Assessing the Impact of EPA’s New Guidelines for Carcinogen Risk Assessment

By Christopher P. Davis (Goodwin Procter) and Russell E. Keenan, PH.D. (AMEC Earth & Environmental, Inc.)

Originally published July 2005

In March, 2005, EPA released its final Guidelines for Carcinogen Risk Assessment (Final Guidelines). These guidelines represent the culmination of a long development process, replacing EPA’s original cancer risk assessment guidelines (1986) and its interim final guidelines (1999). The changes in the Final Guidelines purportedly reflect public comments on earlier versions, as well as advances in scientific understanding of toxicology, chemical carcinogenesis, and principles of risk assessment. Because the Final Guidelines will provide the foundation for carcinogenic risk assessment for years to come, they will drive future evaluations of whether particular chemicals are likely to cause cancer in humans, and the extent to which site-specific exposure scenarios pose carcinogenic risks. Thus, the Guidelines will have far reaching implications for