Synthetic Biology: Benefits, Risks, and Regulations

Our species has grown increasingly adept at harnessing the natural world for our benefit; however, for the past few decades, genetic engineers have only been able to manipulate genes. While engineers build computers and buildings entirely from scratch, bioengineers tinker with already-existing biological systems by isolating, replicating, and inserting fragments of DNA. [1] Recently, researchers in the rapidly growing field of synthetic biology have approached bioengineering from a different angle that some call “extreme genetic engineering [2].” By envisioning biological systems as complex machines, synthetic biologists construct new biological parts or systems and re-construct existing ones by using DNA as software that creates its own hardware [1, 3].

Recent studies estimate value of the synthetic biology industry to rise in value to $10.8 billion by 2016 from $1.6 billion in 2011 [4]. As a result, governments around the world have pegged this field as a future major industry and have allocated funds accordingly [5]. According to a Woodrow Wilson International Center for Scholars report, the U.S. and Europe invested $590 million in synthetic biology from 2005 to 2010 [5].

The large amount of investment in synthetic biology reflects confidence in its potential to revolutionize other fields, such as sustainable energy. In hopes of one day replacing fossil fuels, researchers have improved biofuel technology by synthetically arranging existing proteins into new pathways to create organisms with novel functions not found in nature [3, 6]. For example, microbes have been engineered to create higher-yield fuels such as butanol and biodiesel products that can directly replace petroleum [3, 6]. Microbes and algae can also be modified to produce fuels directly from carbon dioxide and sunlight, reducing carbon emissions [3, 6].

A more futuristic and ambitious goal is the creation of synthetic life, which could help us better understand life itself. As famous Nobel-Prize winning physicist Richard Feynman wrote, “What I cannot create, I do not understand [7].” By building biological systems, we can test and confirm current biological models and perhaps even form new ones. Recently, synthetic life took a step forward when researchers at the J. Craig Venter Institute announced the creation of the first synthetic self-replicating bacterial cell [8]. Another project underway is the Minimal Genome Project, which aims to identify the minimal genes needed for cell operation [9]. The project would make manipulation of the organism for human benefit much easier than modifying existing pathways in natural cells. Modified organisms could then be used for a variety of purposes, from production of chemicals to cleaning up oil spills [9].

The awe-inspiring benefits come with equally grave risks. Like many emerging fields, synthetic biology brings its own set of questions about safety and ethics. The prospect of accidental release of genetically modified organisms has often been the subject of controversy. There are so many variables concerning the release of synthetic organisms that the consequences are unknown and potentially devastating. Some of the scenarios envisioned include the evolution of a novel, deadly pathogen or the extinction of existing organisms today due to competition with synthetic organisms [2, 10].

In addition to accidental release, the possibility of intentional release also sparks opposition. Synthetic biology makes bioterrorism a more viable option for hostile organizations [11]. With synthetic biology, only DNA and a host cell is needed to assemble a pathogen. This fact was brought to light in 2002, when researchers led by Dr. Eckard Wimmer successfully synthesized poliovirus by piecing together DNA strands and inserting them into a mouse. [2] The findings are especially frightening when considered alongside the relative ease with which DNA sequences may be obtained. One journalist was able to personally order and receive part of the smallpox virus sequence from a company. [11] According to a 2008 Hastings Center report, “Within five to ten years […], it may very well be the case that synthesis will be easier than other means of obtaining a virus [12].”

In the wake of forays into synthetic life, some groups have accused scientists of “playing God [13].” To secular observers, synthetic biology appears to be yet another example of humanity tampering with things we do not understand [13]. Scientists challenge the already fragile definition of life by trying to build synthetic cells ; by “creating” cells from inanimate materials, the boundaries between ife and machine begin to blur, raising even more questions. Should we objectify life? Can we assign it a monetary value? Should we do away with the distinction altogether?

In 2010, the Presidential Committee for the Study of Bioethical Issues released a list of recommendations and possible mechanisms of regulation. Mainly, it recommended further analysis of licensing practices, risks of release, possible mechanisms of containment, and current regulations on manufacturers involved in synthetic biology. For ongoing research, it proposed the integration of “suicide genes” in the genomes of synthetic organisms that would either set life span limits or create a dependency on nutrients specific to the lab [14].

Some groups argue that the safeguards are not enough; since scientists do not completely understand how life works, they cannot guarantee that suicide genes will work [15]. The Ethics committee, recognizing the unpredictability of the field, recommended periodic security and safety risk analyses as well, calling for mandatory “reporting measures” for all researchers if synthetic biology emerges as a threat [14].

