Regulation of Biological Control Agents [Paperback]

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.

This book is a valuable source on state-of-the-art registration practice and possible policy steps to promote further introduction of biocontrol in agriculture practice. It gives a comprehensive review on existing data requirements and registration procedures.

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. InitlŠ