FDA announces comment period on genetically modified mosquitoes
March 11, 2016
The Food and Drug Administration announced today a 30-day public comment period on a draft environmental assessment submitted by Oxitec Ltd. that assesses the potential environmental impacts of a field trial of the company's genetically engineered Aedes aegypti mosquitoes (OX513A) in Key Haven, Fla.
Ae. aegypti is known to transmit potentially debilitating human viral diseases – including Zika, dengue, yellow fever, and chikungunya. The genetically engineered mosquitoes die before maturing.
Scientists believe the genetically engineered mosquitoes could lessen the impact of Zika, but some activists have charged that the genetically engineered mosquitoes spread the disease.
The National Environmental Policy Act requires that sponsors opening an Investigational New Animal Drug file must submit either a draft environmental assessment or a claim of categorical exclusion from the environmental assessment requirement.
The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft environmental assessment conclusion that the field trial of such genetically engineered mosquitoes will not result in significant impacts on the environment.
Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft environmental assessment and subsequently has issued either a final assessment and FONSI or an environmental impact statement, FDA said.
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