[Federal Register Volume 61, Number 168 (Wednesday, August 28, 1996)] [Notices] [Page 44308] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-21943] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-5601-3] Benchmark Dose Peer Consultation Workshop AGENCY: U.S. Environmental Protection Agency. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: The EPA's Risk Assessment Forum is organizing a workshop on the use of the Benchmark Dose approach in cancer and noncancer risk assessments. A panel consisting of experts will discuss general principles related to the application of the Benchmark Dose approach as discussed in the EPA draft report Benchmark Dose Technical Guidance Document (EPA/600/P-96/002A). This draft guidance document is currently under development, but is being made available at this stage for a peer consultation workshop. Several experts in the areas of toxicology, statistics, and mathematical modeling have been asked to review the document and provide input at this early stage of development on several issues for which there is ongoing discussion within the Agency. The workshop will be open to members of the public as observers. DATES: The meeting will begin on Tuesday, September 10, 1996, at 8:00 a.m. and end on Wednesday, September 11, 1996, at 3:00 p.m. ADDRESSES: The meeting will be held at the Holiday Inn Bethesda, 8120 Wisconsin Avenue, Eastern Research Group, Inc., an EPA contractor, is providing logistical support for the workshop. To attend the workshop as an observer, contact Eastern Research Group, Inc., Tel: (617) 674- 7474 by September 2, 1996. Space is limited so please register early. FOR FURTHER INFORMATION CONTACT: For further information concerning the workshop, please contact Dr. Carole Kimmel, U.S. EPA, Office of Research and Development, 401 M Street, S.W., Washington, D.C., Telephone (202) 260-7331. To obtain a copy of the document, contact ORD Publications, Technology Transfer and Support Division, National Risk Management Laboratory, Cincinnati, OH; telephone 513-569-7562; fax: 513-569-7566. The document should be available on or about August 20, 1996. SUPPLEMENTARY INFORMATION: The US EPA conducts risk assessments for an array of non-cancer health effects as well as for cancer. Historically, dose-response analysis has been done very differently, but with the recent publication of EPA's Proposed Guidance for Carcinogen Risk Assessment (61 FR 17960-18011), the dichotomy between quantitative approaches for cancer and noncancer risks will begin to breakdown. The EPA is exploring the use of the Benchmark Dose approach as a way of modeling effects data in the observable range and determining the point of departure that can be used as the basis for linear low-dose extrapolation, calculation of a margin of exposure (MOE), or application of uncertainty factors for calculating oral reference doses (RfDs), inhalation reference concentrations (RfCs), or other exposure estimates for human health risk assessment. Issues to be discussed at the workshop include: the appropriate selection of studies and responses for benchmark dose analysis, use of biological significance or limit of detection for selection of the benchmark response, model selection and fitting, use of the lower confidence limit, and the default decision approach proposed in the document. Dated: August 16, 1996. Joseph Alexander, Acting Assistant Administrator for Research and Development. [FR Doc. 96-21943 Filed 8-27-96; 8:45 am] BILLING CODE 6560-50-M