THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

PUBLIC HEALTH SERVICE
 

CENTERS FOR DISEASE CONTROL AND PREVENTION
 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
 

convenes the
 

ADVISORY BOARD ON
 

RADIATION AND WORKER HEALTH
 

VOLUME I
 

The verbatim transcript of the Meeting of the
 

Advisory Board on Radiation and Worker Health held
 

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

on Tuesday, January 22, 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 I
 

January 22, 2002
 

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

WELCOME AND INTRODUCTIONS
 

Dr. Paul Ziemer ................... 4
 

Board Member Introductions .............. 8
 

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

Audience Introductions ............ 11, 51, 92
 

FACA ORIENTATION
 

Ms. Helen Kuykendall ................. 16
 

FILM ON COMMITTEE MEMBERSHIP .............. 25
 

DEPARTMENT/AGENCY WELCOME AND PERSPECTIVES


Mr. Claude Allen ................... 27
 

Dr. Kathleen Rest .................. 31
 

Mr. Shelby Hallmark ................. 36
 

OFFICE OF GENERAL COUNSEL BRIEFING
 

Ms. Mary Armstrong .................. 53
 

REVIEW OF EEOICPA, EXECUTIVE ORDER AND CHARTER


Mr. Larry Elliott .................. 60
 

BOARD RESPONSIBILITIES/OPERATING PROCEDURES


Dr. Paul Ziemer ................. 80, 95
 

PROBABILITY OF CAUSATION RULE 42 CFR PART 81
 

General Background


Mr. Ted Katz ................... 111
 

Scientific and Technical Basis
 

Dr. Mary Schubauer-Berigan ............ 123
 

INTERACTIVE RADIOEPIDEMIOLOGIC PROGRAM (IREP)


Mr. Russ Henshaw .................. 150
 

Dr. Mary Schubauer-Berigan ............. 175
 
3 

 

 

C O N T E N T S
 

(Continued)
 

DOSE RECONSTRUCTION RULE 42 CFR PART 82
 

General Background


Mr. Ted Katz ................... 185
 

Technical Approach - Overview


Dr. James Neton ................. 193
 

PUBLIC COMMENT PERIOD
 

Mr. Richard Miller ................. 222
 

Mr. David Richardson ................ 231
 

Mr. Roger Shaw ................... 240
 

ADJOURN ....................... 243
 

CERTIFICATE OF REPORTER ................ 244
 

Legend of the Transcript:
 

(phonetic) = Exact spelling unknown


— = Break in speech continuity


(sic) = Exactly as spoken
 
4 

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
 
5 

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


Occupational Health Nurse Specialist


Oak Ridge Associated Universities


Occupational Health


Oak Ridge, Tennessee
 

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


Director
 

New York State Laborors’ Health and Safety Trust Fund


Albany, New York
 

WANDA I. MUNN
 

Senior Nuclear Engineer (Retired)


Richland, Washington
 

ROBERT W. PRESLEY
 

Special Projects Engineer


BWXT Y-12 National Security Complex


Clinton, Tennessee
 

GENEVIEVE S. ROESSLER, Ph.D.


Professor Emeritus
 

University of Florida


Elysian, Minnesota
 

INVITED SPEAKERS
 

CLAUDE ALLEN
 

Deputy Secretary


U.S. Department of Health and Human Services 


MARY ARMSTRONG
 

Office of the General Counsel
 

Centers for Disease Control and Prevention
 

SHELBY HALLMARK
 

Director, Office of Workers Compensation Programs


U.S. Department of Labor 


RUSS HENSHAW, M.S.


Office of Compensation Analysis and Support


National Institute of Occupational Safety and Health
 

TED KATZ, M.P.A.


National Institute of Occupational Safety and Health
 
6 

HELEN KUYKENDALL
 

Committee Management Office


Centers for Disease Control and Prevention
 

JAMES NETON, Ph.D., CHP


Office of Compensation Analysis and Support


National Institute of Occupational Safety and Health
 

KATHLEEN REST
 

Acting Director


National Institute of Occupational Safety and Health
 

MARY SCHUBAUER-BERIGAN, Ph.D.


Health-Related Energy Research Branch


National Institute of Occupational Safety and Health
 

STAFF/VENDORS
 

CORRINE HOMER, NIOSH


MARIE MURRAY, Writer/Editor


KIM NEWSOM, Certified Court Reporter
 

AUDIENCE PARTICIPANTS 

JORDAN BARAVY FAY MARTIN 

DAN BURNFIELD JOHN MAURO 

GRADY CALHOUN DAVID MICHAELS 

ALLISON DAVIS FRANK MORALES 

FRANCES DE PEYSTER JEFFREY l. NESVET 

JAMES ELLENBERGER DAVID RICHARDSON 

JOSEPH FITZGERALD D.M. SCHAEFFER 

MIKE GIBSON ROGER SHAW 

MARK GRIFFON JOSH SILVERMAN 

JEFF HILL ROBERT SPENGLER 

LIZ HOMOKI-TITUS DAVE SUNDIN 

ALICE KELLEY ROBERT G. TABOR 

JEFFREY L. KOTSCH ROSE TOUFEXIS 

CHARLES LAND PETER M. TURCIC 

SONYA LEVINE DAVID F. UTTERBACK 

JAMES L. LIVERMAN TRUDI ZIMMERMAN 
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P R O C E E D I N G S
 

48:32 a.m.
 

DR. ZIEMER: Good morning, ladies and
 

gentlemen. We’re going to call the meeting to
 

order, so I would ask that you grab your coffee
 

and juice and so on and please take your seats as
 

soon as possible.
 

Welcome, everyone, to the first meeting of
 

the Advisory Board on Radiation and Worker
 

Health. I’m Paul Ziemer of Lafayette, Indiana.
 

I’ve been asked to chair this board. This, of
 

course, is our first meeting, and we’re all in a
 

way sort of excited about the fact that this
 

effort is now underway.
 

The operations of this Board are governed by
 

the provisions of Public Law 92-463, which is the
 

law that sets forth the standards for advisory
 

committees. This particular Board is charged by
 

its charter and under the Public Law that sets it
 

forth is charged with very specific
 

responsibilities in terms of the matters for
 

advising the Secretary of Health and Human
 

Services with respect to the public law that
 

we’re involved with. And it’s my intent as
 

Chair, and I know it’s the intent of all the
 

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Board members, that we carry out our
 

responsibilities to the best of our abilities.
 

We seek to meet both the spirit and the letter of
 

the law; that’s Public Law 106-398, which is the
 

Energy Employees Occupational Illness Program Act
 

of 2000.
 

Let us begin this morning by introducing the
 

members of the Advisory Board. And they are
 

sitting here at the U-shaped conference table,
 

and we’ll simply go around, and I’m just going to
 

ask for the Board members to introduce themselves
 

and their location or employer. We’ll begin with
 

Roy DeHart right here, and then proceed around.
 

Just the Committee members, and then we’ll
 

introduce the other staff in a moment.
 

DR. DeHART: Roy DeHart. I’m Director of
 

the Center for Occupational and Environmental
 

Medicine, Vanderbilt University, Nashville,
 

Tennessee.
 

MS. MUNN: Wanda Munn. I’m retired from
 

Westinghouse Hanford Company, Fast Flux Test
 

Facility, in Richland, Washington.
 

DR. ZIEMER: I’m not sure everyone can hear,
 

and Wanda, if you wouldn’t mind using the mike
 

and repeating. You don’t have to talk loud, but
 

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just toward the mike.
 

MS. MUNN: Wanda Munn, retired Nuclear
 

Engineer from Westinghouse Hanford Company, Fast
 

Flux Test Facility.
 

DR. ZIEMER: Thank you.
 

Tony.
 

DR. ANDRADE: I’m Tony Andrade. I’m the
 

Group Leader of the Radiation Protection Services
 

Group at the Los Alamos National Laboratory. I’m
 

also a Nuclear Engineer by training, but now a
 

Health Physicist.
 

MR. PRESLEY: I’m Robert Presley. I’m an
 

engineer at the Y12 plant, which is now the BWXT
 

Y-12 Plant in Oak Ridge.
 

DR. ROESSLER: I’m Genevieve Roessler. I’m
 

retired from the Nuclear Engineering Department,
 

University of Florida, and I’m a Health
 

Physicist.
 

DR. ZIEMER: Let me skip over Mr. Elliott a
 

minute and go over to Dr. Anderson.
 

DR. ANDERSON: I’m Henry Anderson. I’m
 

Chief Medical Officer with the Wisconsin Division
 

of Public Health.
 

MS. GADOLA: Sally Gadola, Occupational
 

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Health Nurse Specialist at Oak Ridge Associated
 

University, Oak Ridge, Tennessee.
 

MR. ESPINOSA: I’m Richard Espinosa with
 

Johnson Controls Northern New Mexico, Sheet Metal
 

Workers Local 49, Shop Steward Union Trustee.
 

DR. MELIUS: I’m Jim Melius. I’m a
 

physician with the Laborors’ Union in New York.
 

DR. ZIEMER: Thank you.
 

Those are the ten members of the Board,
 

including I’m one of the ten, so there’s ten of
 

us.
 

And then let me introduce the individual who
 

is the lead staff person and serves as Executive
 

Secretary for this Board, and that’s Larry
 

Elliott, who’s Director of the Office of
 

Compensation Analysis and Support, NIOSH —
 

National Institute for Occupational Safety and
 

Health — which in turn is part of the Centers for
 

Disease Control, which in turn is part of Health
 

and Human Services, which in turn is part of the
 

U.S. Government, and so on.
 

Larry. Would you please introduce your
 

staff who are here, or let them introduce
 

themselves.
 

MR. ELLIOTT: Sure.
 

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I think we have — they’re all outside,
 

perhaps. Oh, here’s Cori. Cori Homer, who’s
 

Committee Management Specialist; and Nichole
 

Herbert is coming; here’s Martha DiMuzio, who’s a
 

Program Analyst in my office; and then Nichole
 

Herbert, who’s my secretary, who’s helping us out
 

here today; and Ted Katz, who’s Policy Analyst in
 

the Institute. And I think that’s all of the
 

NIOSH staff that are here right now.
 

We also have our writer/editors, Marie
 

Murray and Kim Newsom.
 

DR. ZIEMER: We have a number of other guests
 

and observers here today. We welcome you.
 

I might ask if you have not already done so
 

and wish to address the Board during the public
 

comment portion, there is a sign-up book and we
 

ask you to sign up. We do that mainly so we can
 

allot the time fairly amongst those who wish to
 

make public statements for the record.
 

We would also like to learn who you are.
 

And perhaps if I can ask you all to speak loudly,
 

simply stand and introduce yourself, who you are
 

and where you’re from, and we’ll try to catch the
 

names here if we can. Thank you.
 

Start right here, and just move across.
 

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MR. SHAW: Good morning. I’m Roger Shaw
 

with the law firm of McCarter & English out of
 

Newark, New Jersey.
 

MR. ELLENBERGER: I’m Jim Ellenberger. I’m
 

a consultant with PACE International Union, the
 

single largest union that represents workers in
 

the nuclear weapons complex, and our union is not
 

represented on this panel.
 

MS. DE PEYSTER: Good morning. I’m Frances
 

de Peyster. I’m the Deputy of the CDC Washington
 

Office, around the hall from NIOSH, and I’m here
 

as an observer.
 

DR. ZIEMER: Thank you. Welcome.
 

MS. DAVIS: I’m Allison Davis. I’m the CIO
 

Administrative Officer for NIOSH.
 

MS. KELLEY: I’m Alice Kelley. I’m with the
 

Office of General Counsel for CDC at DHHS.
 

MS. KUYKENDALL: Good morning. I’m Helen
 

Kuykendall from CDC’s Committee Management
 

Office.
 

DR. ZIEMER: Incidentally, some of these
 

folks are actually on the program, so you’ll hear
 

from them again.
 

MS. ARMSTRONG: I’m Mary Armstrong. I’m
 

with the Office of General Counsel for CDC.
 

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MR. GIBSON: I’m Mike Gibson. I’m Vice
 

President of the Atomic Workers Energy Council,
 

who represents a lot of DOE sites and atomic
 

workers at those sites.
 

DR. ZIEMER: Thank you.
 

MR. GRIFFIN: I’m Mark Griffin, a Health
 

Physicist consultant with PACE International
 

Union.
 

MS. MARTIN: I’m Fay Martin from Oak Ridge,
 

with the Local Oversight Committee and Citizens
 

Advisory Panel.
 

MS. LEVINE: I’m Sonya Levine from the
 

Solicitor’s Office with the Department of Labor.
 

MS. TOUFEXIS: I’m Rose Toufexis. I’m also
 

with the Solicitor’s Office in the Department of
 

Labor.
 

MR. NESVET: Jeff Nesvet, Solicitor’s
 

Office, Department of Labor.
 

MR. TURCIC: Pete Turcic, the Director of
 

the Energy Employees Occupational Illness
 

Compensation Program, Department of Labor.
 

DR. MICHAELS: My name is David Michaels.
 

I’m at George Washington University School of
 

Public Health, and a consultant to the Department
 

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of Labor.
 

MR. KOTSCH: I’m Jeff Kotsch. I’m the
 

Health Physicist for Pete’s group at the
 

Department of Labor.
 

MR. TABOR: I’m Robert Tabor. I’m from
 

Fernald Atomic Trade and Labor Council, Fernald
 

Lab.
 

MR. HILL: I’m Jeff Hill, a 27-year employee
 

at Oak Ridge National Laboratory. I’m also one
 

of the Atomic Trade and Labor Council
 

Environmental Health and Safety representatives.
 

I’m glad to see labor on the Board.
 

MR. LIVERMAN: I’m Jim Liverman. I’m a
 

consultant to the Defense Nuclear Facilities
 

Safety Board (inaudible).
 

MR. BURNFIELD: Dan Burnfield. I’m a Health
 

Physicist for the Defense Nuclear Facilities
 

Safety Board.
 

DR. ZIEMER: Okay. I think we may have had
 

one or two others come in after we got underway.
 

Did we miss anyone?
 

Yes, in the very back, just walked in. Can
 

you introduce yourself? We’re introducing
 

everybody.
 

MS. HOMOKI: Liz Homoki, Office of General
 

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Counsel.
 

DR. UTTERBACK: I’m David Utterback with
 

NIOSH.
 

DR. ZIEMER: And if the bus lady comes in to
 

change the coffee we’ll introduce her as well.
 

Very good.
 

Please consider yourself introduced to
 

everyone else here, and certainly during the
 

breaks if you want to have exchanges, consider
 

yourselves introduced.
 

Let me ask if everyone has received an
 

agenda. Is there anyone who did not get an
 

agenda? There are copies on the table. Just
 

take a moment and grab one if you do not have
 

one.
 

I’m now going to switch positions here, and
 

we have a number of presentations which in a
 

sense are in the form of orientation for the
 

Board itself.
 

And Larry, if you would introduce our first
 

speaker at this point, then we’ll proceed.
 

MR. ELLIOTT: Good morning again. This is
 

Larry Elliott, and we do have an opening session
 

right now with Helen Kuykendall from the Office
 

of Committee Management, Centers for Disease
 

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Control, to give a brief presentation to the
 

Board about the public law that establishes
 

advisory committees.
 

And you’re going to have to bear with me
 

while I get this started back up, Helen, so tell
 

your best joke.
 

MS. KUYKENDALL: Oh, my goodness. I didn’t
 

know that was going to be a requirement. It’s
 

not, according to FACA.
 

I do want to say welcome to the first and
 

long-awaited meeting of the Advisory Board on
 

Radiation and Worker Health. I do work with
 

CDC’s Committee Management Office, and according
 

to FACA, each agency must have a Committee
 

Management Officer, and that person for CDC is
 

Burma Burch. We have responsibility for
 

providing overall guidance and management for
 

CDC’s Federal Advisory Committees to ensure
 

compliance with applicable laws and regulations.
 

We work closely with NIOSH officials and with OCG
 

staff to help the Board do business according to
 

the requirements of the Federal Advisory
 

Committee Act.
 

And I know that you all want to get down to
 

business as quickly as possible, so I will try
 

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not to take up too much of your time this
 

morning. But I do want to give you just a very
 

brief overview of the purpose for and
 

requirements of FACA. And also I think Mary is
 

going to share a video with you that will give
 

you a little bit more detail about the
 

requirements of FACA and about your
 

responsibilities as a special government
 

employee, a member of the Advisory Board on
 

Radiation and Worker Health.
 

And Dr. Ziemer, I was very impressed with
 

your grasp of the way the system works and the
 

way the flow goes. And this morning after the
 

video and this presentation, you probably will
 

know everything about FACA, more than you ever
 

wanted to know but were afraid to ask because you
 

were afraid you would fall asleep. And there is
 

that slide up there somewhere.
 

DR. ZIEMER: Helen, could I ask, as you
 

proceed do you want Committee members to ask
 

questions as you present, or wait til the end?
 

MS. KUYKENDALL: It doesn’t matter. Probably
 

— I will say that because the video does go into
 

more specific detail that a lot of your questions
 

may be answered after that point in time. So if
 

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you’d like —
 

DR. ZIEMER: That would be good.
 

MS. KUYKENDALL: The Federal Advisory
 

Committee Act was enacted by Congress, Public Law
 

92-463, in October of 1972. Congress decided to
 

establish a system for the creation and operation
 

of advisory committees in the Federal branch — in
 

the Executive Branch of the Federal government.
 

Congress created FACA to enhance accountability
 

of advisory committees to the public to protect
 

against undue influence of special interest
 

groups and to reduce costs associated with the
 

operation of advisory committees.
 

A committee is considered subject to the
 

requirements of FACA when it is established by
 

the Federal government, and that can be either by
 

statute mandated by Congress; it can be
 

established at the discretion of the head of an
 

agency; or, in this case, by the President.
 

Actually this is by statute, but the members are
 

appointed by the President.
 

The Federal government controls the
 

activities of the committee, and committee
 

members are other than full-time or part-time
 

Federal employees. If the committee advises the
 

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government and gives consensus advice —
 

individuals can give advice to the Federal
 

government, and if it is individual advice it is
 

not considered subject to the requirements of
 

FACA. But if it's consensus advice it falls
 

under the Federal Advisory Committee Act. And
 

the committee must have a specific purpose,
 

organized structure, and fixed membership.
 

FACA defines a Federal advisory committee as
 

any committee, board, commission, council,
 

conference, panel or task force that is
 

established or utilized by the Federal government
 

for the purpose of obtaining consensus advice or
 

recommendations on issues or policies.
 

The Advisory Board on Radiation and Worker
 

Health, as Dr. Ziemer has already pointed out,
 

was mandated by Congress, Public Law 106-398, to
 

advise the President on the development of
 

guidelines for making determinations related to
 

radiation exposure of DOE facility employees who
 

have specified cancer as stated in the law, and
 

to advise on the scientific validity and quality
 

of dose estimation and reconstruction efforts
 

being performed for purposes of the compensation
 

program. It's to advise on the feasibility of
 

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adding classes to the Special Exposure Cohort and
 

other matters related to radiation and worker
 

health in DOE facilities considered appropriate
 

by the President.
 

And I know that Larry and other NIOSH
 

officials probably are going to go into more
 

detail about the functions for the Board, so I
 

won't do that this morning.
 

The governing authorities for the Advisory
 

Board are, of course, FACA and the Energy
 

Employees Occupational Illness Program Act;
 

Executive Order 13179, which delegated
 

responsibility for the Board to the Secretary of
 

HHS, who further delegated it to CDC and NIOSH.
 

The Board is also governed by GSA, General
 

Services Administration, regulations which was in
 

1977 given oversight responsibility for Federal
 

advisory committees; and it is also governed by
 

some department and agency policies.
 

FACA requires that a committee be chartered,
 

that it have balanced membership, and that its
 

meetings be open to the public, according to the
 

government in the Sunshine Act. And FACA also
 

requires that detailed minutes of each meeting be
 

kept, and must contain the date and location of
 

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the meeting, a record of persons attending —
 

which is why, if you signed in, that's why, and
 

another reason that we introduce ourselves; and
 

FACA — the detailed minutes must contain a
 

complete and accurate description of matters
 

discussed and conclusions reached, and contain
 

any advice or recommendations provided by the
 

committee.
 

FACA also says that committee documents must
 

be made available to the public for copying as
 

long as the committee exists. So all of the
 

documents that are shared with you today must be
 

maintained, usually by the designated Federal
 

official or executive secretary, and those terms
 

are interchangeable. So all of these documents
 

will be available as long as the committee is in
 

existence.
 

FACA says that committee membership will be
 

fairly balanced in terms of points of view
 

represented and functions to be performed, and
 

its members are appointed as special government
 

employees and must comply with the conflict of
 

interest statutes. And the video will go into a
 

little bit more detail about that, and Mary
 

probably also will be talking about that.
 

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Members serve on advisory committees generally
 

for overlapping terms up to four years, but in
 

this case, I believe, with the Advisory Board,
 

the President chose to make appointments for one
 

year initially.
 

Okay. And I see you all are still with me.
 

The structure of the committee is the
 

designated federal official or the executive
 

secretary, the chair, and the members. And the
 

responsibilities of the DFO are to supervise the
 

day-to-day operations of the committee, to
 

approve meeting agendas, to attend all committee
 

meetings — the Advisory Board cannot meet without
 

a designated federal official — and the DFO must
 

ensure that all committee meeting notices are
 

published in the Federal Register at least 15
 

days in advance of the advisory board meeting.
 

The DFO can also adjourn committee meetings when
 

he determines that it is in the public interest
 

to do so, and he can chair the meeting when
 

directed to do so.
 

The responsibilities of the committee chair
 

or board chair are to preside over the committee
 

meetings and to ensure public participation, and
 

the committee chair is also responsible for
 

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certifying the accuracy of the meeting minutes.
 

I would also like to say that the DFO and the
 

committee chair usually work very closely
 

together in developing the agenda and deciding on
 

how the meetings will be conducted. It's helpful
 

to determine that in advance so that you can
 

maximize the use of the committee's time and
 

facilitate the meetings.
 

A special government employee — and if you
 

all got the standards of ethical conduct for
 

employees in the Executive Branch and completed
 

your confidential financial disclosure report
 

form, which is required in order for you to
 

attend this meeting, you know that you are a
 

private citizen appointed by, in this case, the
 

President. But generally speaking, special
 

government employees are appointed by the agency
 

head or the secretary, as well as the President.
 

And you have been appointed based on your
 

expertise that will contribute to the committee's
 

objectives, and you serve with or without
 

compensation for 130 days or less a year, and in
 

this case your charter says that you receive
 

compensation. And you are here to provide your
 

personal opinion only, and you are not the voice
 

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of your organization. You are here to give your
 

opinion based on your knowledge and expertise of
 

the issues, and you are legally held accountable
 

for ethical issues, particularly financial
 

interests.
 

This next slide shows a little bit of the —
 

gives you an idea of the management for federal
 

advisory committees. The designated federal
 

official works with you and communicates with my
 

office, the Committee Management Office. And we
 

work, as I said earlier, very closely with OCG in
 

the operation of your committee and with other
 

matters related to the committee — the charter
 

establishment, your recharter, which will happen
 

in two years. And we also work very closely with
 

the Office of the Secretary and the department
 

committee management officer there, who is in the
 

office of the White House Liaison; and that
 

office works very closely with the White House.
 

And as I said earlier also, GSA has
 

oversight responsibility for the Federal Advisory
 

Committee Act, and FACA requires that the
 

President make an annual report to Congress of
 

all of the committee activities and costs. So we
 

will look to NIOSH officials to provide us
 

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information about the administrative work of the
 

committee and the cost, and we in turn will
 

provide that to the Secretary's office, who in
 

turn provides that to GSA. And then GSA prepares
 

the report for the President to Congress.
 

If you would like more information about
 

Federal Advisory Committee Act, the law,
 

applicable laws, the GSA Final Rule, there's a
 

wealth of information at GSA's web site,
 

gsa.gov/committeemanagement. It also gives
 

information about all of CDC's and HHS's advisory
 

committees.
 

Thank you.
 

DR. ZIEMER: Thank you very much.
 

We did indicate that we would perhaps defer
 

questions, but if there is a pressing question
 

that any member of the Board has, let me give you
 

the opportunity to raise that question now.
 

[No responses]
 

DR. ZIEMER: If not, we will proceed. We're
 

way ahead of schedule, which usually is pretty
 

good, allows the Chair to insert more jokes if
 

necessary.
 

We do have the video. Now is that video
 

next? Some of the other official welcomers are
 

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not yet here to welcome us, I think is going to
 

be the problem there. Let me look here a moment.
 

Time out.
 

I think we'll be all right. Let's proceed
 

with the video, if it's ready.
 

[Whereupon, the video entitled
 

“FACA — The First Meeting” was
 

shown.]
 

DR. ZIEMER: Okay, now we’ll open the floor
 

and see if any of the Board members have
 

questions to direct to Helen.
 

Helen, are you still here?
 

MS. KUYKENDALL: Yes.
 

DR. ZIEMER: Thank you.
 

[No responses]
 

DR. ZIEMER: It appears that the
 

presentation was either completely clear — I'll
 

leave it at that, it was completely clear. Thank
 

you.
 

Then we'll move on to the next item on the
 

agenda. We have some particular members of the
 

agency, of HHS and NIOSH and Department of Labor,
 

that we want to introduce and give them the
 

opportunity to make some remarks.
 

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I'm going to ask Larry Elliott if he would
 

introduce these guests this morning.
 

MR. ELLIOTT: Yes, we're certainly pleased
 

to have Mr. Claude Allen here from the Department
 

of Health and Human Services, Deputy Secretary;
 

and Director of Occupational Worker — am I
 

getting this right? — OWA, Shelby Hallmark from
 

Department of Labor; and Kathleen Rest, who's the
 

Acting Director of NIOSH. And I think we have —
 

if you want to take the front, we have places for
 

you.
 

Claude Allen, then, will begin.
 

MR. ALLEN: Good morning. Let's try that
 

again. Good morning. I know, it's a little
 

difficult after watching an ethics video, having
 

to do that every year.
 

Just as a bit of advice for you, if you have
 

questions, do ask. The rules are very
 

complicated, but they can be simplified by asking
 

simple questions to our counsel staff. I
 

certainly have to do it just about every day of
 

the year, whenever I — whether I'm traveling or
 

meeting with someone in the office. Just keeping
 

in touch with them is very helpful.
 

But I do want to reassure you that in many
 

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ways complying with the ethics rules is very
 

simple if you keep a very simple rule of thumb,
 

and that is if it doesn't seem right, you'd best
 

ask before you take the next step. But also it
 

should not prevent you from carrying out your —
 

not only your duties in serving as a Special
 

Government Employee, but also in your day-to-day
 

operations.
 

In fact, we labored long and hard over your
 

nominations to this Advisory Committee. I was
 

directly involved on behalf of the Secretary in
 

overseeing that process, and so we do know much
 

about you. And it's nice to finally get here to
 

welcome you here to this effort.
 

First, let me start off again by first
 

welcoming you and thanking you on behalf of
 

Secretary Tommy Thompson. It's been an honor to
 

work with so many other important agencies — the
 

Department of Labor, Department of Energy, and
 

our agencies within the Department of Health and
 

Human Services — to try to come to grips with a
 

challenge that we all have, and it's been a
 

cooperative effort.
 

In fact, just to give you an idea, I meet
 

with — via conference call — at least once a
 

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month with my counterparts, the Deputies at the
 

Department of Labor and Department of Energy, to
 

talk about these very issues to sort through some
 

of the challenges that we confront, some of the
 

sometimes differing opinions that may exist
 

between the agencies on what we should be doing.
 

And we seem to be able to resolve those very
 

readily in that meeting. So I do spend time
 

looking at this very important issue.
 

I also want to appreciate your commitment in
 

bringing your special talents and your skills to
 

bear on serving not just the government, but also
 

serving those families and those individuals and
 

survivors of individuals who've worked for our
 

nuclear industry and work in weapons programs.
 

Indeed, I need not remind you that in a time like
 

this we are busy right now looking at our
 

bioterrorism preparedness and at how we would
 

respond to not only bioterrorism in terms of
 

biological and chemical, but also radiological
 

and nuclear.
 

And so therefore the work that you're doing
 

very much enables this government to fulfill its
 

obligation to those who serve. And so I want you
 

to realize the high importance that we place on
 

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the roles that you serve in serving on this
 

Advisory Committee. You bring to this program
 

the views and the expertise of workers and
 

independent scientists and physicians, and that
 

is what we've looked at very carefully as we
 

constructed the Board, which was very specific in
 

its makeup.
 

We're asking you to advise us on the
 

policies we're establishing for current and
 

potential cancer claimants under the new
 

compensation program. And we're also asking you
 

to advise us on decisions whether to add worker
 

groups to the Special Exposure Cohort. I've
 

learned a lot about this over the last few
 

months, more than what I had anticipated in this
 

job, but it has been a very important component,
 

and that is what groups of individuals qualify
 

for coverage. We also are asking you to help us
 

ensure the quality of our radiation dose
 

reconstruction program at NIOSH. They will be
 

focusing on quite a number of applications that
 

come through, and so we're asking you for your
 

expertise there, as well.
 

Larry Elliott, the Executive Secretary, will
 

review the responsibilities of the Board with you
 

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in detail. I wanted just to share with you again
 

that our aim at HHS is to earn the public's
 

confidence in this important new program, and to
 

meet high standards of medicine and science as
 

far as possible while ensuring that claimants and
 

their survivors are given fair, timely and
 

practical service. This Committee has a key role
 

in achieving these aims.
 

And again, as Secretary Thompson has made it
 

very clear in our Department that we are one
 

department, notwithstanding the fact that we have
 

many agencies or many components of it; but we
 

are also one administration, so we want to work
 

very cooperatively with the Department of Labor
 

and the Department of Energy in arriving at the
 

very best that we can provide to these families
 

and survivors in terms of their claims.
 

So I again want to thank you on behalf of
 

Secretary Thompson for your decision to serve.
 

We appreciate your accepting this invitation.
 

And please do not hesitate, if we can provide you
 

with any service from the Department itself, to
 

contact us through Larry or anyone else here
 

who's serving you in that capacity, as to
 

assistance or advice. So again, thank you again
 

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for your commitment and your dedication to this
 

effort. Appreciate it.
 

