IA #22-01, 5/4/06,"DETENTION WITHOUT PHYSICAL EXAMINATION OF CANTALOUPES FROM
MEXICO" ATTACHMENT A 11/14/08 Attachment B 11/14/08
NOTE: Revision to this import alert adds Attachment B and updates the
information in the text. New information is designated by
asterisks (***).
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: Cantaloupes, fresh, frozen and processed (This includes fresh
cantaloupe sliced/chopped for salad bars.)
PRODUCT
CODE: 22A[]B01
22A[]C01
22A[]D01
22A[]T01
PROBLEM: Salmonella spp.
PAF: MIC
PAC FOR
COLL: 03F098
COUNTRY: MEXICO (MX)
MANUFACTURER/
SHIPPERS
FEI: All
CHARGE:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that such article appears to contain
Salmonella, 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 rendered injurious to health [Adulteration, Section
402(a)(4)]."
and
"The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears to have been prepared,
packed, or held under insanitary conditions [Adulteration]"
OASIS CHARGE
CODE: SALMONELLA
INSANITARY
MFR INSAN
RECOMMENDING
OFFICE: CFSAN, Office of Field Programs, Imports Branch (HFS-606)
REASON FOR
ALERT: During 2000, 2001, and 2002, there were four multi-state
Salmonellosis outbreaks traced back to Mexican cantaloupes.
The pathogen identified in three of the outbreaks was
Salmonella Poona and in the other outbreak Salmonella Anatum.
Reported cases per outbreak ranged from 35 to 50. There were
two deaths in California associated with the 2001 outbreak.
At least 18 people were hospitalized. All outbreaks occurred
between March and June. FDA's traceback investigations
implicated Mexican cantaloupe from the states of Michoacan
and Guerrero as the source of the four outbreaks. In 1999,
2001, and 2002, FDA collected samples of Mexican cantaloupes
for Salmonella analysis. The salmonella-positive samples
include nearly all the major cantaloupe producing states in
Mexico including Sonora (7), Jalisco (1), Colima (1),
Coahuila (1), Mexico (1), and Tamauilpas (1). Positive
samples cover both the fall/winter and spring/summer season.
Salmonella lives in the intestinal tracts of humans and other
animals. Thus, the organism may be transmitted to humans by
eating foods contaminated with fecal material from humans or
other animals. Random events in nature, such as animal
defecating on a cantaloupe growing in the field, may cause
the product to become contaminated with Salmonella and,
subsequently, result in illness. However, FDA believes that
it is extremely unlikely that there would be repeated multi-
state outbreaks of salmonellosis, attributable to a specific
species of Salmonella with indistinguishable pulse field gel
electrophoresis (PFGE) patterns if contamination was derived
from random events in nature.
Moreover, in the outbreaks of 2000, 2001, and 2002, the
illnesses were spread over a wide geographical area in the
U.S., as well as in Canada, and occurred over a 4 to 6 week
period. These two facts also suggest that more than one
shipment was the cause and make it extremely unlikely that a
random natural event or events caused the contamination.
FDA believes that the source of Salmonella contamination is
most likely attributable to a broader source of
contamination. Sources of contamination may include
irrigation of fields with water contaminated with sewage,
processing ("cleaning and cooling")produce with Salmonella
contaminated water, and/or poor hygienic practices of workers
that harvest and process the produce, pests in packing
facilities, and lack of adequate cleaning and sanitizing of
equipment that comes in contact with the product.
Inspectional findings (conducted in response to the
outbreaks) at a number of cantaloupe growing areas and
packing sheds in Mexico reveal that Mexican cantaloupe are
indeed manufactured, processed, or packed under gross
insanitary conditions. Further, these inspections underscore
the lack of an overall environmental sanitation program, as
well as apparent lack of regulatory authority in Mexican law
to address the insanitary conditions that FDA believes lead
to Salmonella contamination. In addition, practices that
result in product from different states being commingled
means that any shipment of cantaloupe may contain fruit from
states that have been the source of contaminated cantaloupe.
