[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]]
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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.
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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]
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