International regulation precludes safe biotech development---amplifies likelihood of all negative impacts

Biotechnology Governance in a Time of New Risks and Opportunities The benefits of biotechnology are tangible and obvious to the world. COVID-19 vaccines have saved millions of lives, and CAR-T cell therapies are bringing the concept of personalized medicine to successful cancer treatment. Beyond the medical applications of biotechnologies, it is common to have biological enzymes in laundry detergents for stain removal, plant-based “meats” in burgers that “bleed,” and direct-to-consumer genetic testing ancestry services. These biotechnology advances are not just the result of sustained biological research and hard work by scientists around the world, but also the convergence of advances in computing, machine learning, and the accessibility of powerful research tools that accelerate discovery, allowing important scientific questions to be asked and answered. These sustained advances have influenced consumer expectations, and will lead to more biotechnology products used in everyday life. However, there are also risks to biotechnological progress. Even in the early days of recombinant DNA technologies, it was understood that there were inherent risks in understanding biological mechanisms, as that improved understanding could be used to cause harm. Accidents are also possible if some biotechnology product “escapes” from containment, causing harm to people, animals, or the environment. In response to the potential safety concerns of this new field, a group of scientists, government officials, and journalists met at California’s Asilomar Conference Center in 1975 to discuss the possible risks of manipulating genetic material and to declare a moratorium on the work until safety questions were methodically addressed. Fortunately, there was little cause for the specific safety concerns that spurred the meeting, and biotechnology as a field rapidly progressed. Different conceptions of the risks of biotechnology development, however, did lead to divergent national governance approaches—especially regarding genetically modified organisms (GMOs)—as well as different oversight mechanisms for biological research that involved manipulating genetic material. Those divergent governance mechanisms persist for the regulation of laboratory research and the fielding of GMO crops. More on: Public Health Threats and Pandemics Biotechnology World Health Organization (WHO) COVID-19 Now, with synthetic biology tools like CRISPR, which allows for precise gene editing and gene-synthesis technologies, biotechnology is a more powerful and accessible technology than ever before. Biotechnology is also a truly international endeavor, practiced in laboratories and companies around the globe, complicating the implementation of any governance mechanism that could prevent or mitigate misuse. Nations have evolved their own systems to govern laboratories and biotechnologies, and there is no one place at the international level that harmonizes those different approaches. Still, it remains important to examine how responsible governance could be achieved and to advance the development of workable governance systems to prepare for biotechnology developments in the coming years. While recent advances in science and technology have been amazing—demonstrated in the rapid scientific response to SARS-CoV-2—the apex of biotechnological use and understanding is far off. While it is now possible to “read” and “write” DNA, using that genetic language for “expression,” particularly of new functions important for engineering biology, remains a work in progress. Understanding the language of DNA still requires considerable research and development, trial and error, and basic research. A great deal is not yet understood about the natural world, such as infectious diseases that afflict animals, plants, and humans and the responses to those pathogens by the human immune system. The function of many genes is still difficult to know just by looking at the genetic sequence. In 2016, J. Craig Venter and colleagues published a “minimal bacterial genome,” which was a pared-down version of Mycoplasma genitalium, containing only those genes essential for life. To date, the functions of many of these “essential genes” are unknown. When the omicron variant first started causing a rapid rise in COVID-19 cases in the winter of 2020–21, researchers observed that the omicron variant was significantly different from the delta variant in its sequence. Yet how those differences translated into actual differences in transmissibility or clinical impact was impossible to determine until cases of illness could be observed; they could not be reliably predicted. The fact that there is much to learn about biology should be a source of optimism and a call to action. The foundations for governance built now could have lasting and beneficial influences on the future trajectory of biotechnology so that its advantages are realized while minimizing risks