Trends affecting the next generation of U.S. agricultural biotechnology: Politics, policy, and plant-made pharmaceuticals Patrick A. Stewart a, * , Andrew J. Knight b a Department of Political Science, Masters of Public Administration Program, P.O. Box 1750, Arkansas State University, State University, AR 72467, USA b Department of Criminology, Sociology and Geography, Arkansas State University, State University, AR 72467, USA Received 7 December 2003; received in revised form 3 March 2004; accepted 4 March 2004 Abstract 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. D 2004 Elsevier Inc. All rights reserved. Keywords: Genetic engineering; Agricultural biotechnology; Regulation; Field releases; Plant made pharmaceuticals, PMPs; Plant-made industrial products, PMIPs 0040-1625/$ - see front matter D 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.techfore.2004.03.001 * Corresponding author. E-mail address: pstewart@astate.edu (P.A. Stewart). Technological Forecasting & Social Change 72 (2005) 521–534