EPA Issues Civil Penalty for Antimicrobial Coating

THURSDAY, MARCH 17, 2022


Last week, the U.S. Environmental Protection Agency announced that a settlement had been reached with Allied BioScience, Inc. over alleged violations of federal pesticide regulations with the company’s product SurfaceWise2, a residual antimicrobial surface coating. 

According to an investigation conducted by the EPA, Allied BioScience was marketing, selling and distributing SurfaceWise2 in ways that were inconsistent with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The methods also went against EPA regulations and the Agency’s terms and conditions of its emergency exemption authorizations, specifically regarding 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.”

SurfaceWise2 Background

Back in August 2020, the EPA approved an emergency exemption for SurfaceWise2 under former Administrator Andrew Wheeler. At the time, the product made by Allied BioScience was the first long-lasting antiviral product approved by the EPA for use against COVID-19.

The initial findings of the product supported that it inactivated viruses and bacteria within two hours of application and continued to work against them 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, 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request from Oklahoma, indicating that the emergency situation that prompted the approval in the first place was no longer applicable.

The state was later joined by Arkansas and Texas, who claimed that the company was marketing, selling and distributing SurfaceWise2 in ways that were inconsistent with FIFRA.

By July, the EPA announced that it would be revoking its exemption for the antimicrobial coating through a Stop Sale, Use or Removal Order (SSURO) in all three states, which would remain in effect unless revoked, terminated, suspended or modified in writing by the EPA. In its decision, the EPA cited that new data and testing indicated that “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.”

The SSURO required the company to immediately stop selling and distributing SurfaceWise2.

What Now

After confirming through an investigation that Allied BioScience was marketing, selling and distributing SurfaceWise2 outside of the terms and conditions of the emergency exemption authorizations, the Agency issued a civil penalty totaling $253,032.

Created based on the company’s financial ability, Allied BioScience has agreed to pay the penalty and since July 2021, has ceased all sales and distribution of SurfaceWise2.

However, recently the EPA announced that it had modified the SSURO issued to Allied BioScience so that the company could distribute the product outside the United States, should it include a revised export labeling and allow returns of the product to Allied Bioscience.

The SSURO will remain 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.

The EPA concludes that 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.

Other Exemptions, Antiviral Research

According to reports, SurfaceWise2 isn’t the only product that’s been given an emergency exemption under Section 18 of FIFRA.

Around the same time the coating was being investigated, specialty polymers company Kraton Corporation was issued an exemption in May 2021. The revocation request was submitted by the Georgia, Utah and Minnesota Departments of Agriculture, for the deployment of its BiaXam copolymer for specific applications.

The exemption allowed 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 at the time, was seeking regulatory approvals in other jurisdictions.

As for Delta, the airline planned to launch customer of the product, starting with Atlanta, Salt Lake City and Minneapolis kiosks and counters. According to Kraton, 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.

Throughout much of 2020 and 2021, there was a such 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.

Researchers from the University of Liverpool were awarded 615,000 pounds (roughly $809,235) in funding in November 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.

More recently, in October 2021, researchers from The University of Queensland were reported to develop an effective, antiviral surface coating technology against SARS-CoV-2.

Designed to use as an extra layer of protection against COVID-19 and the flu, the spray-applied technology for surfaces and face masks was developed with Boeing as a joint research project and was tested at the Peter Doherty Institute for Infection and Immunity at The University of Melbourne.

According to UQ’s Australian Institute for Bioengineering and Nanotechnology researcher Professor Michael Monteiro, the water-based coating technology works by deploying worm-like structures that attack the virus.

That same month, global coatings manufacturer PPG announced that it had received U.S. Environmental Protection Agency registration for its PPG Copper Armor antimicrobial paint. The coating contains Corning Guardiant technology, proven to kill 99.9% of bacteria and viruses on the painted surface within two hours, including SARS-CoV-2.

And earlier this month, it was reported that a team of researchers from the Department of Nano-Bio Convergence of the Korea Institute of Materials Science developed a material that provides antibacterial and antiviral properties without changing the physical properties of various products that are commonly used.

The team reports that the antibacterial/antiviral additive is composed of non-toxic substances without organic antibacterial agents and nano compounds. In addition, when used as an additive, the material can carry out ultraviolet and heat curing processes without additional processing on existing products.

   

Tagged categories: Antibacterial coatings; Anti-microbial; Antimicrobial coatings; Coating Materials; Coating Materials - Commercial; COVID-19; Environmental Protection Agency (EPA); EPA; EPA; Good Technical Practice; Government; Health & Safety; Health and safety; NA; North America; Regulations; Safety

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