Investigational Use of Oxitec OX513A Mosquitoes; Preliminary Finding of No Significant Impact
FDA is announcing that a draft EA and preliminary FONSI, in support of a proposed investigational release (i.e., field trial) of OX513A Aedes aegypti GE mosquitoes (OX513A mosquitoes), as part of an existing mosquito control program in Key Haven, FL, are being made available for public comment. The OX513A is a strain of Ae. aegypti mosquito whose recombinant DNA (rDNA) construct encodes a conditional lethality trait such that the offspring of the matings of male OX513A mosquitoes and wild type Ae. aegypti do not survive to adulthood. The intended result is a decrease in the overall population of Ae. aegypti in the environment. Only male OX513A mosquitoes are intended to be released.
To encourage public transparency, and in compliance with 21 CFR 25.51(b)(3), the Agency is placing Oxitec Ltd.’s draft EA and preliminary FONSI that are the subject of this notice on public display at the Division of Dockets Management (see DATES and ADDRESSES) for public review and comment for 30 days. Oxitec Ltd. prepared the draft EA. The preliminary FONSI is based upon Oxitec Ltd.’s draft EA. FDA is considering the draft EA and tentatively agrees with its conclusion that conduct of this trial will result in no significant impacts on the environment. If nothing changes FDA’s tentative determination, FDA will prepare and release its own revised, final EA and final FONSI. The Agency intends to take comments received under advisement in determining whether to prepare a revised, final EA and FONSI. If FDA does not agree with the preliminary conclusion that conduct of this trial will result in no significant impacts on the environment, it will prepare an environmental impact statement.