During the past two decades, the food industry has taken over much of the FDA's role in ensuring that what Americans eat is safe. The agency can't come close to vetting its jurisdiction of $1.2 trillion in annual food sales.
WASHINGTON — William Beach loved cantaloupe — so much so that starting in June last year he ate it almost every day. By August, the 87-year-old retired tractor mechanic from Mustang, Okla., was complaining to his family that he was fatigued, with pain everywhere in his body.
On Sept. 1, 2011, Beach got out of bed in the middle of the night, put his clothes on and walked into the living room. His wife, Monette, found him collapsed on the floor in the morning. At the hospital, blood poured from his mouth and nose, splattering sheets, bed rails and physicians.
He died that night, a victim of Listeria monocytogenes, a bacterium that can lead to a blood infection and damage to the brain and spinal cord.
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Beach was one of 33 people killed by listeria later traced by the Food and Drug Administration and state officials to contaminated cantaloupes from one Colorado farm. It was the deadliest outbreak of foodborne disease in the United States in almost 100 years.
About seven weeks after Beach started eating cantaloupes, a private, for-profit inspection company awarded a top safety rating to Jensen Farms, the Granada, Colo., grower of his toxic fruit. The approval meant retailers such as Wal-Mart Stores and Wegmans Food Markets could sell Jensen melons.
The FDA, a federal agency nominally responsible for overseeing most food safety, had never inspected Jensen.
During the past two decades, the food industry has taken over much of the FDA’s role in ensuring what Americans eat is safe. The agency can’t come close to vetting its jurisdiction of $1.2 trillion in annual food sales.
In 2011, the FDA inspected 6 percent of domestic food producers and 0.4 percent of importers. The FDA has had no rules for how often food producers must be inspected.
The food industry hires for-profit inspection companies — known as third-party auditors — who aren’t required by law to meet any federal standards and have no government supervision. Some of these monitors choose to follow guidelines from trade groups that include ConAgra Foods, Kraft Foods and Wal-Mart.
The private inspectors that companies select often check only those areas their clients ask them to review. That means they can miss deadly pathogens lurking in places they never examined.
What for-hire auditors do is cloaked in secrecy; they don’t have to make their findings public. Bloomberg Markets magazine obtained four audit reports and three audit certificates through court cases, congressional investigations and company websites.
Six audits gave sterling marks to the cantaloupe farm, an egg producer, a peanut processor and a ground-turkey plant — either before or right after they supplied toxic food.
Collectively, these growers and processors were responsible for tainted food that sickened 2,936 people and killed 43 in 50 states.
“The outbreaks we’re seeing are endless,” says Doug Powell, lead author of an Aug. 30, 2012, study on third-party monitors called “Audits and Inspections Are Never Enough.” Powell, a professor of food safety at Kansas State University, says Americans are at risk whenever they go to a supermarket.
In some cases, for-hire auditors have financial ties to executives at companies they’re reviewing. AIB International Inc., a Manhattan, Kan., auditor that awarded top marks to producers that sold toxic food, has had board members who are top managers at companies that are clients.
Executives of Flowers Foods, which makes Tastykake, and Grupo Bimbo in Mexico City, which makes Entenmann’s pastries, Sara Lee baked goods and Wonder Bread, serve or have served on AIB’s board.
As flawed as the inspection system is in the U.S., it’s more problematic with imported food, especially coming from countries with lower sanitary standards, says Michael Doyle, director of the University of Georgia’s Center for Food Safety. In some emerging markets, farms growing food for export to the U.S. aren’t inspected at all.
The U.S. will import half of its food by 2030, up from 20 percent today, Doyle says. Bloomberg Markets visited growers in China, Mexico and Vietnam and found unsanitary conditions for produce, fruit and fish exported to the U.S.
The FDA is trying, so far without success, to wrest back control of food inspection from the industry. In 2008, the agency estimated it would need another $3 billion — quadrupling its $1 billion annual budget for food safety — to conduct inspections on imported and domestic food, the FDA’s former food safety chief David Acheson says.
Instead, the food industry lobbied for, and won, enactment of a law in January 2011 that expanded the role of auditors — and foreign governments — in vetting producers and distributors of food bound for the U.S.
The Food Safety Modernization Act, which passed Congress with bipartisan support, will allow the FDA to certify private companies to audit producers of imported food on its behalf.
The law mandates these auditors submit their reports to the agency. These rules don’t apply to domestic inspection companies, which still won’t be approved by the FDA and don’t report their findings.
Under the 2011 law, the FDA will require high-risk producers to be inspected every five years starting in 2016, according to the agency’s website.
Sometimes, what passes for inspection in the food industry isn’t inspection at all; it’s more like bookkeeping.
In many cases, auditors award top safety ratings without testing production facilities for bacteria, says former auditor Jeffrey Kornacki, who now owns Kornacki Microbiology Solutions, a microbiology consulting company in McFarland, Wis.
Sometimes, auditors don’t set foot in production areas of the companies they report in audits as safe, Kornacki says. “Most companies won’t let third-party auditors look for pathogens,” Kornacki says. “They don’t want your results shutting them down.”
