What You Need to Know About the FDA Food Traceability Rule: Key Data Elements (KDEs) with Examples

The Food and Drug Administration's (FDA) final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2026.

The purpose of the FDA Traceability Rule is to enhance the traceability of high-risk foods through the supply chain. It involves better tracking from source (farms) through the supply chain until it reaches the consumer. Some smaller operators are exempt from the rule but should follow the same rules as a best practice. One key part of this rule is documenting and retaining Key Data Elements (KDEs).

What Is a Key Data Element (KDE)?

KDEs are essential pieces of information that are captured at every Critical Tracking Event (CTE). KDEs provide valuable insights into food product origin, handling, and attributes.

Who Needs to Supply Key Data Elements (KDEs)

Who needs to provide KDEs? Each entity that has possession of the food needs to retain documentation on the Key Data Elements (KDEs):

1. Where the food came from, including all the KDEs from where the food started.

2. How the food was stored and modified.

3. Where the food went.

Again, the information must be passed on to the next entity and each entity must retain the information. The FDA estimates that annually three billion records will need to be kept by the food industry.

KDEs Product Example

Melons are harvested:

1. The farmers track all appropriate KDEs and ship the melons to a wholesaler with the KDE documentation.

2. The wholesaler takes the fruit and sends it to a processor. The wholesaler adds their KDEs to the farmer’s KDEs and provides them to each business.

3. The processor chops the melons, packs them into single-serve containers, and adds their KDEs to the documentation file.

4. Some single-serve containers are shipped to a food service distributor and some to a grocery distributor, including the documentation file with all the KDEs.

5. The food service distributor delivers to college cafeterias, nursing homes, high schools, and a convenience store chain.

6. Each business must retain the KDEs for the melons and track how and when they were used and if any were destroyed due to exceeding the freshness date.

KDEs could include, but are not limited to:

• Farmer: When and where the produce was raised, inputs used to raise it, how and who harvested it, when it was cooled, how it was stored, who and when it was shipped, what temperature it was shipped, and who it was shipped to.

• Wholesaler: When the shipment arrived at the wholesaler, the arrival temperature, who unloaded it, when it arrived in the cooler, how it was handled in the cooler, what was done with it while at the wholesaler, and when it shipped and to whom.

• Processor: When it arrived, the arrival temperature, who unloaded the shipment, when it arrived in the cooler, when it was processed, what shift processed it, when the processing equipment was cleaned before processing, who cleaned the equipment, where the containers came from that the produce went into, the batch number, the freshness date, how it was stored, how long it was stored, the temperature throughout the process, the temperature at shipping, who shipped it, and when it shipped and to whom.

• Food Service Distributor: When it arrived, the arrival temperature, who unloaded the shipment, when it arrived in the cooler, the batch number, the freshness date, how it was stored, how long it was stored, the temperature throughout the process, the temperature at shipping, who was the shipper, when was it shipped, and to whom.

• Business That Served to Consumer: When it arrived, the arrival temperature, who unloaded the shipment, when it arrived in the cooler, the batch number, the freshness date, how it was stored, how long it was stored, temperature throughout the process, temperature when served, dates served, and if any were destroyed due to exceeding the freshness date.

Business Example

Fred’s Cold Salads makes and sells cold salads to food service companies. We will focus on just one of their products, potato salad. This example is designed for informative purposes only.

1. Every supplier of ingredients will provide all appropriate KDEs.

2. The potato salad uses 27 ingredients. Fred must closely follow the recipe and document the KDEs by batch. The business must track how much of each ingredient goes into each batch of salad, where the ingredients came from, and other KDEs for each ingredient.

3. Each batch/lot must have the KDE for that batch, including the batch number and freshness dates. This information must be compiled for and follow each batch.

4. Fred must document the source of the containers, how the containers were stored, and which batch has what containers and add that to the KDEs.

5. Fred must also document the temperatures at which the potato salad is stored and the temperature when loaded in shipments and add that to the KDEs.

6. Fred must track to whom the batches are sold and who was the shipper.

7. Fred must provide all KDEs to the purchaser and maintain all KDEs for at least two years.

8. The food service distributor who receives Fred’s Potato Salad must track who delivered the potato salad, at what temperature it was delivered, who unloaded it, how fast it was put in the cooler, the temperatures at which it was stored, and when and to whom it was sold. These KDEs must be added to all the other KDEs and provided to the businesses that receive the salad.

9. The potato salad is delivered to college cafeterias, nursing homes, high schools, and a convenience store chain.

10. Each business is responsible for retaining the accumulated KDEs and must track how the salad was used, when it was consumed, and when and if any was destroyed due to exceeding the freshness date.

KDEs could include, but are not limited to:

• Potatoes, onions, celery: When and where raised, inputs used to raise the produce, how and who harvested, when cooled, how stored, any processing done to the produce (washed), who was the shipper, when it was shipped, what temperature it was shipped, and who it was shipped to.

• Eggs: When and where raised, inputs used to raise the eggs, how and who harvested, when cooled, how stored, any processing (washed), who was the shipper, when it was shipped, what temperature it was shipped, and who it was shipped to.

• Mayo, vinegar, pickle relish, Dijon mustard, and other processed ingredients: Who made it, where, when, temperatures, freshness date, shipper, etc.

• Celery salt, paprika, salt, pepper, and other spices: Who made it, where, when, temperatures, freshness date, shipper, etc.

• Processor: When each ingredient arrived at the processor, what temperature was at arrival, who unloaded it, when it arrived in the cooler (or stored), how it was handled in the cooler, what was done with it while at the processor, and the freshness date for each.

• Process: When the potato salad was made, the batch control, temperature at processing, what shift processed it, when the processing equipment was last cleaned before processing, who cleaned the equipment, where the containers came from that the produce went into, the batch number, the freshness date, how it was stored, how long it was stored, the temperature throughout the process, the temperature at shipping, who was the shipper, when was it shipped, and to whom.

All these key data elements must be documented and stored for two years. If the FDA requests information, the company must provide the information within 24 hours.