Feedback Requested on Structure and Scope for Proposed Framework to Strengthen Assessment of Antimicrobial-resistance Risks Associated with Pesticide Use

Released on September 26, 2023

Through a U.S. government interagency process, the U.S. Environmental Protection Agency (EPA), 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 Executive Office of the President, have published a concept note. The concept note is the first step in creating a framework to improve how EPA assesses the potential risks to human and animal health from pesticide uses that could result in antimicrobial resistance that compromises the effectiveness of medically important antibacterial and antifungal drugs.

The concept note solicits stakeholder input on the proposed structure for the framework and on potential solutions, research, or mitigation approaches to reduce the spread of resistance. Feedback will then be incorporated, as appropriate, into the draft framework and the final framework, which will be issued at a later date. Comments can be provided for the next 45 days by searching docket ID EPA-HQ-OPP-2023-0445 at www.regulations.gov.

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 even threaten entire industries. For example, according to USDA, a bacterial disease known as “citrus greening” has spread across Florida since 2005. It has devastated the Florida citrus industry by reducing citrus production by 75 percent and more than doubling the cost of production.

While antibacterial and antifungal pesticides can be effective at managing these diseases on crops, there is emerging evidence that in rare cases, the use of these pesticides can reduce the effectiveness of some human and animal antibacterial and antifungal drugs. This is because some antibacterial and antifungal pesticides share characteristics with antibacterial and antifungal drugs. Thus, if a strain of bacteria or fungi becomes “resistant” to a pesticide, that strain will also be resistant to human or animal drugs that share similar characteristics with the pesticide. As a result, a drug that would normally be used to treat a bacterial or fungal infection may not work well against those resistant bacteria or fungi.

For example, farmers sometimes apply antifungal pesticides to protect their crops from fungal diseases. However, these antifungal pesticides can make strains of a specific fungi (known as Aspergillus fumigatus) resistant. When a human breathes in this resistant strain of fungi, they can develop a fungal infection known as aspergillosis. Because the infection is caused by a strain of Aspergillus fumigatus that is resistant to antifungal pesticides, the infection will also be resistant to antifungal drugs that share characteristics with those antifungal pesticides. As a result, the antifungal drug that doctors would normally prescribe to treat aspergillosis may no longer be effective. Alternative treatments, if they are even available, may not be as effective or have worse adverse side effects.

Concept Note

Antimicrobial resistance is an urgent, global public health threat, and preserving the effectiveness of antibacterial and antifungal drugs is essential to protecting the health of humans, animals, and plants. The proposed framework described in the concept note will expand EPA’s current process for assessing the risk that antibacterial or antifungal pesticides may pose to the effectiveness of human and animal antibacterial and antifungal drugs when EPA evaluates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Currently the concept note structures the framework into the following components:

• Resistance Characterization: EPA would evaluate whether a proposed pesticide use could compromise the effectiveness of a medically important human or animal drug. If the resistance characterization identifies such a concern, EPA would conduct a qualitative risk assessment.
• Risk Assessment: EPA would estimate the probability that the proposed use of the antibacterial or antifungal pesticide may result in resistant bacteria or fungi. EPA would also estimate the likelihood of humans or animals being exposed to the newly resistant bacteria or fungi. This assessment would determine the overall risk for resistance associated with the proposed pesticide’s use.
• Risk Management: If the risk assessment identifies areas of concern, the results of the risk assessment are evaluated along with other considerations to decide whether risk reduction measures are needed and, if so, which ones.

Soliciting Comment

Comments on the concept note can be provided for the next 45 days by searching docket ID EPA-HQ-OPP-2023-0445 at www.regulations.gov. EPA and federal partners are specifically soliciting feedback on:

• The clarity of the proposed structure for the framework.
• The types of pesticides that should be evaluated under the framework (by class or function).
• The factors that should be considered in determining if a proposed pesticide use constitutes a potential risk to human or animal health due to resistance (e.g., are existing laboratory studies applicable to field situations or would field studies be needed).
• The process for determining which human and animal antibacterial and antifungal drugs should be considered “medically important” and how this term should be defined.
• The mitigation strategies that are currently available to address any potential risk of antimicrobial resistance developing due to pesticide use.
• A list of knowledge gaps provided in the concept note.

After receiving and reviewing public input, feedback will be incorporated as appropriate and a draft framework will be shared. The public will have the opportunity to comment on the draft framework before the final framework is published.

For more information, read the concept note or visit EPA’s webpage.