Miller, Diane M.

—

From: mike schaeffer } .

Sent: Wednesday, December 05, 2001 7:21 PM

To: NIOCINDOCKET@CDC.GOV

Ce: dennis.schaeffer@dtra.mil

Subject: Comments on 42 CFR part 81 from Deapartment of Defense
PCcomment.doc

Attached is a corrected copy of the comments provide by Department of
Defense on 12/4/01. Please substitute the attached corrected copy for
the for the comments provided earlier. Pls confirm timely receipt.

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 22310-3398

(703) 325-2407

fax (703) 325-2954



COMMENTS PROVIDED BY DEPARTMENT OF DEFENSE ON THE PROPOSED
RULEMAKING UNDER 42 CFR PART 81 - GUIDELINES FOR DETERMINING THE
PROBABILITY OF CAUSATION UNDER THE EEOICPA ACT OF 2000

1. The National Institute of Occupational Safety and
Health (NIOSH) plans to implement a modified version of the
Interactive Radio-Epidemiological Program (IREP) to calculate
pc. The IREP acts as a “black box”, where details of the
program, the assumptions it makes, and the biases it uses are
hidden from the user. This lack of detail prevents proper
evaluation of the PC. The NIOSH-IREP software should be revised
to output the bases for a calculated PC and the associated data.

2. NIOSH intends to modify IREP to account for different
relative biological effectiveness distributions according to
neutron doses of various energies. It is not evident how energy
correction will occur based solely on exposure records and
without an understanding of the source.

3. The proposed rule makes a note several times
throughout the register that non-radiogenic cancers are to be
included in the proposed guidelines. As a National Research
Council (2000) report notes (commenting on the National Cancer
Institute Working Group's efforts to update the 1985
Radioepidemiological Tables), for cancers lacking documentation
of a specific dose-response pattern, compensation may be awarded
under dubious conditions of causation while a scientifically
stronger case with narrower confidence would fail to award.

4. The inclusion of dose from medical radiographs that
are performed as a condition of employment in PC calculations
should not be performed. The American College of Radiology has
stated that radio-epidemiological tables should not be applied
to cases involving medical irradiation. Additionally, if
radiograph procedures were prescribed to diagnose or screen for
a disease, they represent a positive benefit-risk judgement for
the patient.

5. The proposed rulemaking requires the Department of
Labor to include benign neoplasms and carcinoma in situ to be
malignant for the purposes of calculating a PC. These
conditions can be attributed to many more causes than are
covered by IREP.

6. The proposed rulemaking states that changes to the
NIOSH-IREP can be made in the future at NIOSH’s discretion. The
rule should state that revisions to the NIOSH-IREP should be put



out for public comment. The revision should be based on peer-
reviewed studies that have the support of the scientific
community.

7. The proposed rulemaking states that determination of
whether a cancer was "at least as likely as not" (probability of
causation (PC) of 0.5) caused by a radiation dose is based on an
upper 99 percent "confidence interval". This scheme in effect
means that the doses qualifying a person for a claim could in
some cases be up to an order of magnitude less than the doses
corresponding to the actual PC value of 0.5. The rule needs to
recognize that the actual compensation decision threshold based
on this confidence interval is much in the claimant's favor. A
graphical depiction of the actual scheme used to make a claims
decision should be provided in the final rule.

8. The rulemaking proposes to use uncertainty analysis
for PC estimates, taking into account the uncertainties in the
distribution of PC at 0.5 and in the individual measurements of
dose. The rulemaking does not describe the methodology for how
these sources of uncertainty interact or are taken into account
in the process of computing the PC. The rulemaking should
include a discussion of the methodology used to combine the
sources of uncertainty and how they influence the PC estimate.
The IREP software does not provide a detailed understanding of
how the various sources uncertainties are handled.