DR. ZIEMER: Thank you very much, Mr. Allen.
 

Now let us call on Dr. Rest to address the
 

group.
 

DR. REST: Good morning to all of you, and I
 

extend my personal welcome to you on behalf of
 

the National Institute for Occupational Safety
 

and Health.
 

In joining this Board you really have
 

assumed a vitally important role for advising HHS
 

and CDC/NIOSH on its responsibilities under this
 

new compensation program. We recognize that this
 

is no small commitment on your part, and so I'm
 

here to thank you up front today for the
 

contributions that you're going to make to this
 

very important effort.
 

As you know, Congress established this
 

program to provide timely, uniform and adequate
 

compensation for the men and women who worked in
 

this country's nuclear weapons program and
 

sustained occupational diseases as a result of
 

their work. These dedicated workers labored long
 

and hard on behalf of this nation, and we owe
 

them a great debt. For those who've become ill
 

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in the performance of this work, we need to work
 

together very hard to ensure that we effectively
 

implement the program that Congress has created
 

to help compensate them.
 

As you know, the Energy Employees
 

Compensation Program Act named NIOSH to assist
 

the Department of Health and Human Services in
 

carrying out its responsibilities because of its
 

— of the integrity and the excellence of its
 

scientific expertise. As just noted by Deputy
 

Secretary Allen, these responsibilities include
 

making new policies to implement the program and
 

building new programs to assist claimants, the
 

Federal Compensation Program at the Department of
 

Labor, and the Office of Worker Advocacy at the
 

Department of Energy. HHS will be relying on
 

NIOSH to take the lead in implementing and
 

carrying out the major responsibilities assigned
 

to HHS under this Act.
 

Now as those of you who know NIOSH probably
 

realize, involvement in a compensation program is
 

a new role for us at NIOSH, which is the primary
 

Federal agency conducting research and prevention
 

activities in occupational safety and health.
 

NIOSH does have substantial expertise in this
 

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area, however, as it's conducted epidemiologic
 

research for many years addressing health risks
 

to DOE workers. Now we at NIOSH feel very
 

honored to have been entrusted with these new
 

responsibilities, and I want to assure all of you
 

that we have made it a top priority for us.
 

We're working really hard to make this program
 

successful and to get it fully launched as
 

quickly as possible.
 

To date, and in the short time that the
 

program has been up and running, NIOSH has
 

accomplished a number of things. We've
 

established the Office of Compensation Analysis
 

and Support within NIOSH with Larry Elliott as
 

the Director of that office, now located in
 

Cincinnati. We've staffed — we've begun to staff
 

up this office with a very impressive technical
 

and scientific team, as well as a group of
 

dedicated support staff.
 

We've established records facilities,
 

systems and procedures for the dose
 

reconstruction program. We've developed an
 

interim final rule on dose reconstruction and a
 

notice of proposed rule-making on the probability
 

of causation. We've developed a web site that I
 

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hope you've all logged onto. We've adapted
 

existing software for probability of causation
 

calculations and internal dose estimation. We've
 

issued an RFP for a dose reconstruction program,
 

appointed physicians to serve as panelists — as
 

members of medical panels serving the DOE Office
 

of Worker Advocacy. We've begun to receive
 

cancer claims from the Department of Labor and
 

begun the process of dose reconstruction.
 

And we're responsible for staffing and
 

funding this Advisory Board. And I'm here to
 

assure you that we will do our very best at NIOSH
 

to provide you with the support and the resources
 

that you need to fulfill your own significant
 

responsibilities under this program. We
 

recognize the enormous commitment that you've
 

made, and we certainly look forward to working
 

with you in the coming months.
 

Now our aim as part of this program, the
 

compensation program, is to serve the nuclear
 

weapons workers and their survivors as well as
 

possible. With your advice, we have to establish
 

HHS policies and decisions that are fair to
 

workers and their survivors, that are grounded to
 

the extent feasible in good sound science, and
 

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that are practical and timely. With your advice,
 

we have to achieve a dose reconstruction program
 

that meets those high standards and serves the
 

critical needs of claimants and the Department of
 

Labor.
 

Now in working with you, the Board, I can
 

tell you that we are committed to helping you
 

fulfill your responsibilities. Working
 

collaboratively with you and with our sister
 

agencies to assure efficient and effective
 

implementation of this program, we will give you
 

the support that you need, and we are certainly
 

committed to open and honest communication
 

throughout this process.
 

So again, on behalf of NIOSH, I want to
 

thank you for joining in this important endeavor,
 

and we certainly look forward to working with you
 

in the coming months.
 

DR. ZIEMER: Thank you very much. And Dr.
 

Rest, will you be able to stay with us a little
 

while, at least through the break, so committee
 

members can meet you?
 

DR. REST: I'll be with you through the
 

break.
 

DR. ZIEMER: Thank you very much. I should
 

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note this meeting would become very restless if
 

you left.
 

Okay. Mr. Hallmark, please.
 

MR. HALLMARK: Thank you. It's my pleasure
 

to join with Secretary Allen and Dr. Rest to
 

welcome you in your role as the Advisory
 

Committee on this very important topic today.
 

I'd like to just congratulate you for having
 

been selected for this activity and, as the two
 

previous speakers, thank you for accepting it.
 

It's going to be a difficult task, but I assume,
 

given your background and the interest that you
 

bring, that you'll be able to achieve great
 

things in this role.
 

It is going to be challenging. Usually
 

advisory committees are focusing their help on
 

one particular part of the government. This
 

particular program gives you the opportunity to
 

address three or four Cabinet-level departments,
 

and is rather unique in that regard.
 

We are the Department of Labor, the agency
 

that was given lead responsibility in actually
 

implementing the Federal part of the Energy
 

Employees Occupational Illness Compensation
 

Program Act. We did not name the program; I want
 

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the record to show that. Congress is responsible
 

for that. But we call it affectionately EEOICPA,
 

so if you'd like to get used to that acronym,
 

you're going to hear it.
 

We are obviously, as the entity that's
 

responsible for taking and adjudicating claims,
 

we're vastly interested in what you do and the
 

effectiveness and quality and speed with which
 

you do it, because all of those things will
 

affect us. And I'll talk a little bit more about
 

that as I go on.
 

The Department of Labor has the
 

responsibility for, as I said, adjudicating the
 

Federal benefit program under this statute. That
 

involves our issuing lump sum payments and
 

medical benefits for those who are found to be
 

eligible. It requires us to provide an
 

administrative appeal process for those who
 

disagree with our decisions. And ultimately we
 

would be involved with the Department of Justice
 

in defending those decisions in court for those
 

who are still aggrieved after they've gone
 

through our process.
 

We're eager to see the results of the
 

Board's deliberations, primarily, I should say,
 

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because until HHS can complete the work on their
 

probability of causation rule, with your input
 

and review, we won't be able to address thousands
 

of cases that are already in hand. And that's a
 

matter of grave concern to the agency that has
 

those cases in hand, and people know our address.
 

So we're interested in getting this process
 

moving.
 

The other piece is that the Board has the
 

responsibility to advise HHS and NIOSH with
 

regard to their dose reconstruction process, and
 

with regard to the expansion process for the so-


called Special Exposure Cohort. It's very
 

important for all the agencies involved that
 

those processes are strong, they're reasonable,
 

they are understandable to the public that's
 

interested in this, so that we can have a
 

credible program and one that everyone is proud
 

to administer.
 

Just to let you know a little bit about what
 

the Department of Labor has been up to since this
 

program went into effect, we published our
 

interim final regulation back in May, and that
 

allowed us to begin taking claims and
 

effectuating this program on the date required by
 

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Congress, which was July 31st, 2001. We had put
 

in place a benefit claims structure analogous to
 

others, other parts of the Department of Labor.
 

By the way, Larry, I’m with the Office of
 

Worker's Compensation Programs. The Office of
 

Worker Assistance is over in that other program
 

at Department of Energy.
 

We have — we've got 150 Federal employees in
 

place now in four district offices around the
 

country in Seattle, in Denver, in Jacksonville,
 

Florida and in Cleveland, Ohio; and a national
 

office staff including our Final Adjudication
 

Branch, which is the ultimate deciding body for
 

us.
 

We’ve put in place, along with the
 

Department of Energy, ten resource centers in the
 

major sites that DOE weapons facilities are
 

located in, and those have been up and running
 

since July also. And we've established a process
 

of outreach, which has led us to do town hall
 

meetings on more than 60 occasions, and we've
 

done a number of traveling resource centers where
 

we send people out to locations where we don't
 

have currently a formal office to help people
 

file their claims. So we've got a lot of
 

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outreach going on. We're trying to reach the
 

public who may be interested in filing this type
 

of claim.
 

As of last Thursday, January 17th, we had
 

18,061 claims, so you can see the program is
 

real. It's growing, and it will continue to
 

grow.
 

Many of the claims that we have in hand are
 

ones that Department of Labor has the authority
 

and responsibility to take all the way to the end
 

at this point. Those include those Special
 

Exposure Cohort cases, individuals who have
 

radiation-induced cancers of a kind listed in the
 

statute, and who worked in a facility where the
 

statute provides us with a presumption that there
 

was occupational linkage to that particular
 

condition. So those Special Exposure Cohort
 

cases we can take to the end.
 

Beryllium exposure cases we can adjudicate
 

and make a final decision on; silicosis cases for
 

those who are miners involved in digging tunnels
 

for tests; and the supplemental benefit program
 

for those who will receive benefits from the
 

Department of Justice under the Radiation
 

Exposure Compensation Act — that's not a piece of
 

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the statute that you have direct contact with.
 

But those are the four areas where we can take
 

the case and go all the way to the end.
 

And in six months, and actually less than
 

six months since this bill became effective, we
 

have made a good start, I believe, in trying to
 

address those cases where we have that full
 

responsibility. We've made 2,500 what we call
 

recommended decisions in those four district
 

offices. We've made 1,570 final decisions in our
 

final branch, final adjudication branch. And
 

we've made 1,044 lump sum payments to injured
 

workers and their survivors, and clearly that is
 

a substantial number. It's not as many as we'd
 

like, but it is a good beginning, I believe,
 

given the start-up requirements involved in this
 

kind of a major entitlement program.
 

But the majority of the cases that we have
 

in hand, and clearly the majority that we expect
 

to get over the next several years, are cases
 

that involve a radiation exposure and a claim of
 

cancer caused by radiation exposure where NIOSH
 

will have to do a dose reconstruction. That set
 

of cases is going to require an intricate level
 

of interaction and cooperation between the
 

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Department of Labor and HHS, and is the source of
 

a lot of our interest in how you do your work and
 

the kind of advice you provide.
 

Specifically, just to give you a notion of
 

the degree to which we have to interact closely
 

with HHS, the process involves something like the
 

following. We receive the claim and screen the
 

claim to determine whether the individual was a
 

DOE worker and has one — has a cancer. Having
 

done that, we refer the case to NIOSH for a dose
 

reconstruction. NIOSH completes that
 

reconstruction, returns the case to DOL. DOL
 

then adjudicates the case, makes a final decision
 

based on the exposure report that we get from
 

dose reconstruction and on HHS's probability of
 

causation regulation. And having done that, if
 

the claimant has objections or concerns, we may
 

have to send the case back to HHS to reconsider
 

that dose reconstruction. So you can see cases
 

will be going back and forth between the two
 

agencies, and that's the reason I suspect why I'm
 

here today talking with you at a HHS-sponsored
 

operation.
 

We are — I'm happy to report that that level
 

of cooperation that's going to be needed to
 

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implement this program has in fact been working
 

very well in the early going here. We have had
 

very good relationships and working coordination
 

with HHS, and I'd like to congratulate NIOSH for
 

the work they've done so far in terms of putting
 

together their regulations and their procedures
 

for going forward. This is an intensely
 

difficult undertaking, and as Kathy had
 

mentioned, not an area that NIOSH has been
 

familiar with in terms of processing individual
 

claims. The Department of Labor does that kind
 

of work and NIOSH has not, historically, and it's
 

been quite gratifying to see how quickly and how
 

professionally NIOSH has moved ahead in that
 

process.
 

We are, as mentioned, in the process of
 

sending cases over to NIOSH. Fifteen hundred
 

cases are there so far which require dose
 

reconstruction. Another 1,500 cases will
 

probably be delivered by April, which is the goal
 

that NIOSH has for getting their regulation in
 

place. And until that regulation is in place and
 

effective, even though the dose reconstruction is
 

complete, Department of Labor can't act on the
 

case because we have no basis for making a
 

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decision about probability.
 

So that's where your input comes in. That's
 

where the urgency, the rubber meets the road, as
 

far as this panel is concerned. It's not an
 

academic exercise. There are already 1,500;
 

there'll soon be 3,000 cases, individuals. These
 

are workers or their survivors who have incurred
 

a very serious or fatal disease, all of whom are
 

currently waiting, more or less patiently —
 

hopefully patiently — for this process to be
 

elaborated and then to work for them.
 

We are also waiting patiently, and hopefully
 

we'll be working with you. If the Board needs
 

help from the Department of Labor with respect to
 

our specific part of this, we'll be glad to
 

provide any information you might need. It's a
 

difficult task, as I said earlier. I again
 

commend you for taking it on, and I know that the
 

nuclear workers who suffered these exposures
 

deserve your serious and best efforts.
 

Thank you very much.
 

DR. ZIEMER: Thank you very much, Mr.
 

Hallmark. And I assume that you might be here
 

for a while, and perhaps we'll have a chance to
 

chat with you during the break, at least?
 

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MR. HALLMARK: Absolutely.
 

DR. ZIEMER: Thank you.
 

Might I — we'll allow a few minutes for some
 

questions here. Let me pose one to start with.
 

Would I be putting you on the spot to ask
 

you to identify the ten resource centers that DOL
 

has established around the country?
 

MR. HALLMARK: Not at all. I'll speak into
 

the microphone here. We have with DOE
 

established the centers, starting — I think our
 

first one went up in Paducah, Kentucky. There
 

are ten centers around the country — Hanford; Las
 

Vegas; Rocky Flats, Colorado; Paducah; Oak Ridge;
 

Savannah River, South Carolina — okay, now you've
 

— now I'm starting to slow down here —
 

DR. ZIEMER: Los Alamos?
 

MR. HALLMARK: Los Alamos, yes.
 

UNIDENTIFIED: Idaho.
 

MR. HALLMARK: And the national — thank you
 

back there, Rick.
 

UNIDENTIFIED: Portsmouth.
 

MR. HALLMARK: And Portsmouth, Ohio. How
 

could I forget Portsmouth? Okay.
 

So I think that's nine, and we have
 

Anchorage, Alaska, which is a smaller site that's
 

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run by employees who are in the former worker
 

program up there.
 

DR. ZIEMER: Thank you very much.
 

MR. HALLMARK: And we've done traveling
 

centers where we send those people from those
 

offices out to do the same kind of work in
 

several different places — Southern California;
 

Buffalo area of New York; Reading, Pennsylvania;
 

western Pennsylvania, and on several occasions to
 

the Amarillo area where Pantex is.
 

DR. ZIEMER: Let me ask if other Board
 

members have questions.
 

Yes, Dr. DeHart?
 

DR. DeHART: If you can, do you have a
 

crystal ball guess as to how many claimants there
 

will be by the time the program runs its course?
 

MR. HALLMARK: I think that would be very
 

difficult to guess. We had initially estimated
 

at Labor something like 80,000 claims in the
 

first two years. That probably was a little high,
 

based on what we've received in the first six
 

months here. However, I think it's a little
 

early yet to say.
 

As you know, Congress has recently amended
 

the statute to broaden the definition of
 

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survivor, among other important sort of fixes,
 

and also addressing themselves to people who have
 

tort claims and how they need to proceed with
 

their tort claims in light of possible
 

eligibility under the EEOICPA benefit program.
 

Both of those may have an impact of bringing
 

people in who had been reluctant to come forward
 

or who thought they were not covered. In the
 

case of survivors, very clearly adult children,
 

so-called, were clearly disallowed by the
 

language of the previous statute.
 

So we expect — we're seeing something like
 

500 or 600 claims per week coming in now. We
 

expect that perhaps to grow, and we could see as
 

many as 75,000 in the first two years. And then
 

it's an ongoing program. As people incur these
 

diseases that are covered under the Federal
 

statute, they will become eligible over time.
 

And obviously, since the statute covers cancer
 

and cancer applies — visits the lives of a very
 

high percentage of the American population, we
 

can expect this program to continue for a long
 

time.
 

DR. ZIEMER: Other questions either for Dr.
 

Rest or Dr. Hallmark? Yes.
 

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DR. ANDERSON: Of the 1,000 lump sum
 

payments, what's been the average payment?
 

MR. HALLMARK: The lump sum payments are
 

established by Congress, and they are $150,000
 

for the individuals in this cohort. They are
 

$50,000 for the supplement for the RECA
 

beneficiaries, but there's no different amount.
 

It's that — unless it's —
 

DR. ANDERSON: All of these have been in the
 

150 group?
 

MR. HALLMARK: No, no. Quite a number of
 

them have been RECA supplements, because that was
 

something we could do very quickly based on the
 

Justice Department telling us, yes, these people
 

were our beneficiaries. So in fact, the majority
 

actually are RECA benefits as opposed to the
 

other.
 

DR. ZIEMER: And there it's the difference —
 

their original payments were $100,000?
 

MR. HALLMARK: These were uranium miners who
 

originally received $100,000, and the law gave
 

them the extra $50,000 as a matter of parity.
 

But we are receiving and processing claims very
 

rapidly now. And as I say, our infrastructure
 

being in place, we expect to get a lot of the —
 

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especially Special Exposure Cohort cases through
 

the system in the next few months.
 

DR. ZIEMER: And your beryllium, the numbers
 

you gave us for beryllium included the beryllium
 

sensitivities where you're covering medical care
 

as well, or —
 

MR. HALLMARK: The numbers of cases decided
 

included some beryllium cases. We would not
 

issue a lump sum payment in the case of beryllium
 

sensitivity; that's correct.
 

DR. ZIEMER: Right.
 

Other questions?
 

[No responses]
 

DR. ZIEMER: Thank you.
 

It's 10:00 o'clock. We are going to take
 

our break. Since we've already had the film on
 

committee membership it basically puts us really
 

a little ahead of schedule, so we can allow the
 

break to continue till about 20 after, give you a
 

little breathing space. So let's all take a
 

break at this time.
 

[Whereupon, a break was taken from
 

approximately 10:00 a.m. until
 

10:25 a.m.]
 

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DR. ZIEMER: Thank you, we'll come back to
 

order now.
 

Before we proceed with the agenda, just a
 

couple of items. First of all, an instruction to
 

our Board members. When you do have comments or
 

questions, it's been requested that you speak
 

into the mikes. It's important not only for our
 

recorders, but for those who are here observing
 

to hear what you are saying.
 

Secondly, if you are a visitor or observer
 

and would like to address the Board or make a
 

public comment or have items for the record, we
 

ask that you sign up. There is a sign-up book
 

out in the foyer, and if you would please sign
 

up. This is mainly so we can allow the time
 

accordingly. But I know that there are some of
 

you that have arrived since we mentioned this
 

earlier today, so this is a reminder to you if
 

you do wish to speak later when we have that
 

public comment portion of the agenda, we need to
 

have you on our roster to do so. So please sign
 

up.
 

And then I would ask if there are those of
 

you who arrived sort of mid-morning or after the
 

introduction period, we would like to learn who
 

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you are, again so we have some idea of who's
 

here. This is, after all, an open meeting. So
 

are there any of you that arrived after the
 

introduction periods of this morning that are
 

here, if you would please stand and identify
 

yourself, and tell us who you are and where
 

you're from. There are quite a few of you. This
 

is a whole new group; are we in the same meeting?
 

Okay.
 

Just start here on my left, and we'll sweep
 

across. Speak loudly so the recorder can also —
 

I know you've registered, or I assume you have,
 

but we're also recording here as well.
 

MR. SPENGLER: Thank you. Good morning. I'm
 

Bob Spengler, the Associate Administrator for
 

Science at the Agency for Toxic Substances and
 

Disease Registry.
 

DR. ZIEMER: Thank you.
 

MR. MAURO: I'm John Mauro. I'm with
 

Sanford Cohen and Associates. We're a consulting
 

firm.
 

MS. ZIMMERMAN: Trudi Zimmerman, Office of
 

Compensation Analysis and Support.
 

DR. SCHUBAUER-BERIGAN: Mary Schubauer-


Berigan, NIOSH Health-Related Energy Research
 

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Branch.
 

MR. HENSHAW: Russ Henshaw, Office of
 

Compensation Analysis and Support, NIOSH.
 

MR. SCHAEFFER: Mike Schaeffer, Department
 

of Defense, Defense Threat Reduction Agency,
 

Program Manager of the nuclear test personnel
 

review.
 

MR. MORALES: Frank Morales with the
 

Government Accountability Project.
 

MR. MILLER: Richard Miller, Government
 

Accountability Project.
 

DR. ZIEMER: Across here, go ahead.
 

DR. NETON: Jim Neton from the NIOSH Office
 

of Compensation Analysis and Support.
 

MR. SUNDIN: And I'm Dave Sundin, Deputy
 

Director of the Office of Compensation Analysis
 

and Support.
 

MR. CALHOUN: I'm Grady Calhoun, Office of
 

Compensation Analysis and Support.
 

MR. RICHARDSON: David Richardson. I'm an
 

epidemiologist at UNC Chapel Hill.
 

MR. BARAVY: Jordan Baravy (phonetic),
 

ALF-CIO.
 

DR. ZIEMER: Thank you all. Did we miss
 

anyone? Thank you for being here, and we'll
 

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proceed now with the agenda.
 

The next person on the agenda is Mary
 

Armstrong, who's with the Office of the General
 

Counsel of NIOSH. And Mary's going to come and
 

address us on some legal issues. This is again
 

some information that's very important to the
 

Board itself.
 

Mary, I know you're —
 

MS. ARMSTRONG: I'm right here.
 

DR. ZIEMER: Oh, there you are, standing in
 

the wings. Thank you.
 

MS. ARMSTRONG: I'm Mary Mitchell Armstrong.
 

I'm the Senior Attorney with the Office of
 

General Counsel assigned to NIOSH.
 

As Kathy mentioned, NIOSH is primarily a
 

research agency, the research agency for
 

occupational safety and health. And until last
 

year in October, I was the only attorney for
 

NIOSH, so this program in particular will
 

probably mean that NIOSH will have quite a few
 

more attorneys. But we are primarily — it is
 

primarily a research agency, and is also — we're
 

relatively new in the area of rule-making.
 

In addition to me, Alice Kelley — if you'll
 

stand up, Alice — is working with me, and Liz
 

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Homoki has been working with the program.
 

I'm here just to do — I talked with some of
 

you personally when we were reviewing your 450s.
 

I just wanted to emphasize again that if you have
 

any questions concerning those 450s and any
 

questions regarding anything that — as far as
 

conflict of interest, please give Larry Elliott a
 

call, and he will get to one of us and we will
 

try to answer your questions. And we've been
 

working very closely with the Office of General
 

Counsel's ethics divisions, too. So in the
 

future, if anything happens and you have any
 

questions, please do not hesitate to call.
 

But I think you've probably been fairly
 

overwhelmed with ethics this morning with our
 

film and et cetera, so I'm basically here to give
 

— just to talk briefly about the rule-making
 

process.
 

As you are aware, we have put out an interim
 

final rule on the dose reconstruction methods.
 

And as a matter of fact, NIOSH is in the process
 

of processing some dose reconstructions. We also
 

have put out a notice of proposed rule-making for
 

the probability of causation. By statute, by the
 

energy statute, you all are to provide us advice
 

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on the probability of causation, and NIOSH has
 

also requested advice on the dose reconstruction,
 

and that's the purpose of you being here today.
 

As I think you are aware, NIOSH is hoping to
 

finalize both of these regulations by early — by
 

April. As Shelby mentioned, there are many
 

claims — the cancer claims cannot be finalized
 

until the probability of causation regs are
 

finalized. So we are under a tight time frame to
 

try to get these in place, which will mean that
 

you will have to put in some extensive work
 

during that time frame, along with the Agency.
 

This meeting is being transcribed. The
 

transcript of the meeting will go into the record
 

for both rule-makings. That includes any
 

comments you make, any comments the public makes,
 

the presentations, et cetera, will all go into
 

the record for both rule-making, and we're
 

holding open the records for your
 

recommendations.
 

I wanted to emphasize, however, that we are
 

in the comment period and are here getting your
 

comments. The people who give presentations here
 

are going to try to be as responsive as possible
 

to your questions, but neither NIOSH nor the
 

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Department has made any final decisions on the
 

final contents of these rules. We're here to
 

listen to what you have to say, to listen to what
 

the public had to say previously during the
 

comment period, and to take all those into
 

advisement. And so they're — we're still in the
 

process of coming up with the final reg, and
 

nothing has been finalized.
 

Again, we appreciate you being involved with
 

this, and this is quite a challenge. We have
 

many advisory boards within HHS. There are at
 

least 168 that are just appointed by the
 

Secretary that are just discretionary, so I
 

imagine we have probably over 200 advisory boards
 

altogether. Very few of them have quite as much
 

work load as you all do, so we appreciate your
 

participation. And if you have any questions,
 

need to contact any member of my staff or me, or
 

any member of my staff, please contact Larry and
 

we'll get in touch with you.
 

Do you have any questions? Yeah.
 

DR. MELIUS: What are the dates on the
 

comment periods, and does that include the next
 

meeting of the Board?
 

MS. ARMSTRONG: The dates on the comment
 

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period is — we did not include the next period of
 

this Board. This is —
 

MR. ELLIOTT: I'll speak to that in a
 

minute.
 

MS. ARMSTRONG: Yeah.
 

DR. ZIEMER: Okay. Other questions?
 

[No responses]
 

DR. ZIEMER: Mary, you realize that our
 

agenda requires you to speak for a half-hour?
 

[Laughter]
 

MS. ARMSTRONG: Well —
 

DR. ZIEMER: Just keep going.
 

MS. ARMSTRONG: I was going to say I'm among
 

the technologically-challenged, so you didn't
 

have to sit through a PowerPoint for me because I
 

can't quite do that. So —
 

DR. ZIEMER: Thank you, we applaud you
 

there.
 

MS. ARMSTRONG: So anyway, I'm sure that
 

you'll — the less you hear from the lawyers, the
 

better.
 

DR. ZIEMER: Can you give us a timetable on
 

once the comment period closes — and I believe
 

that's this week, is it not? Or is it next week,
 

two weeks from now?
 

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MS. ARMSTRONG: The comment period for the
 

public will be closing again today — I mean,
 

tomorrow.
 

DR. ZIEMER: Tomorrow for the public, yes.
 

MS. ARMSTRONG: But for receiving the
 

Board's comments will be after —
 

DR. ZIEMER: Right. Now what's the
 

timetable, once you have the comments and you
 

have to deal with those, is there a target date?
 

Or maybe I'm getting into Larry's talk here, as
 

to when the final rule will hit the books.
 

MS. ARMSTRONG: We are hoping to have the
 

final rule, as you say, hit the books or hit the
 

street in April. This involves NIOSH having to
 

go through your comments and consider them, draft
 

the final rule. That has to be cleared by the
 

Department, and there's various things that have
 

to be done before it can be finalized. So we're
 

on a very tight time frame. We want to get this
 

rule, these rules finalized and so that we can
 

get this program up and running and people paid.
 

DR. ZIEMER: And is it my understanding that
 

the final rule also includes, perhaps as an
 

appendix or something, the public and Board
 

comments, as well as the response of the Agency
 

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to the comments?
 

MS. ARMSTRONG: The Agency will address the
 

comments in the preamble to the rule.
 

DR. ZIEMER: In the preamble, thank you.
 

MS. ARMSTRONG: Right. The comments
 

actually are available now. You can see them on
 

the OCAS —
 

DR. ZIEMER: They're on the web site, yes.
 

MS. ARMSTRONG: — OCAS web site.
 

DR. ZIEMER: Right.
 

MS. ARMSTRONG: But they won't be appended
 

to the final —
 

DR. ZIEMER: But the responses will?
 

MS. ARMSTRONG: Well, but the comments will
 

be addressed in the preamble to the rule-making
 

as to why changes were made or not made.
 

DR. ZIEMER: Are there questions for Mary at
 

this time? Questions on the other legal issues,
 

your conflicts of interest and so on?
 

[No responses]
 

DR. ZIEMER: Okay. Thank you very much,
 

Mary.
 

And if you do have private comments or
 

questions for Mary on any of those legal issues,
 

including your conflict of interest waiver
 

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documents, you can talk to Mary individually on
 

that.
 

Right?
 

MS. ARMSTRONG: I'm actually going to have
 

to leave and go back to HHS, but Alice and Liz
 

will be here.
 

DR. ZIEMER: You have staff people here to
 

help. Thank you.
 

Okay, then I think we will proceed, even
 

though we're a little ahead of schedule. That's
 

fine. And we're going to now hear from Larry
 

Elliott, who, as has already been indicated,
 

serves as Executive Secretary for this Advisory
 

Board, as well as serving as the Director of the
 

Office of Compensation.
 

Larry, please proceed.
 

MR. ELLIOTT: Well, as many of the previous
 

speakers have mentioned, you have several
 

responsibilities and a huge, challenging task
 

before you, and we're going to talk about that
 

now. I'm going to walk you through the
 

responsibilities as they're specified from their
 

genesis in the Act, the Employees Compensation
 

Program Act, as well as the Executive Order and
 

finally your charter.
 

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But let me step back and briefly talk about
 

— we've reopened the public comment period for
 

both rules, the interim final rule for dose
 

reconstruction and the notice of proposed rule-


making for probability of causation. Those were
 

reopened last week in order that this Board and
 

the public can provide comments during this Board
 

meeting, and the Board will be able to provide
 

its consensus comments to the record before
 

February 6th. That's a daunting challenge.
 

We're going to have a lot to do before February
 

6th.
 

Tomorrow, the close of business tomorrow,
 

will end the public comment period, the receipt
 

of public comments for the record. But we'll
 

leave the record open for the Board's
 

deliberations on its consensus comments, which
 

again will need to be submitted by February 6th.
 

