Cyclospora Prevention, Response and Research Action Plan

0
Source: FDA · May 15, 2022 · Active · Official government notice

Cyclospora is a microscopic parasite that can cause intestinal illness in humans when consumed through contaminated food or water. While cyclosporiasis can be acquired when people eat food or drink water contaminated with Cyclospora during travel outside the U.S., most of the domestically-acquired (non-travel related) cyclosporiasis outbreaks in the U.S. have been primarily linked to imported fresh produce such as raspberries, cabbage, basil, cilantro, parsley, broccoli, snow peas, sugar snap peas, lettuce and other leafy greens. The Cyclospora parasite requires warm, humid conditions to mature into its infectious form. Each year, the U.S. typically sees several thousands of cases of cyclosporiasis typically during the summer season from May through August. FDA addresses this seasonal outbreak trend by employing a number of activities throughout the year to both prevent and respond to cyclosporiasis cases. 

These include, but are not limited to:

  • Increased import screening of produce from areas where Cyclospora is endemic when a signal is detected. 
  • FDA and state personnel use a specific Cyclospora questionnaire during Cyclospora outbreak investigations to identify sources and routes of contamination. 
  • Continuous engagement with international stakeholders, including Mexico and Colombia. The FDA-SENASICA-COFEPRIS Food Safety Partnership provides a framework for improved communication and coordination of responses to foodborne illness outbreaks with the Mexican government, as cooperation on sampling and testing, including most recently, on Cyclospora investigations, as well as coordination of efforts to prevent future outbreaks.

Still, FDA recognizes that more work needs to be done on prevention and mitigation strategies to reduce cases of cyclosporiasis in the U.S. Therefore, FDA, along with experts from CDC, established the Cyclospora Task Force in 2019. The task force is comprised of multidisciplinary experts across FDA and CDC with the goal of reducing the public health burden of foodborne illness caused by Cyclospora in produce. In 2021, the task force released the Cyclospora Prevention, Response and Research Action Plan (Action Plan) as a multi-year strategic guide toward achieving this goal through three priority areas: 

  • improving prevention, 
  • enhancing response activities, and 
  • filling knowledge gaps. 

The Action Plan has continued to evolve over the years as more information is learned about this parasite. Below is the 2026 update which details strategies, accomplishments, and FDA’s plan for future action.

**Note** FDA and CDC are continuing to evaluate the 2026 Cyclospora outbreak season, including the investigation into the multi-state outbreak linked to iceberg lettuce. Additional information and actions will be incorporated into this plan as that evaluation is completed.

 

