Risk assessment for Birds and Mammals

Abstract

The European Commission asked EFSA to revise the Guidance on the risk assessment for birds and mammals. That guidance described how to perform risk assessment for birds and mammals from plant protection products, containing pesticide active substances, in accordance with Regulation (EU) 1107/2009. The current guidance document is an update of EFSA's existing guidance document titled ‘Risk assessment for Birds and Mammals’ which was published in 2009. It outlines a tiered risk assessment scheme covering dietary exposure, exposure via secondary poisoning and exposure via intake of contaminated water.

Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

“…Once the slope is fixed, a surrogate LD50 can be derived by multiplying the highest (or single) tested dose to an appropriate extrapolation factor, depending on the observed effect. This is conceptually similar to the extrapolation factors for LD50 reported in the guidance document for birds and mammals (EFSA, 2023 ). For sake of simplicity and conservativeness, the observed effects are categorised into five effect intervals, with the higher end being used for derivation of extrapolation factors.…”

“…Although such ecological effects are relevant and should be addressed, this guidance document only considers direct toxicity‐mediated effects. The ecological effects can be addressed by ensuring that future EFSA guidance documents for PPP risk assessment sufficiently consider the supporting ecosystem service ‘food‐web support’ for bees (EFSA, 2023 ).…”

Using emerging science to inform risk characterizations for wildlife within current regulatory frameworks

“…In addition, the potential for in silico models is recognized in the most current EFSA guidance including the EFSA aquatic guidance (EFSA, 2013) and the EFSA bird and mammals guidance (EFSA, 2023), where toxicokinetics/toxicodynamics (TK/TD) and dynamic energy budget modeling are specifically considered, along with population modeling to better elucidate population and multigenerational effects. Some types of in silico modeling require specific toxicity tests or endpoints and are therefore best and/or easiest applied to nonvertebrates in the interest of minimizing vertebrate testing, and yet, specific models have not yet been incorporated.…”

Statement on the refined environmental risk assessment and impact of the new classification for captan

“…The risk assessments considering the reduced application rate by 60.7% resulted in high risk for both representative uses of captan (6 applications of 1.2 kg a.s./ha at BBCH 51–85 to pome fruits and 2 applications of 1.8 kg a.s./ha at BBCH 53–87 to cherries). Additional refinement options were considered: (1) 20% reduction of spray volume deposition to ground vegetation, and (2) RUD values according to the EFSA's Guidance Document on Birds and Mammals (EFSA, 2023). With these refinements, a low risk was demonstrated for the two representative uses under reconsiderations.…”