The release of genetically modified mosquitoes in the Florida Keys cleared a significant hurdle Friday when the U.S. Food and Drug Administration announced they pose no significant environmental danger.
The preliminary findings, to be published in the Federal Register, will be open for public comment for the next 30 days. But the initial federal review likely clears the way for a long-delayed field trial by British producer Oxitec in the tiny affluent neighborhood of Key Haven a mile east of Key West.
Pressure has mounted to speed up testing after the arrival of the Zika virus, which is carried by the Aedes aegypti mosquito, in the U.S. and Florida. While no cases have been contracted locally, health officials fear South Florida could face an outbreak. Oxitec’s genetically modified mosquitoes have already been released in South America, where health officials say an ongoing Zika outbreak could infect 4 million people by the end of the year. The virus is tied to a host of health problems, possibly including a spike in babies born with microcephaly in Brazil.
Oxitec CEO Hadyn Parry welcomed the move.
“The Aedes aegypti mosquito represents a significant threat to human health, and in many countries has been spreading Zika, dengue and chikungunya viruses,” he said in statement. “This mosquito is non-native to the US and difficult to control, with the best available methods only able to reduce the population by up to 50 percent, which is simply not enough.”
Since the company has already outfitted a lab in Marathon for production, the company could move quickly to start tests if local officials back them, he said in an email.
But some residents in the Keys, backed by opponents of the genetic modification industry, have fought bitterly to stop the release, mounting a petition that collected 160,000 signatures.
“People just don’t want to be guinea pigs,” said former nurse and real estate agent Mila De Mier, who started the petition.
Pitched as a safer, more affordable way of battling Oxitec’s modified male mosquitoes are engineered to produce offspring with a kill-switch, or defective gene that kills them. The offspring also bear a florescent marker gene so larvae can be identified when inspectors conduct mosquito counts and gauge the progress of the program.
De Mier, however, say no tests have linked the release of mosquitoes to a reduction in disease and argues that other methods used by the Florida Keys Mosquito Control District to combat Aedes aegypti have been successful. She also likens the tests to clinical trials and believes Oxitec ethically needs to obtain permission from residents.
“You cannot even justify a trial,” she said.
If after the public comment period the FDA approves the test, the district’s board must still approve an agreement with Oxitec, said district spokeswoman Beth Ranson. The issue is not on the board’s Tuesday meeting agenda, although she said it’s likely to come up for discussion, but not a vote.
“So there’s still a couple of steps left,” she said.
The district plans on posting the link for comments on its web site. Comments can be submitted online to the FDA or mailed to The Division of Dockets Management, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
HOW TO COMMENT
The federal Food and Drug Administration is accepting public comments on the draft environmental assessment for releasing genetically modified mosquitoes in the Florida Keys. The public has 30 days to comment from the date of publication in the Federal Register.
To submit comments electronically to the docket, go to www.regulations.gov and type FDA-2014-N-2235 in the search box. While comments are welcome at any time, you should submit them by the closing date to ensure FDA considers them.
To submit your comments by mail, use the following address. Be sure to include docket number FDA-2014-N-2235 on each page of your written comments.
The address: The Division of Dockets Management, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852