StarLink is a genetically engineered corn variety approved in the U.S. for feed (but not food) uses and later discovered in human foods. This article will (a) track the pre-StarLink evolution of U.S. biotechnology regulatory policy and the emergence of the Coordinated Framework for the Regulation of Biotechnology, (b) describe the specific actions taken by APHIS, FDA, and EPA in approving the commercialization of StarLink?, (c) highlight other new developments and subsequent StarLink-related regulatory actions, and (d) glean from the StarLink saga some lessons and insights regarding the U.S. system for biotechnology regulation. This article was published in 7 Drake Journal of Agricultural Law 159 – 211 (2002). Copyright is held by the Drake Journal of Agricultural Law which has given the author permission to use the article for educational purposes. This PDF version (accessed by clicking above) has been formatted so that the page numbers correspond to the page numbers in the printed version in the Drake Journal of Agricultural Law.