Expanded Decision Tree: US FDA's Food Chemical Toxicity Screening Tool

Registration is required for this free webinar 

Hosted by the SOT Food Safety & Computational Toxicology Specialty Sections 

Scientific innovation has rapidly expanded the number and diversity of chemicals to which humans may be exposed, creating an urgent need for efficient tools to screen and prioritize substances based on their chronic toxic potential and to estimate safe exposure levels. At the same time, there is growing momentum to reduce reliance on animal testing in safety assessment. In response, the FDA developed the Expanded Decision Tree (EDT)—a chemical structure-based classification system that sorts chemicals into one of six classes of chronic oral toxic potential, each associated with a threshold of toxicological concern (TTC) level. Under this framework, exposures below the class-specific TTC can be reasonably anticipated to present minimal risk. While originally designed with food-related chemicals in mind, the EDT has broad applicability. It can support the evaluation of structurally diverse compounds across many domains, assist with prioritization and read-across for data-poor substances, and provide approaches for assessing mixtures and cumulative exposures. While focused on oral toxicity, the EDT also shows promise for inhalation and dermal applications with further development. This presentation will provide an overview of the EDT, including recent progress in external validation efforts, outcomes from peer review, and the current status of EDT software development. Potential applications of the tool will also be discussed, highlighting its potential to advance chemical safety evaluations and reduce reliance on animal testing. 

Speaker 

Szabina Stice, PhD, Senior Toxicologist, US FDA