Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens
Risk Assessment Forum
The Cancer Guidelines explicitly call for consideration of possible sensitive subpopulations and/or lifestages (such as childhood). The consideration of childhood risks in the final Cancer Guidelines has been augmented by the development of the document entitled Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens EPA/630/R-03/003F (PDF) (126 pp, 1.6 MB, About PDF). Also available from this site are the: 2005 Cancer Guidelines, External Questions and Answers, Cancer Guidelines Fact Sheet, Issuance Fact Sheet, and the Memorandum on the Application of New Cancer Guidelines (PDF) (2 pp, 114 KB, About PDF) which provide additional information on the topic. This site includes the summary response to comments on the Supplemental Guidance (PDF) (20 pp, 88 KB, About PDF) and the data and analyses used in deriving the adjustments to potency.
In 1983, the National Academy of Sciences (NAS)/National Research Council (NRC) published its report entitled Risk Assessment in the Federal Government: Managing the Process. In that report, the NRC recommended that Federal regulatory agencies establish "inference guidelines" to promote consistency and technical quality in risk assessments and to ensure that the risk assessment process was maintained as a scientific effort separate from risk management. EPA responded to this recommendation by publishing a set of risk assessment guidelines in 1986, including the Guidelines for Carcinogen Risk Assessment (51 FR 33992, September 24, 1986).
EPA began revising the 1986 cancer guidelines in light of significant advances in our understanding of the processes of carcinogenesis and the modes of actions of disease at the cellular level. Revising the cancer guidelines is in keeping with EPA's original intent when it issued the first set of final risk assessment guidelines in 1986. The risk assessment guidelines were meant to be dynamic, flexible documents that would evolve to reflect the current state of the science and risk assessment practices. In keeping with this, EPA undertook an effort to revise the cancer guidelines as described below in the History and Chronology section.
- Mar 2003 EPA released the Draft Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens for public comment. At this time, the SAB reviewed the Draft Supplemental Guidance.
- Mar 2004 EPA received SAB comments (PDF) (40 pp, 347 KB) on the Supplemental Guidance.
- 2004/05 In response to an SAB recommendation (PDF) (7 pp, 39 KB), EPA extended the analysis supporting the Supplemental Guidance. The National Institute of Environmental Health Sciences (NIEHS) journal, Environmental Health Perspectives, peer reviewed this analysis and accepted it for publication. A separate peer review of this analysis was also conducted.
- Mar 2005 EPA published the final Supplemental Guidance (PDF). (126 pp, 1.6 MB, about PDF)
The Supplemental Guidance serve as EPA's recommendation to Agency risk assessors preparing cancer risk assessments. As EPA prepares cancer assessments under the Integrated Risk Information System (IRIS) program, as well as in other EPA programs, the Agency intends to begin to use the Guidelines and Supplemental Guidance. EPA also intends to consider the Guidelines and Supplemental Guidance along with other selection factors when EPA selects agents for reassessment in annual IRIS agendas (see for example, 70 FR 10616, March 4, 2005).
- Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens (EPA/630/R-03/003f) (PDF) (126 pp, 1.6 MB, about PDF)
- Summary Response to Comments on EPA's Draft Supplemental Guidance (PDF) (20 pp, 88 KB, about PDF)
- Supplemental Guidance Implementation
- 2005 External Questions and Answers
- 2005 Fact Sheet
- Data and Analyses Used in Deriving the Adjustments to Potency Are Available on This Site
- Guidelines for Carcinogen Risk Assessment (Final)
- (Refn Article) Assessing Susceptibility from Early-Life Exposure to Carcinogens
- Presentation on the Supplemental Guidance for Assessing Cancer Risks from Early-Life Exposures (PPT) (284 KB)
- Presentation of the EPA Cancer Guidelines and Supplemental Guidance at the 2005 Toxicology and Risk Assessment Conference
- Communication I: Application of the Mode of Action Framework in Mutagenicity Determinations for Carcinogenicity (PDF) (8 pp, 651 KB, about PDF)
- Communication II: Performing Risk Assessments That Include Carcinogens Described in the Supplemental Guidance as Having a Mutagenic Mode of Action (PDF) (4 pp, 236 KB, about PDF)
The final Cancer Guidelines and Supplemental Guidance are available for use by EPA risk assessors, replacing the initial 1986 guidelines publication and the July 1999 interim guidance. Federal Register Notice (posted April 7, 2005).
U.S. EPA. Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens. U.S. Environmental Protection Agency, Washington, DC, EPA/630/R-03/003F, 2005.