EPA Seeks Public Comment on Proposed Amendment to Experimental Use Permit for Genetically Engineered Mosquitoes

For Release: August 31, 2021

EPA is seeking public comment on a proposed amendment to extend and expand an approved Experimental Use Permit (EUP). The EUP currently allows Oxitec Ltd. to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in Florida and Texas through April 2022. The proposed amendment would extend field testing in Florida by another 24 months on up to 6,240 acres and expand testing to California on up 84,600 acres.

This amendment is still being reviewed by EPA and has not yet been approved. Once EPA finishes reviewing the proposed amendment and public comments, EPA will make a decision about whether to extend and expand the EUP.

In May 2020, EPA granted Oxitec’s EUP after extensive evaluation of the best available science, consideration of public input, and consultation with technical experts at the U.S. Centers for Disease Control and Prevention (CDC).

Starting in late April 2021, Oxitec has been measuring how effective OX5034 genetically engineered mosquitoes are in suppressing Aedes aegypti mosquito populations in Florida. They release genetically engineered male mosquitoes that have a gene that makes a specific protein. This protein, as produced in female mosquitoes, prevents female offspring from surviving. The absence of female mosquito emergence in the release area results in mosquito population decline, and potentially, the reduction of vector pathogens that cause mosquito-borne illnesses such as the dengue, Zika and chikungunya viruses.

Like all pesticides, Oxitec's genetically engineered mosquitoes are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). To be approved for an EUP or registration under FIFRA, pesticides must be shown to not cause unreasonable adverse effects to humans or the environment. Data submitted by Oxitec have demonstrated that their genetically engineered mosquitoes meet the FIFRA approval standard.

The EUP contains significant protections, including weekly monitoring and sampling of the mosquito population in the treatment areas, that also enabled the agency to determine the product meets the FIFRA safety standard. Additionally, it's important to note that only the adult male genetically engineered mosquitoes will be present in the environment and they do not bite people, further supporting EPA's finding that the mosquitoes are not expected to present risks to human health.

If an unforeseen event occurs, EPA has maintained the right to cancel the EUP at any point during the 24-month period.

The comment period for the proposed amendment will be open for 30 days in docket EPA-HQ-OPP-2019-0274 at www.regulations.gov.

To learn more about the approval of Oxitec’s EUP, watch EPA's webinar with English or Spanish captions.