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New FDA Requirements for Traceability


Last month, new FDA requirements for traceability were proposed by the agency to expand data collection for manufacturers who process foods that are known to be at a particularly high-risk for foodborne illnesses and quality issues. These foods are defined on their “Food Traceability List”, created in 2014 in an effort to create a centralized list of risk prone food categories. The standards put forth by the agency, which fall under the broader Food Safety Modernization Act (FSMA), would require manufacturers to produce and maintain records on “Key Data Elements” related to different “Critical Tracking Events” throughout the production, storage, and shipping processes.

What is a KDE/CTE?

The FDA’s proposal is built around the collection of Key Data Elements (KDEs) and Critical Tracking Events (CTEs), but what exactly do these two terms mean? CTEs are major steps along the production process where food is moved or changed in some way. The proposal identifies 5 in total: growing, receiving, creating, transforming, and shipping. KDEs would then be different data points relating to each of the 5 CTEs. For example, some of the KDEs required to be recorded under receiving are quantity/unit of measure, location identifiers, and traceability lot codes. In this way, KDEs can be thought of as subsections of CTEs, sort of like chapters in a book or pieces in a puzzle.

What’s Included on the FTL?

The foods featured on the Food Traceability List are those that have been found to be at particularly high risk of contamination, foodborne illness, or safety issues. While the full list can be found by clicking here, some notables include:

  • Produce such as melons, peppers, and sprouts
  • Soft cheeses
  • Finfish & crustaceans
  • Ready-to-eat salads

If your product line currently features any of these items, or any of the items on the list, these rules will apply to you first.

How will the new FDA Requirements for Traceability Affect Processors?

At the time of writing, the new FDA requirements for traceability would only apply to food manufacturers who process foods found on the FTL. However, the rules have been designed with the future in mind and could apply to processors in any food industry vertical. Those affected by the rule would likely see increased strain on their record keeping systems, especially if they’re handling those processes manually or are unused to managing and tracking such a large amount of production data. It is also worth noting that exceptions are made within the proposal for those operating with certain business models or under specific conditions. While these exceptions are too specific to detail in this post, you can check whether your business might be exempt under the “Exemptions and Modified Requirements” section on the FDA’s official release.


With traceability and safety standards getting stricter nearly every year, there’s no better time to get ahead of compliance requirements than now! Contact ParityFactory today, and we’ll show you how to future-proof your operation.


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