Regulation of rbST in the US

Abstract

In the United States (US) and European Union (EU) the regulatory and commercialization process for recombinant bovine somatotropin (rbST) had widely differing outcomes. Although the regulatory process in both locations was completed in 1993 the commercialization of rbST in the US has been highly successful while completely failing in the EU. This paper examines these events from the US perspective and concludes that reasons for the difference in commercial success lie in the cultural, regulatory, and political background differences between the two world locations.