Daily Rules, Proposed Rules, and Notices of the Federal Government



Notification of an External Peer Review Meeting for the DraftFramework for Human Health Risk Assessment to Inform Decision Making

AGENCY: U.S. Environmental Protection Agency.
ACTION: Notice of an external peer review meeting.
SUMMARY: The EPA Office of the Science Advisor announces that Versar, Inc., a contractor to the EPA, will convene an independent panel of experts to review the draft document,Framework for Human Health Risk Assessment to Inform Decision Making. Any member of the public may register to attend this peer review meeting as an observer. Time will be set aside for observers to give brief oral comments on the draft document at the meeting. The draft document is available via the internet on the Risk Assessment Forum web page (
DATES: The peer review panel meeting on the draft document,Framework for Human Health Risk Assessment to Inform Decision Makingwill be held on October 9, 2012, from 9:00 a.m. to approximately 5:00 p.m. Eastern Daylight Time, with registration beginning at 8:30 a.m.
ADDRESSES: Internet:The draft document can be downloaded from

Instructions:To attend the peer review meeting as an observer, register no later than October 2, 2012 by calling Kathy Coon at Versar, Inc., on (703) 750-3000 ext. 545 or toll free on (800) 283-7727; sending a facsimile to (703) 642-6809 (subject line: HHRA Framework Meeting; and include your name, title, affiliation, full address and contact information in the body of the facsimile), or sending an email line: HHRA Framework Meeting; and include your name, title, affiliation, full address and contact information in the body of the email). Space is limited, and registrations will be accepted on a first-come, first-served basis. There will be a limited time for comments from the public at the peer review meeting. Please inform Versar, Inc., in your registration request, if you wish to make oral comments during the meeting.

FOR FURTHER INFORMATION CONTACT: Julie Fitzpatrick, Office of the Science Advisor, Mail Code 8105-R, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-4212; fax number: (202) 564-2070,

The EPA has an established history of conducting human health risk assessments. The finalFrameworkis intended to foster increased implementation of existing agency guidance for conducting human health risk assessments and improve the utility of risk assessment in the decision-making process.

In developing the draftFramework,the relevant recommendations presented in the National Research Council's reportScience and Decisions: Advancing Risk Assessmenthave been taken into consideration. Specifically, the recommendations that the EPA formalize and implement planning, scoping and problem formulation early in the risk assessment process and that the agency adopt a framework for risk-based decision-making are included in thisFramework.

The draftFrameworkhighlights the important roles of planning and scoping as well as problem formulation in designing a human health risk assessment process. In accord with long-standing agency policy, it also emphasizes the importance of both scientific review and public involvement. TheFrameworkpresents the concept of “fit for purpose” to address the development of risk assessments and associated products that are for informing risk management decisions. The finalFrameworkwill also highlight the agency's emphasis on the importance of transparency in human health risk assessment and decision-making processes.

This document is not intended to supersede existing agency guidance; instead, by citing and discussing existing guidance in the context of the proposed framework, it is intended to foster more effective implementation of that guidance.

The EPA previously announced the release of the draftFrameworkfor a 60 day comment period (77 FR 44613), which ends on September 28, 2012. Public comments submitted during the public comment period may be viewed athttp://www.regulations.govunder Docket ID No. EPA-HQ-ORD-2012-0579. The EPA will forward all public comments to Versar, Inc., for distribution to the members of the review panel. The external review draft does not represent agency policy. As it finalizes the draft document, the EPA intends to consider the comments from the external peer review meeting, along with public comments received by September 28, 2012, in accordance with 77 FR 44613.

Dated: September 6, 2012. Glenn Paulson, Science Advisor.