B. Discussion:

1. With regard to proposed fundamental principle IV.A.1 above, it is a
matter of scientific fact that the likelihood a specific cancer is associated
with an individual's exposure is dependent on the individual's dose.
This fact is discussed in some detail in the attached HPS position
statement on compensation. Therefore, the conditions existent for an
entire class of individuals to be designated as a Special Exposure
Cohort, such that the dose to none of the individuals in the class is
considered in the determination of their qualification for compensation,
requires those conditions to be extraordinary.

2. With regard to proposed fundamental principle IV.A.2 above, the
EEOICA (Sec. 3626 (b) (1)) establishes that a condition that can justify
designation of a Special Exposure Cohort is if it is determined that “it is
Not feasible to estimate with sufficient accuracy the radiation dose that
the class received.” Doses that are in a range that can not affect the
decision to compensate for a disease do not need to be known with any
accuracy. That is, if a screening dose reconstruction concludes the
dose to a class of workers is unlikely to be able to be estimated
accurately, but that it is not likely the doses could approach a level that
would be compensable, the class should not be eligible for designation
as a Special Exposure Cohort under this provision of the EEOICA.
Therefore, the only conditions that should be considered as qualifying
for this provision are those doses for which the inability to provide an
estimate with a realistic dose range could possibly be in the range of
compensable doses.

3. With regard to proposed fundamental principle IV.A.3, since most
Department of Energy facilities covered by the EEOICA are relatively
large facilities with processes and work assignments varying in
complexity and type, it is not expected that the two conditions given in
the EEOICA (Sec. 3626 (b)) would exist for all employees at one facility.
For example, an historical exposure assessment may reveal a work
assignment such as cleaning out radioactive dust collection bags
without respirators could be expected to result in a compensable dose
to all that did that assignment over some determined amount of time.
However, it is not logical to think other work assignments, such as
clerical personnel, would also be appropriate to include in the class of
workers.

Similarly, since each type of cancer has a different radio-
sensitivity, or dose response, the compensable dose under a probability
of causation calculation will differ. Therefore, the criteria that the doses
for the entire class are likely to be compensable will be expected to
differ by disease.

12


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.

3. With regard to proposed fundamental principle 1.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 !.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.

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


conditions. However, if a 42CFR83.12(b)(1)(ii) evaluation were performed for all
specified cancers, it could demonstrate that other organs do not have “a
reasonable likelihood” of causation by the exposure.

Compensating persons with occurrences of these specified cancers that
do not meet the “likelihood” test is neither fair nor scientific.

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, this procedure could result in
an SEC being established due to a large uncertainty associated with a rare
cancer that then results in frequent payments to the SEC claimants that develop
commonly occurring cancers that do not otherwise meet the “likelihood” test.
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.

| note that the proposed procedures do appropriately provide for the definition of
an SEC to include specification of things such as the period of employment, job
titles, job duties, job locations, and the existence of an unmonitored exposure
incident. For consistency, the procedures should also provide for the inclusion of
these and other important factors, such as specified cancers that meet the
“likelihood” test, leading to the SEC classification. Inclusion of the specified
cancers applicable to a particular SEC also eliminates the need to have a special
dose averaging procedure, as explained in footnote 6 of §83.12(b)(1)(ii), if the
most radiogenic cancer is leukemia. Since the threshold dose for the most
radiogenic solid tumor will be higher than that for leukemia, this averaging
procedure could be unfair if potential exposures to members of the SEC were as
high as the leukemia threshold but not as high as the “averaged” threshold.

The Health Physics Society recommends 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.

The rule should make it clear that a determination by NIOSH that a dose
reconstruction could not be completed for an individual includes the
determination that a worst-case scenario could not be constructed to
demonstrate the employee did not incur a compensable level of radiation
dose.

