1. What Is the FDA Food Traceability List (FTL)?
The FDA Food Traceability List (FTL) is a specific enumeration of food commodities that are subject to enhanced recordkeeping requirements under the FDA's Food Safety Modernization Act (FSMA) Section 204 rule, formally titled "Requirements for Additional Traceability Records for Certain Foods."
Not every food is on the FTL. The FDA deliberately limited the list to foods with a history of serious foodborne illness outbreaks — the commodities most frequently linked to large-scale recalls, deaths, and hospitalizations. If your product is on the FTL, you face significantly more documentation obligations than standard FSMA recordkeeping. If your product is not on the FTL, the enhanced requirements under Section 204 do not apply, though general FSMA recordkeeping rules still do.
The core purpose of the FTL and the broader Section 204 rule is to enable the FDA to rapidly trace the source of contaminated food during an outbreak — reducing the time it takes to identify and remove contaminated product from commerce from days or weeks down to hours.
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2. Why Was the FTL Created? FSMA Section 204 History
The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011 — the most sweeping overhaul of U.S. food safety law in more than 70 years. FSMA shifted the FDA's focus from reacting to foodborne illness outbreaks to preventing them in the first place.
Section 204 of FSMA specifically directed the FDA to establish recordkeeping requirements for high-risk foods to improve the agency's ability to rapidly identify and respond to outbreaks. Congress gave the FDA broad authority to determine which foods to include based on risk factors including:
- The known safety risks of the food
- The likelihood that the food will be implicated in serious foodborne illness
- The potential severity of the illness associated with the food
- The scale of production and distribution of the food
- The number of outbreaks associated with the food in recent history
The FDA finalized the Food Traceability Rule in November 2022 after years of stakeholder input, pilot programs, and public comment. The rule was grounded in data: the foods on the FTL collectively account for a disproportionate share of the thousands of hospitalizations and dozens of deaths attributable to foodborne illness each year in the United States.
High-profile outbreaks involving romaine lettuce, cantaloupe, raw oysters, and ready-to-eat deli products demonstrated how slow traceback investigations — sometimes taking weeks — allow contaminated food to remain in commerce long after an outbreak is identified. The FTL and its associated requirements are designed to eliminate that delay.
3. Enforcement Timeline: Original Deadline vs. July 2028
Understanding the enforcement timeline is critical for compliance planning. The dates have shifted, and being aware of the current deadline prevents both false urgency and dangerous complacency.
The Original January 2026 Deadline
When the FDA finalized the Food Traceability Rule in November 2022, it set an initial compliance deadline of January 20, 2026 — giving the food industry approximately three years to implement the required systems and processes. This timeline was intended to allow businesses sufficient time to audit their supply chains, upgrade recordkeeping systems, and train staff on the new requirements.
The Extended July 2028 Deadline
In January 2025, the FDA announced it was extending the compliance deadline to July 20, 2028. The extension was granted in recognition of the significant operational burden the rule places on small and mid-sized food businesses, many of which still rely on paper-based recordkeeping. The FDA indicated the additional time would allow the agency to provide further guidance, develop educational resources, and support industry readiness without compromising the rule's public health objectives.
The extended deadline does not mean businesses should delay compliance planning. Supply chain traceability systems — especially those that require coordination across multiple trading partners — take 12 to 24 months to implement properly. Organizations that begin in 2027 will find themselves in a race against a hard deadline with limited vendor capacity and no room for iteration.
4. All Food Categories on the FTL (Complete List)
The following food categories appear in the FDA's Food Traceability List as published in the final rule (21 CFR Part 1, Subpart S). For each category, the FDA specifies which Critical Tracking Events apply. The descriptions below reflect the regulatory text; always consult the current rule and FDA guidance for authoritative classification decisions.
Cheeses (Other Than Hard Cheeses)
This category covers soft and semi-soft cheeses including fresh mozzarella, brie, camembert, ricotta, cottage cheese, cream cheese, and queso fresco. Hard cheeses — defined as those with a moisture content of 39% or less (such as aged cheddar, parmesan, and romano) — are excluded from the FTL. The distinction matters because hard cheeses' low moisture content inhibits the growth of pathogens like Listeria monocytogenes, which has been responsible for deadly outbreaks linked to soft cheeses, particularly those made from unpasteurized milk.
