12.

in providing some level of equity between the definition of new SEC classes and
those already defined in the legislation. Accordingly, the Advisory Board
recommends that the Department of Health and Human Services remove the
provision to limit the cancers eligible for compensation for a particular class being
considered for special cohort status, and modify this paragraph accordingly.

Page 11309, Column 2, Section 83.13 (b)(2)(iii): The same issue concerning
tissue-specific sites, as outlined in item 11 above, arises in this paragraph. Hence,
the same comments by the Board apply here as well.

- Page 11309, Column 1, Section 83.13 (b)(1) (iv) and Section 83.13 (b) (3): Both

of these sections include the concept of “not feasible to estimate doses with
sufficient accuracy.” The idea of “sufficient accuracy” is not completely clear or
obvious. It would be helpful if NIOSH could provide additional clarification of
this concept. Therefore, the Advisory Board recommends that guidelines
addressing feasibility and sufficient accuracy be developed. These guidelines
should be developed by NIOSH within a reasonable time period after the
promulgation of the regulation and should be submitted to the Board for review.
Appropriate changes should be made in the regulation to indicate the planned
development of these guidelines and process for their development. Appropriate
changes in the dose reconstruction regulations should be made to address any
potential conflict between this Rule and 42 CFR 82 that could leave some
claimants ineligible for either individual dose reconstruction or special cohort
status.


Page 11307, Column 3, Section 83.9 (c)(2)(iv): Reword this section in order to
provide more clarity as follows: “A scientific or technical report published or
issued by a governmental agency or published in a peer-reviewed journal that
identifies dosimetry and related information and that is unavailable ...” Delete the
last part of the sentence beginning with the phrase “and also finds...”

Page 11307, Column 3, Section 83.9 (3) through the top of page 11308: This
portion of the section deals with exposure incidents and describes a process for
evaluating the information required for such incidents in the event that “NIOSH is
unable to obtain records or confirmation...” of the incident. The Board
recommends that NIOSH consider where the placement of this part of the section
should be within the rule, since it refers to information required after the petition
has been evaluated by NIOSH. As presently located, this portion could be
confusing to the petitioner.

Page 11308, Columns 2-3, Section 83.9 (3) (i) and (ii): These paragraphs require
either medical information or witness affidavits in the event that the exposure
incident cannot be confirmed. For the requirement that two employees who
witnessed the incident submit affidavits, the Board recommends that the petitioner
be counted as one of these two witnesses if the petitioner was an individual
employee who witnessed the incident..

The Board is also concerned that a petitioner may have difficulty finding
witnesses for an exposure incident that occurred many years ago. Witnesses may
no longer be living or may be difficult to identify or locate. In such cases, the
Board recommends that NIOSH offer the option for other parties to submit
confirmation of the incident in the absence of available eye witnesses or records.

Page 11308, Column 1, Section 83.11 (b): The Board is concerned that there is
no further appeal process for petitions that do not satisfy the relevant
requirements. Accordingly, the Board recommends that NIOSH explore possible
appeal mechanisms within the DHHS for such cases.

. Page 11308, Column 3, Section 83.13 (b)(1) (iii): For clarity, it is suggested that

the first sentence of this paragraph be reworded as follows: “In general, access to
personal dosimetry and area monitoring data is not a defining factor that must be
available to estimate the maximum radiation doses that could have been incurred
by any member of the class.”

. Page 11309, Column 1, Section 83.13 (b)(1)(iv): This paragraph refers to cases

where NIOSH finds that, while it is not feasible to estimate radiation doses, it may
be possible to determine that doses are limited to certain specific sites, thus
excluding certain other tissue-specific cancer sites from being considered as part
of an SEC class. While the Advisory Board understands that it may be
scientifically and theoretically possible for such a situation to exist, the Board is
also concerned about meeting the legislative intent of Congress on this matter and

we


CHAIRMAN;
Paul L. Ziemer, Ph.D.
Lafayette, Indiana

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

Richard L. Espinosa
Espanola, New Mexico

Michael H. Gibson
Franklin, Ohio

Mark A. Griffon
Salem, New Hampshire

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

Wanda I. Munn
Richland, Washington

Charles L. Owens
Paducah, Kentucky

Robert W. Presley
Clinton, Tennessee

Genevieve S. Roessler, Ph.D.

Elysian, Minnesota

STAFF:

EXECUTIVE SECRETARY:
Larry J. Elliott

Cincinnati, Ohio
c MANAG!

