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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Waiver Criteria for Carcinogenesis Testing

For the past 40 years, questions have been raised about the relevance and regulatory utility of rodent cancer bioassays in human health risk assessment. To address these questions, EPA collaborated with experts from industry and animal welfare stakeholder groups to form the Rethinking Carcinogenicity Assessment for Agrochemicals Project. The project’s goal is to determine both the appropriateness of and criteria for waiving rodent cancer bioassays for the registration of food-use pesticides. A weight-of-evidence reporting framework is being developed to determine when sufficient information is available to perform a health-protective chronic risk assessment without conducting rodent cancer bioassays. Information used includes exposure, mode-of-action, physiochemical properties, metabolism, and subchronic toxicological data from standard risk assessment endpoints. An abstract describing the framework criteria and example carcinogenicity waivers (Hilton et al.) was accepted for presentation at the 2020 Society of Toxicology meeting.