Draft Revised Guidelines for Carcinogen Risk Assessment (External Draft, July 1999)

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EPA published its first cancer risk guidelines in 1986 (Guidelines for Carcinogen Risk Assessment [51 FR 33992, Sept. 24, 1986]). These Guidelines set forth principles and procedures to guide EPA scientists in assessing the cancer risks from chemicals or other agents in the environment and inform the public about these procedures. EPA continues to revise its risk assessment guidelines and to develop new guidelines as experience and scientific understanding evolve. As part of that process, the Agency published Proposed Guidelines for Carcinogen Risk Assessment in 1996 (61 FR 17960, Apr. 23, 1996). The proposed guidelines, and subsequent draft revisions to the Guidelines have been subject to extensive public comment and scientific peer review, including reviews by EPA's Science Advisory Board (SAB). EPA has also hosted scientific workshops on children's cancer risks and received input from EPA's Children's Health Protection Advisory Committee.

Supplementary Materials

In addition to the draft revised Guidelines, below are supplementary materials which mark key milestones in the development of the current draft guidelines or that will be considered as EPA completes revisions to the guidelines.These materials include:
  • An SAB Report: Guidelines for Cancer Risk Assessment (EPA-SAB-EHC-97-010, Sept 1997) The EPA Science Advisory Board's review of the 1996 proposed revisions to the cancer guidelines.
  • EPA's Response to the SAB's Review of the 1996 Proposed Guidelines
  • Review of Revised Sections of the Proposed Guidelines for Carcinogen Risk Assessment (EPA-SAB-EC-99-015, July 1999) The EPA Science Advisory Board's review of the Agency's revisions to sections of the proposed guidelines
  • Review of the EPA's Draft Revised Cancer Risk Assessment Pertaining to Children (EPA-SAB-EC-00-016, September 2000) The SAB's review of the Agency's July 1999 revisions to address the protection of children.
  • EPA's Response to the SAB January 1999 and July 1999 reviews (January 2001) EPA's consolidated response to two SAB reviews held in 1999. The SAB considered revised sections of the 1996 proposed guidelines (EPA-SAB-EC-99-015, July 1999) and later considered guideline revisions to address the protection of children (EPA-SAB-EC-00-016, September 2000).
  • EPA's Children's Health Protection Advisory Committee (CHPAC) letter (May 1999) CHPAC suggested questions for the EPA Science Advisory Board to consider in its review of revisions to the proposed guidelines.
  • Summary of the Workshop on Information Needs to Address Children's Cancer Risk (EPA/600/R-00/105, September 2000) Report from the March 2000 workshop co-sponsored by EPA on information needs to address children's cancer risk.
Interim Use of 1999 Draft Revised Guidelines

The July 1999 draft revised guidelines serve as EPA's interim guidance to EPA risk assessors preparing cancer risk assessments [Federal Register / Vol. 66, No. 230, Thursday, November 29, 2001]

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.