生物農藥管理現況與展望

Current Status and Management of Biopesticides and its Prospects in Taiwan

許華芳(Hua-Fang Hsu) ； 王堂凱(Tang-Kai Wang) ； 張瑞璋(Ruey-Jang Chang)

《臺中區農業改良場特刊》 121號 (2014/03) Pp. 1-12

摘要

依據我國農藥管理法規定，生物農藥區分為天然素材，生化製劑及微生物製劑3類，其中以微生物製劑為市場主流，而微生物製劑中又以蘇力菌及枯草桿菌為大宗，分別具有24張及10張農藥許可證，臺灣現有的生物農藥許可證總計52張。2009年至2011年，臺灣生物農藥產值佔農藥產值分別為0.401、0.295及0.225%，與全球生物農藥產值比6.46%仍有一段差距，顯示臺灣生物農藥具有很大的發展空間。消費者食品安全需求及有機農業發展等因素進一步催化生物農藥發展，動植物防疫檢疫局為推動生物農藥的發展，在確保產品安全性之前提下，已簡化生物農藥的登記程序，以本土性微生物研發的生物農藥為例，僅須提供口服急毒性／致病性、皮膚急毒性及肺急毒性／致病性等3種毒理資料，且免檢驗水濕性、安定試驗及耐熱前處理等項目。另更於2013年修訂「農藥田間試驗準則」及「農藥理化性及毒理試驗準則」等2項法規，進一步降低農藥登記之門檻。然而在生物農藥登記仍遭遇不少問題，如產品規格因微生物本身特性複雜無法一體適用、微生物製劑成品的品管資料涉及商業機密、生物農藥工廠的設置及是否為不列管農藥等尚待解決。政府將設立農藥登記單一窗口，供登記廠商預審及諮詢，並且建立生物農藥研發及登記之標準程序，以促進生物農藥產業之發展。

關鍵字

生物農藥 ； 農藥管理法 ； 微生物製劑 ； 農藥登記

並列摘要

Biopesticides are divided into three categories including natural products, biochemical agents and microorganism agents. Most of biopesticides are classified as microorganism agents, and the majority components of microorganism agents are Bacillus thuringiensis and Bacillus sp. which has 24 and 10 agro-chemical permits, respectively. A total of 52 agro-chemical permits of biopesticide have been registered in Taiwan. According to the statistics of agro-chemical production report, the biopesticide productions were only 0.401, 0.295 and 0.225% of total pesticide productions from 2009 to 2011, respectively. The amount of production was far lower compared to the global biopesticide production, which was 6.46%. Besides, the demand of food safety from consumers and the booming of organic farming contribute to accelerating the biopesticide development. In coping with the need of more biopesticides, the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) 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 3 items, including acute oral toxicity/pathogenicity, acute dermal toxicity/pathogenicity and acute pulmonary toxicity/pathogenicity data. In addition, it does not need to provide the data of wettability, stability test and pre-heat treatment for heat tolerance. Furthermore, BAPHIQ continued to revise two key regulations on agro-chemical registration in 2013, such as ”Regulations for the Physicochemical and Toxicological Test of Agro-pesticide” and ”Standard of Agro-pesticide Field Test”, 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 microbe's complex biological characteristics are difficult to fit the unique regulation of product specifications. Second, the quality-control data are related to the business confidentiality. Third, the requirements of constructing biopesticide factory needs to be clarified. Finally, shall biopesticides be listed as least-regulated pesticides? To solve above-mentioned problems, it is necessary to establish a single-desk unit to provide a pre-registration consultation and regulation advice and to set up the standard procedures of research, invention and registration for enhancing biopesticide development.

並列關鍵字

Biopesticide ； Agro-chemical management Act ； Microorganism agent ； Agro-chemical registration