On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against the SARS-CoV-2, the virus that causes COVID-19.  This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product labels.  The Guidance outlines information that EPA asks registrants to submit to obtain expedited review of their proposed addition of this application method to their labels.

EPA notes that electrostatic spraying has drawn increased interest through the current public health emergency posed by COVID-19 because of the need to disinfect large indoor spaces, such as schools, offices, businesses, and other large areas, or areas with many surfaces.  Unlike conventional spraying methods, electrostatic sprayers apply a positive charge to liquid disinfectants as they pass through the nozzle.  The positively charged disinfectant is attracted to negatively charged surfaces, which allows for efficient coating of hard nonporous surfaces.

EPA’s Guidance addresses adding electrostatic spray application methods to both new and currently registered disinfectant products that are on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or that would qualify for List N, and require review under the Pesticide Registration Improvement Extension Act (PRIA 4). 

EPA states that it will expedite the following registration applications:

• Requests to amend currently registered products, including products listed on List N, that require review of data under PRIA 4:

  • Current EPA-registered products approved for spray use application methods, already on List N, and the application is supported by the following data and revised label language: 

    • Confirmatory efficacy data conducted with an electrostatic sprayer to bridge from the existing approved claims to applications by electrostatic sprayers;

    • A wetness test consistent with MLB SOP MB-31 and a video to demonstrate that the surface remains wet for the duration of the contact time; and

    • The following amendments made to the product label for electrostatic spray use directions:

      • Spray droplet particle size (regardless of the ability to change nozzles that impact particle size) should be limited to a volume median diameter (VMD) ≥40 µm¹.

      • Include the contact time and minimum and maximum spray distance from the application equipment to the treated surface that is supported by the efficacy data, and instructions to reapply if the surface dries before the contact time is achieved.

      • Place the electrostatic spray function in the ON position for electrostatic spray models that have the functionality to toggle ON/OFF.

      • Specify that bystanders and pets must not be in the room during application.

    • The following personal protective equipment (PPE) should be specified on the product label as part of the electrostatic spray use directions:

      • For chemicals that have low vapor pressures (less than 1. X 10-4 mm Hg), use N95 filtering face piece respirators or half face respirators with N95 filters.

      • For high vapor pressure chemicals (greater than 1. X 10-4 mm Hg), such as hydrogen peroxide, use half face respirators with chemical specific cartridges and N95 filters.

      • Other PPE including gloves, clothing, and eye protection is applicable as specified on the approved product label consistent with the acute toxicity profile of the product.

  • Current EPA-registered products approved for spray use application methods for inclusion on List N:

    • For a request to amend currently registered products for inclusion on List N and to specify electrostatic spray as an approved method of application, follow the directions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against the SARS-CoV-2. Specifically, follow the directions in the “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)” section and include the additional information specified above for electrostatic sprayers as part of the submission. Submission of new efficacy data to add claims to an already EPA-registered product along with the information specified for electrostatic sprayers can be submitted together as a PRIA 4 A570 action for expected expedited review.

    • The submission should include a PRIA 4 fee payment in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA 4 A570 action. EPA states that it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard four-month timeframe under PRIA 4.

  • Current EPA-registered products not approved for spray use application methods or for which modified PPE label language is desired for inclusion on List N:

    • If the currently registered product labeling for the active ingredient is not approved for spray use application methods and/or the registrant wants to conduct and submit data to modify the default PPE label language specified above, these data should be submitted as a PRIA 4 code A572 and include the efficacy data, directions for use for electrostatic sprayers, and other documents specified above. EPA states it will make every effort to complete the review and make a regulatory decision one to two months faster than the standard nine-month timeframe under PRIA 4.

    • In addition, include the receipt of a PRIA 4 fee payment in the amount of $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA 4 A540 action or PRIA 4 A572 action.

• Requests to add electrostatic spray use directions to a new product that requires the review of data under PRIA 4:

  • New product formulated with a registered source of active ingredient(s):

    • For submission of an application for a new pesticide product for (1) inclusion on List N, (2) directions for use for electrostatic sprayers, and (3) a registered source of active ingredient, follow the instructions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against the SARS-CoV-2. Specifically, follow the directions for “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 include the additional information specified above for electrostatic sprayers.

    • As specified in the expedited PRIA 4 guidance, this is a PRIA 4 A540 action, and the submission should include a PRIA 4 fee payment in the amount of $5,363, or small business fee waiver request with appropriate fee for a PRIA 4 A540 action.

  • New product formulated with an unregistered source of active ingredient(s):

    • For submission of an application for a new pesticide product for (1) inclusion on List N, (2) directions for use for electrostatic sprayers, and (3) an unregistered source of active ingredient, follow the instructions in EPA’s previously announced expedited review of certain PRIA 4 submissions for products intended for use against the SARS-CoV-2. Specifically, follow the directions for “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 active ingredient(s)” and include the additional information specified above for electrostatic sprayers.  

    • As specified in the expedited PRIA 4 guidance, this may be either a PRIA 4 A540 action or a PRIA 4 A572 action. The submission should include a PRIA 4 fee payment in the amount of $5,363, or small business fee waiver request with appropriate fee for a PRIA 4 A540 action or $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA 4 A572 action.

EPA’s Guidance builds on EPA’s previously announced expedited review of certain submissions for products intended for use against SARS-CoV-2.

This guidance is important for many disinfectant products.  Affected registrants or potential registrants should review it carefully.