Biocides USA 2018

• Priorities for FY’19
• Registration Review Status
• EPA’s Central Data Exchange (CDX) Portal
• Antimicrobial Testing Program Update
• Stakeholder Involvement

Anita Pease

Director, Antimicrobials Division, U.S. Environmental Protection Agency, USA

• Overview of the California Department of Pesticide Regulation - focus on the registration process
• DPR Sanitizer Safety Outreach Program

Teresa Marks

Chief Deputy Director, California Department of Pesticide Regulation

Enforcement of antimicrobials in California

Lucia Graham

Research Scientist, California Department of Pesticide Regulation

Michel Oriel

Senior Environmental Scientist (Supervisory), California Department of Pesticide Regulation

Royan Teter

Chief of the Pesticides and Tanks Enforcement Branch (PTEB), U.S. EPA

• Antimicrobial Pesticides
  • Regulatory summary
  • Updates to EPA guidance
  • New initiatives
• Product efficacy – method development activities
  • Efforts with ASTM  
  • Quantitative Methods   

Stephen Tomasino

Senior Scientist, U.S. Environmental Protection Agency

• 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

Senior Regulatory Specialist Biocide EMEA, Ecolab

Kate Sande

Senior Manager – Innovation Product Registration & Toxicology, Ecolab

• 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

Principal FDA Registration Specialist, Diversey, Inc.

• 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

Director of Quality Assurance and Global Regulatory Affairs, American Chemet Corporation, Chairman of the American Chemistry Council Copper Antimicrobial Task Force

Anastasia Swearingen

Executive Director, ACC Center for Biocide Chemistries

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

Director Product Registration, Troy Corporation an Arxada Company