Shell Eggs
Shell eggs are included due to their longstanding association with Salmonella Enteritidis contamination. Note that liquid, frozen, and dried egg products are not on the FTL — the enhanced requirements apply specifically to whole shell eggs sold for human consumption. Shell egg producers and distributors operating under the FDA's Shell Egg rule should be aware that Section 204 requirements layer on top of existing egg safety regulations.
Nut Butters
Nut butters made from any nut — including peanut butter, almond butter, cashew butter, and sunflower seed butter — are on the FTL. This inclusion follows several large-scale Salmonella outbreaks linked to peanut butter manufacturing facilities, including the 2009 Peanut Corporation of America outbreak that resulted in nine deaths and over 700 confirmed illnesses across 46 states. The widespread distribution of nut butters, combined with their dry-environment Salmonella risk, makes traceback capability especially important.
Fresh Produce (Specific Commodities)
Not all fresh produce is on the FTL — only the following specific commodities appear:
- +Cucumbers — Fresh cucumbers have been linked to multiple Salmonella outbreaks. Sliced cucumbers used in food service settings present particular risk due to cross-contamination potential.
- +Fresh herbs — Including basil, cilantro, parsley, and related leafy herbs often consumed raw. Cyclospora and Salmonella outbreaks have been linked to fresh herbs, particularly those imported from certain regions.
- +Leafy greens — This is the single largest FTL category by volume and public health significance. It includes all lettuce varieties (romaine, iceberg, butterhead, leaf lettuce), spinach, arugula, kale, chard, and similar greens. Romaine lettuce alone has been implicated in at least five major E. coli O157:H7 outbreaks since 2017, affecting hundreds of people and prompting region-wide advisories. Leafy greens subject to the Produce Safety Rule (grown in the U.S.) are also covered under FSMA 204.
- +Melons — Cantaloupe, honeydew, and watermelon. Cantaloupes have been responsible for some of the deadliest produce-linked outbreaks in U.S. history, including a 2011 Listeria outbreak that killed 33 people. The rough netted exterior of cantaloupe provides pathogen harborage points that make post-harvest handling especially critical.
- +Peppers — Fresh peppers (bell peppers, hot peppers, jalapeños, etc.) have been linked to Salmonella outbreaks, including a 2008 outbreak that was initially — and incorrectly — attributed to tomatoes before investigators traced the source to Serrano peppers. That misdirection caused hundreds of millions of dollars in tomato industry losses and highlighted the importance of rapid, accurate traceback.
- +Sprouts — Bean sprouts, alfalfa sprouts, and other sprouted seeds. The warm, humid conditions required for sprouting create an ideal environment for Salmonella and E. coli growth. Sprouts have been associated with over 30 outbreaks in the U.S. since the 1990s.
- +Tomatoes — Fresh tomatoes have been implicated in Salmonella outbreaks. As noted with the pepper/tomato outbreak above, the similar appearance and overlapping supply chains of tomatoes and peppers make accurate traceability infrastructure especially important for these commodities.
- +Tropical tree fruits — Papayas, mangoes, and similar tropical fruits. Papayas in particular have been linked to Salmonella outbreaks, with contamination often occurring during post-harvest handling and packing operations in tropical growing regions.
Fresh-Cut Fruits and Vegetables
Fresh-cut produce is any raw produce that has been peeled, sliced, diced, shredded, chopped, or similarly processed and packaged for consumer convenience. This category applies broadly — fresh-cut versions of produce that are not themselves on the FTL (such as apples or celery) may still be covered under the fresh-cut category. The cutting and processing steps that make fresh-cut produce convenient also remove the natural protective barriers of intact produce skin, dramatically increasing microbial risk.
Finfish
The FDA divides finfish on the FTL into three hazard categories based on their biological risk profile:
- Finfish intended for raw consumption — Such as sushi-grade tuna, salmon, yellowtail, and similar species served without cooking.
- Finfish in the Scombridae family or that produce scombrotoxin — Including tuna, mackerel, mahi-mahi, and amberjack, which can produce histamine (scombrotoxin) when not properly refrigerated. Scombrotoxin fish poisoning is one of the most common forms of seafood-associated illness.
- Siluriformes (catfish) — Catfish and related species, which have been subject to specific FDA oversight due to import safety concerns.
