Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), most pesticides must be registered and are subject to product labeling requirements. FIFRA defines a “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” 7 U.S.C. § 136(u). A “pest” is defined in the statute to mean: “(1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under section 136w(c)(1).” 7 U.S.C. § 136(t).
Pesticide products that are intended for a “pesticidal purpose” must obtain a registration from the Environmental Protection Agency (“EPA”), unless they are covered by an exemption from the implementing rules in 40 C.F.R. Part 152. If the seller or distributor of a product claims or implies that the product prevents, destroys, repels or mitigates a pest, then the product is considered to be intended for a “pesiticidal purpose.” Thus, if a product is claimed or implied to destroy, repel or mitigate the COVID-19 virus on its label or other product literature (including websites), then such product must be registered with EPA under FIFRA. Each act of sale or distribution of an unregistered pesticide is a violation of FIFRA subject to enforcement action.
Key exclusions are set forth in 40 C.F.R. § 152.10, which provides in part:
(a) Deodorizers, bleaches, and cleaning agents;
(c) Products that are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants, such as certain pruning paints to trees.
(Emphasis added.) (Additional exclusions are beyond the scope of this article.) So to the extent a deodorizer, bleach, or cleaning agent does not make a “pesticidal claim,” then the FIFRA rules do not apply. However, be aware that the term “pesticidal claim” is relatively broad. EPA will consider claims of antimicrobial properties and/or having a similar composition to a FIFRA-registered product as evidence that the registration process is required.
Fortunately, EPA has published a list of pesticide products that have been registered with EPA and meet the criteria for use against the SARs-CoV-2 virus that causes COVID-19. The list is available at: https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2. EPA will be updating the list as additional products are registered and meet its criteria. These products may be sold for use to combat COVID-19 without fear of enforcement by EPA under FIFRA (provided no claims are made on their label or marketing materials, including websites, that go beyond the approved product registration statements submitted to EPA for the FIFRA registration).
In August 2016, EPA also adopted guidance under FIFRA to “identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens.” This guidance and process apply only to emerging viruses. Titled “Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels,” the guidance establishes a fast-track two-step process for obtaining FIFRA approval for products already registered as effective against the same viral subgroup. The first step requires the registrant to request an amendment to its product label to indicate that the product may be effective against emerging viruses in the same sub-group as it is already approved for. This can be done before or during an emerging virus outbreak. In the second step, the FIFRA approved label amendments could be used in off-label communications intended to inform users of the product that the product may be used against the specific emerging virus, but only after the Centers for Disease Control and Prevention has identified the emerging virus (so that is sub-group can be identified) and has recommended environmental surface disinfection to help control its spread.
EPA has announced that it will take aggressive enforcement action under FIFRA with regard to sale of unregistered disinfectants to protect the public. EPA has also indicated it will take enforcement action against sellers of registered products to prevent fraud and false claims concerning the ability of such disinfectants to combat COVID-19 where the claims are not supported by the product registration. For example, the seller of a product registered under FIFRA as being effective to combat bacteria, could not claim that the product is effective against a virus without going through the FIFRA registration process with regard to the virucidal properties of the product. EPA inspectors, federal law enforcement officers, and certain state environmental and law enforcement entities will assist with inspections and enforcement. EPA has indicated that it will use both its “stop-sales” order authority and penalty authority under FIFRA to prosecute violations of FIFRA.
For more information, contact Lauren Rucinski or Maureen Harbourt.