Regulation and enforcement are keystones to new FDA import policy

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“Companies that sell contaminated products need to face serious penalties,” says FDA chief.By Peter A. Buxbaum, AJOTFood and drug manufacturers, shippers, and importers will be required to shoulder greater responsibility for the safety of their imported products and face stiffer penalties if they do not, under legislation currently pending in Congress and a new regulatory regime to be proposed by the Food and Drug Administration.
The FDA is also in the process of deploying a new border screening initiative designed to prevent contaminated food and medicines from entering the United States.
The new FDA initiative was revealed by FDA commissioner Margaret Hamburg in a recent speech before a gathering sponsored by the Center for Strategic and International Studies in Washington. “It is simply not possible for FDA to inspect our way to safety,” she said.
In the aftermath of 9/11, it was the threat of terrorism which most worried government agencies responsible for securing imports. These days the concern over tainted products, particularly from China, have taken center stage. These were the concerns cited by Hamburg in support of the FDA initiative.
In 2007, melamine-contaminated ingredients manufactured in China made their way into U.S. pet foods and animal feed, causing illness and death among pets. This incident caused the recall of hundreds of brands of pet food and quarantines on livestock that had consumed suspect feed.
Soon after the melamine incident, the poisonous industrial chemical diethylene glycol, or DEG, was found in toothpastes imported from China. FDA import alerts led to a voluntary recall of the contaminated products but in other countries, the contamination led to scores of deaths. In another incident, a contaminated blood thinning drug from China caused deaths and allergic reactions in the U.S.
The post-9/11 environment spawned government programs such as the Customs-Trade Partnership Against Terrorism (C-TPAT), a voluntary program in which manufacturers, shippers, and logistics providers adopted certain standards in exchange for more favorable customs treatment. The FDA initiative, by contrast, appears to involve, less of a voluntary carrot and stick approach, and more of a program that includes legislation, regulation, and enforcement.
The globalization of the world economy has meant that the United States imports more and more of the food and drugs it consumes and has led the FDA to play a bigger role in regulating and inspecting imports. FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities, Hamburg noted.
“Globalization has multiplied the scale of our responsibility, and the challenges we face,” she said. “This year, we expect that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.”
Around 15 percent to 20 percent of all food and 40 percent of all drugs now consumed in the U.S. are imported and 80 percent of the active pharmaceutical ingredients in imported drugs come from foreign sources, according to Hamburg. “Some 70 percent of seafood and about 35 percent of fresh produce consumed in the U.S., come from outside our borders,” she said. “Strikingly those are some of the most vulnerable foodstuffs in terms of potential for contamination.”
The result has been that FDA inspectors have become overwhelmed. “The estimated 20 million shipments of FDA-regulated imports that will come into the country this year will be handled by fewer than 500 inspectors,” said Hamburg. “Though these employees work tirelessly, they typically are able to examine less than one percent of these products before entry into the U.S. But it is simply not possible to count on interdicting everything harmful at our borders.”
The FDA has gone to some lengths to establish inspection programs at fore

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Peter Buxbaum has been writing about international trade and transportation, as well as security, defense, technology, and foreign policy, for over 20 years. Besides contributing to the AJOT, Buxbaum's work has appeared in such leading publications as [em]Fortune, Forbes, Chief Executive, Computerworld, and Jane's Defence Weekly[/em]. He was educated at Columbia University.