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STEER CLEAR OF THESE DIRTY PAPAYAS

FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas

November 4, 2017

Fast Facts

•The FDA advised consumers not to eat Maradol papayas from the following farms in Mexico because they were linked to outbreaks of salmonellosis: ◦Carica de Campeche in Tenabo, Campeche, MX

◦Rancho El Ganadero in Colima, MX

◦El Zapotanito in La Huerta, Jalisco, MX

◦Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, MX

•Increased testing by the FDA identified papayas from three additional farms that were positive for Salmonella strains that matched illnesses not related to this outbreak.

•Four brands of Maradol papayas were recalled. If anyone has these papayas in their home, they should dispose of them immediately: ◦Caribeña brand, distributed by Grande Produce;

◦certain Cavi brand papayas distributed by Agroson’s;

◦Valery brand papayas, distributed by Freshtex Produce, LLC;

◦Frutas Selectas brand papayas, distributed by Bravo Produce.

•The FDA added firms whose papayas test positive for outbreak strains to Import Alert (IA) 99-35.

•CDC reports a total of 251 people were infected with the outbreak strains of Salmonella Thompson (144), Kiambu (54), Anatum (20), Agona (12), Gaminara (7), Urbana (7), Newport & Infantis (4), and Senftenberg (3), from 25 states. Seventy-nine ill people were hospitalized. Two deaths were reported, one from New York City and one in California.

•The FDA began investigating the Salmonella Anatum outbreak on March 17, 2017. CDC reports 20 cases in 3 states with 5 hospitalizations and 1 death.

What was the Problem and What was Done About It?

The FDA, CDC, and several states and local officials are investigating Salmonella illnesses from a variety of serotypes linked to papayas from Mexico. These serotypes include: Kiambu, Thompson, Agona, Gaminara, Anatum, Newport, Infantis and Urbana.

Four brands of Maradol papayas have been recalled:

•Caribeña brand, distributed between July 10 and 19. The Caribeña brand can be identified by a red, green, and yellow sticker.

•Cavi brand, distributed to wholesalers in New York, Connecticut, and New Jersey from July 16-19 and available to consumers until July 31.The Cavi brand carries a purple, green, and black sticker with the words “cavi MEXICO 4395” in white. Only certain lot codes of Cavi papayas were recalled that were known to come from Carica de Campeche. Boxes provided to wholesalers are stamped with CARICA DE CAMPECHE on the upper left side of the box. Other Cavi papayas, sourced from other farms, are not being recalled.

•Valery brand, distributed from July 10-13. Valery Maradol papayas have a red, yellow, and green sticker with “Valery” in yellow letters.

•Frutas Selectas brand, distributed to markets in the state of California between August 10 and 29. Frutas Selectas papayas have a red, yellow, and green sticker with Frutas Selectas De Tijuana written in yellow letters on the green part of the sticker.

Consumers who have any of these papayas in their homes should not consume them and throw them away.

The FDA and state partners investigated the distribution of the papayas involved in the outbreaks to ensure that there were no other brand(s) that these papayas may have been sold under.

The four firms that issued the above recalls, Grande Produce, FreshTex, Agroson’s, and Bravo Produce, cooperated fully with the FDA in issuing the recalls following notification of the information gathered by the FDA and CDC.

Bravo Produce, the importer of Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, MX, notified its customers about the recall and asked them to remove and destroy the papayas that are on store shelves and other commercial places. The FDA will be performing audit checks to help ensure product has been removed from the marketplace.

Papayas from the Carica de Campeche farm tested positive for Salmonella Kiambu, Salmonella Thompson, Salmonella Agona, Salmonella Senftenberg, and Salmonella Gaminara. CDC announced it added Salmonella Kiambu, Salmonella Thompson, Salmonella Agona Salmonella Gaminara, and Salmonella Senftenberg infections to this outbreak investigation based on epidemiological and laboratory evidence. Whole genome sequencing (WGS) is available for most clinical isolates and supports the relationships to papaya isolates identified by PFGE. The Carica de Campeche farm has been added to Import Alert (IA) 99-35.

The FDA increased testing of papayas from Mexico in an effort to see if fruit from other farms or distributors could be contaminated.

Since 2011, papayas from Mexico have been screened at the border for Salmonella by third-party laboratories, and these shipments have not been allowed to enter the country without documentation of testing demonstrating the products tested negative for Salmonella. Farms/companies have been able to request addition onto the “green” list of IA 21-17 when they have had five consecutive shipments test negative for Salmonella. In contrast, farms/companies that want to request removal from the “red” list of IA 99-35 must present substantive documentation demonstrating that they have made corrections to prevent contamination, including, for example, a root cause analysis to identify potential sources and routes of contamination.

