The Present Regulatory Systems, Their Complexity, and Costs

In the United States, three federal agencies share the regulatory oversight regarding agricultural biotechnology – the United States Department of Agriculture, the Environmental Protection Agency, and the Food & Drug Administration. Despite fifteen years of favorable experience with biotechnology in field trials and commercial release, the agencies have imposed ever stricter regulatory burdens upon biotechnology, rather than lesser regulatory burdens. Moreover, applicants face longer and longer time-lines for gaining a regulatory decision. In several instances, the regulatory agencies simply refuse to act. In addition, court decisions have also imposed additional excessive and costly burdens upon biotechnology. As a consequence, regulatory systems have become a major impediment to further scientific and commercial biotechnology in the United States. The impacts have been particularly severe for public research, especially land-grant universities.

At the international level, under the Cartagena Protocol on Biosafety, similar excessive regulatory burdens and delays are often commonplace. The European regulatory model is especially hostile to agricultural biotechnology.

This presentation will discuss this regulatory phenomenon, domestically and internationally. The presentation will give specific examples of the impacts that these regulatory burdens are having upon agricultural biotechnology and how these regulatory burdens are undermining public policies to address food, fiber, and energy concerns facing the United States and global societies.