Today, the U.S. Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool that advances the agency’s commitment to transparency and enhancement of the food chemical safety program. 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 was evaluated through external peer-review, marking a significant milestone in its development. The agency will engage stakeholders and the public for further feedback on the tool.
Some chemicals have toxic properties that may pose a risk to human health when we are exposed to them at certain levels. The FDA helps to safeguard the food supply by evaluating the safe use of chemicals as food ingredients and food contact substances. To do this, the FDA uses scientific and regulatory tools to assess the safety of chemicals in food while continually updating these methods to incorporate new approaches.
The EDT is one example of New Approach Methods, which leverage large data sets to achieve faster and less expensive informative new approaches to chemical assessments that can inform risk management decisions and actions. The EDT has gained widespread international support in recent years. This approach to evaluating the safety of chemicals is a modernized version of the original Cramer Decision Tree toolExternal Link Disclaimer and can be used to screen chemicals based on their structural features. The Cramer Decision Tree tool, which is a scientific tool that sorts chemicals into classes of chronic toxic potential using a series of mainly chemical structure-based questions, has been widely used by scientists to provide a quick, preliminary estimate of a new chemical’s predicted toxicity, especially when the testing data about a chemical is limited. The updated, expanded, and greatly refined set of fully chemical structure-based questions in the FDA’s EDT allows classification of chemicals with greater specificity than the Cramer Decision Tree. The EDT will also help inform the nature and extent of additional testing or evaluation that may be needed to help address potential data gaps for chemicals in food. The EDT is expected to eventually be used in both pre- and post-market evaluation of chemicals in food to help ensure the food supply remains safe. The FDA anticipates that the EDT will provide information that can be incorporated into the agency’s prioritization of chemicals for post-market review.
In March 2024, the FDA submitted the EDT for external peer-review. This review collected input from external scientific experts in line with the requirements of the Information Quality Act. The FDA updated the EDT based on the review and is now publicly releasing it to the scientific community for technical consideration. Meanwhile, the FDA is developing a software solution for the EDT for general public use and will further refine the EDT over time with access to more information about chemicals in the food supply and based on public input.
The FDA will release an informational video to explain the EDT and will hold listening sessions to receive input from interested parties. More details will follow.