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The Path to FSMA 204 Compliance

Key Insights on the FDA's Food Traceability Final Rule

The FDA established the Food Traceability Final Rule as part of its proactive approach to food safety, a pivotal aspect of the New Era of Smarter Food Safety Blueprint. The final rule implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA) by enforcing stringent recordkeeping for entities that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL).


These new requirements are designed to enhance the traceability of food products and the responsiveness of the food safety system. They aim to facilitate quicker identification and removal of potentially contaminated foods from the market with the goal of reducing the incidence of foodborne illnesses and deaths.

 

This rule went into effect in January 2023, with full compliance required by January 20, 2026.


Who Must Comply with FSMA 204?


The additional traceability requirements create the need for information sharing across the supply chain and apply to any entity that manufactures, processes, packs, or holds foods on the FTL. This may include farms, food manufacturers and processors, distributors, warehouses, retailers, and foodservice operators. While only those handling FTL foods are mandated to comply, the FDA is encouraging all food businesses to adopt similar traceability practices.


What Foods are Covered?


The rule specifically targets products listed on the FDA’s Food Traceability List (FTL). These are generally foods deemed high-risk for causing foodborne illness. The FTL includes the following products.


  • Many fresh fruits and vegetables, such as cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, and tropical tree fruits
  • Soft cheeses made from pasteurized or unpasteurized milk
  • Shell eggs
  • Nut butters
  • Certain seafood products, including fresh and frozen finfish, smoked finfish, crustaceans, and molluscan shellfish


A full list can be found at https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list. 


Critical Tracking Events and Key Data Elements


For each of these foods, businesses must maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs) in the supply chain.

 

Critical Tracking Events (CTEs)


The final rule lists the following CTEs: harvesting, cooling (before initial packing), initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, and transformation of the food.


Key Data Elements (KDEs)


The required KDEs vary depending on the CTE and include specifics such as the origin, date of transaction, quantity of food, and traceability lot codes (TLCs), which uniquely identify a batch within the supply chain. The records must be detailed enough to track the path of food from origin to point of sale or service, ensuring that all information is easily accessible and can be swiftly compiled into an electronic, sortable format if requested by the FDA.


Entities covered by the rule must ensure that their records are not only accurate and up-to-date but also readily accessible within 24 hours of an FDA request, to facilitate rapid response during health emergencies.


Preparing for FSMA 204 Compliance


Businesses covered by FSMA 204 have until January 2026 to fully implement the new traceability requirements. However, many supply chain partners are already requiring compliance starting in 2023.

To prepare, companies should:


  1. Understand the Law: Thoroughly review the FSMA 204 requirements to understand which foods are covered, what records must be maintained, and the compliance deadlines.

  2. Assess Your Business: Determine if the foods you manufacture, process, pack, or hold are included on the FDA's Food Traceability List (FTL). Check the list to see which of your products are affected.

  3. Implement a Traceability Program: Develop and implement a comprehensive traceability program that meets the FSMA 204 requirements. This includes maintaining records of critical tracking events and key data elements for FTL foods.

  4. Collaborate with Supply Chain Partners: Work closely with your suppliers, customers, and other supply chain partners to ensure end-to-end traceability and the ability to share records quickly when requested by the FDA.

  5. Invest in Traceability Technology: Consider adopting digital traceability solutions to automate data collection, management, and sharing to simplify compliance.

  6. Conduct Mock Recalls: Regularly test your traceability program by conducting mock recalls to identify and address any gaps.

  7. Train Your Team: Ensure all relevant employees are properly trained on the FSMA 204 requirements and their role in maintaining compliance.

  8. Be Prepared for Inspections: Have a plan in place to present your traceability records and program to the FDA during potential inspections.


By taking these proactive steps, facilities can help ensure they meet the FSMA 204 requirements and avoid the significant penalties for non-compliance, which can include fines, product recalls, and even suspension of operations.


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