"DETENTION WITHOUT PHYSICAL EXAMINATION OF PAPAYA FROM MEXICO"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 01/10/2023 updates title to current standard format, update standard language, clarifies firm listings "note section" found in guidance section, and updates agency contacts. Changes to the import alert are bracketed by asterisks (***). 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.

Product Description

Papaya, fresh, raw

Charge

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

Guidance

Divisions 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 (DWPE) is indicated for whole fresh papaya only. Processed papaya (cut or sliced and packaged; or canned or jarred) is not subject to DWPE. ***Release of Articles Subject to Detention without Physical Examination Under this Import Alert: In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain Salmonella. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.*** 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: *** https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing *** ***Removal from Detention without Physical Examination (ADDITION TO GREEN LIST) In order to remove a firm's product from DWPE, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act and applicable regulations.*** Although FDA may consider five consecutive non-violative commercial shipments over a period of time, analyzed as described in the preceding paragraph, as being adequate for removal from DWPE, we recommend that you also provide documentation with sufficient evidence that future shipments of papaya will not be adulterated. Such documentation could include that the primary production firm has implemented the National Agro-Alimentary Health, Safety and Quality Service (SENASICA) Systems for the Reduction of Contamination Risks (SRRC). For guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)." To facilitate FDA review of your submission, we recommend that you send all documents, except copies of original records, in English. A firm that packs, repacks, or repackages papayas (often referred to as a packinghouse or repacker) 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 washing, packing, and storage operations. If removal from DWPE is determined appropriate for the packer or repacker, 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 shippers, packers and repackers identified on the Green List may be excluded from DWPE if the papayas originate from growers specifically identified in the "Note" section of the firm listing or on the Green List of this Alert.*** If a firm and/or a representative thereof would like to request removal from DWPE by inclusion on the Green List of this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov ***Requests for removal from DWPE will be reviewed by DIO and then referred to HFP for additional evaluation.*** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***

Affected Countries (1)