FDA believes that cantaloupe imported from Mexico appear to
be adulterated under Section 801(a)(3) of the Act because
they appear (1) to contain Salmonella, an added poisonous or
deleterious substance that may render food injurious to
health within the meaning of section 402(a)(1) of the Act
and (2) to have been prepared, packed, or held under
insanitary conditions whereby they may have been rendered
injurious to health within the meaning of Section 402(a)(4)
of the Act. In addition, the cantaloupe violate
section 801(a)(1) of the Act in that they appear to have been
manufactured, processed, or packed under insanitary
conditions.
This alert covers both whole cantaloupe and sliced, chopped,
or diced cantaloupe. The processing associated with
producing fresh versus intact produce increases the
opportunity for contamination and the chance of cross
contamination over an even larger volume of product.
Furthermore, processes such as cutting, dicing, and slicing,
increase the surface area available for contamination and
growth of microorganisms. Nutrients to support microbial
growth (i.e., from plant juices and exposed flesh) are also
more available. Concerns about pathogens are further
amplified when the characteristics of the particular fruit or
vegetable (e.g. pH) can support their growth. This is the
case with many vegetables, certain soft fruit, and melons,
including cantaloupe.
GUIDANCE: Districts may detain, without physical examination, all raw
fresh and raw fresh refrigerated cantaloupes, frozen and
processed cantaloupe, including fresh cantaloupe
sliced/chopper for salad bars offered for importation from
the country of Mexico.
If a firm, grower, processor, packer, or importer believes
that their product should not be recommended for detention
under this import alert, they should forward information
supporting their position to FDA at the following address:
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance/Imports Branch (HFS-606)
5100 Paint Branch Parkway
College Park, MD 20740
In order to assess the adequacy of the firm's agricultural,
processing, and transportation practices, FDA personnel
should review information submitted describing the firm's
practices in 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,
disposal of sewage and Silage;
* Maintenance program for cleaning, sanitizing
equipment;
* Field and packing facility sanitation;
* Transportation;
* If applicable, steps taken to identify and correct
insanitary conditions which are indicated by
positive analytical results for Salmonella in the
firm's product, or as a result of an
epidemiological traceback investigation.
Further details and examples of the types of information that
can be submitted can be found in FDA's draft Good
Agricultural Practices (FR 63 FR 18029, April 13, 1998).
After reviewing these submissions, FDA, either solely or in
conjunction 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. FDA intends to give priority
in scheduling these inspections to firms or growers who
provide certification from an independent institution or
third party that has expertise in agricultural and
transportation processes.
*** On October 26, 2005, the Food and Drug Administration(FDA)
and the Mexican Servicio Nacional de Sanidad Inocuidad y
Calidad Agroalimentaria (SENASICA) signed a Memorandum of
Understanding dealing with Mexican cantaloupe to be imported
to the United States. Under the terms of the MOU, SENASICA
would identify cantaloupe firms as being in compliance with
their Good Agriculture Practices (Lineamientos). This
document is similar to FDA's GAPs and will be used by
SENASICA to determine if a firm is growing and harvesting
cantaloupes under sanitary conditions and can be deemed a
Category 3 firm as described in the MOU. Category 3 firms
will be listed in Attachment B of this import alert.
The purpose of Attachment B is to alert the field to the
names of the Category 3 firms certified by SENASICA for
which the FDA has agreed to allow to ship. The Category 3
firms named in Attachment B will be required to make five
entries and show laboratory results that are negative for
Salmonella as described in the MOU. Once they have five
Shipments shown to be free of Salmonella, the districts
should submit a request to DIOP to have the firms moved to
Attachment A of Import Alert 22-01, which exempt the firms
from DWPE.***
Questions may be directed to CFSAN, Office of Field
Programs/Imports Branch (HFS-606) at (301) 436-2413.
