Navigating FDA Food Traceability Rules

With growing consumer demand for food transparency, the FDA has introduced new traceability regulations to ensure food safety across supply chains that will go into effect in 2026.  In a recent webinar featuring Food Safety expert Erik Kurdelak, we provided a comprehensive look at what food industry stakeholders need to know and implement under the FDA's Food Traceability Rule (FTR). 

Why Traceability Matters 

The Food Traceability Rule mandates specific traceability records for certain high-risk foods. These include soft cheeses, seafood, and certain produce. For food manufacturers, compliance involves managing detailed records across every stage of production and distribution. 

Understanding Critical Tracking Events and Key Data Elements  

During the session, Erik covered many key definitions within the rule. The two biggest definitions to understand are Critical Tracking Events and Key Data Elements.   

1. Critical Tracking Events (CTEs) are the major stages in a product's journey through your facility, such as receiving, holding, transforming, and shipping. Each event marks a point where traceability data must be captured. 
   
   
2. Key Data Elements (KDEs) are the specific data points collected at each CTE, such as the date of the event, product description, and location details and several others. 

Together, CTEs and KDEs create a chain of data that traces the product's journey, enabling faster recalls and better risk management in the case of contamination. 

Developing a Traceability Plan 

If you process any foods on the Food Traceability List, you must have a plan you can share with the FDA, and they will ask for it as part of the audit process. 

During the session, Erik outlined the five key points that each plan needs to capture: 

1. A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records. 
2. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold. 
3. A description of how you assign traceability lot codes to foods on the Food Traceability List. 
4. A statement identifying a point of contact for questions regarding your traceability plan and records. 
5. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
   

Implementation and Compliance Challenges 

Implementing and executing will involve three critical focus points:  

1. How are you going to track everything?   

Regardless of what route you take (paper or electronic data capture), the end result must be a sortable spreadsheet you can provide the FDA within 24 hours.   

1. Who is going to track everything? 
   
   Will you have a dedicated team who tracks this?  Or will you take an interdepartmental approach where your existing teams will add this to their standard operating procedures?
    
2. How are you going to train your team to remain compliant? Your training needs to incorporate several key elements: 

• • It must be part of your food safety training program.  Auditors will ask your employees “why” food traceability processes are in place, and they must be able to convey the answer. 

• • Detailed training specific to your unique processes. Every plant is different, so no one plan will work for every facility.   

Looking Ahead: What does it mean, and what do you need to do? 

With the FDA requiring 24-turnaround on all food traceability records, every organization must ask themselves, will all records need 24-hour turnaround?  Will other governing bodies begin implementing similar requirements?  Are paper and manual spreadsheets scalable?   

Food manufacturers have 15 months to prepare for full FTR compliance. In those next 15 months you need to: 

• Understand the requirements
• Asses your options to execute 
• Build your plan 
• Train your plan 
• Implement your plan 

For more insights, listen to the entire session from Erik. It’s 37 minutes that can give you and your team a strong head start and make this complex process much easier to digest.   

About Erik Kurdelak

Erik has devoted over 25 years to learning, applying, teaching, and consulting on the principles of food science. He regularly develops and provides technical training at food industry events and has done extensive work with Purdue University Food Science. In addition to serving as the State of Indiana’s Subject Matter Expert for Food Protection Division | Special Processes, Erik is also a Founding Board Member of The Central Indiana Food Hub & Sustainability Center, an Indiana Non-profit Organization in early stages of development.

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