IA #16-119 - 12/19/97, ATTACH A - 8/26/04 SUBJECT: "DETENTION WITHOUT PHYSICAL EXAMINATION OF FISH AND FISHERY PRODUCTS FOR IMPORTER AND FOREIGN PROCESSOR (MANUF) COMBINATIONS" TYPE OF ALERT: Detention without Physical Examination Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the verification requirements of the seafood HACCP program. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.) PRODUCT: Fish and fishery products (See Attachment A for specific firm(s)/product(s) combinations) PRODUCT CODE: See Attachment A PROBLEM: Failure of importer to provide verification per 21 CFR 123.12(d) that fish and fishery products have been processed under conditions that comply with requirements of 21 CFR 123, "Fish and Fishery Products". PAC FOR COLLECTION: 03844 - Foodborne Biological Hazards 07844 - Natural Toxins 09844E - Color Additives 09844F - Food Additives PAF: REG COUNTRY: See Attachment A IMPORTER/ MANUFACTURER/ SHIPPER: See Attachment A For compliance with 21 CFR 123.12, "Special Requirements for Imported Products", the term "importer" is defined by 21 CFR 123.3(g) as "...either the U.S. owner or consignee at the time of entry into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that the goods being offered for entry into the United States are in compliance with all laws affecting the importation. For the purposes of this definition, ordinarily the importer is not the custom house broker, the freight forwarder, the carrier, or the steamship representative." NOTE: The definition of "importer" for the purpose of enforcing 21 CFR 123.12 is significantly different from the definition traditionally used for U.S. Customs purposes. The importer will usually be the consignee of the product. IMPORTER/ MANUFACTURER/ SHIPPER FEI#: See Attachment A CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d) [Adulteration, 402(a)(4)]." (OASIS Charge Code - IMPTRHACCP) RECOMMENDING OFFICE: Division of Import Operations and Policy HFC-170 and CFSAN, Office of Seafood REASON FOR ALERT: On December 18, 1997, 21 CFR Part 123, "Fish and Fishery Products" becomes effective. This regulation provides special requirements for imported products under 21 CFR 123.12. Importers who import fish or fishery products and fail to meet these requirements may have their entries subject to detention without physical examination until such time as verification of compliance by the importer is provided, as noted in the "GUIDANCE" section of this import alert. GUIDANCE: Districts may detain, without physical sampling and analysis, firms/fish and fishery product(s) combinations as noted on Attachment A of this import alert. (Note: Districts should refer to compliance program 7303.844 "Import Seafood Products" for implementation guidance.) Districts should be aware that for inclusion to or removal from detention without physical examination of importers/products/foreign processor combinations listed on Attachment A, the following procedures apply: When the district has determined that the importer has failed to meet HACCP verification requirements for a specific product and foreign processor (manufacturer), the district may recommend that the specific importer/product/foreign processor (manufacturer) combination be subject to detention without physical examination and included on Attachment A. Importers may be listed for particular products and foreign processors (manufacturers) associated with that importer, or importers may be listed for all products and all foreign processors associated with that importer. (Note: At this time, Attachment A only includes information for illustrative purposes.) A foreign processor's (manufacturer's) product may be detained without