Biotechnology & Nanotechnology: Regulation Under Environmental, Health, and Safety Laws analyzes regulation governing biotechnology and nanotechnology industries. Regulation of biotechnology, which generally encompasses the manipulation of living materials by passing genetic information from one organism to another, emerged in the 1970's and is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields. Nanotechnology, which refers to the design and production of molecular-sized devices and products, is a more recent field whose regulation has an impact on the same industries as biotechnology and also affects semiconductors, communications technology, cosmetics, and consumer products. Additional regulation is quite likely because the need for knowledge of the risks involved in industry processes and products is increasing. Both fields are subject to the same regulatory schemes, and this book describes the application of substantive laws, such as the Federal Food, Drug, and Cosmetic Act, the Clean Water Act, and the Clean Air Act, to each segment of the biotechnology nanotechnology industry. Also discussed are international issues and ongoing development of regulations governing these fields.
David Naidu is a partner at Kirkpatrick & Lockhart Preston Gates Ellis LLP, where he advises clients on CERCLA, Clean Water Act, Clean Air Act, TSCA, OSHA, RCRA, land use, as well as other federal and state statutes and environmental, health and safety regulations. He has written several articles on these subjects, including, most recently, "Nanotechnology: An Update on Business Opportunities and Regulatory Challenges," in the Journal of Biolaw and Business.