FDA approves plan to release genetically engineered mosquitoes in Florida Keys despite inadequate safety assessment

WASHINGTON— Last week the U.S. Food and Drug Administration (FDA) approved the release of genetically engineered (GE) mosquitoes in the Florida Keys without a thorough review of the risks associated with such a release. This first-of–its-kind release was approved by the FDA despite widespread public outcry and a weak environmental assessment.

According to the Center for Food Safety, Food and Water Watch, Friends of the Earth and the Florida Keys Environmental Coalition, this release should warrant a full environmental impact statement. Biotech and pest control company Oxitec urged the FDA to speed approval of a trial involving widespread release of millions of GE mosquitoes in the Florida community of Key Haven. Oxitec’s application to the FDA does not claim that the release of the GE mosquitoes would cause the reduction of diseases such as Dengue or Zika. More than 250,000 people submitted comments to criticize the FDA’s review of Oxitec’s planned release of the GE mosquitoes in Key Haven.

The FDA’s formal review of the company’s application and environmental assessment fails to evaluate key issues surrounding the releases, including safety to human health, potential for the experimental mosquitos to move out of testing areas, and whether or not large numbers of the GE mosquitoes will actually reduce the spread of diseases like West Nile, Dengue or Zika. The FDA bypassed the normal process of responding to the comments submitted to its formal docket which closed May 13 of this year. The FDA also changed its policy in its guidance document on approval of GE animals/insects so that public hearings are no longer required. These actions suggest that politics, not science are guiding the agency.

In Panama, Brazil and Malaysia, where the company has already released the GE mosquitoes, people could not avoid breathing in and swallowing mosquitoes due to the vast number of mosquitoes released.

“It is unacceptable that the FDA would approve the widespread release of potentially harmful genetically engineered insects without having the science to back up the decision. Public health could be put at risk, especially considering the likelihood of ingesting the GE mosquitos, and the likelihood of some mosquitoes not being effectively sterilized,” said Jaydee Hanson, senior policy analyst at Center for Food Safety.

“FDA’s assessment and testing was inadequate. How will GE mosquitoes thrive in the wild and what will the inevitable unintended consequences be? These questions have not been responsibly answered,” said Dana Perls, senior food and technology campaigner with Friends of the Earth, U.S. “We should be using the least toxic alternatives that don’t have unintended consequences for our environment and health.”  

Local community members in the Keys have voiced concerns for their own safety. In November there will be two votes for citizens of Key Haven and Monroe County to advise the Florida Keys Mosquito Control Board on whether or not they think the releases should go through. With the FDA’s approval, the decision will ultimately be left to the board.

“People in Florida do not want the GE mosquitos released on their properties. The upcoming votes on Nov. 8 allow people in the Keys to vote on whether they want the mosquitoes to be released, but the Florida Keys Mosquito Control Board does not have to follow the results of the election. This is not what should be happening in a democracy. The U.S. Constitution forbids this kind of ‘taking’ of our land and health by the government,” said Barry Wray, Executive Director of the Florida Keys Environmental Coalition.

“The FDA’s failure to do a thorough review of how these GMO mosquitoes will spread through the environment and possible impacts on local ecosystems is inexcusable,” said Wenonah Hauter, executive director of Food & Water Watch. “The agency seems so eager to speed the process along that they are willing to ignore widespread concern from people who will have to be subject to this experiment.”

The Center for Food Safety is contemplating potential litigation aginst the FDA's approval without full environmental impact analysis, as the organization recommended in its May 13, 2016 comments to the agency. A full environment impact statement should compare all strategies to control the mosquitoes, including using Wolbachia bacteria to sterilize mosquitoes.

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