For the first time ever, EPA has approved a pesticide making residual antiviral claims under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The approval may be a significant boon in the fight against COVID-19, but it also raises several key questions about EPA’s broader approach to combatting the novel coronavirus.

EPA’s Historic Approach to Residual Antiviral Products

Products that are sold with antiviral claims must typically be registered as pesticides under Section 3 of FIFRA, which can take 18-24 months.  EPA has historically declined to approve products making residual antiviral claims (i.e., claims that a product remains effective against viruses hours, days, or longer after its application), and during the current pandemic has informed applicants that they must develop their own testing protocol in support of such products.  Development of such testing protocols can be a lengthy and expensive process, with EPA taking a year to review the protocols alone.  Once such a protocol is approved, an applicant would then need to generate efficacy data and submit a registration application. While this process helps ensure that robust efficacy data underlies such registrations, it can also limit innovation and hinder EPA’s ability to react rapidly to developments like the COVID-19 pandemic.

The Granted Exemptions & Their Significance

In a shift away from its historic approach, on August 24, EPA issued two public health emergency exemptions to the Texas Department of Agriculture.  The exemptions allow Texas to permit an airline and a orthopedics clinic to use a new surface coating that inactivates coronaviruses like SARS-CoV-2 for up to seven days.  The exemptions last one year.     The exemptions were issued pursuant to Section 18 of FIFRA, which authorizes EPA to grant state and federal agencies emergency exemptions for unregistered uses of pesticides to address emergency conditions.  Section 18 exemptions allow applicant agencies to oversee the limited use of an unregistered pesticide in defined geographic areas for a finite time.  Only federal and state agencies can apply for Section 18 emergency exemptions.

Unanswered Questions

This unprecedented use of emergency exemptions creates more questions than answers about EPA’s long-term strategy to combat COVID-19 and its plan for residual disinfectant products, including:

How will EPA evaluate data about a residual antiviral product’s efficacy?  Texas submitted data demonstrating the coating’s success against an EPA approved surrogate coronavirus and bacteria.  However, EPA has not released a summary of such data, a description of the protocol used to generate the data, or an explanation of the standard by which such data will be measured.  Accordingly, what EPA will require for future applicants remains unclear.

How will this impact EPA’s issuance of regular registrations for products making residual antiviral claims?  EPA has also not explained how the efficacy data requirements it applied to this Section 18 emergency exemption differed from those applicable to standard Section 3 registrations, other than to explain that the submitted data for this product do not “qualify for registration under section 3.”  What additional research is necessary to qualify this surface coating (or similar products) for registration under Section 3 of FIFRA?  Will registration occur on an accelerated timeline, or will EPA continue granting emergency exemptions until the standard registration process is completed?  EPA has indicated that it will provide information on at least some of these issues “in the coming weeks.”

What about treated articles?  This emergency exemption addresses only a surface coating that is designed to be regularly re-applied.  To date, EPA has not addressed what efficacy data might be required for articles treated with antiviral products that are designed to last for months or even years.  Will EPA develop an approach for evaluating and registering such products?  EPA’s Science Advisory Board found in June that such products could “have high potential in reducing or eliminating exposure to SARS-CoV-2,” and thus should be a “high priority area to investigate.”