A seafood processing facility in Kentucky is on notice from the Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Officials from the FDA’s Division Office of Human and Animal Foods inspected the Milton, KY, location of MC Fish Co. March 20-23. According to an April 18 warning letter recently made public by the FDA, the facility’s paddlefish and paddlefish roe may be injurious to health because they were prepared, packed or held under insanitary conditions.

The report cited several significant violations in relation to the seafood HACCP regulation for fish or fishery products:

The firm failed to conduct, or have conducted, a hazard analysis for each kind of fish and fishery product that they produce, to determine whether there are food safety hazards that are reasonably likely to occur. The firm’s HACCP plans “for paddlefish meat and paddlefish roe do not list the food safety hazard of allergens. The allergen hazard is reasonably likely to occur because paddlefish is a fin-fish, one of the eight major food allergens. “

The firm failed to have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, and specifically, the firm’s HACCP plan for paddlefish roe lists a critical limit, “SALT/ROE RATIO (concentrations),” at the salting critical control point that is not adequate to control the growth of Clostridium botulinum.

The firm did not follow the monitoring, record keeping, and verification procedures and frequencies listed in their HACCP plan for paddlefish roe.

The firm failed to monitor the thermometer in their packaged roe refrigerator for their refrigeration critical control point to control Clostridium botulinum.

“Your monitoring requirement includes two visual checks per day to ensure the temperature remains at or below 38 degrees F,” the warning letter stated. “… you no longer conduct and record daily checks, … the continuous monitoring chart only reports temperatures in Celsius and you stated you did not know what your critical limit would be in Celsius.”

According to the warning letter, the firm implemented a continuous temperature monitoring device for the paddlefish roe refrigerator in January 2016, however, their HACCP plan for paddlefish roe was not updated to reflect this change.

Under FDA regulations, all facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.

The FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, the Hazards Guide, “provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products.”

The Hazards Guide states that, “This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies. The guidance will help consumers and the public generally to understand commercial seafood safety in terms of hazards and their controls.”

The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations. FDA has not yet posted a closeout letter on the case.