A key element to the procedure for designating additional members as an SEC is
a report produced by NIOSH under 42CFR82.12 notifying the petitioner(s) that
NIOSH attempted and could not complete a dose reconstruction for the
individual. An expected reason for not being able to complete a dose
reconstruction is the lack of dosimetry, work, and exposure records, which can


Therefore, designation of Special Exposure Cohorts should not
be applied to entire facilities or entire classes of disease, i.e., all
cancers.

4. With regard to proposed fundamental principle IV.A.4 above, the

Special Exposure Cohorts established in the EEOICA (Sec. 3621 (14))
were defined by legislative edict without benefit of the guidelines and
regulations that will be established for designation of additional classes
of workers in the future. Therefore, these Special Exposure Cohorts
should not be considered as providing precedence for establishing
guidelines and regulations for future designations.

The HPS recommends that once the Special Exposure Cohort
guidelines and regulations are established by the Board, the EEOICA
designated Special Exposure Cohorts be re-evaluated to determine if
their designation should be changed in some way to provide
consistency with potential future designations.

13


work. If the individual is screened in with a significantly high dose such
that the probability of causation calculations leave little doubt the test for
“at least as likely as not’ will be met, then further dose reconstruction is
not warranted. Greater detail and effort in dose reconstruction only
needs to be done for those individuals with a screening dose close to
the minimum compensable dose, or for whom the probability of
causation calculation is close to the compensation value. For these
individuals, further dose reconstruction techniques, such as refinement
of the work history, use of advanced technology techniques, etc., should
be employed to get the “most likely” dose estimate. The screening
assessment inherently requires the application of professional
judgement, and is an item appropriate for the independent review
recommended in proposed fundamental principle |.A.3 and the appeals
Process recommended in proposed fundamental principle |.A.7.

. With regard to proposed fundamental principle III.A.3 above, there are
two major areas of uncertainty that can be factored into a calculation of
the probability of causation, one associated with the individual’s dose
and one associated with the risk factor used in the probability of
causation calculation. The EEOICA (Sec. 3623 (c)(3)(A)) has
established guidance on the uncertainty associated with the risk factor,
i.e., use of the upper 99 percent confidence level of the calculation.
However, the uncertainty associated with a dose reconstruction is not
subject to an uncertainty calculation like that for the probability of
causation as provided in the radio-epidemiological tables. The
uncertainty of a specific individual’s dose reconstruction can only be
estimated by the radiation professionals performing the dose
reconstruction itself. As discussed above, the rigor with which an
individual dose reconstruction is performed will be dependent on the
estimated dose in relation to decision points imbedded in the probability
of causation calculation. The closer an estimated dose is to a decision
point, i.e., a screen in/screen out or a compensate/not compensate
point, the more the effort should be made to estimate the “realistic”
uncertainty of the dose estimate. A “maximum realistic” dose estimate
should be estimated and used as a point estimate of dose for the
remainder of the probability of causation determination. The estimation
of a “maximum realistic” dose inherently requires the application of
professional judgement, and is an item appropriate for the independent
review recommended in proposed fundamental principle |.A.3 and the
appeals process recommended in proposed fundamental principle 1.A.7.

. With regard to proposed fundamental principle IIl.A.4 above, guidelines
for performing dose reconstruction should be developed by an expert
technical committee as recommended in proposed fundamental
principle !.A.2. These guidelines should address the standard methods

10


The scope of the three tasks covered by your request is extensive and the time to
develop the comments and input, relatively short. In developing our comments
and input, we felt it essential to relay to you some fundamental principles we feel
are important to be incorporated into the guidelines and regulations as they are
developed. The enclosure lists proposed fundamental principles in each area with
some discussion as appropriate. We hope you find this approach to be helpful at
this stage of the process.

The comments and input contained in this letter and enclosed material are based on
approved positions of the HPS, which are referenced where appropriate. In
addition, these comments and input have been approved by the HPS Board of
Directors and, as such, can be considered representative of the general membership
of the Society, but not necessarily representative of any one member’s thoughts or
opinions.

Once again, thank you for this opportunity. The HPS has one interest in this
process, i.e., the use of sound science in the formulation of public policy. I hope
NIOSH and you will continue to see and use the HPS as a resource for assistance
in this important initiative.

