A short-lived federal court case, Del Monte Fresh Produce versus the U.S. Food and Drug Administration (FDA) was 2011’s 5th most important food safety story.
The case was notable for several reasons. Del Monte tried to get a federal judge to question the science of epidemiology and set a standard in which only the “smoking gun” of a positive genetic test proving contamination could be used in closing the U.S. border to foreign food.
Del Monte Fresh Produce filed the case in federal district court in Maryland after FDA issued an “import alert” on cantaloupes grown in any of the approximately 15 fields at the Asuncion Mita farm in Guatemala.
An import alert is a notice allowing a shipment to be stopped at the border without the need to do further inspection.
FDA took the action after the company’s Guatemalan cantaloupes were found responsible for a spring outbreak of Salmonella Panama. At least 20 people in 10 states were infected with the outbreak stain, according to the Centers for Disease Control and Prevention (CDC).
Although Del Monte Fresh Produce voluntarily recalled 4,992 cartons of whole cantaloupes from its fields in Guatemala, the company later claim FDA pressured it into the recall.
If the cantaloupes had been grown in the U.S., it is likely FDA would have inspected the farm and processing facilities just as the agency did with Jensen Farms, the Colorado cantaloupe grower responsible for the year’s deadly Listeria outbreak.
For whatever reason, FDA apparently has never inspected the specific Guatemalan cantaloupe farm. Armed guards turned away two student journalists who tried to visit it.
Usually companies work administratively with FDA to get their products off the import alert list. Instead, Del Monte Fresh Produce filed a 25-page complaint against the agency, claiming that the link between its cantaloupes and the outbreak of Salmonella illnesses was “not rationally supported by the evidence available to FDA.” The complaint also accused FDA of a “clear error of judgment.”
Del Monte Fresh Produce said its own microbiological evidence supported its contention that the imported cantaloupes were not contaminated.
And although Asuncion Mita had not been inspected by FDA, the company’s farm in San Jorge, Guatemala had been visited and the FDA did not issue a document indicating problems there.
The legal actions taken by Del Monte Fresh Produce, and its insistence that it should not be held responsible for an outbreak based on epidemiological evidence, were not taken lightly by the food safety community.
Dr. Tim Jones, the Tennessee state epidemiologist, said the case posed a threat of intimidation that “could have a chilling effect on public health agencies” trying to protect the public health. And Caroline Smith DeWaal, food safety specialist at the Center for Science in the Public Interest, said Del Monte Fresh Produce apparently wanted to make it impossible to issue an import alert in the absence of a positive genetic test indicating contamination.
Del Monte Fresh Produce is the largest importer of cantaloupes to the U.S., and about 27 percent come from Guatemalan.
But just when things were heating up, Del Monte and FDA reached a settlement in which the the company agreed to drop the lawsuit, and FDA agreed to lift the import alert.
The deal did not require FDA inspection of the fields and equipment in Guatemala.© Food Safety News