Instructions for Adding Electrostatic Spray Application Directions for Use to Antimicrobial Product Registrations

EPA previously announced that it would expedite review for the addition of the electrostatic spray method of application for currently registered or new product registrations that are on EPA’s Disinfectant List N or would qualify for List N.

As of April, 2021, EPA is no longer expediting review of these actions. 

Under PRIA, typical decision review timeframes for these types of registration actions range from four months for amendments that do not require data review for risk assessment to nine months for amendments or new product submissions requiring data review for risk assessment.

Recently, there has been increased interest in the application of antimicrobial disinfectants on List N via electrostatic spray given the need to disinfect large indoor spaces to reduce the risk of exposure to the virus that causes COVID-19. Electrostatic sprayers work by charging the antimicrobial liquid as it passes through a nozzle. The positively charged antimicrobial droplets are attracted to negatively charged environmental surfaces allowing for improved coverage on hard, non-porous environmental surfaces. 

1. Requests to amend currently registered products (including those disinfectants identified on List N) that require the review of data under PRIA:

A. Current EPA-registered products approved for application via spray and already on List N:

Submission of new efficacy data to add claims to an already EPA-registered product can be submitted as a PRIA A570 action. EPA will consider applications for amended registration to add electrostatic spray directions for use if:

• The product is already on EPA’s List N
  AND
• The product labeling is already approved for application via spray
  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 application via electrostatic spray:
    • Disinfectant efficacy data against Staphylococcus aureus and either Pseudomonas aeruginosa or Salmonella enterica consistent with the 810.2200 Disinfectants for Use on Environmental Surfaces, Guide for Efficacy Testing (2018) AND virucidal efficacy data against the hardest to kill virus (see the emerging viral pathogens guidance for information on hierarchy of viruses).
    • Due to lab capacity concerns, non-GLP (Good Laboratory Practice) data will be considered to support electrostatic spray submissions, provided that the study submission accurately represents how the study differs from the GLP standards in the 40 CFR 160.12 statement of non-compliance.
  • A wetness test consistent with Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridioides difficile on Hard Non-Porous Surfaces and a video to demonstrate that the surface remains wet for the duration of the contact time.
  • The following amendments to the product label should accompany 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 directions for use:
    • For chemicals that have low vapor pressures (less than 1. X 10^-4 mm Hg), use N95 filtering facepiece 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 personal protective equipment including gloves, clothing and eye protection is applicable as specified on the approved product label consistent with the acute toxicity profile of the product.

To ensure the efficient processing of your PRIA submission, please include the following in a cover letter to EPA:

• A subject line that clearly indicates “Existing Product Submission of Data to Add Electrostatic Spray Directions for Use for Product on List N;”
• A list of the submitted efficacy data supporting electrostatic spray application;
• The identification of the organism(s) and study ID number(s) (MRID/s) for which review is being requested.

The following should also be included with your PRIA submission:

• An up-to-date Certification w/ Respect to Data Citation Form (Form 8570-34) and Data Matrix (Form 8570-35);
• CSF(s) (Form 8570-4);
• An 8570-1 application form;
• A revised master label, both a highlighted version and a clean version, with the updated directions for use and the considerations for electrostatic spray including PPE identified above; and
• A PRIA fee payment, in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA A570 action.

Submit your application via the CDX portal.

For questions about what is needed as part of your submission, please contact the Product Manager for your product.

B. Currently EPA-registered products approved for application via spray for inclusion on List N:

For a request to amend a currently EPA-registered product for inclusion on List N and specify electrostatic spray as an approved method of application, follow the directions in EPA’s previously announced review of certain PRIA submissions for products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19. 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 in Section 1A for electrostatic spray as part of your submission. Submission of new efficacy data to add claims to an already EPA-registered product along with the information specified for electrostatic spay can be submitted together as a PRIA A570 action. The submission should include a PRIA fee payment in the amount of $4,023, or small business fee waiver request with the appropriate fee for a PRIA A570 action. 

Submit your application via the CDX portal. 

C. Currently EPA-registered products not approved for application via spray 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 application via spray and/or the registrant wants to conduct and submit data to modify the default PPE label language specified in the above section, these data should be submitted as a PRIA code A572 and include the efficacy data, directions for use for electrostatic spray, and other documents specified above in Section 1A.

In addition, include the receipt of a PRIA fee payment 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 A540 action or PRIA A572 action.

Submit your application via the CDX portal. 

2. Requests to add electrostatic spray directions for use to a new product that requires the review of data under PRIA:

A. 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 spray, and (3) a registered source of active ingredient, follow the instructions in EPA’s previously announced review of certain PRIA submissions for products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19. 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 in Section 1A for electrostatic spray. As specified in the PRIA guidance, this is a PRIA A540 action, and the submission should include a PRIA fee payment in the amount of $5,363, or small business fee waiver request with appropriate fee for a PRIA A540 action.

Submit your application via the CDX portal. 

B. 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 spray, and (3) an unregistered source of active ingredient, follow the instructions in EPA’s previously announced review of certain PRIA submissions for products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19. 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 in Section 1A for electrostatic spray. As specified in the PRIA guidance, this may be either a PRIA A540 action or a PRIA A572 action. The submission should include a PRIA fee payment in the amount of $5,363, or small business fee waiver request with appropriate fee for a PRIA A540 action or $13,888 for an A572 action, or small business fee waiver request with the appropriate fee for a PRIA A572 action.

Submit your application via the CDX portal.

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¹ In EPA’s ‘Standard Operating Procedures for Residential Pesticide Exposure Assessment’ (2012) (https://www.epa.gov/sites/production/files/2015-08/documents/usepa-opp-hed_residential_sops_oct2012.pdf) foggers are defined as having a droplet size of 15 – 60 µm. This definition is for total-release foggers that have a wider droplet size distribution than electrostatic sprayers. According to the WHO Guidance on ‘Space Spray Application of Insecticides for Vector and Public Health Pest Control’ (2003) (https://apps.who.int/iris/handle/10665/68057), it is generally accepted that droplets should be generated at 10-30 μm so that, even with some evaporation and after some time, they remain in the correct range for optimal airborne suspension and insect impact. An electrostatic sprayer that has a droplet size of ≥40 µm volume median diameter would not be considered a fogger.