LAWRENCE — When the first widespread computer virus was born, government didn’t shut down all computer science research. Similarly, now that synthetic biology, a field of science that uses standardized pieces of DNA to build new life forms, medications, industrial processes and biological systems, is growing rapidly, it should not be overregulated at the cost of future innovations, a University of Kansas law professor says.
Andrew Torrance, professor of law and Docking Faculty Scholar, has co-authored a new study on synthetic biology, intellectual property and the standards that govern the field with Linda Kahl of the BioBricks Foundation, the leading synthetic biology institution. It has been published in the Santa Clara High Technology Law Journal, and it is based on a 2012 study Torrance was commissioned by the National Academies to prepare.
Synthetic biology is being used to design new medications to fight malaria, is developing radically new technologies such as a television in which yeast cells genetically engineered to bioluminesce act as the television’s pixels, produce biological computers and create living organisms from raw organic chemicals. Yet there is also concern that this “dual use” technology could be used with malicious intent to design new forms of disease pathogens or that there could be accidents.
“From its founding the synthetic biology community has been concerned about ensuring safety, health and ethical practices,” said Torrance, who holds a doctorate in biology from Harvard. “The community has explicitly committed itself to uses of the technology that benefit humanity and avoidance of uses that could endanger public safety, especially those with nefarious purposes.”
In the study, Torrance and Kahl examine all of the proposed standards that have been proposed to regulate synthetic biology, including standards regarding structure, function and description of genetic components, data sharing, biosecurity and law. In fact, several years ago the BioBricks Foundation asked Torrance to contribute to the early drafting of a sort of “legal constitution” for synthetic biology, called the BioBricks Public Agreement, intended to ensure the safe and beneficial invention and use of standard biological parts.
Torrance and Kahl also consider the effects that intellectual property rights may have on encouraging or discouraging research in the burgeoning field. Like other areas of biotechnology, there is no federal statute specifically designed to govern synthetic biology. Instead, an influential regulation called the Coordinated Framework assigns agencies such as the FDA, EPA and USDA with shared responsibility for ensuring safe practices. One unique factor of synthetic biology is the degree to which its research community has engaged in careful self-regulation to keep the field open, democratic and safe, Torrance said. As the science progresses and the methods and raw materials of synthetic biology become ever more available, practicable and attractive to citizen biologists in the general public, Torrance expects that trend continuing.
“I see synthetic biology becoming further democratized — something that almost anyone with a modest biological background can become involved in,” Torrance said. “Just as software programming became a common and widespread skill in which millions of people now participate, programming DNA, designing new biological machines and constructing novel organisms is rapidly leaving the confines of professional laboratories and entering the home laboratories of citizen biotinkerers.”
However, as more people get involved in a field that builds new organisms and puts together building blocks of DNA, there is understandably a concern for accidents or misuse. The field has been very open in its dealings, even regularly working cooperatively with FBI agents specifically assigned to monitor the field. The field uses an open science ethos, arguing that its knowledge should be available to all, and that the more people who take part, the broader the knowledge base that can be built, and more potential there is both for beneficial discoveries and for detecting and preventing malicious uses.
There is also debate as to whether the field is a threat to traditional drug development companies and whether the ability to patent DNA can effectively prevent people outside of large corporations and major university research labs to take part. There are yet to be good answers to those questions, such as whether a fear of being sued will stifle innovation by individuals in the field, as the science is still only about a decade old. Torrance suggests that answers will come as evidence accumulates and legal conflicts multiply.
While there has yet to be an overwhelming push by policymakers or the public to write new laws or create new standards governing the field, the potential for accidents such as Three Mile Island and Chernobyl may exist.
“It is too early to know precisely what roles law will play in the development of synthetic biology and its innovations,” Torrance said. “However, since law will certainly influence the evolution of synthetic biology, it is vital to think carefully and strategically about constructive roles law should play in ensuring beneficial innovation, biosafety and sound ethical practices.
“As the field of synthetic biology explodes there will be an increasing number of success stories, but along with these, there will almost certainly be accidents, ethical breaches and malicious misuses. It is vitally important to create a legal framework that fosters the benefits of this technology while vigilantly guarding against bad behavior. It is exceedingly difficult to develop any new technology if you’re not willing to take some risks. The only way to eliminate risk entirely is to eliminate innovation. Wise laws can help assure that the great promise of synthetic biology is achieved at minimal risk.”