What You Need to Know About FSMA 204: The Food Traceability Final Rule

What is FSMA 204 (The Food Traceability Rule)?

Section 204 of FSMA, known as the Food Traceability Rule, directs the FDA to identify high-risk foods requiring additional records and to establish the corresponding recordkeeping requirements. The objective of FSMA 204 is to expedite the identification and removal of potentially contaminated food from the market, reducing the incidence of foodborne illnesses and deaths.

The FDA published the final rule, titled “Requirements for Additional Traceability Records for Certain Foods,” on November 21, 2022. The remainder of this resource is dedicated to exploring the intricacies of FSMA 204.

FSMA 204 Requirements

The Food Traceability Rule mandates that businesses involved in manufacturing, processing, packing, or holding foods on the Food Traceability List (FTL) maintain records with key data elements (KDEs) for specific supply chain activities, which the FDA has defined as critical tracking events (CTEs). This information must be captured, stored and maintained for 24 months, and event data must made available to the FDA within 24 hours upon request. Additionally, shipping events must be shared with supply chain partners.

CTES ARE EVENTS ALONG THE SUPPLY CHAIN THAT REQUIRE ENHANCED TRACEABILITY RECORDKEEPING AND KDES ARE THE PIECES OF INFORMATION THAT SHOULD BE INCLUDED IN EACH RECORD.

The Traceability Rule also requires that businesses establish and uphold a traceability plan, outlining procedures for record maintenance under the new requirements, identification of FTL foods handled, and the assignment of traceability lot codes to FTL foods.

When is the Compliance Date?

The FSMA 204 Final Rule took effect in January 2023, and companies have been granted a three-year compliance period. The compliance date is January 20, 2026, for all companies covered by the rule.

Who Must Comply?

Business who manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

What is a Traceability Lot Code?

A Traceability Lot Code (TLC) is a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code. Food industry workgroups recommend the use of a Global Trade Item Number (GTIN), plus the product lot code to create a unique and traceable TLC.

When is a Traceability Lot Code Needed?

Entities are obligated to assign traceability lot codes under specific circumstances. These include the initial packing of raw agricultural commodities (excluding those from fishing vessels), the first reception of a food from a fishing vessel on land, or when transforming a food product. However, activities like shipping do not require the creation of a new traceability lot code, unless otherwise specified.

What Goes Into a Traceability Plan?

If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan. This plan should include details such as record-keeping procedures, methods for identifying FTL items, the assignment of traceability lot codes (if applicable), a designated point of contact for inquiries about the plan, and, for those growing or raising listed foods, a farm map displaying growing areas. The farm map must include specific details like location, field names, and geographic coordinates. Aquaculture farms must provide container details instead of field information. Entities are required to update the traceability plan as needed to reflect current practices and remain compliant, retaining the previous version for two years after updates.