Pesticides; White Paper: Framework for Interagency Collaboration To Review Potential Antibacterial and Antifungal Resistance Risks Associated With Pesticide Use; Notice of Availability and Request for Comment, 54819-54820 [2024-14493]
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Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices
B. What action is the Agency taking?
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2023–0445; FRL–11370–03–
OCSPP]
Pesticides; White Paper: Framework
for Interagency Collaboration To
Review Potential Antibacterial and
Antifungal Resistance Risks
Associated With Pesticide Use; Notice
of Availability and Request for
Comment
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA or Agency) is announcing
the availability of and soliciting public
comment on a framework for expanding
interagency collaboration to improve the
communication and knowledge base
within the federal family to fully
consider potential adverse impact of
pesticides on efficacy of human and
animal drugs. In particular, the use of
antifungal and antibacterial pesticides,
that can potentially lead to resistance in
human and animal pathogens and may
compromise the effectiveness of
medically important antibacterial and
antifungal drugs.
DATES: Submit your comments on or
before August 1, 2024.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2023–0445,
through 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
lotter on DSK11XQN23PROD with NOTICES1
Susan Jennings, Immediate Office
(7501M), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; 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.).
VerDate Sep<11>2014
17:34 Jul 01, 2024
Jkt 262001
EPA is announcing the availability of
and requesting comment on a
framework that outlines a process for
EPA’s collaboration with other federal
agencies that recognizes the benefits of
these pesticides to agriculture while
minimizing their impact on public
health and considers the goals of the
One Health approach. While developing
this framework, EPA has coordinated
with HHS and USDA, under the
oversight of the White House Executive
Office of the President. Each of these
agencies is charged with protecting
health in areas that are directly
impacted by resistance resulting from
pesticides or drug products used to
protect humans, animals, or plants. This
framework clarifies that EPA intends to
establish a process with those other
federal agencies to consider their input
when EPA evaluates antibacterial and
antifungal pesticide products that may
adversely impact the efficacy of human
or animal drugs.
EPA is issuing this white paper to
provide information and clarification to
pesticide applicants, growers, the public
health community, and the public about
EPA’s process for considering resistance
issues related to regulatory decisions on
antibacterial and antifungal pesticides
with other federal agencies. While the
requirements in FIFRA and the EPA
regulations are binding on EPA and
applicants, this white paper is not
binding on EPA personnel, pesticide
registrants and applicants, or the public.
EPA may depart from the framework
where circumstances warrant and
without prior notice. Likewise, pesticide
applicants may assert that the
framework is not applicable to a specific
pesticide or decision. Registrants and
applicants may also propose alternative
processes to the final framework in any
application to EPA.
This framework is being published
with a 30-day public comment period.
EPA will consider any feedback
received in producing the final
framework, which EPA intends to issue
by the end of 2024.
C. Why is the Agency taking this action?
Antimicrobial resistance in bacteria
and fungi is a top threat to the public’s
health and a priority across the globe.
The Centers for Disease Control and
Prevention report that there are nearly 3
million antimicrobial-resistant
infections and more than 35,000
associated deaths in the U.S. each year.
According to USDA, plant diseases are
also persistent threats to agricultural
crops and global food security, having a
significant impact on yields and quality.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
54819
These diseases result in billions of
dollars in economic losses and
management inputs each year to crops,
landscapes, and forests in the U.S. Plant
diseases reduce yields, lower product
quality or shelf-life, decrease aesthetic
or nutritional value, and may
contaminate food and feed with toxic
compounds.
Some antibacterial and antifungal
pesticides used in agriculture and in
other settings belong to the same class
as or share mechanisms of action with
important antimicrobial drugs used in
human and veterinary medicine.
On September 26, 2023, EPA and the
other federal agencies issued a
document entitled ‘‘Concept Note:
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’’ (88 FR 65998)
(FRL–11370–01–OCSPP). The concept
note was intended to be the first step in
creating a process 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. The concept note
solicited stakeholder input on the
proposed structure for the process and
potential solutions, research, and
mitigation approaches to reduce the
spread of resistance. The concept note
posed several questions about how
resistance occurs and is spread. The
Agency received many comments;
however, very few directly responded to
the specific charge questions asked by
the concept paper. The agencies did not
receive sufficient information to resolve
the many scientific questions about
assessing the potential risk of antifungal
or antibacterial pesticides to adversely
impact the efficacy of human or animal
drugs.
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
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
E:\FR\FM\02JYN1.SGM
02JYN1
54820
Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 / Notices
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 email or https://
www.regulations.gov. 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 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 ‘‘Pesticides: White
Paper: Framework for Interagency
Collaboration to Review Potential
Antibacterial and Antifungal Resistance
Risks Associated with Pesticide Use
Pesticides; Notice of Availability and
Request for Comment’’ (also referred to
as the framework document), a copy of
which is available in the docket.
