US EPA announces draft guidance on expedited Section 3 registration for “long-lasting” disinfecting products
The US Environmental Protection Agency (EPA) released a draft guidance for the expedited registration of “long-lasting” disinfecting products. This move allows for consumers to have increased access to products that provide residual disinfection against SARS-CoV-2, the virus that causes COVID-19.
“EPA is providing an expedited path for our nation’s manufacturers and innovators to get cutting-edge, “long-lasting” disinfecting products into the marketplace as safely and quickly as possible,” said EPA Administrator Andrew Wheeler.
The guidance identifies specific testing requirements for supplemental residual antimicrobial products and residual disinfectants. Residual disinfectants are eligible to be added to List N: Disinfectants for use Against SARS-CoV-2 (COVID-19), while the supplemental products are not eligible for List N inclusion, they will be added to a separate List N appendix.
The draft guidance is in immediate effect for these residual efficacy products and may be revised after the 60-day public comment period.
EPA has also released an updated testing protocol for evaluating the efficacy of copper surfaces against bacteria, as well as draft protocol for testing the efficacy of antimicrobial surface coatings.
How TSG can help
TSG's consultants can assist with data development and review, drafting product label and claims, and assembling submission packages to comply with EPA’s draft guidance.