Imported Seafood Safety:

Actions Needed to Improve FDA Oversight of Import Alert Removal Decisions

GAO-20-62: Published: Nov 6, 2019. Publicly Released: Dec 6, 2019.

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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

Multimedia:

Additional Materials:

Contact:

Steve D. Morris
(202) 512-3841
morriss@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

What GAO Recommends

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.

For more information, contact Steve D. Morris at (202) 512-3841 or morriss@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: FDA stated that it agrees that developing metrics and monitoring the import alert removal process is necessary and that these efforts should be guided by the analysis of available data. FDA also stated that it plans to develop goals for its auditing process to ensure audit sampling targets products of higher public health concern and provides the agency support to guide decisions to release individual shipments that have been detained as a result of an import alert. FDA further stated that it intends to enhance its case management system to include checklists for FDA reviewers who process petitions for removal from import alerts to better document that all necessary information is present and has been evaluated to support the removal decision. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  2. Status: Open

    Comments: FDA stated that the agency is developing performance measures and outcome indicators for imported food safety to help support the agency's overall goal of reducing the incidence of illness and death attributable to preventable contamination of FDA regulated foods. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

    Recommendation: The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  3. Status: Open

    Comments: FDA stated that the agency will use the results of its import alert effectiveness program to develop metrics to demonstrate the effectiveness of the program and its use of import alerts. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

 

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