Oxitec, Ltd. has an open Investigational New Animal Drug file with the FDA’s Center for Veterinary Medicine regarding the company’s genetically engineered mosquitoes. The FDA is reviewing information on the Oxitec mosquito in consultation with government experts from other agencies, including CDC and EPA.
As part of the review, the FDA published for public comment a draft Environmental Assessment (EA) submitted by Oxitec, Ltd. that assesses the potential environmental impacts of conducting a field trial in Key Haven, Florida and a preliminary Finding of No Significant Impact (FONSI). On August 5, 2016, after considering thousands of public comments, the FDA released a final EA and FONSI agreeing with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.
FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.
Oxitec has produced a genetically engineered line of the mosquito Aedes aegypti (OX513A) with the intent of suppressing the population of that mosquito at the release site(s). Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever, and chikungunya and has been found in some U.S. states, but is most prevalent in the South. Open field trials of the OX513A genetically engineered mosquito have been conducted in Brazil, the Cayman Islands, Panama, and Malaysia.
On January 18, 2017, FDA released for a 30-day public comment period Draft Guidance for Industry #236, Regulation of Mosquito-Related Products, that clarifies which mosquito-related products FDA regulates and which such products EPA regulates. This draft guidance is consistent with the FDA’s commitments outlined in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy; released in September 2016), which sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology. As part of the Strategy, the FDA and EPA committed to considering mechanisms that would enable EPA to regulate certain mosquito-related products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when the developer claims they are intended to control mosquito population levels, and the FDA to regulate them under the FD&C Act when the developer makes other claims, such as a disease prevention claim.
The draft guidance was developed in coordination with EPA and describes the FDA’s understanding that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes are not “drugs” under the FD&C Act, and, when the guidance is finalized, will be regulated by EPA under FIFRA. Under the draft guidance, FDA would continue to have jurisdiction over mosquito-related products that meet the FD&C Act drug definition, such as those intended to prevent, treat, or cure a disease.
FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito Oxitec Mosquito - Final Environmental Assessment(PDF - 3MB) Oxitec Mosquito - Appendices to Final Environmental Assessment(PDF - 28.3MB)
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Oxitec Mosquito - Finding of No Significant Impact(PDF - 198KB) Oxitec Mosquito - Draft Environmental Assessment(PDF - 33.3MB) Oxitec Mosquito - Preliminary Finding of No Significant Impact(PDF - 147KB)
- Draft Guidance for Industry #236, Regulation of Mosquito-Related Products (PDF - 109KB)
- CVM Update: FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products