Smoked Finfish
Hot-smoked and cold-smoked fish (including smoked salmon, smoked trout, and smoked whitefish) are on the FTL. Cold-smoked fish in particular carries significant Listeria risk because the smoking process does not reach temperatures sufficient to destroy the pathogen. Ready-to-eat smoked fish products have been implicated in multiple Listeria outbreaks. Note that smoked finfish is listed separately from fresh finfish — each has its own set of Critical Tracking Events.
Crustaceans
Shrimp, crab, lobster, crayfish, and similar crustaceans intended for human consumption are covered under the FTL when sold in ready-to-eat form or intended for raw consumption. Crustaceans represent a high-volume seafood category with complex international supply chains, making robust traceability especially challenging — and especially important.
Molluscan Shellfish
Oysters, clams, mussels, scallops, and similar bivalve mollusks are among the highest-risk foods on the FTL. Molluscan shellfish are filter feeders that concentrate pathogens — including norovirus, Vibrio, and hepatitis A — from their growing waters. They are frequently consumed raw or lightly cooked. Molluscan shellfish are already subject to the National Shellfish Sanitation Program (NSSP), but FSMA 204 adds additional traceability recordkeeping requirements on top of existing state and federal programs.
Ready-to-Eat Deli Salads
Ready-to-eat deli salads containing meat, poultry, or seafood — such as chicken salad, tuna salad, egg salad, and seafood salads — are covered under the FTL. These products are made from multiple ingredients with distinct supply chains, are consumed without further cooking, and are typically produced in environments where Listeria contamination is a persistent risk. Multi-ingredient RTE products present some of the most complex traceability challenges under the rule.
5. Critical Tracking Events (CTEs) Explained
Critical Tracking Events (CTEs) are the specific points in a food's supply chain journey at which a business must create and maintain traceability records. The FDA has defined CTEs because not every transaction or movement along the supply chain requires enhanced documentation — only the events most likely to be relevant to a traceback investigation.
The five standard CTEs defined by the FDA are:
Growing (Harvesting)
For produce, this is the event at which food is harvested from the growing area. The farm or harvesting operation must create a record at this point that includes information about the growing area location, harvest date, and the traceability lot code assigned to the harvested lot.
Cooling (First Cooler)
For produce that undergoes initial cooling after harvest, the first cooling event is a CTE. This is the point at which the lot enters controlled temperature conditions, and records must capture the location, date, and lot identification.
Transforming (Initial Packing / Processing)
Transformation occurs when an FTL food is packed into a retail unit for the first time, or when it is processed or otherwise transformed into a different product. A new traceability lot code is created at this event, and the record must link back to the inputs and their lot codes — this linkage is the core of what makes the system work for traceback investigations.
Shipping
Every time an FTL food is shipped from one entity to another, the shipper must create a record. This record captures the traceability lot code, quantity, product description, the location from which the food is shipped, the location to which it is being shipped, and the date of shipment.
Receiving
The receiving entity must create a record when it receives an FTL food. The receiving record must capture the same key information as the shipping record, plus the date of receipt. Together, shipping and receiving records create the chain of custody documentation that enables rapid traceback.
Not every CTE applies to every food category on the FTL. The FDA has specified which CTEs are required for each category in the rule. For example, the Growing/Harvesting CTE applies to fresh produce but not to cheeses or nut butters, which have their own relevant starting points. Use our FTL lookup tool to see the specific CTEs required for your product category.
6. Key Data Elements (KDEs) Explained
Key Data Elements (KDEs) are the specific pieces of information that must be captured at each Critical Tracking Event. The FDA requires that this information be maintained in records that can be provided to the agency within 24 hours of a request during a foodborne illness investigation.
While the specific KDEs vary by CTE and food category, the core elements required across most scenarios include:
- TLCTraceability Lot Code (TLC)
A unique identifier assigned to a specific lot of FTL food at the point it is harvested, packed, or transformed. The TLC is the linchpin of the entire traceability system — it is how lots are tracked across the supply chain.
- TLC sourceTraceability Lot Code Source
The location (farm, facility, or other entity) where the TLC was initially assigned. This information allows investigators to identify the origin of any lot in the supply chain.
- QuantityQuantity and Unit of Measure
How much of the food was in the lot, expressed in a standard unit (e.g., pounds, cases, units).
- DescriptionProduct Description
A description of the food sufficient to identify it, which may include commodity type, variety, brand, and packaging type.
- LocationLocation Descriptors
The name and physical location (or FDA-registered facility number) of the entity originating the record and, for shipping/receiving CTEs, the destination and origin locations.
