What Is FSMA 204, and What Records Should Food Shippers Share With Carriers?

Food traceability is creating new documentation considerations for shippers, particularly as FSMA 204 affects recordkeeping for certain foods moving through the supply chain. For refrigerated LTL freight, a shipment may pass from a shipping facility to a carrier, through a cross-dock or terminal, and eventually to its final recipient.

At each stage, different parties may handle the product and its associated records. The distinction between traceability documentation and ordinary transportation paperwork is not always obvious. The same shipment documents may be used by shippers, carriers, warehouses, and receivers.

Clear responsibilities become especially important before freight enters the transportation network. Shipment information needs to be accurate, and records need to remain connected to the product.

When FSMA 204 Applies to a Shipment

FSMA 204 establishes additional traceability recordkeeping requirements for certain foods on the FDA Food Traceability List. The rule centers on Critical Tracking Events, or CTEs, and the Key Data Elements, or KDEs, associated with those events.

The requirements do not automatically apply to every food shipment.

The Food Traceability List includes certain:

• Soft and semi-soft cheeses
• Shell eggs
• Nut butters
• Fresh cucumbers and herbs
• Fresh and fresh-cut leafy greens
• Fresh melons, peppers, and tomatoes
• Certain fresh fruits and vegetables
• Certain finfish and shellfish
• Refrigerated ready-to-eat deli salads

Exemptions can apply, so product classification should be reviewed rather than assumed.

This distinction matters in refrigerated LTL. A carrier may move covered and non-covered products through the same network, but the additional traceability requirements depend on the food and the activities covered by the rule.

FSMA 204 also differs from sanitary transportation requirements. Temperature control, vehicle cleanliness, and handling practices address food safety during transportation, while traceability records document the movement of covered food through the supply chain.

The Records Behind a Covered Shipment

For a covered shipping event, the records center on Key Data Elements associated with the traceability lot.

Shipping records can include:

• Traceability lot code
• Product description
• Quantity and unit of measure
• Shipping location
• Shipping date
• Immediate subsequent recipient information
• Location information for the recipient

The traceability lot code is particularly important because it connects the shipment to other records associated with the food.

A product description and pallet count may identify what is moving, but they do not necessarily identify the traceability lot. That distinction becomes important when multiple lots of the same product are shipped.

The information also does not have to appear on one physical document. Bills of lading and electronic records can contain or link applicable information.

Location details deserve similar attention. A general company name may not identify the actual facility when a business operates several warehouses or distribution centers. Specific facility information provides a clearer connection between the product and the location involved.

Separating Carrier Information From Traceability Records

FSMA 204 does not mean that a carrier needs to receive every traceability record maintained by a food shipper.

A carrier transporting covered food is not automatically the immediate subsequent recipient simply because it takes possession of the freight. The immediate subsequent recipient is generally the next party receiving the food other than a transporter.

Carriers still need accurate information to transport refrigerated food correctly.

Some information can serve both purposes. A bill of lading, for example, may contain information useful for transportation while also supporting traceability records.

The practical step is to distinguish between information the carrier needs to move the freight and records the shipper must maintain or provide to the appropriate subsequent recipient.

LTL Handoffs Can Create Documentation Gaps

Refrigerated LTL adds more points of handoff than a dedicated truckload shipment.

Freight may move through terminals, cross docks, or multiple trailers before final delivery. During those transfers, the physical freight and its identifying information need to remain associated with each other.

A covered food shipment might move through:

Manufacturer → LTL carrier → Cross dock → LTL carrier → Distributor

Different businesses can perform different activities along that route. The manufacturer may record the shipping event, while a warehouse or distributor may have separate receiving or shipping responsibilities.

Several documentation issues can make a shipment harder to trace later:

• General product descriptions
• Corporate names instead of specific facility information
• Lot codes that are difficult to connect to shipment records
• Inconsistent shipment or reference numbers
• Records maintained separately without clear links

These issues may not affect routine delivery. They become more significant when a specific product lot needs to be identified across multiple locations.

Consistent shipment references help maintain that connection as freight moves through the LTL network.

Building the Record Before Pickup

The best time to identify a documentation gap is before the truck arrives.

A pre-pickup review can confirm that the necessary information is available before freight enters the LTL network.

Food shippers can review:

• Whether the product is covered by FSMA 204
• The applicable traceability lot code
• Required shipping KDEs
• The actual shipping facility
• The immediate subsequent recipient
• How the records will be linked
• What information the carrier needs
• Temperature and handling requirements

Existing business records may already provide much of the necessary information. Bills of lading, warehouse records, and electronic shipping systems can help maintain or connect applicable records.

A useful operational test is to follow one covered shipment from pickup through delivery:

• Identify the product and traceability lot.
• Confirm the shipping facility.
• Review the shipping documentation.
• Follow the freight through any terminal or cross-dock.
• Confirm that shipment information remains connected.
• Verify the receiving information.

This process can reveal gaps that are difficult to see when individual documents are reviewed separately.

Congress directed FDA not to enforce the Food Traceability Rule before July 20, 2028. The additional time allows covered businesses to review their recordkeeping processes and coordinate requirements with transportation partners.

Frequently Asked Questions

Does the lot code need to be on the packaging?

Not necessarily. The traceability lot code can be maintained through records or documents that connect the food with its applicable traceability information.

Can a bill of lading support FSMA 204?

Yes. A bill of lading can contain or link applicable shipping information. It does not necessarily need to contain every record maintained by the covered business.

Are carriers responsible for traceability records?

Not simply because the carrier transports the food. Responsibilities depend on the activities performed and the requirements applicable to each business.

What if covered food goes through a warehouse?

The warehouse may have separate traceability responsibilities when it receives, holds, or ships covered food. Records should reflect the applicable activities performed by the businesses involved.

How quickly must records be provided?

Covered businesses generally must make required records available to FDA within 24 hours of a request, unless another reasonable timeframe is agreed upon.

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