Guidance for Products Adding Residual Efficacy Claims

Throughout the COVID-19 pandemic, the agency received requests from stakeholders regarding a public health need for products with residual efficacy (ongoing antimicrobial effect beyond the initial time of application, ranging from days to weeks to months). Currently, most EPA-registered liquid-based antimicrobial products, including those on EPA’s list of disinfectants effective against SARS-CoV-2, are intended to treat hard, non-porous surfaces at the time of application, but have not demonstrated efficacy beyond the time of application. There is significant interest from stakeholders and the public for products that are continuously active and can provide efficacy between regular cleaning and disinfection. These products may reduce the level of re-contamination on high touch surfaces. This guidance provides registrants with an efficacy testing approach to support these claims.

In October 2020, EPA issued interim guidance and test methods for public comment as a pathway for companies to add claims of residual efficacy to their products’ labels. Revisions to the guidance document and the associated methods were made based on data from EPA laboratory studies and information submitted through public comments. The revised test methods and guidance are available at docket EPA-HQ-OPP-2020-0529 at regulations.gov and on EPA's Microbiology Laboratory Antimicrobial Testing Methods and Procedures webpage. EPA plans to incorporate this guidance into the relevant Series 810 Product Performance Test Guideline in a future update.

Products with residual efficacy claims fall into two major categories: (1) disinfectants that also provide residual efficacy, and (2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard disinfection practices including List N disinfectants. 

Note that depending on their intended use, some antimicrobial products may be subject to both EPA and FDA1 jurisdiction. 

See Table 1 below for a summary of key attributes for these two different types of residual claims. 

Table 1: Summary of Residual Claim Categories

  Claim
 
Residual Disinfectants		 Supplemental Residual Antimicrobial Products
Coatings & Films Fixed (solid & paints)
Meets EPA’s standard for disinfection efficacy Yes No No
Duration of residual claim 24 hours Weeks (product efficacy determines duration) Years
Durability assessment Abrasion Abrasion & Chemical Abrasion & Chemical
Performance standard for bacteria for residual claim 5-log reduction 3-log reduction 3-log reduction
Performance standard for viruses* for residual claim 3-log-reductions 3-log reduction 3-log reduction
Time to meet performance standard ≤ 10 minutes 1-2 hours 1-2 hours

* Claims for viruses should only be added if the product has also met the performance standard for bacteria. This is described in further detail below. 

A full description of these two types of claims and the efficacy testing to support these claims is included below. If an applicant intends to make modifications to the residual test methods or claims that are beyond the scope of this guidance, applicants are highly encouraged to submit a PRIA protocol review (A520/521) and consult with EPA prior to submitting efficacy data. In addition, it is recommended that applicants review the Guidance for Pre-Application Meetings on New Active Ingredients, Major New Uses and Other Registration Actions. Note that products may make residual disinfectant claims and supplemental residual antimicrobial coating/film claims provided they are supported by the appropriate data. Note the current guidance does not address claims against mycobacterium, fungi, yeasts, or bacterial endospores. Further, the guidance is limited to products used on hard, non-porous, non-food contact surfaces and does not address products used on textile (e.g., porous) surfaces. 

On this page:

I. Residual Disinfectant Claims

A. Qualifying liquid formulations or spray products should satisfy all efficacy requirements for standard disinfectant claims (non-residual) and should have undergone testing to support standard disinfectant claims to be eligible for residual disinfectant claims.2

  1. This guidance is not intended to address residual disinfectant products formulated as towelettes. Please consult with EPA to discuss residual products formulated as towelettes. 