That's a goal that we have set, and I'd like to
 

see us achieve that goal. And it's tied in to
 

our need and our intent to finalize and
 

promulgate these rules so that we can use them,
 

and so that the Department of Labor can
 

adjudicate the claims that we have in our hands
 

and those that we understand are forthcoming.
 

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Any questions on our reopening of the public
 

comment period and what that constitutes for this
 

body?
 

UNIDENTIFIED: What were the two areas
 

again?
 

MR. ELLIOTT: The two areas? There's two
 

rules. Is that —
 

UNIDENTIFIED: Yeah, you mentioned public
 

comment for something and something.
 

MR. ELLIOTT: Well, there's two rules.
 

There's an interim final rule on dose
 

reconstruction. That's a rule that NIOSH will
 

use, along with technical guidelines that support
 

that rule, to do individual dose reconstructions
 

on cancer-related claims.
 

And then there's a rule of probability of
 

causation, which is a notice of proposed rule-


making, a slightly different track toward
 

promulgation. And that rule will be used by the
 

Department of Labor to finally adjudicate and
 

come forward with a recommended decision on a
 

cancer-related claim.
 

UNIDENTIFIED: Thank you.
 

DR. ZIEMER: Incidentally, these are Code of
 

Federal Regulations, Part 42 —
 

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MR. ELLIOTT: 42.
 

DR. ZIEMER: — CFR 81 and 82.
 

MR. ELLIOTT: Right.
 

Yes, Dr. Anderson?
 

DR. ANDERSON: Just a quick question on the
 

choice of February 6th. Was this a statutory
 

requirement, that you could only open it for a —
 

MR. ELLIOTT: No, sir.
 

DR. ANDERSON: I mean, it seems that you're
 

putting a great deal of —
 

MR. ELLIOTT: I'm putting pressure on the
 

Board, yes, I am.
 

DR. ANDERSON: You're putting pressure on
 

the Board without having consulted the Board on —
 

we cancelled the last meeting because you weren't
 

able to process paperwork.
 

MR. ELLIOTT: Right.
 

DR. ANDERSON: And now we're left with a
 

two-week period here to — and generally the
 

advice you get is proportional to how much time
 

one has to give to it, so —
 

MR. ELLIOTT: Yes, we understand that. We
 

recognize that. And that's why I'm being very
 

frank with the Board, that this is a challenge
 

and a goal that we — the Department has set in
 

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order to achieve an April promulgation deadline.
 

DR. ZIEMER: And I might comment, Dr.
 

Anderson, I think the Board, by the end of the
 

day tomorrow, will have a better feel for whether
 

that's realistic. I think perhaps the Agency
 

feels that the quality of our advice may be
 

inversely proportional to the time available, so
 

who knows. It's all in the modeling. It's like
 

the dose reconstruction.
 

MR. ELLIOTT: Well, we're going to give you
 

as much help and support to try to achieve this
 

goal as possible. And as I've said to staff from
 

the very start, we're going to do the best we
 

possibly can, and we'll see what we can
 

accomplish.
 

So from the Energy Employees Occupational
 

Illness Compensation Program Act, it was the
 

sense of the Congress — or you can translate that
 

into their understanding, or perhaps their belief
 

— that there were hundreds of thousands of
 

workers who had served the nation in developing
 

the nuclear weapons arsenal, and also that many
 

of those workers have had to pay a high price for
 

that occupational employment in dealing with the
 

special types of exposures that they encountered.
 

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These bullets are all paraphrased from the
 

opening of that Act, and that really is — serves
 

as the backdrop and the background on why we're
 

here today. There was a huge watershed shift in
 

philosophy and culture surrounding DOE and the
 

weapons program that has resulted in a
 

compensation program dedicated to those workers.
 

The purpose of this compensation program is
 

to provide timely, uniform and adequate
 

compensation for covered employees, or their
 

survivors, who have suffered from illnesses
 

incurred in the performance of the Department of
 

Energy work and its contractors and
 

subcontractors, and those entities that were in
 

place before DOE came along that were contracted
 

under the Atomic Energy Commission, called atomic
 

weapons work employers.
 

What this body is specifically concerned
 

with regarding the language of the Act is those
 

claimants who come forward who have cancer. And
 

in this part of the Federal program for this
 

compensation program, an employee at a DOE work
 

site who was a contractor or a DOE employee at
 

that work site and sustained cancer in the
 

performance of duty at that work site will be
 

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awarded compensation if it was determined that
 

the cancer was at least as likely as not related
 

to the radiation exposure in the performance of
 

that duty. What's critical here to understand is
 

that we're only dealing with radiation. We're
 

not dealing with inter — effects from chemicals
 

or interrelated effects from other types of
 

exposures. We're only going to assess radiation
 

exposure and its potential association in
 

relationship with the cancer as an outcome.
 

An individual who's a covered employee must
 

have a specified cancer if they are within a
 

member — a member of the Special Exposure Cohort,
 

and those are 22 cancers that are listed that
 

have been amended recently by acts of Congress.
 

So we're not going to see those individual SEC
 

cancer claims. The Department of Labor will
 

automatically verify their employment through
 

Department of Energy, verify the diagnosis of the
 

cancer, assure that it's one of the 22 that's
 

presumed in that list, and provide an award.
 

This body will see all other types of cancer and
 

all other — for individuals at all other sites,
 

as well as individuals at these Special Exposure
 

Cohort sites who do not have one of those 22
 

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I 

listed cancers.
 

I'm going to move to the Executive Order.
 

didn't cover a lot of territory in the Act. I
 

hope you've had time, chance to read it. There's
 

a lot of other information in the Act about
 

beryllium and silica. We're only going to focus
 

on cancer. But if you have questions about that,
 

we would entertain those and give you a response.
 

So in the Executive Order we get a little
 

bit more specific information about who's going
 

to do what and how they're going to do it. This
 

Order sets out the Agencies' responsibilities
 

across four Departments in the Executive Branch,
 

and those responsibilities are specified to
 

accomplish the program's goals and building on
 

the principles and the framework that was set
 

forth in the Act. The Department of Labor, the
 

Department of Health and Human Services, and the
 

Department of Energy are all responsible for
 

developing and implementing specific actions
 

under the Act to compensate these workers.
 

Here's the specific responsibilities of the
 

Secretary of Labor — and Mr. Hallmark went
 

through these in his presentation, but just as a
 

reminder they have the lead, as the lead Agency,
 

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in administering the program:
 

They determine the eligibility and
 

adjudicate the claims for all the Federal
 

compensation claims that come forward, not only
 

cancer, but the silica and beryllium. They have
 

promulgated their regulations for the
 

administration of the program, which Mr. Hallmark
 

mentioned, back in May, and that's how this
 

program is to function.
 

They are to ensure the availability of all
 

forms necessary to complete a filing of a claim.
 

And if you've been on their web site, you've seen
 

these forms. Their resource centers provide the
 

forms and provide guidance on how these are
 

completed. They are to develop information
 

materials in accordance — in coordination with
 

the Department of Energy and with the Department
 

of Health and Human Services, which are designed
 

to help claimants understand the process and
 

understand their eligibility for this program,
 

and how to file their applications.
 

The Secretary of Health and Human Services
 

have been given these responsibilities under the
 

Act:
 

Specifically, to promulgate the regulations
 

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that we have before us in draft form to establish
 

guidelines for determining the probability of
 

causation and for methods to conduct and complete
 

dose reconstructions on an individual claim
 

basis. We're also in the Department of Health
 

and Human Services responsible for conducting
 

those individual dose reconstructions for a
 

verified cancer claim.
 

We have another responsibility, which is to
 

consider and issue determinations on petitions by
 

classes of employees to be treated as members of
 

the Special Exposure Cohort. This is a distinct
 

and daunting challenge before this committee. We
 

will bring forward at a later meeting of this
 

body the process guidelines, policy guidelines
 

from the Secretary on how he wishes to proceed
 

with this, and seeks your review and guidance on
 

those.
 

We are also in HHS to appoint members to the
 

DOE physicians' panel, which Dr. Rest indicated
 

to you we have accomplished that, and the
 

Department of Energy is finalizing its rule on
 

how those panels will operate and be run. It is
 

simply our role at HHS to provide appointed
 

physicians to serve on those panels. Those
 

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panels review state-based compensation claims.
 

They don't do anything or have any auspice over
 

the Federal side of the program.
 

And finally, HHS is responsible for staffing
 

and administrative support to this Advisory
 

Board.
 

The Secretary of Energy has a number of
 

responsibilities, which take two slides rather
 

than the one for Labor and HHS:
 

Energy is to provide HHS and this advisory
 

body, in accordance with law, assistance and
 

access to all relevant information that we need
 

to do dose reconstructions, that we need to
 

evaluate worker exposures, and understand how we
 

should handle petitions for additions to the
 

Special Exposure Cohort.
 

And as permitted by law, upon request from
 

the Department of Labor or the Department of
 

Health and Human Services, DOE is to require
 

their contractors and subcontractors and
 

designated beryllium vendors to provide
 

information that would be relevant to a given
 

claim.
 

DOE is also to identify and notify
 

potentially eligible individuals of the
 

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compensation program, and they're doing that
 

through their outreach program jointly with
 

Department of Labor.
 

The Secretary of Energy also has a
 

responsibility to designate atomic weapons
 

employers and provide additions to the list of
 

designated beryllium vendors. If you've been on
 

our site and gone to the related links and looked
 

at DOE's site, you'll see the list. I think I
 

shared that with you when we were talking about
 

where we might want to meet in the future.
 

That's a relevant list of all covered facilities
 

around the country, and this is a responsibility
 

that Energy has to augment that list and make it
 

correct and as complete as possible.
 

They are at Energy to negotiated agreements
 

with states to provide assistance to the
 

Department of Energy contractor employees filing
 

state Worker's Comp claims, and I know that
 

they're still engaged in establishing those
 

agreements with the states.
 

They at Energy are also to provide annual
 

reports on the Worker Assistance Program
 

regarding the claims-related statistics that are
 

generated, both on the Federal side and the state
 

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program side.
 

And they are to publish in the Federal
 

Register a list of atomic weapons employer
 

facilities that I mentioned earlier, and that has
 

appeared and been updated.
 

The Attorney General in the Department of
 

Justice has some specific responsibilities, as
 

well, as specified in the Act.
 

These include developing procedures to
 

notify each claimant of their approval of a
 

Radiation Exposure Compensation Act claim — the
 

RECA program — by the Department of Justice, and
 

the availability of supplemental awards under
 

this Energy Employees Occupation Illness
 

Compensation Program.
 

The Attorney General is also to identify and
 

notify eligible uranium workers or their
 

survivors about the availability of this
 

supplement, and they're also to provide
 

information upon request from the Department of
 

Labor needed to adjudicate claims of a covered
 

uranium employee under this new program.
 

The Executive Order also provides some more
 

specifics, in detailed outline here, for what
 

this Advisory Board is charged with and what your
 

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responsibilities are.
 

As we noted, you're appointed by the
 

President. There's been a delegation of
 

authority to HHS to staff this Board and provide
 

administrative support to the Board. And you're
 

charged with providing advice to the Secretary
 

and also to our regulatory docket on the
 

guidelines for determining the probability of
 

causation.
 

That's the first thing we're going to take
 

up, is that rule. And when we look at that rule
 

and you start thinking about what you want to
 

comment on or what you want to discuss, I would
 

enjoin you to look at the early part of that
 

rule, and there are three questions that we asked
 

everybody in the public to comment on. The
 

Secretary would like you to focus on those three
 

questions and center your comments on that. The
 

Secretary would like you to identify any other
 

questions you want to advise on, but we really
 

would seek your input and advice, counsel on
 

those three questions. And I can go over those
 

in a moment when I get back to my seat.
 

Also, you are to evaluate and review the
 

scientific validity and the quality of dose
 

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reconstructions. And we're going to have to
 

discuss how we're going to go about that.
 

Tomorrow we have an agenda item on the work of
 

the Board and how we're going to schedule this
 

work, how you want to arrange the work of this
 

Board.
 

This is a huge task, an ongoing task, where
 

you'll be engaged in reviewing dose
 

reconstructions. And I'm sure that you're not
 

going to find yourselves wanting to sit down and
 

look at thousands of dose reconstructions that
 

we're going to have to do, so we're going to have
 

to talk about a sampling strategy and an approach
 

that makes sense and is representative and
 

reasonable.
 

And finally, the Board has a responsibility
 

to advise the Secretary on how to handle, how to
 

decide on petitions for the Special Exposure
 

Cohort. And so we need to discuss that as a
 

process for this Board, and how your advice will
 

be engendered to the Secretary.
 

Let me talk a little bit about the structure
 

of the Board. The charter indicates that the
 

Board will consist of no more than 20 public
 

members appointed by the President, so the
 

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President still has an option here to fill ten
 

more seats, or he can leave this at ten.
 

The members shall include affected workers
 

and their representatives, and representatives
 

from the scientific and medical communities.
 

This is the balance that was attempted to be
 

achieved by the appointments.
 

The Chair is also designated by the
 

President, and it's an option for this Board to
 

establish subcommittees or working groups to
 

facilitate the work of the Board. And that's
 

something we need to talk about with regard to
 

this dose reconstruction review process.
 

Frequencies of the meetings shall be based
 

upon the Agency needs as determined by HHS, CDC,
 

and NIOSH. And as a Designated Federal Official,
 

I assure you I am working very closely with your
 

Chair, Dr. Ziemer, to establish the agenda.
 

Looks like we need to regroup on how much time we
 

allot, but we're — it's good to be ahead of the
 

agenda rather than behind the agenda. So we're
 

learning from that.
 

A government official will have to be
 

present at all meetings, and we can hold meetings
 

over the telephone. We might choose to do that,
 

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where we will have a public meeting by phone to
 

conduct business of the Board. If we prepare
 

consensus comments and need to vote on those with
 

minimal discussion, we might be able to do that
 

before February 6th in order to accomplish that
 

task.
 

So I'm trying to give you a little bit of
 

insight. Do I expect you to finish all of this
 

up before close of business tomorrow? No. Do I
 

expect you to try to get consensus comments on
 

the probability of causation rule by February
 

6th? Yes. How do we do that? We're going to
 

use the rest of today and tomorrow to try to
 

achieve that, and if we need to have a public
 

telephone call to finalize those comments we will
 

do so.
 

All meetings shall be open to the public,
 

and public notice will be given of all meetings.
 

So if we decide that we need to have a telephone
 

conference call to finalize some business we will
 

announce that, and we'll announce it as soon as
 

possible. When we talk about the work and the
 

schedule of work for the Board tomorrow, we'll
 

need to take this into consideration in order for
 

Cori to make the announcement publicly, that we
 

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would have a meeting before our next scheduled
 

meeting February 13th, the 12th and 13th.
 

All records of the proceedings shall be kept
 

as required by the laws and the Department
 

regulations, and they're available to the public,
 

available, of course, to each individual Board
 

member. As we noted, this Board is in a paid
 

status as a Special Government Employee.
 

Earlier in Helen's talk and in the film you
 

saw that there's an annual report that has to be
 

prepared. That's my responsibility, and I want
 

you to realize what I'm going to be reporting on
 

in that report: How well we do in achieving our
 

goals and moving forward in our work.
 

We will provide a list of all members, and
 

we'll talk about their backgrounds and what
 

perspectives they bring in that report. We talk
 

about the functions and the dates of the meetings
 

and the places of the meetings, and the purpose
 

behind each meeting. And we also in that report
 

present any recommendations, consensus comments
 

or advice that's been generated from those
 

meetings during a fiscal year.
 

So each fiscal year we will prepare a report
 

containing this information. This report is
 

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advanced to the Office of Committee Management,
 

and it eventually makes its way up through and to
 

the Congress through the President's office.
 

Unless renewed by appropriate action prior
 

to the expiration date, which this charter has
 

two years, this committee will terminate in two
 

years. But I anticipate that that will be
 

renewed, given the workload that we have.
 

And that's all I have to present to you.
 

Are there any questions about the tasks, the
 

responsibilities, the challenges that we have?
 

We're starting to get into the meat of our work
 

here, so it would be good if you have any doubts
 

or thoughts that you want to — need clarification
 

on.
 

[No responses]
 

DR. ZIEMER: I see no Board members rising
 

to that challenge to ask a question. I know that
 

the Board has had copies of the charter and
 

related documents for some period of time, and
 

has had an opportunity to study them.
 

Thank you very much, Larry.
 

I'm going to pause at this point for some
 

housekeeping item or items, and then we'll return
 

to the agenda. First of all, for lunch today you
 

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will be on your own. And I believe Cori may have
 

prepared a list of nearby restaurants or eating
 

establishments and other fast food places,
 

whichever your preference is.
 

Cori, do we have that available?
 

MS. HOMER: We do.
 

DR. ZIEMER: Let's go ahead and distribute
 

that at this point.
 

I also would mention to the Board that you
 

are basically on your own for dinner this
 

evening. There is no Board dinner planned.
 

We're not going to have a working lunch or dinner
 

today, so you're pretty much on your own,
 

whatever arrangements you make.
 

Now let's return to the agenda. I want to
 

follow up on Larry Elliott's comments.
 

First of all, Larry, perhaps it would be
 

good if you amplified what the three questions
 

are that have been asked of the independent
 

reviewers, and which are being asked of this
 

Board to consider. Could you direct us to those
 

three questions?
 

MR. ELLIOTT: Yes.
 

If you would turn to your tab that has the
 

probability of causation rule presented. On that
 

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first page under Roman numeral I, Comments
 

Invited, you'll find three questions.
 

The first: Does the proposal make
 

appropriate use of current science and medicine
 

for evaluating and quantifying cancer risks for
 

DOE workers exposed to ionizing radiation in the
 

performance of duty?
 

The second: Does the proposal appropriately
 

adapt compensation policy as it has been applied
 

for the compensation of veterans with radiation
 

exposure from atomic bombs to compensation policy
 

for radiation-exposed nuclear weapons production
 

workers?
 

And the third: Does the proposal
 

appropriately and adequately address the need to
 

ensure procedures under this rule remain current
 

with advances in radiation research — health
 

research?
 

Likewise, under your tab on dose
 

reconstruction and that rule, on that same first
 

page under Comments Invited, you'll find three
 

additional questions pertinent to that rule on
 

dose reconstruction. And I won't — I guess —
 

should I read those for the record?
 

DR. ZIEMER: No.
 

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MR. ELLIOTT: Okay.
 

DR. ZIEMER: They're similar questions.
 

MR. ELLIOTT: They're similar questions.
 

Any question from the Board about these
 

questions, and certainly any other questions you
 

want to add? But we're just trying to focus your
 

discussion and deliberation in this regard.
 

[No responses]
 

DR. ZIEMER: If not, then I would like to
 

prepare the Board for our discussion that will
 

occur after lunch.
 

We're going to have a discussion on Board
 

responsibilities, and I want to provide you with
 

some items to think about. You can start
 

thinking over lunch on these items, and then be
 

prepared to discuss them.
 

Because one of the things that we have to do
 

as a Board as we make recommendations is to reach
 

what is called consensus. And there may be some
 

question about what consensus means for a group
 

like this. And in fact, one of the jobs that we
 

have is to determine how it is we are going to
 

operate as a Board. How is it we are going to
 

reach consensus, and what does it mean to reach
 

consensus?
 

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So let me throw out some ideas for you to be
 

thinking about, and then we can talk about how we
 

can formalize these ideas, if that is — I don't
 

have the answers, but I want to stimulate your
 

thinking on some approaches that might be used,
 

and then we can finalize those later in the day.
 

First of all, a lot of how this committee
 

operates has already been defined in the public
 

law, so we don't have to deal with how our
 

membership is selected and how often we meet, and
 

the keeping of records and so on. That's already
 

defined in the law, and is in a sense beyond our
 

scope.
 

We do have some degree of flexibility,
 

however, in determining how we are going to
 

operate in terms of defining issues and coming to
 

consensus on questions or items that we want to
 

recommend to the Secretary of Health and Human
 

Services. So let me start — and I'll sort of
 

break these down into categories of items to
 

think about.
 

First of all, what constitutes a quorum?
 

Now I am proposing that we will normally operate
 

under Robert's Rules. Now Robert's Rules are
 

designed to do two things. One is to allow the
 

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majority to reach its conclusion, but also to
 

allow the minority to be heard. On any question
 

there are typically two and sometimes more views,
 

so Robert's Rules are really designed so that
 

those with what you might call minority views
 

have a chance to voice their views and those
 

views be taken into consideration, but that
 

ultimately the minority does not control the
 

final decision; that the majority can rule. And
 

there are a variety of ways that this is done.
 

In Robert's — under Robert's Rules,
 

particularly if you have large groups — say, 100,
 

like you would have in the Senate, or many more
 

in some larger assemblies — Robert's Rules sort
 

of help you keep order and make sure that those
 

who have views are allowed to air them. And so
 

there's a large degree of formality that is
 

carried out when you use Robert's Rules in a
 

large assembly.
 

In a small assembly such as this, a ten-


member committee, Robert's Rules can be used a
 

little more informally. For example, if it's
 

clear through discussion on some minor point that
 

we're in agreement, the Chair can simply declare
 

that there's agreement on this, and let's do it.
 

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Now I'm not talking about necessarily the formal
 

recommendations to the Secretary of Health and
 

Human Services, but on issues where we might have
 

some debate on what we should do next. On the
 

other hand, we do have to have some definitions
 

on how we go about determining, when we make the
 

formal recommendations, what it takes to do that.
 

Now on the issue of quorum, that is normally
 

well-defined. In Robert's Rules it's not
 

necessarily defined. Robert's Rules allows bylaws, for example, to define what a quorum is.
 

In fact, I was at one time involved in a group
 

that defined a quorum as those present, as long
 

as it included one of the officers of the
 

organization. Well, that sort of covers anybody
 

that shows up, I guess. But typically a quorum
 

is more than half the members. In our case that
 

would be six.
 

I'm unsure myself as to whether the FACA
 

rules require that to be the quorum, but unless I
 

learn otherwise, I think we can —
 

MS. HOMER: Generally it's one more than
 

one-half.
 

DR. ZIEMER: One more than one-half. By my
 

advanced math, that's close to six.
 

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UNIDENTIFIED: Let's discuss it.
 

DR. ZIEMER: Yeah, let's discuss it. So I
 

think we can assume that a quorum is six. Now
 

that would mean that we could have a meeting and
 

could do business with six people.
 

Now this leads to the next issue, and that
 

is what then constitutes consensus? Now it's one
 

thing if all ten members are present and you say,
 

well, we need a majority or we need two-thirds or
 

some percentage. But if you have just a quorum —
 

six people, for example — a majority of six is
 

four, but that's not half of the committee. So
 

you have those kinds of issues.
 

So what I would like us to think about, for
 

example, would be if we do talk about consensus,
 

that we consider, for example, that consensus is
 

at least 50 percent of the membership. That
 

would be also six, six positive votes on
 

something.
 

Now under Robert's Rules, the Chair does not
 

normally vote. In fact, under Robert's Rules the
 

Chair votes when there is a tie. When there are
 

ten members, nine of whom are voting, you never
 

have a tie, which means the Chairman would never
 

vote. Well, the Chairman sort of objects to
 

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that. In fact, under Robert's Rules, if you went
 

with a majority of those voting, you would have
 

five as the pass point. Is that consensus?
 

So one thing I would like us to think about
 

is should we in fact specify that in cases where
 

there are, for example, five/four votes, that we
 

mandate that the Chairman vote. Now that can
 

still drive it to a real tie, which means you
 

don't have consensus. Or it can tip to a six/four
 

vote.
 

So I'm not suggesting we answer that
 

question now. I want you to think about it, but
 

I want to talk about it when we return from lunch
 

so we can sort of codify how we will achieve
 

consensus. We could also say that
 

consensus is something else. Is it
 

two-thirds rather than one-half, in
 

which case it would be seven votes
 

rather than six?
 

Now likewise, if we don't have full
 

membership present, is consensus a majority of
 

those present and voting, or is it a fixed
 

number? For example, is it always, say, six?
 

That is, if you have only six present, do they
 

all have to agree on something for it to be
 

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consensus? So think about that, as well. And in
 

fact, I think for us the issue of what
 

constitutes consensus is one of the key things we
 

need to establish for our working rules.
 

Next, subcommittees and working groups. As
 

I understand it, we are allowed to have
 

subcommittees and working groups.
 

Subcommittees would simply be subsets of
 

this group here. The Chairman could, for example
 

— and normally it's the Chairman's prerogative to
 

appoint such subcommittees; always done, of
 

course, with the input of the full committee.
 

But for example, if we say we need a subcommittee
 

to work on answering this particular question —
 

for example, one of the three questions that was
 

posed — to draft a response for the full
 

committee to review, then we could say, okay,
 

let's ask these three or four people to be that
 

subcommittee. And I think that's the Chair's
 

prerogative, and we certainly will do that as
 

needed.
 

With respect to working groups, it's my
 

understanding that the Board can in fact have
 

working groups that might include even outside
 

experts. Although there's a breadth of expertise
 

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on this committee, there are some issues where we
 

might want additional expertise, and it may be
 

that we would have to consider establishing some
 

sort of working group to address some particular
 

issue that the committee perhaps feels
 

uncomfortable or wants more detail on. I don't
 

have anything particular in mind, but that is
 

something that, as I understand it, could be
 

done.
 

MR. ELLIOTT: Yes.
 

DR. ZIEMER: And then the other thing is
 

that I want to mention that at all of our
 

meetings, including today's and tomorrow's
 

session of this meeting, we will have a time for
 

public input. Generally, as we proceed, that's
 

intended for members of the public or particular
 

groups to give their views on any of the issues
 

that are before us.
 

It is not my intent that those become
 

sessions where we debate with people what their
 

views are, but rather hear their views and take
 

them into consideration as we deliberate.
 

Whether or not you individually agree with any
 

particular person's view, I certainly think it's
 

appropriate if you have questions to ask of
 

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members of the public to clarify something that
 

they present, but it's not, certainly has not
 

been my intention, that we use that time to
 

debate them on their views or try to change
 

somebody's views.
 

So those public sessions are simply times
 

where we hear what other people's views are on
 

some of these issues, and give them a chance to
 

comment either on how we are proceeding or
 

comment on the rules or concerns that they may
 

have.
 

Now let me ask for any immediate responses.
 

Again, I just want to sort of get a feel or
 

feedback as to where some of you are on these
 

issues. If there's items that you think that —
 

and I've simply thought about some of these, and
 

I raise them now to make sure you're thinking
 

about them.
 

But are there some other issues that you may
 

have thought about as to how we proceed?
 

And again, some of the timing issues — Dr.
 

Anderson raised the issue of do we have enough
 

time. I don't think we know right now the answer
 

to that. But certainly this Board has a fair
 

amount of latitude, and can decide when and where
 

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they're going to do something. But I think we
 

also want to be responsive to the needs.
 

I'm an academician who likes to take years
 

and years to study things, but there is a sense
 

in which this is upon us. We're not going to
 

have all the answers to all the scientific
 

questions. We clearly will not. And so we have
 

to make decisions with what's available.
 

I open the floor for comments. Yes.
 

DR. DeHART: Roy DeHart.
 

We are not an expert committee. We're an
 

advisory committee, which burdens us with a
 

greater task than most similar committees would
 

have. As an advisory committee, we sit around
 

this table bringing our own individual expertise,
 

whether it's health physics, epidemiology,
 

medicine or whatever, to the table. But there
 

are voids, major educational and scientific
 

voids, when we start dealing with these subjects.
 

And I think that has to be a reality and
 

considered. It is with me. And even though
 

there are time constraints and limitations, I
 

don't know how quickly we can fill the void, or
 

whether I just accept the consensus of the table
 

and go with that. And I'm going to have to work
 

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on that as we go through.
 

DR. ZIEMER: Thank you.
 

MR. ELLIOTT: If I could, certainly the
 

NIOSH technical staff are here to help answer
 

questions, help explore areas that you may not be
 

comfortable with or have experience with or
 

education in. And if there are other external
 

experts that the Board wants us to bring in, we
 

can certainly accommodate that.
 

DR. ZIEMER: Okay, there's a lot of
 

pondering going on.
 

UNIDENTIFIED: Yeah, there is.
 

MR. PRESLEY: Sir, Bob Presley.
 

DR. ZIEMER: Yeah, Bob.
 

MR. PRESLEY: Under the quorum and what
 

constitutes consensus, there's going to be times
 

that some of us are going to have to excuse
 

ourselves. I think we need to look at that.
 

DR. ZIEMER: Thank you, that's a good point.
 

What do we do if there are abstentions? In other
 

words, in some cases that may be due to conflicts
 

of interest. I know on my sheet there are
 

certain items that I'm precluded from voting on.
 

So whatever we decide in how to proceed, we'll —
 

and I hadn't thought of that — we'll need to
 

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include what do we do in those cases.
 

Thank you, good point.
 

Others? Yes.
 

DR. DeHART: In fact, it might be wise
 

someplace during the day to find out what areas
 

we have to exclude ourselves. We may find that
 

there are three or four of us that are going to
 

be out at the same time.
 

DR. ZIEMER: Right. Right. A chance for
 

the others to really exercise their power, right?
 

Okay, thank you.
 

Other comments?
 

[No responses]
 

DR. ZIEMER: Thank you. If that — if there
 

are no more comments, I think we will extend the
 

lunch hour a little bit since not everybody's
 

familiar with the locations, maybe give you a
 

little more time to take your lunch. You may
 

have to go off site anyway. I don't know if the
 

place here will accommodate everybody at once
 

anyway. So that'll give us a little more time.
 

Plan to be back here at 1:00 o'clock, and we will
 

continue. So we're in recess till 1:00 o'clock.
 

[Whereupon, a lunch recess was
 

taken from approximately 11:22 a.m.
 

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until 1:05 p.m.]
 

DR. ZIEMER: Thank you. We'll now
 

reconvene.
 

I trust you all had a suitable break and
 

lunch period. We have some folks who've joined
 

us since the lunch period, and I should tell
 

those who've joined us, particularly observers,
 

that earlier today we had everybody introduce and
 

say who they were and who they were representing.
 

And I know we have at least one and maybe more
 

people who now have joined us after lunch.
 

