Draft Final Guidelines for Carcinogen Risk Assessment (External Review Draft, February 2003)
Note: EPA has updated this document, but this version is provided as a courtesy to the public as a matter of public record.
Federal Register Notices
Contact
- Technical Information Staff
- by phone at: 703-347-8561
- by fax at: 703-347-8691
- by email at: nceadc.comment@epa.gov
- by fax at: 703-347-8691
Notice
On March 29, 2005 EPA issued final Guidelines for Carcinogen Risk Assessment, along with an associated document entitled Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. Both documents are available at www.epa.gov/cancerguidelines.
The related draft document entitled Supplemental Guidance for Assessing Cancer Susceptibility Resulting from Early-Life Exposure to Carcinogens is also available online.
Prior Revisions: As part of the revisions process, the Agency published Proposed Guidelines for Carcinogen Risk Assessment in 1996 (61 FR 17960, Apr. 23, 1996). The draft revisions have been subject to extensive public comment and scientific peer review, including three reviews by EPA's Science Advisory Board. In 2001, EPA published a notice (66 FR 59593, Nov. 29, 2001) providing an additional opportunity for public comment on a 1999 draft of the Guidelines. Comments were invited on experience gained in applying previous draft revised Guidelines and on specific issues raised in previous comments by the SAB and the public.
2003 Draft Final Guidelines: As announced in the Federal Register on March 3, 2003, the Draft Final Guidelines for Carcinogen Risk Assessment are being made available for public comment. A subsequent Federal Register Notice published April 14, 2003 extended the public comment period to June 2, 2003. EPA's guiding principle for revisions is that Agency cancer risk assessments be both public health protective and scientifically sound. In particular, the revisions to the Guidelines are intended to make greater use of the increasing scientific understanding of the mechanisms that underlie the carcinogenic process. EPA is especially interested in public comments on the following areas: 1) use of default options; 2) hazard descriptors; 3) mode of action; 4) extrapolation to lower doses; and 5) susceptible populations and lifestages. At the same time, EPA is making available for public comment draft Supplemental Guidance describing possible approaches that could be used to assess risks resulting from early life exposure to potential carcinogens.
Downloads/Related Links
This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.
- Summary of the 2003 Draft Final Guidelines for Carcinogen Risk Assessment (PDF) (NA pp, 200 KB, about PDF)
- Questions and Answers About the 2003 Draft Final Guidelines for Carcinogen Risk Assessment (PDF) (NA pp, 273 KB, about PDF)
- Draft Final Guidelines for Carcinogen Risk Assessment (PDF) (NA pp, 738 KB, about PDF)
- Fact Sheet: Release of EPA's Draft Final Cancer Guidelines and Associated Draft Supplemental Guidance for Public Review and Comment (PDF) (NA pp, 125 KB, about PDF)
Related Link(s)
Additional Information
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