These guidelines revise and replace the U.S. Environmental Protection Agency's (EPA's, or the Agency's) Guidelines for Carcinogen Risk Assessment, published in 51 FR 33992, September 24, 1986 (U.S. EPA, 1986a) and the 1999 interim final guidelines (U.S. EPA, 1999a; see U.S. EPA 2001b). They provide EPA staff with guidance for developing and using risk assessments. They also provide basic information to the public about the Agency's risk assessment methods

EPA/630/P-03-001B. Includes bibliographical references (R-1-R-18).

Introduction -- Purpose and scope of the guidelines -- Organization and application of the guidelines -- Key features of the Cancer guidelines -- Hazard assessment -- Overview of hazard assessment and characterization -- Analysis of tumor data -- Analysis of other key data -- Mode of action: general considerations and framework for analysis -- Weight of evidence narrative -- Hazard characterization -- Dose-response assessment -- Analysis of dose -- Analysis in the range of observation -- Extrapolation to lower doses -- Extrapolation to different human exposure scenarios -- Extrapolation to susceptible populations and lifestages -- Uncertainty -- Dose-response characterization -- Exposure assessment -- Defining the assessment questions -- Selecting or developing the conceptual and mathematical models -- Collecting data or selecting and evaluating available data -- Exposure characterization -- Risk characterization -- Purpose -- Application -- Presentation of the risk characterization summary -- Content of the risk characterization summary -- Appendix: Major default options -- Appendix B: EPA's guidance for data quality assessment -- References.