B. Residual Bactericidal Disinfectant Claims

  1. To support a claim as a residual bactericidal disinfectant, utilize EPA’s Interim Residual Self-Sanitization Protocol with modifications listed below.
  2. Base Bacteria—Consistent with EPA Guideline 810.2200, Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) should be used to support the residual bactericidal disinfectant claim. See Table 2.
  3. Test Surfaces (carriers): One “set” of surfaces is made up of two 1” × 1” carriers; two sets (4 carriers) are required.
  4. Conduct testing on 2 product lots at the lower certified limit (LCL) for each bacterium. In accordance with the OCSPP 810.2200 Test Guideline, certificates of analysis should be submitted to substantiate the tested concentration.
  5. Residual bactericidal disinfectant testing to support additional vegetative bacteria is not needed (see Table 2). Claims can be bridged from the standard disinfectant (non-residual data) for additional bacteria. 
    1. For example, if a product has data to support a base disinfectant claim (Staphylococcus aureus and Pseudomonas aeruginosa) and data to support disinfectant claims for additional vegetative bacteria (e.g., E. coli or MRSA), residual bactericidal disinfectant data are only needed for the base bacteria and not the additional vegetative bacteria. 
  6. Per the Interim Residual Self-Sanitization Method, durability testing should include 12 wear cycles consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim. Claims of a longer or shorter duration should be discussed with EPA in advance. Each wear cycle consists of 2 passes (one pass to the left and a return pass to the right) of the abrasion material over the surface followed by re-inoculation. Additional details can be found in the method.
  7.  Products should achieve a ≥ 5-log reduction in ≤10 minutes ± 5 seconds for qualifying bacteria when compared to the parallel abrasion and re-inoculation controls to support residual bactericidal disinfectant claims.
    1. Per the OCSPP 810.2200 Test Guideline, the performance standard and time to meet the performance standard are consistent with the standards for non-residual disinfectants. 

C. Residual Virucidal Disinfectant Claims

  1. Utilize EPA’s Interim Residual Self-Sanitization Protocol with the appropriate documented modifications for viruses to support residual virucidal disinfectant claims. Virucidal recovery and cytotoxicity assessments should be consistent with the principles of ASTM E1053; the standard virucidal method detailed in OCSPP 810.2200 Product Performance Test Guideline.
    1. Calculations should be conducted consistent with the EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings (EPA MLB SOP MB-40) to calculate the TCID50/carrier or “most probable number” (MPN)/carrier.
  2. To support residual virucidal disinfectant claims, acceptable non-residual virucidal efficacy (3-log reduction) should be demonstrated for the product at ≤10-minute contact time consistent with the OCSPP 810.2200 Product Performance Test Guideline.
  3. Residual virucidal disinfectant data should be generated for the most difficult to kill virus that the product claims to kill. Claims for residual virucidal disinfectant efficacy against the other viruses can be bridged from the non-residual virucidal data supporting the product. For additional information on selecting the most difficult to kill virus, see EPA’s Emerging Viral Pathogens Guidance.
  4. Conduct testing on 2 product lots at the LCL.
  5. Per the Interim Residual Self-Sanitization Method, durability testing should include 12 wear cycles consisting of abrasions (alternating wet and dry) and re-inoculations to support a 24-hour residual disinfectant claim. Each wear cycle consists of 2 passes (one pass to the left and a return pass to the right) of the abrasion material over the surface followed by re-inoculation. Additional details can be found in the method.
  6. Products should achieve ≥ 3-log reduction in ≤10 minutes ± 5 seconds for the hardest to kill virus when compared to the parallel abrasion and re-inoculation controls to support residual virucidal disinfectant claims.
    1. Per the OCSPP 810.2200 Product Performance Test Guideline, the performance standard and time to meet the performance standard are consistent with the standards for non-residual disinfectants. 

D. Residual Disinfectant Claims – Labeling and Additional Information

  1. Products are eligible for inclusion on List Q: Disinfectants for Emerging Viral Pathogens following adherence to the Emerging Viral Pathogens guidance.
  2. These products can be used as stand-alone disinfectants and do not need a label disclaimer that they are a “supplement to standard disinfection” since they meet the general criteria for disinfectants (effective in ≤10 minutes with appropriate log reductions for bacteria and viruses).

Table 2: Summary of Testing for Residual Disinfectant Claims

Claim Test Method Test Organisms No. of Lots
Residual Disinfectant Base Bacteria Interim Residual Self-Sanitizer Method
 		 Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) 2 lots per organism at the LCL
Additional Vegetative Bacteria Bridged from non-residual disinfectant data  Vegetative bacteria claimed on the label N/A
Virucidal Modified Interim Residual Self-Sanitizer Method and ASTM E1053 to assess viral recovery Hardest to kill virus claimed on the label  2 lots at the LCL
Other viruses claimed on the label  Bridged from non-residual virucidal data

II. Supplemental Residual Antimicrobial Products

A. Data for supplemental residual antimicrobial surface coatings, films, fixed/solid and paint products demonstrating efficacy against the base vegetative bacteria should be submitted prior to or concurrently with data for supplemental residual antimicrobial surface coatings, films, fixed/solid and paint products demonstrating efficacy against viruses. These products are not required to meet the efficacy standards for stand-alone disinfectants or sanitizers – EPA intends to approve these products for use as supplements to standard disinfection.

