Abstract of Meeting Paper

Society for Risk Analysis 1997 Annual Meeting

Review of the Proposed USEPA Cancer Risk Assessment Guidelines. S. R. Baker, 2423 McCormick Road, Rockville, MD 20850; and B. R. Stern, EA Engineering, Science, and Technology, Inc., 8401 Colesville Road, Suite 500, Silver Spring, MD 20910

The USEPA has proposed new guidelines for the assessment of cancer risk. This presentation will address the technical substance of these guidelines and their departure from the 1986 guidelines. This will include:

1. Use of the LED10 as a point of departure for low-dose extrapolation, and distinctions between the range of observed data and the range of extrapolation,
2. Linear and nonlinear treatments at low doses,
3. Departure from default assumptions and procedures,
4. New descriptors for cancer classification, and
5. Role of mode-of-action information in shaping the dose-response relationship.

The current status of the guidelines will be presented. To provide perspective on the guidelines’ current approach and content, significant issues and the resolutions that shaped their development will be reviewed. Potential pitfalls in the misapplication of the guidelines will be discussed.