Del Monte Fresh Sues FDA to Invalidate Cantaloupe Import AlertAugust 23, 2011
By Ricardo Carvajal –
Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. ("PAO"), a Guatemalan producer that is one of Del Monte Fresh’s principal suppliers. FDA imposed the import alert as the result of a multi-state outbreak of Salmonella Panama that FDA attributed to PAO cantaloupes. The complaint alleges that FDA’s conclusion regarding the likely source of the outbreak “was not rationally supported by the evidence available to FDA,” and that “FDA also did not take into account evidence that did not support that conclusion.” In specific, the complaint alleges that all tests of PAO cantaloupes for Salmonella or other pathogens have been negative, that FDA inspections and other audits of PAO have been satisfactory, and that some evidence suggests that the outbreak may have been caused by cantaloupes from other sources or foods other than cantaloupe. Thus, if the case proceeds, it will likely focus on the sufficiency of the epidemiological evidence relied on by FDA. Given the increasing sophistication of (and reliance on) epidemiological investigations in responding to outbreaks of foodborne illness, that makes this a case to watch.