FDA Imposing New Rule on Traceability of High-Risk Foods


The FDA has proposed “requirements for additional traceability records for certain foods” as a component of the New Era for Smarter Food Safety, consistent with the Food Safety Modernization Act of 2010.  Foods regarded as high-risk for which records must be maintained include shell eggs and a range of vegetables and fruits implicated in foodborne outbreaks during the past five years.


In announcing the initiative, the FDA noted, “While limited to only certain foods this proposal lays the foundation for a standardized approach to traceability and record keeping paving the way for the industry to adopt, harmonize and leverage more digital traceability systems in the future”.



Frank Yiannas Driver of the FDA Traceability Initiative


The proposed rule will permit either electronic or paper records.  In the event of a disease traceback, the company concerned will have to provide an electronic spreadsheet containing relevant traceability information within 24 hours of a request by the FDA.  Key data elements include the traceability lot code, date product was received, date product was shipped and a product description presumably including packing.


The FDA will hold public meetings on November 6th and 18th and December 2nd to review public comments on the proposed requirement before publishing a Final Rule.