— OPINION —
By Brian Ronholm, Director of Food Policy for Consumer Reports, and Frank Yiannas, Former Deputy Commissioner, Food Policy & Response, FDA
Both of us have dedicated our careers to advancing food safety and protecting the public. Collectively, we’ve done so at the height of federal service, in consumer advocacy, and within the private sector. That’s why we believe we’re well qualified to provide a perspective on the need for better traceability capabilities throughout the entire food system.
Once a foodborne outbreak is detected, one of the most important details needed is identifying the food item causing the illnesses and removing it from the marketplace to prevent additional illnesses. It’s critical to ensure that this is accomplished with speed, accuracy, and specificity.
However, recent legislative proposals would undermine the current data record keeping requirements in the Food and Drug Administration’s (FDA) FInal Food Traceability Rule. We felt inclined to write this column because if these proposed changes are enacted, it would harm the FDA’s ability to identify sources of outbreaks, and protect consumers when unsafe food enters the marketplace.
Historical context
As a reminder, Congress passed the Food Safety Modernization Act (FSMA) in a bipartisan manner and President Obama signed into law in 2011. As part of FSMA, Congress specifically directed the FDA to develop a Food Traceability Rule, referred to as Section 204, that requires producers of certain foods to enhance food traceability record keeping requirements and data sharing capabilities in the midst of an outbreak investigation. That was 13 years ago.
Shortly after FSMA was signed into law, the FDA conducted traceability pilots in partnership with industry and the Institute of Food Technology (IFT). The lessons learned from those pilots were incorporated in the current Traceability Rule.
However, after the initial pilots, the agency failed to make timely progress, which resulted in a lawsuit for failing to meet this requirement. Fortunately, the FDA fulfilled its obligation per a court-approved consent decree and issued a Final Food Traceability Rule in November of 2022, more than eleven years since the signing of FSMA, with a compliance date of January 20, 2026.
The need for better traceability has never been greater
With numerous foodborne outbreaks still taking too long to resolve, especially within the last year, it continues to be demonstrated that FSMA had it right — the need for better food traceability capabilities can’t wait.
Fortunately, we’re now seeing real progress being made and we can’t allow for this momentum to be stopped. In fact, some of the nation’s largest retailers have already started communicating to their suppliers what they expect from them to be in compliance with FDA’s Food Traceability Rule before the FDA’s compliance date.
Breakthroughs in food traceability are occurring today primarily because of the main components of FDA’s rule, including the establishment of Key Data Elements (KDEs), Critical Tracking Events (CTEs), a Food Traceability Lot Code, as well as a List of Foods (FTL) for which these additional data keeping requirements will apply. The rule also requires covered food entities to be able to provide required food traceability records to the FDA, if requested, within 24 hours.
Overall, the rule’s requirements will allow FDA and food companies to quickly identify and remove contaminated food from the market and, in turn, prevent foodborne illnesses and strengthen consumer protections.
Resisting calls for delays or changes that would make the rule ineffective
Despite this great progress, recent efforts by certain industries will undermine the rule. Pending legislative language in Congress would require the FDA to conduct additional pilot studies and delay the compliance date of the rule. Alarmingly, this language also would not require restaurants, retail food establishments, and warehouses to maintain traceability lot code information or provide traceability lot code information. If this provision were enacted, it would have the effect of undermining the traceability rule.
The requirement that Traceability Lot Codes be captured at point of service — to include retail establishments and restaurants — is critical to solving outbreaks. Without lot code information at point of service, the outbreak investigation process would have similar ineffective capabilities that currently exist that have resulted in consumers being exposed to contaminated foods for too long. The current system also results in overly broad consumer advisories that can be harmful to food producers whose products are unaffected.
Polls show our bosses, the consumer, want the rule to go into effect as written
While better food traceability will benefit all stakeholders, consumers stand to benefit the most and they do not want any more delays. A recent Harris Poll survey shows that a majority of U.S. adults — more than half of 2,088 poll respondents — are opposed to efforts that would narrow the scope and delay enforcement of the traceability rule. Only 23 percent of the respondents believe that it is too difficult for companies to comply with the rule.
As is the case with all meaningful progress, there will always be a few that will be critical and resist change. However, now is not the time to stop or slow things down. Too much progress is being made, and there has been too much momentum, and consumers deserve and expect the food system to be able to promptly trace products to its source during a foodborne crisis.
Both of us appreciate the work the FDA has done to complete the traceability rule and to educate the industry on how to comply. On behalf of consumers everywhere, we urge congressional leaders to reject efforts to eliminate the requirement that traceability lot codes be captured at retail and food service, and we certainly urge Congress to reject requests for further, substantive delays.
Simply put, there’s too much at stake and better food traceability can’t wait.
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