Key words of the passage: biopesticide; Japan; agriculture; registration

Biopesticides are widely used in Japan since the 1950s, with insecticides based on Bacillus thuringiensis (Bt) being introduced in the 1980s. Biopesticides are basically regulated under the Agricultural Chemical Regulation Law. However, from 1990 onwards, discussions on safety assessment of biopesticides ensued as a result of the development of novel products such as microbial pesticides. In 1997, the Ministry of Agriculture, Forestry and Fisheries (MAFF) established a guidance for biopesticide registration listing data requirements and numbers of studies. The guidance defines viruses, bacteria, fungi, protista and nematodes (with symbiotic bacteria producing active ingredients) as biopesticides. Natural enemies such as parasitoid wasps and predaceous insects as well as active substances derived from microbes have been excluded from the scope of the guideline.

While for the registration of chemical pesticides, a full data package as set out under the Agricultural Chemical Regulation Law is required, for the safety assessment of biopesticides a tiered approach is accepted, since most biopesticides are widely occurring in the natural environment and considered not to be harmful to humans and animals. In particular, the tiered approach is applied for the toxicological safety assessment of biopesticides under the guidance, i.e. 1. single dose studies, 2. repeated dose studies and 3. reproductive studies. If evidence indicates potential hazards, higher tier studies are required. In 2003, the Food Sanitation Law was amended to implement a positive list system setting maximum residue limits (MRLs) for all pesticides. Biopesticides are not subject to the positive list. This is an important incentive for biopesticides which have gained attention as key technology to achieve lower agrochemical inputs.

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