Policy Approaches to Synthetic Biology and Do-it-yourself Biology

By Georgia Ray

Synthetic biology, emerging technology, DIYbio, CRISPR-cas9, and other genetic modification tools – whatever you want to call this category, it’s coming in waves and it’s posing big problems to biodefense experts and regulators. An expert panel convened at the 2019 ASM Biothreats conference to discuss what it means.


Jessica Dymond, senior research scientist at Johns Hopkins University Applied Physics Laboratory

Matthew Walsh, associate staff at MIT’s Lincoln Laboratory

Aditya Kunjapur, principle investigator of the Kunjapur Labat the University of Delaware and biocontainment expert

Jessica Tucker, director of theNIH Office of Biosafety, Biosecurity, and Emerging Biotechnology

Mary Delarosa, at HHS ASPR

Peter Carr, senior scientist at MIT’s Synthetic Biology Center (moderating)

Dymond kicked off the panel by discussing distributed technology. These technologies pose special risks – they can be developed or owned by individuals or small groups, and do not come from a small number of controllable sources. We’ve seen national security grapple with this genre in the past: the proliferation of amateur radio, then cyber capacities, then drones. Biology is another step in this progression – it is, arguably, just worse than the others.

Recent red-teaming efforts have suggested that virus acquisition is doable through legal and black market sources. Constraints like tacit knowledge and funding are barriers, but not insurmountable ones.

So how do we govern this? Lessons from cybersecurity suggest the following:

  • Developing norms
  • No one-size-fits-all solution
  • Stakeholder engagement
  • Be willing to consider unusual approaches

Kunjapur discussed biosafety in the lab – he’s an expert on technological approaches to containment and detection of engineered organisms. For many biosecurity concerns, there’s a challenge in getting diverse stakeholders to cooperate – everyone has competing incentives. But companies and biodefense are in agreement over the importance biocontainment of engineered organisms: even absent safety concerns, companies want to protect intellectual property rights by keeping their organisms’ genomes confined to their own labs.

And it seems to be working. Current best practices result in bacterial escape rates below 10-12 –fewer than one in a trillion laboratory organisms. It’s important to note, however, that applied biosafety and risks of organisms escaping from laboratories is wildly under-researched – a great deal of our knowledge about escape rates and safety procedures comes from US biological weapons labs in the 1960s, and has not been updated or revisited since.

Delarosa and Tucker work on biosecurity from a top-down perspective – providing a screening framework for DNA synthesis providers. Their goals are twofold:

1) Limit bad actors’ ability to access harmful organisms.

2) Minimize accidental risks from well-intentioned actors.

The current guidance, from 2010, is to screen all DNA orders for whole or partial pathogenic sequences (depending on length of the ordered strands). DNA synthesis companies are also urged to keep records of their orders.

But 2010 was a long time ago. An upcoming public call for reviews on DNA synthesis guidelines will be held at the Center for Health Security at Johns Hopkins University.

Peter Carr discussed how prevention policies for these kind of new, rare risks are like selling “tiger stones”. (As the joke goes: “I’m selling a stone that repels tigers.” “Does it work?” “Well, do you see any tigers around?”) It’s hard to measure efficacy (or opportunity costs) associated with biosecurity policies or measures in labs. But we still have to move forward on them.

The panel also noted that there are some exciting emerging technologies that may help prevent risks, and that these are worth keeping an eye on as a tool in this fight.

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