Coronavirus Activates EPA Emerging Pathogens Rapid Response

In response to coronavirus cases now appearing in the U.S., yesterday, EPA announced that the agency has activated its Emerging Viral Pathogens Guidance for Antimicrobial Pesticides (a copy of which can be found here).

The voluntary guidance, issued in August 2016, details a process by which companies holding current EPA registrations under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) for certain disinfectant products can promote those products for use against "emerging pathogens," like the coronavirus.

Typically, to be registered for use against a specific bacteria or virus, disinfecting/antimicrobial products must submit to EPA test data showing that the product is effective against that particular microbe. EPA's "emerging pathogens" policy was established to allow for the legal "off-label" use of disinfectants against a novel virus for which no product would as yet have EPA approval and for which test data and methods likely do not exist.

Many of the emerging pathogens of greatest concern are pathogenic viruses, and the ability of some of these viruses to persist on environmental surfaces can play a role in human disease transmission.

- EPA Office of Pesticide Programs, "Update: Coronavirus Cases Trigger EPA Rapid Response" (Jan. 29, 2020)

The good news? According to EPA, "coronaviruses are enveloped viruses, meaning they are one of the easiest to kill with the appropriate disinfectant product."

The guidance establishes a two-step process by which existing registrants first submit a request to EPA for a label amendment adding to their registration a statement of effectiveness against emerging viral pathogens. This may (and, ideally, should) be done prior to an outbreak. If the product meets the eligibility criteria, the agency generally will approve the amendment. Then, in the second stage of the process, when an outbreak of an emerging pathogen occurs, registrants of products with the "emerging pathogen" label amendment may then communicate to the health care community and public that their product may be used against the newly emerged pathogen.

Registrants with such a "pre-qualified emerging viral pathogen designation" can include a statement regarding efficacy against an emerging pathogen "in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites."

EPA's emerging pathogens guidance is only triggered after the Centers for Disease Control and Prevention (CDC) "has identified the emerging pathogen and recommended environmental surface disinfection to help control its spread." EPA implements the policy in close coordination with the CDC and reportedly the two agencies are closely monitoring developments with the coronavirus: "Based on what we know right now, the immediate risk to America is low."

More information on the coronavirus is available from the CDC.

Tags: Coronavirus