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FDA finds 'no significant impacts' of genetically altered mosquitoes, public comment period opens

The U.S. Food and Drug Administration has preliminarily found that releasing genetically modified mosquitoes in Key Haven to lessen one species' population "will not result in significant impacts on the environment."

The finding is to be published in the Federal Register Monday and that will open a 30-day comment period for the public. From there, the FDA will further review the proposal in consultation with other agencies, including the Centers for Disease Control and Prevention and the Environmental Protection Agency.

British firm Oxitec has been working on the plan with the Florida Keys Mosquito Control District since 2011.

The target bug is the Aedes aegypti mosquito, which carries dengue fever and the Zika virus, among other things. They are illnesses that cause body pain and flu-like symptoms. Zika also might be a contributor to birth defects.

Oxitec's OX513A mosquito would have DNA that would not allow the offspring of Aedes aegypti to reproduce, cutting down the population.

"This is strictly through the FDA. This is part of their review process so after public comment, the FDA will take back all of the comments and continue their review," Mosquito Control spokeswoman Beth Ranson said.

Comments can be made at www.regulations.gov. Once there, type in FDA-2014-N-2235 in the search box to make add your comments on the plan.

Those who do not have Internet access or would rather comment on paper can mail their comments to the Division of Dockets Management HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Written submissions must include "Docket No. FDA-2014-N-2235 for Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes."

Mailed-in comments will be viewable at www.regulations.gov unless they're marked as confidential submissions.

Ranson said a link to the FDA to comment on Mosquito Control's plans should be on the district's website, www.keysmosquito.org, Monday.

"This is just the next step in the approval process," Ranson said. "This doesn't mean that it's approved for release."

Oxitec built a rearing facility in the Mosquito Control building in Marathon in November 2014. Key Haven, just outside of Key West, has been selected for trial runs should Oxitec get approval.

The FDA notes Oxitec has released the OX513A mosquito in Brazil, the Cayman Islands, Panama and Malaysia. In 2014, Oxitec reported a 96 percent suppression rate of dengue-carrying Aedes aegypti mosquitoes in Mandacaru, Brazil. Brazil is ground zero for Zika but it has spread to other countries.

The Keys saw 27 cases of dengue in 2009 and 65 in 2010 but none since. There have been no reported cases of Zika in the Keys.

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