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Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens

Risk Assessment Forum
Federal Register Notices

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, 2MB, 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, 122KB, About PDF) which provide additional information on the topic. This site includes the summary response to comments on the Supplemental Guidance (PDF) (20 pp, 117Kb, 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.


Next Steps

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).

Downloads/Related Links

Related Link(s)


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.

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