FSMA Food Traceability Rule: What Shippers Need to Know

The Food Traceability Rule of the Food Safety Modernization Act (FSMA) obligates manufacturers and processors of certain foodstuffs to record Critical Tracking Events (CTEs) during the harvesting, processing, and storage process to provide the Food and Drug Administration (FDA) with easy-to-access information about an affected product’s journey from the farm to the tables of U.S. citizens.

What Is the FSMA Food Traceability Rule?

The FSMA Food Traceability Rule (FTR) is the mechanism by which Section 204(d) of the FSMA is executed. It applies to manufacturers, processors, packers, and distributors of foodstuffs that appear on the FDA’s Food Traceability List (FTL). 

This rule is separate from the FSMA’s Sanitary Transportation Rule already in effect.

When Does the FSMA Food Traceability Rule Take Effect?

The original Food Traceability Rule compliance date was January 20, 2026. FDA later proposed extending that date by 30 months to July 20, 2028, and Congress directed FDA not to enforce the rule before July 20, 2028. 

Shippers can use the time between now and the 7/20/28 implementation date to identify which products they offer are affected by the rule and build data-sharing strategies with their partners throughout the supply chain. Consulting with a logistic professional during this process provides an added level of assurance that those strategies will be data driven, thoroughly documented, and able to withstand FDA scrutiny.

Which Foods Are Covered by the Food Traceability Rule?

The FTR applies to specific types of produce, dairy products, seafood, and composite goods that contain those ingredients. Affected foodstuffs are listed on the FTL, with notable exceptions and specific requirements stated as well.

The FTL doesn’t cover every refrigerated foodstuff, but its applications aren’t always obvious to shippers.

Does the Food Traceability Rule Apply to Every Refrigerated Food Shipment?

No, not all shipments of refrigerated food trigger FTR requirements. However, the foods to which the FTR does apply can be used as ingredients in aggregate food products that might not be as obvious to shippers. Under this circumstance, refrigerated foods may or may not be subject to the FTR depending on the exemptions mentioned in the previous table.

What Are Critical Tracking Events?

Within supply chains, a Critical Tracking Event (CTE) is an event to which the FTR applies specific traceability information requirements.

The FTR identifies seven CTEs for affected foods:

1. Harvesting
2. Cooling prior to initial packing
3. Initial packing
4. First land-based reception 
5. Shipping
6. Receiving
7. Transformative processes

For each of these CTEs, the FDA lists Key Data Elements (KDEs) that must be recorded.

What Information Must Shippers Record?

Shippers are required to record the KDEs associated with shipping affected foodstuffs, which are:

• The traceability lot code (a batch identifier such as CHE-051-A for affected cheese) for the food in question
• Quantity of food shipped and unit of measure
• A product description
• Location descriptions for:
  • The immediate subsequent recipient other than a transporter
  • The location from which the food was shipped
• The date of the food shipment
• A location description for the traceability lot code source or source reference
• Reference document type and the reference document number for recordkeeping purposes

Shippers are given some latitude in the manner they choose to retain these documents.

Tom Aumann, R+L's Vice President of Flatbed and Over-Dimensional Services offers the following advice to affected shippers:

“Make sure all the information is in front of you and kept intact. It’s data accumulation: what were the temperatures the product was held at and exposed to, what were the handling requirements, and who had access to the shipment? As the product moves, it accumulates data like a snowball rolling downhill, and that snowball of information needs to stay cohesive even as it grows larger until the shipment reaches the end user."

Do FSMA Traceability Records Have to Appear on the Bill of Lading?

No. While the information that applies to food traceability and food transportation are related, they aren’t identical and BoLs don’t have to contain traceability records, though shippers do have the option of fulfilling maintenance record requirements via Bills of Lading. 

Other documents shippers could use for this purpose include but aren’t limited to:

• Invoices
• Warehouse records
• Advance shipping notice
• Warehouse Management Systems (WMS)
• Enterprise Resource Planning (ERP) systems
• Systems dedicated specifically to traceability requirements

While the BoL doesn’t have to contain traceability records, that information does have to be recorded and maintained by the shipper.

How Long Must FSMA Traceability Records Be Kept?

Shippers must maintain FSMA traceability records for two years per Section 204, which authorizes the FDA to require document retention for no more than that amount of time. The records must also be readily available. If the FDA requests required traceability records, covered entities generally must provide them within 24 hours of the request, or within another reasonable time agreed to by the FDA. 

How Can Refrigerated Food Shippers Prepare for FSMA 204?

Shippers of refrigerated foodstuffs can prepare for the Section 204 recordkeeping requirements of the FSMA by identifying the following data elements: 

1. Which foods handled by the shipper appear on the FTL
2. Whether exemptions or partial exemptions apply to the shipment
3. CTEs performed and their related KDEs
4. Where TLCs are brought into the company workflow
5. Map required information against existing documentation
6. Develop reliable methods of communicating KDEs between business partners
7. Perform test procedures to ensure the information is accurate, easy to retrieve, and consistent across the supply chain

If you’re a shipper looking for a logistics partner with a proven record of refrigerated freight shipping compliance, call our team of experts at (866) 849-4923 or contact us online today.

Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs), U.S. Food and Drug Administration