On October 14, the Environmental Protection Agency (EPA) issued new interim guidance to expedite approvals that would allow companies to make claims regarding the residual effectiveness of long-lasting surface disinfectants and other products against COVID-19. In response to the constant need to disinfect public spaces, companies have been developing innovative products that do not require continuous application. The process recently announced by the Agency is intended to fast-track products to market that are capable of keeping surfaces clean for several hours or even days.
EPA regulates the distribution, sale, and use of products that are intended to prevent or destroy pests (for example, alcohol surface wipes) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). All retail-ready pesticide products must be registered and approved by EPA, but there are options for expediting approval when there is a new viral pathogen. During a product’s evaluation process, the registrant develops a product label with detailed information, identifying the specific pest that the product may be used to target and the conditions under which it may be used. When a new pest is identified, registrants may not make any claims about the product until a new evaluation is conducted and a new label approved, even if the product may be effective against the new pest. In response to the potential for novel pandemics, in 2016 EPA initiated a voluntary, two-stage process to enable the use of certain registered disinfectant products against emerging viral pathogens not identified on the product label. In recognition of the need to get disinfectant products on the market quickly, EPA released a list (known as List N) of registered disinfectant products that have qualified for use against the SARS-CoV-2 pathogen, which causes COVID-19.
On August 24, EPA issued an emergency exemption to the state of Texas, permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that kills coronaviruses (like the SARS-CoV-2 virus) on surfaces for up to seven days. After reviewing the available data and information, the Agency allowed the product to add long-lasting claims to its registration.
EPA’s updated guidance is intended to provide a broader avenue for companies developing long-lasting disinfectants and anti-microbial products to make such claims without utilizing an emergency exemption. The most recent guidance provides a roadmap that allows companies to register products that are already known to be effective against coronavirus and have the “residual” ability to keep surfaces disinfected long after use — including approved List N-products, potential List N products, or products that can be used as a residual supplement to disinfectants on List N. The guidance outlines two categories of products:
(1) disinfectants that also provide residual efficacy for hours or days, and
(2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that are not a replacement for conventional cleaning products.
The guidance describes the type of scientific data EPA needs for each product category so that the Agency can quickly process applications. The amount of scientific data, the level of EPA process, and the expected approval timing is based on whether a product’s particular combination of chemicals has been previously registered with the Agency and whether the new long-lasting product is an amendment to an already approved formulation or an entirely new formula.