Fact Sheet: Release Of EPA’s Draft Final Cancer Guidelines And Associated Draft Supplemental Guidance For Public Review And Comment


EPA
March 3, 2003
FACT SHEET: RELEASE OF EPA'S DRAFT
FINAL CANCER GUIDELINES AND ASSOCIATED
DRAFT SUPPLEMENTAL GUIDANCE FOR PUBLIC
REVIEW AND COMMENT
United States
Environmental Protection
Agency
ACTIONS: The U.S. Environmental Protection Agency (EPA or Agency) has completed a draft final
document entitled, "Guidelines for Carcinogen Risk Assessment," along with an associated draft document
entitled "Supplemental Guidance for Assessing Cancer Susceptibility from Early-Life Exposure to
Carcinogens." EPA is soliciting comments from the public on these 2003 drafts during a 60-day comment
period. A Federal Register notice, published March 3, 2003, announced: 1) the public availability of the
draft final document and the start of the comment period; 2) specific issue areas on which EPA would like
the public to focus; and 3) the availability of the draft supplemental guidance document for public review and
comment. The Federal Register notice also included information on how and where to submit comments.
SUMMARY: EPA publishes, and periodically updates/revises, a series of guidelines whose purpose is to
assist risk assessors both within EPA and outside in evaluating the risks of environmental hazards. The
guidelines were developed to promote high technical quality and Agency-wide consistency in the human
health risk assessment process. One of these documents specifically addresses the assessment of cancer
risks. EPA is nearing completion of its revision of the 1986 Guidelines for Carcinogen Risk Assessment.
The Agency began the revision of the 1986 guidelines in light of significant scientific advances in our
understanding of the processes of carcinogenesis and the modes of actions of disease at the cellular level.
The revision of these guidelines is in keeping with the Agency's original intent when it issued the first risk
assessment guidelines in 1986. The guidelines were meant to be dynamic, flexible documents that would
evolve to reflect the current state of the science and risk assessment practices.
EPA has issued a Federal Register notice announcing the public availability of the 2003 draft final
Guidelines for Carcinogen Risk Assessment and the start of a 60-day public comment period. 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. These science issues include: the nature and use of default
options; definition and application of hazard descriptors; identification of carcinogenic mode(s) of action; and
the default low-dose extrapolation approach for non-linear carcinogens. After receipt of public comments,
the Agency will address those comments in its final revised Guidelines for Carcinogen Risk Assessment.
In addition, the Federal Register notice requests public comment on a draft supplemental guidance document
entitled, "Supplemental Guidance for Assessing Cancer Susceptibility from Early-Life Exposure to
Carcinogens." This draft supplemental guidance will be reviewed by EPA's Science Advisory Board. The
draft document focuses on assessing the effects of early life stage exposure and includes a review of existing
scientific literature on chemical effects in animals and humans, as well as human exposure to ionizing radiation.
Because the areas of carcinogenicity, genesis of disease, and effects on susceptible life stages and populations
are constantly and quickly evolving, the EPA expects that this will be the first of several supplemental
guidance documents to the Guidelines for Carcinogen Risk Assessment. These companion documents will

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provide additional information on how to address specific aspects of cancer risk assessment. To enhance
Agency's understanding of age-related cancer susceptibility, EPA's Office of Research and Development is
expanding its research through an initiative that focuses on exploring appropriate measures of dose, response
characteristics, and exposure variables that may be affected by age. This research will be done through a
combination of studies in EPA laboratories, the Agency's Science to Achieve Results (STAR) grants
program, and collaborations with other federal agencies.
BACKGROUND: On September 24, 1986, EPA issued risk assessment guidelines relating to five areas:
carcinogenicity, mutagenicity, chemical mixtures, developmental toxicants, and estimating exposures
(http://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 rhttp://www.epa.gov/iri s/). Other assessments are maintained separately within individual
EPA programs (e.g., certain pesticides). Information contained in IRIS and the other assessments is used
to support Agency decisions.
DOCUMENT AVAILABILITY:
Draft Final Guidelines for Carcinogen Risk Assessment: The primary method for document availability
is via the Internet at http://www.epa.gov/ncea/raf/cancer2003.htm. A limited number of paper copies are
available from: Technical Information Staff (8623D), U.S. Environmental Protection Agency , Office of
Research and Development, National Center for Environmental Assessment, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; Telephone: 202-564-3261; Facsimile: 202-565-0050; Email:
nceadc.comment@epa.gov.
Draft Supplemental Guidance Document: The primary method for document availability is via the
Internet at http://epa.gov/ncea/raf/cancer2003.htm. A limited number of paper copies are available from:
Technical Information Staff (8623D), U.S. Environmental Protection Agency , Office of Research and
Development, National Center for Environmental Assessment, 1200 Pennsylvania Avenue NW, Washington,
DC 20460; Telephone: 202-564-3261; Facsimile: 202-565-0050; Email: nceadc.comment@epa.gov.
CONTACT: Linda C. Tuxen, National Center for Environmental Assessment (8601D), Office of Research
and Development, U.S. Environmental Protection Agency, Washington, DC; Tel: 202-564-3332; Email:
risk.forum@epa.gov

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