COMPENSATION FOR DISEASES THAT
MIGHT BE CAUSED BY RADIATION
MUST CONSIDER THE DOSE

Y

FOUNDED 1958

\eoorert
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.


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.

2. 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 EEOQICA


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 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 individuats, 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 I.A.3 and the appeals
process recommended in proposed fundamental principle 1.4.7.

. 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


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).

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 II.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.


(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.

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 |.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.

ll. 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. 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.

3. Dose reconstruction should estimate a “maximum realistic” dose for use in
the probability of causation calculation.

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 Ill.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


Nay lA ony

HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

PAUL S. ROHWER, PhD, CHP
President
989 W. Outer Drive

Wonrert
Oak Ridge, TN 37830

May 2,200 Te a 19
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 Ilness 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.


IV.

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:

1.

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

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.

. 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

10


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


A.

The EEOICA (Sec. 3628 (c) (3) (A)) refers to the use of the
tadio-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 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 risks below 10 rem with which the HPS
does not agree.

3. In summary, incorporation of fundamental principles 1.A.1, II.A.1, and IIA.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
1A.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:

1. Dose reconstruction is a standard and valid practice for estimating the
amount of radiation exposure when more direct evidence is not available.


|. GENERAL PROCESS

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

1.

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.

. Guidelines and regulations should be subject to an established independent

peer review process using expert organizations such as the National
Academies.

. 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.

. 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.

. Guidelines and regulations should include provisions for an appropriate

appeals process by claimants.


RADIATION AND DISEASE N

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
(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.


Radiogenic Health Effects Have Not Been Observed Below 10 Rem

Radiogenic health effects (primarily cancer) are observed in humans only at doses in excess of 10
rem delivered at high dose rates. Below this dose, estimation of adverse health effect is
speculative. Risk estimates that are used to predict health effects in exposed individuals or
populations are based on epidemiological studies of well-defined populations (e.g., the Japanese
survivors of the atomic bombings in 1945 and medical patients) exposed to relatively high doses
delivered at high dose rate. Epidemiological studies have not demonstrated adverse health effects
in individuals exposed to small doses (less than 10 rem) delivered in a period of many years.

Limit Quantitative Risk Assessment to Doses at or Above 5 Rem per Year or 10 Rem
Lifetime

In view of the above, the Society has concluded that estimates of risk should be limited to
individuals receiving a dose of 5 rem in one year or a lifetime dose of 10 rem in addition to
natural background. Below these doses, risk estimates should not be used; expressions of risk
should only be qualitative emphasizing the inability to detect any increased health detriment (i.,
zero health effects is the most likely outcome).

Impact On Radiation Protection

Limiting the use of quantitative risk assessment, as described above, has the following
implications for radiation protection:

(a) The possibility that health effects might occur at small doses should not be entirely
discounted. Consequently, risk assessment at low doses should focus on establishing a range of
health outcomes in the dose range of interest including the possibility of zero health effects.

(b) Collective dose (the sum of individual doses in an exposed population expressed as
person-rem) remains a useful index for quantifying dose in large populations and in comparing
the magnitude of exposures from different radiation sources. However, for a population in which
all individuals receive lifetime doses of less than 10 rem above background, collective dose is a
highly speculative and uncertain measure of risk and should not be quantified for the purposes of
estimating population health risks.

* 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.



HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

ae

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 (EEOICA) 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


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,

Gad AK spur’

Paul S. Rohwer, Ph.D., CHP

Enclosures


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.

. 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.

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

. 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.

11


RADIATION RISK IN PERSPECTIVE

Founneo 1858 47

Y
Wont
POSITION STATEMENT OF THE
HEALTH HEALTH PHYSICS SOCIETY*

PHYSICS
SOCI ETY Adopted: January 1996

Reaffirmed: March 2001

Contact: Richard J. Burk, Jr.
Executive Secretary
Health Physics Society
Telephone: 703-790-1745
Fax: 703-790-2672

hitp://www.hps.org

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. Risk estimation in this
dose range should be strictly qualitative accentuating a range of hypothetical health outcomes
with an emphasis on the likely possibility of zero adverse health effects. The current philosophy of
radiation protection is based on the assumption that any radiation dose, no matter how small,
may result in human health effects, such as cancer and hereditary genetic damage. There is
substantial and convincing scientific evidence for health risks at high dose. Below 10 rem
(which includes occupational and environmental exposures), risks of health effects are either too
small to be observed or are non-existent.

Current radiation protection standards and practices are based on the premise that any radiation
dose, no matter how small, can result in detrimental health effects, such as cancer and genetic
damage. . Further, it is assumed that these effects are produced in direct proportion to the dose
received, i.e., doubling the radiation dose results in a doubling of the effect. These two
assumptions lead to a dose-response relationship, often referred to as the linear, no-threshold
model, for estimating health effects at radiation dose levels of interest. There is, however,
substantial scientific evidence that this model is an oversimplification of the dose-response
relationship and results in an overestimation of health risks in the low dose range. Biological
mechanisms including cellular repair of radiation injury, which are not accounted for by the
linear, no-threshold model, reduce the likelihood of cancers and genetic effects.

‘The rem is the unit of effective dose. In international units, 1 rem=0.01 sievert (Sv)