The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), passed and signed into law in 2011, established a roadmap for protections in the public food safety system. The interconnectedness of the global food supply chain requires both prevention and response protocol to ensure safety for the consumer, and this goal remains at the center of FSMA. Since that time, several major rules associated with FSMA have been finalized, the most recent being 204(d): Food Traceability Final Rule. Passed in November 2022, FSMA 204 establishes specific guidance for enhancing traceability, improving response times for outbreaks and contaminations, and building a stronger food safety culture as a whole.
All entities will need to meet compliance of FSMA 204 by January 20, 2026.
Wherefour is committed to being your compliance partner for the upcoming implementation. Throughout 2025, we’ll make sure you don’t get left behind on updates and best practices for regulatory compliance. So let’s start at the beginning. Here’s a comprehensive breakdown of FSMA 204.
FSMA 204 requires compliance by all persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL). Is that you? Find out at this link: FTL.
FSMA 204 identifies Critical Tracking Events (CTE) along the supply chain where Key Data Events (KDE) occur. All CTEs, KDEs and any and all associated Traceability Lot Codes (TLC) must be recorded, standardized and maintained.
CTEs include the following: HARVESTING, COOLING, INITIAL PACKING, FIRST LAND-BASED RECEIVER, SHIPPING, RECEIVING, and TRANSFORMATION. “Transformation” is an umbrella term that encompasses most processes in the MANUFACTURING sector, as it includes production steps such as commingling, mixing, repackaging, relabeling, etc.
At every point along the CTE flowchart, KDEs must be maintained. This relies on unique product identification and effective traceability standards. See Wherefour’s blog Best Practices for Assigning and Using Lot Codes for more information.
Once CTEs, KDEs and TLCs are identified, every operation must develop a TRACEABILITY PLAN. This Plan establishes and maintains procedures for record keeping, data reporting, assigning a point of contact, and establishing recall response protocol.
Employing a cloud-based ERP platform for your day-to-day operations provides an advantage in achieving FSMA 204 compliance. The use of a centralized single source of truth ensures that all aspects of your operation are integrated, data management is streamlined, and end-to-end traceability is built-in. Recall Readiness is a foundational feature in Wherefour’s ERP suite, so you can be confident that your data is accurate, accessible and permanently tied to your product’s full timeline — from raw material to point-of-consumption.
Wherefour is committed to streamlining interagency communication. Compliance on the global food supply chain depends on cooperation and strict compliance at the individual level. Don’t get left behind — stay tuned for more FSMA 204 updates and information as January 20, 2026 approaches.
See the FDA’s FSMA “At-A-Glance” Fact Sheet HERE.