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