Durbin & Blumenthal Request Review Of FDA's Efforts To Protect The Nation's Food Supply & Prevent Outbreaks Of Foodborne Illness

Letter

Dear Mr. Dodaro,

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), which represents thelargest expansion and overhaul of U.S. food safety lawsince the 1930s, was signed into law in January 2011. Among other things, FSMA shifted FDA regulators' focus from responding to foodborne illness outbreaks to trying to prevent them from occurring in the first place. According to FDA, the agency has finalized nine major rules to implement this comprehensive act. Each rule specifies actions that farmers, food manufacturers, importers, or others must take at certain points along the food chain -- from production to sale -- to prevent contamination.However, we remain concerned that FDA's oversight of ournation's food supply continues to be inadequate to protect Americans from preventable foodborne illness outbreaks.

While the U.S. food supply is among the safest in the world, according to the Centers for Disease Control and Prevention (CDC), foodborne illness remains a costly and common public health problem. Each year, roughly 1 in 6Americans (or 48 million people) get sick, 128,000 are hospitalized, and 3,000 die as a result of foodborne illness. The FDA is responsible for overseeing the safety of 80 percent of the U.S. food supply. However, it is clear from recent events, like the infant formula crisis, there are serious deficiencies that have prevented the agency from acting quickly to address food safety issues.

Following the infant formula crisis of 2022, the Reagan-Udall Foundation conducted an independent investigation of FDA's response. Released in December 2022, the final report describes several issues with the agency's organizational culture, leadership structure, access to resources, and regulatory authorities. We understandFDA has since taken steps to address some of these issues, including proposals to restructure the agency's Center forFood Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and Office of Regulatory Affairs. Given the importance of FSMA to FDA's goal of reducing foodborne illness in the UnitedStates, as well as the increases in funding for food safety,and the recent changes at the agency we request that GAOundertake a review that focuses on the following questions:

1. What have been the key trends in foodborneillness since FSMA was enacted in 2011?
2. To what extent has FDA assessed its owneffectiveness in implementing FSMA to reduce foodborne illness in the United States, and whatmetrics, if any, does FDA use to measure FSMA's success?
3. What challenges, if any, does FDA face as itimplements FSMA, and what barriers, if any, doesFDA face in achieving its goal of further reductions in foodborne illnesses?
4. What impact, if any, have the recommendations inthe Reagan-Udall report and FDA's subsequent proposed changes had on the agency's food safety efforts?
5. What new resources or authorities does FDArequire from Congress to more effectively reduce foodborne illness in the United States?

All of us have an interest in ensuring the food we eat is as safe as possible, and we are committed toworking to ensure all Americans have access to safe andaccessible food supplies. More than a decade after FSMA was enacted, it is important to ensure FDA has the resources and authority necessary to carry out its vital mission of protecting our nation's food supply.

Thank you for your consideration of this request.

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