The Food Safety Modernization Act (FSMA) which was signed into law in January, 2011 represents a major initiative to improve food safety in the US. The legislation mandates the US Food and Drug Administration with developing a regulatory system to implement the Act. As yet, the full effect of the Act cannot be evaluated because the regulatory requirements are yet to be developed. There is little doubt, however, that those firms, both domestic and foreign, that wish to supply US consumers with food will face a considerable increase in regulatory costs. This paper outlines the major requirements of the FSMA and suggests how the regulatory burden may fall on foreign versus US domestic suppliers. Areas where Canadian firms may be disadvantaged relative to US firms are outlined. Opportunities that may arise from the FSMA for Canadian agri-food firms are discussed, as are the areas where the FSMA may not conform with the international trade commitments of the United States.