[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82236-82237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22947]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0445; FRL-11370-05-OCSPP]


Pesticides; Framework for Interagency Collaboration To Review 
Potential Antibacterial and Antifungal Resistance Risks Associated With 
Pesticide Use; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of the final 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: The Framework is effective October 10, 2024.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0445, is available online at 
https://www.regulations.gov. Additional instructions for 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: <a href="/cdn-cgi/l/email-protection#deb4bbb0b0b7b0b9adf0adabadbfb09ebbaebff0b9b1a8"><span class="__cf_email__" data-cfemail="bdd7d8d3d3d4d3dace93cec8cedcd3fdd8cddc93dad2cb">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. 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 to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. 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.).

C. What action is the Agency taking?

    EPA is announcing the availability of a final 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 Framework 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 Framework 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.

D. 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.
    Determining a compound's potential to result in the development of 
antimicrobial resistance is complex. This Framework is intended to 
expand interagency collaboration to improve the

[[Page 82237]]

communication and knowledge base within the federal family to fully 
consider potential adverse impact of pesticides on efficacy of human 
and animal antibacterial and antifungal drugs.

II. Background

    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.
    On July 2, 2024, EPA announced the availability of and requested 
comment on the draft framework entitled ``Pesticides; Final White 
Paper: Framework for Interagency Collaboration to Review Potential 
Antibacterial and Antifungal Resistance Risks Associated with Pesticide 
Use'' (89 FR 54819) (FRL-11370-03-OCSPP). Fourteen comments were 
received. Commenters included grower groups (three), industry groups 
(four), consulting groups (one), public interest groups (one), human 
health groups (three), animal health group (one), and one private 
citizen.
    These groups raised a number of issues. The industry and grower 
groups stressed the benefits of pesticides, the need for a transparent 
process, concerns about the research uncertainties, and several 
advocated for EPA to wait to take action until the scientific issues 
are more resolved. The health groups were concerned about the 
implications of resistance to humans and animals who need effective 
drugs to combat disease.
    All public comments and EPA's responses to comments received, 
including those that do not raise significant issues or substantially 
change the proposed requirements, are included in Response to Comments 
document that is available in the docket for this action. After 
considering the public comments, EPA is issuing the Framework.
    Authority: 7 U.S.C. 136 et seq.

    Dated: September 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-22947 Filed 10-9-24; 8:45 am]
BILLING CODE 6560-50-P


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