E6-542. 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.

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 [e-mail].

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: [phone] (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.

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.

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.

Footnotes

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.”)