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 consultants help clients navigate environmental fate requirements across EU and UK regulatory frameworks, providing strategic support from data gap assessment and exposure modelling through to regulatory submissions and authority interactions.

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