. DeHART: A procedural question on the
 

motion, basically. If this is published, as it
 

will be, any change in the Federal Registry for
 

public comment, I assume the Board will be
 

provided all public comments to review.
 

MR. ELLIOTT: Oh, you mean if we have a
 

substantive change?
 

DR. DeHART: Yes.
 

MR. ELLIOTT: Yes. Yeah, we will, as we
 

have on these rules here, any further effort to
 

change the rules or to change IREP or the SEC
 

guidelines when we present those to you, we'll
 

share all those comments with you.
 

DR. ZIEMER: Okay, thank you.
 

Let us proceed. That was 81.10, subset (b).
 

Anything else on (b)? There are several
 

subparagraphs there numbered (1) through (5)
 

under (b).
 

[No responses]
 

DR. ZIEMER: Okay, we'll move on. We can
 

always backtrack if something pops into your
 

mind. Let's move on then.
 

Now we come to 81.11, which is the use of
 

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uncertainty analysis in NIOSH-IREP. Paragraph
 

(a), the use of uncertainty in the calculation.
 

I do have one question on that. In the
 

calculation, for example, for photons, I think
 

you end up using acute exposures for external
 

photons — and someone can help me if that's not
 

correct — that's true. Is that a default
 

position, or can you in fact use chronic if you
 

have information that would — or is it
 

automatically acute?
 

DR. NETON: Unless information's available
 

otherwise, it would be acute. But the chronic
 

scenario would be available as an option if it
 

were obvious from the records that that were the
 

case.
 

DR. ZIEMER: I hadn't tried it, but I wasn't
 

sure whether the program mandated —
 

DR. NETON: Oh, no, no. It's not a default
 

within IREP itself. It's actually imbedded
 

within our technical guidelines for dose
 

reconstruction for input, for creation of the
 

input table that would go to the Department of
 

Labor for probability of causation calculation.
 

Although, that being said, I'm not sure that
 

I can envision with current personal monitoring
 

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programs, how would we be able to ascertain a
 

chronic exposure scenario.
 

DR. ZIEMER: Well, I don't know the answer
 

to that, either, and that's sort of a dose
 

reconstruction issue.
 

DR. NETON: Right.
 

DR. ZIEMER: My only point here was that it
 

does affect what kind of distribution appears,
 

and then that affects the uncertainty analysis as
 

well. Okay.
 

DR. ANDRADE: Could I ask a question?
 

DR. ZIEMER: Tony, please.
 

DR. ANDRADE: That is taking a more
 

conservative stance as well, isn't it, in the
 

sense that at least for low-LET radiation when
 

you have a chronic or — I mean, acute exposures,
 

research has shown that the dose response
 

relationship is higher. So it is a more
 

conservative approach to —
 

DR. NETON: Well, it is to apply an acute
 

exposure that was instantaneously delivered for
 

the dose-rate effectiveness factor, that's
 

correct. I may be stretching my limitations on
 

my health physics knowledge, and Mary may have to
 

help me out here, but there's also – it is a
 

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DDREF, so it's dose and dose-rate effectiveness
 

factor. And I believe as was pointed out
 

yesterday, for exposures under 20 rem, I think is
 

the way it was developed, the factor is — it
 

wouldn't make any difference, I don't think, in
 

the DDREF if you applied it as acute.
 

Is that correct, Mary?
 

DR. SCHUBAUER-BERIGAN: Not exactly.
 

DR. NETON: Okay.
 

DR. SCHUBAUER-BERIGAN: It's very
 

complicated. And really, without looking in
 

detail at the NCI's model documentation, it's
 

very difficult to explain what happens.
 

But at some dose, some theoretical low dose,
 

even for an acute exposure, there is applied the
 

chronic DDREF factor. That acute dose, that
 

acute low dose, though, is sampled from a
 

distribution of possible low doses. And if
 

Charles Land were here, he really developed that
 

with NCI and could speak to much greater detail
 

about how that's done. But that's documented in
 

the NCI's revised software. That dose value
 

ranges from — that so-called low dose value
 

ranges from .03 to .2 sievert, so that would be 3
 

to 20 rem.
 

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DR. ANDRADE: Thank you.
 

MS. MURRAY: Was that .03 to .2 sievert?
 

DR. SCHUBAUER-BERIGAN: Yes.
 

MS. MURRAY: Thank you.
 

DR. ZIEMER: Are we ready to go on to the
 

next section? Okay, Subpart E, Guidelines to —
 

no, I'm sorry. Yes, Subpart E, Guidelines to
 

Estimate Probability of Causation. Required use
 

of NIOSH-IREP, 81.20.
 

[No responses]
 

DR. ZIEMER: Okay, 81.21, Cancers requiring
 

the use of NIOSH-IREP.
 

DR. DeHART: A question related to carcinoma
 

in situ, which is sort of an interesting
 

conundrum because the diagnosis in fact is going
 

to imply treatment. It is not a metastatic
 

disease; therefore the fact that you found it,
 

you've cured it, in all probability. What was
 

the rationale for including it?
 

DR. SCHUBAUER-BERIGAN: The rationale for
 

including it is — this was a topic of some
 

discussion as these regulations were produced.
 

The justification was that as cancer screening
 

techniques have improved in this country — and
 

I'll use breast cancer as an example — carcinoma
 

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in situ is frequently the stage at which cancers
 

are caught and diagnosed and treated. And
 

treatment, in many cases, is identical for a
 

carcinoma in situ as it would be for early stage
 

metastatic cancer.
 

And so it was felt that that — making that
 

distinction between carcinoma in situ and a
 

malignant early stage cancer could in fact punish
 

somebody for finding a cancer earlier. And that
 

is the application of a policy decision that was
 

made, similar to decisions — when faced with an
 

unknown like that, the decision should be made in
 

favor of the claimant, which would be to consider
 

that. And that's certainly something that is —
 

should be considered as the Board makes its
 

decisions.
 

One other factor I should point out is that
 

for some cancers like breast cancer, the risk
 

factors for carcinoma in situ are the same as for
 

early stage breast cancer itself. And so one
 

could argue that it's likely that radiation might
 

cause those cancers or those carcinomas similarly
 

as for malignancies.
 

DR. ZIEMER: Okay, we'll move on to 81.21,
 

general guidelines for use of NIOSH-IREP.
 

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Yes.
 

DR. ANDERSON: I notice there's a couple of
 

places it says DOL will calculate probability of
 

causation. Who's going to be actually doing
 

this? Are you —
 

MR. ELLIOTT: The Department of Labor has
 

that responsibility. That's part of their final
 

adjudication of the claim. They will use our
 

rule. They will use this rule and the
 

information that we send them from a dose
 

reconstruction report and the IREP to do that
 

calculation.
 

DR. ANDERSON: So they'll basically get the
 

table saying 53 percent, and they'll look at that
 

and say meets the criteria, and that's — no?
 

MR. KATZ: They'll actually operate the
 

IREP.
 

MR. ELLIOTT: They'll actually operate the
 

IREP.
 

DR. ANDERSON: Okay, so they'll be doing all
 

of that.
 

MR. ELLIOTT: Yes.
 

DR. NETON: Yes, it's our intent that they
 

will receive essentially an Excel spreadsheet
 

that will contain the detailed dosimetric
 

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evaluation that we do, and then they will import
 

that into IREP and actually execute the program
 

and generate the results.
 

DR. ANDERSON: I see. So you'll just
 

calculate or generate the dose.
 

MR. ELLIOTT: That's right.
 

DR. ZIEMER: 81.23, Guidelines for cancers
 

for which the primary site is unknown.
 

I'm just reminded that that includes Table 1
 

as well, so if there's questions on Table 1.
 

It's not very clearly identified, but it's the
 

table right at the bottom. The Table 1 heading
 

looks like a paragraph right under 81.23, but I
 

think it is the heading for the table. Okay?
 

And we've already been informed as to how
 

this will work in terms of multiple cancers and
 

multiple calculations, and selection of the
 

highest probability in adjudicating the claim.
 

81.24, Guidelines for leukemia.
 

[No responses]
 

DR. ZIEMER: No questions? Okay, 81.25.
 

have one question on 81.25 on the calculational
 

method. Is there some assumption about the
 

independence of the cancers where you have
 

multiple cancers and do the combining of the
 

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probability of causations? Or maybe a better way
 

to frame that is the independence of the risks of
 

those cancers.
 

DR. SCHUBAUER-BERIGAN: Yes, those are
 

assumed to be independent probabilities for
 

purpose of this calculation, and that is the
 

derivation of that equation.
 

DR. ZIEMER: And if the two cancers are not
 

independent — I'm not sure if I even know what
 

that means in medical terms — is metastases in
 

one organ — or primary/secondary situation, is
 

that — or does this arise in that case?
 

DR. SCHUBAUER-BERIGAN: Here we're not
 

referring to — obviously to a secondary cancer
 

arising from a primary. But for example, if you
 

receive — if you had colon cancer and skin
 

cancer, it's likely that those are two
 

independent processes leading to those two
 

diseases. So that was the thinking in setting
 

this equation up.
 

DR. ANDERSON: An interesting question,
 

because skin cancer's going to be involved. Is
 

the time relationship between the two cancers
 

come into play at all? It would seem to me
 

somebody could apply for, under the – getting an
 

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early skin cancer, then since most of them will
 

survive go on to another 20 years, develop a
 

colon cancer, or a woman a breast cancer or
 

something.
 

Now if they'd already applied and been
 

denied under the earlier, would that still count
 

in the subsequent one as opposed to having two
 

cancers that occur within — simultaneously? Now
 

part of this would be going — historically you
 

look at people who are already deceased and they
 

died of the second cancer, but their medical
 

history suggests they had — and again, skin is
 

relatively common and treatable.
 

UNIDENTIFIED: Combining helps them.
 

DR. ANDERSON: Yeah, combining helps them.
 

DR. SCHUBAUER-BERIGAN: Right.
 

DR. ANDERSON: Is there no statute of
 

limitations, was really the question.
 

DR. SCHUBAUER-BERIGAN: No. This
 

calculation could apply to cancers that — primary
 

cancers that occurred decades apart. And you
 

would compute each probability of causation
 

independently for each cancer, and then apply
 

this equation to combine the two.
 

DR. MICHAELS: May I just add one point just
 

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for informational sake — David Michaels.
 

Claimants would be eligible for only one lump sum
 

payment though, even if they had multiple
 

cancers. However, it's of interest to the Labor
 

Department to determine which cancers are causal,
 

because medical payments associated with each
 

cancer have to be determined.
 

DR. ZIEMER: Let's see, we were at
 

guidelines for leukemia. Were there any
 

questions on — no, we're — I'm sorry, I passed
 

that. We were on guidelines for claims including
 

two or more. Any other questions on that
 

section?
 

[No responses]
 

DR. ZIEMER: Okay, 81.30, Non-radiogenic
 

cancers, including the tables.
 

DR. ANDRADE: Just out of general interest,
 

I'd ask the physicians here on the panel if they
 

are aware of any research that is indicating any
 

other type of cancer that may be considered or
 

that may possibly be non-radiogenic.
 

DR. ZIEMER: Roy.
 

DR. DeHART: I don't know of any absolutes,
 

and in medicine that's very hard, even for
 

chronic lymphocytic. There are certainly, as we
 

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all know, various tissues that are more sensitive
 

than other tissues, but I couldn't give you a
 

tissue that would be non-responsive to radiation.
 

DR. ZIEMER: Henry, did you have any other
 

comments that —
 

DR. ANDERSON: No.
 

DR. ZIEMER: Okay. It appears that that
 

brings us to the end of the rule itself.
 

DR. ANDERSON: Oh —
 

DR. ZIEMER: Oh, another question?
 

DR. ANDERSON: When the ICD changes — it's
 

happening as we speak — are you just going to
 

update the tables? Are you going to have to go
 

through a rule process? You need to put in here
 

somewhere so that you don't have to go through
 

this rule-making process —
 

MR. KATZ: Yeah.
 

DR. ANDERSON: — when the codes change.
 

MR. KATZ: I think this falls — and I don't
 

remember the term — but these sort of technical,
 

non-substantive changes can be done without going
 

through a rule-making process.
 

DR. ANDERSON: Well, just be sure that you
 

can do that because it saves you a lot of
 

headache.
 

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DR. SCHUBAUER-BERIGAN: We actually
 

considered — ICD-10 is in effect right now.
 

However, the risk models on which —
 

DR. ANDERSON: Are all based on —
 

DR. SCHUBAUER-BERIGAN: Yeah, are based on
 

ICD-9 classifications.
 

UNIDENTIFIED: Say that again.
 

DR. SCHUBAUER-BERIGAN: To repeat, the risk
 

models are in ICD-9 codes, and therefore — you
 

can still code any cancer, incident cancer or
 

case of a death in any of the ICD revisions. So
 

it's not a requirement for this program that they
 

be done in the most current revision of ICD.
 

DR. ZIEMER: You're talking about the —
 

adding to the list mainly, or are you —
 

DR. ANDERSON: Well, the numbers have
 

changed, yeah. Some of the —
 

DR. ZIEMER: Oh, the coding numbers
 

themselves, oh.
 

DR. ANDERSON: – broken down into different
 

types that would otherwise have been included in
 

this, now they'll have a separate category, so
 

they might – you can always back-code your
 

numbers. Generally you can translate backward,
 

but it's more problematic going from 9 to 10.
 

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DR. ZIEMER: Okay. Now opportunity for any
 

other general questions on the rule, proposed
 

rule.
 

[No responses]
 

DR. ZIEMER: Then we have completed that
 

review. We actually even have at least one
 

recommendation, made sort of progress.
 

We do now have an opportunity to frame out
 

question two of the preamble, and we're going to
 

distribute the rule for Veterans Affairs — not
 

overly long. And then referring to question two,
 

I'm going to ask Ted – maybe some of his
 

colleagues can frame what the real intent of
 

question two is, and it really has to do with the
 

use of the POC tables.
 

MR. KATZ: Yes, sure. There's really, I
 

guess, two more specific questions under that
 

question which you could address. And the first
 

is are the categories sort of possibilities for
 

changes to IREP the appropriate ones, because
 

that is an adaptation.
 

DR. ZIEMER: That is changes of IREP from
 

its use in the other —
 

MR. KATZ: Right, and those are specified —
 

I don't have the section number in my head, but
 

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you have it. You reviewed it actually just now.
 

You went through that section as well, and you
 

said you might return to it. But it's the
 

section of the rule that describes what possible
 

changes would be made to IREP. So that's the
 

first question.
 

And the second question in terms of
 

adaptation pertinent to this rule is our approach
 

to in effect objectifying decisions where we're
 

dealing with unknowns – for example, not knowing
 

the primary cancer, or for example not having
 

necessarily a best, single best model. Is that
 

appropriate, using that objective approach versus
 

what is applied at Department of Veterans Affairs
 

when you have, for example, a disease that's not
 

included, is you have in effect an expert
 

judgment being applied. So it's not a consistent
 

— it may be — the expert judgment may be
 

consistent, but it's not laid out objectively and
 

cut and dried.
 

DR. ZIEMER: Larry, do you have anything to
 

add to that, or any of the other staffers?
 

[No responses]
 

DR. ZIEMER: So this question would really
 

take the form of does this rule appropriately
 

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adopt the IREP model to this work force? Is that
 

a fair way of —
 

MR. ELLIOTT: I think that is.
 

DR. ZIEMER: And the primary changes on that
 

adoption are what?
 

Henry, did you have a question?
 

DR. ANDERSON: Yeah, my question is some of
 

these things in the Veterans Affairs issue, like
 

the referral to independent experts, if they’re
 

to reconcile, which is kind of one of the
 

questions I had, how would that be done? Is that
 

something that will be in the Department of —
 

since basically you're not going to be doing it,
 

you're going to dose reconstruct, it's how do you
 

— I guess my question is where does Department of
 

Labor come in in this? When they make the
 

determination, do they have a process that's
 

somewhat qualitative rather than strictly
 

quantitative?
 

I mean, like that's kind of what the VA has
 

here. If there's an issue needs to be decided,
 

it can be sent to, as you say, for expert
 

opinion; where here what you have is basically a
 

model. You fit the data you have into the model.
 

The only thing would be when we get to dose
 

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reconstruction, if you say you can't do it, then
 

the question is is it your responsibility to come
 

up with an alternative process? Or do you just
 

leave that to Department of Labor, and they would
 

decide whether the person would go into a special
 

group or be handled in some other way?
 

MR. ELLIOTT: That's where our Special
 

Exposure Cohort guidelines —
 

DR. ANDERSON: And that's coming later,
 

okay.
 

MR. ELLIOTT: — come into play, and that's
 

coming down the pike. We don't have that —
 

DR. ANDERSON: Okay.
 

MR. ELLIOTT: — ready to present to you
 

today.
 

DR. ANDERSON: Because it seems you're just —
 

most of your rule is the mechanics.
 

MR. ELLIOTT: Yes.
 

DR. ANDERSON: And therefore, once you have
 

the program on-line, you can put something into a
 

field. But you can't add fields, you can't —
 

your choices are relatively —
 

MR. ELLIOTT: As Jim Neton mentioned
 

earlier, it's our intent to deliver a dose
 

reconstruction report to the claimant, to
 

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Department of Labor, and Department of Energy.
 

And what Department of Labor's going to get in
 

that dose reconstruction report is an Excel
 

spreadsheet that has all of the input parameters
 

for the IREP from that dose reconstruction. It
 

takes out all of the subjective interpretation on
 

their behalf to provide a very objective,
 

specified parameters to plug into the program.
 

And then all they have to do is hit that one —
 

DR. ANDERSON: Yeah.
 

MR. ELLIOTT: — submit data button and put
 

the calculation, and they have the recommended
 

decision based upon that.
 

DR. ANDERSON: If it goes into the program
 

correctly.
 

MR. ELLIOTT: Yes, if it all meshes together
 

correctly.
 

DR. ZIEMER: Any further questions or
 

comments of a general nature?
 

Okay, I want to look at the schedule here
 

for a minute.
 

DR. MELIUS: Can I just ask one question?
 

DR. ZIEMER: Yes, Jim.
 

DR. MELIUS: Are we going to comment on the
 

three questions? I'm a little confused
 

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procedurally.
 

DR. ZIEMER: Yes.
 

DR. MELIUS: Okay.
 

DR. ZIEMER: At least on two of them, and
 

maybe three of them.
 

DR. MELIUS: Okay, because I have some
 

comments about how we'd want to go about doing
 

that, but I think if —
 

DR. ZIEMER: Right.
 

DR. MELIUS: — you go ahead, that's fine.
 

DR. ZIEMER: I just want to look at the
 

schedule here, and just alert you we have a
 

public comment period after lunch blocked off for
 

an hour, but we will only have one person after
 

lunch who's asked for one minute. And we have
 

another one before lunch who needs five to seven
 

minutes. We actually have a third one now, okay,
 

David Richardson. We need to do at least one of
 

the public comments before lunch. We can do the
 

others then as well, with the permission of those
 

commenters if they're willing to do them earlier,
 

and then talk about how we proceed on answering
 

the three questions.
 

We have basically one presentation this
 

afternoon on dose reconstruction, and the rest of
 

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the time is then available as a working session.
 

If it's agreeable, we could go ahead with
 

the public comment period now and take a little
 

break from this line.
 

Then let me ask Robert — is it Tabon?
 

MR. TABOR: Tabor.
 

DR. ZIEMER: Tabor.
 

MR. TABOR: Tabor.
 

