In conclusion, the current scientific knowledge allows us to answer the question
whether it is likely a certain cancer can be caused by an exposure condition
without the presence of other disease or injury for either an internal or external
exposure scenario. This scientific knowledge should be used to specify the
exposure part of a Special Exposure Cohort in order to ensure fairness.

Unfairness can occur if persons with exposures meeting the dose reconstruction
criteria of 42CFR82, which disqualifies them for consideration as an SEC, have
doses and diseases that are not compensable because the probability of
causation does not establish “likelihood” while similarly exposed and diseased
persons in an SEC are compensated. Additionally, payment of compensation for
specified cancers that cannot meet the “likelihood” test of a 50% probability of
causation is not consistent with consensus science.

The Health Physics Society understands and appreciates the societal impetus
for the Energy Employees Occupational Illness Compensation Act of 2000 and
strives to support the Act while maintaining sound science in public policy. We
hope that the information provided in this letter is of use in this important effort.
Thank you for the opportunity to comment on the proposed rule.

Sincerely,

pt Coss

John R. Frazier, Ph.D., CHP
President


The specification of cancer sites in the definition of a Special Exposure
Cohort is just as relevant as specifying the facilities, or job functions in the
definition. The specified cancer sites are associated with the exposed
organs that justify the designation of an Exposure cohort.

The concept that certain cancers are not likely in the absence of other disease or
injury can be illustrated with an example. The Department of Energy's Office of
Oversight Environment, Safety, and Health issued an assessment of the
radiological hazards at the Paducah, Kentucky, gaseous diffusion plant in
February 2000 (Phase II Independent Investigation of the Paducah Gaseous
Diffusion Plant Environment, Safety, and Health Practices 1952 - 1990). The
report cited that the transuranic element Neptunium-237 was present at Paducah
from 1953 to 1957 without having been detected and that “The personnel
exposure pathway of principal concern was the inhalation of particulate material
contaminated with neptunium”. The behavior and resulting dose from inhalation
of neptunium is described in ICRP Publication 71 (Age-dependent Doses to
Members of the Public from Intake of Radionuclides: Part 4 Inhalation Dose
Coefficients; CD version).” Dose coefficients give the amount of dose to an
organ per quantity intake and are given for 25 specific organs.

Examining the dose coefficients (radiation dose per unit intake) for organ and
tissue doses from inhalation of Neptunium-237 shows that the coefficients range
by a factor of approximately 800 from the highest exposed organ, the bone
surface, to the lowest exposed organs. One of the organs with the lowest
radiation dose coefficient, which is associated with a high “natural” cancer rate, is
the thyroid. In a group of workers exposed to Neptunium-237, what is the
“likelihood” the neptunium would result in a thyroid cancer with no other cancers
or disease symptoms? The radiation dose necessary to result in the EEOICPA
definition of “more likely than not” (i.e., a 50% probability of causation (PC) at the
99% upper uncertainty level) for thyroid cancer depends on the specific
conditions of work, age, and exposure. Calculations of PC, using the NIOSH-
IREP for example, results in approximately 20 cSv or more required to reach the
compensable level. However, there may be scenarios that would result in a
lower radiation dose; so for demonstration purposes let's assume it would take
10 cSv to the thyroid to conclude the dose may have caused the thyroid cancer.
The dose coefficients tell us that any intake, which was presumably unmonitored
or not able to be estimated, that would deliver 10 cSv to the thyroid would also
deliver approximately 8000 cSv to the bone surface, and approximately 200 cSv
each to the red bone marrow, lungs, and liver. Probabilities of causation (PC’s)
for the radiation doses to these organs calculate to over 90% for each of them,
with bone cancer having a PC greater than 99%. Based on this it can be
concluded that it is very unlikely that an individual in a cohort exposed to
unmonitored airborne concentrations of Neptunium-237 would contract thyroid
cancer from this exposure before contracting bone cancer, leukemia, or liver
cancer.



Page 1 of 1

Miller, Diane M.

From: _ Keith Dinger [keith.dinger@verizon.net]

Sent: | Monday, May 05, 2003 3:10 PM

To: NIOCINDOCKET@CDC.GOV

Ce: Larry J. Elliott

Subject: Health Physics Society Comments on 42CFR83

On behalf of the Health Physics Society President, Dr. John Frazier, | am forwarding
comments by the Society on the proposed rule for implementing the Special Exposure Cohort
provisions of the Energy Employees Occupational Illness Compensation Program Act of 2000.

Please do not hesitate to contact me if you have any problems with, or questions regarding this
submittal.

