U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

w ww.fda.gov

August 26, 2019

Dear Papaya Growers, Harvesters, Packers, Distributors, Exporters, Importers, and Retailers:

As we write this letter, the U.S. Food and Drug Administration (FDA or the agency) and other 

public health agencies are investigating an outbreak of Salmonella Uganda infections tied to the 

consumption of whole, fresh papaya. As of this date, more than 70 people in eight states have 

gotten sick, according to the Centers for Disease Control and Prevention.

Since 2011, FDA has noted a pattern of recurrent outbreaks tied to consumption of imported 

papayas from Mexico. Because of these outbreaks, hundreds of people have fallen ill and two 

have died. FDA is greatly concerned about recurring outbreaks.

As Mexico is the largest supplier of papaya to U.S. consumers, we are actively engaged with our 

regulatory counterparts in the Mexican government in investigating this current outbreak and are 

working together to prevent any future outbreaks related to contaminated papaya.

FDA has a duty to protect consumers from contaminated food, a commitment at the heart of our 

public health mission and one that we take very seriously. In pursuit of this goal, FDA sets 

standards for the safe growing, harvesting, packing, processing and holding of produce sold in 

the United States, including papaya, no matter where in the world it is grown.

Industry stakeholders have the primary responsibility to ensure that foods they bring to market 

are safe for consumers to eat and serve their families. We urge all segments of the papaya 

industry to review their operations and make all necessary changes to strengthen public health 

safeguards. 

Working together, we must end these outbreaks. 

Safety Is an Ongoing Concern

FDA is aware of eight outbreaks since 2011 caused by Salmonella serotypes that have been tied 

to consumption of imported fresh papaya. While the 2019 outbreak is ongoing, the first seven 

outbreaks account for almost 500 reported cases of illness, more than 100 hospitalizations and 

two deaths. The pattern of recurrent outbreaks we have observed since 2011, including the 2019 

illnesses, have involved Salmonella infections traced back to or suspected of being associated 

with papaya growing operations in Mexico. (For a breakdown of outbreaks and illnesses, see the 

chart at the end of this letter.) 

Fresh papayas are most often eaten raw, without undergoing a process to eliminate potential 

microbial hazards. Therefore, the way they are grown, harvested, packed, held, processed and 

distributed is crucial to minimizing the risk of contamination with human pathogens. 
Page 2 – PAPAYA

In response to this most recent Salmonella Uganda outbreak, FDA deployed an inspection team 

to the packing house and farm that supplied papayas linked to people who got sick. The findings 

of those visits will be made public when FDA’s investigation is complete, consistent with our 

regular procedures. To further our prevention efforts, FDA is collaborating with our counterparts 

in the Mexican government regarding this current outbreak through the agency’s Latin America 

Office.

Regulatory Requirements and Industry Responsibility

The recurring nature of these outbreaks is a clear indication that more must be done within the 

papaya industry to protect its customers and to meet legal obligations. 

The U.S. Federal Food, Drug and Cosmetic Act prohibits food producers from introducing, or 

delivering for introduction, into interstate commerce adulterated foods that are potentially 

harmful to consumers.

Additionally, there are new requirements under the FDA Food Safety Modernization Act 

(FSMA). The Produce Safety Rule1 (under FSMA sets science and risk-based minimum 

standards for domestic and foreign farms for the safe growing, harvesting, packing and holding 

of covered produce, which includes papaya. Unless not covered due to farm size or eligible for 

an exemption due to other factors, all growers of covered produce, including papaya growers in 

Mexico and other nations, are covered by the rule. 

Another FSMA rule, the Foreign Supplier Verification Program2

, makes importers responsible 

for verifying that the foods they bring into the United States, including papaya, have been 

produced in a manner that meets applicable U.S. safety standards (e.g. the Produce Safety Rule). 

Call to Action

To meet food safety requirements and follow best practices to provide the public with safe foods, 

we are asking the papaya industry to:

• assess the factors that make crops vulnerable to contamination. If a foodborne pathogen 

is identified in the crop or growing environment, a root cause analysis should be 

performed to determine the likely source of contamination. Procedures and practices that 

minimize that risk must be implemented.

• examine the use and monitoring of water used to grow, spray (pesticides, fungicides), 

move, rinse or wax crops to identify and minimize risks from potential hazards.

• adopt tools and practices needed to enhance traceability. Papayas are a perishable 

commodity, and traceability information should facilitate the rapid tracking of involved 

product to expedite its removal from commerce, prevent additional consumer exposures, 

and properly focus any recall actions.

• fund and actively engage in food safety research to identify the potential sources and 

 1 https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety 2 https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verificationprograms-fsvp-importers-food-humans-and-animals
Page 3 – PAPAYA

routes of microbial pathogens and develop data-driven and risk-based preventive 

controls.

We recognize that we are in this together. Rest assured that the FDA intends to use all the tools 

and enforcement powers we have available to further strengthen safeguards and prevent 

contaminated papayas from being imported into the U.S. Those tools include education, 

outreach, training, enforcement, and research activities designed to support farmers’ efforts to 

keep their crops safe for consumers.

However, we can’t do this alone and believe that more must be done by industry as repeated 

outbreaks are unacceptable from a public health perspective. We look forward to working with 

you to reach our shared goal of ensuring a safe food supply for consumers. 

Sincerely,

Frank Yiannas Melinda K. Plaisier

Deputy Commissioner for Food Policy Associate Commissioner

and Response for Regulatory Affairs

CC: 

ProPapaya, the National Papaya Board of Mexico

Fresh Produce Association of the Americas

Texas International Produce Association

Produce Marketing Association 

United Fresh Produce Association

Food Marketing Institute

Associated Wholesale Grocers

International Foodservice Distributors Association

National Grocers Association

National Restaurant Association

Grocery Manufacturers Association

Florida Fruit & Vegetable Growers Association

California Fresh Fruit Association

Western Growers

American Association of Exporters and Importers

Express Association of America

National Customs Brokers and Forwarders Association 
Page 4 – PAPAYA

Foodborne Illness Outbreaks Tied to Papayas

Foodborne illness outbreaks of Salmonellosis by serotype, associated with whole, fresh papayas 

as the confirmed or suspected food vehicle. 

Outbreak Year Salmonella

serotype(s)

Confirmed 

Cases

Hospitalizations Deaths 

attributable to 

Salmonella

1 2011 Agona 99 0 0

2 2012 Agona

suspected

25 5 0

3 2017 Anatum 20 5 1

4 2017 Braenderup

suspected

55 18 0

5 2017 Outbreak #5 

Serotypes: 

Thompson, 

Kiambu, Agona, 

Gaminara, 

Senftenberg

213 68 1

6 2017 Urbana 7 4 0

7 2017 Newport & 

Infantis

4 2 0

8 2019 Uganda 71 27 0

Total 494 129 2