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Why Isn't the FDA Stopping the Epidemic of Foodborne Illness?

The agency charged with overseeing the safety of our food is out to lunch. Here's why.

| Wed Dec. 5, 2012 6:03 AM EST

In fact, during the past 20 years, the FDA has only once succeeded in pursuing a significant criminal case, according to Marler. In 1998, Odwalla, a fruit juice bottler based in California, pleaded guilty to misdemeanor charges concerning 16 shipments and agreed to pay fines totaling $1.5 million. Hardly an onerous penalty, given that the company's E. coli–tainted apple juice killed a Colorado toddler. Three years later, Odwalla's owners sold out to Coca-Cola for $181 million.

It's one thing for a cash-strapped, chronically understaffed bureaucracy to overlook unsanitary conditions at far-flung food-processing facilities. It's entirely another to ignore the scientific findings of one of its own researchers. Renee Dufault was a US Public Health Service officer who had worked happily for nine years at the FDA. Her career began to unravel, however, when she tested samples of high-fructose corn syrup for mercury contamination. It was a reasonable precaution. Caustic soda is used to manufacture HFCS, and some chemical companies use mercury to produce caustic soda. It stood to reason that the syrup could contain residues of mercury, a neurotoxin especially potent in fetuses and young children. Sure enough, Dufault’s results revealed that more than half the samples she had tested contained mercury. These preliminary studies were not extensive enough to determine whether the mercury was present at dangerous levels, but Dufault felt that the presence of any mercury was worrisome and warranted further investigation.

Dutiful bureaucrat that she was, Dufault followed FDA protocol and in 2005 brought her findings to the attention of the agency’s Center for Food Safety and Applied Nutrition. The center’s reaction caught her off guard. "I was told to stop investigating," she said in an interview from Hawaii, where she is now the executive director of the Food Ingredient and Health Research Institute.

The Center for Food Safety said it would follow up, but failed to do so. Putting public safety ahead of her career, Dufault, now 54, decided to publish her work, even though she realized that doing so would mean taking early retirement with a greatly reduced pension. Her paper appeared in the journal Environmental Health in early 2009. The FDA has yet to take any action on the mercury problem. When asked to explain why the agency has balked, a spokeswoman declined to comment.

But Dufault thinks she understands the reason. "Corporations can have too much to say about how the FDA operates," she said. "If an industry group has enough clout, the FDA is going to be deferential—and when I was investigating mercury in high-fructose corn syrup, those people did have clout. From a political standpoint, sometimes no action is the safest action—unless there are enough deaths to warrant it."

The loophole of all loopholes is that food corporations are allowed to determine on their own whether a substance should be labeled "generally recognized as safe."

The agency has further reason to take a see-no-evil attitude toward high-fructose corn syrup. The compound falls into a category called "generally recognized as safe," or GRAS. When it was established more than a half-century ago, the designation provided a reasonable solution to a potential regulatory nightmare. It was a way for food manufacturers to introduce new products containing ingredients that were universally considered safe, such as salt, sugar, pepper, caffeine, and potato starch. But thousands of less familiar chemicals have entered our diet under the GRAS umbrella. Some, such as the artificial sweetener cyclamate, have been found to have potential health risks and taken off the market.

The loophole of all loopholes is that food corporations are allowed to determine on their own whether a substance belongs on the list, without seeking approval from or even informing the FDA, as long as they act on the authority of an expert—including one on their own payroll. According to the Pew Health Group, some 10,000 compounds are approved for use in foods, and 3,000 of them have been declared as GRAS by the food industry. The agency doesn’t even know what those compounds are, and the industry does not have to reveal that information.

The Government Accountability Office condemned GRAS in a 2010 report. "Once a GRAS substance has entered the marketplace," the report said, "FDA would find it difficult to identify that substance as the potential source of a food safety problem, especially if FDA is unaware that the substance has been determined to be GRAS." It concluded that it would be "difficult, if not impossible" to trace a specific food safety problem to a specific ingredient. If the agency cracks down too hard and issues too many rejections, companies might not bother to notify the government at all, leaving it—and the public it is supposed to protect—in the dark.

