Food Traceability, FSMA Ruling, and the Impact on Suppliers

In this article, learn about:  

• What food traceability is  

• What FSMA 204 is (the Food Traceability Rule)  

• The Food Traceability List  

• The core building blocks: CTEs, KDEs, and the Traceability Lot Code (TLC)  

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It is easy to leave room for errors and delays when shipping food from growers to packers, all the way to distributors and stores. Food traceability closes those gaps between each stage by making it possible to follow a product and its key attributes from origin to the shelf. 

Traceability has existed in the supply chain for many years. What’s changing is the push toward consistent data across hand-offs, rather than a patchwork of paper logs, emails, and spreadsheets. That’s the aim of FSMA 204—the FDA’s Food Traceability Rule —to standardize the “what, when, and how” of traceability for a defined set of higher risk foods, without prescribing a specific technology. 

What is Food Traceability? 

Food traceability is the ability to identify where a food came from, who handled it, and which lot it belongs to at each step in the supply chain. Strong traceability matters because it: 

• Speeds investigations: regulators and trading partners can pinpoint affected lots quickly. 

• Shrinks recalls: fewer cases are pulled, which protects sales and brand trust. 

• Improves accuracy: clear lot linkages reduce disputes about what was shipped, where it was shipped, and when it was shipped. 

• Reduces waste: targeted removals prevent unnecessary destruction of good inventory. 

Related Reading: What Do I Do When My Product Has a Recall? 

The Food Traceability List (FTL) 

The Food Traceability List spells out which foods must follow FSMA 204’s additional recordkeeping rules. It is essentially a “watch closely” list of foods that require extra tracking due to it being higher risk, such as:  

• Leafy greens 

• Certain cheeses 

• Specific seafood 

• Shell eggs 

• Fresh cut fruits and vegetables  

Extra tracking assigns each batch, or “lot,” a unique code similar to a package tracking number. When a problem arises, the affected units can be quickly identified and removed.  

The list mainly applies to the foods named above, but it can also extend to products that use those foods as ingredients as long as the ingredient remains in the same form. For example, fresh tomatoes in refrigerated salsa or fresh cut fruit in a parfait would be covered and need that extra tracking. If, on the other hand, the tomatoes have been cooked in a shelf stable sauce, it would not be considered in the same state and therefore would not be covered. 

What is FSMA 204 (the Food Traceability Rule)? 

The Food Safety Modernization Act (FSMA) is a U.S. law, enacted in 2011, that shifted the FDA’s approach from reacting to contamination to preventing it.  As a result, FSMA created a suite of rules—Preventive Controls for Human/Animal Food, Produce Safety, Sanitary Transportation, Foreign Supplier Verification (FSVP), Intentional Adulteration, and more—along with stronger inspections and recall authority.  

FSMA Section 204 builds on that prevention-first model by requiring standardized traceability recordkeeping for certain higher-risk foods so that, as mentioned above, investigations move faster and recalls can be narrower and more targeted. It doesn’t change how food is produced; it clarifies which data must follow the product and when that data must be captured. 

CTEs, KDEs, and the Traceability Lot Code (TLC) 

How FSMA 204 works, in simple terms:  

• For starters, the rule focuses on Critical Tracking Events (CTEs), which are the main points where a product changes ‘hands’ or changes form. Common CTEs include growing, initial packing, first land-based receiving (applicable to certain seafood), shipping, receiving, or transformation (such as chopping, mixing or cooking that results in a new product).  

• At each CTE, companies must record Key Data Elements (KDEs). These are the basic who, what, when, and where details — things like product identity, locations, dates, and quantities. The specific KDEs required will depend on the type of CTE.  

• A Traceability Lot Code (TLC) connects those KDEs throughout the supply chain. TLCs are usually assigned at the point of initial packing or during transformation. If a product is transformed or combined with others, the new output would receive its own TLC that still links to all the original inputs.   

If an investigation were to take place on a specific product, companies covered under FSMA 204 would have to provide all these records in an electronic, sortable format (like a CSV file). This allows regulators to quickly filter by TLC, date, or location, without needing to re-enter data manually. 

For example: 

Fresh tomatoes harvested from Block A are initially packed and assigned TLC T-001. A processor receives T-001, dices the tomatoes with onions (TLC O-009) to make Pico de Gallo, and transforms the mixture into finished goods under new TLC P-147. KDEs at each CTE (who/what/when/where, quantities) plus the TLC linkages (P-147 → T-001 and O-009) enable swift, targeted traceback if an issue arises. 

