Federal Register Date: 2026-03-27
Original Source: Read Full Notice
This notice concerns an application submitted by the United States Department of Agriculture (USDA) to the Environmental Protection Agency (EPA) for the registration of a new pesticide product. This product contains an unregistered pesticide, specifically NovoFly male-only genetically engineered (GE) New World screwworm (NWS). The intended use of this pesticide is within USDA’s Sterile Insect Technique (SIT) programs.
The New World screwworm (NWS) is a parasitic insect that infests livestock and other warm-blooded animals, causing significant economic damage and animal suffering. The Sterile Insect Technique (SIT) is a biological control method that involves releasing sterile male insects into the wild to mate with wild females. These matings do not produce offspring, leading to a reduction in the pest population over time.
The NovoFly product utilizes genetically engineered NWS males. These males are engineered to be sterile and, importantly, to only produce male offspring. This is intended to enhance the effectiveness of the SIT program by preventing the inadvertent introduction of fertile females into the environment, which could exacerbate the problem. The application seeks to register this product under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which governs the registration of pesticide products.
In addition to the Section 3 registration application, the EPA also received a Section 18 quarantine emergency exemption application from the USDA. This application requests the use of the same NovoFly pesticide to manage and suppress the NWS population. The primary goal of this emergency use is to prevent the pest from spreading further northward from Mexico towards the United States. Section 18 of FIFRA allows the EPA to grant emergency exemptions for the use of unregistered pesticides or registered pesticides for unregistered uses, under specific emergency conditions. These exemptions are typically granted for a limited time and geographic area to address urgent pest control needs.
The EPA recognizes the urgent nature of the emergency situation presented by the potential spread of NWS. Given the limited time available to authorize the Section 18 quarantine emergency exemption request, and considering the related Section 3 product registration application under review for the same use, the EPA has decided to waive the comment period typically associated with emergency exemption requests. This decision is intended to expedite the process and allow for a rapid response to the potential threat posed by the NWS.
However, the EPA emphasizes its commitment to transparency and public participation. While the comment period for the emergency exemption request is being waived, the Agency is actively soliciting public comment in conjunction with the application for Section 3 product registration of NovoFly. This allows the public to provide input on the potential risks and benefits associated with the use of this genetically engineered pesticide, even as the emergency situation is being addressed.
The EPA is requesting that interested parties submit comments on the Section 3 product registration application for NovoFly. These comments should address any concerns or support regarding the potential environmental and human health impacts of the product, as well as its effectiveness in controlling the NWS population. All comments received will be carefully considered by the EPA as part of its review process for the Section 3 registration application. The agency will evaluate the data submitted by the applicant, as well as any information provided by the public, to determine whether the pesticide product meets the safety standards required for registration under FIFRA. This includes assessing the potential risks to non-target organisms, water quality, and human health. The EPA’s decision on the Section 3 registration application will be based on a thorough scientific evaluation of all available information.
