Instructions for Review of Pesticide Registration Improvement Act (PRIA) Submissions for Products Eligible for Inclusion on List N: Submission Information for Registrants

EPA previously announced the expedited review of certain Pesticide Registration Improvement Act (PRIA) submissions for products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19. 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 EPA’s Disinfectant List N for use against SARS-CoV-2.

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

Under PRIA, decision review timeframes for these types of registration actions range from four months for amendments and new products to 24 months for new active ingredient submissions (AD PRIA Action Code Tables). For inclusion on List N, the following PRIA submissions may be submitted:

1. Requests to amend currently registered products that require the review of data under the PRIA code A570 (four months standard review timeframe):

   1. 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).
   2. A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in Temporary Amendment to PR Notice 98-10) to a product’s confidential statement of formula (CSF).
   3. 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.

2. Applications to register new pesticide products under PRIA codes A540 and A572 (five months to nine months standard review timeframe, respectively):

   1. 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).
   2. 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 active ingredient(s).

In order to ensure an efficient review process, please review the following information on antimicrobial pesticide registrations to ensure that all requirements are addressed with the relevant PRIA submission. All application packages will be subject to content and technical screens as required under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) and may be subject to rejection if deficiencies cannot be corrected. For more information, see Pesticide Registration Improvement Extension Act of 2018 (PRIA 4).

1. Request to Amend Currently Registered Products

a. 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).

Submission of new efficacy data to add claims to an already EPA-registered product can be submitted as a PRIA A570. To ensure efficient review:

1. If the currently registered product labeling is approved only for sanitizer claims or the labeling is approved with no public health claims, the following data should be submitted for EPA to consider approving virucidal claims:

   • Efficacy data to support a base disinfection claim is needed before claims for viruses can be made (e.g., Staphylococcus aureus and Pseudomonas aeruginosa, see OCSPP 810.2200 for details); AND
   • Virucidal efficacy data for a SARS-CoV-2 claim or other human coronavirus (e.g., ATCC 229E) claim; OR

2. Efficacy data for a non-enveloped virus to support an emerging viral pathogen claim (see the Emerging Viral Pathogens Guidance for examples of qualifying viruses).B. If the currently registered product labeling is approved for a broad spectrum or hospital disinfection claim, the following data should be submitted for EPA to consider approving virucidal claims:

   • Virucidal efficacy data for a SARS-CoV-2 claim or other human coronavirus (e.g., ATCC 229E) claim; OR
   • Efficacy data for a non-enveloped virus to support an emerging viral pathogen claim (see the Emerging Viral Pathogens Guidance for examples of qualifying viruses).

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 Efficacy Data to Qualify for List N;”
• A list of the submitted efficacy data;
• The identification of the virus(es) from the submitted data that support the emerging viral pathogen claim(s), SARS-CoV-2 claim(s) or other human coronavirus claim(s); and
• The identification of the organism(s) and study ID number(s) (MRID/s) for which review is being requested.

The following are also required to 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);
• An 8570-1 application form;
• A revised master label, both a highlighted version and a clean version, with the claim(s) for virus(es) specified in the efficacy data, updated directions for use, contact time, and emergent pathogen claims if applicable; and
• The receipt of 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.

If a request to add an emerging viral pathogen claim is being made, please refer to the instructions for adding these claims.

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. 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 CSF.

View the May 11, 2020, Temporary Amendment to PR Notice 98-10.

• A submission for this type of amendment will be considered a PRIA A570 action, provided that the generic data requirements are satisfied by a “cite-all” data citation. The standard PRIA timeframe for this action when approving an amendment unconditionally is four months.
• If selective data citation is used to address the generic data requirements, then the request will be a PRIA A572 action (see the Pesticide Registration Manual: Chapter 10 - Data Compensation Requirements for more information on data compensation).

