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FDA Releases Cyclospora Prevention, Response and Research Action Plan

The agency said the plan focuses on improving prevention, enhancing response activities and filling knowledge gaps in order to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.

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Editor's Note: Read more about how Cyclospora is impacting the produce industry in this column from Jennifer McEntire, senior vice president of food safety at United Fresh Produce Association.

SILVER SPRING, Md. —  As part of the Food and Drug Administration's ongoing efforts to combat foodborne illness and aligned with its New Era of Smarter Food Safety initiative, the FDA, this week, released the Cyclospora Prevention, Response and Research Action Plan. Modeled after its Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan, the plan focuses on improving prevention, enhancing response activities and filling knowledge gaps in order to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.

 
Cyclosporiasis is a foodborne intestinal illness caused by Cyclospora cayetanensis. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea and fatigue. Cyclospora is historically associated with imported produce or travel outside the United States; however, FDA said it has also detected Cyclospora in domestically produced foods in recent years.
 
FDA first documented Cyclospora in domestically grown produce (cilantro) in 2018 as part of an ongoing sampling assignment of fresh herbs. The testing was done as part of a surveillance sampling, and the cilantro sample was not linked to any illnesses or outbreaks. Not long after, domestically grown produce was again associated with an outbreak linked to a salad mix. During FDA’s investigations into this outbreak, Cyclospora was also detected in an unused package of the salad containing domestically grown produce.
 
The availability of new testing methods for Cyclospora developed at FDA’s Center for Food Safety and Applied Nutrition played an important role in helping FDA identify these positive samples of Cyclospora in the cilantro and in the salad mix, the agency said. The number of reported cases of this foodborne illness has been rising in recent years, in part because of better diagnostic and detection methods. According to the Centers for Disease Control and Prevention, there have been roughly 6,000 domestically acquired cases of Cyclospora over the last three years. The number of reported cases typically rises during the spring and summer, usually in May, June and July. Rising case numbers and the emergence of Cyclospora contamination in domestically grown produce prompted FDA to create 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.
 
The task force formulated the action plan announced this week, which FDA said will serve as a strategic guide to improve prevention, enhance response activities and fill knowledge gaps about the presence of Cyclospora in or on foods. In the area of prevention, the new action plan highlights how FDA is addressing this food safety issue through the development and delivery of prevention-focused education materials and outreach to stakeholders. The agency is also working with industry to encourage the development of rapid test kits to specifically detect Cyclospora to better facilitate industry testing and root cause analysis activities. In addition, FDA is planning to collaborate with industry to look for ways to more effectively control Cyclospora in the environment and on farms.
 
In the area of response, the plan is focused on expanding laboratory capacity across FDA, state, foreign partners and academia to sample and test for Cyclospora, providing greater capacity to investigate during outbreak events. FDA is also developing a new investigational tool to help guide assessments of farms potentially implicated in a Cyclospora outbreak to determine potential sources and routes of contamination.
 
Given the emerging nature of Cyclospora contamination in domestic produce, a large number of action items in this plan are aimed at addressing knowledge gaps, FDA said. In this area, FDA intends to work with CDC to better understand the case distribution of cyclosporiasis across the U.S. and to advance genotyping methods in clinical, food and environmental samples that will allow us to genetically link clinical cases to food products and environments identified by traceback during an outbreak. As part of this plan, FDA also said it intends to work with industry and academia to better understand the prevalence of Cyclospora in agricultural water and to encourage data sharing to help stakeholders identify trends associated with Cyclospora contamination. FDA said its action plan underscores the importance of collaboration across industry, academia, state, federal and foreign government partners, and other stakeholders to reduce the risks and public health burden caused by foodborne Cyclospora. The agency said it will continue updating this plan as actions are completed and new actions are identified.