[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]



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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

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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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