Ecotoxicology & Risk Assessment

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).

 

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

Ecotoxicology & Risk Assessment Experts

Robin Blake

Robin Blake

Principal Consultant

United Kingdom

Larry Brewer's Picture

Larry Brewer

Senior Science Fellow

Oregon

Cliff Habig's Picture

Cliff Habig

Principal Consultant

Maryland/Maine

Jennifer Stafford's Picture

Jennifer Stafford

Principal Consultant

Washington State

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Robin Blake
Principal Consultant

Expertise: Registration Dossier

Robin specialises in regulatory affairs strategy and registration dossier preparation for plant protection products, biocides, and fertilisers.

Robin  has over 20 years’ experience in the Crop Protection industry and consulting sector, having previously held various R&D leadership positions at Syngenta and Cyanamid Agriculture UK. He has a broad range of expertise encompassing laboratory and field trials for efficacy, pesticide resistance, and herbicide research, as well as terrestrial ecotoxicology where he was a Good Laboratory Practice (GLP) Study Director specialising in laboratory, semi-field, and field trials on a range of non-target arthropods, earthworms, honeybees and non-target plants. 

EDUCATION
Ph.D., Agricultural Ecology, University of Reading.
BSc (Hons), Applied Biology, University of Bath.

Larry Brewer
Senior Science Fellow

Expertise: Terrestrial Ecotoxicology

Larry specializes in wildlife, pollinator, and endangered species risk assessment; pesticide registration/re-registration support; and regulatory study placement and oversight.

Larry has over 40 years of experience spanning terrestrial ecotoxicology, laboratory ecotoxicology testing, ecological risk assessment and endangered species assessment. He is well known for designing and implementing full scale (Tier III) ecotoxicology field studies throughout North America with particular focus on avian, small mammal, pollinator, and terrestrial invertebrate studies. Larry served as Director of Wildlife Toxicology for Smithers (17 years), and as President and Senior Scientist at Ecotoxicology and Biosystems Associates, Inc. directing domestic and international ecotoxicology field research, and ecological risk assessment (8 years). He was an Assistant Professor at the College of Human Health and Environmental Toxicology, Clemson University and the Wildlife Toxicology Section Lead in The Institute of Wildlife and Environmental Toxicology. He taught graduate courses in Wildlife Ecotoxicology and Field Research Techniques. He served as Field Research Leader for the Institute of Wildlife Toxicology, Western Washington University, and spent 17 years as a Wildlife Research Biologist with the Washington State Dept. of Wildlife. Larry has authored numerous publications and book chapters on topics of wildlife and pollinator ecotoxicology field research, and ecological risk assessment.

EDUCATION
M.S., Wildlife Science, University of Washington.
B.S., Fish and Wildlife Biology, Iowa State University.

Cliff Habig
Principal Consultant

Expertise: Ecotoxicology & Environmental Fate

Cliff provides consulting expertise for ecological risk assessments, endangered species analyses, and endocrine disruptor (EDSP) evaluations.

Cliff has over 25 years of experience in ecotoxicology, environmental fate, and strategic support to US and international clients for conventional crop protection products, biochemicals, microbials, biotechnology products, and HPV chemicals. Cliff previously worked at Novigen, JSC, and Exponent, focusing on environmental toxicology, ecological risk assessment, higher-tier ecotoxicology evaluations, and probabilistic chemical fate and transport modeling and risk analysis. Cliff participated in numerous chemical industry workshops and expert panels.

EDUCATION
Ph.D., Environmental Toxicology, Duke University.
M.S., Biology, University of Georgia.
B.S., Biology, University of Southern Maine.

Jennifer Stafford
Principal Consultant

Expertise: Regulatory Compliance, Terrestrial Ecotoxicology, & Wildlife Science.

Jennifer leads CSI’s US Regulatory Affairs team, managing FIFRA and non-FIFRA (crop nutrition) product registrations, including those for biocides and biologicals. Jennifer participates in projects related to ecotoxicology, wildlife biology/ecology, GLP Compliance, database management, and USEPA guideline study management. Jennifer’s skills support regulatory staff, pesticide risk assessment, and endangered species assessments.

Jennifer has over 28 years of field research and laboratory ecotoxicology experience, including 20 years of Good Laboratory Practice (GLP) avian and wildlife study directorship and laboratory management. She has extensive experience interpreting the difference between animal behavior in the wild versus in captivity, and how these differences impact study design, husbandry practices and test results.  She has experience with developing and utilizing large data sets and is thoroughly familiar with EPA and OECD regulatory testing guidelines, Good Laboratory Practices guidelines, EPA and OECD guidance on pesticide risk assessment and EPA process for endangered species Biological Evaluation.

EDUCATION
M.S., Biology/Ecology, Utah State University.
B.S., Environmental Biology, Grand Canyon University.