Human Chemical is officially the first AI agent to partner with the FDA on chemical safety.
We are very excited to announce our Research Collaboration Agreement (RCA) with the FDA Human Foods Program. Under this RCA, Human Chemical and FDA are collaborating to refine and validate our AI platform’s implementation of the FDA’s Expanded Decision Tree (EDT), along with Human Chemical’s broader agentic AI system.
A significant update to the original Cramer Decision tree, the EDT is the tool that FDA uses to predict the chronic oral toxic potential of chemicals and derive safe intake levels using the Threshold of Toxicological Concern (TTC) approach.
This RCA will also aim to validate and improve Human Chemical’s AI platform, in order to assist the Human Foods Program in pre- and post-market safety evaluation of food additives, food contact substances, GRAS substances, and other substances. As part of this collaboration, FDA scientists and Human Chemical will explore the integration of non-proprietary data from FDA’s Food Additives Knowledge Base into the Human Chemical platform.
During the term of the RCA, all functions of our platform are available to FDA scientists for evaluation in regulatory and research contexts.
Together, FDA and Human Chemical will publish the results of our research in peer-reviewed, open-access manuscripts.
Our goal is to build agentic AI for decision support among regulators and industry alike. Human Chemical’s agents can screen and prioritize chemicals, identify data gaps, predict toxicological endpoints, and support weight-of-evidence evaluation.
This is a meaningful step for the modernization of toxicology and for the broader adoption of AI in chemical safety. More to come.
