What is the Food Traceability List?

Food businesses across the United States are readying themselves for FSMA 204, the Food Traceability Rule. If you are unsure of whether or not this rule applies to you, the best place to start is with the Food Traceability List.

The Food Traceability List is a list of high-risk foods for which additional traceability recordkeeping is required. Foods on the list are judged to be at higher risk of contamination. This includes certain cheeses, eggs, nut butters, fresh produce, seafood, and ready-to-eat deli salads. 

The Food Traceability List is a central part of the FDA’s Food Traceability Rule (FSMA 204). Organizations who manufacture, process, pack, or hold foods on the Food Traceability List are required to carry out additional food traceability recordkeeping. These additional responsibilities are being brought in to increase the safety and transparency of the country’s food supply chain. By enforcing additional food traceability requirements, the FDA is making it easier to identify the source of the contamination in the event of a foodborne disease outbreak. If an outbreak were to occur, the affected batch of food can be recalled more effectively to prevent further spread.

Additional recordkeeping responsibilities apply to:

                      • Foods specifically listed on the Food Traceability List.
                      • Foods that contain listed foods as ingredients, provided that they remain in the same form (e.g. fresh) as they appear on the list. 

The FDA has included the following foods on the Food Traceability List: cheeses, shell eggs, nut butters, cucumbers, herbs, leafy greens (fresh and fresh-cut), melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits, fresh-cut vegetables, finfish, smoked finfish, crustaceans, molluscan shellfish, and ready-to-eat deli salads. 

You can review the full list, with definitions and exemptions here.

Are There Any Exemptions? 

Even if you manufacture, process, pack, or hold foods on the Food Traceability List, there are exemptions. To help you determine if the rule applies to your business, the FDA has created an incredibly useful online exemptions tool. 

Try out the exemptions tool here. 

Why is Stopping Foodborne Outbreaks So Important?

The CDC (Centers for Disease Control and Prevention) estimates that approximately 48 million people get sick from foodborne diseases each year in the United States, with 128,000 hospitalized, and 3,000 deaths.

Apart from the severe health consequences, the cost of contamination in our food supply can be enormous on those in the food industry. Between 2011 and 2022 there were over 9,000 reported foodborne illness outbreaks across all 50 states (according to CDC data). Outbreaks often attract a huge amount of negative publicity and can have a significant impact on brand reputation and consumer confidence. This can lead to decreased sales and financial loss. The reputational damage can be long-lasting and incredibly difficult to repair. 

In 2023, the estimated cost of foodborne illness in the United States was $75 billion. Deaths accounted for 56% and chronic outcomes for 31% of the mean cost. The costliest pathogen was nontyphoidal Salmonella at $17.1 billion followed by Campylobacter at $11.3 billion (source). 

Why Have Certain Foods Been Identifed as ‘High Risk’?

Foods on the Food Traceability List are judged to be ‘high-risk’ foods. This is based on a risk-ranking model developed by the FDA in conjunction with an FDA Project Advisory Group (PAG), consisting of members from the FDA and the CDC. The model is designed to be flexible and to consider a wide range of known and reasonably foreseeable contaminants in FDA-regulated human foods. 

Factors considered in the risk-ranking model include:

                      • Frequency of outbreaks and occurrences of illnesses.
                      • Severity of illness.
                      • Likelihood of contamination.
                      • The potential for pathogen growth, with consideration of shelf life.
                      • Manufacturing process contamination probability and industry-wide intervention.
                      • Consumption rate and amount consumed.
                      • Cost of illness.

The FDA has developed a tool designed to allow users to explore the results of the risk-ranking model used in the development of the Food Traceability List.

Updates to The Food Traceability List

The Food Traceability List will be updated every five years. When updates are made, they will be published in the Federal Register stating the proposed changes and the reasons for them. The FDA will then solicit feedback and public comment before finalizing the change. Once finalized, additions will come into effect two years after the date of the second Federal Register notice, unless otherwise stated.  

Any deletions from the FTL are effective immediately.

Does Your Business Need to Comply?

Find out by reviewing the food products and list of exemptions on the Food Traceability List.