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GAO Report: FDA Not Planning to Meet FSMA Mandates

The Government Accountability Office (GAO) released a report last week stating that the U.S. Food and Drug Administration (FDA) could do more to ensure that food being imported into the U.S. is safe.

This new report is a followup to a 2010 study in which the GAO found that the FDA’s foreign offices were strained by mounting workloads and other factors that might have jeopardized the safety of imported food. Five years later, the FDA is still having trouble keeping up with foreign inspections required by the Food Safety Modernization Act (FSMA) signed into law in 2011 by President Barack Obama––partially due to staffing issues. Nearly half (44 percent) of foreign office positions were vacant as of October 2014, according to the report.

FSMA requirement:
Within the first year of the act’s passage, the FDA must inspect 600 foreign food facilities. Thereafter––for the next 5 years––the agency must inspect at least twice the number of food facilities inspected during the previous year.

GAO findings:
The number of required inspections was more than satisfied in 2011––the same year that the FSMA took effect. Since then, the number of inspections completed annually has fallen short. In 2014 alone, more than 3,400 inspections were never conducted.

The GAO report states that the FDA “is not planning to meet” mandates required within the FSMA and the agency is raising doubts that the high number of required inspections is actually beneficial in any way.

The GAO has suggested that the FDA perform some level of analysis––along with performance goals and metrics––to determine what a more appropriate number of inspections per year might be so that new legislation can be presented to Congress.