Industry Responds to FDA Produce Traceability Rule

NACS is concerned the proposed rule would negatively impact smaller convenience retail operations.

February 25, 2021

ALEXANDRIA, Va.—NACS submitted comments to the U.S. Food and Drug Administration (FDA) on its proposed new rule to establish additional traceability recordkeeping requirements for certain foods, based on Section 204 of the Food Safety Modernization Act (FSMA), as part of the New Era of Smarter Food Safety initiative.

In the comments, NACS signaled support for efforts to boost food traceability and safety in the food system. However, there are concerns that small retailers, which represent 61.4% of all convenience stores in the United States, will not be able to meet the proposed additional recordkeeping requirements. The two primary reasons are:

  1. There are serious unaddressed financial and infrastructure challenges that will prevent food retailers from being able to implement traceability systems in their stores. For the convenience industry, where most businesses are not just small businesses but are single-store operations, the financial cost of installing and maintaining a traceability system would be prohibitive. The FDA’s cost estimates do not accurately capture the actual price tag that would await small retailers. Beyond the financial cost, neither the proposed rule nor the food industry has yet to reckon with how traceability systems throughout the supply chain will be able to share the information collected with each other. Interoperability among traceability systems must be put in place before anything like the requirements being proposed could work, but currently the issue is being ignored entirely. 
  2. It would be inefficient for regulators to hold convenience stores and other food retailers responsible for maintaining traceability records. The product and traceability data on the food supplies that convenience stores sell come from their distributors or parties further upstream; the proposed implementation of traceability lot codes containing key data elements will not affect this. Convenience retailers are at the end of the supply chain, where information on the food items being passed along has already been recorded by other parties. Requiring retailers to store traceability data will not aid FDA in tracking and limiting the harm done by food contamination. Rather, the agency should focus its additional traceability requirements on distributors, who are well-positioned within the supply chain to assist.

NACS commented that convenience stores require food manufacturers to hire external auditors to assess manufacturer food safety practices, and these audits have been linked to more use of food safety testing and equipment technologies. Some larger convenience chains even contract to have their distributors and suppliers meet traceability requirements on their food products.

“Convenience stores should not be expected to manage repositories of data from critical tracking events; that role is already being played by the distribution sector of the supply chain,” NACS told FDA.

“The proposed rule will squeeze the convenience industry if executed as is, and will not bring about the results the agency seeks,” wrote NACS, adding that FDA should revamp the proposal in the following ways: 

  • First, as FDA has itself suggested in its New Era Blueprint, the agency should collaborate with industry partners to pilot traceability concepts like interoperability and public-private data sharing.
  • Second, FDA should work with an industry subcommittee to set performance standards that all traceability systems will need to meet. NACS looks forward to working with FDA to make the necessary progress on interoperability and standards—progress that has not yet happened but is a necessary precursor to FDA finalizing regulations on this topic.
Noting that convenience retailers would not be able to comply with FDA’s proposal in two years, the agency could begin to chart the course for stakeholders by collaborating with the industry by: 
  • Working with stakeholders to design and execute pilots on concepts needed for traceability to further scale, such as testing interoperability and public-private data sharing, as the FDA has previously stated. Testing approaches and technologies to implementing and enhancing industry-wide traceability first—before mandating compliance—would give all parties a clear picture of what can and should be done, and what should be avoided.
  • NACS can assist FDA by convening a working subcommittee to help set the standards that traceability systems must meet for track and trace to work in the supply chain. In this nascent moment, the FDA should clarify what duties, technologies and processes are necessary, and what can be handled later. Even the best run and most technologically advanced supply chains cannot guarantee 100% traceability. Rather, FDA should work with retailers to focus on building strong foundational components that can sustain a practical, targeted and efficient traceability ecosystem within our industry.

Although the proposed rule is part of a broader effort to establish a comprehensive, technology-based food traceability system, NACS concludes that the recordkeeping requirements the FDA seeks to implement will have harmful effects on food retailers “if not implemented slowly and targeted toward the proper actors.”

For more information about the FDA’s proposed traceability rule, contact Jon Taets, NACS director of government relations, at