DR. ZIEMER: Yes, Tabor, yes. Okay, I read
 

the R as an N, thank you. Robert, are you
 

prepared to proceed? Could you use the mike in
 

the front, please? Robert's with Fernald Atomic
 

Trades and Labor Council.
 

MR. TABOR: I'll try to be as brief as I can
 

and hold it to the time limit that I indicated.
 

I have a couple of items here I'd like to share
 

with you.
 

For the record, my name's Robert G. Tabor.
 

I go by Bob Tabor. I only mention the Robert G.
 

because we have a Robert C. at the site as well.
 

I'm the only one, though, on the e-mail. I
 

appreciate the opportunity that you're giving me
 

to do this outside of your normal agenda there.
 

Let me give you just some brief background.
 

I'm a 21-year veteran at the Fernald site. I'm a
 

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journeyman millwright by trade. I've been in
 

this labor business for about the last 17 to 18
 

years, have held a number of positions throughout
 

our council.
 

And I guess I find myself mostly on special
 

assignments interfacing with a number of folks in
 

our organizations across the network, a number of
 

folks at Washington in your health and safety
 

field, which is principally — a lot of what I do
 

is associated with that. I've interfaced with
 

Dr. Neton and Grady Calhoun a number of times in
 

various types of committees or programs, or
 

things that we do at our site that involved their
 

expertise. I know a number of you folks that are
 

here.
 

I've met a number of labor folks from across
 

the country at other organizations. I've been to
 

every site, the primary cites in the nuclear
 

network, with the exception of maybe Pinellas,
 

which I believe is closed, and Weldon Springs,
 

which I believe is closed. And the only
 

operating site that I think I haven't been to — I
 

haven't been to any labs — but the only operating
 

site I haven't been to is maybe Pantex.
 

And I take a minute to give you that
 

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background because there's many of folks out
 

there like myself that have a lot of interest in
 

the things that you're doing. And I've followed
 

this program pretty much since its conception,
 

maybe not as closely as Dr. David Michaels, where
 

he mentioned he's been involved since the
 

flirtation of the idea, but have made a number of
 

trips. And I'm pleased to see that we have an
 

organized Board, and I am happy that — or I
 

should say I'd like to compliment you on the fact
 

that you've gotten this far this fast.
 

Let me step off the track here a second and
 

make a comment in the form of a question. As Dr.
 

Mary Schubauer-Berigan — I hope I pronounced that
 

correctly — as she was dissertating (sic)
 

yesterday, a thought or two came to my mind. And
 

I began to write a question that I had, more so
 

as food for thought for you folks, and I wrote it
 

down. So I'm just going to read what I wrote —
 

if I can read my own writing, that is.
 

When new methodologies or technologies or
 

better practices are discovered or employed with
 

respect to the probability of cause, determining
 

the probability of cause, and those new tools
 

help to maybe render a decision more clearly,
 

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what impact may this make on previous cases that
 

possibly a lesser accurate methodology or
 

technology may have caused a determination to be
 

negative as opposed to a favorable positive
 

determination that you might now get with an
 

updated technology, inasmuch as a decision made
 

on a case today with whatever tools that you have
 

to determine or make those decisions might be a
 

little different five years from now?
 

And as she was speaking — you learn as you
 

listen — it came to my mind that, what if? And I
 

guess as an example, if a new methodology more
 

clearly helps to render a positive decision as
 

opposed to an old methodology that may have had a
 

negative impact, what consideration will be given
 

to those previous determined cases that may have
 

been denied?
 

Now I know we've talked about there's a lot
 

of latitude designed into this program that —
 

what do I want to say? I don't necessarily want
 

to say weighs in favor of the applicant, but it
 

certainly gives some latitude there for error or
 

whatever. I think you know what I mean. And —
 

but you may have cases that are very borderline,
 

that today fall one way that tomorrow may fall a
 

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little differently under the same set of
 

circumstances for the most part.
 

So I'd like to offer that up as food for
 

thought if you haven't considered that, and what
 

that might come to as far as some decision-making
 

from the Board in the future, keeping that in
 

mind.
 

Now on a whole other note, I'd like to talk
 

a little bit about the structure of the Board.
 

As indicated, I said I compliment you on how far
 

you've gotten so fast. I certainly appreciate
 

the fact that we have a brother on the Board here
 

who is a labor type. But I'd also like to
 

piggyback some comments that Richard Miller made
 

yesterday about the structure of the Board and
 

the balance.
 

Let me put it in these words — and this is
 

not exactly criticism; it's just simply comes
 

from some experience that I've had. I didn't
 

mention the fact that I'm on the Fernald Citizens
 

Advisory Board, and I've been on that board since
 

its conception. I'm also a member of FRESH. I
 

don't know if you're familiar with that
 

organization, but that's the Fernald Residents
 

for Environmental Health and Safety. They're a
 

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public activist type of a group that follows a
 

lot of health effects, things that go on
 

throughout the country, and attend a lot of
 

meetings and are quite in tune with these type of
 

things.
 

And I also — not as a member but as a
 

participant from the audience — have attended the
 

Fernald Health Effects Subcommittee when it was
 

in session, and am following up on participating
 

in another committee to continue with some of the
 

efforts of that committee. So I have a big
 

interest in this particular area.
 

What I might say with respect to structure
 

of the Board is that if you really want to
 

optimize your effectiveness or optimize your
 

success, you really need to consider balance
 

here. And what I'm talking about is other labor
 

types on your Board. For instance, my friend
 

right here, he's a representative of the labor
 

type speaking for himself, maybe not so much for
 

his constituency, because obviously that's the
 

role that you need to play on the Board; and he
 

comes from a laboratory.
 

Most of these claims that you probably will
 

have before you are going to be claims from
 

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workers at production type of sites. Yet you do
 

not have the flavor of that element on your
 

Board. And it could be quite helpful to you
 

folks.
 

It's just a rule of thumb that I always use
 

when I'm either chairing a committee or chairing
 

a team to do something, the first thing I ask
 

myself, what is it that I'm about to do; how does
 

it — how and who does it impact? And when I
 

identify that, I be sure that who it impacts is
 

at the table for input, because it's going to
 

render my decision-making a lot more thorough so
 

I can do the right thing the first time. And it
 

certainly helps when you're — to take that into
 

consideration.
 

So I might suggest that if you have an
 

opportunity to expand this Board that you
 

consider getting some other flavors of labor from
 

some of the production facilities, or at least
 

somebody out there that's familiar with that.
 

And as the gentleman pointed out yesterday,
 

probably a lot of our sites are one of the
 

largest bodies that's represented out there is
 

OCAW, which is now, I believe, PACE, and also you
 

have the metal trades. I belong to a metal
 

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trades organization myself.
 

There's some advantages to that, and I would
 

suggest that you take into consideration a couple
 

of things. I'm sure that not just scientific
 

data may or may not factor into your decision-


making, but a lot of times operational
 

experiences may have an important role in the
 

decision-making.
 

A good example would be, in discussion with
 

a friend yesterday, was telling me about an
 

experience of one of their workers who had what
 

is referred to, I think, as a shine. There was
 

just — this person was radiated intensely and
 

developed a cancer, a malignancy that normally
 

doesn't metastasize itself in the pathway in
 

which this did. But because of that particular
 

little pinpoint zone that got radiated in the —
 

by the nature of the way they worked, it may not
 

even show in his dose reconstruction, on his
 

dosimeter.
 

Well, how do we deal with those kind of
 

cases? Those will be things I'm sure you may run
 

into. And operational experiences will be
 

vitally important to some of your decision-


making. Having someone at the table that can
 

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share in those things or has some insight could
 

be really helpful.
 

Then there's another issue I'd like you to
 

take in consideration. I come from a closure
 

site. Part of the thing that the current CAB is
 

looking at in the realm of stewardship — and I'm
 

on the stewardship committee, as well — is our
 

record-keeping.
 

Now I know Federally there are probably some
 

laws that are in place that account for how we
 

keep medical records, and those requirements will
 

— the retention of those records will be
 

protected. But there's other records out there
 

that maybe are not laws from operational
 

experiences that you may wish to say, hey, we may
 

need to look at some of these things.
 

Well, keep in mind that just recently,
 

especially at my site, there previously was a
 

moratorium on records and record retention. That
 

moratorium is being lifted. On closure sites
 

this information is going to be going away, or it
 

could go away. That may be an area that you may
 

want to consider to look into as far as
 

information that you may need in order to be
 

thorough in some of the decision-making and the
 

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processes of determining whether a claim is valid
 

or not.
 

So I present you some food for thought with
 

respect to that, with respect to the balance of
 

the structure of your committee. And let me see
 

here, in looking over my notes, is there anything
 

I've missed? I don't believe so. That's all
 

I've got to say.
 

DR. ZIEMER: Thank you very much, Bob, and
 

your remarks will —
 

MR. TABOR: Do you have any questions?
 

DR. ZIEMER: — be included in the record,
 

the transcripts.
 

Yes, are there any questions that any of the
 

Board members have?
 

[No responses]
 

MR. TABOR: Thank you.
 

DR. ZIEMER: Thank you, Bob.
 

Next we have Fay Martin, LOC/CAP. Help me
 

out, though, Fay. What is that?
 

MS. MARTIN: That's what I was going to
 

explain. I'm Fay Martin —
 

DR. ZIEMER: And she's at Oak Ridge.
 I
 

think you gave us those acronyms yesterday, and I
 

forget what they are. Sorry.
 

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MS. MARTIN: I'm Fay Martin, representing
 

the Local Oversight Committee and the Citizens
 

Advisory Panel of Oak Ridge. The LOC's composed
 

of elected and appointed officials from the City
 

of Oak Ridge and the seven counties surrounding
 

the Oak Ridge Reservation. The CAP reviews and
 

provides recommendations on DOE's decisions and
 

policies.
 

Now long, long ago and far, far away there
 

was a group called ACERER. That's the Advisory
 

Committee on Energy-Related Epidemiological
 

Research. As a member of their subcommittee, the
 

citizens — and we have been led to believe that
 

we as citizens should be involved and have input
 

into what the government is doing on our behalf.
 

So I'm just here to ask a question. Are you
 

going to have a citizens group appointed to work
 

with this Advisory Board on Radiation and Worker
 

Health? Does anybody know?
 

DR. ZIEMER: We'll let Larry answer that.
 

MR. ELLIOTT: Fay, there's distinct
 

responsibilities this Board has, and those
 

responsibilities were outlined yesterday. We
 

certainly respect the interest of workers who are
 

going to reap the benefits of this whole program,
 

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and want their participation and their
 

involvement, their observation of our work. We
 

do not deny the public that opportunity as well.
 

We encourage that. There is, however, no
 

envisioned plan or need to incorporate a citizens
 

advisory subcommittee to this body, though.
 

MS. MARTIN: Okay. It's just that I've been
 

talking to some of the citizens, and they were
 

wondering is $150,000 enough money to compensate
 

for all the suffering they've had. And they have
 

lots of questions that they'd like to bring to
 

the Board. So I think their voice should be
 

heard, also. Thank you.
 

DR. ZIEMER: Thank you, Fay. And again,
 

your comments will be in the record.
 

David Richardson has asked to speak again
 

today, and David, are you — yes. UNC Chapel
 

Hill.
 

MR. RICHARDSON: Caught me a little bit
 

ahead of time. But yeah, I'd like to again raise
 

two points, two new points.
 

The NIOSH-IREP program that we've looked at
 

— it's been up on the screen; it's kind of,
 

again, a computer black box — has as its
 

foundation a set of numbers that are coming from
 

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a study of atomic bomb survivors in Japan.
 

I think it's important to stress — and I
 

want to talk a little bit about that study as the
 

basis for this first point, again from the
 

perspective of an epidemiologist – and say
 

imagine for a second the conditions under which
 

that study began. Atomic bombs dropped on two
 

cities. There are tens of thousands of people
 

who died in the first weeks from injuries, from
 

burns, and then subsequently from infections and
 

the consequences of destruction of
 

infrastructure.
 

So I think for workers and for the public it
 

raises the question, which has been a question
 

that’s been going on for decades with the life
 

span study of atomic bomb survivors, is there
 

selective survivorship? Or putting it another
 

way, when you're studying the effects of
 

radiation on a group of atomic bomb survivors,
 

it's necessary that the effect of radiation on
 

the survivors is the same as the effect of
 

radiation in the general population you want to
 

extrapolate to. So you don't want selective
 

survivorship to bias the results.
 

As I said, this has been an issue that's
 

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been raised by a number of critics. It was
 

raised early on by the Atomic Bomb Casualty
 

Commission as a consideration, could they even
 

conduct such a study? In recent years, however,
 

there's been several papers that have tried
 

empirically to investigate this question – that
 

is, looking for evidence that selection among
 

atomic bomb survivors might bias dose response
 

relationships.
 

And of particular concern it's been the
 

hypothesis, which I think is a reasonable
 

question, are the people who survived in the
 

high-dose areas — that is, people who were close
 

to ground zero — those people who survived now at
 

least a minimum of five years to enter the study
 

— they had to be alive in 1950 — were they robust
 

people? Were they — when you have people exposed
 

— and then you can think about this in lots of
 

settings where people who receive high dose
 

radiation exposures, some people are going to die
 

and some people are going to have the
 

constitution to go on living and survive the
 

infections, the consequences of the burns — and
 

then you begin studying those people, a robust
 

group of survivors selectively picked out in the
 

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high-dose areas, as in the low-dose, the far
 

outreaching areas around Hiroshima and Nagasaki,
 

there's less selection going on because radiation
 

doses diminish with distance.
 

I would just like to draw the committee's
 

attention, then, to a series of papers that have
 

looked at that, including RERF Report 12 that was
 

published in Radiation Research in 1999. There
 

was an earlier study in Health Physics that came
 

out late in 1990. And in 2000, I believe, in
 

Environmental Health Perspectives, Stewart also
 

investigated that question.
 

So now turning to IREP, I think a lot from
 

looking at the way the IREP's dealing with the
 

problems of — and this, I'd say, primarily is a
 

question of bias, but also it's a question of
 

uncertainty – there's some question about whether
 

the study of atomic bomb survivors does have bias
 

in it. So there's questions of bias and
 

uncertainty due to selective survivorship.
 

And the IREP program's drawn heavily on NCRP
 

Document 126. And the NCRP in that paper really
 

does a good job of going through sources of
 

uncertainty in radiation risk estimates. They
 

come from the life span study, primarily focusing
 

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on uncertainty in the radiation dose estimates,
 

which I think is really valid.
 

There's a — and I would stress here again
 

for the committee to remember that unlike workers
 

who are wearing badges, the atomic bomb survivor
 

dose estimates are derived primarily — and this
 

is important to say — primarily from
 

questionnaire data. And so people who have been
 

participating in questionnaires know that there's
 

questions, aside from uncertainties about neutron
 

dose estimations and those things, questions
 

about the validity of information that people
 

give in questionnaires. That information gets
 

put into a mathematical model and generated
 

quantitative dose estimates for atomic bomb
 

survivors.
 

But so there is — IREP has adopted many of
 

the recommendations by the NCRP in Report 126 on
 

how to deal with some of the uncertainties in
 

radiation dose estimates in the life span study.
 

There's a separate section, though, in what's
 

called epidemiologic uncertainties in the life
 

span study, and here selective survival is one of
 

the issues that they raise, they address, and
 

they recognize. And in fact, they point to the
 

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Health Physics article in 1990. I believe the
 

NCRP report came out before subsequent literature
 

that's also been reported. But they conclude
 

that there's evidence that there's bias, that the
 

dose estimates from the life span study are
 

probably biased downwards because of selective
 

survivorship, but the degree of bias is probably
 

fairly small, and they go on to focus on the
 

dosimetry problems.
 

I would recommend to the committee two, at
 

least two issues for consideration. One is
 

there's a recognized small source of downward
 

bias, and that's something that could be easily
 

incorporated with using the same methodology as
 

has been used for the other sources of
 

uncertainty in the life span study.
 

The other question, though, is not just
 

bias, but is uncertainty. Here you have another
 

uncertainty factor, and it's something I think
 

the committee can bring forward. Not just that
 

the estimated degree of bias is small — and here
 

we're talking about something like ten percent or
 

— I'm not sure. For compensation purposes I
 

think those are important factors. But then
 

there's also uncertainty around that, because
 

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it's to date not adequately quantified.
 

So I'll leave that as my first point, to
 

take a look at NCRP Document 126 and consider
 

bias and uncertainty arising from selective
 

survival, which has been a point that's been
 

raised in the literature now for decades. And I
 

think the last decade has been very fruitful in
 

documenting a negative dose response,
 

particularly in the first 20 years of the A-bomb
 

study between all-cause mortality and radiation
 

dose. People with higher doses tend to be much
 

healthier than people with lower doses, and
 

that's evidence of selective survivorship in that
 

population.
 

The second point that I want to talk about
 

is a set of comments that I guess it's maybe —
 

I'm going to make comments before the
 

presentation has happened on dose reconstruction,
 

and that's given the ordering of the agenda, the
 

comments period is preceding the presentation.
 

So I'm going to base my comments on a review of
 

the handouts that are available over there on the
 

side.
 

And just — I would like to point out for the
 

committee's attention really the issue of neutron
 

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dosimetry, which I don't see, except for the
 

first slide, I don't see addressed, at least in
 

the handouts. And I would argue that it's
 

important for two reasons, the first reason being
 

the biological effectiveness of neutrons and the
 

uncertainty in the RBE factor for neutrons. And
 

I'd argue that that uncertainty's largely because
 

there's not been adequate — there's not been an
 

opportunity to do a lot of epidemiologic research
 

on the health effects of neutrons. And so
 

necessarily, these RBE factors are uncertain.
 

But the general consensus is that the biological
 

effectiveness of neutrons is relatively high.
 

The other side of that is that the dosimetry
 

for neutron exposure in the DOE complex ranged
 

from non-existent to very poor for a long period
 

of time. And it was an acknowledged limitation,
 

and it was labor-intensive work. So there was
 

limited neutron dosimetry that involved visual
 

inspection of films. And so I think that's going
 

to raise, again, an important — I think it's an
 

important issue for the committee to consider,
 

how to deal with periods where neutron exposures
 

are uncertain, and the biological effectiveness
 

of them is also uncertain.
 

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Thank you.
 

DR. ZIEMER: Thank you very much. Could I
 

ask — let's see, the RERF-12, was that the RERF
 

report? I just — getting those references. Is
 

that the '99 report?
 

MR. RICHARDSON: Yes.
 

DR. ZIEMER: And then the HP journal, do you
 

know off-hand who the author on that one was?
 

MR. RICHARDSON: It's Little and Charles.
 

DR. ZIEMER: Little and Charles, thank you.
 

MR. RICHARDSON: First initials, M.P.,
 

Little, Charles, M.W. And the title's Bomb
 

Survivor Selection and Consequences for Estimates
 

of Population Cancer Risks, Health Physics, 1990,
 

Volume 59.
 

The other — the RERF report was published
 

also in the literature under the title Non-Cancer
 

Mortality, 1950 to 1990, and Radiation Research
 

in 1999, Volume 152.
 

DR. ZIEMER: Thank you.
 

Any other questions for — sorry — for David?
 

[No responses]
 

DR. ZIEMER: If not, Roger Shaw, McCarter
 

and English.
 

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MR. SHAW: Thanks, Dr. Ziemer.
 

A couple of points. Just a little bit of
 

concern. I know that the Board, as it goes
 

forward, will look at the meshing that we're
 

having here of policy and sound science. It’s
 

something that we have to do. You can't separate
 

the two completely, especially in this type
 

endeavor. In fact, the way that the Act has been
 

written, we — there are certain policy issues
 

that are written in, and there is no changing
 

that. That's understood.
 

