Technical Peer Review Workshop on the Draft Document Entitled A Review of the Reference Dose and Reference Concentration Processes

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of meeting.

SUMMARY:

EPA is announcing a meeting, organized and convened by Versar, Inc., a contractor to EPA's Risk Assessment Forum, for external scientific peer review of the draft document entitled, A Review of the Reference Dose and Reference Concentration Processes (EPA/630/P-02/002A). The purpose of the meeting is to discuss technical issues associated with the Risk Assessment Forum Reference Dose/Reference Concentration (RfD/RfC) Technical Panel recommendations. The draft document is not a guidance document but an analysis and review of the current RfD/RfC process and a series of recommendations to improve the process. Final decisions on implementing any of the recommendations from the Technical Panel will be made by the Agency's Science Policy Council. The EPA also is announcing a 30-day public comment period for the draft document. EPA will consider the peer review advice and public comment submissions in revising the document.

DATES:

The peer review meeting will be held from 8:00 a.m. to 5:00 p.m. on Wednesday, June 19, 2002. The 30-day public comment period begins June 4, 2002, and ends July 5, 2002. Technical comments should be in writing and must be postmarked by July 5, 2002.

ADDRESSES:

The meeting will be held at the Key Bridge Marriott, 1401 Lee Highway, Arlington, VA 22209. Versar, Inc., an EPA contractor, will convene and facilitate the workshop. To register to attend the workshop as an observer, visit www.versar.com/epa/rfdrfcreview.htm,, or contact Ms. Traci Bludis, Versar, Inc.; telephone: (703) 750-3000 extension 449; facsimile: 703-642-6954; e-mail bluditra@versar.com by 5 p.m. eastern daylight time, June 14, 2002. The draft document, A Review of the Reference Dose and Reference Concentration Processes, is available via the Internet on the Risk Assessment Forum Publications home page at http://www.epa.gov/ncea/raf/rafpub.htm under What's New. Copies are not available from Versar Inc.

Public comments may be mailed to the Technical Information Staff (8623D), NCEA-W, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460, or delivered to the Technical Information Staff at 808 17th Street, NW, 5th Floor, Washington, DC 20006; telephone: 202-564-3261; facsimile: 202-565-0050.

FOR FURTHER INFORMATION CONTACT:

For further information concerning the technical peer review workshop or the draft document, A Review of the Reference Dose and Reference Concentration Processes, please contact Marilyn Brower, U.S. EPA Office of Research and Development (8601-D), 1200 Pennsylvania Ave. NW, Washington, DC 20460; Telephone: (202) 564-3363; Fax: (202) 565-0062; e-mail: brower.marilyn@epa.gov.

SUPPLEMENTARY INFORMATION:

The RfD/RfC Technical Panel (hereafter the Technical Panel) was established in response to a request from the Agency's 10X Food Quality Protection Act Task Force to the Science Policy Council and the Risk Assessment Forum. A draft toxicology report developed by the 10X Task Force raised a number of issues that relate to the derivation of the oral reference dose (RfD) and inhalation reference concentration (RfC). The Science Policy Council and the Risk Assessment Forum agreed that these issues should be examined on a broader scale than just for pesticides, with input from various program offices within the Agency and from the outside scientific/policy community. This charge was expanded by the Forum to include a more in-depth review of a number of issues related to the RfD/RfC process, in part because of several other Forum activities that were underway (e.g., development of the Framework for the Harmonization of Cancer and Noncancer Risk Assessment, revision of the Benchmark Dose Guidance Document, and revision of the Guidelines for Carcinogen Risk Assessment). In addition, the RfD/RfC derivation process had not been evaluated in detail for a number of years, and several scientific issues concerning children's health, e.g., neurotoxicity and immunotoxicity, have become increasingly important in risk assessment. These activities have prompted the need to re-examine the RfD/RfC process and to coordinate these efforts with other related activities. In particular, it was important that efforts continue to focus on moving toward the goal of harmonization of risk assessment approaches for all health endpoints and making efficient use of animal testing to achieve this goal.

The draft report entitled, A Review of the Reference Dose and Reference Concentration Processes is not a guidance document but represents an analysis of the current RfD/RfC processes. The draft report summarizes the review and deliberations of the Technical Panel and presents a number of recommendations to improve the RfD/RfC processes. The review further documents recommendations that should be considered in the implementation of changes in the current process and/or development of needed guidance. The peer reviewers are being asked to review the recommendations of the Technical Panel and to provide comments regarding the scientific rationale for the recommendations. Comments from the external peer reviewers and the public will help inform the process.