US EPA finalizes framework for interagency collaboration on resistance risks associated with antibacterial and antifungal pesticides

The U.S. Environmental Protection Agency (EPA) finalized its framework for expanding federal collaboration on the review of antibacterial and antifungal pesticides. To develop the framework, EPA coordinated with the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), under the oversight of the White House Office of Science and Technology Policy. The framework establishes a process for EPA to consider input from the other federal agencies when evaluating whether antibacterial or antifungal pesticides might result in the development or spread of resistance and reduce the effectiveness of some human and animal antibacterial and antifungal drugs.

″This framework will strengthen the shared goals of EPA, HHS, USDA, and the White House in protecting relevant human and animal drugs while ensuring growers can continue to have access to important tools to protect their crops from fungal and bacterial diseases,″ said the Director of EPA’s Office of Pesticide Programs Ed Messina.

″The Biden-Harris Administration is committed to protecting public health and the environment. The rise of antimicrobial resistance poses a growing global health challenge,″ said Deputy Assistant to the President for the Cancer Moonshot and White House Office of Science and Technology Policy Deputy Director for Health Outcomes Danielle Carnival. ″Integrating the best available human, plant, and environmental science in future decision making about how and what antibacterial and antifungal pesticides we use is an important step forward to improving health outcomes for all Americans.″

Through the framework, EPA aims to recognize the benefits of these pesticides to agriculture while minimizing their impact on public and animal health and considering a One Health approach. One Health is a multidisciplinary approach to improve health outcomes by analyzing linkages between humans, animals, and the global environment.

Background

Many farmers use pesticides to treat bacterial and fungal diseases that affect their crops. If left uncontrolled, these diseases can be extremely damaging and sometimes threaten entire industries. Fungal diseases, such as apple scab, various rusts, and gray mold, and bacterial diseases, such as fire blight, can reduce crop yield or quality. Other diseases, such as citrus greening, can take entire orchards out of production if left uncontrolled.

There is emerging information that the use of these pesticides may also result in the development of antifungal or antibacterial resistance, reducing the effectiveness of some human and animal antibacterial and antifungal drugs. This is because some of these pesticides share characteristics or modes of action with antibacterial and antifungal drugs. For instance, if a strain of bacteria or fungi becomes resistant to a pesticide, that strain may also become resistant to human or animal drugs that share similar characteristics with the pesticide. As a result, a drug used to treat a bacterial or fungal infection in a human or animal may not work well against those resistant bacteria or fungi.

In Sept 2023, EPA released a concept note to gather initial feedback on the proposed framework. In July 2024, EPA released a draft framework for a 30-day public comment period. Fourteen commenters representing a diverse group of stakeholders including researchers, industry groups, public health groups, veterinary groups, and an individual citizen, responded to EPA’s request for public comment on the draft framework. EPA has responded to the individual comments in the document ″EPA Responses to Public Comments on FR 2024-14493". Changes in the final framework based on the feedback received include clarification of the types of pesticides impacted by the framework, further explanation of the roles of relevant federal agencies, and additional information on EPA’s efforts to make this process as transparent as possible. The final document provides further perspective on the framework’s role in EPA’s evaluation of antifungal and antibacterial pesticides and how EPA will continue advancing its regulatory process for assessing the potential antibacterial and antifungal resistance risks from pesticide use.

Final Framework

This final framework describes the EPA's plan to establish and chair a working group with experts from across the federal government, including the Centers for Disease Control and Prevention, the Food and Drug Administration, and USDA. This group--the Interagency Drug and Pesticide Resistance and Efficacy Workgroup (IDPREW)--will convene when there is information about a pesticide that has the potential to cause resistance to a medically important human or animal drug. When EPA drafts risk assessments for antibacterial and antifungal pesticides covered by the framework, it expects to consult with the IDPREW to seek input on the draft assessments. The IDPREW will not make recommendations to grant or deny specific pesticide applications. EPA and federal partners also have established a memorandum of understanding to facilitate information sharing for the IDPREW.

Substantial uncertainties exist about the risks to human and animal health from using pesticides that may select for resistance. The framework also contains a research agenda (Appendix A) that lists the main uncertainties that impact EPA’s confidence in assessing the resistance risks from antibacterial and antifungal pesticide use. This list highlights areas for scientific development that, if pursued, would help 1) inform assessments of the risk to the efficacy of human and animal antibacterial and antifungal drugs posed by certain antibacterial or antifungal pesticides and 2) clarify how to mitigate these risks.

The final framework and supporting documents will be available in the docket EPA-HQ-OPP-2023-0445 at www.regulations.gov tomorrow, October 10, 2024. To read them now, please visit EPA's website.

Read EPA's Final Framework