GAO critical of FDA’s foreign food inspections

The congressional watchdog said FDA’s foreign offices are not keeping pace with the Food Safety Modernization Act mandate.    A congressional watchdog agency’s report said the Food and Drug Administration has failed to meet its mandate to conduct a certain number of safety inspections of overseas facilities that export food to the United States.
   The mandate, which is part of the Food Safety Modernization Act, required the FDA to inspect at least 600 foreign food facilities starting in 2011 and at least twice that number for the next five years thereafter. 
   “FDA is not currently keeping pace with the FSMA mandate,” the Government Accountability Office said.
   GAO said FDA officials told its staff that “they do not plan to meet the FSMA mandate because of funding, and they question the usefulness of conducting that many inspections.” 
   However, the FDA has failed to conduct a proper analysis to determine the actual number of overseas facility inspections that would be sufficient to ensure food safety. “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,” GAO said.
   FDA first set up its overseas inspection offices in 2008. In 2010, GAO recommended FDA develop performance measures that can show these offices’ contributions to the safety of food imports. 
   “FDA has initiated a review to determine how to better reflect the value of the foreign offices in the agency-wide performance systems,” GAO said. “Until the offices’ contributions are captured, FDA will have less information to effectively measure their progress toward meeting agency goals.”
   In 2010, GAO also recommended the agency develop a plan to recruit and retain staff for its foreign offices. GAO said it “continues to believe that such a plan for the foreign offices is critical to FDA’s ability to address staffing challenges, especially since 44 percent of foreign office positions were vacant as of October 2014.”
   For its report on the FDA’s overseas facility inspection program, GAO said it reviewed documentation from the foreign offices, visited offices in China and Mexico, and interviewed agency officials, overseas regulators and stakeholders.
   GAO recommended FDA complete its analysis to determine the actual number of foreign food inspections that would be sufficient to ensure safety equality between imported and domestically produced foods. FDA agreed with the GAO’s recommendations.