February 13. 2002
8:30 a.m. - 9:00 a.m

9:00 a.m. - 9:45 a.m.

9:45 a.m. - 10:00 a.m.

10:00 a.m. - 11:00 a.m.

11:00 a.m. - 12:00 p.m.

12:00 p.m. - 1:00 p.m.

1:00 p.m. - 2:30 P.M.

2:30 p.m. - 2:45 p.m.
2:45 p.m. ~ 3:45 p.m.
3:45 p.m. - 5:00 p.m.

5:00 p.m.

DRAFT AGENDA

Advisory Board on Radiation and Worker Health

Washington Court Hotel
525 New Jersey Avenue, N.W.
Washington, D.C. 20001
(202) 628-2100
February 13-14, 2002

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

Registration and Welcome

Program Report Mr. Larry Elliott, Executive Secretary

Break
Recap of Advisory Board

Comments on Probability
Of Causation Rule (42 CFR Part 81)

Mr. Larry Elliott, Executive Secretary

Status of Rule Promulgation Russ Henshaw, NIOSH

(42 CER Part 81)
Lunch

Status of Rule on Dose Jim Neton, NIOSH
Reconstruction (42 CFR Part 82)

Break
Board Discussion
Public Comment Period

Adjourn

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


2. The Advisory Board requests that the term “validated”, as used in Section 82.10 (j),
be either defined or clarified.

3. The Advisory Board recommends that NIOSH clarify 82.10 (m), (n), and (0) in
regards to the steps and timeline required for the claimants, or authorized representatives
of the claimants, to provide information to NIOSH and to sign or submit form ‘OCAS-1’.
NIOSH should ensure that the claimants, or authorized representatives of the claimants,
have adequate time to obtain and submit additional information to NIOSH.

4. The Advisory Board recommends that Section 82.18, concerning the use of
International Commission on Radiological Protection (ICRP) models, be clarified so as to
clearly indicate that NIOSH intends to use current ICRP models.

5. The Advisory Board recommends that the last sentence in Section 82.28 (b), be
clarified in regards to the coverage of the Privacy Act.


February 14, 2002
8:30 a.m. - 9:00 a.m.

9:00 a.m. - 9:15 a.m,

9:15 a.m. - 10:15 a.m.

10:15 a.m. - 10:30 a.m.

10:30 a.m. - 11:30 a.m.

11:30 a.m. - 11:45 a.m.

11:45 a.m. - 1:00 p.m.
1:00 p.m. - 2:00 p.m.
2:00 p.m. - 3:00 p.m.
3:00 p.m. -4:00 p.m.

4:00 p.m.

DRAFT AGENDA
Advisory Board on Radiation and Worker Health
Washington Court Hotel
525 New Jersey Avenue, N.W.
Washington, D.C. 20001
(202) 628-2100
February 13-14, 2002

Registration and Welcome Dr. Paul Ziemer, Chair
Mr. Larry Elliott, Executive Secretary

Administrative Housekeeping Ms. Cori Homer, NIOSH

Special Exposure Cohort Ted Katz, NIOSH
Petitioning Process
Break
Board Work Schedule Mr. Larry Elliott, Executive Secretary

Ms. Cori Homer, NIOSH
Public Comment Period
Lunch
Board Working Session
Board Discussion
Public Comment Period

Adjourn

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


a
,

CHAIRMAN:
Paut L. Ziemer, Ph.D.
Lafayette, Indiana

BEAL
ot ALT,

g

MEMBERS:

Henry A. Anderson, M.D.
Madison, Wisconsin

Antonio Andrade, PhD.
Los Alamos, New Mexico

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

ADVISORY BOARD ON RADIATION AND WORKER HEALTH
4676 Columbia Parkway, MS: R-45
Cincinnati, Ohio 45226
(613)841-4498

February 28, 2002

The Honorable Tommy G. Thompson
Secretary, Department of Health and Human Services

200 Independence Avenue
HHH Building, Room 603G
Washington, D.C. 20201

Richard L. Espinosa

E 1a, New Mexi
‘Spano! wo Dear Secretary Thompson:

Sally L. Gadola, M.S., R.N., COHN-S
Oak Ridge, Tennessee

The Advisory Board on Radiation and Worker Health held its second meeting
on February 13 and 14, 2002, in Washington, D.C. Nine of the ten 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.

