ADVISORY BOARD ON RADIAnON AND WORKER REALm

4676 columbia Parkway, MS: R-45

Cincinnati, ohio 45226

(513)841-4498

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August 22, 2002

CHAIRMAN:

P.ue L ZI.w.r. Ph.D.

Laf.yette. lndi8na

MEMBERS:

Henry A. Anderson. M.D.

Madison. Wisconsin

The Honorable Tommy O. Thompson

Secretary, Departme~t of Health and Hwnan Services

200 Independence Avenue

HHH Building, Room 6030

Washington, D.C. 20201

Anton;o Andr8de, PhD.

Los Alamos, New Mexico

Roy L DeHart. M.D.. M.P.H.

~shviU.. Tennes..

RJch8ld L Espinosa

Espanola. New Mexico

Dear Secretary Thompson:

During meetings held May 2-3, 2002, July 1-2,2002, and August

14-15,2002, the Advisory Board on Radiation and Worker Health

examined issues relevant to the provisions of the Department of

Health and Human Services (DHHS) proposed rule

42 CPR, 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.

Sally L Gadota, M.S., R.N., COHN-5

Oak Ridge, Tennessee

Mart A. Griffon

SaJ8n. New H8npshire

J..-s M. M..iuS, M.D.. PtLD.

Albany, New YoR

W.nd8 I. Munn

RJchland, W.shlngton

Robert w. Presley

Clinton. Tennessee

Genevieve S. Roessler, Ph.D.

EJy...n, Mlnnesot.

At the Board sessions, formal presentations were provided by

National Institute for Occupational (NIOSH) staff members

concerning the Special Exposure Cohort issues. In addition,

presentations were made by outside experts, including individuals

from the Department of Veterans Affairs. Members of the public

also provided valuable input on this matter.

STAFF:

EXE'ClmVE SECRETARY:

..any J. Elliott

Clncjnnad. OhIo

:DMMITTEE MANAGEMENT :

:ori B. Homer

AlJanta. Georgi8

Under the provisions of the President's Executive Order of

December 7, 2000, the Advisory Board has very specific

responsibilities on advising the Secretary, Department of Health

and Human Services. In accordance with those responsibilities, I

am pleased to provide the Advisory Board's comments and

recommendations concerning the proposed procedures set forth in

42 CFR, Part 83. These comments and recommendations are
Page 2 - The Honorable Tommy G. Thompson

summarized in Attachments 1 and 2. Attachment 1 provides general comments

on certain aspects of the proposed rule. Attachment 2 provides more specific

comments on particular sections of the proposed rule.

Please let me know if additional infonnation or clarification is needed.

