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The COVID-19 outbreak has caused tumultuous effects upon the nation’s economy, healthcare resources, small and large business, and individual behavior. We are observing in real time significantly increased demand for cleaning products and online purchasing and home delivery services as people focus on exposure prevention and practice social separation. Could these forces be converging to lay the foundation for significant enforcement actions in the future under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”)?
Under FIFRA §3(a), no person in any State may distribute or sell to any person any pesticide that is not registered with the Environmental Protection Agency (“EPA”). A “pesticide” is broadly defined to include any substance intended for preventing, destroying, repelling or mitigating any pest. A “pest” is defined to include, among other things, a virus, bacteria or other micro-organism. Consequently, any substance that is promoted or claimed to prevent, destroy, or mitigate a virus becomes a “pesticide” which must first be registered with the EPA. Registration is a lengthy and expensive process that can take approximately a year to complete. As part of the registration process, the EPA must approve all labeling, claims, and packaging used with the pesticide and validate the efficacy and safety of the product. As a result, producers, shippers, and retailers of products that are marketed to address the COVID-19 virus, risk violating FIFRA §3(a) by selling or distributing such products, unless the products have already been registered with EPA.
EPA takes the position that, under FIFRA, each sale or distribution potentially represents a separate and distinct violation of the statute. Thus, during this time of increased e-commerce, with people confined to their homes, each click of a mouse resulting in the purchase of unregistered disinfectants that promote their effectiveness against the COVID-19 virus, potentially exposes the selling retailer to enforcement. In addition, EPA’s view is that each shipment or delivery of those products, including to the ordering consumer, or among distribution centers or retail establishments, represents a potential additional basis for enforcement liability for shippers or producers of the products.
Within such a liability framework, the multiplication effects of online sales platforms can be enormous in the calculation of the final penalty that EPA could seek for the sale or distribution of unregistered COVID-19 virus-targeted disinfectants. In other contexts, online retailers have previously experienced the economic pain of EPA’s enforcement with respect to the use of their platforms for the sale of unregistered pesticides. As specifically related to the COVID-19 virus, in a phone call on April 3, 2020, EPA Administrator Wheeler warned online retailers to be vigilant in avoiding placement of unregistered products on their platforms that make potentially problematic COVID-19 virus disinfectant claims.With such notice, the stakes for online retailers are now even higher in the event of any missteps regarding the sale of unregistered COVID-19 virus-targeted products.
Retailers.EPA has published a list of all products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. These products have registration numbers that should be reflected on any label for a product purporting to address the COVID-19 virus. Retailers can check products available for sale against this list, which EPA continues to update.
Product manufacturers.For manufacturers whose products have already been approved and registered for addressing other types of viruses, in August 2016, EPA published a document, Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.In that guidance, EPA sets forth a two-step process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label but that belong to the same viral subgroups that the product is already approved to address. In the first step, which could be pursued before an outbreak, registrants with eligible disinfectant products may submit a request, using a label amendment, to control an emerging viral pathogen by adding a prescribed form of statement to the master label and additional terms to the product registration. The prescribed statement would, in essence, be “on the shelf” ready to incorporate into certain product communications once an outbreak occurs.
After EPA’s approval of that amendment, in the second step, which would apply during an outbreak caused by an emerging virus, registrants having the previously approved label amendments would be allowed then to use the prescribed statement in off-label communications intended to inform the user that the product may be used against the specific pathogen, in this case, SARS-CoV-2, provided that the virus has been designated by the Center for Disease Control as belonging to the same viral subgroups that the product is already approved to address.
COVID-19 represents a unique healthcare and economic challenge to our nation. The interest in quickly mitigating and overcoming this challenge may result in the offering of disinfectant products that are subject to a complex regulatory environment, requiring EPA registration and approval. Without appropriate care, manufacturers, shippers and retailers of such products may find themselves distributing or selling unregistered products, thus potentially exposing themselves to enforcement actions that seek significant penalties. Retailers with online sales and delivery platforms face a unique risk of high penalties because of the scale of sales and distribution that such platforms permit. Retailers should be attentive to these issues, confirming that COVID-19 disinfectant products are registered with EPA. Manufacturers, if they already have products registered with EPA for similar viruses, have a means for making claims regarding the COVID-19 virus provided they follow EPA’s guidance on the subject.
Please visit our COVID-19 Resource Center often for up-to-date information to help stay informed of the legal issues related to COVID-19.