Humans have been able to genetically alter the world around them for thousands of years. With the domestication of dogs at least 14,000 years ago, genetically modified organisms (GMOs) have been a constant feature of human society; only recently have we gained the ability to perform these modifications at the molecular level.
Even more recently, gene drive technology has fundamentally added the ability of humans to modify wild organisms, not only domesticated organisms. With the ability to make rapid, permanent changes to wild species on the near horizon, we must act now to implement policies that will carefully regulate their use while allowing for vital scientific research to continue.
While GMOs have become fundamental to the farming industry, they always have the same limitation: they must be protected and maintained on farms, in pens, or other human-maintained environments. If released into the wild, GMOs find themselves out-competed by their naturally occurring cousins, since genetic modifications made to suit human tastes (think seedless watermelons) typically have a hard time surviving in the wild. An exception to this rule is the survival of invasive species when introduced into a different environment and have no natural competition in their new habitat.
Gene drive technology now makes it possible for humans to engineer species that are currently and will remain, wild — such as the mosquito. Gene drive engineering can create an artificial selective pressure to transmit the gene drive from parent to offspring at a higher rate than would naturally occur.
Eventually, offspring with the gene drive replace the unaltered form of the organism, an overwhelming natural section that would normally favor the unaltered form. This profoundly new capability makes gene drives different from GMOs which are not designed to replace wild organisms and do not have the capability to overtake wild populations if accidentally released.
Because gene drives, as tools for the management and engineering of species in the wild, are intrinsically different from GMOs, it is not adequate to regulate them like other GMOs or rely only upon the framework of existing GMO regulations. We need a series of policy goals to prevent missteps in the deployment of this powerful tool.
It is unlikely that gene drives will see direct use in agricultural crops and animals, despite the agricultural application being the main concern of gene drive opposers. Such cultivated species are already under de facto genetic control by farmers who decide which animals to breed and which seeds are sown. As such, a gene drive in farmed species would be a very expensive and complex way to achieve something already possible through conventional agricultural methods.
It is, however, quite likely that gene drives will soon be used to control malaria, either to suppress malaria-carrying mosquito populations or genetically alter them such that they are unable to transmit malaria to humans. Should this public health application prove to be safe and beneficial, further applications of gene drives may soon follow. Another near-term application could be to control agricultural pest species such as leafhoppers or aphids in order to improve crop yield.
The management of “human-influenced” species with gene drives presents a potential flashpoint where conflicting economic and environmental interests intersect. We define “human-influenced” species as those that live and breed wild but are harvested heavily by humans. In other words, humans do not actively alter the environment of these species for agricultural purposes, but human harvesting activities have direct and indirect impacts on their population dynamics. Oceanic fish are an example of “human-influenced” species. These fish may live and travel across international and national territorial waters, and thus the release of a gene drive in these species would result in significant and competing economic interests. The ability of genes to drive fish to move from jurisdiction to jurisdiction presents a unique problem to international biodiversity protocols.
With the first release of gene drives for malaria control is likely to occur within the next 5-10 years, there is a need for immediate national regulation of gene drives and a need for broad international harmonization of gene drive regulation. While great care has been taken by researchers to safely and ethically advance malaria control gene drive research, explicit regulation is required to mitigate risks from future efforts and to hold all deployable gene drives to appropriate standards.
As we have experienced during COVID-19 with poorly functioning antibody tests, a loose regulatory environment can lead to products entering the market that have not been properly validated. In the case of gene drives, a loose regulatory environment could lead to irreversible damage to wild ecosystems.
The U.S. government should create nationally-mandated tiered registries of gene drive research. Coordinated, nationally-mandated registries would allow for the fast adoption of clear gene drive documentation. In time, the multiple national registries can hopefully be harmonized into a single international registry. These registries should be tiered in such a way that gene drives that are closer to possible deployment must report more detailed information than research projects that are in the exploratory phase.
As projects approach deployment, public transparency and independent review become more important considering the potential for gene drives to radically alter a wild environment. To realize the potential benefits of this technology, we now must act practically, proactively, and carefully to regulate their progress from small-scale research all the way through large-scale deployment.
Michael Montague, Ph.D. is a senior scholar and Amanda Kobokovich, MPH is a senior analyst at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health. The authors recently published a report “Gene Drives: Pursuing Opportunities, Minimizing Risk.”