Fellmann Sebastian, Duffner Andreas, Kirkwood Ashlee, Lopez-Mancisidor Patricia, Arnie Joshua, Krueger Henry, du Hoffmann Gunther, Wolf Jeffrey, Kraetzig Gwendolin, Springer Tim, Isemer Rena
Bayer AG, Crop Science Division, Monheim, Germany.
Eurofins Agroscience Services Ecotox GmbH, Niefern-Öschelbronn, Germany.
Integr Environ Assess Manag. 2024 Jul;20(4):915-923. doi: 10.1002/ieam.4855. Epub 2023 Nov 7.
The registration of herbicides in the European Union requires an assessment of risks to nontarget terrestrial plants (NTTPs). Regulatory plant studies are performed to determine risk-assessment-relevant endpoints (50% effect rate) for quantitative parameters, mostly biomass and survival. Recently, the European Food Safety Authority stated that endpoints for qualitatively assessed plant visual injuries (PVIs) such as necrosis, chlorosis, and so forth should be considered for the risk assessment as equal to endpoints derived from quantitatively determined parameters. However, the lack of guidance in the NTTP test guidelines on how to assess PVI and how to derive a statistically meaningful endpoint for PVI makes their use in risk assessments challenging. To evaluate and improve the reliability, reproducibility, and regulatory relevance of PVI assessments in NTTP studies, the PVI Working Group was formed in 2022 within the SETAC Plant Interest Group. In a first exercise, research needs, guidance gaps, and shortcomings in current methodologies were identified and are presented together with recommendations for a future, validated, and harmonized method for the assessment of PVI. Survey results revealed a high variability in how PVI are currently assessed, and that the reliability of these data is unclear. Under current conditions, the PVI data can rather be seen as supportive information instead of using the data for the statistically sound determination of a regulatory endpoint. Consequently, standardization and harmonization of procedures for the assessment of PVI are needed. An improved scoring methodology should be developed that allows for a precise, statistically sound endpoint determination. Regarding the regulatory relevance of PVI, further research is required to assess the biological meaning of PVI data and how this is connected to the regulatory requirements and protection goals. Last but not least, guidance is required on how to evaluate the historically available PVI data that are based on various assessment methodologies. Integr Environ Assess Manag 2024;20:915-923. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
在欧盟，除草剂的注册需要评估对非靶标陆生植物（NTTPs）的风险。开展监管性植物研究以确定定量参数（主要是生物量和存活率）与风险评估相关的终点（50%效应率）。最近，欧洲食品安全局指出，在风险评估中，应将定性评估的植物视觉损伤（PVI）终点（如坏死、黄化等）视为与定量测定参数得出的终点同等重要。然而，NTTP测试指南中缺乏关于如何评估PVI以及如何得出具有统计学意义的PVI终点的指导，这使得它们在风险评估中的应用具有挑战性。为了评估和提高NTTP研究中PVI评估的可靠性、可重复性和监管相关性，2022年在SETAC植物兴趣小组内成立了PVI工作组。在首次工作中，确定了当前方法中的研究需求、指导空白和不足，并与未来用于评估PVI的经过验证和统一的方法建议一起呈现。调查结果显示，目前对PVI的评估方式存在很大差异，且这些数据的可靠性尚不清楚。在当前条件下，PVI数据更应被视为支持性信息，而非用于基于统计学合理地确定监管终点。因此，需要对PVI评估程序进行标准化和统一。应开发一种改进的评分方法，以便能够精确、基于统计学合理地确定终点。关于PVI的监管相关性，需要进一步研究以评估PVI数据的生物学意义以及其与监管要求和保护目标的联系。最后但同样重要的是，需要关于如何评估基于各种评估方法的历史可用PVI数据的指导。《综合环境评估与管理》2024年；20:915 - 923。© 2023作者。《综合环境评估与管理》由Wiley Periodicals LLC代表环境毒理学与化学学会（SETAC）出版。
