Lack of understanding remains a key issue in FSMA 204 readiness

In 2022, food recalls by the Food and Drug Administration hit a 10-year high, with 416.9 million units recalled. That was a more than 700% jump from 2021 to 2022, according to the FDA.

This is why the FDA created the Food Safety Modernization Act, says Liz Sertl, senior director of supply chain visibility for the not-for-profit standards organization GS1 US.

“FDA with [the] Food Safety Modernization Act is trying to get ahead of recalls so that they can more quickly and precisely get food out of the supply chain when there’s a problem,” she said.

Within FSMA, Section 204 — the Food Traceability Final Rule — requires those in the produce industry to store information and track food differently. Sertl said there is a lack of awareness in the produce industry about FSMA 204, which goes into effect January 2026.

“There are a lot of foods on the food traceability list — it’s not just produce — but produce is the one that tends to be called out much more because of the food safety impacts that we’ve seen historically,” she said. “There is a complexity to it because a carrot in and of itself is not identified on the food traceability list, but a cut carrot is identified as a high-risk food on the food traceability list. Ingredients are counted.”

Sertl says an example of where ingredients would now need tracing is a deli salad containing chopped tomatoes, carrots and lettuce. In the past, a deli salad wasn’t something the produce industry tracked, but now it falls under FSMA 204. She says this is necessary to recognize where the ingredients came from.

Sertl says there is a lack of understanding surrounding FSMA 204 based on the rule’s intricacy and the products that fall under it and those that may not.

“Then there are complexities about who in the supply chain has to track what. The critical tracking events [that need documenting] are things that happened in the supply chain today,” she said. “There’s harvesting, there’s processing, there’s receiving and shipping. There are critical tracking events that happen at restaurants and retail. But all of those things are now called different terms, and that can be confusing to the supply chain.”

Sertl says key data elements — a part of FSMA 204 tracking — may be a new term for something many in the produce industry already track: a date, a time and a place that something happened along the life of the produce.

Understand responsibilities

Sertl says a way to start alleviating some of the confusion and misconceptions around FSMA 204 is to understand the rules and where a produce company manufactures, processes, packs or holds foods on that list. This conversation internally needs to go beyond a food safety team to include corporate leadership, the company’s supply chain partners, IT and more.

“This has to be an organizational discussion,” she said. “From a food safety perspective, this is a much more broad conversation now.”

The collaborative conversation needs to expand to suppliers throughout the supply chain to help understand how other companies plan to comply with FSMA 204, she added.

While it might seem easier to add a piece of technology to speed up FSMA compliance, understanding the company’s responsibility first is the critical step, Sertl says. GS1 US, the Produce Traceability Initiative and other organizations offer guidance to help companies understand compliance.

From there, Sertl says, companies in the produce industry should assess what the company already tracks. Many use GS1 US standards, which identifies critical tracking events and key data elements. Bar codes at POS, QR codes and Produce Traceability Initiative harmonized labels all log critical tracking events, too. Companies can incorporate that data into FSMA 204 compliance, she says.

“Leverage this baseline that you already have invested in to help that FSMA compliance move forward,” Sertl said. “It’s taking these pieces and parts that exist in the supply chain and putting this FSMA 204 compliance puzzle together to help move the initiative forward.”

This takes time

Sertl says she recently attended a seafood industry meeting. The group initiated a mock FDA recall with some trading partners, which they thought would be good practice and something the event could enact quickly.

“While they thought it was going to be super easy, like a day back and forth with emails and spreadsheets, it was much longer” before the group completed the final recall, Sertl said.

Adding to the complexity of compliance are individual retailer requirements. Kroger recently announced it would require traceability with GS1 Standards for all foods, not just those on the FSMA 204 traceability list, with compliance as of June 2025, which is ahead of FSMA 204’s date.  

Sertl says while compliance seems daunting, the produce industry can also see a return on investment with the time and effort needed to meet FSMA 204 standards.

“You have to do it, so there’s the why, but what other pieces can you get from an ROI beyond just checking the box for compliance?” she said.

Armed with traceability data, companies can learn how to mitigate food waste, better manage inventory and engage with consumers. Sertl says she thinks companies will be able to assess the data tracked in FSMA 204 to create and develop better internal efficiencies.

The other element, she says, is the ultimate goal of FSMA 204: to enact a “surgical” recall quickly, thoroughly and efficiently and to accurately pinpoint the source without wasting food unnecessarily.

“You’ll have this information within 24 hours — at least that’s the goal,” Sertl said. “Everybody’s a little bit safer.”

As consumers demand more transparency from retailers and suppliers, the produce industry can leverage the traceability data required in FSMA 204 to respond quickly.

“There’s a brand benefit,” Sertl said. “If I’m a grocery store and I’m much more quickly able to get that specific food off the shelf, I’m better serving consumers from a food safety perspective.”