Mexico's Cofepris Says the FDA's Investigations Into Salmonella Javiana and Cyclospora Do Not Prove an Origin in Mexican Products

Mexico's Federal Commission for the Protection against Sanitary Risks (Cofepris) published on October 3 an information card on the closure of two investigations by the United States Food and Drug Administration (FDA), one into an outbreak of Salmonella Javiana and another into an outbreak of Cyclospora cayetanensis. According to the document, the FDA reported the conclusions of both cases on October 2. The Ministry of Health and Cofepris maintain that, with the information available at closure, it is not possible to establish through conclusive analytical evidence that Mexican agricultural products were the source of the outbreaks.

In the Salmonella Javiana case, Cofepris recalls that laboratory results did not identify the bacterium in any of the environmental samples collected during the investigation, and that the FDA itself acknowledges in its final report that it was not possible to determine the route or source of contamination. The investigation was declared concluded. Earlier, the Mexican authority had reported that all samples analyzed at an investigated jalapeño pepper packing house tested negative for that bacterium.

In the Cyclospora case, the FDA reported two positive results in environmental samples taken in Mexico: one in outflow wastewater from a processing plant and another in a drainage ditch of a production unit. The US agency indicates that there is not enough evidence to determine conclusively how the contamination occurred. Cofepris clarifies that these environmental findings do not, by themselves, constitute evidence that the agricultural products were the source, and recalls that previous analyses by its National Reference Laboratory of raw material, finished product and water from the investigated plant were negative for Cyclospora. The epidemiological and traceability elements and the environmental findings remain under analysis, and Mexico reiterated its willingness to cooperate with the FDA, the CDC and other authorities.

For vegetable exporters, the episode shows that environmental findings and traceability weigh as much as finished product testing in attributing an outbreak, and that a documented verification plan supports a plant's defense before a buyer or a regulator. For Salmonella spp. in leafy greens, TAAG's Ampliora 3.9 kit, a real-time PCR, also detects STEC and E. coli O157:H7 in lettuce, spinach, cabbage and leaf mixes. It does not include jalapeño pepper and does not detect the parasite Cyclospora, so it serves only as partial support for the bacterial component.