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TAG September 26, 2018 0 Comments

​​If we’d written about Cyclospora a year or so ago, many readers would likely have asked “Cyclo-what?” Today the word – and all its repercussions for the food industry in particular – has become pervasive. The “big news” started with two major cyclosporiasis outbreaks earlier this year, then it was FDA’s discovery of Cyclospora in its sampling of herbs (which we discussed in last week’s newsletter) over the summer, and the commissioner’s statement on the agency’s “ongoing efforts to prevent food outbreaks of Cyclospora” (mentioned last week). As a result, we’re now seeing newly updated CDC cyclosporiasis webpages and numerous new medical and health site postings on this intestinal illness caused by the microscopic parasite Cyclospora cayetanensis. This is particularly significant because Cyclospora is being detected in domestically sourced produce as well as imports. Finding Cyclospora in domestic produce is a game changer from my perspective in terms of new risks associated with U.S. produce. So, let’s take a deeper dive into what is going on and what it all means, particularly in relation to our opening statement last week that “If you are selling produce or using produce you need to keep Cyclospora in mind because the FDA Commissioner certainly has it on his mind.” On September 18, FDA Commissioner Scott Gottlieb discussed just what is on his mind when he issued a statement on the agency’s ongoing efforts to prevent foodborne outbreaks of Cyclospora. With 2,173 cases of domestically acquired cyclosporiasis recorded by CDC over the spring and summer, the year has been notable for the number of reported cases. Though some of this was likely due to improved public health monitoring, FDA sees Cyclospora as a new risk on which increased focus should be placed. There were two large produce-associated outbreaks to which the Cyclospora illnesses were linked, including 250 illnesses in four states linked to Del Monte vegetable produce trays and 511 illnesses from 16 states linked to a McDonald’s salad mix supplied by Fresh Express, both of which have been declared to be over. While large, these two outbreaks still accounted for less than half of all domestically acquired Cyclospora cases reported to CDC in 2018. Smaller clusters of Illnesses have been found linked to basil and cilantro in Mexican-style restaurants and FDA’s market survey of fresh herbs identified Cyclospora in cilantro offered for import from two producers in Mexico. But FDA had Cyclospora on its mind well before that: In 2015, the agency established the Foodborne Parasitology Research Program specifically to create a new, more sensitive method to detect the parasite. And the researchers did just that, developing real-time PCRs for cilantro, raspberries, shredded carrots, parsley, and basil, which replaced all aspects of previous FDA methods in 2017. It was this method that FDA used in its surveillance sampling of fresh herbs. In conducting its new, routine testing for Cyclospora in certain commodities, such as herbs, FDA identified a number of positive samples in domestically grown cilantro. Although it has not been linked to any illnesses, it did signify the first time that Cyclospora was detected in domestically grown produce. Thus, the discovery of Cyclospora in both domestic and imported produce is raising old and new concerns for FDA, underscoring the importance of its surveillance activities, and stressing the need for the agency to broaden the tools it has used to prevent Cyclospora illnesses to include those that more specifically address domestic contamination. So if you read last week’s newsletter and the various news items and online reports about Cyclospora contamination and thought, “That doesn’t apply to me because I don’t import produce or herbs,” or even just figured you had enough to think about in testing for “the big three,” Salmonella, Listeria, and E. coli, you may want rethink that and add a fourth to your list. If FDA is so focused on Cyclospora that it established a program to develop a test for it, and is conducting routine testing for the parasite, it is an area that should be of concern to you as well. While testing for the parasite is a reactive practice, FDA sees its findings as also highlighting the significance of implementation of the Produce Safety Rule at both domestic and foreign establishments. So, should you be doing something different to control Cyclospora? The short answer should be “No.” Cyclospora is spread as a result of poor personal hygiene like many other foodborne pathogens. But given the new focus it is all the more important to look at the way you are controlling personal hygiene requirements of your suppliers if you are buying produce, or of your workers if you are growing or harvesting produce. This is exactly what you should be doing to be compliant with the produce rule. But it is my bet that FDA will be looking at those programs on farms in more detail. And if FDA is not doing that, they should be! So, for those subject to the produce rule, be sure you are putting its science-based measures in place, and those further down the food chain, be sure your supply-chain program includes requirements for and monitoring of your suppliers’ compliance with the rule. About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain.  With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at:


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