The FDA has announced what it calls movement on implementation of the Food Traceability Rule, but some food safety experts say the agency isn’t really moving the needle.
In its announcement, the Food and Drug Administration said it is scheduling a series of “engagements” with stakeholders to ensure that industry has the information and tools to comply with the Food Traceability Rule.
The Rule was mandated by the Food Safety Modernization Act of 2011. There have been years of pubic hearings, consultations with industry, drafts of the Rule and reactions to it. The Rule, put simply, requires businesses to maintain records that allow for the tracing of the movement of food in the United States. It was conceived of to help with the investigation of foodborne illness outbreaks.
Industry, from farmers to retailers, has balked at the Rule, saying it puts undue burdens on them. Those businesses often keep only paper records of only some transactions and frequently cannot find information when the FDA asks for it during outbreaks and recalls.
“The final rule requires such entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help FDA rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death,” according to the FDA.
Even though the FDA has been working on the Rule since 2011, seeking industry input all along the way, it plans more talks with stakeholders.
At least two food safety leaders are saying enough is enough.
Sandra Eskin, CEO of STOP Foodborne Illness and former USDA deputy under secretary for food safety, told Food Safety News it is good that the FDA made sure that companies have what they need, but says that work is complete.
“The decision to delay it was unfortunate but if retailers and small entities subject to the rule were challenged to comply with it, hopefully FDA can address these challenges in the extra time to comply with the guidance and the stakeholder engagement. I sure hope that FDA does not reopen the regulation,” Eskin said.
Frank Yiannas, former FDA deputy commissioner for food policy and response, went further. He told Food Safety News that the FDA’s announcement did not describe true actions.
“More listening sessions might sound nice, but we’ve already conducted numerous pilots, held public meetings, and a multitude of stakeholder listening sessions. It’s been 15 years since Congress asked FDA to implement a food traceability rule. At some point, we need less talk, less endless meetings, and more action,” Yiannas said.
“Solving foodborne illnesses, many that go unresolved, strengthening root cause investigations, and preventing recurring outbreaks depends on it. It’s time to move on.”