Sincerely,

add Rahuer’

Paul S. Rohwer, Ph.D., CHP

Enclosures


Ce
_ COMPENSATION FOR DISEASES THAT
& % MIGHT BE CAUSED BY RADIATION
As)
Y Bi 7
Woot

MUST CONSIDER THE DOSE

FOUNDED 1958

POSITION STATEMENT OF THE
HEALTH HEALTH PHYSICS SOCIETY*

PHYSICS
SOCIETY Adopted: March 2000

Reaffirmed: March 2001

Contact: Richard J. Burk, Jr.
Executive Secretary

Health Physics Society
Telephone: 703-790-1745
Fax: 703-790-2672
Email: HPS@BurkInc.com
http://www. hps.org

EXECUTIVE SUMMARY

Based on the extensive knowledge of radiation health effects, the Health Physics Society believes that a
person's radiation dose must be considered in determining whether to provide compensation for a
disease that could have been caused by radiation. Further, there should be no compensation for persons
whose lifetime doses are less than approximately 0.1 Sv (10 rem).

INTRODUCTION

Many workers and members of the general public who have actually, or possibly, been exposed to
radiation since the widespread introduction of technologies using radiation or radioactivity are now at the
age where they will be more likely to experience a variety of diseases. We know that some diseases may
be caused by high doses of radiation. The most reliable studies of the effects of radiation exposure at the
low levels received by occupational workers and members of the public have not been able to detect
adverse health effects associated with their radiation exposure except at the higher doses, i.e., greater than
approximately 0.1 Sv. Even at the higher doses, the studies are not all consistent. However, inherent
limitations of these studies leave open the possibility there are small undetected risks at the low levels of
exposure experienced in the workplace and in the environment.

Social values and conscience have evolved with the changing of national priorities since the 1940s and
1950s, resulting in the examination of yesterday’s practices for radiation safety in light of today’s political
environment and knowledge. This has led to proposals for disease-compensation programs based on the
presumption of causation of disease by low levels of radiation exposure. Presumption of causation means
that a person with a disease could be compensated on the pure assumption that the disease was caused by
radiation without evidence of receiving any radiation exposure or for receiving radiation exposure at
levels not known to cause the disease.


appear to meet the provision in the Act that allows designation of an SEC if “it is
not feasible to estimate with sufficient accuracy the radiation dose that the
[individual members of] the class received.” However, it is a common health
physics practice to make worst-case scenario assumptions to estimate a
“pounding dose” in the absence of records. This practice is recognized and
incorporated into the 42CFR82 procedures in 42CFR82.10(k). | However,
someone that is reading 42CFR83 may not know 42CFR82 incorporates this
practice and may mistakenly assume the absence of records will automatically
qualify as a determination that NIOSH could not complete a dose reconstruction
for the individual.

The Health Physics Society recommends 42CFR83.5 or 42CFR83.9 include
clarification that a dose reconstruction is considered completed in
accordance with 42CFR82 if “worst-case” assumptions, which do not
underestimate the dose to the employee, demonstrate the employee could
not have incurred a compensable level of radiation dose.

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,

foe Be

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

Enclosures


of performing a dose estimate which include: (1) evaluation of people
doing the same work who were properly monitored or who already have
approved dose estimates; (2) length of exposure and dose rate or
radioactive material concentrations in the area; and, (3) the application
of evolving biological measurement techniques. These guidelines
should also address how to handle the areas of uncertainty in
performing dose reconstruction. Examples of these areas of known, or
potential uncertainty are:

a. Appropriateness of personnel monitoring techniques when
monitoring records are available with considerations of
monitoring device location on the body (external), sample
time versus exposure time (bioassay for internal), sensitivity
of monitoring techniques, appropriateness if in an accident
situation, etc.

b. Changes in radiation protection standards, terminology,
radiation monitoring practices, and radiation dosimetry
methodologies over time

c. Collation and resolution of multiple sources of exposure
data

DESIGNATION OF SPECIAL EXPOSURE COHORTS

A. Proposed Fundamental Principles for establishing a process to

consider and decide whether to designate additional classes of workers
to be included in the Special Exposure Cohort:

. The conditions for designation of a class of workers as a Special
Exposure Cohort must be extraordinary enough to justify disregarding
scientific fact.

