The Registration and Regulation of Biopesticides in Taiwan

Abstract

In Taiwan, the biopesticides are divided into three categories including natural products, biochemical agents, and microbial agents. A total of 52 agro-pesticide permits of biopesticide have been registered in Taiwan. Most of biopesticides are classified as microbial agents, and the majority components of microbial agents are Bacillus thuringiensis and Bacillus subtilis which have 24 and 10 agro-pesticide permits, respectively. According to the statistics of agro-pesticide production report, the biopesticide sales volume in Taiwan was 0.401, 0.295, and 0.225 % of total pesticide sales volume in 2009, 2010, and 2011, respectively. The amount of sales volume was far lower compared to the global biopesticide sales volume (6.46 %). Besides, the requirements of food safety from consumers and the booming of organic farming contribute to accelerating the development of biopesticides. In dealing with the need of more biopesticides, the competent authority for agro-pesticide management, Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ), Council of Agriculture (COA), has decreased the requirements of biopesticide registration on the basis of product safety; if the biopesticide is developed by using local microorganisms as active ingredients, the testing data of toxicology required for product registration has been reduced to only three items, including acute oral toxicity/pathogenicity, acute dermal toxicity/pathogenicity (conditional, depends on the formulation of biopesticides), and acute pulmonary toxicity/pathogenicity data. In addition, it does not need to provide the data of wettability, stability test, and preheat treatment for heat tolerance. Furthermore, BAPHIQ continued to revise two key regulations on agro-pesticide registration in 2013, such as “standards for physicochemical property tests and toxicology testing of agro-pesticides” and “standards for agro-pesticide field test,” which is a step further to reduce technical barriers in achieving the goal of promoting biopesticide production. However, biopesticide registrants encounter several problems in Taiwan. First, the complex biological characteristics of microbes are difficult to fit the unique regulation of product specifications. Second, the quality control data is related to the business confidentiality. Third, the requirements of constructing biopesticide factory need to be clarified. Finally, shall biopesticides be listed as least-regulated pesticides? To resolve the abovementioned problems, it is necessary to establish a single-desk unit to provide the preregistration consultation and regulation advice for industry and to set up the standard procedures of research, invention, and registration for enhancing the development of biopesticides.