FDA Releases New Traceability Rule Guidance

The U.S. Food and Drug Administration (FDA) issued new guidance addressing stakeholder questions regarding implementation of the Food Traceability Rule and a notice exempting certain cottage cheese products from the requirements of the rule.

The agency also announced 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.

The Food Traceability Rule, also known as FSMA Section 204, establishes additional recordkeeping requirements for those who manufacture, process, pack or hold foods FDA has designated for inclusion on the Food Traceability List. Last year, the FDA extended the deadline for companies to comply with the rule, bumping it from January 2026 to July 20, 2028.

FSMA 204 will require these entities to maintain records containing information on critical tracking events in the supply chain for designated foods, such as initial packing, shipping, receiving and transforming these foods. The requirements established in the rule will help FDA more rapidly identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death, said the agency.

Q&A on the Food Traceability Rule.

The guidance issued Feb. 19 includes questions and answers to assist industry with understanding the scope of the Food Traceability Rule and meeting its requirements. The guidance addresses topics such as:  

• 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, said the agency; they do not impose legally enforceable requirements.

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

Finalizing Exemption for Certain Cottage Cheese Products.

In 2024, FDA proposed exempting Grade A cottage cheese that appears on the Interstate Milk Shippers (IMS) List from the Food Traceability Rule. The agency published a notice Feb. 19 announcing that it is 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 (IMS) to ensure the sanitary quality of milk and milk products shipped interstate, said FDA. The IMS program relies on the Pasteurized Milk Ordinance (PMO), which represents current science-based knowledge and experience concerning the safe production and processing of Grade A milk products, including cottage cheese.

After considering comments on the proposal, FDA said it 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 announced 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 series will start with a session on March 6 for PFT members. A public session will be held the following quarter, said FDA.

The sessions will include opportunities for public input and smaller group discussions, including conversations about lot-level tracking, challenges facing regulated entities and potential solutions.

Additional sessions will be announced as they are scheduled, said FDA.