Can the FDA Police the World?
By Steven Gray
On Sept. 16, 2010, a team of U.S. Food and Drug Administration investigators arrived at a Shanghai purveyor of dough, macaroni and baby cereal. Federal authorities had long suspected that Sanghai Chuangi Food Co.'s plants were unsanitary. Many of its products, like soup base, had been shipped to the port of New York and ultimately placed in an unknown number of goods that ended up on kitchen tables in the U.S. That's why federal authorities assigned to one of the FDA's new Chinese offices warned that country's government of their plans to pounce. FDA inspectors and a Chinese translator went to several Shanghai addresses listed for the company. Each time, representatives who answered the door refused to make executives available or allow inspectors inside. They even said the company didn't ship to the U.S. — which, of course, was a lie. Within a month, the FDA issued an import alert, banning Shanghai Chuangi's products from the U.S.
If you find that story reassuring, don't. The U.S. receives scores of tips about unsafe imported food each year, but the FDA inspects only about 1% of the roughly 10 million products shipped into the country annually. Blame it partly on a lack of funding and, until recently, authority.
In January, however, things changed. President Obama signed the Food Safety Modernization Act, potentially the most sweeping overhaul of the nation's food-safety system in nearly three-quarters of a century. The law directs the FDA, regulator of about 80% of food consumed in the U.S., to prevent outbreaks of food-borne illnesses like salmonella. That's no small matter: nearly 1 in 6 Americans — 48 million people — contracts a food-borne illness each year; 3,000 die as a result. Much of the new law will deal with domestically grown food, which accounts for about 85% of what Americans eat. But one of the most intriguing effects of the law will be the launch of a massive effort to inspect the increasing amount of imported goods: in the coming years, the FDA is expected to spend nearly $1.4 billion to hire hundreds of staffers and private contractors to inspect the expanding number of foreign food suppliers.
The question is, Can the FDA police the world? It was only a century ago that Upton Sinclair wrote The Jungle, a groundbreaking book that described, in horrific detail, how spoiled meat was doused with soda to remove the scent of rot before it was hauled off to free-lunch counters. The book led to the enactment of the Pure Food and Drug Act and the formation of the FDA.
Today, of course, the FDA is a massive agency: it regulates more than $466 billion worth of food and about 25¢ of every consumer dollar spent. Yet its imported-food mandate will be difficult to execute, mainly because globalization has sharply broadened the American palate. At ordinary supermarkets in Chicago, Charlotte, N.C., or Boise, Idaho, ingredients like chipotle sauce, couscous and coconut milk are no longer marginalized to the imported-food aisle — if such a section exists. About 60% of the U.S.'s fresh fruits and vegetables are imported, as is about 80% of seafood, much of it from countries with questionable food-safety regulations. "Globalization has presented its own food-safety challenges, which must be addressed," the FDA's deputy commissioner for foods, Michael Taylor, told a Shanghai audience recently.
The truth is, the FDA has struggled to keep up with the globalized food business. The evidence regularly appears on the evening television news: In 2008, the FDA warned that melamine, a compound frequently used to make plastics, had been found in Chinese infant formula, leading the agency to ban such products. In another case that year, clusters of illnesses in the U.S. prompted the FDA to investigate how jalapeño and serrano peppers imported from Mexico had become infected with salmonella. Ultimately, the agency warned consumers to avoid the peppers. Partly in response to such cases, the FDA has opened offices in far-flung cities like Guangzhou, Mumbai and Mexico City and has even dispatched a team of seafood experts to train Bangladeshi officials about U.S. food-safety standards.
The new law will take those efforts to a higher level. For starters, the FDA will hire hundreds of staffers to inspect thousands of overseas food facilities in the coming years. In Shanghai recently, Taylor said, "It is clear that the FDA can't be everywhere all the time, especially when it comes to the oversight of imported foods." So the agency will hire third-party certifiers. The handful of firms that inspect and certify food are preparing for an uptick in business. One of those firms is Bureau Veritas, a French concern. The company is already familiar with the U.S. regulatory process. Its office across from Walmart's Bentonville, Ark., headquarters advises the retail giant on how its products can meet U.S. safety standards. The company has conducted certification tests with the FDA on Vietnamese shrimp. Patrick Bele, Veritas' food-business-development manager, says of the new safety law: "It's going to be an opportunity to hire more people, invest in more labs. It will give us an extra push in growth."
Two potential barriers to the law's implementation are politics and money. Congressional Republicans have suggested that the FDA's budget be trimmed by $220 million. "Certainly, food safety is a high priority," says Congressman Jack Kingston, Republican of Georgia, who argues that the relative rarity of food-borne illness means the current system is effective. "But money is scarce," he says.
It may seem easy to dismiss such rhetoric since the Senate, which remains dominated by Democrats, is unlikely to erode a signature legislative victory backed by the Obama Administration and Big Food. But the law's advocates fear that the drive to cut the FDA's budget could gain traction in the next two to four years if Republicans take control of both chambers of Congress. "It's good to say the food supply is safe, but it has to turn out that way," warns Caroline Smith DeWaal, food-safety director at the Center for Science in the Public Interest, a Washington advocacy group. She adds, "There are risks to their own constituents if they're exposed to contaminated foods ... The Republicans will be left holding the bag."
Meanwhile, back in China, Shanghai Chuangi hasn't taken key steps toward redemption, like testing questionable plants. FDA inspectors have yet to return to the company's facilities either. Without adequate funding, it's worth wondering if they ever will.
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