– Opinion –
Brian Ronholm, Food Policy Director at Consumer Reports, and Frank Yiannas, former Deputy Commissioner for Food Policy and Affairs at the FDA
We have both dedicated our careers to improving food safety and protecting the public. We have done so together at the height of federal government service, in consumer advocacy and in the private sector. That’s why we believe we are well placed to offer perspective on the need for better traceability capabilities throughout our food system.
When a foodborne illness outbreak is detected, one of the most important tasks is to identify the food that caused the illness and remove it from the market to prevent further outbreaks. It is important to do this quickly, accurately and specifically.
However, recent bills could undermine current data recordkeeping requirements in the U.S. Food and Drug Administration’s (FDA) Final Food Tracking Rule. We were inspired to write this column because these proposed changes, if enacted, would undermine the FDA’s ability to identify sources of infection and protect consumers when unsafe foods reach the marketplace.
Historical background
As you know, Congress passed the bipartisan Food Safety Modernization Act (FSMA) and President Obama signed it into law in 2011. As part of FSMA, Congress specifically directed the FDA to develop a food tracing rule called Section 204, which requires producers of certain foods to increase their food tracing record-keeping requirements and data-sharing capabilities during outbreak investigations. That was 13 years ago.
Shortly after FSMA was signed into law, FDA worked with industry and the Institute of Food Technology (IFT) to conduct traceability pilots. Lessons learned from these pilots are incorporated into the current traceability regulations.
However, after the initial pilot, the FDA failed to make timely progress, leading to lawsuits for failing to meet this requirement. Fortunately, the FDA fulfilled its obligations under the court-approved consent decree and issued the Final Food Tracking Rule in November 2022, more than 11 years after FSMA was signed, with a compliance deadline of January 20, 2026.
The need for improved traceability has never been greater
FSMA continues to be a vindication, especially with the numerous foodborne illness outbreaks that have taken so long to resolve in the last year. Improved food tracing capabilities are not on hold.
The good news is that we are now beginning to see real progress, and the momentum is unstoppable. In fact, some of the nation’s largest retailers have already begun communicating their expectations for compliance with FDA’s food tracing rules to their suppliers ahead of the FDA compliance deadline.
The breakthrough in food traceability has now occurred primarily through the establishment of key components of the FDA’s rule: Key Data Elements (KDEs), Critical Tracking Events (CTEs), food traceability lot codes, and the Food Product List (FTL) to which these additional data retention requirements apply. The rule also requires covered food entities to be able to provide required food traceability records to the FDA within 24 hours, if requested.
Overall, the rule’s requirements will enable FDA and food companies to quickly identify and remove contaminated foods from the marketplace, thus preventing foodborne illnesses and providing greater consumer protection.
Resist calls for delays or changes that would invalidate the rules
Despite this great progress, recent efforts by certain industries would undermine the rule. A bill pending in Congress would require the FDA to conduct additional pilot studies and delay the compliance date for this rule. Surprisingly, the bill does not require restaurants, retail food establishments, or warehouses to maintain or provide traceability lot code information. If enacted, this provision would undermine the traceability rule.
The requirement to capture traceable lot codes at the point of service (including retail stores and restaurants) is essential to resolving outbreaks. Without lot code information at the point of service, the outbreak investigation process will function as inefficiently as it currently does, resulting in extended exposure of consumers to contaminated foods. Under the current system, consumer advisories will be overly broad, potentially adversely affecting food manufacturers who produce unaffected products.
Polls show that our bosses, the consumers, want the rules to be enforced as written.
Improved food traceability benefits all stakeholders, but the biggest beneficiaries are consumers, who don’t want any more delays. A recent Harris Poll survey found that a majority of U.S. adults (more than half of the 2,088 respondents) oppose efforts to narrow the scope of traceability rules and delay their implementation. Only 23% of respondents believe it will be too difficult for businesses to comply with the rules.
As with any meaningful progress, there will always be critics and resist change. But now is not the time to stop or slow things down. Too much progress has been made, and the momentum is too strong. Consumers rightly expect the food system to be able to quickly trace products back to their origins in the event of a foodborne crisis.
We both appreciate the work FDA has done to finalize the traceability rule and educate industry on how to comply. On behalf of consumers around the world, we urge congressional leaders to reject efforts to repeal requirements for traceability lot codes at retail and foodservice, and we urge Congress to reject requests for further substantial delays.
Simply put, the risks are too great to wait for improved food traceability.
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