Environmental Assessment for Investigational Use of 'Aedes Aegypti' OX513A: In Support of a Proposed Field Trial of Genetically Engineered (GE) Male 'Ae. aegypti' Mosquitoes of the Line OX513A in Key Haven, Monroe County, Florida under an Investigational New Animal Drug Exemption [open pdf - 3MB]
"Oxitec Ltd. ('Oxitec') has developed a mosquito control program which is an adaptation of the Sterile Insect Technique (SIT), a methodology that has successfully controlled several insect species in different countries over the last 50 years using radiation based sterilization. The Oxitec mosquito control program involves the repeated controlled release of genetically engineered (GE) male 'Aedes aegypti' mosquitoes (line OX513A), expressing a conditional lethality trait and a fluorescent marker. The line was first constructed in 2002, and a publication about it was published in a peer-reviewed scientific journal in 2007 (Phuc et al. 2007). This line has been characterized for over 10 years. Male OX513A mosquitoes mate with the wild females of their own species only, leading to a reduction in the population of the local population of 'Ae. aegypti'. Male mosquitoes do not bite humans or animals and therefore are unable to transmit or vector viruses or other saliva constituents. Oxitec mosquitoes can be used in two ways: to reduce the 'Ae. aegypti' population in an area, and/or to prevent its recurrence once control in the area has been achieved. The purpose of this proposed investigational field trial is to evaluate the mating ability of released OX513A mosquitoes with local wild-type 'Ae. aegypti' females, to assess the survival of the resultant progeny in order to estimate mortality related to inheritance of the #OX513 recombinant DNA (rDNA) construct, and to determine the efficacy of sustained releases of OX513A mosquitoes for the suppression of a local population of 'Ae. aegypti' in the defined release area in the Florida Keys, specifically an area known as Key Haven, in Monroe County, which is within the jurisdiction of the Florida Keys Mosquito Control District for mosquito control."
U.S. Food & Drug Administration: http://www.fda.gov/