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Advocates Challenge FDA on First Ever GE Mosquito Release
November 22nd, 2016

Photo - Endangered Lower Keys Marsh Rabbit

Chad Anderson/USFWS

Government fails to assess risks to dozens of endangered species from novel experiment releasing millions of GE mosquitoes

WASHINGTON— A coalition of public interest groups filed a formal pre-litigation notice with the Food and Drug Administration (FDA) that they intend to sue the agency for its approval to release millions of genetically engineered (GE) mosquitoes into the environment. The groups, including Center for Food Safety (CFS), Friends of the Earth (FOE), Foundation Earth, the International Center for Technology Assessment (ICTA), the Florida Keys Environmental Coalition, and Food and Water Watch, have issued a 60-day notice of intent to sue FDA for failing to take into account impacts on endangered species in a fast-tracked approval of a release of GE mosquitoes in the Florida Keys. Center for Food Safety’s legal team will represent the groups and local residents who have voiced concern as they defend forty-three protected species. The release of the GE mosquitoes would be the first ever in the United States, but FDA has failed to conduct adequate testing for impacts.

“FDA cannot just arbitrarily approve releasing an entirely novel genetically engineered organism into the environment without accounting for risks. The Florida Keys are home to some of the most diverse and threatened species in our country, and we will not stand by and allow the government to break the law by approving this unprecedented experiment without analyzing its impacts,” said George Kimbrell, Senior Attorney for the Center for Food Safety.

Threats to endangered and protected species are detailed in numerous comments to FDA, including comments from the U.S. Fish and Wildlife Service (FWS) requesting more data. Under the Endangered Species Act (ESA), FDA is required to consult FWS on these potential impacts to protected species. But in its haste to approve the mosquitoes under pressure from manufacturers Oxitec, the groups argue in their notice of intent, among other things, [CS1] that “FDA’s ‘No Effect’ Determinations Are Arbitrary and Did Not Use the Best Scientific and Commercial Data Available.”

If FDA does not cure these violations within sixty days, the listed organizations intend to file suit against the responsible agencies and officials to enforce the ESA.

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Background

On November 9th, residents of Key Haven, Florida, the proposed release site of the GE mosquitoes, voted against the release of the insects, which were not adequately assessed for risk before being approved by the FDA.

The lack of independent scientific research on the release of GE mosquitoes constitutes a most troubling factor in the drive to release millions of these insects. While the desire to control viral diseases like zika and dengue is understandable, Oxitec, the company manufacturing the GE mosquitoes, has not demonstrated that its release of the mosquitoes in Brazil, Cayman Islands and Malaysia has reduced disease.

In addition to potential threats to endangered and protected species and sensitive ecosystems, and a lack of evidence to support the GE mosquitoes’ efficacy at minimizing the spread of disease, there is little information about what ingesting these insects could do to people. In Brazil, so many mosquitoes were released in the Oxitec trials (millions are released multiple times a week) that people complained of being forced to breathe in and eat mosquitoes.

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