Regulation of Agricultural Biotechnology: The United States and Canada

Written in a practical, didactic format designed to deliver point-of-care information to practitioners of cardiology as well as assist non-cardiologists with the efficient management of cardiac disease, this highly illustrated manual is an essential reference.

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!

Biotechnology regulatory systems as experienced by experts from industry, academia and government U.S. and Canadian coverage of microbial, animal and plant regulation Includes insight into avoiding regulatory pitfalls

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Chris Wozniak brings 24 years of experience working with USDA and EPA while Alan McHughen brings over 26 years of working with transgenic organisms as an academic scientist in Canada and USA. Together they compiled a series of chapters from experts from industry, academia and government to explain how the regulations arose, what they are today and how they need to change to keep up with the rapidly evolving technology to assure product safety while not unduly impeding the potential benefits of this powerful technology.

What was the impetus for regulating biotechnology while other methods of genetic modification remain exempted from premarket safety assessments? How were the regulations made? How are they enforced? How do the diverse political agendas meld with the scientific foundation in assessing safety? How does the perspective of the technology developer differ from that of the biosafety regulator? In addressing these questions and others, this book offers authoritative and comprehensive yet accessible and illuminating insights into the agricultural biotech regulatory systems in both countries.

Contenu

Introduction.- Foreword.- 1. Introduction to Biotechnology Regulation: A U.S. History.- 2. Regulation of genetically modified crops in USA and Canada: Canadian overview.- 3. Regulation of genetically modified crops in USA and Canada: American overview.- 4. Regulation of Genetically Engineered Microorganisms under PPA, FIFRA and TSCA.- 5. The promise and potential perils of genetically modified microorganisms in agriculture and the environment.- 6. Regulatory experiences in symbiotic control of Pierce's disease.- 7. Over a Decade of Crop Transgenes Out-of-place.- 8. The Regulation of Organisms used in Agriculture under the Canadian Environmental Protection Act, 1999.- 9. Regulating the Environmental Release of Plants with Novel Traits in Canada.- 10. Regulatory Requirements for Plant-Incorporated Protectants.- 11. United States Environmental Protection Agency Insect Resistance Management Programs for Plant-Incorporated Protectants and Use of Simulation Modeling.- 12. Development and deregulation of the Plum Pox Virus resistant transgenic plum 'HoneySweet'.13. Genetically Engineered Insects - Regulatory Progress and Challenges.- 14. Regulation of Genetically Engineered Animals.- 15. Regulatory science, research science and safety assessment in agricultural biotechnology.- 16. The Globalization of Agricultural Biotechnology: Implications for Regulatory Compliance, Stewardship and Stakeholder Engagement.- 17 - Facilitating market access for GE crops developed through public sector research.