Auditors evaluate their clients using standards selected by the companies that pay them, says Mansour Samadpour, owner of IEH Laboratories & Consulting Group in Lake Forest Park, Wash., which does testing for the FDA. The auditors sometimes follow a checklist that the company they’re inspecting has helped write.
“If you have a program for adding rat poison to a food, the auditor will ask, ‘Did you add as much as you intended’ ” Samadpour says. “Most won’t ask, ‘Why the hell are we adding poison?’ “
Not only has the government outsourced auditing to the food industry; the auditors themselves often outsource their vetting to independent contractors — people over whom they don’t have direct management control.
It was such a contractor who blessed the cantaloupes at Jensen Farms in Colorado shortly before the melons would sicken 147 Americans and kill 33 others, including William Beach.
On July 25, 2011, Santa Maria, Calif.-based Primus Group Inc. — whose PrimusLabs unit bills itself as the largest produce-safety company in the Western Hemisphere — sent a subcontractor to Jensen Farms. The property, 181 miles southeast of Denver, was then a mosaic of fields where trucks churned up dust clouds on dirt roads and cantaloupes grew beneath power lines.
The subcontractor, Bio Food Safety of Rio Hondo, Texas, was represented by James Dilorio, who spent four hours on site. Using a checklist, he documented practices such as the cleaning of cantaloupes, washing of employees’ hands and labeling of detergents, according to his report.
Dilorio scored Jensen 96 out of 100.
“Yes, all food contact surfaces are clean,” his report says. “Yes, all products and food contact packaging were within acceptable tolerances for spoilage or adulteration.”
By the time Dilorio gave his stamp of approval to Jensen, William Beach had already been eating cantaloupe from the farm almost every day for seven weeks. Beach died on Sept. 1, one day before the Colorado Department of Public Health and Environment alerted the federal CDC in Atlanta that patients throughout the state were falling ill with listeriosis. Beach’s infection was caused by the listeria-tainted cantaloupe, according to the Oklahoma State Department of Health.
Acting on reports from several people who said they got sick after eating Rocky Hill brand cantaloupe — grown in southeastern Colorado — state and FDA inspectors went to Jensen Farms on Sept. 10, 2011. They collected 13 samples from the Jensen processing line and packing area that tested positive for listeria.
The FDA found that the equipment used to clean the fruit may have spread listeria. On Sept. 14, 2011, Jensen announced a 17-state recall of cantaloupes.
While PrimusLabs declined to comment directly, it did supply a response from its law firm, Kaufman Borgeest & Ryan in New York. Auditors, the statement says, serve at the pleasure of their clients and cannot go beyond what they are asked to do.
In 1938, after more than 100 people died from the antibiotic sulfanilamide, Congress passed the Food, Drug and Cosmetic Act, strengthening the FDA. For the first time, a federal agency had the power to inspect, approve or reject all food and pharmaceutical products.
From the outset, though, the FDA lacked the resources to inspect all of the country’s food producers.
The food industry moved to fill that vacuum with private auditors in the 1990s. Danone SA, Kraft, Wal-Mart and other companies created the Paris-based Global Food Safety Initiative in 2000 to write guidelines for third-party auditors.
The program, whose vice chairman is Frank Yiannas, Wal-Mart’s vice president for safety, requires companies to be audited once a year. It doesn’t mandate testing for pathogens. In 60 manufacturing plants, Wal-Mart suppliers reported a third fewer recalls in the two years after adopting GFSI standards, Yiannas says.
In some cases, companies use their own auditors to check suppliers. In 2002 and 2006, Nestle USA, a subsidiary of Vevey, Switzerland-based Nestle, refused to use Peanut Corp. of America as a supplier. Nestle inspectors found rodent carcasses and pigeons in Peanut Corp.’s Plainview, Texas, plant.
Nellie Napier, an 80-year-old grandmother of 13 living in a long-term-care facility in Medina, Ohio, frequently ate peanut butter to help regulate her blood sugar.
On Jan. 9, 2009, she was admitted to Summa Barberton Hospital in nearby Barberton, with salmonella raging in her blood, according to her medical records. Her kidneys shut down, and she died on Jan. 26, 2009.
Napier was a victim of an outbreak that sickened 714 people and may have contributed to nine deaths in 46 states, according to the CDC. In January 2009, FDA inspectors visited the Blakely plant and found dead cockroaches in a washroom and water stains from skylights above a packing line.
“Proper precautions to protect food cannot be taken because of deficiencies in plant construction,” the FDA wrote on Jan. 27, 2009. The next day, Peanut Corp. recalled all peanut products the plant had made for nearly two years.
AIB, the Peanut Corp. auditor, says on its website that the Blakely plant lacked an on-site manager for four months after its 2008 audit — enough time for conditions to deteriorate.
Maureen Olewnik, AIB’s vice president for auditing, says Peanut Corp. didn’t show it all of its procedures and areas.
Peanut Corp. is now defunct, barraged by dozens of civil lawsuits and a Department of Justice criminal investigation.
Flaws in the U.S. inspection system are magnified when food originates in other countries. In Mexico, some fields contaminated by animal and human feces and dirty water aren’t being monitored by government inspectors or third-party auditors.
Almost half of the vegetables and 26 percent of the fruit imported into the U.S. last year came from Mexico, the U.S. Department of Agriculture’s Economic Research Service says.