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Implementing Biological Control Agents in the ASEAN Region

64 However, this cannot be considered as a "residue". F. Human Health Exposure/Environmental Fate and Effects Data  If any results from tier 1 suggest further risk assessment C Re marks: • Extrapolation to human health can be done from mammalian testing if the microbial pest control agent is in any category of concern. Identification as a true (i.e. excluding results from immuno-compromised individuals) human pathogen means rejection of the active agent. • Up to date, no micro-organisms used for biocontrol worldwide have shown CMR effects (carcinogenicity, mutagenicity, reproductive toxicity). • Results from monitoring programs and health surveys of ‘worker's safety’ at the production site must be used to assess general human health risks. • Usually no need for investigation of degradation and movement within and between compartments, if the risk of spread is tested earlier with host range, infectivity, etc. Technically, tracing micro-organisms in the open can be accomplished using genetic diagnostic methods (e.g. PCR) employing markers specific for the BCA and its target. G. Additional Data Requirements C IIb Botanical Pesticides No. Folder A.I. Formulation Tier 1 Requirements A. Biological and Chemical Characteristics 1 Systematic name (genus and species of plant) R 2 Common name R 3 Source or origin (locality and conditions of growth; may become part of identity of product) R 4 Specification of product (nature, purpose, and usage) R 5 Characterisation of the product (analytical approach optional)  Active ingredient(s)  Biomarker linked or unlinked to activity  Gross constituents C R

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• Summary
• Contents
• Glossary
• Preface
• 1 Introduction
• 1.1 Project history, terminology & stakeholders
• 1.1.1 Biological Control Agents (BCA): categories and terminology
• 1.1.2 Farmers and other stakeholders
• 1.2 Role of BCA in IPM
• 1.3 Sustainability: who will develop BCA products?
• 2 BCA profiles
• 2.1 Microbials
• 2.1.1 Bacteria
• 2.1.2 Fungi
• 2.1.3 Protozoa
• 2.1.4 Insect viruses and entomopathogenic nematodes
• 2.2 Macrobial agents
• 2.3 Semiochemicals
• 2.4 Natural (botanical and other) products
• 2.5 Formulations, quality control, and application techniques
• 2.5.1 Formulations of microbials
• 2.5.2 Quality control and labelling of BCA
• 2.5.3 Application techniques
• 3 Crops: Case studies
• 3.1 Rice
• 3.1.1 Member States’ experience, scientific evidence, market information (ABC database), and results from field trials
• 3.1.2 Conclusions: development of BCA in rice production
• 3.2 Vegetables
• 3.2.1 Member States’ experience, scientific evidence, market information (ABC database), and results from field trials
• 3.2.2 Conclusions: development of BCA in vegetable production
• 3.3 Fruits
• 3.3.1 Member States’ experiences, scientific evidence, market information (ABC database)
• 3.3.2 Conclusions: development of BCA in fruit production
• 4 Regulatory requirements
• 4.1 Towards a regulation for BCA in ASEAN
• 4.2 National frameworks
• 4.3 Harmonisation
• 4.4 The need for simplification
• 4.5 Post-registration issues and quality control
• 4.6 Trade of BCA products within ASEAN
• 5 Strategy for Improvement of Regulation and Use
• 5.1 Needs for the ASEAN Region
• 5.2 Availability
• 5.3 Reliability
• 5.4 User Knowledge
• 5.5 Perceptions of efficacy
• 5.6 The 4th plenary meeting of application and regulation experts: a way forward
• Appendix I Products
• Appendix II Data Requirements for Registration
• Appendix III Efficacy Test Protocols
• References

Implementing Biological Control Agents in the ASEAN Region
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