FDA Begins Unveiling Tougher Food Safety Rules

Preparing to assert its new authority to protect the safety of the nation’s food supply, the Food and Drug Administration (FDA) has rolled out two new regulations that will take effect this summer.

The new rules stem from greater power given the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. The legislation is designed to up-date a U.S. food safety system which was decades old in the face of repeated outbreaks of e. coli, salmonella, and other pathogens found in a variety of foods in recent years.

Foodborne pathogens cause 76 million illnesses, 325,000 hospitalizations and 5,000 deaths annually, and may contribute to long-term disease in more than 1 million Americans, according to estimates by the U.S. Centers for Disease Control and Prevention (CDC). Furthermore, the total economic impact of foodborne illness across the nation is estimated to be $152 billion annually, according to the Pew Charitable Trusts website.

The new FDA rules will take effect July 3, the agency says.

The first rule strengthens FDA’s ability to prevent potentially unsafe food from being sold. It allows the FDA to administratively detain food the agency believes has been produced under insanitary 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.

Beginning 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. The products will be 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 says it 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 says it 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,” says 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 United States to inform the FDA if any country has refused entry to the same product, including food for animals.

This new requirement will provide the agency with more information about foods that are being imported, which improves the FDA’s ability to target foods that may pose a significant risk to public health.

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, the agency says.

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 agency says.

“The new information on imports can help the FDA make better informed decisions in managing the potential risks of imported food entering the United States,” Taylor says. “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 FDA continue building the new food safety system called for by Congress.”

 Scott Nance is the editor and publisher of the news site The Washington Current. He has covered Congress and the federal government for more than a decade.


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