Agenda

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Join us virtually

  1. Welcome and introduction

    Moderator

    Nidia Mariana Calvo Mendez Nidia Mariana Calvo Mendez
    Americas Managing Analyst, Enhesa Product Intelligence
  2. Session 1: Updates from the EPA
  3. The EPA's antimicrobial divisions 2024 accomplishments and priorities for 2025

    • Overview of AD’s organizational structure, staffing updates, and scope of activities
    • Highlight AD’s FY24 accomplishments
    • Workload challenges, performance metrics, and process efficiencies
    • Overview of AD’s FY25 priorities
    Elizabeth Donovan Elizabeth Donovan
    Associate Division Director, Antimicrobials Division, US EPA
  4. The EPA registration review programme

    • The overall schedule for Reg Review.
    • Status of some of the larger cases, including quats and Its (isothiazolones)
    • How is EPA coordinating with other offices within EPA with respect to ethylene oxide and any other actives which involve multiple program offices
    • What is the status of the next round of reg review activities?  What compounds are being prioritized?
    • How is EPA integrating ESA considerations into antimicrobial registration review decisions
    Eric Miederhoff Eric Miederhoff
    Branch Chief, EPA US
  5. The EPA registration review programme

    • Current status
      • Schedule
      • Common takeaways from past registration review actions
    • Next Steps
      • ESA concerns
      • ED concerns
    Adrian Krygsman Adrian Krygsman
    Director Product Registration, Troy Corporation an Arxada Company
  6. Q&A session

  7. Refreshment break

  8. Session 2: Other US developments
  9. FIFRA: Registration issues and policy and post-election analysis

    • FIFRA Hot Topics
    • Registration Issues
    • Post-Election Analysis
    Heather F Collins Heather F Collins
    MS, Regulatory Consultant, Bergeson & Campbell, PC
    James V. Aidala James V. Aidala
    Senior Government Affairs Consultant, Bergeson & Campbell, PC
  10. Plans for applying ESA to antimicrobials

    • A brief overview of the Antimicrobials Division (AD) and the intersection of the different statutes that govern our work
    • Discuss AD’s approach to address the Endangered Species Act (ESA), both for registration review and registration of new chemicals, and the challenges we face
    • An update on the AD’s ESA efforts and what industry can do to help
    Charles (Chuck) Peck Charles (Chuck) Peck
    Senior Fate Scientist, Office of Pesticide Programs’ Antimicrobials Division, EPA
  11. Considerations in applying ESA to antimicrobials

    • Comparison with conventional agricultural pesticides: differences in antimicrobial uses and chemistries
    • Registrant challenges in providing relevant ESA information to EPA
    • Opportunities for further collaboration and feedback
    Anastasia Swearingen Anastasia Swearingen
    Executive Director, ACC Center for Biocide Chemistries
  12. Trends in pesticidal devices

    • COVID-19 and pesticide devices: EPA’s positioning
    • Public health labeling claims 
    • Substantiating product claims 
    • Imported devices
    • State regulation of devices
    Christine Donohue Christine Donohue
    Senior Managing Consultant, Ramboll
  13. Q&A session

  14. Lunch and networking

  15. Enhesa Product Intelligence service presentation and platform demo

  16. Welcome back

    Moderator

    Seth Goldberg Seth Goldberg
    Shareholder, Greenberg Traurig LLP
  17. Session 3: Further US developments
  18. Treated Articles: In situ active ingredients - the EPA expansion of what it considers actives and how that can impact innovation

    Diane Boesenberg Diane Boesenberg
    Senior Managing Scientist, Exponent
  19. Emerging pathogens

    • History of US EPA Emerging Viral Pathogen (EVP) guidance
    • Creation of Pesticide Program Dialogue Committee (PPDC) Emerging Viral Pathogen Workgroup (EVPWG)
    • Current PPDC Emerging Pathogen Implementation Committee (EPIC) structure and sunset
    • Accomplishments and final recommendations to EPA from PPDC EPIC communication/education and policy sub-workgroups
    • Update on the PPDC EPIC Technical Committee Efforts
    • Proposed changes for EVP Policy
    • Proposed policies for all other microbes
    • Final recommendations
    Rhonda Jones Rhonda Jones
    Chief Executive Officer, Scientific & Regulatory Consultants
    Tajah Blackburn Tajah Blackburn
    Senior Scientist, EPA
  20. Efficacy

    • Overview of EPA guidance and test method to support claims against planktonic Legionella pneumophila in cooling tower water
    • Discussion of draft EPA guidance for addition of viral claims to sanitizer products
    • EPA guidance documents/test methods anticipated in 2024 – 2025
    Denise Fernandez Denise Fernandez
    Senior Consultant, Scientific & Regulatory Consultants, Inc (SRC)
  21. Q&A session

  22. Refreshment break

  23. The impact of other programs on antimicrobials

    • The impacts of other EPA programs on the regulation of antimicrobials by the US EPA
    • How the TSCA program intersects with the FIFRA program
    • Discussion of how hazard assessments conducted by other program offices in EPA, including the Office of Research and Development, the Office of Air and Radiation, and the TSCA program, can impact antimicrobial assessments conducted by the pesticides program
    • Chemical examples used will include PFAS, Ethylene Oxide, and Formaldehyde
    Nancy Beck Nancy Beck
    Director of Regulatory Science, Hunton Andrews Kurth LLP
  24. PFAS and pesticides

    • Understanding the emergence of PFAS issues
    • Regulatory landscape and EPA actions
    • Current compliance requirements
    • Best practices for registrants
    Seth Goldberg Seth Goldberg
    Shareholder, Greenberg Traurig LLP
  25. Bilingual pesticide labeling

    • PRIA Coalition
    • PRIA 5 Bilingual Labeling Requirements
    • EPA Spanish Translation Guide
    • Stakeholder and Engagement Outreach
    • FAQs and considerations
    Ligia Duarte Iler Ligia Duarte Iler
    Senior Director, Regulatory Affairs, Household & Commercial Products Association
  26. Q&A session

  27. Refreshment break

  28. Data compensation and antimicrobials

    • Overview of the data compensation provisions under FIFRA
    • Complying with data compensation procedures
    • Data compensation disputes
    • Non-disclosure Agreements
    • FIFRA data compensation arbitrations
    Kaitlyn Maxwell Kaitlyn Maxwell
    Shareholder, Greenberg Traurig, LLP
  29. Canadian new biocides regulatory framework

    • Current Status
      • Implementation of key provisions
      • Effect on cost of registration
      • Revised active ingredient renewal process
    • Next Steps
      • What are registrants to do?  
    Adrian Krygsman Adrian Krygsman
    Director Product Registration, Troy Corporation an Arxada Company
  30. Q&A session

  31. Close of day