When developing a disinfectant or sanitizer (herein referred to as disinfectant) for use on environmental surfaces, the Sponsor must first develop and support a label claim based on guidelines set forth by the United States Environmental Protection Agency (EPA). To substantiate the label claim, the Sponsor must perform one or more evaluations as dictated by the EPA.
This presentation aims to provide a general overview of disinfectant efficacy testing and offer a detailed methodology to assist in designing studies for submission to the EPA that accurately represent facility procedures and ensure compliance with the Office of Chemical Safety and Pollution Prevention (OCSPP) guidance.
The session will begin by explaining the principles and objectives behind disinfectant efficacy testing, including the regulatory requirements set by the EPA. Understanding these fundamentals is crucial for developing a compliant and effective disinfectant product. The presentation will then guide attendees through the process of designing efficacy studies that accurately reflect the procedures used in the sponsor’s facility. This includes selecting appropriate test methods and ensuring they align with EPA guidelines.
Next, the presentation will delve into the various testing methodologies and strategies that can be employed to evaluate disinfectant efficacy. Attendees will learn about different test methods, their acceptance criteria, and how to interpret the results. This comprehensive approach ensures that all aspects of disinfectant efficacy are thoroughly evaluated.
Finally, the session will cover how to gather, interpret, and present the results of a disinfectant efficacy evaluation for submission to the EPA. Best practices for documenting and reporting findings will be discussed, ensuring that the sponsor’s label claims are well-supported and meet regulatory expectations.
By attending this presentation, sponsors and professionals involved in the development and regulatory submission of disinfectants will gain valuable insights into the EPA’s requirements and how to effectively design and conduct efficacy studies. This knowledge is essential for ensuring that disinfectant products are safe, effective, and compliant with regulatory standards.