. The only doses needed to be determined with “sufficient accuracy” are
those doses which are in the range of the minimum compensable dose
and the compensable probability of causation value for the designated
disease.

. Special Exposure Cohorts can be designated for specific diseases and
sub-populations of a given facility.

. The currently designated Special Exposure Cohorts in the EEOQICA do

not provide any precedence for establishment of guidelines for
designation of Special Exposure Cohorts in the future.

11


HEALTH PHYSICS SOCIETY

NK founoen 198877
\socrert/ Specialists in Radiation Safety

PAUL S. ROHWER, PhD, CHP
President

989 W. Outer Drive

Oak Ridge, TN 37830

Tel: (865) 483-1879
May 2, 2001 Fax: (865) 425-0234

Email: PaulSandyR@aol.com
Mr. L. J. Elliott (R-45)

Acting Director, Office of Compensation Analysis and Support
National Institute for Occupational Safety and Health

4676 Columbia Parkway

Cincinnati, Ohio 45226

Dear Mr. Elliott:

As President of the Health Physics Society (HPS), I am pleased to provide the
enclosed comments and input to the National Institute for Occupational Safety and
Health (NIOSH) on responsibilities delegated to NIOSH by the Energy
Employee’s Occupational IlIness Compensation Act (EEOICA) of 2000, and
Executive Order 13179. These comments and input are provided in response to
your invitation for such contained in your letter to our Congressional Liaison,
Keith H. Dinger, dated April 6, 2001.

Thank you very much for the opportunity to provide these comments and input.
NIOSH has been given a number of important tasks in the process of establishing
and implementing a program to provide fair compensation to deserving workers
within the Department of Energy nuclear weapons complex. The HPS is
appreciative of the opportunity to offer its expertise in the field of radiation
sciences to assist you with these tasks.

Your letter requested comments and input on three areas of responsibility. These
areas deal with the development of guidelines and promulgation of regulations on:
(1) probability of causation; (2) dose reconstruction; and, (3) designation of
Special Exposure Cohorts. The enclosed HPS comments and input are organized
into these three areas with additional comments and input addressing the general
process of developing and implementing a fair and equitable compensation
program.


Page 1 of 1

Miller, Diane M.

From: _ Keith Dinger [keith.dinger@verizon.net]
Sent: Monday, August 26, 2002 1:09 PM

To: NIOCINDOCKET@CDC.GOV
Subject: HPS Comments on 42CFR83

Dear Sir or Madam:

I am forwarding, on behalf of the Health Physics Society's President, Dr. John R. Frazier, comments on the Notice of
Proposed Rulemaking for Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort
Under the EEOICPA of 2000 as published in the Federal Register, Vol. 67, No. 122, Pages 42962 to 42973 of June 25,
2002.

The comments are contained in the attached letter, HPScomments.42CFR83.doc, with two enclosures,
HPScomments.42CFR83.enclosure] and HPScomments.42CFR83.enclosure2.

Please to do not hesitate to contact Dr. Frazier or myself if you have any questions about these comments. Please contact
me if you have any problems receiving the documents.

Sincerely,

Keith H. Dinger, CHP

HPS Governmental Liaison
Tel: 603-692-4270

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

9/9/2002


|. 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.

. 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.

3. 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.

