Supporting the development of exposure assessment scenarios for Non‐Target Terrestrial Organisms to plant protection products

EU Regulation 1107/2009 requires the risk assessment of several groups of non‐target organism (NTOs). To operationalize the rather generally defined protection goals in sectorial legislation, the concept of Specific Protection Goals (SPGs) has been developed. SPGs allow for an unambiguous definition of which ecosystem services need to be protected where and when. The evaluation of the SPGs is operationalised with the aid of Effect Assessment Goals (EfAG) and Exposure Assessment Goals (ExAG) that are assessed in a tiered approach, moving from simple and conservative lower tiers to more complex and more realistic higher tiers. The effect tiers specify ecotoxicological effects (observed for the imposed exposure in the ecotoxicological laboratory or (semi‐) field experiments) while the exposure tiers result in the exposure measured or simulated in the field. They are linked by the so‐called Ecotoxicologically Relevant Exposure Quantity, i.e. the type of exposure quantity that gives the best correlation to the observed ecotoxicological effect.

This document describes the relatively new concept of EfAG into detail, highlighting the importance of well defining the surrogate reference tier, that represents the highest, experimentally feasible tier of the effect assessment. The in regulatory science well known ExAGs have been defined for (small) mammals off‐field and Non Target Arthropods (NTAs) for one of the SPG options for NTAs, and may serve as an example for future guidance documents in this area.

In view of the evaluation of the SPGs that are currently defined for in‐field and off‐field situations, it is demonstrated that the area around the cropped treated field needs to be defined more precisely. Currently, the terms ‘in‐field’ and ‘off‐field’ are not sufficiently specific. This difference is important with respect to the estimation of spray drift deposition (often the main exposure route), which is based upon the distance to the last row of crop. Depending on the local setting, this distance can be similar or very different between an in‐field uncropped strip and off‐field. Such differences are not reflected adequately using the current distinction for ‘in‐field’ and ‘off‐field’. Therefore, we propose to introduce the terms of ‘in‐crop in‐field’, ‘off‐crop in‐field’, and ‘off‐crop off‐field’.