在欧盟注册除草剂需要对非目标陆生植物(NTTP)的风险进行评估。进行监管工厂研究以确定定量参数的风险评估相关终点(50%影响率),主要是生物量和存活率。最近,EFSA指出,定性评估植物视觉损伤(PVI)的终点,如坏死,萎黄病等.风险评估应考虑等于从定量确定的参数得出的端点。然而,NTTP测试指南中缺乏关于如何评估PVI以及如何得出有统计学意义的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.为了评估和提高可靠性,NTTP研究中PVI评估的可重复性和监管相关性,PVI工作组于2022年在SETAC工厂利益集团内成立。在第一次练习中,研究需要,确定了当前方法中的指导差距和缺点,并提出了未来的建议,经验证和协调的PVI评估方法。调查结果显示,目前评估PVI的方式存在很大差异,这些数据的可靠性尚不清楚。在当前条件下,PVI数据可以被视为支持性信息,而不是将其用于统计学上合理的调节终点的确定.因此,需要对评估PVI的程序进行标准化和统一。应该开发一种改进的评分方法,该方法允许精确、统计上合理的终点确定。关于PVI的监管相关性,需要进一步的研究来评估PVI数据的生物学意义,以及这与监管要求和保护目标的关系.最后但并非最不重要的,需要指导如何评估基于各种评估方法的历史上可用的PVI数据。
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).