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Getting Botulism Control Right in an HACCP Plan

The U.S. Food and Drug Administration (FDA) is having a little disagreement with a Fort Lauderdale seafood processing facility over how to control the potential for deadly botulism.

The seafood processing facility, owned by Cemco International Corp., has been trying since last June 14-15, when it had its last inspection, to write a seafood Hazard Analysis and Critical Control Point (HACCP) plan that will satisfy FDA.

In a Dec. 14 warning letter to Cemco, FDA informed the seafood processor that its HACCP plan was coming up short, especially when it comes to so-called “corrective actions” that might be taken when processing problems do occur.

Throughout the warning letter, FDA returns to whether the Florida seafood processor is doing enough to defend against Botulism for products like its canned pasteurized crabmeat.

Botulism is the rare, but often deadly infection caused by Clostridium botulinum bacteria.  The United States only experiences about 100 botulism cases a year, most due to home-canning, cured pork and home, smoked or raw fish, and honey or corn syrup.

“Your corrective action plan for canned, pasteurized crabmeat at the receiving critical control point to control Clostridium Botulinum growth and toxin formation is not appropriate,” the FDA warning letter says.

When holding product because of concern about Botulinum growth and toxin formation, the seafood processor said it would reject and return it.  FDA said that was not good enough because it did not address proper transportation practices by the supplier.

Specifically, FDA said, the plan does not address “appropriate transit temperature.”

“We recommend the discontinued use of suppliers until their transportation practices change and that your firm holds the product until time and temperature exposures can be evaluated,” the warning letter said.

FDA recommended Cemco assess transit temperatures, and come up with a monitoring procedure. It wants the processor to make a “continuous record of transit temperatures.”

“Alternatively, FDA recommends monitoring for the presence of adequate ice or cooling media when products are received on ice or with cooling media,” the warning letter advised.

During the FDA inspection last June, there were enough “serious violations” of seafood HACCP and Current Good Manufacturing Practice regulations to cause the company’s products to be adulterated, the FDA said.

“Accordingly, your Pasteurized Crab Meat, Scombroid-Toxin Forming Species, Tuna, Mahi Mahi, and aqua cultured Sea Bass and Atlantic Salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” FDA said.

The company was given 30 days to respond to FDA with necessary revisions to its HACCP plan.

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