On October 10, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of interim guidance to expand the availability of virucidal claims for antimicrobial pesticides. This new guidance provides the framework for registrants who seek to make virucidal claims for antimicrobial products that meet the criteria for a bacterial disinfectant and/or sanitizer (e.g., household antimicrobial wipes and sprays) consistent with current test guidelines.

EPA states that it intends to grant the addition of virucidal claims associated with sanitizer claims for a time-limited period of a maximum of ten years. Prior to the ten-year expiration, EPA will assess implementation, review the record and may terminate the interim policy, make suggestions for changes to the policy, as necessary, or decide to make the policy permanent.

This interim guidance reiterates recommended test methods and regulatory guidance discussed in the draft guidance released by EPA on July 17, 2023, for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims consistent with EPA’s Product Performance Test Guidelines; OCSPP 810.2200: Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing guideline and provides recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for food/non-food contact sanitizer claims consistent with EPA’s Product Performance Test Guidelines; OCSPP 810.2300: Sanitizers for Use on Hard Surfaces — Efficacy Data Recommendations test guideline. EPA states that the methods and performance standards applicable to this expanded availability of virucidal claims are the same test methods and performance standards that are currently used to support existing virucidal claims; thus, there are no expectations of a reduction of product performance against viruses.

EPA states that additional anticipated benefits include the availability of more products with reduced contact times (i.e., time the surface must remain wet) and/or more products on EPA’s Design for the Environment (DfE) list that are also effective against viruses.

The interim guidance does not cover adding virucidal claims to sterilant products. In addition, this guidance is not intended to cover residual (long-lasting) sanitizer claims. If residual claims are to be added to the product label, visit https://www.epa.gov/pesticide-registration/guidance-products-adding-residual-efficacy-claims.

Product Eligibility and Test Criteria

EPA’s interim guidance proposes no change to the test methods or performance standards recommended for a product to meet any of the antimicrobial pesticide product definitions or to fall under the categories of claims on such products. The expansion of the availability of virucidal claims under this interim guidance will facilitate the addition of virus claims to products bearing only food or non-food sanitizer claims. Products should meet the test guidance requirements as described in OCSPP 810.2300 before a virucidal claim is added.

Products that meet the basic criteria to allow for sanitizer claims, as outlined in the current OCSPP 810.2300 test guideline, and have data to support the addition of virucidal label claims, may be used in non-healthcare use sites in residential, commercial, and institutional settings (e.g., cafeterias specifically on hard, non-porous surfaces). Furthermore, addition of a virucidal claim to a product bearing only sanitizer claims does not imply that the product can be used in healthcare settings, due to the higher level of efficacy against bacteria that is expected in hospital patient care areas.

To add a virucidal claim to either a disinfectant or a sanitizer, utilize OCSPP 810.2200, Section G, “Virucidal Claims” to develop virucidal data.

• As specified in OCSPP 810.2200, two batches (lots) of product at the Lower Certified Limit (LCL) should be tested for the hardest to kill virus strain on the product label. For all additional viruses, two batches of product at the nominal concentration should be tested. Testing can be conducted on virus surrogates and non-surrogates, as specified in the 810.2200 guidance. For non-surrogate viruses, one surface carrier per batch should be tested, and for surrogates, two surface carriers per batch.
   
  • Surrogates are alternative microbes or strains of microbes used to represent a pathogenic public health organism, typically used due to biosafety concerns, ease of culturing, and/or availability.
  • The maximum contact time to achieve the performance standard for viruses should be consistent with the maximum contact time for the bactericidal claim (provided in the table below).

*AOAC = AOAC International (formerly Association of Official Analytical Chemists)/ASTM = ASTM International (formerly American Society for Testing and Materials)

Regulatory Submission Process and Implementation

Applicants seeking product registration(s) or registration amendment(s) under this new policy should follow the regulatory and submission process for registration for antimicrobial products. Applicants seeking product registrations, submitting no new data, should follow the process for the non-coded Pesticide Registration Improvement Act (PRIA) fast-track amendments. When submitting a new product registration and/or a label amendment, provide an accompanying cover letter, including the intent to submit under this time limited guidance, along with the product-specific Terms of Registration

EPA states that the expansion of the availability of virucidal claims represents a significant policy shift. As such, EPA intends to grant the addition of virucidal claims associated with sanitizer claims for a time-limited period of a maximum of ten years, starting from the date the guidance is finalized for use. Registrants interested in registering sanitizer products with virucidal claims or adding virucidal claims to previously registered sanitizer products should do so within the ten-year period. The time-limited period will expire on October 10, 2034.

