(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 Centers for Disease Control and Prevention (CDC), the U.S. Good and Drug Administration (FDA) and state and local public health officials investigated recurring outbreaks (in 2012, 2013,2014 and 2015) of cyclosporiasis in the United States which have been associated with fresh cilantro from the state of Puebla, Mexico.
Cyclospora cayetanensis (C. cayetanensis) is a human gastrointestinal parasite which causes cyclosporiasis. Humans are the only known host for the parasite. The parasite can cause protracted diarrheal illness in both immunocompetent and immunocompromised humans. Cyclosporiasis is associated with eating foods contaminated with human feces. Immature oocysts that are shed in feces require a period of time, usually 1 to 2 weeks, outside the body (exposed to the environment) to mature and become infective. Therefore, transmission of C. cayetanensis from person-to-person is unlikely. Outbreaks of cyclosporiasis are known to be seasonal, typically occurring from April to August in the United States.
Based on outbreak investigations of cyclosporiasis conducted between 2012-2015, the FDA believes it is extremely unlikely that these recurring outbreaks of cyclosporiasis linked to cilantro from the State of Puebla, MX are caused by isolated contamination events. No single supplier, distributor, farm or packing house can explain all the illnesses. FDA also identified C. cayetanensis in cilantro from multiple firms in Puebla during routine and targeted testing. Thus, FDA believes cilantro contaminated with C. cayetanensis is attributable to multiple farms and packing houses.
Sources of C. cayetanensis may include water contaminated with sewage and portable and fixed latrines that leak or are inadequately cleaned and maintained. Workers may track mature oocysts into the field from soil contaminated by leaking or inadequately maintained latrines. Fields and produce may also be contaminated through contaminated irrigation and crop protection spray water, packing water or ice, as a result of poor hygienic practices during harvesting and packing and inadequate cleaning of food contact surfaces.
From 2013-2015, 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, where they found conditions and practices that may have resulted in the contamination of cilantro and other produce with human fecal pathogens. Objectionable conditions observed at multiple firms in the state of Puebla, MX including human feces and toilet paper found in growing fields and around packing houses; inadequately maintained toilets and hand washing facilities (lacking soap, toilet paper, running water, and/or paper towels) or a complete lack of toilet and hand washing facilities; food-contact surfaces visibly dirty and not washed; and water used for washing cilantro vulnerable to contamination from sewage/septic systems. In addition, at one such firm, water in a holding tank used for hand washing at the bathrooms was found to be positive for C. cayetanensis.
Based on this evidence, FDA concludes that fresh cilantro imported from the state of Puebla, MX appears to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (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 C. cayetanensis outbreaks warrant detaining cilantro from the state of Puebla, MX during April 1 through August 31 of every year. ***
***The Notes section of each firm listing on the Green List should be reviewed, as it lists specific approved farm sources. ***
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 does not consider submission of private laboratory analytical results indicating the absence of C. cayetanensis to be sufficient to overcome the appearance that 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, firms 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, MX may have multiple names, addresses, and registration numbers. Additionally, some firms have been sourcing cilantro from the state of Puebla, MX and declaring their suppliers to be located outside of the state of Puebla, MX. 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 about the location of the farms where the cilantro was sourced. If source farm documentation is unable to be provided, FDA may detain the product. ***
Requests for Removal of Individual Firm or Shipments from Detention Without Physical Examination Under This Import Alert***(addition to Green List)***:
***If a firm would like to request removal from DWPE, information should be provided to FDA demonstrating that the conditions or practices that gave rise to the appearance of a violation have been resolved so that the Agency will have confidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act. 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.
Firms that would like to petition FDA directly, FDA recommends that the submission include documentation that the firm has implemented practices, processes, and procedures that prevent contamination of cilantro with C. cayetanensis from:
- Water. When used in contact with cilantro for irrigation, crop protection sprays, packing, and cooling. If relying on testing for indicator organisms, such as generic E. coli, for the adequacy of water, samples must be taken from untreated water in order to be considered as evidence that the water is not a potential source of C. cayetanensis;
- Workers. May include evidence of worker training and monitoring of worker health and hygiene;
- Latrines and hand washing stations. May include information on how latrines are maintained, cleaned, and located to prevent contamination of cilantro in the field and packing operations. May also include methods of disposal of cleaning water and sewage; and
- Equipment and tools. Harvesting and packing equipment that may come into contact, directly or indirectly with cilantro. May include information on proper cleaning and maintenance of tools and equipment.
In the past some firms submitted evidence of addition of lime (calcium hydroxide) as evidence that they are controlling the hazard of C. cayetanensis associated with spills from latrines. Others have cited the addition of chlorine to demonstrate that their water is safe. FDA is unaware of evidence demonstrating that lime or antimicrobials are effective against C. cayetanensis. If relying on chemical or physical treatments for water or sewage, may include scientific support for the validity of those treatments.
To facilitate our review of petition submissions, we recommend that all documents, except copies of original records, are in English.***
***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. ***
***Additional guidance may be accessed on FDA's website, www.fda.gov. Firms may wish to refer to FDA's guidance, "Cyclosporiasis and Fresh Produce" and "Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."***
For additional guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE).
If a firms and/or representative would like to submit a petition for removal from detention without physical examination by inclusion on the Green List of the Import Alert, all relevant information supporting the request should be forward to 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 with regard to human food on policy, or other any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
appears to have been manufactured, processed, or packed under insanitary conditions."[Adulteration,
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: Cilantro
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)