conditions in which dose reconstruction need not be refined if it is clear, through worst-case
assumptions, that it cannot be determined that the employee may have incurred a compensable
level of radiation dose. The dose at which this provision is implemented will need to be based
on the probability of causation calculation. Therefore, a dose below which the calculation is
not performed will need to be determined and promulgated. The Society recommends 0.1 Sv
(10 rem) for this dose level.

The Health Physics Society understands and appreciates the societal impetus of the
Energy Employees Occupational Illness Compensation Act of 2000. 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,

George Anastas, President

Enclosure



B. Discussion:

1. With regard to proposed fundamental principle IIl.A.1 above, the attached HPS
position statement “Compensation For Diseases That Might Be Caused By
Radiation Must Consider The Dose” sufficiently discusses this principle. This
principle is incorporated into the requirements in the EEOICA (Sec. 3623 (c) (3)
(A)) which states the “guidelines [for making the determination an individual
sustained a cancer in the performance of duty] shall be based on the radiation
dose received by the employee (or a group of employees performing similar
work) at such facility...” It should be noted that the HPS position statement
does not specifically state how an individual’s dose should be used in
consideration of determining if a cancer is occupationally related (i.e., how to
calculate or use a probability of causation) with the exception of the
establishment of a minimum value for calculating a probability, which is our
second fundamental principle.

2. With regard to proposed fundamental principle |I.A.2 above, the HPS position
statement on compensation states “there should be no compensation for
persons whose lifetime doses are less than approximately 0.1 Sv (10 rem).”
This position is explained in the following, which is taken from the position
statement. “This relationship of increasing likelihood of disease with increasing
dose has only been observed for doses greater than approximately 0.1 Sv. The
likelihood of radiation-induced disease below this level, if it exists at all, is so
small that it is not measurable, it is not a matter of scientific fact, and it can only
be estimated utilizing hypothetical mathematical dose-response models.”

The HPS position regarding a value below which compensation should
not be paid is based on its position statement titled “Radiation Risk In
Perspective.” A copy of this position statement is attached. This statement
contains the HPS position that “In accordance with current knowledge of
radiation health risks, the Health Physics Society recommends against
quantitative estimation of health risks below an individual dose of 5 rem in one
year or a lifetime dose of 10 rem in addition to background radiation.” The
position statement sufficiently discusses the rational for this position.

The EEOICA (Sec. 3623 (c) (3) (A)) refers to the use of the
radio-epidemiological tables published under the Orphan Drug Act in
determining the likelihood an individual's cancer is related to their employment.
These radio-epidemiological tables use the scientific knowledge regarding the
relationship of cancer induction and radiation exposure obtained from studies
where this relationship is observable, i.e., at doses greater than approximately
10 rem. They then extrapolate that relationship to doses below 10 rem where
the relationship cannot be observed, but where it can only be estimated using
hypothetical mathematical dose-response models. This extrapolation is an



|. GENERAL PROCESS

A.

1.

Proposed Fundamental Principles for the general process of developing guidelines and
promulgating regulations under the EEOICA:

Guidelines and regulations should be founded upon, and consistent with the most current
consensus scientific knowledge.

2. The Advisory Board on Radiation and Worker Health (the Board) should establish an

expert working committee for each of the technical issues under its jurisdiction (i.e.,
probability of causation, dose reconstruction, and Special Exposure Cohort designation)
to:

a. advise the Board on the most current consensus scientific knowledge related to their
technical area of responsibility, and

b. draft guidelines and regulations for Board action based on the current consensus
scientific knowledge and directions from the Board.

. Guidelines and regulations should be subject to an established independent peer review
process using expert organizations such as the National Academies.

4. Development of guidelines and promulgation of regulations should be accomplished in

an open, inclusive, and democratic process.

. Regulations should be established in accordance with the provisions of the
Administrative Procedures Act.

6. Guidelines and regulations should include provisions for periodic review of the current

consensus scientific knowledge to evaluate if the guidelines or regulations need to be
changed to reflect more current knowledge and to evaluate if previous claim decisions
need to be re-addressed.

7. Guidelines and regulations should include provisions for an appropriate appeals process

by claimants.


HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

Y

Founoen ses6_47

EXCERPTS FROM THE HEALTH PHYSICS SOCIETY’s

Comments and Input to the
National Institute for Occupational Safety and Health

On

Fundamental Principles for the Development of Guidelines and Promulgation of
Regulations

in accordance with the
Energy Employees Occupational Illness Compensation Act (EEOICA) of 2000

And
Executive Order 13179*

* The entire Comments and Input document was an enclosure to a letter
dated May 2, 2001, from Paul S. Rohwer to L. J. Elliott


3. With regard to proposed fundamental principle |.A.3 above, in January 2000 the
U. S. General Accounting Office (GAO) reported to the Senate Committee on
Veterans’ Affairs the results of their review of the validity of dose reconstruction
as a tool for determining veterans’ eligibility for benefits (GAO/HEHS-00-32). One
of the conclusions of this report was that “an independent review process . . .
could mitigate concerns about the integrity of the program.” We believe this
conclusion can be applied to each of the technical areas of responsibility for the
Board, i.e., probability of causation, dose reconstruction, and designation of
Special Exposure Cohorts. The independent review should be accomplished by
expert organizations charged with scientific reviews, such as the National
Academies.

4. With regard to proposed fundamental principle I.A.7 above, an appropriate
appeals process incorporates provisions to accomplish two purposes. These are
to: (1) accommodate consideration of information an aggrieved claimant feels
was not correct, or not correctly considered; and, (2) limit the process such that,
while protecting the rights and interests of all workers the administration and
processing is not overly burdensome on either the claimant or the compensation
system.

5. All other proposed fundamental principles above are considered to be self-
explanatory.

Il. PROBABILITY OF CAUSATION

A. Proposed Fundamental Principles for developing guidelines and promulgating
regulations to be used to assess the probability that a claimant’s cancer was
caused by his or her occupational exposure to radiation:

1. The probability that a claimant’s cancer was caused by his or her occupational
exposure to radiation must consider the person’s radiation dose.

2. Probability of causation determinations should only be made where the person’s
occupational exposure exceeds some minimum value below which there is no
known risk of cancer causation in populations exposed below this value. This
value should be approximately 0.1 Sv (10 rem).



Miller, Diane M.

From: Keith Dinger [dingerk@myapc.com]
Sent: Tuesday, December 04, 2001 9:31 AM
To: NIOCINDOCKET@CDC.GOV; OCAS@CDC.GOV
Subject: HPS Comments on 42 CFR 81
HPSComments.42C
FR81.doc

Dear Sir or Madam:

lam forwarding the attached document on behaif of the President of the Health Physics Society, George Anastas.
The document contains comments on the Guidelines for Determining the Probability of Causation Under the
Energy Employees Occupational Iliness Compensation Program Act as presented in 66 FR 50967 through 50978,
October 5, 2001.

Sincerely,

Keith H. Dinger
Past-President
Congressional Liaison
Health Physics Society
603 - 692 - 4270
kdinger@ttlc.net


example of a quantitative estimation of health risks below 10 rem with which the
HPS does not agree.

. In summary, incorporation of fundamental principles |.A.1, Il.A.1, and Il.A.2
resuits in a proposal that the probability of causation use the current scientific
knowledge of radiation health effects to calculate an individual’s probability of
causation using the individual’s dose, provided that dose is above an
established value below which compensation should not be provided. The
establishment of the minimum value for which compensation should be provided
could be refined using our scientific knowledge to establish an organ dose value
for each type of cancer, in lieu of a general “whole body equivalent” dose.
When an individual's dose is greater than the minimum value for compensation,
the HPS does not have a position on the specific method of calculating a
probability of causation, or how to use this calculation to determine if the dose
was “at least as likely as not” to have caused the cancer (EEOICA Sec. 3623
(b)). This should be the subject of study and recommendation by an expert
technical committee formed as recommended by proposed fundamental
principle 1.A.2.



B. Discussion:

1.

