IA #16-125 - 9/25/02,"IMPORT ALERT # 16-125, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF REFRIGERATED (NOT FROZEN) VACUUM PACKAGED OR MODIFIED
ATMOSPHERE PACKAGED RAW FISH AND FISHERY PRODUCTS DUE TO THE POTENTIAL FOR
CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION" 9/24/08
TYPE OF ALERT: Detention Without Physical Examination
(NOTE: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or
product(s) at issue. It does not create or confer any rights
for or on any person, and does not operate to bind FDA or
the public.)
PRODUCT: Refrigerated (not frozen), vacuum or modified atmosphere packaged
raw fish and fishery products.
PRODUCT CODE: 16[]VC[][]
PROBLEM: Potential for Clostridium botulinum toxin production
(botulism).
PAF: MIC
PAC: 03844
COUNTRY: All
MANUFACTURER
FEI#: All
IMPORTER's
ID#: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(1) of the Act in that it appears to have been
prepared, packed or held under insanitary conditions
[Adulteration, Section 402(a)(4)]."
OR
"The article is subject to refusal of admission pursuant to
section 801(a)(3) of the Act in that it appears to have been
prepared, packed, or held under insanitary conditions
whereby it may have been rendered injurious to health in
that it appears to have been processed in violation of 21
CFR 123.6(a) and 123.8(a) [Adulteration, Section
402(a)(4)]."
OASIS CHARGE
CODE: INSANITARY
RECOMMENDING
OFFICE: CFSAN, Office of Field Programs, Import Branch (HFS-606)
CFSAN, Office of Seafood, Program and Enforcement Branch
(HFS-417)
REASON FOR
ALERT: In 1992, the National Advisory Committee for Microbiological
Criteria for Foods (NACMCF) evaluated the microbiological
safety issues associated with vacuum or modified atmosphere
packaging of raw fish and fishery products and found that
the primary preventive measure (critical control point)
against the growth and toxin production of non-proteolytic
strains (those strains that grow at refrigeration
temperatures) of Clostridium botulinum is temperature
control at or below 38 F (3.3 C) from time of packaging
through consumption. The scientific literature demonstrates
that, with current practices and abuses at the retail and
consumer level, maintenance of a storage temperature of 38 F
(3.3 C) from time of packaging to consumption is not likely.
Studies conducted by FDA in 1996 and 1997 indicate that
toxin production may precede absolute spoilage and rejection
by the consumer in extended shelf life Modified Atmosphere
Packaged (MAP) and vacuum packaged raw fish at temperatures
of 45 to 50 F (7.2 to 10 C,). A number of studies indicate
that temperatures between 45 and 50 F are frequently
encountered in retail storage coolers, retail display
coolers, and home refrigerators. FDA considers these
products a potentially life threatening acute health hazard
because of the possibility of contamination with C.
botulinum toxin.
Therefore, FDA considers refrigerated fresh fish products in
vacuum packaging or modified atmosphere packaging to be
adulterated under section 402(a)(4) of the Food, Drug and
Cosmetic Act when the C. botulinum toxin hazard is not
controlled. FDA is aware of two ways to pack this product
safely. First, a second barrier can be utilized. Second,
an indicator can be used in/on the packaging to show that
the product has not been exposed to a time and temperature
combination that could result in an unsafe product between
the time of packaging and the time of use by the consumer.
NOTE: This import alert does not apply to product that has
been frozen immediately after processing, maintained frozen
throughout distribution, and clearly labeled to be held
frozen and to be thawed under refrigeration immediately
before use (e.g., "Important, Keep Frozen, Thaw Under
Refrigeration Immediately Before Use.")
GUIDANCE: Districts may detain without physical examination all
refrigerated (not frozen), raw fish and fishery products
packaged as follows:
Vacuum packaged (Vac-pac) - the air has been removed, or
Modified atmosphere packaged (MAP) - the air has been
removed and replaced with a mixture of gases that result in
an oxygen concentration less than that found in the
atmosphere, i.e., less than 21 percent.