But I think there's a lot of room,
 

especially as we listen to IREP-NIOSH and what
 

that constitutes, and the technical bases for
 

that is very — there's a lot of complex issues in
 

there, technical issues that hopefully you'll
 

take a look at. There's very good people working
 

in that, as we've witnessed, from NIOSH and other
 

agencies through NCI, very good people working on
 

these issues. But there are many issues within –
 

just, for example, the use of that program – that
 

need to be looked at very, very closely. And I
 

would just say that we need to watch some of
 

those applications.
 

I want to mention just two things. There
 

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are new studies that go beyond where we've been
 

with the primary risk coefficient bases, which
 

have been the life span study of the Japanese
 

bomb survivors, as David Richardson has
 

mentioned. There are a number of studies that
 

are going on at DOE, et cetera.
 

There's also a study that's due out later
 

this year that many folks in this room have been
 

associated with, including Larry Elliott and Dr.
 

Richardson and actually myself, and that should
 

be coming out at the end of the year from the
 

International Agency on Research on Cancer.
 

They're a national agency for research on cancer,
 

IARC. There is a DOE, Department of Energy,
 

cohort that's part of that study. There's also a
 

commercial nuclear reactor cohort that's part of
 

that study.
 

It's a 16-country study — was 17, now 16 —
 

and it includes — it is the largest study of
 

nuclear facility workers in the world. There's
 

over 600,000 people within that cohort. Some of
 

those people, a large majority of that dose is
 

low-LET, not high-LET. There are flags for
 

internal dose. There are flags for neutron, to
 

separate people out that maybe you don't want to
 

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mix apples and oranges. But I do want to make
 

sure that you're aware. I know that Dr. Elliott
 

will make you aware of that as part of the
 

Board's activities. Hopefully that will be out
 

by the end of the year. But I do want to mention
 

that there are these issues of comparing
 

populations like Japanese bomb survivors. These
 

are actually nuclear workers, very large study.
 

The second issue I just want to mention
 

again is — I'll let it go — but the DDREF and the
 

DREF issues. We're applying it — it seems that
 

we're applying for alpha an inverse DREF of a
 

factor of four. In other words, we'll increase
 

the risk from the dose if it is chronic dose,
 

which it would be if it's internal exposure to
 

transuranics. We are going to increase that.
 

On the other hand, it seems we're moving
 

towards a DREF pretty much of one for external
 

low-LET exposure. And again, that directly
 

affects the risk. That directly affects the PC.
 

Maybe not in a one-for-one — it's not completely,
 

100 percent proportional. But there is a
 

proportion of it that does affect it, and as we
 

saw with the pie charts that we went through with
 

the program, you can see that — what the effect
 

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is to varying degrees.
 

So that's really the two points that I
 

wanted to mention. And I also say it, just for
 

the record, I'd like to say I make these comments
 

as also a Cold War veteran within DOE complex.
 

Any questions for me? Thank you.
 

MS. MUNN: I have —
 

DR. ZIEMER: Wanda has a question, Roger.
 

MS. MUNN: What's the 17th country that
 

dropped off the list?
 

MR. SHAW: Germany, and someone can help me,
 

but Germany could not get their data in on time,
 

was the last update that I have. And I see a
 

couple of nods. I can see David nodding.
 

MS. MUNN: Okay, thank you.
 

MR. SHAW: Germany couldn't get their data
 

in.
 

DR. ZIEMER: Thank you.
 

Finally we have comments by Jim Ellenberger.
 

Jim's with Pace International Union.
 

MR. ELLENBERGER: Thank you very much, Dr.
 

Ziemer. I apologize for not being here yesterday
 

during the public comment period. I had
 

requested an opportunity to speak, and I
 

unfortunately had a conflict and had to leave.
 

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So I appreciate this opportunity this morning.
 

I want to thank the members of the Board for
 

your participation in this effort. This is an
 

extremely important part of the process that was
 

established by the Energy Employees Occupational
 

Illness Compensation and Prevention Act, and we
 

have tremendous interest in this. I work as a
 

consultant for Pace International Union. I have
 

been doing that since June of last year. Prior
 

to that I served almost 30 years with the AFLCIO, and worked very closely with all of the
 

affiliates of the AFL-CIO in the enactment of
 

this legislation.
 

The legislation was very specific about the
 

Advisory Board on Radiation and Worker Health.
 

It required that the President appoint the Board
 

120 days after the enactment of the Act. And
 

obviously that didn't occur, and that has caused
 

some of the problems in terms of backing up the
 

process. And this is obviously not the
 

responsibility of this Board. You had no role in
 

that, thankfully. But it is something that you
 

have to deal with, and there are literally
 

thousands of workers who depend on your work and
 

are looking with great interest and anticipation
 

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to the outcome of this process.
 

The other requirement in the Act that my
 

brother Tabor had mentioned earlier, and I'm sure
 

it was raised yesterday, was the requirement in
 

the Act that there be balance on the Board
 

reflective of scientific, medical and worker
 

perspectives. And as I mentioned yesterday in
 

the introductions, Pace International Union is
 

the union that represents the single largest
 

number of workers in the nuclear weapons complex,
 

and it is an organization that is not represented
 

on this Board. We have made a number of efforts
 

with the Administration to try and get worker
 

representatives from the production sector on
 

this Board, and that has been unsuccessful.
 

I would like to point out a similar activity
 

that you may be aware of; I don't know. The
 

Department of Energy created an advisory
 

committee to the Office of Worker Advocacy, which
 

was also established by the Act. This committee
 

was put in place a year ago. And its function is
 

to advise the Department of Energy on the
 

application of the law, and to provide advice and
 

assistance to the Secretary when it comes to the
 

Office of Worker Advocacy in that portion, very
 

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difficult portion of the law which deals with
 

diseases that are not covered by the Federal
 

portion of the Energy Employees Occupational
 

Illness Compensation Act.
 

I happen to be a member of that committee,
 

and it's comprised of a lot of the most
 

distinguished and knowledgeable experts in the
 

United States on worker's compensation. Right
 

from the very first meeting we realized that that
 

committee lacked balance. We did not have in our
 

initial meeting any representation from
 

contractors. And we acted to advise the
 

Secretary that that shortcoming should be
 

addressed, and the Secretary did appoint
 

representatives from the contractor community who
 

now sit on the advisory committee at DOE.
 

As we proceeded with our work in that
 

committee we realized another shortcoming.
 

Particularly when you deal with state worker's
 

compensation laws — there are, as you know, one
 

for each state — and the forms of insurance
 

coverage that employers have, either self-


insurance or insurance through a state fund, or
 

insurance through commercial carriers – we did
 

not have any insurance representation on the
 

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advisory committee. And we have again made a
 

recommendation that the committee be expanded to
 

include those interests. And the Secretary is in
 

the process — Secretary of Energy is involved in
 

a process right now to expand that committee to
 

make sure that those interests are represented
 

fairly in that process.
 

So I offer that for your information and
 

perhaps your consideration. I think undoubtedly
 

the work of this committee would be strengthened
 

immeasurably, and you would gain an important
 

element of trust from the public by making sure
 

that you are reflective, as the law requires, of
 

interests that are affected by this law.
 

Thank you.
 

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

there any questions for Jim?
 

[No responses]
 

DR. ZIEMER: Thank you.
 

We are approaching the noon hour. We had
 

actually blocked off 12:15 to 1:00 for lunch, but
 

our experience yesterday was that may be pushing
 

it, particularly since we may have to go off-site
 

to get something. So we will recess at this time
 

and then reconvene at 1:00 o'clock. We'll see
 

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you then.
 

[Whereupon, a lunch recess was
 

taken from approximately 11:53 a.m.
 

until 1:08 p.m.]
 

DR. ZIEMER: We need to call the meeting
 

back to order, folks. Henry Anderson has to
 

leave at 2:00 o'clock, and we want to finish much
 

of what we do before 2:00. We won't be able to
 

finish it all, but some key things we need to
 

finish.
 

Before we do that, I'm looking for Nichole –
 

where is Martha, and where is Cori? Martha and
 

Cori aren't here. They're not out there? Okay,
 

we'll catch them. I wanted to officially thank
 

them for their work in arranging this meeting,
 

and we'll just delay that a few minutes. They've
 

done an excellent job, and we want to acknowledge
 

that and show that in the record as well — Cori
 

Homer, Nichole Herbert, and Martha DiMuzio.
 

We're going to continue at this point with
 

the working session of the Board. I'm going to
 

take my seat here momentarily, and we'll focus on
 

answering the issues that have been raised, the
 

three questions.
 

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159 

But before doing that, in talking to a
 

number of you sort of on the side, just to see
 

where you thought we were and so on, I sensed
 

that there was a lot of sentiment on the Board
 

toward acknowledging the issue of balance on the
 

committee in some way. And it would seem
 

appropriate that we do that.
 

Obviously this committee does not control
 

its own membership. That is controlled by the
 

Administration and the White House. Not even HHS
 

controls that. On the other hand, it would not
 

be inappropriate for us to reflect the need for
 

that balance that has been mentioned by a number
 

of our observers at various times here in the
 

last two days. So I've asked Roy if he would
 

prepare for us a motion that we might include in
 

our recommendations.
 

Roy, are you prepared to do that?
 

DR. DeHART: I am. I would like to put
 

before the Board the following motion:
 

The Board recommends to the Secretary of
 

Health and Human Services to urge the President
 

to provide balance to the Board's membership by
 

the addition of a nuclear industry worker.
 

DR. ZIEMER: Is there a second to the
 

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motion?
 

DR. ANDRADE: I'll second that.
 

DR. ZIEMER: A friendly amendment, could we
 

say another?
 

DR. DeHART: I can — I said the addition of.
 

DR. ZIEMER: The addition of — okay,
 

addition of another.
 

Did someone second that? I'm sorry.
 

DR. DeHART: Yes.
 

MS. MURRAY: Dr. Andrade did.
 

DR. ZIEMER: Thank you.
 

Now discussion. Wanda.
 

MS. MUNN: I guess I need to make my
 

position on this very clear. Granted, I'm a
 

degreed engineer, and I have an advanced degree.
 

And granted also that I am not a union member. I
 

nevertheless have made great effort during my
 

professional career to see that I was never in a
 

management chain, because when I received my
 

technical degree I did so so that I could be onthe-ground, hands-on kind of engineer. And
 

throughout my entire professional career, that's
 

what I did.
 

So to have me considered as something other
 

than a nuclear worker does not set well with me.
 

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I consider myself a nuclear worker. I have never
 

been management. I have — my policy-making
 

activities have always been in the civil area,
 

not in my work place. So from my perspective,
 

this Board has on it at this time one-fifth
 

constituted of nuclear workers who have not been
 

involved in management decisions and are nuclear
 

workers.
 

Now I don't know whether Rich sees me in
 

that same way or not, but that's the way I see
 

myself. And therefore I am not enthusiastic
 

about this particular proposal.
 

DR. ZIEMER: Thank you for those comments.
 

Part of this, of course, is always perception,
 

and that's what we're speaking to here.
 

Yes, Rich.
 

MR. ESPINOSA: For the record, I don't
 

believe the perception of this should be
 

union/non-union.
 

DR. ZIEMER: No.
 

MR. ESPINOSA: It should be reflected as for
 

the workers, whether you're union or not. And I
 

agree with the motion that's made, and I do
 

believe that should be amended to represent labor
 

on the next appointees.
 

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MR. PRESLEY: Dr. Ziemer, I'd also like to
 

address this.
 

I am definitely a nuclear worker, having
 

been at Oak Ridge and worked at Y-12 for 35
 

years, where I started out really as a — on the
 

bottom of the rung, and have worked myself up
 

working in all aspects, all the way up from a
 

dispatcher to an engineer, and then into
 

management and then back into the technical field
 

of it. So I feel like Wanda. I feel like that
 

I'm definitely in the category of a nuclear
 

worker.
 

DR. ZIEMER: Thank you very much for those
 

comments.
 

I might add that I suppose that probably a
 

good portion of us would be in that category at
 

least part of our career. I myself started out
 

at Oak Ridge certainly in no management position,
 

low end of the totem pole, as a worker. And I
 

don't think Roy's motion is trying to deny that
 

fact. It is, I think, an attempt to deal more
 

with the perception from outside on the
 

representation here, because most are seen more
 

as professional engineers and physicians and
 

scientists. So it's more that issue. I agree
 

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with what you say, but I think it's that
 

perception.
 

Tony.
 

DR. ANDRADE: I'd also like to add for the
 

record that I agree with your comments, that I
 

think most of us have gone through a period in
 

which we were floor engineers. I was out at the
 

test site. I did all sorts of work in my tennis
 

shoes and gloves, and I took doses just like
 

other people did. However, I would also like to
 

stress the point that Richard made, that this is
 

not really an issue about organized labor versus
 

non-organized labor.
 

I think the motion would help to address two
 

important issues. One is that we recognize the
 

fact that there are representative bodies for
 

portions of the complex that existed that had
 

single-function missions. For example, we had
 

facilities that dealt with gaseous diffusion. We
 

had facilities that dealt strictly with plutonium
 

and plutonium metal works. We had uranium
 

facilities. Those facilities are not represented
 

on the Board.
 

Richard is an excellent representative for
 

the types of laboratories that we currently have
 

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on board, and those are the national laboratories
 

like Livermore and Los Alamos, that uses a
 

spectrum of crafts to work our mechanical
 

problems at those laboratories.
 

And so from that point of view I think that
 

having somebody from those older facilities, many
 

of them that are now going into shut-down mode,
 

would be a prudent action to take. Again, not as
 

organized labor versus non-organized, but just as
 

a representative of those facilities that existed
 

and were really in full-mode production during
 

the period of time that we're looking at.
 

DR. ZIEMER: Other comments? Henry has
 

called the question.
 

Quit looking at your watch, Henry.
 

That's not a formal motion to close debate,
 

so I haven't recognized it. I want opportunity
 

for further comment before we vote on the motion.
 

Do you need to hear the motion again?
 

You want to repeat the motion, read the
 

motion back
 

MS. MURRAY: Dr. DeHart moved that the Board
 

recommend that the Secretary of DHHS urge the
 

President to provide balance to the Board's
 

membership by the addition of another nuclear
 

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industry worker.
 

DR. ZIEMER: Are you ready to vote on the
 

motion?
 

All who favor the motion say aye.
 

[Affirmative responses]
 

DR. ZIEMER: All opposed say no.
 

[No negative responses]
 

MS. MUNN: I’ll abstain.
 

DR. ZIEMER: One abstention.
 

I declare the motion approved, and that will
 

be included as one of the recommendations, then,
 

to the Secretary of Health and Human Services.
 

Thank you.
 

We actually have two items already to send
 

forward. That's great.
 

Now I'd like to have us, if we're able to,
 

to address at least two of the three questions on
 

the list. We'll deal with —
 

MS. MURRAY: I'm sorry, Dr. Ziemer. Did you
 

vote?
 

DR. ZIEMER: I voted for the motion, sorry.
 

MS. MURRAY: Okay, thank you.
 

DR. ZIEMER: The question we'll try to deal
 

with first is, one, does the proposal make
 

appropriate use — the proposal being the rule —
 

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make appropriate use of science, of current
 

science and medicine, for evaluating and
 

quantifying cancer risks for DOE workers exposed
 

to ionizing radiation in the performance of duty?
 

The other question, does the proposal
 

appropriately and adequately address the need to
 

ensure procedures under this rule — to ensure
 

procedures under this rule remain current with
 

advances in radiation health research?
 

We'll deal with those two questions. If
 

we're able to deal with the third one that we
 

were somewhat vague about before, we'll go to it
 

after that. But let's see if we can deal with
 

these.
 

As a minimum, it would be helpful if we
 

could agree on a statement or recommendation on
 

each of the two. We could have more. We could
 

have none. But if we were in a position to make
 

a statement — and more than a yes or no, does the
 

proposal make appropriate use, yes/no — I think
 

if we can develop a statement.
 

And to do that, I think rather than calling
 

for a formal motion at this point, I'd like to
 

have the opportunity for people to just surface
 

some ideas or surface your views on that first
 

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question, the extent to which this rule-making
 

makes appropriate use of current science and
 

medicine for evaluating and quantifying cancer
 

risks.
 

Yes, Jim.
 

DR. MELIUS: Given the circumstances of our
 

review, and the fact this is our first meeting
 

and the limited time period to meet and review
 

the entire procedure involved, I would like — I
 

think it would be more appropriate if we sort of
 

caveated whatever statements we make with some
 

statement to the effect that we've had very
 

limited time; that we've not done a complete
 

review of the IREP and some of the other
 

assumptions being used as part of this process;
 

that we intend to go into more detail with that
 

at future meetings, but we really have not been
 

given the opportunity, given how late we were
 

appointed and so forth.
 

And then go on from there to say something
 

to the effect that in general we're in agreement
 

with the approach that NIOSH has taken, and sort
 

of make a positive statement from there in
 

general to the extent that it's reflective of
 

these regulations, again knowing that in future
 

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meetings we would go back and discuss and talk in
 

more detail about many of the assumptions and
 

other — in fact, many of the issues that have
 

been raised in the comments on these regulations,
 

which really deal more with the model, not with
 

the application of the general proposed
 

regulation, the application here.
 

But I feel fairly strongly that we have not
 

been given — not that it's anybody's, necessarily
 

anybody's fault — but we've not been given an
 

opportunity to really fully answer that question.
 

It just — and certainly not to come to a
 

consensus.
 

Now we may have individual opinions on that
 

and had time to review it individually, but
 

certainly as a committee – and the normal process
 

for a committee, at least most scientific
 

committees or advisory committees I've been on,
 

you're presented a question, go through a series
 

of meetings, and then try to reach a conclusion.
 

And we're sort of — come to the first meeting,
 

and, well, we'll give you an extra few days if
 

you want it, but that's it. We're not even going
 

to be given another meeting, another chance to
 

meet. And I think we have to say that up front
 

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in terms of our comments.
 

At the same time, I think we can — at least
 

I feel comfortable giving support to what NIOSH
 

and the Department has done so far, to put
 

forward that the basic framework here is a good
 

one and is sound, and address that question in a
 

positive way.
 

DR. ZIEMER: Roy.
 

DR. DeHART: I agree with Jim's comments,
 

and I think a couple of sentences up front. But
 

I would then say, however, we have had the
 

opportunity to read the documentation provided to
 

us both in written form in our workbooks and on
 

the web, and that we have had technical
 

presentations and an opportunity to question
 

those who represent the technical formatting.
 

think we need to give some kind of information
 

about what we have done.
 

DR. ZIEMER: Gen.
 

DR. ROESSLER: I have a little different
 

perspective, because — probably because I work
 

with the concepts that have been presented almost
 

on a daily basis. And I have been, as I said
 

earlier, impressed with the current science that
 

the group is using.
 

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However, I do agree with your caveat. What
 

I would suggest we do is put the positive
 

statement first —
 

DR. MELIUS: That's fine.
 

DR. ROESSLER: — and then put the however
 

next, because it really protects us, I think.
 

DR. MELIUS: I think again individually
 

we've looked at this and have expertise in this
 

area and viewpoints. But if we're talking about
 

sort of a committee consensus statement, usually
 

that involves a committee process, and we just
 

haven't had time to do that.
 

