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Courtesy of NAA:

In 2019, the United States imported approximately 6.3 billion pounds of seafood from approximately 140 countries. More than 90 percent of seafood products consumed in the United States are imported, and over half of these imports come from aquaculture. Some fish in these countries can have high rates of bacterial infections, leading those farmers to treat them with drugs, such as antibiotics and antifungal agents, to increase their survival rates. Drugs not used in compliance with US regulations can cause cancer or allergic reactions. The Food and Drug Administration (FDA) ensures that imported seafood is safe to eat. If companies violate food safety regulations and pose a public health risk, FDA may send them warning letters.

The US Government Accountability Office (GAO) was asked to review FDA efforts to use warning letters to ensure the safety of imported seafood. Their report examined the extent to which FDA (1) ensures it is following key procedures and meeting key goals for its warning letter process for imported seafood and (2) assesses the effectiveness of its warning letters in ensuring the safety of imported seafood. GAO reviewed FDA procedures and data and interviewed FDA officials.

What GAO Found
The Food and Drug Administration (FDA) issues warning letters for food safety violations that could pose a risk to public health. According to FDA, warning letters are its primary means of getting firms to voluntarily comply with food safety laws and regulations. GAO analyzed 167 imported seafood warning letters that FDA issued from January 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 FDA issues a warning letter based on significant inspection violations, the agency has a goal to conduct a follow-up inspection within 6 months of the date the warning letter was issued. Of the 167 warning letters GAO reviewed, 125 were based on significant inspection violations. FDA met its 6-month goal for 14 (11%) of these 125 letters. For 56 (45%) of these letters, FDA conducted a follow-up inspection more than 6 months after the warning letter was issued—on average, about 2 years. For the remaining 44%, FDA had not conducted a follow-up inspection, as of March 11, 2020.

Recommendations
GAO recommends that FDA (1) establish a process to monitor whether the agency is following the procedures and meeting the goals established for its warning letter process for imported seafood, and (2) develop performance goals and measures to assess how effective warning letters are at ensuring the safety of imported seafood. FDA agreed with GAO’s recommendations.

To read the full report and to track whether FDA implements the GAO recommendations, click here.