Background

The Food and Drug Administration is not following up on the vast majority of the warning letters it issues regarding the safety of imported seafood, according to a new report from the Government Accountability Office.

The FDA is responsible for ensuring the safety of most imported seafood and relies, in part, on inspections of importers’ facilities and processors’ foreign facilities to ensure compliance with federal law. If significant violations are identified , such as firms not identifying food safety hazards likely to occur during processing, the FDA can issue a warning letter. The FDA said warning letters are its primary means of getting firms to voluntarily comply with food safety laws and regulations.

The GAO analyzed 167 warning letters the FDA issued on imported seafood from Jan. 1, 2014, through March 11, 2019, and found that FDA did not consistently follow key procedures or meet key goals for its warning letter process. For example, when the FDA issues a warning letter based on significant inspection violations it has a goal to conduct a follow-up inspection within six months to determine whether the violations have been corrected. However, a year after the end of the GAO’s review period the FDA had met this goal for only 11 percent of such warning letters. Another 45 percent saw inspections conducted more than six months later while no inspections had been done for 44 percent.

Similarly, the GAO said, the FDA does not have a monitoring process that allows it to determine whether imported seafood warning letters consistently follow procedures and meet goals, nor has it established performance goals and corresponding measures to assess the effectiveness of the warning letter process.

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