By Matthew G. Lawson
On January 29, 2020, the United States Environmental Protection Agency (“USEPA”) activated its Emerging Viral Pathogens Guidance for Antimicrobial Pesticides (the “Guidance”) in an attempt to help curb the spread of the Novel coronavirus (2019-nCoV) (the “Coronavirus”) in the United States. Drafted pursuant to USEPA’s authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Guidance sets forth a voluntary process by which companies holding FIFRA registrations for disinfecting/antimicrobial products can promote the use of their products against specific “emerging pathogens,” including the Coronavirus. While the Guidance was finalized in August 2016, it had remained inactive prior to USEPA’s recent announcement.
Under the typical FIFRA registration process, the manufacturer of a disinfecting product that wishes to promote the product’s use against a specific virus or bacteria must first submit testing data to USEPA that demonstrates the product’s efficacy against the microbe. Following USEPA’s approval of the submitted data, the manufacturer is then permitted to update its product’s labeling to include the use of the product against the microbe. However, as noted by USEPA, “
ecause the occurrence of emerging viral pathogens is less common and predictable than established pathogens,” it can be difficult “to assess the efficacy of EPA registered disinfectants against such pathogens in a timely manner and to add these viruses to existing product registrations…” For this reason, USEPA’s emergency Guidance allows manufacturers to receive special permission to advertise their products for use against emerging viral pathogens during public health outbreaks. The intent of USEPA’s guidance is to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging pathogens.
To receive the benefit of the Guidance, a manufacturer must submit a “label amendment request” to USEPA with a statement explaining its product’s effectiveness against an emerging viral pathogen. This step is ideally completed prior to a public health outbreak. So long as the product meets certain eligibility criteria, USEPA will approve the amendment. Next, in the event a public health outbreak occurs and the Centers for Disease Control and Prevention (“CDC”) “identifie[s] [an] emerging pathogen and recommend[s] environmental surface disinfection to help control its spread,” approved manufacturers are permitted to start advertising the effectiveness of their products for controlling the pathogen. A manufacturer can provide a statement of their product’s efficacy against the 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.” However, the efficacy statement may not appear on the actual label of the product.
As of Tuesday, February 4, 2020, more than 20,500 cases of the coronavirus have been confirmed worldwide. While the vast majority of confirmed cases have occurred in mainland China, cases have been confirmed in more than two dozen other countries, including eleven confirmed cases in the United States. The CDC has warned that the Coronavirus poses an “unprecedented threat” to public health in the United States. USEPA’s Guidance notes that the agency will continue working closely with the CDC to identify and address Coronavirus in a timely manner and to monitor developments closely.