ABSTRACT
The regulation of biotechnology from research through product marketing and disposal in many countries involves a complex series of laws. This chapter discusses the evolution of the regulatory framework for biotechnology in the United States and provides overview of the principal applicable policies, laws, regulations, and agency procedures. It reviews the history of the regulation of rDNA research in the US and discusses the United States regulatory framework. For decades the scientific community has been busy first seeking to discover the structure of DNA and thereafter trying to understand how DNA is organized and how it functions. Regulation of research, development, and the commercialization of biotechnology is still in a formative stage. To date, Environmental Protection Agencies' regulation of biotechnology has focused on microbes introduced into the environment. The debate about the regulation of biotechnology in the United States continues.
