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 recently updated a fact sheet on C. cayetanensis for farmers.

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

From April 2021 to May 16th 2022, FDA delivered a total of 8 Webinars in collaboration with regional stakeholders. These webinars were designed to educate farmers and stakeholders on C. cayetanensis, including background, basic information, risk assessment and preventive measures.

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.

The FDA has provided technical assistance to test companies that are exploring the feasibility of development of C. cayetanensis test kits. 

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.

The FDA has provided technical input into various projects funded by the Center for Produce Safety.

• Determination of physical and chemical mechanisms to prevent Cyclospora infection
• AFECCT: Assessing filtration efficacy for Cyclospora control

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. Currently, the FDA is making minor modifications to the methods, which will be published when they are final. These updates will not require new training by ORA and state laboratories.

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

We have established a collaboration with The Northeast Center to Advance Food Safety as part of the Produce Safety Research Consortium where we are planning to collect water samples to test for the presence of the parasite to establish a baseline understanding of its prevalence in agricultural water sources.

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 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 2020:

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

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

The FDA provided a presentation at APHL Conference on May 18, 2022 on the detection of the pathogen on produce and water on the session Parasites: A Cause for Concern as an Emerging Food Safety Threat.

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. 

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.    

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. 

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.

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.

Currently, the FDA is exploring several options to identify the diversity of the organism and to potentially link outbreaks based on such diversity. This includes the implementation of a genotyping approach for C. cayetanensis in environmental and food samples based on the same method published by CDC. This methodology is the only one available for genetic typing characterization of C. cayetanensis.  These genotyping tools will be available for the first time to assist with outbreak investigations in 2022.

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.

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.

Due to continued travel restrictions and resource constraints this meeting continues to be on hold.

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 plans to continue sampling of surface water for C. cayetanensis at various locations in the US.

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. 

FDA and CDC are working to develop a method to detect C. cayetanensis in wastewater. 

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.