The FDA's responsibilities also include inspecting seafood sold in the United States. Eighty-four percent of that seafood is now imported, and half of the imports are from Asia. Fish farmers there are able to produce tremendous volumes of shrimp, catfish, and tilapia in grossly polluted and overcrowded ponds, thanks to antibiotics and fungicides banned in the United States because they can cause antibiotic resistance or spark allergic reactions when consumed by humans, or because they are carcinogens. The agency is supposed to keep drug-tainted fish out of our food supply. But according to the GAO, it is failing miserably, or hardly even trying. In 2009 the FDA tested only 1 out of every 1,000 imported seafood products—for 16 chemicals. By contrast, Canada tests 50 out of every 1,000 products for more than 40 chemicals; Japan tests 110 out of every 1,000 for 57.

This lack of oversight not only leaves the American public vulnerable, but threatens the country’s once-thriving catfish-farming industry. Bill Battle, until recently the president of the Catfish Farmers of America, a trade group, is a tall, plainspoken man. He patrols his farm in the Mississippi Delta, about an hour’s drive south of Memphis, in a brawny 4x4 pickup splattered with reddish mud and dust. At feeding time, the surfaces of his ponds boil with fish gobbling down their daily rations of corn and soybean meal, sprayed from nozzles on the backs of trucks. Battle’s father, who began the operation in 1969, was one of the pioneers in a business that would spread across Alabama, Arfda, Louisiana, and Mississippi, employing 13,000 and generating $16 billion in economic activity. But according to Battle, the good times are over.

In the past year, he has had to sell 500 of his 3,000 acres. The 200 employees at Pride of the Pond have had their time slashed from five to three days a week. And several of his ponds are dry and empty for the first time, their cracked bottoms waiting to be plowed and planted in cotton and soybeans. "This industry is shrinking big-time," Battle tells me. The problem is competition from cheaper, Asia-raised fish. Battle doesn’t begrudge the foreign farmers the advantages of warmer weather and less expensive labor, but he strongly objects to their being allowed to sell fish in this country that are raised with the help of chemicals banned here. "I wouldn’t be cutting back hours, selling land, or draining ponds if the FDA had done their job," he says.

The state of Alabama became so frustrated with the FDA that it initiated its own testing program for imported seafood. The results are cause for concern. According to Lance Hester, director of the Alabama Department of Agriculture and Industries’ food safety section, of the 258 samples tested between 2002 and 2010, nearly half were positive for banned drugs. American producers eventually lobbied to have jurisdiction over the inspection of both imported and domestic catfish moved from the FDA to the US Department of Agriculture, which has a more robust inspection system. The 2008 Farm Bill made this change, but no action has been taken to implement the switchover. Battle suspects that the government is reluctant to let American catfish farmers disrupt trade and diplomatic relations with Vietnam, which supplies more than three-fourths of the catfish imported into the United States. "I guess politics trumps food safety," Battle says. "Apparently, we are going to let [Asian fish] come here and possibly kill people—and certainly kill the industry."

If there is an enforcement arm for food safety in the United States, it’s trial lawyers like Marler, an intense workaholic who estimates that his firm, Marler Clark, has won more than $600 million for clients since he filed his first lawsuits in the early 1990s. In one tongue-in-cheek blog post, Marler suggested that prosecuting executives of food companies that sicken their customers be privatized to him. "I would be willing to put people in jail for poisoning people, and I would do it on the cheap—perhaps for the fun of it," he wrote. Then he listed several existing laws that any moderately competent government prosecutor could use to put executives of wayward food companies behind bars.

In the 1970s the agency conducted 35,000 inspections of food-processing plants each year. Today, it inspects fewer than 8,000, although the number of facilities under its jurisdiction has skyrocketed.

Marler wages his war against contaminated food from lavish offices on the 28th floor of a skyscraper in downtown Seattle. The walls are covered with framed newspaper and magazine clippings chronicling his victories. Given his reputation and plush surroundings, a first encounter with Marler can be disorienting. He favors faded cargo shorts, dress shirts with sleeves rolled up to the elbows, and running shoes that look as if they should have been replaced many, many miles ago. He spikes his conversation with salty language that you’d never hear in a courtroom. And his office is dominated by a stuffed boar’s head, its mouth open to reveal four sharp, curved, four-inch-long tusks—a gift from a satisfied client.

