FDA Takes Several Actions Related to the Food Traceability Rule

Constituent Update

February 19, 2026

The U.S. Food and Drug Administration today issued guidance addressing stakeholder questions regarding implementation of the Food Traceability Rule and a notice exempting certain cottage cheese products from the requirements of the Food Traceability Rule. FDA is also announcing a series of engagements with stakeholders to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA is committed to ensuring industry has the information and tools necessary to comply with the Food Traceability Rule and these actions advance that objective.

The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List. The final rule requires such entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help FDA rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

Questions and Answers Guidance on the Food Traceability Rule

The guidance issued today includes questions and answers to assist industry with understanding the scope of the Food Traceability Rule and meeting the requirements of the rule. The guidance addresses several topics, including:

Applicability of the rule to entities such as farms, farmers’ market stalls, fishing vessels, first land-based receivers, retail food establishments, and restaurants;
Applicability of the rule to activities such as intracompany shipments, commingling, initial packing, and transformation, including answers to questions about breaking pallets and culling produce;
Details about the exemption for raw molluscan shellfish;
Determining if a product is “fresh-cut” for the purpose of identifying whether it is on the Food Traceability List; and
Additional information on the food traceability plan and recordkeeping requirements.

Guidance documents represent FDA’s current thinking on a specific topic. Guidance documents do not impose legally enforceable requirements. Public comments on this guidance document can be submitted to https://www.regulations.gov/, using Docket FDA-2025-D-2837.

Finalizing Exemption for Certain Cottage Cheese Products from the Requirements of the Food Traceability Rule

In the preamble to the final Food Traceability Rule, FDA announced its intention to consider initiating a process to exempt certain cottage cheese products from the rule. In 2024, FDA published a notice proposing to exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers (IMS) List (“IMS listed Grade “A” cottage cheese”) from the rule. Today, FDA is publishing a notice announcing that we are finalizing that exemption.

Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS). FDA and NCIMS have together developed a cooperative, Federal-State program (the IMS Program) to ensure the sanitary quality of milk and milk products shipped interstate. The IMS program relies on the Pasteurized Milk Ordinance (PMO), which represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese. After considering the comments on the proposal, FDA has concluded that the exemption is warranted because the processing requirements specified in the PMO for IMS listed Grade “A” cottage cheese address the risk factors that resulted in cottage cheese being included on the Food Traceability List, and because of the enhanced oversight of the manufacturing of IMS listed Grade “A” cottage cheese through the IMS program. In keeping with the statutory and regulatory provisions that allow for this type of exemption, facilities required to register with FDA that manufacture, process, pack, or hold IMS listed Grade “A” cottage cheese will still be required to maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food.

Stakeholder Engagement Sessions

The FDA is also announcing a series of engagements with stakeholders, organized by the Partnership for Food Traceability (PFT), to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA will engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to better understand concerns and explore options for assisting regulated entities with complying with the Food Traceability Rule. The PFT and FDA will hold a series of listening sessions on these topics. The sessions will include opportunities for public input as well as smaller group discussions. The listening sessions will provide an opportunity to engage with FDA on Food Traceability Rule implementation of lot-level tracking, challenges facing regulated entities, and potential solutions. The first session will take place March 6, 2026, for PFT members, with a public session the following quarter. Additional sessions will be announced as they are scheduled.

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