Manufacturers/shippers and products listed in the Attachment
(List of shippers/manufacturers and products not subject to
detention without physical examination) should not be
subject to detention without physical examination for the
reasons in this import alert. To be listed in the
Attachment, manufacturers, shippers, or importers should
provide the information to FDA to establish that controls
are in place to either prevent C. botulinum toxin formation
or provide a visual indication of a potential problem. As
set out in the Fish and Fishery Products Hazards and
Controls Guidance, three potential controls are:
1) Packaging specifications from the packaging manufacturer
stating that the packaging material has a permeability of
more than 10,000 cc/m2/24 hour at 24 C (75 F);
OR
2) Private laboratory analysis which establishes that the
water phase salt level is at least 5 percent or the water
activity is below 0.97, or the pH is 5.0 or less;
OR
Evidence that the product(s) bear a validated Time
Temperature Integrator (TTI) that indicates, by a color or
other visual change, if the product has been exposed to a
time and temperature combination that could result in an
unsafe product. A single TTI on bulk containers is not
acceptable except where opening the bulk container releases
the vacuum or modified atmosphere on all product inside the
container.
This information should be forwarded to CFSAN, HFS-606 for
evaluation. When a determination has been made that a
specific vacuum packaged or MAP product from a specified
processor is not subject to DWPE, the firm and product will
be listed on the attachment to this alert.
For questions regarding these criteria and /or products
covered, contact CFSAN/DOEP/Imports Branch, HFS-606, (301)
436-1622 or (301) 436-1623.
For questions or issues concerning science, science policy,
sample collection, analysis, preparing, or analytical
methodology, contact the Division of Field Science at (301)
827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Raw, refrigerated, vacuum or modified atmosphere packaged
fish, botulism, toxin
PREPARED BY: Doug Randes, DIOP, (301)443-6553
Brian Landesberg, CFSAN, DOEP, (301)436-1622
Mary Losikoff, CFSAN, OS, (301)436-2300
DATE LOADED
INTO FIARS: September 25, 2002
Attachment for Import Alert #16-125 9/24/08
List of shippers/manufacturers Not Subject To DWPE
NOTE: the TTI manufacturer has discontinued manufacturing the Vitsab M2-10 TTI
replacing it instead with Vitsab Checkpoint L5-8.)
FIRM PRODUCT DATE PRODUCT CODE
(Manufacturer)
Aqua Chile All vacuum 6/17/08 16AV[][][]
Cardonal Lote B Sn packed fish 16XV[][][]
Puerto Montt
Chile
FEI #3005543425
(Importer)
Global Fresh Foods Inc. 6/17/08
967 Colton Street
Monterey, CA 93940
FEI# 3006761248
method of control: SAF-D containers/packages
(for questions concerning specific criteria required for SAF-D
containers/packages contact CFSAN, HFS-607, Millie Benjamin at
301-436-1427)
Atum Do Brasil Captura Grouper, snapper, 10/7/05 16AVC17/
E Comercio Ltda. tuna, swordfish 16AVC37/
Rua Sebastiao Alves de 16AVC42/
Almeida s/n 16AVC45
Praia de Itaoca
Itapemirim, Brazil
FEI# 3005044673
Austral Food S.A. Vacuum Packaged 9/23/05 16AV[][][]
Volcan Lascar Poniente Fresh Fish 16XV[][][]
781, Pudahuel, Chile
FEI# 3004011658 (Method of control: Vistab M2-10 single dot)
Azuma-Cho Gyogyo Kyodo Yellowtail 04/12/06 16AV[]79
Kumial Amerjack 04/12/06 16AV[]79
1229 Shoura, Azuma-cho
Izumi-gun,
Kagoshima Prefecture,
Japan 899-1403
FEI# 3001448949 Method of control: Vitsab Checkpoint L5-8 TTI
Beacon Fisheries All vacuum 6/27/05 16AV[][]
12643 Hidden Circle East packed fish 16XV[][]
Jacksonville, Florida 32225
FEI# 3002927749
Burimy Co., Ltd. Fresh amberjack 4/4/06 16AVC79
446 Kusuura-machi Fresh yellowtail 4/4/06 16AVC79
Hondo-shi, Kumamoto-pref
Japan 863-0044
FEI: 3004250429 TTI method of control: Cryovac BDX 9124 (or
FEI: 3004651292 HP2700 10K OTR) bags.
