Suchergebnisse

AbstractBackgroundThe European environmental risk assessment of plant protection products considers aquatic model ecosystem studies (microcosms/mesocosms, M/M) as suitable higher tier approach to assess treatment-related effects and to derive regulatory acceptable concentrations (RAC). However, it is under debate to what extent these artificial test systems reflect the risks of pesticidal substances with potential harmful effects on natural macroinvertebrate communities, and whether the field communities are adequately protected by the results of the M/M studies. We therefore compared the composition, sensitivity and vulnerability of benthic macroinvertebrates established in control (untreated) groups of 47 selected M/M studies with natural stream communities at 26 reference field sites.ResultsSince 2013 the number of benthic macroinvertebrate taxa present in M/M studies has increased by 39% to a mean of 38 families per study. However, there is only an average of 4 families per study that comply with the recommendations provided by EFSA (EFSA J 11:3290, 2013), i.e.: (i) allowing statistical identification of treatment-related effects of at least 70% according to theminimum detectable difference(here criteria are slightly modified) and (ii) belonging to insects or crustaceans (potentially sensitive taxa for pesticidal substances). Applying the criterion of physiological sensitivity according to the SPEARpesticidesconcept, the number of families decreases from 4 to 2.3 per study.ConclusionsMost taxa established in recent M/M studies do not suitably represent natural freshwater communities. First, because their abundances are often not sufficient for statistical detection of treatment-related effects in order to determine an appropriate endpoint and subsequent RAC. Recommendations are given to improve the detectability of such effects and their reliability. Second, the taxa often do not represent especially sensitive or vulnerable taxa in natural communities in terms of their traits. The uncertainties linked to vulnerable taxa in M/M studies are especially high considering their representativity for field assemblages and the comparability of factors determining their recovery time. Thus considering recovery for deriving a RAC (i.e., ERO-RAC) is not recommended. In addition, this paper discusses further concerns regarding M/M studies in a broader regulatory context and recommends the development of alternative assessment tools and a shift towards a new paradigm.

Abstract
Background
The aim of environmental risk assessment (ERA) for pesticides is to protect ecosystems by ensuring that specific protection goals (SPGs) are met. The ERA follows a prospective tiered approach, starting with the most conservative and simple step in risk assessment (RA) (so-called tier 1) using the lowest available appropriate endpoint derived from ecotoxicological tests. In 2015, for the tier 1 RA of aquatic primary producers, the recommendation was changed from using the lowest of the 50% inhibition (EC50) values based on biomass (area under the curve—EbC50), increase in biomass (yield- EyC50) or growth rate (ErC50) to only using the growth rate inhibition endpoint (ErC50) because it is independent of the test design and thus more robust. This study examines the implications of this such on the level of conservatism provided by the tier 1 RA and evaluates whether it ensures a suitable minimum protection level.

Results
Our analysis shows that replacing the lowest endpoint with the growth rate inhibition endpoint while maintaining the assessment factor (AF) of 10 significantly reduces the conservatism in the tier 1 RA. Comparing protection levels achieved with different endpoints reveals that the current assessment is less protective. To maintain the previous level of protection, and since the protection goals have not changed, we recommend to multiply the default AF of 10 by an extra factor of minimum 2.4 in the tier 1 RA based on ErC50. Independently of the endpoint selected in tier 1 RA, several issues in the general RA of pesticides contribute to uncertainties when assessing the protection levels, e.g., lack of appropriate comparison of the higher tier experimental studies (i.e., best achievable approximation of field situation, so-called surrogate reference tier) with field conditions or the regulatory framework's failure to consider realistic conditions in agricultural landscapes with multiple stressors and pesticide mixtures.

Conclusions
We advise to consider adjusting the risk assessment in order to reach at least the previous protection level for aquatic primary producers. Indeed continuing using an endpoint with a higher value and without adjustment of the assessment factor is likely to jeopardize the need of halting biodiversity loss in surface waters.