IA #28-11 - 7/07/06, IMPORT ALERT #28-11 "DETENTION WITHOUT PHYSICAL
EXAMINATION OF FRESH BASIL AND MESCULIN DUE TO THE PRESENCE OF CYCLOSPORA
CAYETANENSIS"
The revision to this import alert was made by CFSAN, HFS-606, to maintain the
alert in place after the firm/products which were the initial subject of this
alert had been removed from detention without physical examination.
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)
(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).
PRODUCT: Fresh (Raw) Basil and Mesculin
PRODUCT
CODE: 28A[]B04/28A[]C04/28A[]T04 - Basil
25E[]B95/25E[]C95/25E[]T95 - Fresh Shredded Mixed
Vegetables For Salads
24T[]B47/24T[]C47/24T[]T47 - Mesculin (Mesclun)
PROBLEM: Cyclospora cayetanensis
PAF: MIC
PAC FOR
COLLECTION: 03R175
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER FEI#: See attachment
IMPORTER'S
FEI#: See attachment
CHARGE: "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)]."
And
"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)]."
And
"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."
OASIS CHARGE
CODE: POISONOUS
INSANITARY
MFR INSAN
RECOMMENDING
OFFICE: Imports Branch, Division of Enforcement, Office of
Compliance, CFSAN (HFS-606)
REASON FOR
ALERT: Fresh (raw) basil was implicated by an investigation of
Outbreaks of cyclosporiasis (infection with the parasite
Cyclospora cayetanensis) that occurred in the spring of
2005, in multiple counties in Florida.
Cyclospora cayetanensis is a protozoan parasite that is
contracted by eating 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 the implicated products 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.
GUIDANCE: Districts may detain, without physical examination, all
fresh raw basil and mesclun from the firm(s) identified in
the attachment to this Import Alert. Because the products
appear to have been manufactured, processed or packed under
insanitary conditions, FDA does not generally intend to
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.
Firm(s) subject to this alert should forward information
establishing that the conditions that gave rise to the
appearance of a violation have been resolved to the
following address:
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance
Division of Enforcement/Imports Branch (HFS-606)
5100 Paint Branch Parkway
College Park, MD 20740
In order to assess the adequacy of the firm's agricultural,
packing, processing, and transportation practices, FDA
personnel intends to review submitted information describing
the firm's practices. This information should include, but
is 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.
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 (63 FR 58055, October 29, 1998:
www.foodsafety.gov/~dms/prodguid.html).
In addition, in order to assess the adequacy of the firm's
response to the outbreaks, FDA personnel intend to review
submitted information describing the firm's corrective
actions. This information should include, but is not limited
to, the following areas:
* 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.
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 contamination in fresh
(raw) Basil and Mesclun produced by the implicated firm has
been identified and appropriate corrective action has been
taken.
Questions may be directed to Doriliz De Leon, CFSAN, HFS-
606, at 301-436-2772 or Sal Evola, CFSAN, HFS-606, at 301-
436-2164.
Questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, may be directed to the Division of Field
Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Produce, Cyclospora, pathogens, microbial contamination,
food borne outbreak, epi data
PREPARED BY: Ted Poplawski, DIOP (301) 443-6553
CFSAN, Office of Compliance, Imports, 301-436-2413
DATE LOADED
INTO FIARS: July , 2006
Under the Authority of
Domenic Veneziano, CDR USPHS
Attachment
(Currently there are no firms/products listed in the attachment)
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