EPA Announces Approval of First-Ever Long-Lasting Antiviral Product for Use against COVID-19
On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days. EPA states that after carefully reviewing the available data and information, it “determined that the product helps to address the current national emergency.” According to EPA, the product is “expected to provide longer-lasting protection in public spaces, increasing consumer confidence in resuming normal air travel and other activities.”
FIFRA Section 18 authorizes EPA to exempt federal or state agencies from any provision of FIFRA in the event that emergency conditions require such an exemption. EPA regulations (40 C.F.R. Part 166) specify when state or federal government agencies will be permitted to use unregistered pesticides in response to an emergency. EPA’s regulations provide that an emergency exists when:
- There is an “urgent, non-routine” situation requiring the use of a pesticide to control a new pest not previously prevalent in the United States, to control significant risks to health, the environment, beneficial organisms, or endangered species, or to prevent specified types of economic loss; and
- There is no registered pesticide or economically or environmentally feasible alternate method of control available.
40 C.F.R. § 166.3.
The exemptions granted can be very specific and time-limited; EPA has developed a database so companies can search (by chemical, site, pest, applicant, or date range) to determine if an emergency exemption has been issued and its expiration date.
In this case, EPA approved the Section 18 emergency exemption request for SurfaceWise2 -- a product manufactured by Allied BioScience -- a surface coating that Allied BioScience states inactivates viruses and bacteria within two hours of application and continues to work against them for up to seven days, between regular cleanings. EPA’s approval will allow Texas to permit American Airlines airport facilities and planes at specific locations and two Total Orthopedics Sports & Spine Clinics to use SurfaceWise2 under certain conditions. The approved Section 18 emergency requests are effective for one year. As new data emerge, EPA may alter the terms of the product’s emergency uses.
Over the coming months, Allied BioScience will pursue a non-emergency approval under FIFRA Section 3 by submitting additional data to meet EPA’s registration requirements as an antiviral and antibacterial surface coating. If the full registration process is completed, the product would become available for purchase by members of the public. SurfaceWise2 is not yet available to the general public because Allied Biosciences has not yet submitted the necessary data to qualify for registration under Section 3 of FIFRA.