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FDA Needs to Review Foreign Food Inspections, Performance of Overseas Offices, GAO Says

Thursday, March 05, 2015
Sandler, Travis & Rosenberg Trade Report

The Government Accountability Office reported to Congress recently that the Food and Drug Administration needs to take additional actions to help its foreign offices ensure the safety of imported food.

The report points out that the FDA is not inspecting the number of foreign food facilities required by the Food Safety Modernization Act. FSMA required the FDA to inspect at least 600 foreign food facilities in 2011 and to at least double the number of facilities inspected for each of the next five years. However, the FDA has not kept pace with this mandate and is planning to conduct only 1,200 foreign facility inspections through 2016. Agency officials have cited limited resources as the primary reason but have also questioned the usefulness of conducting the number of inspections required by law. However, the report states that the FDA has not conducted an analysis to determine how many inspections are sufficient to ensure the comparable safety of imported and domestic food and that without such an analysis the agency is not in a position to request a change in the mandate if appropriate.

FDA officials responding to the GAO report agreed with the recommendation to conduct this analysis and recognized that foreign inspections provide accountability for inspected firms, incentives for them to comply with U.S. import requirements and intelligence about foreign food safety practices. However, officials added that foreign inspections will not, in and of themselves, ensure the comparable safety of imported and domestic food and that the FDA is expanding its collaborations with foreign governments to assist in this goal.

The report also states that the FDA’s performance measures do not fully capture the contributions that foreign offices say they are making to the safety of imported food, five years after the GAO recommended the development of such measures. The FDA has initiated a review to determine how to better reflect the value of its foreign offices in the agency-wide performance systems but has not implemented new performance measures of determined when this review will be completed.

Finally, the report notes, the FDA has not followed through on a 2010 GAO recommendation to develop a strategic workforce plan to help ensure that it recruits and retains staff for its foreign offices with the necessary experience and skills. The GAO continues to believe that such a plan is critical to the FDA’s ability to address staffing challenges, especially since 44 percent of foreign office positions were vacant as of October 2014.

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