As an environmental attorney, I am often asked to evaluate the legal processes surrounding emerging technologies that intersect with protecting human health and the environment. Few issues illustrate this intersection more vividly than the U.S. Environmental Protection Agency’s latest announcement concerning genetically engineered mosquitoes for mosquito control.

This is a significant environmental matter.

For those unaware, mosquitoes kill more humans than any other creature, including other animals and even humans themselves. They are the deadliest animals in the world.

Malaria, transmitted by mosquitoes, continues to be a leading cause of preventable illness and death in the world, resulting in nearly 263,000,000 cases and 597,100 deaths across 83 countries in 2023. In 2023, for the first time in two decades, the United States experienced cases of locally acquired mosquito transmitted malaria, including cases in Florida, Texas, Maryland, and Arkansas.

On August 21, 2025, EPA began soliciting public comment on a suite of scientific and policy documents that the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel will publicly review. This panel review is scheduled for November 3 – 5, 2025, and it marks a pivotal step in EPA’s evolving framework for regulating biotechnology products that fall under FIFRA’s broad definition of “pesticide.”

The Legal and Regulatory Framework

At its core, this action is grounded in the authority of FIFRA, a statute enacted in 1947 and amended over the decades to ensure that all pesticides distributed or sold in the United States do not pose unreasonable adverse effects on human health or the environment. Importantly, FIFRA’s scope is not limited to chemical sprays; it extends to biological controls and novel biotechnologies such as genetically engineered mosquitoes. These organisms are considered pesticidal because their genetic modifications are intended to suppress mosquito populations, thereby reducing the transmission of malaria and other mosquito borne diseases.

EPA has long relied on the FIFRA SAP as a mechanism for independent scientific peer review. Established in 1975, the SAP is comprised of leading experts nominated through the National Institutes of Health and the National Science Foundation, with additional scientists available on an ad hoc basis through the Science Review Board. The SAP’s statutory role is to advise EPA on complex scientific matters to improve the robustness of risk assessments and ultimately to support sound regulatory decisions. This scientific review focuses on whether novel proteins are present in the saliva of female genetically engineered mosquitoes, a key consideration because females, unlike males, bite humans.

What is at Issue

Mosquito borne diseases remain a serious public health threat across the globe including in the U.S., and developers are increasingly turning to genetic engineering to reduce populations of disease carrying species. Unlike chemical pesticides, genetically engineered mosquitoes are a “living pesticide.” They work by introducing males with engineered traits that cause reproductive incompatibility, thereby suppressing populations over time.

Genetically engineered mosquito trials in Africa show limited promising early results, though they are still under evaluation and haven’t been fully deployed as large scale control programs. One major obstacle is that there are over 3,500 species of mosquito (.. most do not bite humans) with more than 175 species identified in the U.S.; genetically modifying one species in one geographic area does not impact another.

The Science

The central scientific question is deceptively simple: Do genetically engineered female mosquitoes produce novel proteins in their saliva that could pose new risks to humans if transmitted through bites? To answer this, EPA has prepared a draft white paper, charge questions, and a draft memorandum for developers of genetically engineered mosquitoes. These documents outline both design considerations (to minimize the likelihood that engineered proteins would be expressed in mosquito saliva) and recommended methodologies for empirically verifying the absence of such proteins.

The risk assessment hinges on the traditional definition of “risk” as the product of hazard and exposure. If novel proteins are absent from mosquito saliva, the exposure pathway for humans is effectively eliminated, and the risk is substantially reduced. However, if proteins are present, even in small amounts, EPA must evaluate whether their biochemical properties pose potential hazards. The SAP’s deliberations will help shape the scientific consensus on how to conduct these analyses in a manner that is rigorous, repeatable, and sufficient to satisfy FIFRA’s statutory mandate.

Public Participation and Key Dates

EPA has emphasized transparency and public participation throughout this process. Stakeholders, including industry developers, academic researchers, nongovernmental organizations, and concerned citizens, will have multiple opportunities to weigh in. Written comments on the documents are due by September 22, 2025, and requests to provide oral remarks during the meeting must be submitted by October 27, 2025, at noon Eastern Time. Oral comments will be limited to five minutes, though EPA encourages the submission of written versions and supporting materials by October 30, 2025, to ensure panel members have adequate time to review them.

The virtual meeting itself, held via Zoomgov.com and teleconference from November 3 – 5, 2025, will allow the public not only to observe but also, where registered, to participate directly in the dialogue. EPA has also set deadlines for accommodation requests (October 24, 2025) and for observers who wish to register without providing comments (November 5, 2025). These procedural safeguards ensure that all interested parties, from technology developers to environmental justice advocates, can meaningfully engage in the process.

Broader Policy Implications

This proceeding is about far more than one product or one company’s application. It represents a test case for how EPA will regulate genetically engineered insects going forward, at a time when vector borne diseases like dengue, Zika, and West Nile virus remain persistent threats in the U.S. If the Agency, guided by SAP recommendations, establishes clear and scientifically sound methodologies for assessing protein expression in mosquito saliva, it will provide regulatory certainty to developers while safeguarding public health.

From a legal perspective, this process also highlights the adaptability of FIFRA to novel technologies. Though the statute was enacted decades before genetic engineering, its broad definitions and reliance on case by case scientific review allow EPA to extend its protective framework to cutting edge biotechnology. This flexibility is critical: it balances the potential benefits of genetically engineered mosquitoes, reduced reliance on chemical pesticides, targeted species suppression, and potential declines in disease transmission, against the need to prevent unforeseen human health risks.

Conclusion

EPA’s ongoing review of genetically engineered mosquitoes illustrates the challenges and opportunities of regulating biotechnology under existing environmental law frameworks. Convening the FIFRA Scientific Advisory Panel, the Agency is not only subjecting its draft guidance to independent scrutiny but also opening the door for meaningful public participation in a consequential environmental matter.

The outcome of this proceeding will have lasting implications. If the SAP affirms EPA’s draft methodologies, we may soon see a pathway toward broader deployment of genetically engineered mosquitoes as a tool for public health protection. Conversely, if uncertainties remain, the Agency may require additional testing or impose new conditions on product registrations. Either way, this process underscores the importance of rigorous science, robust public input, and the continuing evolution of environmental law.

For stakeholders across the spectrum, from industry innovators and environmental advocates to public health practitioners and those concerned with protecting the planet, this is a moment to engage. We know a thing or two about mosquito control, and if we can assist you in commenting or otherwise, do not hesitate to reach out to us. Make no mistake, the decisions made here will shape not only the future of mosquito control but also the role of emerging genetic technologies in environmental protection.

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