Comments of the Government Accountability Project Page 4 of 7

there is no reduction in effectiveness at causing cancer at low doses (indicating a DDREF of 1).

Epidemiological analyses of atomic bomb survivors do not support the conclusion that the
dose-response relationship for solid cancers departs from linearity (that is, the atomic bomb
survivor study does not support a DDREF greater than unity for solid cancers) (9, 10). Analyses
of leukemia among atomic bomb survivors have been interpreted as supporting a DDREF greater
than unity, although there is substantial uncertainty in estimates of the excess relative risk for
leukemia in the low dose range of the Life Span Study (LSS) data; and, when broader groups of
solid cancers are examined there is strong evidence of linearity. Evidence from studies of
chromosomal damage and animal experimentation (often evaluating non-cancer outcomes) is of
questionable relevance to radiation-induced cancer in humans. Epidemiological studies of
populations other than the Japanese atomic bomb survivors offer minimal support fora DDREF
greater than unity. Studies of breast cancers among tuberculosis patients who were exposed to
multiple chest fluoroscopies, for example, have been considered in evaluations of the effect
fractionation of low-LET radiation doses. There is no evidence in these studies of a reduction in
breast cancer risk with protracted exposure (11). Some have argued that a lack of a dose-related
excess of lung cancer among tuberculosis patients suggests a DDREF greater than unity for that
cause of death (12). However, necrosis and surgical removal of lung tissue among tuberculosis
patients (related to risk of lung cancer and duration of treatment) precludes any clear
interpretation of dose, or dose-rate, effects on lung cancer (13).

NIOSH also assumes in its model that it will be able to estimate on an annual basis the
amount of high LET dose and low LET dose and apply a different DDREF. First, historical data
will not be available in many cases to separate high LET doses from low LET doses, because the
radiation dose will be reported in Sv. Second, individuals will have internal doses of a
combination of high and low LET radionuclides with various biological half lives, and it will be
difficult, if not impossible, to assign values between high LET and low LET doses in these cases.
Finally, there simply may not be data to determine whether individuals encountered certain
exposures, such as the unmonitored neutron exposures (slow cooker effect) discovered by
NIOSH at Portsmouth from “freeze ups” in the uranium enrichment cascade. In this case, what
DDREF should be assigned, if the benefit of the doubt is to be given to workers?

Given the epidemiological findings of linearity in the atomic bomb survivor study, which is
used as the quantitative basis for the risk estimates in these tables, there is little support for the
decision to divide risk estimates by a factor of approximately 2, for purposes of compensation.
Further, there is great practical difficulty in obtaining sufficient data to segregate high LET from
low LET exposures. We therefore recommend that the DDREF should either be equal to 1.0, or
follow a distribution centered around 1.0 with associated uncertainty (e.g, 90% confidence
bounds at 0.67 — 1.50).


Comments of the Government Accountability Project Page 7 of 7

10. Little MP, Muirhead CR. Curvilinearity in the dose-response curve for cancer in Japanese atomic
bomb survivors. Environ Health Per 1997;105(Suppl 6):1505-9.

11. Boice JD, Jr., Land CE, Shore RE, Norman RE,Tokunaga M, Risk of breast cancer following
low dose radiation exposure. Radiology 1979; 131(3):589-97.

12. Howe GR. Lung cancer mortality between 1950 and 1987 after exposure to fractionated
moderate-dose-rate ionizing radiation in the Canadian fluoroscopy cohort study and a comparison
with lung cancer mortality in Atomic Bomb survivors study. Radiat Res 1995; 142(3):295-304.
13. Davis FG, Boice JD, Jr., Hrubec Z, Monson RR. Cancer mortality in a radiation exposed cohort
of Massachusetts tuberculosis patients. Cancer Research 1989; 49(21):6130-36.

14. Little MP, Charles MW. Bomb survivor selection and consequences for estimates of population
cancer risks. Health Phys 1990;59(6):765-75.

15. Pierce DA. Dealing with imprecision in dose estimates for analyses of the a-bomb survivor data.
In: Ron E, Hoffmann FO, eds. Uncertainties in radiation dosimetry and their impact on dose-
response analyses. Washington, DC: National Institutes of Health, 1997: 57-68.

16. Shimizu Y, Pierce DA, Preston DL, Mabuchi K. Studies of the mortality of atomic bomb
survivors. Report 12, part IJ. Noncancer mortality: 1950-1990. Radiat Res 1999;152(4):374-89.
17. Stewart AM, Kneale GW. A-bomb survivors: factors that may lead to a re-assessment of the
radiation hazard. Int J Epidemiol 2000;29(4):708-714.


