On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.
EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2. These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2. This process does not replace the review process of all other submitted antimicrobial products.
EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).
The following submissions may qualify for expedited review:
Amendments for Currently Registered Products
-
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 (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
-
A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.
New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.
-
A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
-
A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).
Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here.
EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.
For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2. EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs. Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.