Compliance Guidance for Food Safety Modernization Act Food Traceability Rule

The U.S. Food and Drug Administration released a compliance guide in May to help small entities such as farms and other small businesses in the food supply chain comply with the Food Safety Modernization Act (FSMA) Food Traceability Rule requirements. The FDA issued the rule in November 2022, with an effective date of Jan. 20, 2026. The rule applies to domestic as well as foreign companies that provide farm-to-table food for U.S. consumption.

Because smaller companies tend to struggle with complex regulatory compliance, the FDA issued the guide to help them understand and meet their obligations under the rule. The guidance addresses topics such as traceability plans, record keeping requirements and exemptions. Compliance is essential to remove contaminated food efficiently and quickly from the food supply chain, with the goal of reducing foodborne illnesses.

The Food Traceability Rule is a pillar of the FDA’s “New Era of Smarter Food Safety” blueprint. It implements FSMA section 204(d), which mandates that the FDA designate high-risk foods requiring additional record keeping to support tracking efforts and protect public health. Key data such as commodity type, date, quantities, activity location and traceability lot code must be recorded during critical tracking events such as harvesting, cooling, packing, shipping, receiving and transformation of food. The intention is to enable faster identification and removal of potentially contaminated food from the market.

The rule applies to entities that grow, process, pack, hold, distribute and serve foods that appear on the Food Traceability List. Such foods include, but are not limited to:

• Cheese
• Shell eggs
• Fish and crustaceans
• Nut butters
• Leafy greens, sprouts and fresh herbs
• Various vegetables
• Tropical tree fruits
• Fresh-cut fruits and vegetables
• Ready-to-eat deli salads

Recommended next steps

Companies should review the FSMA Food Traceability Rule and consult the FDA’s compliance guide to assess their current traceability plans and make any necessary improvements. Steps to provide efficient and complete tracing of their products throughout the food supply chain include the following:

• Ensure key data elements are recorded for certain critical tracking events in current traceability plans.
• Optimize systems and processes to collect, harvest, transform and store data.
• Implement technology solutions that offer end-to-end visibility and traceability.
• Establish a robust product recall plan that works in conjunction with traceability, enabling the swift removal of dangerous products from the market.

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