Legal action threatened against FDA over Oxitec decision

A coalition of environmental groups is threatening to sue the federal government over the U.S. Food and Drug Administration greenlighting a British company’s plan to release millions of genetically-engineered mosquitoes in Monroe County.

The six organizations — some based locally, some internationally — argue the FDA did not take into account the impact the experiment could have on endangered species living in the Florida Keys. Their lawyers filed formal pre-litigation with the FDA informing the agency a lawsuit is coming if the approval is not reconsidered.

“FDA cannot just arbitrarily approve releasing an entirely novel genetically engineered organism into the environment without accounting for risks,” George Kimbrell, senior attorney for the Center for Food Safety, said in a statement. “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.”

The FDA in August approved UK biotech firm Oxitec’s plan to release the lab-bred mosquitoes. The mosquitoes, almost all male, are genetically engineered to sire offspring that can’t survive. The goal is for them to mate with local female Aedes aegypti mosquitoes and eventually wipe out the species, which carries illnesses like Zika, dengue fever and chikungunya. The FDA said the experiment would have no significant environmental impact.

But Kimbrell said the FDA did not use the best scientific and commercial data available before making that determination. The agency also did not consult with the U.S. Fish and Wildlife Service to discuss the possible effect Oxitec’s trial may have on endangered species in the Keys.

“Threats to endangered and protected species are detailed in numerous comments to FDA, including comments from the U.S. Fish and Wildlife Service requesting more data. Under the Endangered Species, FDA is required to consult FWS on these potential impacts to protected species,” Kimbrell said in the statement.

The groups — also including Friends of the Earth, Foundation Earth, International Center for Technology Assessment, Florida Keys Environmental Coalition and Food and Water Watch — are giving the FDA 60 days to re-study the issue or a lawsuit is imminent, Kimbrell said.

“If FDA does not cure these violations within 60 days, the listed organizations intend to file suit against the responsible agencies and officials to enforce the Endangered Species Act,” he said.

JuliAnn Putnam, an FDA spokeswoman, said “the FDA does not comment on possible, pending or ongoing litigation.”

Oxitec’s proposal met with local opposition, particularly from people living in the small Lower Keys community of Key Haven, where the company and the Florida Keys Mosquito Control District planned to release the bugs. Two referenda were on November’s ballot regarding the proposal. One asked Key Haven residents if they were in favor of the release. The other asked the same question to voters in the rest of the county. While the countywide vote was affirmative, Key Haven voters rejected the nonbinding ballot initiative.

Each of the five elected members Mosquito Control District board said their decision whether or not to approve the Oxitec proposal would hinge on the results of the referenda. At a meeting last Saturday, the board voted 3-2 in favor of the district’s contract with Oxitec. However, Key Haven is not the venue for the trial anymore.

The district will find a new area by trapping mosquitoes at various locations Keyswide to find Aedes aegypti species populations large enough to justify the trial, Beth Ranson, spokeswoman for the Mosquito Control District, said at the Saturday meeting. The FDA must then approve that site. (See related story on page ...)