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Details

Greening Operation Series: Regulatory update – Antimicrobial Labeling Update from the EPA

Jul 30 2009 – 01:00 PM Eastern

This webinar will last approximately 90 minutes.

Topic

The Environmental Protection Agency said June 12 that approximately
one-third of 325 registered hospital disinfectants and 36 of the 72
tuberculocides tested thus far under the Antimicrobial Testing Program
(ATP) failed to meet its standards for effectiveness against bacteria.
Products failing the tests “are brought into compliance through
regulatory or enforcement measures, or a combination of both,” EPA said.

EPA has already ordered changes to the antimicrobial claims on some
product labels and is reviewing others, according to a table of test
results and other information published on the agency’s antimicrobial
testing website June 12. The reviews could result in requiring
registrants to reformulate their products, reduce their product claims,
change their use directions, or cancel the products, EPA said.
Products Could be Recalled

Representative of the Antimicrobial Division of the EPA Office of
Pesticides Programs will discuss the implication of this report, and
answer questions from the health care community.

EPA’s Office of Pesticide Programs (OPP) has the responsibility under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to regulate the registration of antimicrobial products used to control pathogenic bacteria, viruses and other microorganisms for a variety of uses. Under FIFRA, the registrant of a product with a public health claim is required to submit efficacy, or effectiveness, data to EPA in support of the product’s registration. EPA reviews the effectiveness data as part of the registration process for each product. If the data meet efficacy standards and all other requirements for registration are met, the product qualifies for registration and is issued a distinct identification number, or EPA registration number, that appears on the product’s label along with other required statements.

Objectives

  • How EPA Regulates Antimicrobials
  • How EPA Ensures Product Efficacy for Hospital Disinfectants

*Overview of EPA’s Antimicrobials Testing Program

*Availability of information on the Antimicrobial Program

*AD’s Hospital Community Outreach Initiative

Presenters

  • Joan Harrigan-Farrelly, EPA, Office of Pesticide Programs

    Email: harrigan-farrelly.joan@epa.gov   Telephone: 703-308-6411

    Joan Harrigan-Farrelly has been with the U.S. Environmental Protection Agency for over 10 years and has had the unique opportunity to work in various leadership positions across the Agency. Joan has served as the Director, Resources Management Division in the Superfund Program; as Branch Chief in the Office of Ground Water and Drinking Water; and as Senior Advisor in EPA’s Office of Homeland Security. Prior to her service with the U.S. EPA, Joan also worked with USAID as a Senior Fellow in the Policy Bureau; and as Director, Coastal Zone Management Program in the United States Virgin Islands.

    In her current position as the Director of the Antimicrobials Division in the Office of Pesticide Programs (OPP) at the U.S. EPA, Joan is responsible for all regulatory activities and science analysis associated with antimicrobial pesticides, including new chemical and product-specific registrations, registration review, efficacy analysis for public health products, and environmental fate and human health analysis.

    Joan’s vision is to ensure seamless coordination with all regulatory and science partners so that the highest level of efficiency is achieved as AD ensures the use of the best science in its mission to protect human health and the environment in its registration and re-evaluation of chemicals used against microbiological pests.

    Joan holds a Bachelors degree from Rutgers University and a Masters degree from New York University.

  • Tajah Blackburn, Ph.D., EPA, Microbiologist

    Email: blackburn.tajah@epa.gov   Telephone: (703) 308-0372

    Tajah Blackburn, PhD. is a Microbiologist with the Environmental Protection Agency (EPA), while serving the community as Lieutenant Commander in the Public Health Service. In her role with the Agency, Dr. Blackburn is responsible for reviewing product efficacy data, assisting stakeholders with science guidance questions, and providing scientific guidance in response to emerging public health concerns.

  • Dennis Edwards, EPA, Antimicrobials Division

    Email: Edwards.Dennis@epamail.epa.gov   Telephone: 703-308-8087

    Dennis Edwards has worked at EPA for over 30 years. He has been Branch Chief of Regulatory Management Branch 1 in the Antimicrobials Division since its creation by the Food Quality Protection Act (FQPA) amendment to FIFRA in 1996. Prior to coming to the Antimicrobials Division, he was Product Manager of a PM Team in the Registration Division/Insecticide Rodenticide Branch for 10 years. Mr Edwards has a BS degree and a MS degree from Clemson University.

  • Ben Chambliss, EPA, Antimicrobials Division

    Email: Chambliss.Ben@epamail.epa.gov   Telephone:

    Ben Chambliss currently works as a Biologist in the Antimicrobials
    Division of the Office of Pesticide Programs. He has a Masters of
    Science Degree in Environmental Biology (Ohio State University Class of
    1980). He has twenty years experience with the Environmental Protection
    Agency working primarily in the areas of pesticide registration and
    pesticide reregistration.


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