Are you FSMA 204 ready?
HOLLYWOOD, Fla. — With time ticking down until the Jan. 20, 2026, compliance deadline for the Food Traceability Final Rule, leading traceability experts offered insight on understanding and implementing the rule during a recent panel discussion at the Global Organic Produce Expo 2024.
The rule, part of the Food Safety Modernization Act’s Section 204 (also known as FSMA 204), sets additional record-keeping requirements for manufacturers, processors, packers and shippers of foods on the Food and Drug Administration’s Food Traceability List, which includes fresh produce staples. The FDA says the new requirements will help curb foodborne illnesses through faster identification and swift removal of food that is potentially contaminated.
Liz Sertl, senior director of community engagement for the not-for-profit information standards organization GS1 US, moderated the panel discussion at GOPEX. Panelists included Todd Baggett, president, CEO and founder of RedLine Solutions; Ray Connelly, vice president of supplier strategy at Procurant; Rafael Davila, business unit manager of four produce-focused microbiology laboratories for Eurofins; Andrew Kennedy, principal traceability advisor for FoodIDs; and Angela Nardone, chief operating officer for Share-ify.
Kennedy, who spent three years at the FDA working on FSMA 204, said what’s most important to understand about the rule is the additional record-keeping requirements for certain foods.
“The core element of the rule is the traceability block, and the traceability locked at the source,” he said. “That information is encapsulated in what we call physical tracking events, which are captured in some of those critical track events and include supportive key data elements that are shared with subsequent recipients That information can be not only stored but also requested by the FDA during an outbreak investigation in the form of the sort of restriction.”
Nardone said those critical tracking events include processes such as harvesting, cooling, packing, repacking, shipping and receiving. At each of those instances, the party responsible for that tracking event needs to collect data.
Connelly said it’s important to understand that the FSMA 204 regulation only applies to high-risk foods, not just fresh produce.
“Certain foods are more susceptible to foodborne illness and therefore necessitate the need for traceability,” he said. “What we’re sort of hearing generally across the retail community and there may be exceptions to this is that instead of sort of changing your process, and having highly traceable foods limited to the foods that you see on this list, we’re seeing entire category needing to be compliant.”
Nardone said some companies might be exempt, such as growers who make less than $50,000 a year or a restaurant with a three-year average under $250,000.
Connelly said one thing that these high-risk foods will need is more than “one-up, one-down” traceability. Those foods that are FSMA 204 eligible will need a high level of traceability.
Davila said field testing is an important part of traceability, and it’s a good idea for growers to field test and add those results in the data included in the crops harvested.
“If you are currently doing the testing, it’s always good to revisit it and question why the retailer has requirements on testing and do a really deep dive to try to get more value out of your testing data,” he said.
Kennedy walked attendees through a traceback from a restaurant to the shipper to the packer and to the location where the grower picked the produce. The level of detail includes a field map from harvest, the number of cases received and the receipt date.
“Think about each point in the supply chain; it’s vital to get records under today’s rule, which means a typical outbreak investigation takes at least a month, about 35 days,” he said. “And the goal is to shorten that time period down to less than a week.”
INTEGRATING TECHNOLOGY
Baggett said with the amount of data points needed to comply with FSMA 204, technology becomes a necessity. Manually entering data becomes tedious and runs the risk of being inaccurate.
“It’s been shown that key data entry is about 100 times less efficient or accurate than the bar-code scanning,” he said. “There’s no better time to collect that data than at the point of activity.”
The other challenge with data, Baggett said, is that companies complying with FSMA 204 must validate the data as companies collect it. Baggett says using bar-code scanners to verify the products pulled are correct helps ensure you don’t introduce errors and make tracebacks more challenging.
“I call it the axiom of 10,” he said. “Every step removed from where that error occurred costs you 10 times more. … Before you pick it up, there’s not much cost there [to fix]. But you move it to the dock and a truck arrives and now you’ve got to quickly hustle and put it back and get the right product. That’s another 10 times more expensive. If you actually shipped it, it’s 100 times more expensive.”
Connelly said another challenge to incorporating technology into the FSMA 204 compliance is that many companies have robust traceability within the business, but with the new rule they will need to share data throughout the supply chain.
“Under traceability, we’re being asked to supply that transfer of data between companies with a whole bunch of additional information that needs to be stored in the receiver system, and then carry forth to a broker or wholesaler, to the next guy and so forth, all the way up to retail. Can your system send data if you’re a supplier, and if you’re a receiver or a buyer, can your system receive data of this level in your current system?”
ADVICE TO THE AUDIENCE
Nardone said a critical element of FSMA 204 compliance is ensuring there is a task force devoted to leading the implementation of this rule.
Baggett told the audience that it’s also a good idea to start small, and if they’re not already participating in the Produce Traceability Initiative, that’s a good place to start.
“Look at your processes and consider the systems that you have,” he said, “One of the scary things that I see in the produce industry a lot is these little islands of automation or islands of data that don’t talk to each other. And one of the key things that we look at as we’re publishing our software is saying, ‘How do we make this open so that the next system down, if it’s a data transfer, can easily get that data and move that data forward?’”
Connelly said it’s also important to ensure the suppliers a company works with sends accurate data that operations can use.
“Assess your suppliers. Are they sending you traceability data that’s accurate, timely, in the format recommended and so forth?” he said. “And can you consume that data into your system? I would score your trade partners on both your supply side and on your sell side.”
Nardone said while many operations use their own lot numbers internally, a component of FSMA 204 is that the data from all steps in the fresh produce food chain is a part of the traceability data shared.
“So many people in the industry today, as a practice, assign their own lot number, and then that becomes your internal traceability. Part of what FSMA 204 changes is that now you have to take the manufacturer’s lot number and make sure that’s incorporated,” she said. “If you want to use that internal lot system for your own accounting purposes, there’s lots of good reasons to continue to do it. But the requirement is you have to take those farms, the lot number they assigned, and that has to be part of your traceability program.”
Source: www.thepacker.com
