Grady Ku

02.24.2015
FRINQ Essay #2

Regulation, as Ive come to realize, is one headache of a topic. Whether its people
arguing for more regulation or less regulation (or no regulation), cases can be made for both
sides. But regulation over synthetic biology is another beast altogether. Following the surprising
truth that our current regulation standards held by APHIS, the FDA and the EPA have been
unscientific, a question arises: who do we trust with regulation? Do we continue to put our faith
in the aforementioned institutions even with their faulty standards? And what method do we use
to regulate? Reading through the regulation packet, there have been mentions of top-to-bottom
regulation, bottom-to-top regulation and even third party regulation. Also, aside from the
various regulation proposals, there is also the option of deregulation. In my opinion, I believe
some form of regulation is a necessity and that the degree of regulation should be moderate
enough for scientific freedoms to be supported, but with all of the legally binding components
intact. Throughout this essay, I will highlight the various pros and cons for each regulation
method, as well as deregulation, and attempt to uncover the middle ground upon which we
need to stand.
Let me begin with top-to-bottom regulation. As Miller pointed out in his article, the
standards by which the federal institutions deal with synthetic biology and genetically modified
organisms have been horrendously misplaced. To have an entire country put their trust into their
legislation only to receive a backhand to the face is quite insulting. Not only that, Miller also
reveals our GMO evaluation process has been disappointingly slow compared to that of other

countries. Taken from Miller and Kershen (2015): APHISs performance compares unfavorably
with its counterparts abroad. From January 2010 through June 2013, the average time from
submission to decision was 372 days for Brazil and 771 days for Canada, versus 1,210 days for
the United States. While faster isnt always better, when it takes 4 years just to get a GMO past
the evaluation phase, scientific progress becomes stifled to a point where there is little room for
mistakes. Science has and always will require countless trials and errors and unfortunately, our
current state of affairs is too inefficient and will reduce the margins for both. Quotes from Miller
and Kershen (2012): their approach was based on what has proved to be an idiosyncratic and
largely invalid set of assumptions that overestimated the novelty and potential risks and
unwilling to diminish their bureaucratic empires, the U.S. EPA and Department of Agriculture
have clung tenaciously to unscientic, burdensome, costly regulatory policies. Why is it that we
trust them to do their job when clearly they cant seem to do so? Especially on something as
sensitive as synthetic biology? However, one benefit to top-to-bottom regulation is that each
policy proposal will be reviewed without bias and without the use of value judgments. Still, from
what Miller had to say in his first piece, its obvious we need to take a different direction with
regulation and with all these problems associated with top-to-bottom regulation, why dont we
consider the opposite: bottom-to-top?
I believe that bottom-to-top regulation is perhaps the most volatile approach: it can be
either a huge success or a huge letdown. With nothing to guarantee the moral neutrality that the
federal government is held accountable by, discussions and debates surrounding proper
regulation regimes could become explosive. The scientists would make statements backed by
thorough research and the public would make counter-arguments based on their own opinions.
While the federal government will be overseeing the research, much of the battle will be between

the scientists and the public. In The Windup Girl, Gibbons was very much a scientist out for his
own gain. Given, he was working under Akkarat but with all of the knowledge he had, along
with access to the seedbank, he could have quite literally destroyed the world with his own
hands. The last thing we need in our world is to have many Gibbons who are out doing
research for their own means to an end. While Miller makes a good point that we are nowhere
near the level of playing God, I would have to counter-argue that it never hurts to tread very
carefully through deep waters. For example, the DIYBio idea (and by extension, iGEM) is great
for those aspiring to do more from the comfort of their homes however, all of the greatest
disasters in history has occurred from the conception of an idea which was then translated to
reality (i.e. Albert Einstein, a pacifist, helped create the atomic bomb, unaware at the time the
devastation that it would inflict upon the Japanese).
Thirdly, there is the third party regulation approach. Theres something about the term
third party that doesnt mesh well with the word regulation. Perhaps it has to do with the fact
that this third party would have diminished knowledge on the whole synthetic biology fiasco. As
much as it may seem appropriate to have regulation be done by a party that has no part in profits,
I feel that there is more at stake here than money. Even if institutions like J. Craig Venter try and
acquire patents for their synthesized organisms, monetary issues can be dealt with at a later time.
Not to mention, in Miller and Kershen (2012), Andrew Torrance says: For example, BioBricks
and iGEM actively promote biotechnology as an open source disciplineopen source movement
in biology, as in software, is antagonistic to corporate control and attempts to democratize the
inventive process in biology. With DIYBio and iGEM leading the front lines for open source
discipline, we are placed in a better spot. Additionally, third parties bring up questions of liability
when problems arise. Where can the public go to receive answers when a synbio experiment

goes haywire? Even if there was enough information exchanged between the researchers and the
third party for plausible answers to be given in times of question, I feel that public distress would
remain unchanged. One accident can go a long ways, especially in a field that is still in its early
years. I dont think synthetic biology supporters would want one accident to deface their
research. In any case, if third party regulation was ever to be a viable option, it would have to be
when synthetic biology as a field has been solidified to a point where the public would have no
trouble putting their trust in a third party. Conclusively, with these many flaws identified with the
different regulation methods, where does deregulation stand as an option?
Much like regulation, deregulation has its own set of problems to deal with. The most
notable issue with deregulation is in the fact that deregulation leaves all of the power to those
who wield it. Scientists can go into unchecked territory, leaving behind ethical/moral obligations,
for the sake of research. That is not to say that they will go to such measures, however,
deregulation always offers up the option to do so. With the latest read that researcher Guangwen
Tang, of Tufts University, had fed golden rice to Chinese kids as part of her research without the
consent of their parents, ethical safety has become a hotter issue in media. Whos to say that the
same wont happen with synthetic biology? Unless there is a safety net against such measures,
deregulation of synthetic biology shouldnt happen. The next question is, how do we get to a
point where both synthetic biology scientists and the public can be at terms? For the scientists,
deregulation would be all that they could have ever asked for but thats the last thing the public
wants. What is the driving force behind this conflict of interest? I believe that it is plainly fear
fear of the what ifs and fear of the unknown (even misplaced fear). In Pauwels article, he
reveals that much of the public are left in the dark when it comes to what synthetic biology
actually entails. Many have an idea of what it is but confuse it with other scientific fields; others

are trapped in their self-imagined sci-fi horror movies. Since this is the case, how do we resolve
this problem? Well first, the general public needs to understand the truths behind synthetic
biology (and in so doing, any erroneous information should be filtered out). After they are
informed, the next step lies in deliberative democracy.
I believe deliberative democracy, though it does seem a bit idealistic at face value, is the
best attempt at a level playing field. The public should be able to have an equal say in what
direction synthetic biology can go and where it cant go. Usually, policy making occurs after two
corporate giants clash on the legislative scene and to the victor goes the bill. However, with
deliberative democracy, all players will have an equal opportunity to get their voices heard. In
conclusion, there is more to be discussed than simply regulation methods. Synthetic biology is a
field that needs to be taken in stride with ethical issues, environmental safety issues as well as
human welfare issues. However, to tackle all of those elements at the same time would be
spreading ourselves too thin. For now, I have to agree with Miller and Selgelidwe need to be
in that sweet spot with regulation where academic freedoms are unstifled and public safety is
ensured. The first step towards that goal is putting information in the hands of the people, next
step is to introduce/initiate deliberative democracy, and the final step is to come to an agreement
that will satisfy most, if not all, players. And for the sake of Bacigalupis vision, I do hope that
the final verdict will be bottom-to-top regulation with half of the power in the publics hands.