63 12 Infectivity, pathogenicity and host specificity (living micro-organism) Including relevance for human health and other non-target organisms (‘ecotox’) R Tier 2: if reasons for concern (e.g. contaminants, toxic properties of formulating compound, etc.) 13 Toxicity (secondary metabolites of micro-organisms) Remark: Metabolites (biochemical compounds) of micro-organisms could be also treated as ‘Natural Products’, which would classify them as chemical compounds that undergo classical toxicological analysis. R Tier 2: as above C. Bio-Efficacy 14 Field studies Based on ‘draft efficacy test protocol’ for microbials (see Appendix III). Remark: Amenable to data waivers if extensive field experience exists R 15 Laboratory studies Including confirmation of claims of target specific action and potency (R) D. Processing, Packaging, and Labelling 16 Process of formulation R 17 Usage and storage information R 18 Labels and leaflets R Tier 2 Requirements E. Residue Data Only relevant if residues of the active agent of any kind are likely and to be expected on food or feed items. Substances used for formulation must not produce residues on feed or food items. This must be documented by relevant references. C Re marks: • Based on the available experience and evidence to date, it is assumed that by their nature microbial pest control agents do not produce chemical residues in food. • Microbial metabolites, although effective, are usually readily biodegradable. • The persistence of micro-organisms intentionally introduced into agro-ecosystems (though they will normally not persist on or in the food items) is a matter of host range. In many cases, the micro-organisms introduced as biocontrol agents may already exist in the environment, and application may lead to transient changes in the composition of the (soil) microflora.
Implementing Biological Control Agents in the ASEAN Region
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