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The US Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) today published a final finding of no significant impact (FONSI) and final environmental assessment (EA) on Oxitec's self-limiting OX513A Aedes aegypti mosquito for an investigational trial in the Florida Keys. The finding concludes that a field trial of the Company's genetically engineered (GE) OX513A mosquitoes in Key Haven, Florida, will not result in a significant impact on the environment.
The publication of the final FONSI and EA follows an FDA-led evaluation of potential impacts on health and the environment of the proposed trial. This culminated in the publication of a preliminary FONSI in March 2016, after which there was a period of public comment. These public comments were reviewed by the FDA-led team before the final documents were published today.
Oxitec's Chief Executive Officer Hadyn Parry said, "We've been developing this approach for many years, and from these results we are convinced that our solution is both highly effective and has sound environmental credentials. We're delighted with the announcement today that the FDA, after their extensive review of our dossier and thousands of public comments for a trial in the Florida Keys, have published their final view that this will not have a significant impact on the environment. We are now looking forward to working with the community in the Florida Keys moving forward."
The purpose of the proposed trial is to determine the efficacy of Oxitec's self-limiting mosquitoes for the control of the local population of Aedes aegypti in Key Haven, Monroe County, Florida.
Oxitec's self-limiting mosquitoes have been genetically engineered so that their offspring die before reaching adulthood. 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. Efficacy trials in Brazil, Panama, and the Cayman Islands have tested this approach, and in each of these trials the population of Aedes aegypti was reduced by more than 90% – an exceptional level of control compared to conventional methods, such as insecticides.
The FDA review team consisted of experts from the Center for Veterinary Medicine (CVM), the Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency (EPA). The FDA led an extensive review of evidence from trials in urban environments performed in Brazil and the Cayman Islands since 2009, and data from numerous safety studies, site inspections and independent experts.
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