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FDA proposes strict traceability rules for some food products


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

The ability to trace where food originally came from allows officials to better control and manage contamination when it does occur. Recently, the Food and Drug Administration (FDA) 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 update to the existing rules.

Why update?

The original 2011 law mandated that certain requirements be met under the FDA Food Safety Modernization Act (FSMA) to allow for proper food tracing and record keeping. However, in September 2020, the FDA issued 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 section 204 rule?

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

What is the main purpose of the new requirements?

The revised FDA tracking requirements are intended to prevent or better reduce foodborne illness outbreaks by strict record keeping that will enable end-to-end traceability.

Requirements will be mandatory:

  • How traceability records are to be maintained.
  • That a company is able to provide traceability records within 24 hours of the request.
  • This record and data are well maintained and easily sorted into an electronic spreadsheet to determine the source of an outbreak and to assist with product recalls or other public health hazards or threats. is.

Technology will ease the tracing process

The lack of data to track 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 more tech-enabled traceability systems for certain foods will also help it maintain more accurate records.


Your customers do not expect issues that could result in product recalls. But if it does, they may be surprised to learn that most commercial general liability policies will not provide insurance coverage for a recall event.

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

  • Removal / recall / destruction of contaminated products.
  • Engagement of damage control consultants/experts.
  • Prolonged business interruption due to partial or complete shutdown of operations.
  • Third-party bodily injury claims from consumers.
  • Property damage costs incurred when a contaminated product becomes an ingredient in another product.

On worldwide facilitiesWe have the expertise and markets to provide comprehensive product recall insurance to help put your customers on the path of 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 dfiske@wwfi.com, or Lori Hunter (213) 236-4585 or . On lhunter@wwfi.com.

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Disclaimer: The opinions expressed within this article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of knews.uk and knews.uk does not assume any responsibility or liability for the same.

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