Imported Seafood Safety: Actions Needed to Improve FDA Oversight of Import Alert Removal Decisions
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
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.
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. According to FDA, as of June 2023, the agency developed a Quality Factor Checklist (QFC) to verify standard removal criteria is met prior to removing a firm from an import alert. After the QFCs were implemented, the agency implemented an auditing program in FY 2022 to ensure continued verification of the QFCs on a quarterly basis. Anytime a food firm is removed from an import alert, FDA's foreign inspection planning branch will evaluate the recommended firm to determine appropriate inspectional follow-up, according to FDA. The QFC includes important information such as a root cause analysis conducted by the firm to identify the problems that led to the placement on an import alert and a supervisory review of the checklist. The checklist, however does not include other important information, such as whether the firms were inspected, or its products sampled prior to removal to independently verify the status of the firm under an import alert. To fully implement this recommendation, FDA should develop a process to review the agency activities for all removal decisions to ensure the agency is consistently applying its goals and other important verification activities. In addition, this overall review process could help FDA determine the effectiveness of its checklist and Import Alert Evaluation Program reviews.
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| 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. According to FDA, as of June 2023, the agency is committed to establishing performance metrics, including those for violation rates, recidivism rates, and regulatory actions. The agency plans to design metrics that will enhance its ability to improve the targeting of violative seafood samples entering the country and the use of its resources, among other things. FDA plans to continue making progress on this recommendation but is unable to provide a specific timeline for establishing the recommended performance as it is transforming how FDA's programs and functions are organized and operated. We will continue to monitor FDA actions to implement this recommendation.
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| 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. According to FDA, as of June 2023, FDA still uses its Import Alert Evaluation Program reviews to determine the number of firm establishment identifier merges required; the number of deactivated and major/minor revisions that were completed during the review of import alert content; and the number of discrepancies noted between import alert screening tools in the Compliance Management System compared to those in the Operational and Administrative system for Import Support. These reviews are generally conducted to determine the accuracy and validity of the import alert information FDA tracks in its data systems. FDA also developed a checklist to ensure that all critical elements of the agency's standard operating procedures are met before a firm is removed from an import alert. The reviews and checklist are useful tools for FDA in managing its import alert program but are not performance goals or measures. Performance goals explain the purpose of agency programs and the results including outcomes that they intend to achieve. Performance measures provide organizations with the ability to track the progress they are making toward their mission and goals and provide managers with information on which to base their organizational and management decisions. To fully implement this recommendation, FDA should fully develop measures that align with agency requirements, goals, and expectations. By doing this, FDA would be better positioned to assess how well its import alert activities are supporting the agency in achieving its food safety mission.
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