Public Comment Invited Regarding Draft Environmental Assessment for Genetically Engineered Mosquito

Release March 11, 2016, by the FDA, Center for Veterinary Medicine

The FDA is releasing, for public comment, a draft environmental assessment (EA) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya.

The National Environmental Policy Act (NEPA) requires federal agencies to assess the environmental impacts of certain actions. Pursuant to FDA regulations, sponsors opening an Investigational New Animal Drug (INAD) file must submit either a draft EA or a claim of categorical exclusion from the EA requirement.

The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft EA’s conclusion that the field trial of such GE 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 EA, and subsequently has issued either a final EA and FONSI or an environmental impact statement.

The FDA is accepting public comments on the draft EA and preliminary FONSI for 30 days from the date of publication in the Federal Register. To submit your comments electronically to the docket, go to www.regulations.gov. While comments are welcome at any time, you should submit them by the closing date (shown  now as April 13, 2016) to ensure FDA considers your comments.

The public may submit their comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-2235 on each page of your written comments.

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

These links, included with the FDA call for comment, are to Additional Information.

• Oxitec Mosquito
• Oxitec Mosquito – Draft Environmental Assessment PDF
• Oxitec Mosquito – Preliminary Finding of No Significant Impact PDF
• Notice of Availability; Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes

Ed. Notes:

The Food and Drug Administration is online at www.fda.gov. The above release came from their Animal & Veterinary notices.

Oxitec is a biotech company based in the UK. On this Oxitec GM mosquito webpage, they list the insects — under their “Products” link — that they are genetically modifying. 

Florida-related mosquito information is posted on the Florida Department of Agriculture and Consumer Services website (www.freshfromflorida.com). To go to the mosquito-related page, click here.