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

Wanda |. Munn
Richland, Washington

Robert W. Presley
Clinton, Tennessee

Genevieve S. Roessler, Ph.D. . : we
Elysian, Minnesota The primary focus of the meeting was the proposed rule-making in

. 42 CFR, Part 82 (Methods for Radiation Dose Reconstruction Under the
Energy Employees Occupational Illness Compensation Program Act of 2000).

STAFF: In preparation for the meeting, the Board members individually reviewed the
EXECUTIVE SECRETARY: Draft Interim Rule as well as Draft Implementation Guidelines for Internal Dose
Larry J. Elliott Reconstruction and External Dose Reconstruction. At the Board sessions,

formal presentations were provided by National Institute for Occupational
Safety and Health staff members on these and related issues. In addition,
comments were provided by some of the members of the public who were in
attendance.

Cincinnati, Ohio

COMMITTEE MANAGEMENT :

Cori B. Homer
Atlanta, Gi ji a . :
antsy Georgia 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


Page 2 - The Honorable Tommy G. Thompson
pleased to provide the Advisory Board’s recommendations concerning the proposed Guidelines
for Determining Probability of Causation as set forth in 42 CFR, Part 82. These
recommendations are summarized in Enclosure 1.
Please let me know if additional information or clarification is needed.

Sincerely,

AER

Paul L. Ziemer, Ph.D., C.H.P.
Chairman

Enclosures (2)

ce:
Members of the Advisory Board on Radiation and Worker Health


Enclosure 1

Recommendations and Comments from the Advisory Board or Radiation and
Worker Health

The following comprise recommendations and comments from the Advisory Board in the
context of response to the three major questions found in Section I of the Preamble to the
proposed rule, 42 CFR, Part 82:

Interim proposed rule 42 CFR, Part 82, makes appropriate use of current science in
reconstruction of radiation dose scenarios to the extent practicable. The Board
recognizes that if the efficient and expeditious consideration of claims is to be made,
absolute precision is not possible. The methods proposed are intended to result in dose
estimates favorable to the claimants and are appropriate to the occupational illness
compensation program envisioned by the Energy Employees Occupational Iliness
Compensation Program Act (EEOICPA).

The process for involving the claimant is fair and provides multiple opportunities for
interaction with the involved agencies. Indeed, in cases where acceptably dependable
personal exposure data do not exist, the National Institute for Occupational Safety and
Health (NIOSH) will utilize other sources of information as the basis for dose
reconstruction. This approach unavoidably introduces additional uncertainty into the
calculation of dose. However, we view the proposed methods as being appropriate for
the available information. There will be circumstances where NIOSH will not be able to
estimate the dose with sufficient accuracy. Those circumstances need to be clarified in
the implementation of the regulation and in the Board’s review of NIOSH’s dose
reconstruction work. Groups whose exposure cannot be estimated with sufficient
accuracy may be candidates for the Special Exposure Cohort.

In addition to the recommendations relating to the questions set forth in Section I of the
Preamble, the Board has the following specific comments and recommendations:

1. The Advisory Board recommends that Section K of Part III, “background” concerning
changes to scientific elements underlying the dose reconstruction process be moved to the
main body of the Rule so as to formalize the updating process including the role of the
Advisory Board, The rule does an admirable job of providing an objective process for
conducting dose reconstruction. However, the assessment of the adequacy of the
exposure information will involve professional judgment, and thus, some subjectivity.
The Board plays an important role through its review of such decisions on dose
reconstructions, and that role needs to be included in the main body of the Rule.
Although this role is included in the Preamble “Background” (Section III, Subsection K)
of 42 CFR, Part 82, making it part of the rule itself would formalize the change process,
significantly strengthening assurance that review by the Advisory Board of proposed
changes will occur.