5. 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

HEALTH PHYSICS SOCIETY

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 (EEPICA) of 2000
And
Executive Order 13179

Offices of the Executive Secretary, 1313 Dolley Madison Blvd., Suite 402, McLean, VA, 22101

Phone: (703) 790-1745 Fax: (703) 790-2672 Email: hps@burkinc.com Home Page: www.hps.org
3


oe

RADIATION AND DISEASE

Our knowledge about the potential health effects of ionizing radiation is extensive. It is known that
radiation cannot cause all types of disease. It is also known that for those diseases observed to be caused
by radiation, the likelihood that radiation will cause the disease increases as the dose increases. In other
words, any particular disease’s likelihood to have been caused by radiation is dependent on the dose to the
individual. 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.

Presumption of causation has no scientific or medical basis without consideration of dose. That is, the
simple fact that some radiation exposure occurred is not a measure of hazard. The amount of exposure
(i.e., the dose) is the only measure of the hazard and the only measure of the likelihood a disease or injury
has been caused by radiation. In addition, everyone is exposed to natural sources of ionizing radiation
every day without any observable effects. Therefore, exposures that are potentially hazardous, justifying
consideration of compensation, must significantly exceed exposures from normal life activities.

DOSE DETERMINATION

Given the scientific knowledge that the relationship between ionizing radiation exposure and disease
depends on the dose, the issue of disease causation often concentrates on the adequacy of knowing the
actual, or possible dose to the populations of interest.

Personnel dosimetry by use of film badges, and other detection devices, was well established by the early
1950s. When available, the results of personnel dosimetry devices provide an excellent basis for
establishing doses to individuals. When personnel dosimetry results are not available, reconstruction of a
dose, and in particular a range of doses, can reasonably be done. The dose to an individual from a
specified source is a matter of physical and physiological parameters based on the radiation source and
exposure mode. Given the identification of the radiation source and the exposure mode, dose
reconstruction can provide a calculation of the dose and dose range that is adequate to support decisions
on whether a selected population, or an individual having a disease or injury, may have been affected by
that particular radiation exposure.

COMPENSATION PROGRAMS

The Health Physics Society strongly supports compensation for individuals who are injured, or wronged,
by practices which have clearly caused them harm. However, the reason for allocating public funds to
provide compensation to selected individuals should be clearly stated. If the reason 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.

* The Health Physics Society is a non profit scientific professional organization whose mission is to promote the practice
of radiation safety. Since its formation in 1956, the Society has grown to approximately 6,000 scientists, physicians,
engineers, lawyers, and other professionals representing academia, industry, government, national laboratories, the
department of defense, and other organizations. Society activities include encouraging research in radiation science,
developing standards, and disseminating radiation safety information. Society members are involved in understanding,
evaluating, and controlling the potential risks from radiation relative to the benefits. Official position statements are
prepared and adopted in accordance with standard policies and procedures of the Society. The Society may be contacted
at: 1313 Dolley Madison Blvd,. Suite 402, McLean, VA 22101; phone: 703-790-1745; FAX: 703-790-2672; email:
HPS@Burkinc.com.


The Society requests the proposed rule clarify that, through the use of
standard dose reconstruction techniques such as worst-case scenarios, it
will only be in extraordinary circumstances that the procedures of 42CFR83
will be required to designate SECs.

The Department of Health and Human Services (HHS) invited comments on “its
proposed interpretation of health endangerment and approach to evaluate it.”

Dr. Rohwer's letter of May 2, 2001, proposed that a fundamental principle for
developing guidelines and regulations under the Act be that “Guidelines and
regulations [be] founded upon, and consistent with the most current consensus
scientific knowledge.” Additionally, he proposed that a fundamental principle for
designating additional classes of Special Exposure Cohorts be that “Special
Cohorts [be] designated for specific diseases.”

The proposed procedures for adding classes of employees to the Special
Exposure Cohort do not adopt either of these recommended fundamental
Principles.

