This article was updated on March 26, 2026 to reflect current FSMA 204 requirements.
When the FDA finalized the Food Traceability Rule, it changed the recordkeeping obligations for a significant portion of the food industry. Anyone who manufactures, processes, packs, or holds goods on the Food Traceability List now have specific requirements to meet, and those requirements go well beyond keeping better spreadsheets.
The rule requires food businesses to capture defined data at key points in the supply chain and to make those records available within 24 hours, or as otherwise approved by the FDA. In some instances, businesses must also be able to provide that information in an electronic sortable spreadsheet.
If your company has disconnected systems and manual processes, this is difficult to do reliably.
What Is the FSMA 204?
FSMA 204 refers to Section 204 of the Food Safety Modernization Act, which specifically outlines the rules and revisions produced by the FDA. The rule is designed to make foodborne illness outbreaks faster to investigate and faster to resolve. The FDA’s position is that contaminated product stays on shelves too long because the data needed to identify and locate it isn’t consistent, connected, or quickly accessible.
The fix from the FDA’s perspective, is standardization. The rule establishes what information food businesses must capture, at what point in the supply chain, and in what format. When there is a suspected contamination, the FDA needs to be able to pull that information quickly and act on it without chasing records across disparate systems.
What is the FSMA 204 compliance date?
While original compliance date was January 20, 2026, the FDA and Congress have revised the rule to extend the date of enforcement to July 20, 2028.
The extension gives your company more time to comply with the FDA, but major retailers are already changing their requirements. There is no time to wait.
The FDA has encouraged companies to use this time to identify which products are covered, which Critical Tracking Events apply to their operation, and what data they are already capturing. Most importantly, companies need to plan for how they will exchange this information with partners.
These assessments take time, and companies that use this window to modernize their supply chain data infrastructure will be ready when enforcement arrives.
Why act now?
At least one major retailer is already moving ahead of the FDA timeline. Walmart now expects all food suppliers to provide an ASN containing KDEs for food shipments, with SSCC-18 pallet labels linked to the ASN and GS1-128 case labels. Those requirements took effect August 1, 2025.
Who does FSMA 204 apply to, and what is the Food Traceability List?
The rule applies to businesses that manufacture, process, pack, or hold foods on FDA’s Food Traceability List.
The Food Traceability List, or FTL, identifies the foods subject to the additional recordkeeping requirements in FSMA 204.
The list includes foods the FDA considers higher risk, such as fresh leafy greens, fresh-cut produce, shell eggs, nut butters, soft cheeses, and certain seafood. Foods that contain a listed ingredient are also in scope, as long as that ingredient is still in the same form it appears on the list.
Scoping is the right first step. Before a business can plan its compliance approach, it needs to know which products are covered, where they move through its operations, and which internal systems already hold pieces of the required data. Many food businesses going through this exercise discover that the data exists, it’s just living in the wrong places.
Where EDI fits into FSMA 204 Readiness
EDI isn’t a complete compliance solution on its own, but it’s directly relevant to the shipping CTE, which is where many food suppliers need to focus first.
GS1 US has published guidance showing how the X12 EDI 856 Advance Ship Notice can help support the Shipping Critical Tracking Event requirements under FSMA 204. Most food suppliers are already generating 856s for their retail customers.
For many food businesses, accurate lot data still has to be pulled from one system and matched to shipment data in another before it reaches the ASN. TrueCommerce connects EDI with your ERP and warehouse systems that hold that data, so the ASN reflects what actually shipped. That gives suppliers a more reliable way to meet retailer requirements and respond to traceability requests without chasing records by hand.
Integration between those systems is what makes accurate, timely traceability data possible at scale. That’s also what makes the rest of supply chain operations run better. Businesses that build this infrastructure for FSMA 204 compliance tend to find that they’re also getting better fill rates, fewer out-of-stocks, and faster order cycles as a result. The compliance work and the supply chain improvement work are often the same work.
What does FSMA Require?
The rule is organized around two concepts: Critical Tracking Events and Key Data Elements.
