Workshop Report on EPA Guidelines for Carcinogen Risk Assessment
Risk Assessment Forum
In 1986, EPA issued guidelines for assessing human risk from exposure to environmental carcinogens. The guidelines set forth principles and procedures to guide EPA scientists in the conduct of Agency risk assessments, to promote high scientific quality and Agency-wide consistency, and to inform Agency decision-makers and the public about these scientific procedures. As expected, new information and thinking in several areas of carcinogen risk assessment, as well as accumulated experience in using the guidelines, has led to an EPA review of the need for revisions to the guidelines. This Workshop (and a subsequent workshop on use of human evidence) completed the first of a three-stage review process, with the first stage involving information gathering activities to identify and define scientific issues relating to the guidelines. For the Workshop, EPA assembled experts in various aspects of carcinogen risk assessment to study and comment on the scientific foundation for two general aspects of the guidelines: "qualitative" issues bearing on the classification of chemicals as potential carcinogens and "quantitative" questions on extrapolating data from test animals to human populations. In the second stage of the guidelines review, EPA will analyze the information and develop a formal proposal. In the third stage, proposed changes will be subject to scientific peer review and public comment. [Note: EPA published Proposed Guidelines for Carcinogen Risk Assessment in 1996; the draft and more recent versions are available from EPA.]
Discussion at the workshop revolved around the following five pre-meeting issue papers:
Qualitative Evidence Issues
- Relevance of tumors in animals to human carcinogenicity
- Weight-of-evidence classification scheme
Quantitative Evidence Issues
- Dose scaling across species
- Incorporation of mechanistic data into quantitative risk assessment
- Additivity/independence of mechanism to background processes
Contact: Risk Assessment Forum Staff, 202-564-6483, or email@example.com
- Proposed Guidelines for Carcinogen Risk Assessment
- Draft Revised Guidelines for Carcinogen Risk Assessment (External Draft, July 1999)
- Workshop Report on EPA Guidelines for Carcinogen Risk Assessment: Use of Human Evidence
Note: a complete electronic version of this document that preserves its original appearance (such as in a pdf file format) is not currently available. However, a scanned version is available in image or text format from EPA's National Environmental Publications Information System. Paper copies may be ordered from the National Technical Information Service.
The most current draft of the cancer guidelines, Draft Final Guidelines for Carcinogen Risk Assessment is also available online. As announced in the Federal Register on November 29, 2001, the July 1999 draft Revised Guidelines for Carcinogen Risk Assessment will continue to serve as EPA's interim guidance to EPA risk assessors preparing cancer risk assessments until final Guidelines are issued.
US EPA. Workshop Report on EPA Guidelines for Carcinogen Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/625/3-89/015, 1989.