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FDA imposes new 24-hour rule for food safety threats

All food companies are now required to report any potential dangerous products within 24 hours to the U.S. Food and Drug Administration under a new food registry announced this week.

Reporting is required through the Reportable Food Registry (RFR), an electronic mechanism for food companies to file reports when there is a “reasonable probability that an article of food will cause serious adverse health consequences,” FDA officials announced Tuesday. This includes all foods regulated by the FDA, with the exception of infant formula and dietary supplements because they are covered by other regulatory requirements.

“By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA's ability to act quickly to prevent foodborne illness,” Michael Taylor, senior advisor to the FDA commissioner, said in a prepared statement. "Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers' hands.”

But the Grocery Manufacturers Association raised concerns. Robert Brackett, GMA chief science officer, said it is unclear if a parent firm that uses a manufacturer or co-packer would also be required to report if a problem was found at the manufacturer, or through a customer. He also questions whether firms must report a “presumptive positive,” or wait until there is confirmation, and if a reportable product is sent to a non-registered facility, would the non-registered facility need to report?

“GMA welcomes the launch of the FDA's Reportable Food Registry,” said Brackett. “However, the guidance document provided by FDA raises a number of questions and ambiguities that need to be quickly clarified by FDA, and while the registry will serve an important purpose, we continue to believe that the key to strengthening our food safety system is through the continuous strengthening of food safety practices that that will prevent foodborne incidents before they occur."

FDA officials said all companies must file a report within 24 hours of becoming aware of any food product that poses a threat. The new requirement gives only registered food facilities that manufacture, process, pack, or hold food for human or animal consumption the ability to report anything suspicious. After a report has been submitted, companies must cooperate with the FDA to determine the origin of the contamination and be prepared to conduct an investigation if the problem originated within the company. Businesses also must notify suppliers and distributors if the questionable product has been shipped.
Some of the issues companies should be alerted to include the following:

• Any bacterial contamination.
• Allergen mislabeling.
• The presence of high levels of certain chemicals.

Federal, state, and local government officials may voluntarily use the Reportable Food Registry as well. Details of the FDA guidelines for reporting are available at fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm.
In emergencies, consumers, food retailers and food service operators should continue to call FDA at 301-443-1240. For less urgent problems, contact the FDA consumer complaint coordinator in your area, or see Your Guide to Reporting Problems to the FDA at fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm.

In a related announcement on Wednesday, the U.S. Department of Health and Human Services announced a new website for consumers seeking information on food safety. By visiting www.foodsafety.gov, consumers can have access to all federal agencies in one place. The website also contains information on recalls and contaminations alerts.

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