Biotechnology Deskbook

Biotechnology Deskbook
William L. Anderson, Nancy S. Bryson, Robert C. Davis Jr., Philip Katz, Richard J. Mannix, Steven P. Quarles, and Richard E. Schwartz, Crowell & Moring LLP and William M. Cohen, American University Washington College of Law and Perkins Coie LLP
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Few topics are as controversial as the use of genetically modified organisms in agriculture, medicine, forestry, environmental remediation, and other industrial applications. Genetically engineered enzymes, biopesticides, plants that express their own insect repellants or are engineered to survive herbicides, trees and bacteria designed for bioremediation, transgenic fish that grow faster or quicker, plants and animals capable of producing pharmaceuticals, and foods modified to provide greater nutrient value are only some of the examples. The Biotechnology Deskbook is the only text that guides you through the maze of federal laws and regulations, describing how the various requirements apply to different intended uses.

The Deskbook provides extensive analysis of the Coordinated Framework for the Regulation of Biotechnology and the Policy on Planned Introductions of Biotechnology Products. The substantial body of regulation and guidance for particular types of organisms is discussed, as are recent case studies that provide examples of the application of these requirements. The role of NEPA in assuring full consideration of the environmental effects of proposals for federal actions having significant environmental impacts, including releases, is examined. Current regulatory programs of the U.S. Department of Agriculture, the Environmental Protection Agency, the Department of 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 source that contains both a comprehensive analysis and the texts of valuable agency memoranda and case studies.

This book is an essential tool to understanding the increasingly complex federal review process and the applicable laws and regulations.