claimant perceives the records and data to mean and how they are used in the dose
reconstruction.

Paragraph 82.10(k)(1): The dose reconstruction process needs to be segregated and isolated
from the PC application process. Otherwise, the claimant will be left with the belief that
doses are purposely reconstructed to be under the value needed for a claim award so as to
minimize the Government’s chances of having to pay a claim.

Paragraph 82.10(m) and 82.25: Measures should be described for handling a claimant who
will not sign off on the dose reconstruction. Like the veterans’ program, NIOSH should
elaborate on procedures for evaluating a dose reconstruction performed by a qualified expert
party engaged by the claimant to counter the Government prepared dose reconstruction.
Further, the procedures should include a mechanism for resolving or reconciling significant
differences in the two reconstructions and defining the final end point in the process.

Paragraph 82.14: The implication is the sources of information are bounded by the listing in
this paragraph. For example, there could be information pertinent to dose reconstruction
beyond the list in this paragraph.. There should be a general provision for allowing other
available information and historical documents relevant to exposure circumstances to be
taken into account.

Paragraph 82.18: There should be provisions for allowing or disallowing or for deciding the
relevancy of the results from a recently taken bioassay sample in the dose reconstruction
process. As for the veterans’ program, it should be pointed out that, even if air sampling data
are non-existent, an air concentration for internal dose deposition could possibly be derived.
Knowing the source term and isotopic content of the source term, an external dose can be
reconstructed from the contribution of the derived air concentration and then normalized to
results of available external dosimetry. In turn, the derived air concentration, after the
normalization, can be used to reconstruct the internal dose component. This process, used
for the veterans’ program, should also be included in the NIOSH program.

Paragraph 82.26: There should be clarification to the claimant that signing off on the
NIOSH prepared dose reconstruction does not imply agreement, only that all known and
available sources of information between the claimant and Government were collected.
There should be provisions for the situation when the claimant refuses to sign off on the
reconstruction no matter what the conditions are.

Paragraph 82.27: There needs to be a detailed description of the review process, including
what body or organization conducts the review, the professional background of individuals
concerned with the review, and the expected outcomes of the review.


Miller, Diane M.

From:
Sent:
To:

Ce:
Subject:

EEOICPA.doc

Schaeffer, Dennis CIV [Dennis.Schaeffer@dtra.mil]
Thursday, November 01, 2001 10:55 AM
‘NIOCINDOCKET@CDC.GOV'

Brittigan, Robert SES General Counsel
Comments on 42 CFR Part 82

NIOSH Docket Officer, attached are Defense Threat Reduction
Agency/Department of Defense comments collected thus far on the proposed
EEIOCPA Rules published in the Federal Register on 5 October 2001, pgs
50978ff. <<EEOICPA.doc>>

D. Michael Schaeffer

Program Manager/Senior Health Physicist
Nuclear Test Personnel Review Program
Technology Development Directorate
Defense Threat Reduction Agency

6801 Telegraph Road

Alexandria, VA 22310

(703) 325-2407

fax (703) 325-2954


Defense Threat Reduction Agency (DTRA)/Department of Defense (DoD) Comments on
Proposed Rules Being Issued under 42 CFR Part 82, Methods for Radiation Dose
Reconstruction Under the Energy Employees Occupational Illness
Compensation Program Act (EEOICPA) of 2000

A. General Comments:

It appears NIOSH has developed the dose reconstruction program for the EEOICPA on the
premise of only supporting compensation decisions. In section IIL. E. of the rule, the
discussion about balancing efficiency and accuracy makes it clear that reconstructed doses
likely would not be suitable for future epidemiological study, given the need to have a dataset
of consistently constructed and accurate doses with ranges of uncertainty. If the rule were
intended to provide doses to serve both purposes, then the principles for efficiency would
have to be abandoned to assure consistency. The rule should clarify NIOSH’s purpose in
building a dataset of doses and the attendant limitations if compensation is the prevailing

purpose.