How Suppliers Can Be FSMA Compliant  

When it comes to implementing  FSMA 204, a.k.a the Food Traceability Rule, it’s important to note that the rule is technology-neutral. Companies are not required to use barcode symbologies, software, nor specific label formats; those are business choices. As long as the required data is accurate, linked, and retrievable; companies are compliant. Many firms adopt GS1 barcodes or 2D labels for practicality, but the regulation doesn’t prescribe a specific system. 

General Supplier Requirements 

For starters, suppliers should have a written traceability plan describing TLC assignment, CTEs performed, KDE capture methods, locations, record formats/systems, roles, and training. They should also have Operational documents (ASNs, BOLs, invoices, case labels) that carry the TLC for in-scope items so downstream partners can record it at their CTEs. Aswell as the capability to export required data quickly as an electronic, sortable file when FDA asks. 

Best Practices When Implementing FSMA 204 

A solid traceability plan does two things well: it makes lot-level data easy to capture in real time and easy to retrieve on short notice. The aim isn’t more paperwork; it’s fewer blind spots when product moves between fields, plants, warehouses, and stores. The following practices outline how teams can organize people, data, and documents so FSMA 204 requirements fit naturally into day-to-day operations. 

Define a Clear TLC Policy  

The Traceability Lot Code (TLC) is the thread that ties everything together. Leading plans specify where the TLC is created (typically at initial packing or transformation), how it is formatted (e.g., date-site-line-sequence), and how long codes remain unique. When transformation occurs—mixing, chopping, cooking—outputs receive a new TLC and records retain links to all input TLCs.  

A short failure rule helps: if a covered shipment leaves without a TLC on the paperwork, the process stops until corrected. 

Map Events and Data by Location 

FSMA 204 is event-based, so plans work best when they describe which Critical Tracking Events (CTEs) each site performs—growing, initial packing, first land-based receiving (for seafood), receiving, shipping, and transformation—and which Key Data Elements (KDEs) are captured at each event. The plan should name the system of record (ERP, WMS, PLM), how the data is captured (scan, form, EDI), and who owns data quality.  

Put the TLC on Labels and Business Documents 

Traceability fails when lot codes live only in batch logs. Best practice is to make the TLC visible on case and pallet labels and to carry it on operational documents—ASN, BOL, invoice, pick lists—for covered items.  

Many teams standardize GS1-128 or 2D barcodes to encode GTIN, lot, and dates for scanning. The regulation is tech-neutral, but consistent labeling eliminates transcription errors and speeds receiving. 

Related Reading: The Future is 2D Barcodes 

Ensure Partner Handoffs  

Every handoff is a risk point. Plans should list all nodes that touch covered items—growers, packers, importers, co-mans, brokers, DCs/3PLs, retailers/foodservice—and specify which CTEs each partner performs and which KDEs must be exchanged.  

Contract language and routing guides can require TLC presence and data completeness, with a short SLA for fixing EDI or labeling errors. Reverse flows (returns, salvage, donation) deserve equal attention, so the chain remains intact in both directions. 

Train the Roles That Touch the Product 

Training works best when it is role-based and brief. Receiving teams learn to verify TLC presence and capture KDEs on receipt; shipping teams learn to confirm TLC on documents before goods leave; production teams practice recording inputs, outputs, and the new TLC at transformation. Job aids posted at the scanner or line outperform long slide decks. Refresher sessions tied to seasonality or staff turnover keep quality steady. 

Test the System with a Small Pilot, Then Scale 

A plan on paper is a starting point; a mock traceback is the proof. Select one covered product family and follow a finished-goods lot backward to inputs and forward to customers, using only system exports and documents—not manual notes.  

Gaps found in labeling, EDI, or WIP controls are logged and fixed quickly. Once one flow works smoothly, the approach scales to the rest of the portfolio with minimal rework. 

Monitor a Few Metrics That Actually Predict Success 

Too many metrics create noise. Programs that perform well tend to watch three: the percentage of covered shipments with a TLC on the ASN/BOL/invoice, the percentage of receipts where TLC is captured accurately, and the time to produce the electronic file on request. A quarterly internal audit samples shipments, receipts, and one transformation batch to validate that linkages hold under normal workload. 

Prepare for Trouble Spots 

Traceability often fails in predictable places: commingling without recording all inputs, relabeling that drops the TLC, split cases that lose context, or brokered loads where documents omit the lot. The plan should call these out explicitly and describe the control—new TLC at transformation with input links, no relabeling without reprinting the TLC, case-level scan at split, partner templates that require lot on every document. 

Glossary for FSMA 204 & Traceability  

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