Cori B. Homer
Atlanta, Georgia

ADVISORY BOARD ON RADIATION AND WORKER HEALTH
4076 Columbia Parkway, MS: R-45
Cincinnati, Ohio 45226
(513/841-4498

May 5, 2003

The Honorable Tommy Thompson

Secretary, Department of Health and Human Services
200 Independence Avenue

HHH Building, Room 603G

Washington, D.C. 20201

Dear Secretary Thompson:

On August 22, 2002, the Advisory Board on Radiation and Worker
Health provided comments to you concerning the provisions of the
Department of Health and Human Services (DHHS) proposed rule
42 CFR, Part 83 entitled Procedures for Designating Classes of
Employees as Members of the Special Cohort Under the Energy
Employees Occupational Illness Compensation Program Act of
2000. In response to these comments, as well as comments by
other organizations and members of the public, the proposed rule
was extensively revised. On March 7, 2003, a new Notice of
Proposed Rulemaking was issued for public comment, and the
Advisory Board on Radiation and Worker Health is now
submitting its comments on the proposed rule as revised.

First, | would like to convey the thanks of the Advisory Board for
the responsiveness of the National Institute for Occupational
Safety and Health (NIOSH) staff members who prepared the
revision. The issues raised by the Board on the first Notice of
Proposed Rulemaking were addressed well in the revision

At its meeting on March 7, 2003, the Advisory Board reviewed the
changes that were made in the originally proposed rule, heard
comments from members of the general public on the proposed
rule, and discussed at length certain provision in the proposed rule.
Subsequently, the Advisory Board held three public conference
calls (on March 14, March 28, and May 1, 2003) to deliberate
further and hear additional public comment. As a result of these
meeting and deliberations, the Advisory Board has developed the
general and specific comments that are appended to this letter.


Page 2 —- The Honorable Tommy Thompson

The Advisory Board appreciates the willingness of DHHS and the NIOSH staff to
consider these comments in the drafting of the final 42 CFR 83 rule.

Sincerely,

ZEat ZX

Paul L. Ziemer, Ph.D., CHP
Chairman
Advisory Board on Radiation and Worker Health

Enclosure


Advisory Board on Radiation and Worker Health
May 5, 2003

Comments on 42 CFR Part 83, March 7, 2003: Procedure for Designating Classes of
Employees as Members of the Special Exposure Cohort Under the Energy
Employees Occupational Illness Compensation Program Act of 2000; Notice of
Proposed Rulemaking; Proposed Rule

1.

i)

Page 112296, Column 3, paragraph 2, last sentence: The statement “Hence, it
may be appropriate...” is confusing and should be rewritten.

Page 11303, Column 1, paragraph 2, sentence 2: Add the word “occupational”
after “sufficient” so as to read “If the employee had sufficient occupational
radiation exposure outside of his work experience as a member of the Cohort...”

Page 11305, Column 2, first line: Replace “this” with “these” so as to read
“*,..collect these data...”

Page 11306, Column 3, Section 83.5: Add the definition of “facility” (as found in
the regulation}; also, provide some clarification of the use of this term for the
SEC case. There are actually two definitions of “facility” in the legislation
(Subtitle B, Sections 3621 and 3626). The bill references work at a “facility” as
necessary for individual eligibility but does not limit “exposure” to a single
“facility” either in the dose reconstruction section or the SEC section.

For the purposes of this draft regulation, the Board recommends that “facility”
should be considered broadly (e.g., Los Alamos, Rocky Flats). Then the “class”
definition would be used to limit the class to those workers who worked in some
specific operation(s) at the facility and whose dose could not be reconstructed
with sufficient accuracy. If “facility” was defined to refer to specific buildings,
etc., NIOSH would have to spend considerable effort developing an inventory of
defined “facilities” at each DOE site and would have difficulty considering new
SEC classes for workers in operations that might have taken place in more than
one building or “facility” at a DOE site.

The Board also recommends that the regulation provide for the possibility of
combining SEC facilities (physical locations) for purposes of meeting the 250-day
requirement for eligibility as a member of a class.

Page 11307, Column 3, Section 83.9 (c)(2)(iii): Reword this section in order to
provide more clarity as follows: “A report form a health physicist or other
individual with expertise in dose reconstruction describing the limitations of DOE
or AWE records on radiation exposures at the facility, as relevant to the petition.
This report should specify the basis for believing the stated limitations might
prevent the completion of dose reconstructions for members of the class under
42CFR Part 82 and related NIOSH technical implementation guidelines; or”