Caiman Products S.A. de C.V. Snapper 6/27/05 16AV[]17
Calle 120 No. 155 x 31 y 33 Grouper fish 16XV[]37
Col. Centro C.P. 97320 (Cryovac BDX 9124 or
Progreso, Yucatan, Mexico HP2700 10K OTR bags supplied by
FEI# 3004336020 ^
^)
Compania Pesquera MAP Fresh Salmon 5/11/07 16AVC32
Camanchacha S.A. Fillets 16XVC03
El Golf 99, Piso 10
Las Condes
Santiago
Chile
FEI# 3002926774
(method of control: MAP applied by Carrier Transicold (M/V CCN1 Punta Arenas
V-718)and Vistab TTI model L5-8)
Costapesca Cia Ltd. Refrigerated 12/18/06 16[]VC[][]
Avenida Col¢n 535 y 6 (Not Frozen)
de Diciembre Vacuum Packaged
Quito, Ecuador or Modified
FEI# 3004348675 Atmosphere
Packaged
Raw Fish
Empacadora del Pacifico Ltda. Vacuum packed 9/13/07 16AV[]42
(dba: Empacadora Coral Del fresh swordfish 16AX[]42
Pacifico) (Xiphias gladius)
Ferrari 80
Los Espejos
Santiago, Chile
FEI# 1000155621
13361
(Method of control: TTI Vitsab Checkpoint L5-8)
Empresas Aquachile S.A. MAP Fresh Salmon 5/11/07 16AVC32
Sector Cardonal, Fillets 16XVC03
Lote B S/N
Puerto Montt
Chile
FEI# 3005041759
(method of control: MAP applied by Carrier Transicold (M/V CCN1 Punta Arenas
V-718)and Vistab TTI model L5-8)
Exportadora De Productos All Vacuum Packed Fish 3/23/04 16AV---
Del Mar S.A. (Expomar S.A.) 16XC---
Km 10.5 Carretera Sur
Apartado 3662
Managua, Nicaragua
FEI# 3004333204
Exportadora Frumar, S.A. All Vacuum 5/11/04 16AV[][]
1.5 Kms. Oeste Pacto Packed Fish 16XV[][]
Del Jacote
El Coyol, Alajuela
Costa Rica
FEI# 3004251317
Exportadora PMT S.A. All Vacuum Packed Fish 12/17/03 16AV---
6 Km al Oeste de Forum, 16XV---
Carretera a Ciudad Colon
Ciudad Colon, San Jose,
Costa Rica
FEI# 3004867144 Address Change 8/22/07
Frigolab San Mateo Cia Ltda All Vacuum Packed Fish 11/29/06 16[]VC[][]
San Mateo Km.4«
Manta, Ecuador
FEI# 1000156635
Heian Kaisan Co., Ltd. Vacuum Packed Yellow Tail 4/29/05 16AV[]79
3338-26, Ushibuka mach Fillets
Ushibuka-shi, Kumamoto-Prefecture
JP-43 8631901
Japan Method of control: Vitsab Checkpoint L5-8 TTI
FEI# 3004304236
(For questions concerning TTI please contact
CFSAN Imports Branch 301-436-1622)
NOTE: Each Time Temperature Indicator (TTI) is different with different
limitations, the above firm uses a Vitsab M2-10 single dot TTI (For
questions concerning TTI please contact CFSAN Imports Branch 301-
436-1622).