So I'm going to start over here with Joe
 

Fitzgerald, and Joe, if you'll stand and tell us
 

who you are, and then we'll see if anyone else —
 

MR. FITZGERALD: I'm Joe Fitzgerald, I'm
 

with SAIC.
 

DR. ZIEMER: Thank you.
 

And who else has joined us since — in the
 

back, please.
 

MR. SILVERMAN: I'm Josh Silverman. I'm
 

with the Department of Energy's Office of
 

Environment, Safety and Health.
 

DR. ZIEMER: Thank you, Josh.
 

Any others?
 

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[No responses]
 

DR. ZIEMER: Very good.
 

One announcement that's a repeat. If you do
 

wish to make any public statements at the
 

appropriate time later today, we ask again that
 

you sign up in the foyer. There's a sign-up
 

sheet, again simply for purposes of allotting
 

time fairly amongst those who wish to speak.
 

I remind you again that — this is for the
 

Board, others as well — but you're on your own
 

for dinner this evening.
 

Let me ask Cori if there's any other
 

housekeeping items we need to address right now.
 

MS. HOMER: Not at the moment.
 

DR. ZIEMER: Okay, not so far as we know.
 

Thank you.
 

We're going to deal with the issue of Board
 

procedures in just a moment, but before we do
 

that I'm going to ask Larry — Larry, if you could
 

give us very briefly the information, the general
 

information about waiver issues. I think it — we
 

talked earlier this morning about having people
 

tell their waiver areas. I don't see any need
 

that we do that right now. We're not going to be
 

dealing with site-specific stuff certainly today
 

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or even the next meeting, but perhaps some
 

general information about the conditions under
 

which committee members are required to sign
 

waivers. And Larry, if you could provide that
 

information, then we'll proceed from there.
 

MR. ELLIOTT: Certainly.
 

Not every member of this Board received a
 

waiver letter this morning. There were, I
 

believe, eight individuals who did — seven
 

individuals who did. And it's expected that the
 

Board will focus largely on matters of general
 

applicability, as opposed to matters involving
 

specific parties or matters that uniquely and
 

distinctly affect any particular person or
 

organization.
 

And so that's the background of the general
 

applicability of the waivers that were granted.
 

That means that this Board is going to take on
 

discussion and deliberation on matters that have
 

wide-ranging and general applicability, the
 

probability of causation rule and the dose
 

reconstruction rule.
 

The waivers do go further to provide
 

specific individual guidance to each member who
 

received a waiver regarding matters that would
 

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come under discussion that are more specific in
 

nature to their particular personal experience or
 

financial involvement. And so when we come to
 

the point of discussing reviews of individual
 

dose reconstructions at a given site or reviews
 

and advice to the Secretary on Special Exposure
 

Cohort petitions, that's when an individual Board
 

member might feel they need to recuse themselves.
 

And so I think — I hope that is adequate
 

background information on these. And they are —
 

of course, the waivers are available under the
 

Freedom of Information Act, and I'm sure that —
 

and I know that we will have a such request, if
 

we don't already have it in our hands. And we
 

will respond to that request by providing a copy
 

of the waivers that have been signed. And those
 

are not available today, but they will be
 

available as we get back into the offices and get
 

these on file and make all appropriate notations
 

to them.
 

DR. ZIEMER: Thank you.
 

We want to proceed now with the agenda item
 

that's called Board Responsibilities and
 

Operating Procedures. You recall that we had
 

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some preliminary discussion before lunch at least
 

to stimulate your thinking on some of the issues
 

that we need to consider as we more or less
 

codify the procedures that we will use to develop
 

recommendations to the Secretary of Health and
 

Human Services.
 

What I propose that we do at this point is
 

get individual feedback from the Board members on
 

your views on the issues that I raised before
 

lunch. I'm not proposing that we draft something
 

here as we sit at the table, but try to get some
 

idea of what the views of the members are on the
 

issues that were raised.
 

And then we will draft a — probably this
 

evening, and the Chair will ask for some
 

volunteers to help draft that — but we will get a
 

straw man draft that we can use tomorrow. I
 

don't think we'll be at a point today where we
 

need to be voting on any issues. Today is still
 

an informational day. So we really have into the
 

day tomorrow to finalize how we proceed.
 

So again, particularly what we want to be
 

talking about is the voting procedures, as to how
 

we come to what we were calling consensus. And I
 

know there's some debate about the meaning of the
 

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word consensus itself. I understand, and I've
 

asked that we even get a dictionary definition of
 

that. Preliminary indication is that even the
 

dictionary's a little vague. It does not — in
 

the dictionary is not defined as unanimity, but
 

we'll actually get the formal definition of that.
 

But the issue really is how we agree to develop
 

recommendations that we take forward to the
 

Secretary.
 

So I would be glad just to open it up if you
 

have individual views on any of those issues that
 

we raised on how we vote, what constitutes —
 

well, what do we do if we have less than the full
 

committee here, those kinds of issues. Have you
 

had a chance to think about that, or was the food
 

so distracting that you didn't think about it at
 

all? Okay, let's start with Wanda, and —
 

MS. MUNN: The food was not that
 

distracting. You know, when you first posed
 

these questions it was fairly clear in my mind
 

what I thought should be done, and then someone
 

threw a curve at us when we started thinking
 

about those of us who had to recuse ourselves and
 

how many of us there might be.
 

That issue notwithstanding, my personal
 

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feeling is that in a board of ten individuals, a
 

quorum really and truly should be more than just
 

one over five. I would prefer to call a quorum
 

seven people in order to be able to do business.
 

I think that's reasonable, given the small number
 

that we have, the intensity of the work that
 

we're going to have to be doing, and the kinds of
 

decisions we're going to be making.
 

Having said that, consensus in a group that
 

size or in the full committee, from my point of
 

view, would be certainly — a number of six would
 

be to me acceptable and probably reasonable,
 

especially given the fact that I've suggested a
 

quorum be seven.
 

DR. ZIEMER: Thank you, Wanda.
 

I might ask the staff, and perhaps Mary or
 

someone else can — Mary Armstrong can tell us if
 

the FACA act defines quorum, if that's already —
 

yes?
 

MS. KUYKENDALL: Actually —
 

MS. NEWSOM: Could you use the microphone,
 

please?
 

MS. KUYKENDALL: Yes.
 

DR. ZIEMER: If it is defined, then we'll
 

have to use what the definition is in the Act.
 

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Otherwise —
 

MS. KUYKENDALL: Quorum is not defined in
 

the Act, but it is addressed in Department — in
 

the Department manual. And quorum, according to
 

the manual, is one-half plus one of the committee
 

membership.
 

Consensus neither is defined in FACA, but in
 

the GSA regulations it states that — it refers to
 

a common viewpoint. But consensus can sometimes
 

be a little problematic, and it is okay to have
 

opposing viewpoints or minority viewpoints
 

because certainly sometimes you want those. So
 

it is good that you all are having this
 

discussion and deciding early on what your
 

consensus vote is going to be.
 

DR. ZIEMER: Okay, thank you.
 

Others? Yes.
 

DR. MELIUS: Two points. One is that no
 

matter what we define as a quorum, I would hope
 

that the people in setting up the meetings would
 

make every attempt to make as many people as
 

possible available for the meetings, that we not
 

try to just go to six or seven, whatever it is.
 

And probably as important as that is that in
 

all our deliberations and major recommendations
 

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that we involve all the committee members in
 

those — in that process, so even if someone can't
 

make it to a committee meeting that we — we may
 

want to defer a formal vote or recommendation
 

until the Chair's had a chance to communicate
 

with that person or persons and get their
 

viewpoint, or defer to the next meeting possibly
 

on some decisions where we really should try to
 

reflect everybody's input into the decision, give
 

them the opportunity to participate.
 

Secondly, on the issue of consensus, I guess
 

I'm particular thinking of this extremely tight
 

time frame we've been given by Larry and others
 

here in terms of the regulations, and that
 

however we define consensus that we make sure
 

that our — whatever report or however we
 

communicate that should reflect everybody's
 

viewpoint, so if there's different viewpoints or
 

a minority viewpoint or whatever that that be
 

included.
 

And I would particularly see with this time
 

frame we have that maybe what our communication
 

is is a collection of our comments or our
 

reflections on the major issues with these —
 

scientific issues with these regulations, that if
 

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we really try to achieve a consensus document
 

that we would all agree on and vote on, that —
 

I'm not sure that's even going to be really
 

possible in the extremely short time frame. So —
 

whereas I can see other issues where we have a
 

longer time frame, that we would try to spend a
 

longer amount of time and reach closer to a
 

consensus in terms of what the — how the
 

recommendation should read.
 

But I just think that the time frame is
 

going to really dictate a lot of what we'll be
 

able to do.
 

DR. ZIEMER: Thank you, Jim.
 

Yeah, Roy.
 

DR. DeHART: Paul, you had in the earlier
 

statements raised the question of your voting.
 

As I mentioned earlier, this isn't a technical
 

panel; it's an advisory panel. And we all bring
 

different experience, different education,
 

different viewpoints, perhaps. I think you are
 

critical. Every one of the ten should be voting
 

if a vote is what's required.
 

On consensus, I'd just remind you that in
 

many situations consensus does not require a
 

vote.
 

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DR. ZIEMER: Yes. Thank you, Roy. I always
 

appreciate people feeling that I'm really needed.
 

Other comments? Yes.
 

DR. ANDERSON: Just following up on what Roy
 

said, I think again issuing advice, it's
 

important to get all the advice that's out there,
 

as I wouldn’t want to have a viewpoint, since ten
 

is relatively small, in a very controversial
 

area. In some instances the one person, if you
 

leave one person out, that might be the most
 

knowledgeable person who's going against the
 

others who may not know as much.
 

So I think it's important for us to identify
 

when we are unanimous on something, and I think
 

that's fairly understandable, and we wouldn't
 

spend much time on issues that we all say that
 

that looks just fine. I think then it depends on
 

what the issue is, how close to that we want to
 

get.
 

I think — I have somewhat of a problem
 

calling a consensus a simple majority. I would
 

rather use the term “the majority” or whatever it
 

is, and just move on from there. And I think it
 

then depends on — if we're into word-smithing, we
 

may then want to go for — we'd have something in
 

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between the simple majority and a unanimity. If
 

we want to call that something else, whether it's
 

seven or eight, I think that might be another
 

level of significance to the Agencies if eight
 

out of the ten people felt this is the best we
 

can do. That certainly is a very significant
 

level, and I wouldn't be overly concerned about
 

not reaching unanimity.
 

So I think it is important to get all the
 

viewpoints out so people can see that, and I do
 

think it's important for the Chair to be part of
 

the voting.
 

It's hard to know what we're going to call
 

what, since we really haven't seen anything that
 

we're going to vote on yet. So I think that — I
 

think we can have some general terminology, that
 

if we're going to take a position it ought to be
 

the lowest level of a position would be simple
 

majority; and in this case, if there's ten of us
 

voting, that would have to be six. So then you'd
 

have the far — the other side would be unanimous;
 

and then maybe something in between, which would
 

be a seven or eight.
 

DR. ZIEMER: Thank you.
 

Other comments? Gen.
 

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DR. ROESSLER: Consensus is a word that to
 

me, whether it's in the dictionary or not, really
 

implies we're all agreeing. And I think maybe
 

that's what the public perception is, or maybe
 

our colleagues' perception is.
 

So I would recommend if we can get rid of
 

that word, if we're not bound by our charter,
 

just to get rid of that word and use the words
 

that have been suggested here. And I like Jim's
 

approach, is that whatever word we use, we make
 

sure that every Board member's vote or comments
 

are a part of it.
 

DR. ZIEMER: Okay, thanks.
 

Other comments? Yes, Roy.
 

DR. DeHART: Not to dig this hole any
 

deeper, but there is one other alternative to
 

voting — abstention. And I could see a situation
 

dealing with a technical question that I'd simply
 

have to abstain from because I don't know. I
 

have no opinion.
 

DR. ZIEMER: Yes, Tony.
 

DR. ANDRADE: Paul, I think that trying to
 

put all these ideas together, I've kind of — it
 

falls into line with what I thought about over
 

the lunch break.
 

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There are going to be some of us that are
 

not able to render an opinion on some issues
 

because of the very reasons that Dr. DeHart
 

brought up. There are going to be cases in which
 

one is not ready, willing and able, simply
 

because of perhaps conflict of interest
 

situations, to render an opinion on a certain
 

situation.
 

When there is unanimity I think it'll be
 

obvious, and I think we're already in agreement
 

about that, okay. However, I think we should go
 

ahead and stick with just the simple definition
 

of quorum, and those people who are ready,
 

willing and able to put forth a decision or to
 

make a decision, and those who — well, can do
 

that. Then we should require a majority vote on
 

any issue, because it is those consensus
 

positions that are our most important product
 

back to HHS through NIOSH, and those things that
 

are going to be recognized.
 

So I really believe strongly that it should
 

be a majority. And even if all members are
 

present, okay, that majority does not necessarily
 

have to be a majority of those who are here. It
 

is simply a majority of those who have not
 

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abstained. And I think if we go along with
 

something that has that as a bases, we'll be able
 

to move forward from here.
 

DR. ZIEMER: For clarification, Tony, you're
 

arguing for majority of those present and voting?
 

DR. ANDRADE: And voting.
 

DR. ZIEMER: And voting.
 

DR. ANDRADE: Right.
 

DR. ZIEMER: As long as there's a quorum.
 

DR. ANDRADE: Yes.
 

DR. ZIEMER: Okay. So in some cases, if the
 

quorum is six and — I'm hypothetical here —
 

DR. ANDRADE: Sure.
 

DR. ZIEMER: — and one of those abstains,
 

you've got five voting, three would carry the
 

day.
 

DR. ANDRADE: Three would carry the day.
 

DR. ZIEMER: Okay.
 

DR. MELIUS: Well, what if five abstain?
 

DR. ZIEMER: That's one view —
 

DR. MELIUS: What if five abstain? I just
 

don't —
 

DR. ZIEMER: No — well, obviously we can get
 

all sorts of extremes.
 

DR. MELIUS: Yeah.
 

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DR. ZIEMER: Right now I think we're simply
 

getting some viewpoints that we can write
 

together into a formal —
 

DR. ANDRADE: If I might follow onto that,
 

this would also serve to put more pressure on the
 

administrative end of this body, in that whatever
 

we're going to be discussing that we should be
 

quite specific about what we want to accomplish
 

in future meetings, in the agenda, so that not
 

only the people that need to be there and have a
 

strong opinion about that will be there, or can
 

at least make a bigger effort to be there, but
 

the public as well will also be informed about
 

the specific issues that are going to be
 

discussed.
 

DR. ZIEMER: Very good.
 

DR. ANDERSON: I would just say that I think
 

we can, depending on what the issue is, it's very
 

easy electronically to go out and the day after
 

get everybody involved. So I would try to avoid
 

the issue of a critical position really being
 

only taken based on three out of ten. I mean,
 

whatever we call it, the Agency's going to look
 

at, well, it went three out of ten. It's not
 

going to carry as much weight.
 

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I 

So I would think we ought to set up a
 

system, either we're going to have an electronic
 

mechanism, or since it's a FACA we probably have
 

to have it public, so we do a teleconference.
 

would think we ought to, just as part of the
 

process here, set up a teleconference for one
 

hour two days after the meeting in case there is
 

something that needs follow-up. If — you can
 

always cancel a call like that, but putting aside
 

an hour two or three days later would be a
 

process I think we probably could do. That would
 

be announced in the Federal Register so you could
 

meet your time lines.
 

And I would ask staff to maybe look at that,
 

and that would be a way that you could get
 

whatever the issue was out to people if it came
 

up, wasn't on the agenda but a vote was taken.
 

Then you'd still have that time for the others to
 

get up to speed. So I think we could —
 

DR. ZIEMER: Agreed.
 

DR. ANDERSON: — we could work around
 

people's schedules.
 

DR. ZIEMER: Tony.
 

DR. ANDRADE: Agreed, and I don't believe
 

that it's — that what you're saying is counter
 

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to anything —
 

DR. ZIEMER: Use the mike, Tony.
 

DR. ANDRADE: I don't believe that it's
 

counter to anything that I brought up, and I
 

really feel strongly that we're always going to
 

have seven out of ten people voting on an issue.
 

DR. ZIEMER: Okay, Sally.
 

MS. GADOLA: I just had just a little
 

aftermath. I think it's important — and this is
 

probably going to be already stated in other ways
 

— and that is that it's clear as to who
 

abstained, and those that objected, who they were
 

that objected and why they objected, because that
 

might be something important later on.
 

DR. ZIEMER: Thank you. And certainly that
 

would all be in the record, yes.
 

Other comments?
 

[No responses]
 

DR. ZIEMER: I'm going to ask if any of the
 

Board members want to volunteer to help a little
 

while tonight in drafting something.
 

Okay, I've got Roy — this becomes a working
 

group — Roy and Tony. Okay, we've got Wanda,
 

Sally. Last chance. Okay, and I'll work with
 

them. That's half the committee.
 

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Now for the other half, guess what you have
 

to — no. We don't have a job for you right yet.
 

Okay, good. Any other comments, staff
 

comments? I would like to have at least one
 

staff member with us. Larry, you or some of your
 

staff —
 

MR. ELLIOTT: Always be here.
 

DR. ZIEMER: Help this evening on this, yes.
 

Right.
 

MR. ELLIOTT: It goes without saying —
 

DR. ZIEMER: We'll allow them to eat supper,
 

but —
 

MS. MURRAY: Excuse me, Dr. Ziemer, I only
 

heard three names.
 

DR. ZIEMER: Oh, I've got Roy DeHart, Tony
 

Andrade. I think we’ve got — Wanda also
 

volunteered, Wanda Munn. Sally did, and I did.
 

MS. MURRAY: Thank you.
 

DR. ZIEMER: Okay.
 

UNIDENTIFIED: (Inaudible)
 

DR. ZIEMER: Is that — no, that's not a
 

quorum. We can't conduct — we're not going to
 

conduct business. It is a working group.
 

Actually, it's a subcommittee. It’s not a
 

working group; a subcommittee. Call it a
 

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subcommittee.
 

MR. ELLIOTT: But I would add that there's
 

clearly a definition on quorum for us to hold a
 

meeting. We must have six to hold a meeting, so
 

that's a clear definition we do have. But that's
 

separate from the quorum —
 

DR. ZIEMER: Right, but I think the
 

sentiment that we heard was that — but let's not
 

do that if we can avoid it. Let's find time when
 

all can be there if possible, or most. And then
 

if there needs to be a vote, possibly we do some
 

electronic things yet.
 

Okay, I think we have the comments recorded.
 

I hope mine agree with what the official
 

recorders’ are, otherwise the document may look
 

very different.
 

Okay, we're going to proceed with the agenda
 

item. The next item on the agenda is to get a
 

lot more detail on the probability of causation
 

rule — background, scientific and technical
 

basis. And for that Ted Katz of NIOSH is here.
 

And Ted, are you going to — yes, there you
 

go. Please proceed.
 

MR. KATZ: Thank you. And special thanks to
 

the Board. We're really very happy to finally
 

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have you here. It's been a long wait to get your
 

advice on these rules. I've been involved in the
 

development of these rules since the beginning,
 

and we've been wishing for six months to have
 

you. So it's great to finally have you indeed.
 

I'm going to be giving background — as you
 

see, I'm Ted Katz, I'm sorry, with NIOSH — I'm
 

going to be giving you a general background.
 

This whole process of helping you, help you get
 

into, find your way into our shoes so that you
 

can advise us on how to finalize these rules in
 

the best way possible.
 

And then I'll be followed on each of these
 

rules by Jim Neton and Mary Schubauer-Berigan —
 

in the other order, actually — who'll be giving
 

you a lot more technical and scientific detail.
 

So my presentations are going to be very general,
 

surficial maybe.
 

Okay, this is the overview of my talk. I'm
 

going to be discussing the purpose of the HHS
 

guidelines. What are they going to be used for,
 

how are they going to be used? What are the
 

basics of determining cause? My presentation's
 

going to be very elementary, but I think
 

important for public discussion on these issues.
 

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And then I'm going to speak about what
 

Congress requires of us with respect to
 

probability of causation, and finally what our
 

goals are here, what we bring, NIOSH brings to
 

the table. And let me start right away, then,
 

with the purpose here.
 

Congress requires the DOL to determine
 

whether or not a cancer was at least as likely as
 

not caused by radiation arising from DOE
 

employment. What are the basics of determining
 

cause — sorry. It requires DOL to make these
 

determinations using these guidelines, so this is
 

the only recipe that's going to be applied.
 

And the requirement applies — and Larry
 

spoke to this earlier — to all non-SEC — that
 

means Special Exposure Cohort — claims. And as
 

Larry explained earlier, that also means people
 

who are in this Special Exposure Cohort but who
 

have a cancer that doesn't fall within the list
 

of specified cancers. And there's all sorts of
 

cancers. To give you some examples, skin,
 

prostate, cancer of the larynx.
 

What are the basics of determining cause?
 

We have four elements here. There are actually
 

five — I'll add to this. First, cancer risk
 

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models. We need to know the relationship between
 

radiation dose and the chance of getting cancer.
 

And scientists have developed ways to bring
 

together the science base and mathematics to
 

produce an estimate, an estimate of cause, at
 

least for an individual in this case.
 

We also need associated with that — which
 

I've left off this list here — the type of
 

cancer. Cancers differ in their sensitivity to
 

radiation, so we need to know that. We need to
 

know the radiation dose for the claimant, or
 

doses, as it may be. We need a policy for
 

addressing uncertainty, and we need a policy for
 

addressing unknowns, and I'm going to get more
 

into this.
 

And in my talk I'm going to answer questions
 

as I go forward, so you may want to bust in and
 

ask a question, but you may want to just let me
 

roll first.
 

Addressing uncertainties: There are no
 

methods that will prove whether or not a cancer
 

was caused by a person's radiation dose. So what
 

we have instead are research on populations that
 

have been exposed to higher levels of radiation
 

than the normal population, and comparisons of
 

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the rate of cancers among those populations with
 

higher doses than the normal population.
 

So in those studies when you have — when you
 

find that the higher exposed population, for
 

example, has double the number of — rate of
 

cancers as the normal population, something
 

that's referred to as a doubling dose, that would
 

— you would apply that to an individual and say
 

that person has a 50 percent chance of having had
 

his cancer caused by the radiation. Or if there
 

were triple the number of cancers, then that
 

person would have a two-thirds chance that his
 

cancer was caused by the radiation. But this is
 

the basis of these mathematical models.
 

And then EEOICPA applies what's a pretty
 

common rule of thumb for deciding causation,
 

which is at least as likely as not, or a 50-50
 

percent chance.
 

But it isn't quite as simple as this, and
 

that's what this is about with respect to
 

uncertainty, because the cancer studies that I
 

just referred to are not perfect. They have
 

limitations, and that means there is uncertainty
 

about the estimate that they would give you. In
 

addition, you're applying those cancer studies
 

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possibly to a different population that has
 

differences, so there again you have
 

uncertainties that arise that affect the
 

reliability of the number that you come up with
 

for an individual.
 

All these uncertainties in the process, and
 

you have uncertainties with dose estimates, too.
 

You have uncertainties because the technology of
 

dosimetry is limited, because procedures may not
 

be applied correctly, because doses may not be
 

recorded, all sorts of reasons. You have
 

uncertainties about the dose that you're bringing
 

to the formula, to your mathematical model as
 

well.
 

And all these uncertainties result in you
 

really not having, at the end of the day, a
 

single estimate you can give people. I mean, you
 

may come up with a single estimate, but there
 

isn't a single estimate that represents that
 

person's chance that their cancer was caused.
 

You really have a range of estimates with
 

something's that's called by scientists a
 

“central tendency” to it. Scientists like to use
 

that central tendency or that sort of best
 

estimate when they're doing research for
 

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describing the experience or describing that
 

cause, that level of cause.
 

But we have a different situation here
 

because the decisions we're making aren't
 

decisions related to research; they're decisions
 

that affect people's lives directly. And so you
 

can actually do away with this problem of
 

uncertainty. You can minimize that or reduce
 

your uncertainty by instead of taking your best
 

estimate, your central tendency, going towards
 

the extremes.
 

If you go up and you go to a higher estimate
 

of dose within that range of estimates, you can
 

be more certain that that estimate, if you apply
 

that to the individual, is going to be at least
 

as high if not higher than the true level of
 

causation that might be, if you could ever know
 

the truth. Likewise, you can go to the other
 

extreme below. If you go to a very low estimate
 

within the range of estimates, a very low dose,
 

you can be very certain that that person's dose
 

was above that low estimate that you assign.
 

So there's — ironically, by going to extreme
 

levels in the estimates, you can be much more
 

certain about your decision, which ends up being
 

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important. And the policy question is, how
 

certain should our estimates be? And I'll answer
 

this, that Congress actually answers this for us
 

to a large extent.
 

But let me talk about addressing unknowns.
 

There are many cases for which we will not —
 

there are various issues for which we have
 

unknowns, and there are many cases for which we
 

will not know, for example, the primary cancer of
 

the employee. Now this is important because all
 

epi models are based on the primary cancer, the
 

place where the cancer started, not where it
 

metastasized to.
 

In addition, cancer models. You have for
 

very rare cancers — the rarer the cancer, the
 

fewer the cases, the fewer — the less experience
 

you have about that cancer, the more uncertainty
 

you have about your estimates. And so you have a
 

situation where in some cases with rare cancers
 

you have a choice between using a more general
 

model of cancer that lumps several cancers
 

together and has more certainty, or using a very
 

specific model of cancer that has a very high
 

level of uncertainty. And I think if you've seen
 

the public comments, you've seen that this is an
 

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issue that's of concern to many people.
 

So there's not always a single best cancer
 

model in any event. Science won't sort out that
 

issue for you where you have too small numbers.
 

And the policy question is, again, how can DOL
 

make fair, objective decisions in the absence of
 

a single best scientific answer?
 

Now what does Congress require of us here?
 

They require — and I'm going to amend this first
 

bullet a bit, not that it's not okay, but it
 

raises issues for dose reconstruction, which
 

we'll talk about later — but it requires that we
 

use the dose estimates, we use dose estimates.
 

And it requires that we enable DOL to determine
 

whether a cancer was at least as likely as not.
 

That's the 50 percent chance or better caused by
 

radiation.
 

It requires that we take into account other
 

factors as feasible, and it mentions among
 

factors we might take into account, smoking. It
 

requires that we use the radio-epidemiologic
 

tables and the upper 99 percent credibility
 

limit.
 

Now using the radio-epi tables and 99
 

percent limit, one, ensures that we're on the
 

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tract of using risk models. That's what we have
 

to do. We don't have an option there. And using
 

upper 99 percent credibility limit answers that
 

question that I raised earlier about how certain
 

we have to be.
 

Well, Congress says we need to be very
 

certain, in effect, and we need to be very
 

certain on the safe end for claimants. In other
 

words, we need to use a very high estimate, that
 

99 times out of 100 is going to be higher than
 

the estimate or the actual number, if such an
 

actual number could be known, the true number of
 

what probability there was that that cancer was
 

caused.
 

So we thank Congress for that major issue
 

being resolved. And that, by the way, is
 

consistent with policy that's already applied by
 

the Department of Veteran Affairs for atomic
 

survivors, veterans.
 

Now we're also required to address every
 

type of cancer. Though this isn't explicit, it's
 

implicit. Nothing is excluded in the
 

legislation. So this is different from the
 

Special Exposure Cohort where there's a list of
 

cancers. We're not giving a list. And this has
 

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implications when it came to our having models
 

available for determining probability of
 

causation for all cancers.
 

And finally, it requires that we obtain your
 

advice in producing these guidelines.
 

But what are our goals? And Kathy Rest
 

spoke very well to this. In the big sense, our
 

goal is to honor the intent of Congress here to
 

the best of our ability.
 

In particular, we want to make the best
 

available use of the best available science. A
 

lot of our work is based on work that preceded us
 

at the National Academy of Sciences; at NCI,
 

which did the developmental work; the National
 

Academy of Sciences, which gave recommendations
 

about that work, and that's NIOSH-IREP. And
 

Mary, who follows me, will be talking about that
 

in detail. And then building on that with NIOSH
 

experience in doing epi research.
 

And we want to ensure that claims receive
 

the benefit of the doubt in terms of uncertainty
 

and unknowns. And uncertainty, the biggest fish
 

in that pond we've just talked about, Congress
 

made the decision there, although there are other
 

issues.
 

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With respect to unknowns, I'll just give you
 

a couple of the most salient examples. With
 

certain leukemias which are rare we don't have a
 

best cancer model. We have a very specific model
 

to that leukemia, and we have a more general
 

leukemia model. And what we have said in effect,
 

to give the benefit of the doubt to the claimant,
 

not being able to make a scientific answer as to
 

which is best, is we've said try them both, and
 

whichever produces the higher probability of
 

causation, use that.
 

To give you another example, primary
 

cancers. Again, as I said, for many people — and
 

this is particularly going to be true or almost
 

always going to be true when it is true for where
 

the person's deceased, and we're working with a
 

death certificate and we don't have medical
 

records — we're not going to necessarily know the
 

primary cancer. And so what we've said here in
 

effect is take all the likely primary cancers,
 

from what science can tell us as to what's
 

likely, and run them all; and whichever produces
 

the highest probability of causation, use that.
 

And of course, if you run into one that already
 

puts them over into being compensated, then you
 

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can stop.
 

Now we've, through these sort of measures,
 

established procedures that DOL can apply
 

objectively and consistently for every claim. We
 

didn't want to produce a process, given the
 

volume of claims we're dealing with. Especially
 

in our strivings for transparency and so on, we
 

wanted to set out objective, hard, fast rules
 

rather than, for example, assembling a committee
 

to deal with certain cases or whatever, and
 

dealing with them subjectively and not
 

necessarily consistently throughout the program.
 

And then my final point about making
 

procedures as transparent as possible for the
 

public, we do that again through these objective
 

criteria that we give versus a black box sort of
 

operation. And as Mary will talk to you again
 

about, too, NIOSH-IREP is available for everyone
 

to use. To operate you can plug in your own
 

numbers. You can look at the basis for all the
 

assumptions that are in IREP and all the science
 

that's in IREP. It's a completely open process
 

that someone else can make the determinations
 

just as we can, and understand how, where they
 

came from and why.
 

