5 Tricky Spots to Tackle for FSMA 204 Compliance
Written by: Neil Aeschliman
Good news! You have over 1,000 days left to be ready for the FDA’s Food Traceability Final Rule, aka FSMA 204 deadline. Now is the time to take stock of what is needed. Start by comparing the foods on the Food Traceability List (FTL) with the foods your company works with. Then, check out whether the exceptions apply to some of your processes or supply chain segments. Following these two steps will help get your arms around FSMA 204 compliance requirements.
From there, the rule might seem kind of straightforward. You need records of the activities your company performs related to each food covered by the FTL. Records like where the food came from, where it went, when did this happen, which ingredients became this new food, etc. But you want to watch out for some gotchas.
We compiled 5 tricky spots to tackle to ensure you have FSMA 204 compliance by January 20, 2026.
TRICKY SPOT #1 – Lot numbers on the package but missing from our records.
The new rule requires records of Critical Tracking Events to be tied to lot numbers, called the Traceability Lot Code (TLC) in the rule. We’re used to lot numbers in the food industry. They’re printed on the bottom of our products and sometimes in labels on the containers moving through the warehouse. But do we receive the lot number from our suppliers? An ASN can include a Lot number but do ours? What about the ones we receive? What will it take to start including lot numbers? Are they stored in the systems we use to manage our business (e.g., ERP, WMS)?
And while we’re on the topic, did you know that a TLC can only be assigned at certain points in the lifecycle of a food? When food is initially packed, transformed, or the first land-based receiving is performed. That means all the companies in the business of distributing foods need to record the lot numbers of the food they receive and then be able to report which lot numbers they sent out.
TRICKY SPOT #2 – You know your supplier… but do you know where the TLC was assigned?
You know your supplier. You’ve had a relationship for years and they have been supplying high-quality foods, consistently throughout that time. But is your supplier the one assigning the TLC? In addition to sharing the TLC down the supply chain, the rule also requires companies to share the locations where a TLC was assigned. That means if the food you received from your supplier was transformed or initially packed by another location besides your supplier, you need to get that info from your supplier, too.
Is this information you already ask for? How can you receive it?
Now, some companies may be worried about this aspect of the rule. Will this disclose supply relationships you would rather keep private? Well, there is good news. The FDA offers an alternative method for providing the FDA with data about the location where the TLC was assigned. This is called the Traceability Lot Code source reference.
TRICKY SPOT #3 – Who defined the product? What about the location? How is the info shared?
You know the product. It’s identified by a Global Trade Item Number™ (GTIN®), or your trading partner’s internal SKU number. And your trading partners know to send the product, here, to DC #8013. But the FDA doesn’t know those numbers. That’s why the rule asks for descriptions of the food products and locations in your traceability records. Easy enough when it’s your products and your locations but what happens when it’s the products of your supplier or of your supplier’s supplier? Same with locations.
While you may know the products and locations of your traceability records, make sure you have reliable channels for the data which describes them.
TRICKY SPOT #4 – Recording activities on the days they happen not the date they’re added to the accounting ledger.
You’ve seen it happen. The truck arrived Tuesday but so did seven others so is it a big deal if it didn’t get entered into the system until Wednesday night? What’s the harm? It got entered, right? The new rule emphasizes not only the What and Where of traceability but also the When.
Companies need processes to record the timeline of when activities actually occurred not when they reported them. This brings us to our last tricky spot…
TRICKY SPOT #5 – Visibility happens at cruising speeds not while taxiing.
Food needs to move fast. Stalks of celery harvested in California on Monday are on shelves in Pittsburgh before the weekend. Food stays in motion from harvest to plate to preserve freshness for consumers. Dozens of little steps need to go right for food to make those timely journeys. FSMA 204 may require a simple spreadsheet of data but recording this data for our complex food web requires recording data in real time.
To record visibility in real-time, you need a technology partner who keeps pace with the speed of your business. That’s where Real Time Intelligence’s eP360 comes in.
See how eP360 can help retailers and suppliers in the food industry meet these FDA food safety regulations and more. Schedule a demo today!