65998 Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 

In lieu of electronic filing, you may 

submit a paper copy. Submissions sent 

via the U.S. Postal Service must be 

addressed to: Kimberly D. Bose, 

Secretary, Federal Energy Regulatory 

Commission, 888 First Street NE, Room 

1A, Washington, DC 20426. 

Submissions sent via any other carrier 

must be addressed to: Kimberly D. Bose, 

Secretary, Federal Energy Regulatory 

Commission, 12225 Wilkins Avenue, 

Rockville, Maryland 20852. 

The Commission’s Office of Public 

Participation (OPP) supports meaningful 

public engagement and participation in 

Commission proceedings. OPP can help 

members of the public, including 

landowners, environmental justice 

communities, Tribal members and 

others, access publicly available 

information and navigate Commission 

processes. For public inquiries and 

assistance with making filings such as 

interventions, comments, or requests for 

rehearing, the public is encouraged to 

contact OPP at (202) 502–6595 or OPP@

ferc.gov. 

Dated: September 20, 2023. 

Debbie-Anne A. Reese, 

Deputy Secretary. 

[FR Doc. 2023–20887 Filed 9–25–23; 8:45 am] 

BILLING CODE 6717–01–P 

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. 

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: jennings.susan@

epa.gov. 

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 


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Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 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-epadockets#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] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–11421–01–OA] 

Establishment of Historically Black 

Colleges and Universities (HBCUs) and 

Minority Serving Institutions (MSIs) 

Advisory Council 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice; establishment of the 

Historically Black Colleges and 

Universities and Minority Serving 

Institutions Advisory Council. 

SUMMARY: As required by the Federal 

Advisory Committee Act (FACA), the 

United States Environmental Protection 

Agency (EPA) is giving notice that it is 

establishing the Historically Black 

Colleges and Universities and Minority 

Serving Institutions Advisory Council. 

The purpose of this committee is to 

provide advice and recommendations to 

the EPA Administrator on critical policy 

and technical issues to advance equity 

in economic and social opportunities for 

all Americans and strengthen the 

capacity of HBCUs and MSIs to provide 

the highest-quality education, 

participate in and benefit from federal 

programs, and support key 

Administration policies. The EPA has 

determined that this federal advisory 

committee is necessary and in the 

public interest to provide critical advice 

and recommendations to assist the EPA 

in increasing outreach to 

underrepresented and underserved 

communities by developing a stronger 

partnership with HBCUs and MSIs. 

FOR FURTHER INFORMATION CONTACT: 

Pradnya Bhandari, Designated Federal 

Officer, U.S. EPA, 1200 Pennsylvania 

Avenue NW (Mail code 1448K), 

Washington, DC 20460, at 202–564– 

0381 or by email to bhandari.pradnya@

epa.gov. 

SUPPLEMENTARY INFORMATION: The 

Historically Black Colleges and 

Universities and Minority Serving 

Institutions Advisory Council will be 

established for a two-year period. 

Copies of the committee charter will be 

filed with the appropriate congressional 

committees and the Library of Congress. 

Kathryn Jakob, 

Director, Office of Public Engagement. 

[FR Doc. 2023–20878 Filed 9–25–23; 8:45 am] 

BILLING CODE 6560–50–P 


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