January 22, 2002 - Continued
3:45 - 4:30 Dose Reconstruction Rule 42 CFR Mr. Ted Katz

Part 82 General Background Dr. James Neton
Technical Approach - Overview

4:30 - 5:30 Public Comment Period

January 23, 2002

8:00 - 8:30 Administrative Orientation Ms. Corrine Homer

8:30 - 8:45 Board Work Schedule Mr. Larry Elliott
Ms. Corrine Homer

8:45 - 12:15 Working Session on Probability of Causation Comments

12:15 - 1:00 Lunch

1:00 - 2:00 Public Comment Period

2:00 - 3:00 Dose Reconstruction Rule 42 CFR Dr. Jim Neton

Part 82 Technical Guidelines for
External Dose Reconstruction and
Internal Dose Reconstruction
3:00 - 3:15 Break

3:15 - 4:15 Working Session on Probability of Causation
and/or Dose Reconstruction Comments

4:15 - 4:30 Closing Comments/Adjourn Dr. Paul Ziemer - Chair

**** Agenda items are subject to change as priorities dictate. ****



January 22, 2002

8:30 - 9:00

9:00 - 9:30

9:30 - 10:00

10:00 - 10:15

10:15 - 10:45

10:45 - 12:00

12:00 - 1:00

1:00 - 1:45

1:45 - 2:30

2:30 - 2:45

2:45 - 3:45

Enclosure 2

Meeting Agenda

Advisory Board on Radiation and Worker Health
Holiday Inn on the Hill,,Washington, D.C.

415 New Jersey Avenue, N.W.
Washington, D.C. 20001

(202) 638-1616

January 22-23, 2002

Welcome and Introductions

FACA Orientation

Film on Committee Membership
Break

Office of General Counsel
Briefing

Review of EEOICPA,
Executive Order and Charter

Lunch

Board Responsibilities/
Operating Procedures

Probability of Causation Rule 42 CFR

Part 81 General Background
Scientific and Technical Basis

Break

Interactive Radioepidemiologic
Program (IREP)

Dr. Ziemer, Mr. Elliott and
Board Members

Ms. Helen Kuykendall
CDC Committee Management
Office

Ms. Mary Armstrong
Office of General Counsel

Mr. Larry Elliott
Executive Secretary

Dr. Paul Ziemer - Chair
Mr. Larry Elliott
Executive Secretary

Mr. Ted Katz
Dr. Mary Schubauer-Berigan

Mr. Russ Henshaw and
Dr. Mary Shubauer-Berigan



gre mC,

-
<<

CHAIRMAN:
Paul L. Zsemer, Ph.D.
Lafayette, Indiana

MEMBERS:

Henry A Anderson, M.D.
Madison, Wisconsin

Antonio Andrade, PhD.
Les Alamos, New Mexico

Roy L. DeHart, M.D., M.P.H.
Nashville, Tennessee

Richard L. Espinosa
Espanola, New Mexico

‘Safly L. Gadola, M.S., R.N., COHN-S
Oak Ricige, Tennessee

James M. Melius, M.D., Ph.D.
Albany, New York

Wanda |. Munn
Richiand, Washington

Robert W. Presley
Clinton, Tennessee

Genevieve S. Roessler, Ph.D.
Elysian, Minnesota

STAFF:
EXECUTIVE SECRETARY:
Larry J. Eliott

on nnat Ohi
COMMITTEE MANAGEMENT :

Cori B. Homer
Atlanta, Georgia

ADVISORY BOARD ON RADIATION AND WORKER HEALTH

4676 Columbia Parkway, MS: R-45
Cincinnati, Ohio 45226
(513)841-4498

February 6, 2002

The Honorable Tommy G. Thompson

Secretary, Department of Health and Human Services
200 Independence Avenue

HHH Building, Room 603G

Washington, D.C. 20201

Dear Secretary Thompson:

The Advisory Board on Radiation and Worker Health held its first
meeting on January 22 and 23, 2002, in Washington, D.C. All of
the currently appointed members were present as well as the
designated Federal Official who serves as Executive Secretary.
The sessions were open to the public in accordance with Federal
Advisory Committee Act requirements and were attended by a
variety of individuals representing themselves or interest groups.
A copy of the meeting Agenda is enclosed for your information.

