Page 4 - Donald G. Shalhoub, Esq.

There also appears to be some confusion related to the OCAS-1 form provided with the draft
dose reconstruction report. NIOSH sends the OCAS-1 form to all claimants before returning
the case to DOL for decision. The form is not a waiver: signing the form does not mean that
the claimant agrees with the results of the dose reconstruction. The purpose of signing the
OCAS-1 form is to confirm that the claimant is not aware of additional relevant information
to share with NIOSH at the time the form is signed. NIOSH does not send the completed
dose reconstruction report to DOL for a final decision without the signed OCAS-1 form. It is
strongly encouraged that claimants sign and return the form within 60 days of receiving it.
According to the established procedures, if the form is not signed and retumed within 60 days,
and the claimant has not informed NIOSH that they have any additional information for dose
reconstruction or need more time to gather such information, NIOSH may administratively
close the dose reconstruction. This means the final dose reconstruction report will not be sent
to DOL for adjudication. If the claimant provides new information or a signed OCAS-1, the
dose reconstruction will be re-opened or submitted to DOL, respectively.

We hope the information and clarifications regarding Part B issues provided in this letter will
be of assistance in evaluating the concerns expressed by Part E claimants in your report.

John Howard, M.D.
Dirgttor


C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institute for

Occuptional Safety and Health
Centers for Disease Control

and Prevention (CDC)
200 Independence Avenue, SW
Washington, DC 20201

April 18, 2006

Donald G. Shalhoub. Esq.

Ombudsman for Part E of the Energy Employees
Occupational Illness Compensation Program Act
U.S. Department of Labor

200 Constitution Avenue, NW

Room N-2454

Washington, DC 20210

Dear Mr. Shalhoub:

This letter is in reference to your First Annual Report to Congress on Part E of the Energy
Employees Occupational Illness Compensation Program Act (EEOICPA) amended. pursuant
to 43 U.S.C. § 7385s-15(e) (“the Report”). In addition to documenting the number and types
of complaints. grievances and requests for assistance received by your office. and assessing
the most common difficulties encountered by claimants and potential claimants under Part FE,
the Report also raises several issues and comments related to U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention. National Institute for
Occupational Safety and Health (NIOSH) activities under Part B of EEOICPA. NIOSH
appreciates the opportunity to provide comments and clarification on Part B issues raised in
the Report.

Section IV of the Report summarizes comments received regarding general statutory
provisions of Part E. This Section indicates that two comments were received relative to Site
Profiles developed by NIOSH to assist with completing radiation dose reconstructions under
Part B. Section V of the Report summarizes comments received regarding the general
regulatory provisions of Part E. This Section indicates that 28 comments were received
concerning the dose reconstructions prepared by NIOSH for Part B claims.

In accordance with its responsibilities under EEOICPA. NIOSH has established through
public rulemaking the scientific foundation that supports the adjudication of cancer-related
claims. Radiation dose reconstruction is a scientific method used to estimate the radiation
dose received by the specific organ(s) in which a worker developed cancer, particularly when
radiation monitoring data are unavailable. incomplete, or of poor quality. Dose reconstruction
is specifically called for by EEOICPA, 42 U.S.C. § 7384n(d), and is a widely-accepted
technique used in the scientific community. NIOSH uses personal radiation exposure
monitoring information whenever possible. This may include film badge readings, medical x-
ray results, urine sample data and incident reports. If personal radiation exposure information



Page 2 — Donald G. Shalhoub, Esq.

is lacking or incomplete, NIOSH may also use co-worker data, environmental exposure
records, process records, technical documents, along with information obtained from
interviews with workers or survivors to estimate radiation exposures.

To assist in completing dose reconstructions for a site, NIOSH frequently develops a Site
Profile document for the site, a group of technical documents that describe the specific work
site. Site Profile documents are regularly updated as information becomes available and used
by health physicists to maintain consistency when completing dose reconstructions. Site
Profile documents describe the physical characteristics of the site, the work processes
employed, the types of material used, potential sources of radiation, and other details relevant
to reconstructing radiation exposures at the facility.

Another type of technical document that NIOSH develops to assist in dose reconstruction is a
Technical Information Bulletin (TIB), which contains information on specific technical issues
or procedures for estimating radiation exposure. TIBs can add to or supplement Site Profile
documents and may be site-specific or cover multiple sites. It is incorrect for the Report to
state that either of these documents. site profiles or TIBs, are developed to “cover gaps” in
claimants’ exposure histories.