With regard to proposed fundamental principle I.A.1 above, the EEOICA (Sec.
3611 (b)) establishes that the purpose of the compensation program is to provide
for compensation of employees and, where applicable, survivors of employees
suffering from illnesses incurred by the employees in the performance of duty for
the Department of Energy and certain of its contractors and subcontractors. The
likelihood that a specific illness in an individual was incurred due to the
performance of their duty, as opposed to a non-occupational etiology, is a
determination that must be made by scientific and medical experts based on the
most current knowledge about the association of an individual’s workplace
exposure and the disease. Because cancer is such a prevalent disease, studies
of the association of workplace exposures as a cause of cancer in a workforce
are difficult to perform and are open to divergent interpretation of results. The
scientific community addresses the issue of differing study results through the
“peer review” process with “consensus scientific committee” determinations.
Therefore, the purpose of the EEOICA can only be achieved if current consensus
scientific knowledge is used as the foundation for the guidelines and regulations
implementing the Act. The Health Physics Society (HPS) has a formal position
statement titled “Compensation For Diseases That Might Be Caused By
Radiation Must Consider The Dose.” The last paragraph of the position
statement titled “Compensation Programs” provides the HPS position that “If the
reason [for a compensation program] is compensation for a disease or injury
caused by exposure to an agent, like radiation, then the best scientific and
medical knowledge, including dose-response considerations should support the
likelihood that the compensated disease could be caused by the measured or
reconstructed exposure” (emphasis added). A copy of the position statement is
attached.

With regard to proposed fundamental principle |.A.2 above, the EEOICA (Sec.
3624 (a) (2)) directs that the composition of the Board reflect a balance of
scientific, medical, and worker perspectives. This, with the fact the members are
at a Presidential appointment level, will result in a Board with members of diverse
levels and areas of expertise. In order for all members of the Board to have an
appreciation for the details of the scientific issues involved in each of the related
but different technical areas for which they have responsibility, they should have
the assistance of expert technical committees to do the “drafting and ground
work” for their review and subsequent “big picture” discussion and decision
making. The EEOICA (Sec. 3624 (c)) provides for a staff for the Board to
facilitate the work of the Board. Although staff is necessary, the expertise of
those developing the proposed guidelines and regulations that are considered by
the Board should be established through the appointment of expert working
committees appointed by the Board.



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

Section III. of the Notice of Proposed Rulemaking, 66 FR 50971, states that
substantive changes to NIOSH-IREP will be submitted to the Advisory Board on Radiation
and Worker Health. The Society has the same concern as given above that the Advisory
Board is not expected to be an expert scientific panel in the methods for calculating
probability of causation and that any substantive changes should also be subjected to
independent peer review by an expert scientific panel such as those formulated by the
National Academies. ‘

Provisions for review of changes to NIOSH-IREP should be included as a provision of
the rule itself.

3) Two additional comments not directly related to the generic topics.

Section IILF of the Notice of Proposed Rulemaking, 66 FR 50969, states that none of
the risk models explicitly accounts for exposure to other occupational, environmental, or
dietary carcinogens. . However, risk models do exist for occupational radiation exposure
received from employment not covered by the Act and from therapeutic exposures to ionizing
radiation, such as childhood x-ray treatment for tinea capitis or therapeutic radiation exposure
for a cancer. Individuals receiving radiation exposures from sources not covered by the Act
are at a greater risk of developing certain cancers than are the general public. This higher risk
should be used as the baseline risk for the individual in the probability of causation
calculation. Individuals usually know if they received occupational or therapeutic radiation
exposures not covered by the Act and those associated risks should, therefore, be able to be
ascertained. The proposed 42 CFR Part 81.5 should list occupational exposure in other than
42_ CFR 81 covered work and therapeutic radiation treatments as personal and medical
information to be provided to the Department of Labor. The calculation of probability of
causation should account for individual’s having an increased risk of cancer from these non-
covered radiation exposures.

The NRC subcommittee that reviewed the draft report of the NCI-CDC Working
Group expressed concern “about the problems with including so many cancer sites for which
radiation associations have not been well established.” The Society has the same concern.
This concern for the lack of a well-established association allowing for the quantification of
the radiation risk is the basis for recommendation II.A.2 in the enclosure to this letter. Section
ILA.2 states that compensation should not be awarded for doses at which it is not known
whether or not a risk exists. The establishment of a dose level below which compensation
calculations need not be performed is also consistent with provisions of the interim rule 42
CFR Part 82.10(k)(2). This provision of the dose reconstruction rule recognizes there will be


The proposed guidelines are to provide a method for determining whether individuals
who are covered by the Act and who have a diagnosed cancer may have sustained that cancer
from exposure to ionizing radiation in the performance of their duty at facilities covered by
the Act. The October 5, 2001, Federal Register Notice identified some generic topics for
comment. Society comments are provided within the context of some of these generic topics
followed by additional comments that do not directly relate to one of the generic questions.

