Thirteenth Antimicrobial Virtual Workshop | Agenda


March 24 – April 21, 2021

 SESSION ONE

Wednesday, March 24th, 1 – 3:30 p.m.

State of the Antimicrobial Division & Update on Registration Review

Moderator:  Rhonda Jones, SRC Consulting (Confirmed)

State of the EPA Antimicrobial Division

Anita Pease, Director, Antimicrobials Division, EPA OPP (Confirmed)

Antimicrobial Division Director, Anita Pease, will lead off the Workshop by providing an overview of the Division’s current priorities and activities during these unprecedented times, as well as provide a glimpse into its future directions.  Director Pease will touch upon the Division’s operations and policies in response to the COVID-19 pandemic; future growth of the Division; PRIA and registration review activities; the Antimicrobial Performance Evaluation Program; and Section 810 product performance guidelines.                       

Registration Review of Antimicrobial Products

Rick Fehir, Ph.D., Team Leader and Jose Gayoso, Senior Regulatory Advisor, Antimicrobials Division, EPA OPP (Confirmed)

EPA’s Registration Review program is designed to ensure that pesticides in the marketplace, including antimicrobial pesticides, continue to be used 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 its efforts to meet the October 2022 deadline.  EPA will discuss the importance of registrant participation and optimal ways for the public to weigh in to this process.

Emerging Efficacy Trends

Moderator:  Rhonda Jones, SRC Consulting (Confirmed)

Residual and “Long Lasting” Claims of Efficacy—EPA Interim Guidance  

Speaker: Nicole Karikari, Biologist, Efficacy Branch, Antimicrobials Division, EPA OPP (Confirmed)

In October 2020, the EPA released interim guidance that establishes testing procedures and an expedited pathway for disinfectant product claims of residual or long-lasting effectiveness on surfaces against viruses like SARS-COV-2, the coronavirus that causes COVID-19. This session will provide an overview of the guidance development and well as any changes made based in response to public comments.


 SESSION TWO – Wednesday, March 31st, 1 – 3:30 p.m.

The Impact of COVID-19 on Public Policy and Industry Supply Chains

Moderator:  Abigail Wacek, TSG Consulting (Invited)

CDC Policies on Emerging Pathogens, COVID-19

Speaker: TBD

The Centers for Disease Control and Prevention (CDC) has been at the forefront during the COVID-19 pandemic with general guidance impacting disinfectants, hand sanitizers, reopening of public facilities, returning to the workplace and other critical aspects of our nation’s efforts in combatting the pandemic.  CDC officials will discuss its role, policies and ongoing efforts to ensure the public’s health and safety in light of the COVID-19 pandemic and future emerging pathogens.    

COVID-19 Emergency Policies:  EPA and Disinfectants

Speaker: John Hebert, Chief, Regulatory Management Branch I, Antimicrobials Division, EPA OPP (Confirmed)

To ensure a ready supply of disinfectants and hand sanitizers effective against the SARS-COV-2 virus, EPA provided flexibilities on many policies to reduce the barriers to entering the marketplace while still ensuring safety for such important products. EPA officials will discuss the implementation and impact of these policies and lessons learned.

Supply Chain Issues and Solutions

Speakers: Howard Bochnek, VP—Technology  and Scientific Affairs, North American Infection Control Ltd., and American Infection Control, Inc.; and Ernesto Lippert, VP of Strategic Development & Advocacy, Lonza

Companies faced unprecedented stress on its manufacturing of disinfectant, sanitizing and cleaning products during the COVID-19 crisis. Speakers will discuss responses to these stresses, including the response from the supply chain and the long-term impacts.

Electrostatic Sprayer Guidance

Speaker: Timothy Leighton, Senior Science Advisor, Risk Assessment Branch I, Antimicrobials Division, EPA OPP (Confirmed)

In July 2020, the EPA announced its guidance for expediting review for products to add electrostatic sprayers to product labels. The guidance provides several different scenarios for companies to follow to add this application method to labels. This session will delve into the development of the guidance as well as any anticipated thoughts for the guidance in the future.


 SESSION THREE – Wednesday, April 7th, 1 – 3:30 p.m.

