U.K.-based biotechnology company Oxitec has partnered with the Florida Keys Mosquito Control District in an effort to control the invasive and disease-spreading female Aedes aegypti mosquitoes in the region.
Oxitec's male mosquitoes -- which don't bite, unlike the recently-discovered yellow fever-carrying Aedes scapularis mosquitoes -- will be introduced in small areas in a select number of neighborhoods between mile markers 10 and 93 in the Keys.
The project, Oxitec hopes, will be successful in passing what Oxitec Head of Regulator Affairs Dr. Nathan Rose calls a "self-limiting" gene from its genetically modified males to their wild mates, ensuring future offspring do not mature into adulthood and reducing the population.
Rose told Fox News on Friday that this project will be critical as the U.S. sees mosquito-borne disease "actually becoming a problem" more and more, citing locally transmitted Dengue Fever outbreaks in the Keys and the Zika virus crisis in Summer 2016 that the U.S. Centers for Disease Control and Prevention (CDC) said infected 29 persons within a 6-block area forcing them to aerial spray to control mosquitoes.
While more than 7,300 Dengue cases were reported in the U.S. between 2010 and 2020 -- cases are largely contracted outside the U.S. -- there were 71 cases that were transmitted locally in the Sunshine State, according to the CDC.
"So, mosquito-borne disease is a thing in the U.S., and it's likely to get worse in the future as a result of climate change [and] as these mosquitoes kind of move farther and farther north from the Gulf Coast into more and more of the continental U.S.," Rose told Fox News. "So, the diseases are a big problem because these particular diseases don't have any effective vaccines or medications to treat them [and] the only way to control them is actually to control the mosquitoes that spread them..."
Although the final agreement and approval were announced just last year, this is not Oxitec's first rodeo.
The company claims a trial of Oxitec’s Aedes aegypti technology in Brazil and a 2016 test in the Cayman Islands were successful and did not "persist in the environment or cause harm to beneficial insects," according to its website.
"Recent similar demonstration projects in the Brazilian city of Indaiatuba found that Oxitec’s mosquito suppressed disease-carrying Aedes aegypti by up to 95% in urban, Dengue-prone environments following just 13 weeks of treatment, as compared to untreated control sites in the same city," it wrote.
Rose said their aim in the U.S. is to demonstrate that their male mosquitoes perform just as well on American soil as they have "been shown to do in other countries" just on a "small scale."
"And then, once we've done that -- once we have the data from that -- then we have to go to the U.S. regulatory agencies to actually get a commercial registration to be able to release these mosquitoes more broadly within the United States," he explained.
Rose said while the company plans to commence with its endeavor -- using what they call "just-add-water technology" -- "pretty soon" using a "phased rollout," it is currently monitoring the mosquito population in the area.
"So, what we do first: the first phase of the project is really just releasing mosquitoes from a few single locations. And, what we want to look at there is how far are they flying and how long are they living in the environment in the Keys?" he asked. "And then, once we have the information from that, then we'll move on to small neighborhood releases where we will release the mosquitoes over a neighborhood of maybe say 15 acres or something like that. And then, what we're looking at is the impact of those mosquitoes in actually making effectively report the wild mosquitoes throughout that neighborhood."
Regulatory approvals for the first phase have already been provided by the U.S. Environmental Protection Agency, Centers for Disease Control and Prevention and multiple Florida state agencies, including the Department of Health and Department of Agriculture and Consumer Services.
In August 2020, the Keys mosquito control district's board of commissioners approved the agreement for the 2021 release. Oxitec says an independent evaluation of the project will be provided by the CDC, University of Florida’s Medical Entomology Laboratory, Monroe County Department of Health, and local leaders.
The EPA, which completed a risk assessment and opened the discussion up to the public, approved an experimental use permit and determined after its review of pertinent information surrounding the manufacturing, production, quality assurance processes and standard operating procedures that the agency could "support a finding of no unreasonable adverse effects to man and the environment during the proposed EUP."
"So, the EPA looked at this really, really carefully. It took more than a year to review a lot of data that was submitted. And, they looked at the safety of the mosquito both to humans and the environment. And, the conclusion was that there was no risk to humans or to the environment as a result of releasing these mosquitoes," Rose said, assuring that there "is no risk to anyone in the community."
He said he believes the "real risk" is a mosquito-borne disease in addition to the devastating impact of the COVID-19 pandemic.
However, while viruses continue to spread, so does Floridians' skepticism.
Notably, The Associated Press reported that the Cayman Islands project had been delayed by opponents to the project who "argued that the government had not provided sufficient information about potential risks or adequately studied other alternatives."
In recent reporting from Undark, the non-profit digital science magazine notes that Oxitec had been proposing an experimental release in the Keys for years and that it had been rejected before in both Key Haven and Key West -- though some residents in surrounding areas voted in support of the release.
According to Undark, critics want more proof that the release is necessary, further information about the process and disease monitoring and more public engagement.
Another worry presented in their piece regards the antibiotic tetracycline -- without which the female mosquitoes will die in early larval stages and is used commonly to treat bacteria in sewage plants and in agriculture -- and the EPA's risk assessment.
While the assessment notes that the releases will not take place within "500 m of commercial citrus growing areas or wastewater treatment sites due to considerations regarding the impact of environmental sources of tetracyclines on female OX5034 mosquito survival," North Carolina State University's Genetic Engineering and Society Center told Undark that the assessment did not include testing of standing water for tetracycline.
Rose told Fox News that the EPA looked at concerns about tetracycline "very carefully" and had "assessed whether there is any potential to actually have tetracycline in the water in the environments in the areas where these mosquitoes will be released."
"And, the conclusion was that there was no risk of that and they restricted the releases to areas that were not going to have tetracycline presence in the wild. So, I don't see that as a concern," he said. "That is something [that] was looked at really carefully by the EPA."
But the questions don't stop there. Residents and environmentalists have wondered about any unintended effects of the project, noting that a controversial Yale University study that analyzed Oxitec's Brazil release had claimed some of the offspring of the genetically modified mosquitoes had survived to adulthood.
Oxitec vehemently denied the findings, telling Gizmodo in 2019 that the study includes "numerous false, speculative, and unsubstantiated claims and statements."
"You have no idea what that will do," Barry Wray, director of the Florida Keys Environmental Coalition, told the FKMCD at a meeting last summer.
The digital magazine says Wray and others argue the community wasn't given a chance to consent before the EPA approval, while the EPA says it reviewed thousands of public comments and Oxitec touts a 2016 non-binding referendum they state shows "Monroe County residents are overwhelmingly supportive of Oxitec’s technology."
The EPA has given its approval for the pilot projects in Florida through spring 2022 and Oxitec has pledged to continue public engagement efforts, like the webinars posted to the Oxitec project site.
Keys mosquito district Chairman Phil Goodman told Undark that many do not understand Oxitec's technology and are "fearmongering."
District Spokesperson Chad Huff wrote in an email to Fox News on Friday that, given the success of the technique in other countries, the pilot project is "expected to work without consequence" but "to what degree, remains to be seen."
"And so, if we can actually bring this as another tool to help mosquito control authorities get on top of these mosquitoes, that's really important for us," he said.
In the 2020 announcement of landmark approval for the pilot project, Oxitec CEO Grey Frandsen said, "We’re looking forward to working hand-in-hand with the Keys community to demonstrate the effectiveness of our safe, sustainable technology in light of the growing challenges controlling this disease-spreading mosquito."