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EPA publishes long-awaited FAQ for Series 810 Guidelines related to antimicrobial product performance efficacy tests

September 05, 2019

The U.S. Environmental Protection Agency (EPA) has recently published the long-awaited Frequently Asked Questions web resource (FAQ) for the Series 810 antimicrobial product performance test guidelines. The revised test guideline series 810.2000, 810.2100 and 810.2200 address the general considerations and specific testing requirements to support sterilant, sporicide, and disinfectant product public health claims. The guidelines had an original February 28, 2018 implementation date; however due to stakeholder confusion around the revised test and performance requirements, EPA postponed implementation to August 28, 2019. The delay also enabled EPA to publish FAQ’s to accompany the guidelines to provide clarifications. EPA developed the resource to “provide prompt and transparent guidance to all applicants regarding commonly asked questions concerning the [updated] 810 guidelines.”

All studies initiated (date the study director signs the protocol) on or after August 28, 2019 must comply with the procedures, methods, and performance criteria outlined in the revised guidance to support antimicrobial pesticides bearing applicable public health claims. Per EPA guidance, studies that were initiated before the implementation date may use either the previous version of the guidelines (2012) or the revised (2018) versions, as appropriate.

EPA’s FAQ web resource provides some additional guidance to help navigate the complexities of antimicrobial pesticide efficacy testing to support public health products. When confusion remains, TSG’s team of experienced regulatory consultants is here to help guide you to successful product registration.

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