FDA Announces Actions to Advance Implementation of Food Traceability Rule

Yesterday, FDA announced several actions related to its Food Traceability Rule, including the issuance of a draft questions and answers guidance on the rule, the finalization of an exemption for certain cottage cheese products, and the initiation of Congressionally-mandated quarterly “stakeholder engagement sessions” on the rule. These actions provide helpful insight into how FDA plans to implement the traceability rule while also offering additional opportunities to engage with FDA on key implementation challenges.

I. Questions & Answers (Q&A) Draft Guidance

FDA’s much-anticipated draft Q&A guidance addresses commonly asked questions related to various aspects of the traceability rule, including the rule’s application to specific types of entities (e.g., farms, fishing vessels, retail food establishments and restaurants), specific products (e.g., raw molluscan shellfish and commingled raw agricultural commodities), and specific activities (e.g., intracompany shipments, the breaking of pallets, and continuous processing operations). Some key insights offered by the draft guidance include the following:

• Transformation Events: The draft guidance clarifies that certain common activities are not, by themselves, “transformation” events that trigger the rule’s transformation key data element (KDE) recordkeeping requirements. For example, the guidance notes that merely “breaking” a pallet (i.e., “taking apart a pallet of food products so that individual boxes, containers, or cases can be sent to different places”) or culling produce to remove undesirable items (without otherwise repacking a lot) is not transformation. The guidance also notes that placing a sticker on a case of food to help with internal tracking at a distribution center or placing a pallet license plate on a pallet does not constitute “relabeling,” and therefore is not transformation.
• Continuous Processing Operations: The draft guidance explains that entities that conduct continuous processing operations need only maintain records for foods they handle that are on the Food Traceability List (FTL foods) at the beginning of a continuous processing event or at the end of that event.   Entities need not maintain records for FTL foods produced during intermediate steps in the processing event that are not also FTL foods by the end of the event.  For example, if a facility processes a non-FTL food (e.g. whole strawberries) into an FTL food (e.g., fresh-cut strawberries) during an intermediate processing step, but then processes that FTL food into a non-FTL finished product at the same location (e.g., frozen sliced strawberries), it would not need to maintain records under the rule for that food.
• Incomplete or Inaccurate Supplier Records: Consistent with past FDA statements, the draft guidance notes that the traceability rule does not provide a “safe harbor” for entities who receive incomplete or inaccurate KDE records from their suppliers and asserts that, in such cases, the receiving entity must still maintain the required receiving KDE records. The draft guidance does, however, note that, in practice, FDA “routinely allow[s] firms an opportunity to make voluntary corrective actions, which could include working to correct data inaccuracy, including working with the source of inaccurate or incomplete data.” The guidance also notes that when FDA finds that an entity’s traceability records are incomplete or inaccurate, it will “consider the public health impact and any voluntary corrective action by the firm” when deciding whether to take regulatory action. Thus, while FDA will expect receiving entities to maintain complete and accurate KDE records, it appears that the agency could provide some flexibility for entities to work with their suppliers to correct certain data deficiencies.
• Definition of “Fresh-Cut” Produce: The draft guidance states that, for purposes of the FTL, “fresh-cut produce” means “any fresh fruit or vegetable (or combination thereof) that has been physically altered to no longer be in its whole state (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching, freezing, cooking, canning, or packing in a juice, syrup, or dressing), with or without a wash or other treatment before being distributed in fresh form.”  FDA notes that this definition is similar, but not identical, to the definition included in its 2018 draft guidance on minimizing food safety hazards for fresh-cut produce, but that it currently plans to adopt this new “fresh-cut produce” definition in the final version of that guidance.

FDA has asked stakeholders to submit comments on the draft guidance by May 21, 2026.

II. New Exemption for Cottage Cheese

FDA announced that it is exempting Grade “A” cottage cheese products that appear on the Interstate Milk Shippers (IMS) List from the traceability rule. Cottage cheese falls within the FTL’s “cheese (made from pasteurized milk), fresh soft or soft unripened” commodity group, and is thus generally subject to the rule. FDA has concluded, however, that IMS listed Grade “A” cottage cheese products do not present the same risks as other products in this commodity group, since they are subject to specific processing requirements under the Pasteurized Milk Ordinance (PMO). Entities that manufacture, process, pack, or hold IMS listed Grade “A” cottage cheese will therefore not be required to maintain records under the rule for those products.

Notably, this marks the first time FDA has issued an exemption under the provisions of the traceability rule that allow FDA to modify the rule’s requirements or issue exemptions upon determining that application of those requirements to specific foods or types of entities is not necessary to protect the public health. This, in turn, could serve as a helpful benchmark for those seeking future exemptions.

III. Stakeholder Engagement Sessions

Starting on March 6, 2026, FDA will begin holding a series of quarterly stakeholder meetings designed to help FDA “better understand concerns and explore options for assisting regulated entities with complying with the Food Traceability Rule,” including with regard to the rule’s lot-level tracking requirements. The Partnership for Food Traceability (PFT) will organize these meetings (which FDA has characterized as “listening sessions”), and the first meeting will be open only to PFT members, with subsequent meetings open to the public.  FDA is hosting these meetings in response to a recent Congressional mandate.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.