Import Alert 28-11

REVISION TO IMPORT ALERT #28-11, "Detention Without Physical Examination of *** Aromatic Herbs Due to the Presence of CYCLOSPORA CAYETANENSIS" ***

The revision of this Import Alert dated 12/21/2011, combines Import Alert 28-10 and 28-11, which both deal with the issue of Cyclospora cayetanensis in aromatic herbs. With the issuance of this Import Alert, Import Alert 28-10 is cancelled. Changes include an update of the Import Alert name; update of the alert to the current format and terminology; and updates to the "Reason for Alert" and "Guidance" sections. Changes are noted and bracketed by three asterisks (***).

*** Cyclospora cayetanensis is a protozoan parasite that causes cyclosporiasis and is contracted by consuming food or drinking water contaminated with human feces from infected individuals. No non-human sources of the parasite are known to exist. This fact, in conjunction with the other evidence, led FDA to conclude that products found to contain Cyclospora cayetanensis were contaminated as a result of insanitary conditions in the production or packing operations, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply.

Cases of food-borne illness episodes in 1999 and 2005 have been linked to Cyclospora cayetanensis in basil.

Food products found to contain Cyclospora cayetanensis may be considered adulterated and, if adulterated, are subject to refusal of admission. ***

Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert.

Because the products appear to have been manufactured, processed or packed under insanitary conditions, FDA does not generally consider results from analytical testing of the product upon entry into the United States indicating the absence of Cyclospora cayetanensis as sufficient to justify release of the product.

*** Foreign processors listed on the Red List of this import alert may request removal from that list by submitting documentation demonstrating the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. ***

In order to assess the adequacy of the firm's agricultural, packing, processing, and transportation practices, FDA suggests that the firm submit the information describing the firm's practices. This information includes, but it not limited to, the following areas:

* Water quality in irrigation, packing, and cooling;
* Manure use and biosolids, animal management;
* Worker health and hygiene;
* Sanitary facilities in field and packing house, and
disposal of sewage;
* Maintenance program for cleaning, sanitizing
equipment;
* Field and packing facility sanitation;
* Transportation.
* Proof of an adequate search for the source of the contamination;
* Development of a corrective action plan;
* Sustained implementation of an appropriate food safety program and corrective action plan.

The above documentation should be submitted to FDA's Center for Food Safety and Applied Nutrition at the following address:

***
Food and Drug Administration
Manufacturing and Storage Adulteration Branch (HFS-607)
5100 Paint Branch Parkway
College Park, MD 20740 ***

Further details and examples of the types of information that may be useful in submissions can be found in FDA's Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables located at:
http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/produceandplanproducts/ucm064458.htm

After reviewing these submissions, FDA, either solely or in conjunction with the relevant foreign regulatory authority, may conduct another inspection of the firm to verify the information submitted to FDA. The Agency may consider evidence from the foreign government in establishing that the probable cause of Cyclospora cayetanensis contamination has been identified and appropriate corrective action has been taken.

For questions or issues concerning science, science policy, sample collection, analysis, preparation or analytical methodology, contact the Division of Field Science at 301-796-6600.

***Basil, Mesclun and other aromatic herbs such as Rosemary, Oregano, Tarragon, Marjoram, Arugula, Thyme, Mint, and Sage***


PRODUCT
CODE: *** See Red List ***

The article is subject to refusal of admission pursuant to Section 801(a) (3) in that such article appears to contain Cyclospora cayetanensis, a poisonous or deleterious substance which may render it injurious to health [Adulteration, Section 402(a)(1)]

OASIS Charge Code: POISONOUS

And/Or

"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 been contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 402(a)(4)]."

OASIS Charge Code: INSANITARY

And/Or

"The article is subject to refusal of admission pursuant to Section 801(a)(1) of the act in that it appears to have been manufactured, processed or packed under insanitary conditions [Adulteration, Section 402 (a)(4)."

OASIS charge code - MFR INSAN