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: Department of Health and Human Services: Food and Drug Administration
Status: Open
Comments: FDA agreed with our recommendation. In August 2020, FDA told us that the agency is working to review and modify appropriate sections of its Regulatory Procedures Manual 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. According to FDA, the agency is also working to refine internal communications to better assure that firms which have recently been removed from an import alert are also considered for an inspection. Additionally, in November 2019, FDA published a Notice of Proposed Rulemaking on accreditation of laboratories that conduct food testing to support removal from import alert and other purposes. 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: Department of Health and Human Services: Food and Drug Administration
Status: Open
Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency has 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 addition, after publishing these initial metrics for the Strategy, the agency will develop additional performance metrics. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. 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: Department of Health and Human Services: Food and Drug Administration
Status: Open
Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency remains committed to developing additional performance goals and measures for its imported food safety program. FDA is still reviewing the Import Alert Effectiveness Program and will consider metrics, as appropriate, based on the outcome of that review. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.
