FDA needs to adequately staff its foreign offices – where 44 percent of positions were vacant as of October 2014 — to fulfill its inspection mandate under the Food Safety Modernization Act (FSMA), according to a newly released report by the Government Accountability Office (GAO).
Under FSMA, FDA was mandated to inspect at least 600 foreign food facilities in 2011 and, for each of the next five years, to inspect at least twice the number of facilities inspected during the previous year. However, GAO explains, the agency is not currently keeping pace with that FSMA requirement. FDA officials told GAO’s researchers they do not plan to meet the FSMA mandate because of funding. The officials also “questioned the usefulness of conducting that many inspections,” GAO says.
GAO conducted an in-depth review of FDA’s foreign office operations in Canada, China, and Mexico. The locations were selected based on an analysis of the volume of food imports, the percentage of food imports refused at the border, and the number of food facility inspections for fiscal year 2013, among other factors. The review included visits to FDA’s offices in Beijing and Guangzhou, China, and in Mexico City.
This is not the first time GAO has looked into FDA’s overseas staffing. In 2010, the oversight arm of the U.S. Congress recommended that FDA develop a strategic workforce plan for its foreign offices to help ensure it recruits staff with the necessary experience and skills. “GAO continues to believe that such a plan for the foreign offices is critical to FDA’s ability to address staffing challenges,” the new report states.
“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,” GAO says.
I believe it would be very helpful to fully staff all FDA overseas offices. But as a practical matter, I also believe direct inspection by FDA of overseas food facilities is not the key to improving the safety of food imported into the United States. Certified third party audits, the Foreign Supplier Verification Program, along with outreach and education efforts to stakeholders are likely to play a far more important role. As final regulations begin to roll out this year, FDA’s overseas offices will have their hands full simply explaining those new regulations.