In FDA-regulated industries, a single event can lead to widespread change. For example, the 1982 tragedy involving Tylenol laced with potassium cyanide changed the way we look at product safety. Decades later, everything from eye drops to guacamole have tamper-evident seals, largely resulting from that crime. With no shortage of issues in food safety news today, it’s clear why new FDA traceability rules are coming down the pike.

For instance, crises involving E. coli outbreaks in romaine lettuce and Salmonella in peanut products are among many examples where food traceability was a critical challenge in protecting consumers. Not surprisingly, the FDA is now using the Food Safety Modernization Act (FSMA) to tackle traceability for these and other foods. The new FDA traceability rule is part of the agency’s New Era of Smarter Food Safety, which focuses on using digital tools to reduce food-borne illness.

What can you expect in the new regulations, and what should food and beverage companies be doing now to prepare? This article looks at the details of the new FDA traceability rule going into effect and what companies must do to ensure compliance.

What’s in the New FDA Traceability Rule?

The FDA is proposing new traceability requirements under FSMA for anyone who manufactures, processes, packs, or holds perishable items on the agency’s Food Traceability List which includes:

  • Soft cheeses
  • Eggs
  • Nut butter
  • Cucumbers
  • Herbs
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Finfish such as cod, mackerel, salmon and others
  • Crustaceans, mollusks and bivalves
  • Ready-to-eat deli salads

While the new rule only applies to these foods, the FDA notes it was designed for all regulated foods. Therefore, the agency recommends that all food companies adopt the traceability rules voluntarily.

Critical Tracking Events (CTEs): For all listed foods, companies must keep records of associated with Critical Tracking Events (CTEs). The FDA has identified five CTEs covering each step in the supply chain:

  • Growing
  • Receiving
  • Transformation
  • Creation
  • Shipping

Key Data Elements (KDEs): Furthermore, companies must keep records of Key Data Elements (KDEs) associated with each CTE. Companies must track different KDEs depending on the event, and include data points such as:

  • Growing area coordinates
  • Location identifiers and descriptions
  • Date and time the event happened
  • Quantity affected
  • Lot codes
  • Traceability product identifiers
  • Reference record types and numbers

The FDA has created an interactive guide to illustrate examples of CTEs and KDEs throughout the supply chain. KDEs are based on the type of business and have different requirements for each.

Timing of New FDA Traceability Rules

The FDA proposed the new rule in January 2021, with the public comments open until February 22, 2021. The Final Rule is expected in late 2022, and will include a two-year transition period for implementation. After that point, manufacturers must comply with all requirements.

For food companies, the amount of data that must be tracked is going up dramatically. Systems to track this massive volume of data can’t be built overnight. Consequently, companies utilizing spreadsheets and siloed systems need to start planning now.

Recently issued draft guidance on FDA Oversight of Food Products Covered by Systems Recognition Arrangements also highlights the importance of traceability. A systems recognition arrangement (SRA) is an agreement between FDA and a regulatory counterpart in another country where food safety monitoring offers a similar level of protection. These agreements are based on systems recognition assessments where traceability plays a key role.

What Food Companies Should Be Doing Now

First and foremost, companies need to educate themselves on the new Food Traceability Proposed Rule. Individual requirements vary according to the type of food and location in the supply chain.

Next, manufacturers need to think about how they will manage all of their traceability data. In addition to the new requirements listed above, the FDA requires companies to keep records of the traceability program itself, such as:

  • Description of reference records: Where KDEs are tracked, for instance, purchase orders and production logs, where traceability information is on these records with established linkages
  • Food Traceability List (FTL): Foods shipped by the company, including product identifier and description
  • Description of how a company assigns traceability lot codes used to identify it within the supply chain

Furthermore, the rule is applicable not only to foods specifically listed on the FTL, but also to foods that contain foods on the FTL list as ingredients.

These records must be provided to the FDA within 24 hours of a request by the agency. Meeting this short timeline creates an urgent need for real-time tracking, reporting, and corrective action for incidents and events due to the distribution and shelf life of products. Given the scope of the requirements, companies may want to add a dedicated position to manage compliance.

Finally, companies will need a configurable enterprise quality management system (EQMS) to track this volume of data and make sure nothing falls through the cracks. Clearly, paper records will be inadequate and even spreadsheet-based tracking will be unwieldy. Conversely, an EQMS makes it easy to access records, protect data integrity and speed up communication with regulators. All in all, this leads to a higher level of trust in food safety and the supply chain.

EQMS Solutions to Leverage for FDA Compliance

Within the context of the new FDA traceability rule, food companies will need a specific set of tools within the EQMS. Each of these solutions should communicate and share information to expedite and record event/incident tracking, investigation and remediation.

These include:

In addition, mobile-ready solutions will also play a key role in preparing for the new rule in terms of conducting and verifying your processes. Being able to pull up EQMS records from a tablet or phone will be important for activities like receiving product, conducting supplier audits, and preparing for FDA audits.

Other tools such as barcode development can help improve traceability of foods throughout the supply chain, revealing the entire history of a food with a simple scan. In the future, even more advanced tools like blockchain will likely emerge as key weapons in the fight. Implementing an automated EQMS with robust industry integrations will make these systems far more effective compared to using spreadsheets to manage food safety.


Identifying and remediating the source of food-borne illnesses and protecting public health all comes down to traceability. Therefore, it’s no surprise the FDA is ramping up its requirements under FSMA. Accordingly, companies need to start working now to understand the new rule and the quality processes they need to put in place along the supply chain. As with any proactive safety model, laying the groundwork with data collection strategies in a digital EQMS is the most practical and to smooth the transition. A quality management system that ties all relevant data improves issue management and compliance in a way that demonstrates a commitment to public health and improves competitiveness in the marketplace.

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