Ecotoxicological soil risk assessment under the new soil exposure framework - an impact assessment.

For the European risk assessment (RA) for soil organisms exposed to plant protection products (PPPs) endpoints from ecotoxicological laboratory studies are compared with predicted environmental concentrations in soil (PEC_SOIL) at first tier. A safety margin must be met; otherwise, a higher tier RA is triggered (usually soil organism field studies). A new tiered exposure modeling guidance was published by EFSA to determine PEC_SOIL. This work investigates its potential impact on future soil RA. PEC_SOIL values for >50 active substances and metabolites were calculated and compared with the respective endpoints for soil organisms to calculate the RA failure rate. Compared to the current (FOCUS) exposure modeling, PEC_SOIL values for all EU regulatory zones considerably increased, e.g., resulting in active substance RA failure rates of 67%, 58% and 36% for modeling Tier-1, Tier-2 and Tier-3A, respectively. The main driving factors for elevated PEC_SOIL were soil bulk density, crop interception and wash-off, next to obligatory modeling and scenario adjustment factors. Spatial PEC_SOIL scenario selection procedures result in agronomically atypical soil characteristics (e.g., soil bulk density values in Tier-3A scenarios far below typical European agricultural areas). Consequently, exposure modeling and ecotoxicological study characteristics are inconsistent, which hinders scientifically reasonable comparison of both in the RA.