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(170) Regulatory aspects of biopesticides: dead end or challenge? Mensink, Hans1, Scheepmaker, Jacqueline1, Appelman, Jelka 2, van Gelder, Janine2, 1 2 ABSTRACT- Dead End? The need for environmentally safe pesticides is increasing. Biopesticides merit particular attention in this respect, as they may be safer than chemical pesticides. However, registration — and consequently introduction — of biopesticides is not keeping pace with the growing demands. One problem is that a transparent framework with tools for linking data requirements to data evaluation and risk assessment is not yet available. This may hamper new developments in pest management, like working with genetically modified micro-organisms. Companies confirm these "blind spots" in biopesticide registration. Small-scale firms are especially hard-pressed for meeting the demanding registration requirements. They wonder whether the registration "burden" is fair in relation to the natural occurrence of biopesticides. The starting point of the discussion is clearly that "although most biopesticides are much less hazardous to the environment, the fact that they are natural, does not make them automatically safe" [1]. Solutions Current ideas on and efforts in facilitating biopesticide registration: ⋅ Using a common core set of data requirements for microbial pesticides and pheromones [2, 3]. More guidance on tests will make the evaluation process and subsequent risk assessment more transparent. A framework in which data requirements, data evaluation and risk assessment are sketched in more detail is given in [4] and [5]. ⋅ The possible use of data on biopesticide efficacy for evaluating risks of non-target species. This is likely in view of their generally smaller range of bioeffectiveness. ⋅ A possible additional element, like the monitoring of adverse field effects after their introduction. Challenge Clearly, registration policies for biopesticides may differ from those for chemical pesticides. However, the system should always allow the "bad guys or girls" to be identified. The challenge will be to develop a system with a balanced, reasonable set of data requirements that will provide sufficient data for a sound scientific risk assessment. Regulatory agencies should take the lead in developing such systems, for example, in the form of decision trees. [1] Pest Man Sci 8:651-676 (2000). [2] Report of OECD Workshop on microbial pesticides, 19-20 Aug 1998. [3] Report of OECD Workshop on pheromones, 27-29 Sept 1999. [4] RIVM Report no. 679102036 (1997). [5] RIVM Report no. 679102043 (1998). Key words: biopesticides, regulation, risk assessment, data evaluation |
