[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82237-82238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23471]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0288; FRL-11108-02-OCSPP]


Pesticides; Interim Guidance for the Evaluation of Products for 
Claims Against Viruses; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) 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. 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 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.

DATES: This interim guidance is effective October 10, 2024.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0288, is available online at 
https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in-person, 
is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tahirah Morris, Antimicrobial Division 
(7510M), Office of Pesticide Programs, Office of Chemical Safety and 
Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0798; email address: <a href="/cdn-cgi/l/email-protection#75181a07071c065b01141d1c07141d351005145b121a03"><span class="__cf_email__" data-cfemail="0c61637e7e657f22786d64657e6d644c697c6d226b637a">[email protected]</span></a>.

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

[[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.

    Dated: October 4, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-23471 Filed 10-9-24; 8:45 am]
BILLING CODE 6560-50-P


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