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, 65998-65999 [2023-20929]
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Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices
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Dated: September 20, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023–20887 Filed 9–25–23; 8:45 am]
BILLING CODE 6717–01–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:18 Sep 25, 2023
Jkt 259001
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 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 and visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
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: jennings.susan@
epa.gov.
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices
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 https://www.regulations.gov or
email. If you wish to include CBI in
your comment, please follow the
applicable instructions at https://
www.epa.gov/dockets/commenting-epadockets#rules 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.
lotter on DSK11XQN23PROD with NOTICES1
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:
• Is the concept for the proposed
framework (see Figure 1 in the concept
document) appropriately defined and
clear to stakeholders?
• Are there specific types of
pesticides that should be evaluated
under the framework, either by class or
function?
• 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?
VerDate Sep<11>2014
18:18 Sep 25, 2023
Jkt 259001
• How to determine which human
and animal antimicrobial drugs should
be considered ‘medically important’ and
how should this term be defined?
• 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:
• 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)?
• 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)?
• By which mechanisms do human or
animal pathogenic bacteria and fungi
spread through populations after
becoming resistant through selection by
these pesticides?
• 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]
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–11421–01–OA]
Establishment of Historically Black
Colleges and Universities (HBCUs) and
Minority Serving Institutions (MSIs)
Advisory Council
Environmental Protection
Agency (EPA).
AGENCY:
Notice; establishment of the
Historically Black Colleges and
Universities and Minority Serving
Institutions Advisory Council.
ACTION:
As required by the Federal
Advisory Committee Act (FACA), the
United States Environmental Protection
Agency (EPA) is giving notice that it is
establishing the Historically Black
Colleges and Universities and Minority
Serving Institutions Advisory Council.
The purpose of this committee is to
provide advice and recommendations to
the EPA Administrator on critical policy
and technical issues to advance equity
in economic and social opportunities for
all Americans and strengthen the
capacity of HBCUs and MSIs to provide
the highest-quality education,
participate in and benefit from federal
programs, and support key
Administration policies. The EPA has
determined that this federal advisory
committee is necessary and in the
public interest to provide critical advice
and recommendations to assist the EPA
in increasing outreach to
underrepresented and underserved
communities by developing a stronger
partnership with HBCUs and MSIs.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Pradnya Bhandari, Designated Federal
Officer, U.S. EPA, 1200 Pennsylvania
Avenue NW (Mail code 1448K),
Washington, DC 20460, at 202–564–
0381 or by email to bhandari.pradnya@
epa.gov.
The
Historically Black Colleges and
Universities and Minority Serving
Institutions Advisory Council will be
established for a two-year period.
Copies of the committee charter will be
filed with the appropriate congressional
committees and the Library of Congress.
SUPPLEMENTARY INFORMATION:
Kathryn Jakob,
Director, Office of Public Engagement.
[FR Doc. 2023–20878 Filed 9–25–23; 8:45 am]
BILLING CODE 6560–50–P
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 65998-65999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20929]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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 and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
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: [email protected].
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 https://www.regulations.gov or email. If you wish to include CBI in your
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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:
Is the concept for the proposed framework (see Figure 1 in
the concept document) appropriately defined and clear to stakeholders?
Are there specific types of pesticides that should be
evaluated under the framework, either by class or function?
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?
How to determine which human and animal antimicrobial
drugs should be considered `medically important' and how should this
term be defined?
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:
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)?
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)?
By which mechanisms do human or animal pathogenic bacteria
and fungi spread through populations after becoming resistant through
selection by these pesticides?
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
