Dev World Bioeth. 2019 Sep;19(3):148-154. doi: 10.1111/dewb.12211. Epub 2018 Dec 6.
Brazil is the biggest market for pesticides in the world. In the registration process, a pesticide must be authorized by the Institute of the Environment, Health Surveillance Agency and Ministry of Agriculture. Evaluations follow a package of toxicological studies submitted by the companies and also based on the Brazilian law regarding pesticides. We confronted data produced by private laboratories, submitted to the Institute of the Environment for registration, with data obtained from scientific databases, corresponding to mutagenicity, carcinogenicity and teratogenicity of pesticides. All studies submitted by the companies were carried out by private laboratories. From 247 pesticide formulations analyzed, none showed positive results for mutagenicity, carcinogenicity or teratogenicity. From 574 articles in the scientific literature, 84% published by public laboratories showed positive results, while 79% of those showing negative results came from private laboratories. There is an ethical concern about a conflict of interest between public/independent laboratories and private laboratories that produce data for registering pesticides. We demonstrated that there is a clear contradiction between public and private laboratories. Brazilian regulatory authorities have approved the registration of pesticides based almost exclusively on the monographs provided by the pesticide industry, because the use of scientific articles or information from the independent literature is strongly belittled by the industry. Pesticide companies argue that scientific articles cannot be trusted. Also, according to the industry, pesticide registration cannot be refused based on results from scientific articles. Thus, the registration of pesticides with mutagenic, carcinogenic and teratogenic risks has been approved in Brazil.
巴西是世界上最大的农药市场。在登记过程中，农药必须得到环境研究所、卫生监督局和农业部的批准。评估是根据公司提交的一整套毒理学研究报告进行的，同时也依据巴西的农药法规。我们将公司提交给环境研究所进行登记的数据与来自科学数据库的关于农药的致突变性、致癌性和致畸性的数据进行了对比。公司提交的所有研究都是由私营实验室进行的。在所分析的 247 种农药配方中，没有一种显示出致突变性、致癌性或致畸性的阳性结果。在 574 篇科学文献中，84%是由公共实验室发表的，显示出阳性结果，而 79%的阴性结果来自私营实验室。公共/独立实验室与生产农药注册数据的私营实验室之间存在利益冲突，这引发了伦理问题。我们证明了公共实验室和私营实验室之间存在明显的矛盾。巴西监管机构几乎完全基于农药行业提供的专论来批准农药登记，因为行业强烈贬低使用科学文章或独立文献中的信息。农药公司认为科学文章不可靠。此外，根据行业的说法，不能仅基于科学文章的结果拒绝农药登记。因此，具有致突变性、致癌性和致畸性风险的农药在巴西获得了登记。
