The FDA often seems to adopt a “see no evil” approach to potential problems. In 2010, eggs from two Iowa-based companies, Hillandale Farms and Wright County Egg, sickened almost 2,000 people in 11 states with salmonella, a bacterium that can produce fever, stomach cramps, and diarrhea and can result in death. The outbreak led to the recall of 170 million eggs, the largest such recall in American history. When FDA inspectors visited Wright County Egg, owned by Austin DeCoster, in August 2010 after determining that its products were partly responsible for the outbreak, they found barns infested with mice, flies, and maggots. Manure pits were leaking. In some areas, manure was piled eight feet high. Hens used the heaps as ramps to access laying boxes. Wild birds, which are potential carriers of salmonella, fluttered about. The barns were littered with dead, decaying chickens.
What’s shocking is that farms owned by DeCoster were involved in an outbreak that occurred in the Northeast in 1987. The contamination that sickened 500 and killed nine was caused by eggs from farms owned by DeCoster. In the early 1990s, Maryland regulators banned the sale of DeCoster eggs in the state after they were found to be contaminated with salmonella. The company had so many environmental and safety violations that Iowa declared it a “habitual” offender. Despite the red flags, the FDA did not inspect DeCoster’s Iowa barns until after the 2010 outbreak. And when FDA inspectors discovered “serious deviations” from food-safety laws, the agency’s punishment consisted of a warning letter saying that failure to initiate prompt “corrective actions” could lead to “regulatory action being taken.” In November, one month after the letter was mailed, the FDA allowed DeCoster to resume selling fresh eggs.
Following a 2007 salmonella outbreak in which 425 people in 44 states were sickened by peanut butter produced by ConAgra and sold under the Peter Pan and Great Value brands, the FDA intensified its inspection activity at peanut-processing facilities. Unfortunately, the agency missed a plant owned by the Peanut Corporation of America in Blakely, Georgia. It was a deadly omission. In 2008 and 2009, products from that plant sickened 714 people in 46 states and Canada and killed nine. When they did arrive, FDA inspectors found mold on the walls and processing equipment covered in slime.
Investigators for a congressional committee turned up something even more worrisome: internal e-mails indicating that Peanut Corporation’s owner, Stewart Parnell, not only knew about the salmonella at his plant but also ordered products that had tested positive for the bacterium to be shipped. “Turn them loose,” Parnell wrote in one message to a plant manager. He added that results showing contamination would cost the company “huge $$$$$.” In a rare instance of prosecutorial vigor, the FDA, which lacks authority to file criminal charges on its own, teamed up with the Justice Department to pursue a case, yet four years passed before charges were filed. (Parnell has pleaded not guilty.) In the meantime, the lawsuit-besieged Peanut Corporation filed for bankruptcy. “I have never seen a clearer case that demanded criminal prosecution,” says William Marler, a Seattle-based attorney who has represented food-poisoning victims in court for 20 years.
Marler says that during the past 20 years, the FDA has only twice succeeded in pursuing a significant criminal case. In 1998, for example, Odwalla, a fruit-juice bottler based in California, pleaded guilty to 16 misdemeanor charges 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.
The FDA’s responsibilities also include inspecting seafood sold in the United States. Eighty-four percent of it is now imported, and half of the imports are from Asia. Fish farmers there produce huge 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 FDA is charged with keeping drug-tainted fish out of our food supply, but according to a 2011 GAO report, the agency is hardly trying: The FDA tested only one out of 1,000 imported seafood products—or 0.1 percent—for 16 chemicals. By contrast, Canada tests 50 out of every 1,000 products for over 40 chemicals; Japan tests 110 out of every 1,000 for 57.
This lack of oversight not only leaves the American public vulnerable but also threatens our once-thriving catfish industry. Bill Battle, until recently the president of the Catfish Farmers of America, has had to sell over 1,000 of his 3,000 acres in recent years. The problem: competition from cheaper, Asia-raised fish. Battle doesn’t begrudge foreign farmers the advantages of warmer weather and cheaper labor, but he strongly objects to their being allowed to sell fish 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 its job,” he says.
The state of Alabama became so frustrated with the FDA that it initiated its own testing program for imported seafood. Of the 258 samples tested between 2002 and 2010, nearly half were positive for banned drugs, according to Lance Hester, director of the food safety section of the Alabama Department of Agriculture and Industries. American producers eventually lobbied to have jurisdiction over the inspection of both imported and domestic catfish moved from the FDA to the USDA, which has a more robust inspection system. Although the 2014 Farm Bill reauthorized this change, opponents in Congress still seek its appeal. Battle suspects that critics are reluctant to 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,” he 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. As he 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 proposal to improve its performance following a series of outbreaks from 2006 through 2008, according to David Acheson, MD, the former associate commissioner at the agency and now a food-industry consultant. Dr. Acheson says that the agency has a “huge problem with a lack of personnel and resources in general, which is a direct consequence of a lack of money.” The FDA employs about 1,000 food inspectors, who cover 421,000 facilities. The USDA has about 7,000 inspectors for about 7,000 facilities, and 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 are not going to happen very often,” Dr. Acheson says. “This can lead to a get-away-with-it mentality.” He adds that the agency “carries a very small stick” with which to punish violators, although this may be changing.
In 2007, Dr. Acheson and a group of agency associates drew up a plan to radically realign the FDA’s efforts. It would shift the agency’s focus from responding to 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, with frequency based on the risks of a product’s poisoning people. “Some products, like bananas (because the fruit is in a protective skin), are inherently safe,” Dr. Acheson says. “Products like lettuce, spinach, and tomatoes, which are right out of the fields, are less safe. Some places you need to visit regularly, others every five years and you’d be fine.” The plan would also speed up and streamline the response to outbreaks.
This plan became the basis for the Food Safety Modernization Act, which passed in early 2011 but has yet to take effect. The act gives the FDA new authority, including the power to revoke the registration of a company and prevent it from selling its products. Dr. Acheson says that sterner civil penalties and higher fines in early drafts were stripped out by legislators.
Maybe the plague of food-borne illness in this country has not yet affected the right people needed to force real change in the system. “It’s mind-boggling,” says Paul Schwarz Jr. of his father’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.”
Update: In September 2013, Eric and Ryan Jensen—co-owners of Jensen Farms, which supplied the tainted cantaloupe—were charged by federal authorities with introducing adulterated foods into interstate commerce. Both men pleaded guilty, but their attorneys said that did not imply intentional wrongdoing or knowledge that the fruit was contaminated. In January, the Jensens were sentenced to five years’ probation. Paul Schwarz Jr. said while he does not agree with the sentence, he accepts it.