Companies could face difficulties registering cleaners and disinfectants with claims of “long-lasting” effectiveness against COVID-19, says TSG Consulting
WASHINGTON DC: Firms hoping to bring products to market in the US with claims of “long-lasting” effectiveness against SARS-CoV-2, the novel coronavirus that causes COVID-19, may face unexpected hurdles, despite a recent announcement by the Environmental Protection Agency (EPA), experts have advised.
These “cutting edge” cleaners and disinfectants are designed to keep surfaces free of viruses and bacteria for days, weeks, months or even years after they are applied – unlike traditional products, which only kill the pathogens present when they are applied.
With consumers, businesses and politicians eager to keep homes, offices and public spaces virus-free, companies are clambering to have their products labelled as a “long-lasting”. While EPA’s new guidance opens the door for registration of long-lasting antimicrobials, experts at TSG Consulting say firms may find that this is not as simple as they think.
Erin Tesch, Senior Vice President and Managing Director at the company, said: “This is a really positive move by the EPA and will benefit both commerce and consumers, by giving them access to ‘long-lasting’ products that offer microbial reduction between disinfections.
“However, manufacturers need to be aware of some of the hurdles they may face in registering new products and updating the claims of existing ones. While firms may feel that the process will be quick, easy and inexpensive, they may find that – without expert guidance – it is none of these things.
“TSG’s knowledge of the industry and history of the marketplace makes us ideally placed to help companies navigate the new guidance, and many of the already existing ‘long-lasting’ products on the market were registered by us.
“We have in-depth understanding of EPA’s new protocols, can assist in claims development and coordinate with efficacy testing labs, ensuring scientists are being asked to perform the right tests and get the data that a firm needs for the claims they want to make.”
The advice comes as EPA issued draft guidance for firms manufacturing pesticides that provide residual efficacy against bacteria and viruses. It provides a faster registration route to ensure that products which clean and disinfect surfaces to combat viruses like SARS-CoV-2, the coronavirus that causes COVID-19, are brought to market as soon as possible.
EPA will begin expediting the registration process for these products immediately, although the regulator may revise this guidance within 60 days, after the public has had a chance to comment on the changes.
Speaking at the time, EPA Administrator Andrew Wheeler said: “EPA is providing an expedited path for our nation’s manufacturers and innovators to get cutting-edge, long-lasting disinfecting products into the marketplace as safely and quickly as possible.
“As we continue to re-open our schools, workplaces, and other public spaces, it is important Americans have as many tools as possible to slow the spread of COVID-19.”
TSG's consultants can assist companies with data development and review, drafting product label and claims, and assembling submission packages to comply with EPA’s draft guidance, under which applicants must address specific efficacy testing and labelling requirements for two different types of products, in addition to standard disinfectants.
Supplemental residual antimicrobial products work within two hours of a virus or bacteria encountering a surface and can remain effective for weeks to years. Antimicrobial coatings and films have a residual efficacy measured in weeks, while antimicrobial fixed or solid surfaces, with residual efficacy measured in years. Both can supplement, but do not replace, routine cleaning and disinfection using EPA-approved products for use against COVID-19.
Residual disinfectants must clear a higher standard of efficacy. They are effective within 10 minutes of a virus or bacteria contacting a surface and remain effective for up to 24 hours. Surfaces treated with residual disinfectants do not require additional cleaning or disinfection during this period.