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Synthetic Biology and Biodefense: Regulating the Unknown

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By Rebecca Cerio

The field of synthetic biology–most broadly described as the design and construction of new biological functions and systems not found in nature–has been quietly advancing ever since the discovery of restriction enzymes in the 1970s.  Being able to cut-and-paste DNA segments in combinations different than those created by nature opened the door to molecular biology and the burgeoning biotechnology field.  Such technologies, as well as our understanding of DNA functional and regulatory elements, now allow us to genetically engineer organisms to produce needed medicines, to bioengineer pest- and chemical-resistant food crops, and to sequence and study the genome of any organism for useful and harmful mutations.

Recently, the J. Craig Venter Institute’s announcement that they can chemically synthesize an entire, functional genome in the lab has led to new public awareness of the potential power, benefits, and dangers of synthetic biology.  One question raised is:  just because we can, does that mean that we should?
Or, from a regulatory standpoint, just because it is possible, should it be allowed?  Synthetic biology technology can be used for legitimate scientific purposes (i.e., producing vaccines) and to threaten public safety  (i.e., producing deadly pathogens).  But what are the actual, plausible risks and benefits of synthetic biology, beyond movie-plot scenarios and inflammatory rhetoric about “playing God”?

To answer these questions, President Obama charged his Presidential Commission for the Study of Bioethical Issues with recommending policies to enable development of synthetic biology’s full potential both ethically and safely.  The Commission’s report gives a readable and comprehensive summary of synthetic biology’s possible technological promise and ethical pitfalls.  Part of their overall conclusion was that:

“…synthetic biology is capable of significant but limited achievements posing limited risks.  Future developments may raise further objections, but the Commission found no reason to endorse additional federal regulations or a moratorium on work in this field at this time.  Instead, the Commission urges monitoring and dialogue between the private and public sectors to achieve open communication and cooperation.”

The Commission’s response highlights the difficulty of regulating the unknown.  Is it possible that synthetic biology can be put to ill uses in the future?  As with most scientific advances, synthetic biology technology could be abused.  However, synthetic biology can also be used for countless valid scientific and commercial purposes.  The Presidential Commission recognized synthetic biology’s potential benefits and urged the administration to allow the field to blossom (with monitoring) until concrete threats become clear.  It is a reactionary stance, but regulating technology too early may slow forward progress and innovation while guarding against only nebulous and possibly unlikely dangers.

The Commission gave eighteen recommendations for maximizing synthetic biology’s benefits while minimizing its risks.  Many of these recommendations focus upon building procedures and bodies to coordinate oversight.  The Commission gauged that there was little danger from synthetic biology in the near future.   However, the technology is advancing at such a rapid pace that “prudent vigilence” was required to keep a responsible finger on the pulse of the field.

For example, one of the current bottlenecks in synthetic biology is the relatively small number of companies offering large-scale DNA synthesis.  The cost of such synthesis is also still prohibitively expensive for many applications.  Currently, most DNA synthesis companies have adopted voluntary screening processes that monitor the sequences customers are ordering.  This process reduces the chances of a customer ordering sequences that could be used to synthesize  dangerous organisms.  However, if prices decrease to the point at which anyone can afford their own DNA synthesizer, new oversight mechanisms will be needed.  Likewise, other milestones such as advancing technologies or the rise of the largely unregulated do-it-yourself, or “DIY”, amateur biology community may also trigger a retooling of biodefence policy.

But who is in charge of doing that fine-tuning?  There is no dedicated government office or official responsible for coordinating biosafety monitoring.  Synthetic biology oversight is currently conducted by dozens of different agencies with varied focuses and agendas.  Therefore, attempting to implement the Presidential Commission’s recommendations will require forging a more centralized approach to technology oversight than is currently in place.  Maintaining these changes beyond the current administration will be an even greater challenge that politicians, scientists, and the public must all support.
“First Self-Replicating, Synthetic Bacterial Cell Constructed by J. Craig Venter Institute Researchers”.  Retrieved from  Accessed online October 29, 2011.

Presidential Commission for the Study of Bioethical Issues.  New Directions:  The Ethics of Synthetic Biology and Emerging Technologies.  Retrieved from  Accessed online October 29, 2011.

Miller, L.  “Who is in Charge of Biodefense?”  Biosecurity Blog.  Retrieved from .  Accessed online October 29, 2011.


Written by sciencepolicyforall

November 4, 2011 at 9:19 am

Posted in Essays

Tagged with , , ,

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