In preparation for the meeting, the Board members individually
reviewed proposed National Institute for Occupational Safety and
Health (NIOSH) rulemaking for 42 CFR 81 (Guidelines for
Determining the Probability of Causation Under the Energy
Employees Occupational Illness Compensation Program Act of
2000) and 42 CFR 82 (Methods for Radiation Dose
Reconstruction Under the Energy Employees Occupational Illness
Compensation Program Act of 2000). The members also
reviewed written comments by subject matter experts and by
members of the public for these two rules. At the Board sessions,
formal presentations were provided by NIOSH staff members on
these and related issues, Also, comments were provided by some
of the members of the public who were in attendance.

Under the provisions of the President’s Executive Order of
December 7, 2000, the Advisory Board has very specific
responsibilities on advising the Secretary of Health and Human
Services. In accordance with those responsibilities, I am pleased
to provide the Advisory Board’s recommendations concerning the
proposed Guidelines for Determining Probability of Causation as
set forth in 42 CFR Part 81. These recommendations are
summarized in Enclosure 1.



Page 2 - The Honorable Tommy G. Thompson

In addition to dealing with the specific items mandated by the Executive Order,
The Advisory Board wishes to comment on its current composition and make-up.
We note that since the Public Law under which the Advisory Board was
established provides for up to 20 members, and since the current number of
members appointed is 10, there may be additional future appointments made to the
Board. As a means of diminishing any perceived or real imbalance amongst the
various sectors represented by the Board membership, the Board suggests that
additional representation from the nuclear production workers sector would be a
clear advantage and benefit to the Board in carrying out its mandate.

Please let me know if additional information or clarification is needed concerning
the recommendations contained herein.

Sincerely, -
xa 7

Paul L. Ziemer, Ph.D., CHP
Chairman

Enclosures (2)
ce:
Members, Advisory Board on Radiation and Worker Health



Enclosure 1

Recommendations and Comments from the Advisory Board on Radiation and

Worker Health

The following comprise recommendations and comments from the Board in the context of

responses to the three major questions found in Section I of the Preamble to the proposed rule,

42 CFR Part 81

1. The Board agrees that the NIOSH guidelines and procedures for probability of
causation determinations have been developed using the best and most current
scientific information relating radiation exposures to cancer risks. The use of
current recommendations from independent expert bodies lends strength to the
approach proposed by NIOSH. The NIOSH approach also implements the spirit of
concem for nuclear workers that was inherent in the legislation underlying this
compensation program. In this context, the NIOSH guidelines and procedures
provide an appropriate application of existing science to the compensation process.

2. The Board has also noted the differences between the approach being used in
this compensation program and that of the Atomic Veterans Act. There are
significant differences in the categories of compensation covered by the two acts.
In some cases, the Atomic Veterans Act required primarily that the claimants were
present in a specific area, had one of the specified cancers, and were therefore
compensated. This proposed rule is an effort to address much more complicated
situations and to face the reality that simple exposure to radiation does not
automatically presume the development of disease. The Board recognizes the
excellent efforts of NIOSH staff and their subject matter experts in bringing the
best known current science to an appropriate method for translating experience
gained in the veterans exposure calculations to this civilian nuclear worker
proposal.

3. The Board also agrees that the proposed NIOSH procedures appropriately
allow for the incorporation of new scientific information into the compensation
procedures as this new information becomes available. However, given the limited
time that the Board has had to review the details of the probability of causation
procedures and the potential impact of changes in the NIOSH IREP on
compensation decisions, the Board recommends that the regulations be amended
to formalize the role of the Board in reviewing any substantial changes in

these procedures (i.e., the NIOSH IREP). This change should include publication
of the planned changes in the Federal Register, an appropriate opportunity for
public comment, and then review by this Board before finalization. Although these
actions are included in the Preamble "Background," (Section II, Subsection I,
Paragraph 3) of 42 CFR Part 81, making them part of the rule itself would
formalize the updating process, significantly strengthening assurance that review of
revisions by the Board will occur.