FDA proposes heightened traceability rules for certain produce

The Food and Drug Administration has proposed new traceability rules that seek elevated record-keeping for many fresh produce items, from all fresh-cut products to leafy greens and tomatoes.

Frank Yiannas, FDA deputy commissioner for food policy and response, said the plan is a catalyst for change for greater traceability and transparency.

The rule is a key component of the FDA’s New Era of Smarter Food Safety and implements the long-awaited Section 204 of Food Safety Modernization Act.

The FDA will still allow paper records, but all companies in the supply chain should be able to submit an electronic spreadsheet containing traceability information within 24 hours.

“More generally, the FDA encourages all food businesses to maintain their traceability records electroni-cally whenever possible, to expedite the identification of traceability information when needed to address threats to public health,” according to an FDA news release.

Yiannas acknowledged that many in the produce industry have adopted voluntary traceability standards, such as the Produce Traceability Initiative.

The current one-step forward, one step back requirement, is lacking, according to the FDA. “These requirements form a baseline for traceability recordkeeping, but they provide limited information to effectively and rapidly link shipments of food through each point in the supply chain,” according to the FDA release.

“This – and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry – can make it difficult to trace a product to its original source when necessary.” “In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations,” according to the release.

According to a statement from the California LGMA, it and its sister organization in Arizona appear to be in compliance with the proposed FDA rules.

“This has been part of the LGMA requirements since the organization was formed in 2007. Yiannas said his experience – 10 years as vice president of food safety at Walmart and almost two years at the FDA – has taught him that in some cases, companies that believe they have a compliant traceability system”doesn’t jibe with what’s really happening on the ground.

“He said that produce industry groups involved in the Leafy Greens Traceability Pilot, which is trying a similar traceback, is finding that to be true.

“They’re experiencing some of the same challenges we have,” said Yiannas, referring to FDA investigations tracking the source of romaine lettuce tainted by E. coli.

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