(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
The previous revision to this Import Alert dated August 27, 2015 updated the guidance section to provide clarification to SENASICA and COFEPRIS' processes.
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.
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 Comisión 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.
co during April 1 through August 31 of every year.
This alert covers fresh cilantro, whether it is intact or has been cut or chopped (i.e., "fresh cut"). Cutting and chopping cilantro increases the opportunity for contamination and the chance of cross-contamination over an even larger volume of product. However, 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).
Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of C. cayetanensis to be insufficient to overcome the appearance the product has been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.
To facilitate entry review of shipments from firms not located in the state of Puebla, Mexico, importers should provide documentation (i.e., invoices, bills of lading) declaring the source farm(s). FDA has found that firms producing cilantro in the state of Puebla often do business under multiple names, addresses, and registration numbers, and some firms declaring their suppliers to be located outside of the state of Puebla have in fact been sourcing cilantro, at least in part, from the state of Puebla. If documents declaring the source(s) of the cilantro are not provided at the time of entry, this may cause a delay in review of the entry and FDA may request documentation on the location of the farms where the cilantro was sourced. If you find that you are unable to provide source farm documentation, FDA may detain your product as appearing to be sourced from Puebla.
Requests for Removal of Individual Firm or Shipments from Detention Without Physical Examination Under This Import Alert:
Mexican firms from the state of Puebla that are not listed on the Green List of this import alert wishing to ship product during April 1 through August 31 should provide information to FDA to adequately demonstrate that they have in place appropriate measures to overcome the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. Verification of these practices may occur through inspection and certification of farms by SENASICA for recognition in their System for Reduction of Risk from Contamination (SRRC) program and inspection and listing by COFEPRIS of processing facilities complying with Good Production Practices FDA, encourages firms growing, harvesting and holding cilantro to participate in the SENASICA's SRRC program and firms packing cilantro to obtain approval of COFEPRIS for compliance with Good Production Practices.
Alternately, for firms not participating in the SRRC who petition the FDA directly, FDA (either solely or in partnership with the relevant Mexican regulatory authority) may conduct a limited number of on-site inspections of the growing/processing areas to audit the validity of the information submitted to FDA.
For firms that petition FDA directly, FDA recommends that the firm's submission be organized according to the following areas, as appropriate to the firm's practices, processes, and procedures:
- Water adequacy for irrigation, agricultural sprays, cooling, and other uses;
- Soil amendment and biosolids;
- Animal management;
- Worker health and hygiene;
- Sanitary facilities, disposal of sewage and silage;
- Equipment cleaning and sanitation;
- Farm or facility sanitation;
- Transportation; and
- Programs to monitor produce safety practices, processes and procedures, and to take corrective actions when measures fail or are not fully implemented.
The firm may wish to refer to FDA's Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, or similar guidance, to assist them in the development of their submission.
Findings of insanitary conditions at firms producing commodities other than cilantro may lead the FDA to add the firm to other existing import alerts.
***For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at:
Mexican firms who want to request removal from detention without physical examination by inclusion on the Green List of the Alert, should forward information supporting their request for addition on to the Green List to FDA at the following address:
Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
Requests for removal from detention without physical examination will be evaluated by DIO and referred to the CFSAN Office of Compliance, Division of Enforcement for review.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at firstname.lastname@example.org
Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***
PROBLEM: Cyclospora cayetanensis, Insanitary Conditions
OASIS Charge Code: MFR INSAN
***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." [Adulteration, Section 402(a)(4)]***
OASIS Charge Code: INSANITARY
(24 T - - 46) Cilantro (Leaf & Stem Vegetable)Desc: CilantroNotes: PROBLEM; Cyclospora cayetanensis; Insanitary Conditions
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)