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.
EPA states that it has not received any other Section 18 applications for products with residual efficacy against coronaviruses like SARS-CoV-2, but that is likely to change following this approval and ongoing activities by companies seeking options for products to use against SARS-CoV-2. EPA states it will consider any such requests submitted related to the COVID-19 public health emergency, and also anticipates posting information for companies or individuals who are interested in pursuing a FIFRA Section 3 registration for antiviral surface coatings in the coming weeks.
States or federal agencies interested in pursuing a Section 18 emergency exemption request for products that claim residual efficacy against viruses should be prepared to include efficacy data demonstrating that the product is durable and effective against viruses for up to the periods of time after application. It will be essential to ensure that these data will be deemed sufficient by EPA to determine efficacy and durability, which may require discussion with EPA. EPA will review the results of these studies to ensure that surface coatings remain effective under the anticipated proposed conditions of use.
Additional information on Section 18 emergency exemption requests and Sars-CoV-2 is available here.