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FDA Finalizes Action Plan To Prevent Cyclospora Contamination

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The U.S. Food and Drug Administration or FDA, has finalized the cyclospora prevention, response and research action plan in order to help prevent Cyclospora contamination of foods and to help prepare for responding quickly to future outbreaks.

The plan focuses on improving prevention, enhancing response activities and filling knowledge gaps to help prevent Cyclospora contamination of foods. The plan is modeled after the FDA's Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan.

Cyclosporiasis is a foodborne intestinal illness caused by Cyclospora cayetanensis parasite. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea and fatigue.

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. These cases generally rise during the spring and summer, usually in May, June and July.

Though Cyclospora is generally associated with imported produce or travel outside the U.S., it has also been detected in domestically produced foods in recent years. The FDA's first documented Cyclospora in domestically grown produce (cilantro) was in 2018 as part of an ongoing surveillance sampling of fresh herbs.

The FDA also detected Cyclospora in an unused package of the salad mix during investigations into an outbreak. The package contained ingredients that primarily included domestically grown produce.

The FDA then created the Cyclospora Task Force in 2019 to stem the rising case numbers of cyclosporiasis in the U.S. in recent years and the emergence of Cyclospora contamination in domestically grown produce.

This task force formulated the action plan that is now released by the FDA. This action plan will serve as a strategic guide in the prevention of Cyclospora contamination of food.

As for the area of prevention, the new action plan highlights how it will address the food safety issue through the development and delivery of prevention-focused education materials and outreach to stakeholders.

The FDA will also work with industry to encourage the development of rapid test kits to specifically detect Cyclospora to better facilitate industry testing and root cause analysis activities. It will look for ways to more effectively control Cyclospora in the environment and on farms.

As for the area of response, the plan is focused on expanding laboratory capacity across the FDA, state, foreign partners and academia to sample and test for Cyclospora, providing greater capacity to investigate during outbreak events.

The 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.

The knowledge gaps will be addressed by the FDA by working 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. The FDA also intends to work with industry and academia to better understand the prevalence of Cyclospora in agricultural water.

The will enable the FDA to genetically link clinical cases to food products and environments identified by traceback during an outbreak.

The FDA 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.

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