The coronavirus SARS-CoV-2 epidemic continues to spread across the globe. According to the Johns Hopkins Virus Tracker, as of this writing on March 9, there have been over 111,000 cases and almost 3900 deaths worldwide. Spread across the U.S. is rapidly evolving, with 566 reported cases and 22 deaths.
In further response to these developments, on March 5, 2020, the U.S. Environmental Protection Agency (“EPA”) issued an updated list of registered disinfectants available for use on hard surfaces for the control of the novel coronavirus SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA List of Registered Disinfectants Authorized to Claim Control of Novel Coronavirus.
The eighty-five products identified by EPA all established through the Emerging Viral Pathogen Program their efficacy against the COVID-19 coronavirus. Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label. On August 19, 2016 EPA issued a guidance document entitled Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels. (“Guidance”). The Guidance outlines a two-stage process for disinfectant registrants to position themselves so that emerging viral pathogens can be identified as target pests without having to pursue a formal label amendment or supply efficacy data on the specific emerging pathogen. EPA recently announced that the process is available to permit claims for the control of COVID-19. See Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV).
In order to take advantage of this option, disinfectant registrants must have first pursued a formal amendment adding a specific emerging pathogen to its label. To qualify for being promoted for a new emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question, and that the virus presents a survival risk on hard surfaces. CDC has done so for COVID-19. According to EPA, each of these products has demonstrated efficacy against an enveloped virus as least as difficult to control as Coronavirus SARS-CoV-2.
Registrants of the identified products are allowed to communicate to target users the ability to employ their disinfectants for the control of COVID-19. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment.