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.
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)