The U.S. Food and Drug Administration (FDA) has made new announcements regarding the Food Traceability Rule, which fulfills Section 204(d) of the Food Safety Modernization Act (FSMA 204).

Specifically, FDA issued guidance addressing stakeholder questions regarding implementation of the rule and a notice exempting certain cottage cheese products from FSMA 204 requirements.

FDA is also announcing a series of engagements with stakeholders to support preparedness and compliance with the Food Traceability Rule, to be announced as they are scheduled. The compliance date was recently extended to July 20, 2028.

Questions and Answers Guidance on the Food Traceability Rule  

The new guidance includes questions and answers to clarify the scope of the Food Traceability Rule and its requirements. 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
• Additional information on the food traceability plan and recordkeeping requirements.  

Public comments on the guidance document can be submitted to regulations.gov using Docket FDA-2025-D-2837.

Finalizing Exemption for Certain Cottage Cheese Products

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. FDA is now 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

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. 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 on March 6, 2026, for PFT members, with a public session the following quarter. Additional sessions will be announced as they are scheduled.