The FDA inspected the Crystal Cove Seafood Corporation in Floral Park, New York last Oct. 13 to assess the compliance by the company with US seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
The trading and importing company was found importing various fish and fishery products from a facility owned by Ba Hai located in Vietnam.
FDA said the HACCP plan of Ba Hai for scombroid species of fish contains ‘serious deviations’ from requirements, enough so that its frozen scombroid species of fish are considered contaminated.
Scombroid fish poisoning is a toxic reaction to decomposing scombroid fish, such as mackerel, tuna, bonito, kahawai and butterfly kingfish— all of which have dark flesh. Occasionally other fish species are involved.
Scombroid fish contain a chemical called histadine. Bacteria multiply in fish stored in warm conditions (>15C) and turn the histadine into scombrotoxin. The main component of scombrotoxin is histamine, which is responsible for the symptoms of scombroid poisoning.
Cooking the fish does not reduce histamine levels even though the causative bacteria have been destroyed.
The FDA requires fish to have a histamine level of less than 50 mg/kg; a level of 200 mg/kg or above is considered hazardous.
The warning letter says Ba Hai should keep its product “out of commerce until the cause of the deviation is corrected at the Receiving, Preserve (Anneal), and Pre-Chilled critical control points to control scombrotoxin formation.”
FDA also warns that if it finds the response of Ba Hai inadequate, it may take further action including refusing to admit the scrombroid species of fish import to the US. This includes the possibility the products could be detained at the US border without physical examination.
In addition to providing Ba Hai with internet access to the 4th Edition Hazards Guide, the FDA warning letter also provides detailed instruction on how the company might go about correcting the specific deviations, including instructions for harvesting and holding on fishing vessels prior to processing.
The Vietnam Association of Seafood Exporters and Producers lists Ba Hai Company Limited as using HACCP as a quality control system. The company is one of the leading seafood processors in Vietnam and exporters of frozen tuna, treated tuna loin, ribbon fish, shell swimming crabs, and other fishery products.
The privately held Crystal Cove Seafood Corp. engages in trading and importing frozen seafood items for wholesalers, traders, retail and restaurant chains, and processors primarily in the US.
It was founded in 1980 and is headquartered in Floral Park, New York.