History
The Environmental Protection Agency (EPA) has confirmed that the 2019 novel coronavirus-Wuhan (also 2019-nCoV) has met the conditions outlined in EPA’s emerging viral pathogens guidance and has triggered the emerging viral pathogen policy.
Action taken by Decon7 Systems, LLC
The Wuhan Coronavirus is an enveloped virus. D7 Part 1 & Part 2 has a small enveloped virus claim (Norovirus) and is therefore eligible to submit a label amendment to add emerging pathogen language for enveloped and large, non-enveloped viruses. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended by the Food Quality Protection Act of 1996 (FQPA) requires the EPA to develop procedures and guidelines for expedited review of any pesticide. In February 2020 Decon7 Systems, LLC filed its FQPA Fast-track submission to the EPA for a label amendment to include claims against COVID-19. Once Decon7 receives its approval notice from the EPA that it has the Emerging Pathogen claims on the master label, it will be placed on the N list.
EPA Approval
On March 23, 2020, the EPA forwarded a letter to Decon7 Systems, LLC indicating that our Label Amendment was approved to include claims against COVID-19. COVID-19 is the name of the emerging virus. D7 Part 1 and Part 2 has a small enveloped virus claim, Norovirus, on its current labels. Norovirus is the name of the supporting virus.
On page 8 of the letter from the EPA there is a section entitled “Emerging Viral Pathogens”. Under that section there is language that Decon7 is permitted to use on its labeling. There are brackets left blank with instructions to insert the appropriate language. It reads as follows:
“[Product name=D7] has demonstrated effectiveness against viruses similar to [name of emerging virus=Coronavirus or COVID-19] on hard, non-porous surfaces. Therefore, [Product name=D7] can be used against [name of emerging virus=COVID-19] when used in accordance with the directions for use against [name of supporting virus=Norovirus] on hard, non-porous surfaces. Refer to the [CDC or OIE] website at [pathogen-specific website address] for additional information.”
{OR}
“[Name of illness or outbreak=Coronavirus] is caused by [name of emerging virus=COVID-19]. [Product name=D7] kills similar viruses and therefore can be used against [name of merging virus=COVID-19] when used in accordance with the directions for use against [name of supporting virus=Norovirus] on hard, non-porous surfaces. Refer to the CDC or OIE website at (website address) for additional information.”
