Import Alert 25-12

"Detention Without Physical Examination of Canned Mushrooms (All Sizes) for Named Manufacturers from South Korea and Continued Surveillance"

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 the Red List may be contaminated with staphylococcal enterotoxin and represent a potential danger to public health.

Districts may detain, without physical examination, all can sizes and product styles of mushrooms packed by the manufacturers on the Red List of this alert. 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 detention without physical examination 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 detention without physical examination must be referred to CFSAN, Division of Enforcement, HFS-605.

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.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.

Canned Mushrooms, (common mushrooms, species Agaricus only), all can sizes and all product styles

"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)]."

OASIS charge code - POISONOUS

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)]."

OASIS charge code - INSANITARY