Notice2023-20929
Pesticides; Concept for a Framework To Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial or Antifungal Pesticides; Notice of Availability and Request for Comment
Primary source
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Published
September 26, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on the concept for developing a framework to improve assessments of potential risks to human and animal health where the use of certain pesticides could potentially result in antimicrobial resistance (AMR) that compromises the effectiveness of medically important antibacterial and antifungal drugs. EPA is also seeking feedback on research gaps and other information to help inform the risk assessment and mitigation processes. The concept document was developed in collaboration with the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and offices within the White House Executive Office of the President. A pesticide must be registered with the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) before it can be legally sold or distributed in the United States. During the registration process, EPA considers whether the pesticide will cause unreasonable adverse effects on people or the environment. Because resistance is considered an adverse effect under FIFRA, the U.S. government is working to develop a structured and coordinated approach to assess and manage these risks. EPA is seeking public comment on a concept document for a proposed framework and on potential solutions, research, or mitigation approaches to reduce the spread of AMR. The agencies will consider feedback in developing a proposed framework that will also be shared for public review and comment.
Full Text
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<title>Federal Register, Volume 88 Issue 185 (Tuesday, September 26, 2023)</title>
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[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 65998-65999]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20929]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0445; FRL-11370-01-OCSPP]
Pesticides; Concept for a Framework To Assess the Risk to the
Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial
or Antifungal Pesticides; Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on the concept for
developing a framework to improve assessments of potential risks to
human and animal health where the use of certain pesticides could
potentially result in antimicrobial resistance (AMR) that compromises
the effectiveness of medically important antibacterial and antifungal
drugs. EPA is also seeking feedback on research gaps and other
information to help inform the risk assessment and mitigation
processes. The concept document was developed in collaboration with the
U.S. Department of Health and Human Services (HHS), the U.S. Department
of Agriculture (USDA), and offices within the White House Executive
Office of the President. A pesticide must be registered with the EPA
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
before it can be legally sold or distributed in the United States.
During the registration process, EPA considers whether the pesticide
will cause unreasonable adverse effects on people or the environment.
Because resistance is considered an adverse effect under FIFRA, the
U.S. government is working to develop a structured and coordinated
approach to assess and manage these risks. EPA is seeking public
comment on a concept document for a proposed framework and on potential
solutions, research, or mitigation approaches to reduce the spread of
AMR. The agencies will consider feedback in developing a proposed
framework that will also be shared for public review and comment.
DATES: Submit your comments on or before November 13, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0445, 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 and 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: Susan Jennings, Immediate Office
(7501M), Office of Pesticide Programs, Environmental Protection Agency,
1201 Constitution Ave. NW, Washington, DC 20004; telephone number:
(706) 355-8574; email address: <a href="/cdn-cgi/l/email-protection#513b343f3f383f36227f222422303f113421307f363e27"><span class="__cf_email__" data-cfemail="046e616a6a6d6a63772a777177656a446174652a636b72">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What is the Agency's authority for taking this action?
This action is being taken under the authority of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et
seq.).
B. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on a document that describes the concept for developing a proposed
framework to improve assessments of potential risks to human and animal
health where the use of certain pesticides could potentially result in
antimicrobial resistance that compromises the effectiveness of
medically important antibacterial and antifungal drugs. EPA is also
seeking feedback on research gaps and other information to help inform
the risk assessment and mitigation processes. The concept document was
developed in collaboration with the U.S. Department of Health and Human
Services (HHS), the U.S. Department of Agriculture (USDA), and offices
within the White House Executive Office of the President. A pesticide
must be registered with the EPA under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) before it can be legally sold or
distributed in the United States. During the registration process, EPA
considers whether the pesticide will cause unreasonable adverse effects
on people or the environment. Because resistance is considered an
adverse effect under FIFRA, the U.S. government is working to develop a
structured and coordinated approach to assess and manage these risks.