We've all — I've been on committees with
 

many people here, and I know you all served on
 

other committees. And normally out of that
 

process we may have some disagreements, you learn
 

something from other members, you change your
 

viewpoints on certain things, you understand
 

things better. And that's how you come to some
 

sort of a statement or consensus, and we just
 

haven't had that opportunity here.
 

And I don't think we should — I think we
 

should make — very careful that we do say that.
 

I think we should try to — I agree, we should
 

state our comments as positively as possible,
 

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again not to find fault with anybody or whatever
 

in this process.
 

DR. ZIEMER: Go ahead, Henry.
 

DR. ANDERSON: I was only going to put a
 

statement at the end, saying that we look forward
 

to working with NIOSH, reviewing the comments.
 

And in either number one or number three, we need
 

to build in that if we have our role in the rule,
 

that then we look forward to being able to
 

(inaudible). And I think we need to recognize
 

that we'll continue to work with this, we'll see
 

the experience and review it over the course of
 

the time. And I don't want anything we say to
 

delay the thing moving forward. But on the other
 

hand, I totally agree that we haven't — we just
 

have to state that we haven't had that in-depth
 

review.
 

MR. ELLIOTT: Let me address your comments
 

and your proposal.
 

I think that would suffice for what the
 

Secretary's interested in seeing. My comments
 

yesterday, I hope were taken as I intended them
 

to be, not — that is, that we're not ram-rodding
 

this through; that in the general context that's
 

what this rule presents, the general context, the
 

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general direction that we have set for
 

probability of causation. That's what we're
 

asking of you now, is to provide your general
 

viewpoints about this rule.
 

Certainly we are going to get into a myriad
 

of details in the IREP as we proceed, and bring
 

back to you the IREP with the modifications as we
 

make them, as we change them per public comments
 

and subject matter expert comments. And you'll
 

have time at that point to get far more ingrained
 

in the details and the complexities of the
 

technical aspects of IREP, as you will the
 

technical guidelines that will support the dose
 

reconstruction rule.
 

So all we're asking for February 6th is on
 

the surface of these two rules, these two draft
 

proposed rules, give us your general comments
 

with regard to their direction and what limited
 

amount of substance they present to you. Does
 

that clarify anything, or does that help give you
 

a sense you're on the right course?
 

DR. MELIUS: That's what I was saying, also.
 

I mean, the pressures are the pressures of a
 

delayed appointment of the committee, and there
 

was a change in administration and might have
 

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been expected. And secondly, the fact that there
 

is a need for the program to move on, and we
 

don't want to needlessly delay people or
 

inappropriately delay people from getting
 

compensation because of this.
 

And frankly, if I thought that waiting a
 

week or whatever it would be to the next meeting
 

would substantially change what our comments
 

would be, then I think I would certainly suggest
 

that, but I don't. I think we can reach an
 

agreement on — a consensus on a general statement
 

before — without the need for another meeting.
 

And frankly, whether a week one way or the other
 

would make much difference, I don't think so,
 

because I think you can busily work on the final
 

reg anyway.
 

But I just don't think we would change our
 

opinions much by — or have done enough, had
 

enough committee meeting time to really go into
 

the detail that could be implied by that. And I
 

think it's a little confusing, because many of
 

the comments we're getting from the outside and
 

some of your expert review have to do with the
 

details, not with the general regulation. And I
 

don't imply whether we agree or disagree with all
 

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those comments, but we'll have more time to spend
 

on that as a committee. And given their
 

technical nature, that's probably more
 

appropriate.
 

DR. ZIEMER: Thank you.
 

Any other feedback? I think I'd like to
 

reach a point where we feel like we all sort of
 

agree on the nature of the statement. Then it'll
 

have to be drafted, crafted or drafted or both,
 

so that we have specific words to react to. But
 

if there are views that are sort of contrary to
 

what already has been here or a somewhat
 

different direction, I'd like those as well. I
 

don't want to interpret any silence as being
 

necessarily agreement. If you feel the urge to
 

say that none of that makes sense, here's what we
 

ought to say, then let's hear it.
 

[No responses]
 

DR. ZIEMER: I don't hear strong objections
 

to what's already been put forth. I'm not asking
 

for any votes at this time. I think what we'll
 

do is take this, and we'll have a working group
 

craft it into words, and probably will not
 

finalize it until our phone call because Henry's
 

going to be leaving here before we know it —
 

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DR. ANDERSON: We didn’t talk about giving
 

(inaudible).
 

[Laughter]
 

DR. ZIEMER: Well, I think we did.
 

UNIDENTIFIED: Henry has a lot of time on
 

the airplane this afternoon to write this.
 

DR. ZIEMER: That's your assignment on the
 

way home.
 

[Laughter]
 

DR. ZIEMER: Okay, so we have sort of a
 

framework for answering the first question.
 

Richard.
 

MS. MURRAY: Would it be helpful if I read
 

you the notes of what I took of what people said
 

to see if you could develop something now, or do
 

you —
 

DR. ZIEMER: I don't want to sit here and
 

craft it now, but we'll use those notes later to
 

actually do the crafting. I don't want us to try
 

to compose right now. I just want to sort of get
 

a sense of the Board.
 

Was there another comment? Do you have a
 

feel for sort of that's sort of the framework or
 

the ball park for the first statement?
 

[No responses]
 

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DR. ZIEMER: Let's go to number three, does
 

the proposal appropriately and adequately address
 

the need to ensure procedures under this rule —
 

to ensure that procedures under this rule remain
 

current with advances in radiation health
 

research? Any comments on that one?
 

DR. MELIUS: I would just say that I think
 

we can combine that into a single statement for
 

both — of general support for number one and
 

three, so to speak, that would just be an
 

additional sentence or so to that, rather than
 

try to start all over again, have two statements.
 

DR. ZIEMER: That could certainly be done.
 

Are you confirming, though, that you agree that
 

there is a level of adequacy that you are
 

comfortable with?
 

DR. MELIUS: Yes.
 

DR. ZIEMER: Henry.
 

DR. ANDERSON: And what I was suggesting is
 

we take the very first proposal that we did, and
 

say — and that would — it would be strengthened,
 

were there to be a clear role for the Board
 

written into the rules.
 

DR. ZIEMER: In other words, move that —
 

this part of the recommendation, the thing we
 

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I 

already approved this morning. Right?
 

DR. ANDERSON: Yeah, because the — yeah.
 

would think the Board's role would strengthen if
 

you could be assured that —
 

DR. ZIEMER: Certainly strengthens the
 

change issue.
 

DR. ANDERSON: The change issue. That's the
 

hook I would suggest we put in.
 

DR. ZIEMER: Other comments?
 

[No responses]
 

DR. ZIEMER: Does that silence mean, again,
 

agreement, or did you have a big lunch and I need
 

to rap the gavel?
 

DR. MELIUS: Anybody that speaks too much
 

will get volunteered for this.
 

DR. ZIEMER: Those who didn't speak will be
 

on the working group. Right?
 

Okay, so as I'm hearing it now, the
 

framework would be one broad statement that would
 

cover both questions, as well as the issue of
 

moving that — those comments into the rule-making
 

part.
 

Boy, we're just moving ahead here so rapidly
 

I'm going to have to start speaking slower to
 

stay on schedule.
 

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Does the proposal appropriately adopt
 

compensation policy as it's been applied? Now
 

this is that issue of the adopting — not
 

adopting, more adapting, I guess — adapting the
 

veteran's proposal to this application. Does the
 

Board wish to speak to that issue, And if so how?
 

You have the document, the veteran's thing, now
 

before you.
 

DR. MELIUS: One question, and you may have
 

stated this morning — maybe Larry or who can
 

answer this — but have you received any comments
 

on this question? Has anybody commented on
 

question number two? I don't recall any, but I —
 

MR. ELLIOTT: Ted, you want to help us out?
 

Ted has been working on reacting and thinking
 

about how we're going to address the comments, so
 

—
 

MR. KATZ: We did — I think we just received
 

one comment on this.
 

DR. ZIEMER: There was only one person that
 

understood what the question was.
 

MR. KATZ: No —
 

DR. ZIEMER: It would be helpful for the
 

committee.
 

MR. KATZ: And actually, and the comment was
 

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actually along the lines of how this committee
 

has responded, which was they're not sure what —
 

it was a bit unclear to them what the metrics
 

were, and what the advantages and disadvantages
 

of adapting VA policy were, as well.
 

MR. ELLIOTT: If I may, I think what this
 

really gets at is have we taken the right steps
 

in what we've learned from the VA's experience in
 

making changes or modifications in our rule, as
 

well as the IREP that will be used in this rule,
 

to — that are — those modifications that are
 

appropriate and applicable to the work force
 

under this compensation program. That's what I
 

think we're after here. Are we doing the right
 

thing, learn — building upon learned experience
 

from the VA, and making changes appropriately for
 

this work force.
 

DR. MELIUS: The committee finds no
 

evidence that you have —
 

MR. ELLIOTT: No evidence that we've done
 

that?
 

DR. ZIEMER: No, no evidence that you
 

haven't done it correctly.
 

UNIDENTIFIED: However, a caveat —
 

DR. ZIEMER: Well, this is one of those
 

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questions, I suppose, where the proof is in the
 

pudding, as the old saying goes. You don't
 

really know till you see the outcome. But would
 

it be appropriate if we included a phrase or two
 

that said that as best we can determine it
 

appears that they are — because this has to do
 

with direction, that this rule appears to be
 

appropriate for the DOE work force for whom it's
 

focused, something to that effect.
 

DR. MELIUS: Yeah, certainly I think we can
 

say that NIOSH has considered a number of factors
 

for this — the DOE work force would differ or
 

program should differ for the DOE work force than
 

for that covered under the VA program, and appear
 

to be appropriately taking those factors into
 

account. And if you go through the rule,
 

particularly under the — they talk about
 

uncertainty issues and some of the scientific
 

issues, some of the parentheses, the examples
 

they use, I think, are evidence of that. They're
 

just issues that wouldn't come up in — for the VA
 

rule.
 

DR. ZIEMER: Wanda, please.
 

MS. MUNN: We can either make a very bland
 

statement along the lines that we're talking
 

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181 

about, or we could use this as an opportunity, if
 

this body feels it's appropriate, to point out
 

that there's an enormous difference between the
 

two types of compensation. As best I understand
 

the compensation in the Veterans Act, all one had
 

to prove is that they were there at the time and
 

have one of these cancers, and they were then
 

compensated.
 

What we have before us here is an effort to
 

face the reality that simple exposure to
 

radiation does not automatically assume the
 

development of disease. I don't know of any
 

other place in this particular rule where we
 

would have an opportunity to make that kind of
 

statement, but it appears appropriate to me that
 

we would be wise to make that distinction in our
 

comment, and again applaud NIOSH for the efforts
 

that have gone into identifying and reducing the
 

uncertainty in making these kinds of decisions.
 

DR. ZIEMER: Good point, opportunity to make
 

– let me get some reaction to that from around
 

the table.
 

UNIDENTIFIED: We have a comment from Ted.
 

DR. ZIEMER: Ted has a comment here.
 

MR. KATZ: Can I just clarify? They do
 

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182 

actually, with the atomic veterans, they do dose
 

reconstructions, and they do calculate
 

probability of causation. Does that —
 

MS. MUNN: In some.
 

MR. KATZ: Excuse me? Okay, I'm sorry.
 I
 

just —
 

DR. ZIEMER: Okay. Any other reflections on
 

the point that was just made? Sally.
 

MS. GADOLA: I have a question.
 

When I initially read this, I had the
 

impression that it was the spirit that was behind
 

Congress when they enacted this – and maybe I'm
 

wrong – but to me it seemed like because this was
 

dealing with the Cold War veterans, the people
 

that were working in the nuclear plants, that
 

this was one of the reasons that this was also
 

included and this was used as a guideline — not
 

just the scientific, technical aspect, but I felt
 

that there was also an aspect that dealt with the
 

spirit and the reason for it.
 

And maybe that should also be addressed.
 

Maybe also we have some comments or some of our
 

experts have some comments on that.
 

DR. ZIEMER: Okay, thank you.
 

Do we have any reflection on either of the
 

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comments that Wanda or Sally made?
 

[No responses]
 

DR. ZIEMER: Okay. Thinking about it. Yes,
 

Tony.
 

DR. ANDRADE: I want to ask a question of
 

Larry.
 

When was the Radiation Exposure Compensation
 

Act passed?
 

MR. ELLIOTT: October of 2000.
 

DR. ANDRADE: October, 2000.
 

MR. ELLIOTT: Oh, RECA. You're — RECA,
 

Radiation Exposure Compensation Act.
 

DR. ANDRADE: Right.
 

MR. ELLIOTT: I'm sorry. It was 1990, ten
 

years before the one I just mentioned.
 

DR. ANDRADE: Right.
 

MR. ELLIOTT: I'm sorry.
 

DR. ZIEMER: Now we — let me see how we're
 

doing on time. It's quarter to 2:00.
 

I am going to ask for a few volunteers to be
 

a working group to put some words together.
 

Wanda, would you be willing to put together
 

the words that express the idea that you surfaced
 

—
 

MS. MUNN: Certainly.
 

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DR. ZIEMER: — a couple of sentences? And
 

then let me ask for one or two volunteers to —
 

and this is not going to be lengthy — to put
 

together the sentences on — which will be sort of
 

one or two paragraphs on the other issues. Jim.
 

Do we have one other person?
 

DR. ANDERSON: If it isn't today, I'll help.
 

DR. ZIEMER: Well, first attempt is going to
 

try to be today, Henry.
 

Notice how free he was to volunteer, knowing
 

he would be leaving shortly.
 

Okay, Gen Roessler.
 

DR. ROESSLER: Well, I have to leave kind of
 

like at 4:00 o'clock —
 

DR. ZIEMER: No, no, no. We want this all —
 

DR. ROESSLER: — but I'd be glad to work
 

with Jim.
 

DR. ZIEMER: All we want is just an early
 

rough draft. We will not act on it today. We'll
 

act on it by — on our — February 5th. I think
 

I'd like if — and see if you agree with this —
 

I'd like to sort of see what we have before us,
 

and then you can have something to take with you
 

and mull over between now and then. And we will
 

have some chance to polish in between by e-mail
 

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exchange before we get to the final product, so
 

everyone will have a chance for input. I just
 

need two or three people. So we actually have
 

three, with Wanda's main assignment being those
 

sentences dealing — Tony, did you volunteer?
 

DR. ROESSLER: He's good at words.
 

DR. ZIEMER: Gen just volunteered you.
 

DR. ANDRADE: Thanks, Gen. I can work with
 

Wanda.
 

DR. ZIEMER: What I'd like to do is take
 

about a 15-minute break right now, allow you
 

three or four to sit in the corner and do that.
 

And then at 2:00, once Henry's gone –
 

DR. ANDERSON: Okay, rub it in.
 

DR. ZIEMER: We're scheduled at 2:00 o'clock
 

to have Dr. Neton's presentation on the technical
 

guidelines for dose reconstruction. And we'll
 

have a little — we have another session — we have
 

some time after that, at which time we might look
 

at this early draft. And that would pretty much
 

complete our agenda at that point.
 

DR. MELIUS: Are we going to go through,
 

comment on dose reconstruction?
 

DR. ZIEMER: We'll have an opportunity to —
 

to work — to do comments on dose —
 

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MR. ELLIOTT: Yeah.
 

DR. ZIEMER: My understanding is that's not
 

quite as urgent. Is that —
 

MR. ELLIOTT: Well, we still have the same
 

public comment period, and then keeping the
 

record open till February 6th for the dose
 

reconstruction comments. But by statute, what
 

we're forcing to happen here is your comments
 

need to be in place in the docket on probability
 

of causation. That's a responsibility this Board
 

has before we can finalize that rule. We can
 

proceed and react on our dose reconstruction
 

comments as we take you through the technical
 

guidelines, okay? And if we have to reopen the
 

record for that to — you see, we've asked you to
 

look at the dose reconstruction guidelines.
 

You're required to look at the POC rule.
 

DR. ZIEMER: By statute.
 

MR. ELLIOTT: By statute. And we chose to
 

ask you to look at dose reconstruction. So what
 

we're trying to force here is your comments into
 

the record on probability of causation.
 

DR. ZIEMER: And that's the priority.
 

MR. ELLIOTT: That's the priority. If we
 

don't get through that on dose reconstruction,
 

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we'll just proceed as we can to get those in.
 

But —
 

DR. MELIUS: Can you reopen the record,
 

though? That's —
 

MR. ELLIOTT: Yeah.
 

DR. MELIUS: Okay.
 

MR. ELLIOTT: We can reopen the record.
 

DR. MELIUS: I'm not sure it's necessary,
 

but it may be.
 

MR. ELLIOTT: I'm not sure it's necessary on
 

that, but it is necessary on a legalistic
 

viewpoint that we have the record open for you to
 

comment on POC.
 

DR. ZIEMER: We'll take a 15-minute recess
 

as a full committee, ask the working group to
 

pow-wow, and see what you can put together.
 

[Whereupon, a brief recess was
 

taken from approximately 1:50 p.m.
 

until 2:05 p.m.]
 

DR. ZIEMER: I'd like to call the committee
 

back to order again, or the Board back to order.
 

Just before we resume our deliberations,
 

it's a good point in our meeting to formally
 

recognize the work of three individuals who were
 

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instrumental in doing all the ground work and
 

arrangements for this meeting — Cori Homer,
 

Nichole Herbert, and Martha DiMuzio. And here
 

they are over here, and let's thank them.
 

[Applause]
 

DR. ZIEMER: Very well done, ladies, and
 

you've set a high bar for future meetings to be
 

right up there like this. This is great. Thank
 

you very much.
 

Now the working group reports to me that
 

they have the wording really all ready, but
 

they're not going to share it with us today.
 

They actually are going to e-mail it out, get
 

some final word-smithing. But I understand they
 

have pretty much agreed on what they think we
 

should look at, but are not ready to sort of
 

distribute it yet. So that will occur — and Jim
 

is going to handle that. That's going to happen
 

like the minute you get home, right?
 

DR. MELIUS: Not — the minute I get back to
 

the office tomorrow morning.
 

DR. ZIEMER: Okay. It will happen soon, and
 

—
 

DR. MELIUS: It will happen tomorrow
 

morning, and then —
 

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DR. ZIEMER: And then —
 

DR. MELIUS: — we should set a schedule.
 

DR. ZIEMER: — we'll each have an
 

opportunity to actually look at that and provide
 

some feedback. Let's agree to provide feedback.
 

Jim, again, if you would collect that and then
 

develop the final wording for us to use in our
 

conference call. Okay.
 

Any questions on that?
 

Yeah, Larry.
 

MR. ELLIOTT: And the conference call is
 

February 5th at 10:00 a.m. Eastern Standard Time.
 

DR. ZIEMER: Correct.
 

MR. ELLIOTT: And the purpose of this call —
 

we have to have a purpose when we announce it in
 

the Federal Register.
 

DR. ZIEMER: The purpose will be to approve
 

the recommendations to be forwarded to the —
 

MR. ELLIOTT: Secretary.
 

DR. ZIEMER: — Secretary of Health and Human
 

Services.
 

DR. MELIUS: Can you move that time? I'm
 

giving a talk at that —
 

MR. ELLIOTT: We can move that time if it's
 

the pleasure of the Board. You tell us what
 

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time.
 

MS. MUNN: As long as it's later and not
 

earlier.
 

DR. ZIEMER: Do you have a conflict at that
 

hour? Is that —
 

DR. MELIUS: I'm giving a presentation —
 

DR. ZIEMER: Oh, well, I —
 

DR. MELIUS: — at that very moment.
 

