Pesticide devices: The US regulatory landscape

As the world becomes acutely aware of the importance of effective cleaning and disinfection, new and novel products that address the disinfection or sanitization of surfaces, water, and air are increasingly being developed and sold. Many non-chemical products, such as those that use UV light or ozone to kill microbial contamination, are becoming more prevalent in the US market. However, the regulatory landscape for approving such antimicrobial pesticide devices is not as straightforward as one may think.

In this paper, we discuss how antimicrobial pesticide devices are regulated in the United States (US) and provide recommendations on how companies can address their compliance obligations.

Pesticide devices: The US regulatory landscape

Manufacturers of chemical antimicrobial products as well as their customers are increasingly looking for alternative technologies to replace or supplement traditional antimicrobials. Institutions are developing more comprehensive processes to sanitize and disinfect the harder to reach surfaces in hospitals, offices and other public places. In addition, consumer demand is growing for different, often non-chemical options, to keep keeping homes germ free.

Non-chemical products, such as UV light generators, air ozonation units, and salt chlorine generators are increasingly being incorporated into sanitization and disinfection strategies as adjunct to primary disinfection methods. Often considered “pesticide devices” by the US

Environmental Protection Agency (EPA), these products do not go through the same rigorous registration standards as a “pesticide product”.

While the regulatory approval process and compliance of these antimicrobial pesticidal devices is significantly less onerous than it is for traditional chemical antimicrobial products, pesticide devices must still comply with various federal requirements and state registration standards. In addition, US EPA expects companies to have available all scientific data to support claims.

Going down the antimicrobial pesticide device route is also an attractive option for companies seeking to get antimicrobial products to market quickly at lower cost. However, before developing these novel products, it is important to ensure that the EPA deems the product a device versus an antimicrobial pesticide.

For all pesticide devices, it is also important to ensure that any efficacy claims are substantiated, both to provide consumer confidence, as well as meet EPA requirements.