The US Environmental Protection Agency (EPA) recently released a new list of disinfectants that can be used against the virus that causes the coronavirus (COVID-19) disease. All of these disinfectant products qualified for a streamlined pesticide approval process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) through the agency’s Emerging Viral Pathogen program. Importantly this list only covers surface disinfectants, and hand sanitizers are not included; these products are instead regulated by the US Food and Drug Administration (FDA).
COVID-19 triggered the Emerging Viral Pathogen guidance on January 29, 2020, and, currently, EPA is expediting registration submissions only for claims for surface disinfectants that have already been registered with EPA and which will not require the agency to review new efficacy data. EPA is accepting these submissions as non-PRIA (Pesticide Registration Improvement Act) fast-track amendments.
Products approved under the expedited Emerging Viral Pathogen program must still comply with FIFRA, and all pesticide products must still be properly labeled and registered with EPA. The agency classifies essentially any disinfectant that can be used to kill microorganisms as an antimicrobial pesticide regulated under FIFRA.
FIFRA regulates the use and sale of pesticide products, and requires that all pesticides must be registered with EPA prior to sale or distribution in the United States. 7 USC §§136 et seq. EPA has authority to grant conditional registrations—which are temporary—if it decides that use of a pesticide product is in the public interest. Generally, in order to register a product, applicants must provide EPA with data related to the product’s impacts on the environment, health and safety. Importantly, applicants must show that the product will not cause “unreasonable adverse effects on the environment,” (7 USC§ 136a(c)(5)) which are defined under FIFRA as “(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of Title 21.” 7 USCA § 136(bb).
The Emerging Viral Pathogens program is a two-step process that allows applicants to make some claims with respect to their product’s effectiveness against pathogens that have been deemed emerging pathogens by the Centers for Disease Control and Prevention (CDC), and for which the CDC has identified surface disinfection as a potential method to control spread. EPA initially began this expedited program because these new pathogens tend to be unpredictable and because, at the beginning of an outbreak, almost no disinfectants registered with EPA will already be approved for use against these new pathogens. This expedited process is particularly helpful in addressing emerging viral pathogens, as standards for laboratory testing often do not exist at the beginning of a new outbreak.
The use of appropriate pesticide products can help to reduce spread of COVID-19, as coronaviruses are enveloped viruses, and are thus particularly susceptible to disinfectants. According to the CDC, COVID-19 might be able to live for up to hours or even days on surfaces, although the CDC has yet to document transmission of the virus via contaminated surfaces.
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