The U.S. Food and Drug Administration is issuing a draft Compliance Policy Guide (CPG) that revises the current CPG Sec. 540.525 on decomposition and histamine in fish and fishery products. This draft CPG provides guidance to assist the FDA in addressing adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing. The draft CPG also increases consumer protections related to histamine poisoning by lowering the levels of histamine in fish at which the FDA indicates that it may take action.
Because of the composition of the muscle tissue in certain finfish species, such as tuna, mahi-mahi, and sardines, decomposition after the fish die can produce histamine, which can threaten human health. Unless properly chilled after death and maintained in a chilled state, or otherwise treated or processed to prevent further microbial activity, histamine can accumulate in the edible muscle of these fish. Once formed, histamine cannot reliably be removed by washing, freezing, or heating. Poisoning happens within a few minutes to several hours after ingestion of the food that contains high levels of histamine. However, when properly harvested and handled, these fish have little to no detectable histamine. Histamine poisoning or Scombrotoxin fish poisoning continues to represent the highest number of illnesses associated with finfish in the United States.