On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of draft guidance for the evaluation of products for claims against viruses. This new guidance provides the framework for registrants who seek to make virucidal claims for antimicrobial products.

This draft guidance reiterates recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for hard surface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. The draft guidance only covers the addition of virucidal claims to a product that has met the criteria for a bactericidal disinfectant and/or sanitizer.

The draft guidance does not cover adding virucidal claims to sterilant products.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.

EPA states that the draft guidance is not binding on EPA or any outside parties, and EPA may depart from said guidance where circumstances warrant and without prior notice. Registrants and applicants may propose and submit alternative practices (e.g., modifications to the recommended test methodology) to EPA for assessment.

Comments are due to EPA on or before September 15, 2023.

Product Eligibility and Test Criteria

EPA’s draft guidance proposes no change to the test methods or performance standards recommended for a product to meet any of the antimicrobial pesticide product definitions or to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 The expansion of the availability of virucidal claims under this draft guidance will facilitate the addition of virus claims to products bearing only sanitizer claims. Products should meet the test guidance requirements as described in OCSPP 810.2300 before a virucidal claim is added. EPA states that since there will be no changes to the test methods or performance standards recommended for virus claims, there is no concern about a reduced level of efficacy against viruses.

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, waiting rooms). 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 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 per batch should be tested, and for surrogates, two surfaces 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 below table).

*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.

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 to products that are ONLY sanitizers for a time-limited period of a maximum of seven 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 seven-year period.

A year prior to expiration of the time-limited registration, EPA will analyze the products registered under this guidance. Comments provided by industry and registrants, as well as product users, would be considered to determine if a revision to the guidance is necessary or if the guidance can be reissued without a time limitation. Prior to the end of the seven-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.

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 seven-year time-limited registration timeframe is to allow registrants to 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.

EPA states that should the guidance be terminated after seven years, the registrant(s) will engage with EPA on an appropriate pathway for sanitizer-only products with virucidal claims. Under the time-limited registration, the registrant(s) should contact EPA no later than one year prior to the expiration of the time-limited registration and inform EPA of any changes or comments regarding this guidance, as well as changes to the product(s) virucidal claims, as necessary.

If the registrant(s) wish to remove the virucidal claims from their sanitizer product(s), the registrant(s) should provide EPA with its (their) proposed path forward and timeframe that will be associated with the removal of these time-limited claims.

Label Guidance

EPA states the following draft guidance regarding labels:

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

1. 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.”

• Claim language such as the following may be added to the label to emphasize where the product is intended to be u[s]ed:

1. “May be used in residential facilities, schools, office premises, and non-healthcare settings” may be added to the label to emphasize where the product is intended to be used.

2. “Can be used in households, commercial, and institutional settings, such as (but not limited to): homes, professional offices, schools, cafeterias (both in healthcare or non-healthcare settings), garages, gyms, playground and play areas, and others.”

• 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. 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. “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. 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.

2. “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 draft guidance is “intended to allow registrants to provide consumers with additional products that are effective against viruses including SARS-CoV-2.” This draft guidance is important for sanitizer registrants seeking to add virucidal claims, although EPA has provided several caveats to this process that may be equally important. This guidance, for example, does not apply to registrants of sterilant products that may be interested in adding virucidal claims. In addition, any approved registration or amendment adding viral claims to a sanitizer product will be limited to a maximum seven-year period. Prior to the seven-year expiration, EPA will evaluate the products against its guidance to determine if the guidance can be re-issued without a time limitation or if the guidance will be terminated after the seven years. If the guidance is terminated, then the registrant will need to engage with EPA on an appropriate pathway for its sanitizer-only products with virucidal claims.

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