Miller, Diane M.

From: Schaeffer, Dennis CIV [Dennis.Schaeffer@dtra.mil]
Sent: Friday, August 23, 2002 2:37 PM
To: 'NIOCINDOCKET@CDC.GOV'
Subject: Comments on 42 CFR Part 83
42 CFR 83

comments.DOC
Defense Threat Reduction Agency provides the attached comments on proposed
rules for 42 CFR Part 83.

Mike Schaeffer

Program Manager

Nuclear Test Personnel Review Program

Technology Development Directorate <<42 CFR 83
comments.DOC>>


NIOSH has made significant suggestions toward the development of regulations
implementing the provisions of the EEOICPA that address additions to the Special
Exposure Cohort — in its proposed rule 42 CFR Part 83, presentations to the Advisory
Board for Radiation and Worker Health, and in public meetings. However, a major
difficulty has emerged in coordinating the interpretation of requirements for SEC
additions listed in EEOICPA Section 3626: “(1) it is not feasible to estimate with
sufficient accuracy the radiation dose that the class received; and (2) there is a reasonable
likelihood that such radiation dose may have endangered the health of members of the
class.” The obvious question is how endangerment is established without accurate doses.

NIOSH proposes a scheme on 42 CFR 83 “to establish an objective measure of health
with minimal use of subjective expert judgment... .fairly, transparently, and consistently
as possible.” However, because this scheme relies on a specific determination of dose, it
meets these criteria less well than does the following approach, which is based on the
principle, any dose that can be upper-bounded is sufficiently accurate, and its corollary,
any dose that cannot be upper-bounded is perforce a reasonably likely endangerment to
health. As applied to a worker’s eligible cancer(s) under the EEOICPA, these mean that
(1) if all dose(s) to the pertinent body organ(s) can be upper-bounded, then the provisions
of 42 CFR 81&82 are sufficient for processing the claim; and (2) any contribution to dose
that cannot be upper-bounded to a pertinent organ provides a technical basis for initiating
a class eligible for addition to the SEC. It is evident that ascertaining whether an upper-
bound dose does exist more straightforwardly and better meets NIOSH’s criteria than
does calculating a specific dose and the consequent risk.

The following are noted in conjunction with this approach:

(1) NIOSH has indicated its intent to proactively identify the membership of a class (here
the set of workers sharing an exposure with an unbounded contribution to dose to the
pertinent organ[s]), based on its commonality with a worker for whom a dose
reconstruction cannot be completed.

(2) The determination of an upper-bound dose, if feasible, and its application to a specific
claim in the absence of information for more accurately estimating the dose are consistent
with the provisions of 42 CFR 82, specifically parts 82.10, 82.12, 82.14, and 82.16.

(3) The retrospective endangerment of health (¢.g., for a specific cancer already incurred)
logically applies to a compensation program, whereas the prospective endangerment of
health (e.g., the incremental risk of incurring any cancer from future exposures) applies to
a worker safety program.

In most instances, including all that involve penetrating gamma radiation, an unbounded
dose to one organ will imply unbounded dose to all organs, thereby providing a clear and
simple application of the above principles. If, however, the unbounded component of
dose is solely due to radionuclides deposited in certain organs only, then only for these
organs are 42 CFR 81&82 not sufficient for processing a claim. In this situation, the
cancers associated with these organs only are logically relevant to a potential SEC class.
Such a differentiation based on cancer type is technically sound, unambiguous in its
application, fair to workers and the Government, and nowhere contraindicated by the
provisions of the EEOICPA. Note that the Health Physics Society provided NIOSH


suggestions in 2001 (published on the NIOSH/OCAS website) for implementation of the
EEOICPA, including Section 3626, that differentiated by cancer classes for potential
inclusion in the SEC. The approach proposed herein is in accordance with NIOSH’s 42
CFR 83 criteria and limits the situations in which this cancer dependence is germane.

On the basis of the above, three simple modifications to the proposed rule 42 CFR 83 are
recommended:

(1) include in part 83.5 a definition of “sufficiently accurate dose” and an expanded
definition of “endangered the health” in accord with the stated principles; and

(2) eliminate 83.12(b)(1), which through these principles is supplanted by (b)(2), in
which “estimated” becomes “estimated or upper-bounded.”

(3) add a brief description of the criteria that will be applied to decide whether or not an
upper-bounded dose can be estimated.