IA #16-05, Revised 5/7/98, Attch. A, Revised 9/28/04, Attch B, 10/21/04 SUBJ: "REVISION TO IMPORT ALERT #16-05 "DETENTION WITHOUT PHYSICAL EXAMINATION OF MAHIMAHI BECAUSE OF HISTAMINE AND DECOMPOSITION 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 and intensified coverage (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: Mahimahi (dolphin) raw, fresh or frozen, including fillets PRODUCT CODE: 16A--51 PROBLEM: Decomposition, Histamines (FLHS, MSDC) PAC: 03844 COUNTRY: Detention Without - Ecuador (EC, 325) Physical Examination - Taiwan (Tw, 281) Intensified Coverage - All, except Japan (ZZ,999) MANUFACTURER/ SHIPPER: *** All shippers from Taiwan and Ecuador except those listed on Attachment A. Shippers on Attachment B*** MANUFACTURER/ SHIPPER I.D.#: N/A CHARGE: "The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to bear or contain Histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health [Adulteration, Section 402(a)(1)] and/or 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 appears to be decomposed [Adulteration, Section 402(a)(3)]." RECOMMENDING OFFICE: Division of Import Operations and Policy (HFC-170) and CFSAN/Division of Field Program Planning and Evaluation (HFS-635) REASON FOR ALERT: In March 1980, the Center for Disease Control reported that mahimahi (dolphin fish) accounted for 40% of the scombroid poisoning outbreaks reported in the United States. Also, during March 1980, FDA received reports of 10 separate scombroid poisoning incidents involving about 70 people. As a result, on April 28, 1980, the districts were instructed to sample and analyze, for histamine, 100% of all shipments of mahimahi offered for entry from all countries. On July 8, 1980, the districts reported that they sampled and analyzed 73 shipments of mahimahi from China, Ecuador, Peru, and Taiwan. From this data, it was determined that mahimahi from Ecuador and Taiwan met the criteria for detention without physical examination. In the latter part of FY 80, LOS-DO organoleptically detected decomposition in 11 of 24 Ecuador/Taiwan mahimahi samples (46%). Mahimahi may be decomposed without toxicologically significant levels of histamine. Thus, all district import personnel must be alert to the possibility of significant decomposition problems in mahimahi, even when toxicologically significant histamine levels are not noted. Odors of spoilage are not necessarily found in the same part of fish where histamine is found. Sample results on mahimahi entering from Japan have not indicated problems with histamines and decomposition. Recent sample results as well as a number of reported illnesses attributed to imported mahimahi indicate continuing problems with histamines and decomposition in mahimahi from Ecuador. GUIDANCE: Histamine: Districts may detain without physical examination all shipments of mahimahi from Ecuador and Taiwan, except those packers *** identified on attachment A *** to this alert. *** Attachment "B" contains