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foreignaffairs | In May 2010, the richest, most powerful man in biotechnology made a new creature. J. Craig Venter and his private-company team started with DNA and constructed a novel genetic sequence of more than one million coded bits of information known as nucleotides. Seven years earlier, Venter had been the first person in history to make a functioning creature from information. Looking at the strings of letters representing the DNA sequence for a virus called phi X174, which infects bacteria, he thought to himself, “I can assemble real DNA based on that computer information.” And so he did, creating a virus based on the phi X174 genomic code. He followed the same recipe later on to generate the DNA for his larger and more sophisticated creature. Venter and his team figured out how to make an artificial bacterial cell, inserted their man-made DNA genome inside, and watched as the organic life form they had synthesized moved, ate, breathed, and replicated itself.

As he was doing this, Venter tried to warn a largely oblivious humanity about what was coming. He cautioned in a 2009 interview, for example, that “we think once we do activate a genome that yes, it probably will impact people’s thinking about life.” Venter defined his new technology as “synthetic genomics,” which would “start in the computer in the digital world from digitized biology and make new DNA constructs for very specific purposes. . . . It can mean that as we learn the rules of life we will be able to develop robotics and computational systems that are self-learning systems.” “It’s the beginning of the new era of very rapid learning,” he continued. “There’s not a single aspect of human life that doesn’t have the potential to be totally transformed by these technologies in the future.”

Today, some call work such as Venter’s novel bacterial creation an example of “4-D printing.” 2-D printing is what we do everyday by hitting “print” on our keyboards, causing a hard copy of an article or the like to spew from our old-fashioned ink-printing devices. Manufacturers, architects, artists, and others are now doing 3-D printing, using computer-generated designs to command devices loaded with plastics, carbon, graphite, and even food materials to construct three-dimensional products. With 4-D printing, manufacturers take the next crucial step: self-assembly or self-replication. What begins as a human idea, hammered out intellectually on a computer, is then sent to a 3-D printer, resulting in a creation capable of making copies of and transforming itself. In solid materials, Skylar Tibbits of the Massachusetts Institute of Technology creates complex physical substances that he calls “programmable materials that build themselves.” Venter and hundreds of synthetic biologists argue that 4-D printing is best accomplished by making life using life’s own building blocks, DNA.

When Venter’s team first created the phi X174 viral genome, Venter commissioned a large analysis of the implications of synthetic genomics for national security and public health. The resulting report warned that two issues were impeding appropriate governance of the new science. The first problem was that work on synthetic biology, or synbio, had become so cheap and easy that its practitioners were no longer classically trained biologists. This meant that there were no shared assumptions regarding the new field’s ethics, professional standards, or safety. The second problem was that existing standards, in some cases regulated by government agencies in the United States and other developed countries, were a generation old, therefore outdated, and also largely unknown to many younger practitioners.

Venter’s team predicted that as the cost of synthetic biology continued to drop, interest in the field would increase, and the ethical and practical concerns it raised would come increasingly to the fore. They were even more prescient than they guessed. Combined with breakthroughs in another area of biology, “gain-of-function” (GOF) research, the synthetic genomics field has spawned a dizzying array of new possibilities, challenges, and national security threats. As the scientific community has started debating “human-directed evolution” and the merits of experiments that give relatively benign germs dangerous capacities for disease, the global bioterrorism and biosecurity establishment remains well behind the curve, mired in antiquated notions about what threats are important and how best to counter them. 

In the United States, Congress and the executive branch have tried to prepare by creating finite lists of known pathogens and toxins and developing measures to surveil, police, and counter them; foreign governments and multilateral institutions, such as the UN and the Biological Weapons Convention, have been even less ambitious. Governance, in short, is focused on the old world of biology, in which scientists observed life from the outside, puzzling over its details and behavior by tinkering with its environment and then watching what happened. But in the new biology world, scientists can now create life themselves and learn about it from the inside. As Venter put it back in 2009, “What we have done so far is going to blow your freakin’ mind.”