Preparing for U.S. Food Traceability Final Rule

The U.S. continues to transform its food safety system with more stringent rules and regulations. After changes to the National Organic Program, new changes are coming to the Food Traceability Final Rule, section 204 of the Food Safety Modernization Act (FSMA).

The U.S. Food and Drug Administration’s (FDA’s) Requirements for Additional Traceability Records for Certain Foods, also known as the Food Traceability Final Rule (FSMA 204), requires more record-keeping from entities manufacturing, processing, packing or holding foods that are on Food Traceability List (FTL). Food items such as cheese, cucumbers, shell eggs, nut butters, leafy greens, herbs, melons, and peppers are included in the FTL, among others.

“This new rule requires additional record-keeping for consumer protection. It’s worth checking if these additional requirements apply to your business and what else you might need to do to build on what you’ve already got. And if you’re starting from scratch and might not have anything in place, you’ve probably got a bit more work to do,” said Matthew Taylor, global senior manager of food consulting at NSF.

FSMA 204 was finalized on November 15, 2022, and businesses have until 2026 to comply. Taylor encourages early preparation as routine inspections are anticipated to begin in 2027. “Meeting the deadline can be extremely challenging if preparations are put off until just before the compliance date,” he said.

The rule employs a set of metrics known as key data elements (KDEs), which correspond to critical tracking occurrences (CTEs) such as harvesting, cooling, shipping, and receiving. Entities using any of these CTEs for foods on FTL must adhere to the additional record-keeping requirements.

“A good way to pressure test your business is to undertake a mock recall traceability exercise with your crisis management team. Demonstrate that you can get all the information you need as per your traceability plan. This will help you identify gaps if there are any in areas that you can improve on,” Taylor said.

To prepare for FSMA 204, businesses should first review the rule in detail, paying special attention to FTL and applicable exemptions. Consulting the FDA’s reference guide on CTEs and KDEs is crucial to determining which elements need recording. For example, a food processor might be classified as a receiver, transformer, and shipper, necessitating comprehensive tracking.

In addition to documenting KDEs, businesses must develop a robust traceability plan, maintain legible records in printed or electronic form, and ensure that records are available to FDA within 24 hours of a request.

“Essentially, it’s about record-keeping requirements. That’s what you’re going to have to do—to have records managed in a certain way to be able to provide that quickly and locate quickly,” Taylor said.

The traceability plan should outline procedures for maintaining records, identifying foods on FTL, and detailing how traceability lot codes are assigned. Businesses should also include contact points for questions regarding the traceability system and supporting documents, such as records of quality control tests performed on finished products, including results and any corrective actions taken.

For those feeling overwhelmed by the new rule, Taylor advises, “Don’t be too overwhelmed by the new rule. It’s always scary when a new piece of legislation comes out, but if you go back to FISMA 2011, everybody was worried about that too. Ultimately, this is about keeping the food and the consumers safe.”

Several organizations are offering support services to help businesses navigate these changes. The FDA provides a wealth of resources on its website, including FAQs and webinar recordings. NSF also offers Initial Scoping Workshops, where businesses can review their products against FTL, verify documentation, and determine if a full FSMA 204 readiness assessment is needed.

While paper records are allowed under the rule, Taylor encourages businesses to consider technology to streamline compliance. “Consider investing in a platform that can automate data gathering and securely save information,” he suggested. On-demand traceback capabilities are particularly vital for responding swiftly during a food safety incident.

The new rule represents a significant shift in the food industry, aiming to create a more robust and resilient global food supply chain. Taylor predicts FSMA 204 may eventually expand to cover more products: “I wouldn’t be surprised if we see the rule extended beyond products that are currently listed on the food traceability list. This could become more widespread.”

Ultimately, the objective of FSMA 204 is to enhance food safety and protect consumers. “It’s doing your duty to protect the consumer. If there’s a problem, you’ve got to be able to react within 24 hours to pull that product,” Taylor said.

This approach not only safeguards public health, but also protects the integrity of brands that have been built over the years. “It’s also protecting your brand. Having a food safety incident is going to be costly to your brand apart from the legal implications,” Taylor said.