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.

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: 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 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 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.