[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Notices]
[Pages 14896-14897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4314]


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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 NIOSH-IREP Lung Cancer Risk Model Under the Energy Employees 
Occupational Illness Compensation Program Act of 2000

    Authority: 42 CFR 81.12, 67 FR 22311-22312.

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice for public comment; change to a scientific element 
underlying the determination of probability of causation 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 a guideline for determining the probability of 
causation under the Energy Employees Occupational Illness Compensation 
Program Act of 2000 (EEOICPA) for energy employees with cancers of the 
lung, trachea, or bronchus. The change affects only the NIOSH-
Interactive RadioEpidemiological Program (IREP) cancer risk model 
termed ``Lung (162).'' The new guideline, which became effective on 
February 28, 2006, with the introduction of NIOSH-IREP Version 5.5, 
requires the use of both a National Institutes of Health (NIH)-IREP 
lung model implemented by NIH in 2003 and the original NIOSH-IREP lung 
model implemented by NIOSH in 2002. NIOSH-IREP Version 5.5 calculates 
separately the probability of causation produced under each model for 
each cancer of the lung, trachea, or bronchus. The result from the 
model that produces the higher probability of causation at the upper 
99th percentile credibility limit is reported as the probability of 
causation result of record for the claim. NIOSH-IREP Version 5.5 also 
incorporates a bias correction factor for random errors in dosimetry 
for those energy workers who had not smoked cigarettes (``never 
smokers'') and who were exposed to radon. This correction was 
previously applied to smokers, but had been inadvertently omitted for 
never smokers. These changes may result in the Department of Labor 
(DOL) calculating higher probability of causation determinations for 
select cases of cancer of the lung, trachea, or bronchus among 
previously decided and current EEOICPA cancer claims. The changes 
cannot result in any lower probability of causation determinations. 
Although this change to the NIOSH-IREP lung cancer risk model took 
effect February 28, 2006, NIOSH will fully consider all comments 
received regarding this change and may reconsider this change or 
consider further revisions to the lung cancer risk model based on 
public comment.

DATES: NIOSH must receive public comments on this change on or before 
May 23, 2006.

ADDRESSES: Comments may be submitted by mail or e-mail. Mail comments 
concerning this 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, OH 
45226. Submit electronic comments, titled ``NIOSH-IREP Lung Cancer 
Model'', 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:

I. Solicitation of Public Comments

    NIOSH invites public comments on this change to the NIOSH-IREP lung 
cancer risk model. NIOSH will fully consider comments received 
regarding this change and, based on such comments, may reconsider this 
change or consider further revisions to the lung cancer risk model, as 
appropriate. Additional details regarding this change to NIOSH-IREP, 
including PDF copies of all relevant documents provided to the Advisory 
Board on Radiation and Worker Health, can be accessed via the NIOSH/
OCAS ``Probability of Causation--NIOSH-IREP'' Web page at http://www.cdc.gov/niosh/ocas/ocasirep.html.

II. Summary of Changes to the Guidelines for Determining Probability of 
Causation for Cancers of the Lung, Trachea, or Bronchus as Effected in 
the February 28, 2006, Implementation of NIOSH-IREP Version 5.5

    Under HHS regulations at 42 CFR part 81, NIOSH developed and 
maintains NIOSH-IREP. This computerized set of cancer risk models is 
used by DOL to calculate the statistical probability that the cancer or 
cancers of an energy employee covered under EEOICPA were at least as 
likely as not caused by exposure to ionizing radiation incurred by the 
employee while in the performance of duty for U.S. nuclear weapons 
programs.
    HHS regulations also provide for NIOSH to add, modify, or replace 
cancer risk models as necessary on the basis of new evidence and/or 
improved scientific understanding. Accordingly, on February 28, 2006, 
NIOSH modified its cancer risk model ``Lung (162)'' to incorporate new 
evidence concerning the radiogenicity of lung cancer and its 
relationship with cigarette smoking and to make a minor technical 
correction concerning radon exposure.
    NIOSH evaluated new interpretations of the interaction between 
cigarette smoking and ionizing radiation and the effects of age at 
exposure and age at diagnosis with respect to the development of 
cancers of the lung, trachea, or bronchus. In conjunction with this 
evaluation, NIOSH also reviewed a new lung cancer risk model 
implemented in 2003 by the National Cancer Institute for use in a 
separate version of IREP known as ``NIH-IREP'' and compared it to the 
model in NIOSH-IREP.
    The NIH lung cancer risk model relies less on a multiplicative 
interaction than does the NIOSH model to account for the interaction 
between cigarette smoking and ionizing radiation in the development of 
lung cancer. The NIH model also adjusts risk for age at exposure and 
age at diagnosis, whereas the NIOSH model does not take into account 
these age-dependent factors. In terms of probability of causation, the 
NIH model is generally more favorable to smokers for some exposure 
profiles than the NIOSH model, whereas the NIOSH model is generally 
more favorable to nonsmokers for some exposure profiles. Other 
probability of causation calculation differences

