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Allison Farrell

Professor Michael Flower


Life Unlimited?
The Regulation Problem of Synthetic Biology
Due to the relative newness of synthetic biology, a lot of people are unclear about what it
really is and the images that immediately come to mind are of human-animal hybrids, twisted
scientific creations, and the act of playing god. But that is not necessarily true. Synthetic
biology is exciting, but not that exciting quite yet, and such advanced feats are well beyond our
means at the moment. Instead, synthetic biology today mainly works on the single-cell level,
combining multiple fields of science for the re-design of existing, natural biological systems
[2] and to make possible the rational design and synthesis of biological systems that serve
human needs [4]. Its not all that different from what humans have already been doing for
thousands of years, altering nature to benefit our own desires, such as the breeding of plants to
create seedless fruits or bigger vegetables. The product is pretty much the same, but the process
is different, allowing precise technology to do more than we could do before, literally designing
new DNA. The process is described as identifying an existing organism with desirable
properties and genetically modifying it to build on or accentuate those properties [4].
But due to the newness of the field, there is still controversy, especially in regards to lawmaking. How should synthetic biology be regulated? The challenge for regulators in relation to
synthetic life science is to devise a legislative and regulatory system that balances security and
safety risks to facilitate research without imposing unreasonable bureaucratic burdens on
scientists and academic freedom [1]. Both sides of the issue are neatly addressed in three
articles, Managing the Unimaginable: regulatory responses to the challenged posed by synthetic

biology and synthetic genomics by Gabrielle N. Samuel, Michael J. Selgelid, and Ian Kerridge,
which is for regulation, and Will Overregulation in Europe Stymie Synthetic Biology? and
Give Genetic Engineering Some Breathing Room: Government regulations are suffocating
applications with great promise both of which are written by Henry Miller and Drew Kershen
and support deregulation. The articles by Miller and Kershen assert that the laws and regulations
of synthetic biology are doing more harm than good, bogging down advancements in
bureaucracy and needlessly taking up too much time, money, and effort. They believe that there
is an unsupported prejudice against synthetic biology as a myriad of testing and red tape hold
back anything that is genetically modified even if the product is the same as other approaches.
They say that the bias puts more scrutiny on biologically engineered products while not really
paying attention to older means of production even if those also have risks that are arguably
more likely due to a lack of precision. They advocate for a free market in regards to synthetic
biology and no or minimal protection of intellectual property [2].
People are worried that there are risks involved with synthetic biology or genetic
modification, but according to Miller and Kershen, Numerous national and international
scientific organizations have repeatedly addressed whether there are unique risks associated with
genetic engineering. Their conclusions have been congruent: There are no unique risks from the
use of molecular techniques of genetic engineering [3]. But this may be too idealistic. While
there may not be an inherent risk with the process and the product, (which also has not had a lot
of time to study long-tern affects), there is more going on in the broad field of synthetic biology
than simply the techniques. There is a large movement to create building blocks for DNA
constructs so that novices can do their own experiments at home.

organizations such as DIYBio.org and BioCurious.org that promote garage scienceamateurs tinkering at home using basic biological tools and supplemented by modular genetic
components ordered from the Internet. This harkens back to the small-scale inventiveness of the
likes of Thomas Edison, Alexander Graham Bell and Thomas Fogarty (who invented a critical
and widely used catheter as a medical student). (Some would say its redolent as well of the
Unabomber, but thats a subject for another day.) [2]
This is a complete disregard for legitimate dangers. There is a big difference between
tinkering with bits of metal or plastic to create catheters or light bulbs versus the manipulation of
DNA and other biological materials. The authors bring up the Unabomber and then immediately
throw him out as a subject for another day. No, this is a subject that directly relates to this
topic. Sure, most people will be doing harmless stuff with their garage science, but there
definitely a real risk that needs to be addressed. There are people out there that given the
opportunity will engineer deadly viruses with terrorist intents. It is not overly-cautious or
paranoid to be concerned about these sorts of things, it is being smart and prepared because it
will happen and it has happened before. For example, after the Unabomber there was the 2001
anthrax attacks. Anthrax spores were mailed in letters to senators and people in the media, killing
5 and infecting 17 people [5]. Not everyone out there is just curious and wanting to research for
the sake of learning, there are people who will take advantage of synthetic biology to hurt other
people. Some people dont even need any reason other than chaos. If synthetic biology is
unregulated, there will be dangers. There needs to be regulation. There needs to be checks and
balances to keep people safe.
A lack of regulation also leads to corruption among the scientists themselves. Of course
the scientists want freedom to research and experiment with whatever they want, but not all

