Regulating Genetically Engineered Microbial Products Under the Toxic Substances Control Act
Editors' Summary: Biotechnology has moved out of the labs and scientific journals and into the chemical plants of large chemical companies and small innovators and the popular press. Those in the federal government responsible for protecting the public from threats to its health and environment are struggling to find a coherent framework for regulating biotechnology. But like some other environmental problems of recent discovery—groundwater pollution, for example—no single statute clearly controls. Statutes as diverse as FIFRA, the Food, Drug, and Cosmetic Act and the OSH Act have been called up. But potentially the most important statutory authority, because it is not limited to a single category of use like the other statutes, is TSCA. The author takes a critical look at EPA's proposal to use TSCA to regulate biotechnology and, with reference to the legislative history and language of the Act as well as relevant case law, concludes that TSCA can be used effectively to regulate several important aspects of biotechnology development.