The agency’s Center for Veterinary Medicine (FDA-CVM) released in the Federal Register a preliminary finding of no significant impact (FONSI) on OX513A for an investigational trial in the Florida Keys.
A field trial of Oxitec’s genetically engineered OX513A mosquitoes in Key Haven, Florida, is now confirmed to not to result in a significant impact on the environment.
Oxitec CEO Hadyn Parry said: "The Aedes aegypti mosquito represents a significant threat to human health, and in many countries has been spreading Zika, dengue and chikungunya viruses.
"This mosquito is non-native to the US and difficult to control, with the best available methods only able to reduce the population by up to 50%, which is simply not enough. We look forward to this proposed trial and the potential to protect people from Aedes aegypti and the diseases it spreads."
The proposed trial aims to identify the efficacy of Oxitec’s self-limiting mosquitoes for the control of the local population of Aedes aegypti in Key Haven, Monroe County, Florida.
The company’s self-limiting mosquitoes have been genetically engineered so that their offspring die prior to reaching adulthood.
According to the company, male Oxitec mosquitoes, which do not bite or spread disease, are released to mate with wild female Aedes aegypti so that their offspring die, reducing the population.
The population of Aedes aegypti was reduced by over 90% during efficacy trials in Brazil, Panama, and the Cayman Islands.