The U.S. Food and Drug Administration is seeking the public’s opinion on the regulation of mosquito-related products going forward.
A 30-day comment period began Jan. 19 asking about which mosquito products the FDA regulates and which ones the Environmental Protection Agency regulates.
The document open for public comment is titled “Draft Guidance for Industry 236.” According to the FDA, the document “describes the FDA’s understanding that mosquito-related products intended to function as pesticides by preventing, destroying, repelling or mitigating mosquitoes for population control purposes are not drugs” under federal law.
When the guidance is finalized, it continues, those products would “be regulated by EPA.... Under the draft guidance, FDA would continue to have jurisdiction over mosquito-related products ... such as those intended to prevent, treat or cure a disease.”
If the “guidance” is adopted, genetically modified bugs like those produced by British biotech company Oxitec apparently would be regulated by the EPA, not the FDA as is the case now.
“They’re suggesting that the lead agency should be the EPA moving forward,” said Derric Nimmo, product development manager at Oxitec.
Oxitec says the offspring of its GM mosquitoes die almost immediately, resulting in a smaller population of Aedes aegypti, which carry Zika and other viruses.
Nimmo said Oxitec’s mosquitoes are intended to control the mosquito population, not specifically prevent disease. Oxitec’s proposed trial GM bug release with the Florida Keys Mosquito Control District has been regulated by the Centers for Disease Control, the EPA and the FDA Center for Veterinary Medicine, he said.
“We’d be dealing with just one agency in the future and it’d technically be a smoother process,” Nimmo said. “We support it.”
The three agencies in August 2016 together released an environmental assessment about Oxitec releasing mosquitoes in the Florida Keys that said there would be no significant impact on people, animals or the environment.
“The issue comes down to the fact that the FDA was doing something kind of on the skirt of what it has experience doing,” said Lower Keys physician John Norris about the assessment and the change in regulation.
Norris has been vocal about wanting the GM bugs to be swabbed for antibiotic resistant germs before they’re released. The mosquitoes are genetically engineered to need the antibiotic tetracycline to survive, he said. Since bacteria develop resistance to antibiotics after exposure to too much or too little, the surviving bacteria could become even more powerful and resistant to medicine down the road.
Wolbachia-infected mosquitoes like those created by biotech company MosquitoMate Inc., working through the University of Kentucky, are regulated by the EPA.
Aedes aegypti mosquitoes are not naturally infected with the Wolbachia bacteria. So if a female Aedes aegypti mates with a male that has Wolbachia, her eggs will not hatch, according to Dr. Stephen Dobson, founder and CEO of MosquitoMate. MosquitoMate was approved to try to reduce the population of Aedes aegypti mosquitoes in the Florida Keys with a trial in March.
To electronically submit comments about the draft guidance, visit www.regulations.gov.
Katie Atkins: 305-440-3219