EPA Releases Significantly Expanded List of Registered Disinfectants Available for Use Against Novel Coronavirus SARS-CoV-2

The spread of the coronavirus SARS-CoV-2 has reached pandemic proportions. According to the Johns Hopkins Virus Tracker, as of this writing on March 17, there have been over 196,000 cases and over 7,800 deaths worldwide.  Spread across the U.S. is rapidly evolving, with more than 5,700 reported cases and 100 deaths.

In further response to these developments, on March 13, 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 caronavirus SARS-CoV-2, the novel caronavirus that causes COVID-19. See EPA List of Disinfectants for Control of SARS-CoV-2

The products identified by EPA all established through the Emerging Viral Pathogen Program their efficacy against the COVID-19 caronavirus.  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.  EPA recently announced that the process is available to permit claims for the control of  COVID-19. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2

Listed disinfectant registrants must have labels which already identify a specific emerging pathogen as a target organism.  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.

One critical aspect of disinfect use is often overlooked by users. All products list minimum contact times, meaning the length of time that surface be treated must remain wet. The majority of products require a ten minute contact time, and a significant number require five minutes. There are a limited number products that have one or two minute periods, and a few as short as thirty seconds. Failure to maintain wetness for the required period means the product will not achieve control, in this case of the virus.  Recent news images of hard surfaces being treated do not instill confidence, as in many cases it is obvious the minimum contact time is not being maintained.  

EPA Releases Updated List of Registered Disinfectants Available for Use Against Novel Coronavirus SARS-CoV-2

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 caronavirus 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. 

EPA Responds to Coronavirus; Reminds Registrants of Ability to Add Coronavirus to Disinfectant Product Target Pests on Expedited Basis

In response to the spreading coronavirus epidemic, the U.S. Environmental Protection Agency (“EPA”) issued a reminder to the registrant community that an expedited process is available to add the 2019-nCoV coronavirus as a target pest on appropriate hard surface disinfectant products. 

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 has now announced that the process is available to add the 2019-nCoV virus as a target pest.

In order to take advantage of this option, a disinfectant registrant must have first pursued a formal amendment adding a specific emerging pathogen to its label. Once so positioned, the registrant may communicate through off-label channels that the product may be used for a similar, previously unidentified emerging pathogen. Coronaviruses are enveloped viruses, which are among the more easily viruses controlled on hard surfaces. To utilize this mechanism in this instance registrants must have previously added a different enveloped virus to the 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 2019-nCoV. See Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV)

Once qualified, registrants are allowed to communicate to target users the ability to employ their disinfectants for the control of 2019-nCoV. 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. 

EPA Webinar seeking input on developing product testing strategies on Hospital Disinfectants

The EPA plans to host a webinar June 21st between 1-3 p.m. ET to focus on the effectiveness of disinfecting agents in hospitals. The EPA is seeking input from registrants of antimicrobial products and laboratory personnel with efficacy testing responsibilities. Additional details on the webinar can be found here. To register for the webinar, you can follow this link.

After the webinar, the docket EPA-HQ-OPP-2018-0265 at www.regulations.gov will be open for comments.

 

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