MR. ELLIOTT: How does 1:00 p.m. Eastern
 

Standard Time sound for everybody? And we'll let
 

Dr. Anderson know.
 

DR. ZIEMER: Okay, so pencil that in for
 

1:00 p.m. Eastern Standard Time, then. Thank
 

you.
 

MS. HOMER: 1:00 to 3:00?
 

MR. ELLIOTT: You want 1:00 to 3:00, or —
 

and then we can — if we don't need the two hours
 

—
 

DR. ZIEMER: Block it off 1:00 to 3:00. If
 

we don't need the full time, we won't use the
 

full time.
 

Now we're going to hear from Jim Neton
 

again, and he's going to talk about the dose
 

reconstruction. Here he is.
 

Jim, please.
 

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DR. NETON: Good afternoon. I'm here to
 

flesh out a little bit in somewhat more detail
 

our approach to dose reconstruction under 42 CFR
 

82, which is a little shift in gears from the
 

probability of causation, PC rule discussion
 

we've had thus far, which is the priority of this
 

meeting. But I'd like to try to lay the
 

groundwork for some future discussions at
 

meetings that are upcoming related to dose
 

reconstructions today.
 

So with that being said, let's see if I can
 

get this thing fired up there. So this is —
 

there is some redundancy built in here, partly
 

intentionally, just because the concepts are the
 

same. And like I said, in some cases I'm going
 

to elaborate a little bit more on the concepts,
 

and some places I'm just going to provide what I
 

believe to be some reasonable examples that might
 

help solidify in people's minds the groundwork
 

for the approaches we are taking.
 

I mentioned yesterday that we do have our
 

draft technical guidelines issued. I am
 

reviewing them now. I'm in the unfortunate
 

position at this point that the people in my
 

group are cranking out work faster than I can
 

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read it, which is good, I guess. But by the time
 

the Board convenes next time, we should have
 

those draft guidelines available for review. Now
 

that I've committed to it, I can see Grady is
 

shrinking in his seat.
 

I'm going to start with external dosimetry,
 

primarily because it's somewhat of the more
 

analytically straightforward process. Internal
 

dose, as we'll see, and for those of you who have
 

been involved in internal dosimetry as a hobby or
 

a career, we'll see there's much more art
 

involved in that process. So I'll take what I
 

believe to be the easier approach to explain.
 

can get warmed up at least with the external.
 

Not to demean anyone's intelligence in the
 

room, but I'd like to talk about what we mean by
 

external dose in terms of what we're talking
 

about for compensation, and it's of course dose
 

received from outside the body. But we do have
 

to consider both what we consider a deep dose, a
 

dose to the organs that are within the body that
 

are radiated, as well as the surface dose, the
 

skin dose, because as we're seeing already, a
 

skin cancer is a fairly common form of cancer.
 

And indeed a number of the claims that we've
 

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received already are presenting with skin cancer.
 

In fact, much to my — not surprise, but I guess I
 

was a little bit surprised to see the number of
 

multiple primaries — you know, that formula that
 

we talked about early on for the PC rule. It's
 

not out of the ordinary to see a skin cancer
 

coupled with a future solid tumor down the line.
 

So we do need to concern ourselves with how skin
 

dose is calculated.
 

Three primary sources — gamma and
 

X-irradiation, photons and X-rays; neutrons are
 

definitely a source of exposure in the DOE
 

environment at many sites, and is something that
 

we are taking a long, hard look at, and I will
 

address that a little later in the presentation;
 

and beta particles, which are primarily from an
 

external exposure perspective only relevant for
 

skin dose. Anything greater than one centimeter
 

deep in the body, any irradiated tissue would not
 

be exposed to the energy deposited by a beta.
 

And for purposes of compensation and in
 

general for radiation protection, alpha radiation
 

is not considered as a source of external
 

exposure, although one can argue for certain —
 

the average range of an alpha is about 50 microns
 

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in tissue, so it's not going to get down to
 

what's considered to be the 70 micron depth of
 

the basal cells of the skin that would be of
 

significance for the generation of skin cancer.
 

There are some higher energy betas from
 

(inaudible) case here is I think there's an 8.78
 

meV beta that I'll take a look at, just to make
 

sure we're not missing something there. It may
 

actually get down to 70 microns. Okay.
 

As we view it for compensation purposes,
 

there are four components related to external
 

dose that we need to at least evaluate for each
 

claim, and those are listed here: The measured
 

dosimeter dose, which we talked about yesterday,
 

the dose that the film badge or the TLD badge
 

receives, and some conversion that's required to
 

convert that into an organ dose for the cancer
 

that the claimant presents.
 

And then the missed dose, which we're going
 

to talk a little bit more about today, which is
 

the undetected dose that one needs to add back
 

into a claimant's dose to ensure that we've
 

adequately covered what his potential exposure
 

was in somewhat of a realistic fashion. I mean,
 

we're not going to blindly go back in and add
 

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doses without doing some sanity checks here.
 

Occupational environmental dose is another
 

area where, when it's possible and when
 

available, we would like to consider the
 

environmental exposure. And what I mean by that
 

is exposures to workers who were not necessarily
 

monitored in the plants, but just generally in
 

the vicinity of the plants. This would be
 

emissions from the stack that, whether it's
 

particulate or noble gases that have photons
 

emitted, it would irradiate the workers. We need
 

to consider that. And this is particularly for
 

people who were never monitored. There is a
 

small component — I have an example later of what
 

we mean by that.
 

And I talked yesterday about occupationally
 

derived medical dose, which is these required
 

medical X-rays. So the simple algebraic equation
 

on the bottom is a total dose, is the summation
 

of those four different types.
 

The hierarchy of external exposure, I talked
 

about this yesterday. The personal monitoring
 

film badge or TLD, we would put highest priority
 

on using once it was evaluated for its adequacy
 

for the monitoring program involved.
 

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Pocket ionization chambers that were
 

typically used at facilities that could — the
 

little pencil dosimeters that people wear, they
 

would wear in conjunction with a film badge
 

typically. But those would be read on
 

essentially on a daily basis, where you would go
 

into a area, zero it, look at it and record your
 

dose in some kind of a log book later on. Those
 

are useful for establishing ranges, although
 

their energy dependence is suspect, and we need
 

to take a very hard look at that if we're going
 

to use them for anything other than high energy
 

penetrating gamma.
 

Group dosimeters also have been issued
 

historically in the past, and that would be
 

people who were working in a similar exposure
 

environment. Historically in the past they would
 

pick one person as representative of the group,
 

and monitor — and look at the group's dose based
 

on that.
 

And then we get into the work place
 

monitoring, the area ambient air surveys. That
 

shouldn't actually be air surveys for external
 

exposure. Ambient area surveys is what's meant
 

there, which is the general — the radiological
 

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technicians will go out and map out an area to
 

create a radiation work permit, or something to
 

that extent.
 

And then the last in all of these is the
 

source term analysis, which is — a simple example
 

is if you have a point source of cesium 137
 

sitting ten meters away and it has so much
 

activity, one can calculate what the bracketing
 

range of exposures might be in that environment.
 

And we can do some calculations using a computer
 

program such as Micro Shield or something like
 

that to come out with some estimates of dose
 

using source term analyses.
 

Okay, I went over a simpler example for
 

external dose yesterday, but I'd like to talk in
 

a little more detail. This is a Hanford worker
 

exposed from 1/3/51 to 12/19/51, so I think we
 

have a dozen reads throughout the year. And
 

these happen to be non-zero doses, so we're not
 

talking about dealing with missed dose here.
 

We're talking about things that were above the
 

detection limit, the stated detection limit of
 

the monitoring device, at least. And if we
 

accept this monitoring device, particularly in
 

the shielded window, which is the deep dose
 

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equivalent on this dosimeter, these would be the
 

readings that we'd be concerned with for looking
 

at a dose to the organ.
 

We've taken and estimated the laboratory
 

uncertainty for this, and essentially this was
 

done based on an evaluation of what the Defense
 

Threat Reduction Agency is doing in their
 

program. The monitoring devices used back in
 

this 1951 time frame are very similar in nature.
 

This was a film badge packet that had similar
 

filtration and properties and processing
 

techniques. So our estimated uncertainty is
 

about 14 millirem in this range of these deep
 

dose equivalents, and the worker, if you add up
 

all of his positive results, ends up with a 415
 

millirem total dose for that monitoring year.
 

If we take each of these 14 millirem and we
 

run it through a Monte Carlo simulation program
 

such as Crystal Ball — there's a number of
 

commercially-available products out there — we
 

could actually generate an uncertainty
 

distribution about that. This is a fairly simple
 

case. One could argue that we should just
 

propagate the errors and come out with the
 

estimated uncertainty, but you'll see as we —
 

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later on this is going to be folded into the
 

larger error structure of the external dose.
 

So if you put in each of those doses into a
 

Monte Carlo program, add them up, and then each
 

time sample this uncertainty distribution, you
 

end up with essentially a probability density of
 

what the potential doses were for that worker for
 

that monitoring year. And you can see in this
 

case the central tendency estimates, since this
 

is normally distributed, the mean is 415
 

millirem, and at the 95th percent confidence
 

interval the dose could have been as high as 513
 

millirem.
 

If this was the only uncertainty that we had
 

about a person's exposure, this is what would go
 

into the IREP program. It's a fairly simple
 

example, but there's going to be more to it than
 

this. But if this were the only uncertainty,
 

this would exactly be it. We would input into
 

IREP for 1951, high energy gamma, 415 millirem
 

with a standard deviation of down here, 50
 

millirem, and that would be sampled as such.
 

Okay. The missed dose again — and that was
 

for a person that has complete monitoring
 

history. Now we need to talk a little bit about
 

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how we're going to handle the missed dose. I'm
 

going to talk a little bit more technical detail
 

of how that's going to be.
 

Yes, sure.
 

DR. ANDRADE: Excuse me, did you mean 99
 

percent?
 

DR. NETON: Actually, yeah, it's confusing.
 

For some reason we calculated for 95, and yeah,
 

it would be — well, in IREP you put in one
 

standard deviation, so this would be actually two
 

standard deviations. It would be half of that
 

which would go into IREP, right. It's one sigma
 

is 67 percent confidence interval, two sigma is
 

95. So I probably should have been a little more
 

consistent with the input on that. It's good
 

catch, thank you.
 

The missed dose, of course I talked about
 

yesterday, can be significant when the frequency
 

of exchange was great and a relatively high
 

detection limit. For instance, 30 millirem, .3
 

millisieverts, is not uncommon in the 1950s for a
 

number of sites, and with a 52-week badge
 

exchange, if a person works 50 weeks you end up
 

with something like one and a half rem.
 

In the area of neutrons it's even much more
 

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significant than this. We've seen detection
 

limits for neutron monitoring. In the area of
 

neutron monitoring we've seen at the — I don't
 

want to pick on Hanford; we happened to look at
 

that data in somewhat more detail than other
 

sites so far — 80 millirem detection limit with a
 

50-week — a weekly badge exchange. There’s a
 

very large potential missed dose there. We're
 

not suggesting that is the missed dose, but we
 

need to take a long, hard look at that and
 

determine what the exposure conditions really may
 

have been.
 

DR. ZIEMER: Jim?
 

DR. NETON: Yes.
 

DR. ZIEMER: Question. Many facilities have
 

a formal procedure for establishing missed dose —
 

interview the person, check — as a standard
 

operating procedure, and then they enter a number
 

into the record at the time. If you go back and
 

find those, does your group intend to accept the
 

missed dose values that are established at the
 

time, or will you still try to go through another
 

procedure?
 

DR. NETON: Okay. I think —
 

DR. ZIEMER: Or do you know yet?
 

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DR. NETON: Well, yes and no. I think
 

there's two separate issues going on here. When
 

I'm talking about missed dose, I'm not talking
 

about a missed dose in which a worker, for
 

instance, claims that he did not wear his badge —
 

DR. ZIEMER: Oh. You're just talking about
 

the —
 

DR. NETON: The undetected dose —
 

DR. ZIEMER: — limited detection part of it.
 

DR. NETON: It's the design of the
 

monitoring program in general, when I say missed
 

dose. The other dose is unmonitored dose or some
 

incident dose.
 

DR. ZIEMER: Thank you.
 

DR. NETON: But the answer to that question
 

is we intend to interview the claimant, and where
 

his assertions seem reasonable and cannot be
 

refuted by other evidence, we would accept the
 

claimant's assertions. We've seen a couple of
 

cases already that there are some — it's going to
 

happen. There's no doubt about it.
 

But we need to do a check on it and make
 

sure that, for instance, if someone claims that
 

they were over-exposed to plutonium in a
 

facility, and the records indicate that that
 

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plutonium did not exist at that facility until
 

ten years after that incident, then we would have
 

to question the veracity of that statement. So
 

there are certainly what I call sanity checks one
 

needs to do on this stuff. But it's going to be
 

a difficult process to go through each of these,
 

for sure.
 

For current day periods, it's relatively
 

insignificant with modern day programs. Typical
 

missed doses are less than 40 millirem a year, .4
 

millisievert. So we don't expect — we will
 

certainly consider it and put this, add this back
 

into the monitoring record, but it's not going to
 

be anywhere near as large.
 

And I've got a couple of examples here I
 

talked about. Missed dose can be one and a half
 

rem for early time periods — which is
 

interesting, ten percent of the occupational
 

limit in the 50's, and now it's down to about two
 

and a half percent of the current limit of five,
 

which was in the 70's. So it's come way down.
 

The technology has improved tremendously over the
 

time.
 

Again, critical components, we've talked
 

about this: The limit of detection, number of
 

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badges. The central tendency of the distribution
 

is going to be estimated, as I indicated, using
 

this limit of detection divided by two
 

methodology, which is fairly standard
 

nomenclature in the literature for estimating
 

missed dose.
 

We do intend, though, not to assume that
 

this is a normal distribution, but our experience
 

base with worker data, particularly some of the
 

data that exists in the Health-Related Energy
 

Research Branch's files, indicates that a
 

lognormal distribution is more appropriate to the
 

distribution of these data.
 

So if we take a similar worker who was
 

exposed between '54 and '61, the limit of
 

detection — and he had a certain number of zero
 

doses recorded — 32, 52, 50 on his annual
 

summaries — if we can obtain these. Now this is
 

assuming we can obtain this information. The LOD
 

over two is such, and then the LOD is, of course,
 

twice that. But what I'm trying to indicate here
 

is that we are going to assume that the 95th
 

percent confidence level is the LOD. We've seen
 

this time and time again, that the LOD over two
 

in most circumstances is a biased estimate high
 

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for the worker's exposure. And we believe that
 

the LOD is a fairly decent handle to fix the
 

upper limit of the possible exposure for that
 

monitoring period.
 

So one can establish, based on those
 

parameters, some lognormal distribution of the
 

missed dose — frequency distribution of the
 

missed dose in this particular case. And we see
 

here that the geometric mean would be 210
 

millirem with a 95th percent confidence interval
 

out at 4.2 millisieverts. So for this worker's
 

range of exposures, he had no positive badge
 

results whatsoever during these monitoring
 

periods, but we would estimate and input into his
 

IREP — input into the IREP file that would be run
 

for probability of causation a geometric mean of
 

210 millirem to account for the possibility that
 

he was exposed, or he or she were exposed to that
 

level, and put in a geometric standard deviation
 

based on the methodology I just described.
 

I'm real close to these analyses, so if I'm
 

not clear, please speak up.
 

Okay, the next area I'd like to talk about
 

is the environmental dose area, where it's
 

unmonitored dose received from stack emissions
 

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typically at sites. And it can be significant in
 

the early years. Again, as the technology and
 

exposure limits and air monitoring standards
 

decreased, it's not as much a problem in the
 

current days.
 

But in early years when production for
 

weapons was high, they would do what they called
 

green fuel runs, which is instead of allowing the
 

fuel to decay for the short-term decay products
 

to go away, they would essentially start
 

dissolving these things fairly early to extract
 

the desired material, whether it was plutonium or
 

whatever. And that would result in a much higher
 

emission of fission products, the iodines and the
 

xenons, those kinds of materials that are
 

present. A short half-life, but fairly
 

significant dosimetrically shortly after
 

production.
 

And we do view this for some groups of
 

workers, such as construction workers, to be
 

maybe their primary source of exposure. If a
 

person's working out in an area of the plant
 

where there is no monitoring, it's not considered
 

a radiological area, this indeed may be their
 

only source of exposure, albeit in most cases
 

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fairly small, but certainly need to be examined.
 

Here's an example of some real data that we
 

managed to pull out of the records from — again,
 

I'll pick on Hanford here — in 1947. The area —
 

this is a diagram of the Hanford facility or
 

site, and you can see the 100 area, the 200 area,
 

the plutonium processing areas. The doses in
 

white here — don't let the units confuse you.
 

These are old radiological units in millirep.
 

For all practical purposes, those can be
 

considered equivalent to millirem for our
 

demonstration.
 

But you can see that there's quite a
 

distribution of – this is the average 24-hour
 

dose rate at each of these locations as measured
 

in May of 1947. I believe it's for the entire
 

month, average. So knowing that the average
 

background radiation in the United States from
 

just standing on a spot of soil somewhere is
 

around ten microrem per hour, that equate, for 24
 

hours, to about .24 millirep for 24 hours.
 

So one can see that for some cases around
 

here, the 100 area, it's fairly close to
 

background. But here it's .7 millirep, so that's
 

quite elevated above background, not quite a
 

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factor of ten — not ten, point — here's a higher
 

one, 2.2 millirep per hour. So there's a
 

distribution, and it's almost — this is almost a
 

factor of ten above what we would consider to be
 

ambient, natural background. So this would —
 

someone obviously working in this area
 

unmonitored has a potential for some
 

environmental exposure, would need to be added
 

back.
 

I don't know and don't expect that the
 

quality of data is going to be this good for
 

sites, but when we do know it we certainly have
 

to consider it and include it in the exposure
 

profile.
 

The medical dose, I'll just touch on briefly
 

again. Required medical X-rays, there are
 

examples in the case files — not case files, but
 

the dosimetry medical files of workers at some
 

facilities, particularly in the early years where
 

stereoscopic X-rays were taken — it's known as
 

photo-fluorography, which is essentially a
 

fluoroscopic examination of the chest with the
 

fluoroscopic image transferred to film. They
 

would take a picture of a fluoroscope,
 

essentially. And I believe that was primarily
 

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because you could do screening a lot quicker, or
 

you could just take these pictures and then go
 

review them.
 

The doses from those procedures, since they
 

were fluoroscopically based, is quite large
 

compared to current day medical X-rays, which are
 

the order of 10, 15 millirem. There has been
 

some research done into this, and especially dose
 

to, for instance, red bone marrow has been
 

determined from a fluoroscopic – or photofluorographic examination to be as high as 800
 

millirem.
 

So again, in some workers' cases, this may
 

be their dominant source of exposure,
 

occupational source of exposures, particularly if
 

this was considered — was required for them to be
 

employed at the site. So that's one of the main
 

reasons we want to add these back in, because
 

there are some out in the files, and we've seen
 

them, some large doses that need to be considered
 

and added back in from this means of exposure.
 

And as the little equation indicates, the
 

occupational medical exposures, just a summation
 

of the number of X-rays times N, although Di may
 

be somewhat difficult to obtain. We are asking
 

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from the Department of Energy to provide us —
 

most medical facilities won't know what the dose
 

was, but if they provide us the manufacturer and
 

the make of the X-ray machine and the kilovolt
 

potential, those type of pieces of information,
 

we should be able to get some sort of an estimate
 

from them. There just weren't all that many
 

types of machines out there.
 

