The U.S. Environmental Protection Agency (EPA) has issued a Stop Sale, Use or Removal Order (SSURO) to Allied BioScience for their product SurfaceWise2. SurfaceWise2, a residual antimicrobial surface coating, was previously authorized for emergency use in Arkansas, Oklahoma, and Texas to help address the COVID-19 pandemic. 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 the emergency exemption authorizations. Specific use sites included American Airlines aircraft and airport facilities and two orthopedic facilities in Texas.
As a result, EPA issued a SSURO that requires Allied BioScience, the product manufacturer, to immediately stop selling and distributing SurfaceWise2. The SSURO will remain in effect unless revoked, terminated, suspended or modified in writing by EPA.
“Pesticides can cause serious harm to human health and the environment, which is why EPA requires their registration before being distributed for use,” said Larry Starfield, EPA acting assistant administrator for the Office of Enforcement and Compliance Assurance. “EPA is committed to holding companies accountable for not adhering to federal environmental laws.”
Additionally, EPA is revoking SurfaceWise2 emergency exemptions for Arkansas and Texas due to the company misconduct described above and scientific concerns regarding product performance.
Since January, new data have become available, leading EPA to comprehensively review new and existing information. EPA laboratory testing indicates the product's performance is less reliable under real-world conditions, particularly when it is exposed to moisture or abrasion. Therefore, based on all the available efficacy data for SurfaceWise2, EPA does not support its continued emergency use.
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.
Background:
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 January 2021, EPA revised the terms and conditions under which SurfaceWise2 could be used after an initial review of internal laboratory data revealed that exposure to moisture could adversely impact the product’s durability, reducing its residual efficacy. EPA’s revised terms of use applied to Texas and two additional states that received emergency use exemptions in January—Arkansas and Oklahoma.
In May 2021, EPA received a revocation request from Oklahoma indicating the emergency situation was no longer applicable in the state. Today, EPA is accepting Oklahoma’s rationale and revoking the state’s emergency exemption on those grounds. This action is 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 allow 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.
Source: EPA
