Page 66

Implementing Biological Control Agents in the ASEAN Region

65 6 Manufacturing process (extraction, formulation, etc.; may become part of identity of product) R 7 Test procedures and criteria for identification R 8 Impurities  Toxic metabolites apart from actives (substances of concern)  Inactive metabolites  Microbial & process impurities (methods of removal) R 9 Shelf life claim R 10 A sample for verification R B. Toxicological evaluation 11 Minimum risk check: plant extract/product (internationally) recognised as:  Minimal risk pesticide  Part of pharmacopoeia  Food grade  History of safe use C R 12 Toxicological testing (method based on degree of characterisation of active compounds)  Standard toxicology for active ingredient(s)  ‘Tox’ of biomarked active fraction (actives unknown)  Toxicological testing of whole extract (biomarkers and actives not known) C 13 Environmental safety testing (ecotoxicology) C C. Bio-Efficacy 14 Field studies  Based on ‘draft efficacy test protocol’ for botanical pesticides (see Appendix III) Remark: Amenable to data waivers if extensive field experience exists R 15 Laboratory studies NR Remarks: • Bio-efficacy of botanicals is naturally lower than that of synthetic pesticides, which requires efficacy categories different to synthetics. Consequently, efficacy testing of botanicals is often not comparable with synthetic pesticides as positive standards.

• Next Page
• Previous Page

• 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
To see the actual publication please follow the link above