Higher-tier risk assessment

CEA has a well-earned reputation for helping clients find solutions for challenging ecotoxicological risk assessments. After reviewing and understanding the available data, we discuss the refinement options with you concerning likely success, regulatory acceptability and costs. We aim to develop a higher-tier risk assessment approach that balances your needs (timeline, budget and certainty) with the requirements of the risk assessment frameworks and regulatory authorities.

We provide an end-to-end service, including reviewing and comprehending the data, developing and scoping out solutions (including study design, monitoring, interpretation and implementation, where relevant), preparing the relevant documentation (e.g., stand-alone reports, dossier sections) and meeting with regulatory authorities. We are happy to collaborate with other experts, stakeholders and contract research organisations as required.

Some examples of past higher-tier risk assessment projects undertaken by CEA

• Reviewing existing chronic aquatic invertebrate studies for a PPP active substance with the aim of designing and monitoring Daphnia modified exposure studies based on predicted exposure profiles from FOCUSsw.
• Conducting higher-tier bird and mammal risk assessments and subsequently designing and monitoring field studies to refine exposure estimates for EU renewal of a granular fungicide.
• Deriving ecologically relevant endpoints for wild mammal reproductive risk assessments, in collaboration with our toxicology experts. We have presented on this topic at several conferences e.g., Brooks & Bull 2022.
• Use of existing higher-tier data, along with generic and publicly available data, to support a weight-of-evidence case for low risks to mammals for a herbicidal active substance for various uses in several target Member States.
• Designing, monitoring and interpreting residue decline studies on treated seeds and emergent seedlings, together with ecological refinements, to refine the risk assessment for birds and mammals for the renewal of a fungicidal active substance.
• Acting as lead ecotoxicology expert for an herbicidal active substance for a major PPP company, including active substance renewal and formulated product authorisations.