Key for more realistic risk assessments?
On August 23, EFSA released their “Scientific Opinion on the state of the art of Toxicokinetic / Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms”. What does this mean for PPP registration dossiers?
TKTD models mathematically describe the processes involved in the uptake and elimination of a toxicant (TK) and how the toxicant affects the organism (TD) or, in other words, what the body does to the chemical and what the chemical does to the body. In the tiered approach of PPP risk assessment, TKTD models can be viewed as an intermediate tier (tier 2), requiring standard toxicity tests for their calibration but enabling the evaluation of any number of exposure profiles without the need of additional testing. In practice, this means that for PPP dossiers TKTD models can be applied if the tier 1 and tier 2 toxicity tests indicate risk, possibly avoiding higher tier (mesocosm) testing.
This scientific opinion demonstrates the increased interest of regulatory authorities for modelling alternatives in effect assessment. At Arche Consulting, modelling experts are available for you with broad experience in TKTD modelling. In the ChimERA project, TKTD models were used to simulate community effects under realistic exposure scenarios and in the EcoRelevance project, metal toxicity is extrapolated from standard toxicity tests to populations using ecological and TKTD modelling.
Together with our broad experience in PPP dossiers, Arche Consulting is ideally suited to advise you on PPP dossiers. Do not hesitate to contact us how this new approach can help you with your registration dossiers.
Read the scientific opinion here.