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FDA Proposes Stricter Traceability Rules for Certain Food Products

This post is part of a series sponsored by Worldwide Facilities, LLC.

The ability to trace where food originally came from allows authorities to better contain and manage contamination when it occurs. Recently, the Food and Drug Administration (FDA) has suggested implementing additional traceability recordkeeping requirements that go above and beyond existing regulations for operations that manufacture, process, pack or hold foods. Here’s what your clients need to know about the proposed updates to existing rules.

Why the Update?

The original 2011 legislation mandates that certain requirements be met to allow for proper food traceability and record keeping under the FDA Food Safety Modernization Act (FSMA). However, in September 2020, the FDA released a proposed rule aimed at improving the traceability of farm-to-table foods under FSMA Section 204 to help address food safety risks.

What is the Section 204 Rule?

Simply put, the rule defines the enhanced recordkeeping requirements regarding the tracking and tracing of food products. It includes additional traceability requirements proposed by the FDA and focuses on certain foods that are named in the Food Traceability List (FTL) that may be considered a higher risk for contamination. All food products on the FTL, as well as food products containing ingredients named on the list, are subject to the new requirements.

What’s the Main Objective of the New Requirements?

The objective of the revised FDA tracking requirements is to prevent or better mitigate foodborne illness outbreaks by imposing stricter record keeping that will enable end-to-end traceability.

Requirements will mandate:

  • How traceability records are to be maintained.
  • That a company be able to provide traceability records within 24 hours of a request.
  • That records and data be well maintained and easily sorted in an electronic spreadsheet to quickly determine the source of an outbreak and to assist with a product recall or other public health hazard or threat.

Technology Will Make the Tracing Process Easier

The lack of data for tracking specific products through the supply chain has been a challenge for the FDA. For the new tracking system, the FDA is looking at developing standardized data elements that will facilitate access to information sent to the next entity in the supply chain. The FDA hopes that leveraging digital capabilities in a more tech-enabled traceability system for certain foods will also help it maintain more accurate records.


Your clients don’t expect issues that could result in a product recall. But if it does happen, they may be surprised to learn that most commercial general liability policies won’t provide insurance coverage for a recall event.

The fact is, a product contamination event can be costly, resulting in expenses associated with:

  • The removal/recall/destruction of contaminated products.
  • Having to hire damage control consultants/experts.
  • Prolonged business interruption due to a partial or full shutdown of operations.
  • Third-party bodily injury claims from consumers.
  • Property damage costs in the event a contaminated product becomes an ingredient in another product.

At Worldwide Facilities, we have the expertise and markets to provide your clients with comprehensive product recall insurance to help them get on the road to financial and reputational recovery. To learn more about our products and services, or for coverage questions, please contact David Fiske at (312) 465-5305 or, or Lori Hunter at (213) 236-4585 or

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