Paragraph Ill. Subtitle C — Procedures for adding Classes of Employees to the
Cohort, describes the procedure to implement the requirement that there be “a
reasonable likelihood that such radiation dose may have endangered the health
of members of the class.”. The procedure involves using the software tool
NIOSH-IREP to determine the threshold dose for the “most radiogenic specified
cancer” for the exposure conditions to which the employees were potentially
exposed. Exposure conditions involving the intake of radioactive materials may
result in widely varying doses to individual organs. In addition, it is known that
the radio-sensitivity of individual organs varies widely. Footnote 3, page 42966,
states that “Despite selection of the most radiogenic cancer to calculate
probability of causation, once a class of employees has been added to the
Cohort, members would be eligible for compensation for incurring any of the
specified cancers, not only the cancer used for this calculation.” This
explanation is not included in the proposed rule itself, and 42CFR83.12(c)(2)
does not specifically include specified cancers as one of the parameters used to
define the SEC.

The proposal to include all specified cancers in an SEC if the cohort has a
Potential to receive a compensable exposure for any one cancer does not
use current scientific knowledge about the differing radio-sensitivities of
various organs or the possibility of widely varying organ doses under
certain exposure conditions.

It is possible under the proposed 42CFR83 that an SEC could be established
based on one of the more radio-sensitive organs, one of the rare cancers with a
large uncertainty, or one of the higher dosed organs from the exposure


populations exposed below this value. This value should be
approximately 0.1 Sv (10 rem).

B. Discussion:

1. With regard to proposed fundamental principle II.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

7


4. Dose reconstruction methods should be developed and performed by
an expert committee of qualified radiation health professionals with full
understanding of the areas of uncertainty.

B. Discussion:

1. With regard to proposed fundamental principle IIl.A.1 above, this
principle reinforces the provisions of the EEOICA (Sec. 3623 (c) (3) (A))
that guidelines for determination of causation be based on radiation
dose of the employee. The HPS position that dose reconstruction,
either based on personnel monitoring devices or on reconstruction
techniques, can provide a calculation of the dose and dose range that is
adequate to support compensation decisions is contained in the
attached position statement on compensation. In its report to the
Senate, the GAO (GAO/HEHS-00-32) concluded “Available scientific
studies indicate that dose reconstruction is a valid method for estimating
veterans’ exposure to decide disability claims, and we have not
identified a better alternative.” This conclusion is directly applicable to
the cohort of energy employees subject to the EEOICA.

2. With regard to proposed fundamental principle III.A.2 above, the
methodology adopted for calculating the probability of causation will
determine the methods for doing dose reconstruction.

For example, each facility covered by the EEOICA should have an
historical exposure assessment performed by radiation health
professionals that provides information about the potential for exposure
to personnel based on areas in the facility and/or work operations
performed in the facility as a function of time. This historical exposure
assessment should consider all the issues of uncertainty discussed in
Paragraph III.B.4 below. Such facility historical exposure assessments
have been performed on many facilities and are a standard task for
radiation health professionals. The results of the facility historical
exposure assessment are then used as a “screening” tool for an
individual claimant. “Screening” is an initial dose analysis intended to
focus resources on those cases that warrant a more detailed analysis.
Using the individual's work history information, a screening assessment
can be performed using the facility historical exposure assessment to
determine if it is reasonable that the individual claimant could have
received exposure in excess of the minimum compensable dose for
their specific disease. The screening calculation can be refined to be
more rigorous the closer the individual’s screening dose calculation is to
the minimum compensable dose. If the screening dose is significantly
below, or above the minimum compensable dose then the individual can
be screened out, or screened in without further dose reconstruction

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One of the proposed fundamental principles contained in Dr. Rohwer’s letter for
designating a SEC was that “The conditions for designation of a class of workers
as a Special Exposure Cohort must be extraordinary enough to justify
disregarding [the scientific fact that the likelihood a specific cancer is associated
with an individual's exposure is dependent on the individual's dose].” The
Proposed rule establishes a process for designating an SEC that is dependent
on the determination that a dose reconstruction cannot be completed by NIOSH
in accordance with 42CFR82. This process establishes that the “extraordinary”
condition justifying the designation of an SEC is a condition in which NIOSH
cannot complete a dose reconstruction for the purposes of determining
compensation for an individual.

