The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety screening in food. Announced on July 30, 2025, the EDT offers a systematic way to evaluate the structure and potential toxicity of substances found in food and food contact materials. 

This new tool may help identify which substances need further review and guide the level of additional testing required. While not a regulatory mandate, it’s a development worth noting if you’re working with food ingredients or materials that haven’t been widely evaluated. 

Keep reading to learn what the EDT is, why it matters, and how it could affect your food compliance planning. 

What is the FDA’s Expanded Decision Tree (EDT)? 

The Expanded Decision Tree is a chemical screening and risk assessment tool developed by the U.S. Food and Drug Administration. It helps evaluate the potential toxicity of food-related chemicals based on their molecular structure and available data. 

The EDT is a modernized version of the widely known Cramer Decision Tree. While the original tool used structure-based questions to estimate toxicity, the EDT refines and expands this methodology, allowing for classification with greater specificity.  

According to the FDA, the EDT can help inform the type and extent of testing or further evaluation needed, particularly where data gaps exist. 

Why is this relevant for your business? 

As expectations around food chemical safety continue to evolve, companies are looking for more reliable and cost-effective ways to assess risk. The EDT may support that goal by: 

• Streamlining early-stage toxicity screening 
• Helping identify chemicals that may warrant further review 
• Contributing to more data-informed food safety strategies 

The FDA has indicated that the EDT may be used in both pre-market and post-market evaluations of chemicals in food.  

Although this tool is not currently required by regulation, gaining a clear understanding of how it works could help businesses better anticipate areas of regulatory focus. 

Moreover, for manufacturers and suppliers using newer or less familiar substances, developing even a basic awareness of how the EDT functions can contribute to a stronger, more informed compliance strategy. 

Part of a larger modernization effort 

The EDT is part of a group of tools known as New Approach Methods (NAMs), which aim to improve how chemical safety is assessed. These approaches use large data sets and structured logic to support more efficient evaluations. 

The FDA submitted the EDT for external peer-review in March 2024, in alignment with the Information Quality Act. Based on that review, the tool was updated and has now been shared publicly for scientific and technical feedback. A software version is in development to make the tool broadly accessible.  

The FDA has also announced plans to release an informational video and host listening sessions for stakeholder input. 

What does this mean for your food compliance strategy? 

If you’re working with food or food contact substances that haven’t been widely evaluated, it’s worth noting that tools like the EDT could eventually influence how agencies assess chemical risk. Although the EDT is not a final approval mechanism, it may assist in screening and prioritizing substances for further review. 

To navigate these developments more confidently, working with regulatory consultants can help you: 

• Better understand the potential risk level of substances in your products 
• Determine whether additional testing might be necessary 
• Keep up with how FDA tools and frameworks are evolving over time 

With insights into emerging tools like the EDT, our team at Quality Smart Solutions is here to help guide your compliance strategy.