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Christian Garabato
Flower/Hernandez
Life Unlimited
3/10/15

Throughout humanity we have constantly been altering things like plants and
animals in order to better our living. Back then it was something as simple as making
certain animals breed with each other in order to obtain an offspring that has good traits
that the mother and father dont have together. Now it is much more different. We are
using technology in order to synthesize and create new genes to import into an
organism. The problem with this, is that not everyone is ok with playing god so many
regulatory agencies have been created to make sure everything doesnt get out of hand.
At least thats what people believe, but could too much safety and regulation possible
stunt the growth of further development?
Synthetic Biology is a discipline of science that involves creating or altering
genetic codes. Everyone and everything has a set of instructions that makes them what
they are and what synthetic biology does is create, change, import or even export
different genes in order to alter and create a perfect or near perfect product.
Although there is broad public and professional support for scientic research, it
is also generally accepted that research should operate within acceptable social norms
and should not unreasonably threaten public safety or impose unacceptable social
burdens. The challenge for regulators in relation to synthetic life science is to devise a

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legislative and regulatory system that balances security and safety risks to facilitate
research without imposing unreasonable bureaucratic burdens on scientists and
academic freedom. (Samuel, Selgelid, and Kerridge, pg. 1) With that being said the
article then informs the reader about different techniques and systems that can regulate
the practice of genetic engineering. Within the research community, scientists are more
drawn to a method of self-governance. They believe that this would be a more effective
method rather than to have a sort of legislative binding. Within the practice they take a
lot of safety measures not to reach any standard implemented by legislative binding, but
because it is simply for safety and functionality. However Critics of self-governance
dismiss such proposals as inadequate. They 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. (Samuel, Selgelid, and Kerridge,
pg. 1) These critics believe that the scientists and engineers implementing the research
may become corrupt and not obey every rule in order to make a profit. These critics
support heavy government regulation, but such regulation could actually be damaging
to the progress of Synthetic Biology.
The opportunity costs of unnecessary regulatory delays and inated
development expenses are formidable. As David Zilberman, an agricultural economist at
the University of California, Berkeley, and his colleagues have observed, The foregone
benets from these otherwise feasible production technologies are irreversible, both in
the sense that past harvests have been lower than they would have been if the
technology had been introduced and in the sense that yield growth is a cumulative
process of which the onset has been delayed. (Miller and Kershen (2015), pg. 5) The

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end of this article mentions opportunity cost a lot. It is true that all the delays from heavy
regulations such as processes implemented by APHIS that could take years to
complete, have done nothing but prevent people around the world from benefitting.
What really blows my mind is that the process is very biased. Various engineered
organisms are not put under an extensive process of regulation because of the
characteristics of the organism, but because the organism was simply engineered and
developed with new techniques. Research organizations claim that the newer
techniques are more precise and can help better predict how an organism will react
when a new gene is introduced and or introduced to a new environment. With more
than 30 years of development of these modern techniques, they have become even
more refined. This statement doesnt affect regulatory agencies though. Instead they
choose to round up the entire genetically engineered organism and regulate all of them
just because of the technique used to obtain them. Thus, there has been a broad
consensus in the scientic community, which has been reected in statements of federal
government policy going back more than 25 years, that the newest techniques of
genetic modication are essentially an extension, or renement, of older, less precise,
and less predictable ones, and that oversight should focus on the characteristics of
products, not on the processes or technologies that produced them. (Miller and
Kershen (2015), pg. 2). It is silly that time consuming and expensive regulatory
processes are being forced upon various genetically engineered organism just because
they were developed in a more precise and predictable way than they were about 20+
years ago. In the article an example of this is brought up. EPA regulatory net captures
pest-resistant plants only if the protectant has been introduced or enhanced by the

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most precise and predictable techniques of genetic engineering. (Miller and Kershen
(2015), pg. 4). To me that seems fairly unreasonable. Anything that is selected to be
heavily regulated and tested should be because of the characteristics of the genetically
engineered organism and the technique used to make them. In this case it is a more
precise technique which sounds more comforting than a technique used 20+ years ago.
This brings up another point made by Miller and Kershen. This approach, which has
been condemned repeatedly by the scientic community over many years, has
discouraged innovation and provided incentives for the developers of new plant
varieties to use inferior but unregulated techniques. (Miller and Kershen (2015), pg. 4)
Science revolves around new development and innovation. How can these synthetic
biologists operate and push the limits of life when all they can work with is inferior
equipment. Of course they can use the more advanced and precise techniques, but
what is the point of that when whatever is developed is simply captured in a net and not
released to the public for years and years if it is even released at all. Some people
believe that all the technology and tools used to create these genetically modified
should be prohibited all together. They think that they shouldnt waste time on regulating
the products but to just regulate the tools creating the product in order to stop the
product from occurring in the first place. Prohibition, however, would inhibit intellectual
inquiry and scientic freedom, and would prevent any possible benets from synthetic
genomics and synthetic biology being realized. (Samuel, Selgelid, and Kerridge, pg. 2)
Scientists cant be limited to what they can use because their whole purpose is to
discover something new and make developments to better humanity.

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Earlier in this essay Samuel, Selgelid, and Kerridge expressed their views on
self-governance and full government control. Although their views may seem to be
leaning to a more self-governance system, they actually believe in a hybrid system. A
mix of institutional control and government control. This system would be able to appeal
to scientific freedom and also appeal to biosecurity and biosafety. I personally think that
this is the best and most fair way to go about regulation.
Like I said before I believe that a hybrid system would be the most efficient way
of going about regulation. A system of checks and balances would be the most fair and
less restricting on scientific freedom. I still think that a good amount of field tests and
regulation is necessary but not any type of process that would take years and years and
millions of dollars. I also think its really stupid how these regulatory agencies have this
blanket opposition to all genetically modified organisms that were developed in new
advanced ways. I strongly agree with regulating something for its characteristics and
not because of the technology used to create it. To me that is just a waste of time and
money. When it comes to the opportunity cost I feel that all the wasted time from
regulatory agencies couldve have been used to either develop even greater organisms
or even release finished products to the market. Under its discriminatory and
unscientic regulatory regime, APHIS has approved more than 90 genetically
engineered traits, and farmers have widely and quickly adopted the crops incorporating
them. (Miller and Kershen (2015), pg. 3) These traits went under long extensive
process to be released to the public and it is clear that people are willing to use them.
Imagine what would happen if didnt take so long.

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In conclusion, it is clear that not everyone is comfortable with complete scientific

freedom and would like some sort of regulation. Biosecurity and Biosafety is without a
doubt very important and cant be overlooked because someone wants a super potato.
The most fair and efficient way to go about regulation is to have a hybrid system. A
system of checks and balances could greatly benefit the field of synthetic biology. Even
with heavy regulations, scientists continue to make breakthroughs with little to no
scientific freedom with the type of equipment that can be successfully used to create a
product that can be released to the public. With that being said a perfect balance of
regulation and freedom could change the world in a good way very quickly.

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CITES
Miller, H., & Kershen, D. (2012, August 29). Will Overregulation In Europe Stymie
Synthetic Biology? Retrieved March 3, 2015.
Miller, H., & Kershen, D. (2015, February 6). Give Genetic Engineering Some
Breathing Room Government regulations are suffocating applications with great
promise. Retrieved March 3, 2015.
Samuel, G., Selgelid, M., & Kerridge, I. (2009). Managing the unimaginable:
Regulatory responses to the challenges posed by synthetic biology and synthetic
genomics (pp. 7-11). EMBO Reports.