Notice of Expert Peer-Review Meeting on the Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility From Early-Life Exposure to Carcinogens External Review Draft, 10766-10767 [E8-3788]
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rwilkins on PROD1PC63 with NOTICES
10766
Federal Register / Vol. 73, No. 40 / Thursday, February 28, 2008 / Notices
and older living in metropolitan areas
that experience episodes of high ozone
pollution levels in the summer.
Title: National-Scale Activity Survey
(N–SAS).
ICR numbers: EPA ICR No. 2293.01,
OMB Control No. 2060–NEW.
ICR status: This ICR is for a new
information collection activity. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information, unless it
displays a currently valid OMB control
number. The OMB control numbers for
EPA’s regulations in title 40 of the CFR,
after appearing in the Federal Register
when approved, are listed in 40 CFR
part 9, are displayed either by
publication in the Federal Register or
by other appropriate means, such as on
the related collection instrument or
form, if applicable. The display of OMB
control numbers in certain EPA
regulations is consolidated in 40 CFR
part 9.
Abstract: The EPA, along with State
and regional air quality regulators
support the Air Quality Index (AQI), to
notify the public of health hazards
associated with air pollution, primarily
ozone and particulate matter pollution
(PM). EPA, and specifically the Office of
Air Quality Planning and Standards,
which manages the AQI program, is
interested in assessing the public’s
awareness, knowledge and both stated
and actual behavioral response to AQI
warnings. To address this need, OAQPS
wishes to conduct the longitudinal
National-Scale Activity Surveys (N–
SAS) to gather information on the
public’s perceptions, awareness,
attitudes, and stated and actual
behaviors in response to AQI warnings.
The survey data will be used to evaluate
whether the AQI warnings effectively
inform the public about health hazards
associated with high levels of ozone and
to measure behavior change on high
ozone days. The information will also
be used to help improve outreach efforts
to this population. The survey will be
administered to a susceptible
subpopulation of concern, adults age 55
and older who engage in some level of
physical activity living in cities with
ozone pollution problems. The survey
will also be administered to a similar
sample of adults age 35 and older for
comparison purposes. The data will be
collected through a Web-based survey of
members from Knowledge Network’s
Web panel. Response to the survey is
voluntary. The respondents will be
anonymous to EPA and contractor staff
and Knowledge Networks keeps identity
of respondents confidential.
The longitudinal N–SAS consists of a
series of nine surveys. A screening
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18:23 Feb 27, 2008
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survey at the beginning and a debriefing
survey at the end will provide
information on the respondents, their
awareness and knowledge of air
pollution and the AQI, risk perceptions
regarding health effects, and reported
behaviors on high ozone days. After the
screening survey, panelists will be
administered a set of seven activity
diaries administered on both high and
low ozone days to collect information
on actual behavior.
In addition to assessing the
effectiveness of AQI-based ozone
warnings, the data will also be used to
supplement the limited data available to
develop exposure profiles for older
Americans and to identify behaviors
that may affect exposure analysis, for
example identifying populations that
report altering their behavior on high air
pollution days or reported behavior by
individuals who live in a particular area
such as near major roadways. The
responses will also provide information
for future studies of the economic
benefits of air quality improvements by
identifying behavioral changes and
other potential costs associated with
high levels of air pollution.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 0.24 hours per
response. Burden means the total time,
effort, or financial resources expended
by persons to generate, maintain, retain,
or disclose or provide information to or
for a Federal agency. This includes the
time needed to review instructions;
develop, acquire, install, and utilize
technology and systems for the purposes
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements which have subsequently
changed; train personnel to be able to
respond to a collection of information;
search data sources; complete and
review the collection of information;
and transmit or otherwise disclose the
information.
The ICR provides a detailed
explanation of the Agency’s estimate,
which is only briefly summarized here:
Estimated total number of potential
respondents: 800 complete all surveys,
1,858 starting sample size.
Frequency of response: On occasion,
up to 9 surveys total.
Estimated total average number of
responses for each respondent: 9.
Estimated total annual burden hours:
2.24 hours for each respondent to
complete all 9 surveys, for the original
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sample of 1,858 the average burden
across all respondents is 1.04 hours.
Estimated total annual costs:
$53,000. This includes an estimated
burden cost of $53,000 and an estimated
cost of $0 for capital investment or
maintenance and operational costs.
Are There Changes in the Estimates
From the Last Approval?
This is a new request.
What Is the Next Step in the Process for
This ICR?
