FSMA Section 204: Are You In Compliance?

When to expect enforcement for policy change- set up your cold storage facility/warehouse to avoid fines.

In the dynamic realm of supply chains, the winds of change blow stronger than ever before. As we navigate through 2024, understanding what these changes mean for your farm, warehouse, or cold storage facility is crucial with the upcoming policy changes. The FDA has announced the Food Safety Modernization Act (FSMA) with a set deadline for January 20th, 2026. Section 204 of this act requires businesses to provide records that track their products through the entire supply chain. Adapting to these FSMA Section 204 standards is not just a smart move; it’s a necessary strategy for survival in an ever-evolving marketplace.

Utilize the FDA’s traceability exemption flow chart.

If you worry your business can be affected by FSMA Section 204, look no further. The FDA has created a tool called the Traceability Exemptions Flow Chart. This tool can be used to determine if your business is exempt from having to meet these regulatory changes. How one documents the information for the products on the Food Traceability List (FTL) is up to them. However, the FDA does specifically say what information needs to be included in the documentation. This plan is a summarization on how to assign lot codes and how to track your products. Ensuring that your business is in compliance before the 2026 deadline will ultimately cut down on the stress of scrambling to avoid fines from the FDA or inspection companies. The potential of being shut down exists.

When developing your traceability plan, it’s essential to include specific details outlining procedures for maintaining required records and their storage locations. Additionally, detailed procedures for identifying foods on the FTL, encompassing manufacturing, packing, and processing stages. This involves outlining how lot codes are assigned, especially for growers, specifying locations and other pertinent geographic information. Any modifications to the traceability plan must be documented, with the previous plan retained for two years following updates. This new compliance plan will help cut down the time and costs if the FDA finds reason to investigate in the event of a contamination.

Key elements of a traceability plan.

Businesses will need to provide two packets of information with their products. FSMA Section 204 requires Critical Tracking Events (CTEs) and Key Data Elements (KDEs) to be recorded. CTEs are events happening along the supply chain that need to be recorded. The KDE is the specific information that needs to be included in the records over events that happened. Identifying the CTEs that apply to your supply chain will determine the required KDEs. For example, ingredients (i.e. tomatoes, carrots and onions) that are ordered for your products will arrive with KDEs. If these are used to make your final product (i.e. a deli salad) then your finished product will need to have a receiving record of those ingredients, not their KDEs. However, there are some ingredients that might go into your final product that you will not have to keep records for. It depends on if they are on the FTL. Keeping these incoming ingredient records and the outgoing product records can cut down on chargebacks. 

The last piece of key information needed in traveling records is the Traceability Lot Code included on the KDE list. These lot codes are descriptors uniquely created to identify a traceability lot. This info will follow the product throughout the entire supply chain until it is sold. This information will help the FDA quickly identify points of transformation in the case of contamination. To prepare for the 2026 deadline, consider reviewing your current records and identify where CTEs and KDEs might be needed for the new Food Traceability Plan.

Prepare your business with the essential technology for easy data capture.

With FSMA Section 204 comes new standards and regulations. Embracing compliance isn’t just about meeting requirements; it’s about positioning yourself competitively and ensuring long-term viability. We’re here to help you navigate these changes. By investing in technology, enhancing data connectivity, and prioritizing adaptability, you can future-proof your operations and thrive in a dynamic marketplace. Do not wait for the wave of change to overwhelm you. Embrace it proactively and reap the rewards- be a leader in the industry. Together, we can overcome challenges, seize opportunities, and chart a course for sustained growth and success.

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