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GAO recommends FDA improve oversight of import alert removal decisions

The Government Accountability Office (GAO) is out with a new report suggesting the Food and Drug Administration (FDA)  needs to up its game when it comes to imported seafood.  At issue is the FDA’s oversight of import alert removal decisions for seafood arriving in the United States.  Imports account for 90 percent of seafood consumption in the United States.
The GAO report makes three recommendations:
Recommendation 1- The Commissioner of the FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS.
Recommendation 2- The Commissioner of the FDA should establish a time frame for developing performance goals and measures for its imported food safety program.
Recommendation 3- The Commissioner of the FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts.
The Department of Health & Human Services, responding on behalf of the FDA, concurred with all three recommendations. “We find the recommendations to be timely and helpful in advancing the Food and Drug Administration’s Strategy for the Safety of Imported Food, issued in February 2019, and the new Import Alert Effectiveness Program,” comments provided by the Office of the H&HS Secretary said. “FDA will use GAO’s recommendations on performance goals, measures, and monitoring to further strengthen the safety of imported seafood and other FDA-regulated food imports.”
GAO is the audit, evaluation, and investigative arm of Congress. It studied seafood imports at the request of Rep. Rosa L. DeLauro and four U.S. Senators: Richard Blumenthal, Dianne Feinstein, Patty Murray, and Elizabeth Warren.
GAO said the Members of Congress asked for a review of the FDA’s efforts to use import alerts to ensure the safety of imported seafood.



“This report (1) describes FDA’s import alert process for seafood products, (2) examines FDA’s oversight of key activities to support its import alert removal decisions, (3) examines the extent to which FDA coordinates with DHS to help ensure firms comply with seafood import alerts, and (4) examines the extent to which FDA assesses the effectiveness of its seafood import alerts in achieving the agency’s food safety mission,” GAO says.



The United States is the world’s second-largest importer of seafood, importing from approximately 140 counties. GAO reports 6.3 billion pounds of seafood imported in 2017, up from 5.8 billion pounds three years earlier.
Except for catfish, FDA is responsible for the regulation of imported seafood. The Department of Homeland Security (DHS) provides import data to the FDA, which includes tracking all the incoming seafood. When FDA spots seafood imports that appear to violate U.S. laws, it has to power to place products, firms, or entire counties on an import alert.
Rep. DeLauro and the requesting Senators wanted GAO to examine how FDA uses import alerts to ensure the safety of imported seafood. The removal of import alerts and their effectiveness were also part of the GAO study.
The FDA had imposed 52 active import alerts affecting imported seafood at the time GAO conducted its analysis.   Imported seafood was the subject of those imports for a wide range of violations, according to the GAO report, including the presence of foodborne pathogens, such as Salmonella, to the presence of unapproved animal drug residues.
GAO found the FDA has established audit goals including requirements and expectations related to sampling and inspections to support the removal of import alerts but does not monitor the extent to which it is meeting the goals. GAO examined 274 removal decisions that occurred from Oct. 1, 2011, to July 3, 2018; finding only a small percentage were removed through sampling and inspections.
 
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