For efficient review, ensure that:

• The pesticide product is currently listed on EPA’s List N: Disinfectants for Use Against SARS-CoV-2, or serves as the source of active ingredient for products on List N.
• Any generic data requirements are satisfied using the “cite-all” option.
• Any inert ingredient change to the product’s CSF is limited only to water adjustments and those described in Section IV of the Temporary Amendment to PR Notice 98-10.
• Per 40 CFR §161.170, submission of preliminary analysis data (OPPTS Guideline 830.1700) are required. However, EPA will accept a certification that the purity of the new source is accurate and that it contains no impurities of toxicological significance. With this certification, the new CSF will be conditionally approved. If the preliminary analysis data are not submitted with the application, the amendment approval letter will require the data to be submitted within six months of the conditional approval. If the preliminary analysis data are submitted with the application, the approval letter will note that a review of the data will be provided at a later date.

To ensure the efficient processing of your PRIA submission, please submit the following:

• A cover letter with a subject line that clearly indicates “Addition of Unregistered Source of Active Ingredient to [insert product name], EPA Reg. No. XXXX, for List N”;
• Updated CSF (8540-4) with the unregistered source of active ingredient listed;

• The following certification statement:

  • "[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient in the formulation of EPA Registration No. [xxx-xx, etc.]. Each source has been found not to contain any unreported impurities of potential toxicological concern. Additionally, each source has been found to meet stated claims for active ingredient purity. This change in source will not adversely affect the efficacy of the product. Further, I confirm that the ingredients statement of this label remains truthful. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this self-certification is not consistent with 40 CFR §152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under sections 12 and 14 of FIFRA."
• Two up-to-date Certifications w/ Respect to Data Citation Forms (Form 8570-34) (one designated as product specific and the other generic);
• Two Data Matrices Forms (Form 8570-35) (one designated as product specific and the other generic);
• An 8570-1 application form; and
• The PRIA A570 action fee payment, in the amount of $4,023, or small business fee waiver request with appropriate fee for a PRIA A570 action.

​Submit your application via the CDX portal.

c. 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.

When public health antimicrobial product formulations are modified by adding/deleting an inert ingredient or adjusting the inert ingredient’s certified limits, confirmatory efficacy data may be needed to validate that these changes do not impact the product’s ability to mitigate the organisms cited on the label. First, follow these steps to determine if the proposed formulation changes need confirmatory efficacy data:

Step 1: The following specific formulation changes do not need confirmatory efficacy data as identified in section B(7) of the 810.2000 Guideline and in the companion 810 efficacy FAQ.

• Only the concentration of a fragrance or dye is increased, substituted, or decreased in a formulation, and
• the concentration of fragrances does not exceed 1.0% (w/w) of the total formulation, or
• the total percentage of changes in dyes does not exceed 1.0% (w/w) of the total formulation, or
• the total percentage of changes in fragrances and/or dyes are less than or equal to 1.0% (w/w) of the total formulation.

You may submit these formulation changes that do not require confirmatory efficacy data in accordance with PR Notice 98-10: Notifications, Non-Notifications, and Minor Formulation Amendments.

Step 2: For all other formulation changes that do not meet the criteria listed in Step 1, please contact the Product Manager to determine if confirmatory efficacy data are required. 

If EPA determines that the formulation amendment change requires confirmatory efficacy data, then the submission must be submitted as a PRIA A570 action. 

For efficient review, ensure that:

• The submission is for a currently registered disinfectant product on EPA’s List N: Disinfectants for Use Against SARS-CoV-2.

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

• A subject line that clearly indicates “Formulation Change Amendment with Confirmatory Efficacy Data for List N”; and
• A list of the submitted efficacy data.

The following are also required:

• An up-to-date Certification w/ Respect to Data Citation Form (Form 8570-34) and Data Matrix (Form 8570-35);
• An 8570-1 application form; and
• The PRIA A-570 action fee payment, in the amount of $4,023, or small business fee waiver request with appropriate fee for a PRIA A570 action.

Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email disinfectantslist@epa.gov with your CDX tracking number (CDX_2020_XXXXXXX) with the subject line “Formulation Change Amendment with Confirmatory Efficacy Data” so that your submission can be eligible to be expedited. If an application does not meet the criteria for expedited review, it will be subject to normal PRIA review timeframes as appropriate.

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

2. New Products

The scenarios below apply to currently registered active ingredients that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.

a. 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).

