Sue Chun

Life Unlimited / Winter2015

Second Essay

My View on Regulation Problem

Just like other kinds of newly developed technology, it is certain that
synthetic biology can bring enormous benefits as well as positive changes in
the population which gives us the rights to intervene in such changes that
start from the successful technologies. As the interests in synthetic biology
rises, there are many voices that point out the importance of opening the
room for discussion about the ethical and social aspects of its future impacts.
Like the project called SYNBIOSAFE from the EU that is designed to study
synthetic biologys safety and ethical aspects and to raise the arguments of
them to consider countermeasures, there are various government and
private institutions that review these aspects. So how do we make sure what
we get from them is safe and socially acceptable? Or is there even a rule
to define whether they are or not?
The most controversial issue with setting the regulations on synthetic
biology is where to draw a moderate line between where to intervene and
where to let the scientists be. Samuel, Selgelid, and Kerridges 2009 article
called Managing the unimaginablegenomics states that the regulators
should devise a regulatory system that does not impose unreasonable

bureaucratic burdens on scientists and academic freedom. It is also stated

that scientists who benefit from the investigation and application of synthetic
life science regulating themselves can be read as inappropriate. In opposition
to this article, Miller and Kershen in their article called Givegreat promise
(2015) gives another argument about burdensome unnecessarily intrusive
regulation leading to formidable regulatory delays and expense claiming that
the properties of a genetically modified organism should be the focus of risk
assessments, not process by which it was produced. (pg. 5) I understand
where both arguments are coming from and agree with each of them which
is why I would like to stand on the side of supporting hybrid of independent
authority and government regulatory processes as a tool to balancing
scientific freedom with biosecurity and biosafety concerns.
Biosecurity has a goal of upgrading the quality of human welfare through
the scientific investigation. But not all of the inventories that were made with
good intentions are used in positive ways. When the technologies of
rebuilding the natural objects or even creating what is not in the nature is
abused, the destructive power of it can be very strong. Another guaranteed
outcome of such investigation like synthetic biology is financial. When given
this fact, there is a high chance of scientists clinging to the studies that could
simply make more money which raises the problem of possible physical harm
on humans being excluded from the consideration. Although this kind of
problem can be found in the other biology investigations, there is a reason

why synthetic biology needs more awareness. The skills used in synthetic
biology are easy to apply in a way that they can synthesize the organisms
with low costs. As an example, one of the most important achievements
synthetic biology made is composing a dielectric substance of poliomyelitis
virus with oligonucleotide. This virus is very fatal, but oligonucleotide is
something we can order by mail in the United States. And with this, we can
make a logical connection of dual use dilemma about synthetic biology
which can be read as ethical problem. As mentioned, it is certain that
synthetic biology will bring us tremendous financial benefits and such fact
could make the scientists not want the regulations getting in the way to
delay or stop the their inquiry. Another thing to be aware according to J.B.
Tucker and R. a. Zilinskas is lone operator and biohacker scenario.1 The lone
operators using synthetic biology as a tool to harm those who they have
hatred for, and biohackers simply spreading synthesized organisms just to
display their abilities can both result in serious harm on humans. And like
Samule, Selgelid and Kerridges Managing the unimaginablegenomics of
2009 states, Scientists can have a significant role in theminimizes the
dangers. (pg.2) I think that rather it was intended or not, in the cases where
the negative impacts can be idealistically predicted, investigators should
thoroughly go through the problem which is one of the reasons why I think
hybrid usage of regulations is necessary.
1 http://www.thenewatlantis.com/publications/the-promise-and-perils-of-syntheticbiology

Even though some people argue that synthetic biology is safer than
genetically modified organism (GMO), there are claims that it is not free from
the biosecurity controversy. A. Bhutar suggests 4 expected dangers that
synthetic biology could potentially lead to.2 First, there is a possible danger of
destroying the environment when for example, releasing the synthetic
organisms to solve land pollution. Second, release of the introduced species
and synthetic plants also could damage the dielectrics of naturally bred
plants. And as for the different view on synthetic biologys problem, I believe
that the reason why there are such controversies on setting the regulations
on it is because people have different priorities in what they think is most
valuable. Then it leads us to the issue of fairness. For instance, lets say that
the vaccine to cure one disease has been produced by the synthetic biology
at low cost. It could surly benefit those who are suffering from that disease
but for people who have cultivation business of a medicinal herb of it will
lose what they make a livelihood out of. This is why I support the idea of
setting the regulations being so important because it shows that satisfying
every side of every kind of population is just as important as increasing the
overall quality of humans life with the scientific investigation. As I do not
think the burdensome of governmental institutions is necessary, scientists
and organizations realizing the importance of putting the humans
contentment before the financial or personal benefits would be the key to
2 http://www.synbiosafe.eu/uploads/pdf/Bhutkar_Synthetic%20Biology_Navigating
%20the%20Challenges%20Ahead.pdf

setting the appropriate regulatory policies to fulfill such blind points synthetic
biology may possess.
Synthetic biology has its purpose on saving lives by uniting the traditional
idea of biology and engineering approach together and is undeniable that its
impact on humans will be huge. The problem is whether it is positive or
negative. Even though I do not expect any immediate change in the form of
regulation we have, I wanted point out the importance of realizing the need
of discussing such technology before applying it. I do believe that starting
from predicting or even trying to find any potential harm through the process
of synthetic biology could minimize the negative effects on our lives. And
communicating with the mass should be a first step to finding ways of
starting hybrid regulatory system since public is the one that gets the most
impact from the investigation whether it would be positive or negative.

Works Cited
1. http://www.oeaw.ac.at/ita/en/projects/synbiosafe/overview
2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1490301/
Eckard Wimmer (2006), The test-tube synthesis of a chemical called

poliovirus: The simple synthesis of a virus has far-reaching societal

implications
3. http://www.museion.ku.dk/biohacking-web-exh/biohack-museum/
4. http://www.globalpolicyjournal.com/blog/23/04/2014/synthetic-biology-

what-expect-and-fear
Nayef Al-Rodhan (2014), Synthetic biology - what to expect and fear?
5. http://link.springer.com/article/10.1007/s11948-007-9043-

- Seumas Miller

1, 2

4/fulltext.html
and Michael J. Selgelid (2007), Ethical and

Philosophical Consideration of the Dual-use Dilemma in the Biological

Sciences
6. http://www.thenewatlantis.com/publications/the-promise-and-perils-of-

synthetic-biology
J. B. Tucker & R. A. Zilinkas (2006), "The promise peril of synthetic
biology
7. http://www.synbiosafe.eu/uploads/pdf/Bhutkar_Synthetic

%20Biology_Navigating%20the%20Challenges%20Ahead.pdf
A. Bhutar (2005), "Synthetic Biology: Navigation the Challenges Ahead"