Format:
Online-Ressource (XII, 393 p. 14 illus., 10 illus. in color, digital)
ISBN:
9789400721562
Series Statement:
SpringerLink
Content:
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.
Note:
Description based upon print version of record
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Regulation of Agricultural Biotechnology: The United States and Canada; Foreword; Preface; References; Contents; Chapter 1: An Introduction to Agricultural Biotechnology Regulation in the U.S.; 1.1 Background; 1.2 Early Regulatory Development for Biotechnology Products; 1.3 Coordinated Federal Framework; 1.3.1 Role of the Animal and Plant Health Inspection Service; 1.3.2 Role of the U.S. Environmental Protection Agency; 1.3.3 Role of the Food and Drug Administration; 1.4 Trends; References; Chapter 2: Regulation of Genetically Modified Crops in USA and Canada: Canadian Overview
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2.1 The Canadian Regulatory Framework2.1.1 Overview of the Regulatory Framework; 2.2 The Regulation of New Crop Varieties; 2.3 The Development of the Initial Framework: 1988-1995; 2.3.1 The Scientific Approach to the Initial Genetically Modified Crop Regulations; 2.3.2 The Process of Developing PNT Regulations in Canada; 2.4 Canada's Present Regulatory Framework; 2.4.1 The Canadian Food Inspection Agency (CFIA); 2.4.2 Health Canada (HC); 2.4.3 Environment Canada (EC); 2.5 Conclusions; References; Chapter 3: Regulation of Genetically Modified Crops in USA and Canada: American Overview
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3.1 Introduction3.2 The Application of Genetic Modification to Plant Agriculture; 3.3 The US Regulatory System; 3.3.1 The Development of the Initial Framework: 1976-1989; 3.3.2 US Regulatory Agencies; 3.3.2.1 The United States Department of Agriculture (USDA); Field Trials with GM Plants; Noti fi cations; Permits; Deregulation and Commercial Release; National Environmental Policy Act 10; Current Status; 3.3.2.2 The Food and Drug Administration (FDA); Food and Drug Administration Procedures; 3.3.2.3 The Environmental Protection Agency (EPA); Environmental Protection Agency Procedures
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3.4 Summary3.5 Conclusions; References; Chapter 4: Regulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA; 4.1 Introduction; 4.1.1 Historical Regulatory Perspective; 4.2 FIFRA Risk Assessment of Genetically Engineered Microbial Pest Control Agents; 4.2.1 Biotechnology Notification Process for Microbial Pest Control Agents; 4.2.2 Experimental Use Permits for Microbial Pest Control Agents; 4.2.3 Section 3 Registration of Microbial Pest Control Agents; 4.3 Risk Assessment Considerations; 4.3.1 FIFRA; 4.3.2 FFDCA; 4.4 Entomopathogenic Nematodes
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4.5 Considerations of Genetic Engineering and Gene Transfer4.5.1 Public Perception of GE Microbials; 4.5.2 Future for GE Microbials in Pest Management; 4.6 TSCA Risk Assessment of Intergeneric Microorganisms; 4.6.1 TSCA Regulation of Microorganisms; 4.6.2 Categories of Premanufacturing Oversight; 4.6.2.1 Microbial Commercial Activity Notice (MCAN); 4.6.2.2 Exemptions from Full Premanufacturing Notification; Research and Development Exemption; Tier I and Tier II Exemptions; Test Marketing Exemption (TME); 4.6.2.3 TSCA Experimental Release Application (TERA)
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Exemptions from a TERA for Eligible Microorganisms
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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..
Additional Edition:
ISBN 9789400721555
Additional Edition:
Buchausg. u.d.T. Regulation of agricultural biotechnology Dordrecht : Springer, 2012 ISBN 9789400721555
Additional Edition:
ISBN 9400721552
Language:
English
DOI:
10.1007/978-94-007-2156-2
URL:
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