B. Antimicrobial Surface Coatings and Films. 

  1. To support a claim for a supplemental residual antimicrobial surface coating or film, utilize EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings for bacteria and viruses (EPA MLB SOP MB-40).
  2. Test Organisms
    1. Base Bacteria—Consistent with EPA Guideline 810.2200, Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) should be used to support supplemental residual antimicrobial surface claims for the proposed claim duration. See Table 3.
      1. Conduct testing on 2 product lots at the lower certified limit (LCL) for each bacterium. In accordance with the OCSPP 810.2200 Product Performance Test Guideline, certificates of analysis should be submitted to substantiate the tested concentration. 
    2. To support supplemental residual antimicrobial surface coating claims for additional bacteria, testing should be conducted according to the method but using test carriers that were not subjected to the durability procedure. See Table 3.
      1. Conduct testing on 2 product lots at the nominal concentration for each bacterium.
    3. Viruses—All viruses for which claims are desired should be tested. The most difficult to kill virus should be subjected to the durability assessment using coated carriers followed by the efficacy assessment to support the proposed duration (see Table 3). All other viruses should be subjected to the efficacy assessment using coated carriers not subjected to the durability assessment.
      1. Conduct testing on 2 product lots at the LCL for the most difficult to kill virus. 
      2. Conduct testing on 2 product lots at the nominal concentration for additional viruses.
  3. Stainless steel carriers should be used to support claims for coatings or films on hard, non-porous surfaces. Use-sites should be limited to hard, non-porous surfaces. This method is not suitable for porous materials (e.g., textiles). A claim for these types of materials may be proposed by the registrant upon consultation with EPA prior to submission and will require a protocol submission and/or agency protocol review separate from the current method for hard surfaces, the subject of this guidance.
  4. The number of chemical exposure and abrasion processes provided in the method substantiate a 1-week supplemental residual antimicrobial claim. The method specifies three active ingredients (e.g., chemical disinfecting solutions) to be used to simulate cycles of in-service disinfection and cleaning. Additional details can be found in the method.
    1. Incompatibility of a proposed antimicrobial surface coating or film with one or more of the specified active ingredients should be discussed with EPA in advance of testing; incompatibility may limit use-sites and surfaces. EPA does not have a standard method for determining incompatibility; determination of incompatibility may be based on research and development data or on previously reported incompatibilities.
  5. Testing for claims of a longer duration should be discussed with EPA in advance.
  6. Products should achieve a 99.9% reduction (3-log) for both bacteria and virus/es in comparison to untreated controls within a 1–2-hour contact time.
    1. The contact time begins at the time of inoculation.
    2. Note: the minimum contact time is 1 hour; contact times less than 1 hour may result in inoculum that has not dried on the surface of carriers and therefore may not provide an accurate assessment of the product.

C. Antimicrobial Surface Coatings and Films – Labeling and Additional Information

  1. This category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces.
  2. EPA does not consider products meeting only the efficacy criteria for a supplemental residual antimicrobial claim to be eligible for an unqualified residual disinfectant claim due to the longer contact time (1-2 hours) and lower performance standard for bacteria (3-log reduction), as compared to residual disinfectants (contact times ≤10 minutes and a ≥ 5-log reduction performance standard).
  3. Products should carry the following prominent label qualifier detailing that the product is a supplement to standard disinfection and cleaning:
    1. “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
  4. For products eligible only for supplemental residual antimicrobial claims, the label and labelling should state “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant”.
  5. Although these products will not be eligible for inclusion on any of the stand-alone disinfectant lists (e.g., List N), they will be eligible for inclusion on a supplement to List N (List N Appendix) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants. 
  6. The following are example acceptable product label claims:
    1.  “Kills 99.9% of [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program/protocol for up to X days.” 
    2. “Continuously reduces [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program for up to X days.”

