For Release: April 7, 2016

The U.S. Environmental Protection Agency has updated the emerging pathogens guidance for the claims that can be made for EPA-registered disinfectant products intended to combat emerging viral pathogens. This document provides general guidance on a viral hierarchy that can be used to identify effective disinfectant products for use against emerging pathogens and permit registrants to make limited claims of their product’s efficacy against such pathogens. The revisions to the guidance are intended to expedite the process for registrants to provide useful information to the public on effective products.

Emerging pathogens are increasingly a public health concern.  Many of the pathogens of greatest concern are viruses, and the ability of some of these viruses to contaminate hard surfaces can play a role in the transmission of these viruses to people. Under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. Few if any EPA-registered disinfectant product labels specify use against emerging pathogens, and the pathogens themselves are often commercially unavailable for testing. 

To address this need, EPA is providing a voluntary, two-stage process involving product label amendments and modified terms of registration (described in this guidance), through which registrants may, during a human or animal disease outbreak, identify existing registered disinfectant products that are expected to be efficacious against the specific emerging viral pathogen. This guidance applies only to emerging viruses, and actions described by this guidance may be taken for eligible products only after the Centers for Disease Control and Prevention has identified the emerging pathogen and recommended environmental surface disinfection to help control its spread.

Comments related to clarity of this guidance document were accepted until May 6, 2016.  To review the draft guidance and provide comments, go to docket EPA-HQ-OPP-2016-0144 at www.regulations.gov.

Note: the revised guidance based on those comments was released in September 2016.