Del Monte’s legal cannon shot fired at the U.S. Food and Drug Administration and the Oregon Public Health department over the past week was heard clearly by food safety officials around the country, from Washington state to Washington D.C. And they don’t like what they hear.
Public health authorities and consumer activists described the complaint filed by Del Monte Fresh Produce as an attempt to intimidate food safety programs across the country.
But experts close to the food industry described it as one large corporation declaring: “Enough is enough.”
Either way, the lawsuit is a response to a finding by the FDA earlier this year that a Salmonella Panama outbreak that had sickened 20 people in 10 states was likely caused by contaminated cantaloupes grown in Guatemala and imported by Del Monte Fresh Produce.
At the time, the Florida-based company voluntarily recalled nearly 5,000 cartons of cantaloupes, and since then the FDA has banned further cantaloupe imports from the company’s site in Asuncion Mita, Guatemala.
However, public health authorities never established a positive match — a genetic “fingerprint” — linking Del Monte’s cantaloupes to the Salmonella infections. Instead, the investigation was based on established epidemiological procedures — interviews with the victims and a process of elimination that concluded there was a high probability that cantaloupes were the culprit. Traceback information from Costco indicated the suspect brand was Del Monte Fresh Produce.
The company’s 25-page complaint, filed in Maryland, questions the findings of that investigation and seeks to lift the FDA’s restrictions on cantaloupe imports from Guatemala. And it challenges the federal import alert, which empowers FDA to detain goods without physical examination, and requires the company to show its melons are safe.
The company also served notice it will sue Oregon Public Health, and senior epidemiologist Dr. William Keene, who was one of several investigators from different states who worked on the case last March.
Del Monte Fresh Produce’s complaint says the FDA forced it to recall its cantaloupes or “suffer the consequences of an FDA consumer advisory questioning the wholesomeness” of its product. The subsequent ban on imports is unlawful, the company claims, because it is not supported by the facts.
The company now claims its cantaloupes were wrongly blamed for the outbreak.
One lawyer who represents U.S. companies in food poisoning cases said companies like Del Monte are frequently frustrated with being forced into costly recalls despite a lack of what they consider to be conclusive evidence.
Companies are notified by the FDA with little or no warning, explained the lawyer, who asked not to be quoted by name. “”You get a day or two heads-up that it appears to be your product, and there is not much opportunity to have a conversation … There is not enough collaboration, and it comes across as not even-handed.”
Keene, in particular, has antagonized companies with his outspoken style, the lawyer said.
However, food safety advocates pointed out that the public health system is primarily responsible for protecting consumers, not companies.
“Del Monte appears to be asking for the almost impossible before the FDA can issue an alert,” warned Caroline Smith DeWaal, a lawyer and food safety specialist at the nonprofit Center for Science in the Public Interest. “The company wants the FDA to require a smoking gun, a positive genetic test, before taking action. That is unrealistic and it puts a burden on investigators that is unmanageable.”
Dr. Tim Jones, the Tennessee state epidemiologist, does not expect the case to go far. “But just the threat could have a chilling effect on public health agencies.”
Health departments should not be immune from lawsuits, Jones said. But Keene is an example of a public servant who is also a disciplined scientist. “He is outspoken, but his comments are always justified,” Jones said. “It’s not a matter of cockiness. His job is to protect the public and that is what he tries to do. He is one of a small group of people willing to be blunt and honest with the industry, and I trust what he says.”
He and others stressed that Keene and others employ investigative tactics that are statistically sound and fully tested after many years of epidemiology.
When they can, authorities use genetic fingerprinting, the popular term for pulsed field gel electrophoresis, or PFGE, to establish a virtually certain link between an outbreak of illness and a specific food. But PFGE is limited because investigations usually occur weeks after the outbreak, and perishable food is likely to have been either consumed or discarded, making it impossible to test for contamination.
Keene explained the problem earlier this year in an interview with Food Safety News. “It would be great if we could just buy the product, take it to the lab and find Salmonella,” he said at the time. “That’s something anybody can understand. But when you offer up P values and probabilities, people want to say: ‘That’s just statistical mumbo jumbo.’ “
In fact, epidemiologists have been tracking outbreaks for decades by interviewing victims, looking for foods that all or most of them have consumed, and employing basic statistics to zero in on a probable source.
Statistically, those findings can be just as powerful and persuasive as the lab results, according to food safety experts.
Their credibility was damaged, however, by the 2008 Salmonella outbreak that was originally blamed on tomatoes in a Mexican salsa, but later turned out to be peppers used in the same salsa. That error cost the tomato industry millions of dollars, and soured relations between the food industry and health agencies.
“I still don’t think the wrong thing was done there,” said Jones of the tomato misidentification. “There were nuances over how information was communicated. But no one was being malicious or irresponsible. We would not be able to live with ourselves if a child died from food poisoning in the three days that we dilly-dallied around looking for that last piece of conclusive evidence.”
Americans contradict themselves, he said, in that they “want their food to be 100 percent safe and they get angry when it isn’t…. and they also want 100 percent conclusive evidence before issuing a recall.”
(Marler Clark, the food safety law firm that sponsors this site, has filed suit against Del Monte Fresh Produce on behalf of several people sickened in last spring’s Salmonella outbreak.)