Regulation of Agricultural Biotechnology: The United States and Canada

1. Front Matter

   Pages i-xii

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2. An Introduction to Agricultural Biotechnology Regulation in the U.S.

   • Chris A. Wozniak, Annabel Fellman Waggoner, Sheryl Reilly

   Pages 1-14

3. Regulation of Genetically Modified Crops in USA and Canada: Canadian Overview

   • Stuart J. Smyth, Alan McHughen

   Pages 15-34

4. Regulation of Genetically Modified Crops in USA and Canada: American Overview

   • Alan McHughen, Stuart J. Smyth

   Pages 35-56

5. Regulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA

   • Chris A. Wozniak, Gwendolyn McClung, Joel Gagliardi, Mark Segal, Keith Matthews

   Pages 57-94

6. The Status, Promise and Potential Perils of Commercially Available Genetically Modified Microorganisms in Agriculture and the Environment

   • Anne K. Vidaver, Sue Tolin, Angela Post

   Pages 95-102

7. Regulatory Experiences in Symbiotic Control of Pierce’s Disease

   • Thomas A. Miller

   Pages 103-122

8. Over a Decade of Crop Transgenes Out-of-Place

   • Norman C. Ellstrand

   Pages 123-135

9. The Regulation of Organisms Used in Agriculture Under the Canadian Environmental Protection Act, 1999

   • Heather Darch, Arash Shahsavarani

   Pages 137-145

10. Regulating the Environmental Release of Plants with Novel Traits in Canada

    • Krista Thomas, Stephen Yarrow

    Pages 147-162

11. EPA Regulatory Requirements for Plant-Incorporated Protectants

    • John L. Kough, Rebecca Edelstein

    Pages 163-174

12. United States Environmental Protection Agency Insect Resistance Management Programs for Plant-Incorporated Protectants and Use of Simulation Modeling

    • Sharlene R. Matten, Robert J. Frederick, Alan H. Reynolds

    Pages 175-267

13. Development and Regulation of the Plum Pox Virus Resistant Transgenic Plum ‘HoneySweet’

    • Ralph Scorza, Ann Callahan, Michel Ravelonandro, Michael Braverman

    Pages 269-280

14. Genetically Engineered Insects – Regulatory Progress and Challenges

    • Luke S. Alphey, Camilla J. Beech

    Pages 281-299

15. Regulation of Genetically Engineered Animals

    • Elizabeth A. Maga, James D. Murray

    Pages 301-315

16. Regulatory Science, Research Science and Innovation in Agricultural Biotechnology

    • Alan Raybould, Ryan Kurtz, Lawrence Zeph

    Pages 317-333

17. The Globalization of Agricultural Biotechnology: Implications for Regulatory Compliance, Stewardship and Stakeholder Engagement

    • Jeffrey D. Rowe, Firoz Amijee, Steven D. Brody, Greg G. Wandrey, Courtney Chabot Dreyer

    Pages 335-375

18. Facilitating Market Access for GE Crops Developed Through Public Sector Research

    • Nina V. Fedoroff, Roger Beachy

    Pages 377-390

19. Back Matter

    Pages 391-393

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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!

• Agriculture
• Biotechnology
• Genetic Engineering
• Regulation
• Risk Assessment

From the reviews:

“This book describes the history and scope of North American agricultural biotechnology concerns, laws, and policies. Each of the 17 chapters is written by an authority on the topic and contains highly relevant primary source references. … the book explores global regulatory perspectives on biotechnology products and the influence of public sector research on agricultural biotechnology. The text is well written, and the information provided is free from bias. Summing Up: Recommended. All academic and professional public policy, science law, and bioethics library collections.” (B. R. Shmaefsky, Choice, Vol. 50 (9), May, 2013)

• Office of Pesticide Programs, Biopesticides & Pollution, US Environmental Protection Agency, WASHINGTON, USA

  Chris A. Wozniak

• Dept. of Botany & Plant Sciences, University of California, Riverside, USA

  Alan McHughen

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