[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]
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