E9-19755. Availability of the External Peer Review Draft of Using Probabilistic Methods To Enhance the Role of Risk Analysis in Decision-Making With Case Study Examples

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of document availability for public comment.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is announcing a 15-day public comment period for the external peer review draft of “Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making With Case Study Examples,” a white paper, and the “Manager's Summary” of the same document. All comments received by the closing date of September 1, 2009 will be shared with the external peer review panel for their consideration. Comments received after the close of the comment period may be considered by EPA when it finalizes the document. These draft interim papers do not represent and should not be construed to represent any EPA policy, viewpoint, or determination. Members of the public may obtain the draft documents from http://www.regulations.gov;​; or http://www.epa.gov/​raf/​prawhitepaper;​; or from Gary Bangs via the contact information below.

EPA will convene a panel of invited experts to review the draft document. The external expert peer review will be conducted by letter and closed teleconference in the May 2009 time frame. The panel may consider public comments received in the official public docket for this activity under docket ID number EPA-HQ-ORD-2009-NNNN. The draft documents and peer-review charge are available at http://www.epa.gov/​raf/​prawhitepaper. In preparing a final document, EPA will consider the public comments submitted to EPA's docket during the public comment period as well as the comments and recommendations from the external peer-reviewers.

EPA is releasing these draft documents solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. These documents have not been formally disseminated by the EPA. They do not represent and should not be construed to represent any Agency policy or determination.

DATES:

All comments received by September 1, 2009 will be shared with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA when it finalizes the documents.

ADDRESSES:

The draft documents are available electronically through the EPA Office of the Science Advisor's Web site at: http://www.epa.gov/​raf/​prawhitepaper.

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-NNNN, by one of the following methods:

• Online at: http://www.regulations.gov;​; Follow the on-line instructions for submitting comments.
• E-mail: [e-mail].
• Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-ORD-2009-NNNN. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2009-NNNN. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov,, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected by statute through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA, without going through http://www.regulations.gov,, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy.

Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPAWest, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the ORD Docket is [phone].

FOR FURTHER INFORMATION CONTACT:

Gary Bangs, Risk Assessment Forum, Mail Code 8105R, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone], E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Various stakeholders, inside and outside the Agency, have called for a more comprehensive characterization of risks, including uncertainties, in protecting more sensitive or vulnerable populations and life stages. Therefore, the Office of the Science Advisor of the EPA, together with EPA's Science Policy Council and members of EPA's Risk Assessment Forum (RAF), identified a need to examine the use of probabilistic approaches in Agency risk assessment and risk management. An RAF Technical Panel developed this paper and the manager's summary to provide a general overview of the value of probabilistic analyses and similar or related methods, and some examples of current applications across the Agency. The purpose of these papers is not only to describe potential and actual uses of these tools in the risk decision process, but also to encourage their further implementation in human, ecological and environmental risk analysis and related decision making. The enhanced use of probabilistic analyses to characterize uncertainty in assessments would not only reflect external scientific advice on how to further advance EPA risk assessment science, but will also help to address specific challenges faced by managers and improve confidence in Agency decisions. The draft document was prepared by the Probabilistic Risk Analysis Technical Panel of EPA's Risk Assessment Forum and has undergone internal peer review.

Dated: August 4, 2009.

Kevin Teichman,

Acting EPA Science Advisor.