Okay, conversion to organ dose. I talked
 

about yesterday the ICRP 74 methodology. So
 

we're going to either convert from ambient deep
 

dose equivalent or the deep dose equivalent, and
 

these are as defined in the ICRP terminology,
 

H*(10) and Hp(10). It's just — the H is, of
 

course, dose equivalent, and the ten just refers
 

to a ten millimeter depth.
 

As we discussed, the ten millimeter depth is
 

not necessarily adequate to estimate the dose to
 

certain organs that may have been exposed that
 

are deeper in the body. And the factors that
 

will affect this conversion are what the target
 

organ is. An organ such as the thyroid that is
 

very close to the surface is going to be very
 

close to Hp(10), or the breast tissue, especially
 

for high energies.
 

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When you get into organs that are dense and
 

deep within the body such as red bone marrow,
 

which would be the organ we would calculate a
 

dose for leukemia induction, much significant
 

corrections may be required. And also it's
 

energy dependent, so the lower the energy, the
 

greater the effect. And the exposure geometry,
 

whether you are standing in a parallel beam of
 

radiation or moving around in a circle, it makes
 

a difference.
 

I just have a graph here that — it's a sort
 

of busy graph, but it does depict what I'm
 

talking about. And this is a specific example
 

for a bone marrow dose conversion factor as a
 

function of photon energy, and I've got it
 

sketched out for four different exposure
 

geometries.
 

So for example, if you look at the yellow
 

line — not yellow, the dotted line here, the
 

anterior-posterior, that's the AP. The beam is
 

coming from the front, and you're working in a
 

glove box or a fume hood or something like that,
 

and you're wearing the badge right here on your
 

lapel.
 

This is the ICRP 74 predicted conversion
 

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factor that one would use as a function of
 

various photon energies. You can see that it
 

never really approaches unity, so it's always
 

going to be some reduction. And we need to
 

determine at what point we're going to not even
 

bother with the correction. But you can see that
 

if you get below 100 keV there's a dramatic drop-


off here, which you'd expect because lower energy
 

photons have less penetrating power through
 

tissue.
 

So you get down into here, and if you're
 

looking at 60 keV for americium — 20, 30, 40 —
 

it's going to be less than a quarter of the dose
 

that your badge had measured, particularly in the
 

early days when they didn't correct. Essentially
 

what the film badge was reading was roentgen air
 

exposure, which doesn't account for any tissue
 

depth penetration at all.
 

So we need to really be careful down in
 

here. Plutonium X-rays are down in here around
 

17 to 20 keV. In some cases we can say that the
 

badge probably can't even read what the bone
 

marrow — or the bone marrow dose is not even —
 

the badge may over-predict by a factor of 100
 

what the bone marrow dose is.
 

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So we're going to be looking at this and
 

where to apply this correction factor. Right now
 

we've got it to be corrected across the board.
 

But there are some instances where I think,
 

especially in the efficiency approach that we
 

talked about adopting, we may not even bother —
 

like we'll over-estimate everything so we won't
 

make any corrections, and if the claim is below —
 

at a very low POC, we're not going to bother.
 

The good thing is this is all easily
 

computerized. These are standard formulas that
 

we can plug in and run.
 

The geometries that I presented here, the
 

anterior-posterior, rotational and isometric, I
 

don't expect that the posterior-anterior's going
 

to be that common. That would be radiation
 

coming only from your back. I can imagine
 

possibly a medical exposure or geometry where a
 

person's running a fluoroscopic machine with
 

their back to the beam, I'm not sure. But for
 

completeness it's in there. We can certainly
 

deal with it if we have to.
 

And again, these are examples of different
 

types of exposure geometries where – drum storage
 

in a warehouse, certainly a person is being
 

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exposed, most likely in a four pie essentially
 

geometry; glove box or fume hood worker would be
 

AP; and a reactor worker may be some combination
 

of those two.
 

And the final uncertainty distribution is
 

going to be determined — I didn't have time
 

today, and I think at future meetings we can
 

discuss some of the uncertainties about those
 

other geometries. But the final uncertainty will
 

include — I showed you a sample of how that Monte
 

Carlo calculation would go for the dose for the
 

badge result itself, and then we will do a likely
 

— an uncertainty distribution as well for the
 

missed dose, the environmental dose, and the dose
 

conversion factor. And I've indicated here what
 

our best guess is, our best estimate is for the
 

distribution about those four types of components
 

of the dose calculation. Perhaps at a future
 

meeting we can go through those and some of the
 

logic behind the assignment of those various
 

distributions.
 

Let's switch gears a little bit now and get
 

into something a little less analytical and a
 

little more difficult to nail down analytically
 

with one’s computer program, but I'd like to talk
 

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to you about how we're going to deal with the
 

internal dose issues, which more than likely are
 

going to be — it would have the potential to be
 

the largest component of dose in the DOE work
 

force, particularly with the alpha emitters.
 

As I talked about, alpha emitters have a —
 

are of no consequence from an external dosimetry
 

perspective. It's the opposite. In the internal
 

dosimetry world they're everything. An alpha has
 

a quality factor of 20, so just by virtue of that
 

you're — they're five MeV type emission cell,
 

there's a lot of energy deposited, biologically-


damaging energy deposit per unit emission.
 

So again I'll start with a fundamental
 

definition, which is dose received from
 

radionuclides deposited in the body, and we are
 

considering four possible means of entry into the
 

body, as standard in dosimetry. We can either
 

inhale them, we can either ingest them, they can
 

be either injected or absorbed through a puncture
 

wound, or they can be absorbed through the skin,
 

such as gaseous tritium vapor.
 

Radon exposure is evaluated not using a dose
 

model within IREP. We didn't talk about this
 

earlier, but the IREP model itself is purely
 

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based on exposure in working-level months. And
 

the National Cancer Institute has updated IREP to
 

include the radon model that was used
 

essentially, I think, for the — well, I don't
 

want to say something not correct here. A lot of
 

the uranium miner data was used to — the risk
 

values established with the uranium mining was
 

used to establish the working-level model in
 

exposure for radon. So in this case we're not
 

going to dose at all. We're going from exposure
 

using epidemiologic data and going directly to
 

risk. So what I'll be talking about today for
 

internal dose does not apply to radon daughters.
 

Okay. To do the calculation we divide it
 

into steps. One, the key component is to
 

determine the intake, how it's transferred
 

through the body, and then the excretion, because
 

the excretion is pretty much the only handle that
 

we have available to quantify internal dose after
 

the fact. The 66 model is used for inhalation,
 

and we intend to use ICRP 56, 67 and 69 that
 

include these updated specific biokinetic models
 

that I talked about. They're the recycling
 

models that are not single, first-order rate
 

kinetics with no recycling. They account for the
 

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ability of material to be deposited in the organ,
 

go back into the bloodstream, and then be
 

redeposited. These new recycling models do not
 

exist, however, for all nuclides. This is new
 

technology, so where they don't exist we will use
 

the default ICRP 30 metabolic models.
 

From an internal dosimetry perspective, this
 

is what the human body looks like, a bunch of
 

boxes with little arrows. I'm trying to indicate
 

and make a little simpler by the things
 

highlighted in red are modes of entry into the
 

body. So as I discussed earlier, we can have an
 

ingestion, inhalation, or a puncture wound coming
 

into the body.
 

And we can also remove things from the body
 

by various means. We can either have — we can
 

either breathe something in, and some of it
 

doesn't get deposited. As a matter of fact, most
 

of what you breathe in doesn't become deposited.
 

It comes right back out. Or – I like this – this
 

is ICRP 66, has defined extrinsic removal, which
 

is essentially blowing your nose, kind of a fancy
 

way of saying nose-blowing. And of course we can
 

eliminate material metabolically that comes out
 

through the urine or material that passes
 

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directly through the GI tract in the feces. This
 

is an error on my part. I indicated sweat as a
 

mode of input into the body. In fact, it is a
 

removal mechanism. So one can sweat out tritium
 

vapor, for example, tritiated material.
 

Yes.
 

DR. ZIEMER: Quick question. Likewise,
 

aren't there examples where you can ingest — if I
 

can use that word — tritium directly through the
 

skin?
 

DR. NETON: Yeah.
 

DR. ZIEMER: So it could be an input as well.
 

DR. NETON: Right. I didn't mean to imply
 

that that was the only means. It is a means.
 

Tritium can also be ingested, inhaled or
 

absorbed. It's one of the more metabolically
 

easy to model, but difficult to figure out the
 

entry mode.
 

So what we have here is the respiratory
 

tract model, which this would represent the ICRP
 

66 model that really is — I don't know, it's
 

about 20-something compartments. It's an
 

extremely complicated model. I didn't show it
 

for this meeting because I thought maybe we
 

wouldn't have enough time. But when material
 

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goes into the respiratory tract, it can be
 

absorbed into what's called the transfer
 

compartment here, which is essentially the
 

bloodstream. So any material that gets into the
 

bloodstream then can be deposited in any of these
 

various compartments. And that in fact is what
 

we were doing with this IMBA program. We have 36
 

possible organs with which to calculate a dose
 

to.
 

One difficulty we have, though — I talked
 

about this a little bit yesterday — is that the
 

36 organs, unless the organ is metabolically
 

involved in the accumulation of the radionuclide,
 

it's very difficult to calculate a dose to that
 

organ. For example, the prostate gland does not
 

really concentrate plutonium, at least to any
 

extent that the ICRP would recognize.
 

So we are calculating the dose from adjacent
 

organs irradiating the prostate gland that have
 

material, but we are also considering this
 

transfer compartment, since this — radioactive
 

compounds are actually in the bloodstream and
 

circulate through the body, we can actually
 

calculate the dose to this transfer — the number
 

of transformations that occur in the bloodstream.
 

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And if we know the volume of blood that's in any
 

of these other organs, then we can come up with
 

some estimate of the dose.
 

It's going to be small, but for completeness
 

sake, I think we probably ought to add that back.
 

It's intuitive to me that it's going to be small,
 

but I think we really need to document that, or
 

at least document why it's small. So we're going
 

to be adding that analysis in the future.
 

Okay, I've kind of beat this to death. It's
 

the 66 model that was developed in '94. It
 

really corrected some deficiencies. It allows
 

for a much larger particle size range than the
 

ICRP 30 model did. It allows for modeling the
 

deposition and movement of gases in and out of
 

the lung. It allows for much more latitude of
 

applying shape factors to particles. The title
 

volume of the worker can be modeled all the way
 

from resting to active. There are age adjustment
 

coefficients. I'm not sure that we're going to
 

use all those, but the flexibility is built into
 

the model. Thirty was the previous one, and I've
 

already talked about most of that.
 

Okay. There are still two models that we're
 

using, which is the gastrointestinal model, the E
 

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model, which is a fairly old model. It is
 

essentially a three-compartment model with linear
 

first order rate kinetics through it, still works
 

well for our purposes.
 

And the bone model. The bone model allows
 

us to have two source organs, so essentially the
 

bone is considered two organs. There's
 

trabecular bone and cortical bone, and those both
 

metabolically behave very differently. And those
 

two source organs can irradiate two target
 

tissues within the bone, which is red bone marrow
 

and bone surface cells. And that allows us to
 

calculate the dose to the bone surfaces and the
 

dose to the red bone marrow, so therefore we can
 

actually estimate a dose for either osteosarcoma,
 

which would be a dose to the red bone cell
 

surfaces, or leukemia, which would be a dose to
 

the red bone marrow.
 

So it's a useful model. We certainly will
 

be doing a number of those kind of calculations,
 

and I don't see any reason why it needs to be
 

replaced at this point. There really is no
 

better model available, in my mind.
 

The absorption values specific for the GI
 

model have been updated. Even though we're using
 

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the old E model for the gastrointestinal tract,
 

there's some newer information about what was
 

known in the field as the F1 value – that is the
 

amount of material that's absorbed across the
 

gastrointestinal tract as it moves through. For
 

some materials, such as plutonium, it's ten to
 

the minus fifth, a very small fraction, so almost
 

none becomes deposited in the body; whereas if
 

you actually ingest cesium, it's considered to be
 

100 percent absorbed in the gastrointestinal
 

tract. So those factors — we're going to be
 

using the newer factors for those models, even
 

though we're going to be using the old model.
 

The IMBA program, we're somewhat excited
 

about this. This is a new program. It's never
 

been used in the U.S. to my knowledge before. We
 

have the first, I think, working version in the
 

United States. It's a beta version, developed by
 

ACJ & Associates. Some of you may know Tony
 

James, who worked for a number of years out at
 

the Hanford site — worked at Battelle, not the
 

Hanford site, sorry — and in conjunction with the
 

NRPB, the National Radiation Protection Board in
 

England, specifically Alan Birchall, who is a — I
 

guess it's not an exaggeration — a world-renowned
 

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internal dosimetrist in his own way. He's done a
 

lot of the modeling.
 

We've taken advantage of what's been done by
 

the NRPB in the past, and they've essentially
 

modified it for our compensation program's
 

specific needs. And we continue to work with
 

them to refine this model to make it more useful
 

for our needs. Most of those efforts are being
 

put into the area of automation. With these
 

number of claims that we need to process, it is
 

still a fairly manual entry process for us. And
 

when we can get the front end where we can
 

actually import bioassay files one after another,
 

it'll be a nice addition.
 

This is just an example of the IMBA screen,
 

and nothing new here other than just to
 

demonstrate that it does allow for a number of
 

different metrics. One can type in the — a
 

number of different analyses. One can type in
 

different measurement types. We're limited right
 

now in the number of radionuclides, but we've
 

targeted the ones that we feel are going to carry
 

the bulk of the DOE exposures, those being
 

radionuclides such as uranium, americium,
 

plutonium. We do have a few fission products
 

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modeled, but we're working to expand that
 

distribution, the number of radionuclides that
 

we're modeling.
 

One can put in there measurement type, and
 

we can calculate the dose over a specified
 

interval, which is extremely important for us.
 

We can put in the date of initial employment and
 

the date of diagnosis, and it will provide an
 

annual dose, internal dose, for every of those
 

years and fractions of years thereof to the 36
 

individual organs. Because if you remember we
 

were doing multiple cancer — I mean, if there are
 

multiple primaries, we have to do a dose for each
 

primary.
 

And also, if the primary is unspecified, if
 

you remember that table, if you're guessing — not
 

guessing — if it's a secondary cancer you have to
 

estimate what the primary is. In some cases that
 

table in the IREP rule specifies six or seven
 

different organs. That means the dosimetrist
 

will have to calculate and provide the Department
 

of Labor the internal and external dose for six
 

or seven separate organs per case. So it's very
 

important that this prints out — it doesn't just
 

do one organ at a time. It'll do all of them,
 

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and then we can work through that that way.
 

Some important features that we like about
 

this program, of course it does handle acute or
 

chronic exposure situations, and it's fairly
 

flexible. We can modify just about any of the
 

parameters we want to meet our specific needs,
 

and we do expect to encounter a number of
 

different scenarios. And it's also useful for us
 

establishing what I talked about as the missed
 

dose for the monitoring programs. We can put in
 

the detection limits for certain bioassay
 

frequencies and samplings, and run through this
 

multiple times and generate what we ought to call
 

missed dose profiles for a certain site over
 

certain periods of time. So it'll be very useful
 

for us to do that with acute chronic scenarios
 

and different solubility classifications.
 

Right now there's four types of bioassay
 

samples that are supported: That is a whole body
 

count, and partial body measurements as well –
 

whether you measure the lung or the whole body,
 

it can account for that; lung measurement;
 

urinary excretion; and fecal excretion. It
 

doesn't handle right now breathing zone air
 

samplers, which I'd like to add. A breathing
 

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zone air sampler, in my mind, is essentially a
 

device that measures intake, 20 percent of your
 

intake that runs at one liter per minute.
 

And a little bit about the outputs. It
 

gives total intake. We don't really need it for
 

our purposes, but it will provide committed
 

effective dose equivalent. I mentioned the
 

committed dose for each of the 36 organs,
 

effective dose, and the dose to each organ. So
 

it certainly is capable of providing us what we
 

need.
 

DR. ZIEMER: Jim, you indicated this was in
 

the beta testing stage?
 

DR. NETON: Right. That's correct.
 

DR. ZIEMER: And when will it become
 

available, and will it be on-line?
 

DR. NETON: I'll answer the second question
 

first. I'm not sure we're going to be able to
 

put it on-line. We certainly will do that if
 

it's possible, but this — we are in an agreement
 

with ACJ, and somehow with the NRPB as well. I'm
 

not sure — our lawyers need to look into that
 

issue, as to whether we can put it on-line based
 

on our licensing agreement with ACJ.
 

When it'll be available in its full version,
 

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I'm hoping that we have this available within the
 

next few months to have something that we can say
 

is ready to go, although that's not to imply that
 

this is not a working version. It is a
 

functional version. It does work. Most of all
 

of the testing that needs to be done has been
 

done on the modules themselves. There's been a
 

lot of independent review on the individual
 

modules. All that IMBA really does is assemble
 

the I/O, the input/output, and reformat. That's
 

one of the things we liked about it.
 

So I'm hoping in the next few months that we
 

can get the more production version going —
 

certainly before we have to do the — in the April
 

time frame when we have to start running — we can
 

start running them for probability of causation
 

calculations.
 

If we're going to do a dose reconstruction,
 

it is a detective game. It's somewhat different
 

than the external dose world, and here is why.
 

There's a number of reasons the red dots sort of
 

outline.
 

The detection limit for the measurements
 

vary all over the board. It's not as simple as a
 

badge read. The type of radioanalytical
 

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technique used historically varies widely from
 

the early 50's to the 90's. There are now
 

techniques with thermal ionization mass
 

spectrometry that can measure plutonium that is
 

orders of magnitude below anything imaginable
 

even when I was in graduate school, which was
 

probably longer ago than I care to admit. So we
 

need to really find out the facility's specific
 

detection limits, and that's going to require
 

some detective work on our part.
 

We intend to go through and develop facility
 

profiles, and fortunately many facilities have
 

done this. Some of the larger facilities do have
 

historical documents that have been put together
 

that do outline a lot of this information.
 

We need to determine the exposure type. Was
 

it an acute, one-shot deal based on an incident,
 

or was this a chronic type exposure that occurred
 

to the worker? Of course, the exposure mode
 

makes a huge difference, whether it was inhaled,
 

ingested, or whether it was absorbed through a
 

wound.
 

The effect of previous intakes on results.
 

For example, what you're seeing today, is that
 

being influenced by something that was coming out
 

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in the urine before that, and that needs to be
 

considered. And of course, the estimate of the
 

date that the intake occurred. If you have no
 

knowledge of when the intake occurred and you
 

have a positive bioassay result, almost the only
 

recourse you have to do an estimate is to go back
 

to the last time a sample was taken and it wasn't
 

detectable. That can result in some very large
 

missed doses, and so that all needs to be
 

considered as part of this little detective game.
 

And of course, the physical characteristics
 

of the source material. Just because you have a
 

bioassay sample does not mean that it's
 

interpretable because of the solubility of the
 

material. If it's very insoluble uranium and
 

it's in the lungs, a much smaller fraction's
 

coming out in the urine per day than if it's
 

extremely soluble uranium. So we need to develop
 

again these site-specific profiles, so we know in
 

which facility what type of solubility material
 

was being used.
 

