FDA's Food Traceability Rule (FSMA Section 204) requires every company that manufactures, processes, packs, or holds foods on the Food Traceability List to maintain lot-level traceability records and produce them in electronic sortable format within 24 hours of an FDA request. The original compliance date was January 20, 2026. Congress directed FDA not to enforce it until July 20, 2028. That gives you 30 extra months. But Walmart, Costco, Kroger, and other major retailers are already requiring this data from their suppliers today. If you import fresh leafy greens, tomatoes, peppers, melons, cheeses, shell eggs, nut butters, tropical fruits, finfish, or any product containing these as ingredients, the clock is running regardless of what FDA does. Here is what the rule requires, which of your products are covered, and how to build the system before your biggest customer asks for it.
Key Takeaways
The FSMA Food Traceability Rule requires enhanced recordkeeping for foods on the Food Traceability List (FTL). The compliance date has been extended to July 20, 2028. FDA requirements have not changed, only the enforcement timeline.
The FTL covers 16 categories of high-risk foods: cheeses, shell eggs, nut butters, cucumbers, herbs, fresh leafy greens, fresh-cut leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits, fresh-cut vegetables, finfish, and smoked finfish.
The rule also applies to foods that contain FTL items as ingredients, provided the listed food remains in the same form as it appears on the FTL.
Companies must record Key Data Elements (KDEs) at each Critical Tracking Event (CTE) in the supply chain: growing, harvesting, cooling, initial packing, receiving, transforming, and shipping.
Records must be produced in electronic sortable format (spreadsheet) within 24 hours of an FDA request. Manual, paper-based systems will not meet this requirement.
Records must be maintained for at least 2 years.
The rule applies equally to U.S. importers and their foreign suppliers. Foreign food safety authorities are not responsible for verifying compliance. The burden falls on the business.
Major retailers are already requiring FSMA 204-compliant traceability data from suppliers, effectively making compliance mandatory before the federal enforcement date.
What Is the FSMA Food Traceability Rule?
Section 204(d) of the Food Safety Modernization Act directs FDA to designate high-risk foods for which enhanced traceability records are required. The resulting Food Traceability Final Rule (21 CFR Part 1, Subpart S) establishes specific recordkeeping requirements for companies that handle foods on the Food Traceability List.
The short answer is: for certain high-risk foods, FDA wants to be able to trace every lot from the farm to the store shelf within 24 hours. The rule tells you exactly what data to collect, when to collect it, and how fast you must hand it over.
Key definition: Food Traceability List (FTL) is the FDA-designated list of foods for which enhanced traceability records are required. Inclusion is based on risk criteria including frequency and severity of foodborne illness outbreaks associated with the food, likelihood of contamination, and potential for widespread distribution.
Key definition: Critical Tracking Event (CTE) is a point in the supply chain where enhanced traceability recordkeeping is required. CTEs include growing, receiving, transforming (mixing, repackaging, cooking), creating, shipping, harvesting, cooling, and initial packing.
Key definition: Key Data Element (KDE) is a specific piece of information that must be recorded at each CTE. KDEs include product descriptions, lot codes, quantities, unit of measure, dates, locations, and points of contact.
Key definition: Traceability Lot Code (TLC) is a unique alphanumeric identifier assigned to a traceability lot. It links all records for that lot across the entire supply chain.
Which Foods Are on the Food Traceability List?
| FTL Category | Examples | Common Import Origins |
|---|---|---|
| Fresh leafy greens | Lettuce, spinach, kale, arugula, chard | Mexico, Canada, Central America |
| Fresh-cut leafy greens | Bagged salad mixes, pre-washed greens | Mexico, multiple origins |
| Tomatoes | Fresh tomatoes (not canned or processed) | Mexico, Canada, Central America |
| Peppers | Fresh peppers (hot and sweet varieties) | Mexico, Central America, Asia |
| Cucumbers | Fresh cucumbers | Mexico, Central America |
| Melons | Cantaloupe, honeydew, watermelon | Mexico, Central America, Brazil |
| Sprouts | All varieties of sprouted seeds | Various |
| Herbs | Fresh herbs (cilantro, basil, parsley, etc.) | Mexico, Central America, Colombia, Israel |
| Tropical tree fruits | Mango, papaya, guava, starfruit | Mexico, Central America, India, Southeast Asia |
| Fresh-cut fruits | Pre-cut fruit mixes and containers | Multiple origins |
| Fresh-cut vegetables | Pre-cut vegetable mixes and containers | Multiple origins |
| Finfish | Fresh and frozen finfish (tuna, salmon, tilapia, etc.) | Global: Asia, South America, Europe, Iceland, Canada |
| Smoked finfish | Smoked salmon, smoked trout, etc. | Europe, Canada, Asia |
| Cheeses (certain soft types) | Fresh soft cheeses, soft-ripened cheeses | Europe, Mexico, Middle East |
| Shell eggs | Whole eggs in shell | Canada, Mexico, Europe |
| Nut butters | Peanut butter, almond butter, etc. | Various (ingredients sourced globally) |
Critical for importers: The rule also covers any food product that contains an FTL food as an ingredient, provided the FTL food remains in the same form. A frozen meal containing fresh-cut leafy greens is covered. A soup containing cooked spinach (no longer in fresh form) may not be. The distinction matters for your product portfolio assessment.
