"DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN WITH PROPER LABELING) RAW FISH AND FISHERY PRODUCTS IN REDUCED OXYGEN PACKAGING DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 11/6/2023 updates the name of the alert, reason for alert, guidance, agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). *** Clostridium botulinum (C. botulinum) is an anaerobic bacterium, meaning it can grow in low oxygen conditions, that is widely distributed in nature, in soil, the sediment of streams, lakes, and coastal waters, and in the intestinal tracts of fish and mammals. The toxin produced by C. botulinum is considered one of the most poisonous naturally occurring substances known and when ingested can result in paralysis, leading to death from asphyxiation. FDA considers the hazard of C. botulinum growth and toxin formation reasonably likely to occur in fish and fishery products in reduced oxygen packaging (ROP). ROP encompasses a large variety of packaging methods including vacuum packaging (VAC), modified atmosphere packaging (MAP), hermetically sealed containers, sealed plastic or laminated packaging, packing in oil, and using a material that is not considered oxygen-permeable. Packaging that is not considered oxygen-permeable restricts the exchange of oxygen and can lead to any oxygen present in the packaging being utilized by spoilage organisms resulting in a reduced oxygen environment. By reducing or preventing the exchange of oxygen, a processor introduces the hazard of C. botulinum growth and toxin formation. FDA considers packaging with an oxygen transmission rate (OTR) of 10,000 cc/m2/24hrs at 24�C (75�F), or higher to be oxygen-permeable packaging for fishery products and is not considered ROP. Oxygen-permeable packaging should provide a sufficient exchange of oxygen to allow naturally occurring aerobic spoilage organisms on the fishery product to grow and spoil the product before C. botulinum toxin is produced under moderate abuse temperatures. Use of an oxygen-permeable package may not compensate for the restriction to oxygen exchange created by practices such as packing in oil or the use of oxygen scavengers in the packaging. For eviscerated fish and fishery products in ROP, refrigeration alone is not sufficient to control C. botulinum throughout distribution because non-proteolytic strains of C. botulinum, commonly found in seafood, can grow at 38�F (3.3�C) and above. In 1992, the National Advisory Committee for Microbiological Criteria for Foods (NACMCF) evaluated the microbiological safety issues associated with VAC/MAP refrigerated raw fishery products and found that the primary preventive measure against C. botulinum is temperature control below 38�F (3.3�C) from time of packaging through preparation. With current practices and abuses at the retail and consumer level, maintenance of a storage temperature below 38�F (3.3�C) from time of packaging to consumption is unlikely. 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 VAC/MAP raw fish at temperatures of 45�F to 50�F (7.2 �C to 10�C). Several studies indicate that temperatures between 45�F and 50�F are frequently encountered in retail storage coolers, retail display coolers, and home refrigerators. FDA considers these fish and fishery products in ROP to be a potentially life threatening, acute health hazard because when temperatures are 38�F (3.3�C) and above C. botulinum spores may germinate into vegetative cells, multiply, and produce deadly toxin. FDA currently recommends the following as control strategies for C. botulinum in eviscerated fish and fishery products in ROP:*** 1. When refrigeration control below 38�F (3.3�C) is the sole control for the C. botulinum hazard, use a Time-Temperature Indicator (TTI) on each ROP package AND maintain the product below 38�F (3.3�C). Since product will likely not be maintained below 38�F (3.3�C) during distribution, TTIs are needed to monitor time and temperatures exposures throughout distribution until consumption. TTIs should be designed specifically for C. botulinum and alert consumers and end users of potentially unsafe time and temperature exposures that could result in toxin formation. 2. Freeze the product immediately after packaging, maintain the product frozen throughout distribution, and clearly label ***each individual package*** of the product to be held frozen and to be thawed under refrigeration immediately before use (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use"). *** The labeling should have two parts with instructions to keep the product frozen and for proper thawing. Thawing can be done in the ROP under refrigeration immediately before use or it is also acceptable for the labeling to require removal from packaging before thawing. Removing the seafood from ROP will also remove the hazard of C. botulinum growth and toxin formation. Proper labeling is critical to prevent time and temperature exposures during thawing that are conducive for botulinum toxin production. Note: These products are not subject to this import alert, if properly labeled. 3. Formulate the finished product to create a secondary barrier such as: a water activity below 0.97; or a water phase salt of at least 5%; or a pH of 5.0 or less AND maintain the product at 40�F (4.4�C) or below. Note: These products are not subject to this import alert.***

Product Description

Refrigerated (not frozen) raw fish and fishery products in ROP; ***frozen improperly labeled raw fish and fishery products in ROP***; and any raw uneviscerated or partially eviscerated fish in ROP that is either refrigerated or frozen.

