title: US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.
abstract: This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.
authors.affiliation: Department of Botany and Plant Sciences, University of California, Riverside, CA 92521-0124, USA. alanmc@ucr.edu
authors.forename: Alan
authors.initials: A
authors.lastname: McHughen
authors.forename: Stuart
authors.initials: S
authors.lastname: Smyth
mesh_terms: D000383:Agriculture / Q000331:legislation & jurisprudence*; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D033161:Government Regulation / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D030821:Plants, Genetically Modified; D014481:United States; D016885:United States Department of Agriculture / Q000266:history; D014484:United States Environmental Protection Agency / Q000266:history; D014486:United States Food and Drug Administration / Q000266:history