EPA Settlement with Allied BioScience Addresses Alleged Claims of SurfaceWise2 Product and SARS-CoV-2 Viruses
DALLAS – (March 10, 2022) The U.S. Environmental Protection Agency (EPA) settled with Allied BioScience, Inc. (Allied BioScience) over alleged violations of federal pesticide regulations with the company’s SurfaceWise2 product, a residual antimicrobial surface coating. EPA investigations found the company was marketing, selling, and distributing SurfaceWise2 in ways that were inconsistent with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA’s regulations, and the terms and conditions of its emergency exemption authorizations, specifically with regard to the product’s claims about SARS-CoV-2 viruses.
“Pesticide laws protect people who use these products and ensure products work as they claim to. Companies must be held accountable when they violate these requirements,” said Regional Administrator Dr. Earthea Nance. “EPA’s pesticide and enforcement teams have worked hard throughout the pandemic to ensure products are registered and labeled correctly, especially pesticides that claim to fight viruses.”
Under the settlement, Allied BioScience agreed to a civil penalty of $253,032, based on the company’s financial ability. EPA previously issued a Stop Sale, Use or Removal Order (SSURO) to Allied BioScience for SurfaceWise2. The product was authorized for emergency use at specific sites in the states of Arkansas, Oklahoma and Texas to help address the COVID-19 pandemic. EPA investigations found the company was marketing, selling and distributing SurfaceWise2 outside of the terms and conditions of the emergency exemption authorizations.
The SSURO issued to Allied BioScience required the company to immediately stop selling and distributing SurfaceWise2. Additionally, EPA revoked SurfaceWise2 emergency exemptions for Arkansas and Texas due to scientific concerns regarding product performance. EPA laboratory testing indicated the product's performance was more variable under real-world conditions, particularly when it is exposed to moisture or abrasion. Recently, EPA modified the SSURO issued to Allied BioScience to allow for the product to be distributed outside the United States bearing revised export labeling and to allow returns of the product to Allied Bioscience. The SSURO remains in effect with respect to all other stocks of the product subject to the order and product not bearing the revised export labeling, unless revoked, terminated, suspended or modified in writing by EPA.
Given the product’s limited approved scope of use and CDC guidance that states the risk of transmission for SARS-CoV-2 by touching a contaminated surface is considered to be low, removing this unregistered product from the market does not endanger human health or limit the fight against the virus. EPA has registered many other products for decontaminating surfaces when the need arises.
In August 2020, after reviewing the available data and information, EPA issued the initial SurfaceWise2 emergency exemption for specific locations under Section 18 of FIFRA. SurfaceWise2 was expected to kill coronaviruses like SARS-CoV-2 on surfaces for up to seven days when used as a supplement to a List N disinfectant. List N is a list of products that EPA expects will kill SARS-CoV-2, the coronavirus that causes COVID-19, when used according to the label directions.
In May 2021, EPA received a revocation request from Oklahoma indicating the emergency situation was no longer applicable in the state. July 8, 2021, EPA accepted Oklahoma’s rationale and revoked the state’s emergency exemption on those grounds. This action was in addition to revoking the emergency exemptions for Arkansas and Texas.
Section 18 of FIFRA authorizes EPA to exempt state and federal agencies from provisions of FIFRA and allows unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of a pesticide in defined geographic areas for a finite time once EPA confirms the situation meets the statutory definition of "emergency condition" and the product will not cause unreasonable adverse effects on human health or the environment.
To ensure emergency exemptions are effectively addressing an emergency, EPA’s regulations require additional recordkeeping and reporting beyond those that apply to registered pesticides. EPA’s regulations also include provisions for EPA to unilaterally modify or revoke emergency exemptions if deemed necessary.
For additional information on the coronavirus: www.epa.gov/coronavirus
Members of the public can help protect our environment by identifying and reporting environmental violations. Learn more here: https://www.epa.gov/enforcement/report-environmental-violation-general-information.
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