[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
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