Department of Environmental Science, Stockholm University, Stockholm, 10691, Sweden.
Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, 11883, Sweden.
Environ Health. 2023 Jun 1;22(1):44. doi: 10.1186/s12940-023-00994-9.
In the European Union (EU), the safety assessment of plant protection products relies to a large extent on toxicity studies commissioned by the companies producing them. By law, all performed studies must be included in the dossier submitted to authorities when applying for approval or renewal of the active substance.
For one type of toxicity, i.e. developmental neurotoxicity (DNT), we evaluated if studies submitted to the U.S. Environmental Protection Agency (EPA) had also been disclosed to EU authorities.
We identified 35 DNT studies submitted to the U.S. EPA and with the corresponding EU dossiers available. Of these, 9 DNT studies (26%) were not disclosed by the pesticide company to EU authorities. For 7 of these studies, we have identified an actual or potential regulatory impact.
We conclude that (1) non-disclosure of DNT studies to EU authorities, in spite of clear legal requirements, seems to be a recurring phenomenon, (2) the non-disclosure may introduce a bias in the regulatory risk assessment, and (3) without full access to all performed toxicity studies, there can be no reliable safety evaluation of pesticides by EU authorities. We suggest that EU authorities should cross-check their data sets with their counterparts in other jurisdictions. In addition, applications for pesticide approval should be cross-checked against lists of studies performed at test facilities operating under Good Laboratory Practice (GLP), to ensure that all studies have been submitted to authorities. Furthermore, rules should be amended so that future studies should be commissioned by authorities rather than companies. This ensures the authorities' knowledge of existing studies and prevents the economic interest of the company from influencing the design, performance, reporting and dissemination of studies. The rules or practices should also be revised to ensure that non-disclosure of toxicity studies carries a significant legal risk for pesticide companies.
在欧盟（EU），植物保护产品的安全评估在很大程度上依赖于生产它们的公司委托进行的毒性研究。根据法律，所有进行的研究都必须包含在公司向当局提交的申请批准或续展有效物质的文件中。
对于一种毒性，即发育神经毒性（DNT），我们评估了提交给美国环境保护署（EPA）的研究是否也向欧盟当局披露。
我们确定了 35 项提交给美国 EPA 的 DNT 研究，并且有相应的欧盟文件可供查阅。其中，9 项 DNT 研究（26%）未被农药公司向欧盟当局披露。对于其中的 7 项研究，我们已经确定了实际或潜在的监管影响。
我们的结论是：（1）尽管有明确的法律要求，但不向欧盟当局披露 DNT 研究似乎是一个反复出现的现象；（2）不披露可能会对监管风险评估引入偏差；（3）如果没有对所有进行的毒性研究进行全面的了解，欧盟当局就不可能对农药进行可靠的安全评估。我们建议欧盟当局应与其他司法管辖区的对应部门核对其数据集。此外，应根据在遵守良好实验室规范（GLP）的测试设施中进行的研究清单核对农药批准申请，以确保所有研究都已提交给当局。此外，应修订规则，以便未来的研究应由当局而不是公司委托进行。这确保了当局对现有研究的了解，并防止公司的经济利益影响研究的设计、执行、报告和传播。规则或做法也应进行修订，以确保不披露毒性研究对农药公司承担重大法律风险。
