Accessible by: anyone
Thirteenth Antimicrobial Workshop
May 12-13, 2020
Hyatt Regency Crystal City
2799 Richmond Highway
Arlington, VA 22202
Day One—May 12, 2020: Preliminary Agenda
7:30 a.m. – 8:30 a.m. Registration and Continental Breakfast
8:30 a.m. – 8:40 a.m. Welcoming Remarks
Moderator Day One: Rhonda Jones, SRC
8:40 a.m. – 9:00 a.m. State of the Antimicrobial Division
Antimicrobial Division Director, Anita Pease, will lead off the Workshop by providing an overview of the Division’s current priorities and activities as well as a glimpse into its future directions. Director Pease will touch upon recruiting and retaining AD staff, PRIA and registration activities, the antimicrobial performance evaluation program, Section 810 product performance guidelines and the disclosure of inert ingredients.
Anita Pease, Director, Antimicrobials Division, EPA Office of Pesticide Programs (OPP)
9:00 a.m. – 9:30 a.m. An Update on Registration Review
EPA’s Registration Review program is designed to ensure that products in the marketplace, including antimicrobial pesticides, are efficacious and can still be used safely without unreasonable risks to public health or the environment. This session will provide an update on EPA’s schedule for registration review of antimicrobials and will also address how Section 158W data might affect the outcomes of draft risk assessments. EPA will also discuss the need for registrant information and feedback on the alternatives and benefits of active ingredients and the need for information to refine any risk calculations that may not reflect current registered labeled uses.
Rick Fehir, Ph.D., Team Leader and Jose Gayoso, Senior Regulatory Advisor, Antimicrobials Division, EPA Office of Pesticide Programs (OPP) (invited)
9:30 a.m. – 10:30 a.m. Implementation of 810 Product Performance Test Guidelines
On Aug. 28, 2019, the 2018 810 guidelines for 810.2000 General Considerations, 810.2100 Sporicidal Testing, and 810. 2200 Disinfectant Testing were implemented with a new “Series 810 Guidelines FAQ” guidance. All efficacy testing must now comply with these documents though EPA will provide certain limited exceptions. This session will provide a summary of the changes and clarifications provided by the 2019 “Series 810 Guidelines FAQ” document with a look at some test cases.
Tina Pham, Efficacy Evaluation Team, Antimicrobials Division, EPA Office of Pesticide Programs (OPP) (invited)
10:30 a.m. – 11:00 a.m. Networking Break
10:30 a.m. – 11:00 a.m. Confirmatory Efficacy
This session will cover the recently published draft Confirmatory Efficacy sections of the 810 Guidelines. The Confirmatory Efficacy guidance was separated from the rest of the 810 Guidelines that were implemented in August 2019. This session will discuss the changes to the Confirmatory Efficacy guidance as well as the anticipated path forward for publication.
Note: This description assumes that the Confirmatory Efficacy guidance will have been published.
11:00 a.m. – 11:30 a.m. Latest Developments in Disinfectant Claims for Emerging Pathogens
Disinfectant products play a critical role in protecting public health against the increasing number of emerging pathogens; however, due to the unpredictability of emerging pathogens, few disinfectants have been approved against such viruses, thereby limiting the public’s access to effective products. The Centers for Disease Control and Prevention (CDC) will discuss its role and partnerships to ensure that products are available to combat emerging pathogens.
CDC Representative TBD
11:30 a.m. – 12:00 p.m. Update on OECD Quantitative Method
This session will include a presentation on the origins of the OECD Quantitative Disinfection Method, validation history, research on the impact of method parameters on disinfection efficacy, and an update on issues, process, and progress to achieve implementation of the method by regulatory agencies across the globe. Experts will be on hand to answer your questions.
Stephen Tomasino, Ph.D., Microbiology Laboratory, Biological and Economic Analysis Division, EPA Office of Pesticide Programs (OPP) (invited); Industry Speaker TBD
12:00 p.m. – 1:30 p.m. Lunch: Guest Speaker TBD
1:30 p.m. – 2:00 p.m. Update on Legionella Protocol
Legionnaires’ Disease is a potentially deadly form of bacterial pneumonia caused by Legionella pneumophila, which is a waterborne pathogen that can thrive in building water systems and can become pathogenic when aerosolized and inhaled by susceptible individuals. Following several outbreaks of Legionnaires’ Disease in New York, the state promulgated requirements for the regular disinfection of cooling towers using EPA-registered biocides; however, EPA does not have a regulatory path for Legionella claims on biocide products for cooling waters systems. In this session, learn about the collaborative work of EPA and the Center for Biocide Chemistries to address this void and the on-going effort to develop a suitable test method for claims against Legionella in cooling water systems.
Lisa Smith., Microbiology Laboratory, Biological and Economic Analysis Division, EPA Office of Pesticide Programs (OPP (invited)); Industry Speaker TBD
2:00 p.m. – 2:30 p.m. Pursuant of a New Risk-Based Strategy to Ensure Continued Effectiveness of Hospital Disinfectants (APEP)
This session will provide an overview of the recently published Draft Antimicrobial Performance Evaluation Program (APEP). Released in September 2019, the Draft APEP sets forth a risk-based strategy and framework for ensuring the continued effectiveness of Hospital-Level Disinfectants. In particular, this session will address the scope and elements of the APEP, available options for product testing and sample collection, along with a discussion of the plan for communicating the program to stakeholders.
