Between November 30 2010 and January 4 2011, the Food Drug and Administration (FDA) Food Safety Modernization Act (FSMA), or HR 2751, was passed through the US governing bodies, representing the first large-scale change in US food safety law since the 1930s. For three years, federal food safety law was discussed in over two dozen congressional hearings (Johnson, 2010a). The text has undergone multiple revisions and collaborative efforts: legislation concerning fresh fruit and vegetable produce alone received over 700 comments from hundreds of stakeholders (Gorny, 2011). Though the US food safety regime is one of the best in the world, there were telling signs of needed change. US consumers now spend 1 trillion USD on food per year (Johnson, 2010b). Increases in food safety concerns like food borne illness have gained global visibility and have lead to negative trade consequences (the recent fatal E. Coli outbreak in Germany exemplifying this quite clearly). Industry and public support for the Act was strong from the onset, yet some policymakers, private sector stakeholders, and small producers remain concerned about implementation, costs, equal opportunity, and market and price effects. This paper firstly gives reasons for the changes in food safety law and regulations in the US. A second section frames how food safety regulations are created—reviewing the challenges associated with science-based evidence, multi-actor expectations, and consumer knowledge. The paper discusses the current US regulations and how they will change in the coming years. Finally, the concerns raised about the implementation and regulatory design are reviewed, concluding with a short note on how these legislative changes may influence the data collected for the EU-NTM project.