Critical Tracking Events (CTE) are the specific points in the supply chain where records must be created. There are seven CTEs, ranging from harvesting and initial packing through shipping and receiving. A business’s obligations depend on which CTEs actually occur within its operation. A distributor that receives and ships food is responsible for the receiving and shipping events. A produce grower who also packs is responsible for different ones entirely.
Key Data Elements are the specific pieces of information that must be recorded at each event. They vary depending on where you sit in the supply chain. At shipping, for example, the rule requires the traceability lot code, product description, quantity, the receiving location, and the shipment date. Making sure the right data is captured at the right moment, and that it stays connected as it moves through different systems and partners is a challenge.
What are the seven CTEs?
- Harvesting
- Cooling before initial packing
- Initial packing
- First land-based receiving from a fishing vessel
- Shipping
- Receiving
- Transformation
Not every business is involved in all seven. A useful first step is mapping which events occur in your operation and focusing on compliance planning there.
What is a traceability lot code?
A traceability lot code is the unique identifier that links a batch of food to its traceability records. FDA requires one to be assigned at specific origination points: when a company initially packs a covered raw agricultural commodity, when it receives seafood directly from a fishing vessel, or when it transforms a covered food into something different.
Once assigned, that code stays with the food. Businesses, generally, should not assign a new one during subsequent steps. Every record created at every Critical Tracking Event must reference the original lot code. That’s what makes it possible to trace a product back through the chain quickly. If the lot code gets dropped, reassigned, or applied inconsistently somewhere in the middle, the traceability record breaks as well as any attempt to respond quickly to an FDA inquiry.
The 24-hour Requirement
When FDA makes a request for traceability records, those records must be available within 24 hours, or within a timeframe FDA agrees to. In the event of an outbreak or recall, businesses must also be able to produce an electronic sortable spreadsheet with the relevant traceability data on demand. For companies relying on paper records or systems that weren’t designed to export cleanly under pressure, that’s a real operational problem that doesn’t have a quick manual solution.
The rule also requires a written traceability plan describing how records are maintained, how covered foods are identified within the business, how lot codes are assigned, and who the designated FDA contact is.
Why the Walmart timeline matters more right now
Even though the enforcement deadline has not yet begun, for most food suppliers, the challenge of FSMA 204 readiness comes from retailers.
As of August 1, 2025, Walmart requires all food and beverage suppliers to submit an ASN containing KDEs for every shipment. Pallets need a specific SSCC-18 barcode tied to that ASN. Cases need a GS1-128 barcode. Suppliers who haven’t built these capabilities are already out of compliance with their largest retail customer, regardless of where FDA enforcement stands.
The chargebacks are happening now. The vendor scorecard hits are happening now. Fixing this problem now maintains relationships with some of your most important retail customers and starts recovering margin that’s been lost to avoidable errors.
Learn how TrueCommerce helps food and beverage suppliers meet retailer compliance requirements without the manual work.
How TrueCommerce supports food and beverage traceability
TrueCommerce’s EDI platform connects directly with the ERP and warehouse systems food businesses already use, so traceability data flows into outbound documents automatically. TrueCommerce handles the grocery retailer workflows that come with the strictest compliance expectations across a network of more than 180,000 pre-connected trading partners, including Walmart, Kroger, Whole Foods, and Sysco.
For businesses that don’t want to manage EDI internally, TrueCommerce’s managed service handles the mapping, maintenance, and ongoing compliance updates that keep ASNs accurate as retailer specifications change. For businesses looking at the broader picture, TrueCommerce’s supply chain platform extends into demand forecasting and inventory visibility, so the data infrastructure built for traceability compliance also supports replenishment decisions, shelf life management, and the kind of supply chain visibility that helps food businesses grow into new retail accounts.
Explore TrueCommerce’s food and beverage supply chain solutions.
Ready to get ahead of this?
Whether you’ve just received a compliance notice from a retail buyer or you’re proactively assessing your FSMA 204 readiness, the conversation usually starts in the same place: understanding where your traceability data lives today and what it would take to connect it. Book a demo and we’ll walk through what that looks like for your specific operation.
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