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ICCVAM Biennial Report 2018-2019

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

Rethinking Carcinogencity Assessment for Agrochemicals Project

Rodent cancer bioassays are currently required by regulatory authorities for the carcinogenicity assessment of industrial chemicals, agrochemicals, food additives, pharmaceuticals, and environmental pollutants. These studies are expensive and time-consuming and use large numbers of animals. The relevance of these studies to human biology has also been questioned. For this reason, there is increased interest in mechanistic approaches for carcinogenicity assessment that reduce testing on animals and provide information more relevant to protecting human health.

EPA is partnering with agrochemical industry stakeholders, the University of South Florida, and the PETA International Science Consortium Ltd. in the Rethinking Carcinogenicity Assessment for Agrochemicals Project. This project is exploring how requirements for rodent cancer bioassays might be replaced with a weight-of-evidence approach that would consider criteria based on potential triggers and indicators of carcinogenesis. In this project, case studies will be reviewed to determine whether the cancer risk indicated in bioassay results could have been predicted by weight-of-evidence criteria. The goal of the project is to produce a guidance document that will describe a weight-of-evidence framework for carcinogenicity assessment. The project will be described in a Society of Toxicology webinar to be presented in early 2020 and in two abstracts (Papieni; Hilton et al.) accepted for presentation at the Society of Toxicology 2020 annual meeting.