Sincerely, "

~~~~-~ ~

Paul L. Ziemer, Ph.D., CHP

Chairman

Advisory Board on Radiation and Worker Health

Enclosures (2)

cc:

Members, Advisory Board on

Radiation and Worker Health
Attachment 1.

General Comments

Non-SEC Listed Cancers

The Board noted that there were a number of unresolved issues concerning how to handle

claimants who were part of a Special Exposure Cohort (SEC) class but who developed a

non-SEC listed cancer. The Board recommends that the National Institute for

Occupational Safety and Health (NIOSH) carefully review the proposed regulations to

ensure that these do not preclude appropriate handling of these cases. The Board also

recommends that NIOSH develop appropriate procedures to address situations where part

but not all of a claimant's dose history is included in a SEC class.

Health Endan2ennent

The Board members suggest that the proposed rule for determining whether a potential

SEC class meets the criterion of "health endangerment" is not adequate. In particular, the

proposed method for estimating whether the cohort met the criterion for "health

endangerment" is not adequately justified and could lead to arbitrary and unfair decisions.

The Board recommends that NIOSH consider other suitable criteria.

Dose Reconstruction Guidelines

The Board recommends that NIOSH clarify the criteria for determining that it was not

possible to complete an individual dose reconstl'\lction with sufficient accuracy. These

criteria should be more completely outlined in the preamble to the final rule in order to

assist potential SEC class applicants to understand the criteria that will be used for

evaluating an applicant for inclusion in any SEC designation. The Board also

recommends that NIOSH develop operational guidelines outlining the criteria. to include

time limits, for determining that the available data are not adequate for conducting

individual dose reconstruction. These guidelines should be reviewed by the Board. The

Board believes that these guidelines are necessary for ensuring consistency and fairness in

these important determinations.

Interim Final Rule

The Board recommends that DHHS consider issuing these regulations as an interim final

rule rather than a final rule. The former would allow later modifications to the rule

without necessarily going through the full rule making process. Given that some

elements of this rule (e.g., health endangerment criteria. how to handle SEC class

members with non-SEC listed cancers, etc.) have not been fully worked out and will need

funher development by NIOSH and review by the Board. this may be a prudent approach.

If issuing this rule as an interim final rule would inhibit the Secretary of DmiS from

certifying new SEC classes, then the Board would recommend that this option not be considered. . -
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Attachment 2.

Specific Comments

Section 83.1

The proposed rule states that "HHS will consider adding new classes of employees only in

response to petitions by or on behalf of such classes of employees. . .." This wording

gives the impression that the burden for adding new classes lies completely on the

individual employees. The Board believes that it would be beneficial if the rule made it

clear that NIOSH intends to be proactive in identi~ng and assisting employees who may

be in such categories to develop the appropriate petitions. Accordingly. we recommend

that a new statement be added to Section 83.1 that could read as follows:

"Because NIOSH itself may be in a better position to identify classes of

employees that may comprise special cohorts (based on its own findings from

collections of individual dose reconstruction efforts or from new findings that

result from site profiles), NIOSH intends to be diligent in identifying and

assisting employees who may be in such categories to develop the

. . . "

appropriate petitions.

The Advisory Board is also concerned that some individuals may misunderstand the

purpose and role of the Special Exposure Cohort. Although the language of the Rule

clearly states that it applies to individuals for whom doses cannot be estimated by the

completion of a dose reconstruction, it seems likely that some individuals may simply

regard this as a route for appealing a decision where a claim did not qualify for

compensation. Thus, the Board is suggesting that an additional statement be added in this

section that states explicitly that the purpose of the Rule is nQ1 to serve as an appeal for

those whose dose reconsttuctions did not lead to compensation.

Section 83.2

.. A cancer claimant whose dose reconstruction was completed but whose

claim did not qualify for compensation cannot use the procedures for

designating SEC classes as a route for appealing a decision. This does not

preclude appeals as provided for in Department of Labor rules. "
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Section 83.5

In item (c), in addition to the parameters specifi~ it is important to add an additional

parameter, namely that of a common time period for the work. The addition of the phrase

"during similar time periods" after "at the same DOE or A WE facility" would remedy

this matter.

Section 83.9

The Board recommends that NIOSH change the requirements for petitioning for SEC

class consideration to modify the proposed requirementhat "DOE or the AWE responded

indicating the records do not exist" in response to a request for records relevant to the

class petition. Obtaining such a response is not possible for most Atomic Weapons

Employers (A WE) facilities and may be difficult for some work at many DOE facilities.

Rather, the applicant should be required to have made a "good faith effort" to obtain such

records. Even this may be difficult for A WE facilities. The Board also recommends

adding a third element to this section indicating that the applicant may submit a

government or other published scientific research report indicating that such historical

records are not available for that facility.

Section 83.10

The wording of items (bX2), (bX3), and (bX4), infers the Advisory Board is directly

involved at an early stage in processes which should be DmlS (or NIOSH) staff

functions. This can be remedied by deleting the last sentence of item (b X2), deleting the

last sentence of item (b)(3), and deleting the last phrase of item (b)(4). Additionally, in

item (c) sentence I, insert the phrase "together with its evaluation plans" after the word

"evaluation" so as to read:

.. NIOSH will present petitions selected for evaluation, together with its

evaluation plans, to the Boardfor review."

Section 83.13

The Board is concerned that the language in this Section makes it appear that the Board's

role is ad judicatory -in nature, and the review of petitions by the Board may be regarded

as a fonnal hearing. See, for example, the language in paragraph 83.13 (b) concerning the

presentation of "evidence." We understand that the language of the Public Law does

specify certain responsibilities for the Board in terms of evaluating petitions for Special

Exposure Cohort status. At the same time, the Board's role is advisory to the Secretary

ofDHHS. Thus, we would recommend language that makes it clear that, while - -

petitioners will be invited to meetings where they can present pertinent information to the
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Board, the Board's report is simply one piece ofinfomlation that the Secretary will

consider in making a f1I18l decision on the petition.

Section 83.15

We assume that the intent of this Section is to provide the Secretary, DHHS with

flexibility in considering other factors (perhaps procedures or infonnation not even

thought of at the time of the rule-making) in reaching a fmal decision. However, insofar

as this statement opens the door for any number of arbitrary issues to be introduced into

the process, the Board is concerned that the'statement may be too open-ended. As a

minimum, perhaps it could be specified that the "other procedures" must not be in

conflict with the procedures established in the Rule.