[Federal Register Volume 71, Number 12 (Thursday, January 19, 2006)]
[Notices]
[Pages 3095-3096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health; Proposed
Changes to the Dose Reconstruction Target Organ Selection for Lymphoma
Under the Energy Employees Occupational Illness Compensation Program
Act of 2000
Authority: 42 CFR 82.32, 67 FR 22335-22336.
AGENCY: Department of Health and Human Services (HHS), Centers for
Disease Control and Prevention (CDC).
ACTION: Notice for public comment.
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SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) proposes to change the selection of target organs used in dose
reconstructions NIOSH produces under the Energy Employees Occupational
Illness Compensation Program Act of 2000 (EEOICPA) for energy employees
with lymphoma cancers. This proposed change is in response to an
evaluation by NIOSH of current scientific data on lymphoma, which
revealed that the site of the radiation injury can differ from the site
of the tumor or cancer origin documented in the medical files of a
lymphoma cancer patient. The new process for selecting dose
reconstruction target organs for energy employees with lymphoma cancers
would include selecting the target organ that would have received the
highest radiation dose from among relevant, possibly irradiated organs,
as determined through the dose reconstruction process, when the
identity of the target organ is in question. This change would result
in the Department of Labor calculating higher probability of causation
determinations for select lymphoma cases among previously decided and
current EEOICPA cancer claims.
DATES: NIOSH must receive public comments on this proposed change on or
before 15 days after the date of publication in the Federal Register.
ADDRESSES: Mail comments concerning this proposed change to Larry
Elliott, Director, Office of Compensation Analysis and Support,
National Institute for Occupational Safety and Health, 4676 Columbia
Parkway, Mailstop C-46, Cincinnati, Ohio 45226. Submit electronic
comments to [email protected].
FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of
Compensation Analysis and Support, National Institute for Occupational
Safety and Health, 4676 Columbia Parkway, Mailstop C-46, Cincinnati, OH
45226, Telephone: (513) 533-6800 (This is not a toll-free number).
SUPPLEMENTARY INFORMATION: NIOSH conducts radiation dose
reconstructions under EEOICPA in compliance with the dose
reconstruction methods specified in HHS regulations at 42 CFR part 82.
These regulations provide for NIOSH to update its dose reconstruction
methods as necessary on the basis of improved scientific understanding
and specify a process for deciding and implementing such updates (41
CFR 82.30-82.33). Accordingly, NIOSH is currently proposing to update
its method for reconstructing radiation doses in cases involving
certain lymphoma cancers. Specifically, NIOSH is proposing to change
its method for identifying the target organ for which radiation doses
will be reconstructed in these cases, for the reasons described below.
As required for certain updates in dose reconstruction methods, NIOSH
will present the proposed change to the Advisory Board on Radiation and
Worker Health for its comments. NIOSH will also consider all public
comments concerning this change that are received prior to the comment
deadline, as specified above.
NIOSH has re-examined the appropriateness of the current method of
selecting dosimetry target organs for lymphoma cases in light of the
current scientific knowledge on the diagnosis and etiology of the
various forms of lymphoma.\1\ This re-examination has revealed that for
many non-Hodgkin's lymphomas, there are two problems with NIOSH's
current target organ selection method. First, the site of occurrence of
the tumor is not necessarily the site of the original radiation injury.
Second, the site listed in the diagnosis may not actually be the site
of primary involvement. Rather, it is common to list the site of the
biopsy, which may be selected on the basis of medical considerations in
terms of the clinical symptoms and condition of the patient and the
ease of surgical access. Both of these problems contribute to the
possibility that under current methods for select lymphoma cases, NIOSH
is not certain to be basing its dose reconstruction on the organ that
has the highest radiation dose and may have been the site of origin of
the lymphoma of the energy employee.
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\1\ Crowther, M. Consultant's Report, Dose Reconstruction
Project. Prepared for the National Institute for Occupational Safety
and Health Office of Compensation Analysis and Support. 2005;
Eckerman, K.F. Target Organs for Lymphatic and Hematopoietic Cancers
Comments/Suggestions. Prepared for the National Institute for
Occupational Safety and Health Office of Compensation Analysis and
Support. 2005. Available online at: http://www.cdc.gov/niosh/ocas/ocasdose.html. (This information can be found on the aforementioned
Web page under the ``Miscellaneous Items'' heading in the section
``Evaluation of Target Organ for Lymphomas.'')
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As a result of this re-evaluation, NIOSH proposes to modify the
selection of target organs in select lymphoma cases so that the organ
that would have received the highest radiation dose from among
relevant, possibly irradiated organs, as determined through the dose
reconstruction process, is used in the dose reconstruction. For the
subset of lymphomas where tumor location is informative about the
probable site of the original radiation injury (e.g. Hodgkin's disease,
lymphosarcoma, etc.), information related to the site of diagnosis
would be considered in target organ selection.
This proposed change pertains only to the selection of the
appropriate target organ as the site of radiation injury (i.e., for
calculation of effective radiation dose during the dose reconstruction
process). It has no bearing on the selection of the appropriate
Interactive Radiological Epidemiology Program (IREP) cancer risk model
for determining probability of causation, nor does it impact the cancer
risk models themselves.
This proposed change in NIOSH dose reconstruction methods would be
likely to have a substantial effect on certain EEOICPA cancer cases
involving lymphomas. NIOSH would review all relevant completed dose
reconstructions for cases that have not been compensated to identify
those for which this new method is applicable, and would re-complete
these dose reconstructions using this new method, and would apply this
new method to all current and future cases undergoing dose
reconstruction. Application of this new method would result in the
Department of Labor calculating higher probability of causation
determinations for select lymphoma cases among previously decided and
current EEOICPA cancer claims.
[[Page 3096]]
The proposed change may be discussed at meetings of the Advisory
Board on Radiation and Worker Health on January 9, 2006
(teleconference) and January 24-26, 2006 in Oak Ridge, TN. Only after
the close of the public comment period will NIOSH make a final decision
regarding the proposed change.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities for
both the Centers for Disease Control and Prevention and the Agency for
Toxic Substances and Disease Registry.
Dated: January 10, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E6-542 Filed 1-18-06; 8:45 am]
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