EPA will consider the comments
received and amend the ICR as
appropriate. The final ICR package will
then be submitted to OMB for review
and approval pursuant to 5 CFR
1320.12. At that time, EPA will issue
another Federal Register notice
pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to
OMB and the opportunity to submit
additional comments to OMB. If you
have any questions about this ICR or the
approval process, please contact the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: February 20, 2008.
Karen M. Martin,
Acting Director, Health and Environmental
Impacts Division.
[FR Doc. E8–3787 Filed 2–27–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OA–2007–0976; FRL–8535–2]
Notice of Expert Peer-Review Meeting
on the Framework for Determining a
Mutagenic Mode of Action for
Carcinogenicity: Using EPA’s 2005
Cancer Guidelines and Supplemental
Guidance for Assessing Susceptibility
From Early-Life Exposure to
Carcinogens External Review Draft
Environmental Protection
Agency.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: The U.S. Environmental
Protection Agency’s (EPA or Agency)
Office of the Science Advisor (OSA) is
announcing an external peer-review
meeting to review the draft document
titled, ‘‘Framework for Determining a
Mutagenic Mode of Action for
Carcinogenicity: Using EPA’s 2005
Cancer Guidelines and Supplemental
Guidance for Assessing Susceptibility
From Early-Life Exposure to
Carcinogens’’ (or Framework). The draft
document was prepared by the
Mutagenic Mode of Action Workgroup
of EPA’s Risk Assessment Forum and
E:\FR\FM\28FEN1.SGM
28FEN1
Federal Register / Vol. 73, No. 40 / Thursday, February 28, 2008 / Notices
has recently undergone public review
and comment. Eastern Research Group,
Inc. (ERG), an EPA contractor for
external scientific review, will convene
an independent panel of experts and
organize and conduct a peer-review
meeting. The panel will review the draft
document and may consider public
comments received in the official public
docket for this activity under docket ID
number EPA–HQ–OA–2007–0976, as
well as comments made by the public at
the external peer review meeting. The
draft document and peer-review charge
are available at https://www.epa.gov/osa/
mmoaframework/index.htm. In
preparing a final document, EPA will
consider the public comments
submitted to EPA’s docket during the
public comment period, and the
comments and recommendations from
the external peer-review meeting,
including any oral public comments
made at the meeting.
EPA is releasing this draft document
solely for the purpose of predissemination peer review under
applicable information quality
guidelines. This document has not been
formally disseminated by the EPA. It
does not represent and should not be
construed to represent any Agency
policy or determination.
This notice announces the external
peer-review meeting location and dates,
and how to pre-register as an observer
and how to sign up to make oral
comments at the meeting.
DATES: The external peer-review
meeting will begin on Friday, April 4,
2008. The meeting is scheduled to begin
at approximately 8:30 a.m. and end at
approximately 5:30 p.m., Eastern Time.
Members of the public may attend the
peer-review meeting as observers. Time
will be set aside on the morning of April
4, 2008 for registered attendees who
wish to make brief oral comments (for
more information refer to the
instructions for participation below).
ADDRESSES: The peer-review meeting
will be held at the Navy League
Building, 2300 Wilson Boulevard,
Arlington, Virginia 22201.
rwilkins on PROD1PC63 with NOTICES
How Can I Request To Participate In
This Meeting?
Eastern Research Group, Inc. (ERG),
an EPA contractor for external scientific
review, will convene an independent
panel of experts and organize and
conduct a peer-review meeting to
review this draft document. To attend
the meeting, register by Tuesday, March
25, 2008 by visiting https://
www2.ergweb.com/projects/
conferences/moa/register-moa.htm. You
may also register by calling ERG’s
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18:23 Feb 27, 2008
Jkt 214001
conference line between the hours of 9
a.m. and 5:30 p.m. EST at (781) 674–
7374 or toll free at (800) 803–2833, or
by faxing a registration request to (781)
674–2906 (please reference the
‘‘Mutagenic Mode of Action PeerReview Meeting’’ and include your
name, title, affiliation, full address and
contact information), or by sending an email to Meetings@erg.com (Subject line:
Mutagenic Mode of Action Peer-Review
Meeting; Body: include your name, title,
affiliation, full address and contact
information). Pre-registration is strongly
recommended as space is limited, and
registrations will be accepted on a firstcome, first-served basis. The deadline
for pre-registration is Tuesday, March
25, 2008. If space allows, registrations
will continue to be accepted after this
date, including on-site registration.
Time will be set aside to hear comments
from observers, and individuals will be
limited to a maximum of five minutes
during the morning of the day of the
meeting. When you register, please
inform ERG that you wish to make
comments during the comment period.
