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.