Authority: 7 U.S.C. 136 et seq.
Dated: June 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2024–14493 Filed 7–1–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
lotter on DSK11XQN23PROD with NOTICES1
[CERCLA 01–2024–0015; EPA–R01–
SFUND–2024–0214; FRL–11942–01–R1]
Prospective Purchaser Proposed
Settlement Agreement and Covenant
Not To Sue Pursuant to the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980, as Amended; in Re: Olin
Chemical Superfund Site, Located in
Wilmington, Massachusetts
Environmental Protection
Agency (EPA).
AGENCY:
VerDate Sep<11>2014
17:34 Jul 01, 2024
Jkt 262001
Notice of proposed settlement
agreement; request for public comment.
ACTION:
The U.S. Environmental
Protection Agency (‘‘EPA’’) is hereby
providing notice of a proposed
prospective purchaser settlement
agreement between EPA and
prospective purchaser Wilmington
Woburn Industrial, LLC (‘‘Settling
Party’’), which has an agreement to
acquire the property located at 51 Eames
Street in Wilmington, Middlesex
County, Massachusetts, encompassing
approximately 50 acres (‘‘Property’’),
from Olin Corporation (‘‘Contract’’),
embodied in an Administrative
Agreement for Payment of Response
Costs by Prospective Purchaser
(‘‘Settlement Agreement’’). The
proposed Settlement Agreement, EPA
Region 1 CERCLA Docket No. 01–2024–
0015, pertains to the Olin Chemical
Superfund Site in Wilmington,
Massachusetts (‘‘Site’’) and the Property,
which is a portion of the Site. The
proposed Settlement Agreement is
entered into pursuant to the
Comprehensive Environmental
Response, Compensation, and Liability
Act, as amended (‘‘CERCLA,’’ also
known as the Superfund law), and the
authority of the Attorney General of the
United States to compromise and settle
claims of the United States.
On September 28, 2023, the U.S.
District Court for the District of
Massachusetts entered the Consent
Decree in United States of America and
Commonwealth of Massachusetts v.
American Biltrite Inc., et al. case (1:23–
cv–11044), in which American Biltrite
Inc., NOR–AM Agro LLC, Olin
Corporation, and Stepan Company
(‘‘Settling Defendants’’) agreed to
implement the remedy selected in the
Record of Decision issued by EPA for
the Site on March 30, 2021 (‘‘Record of
Decision’’). The proposed Settlement
Agreement requires the Settling Party to
provide full cooperation, assistance, and
access to persons authorized to conduct
response actions at the Property,
including Settling Defendants’
implementation, under EPA oversight,
of the remedy embodied in the Record
of Decision in accordance with the
Consent Decree. The proposed
Settlement Agreement also requires the
Settling Party to perform certain
remedial design and remedial action
activities pursuant to the Contract in
coordination with Settling Defendants
and in accordance with the terms of the
Consent Decree and associated
Statement of Work. Under the proposed
Settlement Agreement, the Settling
Party will make a payment to EPA of
$73,202.39 as well as pay EPA for future
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
costs in supporting, developing,
implementing, overseeing, or enforcing
the Agreement. The Settling Party
consents to and will not contest the
authority of the United States to enter
into this proposed Settlement
Agreement or to implement or enforce
its terms. The Settling Party recognizes
that this proposed Settlement
Agreement has been negotiated in good
faith and that this Agreement is entered
into without the admission or
adjudication of any issue of fact or law.
DATES: Comments must be submitted by
August 1, 2024.
ADDRESSES: The proposed Settlement
Agreement and related Site documents
are available at EPA’s website https://
www.epa.gov/superfund/olin or by
going to https://cumulis.epa.gov/
supercpad/SiteProfiles/index.
cfm?fuseaction=second.ars&id=0100438
&doc=Y&colid=67528®ion
=01&type=AR. The proposed Settlement
Agreement and related Site documents
are available for public inspection at the
U.S. EPA, Region 1, SEMS Records and
Information Center, 5 Post Office
Square, Suite 100, Boston, MA 02109 by
appointment only (by calling 617–918–
1440 or by emailing r1.records-sems@
epa.gov). The proposed Settlement
Agreement is also available for public
inspection at https://
www.regulations.gov by searching for
Docket ID No. EPA–R01–SFUND–2024–
0214. Submit your comments online via
https://www.regulations.gov (Docket ID
No. EPA–R01–SFUND–2024–0214).
Follow the online instructions for
submitting comments.
