Regulation of agricultural biotechnology : the United States and Canada

Agricultural biotechnology takes many forms and applications, with the number and diversity of products ever increasing. With this rapid development, regulatory authorities have sought to keep pace through regulatory adjustments and advances to ensure the safe and beneficial use of this critical technology. The regulatory systems for the U.S. and Canada are not static and must evolve in order to maintain relevance, efficiency and applicability to the challenges encountered. The diverse authors, drawn from the biotechnology industry, academia, government research and regulatory agencies, offer their perspectives of the historical and current system and suggest where it can be improved in the future. Based upon vast experience interacting with the regulatory system, the editors and authors offer demystifying views of the US and Canadian regulatory structures and how they came to be. We know of no other effort to present the biotechnology regulatory systems of the US and Canada in an open forum which will benefit those in the regulated community as well as those charged with oversight of the products of biotechnology, and ultimately the consumer! Agricultural Biotechnology Takes Many Forms And Applications, With The Number And Diversity Of Products Ever Increasing. With This Rapid Development, Regulatory Authorities Have Sought To Keep Pace Through Regulatory Adjustments And Advances To Ensure The Safe And Beneficial Use Of This Critical Technology. The Regulatory Systems For The U.s. And Canada Are Not Static And Must Evolve In Order To Maintain Relevance, Efficiency And Applicability To The Challenges Encountered. The Diverse Authors, Drawn From The Biotechnology Industry, Academia, Government Research And Regulatory Agencies, Offer. An Introduction To Agricultural Biotechnology Regulation In The U.s. / Chris A. Wozniak, Annabel Fellman Waggoner, And Sheryl Reilly -- Regulation Of Genetically Modified Crops In Usa And Canada : Canadian Overview / Stuart J. Smyth And Alan Mchughen -- Regulation Of Genetically Modified Crops In Usa And Canada : American Overview / Alan Mchughen And Stuart J. Smyth -- Regulation Of Genetically Engineered Microorganisms Under Fifra, Ffdca And Tsca / Chris A. Wozniak, Gwendolyn Mcclung, Joel Gagliardi, Mark Segal, And Keith Matthews -- The Status, Promise And Potential Perils Of Commercially Available Genetically Modified Microorganisms In Agriculture And The Environment / Anne K. Vidaver, Sue Tolin, And Angela Post -- Regulatory Experience In Symbiotic Control Of Pierce's Disease / Thomas A. Miller -- Over A Decade Of Crop Transgenes Out-of-place / Norman C. Ellstrand --^ The Regulation Of Organisms Used In Agriculture Under The Canadian Environmental Protection Act, 1999 / Heather Darch And Arash Shahsavarani -- Regulating The Environmental Release Of Plants With Novel Traits In Canada / Krista Thomas And Stephen Yarrow -- Epa Regulatory Requirements For Plant-incorporated Protectants / John L. Kough And Rebecca Edelstein -- United States Environmental Protection Agency Insect Resistance Management Programs For Plant-incorporated Protectants And Use Of Simulation Modeling / Sharlene R. Matten, Robert J. Frederick, And Alan H. Reynolds -- Development And Regulation Of The Plum Pox Virus Resistant Transgenic Plum Honeysweet / Ralph Scorza, Ann Callahan, Michel Ravelomandro, And Michael Braverman -- Genetically Engineered Insects : Regulatory Progress And Challenges / Luke S. Alphey And Camilla J. Beech -- Regulation Of Genetically Engineered Animals / Elizabeth A. Maga And James D. Murray --^ Regulatory Science, Research Science And Innovation In Agricultural Biotechnology / Alan Raybould, Ryan Kurtz, And Lawrence Zeph -- The Globalization Of Agricultural Biotechnology : Implications For Regulatory Compliance, Stewardship And Stakeholder Engagement / Jeffrey D. Rowe, Firoz Amijee, Steven D. Brody, Greg G. Wandrey And Courtney Chabot Dreyer -- Facilitating Market Access For Ge Crops Developed Through Public Sector Research / Nina V. Fedoroff And Roger Beachy. Chris A. Wozniak, Alan Mchughen, Editors. Includes Bibliographical References And Index. Front Matter....Pages i-xii An Introduction to Agricultural Biotechnology Regulation in the U.S.....Pages 1-14 Regulation of Genetically Modified Crops in USA and Canada: Canadian Overview....Pages 15-34 Regulation of Genetically Modified Crops in USA and Canada: American Overview....Pages 35-56 Regulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA....Pages 57-94 The Status, Promise and Potential Perils of Commercially Available Genetically Modified Microorganisms in Agriculture and the Environment....Pages 95-102 Regulatory Experiences in Symbiotic Control of Pierce’s Disease....Pages 103-122 Over a Decade of Crop Transgenes Out-of-Place....Pages 123-135 The Regulation of Organisms Used in Agriculture Under the Canadian Environmental Protection Act, 1999 ....Pages 137-145 Regulating the Environmental Release of Plants with Novel Traits in Canada....Pages 147-162 EPA Regulatory Requirements for Plant-Incorporated Protectants....Pages 163-174 United States Environmental Protection Agency Insect Resistance Management Programs for Plant-Incorporated Protectants and Use of Simulation Modeling....Pages 175-267 Development and Regulation of the Plum Pox Virus Resistant Transgenic Plum ‘HoneySweet’....Pages 269-280 Genetically Engineered Insects – Regulatory Progress and Challenges....Pages 281-299 Regulation of Genetically Engineered Animals....Pages 301-315 Regulatory Science, Research Science and Innovation in Agricultural Biotechnology....Pages 317-333 The Globalization of Agricultural Biotechnology: Implications for Regulatory Compliance, Stewardship and Stakeholder Engagement....Pages 335-375 Facilitating Market Access for GE Crops Developed Through Public Sector Research....Pages 377-390 Back Matter....Pages 391-393