Since the SARS-CoV-2 pandemic began, many companies have continued to develop antimicrobial products and devices to address health and safety concerns. Many of those companies are surprised to learn that the way in which they are marketing their products may subject them to regulation by EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
If your company’s product marketing includes a “pesticidal claim,” the product is regulated under FIFRA, and it is subject to requirements for EPA and state registrations, reporting, import notices, and compliant product claims and labeling. The failure to comply with FIFRA can result in an EPA order to stop the sale of the product and the issuance of large civil or criminal penalties. Below is a summary of how FIFRA is triggered and of its key requirements.
A “pesticidal claim” under FIFRA is any claim that a product or device may prevent, destroy, repel, or mitigate any pest. “Pest” is broadly defined under the Act to include any terrestrial or aquatic plant life or virus, bacteria, or other microorganism. In light of this, all product claims related to the control or mitigation of bacteria or viruses (including SARS-CoV-2) trigger FIFRA regulation. FIFRA regulates pesticide products with active chemicals or other ingredients used to destroy or inactivate microorganisms, such surface wipes and sprays, and devices that use mechanical means to capture microorganisms, such as filters and UV lights. A pesticide device that contains an active ingredient may be deemed a pesticide product rather than a pesticide device.
Pesticide products must be registered with EPA; the registration can be a fairly long process and involves the submission of technical and scientific data to EPA to demonstrate the product’s claims. If a pesticide product contains a new active ingredient or proposes a new use of an existing active ingredient, the applicant must commission studies to generate data necessary for product registration. EPA may take up to 24 months to review and approve such a registration. The product-registration process may be quicker if the applicant files a “me too” registration that allows the applicant to use existing data for an already registered active ingredient approved for the same uses.
Unlike pesticide products, pesticide devices do not have to be registered. However, they must be made in an EPA-registered establishment, and the registered establishment must comply with periodic reporting requirements. Importers of pesticide devices must also file a Notice of Arrival of Pesticides and Devices with EPA upon the entry of each shipment. In addition, all pesticide devices must comply with certain labeling requirements. Regulation of pesticide products and devices is not limited to EPA. Some states have separate pesticide programs—currently, eleven states require the registration of pesticide devices if the product is sold in those states.
One aspect of FIFRA that is often enforced by EPA is the prohibition on the sale of misbranded pesticide products and pesticide devices. A “misbranded” product is one that does not bear the establishment or product registration number; does not include any word, any statement required for registration approval or by the regulation; or does not include directions for use that are adequate to protect public health and the environment. A misbranded product is also one for which the product labeling or other marketing contains false or misleading statements. For pesticide devices, which do not require the submission of efficacy data to EPA, it is critical that the company ensure that the claims about the product are adequately supported by appropriate data and studies. That means that there is supporting data specific to the claims, the type of pest or microorganism and the use of the device.
EPA has broad enforcement authority under FIFRA. It may issue a Stop Sale, Use, or Removal Order (SSURO). EPA often issues a SSURO to stop the sale of a product until it can be relabeled to comply with the Act. For unregistered products, this often means removing any pesticidal claims. It may also mean removing any claims that EPA deems are false or misleading.
Civil penalties for violations of FIFRA can be assessed up to $19,446 per product shipped or sold. As the total penalty is based on the total number of violating products, FIFRA penalties can be quite high, often reaching into seven figures. Last year, EPA issued one of the largest civil penalties ever under FIFRA—a $6.9 million penalty against Electrolux for the import of unregistered antibacterial filters containing nanosilver.
FIFRA is a statute that many companies unwittingly violate by making pesticidal claims without properly registering the product or for failing to follow other regulatory requirements. EPA has made the enforcement of FIFRA a priority. There is heightened scrutiny for products making antimicrobial claims. Claims involving the efficacy against SARS-CoV-2 are especially concerning to EPA, and there are specific EPA policies and procedures regarding the permissible marketing and sale of products making those claims.
When considering a new product, it is helpful to review claims on the product label and related product brochures and website materials. If you want to make any pesticidal claims, you should evaluate the regulatory requirements that may be triggered by those claims and how those may impact the timing of the product in the marketplace.