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Draft Final Guidelines for Carcinogen Risk Assessment (External Review Draft, February 2003)

Risk Assessment Forum
Federal Register Notices

On March 29, 2005 EPA issued final Guidelines for Carcinogen Risk Assessment, along with an associated document entitled Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. Both documents are available at Guidelines for Carcinogen Risk Assessment (2005).

The related draft document entitled Supplemental Guidance for Assessing Cancer Susceptibility Resulting from Early-Life Exposure to Carcinogens is also available online.

In 1986, EPA published a set of risk assessment guidelines, including Guidelines for Carcinogen Risk Assessment (PDF) (38 pp, 162KB, about PDF) . These Guidelines set forth principles and procedures to guide EPA scientists in assessing the cancer risks from chemicals or other agents in the environment and to inform the public about these procedures. EPA continues to revise its risk assessment guidelines and to develop new guidelines as experience and scientific understanding evolve. EPA has designed its risk assessment guidelines to be flexible enough to accommodate future scientific advances in science and risk assessment practices. Because this current draft has already benefitted from extensive public comment and multiple rounds of expert scientific review by EPA's Science Advisory Board, the Agency is requesting that public comments focus on discussions of specific science issues that are substantively revised or newly addressed since the publication of the 1999 revised draft cancer guidelines.

Prior Revisions: As part of the revisions process, the Agency published Proposed Guidelines for Carcinogen Risk Assessment (425 pp, 163KB, about PDF) in 1996 (61 FR 17960, Apr. 23, 1996). The draft revisions have been subject to extensive public comment and scientific peer review, including three reviews by EPA's Science Advisory Board. In 2001, EPA published a notice (66 FR 59593, Nov. 29, 2001) providing an additional opportunity for public comment on a 1999 draft of the Guidelines. Comments were invited on experience gained in applying previous draft revised Guidelines and on specific issues raised in previous comments by the SAB and the public.

2003 Draft Final Guidelines: As announced in the Federal Register on March 3, 2003, the Draft Final Guidelines for Carcinogen Risk Assessment are being made available for public comment. A subsequent Federal Register Notice published April 14, 2003 extended the public comment period to June 2, 2003. EPA's guiding principle for revisions is that Agency cancer risk assessments be both public health protective and scientifically sound. In particular, the revisions to the Guidelines are intended to make greater use of the increasing scientific understanding of the mechanisms that underlie the carcinogenic process. EPA is especially interested in public comments on the following areas: 1) use of default options; 2) hazard descriptors; 3) mode of action; 4) extrapolation to lower doses; and 5) susceptible populations and lifestages. At the same time, EPA is making available for public comment draft Supplemental Guidance describing possible approaches that could be used to assess risks resulting from early life exposure to potential carcinogens.

Contact: Risk Assessment Forum Staff, 202-564-6483, or risk.forum@epa.gov

Downloads/Related Links

Related Links

Additional Information

Per the April 14, 2003 Federal Register Notice,the public comment period closed June 2, 2003. Comments may be viewed by selecting "search" and then keying in the docket identification number OAR-2003-0008 at EPA Dockets.


Draft Final Guidelines for Carcinogen Risk Assessment (External Review Draft, February 2003). U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 2003.

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