The US Food and Drug Administration (FDA) has released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool, advancing the agency’s commitment to transparency and enhancing its food chemical safety programme.
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.
The FDA helps to safeguard the food supply by evaluating the safe use of chemicals as food ingredients and food contact substances.
To achieve this, the FDA employs scientific and regulatory tools to evaluate the safety of chemicals in food, 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 modernised version of the original Cramer Decision Tree tool 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 prioritisation of chemicals for post-market review.