Draft Guidance for the Evaluation of Products for Claims Against Viruses; Notice of Availability and Request for Comments, 45417-45418 [2023-15077]

Download as PDF Federal Register / Vol. 88, No. 135 / Monday, July 17, 2023 / Notices facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. ddrumheller on DSK120RN23PROD with NOTICES1 III. Additional Information About Commenting on the Proposed Consent Decree Submit your comments, identified by Docket ID No. EPA–HQ–OGC–2023– 0349, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA’s docket at https:// www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https:// www.epa.gov/dockets/commenting-epadockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only. If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA’s electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. VerDate Sep<11>2014 17:10 Jul 14, 2023 Jkt 259001 Use of the https:// www.regulations.gov website to submit comments to EPA electronically is EPA’s preferred method for receiving comments. The electronic public docket system is an ‘‘anonymous access’’ system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ‘‘late.’’ EPA is not required to consider these late comments. Gautam Srinivasan, Associate General Counsel. [FR Doc. 2023–15083 Filed 7–14–23; 8:45 am] BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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. SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 45417 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: samalot.luisa@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: 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. E:\FR\FM\17JYN1.SGM 17JYN1 45418 Federal Register / Vol. 88, No. 135 / Monday, July 17, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 nonfood 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-pesticidesand-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 nonhealthcare 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. VerDate Sep<11>2014 17:10 Jul 14, 2023 Jkt 259001 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 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OGC–2019–0478; FRL–11160–01– OGC] Proposed Stipulated Partial Settlement Agreement, Endangered Species Act Claims Environmental Protection Agency (EPA). ACTION: Notice of proposed stipulated settlement agreement; request for public comment. AGENCY: In accordance with the Environmental Protection Agency (EPA) Administrator’s March 18, 2022 Memorandum, Consent Decrees and Settlement Agreements to Resolve Environmental Claims Against the Agency, notice is hereby given of a proposed stipulated settlement agreement in the United States District Court for the Northern District of California in the case of Center for Biological Diversity, et. al., v. United States Environmental Protection Agency, et al., No. 3:11–cv–0293 (N.D. Cal.). Plaintiffs alleged that EPA failed to comply with certain duties under the Endangered Species Act (ESA). Defendant-Intervenors join this proposed stipulated settlement agreement. SUMMARY: Written comments on the proposed stipulated settlement agreement must be received by August 16, 2023. ADDRESSES: Submit your comments, identified by Docket ID number EPA– DATES: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 HQ–OGC–2019–0478 online at https:// www.regulations.gov (EPA’s preferred method). Follow the online instructions for submitting comments. Instructions: All submissions received must include the Docket ID number for this action. Comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For detailed instructions on sending comments, see the ‘‘Additional Information about Commenting on the Proposed Stipulation and Stipulated Dismissal’’ heading under the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Michele Knorr, Pesticides and Toxic Substances Law Office, Office of General Counsel, U.S. Environmental Protection Agency; telephone: (202) 564–5631; email address: knorr.michele@epa.gov. SUPPLEMENTARY INFORMATION: I. Obtaining a Copy of the Proposed Stipulated Settlement Agreement The official public docket for this action (identified by EPA–HQ–OGC– 2019–0478) contains a copy of the proposed stipulated settlement agreement. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OEI Docket is (202) 566–1752. The electronic version of the public docket for this action contains a copy of the proposed stipulated settlement agreement and is available through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select ‘‘search.’’ II. Additional Information About the Proposed Stipulated Settlement Agreement On January 20, 2011, Plaintiffs (nongovernmental environmental organizations) filed a complaint in the United States District Court in the Northern District of California asserting E:\FR\FM\17JYN1.SGM 17JYN1

Agencies

[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
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