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1 1 (January 25, 2023)

handle is hein.crs/govekjd0001 and id is 1 raw text is: Congressional S£ Research Service FDA's Independent Evaluation of Its Food Safety Programs January 25, 2023 The U.S. Food and Drug Administration (FDA) has primary responsibility for the safety of about 78% of the U.S. food supply. The combined efforts of the food industry and government regulatory agencies often are credited with making the U.S. food supply among the safest in the world. In 2010, the 111th Congress passed the Food Safety Modernization Act to improve FDA's ability to minimize incidences of foodbome illness. Nevertheless, the Centers for Disease Control and Prevention (CDC) report that each year about 48 million people become sick from contaminated food in the United States with an estimated 128,000 hospitalizations and 3,000 deaths. Major foodbome illness events, such as the 2020 leafy greens outbreak and 2022 powdered infant formula incident, have heightened public and media scrutiny of FDA's Human Foods Program and magnified congressional interest in foodbome illness outbreaks. An April 2022 Politico report cited FDA failures to safeguard U.S. food supplies and organizational dysfunction. Recent Congresses have held multiple hearings and introduced several bills addressing food safety (see, for example, the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies' hearing on FDA and food safety, H.R. 8358, and S. 2958). In response to increased media and congressional scrutiny, FDA Commissioner Dr. Robert Califf requested that the Reagan-Udall Foundation-an independent organization created by Congress to advance FDA's mission-convene an independent expert panel to comprehensively evaluate FDA's Human Foods Program. The Reagan-Udall Foundation published its evaluation report in December 2022. It describes numerous shortcomings within the agency's organizational culture, leadership structure, access to resources, and regulatory authorities. The report makes recommendations for improvement, some of which may require congressional action if they are to be implemented. Reagan-Udall Evaluation The commissioner requested the scope of the panel's evaluation include the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), and relevant parts of the Office of Regulatory Affairs (ORA). A summary of the panel's key findings follows. Congressional Research Service https://crsreports.congress.gov IN12083 CRS INSIGHT Prepared for Members and Committees of Congress

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