Table 3: Summary of Testing for Supplemental Residual Surface Coating Claims

Claim Test Method Test Organisms No. of Lots/ Carriers
Supplemental Residual Surface Coating Base Bacteria EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings (EPA MLB SOP MB-40) Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442)

2 lots per organism at the LCL

Carriers should be subjected to durability assessment.
Additional Vegetative Bacteria EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings (EPA MLB SOP MB-40) Vegetative bacteria claimed on the label

2 lots per organism at the nominal concentration.

No durability assessment for the carriers is needed.
Virucidal EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings* (EPA MLB SOP MB-40) Hardest to kill virus claimed on the label 

2 lots at the LCL 

Carriers should be subjected to durability assessment. 
Other viruses claimed on the label 

2 lots at the nominal concentration. 

No durability assessment for the carriers is needed.

* EPA’s Test Method for Evaluating the Efficacy of Antimicrobial Surface Coatings has been revised to include virucidal efficacy testing procedures.

D. Fixed/Solid Surfaces Including Solid Copper, Other Metals, and Solid Impregnated Materials and Paints.

  1. To support a claim for a supplemental residual antimicrobial fixed/solid surface, utilize EPA’s Method for the Evaluation of Antimicrobial Activity of Hard, Non-porous Copper-Containing Surface Products for bacteria and viruses (EPA MLB SOP MB-41) (see Table 4). 
  2. Test Organisms
    1. Base Bacteria—Consistent with EPA Guideline 810.2200, Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442) should be used to support supplemental residual antimicrobial surface claims.
      1.  Conduct testing on 2 product lots at the lower certified limit (LCL) for each bacterium. 
    2. To support supplemental residual antimicrobial fixed/solid surface claims for additional bacteria, testing should be conducted according to the method but using test carriers that were not subjected to the durability procedure. Testing should be conducted on 2 product lots at the nominal concentration (see Table 4).
    3. Viruses—All viruses for which claims are desired should be tested. The most difficult to kill virus should be subjected to the durability assessment using the supplemental residual antimicrobial fixed/solid surface carriers followed by the efficacy assessment (see Table 4). All other viruses should be subjected to the efficacy assessment using the supplemental residual antimicrobial fixed/solid surface carriers not subjected to the durability assessment.
      1.  Conduct testing on 2 product lots at the LCL for the most difficult to kill virus. 
      2. Conduct testing on 2 product lots at the nominal concentration for additional viruses.
  3. The number of abrasions and cycles of exposure to disinfecting chemicals provided in the method substantiate durability claims. The method also specifies three active ingredients (e.g., chemical disinfecting solutions) to be used to simulate cycles of in-service disinfection and cleaning. Additional details can be found in the method.
    1. Incompatibility of a proposed antimicrobial fixed/solid surface with one or more of the specified active ingredients should be discussed with EPA in advance of testing; incompatibility may limit use-sites and surfaces. EPA does not have a standard method for determining incompatibility; determination of incompatibility may be based on research and development data or on previously reported incompatibilities.
  4. As the durability of these types of products can be readily observed, duration claims are not necessary. This is consistent with currently registered copper-containing surface products and paints. 
  5. This protocol can be modified for other metals or solid impregnated surfaces or paints upon consultation with EPA.
  6. Products should achieve a 99.9% reduction (3-log) for both bacteria and virus/es in comparison to untreated controls within a 1–2-hour contact time.
    1. The contact time begins at the time of inoculation.
    2. Note: the minimum contact time is 1 hour; contact times less than 1 hour may result in inoculum that has not dried on the surface of carriers and therefore may not provide an accurate assessment of the product.

E. Fixed/Solid Surfaces Including Solid Copper, Other Metals, and Solid Impregnated Materials and Paints – Labeling and Additional Information

  1. This guidance is not intended to address materials and products formulated with sheens, colorants, glosses, etc. Please consult with EPA to discuss supplemental residual antimicrobial products formulated with additives not addressed in this guidance. 
  2. This category of antimicrobial products should be labeled as supplemental residual antimicrobial surfaces.
  3. EPA does not consider products meeting only the efficacy criteria for a supplemental residual antimicrobial claim to be eligible for an unqualified residual disinfectant claim due to the longer contact time (1-2 hours) and lower performance standard for bacteria (3-log reduction), as compared to residual disinfectants (contact times ≤10 minutes and a ≥ 5-log reduction performance standard). 
  4. Products should carry the following prominent label qualifier that they are a supplement to standard disinfection and cleaning:
    1. “Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)]. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”
  5. For products eligible only for supplemental residual antimicrobial claims, the label and labelling should state “This product does not meet EPA’s efficacy standards to qualify as a stand-alone disinfectant”. 
  6. Although these products will not be eligible for inclusion on any of the stand-alone disinfectant lists (e.g., List N), they will be eligible for inclusion on a supplement to List N (List N Appendix) to reflect that they are supplemental treatments (i.e., not stand-alone disinfectants) and intended for use in combination with List N disinfectants.
  7. The following are example acceptable product label claims:
    1. "Kills 99.9% of [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program/protocol” 
    2. “Continuously reduces [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program”

