addressing this issue elsewhere, the definition of claimant should be broadened to include a
person or persons acting on behalf of the claimant.

4) Additional comments not directly related to the three generic topics.

Film badge records and other records of external dose measurements will be used to
assess external doses, when available, including exposures from medical screening x-rays that
were required as a condition of employment. HHS may wish to evaluate the propriety of
including medical radiation exposure (or an estimate of medical radiation exposure) as a result
of work related injuries. In addition, medical x-ray procedures are sometimes repeated
because of a variety of factors. There should be some means to accommodate the radiation
dose from unsuccessful x-ray procedures associated with employment at a covered facility.

The rule should clearly state that the dose reconstruction process will only consider
occupational radiation doses received at a “covered facility” and not consider occupational
doses received at non-covered facilities or medical and dental x-ray exposures not related to
employment at covered facilities.

The Health Physics Society understands and appreciates the societal impetus of the
Energy Employees Occupational Illness Compensation Act of 2000. We trust that the
information provided in this letter is of use in this important effort.

Thank you for the opportunity to comment on the interim rule.
Sincerely,

Menge Ane

George Anastas, President
Enclosure



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:

4. With regard to proposed fundamental principle III.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 II|.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 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



|. 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.

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

NK Founnen 195547

SELECTED PORTIONS RELATED TO DOSE RECONSTRUCTION FROM
THE

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

WHICH WAS ENCLOSED IN A LETTER FROM PAUL ROHWER TO
L. J. ELLIOTT DATED MAY 2, 2001

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. 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.

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.



Miller, Diane M.

From: Kris Berkebile [KBerkebile@BurkInc.com]

Sent: Monday, November 05, 2001 2:50 PM

To: NIOCINDOCKET@CDC.GOV

Ce: rburk@Burkinc.com; kdinger@ttlc.net; anastas@eeg.org
Subject: HPS Comments on 42CFR82

)
HPSComments.42C
FR82.doc

Dear Sir or Madam:

1 am forwarding the attached document on behalf of the President of the

Health Physics Society, George Anastas. The document contains comments on
the Iterim Final Rule on Methods for Radiation Dose Reconstruction Under

the Energy Employees Occupational Iliness Compensation Program Act as
presented in 66 FR 50978 through 50991, October 5, 2001.

Regards,
Kris Berkebile

Kris Berkebile

Secretariat

1313 Dolley Madison Blvd.
Suite 402

McLean VA 22101
703-790-1745

FAX: 703-790-2672


4. 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



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
judgment, 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 I.A.7.

3. 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
judgment, 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.



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.

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 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.


refers to “Annual dose estimates”, without specifying dose to what, and § 82.26(b)(2) follows
with a description of doses to “the primary cancer site(s).” There should be no reason to
reconstruct doses other than those associated with the organ(s) or tissue(s) relevant to the
specific claim. This should be clearly stated in the rule and the ambiguity of § 82.26(b)(1)
and (2) should be clarified. :

Society recommendation II.A.3 in the enclosure is that “Dose reconstruction should
estimate a “maximum realistic” dose for use in the probability of causation calculation.” It is
not clear if the “maximum realistic” dose is the same as the “highest reasonably possible
value” contained in the definition of worst-case assumption in the rule [§ 82.5(r)].

The definition of worst-case assumption includes the provision that it assigns the
highest reasonably possible value, based upon reliable science, documented experience and
relevant data, to a radiation dose to a covered employee. In §82.2(a) the example of a
worst-case assumption relates to the solubility classification of an inhaled material. If the
classification cannot be determined, the dose reconstruction would use the classification that
results in the largest dose to the organ or tissue relevant to the cancer. To be consistent with
the definition of worst-case assumption, this example should include the condition that the
classification chosen will be reasonable for the exposure or work place conditions. It would
be helpful if other examples of worst-case assumptions are identified and evaluated against
reasonable criteria. The use of worst-case assumptions should be judicious and have a strong
scientific and practical basis.

2) Does the interim rule appropriately balance the potential precision of dose
reconstructions and the necessary efficiency of the dose reconstruction process?