What Must You Track and When?
Each CTE requires a specific set of KDEs. The requirements differ depending on whether you are the grower, the packer, the receiver, the transformer, or the shipper. For importers, the most relevant CTEs are receiving and shipping.
When You Receive an FTL Food
You must record the Traceability Lot Code (TLC) of the food, the quantity and unit of measure, the product description, the date you received the food, the location where you received it (with sufficient specificity to identify the building or area), the location identifier for the immediate previous source (the supplier), and a point of contact for the immediate previous source.
When You Ship an FTL Food
You must record the TLC, the quantity and unit of measure, the product description, the location where you shipped from, the date you shipped, the location identifier for the immediate subsequent recipient, and a point of contact for the recipient.
When You Transform an FTL Food
If you repackage, commingle, or otherwise transform an FTL food, you must record the TLC of the input food(s), the new TLC you assign to the output food, the date of transformation, and the product description of the new food.
The 24-Hour Rule: Why Paper Will Not Work
When FDA requests your traceability records (during an outbreak investigation, a recall, or an inspection), you must produce them in electronic sortable format within 24 hours. Electronic sortable format means a spreadsheet (CSV, Excel) or database output that FDA can sort, filter, and search.
The short answer is: if your traceability records are in filing cabinets, binders, handwritten logs, or unsearchable PDFs, you cannot comply with this rule.
For a mid-market food importer handling 50 to 200 SKUs from multiple origins, the 24-hour window means your system must be able to pull every lot of a specific product, from a specific supplier, received during a specific time period, and present it in a format FDA can work with, within one business day. Building that capability takes months, not days.
The Deadline Moved. The Requirement Did Not.
Congress directed FDA not to enforce the Food Traceability Rule before July 20, 2028. FDA has stated it intends to comply with this directive. The requirements of the rule have not changed.
This means you have until July 20, 2028, before FDA can cite you for noncompliance. But three forces are making compliance necessary well before then.
1. Retailers Are Already Requiring It
Walmart, Kroger, Costco, and other major food retailers have begun requiring FSMA 204-compliant traceability data from their suppliers. If you sell to these retailers or supply their private label programs, your customers are imposing the rule's requirements on you regardless of the federal enforcement timeline. Losing a major retail customer because you cannot provide lot-level traceability data is a business problem that no compliance extension solves.
2. Your Foreign Suppliers Need Time to Build Capability
The FSMA 204 traceability chain starts at the farm or the fishing vessel. Your foreign supplier must assign Traceability Lot Codes, capture KDEs at harvest, cooling, and packing, and transmit that data to you so you can maintain your own records. Many foreign suppliers, especially in developing markets, do not have the systems to do this today. Getting them to implement lot-level traceability with electronic data exchange takes 12 to 18 months of coordination, system development, and testing.
3. An Outbreak Will Not Wait for the Deadline
If a foodborne illness outbreak is linked to one of your products, FDA will request traceability records whether or not the formal enforcement date has arrived. Your ability to identify the lot, the supplier, the harvest date, and every downstream recipient within 24 hours determines whether you contain a targeted recall to a single lot or face a full category recall that destroys your brand.
How to Build Your FSMA 204 System
Step 1: Identify Every FTL Product in Your Portfolio
Map your entire product catalog against the Food Traceability List. Include not just products that are directly on the FTL, but also products that contain FTL foods as ingredients in the same form. This is your scope.
Step 2: Assess Your Current Traceability Capability
For each FTL product, document how lot-level information currently flows through your supply chain. Can you trace a specific lot back to a specific supplier, harvest date, and growing location? Can you trace it forward to every customer who received it? Can you produce that information electronically within 24 hours? If the answer to any of these is no, you have a gap.
