GE mosquito release remains on indefinite hold — but for how long?

Last weekend the Keynoter newspaper in the Florida Keys reported that plans to release genetically engineered mosquitoes in Key West “remain on indefinite hold.” This came after an announcement by the Florida Keys Mosquito Control District that this controversial experiment “will only take place once all necessary regulatory and ethical approvals have been obtained, from regulatory agencies at both federal and state level, based on the results of independent, rigorous, scientific review.”

FKMCD and its director, Michael Doyle, should be applauded for not rushing ahead with this experiment before receiving federal and state approval, or before these genetically engineered mosquitoes and their possible risks are independently and properly assessed.

The debate over which federal and state agencies would oversee the release of genetically engineered mosquitoes in the U.S. has been filled with confusion but is starting to become a bit clearer. Ever since the USDA stated back in November 2011 that it will not regulate the release of genetically engineered mosquitoes in the Florida Keys, as originally expected, FKMCD and Oxitec (the creators of the GE mosquito) have been scrambling to find a federal agency that will take the lead. It appeared the federal agencies were playing a game of regulatory “hot potato,” each one passing on taking the leading role.

But just last week, Oxitec stated in a Bloomberg article that it has “opened an investigational new animal drug file with the Food and Drug Administration.” While this might sound wonky and bureaucratic, it is actually a telling move on the part of Oxitec — one that starts to clarify if – and how – these genetically engineered mosquitoes will be regulated in the U.S.

In January 2009 the FDA came out with Guidance 187 which stated that the agency would regulate genetically engineered animals as “new animal drugs.” This idea originated in the Reagan administration and its’ Coordinated Framework for the Regulation of Biotechnology, which stated that the U.S. didn’t need any new laws to regulate biotechnologies or their products –instead old laws could be interpreted in order to accommodate new technologies.

And so the FDA decided to use laws originally written to approve new animal drugs (think: vaccines for cattle, antibiotics added to chicken feed) to regulate the use of genetically engineered animals, and now insects. The FDA’s twisted logic reads like this: drugs change the composition and function of an animal; the genes inserted into an animal also change their composition and function; so ipso facto GE animals are new animal drugs. If this sounds like something out of a Kurt Vonnegut novel to you, you are not alone.

We have been fighting this wacky interpretation of how GE animals should be regulated for years. The FDA is also trying to approve a genetically engineered salmon, which would be the first-ever GE food animal, as a “new animal drug” as well. Yes, a fish we are supposed to eat is being approved as a new animal drug. And this classification makes even less sense for GE mosquitoes.

There are two overarching problems with using new animal drug laws to approve genetically engineered mosquitoes. First, classifying a genetically engineered mosquito as a ‘drug’ is the regulatory equivalent of trying to fit a square peg into a round hole. These GE mosquitoes aren’t the same thing as, say, a new animal feed additive; an additive can’t reproduce in the wild, bite humans and spread disease,  or fly to another part of town. Therefore the questions regulators would need to ask regarding risks are entirely different.  So while the FDA might be able to determine the risks of an animal feed additive, that doesn’t mean it can do the same for GE mosquitoes. The FDA does not have the necessary expertise to judge the mosquitoes’ environmental effects and has a poor track record of collaborating with other agencies that could provide scientific and technical analysis. This is not the fault of the FDA, necessarily, since we can’t expect veterinary medicine experts to understand insect ecology. But it does mean our regulatory system has failed to keep up with new technologies and the current system is broken.

The second broad problem is the lack of transparency around new animal drug applications. As we have unfortunately learned through the FDA’s process for approving the GE salmon under these same laws, the public has little knowledge or input into the agency’s decisions; the FDA had the GE salmon application for over 10 years before it even announced the existence of the application and when it did, it was only because the application  was close to final approval. The public only received information that the GE salmon company and the FDA deemed was not “confidential business information.”

With the current process, the FDA could approve these GE mosquitoes for release as an “investigational new animal drug” and the public would not know, nor would it have any data, until the decision has already been made. “Independent, rigorous, scientific review” cannot happen in secret, behind closed doors. That would be bad science, bad policy, and would set a bad precedent for how GE insects are regulated.

The indefinite delay of genetically engineered mosquitoes in the Florida Keys is a victory for the grassroots organizations in the Keys, but unfortunately it may only be temporary. Now that we know Oxitec has a file open with the FDA to approve its mosquitoes as an investigational new animal drug, approval could come at any time and the public would have no warning or input.

Using antiquated laws that are ill-equipped to deal with novel risks posed by GE insects would set a dangerous precedent here in the U.S. and abroad and should not be allowed to continue. The time has come to actually write laws that address the novel risks posed by genetically engineered animals and insects, and to develop proper risk assessment models to measure the dangers.

The only way to stop this experiment outright is for the Florida Keys Mosquito Control District to announce it has cancelled its plans to release genetically engineered mosquitoes or for the FDA to stand up for the Keys residents and reject this application. If not, don’t expect this issue to disappear any time soon.