Comments on Energy Employees Compensation Program Page 4

cancer from radioactive materials should be added to the risk of developing the same
cancer from non-radioactive materials. This would be a balanced approach.

Further, the risk of developing non-cancer diseases should also be factored into the risk.
How will the NIOSH-IREP software take this into account?

Radioactive Waste Management Associates


Comments on Energy Employees Compensation Program Page 3

chemicals that are inhaled along with radioactive materials. If these toxic chemicals also
induce cancer, the toxic chemical and radioactive risk should be added. How will the
NIOSH-IREP software take this into account?

Some materials, such as uranium, pose a heavy metal risk in addition to a radioactive
tisk. This is not necessarily a cancer risk, but it is a health risk that should be
compensated. In fact, for uranium, the heavy metal risk may be higher than the
radioactive risk. The Nuclear Regulatory Commission assigns a more restrictive limit air
concentration limit to uranium as a heavy metal than as a radioactive substance.

The toxic materials discussed above not only lead to cancer, but also to other diseases.
For example, uranium as a heavy metal is related to health effects such as increased death
rates due to the respiratory complications, kidney failure, and developmental and genetic
effects. Other chemicals to which DOE workers were exposed may be related to many
more diseases. Therefore, health effects other than cancer should also be taken into
account for DOE workers and their estates. How will the NIOSH-IREP software take
this into account?

Further, radiation is known to have hereditary effects. Hereditary effects are divided into
effects in utero, which are health effects to the unborn due to irradiation of the pregnant
mother, and genetic effects, which are effects of the offspring of a generation that
received a radiation dose before the children were conceived. Genetic effects can be
handed down many generations. The problem with these genetic effects is that they are
very difficult to quantify, even though on a qualitative basis, we know that they exist.
From this perspective, not only health effects in (ex)-DOE workers should be considered,
but also health effects in their children and grandchildren. How will NIOSH compensate
a worker or his estate for genetic effects?

81.10 Risk Assessment Models

The suggested changes to the risk models in IREP are welcomed. As more information is
obtained from the study of Japanese bomb survivors, it is clear that statistically
significant excess cancers are showing at lower dose levels. Further, recent data from
Japan show that the dose rate effectiveness factor has been thoroughly discredited. This
implies that the risk at lower dose rates and lower doses will generally be twice as great.
We encourage NIOSH to review the latest RERF findings.

We remain concerned that NIOSH will take into account the role of non-radiation risk
factors, such as smoking history, while also not taking into account toxic chemicals in the
workplace that also give rise to cancer. In our view, the risk of developing specific

Radioactive Waste Management Associates


Page 1 of 1

Miller, Diane M. _
From: Marvin Resnikoff [radwaste@rwma.com]

Sent: Thursday, November 08, 2001 11:04 AM

To: niocindocket@cdc.gov

Subject: Comments on Proposed 42 CFR Parts 81 and 82

Dear Sir/Madam:
We wish to submit the attached comments on proposed rules 42 CFR Parts 81 and 82, guidelines for

determining the probability of causation, and methods for radiation dose reconstruction, respectively.
Questions can be addressed to Marvin Resnikoff, 212-620-0526, or sent to this email address.

Marvin Resnikoff

11/8/2001


Comments on Regulations to implement the Energy Employees
Compensation Program: Methods for Radiation Dose Reconstruction,
and Guidelines for Determining the Probability of Causation

By
Beat Hintermann and Marvin Resnikoff, PhD
Radioactive Waste Management Associates
November 7, 2001

Since 1989, Radioactive Waste Management Associates has conducted dose
reconstruction studies on behalf of plaintiffs in personal injury law cases. These cases
involved disparate occupations such as uranium mining and milling, oil pipe cleaners, X-
ray workers, lens polishers, and residents near a thorium processing plant and uranium
mining and milling operations. In conducting this work, RWMA had to reconstruct
radiation doses and estimate the likelihood that radiation caused cancer or genetic effects.

General Comments

In general, the methodology proposed by CDC/NIOSH is appropriate and errs on the side
of the worker, but it places a high burden on the worker to prove his/her case. For certain
occupations at certain facilities that were clearly at risk, CDC/NIOSH should be the party
informing these past workers about the Energy Employees Compensation Program and.
sending compensation without any additional proof or effort on the worker’s part. Where
the basic data regarding air concentrations are lacking, the burden of proof should fall on
CDC/NIOSH; CDC/NIOSH should prove that the work area was safe. As the proposed
regulations are written, the burden is on workers to prove that he/she was injured, that is,
that the work area was unsafe. Not having the basic data should not be a reason for
denying compensation. Finally, for certain cancers and other diseases that are extremely
rare, it is not clear why HHS should require workers to provide proof or should calculate
radiation doses.

Specific Comments

Sec. 82.10 Dose Reconstruction Process

* Radioactive Waste Management Associates, 526 W. 26" St., Rm. 517, New York, NY 10001, Phone No.
212.620.0526, radwaste@rwma.com


Comments on Energy Employees Compensation Program Page 2

If data are not available to assess internal and external doses, under the proposed
regulations, this information will be passed to DOL who will deny compensation. This
holds whether the former worker has been heavily exposed or not, just whether the basic
data is available. This is unfair and a major defect in the proposed regulations. It is hard
for us to imagine a situation where a rough approximation of radiation dose, at least a
bounding dose, could not be calculated. This depends on the level of effort expended by
NIOSH.

Occasionally, the necessary information may be classified, or the Freedom of Information
Act office in the particular region may not release documents on a timely basis. It is not
unusual for FOIA requesters, especially the Oak Ridge office, to wait 18 months before
documents are released. Since these restrictions are imposed by the government, they
should not work to the worker’s disadvantage and loss of compensation. In cases upon
which we have worked, if the defendant withholds information, they are penalized.
Discovery must be unfettered.

Sec. 82.14 Information to be used

Under 82.14, NIOSH specifies the type of information that could be used in dose
reconstructions. In addition to employment information, NIOSH will use worker
monitoring data, internal monitoring data and monitoring program data. While the list of
data is quite broad, except for employment information, none of this data may be
available for some workers. In that case, rather than halt the evaluation process, we
recommend that NIOSH borrow information from comparable work environments. E.g.,
if air concentrations at a specific uranium mine are not known, then air concentrations at
another mine could be used, scaled according to radioactivity, and to tons per day. We
mention air concentrations, because this parameter is the most difficult to determine (air
volume samplers were not available in the early days) and may comprise the largest
component of a worker’s dose. If air concentrations for a specific work site are missing,
NIOSH may have to investigate a comparable industrial process.

Further, all radionuclides in the air, including trace contaminants, must be identified and
taken into account. E.g., radioactive particulates at the head end of gaseous diffusion
plants where uranium is converted to hexafluoride form, may consist of uranium with
trace concentrations of plutonium, neptunium and technetium. These trace
concentrations are important for dose estimation.

We are concerned that NIOSH is only considering radioactive materials, using ICRP dose
conversion factors. While we heartily approve of the use of ICRP-60, and encourage
other federal agencies to follow NIOSH’ lead, we encourage NIOSH to also include toxic

Radioactive Waste Management Associates