As Marler sees it, the FDA is being slowly starved of the resources and manpower required to fulfill its mandate. In the 1970s the agency conducted 35,000 inspections of food-processing plants each year. Today, it inspects fewer than 8,000, although the number of facilities under its jurisdiction has skyrocketed.

Recognizing that business-as-usual was failing, the FDA began drawing up a plan to improve its performance following a series of outbreaks in 2006, according to David Acheson, who served as associate commissioner for foods at the agency before leaving to become a consultant to the food industry in 2009. The FDA, like many government departments, is linked to the groups it regulates by a revolving door for senior employees. Michael Taylor, the current deputy commissioner for foods, was formerly a vice president of Monsanto. Mitchell Cheeseman, now a Washington, DC, attorney representing food companies, was the acting director of the Office of Food Additive Safety.

Acheson says that the agency has a "huge problem with a lack of personnel, which is a direct consequence of a lack of money." The FDA employs about 1,000 food inspectors, who have to cover 421,000 registered production facilities. The Department of Agriculture, by comparison, has about 7,000 inspectors for about 7,000 facilities. A USDA inspector is present at every operating slaughterhouse or poultry processor. "If you look at the enormous number of places that are growing, processing, manufacturing, holding, distributing, or selling food, versus the number of inspectors at the FDA, inspections simply are not going to happen very often," Acheson says. "This can lead to a get-away-with-it mentality: 'We'll wing it because the FDA won't show up.'"

One reason for this attitude, he says, is that the agency "carries a very small stick" with which to punish violators. "The civil and criminal penalties are not in proportion to the situations that food companies can get themselves into, especially if they have been careless or malevolent," he says.

In 2007, Acheson and a group of associates from within the agency drew up a plan that would radically realign its efforts. Known as the Food Protection Plan, it would shift the FDA’s focus from responding to food-poisoning outbreaks to preventing them. It called for the creation of clear standards and for training food industry personnel on how to meet them. Inspection would play a part, but site visits would be targeted, their frequency based on the risk of a product's poisoning people. "Some products like bananas—because their fruit is packed in a protective skin—are inherently safe," Acheson explains. "Other products, like lettuce, spinach, and tomatoes that are right out of the fields, are less safe. Some places you do need to visit regularly; others you could go in every five years and you would be fine." The plan would also speed up and streamline the agency's response to outbreaks.

The Food Protection Plan became the basis for the Food Safety Modernization Act, which was passed in early 2011 but has not fully taken effect because it has been held up by the White House's Office of Management and Budget—a puzzling delay, since the law is supported by both the food business and the administration. Although the act grants the FDA the power to revoke the registration of an offending company, preventing it from selling its products, sterner civil penalties and higher fines included in some early drafts of the bill were stripped out by legislators, Acheson says. While the law is estimated to cost $1.4 billion over five years for food safety, a proper system would cost $10 billion, Marler estimates, comparing the act to "a sparkling brand-new building that has no people working in it."

The current policy of relying on third-party audits, such as those carried out at Jensen, the Peanut Corporation, and DeCoster, is a "complete and utter joke," in Marler's view. "It's a cover-up. People think it means that inspections occur, but all that's happening is that the skids are being greased to get product to market. Everyone knows it's a scam."

Acheson is more circumspect. He says that with a good auditor, third-party inspections can be effective, but concedes that the lack of oversight causes problems. Marler finds an inherent conflict of interest in the auditing system. Companies that are being inspected pay the inspectors. Those who are too strict will not get repeat business. Lenient ones will always be welcomed. "A better system would be to have public officials do the audits," he says. But that would mean spending more money, which is unlikely in the current climate in Washington. "We just haven't had the size of crisis to hit that critical mass where people are outraged enough to pressure politicians," Marler says.

Or maybe the plague of foodborne illness in this country has yet to affect the right people. "It's mind-boggling," says Paul Schwarz of his family's experience with listeria. "After all my dad gave for this country, the government was not there for him when he needed it. I keep asking, why did it happen to him? To us? The answer is that you never know when it will happen to someone close to you. Nothing is perfect in life, but you can try to do the best you can, and we’re not doing that. Maybe it will take a congressman losing a loved one before food safety gets the attention it deserves."

This article was made possible by the Jonathan and Maxine Marshall Fund for Environmental Journalism

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