In section III. F. in the discussion of differences between veterans’ and NIOSH’s dose
reconstruction programs, complexity is mentioned as a distinguishing difference along with
worker experiences. While we agree that work experience in a long term occupational
setting is a significant difference, complexity is not. Certainly, a veteran with participation
over 10 nuclear test operations, each involving different provisional radiation safety
organizations and evolving dosimetry monitoring science and practices presents both a
challenging, diverse, and complex situation. Complexity is not a distinguishing factor
between the programs.

In section III. F., NIOSH discusses the degree of intended interaction with claimants during
the information-gathering phase to be a principal difference in comparison to the veterans’
program. We believe that differences, if any, are small and that fact should be reflected in
the rulemaking. After receiving the dose reconstruction, a veteran may have iterative
contacts with both DTRA and VA to resolve questions, issues, and differences of opinion.
Unlike the NIOSH process, there is no prescribed limit to the number of iterations or appeals.

The essential difference between the veterans’ and NIOSH programs is knowing the
probability of causation (PC) threshold value needed for compensation before the dose
reconstruction is completed. NIOSH’s program ties the PC and dose reconstruction process
together. Although this tie-in is required in order to promote efficiency for dose
reconstruction, it will run the risk of increasing ill public opinion about NIOSH’s efforts.
Knowing the PC value required for compensation will create the impression that the
organization performing the dose reconstruction will be influenced to construct a low-sided
dose to deny claimants compensation. The veterans’ program has frequently received this
criticism from its claimants even though dose reconstructions are. completed by DTRA and
then provided to the Department of Veterans Affairs (VA) for application of the PC method.
We stress that each process is performed independently of the other and by two federal
agencies that do not interact on the processes. NIOSH should segregate the processes to



ensure the public will not lose confidence in the objectivity of the NIOSH program from its
inception.

. Specific Comments:

Paragraph II. B: There needs to be some description of specific factors that the Board will
use in conducting a verification of a dose reconstruction sample. For example, will the
Board be focused on methodology itself, its proper application, completeness of historical
documents and related research, or currency of scientific knowledge, or all of the above
factors? This part of the NIOSH process is crucial to gaining and maintaining public
confidence. There should be more detail and attention given to the verification process in the
description of the NIOSH program.

Paragraph 82.12: There should be examples given of circumstances for which doses cannot
be reconstructed. The minimum factors necessary for reconstructing a dose should be
determined and made evident for the NIOSH program.

Paragraph 82.2(a): There needs to be some discussion of how to evaluate the adequacy of
dosimetric data, concentrating for example on film badge emulsion damage, TLD glow curve
anomalies, imprecise bioassay results at low levels of detection, and possible falsification,
inadvertent mistranscription, or calculational errors involving dosimetric raw data.

Paragraph 82.5(e)(1): It would be helpful to also detail who is not in the covered
population, i.e. DoD atmospheric nuclear test workers, both military and civilian, DoD
workers in other specified radiation occupations, medical caregivers involved in diagnostic
radiation procedures. Otherwise, workers other than in the described population for the
NIOSH will apply needlessly for EEIOCPA benefits because it was not clear to potential
claimants that they do not fall under the programs. One exclusion is noted in the paragraph
for the Naval Reactors program. A more extensive list of excluded program would minimize
the number of extraneous claims being filed and sent to NIOSH for research.

Paragraph 82.10: We do not understand why exposures from medical procedures are being
covered under the NIOSH program. This proposed practice sets a precedent that radiation
exposures from routine, publicly accepted medical practices are compensable. If medical
procedure exposures are being quantified for the purposes of taking into account confounding
or contributing factors in assessing the connection between the occupational exposure only
and claimed disease, then a clarifying statement to that effect should be added.

Paragraph 82.10(h) and 82.15: There need to be criteria added for judging the adequacy
and completeness of the data and records. Having these criteria specified will enhance the
claimant’s confidence that a thorough search and analysis of the data and records were
performed to support the dose reconstruction. Also, the criteria should detail how differences
noted within document sources and data discrepancies are resolved as well as between
personal recollections and accounts by other workers, and available documents and data
records. There should be stepwise process for claimant to resolve differences in what the