FSMA rules are back on FDA’s docket with a focus on traceability and produce: With compliance to the Traceability Rule having been extended to July 20, 2028, the FDA has issued guidance and is scheduling quarterly listening sessions organized by the Partnership for Food Traceability (PFT), which is led and managed by TAG and Leavitt Partners. The agency is also working with state associations to establish regulatory program standards for produce safety.
The Traceability Rule Guidance
In brief, the Food Traceability Rule (FSMA 204) establishes expanded recordkeeping requirements for those who manufacture, process, pack, or hold foods on the Food Traceability List. These entities must maintain records for any FTL foods, such as initial packing, shipping, receiving, and transforming these foods.
The traceability guidance has been published to address questions and assist industry with understanding the scope of the rule and meeting its requirements. The questions with answers focus on the rule’s Food Traceability List (FTL), Traceability Plan, Initial Packing and Transformation of an FTL Food, Commingling, and Recordkeeping, along with questions on the specific areas of Farms, Fishing Vessels, Raw Molluscan Shellfish, and Retail Food Establishments and Restaurants.
Interestingly, while the rule’s requirement for the maintenance of records on key data elements (KDEs) associated with specific critical tracking events (CTEs) is likely one of its most complex elements, there are no questions/answers that specifically address these. Beyond statements such as “At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL maintain records containing key data elements (KDEs) associated with specific CTEs” and “Under the Food Traceability Rule, each covered entity is responsible for the KDEs that relate to the CTEs they perform,” the question responses include requirements for CTEs and KDEs in particular situations, but are never explained in any further detail. On the other hand, restaurants and retail food establishments have a lot to glean from the guidance, as a full five pages is dedicated to questions related to these businesses.
Partnership for Food Traceability (PFT)
With nearly two years remaining until compliance is due, it is likely that many businesses have not yet set this as a priority, despite the rule’s complexity and the urging by groups such as PFT to continue moving forward and not wait until the 11th hour.
“While FSMA 204 is ultimately about improving outbreak response and food safety, successful compliance will almost always involve changes to operational and IT systems,” said Dr. Ben Miller, TAG COO & EVP of Regulatory and Scientific Affairs. “Operational and IT changes take significant time to develop, deploy, train, and test, and the July 2028 compliance deadline will come quickly for everyone in the supply chain.”
So, to assist the industry in moving forward, the PFT and FDA will be holding a series of quarterly listening sessions with the regulated entities, for FDA to better understand concerns and explore options for assisting in industry’s compliance with the rule. The sessions will include opportunities for public input and smaller group discussions. 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.
“PFT is having great success connecting industry with the FDA in creating a better understanding of the realities and complexities of compliance with FSMA 204,” Dr. Miller said, adding, “The race is starting now, even though the finish line feels like many miles away!”
In Other Regulation
- Cottage Cheese. FDA also published a notice finalizing the exemption of IMS-listed Grade “A” cottage cheese from the rule. The decision was made based on the fact that the product is regulated through the National Conference on Interstate Milk Shipments (NCIMS), based on the Pasteurized Milk Ordinance (PMO) which addresses the risk factors that had caused cottage cheese to be included on the Food Traceability List. These facilities are still required to maintain records identifying the immediate previous source and subsequent recipient of the food.
- Produce. In collaboration with NASDA and AFDO and state produce inspection programs, the FDA has established the Produce Regulatory Program Standards (PRPS) to provide a consistent framework for government agencies who regulate farms, produce commodities, and activities covered under the FDA’s Produce Safety Rule. The PRPS is intended to enhance capacities of produce regulatory programs, promote program consistency and workforce training, assist programs in developing risk-based inspection and sampling protocols, and enable the building a quality management system to measure performance improvement and accountability.
While some in the industry are bemoaning FDA’s continued engagement in listening sessions on the Traceability Rule, with compliance not due until 2028, it seems to make sense for the agency to continue working with the industry to ensure understanding and discuss best means of compliance. FDA has stated that the rule, itself, is not changing; so using the nearly two remaining years to address common questions and issues and work with industry on furthering an interoperable system that speeds traceability through the supply chain is simply fulfilling the intent of the extension.
Summary: The FDA is continuing to advance the implementation of the FSMA Traceability Rule (FSMA 204) by releasing new guidance and hosting industry listening sessions in partnership with the Partnership for Food Traceability. With the compliance deadline set for July 2028, the agency encourages companies across the supply chain to start preparing for expanded traceability recordkeeping requirements and operational changes.
