EPA Issues Cancer Risk Assessment Guidelines

March 29, 2005

Two documents released today provide principles and procedures to guide EPA scientists assessing cancer risk from exposures to environmental pollutants.

The documents, "Guidelines for Carcinogen Risk Assessment (Cancer Guidelines)," and "Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens (Supplemental Guidance)" reflect EPA's evolving approach to cancer risk assessment. The guidelines are prospective only and will apply to the agency's current and future risk assessments of environmental pollutants.

"These guidelines will help us apply the most up-to-date science and to incorporate new science as it becomes available in assessing the risks associated with environmental exposures to carcinogens," said Acting Assistant Administrator for the Office of Research and Development Tim Oppelt. "EPA's guiding principle is that our cancer risk assessments be public health protective."

The new cancer guidelines result from significant strides in scientific knowledge, and in EPA's 20-plus years of experience in applying risk assessment principles and practices. The cancer guidelines were last revised in 1986.

The cancer guidelines issued today set forth a revised set of recommended principles and procedures to guide EPA scientists and others in assessing the cancer risks resulting from exposure to chemicals or other agents in the environment.

These guidelines are also used to inform agency decision makers and the public about risk assessment procedures.

The additional Supplemental Guidance describes possible approaches that EPA could use in assessing cancer risks exposures to children from 0 to 16 years of age.

This marks the first time that Supplemental Guidance specifically related to children has been issued. It includes a review of existing scientific literature on chemical effects in animals and humans.

The Supplemental Guidance also summarizes the results of the cancer studies that investigated early-life exposure, EPA's analysis of those studies, and analysis to strengthen the scientific basis for adjusting from studies conducted in adults to children.

This document is consistent with the National Research Council's 1994 recommendation that "EPA assess risks to infants and children whenever it appears that their risks might be greater than those of adults."

The draft cancer guidelines and draft Supplemental Guidance were announced in the Federal Register on March 3, 2003.

Both documents issued as final today have undergone extensive public comment and independent scientific peer review.

Source: EPA