Public comments provided through www.regulations.gov under docket ID: EPA-HQ-OPP-2023-0288 on or before October 10, 2032, will be considered to determine if a revision to the guidance is necessary or if the guidance can be re-issued without a time limitation. Prior to the end of the ten-year period, EPA will review the record and may make suggestions for changes to the policy, as necessary, or decide to make the policy permanent. The time-limited registration applies to all products seeking to obtain such registration and it is not an individualized time period. For example, if a registrant were to submit an application to add a new virucidal claim to a sanitizer-only product on September 1, 2029, that product claim would be valid until October 10, 2034.

Products registered under this time-limited registration will receive a registration with terms and conditions. These time-limited registrations will be tracked internally to capture all products under this registration and provide a way for communication with the registrants, as necessary. EPA states that the purpose of the ten-year time-limited registration timeframe is to allow registrants to come forth and use the guidance for registration and for EPA to evaluate the benefits, concerns, and related experience to inform a decision on the permanence of this interim guidance.

Label Guidance

EPA states the following interim guidance language regarding labels intended to provide general examples of potential label language pertaining to new virucidal claims on products that have only sanitizer claims:

• Define Use Directions appropriately and separate according to the relevant test microbes, efficacy claims, and contact times to avoid end user confusion.

   

  1. i. It is recommended to organize claims using headings and sub-headings to better organize the label claims.

      

• For products that only have sanitizer claims seeking a virucidal claim, this language should be present on the label to indicate the product should not be used in patient care areas of healthcare settings, for example — “Not for use in patient care areas of hospital/healthcare facilities.”

   

  1. i. Patient care areas include all areas of a hospital or healthcare setting where direct patient care is delivered and where patient diagnostic or treatment procedures are performed (i.e., operating rooms, nursing homes, dialysis centers, birthing rooms, cancer treatment facilities, emergency rooms, waiting rooms).

      

  2. ii. Examples of non-patient care areas include, hospital cafeterias, staff break rooms, receptionist desks, billing and coding spaces.

      

  3. iii. To emphasize proper use of the products, claim language such as, “Not for use as a disinfectant” may be added to the label to help differentiate product performance for the end user.

      

• The following claim language may be added to the label to emphasize where the product is intended to be used:

   

  1. i. “May be used in residential facilities, schools, office premises, and non-healthcare settings”

      

  2. ii. “Can be used in households, commercial, and institutional settings, such as: homes, professional offices, schools, cafeterias (both in healthcare or non-healthcare settings), garages, gyms, playground and play areas.”

      

• Claim language for Virucide use directions should follow a header such as, “USE DIRECTIONS for VIRUCIDES ONLY.”

   

• For products with only sanitizer claims that are seeking a virucidal claim (not a disinfection claim), language such as: “Kills bacteria AND viruses*,” Sanitizer, Virucide*/Virucidal*, “For residential, commercial and/or industrial use,” are acceptable.

   

  1. i. Note: Claims including a reference to viruses (such as those denoted with the asterisk in the example above) should be qualified on label with a list of specific viruses tested for efficacy and submitted to the Agency for review.

      

• The following are examples of claims that would generally not be acceptable on the label of a product containing sanitizer only claims seeking addition of virucidal claims:

   

  1. i. “Kills germs” — as this term is too broad and should be used only on products with efficacy data against viruses, bacteria and fungi. See the following for additional information: https://www.epa.gov/pesticide-labels/use-term-germs-antimicrobial-labels.

      

  2. ii. Unqualified virus claims — all claims regarding killing viruses should be qualified (e.g., marked with an asterisk that links to the list of viruses) with specific viruses tested for efficacy and submitted to the Agency for review.

      

  3. iii. “For use in hospital or healthcare settings” — Use sites for sanitizers should be limited to non-patient care associated settings, even if virus claims are present.

Commentary

EPA states that the interim guidance is “intended to allow registrants to provide consumers with additional products that are effective against viruses including SARS-CoV-2.” This interim guidance is important for sanitizer registrants seeking to add virucidal claims, although EPA has provided the caveat that this interim guidance has a time-limited period of a maximum of ten years, starting from the date the guidance is finalized for use. The time-limited period will expire on October 10, 2034; thus, the specific claims would be valid until this date.

Affected registrants or potential registrants should review the interim guidance carefully.