EPA Regulatory Affairs

• Regulatory strategies for FIFRA-regulated synthetic pesticide active substances (ingredients), biopesticides, and microbial products
• Agency liaison and negotiation, EPA registration, re-registration, and registration review package preparation and submission, including electronic submission through EPA's Central Data Exchange (CDX) system

State Registration Management

• First-time registration renewal and fee payment support approvals in all 50 states, District of Columbia, and US territories
• State submission packages (applications, labels, safety data sheets, technical data, reports, authorization letters, and product summaries)

Global Regulatory Strategy

• Identification of required studies to support registration intent and data gap analysis
• Placement and monitoring of tests at Contract Research Organizations (CRO), review and interpretation of study results, and assurance of compliance with Good Laboratory Practice (GLP) standards
• Preparation of data waivers
• Organisation for Economic Co-operation and Development (OECD) format dossiers

Environmental Fate & Ecotoxicology Data Review

• Classification, Labelling, and Packaging (CLP)
• Soil, water, sediment, and air DT50 values
• Adsorption/desorption and leaching potential
• Non-target organism toxicity endpoints and no observed effect concentrations (NOECs)

Applied Economics Support

• Extensive experience in production agriculture, economics, and conservation
• Pesticide use characterization and historical usage information
• Provide public comments on proposed registration decisions, developed use profiles, and other topics related to agriculture and pesticide uses
• Conduct economic impact analysis and develop benefit assessments

Endangered Species Analysis & Strategy

• Conduct assessments for species listed under the US Endangered Species Act (ESA) to determine potential effects from use of pesticides
• Use best available data to develop informed and defensible recommendations
• Combine economics, species status, conservation, and industry knowledge to assist clients in identifying solutions that are reasonable for the registrant and end-users and also protective of species
• Build and maintain collaborative relationships with multiple organization-levels within the USEPA, US Fish and Wildlife Service (FWS), US National Marine Fisheries Service (NMFS), US Department of Agriculture (USDA), state and regional-level agencies, and other entities

Spatial Analysis & Data Systems

• Compile, manage, and analyze data to apply the “where” to projects using Geographic Information Systems (GIS), databases, and programming
• Integrate a variety of data to provide a comprehensive picture of issues and to find reasonable solutions
• Organize layers of information into illustrations to facilitate communication
• Assess data for explanatory patterns and relationships

Task Force Representation & Administration

• Client representation on industry trade association consortia
• Serve in management, administrative, and lead technical roles on chemical task forces, including the FIFRA Endangered Species Task Force (FESTF)

Litigation Support

• Data compensation evaluations
• Intellectual property assessment
• Scientific case preparation
• Expert witness testimony

The Plant Protection Products Regulation (EC) No 1107/2009 applies to the European Economic Area (EEA) - the 27 EU Member States, plus Iceland, Liechtenstein and Norway - and imposes significant obligations on companies placing plant protection products on the EEA market.

Registration Dossier Preparation & Submission

• Preparation and submission of active substance dossiers for EEA registrations including synthetic pesticides, biopesticides, and microbial products for compliance with Plant Protection Product legislation
• Preparation and submission of product dossiers for EEA Member States (including zonal and mutual recognition), and Article 53 Emergency Authorisations
• Liaison with European regulatory agencies including European Food Safety Authority (EFSA), European Chemicals Agency (ECHA), and the European Commission, in addition to EEA Member State national regulatory authorities
• Support for Post Annex I (re-)registration
• Extensive experience with International Uniform ChemicaL Information Database (IUCLID)

Regulatory Strategy

• Identification of required studies to support registration intent and data gap analysis
• Placement and monitoring of tests at Contract Research Organizations (CRO), review and interpretation of study results, and assurance of compliance with Good Laboratory Practice (GLP) standards/Good Efficacy Practice (GEP) standards
• Preparation of data waivers
• Organisation for Economic Co-operation and Development (OECD) format dossiers

Hazard, Exposure & Risk Assessments for Human Health & Environment

• Extensive experience in all aspects of human health and environmental assessment
• Application of various models, including:  Chesar, ConsExpo, EUROPOEM, FOCUS, and PERSAM
• Quantitative Structure-Activity Relationship (QSAR) modeling, e.g. OECD Toolbox, EPI Suite
• Endocrine Disruptor (ED) assessments in accordance with EFSA/ECHA guidance
• Classification, Labelling and Packaging (CLP)

Litigation Support

• Data compensation evaluations
• Intellectual property assessment
• Scientific case preparation
• Expert witness testimony

Although the UK left the EU on 31^st January 2020, the Plant Protection Products Regulation was transposed into UK law almost unchanged, so the provisions of the Regulation apply in full in the UK.

Registration Dossier Preparation & Submission

• Preparation and submission of active substance dossiers for UK registrations including synthetic pesticides, biopesticides, and microbial products for compliance with Plant Protection Product legislation
• Preparation and submission of UK product dossiers, including national addenda and Article 53 Emergency Authorisations
• Liaison with UK national regulatory authority, and European regulatory agencies including European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and the European Commission
• Support for Post Annex I (re-)registration
• Extensive experience with International Uniform ChemicaL Information Database (IUCLID)

Regulatory Strategy

• Identification of required studies to support registration intent, data gap analysis, placement, and monitoring of tests at contract research organizations, review and interpretation of study results, and assurance of compliance with Good Laboratory Practice (GLP)/Good Efficacy Practice (GEP) standards
• Preparation of data waivers
• Organisation for Economic Co-operation and Development (OECD) format dossiers
• Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony

Hazard, Exposure & Risk Assessments for Human Health & Environment

• Extensive experience in all aspects of human health and environmental assessment
• Application of various models, including:  Chesar, ConsExpo, UK POEM, FOCUS, and PERSAM
• Quantitative Structure-Activity Relationship (QSAR) modeling, e.g. OECD Toolbox, EPI Suite
• Endocrine Disruptor (ED) assessments in accordance with EFSA/ECHA guidance
• Classification, Labelling and Packaging (CLP)