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Cyclospora Prevention, Response and Research Action Plan

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Cyclosporiasis is a foodborne intestinal illness caused by the parasite Cyclospora cayetanensis (C. cayetanensis). The number of reported cases of cyclosporiasis in the U.S. has been rising in recent years, likely due in part to better diagnostic testing methods. According to the Centers for Disease Control and Prevention (CDC), there have been roughly 6,000 reported domestically-acquired cases of cyclosporiasis over the last 3 years. The number of reported cases typically rises during the spring and summer, from May through August.

Historically cyclosporiasis was associated with travel to or consumption of produce from countries where C. cayetanensis was endemic. In response to outbreaks of cyclosporiasis, FDA has taken samples of imported produce, inspected foreign farms and created import alerts in response to adverse findings. Import Alerts are guidance to FDA’s field staff as well as industry that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA's laws and regulations.

However, over the last several years C. cayetanensis has been increasingly confirmed in surface water and food grown in the US. This may be partially attributed to improvements in testing and surveillance tools that are able to detect this parasite better than in the past.

Using a testing method developed by FDA scientists, C. cayetanensis was first found in domestically grown produce, cilantro, during a 2018 surveillance sampling assignment not associated with an outbreak. Not long after, C. cayetanensis was again detected during an outbreak linked to a salad mix made with ingredients that primarily came from domestic growers.

Rising case numbers and the emergence of C. cayetanensis in domestically grown produce prompted the FDA to create the Cyclospora Task Force in 2019.  The Task Force comprises multidisciplinary experts across FDA and CDC with the goal of reducing the public health burden of foodborne illness caused by C. cayetanensis in produce. The Cyclospora Prevention, Response and Research Action Plan was developed as a strategic guide to achieving this goal through three priority areas:  improving prevention, enhancing response activities, and filling knowledge gaps.

The table below includes actions that support each of the priority areas. In some areas, key accomplishments have already been achieved and are noted in the table. The FDA intends to update the table below as key deliverables are accomplished and as new actions are identified.

Priority Area Action Accomplishments
A. Prevention

A1.Continue to develop and deliver C. cayetanensis education and outreach on prevention measures for growers in collaboration with industry, academia, regulators and other partners.

The FDA intends to continue to build on available educational resources and seeks additional engagement opportunities for farmers working with academia, domestic and international regulatory partners, and industry to provide additional background on C. cayetanensis including its unique characteristics, sources and routes of contamination, and misconceptions. These education and outreach opportunities are intended to help growers understand preventive measures for C. cayetanensis that can be implemented on farms to help prevent contamination of produce.

The FDA developed a fact sheet on C. cayetanensis for farmers

The FDA collaborated with United Fresh and Florida Fruit and vegetable Association (FFVA) to conduct two webinars  in May 2021 and published resources including a technical bulletin.

In June 2020, FDA sent a letter to the FFVA to share concerns about the public health risks associated with C. cayetanensis and offer a Call to Action for produce growers in St. Lucie.

In 2020 the FDA, in collaboration with the Inter-American Institute for Cooperation on Agriculture (IICA), conducted two seminars in Mexico on Cyclospora and produce and agricultural water. One was for the Produce Safety Alliance Produce Safety Rule train the trainers course (in-person) and the second for fresh-herbs growers in Puebla, Mexico (virtual). 

In April 2021, the FDA presented on C. cayetanensis, in both English and Spanish, at a regional webinar hosted by IICA for growers in Latin American and Caribbean countries.  

A. Prevention

A2. Engage with industry, academia, and test kit companies to encourage the modification of available rapid tests kits to specifically detect C. cayetanensis, and to develop industry best practices that can be used to test for C. cayetanensis.

Currently, rapid test kits are not available to specifically detect C. cayetanensis. Developing specific rapid test kits for C. cayetanensis can allow industry to expand testing and conduct root cause analyses to assess for potential sources and routes of contamination if C. cayentanensis is detected in samples.

A. Prevention

A3. Work with industry to research and identify practical ways of controlling C. cayetanensis in the environment and on produce

Typical chemical treatments used on farms are not effective against C. cayetanensis, and therefore, farmers have limited options to control, reduce or eliminate Cyclospora once introduced to the environment. Certain control measures that have been shown to be effective against other parasites could be evaluated for C. cayetanensis. The FDA has been engaging with industry representatives on how best to pursue this research.

B. Response

B1. Expand the capacity of FDA, states, foreign governments, and academia to sample and test for C. cayetanensis

Specifically, the FDA seeks to update and deliver laboratory training to state and foreign governments on FDA C. cayetanensis BAM methods 19b and 19c and on collecting dead-end ultrafiltration (DEUF) samples of agricultural water; utilize the Laboratory Flexible Funding Model (LFFM) to include as an option testing for C. cayetanensis; expand collaboration with universities to conduct surveillance sampling and testing under the Produce Safety Research Consortium (PSRC) managed by the FDA’s Center for Food Safety and Applied Nutrition’s Office of Applied Research and Safety Assessment.

The FDA methods for detection of C. cayetanensis on produce and agricultural water have been shared with and used by domestic and foreign laboratories.

FDA developed training videos on DEUF sample collection procedures for water.

