IA#25-12 --- 12/7/90, REVISED
TYPE OF ALERT: Automatic Detention
PRODUCT : Canned Mushrooms, (common mushrooms, species Agaricus only),
all can sizes and all product styles
PRODUCT CODE : 25SEE01
HARMONIZED
CODE : 2003.10.0027 2003.10.0043
2003.10.0031 2003.10.0053
2003.10.0037
PROBLEM : Staphylococcal Enterotoxin (FLST)
COUNTRY : Republic of Korea (KR,515)
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) and 801(a)(3) in that it appears to contain
staphylococcal enterotoxin, a poisonous and deleterious
substance which may render it injurious to health
[adulteration, 402(a)(1)], and it appears to have been
prepared, packed or held under insanitary conditions whereby
it may have been rendered injurious to health [adulteration,
402(a)(4)]."
RECOMMENDING
OFFICE : CFSAN, Division of Regulatory Guidance, HFF-310
REASON FOR
ALERT : We have found and confirmed the presence of staphylococcal
enterotoxin in one code lot of canned mushrooms, pieces and
stems, packed by one Korean processor. CFSAN/Division of
Mocrobiology has confirmed the findings using the TECRA ELISA
kit for Staphylococcal Enterotoxin Determination and AOAC 15th
Edition Section 976.31.
Canadian officials have found (we confirmed) staphylococcal
enterotoxin in one code lot from another firm and two code
lots from a third firm. These positive lots were of whole
mushrooms.
There are unconfirmed reports that mushroom processors in
Korea often use mushrooms from the Peoples Republic of China
(PRC). We have previously identified a staphylococcal
enterotoxin problem in mushrooms from the PRC (refer to
Import Alert #25-11). 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, and can be associated with insanitary
conditions during harvesting, transport, 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 factories listed in
attachment A 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 Attachment A. Field
exams and sample collections for staphylococcal enterotoxin
should continue on as many entries as possible from other
Korea manufacturers/shippers, following the procedures
outlined in the completed Korean Canned Mushroom Assignment
(July 5, 1990).
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 the source of contamination; has
documented that appropriate control procedures have been
instituted to preclude contamination of the mushrooms with
staphylococcal enterotoxin; and has provided evidence that it
has complied with 21 CFR 108.35 and 113. Any request for
removal from automatic detention must be referred to
CFSAN/DRG, HFF-310.
This import alert applies only to mushrooms covered by the
standard of identity, species "Agaricus". It does not apply
to other species such as golden, abalone, shiitake, Po-Ku
(black) or oyster mushrooms.
KEYWORDS : Canned mushroom, Korea, Staphylococcal, Enterotoxin, Staph
FOI : No purging is necessary.
Attachment A 12/7/90
1. Woo-Il Industrial Co., Ltd.
53 Yung Bon-Ri, On Yang-Up
ASAN-KUN, 333, Korea
FCE # 05259
2. Sam Yang Moolsan Co., Ltd.
729 Sanbook-Ri, Mi-Myum, Okku-Kun
Chunrabukoo, 511, Korea
FCE# 05268
3. Keum Han Co.
211-1 Yun Jung-Ri, Wolchon-Myun
Kim Je-Kun, Chun Buk, Korea
FCE# 07642
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