Comments of the Government Accountability Project Page 3 of 7

assume an inverse relationship between age at exposure and sensitivity to radiation, in contrast to
recent occupational epidemiological studies that indicate the opposite pattern of association.
This trend in the IREP Model is derived from the atomic bomb survivor data, where data is used
from Japanese survivors. The Japanese exposure group comprises a range of ages from the very
young to the elderly. The young are especially vulnerable to ionizing radiation when compared
with adults; consequently, the slope tends to the negative.

With respect to workers compensation, we are examining the variation in sensitivity to the
effects of ionizing radiation only in adult ages (e.g., age 18+ years). Studies of U.S. radiation
workers suggest that older adults are more vulnerable to the cancer causing effects of ionizing
radiation than young adults (1). Several epidemiological studies (including worker studies)
suggest that sensitivity to the carcinogenic effects of radiation may increase in adulthood with
older ages at exposure (suggesting a non-linear trend in sensitivity across the lifespan) (2-6).
This age-sensitivity relationship is indicated at studies at multiple nuclear facilities in Oak Ridge,
Rocketdyne, Hanford, and encompasses all types of cancer. Moreover, most studies of other
chemical and physical hazards find a similar pattern of increasing vulnerability to hazards in later
life (7-8).

B. Section 81.11 Use of Uncertainty Analysis in NIOSH-IRE.

In the alternative, to the above proposal, NIOSH must, at a minimum, establish a factor that
accounts for the potential for increased sensitivity to radiation with increasing age at exposure for
U.S. nuclear workers.

The evidence from the occupational cohort studies of U.S. nuclear workers raises uncertainty,
if not serious doubts, about the validity of transporting risk estimates from the Life Span Study
(LSS) to U.S. nuclear worker populations specifically with respect to variation in radiation
effects with age at exposure. Expert opinion and recommendations from David Richardson at
the University of North Carolina call for the development of an adjustment factor to account for
uncertainty in risk estimates with age at exposure. This adjustment factor would allow for the
fact that there is greater radiosensitivity of nuclear workers to ionizing radiation at older ages of
exposure. Epidemiological literature for U.S. nuclear workers should be used to provide basis
for developing such an age sensitivity uncertainty factor for use in the IREP model.

C. The Use of a DDREF of 2 in the NIOSH IREP Model is not Supported in the most
Recent Literature and Should be Replaced with a DDREF of 1.

The NIOSH IREP model assumes that the effectiveness of radiation in causing cancers
decreases at low doses (except for an uncertainty factor included by NIOSH for high LET
exposures). For all other chronic exposures, the JIREP model specifies a dose and dose-rate
effectiveness factor (DDREF) with a value that is distributed around 2, even though analyses of
the atomic bomb survivor data (which are the quantitative basis for these tables) suggest that


Comments of the Government Accountability Project Page 5 of 7

D. Clarification is Needed with Respect to Whether the Model has been Corrected for a
“Healthy Survivor Effect” of the Atomic Bomb Survivor Cohort.

The model does not appear to account for underestimation of radiation dose response effect
in the atomic bomb survivor Life San Study due to the healthy survivor effect. The GAP
comments filed with NIOSH in June 2001 noted:

“A number of recent studies have concluded that there is convincing evidence that
mortality following the bombings of Hiroshima and Nagasaki left a select group
of healthy survivors. These analyses of radiation effects clearly pertain to a
highly select population. Furthermore, there is evidence that this selection was
dose-related, such that people in the high dose categories were more select than
people in lower dose categories. Overall mortality rates, for example, in the first
15 years after the bombing, are negatively associated with dose (15). Sucha
pattern is consistent with a healthy survivor effect in the cohort, and would lead to
a downward bias in radiation risk estimates (16,17)."

Furthermore, A-bomb survivors' exposures to fallout and irradiated structures is an additional
source of underestimation of dose-response in the LSS because these doses would have been
relatively more important for distant survivors (with low flash doses) than for survivors closest to
the hypocenter at the time of the bombing. We recommend that NIOSH develop and include a
correction factor for these sources of bias and associated uncertainty (14) as it appears that the
rulemaking and IREP do not address these issues.

E. Section 81.5 Use of Personal and Medical Information

NIOSH needs to allow for affidavits when specific medical data is not available to support a
claim.

Certain medical data, particularly for survivor claims, is not going to be available to all
claimants, because the covered worker’s physician is no longer in practice, hospitals have closed,
or records have been discarded because time frames for records retention have passed under state
law. For this reason, NIOSH should specify (1) the minimum records required to run the IREP
model; and (2) define which data can be supplied in affidavit form, as opposed to medical
records, when such records are not available from any sources.

