IA#16-13 - 6/5/96, REVISED, ATTACHMENT - 4/27/92 SUBJECT : "***Detention Without Physical Examination*** of Anchovy or Bagoong Products from Philippines" - TYPE OF ALERT : ***Detention Without Physical Examination*** Note: this alert is being revised to provide changes to format and/or terminology and are bracketed by asterisks (***). ***(Note: This import alert contains guidance to FDA field personnel only. It does not establish any requirement, or create any rights or obligations on FDA or on regulated entities.)*** PRODUCT : a. Anchovies b. Bagoong, a sauce made from anchovies or small fish which have been salted and fermented or products from Bagoong. PRODUCT CODE : 16A--01 PROBLEM : Filth (FLNF, Insert; FLRF-Rodent) E. Coli, Coliforms (FLEC) COUNTRY : Philippines (PH,725) MANUFACTURER/ SHIPPER : N/A MANUFACTURER SHIPPER I.D.# : N/A IMPORTER'S I.D.# : N/A CHARGE : For Filth, 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 or is otherwise unfit for food, in that it contains insect, rodent, animal or other filth" [Adulteration, Section 402(a)(3)]. For presence of E. Coli/Coliforms, Charge: "This 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, or is otherwise unfit for food in that it contains E.Coli/Coliforms" [Adulteration, Section 402(a)(3)]. RECOMMENDING OFFICE : Division of Import Operations and Policy, HFC-170 REASON FOR ALERT : During the six month period from November 16, 1982, through May 18, 1983, 12 out of 18 lots of anchovy products sampled and examined for filth were detained (a 67% violation rate). Ten detentions were for insect and/or rodent filth and two detentions were for E. Coli and Coliforms. Product detained included salted anchovies, anchovy sauce (bagoong), dried anchovies, and frozen anchovies. Dual declaration of the products which are subject to this action are bagoong monamon-dilis, dilis- monamon, and bagoong mabgas dilis. Review of FY 91 detention data indicates that 41 detentions of these products were made. Further review indicated that the majority were refused due to lack of private laboratory analyses, requested refusals and physical analyses showing presence of filth. Of 8 samples collected and analyzed 15 (63%) were violative. No detentions were noted for presence of E. Coli. GUIDANCE : When entries declared as bagoong, bagoong manomon-dilis, dilis-monamon, and bagoong mabgas dilis are encountered they should be checked to determine if they are anchovy products. ***Districts may detain, without physical examination***, all anchovy products from the Philippines except the packers/products identified on the attachment to this Import Alert. When examining audit samples from entries that have been found acceptable by private laboratory results, in addition to an examination for filth, analyze for E. Coli and coliforms. ***For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007.*** PRIORITIZATION/ GUIDANCE : III FOI : Bagoong, Anchovy, Dilis, Monamon, Filth, Coliforms. E. Coli KEYWORDS : No purging required PREPARED BY : Linda A. Wisniowski, DIOP, (301 )443-6553 ATTACHMENT- IMPORT ALERT #16-13 4/27/92 PACKER/PRODUCTS EXCLUDED FROM DETENTION WITHOUT PHYSICAL EXAMINATION 1. Ayala Corporation Fish (Patis) Sauce Makati, Metro Manila Philippines 2. Rufina Patis Factory Fish (Patis) Sauce Manila, Philippines