On November 15, 2022, the U.S. Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) under the Food Safety Modernization Act (FSMA) Section 204(d). The Food Traceability Final Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and associated deaths. Additionally, FDA held a briefing following the issuance of the final rule, which provided additional details and addressed stakeholder questions.
The compliance date for all operations subject to the recordkeeping requirements of the Food Traceability Final Rule is Tuesday, January 20, 2026. In its briefing, FDA clarified that no records will be requested prior to the compliance date, and that the agency will engage in stakeholder outreach, technical support, and education prior to and after January 20, 2026. FDA will provide similar support and translations of the final rule and relevant communications for foreign trading partners as well.
Foods subject to the final rule requirements appear on the Food Traceability List (FTL). The FTL includes fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat (RTE) deli salads, cheeses, and seafood products. FDA clarified during the briefing that frozen foods are not included on the FTL; however, ingredients used in final food products will be subject to the final rule if the ingredients remain in the form specified on the FTL.
Additionally, the difference between FTL foods and “high-risk” foods was made clear during the briefing, as “any food can be hazardous” if proper food safety controls are not applied. FTL foods have been determined using a framework developed by FDA that takes into account factors identified by U.S. Congress through FSMA. Such factors include incidence of associated illnesses, potential for contamination, susceptibility to pathogen growth, and others.
At the core of the final rule is a requirement that individuals who manufacture, process, pack, or hold food on the FTL maintain records including Key Data Elements (KDEs) related to Critical Tracking Events (CTEs). When requested by FDA, covered firms and farms, retail food establishments, and restaurants will be required to provide information to the agency within 24 hours, or another reasonable time to which FDA agrees. FDA officials elaborated during the briefing that records would be requested in the event of food safety incidents, and that records for individual establishments can be kept offsite as long as they are able to be produced onsite within 24 hours.
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, foods that receive certain types of processing, and other specified operations. The final rule aligns with current industry best practices and covers domestic firms, retail food establishments, restaurants, and farms, as well as foreign firms and farms producing food for U.S. consumption.
As discussed in the FDA briefing, several changes were made when finalizing the rule based on stakeholder comments. For example, nonessential KDEs were eliminated from the final rule and certain KDEs were renamed. The compliance date was also extended, and revisions to exemptions or provisions for certain establishments or foods were made. Finally, changes were made to specific CTE terms and more detailed descriptions were added to the FTL.
FDA will be holding a webinar on December 7, 2022, from 1:00–5:00 P.M. ET, to discuss the final rule at greater length and address stakeholder questions. Registration information will be made available in the near future. During the webinar, FDA will provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and discuss the recordkeeping requirements of the rule. FDA will answer pre-submitted questions and take questions during the webinar. Register for the webinar here.
Food Traceability Final Rule in the New Era of Smarter Food Safety
During the briefing, Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, expressed how the Food Traceability Final Rule is a “landmark, game-changing, and transformational” rule with the end goal of facilitating industry’s ability to track a food at every step along the supply chain continuum. Mr. Yiannas elaborated upon how the final rule will enable speedier adoption of tech-enabled traceability, a pillar of the New Era of Smarter Food Safety Blueprint. The final rule establishes a universal language that can be leveraged to increase the use and availability interoperable data, improving the agency’s and industry’s abilities to trace the movement of food and respond to food safety incidents. “The final rule will pave the way for more digital, traceable systems in the near future,” said Mr. Yiannas.
The Food Traceability Final Rule has been issued ahead of the upcoming Food Safety Magazine webinar with FDA on its contents. The webinar is the second installment in an ongoing, four-part series on FDA’s New Era of Smarter Food Safety Blueprint, of which the Food Traceability Final Rule is also a key component. The webinar will take place November 29, 2022 at 2:00 P.M. ET and will feature Frank Yiannas, along with other FDA and industry speakers.
Key Features of the Final Rule
Critical Tracking Events (§ 1.1325 through 1.1350)
The final rule identifies CTEs for which records containing KDEs will be required. The KDEs required will vary depending on the CTE that is being performed.
The Critical Tracking Events in the final rule are 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.
- Harvesting: applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food.
- Cooling: active temperature reduction of a RAC using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.
- Initial packing: packing a RAC, other than a food obtained from a fishing vessel, for the first time.
- First land-based receiver: the person taking possession of a food for the first time on land directly from a fishing vessel.
- Shipping: an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
- Receiving: an event in a food’s supply chain in which a food is received by someone other than a consumer after being transported (e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location of the firm at a different street address.
- Transformation: an event in a food’s supply chain that involves manufacturing, processing, or changing a food (e.g., by commingling, repacking, or relabeling), or its packaging or packing, when the output is a food on the FTL. Transformation does not include the initial packing of a food or activities preceding that event (e.g., harvesting or cooling).
Traceability Lot Code
Traceability lot code (TLC) is defined as a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the TLC. Individuals must assign a traceability lot code to a food on the FTL in any of the following instances:
- Initial packaging of a RAC, other than a food obtained from a fishing vessel
- First land-based receiving of a food obtained from a fishing vessel
- Transformation of a food.
If receiving an FTL food from an entity that is exempt from the final rule, the receiver must assign a TLC if one has not already been assigned (excluding retail food establishments or restaurants). Otherwise, receivers must not establish a new TLC when conducting other activities (e.g., shipping) for a food on the FTL. Once a food has been assigned a TLC, the records required at each CTE must include that TLC. All of the KDEs, including the TLC, must be linked to the relevant traceability lot.
Traceability Plan (§ 1.1315)
Those subject to the requirements of the final rule must establish and maintain a traceability plan containing the following information:
- A description of the procedures used to maintain the required records, including the format and location of the records
- A description of the procedures used to identify foods on the FTL that are manufactured, processed, packed, or held
- A description of traceability lot codes assigned to foods on the FTL, if applicable
- A statement identifying a point of contact for questions regarding a traceability plan and records
- If applicable, a farm map showing the areas in which FTL foods (other than eggs) are grown.