Tajah Blackburn, Senior Scientist for Efficacy Evaluation Team, Antimicrobials Division, EPA Office of Pesticide Programs (OPP)(invited); Industry speaker TBD
2:30 p.m. – 3:15 p.m. Status of States and Antimicrobials
State legislatures and regulatory agencies continue to be active in implementing laws and
regulations that have a significant direct or indirect impact on the manufacture, marketing and
sale of antimicrobial pesticides across the nation. Learn the latest about state activity in the
following areas and how this impacts the sale and distribution of your products:
- Ingredient Disclosure
- FIFRA Section 25b Minimum Risk Pesticides
- Extended Responsibility for Packaging
- Green Cleaning and Procurement
- Chemical Concern Lists
3:15 p.m. – 3:45 p.m. Networking Break
3:45 p.m. – 4:15 p.m. Preservation of Materials
What is a material preservative, why is it needed, and how does a preservative contribute to the sustainability of products? In this session, we will address these questions and many more.
4:15 p.m. – 4:45 p.m. Institutional Customers: Purchasing Preferences
Representatives of key institutional market sectors, including healthcare and education, will discuss their perspective on the disinfectants and sanitizers that they purchase and use to maintain sanitary and healthy conditions for the benefit of those who occupy and visit their facilities. Learn from our panelists about their concerns, issues, and specific needs related to the antimicrobial pesticides that they use as part of their regimen in cleaning and maintaining their facilities for the benefit of the health and well-being of the individuals they serve.
5:00 p.m. – 6:30 p.m. Networking Reception
6:30 p.m. Dinner on Your Own
Day Two—May 13, 2020: Preliminary Agenda
7:30 a.m. – 8:30 a.m. Continental Breakfast
8:30 a.m. – 8:45 a.m. Welcoming Remarks
Moderator Day Two: Abigail Wacek, TSG
8:45 a.m. – 9:30 a.m. Global Outlook on International Trends
Antimicrobial registrants are challenged by different regulatory landscapes from country to country. Public perception and concerns about biocides can also differ region by region. In this session, we will discuss common trends seen with regard to the regulation and use of biocides.
9:30 a.m. – 10:00 a.m. BREXIT: Impact on Registrations
As Britain prepares to leave the European Union, many have speculated how this change in government will significantly impact the regulation of biocides in England. Attendees of this session will learn how Brexit will impact the manufacture, distribution, and marketing of antimicrobial pesticides in Britain, and what ripple effects this might have on the industry generally.
10:00 a.m. – 10:30 a.m. Networking Break
10:30 a.m. – 11:00 a.m. Canada: Treated Articles Policy
The U.S. EPA has a mature treated article policy that has addressed non-public health claims related to articles treated with antimicrobial pesticides for the purpose of preserving the article. Likewise, the Canadian Pest Management Regulatory Agency recently issued its updated policy on treated articles and is working to harmonize its policies with that of the U.S. Attendees will receive an overview of the Canadian treated article policy, and the work that is being done to harmonize the policies of the two neighboring nations.
11:00 a.m. – 11:30 a.m. International Trade Developments and Tariffs on Antimicrobials
The world of international trade has been characterized by volatility and uncertainty in recent Months, wreaking havoc on long standing trade relationships and injecting risk into the equation. This session will address the U.S. tariff wars with China, the new United States-Mexico-Canada Agreement (USMCA), and other international trade developments and how they will impact the global movement of antimicrobial pesticides.
11:30 a.m. – 12:00 p.m. The EPA Safer Choice Program for DfE Pilot for Disinfectants
In addition to the Safer Choice label, EPA offers the Design for the Environment (DfE) recognition for use on disinfectants and sanitizers under its antimicrobial pesticide pilot project. This session will provide the latest information on this unique pilot, including a discussion regarding those antimicrobial products that qualify for DfE recognition, and an update on the status of the program.
12:00 p.m. – 1:30 p.m. Networking Lunch
1:30 p.m. – 2:00 p.m. Update on the Antimicrobial Exposure Assessment Task Force
Established in 2004 by the Center for Biocides Chemistries at the American Chemistry Council, the goal of the Antimicrobial Exposure Assessment Task Force (AEATF II) is to conduct human exposure monitoring studies regarding the mixing, loading, and application of antimicrobial pesticides. Ultimately, these efforts are designed to help meet EPA re-registration and registration review data requirements for antimicrobial actives, and support new active ingredient applications. This session will provide the latest information related to AEATF II activities as well as an overview of how the Agency is using AEATF II data in its regulatory decision process.
2:00 p.m. – 2:30 p.m. Efforts to Reduce Animal Testing
On September 10, 2019, EPA Administrator Andrew Wheeler signed a directive that prioritizes efforts to reduce animal testing. It also directs the Office of Chemical Safety and Pollution Prevention and the Office of Research and Development to prioritize ongoing efforts, and to direct existing resources, toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment. Attend this session, and learn how this recent policy directive is being implemented by the Agency, and what impact it might have on the registration process.
Anna Lowit, Senior Science Advisor, EPA OPP (invited)
2:30 p.m. – 3:00 p.m. Skin Sensitizers
EPA is an active member of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Skin Sensitization Workgroups (SSWG). A key objective of the SSWG is to identify and evaluate non-animal alternative approaches to skin sensitization testing and ultimately gain regulatory acceptance and facilitate use of non-animal approaches. Learn more about ICCVAM’s work and how industry can support these efforts.
Anna Lowit, Senior Science Advisor, EPA OPP (invited)
3:00 p.m. – 3:15 p.m. Discussion and Overview of 13th Antimicrobial Workshop
3:15 p.m. Adjourn