Sector

Crop Protection

Since 1988, we have provided regulatory and environmental strategy support for crop protection products from bench to market and through end-user support. Regulatory requirements differ across the globe and are ever-changing. CSI is positioned to assist with all global regulatory and scientific needs.

In the US and Europe, we provide agrochemical firms with regulatory and scientific services to comply with the US Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the EU Plant Protection Products Regulation (EC) No 1107/2009. Additionally, we assist companies with fulfilling US State pesticide registration and European Economic Area (EEA) Member State and UK requirements. We support clients with global registration requirements, and have provided successful regulatory support in Canada, Latin America, South America, Asia, and Africa.

CSI develops environmental strategies to address ecological inquiries that arise during the pesticide development and registration process. We apply our extensive knowledge in agriculture, the regulatory arena, risk assessment, at-risk species, conservation measures, economics, and spatial analysis to provide comprehensive crop protection support for our clients.

Experienced Support For:

  • Global Regulatory Strategy
  • Dossier Preparation & Submission
  • Regulatory Agency Liaison
  • Human Health & Environmental Risk Assessment
  • Endangered Species Analysis & Strategy
  • Endocrine Disruptor Data Review
  • Task Force Representation & Administration
  • Applied Economic Analysis
  • Spatial Analysis & Data Systems

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 31st 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)

Crop Protection Experts

Robin Blake's Picture

Robin Blake

Principal Consultant

Scotland

Melinda Bowman's Picture

Melinda Bowman

Principal Consultant

California

Larry Brewer's Picture

Larry Brewer

Senior Science Fellow

Oregon

Ashlea Frank's Picture

Ashlea Frank

Principal Consultant

Florida

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Robin Blake
Principal Consultant

Expertise: (Registration Dossier)

Robin specializes in registration dossier preparation and plant protection product, biocide, and fertiliser risk assessments.

Robin previously worked for Cyanamid Agriculture UK and Syngenta for 12 years, conducting field trial, entomology, pesticide resistance, and herbicide research. He has extensive experience as a Good Laboratory Practice (GLP) Study Director in Terrestrial Ecotoxicology, specialising in laboratory, semi-field, and field trials on a range of non-target arthropods, earthworms, honeybees and non-target plants. His work often culminated in regulatory risk assessments in support of plant protection products.

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

Melinda Bowman
Principal Consultant

Expertise: Regulatory Affairs

Melinda has extensive experience in FIFRA regulatory compliance and product registration of agrochemicals and consumer products within the United States and Canada. She provides support and strategy for global pesticide registration actions, including support and coordination of the establishment of international MRLs, FDA 510(k) submissions and hand sanitizer listings.  She specializes in following new developments in regulatory compliance project management for EPA and FDA regulated products as well as agrochemical and pharmaceutical product development. 

EDUCATION
BS, Chemistry, San Francisco State University.

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 35 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, and pollinator 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
BS, Fish and Wildlife Biology, Iowa State University.
MS, Wildlife Science, University of Washington.

Ashlea Frank
Principal Consultant

Expertise: Endangered Species

Ashlea offers technical and regulatory planning and strategic support for risk and conservation decision-making related to agriculture, pesticides, and endangered species issues.

Ashlea enjoys finding workable solutions that support end users and promote environmental stewardship by integrating sound science with management decisions.  Over the past 20 years she has acted as Visiting Scientist at the Queensland Institute of Medical Research conducting research on the efficacy of vector control products and Research Assistant at the Texas A&M Extension Agency helping growers find solutions to plant disease transmission in vineyards. She serves as Technical Consultant to the FIFRA Endangered Species Task Force (FESTF) providing endangered species and pesticide data analysis and agency interaction support for regulatory decisions under the US FIFRA and the Endangered Species Act (ESA).

EDUCATION
BA, Physical Anthropology, Southwestern University.
MEnt (MS), Entomology, University of Queensland.