The much talked about, SurfaceWise2 long-lasting hospital grade disinfectant has been issued a 'Stop Sale, Use Or Removal Order' by the EPA in the US. The product manufacturer, Allied BioScience, has been ordered to immediately stop selling and distributing this product.
In Australia, as at 21st of July 2021, SurfaceWise2 is still a listed hospital grade disinfectant by the TGA (Therapeutic Goods Administration). With the EPA's ban on this product, announced 8th July 2021, you could expect the TGA to review this product's regulatory status and product claims in the very near future.
Larry Starfield, EPA acting assistant administrator for the Office of Enforcement and Compliance Assurance stated, “Pesticides can cause serious harm to human health and the environment, which is why EPA requires their registration before being distributed for use. EPA is committed to holding companies accountable for not adhering to federal environmental laws.”
According to Hospital and Healthcare Magazine, the SurfaceWise2 product is a hospital-grade disinfectant that protects surfaces from germs for up to three months. Allied BioScience Australia website claims, "SurfaceWise2™ forms a protective coating to provide residual efficacy on surfaces to reduce germs by up to 98.5% over 15 weeks (105 days)". They go on to state, "Our infection control system leverages a unique long-lasting ARTG Listed antimicrobial coating, Allied BioScience’s SurfaceWise2™, combined with a specialised preparation and application process. This enables the continuous protection of surfaces and air conditioning systems against germs, bacteria and COVID19 for up to 3 months."
Many hospital grade disinfectants offer residual protection against germs for a period of time (even though no claims are often made). To test a long lasting hospital grade disinfectant in real world conditions and then make specific claims or guarantees about the length of time protection is provided, to our knowledge hasn't been done before with the regulators. It is important to note that the EPA did originally give SurfaceWise2 an emergency exception which may have bypassed their regular process.
It was reported by the EPA that the SSURO issued to Allied BioScience was in part due to "scientific concerns regarding product performance."
In their press release the EPA noted, "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."
The point made by the EPA is exactly why at XO2 we do not make residual claims for our Disso hospital grade disinfectant that is TGA listed and proven to kill COVID-19. In the real world (not lab world), giving a long-lasting residual disinfecting guarantee is near impossible given the unknown exposure a surface may have to moisture and the unknown abrasion a surface may experience.