FSMA 204 is FDA’s Best Chance at a Winning Bracket

April 7, 2025by Andy Kennedy

As I watched AI evaluate my NCAA Basketball Tournament bracket last month, I was reminded of an FDA foodborne illness traceback or whole genome sequence analysis. FDA experiences March Madness every month, starting with quite a few “teams” that must be evaluated. Often, FDA isn’t given the benefit of helpful “rankings” to make decision-making easier – much of the data they receive when dealing with an outbreak is in the form of scanned documents without lot codes or sources, even if they get the data they asked for at all. As a food industry, how could we increase the odds that FDA’s brackets are better than my random predictions on who will win? Upon request, could we quickly provide FDA investigators with accurate lot-code and source-specific electronic traceability data?

 

To cite a recent example, on January 8, 2025, the CDC declared an end to a Salmonella outbreak linked to cucumbers from Sonora, Mexico, which seriously sickened at least 113 people across 23 States and impacted dozens of products, brands, and retailers, including Walmart, Kroger, and Costco. The outbreak began on October 12, 2024, continued through early December, and was declared over in January based on the shelf life of the contaminated products. Recalls only started 46 days after the beginning of the outbreak, meaning that contaminated foods could have been on store shelves for over two months.

More Effective, Efficient Investigations Require Source-Specific, Digital Data

This investigation and recall could have been faster and more effective with timely, digital, source-specific, lot-based traceability data. FDA published the FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (FSMA 204) to the Federal Register in November 2022 – over a decade after the Food Safety Modernization Act was signed into law. Recently, FDA extended the January 2026 enforcement date by thirty months to allow the industry more time to comply. As an industry, we can and should help FDA more accurately and efficiently complete a winning bracket sooner than the middle of 2028.

We’re all in this together – quicker and more accurate identification of the source of contamination during an outbreak means protecting consumer health, financial losses, food waste, and your brand.

Andy Kennedy

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