Import Alert 22-01: Detention without physical examination of cantaloupes from Mexico

Salmonella lives in the intestinal tracts of humans and other animals. Thus, the organism may be transmitted to humans by eating foods contaminated with fecal material from humans or other animals. Random events in nature, such as animal defecating on a cantaloupe growing in the field, may cause the product to become contaminated with Salmonella and, subsequently, result in illness. However, FDA believes that it is extremely unlikely that there would be repeated multi-state outbreaks of salmonellosis, attributable to a specific species of Salmonella with indistinguishable pulse field gel electrophoresis (PFGE) patterns if contamination was derived from random events in nature.

Moreover, in the outbreaks of the early 2000s, the illnesses were spread over a wide geographical area in the U.S., as well as in Canada, and occurred over a 6-week period. These facts suggest that more than one shipment was the cause and make it extremely unlikely that a random natural event or events caused the contamination.

FDA believes that the source of Salmonella contamination is most likely attributable to a broader source of contamination. Sources of contamination may include irrigation of fields with water contaminated with sewage, processing ("cleaning and cooling") produce with Salmonella contaminated water, and/or poor hygienic practices of workers that harvest and process the produce, pests in packing facilities, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product.

Inspectional findings at a number of cantaloupe growing areas and packing sheds in Mexico revealed that Mexican cantaloupe are indeed manufactured, processed, or packed under insanitary conditions. Further, these inspections underscore the lack of an overall environmental sanitation program, as well as apparent lack of regulatory authority in Mexican law to address the insanitary conditions that FDA believes lead to Salmonella contamination. In addition, practices that result in product from different states being commingled means that any shipment of cantaloupe may contain fruit from states that have been the source of contaminated cantaloupe.

FDA believes that cantaloupe imported from Mexico appear to be adulterated under Section 801(a)(3) of the Act because they appear (1) to contain Salmonella, an added poisonous or deleterious substance that may render food injurious to health within the meaning of section 402(a)(1) of the Act and (2) to have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health within the meaning of Section 402(a)(4) of the Act. In addition, the cantaloupe violate section 801 (a)(1) of the Act in that they appear to have been manufactured, processed, or packed under insanitary conditions.

This alert covers both whole cantaloupe and sliced, chopped, or diced cantaloupe. The processing associated with producing fresh versus intact produce increases the opportunity for contamination and the chance of cross contamination over an even larger volume of product.

Furthermore, processes such as cutting, dicing, and slicing, increase the surface area available for contamination and growth of microorganisms. Nutrients to support microbial growth (i.e., from plant juices and exposed flesh) are also more available. Concerns about pathogens are further amplified when the characteristics of the particular fruit or vegetable (e.g. pH) can support their growth. This is the case with many vegetables, certain soft fruit, and melons, including cantaloupe.