FDA’s testing of papayas at the border revealed three additional positive import samples that linked to sick individuals.

Samples of papayas from Caraveo Produce in Tecomán, Mexico were determined to be positive with Salmonella Infantis and Newport. The shipment that tested positive was not released into US commerce; however, these Salmonella strains have at least one PFGE match to a sick person. Additionally, WGS showed clinical isolates were highly genetically related to isolates from samples from the papaya shipment received from Caraveo Produce of Mexico. This indicated that papayas from previous shipment(s) imported by Caraveo Produce were the likely cause of those related illnesses. Evidence obtained by the FDA indicated there were no shipments imported by Caraveo Produce on the market because they were all past shelf life. Caraveo Produce identified Rancho El Ganadero in Colima, MX as the supplier of papaya for these shipments.

Papayas from El Zapotanito in La Huerta, Mexico were determined to be positive with Salmonella Urbana. The shipment that was positive was not released into commerce; however, the PFGE pattern from this sample was found in recent clinical isolates from seven ill people. Three of five people interviewed reported eating papayas before they became ill. This indicated that papayas from previous shipment(s) from El Zapotanito were the likely cause of these related illnesses. Evidence obtained by the FDA indicated that there were likely no shipments from El Zapotanito on the market because they were all past shelf life. The FDA placed El Zapotanito on IA 99-35, and investigated whether other importers may have sourced papayas from El Zapotanito.

Papayas from Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, MX were determined to be positive with Salmonella Anatum. Whole genome sequencing confirmed that the strain of Salmonella isolated from the papayas matched the genetic fingerprint for 20 cases of illness. The Maradol Papayas were available for sale until August 29, 2017. The FDA worked with the importer, Bravo Produce of San Ysidro, CA, to ensure all product was removed from the marketplace. The FDA placed Productores Y Exportadores De Carica Papaya De Tecomán y Costa Alegre on IA 99-35.

The FDA maintained close communication with Mexican food safety authorities, Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA) and Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), on the outbreak investigations and the FDA’s regulatory activities on implicated Mexican firms. Mexican food safety authorities conducted inspections and other follow up activities at firms of interest.

CDC reports a total of 251 people were infected with the outbreak strains of Salmonella Thompson (144), Kiambu (54), Anatum (20), Agona (12), Gaminara (7), Urbana (7), Newport & Infantis (4), and Senftenberg (3), from 25 states. Seventy-nine ill people were hospitalized. Two deaths were reported, one from New York City and one in California.

The FDA began investigating the Salmonella Anatum outbreak on March 17, 2017. CDC reports 20 cases in 3 states with 5 hospitalizations and 1 death.

Timeline

On June 26, 2017, the CDC notified the FDA about a Salmonella Kiambu cluster detected by PulseNet. All 47 cases have the same pattern by pulsed-field gel electrophoresis (PFGE). Whole Genome Sequencing (WGS) analysis was conducted on ten patient samples in the outbreak cluster and all were highly related. This indicates that the patients were likely sickened by the same type of food.

MDH informed the FDA, CDC, and state partners that several ill people shopped at the same Baltimore retail location and purchased papayas. Records and samples of green and yellow papayas were collected. On July 17, 2017, Maryland reported that three of ten samples had preliminarily tested positive for Salmonella. All positive samples were Caribeña brand yellow Maradol papayas from Mexico; none of the green papayas were positive. Further WGS testing linked one of the papaya samples to the Salmonella Kiambu outbreak and another to Salmonella Thompson. However, Maradol papayas are green before they ripen and turn yellow, so consumers should not eat Caribeña brand papayas regardless of the color.

On July 19, 2017, MDH issued an advisory warning consumers not to eat Caribeña brand yellow Maradol papayas. Further WGS testing linked one of the papaya samples to the Salmonella Kiambu outbreak and another to Salmonella Thompson.

On July 26, 2017, Grande Produce issued a press release to notify consumers that it had conducted a limited recall of Caribeña brand Maradol papayas distributed during the dates of July 10 to July 19, 2017.

On July 27, 2017, the FDA issued an outbreak posting advising consumers to avoid all Caribeña brand Maradol papayas, regardless of color or date of distribution.

On August 3, 2017, following extensive traceback and testing, the FDA added papaya farm Carica de Campeche to Import Alert (IA) 99-35. Papayas from the Carica de Campeche farm tested positive for Salmonella Kiambu, Salmonella Thompson, Salmonella Agona, Salmonella Senftenberg, and Salmonella Gaminara.