physical examination when the importer and the particular product(s) being imported are identified on Attachment A. Note that importers not listed on Attachment A, who may receive a foreign processor's (manufacturer's) product listed next to an importer that is listed on Attachment A, would not have their imported products detained unless it is determined to be subject to other directives or found to be violative based on district examination. If it becomes apparent that an importer has no verification procedures for any imported fish or fishery products, all such products from all processors (manufacturers) imported by that importer may be subject to detention without physical examination. The importer may then be placed on Attachment A for all fish and fishery products from all foreign processors (manufacturers). Importers listed on Attachment A may be removed from the list by submitting verification per 21 CFR 123.12(d) that the fish or fishery product(s) in question has/have been processed in compliance with the seafood HACCP regulation (21 CFR part 123), and that appropriate verification of such processing is maintained by the importer. When districts determine that satisfactory verification has been provided by the importer, districts may recommend to DIOP that the importer/ product/ processor (manufacturer) be removed from Attachment A. (Note: Attachment A will be updated as importer/product/foreign processor combinations are either added or removed from detention without physical examination.) Citing 21 CFR 123.12 (a) (Importer Verification), every importer of fish and fishery products shall either: . Have and implement written verification procedures for ensuring that the fish and fishery products that they offer for import into the United States were processed in accordance with the requirements of 21 CFR Part 123; verify product specifications that are designed to ensure that the product is not adulterated under Section 402 of the Federal Food Drug & Cosmetic Act; and verify affirmative steps which may include any of the following: . Obtaining from the foreign processor the HACCP and sanitation monitoring records required by 21 CFR 123 that relate to the specific lot of fish or fishery products offered for import; . Obtaining either a continuing or lot-by-lot certification from an appropriate foreign government inspection authority or a third party, certifying that the imported fish or fishery product is or was processed in accordance with the requirements of 21 CFR 123; . Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of 21 CFR 123; . Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee (in English) from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of 21 CFR 123; . Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with 21 CFR 123; . Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of 21 CFR 123.12; OR, II. Hire a competent third party to assist with or perform any or all of the verification activities as specified in 21 CFR 123.12(a)(2), including writing the importer's verification procedures on behalf of the importer. Further, 21 CFR 123.12(c) states that the importer shall maintain records, in English, that document the performance and results of the affirmation steps specified in 21 CFR 123(a)(2)(ii). NOTE: Importers who obtain fish and fishery products from a country that has an active Memorandum of Understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the fish and fishery product and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the current situation between the signing parties, and is functioning and enforceable in its entirety, are not required to provide verification as in 21 CFR 