- DateEvent Date
The date on which the CTE occurred (harvest date, shipping date, receiving date, etc.).
- ReferenceReference Document Type and Number
The type and identifier of any associated business document (e.g., bill of lading number, purchase order number) that references the traceability lot code.
The FDA does not mandate a specific format for KDE records — paper, spreadsheets, and electronic systems are all acceptable — but the records must be retrievable and shareable with the FDA within 24 hours of a request. In practice, this 24-hour retrieval requirement strongly incentivizes electronic systems over paper-based approaches.
7. Who Needs to Comply
FSMA 204's traceability requirements apply to any entity that manufactures, processes, packs, or holds FTL foods — unless a specific exemption applies. This encompasses a broad range of business types across the supply chain:
Farms and Growers
Farms producing FTL produce commodities must create and maintain records at the Growing/Harvesting CTE. This includes the assignment of traceability lot codes at the time of harvest and documentation of the growing area location.
Processors and Packers
Facilities that pack, process, or transform FTL foods — including produce packers, seafood processors, cheese makers, and deli salad manufacturers — face CTE requirements at the point of transformation or initial packing.
Distributors and Wholesalers
Distributors who ship and receive FTL foods between entities must maintain shipping and receiving CTE records. This is often where supply chain traceability breaks down — distribution operations frequently handle hundreds of products and thousands of lots simultaneously.
Retailers and Food Service
Grocery stores, restaurants, and other retail food establishments that receive FTL foods must maintain receiving records. Restaurants and caterers that also transform FTL ingredients (e.g., making fresh-cut produce or deli salads on-site) face additional CTE requirements.
Key Exemptions
The rule includes several important exemptions. Very small businesses — defined as those with average annual food sales of $1 million or less over the prior three-year period — are exempt from the enhanced traceability recordkeeping requirements. Additionally, farms that sell food directly to consumers (farmers markets, farm stands, CSA programs) are generally exempt for those direct-to-consumer transactions. Certain non-profit food establishments and food produced for personal consumption are also excluded. Note that being exempt from FSMA 204 does not exempt a business from all FSMA requirements — standard recordkeeping rules still apply.
8. How to Prepare Before the Deadline
With the July 2028 enforcement deadline, food businesses have meaningful runway — but the organizations that will be ready are the ones that begin systematic preparation now. Here is a structured approach to building FSMA 204 compliance:
Audit your product catalog against the FTL
The first step is determining which of your products are actually on the FTL. This is not always obvious — fresh-cut versions of commodities, multi-ingredient products containing FTL foods, and products in categories with nuanced definitions (like the hard/soft cheese distinction) require careful analysis. Use our FTL lookup tool for initial screening, and consult your legal and regulatory teams for products on the boundary.
Map your supply chain for each FTL product
For each product on the FTL, document every entity in your supply chain — from the farm or origin supplier to your customers. Identify which CTEs occur at each point and which entity is responsible for creating each record. This supply chain mapping exercise often surfaces gaps and assumptions that need to be resolved well before compliance becomes mandatory.
Engage your trading partners early
FSMA 204 compliance is not something you can achieve unilaterally. The TLC linkage requirement — which requires that your receiving records reference the same TLC as your supplier's shipping records — means that your compliance is directly dependent on your suppliers' compliance. Begin conversations with your key suppliers and customers about how you will exchange traceability information, in what format, and through which systems.
Evaluate traceability software and systems
Paper-based systems are technically compliant but practically untenable given the 24-hour retrieval requirement. Evaluate supply chain traceability platforms, ERP enhancements, and industry-specific traceability tools. Look for solutions that can assign and track TLCs, capture KDEs at each CTE, and generate FDA-ready reports quickly. If you are building compliance software, consider integrating the FoodChain API to automate FTL classification and CTE/KDE requirement lookups.
Implement and test before the deadline
Aim to have your systems operational at least 12 months before the July 2028 deadline. This gives you time to identify recordkeeping gaps, work through supplier compliance issues, and train staff — before you are in a compliance-required state. The FDA has indicated it will conduct compliance verification inspections, and the penalties for non-compliance under FSMA are significant.
Check Your Products Against the FTL — Free
Use the FoodChain FTL Lookup Tool to instantly check whether any food product is on the FDA Food Traceability List. Get the FTL category, applicable Critical Tracking Events, and required Key Data Elements — no account required for the free tool.