"Detention Without Physical Examination of Refrigerated (Not Frozen) Vacuum Pakaged or Modified Atmosphere Packaged Raw Fish and Fishery Products Due to the Potential for Clostridium Botulinum Toxin Production"

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.")

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 Green List (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 on the Green List, 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 vavuum or modified atmosphere on all products inside the container.


This information should be forwarded to CFSAN, Office of Compliance, HFS-607. 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 in the Green List to this alert.

For questions regarding these criteria and/or products covered, contact CFSAN/Division of Enforcement/Manufacturing and Storage Adulteration Branch, HFS-607.

For questions or issues concerning science, science policy, sample collection, analysis, preparing, or analytical methodology, contact the Division of Field Science at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Refrigerated (not frozen), vacuum or modified atmosphere packaged raw fish and fishery products.

"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 whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]"

OASIS charge code - INSANITARY

"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 - MFRHACCP