individual shippers on detention without physical examination from countries other than Ecuador or Taiwan *** Continue intensified coverage of all shipments of mahimahi from all other countries except Japan. Districts may sample Japanese mahimahi at their own discretion. Note: Mahimahi from packers identified as exempt from detention without physical examination should be periodically audit sampled and analyzed for histamines. METHODOLOGY: See Import Seafood Products Compliance Program, 7303.844. PRIORITIZATION GUIDANCE: II FOI: No purging necessary. KEYWORDS: Mahimahi, Mahi Mahi, Dolphin Fish, Histamine, Decomposition, Dorado PREPARED BY: Jack Geltman, DIOP, 301-443-6553. Attachment ***A*** to Import Alert #16-05, Revised 9/28/04 EXEMPT MANUFACTURERS/SHIPPERS FROM ECUADOR & TAIWAN Agrol S.A. 9/5/97 Calle 25, Avenida M-3 Manta, Manabi Ecuador FEI# 1000496181 Alba Pino Leon 6/21/94 Salinas, Ecuador Ammon International, Inc. Mahi Mahi 2F-2, NO. 12, Tien-Mu 16A--51 West Road 9/17/04 Shih Lin District Taipei, Taiwan, R.O.C. FEI #3000239551 Bajespec S.A. 3/7/94 MZ, No. 1, Solar No. 3 CALLE 7ma. Y CALLE A Guayaquil, Ecuador MID# ECBAJCAA1141GUA Boris Buenaventura Trujillo 3/26/91 Manta, Ecuador Brimon S.A. Mahi Mahi Mapasingue Oeste Ave Iere 2/20/01 Guayaquil, Ecuador FEI# 3002804141 Cepromar a/k/a Corporacion Ecuatorian de Productos del Mar S.A. Guayaquil, Ecuador Chia Fong Frozen Food Co., Ltd 7/31/98 28 Fishing Harbor Road P.O. Box 1719 Kaohsiung, Taiwan FEI# 1000430969 Chun Success International Co. 08/22/01 7F, No. 63, Tien-Hou Street Chien Chen District Kaohsiung, Taiwan R.O.C. FEI# 3003041368 Chupamar Guayaquil, Ecuador Comercial Santana (Cosace) Ecuador Conservas Marinas, S.A. Esmeraldas, Ecuador Costapesca 12/05/95 (Formerly Known As: Eduardo E. Calderon Z.) Av. Colon #535, Piso 8, (NAME CHANGE Oficina #804 ONLY 2/13/96) Quito, Ecuador MID# ECEDUCAL535QUI ECCOS535QUI Criaderos Acuatoico La Guita 5/10/96 EDIF. Torre Azul Piso 11 Guayaquil, Ecuador MID# ECCRIACU11GUA Docapes Mahimahi Pescados Camarones Mariscos S.A. 16A--51 C.C. El Terminal Bloque F 6/4/04 Local No. 4 Guayaquil, Ecuador FEI# 3001342367 * Ecuafish S.A. 8/29/02 3 2 Via Manta-Montecristi Manta, Ecuador FEI# 3001027795 * Name change formerly known as Fresmar Cia. Ltda Ecuafresco S.A. 6/16/93 Manta, Ecuador (correct address) Ecuamar S.A. 6/14/91 Calle 6 Guayaquil, Ecuador El Rosario (ERSA) S.A. Mahi Mahi/16A[][]51 Av. Mons. D. Com¡n y 1/11/01 P.J. Bolo¤a Guayaquil, Ecuador FEI# 1000156451 Empacadora Bilbo, S.A. 7/6/95 AKA:BILBOSA Carretera Manta - Montecristi KM 7 Montecristi Ecuador MID# ECEMPBIL7MAN ECEMPBILMAN ECEMPBILMON Empacadora Diamante 7/22/02 Av. Eloy Alfaro SN Y Juncos Esmeraldas, Ecuador FEI# 3003528736 Emcopac S.A. 3/5/91 (Empacadora Coral de Pacifico) Manuela Canizares 202 y Sucre (ADDRESS CHANGE) Esmeralda, Ecuador 4/30/04 FEI# 3004316297 Escualem Cia. Ltda Fresh Mahi Mahi Bolivia 1600 Y Ave 16A-B51 Del Ejercito 16A-C51 Guayaquil, Ecuador 16A-D51 FEI# 