Trends affecting the next generation of U.S. agricultural biotechnology: Politics, policy, and plant-made pharmaceuticals

This paper analyzes the structure and history of regulatory policies in the United States, focusing on recent regulatory changes due to the promise and threat posed by plant-made pharmaceuticals (PMPs). PMPs are the latest advance in the genetic engineering of plants and promise to produce medicines inexpensively and abundantly by using a range of different plants as factories to express active medicinal ingredients; however, PMPs may pose a risk to the public's health if they enter the food supply. How the benefits and risks of PMPs are addressed by the respective government's regulation and how this will affect what, if any, products make it to the marketplace and their ultimate success are of great concern to many different parties, ranging from consumers and farmers to health and food production industries. As a result, this paper addresses the history of agricultural biotechnology regulatory policy since 1972, arguing that three distinct periods may be identified: (1) from 1972 to 1986 when the new biotechnology was focused on scientific self-regulation in the laboratory; (2) from 1987 to 2002, as the technology was being developed and widespread release of certain technologies became more common and was not perceived as an environmental threat, regulations became increasingly laxer; and finally, (3) we argue that we are entering a third phase with a series of controversies over regulatory infractions involving genetically engineered (GE) plants and the potential threats posed by PMPs.