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FDA finds "no significant impact" of genetically modified mosquito on health or environment

A field trial could follow the results of a local referendum in November

CNN  — 

It’s another win for the GMO mosquito.

After months of reviewing public comments to its draft environmental impact study, the Food and Drug Administration announced today that it is officially giving OX513A, a genetically modified male mosquito developed by British company, Oxitec, a clean bill of health. The decision gives the federal green light for the use of the mosquito in a field trial this fall in a small Florida neighborhood.

“We’re really pleased to announce the FDA finished their review and has found no significant impact of the release of our mosquito on human health or the environment,” Oxitec CEO Hadyn Parry said. “This is especially timely, given the recent finding of Zika transmission by local mosquitoes in a Miami neighborhood.”

OX513A is a male Aedes aegypti mosquito, the primary species that carries the Zika virus. He is genetically engineered to pass along a lethal gene to wild females that makes the females’ offspring die. The gene creates a protein that interferes with cell activity, killing the mosquito before it can reach adulthood.

The field trial in Key Haven, Florida, is designed to test how well OX513A controls the local population of Aedes aegypti. Key Haven is a small community of about 475 homes on Raccoon Key, about a mile east of the island of Key West.

Oxitec says it expects the same results it has had in field trials in Brazil, Panama and the Cayman Islands.

“Our studies show we can reduce the Aedes aegypti population by 90% over six months and keep it there by releasing small numbers of males after that,” Parry said. “And that is very cost-effective compared to pesticides.”

A successful field trial is required before OX513A can be sold commercially in the United States.

Though the FDA decision paves the way for Oxitec to begin production of the genetically altered male mosquitoes in its facility in Marathon, Florida, Parry said his company plans to wait for the results of a local referendum scheduled for November.

“The decision on when to start the trial rests with the local mosquito control board,” he said. “They wanted to get out and get people’s views. It is a consultation, and they are not bound by the results.”

“We forced our board to go into an election,” said Mila de Mier, a vocal opponent of the GMO mosquito who lives near Key Haven. “Because so far, consent has not been asked or given by the local population.”

During the November referendum, Key Haven residents will be allowed to vote twice: once to determine whether they want to allow the mosquito to be released into their neighborhood and again as part of a countywide vote. The countywide vote will determine whether another neighborhood in the Keys might be willing to participate.

Opponents are confident that voters will say no.

“People don’t want to be guinea pigs,” Mier said. “There has been no acceptance from people who live in the Key Haven community. In fact, 85% are against it. And that’s why we need this election.”

However, Parry cited a national Purdue University study that found 78% of respondents would support the introduction of genetically modified mosquitoes into the United States to curb the spread of Zika.

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    If the Keys referendum receives a “no” vote, Parry said, starting over in a new location would not be onerous.

    “We have the FDA stamp of approval,” he said, “and we have had a lot of inquires from various state and local officials who are trying to get up to speed on our technology and how it might help them in their efforts.”

    Parry said one of the interested parties was Florida Gov. Rick Scott’s team.

    A square-mile area of Miami-Dade County is the first site in the continental United States where Zika has been transmitted by infected mosquitoes. A total of 16 people have gotten the virus from mosquitoes there since June 15.