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Warning Letter Addresses Botulism Risk

The U.S. Food and Drug Administration (FDA) has advised a Kentucky seafood processing facility to break the vacuum seals on its Tilapia packages before thawing the fish to eliminate the threat of botulism.

The suggestion came in a Feb. 24 “Warning Letter” to Acquired Holding, Inc., which owns the seafood processing facility in Buckner, KY, from Teresa C. Thompson, FDA’s Cincinnati District director.

Acquired Holding, Inc. was said to be violating the federal Food, Drug, and Cosmetic Act and its various regulations because it does not have a seafood Hazard Analysis and Critical Control Point (HACCP) plan for its Tilapia and Lemon Pepper Catfish.

Aquired Holding, Inc. does not have a HACCP plan for, “Tilapia that you receive frozen and sealed in modified air packaging to control the food safety hazard of Clostridium botulnum growth and toxic formation during the extended thawing period that you conduct under refrigerated conditions while the packages remain sealed,” Thompson wrote.

“Alternatively, because the Clostridium botulinum toxin hazards is not reasonably likely in the absence of the vacuum seal, your firm may wish to break the vacuum seal on each package prior to thawing to eliminate the hazard,” she added.

Vacuum packaging extends the life of seafood in the case, but it also increases the risk of deadly botulism, some experts say.

FDA also advised the Kentucky seafood processor to include “FD&C Yellow #5” on its ingredient statements.  Acquired Holding Inc. last November had to recall ten and fifteen pound packages of its Lemon Pepper Catfish for failing to disclose food coloring.

The seafood processor was also warned about critical temperature limits for receiving and storing its pasteurized canned crabmeat.  Not controlling the “biological temperature” risks pathogen growth and potential toxin formation, including botulism.

It received similar warnings for its fresh crabmeat processes, including the need to monitor transit and storage temperatures around the clock.  “This is particularly important because your firm is also conducting thawing of fresh vacuum packaged fish in your cooler.”

The Kentucky company also has some labeling problems. For example, one of its allergen warnings says “Contains Fish.”   FDA says that is not required when the product it catfish.

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