Are You FMSA 204 Ready?

Right now, businesses are facing tech overcorrection, logistics pressure, and a whole lot of people suddenly wondering whether their ERP system can actually talk to their warehouse. We’ll break down some of the need-to-know information, how you can get your supply chain ready, and how EDI/API solutions can help.

What Is FSMA 204?

FSMA 204 is part of the Food Safety Modernization Act. It’s the FDA’s rule focused on traceability—making sure that when a food product is identified as contaminated, we can quickly identify where it came from, how it got there, and who handled it.

The rule applies to any business that manufactures, processes, packs, or holds foods on the Food Traceability List (FTL), which leans towards products that often run the risk of recalls: leafy greens, soft cheeses, seafood, melons, and more.

Breaking Down the Alphabet Soup of KDEs and CTEs

Under FSMA 204, companies must collect Key Data Elements (KDEs) at specific Critical Tracking Events (CTEs) throughout the supply chain. What does this mean in simple terms?

Key Data Elements (KDEs) are specific data points of information you must record at each stage of the food supply chain to ensure traceability. These data points include things like:

• Product identifiers and lot codes
• Origin address
• Destination address
• Time the goods were transferred
• Temperature controls (shipping and storage)
• Company name and contact information for any parties that took custody throughout the process

These are a few examples of KDEs. So, if KDEs are solid facts, CTEs answer the “when and where” moments in a food product’s journey—think of them like a more detailed time stamp.

The FDA requires four essential CTEs, so you need to be able to answer four essential “when and where” questions:

• Harvesting – When are/were the food items (FSMA uses the term “agricultural commodities”) removed from their growing location.
• Receiving – When a facility or company receives a product
• Transformation – When a product is changed (think chopping, mixing, cooking, and repackaging)
• Shipping – When are the products sent to another location or customer

You’re On a Deadline

As of January 1, 2028, if the FDA comes knocking? You need to be ready to hand over all that data—in a clean, sortable spreadsheet—within 24 hours.

How to Get Your Supply Chain Ready (Spoiler: It’s More Than Spreadsheets)

This isn’t the law you can tick off boxes for in Q4 years from now. It requires deep thought and analysis about how your data flows across systems and partners.

Here’s what you need to do now:

Map Your CTEs

Depending on your role in the food supply chain, you may need to create a data trail, with key points like where food is harvested, transformed, packed, shipped, or received needing to be documented.

For example, if you supply tuna fillets to a large national grocery store, the traceability requirements would start with the fishery where the boat docks. They’re responsible for the harvest details—what day were the fish caught, where the fish were caught, what kind of fish, the quantity of fish, and what day they arrived at the dock. The fishery then assigns a Traceability Lot Code or TLC.

The next person who needs to keep records is the shipper, in this case, a cold-chain logistics company. They need to record the product, quantity, and lot code, the product’s origin and destination, the shipment date, and important reference documents such as the bill of lading or invoice.

Once the tuna arrives at your factory for processing and distribution, it’s your turn! You would be responsible for logging the lot code and quantity, supplier info, date, and location of when you receive the tuna. Since you’re “transforming the tuna” or cutting it into fillets, you’ll also need to assign a new lot code, record that you cut the tuna into fillets, and the date when you made the fillets. Next, it’s on to the grocery store or the wholesaler.

Once the tuna fillets are ready to go to the grocery store, the large grocery store chain will need to record the lot code, supplier info (so information about your production company), information about the tuna fillets, the number of fillets, and the date the fillets were received. The point is that every time the tuna changes hands or is transformed, the data needs to document it and provide a trail back to the fishery.

Knowing your step in the chain of custody is crucial in determining what information you need to collect, store, share, and retrieve if the FDA requests an audit.

Audit Your Data Sources

Ask yourself the following questions:

• Am I capturing KDEs electronically?
• Is the data consistent?
• If necessary, can I track the product from my step in the food supply chain to the next step?