3004059370 10/20/03 Ever Hope International Co., Ltd. 4/7/98 No. 50 Lane 84, Kuo Bei Road Feng San City Taiwan FEI# 3000972683 Ever Spring Foods Supplier Inc. 9/8/04 No. 27 Yu-Kangs 1st rd. Chien Jenn Dist. Kaohsiung, Taiwan R.O.C. FEI# 12975 Exportadora Del Oceano Pacifico 3/9/95 aka: OCEANPAC KM. 7 1/2 via A Daule Guayaquil, Ecuador MID# ECEXPDEL712GUA Exportadora Gamex 11/29/91 Apartado de Correos No. 2764 Corretero Monta Montecristi, Ecuador Exportadora Hantamar S.A. Mahi-Mahi Villamil 210 y Calderon 16A--51 Guayaquil, Ecuador 5/23/01 FEI# 3002736567 Exportadora Yifar Express Sudamerica 2/14/92 S.A. Empacadora:Km. 11 1/2 Via a Daule Guayaquil, Ecuador Fishcorp S.A. Mahimahi Km 42 Via Manta Rocafuerte 4/17/00 Manta Ecuador FEI# 3002704341 Fortumar Ecuador S. A. 2/24/92 Guayaquil, Ecuador Fresh Fish del Ecuador Mahi Mahi Km 4 1/2 Via Manta San Mateo 2/21/01 Manta, Ecuador FEI# 3003164547 Frigolab San Mateo Cia Ltda. 9/7/93 Manta, Ecuador MID# ECFRISANMAN Frigolandia S.A. 12/10/97 Km. 9 1/2 Via Daule Guayaquil Ecuador FEI# 1000476279 Frigorificos Acuario S.A. (FRACUSA) Guayaquil, Ecuador Frigorificos Y Frutas Tropicales Frutrosa S.A. (a/k/a FRUTROSA) Guayaquil, Ecuador Frimar (Frio Y Mariscos) Guayaquil, Ecuador Frumaco S.A. 4/4/91 Avenida Juan Tanca y Marenco Guayaquil, Ecuador Gallant Seafoods Corporation Mahi Mahi/16A--51 23 Fishing Harbor S. 1st Road 10/7/03 Kaohsiung, Taiwan, R.O.C. FEI# 3003884764 Gondi Cia. Ltda 5/31/95 P.O. Box 13-05-4761 Manta, Ecuador MID# ECGONCIA1305MAN Good Fish 5/31/01 La Pulida 157 Quito, Ecuador FEI# 3003160292 Grumodu's 7/22/93 Avenida Primera No. 107 Mapasinque Guayaquil, Ecuador ID# ECGRU107GUA Henmur S.A. 7/21/98 Ave. 23/121/Y Calle 12 Manta, Ecuador FEI# 3001139454 Hochico Marine Processing Corp. 9/28/01 29 Der Shin 1st Road Su-Ao, I-Lan Taiwan FEI# 3002808707 Hung Lou International Trading Co. Kaohsiung, Taiwan Hsien Pin Frozen Foods, Co., Ltd. 12/10/93 21 Pzyh Chyang Road Su-Ao Chen, I-Lan HS Taiwan R.O.C. MID# TWHSIPIN21SUA I-Mei Frozen Foods Co., Ltd 9/23/99 No. 244 Fu Der Road, Su-Ao I-Lan, Taiwan FEI# 1000152505 Industria Exportadora del Pacifico Cia Ltda 12/5/00 Km 6 1/2 Via Juan Tanca Marengo Frente Colegio Americano Guayaquil, Ecuador FEI# 1000295122 Industrial Pesquera Monteverde C.A. 6/14/91 (INPECA) Guayaquil, Ecuador Industries Del Mar Lubar Ecuador Julieta Mera Capitan Merjera Guayaquil, Ecuador Mardex Cia. Ltda. 3/7/94 Avenida 102 Los Esteros P.O. Box 3894 Manta, Ecuador MID# ECMARCA3894MAN Mardelit Cia. Ltda. 4/8/99 Avenida M-3, Calle 25 Manta, Ecuador FEI# 1000453705 Mariscos (Marcrusa) Y. Crustaceos S. A., Guayaquil, Ecuador Negocios Industriales Real S.A. 4/15/91 Guayaquil, Ecuador Neptuna CIA. LTDA Apartado Postal 352 Guayaquil, Ecuador Ocean Beauty Corp. Frozen Mahi Mahi/16A--51 Room 16, 6th Floor 02/11/04 No. 1, section 3 Shin Sheng North Road Taiwan, Republic of China FEI# 3000325913 Oceanfish S.A. 2/20/96 Km. 4.5. Via Manta-Montecristi Manta, Ecuador Address Change 3/13/01 