Document ID: EPA-HQ-OA-2007-0976-0020
Agency: epa
Document Type: Notice
Title: Notice of Expert Peer-Review Meeting on the Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPAs 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility From Early-Life Exposure to Carcinogens External Review Draft
Posted Date: 2008-02-28T05:00Z

[Federal Register: February 28, 2008 (Volume 73, Number 40)]
[Notices]               
[Page 10766-10767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe08-65]                         

-----------------------------------------------------------------------

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