ELI Publishes Comprehensive Guide to Understanding Federal Biotechnology Regulation

December 2001

Few topics are as controversial as the use of genetically modified organisms (GMOs). Plants that express their own insect repellants, fish that grow faster or bigger, and foods modified to provide greater nutrient value are just some examples of how GMOs can be placed into everyday life. The Environmental Law Institute® has just published the first book that guides readers through the maze of federal laws and regulations, describing how the various requirements apply to different intended uses.

The Biotechnology Deskbook provides extensive analysis of the Coordinated Framework for the Regulation of Biotechnology and the Policy on Planned Introductions of Biotechnology Products. The book discusses the substantial body of regulation and guidance for particular types of organisms, as well as recent case studies that provide examples of the application of these requirements. The book also examines the role of National Environmental Policy Act (NEPA) in assuring full consideration of the environmental effects of proposals for federal actions having significant environmental impacts, including releases.

Current regulatory programs of the U.S. Department of Agriculture, the Environmental Protection Agency, the Department of the Interior, and the Food and Drug Administration are described, as are other applicable statutes. Liability and enforcement issues are also examined in this up-to-date book. It is the only available resource that contains both a comprehensive analysis and the texts of valuable agency memoranda and case studies.

The book is co-authored by William L. Anderson, Nancy S. Bryson, Robert C. Davis, Jr., Philip Katz, Richard J. Mannix, Steven P. Quarles, Richard E. Schwartz from the Washington, DC law offices of Crowell and Moring LLP, and William M. Cohen from the DC law offices of Perkins Coie LLP, and Adjunct Professor at American University Washington College of Law.

The Biotechnology Group of Crowell & Moring represents businesses and individuals at every level and phase of the world’s biotechnology revolution. Crowell & Moring is a full service law firm with its principal office in Washington, DC and offices in Irvine, California, London, and Brussels. Perkins Coie is a leading international law firm with 14 offices in North America and Asia. The firm’s expertise ranges from traditional enterprises such as manufacturing and real estate to emerging fields such as life sciences and technology.

Copies of the Biotechnology Deskbook can be ordered from the Island Press Web site. For more information about ELI visit our Web site at http://www.eli.org.