Today marks the end of the enforcement discretion period for U.S. Food and Drug Administration’s (FDA’s) new program for keeping contaminated food out of the food supply.
In September, the FDA launched the Reportable Food Registry (RFR), an online portal for those in the food industry to report food contamination if there is “a reasonable probability that an article of food will cause serious adverse health consequences.”
The RFR went live on September 8, 2009 but in its guidance for industry the agency indicated it would “exercise enforcement discretion” for a 90 day period, until December 8, 2009.
It remains largely unclear whether there will be an increase in enforcement action from RFR reports. Inquiries about the status of the program, the number of reports, and the swiftness of agency enforcement action were not immediately returned. In September, an FDA spokesperson told Food Safety News that the agency has received “some” reports from food facilities, but declined to specify how many.
The legal authority for FDA’s RFR was created by the Food and Drug Administration Amendments Act of 2007 (FDAAA). The law requires any “responsible party”–which includes any registered food facility that manufactures, processes, packs, or holds food for human or animal consumption–to issue a report to the online portal within 24 hours if they become aware of food that could likely cause serious consequences to the people or animals.
The only two foods explicitly exempt from the RFR’s definition of “reportable food” are infant formula and dietary supplements. The mandated system applies to pet food and animal feed as well as international food facilities.
Once reports are submitted, the FDA will follow up with the food facilities and evaluate the appropriate course of action.
While consumer and food safety advocates commended the agency’s effort to improve food safety, most agreed it would take some time to determine whether the system would have a significant impact.