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And that concludes my prepared presentation.
 

And I'd be glad to take — I'd be glad to take
 

questions now, or you may want to await Mary's
 

presentation, as well. It's really your call.
 

DR. ZIEMER: Well, let's take a moment and
 

see if there are immediate questions on Ted's
 

presentation.
 

[No responses]
 

DR. ZIEMER: Let's then proceed with Mary's,
 

and then we can cover both in one swoop.
 

DR. SCHUBAUER-BERIGAN: Good afternoon. Can
 

everyone hear me, first of all? I have a
 

tendency to speak somewhat softly, so if those of
 

you in the rear can't hear me at any point, just
 

sort of wave your hand and I'll speak up.
 

My name is Mary Schubauer-Berigan, and I'm a
 

research epidemiologist in the Health-Related
 

Energy Research Branch, which many of you may be
 

familiar with. It's a group that conducts
 

research related to epidemiologic studies of
 

Department of Energy workers.
 

I'm very happy to be here today to talk to
 

you about the basis, the technical and scientific
 

basis, for the probability of causation rules.
 

And I'll be attempting to go into a bit more
 

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detail on several of the issues that Ted has
 

already covered.
 

First I'd like to sort of walk you through
 

the basics of probability of causation, and some
 

of this may be reiterating Ted's points, once
 

again. First, it's important to recognize that
 

the concept of probability of causation is based
 

on the concept of assigned share. This is a term
 

that has been used in the insurance industry and
 

several other applications. It really applies to
 

populations and not to the individual, and so as
 

Ted has indicated, it's really impossible to
 

determine for an individual whether or not — what
 

actually was the cause of their cancer. The
 

assigned share, which is also sometimes referred
 

to as the attributable fraction in epidemiology,
 

estimates the proportion of disease in the
 

population that would not have occurred had that
 

exposure not taken place.
 

We are approximating the probability of
 

causation — I'll call that PC for short — by the
 

calculation of assigned share. Some have pointed
 

out that it's not technically accurate to equate
 

probability of causation with assigned share, but
 

because this is the best way we have to
 

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approximate it at the present time, we will be
 

using that term interchangeably.
 

As Ted indicated, as these methods have been
 

developed, we allow for the incorporation of
 

uncertainty in both dose, the dose-response
 

relationship for various cancers, and also
 

uncertainty in the importance of various factors
 

that modify that risk.
 

As Ted indicated, EEOICPA requires the use
 

of a standard referred to as “likely as not,” or
 

a 50 percent probability of causation after the
 

incorporation of uncertainty. This approach has
 

been criticized by some, and it's difficult to
 

get into the issues that have been criticized at
 

this point, but it's been fairly well
 

acknowledged that this is — the probability of
 

causation method is really the only available
 

method we have at this point to use with this
 

population.
 

Okay, I wanted to illustrate a calculation
 

of the assigned share of the probability of
 

causation. It is defined as the risk from
 

radiation exposure, also known as the excess
 

relative risk, divided by the sum of the
 

background risk and that risk from radiation
 

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exposure. And there's an alternative way of
 

expressing this, which is since the excess
 

relative risk is equivalent to the relative risk
 

minus one, it's simply the relative risk minus
 

one divided by the relative risk. And those of
 

you who are epidemiologists or are familiar with
 

risk assessment understand the concept of
 

relative risk.
 

In general terms, this is defined here as
 

the relative risk of cancer at a given dose level
 

compared to a similar unexposed population at a
 

specified age, sex, age at exposure, time since
 

exposure, or whatever other factors have been
 

found to modify that relationship. So you might
 

correctly guess at this point that we estimate
 

relative risk from epidemiologic analyses, and
 

you would be correct.
 

Because we know so much about the
 

relationship between ionizing radiation and
 

cancers, it's actually possible to produce
 

separate models for each cancer or for different
 

groupings of cancers, depending on the rarity of
 

the cancer and the population that's being
 

studied.
 

One factor that is very important that may
 

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not always be evident is that it's not always
 

clear how the relative risk that you observe in
 

one population should be transferred to a
 

different population. Here an example might be
 

the study of the Japanese atomic bomb survivors,
 

which is considered one of the premier studies of
 

the association between cancer risk and radiation
 

exposure, how to apply those risks that were
 

observed to the population of Department of
 

Energy workers who might be claimants under
 

EEOICPA.
 

The models also may incorporate uncertainty.
 

Those of you who do epidemiologic research or who
 

are familiar with it understand that you're
 

usually estimating relative risks with some
 

uncertainty about them, just due to statistical
 

uncertainty in the models that have been
 

produced. That's one source.
 

A second source is the uncertainty that's
 

associated with the exposure of the population
 

under study. And to continue my analogy using
 

the Japanese atomic bomb survivor study, there's
 

uncertainty about the doses that were experienced
 

by those atomic bomb survivors.
 

A third source of uncertainty is uncertainty
 

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in what's known about the effects of confounding
 

factors, such as age, sex, race, ethnicity, et
 

cetera.
 

As I mentioned earlier, there's also
 

uncertainty about how those relative risks should
 

be transferred to a new population.
 

And lastly, there's additionally uncertainty
 

associated with the exposure of the claimant.
 

And this slide gives you an illustration of
 

how uncertainty about all of these factors could
 

contribute to uncertainty in the estimate of
 

probability of causation.
 

As an example, we have a man who is exposed
 

to 11 rem of high energy photons at age 40. If
 

he was diagnosed with leukemia at age 50, one
 

might try to estimate the probability that his
 

leukemia was caused by that radiation exposure.
 

Using studies of people exposed to radiation and
 

observing the levels of radiation exposure that
 

led to increased levels of cancer risk, the best
 

estimate of probability of causation for this
 

population in this exposure is 34 percent,
 

defined as the median estimate of the probability
 

of causation.
 

However, after considering the various
 

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sources of uncertainty, given what we know about
 

the radiation exposure and leukemia risk, you
 

actually have a distribution of values with
 

variable likelihood or probability, and that
 

leads to this probability density function.
 

As Ted mentioned earlier, we might want to
 

use a very conservative estimate of the
 

probability of causation, and Congress has in
 

fact specified that we do so. So for this
 

individual, the upper 99th percentile on their
 

estimate of probability of causation is actually
 

65 percent. And under EEOICPA this is the value
 

that would be used to determine, by Department of
 

Labor, what the probability of causation is for
 

this person.
 

I wanted to talk a little bit — because
 

we've mentioned that this program has some
 

historical precedent, I'd like to talk about that
 

precedent for a few minutes.
 

The first experience was by the development
 

by the National Institutes of Health of a series
 

of radioepidemiologic tables in 1985. This
 

method was reviewed by the National Academy of
 

Sciences at that time, and it was based on
 

epidemiologic analyses, primarily of the Japanese
 

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atomic bomb survivors' experience. There were
 

also models incorporated from studies of radium
 

224 for bone cancer.
 

The method modeled risk for 12 different
 

cancers, and was primarily concerned with
 

external radiation. The cancers are listed here.
 

Those of you who are familiar with the
 

radiobiology literature or radiation epidemiology
 

understand that there is a lot of controversy
 

about factors such as dose-rate effects — that
 

is, does the risk of a certain dose of radiation
 

depend on the rate at which it's received?
 

The original tables assumed no adjustment
 

for dose-rate effects, but used a linear-


quadratic dose response model for all cancers
 

except for breast and thyroid, which has the
 

effect of reducing the risk per unit dose at low
 

levels of dose. And it applied a constant
 

relative risk model for most cancers except
 

leukemia and bone, which was transferred in an
 

additive fashion to the U.S. population.
 

Some of the aspects of the 1985 tables that
 

are relevant here are that it did have some
 

rather serious limitations. It really was
 

designed to be used only for external radiation,
 

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with a couple of exceptions. And it had poor
 

assessment of probability of causation from high
 

energy, high-LET dose, such as alpha dose from
 

plutonium exposures. It also — it did
 

incorporate uncertainty, but it did so rather
 

crudely, using multiplicative factors.
 

It was also rather difficult to implement.
 

I don't know if any of you are familiar with
 

these tables, but the book is about a couple
 

hundred pages long, and the tables are very
 

extensive throughout them and require a bit of
 

prior knowledge and experience to actually
 

implement. Also very importantly, these were
 

meant to be updated every few years.
 

Currently they're being used as source
 

models for the Atomic Veterans Compensation
 

Program, and in general it's believed that these
 

are a rather good fit to the dose scenario,
 

although there is some concern about high-LET
 

exposures among those atomic veterans.
 

Expert judgment is frequently used. As I
 

mentioned, there are only 12 cancer sites that
 

are modeled in there, so if you've got a cancer
 

to consider with — outside that list, you must
 

use expert judgment to determine the adjudication
 

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of a claim. This apparently posed less of a
 

problem for the VA than it might for DOL, because
 

they were processing approximately 300 to 400
 

claims per year.
 

It was recognized — several of these
 

limitations were recognized to be rather serious,
 

and several years ago the National Cancer
 

Institute agreed to update these
 

radioepidemiological tables. And I saw earlier
 

that one of the developers is here with us, Dr.
 

Charles Land from NCI.
 

This was done because of the availability of
 

new data. Atomic bomb cancer incidence data
 

through 1987 was newly available to do this.
 

Improved computational methods for both the risk
 

modeling from the A-bomb survivors and the
 

incorporation of uncertainty made it easier to
 

produce better models and ones that could be
 

implemented more easily.
 

I'd like to outline some of the changes that
 

the NCI tables, as of their review by the
 

National Academy of Sciences in November of 2000.
 

Some of the changes that were implemented is
 

that they increased the number of cancer sites
 

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quite dramatically, from 12 to 13 up to 33 total.
 

They did eliminate the radium 224 bone cancer
 

models and the radon lung cancer models at that
 

point in time.
 

They incorporated much more detailed
 

uncertainty analyses, adding factors for dose-


rate adjustment for low-LET radiation. Low-LET
 

radiation, for those of you who are not familiar
 

with that term, is what we refer to as
 

penetrating ionizing radiation, such as photons
 

or X-rays. They also added radiation quality
 

factors for high-LET risk estimation.
 

However, this was still directed at the time
 

towards the VA's Atomic Veterans Compensation
 

Program, since EEOICPA didn't exist at that time.
 

And it produced, very importantly, a program, a
 

computer program, that could be used by
 

individuals with less experience in these areas
 

rather than the set of complex tables that had
 

been produced previously.
 

Their methods were also reviewed, as I
 

mentioned, by a National Academy of Sciences
 

panel, and responses received. The status of the
 

NCI version is that it's in draft, as I
 

understand it. I don't know when the final is
 

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expected, but perhaps Dr. Land could address that
 

sometime today if those of you who may be
 

interested want information about that.
 

As we reviewed the NCI's program, we
 

identified limitations that we felt were
 

important for compensation of DOE workers. While
 

there was the addition of quite a bit of
 

extension of the models to apply to high-LET
 

exposures such as plutonium, there still remained
 

no radon in lung cancer models.
 

The RBE values, the relative biological
 

effectiveness values — which are similar to
 

quality factors — were highly uncertain for bone
 

marrow and several other sites. And these are
 

important exposures for the DOE work force, so we
 

felt that those needed more intensive attention.
 

And the dose-rate adjustment factors for high-LET
 

radiation were not addressed in that draft.
 

Also, as Ted mentioned, we had the
 

responsibility to consider all cancers, not just
 

specific cancers that happened to have models
 

associated with them, and there were several that
 

we felt were very important that needed to be
 

addressed — skin, bone, male breast cancer, and
 

several others came to mind.
 

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An additional problem is that several of the
 

cancer sites result in models that are unlikely
 

to result in a compensable claim for cancers that
 

have been shown to be elevated among the DOE work
 

force. And this raises the question of whether
 

supplementation of the Japanese atomic bomb
 

survivor data should occur with the results of
 

other studies, especially studies of DOE workers.
 

One factor we identified as important for
 

our program is temporal changes in U.S.
 

background cancer rates were not incorporated,
 

and the NCI program emphasizes the current cancer
 

rates, which may be relevant for the VA because
 

they are processing more current claims.
 

However, EEOICPA is the first program of its kind
 

for DOE workers, and it will be expected that
 

claims could come in from all periods of time
 

through which DOE has been in operation.
 

And Ted already covered this point, but how
 

should we handle metastatic cancers when the
 

primary site's unknown? And I believe this is
 

lastly, how should probability of causation be
 

estimated for multiple primary cancers?
 

As all of the other agencies can attest,
 

there was a very aggressive time frame for the
 

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development of probability of causation rules
 

under this program. And our approach was to use
 

the existing NCI methodology where appropriate,
 

especially given the level of scientific review
 

that this method had undergone, and we included
 

being very interested in their modifications that
 

were developed to address the NAS panel review
 

comments.
 

We attempted to separate the limitations
 

into those amenable to short-term versus long-


term solution. And we tried to work with NCI and
 

its contractors to address some of the
 

limitations. For example, the radon in lung
 

cancer model was incorporated, and this was
 

highly recommended by the NAS panel as well.
 

There was much more attention given to a
 

variety of different radiation exposure types,
 

and we have, I believe, now a total of five or
 

six radiation exposure types in the NIOSH-IREP
 

model. These have separate RBE and dose-rate
 

adjustment factors for each radiation type
 

specifically developed.
 

Finally, the software that NCI had developed
 

with its contractor was implemented into a NIOSH
 

version called NIOSH-IREP, which you'll see
 

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demonstrated hopefully in about an hour or so.
 

And lastly, we do remain involved in developing
 

long-term solutions to limitations in these
 

models for DOE workers.
 

Now what are some of the modifications that
 

were made for NIOSH-IREP? Well, initially we
 

recognized the need to add certain cancer models
 

for EEOICPA. For skin cancer we incorporated
 

analyses of the atomic bomb survivor skin cancer
 

incidence data that were done by Elaine Ron and
 

colleagues very recently.
 

Bone cancer has proven to be quite
 

challenging. There are data from the atomic bomb
 

survivor cohort. It's a very rare cancer, and so
 

there are not large numbers of bone cancers among
 

that group. However, there has been publication
 

of bone cancer risk coefficients by Pierce and
 

colleagues in 1996, which were used in a risk
 

assessment for plutonium in bone cancer risk by
 

Grogan and colleagues.
 

Since there was no male breast cancer risk
 

model, we used female breast cancer risk
 

coefficients applied to background male breast
 

cancer rates in the U.S. and Japan. And we added
 

models for connective tissue cancer, cancers of
 

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the eye, non-thyroid endocrine glands and “illdefined” cancers, and these were done using the
 

miscellaneous cancer risk model produced by NCI,
 

applied to these individual cancer background
 

rates in order to transfer the risk to the U.S.
 

population.
 

Very importantly, we determined that the
 

chronic lymphocytic leukemia should be excluded
 

at this time on the basis of the lack of
 

qualitative evidence that radiation exposure
 

causes CLL, and the lack of any quantitative
 

models available to estimate risk for this
 

specific type of leukemia.
 

We also developed an objective list of
 

cancer models that should be used to adjudicate
 

claims in which the primary cancer site is
 

unknown, and we did this using available data
 

from the National Center for Health statistics
 

relating cancers — secondary cancers to their
 

likely site of origin.
 

And lastly, we developed operational smoking
 

definitions for use in the lung cancer models
 

that are part of the NCI-IREP program.
 

What do we see as the future of probability
 

of causation calculation? Well, first, the NCI
 

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program is itself interim, and they anticipate
 

that periodic updates will result from new
 

scientific information.
 

One of the most important of these is the
 

recommendations of the BEIR VII panel, which is
 

an NAS-NRC group. Also very importantly, we need
 

to rely on the recommendations of the Advisory
 

Board for any changes to the models that are
 

required. And also very importantly, we are
 

working on ways to incorporate relevant changes
 

that need to be made based on the scientific and
 

public review comments that have been received
 

and that will still be received as part of this
 

process.
 

I just in the last few minutes — I think I
 

do have some time here — I wanted to talk about
 

some of the potential modifications that could
 

result in the future from new scientific
 

information.
 

Some of these possible long-term changes
 

include improvements in the risk models, or
 

reduction or better estimation of uncertainties.
 

I already mentioned the BEIR VII committee, which
 

is working to update risk coefficients for
 

various cancer models. We also believe that it's
 

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very important, where possible, to incorporate
 

input from epidemiologic studies of Department of
 

Energy workers, and that is a very important
 

future possible amendment that we believe needs
 

to be considered.
 

Changes that result from changes in
 

dosimetry practices, either at DOE sites or just
 

in our general knowledge about radiation
 

dosimetry, would also be elements that could be
 

amenable for long-term change.
 

One of the recommendations, or one of the
 

specific adjustment factors mentioned by the NAS
 

review of the National Cancer Institute models,
 

was consideration of adjustments for radio-


sensitive subpopulations. And you've all heard a
 

tremendous amount about the human genome project
 

and some of the fruit that that might bear for
 

our knowledge of cancer causation. And it's just
 

probably too early at this point to incorporate
 

information about radio-sensitive subpopulations
 

into these models.
 

Also, the EEOICPA language strongly suggests
 

consideration of interactions with other work
 

place exposures, and that is something we felt
 

was amenable to long-term consideration, but
 

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really couldn't be handled in this version of the
 

IREP program.
 

And now I'll be happy to take some questions
 

from those of you who have them.
 

DR. MELIUS: You mentioned the issue of
 

temporal change in cancer incidence rates.
 

DR. SCHUBAUER-BERIGAN: Yes.
 

DR. MELIUS: Do you have any idea what the
 

magnitude of that effect would be in terms of
 

individual —
 

DR. SCHUBAUER-BERIGAN: Right.
 

It varies by cancer, obviously. Some
 

cancers have become much more common over time.
 

I think their incidence has increased in the U.S.
 

population. In some cancers it has decreased.
 

The extent of that contribution to a change in
 

the probability of causation estimate is
 

difficult to assess without actually going
 

through the process of modeling it. That's just
 

one of the factors of uncertainty that is
 

incorporated into these models, and we haven't
 

tried to model that specifically.
 

DR. MELIUS: Okay. That was my question.
 

DR. SCHUBAUER-BERIGAN: Yeah.
 

DR. DeHART: You mentioned the epidemiology
 

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studies of DOE workers. Many of the plants have
 

had those studies ongoing for a period of time.
 

Do you have any feel for what the relative risk
 

overall might be? Are we talking about 1.2, 2,
 

3, 4 — as you look, generally.
 

DR. SCHUBAUER-BERIGAN: It would be really
 

difficult to answer that question without getting
 

very specific about details of the exposure. I
 

mean, anytime you talk about relative risk you
 

really have to define the exposure group. And of
 

course, workers who are exposed to higher levels
 

of radiation would be expected to incur higher
 

levels of risk.
 

And so without knowing the general exposure
 

or the average exposure among the DOE work force,
 

it's very difficult to estimate. And some
 

studies have found much larger increases than
 

that for specific cancers. Others have found no
 

elevation of risk or a smaller elevation of risk.
 

But it's very difficult to generalize across the
 

entire DOE work force.
 

Yes?
 

DR. ROESSLER: I might get myself mixed up
 

in presenting this, but when you talk about
 

cancers that — about which you have a lot of
 

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information, you will then have tighter bounds or
 

lower uncertainty levels, so it would be closer
 

to this best estimate. If you're talking about
 

something that's very uncertain you're going to
 

have these great big uncertainty bounds.
 

It seems like that if you pick — which, I
 

mean, Congress has done — the 99 percent level,
 

and you take two individuals, one who comes in
 

with a cancer for which there's a lot of
 

information known, it seems like that person's
 

going to be jeopardized because you're living
 

with those uncertainty limits which are much
 

tighter.
 

DR. SCHUBAUER-BERIGAN: Yes, that is a
 

source of a lot of the comments that have been
 

received.
 

And I don't know, Ted, if you wanted to
 

address that.
 

But the — in our discussions it was felt
 

that that's a very valid point. However, we were
 

basically — our hands were tied because of the
 

specifications of Congress on how this should
 

actually be — the compensation should be awarded.
 

It was on the basis of that upper bound of
 

uncertainty. And you are correct, that the less
 

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you know, the more uncertain you are, the higher
 

that upper bound becomes.
 

In a practical sense — and maybe Dr. Land
 

can speak to this — this is also a point that the
 

NAS panel brought up. And one of the amendments
 

that NCI has made has been to try to group
 

cancers into larger groups to avoid having these
 

extremely high estimates of uncertainty for very
 

rare cancers.
 

Charles, is that a fair —
 

DR. LAND: That's fair.
 

DR. SCHUBAUER-BERIGAN: — summary?
 

DR. LAND: Right.
 

DR. DeHART: We've been talking a bit about
 

the Special Exposure Cohort. Was any of these
 

kinds of studies applied in order to determine
 

that they would be sort of automatically found to
 

have a causation issue?
 

DR. SCHUBAUER-BERIGAN: You mean in
 

establishing the initial Special Exposure Cohort?
 

DR. DeHART: Yes, exactly.
 

DR. SCHUBAUER-BERIGAN: I don't believe so.
 

I couldn't speak to the minds of anyone who
 

established the Special Exposure Cohort, but I
 

don't believe that that was done.
 

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Yes?
 

MS. GADOLA: Under modifications made for
 

NIOSH-IREP, it says that you developed
 

operational smoking definitions for use in lung
 

cancer models. Could you elaborate on that a
 

little bit?
 

DR. SCHUBAUER-BERIGAN: Yes. There is an
 

adjustment for smoking status for lung cancer
 

only, and this was a feature of the original NIH
 

1985 tables that had been carried through the NCI
 

version of the tables. And we believe that those
 

were valid to incorporate on a scientific basis,
 

but in some cases — specifically how you define a
 

non-smoker — we had to develop a definition that
 

was based on the best sort of scientific
 

definition that's currently used.
 

And the one that we decided on was a
 

lifetime smoking rate of 100 cigarettes or fewer
 

throughout an entire lifetime, you would be
 

considered a never smoker, up to the point of
 

your cancer occurrence. And in cases of defining
 

your smoking level, we instruct Department of
 

Labor to question the person on their habits up
 

until the previous five years of the cancer
 

diagnosis. So whatever category you were in at
 

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the point five years before your cancer diagnosis
 

is your definition for the purposes of estimating
 

your probability of causation.
 

MS. GADOLA: Is smoking, then, the only type
 

of cancer that something else like another
 

carcinogen is really considered?
 

DR. SCHUBAUER-BERIGAN: Well, not
 

necessarily. I mean, one of the biggest
 

carcinogens is aging, the aging process. And age
 

is certainly an important factor that modifies
 

your risk, so that is incorporated. Cancer risks
 

due to radiation exposure differ in many — for
 

many cancers by your gender, and so that's also
 

incorporated in many of the risk models.
 

We did — and this is very important to
 

mention, so I'm glad you raised this question —
 

in the skin cancer models that were developed,
 

because skin cancer is primarily a function of
 

skin pigmentation which is a function of
 

race/ethnicity, we've incorporated a different
 

set of background incidence rates that are race-


and ethnicity-dependent. And so that is one
 

other cancer that has a different risk modifier
 

added to it.
 

MS. GADOLA: Okay. I was familiar with
 

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that, and I'm glad you included that. But I was
 

also thinking — and I think you have already
 

answered this — was some of the other chemicals,
 

because we don't know enough about them. Is that
 

true, although they are listed as carcinogens and
 

some of these employees might have been working
 

with them?
 

DR. SCHUBAUER-BERIGAN: Well, Larry alluded
 

to this in his presentation just before lunch.
 

You might remember that he mentioned we're
 

limited to considering radiation risk. So the
 

only extent to which we can consider chemical
 

exposure is the extent to which it modifies the
 

effect of the radiation. So if exposure to a
 

chemical increases the effects the radiation has
 

on your cancer risk, then those should be
 

considered. And at this point there's just
 

simply not enough information to allow us to do
 

that.
 

MS. GADOLA: Except for those in cigarettes.
 

DR. SCHUBAUER-BERIGAN: That's right,
 

because it has been intensively studied.
 

MS. GADOLA: Thank you.
 

DR. SCHUBAUER-BERIGAN: Yes?
 

MS. MUNN: A couple of times you referred to
 

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specific types of cancer that had found to be
 

excess in DOE workers. I don't know whether I
 

should address this to you or to Larry. I don't
 

think there was anything in the materials that I
 

received that identified those specific
 

categories of cancer. It would be very helpful
 

to me if I had something to —
 

DR. SCHUBAUER-BERIGAN: Yes. I don't know
 

that any of you have received or read many of the
 

studies of DOE workers, but one that's of great
 

interest is multiple myeloma, which has been
 

found to be elevated in certain cohorts. Another
 

cancer that frequently is mentioned is brain
 

cancer in the Rocky Flats cohort. And I'm sure
 

the OCAS staff would be happy to provide the
 

Board with papers and reprints on these things.
 

Yes?
 

DR. MELIUS: Can you comment on how the
 

model deals with age at first exposure, initial
 

radiation exposure?
 

DR. SCHUBAUER-BERIGAN: Well, actually, for
 

most cancers, I'd prefer to defer to Charles Land
 

on that. I actually have a slide later on that
 

talks about some of these effect modifiers, and
 

age at exposure's an important one. But it
 

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varies for different cancers. For most of the
 

cancer sites, age at exposure — increasing age at
 

exposure is thought to be associated with lower
 

cancer risk, so the younger you are at exposure
 

the greater your cancer risk. But it doesn't
 

apply to all cancers.
 

DR. MELIUS: If you're going to talk about
 

it later, that's fine.
 

DR. SCHUBAUER-BERIGAN: Anything else?
 

DR. ZIEMER: No other questions?
 

Now we will be looking at the IREP specifics
 

after the break, and that might raise some
 

additional questions as well. So —
 

DR. MELIUS: I was trying to figure out if
 

this was our last chance to ask questions —
 

DR. ZIEMER: No, no.
 

DR. MELIUS: — on some of these issues,
 

that's all. It wasn't clear.
 

DR. ZIEMER: This is just the first cut,
 

okay?
 

Okay, then we are going to take our break.
 

We'll reconvene at 2:45.
 

[Whereupon, a recess was taken from
 

approximately 2:25 p.m. to
 

2:47 p.m.]
 

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

order. And we're going to proceed with the next
 

item on the agenda, which is a review of the
 

Interactive Radio-Epidemiological Program, IREP.
 

And I think Russ Henshaw is going to kick us off
 

on that.
 

Russ, are you ready?
 

MR. HENSHAW: Yes, sir.
 

Good afternoon. It's a pleasure to be here.
 

I'm Russ Henshaw. I'm an epidemiologist with the
 

Office of Compensation Analysis and Support.
 

I'll be giving this presentation along with Mary
 

Schubauer-Berigan, who is serving two combat
 

tours today, two in a row. I'll start off and
 

talk a little bit about NIOSH-IREP and then do a
 

demonstration of the software, and then Mary will
 

come on and talk in a little more detail about
 

some of the features.
 

Now what is NIOSH-IREP? Basically it's an
 

interactive software program that, as the name
 

implies, is NIOSH's version of IREP. It's
 

designed under the guidelines of the EEOICPA to
 

calculate the probability that a worker's
 

compensation — that a worker's cancer was caused
 

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by occupational radiation exposure. It's
 

currently posted on the internet for public use
 

and comment.
 

The program incorporates cancer risk models
 

derived from tables developed in 1985, as was
 

mentioned previously, by the National Institutes
 

of Health, and then updated later by the National
 

Cancer Institute and the CDC.
 

Although the NIOSH version builds upon the
 

National Cancer Institute's methodology, it was
 

designed very specifically — NIOSH-IREP, that is
 

— to address the exposures and the risks
 

associated with the production of nuclear weapons
 

— that is, the cases of cancer among workers at
 

atomic weapon facilities, Department of Energy
 

employees, and contract workers.
 

What are the primary goals of NIOSH-IREP?
 

Well, the primary purpose, in a nutshell, is to
 

calculate the best possible estimate of causation
 

for each individual cancer claim. To accomplish
 

this the software incorporates statistical risk
 

models, as has been noted, for the various types
 

of cancer adjusted for individual risk factors,
 

such as age at exposure and age at diagnosis.
 

Of course, as has been mentioned, there are
 

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uncertainties, uncertainties associated with the
 

radiation dose and also with the probability
 

distributions that form the basis for the
 

statistical calculations. Under the provisions
 

of EEOICPA, however, NIOSH-IREP is designed to
 

utilize these uncertainties in a way that's
 

intended to give the benefit of doubt to the
 

claimant.
 

Additionally, the intention was to make the
 

process of calculation open, accessible, and
 

self-documenting by including on-line
 

descriptions of model details wherever feasible.
 

It's designed to be user-friendly, and to the
 

extent possible, given the complexity of the
 

statistical risk models, really to demystify, if
 

possible, the process of probability of
 

causation.
 

And a lot has been said about providing the
 

benefit of doubt to claimants, and that is a
 

major goal, by applying the “as likely as not”
 

standard that's incorporated under the provisions
 

of EEOICPA — that is, is it as likely as not that
 

an individual's cancer was caused by his or her
 

work place exposure to radiation rather than by
 

something else?
 

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To meet this standard, the program basically
 

overlays a range of causation likelihoods,
 

similar — known as credibility limits. That's
 

similar to confidence intervals. And that
 

probability distribution is overlaid around the
 

causation point estimate for each claim. If the
 

upper 99th percentile of the distribution falls
 

at 50 percent or higher, then the claim is
 

considered compensable.
 

For our demonstration of the program, we'll
 

go through each step using input data for a
 

hypothetical claim, maybe two or three depending
 

on the time, and then we'll view the subsequent
 

probability of causation result. We'll also show
 

you some of the documentation in the help files
 

that are incorporated into the web version of the
 

software.
 

First, though, how do you actually find
 

NIOSH-IREP on the web? Well, the most direct way
 

is to type in the exact internet address, which
 

is shown on the screen and also in your handout.
 

