TO: NIOSH DOCKET OFFICER DECEMBER 3, 2001
FROM: TRI-VALLEY CARES

be radiation, metal, or toxic chemical, that causes the work-related illness or death of
a nuclear employee, should be a part of this compensation program. Conversely, if
radiation at work causes illness but not cancer, the illness should also be covered.

The two examples below suggest modifications are needed to the policy and method of
notifying potential claimants.

1. We have been told by EEOICPA claimants, who receive retirement benefits from
LLNL as a result of their deceased spouses’ employment, that they were not notified
by the Lab about the EEOICPA. They, fortunately, found out about it through other
means. This indicates that there may be many people, with whom DOE nuclear
facilities have a direct relationship as a result of retirement or other compensation
matters, who have not submitted claims because they have not been informed about
this Act.

2. We have been informed by the daughter of a LLNL employee who died of cancer that
when her mother approached the Lab in the past to obtain her deceased husband’s
records because she believed his illness and death were work-related, she was told
that employee’s personnel files are shredded at death. Several other people who the
employee worked with had also died of cancer and the families had initiated a legal
action which they eventually abandoned because of their inability to obtain records.
These people are unwilling to file an EEOICPA claim because they feel it is useless.

This evidence suggests that there needs to be more assurance in communications to
potential claimants that their claims will be handled sympathetically, and unlike the past.
It also suggests that communications to DOE employees or former employees should be
handled by an agency other than DOE or accountability measures should be built into
communications so that it will be certain that the entire potential pool of claimants are
being notified appropriately.

Finally, rather than having compensation funds for this program compete with other
funding needs, DOE should set aside federal funds to pay workers’ claims. These funds
should be in addition to those currently allocated to contracts, and DOE should seek
supplemental appropriations for this purpose if necessary.

(3) Does the proposal appropriately and adequately address the need to ensure
procedures under this rule remain current with advances in radiation health
research?

It is now evident that low-energy beta particles are considerably more mutagenic per rad
or cGy of exposure than recognized in 1987 (Straume 1995; Gofman 1999) — perhaps by
a factor of four or five. As new knowledge such as this about radiation-induced iliness is


multiplicative approach for all cancers. The assumption that a multiplicative relative risk
model is valid has been argued in much of the literature on radiation effects.

Tri-Valley CAREs comments — Pg. 3

Furthermore, the multiplicative model would give the benefit of the doubt to the claimant
in a situation where there is scientific uncertainty

The assumption built into the current radioepidemiological tables is that the probability
that an adult worker’s cancer was caused by radiation tends to be lower for workers
exposed at older ages than younger ages. Recent occupational epidemiological studies,
however, indicate the opposite is true. Richardson and Hoffman report in the
Occupational Medicine: State of the Art Reviews 2001 that older adults are more
vulnerable to the cancer causing effects of ionizing radiation than young adults. The
work of Kaplan and Haan in the 1999 Annual Review of Public Health and the work of
Cohen in Cancer published in 1994 find a similar pattern of increasing vulnerability in
later life in most studies of other chemical and physical hazards.

We hope that the recommendations and suggestions above will influence how dose
reconstruction will be done, the assumptions built into the radioepidemiological tables,
and the IREP model. Without these revisions we believe that many sick nuclear workers
will be denied compensation in direct conflict with the goals and objectives of the Energy
Employees Occupational Injury Compensation Program Act.

We appreciate the opportunity to provide our comments.

Sincerely,

Marylia Kelley
Executive Director

MK:pao



TO: NIOSH DOCKET OFFICER DECEMBER 3, 2001
FROM: TRI-VALLEY CARES

Finally, regarding HHS role with DOE in appointing physicians panels, we hope that you
will support physicians panels use of a uniform standard to evaluate medical causality in
order to determine whether it is as likely as not that a worker’s medical condition was
caused, aggravated, or accelerated by the worker’s exposure to toxic substances at one or
more DOE, contractor, or subcontractor facility.

Your time and consideration are greatly appreciated. We provide these thoughts in the
spirit of cooperation and with a shared goal of providing a responsible program to DOE
employees, former employees, and their survivors who have become ill or died as a result
of their loyal and committed work in the nuclear weapons development industry for our

country.

If you have questions or need more information, please call at 925-443-7148.

