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]

Download as PDF 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 VerDate Aug<31>2005 18:23 Feb 27, 2008 Jkt 214001 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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 http://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 VerDate Aug<31>2005 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 Frm 00029 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 28FEN1

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]


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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 http://
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