Table 4: Summary of Testing for Supplemental Residual Surface Coating Claims

Claim Test Method Test Organisms No. of Lots/ Carriers
Supplemental Residual Surfaces (e.g., Solid Copper, Other Metals, and Solid Impregnated Materials and Paints) Base Bacteria EPA’s Method for the Evaluation of Antimicrobial Activity of Hard, Non-porous Copper-Containing Surface Products (EPA MLB SOP MB-41) Staphylococcus aureus (ATCC No. 6538) and Pseudomonas aeruginosa (ATCC No. 15442)

2 lots per organism at the LCL

Carriers should be subjected to durability assessment.
Additional Vegetative Bacteria EPA’s Method for the Evaluation of Antimicrobial Activity of Hard, Non-porous Copper-Containing Surface Products (EPA MLB SOP MB-41) Vegetative bacteria claimed on the label

2 lots per organism at the nominal concentration.

No durability assessment for the carriers is needed.
Virucidal EPA’s Method for the Evaluation of Antimicrobial Activity of Hard, Non-porous Copper-Containing Surface Products* (EPA MLB SOP MB-41) Hardest to kill virus claimed on the label 

2 lots at the LCL 

Carriers should be subjected to durability assessment. 
Other viruses claimed on the label 

2 lots at the nominal concentration. 

No durability assessment for the carriers is needed. 

* EPA’s Method for the Evaluation of Antimicrobial Activity of Hard, Non-porous Copper Containing Surface Products has been revised to include virucidal efficacy testing procedures.

III. Supplemental Residual Antimicrobial Products – Stewardship Program

A. EPA intends to require, as a term of registration, that registrants of all supplemental residual antimicrobial products prepare and implement a written stewardship plan designed to support the responsible use of supplemental residual coatings and antimicrobial surface products. Unlike conventional antimicrobial products, these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices. EPA expects that plans would be submitted for EPA review and approval during the registration process, or shortly thereafter (e.g., within two months after the registration date). An approvable plan would address the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products. 

B. Example Conditions of Registration. The following is an example Condition of Registration that EPA could require to support the proposed claims and use patterns: 

  1. Example Condition: The registrant will prepare and implement a Stewardship Program Plan (Plan) to support the responsible use of antimicrobial surface products. The Plan will be submitted for EPA review and approval within two months after the registration date. If EPA determines at any time after 18 months following registration that the Plan is not being adequately or timely implemented or that implementation of the Plan is not effectively ensuring the proper sale, distribution, or use of antimicrobial surface products, the registration may be canceled by the agency by order with opportunity for a hearing but only after notification to the Registrant and an opportunity to meet with the Director of the Office of Pesticide Programs. The Plan will include, at a minimum, the following elements:
    1. Outreach to the infection control community, including,
      1. Outreach to infection control professionals and other product users with a goal of educating on and reinforcing the proper use of the product. 
      2. Written (including electronic) communications directed to associations of infection control professionals, including at least the Association for Professionals in Infection Control and Epidemiology (APIC), Association for the Health Care Environment (AHE), and any other relevant organizations identified by EPA, and State Departments of Health. 
      3. Outreach communications will be sent within one year after the date of registration, and then at an agreed upon interval thereafter. 
      4. Solicitation of customer feedback consisting of product issues/concerns, adverse events, compliance challenges/observations, and contraindications/adverse events gathered through various channels including but not limited to quarterly registrant-initiated surveys, customer complaints, and suggestion boards.
      5. The content of the outreach communications will include statements explaining the registered claims and applications of antimicrobial coated surfaces, as well as their proper use. Additional content of outreach efforts will be developed as part of the post-registration annual meetings (see section III.B.(c) below).
    2. Development of Website
      1. The website will serve as a resource for conveying accurate information to the public about the efficacy and proper use of the product. 
      2. The website will include information on proper labeling and claims (including advertising); supporting science; applications; maintenance; and federal and state regulations and statutory requirements. 
      3. Frequently Asked Questions (FAQs) section will be incorporated to address common issues or questions raised regarding the product.
      4. The website also serves as a forum to correct any false or misleading third-party statements or publications, including scientific papers, concerning the product. 
      5. The registrant will arrange for and establish links between the website and the websites of appropriate infection control organizations, including but not limited to APIC and AHE.
    3. Participation in post-registration assessment meeting organized by EPA. 
      1. Invited participants will include manufacturers, component makers, and representatives from the infection control community, including appropriate trade associations (e.g., APIC and AHE) and State Departments of Health. 
      2. Meetings may occur as frequently as annually. Attendees may participate either in person or remotely. 
      3. The post-registration assessment meeting will serve as a forum to gather feedback about the use of these products, expand educational efforts, develop outreach communications, and address any questions or concerns from the public and infection control community.

