Environmental Risk Assessment of Plant Protection Products, Biocides, Chemicals, Veterinary Medicines & Pharmaceuticals in the EU
Assessing the potential effects on individual organisms, natural communities and ecosystems is integral to the regulation of pesticides, biocides and industrial chemicals. In many cases, potential effects on the environment are the main driver in decisions regarding uses of a chemical.
Due to increasing regulation and complexity and constant revision of regulatory guidance, the processes and methods for conducting environmental risk assessments for plant protection products (EU Regulation 1107/2009), biocides (Biocidal Products Regulation 528/2012), industrial chemicals (REACH Regulation 1907/2006), veterinary medicines (EU Directive 2001/82/EC) and pharmaceuticals (EU Directive 2001/83/EC) are becoming a greater challenge, both in terms of estimating potential environmental exposure, and in utilising toxicity data generated on non-target organisms to assess the potential risk.
The available data on the fate and behaviour, as well as the effects of a chemical in the environment (including their metabolites or other substances of concern), can differ markedly depending on the regulatory regime and the nature of the chemical.
Exponent’s Expertise in Environmental Risk Assessments
Exponent assists clients in their environmental risk assessments in numerous ways, and meets the needs of our clients based on our in-depth knowledge in the conduct and evaluation of such studies gained from a variety of backgrounds (regulatory authorities, industry and CROs).
Our expertise enables us to choose the appropriate course of action, place the study at an appropriate laboratory, and monitor the study to ensure a robust data package and environmental risk assessment.
Our services include:
- Strategic advice on testing options and on registerability
- Active substance and product dossier preparation, including Member State specific requirements
- Study design and management of environmental fate and ecotoxicology studies
- Stand-alone expert papers
- EFSA literature reviews
- Support at meetings with regulatory authorities
- Post submission support
- Use of QSARs to generate environmental fate and ecotoxicology parameters and support read across
- Predicted No Effect Concentration (PNECs) determination
- PBT assessment.
Environmental Fate and Exposure Services
Some of the key highlights our environmental fate consultants can offer are as follows:
- Plant Protection Products:
- Use of the FOCUS groundwater and surface water tools (including higher tier refinements and EU MS national modelling approaches)
- Use of the PERSAM soil exposure tool for the calculation of PECs in soil
- Study design and management of higher tier studies, ranging from laboratory studies to address specific concerns, to the design of larger scale field studies
- Use of EUSES
- Experience in the evaluation of the ESDs for the vast majority of biocide PTs [including PT2 (disinfectants), PT18 (insecticides) and PT14 (rodenticides)]
- Use of higher tier refinements and arguments to refine the exposure calculations
- Evaluation of the exposure arising from a broad variety of industry sectors
- Use of ECETOC TRA, Chesar and other first tier models and the use of EUSES in combination with other strategies to refine the exposure estimates
- Veterinary Medicines
- Calculation of predicted environmental concentrations (PECs) in accordance with the VICH phases I & II guidelines
Some of the key services our ecotoxicologists can offer include:
- Study design and management of higher tier aquatic and terrestrial ecotoxicology studies, including:
- Modified exposure studies
- Additional species testing (including species sensitivity distributions)
- Semi-field and field studies (including aquatic mesocosms and bee studies)
- Field monitoring (including bird surveillance programmes)
- Plant protection products:
- Standard and higher tier risk assessments, including in-depth knowledge of EFSA’s Aquatic Guidance Document (2009) and EFSA’s Bee Guidance Document (2013).
News & Events