  • Continue to develop education and outreach on prevention measures for growers in collaboration with industry, academia, regulators and other partners
    • From April 2021 to May 16, 2022, FDA delivered a total of 9 webinars in collaboration with regional stakeholders. These webinars were designed to educate farmers and stakeholders on Cyclospora, including background, basic information, risk assessment and preventive measures. These webinars will continue to be updated and conducted, including with U.S. and international partners as well as industry groups. 
  • Encourage the development and use of rapid test kits for industry 
  • Advance Root Cause Analysis strategies including leveraging Artificial Intelligence via FDA’s Strengthening Food Safety through Root Cause Analysis initiative 
  • Foster dialogue among FDA, Cyclospora experts, industry, international partners and others.
    • Between November 2022 and May 2026, experts from U.S. (including epidemiologists from state public health departments), Canada, Italy, United Kingdom, and Colombia, presented novel data on Cyclospora research through 40 webinars organized by the FDA Cyclospora Task Force. This activity is providing essential information to refine the FDA plans to advance Cyclospora food safety research. 
    • Since November 2022, FDA has held monthly meetings with domestic and international Cyclospora experts to report on food safety research and emerging science.
    • FDA continues to engage with produce industry stakeholders, by participating in outreach activities, such as the one hosted by the International Fresh Produce Association (IFPA).
    • The Joint Institute for Food Safety and Nutrition (JIFSAN) held a meeting in 2019 to bring together industry, academia and government, both domestic and international, to discuss the current state of science related to Cyclospora identify knowledge gaps and research priorities and opportunities for collaboration.  
  • Continue to strengthen international partnerships and engagements
    • Continue engagement with produce stakeholders in Mexico
      • FDA continues to strengthen engagement with Mexico through the FDA-SENASICA-COFEPRIS Food Safety Partnership (FSP)
        • Under the FSP, FDA along with Mexico, have established a Binational Protocol Notification (BNP) that either country can activate and provides a standard for how the two countries can work together during outbreaks. 
        • FDA has identified outbreak trends linking implicated produce to the Mexican states of Puebla and Tlaxcala and has launched a comprehensive engagement initiative with Mexican produce stakeholders to strategically address this food safety challenge.
          • As part of this work in May 2026, FDA hosted a Cyclospora Symposium in Puebla, MX with four overarching objectives:
            • advancing food safety standards for imported fresh herbs,
            • fostering sustainable public-private partnerships,
            • promoting industry accountability, and 
            • empowering agricultural workers through targeted training.
          • The May 2026 symposium featured lectures and expert panel discussions with speakers from FDA, SENASICA, COFEPRIS, SADER, and the University of Puebla, drawing an audience of more than 230 attendees. Complementing the symposium, FDA collaborated with SENASICA, COFEPRIS, and local growers to conduct educational farm visits aimed at identifying operational gaps in farm practices that could lead to contamination of produce with Cyclospora. As part of the FSP, we will continue to engage with Mexico to advance Cyclospora education and outreach and are looking at next steps following the symposium. 
        • The FSP has identified addressing recurring outbreaks of cyclosporiasis as a priority. FDA is interested in additional engagement with Mexican stakeholders to support improved industry best practices, continuous education and outreach, and verification activities.
    • Continue engagement with produce stakeholders in Colombia
      • FDA surveillance and for-cause sampling has identified Cyclospora in basil imported from Colombia, raising public health concern. FDA has worked with stakeholders in Colombia to increase awareness and prevention efforts around Cyclospora. Colombia has been able to bring leading Cyclospora experts to the conversation. As part of FDA’s broader engagement with Colombian produce stakeholders, FDA developed a targeted webinar series delivered entirely in Spanish to maximize accessibility and reach.
        • To date, two webinars have been conducted in collaboration with our Colombian partners – ICA (Colombian Institute of Agriculture), INS (National Institute of Health), and AGROSAVIA (Colombian Corporation for Agricultural Research) between September 2025 and April 2026, covering the global public health impact of Cyclospora and the testing methodologies available for produce and environmental samples. Below is the recording of the second webinar, available on YouTube:
        • A third webinar, focused on evidence-based strategies to prevent produce contamination with Cyclospora, is planned for later in 2026.
  • Continue to enhance partnerships with state regulators to detect and respond to Cyclospora contamination 
  • Enhance consumer messaging regarding food safety during the Cyclospora season
    • In July 2026, the FDA updated Cyclospora | FDA to provide additional clarifying information for consumers. 
  • Strengthening compliance with the Foreign Supplier Verification Program (FSVP) 
    • FDA is utilizing authority under FSVP to ensure U.S. importers verify that their foreign suppliers use at least the same standards to mitigate contamination from Cyclospora as those required by domestic growers, such as required by the Produce Safety Rule and processors as required by Preventive Controls For Human Foods. FDA also prevents importation of food from importers who are found not to comply with FSVP, utilizing the Import Alert process.
  • Issuing Guidance for Industry on Minimizing Biological Hazards in Ready-To-Eat Fresh Produce
  • Continue to strengthen response activities with foreign regulatory authorities
    • Response coordination has been enhanced under the FSP with Mexico:
      • In 2025, FDA investigated two Cyclospora outbreaks in the United States linked to cilantro and parsley traced from Puebla and Tlaxcala, Mexico. The binational outbreak protocol was activated, and information was shared with Mexican counterparts. As part of these response efforts, FDA conducted joint unannounced inspections alongside SENASICA and COFEPRIS of firms in Mexico. 
      • In 2025, FDA technicians used Mexican laboratories to process FDA samples to support outbreak investigation efforts. 
      • In response to 2026 outbreaks of cyclosporiasis, FDA initiated the binational outbreak protocol – initiating information sharing and coordination with SENASICA and COFEPRIS on response activities.
  • Expand surveillance activities and capacity in collaboration with state and foreign public health partners
    • Surveillance activities:
      • Between January and June 2026, six state laboratories began routine surveillance of bagged leafy greens and packaged herbs for Cyclospora through the Laboratory Flexible Funding Model (LFFM). These samples analyzed 58 samples of package herbs and 109 samples of bagged leafy greens; all samples were negative.  