F. Section 81.6 Use of Radiation Dose Information

NIOSH needs to define the range of uncertainty distributions for radiation dose that will be
used in determining probability of causation.

The Interim Draft Rule states that NIOSH will provide the Department of Labor with annual


1

Government Accountability Project
1612 K Street, NW ¢ Suite 400
Washington, DC 20006
202-408-0034 © fax: 202-408-9855

Email: gap1@erols.com * Website: www.whistleblower.org

January 17, 2002
VIA U.S. MAIL and E-MAIL 01-23-02P02:00 RCVD

Larry Elliott

Director, Office of Compensation Analysis and Support
National Institute for Occupational Safety and Health
4676 Columbia Parkway

Cincinnati OH 45226

Dear Mr. Elliott:

The Government Accountability Project respectfully submits the attached comments to
NIOSH's proposed rules "Methods for Radiation Dose Reconstruction Under the Energy
Employees Occupational Illness Compensation Program Act of 2000" (42 CFR Part 82)
and "Guidelines for Determining the Probability of Causation Under the Energy
Employees Occupational IlIness Compensation Program Act of 2000" (42 CFR Part 81).
We send these additional comments on each of the aforementioned rules with the
intention of supplementing and correcting the errors of our original comments. We are
grateful for your decision to reopen the comment period and allowing us the opportunity
to submit these additional comments.

The Energy Employees Occupational Illness Compensation Program Act (EEOICPA) is
groundbreaking legislation. EEOICPA reverses the Department of Energy's history of
denying compensation to the men and women who suffered injuries at a result of their
exposures in our nation's atomic weapons facilities. We are dedicated to ensure that the
administration and execution of the EEOICPA reflects its full congressional intent. It is
our hope that these comments are helpful in your deliberations and we look forward to
working with you in the future. If you have any questions or comments feel free to call
Richard Miller at (413) 536-3858 or Frank Morales at (202) 408-0034 ext. 128.

Sincerely,

Louis Clark,
Executive Director


Comments of the Government Accountability Project Page 6 of 7

dose estimates for each year in which a dose was incurred, together with uncertainty distributions
associated with each dose estimate. Please provide more prescriptive guidance in this rule with
respect to the range of estimates that will be used in the IREP. Will uncertainty estimates be
provided to 90%, 95% or 99% for annual radiation dose estimates? We note that the EEOICPA
applies the upper 99% confidence interval for determining the probability of causation. We
believe that the same criteria (upper 99% confidence interval) should be used for radiation dose
estimates when running IREP, except where the error, on average, is 6-10 times greater than the
mean estimate when calculating the committed effective dose equivalent. In these cases, the
workers should be placed, by NIOSH, in the Special Exposure Cohort because it is evident that it
is not feasible to estimate dose with sufficient accuracy.

G. Section 81.4 Definitions of Terms Used in this Rule

The Interim Draft Rule definition of a covered employee imposes an added requirement
beyond that prescribed by EEOICPA. It states: “For purposes of this rule, an individual who is
or was an employee of DOE, a DOE contractor or subcontractor, and for whom the DOL has
requested HHS to perform a dose reconstruction.”

The addition of the italicized text requiring DOL to request a dose reconstruction
precludes the possibility that a claimant, on behalf of a covered employee, could request a dose
reconstruction even though DOL fails to make such a request. NIOSH needs to clarify its
position on this matter.

Citations
1. Richardson DB, Wing S, Hoffman W. Cancer risk from low level ionizing radiation: the role
of age at exposure. Occupational Medicine: State of the Art Reviews 2001; (16(2): 191-218.
2. Richardson DB, Wing S. Radiation and mortality of workers at Oak Ridge National
Laboratory: positive associations for doses received at older ages. Environ Health Perspect
1999; 107(8):649-56.
3. Ritz B, Morgenstern H, Moncau J. Age at exposure modifies the effects of low-level ionizing
radiation on cancer mortality in an occupational cohort. Epidemiol 1999;10(2):135-40.
4. Ritz B. Radiation exposure and cancer mortality in uranium processing workers. Epidemiol
1999;10(5):531-8.
5. Wing S, Richardson DB, Wolf S, Mihlan G, Crawford-Brown D, Wood J. A case control
study of multiple myeloma at four nuclear facilities. Ann Epidemiol 2000;10(3):144-53.
6. Kneale GW, Stewart AM. Factors affecting recognition of cancer risks of nuclear workers.
Occup Environ Med 1995;52(8):515-23.
7. Kaplan GA, Haan MN, Wallace RB. Understanding changing risk factor associations with
increasing age in adults. Annual Review of Public Health 1999; 20:89-108
8. Cohen HJ. Biology of aging as related to cancer. Cancer 1994; 74(7 Suppl): 2092-2100.
9. Pierce DA, Preston DL. Radiation-related cancer risks at low doses among atomic bomb
survivors. Radiat Res 2000;154(2):178-86.


