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Proposed Guidelines for Carcinogen Risk Assessment

Risk Assessment Forum

The Proposed Guidelines for Carcinogen Risk Assessment were published in the Federal Register on April 23, 1996 (Federal Register: 17960-18011) for a 120-day public review and comment period. The Proposed Guidelines are a revision of EPA's 1986 Guidelines for Carcinogen Risk Assessment (51 FR 33992), and when final, will replace the 1986 cancer guidelines. The full text of the FR notice also is being made available via the Internet.

Since the publication of the 1986 cancer guidelines, there is a better understanding of the variety of ways in which carcinogens can operate. Today, many laboratories are moving toward adding new test protocols in their programs directed at mode of action questions. Therefore, the Proposed Guidelines provide an analytical framework that allows for the incorporation of all relevant biological information, recognize a variety of situations regarding cancer hazard, and are flexible enough to allow for consideration of future scientific advances.

The 1986 cancer guidelines have several limitations in addition to their inadequacy in addressing recent gains in the understanding of carcinogenesis. Although they called for the evaluation of all relevant information, the classification scheme used for identifying potential human hazard relied heavily on tumor findings, and in practice, seldom made full use of all biological information. Moreover, the conditions of the hazard were not taken into account. For example, it was common to assume that if an agent was carcinogenic by one route of exposure (e.g., inhalation), it posed a risk by any route. The 1986 cancer guidelines are also confined in that dose-response assessment allowed for only one default approach (i.e., the linearized multistage model for extrapolating risk from upper-bound confidence intervals). Moreover, very little guidance was given for risk characterization, the component of risk assessment that describes potential human risk, strengths and weaknesses of data, size of risk, and confidence of the conclusions for the risk manager. The Proposed Guidelines include the following changes to address these limitations, accommodate new information on carcinogenesis, and advance cancer risk assessment:

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

Downloads/Related Links


U.S. EPA. Proposed Guidelines for Carcinogen Risk Assessment. U.S. Environmental Protection Agency, Office of Research and Development, National Center For Environmental Assessment, Research Triangle Park Office, Research Triangle Park, NC.

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