COUNTRYWIDE DETENTION WITHOUT PHYSICAL EXAMINATION OF PAPAYA FROM MEXICO

Note: Revision to this Import Alert dated 10/17/2012 updates the Guidance section to include procedures for packing facilities seeking exemption from DWPE, and also updates certain FDA office names. Changes are noted and bracketed by three asterisks (***).

Previous revision dated April 20, 2012 provided language to indicate DWPE is only indicated for whole, fresh papaya.

Mexico produces 11% of the worlds production of papayas. U.S. import data from January 1, 2011 shows that approximately 65% of all papayas imported into the U.S. are from Mexico (primarily from the Mexican states of Jalisco, Colima, Chiapas, and Veracruz), which makes Mexico the largest exporter of fresh papayas into the U.S. Evidence shows there is widespread contamination of Mexican papaya with Salmonella, a human pathogen. Based on this evidence, FDA has determined that papaya imported from Mexico appears to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act because the papayas appear to contain Salmonella, an added poisonous or deleterious substance that may render food injurious to health.

FDA has been collecting and analyzing samples of raw, fresh whole papaya imported from Mexico. From May 12, 2011, to August 18, 2011, FDA analysis found Salmonella in 33 samples out of a total of 211, or a 15.6% positive rate. The positive samples were from 28 different firms and include nearly all the major papaya producing regions in Mexico.

In addition, a multi-state outbreak of human infections of salmonellosis occurred in 2011. More than 100 people were infected with the outbreak organism in multiple states. The pathogen, identified as Salmonella Agona, is attributable to a specific, uncommon serotype of Salmonella with an indistinguishable pulsed-field gel electrophoresis (PFGE) pattern by two enzymes.

In the course of the investigation of this outbreak, CDC identified papaya as a likely vehicle. At the same time, State public health agencies conducted interviews of cases to identify the sources of papaya purchased by cases. Using the information provided by the cases, tracebacks were conducted in multiple states. FDA also collected samples of papaya to test for the outbreak strain. Based on information from the outbreak investigation, the outbreak has been associated with papaya from at least one grower and its shipper in Mexico.

Salmonella lives in the intestinal tracts of humans and other animals. The organism may be transmitted to humans by eating foods contaminated with Salmonella from sources of microbial exposure from animals such as birds, mammals and reptiles, or humans. Based on the evidence described above, FDA believes that it is extremely unlikely that the Salmonella Agona outbreak, or the elevated rate of positive samples from FDA¿s recent testing of papayas from Mexico, is due to random contamination events in nature.

Districts may detain, without physical examination, all raw, fresh and raw, fresh refrigerated papaya offered for entry from the country of Mexico, unless exempted (on the Green List).

Detention without physical examination is indicated for whole fresh papaya only. Processed papaya (cut or sliced and packaged; or canned or jarred) is not subject to DWPE.

In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain Salmonella.

FDA has prepared two documents providing options for the testing of papayas associated with the country wide import alert. The documents, both a general instruction document and a qPCR method, can be found at:

http://www.fda.gov/ScienceResearch/FieldScience/ucm231463.htm

If a firm wishes to request removal from detention without physical examination (DWPE), the firm should provide documentation with sufficient evidence that future shipments of their papaya will not be adulterated. FDA may consider five consecutive commercial shipments over a period of time, analyzed as described in the preceding paragraph, as being adequate for removal from DWPE.

*** A firm that packs, repacks, or repackages papayas (often referred to as a packinghouse or packer) from more than one farm may also request removal from DWPE. Requests from these firms should also include information demonstrating that pathogens, such as Salmonella, are adequately controlled during the packing operation.

If removal from DWPE is determined appropriate for the packer, a notation will be made under the packer¿s listing on the Green List of this Import Alert noting the firm¿s status as a packing facility. Papayas from packers on the Green List will be excluded from detention without physical examination if the papaya originate from growers also currently on the Green List of this Alert. ***

Additional information regarding being removed from Import Alert can be found at:

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm

In its request, the firm should forward information supporting its position to FDA at the following address:

Food and Drug Administration
***
Division of Import Operations (DIO) ***
12420 Parklawn Drive,
ELEM - 3109
Rockville, MD 20857

Or via e-mail: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by DIO and then referred to CFSAN for additional evaluation.

For questions or issues concerning import operations, contact *** DIO Import Operations and Maintenance Branch *** at (301) 796-0356.

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

Other questions may be directed to CFSAN, Office of Compliance, Manufacturing and Storage Adulteration Branch (HFS-607) at (240) 402-1620.

Import Alert Language last updated: October, 2012

Papaya, fresh, raw

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

PROBLEM: Salmonella spp.