B. Response

B2. Develop and provide training and updates for FDA, state and foreign regulators on Cyclospora

The intent of this training is to help regulators assess farms for risk of contamination from C. cayetanensis, including potential sources and routes of contamination. This information will be particularly useful during outbreak investigations.

The FDA provided technical assistance on the Association of Food and Drug Officials (AFDO) tool for regulators on Cyclospora

FDA presented at the AFDO webinar to state regulators on June 30, 2021.

FDA Office of Regulatory Affairs (ORA) Produce Safety Network (PSN) investigators received training on DEUF sampling throughout 2020.

The FDA conducted training for FDA investigators on Cyclospora in May 2021:

AFDO Cyclospora: Part one – Association of Food and Drug Officials

AFDO Cyclospora: Part two — regulatory approach – Association of Food and Drug Officials

B. Response

B3. Develop a farm investigation questionnaire (FIQ) specific to Cyclospora 

The intent of the FIQ is for use in the investigation of a produce farm implicated in a cyclosporiasis outbreak. The FIQ will be used to document conditions and practices through in-person observations and help guide the produce investigator through the assessment of the environment to determine potential sources and routes of contamination. 

A draft of the C. cayetanensis FIQ has been developed which FDA plans to publish on FDA.gov and share with stakeholders once final.   
B. Response

B4. FDA surveillance sampling of C. cayetanensis in produce.

The FDA plans to continue surveillance sampling of domestic and imported produce to understand trends related to C. cayetanensis contamination, such as seasonality or geography. Sampling also will assist FDA in identifying potential produce vehicles associated with outbreaks.    

FDA is conducting microbiological surveillance sampling of domestic and imported fresh herbs, which includes testing for C. cayetanensis. An analysis of the sampling work will be published on FDA.gov following completion.
B. Response

B5. Continue to engage with the states regarding consistent responsive approaches when C. cayetanensis is detected in the environment or on covered produce. 

Collaborate with the states to promote consistent follow up on C. cayetanensis positive findings, and to continue to communicate the value of the Produce Safety Rule in preventing contamination of covered produce with C. cayetanensis

C. Filling Knowledge Gaps

C1. Evaluate for trends and distribution of cyclosporiasis cases in the US.

The FDA intends to work with CDC to better understand the distribution of cases of cyclosporiasis in the US. For example, we intend to conduct retrospective analyses of past foodborne outbreak investigations as well as analyses of FoodNet case data for trends. This information may help target research on potential sources and routes of transmission.

C. Filling Knowledge Gaps

C2. Advance the development of genotyping methods for C. cayetanensis in clinical, food and environmental samples.

The FDA is working with CDC to advance  genotyping methods (developed by CDC); the MLST/TADS approach will allow us to 1) genetically link cases of illness as one cluster (CDC), 2) genetically link cases to product and/or environmental samples, and 3) genetically link product samples to environmental samples.

C. Filling Knowledge Gaps

C3. Work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to address knowledge gaps related to Cyclospora.

Specifically, the FDA will develop and submit a charge document to NACMCF with the goal of having the multidisciplinary committee lead the development of a report that will improve our understanding of sources and routes of contamination, prevalence, and control measures based on available science.

The FDA developed a charge document related to knowledge gaps of C. cayetanensis which was accepted by NACMCF in early 2021. A committee with representatives from academia, industry, and government is being established to address the work outlined in the charge document and develop a report.
C. Filling Knowledge Gaps

C4. Convene a 2022 Joint Institute for Food Safety and Nutrition (JIFSAN) Research Meeting on Cyclospora

The FDA is working with JIFSAN to hold biannual meetings convening industry, academia, and government officials, both domestically and internationally, to discuss the current state of science related to C. cayetanensis. The purpose of these meeting is to discuss knowledge gaps as well as identify research priorities and opportunities for collaboration. 

The kickoff meeting was held in 2019. FDA planned to reconvene in 2021, however due to COVID-19, this meeting was postponed until 2022.
C. Filling Knowledge Gaps

C5. Collaborate with industry, academia, states, local and foreign partners to promote research to better understand the prevalence of C. cayetanensis in agricultural water.

The FDA plans to work with industry, academia, and states, particularly those that have been implicated in past outbreaks via traceback investigations, as well as Latin American partners to better understand the prevalence of C. cayetanensis in agricultural water in these growing regions.

The FDA participated in a discussion on C. cayetanensis with other produce safety researchers at the Center for Produce Safety Symposium on June 15, 2021.

The FDA is also conducting sampling of surface water for C. cayetanensis at various locations in the US.

C. Filling Knowledge Gaps

C6. Explore the role of wastewater in contributing to C. cayetanensis contamination in produce.

The FDA intends to begin discussions with federal partners to seek collaboration and assistance on FDA’s research priorities to help better understand the role that wastewater and biosolids may have in C. cayetanensis contamination and to explore possible mitigation measures such as treatments.

For example, FDA and CDC are developing a method to detect C. cayetanensis in wastewater. 

C. Filling Knowledge Gaps

C7. Encourage sharing of Cyclospora sampling data

The FDA intends to work with stakeholders to encourage sharing and publication of C. cayetanensis sampling data by industry and other stakeholders. The public sharing of sampling data, such as environmental and/or product samples could help identify trends associated with produce, as well as spur research.


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