FSMA 204 prep should continue despite proposed delay, experts say

When the Food and Drug Administration announced its intent to push back the enforcement of Section 204 of the Food Safety Modernization Act, it was met with relief from many in the produce industry, as the rule establishes additional traceability record-keeping for companies that grow, manufacture, process, pack or hold food on the Food Traceability List.

The FDA says the additional 30-month extension would address concerns the industry had about compliance by the original Jan. 20, 2026, date. Some in the fresh produce industry had said companies were likely going to implement a hybrid of manual and automated processes and a lot of workarounds just to be ready for compliance.

With this additional 30 months, Andrew Kennedy, chief traceability officer of iFoodDS, likened it to a college student cramming for a final, when a massive snowstorm closes the campus down and cancels classes. Kennedy said the last thing that student should do is go skiing all weekend.

Kennedy advises companies to continue to work through implementation now instead of waiting until the compliance date is closer to July 2028.

“I just heard this today from a customer,” Kennedy said. “They said, ‘Yesterday, we thought we were way behind, and we sort of panicked, and we were really worried about being way behind. Today, we feel like that pressure is lifted, but we don't want to be in that situation yet. We don't want that panic feeling, because we got close to the deadline and realized, ‘Oh, we're not ready.’”

Angela Nardone, chief operating officer at Share-ify, said while 30 months might seem like a long time, for a produce industry business implementing enterprise resource planning software, 30 months is about the right amount of time to implement new software and practices.

“The reason to start early is the testing, because FSMA 204 is about interoperability,” she said. “That’s what all companies are working on right now. If we hadn't changed the timeline, they'd all be working on setting up their systems. No company is testing interoperability right now.”

Nardone says it’s the interoperability — the passing of the data along the life cycle of fresh produce — that will likely have kinks that need to be worked out by the industry.

“A common thing we see is that people are receiving and shipping and whatnot, and they don't think about creating labels in the event that they need to assign a lot number,” Nardone said.

Angela Fernandez, senior vice president of market development for GS1 US said this time is ideal for those in the fresh produce industry to do pilot testing to ensure capabilities are working.

“We have more time to pilot and make sure that we've captured [the data] the right the right way, that we're sending it the right way, and it's complete, and it's clean and it can be utilized down the supply chain,” she said.

And it’s important to understand exactly why this rule was created, says Fernandez, who notes FSMA 204 will help track products down more efficiently.

“[Currently] when we have an outbreak and the FDA does the investigation, they have a hard time tracking the records together, and sometimes they're not digital,” she said. “It depends on who that supply chain partner is and what size they are and what their capabilities are. So, when we're looking at certain commodities, it is very hard to get down to the actual producer of those commodities or even what that lot production was.”

Kennedy said this is an opportunity to use iFoodDS’s “Learn, Plan, Do” review methodology to help companies understand how compliance will work.

“Instead of having a lot of work-arounds and manual operations and just kind of a cobbled together plan, [ask] ‘How can I make it something sustainable that I can do every day, all day, and it doesn't interrupt my operations and doesn't end up costing me more in the long run,'” he said.

Kennedy suggests those with products that fall under FSMA 204 should test interfaces with customers and suppliers.

“Use that time for testing those interfaces, because the human component, the communication between people, always takes the longest,” he said. “Get on those connections and smoothing out the interfaces and automating your process and really make it something that will benefit your organization by having all this information digitized so you can speed recalls and outbreak investigations happen all the time anyway.”

Fernandez said that while retailers had originally asked for compliance earlier than Jan. 20, 2026, she anticipates that some retailers may still want compliance earlier. Specific commodities and trading partners should expect things to continue to move toward FSMA 204 compliance.

Kennedy said those who fall under FSMA 204 will see less of a tolerance by the FDA for estimated lot codes, as many produce industry businesses considered implementing to get in compliance by Jan. 20, 2026.

“Now that the industry has three more years to get there, there's probably going to be less tolerance when we get to the deadline for not being able to produce the traceability lot code,” he said.

And technology will likely play a huge part in the future, Kennedy said. As retailers and produce industry suppliers add 2D bar codes, the bar codes could benefit the fresh produce industry in its compliance of FSMA 204. He said 2D bar codes could feature a product ID, the GTIN, lot code, best-by date, pack date, harvest date or more.

“The other interesting thing I found out about these 2D bar codes is there's error correction built into them so that they're more reliable for scanning,” Kennedy said. “And it's not just a little more reliable, it's exponentially more reliable. With a bar code, like the QR code, they can have up to 30% in that bar code. So, even if it's a little damaged in one section, there's enough error correction it can fill in the blanks in the bar code.”

Nardone said she worries that smaller companies, likely needing the most help to meet compliance, will view this as a respite instead of more time to prepare.

“This is essentially the FDA saying, ‘You need to get started. We're giving you this time so that you're ready to go,” Nardone said. “Hopefully people use this time wisely.