The U.S. Food and Drug Administration has proposed new traceability rules as part of its implementation of the 2011 Food Safety Modernization Act.
The rules add record-keeping requirements for those who process and pack foods, though it includes an exemption for fishing-vessel owners that are not directly affiliated with a processing facility. Additionally, while the law already included a provision placing all finfish (including smoked fish) and mollusks (bivalves) in the FDA’s draft Food Traceability List, identifying them as among the foods with the highest risk of contamination and subject to additional record-keeping mandates, the new proposed rule allows for changes to the list in the future.
The proposed rules lay the foundation for the end-to-end food traceability across the food industry which would “better establish linkages throughout the supply chain during a foodborne illness outbreak investigation and more quickly identify potential sources of contamination and prevent additional illness and death,” FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said in a press release.
The changes will help the FDA avoid “blanket alerts” on whole commodity sectors, Yiannas said.
“For instance, in some past leafy green outbreaks, the FDA has had to call for all romaine lettuce to be removed from the marketplace when the available supply chain information could not pinpoint a specific entity that produced the lettuce linked to the illnesses,” he said. “With this proposed rule, we’re hoping to avoid situations like this in the future.”
The National Fisheries Institute, the largest seafood trade group in the U.S., said it is still reviewing the proposed rule and requirements being imposed on the industry as a result of seafood’s placement on the food traceability list. In a statement, NFI President John Connelly said his organization supports efforts to modernize and advance food safety, but is concerned the implementation of the list could create a confusing or duplicative regulatory environment.
“As with any new regulatory structure, we are interested in ensuring there are no duplicative systems that would complicate the new traceability parameters,” Connelly said. “An initial review of the draft food traceability list from a seafood perspective, suggests a ‘one-size-fits-all’ approach, which may not be warranted. Just like with HACCP and other modern food safety efforts, a focus on a few critical points or products is a better use of energy and resources.”
Connelly said the NFI hoped the introduction of the new rules “will help begin an orderly process that integrates modern supply chain traceability systems within a technologically advanced regulatory structure.”
The FDA is soliciting comments on the draft of its proposed changes over the next four months and is in the process of scheduling public hearings. The changes, if adopted, would be published in the Federal Register and become effective 60 days from the publication date, with mandatory enforcement of compliance with the new rules coming into effect two years from the date of publication.
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