Millions of children and adults ate their Cheerios over the past several months with bananas or blueberries, sugar or honey, whole or skim milk, and an unexpected, added ingredient -- an illegal pesticide.
The Food and Drug Administration and the Environmental Protection Agency have determined that the chemical, chloropyrifos-ethyl, which had been sprayed on oats used to make 16 popular General Mills Inc. cereals, did not pose a public health risk. The chemical is approved for and widely used on other food products, such as apples, bananas, beans and wheat in the fields. But approval has not been sought for its use on stored grains.
This Cheerios story shows how popular food products that have been adulterated can escape detection and reach millions of consumers. General Mills said 110 million boxes of its cereals made with the illegally sprayed oats were sold because of a tear in the food safety net that worries government officials responsible for protecting the food supply.
Even if the pesticide had been deadly, instead of illegal but safe, it probably would not have been caught before it appeared on grocers' shelves, according to food safety experts.
"It's one of the nightmares I have," said L. Robert Lake, director of policy and planning for the Center for Food Safety and Applied Nutrition at FDA. "It could easily have been a more toxic chemical."
Equally troubling is the question of how the actions of one man went undetected by General Mills, a food industry giant with sales last year of $8.52 billion and a good reputation for safety. The company, which spent $258 million last year on quality control, did not test for pesticide residues in its cereal because "we have never had a problem with pesticide residue," said spokesman Austin Sullivan.
Y. George Roggy, a subcontractor of General Mills, was charged last week in Minnesota with knowingly misusing the pesticide, called Dursban commercially. Dursban was cheaper than a similar one approved for use on oats, and Roggy allegedly saved $85,319 by using it for about a year and billing General Mills for the more expensive, legal chemical.
Prosecutors in Minnesota said their investigation is continuing and General Mills is cooperating.
"The basic responsibility {for food safety} is really with the industry ... with the growers and applicators and food companies," said Lake. "One of the things bothersome to us about the General Mills incident is it went on for an extended period of time and they didn't know. It means they didn't have a good system for checking oats."
Said General Mills Vice Chairman Joe R. Lee: "We make great efforts to make our products nutritious, safe and wholesome. In this case, it didn't work... . Fortunately, it had no safety impact."
FDA's monitoring of the food supply for illegal pesticides is, at best, random, said Lake and others. In fact, it was nothing short of a miracle that the Dursban was found in the General Mills oat supply at all.
This account of how the pesticide was discovered and decisions made about how to respond was compiled from interviews with more than a dozen officials of the FDA, EPA and the office of the Minnesota Agriculture Commissioner.
The FDA is responsible for monitoring the food supply for pesticide residues and acts as regulator. The EPA registers pesticides and determines what they can be used for.
General Mills provided some information, although the company refused to let a reporter visit its cereal-making facilities in Minneapolis and declined to make its food safety experts available.
On May 11 and 12, FDA field agents from the Kansas City district collected routine samples of oats from grain elevators in Des Moines. Nearly a month went by while the samples were analyzed by the FDA regional lab in Dallas, the findings communicated to the Kansas City, Kan., office, and the source of the Des Moines oats traced to General Mills, known in its home town of Minneapolis as "Big G."
Dursban, widely used in a host of products, including flea powders for dogs and cats and indoor pest sprays for spiders, ticks and termites, is not approved for use on any stored grains.
When further tests confirmed that General Mills' oats had been sprayed with the pesticide, alarm bells started going off. The company was notified by fax and telephone of the FDA's finding on Friday, June 10.
"We were surprised," said Sullivan. "Our reaction was that we don't use that chemical."
The company immediately stopped using oats and oat flour and cut off distribution of all its oat products. Toxicologists began testing the company's oats. By Saturday morning, officials of the company said, they were 95 percent certain there were no health dangers to the public from the pesticide residue.
On Sunday, June 12, three General Mills officials, including the company's director of security, interviewed Roggy, who admitted he had used Dursban for about 13 months instead of its approved chemical cousin, chloropyrifos-methyl (known commercially as Reldan), because he had financial difficulties and Dursban was cheaper.
Asked what kind of agreement Roggy, head of Fumicon Inc., had with the company, Sullivan replied that he didn't think there was a written contract. "He was just somebody we used from time to time," he said.
Roggy, licensed by Minnesota to spray pesticides, worked without supervision, spraying oats as they came off ships into General Mills' grain storage elevators in Duluth, Minn., and Superior, Wis. Not all of the company's oats were sprayed -- only those that were going into long-term storage in anticipation of the days when the Great Lakes would freeze and ships would be unable to deliver their cargo.
Still, Roggy managed to spray Dursban on 16.8 million bushels of oats, some of which the company used to make 160 million boxes of breakfast cereals such as Cheerios, Lucky Charms, Booberry and Trix. Most of the cereals made from oats sprayed with Dursban were shipped to grocery stores in March. By the time the company found out about the illegal spraying, 110 million boxes were on the shelves in grocery stores and consumers' homes.
