A cyclospora outbreak will look and operate very differently in the future once Section 204 of the Food Safety Modernization Act (FSMA 204), or the Food Traceability Rule, has been implemented, food safety experts say.
Current investigations take a sequential approach, with regulators working backward through each link of the supply chain, from retailer to distributor to processor to grower, says Andrew Kennedy, chief traceability officer at iFoodDS. Because investigators often rely on manual data entry, phone calls, emails, broad date windows and paper invoices, the traceback process can take weeks and frequently results in wide-net recalls.
“It’s just a massive communication challenge trying to work through these human interactions with all these different points in the supply chain. It’s a scheduling nightmare trying to have all these calls,” he says.
From Blanket Pulls to Surgical Recalls
What would a cyclospora outbreak look like in a post-FSMA 204 world? For one thing, far more precise. Kennedy and Lucy Angarita, director of supply chain optimization of GS1 US, say future recalls and food safety investigations will target specific batches instead of clearing entire store shelves.
Angarita notes that in a post-FSMA 204 world, every supply chain participant captures the necessary critical tracking events (CTEs) and key data elements (KDEs) using a standardized, common language.
“A surgical recall means you can go and target a specific lot code, or two or three, because it could be more than one that’s impacted,” she says. “Instead of doing these blanket recalls, you could say, ‘These were the locations that were affected, and this is the product we’re going to recall.’”
Kennedy agrees, noting that under FSMA 204 rules, regulators can request an electronic sortable spreadsheet within 24 hours. Retailers can instantly provide lot codes, quantities, units of measure, shipping origins, destinations and product descriptions. Now, an investigator can go directly to a processor without needing to go to a distributor.
“That saves two weeks right there just by skipping the distributor step,” he says. “I’m two weeks down the road.”
The Data Backbone: GTINs and GLNs
Kennedy and Angarita say the backbone of FSMA 204 and these surgical recalls includes a move toward globally unique identifiers: the GTIN (Global Trade Item Number) for products and the GLN (Global Location Number) for facilities, ranches and coolers.
“The growing area or the ranch can be identified with a global location number,” Angarita says. “This globally unique identifier points to master data that contains, for example, the food safety contact, the address for that specific ranch, the field name where the greens were harvested from. Then the product is identified with a GTIN, a Global Trade Item Number, and that also has master data associated to it, such as the commodity, the brand owner, etc.”
Kennedy notes that future FDA recall notices will offer granular detail, including the product’s Traceability Lot Code and Traceability Lot Code Source. This visibility is fueled by the industry shift toward 2D barcodes (such as GS1 DataMatrix or QR codes), which can hold vast amounts of data and be printed directly on corrugated packaging. Crucially, 2D barcodes feature built-in error correction, remaining readable even if 20% to 30% of the code is damaged.
2D Barcodes, AI, and Hands-Free Tracking
Looking ahead, Kennedy says the biggest technological leap in the future of traceability is hands-free data capture using computer vision, artificial intelligence, cameras and smart glasses to record tracking events automatically. He says smart glasses with optical character recognition will read the 2D barcode and create these tracking events.
“All that data entry that people used to do, it’s now just like look at this document, look at this label, AI fills in the blanks and completes the event,” he says. “That’s going to lower the cost of data capture to the point where ... scanning cost and all that and printing cost will drop.”
One major bottleneck to FSMA 204 compliance is interoperability, when supply chain partners use proprietary software formats that cannot talk to one another. Open GS1 standards, such as Electronic Product Code Information Services and Advance Ship Notices, resolve this by letting data flow seamlessly from packer to distributor to retailer.
“You don’t have to assign new numbers, new keys; you don’t have to do mapping, you don’t have to do anything,” Angarita
says. “You just scan a barcode, and in a perfect world, it just merges all that information.”
Managing Co-Mingled Produce and Transformations
Traceability becomes even more complex with co-mingled ingredients, such as a bagged salad mix containing greens from multiple farms. Under FSMA 204, processing these blends triggers a “transformation event,” requiring a digital link between incoming farm lot codes and the new finished-product lot code.
“As the FDA looks backward from a single bag at the retail store, investigators can take that lot code back to where the processor has that data of what were the five branches that sent those greens and became that one lot code,” Angarita says. “If we’re looking at a recall forward from that farm lot or the five lots that went into that one lot, where did it go? Which customers received it?”
At the store or restaurant level, GS1 DataMatrix or GS1-128 barcodes on master cases tie incoming shipment data directly to CTE records.
“All the data is connected, and it becomes machine-readable and interoperable,” she says. “The traceability lock code, GTIN and lot code can connect, as well as the Traceability Lot Code Source, which is really where that product was packed, and where it originated.”
And in a surgical recall, Kennedy says this means store and restaurant shelves are stocked.
“This leads to less product waste, less revenue loss, and more consumer trust because the industry can be specific about what is actually impacted,” he says.
Preparing Before the 2028 Deadline
Though the FDA’s official FSMA 204 compliance deadline was extended to July 20, 2028, both Angarita and Kennedy emphasize that produce companies actively establishing supplier data protocols today are setting themselves up for long-term success.
“Those folks are ahead of the game because they’re already starting to talk to their supply chain,” Kennedy says. “You can’t track what isn’t provided to you. ... Some folks just ignored traceability and put it on the back burner, and so they’re going to have to play catch-up a little bit.”
Angarita says compliance will take time. Companies need to start with pilots and see what data needs to be updated to be traceback-ready, but she cautions, “Don’t treat it like it’s a project.”
“Think about it as a broader visibility effort to not just meet regulatory compliance but make your supply chain process and decision-making so much better,” she says. “It’s not just about meeting compliance; it’s about product freshness. With the same data, you know what product is where, you know stock rotation becomes a lot better. Product freshness at the restaurant or retail grocery store is improved.”
Kennedy reminds the produce sector that major outbreaks have historically catalyzed pivotal industry standards, from the Produce Traceability Initiative to FSMA itself.
“I think the cyclospora outbreak is going to be one of those seminal events that really gets things moving,” he says. “I think this is one of those moments that FSMA 204 is kind of on the shelf waiting for something to happen. This is that thing that senior leaders can look at and say, ‘Oh, we absolutely need to do this.’ ... Don’t let a crisis go to waste.”
