In an unusual move, Del Monte Fresh Produce has filed suit against the U.S. Food and Drug Administration saying “erroneous speculation, unsupported by scientific evidence” led to a March recall of Guatemalan cantaloupes tied to an outbreak of Salmonella Panama.
The 25-page complaint, filed in U.S. District Court in Maryland, seeks to lift an FDA restriction so the company can resume importing fresh cantaloupes from Guatemala. The suit challenges FDA’s import alerts, which allow the federal regulator to detain, without physically examining, products that either violate or could potentially violate the Food, Drug and Cosmetic Act.
Del Monte is the largest importer of cantaloupes into the United States; about 27 percent of its cantaloupes come from the Guatemalan supplier in question.
In a news release, Del Monte Fresh said FDA and several state health agency officials erred in saying that cantaloupes from a Guatemalan farm and packing facility were likely contaminated with Salmonella. “In fact, neither the FDA nor any state health agency in the U.S. has offered evidence or data to support the FDA action,” the statement said.
On March 22, Del Monte Fresh announced it was voluntarily calling back 4,992 cartons of whole cantaloupes because they had the potential to be contaminated with Salmonella. The recalled melons had been grown and shipped from the Asuncion Mita farm in Guatemala.
The recall was limited to whole cantaloupes sold in plastic sleeves, three to a bag, at “warehouse clubs” in Alaska, California, Colorado, Idaho, Montana, Oregon and Washington. The retailer was not named by Del Monte but later was confirmed to be Costco. Costco notified its customers of the recall; none of the suspect cantaloupes remained in inventory.
Del Monte acknowledged that it had been informed by the FDA that there was an epidemiological link between the cantaloupes and 12 cases of Salmonella Panama infection.
The case count eventually climbed to 13 and then to 20, including three people who were hospitalized with severe illnesses. The Centers for Disease Control and Prevention, in one of its update reports on the outbreak investigation, said 12 of 16 ill people had reported eating cantaloupe in the week before they became ill.
Eleven of those 12 said they had eaten cantaloupes purchased between March 10 and 21 at eight different warehouse-club (Costco) locations, according to the CDC report. Eleven of the case patients were from Oregon and Washington.
The Seattle-based law firm Marler Clark, publisher of Food Safety News, has filed suit against Del Monte Fresh on behalf of some of those sickened. ”I have seen all the documents regarding the outbreak investigation done by the CDC and 10 states, including the traceback records provided by Costco,” attorney Bill Marler said Wednesday. “There is no question that it was Del Monte imported cantaloupe that was responsible for the Salmonella Panama outbreak that sickened 20 last spring.”
But back in March, Phyllis Entis, food safety microbiologist who tracks recalls and outbreaks on her eFoodAlert website, questioned the timing of the recall, because the cantaloupes were beyond their shelf life. In a post republished on Food Safety News, Entis interviewed Bill Keene, senior epidemiologist with Oregon’s Division of Public Health, who acknowledged that the “situation presented quite a dilemma,” both to public health officials and to Del Monte. As Entis wrote:
By the time the outbreak was identified and a probable source determined – which happened rather quickly, thanks to the relative rarity of Salmonella Panama and the Oregon illness cluster – the implicated melons had passed their usable shelf life. There was no point in recalling fruit that was no longer edible.
Why, then, did Del Monte recall the cantaloupes that were sold in Costco stores in several states beginning on March 10? According to Keene, it was unclear whether the outbreak was a “one-off” problem relating to a small quantity of melons from one portion of a single field or whether it was a continuing situation. Del Monte Fresh Produce, therefore, decided on the recall.
Entis concluded that Del Monte’s decision to announce a recall was “a reasonable call.”
Keene, reached Wednesday by email, said, “I don’t recall that there was any serious dispute about the source of the outbreak once all the evidence was on the table.”
Five months later, according to its complaint, Del Monte is arguing that the FDA demanded the company recall its cantaloupes or “suffer the consequences of an FDA consumer advisory questioning the wholesomeness” of its product.
The complaint characterizes FDA’s subsequent action restricting cantaloupe imports from its major source in Guatemala as “unlawful,” and asks the court to prohibit FDA from enforcing the ban.
“The restrictions imposed by the FDA on Del Monte Fresh Produce’s ability to import cantaloupes are unnecessary and not supported by the facts,” vice president of marketing Dennis Christou said in the company’s news release.
In its complaint, Del Monte says its cantaloupes were wrongly blamed for the outbreak. The company gives several reasons for this contention, including:
– FDA and other public health officials concluded that the outbreak illnesses were associated with eating cantaloupes “without ever testing any cantaloupes to determine whether they contained Salmonella.”
– FDA’s conclusion that the suspect cantaloupes were imported by Del Monte from Guatemala was “not rationally supported by the evidence” and “did not take into account evidence that did not support that conclusion.”
– Results of FDA’s tests of cantaloupes from the Asuncion Mita farm — in January just before reports of illnesses surfaced and in April, after the outbreak was reported — were negative for Salmonella.
– FDA has “not adequately accounted for evidence indicating that the outbreak wasn’t caused by cantaloupes at all. For example, one of the case patients denied consuming cantaloupe before becoming ill.”
– FDA has “not adequately accounted for the possibility that any allegedly contaminated cantaloupes came from sources other than Del Monte.”
The complaint says the retailer (Costco) sold cantaloupes from three other suppliers, in addition to Del Monte, but FDA never investigated the other vendors to determine if they were a potential source of Salmonella contamination.
Del Monte also alleges that one case patient reported eating cut cantaloupe, which the company says could not have been Del Monte cantaloupe, while another case patient reportedly ate cantaloupe imported from Honduras, not Guatemala.
Finally, Del Monte charges that FDA has “not adequately accounted for the possibility that any alleged contamination of Del Monte cantaloupes occurred after the melons left Del Monte’s custody.” Contamination could have occurred at the retail level, the complaint suggests.
On July 15, FDA imposed an import alert on fresh, frozen and sliced/chopped cantaloupes from the farm and packinghouse in Asuncion Mita, and that ban is what Del Monte seems most concerned about.
According to the company’s complaint, the import
ban cites FDA’s conclusion that the source of the alleged Salmonella contamination was likely sewage-tainted irrigation water, contaminated wash water, worker hygiene issues, animals in the fields and/or unclean processing equipment. But Del Monte disputes this, arguing FDA not only has “no evidence whatsoever” of any of these assertions, but evidence to the contrary, and thus no statutory authority to bar the Asuncion Mita cantaloupes from the U.S.
Del Monte said it responded to FDA’s concerns by hiring third-party experts to evaluate fields and packinghouse, and that the audit confirmed the Guatemala operations met or exceeded regulatory standards. Additionally, third-party tests of cantaloupe samples from the packinghouse were all negative for Salmonella.
In the company news release, Del Monte’s Christou said, “We require all of our suppliers to comply with all FDA recommended food safety procedures, including the FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, as well as the FDA’s Sanitary Standard Operating Procedures. The farm and packing facility at issue in this case was in full compliance with these food safety procedures.”
Because “significant resources and commitments must be finalized immediately to ensure Guatemalan cantaloupes will be ready for harvest in the near future,” Del Monte asked the court for immediate injunctive relief to reverse FDA’s rule preventing the import of the melons.
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