FACT SHEET: EPA ISSUES UPDATED CANCER GUIDELINES AND SUPPLEMENTAL GUIDANCE ON RISKS FROM EARLY-LIFE EXPOSURE
ACTIONS: The U.S. Environmental Protection Agency has issued the final Guidelines for Carcinogen Risk Assessment, along with an associated document entitled Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. These revised and updated Guidelines provide a framework to EPA scientists for assessing possible cancer risks from exposures to environmental pollutants. These documents are a revision of the cancer risk assessment guidelines previously published in 1986.
SUMMARY: EPA updates, revises and publishes guidelines to assist risk assessors within EPA and outside in evaluating the risks of environmental hazards. The guidelines were developed to promote high technical and scientific quality and Agency-wide consistency in the risk assessment process. The cancer guideline documents specifically address the assessment of cancer risks. EPA began the revision of the 1986 cancer guidelines in light of significant scientific advances in our understanding of the biological processes of cancer and the causes of disease at the cellular level. The guidelines are meant to be dynamic, flexible documents that can evolve to reflect the current state of the science and risk assessment practices. Both documents underwent extensive public comment and expert scientific peer review.
Cancer Risk Assessment Guidelines:
The Cancer Guidelines 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. The guidelines are also used to inform Agency decision makers and the public about risk assessment procedures.
EPA's guiding principle in its revision of the Cancer Guidelines is that EPA cancer risk assessments be public health protective and scientifically sound. To be public health protective, risk assessments consider a range of susceptibilities among the human population and, in the absence of complete knowledge, employ assumptions that will reflect the risks to susceptible subpopulations and lifestages. To be scientifically sound, risk assessments reflect current and evolving scientific practices and describe risks in a clear, consistent, and reasonable manner. In particular, the updated Cancer Guidelines are intended to promote greater use of the increasing scientific understanding of the biological mechanisms that underlie the carcinogenic process.
Supplemental Guidance on Risks from Early-life Exposure:
This Supplemental Guidance describes possible approaches that EPA could use in assessing cancer risks following exposures to children from 0 to 16 years of age. 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, along with EPA's analysis of those studies and evaluates how early life exposures to mutagenic compounds may lead to increases in cancer risks in later life.
The Supplemental Guidance was issued separately from the Cancer Guidelines so that it may be more easily updated as scientific understanding about effects of early life exposures evolve. In addition, because the areas of carcinogenicity, genesis of disease, and effects on susceptible life stages and populations are constantly and quickly evolving, EPA expects that this will be the first of several supplemental guidance documents to the Guidelines. These companion documents will provide additional information on how to address certain aspects of children's risk to the cancer causing effects of some chemicals.
BACKGROUND: On September 24, 1986, EPA issued risk assessment guidelines relating to five areas: carcinogenicity, mutagenicity, chemical mixtures, developmental toxicants, and estimating exposures (www.epa.gov/ncea/raf/rafguid.htm). Since 1986, EPA has applied the Guidelines for Carcinogen Risk Assessment to hundreds of environmental agents. The results of many of these cancer hazard and dose-response assessments can be found on the Agency's Integrated Risk Information System (IRIS) database (www.epa.gov/iris). Other assessments are maintained separately within individual EPA programs (e.g., certain pesticides). The scientific information contained in IRIS and the other assessments is used to support Agency decisions.
Over the years, EPA has revised and updated several of the 1986 guidelines, and has developed risk guidelines for other health endpoints such as neurotoxicity. EPA continues to revise its risk assessment guidelines and to develop new guidelines as experience and scientific understanding evolve.
DOCUMENT AVAILABILITY:
Guidelines for Carcinogen Risk Assessment:
The primary method for document availability is via the Internet at www.epa.gov/cancerguidelines. In addition, the full text of the updated Cancer Guidelines is included in the Federal Register. A limited number of paper copies and CD-ROM copies will be available from: EPA's National Service Center for Environmental Publications (NSCEP), P.O. Box 42419,Cincinnati, OH 45242; telephone: 1 (800) 490-9198 or (513) 489-8190; facsimile: (513) 489-8695. Please provide your name, your mailing address, the title and the EPA number of the requested publication (EPA/630/P-03-001F).
Supplemental Guidance Document:
The primary method for document availability is via the Internet at www.epa.gov/cancerguidelines. Also, data and analyses used to support the recommended use of the age-adjustment factor are available at the same website. A limited number of paper copies and CD-ROM copies will be available from: EPA's National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone: 1 (800) 490-9198 or (513) 489-8190; facsimile: (513) 489-8695. Please provide your name, your mailing address, the title and the EPA number of the requested publication (EPA/630/R-03-003F).
CONTACT: Linda C. Tuxen, National Center for Environmental Assessment (8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC, 20460; Tel: (202) 564-3332; Email: risk.forum@epa.gov
