USDA issues new rules effective in July

May 9, 2011

The USDA announced two new regulations, the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January, to help ensure the safety and security of foods in the U.S. Both rules will take effect July 3, 2011.

The USDA announced two new regulations, the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January, to help ensure the safety and security of foods in the U.S. Both rules will take effect July 3, 2011.

Strengthening FDA's ability to prevent potentially unsafe food from entering commerce, the first rule allows the FDA to administratively detain food the agency believes has been produced under unsanitary or unsafe conditions.

Previously, the FDA'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.  In July, the FDA will be able to detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace, while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product in commerce is necessary. Before this new rule, the FDA would often work with state agencies to embargo a food product under the state's legal authority until federal enforcement action could be initiated in federal court.  In keeping with other provisions in the FSMA, FDA will continue to work with state agencies on food safety and build stronger ties with those agencies.

"This authority strengthens significantly the FDA's ability to keep potentially harmful food from reaching U.S. consumers," said FDA Deputy Commissioner for Foods Mike Taylor.  "It is a prime example of how the new food safety law allows FDA to build prevention into our food safety system."

The second rule requires anyone importing food into the U.S. to inform the FDA if any country has refused entry to the same product, including food for animals. This new reporting requirement will be administered through the FDA's prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. With prior notice, in the event of a credible threat for a specific product or a specific manufacturer or processor, the FDA is able to mobilize and assist in the detention and removal of products that may pose a serious health threat to humans or animals.

The issuance of these rules is the latest accomplishment of FDA in implementing the new food safety law.  In April, the FDA launched a consumer-friendly web search engine for recall information and issued the first annual report to Congress describing FDA's activities in protecting the U.S. food supply. FDA also released a guidance document to the seafood industry on ways to reduce or eliminate food safety hazards.

FDA Web Page:  Food Safety Modernization Act (http://www.fda.gov/Food/FoodSafety/FSMA/default.htm)

Federal Register Notice for Interim Final Rule on Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption http://www.ofr.gov/OFRUpload/OFRData/2011-10953_PI.pdf

Federal Register Notice for Interim Final Rule on Information Required in Prior Notice of Imported Food http://www.ofr.gov/OFRUpload/OFRData/2011-10955_PI.pdf

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