IA #20-04, 5/9/08, "IMPORT ALERT #20-04 "DETENTION WITHOUT PHYSICAL
EXAMINATION OF IMPORTED RASPBERRIES FROM GUATEMALA FROM MARCH 15 THROUGH
AUGUST 15, 2008"
NOTE: This import alert is being reissued to provide guidance for
all entries of fresh raspberries from Guatemala.
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
(Note: This import alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or product(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 Raspberries
PRODUCT
CODES: 20A[]B12 Black raspberries
20A[]C12
20A[]B13 Red raspberries
20A[]C13
20A[]B99 Golden raspberries
20A[]C99
PROBLEM: Cyclospora
PAF: MIC
PAC FOR
COLLECTION: 03R175
COUNTRY: Guatemala (GT)
MANUFACTURER/
SHIPPERS: All (except those listed in the Attachment)
MANUFACTURER/
SHIPPER
FEI#: All (except those listed in the Attachment)
CHARGE: 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)
RECOMMENDING
OFFICE: ORO/Division of Import Operations and Policy, HFC170 and
CFSAN/ Office of Field Programs, Imports Branch, HFS606
REASON FOR
ALERT: In the spring of 1996 and 1997, there were numerous
outbreaks of cyclosporiasis in the United States and Canada
reported to FDA by the Centers for Disease Control and
investigations and other data implicated fresh red
raspberries from Guatemala. The geographical results of the
investigations and data justified detaining all raspberries
from Guatemala based upon the appearance of a violation.
During the spring of 1998 (March 15 through August 15,
1998), fresh raspberries from Guatemala were not allowed
entry into the United States.
In November and December, 1998, FDA representatives visited
a number of Guatemalan raspberry farms to determine if farms
wishing to export fresh raspberries to the US in spring 1999
were following the "Model Plan of Excellence" for the export
of raspberries (MPE). The MPE is designed to ensure that
conditions that lead to violations of this type within the
scope of this import alert would not occur. Raspberries
from growers found to be following the MPE were not subject
to detention without physical examination.
For the 2008 spring growing season, Guatemalan raspberry
farms should once again follow the MPE in order to export to
the United States. Farms following the MPE should not be
subject to detention without physical examination for the
reasons in this import alert and will be identified on the
Attachment to this import alert.
NOTE: This import alert does not include coverage of frozen
red, black or golden raspberries or fresh or frozen
blackberries from Guatemala.
GUIDANCE: Districts may detain fresh raspberries (red, black, or
golden) offered for importation from Guatemala without
physical examination from March 15, 2008, through August 15,
2008.
Farms listed in the Attachment to this import alert should
not be subject to detention without physical examination for
the reasons in this import alert. As other growers (farms)
are determined not to be subject to detention without
physical examination, they will also be identified in the
Attachment.
From observations made by FDA experts during visits to the
Guatemalan berry farms, there appear to be no differences
between the cultivation, harvesting and packing processes of
the various colors of raspberries. Because all colors of
raspberries have the same type of surface area, all may
carry the same risk for Cyclospora contamination and
therefore, all appear violative and have been included in
the scope of this import alert.
Because of the difficulty in detecting Cyclospora
contamination in fresh raspberries, testing of the product
upon entry into the U.S. will normally not be sufficient.
However, the agency will consider evidence in conformity
with CFSAN's letter to the Guatemalan Berry Commission,
dated November 20, 1997, to establish that the cause of
Cyclospora contamination in fresh raspberries produced by
Guatemalan growers has been identified and appropriate
corrective action has been taken. Based on evidence
presented, additional farms may be added to the Attachment
as appropriate.
If any entries of raspberries are detained for the reasons
in this import alert, districts are requested to contact
Rosemary Gary, CFSAN, Product Adulteration Branch, at 301-
436-2058 for further guidance and to report information
about the detention (i.e., identification of growers and
consignees).
FOI: No purging is required
KEYWORDS: Raspberries, Cyclospora, Berries, Guatemala
PREPARED BY: Ted Poplawski, DIOP, 301-443-6553
Rosemary Gary, CFSAN, HFS-606, 301-436-2058
DATE LOADED
INTO FIARS: May 9, 2008
ATTACHMENT TO IMPORT ALERT #20-04
GROWERS (FARMS) NOT SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION
(Currently there are no farms listed on this attachment)
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