ABSTRACT

In theory, if not in practice, the US approach to the regulation of environmental risks of genetically modified organisms (GMOs) is straightforward. According to a set of policy principles developed in the mid-1980s that continue to guide US regulatory policy today, products developed through biotechnology are subject to the same regulatory scrutiny as comparable products produced through conventional means. In other words, regulation is based on the risk characteristics of the product, not the process by which the product was made. Consequently, the degree to which a product is subject to regulatory scrutiny for environmental risks depends on the nature and the intended use of the product itself. While this policy principle continues to be cited by US policy makers, however, in actual practice the distinction is not as clearly applied as is generally presumed.