According to the FDA, the release of this GMO male in a Key West suburb as part of a field trial will have "no significant impact" on the health of the local environment or the people who live in it.
"While we didn't expect anything different, we're pleased the FDA has now published their data," said Haydn Parry, CEO of Oxitec, the British company that developed OX513A. "Now we want to get everybody comfortable with the decision."
The use of GMO mosquitoes to fight the Zika virus has gotten recent attention by both the Centers for Disease Control and the World Health Organization as a potential means to combat the growing threat of Zika. Passed primarily by the bite of an infected Aedes aegypti female, Zika is now linked to neurological issues ranging from microcephaly to central nervous system disorders in babies of mothers who contracted the disease while pregnant, as well as fetal deaths and miscarriages. There is also a strong connection between Guillain-Barre, a paralyzing disease, and infection from the virus.
However, it's not Zika that started the process toward America's first GMO mosquito. That happened after outbreaks of dengue fever, also carried by the Aedes aegypti, in Key West in 2009 and 2010. After millions of dollars of effort failed to bring the Aedes under control, local mosquito control officials looked for other options such as OX513A.
The proposed trial will test how well OX513A controls the local population of Aedes aegypti in Key Haven, Florida. Key Haven is a small community of about 475 homes located on Raccoon Key, about a mile east of the island of Key West.
But the thought of a GMO mosquito triggered fear among some members of the local community.
"Less than a mile from the release site is a senior center and a local school," said Mila de Mier, a vocal opponent of the GMO mosquito. "That area was not one that was affected by dengue. Not a single case ever. So why does the FDA want to do an experiment here when they can do this all over the world?"
Today's FDA announcement did nothing to allay her fears.
"People don't want to be guinea pigs," Mier told CNN. "There has been no acceptance from community members. If the local and federal government fail to protect us and our wishes, our last option will be to trust the judicial system and bring it to the court. A legal battle is an option at this point."
"In any public health program it's hard to get 100% support," Parry said in response."I'm sure there will be some that don't agree. But we have a very significant public health threat before us. Time is not on our side if you look at how Zika has been spreading. The sooner we can get going and show what we can do, the sooner we can make a difference in the fight against this virus."
The FDA process began in 2011, and has taken five years to complete. "What's very important in this case is that it's not just the FDA who have evaluated our mosquito," said Parry. "The FDA have used an expert group drawn from Environmental Protection Agency, the Centers for Disease Control, and the Center for Veterinary Medicine, so that everyone involved had a chance for input."
The public has 30 days to file comments with the FDA. After that, the FDA will review comments and issue their final decision. If it remains a go, the first OX513A could be released into the wild soon after.
"Once we have approval, it's a very short time indeed," said Parry. "We already have a mosquito-raising facility in Marathon, Florida, so we would send the eggs from the United Kingdom and begin growing them."
The key factor, said Parry, is when the local mosquito control district would like them to begin. Rainy season, when mosquito populations soar, is April through September in the Keys.