Guidance for FSMA Rule 204 compliance

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Guidance for FSMA Rule 204 compliance

12 Nov 2024

Mari Rydings

Mari Rydings is a versatile content creator, editor and marketer with experience developing dynamic, results-driven materials for B2B and B2C audiences. As the editorial director for Avant Food Media, she leads the day-to-day editorial operations for the company’s print and digital magazines, newsletters and social media platforms. Outside of work, she loves reading, hiking, putting together jigsaw puzzles and spending time with her husband and their twin daughters.

KANSAS CITY, MO — While bakeries may have many of the pieces required by FSMA Rule 204 in place, that doesn’t mean they’ll be considered compliant come January 2026. There’s still work to be done.

“Get started now,” advised Sara Bratager, senior food safety and traceability scientist at the Global Food Traceability Center, which is part of the Institute of Food Technologists. “A year and a half seems like a long time, but traceability is a group project, and group projects always take longer than expected. First, look at the food traceability list to determine if you handle any ingredients on the list. Then, start talking with your trading partners to make sure everyone is on the same page with what and how data will be collected and shared. Finally, take time to train your employees. Data doesn’t magically collect itself, and you need to make sure you’re collecting the right data in the right way and getting it to the right place.”

Another factor to consider is whether it makes sense to have a separate process for tracing products containing FDA’s Food Traceability List (FTL) items.

“We are seeing more entities in the supply chain saying, ‘We’re going to have one system for everything because it’s just too hard to differentiate between this cake, which has sliced strawberries on top, and this one that doesn’t,’” said Ben Miller, executive VP of regulatory and scientific affairs for The Acheson Group, a full-service global food safety consulting company. “Consider if it’s going to be more work maintaining two systems versus creating a central approach to traceability.”

How FDA will track compliance on a routine basis outside of an outbreak investigation isn’t clear yet. The current sense from Miller and Bratager is that compliance checks will eventually become part of existing food safety audits such as the British Retail Consortium Global Standard and other Global Food Safety Initiative-recognized programs.

“I think it will be a mix of food safety audits combined with trading partner interactions that check to see how traceability is being implemented,” Bratager predicted. “Customers want to know their suppliers are following the law. Food companies will outnumber the amount of staff the FDA has to conduct compliance checks, but a customer saying, ‘You’re not following the laws so you can’t be my supplier anymore,’ can be just as damaging as a slap on the wrist from the government. You absolutely want to have your ducks in a row.”

“It will be interesting to see how traceability evolves in the future and whether it becomes a more mainstream ‘requirement’ without a regulatory obligation in the supply chain.” — Rasma Zvaners | VP of government relations | American Bakers Association

On an impact scale of low to high, Miller anticipates FSMA Rule 204 will fall somewhere in between.

“For food manufacturers, a lot of this is already happening,” he said. “It’s more about standardizing what’s already occurring and making sure there’s good data exchange from your suppliers. It’s not going to require a huge internal change for most manufacturers, but maybe some tweaks here and there. It’s going to have less of an impact than it will on other industry segments like the food distributors.”

FDA’s restructuring of its Human Foods Program, which is currently underway, is expected to create a nimbler organization better positioned to maintain the safety of the US food supply and respond faster to food-related emergencies. It’s a move that could affect future enforcement activity related to food traceability.

“There has been an ongoing conversation over the years about how to more quickly react in a recall scenario and pull the impacted products,” said Rasma Zvaners, VP of government relations for the American Bakers Association. “It will be interesting to see how traceability evolves in the future and whether it becomes a more mainstream ‘requirement’ without a regulatory obligation in the supply chain.”

While industry awareness of FSMA Rule 204 requirements is growing, there is still some ambiguity in certain sections of the supply chain. Engaging in collaborative conversations now can minimize confusion and ensure affected food manufacturers, their suppliers and distributors are fully compliant come 2026.

This story has been adapted from the August | Q3 2024 issue of Commercial Baking. Read the full story in the digital edition here.

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