Updates: OECD Quantitative Method, Legionella Protocol, APEP, TTC

Moderator:  Rhonda Jones, SRC Consulting (Confirmed)                                              

OECD Quantitative Method

Kimberly Nesci, Acting Director, Biological and Economic Analysis Division, EPA OPP (Confirmed)

Stephen Tomasino, Ph.D.,Microbiology Laboratory, Biological and Economic Analysis Division, EPA OPP (Confirmed)

Pat Quinn, The Accord Group (Invited)

 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.

Legionella Protocol               

Lisa Smith.,Microbiology Laboratory, Biological and Economic Analysis Division, EPA OPP (Confirmed)

Elaine Black, Ecolab (Invited)

 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.

Antimicrobial Performance Evaluation Program

Tajah Blackburn, Senior Scientist for Efficacy Evaluation Team, Antimicrobials Division, EPA OPP (Confirmed)

Diane Boesenberg, Exponent (Invited)

This session will provide an overview of the 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.  

Reducing Animal Testing

Anna Lowit, Senior Science Advisor, EPA OPP (Confirmed)

Seth Goldberg, Steptoe and Johnson (Invited)

 EPA continues its work in reducing animal testing.  Administrator Andrew Wheeler has directed the Office of Chemical Safety and Pollution Prevention and the Office of Research and Development to prioritize ongoing efforts to reduce animal testing, 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 policy directive is being implemented by the Agency, and what impact it is likely to have on the registration process.


 SESSION FOUR – Wednesday, April 14th, 1 – 3:30 p.m.

Global Outlook: International Trends, BREXIT, & International Trade Developments and Tariffs on Antimicrobials

Moderator: Abigail Wacek, TSG Consulting (Invited)

International Trends

Robert Kiefer, General Manager, REACH24H USA Inc.

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.

BREXIT

Darren Abrahams, Steptoe and Johnson (Confirmed)

The exit of Britain from the European Union significantly impacts the regulation of biocides in England.  Attendees of this session will learn how Brexit impacts the manufacture, distribution, and marketing of antimicrobial pesticides in Britain, and the ripple effects this has on the industry generally.

International Trade Developments and Tariffs on Antimicrobials

Ben Dunham, Dunham Law & Policy PLLC (Invited)

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 developments and how they will impact the global movement of antimicrobial pesticides.

Treated Articles Policy in Canada, U.S. and the EU

Dana Chaulk, Pest Management Regulatory Agency, Health Canada (Invited)

Michael Downs, Pest Management Regulatory Agency, Health Canada (Invited)

Seth Goldberg, Steptoe and Johnson (Invited)

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.

Preservation of Materials

Lynn Tordo, Thor Corporation (Invited)

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.


SESSION FIVE – Wednesday, April 21st, 1 – 3:30 p.m.  

Moderator:  Abigail Wacek, TSG Consulting (Invited)

The EPA Safer Choice Program for DfE for Disinfectants

Clive Davies, Lead, Safer Choice and Design for the Environment Programs, EPA (Confirmed)

In addition to the Safer Choice label, EPA offers the Design for the Environment (DfE)

Certification for use on disinfectants and sanitizers. This session will provide the latest information on this unique program, including a discussion regarding those antimicrobial products that qualify for DfE certification, and an update on the status of the program.

Green Seal’s Proposed Standard for Hand Sanitizers

Doug Gatlin, CEO, Green Seal (Confirmed)

Green Seal’s hand sanitizer standard and certification program provides purchasers and consumers a simple way to choose safer and effective products. Hand sanitizers are critical to public health worldwide as governments and healthcare groups work to slow the spread of COVID-19. However, hand sanitizers available on the US market can be formulated with hazardous ingredients linked to cancer, allergies, skin and eye irritation, and other harmful health effects. In addition, with sudden demand spurring many first-time producers to enter the market, the U.S. Food and Drug Administration has warned consumers to beware of incorrectly formulated hand sanitizers that contain high levels of hazardous ingredients.

Update on the Antimicrobial Exposure Assessment Task Force

Has Shah, AEATF II (Confirmed)

*Leah Rosenheck, LR Risk Consulting (Invited)

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.

Skin Sensitizers

Anna Lowit, Senior Science Advisor, EPA OPP (Confirmed)

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.