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"
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 7/19/04
List of shippers/manufacturers Not Subject To DWPE
FIRM PRODUCT DATE PRODUCT CODE
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 Del Jacote Packed Fish 16XV[][]
El Coyol, Alajuela
Costa Rica
FEI# 3004251317
Exportadora P.M.T., S.A. All Vacuum Packed Fish 12/17/03 16AV---
Apartado Postal 306 16XV---
Escazu 1250
San Jose, Costa Rica 6155
FEI #1000155350
Industrias Martec S.A 3/11/03.
El Ranchon de Boca Vieja
Quepos, Costa Rica
FEI #3002516582
Morimatsu Suisan All vacuum- 9/5 /03 16AV- -
Reito Co. Ltd. packed fish 16XV- -
(aka Rumi Japan)
5-2-20 Tenpozan
Imabari, Japan
FEI #1000500268
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
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
True North Salmon Co. Fresh Salmon 8/21/03 16V--32
14 Magaguadavic Drive
St. George, NB ESC 3H8
Canada
FEI #3003080942