Respectfully,

Marylia Kelley, Executive Director Inga Olson, Nuclear & Waste
Tri-Valley CAREs Program Associate
(Communities Against a Radioactive Tri-Valley CAREs
Environment) 2582 Old First Street

2582 Old First Street Livermore, CA 94550

Livermore, CA 94550

cc Senators Barbara Boxer and Dianne Feinstein
Representatives Ellen Tauscher, Barbara Lee, Fortney "Pete" Stark, Richard
Pombo, George Miller, and Robert Matsui
Secretary of Energy, Spencer Abraham
Deputy Secretary Robert G. Card
Acting Assistant Secretary Steven Cary


TO: NIOSH DOCKET OFFICER DECEMBER 3, 2001
FROM: TRI-VALLEY CARES

understood, it is important to ensure that no statute of limitations prevents claimants from
filing for compensation based on new information. Nor should a statute of limitation
prevent an employee from filing a claim, if that claimant must wait for information to be
declassified or for a delay due to filing for information under the Freedom of Information
Act.

On a related matter, we believe it is important to proactively develop a procedure for a
covered employee (or a member of his/her family) who was denied compensation after
dose reconstruction to later be included as a member of a new special exposure cohort, if
they meet requirements for inclusion. Also, a process needs to be created to evaluate and
recommend expanding the special exposure cohort after receiving input from a petitioner
or a recommendation from NIOSH.

A final issue we would like to address that is related to advances in radiation health
research applies to the children and grandchildren of nuclear workers. In our work at Tri-
Valley CAREs we are now beginning to see some children of nuclear workers who may
have health problems associated with the occupational exposure of their parents.

For this reason, we believe it is important to include language in the guidelines that takes
into account health and genetic effects to children and grandchildren of nuclear workers.

ADDITIONAL COMMENTS ABOUT HHS TECHNICAL AND
POLICYMAKING ROLES

HHS has a role in staffing the Advisory Board on Radiation and Worker Health. We are
concerned that this Board may be compromised by appointing members who financially,
politically, or in other ways have a conflict of interest in their relationship to DOE. We
hope that this issue will be investigated and that members with such conflicts will not
remain on the Board. Not only is avoiding conflict of interest issues paramount in the Act
and Executive Order, but a balance among the members was also emphasized. We would
like to see the preponderance of members from the medical and science fields vs
engineering. We also believe it is very important to have a strong contingent of affected
nuclear workers on the committee.

In addition, no individual or company should be placed in the position of reviewing, re-
estimating or needing to critique her/his current or former dosimetry work. If there is a
potential liability associated with radiation exposure or if the individual or company has
been retained by DOE or its contractors to serve as experts in ongoing litigation that
involves radiation, these individuals or companies should not receive contracts to perform
dose estimates for NIOSH. These two recommendations involving conflict of interest, in
our opinion, are consistent with the Federal Advisory Committee Act (FACA) and the
written intention of the law as passed by Congress and stated in the Executive Order of
the President.


critique their current or former radiation dosimetry work. If there is a potential liability
associated with radiation exposure or if the individual or company has been retained by
Tri-Valley CAREs comments — Pg. 2

the DOE or its contractors to serve as experts in ongoing litigation that involves radiation,
these individuals or companies should not receive contracts to perform dose estimates for
NIOSH.

The revised radioepidemiological tables and the supporting interactive computer program
(REP) should be modified to address weaknesses. The tables need to be tailored to
better account for the experiences of workers in the nuclear weapons complex. We
suggest tailoring tables to include results of epidemiological studies of workers so that the
tables reflect low-dose exposures typically received over a working lifetime and internal
exposure to alpha particles—the largest sources of radiation dose at many DOE sites.

There are assumptions built into the IREP model that need to be adjusted to truly reflect
the atomic bomb survivor data and the conditions at DOE nuclear facilities. One
assumption in the IREP model--the effectiveness of radiation at causing cancers decreases
at low doses—needs to be changed. In the analyses of the atomic bomb survivor data--
the quantitative basis for the tables—atomic bomb survivor data suggests that there is no
reduction in effectiveness at causing solid cancers at low doses. In addition, the
epidemiological tables are applied to workers who were exposed to alpha and neutron
radiation typical at the DOE facilities, not just gamma radiation, which was typically the
type of radiation exposure that atomic bomb survivors received. These incorrect
assumptions cause the IREP model to be programmed with a dose and dose-rate
effectiveness factor (DDREF) value that is distributed around 2 and which is too high for
solid cancers.

National Research Council studies published in the National Academy Press in 1999 of
exposure to alpha-radiation among miners suggest an inverse exposure rate effect (that is,
radiation effects were of larger magnitude when doses were accrued at lower does rates).
Also, an International Agency Research on cancer study published in 2000 concluded that
theré is no evidence of a reduction in effectiveness of neutrons at low dose or low dose
rates, and that effects may be larger for neutron doses accrued at lower rates.

A 1997 study by the National Council on Radiation Protection and Measurements
suggests that the simple inflation of all doses by a fixed correction factor is an inadequate
assumption about the distribution of measurement error. The study suggests that further
investigation of measurement techniques for evaluating the contribution of the neutron
component of dose in each city, and at varied distances, is needed to understand the error
distribution.

