The Food Safety Modernization Act was enacted in January 2011 with the goal of enhancing the safety of the United States food supply. The act focused on supply chains, aiming to prevent contamination incidents. Since 2011, there have been several updates to FSMA, including the most recent regulation – FSMA 204. We read the 597 pages of the FSMA 204 ordinance in order to distill everything you need to know into this blog, including what it is, why it is important and what it will mean for your supply chain operations.

What is FSMA 204?

Section 204(d) of the Food Safety Modernization Act is an update by the Food and Drug Administration (FDA) to allow for faster identification and rapid removal of potentially contaminated food from the market. This new ruling establishes traceability recordkeeping requirements for companies that manufacture, process, pack or hold foods identified as having a higher food safety risk. Products on the Food Traceability List (FTL) include produce, fish, eggs, nut butters and cheese. Organizations involved in those categories have until January 2026 to make their supply chain compliant with the new traceability requirements.

Key terminology

FSMA 204 requires supply chains moving products on the FTL to implement traceability processes to track each checkpoint that the product goes through from source to consumer. There are several terms that supply chain leaders will need to be familiar with to fully understand their role in maintaining FSMA 204 compliance.

Food Traceability List (FTL) – The FTL contains items identified by the FDA as having a higher food safety risk. Foods may be added to or removed from this list at any point.

Critical Tracking Events (CTE) – CTEs are events in the supply chain where an FTL item is harvested, packed, shipped, received or transformed.

Key Data Elements (KDE) – KDEs are data attributes specific to each CTE.

Traceability Lot Code (TLC) – The Traceability Lot Code is the most important KDE across the CTEs and remains standard across the entire supply chain.

Traceability Plan – The description of procedures used to maintain records.

Why is Traceability Important?

Everyone remembers the notorious food recalls of the last decade, such as the e-coli outbreak at a large fast-food chain in 2016 or the baby food recall in 2022 that led to a nation-wide shortage. The average product recall can cost a company upwards of $10M per event, and that doesn’t include the cost of losing the trust of your customer base. Traceability tools and tactics allow organizations to work proactively against food risk and contamination, keeping their customers safe and maintaining a good reputation.

Apart from saving your organization from the natural consequences of a recall, the FDA will likely begin to implement penalties for companies that are not compliant with the FSMA 204 regulations by 2026. Those penalties could range from monetary fines to removal from partner networks or even being shut down by the FDA for repeat issues.

How Will FSMA 204 Impact Your Supply Chain?

Once the FDA deadline has been reached, all food supply chains will need to produce, maintain and keep record of KDEs for all CTEs throughout the supply chain. The FDA has established seven possible CTEs that you will be required to monitor. The CTEs are Harvesting, Cooling, Initial Packing of Raw Agricultural Commodities, First Land-Based Receiver, Transformation, Shipping, and Receiving.

Supply chain visibility

Having full visibility into your supply chain will be critical for maintaining compliance with FSMA 204. If your supply chain involves any of the items on the food traceability list, you will be responsible for implementing the necessary people, processes and technology that will provide visibility into each touchpoint in the supply chain.

Data monitoring and recording

Recordkeeping is one of the pillar responsibilities of FSMA 204. For items on the food traceability list, it will be important to have the right tools to monitor and record all key data elements across each critical tracking event.

Partner collaboration

This level of supply chain visibility and data monitoring is going to take dedicated collaboration and communication with each of your partners and vendors. From the farmer growing the food to the truck driver delivering it, each party will be responsible for tracking the KDEs in their particular CTE and recording them so they are visible to all key stakeholders.

Becoming FSMA 204 compliant can be a big undertaking depending on how many partners and vendors you work with and how much visibility, data monitoring and partner collaboration is already in place throughout your supply chain. enVista’s team of food supply chain experts and consultants is here to help every step of the way. Contact us today to learn how we can help you meet FDA requirements, strengthen brand trust and reduce company risk.