IA #25-02 - 9/19/96, REVISION OF IMPORT ALERT #25-02, "**DETENTION WITHOUT PHYSICAL EXAMINATION** OF MOREL MUSHROOMS DUE TO ADULTERATION AND SUBSTITUTION", ATTACHMENT A - 9/19/96 NOTE: This import alert is being revised to update the format and to create an attachment. TYPE OF ALERT : Detention Without Physical Examination and Increased Surveillance (NOTE: This import alert contains guidance to FDA field personnel only. It does not establish any requirements, or create any rights or obligations on FDA or on regulated entities.) PRODUCT : ** All morel and false morel mushrooms (fresh, canned and dried) May be labeled as: - morels, or morille mushroom (Morchella esculenta) - black morels (Morchella conica) - pointed morels (Morchella angusticeps) - false morels or round morels gyromitres (Gyromitra esculenta)** PRODUCT CODE : ** 25 P[] A 06 25 P[] E 06 25 P[] H 06 ** PROBLEM : ** Adulteration due to toxic substances: - Gyromitra esculenta: Gyromitrin toxin- causes monomethylhydrazine poisoning; - Verpa bohemica: Unidentified toxin similar to gyromitrin - produces gastrointestinal and neurological effects in some individuals;** and - Substitution with toxic mushrooms (as identified above) PAC FOR COLLECTION : ** 07F800 ** PAF : FDQ COUNTRY : ** France (FR, 350)** MANUFACTURER/ SHIPPER : See Attachment MANUFACTURER/ SHIPPER'S ID# : See Attachment CHARGE : ** Presence of Gyromitrin and similar hydrazine derivatives. ** "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to ** bear or contain mushroom toxins, a poisonous and deleterious substance which may render it injurious to health [Adulteration, Section 402(a)(1)]; and it appears to bear or contain species of mushroom other than morels but its labeling fails to reveal the presence of a species of mushroom other than morels ** [Misbranding, Section 403(a)(1)]." RECOMMENDING OFFICE : ** ATL-DO (HFR-SE150), BLT-DO (HFR-MA270) and DIOP (HFC-170) ** REASON FOR ALERT: ** In the past, shipments of canned and dried morel mushrooms have been detained due to the presence of Gyromitra esculenta. This mushroom species is known to produce monomethylhydrazine (MMH), a substance which causes severe gastrointestinal disturbance and, in some cases, death. In addition to Gyromitra esculenta, CFSAN has identified another species, Verpa bohemica, which can also cause toxic effects in some individuals. ** GUIDANCE : ** Districts may detain without physical sampling and analysis, any shipments of fresh, dried, or canned morel mushrooms from those manufacturers and/or shippers listed on the attachment to this alert. Increased surveillance of fresh, dried, and canned morel mushrooms from other firms and countries appears to be warranted. Questions regarding products or sampling should be directed to John Gecan at (202) 205-4513. Samples should be sent to CFSAN, Division of Microanalytical Evaluations, HFS-315, ATTN: John S. Gecan/Stanley M. Cichowicz for specific identification. Mark packages: "DO NOT SEND TO SAMPLE ROOM."** PRIORITIZATION GUIDANCE : I FOI : No purging required. KEYWORDS : Morel, Mushrooms, Gyromitra esculenta, Verpa bohemica PREPARED BY : Ivette Aguirre-Flores and Alwin Collins, DIOP (HFC-170) (301) 443-6553. DATE LOADED INTO FIARS : September 19, 1996 Attachment A - 9/19/96 Detain without physical sampling and analysis, all shipments of fresh, dried, or canned morel mushrooms from the firms listed on this attachment. FRANCE FIRM Plantin S.A. 84110 Vaison La Romaine Puymeras, France MID #FRPLA4110LAR FEI #1000230157 ETS. G. Borde B.P. 4 43170 Saugues, France MID #FRETSBOR4431PAR FEI #1000192787