Data Decision Tree for identifying potential risks for microorganisms when used in plant protection

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ABSTRACT Biocontrol, including microorganisms, can offer a balanced solution for problems caused by the widespread use of conventional chemical pesticides. Unacceptable harmful side effects of many conventional pesticides are becoming increasingly clear, in terms of the potential for adverse human health effects, the overexploitation of land and the environmental pollution they cause. Concurrently, there is awareness that modern agriculture needs to grow crops more sustainably. Substances used in plant protection including microorganisms, are regulated mainly following the same system as for conventional chemical pesticides to evaluate potential effects on human and environmental safety. Data requirements are adapted in many regulatory systems, but in most cases, they are still derived from data requirements for chemicals and do not sufficiently consider biology and ecology of microorganisms. This approach often poses an unnecessarily high and inappropriate regulatory burden because many data requirements and evaluation criteria are not relevant or appropriate. In this paper, a tiered approach was used to indicate potential risk areas and a progressive ‘Data Decision Tree’ and risk-based flowchart was developed. Considering relevant risk factors for microorganisms, a branched Data Decision Tree has been developed that considers: Identity and Biological Properties, Effects on human health, Residues, Effects on non-target organisms, Environmental fate and behaviour. Such a scientific risk-based decision tree approach can streamline the development of data for the dossier and the evaluation. This will accelerate the placing on the market of plant protection products containing microorganisms, which is so important for the transition to more sustainable and more resilient cropping systems.