On August 4, 2017, Agroson’s, LLC, issued a press release announcing the recall of certain Cavi brand Maradol papayas. Agroson’s states that the papayas were distributed on July 16-19, and available to consumers until July 31.

Also on August 4, 2017, CDC announced it is adding Salmonella Thompson illness to this outbreak investigation because of epidemiological evidence. Also, FDA and Maryland state testing has indicated that both serotypes of Salmonella were present in a single fruit.

On August 7, 2017, Freshtex Produce, LLC, issued a press release announcing the recall of Valery brand Maradol papayas that were distributed in the state of Illinois from July 10-13. These papayas may have been further distributed outside of Illinois.

Also on August 18, 2017, CDC announced it is adding Salmonella Agona and Salmonella Gaminara illness to this outbreak investigation because of epidemiological evidence.

On September 10, 2017, the FDA and CDC announced increased case counts. In addition, FDA announced that papayas from Rancho El Ganadero in Colima, MX, distributed by Caraveo Produce of Tecomán, MX, and El Zapotanito in La Huerta, MX tested positive for Salmonella strains that matched illnesses not related to this outbreak. To the FDA’s knowledge, there are no papayas from these farms currently on the market, but the agency is continuing traceback and trace forward activities.

On August 24, 2017, the FDA confirmed that papayas collected on August 10, 2017, from an import shipment of papayas originating from Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, MX had tested positive for Salmonella Anatum. On September 4, 2017, WGS (whole genome sequencing) confirmed that the strain of Salmonella Anatum isolated from the positive import sample matched the genetic fingerprint for 14 cases of illness, including 5 hospitalizations and one death. On September 9, 2017, Bravo Produce Inc. issued a press release announcing the recall of boxes of papayas from Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, MX. Bravo Produce states that the papayas were distributed in the state of California between August 10 and 29 and available to consumers until August 29.

On September 11, 2017, the FDA advised consumers not to eat Maradol papayas from Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre Tijuana, Baja California MX. Increased import screening by the FDA found Salmonella Anatum in these papayas that was closely related genetically in 14 cases of illness.

On November 3, 2017, the CDC closed the formal investigation and FDA continues to screen papayas and enforce the standards under IA 99-35.

What are the Symptoms of Salmonella Infection?

Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.

How Soon After Exposure do Symptoms Appear?

Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.

What are the Complications of Salmonella Infections?

In some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

Who is at Risk?

Children are the most likely to get salmonellosis. Children younger than five, the elderly, and those people with weakened immune systems are more likely to have severe infections.

What Do Restaurants and Retailers Need To Do?

Restaurants and retailers should ask whether their distributors receive product from Carica de Campeche in Campeche, Mexico, Rancho El Ganadero in Colima, Mexico, El Zapotanito in La Huerta, Mexico and Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre, Tijuana, Baja California, Mexico.

If so, restaurants and retailers should not purchase those products and throw away any such products they have in their establishments.

Retailers, restaurants, and other food service operators who have served any potentially contaminated papayas need to be concerned about cross contamination of cutting surfaces and utensils. They should follow the steps below:

•Wash and sanitize display cases and refrigerators where potentially contaminated products were stored.

•Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products.

•Wash hands with hot water and soap following the cleaning and sanitation process.

•Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination.

•Avoid cross contamination through contact with crates or other containers where potentially contaminated products were held or shipped. Wash and sanitize such containers as appropriate.

What Do Consumers Need To Do?

Consumers should ask restaurants and retailers whether they use Caribeña, Valery or Cavi brands of Maradol papayas and/or whether their distributors receive product from Carica de Campeche in Mexico, Rancho El Ganadero in Colima, Mexico, and El Zapotanito in La Huerta, Mexico and Productores Y Exportadores de Carica Papaya in Tecomán, Costa Alegre Mexico. If so, consumers should not consume or purchase those products and throw away any such products they have in their home. Brands of papayas can be supplied by multiple farms. Consumers who are not sure of the origin of their papayas should avoid them: when in doubt, throw it out.

For refrigerators and other food preparation surfaces and food cutting utensils that may have come in contact with potentially contaminated papayas, it is very important that the consumers thoroughly clean and sanitize these areas and items.

Consumers should follow these simple steps:

•Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; dry with a clean cloth or new paper towel.

•Wash hands with warm water and soap for at least 20 seconds before and after handling food.

•Wipe up spills in the refrigerator immediately and clean the refrigerator regularly.

•Always wash hands with warm water and soap following the cleaning and sanitization process.

Who Should be Contacted?

If you think you might have become ill from eating potentially contaminated papayas, talk to your health care provider. Contact your health care provider if you have diarrhea that lasts for more than 3 days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine. The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern Time, or to consult the fda.gov website: http://www.fda.gov.

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