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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

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Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 Start Printed Page 10767has 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.

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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.

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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.

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Dated: February 25, 2008.

George M. Gray,

EPA Science Advisor.

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[FR Doc. E8-3788 Filed 2-27-08; 8:45 am]

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