FDA Implementing Food Safety Modernization Act

The first two rules established by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA), signed into law in January, will take effect July 3.

The first rule permits the FDA to administratively detain, for up to 30 days, food products that the agency believes have been produced under unsanitary or unsafe conditions. Previously, the agency could do so only when it had credible evidence of contamination or mislabeling that presented a threat of serious adverse health consequences or death to humans or animals.

In the past, the FDA would collaborate with state agencies to use the state’s legal authority to hold a food product until federal courts could give the go-ahead for enforcement action. The agency said that those partnerships would continue.

The second rule mandates that any food importer must inform the FDA if any other country has refused entry to the same product. The agency says that the new reporting requirement will provide it with more information about imported foods and enhance its ability to pinpoint significant public health risks.

How common is “port shopping”? “That’s a very good question,” said Jeff Bender, DVM, MS, director of the Center for Animal Health and Food Safety (CAHFS) at the University of Minnesota in St. Paul. “Very little of the food coming in through our ports is inspected. Estimates are that it’s about 1%. With the current system, we know what the shipper says is in the shipment, and then with a high-risk product, they might open up the crate to say, ‘Yes, these are oysters, and here’s how they were packaged.’”

Setting up a system to implement the requirement, which will be done through the FDA’s prior notice system for incoming shipments of imported food, will be a significant improvement over the current state of affairs, Bender said. “Right now, a lot of the information is paper trailed, and that is incredibly laborious. Improving the logistics and informatics about products moving between ports will be a huge step above current regulations,” he says.

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