FEI# 3004347364 Name Change 5/10/04 Ocean Majesty, Inc. Taipei, Taiwan Paexport S.A. 2/28/91 Guayaquil, Ecuador Patricio Villamar 5/20/99 Agroseafod S.A. Calle 3ra. No. 401 y Av Miraflores, Guayaquil Ecuador FEI# 3002625582 Pefresco Mar CIA Ltd. 10/9/97 Avenida Flavio Reyes Y Calle 27 Manta, Ecuador FEI# 3000280668 Pefresman Cia, Ltda. 5/6/91 Calle 113 Avenida 103 Manta, Ecuador Pesca Ecuatoriana Cia Ltda. 6/10/93 Edificio El Vigia M-109 Apartado Postal No. 13-05-3817 Manta, Ecuador ID# ECPESECU1305MAN Pesnusan CIA, Ltda. 4/18/00 Km 7.5 Via Manta Montecristi Manta, Ecuador FEI# 1000360294 Pesquera Progalca C.A. 7/18/00 Mapasingque Oeste Ave Jra. Nr.324 Entre Guayaquil, Ecuador FEI# 3000983518 Phillips Seafood of Ecuador, C.A. 7/25/01 Km. 9.5 Via a Daule Guayaquil. Ecuador FEI# 3001219367 Promarpasa Productos del Mar Patico's, S.A. Guayaquil, Ecuador Promarosa Cia Ltda (Productos del Mar Santa Rosa Cia Ltda) Guayaquil, Ecuador Rader S.A. 12/08/94 95 Via Daule P.O. Box 09014934 Guayaquil Ecuador MID# ECRADSA95GUA Sandra Ronquillo Perez 5/31/96 Calle 61 Y Ave 49 Guayaquil, Ecuador MID# ECSANRON61GUA * Sea Taste Foods Corporation 6/3/92 No. 26 Jong Heng Street Hsiao Kang District Kaohsiung, Taiwan, Republic of China *Name Change formerly Ho Kee Frozen Foods Foods Factory 7/21/98 Shianlin Frozen Foods Processing Address changed Plant Co., Ltd. 5/23/95 90 7F Chien Kuo, 1st Road Kaohsiung, Taiwan MID# TWSHIFRO90KAO Shin Evergreen Marine Products Co., Ltd. 9/28/04 1F, No. 47-39, Singdong Rd., Donggang Township Pingtung, Taiwan FEI# 3004688009 Super Fresco Seafood 10/18/01 Ave de Lo Motiones Lote 25 Quito, Ecuador FEI# 3003189833 Tong Yeng Industrial Co. Ltd. Tong-Sang, l-Lan, Taiwan Transmarina C.A. Induato 905 Guayaquil, Ecuador Trife F Fresh Fishes Finest S.A. 9/19/00 Cdia Nva Kennedy Norte Mz #4 Solar 91 er Guayaquil Ecuador FEI# 3003002236 Union Development Frozen 2/5/02 Foods Co., Ltd. 5 Tong Lin Road Hsiao Fang District Kaohsiung Taiwan, Republic of China FEI# 1000145404 FACTORY LOCATION: Yelin Enterprise Co., Ltd. 4/9/98 # 100 Chen Shin Village Wu Gie District I-Lan, Taiwan FEI# 3001446720 OFFICE LOCATION: Yelin Enterprise Co., Ltd. 4/9/98 6th Floor No.70 Min Chuan West Road Taipei, Taiwan FEI# 1000262767 *** Attachment B - Import Alert #16-05 10/21/04 SHIPPERS ON DETENTION WITHOUT PHYSICAL EXAMINATION FROM COUNTRIES OTHER THAN ECUADOR OR TAIWAN *** Hai Vuong Co., Ltd. Mahimahi Decomposition Suoi Dau Industrial Zone 16A--51 & Khanh Hoa Province Histamines Vietnam 8/5/04 FEI# 3004277224 Highland Dragon Enterprise Fresh, Fresh Frozen Histamines # 15 Road 6 Mahi Mahi and Decomp Song Than 1 Industrial Park 16A--51 Binh Duong Province 10/9/02 Vietnam FEI# 3003467708 Nha Trang Seafoods-Factory 90 Mahi Mahi Decomposition 1 Phuoc Long, Binh Tan 16A[][]51 Nha Trang, Vietnam 9/17/04 FEI# 3004263028 P.T. Mirta Raya Mina Frozen Mahi Mahi Fillets Histamines & Muara Baru Blok B, 18 16A51 Decomp Jakarta, 14440, Indonesia 5/7/98 FEI# 3001245130