1) Does the interim rule 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?

The Society does not think the methods for determining the probability of causation in
the proposed rule can be evaluated against current science at this time.

Society recommendations J.A.1, I.A.3, and L.A.6 in the enclosure relate to the issue of
using consensus scientific knowledge that is subjected to an established independent peer
review process using expert organizations such as the National Academies. The method
promulgated at 42 CFR 81 for calculating the probability of causation is by use of a computer
software program called the NIOSH Interactive RadioEpidemiological Program (NISOH-
IREP). The basic computer program, IREP, is being developed in conjunction with a National
Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) project to
update the 1985 NIH Radioepidemiological Tables. However, the IREP is still in draft form
and has not been published as a peer reviewed product. The National Research Council
(NRC) reviewed a draft report of the NCI-CDC Working Group to Revise the 1985 NIH
Radioepidemiological Tables. The NRC review identified a number of concerns,
recommendations, and suggestions regarding the proposed [REP and the underlying scientific
methods it uses. Since IREP is still in draft form it is not clear if, or how, it ultimately will
address the results of the NRC review.

Also of concern is the fact that the proposed rule includes provisions for NIOSH to
change the risk models in IREP as it feels they are needed, without provisions for appropriate
scientific peer review. Section III.H of the Notice of Proposed Rulemaking, 66 FR 50971,
states NIOSH-IREP will be reviewed by the Advisory Board on Radiation and Worker Health.
Discussion of Society recommendation I.A.2 of this letter’s enclosure identifies a concern that
since the members of the Advisory Board are selected to reflect a balance of scientific,
medical, and worker perspectives the Board should consist of members with diverse levels
and areas of expertise. Although this type of Board is well suited for general program
oversight and review, it is not expected to be a scientific panel expert in methods for
calculating probability of causation. Therefore, the computer program NISOH-IREP should
be subjected to independent peer review by an expert scientific panel such as those formulated
by the National Academies.



HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

FOUNDED 1956

oon

GEORGE ANASTAS, CHP
President
December 4, 2001 7007 Wyoming Blvd, NE: Suite F-2
Albuquerque, NM 87109

Tel: (505) 828-1003
CDC/NIOSH Docket Officer Fax: (503) 828-1062

CDC/NIOSH Docket Office Email: anastas@eeg.org
Robert A. Taft Laboratories, M/S C34

4676 Columbia Parkway

Cincinnati, Ohio 45226

Subject: Comments on the Notice of Proposed Rulemaking on Guidelines for Determining
the Probability of Causation Under the Energy Employees Occupational Illness Compensation
Program Act of 2000 as presented in 66 FR 50967 through 50978, October 5, 2001

Dear Sir or Madam:

The Health Physics Society (the Society) is an independent non-profit scientific
organization of approximately 6000 professionals who specialize in radiation safety. The
Society, in its role as the professional radiation safety organization, has some significant
comments on the implementation of the Energy Employees Occupational Illness
Compensation Program Act (the Act) and the guidelines for determining the probability of
causation used to implement the Act. The Society appreciates the opportunity to participate in
this rulemaking. As President of the Society, the following information is provided in
response to the Federal Register Notice soliciting comments from interested organizations.

On May 2, 2001, then Society President Paul S. Rohwer provided Mr. L. J. Elliott,
Acting Director of the National Institute of Occupation Safety and Health (NIOSH) Office of
Compensation Analysis and Support, extensive comments and recommendations regarding the
development of guidelines and promulgation of regulations covering: (1) probability of
causation; (2) dose reconstruction; and (3) designation of Special Exposure Cohorts. I am
enclosing, for reference, the recommendations and discussions of the items relating to
probability of causation that were in the attachment to the May 2, 2001, letter. If the
comments below do not refer to one of the HPS comments in the enclosure, the Society
considers the rule has appropriately addressed the comment or the comment is not pertinent to
this rule.