Services
Ecotoxicology & Risk Assessment
Our ecotoxicologists support a wide range of services to determine risks to wildlife and the environment including aquatic and terrestrial study design, ecological modeling and risk assessment, endangered species strategy and risk assessment, placement and monitoring of regulatory studies, and expert advice on product registration packages. Members of our team have served as study directors on laboratory, semi-field and field ecotoxicology studies, having direct experience with research and risk assessments involving non-target aquatic and terrestrial organisms.
In North America, we have significant organism-specific expertise and work closely with clients on diverse projects dealing with pollinator issues, avian & other vertebrate wildlife topics, and aquatic vertebrate & invertebrate topics.
In Europe, we have extensive experience of ecological risk assessments to support plant protection products, biocidal products and industrial chemicals (REACH) registrations.
Experienced Support For:
- Global Regulatory Strategy
- Study Design & Monitoring
- Dossier Preparation & Submission
- Regulatory Agency Liaison
- Ecological Risk Assessment
- Risk Mitigation Measures & Strategies
- Product Stewardship
- Endangered Species Strategy & Risk Assessment
- Endocrine Disruptor Data Review
Ecotoxicology & Risk Assessment Support in North America
Regulatory Strategy
- Risk assessment framework for product registration and registration review
- Agency liaison to define regulatory and technical approach
- Strategies for best use of data from guideline-driven laboratory and field studies
- Data gap analysis
- Risk mitigation measures & strategies
- Product stewardship
- Client representation on industry trade association consortia
- Serve in administrative and lead technical roles on chemical task forces, including the FIFRA Endangered Species Task Force (FESTF)
Study Design, Placement & Monitoring
- Design of standard and customized laboratory and field studies to support pollinator, avian and other vertebrate wildlife, aquatic data requirements
- Residue Studies (including pollen & nectar residue studies)
- Advice on welfare including animal husbandry and laboratory logistics
- Placement and monitoring of required ecotoxicology studies at Contract Research Organizations (CRO)
- Review and interpretation of study results, and Good Laboratory Practice (GLP) compliance consulting
- Compliance with Office of Prevention, Pesticides and Toxic Substances (OPPTS) and Organisation for Economic Co-operation and Development (OECD) testing methods
Ecological Risk Assessment
- Interpretation of study data and modeling of potential field exposure estimates
- Exposure Modeling and Spatial Analysis
- Environmental Impact Statements (EIS)
- Determination of optimal pesticide use and labeling specifications, (e.g., based on application of pollinator biology and crop flowering patterns)
- Endangered species assessment
Comprehensive Applications
- Evaluation of public domain scientific literature and data in support of registration
- Database compilation, management, and analyses
- Endocrine disruptor data review
- Weight of Evidence (WoE) reviews and expert statements
Ecotoxicology & Risk Assessment Support in Europe (EEA / UK)
Our ecotoxicology support services in Europe includes the European Economic Area (EEA), (i.e. EU27 Member States plus Iceland, Liechtenstein and Norway, and the United Kingdom).
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Regulatory Strategy
- Preparation of ecotoxicology registration strategies to support EEA/UK legislation including Plant Protection Products, Biocidal Products and REACH
- Data gap analysis
- Agency liaison to define regulatory and technical approach
- Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony
Study Design, Placement & Monitoring
- Design, placement, and monitoring of required ecotoxicology studies at contract research organizations
- Review and interpretation of study results, and Good Laboratory Practice (GLP) compliance consulting
- Compliance with OECD and SANCO testing methods
 Ecological Risk Assessment
- Standard assessments in accordance with EFSA/SANCO guidance for birds and mammals, aquatic organisms, Non-Target Arthropods (NTAs), Non-Target Plants (NTPs), bees and soil organisms
- Non-target organism toxicity endpoints and No Observed Effect Concentrations (NOECs)
- Toxicity:Exposure Ratios (TERs), Hazard Quotients (HQs) and Regulatory Acceptable Concentrations (RACs)
- (Q)SAR modeling
- Endocrine Disruptor (ED) assessments in accordance with European Food Safety Authority (EFSA)/European Chemicals Agency (ECHA) guidance
- Ecological modeling
- Higher-tier exposure and refinement
- Predicted Environmental Concentration (PEC)/Predicted No-Effect Concentration (PNEC) calculations and Assessment Factors
Dossier Preparation
- Preparation of relevant dossier sections to support EEA/UK active substance approvals and product authorisations for plant protection products, biocidal products and REACH
- Data waivers and read-across/bridging arguments
- Weight of evidence reviews and expert statements
- Organisation for Economic Co-operation and Development (OECD) format dossiers
- Evaluation of public domain scientific literature and data in support of registration
- Assessment of ecotoxicology hazards to support Classification, Labelling and Packaging (CLP)
- Preparation of Safety Data Sheets (SDS)
- Tier II ecotoxicology assessments to support technical equivalence applications