FDA Publishes Final Finding of No Significant Impact and Environmental Assessment on Oxitec’s Self-limiting Mosquito
Oxford, UK, 5 August 2016 - 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.”
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