scientists are good and have the right intentions. They are biased and may disregard legitimate
dangers because they think that their research is more important or they just dont realize the
implications of what theyre doing and the ramifications of their actions and how they can affect
the environment or the population in unforeseen ways. There needs to be a balance to keep
everyone in check. Samuel, Selgelid, and Kerridge address this desire for self-governance by
saying,
[critics] argue that the risks of synthetic life science are profound and have an impact on
both society and the environment, and that research and researchers should be tightly regulated.
They believe it would be inappropriate for scientists and engineers, who might benefit from the
investigation and application of synthetic life science, to regulate themselves. [1]
The scientists are too invested in it to be trusted to create the rules of their own conduct.
Who watches the watchmen?
Those for deregulation have a lot to say about the current laws. It is true that existing
regulations for things such as genetic modification are faulty. They are biased and do not
necessarily focus on the right things. But that does not mean that there should be no rules at all.
There needs to be a reform rather than an eradication. There are options other than leaving it to
dopey politicians to make the rules. The Second International Conference on Synthetic Biology
proposed the organization of a working group to promote a range of safety measures.
These include software tools to identify DNA sequences that encode hazardous biological
systems or parts thereof; the control of oligonucleotide synthesis and trade using such sequencechecking technology; promulgation of new specific codes of conduct; and discussions within the
science and engineering research communities and stakeholders [1]

And also saying that:


Given the importance of balancing scientific freedom with biosecurity and
biosafety concerns, they [Miller & Selgelid] argue that neither self-governance nor
centralized governmental control would be appropriateeither an independent authority
or a hybrid of institutional and government regulatory processes would provide the most
ethically robust form of governance, while being able to respond to scientific and
technological progress and achieve the best balance between academic freedom and
public safety. [1]
It seems like the best choice, as it usually is, is a combination of the two sides. The
current form of regulation is unacceptable, but deregulation would be a free-for-all that would
end badly. Im not an expert, but after reading these articles this is what I think we should do.
There should be some sort of high council, or, as the former quotation says, a working group to
promote a range of safety measures. I think this board should be made up of a mixture of
experts in scientific fields related to synthetic biology, environmental experts, law-makers, and a
few morality/ethic experts to create a well-rounded discussion and to uphold a balance as they
keep each other in check. This group can assemble a list of their biggest concerns toward safety
and make a checklist that can be applied to the so-called garage science. The materials being
purchased from these online sources should be monitored, and if a combination or quantity, or
things said on discussion boards, sets off red flags on the list, then they will warrant further
investigation, otherwise leaving most people to do their little experiments. This council of
experts can also use their combined know-how and expertise in their own fields to create a better
groundwork for how the regulatory system should work, by putting into account the different

concerns and perspectives while the check-and-balance system would attempt to hold back
corruption.
The regulation problem will not be a quick issue to solve, but by working together and
rationally approaching the law-making, we can create a better system. Of course it wont be
perfect, and it wont be easy, but its better than allowing the government to create a messy
bureaucracy that gets nothing done, or just eliminating all regulation and letting chaos and
corruption reign.

SOURCES
[1] Managing the unimaginable: regulatory responses to the challenges posed by synthetic
biology and synthetic genomics

Gabrielle N. Samuel, Michael J. Selgelid, and Ian Kerridge


EMBO reports 10(1), 7-11 (2009)
[2] Will Overregulation in Europe Stymie Synthetic Biology?
Henry Miller and Drew Kershen
Forbes.com (August 29, 2012)
[3] Give Genetic Engineering Some Breathing Room
Government regulations are suffocating applications with great promise
Henry I. Miller and Drew L. Kershen
slate.com (February 6, 2015)
[4] The Ethics of Synthetic Biology: Next Steps and Prior Questions
Gregory E. Kaebnick, Michael K. Gusmano, and Thomas H. Murray
[5] The Federal Bureau of Investigation
http://www.fbi.gov/about-us/history/famous-cases/anthrax-amerithrax