[Federal Register Volume 88, Number 185 (Tuesday, September 26, 2023)]
[Notices]
[Pages 65998-65999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20929]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0445; FRL-11370-01-OCSPP]


Pesticides; Concept for a Framework To Assess the Risk to the 
Effectiveness of Human and Animal Drugs Posed by Certain Antibacterial 
or Antifungal Pesticides; Notice of Availability and Request for 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting public comment on the concept for 
developing a framework to improve assessments of potential risks to 
human and animal health where the use of certain pesticides could 
potentially result in antimicrobial resistance (AMR) that compromises 
the effectiveness of medically important antibacterial and antifungal 
drugs. EPA is also seeking feedback on research gaps and other 
information to help inform the risk assessment and mitigation 
processes. The concept document was developed in collaboration with the 
U.S. Department of Health and Human Services (HHS), the U.S. Department 
of Agriculture (USDA), and offices within the White House Executive 
Office of the President. A pesticide must be registered with the EPA 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
before it can be legally sold or distributed in the United States. 
During the registration process, EPA considers whether the pesticide 
will cause unreasonable adverse effects on people or the environment. 
Because resistance is considered an adverse effect under FIFRA, the 
U.S. government is working to develop a structured and coordinated 
approach to assess and manage these risks. EPA is seeking public 
comment on a concept document for a proposed framework and on potential 
solutions, research, or mitigation approaches to reduce the spread of 
AMR. The agencies will consider feedback in developing a proposed 
framework that will also be shared for public review and comment.

DATES: Submit your comments on or before November 13, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2023-0445, through the Federal eRulemaking 
Portal at 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, 
1201 Constitution Ave. NW, Washington, DC 20004; 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 soliciting public comment 
on a document that describes the concept for developing a proposed 
framework 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. EPA is also 
seeking feedback on research gaps and other information to help inform 
the risk assessment and mitigation processes. The concept document was 
developed in collaboration with the U.S. Department of Health and Human 
Services (HHS), the U.S. Department of Agriculture (USDA), and offices 
within the White House Executive Office of the President. A pesticide 
must be registered with the EPA under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) before it can be legally sold or 
distributed in the United States. During the registration process, EPA 
considers whether the pesticide will cause unreasonable adverse effects 
on people or the environment. Because resistance is considered an 
adverse effect under FIFRA, the U.S. government is working to develop a 
structured and coordinated approach to assess and manage these risks. 
EPA is seeking public comment on a concept document for a proposed 
framework and on potential solutions, research, or mitigation 
approaches to reduce the spread of AMR. The agencies will consider 
feedback in developing a proposed framework that will also be shared 
for public review and comment.

C. Why is the Agency taking this action?

    In the United States, more than 2.8 million antimicrobial-resistant 
infections occur each year, resulting in more than 35,000 annual 
deaths. Some antibacterial and antifungal pesticides used in 
agriculture as well as some pesticides used in other settings, belong 
to the same class as or share mechanisms of action with medically 
important antimicrobial drugs used in human and veterinary medicine. 
Recent evidence indicates that the use of some antifungal pesticides 
can select for resistant organisms that pose a potential risk to human 
and animal health. As new pesticides and uses are proposed, the 
potential exists for these pesticides to select for pathogenic bacteria 
or fungi that are resistant to medically important antimicrobial drugs, 
including both FDA-approved drugs and those still undergoing clinical 
trials.

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

[[Page 65999]]

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.

E. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI information to EPA through https://www.regulations.gov or email. 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 
part or all of 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 ``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'' (also referred to as 
the concept document), a copy of which is available in the docket. EPA 
is also requesting public comments on potential solutions, research, or 
mitigation approaches to reduce the spread of AMR, and is specifically 
seeking public comment on the following questions for the proposed 
framework:
     Is the concept for the proposed framework (see Figure 1 in 
the concept document) appropriately defined and clear to stakeholders?
     Are there specific types of pesticides that should be 
evaluated under the framework, either by class or function?
     What factors that should be considered in determining if a 
proposed pesticide use constitutes a potential risk to human or animal 
health due to AMR?
     How to determine which human and animal antimicrobial 
drugs should be considered `medically important' and how should this 
term be defined?
     What mitigation strategies are currently available to 
address the risk of AMR developing because of pesticide use?
    Comment is also requested on the list of research gaps that could 
help inform risk assessment and mitigation addressed in this framework, 
including agricultural methods or other processes that could minimize 
the potential for these pesticides to select for resistant organisms 
and strategies to prevent infection or colonization related to pathogen 
exposure, including:
     How do organisms that might have developed resistance by 
exposure to these pesticides come into contact with and cause illness 
in humans or animals (e.g., through direct contact, inhalation, 
ingestion, healthcare-associated transmission), and which human or 
animal populations are most affected (e.g., agricultural workers, 
persons handling compost, persons with immunocompromising conditions, 
persons living near treated fields, animals for food production, 
companion animals)?
     What are effective strategies to reduce the potential for 
these pesticides to select for antimicrobial-resistant bacteria and 
fungi? For example, which agricultural practices are effective in 
reducing the potential for these pesticides to select for AMR, 
including strategies to reduce the need for pesticide use and practices 
that reduce the likelihood that pesticide use will result in resistance 
emergence (e.g., crop rotations, specific pesticide formulations)?
     By which mechanisms do human or animal pathogenic bacteria 
and fungi spread through populations after becoming resistant through 
selection by these pesticides?
     What are the best approaches to determine the potential 
for pesticides to select for antimicrobial-resistant pathogens, and do 
chemical criteria exist that could help determine whether pesticides 
are more or less likely to pose health risks to humans or animals?
    Authority: 7 U.S.C. 136 et seq.

    Dated: September 21, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-20929 Filed 9-25-23; 8:45 am]
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