IA #22-02, 3/21/08, "DETENTION WITHOUT PHYSICAL EXAMINATION OF CANTALOUPES
FROM HONDURAS", Attachment 12/22/08
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 product(s) at issue. It does not
create or confer any rights for or any person, and does not
operate to bind FDA or the public)
PRODUCT: Cantaloupes, fresh, frozen and processed (This includes
fresh cantaloupe Sliced/chopped)
PRODUCT
CODE: 22A[]B01
22A[]C01
22A[]D01
22A[]T01
PROBLEM: Salmonella spp.
PAF: MIC
PAC FOR
COLL: 03F098
COUNTRY: HONDURAS (HN)
MANUFACTURER/
SHIPPERS: See Attachment
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 Compliance, Product Adulteration Branch
(HFS-606)
REASON FOR
ALERT: There is currently a multi-state outbreak of Salmonella
Litchfield. CDC reports 58 cases in 16 states (CA, CO, GA,
MO, NJ, NY, OH, OK, OR, TN, UT, WA, WI, AZ, IL, and NM) and
Canada having culture-confirmed Salmonella Litchfield
infections with matching PFGE patterns since January 10,
2008. The serotype is characterized as uncommon. Based on
findings of a case-control study, CDC concluded a
statistical association between consumption of cantaloupe
and illnesses, and requested that FDA initiate a traceback.
Attachment A lists the firm or firms that, based on current
information from the traceback, FDA has determined appear to
be associated with the outbreak. FDA is still continuing
its traceback investigation, however, and will consider
additional traceback and other information it receives in
determining whether it should revise this import alert.
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 an
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 this outbreak of salmonellosis
is due to a random natural event or events in nature. The
outbreak is attributable to a specific, somewhat rare,
species of Salmonella with indistinguishable pulse field gel
electrophoresis (PFGE) pattern. Moreover, the reported
illnesses occurred during a time period that is
approximately three times as long as the shelf-life of the
product, and the illnesses were spread over a relatively
wide geographical area. These factors indicate that the
contamination is more likely due to inadequate controls
rather than a random natural event or events.
Based on the above information and FDA past investigations
of cantaloupe and fresh produce, the source of contamination
would likely be due to one or more of the following:
irrigation of fields with water contaminated with sewage,
processing produce with Salmonella contaminated water,
and/or poor hygienic practices of workers that harvest and
process the produce, animals in close proximity to product
or water sources, and lack of adequate cleaning and
sanitizing of equipment that comes in contact with the
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.
This alert covers both whole cantaloupes 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.
GUIDANCE: Districts may detain, without physical examination, all raw
fresh and raw fresh refrigerated cantaloupes, frozen and
processed cantaloupe, including fresh cantaloupe
sliced/chopped, offered for importation from the firms
listed on the attachment.
If a firm believes that its product should not be
recommended for detention under this import alert, the firm
should forward information supporting its position to FDA at
the following address:
Food and Drug Administration
Division of Import Operations & Policy, HFC-170
5600 Fishers Lane, Room 12-36
Rockville, MD 20857
DIOP will then forward the information to CFSAN for review.
In order to remove a firm from detention without physical
examination, the following should be provided to FDA:
1. information demonstrating that the conditions that
gave rise to the appearance of a violation have been
resolved.
and
2. evidence the agency has confidence that future entries
will be in compliance with the Federal Food, Drug and
Cosmetic Act.
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;
* Steps taken to identify and correct insanitary
conditions.
Further details and examples of the types of information
that can be submitted can be found in FDA's Guidance for
Industry Guide to Minimize Microbial Food Safety Hazards for
Fresh Fruits and Vegetables (October 26, 1998) and FDA's
Final Guidance: Guide to Minimize Microbial Food Safety
Hazards of Fresh-cut Fruits and Vegetables (February 2008).
After reviewing these submissions, FDA, either solely or in
conjunction with the relevant Honduran regulatory authority,
may conduct 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.
Questions may be directed to CFSAN, Office of
Compliance/Product Adulteration Branch (HFS-606) at (301)
436-1742.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Salmonella, pathogens, illness, produce, microbial
contamination
PREPARED BY: Ronald Pace, CFSAN (301) 436-1742
Doug Randes, DIOP (301)443-6553
DATE LOADED
INTO FIARS: March 21, 2008
ATTACHMENT A
FIRMS SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION
"Currently no firms are subject to Detention Without Physical Examination
under this Import Alert"
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