We understand that NIOSH is establishing a dose reconstruction process that limits the
work effort where it is evident the outcome of the compensation claim will be unaffected
because the use of worst-case assumptions does not produce a compensable level of radiation
dose. We think this approach is reasonable and should result in reducing unnecessary efforts
while maintaining the integrity of the process.

3) Does the interim rule implement an appropriate process for involving the
claimant in the dose reconstruction?

It is unclear if the interim rule allows for the estate of a claimant to act on behalf of the
claimant. We think a clarification of the potential role of the claimant’s estate would be of
value.

If the claimant were ill or infirm, the ability of a claimant to identify a person to act on
the claimant’s behalf would be an important provision. Accordingly, if there is not a provision


This interim rule is to provide methods for determining a reasonable estimate of
radiation dose to a covered employee diagnosed with cancer through a dose reconstruction.
The October 5, 2001, Federal Register Notice identified three generic topics for comment.
Society comments are provided within the context of these three 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 for conducting
dose reconstructions to be used in an occupational illness compensation program?

The interim rule provides the overall approach and structure for dose reconstruction in
support of the Act. There is considerable detail in implementing provisions of the rule that is
not contained in the rule itself. These implementation details, although not appropriate for
inclusion in this rule, are important for evaluating the appropriateness of the use of science in
conducting dose reconstructions. Therefore, the following comments are provided with the
reservation that these details are not available for review and evaluation.

With regard to this general concern for the implications of the implementation details,
this concern could be addressed by adopting Society recommendation I.A.3 in the enclosure.
Peer review by expert organizations, such as the National Academies, would include review
of the implementation details and their implication on the appropriate use of current science.
As noted in the discussion for this recommendation in paragraph I.B.3 of the enclosure, the
U.S. General Accounting Office concluded that “an independent review process . . . could
mitigate concerns about the integrity of the [dose reconstruction program for atomic
veterans].” This conclusion is also valid for the dose reconstruction program under the Act.
NIOSH should institutionalize a requirement for a periodic peer review in the rule.

We note that the methodologies of the most recent recommendations of the
International Commission on Radiological Protection (ICRP) will be used to estimate internal
radiation doses. We recognize the current ICRP recommendations (ICRP 60 and supporting
reports) are implemented essentially worldwide, with the exception of in the United States.
The fact the United States has not adopted these recommendations should be accommodated
in the rule. One accommodation would be by instituting the peer review by U. S. expert
groups as recommended above. Another accommodation would be to be very clear the ICRP
recommendations being used are only those associated with the metabolic models and
radiation weighting factors for calculating equivalent organ dose to the relevant organ(s) for
the specific cancer of concern. This would make it clear the organ weighting factors for
calculating an effective equivalent dose will not be used, and thus any criticism or concern for
the incorporation of non-fatal cancers, years of life loss, infinite hereditary risk, etc., into the
determination of these organ weighting factors will be obviated.

Although the rule refers to calculating the estimated annual equivalent doses to “the
relevant organ(s) or tissue(s)” [§ 82.10((j)] the report contents described in § 82.26(b)(1) only


HEALTH PHYSICS SOCIETY

Specialists in Radiation Safety

FOUNDED 1956

GEORGE ANASTAS, CHP
President

November 5, 2001 7007 Wyoming Blvd, NE: Suite F-2
Albuquerque, NM 87109

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

CDC/NIOSH Docket Office Fax: (505) 826.1062

Robert A. Taft Laboratories, M/S C34 mail: anastas@eeg.org

4676 Columbia Parkway

Cincinnati, Ohio 45226
VIA e-mail: NIOCINDOCKET@CDC.GOV

Subject: Comments on the Interim Final Rule on Methods for Radiation Dose Reconstruction Under
the Energy Employees Occupational Illness Compensation Program Act as presented in 66 FR 50978
through 50991, 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 has an interest in the implementation of the Energy Employees Occupational Illness
Compensation Program Act (the Act) and the methods for dose reconstruction 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, Society President Paul 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 dose
reconstruction 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.