Services

Environmental Fate & Exposure

Environmental fate and exposure evaluates how substances and their metabolites behave in soil, surface water, sediment, groundwater and air. We have expertise in conducting and evaluating all aspects of environmental fate and behavior data requirements. This includes overseeing, evaluating and responding to requests from regulatory agencies, conducting laboratory and field testing, evaluating and analyzing data, environmental fate and behavior modeling for estimating substance concentrations in various environmental media, and drafting waiver requests depending on product properties and use pattern.

Experienced Support For:

  • Global Regulatory Strategy
  • Study Design & Monitoring
  • Dossier Preparation & Submission
  • Regulatory Agency Liaison
  • Environmental Modeling & Risk Assessment
  • Risk Mitigation Measures & Strategies
  • Product Stewardship

Regulatory Strategy & Review

  • Reviewing, evaluating, and responding to an environmental fate characterization by a regulatory agency (e.g. a registration review)
  • Data gap analysis
  • Responding to a Data Call-In (DCI) including environmental fate data requirements (laboratory and field testing)
  • Drafting waivers for environmental fate testing requirements if applicable
  • Drafting summaries of a product’s environmental fate profile

Study Design, Placement & Monitoring

  • Design, placement, and monitoring of required environmental fate studies at Contract Research Organizations (CROs)
  • Overseeing synthesis of radio-labeled test material
  • Review and interpretation of study results, and review/audit of draft reports
  • Advice on Good Laboratory Practice (GLP)
  • Compliance with US Environment Protection Agency (EPA) and Organisation for Economic Co-operation and Development (OECD) pesticide registration guidelines, and Toxic Substances Control Act (TSCA) testing, as well as special (non-guideline) studies that may be required by a regulatory agency

Environmental Fate & Exposure Modeling

  • Determine Estimated Environmental Concentrations (EECs) of parent and relevant metabolites for use in ecological and human exposure and risk assessments
  • Data review to determine appropriate inputs for modeling
  • Standard modeling to define pesticide fate and transport includes:
    • Surface water: PWC
    • Groundwater: PRZM-GM
    • Spray drift: AgDrift; AgDISP; RegDisp
    • Aquatic: iStreem
    • Bioconcentration: KABAM
    • Drain: E-FAST
    • Dietary exposure: DEEM
  • (Q)SAR modeling, e.g. EPI Suite
  • Evaluate potential exposure and risks to birds, mammals and bees using EPA models that combine EEC and RQ (Risk Quotient) calculations:
    • T-REX avian and mammalian EEC and RQ modeling
    • TerrPlant non-target terrestrial plant EEC and RQ modeling
    • BeeRex pollinator EEC and RQ modeling
  • Determine potential aquatic and terrestrial exposure routes, and develop exposure profiles
  • Sensitivity analysis of model inputs
  • Design and develop customized models

Our environmental fate 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 environmental fate and behaviour 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 laboratory and higher-tier studies at contract research organizations
  • Review and interpretation of study results
  • Advice on compliance with Good Laboratory Practice (GLP)
  • Advice on Organisation for Economic Co-operation and Development (OECD) guidelines, as well as special (non-guideline) studies that may be required by a regulatory agency

Environmental Fate & Exposure Modeling

  • Determine Predicted Environmental Concentrations (PECs) of parent and metabolites for use in environmental and human exposure and risk assessments
  • Determine potential aquatic and terrestrial exposure routes and develop exposure profiles
  • Use of higher-tier refinements in exposure calculations
  • (Q)SAR modeling, e.g. OECD Toolbox, EPI Suite
  • Standard and custom modeling to define chemical fate and transport includes:

        Plant Protection Products:

  • FOCUS groundwater and surface water models (e.g. STEPS 1 & 2, PEARL, PELMO)
  • PERSAM soil exposure tool for the calculation of soil PECs
  • Higher tier refinements and national modeling approaches as required

        Biocidal Products:

  • EUSES
  • Emission Scenario Documents (ESDs) to estimate release of substances from biocidal products (e.g. PT1-4 Disinfectants, PT14 Rodenticides, PT18 Insecticides, Acaricides)
  • ECHA / Ad-Hoc Environment Exposure (AHEE) calculation methods

        REACH:

  • ECETOC TRA, Chesar and EUSES
  • Specific Environmental Release Categories (SpERCs)

Environmental Risk Assessment

  • Environmental fate inputs (e.g. PECs, soil, water, sediment and air DT50 values) to support risk assessment for aquatic and terrestrial non-target organisms
  • Evaluation of adsorption/desorption and leaching potential
  • Classification, Labelling and Packaging (CLP)
  • Persistent, Bioaccumulative and Toxic (PBT) / very Persistent and very Bioaccumulative (vPvB) assessments

Dossier Preparation

  • Preparation of relevant dossier sections to support EEA/UK active substance approvals and product authorisations including plant protection products, biocidal products and REACH
  • Data waivers and read-across/bridging arguments
  • Weight of evidence (WoE) reviews and expert statements
  • OECD format dossiers
  • Evaluation of public domain scientific literature and data in support of registration

Environmental Fate & Exposure Experts

Environmental Fate & Exposure

Steven Andrews

Senior Consultant

Scotland

Cliff Habig's Picture

Cliff Habig

Principal Consultant

Maryland/Maine

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Steven Andrews
Senior Consultant

Expertise: (Chemistry & Environmental Science)

Steven provides regulatory support of biocides, chemicals, and plant protection products with a focus on analytical methods and environmental risk assessment.

Steven previously served as Good Laboratory Practice (GLP) Study Director at Charles River Laboratories, specializing in Environmental Fate studies across a range of environmental matrices and conditions, and a range of compounds including agrochemicals, human pharmaceuticals, and veterinary products. As a GCP Laboratory Data Manager at Quintiles, Steven managed clinical trial data for therapeutic studies ranging in complexity and scale from 20 to >10,000 patients.

EDUCATION
BSc (Hons), Chemistry with Management, University of Edinburgh.

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

BS, Biology, University of Southern Maine.
MS, Biology, University of Georgia.
PhD, Environmental Toxicology, Duke University.