I recently met with a USFDA Compliance & Enforcement Officer at a regional Institute of Food Technologists (IFT) networking event. Along with educating myself on new guidelines and collecting content related to safe food handling, preventive controls, and sanitary transportation, I asked a simple question out of curiosity… “What’s the single biggest compliance ruling that our F&B customers should be aware of?” The response was direct and quick. “If your clients aren’t already prepared for FSMA 204, they should be”, he replied without hesitation.
In short, the FDA most recent publication on Requirements for Additional Traceability Records for Certain Foods established new traceability requirements beyond current regulations for companies that manufacture, process, pack or store food and ingredients. This latest ruling is a key component of the FDA’s New Era of Smarter Food Safety Blueprint to implement FDA FSMA Section 204(d). In short, the new requirement will require faster identification of and quick remediation of potentially contaminated food from the marketplace. The requirement stipulates that subject companies must provide clear traceability data to the FDA within 24 hours or a reasonable amount of time otherwise defined by FDA.
Q. Does this apply to me?
A. If you manufacture, process, pack or store food and ingredients, this ruling probably applies to you.
Q. When is FSMA 204(d) compliance required?
A. Companies must comply by January 20, 2026 but not expect routine inspections until 2027 notwithstanding for-cause investigations.
Q. Is there a specific technology requirement for record keeping?
A. The FDA does not mandate nor certify individual technology solutions for safe record keeping. However, a modern ERP like Sage X3, designed to track and store parent-child (one-up, one-back) traceability from supplier to consumer precisely records the relational data for rapid retrieval to support recall notifications. For more best practices, learn how to Minimize the Embarrassment and Expense of Recalls with Sage X3 and watch the following videos on traceability and allergens.
Q. What should I do now?
A. It is your responsibility to become familiar with the requirements and qualifying exemptions. If you don’t already have one, it’s suggested that you begin documenting and implementing a traceability plan under 21 CFR Part 1 SubpartS.
For a complete list of frequently asked questions, visit the USFDA website dedicated to FSMA
204(d) for more information.
RKL eSolutions resells, implements and supports Food & Beverage companies powered by Sage X3, a modern ERP with industry-specific capabilities for process manufacturers. Our team of experts helps F&B companies optimize their Sage X3 software investment leveraging industry expertise and best practices that help companies meet GMP principles and FSMA compliance.
