March 14, 2016

FDA Announces Comment Period for GMO Mosquito Test Plan

On March 11, the Food and Drug Administration (FDA) released for public comment the draft environmental assessment submitted by Oxitec for its genetically engineered Aedes aegypti mosquitoes. The assessment, required under the National Environmental Policy Act, looks at the potential environmental effects of a field trial of the mosquitos in Key Haven, Florida.

At the same time FDA released the assessment, the agency issued a preliminary finding of no significant impact (FONSI) for the field test, which concurs with Oxitec’s environmental assessment.

“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 [environmental assessment] and FONSI or an environmental impact statement,” the agency said in a statement.

The genetically modified mosquitoes could be used to fight human viral diseases like Zika, dengue, yellow fever and chikungunya, but concerns have been raised over their potential ecological impact.

The Synthetic Biology Project recently released a report looking at the regulatory hurdles facing Oxitec's genetically engineered mosquitos. The report, along with other case studies and a review of existing statutes, can be found here.

The project has also developed a research agenda looking at the ecological impacts of synthetic biology applications in the wild.