Key takeaways
- FSMA 204 makes fast, detailed traceability essential. Food and beverage businesses need connected data on critical tracking events (CTEs) and key data elements (KDEs) to respond to FDA traceability requests within the required 24-hour window.
- Disconnected systems and manual records create compliance and business risk. Spreadsheets, paper logs and siloed systems can make it difficult to pinpoint impacted products or raw materials, potentially expanding recalls, quarantines and production losses.
- Connecting supplier, production, lot, warehouse and distribution data through an ERP or consolidated data layer can make bidirectional traceability significantly faster and more reliable.
- With the compliance date extended to July 20, 2028, food and agricultural businesses can use a gap assessment to identify weaknesses in their current people, processes and technology, then right-size improvements such as tagging, scanning and automated monitoring.
FSMA 204 compliance requires food and beverage businesses to be able to trace their products from an origination point to the shelf. The most challenging part? You’ve got 24 hours to do it.
If you ever need to trace ingredients from their source to the consumer purchase to satisfy FDA requirements, high-quality, accessible data will be key. Keep reading to learn how your business can implement a data infrastructure that can simplify FSMA 204 compliance.
What is FSMA 204?
The FDA’s Food Safety Modernization Act Section 204, commonly called FSMA 204, requires food producers and processors to maintain detailed traceability records for foods on the FDA’s Food Traceability List. Examples of items on the list include produce, eggs, seafood, cheese and other high-risk food categories.
The rule was originally set to go into effect in January 2026, but was extended until July 20, 2028.
The regulation is built around two core concepts:
Critical tracking events: CTEs are the specific supply chain moments the FDA requires you to document — harvesting, cooling, packing, shipping, receiving and more. Every time a food product changes hands or state, that’s a CTE that needs to be documented.
Key data elements: KDEs are the specific data points that must be captured at each CTE. Who handled it, when, where, under what conditions and with what lot code. No KDEs means no traceability. No traceability means no compliance.
When the FDA tests your readiness, they expect you to be able to pull complete KDE records for selected products across every CTE in the chain in under 24 hours. If you can’t do it, your data infrastructure isn’t ready.
What traceability data does FSMA 204 require?
The rule doesn’t just ask where an ingredient came from. It demands full visibility of every step before and after it enters your possession.
You’ll need records covering:
- Source information: Where raw material originated (field for produce, container for fish/seafood products). More specific data, such as field plots and soil data, isn’t required but can be beneficial.
- Key dates: Dates are needed for harvesting, packaging, shipping and receiving.
- Storage and temperature conditions: Proof that cold chain requirements were maintained throughout transit.
- Lot and sub-lot codes: The unique identifiers that connect data across every system.
- Current product location: Whether it’s on your shelf, in transit, at a 3PL or with an end customer.
Material application data, such as fertilizers, nutrients or treatments applied to crops, is not required under FSMA 204, but as a best practice, businesses should keep these records. It’s also best to keep track of processing steps like washing, grading and sorting events.
Here’s a scenario a juice producer could encounter: The organic celery going into a product had a nutrient applied to it that was labeled organic but wasn’t. Under FSMA 204, you need to know immediately which field plots were affected, which processing batches touched that celery, which bottles were filled and where every single one of them is right now. That’s a hard question to answer without the data being readily available.
How can businesses meet FSMA 204 requirements?
Hitting the 24-hour window takes connected, disciplined data. Here are some steps your business can take to build the necessary infrastructure:
Start with accurate product, lot and supplier data
Most food producers already track their ingredients. The difference is whether that data can be quickly accessed and reconciled. Often, it’s a mix of digital systems and physical records like spreadsheets, paper manifests and handwritten logs. That combination causes the delays.
The goal is tracking ingredients at their source. That means tagging individual plants or field plots, recording every nutrient and material applied at the lot level, capturing labor and material costs through each growth stage and keeping clean records all the way through processing.