I alluded to this a little before, but here
 

are the types of data that we have to determine
 

dose. Particularly in the bioassay world, we
 

have the in vivo results, the urinalysis, fecal
 

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samples and breath samples. And by breath
 

samples, I'm specifically talking about breathing
 

— well, actually there's two — I mean two things
 

by breath samples. There's breathing zone air
 

samples that hang on the person's lapel that are
 

a fairly decent indicator of at least the
 

magnitude of the level of exposure.
 

But breath samples, of course there are some
 

time periods for radium body burden analysis. I
 

know at the Fernald site this was done where
 

people were measuring radon emanating in the
 

breath due to radium 226 imbedded in the
 

skeleton. And there's a similar technique called
 

thoron analysis that's analogous for measuring
 

thorium depositions. There aren't a lot of
 

those, but we certainly will look at those if
 

they're available.
 

So we have these four techniques available
 

to us —
 

DR. ZIEMER: I think we have a question
 

here, perhaps.
 

DR. ANDRADE: Real quick question here. For
 

your purposes and the way you're going to do your
 

analyses, how do you differentiate between acute
 

and chronic for internal —
 

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DR. NETON: Right. It's going to be —
 

DR. ANDRADE: — for intake.
 

DR. NETON: It depends on what's available.
 

If we have a fairly good bioassay program record
 

— for instance, a person had a monthly bioassay
 

sample — one can determine based on the level
 

that's coming out in the urine over time whether
 

or not that person was chronically exposed. If
 

it was an acute exposure, one would see the
 

subsequent samples dropping off rapidly, fitting
 

— the drop-off consistent with the models that
 

you would employ. You do need to know, though,
 

facility-specific information.
 

DR. ANDRADE: Right, but again — and I think
 

you talked about it yesterday a little bit — when
 

you're talking about plutonium internal
 

dosimetry, you're talking about plutonium that's
 

going to be in your body for the rest of your
 

life.
 

DR. NETON: Right.
 

DR. ANDRADE: So therefore, you're going to
 

consider that a chronic exposure, is that
 

correct?
 

DR. NETON: Yes. Yeah, maybe I
 

misunderstood your question, but yeah. Once you
 

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have a plutonium intake, it's going to be a
 

chronic exposure over the time period from the —
 

to the date of diagnosis, for sure.
 

DR. ANDRADE: Right. Now on the other hand,
 

take the case of iodine, biological half-life of
 

a few days. Is that what you consider an acute —
 

DR. NETON: No, that would also be chronic,
 

because as we talked about yesterday, the
 

definition of chronic for these risk models is
 

something that happened over — the definition of
 

acute is something that happened in less than a
 

couple of hours. Chronic is like more than a few
 

hours. And the half-life of iodine in the
 

thyroid, I think, is somewhere around eight days.
 

So that would also be a chronic exposure.
 

DR. ANDRADE: Chronic, okay.
 

DR. ZIEMER: But you distinguish between
 

acute and chronic intakes?
 

DR. NETON: Right.
 

DR. ZIEMER: Which is not the same as dose.
 

DR. NETON: Right. That’s right, yeah.
 

That's what I thought your first question
 

was alluding to, which is an acute intake where
 

in the earlier production mode of operation at
 

uranium facilities, a certain amount of ambient
 

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airborne uranium was acceptable. One could say
 

that as long as I stayed below ten percent of the
 

annual exposure, the limit or the maximum
 

permissible concentration in air, it was okay.
 

So one was breathing about ten percent of the
 

allowable concentration.
 

That would require us to use a different
 

model on that person to determine his intake than
 

if it were an acute exposure. Although one can
 

argue that a chronic intake is nothing more than
 

a series of continuous acute intakes, and it ends
 

up being that way, approximating that way in the
 

models. Either way you take it, it ends up the
 

same way. But the chronic allows you to bypass
 

some calculations.
 

Okay. We do intend to rely on incident
 

reports. These are valuable for pulling up a lot
 

of that detective information that we're talking
 

about. If a person was involved in an incident —
 

that was some off-normal event that happened
 

where he was required, more than likely would
 

have been required to leave a bioassay sample,
 

names of coworkers would have been potentially
 

recorded, what the person was doing at the time —
 

those types of pieces of information would be
 

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extremely helpful in nailing down a specific
 

incident when they do happen. And we're hoping
 

that we can retrieve those things in the person's
 

monitoring files as we request them.
 

Airborne radioactivity concentrations,
 

lacking any other bioassay information, of course
 

are useful to a certain extent to reconstructing
 

exposure. And those can be of several different
 

types, whether it's breathing zone air samplers,
 

general area samplers, or just estimates derived
 

from gross contamination levels in a facility.
 

So I'm going to go through a couple examples
 

of what we would do for bioassay data, how we
 

would look at some airborne air sample data, and
 

how we might approach a estimate just based on
 

some first order — first principle source term
 

analysis.
 

Although before I do that — I jumped a
 

little bit ahead — I need to talk about missed
 

dose a little bit. And we actually talked about
 

this, is the dose that could have been received
 

and been undetected. And it's a function of a
 

number of different things as based on the
 

detection limit of the bioassay sample and the
 

monitoring frequency.
 

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The solubility, as I talked about, is a
 

major factor in this dose. And we've done a
 

number of calculations using our IMBA program and
 

putting in hypothetical exposure scenarios for
 

what we believe to be the detection limits of the
 

monitoring programs at certain sites. And for
 

what's considered pure class S material — that's
 

solubility material that is removed from the lung
 

slowly. There's three classes of solubility: F,
 

M, S – fast, medium and slow. For the ICRP 30
 

types that's equivalent to D, W and Y. For pure
 

class S material, there could be a missed dose to
 

the lungs that results in greater than a 50
 

percent probability of causation without any
 

positive bioassay.
 

This is a serious limitation of bioassay
 

monitoring programs that we pretty much knew
 

going in. So it's possible that a person who
 

breathed in soluble material, who was exposed in
 

a facility with insoluble material, and was
 

monitored even monthly in the urine for urine
 

samples and never showed a positive sample, one
 

could estimate that there was a potential for
 

that person to have had a dose that was greater
 

than 50 percent POC for lung.
 

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And this speaks to the issue of whether one
 

is monitoring an organ — one has a cancer of an
 

organ that is a source organ that deposits the
 

activity, or it's an organ that the activity
 

doesn't concentrate in. So in many facilities
 

solubility of material is really a mixture, and
 

we know that. We've done enough examination that
 

there really is no one type that fits all
 

facilities, and we need to consider that.
 

If you get down to this class M material
 

which is moderate solubility, it's going to be a
 

small contributor to the dose, more than likely,
 

or it is a small contributor. But it can result
 

in very large bioassay results, so — bioassay
 

samples. So really need to consider the
 

solubility of material.
 

Okay, I'm going to go now and talk a little
 

bit about this efficiency approach using bioassay
 

samples, and this is the same example I had
 

yesterday, but I have a little more detail on the
 

screen.
 

If you remember the flow chart we had, we
 

said, okay, let's pick the mode of exposure that
 

the person was most likely exposed. So here we
 

have a person who worked at a plutonium facility
 

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and left bioassay samples between 1961 and '65 —
 

this is real data, it's not made up — and you can
 

see that after about '64 his bioassay samples
 

popped up and was well above the detection limit,
 

as I talked about yesterday, which was about .05
 

picocuries per liter, so it's down in here.
 

So he had some evidence of what I would call
 

chronic exposure in this time frame, but nothing
 

that really strikes you — what strikes out as
 

obvious is this bump here. So if we were to say
 

let us just assume that this intake that occurred
 

here, that the bioassay results that are coming
 

out in this time period were a result of an
 

intake that occurred back here in 1961, we can
 

estimate his dose using that intake scenario.
 

And it will be a wild, a very large overestimate
 

of dose. There's no doubt about it, because
 

we're way above any bioassay sampling in this
 

area.
 

And then we can calculate what his dose
 

would be. There's annual dose, and let's assume
 

that he started working in '61, and his cancer
 

was diagnosed in 1969, so we'll stop the analysis
 

there. And here the dose is to, say, three
 

separate organs that we might be evaluating as
 

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primary cancers. It's very obvious for the lung
 

that there's pretty large doses in this column,
 

and it peaks at about 15 rem in 1962. So what
 

that represents is just a clearance of this
 

material out of the lung over time, based on this
 

ICRP 66 model. But if you look at — 89, I think
 

it was 89 in the first year, so these are very
 

large doses. And I'm fairly confident that when
 

I put this into a probability of causation model
 

I would have some fair confidence that this POC
 

is going to be greater than 50 percent,
 

particularly if the person were a non-smoker.
 

The liver's not as clear-cut, though. It
 

does not contain as much plutonium, obviously,
 

over this time period, but it still has fairly
 

large doses. I would say that's still a fairly
 

large exposure and a pretty high probability of
 

compensation to the — because the plutonium moves
 

out of the lung, and we know metabolically it
 

concentrates in either the liver or the skeleton.
 

Those are the three main deposition sites.
 

On the other hand, if the person presents
 

with urinary bladder cancer, the doses are orders
 

of magnitude lower for even this wild, high,
 

overestimate of his exposure. Ignoring this
 

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material here, but saying that this intake
 

occurred way back in '61, this is well less than
 

a rem exposure over that period, so his
 

probability of compensation's going to be fairly
 

low. There's no real indication here.
 

So again we start with our approach, and we
 

say what did our overestimate look like? And
 

here we have three examples of how we might
 

proceed based on that analyses.
 

So then we said okay, let's do an overestimate; now let's go do the other way and do a
 

conservative — not an underestimate, but just
 

take a conservative approach. Let's take a
 

conservative approach and not include all his
 

dose. So this is a blow-up of that graph, but
 

I'm starting from '64, so this represents just
 

that increased time period where he popped up in
 

1964. So here we're saying I'm not going to
 

count any of these points, and I'm only going to
 

model the dose as if it were — started here in
 

1964. So let's say he was exposed in '64. What
 

is his dose, assuming this scenario? So this
 

would be a low estimate.
 

If we take the low estimate, we still see a
 

fairly large lung dose, which I suspect — and I
 

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don't have the data to establish this yet, but
 

that would result in a fairly significant
 

probability of compensation. Or say it were a
 

liver dose that is not as clear-cut, and the
 

bladder, of course, is still low, and we in fact
 

would not have even evaluated the bladder on the
 

second pass because the high — the whole highest
 

(inaudible) would have not even made it.
 

So this is an example of how we would go
 

about using these bracketing estimates using
 

internal dose models that we've established.
 

Yeah.
 

DR. ANDRADE: On each of those examples for
 

input parameters into ICRP 60 methodology, do you
 

also use Monte Carlo to select — to pick it from
 

a distribution those solubilities or particle
 

sizes?
 

DR. NETON: Not in this particular example,
 

because these are our worst case upper limits.
 

Essentially they would be the Monte Carlo upper
 

end samplings without really going through a
 

Monte Carlo.
 

DR. ANDRADE: Okay. So that would be
 

equivalent to an ICRP 26 study methodology
 

assuming Y class material and one micron type
 

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particle size?
 

DR. NETON: It's analogous to that, but
 

we're using the 66 methodology, which would be an
 

S class solubility and five micron particle size
 

default.
 

DR. ANDRADE: Thanks.
 

DR. NETON: Okay. If we don't have any of
 

this nice bioassay data to hang our hat on, we
 

need to go back and look at the work place data.
 

And this is a simple example of how we might
 

use work place air monitoring data to – this is a
 

simple example of say that we happen to have five
 

air sample results for a particular work scenario
 

and this is this red blob here. Here's an area
 

where a worker, Work Area A, could have worked
 

during his period of employment, and this other
 

blob up here, let's call that Work Area B. And
 

we're fortunate enough to find some facility
 

monitoring records which we do have, at least at
 

one facility, some pretty decent records of this
 

nature.
 

And we have these five air samples that are
 

distributed about the site — air sample one here,
 

air sample two, three, four and five. I suppose
 

I could have done a better job of numbering these
 

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air samples, but nonetheless, we have five
 

samples represented by these little blue dots.
 

And these are the measurements that were received
 

or detected at each of these air sampling
 

locations in what's called like, say, 3 DAC,
 

which would be three times the derived air
 

concentration. Those values would be in
 

microcuries per milliliter or becquerels per
 

cubic meter. It sort of doesn't matter for this
 

conversation, but these are all relative values
 

of some level of the regulatorily allowable
 

exposure air concentrations.
 

So how would we go about, for instance,
 

estimating the intake, which is how much
 

material, radioactive material did this worker
 

breathe in in each of these operations? Well,
 

one option is to take all five of these air
 

samples and average them and apply them to each
 

scenario, but that doesn't necessarily make the
 

most sense. And in fact, if we looked at this —
 

if we took Work Area A, I think that we would
 

select half of the air samplers based on sample
 

one and half based on samples two and four.
 

So here's air sample one for Area A, so
 

we'll take half of the air concentration based on
 

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that, and then we would half based on the average
 

of these two to assign it to this work area. And
 

in fact, we would end up using an average air
 

concentration in that work environment of about
 

one and a half DAC.
 

The other scenario —
 

DR. ZIEMER: Is that weighted also for the
 

size of that area, or is it —
 

DR. NETON: No, it's not. This is a simple
 

example. I'll agree with that, and I'm not sure
 

we can get that refined. But it's a good point.
 

This other sample, though, we have an air
 

sampler here and an air sampler here, and the
 

source of airborne radioactivity up here. So
 

clearly, if this is the source and it's pluming
 

out in this direction with the ventilation
 

direction in this manner, then we'd probably be
 

best off extrapolating backwards and taking some
 

interpolation of three, five — five, three and
 

one, and going back here.
 

So it was two at air sampler five, it was
 

four at air sampler three. And if we want to
 

predict back here at the source, I think we would
 

say — we extrapolate one, three and five back, we
 

would predict that the results would be five DAC
 

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based on that location. So — one, three and
 

five, I'm sorry. So we go back this direction
 

and extrapolate, interpolate backwards. So I
 

don't know that we're going to have all this
 

level of detail, but I know at least we are going
 

to have some situations where we're going to have
 

to do this.
 

And of course we need to do something with
 

that result. We just can't report the worker's
 

dose in air concentration. So we're going to
 

convert the intake into — or convert that
 

measurement into some intake using this formula
 

that you see on the screen, which is the
 

concentration times the breathing rate in
 

milliliters per hour — that represents 20 liters
 

per minute breathing standard of reference worker
 

times the stay time – and apply any protection
 

factors as necessary.
 

Now I should say a word about use of
 

protection factors. It is our intent to be
 

somewhat skeptical of respiratory protection
 

factors. Historically they may have not either
 

been worn as instructed, or the fit-testing
 

program may have been adequate to qualify them as
 

protection devices for the workers.
 

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I think in more current environments we may
 

be able to use that, and in fact we are going to
 

be required to use that in situations where air
 

sample results for breathing zone air samplers
 

are taken here, are reported already corrected
 

for respiratory protection factors. I know
 

that's a routine practice at facilities, to take
 

the BZ result and divide it by a factor of 50 if
 

a person's wearing a full-face air purifying
 

respirator, and record that as his intake.
 

So that's going to be in there. We need to
 

be aware of that, and then we need to evaluate at
 

that time whether or not that was appropriate.
 

So we just need to approach this with some
 

trepidation.
 

Okay. And the last of my examples is where
 

we have nothing as far as air concentrations, no
 

bioassay data. And this is a somewhat simplistic
 

example, but it serves to point out that there
 

are something we can do, given that if we know
 

how much material the worker was — what he was
 

working with and how much.
 

And let's take this example where there were
 

no air samplers in the area, and a person was
 

working in a hood and playing — working with
 

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these uranium dioxide sintered pellets, and it
 

was a grinding operation where he's taking
 

certain amount of surface area off of the pellet,
 

and they're a half-inch diameter by a half-inch
 

high.
 

By the way, this is sort of an adaptation of
 

the approach that's used in — those of you
 

familiar with the new Reg 1400 document that
 

talks about the need for air sampling in the work
 

environment, we’re kind of taking a backwards
 

approach and said if there's a need, let's
 

predict what — you have to predict what the
 

potential air concentrations are to determine if
 

you have a need for air sampling. So we've kind
 

of worked this process backwards to come up with
 

these type of examples.
 

Let's assume the fume hood has a face
 

velocity of about 150 linear feet per minute, and
 

the person's working with these pellets a couple
 

of feet from his face with a high-speed grinder,
 

and the velocity of these pellet — the grinding
 

material is faster than the hood can remove it
 

from his breathing zone, and the guy's average
 

rate is about 20 pellets an hour.
 

So he's grinding these pellets. He's doing
 

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about 20 an hour, and there's some potential for
 

airborne generated in his work environment. So
 

again we've assumed that he's removing a 1000th
 

of an inch, and we know the density of the
 

material since it's uranium, and we can calculate
 

from that how much radioactivity is being
 

generated into this airborne sphere of two feet
 

diameter that's in his breathing zone
 

environment.
 

And the predicted — based on that
 

calculation, we can predict that the air
 

concentration — conservatively, because we're
 

assuming it's all ejected towards him — is 1.5
 

times 10-7 microcuries per milliliter. At 20
 

pellets per an hour, we come up with 5 times 10-8
 

microcuries per milliliter. And if one compares
 

that to current — the derived air concentration
 

for insoluble uranium, which this is, it's three
 

orders of magnitude higher than what the
 

allowable limit is.
 

DR. ZIEMER: You didn't say anything,
 

however, about the particle size there. The fact
 

that it isn't captured in the air flow implies a
 

fairly heavy particle. What about the — sort of
 

the mass median aerodynamic diameter —
 

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DR. NETON: That's correct. It would be
 

conservative for us to assume that this was a
 

five micron particle. It's probably more dense
 

than that. By definition, if it's five micron
 

diameter, the density would automatically make it
 

heavier than that, you're right. So this is a
 

bracketing estimate to try to determine if there
 

is a large potential for exposure in this case.
 

So since he's three orders of magnitude above the
 

limit, we could readjust the particle size and do
 

a little more careful analysis, that's right.
 

One nice thing about the IREP program,
 

though, is we are not constrained to point
 

estimates. In fact, one of the allowable inputs
 

is a uniform distribution, meaning I don't really
 

know what this is, but I know it's between A and
 

B. And when you sample the person's exposure,
 

sample all those possibilities uniformly, which
 

would be the most generous distribution one could
 

assign. I'm not suggesting we intend to do that
 

in all cases, but one could.
 

In a case like this — for example, if this
 

worst case analysis came out very low, and we
 

said it's very low, we're not really confident.
 

We know we're within an order of magnitude, and
 

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we know it's from – pick two numbers — one and
 

ten. If that were used as the IREP input and the
 

value were still extremely low, then again we've
 

managed to make a determination regarding
 

compensability one way or the other without
 

really biasing the analysis.
 

DR. ROESSLER: I have a question about the
 

word “we.” This is — the word “we.” This has
 

kind of concerned me all the way throughout your
 

presentation, which again I don't think there's
 

any question about the science. What I'm trying
 

to determine is when you say – all these things,
 

especially with the internal, are going to be
 

done, I assume, on a very individual basis. A
 

lot of this, as you said, is art. It's
 

interpreting, making best decisions.
 

I'm concerned about objectivity. I don't
 

have any question about NIOSH, but I don't know
 

much about the contractor proposals and who is
 

going to be doing this, and who's going to be
 

doing what. And maybe that's too big a question
 

at this point, but that's it, is —
 

DR. ZIEMER: Maybe a preliminary answer
 

would be appropriate, and also some indication of
 

the degree to which you will be able to formalize
 

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the methodologies that are used.
 