Charge

he article is subject to refusal of admission pursuant to Section 801(a)(3) 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 and "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

Guidance

*** Divisions may detain without physical examination 1. All refrigerated (not frozen), raw fish and fishery products in ROP. These products should be refused, and the firm's corrective actions should include revising their HACCP plan, supporting documentation, and procedures to control C. botulinum in future ROP product to demonstrate that the condition that gave rise to the violation has been resolved and to prevent recurrence of the violation. 2. Any raw, uneviscerated or partially eviscerated fish in ROP that is either refrigerated or frozen. Because C. botulinum is known to be present in the viscera of fish, there are no known control strategies for raw, uneviscerated or partially eviscerated fish in ROP that is either refrigerated or frozen, regardless of size, therefore FDA does not recommend the use of ROP on raw, uneviscerated or partially eviscerated fish that is either refrigerated or frozen and would consider the product to be adulterated under section 402(a)(4) of the Food, Drug and Cosmetic Act when the C. botulinum toxin hazard is not controlled. Fish should be completely eviscerated before being placed in ROP. Evisceration should include the removal of gills, gonads, viscera, and other internal organs. Uneviscerated or partially eviscerated fish in ROP should be refused, and the firm's corrective actions should include revising their HACCP plan, supporting documentation, and procedures to completely eviscerated the fish and to control C. botulinum in future ROP product to demonstrate that the condition that gave rise to the violation has been resolved and to prevent recurrence of the violation.*** ***Frozen raw fish and fishery products in ROP not properly labeled with two parts for the ROP to be held frozen and to be thawed under refrigeration immediately before use or removed from packaging before thawing on each individual ROP unit. These products should be added to the Red List of this import alert. Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). Detained frozen product in ROP may be released after being properly labeled. To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the processor has resolved the conditions that gave rise to the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). Documentation should include a HACCP plan with a critical control point for labeling, a copy of a critical control point monitoring record for labeling, and a copy of product labeling to demonstrate implementation of the HACCP plan. *** *** The following eviscerated fish and fishery products should not be detained, per this Import Alert: 1. Frozen products clearly labeled to be held frozen and to be thawed under refrigeration immediately before use (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use"). Alternatively, the packaging can be labeled for the product to be held frozen and to be removed from packaging before thawing (e.g., "Important, keep frozen until use, completely remove from packaging before thawing"). These products should be frozen immediately after packaging and maintained frozen throughout distribution. *** 2. Products with the manufacturer/shipper identified on the Green List. ***Recommendations for additions to the Green List of this import alert, should be forwarded to the Division of Import Operations (DIO) and FDA's Human Foods Program (HFP) will evaluate regulatory packages on a case-by-case basis.*** To request addition to the Green List, the following documentation on C. botulinum controls and packaging should be provided to FDA: ***1. Processors using packaging considered oxygen-permeable (OTR of 10,000 cc/m2/24hrs at 24�C (75�F), or higher) should submit documentation from the packaging manufacturer for the packaging description and OTR. These products should use the recently created product code subclass X for Oxygen Permeable Packaging.*** ***2. Processors that use a TTI on each ROP package AND maintain the product below 38�F (3.3�C) should provide a HACCP plan and the TTI manufacturer's specifications. The HACCP plan, at a minimum, should list critical control points for finished product storage below 38�F (3.3�C) and TTI use and application. The critical control points and critical limits for the TTIs should be based on the TTI manufacturer's specifications. These products should use the recently revised product code subclass V for Vacuum, MAP, and other Reduced Oxygen Packaging.*** The above documentation should be sent via email to FDA's Division of Import Operations, at: ImportAlerts2@fda.hhs.gov For more information on C. botulinum and controls see Chapter 13 of FDA's Fish and Fishery Products Hazards and Controls Guidance and FDA's Seafood HACCP Video titled "Time-Temperature Indicators" available at www.fda.gov/seafood. *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***

Affected Countries (1)