FDA’s Food Traceability Final Rule: What Restaurants Need to Know

Oct 01, 2023

The FDA’s Food Traceability Final Rule establishes new recordkeeping requirements for those involved in producing and handling of specific foods listed on the Food Traceability List (FTL). This rule, part of the New Era of Smarter Food Safety Blueprint and the FDA Food Safety Modernization Act (FSMA) aims to enhance food safety by enabling quicker identification and removal of potentially contaminated products from the market.


Does this Rule Apply to Restaurants?

Starting January 20, 2026, restaurants must adhere to new food traceability rules for specific items listed on the Food Traceability List. These items include fresh fruits, vegetables, shell eggs, nut butters, cheeses, and seafood products. Restaurants must keep records detailing the origins of these food products. They will have to track Key Data Elements (KDEs) related to Critical Tracking Events (CTEs), primarily focusing on received goods and food products. Suppliers are expected to collaborate with restaurant operators to facilitate compliance, although this may increase costs for restaurants.

Restaurants will be required to maintain records showing essential information about traced items, such as their source, acceptance date, traceability lot-code source information, and reference document data. Additionally, restaurants must develop an electronic traceability plan outlining their record-keeping procedures. In the event of a foodborne illness outbreak, restaurants must be prepared to provide requested traceability records to the FDA within 24 hours or within an agreed-upon reasonable timeframe.

The new rule applies to all restaurants that sell food and beverages totaling over $250,000 annually, impacting most small restaurants. Restaurants selling between $250,000 and $1 million may have different reporting requirements and may not need electronic records but can submit receipts and invoices. Restaurants with over $1 million in annual sales will be mandated to maintain electronic records. The restaurant industry will continue to work with the FDA to ensure smooth implementation of the Food Traceability Rule, providing operators with the necessary information for compliance.

fda food final rule

Preparing for the Food Traceability Rule

As the 2026 compliance date approaches, the food industry must take several steps to prepare to implement the new food traceability rule. Firstly, firms should thoroughly understand the rule, its applicability to their specific businesses, and whether any total or partial exemptions are relevant. They should also identify the critical tracking events they are involved in and the required Key Data Elements (KDEs). Some businesses may have multiple critical tracking events to manage.

Secondly, companies should assess their existing data and data management systems to determine what information they currently possess and receive from their supply chain partners. This includes evaluating their internal data systems.

Thirdly, firms must initiate discussions with their supply chain partners to ensure a mutual understanding of compliance requirements. Questions to address include whether contract amendments are necessary to ensure data sharing among partners, the methods for sharing data, and how to support smaller suppliers, including foreign entities, in meeting their obligations under the rule.

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