Food (USA)

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The Food Safety Modernization Act (FSMA) represents the most significant overhaul of food safety laws in over 70 years. Signed into law in 2011, FSMA shifts the focus from responding to foodborne illnesses to preventing them.

Section 204 of the Food Safety Modernization Act (FSMA), a U.S. regulation aimed at improving food traceability to enhance food safety and speed up responses to foodborne illness outbreaks.

The compliance date for FSMA 204 has been officially extended and it is now July 20, 2028, for all companies covered by the rule. The FSMA 204 Food Traceability Rule requires businesses handling foods on the Food Traceability List (FTL) to maintain detailed records of Key Data Elements (KDEs) at specific Critical Tracking Events (CTEs) throughout the supply chain. Below is a comprehensive outline of the CTEs and the KDEs that must be captured at each stage.

FSMA 204 applies to foods listed on the FDA’s Food Traceability List (FTL), which includes high-risk items such as fresh-cut fruits and vegetables, leafy greens, tomatoes, cucumbers, soft cheeses, shell eggs, certain seafood, and ready-to-eat deli salads. Companies that manufacture, process, pack, or hold these products are required to maintain enhanced traceability records under the rule.

FSMA 204 Traceability Regulation for Food Products in the U.S.

1A. FIRST LAND-BASED RECEIVER (For Seafood)

Who: The first facility on land to receive seafood from fishing vessels.

Purpose: Capture the first land-based handling of seafood, linking fishing vessel origin to the supply chain.

Notes:

The Traceability Lot Code (TLC) must be unique and linked to the packed product.

1B. HARVESTING

Who: Farms and farm mixed-type facilities removing raw agricultural commodities (RACs) from the field.

Purpose: Identify origin and ensure traceability from the very start of the supply chain.

COOLING (Before Initial Packing)

Who: Facilities that actively reduce the temperature of RACs after harvest but before packing.

Purpose: Document temperature control measures and maintain lot linkage before packing.

INITIAL PACKING

Who: Facilities that pack RACs for the first time (excluding seafood from fishing vessels).

Notes:

• The Traceability Lot Code (TLC) must be unique and linked to the packed product.

• GTIN (Global Trade Item Number) can be used to identify product instead of detailed description if a glossary is maintained.

Purpose: Assign and record the TLC, linking packed product to its origin and ensuring traceability downstream.

SHIPPING

Who: Any entity shipping FTL foods to the next supply chain partner.

Purpose: Document movement of products with associated lot codes to maintain chain of custody.

RECEIVING

Who: Entities that take physical possession of packed RACs or other FTL foods.

Notes:

• Receiving of unpacked RACs prior to packing is not required to have KDEs; initial packer must identify farm and harvest location.

Purpose: Confirm receipt of traceable lots and maintain continuity of traceability data.

TRANFORMATION

Who: Facilities that process or transform FTL foods into new products (e.g., processors, manufacturers).

Purpose: Link input lot codes to output lot codes to maintain traceability through processing changes.

Additional Notes

• Traceability Lot Codes (TLCs): Must be assigned at initial packing or transformation and linked at each CTE to ensure traceability continuity.

• Record Retention: All KDEs and CTE records must be maintained for 24 months and be made available to the FDA within 24 hours upon request.

• Traceability Plan: Businesses must maintain a plan describing how they assign TLCs, maintain records, and identify FTL foods handled.

THE GOODS ARE SHIPPED TO RETAILER

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