The decision to divide the lung cancer radiation risk estimate approximately in half for all
workers who ever smoked should be questioned. We recommend that NIOSH apply the



Miller, Diane M.

From: Inga Olson [olsoning@yahoo.com]

Sent: Tuesday, December 04, 2001 6:24 PM

To: NIOCINDOCKET@CDC.GOV

Subject: EEOICPA: Probability of Causation comments
NIOSH.doc Dose

Reconstruction2.doc : .
Attached find two documents: 1) comments on

Probability of Causation due today, and 2) comments on
dose reconstruction submitted earlier, but referenced
in today's comments.

Inga Olson

Tri-Valley CAREs (Communities Against a Radioactive
Environment)

925-443-7148

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October 31, 2001

NIOSH Docket Office,

Robert A. Taft Laboratories; M/S C34
4676 Columbia Parkway

Cincinnati, OH 45226

National Institute of Occupational Safety and Health
Re: Tri-Valley CAREs comments on EEOJCPA dose reconstruction

Tri-Valley CAREs (Communities Against a Radioactive Environment) was started in
1983 by a group of neighbors and laboratory workers of the Lawrence Livermore
National Laboratory. We wish to submit the following information as part of the
Department of Labor’s (DOL) formal comment period regarding how dose
reconstructions will be done.

We strongly advocate for the integration of stakeholder and worker input throughout all
stages of dose reconstruction because conditions in and between facilities can vary so
significantly, as can the interaction of radiation with the worker’s body. Worker and
stakeholder input can help to customize what is measured and how it is measured to
ensure a higher level of dose reconstruction accuracy as opposed to standardized
measurements based on inadequate data. For instance, worker input could describe how
their exposure was due to carrying “hot” materials on their left side, yet their dose badges
were always pinned to their right pocket:and, therefore, may not have recorded the
exposure.

We suggest that worker participation be coordinated through cooperation with the
union(s) and by using both one-on-one interviews and open meetings. Workers should be
able to provide an affidavit to NIOSH based on their knowledge and that is part of the
administrative record. Where significant data gaps exist for an individual, we hope that
NIOSH will group workers based on job categories, department or building information
to assist in dose estimation. Air monitoring data, dose badge re-reading, neutron
exposures, isotopes and ionizing radiations, radiation surveys, work practices, co-located
worker exposure data should all be considered in reconstructing the dose.

Past DOE conflict of interest problems would be detrimental if they resurface in
implementation of the current legislation. For that reason we recommend that individuals
or companies not be placed in the position of reviewing, re-estimating or needing to


TO: NIOSH DOCKET OFFICER DECEMBER 3, 2001
FROM: TRI-VALLEY CARES

(2) Does the proposal appropriately adapt compensation policy as it has been applied for
the compensation of veterans with radiation exposure from atomic bombs to
compensation policy for radiation-exposed nuclear weapons production workers?

Tri-Valley CAREs responded on October 31, 2001 to HHS’s request for comments
regarding “Dose Reconstruction.” We will reiterate two key points that were made in
more detail in that "Dose Reconstruction” document (which is attached for your
convenience), and that also respond to question two above:

1) The bias built into the dose reconstruction tables that cancer risk decreases with age
has been empirically rebuked, and the tables should be adjusted accordingly.

2) The dose and dose rate effectiveness factor (DDREF) should be 1 not 2.

Another point not made previously in the "Dose Reconstruction" document addresses the
determination of what is a “reasonable” dose. We concur with the suggestion made by
GAP in consultation with other experts that the IREP model should be modified to apply
the upper 95% or 99% confidence interval of the dose estimate instead of the average
(mean) dose. In addition, if the uncertainties are large (i.e., the 99% confidence interval is
6-10 times greater than the average), NIOSH could flag this claimant as a candidate for
the special exposure cohort. This will prevent claimants from being denied compensation
based on HHS’ inability to estimate dose. Furthermore, we support utilizing special
exposure cohorts for claimants with extremely rare cancers or other diseases, where their
employment was clearly the most likely causal factor in contracting their disease.

Next, with reference to question #2, we wish to add some recommendations concerning
policy issues related to workers’ eligibility for this program:

1. Nuclear weapons production cannot take place without support staff. The employees
of the nuclear laundries, i.e., the Interstate Nuclear Services in Pleasanton, CA are not
eligible for the federal compensation payment and medical care. These employees
should be made eligible.

2. Radiation does not stop at the fence line of the nuclear facility. Members of the
community that surround DOE facilities who have been made ill due to toxic
chemical and radiation releases should be eligible to apply for compensation under
this program.

