A man in a warehouse checks his supply chain traceability in accordance with FSMA 204.

Fabiola Negron

Director of Food Safety

FSMA 204: How to Easily Maintain Supply Chain Traceability

Jul 17, 2023

With the Food Safety Modernization Act’s section 204 (FSMA 204), FDA intends to strengthen overall supply chain traceability within the food and beverage industry by mandating the tracking of certain food products.

Companies who have focused solely on their single link in the supply chain are now exposing their business to exceptional risks. It’s no longer simply about limited visibility into your supply chain and how you could hinder product quality, general safety, and erode consumer trust. Now the risk involves noncompliance with FDA and having greater risk of detentions, recalls, and shutdowns.  

However, with end-to-end visibility, supply chain traceability enables your product to be traced throughout the entire supply chain, ensuring compliance, quality, and reducing the risk of product defects and recalls. 

FSMA 204 Food Traceability Requirements 

If your company harvests, cools, manufactures, processes, packs, ships, or receives any of the foods outlined on the Food Traceability List, your business is now required to keep additional records on these items.  

These additional records are defined by FDA’s FSMA 204 as a set of metrics called Key Data Elements (KDEs), the most important being the new Traceability Lot Code (TLC) as it links a food product to each event in the supply chain. KDEs are gathered at specific Critical Tracking Events (CTEs) and depending on the complexity of your business, you may need to capture multiple sets of these KDEs.  

For instance, if you are a food processor, you might align as a receiver, a processor, and as a shipper since you would take product from a supplier and blend, repackage, relabel, or even transform the product before shipping the product to your customers. 

In addition to reporting these KDEs, FDA has also outlined these requirements: 

  • Businesses must create and maintain a traceability plan that includes the procedures for maintaining traceability records and how you identify foods on the Food Traceability List, how you assign lot codes, and a point of contact 
  • Businesses must also maintain records in paper, electronic, or true copies  
  • Provide traceability records to FDA within 24 hours after a request is made 
  • Provide a sortable spreadsheet with relevant traceability information to FDA within 24 hours of a request to assist during an outbreak, recall, or other public health threat

Gain deeper insights into the health of your entire supply chain with ComplyHub™.  

What’s Included in the Food Traceability List (FTL)? 

According to FDA, the Food Traceability List (FTL) identifies the foods that require additional traceability records. These additional requirements apply only to the foods listed on the FTL and — as long as the listed food is used as an ingredient that remains in the same form as it appears on the list — to the various foods that contain the listed items as ingredients. 

The FTL includes foods such as: 

  • Soft Cheeses 
  • Shell Eggs 
  • Nut Butters 
  • Fresh Herbs & Peppers 
  • Fresh Whole & Fresh-Cut Leafy Greens 
  • Fresh Cucumbers, Melons, & Tomatoes 
  • Fresh Tropical Tree Fruits & other Fresh Cut Fruits 
  • Fresh & Frozen Finfish, Crustaceans, and Molluscs  

Advantages of Tech-Enabled Supply Chain Traceability 

Imagine there’s an incident at a restaurant where the finished fish you supply has made several patrons sick. Tech enabled supply chain traceability systems make it possible to detect where contamination has taken place.  

By leveraging tech-enabled solutions, you can identify if the problem lies with the shipment of fish, if there was a failure in its conservation, or if it was a problem of contaminated animal feed at the source.  

Having this data readily available at a click of a button allows you to both quickly access situations and to remain compliant with FDA. You can even make informed decisions about how to proceed and even find replacement shippers and suppliers.  

Lack of Supply Chain Traceability Puts Your Business at Risk 

The last thing any business wants is to find out their suppliers aren’t in compliance when it matters most — during an outbreak investigation.  

With a software solution like ComplyHub™, you gain visibility into your entire supply chain. This not only safeguards you from various food safety risks, but it also helps you make better sourcing decisions, improving your supplier diversity. 

Discover how ComplyHub reduces your risk for recall by enabling visibility into your suppliers’ compliance status.


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

Related Article

Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.