According to NGFA, the U.S. Food and Drug Administration (FDA) on Nov. 15 as mandated by the Food Safety Modernization Act (FSMA) issued a final rule to establish additional traceability requirements for certain foods intended to facilitate faster identification and effective removal of potentially contaminated foods to prevent or mitigate outbreaks of foodborne illness.
The final rule standardizes the data elements and information covered entities are to establish, maintain, and communicate to the next entity in the supply chain to facilitate rapid and accurate traceability of foods identified within FDA’s “Food Traceability List” (FTL).
Among the foods included by FDA within the final FTL are soft and semi-soft cheeses, leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, and nut butters. Importantly, the traceability requirements established by the rule apply not only to foods specifically identified within the FTL, but also to other foods that utilize FTL foods as ingredients. The compliance date for all entities subject to the new recordkeeping requirements is Tuesday, Jan. 20, 2026.
Significantly, and as advocated by NGFA in comments submitted in response to FDA’s proposed rule, the final rule does not establish additional traceability requirements for animal feed or pet food. Nor do the additional traceability requirements apply to animal foods that contain foods (or by-products from the production of food) identified in the FTL.
FDA notes in the preamble of the final rule that the agency’s risk-ranking model used to determine FTL foods is designed only for humans and cannot accommodate applicability to other animal species, largely due to the lack of data on animal food-related illnesses.
However, FDA also states the agency may consider development of an animal food risk-ranking model in the future and would intend to seek public input if it opts to develop such a model.
Meanwhile, existing FDA regulations already require human and animal food facilities and food transporters to establish and maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping).
These regulations – finalized in 2004 under the Bioterrorism Act – require most entities handling, storing, manufacturing, packing, distributing or transporting agricultural commodities, feed, feed ingredients and food products to establish, maintain and provide access to traceability records.
As such, among the types of operations subject to the existing traceability requirements are grain elevators, feed manufacturers, feed dealers, grain processors, and transporters.
Key Components of FDA’s Final Rule
FDA’s final rule that establishes additional traceability requirements for operations who manufacture, process, pack, or hold a food on the FTL focuses on the following activities deemed by the agency as critical tracking events (CTEs): harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.
For each CTE, entities are required to establish and maintain records containing key data elements (KDEs) associated with that CTE.
Examples of KDEs include the traceability lot code, the date the product was received or shipped, product description, quantity and unit of measure for the food, and location description for the food’s immediate subsequent recipient or immediate previous source.
The final rule also requires entities who manufacture, process, pack, or hold an FTL food to establish and maintain a traceability plan that, among other things, describes their procedures for maintenance of records under the new requirements, identification of FTL foods handled, and assignment of traceability lot codes to FTL foods.
In addition, in the event of a foodborne illness outbreak, a product recall, or other threat to public health, most entities are required to submit to FDA, within 24 hours of official request (or within some reasonable time to which FDA has agreed), an electronic sortable spreadsheet containing required traceability information for specific foods and date ranges.
FDA Webinar
FDA will hold an informational webinar on Dec. 7 from 1 – 5 p.m. ET to provide an overview of the final rule, including the foods and entities covered by the rule, exemptions from the rule, and the recordkeeping requirements of the rule. Submit questions in advance and register for the webinar here.