But given that that looks like a series of
 

numbers from a random number table, there is an
 

easier way to get to it. For one thing, you
 

wouldn't have to have that address in front of
 

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you. And that way is to go directly to the
 

cdc.gov/niosh site. When you reach there you
 

simply click on OCAS, Office of Compensation
 

Analysis and Support. That's the OCAS, the link
 

to the OCAS home page. And at the home page you
 

click on Probability of Causation, NIOSH-IREP —
 

and I'll show you this later, if we have time,
 

when we access the software live, so to speak.
 

Finally, you would click on NIOSH-IREP, and then
 

click on the actual link to the NIOSH-IREP
 

software.
 

When we get to the demonstration, by the
 

way, you might want to turn to one of the two
 

operating guides in your handouts and in the
 

notebook. One is a two-page short version. The
 

other is the longer, more documented version. It
 

might help you if you attempt to run some claim
 

scenarios yourself at a later date.
 

Anyway, what input information do we need
 

for NIOSH-IREP? Well, first we need the gender,
 

the year of birth, and the year of diagnosis.
 

We need the type of cancer; and ethnicity,
 

but only if it's skin cancer, otherwise it
 

doesn't play a role in the causation estimate.
 

We need smoking data, if lung cancer, and that
 

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also includes cancer of the trachea and bronchus.
 

And of course, as Dr. Schubauer-Berigan pointed
 

out earlier, we're only interested in smoking
 

data prior to the diagnosis of cancer.
 

We need the equivalent organ dose — and
 

incidentally, there's a typo there. That should
 

be small cSv for centisievert, which is the same
 

thing as a rem. We need the year or years of
 

exposure, the exposure rate, the radiation type
 

and range, the organ dose, et cetera. And Mary
 

will go into that in more detail later after we
 

demonstrate the software.
 

Before I get into the actual demonstration,
 

I do want to just touch again on this issue of
 

multiple primary cancer sites. This is a source
 

of some confusion among claimants and others who
 

call about the program. And basically, as has
 

been stated, if you have more — if a claimant has
 

more than one primary cancer site, it's necessary
 

to run each cancer independently through the
 

software and come up with separate, independent
 

probability of causation results.
 

Following that, you take the results and
 

plug them into this equation, and I have an
 

example here at the bottom. In this case, let's
 

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say that hypothetically there were two primary
 

cancer sites. We ran each of them through the
 

software and came up with a probability of 40
 

percent. That's the upper 99 percent credibility
 

limit, or .4 in the equation. And the second
 

one, let's say hypothetically also was .4. Well,
 

taken — either cancer taken by itself would not
 

be compensable under the guidelines. However, by
 

plugging them into this equation, wind up with 64
 

percent, .64, and that would be a compensable
 

claim.
 

Now we'll actually demonstrate the software.
 

Hopefully it's still somewhere in this little
 

laptop from our web site. We'll run a
 

hypothetical claim scenario. Questions are
 

welcome at any time, and with any luck perhaps
 

either Mary or I can actually answer the
 

question. So let's, without further ado, as they
 

say, let us begin.
 

For the sake of time, I've already navigated
 

through the NIOSH — the CDC and NIOSH screens to
 

get to the opening page of NIOSH-IREP. This is
 

the opening screen. The first thing — and if we
 

have time, if anyone is interested, I'll be happy
 

to back up and actually navigate to it later.
 

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First thing to do is click on the BEGIN button.
 

That is the data input screen.
 

For a hypothetical example, let's take a
 

case of lung cancer. We'll leave the default as
 

male. The birth year is 1951, and the year of
 

diagnosis is 1991. It's not necessary just to
 

calculate causation to enter in the name, claim
 

number, and Social Security number. Of course,
 

when the Department of Labor calculates
 

probability they will need to do that.
 

Then we click on ENTER A DIAGNOSIS. And
 

this plays no part in the actual calculation, but
 

at the end of the — after we wind our way through
 

the software the program prints out a summary
 

report, and this will appear on the summary
 

report. So we'll type in lung; date of
 

diagnosis, 1991; and click on SUBMIT DIAGNOSIS.
 

Now we go to the cancer model. Again, this
 

is lung cancer, and the cancers are arranged
 

basically in numerical order by ICD-9 code. Lung
 

is 162. We enter that. Should an alternate
 

cancer model — oops, I think I clicked on
 

something by mistake. Let me back up.
 

In addition to the uncertainty of the
 

statistical risk models, there's some uncertainty
 

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with my vision. I have bifocals, and right on
 

the cusp of trifocals here, so. In fact, I'm
 

going to change glasses for a minute.
 

Okay, so we go to should alternate cancer
 

model be run? The answer is no in this case.
 

And the purpose of that, by the way — again, it
 

does not play a part in the calculation. It is
 

really a reminder, if there is more than one
 

cancer to be run through the software, it's a
 

reminder to the Department of Labor person who
 

will be actually operating this that when the
 

summary's printed out, he or she will see that
 

and remember to go back and run the second or
 

third or whatever cancer.
 

So we go to enter data. This is the inputs
 

for skin and lung cancer only. This is lung
 

cancer, so we'll enter that, we'll press that
 

button. Since it's not skin cancer we can
 

disregard ethnic origin. And in this case let's
 

say that — I'll pop this open for you, just to
 

show you the three choices are radon, radon plus
 

other sources, or just other sources. We'll say,
 

for this example, it's just other sources, no
 

radon exposure. And we'll say never smoked.
 

Now if you'll notice, there's — even though
 

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this is not a radon exposure, there is a one in
 

the block for number of radon exposures. I'm
 

going to — just to show you, so you don't make
 

the same mistake yourself if you play around with
 

this later, I'm going to change that to zero, as
 

one might intuitively think one should do, and
 

click on SUBMIT DATA. I can see the screen, but
 

I can't see any of you, by the way, so.
 

If you'll see there, there's a red error
 

message, number of exposures cannot be less than
 

one. If you're running this and forget and enter
 

the zero, then just disregard that. The way the
 

software is set up right now, unless either radon
 

or radon plus other sources is selected for the
 

exposure from — can't see the screen, either —
 

for the exposure from input, the software
 

actually disregards anything that's in the radon
 

box. However — 

DR. ZIEMER: There's a question here, Russ. 

DR. ANDRADE: Just a quick question — 

MR. HENSHAW: Sure. 

DR. ANDRADE: — while we're still on the 

screen. I'm really curious as to what the menu
 

for smoking history is.
 

MR. HENSHAW: Sure. It's never smoked,
 

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which as Mary — Dr. Schubauer-Berigan indicated
 

earlier, for our purposes means smoked less than
 

100 cigarettes in a lifetime prior to the
 

diagnosis — prior — is it up to five years of the
 

diagnosis, Mary?
 

DR. SCHUBAUER-BERIGAN: (Nods affirmatively)
 

MR. HENSHAW: And then the other choices —
 

former smoker, current smoker, unknown number of
 

cigarettes a day, and so forth.
 

DR. ANDRADE: Thank you.
 

MR. HENSHAW: Incidentally, if I'm bypassing
 

any of the screens, please feel free to shout out
 

and tell me to open it up, even if it's not
 

needed for this particular scenario. Be happy to
 

do that.
 

So I'll change this back to one, even though
 

it won't be counted in the calculation, just so I
 

can submit the data.
 

Oh, while I'm here, one other thing. I
 

mentioned that we'd look at some of the on-line
 

documentation — let me back up a second here.
 

just clicked on VIEW MODEL DETAILS, and you will
 

see an explanation of the model. And you'll see
 

that — you'll see things like this here and there
 

throughout the software, should you go back and
 

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play around with this yourself. When you see
 

anything like — any of the screens that have VIEW
 

MODEL DETAILS or anything like that, you're
 

likely to see some interesting information. In
 

fact, you're likely to — you're liable to see it
 

more than once or twice here, if you're as clumsy
 

as I am with your fingers.
 

But anyway, we'll go back and submit data,
 

and that was accepted.
 

DR. ZIEMER: Russ, why wouldn't you on that
 

one, that chart where you have confusion about
 

one or zero, why not just label that radon or
 

other sources, number of exposures, since that's
 

the category it's under? Wouldn't that remove
 

the confusion, or —
 

MR. HENSHAW: If it was labeled radon plus
 

other sources, it would — the program would
 

assume that there was radon exposure and factor
 

that into the calculation.
 

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

the instruction part for the user —
 

MR. HENSHAW: So the on-line —
 

DR. ZIEMER: If you go back — go back to the
 

other screen there.
 

MR. HENSHAW: Okay.
 

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DR. ZIEMER: Where it forced you to put in
 

the one —
 

MR. HENSHAW: Um-hum.
 

DR. ZIEMER: — for exposure, it says for
 

exposures to radon, number of radon exposures,
 

you're having to put one in there anyway 'cause
 

you have to show that you're exposing to
 

something, right? Is that why the one's there?
 

MR. HENSHAW: Just — yes, just to make the
 

program work, even though it disregards the
 

input. And they're working on fixing this. It's
 

a —
 

DR. ZIEMER: Oh, it needs to be labeled
 

differently.
 

MR. HENSHAW: Yeah, it can be confusing.
 

But I think the main point to remember is that no
 

matter what you have in there, it's not factored
 

into the calculations if you have OTHER SOURCES
 

checked for exposure.
 

MR. ELLIOTT: If this claimant was from
 

Fernald, though, you would want to choose radon
 

exposure for that entry. Right?
 

MR. HENSHAW: I would assume so, but I'd
 

refer that to one of our health physicists here.
 

UNIDENTIFIED: Possibly.
 

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MR. HENSHAW: Okay, we've entered the data.
 

Now we skip over — oh, I'm sorry. Now we go to
 

enter doses since it was other sources, not
 

radon. Then — well, let me back up a second here
 

just to clarify something.
 

You'll notice there's an input field for
 

number of exposures under exposure information.
 

We're going to — for this hypothetical case, just
 

for simplicity, we're going to say there was one
 

exposure. Now we need to enter the dose
 

information. Now had I typed in a two into that
 

field — if you'll notice, there's one line for
 

input data, one line for exposure. Had I typed a
 

two into that field there would be two lines;
 

three, three lines, et cetera.
 

So for this case we're going to say the
 

exposure year was 1981.
 

DR. DeHART: Where is the employee getting
 

that data? From DOE records, or what?
 

MR. HENSHAW: Well, initially, yes. But
 

part of the program also includes actually
 

interviewing each claimant or survivor, or
 

sometimes coworkers, to verify that and maybe
 

obtain additional information if it's available.
 

I'm going to say the exposure is chronic,
 

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and let's say this is — the radiation type is
 

alpha, we'll say from plutonium. We use the
 

lognormal distribution, and for the parameters —
 

the first parameter we put the actual number of
 

rems, the dose in rems, into the box for
 

parameter one, and we'll say it was 20 rem.
 

Leave that at two, and leave that at zero,
 

although for lognormal it doesn't matter what's
 

in the third box. For lognormal the parameters
 

are only the first two, the median and the
 

geometric standard deviation.
 

MS. MUNN: So what did you do in box two?
 

You had only one exposure?
 

MR. HENSHAW: Right. The two — it's not —
 

it doesn't — it's not related to number of
 

exposures.
 

MS. MUNN: I understand, but —
 

MR. HENSHAW: For — I'd probably refer that
 

question to Jim or one of the health physicists
 

for — or perhaps Mary, if you can answer that.
 

DR. SCHUBAUER-BERIGAN: The question is why
 

is there a two in there?
 

MR. HENSHAW: Why is there a two in box two?
 

DR. SCHUBAUER-BERIGAN: Right. My
 

understanding is that a dose of record is not in
 

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168 

the form of a distribution; it's in the form of a
 

single number. And so that could be approximated
 

using a distribution for organ dose that's called
 

constant in the pull-down menu, if you'd like to
 

do that.
 

However, as I mentioned in my presentation,
 

we have the ability to incorporate uncertainty in
 

the radiation dose of the claimant. And a very
 

typical distribution for an uncertainty
 

distribution is a lognormal for exposure data.
 

And so this is just a hypothetical example, but
 

for the case of Department of Labor, the health
 

physicist would reconstruct the dose and would
 

develop that particular dose distribution, and
 

would give the parameter estimates from that
 

process.
 

So this is something that a claimant is
 

likely to not know how to do before seeing their
 

dose reconstruction, which is why there is a
 

pull-down in there, as Russ is showing, for a
 

constant.
 

MR. HENSHAW: It's also, incidentally,
 

perhaps a good segue to clicking on this help
 

screen.
 

Again, these are more model details. This
 

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169 

attempts to provide some more information about
 

the distribution parameters. And there's also,
 

by the way, a good deal more information on this
 

and other model details for the program and for
 

probability of causation in your handouts and
 

notebook.
 

I'll close this help screen, and now we'll
 

submit the dose data.
 

Now we're back to the earlier screen, the
 

input screen. And now we've done — we've entered
 

all the information we need to enter to calculate
 

probability. All we need do is click on SUMMARY
 

REPORT and wait for the little invisible wheels
 

to turn, and we'll grind out some results.
 

And there it is. You'll notice that much of
 

the information that I mentioned was not actually
 

necessary for the calculations appears in the
 

summary report, including the information on the
 

primary cancer, the date of diagnosis, and so
 

forth, and the demographic information, name and
 

Social Security number. Pretty much spits out
 

just about everything we've plugged into it.
 

And we scroll down to the bottom, and there
 

are the actual calculation results. And as you
 

can see, this — this is driving me nuts. Bear
 

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with me here with the glasses change. But as you
 

can see, this individual's claim did not turn out
 

to be compensable because the 99th percentile,
 

the credibility limits, fell below 50 percent.
 

DR. ZIEMER: Russ, it might be instructive
 

to now go back with the same dose and increase
 

the uncertainty by raising the standard deviation
 

of the lognormal distribution from two to, say,
 

five.
 

MR. HENSHAW: Okay.
 

DR. ZIEMER: With the same dose.
 

MR. HENSHAW: I haven't tried that. I've
 

tried playing around with the data, with the
 

amount of rem, but not this one, so this might be
 

interesting. Did you say five?
 

DR. ZIEMER: Say five.
 

MR. HENSHAW: If you're doing this at home
 

and you happen to have a cable internet
 

connection, by the way, it goes really quickly.
 

This is a dial-up we're using here today.
 

So we'll scroll down to the bottom of the
 

page and — about 75 percent.
 

DR. ZIEMER: Yeah. This is instructive, and
 

I think points out that uncertainty in the
 

numbers does in fact help the claimant. This was
 

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in fact the intent of Congress, that if we don't
 

know very well the decision is made in favor of
 

the claimant. And I think it shows up here in
 

the model, and I just thought — 'cause I've tried
 

some of these, and I —
 

MR. HENSHAW: Yeah, it really bears —
 

DR. ZIEMER: — thought it would be helpful
 

to see how this plays out. And this, not only in
 

the dose numbers but also in the epidemiological
 

information, uncertainty in either one tends to
 

raise that number.
 

MR. HENSHAW: Yes, this does bear out the
 

point someone made earlier. Play around a little
 

bit more with the input data —
 

DR. ANDERSON: What about a cigarette
 

smoker?
 

MR. ELLIOTT: Leave the dose and GSD as is,
 

and change the smoking history.
 

MR. HENSHAW: Oh, okay. Should we go all
 

the way to the extreme?
 

UNIDENTIFIED: Go in the middle somewhere.
 

DR. ANDERSON: Just go to ten.
 

MR. HENSHAW: Ten to 19, or —
 

DR. ANDERSON: Yeah, that's good.
 

MR. ELLIOTT: Make it reasonable.
 

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MR. HENSHAW: The original result, before we
 

changed the second parameter, was 43 percent.
 

And then went — go to 80-something, I believe,
 

wasn't it? Claimant still meets the compensation
 

guidelines. It's significantly lower, though.
 

DR. DeHART: Try the next higher smoking
 

group, because people will say they smoke a pack,
 

typically.
 

MR. HENSHAW: That sets it up so you have to
 

scroll down to see it, too. It builds up the
 

suspense. It didn't have any effect, I don't
 

think.
 

DR. ZIEMER: Russ, if you'd put the
 

uncertainty on dose back at the original two, how
 

would the smoking have affected — the smoking is
 

— obviously is having some reduction on the —
 

MR. HENSHAW: Let's find out.
 

DR. SCHUBAUER-BERIGAN: Russ, I would
 

suggest the importance analysis. You might want
 

to click on the importance analysis first before
 

you do a lot more scenarios, just to show how you
 

can look at that.
 

MR. HENSHAW: I'm sorry, Mary, I can't hear
 

you. Could you say that again?
 

DR. ZIEMER: Importance analysis.
 

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173 

DR. SCHUBAUER-BERIGAN: You might want to
 

click on the importance analysis button before
 

you do a lot more individual scenarios,
 

intermediate results.
 

And I'll just say a word or two about that
 

before it shows up. This actually was designed
 

to kind of show the impact of changing various
 

factors or factors that are — of uncertainty that
 

are incorporated into the software program.
 

And first you see the range of doses in the
 

first little table there. That says absorbed
 

dose in centigray. And since there was one
 

exposure, it gives you the percentiles of the
 

actual exposure distribution given that level of
 

uncertainty in the exposure.
 

Then there's a factor for the quality factor
 

or relative biological effectiveness factor,
 

which was used because this is a high-LET alpha
 

exposure. And so you can see the range of
 

uncertainty that's in that factor.
 

And then thirdly, there's the excess
 

relative risk, which is derived from the
 

epidemiologic models, and you see that there's
 

quite a bit of uncertainty associated with those
 

as well.
 

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174 

Then you can go to two different pie charts
 

which show the different components of the
 

probability of causation calculation and the
 

various contribution of different sources. So in
 

the first pie chart all the uncertainty comes
 

from the excess relative risk for sources other
 

than radon, since we only had a non-radon
 

exposure here. And then the second chart shows —
 

breaks down that particular excess relative risk
 

uncertainty into various factors.
 

One of them is the organ dose. And we've
 

seen, because the geometric standard deviation is
 

five, that that's the majority of the
 

uncertainty, is contributed from that organ dose.
 

There's a smaller amount of uncertainty
 

contributed by the uncertainty in RBE, and then a
 

fairly high amount is due to the risk
 

coefficients from the epidemiologic models.
 

And Russ, I think there's another one down
 

below that, isn't there? Or is that the last
 

one? Scroll down — yeah.
 

Then the last pie chart takes that adjusted
 

ERR per sievert, since that has many adjustments
 

in it. The original ERR per sievert is the
 

uncertainty derived from the risk coefficients in
 

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175 

the atomic bomb survivor analysis. The second
 

one is errors in dosimetry for that group, the A-


bomb survivors. Thirdly, there's uncertainty in
 

how those risks should be transferred to the U.S.
 

population, but again that's a pretty small
 

contribution. There's a fairly hefty chunk from
 

the DDREF, the dose and dose-rate effectiveness
 

factor; and then an adjustment for smoking.
 

So this kind of bears out the observation,
 

which was that adjustment for smoking had a
 

relatively smaller impact on the uncertainty than
 

the change in the dose value for this model.
 

MR. HENSHAW: Thanks, Mary.
 

Before we — oops.
 

DR. ZIEMER: I think we lost it.
 

MR. HENSHAW: I clicked on the wrong thing
 

there.
 

DR. ZIEMER: I think you lost it.
 

MR. HENSHAW: Can you get that back up,
 

Larry? Do we have time for that, or —
 

Well, as it turns out we do have time to
 

actually negotiate — navigate through the screen.
 

So we're on the OCAS home page. We click on
 

PROBABILITY OF CAUSATION, click on NIOSH-IREP,
 

and on the link to the software.
 

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176 

One thing I do want to do before we get out
 

of the lung cancer scenario, if we recall the
 

very first scenario we ran, we used an exposure
 

of 20 rems. I just want to show you what happens
 

when we change that to 30 rems. If you recall
 

the result in the first case was 43 percent.
 

Change that to 30 —
 

DR. ZIEMER: I think you need alpha there,
 

though. You had electrons for exposure. That's
 

going to make it —
 

MR. HENSHAW: Oh, thank you.
 

UNIDENTIFIED: Russ, exposure year, was that
 

1981?
 

MR. HENSHAW: '81, right. Thanks.
 

By upping the dose in rem from 20 to 30,
 

you'll see that we go from a probability of
 

causation of 43 percent to 53 percent. So that
 

upping the rem dose would make this claim
 

compensable.
 

How are we doing with time? Should I
 

continue with —
 

DR. ANDERSON: Can you do an age, an older
 

person? I mean, a 40-year-old non-smoking lung
 

cancer is pretty rare. Change the birth year to
 

1925.
 

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177 

MR. HENSHAW: Leave the other factors the
 

same?
 

DR. ANDERSON: Sure.
 

MR. HENSHAW: There's no change.
 

Any other scenarios anyone would like to
 

see, or should I —
 

DR. ZIEMER: Go ahead, Rich.
 

MR. ESPINOSA: On the other screen you've
 

got exposure information, and you've got the
 

factor of one in there. What is — is one a onetime exposure? Is one lifelong history as a DOE
 

employee? What does that one stand for? Right
 

there on exposure information.
 

UNIDENTIFIED: The number of exposures.
 

MR. HENSHAW: Oh, right here?
 

MR. ESPINOSA: Yeah.
 

MR. HENSHAW: Okay. Yeah, we're using in
 

this case one exposure in the year 1981. If the
 

person, say, worked in a facility, had exposures
 

in a number of different years, there would be a
 

separate exposure for each year.
 

DR. NETON: Those are effectively exposure
 

years, your annual exposure for a particular
 

radiation type. So for instance, if you had an
 

exposure to alpha concomitant with exposure to
 

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178 

gamma, you would have two blocks for 1981, one
 

for the alpha component, that annual component,
 

and one for the gamma component.
 

MS. NEWSOM: What's your name, sir?
 

DR. NETON: Jim Neton.
 

MS. NEWSOM: Thank you.
 

MR. HENSHAW: Larry, we're kind of running
 

out of time for Mary's presentation. Should I —
 

DR. ZIEMER: Yeah, I think that's probably
 

enough examples. We need to move ahead.
 

Is that agreeable? Do we need to vote on
 

that?
 

[Laughter]
 

MR. ELLIOTT: We're all conflicted.
 

DR. ZIEMER: By consensus, we're going to
 

move ahead.
 

DR. SCHUBAUER-BERIGAN: Okay, in the
 

remaining ten minutes or so for the schedule, I
 

wanted to talk about some of the special issues
 

in running the IREP software for EEOICPA. And
 

some of these we've already talked to you about
 

earlier, but I wanted to just illustrate how this
 

would be done in practice.
 

One of the situations is claims for which
 

more than one IREP run must be conducted. Russ
 

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179 

has gone over the example of two or more primary
 

cancers and how that would be treated. I also
 

wanted to illustrate the effects of age at
 

exposure on leukemia and specific leukemia
 

subtype PC estimation, and then one final example
 

of a metastasized cancer with an unknown primary
 

site.
 

I wanted to briefly cover the issue of
 

specifying the exposure type, acute versus
 

chronic, when that's unknown, and how that's
 

handled. And also just briefly touch on the
 

issues of effects of gender, ethnicity and age at
 

exposure on the PC estimate.
 

This shows an example scenario, a male
 

exposed in one year to five rem who was diagnosed
 

with acute myeloid leukemia 17 years later. For
 

AML there is no adjustment for age at exposure.
 

However, for the general leukemia model within
 

IREP there is an adjustment for age at exposure.
 

Since there is uncertainty about which factor —
 

i.e., the leukemia subtype or age at exposure —
 

is more important to adjust for, we've taken one
 

of the steps that Ted referred to from a policy
 

standpoint, which is to give in the face of these
 

types of unknowns to give the benefit of the
 

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180 

doubt to the claimant.
 

In this particular example, the highest
 

probability of causation produced by each model
 

that's run would then be used by DOL to
 

adjudicate that claim. So for this example, for
 

someone exposed at age 23, the general leukemia
 

model produces a higher PC estimate. And for the
 

same person exposed at age 43, the type-specific
 

model produces the higher estimate. So in this
 

case both would be calculated, and the value
 

giving the highest PC estimate would be actually
 

used.
 

This is a similar type of pattern for
 

chronic myeloid leukemia, and again the same
 

process and the same outcome for this specific
 

example would be used.
 

Just to illustrate what would happen when
 

you have a secondary cancer with an unknown
 

primary site, the example claimant is a white
 

Hispanic man — and it's important to illustrate
 

that you've got to actually collect ethnicity and
 

smoking histories for secondary cancers with
 

unknown primary site, because frequently you'll
 

need to calculate the PC value for lung cancer
 

and skin cancer.
 

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181 

In this case we, as I said, developed lists
 

of likely primary sites based on NCHS data, and
 

these are tabulated in 42 CFR Part 81, Table 1.
 

For lung cancer in men, the list of likely
 

primary sites includes the ones that you see here
 

— colon cancer, lung cancer, malignant melanoma
 

of the skin, prostate, bladder and kidney cancer.
 

So because of this uncertainty, Department of
 

Labor would calculate the PC value for each of
 

these likely primary sites, and the site
 

producing the highest probability of causation
 

estimate would be used to adjudicate the claim,
 

in this case malignant melanoma.
 

For the same cancer, and mostly the same
 

conditions — this is woman this time — her
 

secondary lung cancer produces a different list
 

of likely primary sites. And of the four, the
 

lung cancer estimate produces the highest PC
 

value, and then would thus be used in
 

adjudicating the claim.
 

All right. This slide illustrates a couple
 

of different things that are, I think, of
 

interest. First, it shows how the probability of
 

causation estimates could — can differ by gender,
 

by exposure, and by cancer site. Under the same
 

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182 

exposure conditions, for many cancers the
 

probability of causation estimates tend to be
 

higher for females than for males. And in large
 

part this is due to the finding of increased risk
 

per unit dose among women.
 

Just as an example, the lung cancers are
 

shown in red on this slide, and the results for
 

females are shown in squares and the results for
 

males in triangles. So you can see that the
 

female lung, and then in blue the pancreas
 

cancer, probability of causation estimates are
 

higher for females. And here for males, the
 

dose producing a probability of causation of 50
 

percent at the upper 99th percentile estimate is
 

about ten rem, and for females it was lower than
 

that, at about six rem for lung cancer. And for
 

pancreatic cancer the same tendency is found, and
 

for males the dose is about 30 rem and for
 

females it's about ten rem. And this slide also
 

shows you that the risk values for each sex are
 

greater for lung cancer than they are for
 

pancreatic cancer, at least for a non-smoker, a
 

never-smoker.
 

Lastly, I wanted to say a few words about
 

acute versus chronic exposure, and I don't have a
 

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183 

slide for this, unfortunately. For most DOE
 

workers within a given badging period, it'll be
 

unknown to us whether the dose received in that
 

period was received as an acute or a chronic
 

dose. All we might have is their recollection of
 

what they were working at, what they were doing,
 

and what the badges say.
 

Because for most radiation types there's a
 

dose-rate reduction factor applied, assuming that
 

the dose was chronic tends to lead to a lower
 

estimate of probability of causation than by
 

assuming that the dose was received in an acute
 

basis. Since this cannot be known from the
 

available data, again, give the benefit of the
 

doubt to the claimants and use the assumption
 

producing the highest probability of causation
 

estimate.
 

I think that puts us at about a quarter
 

till, but I have time for a few questions, at
 

least.
 

DR. ZIEMER: I have a question on that, on
 

the last item. As I understand it, what's being
 

done on the acute versus chronic is to apply a
 

dose-rate factor to the Japanese data.
 

DR. SCHUBAUER-BERIGAN: Yes.
 

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184 

DR. ZIEMER: Now acute in terms of the
 

Japanese exposures is an exposure in, what,
 

microseconds or something like that.
 

DR. SCHUBAUER-BERIGAN: Uh-huh
 

(affirmative).
 

DR. ZIEMER: I think one would be hard-


pressed to find any occupational exposures where
 

the total doses were, outside of accident
 

situations, where you could really argue that we
 

come anywhere close to the acute dose rates in
 

Japan.
 

DR. SCHUBAUER-BERIGAN: Well —
 

DR. ZIEMER: So what is meant by acute here?
 

And I guess I'm raising the question as to
 

whether one really should apply such a factor for
 

those cases.
 

DR. SCHUBAUER-BERIGAN: The justification
 

for use of a dose-rate reduction factor, in my
 

opinion, doesn't stem really from the Japanese
 

atomic bomb survivor data.
 

DR. ZIEMER: Oh, it doesn't? I see.
 

DR. SCHUBAUER-BERIGAN: In fact, the most
 

recent analyses of that cohort show that the risk
 

per unit dose is about essentially the same,
 

regardless of the dose. There's no — for total
 

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185 

solid cancers there doesn't appear to be
 

attenuation of risk at these very low doses. But
 

there's a body of evidence from many other types
 

of studies that supports this. So in defining
 

what is an acute versus a chronic dose, I don't
 

necessarily think that you have to compare the
 

Japanese exposure scenario to a DOE worker.
 

This topic did come up in a NAS review panel
 

of the NCI model, and I believe that the
 

operating definition that was suggested was
 

something on the order of hours to be considered
 

an acute dose. Charles can correct me if that
 

recollection is incorrect.
 

DR. ZIEMER: Is this based on epi data or on
 

in vitro or cell data, or do we know? Anybody
 

know?
 

DR. SCHUBAUER-BERIGAN: It's, I would guess,
 

based on an amalgam of many different types of
 

studies, and there's been many committees
 

established to evaluate dose-rate effectiveness
 

factors. We're most concerned about the
 

operating definition that should be used in this
 

application. And if we're talking the order of
 

hours or days to define an acute dose, then I
 

think we have probably a greater need to allow
 

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186 

for —
 

DR. ZIEMER: Yeah, I was looking for
 

clarification. I think it's certainly
 

appropriate, if you have a — let's say a film
 

badge or a TLD badge where you have some reading
 

and you know the person's worn that badge for 30
 

days, it would be prudent to assume they got the
 

dose all on the first day or something. So it's
 

acute in the sense that it's within, say, eight
 

hours or some lesser number of hours, maybe one
 

hour, but — is that what we're talking about by
 

acute here in this case?
 

DR. SCHUBAUER-BERIGAN: Yes.
 

DR. ZIEMER: Okay.
 

MR. ELLIOTT: We know of criticality
 

incidents like 1958 at Y12 where several
 

individuals were exposed, and that would be one
 

we would count as an acute event. Am I correct?
 

