WASHINGTON — We all know that the last of the Food and Drug Administration’s Food Safety Modernization Act (FSMA) 11 rules, the Food Traceability Rule, was issued Nov. 15, 2022, designed to facilitate faster identification and rapid removal of potentially contaminated food for the marketplace, resulting in fewer foodborne illnesses and or deaths. The list of foods captured in that rule included a broad variety of foods from fresh cut fruits and vegetables, shell eggs, and nut butters to certain fresh fruits, vegetables, ready-to-eat deli salads, cheeses and seafood products.  It sounds straight forward but actually the devil is in the details for the tens of thousands of food products captured by the sweeping rule when it comes to broad food industry implementation.

To date, the FDA has not been able to establish a comprehensive list of products it expects to be traced. In truth, this costly rule is completely reactive rather than appropriately focused on proactive, preventative food safety measures, which is where the food industry has been focusing its efforts and activities.    

Let’s face facts: the Food Traceability Rule goes well beyond the scope and dimensions Congress intended when it passed FSMA over 12 years ago. The intent was to focus only on “high risk” foods. In reality, this rule will lay the burden of an unworkable product tracing requirement where there is no current technology available to accomplish this herculean task. The rule in its current form creates an enormous amount of recordkeeping that industry will have to maintain for a whopping two years, much longer than the perishable product life cycle. Plus, the FDA cannot effectively use these records in a timely manner because the agency does not have the infrastructure and staff resources to support this daunting task.

The good news is that there is legislation that aims to resolve the most problematic provisions and requirements of the Traceability Rule. The Food Traceability Enhancement Act, H.R. 7563, is a bi-partisan bill aiming to require practical changes and make additions to address compliance challenges within the Food Traceability Rule. There are six key elements of the legislation that would enable industry to overcome compliance challenges as this significant rule is put into practice.   

First, the requirement that restaurants, retail food establishments, and warehouses that primarily distribute to these establishments maintain traceability lot codes would be removed. Next, the FDA would be required to conduct pilot projects in coordination with the food industry to measure the effectiveness of conducting outbreak investigations without the use of traceability lot code information and identify and evaluate the feasibility and effectiveness of low-cost food tracing technologies. Further, the FDA would be required to provide a report to Congress within 18 months of the bill’s enactment on the findings of the pilots’ outcomes, including recommendations to minimize disruptions across the food supply chain; ensure product availability and diversity are not impacted, and reduce compliance burdens for small businesses; identify low-cost food tracing technologies commercially available; and a list of all the revisions to the rule necessary as a result of the pilots.

Also importantly, the compliance date for the rule would be extended at least two years following the completion of the pilot projects.

Lastly, within 90 days of the enactment of the bill, the FDA would be required to provide a report to Congress outlining any legal and other barriers that prevent sharing information on foodborne illness outbreak investigations with the food industry.

These practical, legislative changes respond to the concerns of key food industry stakeholders and would streamline traceability activities, rein in costs for the agency and industry, and enable traceability to be achieved for a stronger food safety system. I encourage companies to study the valuable solutions in H.R. 7563, consider support and to take action by reaching out to your members of Congress urging support for this proactive approach to traceability.