IA #16-02, 5/21/96 REVISED, ATTACHMENT REVISED 2/4/04 SUBJECT: ***Detention of All Dried Shark Fins, Dried Fish Maws and Shark Cartilage Powder Without Physical Examination*** Note: This alert is being revised to provide changes to format and/or terminology and are bracketed by asterisks (***). TYPE OF ALERT: ***Detention Without Physical Examination*** ***(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 regulated entities.)*** PRODUCT: Dried Shark Fins (All types, e.g., whole, shredded, cakes) Dried Fish Maws Dried Shark Cartilage Powder (utilizing dried shark fins/ maws as the source material) PROBLEM: Insect (FLNF), rodent (FLRF), and/or other animal filth (FLAF) PRODUCT CODE: 16Y-H08 Shark Fins 16Y-H07 Fish Maws 54G--04 Shark cartilage powder PAC FOR COLLECTION: 03844 COUNTRY: All (999) PROCESSOR OR SHIPPER: All, except those listed on the attachment. PROCESSOR OR SHIPPER I.D.#: See Attachment IMPORTER'S I.D. #: N/A 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, (insect, rodent, and/or other animal filth), or to be otherwise unfit for food [Adulteration, Section 402(a)(3)]." RECOMMENDING OFFICE: Division of Import Operations & Policy, HFC-170 ORL-DO, HFR-SE240 NYK-DO, HFR-NE152 SAN-DO, HFR-PA152 REASON FOR ALERT: Insect, rodent or other animal filth has long been a problem with dried shark fins of all types and dried fish maws. The FY-93 national detention data identified over 160 detentions from more than 20 countries. IA#16-02 REVISED 05/21/96 PAGE 2 This import alert replaces Import Alert #16-01 "Automatic Detention of Sharkfins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products is the same, and criteria for ***detention without physical examination*** have been met. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis. GUIDANCE: ***Districts may detain all dried shark fins, all dried fish maws, and dried shark cartilage powder derived from shark fins/maws without physical examination.*** An attachment for firms exempt from ***detention without physical examinatin*** will be issued as necessary. METHODOLOGY: Dried shark fins (all types, e.g., whole, shredded, cakes) dried fish maws, and shark cartilage powder shall be examined according to the procedures outlined in LIB 2957, Examination of Dried Fish for Microscopic Filth. PRIORITIZATION GUIDANCE: III FOI: No purging of this alert is required. KEYWORDS: Dried Shark fins, sharkfins, dried fish maws, seafood, shark fin cake, shredded shark fin, dried, shark cartilage, powder PREPARED BY: Linda A. Wisniowski, DIOP, 301-443-6553. ATTACHMENT TO IA #16-02 2/4/04 THE LIST OF FIRMS THAT ARE EXEMPT FROM AUTOMATIC DETENTION Aroma N. Z. Limited 8/29/94 P.O. Box 2683 Shark Cartilage Christchurch New Zealand MID #NZARONZ2683CHR Comexa Ltda. 1/2/96 Via Mamonal Sector Shark Cartilage Albornoz 25-196 Cartagena de Indlas Colombia, A.A. 15100 MID# COCOMLTD2519LTD Corporacion Nacional De Ventas, S.A. 2/2/96 Insurgentes Sur 605-505 Col Shark Cartilage Napoles C.P. 03810 Mexico, D.F. MID# MXCORNAC6055NAP MID# MXCORNA605MEX Corporacion Procesadora 7/26/95 de Cartilago, S.A. Shark Cartilage Apartado Postal 86-5400 Barranco, Puntarenas, Costa Rica MID# CRCORPRO8654PUN Cottee Dairy Products PTY LTD Shark cartilage powder Level 2, 25 Merriwa Street 54G[][]04 - 5/2/97 Gordon, NSW Australia 2072 Name change 4/7/98 FEI# 3001152739 Cottee Health PTY Limited Shark Cartilage Powder 15B Rodborough Road 54G04 French's Forest, NSW 2086 11/19/99 Australia FEI# 3002693988 CV Technologies, Inc Shark Cartilage 9411 - 20 Avenue 6/4/96 Research Centre One Edmonton, Alberta Name and Address Change(HerbTech) T6N1E5 Canada 10/7/02 FEI #3003144341 Dingtao Sun Biochemical Factory Chondroitin Sulfate You Ji, Fangshan Village (marine origin) Dingtao County 12/ /02 Shandong Province, China FEI # 3003527951 Gaveteco S.A. Ind. Shark Cartilage Powder/ Com. Fin. E Inm. 54G--04 Av. Belgrano 1281 3/12/97 Buenos Aires Argentina FEI# 1000403696 MID# ARGAVSA1281BUE Jose Jorge Peralta Pena 7/20/00 343 Rayon Shark Cartilage Ensenada, B.C., Mexico FEI #1000209507 Name Change (Gilberto Carlos Arce Tubillo) 8/14/03 Kenko Commerce & Company 5/13/97 2-11, Uchikanda 3-Chome Shark Cartilage Powder Chiyoda-Ku, aka Sodium Chondroitin Sulfate Tokyo, Japan 54G04 FEI# 1000109810 MID# JPKENCOM211TOK Lane Labs Pty. Ltd. 6/1/95 36 Central Drive, (Address corrected Andrews, 2/17/98) Brisbane, Australia Shark Cartilage/Powder MID# AULANLAB36BRI FEI# 1000273153 Maruha Corporation (Headqtrs) (formerly Taiyo Fisheries, Ltd.) 1-2, 1-Chome Otemachi, Chiyoda-Ku Tokyo, Japan MID # JPMARCOR121TOK FEI # 1000272260 Maruha Corporation/Utsunomiya (Factory) Shark Cartilage Concentrate 8-5, Kiyohara-Kogyodanchi, (aka "sodium chondroitin sulfate" Utsunomiya-City, Tochigi-Prefecture, 10/23/95 321-32, Japan MID # JPMARCOR85UTS FEI # 1000181676 Natural Factors Nutritional Products Ltd. Shark cartilage powder 1550 United Boulevard 54G[][]04 Coquitlam, B.C., Canada V3K 6Y7 7/28/03 FEI #3003235214 ProBiotec P.T.Y. Ltd. Shark Cartilage Powder 68 O'Grady Drive 54G--04 Paradise Point, Australia 10/18/02 FEI #3003428419 PT Eksindo Jaya Terang Mustika Shark Cartilage Jl Pisangan Lama 1/7 3/6/96 Jakarta, Indonesia MID# IDPTEKS17JAK Seikagaku Corporation Shark Cartilage Tokyo Yakugyo Bldg 54G04 1-5, Nihonbashi-Honcho 2-chome 11/4/97 Chuo-ku, Tokyo 103 Japan FEI# 1000417771 Shark Line Exports Shark Cartilage/Bones Industral Nagar 54G07 Kerala, India 10/9/97 FEI# 1000442310 Sinotrans G/D Im/Ex Trading Co. Shark Cartilage 1125 Guang Yuan Rd. C 2/2/96 Guangzhou, China MID# CNSINTRA1125GUA Yantai Tsi Nutritional Shark Cartilage Concentrate Products Co., Ltd. (AKA Sodium Chondroitin Sulfate) Yanqing Road 54G[][]04 Industrial Zone 54G[][]99 Laiyang, Shandong 265200 2/4/04 China FEI# 3003679369