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) |
FDA agreed with our recommendation. As of April 2024, the agency uses its Import Alert Evaluation Program and Quality Factor Checklist (QFC) as a systematic process for the regular review of all import alerts. 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 independently verify the status of the firm under an import alert. According to FDA, the agency conducts quarterly audits to verify consistency in the process for removal decisions for seafood import alerts and ensure staff follow set criteria for any removal decisions. FDA also stated that over the first year of implementation in fiscal year 2022, no issues were identified and no deviations were noted. Finally, the agency's checklist for quarterly audits ensure that all critical elements of FDA's standard operating procedures are met before a firm is removed from an import alert, according to FDA. Based on our review of FDA's documentation and statements, the evaluation program including quarterly reviews and checklist are useful tools for FDA in managing its import alert program and serves as its 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.
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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) |
FDA agreed with this recommendation. According to FDA, as of April 2024, the agency has continued to work on identifying performance goals, measures, and timelines, while concurrently working on plans for the proposed reorganization of the Human Foods Program (HFP). The HFP includes an Office of Strategic Programs designed to unify the strategic planning, performance management, and evaluation functions for program and field activities. According to FDA, further assessment and development of performance metrics for the program, including import safety, would be among the early priorities of the Office of Strategic Programs. 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) |
FDA agreed with this recommendation. According to FDA, as of April 2024, the agency uses available risk management tools, procedural assurances, and regulatory follow-up as measures to assess a foreign firm's compliance instead of performance measures specific to seafood import alerts. FDA has an overall performance goal and specific measures for compliance related to import alerts. According to FDA, the agency has many risk management tools that provide the agency with oversight of imported food products such as Importer Seafood HACCP (Hazard Analysis and Critical Control Point) inspections, the Foreign Supplier Verification Program, as well as examinations and sampling. Moreover, FDA has instituted the Import Alert Effectiveness Program (IAEP) program to ensure that import alerts are accurate and effective which the agency described as its first line of defense against preventing the importation of known violative products. According to FDA, the agency's annual performance goal is to complete a certain number of IAEP reviews each year, and the measures for assessing IAEP effectiveness during repeated reviews are: (1) number of Firm Establishment Identifier (FEI) merges observed in Import Alert Firm Listings, (2) number of deactivated and major/minor revisions during the review of Import Alert Content, and (3) number of discrepancies compared to the Import Alert Comparison Report and the information in the Import Alert electronic screening tool. While FDA does not have specific performance goals and measures for seafood import alerts, the agency is able to track data on its overall goals and measures for import alerts and report out data related to seafood import alerts in its Compliance Management System. For example, according to FDA, since fiscal year 2022 there were 19 IAEP reviews specifically related to seafood import alerts. In fiscal year 2023, 7 of 92 FEI merges completed were related to seafood import alerts. FDA also provided fiscal year 2023 data on deactivations (20), major revisions (48), and minor revisions (42). In fiscal year 2023, 267 of 4,881 identified screening discrepancies were related to seafood import alerts. Based on information provided by FDA, the agency has met the intent of the recommendation on performance goals and measures.
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