The Health Physics Society cannot conceive of a situation in which a dose
reconstruction, including the establishment of an “upper bound” dose,
cannot be performed, thus permitting the determination of compensation
on an individual basis in accordance with 42CFR81 and 42CFR82.

Determination of an upper bound, or “worst-case scenario” dose is a standard
health physics practice. An upper bound dose can be calculated with minimal
information about the source of radiation exposure and potential exposure
Conditions of the individual. Although an upper bound dose has the potential for
being very different from the actual dose an individual received, it does represent
an upper limit to the possible dose and is more accurate than an assessment
that no “reconstruction of the dose is possible.”

The dose reconstruction rule, 42CFR82, recognizes there are potential situations
in which the dose cannot be reconstructed with “sufficient accuracy” to permit the
determination of a dose for use in determining compensation. The dose
reconstruction rule provides for the use of worst-case scenario doses only to
determine that an individual's claim does not warrant further research because
the worst-case dose excludes the possibility of a compensable level of exposure.
In responding to comments on 42CFR82, HHS explained that the conditions
under which NIOSH would not have sufficient information to complete a dose
reconstruction will vary on a case-by-case basis and that the definition could not
use rigid criteria because the potential circumstance are not readily foreseeable.

Although the Society agrees that not all potential circumstances can be readily
foreseeable, we believe that the possibility of not being able to reconstruct an
upper bound dose on an individual is small and that the use of an individual
upper bound dose for determination of compensation is based in science, unlike
the designation of SECs for which individual doses are not considered. The
Society believes that these concepts should be clearly explained in the proposed
tule because the conditions under which a finding of not being able to determine
dose have not been clearly stated in 42CFR82.


HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

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

August 26, 2002 Auxier & Associates, Inc.
Suite 1

CDC/NIOSH Docket Officer 9821 Cogdill Road

CDC/NIOSH Docket Office Knoxville, TN 37932

Robert A. Taft Laboratories, M/S C34 865-675-3669

jfrazier@auxier.com

4676 Columbia Parkway
Cincinnati, Ohio 45226

Subject: Comments on the Notice of Proposed Rulemaking on Procedures 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 67 FR 42962 through 42973, June 25, 2002

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 specialized expertise in issues related to the implementation of the Energy
Employees Occupational Illness Compensation Program Act (the Act). 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.

The Health Physics Society has issued a position statement titled
“Compensation for Diseases That Might Be Caused by Radiation Must
Consider the Dose.” The Society position statement has been provided to the
National Institute of Occupational Safety and Health (NIOSH) in previous
communications and is enclosed with this response for further reference.
Additionally, on May 2, 2001, Society President Paul S. Rohwer provided Mr. L.
J. Elliott, Acting Director of the NIOSH Office of Compensation Analysis and
Support, the enclosed comments and recommendations regarding the
development of guidelines and regulations covering the major issues involved in
implementing the Act, including the issue of designating employees as
members of the SEC. The following additional comments are based on the
Society's position statement and Dr. Rohwer’s letter of May 2, 2001.


B. Discussion:

1.

With regard to proposed fundamental principle |.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

5


A.

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 can not be observed, but where it can only be estimated
using hypothetical mathematical dose-response models. This
extrapolation is an example of a quantitative estimation of health
tisks below 10 rem with which the HPS does not agree.

3. In summary, incorporation of fundamental principles 1.A.1, II.A.1, and
II.A.2 results 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 |.A.2.

DOSE RECONSTRUCTION
Proposed Fundamental Principles for developing guidelines and

promulgating regulations to be used to estimate the cumulative past
radiation doses incurred by individual claimants:

. Dose reconstruction is a standard and valid practice for estimating the

amount of radiation exposure when more direct evidence is not
available.

. Dose reconstruction need only support the information required to

evaluate the probability of causation and not necessarily attempt to
estimate a highly refined dose if such refinement does not make a
difference in the probability of causation calculation.

. Dose reconstruction should estimate a “maximum realistic” dose for use

in the probability of causation calculation.
8