Comments on Guidelines for Probability of Causation, 12/04/01, p. 2

no mechanism for increasing the risk from DOE work from non-radiation exposures. In most
cases, this is an effect that is likely to be multiplicative because of differing biological
mechanisms [Chekoway, Pierce, Crawford-Brown. Research Methods in Occupational
Epidemiology. Oxford University Press, New York, pages 318-321, 1989]. Additionally, the
smoking contribution to risk unfairly uses an additive model where most epidemiologists apply
multiplicative models for smoking and radiation as discussed in detail by comments on this
proposed regulation made by the Center to Protect Workers’ Rights.

The current proposal is deficient in ignoring the difficulties faced by workers who have
incomplete dose records (similar to the problems faced by SEC Amchitka Test Site workers).
Particularly for sub-contractors and construction workers, important unexpected exposures
occurred in non-routine operations. Many of these exposures are unrecorded. Some workers
report removing their badges when entering radiation zones in order to avoid “burning out” their
badge. In short, for many workers the DOE records of radiation exposure (much less records of
other occupational carcinogen exposures) do not account for all of the risk faced by the worker.
HHS could address these deficiencies by actively opening additional special cohorts to workers
who can show they have work periods with likely exposure that are not a part of their dose
record.

With regard to the details of the proposed rules, the calculation of the probability of causation is
an involved model for which expert judgment must be applied in many steps. Based on the
preamble to the proposed rules, it appears that a process of peer review will be used to review the
assumptions made along the way. In order for this process to be equitable there should be a
document describing the peer review process, including a description of how others can
contribute to the peer review process.

The peer review process should not just include a review of the model and the method of
calculation of the probability of causation, but should also include a review of how the model is
applied to assure that it is being used in a correct and equitable manner. The criteria for
compensation involve looking at the 99" percentile of the probability of causation. Using an
extreme value such as the 99" percentile might mean that in the application of the program, most
of the people being compensated would be those whose doses were the most uncertain and not
those with the highest doses.


Miller, Diane M.

From: john abbotts [abbotts|@u.washington.edu]

Sent: Tuesday, December 04, 2001 4:27 PM

To: niocindocket@cdc.gov

Ce: bill griffith; timothy takaro

Subject: comments, guidelines for probability of causation
probcoms.doc

Dear NIOSH Docket Officers:
Please accept the attached Word file containing comments on the
guidelines for determining causation under the Energy Employees
Compensation Act
[RIN 0920-ZA01].
We are submitting these comments electronically to meet today's
deadline for submission. We also plan to send via postal mail a
paper copy, signed by Dr. Takaro, for the formal record.
We appreciate the opportunity to submit comments.
Yours truly,
John Abbotts

This message from:

John Abbotts

Department of Environmental Health
University of Washington

4225 Roosevelt Way NE, Suite 100
Seattle, WA 98105-6099

Phone: (206) 616-3439

FAX: (206) 616-4875

E-mail: abbottsj@u.washington.edu


December 4, 2001

NIOSH Docket Office
Robert A. Taft Laboratories
MIS C34

4676 Columbia Parkway
Cincinnati, OH 45226

email to: niocindocket@cdc.gov

Re: Comments on Guidelines for Determining the Probability of Causation Under the Energy
Employees Occupational Illness Compensation Program Act of 2000

RIN 0920-ZA01

Comments invited by 66 FR 50967, October 5, 2001

Dear NIOSH Docket Officers:

We appreciate the opportunity to comment on the subject proposed rulemaking. We also
appreciate the Institute's practice of making applicable documents available through its web
pages, which facilitates the ability to comment for persons geographically distant from
Washington, D.C. Please accept the attached written comments; contributors to these comments
are: Timothy Takaro, MD, MPH; William C Griffith, Ph.D; and John Abbotts, Ph.D. The
commenters are faculty (T.T.) and staff affiliated with the University of Washington, whose
research has been supported in part by DOE. However, responsibility for these comments lies
with the contributors as individuals. The views expressed have not been endorsed by the
University, the State of Washington, nor the Department of Energy. Please feel free to contact
me at 206-616-7458 on any matter related to these comments.

Sincerely,

[original signed]

Timothy K. Takaro, M.D., MPH
University of Washington

4225 Roosevelt Way NE

Suite 100

Seattle, Washington 98105


Comments on Guidelines for Determining the Probability of Causation Under the Energy
Employees Occupational Illness Compensation Program Act of 2000 (Compensation Act)
Comments invited by 66 FR 50967, October 5, 2001

We investigators and staff at the University of Washington have practical experience with the
occupational hazards and health concerns of the Hanford workforce through work with the U.S.
Department of Energy (DOE) Former Worker Medical Monitoring Program and other health
related projects at DOE's Hanford site. Radiation risk is a paramount concern for these workers.
With the enactment of the Compensation Act of 2000, there is a widespread expectation in this
population that those with cancers “on the list” are likely to be compensated for their cancer
through this Act. Based upon records of external dosimetry (PNNL databases REX and REMS) it
seems likely that very few Hanford workers with cancer will qualify for compensation based
upon the NIOSH Interactive Radio-Epidemiologic Program (IREP). This situation will produce
significant dissatisfaction with the Program and the Federal response to former Secretary
Richardson’s admission that work hazards at USDOE facilities during the cold war harmed the
workforce. The sense of injustice is further exacerbated by the Compensation Act's establishment
of Special Exposure Cohorts (SECs). Similar to the situation with U.S. Atomic Veterans,
members of SECs are not required to meet the strict radiation dose and causation components of
the Compensation Act. HHS should address this problem by the active establishment of
additional cohorts based upon the same criteria used for the SECs already defined.

Under the Compensation Act, employees meet requirements for the Special Exposure Cohort if
they were exposed to ionizing radiation during designated times at specified gaseous diffusion
plants, or as part of duties related to specified nuclear tests at Amchitka Island. The
Compensation Act allows the Secretary of HHS to designate additional SEC classes, and the
preamble to the proposed rule states that procedures for adding classes to the SEC are to be
developed by HHS (66 FR 50968).

The SEC provision seems to establish a two-tier system for compensation: Once an employee is
designated a member of the SEC, then compensation can be expected for specified cancers,
contracted after beginning employment with DOE or a DOE contractor. For other energy
employees, requirements appear more demanding: employee dose must be determined or
reconstructed, and then the probability of causation must be established. It seems likely under
this two-tier system that compensation will occur more frequently for workers designated as
members of the Special Exposure Cohort. We recognize that HHS is constrained by the
provisions of the law, but a likely outcome will be pressure on the Department to expand the
Special Exposure Cohort.

If the compensation system is to be viewed as equitable, then the procedures for adding classes to
the SEC should incorporate scientific criteria for causation no more stringent than those
applicable to the SEC classes already designated by the Compensation Act. We note that studies
sponsored and/or conducted by HHS/NIOSH could develop epidemiological data that may allow
comparisons between the current SEC classes and cohorts at other sites across the DOE complex.
The two-tier compensation system also suggests that the Department of Labor should maintain
records on the frequency of compensation for workers applying under the SEC or non-SEC
categories, and inform the Congress of any differences between those categories.

The compensation program should address all exposures during work for the USDOE that might
have contributed to a cancer, e.g. nickel or chromium for lung cancer or trichloroethylene for
liver cancer. While IREP reduces the radiation contribution in lung cancer for smoking, there is