Overview of PMRA Structure and Submission Process

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Richard Aucoin, Ph.D.
Executive Director

Pest Management Regulatory Agency/Agence de réglementation de la lutte antiparasitaire de Santé

Chief Registrar's Office/Registration Directorate

• Chief Registrar/Director General
  • Ensures that the PMRA makes integrated, science-based registration decisions
  • Manages registration issues and appeals
  • Chairs Science Management Committee (SMC)
  • Monitors operations, including Management of Submissions Policy and performance standards, and
  • Provides strategic, operations, and policy advice
  • Directorate consists of two Divisions:
    • Submission Information and Management Division
    • Review and Science Integration Division

Registration Directorate/Submission Information and Management Division

• Manages and tracks submissions
• Coordinates pre-submission consultations
• Manages submission and product information including CBI (Oracle database and paper files), and manages the public registry and electronic environment
• Labelling issues and programs
• Manages the application of the Formulants Policy

Registration Directorate/Review and Science Integration Division

• Coordinates the submission management process, including coordination of the science reviews
• Prepares documentation to meet the PCPA transparency requirements
• Develops processes and procedures to facilitate worksharing and harmonization of pesticide reviews and
• Reviews Category C submissions

Value and Sustainability Assessment Directorate

• Value assessments (efficacy, crop tolerance, benefits, resistance management, etc.)
• Use information
• Risk reduction and transition strategies development
• Minor use submissions (URMULES)
• Stakeholder engagement (user sectors)

Health Evaluation Directorate

• Human health risk assessments
  • Toxicology
  • Dietary/food residue
  • Occupational/bystander exposure
  • Maximum residue limits
• Incident reporting
• Science policy development

Environmental Assessment Directorate

• Evaluates data on the environmental chemistry and toxicology of products, as well as their environmental fate
• Provides expertise on environmental hazards, risk assessments and risk mitigation
• Participates in national and international activities to facilitate harmonization of testing and evaluation procedures
• Science policy development

Re-evaluation Management Directorate

• Ensures that the PMRA makes integrated, science-based re-evaluation decisions
• Manages re-evaluation issues
• Liaises with registrants and other stakeholders on re-evaluation issues; and transition strategies
• Manages and tracks re-evaluations and prepares consultation documents

Compliance, Laboratory Services and Regional Operations Directorate

• Laboratory Services performs guarantee, formulation and residue analyses in support of the PMRA's compliance programs
• Evaluate the product chemistry data that companies must provide as part of submissions for registering any pest control product
• PMRA Regional Offices promote, verify and enforce compliance with the PCPA through investigations, inspections and consultations
• Investigate the manufacturing, use, sale and importation of products
• Collaboration with ODGs (provinces, CFIA)

Strategic Planning, Financial and Business Operations Division

• Responsible for planning
• Responsible for implementation of the departmental/Agency financial management policies, financial planning, accounting and budgeting
• Responsible for the Agency multi-year planning and accountability framework
• Learning and development
• Cost recovery

Policy, Communications and Regulatory Affairs Directorate

• Develops federal policy and legislation for pest control products
• Manages communications and publications for PMRA
• Coordinates national and international activities of PMRA
• Stakeholder engagement, including the Minister's Pest Management Advisory Council (PMAC) and Federal/Provincial/Territorial (FPT) relations
• Economic analysis for regulations

Overview Of Submission Process

• Receipt, verification, and screening
  • Loading into databases
  • Required elements addressed and adequate
    • Cover letter
    • Application
    • Specification forms, fees
    • Letters of access
    • Labels
    • Data, rationales, waiver requests
    • Verify purpose and category, precedents?
  • Deficiencies?
  • Preliminary Review
    • Forward to review divisions (if necessary) for preliminary review
      • Conditionally required elements
      • Study acceptability
      • Value and chemistry reviews done early
      • Deficiencies
  • Evaluation
    • Reviews and peer reviews of all disciplines
    • Risk assessments and label statements verified/revised
    • Coordination, integration of science assessments, labels
    • Regulatory document preparation (final reviews, consultation documents
  • Decision-Making and Certificates
    • SMC for new actives (major new uses); emergency requests
    • Value, risk and risk management considerations