      • In 2024-2025, the LFFM supported five state laboratories to onboard the updated BAM Chapter 19b Mit1C PCR Method, and seven state laboratories to implement the Cyclospora DEUF Agricultural Water method (located in Other Analytical Methods of Interest to the Foods Program).
      • In 2021, FDA completed surveillance sampling assignment of domestic and imported fresh herbs, which includes testing for Cyclospora. The results and conclusions obtained from this assignment were published in 2024 (FDA Releases Summary Report on Fresh Herbs Sampling Assignment | FDA)
    • Advancing laboratory capacity:
      • FDA has posted its recommended methods for detecting Cyclospora in fresh produce and agricultural water. The fresh produce method is available in the BAM, chapter 19b. The current agricultural water method FDA is using is available in Other FDA Microbiological Methods of Interest. 
      • FDA has worked with partners to expand capacity at the state level to test for Cyclospora
        • FDA has utilized the LFFM to expand Cyclospora testing among state partners, with 7 states currently having the ability to conduct Cyclospora testing. 
      • FDA developed training videos on DEUF sample collection procedures for water.
      • FDA has also worked with a number of international partners to provide training and expand capacity for Cyclospora testing. 
        • In 2025, FDA, in collaboration with the Maryland Department of Health, trained laboratory personnel from Guatemala and Mexico on methods for detecting Cyclospora in produce.
        • Through the Food Safety Partnership with Mexico, FDA conducted in person training to expand Mexico’s laboratory capacity in SENASICA and COFEPRIS to test for Cyclospora in fresh produce in 2023.
  • Expand rapid response capacity to respond to Cyclospora outbreaks
    • In 2026, FDA virtually trained more than 20 FERN (Food Emergency Response Network) laboratories on the BAM chapter 19b method through a series of webinars.   
    • In 2023, FDA presented at the Rapid Response Team (RRT) conference on Cyclospora outbreaks, detection and response activities. FDA provides multi-year cooperative agreements to states to form and maintain RRTs which are multi-agency, multi-disciplinary teams that respond to food emergencies.
    • In 2022, FDA provided training on DEUF water sampling to RRT state regulatory partners.
  • Continue to advance development and use of genotyping methods for Cyclospora 
    • FDA has worked with CDC to develop and refine genotyping tools. The FDA developed a new targeted amplicon sequencing genotyping assay for Cyclospora that expands the number of genetic targets for distinguishing among samples and also allows genotyping of food samples with low contamination levels. 
    • FDA and CDC demonstrated the increased genetic resolution of that method and the ability to genetically link food and clinical samples Evaluation of the Increased Genetic Resolution and Utility for Source Tracking of a Recently Developed Method for Genotyping Cyclospora cayetanensis – PubMed
    • In addition, the genetic targets were updated in collaboration with CDC.
    • In 2024, FDA and CDC began building a genotype database which now includes 348 genetically, geographically, and epidemiologically diverse specimens. As new clinical samples are added to the database, information about how closely they are related genetically to those from past illnesses and outbreaks can be obtained. This will help the FDA during outbreak investigations. 
    • FDA and CDC are working to harmonize the method for clinical, food, and environmental samples.
  • Enhance FDA’s Cyclospora investigation protocols
    • FDA developed and deployed use of a Farm Investigation Questionnaire (cFIQ) that is used by investigators during outbreak investigations and sampling assignments. The cFIQ (Cyclospora-specific FIQ) includes unique questions specific to Cyclospora and Cyclospora-related environmental conditions that an investigator can use during inspections and investigations to determine potential sources and routes of Cyclospora contamination and supports consistency of Cyclospora-related investigations.
  • Collaborate with CDC to evaluate trends and better understand the prevalence of cyclosporiasis in the United States
    • In 2025, FDA researchers published a peer-reviewed study evaluating the epidemiological characteristics of U.S. foodborne cyclosporiasis cases and outbreaks from 2015 to 2019 using Foodborne Diseases Active Surveillance Network (FoodNet) and Foodborne Disease Outbreak Surveillance System (FDOSS) data. Key findings included a strong summer seasonality (90.9% of cases), predominance of domestic rather than travel-associated transmission, and that 71.7% of FoodNet cases were outbreak-associated. 
  • Collaborate with industry, academia, states, and foreign partners to better understand the prevalence of Cyclospora in fresh produce and agricultural water
    • FDA has established a partnership with EPA, Texas Department of State Health Services, Baylor University, and other city collaborators to collect wastewater treatment facility samples to develop and validate a method for the detection of Cyclospora in raw and treated wastewater. Treated wastewater may be commingled with other surface waters after discharge, that are used for agricultural purposes. This work will provide a better understanding of how Cyclospora contaminated water may be used in agriculture. 
  • Work with industry to advance Cyclospora data-sharing strategies
    • Between 2023 and 2024, FDA Cyclospora Task Force members held multiple meetings with produce industry stakeholders at FDA’s Human Foods Program (HFP) headquarters. Discussions focused on the analysis and review of data accumulated by industry over previous years, including environmental sampling data aimed at better understanding prevalence and distribution of Cyclospora in agricultural environments. These meetings also included discussions about how to control for and minimize produce contamination by Cyclospora while emphasizing One Health frameworks that look to the intersection of human and environmental health and its impact on produce safety.  
  • Advance research into practical ways of controlling Cyclospora in the environment and on fresh produce
  • Develop a repository of Cyclospora oocysts for use in research 
    • FDA has made significant progress in working with international and domestic partners to develop a repository of Cyclospora oocysts from biological samples which will support food safety research and operational scientific and laboratory functions
  • Advance studies toward in vitro propagation, viability, and infectivity of Cyclospora
    • FDA has provided technical assistance for a project funded by CPS. 
    • FDA to explore studies to better understand how consumers and processors can reduce risks associated with Cyclospora 
    • FDA has initiated a number of studies in the in vitro propagation of the parasite including:
      • Evaluation of the Use of a Gut-on-a-Chip System for in vitro Propagation of Cyclospora cayetanensis 
      • Evaluation of the New Approach Methodologies (NAMs) for Propagation of Cyclospora cayetanensis

Contact Us

Questions can be sent to CyclosporaActionPlan@fda.hhs.gov. 

Additional Information


View Official FDA Notice
Related Story