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GAO-25-107571 1 (2025-01-08)

handle is hein.gao/gaorid0001 and id is 1 raw text is: Why This Matters Key Takeaways The Food and Drug Administration (FDA) is responsible for ensuring the safety of nearly 80 percent of the nation's food supply, including fruits, vegetables, processed foods, dairy products, and most seafood. Although the U.S. food supply is generally considered safe, foodborne illness remains a common and costly public health problem. Each year, foodborne illnesses sicken tens of millions of Americans. Of these, tens of thousands are hospitalized and thousands die, according to the most recent estimate from the Centers for Disease Control and Prevention. Foodborne illnesses may result from multistate outbreaks from pathogens in foods regulated by FDA. For example, in October 2024, the nation experienced an outbreak of the dangerous foodborne pathogen E. coli that, as of December 3, 2024, had sickened at least 104 people and caused one death. FDA worked to identify the source of that outbreak and determined it likely was slivered onions in burgers sold by a major national fast-food chain. A separate outbreak of the foodborne pathogen Listeria occurred earlier in 2024 when 23 people were hospitalized and two died. In that case, an FDA investigation resulted in a manufacturer recall of cheese products that had been contaminated at a production site in California. We have long reported on FDA's efforts to safeguard the nation's food supply. Improving federal oversight of food safety has been on GAO's High-Risk List since 2007. To accomplish its food safety mission, FDA uses a range of tools, including conducting routine surveillance inspections of domestic and foreign food facilities. Such inspections are intended to monitor a facility's compliance with regulatory requirements and serve as a proactive tool aimed at preventing food safety problems rather than reacting to outbreaks after they happen, according to agency officials. The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, includes targets for the domestic and foreign food inspections that FDA is to conduct annually. We performed our work at the initiative of the Comptroller General to assist Congress with oversight of FDA's efforts to conduct food safety inspections. This report provides information on FDA's role in conducting domestic and foreign food safety inspections and examines how FDA inspections compare with mandated targets established by FSMA, what challenges FDA faces in conducting food safety inspections, and how FDA assesses the results of its inspection efforts. * FDA has not met FSMA's mandated targets for domestic food facility inspections since fiscal year 2018. In addition, FDA has consistently fallen short of meeting its annual targets for foreign food facility inspections. While Page 1 GAO-25-107571 FDA Food Safety Inspections Page 1 GAO-25-107571 FDA Food Safety InspeGfions

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