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FDA Falling Short on Foreign Food Facility Compliance Mandate

Posted March 11, 2015

The U.S. General Accountability Office (GAO), recently released findings of its audit of the Food and Drug Administration’s (FDA) activities related to the inspection of foreign food facilities. In 2010, GAO examined the FDA’s foreign offices and found that they faced challenges in carrying out their activities due to an increasing workload and other factors. In this follow-up report, GAO found that the agency is not keeping pace with the number of foreign inspections mandated by the Food Safety Modernization Act (FSMA).

Under FSMA, FDA is supposed to inspect at least 600 foreign food facilities in 2011 and, for each of the next 5 years, inspect at least twice the number of facilities inspected during the previous year. According to this estimate, the agency should have inspected 4,800 facilities in 2014, but the GAO found that it only conducted 1,323 inspections this past year. FDA officials told auditors that they do not plan to meet the FSMA mandate because of funding, and moreover, they question the usefulness of conducting that many inspections.

However, FDA has not conducted an analysis to determine whether the number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food. “Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate,” the GAO stated.

GAO recommended in 2010 that FDA develop performance measures that can be used to demonstrate the offices' contributions to imported food safety. To date, this recommendation has not been acted upon, but the FDA has apparently initiated a review to determine how to better reflect the value of the foreign offices in the agency-wide performance systems. GAO notes that until the offices' contributions are captured, FDA will have less information to effectively measure their progress toward meeting agency goals.

The report notes that as of October 2014, almost half of FDA’s approved foreign office positions were vacant, and suggests that a plan would help make sure that the agency recruits and retains staff with the necessary experience and skills.