NOTE: 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 Salmonella to be
insufficient to overcome the appearance of the product having
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.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Salmonella, pathogens, illness, produce, microbial
contamination
PREPARED
BY: Ted Poplawski and ***Linda Wisniowski, DIOP (301) 443-6553
DATE LOADED
INTO FIARS: May 4, 2006
ATTACHMENT A FIRMS THAT ARE EXEMPT FROM DETENTION WITHOUT PHYSICAL
EXAMINATION 11/14/08
Firm Name and Address: Product/Codes:
AG Mart Produce S. de R.L. de C.V. Cantaloupes
Blvd. G. Lopez No. 185, int. 205-A 22A[]B01, 22A[]C01,
Guaymas, Sonora, Mexico 22A[]D01, 22A[]T01
FEI: 3003198593 3/20/06
Moved from Attachment B to Attachment A 5/24/06
Agropecuaria Malichita S.A. de C.V. Cantaloupes
Malecon Malpica 189 22A[]B01, 22A[]C01
Guaymas, Sonora 22A[]D01, 22A[]T01
Mexico 6/27/07
FEI# 3001133295
Moved from Attachment B placed on Attachment A 12/12/07
Agroproductos San Rafael SA de CV Cantaloupes
Km. 92 Carreterra International 22A[]B01, 22A[]C01,
Cd. Obregon-Guaymas 22A[]D01, 22A[]T01
Guaymas, Sonora, Mexico 6/20/2007
FEI# 3004347745
Moved from Attachment B to Attachment A 8/24/07
Felipe de Jesus Michel Ruiz Cantaloupes
5 de Mayo 234-2 22A[]B01, 22A[]C01,
Colima, Mexico 28000 22A[]D01, 22A[]T01
FEI #3001618872 06/21/06
Moved from Attachment B to Attachment A 4/27/07
Giadela SPR de RL Cantaloupes
Cuernavaca #23 Col. San Benito 22A[]B01, 22A[]C01
Hermosillo 22A[]D01, 22A[]T01
Sonora 83190 Mexico 3/12/08
FEI# 3004260703
Moved from Attachment B and
Placed on Attachment A
6/27/08
Guadalupe De Guaymas, S.P.R De R.L Cantaloupes
Serdan No. 196-1 Centro Guaymas 22A[]B01, 22A[]C01
Guaymas, Sonora 22A[]D01, 22A[]T01
Mexico 5/3/07
FEI# 3000976900
Moved from Attachment A and placed
on Attachment B 5/27/08
Moved from Attachment B and placed
on Attachment A 11/14/08
** Orval Kent de Linares SA de CV Cantaloupes
aka Chef Solutions 22A[]D01, 22A[]T01
Ave. Dr. Garcia Rodriguez Ote. 204 4/12/03
Linares, Mexico
FEI #1000253286
Note: This applies only to processed cantaloupe from a Mexican
grower already exempt from DWPE or cantaloupe purchased or
grown in the United States.
Vinedos Alta, S.A. de C.V. Cantaloupes
Carretera a Kino, Km 7.5 22A-B01, 22A-C01
Hermosillo, Sonora 22A-D01, 22A-T01
Mexico 5/3/07
FEI# 3000299941
Moved from Attachment B to Attachment A 5/25/07
ATTACHMENT B CATEGORY 3 FIRMS CERTIFIED BY SENSICA TO BE IN COMPLIANCE
WITH GOOD AGRICULTURE PRACTICE AND FOR WHICH FDA HAS
AGREED TO ALLOW TO SHIP 11/14/08
Firm Name and Address: Product/Codes:
AG Mart S.A. de R.L. de C.V. Cantaloupes
Jose Antonio Torres 178-B 22A-B01, 22A-C01
Col. Centro 22A-D01, 22A-T01
Tecoman, Colima 5/3/07
Mexico
FEI# 3005652838
Jorge Patricio Padilla Quezada (Rancho La Borrada) Cantaloupes
Jose Lopez Portillo 2205 22A[]B01, 22A[]C01,
Col. Venticinco de Novembres 22A[]D01, 22A[]T01
Guadalupe, Nuevo Leon, Mexico 4/11/07
FEI# 3004699168
Productores Agricolas, Ganaderos Cantaloupes
y Forestales "El Herradero" 22A[]B01
S.A. de C.V. 22A[]C01
Miguel Hidalgo Ote. No.14 - Altos. 22A[]D01
Vicente Riva Palacios 22A[]T01
Michoacan, Mexico C.P. 61980 8/25/06
FEI# 3004337128
Vinedos Costa S. de R.I. de C.V. Cantaloupes
Calle 28 Norte, Km. 13 22A[]B01, 22A[]C01
Miguel Aleman, C.P. 83205 22A[]D01, 22A[]T01
Hermosillo, Sonora 9/17/08
Mexico
FEI# 3004021193
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