FOR FURTHER INFORMATION CONTACT:
Questions regarding registration and
logistics for the external peer review
meeting should be directed to Eastern
Research Group, 110 Hartwell Avenue,
Lexington, MA 02421–3136; telephone:
(781) 674–7374 or toll-free at (800) 803–
2833; facsimile: (781) 674–2906; e-mail:
Meetings@erg.com. If you have
questions about the draft document,
please contact Dr. Kathleen Raffaele,
Office of the Science Advisor, Mail
Code 8105R, Environmental Protection
Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone
number: (202) 564–2180; fax number:
(202) 564–2070; e-mail:
raffaele.kathleen@epa.gov.
SUPPLEMENTARY INFORMATION: EPA is
submitting the draft document titled
‘‘Framework for Determining a
Mutagenic Mode of Action for
Carcinogenicity: Using EPA’s 2005
Cancer Guidelines and Supplemental
Guidance for Assessing Susceptibility
From Early-Life Exposure to
Carcinogens’’ (or Framework) for
independent, external peer review. On
September 27, 2007, the draft document
was announced in the Federal Register
and made available for a 60-day public
comment period (72 FR 54910). On
November 16, 2007, the comment
period was extended for 30 days (72 FR
64617). Public comments received in
the docket will be shared with the
external peer review panel for their
consideration. The public release of this
draft document is solely for the purpose
of seeking public comment and peer
PO 00000
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Fmt 4703
Sfmt 4703
10767
review. This draft document does not
represent and should not be construed
to represent any EPA policy, viewpoint,
or determination.
In response to requests from
numerous stakeholders following EPA’s
release of the ‘‘Supplemental Guidance
for Assessing Susceptibility from EarlyLife Exposure to Carcinogens’’ in 2005,
the Risk Assessment Forum has
prepared a framework document that
expands and clarifies characteristics
used to determine a chemical’s potential
for a mutagenic mode of action (MOA)
for carcinogenicity. This determination
affects consideration of adjusting cancer
potencies via age-dependent adjustment
factors when exposures to these
carcinogens occur in children.
The Framework is meant to
complement EPA’s 2005 ‘‘Guidelines for
Carcinogen Risk Assessment’’ (Cancer
Guidelines) and chemicals of interest
must already have a weight-of-evidence
determination for carcinogenicity. The
Framework does not provide an
approach to hazard identification.
Rather, it gives information useful to
determining whether MOAs by which
the chemical causes cancer include
mutagenicity as an early key event; ‘‘key
event’’ is a term of art described in the
MOA framework in the Cancer
Guidelines.
Dated: February 25, 2008.
George M. Gray,
EPA Science Advisor.
[FR Doc. E8–3788 Filed 2–27–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8534–6]
National Advisory Council for
Environmental Policy and Technology
Environmental Technology
Subcommittee
Environmental Protection
Agency (EPA).
ACTION: Notice of teleconference
meetings.
AGENCY:
SUMMARY: Under the Federal Advisory
Committee Act, Public Law 92463, EPA
gives notice of two teleconference
meetings of the Environmental
Technology Subcommittee of the
National Advisory Council for
Environmental Policy and Technology
(NACEPT). NACEPT provides advice
and recommendations to the
Administrator of EPA on a broad range
of environmental policy, technology,
and management issues. The
Environmental Technology
E:\FR\FM\28FEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 40 (Thursday, February 28, 2008)]
[Notices]
[Pages 10766-10767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3788]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OA-2007-0976; FRL-8535-2]
Notice of Expert Peer-Review Meeting on the Framework for
Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA's
2005 Cancer Guidelines and Supplemental Guidance for Assessing
Susceptibility From Early-Life Exposure to Carcinogens External Review
Draft
AGENCY: Environmental Protection Agency.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency)
Office of the Science Advisor (OSA) is announcing an external peer-
review meeting to review the draft document titled, ``Framework for
Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA's
2005 Cancer Guidelines and Supplemental Guidance for Assessing
Susceptibility From Early-Life Exposure to Carcinogens'' (or
Framework). The draft document was prepared by the Mutagenic Mode of
Action Workgroup of EPA's Risk Assessment Forum and
[[Page 10767]]
has recently undergone public review and comment. Eastern Research
Group, Inc. (ERG), an EPA contractor for external scientific review,
will convene an independent panel of experts and organize and conduct a
peer-review meeting. The panel will review the draft document and may
consider public comments received in the official public docket for
this activity under docket ID number EPA-HQ-OA-2007-0976, as well as
comments made by the public at the external peer review meeting. The
draft document and peer-review charge are available at https://
www.epa.gov/osa/mmoaframework/index.htm. In preparing a final document,
EPA will consider the public comments submitted to EPA's docket during
the public comment period, and the comments and recommendations from
the external peer-review meeting, including any oral public comments
made at the meeting.
EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by the
EPA. It does not represent and should not be construed to represent any
Agency policy or determination.
This notice announces the external peer-review meeting location and
dates, and how to pre-register as an observer and how to sign up to
make oral comments at the meeting.
DATES: The external peer-review meeting will begin on Friday, April 4,
2008. The meeting is scheduled to begin at approximately 8:30 a.m. and
end at approximately 5:30 p.m., Eastern Time. Members of the public may
attend the peer-review meeting as observers. Time will be set aside on
the morning of April 4, 2008 for registered attendees who wish to make
brief oral comments (for more information refer to the instructions for
participation below).
ADDRESSES: The peer-review meeting will be held at the Navy League
Building, 2300 Wilson Boulevard, Arlington, Virginia 22201.
How Can I Request To Participate In This Meeting?
Eastern Research Group, Inc. (ERG), an EPA contractor for external
scientific review, will convene an independent panel of experts and
organize and conduct a peer-review meeting to review this draft
document. To attend the meeting, register by Tuesday, March 25, 2008 by
visiting https://www2.ergweb.com/projects/conferences/moa/register-
moa.htm. You may also register by calling ERG's conference line between
the hours of 9 a.m. and 5:30 p.m. EST at (781) 674-7374 or toll free at
(800) 803-2833, or by faxing a registration request to (781) 674-2906
(please reference the ``Mutagenic Mode of Action Peer-Review Meeting''
and include your name, title, affiliation, full address and contact
information), or by sending an e-mail to Meetings@erg.com (Subject
line: Mutagenic Mode of Action Peer-Review Meeting; Body: include your
name, title, affiliation, full address and contact information). Pre-
registration is strongly recommended as space is limited, and
registrations will be accepted on a first-come, first-served basis. The
deadline for pre-registration is Tuesday, March 25, 2008. If space
allows, registrations will continue to be accepted after this date,
including on-site registration. Time will be set aside to hear comments
from observers, and individuals will be limited to a maximum of five
minutes during the morning of the day of the meeting. When you
register, please inform ERG that you wish to make comments during the
comment period.
FOR FURTHER INFORMATION CONTACT: Questions regarding registration and
logistics for the external peer review meeting should be directed to
Eastern Research Group, 110 Hartwell Avenue, Lexington, MA 02421-3136;
telephone: (781) 674-7374 or toll-free at (800) 803-2833; facsimile:
(781) 674-2906; e-mail: Meetings@erg.com. If you have questions about
the draft document, please contact Dr. Kathleen Raffaele, Office of the
Science Advisor, Mail Code 8105R, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-2180; fax number: (202) 564-2070; e-mail:
raffaele.kathleen@epa.gov.
SUPPLEMENTARY INFORMATION: EPA is submitting the draft document titled
``Framework for Determining a Mutagenic Mode of Action for
Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental
Guidance for Assessing Susceptibility From Early-Life Exposure to
Carcinogens'' (or Framework) for independent, external peer review. On
September 27, 2007, the draft document was announced in the Federal
Register and made available for a 60-day public comment period (72 FR
54910). On November 16, 2007, the comment period was extended for 30
days (72 FR 64617). Public comments received in the docket will be
shared with the external peer review panel for their consideration. The
public release of this draft document is solely for the purpose of
seeking public comment and peer review. This draft document does not
represent and should not be construed to represent any EPA policy,
viewpoint, or determination.
In response to requests from numerous stakeholders following EPA's
release of the ``Supplemental Guidance for Assessing Susceptibility
from Early-Life Exposure to Carcinogens'' in 2005, the Risk Assessment
Forum has prepared a framework document that expands and clarifies
characteristics used to determine a chemical's potential for a
mutagenic mode of action (MOA) for carcinogenicity. This determination
affects consideration of adjusting cancer potencies via age-dependent
adjustment factors when exposures to these carcinogens occur in
children.
The Framework is meant to complement EPA's 2005 ``Guidelines for
Carcinogen Risk Assessment'' (Cancer Guidelines) and chemicals of
interest must already have a weight-of-evidence determination for
carcinogenicity. The Framework does not provide an approach to hazard
identification. Rather, it gives information useful to determining
whether MOAs by which the chemical causes cancer include mutagenicity
as an early key event; ``key event'' is a term of art described in the
MOA framework in the Cancer Guidelines.
Dated: February 25, 2008.
George M. Gray,
EPA Science Advisor.
[FR Doc. E8-3788 Filed 2-27-08; 8:45 am]
BILLING CODE 6560-50-P
