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EPA Seeks to Update Guideline for Cancer Risk Assessment -- Agency Bases Draft Guideline Revisions On Both Public Health Protectiveness and Scientific Soundness Draft Supplemental Guidance on Risks from Early-life Exposure Also Issued

Release Date: 03/03/2003
Contact Information:

CONTACT: David Deegan, 202-564-7839

(03/03/03) In an effort to update key scientific risk assessment methodologies, EPA has released for public review and comment draft final guidelines for cancer risk assessment, as well as a supplemental guidance for assessing early-life exposure to carcinogens. The release of these draft documents, announced by Dr. Paul Gilman, the Science Advisor to the EPA Administrator and the Assistant Administrator for the Agency’s Office of Research and Development, is an important step in EPA’s revision of cancer risk assessment guidelines first published in 1986. These guidelines provide a framework for EPA scientists to assess possible cancer risks from exposures to environmental pollutants.

EPA has been working to revise the 1986 guidelines in light of significant advances in scientific understanding of how cancer may be caused. EPA’s guiding principle for revisions to the cancer guidelines is that Agency cancer risk assessments be both public health protective and scientifically sound. The draft guidelines have also previously been the subject of public review and independent scientific peer review. Today’s draft document reflects many of the comments and suggestions provided to EPA by various reviewers.

Because the draft final “Guidelines for Carcinogen Risk Assessment” recommend consideration of possible sensitive subpopulations and lifestages (such as childhood), EPA is also releasing for public comment a draft “Supplemental Guidance for Assessing Cancer Susceptibility from Early-Life Exposure to Carcinogens.” The draft supplemental guidance is part of EPA’s response to a 1994 recommendation by the National Research Council that “EPA should assess risks to infants and children whenever it appears that their risks might be greater than those of adults.” Following public review and comment, this draft supplemental guidance will be peer reviewed by EPA’s Science Advisory Board which is comprised of a distinguished body of non_governmental experts drawn from academia, industry, and environmental communities.

The draft final cancer guidelines reflect EPA’s evolving approach to cancer risk assessment, resulting from both significant strides in scientific knowledge and in EPA’s experience in applying risk assessment principals and practices. Both the draft final guidelines and the draft supplemental guidance reflect the considerable increase in our fundamental knowledge of the biological processes of cancer, and are expected to enhance EPA’s ability to more accurately assess the carcinogenic potential of environmental contaminants.

Both the draft final guidelines and the draft supplemental guidance are available at: .