FDA Oversight of Import Alert Removals Needs Improvement, GAO Says

The Food and Drug Administration’s oversight of decisions to remove seafood products and firms from its import alerts needs further improvement, according to a recent Government Accountability Office report. The FDA agreed with the assessment and said it plans to take steps in that direction.

For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

According to the GAO, the FDA’s 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 import alerts when violations are resolved. As of July 3, 2018, the FDA had 52 active import alerts affecting seafood.

The GAO found that while the FDA has established audit goals, requirements, and expectations related to sampling and inspections, which are key activities supporting import alert removal decisions, it does not monitor the extent to which they are met. For example, while the 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, it did not conduct any such audits for 95 percent of the 274 removal decisions taken from Oct. 1, 2011, through July 3, 2018. In addition, the FDA did not conduct a follow-up inspection of 31 of 32 firms that failed to meet regulatory or administrative requirements before removing them from import alerts.

The GAO also determined that (a) the FDA and U.S. Customs and Border Protection have yet to develop mechanisms to share information regularly and proactively to help detect the evasion of import alerts and (b) the FDA has not established performance goals and measures for seafood import alerts or a time frame for doing so.

According to the GAO, the FDA agreed with the report’s recommendations and stated that it plans to take the following measures.

  • develop goals for its auditing process to ensure that sampling targets products of higher public health concern and provides support to guide decisions to release individual shipments detained as a result of an import alert
  • 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
  • develop performance measures and outcome indicators for imported food safety to help support the overall goal of reducing the incidence of illness and death attributable to preventable contamination

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on December 11, 2019.

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