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, 14896-14897 [E6-4314]
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Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices
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FOR FURTHER INFORMATION CONTACT:
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Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 06–2843 Filed 3–23–06; 8:45 am]
BILLING CODE 4150–31–P
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.
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.
wwhite on PROD1PC61 with NOTICES
AGENCY:
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
VerDate Aug<31>2005
18:26 Mar 23, 2006
Jkt 208001
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 OCAS@CDC.GOV.
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
the Advisory Board on Radiation and
Worker Health, can be accessed via the
NIOSH/OCAS ‘‘Probability of
Causation—NIOSH–IREP’’ Web page at
https://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
E:\FR\FM\24MRN1.SGM
24MRN1
wwhite on PROD1PC61 with NOTICES
Federal Register / Vol. 71, No. 57 / Friday, March 24, 2006 / Notices
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 internationallyrecognized 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–
VerDate Aug<31>2005
18:26 Mar 23, 2006
Jkt 208001
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.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
14897
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control; Special
Emphasis Panel: Centers for
Agricultural Disease and Injury
Research, Education and Prevention,
Program Announcement Number 06–
057
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Centers for Agricultural Disease
and Injury Research, Education and
Prevention, Program Announcement Number
06–057.
Times and Dates: 8 a.m.–5 p.m., May 1,
2006 (Closed).
8 a.m.–5 p.m., May 2, 2006 (Closed).
8 a.m.–5 p.m., May 3, 2006 (Closed).
8 a.m.–5 p.m., May 4, 2006 (Closed).
8 a.m.–5 p.m., May 5, 2006 (Closed).
Place: Residence Inn, 1456 Duke Street,
Alexandria, VA 22314 telephone 703–548–
5474.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to Centers for Agricultural Disease
and Injury Research, Education and
Prevention, Program Announcement Number
06–057.
For Further Information Contact: Steve
Olenchock, Ph.D., Scientific Review
Administrator, National Institute for
Occupational Safety and Health, CDC, 1095
Willowdale Road, MS 1119, Morgantown,
WV 26505, Telephone 304–285–6271.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
E:\FR\FM\24MRN1.SGM
24MRN1
]]>Agencies
[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Notices]
[Pages 14896-14897]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4314]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 OCAS@CDC.GOV.
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 https://
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