Farm maps must show the location and name of each field (or other growing area) in which FTL foods are grown, including geographic coordinates and any other information needed to identify the location of each field or growing area. For aquaculture farms, farm maps must show the location and name of each container (e.g., pond, pool, tank, or cage) in which FTL seafood is raised, including geographic coordinates and any other information needed to identify the location of each container.
Additional Requirements (§ 1.1455)
The final rule also requires records to be maintained as original paper or electronic records, or true copies. Records must be legible and stored to prevent deterioration or loss. Electronic records may include valid, working electronic links to the information required to be maintained under the rule.
All records required under the final rule, along with any information required to understand the records, must be made available to FDA within 24 hours after a request is made (or within a reasonable time to which FDA has agreed). Additionally, unless exempt, an electronic sortable spreadsheet containing relevant traceability information must be provided to FDA within 24 hours of a request (or within some reasonable time to which FDA has agreed) when necessary to assist FDA during an outbreak, recall, or other threat to public health.
The Food Traceability List
Foods included on the FTL, which are therefore subject to the Food Traceability Final Rule, are as follows:
- Cheese (made from pasteurized milk), fresh-soft or soft-unripened: examples include, but are not limited to, cottage, chevre, cream cheese, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna. Does not include cheeses that are frozen, shelf-stable at ambient temperature, or aseptically processed and packaged.
- Cheese (made from pasteurized milk), soft-ripened or semi-soft: examples include, but are not limited to, brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster. Does not include cheeses that are frozen, shelf-stable at ambient temperature, or aseptically processed and packaged.
- Cheese (made from unpasteurized milk), other than hard cheese: Does not include cheeses that are frozen, shelf-stable at ambient temperature, or aseptically processed and packaged.
- Shell eggs: the egg of the domesticated chicken.
- Nut butters: all types of tree nut and peanut butters. Examples include, but are not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters. Does not include soy or seed butters.
- Fresh cucumbers: all varieties.
- Fresh herbs: all varieties. Examples include, but are not limited to, parsley, cilantro, and basil. Herbs listed in 21 CFR 112.2(a)(1), such as dill, are exempt from the requirements of the rule under 21 CFR 1.1305(e).
- Fresh leafy greens: all varieties.
- Fresh-cut leafy greens: all varieties, including single and mixed greens.
- Fresh melons: all varieties. Examples include, but are not limited to, cantaloupe, honeydew, muskmelon, and watermelon.
- Fresh peppers: all varieties.
- Fresh sprouts: all varieties (irrespective of seed source), including single and mixed sprouts. Examples include, but are not limited to, alfalfa sprouts, allium sprouts, bean sprouts, broccoli sprouts, clover sprouts, radish sprouts, alfalfa and radish sprouts, and other fresh sprouted grains, nuts, and seeds.
- Fresh tomatoes: all varieties.
- Fresh tropical tree fruits: all varieties of fresh tropical tree fruit. Examples include, but are not limited to, mango, papaya, mamey, guava, lychee, jackfruit, and starfruit. Does not include non-tree fruits such as bananas, pineapple, dates, soursop, jujube, passionfruit, loquat, pomegranate, sapodilla, and figs. Does not include tree nuts such as coconut. Does not include pit fruits such as avocado. Does not include citrus, such as orange, clementine, tangerine, mandarins, lemon, lime, citron, grapefruit, kumquat, and pomelo.
- Fresh-cut fruits Fresh-cut vegetables other than leafy greens: all varieties of fresh-cut vegetables other than leafy greens. Vegetables listed in § 112.2(a)(1) are exempt from the requirements of the rule under § 1.1305(e).
- Fresh and frozen finfish, histamine-producing species: all histamine-producing species of finfish. Examples include, but are not limited to, tuna, mahi mahi, mackerel, amberjack, jack, swordfish, and yellowtail.
- Fresh and frozen finfish species potentially contaminated with ciguatoxin: all finfish species potentially contaminated with ciguatoxin. Examples include, but are not limited to, grouper, barracuda, and snapper.
- Fresh and frozen finfish species not associated with histamine or ciguatoxin: all species of finfish not associated with histamine or ciguatoxin. Examples include, but are not limited to, cod, haddock, Alaska pollock, salmon, tilapia, and trout. Siluriformes fish, such as catfish, are not included.
- Refrigerated and frozen smoked finfish: all varieites of smoked finfish, including cold smoked finfish and hot smoked finfish.
- Fresh and frozen crustaceans: all crustacean species. Examples include but are not limited to shrimp, crab, lobster, and crayfish.
- Fresh and frozen molluscan shellfish, bivalves: all species of bivalve mollusks. Examples include, but are not limited to, oysters, clams, and mussels. Does not include scallop adductor muscle. Raw bivalve molluscan shellfish that are (1) covered by the requirements of the National Shellfish Sanitation Program; (2) subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or (3) covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish are exempt from the requirements of the rule under § 1.1305(f).
- Refrigerated RTE deli salads: all varieties of refrigerated RTE deli salads. Examples include, but are not limited to, egg salad, potato salad, pasta salad, and seafood salad. Does not include meat salads.
For more information about the Food Traceability Final Rule, including answers to frequently asked questions, supply chain examples, information about KDEs required for each CTE performed, and exemptions, visit FDA’s dedicated webpage.
Update, November 15, 2022: Additions were made to the article to include details from FDA's briefing on the Food Traceability Final Rule.
Update, November 17, 2022: Edits were made to the article to include the details of FDA's December 7, 2022 webinar.