"Detention Without Physical Examination of Cantaloupes from Mexico"

During 2000, 2001, and 2002, there were four multi-state Salmonellosis outbreaks traced back to Mexican cantaloupes. The pathogen identified in three of the outbreaks was Salmonella Poona and in the other outbreak Salmonella Anatum. Reported cases per outbreak ranged from 35 to 50. There were two deaths in California associated with the 2001 outbreak. At least 18 people were hospitalized. All outbreaks occurred between March and June. FDA's traceback investigations implicated Mexican cantaloupe from the states of Michoacan and Guerrero as the source of the four outbreaks. In 1999, 2001, and 2002, FDA collected samples of Mexican cantaloupes for Salmonella analysis. The salmonella-positive samples include nearly all the major cantaloupe producing states in Mexico including Sonora (7), Jalisco (1), Colima (1), Coahuila (1), Mexico (1), and Tamauilpas (1). Positive samples cover both the fall/winter and spring/summer season.

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 2000, 2001, and 2002, the illnesses were spread over a wide geographical area in the U.S., as well as in Canada, and occurred over a 4 to 6 week period. These two facts also 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 (conducted in response to the outbreaks) at a number of cantaloupe growing areas and packing sheds in Mexico reveal that Mexican cantaloupe are indeed manufactured, processed, or packed under gross 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.

Districts may detain, without physical examination, all raw and raw fresh refrigerated cantaloupes, frozen, and processed cantaloupe, including fresh cantaloupe sliced/chopper for salad bars offered for importation from the country of Mexico.

If a firm, grower, processor, packer, or importer believes that their product should not be recommended for detention under this import alert, they should forward information supporting their position to FDA at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance/Imports Branch (HFS-606)
5100 Paint Branch Parkway
College Park, MD 20740

In order to assess the adequacy of the firm's agricultural, processing, and transportation practices, FDA personnel should review information submitted describing the firm's practices in the following areas:

* Water quality in irrigation, packing, and cooling;
* Manure use and biosolids, animal management;
* Worker health and hygiene;
* Sanitary facilities in field and packing house,
disposal of sewage and Silage;
* Maintenance program for cleaning, sanitizing
equipment;
* Field and packing facility sanitation;
* Transportation;
* If applicable, steps taken to identify and correct
insanitary conditions which are indicated by
positive analytical results for Salmonella in the
firm's product, or as a result of an
epidemiological traceback investigation.

Further details and examples of the types of information that can be submitted can be found in FDA's draft Good Agricultural Practices (FR 63 FR 18029, April 13, 1998).

After reviewing these submissions, FDA, either solely or in conjunction with the relevant Mexican regulatory authority, may conduct a limited number of on-site inspections of the growing/processing areas to audit the validity of the information submitted to FDA. FDA intends to give priority in scheduling these inspections to firms or growers who provide certification from an independent institution or third party that has expertise in agricultural and transportation processes.

On October 26, 2005, the Food and Drug Administration (FDA) and the Mexican Servicio Nacional de Sanidad Inocuidad y Calidad Agroalimentaria (SENASICA) signed a Memorandum of Understanding dealing with Mexican cantaloupe to be imported to the United States. Under the terms of the MOU, SENASICA would identify cantaloupe firms as being in compliance with their Good Agriculture Practices (Lineamientos). This document is similar to FDA's GAPs and will be used by SENASICA to determine if a firm is growing and harvesting cantaloupes under sanitary conditions and can be deemed a Category 3 firm as described in the MOU. Category 3 firms will be listed in the yellow list for this import alert.

The purpose of the Green List is to alert the field to the names of the Category 3 firms certified by SENASICA for which the FDA has agreed to allow to ship. The Category 3 firms named in the yellow list will be required to make five entries and show laboratory results that are negative for Salmonella as described in the MOU. Once they have five shipments shown to be free of Salmonella, the districts should submit a request to DIOP to have the firms moved to the green list for Import Alert 22-01, which exempt the firms from DWPE.

NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of Salmonella to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801 (a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Cantaloupes, fresh, frozen and processed (This includes fresh cantaloupe sliced/chopped for salad bars.)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that such article appears to contain Salmonella, a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section )402 (a)(1)]."

OASIS charge code - SALMONELLA

and

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]."

OASIS charge code - INSANITARY


and

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed, or held under insanitary conditions [Adulteration]"

OASIS charge code - MFR INSAN