IA #16-100, REVISED 6/4/96 - ATTACHMENT REVISED 8/12/94 SUBJECT: ***Detention Without Physical Examination of Langostinos Due to the Presence of Staphylococcus Aureus and E. Coli/ Coliforms*** NOTE: This alert is being revised to provide changes to format/ terminology and are bracketed by asterisks (***). ***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.*** TYPE OF ALERT: ***Detention Without Physical Examination*** PRODUCT : Frozen Langostinos PRODUCT CODE : 16J--05 PROBLEM : Staphylococcus Aureus (FLST) E. coli/coliforms (FLEC) PAC FOR COLLECTION : 03844 COUNTRY : See Attachment MANUFACTURER/ SHIPPER : See Attachment MANUFACTURER/ SHIPPER I.D.#: See Attachment IMPORTER'S I.D. # : N/A CHARGE : For Staphylococcus aureus and/or E. coli/coliforms, charge: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, by reason of presence therein of Staphylococcus aureus and/or E. coli/coliforms, or to be otherwise unfit for food [Adulteration, Section 402(a)(3)]." RECOMMENDING OFFICE : Import Branch, ***New England District***, HFR-NE150 REASON FOR ALERT : Problems involving Staphylococcus aureus and E. coli/coliforms continue to be found by FDA in samples of langostinos from Chile. Firms listed in the Attachment to this alert have met the criteria for ***detention without physical examination***. METHODOLOGY : Staph aureus - BAM, 7th Edition 1992, Chapter 12, Most Probable Number (MPN) method A-D * E E. coli/coliforms - BAM, 7th Edition 192, Chapter 4 - C, D, F1 Aerobic Plate Count (APC) - BAM, 7th Edition 1992, Chapter 3 - A, B C1, D GUIDANCE : ***Districts may detain, without physical examination*** all frozen langostinos from the firms listed on the attachment. Surveillance for presence of microbiological contamination of langostinos from other firms appears warranted. PRIORITIZATION GUIDANCE : I FOI : No purging is required KEYWORDS : Langostinos, Lobsters, Staphylococcus aureus, E. coli, coliform, bacteria PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553. Attachment - Import Alert #16-100 Revised 8/12/94 FIRMS UNDER DETENTION WITHOUT PHYSICAL EXAMINATION CHILE (CL 275) FIRM NAME & ADDRESS AUTOMATIC DETENTION DATE Pesquera Santa Lucia S.A. 8/16/93 Camina Publico Quintero S/M Casiffa 131 Quintero, Chile MID #CLPESSANQUI