IV. Previously Initiated GLP Efficacy Protocols

A.  All studies initiated on or after October 7, 2023, should be conducted consistent with the 2022 Guidance for Products Adding Residual Efficacy Claims.

B. The study initiation date is defined under 40 CFR Part 160.3 as the date the protocol is signed by the study director. Studies that were initiated prior to the implementation date but submitted to the Agency for review after the implementation date may use either the previous version of the guidance (2020) or the revised (2022) version, as appropriate.

V. How to Prepare an Application for Registration

A. Requests to Amend Currently Registered Products That Require the Review of Data Under PRIA:

  1. Residual Disinfectants
    1. Submission of new efficacy data to add residual disinfectant claims to an already EPA-registered product can be submitted as a PRIA A570 action.
    2. 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 residual virucidal claims:
      1. Efficacy data to support a base (non-residual) disinfection claim (Staphylococcus aureus and Pseudomonas aeruginosa), see OCSPP 810.2200 for details and non-residual virus data for all viruses for which residual claims for viruses are made.
      2. Residual disinfection (Staphylococcus aureus and Pseudomonas aeruginosa) and residual virucidal efficacy data for the hardest to kill virus as described above.
    3. If the currently registered product labeling is approved for broad spectrum or hospital non-residual disinfection and virucidal claims, the following data should be submitted for EPA to consider approving residual virucidal claims:
      1. Residual disinfection (Staphylococcus aureus and Pseudomonas aeruginosa) and residual virucidal efficacy data for the hardest to kill virus as described above.
    4. If the currently registered product labeling is approved for broad spectrum or hospital non-residual disinfection claims with no virucidal claims, the following data should be submitted for EPA to consider approving residual virucidal claims:
      1. Non-residual virus data for all viruses for which residual claims for viruses are being requested. 
      2. Residual disinfection (Staphylococcus aureus and Pseudomonas aeruginosa) and residual virucidal efficacy data for the hardest to kill virus as described above.
    5. To ensure the efficient processing of your PRIA submission, please include the following in a cover letter to EPA:
      1. A subject line that clearly indicates “Existing Product Submission of Efficacy Data for Residual Disinfectant”;
      2.  A list of the submitted efficacy data;
      3. The identification of the virus(es) used in the submitted data that support the emerging viral pathogen claim(s), SARS-CoV-2 claim(s) or other human coronavirus claim(s); and
      4. The identification of all the organism(s) and respective study ID number(s) (MRID/s) for which review is being requested.
    6. The following should also be included with your PRIA submission:
      1. An up-to-date Certification with Respect to Data Citation Form (Form 8570-34) and Data Matrix (Form 8570-35);
      2. CSF(s) (Form 8570-4);
      3. An 8570-1 application form;
      4. A revised master label, both a highlighted version and a clean version, with the updated directions for use for residual disinfection, contact time, and emergent pathogen claims if applicable; and
      5. If a request to add an emerging viral pathogen claim is being made, please refer to the instructions for adding these claims
      6. 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
    7. Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email [email protected] with your CDX tracking number (CDX_XXXX_XXXXXXX).
    8. For questions about what is needed as part of your submission, please contact the Product Manager for your product.
  2. Supplemental Residual Antimicrobial Products (e.g., coatings, paints, solid/fixed surfaces)
    1. Submission of new efficacy data to add supplemental residual antimicrobial claims to an already EPA-registered product can be submitted as a PRIA A570 action. EPA will consider review of applications for amended registration to add supplemental residual antimicrobial claims for use under either of the following circumstances:
      1. For a currently registered product with no approved public health claims, please submit supplemental residual efficacy data relevant to the type of product (e.g., coating vs. solid surface) against base bacteria (Staphylococcus aureus and Pseudomonas aeruginosa) and all viruses for which supplemental residual claims for viruses are made.
      2. For a currently registered product with bacterial public health claims, please submit supplemental residual efficacy data relevant to the type of product (e.g., coating vs. solid surface) against all viruses for which supplemental residual claims for viruses are made.
    2. To ensure the efficient processing of your PRIA submission, please include the following in a cover letter to EPA:
      1. A subject line that clearly indicates “Existing Product Submission of Efficacy Data for Supplemental Residual Antimicrobial Product;”
      2. A list of the submitted efficacy data;
      3. The identification of the virus claim(s) from the submitted data which may include non-enveloped virus(es), SARS-CoV-2(s), or other human coronavirus(es); and 
      4. The identification of the organism(s) and study ID number(s) (MRID/s) for which review is being requested.
    3. The following should also be included with your PRIA submission:
      1.  An up-to-date Certification w/ Respect to Data Citation Form (Form 8570-34) and Data Matrix (Form 8570-35);
      2. CSF(s) (Form 8570-4);
      3. An 8570-1 application form;
      4. A revised master label, both a highlighted version and a clean version, with the updated directions for use; and
      5. 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.
    4. Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email [email protected] with your CDX tracking number (CDX_XXXX_XXXXXXX). 
    5. For questions about what is needed as part of your submission, please contact the Product Manager for your product.

