March 14, 2022
In response to a request from stakeholders, the FDA is reopening the comment period for the draft Compliance Policy Guide (CPG) entitled “Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine” that was published on December 27, 2021 (86 FR 73295). This draft CPG, when finalized, will assist the FDA in addressing adulteration associated with decomposition and histamine identified during surveillance sampling and testing.
The FDA is reopening the comment period to allow additional time for stakeholders to develop and submit data, other information, and comments for the draft CPG. The original comment period closed on February 25, 2022; the new comment period will close on April 13, 2022. Stakeholders will now have an additional 30 days to comment.
To submit comments electronically to the docket, visit Docket No. FDA-2021-D-0367.
For additional information:
Original Constituent Update
December 23, 2021
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.
The FDA is updating two guidance levels for the presence of histamine in these fish. If samples have 35 parts per million (ppm) or more histamine (lowered from 50 ppm), the FDA may consider the fish to be adulterated because they are decomposed and/or produced under insanitary conditions. At 200 ppm (lowered from 500 ppm), the FDA may consider the fish to be adulterated based on the presence of a deleterious substance (histamine) which may render them injurious to human health. The CPG notes that elevated histamine levels can be prevented in fish by adherence to Current Good Manufacturing Practices and Hazard Analysis Critical Control Point (HACCP) principles required by FDA’s Fish and Fishery Products regulation by each processor in the distribution chain.
The updates to this CPG bring the agency’s regulatory position and thinking in line with current science and increase public health protection.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Submit comments electronically on Regulations.gov to docket number FDA-2021-D-0367.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number FDA-2021-D-0367.
For Additional Information
- Federal Register Notice announcing the Draft CPG
- CPG Sec 540.525 DRAFT: Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)
- Manual of Compliance Policy Guides
*Fish species associated with histamine formation and scombrotoxin (histamine) fish poisoning are listed in the June 2021 FDA’s Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition June 2021, Chapter 3, Table 3-2 Good Manufacturing Practices: 21cfr 117 & 21cfr 123