2011-22660. External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing that Eastern Research Group, Inc. (ERG), a contractor to the EPA, will convene an independent panel of experts to review the draft document, “Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation.” EPA previously announced the release of the draft guidance for a 45 day comment period (76 FR 33752-33753), which was subsequently extended to 60 days (76 FR 43999). The public comment period ended August 9, 2011. EPA intends to forward public comments to the contractor for distribution to members of the review panel. The external review draft does not represent Agency policy.

The public may register to attend this peer review meeting as observers. Time will be set aside for observers to give brief oral comments at the meeting on the draft document. The draft document and appendix are available via the internet on the Risk Assessment Forum Web page (http://www.epa.gov/​raf/​DDEF/​index.htm). When finalizing the draft document, EPA intends to consider the comments from the external peer review meeting along with public comments received by August 9, 2011 in accordance with 76 FR 33752-33753 and 76 FR 43999. Public comments submitted during the public comment period ending August 9, 2011, may be viewed at http://www.regulations.gov under Docket ID No. EPA-HQ-ORD-2009-0694.

DATES:

The peer review panel meeting on the draft document, “Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation” will be held on Monday, September 12, 2011, beginning at 8:30 a.m. and ending at 5 p.m. Eastern Daylight Time.

ADDRESSES:

The meeting will be held at the following location: L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024.

Instructions: To attend the peer review meeting as an observer register no later than September 5, 2011, call ERG at [phone] or toll free at [phone] (the DDEF peer review coordinator is Laurie Waite); or send a facsimile to [phone] (reference the “DDEF Peer Review Meeting” and include your name, title, affiliation, full address and contact information), or send an e-mail to [e-mail] (reference the “DDEF Peer Review Meeting” and include your name, title, affiliation, full address and contact information). Internet registration is available at https://www2.ergweb.com/​projects/​conferences/​peerreview/​register-ddef.htm. Space is limited, and registrations will be accepted on a first-come, first-served basis. There will be a limited time at the peer review meeting for comments from the public. Please inform ERG if you wish to make oral comments during the meeting.

Information on Services for Individuals with Disabilities: EPA welcomes public attendance at the DDEF Peer Review Meeting and will make every effort to accommodate persons with disabilities. For information on access or services for individuals with disabilities, call ERG by calling [phone] or toll free at [phone] and speak to Laurie Waite; or send a facsimile to [phone] (reference the “DDEF Peer Review Meeting” and include your name and contact information), or send an e-mail to [e-mail] (reference the “DDEF Peer Review Meeting” and include your name and contact information).

FOR FURTHER INFORMATION CONTACT:

Dr. Michael W. Broder, Risk Assessment Forum, Office of the Science Advisor (8105R) at the following address: U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. His telephone number is [phone]. His e-mail address is [e-mail].

Internet: The draft document can be downloaded from http://www.epa.gov/​raf/​DDEF/​index.htm

SUPPLEMENTARY INFORMATION:

This draft document outlines approaches for developing factors for interspecies and intraspecies extrapolation based on data describing toxicokinetics and/or toxicodynamics properties of particular chemical agent(s). It was developed to provide guidance for EPA staff in evaluating such data and/or information and to inform the regulated community and other interested parties about emerging EPA approaches to employ data to address areas of uncertainty.

Dated: August 30, 2011.

Paul T. Anastas,

EPA Science Advisor.