The guidance, issued in 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 guidance establishes a two-step process.
First, registrants 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, detailed in the guidance document, the agency generally will approve the amendment.
The second stage of the process, when an outbreak of an emerging pathogen occurs, such as what we are seeing with the novel coronavirus, SARS-CoV-2, 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 work closely with the EPA to ensure that they are following the guidance and avoid potential citations.
Registrants with 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.”
If you have questions about your favorite disinfectant, refer to the manufacturer’s website to see if it has the emerging pathogens claim for the novel coronavirus, SARS-CoV-2.
But what about for the rest of the world?
Each country will have their own requirement for disinfectant claims for SARS-CoV-2. It is important to review the requirements and approvals in your country.
Refer to ISSA/GBAC Tip Sheet 2 - Recommendations for RISK ASSESSMENT for the cleaning and forensic restoration industry, when preparing to clean, sanitize, and disinfect spaces.
Below are links to sites with more information on SARS-CoV-2, including, ISSA, WHO, CDC, EPA, and www.InfectionControl.tips:
Previous Tip Sheets:
View the GBAC Tip Sheet on using personal protective equipment here.
View the GBAC Tip Sheet on risk assessment here.