1. Registration

  2. Session 1: Focus on North America
  3. Keynote address - US EPA Antimicrobial Division

    • Priorities for FY’19
    • Registration Review Status
    • EPA’s Central Data Exchange (CDX) Portal
    • Antimicrobial Testing Program Update
    • Stakeholder Involvement
    Anita Pease Anita Pease
    Director, Antimicrobials Division, U.S. Environmental Protection Agency, USA
  4. An update on the activities of California EPA/DPP

    • Overview of the California Department of Pesticide Regulation - focus on the registration process
    • DPR Sanitizer Safety Outreach Program
    Teresa Marks Teresa Marks
    Chief Deputy Director, California Department of Pesticide Regulation
  5. An update on Proposition 65

    Carol J. Monahan Cummings Carol J. Monahan Cummings
    Chief Counsel, Office of Environmental Health Hazard Assessment (OEHHA)
  6. Q&A

  7. Refreshments

  8. Enforcement by the EPA

    Enforcement of antimicrobials in California

    Lucia Graham Lucia Graham
    Research Scientist, California Department of Pesticide Regulation
    Michel Oriel Michel Oriel
    Senior Environmental Scientist (Supervisory), California Department of Pesticide Regulation
    Royan Teter Royan Teter
    Chief of the Pesticides and Tanks Enforcement Branch (PTEB), U.S. EPA
  9. Antimicrobial Pesticides: Regulatory Update and Method Development Initiatives

    • Antimicrobial Pesticides
      • Regulatory summary
      • Updates to EPA guidance
      • New initiatives
    • Product efficacy – method development activities
      • Efforts with ASTM  
      • Quantitative Methods   
    Stephen Tomasino Stephen Tomasino
    Senior Scientist, U.S. Environmental Protection Agency
  10. Q&A

  11. Lunch

  12. Active Substance Approval in the US and EU

    • Active ingredient Definition in North America and the European Union
    • Application for Active ingredient authorisation
    • Common active ingredients in America and the EU
    • Biocidal Product definition in North America and the European Union
    • Application for biocidal product authorisation
      • Requirements: NA vs.EU
      • Timeline: NA vs. EU
      • Investment NA vs. EU
    Gosia Oledska Gosia Oledska
    Senior Regulatory Specialist Biocide EMEA, Ecolab
    Kate Sande Kate Sande
    Senior Manager – Innovation Product Registration & Toxicology, Ecolab
  13. Medical devices and the EPA/FDA Interface

    • What is a medical device?
    • FDA & EPA’s authority over medical devices
    • Defining intended use of device -- distinguishing between critical, semi-critical and non-critical devices
    Ann Marie Gaitan Ann Marie Gaitan
    Principal FDA Registration Specialist, Diversey, Inc.
  14. Q&A

  15. Refreshments

  16. Environmental Assessments & Endangered Species: Copper Case Study

    • Use and benefits of antifouling coatings
    • Consideration of environmental benefits
    • Quantification of environmental concentrations and effects
    • Method of assessing leach rates from antifouling coatings
    • Utilization of leach rate data and the MAMPEC model
    • EPA and state approaches to regulate copper antifouling coatings
    • Recommendation for a Comprehensive Regulatory Approach  
    Neal Blossom Neal Blossom
    Director of Quality Assurance and Global Regulatory Affairs, American Chemet Corporation, Chairman of the American Chemistry Council Copper Antimicrobial Task Force
    Anastasia Swearingen Anastasia Swearingen
    Director, Chemical Products and Technology, American Chemistry Council
  17. Global regulatory implications on product development and introductions

    A. Product Development is a multi-stage process:

    1. Idea stage
    2. feasibility/market assessment
    3. regulatory evaluation
    4. assessment
    5. test market
    6. Introduction

    B. Regulatory Role

    1. Involves an assessment of:
      • Actives
      • formulants
      • Market or region marketed
      • product purpose
      • Cost

    C. Case Example

    Adrian Krygsman Adrian Krygsman
    Director, Troy Corporation an Arxada Company
  18. Emerging Issues and Areas of Concern for Antimicrobials

    William McCormick III William McCormick III
    Research Fellow, Global Stewardship & Innovation, The Clorox Company
    Seth Goldberg Seth Goldberg
    Partner, Steptoe & Johnson LLP
  19. Q&A

  20. Close of Day One

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