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EPA Revokes Exemption for Antimicrobial Coating

Monday, July 12, 2021

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The U.S. Environmental Protection Agency Stop Sale, Use or Removal Order to Allied BioScience for its product SurfaceWise2, a residual antimicrobial surface coating.

The product was approved last August for emergency use in. Arkansas, Oklahoma and Texas in light of the COVID-19 pandemic, however, the EPA now says that investigations have found that the company was marketing, selling and distributing SurfaceWise2 “in ways that were inconsistent with the Federal Insecticide, Fungicide, and Rodenticide Act, EPA’s regulations and the terms and conditions of the emergency exemption authorizations.”

The SSURO that requires the company to immediately stop selling and distributing SurfaceWise2. The SSURO will remain in effect unless revoked, terminated, suspended or modified in writing by the EPA.

© iStock / Skyhobo

The U.S. Environmental Protection Agency Stop Sale, Use or Removal Order to Allied BioScience for its product SurfaceWise2, a residual antimicrobial surface coating.

The emergency exemptions for the product in Arkansas and Texas are also revoked. The EPA cites new data and testing that 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.”

Allied BioScience has not yet responded to requests for comment.

Background

As states, the EPA approved the emergency exemption of the product in August 2020 under former Administrator Andrew Wheeler, and was the first long-lasting antiviral product approved by the EPA for use against COVID-19.

“There is no higher priority for the Trump Administration than protecting the health and safety of Americans and I want to thank those who have worked with us to achieve this major milestone,” said Wheeler at the time.

“Since day one, I have been committed to ensuring that Americans have as many tools as possible to protect their families and today we are delivering on that promise by approving the first-ever long-lasting antiviral product that will help fight the spread of the novel coronavirus.”

The initial findings of the product supported that it inactivates viruses and bacteria within two hours of application and continues to work against them for up to seven days.

In January 2021, after the tests that reveal that exposure to moisture could adversely impact the product’s durability, the EPA revised its terms of use for the product. In May, the EPA received a revocation request from Oklahoma, indicated that the emergency situation that prompted the approval in the first place was no longer applicable.

Other Exemptions

This isn’t the only product that’s been given an emergency exemption under Section 18 of the Federal Insecticide, Fungicide and Rodenticide Act. More recently, specialty polymers company Kraton Corporation received as exemption in May submitted by the Georgia, Utah and Minnesota Departments of Agriculture, for the deployment of its BiaXam copolymer for specific applications.

The exemption allows Delta Air Lines to use BiaXam in applications to help protect against SARS-CoV-2.

According to Kraton, BiaXam sulfonated block copolymer is a solid yet transparent material that aims to provide long-lasting antimicrobial protection on public surfaces. The company notes that the technology can kill up to 99.999% of the SARS-CoV-2 virus under laboratory conditions, with continued protection for up to 200 days, depending on use, exposure and cleaning methods.

Kraton developed BiaXam as part of its sulfonated polymer product line and is currently seeking regulatory approvals in other jurisdictions.

As for Delta, it will be the launch customer of the product, starting with the airline’s Atlanta, Salt Lake City and Minneapolis kiosks and counters.

“We believe that BiaXam is unique due to both its efficacy, durable and residual properties that distinguish it from other technologies that require a more frequent application or treatment. We are not aware of other available technologies that provide the long-lasting, durable protection that BiaXam can offer. Moreover, while other antimicrobial products are based upon a chemical as the active ingredient, BiaXam is a polymer, and the antimicrobial properties are an inherent feature of the polymer design,” said Kevin M. Fogarty, Kraton's President, and Chief Executive Officer.

“We appreciate the EPA and the States of Georgia, Minnesota and Utah for their diligent evaluation of BiaXam's durability and efficacy data. We are eager to continue our work with Delta Air Lines, a global airline leader in safety, innovation, reliability, and customer experience as they work to expand their commitment to passenger safety.”

According to the company, the patent-pending technology can be coated on various substrates and surfaces such as plastic, metal and glass. It can also be applied as a peel-and-stick film. The company adds that the technology has been studied by organizations including Boston University's National Emerging Infectious Diseases Laboratories, North Carolina State University, University of Texas Medical Branch at Galveston and Syngene International Ltd.

Antiviral Research

Throughout the past year there has been a rush of coatings-related research to combat the COVID-19 pandemic.

In March 2020, research at the University of Witwatersrand, Johannesburg, revealed a new self-sanitizing surface coating that aims to help address infection control in hospitals, food processing plants, public transportation and other commercial places.

The unique features of that research, according to the university, include the novelty of multi-step and multi-process additive manufacturing through the use of cold spray and polymer 3D printing.

In April, University of Central Florida researchers announced that they were working to create a protective coating that would specifically target and kill the COVID-19 virus. The plan was to create nanostructures to capture the virus and then trigger a chemical reaction using ultraviolet light to kill it.

The nanostructures will be created at UCF’s main campus and then shipped to a lab at the College of Medicine for tests to see which materials kill specific viruses and how fast.

In early May, researchers at the Hong Kong University of Science and Technology announced that they had developed a multilevel antimicrobial polymer (MAP-1) coating that they say is effective in killing viruses, bacteria and spores.

The coating reportedly prevents microbial adhesion on a surface by using the special blend of antimicrobial polymers, effectively killing “99.9% of bacteria and viruses.”

Later that month, researchers from the Ben-Gurion University of the Negev, in Israel, announced that they were also working with metals and are developing a novel surface coating that aims to “contain nanoparticles of safe metal ions and polymers with anti-viral and anti-microbial activity,” a route in combating the pandemic.

Based on their findings, they are developing an anti-viral coating that can be painted or sprayed onto surfaces.

In June, research out of Montreal’s Concordia University is looking into antiviral metallic and ceramic coatings as a way to slow the transmission of COVID-19.

Then, in July, multiple breakthroughs were announced that included an omniphobic coating out of the Okanagan Polymer Engineering Research and Applications Lab (OPERA), at the University of British Columbia Okanagan, aimed at protecting face shields, and an antiviral coating from the Waterloo Institute for Nanotechnology within the University of Waterloo that aims to “kill the COVID-19 virus immediately upon contact.”

In August, a chemical engineering professor at Virginia Tech announced that he has developed his own coating—meant for glass or stainless steel—that inactivates the virus within an hour.

And, most recently, in November, researchers from the University of Liverpool were awarded 615,000 pounds (roughly $809,235) in funding to develop a new antiviral coating for PPE.

Led by Raechelle D’Sa and Jenny Hanson, from the University’s School of Engineering, the research aims to develop a new coating with both antiviral and antifouling properties that can be applied to PPE surfaces.

   

Tagged categories: Anti-microbial; COVID-19; EPA; EPA; Government; Health & Safety; Health and safety; NA; North America; Regulations; Safety

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