FDA noted that it is “extremely unlikely” that these outbreaks are due to isolated contamination events because of their recurring nature, the timing (typically April to August of each year), and because of the association with cilantro from Puebla. No single supplier, packing date, shipping date, or lot code can explain all the illnesses, the agency added. Further, “FDA believes the source of C. cayetanensis contamination is likely attributable to a broader source of contamination. Sources of contamination may include fecal contamination of growing areas, irrigation of fields with water contaminated with sewage, cleaning or cooling produce with contaminated water, and/or poor hygienic practices of workers that harvest and process the produce, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product.” The agency and its regulatory counterparts in Mexico have been investigating farms and packing houses in Mexico, including those in Puebla, to check on conditions and practices which may have resulted in contaminating the cilantro. From 2013-2015, officials with agencies from both countries inspected 11 farms and packing houses that produce cilantro in the state of Puebla, 5 of them linked to the US C. cayetanensis illnesses, and observed objectionable conditions at 8 of them, including all five of the firms linked through traceback to the U.S. illnesses, FDA stated. “Conditions observed at multiple such firms in the state of Puebla included human feces and toilet paper found in growing fields and around facilities; inadequately maintained and supplied toilet and hand washing facilities (no soap, no toilet paper, no running water, no paper towels) or a complete lack of toilet and hand washing facilities; food-contact surfaces (such as plastic crates used to transport cilantro or tables where cilantro was cut and bundled) visibly dirty and not washed; and water used for purposes such as washing cilantro vulnerable to contamination from sewage/septic systems,” the alert stated. “In addition, at one such firm, water in a holding tank used to provide water to employees to wash their hands at the bathrooms was found to be positive for C. cayetanensis. Based on those joint investigations, FDA considers that the most likely routes of contamination of fresh cilantro are contact with the parasite shed from the intestinal tract of humans affecting the growing fields, harvesting, processing or packing activities or contamination with the parasite through contaminated irrigation water, contaminated crop protectant sprays, or contaminated wash waters,” FDA stated. Because of these problems, FDA has concluded that imported fresh cilantro (whether cut or chopped) from Puebla, Mexico, appears to be adulterated and is therefore subject to refusal of admission into the U.S. However, FDA noted, multi-ingredient processed foods that contain cilantro as an ingredient are not covered under this alert and neither is cilantro that has been processed in other ways besides being cut or chopped (e.g., dried). Cyclospora cayetanensis is a human-specific protozoan parasite that causes a prolonged and severe diarrheal illness known as cyclosporiasis. In order to become infectious, the organism requires a period outside of its host. Illnesses are known to be seasonal and the parasite is not known to be endemic to the United States. Cyclosporiasis occurs in many countries, but it seems to be most common in tropical and subtropical regions. People become infected with C. cayetanensis by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) C. cayetanenis oocysts in the feces.

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