Sincerely,

Keith H. Dinger, CHP

Congressional and Federal Agency Liaison
Health Physics Society

23 Prospect Street

Somersworth, NH 03878

Tel: (603) 692-4270

Fax: (603) 692-3760
keith.dinger@verizon.net

5/8/2003



HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

JOHN R. FRAZIER, Ph.D., CHP
President

Auxier & Associates, Inc.

Suite 1

May 6, 2003 9821 Cogdill Road
Knoxville, TN 37932
865-675-3669
jfrazier@auxier.com

CDC/NIOSH Docket Officer
CDC/NIOSH Docket Office

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

Cincinnati, Ohio 45226

Subject: Comments on the Proposed Rule on the Procedure for Designating
Classes of Employees as Members of the Special Exposure Cohort Under the
Energy Employees occupational Illness Compensation Program Act of 2000 as
presented in 68 FR 11294 through 11310, March 7, 2003

Dear Sir or Madam:

The Health Physics Society (the Society) is an independent, nonprofit scientific
organization of approximately 5600 professionals who specialize in radiation
safety. The Society, in its role as the professional radiation safety organization,
has specialized expertise in issues related to the implementation of the Energy
Employees Occupational Illness Compensation Program Act (EEOICPA). As the
current President of the Society, | am pleased to provide comments on the
proposed procedures, as contained in the referenced Federal Register, for
designating classes of employees as members of the Special Exposure Cohort
(SEC) under the Act. The Society appreciates the opportunity to participate in
this rulemaking.

On August 26, 2002, the Society provided comments on the first proposed rule
for designating classes of employees as members of the Special Exposure
Cohort, which was presented in 67 FR 42962 through 42973, June 25, 2002.
One of the Society recommendations in the August 26 letter was “that the
definition of a Special Exposure Cohort be specific to the types of specified
cancer that meet the ‘likelihood’ test for the potential exposures incurred by the
cohort”. This recommendation was based on the two fundamental principles
that: (1) the procedures are based upon the most current consensus scientific
knowledge; and, (2) that compensating members of a designated Special
Exposure Cohort be fair. The Society is pleased that the latest proposed rule
incorporates this recommendation.


Since publishing the latest proposed rule on March 7, 2003, it has become
apparent that there are some stakeholders, or individuals, that have taken issue
with the incorporation of the provision to allow specification of applicable cancer
sites in the definition of newly designated members of the Special Exposure
Cohort (see, for example, the discussion in the verbatim transcript of the meeting
of the Advisory Board on Radiation and Worker Health [ABRWH] held on March
7, 2003, in Cincinnati, Ohio, starting at page 183, line 18). The discussion raises
several issues about the interpretation of the enacting legislation, and one issue
related to the science that forms the basis for the provision, i.e., the extent of
scientific knowledge about the way radioactive materials, and their progeny (i.e.,
daughter products) are distributed and retained in the body once they have been
inhaled or ingested. The discussion at the March 7 meeting regarding the
scientific issue was based on an example presented to the ABRWH involving the
inhalation of radon. However, the question asked in the discussion could be
applicable to any radioactive material. The Society would like to provide an
expanded comment on the scientific basis for this provision, since our previous
letter and the example presented to the ABRWH did not address the details of
the basis.

The crux of the concern is the reasonable question whether it is known what
organs will be exposed following an intake (via inhalation or ingestion) of a
particular radioactive material. To address this question, it is essential to
emphasize that knowledge about which organs are exposed is insufficient
information for determining the likelihood of causation. How much radiation dose
the organs receive must also be determined, because the likelihood that an
exposure can cause a disease in an organ depends on the radiation dose
received (see, for example, the Society position statement “Compensation For
Diseases That Might Be Caused By Radiation Must Consider The Dose”,
http://hps.org/documents/Compensation.pdf). One of the principal tenets of
radiation toxicology is that biological effects occur where the radiation doses are
the greatest. This conclusion has been borne out in decades of experimental
animal studies and in the results of pertinent epidemiological studies.

The behavior of radioactive materials and their progeny in the body, and the
radiation dose to organs resulting from that behavior, is a fundamental part of
radiation toxicology, called internal dosimetry, a discipline of health physics that
has been studied extensively for over 50 years. Knowledge gained in the large
number of studies done since the early 1950's has resulted in a good
understanding of the behavior of radioactive materials and their progeny in the
body, and the resulting radiation doses to organs. This knowledge provides the
basis for specifying which diseases fit in the definition of a Special Exposure
Cohort. With this knowledge, it can be demonstrated that certain cancers are not
“likely” to result from intake of a specified radioactive material because the
radiation dose required to meet the “likelihood” test for those cancers is not
reasonable without the presence of other more likely radiogenic disease or injury,
which are naturally ranked by the magnitude of the radiation doses.