The U.S. Food and Drug Administration (FDA) has announced the release of their finalized Food Traceability Rule.
The final rule, which is part of FDA’s implementation of FSMA (Pub. L. 111-353), establishes additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods for which the Agency has determined these additional requirements are appropriate and necessary to protect the public health in accordance with FSMA. These traceability recordkeeping requirements will help FDA rapidly and effectively identify recipients of such foods to prevent or mitigate a foodborne illness outbreak and address threats of serious adverse health consequences or death as a result of such foods being adulterated or misbranded (with respect to allergen labeling) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements will reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected by these outbreaks by improving the ability to quickly and efficiently trace the movement through the supply chain of foods identified as causing illness, identify and remove contaminated foods from the marketplace, and develop mitigation strategies to prevent future contamination.
The rule requires persons 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. Entities that grow or raise an FTL food (other than eggs) will also need to keep (as part of their traceability plan) a farm map showing the area in which the food is grown or raised, including geographic coordinates for the growing/raising area. Harvesters and coolers of raw agricultural commodities (RACs) (not obtained from a fishing vessel) that are on the FTL must keep records of their activities and provide information on them to the initial packers of these RACs. These initial packers, along with the first land- based receivers of FTL foods obtained from a fishing vessel, as well as entities that transform an FTL food (by manufacturing/processing a food or by changing the food or its packaging or labeling), must assign a traceability lot code to the food to help ensure accurate identification of the food as it moves through the supply chain, as well as maintain other records relating to their activities. Shippers and receivers of FTL foods must keep records of these actions, and shippers must provide the traceability lot code and other information identifying the food to the recipients of the food, including information relating to the traceability lot code source (i.e., the entity that assigned the traceability lot code to the food). To avoid disclosing confidential information about their suppliers, instead of directly identifying the traceability lot code source of an FTL food, the shipper may instead choose to provide a traceability lot code source “reference,” such as an FDA Food Facility Registration number or a web address (which could be configured to require authentication for access), that provides an alternative means for FDA to identify and contact the traceability lot code source for the food. Taken together, these core subpart S requirements establish a structure for maintaining and providing traceability information that will enable FDA to more rapidly and effectively identify the source of contamination when investigating a foodborne illness outbreak than is possible under existing traceability recordkeeping requirements.
Food Traceability List
The Food Traceability List identifies foods for which additional traceability records are required. Requirements apply to the listed foods and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form in which it appears on the list.
Cheese (from pasteurized milk), fresh soft or soft unripened
Cheese (from pasteurized milk), soft ripened or semi-soft
Finfish histamine-producing species
Finfish species not associated with histamine or ciguatoxin
Herbs (fresh)
Leafy greens (fresh-cut)
Nut butters
Peppers (fresh)
Smoked finfish (refrigerated and frozen)
Sprouts (fresh)
Vegetables other than leafy greens (fresh-cut) | Cheese (from unpasteurized milk), other than hard cheese Crustaceans (fresh and frozen) Cucumbers (fresh) Finfish species potentially contaminated with ciguatoxin Fruits (fresh-cut) Leafy greens (fresh) Melons (fresh) Molluscan shellfish, bivalves (fresh and frozen) Ready-to-eat deli salads (refrigerated) Shell eggs Tomatoes (fresh) Tropical tree fruits (fresh) |
Key Data Elements & Critical Tracking Events
Key Data Elements (KDEs) – or information that entities must keep and send forward – are associated with specific Critical Tracking Events (CTEs) and based on the position of an entity in the supply chain. Central to the requirements, is the assignment, recording, and sharing of traceability lot codes for FTL foods, as well as the linking of these lot codes to other identifying information of the foods as they move through the supply chain.
Harvesting: Location of harvesting; food name; quantity; date; ref. document type/no.; etc.
Packing Location of packing; food name; quantity; date of packing; lot code; ref. document type/no.; etc.
Shipping Traceability lot code; food name; quantity; description; date the food was shipped; ref. document type/no.; etc.
Receiving Traceability lot code; food name; quantity; description; date the food was received; ref. document type/no.; etc.
Receiving (of Seafood Obtained from a Fishing Vessel). Traceability lot code (if not previously established, the first receiver would be required to establish the traceability lot code and maintain records linking the traceability lot code to the other KDEs). Harvest date range and locations (National Marine Fisheries Service Ocean Geographic Code or geographical coordinates) for the trip during which the seafood was caught.
Transforming New traceability lot code; location; food name; quantity; description; date of transformation; ref. document type/no.; etc.
Traceability Plan
Required for all entities covered by the rule. Plan should include a description of procedures used to maintain records, assign lot codes, identify foods, manufacture, process, pack, or hold food; point of contact details; frequency of Plan's updates; etc. as applicable.
Exemptions | Partial & Full
The final Rule provides full and partial exemptions for some entities and foods, such as certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others.
Compliance Date
Tuesday, January 20, 2026 is the compliance date for all companies and persons subject to the Rule's recordkeeping requirements.
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This material is provided for informational purposes only. The provision of this material does not constitute legal advice. Do not take action in reliance on the contents of this material without seeking the advice of appropriate council. United Safety Agents is a private, United States-based, Limited Liability Company and is not affiliated with the United States Food and Drug Administration.