Sep 8, 2009 (CIDRAP News) – The US Food and Drug Administration (FDA) today launched the Reportable Food Registry, an electronic portal designed to prevent foodborne illness outbreaks in real-time by speeding the response at the first sign of a positive test for a pathogen or contaminant in food or animal feed.
Facilities that make, process, or hold food must now notify the FDA within 24 hours if they find, through their own or third-party testing, that a food might sicken or kill a human or an animal. Companies aren't required to submit the report if they found the problem before the food or feed was shipped and corrected it or destroyed the food.
The reporting requirement applies to all foods and animal feed that the FDA regulates except for dietary supplements and infant formula, which have their own regulatory requirements, the FDA said today in a press release. Federal, state, and local officials can also file reports through the electronic portal.
At a press conference today to announce the launch of the new portal, Michael R, Taylor, senior advisor to FDA Commissioner of Food and Drugs Margaret A. Hamburg, MD, said, "This begins moving us further down the road to preventing food safety problems."
Hamburg said today in the press release that President Obama has pledged to strengthen food safety. "The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge."
"By fostering real-time submission, this system will enhance the FDA's ability to act more quickly," Taylor said. Though many companies already notify the FDA as soon as they detect a problem, the Reportable Food Registry creates a legally enforceable duty for companies to file the reports.
The new rules also permit the FDA to require companies to notify their sources and firms that received the products. "This gives us information we many not have had before," Taylor said.
The new rules require companies to investigate the cause of adulteration if it may have originated with them, submit additional information and supplemental reports, and work with the FDA to follow up as needed.
Congress established the Reportable Food Registry in 2007, Taylor said. In a December 2008 progress report, the FDA noted that it had awarded a contract to create the electronic portal.
The FDA held three public workshops with stakeholders to seek industry feedback. In late August, three associations that represent companies that process feed ingredients and pet food sent a letter to the FDA asking the agency to postpone today's start date for reporting by 45 to 60 days and to allow a phase-in period.
Taylor said the FDA also issued guidance today for companies on using the portal. He said the FDA would continue to listen to stakeholders in order to fine-tune the guidance.
Craig Hedberg, PhD, a foodborne disease expert at the University of Minnesota in Minneapolis, told CIDRAP News that although he endorses the concept of reporting problems to the FDA early, he's not certain an electronic portal is the best vehicle for the communication.
A better option might be a system in which FDA experts who are familiar with the company operations can be called when problems arise.
"If this is supposed to be a fast track to public health intervention, then people who can help manage the intervention should be involved in the assessment from the beginning," he said. "There are many situations that require human interaction, both to facilitate a prompt and appropriate response, and to ensure that everyone has a common understanding of the problem."
"I'd rather see us invest in changing the system than to invest in an Internet system that may not be an actual solution," Hedberg said.
See also:
Sep 8 FDA press release
FDA Reportable Food Registry Web site
http://www.fda.gov/Food/ComplianceEnforcement/RFR/UCM2019388.htm
Letter from feed and pet food industry groups to the FDA
