Programme
Welcome and introduction
Moderator
Session 1: Updates from the EPA
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
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
The EPA registration review programme
- Current status
- Schedule
- Common takeaways from past registration review actions
- Next Steps
- ESA concerns
- ED concerns
Q&A session
Refreshment break
Session 2: Other US developments
FIFRA: Registration issues and policy and post-election analysis
- FIFRA Hot Topics
- Registration Issues
- Post-Election Analysis
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
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
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
Q&A session
Lunch and networking
Enhesa Product Intelligence service presentation and platform demo
Welcome back
Moderator
Session 3: Further US developments
Treated Articles: In situ active ingredients - the EPA expansion of what it considers actives and how that can impact innovation
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
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
Q&A session
Refreshment break
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
PFAS and pesticides
- Understanding the emergence of PFAS issues
- Regulatory landscape and EPA actions
- Current compliance requirements
- Best practices for registrants
Bilingual pesticide labeling
- PRIA Coalition
- PRIA 5 Bilingual Labeling Requirements
- EPA Spanish Translation Guide
- Stakeholder and Engagement Outreach
- FAQs and considerations
Q&A session
Refreshment break
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
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?
Q&A session
Close of day