Automate Your Reporting

You’ll need to generate a report for the FDA with all KDEs, sorted and searchable, in 24 hours. If that sounds like a job for your Excel power user, you’re already in trouble.

The Good News: EDI and API Integrations Are Game Changers

If you’re using EDI (Electronic Data Interchange) or API-based integrations, you’re halfway there. These tools already move much of the data the FDA wants—if you’re using them right.

Work with your EDI provider and partners to specify fields where the new KDE data should be transmitted—such as the lot #, origin address, and any specified data for your specific food product. By adding these fields into your management software and adding this data to your EDI standard requirements, you’ll have the data ready to pull if the FDA comes around with a request.

Here are some of the mission-critical documents you’ll want to evaluate and determine where to insert and communicate these critical data elements:

• Advance Shipping Notice (856) – A detailed record of what’s being shipped, when, and how.
• Warehouse Shipping Order Confirmation (940) – It tells the warehouse: “Go time.” It authorizes a shipment and documents what’s leaving, when, and in what quantity—crucial for outbound traceability.
• Warehouse Shipping Advice (945) – The follow-up to the 940, this one confirms what was shipped—offering verified, final data to back up your shipping KDEs.
• Stock Transfer Shipment Advice (943) – When products move from one facility to another, this document keeps track of what’s moving and when—vital for traceability between owned sites.
• Warehouse Receipt Advice (944) – It confirms that a facility or warehouse received the products, completing the chain of custody and capturing a key receiving CTE.
• Motor Carrier Load Tender (204) – Think of this as your handoff instructions. Used to request shipment from a carrier, it sets up the movement and defines how products will travel—starting the transportation tracking process.
• Shipment Status Message (214) – Your pseudo-GPS. It updates shipment progress—departure, in-transit checkpoints, arrival—so you can map when and where products moved, a must-have for traceability logs.
• Price/Sales Catalog (832) – Think of this as your product reference sheet. While not traceability-specific, it standardizes product IDs, GTINs, and descriptions, so you’re always speaking the same language across your systems and partners.

These are a couple of examples of the critical documents you’ll want to create your digital paper trail.

How Do I Put All These Electronic Documents Together?

This is where data integration solutions come in. EDI documents are the structure of your digital paper trail, while integration is the pipeline that moves these documents between you and your trading partners.

To make it work for FSMA 204, you need a workflow that automatically connects, formats, validates, and routes these documents between your internal systems (like an ERP, WMS, or TMS) and your trading partners.

That’s typically done through an EDI VAN (Value-Added Network) or direct integration using AS2/API connections. A solid EDI partner like Kleinschmidt will help map your FSMA-required KDEs into fields within your standard document workflows and automate the exchange based on each CTE.

If you need to create a database to store everything securely outside of your management system, then when the FDA requests traceability data, a project like this would be well within the managed services framework—with links, searchable, and ready to export.

What If I’m Not Using EDI—Do I Have To?

If you’re not using EDI yet, you’re not alone—but FSMA 204 compliance will add to the list of benefits you could achieve from automation and structured, normalized data that adoption of an EDI-based trading partner data exchange brings. Be sure to ask your EDI partner if they can help you bring paper or digital-paper data into your streamlined workflow to save time and reduce the risk for errors that stem from manual entry, PDFs, spreadsheets, or email chains.

Without structured, automated document exchange, it’s impossible to consistently capture the KDEs required at each step in the food supply chain.

I’m Already Using EDI, I Should Be Fine, Right?

It depends! You’re in a much better position than most.

If you’re already exchanging EDI documents with trading partners, your next step is to verify that your transactions contain the right KDEs and that they are aligned with FSMA 204 requirements.

This may involve enhancing your ASN (EDI 856) to include more detailed lot-level data, adding timestamps to your 945s, or integrating shipment updates (EDI 214) with your traceability log.

You’ll also want to ensure your system can consolidate and export all this data quickly—ideally into the sortable spreadsheet format the FDA now expects within 24 hours.