U.S. regulators want a more robust, technology-driven approach to traceability and safety in the food supply chain. Their strategy has several components, but the FSMA traceability requirements published in November 2022 should be top-of-mind for the food industry in the United States and elsewhere.
Let’s take a look at the Food Safety Modernization Act (FSMA) and FSMA traceability requirements. Even though the compliance deadline is about three years away, now is the time to start planning your strategy.
FSMA implementation and goals
The Food and Drug Administration (FDA) is the primary implementing regulatory agency of FSMA, a law that seeks to transform the United States’ food safety system “by shifting the focus from responding to foodborne illness to preventing it.” It focuses on five areas:
- Preventive controls
- Inspection and compliance
- Imported food safety
- Response (i.e., recalls)
- Enhanced partnerships
In terms of FSMA traceability, the regulations address the “need for rapid and effective tracking and tracing of foods.”
FSMA Section 204 and the three pillars of FSMA traceability
Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:
- Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
- Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
- Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.
Today, we’re going to focus on Nos. 2 and 3, which concern the FDA’s Food Traceability List and the Final Rule on Requirements for Additional Traceability Records for Certain Foods (“Final Rule”).
The Food Traceability List and the Final Rule
The Food Traceability List (FTL) was developed with input from a 2014 Request for Comments and for Scientific Data and Information in the Federal Register, members of the FDA and the Centers for Disease Control and Prevention, and external subject matter experts. It includes “high-risk foods” such as leafy greens, shell eggs, crustaceans (e.g., shrimp, crab, lobster), and finfish (e.g., cod, tuna, salmon).
In September 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods.” Known as the “Food Traceability Proposed Rule” or “Proposed Rule,” it defined additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FTL.
After making modifications and holding a period for public comments, The FDA in November 2022 announced the Final Rule on Requirements for Additional Traceability Records for Certain Foods.
The gist of the Final Rule and FSMA traceability is that businesses are responsible for establishing and maintaining records of critical tracking events (CTEs) and associated key data elements (KDEs).
CTEs are typically events that occur during growing and processing (e.g., harvesting, initial packing, and shipping). KDEs provide the granular details for FSMA traceability, such as time, location, unit measurements, and a company’s contact information.
The information companies must keep and share with their partners depends on the type of supply chain activities they perform with respect to food(s) on the FTL. The activities encompass the entire food supply chain, from harvesting or production, to processing, distribution, and receipt at a retail location or other point of service.
The FDA says this “framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.”
The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.
The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.
This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.
And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.
Read more about FSMA:
- Download our new white paper: Traceability in the Food Supply Chain
- FSMA Traceability Requirements: FDA Guidance & GS1 Standards
- FSMA 204 Data Carrier: FDA Guidance and GS1 Standards
- What is the FSMA Traceability Lot Code and Who Must Comply?