Articles
December 01, 2022
FDA’s new food traceability regulation overly burdensome for restaurants
Record-keeping requirement considered a game-changer takes effect January 2026
According to the U.S. Centers for Disease Control and Prevention (CDC), 48 million people get sick from foodborne illnesses each year.
Tasked with protecting and promoting public health, the Food and Drug Administration's scope and enforcement powers were expanded to strengthen the food safety system in 2011 when President Obama signed into law the Food Safety Modernization Act. Shifting from a decades-old reactive system—investigating incidents after the fact—to one built to prevent problems from occurring takes time and will impact businesses beyond food manufacturers.
FDA’s recent final rule “Requirements for Additional Traceability Records for Certain Foods” requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain and provide certain data to their supply chain partners for critical tracking events (CTEs) in the food's supply chain.
Items on the FTL include fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products. A complete list can be found here.
While government officials believe the regulation will help notify the public earlier about recalls and remove contaminated or potentially contaminated food more quickly from the marketplace, it’s raising concerns across multiple industries in which small businesses play a vital role.
Now considered “covered entities,” restaurants must comply with the regulation by providing traceability information to the FDA within 24 hours of an official request, or within some reasonable timeframe to which the FDA agrees. Restaurants are also required to keep records containing the traceability lot code upon receipt of an FTL food to help determine what lots were available for purchase or consumption during the exposure timeframe.
Some restaurants making less than $250,000/year are exempt from the recordkeeping requirement, but others making slightly more than that—who do not have personnel or resources to maintain exhaustive records—are likely to be disproportionately affected.
FDA is not just concerned with obtaining the data, but also how the data is maintained.
Businesses must provide a sortable, electronic spreadsheet containing information FDA requests on CTEs involving particular FTL foods to be able to access date ranges or traceability lot codes specified in a request. Certain smaller entities are exempt from the requirement to provide this information in a sortable, electronic spreadsheet, though they must still provide the information in other electronic or paper form.
Larger restaurants must keep records but some are exempt from compiling the information in a sortable spreadsheet. For large restaurants that have sold or provided food amounting to an average of no more than $1M during the previous 3 years, the sortable spreadsheet requirement does not apply.
Restaurants must comply by January 20, 2026. However, FDA is giving businesses subjected to the rule an additional 2-3 years grace period during which the agency will provide training and guidance.
FDA will be leading a webinar for businesses affected by the new regulation on Wed., Dec., 7; register to attend. In the coming weeks, the Association will release additional resources and conduct its own webinar specifically on requirements for restaurants.
For questions or more information, contact Association Director of Food and Sustainability Laura Abshire.
Tasked with protecting and promoting public health, the Food and Drug Administration's scope and enforcement powers were expanded to strengthen the food safety system in 2011 when President Obama signed into law the Food Safety Modernization Act. Shifting from a decades-old reactive system—investigating incidents after the fact—to one built to prevent problems from occurring takes time and will impact businesses beyond food manufacturers.
FDA’s recent final rule “Requirements for Additional Traceability Records for Certain Foods” requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain and provide certain data to their supply chain partners for critical tracking events (CTEs) in the food's supply chain.
Items on the FTL include fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products. A complete list can be found here.
While government officials believe the regulation will help notify the public earlier about recalls and remove contaminated or potentially contaminated food more quickly from the marketplace, it’s raising concerns across multiple industries in which small businesses play a vital role.
Now considered “covered entities,” restaurants must comply with the regulation by providing traceability information to the FDA within 24 hours of an official request, or within some reasonable timeframe to which the FDA agrees. Restaurants are also required to keep records containing the traceability lot code upon receipt of an FTL food to help determine what lots were available for purchase or consumption during the exposure timeframe.
Some restaurants making less than $250,000/year are exempt from the recordkeeping requirement, but others making slightly more than that—who do not have personnel or resources to maintain exhaustive records—are likely to be disproportionately affected.
FDA is not just concerned with obtaining the data, but also how the data is maintained.
Businesses must provide a sortable, electronic spreadsheet containing information FDA requests on CTEs involving particular FTL foods to be able to access date ranges or traceability lot codes specified in a request. Certain smaller entities are exempt from the requirement to provide this information in a sortable, electronic spreadsheet, though they must still provide the information in other electronic or paper form.
Larger restaurants must keep records but some are exempt from compiling the information in a sortable spreadsheet. For large restaurants that have sold or provided food amounting to an average of no more than $1M during the previous 3 years, the sortable spreadsheet requirement does not apply.
Restaurants must comply by January 20, 2026. However, FDA is giving businesses subjected to the rule an additional 2-3 years grace period during which the agency will provide training and guidance.
FDA will be leading a webinar for businesses affected by the new regulation on Wed., Dec., 7; register to attend. In the coming weeks, the Association will release additional resources and conduct its own webinar specifically on requirements for restaurants.
For questions or more information, contact Association Director of Food and Sustainability Laura Abshire.