123(a)(2)(i) and (ii). As seafood HACCP MOUs or similar agreements with foreign governments are established, a list of these MOUs will be included in Attachment B to this import alert. For questions regarding importer verification procedures, contact: The Seafood HACCP Team at telephone number: 202-418-3150, or by FAX at: 202-418-3196. OASIS CHARGE CODE: IMPTRHACCP PRIORITIZATION GUIDANCE: I FOI: No purging is required KEYWORDS: HACCP, verification, fish, fishery product, seafood PREPARED BY: DIOP, HACCP Working Group (Linda Wisniowski and Doug Randes), 301-443-6553, CFSAN, OFP, (Frank Sikorsky, 202-205-1922) DATE LOADED INTO FIARS: May 15, 2001 ATTACHMENT A 8/26/04 DETENTION WITHOUT PHYSICAL EXAMINATION FOR SPECIFIED COMBINATIONS OF IMPORTERS, FISH/FISHERY PRODUCTS, and FOREIGN PROCESSOR/ MANUFACTURERS IMPORTER PRODUCT CODE / FOREIGN PROCESSOR NAME AND ADDRESS: PRODUCT: NAME AND ADDRESS: DATE DWPE: Asian American Trading All fish/fishery products All Co., Inc. 16[][][][][] 5th Street, Building A 5/13/03 Mercado Centeral, Zona Portuaria Puerto Nuevo, PR 00920 FEI# 1000444861 Fish and Fishery Products including: Charm Han Enterprise Inc. Dried Fish:(anchovies,cuttle fish ALL 3071 E 12th Street octopus,squid,anchovy powder, Los Angeles, CA. 90023-3613 fish roe) Seasoned Fish:(anchovies FEI# 3003030599 swimming crab,squid,Pollack roe, shad entrail,octopus,hairtail croaker,cuttlefish,cod gills, shrimp,hairtail intestines, roasted crab) Frozen salted fish frozen imitation crab,canned mackerel,frozen imitation shrimp, salted seasoned roe,salted seasoned fish, salted seasoned cuttlefish, and seafood with rice. 16[][][][] 2/18/04 Collier County Produce, Inc. All Histamine Empresa Pesqueria DBA Producing Fish de Barra de Sao Joao Captain Jerry's Seafood 16A---- Avenida Amaral Alias 9/5/02 Peixoto, 117 8551 NW 30th Terrace Barra de Sao Joao Miami, FL 33122 Municipio de FEI# 3001853060 Casimiro de Abreu Rio de Janeiro Brazil FEI# 1000155883 Domestic Cheese Co.Inc. Anchovies and Vacuum Jean-Gui SA 450 Toland Street Packed Salmon 50 Avenue Jean-Monet San Francisco, CA. 94124 16A[][]01 13410 Lambesc, France FEI #2910638 11/5/03 FEI #3000283888 Jean-Gui Avenue Pierre Guadin BP 91, Le Luc en Provence, France FEI #1000192361 Corpa Productos Del Mar Ibai-Ondo, 2 No 8 Lasarte-Oria, Spain FEI #3003338567 H & K Inc. dba: Palama Supermarket All fish and fishery Daihung Mulsan Co. 1210 Dillingham Blvd. products 828 Misuk-Don Honolulu, Hawaii 16[][][][][] (Misoo), Chungmu FEI# 3000284817 09/24/01 Tongyong City Kyungnam (Gyeungna) FEI #1000273546 Hung Chong Lung Inc. Dried Oysters Showa Trading Co. 16578 Valley Blvd. 16E- - 03 No. 8-14, 5-Chome La Puente, CA 91744 03/5/04 Shimoyamate-Dori, Chuo-Ku FEI# 3002874219 Kobe, Japan FEI# 3004396647 InterExpress Fresh Smelt Comercial Kiel Corp. Fillets S.A. 7225 NW 25th St 16A36 Puerto Montt, Chile Miami, FL 33122 11/17/99 FEI# 3002203333 Whole Fresh Trout Aquapuro S.A. 16A44 Santiago, Chile Aquaculture Trout FEI# 1000424429 16X05 Fresh Whiting (Includes Vacuum Packed) 16A49 All Fishery Products Subject to DWPE Except: International Gourmet All Fish/Fishery products All Food, Inc 16[][][][][] 7520 H. Fullerton Rd. 12/6/02 Springfield, VA 22153 FEI #1000123364 J. Sardinas, Inc. Barracuda 16A--02 Gulf Fish Express 7225 NW 25th Street Moray eel 16A--15 S.A. De C.V. Miami, FL 33122 Grouper 16A--17 Calle 33A, No.203-A FEI# 1000113995 Pompano 16A--29 Progreso, Yucatan 4/19/00 Snapper 16A--37 Mexico (only Etelis and FEI# 3002485340 Lujanus species) Fish NEC 16A--99 (Aholehole, goatfish (only Mulloidichthys Pseudupeneus,and Upeneichthys lineautus species);hind, hogfish, parrotfish and tange (from tropical Pacific Ocean