EEOICPA specifically recognized that the process of estimating radiation doses would require
dealing with uncertainties and limited data and thus required the program to establish methods
for arriving at reasonable estimates of radiation dose in cases where employees were not
monitored, were monitored inadequately, or whose records are missing or incomplete. In
cases where radiation exposures in the workplace environment can not be fully characterized
based on available data, default values based on reasonable scientific assumptions are used as
substitutes. NIOSH addresses uncertainty about radiation dose levels by characterizing each
annual dose estimate with a probability distribution that accounts for the uncertainty of the
estimate. This information is used by DOL in the calculation of probability of causation. In
this way, claimants receive the benefit of the doubt in cases where the actual radiation dose
may have exceeded the best estimate calculated by NIOSH.

The Report states that claimants expressed concern about the use of Site Profile documents
for dose reconstructions for “roving” workers. The concern expressed was that Site Profile
documents covered only one portion of a facility and would thus result in unacceptably
compromised dose reconstructions, However, a Site Profile document for a facility includes
all information available to NIOSH that is relevant to dose reconstruction. If a worker moved
throughout a facility and was not monitored at some or any of the locations, the dose
reconstruction is completed assuming the worker consistently worked in the highest exposure
area within the facility. This approach ensures that claimants receive the benefit of the doubt
in cases where there is uncertainty.

The Report indicates that several claimants have suggested that the agency use a linear cancer
tisk model, such as the one outlined in the recent National Academy of Sciences study. rather


Page 3 - Donald G. Shalhoub, Esq.

than a threshold model for demonstrating the effects of radiation. The cancer risk models
used by NIOSH for dose reconstruction are and always have been linear models, not threshold
models.

The Report indicates that some claimants expressed concerns related to the burden of
retrieving employment and medical exposure records. To address this, DOL and NIOSH
systematically collect employment and radiation exposure information from the Department
of Energy (DOE), former employers and contractors, the Social Security Administration and
other sources. Most of the information used by NIOSH in dose reconstruction is gathered
from sources other than the claimants. Furthermore, the NIOSH records retrieval process
often identifies additional employment history and relevant medical or incident information
missing when a claim is provided to NIOSH by DOL. NIOSH provides all claimants the
opportunity to participate in a voluntary interview and supply information potentially relevant
to dose reconstruction, There is no penalty for not providing information and claimants are in
now way required to provide any documents as part of the dose reconstruction process.
Claimants are given the opportunity to verify that the information obtained and being used in
the dose reconstruction is both accurate and complete to the best of their knowledge.

The Report indicated that commenters were concerned that employment at multiple covered
facilities is not always reflected in the reports of dose reconstructions completed under Part B.
There are two potential reasons for some employment history provided by claimants to not be
included in the dose reconstruction estimate. This may occur if it is evident from a partial
dose estimate (a limited dose reconstruction that may not include evaluating exposure from all
covered facilities) that the estimated cumulative dose is sufficient to qualify the claimant for
compensation. Use of this efficiency process by NIOSH completing dose reconstructions
would account for the fact that employment at multiple covered facilities is not always
reflected in dose reconstructions. Another reason that some claimed employment may not be
included in NIOSH dose reconstructions is that DOL determines what is or is not covered
employment; therefore, NIOSH can only include employment that has been verified by DOL.
If there is new information that changes the covered employment determination, it is a matter
that DOL and the claimant would have to correct. If DOL certifies other employment as
being covered by the program, NIOSH would complete another dose reconstruction using the
new information. This often occurs with multiple cancers as well, the coverage
determinations by DOL being the basis of information used by NIOSH for dose
reconstructions.

The Report indicated that claimants have expressed concerns that information claimants
provided to NIOSH regarding work history is sometimes not accounted for in NIOSH dose
reconstructions and that documentation used to conduct the dose reconstruction is not
provided. This is an inaccurate perception. When NIOSH sends the final dose reconstruction
report for to DOL for final adjudication, NIOSH also sends the input file for the NIOSH-
Interactive RadioEpidemiological Program (IREP), any information used in developing the
dose reconstruction, copies of all correspondence related to the claim, any radiation exposure
information received from DOE, and the case file materials received from DOL.