B. Requests for A New Product That Requires the Review of Data Under PRIA

  1. New Product Formulated with A Registered Source of Active Ingredient(s)
    1. For an application for registration of a new pesticide product for residual disinfectant or supplemental residual antimicrobial product intended to be formulated from a registered technical or manufacturing use product, 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 I for residual disinfectants, or provide the information specified above in Section II for supplemental residual antimicrobial products in place of broad-spectrum or hospital hard surface disinfectant data. 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.
    2. Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email [email protected] with your CDX tracking number (CDX_XXXX_XXXXXXX).
  2. New Product Formulated with An Unregistered Source of Active Ingredient(s)
    1. For an application for registration of a new pesticide product for residual disinfectant or supplemental residual antimicrobial product intended to be formulated from an unregistered technical or manufacturing use product, 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 I for residual disinfectants, or provide the information specified above in Section II for supplemental residual antimicrobial products in place of broad-spectrum or hospital hard surface disinfectant data. 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.
    2. Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email [email protected] with your CDX tracking number (CDX_XXXX_XXXXXXX).

1 Liquid chemical disinfectants and devices used to disinfect health care facilities and non-critical medical devices may require separate FDA review. Other products (e.g., liquid chemical disinfectants and devices used against microorganisms in or on humans or other animals, liquid chemical sterilants for use on critical or semi-critical medical devices) may be subject to FDA’s exclusive jurisdiction and are outside the scope of this guidance.

2 This non-residual disinfectant testing should be conducted in accordance with the OCSPP 810.2200 Product Performance Test Guideline for each organism (vegetative bacterium and virus) for which residual claims are being requested. Per the 810.2200 Test Guideline, testing to support a base disinfectant (non-residual) claim should utilize the AOAC Use Dilution Method, Germicidal Spray Test, or Germicidal Spray Test modified for towelettes as appropriate. Testing should be conducted against the base bacteria Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa). Testing to support a virucidal (non-residual) claim should utilize ASTM E1053. The performance standards for each organism and product type are specified in the test guideline. Data to support both residual and non-residual disinfectant claims can be submitted and reviewed concurrently. The agency expects that products with residual disinfectant claims will also have non-residual disinfectant claims (i.e., products will not have only residual claims). In addition, data for residual bactericidal disinfectant claims should be submitted prior to or concurrently with data for residual virucidal claims.

Pesticide Registration

Contact Us about Pesticide Registration
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on September 12, 2024