DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN) RAW FISH AND FISHERY PRODUCTS THAT ARE VACUUM PACKAGED OR MODIFIED ATMOSPHERE PACKAGED OR PACKAGED IN A MATERIAL THAT IS NOT OXYGEN-PERMEABLE DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION

The revision of this Import Alert, dated 03/26/2012, updates the name of the import
alert and includes information to include packaging that is not oxygen-permeable.
Changes bracketed by ***

*** 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 (C. botulinum) is temperature control below 38ºF (3.3ºC) 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 below 38ºF (3.3ºC) 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 45ºF to 50ºF (7.2 ºC to 10ºC). A number of studies indicate that temperatures between 45ºF and 50ºF 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 that C. botulinum spores may germinate into vegetative cells, multiply and produce deadly toxin.

Packaging that provides an oxygen transmission rate of 10,000 cc/m2/24hrs at 24ºC (75ºF), or higher, is regarded as an oxygen-permeable packaging material for fishery products. An oxygen permeable package should provide sufficient exchange of oxygen to allow naturally occurring, aerobic spoilage organisms on the fishery product to grow and spoil the product before toxin is produced under moderate abuse temperatures.

Therefore, FDA considers refrigerated fresh raw fish products that are packaged in the following forms to be adulterated under section 402(a)(4) of the Food, Drug and Cosmetic Act because the C. botulinum toxin hazard is not controlled:

1. packaged using material that is not oxygen-permeable;
2. vacuum packaged; or
3. packaged under modified atmospheric conditions.

*** Districts may detain, without physical sampling and analysis, 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,

Or

Products that are packaged in a material that is not oxygen-permeable,

This import alert does not apply to the following products or conditions:

1. Raw fish 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.").

2. Raw fish packaged in films/materials regarded as oxygen permeable has an oxygen transmission rate of 10,000 cc/m2/24hrs at 24ºC (75ºF), or higher. Oxygen permeable package is expected to provide sufficient exchange of oxygen to allow aerobic spoilage organisms to grow and spoil the product before toxin is produced under moderate abuse temperatures.

3. Fish products formulated in such a manner that a secondary barrier to C. botulinum toxin production is achieved through factors associated with the final formulation. Appropriate secondary barriers could include:
1) a final water phase salt level of at least 5 percent; or
2) a final water activity below 0.97; or
3) a final equilibrium pH of 5.0 or less.

For questions regarding these criteria or whether products are covered, contact CFSAN/OC/DE/MSAB.

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

Manufacturers/shippers and products listed on the Green List should not be subject to detention without physical examination under this import alert. To be listed on the Green List, manufacturers, shippers, or importers should provide information to FDA that establishes controls are in place to reduce the potential for C. botulinum toxin production.

The above documentation should be submitted for evaluation to FDAs CFSAN at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Manufacturing and Storage Adulteration Branch (HFS-607)
5100 Paint Branch Parkway
College Park, MD 20740

When a determination that a specific vacuum packaged, MAP product, or material that is oxygen-permeable is not subject to DWPE, the firm and product will be identified o the Green List of this import alert. ***

Refrigerated (not frozen) *** raw fish and fishery products because the products are packaged in a material that is not oxygen-permeable, vacuum packaged, or modified atmosphere packaged. ***

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

PROBLEM:
Potential for Clostridium botulinum