Seafood processing companies in Wisconsin, Colorado, and California were on the receiving end of warning letters made public this week by the U.S. Food and Drug Administration (FDA).
In Wisconsin, the Lake Superior Fish Company on June 1 was warned about “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation” at its processing facility located in Superior.
“Accordingly, your pickled herring and air-packed, ready-to-eat smoked fish products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the FDA warning letter said.
FDA said Lake Superior Fish Company “must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).
“However, your firm does not have a HACCP plan for ready-to-eat Pickled Herring to control the food safety hazards of scombrotoxin (histamine) formation and pathogen growth. You do not have a HACCP plan for ready-to-eat smoked fish including Smoked Lake Herring (Cisco and/or Tullibee) to control the hazard of pathogen growth.”
Also released this week was a May 27 warning letter to Denver-based Italco Food Products, Inc. The Colorado seafood processing company was told its “vacuum packaged smoked salmon, smoked trout, and pickled seafood salad in oil 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 Italco Food Products “must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).
“However, your firm does not have a HACCP plan for vacuum packaged smoked salmon, smoked trout, and pickled seafood salad in oil to control the hazard of pathogen growth and toxin formation from the growth of Clostridium botulinum.”
The Denver company responded last Feb. 23 to FDA’s Form 483 inspection report.
“Our review of the information provided in that response reveals that it is inadequate,” FDA said in the warning letter. “While you state that you will begin the HACCP program, you have not, as of this time, provided a HACCP plan (or plans) to address the hazards and controls associated with the above mentioned products.”
The third warning letter involving a seafood processor came in California where on May 28 American Sea Food Company Inc. was advised it had serious deviations from seafood HACCP regulations.
“Accordingly your scombroid-forming fishes are adulterated, in that these fishes have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby it may have been rendered injurious to health,” FDA told the San Diego fish processor.
The company has provided FDA with a new HACCP plan along with two letters responding with further information. However, FDA says American Sea Food’s “scombroid-forming fish continue to be adulterated.”
It says American Sea Food: “must have a HACCP plan that at a minimum, lists critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3 (c) as the ‘maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.'”
American Sea Food’s “undated HACCP plan for ‘Fresh and Frozen Tuna,’ received on April 13, 2010, does not list adequate critical limits at the Receiving critical control point (CCP) to ensure that scombroid species received directly from the harvest vessel have been handled properly in order to control histamine formation.”
FDA says the fish company is occasionally the primary processor of tuna that is received directly from fishing vessels. It says when that happens; the company must make sure the fish are kept at temperatures below 40 degrees F.
“In addition, we note that your firm processes other scombroid species fish, in addition to tuna, such as Mahi-Mahi” FDA wrote. “Your HACCP plan should reflect all your scombroid fish species.”
FDA also called for better monitoring procedures from American, noting that last Feb. 1 the company received Tuna, Albacore, and Mahi-Mahi without checking the temperature or adequacy of ice on receipt.
“You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CPR 123.6(c)(4). However, your film’s HACCP plan for ‘Fresh and Frozen Tuna,’ received on April 13, 2010, lists a monitoring procedure at the ‘Storage of fresh tuna in the plant’ critical control point that is not adequate to control scombrotoxin formation,” the letter continued.
FDA also called for better sanitation control record keeping.
Finally, FDA made it clear the company should take the warning letter seriously. “We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. In addition, we may not provide certificates to your film for export of your products to European Union (EU) countries if you do not correct these deviations,” FDA warned.
The three companies were each given 15 working days to respond to FDA’s concerns.