Notice2024-23471
Pesticides; Interim Guidance for the Evaluation of Products for Claims Against Viruses; Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 10, 2024
Effective
October 10, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 197 (Thursday, October 10, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82237-82238]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-23471]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 10, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.