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

Risk Assessment Forum

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 Guidelines for Carcinogen Risk Assessment (2005).

EPA published its first cancer risk guidelines in 1986 (Guidelines for Carcinogen Risk Assessment (PDF)[51 FR 33992, Sept. 24, 1986]) (38 pp, 163KB, about PDF). 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 (PDF) (425 pp, 163KB, about PDF) 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 (PDF) (54 pp, 112KB, about PDF) (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 (PDF) (3 pp, 30KB, about PDF) of the 1996 Proposed Guidelines
Review of Revised Sections of the Proposed Guidelines for Carcinogen Risk Assessment (PDF) (53 pp, 283KB, about PDF) (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 (PDF) (61 pp, 172KB, about PDF) (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 (PDF) (19 pp, 64KB, about PDF) (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 (PDF) (4 pp, 52KB, about PDF) (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 (PDF) (49 pp, 181KB, about PDF) (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 (See Federal Register (PDF) / Vol. 66, No. 230 / Thursday, November 29, 2001 / Notices) for further information.

Contact: Risk Assessment Forum Staff, 202-564-6483, or risk.forum@epa.gov

Downloads/Related Links

Draft Revised Guidelines for Carcinogen Risk Assessment (External Review Draft, July 1999) (PDF) (211 pp, 1MB, about PDF)
An Sab Report: Guidelines for Cancer Risk Assessment (PDF) (54 pp, 111KB, about PDF)

Citation

Draft Revised Guidelines for Carcinogen Risk Assessment (External Draft, July 1999). U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 1999.