only; squirrelfish,triggerfish(only Balistes, Canthidermis sufflamen and Melichths niger species only) Surimi 16R--01 (engineered seafood if made from above identified products) Kenbourne International, Inc. Mahi Mahi Doblertel S.A. 2000 NW 95th Avenue 16A--52 Aka Miami, FL 33172 8/26/04 Cepromar FEI# 1000525448 Ciudadela Kennedy 3002631944 Escolar Calle #108 3003661788 16A -69 Guayaquil 8/26/04 Ecuador FEI# 3004303128 Tuna 16 -45 8/26/04 Marlin 16A -54 8/26/04 Wahoo 16A--78 8/26/04 LAX-C Inc. Frozen Mackerel PA Siam Intertrade Co. Ltd. 1100 N. Main St. 16A- - 73 619, 621, 623, Los Angeles, CA 90012 16A- - 22 1138/39-41 Rama 3 Rd. FEI # 3002452320 09/29/03 Bangpongpang, Yannawa, Bangkok, Thailand FEI# 13365 Frozen Sweet Fish Pa-Siam Intertrade Co., Ltd. 16A -- 09 1138/14-16 Rachadapisake Rd. 16A -- 99 Bangpongpang, Yannawa Bangkok 8/11 /04 Thailand FEI #13365 (MANUFACTURER) Mandalay Trading Corp. Canned Mackerel Slord Development 903 South Azusa Ave. in Oil Corp. City of Industry, CA 91748 16A--22 Navotas Fish Port FEI# 3003871642 4/20/04 Complex Navotas, Metro Manila Philippines FEI# 3003282400 (DISTRIBUTOR) Hiap Hong Trading Co. Manila, Philippines FEI# 3003807940 Salted Anchovies Golden Hands 16A- 01 Manufacturing Corp. 4/20/04 Bldg.12 Santos Industrial Compound 60 Leono Street Malabon, Metro Manila Philippines FEI# 3002809011 Pal-Do World Frozen round yellow Keum San Ind. Co.Ltd 8730 S.Tacoma Way croaker 755-9 Woodu Ri, Tacoma, WA 98499 16A[][]13 Dolsan Eup Yeochum Kun FEI #3000258351 10/1/02 Chonnam, South Korea FEI #3002406217 Frozen fried fish Cham Food Co. cakes 571 Jam Lim Dong 16C[][][][] Busan, South Korea 10/1/02 FEI #3003455416 Frozen fish cakes Dong Won Company 16C[][][][] 346-16 Yuensang Dong 10/1/02 Yeunjae-Gu Busan, South Korea FEI #3003303738 Seasoned salted Han Sung Co. squid 15916 an Dong Kim Hae Si 16M[][]03 Gyung Nam, South Korea 10/1/02 FEI #3003419159 Poland's Best Inc. LACF Seafood DOS Spolka ZO. O. 735 Canal Street Products 15 Warszawska Building 15 & 18 Rear 16A-E- - Lebork 84 300 Stamford, CT 06902 11/25/03 Poland FEI# 3001551452 FEI #3002494358 Slade Gorton & Co., Inc. Frz. vacuum packed Pesquera Palacious Rocky Bay Fishing Co. pasteurized S.A. 225 Southampton Street (precooked) whole Magnere 1543 Boston, MA 02118-2724 mussels/16EV[]04 Providencia, 04/13/01 Santiago, Chile FEI# 1000144101 Smoki Foods, Inc. Salmon ALL 206 SW Michigan St. 16A--01 Seattle, Washington 98124 16X--03 FEI# 1000524559 3/5/04 Snodgrass Seafood Fresh Grouper All 6928 East 14th St. 16A--17 Brownsville, TX 78520 FEI #1627137 12/3/01 Top Katch Seafood Inc. All fish & Victor Segundo 2380 NE 183rd Terrace fish products Plasencia Castillo Miami, FL 33160 16[][][][][] Jorge Bustamante 219-2do Piso FEI# 3001735380 11/19/03 Lima, Peru FEI# 3003966265 Tuna Fresh, Incorporated All Scombrotoxin All 1177 N.W. 81st Street (histamines) forming fish Miami, FL 33150 species FEI# 3002698900 16A[][] 5/17/04 (Also doing business as): Tuna Fish Incorporated " " All 405 Gretna Boulevard, Suit 208 and/or 1501 whi8tney Avenue Gretna, Louisiana 70056 FEI# 3003003398 Tuna Fish Incorporated " " All 40679 Highway 23 Boothville, Louisiana 70038 FEI# 3001688817 ATTACHMENT B COUNTRIES WITH FISH/FISHERY PRODUCT HACCP MOUs OR SIMILAR AGREEMENTS COUNTRY PRODUCT(S) PRODUCT CODE EFFECTIVE DATE Canada Raw Molluscan Shellfish 16E[][][] April 30, 1948 Chile Raw Molluscan Shellfish 16E[][][] May 18, 1989 Renewed: February 23, 2001 New Zealand Raw Molluscan Shellfish 16E[][][] October 30, 1980 South Korea Raw Molluscan Shellfish 16E[][][] April 8, 1987 Renewed: October 28, 1998 Note: Raw molluscan shellfish include fresh and frozen oysters, clams, mussels and whole or roe-on scallops.