Veterinary Medicines

    CEA specialises in understanding the fate, effects and risks of veterinary medicinal products released into the environment. Currently we have an environmental representative (Dave Arnold) on the veterinary products committee (VPC) in the UK.

    We have resources to support clients with desk based exposure and risk assessments as well as a wide range of field based environmental investigations including higher-tier regulatory studies. CEA are able to assess existing data packages against regulatory requirements, provide Expert Reports under the Directive 2001/82/EC and provide additional interpretation of complex high-tier studies.

    We have a proven track record in the provision of support to industry clients with VICH environmental requirements necessary under Directive 2001/82/EC, for both livestock and aquaculture products.

    Key Skills:

    • Data evaluation and regulatory support
    • Evaluating the risk to the aquatic and terrestrial environment
    • Development of emission scenarios and exposure pathways
    • Modelling the potential for environmental exposure of fish medicines used in aquaculture
    • Calculation of predicted environmental concentrations (PECs) following the use of products in livestock
    • Higher-tier aquatic and terrestrial field studies
    • Identifying risk reduction strategies

    Recent Studies:

    • Expert review of ecotoxicity data as required as a component of the registration/re-registration of veterinary medicines in the European Union (EU) according to Directive 81/852/EEC (superseded by Directive 2001/82/EC)
    • Assessment of the potential for environmental exposure to active substances or relevant metabolites as required for Phase I of the risk assessment process for a veterinary medicine
    • Use of both lower- and higher-tier modelling approaches to estimate potential exposure to surface and groundwaters, including the porewater calculation method, the FOCUS modelling suite and the VetCalc tool
    • Production of an environmental risk assessment for veterinary medicines used in aquaculture including predictions of aquatic and benthic exposure to facilitate a Risk Quotient (RQ) approach as required for Phase II of the regulatory process. The project included a review of available ecotoxicity data and identification of appropriate strategies for refinement. In this case CEA, in negotiation with the regulatory authority and the client, designed and monitored ecotoxicology tests to address uncertainty in order to secure successful registration.