FDA Releases New Tool for Toxicity Screening of Chemicals in Food

On July 30, 2025, the U.S. Food and Drug Administration (FDA) released a new chemical toxicity and risk screening tool—the Expanded Decision Tree (EDT). In an announcement about the release of the EDT, FDA explained that “the tool provides a consistent, systematic, and science-based approach to support evaluation of the safety of chemicals in food based on their structure and estimated toxicity.”

The EDT is a modernized version of the Cramer Decision Tree that allows chemicals to be screened based on their structural features, ranging from Class I (i.e., those chemicals with very low toxic potential) to Class VI (i.e., those chemicals with the highest toxic potential). Each class has a threshold of toxicological concern (TTC) level that is used when evaluating long-term, repeated oral exposure of chemicals in food. This allows classification of chemicals with greater specificity and supports the food chemical safety program, according to FDA.

The EDT underwent a validation and external peer review process by subject matter experts to evaluate the tool’s applicability, reliability, clarity, and limitations. The results of that process were included in documents finalized by the FDA in June 2025. Specifically, the Phase II document contains the final, post-validation and post-external peer review version of the EDT. FDA has now publicly released it to the scientific community for technical consideration and is developing a software version for broader use. In addition, FDA plans to release an informational video and hold listening sessions to gather stakeholder feedback—these engagements are designed to further refine the tool over time.