Written by: Sharon MaylMatthew Piscitelli
On November 15, FDA issued the long-awaited Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule or final rule), which establishes additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods.
More specifically, the final rule identifies Key Activities or Critical Tracking Events (CTEs) along the supply chain where records containing Key Data Elements (KDEs) will have to be created and maintained for foods on the Food Traceability List (FTL). While the final rule is limited in scope by statute, it sets the stage for the agency’s ultimate vision of end-to-end traceability across the food supply.
Here is what Israeli companies that are involved in the US food industry need to know.
Food Traceability List
After receiving public comment on an approach for developing a list of high-risk foods and the proposed FTL, FDA has now issued the final list, which includes:
- All fresh-cut fruits and vegetables
- Certain other fresh produce: leafy greens, cucumbers, peppers, tomatoes, tropical tree fruits, sprouts, herbs, melons
- Certain fresh and frozen finfish
- Fresh and frozen smoked finfish
- Fresh and frozen crustaceans
- Fresh and frozen molluscan shellfish, bivalves
- Certain cheeses
- Shell eggs
- Nut butters
- Ready-to-eat deli salads
Critical Tracking Events (CTEs)
The final rule identifies key activities along the supply chain for which KDEs must be created and maintained. These include:
- Harvesting: Removing raw agricultural commodities (RACs) from the place they are grown or raised and preparing them for use as food.
- Cooling (before initial packaging): Active temperature reduction of RACs using hydrocooling, icing, forced air cooling, vacuum cooling or a similar process.
- Initial packing of RACs other than food obtained from a fishing vessel: Packing a RAC for the first time.
- First land-based receiving of food obtained from a fishing vessel: Taking possession of a food for the first time on land directly from a fishing vessel.
- Shipping: Event in the food’s supply chain in which a food is arranged for transport from a defined location to another defined location at a different farm or receiver. Shipping includes sending an intracompany shipment of food from one location of a firm to another location of the same firm. Shipping does not include the sale or shipment of a food directly to a consumer.
- Receiving: Event in which a customer (other than a consumer) receives a food on the FTL at a defined location after being transported from another location. Receiving includes receipt of an intracompany shipment of food from one location of a firm to another location of the firm.
- Transforming: Event in the food’s supply chain that involves manufacturing/processing or changing a food (eg, by commingling, repacking or relabeling), or its packaging or packing, when the output is a food on the FTL. Transformation does not include the initial packing of a food or activities preceding that event (eg, harvesting, cooling). Note that transforming includes those activities previously included in the proposed CTE of “creating” because FDA determined the categories were too similar to warrant separation.
Key Data Elements (KDEs)
The rule also identifies the KDEs associated with a CTE for which a record must be established and maintained. The KDEs will vary at each CTE, but the records will contain information necessary to effectively trace back a product based on the CTEs a firm performs. The KDEs will allow a food to be traced along the supply chain, which will assist regulators and industry in the case of a food safety event.
In addition to requiring records of KDEs, the final rule also requires anyone subject to the rule to establish and maintain a traceability plan. The plan must contain descriptions of how a firm maintains traceability program records (including relevant reference records for the KDEs), lists of food on the FTL that are shipped, a description of how traceability lot codes are assigned, a statement identifying a point of contact regarding traceability plans and records, and other information needed to understand data provided within the required records. The traceability plan requirements also include farm maps showing locations and names of fields (or containers for aquaculture farms) where food on the FTL is grown, including geographic coordinates and other location information.
The final rule does not require that records be kept electronically or to communicate electronically, other than to provide an electronic, sortable spreadsheet with relevant tracing information when FDA is investigating an outbreak, recall or other threat to public health. Nevertheless, the agency encourages all those subject to the Food Traceability Rule to incorporate electronic recordkeeping and communication procedures into their traceability programs to facilitate and expedite the analysis of data and completion of traceback and traceforward operations.
Compliance dates and exemptions
The final rule specifies that all persons subject to these recordkeeping requirements must comply by January 20, 2026. While the proposed rule staggered compliance dates based on firm size, the agency chose a single date because of the need for all entities subject to the final rule to share information in order to achieve effective and efficient traceability. To accommodate this change, the agency is allowing three years from the effective date of the final rule, which is a year longer than the proposed compliance date.
The final rule exempts certain small producers (including small produce farms, shell egg producers, and other producers of RACs) and, at the other end of the supply chain, certain small retail food establishments and restaurants. FDA published a tool to help stakeholders determine if the final rule applies to their operations.
The future of traceability
The final Food Traceability Rule represents the first step toward FDA’s larger goal end-to-end traceability throughout the supply chain. Through FDA’s New Era of Smarter Food Safety initiative, FDA is encouraging firms to voluntarily adopt the foundational components of the Food Traceability Rule to achieve end-to-end traceability throughout the food system. FDA will be working with the food and technology industries to create financial models that will enable human and animal food firms of all sizes to participate in a scalable, cost-effective way, focusing not on any particular technology but rather on interoperability across a variety of technology solutions.
Please contact the authors of this alert or your usual DLA Piper attorney with any questions.