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FDA documents first Cyclospora contamination of U.S. fresh produce

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A special FDA testing program on fresh herbs has documented the first confirmed evidence of the Cyclospora parasite in U.S. produce.

The Food and Drug Administration found the microscopic parasite on fresh cilantro at a U.S. distribution facility in July. In a follow-up investigation, the FDA found Cyclospora on fresh cilantro at a farm. The federal agency worked with state and local officials to embargo the cilantro. Staff from FDA have been working with the farmer on “corrective actions geared toward common routes of contamination,” according to a constituent update from the agency. 

“Although this is the first confirmed evidence of the presence of Cyclospora in domestic produce, FDA is currently unaware of illnesses associated with the product, and traceforward efforts do not indicate there are any connections between this domestic finding of contaminated cilantro and multistate outbreaks of Cyclospora illnesses investigated this spring and summer,” the agency reported.

Those Cyclospora outbreaks were linked to Del Monte vegetable-dip trays and salads made with Fresh Express chopped lettuce and carrots that were served at McDonald’s restaurants.

The special testing program also found Cyclospora on two samples of fresh samples from Mexico. The FDA refused entry for the shipments and is taking action to prevent contaminated cilantro from those firms from entering the U.S. Also, as part of the FDA Produce Safety Partnership with Mexico, the two countries are investigating the cause of contamination.

In addition to cilantro, the herb sampling program for federal fiscal year 2018 included basil and parsley. The FDA selected those specific herbs for the testing program because they are usually eaten without undergoing a “kill step” such as cooking to reduce or eliminate pathogens. Also, because the herbs are grown low to the ground, they are particularly susceptible to contamination.

Initially the FDA was going to test the fresh herb samples for only Salmonella and Shiga toxin-producing E. coli (STEC).

“The agency added to this sampling assignment its recently developed and validated new analytical method to test for the parasite Cyclospora cayetanensis. Cyclospora has caused outbreaks in the U.S. linked to imported produce, including basil and cilantro,” according to FDA. 

“Although it’s unknown exactly how food and water become contaminated with Cyclospora, prior outbreaks have been associated with produce grown under insanitary conditions. This highlights the importance of strong sanitation and worker hygiene practices to prevent contamination, since rinsing or washing food is not likely to remove the parasite.”

Cilantro has been linked to several outbreaks of cyclosporiasis, the infection caused by the Cyclospora parasite, in recent years. Other herbs have also been implicated in other Cyclospora outbreaks.

From 1996 to 2015, the FDA reported nine outbreaks linked to basil, parsley, and cilantro. Those outbreaks caused at least 2,699 illnesses and 84 hospitalizations. Four of the outbreaks were linked to basil, three to cilantro, and two to parsley. 

Of those same nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. 

One of the goals of the special testing program for the herbs it to obtain baseline estimates for the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in cilantro, basil and parsley.

The FDA began developing special sample testing programs, referred to the agency as assignments, in 2014. The program involves collecting 

Beginning in 2014, the agency began developing a new, more robust approach to sampling assignments to assess microbial contamination in food commodities. Under this new approach, a statistically-valid number of samples of targeted foods are collected over 12 to 18 months.

“The sampling design for each food takes into account the volume of the target food that is both imported and produced domestically, and the number of states/countries that produce the target food, to reflect what U.S. consumers are likely to find in the marketplace,” according to the FDA update.

Commodities sampled to date under the new approach have included sprouts, whole fresh avocados, raw milk cheese, cucumbers, and hot peppers. 

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