SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This action is directed to the general public and may be of specific interest to persons or entities that register antimicrobial pesticides. Since a potentially broad range of entities may be interested in this action, the Agency has not attempted to describe all the specific entities that may be interested. If you have any questions regarding the applicability of this interim guidance to a particular entity or registration action, contact the person listed under FOR FURTHER INFORMATION CONTACT .

B. What is the Agency's authority for taking this action?

EPA is issuing this guidance pursuant to its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.

C. What action is the Agency taking?

EPA is announcing the availability of interim guidance to expand the availability of virucidal claims for antimicrobial pesticides and provide a framework for registrants who seek to make such claims. The guidance document was revised based on the public comments received in 2023 (88 FR 45418, July 17, 2023 (FRL-11108-01-OCSPP). EPA received 5 comments, which are summarized and responded to in a response to comment document that is available in the docket.

This interim guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims and ( printed page 82238) the addition of virucidal claims to products that meet the criteria for food/non-food contact sanitizer claims consistent with current test guidelines. This guidance specifically covers the addition of a virucidal claim to a product that has met the criteria for a bactericidal disinfectant and/or sanitizer.

Pursuant to this guidance, the Agency 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 end of the ten-year period, the Agency will review the record and may terminate the policy, make suggestions for changes to the policy, as necessary, or decide to make the policy permanent. 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 and thus there are no expectations of a reduction of product performance against viruses.

II. Background

Historically, EPA has approved claims for efficacy against viruses only as additional claims on certain antimicrobial products, such as those with sterilant and disinfectant claims, but not those that bear only sanitizer claims.

This guidance is intended to allow registrants to provide consumers with additional products that are effective against viruses including SARS-CoV-2. This guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims in OCSPP 810.2200, Disinfectants for Use on Environmental Surfaces, Guidance for Efficacy Testing.

Products with only sanitizer claims should meet the test guidance requirements as described in OCSPP 810.2300 Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations (food or non-food contact sanitization) to treat hard, non-porous surfaces before a virucidal claim is added pursuant to this guidance.

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 and have data to support the addition of virucidal label claims pursuant to this guidance, may be used in non-healthcare use-sites in residential, commercial, and institutional settings ( e.g., cafeterias specifically on hard, non-porous surfaces).

Additional anticipated benefits include the availability of more products with reduced contact times (time the surface must remain wet) and/or more products on EPA's Design for the Environment list that are also effective against viruses. The expansion of the availability of virucidal claims under this guidance will facilitate the addition of virus claims to products bearing only sanitizer claims.

III. Do guidance documents contain binding requirements?

As guidance, these documents are not binding on the Agency or any outside parties, and the Agency may depart from it where circumstances warrant and without prior notice. While EPA has made every effort to ensure the accuracy of the discussion in the guidance, the obligations of EPA and the regulated community are determined by statutes, regulations, or other legally binding documents. In the event of a conflict between the discussion in the guidance documents and any statute, regulation, or other legally binding document, the guidance documents will not be controlling.

Authority:7 U.S.C. 136 et seq.