Appendix II Data Requirements for Registration

Implementing Biological Control Agents in the ASEAN Region

The two sets of data requirements below, for microbials and botanical pesticides (botanicals), propose information requirements for a formulated product and a regular registration (as opposed to provisional or supplementary registrations). In the case of micro-organisms, it was seen advantageous to distinguish between AI and the formulation as a whole at certain information points, so that in these cases requirements are extended to the AI. Both sets of data requirements make use of a template ‘data requirements for harmonized registration of biopesticides’ which was published by FAO in 2012 (Guidance for Pesticide Regulatory Management in Southeast Asia, FAO Regional Office for Asia and The Pacific, Bangkok). The ASEAN regulatory experts agreed that the aspect of harmonisation could be reflected in a ‘minimum’ data requirement set (folders A-D) or tier 1 information package, while additional information requirements (folders E-G) would be treated under tier 2. 62 Appendix II Data Requirements for Registration Abbreviations: R = Required, NR = Not required, C = Conditional IIa Microbials No. Folder A.I. Formulation Tier 1 Requirements A. B iological and Chemical Characteristics 1 Systematic name (genus and species) R 2 Strain/or isolate name of active agent R 3 Common name (if available) R 4 Source or origin, host range, and mode of action of active agent  Mode of action: e.g. non-toxic mechanisms, infection of target, competitive or antagonistic behaviour, etc. R 5 Specification of product (Set of requirements to be satisfied by product) R 6 Composition of the product R 7 Manufacturing process R R 8 Test procedures and criteria for identification  Including method(s) of analysis/biological assay R R 9 Impurities & Contaminants R R Tier 2: further tests if data/results of tier 1 warrant this 10 Shelf life claim R 11 A sample for verification R B. Infectivity & Pathogenicity or Toxicity to Non-Target Organisms

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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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