Regulations Implementing the Food Safety Modernization Act

Abstract

The FDA has been charged by the 2010 Food Safety Modernization Act (FSMA) with improving food safety in the United States. The four large regulations analyzed in this paper do not appear able to accomplish that mission. Part of the reason for this failure is that Congress has narrowly prescribed some of the reforms that must be in these regulations. In addition to those requirements, however, the FDA is proposing even more expansionist regulations. There are two problems with these regulations and the expansions proposed in the FSMA: either they do not address an actual food safety risk in the areas they cover, or, where there is a significant risk, analysis shows that they will not effectively reduce that risk. Either way, the costs of these rules exceed the benefits, in some cases by a great deal.