Document ID: EPA-HQ-OPP-2023-0288-0001
Agency: epa
Document Type: Notice
Title: Guidance: Evaluation of Products for Claims against Viruses
Posted Date: 2023-07-17T04:00Z

[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45417-45418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15077]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0288; FRL-11108-01-OCSPP]

Draft Guidance for the Evaluation of Products for Claims Against 
Viruses; Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting comment on draft guidance to expand the 
availability of virucidal claims for antimicrobial pesticides and 
provide framework for registrants who seek to make such claims.
    This draft guidance reiterates recommended test methods and 
guidance for the addition of virucidal claims to products that meet the 
criteria for hard surface disinfections 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 
draft guidance specifically covers the addition of a virucidal claims 
to a product that has met the criteria for a bactericidal disinfectant 
and/or sanitizer. 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 on 
reduction of product performance against viruses.

DATES: Submit your comments on or before September 15, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2023-0288, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Luisa Samalot, Office of Chemical 
Safety and Pollution Prevention, Antimicrobial Division (7510M), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 566-0609; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This notice is directed to the general public and may be of 
specific interest to persons or entities that register antimicrobial 
pesticides. Because other entities may also be interested in this 
notice, the agency has not attempted to describe all the specific 
entities that may be interested in this subject. If you have any 
questions regarding the applicability of this action to a particular 
entity, contact the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see Tips for Effective Comments at https://www.epa.gov/dockets. Please note that once submitted, comments cannot be edited or 
removed from the docket. The EPA may publish any comment received to 
its public docket.

[[Page 45418]]

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.
    EPA received requests for guidance to add virucidal claims to 
products with sanitizing claims on hard surfaces. There is a 
significant interest from stakeholders and the public to add these 
virucidal claims to products with sanitizer label claims.
    This 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 reiterates recommended test 
methods and guidance for the addition of virucidal claims to products 
that meet the criteria for hard surface disinfections claims in OCSPP 
810.2200, Disinfectants for Use on Environmental Surfaces, Guidance for 
Efficacy Testing (EPA publication No. 712-C-17-004 (2018)).
    Products should meet the test guidance requirements as described in 
OCSPP 810.2300 Sanitizers for Use on Hard Surfaces--Efficacy Data 
Recommendations (EPA publication No. 712-C-07-091 (2012)), (food or 
non-food contact sanitization) to treat hard, non-porous surfaces 
before a virucidal claim is added.
    OCSPP test guidelines can be accessed online through https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.
    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, may be used only in non-healthcare 
use-sites in residential, commercial and institutional settings (e.g., 
cafeterias, waiting rooms) 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 draft 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.

Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-15077 Filed 7-14-23; 8:45 am]
BILLING CODE 6560-50-P