Change in Regulation is Necessary for Genetically Engineered Mosquitoes

Millions of genetically engineered (GE) mosquitoes could soon be released in Key West, Florida as an effort to eradicate wild mosquitoes that are transmitters of diseases such as malaria, dengue, and chikungunya. Both international and domestic regulations fail to provide effective regulatory schemes that can facilitate the application of this technology while ensuring all safety and environmental aspects are properly addressed. The Food and Drug Administration’s assertion of jurisdiction is based on its assessment that the GE mosquitoes are “animal drugs” under the Federal Food, Drug, and Cosmetic Act. This is especially troublesome because the end goal of using these mosquitoes is to prevent diseases in humans, which are not “animals” under the statute. Also, the current scheme only regulates the engineered gene inside the mosquito, but not the mosquito itself, and fails to account for the fact that the mosquito is a living animal that acts separately and independently from the engineered gene inside. Moreover, the U.S. Department of Agriculture’s voluntary abrogation of jurisdiction is questionable because it had asserted jurisdiction on other GE insects and accumulated extensive experience in dealing with such issues. Instead, Mexico’s approach of establishing a separate federal-level regulatory body specifically for genetically modified organisms could be instructive. No matter what the solution, some change in regulation addressing GE mosquitoes has become even more urgent with the recent spread of Zika virus in the U.S.