Notice2023-15077
Draft Guidance for the Evaluation of Products for Claims Against Viruses; Notice of Availability and Request for Comments
Primary source
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Published
July 17, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting comment on draft guidance to expand the availability of virucidal claims for antimicrobial pesticides and provide framework for registrants who seek to make such claims. This draft guidance reiterates recommended test methods and guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfections claims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 This draft guidance specifically covers the addition of a virucidal claims to a product that has met the criteria for a bactericidal disinfectant and/or sanitizer.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.
Full Text
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<title>Federal Register, Volume 88 Issue 135 (Monday, July 17, 2023)</title>
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[Federal Register Volume 88, Number 135 (Monday, July 17, 2023)]
[Notices]
[Pages 45417-45418]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15077]
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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Draft Guidance for the Evaluation of Products for Claims Against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.
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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availability of and soliciting comment on draft guidance to expand the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This draft guidance reiterates recommended test methods and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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#2e5d4f434f42415a00425b475d4f6e4b5e4f00494158"><span class="__cf_email__" data-cfemail="fc8f9d919d909388d29089958f9dbc998c9dd29b938a">[email protected]</span></a>.
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
<a href="http://regulations.gov">regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>. 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 <a href="https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances">https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances</a>.
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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