FDA Investigators found:
- 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;
- Water used for purposes such as washing cilantro vulnerable to contamination from sewage/septic systems;
- 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 Cyclospora cayetanensis.
The Centers for Disease Control and Prevention (CDC) and state public health officials have identified annually recurring outbreaks (in 2012, 2013, and 2014) of cyclosporiasis in the United States, which have been associated with fresh cilantro from the state of Puebla, Mexico. There is currently (in July 2015) another ongoing outbreak of cyclosporiasis in the United States in which both the Texas Department of State Health Services and the Wisconsin Department of Health Services and the Wisconsin Department of Agriculture, Trade and Consumer Protection have identified cilantro from the Mexican state of Puebla as a suspect vehicle with respect to separate illness clusters.
Texas DSHS has received reports of 205 Cyclosporiasis cases from around Texas this year, prompting an investigation into the infections in hopes of determining a common source. People who have a diarrheal illness lasting more than a few days or diarrhea accompanied by a severe loss of appetite or severe fatigue should contact their health care provider.
Past outbreaks have been associated with cilantro from the Puebla area of Mexico. While the investigation into the current outbreak is ongoing, imported cilantro has been identified as a possible source of some infections. The U.S. Food and Drug Administration recently issued an import alert detaining cilantro from that area coming into the U.S.
DSHS recommends thoroughly washing fresh produce, but that may not entirely eliminate the risk because Cyclospora can be difficult to wash off. Cooking will kill the parasite.
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.
Based on epidemiological evidence collected by affected domestic states, the CDC and traceback evaluations conducted by FDA, cilantro from the state of Puebla, Mexico was implicated as the vehicle for some of the U.S. cyclosporiasis infections in 2013 and 2014. In addition, after cyclosporiasis illnesses from the 2013 outbreak were linked to cilantro from Puebla, FDA reviewed a cluster of cyclosporiasis illnesses from 2012 in which the state of Texas had previously identified cilantro as one of multiple possible suspect vehicles and determined that cilantro from the state of Puebla, MX was supplied to the point of service implicated in that outbreak. While this means that cilantro from the state of Puebla, MX was one potential source of the 2012 outbreak, this was not confirmed by epidemiological means. The Texas Department of State Health Services has also identified cilantro from the state of Puebla as a suspect vehicle in an ongoing outbreak (as of May 2015). Additionally, in the 2015 outbreak Wisconsin officials have identified cilantro from the state of Puebla, MX as a suspect vehicle for a cluster of illnesses associated with a single restaurant. The source(s) of the 2015 outbreak(s) are still under investigation.
FDA believes it is extremely unlikely that these outbreaks of cyclosporiasis are due to isolated contamination events because of their recurring nature, both in the timing with which they occur (typically April August each year) and the repeated association of illnesses with cilantro from the state of Puebla. No single supplier (including retail outlets or distribution centers), packing date, shipping date, or lot code can explain all the illnesses. 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.
FDA and the Mexican regulatory authorities for farms, packing houses and processors in Mexico, Servicio Nacional de Sanidad, Inocuida y Calidad Agroalimentaria (SENASICA) and the Comisin Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS), investigated farms and packing houses in Mexico, including in the state of Puebla, to ascertain the conditions and practices that may have resulted in the contamination of cilantro. From 2013 to 2015, FDA, SENASICA, and COFEPRIS 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. 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. 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.
The outbreak investigations repeatedly associating cilantro from the state of Puebla, MX with U.S. cyclosporiasis illnesses, and the repeatedly observed insanitary conditions providing likely routes of contamination for C. cayetanensis at multiple firms producing cilantro in the state of Puebla, MX, lead FDA to conclude that cilantro imported from the state of Puebla, Mexico appears to be adulterated under Section 402(a)(4) of the Act because it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. It is therefore subject to refusal of admission under Section 801(a)(3) of the Act. In addition, the cilantro appears to have been manufactured, processed, or packed under insanitary conditions within the meaning of Section 801(a)(1) of the Act. The seasonality of the previous C. cayetanensis outbreaks warrants detaining cilantro from the state of Puebla, Mexico during April 1 through August 31 of every year.