Hyoshoku Co., Ltd. Vacuum packaged 7/19/06 16AVC79
3284-71 Takasu-cho refrigerated farmed
Tsukumi, yellowtail or
Japan-44 amberjack fillets
FEI# 3004265183
3005395967 (Method of Control: Vistab Checkpoint L5-8 TTI)
Importadora y Exportadora Fresh Vacuum Packaged 4/26/07 16-VC--
San Isidro Ltda. Seafood Products
Av. Volcan Lascar No. 730
Pudahuel, Santiago
Chile
FEI# 3005740496 (method of control: TTI Vistab model L5-8)
Industrias Del Mar Lubar CIA. Raw Seafood Products 12/7/07 16[]VC[][]
LTDA.
Km 4.5 Via Manta-Portoviejo
Manta, Ecuador
FEI #3004124303
(method of control: Sealed Air Cryovac 10K ORT Bags)
Industrias Martec S.A All seafood products 3/11/03
El Ranchon de Boca Vieja Control method:
Apartado 20 "Sealed Air Cryovac HP2700 bags CRYOVAC 10K OTR"
Quepos, Costa Rica
FEI# 3004251644
3001655667
Industrial Pesquera Santa Vacuum Packed 2/16/05 16A[][]58
Priscila S.A. Tilapia 16X[][]06
Km 5.5 Via a Daule
Guayaquil
ECUADOR
FEI# 1000255182
Kaneko Sangyo Co., Ltd. Fresh yellowtail 4/3/06 16AV[]79
1-21, Nakase-dori (Hamachi)
Karatsu City, Saga-ken
Japan
FEI# 3004875088 (Method of control: Vitsab L5-8 TTI)
KUMAMOTO-KEN YOUSHOKU Fresh Yellowtail Fillet 1/26/05 16AV-79
GYOGYOU-KYOUDO KUMIAI
SUMOTO FACTORY
3361-3 Yanagida Baba
Sumoto-town
Amakusa-gun
Kumamoto-ken 861-6303
Japan
FEI# 1000412469
Mainstream Chile S.A. MAP Fresh Salmon 5/11/07 16AVC32
Avda. Diego, Portales Fillets 16XVC03
2000 Piso 10
Puerto Montt, Chile Address change
FEI# 3004843573 9/17/08
(method of control: MAP applied by Carrier Transicold (M/V CCN1 Punta Arenas
V-718)and Vistab TTI Model L5-8)
Marine Harvest Chile S.A. MAP Fresh Salmon 5/11/07 16AVC32
Camino Chinqui s/n, Km. 12 Fillets 16XVC03
Puerto Montt
Chile
FEI# 3003625111
(method of control: MAP applied by Carrier Transicold (M/V CCN1 Punta Arenas
V-718) and Vistab TTI Model L5-8)
Marshall Islands Fishing Fresh tuna (loins 07/19/06 16AV[]45
Venture, Inc. and fillets)
P.O. Box 437
Majuro, Republic of Fresh marlin (loins 07/19/06 16AV[]54
Marshall Islands and fillets)
MH 96960
FEI# 3003529818
Ocean Fish Co. S.A. Vacuum Packed Mahi Mahi 12/20/06 16AV-51
Km 4« Via Manta-Montecristo
Manta, Ecuador Vacuum Packed Marlin 12/20/06 16AV-54
FEI# 3003366507
3004695277
3004347364
(method of control: Cryovac HP 2700 bags 10K ORT)
Processor Physical Address:
Marshall Islands Fishing
Venture, Inc.
Delap MIMRA Fish Base
Majuro, Republic of
Marshall Islands
MH 96960
FEI# 3005375875
Productos Oceano S.A. All vacuum packed 04/13/07 16AV[][][]
Puerto Coquina fresh fish fillets and 16XV[][][]
Chepo loins
Panama
FEI# 3006215315
(Method of control: either the Vitsab Smart Label M2-10 TTI or the Cryovac 10K
bag)
TTI Method of Control: CRYOVAC HP2700 (BDX 9124) bags
Morimatsu Suisan Reito Vacuum packaged 3/3/06 16AV[]79
Co. Ltd. (Rumi Japan) fresh yellowtail
5/2/20 Tenphzan-Cho fillets
Imabari, Ehime, Japan
FEI# 1000500268 (Method of control: Vitsab L5-8 TTI)
Nanaimo S.A. Fresh, refrigerated 04/29/05 16AV[]42
Camino La Vara 02980 vacuum packed swordfish
Santiago, Chile loins
FEI #3004080615 (Method of control: TTI Vistab type L5-8))
Address change
6/21/05
TTI control method change 12/14/05
Pescados Delmar S.A. Snappers-black, 03/2/05 16AV[]37
Calle 31 #287 x 108y 110 red, yellow eye,
Progreso, Yucatan, black fin, yellow tail,
Mexico lane, hog, mutton, queen, B-Liner
FEI# 3003807588
Grouper-black, red, 16AV[]17
Snowy, yellow edge, gag,
Scamp.
