FDA and Importers Gain New Responsibility to Police Imported Foods

The U.S. Food and Drug Administration (FDA) and U.S. food importers gained increased authority and responsibility for regulating the supply of imported food under the FDA Food Safety Modernization Act (FSMA), signed into law earlier this year. The Act awarded the FDA for the first time the power to order food recalls. Of course, as FDA Commissioner Margaret Hamburg has emphasized, the FSMA’s primary goal is to prevent unsafe foods from being produced in the first place. With U.S. consumers increasingly relying on food grown or processed overseas, the FSMA charges the FDA with inspecting foreign food processors and distributors, giving the agency the power to form agreements with foreign governments to accomplish this mission. The Act requires the FDA to establish overseas offices to support inspections of foreign food facilities and to reject food imports from any foreign facilities that refuse to undergo U.S. inspections. The FSMA gives the FDA authority to require affirmative safety assurances for specific food types before allowing them into the U.S. The FSMA also increases importers’ responsibility for food safety by requiring them to implement preventive safety plans at their facilities and to provide records of those plans to the FDA. The FDA is then required to establish a tracking system of the information obtained from importers. In conjunction with the Department of Homeland Security, the FDA is also authorized to create a program to expedite review of pre-approved importers and their suppliers. The strategy of leveraging the resources of importers as key actors in an overall system of regulatory governance was propounded last year in the book Import Safety: Regulatory Governance in the Global Economy, edited by Cary Coglianese, Adam Finkel, and David Zaring of the Penn Program on Regulation. The FSMA reflects an example of what Coglianese and Zaring, in the book’s concluding chapter, call “delegated governance,” an approach to consumer protection that relies on “combining targeted public action with private inspections, public and private standard-setting.” Zaring and Coglianese explain that the case for giving more responsibility to private sector importers grows out of the “size of the problem of regulating imports, which dwarfs the public resources available.” By making importers more accountable for their products, the FSMA aims to improve the nation’s overall system of preventative regulation