IA #25-18 - 06/04/93, "Automatic Detention of Canned Mushrooms (All
Sizes From Named Manufacturers in Thailand"
TYPE OF ALERT: Automatic Detention
PRODUCT : Canned Mushrooms, (common mushrooms species,
Agaricus only), all can sizes and all product
styles.
PRODUCT CODE : 25PEE____ or
25REE____ or 25QEE
HARMONIZED
CODE : (2003)
PROBLEM : Staphylococcal Enterotoxin (FLST)
PAC FOR
COLLECTION : 03003
COUNTRY : Thailand
MANUFACTURER/
SHIPPER : See Attachment
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "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, 402(a)(4)]."
RECOMMENDING
OFFICE : CFSAN, Division of Enforcement, HFS-605
REASON FOR
ALERT : Industry sources reported to FDA that their
analysis found staphylococcal enterotoxin in one
production code manufactured by each of two
Thailand factories. FDA subsequently confirmed the
presence of staphylococcal enterotoxin in
previously unopened cans from both factories.
Staphylococcal enterotoxin was detected using the
Visual ELISA Method described in the 7th edition
(1992) of FDA's Bacteriological Analytical Manual
(BAM) Chapter 13. The production code found
contaminated from one factory involved a 4 oz. can,
the other factory's contaminated product involved a
68 oz. can.
The presence of staphylococcal enterotoxin can only
occur when there has been gross mishandling of the
product, which would allow for the growth of the
microorganism. Mishandling can be associated with
insanitary conditions during harvesting,
transporting, or processing. These conditions are
likely to exist on any given day and contamination
would not be restricted to particular can sizes or
product styles. Until the cause of contamination
can be identified, it appears that any code lot,
regardless of can size or product style, produced
by the manufacturers may be contaminated with
staphylococcal enterotoxin and represent a
potential danger to public health.
INSTRUCTIONS : Automatically detain all can sizes and product
styles of mushrooms packed by the manufacturers on
the attachment. Because this is a potential health
hazard, any entries which have not been released
are subject to this alert. Samples should be
collected for staphylococcal enterotoxin analysis
on as many entries as possible from other Thailand
manufacturers/shippers.
Note: Product may be labeled "Grown in People's
Republic of China, Packed in Thailand." This is
appropriate since Thailand firms receive brined
mushrooms from PROC which they debrine and can.
Because this alert is issued pursuant to 801(a)(1),
No Reconditioning Will Be Permitted.
FDA will consider removal from automatic detention
when the manufacturer has documented all of the
following: 1) the source of contamination; 2)
appropriate control procedures which have been
instituted to preclude contamination of the
mushrooms with staphylococcal enterotoxin; 3)
compliance with 21 CFR 108.35 and 113.
Any request for removal from automatic detention,
or other inquiries regarding this Import Alert
should be referred to CFSAN/DOE, HFS-607.
To assure the effectiveness of the automatic
detention, these firms are listed in Import Alert
#99-04.
This import alert applies only to mushrooms covered
by the standard of identity, species "Agaricus",
also called champignons. It does not apply to
other species such as golden, abalone, shiitake,
straw, Po-Ku (black) or oyster mushrooms.
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Mushrooms, Staphylococcal Enterotoxin, Thailand,
Canned Mushrooms
PREPARED BY : John Browne, DIOP, 301-443-6553.
ATTACHMENT - IMPORT ALERT #25-18
LIST OF FIRMS ON AUTOMATIC DETENTION
S.K. Foods Co., Ltd.
48 Moo 7 Sretakij Road
Samutsakorn 74110
Thailand
FCE #07863
ID #THSKFOO48SAM
|
