As the food industry prepares for the January 2026 deadline for compliance with the Food Safety Modernization Act (FSMA) Rule 204 for food traceability, food processors are relying on advanced technologies to automate operations and collect and analyze data. 

The traceability requirements are intended to enable faster identification and more rapid removal of potentially contaminated food from the market, thereby reducing foodborne illnesses and related deaths. The rule requires those who manufacture, process, pack or hold foods on the Food Traceability List to maintain records containing Key Data Elements associated with specific Critical Tracking Events and provide that information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.

Although there are obstacles to complying with Rule 204 requirements, such as the lack of standardized data formats and interoperable systems internally and between supply chain partners, traceability will bring food processors benefits beyond compliance by delivering production, inventory and shipment visibility. Such visibility offers the potential to:

• Identify food safety deviations and prevent recalls
• Limit human error
• Improve cybersecurity, operational efficiency, and asset utilization
• Overcome supply chain disruptions
• Expedite replenishment
• Automate reordering
• Achieve ESG (environmental, social, governance) goals
• Meet consumer demands for a greater variety of stock-keeping units
• Address the growing volume of smaller, more frequent orders and direct-to-consumer shipments
• Enhance transparency and consumer engagement
• Build brand identity
• Facilitate recycling

The technology needed to achieve traceability typically involves networked coding, labeling, printing and reading equipment, as well as related software and digital tools for remote machine monitoring and data collection, storage and analysis. Web-based solutions offer flexibility and easy access. AI can play a vital role by collecting large volumes of data and identifying patterns that are not discernible by human operators.

To maximize food safety, food processors are specifying machines with clean-in-place (CIP) functionality and a minimum of touchpoints, according to the 2024 State of the Industry Report from PMMI, The Association for Packaging and Processing Technologies. If CIP isn’t feasible, OEMs are being asked to supply clean-out-of-place tooling that is easy to manage to minimize downtime and risks for contamination. Food processors are also ordering automated systems that document cleaning times and temperatures to confirm compliance and provide an alert of any deviation that could result in a recall.

Rule 204 is just one regulation impacting food processors. Many others are pending or under consideration. These include pending FDA requirements for lead levels in fruit juices and baby food. Lead in other products is a concern at federal and state levels, and there are discussions about additives like artificial colors, propylparaben and potassium bromate. Other potential targets for regulatory action include PFAS (per- and poly-fluoroalkyl substances), bisphenols, phthalates, polyvinyl chloride and microplastics.

Regulators, especially at the state level, also are scrutinizing sustainability efforts. AMERIPEN, a materials-agnostic group that develops and advocates on issues related to packaging and the environment for the North American packaging value chain, expects this activity to continue primarily in five areas: extended producer responsibility (EPR), source reduction, labeling claims regarding recycling or compostability, recycled content and chemicals in packaging. 

To help consumers make healthier food choices, the FDA is studying the addition of front-of-pack labeling for saturated fat, sodium and sugar to supplement the current Nutrition Facts label. This would require changes to every label and carry a hefty price tag if finalized. It also could generate reformulation costs if food processors opt to change recipes to improve their product’s nutritional profile. 

Food processors working to enhance product and worker safety will be able to explore new technologies, observe equipment in action, compare machines, meet key partners and find new packaging materials at the first PACK EXPO Southeast, set for March 10-12 at the Georgia World Congress Center in Atlanta.