我国生物农药行业发展比较缓慢,在发展过程中遇到很多问题:(1)行业集中度低;(2)我国生物农药企业不具备完整的农药开发筛选体系,生产与研发脱节;(3)产业化方面:制剂加工技术落后,提取技术不先进,原材料制约,质量标准缺少;(4)管理方面:登记资料规定方面存在不合理,要求过高;生物农药产品质量监管存在困难,非法添加非登记有效成分,缺乏统一的产品质量标准等。就全球范围看,美国是生物农药市场最成熟的国家。2011年,全球生物农药规模约为13～15亿美元,美国作为生物农药最大的市场,市场规模约占全球总规模的40%,达6亿美元左右,占美国农药销售额71亿美元的8.5%。这一比例在全球范围也是最大的。美国是世界上登记生物农药品种最多的国家之一,其登记生物农药包括由天然原料制成及风险较低的农药,大致分为:微生物农药(Microbial pesticide)、转基因植物(Plant-Incorporate-Protectants,PIPs)、生物化学农药(Biochemical pesticide)及部分化工产品等四类农药。为加强生物农药管理,引导生物农药产业发展,美国环保局(EPA)农药项目办公室(Office of Pesticide Programs,OPP)专门设立负责生物农药登记的管理部门,即生物农药与污染防治处(Biopesticides and Pollution Prevention Division,BPPD)。由于与传统化学农药相比,生物农药的风险较低,要求提供的登记资料相对较少,因此登记时间相对较快。但为了保证生物农药对人畜健康和环境的安全性,在登记时都会要求提供严格的资料,包括其组成、毒性、代谢及其它特性方面的数据。本文介绍美国1997年至2010年生物农药登记情况,从中发现天然产物和生物源农药是新活性成分创制战略的重要组成部分。尽管由于自身的性质,天然产物不适合用在农业生产上,但是科学家受到它们的启发,合成了大量的类似物,并筛选出高效、低毒的活性成分。旨在希望我国农药行业能够借鉴其成熟的经验、先进的理念和研发、生产工艺,加快我国相关行业的发展。 The development of bio-pesticide industry in China is relatively slow, and many problems have been encountered in the development process: (1) the industry concentration is low; (2) the bio-pesticide enterprises in China do not have a complete screening system for pesticide development and the production and research and development are out of step; (3) Aspects: the technology of preparation processing is backward, the technology of extraction is not advanced, the control of raw materials and the lack of quality standard; (4) Management: there are unreasonable and excessive requirements on registration data; the quality supervision of biological pesticide products is difficult, illegal addition of non-registration Active ingredients, the lack of uniform product quality standards. Globally, the United States is the most mature country in the bio-pesticide market. In 2011, the global scale of bio-pesticides was about 1.3-1.5 billion U.S. dollars. As the largest market for biological pesticides, the U.S. market is about 40% of the world’s total, reaching about 600 million U.S. dollars, accounting for 8.5 billion U.S. dollars of pesticide sales. %. This ratio is also the largest in the world. The United States is one of the most registered biopesticide species in the world. Its registered biopesticides include pesticides that are made from natural raw materials and are less risky and are broadly classified into Microbial pesticide, Plant-Incorporate-Protectants , PIPs), Biochemical pesticides and some chemical products. In order to strengthen the management of bio-pesticides and guide the development of bio-pesticide industry, the Office of Pesticide Programs (OPP) of the EPA set up a special management department responsible for bio-pesticide registration, that is, the Biopesticides and Pollution Prevention Division, BPPD). Due to the lower risk of biopesticides compared to traditional chemical pesticides and the relatively small amount of registration information required, registration times are relatively fast. However, in order to ensure the safety of biological pesticides to human and livestock health and the environment, strict information on registration, including composition, toxicity, metabolism and other characteristics, will be required. This article describes the registration of biopesticides in the United States from 1997 to 2010, from which it was discovered that natural products and biogenic pesticides are an important part of the strategy to create new active ingredients. Although natural products are not suitable for agricultural production due to their nature, scientists are inspired by them to synthesize a large number of analogues and to screen out highly active, low-toxic active ingredients. We hope that China’s pesticide industry can learn from its mature experience, advanced concepts and research and development, production technology, speed up the development of related industries in China.