Safety information on transgenic plants expressing Bacillus thuringiensis-Derived insect control protein

This section summarises the information available on the source of Bacillus thuringiensis -endotoxin genes, the structure and properties of the toxins they encode, unique mechanisms of action, use in plants, toxicity and exposure data, and assessment methods. Some information on Bacillus thuringiensis, the bacterial source of these traits, is included as background and where relevant to the risk assessment of the -endotoxins in plants, however this section does not attempt to address the vast amount of information available on the micro-organism. In addition to the scientific literature, which grew substantially over the last few years, this section also contains data submitted by registration applicants for the US-registered plant pesticide products (called plant-incorporated protectants in US pesticide regulations). These studies are required to be performed according to good laboratory practices regulations (US Code of Federal Regulations 40 CFR 160) and have been peer reviewed by USEPA scientists for acceptability for use in an environmental assessment. In the US, data from these studies may be released to the public and are available from the companies on request by other regulatory bodies. Some of these data were submitted for products that are no longer registered; however, the data are still valid to illustrate -endotoxin properties. Where it is necessary to illustrate assessments unique to these toxin genes, plant expression data are discussed.

本节总结了有关苏云金芽孢杆菌内毒素基因来源、它们所编码毒素的结构和特性、独特的作用机制、在植物中的应用、毒性和暴露数据以及评估方法的现有信息。作为背景知识以及在与植物中内毒素的风险评估相关的方面，包含了一些关于苏云金芽孢杆菌（这些特性的细菌来源）的信息，然而本节并不试图涵盖有关该微生物的大量现有信息。除了在过去几年中大幅增长的科学文献外，本节还包含美国注册的植物农药产品（在美国农药法规中称为植物整合保护剂）的注册申请人提交的数据。这些研究需要根据良好实验室规范法规（美国联邦法规法典40 CFR 160）进行，并且已经由美国环保署的科学家进行同行评审，以确定其在环境评估中使用的可接受性。在美国，这些研究的数据可能会向公众公布，并且其他监管机构可应要求从相关公司获取。其中一些数据是为已不再注册的产品提交的；然而，这些数据对于说明内毒素特性仍然有效。在有必要说明这些毒素基因所特有的评估时，会对植物表达数据进行讨论。