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