FDA’s Center for Veterinary Medicine is currently reviewing information in an Investigational New Animal Drug (INAD) file from Oxitec, Ltd., regarding the company’s genetically engineered mosquitoes. As part of the review, the FDA published for public comment a draft environmental assessment 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.
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 is reviewing information on the Oxitec mosquito in consultation with government experts from other agencies, including CDC and EPA. The public comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes closed on May 13, 2016. The FDA is thoroughly reviewing all public comments and information submitted before determining its next steps. Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA and determined whether it will finalize the EA and FONSI or prepare an Environmental Impact Statement.