• Microbials: risk assessment of micro-organisms is not appropriate and remains inconclusive if one applies tools of ‘classical’ toxicological analysis only. Instead, the major determinants for examining the risk that these organisms might pose are infectivity, host specificity, and pathogenicity. Having defined host specificity properly, this would answer another host of questions that commonly has its bearing during the ‘ecotoxicological’ phase of assessment. • Botanicals/plant extracts: to date, regulators treat plant extracts as compounds of a single active ingredient. However, common water-based or alcoholic extracts can contain dozens of ingredients, each of which may or may not exhibit certain activities and toxicological properties. Inexperience of regulators with this circumstance is a major regulatory hurdle for botanicals. The characterisation of such ‘soups’ is challenging, but possible, and approaches for this have been devised by OECD and the EU, which are now annotated in ASEAN’s minimum data requirements. Additionally, it is recommended that consideration is given to the history of safe use for these two groups of BCA; lists of ‘low risk’ substances and microbials have been published internationally. With regard to the import and release of macro-organisms for biocontrol, the AMS agreed to apply the procedures proposed by FAO in 2005 (52). But how should regulators deal with native macro-organisms? Would they need to be regulated at all? Almost all Member States agreed that if they were used as commercial products, regulation would be somehow required, irrespective of their origin. In this regard, Indonesia and the Philippines, both countries consisting of a patchwork of islands, remarked that due to different ecological zones, it would be recommendable to regulate the movement of native organisms, too. There exist bio-safety committees that deal with such questions already. However, given the fact that there is little interest of the private sector in this BCA group in ASEAN while the still rare applications are mostly dealt with by the government sector, there is probably no urgent need for a new regulation. Regulatory aspects for semiochemicals were presented in Chapter 2. Similarly, regulatory inexperience with how to deal with botanicals effectively inhibits their wider distribution. This is revealed by the ABC database which just lists one registered product (as of 2012), although its use is probably significant, particularly in the plantation sector of Southeast Asia. 44
Implementing Biological Control Agents in the ASEAN Region
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