Government Accountability Project
1612 K Street, NW @ Suite 400
Washington, DC 20006
202-408-0034 ® fax: 202-408-9855

Email: gap1@erols.com * Website: www.whistleblower.org

01-23-02P02:00 RCVD

COMMENTS OF
THE GOVERNMENT ACCOUNTABILITY PROJECT

ON
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES' PROPOSED RULE

" GUIDELINES FOR DETERMINING THE PROBABILITY OF CAUSATION UNDER THE
ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT
OF 2000"

(42 CFR Part 81)

JANUARY 17, 2002
I. INTRODUCTION

A. Overview of the Government Accountability Project

The Government Accountability Project ("GAP") is a non-profit law firm and public interest
organization that represents the interests of workers who have suffered retaliation for raising
concerns about illegal or unethical conduct in the workplace. We advocate on behalf of groups
of workers interested in the enforcement of safety and health standards and specific acts of
individual whistleblowing. GAP has a nearly thirty-year history defending workers who raise
health and safety concerns, either to an enforcement agency or as part of filing a claim for
compensation. GAP has developed a program to track, educate, and advocate on issues related to
the implementation of the Energy Employees Occupational Illness Compensation Program Act
of 2000 ("EEOICPA"). GAP's Washington, D.C. office is located at 1612 K. St, NW, Suite 400,
Washington, D.C. 20006. We can also be reached via fax at (202) 408-9855 or e-mail at
gap1@erols.com.

B. Statement of Purpose

The purpose of these comments is to address our concerns about the National Institution for
Occupational Safety and Health ("NIOSH") proposed regulations "Guidelines for Determining
the Probability of Causation Under the Energy Employees Occupational IlIness Compensation
Program Act of 2000" (42 CFR Part 81). The EEOICPA is an essential first step to ensuring that


Comments of the Government Accountability Project Page 2 of 7

the men and women who dedicated their lives to the defense of our nation during the Cold War
are adequately and equitably compensated for the injuries they suffered during their employment
in Department of Energy ("DOE") and Department of Energy contractor facilities.

Section 3623 (c) of the EEOICPA requires the promulgation of guidelines for the purpose of
determining whether a cancer sustained in the performance of duty "was at least as likely as not
related to employment." Specifically, the EEOICPA states that such guidelines must:

(1) "be based on the radiation dose received by the employee... at such facility and
the upper 99 percent confidence interval of the probability of causation in the
radioepidemiological tables published under section 7(b) of the Orphan Drug Act;

(2) incorporate the methods established under subsection (d); and

(3) take into consideration the type of cancer, past health-related activities (such as
smoking), information on the risk of developing radiation-related cancer from
workplace exposure, and other relevant factors."

The President issued Executive Order 13179 "Providing Compensation to America's Nuclear
Weapons Workers," which delegated the authority under Section 3623 (c) to the Department of
Health and Human Services, which in return delegated their responsibility to NIOSH. The
Executive Order requires that NIOSH promulgate regulations establishing "guidelines, pursuant
to section 3623(c) of the [EEOICPA], to assess the likelihood that an individual with cancer
sustained the cancer in the performance of duty at a Department of Energy facility or an atomic
weapons employer facility, as defined by the [EEOICPA]."

Il. THE PROPOSED REGULATION "GUIDELINES FOR DETERMINING THE
PROBABILITY OF CAUSATION UNDER THE ENERGY EMPLOYEES
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000" (42 CFR
PART 81).

A. Section 81.10 Use of Cancer Risk Assessment Models in NIOSH IREP.

NIOSH should modify the risk models in Interactive Radioepidemiological Program
("IREP") to reflect the radiation exposure and disease experiences of workers covered under
EEOICPA which differ from experiences of the Japanese atomic bomb survivor cohort.

The IREP Model, as modified by NIOSH, fails to account for the fact that worker
epidemiology at Department of Energy nuclear weapons facilities indicates increasing sensitivity
to ionizing radiation with increasing age at exposure. NIOSH must modify the model for
purposes of worker compensation to correct assumption that sensitivity to radiation decreases
with age.

The National Cancer Institute Radioepidemiology tables and the NIOSH-IREP Model both