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Regulation of Biological Control Agents

This book presents a comprehensive compilation of registration requirements necessary for authorisation of biological control agents (viruses, bacteria, fungi, active substances of natural origin and semiochemicals) in OECD countries. It also reviews data requirements for invertebrate agents (insect, mites and nematodes) and provides proposals for harmonisation of the regulation process and guidelines for completion of application forms. Based on results of the EU REBECA Policy Support Action, which gathered experts from academia, regulation authorities and industry, risks and benefits of the specific agents were reviewed and proposals for a more balanced registration process elaborated, including recommendations for acceleration of the authorisation process and discussions on trade-off effects and policy impacts. All these aspects are covered in detail in this book, which points the way forward for enhanced utilisation of biological control agents.
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Table of Contents

General Aspects of Regulation 1 Regulation of biological control agents and the EU Policy Support Action REBECA 1.1 Biological control and regulation of biological control agents 1.2 Regulation of biological control agents in Europe - the REBECA Policy Support Action 1.3 History of biocontrol registration 1.4 The precautionary principle in risk assessment 1.5 Stakeholders 1.6 References 2 Regulation according to EU Directive 91/414: data requirements and procedure compared with regulation practice in other OECD countries 2.1. Introduction 2.2. Methodology and Terminology 2.3. Legal framework and regulatory procedures 2.4. Analysis of formal data requirements 2.5. Practical experience with the regulatory process 2.6. Initiatives taken to facilitate the registration of BCAs in the EU 2.7. Major changes due to the New Regulation 1107/2009 2.8. Overall conclusions 3 An international comparison of invertebrate biological control agent regulation: what can Europe learn? 3.1 Introduction 3.2 Comparative analyses of international regulation 3.3 Conclusions and recommendations 3.4 References 4 Regulation of plant protection in organic farming 4.1 What is organic farming? 4.2 Regulation of organic farming 4.3 Plant protection in organic farming 4.4 Authorization of new pesticides for organic farming 4.5 Organic plant protection in practice: regulation and other determinants 4.6 References 5 Policy Aspects of Regulation 5.1 The Regulatory State 5.2 Dysfunctional aspects of regulation 5.3 Governance 5.4 Solution oriented stakeholder engagement 5.5 Regulatory innovation 5.6 References 6 Cost-benefit, risk and trade-off analysis of regulation 6.1 The risk society and regulation of biological control 6.2 Methods for assessing the cost-benefit relation and economic efficacy of regulation 6.3 Costs of regulation 6.4 Benefits of regulation and cost-benefit ratio 6.5 Trade-off analysis 6.6 Agriculture policy and biological control 6.7 References Risks and Risk Assessment 7 Risks of microbial biocontrol agents and regulation: are they in balance? 7.1 Introduction 7.2 Regulation as it exists today 7.3 Requirements of Annex II B of Directive 91/414 7.4 Conclusion 7.5 References 8 Ecology and human pathogenicity of plant-associated bacteria 8.1 Molecular ecology of plant-associated bacteria 8.2 Plants as reservoir for opportunistic human pathogenic bacteria? 8.3 Caenorhabditis elegans: a model to assess pathogenicity factors 8.4 Influence of antagonistic bacteria on indigenous microbial communities 8.5 Conclusions 8.6 References 9 Metabolite toxicology of fungal biocontrol agents 1. Introduction 2. Mycotoxins of fungal biological control agents 3. Standard procedure for toxic metabolite assessment 4. Conclusion 5. References 10 Risks of biocontrol agents containing compounds of botanical origin or semiochemicals 10.1 Introduction 10.1 Botanicals and semiochemicals: definitions for a concept in evolution 10.2 Risk assessment 10.3 Pheromones 10.4 Botanicals and plant allelochemicals 10.5 Conclusion 10.6 References 11 Risks of invertebrate biological control agents - Harmonia axyridis as a case study 11.1 Benefits and risks of biological control 11.2 Harmonia axyridis as a model high risk biological control agent 11.3 Concluding remarks 11.4 References Proposals for Balanced Regulation Procedures 12 Facilitations in the regulation of plant protection products containing baculoviruses 12.1 Introduction 12.2 The OECD consensus document 12.3 Genetic composition of baculovirus isolates 12.4 Potential risks from plant protection products containing baculoviruses 12.5 Current regulatory situation in the EU 12.6 Proposal for facilitated regulation of baculoviruses as active ingredients in plant protection products 12.7 Data Protection 12.8 Remark on genetically modified baculoviruses 12.9 Regulatory situation 12.10 Proposal on threshold levels for microbial contaminations in baculovirus products 13 Proposals for bacterial and fungal biocontrol agents 13.1 Introduction 13.2 Pre-Submission Meeting 13.3 Identification of low risk products 13.4 Risk assessment methodology 13.5 Proposed waivers 13.6 References 14 Proposals for regulation of botanicals 14.1 Introduction 14.2 Widely used botanicals 14.3 Environmental impact and human health risks of botanicals 14.4 Overview of regulation and regulatory efforts for botanicals 14.5 Bottlenecks under the current system 14.6 Proposals of the REBECA project 14.7 Evaluation of the REBECA proposals 14.8 Acknowledgements 14.9 References 15 Proposals for regulation of semiochemicals 15.1 Introduction 15.2 Semiochemicals in plant protection 15.3 Environmental impact and human health risks of semiochemicals 15.4 Fourth stage review of semiochemicals in the EU 15.5 Bottlenecks under the current system 15.6 Proposals of the REBECA project 15.7 Evaluation of the REBECA proposals 15.8 Acknowledgements 15.9 References 16 Regulation of invertebrate biological control agents in Europe: recommendations for a harmonised approach 16.1 Introduction 16.2 Principles of a balanced regulatory system for IBCAs 16.3 Standardised Licence (Permit) Application Form and Guidance Document 16.4 Role of ERA in a regulatory system 16.5 Validation of ERA and Licence (Permit) Application process 16.6 Implementation of a pan-European Regulatory System 16.7 Wider issues concerning implementation 16.8 Conclusions 16.9 References 17 Proposals on how to accelerate registration of biological control agents 17.1. Abstract 17.2. Introduction 17.3. Fees and financial support 17.4. Improve communication between regulators and applicants 17.5. Improve communication among regulators of biological control agents 17.6. QPS approach in risk assessment 17.7. Define low risk biological control agents/substances for fast track authorization 17.8. Guidance documents based on experience from the 4th stage evaluation 17.9. Timelines 17.10. Centralized registration authority 17.11. Optimal legislative framework 17.12. Efficacy evaluation 17.13. Perspectives 17.14. References Index

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