Zebra Technologies Corporation

11/29/2021 | Press release | Archived content

The FDA Has Defined a New “Blueprint for the Future,” and the Seafood Industry Must Act Now

This post was written by Chip Terry, Ph.D., CEO of BlueTrace, a Zebra Reseller.

The Food Safety Modernization Actis not new. Congress passed the law in 2011 to give the Food and Drug Administration (FDA) the ability to initiate mandatory recalls and a host of other powers over the food industry. In 2020, the FDA proposed a major update to the rules called "The New Era of Smarter Food Safety: A Blueprint for the Future." Although the final rules will not be published until 2022, the four core elements are clear:

  • tech-enabled traceability
  • smarter tools
  • food safety culture
  • new business models

There are lots of words and implications in the rules, and you can read more on the FDA website.

But the key update to note is Section 204 in which the FDA details its plans to "harmonize the Key Data Elements and Critical Tracking Events for enhanced traceability."The goal is to have end-to-end traceability that can enable tracebacks in seconds - instead of the current system that often fails and generally takes weeks. Here is our take on what this means for the seafood industry:

  1. Seafood gets special attention: The FDA ran risk models on what foods lead to the biggest food safety issues. All seafood (except scallop abductor muscles and catfish) ended up on the list along with leafy greens, eggs and numerous other products.
  2. New acronyms (KDE and CTE) get added to hazard analysis critical control point (HACCP) systems: For most distributors, the system will build on their existing HACCP program by mandating the tracking of Key Data Elements (KDEs) through Critical Tracking Events (CTEs).
  3. Digital data is required: The mandate is for nearly every food supply chain participant to provide a sortable spreadsheet to the FDA within 24 hours of request - essentially meaning that most companies must have a digital record to comply.
  4. Lot codes are key: Harvesters are required to put a unique identifier (lot code) on each harvest and that information should travel with the product through the supply chain.
  5. The first mile will be the hardest: Harvesters and growers are expected to collect and pass key information (including a lot code) about every harvest to the first buyer.
  6. Interaction with other regulations is unknown:Most notably the shellfish regulations which already require very similar information and tracking (minus the digital pieces).