"Normally, when there's a foul-up on food production, it's caught much earlier in the game," said FDA's Lake. "Usually the company discovers it and initiates a recall on its own... . But the magnitude of this was much larger than anything else we'd seen... . People had already fed it to their children."
Cheerios are often one of the first solid foods eaten by children, and are favored by parents and pediatricians because they are easy to swallow and not heavily sugared like some cereals.
And the product is ubiquitous. Virtually every federal official who talked about the case mentioned that his or her children eat Cheerios. When a group of parents recently filed a class-action suit in Chicago against General Mills for consumer fraud because of the pesticide use, Judge Dorothy Kirie Kinnaird recused herself, saying she and her family eat Cheerios all the time and she couldn't be unbiased in such a case.
On Monday, June 13, EPA and FDA officials in Washington began to address the question of whether they had a public health emergency on their hands.
"Our first concern was: Do we need to do something about the Cheerios people already have?" said Dr. Lynn Goldman, assistant administrator for prevention, pesticides and toxic substances at EPA. "We didn't want to raise an alarm for no good reason and scare people, but we didn't want to fail to warn them either."
Both agencies immediately asked the company for the results of its tests. How much of the pesticide residue was present in the cereal? In addition, the agencies' scientists did their own tests, buying about 200 boxes of cereal off grocers' shelves around the country.
"Virtually all the samples but one were okay," said Stephen L. Johnson, the EPA's director of pesticide registration. "We didn't believe there would be any harmful effects to people."
Johnson said that in much, much greater levels of residue, Dursban could cause headaches, nausea, vomiting, diarrhea and loss of balance.
The two government agencies decided not to press the company to recall the cereal. "We were concerned that a recall would have been very disturbing to parents who had already fed their children Cheerios," said Lake. "We didn't want to cause a public panic."
On Wednesday, June 15, after three days of intense meetings and consultations between the government and the company, FDA alerted news organizations that the oat products had been sprayed with chloropyrifos-ethyl, but that the oats "do not present a health hazard."
The company notified grocers, who continued to sell the products.
The company had stopped production while it brought in a new supply of oats, but once it resumed making cereal it found there was still pesticide residue in its equipment.
"We shut down the plants and literally disassembled the machinery to get it out of every nook and cranny," said Sullivan. As a result, many grocery stores, including some in the Washington area, have run out of affected brands.
But there was another question. General Mills had on hand an additional 50 million boxes of cereal made from oats that had been sprayed with Dursban. It also had about 15 million bushels of oats remaining that had been sprayed. The company had decided that it would not use the raw oats for human food. But since regulators had found no health hazard from the chemical, would FDA agree to let the company sell the 50 million boxes of cereal?
"We didn't want to send a signal to the company that it's okay to violate the law as long as it doesn't hurt anybody," said Lake. In addition, FDA was worried that foreign countries that ship grains to the United States would expect the same treatment as General Mills.
"So we had to say no," he said.
The company was told it could apply for a temporary approval of the use of Dursban on oats from the EPA. After submitting the petition, however, General Mills found that the process would take so long that even if it was approved, "the cereal would have been out of date. It would have been stale," said Sullivan.
Several organizations contacted the government about the possibility of sending the cereal to help feed Rwanda's hungry children. The idea was determined to be impractical: Cereal is low-density nutrition, expensive to ship. In addition, "we would not have wanted to pick up the paper and read: 'Poison Cereal Dropped on Rwanda,' said Lake.
The idea was abandoned.
General Mills will take a write-off against earnings of as much as $87.5 million because of the Dursban application, according to Sullivan. The company is currently disposing of 50 million boxes of Cheerios in landfills and incinerators under the watchful eye of the Minnesota office of the FDA. It is working with the EPA on the question of whether the 15 million bushels of sprayed oats it still has can be used as animal feed.
The company has revamped its safety procedures at the FDA's request. Among the changes: Raw oats are now regularly tested for pesticides; General Mills will provide contractors with pesticides and monitor their work; it will expand its lab facilities and add a new grain quality manager.
Roggy, who has pleaded not guilty to criminal charges, faces a criminal trial and a sentence of up to eight years in prison if convicted. In addition, Minnesota has called for a hearing to review his license to spray pesticides and may bring its own criminal or civil charges.
"There is one thing that the government, General Mills and Mr. Roggy all agree on," said John W. Lundquist, Roggy's attorney. "The product was completely safe... . The problem is it doesn't appear on the government's list of approved pesticides. The dispute is over whether that justifies the prosecution of an individual and the dumping of millions of bushels of oats."
Meanwhile, the company believes the supply of cereal made from oats sprayed with Dursban is virtually out of the pipeline, though some rural stores may still have some on their shelves.
General Mills has "a very good {safety} program, one of the best in the industry," said Lee, the company's vice chairman. "It still didn't catch ... someone who willfully lied about what he was using... . We have great confidence that now we'd catch it."