[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7969-7970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Institute for Occupational Safety and Health; 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: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of a Change to a Scientific Element Underlying Radiation 
Dose Reconstructions under the Energy Employees Occupational Illness 
Compensation Program Act of 2000.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) has changed 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 change responds 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 includes 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 may result in the Department of Labor calculating 
higher probability of causation determinations for select lymphoma 
cases among previously decided and current EEOICPA cancer claims.

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:

I. Summary of Public Comments

    NIOSH accepted public comments on this proposed change to NIOSH 
dose reconstruction methods from January 19, 2006, through February 3, 
2006. NIOSH received 15 comments from individuals.
    Nine comments expressed support for the new lymphoma procedure, 
predicated on the condition that it improves chances of compensation 
being granted.
    One comment objected to the different treatment of ``structural'' 
lymphomas (i.e., Hodgkin's disease, lymphosarcoma, reticulosarcoma, 
etc.) versus non-Hodgkin's and other lymphomas. A NIOSH scientist 
contacted the commenter and explained the technical basis for these 
distinctions, which in summary is that tumor location is informative of 
the site of radiation injury for such structural lymphomas. Upon this 
explanation, the commenter concurred with the procedure as proposed by 
NIOSH.
    Five comments concerned individual claims for compensation rather 
than the new lymphoma procedure.

II. Summary of Recommendations of the ABRWH

    The Advisory Board on Radiation and Worker Health (ABRWH) discussed 
the change and voted unanimously to support it during a teleconference 
meeting of the Board on January 9, 2006.

III. Summary of the Changes to the Dose Reconstruction Target Organ 
Selection for Lymphoma

    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. 42 CFR 82.30-82.33. Accordingly, NIOSH 
has updated its method for reconstructing radiation doses in cases 
involving certain lymphoma cancers. Specifically, NIOSH has changed 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 
presented the proposed change to the ABRWH prior to implementation. 
NIOSH has also considered all public comments concerning this change 
that were 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 were two problems with NIOSH's 
previous 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 
contributed to the possibility that under the previous method for 
select lymphoma cases, NIOSH could not be certain its dose 
reconstruction was based on the biologically plausible organ with the 
highest radiation dose.
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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 (1. Evaluation of Target Organ for Lymphomas; note, 
this information can be found under the ``Miscellaneous Items'' 
section on this page).
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    As a result of this re-evaluation, NIOSH has modified 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 original radiation injury (e.g. Hodgkin's disease, lymphosarcoma, 
etc.), the information related to the site of diagnosis will be 
considered in target organ selection.
    This 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

[[Page 7970]]

of causation, nor does it impact the cancer risk models themselves.
    This change in NIOSH dose reconstruction methods is likely to have 
a substantial effect on certain EEOICPA cancer cases involving 
lymphomas. NIOSH will review all relevant previously completed dose 
reconstructions for cases that have not been compensated to identify 
those for which this new method is applicable, and will re-complete 
these dose reconstructions using this new method. NIOSH will also apply 
this new method in dose reconstructions for all currently active 
lymphoma claims and any future cases. Application of this new method 
may result in the Department of Labor calculating higher probability of 
causation determinations for select lymphoma cases among previously 
decided and current EEOICPA cancer claims.
    The Director, National Institute for Occupational Safety and Health 
(NIOSH), has been delegated the authority to sign Federal Register 
notices for CDC that pertain to NIOSH programmatic matters.

    Dated: February 8, 2006.
John Howard,
Director, National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).
 [FR Doc. E6-2116 Filed 2-14-06; 8:45 am]
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