EPA is seeking public comment on a concept document for a proposed
framework and on potential solutions, research, or mitigation
approaches to reduce the spread of AMR. The agencies will consider
feedback in developing a proposed framework that will also be shared
for public review and comment.
C. Why is the Agency taking this action?
In the United States, more than 2.8 million antimicrobial-resistant
infections occur each year, resulting in more than 35,000 annual
deaths. Some antibacterial and antifungal pesticides used in
agriculture as well as some pesticides used in other settings, belong
to the same class as or share mechanisms of action with medically
important antimicrobial drugs used in human and veterinary medicine.
Recent evidence indicates that the use of some antifungal pesticides
can select for resistant organisms that pose a potential risk to human
and animal health. As new pesticides and uses are proposed, the
potential exists for these pesticides to select for pathogenic bacteria
or fungi that are resistant to medically important antimicrobial drugs,
including both FDA-approved drugs and those still undergoing clinical
trials.
D. Does this action apply to me?
This action is directed to the public in general, although this
action may be of particular interest to those persons who may be
interested in assessments of potential risks to human and animal health
where the use of certain pesticides could potentially result in
[[Page 65999]]
antimicrobial resistance that compromises the effectiveness of
medically important antibacterial and antifungal drugs. Since other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be interested in this
action. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI information to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and 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 the commenting
tips and instructions at https://www.epa.gov/dockets/commenting-epa-
dockets.
II. Request for Comments
EPA is seeking comment on the document entitled ``Soliciting
Feedback from Stakeholders on the Structure of a Proposed Framework to
Assess the Risk to the Effectiveness of Human and Animal Drugs Posed by
Certain Antibacterial or Antifungal Pesticides'' (also referred to as
the concept document), a copy of which is available in the docket. EPA
is also requesting public comments on potential solutions, research, or
mitigation approaches to reduce the spread of AMR, and is specifically
seeking public comment on the following questions for the proposed
framework:
<bullet> Is the concept for the proposed framework (see Figure 1 in
the concept document) appropriately defined and clear to stakeholders?
<bullet> Are there specific types of pesticides that should be
evaluated under the framework, either by class or function?
<bullet> What factors that should be considered in determining if a
proposed pesticide use constitutes a potential risk to human or animal
health due to AMR?
<bullet> How to determine which human and animal antimicrobial
drugs should be considered `medically important' and how should this
term be defined?
<bullet> What mitigation strategies are currently available to
address the risk of AMR developing because of pesticide use?
Comment is also requested on the list of research gaps that could
help inform risk assessment and mitigation addressed in this framework,
including agricultural methods or other processes that could minimize
the potential for these pesticides to select for resistant organisms
and strategies to prevent infection or colonization related to pathogen
exposure, including:
<bullet> How do organisms that might have developed resistance by
exposure to these pesticides come into contact with and cause illness
in humans or animals (e.g., through direct contact, inhalation,
ingestion, healthcare-associated transmission), and which human or
animal populations are most affected (e.g., agricultural workers,
persons handling compost, persons with immunocompromising conditions,
persons living near treated fields, animals for food production,
companion animals)?
<bullet> What are effective strategies to reduce the potential for
these pesticides to select for antimicrobial-resistant bacteria and
fungi? For example, which agricultural practices are effective in
reducing the potential for these pesticides to select for AMR,
including strategies to reduce the need for pesticide use and practices
that reduce the likelihood that pesticide use will result in resistance
emergence (e.g., crop rotations, specific pesticide formulations)?
<bullet> By which mechanisms do human or animal pathogenic bacteria
and fungi spread through populations after becoming resistant through
selection by these pesticides?
<bullet> What are the best approaches to determine the potential
for pesticides to select for antimicrobial-resistant pathogens, and do
chemical criteria exist that could help determine whether pesticides
are more or less likely to pose health risks to humans or animals?
Authority: 7 U.S.C. 136 et seq.
Dated: September 21, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-20929 Filed 9-25-23; 8:45 am]
BILLING CODE 6560-50-P
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