FOR FURTHER INFORMATION CONTACT:
Maximilian Boal, Senior Enforcement
Counsel, Office of Regional Counsel,
U.S. Environmental Protection Agency,
Region 1, 5 Post Office Square, Suite
100, Mail Code: 4–02, Boston, MA
02109, (617) 918–1750, email:
boal.maximilian@epa.gov.
SUPPLEMENTARY INFORMATION: Once
submitted, comments cannot be edited
or removed from Regulations.gov. Do
not submit electronically 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 the full
EPA public comment policy,
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54819-54820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14493]
[[Page 54819]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0445; FRL-11370-03-OCSPP]
Pesticides; White Paper: Framework for Interagency Collaboration
To Review Potential Antibacterial and Antifungal Resistance Risks
Associated With Pesticide Use; Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of and soliciting public comment on a
framework for expanding interagency collaboration to improve the
communication and knowledge base within the federal family to fully
consider potential adverse impact of pesticides on efficacy of human
and animal drugs. In particular, the use of antifungal and
antibacterial pesticides, that can potentially lead to resistance in
human and animal pathogens and may compromise the effectiveness of
medically important antibacterial and antifungal drugs.
DATES: Submit your comments on or before August 1, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0445, through 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,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; 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 requesting comment on a
framework that outlines a process for EPA's collaboration with other
federal agencies that recognizes the benefits of these pesticides to
agriculture while minimizing their impact on public health and
considers the goals of the One Health approach. While developing this
framework, EPA has coordinated with HHS and USDA, under the oversight
of the White House Executive Office of the President. Each of these
agencies is charged with protecting health in areas that are directly
impacted by resistance resulting from pesticides or drug products used
to protect humans, animals, or plants. This framework clarifies that
EPA intends to establish a process with those other federal agencies to
consider their input when EPA evaluates antibacterial and antifungal
pesticide products that may adversely impact the efficacy of human or
animal drugs.
EPA is issuing this white paper to provide information and
clarification to pesticide applicants, growers, the public health
community, and the public about EPA's process for considering
resistance issues related to regulatory decisions on antibacterial and
antifungal pesticides with other federal agencies. While the
requirements in FIFRA and the EPA regulations are binding on EPA and
applicants, this white paper is not binding on EPA personnel, pesticide
registrants and applicants, or the public. EPA may depart from the
framework where circumstances warrant and without prior notice.
Likewise, pesticide applicants may assert that the framework is not
applicable to a specific pesticide or decision. Registrants and
applicants may also propose alternative processes to the final
framework in any application to EPA.
This framework is being published with a 30-day public comment
period. EPA will consider any feedback received in producing the final
framework, which EPA intends to issue by the end of 2024.
C. Why is the Agency taking this action?
Antimicrobial resistance in bacteria and fungi is a top threat to
the public's health and a priority across the globe. The Centers for
Disease Control and Prevention report that there are nearly 3 million
antimicrobial-resistant infections and more than 35,000 associated
deaths in the U.S. each year. According to USDA, plant diseases are
also persistent threats to agricultural crops and global food security,
having a significant impact on yields and quality. These diseases
result in billions of dollars in economic losses and management inputs
each year to crops, landscapes, and forests in the U.S. Plant diseases
reduce yields, lower product quality or shelf-life, decrease aesthetic
or nutritional value, and may contaminate food and feed with toxic
compounds.
Some antibacterial and antifungal pesticides used in agriculture
and in other settings belong to the same class as or share mechanisms
of action with important antimicrobial drugs used in human and
veterinary medicine.
On September 26, 2023, EPA and the other federal agencies issued a
document entitled ``Concept Note: 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'' (88 FR 65998) (FRL-11370-01-OCSPP). The
concept note was intended to be the first step in creating a process 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. The concept note solicited
stakeholder input on the proposed structure for the process and
potential solutions, research, and mitigation approaches to reduce the
spread of resistance. The concept note posed several questions about
how resistance occurs and is spread. The Agency received many comments;
however, very few directly responded to the specific charge questions
asked by the concept paper. The agencies did not receive sufficient
information to resolve the many scientific questions about assessing
the potential risk of antifungal or antibacterial pesticides to
adversely impact the efficacy of human or animal drugs.
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
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
[[Page 54820]]
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 email or https://www.regulations.gov. 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 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 ``Pesticides: White
Paper: Framework for Interagency Collaboration to Review Potential
Antibacterial and Antifungal Resistance Risks Associated with Pesticide
Use Pesticides; Notice of Availability and Request for Comment'' (also
referred to as the framework document), a copy of which is available in
the docket.
Authority: 7 U.S.C. 136 et seq.
Dated: June 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-14493 Filed 7-1-24; 8:45 am]
BILLING CODE 6560-50-P
