Key Takeaways:

• What Happened: EPA announced an expansion of its expedited review process to now include new antimicrobial pesticide product applications and amendments requiring data review.
• Who’s Impacted: Manufacturers and distributors of disinfectant products that are potentially effective against the novel coronavirus.
• What Should They Consider Doing in Response: Evaluate disinfectant product eligibility under EPA’s expanded procedures for expedited data review.

Manufacturers of antimicrobial pesticides may now be able to more quickly obtain U.S. Environmental Protection Agency (EPA) approval and inclusion on EPA’s List N of disinfectants effective against the novel coronavirus, SARS-CoV-2, thanks to a new expedited review process.

Earlier this year, EPA announced the availability of expedited review intended for registered disinfectants that do not require any review of new efficacy data. To date, EPA has approved “emerging viral pathogen designations” for over 400 antimicrobial products for distribution and use against the novel coronavirus. Under the newly announced process, EPA is now expediting decision timelines for registered disinfectants that require data review to demonstrate efficacy against SARS-CoV-2, as well as registration applications for new, currently unregistered disinfectants.

Pesticide Registration and Registration Amendments

Disinfectants, sanitizers, and other substances intended for use on objects and surfaces against microorganisms are considered antimicrobial pesticides and cannot be sold or distributed unless they are first registered by EPA under the Federal Fungicide, Insecticide, and Rodenticide Act (FIFRA). EPA considers antimicrobial pesticides intended to control microorganisms that pose a threat to human health to be “public health” products, and any claims for use against a specific public health pathogen must be supported by efficacy data reviewed by EPA. If a particular pesticide is already registered and its producer would like to add antimicrobial claims to its label, the producer must submit a registration amendment application and, as for an initial registration application, support those new claims with efficacy data.

The pesticide registration timeline is governed by the Pesticide Registration Improvement Extension Act of 2018 (PRIA). Under PRIA, decision review timeframes for the antimicrobial product types addressed by the new policy normally range from 4 months (for certain new products or registration amendments requiring no data review) to 24 months (for applications involving certain new active ingredient submissions). For estimates of estimated PRIA action review times generally, see the EPA Antimicrobials Division’s PRIA Action Code Tables.

Expedited Review for Potential List N Products

According to its new announcement, EPA now aims to reduce its decision review times by one to two months for PRIA submissions associated with disinfectant products that require data review, if they are potentially effective against SARS-CoV-2. The Agency hopes to further reduce average review times as it gains experience with these expedited procedures.

The following requests to amend currently registered products are now eligible for expedited review:

• A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
• A request to add a new unregistered source of a non-commodity active ingredient to a product’s confidential statement of formula (please see our recent news alert to learn more about “commodity” and “non-commodity” active ingredients); and
• A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data.

Under the expedited review policy, EPA now estimates response times for such requests of only two or three months for potential List N products.

EPA also intends to expedite registration application approvals for certain new pesticide products with virucidal claims. Such applications may be associated with new hospital or broad-spectrum surface disinfectants formulated with either a registered or unregistered source of active ingredient(s), as well as new active ingredients or new uses for currently registered active ingredients. Data review for these applications usually takes between 5 and 24 months, depending on the scope of EPA review required. EPA now intends to reduce these review periods by at least one to two months for all submissions associated with potential List N products.

EPA’s announcement provides detailed guidance as to the kinds of efficacy data required to be submitted for each eligible PRIA application or request, as well as formatting and submission instructions. However, the Agency emphasizes that no data or technical requirements have been changed, and that deficient applications may be rejected.

In light of EPA’s new process, pesticide registrants, manufacturers, and other stakeholders should evaluate eligibility of all products with potential effectiveness against the novel coronavirus and, if appropriate, seek expedited review and inclusion of those products on EPA’s List N of disinfectants for use against SARS-CoV-2.