Import Alert 25-18

"Detention Without Physical Examination of Canned Mushrooms (All Sizes From Named Manufacturers)in Thailand"

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.

Districts may detain, without physical examination, 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 detention without physical examination 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 detention without physical examination , or other inquiries regarding this Import Alert should be referred to CFSAN/DE, HFS-605.

To assure the effectiveness of the detention without physical examination , 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.

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) in that it appears to have been prepared, packed or held under insanitary conditions [Adulteration, 402(a)(4)]."