DR. SCHUBAUER-BERIGAN: Yes. Yes, and
 

here's — there's also an example of —
 

UNIDENTIFIED: (Inaudible)
 

DR. SCHUBAUER-BERIGAN: Well, an opposite
 

type of example would be an alpha — a plutonium
 

exposure to bone, where it's well known that you
 

received that exposure, and then you get these
 

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tissues irradiated over — on a chronic basis
 

throughout the life of the individual. So that
 

would be a clear example where we know it's a
 

chronic type of exposure, and then that would be
 

used.
 

DR. ANDERSON: That was my question in the
 

program there. When would chronic be chosen?
 

DR. SCHUBAUER-BERIGAN: Chronic would be —
 

DR. ANDERSON: Would it be related to
 

certain elements, what types of exposure, or —
 

DR. SCHUBAUER-BERIGAN: It would absolutely
 

be related to type of exposure. And in most
 

cases — and Jim and some of the other health
 

physicists can speak to this — but I think in
 

most cases an alpha exposure would be considered
 

a chronic exposure.
 

DR. NETON: There's really no plausible
 

alpha exposure that we could come up with that
 

would be considered an acute case with possible
 

exception of radon daughters, but that's handled
 

in a whole separate risk model. It's not covered
 

under this model.
 

DR. SCHUBAUER-BERIGAN: There's another
 

example of where we might call it a chronic dose,
 

and that is neutron exposure.
 

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DR. ANDERSON: Right.
 

DR. SCHUBAUER-BERIGAN: There is the
 

incorporation of an inverse dose-rate
 

effectiveness factor for neutrons as a high-LET
 

emitter.
 

DR. NETON: This is something we're
 

wrestling with, because you could have the same
 

film badge, record the same exposure, and in one
 

case you'd be forced into calling neutrons
 

chronic and gamma acute. And so it's a policy
 

issue that we have to deal with.
 

DR. SCHUBAUER-BERIGAN: Right.
 

DR. ANDERSON: I was only asking as it
 

relates to an individual getting on your web page
 

and trying to do their own profile versus yours
 

that you would do for adjudicating a claim. You
 

know, they might get the wrong — if this allows
 

them to use acute when in fact it's chronic, you
 

may —
 

DR. SCHUBAUER-BERIGAN: Right. Well, that —
 

DR. ANDERSON: — want to program it such
 

that it doesn't allow you to do that if it's
 

almost always one or the other.
 

DR. SCHUBAUER-BERIGAN: Yeah, that's one of
 

the dangers of making the program publicly
 

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available, is that there's — until the dose
 

reconstruction is complete and the rule is
 

finalized, there is no way for a claimant to
 

guarantee that when they do their own probability
 

of causation calculation that it would be the
 

same as the one that DOL will eventually compute
 

for them. And that's just one of the many
 

factors that weights, plays a part of that.
 

DR. ZIEMER: Are there any further questions
 

at this time?
 

[No responses]
 

DR. ZIEMER: If not, let's proceed then to
 

the next item, which is the dose reconstruction
 

rule, 42 CFR 82, and back to Ted Katz, I believe.
 

Ted.
 

MR. KATZ: Thank you, Mary.
 

Hello again. Okay, I'm going to do more or
 

less the same as what I did for or against Mary,
 

which is to start the ball rolling for Jim,
 

who'll give you more technical background. But
 

I'm going to give you background on it and a
 

general, very brief overview on the dose
 

reconstruction methods which, as we've talked
 

about, are already effective.
 

So here's my overview here. I'm going to
 

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discuss what the purpose of these methods is, how
 

they'll be used, what Congress requires with
 

respect to these methods. I'm going to give you
 

some basics of dose reconstruction under the
 

interim rule. And then two issues, one a very
 

core issue, which I say here, how NIOSH will
 

balance efficiency and precision. And then a
 

sort of extreme case that we address in the rule
 

too, which is what happens when NIOSH cannot
 

complete a dose reconstruction.
 

So the purpose of the methods is to
 

establish how NIOSH will estimate radiation doses
 

incurred by employees. Each employee needs dose
 

estimates to be able to have a probability of
 

causation determined, and the dose estimates will
 

be used by DOL to determine that cause.
 

NIOSH, I make this point, will make — will
 

conduct dose reconstructions for cancer claimants
 

only. This is important. These dose
 

reconstructions are entirely designed for making
 

compensation decisions, and you wouldn't design
 

them the same way if you were doing research.
 

And it ends up being very important, but we don't
 

have, in the case of a claimant, years to decide
 

how much dose they were exposed, in effect.
 

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What does Congress require here? First, it
 

requires that the methods must be applied for
 

employees, and it specifies not monitored,
 

monitored inadequately, and with incomplete
 

records.
 

Now in practical terms, it means the methods
 

will be applied for all claims, and let me
 

qualify that here. Someone has to determine
 

whether they were monitored adequately or not and
 

whether they had complete records and so on. So
 

these are going to have to come to NIOSH to have
 

a look, at the very least. And then the extent
 

to which a dose reconstruction is done is
 

determined on a case-by-case basis, depending on
 

what you have there. But we will have to handle
 

the cases for all the claims. And the Board has
 

a very important role which has been discussed,
 

which is to independently review the methods and
 

a sample of dose reconstructions.
 

What are the basics? We talk about this in
 

the rule. We rely on a hierarchy of data that
 

starts with personal monitoring data and extends
 

to monitoring process and source information.
 

The key issue, as I say here, is the
 

completeness and adequacy of the data. And what
 

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this requires, then, is that we address all
 

sources of data. So the hierarchy, it's a little
 

bit misleading for some in reading this rule,
 

perhaps, thinking that we're just then using the
 

monitoring data if there's monitoring data there.
 

But no, in fact we're going to have to look at
 

these other sources of data to interpret that
 

monitoring data.
 

And a key element of this, as has been
 

discussed earlier, is we're going to be
 

interviewing the employees to identify and fill
 

data gaps and help interpret the data. The
 

employees can tell us about actual monitoring
 

practices, perhaps, versus official practices.
 

They can tell us about incidents that occurred
 

that may not show in their record, and so on.
 

And it's important to note here that we're
 

dealing with a lot of claims that are going to be
 

coming as well from survivors, and the survivors
 

typically know very little about what their
 

spouse did. And this is why in those cases we'll
 

be going to coworkers as a surrogate for the
 

deceased spouse.
 

To continue on here, Jim Neton's going to
 

really go into detail about this next point.
 

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We’re going to make the use of the best science,
 

ICRP models and a state-of-the-art internal
 

dosimetry program.
 

Very importantly, we're going to provide
 

full accounting to the claimant of the methods,
 

data, assumptions used. They will have, at the
 

end of the process, a report that accounts for
 

all the information they provided, for all the
 

information we obtained from DOE, and for all we
 

did with that information. So they will be fully
 

informed. They can take that information and not
 

have to flay us for more information to
 

understand what happened in the process.
 

And also importantly, the claimant's going
 

to be very involved with us in doing the dose
 

reconstruction. But at the end of it all, if
 

they are dissatisfied, if they have reason, they
 

have cause to think that we haven't applied our
 

methods appropriately, they can seek review
 

through DOL.
 

Now this is what I mentioned as a really
 

core issue, which is I think unique to our
 

program here, how NIOSH will balance precision
 

and efficiency. And you see this first bullet is
 

already outdated after a couple of weeks, because
 

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I say 12,000 claims and they already have at DOL
 

15,000 claims that are coming our way —
 

incredible, unprecedented volume that we're
 

dealing with of dose reconstruction here. And it
 

doesn't allow us to do dose reconstructions, as
 

we've said, if we're going to provide timely
 

service the way we would for research. And
 

Congress emphasized the need for timeliness, and
 

it's obvious for the human need here. I’m going
 

to remind everyone we're doing dose
 

reconstruction to permit claim decisions, not
 

achieve precision here.
 

So the basic strategy here to get to that
 

point, to be able to do this while ensuring
 

fairness, is to shortcut the process, in effect,
 

for two groups.
 

For groups with very high doses what we're
 

going to do is curtail data collection and
 

analysis. There's no point delaying their
 

compensation for us to develop a more precise,
 

complete dose reconstruction record. So we're
 

going to move those claims as quickly as
 

possible, and they'll have their compensation
 

sooner.
 

And then the other extreme is employees with
 

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very low doses. Once we've collected enough
 

information to know that, including speaking with
 

the claimant or coworker and so on, is to use
 

worst-case assumptions so that there's no doubt
 

for the claimant that their dose hasn't reached a
 

compensability level.
 

And then for all those claims that fall in
 

the gray area which aren't obviously extremely
 

high or extremely low, we will proceed with the
 

full process.
 

Last issue, what happens when NIOSH cannot
 

complete a dose reconstruction? Now we don't
 

have a good feel, I don't think, at this point
 

for how common this fix will be. But it's clear
 

to us that it's going to be relatively rare, I
 

think. And it's going to be situations where we
 

have very little information about source and
 

process.
 

Anyway, this situation has been anticipated
 

by EEOICPA, by Congress, which allows for SEC
 

petitions, petitions to be added to the Special
 

Exposure Cohort. And several people talked
 

earlier that HHS is responsible for these
 

procedures and these are in the works. And
 

you'll be hearing about these in future meetings.
 

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And the last point I want to make here about
 

these is while this is a remedy for most, there
 

may be individuals who we can't do a dose
 

reconstruction for who have — don't have a cancer
 

on the specified cancer list. And in their
 

situation this isn't a remedy. This is not an
 

avenue for compensation.
 

Thank you. And would you like me to take
 

questions, or wait for Jim?
 

DR. ZIEMER: Well, let's see if there are
 

questions at this moment.
 

Yes, Dr. Roessler?
 

DR. ROESSLER: When you talk about the
 

shortcut process and the very low doses, what's
 

your definition of a very low dose? I mean, is
 

there a number that you use that puts them in
 

that —
 

MR. KATZ: There is — no, there isn't a
 

number, because low dose depends on what type of
 

cancer and a number of parameters. But given the
 

volume of experience that's going to be gained
 

very quickly here, we'll learn what it means in
 

different situations. And so there's no — we
 

couldn't say — we couldn't put out one number
 

that's going to work for all these cancers, for
 

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all these exposure situations, and so on. But
 

it'll be cases where it's evident that the dose
 

is far too low to be compensable, again in the
 

judgment of the experts who are going to be
 

running all this work.
 

Any more questions?
 

[No responses]
 

DR. ZIEMER: Okay. We'll proceed, then,
 

with —
 

MR. KATZ: Thank you.
 

DR. ZIEMER: — Dr. Neton, who will give
 

additional information on dose reconstruction.
 

DR. NETON: Good afternoon. It's a pleasure
 

to be here and finally address the Board, after
 

it seems like an eternity of waiting for your
 

arrival. I appreciate your input on any of the
 

information that we're talking about today.
 

In particular I should point out that what
 

I'm going to discuss is draft. No final
 

decisions have been made by our office on these
 

technical issues. These are just some of the
 

ideas that we're sharing at this time.
 

I am Jim Neton, and I'm the Health Science
 

Administrator within the Office of Compensation
 

Analysis and Support. And I've got the
 

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challenging effort of trying to process these
 

tens of thousands of claims with a staff of some
 

very qualified people — health physicists and
 

claims processors — to try to make some sense as
 

to how we're going to approach this and do this
 

in a timely manner to award claims, hopefully not
 

in glacial time but in — not in real time,
 

either, but to make it as efficient and fair a
 

process as possible.
 

Now the first thing I think it's important
 

to talk about is the difference between
 

compensation dose and regulatory dose. We've
 

hinted about this all afternoon in going through
 

the probability of causation estimates and such,
 

but there are a number of key differences between
 

what a compliance program in the field that the
 

DOE ran for years to try to ensure their workers
 

were adequately protected, versus what we need to
 

know to determine if the probability of
 

compensation is equal to or greater than 50
 

percent.
 

The first issue is the compensation dose
 

evaluation period is not limited, or is limited
 

only to covered employment. For example, we're
 

not interested in lifetime monitoring dose, which
 

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many DOE sites have a fairly good handle on, but
 

that's not relevant. And in fact, we need to
 

know something more than that. We need to know
 

the person's dose from the date of first exposure
 

of covered employment to the date of the
 

diagnosis of cancer. That's the only period that
 

we're really concerned about that will be
 

actually input in the probability of causation
 

calculation. So in that respect we need to pull
 

a lot of monitoring records through, sift through
 

them, and pull out that unique time frame.
 

The other issue is that it includes
 

internal, external and some occupationally-


acquired medical sources of exposure. Those of
 

you who have done health physics work in the DOE
 

are aware that prior to the late eighties, like I
 

think 1/1/89 comes to mind, internal doses were
 

not really calculated at DOE facilities. They
 

were — workers were protected based on what they
 

called the maximum permissible body burden
 

concept, which was dosimetrically based, but does
 

not provide the type of information that we would
 

need for a compensation scheme.
 

In addition, this occupationally-acquired
 

medical sources of exposures is unique to our
 

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process as well. And what we mean by that is
 

medical exposures that were incurred by a worker
 

as a condition of employment. For example, there
 

are some sites where to be, in the earlier days,
 

to be qualified as an asbestos worker, you were
 

required to undergo an annual chest X-ray. It
 

was required for you to do your job. In our
 

opinion, therefore, that is occupationally-


derived exposure that should be included in his
 

compensability examination. Routine physical
 

examinations, if they were voluntary, that sort
 

of thing, would not be included under this.
 

And it's probably pretty obvious after going
 

through the probability of causation examples
 

that Russ and Mary did that an annual dose is
 

required for a probability of causation estimate.
 

We cannot use the 50-year committed dose
 

equivalent or committed effective dose equivalent
 

that is currently applied to Department of Energy
 

workers.
 

And I know some sites have actually gone
 

back and done sort of pseudo dose reconstruction
 

efforts and calculated a worker's 50-year
 

committed dose from earlier years of employment.
 

That information would be useful for us, but not
 

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necessarily in that form. We still are going to
 

have to pull out the annual dose, because as you
 

saw earlier, the probability of causation changes
 

depending upon the distribution, annual
 

distribution profile of that worker's exposure.
 

On a similar note, the committed effective
 

dose equivalent concept, as I mentioned, is not
 

applicable. The 50-year dose that's calculated
 

to a worker from an internal exposure is not
 

something useful for us, nor is the effective
 

component of that. The effective dose component
 

of that calculation is really a risk-based unit.
 

I mean, it’s taking a radiation exposure and
 

trying to equate it to a risk to protect the
 

worker. We need to strip the effective component
 

out, and as you saw earlier, IREP actually does,
 

has the risk model built into it.
 

So in a sense, what we are ending up with
 

with our calculations is a dose equivalent, the
 

old Hp, H=DQN type thing, dose times a quality
 

factor times other modifying factors. And that
 

is in fact what we need to calculate.
 

Okay. Continuing on with some of the
 

differences, at least as I see them, for external
 

exposures the film badges and TLD badges have
 

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been used historically since virtually the
 

inception of DOE operations. But what that does
 

is that measures the dose to the badge. In the
 

earlier years it measured the dose to the badge.
 

Under current regulatory framework, you actually
 

measure the dose — you try to estimate the dose
 

at one centimeter deep in the body, and we'll
 

call that deep dose.
 

Well, that may or may not be applicable to a
 

worker's compensation analysis. For example,
 

organs that are very deep in the body, such as,
 

you know, the liver or a lung, which is covered
 

by five centimeters of overlying chest tissue,
 

may be lower than the badge reading that the
 

worker received.
 

Now for most scenarios — and I'm going to
 

talk about this in some detail tomorrow — it's
 

pretty close for high energy photons. The
 

situation where you get into very low energy
 

exposures, such as from americium-241, 60-keV
 

gammas or plutonium X-rays, there can be massive
 

differences between the recorded badge dose and
 

the actual dose delivered to the organ. And we
 

need to take a look at that and bring some sanity
 

to that calculation.
 

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A very important point is that undetected
 

dose, also known in the business as missed dose,
 

is an important factor. In a regulatory
 

framework one is interested, particularly in the
 

earlier years, of maintaining employees’ exposure
 

below some regulatory limit, and the monitoring
 

programs could have a fair amount of dose that
 

was undetected and still be considered adequately
 

protective of the worker. We need to take that
 

into account when reconstructing the worker's
 

exposure.
 

I'm going to go over a couple of little
 

examples of that later on, but the classic
 

example is the film badge has a certain detection
 

limit. In the earlier years it could have been
 

as high as 30 millirem received on a weekly basis
 

by an employee. And if that badge was exchanged,
 

like I said, every week, then there's a potential
 

— I'm not saying it was received — but a
 

potential for the worker to receive upwards of
 

one and a half rem of exposure and had gone
 

undetected. So we are developing ways of dealing
 

with that in our guidelines.
 

Another factor is uncertainty distributions
 

are allowed. In the compliance-based world
 

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they're point estimates. I've never seen any
 

errors associated, unless maybe some massive dose
 

reconstruction for some really big incident like
 

a criticality, errors are not typically assigned
 

because they're below the limit, and that's fine.
 

We have the opportunity here to characterize
 

these uncertainty distributions for each worker.
 

We’ve demonstrated earlier with IREP as to
 

what the change in the standard deviation of that
 

estimate can do to the probability of causation.
 

We're taking a long, hard look at how we actually
 

apply those, particularly in the area of internal
 

dose where geometric standard deviations — well,
 

if it's lognormal distributed, a gSD of two or
 

three is probably not unheard of.
 

And the other, one of the nice features that
 

we have available to us, is we're not constrained
 

by regulatory-required science. All the current
 

standards — the Department of Energy right now is
 

based on the old ICRP 30, 26 dose limitation
 

philosophy, which is fine. But there are more
 

current and appropriate models out there that we
 

feel are better science and do a better job at
 

estimating the actual dose to the organ. And
 

we'll talk a little bit about that.
 

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Okay, a technical approach. The first thing
 

we need to do is to take a look at all doses of
 

record and evaluate them for data quality
 

shortcomings. We are not going to accept even
 

personnel monitoring data at face value and
 

assume that it's adequate. I mentioned in the
 

earlier days at some facilities there were
 

plutonium exposures that — it's well known that
 

the badge was not capable of detecting those low
 

energy X-rays, so those were unrecorded. We need
 

to make some adjustments to those data as we
 

develop our knowledge base of the technology at
 

the different sites.
 

As I talked about, we're going to assess the
 

capability of external programs over time, look
 

at the badges, their response to neutrons, gamma,
 

X, and in particular the radiochemical techniques
 

for bioassay sampling needs to be taken a look
 

at. In the early days some of the radiochemical
 

processes, although they were good, were —
 

tracers weren't necessarily used all the time, so
 

one does not really know about the chemical
 

recovery of the method that was used, different
 

issues like that; the efficiency of the alpha
 

proportional counters that were used. We're
 

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going to take a look at all those types of
 

information.
 

I talked about earlier looking for the
 

potential for undetected dose. And for external
 

exposures we've concluded that we're going to use
 

— and I'll talk in much more detail tomorrow if
 

there's time — about what they call the limit of
 

detection divided by two. If a badge could read
 

30 millirem, there are a number of papers out
 

there — Hornung, et al. and others — have
 

suggested that the detection limit divided by two
 

is an appropriate metric to estimate the central
 

tendency estimate of that exposure for that
 

monitoring period. But it's a little more
 

complicated than that, whether it's a lognormal
 

or normal distribution. We can talk about that
 

tomorrow.
 

And a parallel note, the minimum detectible
 

internal dose is even more complicated because
 

bioassay monitoring programs have a certain
 

detection limit, but depending on how frequently
 

a sample is collected for a worker, the dose
 

could be — is quite — the undetected dose is
 

quite variable. It's sort of intuitive that if
 

one takes a sample on an annual basis, the worker
 

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could have received a lot more dose and been
 

undetected than if a sample is taken on a weekly
 

basis or a daily basis. So we're taking a long
 

hard look at that as well.
 

I talked about using these ICRP — Internal
 

Commission on Radiological Protection — models.
 

In particular we are embracing the ICRP 66 lung
 

model for our dose calculation efforts. We have
 

a contractor, ACJ & Associates, has developed a
 

program for us. It's a beta version at this
 

point. It's called IMBA, Integrated Modules for
 

Bioassay Analysis, and that's what we're going to
 

be applying.
 

We also believe that some of the more recent
 

ICRP models take advantage of recycling of
 

material in the body. The old ICRP 30 models are
 

sort of what comes in one end goes out the other,
 

and it never mixes back in the blood pool, that
 

sort of thing. These new plutonium models allow
 

for that type of analyses. So we feel it's a
 

better representation of the biology.
 

In the external dosimetry evaluation the
 

ICRP 74 model, ICRP 74, we're going to use to do
 

those evaluations. And again I can talk in some
 

more detail about that, but it takes into account
 

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effects of conversion of the badge dose to what
 

the organ actually received; also evaluation of
 

the effect of the geometry of exposure.
 

For instance, if a person wears a badge on
 

the front of their chest and is exposed in
 

isometric fashion, then the badge that's
 

calibrated from a beam impinging directly on the
 

body is not necessarily calibrated properly.
 

We're evaluating all those various factors and
 

trying to incorporate that uncertainty into the
 

overall analysis.
 

Ted touched on this earlier, but we do —
 

once we evaluate the quality of the data, we do
 

preferentially want — will use individual
 

monitoring data if it appears to be adequate.
 

And that makes sense. It was the actual — the
 

person's own monitoring information at that time
 

at that place, and that's where we intend to
 

start if it's available.
 

As that information becomes less and less
 

available, we'll have to back off and go to other
 

strategies, and that would — the hierarchy goes
 

area dosimeters, radiation surveys, air sampling,
 

those type of things, what I consider work place
 

monitoring data. And then as Ted alluded to, if
 

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there's nothing out there, we can use a source
 

term to evaluate that information. And
 

surprisingly, source term information can do a —
 

go a long way towards bracketing a worker's
 

potential exposure.
 

I always use the example, you know, did a
 

worker — when you're interviewing a claimant, did
 

you work with grams, kilograms or tons of this
 

material, and was it in dispersable form or was
 

it contained in a rod. With those kind of
 

bracketing assumptions — I have an example
 

tomorrow — it's possible to put some — an
 

estimate of central tendency, and put some
 

confidence limits about that information.
 

These are just — this is sort of what I
 

consider to be the universe of information types.
 

This is in the rule, in 82. It's not all-


inclusive. Some folks have pointed out there's a
 

few items that probably could be included on
 

there. For instance, continuous air monitor data
 

is not in there. But I think it's a pretty good
 

list, and gives us an idea of what types of
 

information we would use.
 

Now I'm not suggesting that we're going to
 

use all of this information on every claim. That
 

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seems to be a common misconception out there.
 

What it really says is, you know, if we can't —
 

if we can find some of this stuff, we'll use it.
 

And we need to get out there and verify, is some
 

of this information out there? And not only is
 

it there, but is it in usable form, readily
 

available for us to apply to a compensation
 

program in the near term?
 

It does us no good if there are air sampling
 

results distributed over 50 facilities, paper
 

copies in offices. It would take us three to
 

five years to data-capture and code. So we need
 

to go out there and do what I call a dosimetry
 

information resource evaluation to determine how
 

much we're going to use this information. I
 

think we owe it to the claimants, though, to at
 

least uncover all these stones and determine why
 

we did not use this — these types of information.
 

Okay. Talk about processing strategy. I'm
 

going to try to give you a little example of how
 

this might work. We're going to start
 

conservatively, using simple available monitoring
 

data. And for example, let's take the case where
 

have adequate either bioassay or TLD information,
 

and we determine it to be of adequate quality.
 

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Perform an initial evaluation using extremely
 

worst-case assumptions in some cases, and if it
 

looks like the probability of causation's going
 

to be low, we're done.
 

Now the question was raised, well, what's
 

the number? We really have no number at this
 

point. We're in the process of constructing
 

tables that you can kind of run through. If you
 

can automate your IREP inputs, you can do
 

continuous runs of IREP and generate tables of
 

distributions of doses that can bracket certain
 

scenarios. You can take a cancer type and an
 

optimum, say, exposure scenario — optimum
 

exposure condition set for a cancer and try to
 

get an idea on this. But we're still working on
 

really what these cut points are going to be.
 

Here's a flow diagram. It looks somewhat
 

complicated, but it's really quite simple. Let's
 

just take through one example. For instance, the
 

top box, if you take the top box here, determine
 

the organ of interest and most probable mode of
 

exposure. What we're saying there is this is
 

where a health physicist has to apply some degree
 

of professional judgment.
 

If a person worked at a uranium facility, I
 

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think it would be fairly well agreed upon that
 

uranium and internal exposure would be the most
 

likely high source of exposure. Uranium
 

facilities, at least not enriched ones, are
 

fairly low in the gamma component. If you took
 

the ratio of internal to external, internal would
 

always have a higher potential.
 

So if one went through and first picked and
 

said, okay, I'm going to go through and do an
 

internal dose calculation for this person using
 

worst-case assumptions, and I go through and it's
 

a low probability — and by worst case, I mean
 

very insoluble material, worst-case missed dose,
 

minimum detectible dose — if it's a low
 

probability, we still need to consider what his
 

external exposure was. So we would go through
 

and use worst-case assumptions for his external
 

exposure, accounting for all that missed dose
 

based on badge exchanges, et cetera. If it's
 

still a low probability, then there's no way that
 

this number would likely be compensable, so the
 

dose reconstruction is done. We bypassed a fair
 

amount of work.
 

I have a couple of short examples I can show
 

on this. Likewise, if it was not a low
 

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probability, say it came out very high for the
 

internal exposure based on these insoluble
 

materials, and then we went and said, okay, let's
 

do a conservatively low estimate for that
 

internal exposure as well. So we've gone high.
 

It looks like it's high. Let's figure out what
 

the lowest plausible exposure was, and if it's a
 

high probability — if it's still a high
 

probability after you've taken your least — most
 

conservative assumption, then you're done.
 

So this is a process that we've outlined,
 

and we've gone through several scenarios. And it
 

appears like it will allow us to gain a great
 

amount of efficiency in this process, where we're
 

not going to have to go through a very detailed
 

analysis for every case.
 

Here's an example — and these are some
 

fairly real-world type examples of an exposure at
 

— I believe this was Hanford. The person was
 

exposed from 1954 to 1961, had fairly low annual
 

doses for X-ray and gamma exposures. And so we
 

would go in and account for this missed dose, the
 

undetected dose, add it back in and input — not
 

input this into IREP, but use our experience base
 

from IREP and realize that this case is going to
 

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be — has a very low probability for compensation,
 

especially if there was no external component
 

available. I think when you saw — for solid
 

tumor particularly, you saw the runs that were
 

done earlier. Solid tumors with under a rem of
 

exposure, whatever that amounts to, are very,
 

very low probability of compensation.
 

On the other hand, we would take something
 

like this plutonium bioassay data, and this is
 

urine concentration of plutonium at picocuries
 

per liter. The dates aren't really relevant, but
 

say that this was over a several-year time span.
 

The detection limit for this fellow was .05
 

picocuries per liter, so that's right around in
 

here. And you can see that he's had a series of
 

acute intermittent exposures, which I suppose
 

could be modeled as chronic exposure.
 

But in our first worst-case assumption we're
 

going to ignore it, and we're going to say, let's
 

just look at this thing. This is a fairly large
 

exposure. Let's take these points and assume
 

that the exposure for these points occurred way
 

back here at the date of first employment.
 

So what you end up is wildly over-predicting
 

this intake, ignoring all this low stuff. And if
 

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that calculation still came out very low, then
 

you're done. You'll never have to even mess
 

around with these other 20 or 30 data points
 

because you've demonstrated that. This may be
 

the case for some very soluble material like UF4
 

that leaves a lung very quickly as opposed to
 

insoluble.
 

Conversely, say if this exposure came out
 

very high based on this, which you would expect
 

if it was insoluble, then we could go over here
 

and say, well, let's just look at this intake by
 

itself. Let's see if this intake alone is high
 

enough for the person to be compensated. We
 

still haven't had to calculate any of these data
 

points. And if we model this intake — just these
 

points right here — and the probability of
 

causation was very high, we're also done. So it
 

does a lot for us.
 

Now one thing that's not obvious until you
 

start looking at it is it really has a lot to do
 

with the organ that you're calculating the dose
 

to. For internal exposures it's somewhat self-


limiting in the fact that the only organs that
 

really get a fairly large exposure are the organs
 

that tend to concentrate the material. For
 

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plutonium that would be something like the lung,
 

the liver and the skeleton. If you have a cancer
 

for any other organ and I wildly over-estimate
 

this dose, I can pretty much bet that the dose to
 

those non — what I call source organs, is also
 

going to be low because plutonium does not
 

concentrate in the prostate or the gallbladder or
 

other organs like that. And in fact, if you run
 

through the models, it is very low.
 

We've actually had our IREP or IMBA program,
 

Integrated Modules for Bioassay internal dose
 

program, we've had them go through, and we
 

calculate a dose to each of the 36 ICRP 60 type
 

organs that are out there now, and we can see
 

these large differences. Virtually the only dose
 

you get to a non-source organ is the crossfire
 

from the organ — one organ to another. And there
 

may be some ways of looking at the transfer
 

compartment and adding a little dose back, but I
 

still suspect it's going to be low.
 

Okay. This slide is woefully out of date
 

and probably needs updating. I apologize, but I
 

guess I got lazy at the last minute. This is
 

essentially our attempt to demonstrate what an
 

input to IMBA would look like — IREP would look
 

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like when we provided it to the Department of
 

Labor. And you've seen the demonstration where
 

we have to determine what the type of
 

distribution we expect the exposure to be, and we
 

put in our best estimate of central tendency, and
 

we also insert our geometric standard deviation
 

if it's lognormal. If it was normal, of course
 

that would just be the regular standard
 

deviation.
 

