Study design and monitoring

CEA has helped clients design various types of higher-tier studies that aim to address specific issues within wildlife risk assessments. We review the data and understand the specific issue before developing a study design. We aim to generate high-quality, robust data that address data gaps in the risk assessment or that address specific concerns raised by regulatory authorities.

Some examples of past higher-tier study design and monitoring projects undertaken by CEA

• Residue decline of seed treatment in treated seeds and resulting shoots. Trials placed across N-EU and S-EU. Data reviewed and DT50 values calculated to be used in bird and mammal risk assessment.
• Measured residues in seeds, worms and plant matrices following application of a granular formulation. Trials placed across N-EU and S-EU. Data used to refine the bird and mammal risk assessment.
• Modified exposure studies on non-standard aquatic macroinvertebrate species (Cloeon dipterum, Trichoptera sp.) to represent the predicted exposure profiles from FOCUSsw for a granular formulation, allowing the generation of Tier II NOECs to refine the chronic invertebrate risk assessment. Predicted exposure profiles generated and evaluated by CEA.
• Modified exposure studies on sediment dweller species (Chironomus riparius) to represent the predicted profile from FOCUSsw in terms of exposure in the sediment and overlying water, allowing the generation of a Tier II NOEC to refine the sediment dweller risk assessment. Predicted exposure profiles generated and evaluated by CEA.
• Selection of test species to construct an aquatic invertebrate species sensitivity distribution for acute exposure to an insecticidal formulation. Studies performed at CEA.