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    November 4, 2022

    FSMA 204 COUNTDOWN: So what happens on November 7th?

    Guest blogger Julie McGill, Vice President of Supply Chain Strategy and Insights, shares insights leading up to the release of the Final Rule for FSMA 204. 

    FSMA 204 will be “published by November 7, 2022”. But what does that actually mean?

    FDA Rules and Regulations 

    As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the federal government's official publication for notifying the public of many kinds of agency actions. Federal regulations are either required or authorized by statute.  

    The final rule explains the regulatory requirements (also known as the "codified" portion), the impact of these requirements on the industry or the public, and responds to the comments on the proposed rule.  

    Once the FDA completes a proposed or final rule, but before it is published in the Federal Register, it may be reviewed by other parts of the federal government. In addition, they may consult with non-HHS agencies when working on a rulemaking that has a broader impact. For FSMA 204, the FDA engaged with various industry stakeholders, associations, and standards organizations. 


    The road to FSMA 204 the final rule has been a long one, and the publication date is in our sights. There have been several key steps that got us to this point: 

    September 23, 2020: The FDA published the proposed rule with requirements for additional traceability records for certain foods. 

    November 2020: The FDA held a series of virtual one-day public meetings to discuss the proposed rule, FSMA 204Requirements for Additional Traceability Records for Certain Foodsissued under the FDA Food Safety Modernization Act (FSMA), and to support the public's evaluation and commenting process on the proposed rule. 

    February 22, 2021: With the overwhelming response from the food industry, the public comment period for the proposed rule was extended until February 22, 2021.

    November 7, 2022: The final rule will be published by November 7, 2022. It will be made available to the public soon after in the Federal Register. 

    How Can I Learn More About the Final Rule? 

    FoodLogiQ is a proud sponsor of Food Safety Magazine's upcoming webinar, FDA's Tech-Enabled Traceability—New Standards to Improve Food System Transparency 

    This series features leading voices from FDA and industry and is the most in-depth series looking into the FDA's New Era of Smarter Food Safety both inside and outside the FDA. The second in this webinar series focuses on Core Element 1 of the New Era blueprint, tech-enabled traceability, as well as the contents of the final Traceability Rule, FSMA 204

    During this webinar, you will hear about the envisioned future of food traceability with the creation of standards, as well as other work by the FDA to advance traceability as part of the New Era of Smarter Food Safety. Speakers include Frank Yiannis, Cpt. Kari Irvin and Katherine Vierk from the FDA, Angela Fernandez from GS1 US, and Ed Treacy from the International Fresh Produce Association (IFPA).  

    The webinar will be held on November 29, 2022, at 2 pm EST. Sign up for this free event.  

    What You Need to Know About FSMA 204 Compliance

    FSMA 204 compliance will require process and operational changes, rigorous data collection, and collaboration with your supply chain partners. Having a solution in place to manage all of this, and ensure compliance is key to your success. 


    1. Tech-Enabled traceability is essential for competitive food businesses and provides business value beyond compliance and consumer protection
    2. Companies are at risk if they do not understand their role and approach to capturing and sharing enhanced traceability data for high-risk foods
    3. The proposed traceability timelines are feasible with aggressive action on the planning and development of digital traceability programs
    4. Advanced traceability record keeping is here to stay, this is only the beginning

    We are the leading industry experts in tech-enabled food traceability and your first choice for FSMA 204 compliance support. If your organization is looking for a platform to streamline your workflow, implement corrective actions, or centralize required recordkeeping, reach out to our experts at FoodLogiQ today. 

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