June 17, 2021

Mike Joyner, President 

Mike Aerts, Science & Regulatory Affairs

Florida Fruit & Vegetable Association

This letter is being sent with the request that the Florida Fruit & Vegetable Association serve as the 

conduit to the produce growers, harvesters, packers and distributors of the St. Lucie area in delivering 

the message of the public health risk of Cyclospora cayetanensis. 

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention 

(CDC) have noted that the number of reported cases of cyclosporiasis have increased significantly in 

recent years. While this increase may be partially attributed to better diagnostic and detection 

methods, we also know that many cases likely go unreported. Cyclosporiasis is an illness caused by 

the parasite Cyclospora cayetanensis that is most often caused by consumption of contaminated food 

or water. In 2018, 2019, and 2020, CDC reported that there have been respectively 2,299, 2,408, and 

1,241 domestically acquired cases of cyclosporiasis. Outbreaks of cyclosporiasis have been reported 

in the United States since the mid-1990s and have been linked to various types of imported fresh 

produce, including raspberries, basil, snow peas, mesclun, and cilantro. Importantly, 2018 marked the 

first year FDA found the first confirmed evidence of the presence of Cyclospora cayetanensis in 

domestically grown produce. 

In 2020, a multistate outbreak of 701 Cyclospora infections was linked to bagged salad 

mix containing carrots, red cabbage, and iceberg lettuce. FDA investigated multiple farms identified 

in the traceback, and FDA sampled and conducted an investigation around a farm in south Florida. In

response to these events and as part of FDA’s investigation, FDA sampled and found Cyclospora 

cayetanensis in canal water used for irrigation. Following its investigation, FDA was unable to 

conclusively determine the source of this outbreak. FDA continues to work with the state of Florida 

and the local water district to try to determine the source and impact of Cyclospora cayetanensis that 

was found in the regional water management canal (C-23), located west of Port St. Lucie. 

Given the emerging nature of genetic typing methodologies for this parasite in foods and in 

environmental samples, the FDA has been unable to determine if the Cyclospora cayetanensis

detected in the canal can be definitively linked to the clinical cases. However, the presence of 

Cyclospora cayetanensis in a water management canal that had previously supplied water to produce 

farms in the region, and specifically to a farm identified in the traceback, suggests the need for a 

collaborative effort by state, federal and industry partners to better define the scope and sources of 

contamination and identify appropriate risk mitigation measures. 

The detected presence of Cyclospora cayetanensis in the water management canal system may 

constitute a known or reasonably foreseeable hazard that has the potential to serve as a source of 

contamination when growing, harvesting, packing, and holding produce. FDA urges produce 

growers in the St. Lucie produce growing region that use water from the water management canals to 

consider Cyclospora cayetanensis when assessing the risks associated with their operations and take 

risk mitigation measures, where appropriate. 
In an effort to increase awareness 

about the public health risks 

associated with Cyclospora 

cayetanensis and inform produce 

growers, shippers and handlers about 

potential ways to reduce the risk of 

produce contamination with this 

hazard, the FDA, in collaboration 

with the Florida Fruit and Vegetable 

Association and the University of 

Florida Institute of Food and 

Agricultural Sciences, held a virtual 

workshop on May 13, 2021, for all 

interested stakeholders in the St.

Lucie produce growing region. This 

workshop covered the unique aspects 

of Cyclospora cayetanensis

compared to other pathogens and 

provided insights on how it may be 

controlled, reduced, or eliminated. 

Detailed information regarding 

Cyclospora cayetanensis, including 

some requirements for farms covered 

by the Produce Safety Rule may be 

found on the FDA website page 

entitled: Cyclosporiasis and Fresh 

Produce.

FDA has a duty to help 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, in 2015, established

standards for the safe growing, 

harvesting, packing, processing and 

holding of produce sold, imported,

or offered for import in the United 

States, no matter where it is grown.

Industry stakeholders have a

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 

St. Lucie produce industry to review 

their operations and make all 

necessary changes to strengthen 

Call to Action for the St. Lucie area produce industry

Below are a combination of potentially applicable food 

safety requirements and best practices for produce:

• be aware that FDA detected the presence of 

Cyclospora cayetanensis in this water 

management canal system, which may be 

considered a known or reasonably foreseeable 

hazard that has the potential to be a source of 

contamination. 

• assess practices that may lead to Cyclospora 

cayetanensis contamination of produce, so as to 

identify and minimize risks from this and other 

human pathogen(s). Specific consideration should 

be given to evaluating the microbial quality of 

water for the potential presence of Cyclospora 

cayetanensis, especially if water is used in a 

manner where it is intended or likely to directly 

contact covered produce during growing, harvest, 

or post-harvest activities (including water used 

for irrigation, crop protection sprays (e.g., 

pesticides, fungicides), or to move, rinse, and/or 

wax crops).

• use water of adequate quality for its intended use

and follow good agricultural practices to 

minimize hazards and prevent adulteration 

under section 402 of the Federal Food, Drug, and 

Cosmetic Act.

• to evaluate level of risk, consider the use of 

environmental and/or product testing for the 

presence of Cyclospora cayetanensis rather than 

merely relying on visual observations.

• to evaluate if preventive measures for Cyclospora 

cayetanensis are effective, consider the use of product 

testing for the presence of Cyclospora cayetanensis.

• when Cyclospora cayetanensis is identified 

through microbiological surveys, consider preharvest or post-harvest testing of the product or 

the environment, implement root cause analysis, 

working with relevant partners, to determine the 

potential source(s) and route(s) of contamination 

and then implement appropriate prevention and 

verification measures for risk management 

purposes.

• consider collectively funding and actively 

engaging with state officials and academia in 

research (including microbiological surveys) to 

identify the potential sourcesand routes of 

Cyclospora cayetanensis contamination of 

produce and further enhance data-driven, riskbased preventive measures.
public health safeguards against the risk of Cyclospora cayetanensis contaminating fresh produce. 

Working together, we can help prevent these outbreaks.

Rest assured the FDA intends to further strengthen safeguards and prevent produce contaminated 

with Cyclospora cayetanensis from being sold, imported, or offered for import in the U.S. We 

conduct compliance and enforcement activities, as appropriate, and are actively engaging in 

education, outreach, training, and research activities designed to support growers’ efforts to keep their 

food safe for consumers.

However, we can’t do this alone and believe that more must be done by industry to further safeguard

public health. We look forward to working with you to reach our shared goal of helping to ensure a 

safe food supply for consumers.

Sincerely,

Mark Moorman, Ph.D. 

Director, Office of Food Safety 

Center for Food Safety & Applied Nutrition 

 

CC:

Produce Marketing Association

United Fresh Produce Association

Food Industry Association

Associated Wholesale Grocers

International Foodservice Distributors Association

National Grocers Association

National Restaurant Association

Consumer Brands Association

National Customs Brokers and Forwarders Association