Fast Facts

FDA ensures that imported seafood is safe to eat. If it suspects that products may violate U.S. laws, FDA can detain them at ports until the violation has been resolved—a process called an import alert.

FDA’s goal is to sample at least one shipment of each product before removing it from alert status. We found that for 274 seafood products that FDA removed from import alerts between 2011 and 2018, FDA did not sample shipments for 95% of these products, and does not have a process to ensure it actually conducts such sampling.

We recommended that FDA establish such a process.

A gloved hand holding a thermometer in raw fish

A gloved hand holding a thermometer in raw fish

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Highlights

What GAO Found

The Food and Drug Administration's (FDA) import alert process for seafood products includes three key components: (1) establishing new import alerts, which inform FDA field staff and the public that the agency has enough evidence that products appear to violate a federal food safety law to detain those products at U.S. ports of entry without physically examining them; (2) placing firms and products on existing import alerts; and (3) removing firms and products from those import alerts when violations are resolved. As of July 3, 2018—the most recent data at the time of GAO's analysis—FDA had 52 active import alerts affecting imported seafood that addressed a wide range of violations of federal law, including the presence of foodborne pathogens, such as Salmonella , or unapproved animal drug residues.

FDA has established audit goals, requirements, and expectations related to sampling and inspections—key activities to support import alert removal decisions—but does not monitor the extent to which it is meeting them. GAO's review of 274 removal decisions from October 1, 2011, through July 3, 2018, found that FDA had supported only a small percentage of its removal decisions by conducting sampling and inspections. For example, FDA has a goal to audit samples from at least one of the shipments used to support each removal decision to ensure the validity of the analysis that a private laboratory performed. However, GAO found that within a year prior to the 274 removal decisions, FDA did not conduct any audits for 260 (95 percent) of the 274 removal decisions. FDA officials said they conducted limited sampling because many import alert removal decisions can be supported by documentary evidence provided by firms. Additionally, for certain violations that indicate a firm failed to meet regulatory or administrative requirements and may pose a public health hazard, an FDA directive establishes a goal for FDA staff to conduct a follow-up inspection within 6 months. However, GAO's review of removal decisions found that for 31of the 32 firms that received such a finding, FDA did not conduct a follow-up inspection before removing them from an import alert. FDA officials said they did not know whether they were meeting their audit goals because the agency does not have a process to monitor the extent to which it is conducting its sampling and inspections. Establishing such a process would provide greater assurance that FDA is conducting its expected level of sampling and inspections to support its removal decisions and has confidence in continued compliance.

FDA has not established performance goals and measures for seafood import alerts—key elements for assessing the effectiveness of programs. Goals explain the outcomes a program seeks to achieve, and measures track progress towards those goals. In February 2019, FDA published a broad plan for the safety of imported food. The plan states that FDA intends to develop performance goals and measures related to imported food safety, but FDA has not established a time frame for doing so. By establishing a time frame and developing such goals and measures, FDA would be better positioned to assess how well its seafood import alert activities are supporting the agency in achieving its food safety mission.

Why GAO Did This Study

Imports account for over 90 percent of U.S. seafood consumption. FDA and the Department of Homeland Security (DHS) both play a role in overseeing imported seafood. FDA is responsible for ensuring the safety of most imported seafood. DHS provides FDA with import data on FDA-regulated products, including seafood. If FDA finds that imported seafood products appear to violate U.S. laws, FDA may place the products, firms, or countries on an import alert.

GAO was asked to review FDA's efforts to use import alerts to ensure the safety of imported seafood. This report, among other things, (1) describes FDA's import alert process for seafood products, (2) examines FDA oversight of key activities to support import alert removal decisions, and (3) examines the extent to which FDA has assessed the effectiveness of its seafood import alerts. GAO reviewed FDA procedures and data, including data on 274 removal decisions, for a non-generalizable sample of seven import alerts selected for a range of violations of federal law. GAO also interviewed FDA officials.

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Recommendations

GAO recommends that FDA (1) establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections, (2) establish a time frame for developing goals and measures for its imported food safety program, and (3) develop goals and measures for seafood import alerts. FDA agreed with GAO's recommendations.

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of 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 1)
Open
FDA agreed with our recommendation. In August 2020, FDA told us that the agency was working to review and modify appropriate sections of its Regulatory Procedures Manual (RPM) to better reflect the importance of foreign suppliers' corrective actions when making decisions to remove a firm from an import alert and identify higher-risk problem areas where more robust information may be needed. In addition, a checklist for import alerts and associated Compliance Management System (database) functionality are under development. In June 2021, FDA stated that it had updated several RPM sections to remove the "goal" number of audit samples that were described as supporting the import alert process. FDA added that, in addition to a review of policies and procedures, the agency had initiated discussions with FDA staff who plan foreign inspections to better assure that firms which have recently been removed from an import alert are also considered for an inspection. To fully implement this recommendation, FDA should develop a process to analyze its import alert data in CMS, FACTS, and OASIS and compare actual performance with planned or expected results to determine if it is meeting its goals and requirements.
Food and Drug Administration The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)
Open
FDA agreed with this recommendation. In August 2020, FDA told us that it had published some performance metrics and plans to develop additional performance measures and outcome indicators for imported food safety, to support FDA's Strategy for the Safety of Imported Food (Strategy). In June 2021, FDA stated that it had developed four measures that track the compliance of foreign suppliers with FDA food safety requirements standards. FDA added that it is also working with the Centers for Disease Control and Prevention to establish methods to estimate the impact of increased compliance and enhanced oversight of foreign suppliers on foodborne illness from imported foods in the United States. FDA said it also continues to examine additional performance measures and metrics for imported food safety to support FDA's Strategy for the Safety of Imported Food. To fully implement this recommendation, FDA should establish a timeframe for developing performance goals and measures for its imported food safety program.
Food and Drug Administration The Commissioner of 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. (Recommendation 3)
Open
FDA agreed with this recommendation. In June 2021, FDA stated that it is still reviewing the Import Alert Effectiveness Program (IAEP) and plans to complete 20 IAEP reviews to verify the effectiveness of the import alerts. In addition, FDA identified a performance goal and corresponding performance measures specific to IAEP, which covers all FDA-regulated imported products. FDA continues to explore business processes to more easily quantify goals and measures to support the overall imported food strategy including FDA's oversight of imported seafood. To fully implement this recommendation, FDA should develop performance goals and corresponding performance measures specific to seafood import alerts.

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