In an attempt to overturn a U.S. Food & Drug Administration “Import Alert” that effectively prevents Del Monte Fresh Produce N.A. Inc. from importing cantaloupes from its Guatemalan supplier, the produce company filed a lawsuit Aug. 22 against the federal agency in U.S. District Court in Maryland.
Del Monte Fresh Produce, which is headquartered in Coral Gables, FL, and which is a subsidiary of Fresh Del Monte Produce Inc., is seeking an injunction against the FDA Import Alert No. 22-03, which was issued July 15. The alert stemmed from a multi-state outbreak of Salmonella Panama infections in February and March of this year.
At that time, an FDA investigation found that there were 13 cases of Salmonella infections in five states that were seemingly related. The FDA concluded in its traceback investigation that the source of contamination was most likely at the field level caused by contaminated water, poor hygienic practices of workers that harvest and pack the produce, animals in close proximity to product or water sources, and/or a lack of adequate cleaning and sanitizing of the equipment that comes into contact with the product.
The alert was specific to Asuncion Mita in Guatemala, which is the farm and packingshed that provides Del Monte with cantaloupes from that region. The alert officially gave the FDA the right to “Detention Without Physical Examination of Cantaloupes from Asuncio Mita in Guatemala.”
In its lawsuit, Del Monte contends that the FDA’s claims are based on erroneous speculation, unsupported by scientific evidence, that cantaloupes previously imported by Del Monte Fresh from this Guatemalan farm and packing facility were contaminated with the pathogen Salmonella. In the suit, Del Monte asserts that neither the FDA nor any state health agency in the United States has offered evidence or data to support the FDA action.
“Del Monte Fresh Produce places the highest priority on food safety and protecting customers,” Dennis Christou, Del Monte’s vice president marketing-North America, said in an Aug. 24 statement released by the firm. “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. The restrictions imposed by the FDA on Del Monte Fresh Produce’s ability to import cantaloupes are unnecessary and not supported by the facts.”
In issuing the alert, the FDA justified it by stating that its traceback investigation did find that Asuncion Mita in Guatemala was the source for each suspected carton. The FDA also concluded that it was “extremely unlikely that this outbreak of Salmonellosis is due to an isolated event in the field or in the packinghouse.”
The suspect cantaloupes were believed to have been packed over a 19-day period in January and had different pack dates, shipping dates and lot codes.
The alert allows any FDA district to “detain, without physical examination, all raw fresh and raw fresh refrigerated cantaloupes, frozen and processed cantaloupe, including fresh-cut cantaloupe (i.e., sliced/chopped), offered for importation that appear to originate from” Asuncion Mita.
The alert does note that “if a firm believes that its product should not be subject to detention under this import alert, the firm should forward information supporting its position to FDA.”
In fact, Del Monte did voluntarily recall almost 5,000 cartons of cantaloupes in the United States that were imported from Asuncion Mita in late March when the FDA notified the firm that there was an “epidemiologic link” between those cantaloupes and the Salmonella outbreak. The company also put a hold on production and distribution from that firm while both the company and the FDA continued the investigation.
In its lawsuit, Del Monte revealed that it responded to the concerns raised by the FDA by conducting its own analysis and a third-party audit to determine whether its food-safety procedures required enhancements. The farm, packingshed and the exact fields where the allegedly contaminated cantaloupes were harvested were audited. The firm said that the audit revealed that the farm was in compliance with Good Agricultural Practices and, in fact, exceeded those practices.
In addition, Del Monte said that it requested the third-party experts to establish a rigorous pre-importation test-and-hold program for lots of cantaloupes shipped from the Asuncion Mita farm from the time of the limited recall until the end of the growing season.
Under the program, samples were taken from packed product before it left the packinghouse and were tested for the presence of Salmonella by an ISO-certified laboratory in Guatemala City. The third-party experts concluded that all such samples tested negative for any Salmonella species.
Subsequently, Del Monte has examined the evidence gathered by the FDA to implicate Asuncion Mita and has found it to be lacking.
In its legal complaint, Del Monte argues that FDA reached its conclusion about contaminated cantaloupes “without a sufficient factual basis to support the conclusion. Among other things, on information and belief, these officials reached this conclusion without ever testing any cantaloupes to determine whether they were contaminated with Salmonella.”
The complaint further states that the link to the exact farm in Guatemala and the Salmonella outbreak “was not rationally supported by the evidence available to FDA. FDA also did not adequately take into account evidence that did not support that conclusion. In addition, FDA’s conclusion was a clear error of judgment.”
Del Monte claims that the “FDA’s actions adversely affect Del Monte Fresh’s ability to receive perishable fresh produce for sale to its customers in the United States, as the import alert threatens the viability of a major import source for cantaloupes. Since significant resources and commitments must be finalized immediately to ensure that Guatemalan cantaloupes will be ready for harvest in the near future, Del Monte Fresh is seeking immediate injunctive relief from the court.”