Mon, 01/18/2021
I am the executive director of the Nebraska Governance and Technology Center, and in addition to my administrative work for the center, I do my own research primarily in space law – but when it comes to the amazing work our faculty is doing at the intersection of law and technology, I don’t know much besides that I wish I knew more. In this series I’m sitting down with our faculty and fellows for short interviews on their work. In the future, others on our team will also take over as interviewer, but for now I’m here to learn: teach me.
In this post I asked Professor Justin Firestone about synthetic biology and how the law treats this innovative (and slightly terrifying) area.
Thanks for answering my questions Justin! One thing I’ve heard you say is that part of your interest in synthetic biology dates back to watching Willy Wonka and the Chocolate Factory as child?
Absolutely true! When I first read about some of the more futuristic applications of synthetic biology, they included wild ideas such as self-repairing buildings and terraforming Mars for human colonization. For some reason, I immediately imagined a more entertaining application: a new chewing gum that could temporarily (hopefully?) change the color of your skin whatever color the gum was, just like when Violet Beauregarde turns into a blueberry after chewing Wonka's experimental chewing gum. My favorite color is a very bright orange, so I hope the first flavor is tangerine.
What exactly is synthetic biology? How do we, as in society, already use it?
There is still no clear consensus on a definition for synthetic biology, but I describe it first as an engineering discipline, and then I draw a comparison to genetic engineering. Genetic engineering typically involves altering the genome of a species by adding or removing one or two specific genes. The goal is often to improve crop yields or resilience to pests and diseases by inserting or altering a gene which exhibits a beneficial quality. A recent example of this is Arctic® Fuji Apple, which the FDA approved for sale in 2019. The apples have an extra gene which prevents them from producing the enzyme which causes them to turn brown. The genetic alteration makes the apples less likely to bruise or rot, ideally leading to less food waste.
Synthetic biology, on the other hand, could be described as genetic engineering taken to the extreme. Instead of altering only one or two genes here and there, advances in biotechnology have given us the ability to completely rewrite genetic sequences from scratch, creating DNA and RNA strands that have never been seen before in nature. To give you an idea of how vast the possibilities are, a typical plasmid can be 5,000 DNA base pairs of the four different nucleotides. That means there are 4^5,000 different ways to make a plasmid, a number far larger than the estimated number of hydrogen atoms in the universe.
Currently, many synthetic biology applications focus on engineering bacteria to produce chemicals which are otherwise difficult or expensive to manufacture. One early synthetic biology success was engineering bacteria to produce artemisinin, a chemical which is a critical component of anti-malarial treatments. More recently, synthetic biology has been a fundamental reason why COVID-19 vaccine candidates were developed and manufactured so rapidly.
You recently published a paper, The Need for Soft Law to Regulate Synthetic Biology, calling for soft law in regulating synthetic biology. Let’s break that down one piece at a time. Can you tell the readers what soft law is and why you argue it is better positioned than traditional legal methods to address synthetic biology
"Soft law" is used to describe a non-binding legal framework, as opposed to what we traditionally think of as law. Treaties, statutes, and regulations are binding, or what we call "hard" laws. Soft law examples include policy statements, resolutions, codes of conduct, and best practices. Because synthetic biology has such vast potential, it also enables malicious uses which national governments are struggling to regulate. Unfortunately, it is practically impossible to write a statute or regulation that effectively regulates such a rapidly advancing technology like synthetic biology without stifling innovation. It is also unlikely there will be any international agreement on how to regulate synthetic biology because regulation of science and technology often involves ethical considerations.
I worry that a significant accident or intentionally harmful use could spur some governments to enact hard laws restricting or banning research. This highlights another important reason why it is difficult to effectively regulate synthetic biology: it requires far fewer resources and physical space than an activity like enriching uranium or manufacturing chemical weapons. It is also difficult to know for sure what anyone is truthfully doing in a synthetic biology laboratory unless there is significant inspection and oversight.
I am not suggesting we cannot or should not craft hard laws to regulate synthetic biology, but that it is extremely difficult to write a statute or regulation that promotes innovation without loopholes for misconduct. As an alternative, soft law options such as agreed-upon best practices or codes of conduct promote education and discussion about how we should continue applying and improving synthetic biology. Although this means the default rule is self-regulation, we need to start somewhere.
To further complicate matters, synthetic biology is interdisciplinary, and future inventions will blur the lines of traditional regulatory authority granted to federal agencies such as the FDA, USDA, and EPA. Businesses are already confused about which agencies have authority to regulate new synthetic biology applications.
In your paper you advocate for cooperation and collaboration between stakeholders from government, academia, industry, the DIY community, and the public to devise rules for field. Are those efforts already being facilitated anywhere?
Yes! There have been many ongoing discussions and conferences, both nationally and internationally, where a wide variety of stakeholders gather to share their thoughts and concerns about synthetic biology. A good recent example is the work of Todd Kuiken, who has been engaging with do-it-yourself "citizen scientists" to understand and share their views on codes of conduct and responsibility. As an interdisciplinary problem, it will have an interdisciplinary solution.
Are there other fields synthetic biology can look to as a guide for rule-making and ethics?
Many people have drawn parallels with other technologies and disciplines, but the parallels often fall apart when you dig into them. One suggestion is to regulate the equipment and materials needed to conduct synthetic biology, just as we regulate the equipment and materials needed to perform nuclear research. However, it much easier to monitor and detect nuclear equipment and materials than what you need to start your own DIY synthetic biology lab in your garage. Another suggestion is to subject synthetic biologists to a professional licensing scheme, just as we require doctors or lawyers to have licenses to show a theoretical level of skill, competence, and ethical standards. Any attempts at establishing licensing schemes would face strong opposition from both the DIY and professional communities, and it would do nothing to prevent unlicensed activity. Regardless, it is appropriate to look at other regulatory frameworks for guidance, but synthetic biology presents unique challenges.
My focus is in space law. I often hear from people outside the field argue that any regulation is bad regulation and stifles innovation. Do you hear the same criticisms in synthetic biology? Even for light-touch regulatory approaches?
Absolutely. There is real concern that synthetic biology will be reactionarily regulated the same way some nations have regulated genetically engineered foods. There is a lot of pseudo-science and irrational fear about something like an Arctic® Fuji Apple, and many people argue we do not know how genetically engineered crops might pose long-term risks to our health or the environment. If synthetic biology is genetic engineering to the extreme, it is easy to see why some nations would regulate it with a heavy hand. All regulation comes with the risk of stifling local innovation while giving other nations an opportunity to innovate freely.
Finally, I have a question from my 8-year-old: “wait, he could hack my brain?”
Social media platforms are already quite capable of hacking our brains, but yes, there is research into nanoscale molecular communication with neurons and synthetic biology. Some researchers have imagined a not-too-distant future where our bodies are filled with smart nanodevices that can communicate using protocols like those used in traditional computer networks. Hopefully, additional research will provide two-factor authentication for our brains!
Justin Firestone is an Assistant Professor of Practice in the Jeffrey S. Raikes School of Computer Science and Management and in the Department of Computer Science and Engineering at the University of Nebraska-Lincoln. In addition to teaching core Raikes School courses, Firestone also teaches Cyberlaw at the University of Nebraska College of Law and is part of the Nebraska Governance and Technology Center.
Tags: Interviews
