F.D.A. issues two new food safety rules

by Keith Nunes
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WASHINGTON — The Food and Drug Administration issued two new food safety rules Wednesday afternoon. The first rule involves the agency’s authority to order the detention of adulterated or misbranded products, and the second rule requires companies exporting products to the United States to notify the F.D.A. if any other country has refused entry of the products. Both rules are scheduled to take effect July 3, 2011.

The F.D.A. said the detention authority strengthens the agency’s ability to prevent potentially unsafe food from entering commerce. It allows the F.D.A. to administratively detain food the agency reasonably believes has been produced under insanitary or unsafe conditions. Previously, the F.D.A.’s ability to detain food products applied only when the agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.

The Federal Register notice said decisions regarding “the F.D.A.’s ‘reason to believe’ a food is adulterated or misbranded would be made on a case by case basis because such decisions are fact specific.”

“This authority strengthens significantly the F.D.A.’s ability to keep potentially harmful food from reaching U.S. consumers,” said Mike Taylor, F.D.A. deputy commissioner for foods. “It is a prime example of how the new food safety law allows F.D.A. to build prevention into our food safety system.”

The F.D.A. said the import requirement will provide it with more information about foods that are being imported, which improves the agency’s ability to target foods that may pose a significant risk to public health.

The new reporting requirement will be administered through the F.D.A.'s prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

“The new information on imports can help the F.D.A. make better informed decisions in managing the potential risks of imported food entering the United States,” Mr. Taylor said. “These rules will be followed later this year and next year by a series of proposed rules for both domestic and imported food that will help the F.D.A. continue building the new food safety system called for by Congress.”

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