Use an ERP as the unifying hub
An ERP system brings together sales, purchasing, production and distribution data in one place. For FSMA 204, the ERP ties lot codes to transactions, what came in, what was processed and where it went. When everything flows through a unified system, a traceability report takes minutes instead of days.
Add a data layer when needed
A single ERP isn’t the best solution for every company. Large-scale agricultural processors often use specialized field-tracking tools from ag-specific vendors. High-volume warehousing systems may exist entirely outside the ERP.
When that’s the case, a data consolidation layer, like Microsoft Azure, can sit above all those systems and unify the data using lot codes as the common identifier. The outcome is the same: a single, bidirectional traceability report when you need it.
Build strong data governance practices
This is where many organizations fall short. Data governance isn’t just a technology issue. It’s a discipline issue.
If individual field plots aren’t tagged, a small contamination event can expose your entire harvest. If production-line QA checks aren’t logged before every operation, a single compromised fill spout can cost you a full day of production instead of a single batch.
The discipline to document and monitor critical control points (CCPs) at every step is what separates a contained incident from a major loss. Volume scanning, such as barcodes, inline readers and lot code scanners, makes that discipline scalable and significantly less prone to human error.
What are the common challenges to FSMA 204 compliance?
Here are some common hurdles businesses encounter in their compliance efforts:
- Pre- and post-facility gaps: Most organizations have solid records within their facilities. What happens in the field before arrival or on a truck after departure is often poorly documented.
- Partner You can control your own systems, but not your suppliers. If an issue originates upstream, you’re dependent on their data and their notification speed.
- Transit conditions: If a refrigeration unit fails during transport and you don’t own the truck, getting temperature logs to prove your product was — or wasn’t — compromised can cost valuable time.
- Data transferability: FSMA 204 requires data to move across organizational boundaries. Your traceability systems need to receive and share structured data with partners, not just track data internally.
What are the risks of disconnected systems and manual processes?
When you can’t trace precisely, you’re forced to assume the worst. Can’t confirm which field plots were affected? Quarantine the entire harvest. Can’t narrow down the production window? Lose the whole day’s output. At high volume, that can mean hundreds of shipments are unnecessarily recalled or quarantined because the data wasn’t specific enough to pinpoint the issue.
Historically, organizations with fragmented systems have seen traceability response times stretch for days or even weeks. Under FSMA 204, that’s not a viable path. Noncompliance can result in fines, mandatory corrective action plans and even temporary shutdowns.
The cannabis industry addressed this problem years ago. Because of strict seed-to-sale compliance requirements in states like Colorado and California, cannabis producers built integrated traceability systems that combined agricultural tracking, production, warehousing and ERP into one unified data environment. That same approach is now the model food producers need to follow.
What steps should food and ag producers take now?
You have time before the 2028 deadline, but don’t procrastinate. Here are some actions to take to help ensure you’re ready to meet the requirements:
Don’t build from scratch. Hire someone who’s done this before.
These systems took years and millions of dollars to develop the first time around. Trying to recreate that on your own is a potential money pit filled with delays. When you need a new piece of equipment, you buy it. You don’t build it. The same applies here.
Start with a gap assessment
Before investing in technology, understand where you are today. A process gap assessment maps your current traceability practices against what FSMA 204 requires and identifies exactly what changes are needed with your people, processes and technology.
Right-size your FSMA 204 solution
Not every operation needs full automation on day one. Smaller-scale operations can use point-in-time solutions and AI-assisted tools to add speed and structure to data they’re already capturing.
Higher-volume operations should plan for tagging, scanning, inline production monitoring and more structured QA processes at every CCP.
Either way, the first step is the same: bring in someone who understands food traceability compliance and can keep you from wasting time chasing your tail.
Read more
Wipfli has built food and agricultural traceability systems from the ground up, including recall packages deployed in high-compliance production environments. We know the nuances. Our team will evaluate the systems and processes you have in place today and help you implement the changes needed to be in compliance by the 2028 deadline. Develop your FSMA 204 plan.