Environmental fate and exposure

The assessment of the environmental fate and behaviour of plant protection products is a critical part of the evaluation process under the European regulation (EC) No 1107/2009. We have extensive experience in higher tier exposure assessments of active substances and metabolites for the soil, surface water, groundwater and air environmental compartments. Together with in-house expertise in environmental modelling, field fate and spatial analysis, we offer a combination of specialist skills to propose options for refinement of modelling parameters. Favourable outcomes have been achieved through use of refined parameters, for example, resulting from kinetic analysis of soil dissipation data, measurement of drift and runoff parameters in the field, or contextualisation of results. This integrated approach provides solutions to address environmental fate regulatory issues.

E-fate and higher tier field studies

CEA are uniquely placed to provide our clients with ‘real world’ data to aid in regulatory submissions by undertaking higher-tier bespoke field studies specific to individual needs.

The availability of field derived (compound specific) data is becoming a crucial factor in demonstrating compliance with regulatory endpoints in situations not satisfactorily covered by current modeling frameworks. This is especially true when dealing with non-standard scenarios, compounds and uses.

CEA specialists are leaders in the design and execution of higher-tier field monitoring studies providing robust data sets in support of regulatory submissions. Our experienced team conduct GLP compliant studies at the laboratory, semi-field, field and catchment scale; aimed at quantifying pesticide residues in air, surface/ground water and soil.

Working closely with you to fully understand and identify your needs, we have a proven track record in designing and executing bespoke higher-tier field studies to suit your specific regulatory/post submission requirements for plant protection products and other chemicals.

CEA undertake regulatory risk assessments for the registration and re-registration of plant protection products (91/414/EC; 1107/2009/EEC) within the EU and its Member States. This encompasses all aspects of the registration process for active ingredients, co-formulants and plant protection products.

Close coordination between, and innovation within, the exposure modelling, ecotoxicology and field fate teams ensures maximum risk assessment refinement and increased prospects of regulatory success. Our environmental exposure modellers provide not only standard regulatory modelling, but have a well-earned reputation for providing higher tier, non-standard modelling support for challenging products in an increasingly demanding regulatory environment. We keep a watching brief on new and upcoming regulation, actively testing new models and guidance so that we have a thorough knowledge of the implications for client submissions as well as an understanding of potential higher tier refinement options.

CEA has extensive capability and experience in spatial analysis and statistics, offering a wide range of turnkey spatial and spatially explicit modelling solutions using a wide array of licensed software e.g. ESRI ArcGIS suite, SQL Server, Statistica/R to assist in policy support for European government and regulatory agencies and in the development of refined higher-tier/probabilistic landscape and catchment scale chemical exposure/effects/risk assessments to assist commercial clients in obtaining chemical registrations across Europe at both the EU and Member State levels, managing their post-registration product stewardship and assessing/managing the risks to their water assets/supply chain.

A good dossier provides a clear account of the environmental profile of a plant protection product. Starting with a data gap analysis for the proposed use pattern, we draw on backgrounds in industry and contract research to design and commission the studies required to address any deficiencies identified. Our experienced modellers, environmental fate, and ecotoxicology specialists work together to prepare the environmental sections of the dossier, and this integrated approach allows us to provide the most efficient solution to any areas of concern. Our experience encompasses a range of product types and environmental challenges.

Please contact us to discuss your agrochemical needs.