3. Ifa person is murdered, whether it be by knife or gun, the weapon is incidental to the
deceased person or family members. Similarly, any hazardous substance, whether it


TO: NIOSH DOCKET OFFICER DECEMBER 3, 2001
FROM: TRI-VALLEY CARES

human epidemiological evidence against any threshold dose (Doody 2000), since the
estimated x-ray dose per exam was only 0.6 rad or cGy — a dose which causes an average
of only one primary ionization track per cell-nucleus. There is no lower dose, at the DNA
level, than one track. The United Nations Scientific Committee on the Effects of Atomic
Radiation (UNSCEAR 1993) also has contributed to work that disproves the belief that a
safe dose of ionizing radiation exists. This is also upheld by the National Academy of
Sciences BEIR V report. The research results cited above pose legitimate questions about
the validity of the currently accepted estimates that certain worker (and community)
radiation exposures are safe and whether the exposure levels that were monitored and
recorded at DOE facilities were adequate. We would like to see this body of knowledge
considered by NIOSH staff.

The studies also raise questions about accidents such as the 1965 and 1970 tritium
accidents at LLNL that released cumulatively 650,000 curies of tritium. Dr. John
Gofman, the former head and founder of LLNL’s biomedical department, estimated in
1987 that there was enough radiation released in these accidents to cause 60 deaths and
120 cancers. One problem is the employees (or community members) exposed to these
accidental releases would not have all worn film badges. Furthermore, because of
tritium’s half-life of 12 years, a good deal of it is still existent today. This is one example
of why we recommend a broad variety of methods for gathering information to determine
dose including but not limited to: a review of worker's records to determine which groups
of workers were at risk of high internal exposures and/or high lifetime exposures, use of
air monitoring data including determining source term composition where necessary, and
by inferring internal dose exposures from urine and lung-counting data. Further, we
would like to see an independent auditing and oversight committee established with a
strong scientific foundation and public and stakeholder credibility to address dose
reconstruction. We support the Government Accountability Project’s (GAP) and other
industry experts’ recommendation that NIOSH aggregate internal and external dose into
annual committed dose equivalents in the IREP model from the date of exposure through
the diagnosis of the illness.

We are concemed the decision to divide the lung cancer radiation estimate approximately
in half for all workers who ever smoked will disqualify employees suffering from
radiation-induced cancer. Even though radiation is not necessarily the only cause
contributing to cases of radiation-induced cancer, many workers’ cancers would not occur
in the absence of radiation.

In addition to radioactive hazards, it is clear from the nature of work done at nuclear
weapons plants that many workers are exposed to or are at risk of exposure to non-
radioactive hazardous materials such as acids, organic solvents, fluroine and fluorides,
and heavy metals. This information should be collected and included, where available,
under “other relevant factors” for HHS to consider as further justification to compensate
workers due to occupational illness.


December 4, 2001

NIOSH Docket Office

Robert A. Taft Laboratories; M/S C34
4676 Columbia Parkway

Cincinnati, OH 45226

NIOSH Docket Officer:

RE: Guidelines for Determining the Probability of Causation Under the Energy
Employees Occupational Illness Compensation Program Act (EEOICPA) of 2000; Notice
of Proposed Rulemaking

We appreciate the opportunity to provide input to NIOSH on the EEOICPA “Probability
of Causation” guidelines on behalf of Tri-Valley CAREs (Communities Against a
Radioactive Environment), an organization started in 1983 by a group of neighbors and
laboratory workers of the Lawrence Livermore National Laboratory (LLNL). We have a
Technical Assistance Grant from the Environmental Protection Agency and represent the
community’s point of view on cleanup issues at LLNL. In addition, we have been
providing assistance to current and former Department of Energy (DOE) employees,
contractors, and subcontractors in California who are applying for compensation under
the EEOICPA.

SPECIFIC COMMENTS ON “PROBABILITY OF CAUSATION” GUIDELINES
These comments are based on our direct experience with DOE workers, former workers,
and the communities surrounding DOE facilities. This information is generally organized
around the three questions provided in the Department of Health and Human Services
(HHS) Notice of Proposed Rulemaking.

(1) Does the proposal make appropriate use of current science and medicine for
evaluating and quantifying cancer risks for DOE workers exposed to ionizing
radiation in the performance of duty?

Human epidemiological evidence combined with track analysis has shown, by reasonable
standards of biomedical proof, that there is no threshold dose of ionizing radiation with
respect to induction of mutations (Gofman 1990). The same conclusion was reached by
Britain’s National Radiological Protection Board (NRPB 1995, p.68). Subsequently,
work at the Brookhaaven National Lab confirmed experimentally with DNA tests that
complex chromosomal and DNA injuries are inducible by a single primary track of low
LET radiation (Sutherland 2000). Meanwhile, a study on x-ray-induced breast cancer
conducted by the National Cancer Institute provided additional