Step 3: Coordinate With Foreign Suppliers
Communicate the FSMA 204 requirements to every foreign supplier who provides FTL foods. Specify the KDEs you need them to capture and transmit. Agree on data formats (GS1 standards are recommended for interoperability). Begin testing data exchange on a pilot basis before rolling out across your full product portfolio.
Step 4: Implement or Upgrade Your Traceability System
Whether you use a dedicated traceability platform, an ERP module, or a structured spreadsheet system, it must be capable of capturing KDEs at each CTE, linking records through Traceability Lot Codes, producing electronic sortable output (CSV or equivalent) within 24 hours, and maintaining records for at least 2 years.
Step 5: Write Your Traceability Plan
The rule requires a written traceability plan that describes how you capture, store, and maintain KDEs and TLCs, the format and location of your records, your process for assigning TLCs, a list of FTL foods you handle, and a designated point of contact responsible for the plan.
Step 6: Test the 24-Hour Clock
Simulate an FDA records request. Pick a random FTL product, a random lot, and a random date range. Time how long it takes to pull every record associated with that lot from receiving through shipping. If it takes more than 24 hours, your system is not ready.
Frequently Asked Questions
What is the FSMA Food Traceability Rule?
A regulation under FSMA Section 204(d) requiring enhanced traceability recordkeeping for foods on the Food Traceability List. Companies that manufacture, process, pack, or hold FTL foods must record Key Data Elements at Critical Tracking Events and produce records in electronic sortable format within 24 hours of an FDA request.
When is the compliance deadline?
The enforcement date has been extended to July 20, 2028. The original date was January 20, 2026. The requirements have not changed, only the enforcement timeline.
Which foods are covered?
The Food Traceability List includes fresh leafy greens, fresh-cut leafy greens, tomatoes, peppers, cucumbers, melons, sprouts, herbs, tropical tree fruits, fresh-cut fruits, fresh-cut vegetables, finfish, smoked finfish, certain cheeses, shell eggs, and nut butters. Foods containing FTL items as ingredients (in the same form) are also covered.
Does this apply to imported food?
Yes. The rule applies equally to domestic and imported food. Foreign food safety authorities (like CFIA in Canada) are not responsible for verifying compliance. The burden falls on the U.S. importer and the foreign supplier.
What is a Traceability Lot Code?
A unique alphanumeric identifier assigned to a traceability lot. It links all records for that lot across the supply chain. GS1 standards recommend using a Global Trade Item Number (GTIN) plus the product lot code to create a unique TLC.
What is the 24-hour rule?
When FDA requests your traceability records, you must produce them in electronic sortable format (spreadsheet) within 24 hours. Paper records, handwritten logs, and unsearchable PDFs do not meet this requirement.
How long must I keep records?
At least 2 years (24 months).
Do I need a traceability plan?
Yes. The rule requires a written traceability plan describing your processes for capturing KDEs, assigning TLCs, storing records, and designating a responsible point of contact.
If the deadline is 2028, why should I start now?
Three reasons: major retailers are already requiring FSMA 204-compliant data from suppliers, building lot-level traceability with foreign suppliers takes 12 to 18 months, and an outbreak investigation will not wait for the enforcement date. Starting now gives you a competitive advantage over importers who wait until 2027.
Does my customs broker play a role in FSMA 204 compliance?
Your customs broker does not directly capture traceability data, but a broker who understands FSMA 204 can flag FTL products during the entry process, coordinate with your compliance team on lot-level documentation requirements, and ensure that prior notice and FSVP filings align with your traceability records. See our guide on choosing a customs broker for food imports.
What happens if I cannot produce records within 24 hours during an outbreak?
FDA may expand the scope of the recall beyond the specific lot in question, potentially covering your entire product category. The inability to trace a specific lot forces a broader, more costly response that damages your brand and your customer relationships.
Can compliance with another country's traceability rules substitute for FSMA 204?
No. Compliance with Canada's SFCR, the EU's traceability requirements, or any other country's regulations does not guarantee compliance with FSMA 204. The KDEs, CTEs, and electronic format requirements are specific to the U.S. rule.
This guide reflects FSMA Section 204 Food Traceability Rule requirements, the Congressional enforcement extension to July 20, 2028, and retailer compliance trends as of April 3, 2026. The rule's requirements have not been amended. Importers should monitor FDA.gov for final rulemaking on the compliance date extension and review the Food Traceability List for applicability to their products. For related topics, see our guides on FSVP compliance, FDA import compliance, prior notice filing, FDA holds on perishable food, food labeling for imports, and choosing a customs broker for food imports.
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