Food Traceability Rule (FSMA 204)

Coming Soon!

The FDA Food Safety Modernization Act (FSMA), enacted in 2011, empowers the FDA to bolster public health by strengthening the food safety system through new regulatory actions. FSMA is the compilation of many FDA food regulations, encompassing stringent rules for food production, enhanced inspection and compliance measures, increased accountability throughout the food supply chain, and a heightened emphasis on science-based risk assessment and prevention. To date, these include:

Soon to join this mix of FSMA regulations is the Food Traceability Rule (FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA), commonly referred to as 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, or FTL (Food Traceability List | FDA) 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.

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.

Who Must Comply

Business who manufacture, process, pack, or hold foods on the Food Traceability List (FTL). That said, there are several full or partial exemptions, waivers, and modified requirements from the rule in the FDA guidance document “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA”.

What is The Food Traceability List?

The Food Traceability List (FTL) identifies the foods for which the additional traceability records are required. The additional recordkeeping requirements apply not only to foods specifically listed on the FTL, but also to foods that contain foods on the list as ingredients.

The Food Traceability List (FTL) identifies the foods for which the additional traceability records are required. The additional recordkeeping requirements apply to the foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.

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, with routine inspections being conducted shortly thereafter.

EAS Consulting Group provides regulatory assistance to FDA food manufacturers in FSMA compliance, to include FSMA 204 compliance. We offer services to develop FDA compliant traceability programs, remote or in-person gap assessment, as well as mock FDA inspections. Contact us if we can be of help understanding the requirements of this temporary guidance document or as you prepare your documentation.