SOT FDA Colloquium: Redesigning the Rodent Bioassay for the 21st Century

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On February 20, 2019, SOT and US FDA hosted a colloquium featuring an ongoing dialogue between stakeholders on the utility of the chronic rodent bioassay for regulatory risk assessment.

Today, toxicological evaluation of chemicals is beginning to take advantage of the on-going revolution in biology and biotechnology. This revolution is making it increasingly possible to study the effects of chemicals using cells, cellular components, and tissues—preferably of human origin—rather than whole animals. In carrying out its mission to protect and promote public health, FDA must use the best scientific and technological information available to make decisions on the products it regulates. Regulators must assure their toxicology toolbox keeps pace with advances in science and technology. This workshop will discuss at how one important toxicology tool, the rodent chronic bioassay, should be redesigned to meet the needs of 21st century risk assessment.