Manufacturing Disinfectants 101: An Introduction to Regulatory Requirements

Since the COVID-19 outbreak, there has been a rush to enter the disinfectant industry to seize upon the significant need but short supply of disinfectant products. Because the U.S. Environmental Protection Agency (EPA) and individual states regulate disinfectants as pesticides, so many entering this market for the first time are quickly discovering the complicated steps that one must go through to bring a pesticidal product—such as a disinfectant—to market.  While there are many crucial considerations, this will provide an introduction to manufacturing disinfectants and the regulatory requirements.

Disinfectants may contain chemicals with potentially toxic or harmful characteristics and, for that reason, the U.S. EPA regulates these products pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). This includes a thorough but necessary registration process involving supporting data to ensure effectiveness and safety before granting a registration and allowing “pesticidal” claims (e.g., “Kills 99.9% of bacteria and viruses”).

General Considerations for Manufacturing Pesticide Products as Disinfectants

• Disinfectants (such as hard surface disinfectants) are pesticides regulated by the U.S. EPA. Cleaners and hand sanitizers are not. The U.S. EPA takes the position that “the label is the law.” In other words, if a product is marketed as a pesticide, the U.S. EPA and state agencies will regulate it as a pesticide.
• Pesticides must be registered with the U.S. EPA, and subsequently in each individual state where the product will be distributed or offered for sale. This is often a time-intensive process that could take several months.
• Pesticides must be produced at a facility that is registered with the EPA and therefore has its own EPA Establishment Number. In this context, “produce” means to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.
• Each word and picture on a pesticide label, including but not limited to logos, icons, and marketing and safety statements, must be pre-approved by the U.S. EPA and individual states before inclusion on a marketplace label. Most changes to labels must also obtain prior approval by the U.S. EPA and states.
• The U.S. EPA is not currently expediting new registrations of disinfectants because of the COVID-19 outbreak. It is expediting claims and label amendments associated with existing registrations.

While it can be costly to adhere to the detailed regulatory requirements, noncompliance such as marketing an unregistered or unapproved label, or otherwise failing to adhere to regulations, may lead to agency enforcement and possibly state civil actions for failure to warn, false advertising, or similar.

The Environmental Law Team at Rhoades McKee has extensive experience in pesticide regulation and can assist with matters regarding new products for entry into the market, ongoing compliance assistance, enforcement defense, civil litigation, and general business needs. For any additional questions regarding the regulatory and compliance requirements of manufacturing disinfectants, please contact Audrey Patterson or another member of the Environmental Law Team.