A submission request for a new hospital or broad-spectrum surface disinfectant product registration that meets the criteria for List N and uses a registered source of active ingredient is a PRIA A540 action. Please review the A540 submission checklist and ensure that the product chemistry, acute toxicology and appropriate efficacy guidelines are all addressed. For more information see all data requirements for pesticide registrations.

For efficient review, ensure that:

• Efficacy data qualifies the product as a broad-spectrum or hospital hard surface disinfectant and includes virucidal efficacy data for SARS-CoV-2 or another human coronavirus (e.g., ATCC 229E) or a non-enveloped virus as outlined in Section 1 above.
• The active ingredient is in other registered products with the same use pattern(s) as those on the proposed product label. If your product is proposing a new application method such as fogging, electrostatic sprayers, or drone technology, it may be considered a new use and EPA may consider expediting the review. You should contact the Product Manager for your active ingredient and/or product.
• The active ingredient is from a registered source.
• All the inert ingredients listed on the CSF are cleared for use in pesticide formulations. For more information see Inert Ingredients Overview and Guidance.

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

• A subject line that clearly indicates “New Disinfectant Product for Inclusion on List N-Registered Source of Active Ingredient;”
• A list of the submitted product chemistry, acute toxicology, and efficacy data;
• The identification of the virus(es) from the submitted data that support the emerging viral pathogen claims or SARS-CoV-2 claim or other human coronavirus claims; and
• The identification of the organisms and study ID number(s) (MRID/s) for which review is being requested.

The following are also required:

• CSF(s) (Form 8570-4);
• Formulator’s Exemption Form (8570-27);
• Certification w/ Respect to Data Citation Form (Form 8570-34) and Data Matrix (Form 8570-35);
• An 8570-1 application form;
• If a request to add an emerging viral pathogen claim is being made, please refer to the instructions for adding these claims.
• A master label with claims against the microorganisms specified in the efficacy data; and
• The PRIA A540 action 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.

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

b. 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 active ingredient(s).

EPA will also review applications for new broad spectrum or hospital disinfectant products that meet the criteria for List N claims with an unregistered source of active ingredient, where the generic data requirements are addressed using the “cite-all” data citation method. A request for this type of submission is a PRIA A540 action. Please review the A540 submission checklist and ensure that the product chemistry, acute toxicology and appropriate efficacy guidelines are all addressed. For more information see all data requirements for pesticide registrations. If selective data citation is used to address the generic data requirements, then the request will be a PRIA A572 action (see the Pesticide Registration Manual: Chapter 10 - Data Compensation Requirements for more information on data compensation). 

To ensure efficient review:

• Submit efficacy data showing that the product qualifies as a broad-spectrum or hospital disinfectant and include virucidal efficacy data for SARS-CoV-2 or another human coronavirus (e.g., ATCC 229E) or non-enveloped virus as outlined in Section 1 above.
• The active ingredient is already registered for the use pattern(s) on the proposed label. If you are proposing a new application method such as fogging, electrostatic sprayers, or drone technology, it may be considered a new use and EPA may consider expediting the review. You should contact the Product Manager assigned to your active ingredient and/or product.
• All the inert ingredients listed on the CSF are approved for use in pesticide formulations. For more information see Inert Ingredients Overview and Guidance.

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

• A subject line that clearly indicates “New Disinfectant for List N-Unregistered Source of Active Ingredient;”
• A list of the submitted product chemistry, acute toxicology, and efficacy data;
• The identification of the virus(es) from the submitted data that support the emerging viral pathogen claims or human coronavirus claim; and
• The identification of the organisms and study ID number(s) (MRID/s) for which review is being requested.

The following are also required:

• CSF(s) (Form 8570-4);
• 2 Certification w/ Respect to Data Citation Forms (Form 8570-34) (One designated as product specific and the other generic);
• 2 Data matrices (Form 8570-35) (one should address the product specific data requirements and the other should address the generic data requirements in support of the unregistered source active ingredient);
• An 8570-1 application form;
• If a request to add an emerging viral pathogen claim is being made, please refer to the instructions for adding these claims.
• A master label with claims against the microorganisms specified in the efficacy data; and
• The PRIA fee payment in the amount of $5,363 for a A540 action or $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.

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