So we do this for these — you know, in this
 

case, 1951 through '58 — from both an internal
 

and an external perspective, and identifying
 

whether it's an acute or a chronic exposure. We
 

just had that conversation that we are going to
 

default, unless known otherwise, an external
 

exposure will be classified as an acute exposure,
 

because we cannot tell from badge monitoring data
 

what the exposure scenario was unless there was
 

something in the person's file that was involved
 

in an incident, a criticality or something like
 

that. For neutrons, however, we're in the
 

position to be claimant-friendly of calling
 

neutron exposures chronic exposures, and all
 

alpha exposures from internal are going to be
 

chronic. So we defined those parameters.
 

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One thing that's not shown on here, though,
 

is the IREP allows for 11 different types of
 

radiation exposures. There are five neutron
 

energy intervals. There are three gamma energy
 

intervals, and then also there's electron
 

exposure, beta exposure, as well as a tritium
 

exposure — it has a slightly different radiation
 

weighting factor — as well as the alpha factor.
 

So we can select — I'm not suggesting that we're
 

going to know every claimant's exposure scenario
 

down to that level of detail, but it is there if
 

it's known.
 

Okay. How long are we going to expect these
 

dose reconstructions to take? It’s going to vary
 

all over the board. My guess — and I said
 

complex — you know, it may vary depending on
 

level of complexity. I said days to months.
 

I've seen, in looking through some of these
 

cases, that there's some that can probably be
 

done in a day or so, depending on — some of these
 

low dose ones where a person after interview
 

realizes that's their entire history, where it's
 

a fairly low potential external exposure
 

environment and the missed dose is fairly low.
 

The internal exposures, if we do our
 

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bracketing worst-case assumption and then go to
 

our conservative assumption and they still come
 

out kind of on the bubble, that's where we're
 

going to have to take and do a whole full-blown
 

dose reconstruction and account for every data
 

point and model the exposure, and that could take
 

months, particularly if we really don't know the
 

exposure very well, the exposure conditions of
 

the claimant.
 

I also say cases with extensive internal
 

exposure I expect to be the most complex. I
 

guess I just talked about that.
 

And additional time required for previously
 

unexamined locations and processes, we have these
 

atomic weapons employers. There's almost 300 of
 

them out there where we have almost no monitoring
 

data, and we know very little about the process.
 

That's going to take some time. I mean, it's not
 

intuitive, we're going to go in there and be done
 

in a day or two. That's going to take some
 

research and investigation to accomplish those
 

cases.
 

Okay. Where are we so far? I think it was
 

mentioned there's about 13- or 15,000 claims
 

hanging out in the system somewhere. We have in-


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house within NIOSH — I think last guess was about
 

1,500, is that close? — so we have about 1,500
 

claims in-house. So we're frantically working to
 

try to get this process in place.
 

It was never envisioned, though, that the
 

NIOSH staff itself would actually do all the dose
 

reconstructions. We have fairly limited
 

resources. We, in addition to myself, we have a
 

staff of three health physicists who are right
 

now working on getting the program in place.
 

We've — just a week or so ago the first draft of
 

the implementation guides themselves for external
 

dosimetry and internal dosimetry were completed,
 

and that's moving along.
 

We're working toward a Memorandum of
 

Understanding with the Department of Energy in
 

sharing their information. That right now is
 

undergoing internal review. The DOE is expecting
 

us to provide them a straw man version of that
 

Memorandum of Understanding, and hopefully that
 

will be issued sooner than later.
 

We are going through the process right now
 

of requesting DOE personnel monitoring
 

information. We're not right now going after any
 

of the work place information. We feel it's most
 

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appropriate right now to go for the personnel
 

monitoring information, to look at it, to
 

evaluate it to see how it can be used, and that's
 

going to be our starting point. In cases where
 

there is no monitoring information — for
 

instance, many construction workers were never
 

monitored — we need to then go out and start
 

looking at the on-site work place monitoring
 

data.
 

I think we've issued somewhere around 700
 

DOE requests for information so far, so we're
 

working to close that gap. Hopefully shortly
 

there'll be sort of a one-to-one correspondence
 

when the claimant's notified, that then we
 

receive their claim, that the DOE request for
 

information goes out.
 

We are looking at the records availability
 

at certain facilities. We have a pilot study —
 

two pilot studies that we've started, Oak Ridge
 

and Hanford. Those are moving slower than we'd
 

like. The Memorandum of Understanding will go a
 

long way towards, I think, helping define the
 

roles and responsibilities of the players
 

involved in doing these records searches.
 

We are developing a computer database. It's
 

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been talked about earlier that the Health-Related
 

Energy Research Branch within NIOSH has been
 

doing DOE workers studies for nine or ten years
 

now. They've developed a considerable database
 

of occupational monitoring records, mostly
 

oriented towards doing epidemiologic studies. We
 

are working in cooperation with HERB to collect
 

that information and assemble it in a form and
 

format that's useful for doing dose
 

reconstructions. And we hope to grow that
 

database and go and get more DOE information,
 

essentially have a very large internal database
 

that will allow us, as time goes by, to be less
 

and less dependent upon Department of Energy as a
 

resource for much information.
 

And most importantly to me at this point, we
 

have a request for contracts for dose
 

reconstruction assistance. It was in
 

procurement, but as of last week it is available.
 

We're expecting proposals due from the
 

contractor, I believe, February 19th, fairly
 

short turnaround time. We are working as fast as
 

we can to get a contractor on board who will do
 

the bulk of the dose reconstruction effort under
 

our guidance and quality control and oversight.
 

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Okay. I've come to the end of my formal
 

comments, be happy to answer any questions if
 

anyone has any.
 

DR. ZIEMER: Thank you, Jim.
 

Who has a question? Maybe I'll start it
 

out.
 

It seems to me there's a possibility that,
 

as you use newer models and do depth-dose
 

calculations for external, that your numbers
 

could come out quite different from what some
 

would call the dose of record in the agency.
 

That would seem to cause some problems with
 

potential claimants who would look at that and
 

say, well, there's my dose record. They tell me
 

that's my dose, and you guys are saying it's much
 

less than that.
 

DR. NETON: That issue —
 

DR. ZIEMER: I'm not asking you to answer
 

that, but it seems to me that's a problem that
 

the agency's going to have to deal with in terms
 

of talking to claimants. I'm pretty sure some of
 

the new ICRP 60 will give lower internal doses on
 

some of those organ doses than the older models
 

do.
 

DR. NETON: Not across the board.
 

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DR. ZIEMER: No, not across the board, so it
 

depends on what it is.
 

DR. NETON: Right.
 

DR. ZIEMER: I'm just saying it seems to me
 

there is that possibility.
 

DR. NETON: I agree, I think there's a —
 

DR. ZIEMER: The film badge dose, which is —
 

you know, the depth dose is one centimeter and
 

you're going deep, it's going to be a different
 

number.
 

DR. NETON: It's going to be — have to be a
 

very intensive communication campaign to educate
 

the claimants as to what we've really done. We
 

intend to do our best to get that out there in a
 

fairly comprehendible or comprehensible fashion
 

to the claimant.
 

I think in many cases this difference will
 

not be obvious, because most DOE programs don't
 

calculate a dose over the time period we're
 

looking at. I mean, we're going to look at the
 

time of first employment to date of diagnosis on
 

an annual basis, so internal exposures won't —
 

there will be no one-to-one correspondence with
 

those. External exposures, yeah, I think so.
 

But I think those are going to be closer. We're
 

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not doing anything fancy there, other than
 

accounting for some of the obvious geometrical
 

differences, which I think can be explained.
 

Another factor is that when you run IREP, if
 

you notice, what happens is we use the ICRP 60
 

weighting factors, radiation weighting factors,
 

to come out with an equivalent dose so that we
 

can report to the claimant something that makes
 

sense to them based on their past experience. I
 

mean, they're used to seeing like an equivalent
 

dose type number. But when IREP is run, it uses
 

the distribution for that radiation weighting
 

factor and applies it, so in a sense it's going
 

to be inflated — not inflated; it will be sampled
 

over its total distribution, so there is no point
 

estimate for the radiation weighting factor.
 

So there's a lot of these things that are
 

different that need to be explained to workers as
 

to why they are different, and why we did what we
 

did.
 

DR. ZIEMER: Other questions?
 

[No responses]
 

DR. ZIEMER: Okay, thank you very much.
 

We now come to the part of our agenda which
 

is the public comment period. We have requests
 

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from three individuals to speak.
 

Richard Miller requests to speak at 4:00.
 

Does that mean Rich is not here right now? You
 

are here, okay.
 

And David Richardson — David, how much time
 

do you anticipate you would need?
 

MR. RICHARDSON: Five minutes, maybe.
 

DR. ZIEMER: Oh, okay. I was just trying to
 

get a feel for this.
 

And Richard, about how much time do you
 

need? How much time do you need?
 

MR. MILLER: Five minutes.
 

DR. ZIEMER: Five minutes, okay. Then none
 

of these are extensive. I wasn't trying to force
 

anybody to use up the hour. So Richard, if you
 

would approach the mike, and you can use either
 

the mike here or maybe preferably go to the very
 

front so we can see you easily.
 

Richard is with the Government
 

Accountability Project. Richard Miller.
 

MR. MILLER: Greetings. I — the Government
 

Accountability Project, just to explain what it
 

is and why I'm here today, has been tracking the
 

implementation of this legislation, I guess
 

largely because I moved over there. I had
 

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previously worked for the Oil, Chemical and
 

Atomic Workers Union and then PACE, which had
 

spent a significant amount of effort trying to
 

pass this legislation. So it's quite interesting
 

for some of us who were involved in the
 

negotiations over the bill and the drafting of
 

the language and the lobbying that followed it to
 

now watch it play out before your eyes.
 

Needless to say, the law of unintended
 

consequences prevails, despite what we thought
 

were our best insights and what was politically
 

achievable. And I want to just focus on two
 

areas today.
 

The first is the composition of the Board,
 

over which you really have no control. But I —
 

just for what it's worth, and it is frankly
 

beyond the control of NIOSH or CDC by statute, as
 

the President, of course, appoints you all to
 

this Advisory Board, and the statute's very clear
 

on what the appointment process is supposed to
 

consist of. And I'm just going to read from the
 

statute one paragraph, if you can indulge me,
 

which is Section 3624 on the Advisory Board.
 

It says, (Reading): The President shall
 

make appointments to the Board in consultation
 

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with organizations with expertise on worker
 

health issues in order to assure that the
 

membership of the Board reflects a balance — key
 

word — of scientific, medical and worker
 

perspectives, and the President shall designate a
 

Chair, which he has done.
 

The question is whether the Board in fact is
 

constructed with a balance, as was intended by
 

Congress. Now balance can mean a number of
 

different things to different people. But if I
 

see three criteria and there's roughly ten people
 

on the Board so far, a third should fall into
 

each of those categories, give or take. You've
 

got a little bit of wiggle room there; you can
 

have four in one category and three in others.
 

And likewise, if the Board were increased in
 

size, you would still expect some kind of
 

proportional allocation.
 

Now it doesn't specifically say what the
 

areas of science are or are not, but from the
 

outside at least — and again, it is not a
 

criticism of any individual here on the Board or
 

whether they should or should not have been
 

appointed — but it is an observation for those of
 

us who are watching you deliberate on providing
 

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advice that the constitution of this Board
 

woefully underweights worker representation. And
 

it is indisputable, at least from my perspective,
 

that the only worker here is Richard Espinosa on
 

the committee, as I think Congress had intended,
 

what they meant by worker perspectives. And —
 

well, each person's entitled to their views, and
 

I will offer mine.
 

If — with that in mind, the question becomes
 

— everybody, by the way, is a worker, because if
 

everybody's collecting a paycheck you're
 

effectively a worker. The question is whether
 

you are or were in a position to be in management
 

control or not. And this was a law which was
 

intended to benefit, in effect, those who had the
 

least power in a process that was largely
 

conducted in a self-regulated and generally under
 

significant secrecy.
 

So today, when you look at this body
 

deliberating within this framework on this
 

matter, from those of us from the outside at
 

least, some of us believe that the Board is not
 

adequately constituted. Will this affect the
 

outcome of the deliberations? You know, it's a
 

social science experiment.
 

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Nevertheless, I just thought I would put
 

that on the table because it is something that we
 

very much would like to see done, and I want it
 

on the record that this body, at least as
 

constituted from our perception, does not meet
 

those criteria. And we've communicated those
 

views to the President.
 

The second issue which I wanted to address
 

has to do with the — what Jim Neton was talking
 

about, which was the forthcoming contract. And
 

I've brought a letter which I sent to NIOSH — and
 

I apologize, I only brought nine copies, so we'll
 

have to get an extra one — but I brought some
 

along, and I apologize for being one short. I
 

think somebody borrowed one of my ten copies.
 

And what this gets to is the fact that as
 

NIOSH moves forward with its dose reconstruction
 

contracting process and the RFP's on the street,
 

NIOSH has been, I think, sensitive to, at a staff
 

level, concerns about conflict of interest. And
 

the concerns around conflict of interest largely
 

rest, at least from my perception, that there are
 

likely to be perhaps only two bidders for this
 

dose reconstruction contract.
 

I don't know that there will only be two,
 

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but I have every reason to believe there will
 

only be two based on conversations with the —
 

sort of the contractors who showed up at the
 

bidder's conference that was held in Cincinnati.
 

And those two contractors, so that there's no
 

mistake and no secrets about it, are going to be
 

one team headed by SAIC and likely include
 

Battelle, and a second one which is going to be
 

headed up by Oak Ridge Associated Universities
 

and may include MJW or someone else. But they're
 

going to be the — those are going to be the two
 

folks.
 

Now the statute, specifically the energy
 

employees statute, when it spoke to the question
 

of performing dose reconstruction work, was very
 

specific in precluding either the Secretary of
 

Energy or his or her designees or subordinate
 

officers from performing the dose reconstruction
 

work. It didn't say DOE contractors couldn't
 

perform it, but it sought by assigning out this
 

work for dose reconstruction away from what's
 

perceived to be the agency, which could in some
 

respects be considered culpable if there's harm
 

involved.
 

And so what do we do? What do you do if the
 

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folks who were involved in doing the work are
 

involved in doing the dose — who are doing the
 

dose reconstruction contract have relationships
 

within the Energy Department?
 

Now NIOSH has done an excellent job of
 

putting a crisp paragraph in its contract RFP
 

that is on the web now which says, you know, if
 

you're performing work at a given site you can't
 

be involved in doing the dose reconstruction work
 

at that site. Does that go far enough? I think
 

it's an important first step.
 

Our concern and perception, as our letter
 

lays out, is that there needs to be transparency,
 

that the individuals that are hired by the teams
 

need to be disclosed. What is their work
 

history? Where did you work, who did you work
 

for, both at an organizational as well as an
 

individual level? And it needs to be transparent
 

to the claimant. It probably needs to be
 

transparent to you, as you provide quality
 

assurance over this process as well.
 

We don't know if there's a way out of this
 

conflict of interest problem because it's a small
 

pool of highly-qualified individuals with a great
 

deal of expertise. And in fact, in some
 

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respects, the RFP almost constrains you to using
 

DOE contractors for the very work. You have this
 

— it's the classic conundrum, right? How do you
 

get independence at the same time you have
 

concentrated expertise?
 

Well, our sense is that there needs to be a
 

high degree of transparency, a clear-cut list of
 

do-nots, which include such things as acting as
 

an expert witness or supporting litigation in
 

defense of claims involved in — where there's an
 

allegation of radiation causing occupational
 

illness at a particular site. We've got to have
 

a clear-cut set of do-nots and a clear set of
 

transparencies that go back and forth between the
 

claimant and NIOSH, so that you don't get down
 

the road into the dose reconstruction and people
 

stick up their hand when the case becomes
 

appealed and say conflict.
 

So we would just like to suggest — although
 

it's not on your agenda for today, it did get
 

raised by Mr. Neton — and I just thought I'd
 

segue off your presentation and encourage you to
 

think about what can be done to raise the level
 

of confidence that the claimants will have in a
 

system where, as the Congressional record and the
 

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hearing record — I happened to testify in this
 

legislation several times and worked with many
 

workers who did testify, and went to many of the
 

field hearings that Dr. Michaels, who I guess is
 

here in the back of the room, held when he was
 

the Assistant Secretary at the Energy Department,
 

and those hearings revealed a high degree of
 

irregularity in the dose estimation and dose
 

collection processes.
 

And if there's a concern about a high degree
 

of irregularity, coverup — we had documents where
 

major DOE contractors like Lockheed-Martin were
 

actually doctoring the data in order to avoid
 

culpability in worker compensation claims, and
 

these documents are out there in the public
 

record. You know, the names may be redacted, but
 

the facts are all there.
 

And so I think it's important for you all to
 

think about how to build credibility into the
 

contracting process, because the best procedures
 

in the world won't overcome that skepticism. So
 

that's all I had to add.
 

Thank you.
 

DR. ZIEMER: Thank you, Richard, and your
 

comments will indeed be in the public record.
 

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I might ask if any of the committee members
 

have questions of Richard that you'd like any
 

points clarified?
 

[No responses]
 

DR. ZIEMER: Thank you.
 

Next, David Richardson from Department of
 

Epidemiology, University of North Carolina at
 

Chapel Hill.
 

MR. RICHARDSON: Hi.
 

I want to, I guess, talk to you a little bit
 

first about my background. I've worked in
 

epidemiology on studies of U.S. DOE workers at
 

Oak Ridge and Hanford, and participated in the
 

case-control study that took place at multiple
 

DOE facilities.
 

And so I want to make a couple of points
 

just in response to the discussion that I heard
 

today from the perspective of an epidemiologist,
 

and maybe also just to start out by saying I
 

think NIOSH has done an impressive job so far.
 

mean, I think the approach that you're using is
 

certainly cutting edge, and you've done a lot of
 

hard work in trying to think about both issues of
 

bias and uncertainty.
 

And those are certainly two key points, and
 

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I — so as my first point as — raising is to move
 

beyond talking about bias and uncertainty to
 

talking about effect modification. And it's
 

something that a few people have raised already
 

on the edges, so it's something to think about.
 

From studies of U.S. DOE workers that I've
 

been involved with and that other people before
 

me have been involved with, and after the work
 

that I've done I’ve been involved with, I think
 

one interesting example of effect modification
 

comes with the issue of age at exposure. So
 

under the current probability of causation tables
 

for a given dose history, for a worker's dose
 

history, the excess relative risk or the — and
 

therefore the probability of causation for that
 

worker tends to decline with older ages at
 

exposure. That is — I'll maybe modify that and
 

say it's either constant or it's declining, and
 

there's a tendency for the solid cancers for it
 

to decline.
 

In contrast, in a number of studies of U.S.
 

nuclear workers you see the opposite pattern.
 

And that's to say people who accrue radiation
 

exposures at older ages appear to have larger
 

excess relative risks. There's a larger increase
 

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in cancer.
 

Now I'll stress here that this is not — I'm
 

not talking about the difference between infants
 

or children and adults. I think that's — I think
 

it's clearly established in the literature that
 

the developing fetus, the growing child is
 

extremely sensitive to the effects of radiation.
 

I'm talking here about a range of age that's
 

going to be something like 18 to 20 years when
 

you start work, to 65 or 70 years of age when you
 

stop work.
 

And the evidence from a series of U.S. DOE
 

nuclear worker studies is that — kind of similar
 

to what you see for lots of other occupational
 

hazards. As people get older they become
 

increasingly vulnerable to injury on the job —
 

here, radiation-induced injury — and the
 

biological plausibility would be related to
 

either declining ability of the body to
 

accurately repair damage to genes and/or
 

declining ability of the immune system to
 

scavenge up damaged cells.
 

So to take some examples, the early — I
 

think the early evidence of this came in early
 

reports of the Hanford cohort, which was one of
 

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the first studies. That was when you began
 

compiling nuclear worker records in the atomic
 

weapons complex. Subsequent to that there was
 

the evidence of increased radiation effects at
 

older ages of exposure in the Oak Ridge workers
 

cohort, then in a multi-facility study across the
 

DOE complex of multiple myeloma where older ages
 

at exposure were associated with larger increases
 

in cancer risk, and then in the Rocketdyne study
 

that was done out by the University of California
 

group.
 

So there's different ways of thinking about
 

this. One is that there's a conflict of evidence
 

between the life span study of atomic bomb
 

survivors, which I think it's important to stress
 

is really the numerical quantitative foundation
 

of the tabulations that you're seeing that are
 

spinning out of almost a black box computer; that
 

there's a study there of people who were wartime
 

survivors of an atomic attack, and the exposure
 

conditions are different than the DOE workers.
 

Another at least issue to raise with that
 

would be effect modification coming from — I
 

think an interesting point that a lot of people
 

have already raised, yes, you've looked at
 

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smoking as an effect modifier, but workers are
 

getting exposed to chemicals, and they're
 

accruing other exposures on the job. There's a
 

possibility that it's not a simple either
 

additive or multiplicative translation of the
 

life span study to the DOE complex; that workers
 

have a different set of initiating and promoting
 

carcinogenic exposures on the job, and that the
 

age at exposure pattern is different.
 

And what I would propose is that at minimum
 

that inconsistency in the literature is
 

recognized and in some way accounted for. And
 

one way that I would propose that is there is a
 

series of factors now going on that reflect
 

uncertainties. There's uncertainties in
 

translation of additive or multiplicative
 

effects. There's uncertainties in dose
 

measurements, both in the DOE complex and dose
 

measurement in the A-bomb studies, that you begin
 

to have also reflecting an uncertainty in the
 

effect of radiation at older ages of exposure.
 

You don't have to incorporate any bias or
 

anything, but you say there's — the literature is
 

not consistent in the range of exposures. So
 

when you begin to look at effects of exposures
 

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that are received at the older span of a worker's
 

life, you say the effect is more uncertain than
 

the simple point estimate coming from the life
 

span study.
 

So that would be my — that would be the
 

first point that I'd like to raise.
 

Kind of following from that, I'd like to
 

also just briefly talk about an issue that maybe
 

at minimum needs a point of clarification and
 

maybe some more exploration, which relates to the
 

discussion that by default external radiation
 

exposures are treated as acute. And the
 

implication here is that the DDREF, the dose and
 

dose-rate effectiveness factor, therefore
 

undergoes a shift.
 

It goes from treating it as an exposure that
 

was accrued slowly over time to one that's
 

accrued in a point blast, and therefore that the
 

DDREF is one, or that there's — let me take a
 

step back and say that external doses are going
 

to be treated as acute, and therefore this issue
 

of is the effect attenuated because it was a
 

chronic exposure, is that set aside.
 

And in fact, as I understand the current way
 

the program is running, it's proposed that any
 

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external dose that's less than 20 or 30 rem,
 

which from my familiarity with the Hanford/Oak
 

Ridge/Los Alamos data this is going to
 

incorporate 99.9 percent — I'm making up a
 

percentage — but it's going to be the vast, vast
 

majority of the dose is substantially — any
 

annual dose record is substantially below 20 or
 

30 rem for a worker. I mean, workers did accrue
 

doses in the DOE complex, but it was over decades
 

of employment.
 

So here the DDREF factor, you begin to say
 

the effect of a worker's dose is going to be
 

divided by a factor of two, three, four or five —
 

the effectiveness of that dose — because it was a
 

low dose. That is not — it's not because it was
 

a chronic versus acute, it's because it's in the
 

low — the spectrum of the lower end of the dose
 

distribution.
 

And as Mary Schubauer-Berigan brought up, in
 

fact, the evidence now, if you're going to take
 

the recent RERF reports from the life span study,
 

they're not supporting a departure from
 

linearity. I would argue that, from the
 

perspective of an epidemiologist, a DDREF factor
 

of multiples of two, three, four or five for
 

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these low — these doses, which is almost all the
 

doses that you're talking about in this program,
 

is — I'm not sure it's supported by the
 

epidemiologic evidence.
 

And so you have to then turn to evidence
 

that's accrued from studies of animals’ exposures
 

or cellular responses. I think the literature —
 

studies of the effects of low-level exposures to
 

animals, it does get iffy. Most of the
 

literature is higher dose exposures to animals.
 

When you're looking at low-level exposures, the
 

end point is not going to be cancer incidents, or
 

very rarely.
 

Anyway, so I think that's another issue that
 

I would open, and I think particularly if you're
 

talking about issues of benefit to the doubt for
 

the worker from the perspective of epidemiology,
 

I think that's a really important point to
 

consider and debate further.
 

DR. ZIEMER: Thank you. David, I'd like to
 

ask you to clarify one thing. Are you arguing
 

that the dose-rate effectiveness factor should be
 

one, and not two or three or some other value?
 

MR. RICHARDSON: I would argue —
 

DR. ZIEMER: Because I'm understanding this
 

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in almost the opposite way. I think lowering it
 

lowers the effective dose. Is that — are you
 

arguing that we're over-estimating doses at —
 

MR. RICHARDSON: The effects of a dose, a
 

lower dose, is going to be divided. The way that
 

this factor is applied for low-LET radiation —
 

DR. ZIEMER: I guess I may have
 

misinterpreted how they're using it, then.
 

MR. RICHARDSON: I don't know. Mary, could
 

—
 

DR. ZIEMER: I thought we were multiplying,
 

but I would ask that we get that clarified.
 

MR. RICHARDSON: I think Mary could answer
 

that.
 

DR. ZIEMER: Typically a dose-rate
 

effectiveness factor operates like a quality
 

factor. It increases —
 

DR. SCHUBAUER-BERIGAN: Actually, it —
 

DR. ZIEMER: It would increase the
 

probability of causation rather than decrease it.
 

I believe that is the case.
 

DR. SCHUBAUER-BERIGAN: Well, what acts like
 

a quality factor actually is the RBE. Those two
 

are sometimes used interchangeably. But David is
 

correct, that when the DDREF factor is applied, a
 

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factor of greater than one implies that the risk
 

per unit exposure at a very — at a low dose or in
 

a chronic dose is divided by that value.
 

MR. RICHARDSON: Right.
 

DR. SCHUBAUER-BERIGAN: So if it's two, the
 

effect of that dose is divided by two.
 

DR. ZIEMER: Thank you.
 

MR. RICHARDSON: Right. And so the question
 

is, is there — here, I think, everything is being
 

essentially treated as an acute dose for the
 

external here, talking again about the low-LET
 

doses. So it's not — the issue of dose-rate is
 

not really so much a consideration. It's is the
 

dose-response association linear in the low dose
 

range? And, I mean, that is something that
 

people talk about.
 

DR. ZIEMER: I understand what you're
 

saying.
 

MR. RICHARDSON: But the current — I’d say a
 

lot of committees are taking now, and a lot of
 

the literature, is supporting the opinion that a
 

linear dose response is a reasonable association.
 

And I — you know, I would argue maybe yes, that
 

you would have a factor centered around one, and
 

then you allow uncertainty in that.
 

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DR. ZIEMER: Are the studies that you cited
 

in your written comments that were submitted to
 

the agency earlier?
 

MR. RICHARDSON: Yes.
 

MR. ELLIOTT: Yes, they're referenced and we
 

have copies of those.
 

DR. ZIEMER: Thank you.
 

Next we have — I think it's Roger. Is it
 

Roger?
 

MR. SHAW: Yes.
 

DR. ZIEMER: I couldn't read your writing
 

here — Roger Shaw from McCarter & English, Ltd.
 

MR. SHAW: Yes, this will be less than five
 

minutes.
 

Let's go right to DREF. I just want to
 

mention DREF. I know that the Board will look at
 

it. It's an important item. For low-LET,
 

UNSCEAR, ICRP, NCRP and BEIR V support a DREF for
 

low-LET of anywhere from two to five. I think I
 

heard Mary earlier — I asked her specifically on
 

a break if there'd be a range of maybe between
 

less than one to five, and that's something that
 

is a little different than maybe what the RERF
 

may be saying in one of their recent studies.
 

But I think it really deserves a lot of
 

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caution and is something that should be looked
 

at. A lot of important national, international
 

bodies support that you use a DREF. And for
 

example, if it was two, that would mean that the
 

risk would be less by a factor of two. So that
 

is something I just — I know you'll look at. I
 

just want to mention that.
 

And if we do start to define acute versus
 

chronic in a different way, if we start to say
 

that an acute dose is something received over a
 

month or two months or a quarter, over a
 

quarterly badge reading period for TLD or film,
 

then we're going to have to start rewriting
 

textbooks and doing that fairly quickly, because
 

that is not historically how acute dose has been
 

defined.
 

The second item is with the dose uncertainty
 

and how critical that is. Dr. Ziemer pointed
 

out, as we went through NIOSH-IREP, or Russell
 

did, Mr. Henshaw — and showed exactly what
 

happens when you change the uncertainty
 

associated with those doses. And it can make
 

huge differences. As I'm sure you get home and
 

you work tonight, and you start to go through and
 

do your own iterations with NIOSH-IREP, you will
 

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start to see these differences.
 

And if you simply change and go and look —
 

and they're different for different cancers — but
 

if you look at one leukemia, you look at CML, and
 

you take and change that, you just leave all the
 

parameters the same for a certain dose. If you
 

took 25 rem, five rem for five years, and put in
 

the information you want to put in, just change
 

constant, which means no uncertainty — not really
 

realistic — and change that to normal geometric
 

standard deviation, gSD. Well, for gSD that's 40
 

percent PC. And if you just change that to
 

constant alone, it goes to 93 percent probability
 

of causation.
 

So as Congress has said, let's err on the
 

side of the claimant. We should. It sounds
 

fair. It is fair. It doesn't mean that we need
 

to add undue uncertainty on top of an already
 

large amount of uncertainty that we're going to
 

be stuck with and also have to deal with in a
 

reasonable fashion.
 

Those are the two points.
 

DR. ZIEMER: Thank you, Roger.
 

And again, are there any questions or issues
 

to be clarified?
 

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[No responses]
 

DR. ZIEMER: All right. Thank you.
 

This completes today's agenda. I would ask
 

that the four other members of the subcommittee
 

stop by here for a moment before we adjourn — or
 

right after we adjourn, and we'll talk about the
 

assignment for this evening.
 

We thank all of our guests who were here
 

today. We will reconvene tomorrow at 8:00
 

o'clock; 8:00 o'clock, not 8:30, okay? So we'll
 

see you all in the morning at 8:00 a.m.
 

Thank you very much.
 

[Whereupon, the meeting was
 

adjourned at approximately
 

5:05 p.m.]
 

NANCY LEE & ASSOCIATES
 
 

 

__________________________ 

249 

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]