Editor's note: The final rule for FSMA Section 204 was published in November 2022. Read our full assessment and how you can get ready for compliance on our FSMA 204 Final Rule blog post.
There has been a lot of chatter within the food industry about the Food Safety Modernization Act (FSMA), Smarter Food Safety, and the complex forthcoming FDA requirements that will fall under the umbrella of traceability regulation. It’s more important than ever to be gaining understanding around the key concepts driving food safety innovation and the next wave of recordkeeping requirements. For those looking to get a cursory understanding of the current landscape, FoodLogiQ has gathered key resources for understanding the state of FSMA and Traceability in 2021.
FSMA and Traceability: An Overview
The FDA’s Food Safety Modernization Act (FSMA) is a piece of United States federal legislation that was ratified in 2011 by President Obama. FSMA has since served as the primary regulatory framework for food safety and consumer protections for the industry, articulating rules for smarter prevention and response throughout the food system.
Food traceability is covered under FSMA Section 204, “Enhancing Tracking and Tracing of Food and Recordkeeping.” Under FSMA Section 204, the FDA was required to conduct pilot programs, access global standards and further develop recordkeeping requirements, particularly for food products deemed as high risk.
In September 2020, the FDA published a proposed rule for traceability, in accordance with FSMA section 204 (the Final Rule was published in November 2022). The recordkeeping requirements outlined within the rule will establish a broader foundation for food traceability, starting with recordkeeping requirements for designated foods from creation, transformation, processing, packing, shipping and more.
FDA Webinar: Requirements for Additional Traceability FSMA Section 204
In a recorded webinar by the FDA, Deputy Commissioner for Food Policy and Response Frank Yiannas discussed the value of the proposed traceability rule for the food industry, who may be affected, in addition to what the suggested requirements entail.
The FDA’s Approach to Traceability
In order to gain a better understanding of FSMA and the new proposed traceability rule, it is imperative to understand another initiative the FDA is leading, the New Era of Smarter Food Safety. The strategies and focus areas outlined in the initiative blueprint include Tech-Enabled Traceability, which will be a driving force behind the approaches being taken to articulate new requirements.
Learn more about the FDA’s approach to traceability from a regulatory and and industry leadership perspective:
- Proposed Traceability Rule Overview: The FDA has formally released the proposed traceability rule for FSMA section 204. Learn how the drafted legislation may apply to your own food safety, data and product tracing programs.
- Understanding Traceability Events: Minimum requirements for the capture and storage of CTEs are evolving, learn about what constitutes a Critical Tracking Event or Key Data Element.
- Food Traceability List: FSMA section 204 requires the FDA to methodologically determine which foods are high risk, and set recordkeeping requirements for products affected. Learn about the FDA’s approach and the proposed foods on the initial list.
- Traceability in the New Era of Smarter Food Safety: What do we mean when we talk about traceability? As the industry moves beyond one-up-one-back product tracking, how will we define and standardize transparency within the food system?
The FDA’s FSMA Traceability Glossary
In accordance with the FSMA section 204 rule proposal, the FDA has released the following glossary of terms. These key terms provide an important framework for understanding food traceability regulation under FSMA, and are strong entry point into understanding key traceability concepts. See the full list of terms within the proposed rule document here.
Preparing for Traceability 2.0
Learn how you can evolve your traceability program for the New Era of Smarter Food Safety, by reaching out to the FoodLogiQ team. Our experts can help you understanding the key steps major brands need to take in preparation for supply chain transparency and new regulation.