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Biological control agents can substitute hazardous pesticides and provide environmentally safe and sustainable control of pests, diseases and weeds. Often, exaggerating registration requirements prevent or delay market introduction of micro-organisms, semiochemicals and botanicals. Regulation of Biological Control Agents is the result of the Europe-wide, two-year policy support action REBECA, a forum for representatives of academia, regulation authorities and biocontrol industry to discuss improved regulation rules. It provides a comprehensive review on existing data requirements and registration procedures. Risks and benefits of biocontrol in relation to trade-off effects resulting from unbalanced regulation are discussed.
As a result, proposals for innovative and balanced regulation procedures are presented including recommendations how to accelerate the authorisation process. Considering concerns about possible non-target effects of beneficial insects, mites and nematodes Regulation of Biological Control Agents proposes harmonisation of regulation rules and provides comprehensive material on the data requirements for authorisation, including guidelines for completion of possible application forms for macro-organisms. Regulation of Biological Control Agents is a valuable source on state-of-the-art registration practice and possible policy steps to promote further introduction of biocontrol in agriculture practice.
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
9.1. Introduction
9.2. Mycotoxins of fungal biological control agents
9.3. Standard procedure for toxic metabolite assessment
9.4. Conclusion
9.5. References
10 Risks of biocontrol agents containing compounds of botanical origin or semiochemicals
10.1 Introduction
10.2 Botanicals and semiochemicals: definitions for a concept in evolution
10.3 Risk assessment
10.4 Pheromones
10.5 Botanicals and plant allelochemicals
10.6 Conclusion
10.7 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
