Your Guide to FSMA 204 Compliance

The final rule establishes additional additional traceability recordkeeping requirements for those that manufacture, process, pack or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables and ready-to-eat deli salads. In collaboration with industry, the FDA will be able to more rapidly and effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.

Because the Food Traceability Final Rule requires entities to share information with other entities in their supply chain, the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date. The compliance date for all persons subject to the recordkeeping requirements was Tuesday, January 20, 2026. The compliance deadline has now been delayed by 30 months to July 20, 2028.

• Many fresh fruits and vegetables:
  • Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, all fresh-cut fruits, and all fresh-cut vegetables
• A variety of soft cheeses:
  • Fresh soft, soft un-ripened, soft ripened, and semi-soft cheeses made from pasteurized milk
  • Cheeses made from unpasteurized milk, other than hard cheeses
• Shell eggs
• Nut butters
• Some categories of seafood:
  • Fresh and frozen finfish, refrigerated and frozen smoked finfish, fresh and frozen crustaceans, and fresh and frozen molluscan shellfish and bivalves
• Refrigerated RTE (ready-to-eat) deli salads

• Harvesting
• Cooling
• Initial Packing (applies to Raw Agricultural Commodities not obtained from a fishing vessel)
• First Land-Based Receiver (applies only to seafood)
• Shipping
• Receiving – this is where ArrowStream will primarily assist
• Transformation

Every step in the process requires slightly different KDEs, but for the receiving at the restaurant location, it’s required to collect the following:

Traceability lot code for the food

• Quantity and unit of measure of the food
• Product description for the food
• Location description for the immediate previous source (other than a transporter) for the food
• Location description for where the food was received
• Date you received the food Location description for the traceability lot code source or the traceability lot code source reference
• Reference document type and reference document number

Create and maintain a traceability plan Maintain records as original paper records, electronic records, or true copies (must be legible and stored to prevent deterioration or loss).​

• Provide traceability records (and any information necessary to understand these records) to the FDA no later than 24 hours after a request is made (or within a reasonable time to which the FDA has agreed).​
• Provide an electronic sortable spreadsheet containing relevant traceability information to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist during an outbreak, recall, or other public health threat.

For more information and the latest updates, you can consult the FDA website.