Pesquera los Fiordos Ltda. Salmon 7/19/04 16AV-32
Pedro Montt 065, Oficina 410 16XV-03
Puerto Montt
Chile Trout 7/19/04 16AV-44
FEI# 3004323427 16XV-05
Pezfresco S.A. Rainbow Trout 03/2/05 16AV[]44
Calle 12 No. 23-28 All types-whole, 16XV[]05
B. Alamos head-on gutted,
Pereira, Colombia head-off gutted.
FEI# 3003096583
Phillips Seafood of Ecuador Mahi Mahi 11/5/03 16AV-51
Km 9.5 Via a Daule
Entrando Por Pipsa
Lotizacion Inmaconsa
Calles Mirtus Y Casuarinas
Guayaquil, Ecuador
FEI #3001319367
Productos Oceanicos Del Golfo Snapper 6/27/05 16AV[]17
S.A. De C.V. Calle 83A Grouper fish 16XV[]37
#204 x 114 y 116 (Cryovac BDX 9124 or
Progreso, Yucatan, Mexico HP2700 10K OTR bags supplied by
FEI# 3004278403 ^
^)
PROMAROSA Raw Seafood Products 8/2/07 16-VC--
Productos del Mar Santa Rosa
Cia. Ltda.
Calle 59 entre manzana 49 y 50
Salinas, Guayas
Ecuador
FEI# 3004307867
(Method of control: Cryovac HP 2700 10K ORT Bags)
PT. Balinusa Windumas All Vacuum Packed 12/28/07 16AV[][][]
Jl. Ikan Tuna ll Fresh Fish 16XV[][][]
Pelabuhan Perikanan Benoa
Denpasar, Bali
Indonesia
FEI# 3004289863 (method of control Cryovac Sealed Air
10K ORT Bags)
Salmones Multiexport S.A., MAP Fresh Salmon 09/24/08 16AVC32
Avenia Cardonal 2501 Fillets 16XVC03
Puerto Montt, Chile
FEI#3004259690
(method of control: MAP applied by Carrier Transicold (M/V
CCN1 Punta Arenas V-718)and Vistab TTI model L5-8)
Sea Harvest Fresh Seafood Products 08/02/06 16[]VC[][]
Fishing Port,
P.O. Box 459
Victoria
Mahe, Seychelles
FEI# 3004273612
(Method of control: in sealed Air Cryovac HP2700 Bags CRYOVAC 10K 0TR)
Seiki Inc. Fresh Vacuum Packed
7922-3 Kiire Maenchama-cho Yellowtail Fillets
Kagoshima-shi, Kagoshima 16AVC79
Japan 5/28/08
FEI #3004200295
(method of control: Vitsab CheckPoint L-Series (5-8)Time Temperature
Indicators)
True North Salmon Co. Fresh Salmon 8/21/03 16V--32
14 Magaguadavic Drive
St. George, NB ESC 3H8
Canada
FEI# 3003080942
(manufacturer)
Tahiti Island Seafood All vacuum packed fish 5/27/08 16AV[][]
Lot Sage 16XV[][]
BP 380539, Tamanu
98718 Punaauia
Tahiti, French Polynesia
FEI #3004670687
method of control: Cryovac (or HP2700 10K ORT) bags
(Importer)
Blue Quality USA LLC 5/27/08
1103 Cymry Drive
Berwyn, PA 19312
FEI# 3006805640
|