[[Page 14897]]

between the models vary with the circumstances of each individual claim 
and are more difficult to generalize. In summary, however, the same 
inputs entered into NIH-IREP and the previous version of NIOSH-IREP for 
a cancer of the lung, trachea, or bronchus could produce different 
probabilities of causation for some exposure profiles.
    The NIOSH review also included consideration of recommendations 
submitted by four internationally-recognized outside experts. The 
experts recruited by NIOSH were: David J. Brenner, PhD, Professor of 
Radiation Oncology and Public Health, Columbia University School of 
Public Health; Faith G. Davis, PhD, Professor of Epidemiology and 
Biostatistics, University of Illinois at Chicago, School of Public 
Health; David B. Richardson, PhD, Assistant Professor of Epidemiology, 
University of North Carolina School of Public Health; and Jonathan M. 
Samet, MD, MS, Professor and Chairman, Department of Epidemiology, 
Johns Hopkins University School of Public Health. Each expert reviewed 
the issue independently, considering the appropriateness of the NIOSH 
and NIH models and any alternatives to the use of these models. The 
only general consensus among all four reviewers was that none 
recommended the exclusive retention of the NIOSH lung model. Beyond 
this, there was a diversity of opinion as to how to properly 
characterize and model the interaction between cigarette smoking and 
ionizing radiation.
    In accordance with the experts' opinions, NIOSH concluded that the 
current state of scientific knowledge does not support the exclusive 
use of either of the two IREP lung cancer risk models, and that the 
most reasonable option within the context of compensation was to 
reprogram NIOSH-IREP to run both the NIOSH and the NIH lung cancer risk 
models separately for each relevant EEOICPA case, and then to select 
the model that produces the higher probability of causation result for 
application to the case. The programming was accomplished and 
implemented on February 28, 2006, with the installation of NIOSH-IREP 
Version 5.5, which replaced NIOSH-IREP Version 5.4.
    NIOSH-IREP Version 5.5 also incorporates a bias correction factor 
in the NIOSH lung model for random errors in dosimetry for ``never 
smokers'' who were exposed to radon. Due to a programming oversight, 
this correction had been inadvertently omitted for never smokers and 
was applied only to smokers in earlier versions of NIOSH-IREP. NIOSH-
IREP Version 5.5 corrects this error.
    The changes introduced in NIOSH-IREP Version 5.5 on February 28, 
2006, pertain only to the NIOSH-IREP cancer risk model termed ``Lung 
(162)'' and apply only to cancers of the lung, trachea, or bronchus. 
NIOSH will review all relevant previously completed claims that have 
not been compensated to identify those for which the new guidelines are 
applicable, and will re-evaluate the claims using the new guidelines. 
NIOSH will also apply the new guidelines to all currently active claims 
and any future cases. Application of these new guidelines may result in 
DOL calculating higher probability of causation determinations for 
select lung, trachea, or bronchus cases among previously decided and 
current EEOICPA cancer claims. As noted above, the changes cannot 
result in any lower probability of causation determinations.

III. Summary of Recommendations of the Advisory Board on Radiation and 
Worker Health

    Under 42 CFR 81.12, NIOSH is required to obtain the review of the 
Board before making changes to NIOSH-IREP that would have a substantial 
effect on probability of causation calculations. NIOSH notified the 
Advisory Board on Radiation and Worker Health (ABRWH) of its intent to 
re-evaluate the NIOSH-IREP lung cancer risk model and to review the 
NIH-IREP lung cancer risk model as a possible alternative model during 
a meeting of the Board on December 15, 2004. After the NIOSH review and 
evaluation was completed, NIOSH presented information describing and 
proposing the current NIOSH-IREP change to the Board, including a 
summary of the NIOSH evaluation and the expert reviews discussed above. 
The Board considered the change and voted unanimously to support it 
during the October 19, 2005, meeting of the Board in Knoxville, 
Tennessee. The motion to support the change included a provision that 
NIOSH should revisit the issue in approximately one year to determine 
if new evidence might warrant consideration of a single lung cancer 
risk model.
    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: March 17, 2006.
John Howard,
Director, National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).
[FR Doc. E6-4314 Filed 3-23-06; 8:45 am]
BILLING CODE 4163-18-P