DR. NETON: Right. That was going to be in
 

part of my response, and maybe Larry can kick in
 

here at the end with some other discussion. But
 

“we,” meaning NIOSH, intend to document as much
 

as possible how this process runs and provide
 

this to the contractor. That would be through
 

technical guidelines, and actually procedures as
 

to how one flows through these analyses.
 

That being said, though, you are right.
 

Internal dosimetry, we have to rely — allow for
 

some latitude in interpretation. But where
 

information is lacking and cannot be ascertained
 

definitively, one should — one is almost required
 

to default to some conservative assumption
 

without any other information available.
 

We also intend to have a fair level of
 

quality control involved over the contractor,
 

where a certain percentages of the dose
 

reconstructions that are performed will be done
 

separately by us and compared to what the
 

contractor does come up with. We intend to
 

review all dose reconstructions that come out of
 

there — not necessarily review all calculations,
 

but at least they will be issued under NIOSH
 

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letterhead and have at least gone over some level
 

of review by a NIOSH representative.
 

I’m not sure I —
 

DR. ZIEMER: And likewise, is this not the
 

sort of thing that you want this Board to take a
 

look at, some of these actual reconstructions.
 

DR. NETON: Yeah. Oh, yeah.
 

MR. ELLIOTT: That was going to be my —
 

DR. NETON: And the Board, as well, I
 

forgot.
 

MR. ELLIOTT: That was going to be my
 

comment. It's NIOSH — when he's talking “we,” he
 

means NIOSH. It's our responsibility to provide
 

oversight to the contractor who will be doing
 

these dose reconstructions.
 

But I hope through these examples that he's
 

shared with you this afternoon that you start to
 

get a sense of how you might develop your
 

sampling strategy in review of dose
 

reconstructions, because we certainly have
 

started thinking about that when we apply that,
 

not only for the Board but for our own quality
 

control interests that Jim mentioned – which ones
 

we're going to target, which we're going to spend
 

more time on, which we're going to spend less
 

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time on. And he's right, we are going to look at
 

every one they do, and we will spend more time on
 

perhaps something like this until we're confident
 

that we've got it down right.
 

DR. MELIUS: I have a related question.
 

This probably jumps a little bit, but relates
 

back to the proposed regulation also. And that's
 

the issue of how is this going to be documented
 

and then communicated back to the people
 

involved.
 

You talk about what some of the steps are
 

involved, but it really is not clear to me from
 

the regulation, what I've seen so far, is what
 

will be the documentation that will be
 

communicated back to the worker or the claimant
 

that would have a concern, as there's an appeal
 

issue and so forth as the information goes
 

forward. You have put in place a mechanism where
 

the, quote, draft results would be shared and
 

discussed, but it's not clear the documentation
 

for that. And I'm particularly concerned in the
 

case where there is incomplete data. In fact,
 

the data can be so incomplete that you cannot —
 

MR. ELLIOTT: (Inaudible).
 

DR. MELIUS: So what will be the
 

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communication in that case? And I think that
 

also goes to this whole issue of how we do
 

oversight on the process, and also deals with
 

some of these — the appearance of conflict of
 

interest issues in terms of people, potentially
 

some of the people involved or whatever.
 

MR. ELLIOTT: Sure. Well, we certainly
 

can't provide you an example of the communication
 

today, but in a general sense I think these are
 

going to be individualized.
 

And we are going to work with the claimant
 

throughout this whole dose reconstruction
 

process, from not only the point of the
 

interview, but once we approach the claimant with
 

what we consider to be a completed dose
 

reconstruction, we'll consider how we articulate
 

what was done in that dose reconstruction, what
 

the limitations of it were, what issues we want
 

them to be aware of associated with that.
 

So each one of these reports that goes back
 

to the claimant as a draft, before they sign off
 

and accept the dose reconstruction, is going to
 

require a considerable amount of effort on our
 

part to really communicate how we treated their
 

data, if there was data. If there wasn't data,
 

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what did we do to come up with these numbers.
 

DR. MELIUS: I think that maybe there's two
 

separate issues. How do you document it?
 

Because from the point of view doing oversight or
 

sampling the documentation’s important, and the
 

second issue is what part of that or does all
 

that documentation go back to the claimant? And
 

it's — I don't think that's clear from your
 

regulation.
 

MR. ELLIOTT: It's probably not clear. But
 

the claimant will of course have a right to view
 

their whole case file, which we will have added
 

to along this trail of dose reconstruction, and
 

we will walk them through that not only in the
 

report, but actually as we talk to them over the
 

interview and as we develop the dose
 

reconstruction.
 

But this is a good point you're raising, and
 

this is something we probably have not clearly
 

articulated, as you say, in the rule, and we need
 

to pay more attention to that; and when we
 

promulgate the final version, we should address
 

it.
 

DR. NETON: I think, if I could add a little
 

bit to that, I think it's the intent that the
 

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claimant actually receive a copy of the technical
 

report, but on top of that technical report is
 

going to be a one- or two-page summary that is a
 

narrative of what was done in somewhat simpler
 

language, so that a non-technical person could
 

understand it. I do believe they have a right to
 

the technical report that we use to determine
 

their dose.
 

So two pieces of information actually will
 

go to the claimant: A summary report, and then
 

the actual dose reconstruction — not necessarily
 

all the raw data that we've used, but which data
 

that we ended up — we did end up using in the
 

dose reconstruction. He's certainly also going
 

to have a copy of his interview that we conducted
 

with him, because he is required to review that
 

and weigh in on that after we do the interview.
 

And he'll be able to see clearly to the extent
 

that we used the information that he provided
 

versus the information that was provided to us by
 

Department of Energy and monitoring programs, and
 

why it was or was not used in his dose
 

reconstruction.
 

DR. MELIUS: Is the claimant going to be
 

made aware of the information that was not
 

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available? For example, records were missing or
 

unable to find that —
 

MR. ELLIOTT: Yes.
 

DR. NETON: Yeah, that'll be part of a
 

narrative discussion, as to how the — what
 

approach was taken.
 

Grady has a comment.
 

MR. CALHOUN: This is Grady Calhoun.
 

I just, in listening to some of this, in
 

82.26 it's somewhat detailed as to the type of
 

information that would be included in that report
 

and given to the claimant. And some of the very
 

things you're talking about are listed in there
 

as specific items that need to go in there. For
 

example, if data information is given and we, for
 

some reason, decide not to use that, we have to
 

state in there we received it, we didn't use it,
 

and here's why. So I just didn't know if you had
 

read that section or not.
 

DR. MELIUS: Well, no, my question was to
 

the — there was reference as to the documentation
 

of some of the information, but not how it would
 

be communicated to what extent would be
 

available.
 

And secondly, in the — and maybe I’ve missed
 

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it — but in the issue where you're unable to have
 

adequate data in order to do a dose
 

reconstruction, it's not clear how that will be —
 

how your effort will be communicated back. What
 

will the documentation be that will say, sorry,
 

we couldn't do it, or we couldn't find it, or
 

this is what records from those years were
 

missing, or we have — it's a subcontractor, DOE
 

had no records of or the facility had no records
 

of your ever working there, things like that.
 

There's lot of possibilities there that I
 

think are going to be important not only for the
 

claimant, I think they're also to some extent
 

important to the committee in terms of us
 

figuring out — making recommendations for how
 

this program should go and be improved.
 

DR. ZIEMER: Certainly under 82.26, which is
 

really the guideline or will become the rule in
 

some form, there will have to be some sort of
 

SOP, standard operating procedures, as to how
 

they're actually going to carry out the details.
 

I wouldn't expect all the detail to be in the
 

rule itself.
 

MR. ELLIOTT: No. But your point is well
 

taken, Dr. Melius, on if we cannot do a dose
 

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reconstruction, what happens? How do we
 

communicate that, and what happens next to that
 

individual claimant? And this proposed rule is
 

fairly silent on that, and the reason why is
 

you're going to see that come forward in this
 

Special Exposure Cohort petitioning guidelines,
 

in what we're suggesting there. You don't have
 

that in front of you, I know, but —
 

DR. NETON: But we do — there is an
 

inclusion in 82, though, that addresses if we
 

cannot do a dose reconstruction, we can inform
 

the claimant that it was not possible. And what
 

you're saying is we need to detail why. That's
 

not explained.
 

MR. KATZ: Can I interject, just because it
 

— in fact, if you look in that section in the
 

rule, it does explain exactly that we would be
 

explaining to the claimant what information was
 

necessary to do dose reconstruction and wasn't
 

available. So it would be.
 

DR. MELIUS: But explanation, which as I
 

read it was just part of the interview, is a
 

little different than a document that —
 

MR. KATZ: No, this is the report at the
 

end, not the interview. I'm talking about in the
 

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report. It would be a documented explanation,
 

with the documentation of what data was required
 

to be able to complete a dose reconstruction and
 

wasn't available — isn't available. Is that — it
 

would explain how that information would be used,
 

as well as what the information is that's
 

missing.
 

DR. ZIEMER: Well, certainly the issue is
 

noted. It needs — attention needs to be given to
 

that as we proceed. I think it's an excellent
 

point.
 

DR. NETON: I don't want to belabor the
 

point, but there's another side issue to this,
 

and it points to the fact that this report has to
 

be fairly well crafted.
 

As we talk about doing these efficient —
 

applying the efficiency process to claims, it
 

works fine if a person presents with one cancer
 

and that's the end of their story. But a
 

claimant needs to be informed that if they
 

present with a second primary cancer five years
 

down the line, the dose reconstruction that was
 

performed and provided to him is not necessarily
 

the bottom line. If we run through and do this
 

efficiently and say yes for lung cancer, we're
 

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done, we have to go back again and re-evaluate
 

how refined that lung cancer estimate, dose
 

estimate was, because it may not be obvious that
 

the person is qualified or not qualified for
 

compensation.
 

Do you follow my logic on that?
 

DR. ZIEMER: So maybe rather than fairly
 

well crafted, the report has to be very well
 

crafted.
 

DR. NETON: Very well crafted, okay.
 

DR. ZIEMER: Right.
 

DR. NETON: Exactly. These types of issues
 

need to be pointed out in this correspondence and
 

report as early as possible, so that there's no
 

mistake as to what happens down the line.
 

DR. ZIEMER: Jim, this has been a very
 

informative presentation. We thank you. I —
 

DR. NETON: No, I have one last slide to go
 

over.
 

DR. ZIEMER: Oh, I'm trying to turn you off
 

here, but finish up, please.
 

DR. NETON: Okay, sorry.
 

This is just the last slide that talks about
 

how we're going to handle the relationship
 

between primary cancer and organ doses, and we've
 

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envisioned four different scenarios.
 

As indicated in the IREP program, we're
 

going to use ICD-9 codes to determine the primary
 

organ that we need to do the dose for, but
 

there's not always a one-to-one correspondence
 

between the ICRP 30 — the ICRP available organ
 

and the ICD-9 codes. In fact, there are many
 

more ICD-9 organs than there are cancers or doses
 

that we can calculate it for.
 

So what we intend to do is apply this
 

strategy where if there's more than one ICD-9
 

code for a region, we will calculate the dose to
 

the ICRP region that's described and assign a
 

dose. So for instance, in the nasal/pharyngeal
 

area we sometimes have more organs available to
 

calculate a dose than the ICD-9 code applies. Is
 

that right? Hang on. There's more than one ICD9 code for the ICRP region, yeah. So if there's
 

multiple codes, we'll just take that region and
 

apply it across the board. That's an easy one.
 

One ICD-9 code describes organs associated
 

with more than one region, that would be an
 

example of, say, the gastrointestinal tract. If
 

someone has intestinal cancer, we can calculate
 

the dose to the small intestine, the large
 

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intestine, colon. We would calculate the dose to
 

all three, and then take the largest one and
 

default on a conservative side for that estimate.
 

If the organ is not contained in an ICRP
 

dose model, then we would take the dose from the
 

highest exposed organ that's not associated with
 

a known metabolic site. For example, for
 

plutonium, if it — the liver, the lung and the
 

skeleton are the organs that concentrate
 

plutonium. Then we would take the organ just —
 

the next highest organ that is not one of the
 

three sites that's described in the metabolic
 

model and use that. And that would imply that
 

it's an overestimate of the dose because it's —
 

of the 36 organs that ICRP has modeled, they're
 

presumed to be the 36 highest exposed organs
 

internally.
 

And when it comes to lymph cancer it's a
 

little less clear-cut, but we only have a lymph
 

node cancer model in the ICRP models. So if it's
 

clearly a lymph cancer that's associated with the
 

lung region we'd use the lymph model, but outside
 

of that we would use the approach that we just
 

described above for number three, and use that in
 

the remainder organs, take the next highest
 

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exposed organ and assign it.
 

It's claimant-friendly, but as you see from
 

my earlier examples, organs that are not
 

metabolically involved in the metabolism of the
 

radionuclide are orders of magnitude below in
 

exposure levels. So more than likely those
 

organs will not be compensable cancers in those
 

scenarios, but it is claimant-friendly. We'll
 

pick the highest dose.
 

Okay, with that, I will conclude my
 

formal remarks.
 

DR. ZIEMER: Well, the comments I made
 

before your last slide still hold. We do thank
 

you for that.
 

Let me ask if any of the committee members
 

have additional questions before you're seated
 

here.
 

[No responses]
 

DR. ZIEMER: Okay, thank you, Jim.
 

MR. ELLIOTT: If I could ask —
 

DR. ZIEMER: Oh, yes.
 

MR. ELLIOTT: I want you to be aware that
 

we've kind of been feeding you information here,
 

information yesterday about this dose
 

reconstruction rule, a little more information
 

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today about the technical aspects of internal
 

versus external dose reconstruction. And in the
 

next meeting in February it's our intent to
 

present to you, in advance of that meeting so
 

that you have time to review them, the technical
 

guidelines for both internal and external dose,
 

okay? So I just wanted to give you a sense of
 

how I see this as progressively tasking the
 

Board. So you're going to get more detail next
 

month on this.
 

DR. ZIEMER: Jim, comment?
 

DR. MELIUS: Can I ask just in terms of the
 

process here of obtaining the information, is
 

there a formal agreement between NIOSH and DOE in
 

terms of getting — making available the different
 

types of information that will be necessary for
 

this process?
 

MR. ELLIOTT: We are working on that. We
 

have a draft Memorandum of Understanding in our
 

department going through review. The Department
 

of Energy is waiting for that to be sent over for
 

their examination, and that's our intent. Much
 

of this MOU does address the need and issues
 

surrounding provision of data and information.
 

DR. MELIUS: Because I thought NIOSH had,
 

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with the regulation, done a good job of outlining
 

the various sources of information and might be
 

used, but those are also going to have to be made
 

available in order to use it. And it's not an
 

inconsiderable burden to obtain this with a lot
 

of difficulty, even in the best of circumstances.
 

DR. ZIEMER: Now I call attention to the
 

agenda. We're overdue for a break, but I notice
 

if we take the break then we are rapidly at our
 

closing time.
 

I'd like to ask the committee — well, my
 

feeling at this point is that we probably are not
 

at a point where we want to or will be able to
 

spend any extended time on looking through the
 

rule itself this afternoon. We at best would
 

have about 15 minutes and barely get into it.
 

On the other hand, my plane leaves very late
 

today, so I can stay if there's just a great
 

urgency or urge on the part of the committee
 

members just to stay on for two, three more
 

hours, why we can do that. But we actually have
 

put in a lot of time today. I think it's been
 

productive. And if there's no objection, we will
 

continue the working session on dose
 

reconstruction at the next meeting, where we will
 

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get into the rule itself in more detail.
 

I do want to —
 

DR. MELIUS: Just one question, not saying
 

this will be necessary, but I assume that Larry's
 

offer to reopen the rule for comment still holds,
 

the dose reconstruction portion of the rule?
 

MR. ELLIOTT: We're going to check on
 

whether or not we actually have to do that to
 

effect a reopening of the comment — the record to
 

incorporate your comments, or if we can just add
 

them to the record at the point in time they're
 

available.
 

DR. MELIUS: Okay. That would actually be
 

helpful, I think, for some of our future issues
 

between now and — particularly between now and
 

when the whole process becomes operational, when
 

the rule becomes final. I think it'd be easier —
 

DR. ZIEMER: Thank you.
 

DR. MELIUS: — if we didn’t have to do that,
 

because I do think — the sneak preview of the
 

Special Exposure Cohort process, I think, may
 

affect how we want to say — it actually may
 

affect how the rule would work, too, I think.
 

DR. ZIEMER: I'd like to remind the members
 

of the Board to provide to Larry Elliott the
 

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information on their preparation times.
 

MR. ELLIOTT: And your calendar for —
 

DR. ZIEMER: And your calendar, if you
 

haven't already done that.
 

MR. ELLIOTT: I need to know — just write
 

down on that little pad there, Jim, one page, how
 

many hours or how many days you spent —
 

DR. ZIEMER: Your name and the hours of
 

preparation time.
 

MR. ELLIOTT: — preparing. And don’t be
 

embarrassed —
 

DR. ZIEMER: I also would like to give
 

members of the public, if there's anyone else
 

here that did not have an opportunity to make
 

public comment but wishes to do so, we can
 

accommodate that at this point.
 

[No responses]
 

DR. ZIEMER: They're as anxious to leave as
 

everybody else.
 

We do appreciate the input we've gotten from
 

members of the public. Appreciate the good work
 

of the NIOSH staff and others who have
 

participated and supported the work of the Board,
 

and certainly appreciate the effort of the Board.
 

I think we made good progress in the last two
 

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days, and we're off to a good start, and we
 

commend you on that effort.
 

I'd like to ask if anyone else has any
 

comments for the good of the order before we
 

adjourn?
 

Okay, a comment from Larry.
 

MR. ELLIOTT: Unless you have one —
 

DR. MELIUS: Well, probably the same
 

comment. Certainly thank our Chairman in doing
 

an excellent job in —
 

[Applause]
 

DR. MELIUS: — doing this process and
 

guiding us through the first meeting.
 

DR. ZIEMER: Thank you.
 

DR. MELIUS: You have to abstain from the
 

vote, but —
 

MR. ELLIOTT: That was a little bit of my
 

thunder. I was going to extend my appreciation
 

to Dr. Ziemer, as well as to the Board members.
 

I appreciate your time and your effort and the
 

difficulty it was in getting you all here, and
 

glad that we've had these two days together. I
 

think it's been very productive, and it's been
 

that because of the staff preparation time as
 

well as your own preparation time. So I do
 

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appreciate that. Thank you very much.
 

DR. ZIEMER: Thank you, and we then declare
 

the meeting adjourned.
 

[Whereupon, the meeting was
 

adjourned at approximately
 

3:44 p.m.]
 

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__________________________ 

270 

C E R T I F I C A T E
 

STATE OF GEORGIA )


)


COUNTY OF DEKALB )
 

I, KIM S. NEWSOM, being a Certified Court
 

Reporter in and for the State of Georgia, do hereby
 

certify that the foregoing transcript, consisting of
 

128 pages, was reduced to typewriting by me
 

personally or under my direct supervision, and is a
 

true, complete, and correct transcript of the
 

aforesaid proceedings reported by me.
 

I further certify that I am not related to,
 

employed by, counsel to, or attorney for any parties,
 

attorneys, or counsel involved herein; nor am I
 

financially interested in this matter.
 

WITNESS MY HAND AND OFFICIAL SEAL this _____ day
 

of February, 2002.
 

_


KIM S. NEWSOM, CCR-CVR


CCR No. B-1642
 

[SEAL]