At the same time, scientists in the field recognize need for new regulations now. The Synthetic Biology Engineering Research Center (SynBERC), funded by the National Science Foundation, advocates regulation specific to synthetic biology [16]. One proposal would closely regulate all nucleic acids that share 15 percent of the genome of a pre-defined list of viruses. Such regulation, however, could prove burdensome to fields other than synthetic biology, such as virology. Another similar proposal is to regulate organisms that contain genes from a pre-defined list of dangerous genes. Like the other proposal, regulations may restrict other fields by targeting organisms that are not harmless at all. The list would also have to be updated frequently to accommodate new dangerous genes [16].

On one hand, synthetic biology may hold the answers to some of today’s most pressing issues; on the other, it may be the source of our worst nightmare. A system of regulations, although difficult to implement, is essential in order to safely reap synthetic biology’s social and economic benefits. In the meantime, with or without regulation, synthetic biologists unravel and redesign the phenomenon of life.

1. What is synthetic biology? [Internet]. Berkeley (CA): Synthetic Biology Engineering Research Center; [cited 2012 Nov 28]; [about 2 screens]. Available from:
2. ETC Group. Extreme genetic engineering: an introduction to synthetic biology [Internet]. [Durham (NC)]: ETC Group; 2007. 64 p. Available from:
3. Venter CJ. Craig Venter: on the verge of creating synthetic life [Internet]. Presentation presented at: TED2008; 2008 Feb 27-Mar 1; Monterey, CA. Available from:
4. UK Synthetic Biology Roadmap Coordination Group. A synthetic biology roadmap for the UK [Internet]. Technology Strategy Board (UK): 2012. 33 p. Requested by UK Department for Business Innovation and Skills. Available from:
5. Woodrow Wilson International Center for Scholars. Trends in synthetic biology research funding in the United States and Europe [Internet].  Washington (DC): Woodrow Wilson International Center for Scholars; 2010. 9 p. Available from:
6. Connor MR, Atsumi S. Synthetic biology guides biofuel production. J Biomed and Biotechnol [Internet]. 2010 July 5 [cited 2012 Nov 28];2012(1):[9 p.]. Available from:
7. Porcar M, Danchin A, de Lorenzo V, dos Santos V, Krasnoggor N, Rasmussen S, Moya A. The ten grand challenges of synthetic life. Syst Synth Biol [Internet]. 2011 June [cited 2012 Nov 28];5(1-2):1–9. Available from:
8. J. Craig Venter Institute [Internet]. Rockville: J. Craig Venter Institute. First self-replicating synthetic bacterial cell; 2010 May 20 [cited 2012 Nov 28]; [about 3 screens]. Available from:
9. Forster AC, Church GM. Towards synthesis of a minimal cell. Mol Syst Biol [Internet]. 2006 August 22 [cited 2012 Nov 28];2(1):[about 10 p.]. Available from:
10. Balmer A, Martin P. Synthetic biology: social and ethical challenges [Internet]. Nottingham (UK): The Institute for Science and Society, University of Nottingham; 2008. 36 p. Requested by Bioscience for Society Panel of the iotechnology and Biological Sciences Research Council. Available from:
11. Maurer SM, Lucas KV, Terrell S. From understanding to action: commnity-based options for improving safety and security in synthetic biology [Internet]. Berkeley (CA): Goldman School of Public Policy, University of California at Berkeley; 2006. 23 p. Available from:
12. Garfinkel MS, Endy D, Epstein GL, Friedman RM. Synthetic biology. In: Crowley M, editor. From birth to death and bench to clinic: The Hastings Center bioethics briefing book for journalists, policymakers, and campaigns [Internet]. Garrison (NY): The Hastings Center; 2006 [cited 2012 Nov 28]. p. 163-8. Available from:
13. Douglas T, Savulescu J. Synthetic biology and the ethics of knowledge. J Med Ethics [Internet]. 2010 November [cited 2012 Nov 28];36(11):687-693. Available from:
14. Presidential Commission for the Study of Bioethical Issues. New directions: the ethics of synthetic biology and emerging technologies [Internet]. Washington (DC): Presidential Commission for the Study of Bioethical Issues; 2010. 178 p. Available from:
15. Tucker JB, Zilinskas RA. The promise and perils of synthetic biology. New Atlantis [Internet]. 2006 [cited 2012 Nov 28];12(1):25-45. Available from:
16. Byers J, Casagrande R (Gryphon Associates, Takoma Park, MD). The regulation of synthetic biology: a concise guide to U.S. federal guidelines, rules and regulations [Internet]. [Berkeley, CA]: SynBERC (US): 2010.  19 p. Funded by NSF. Available from:

Image Credit: Knowles M. Lego DNA [photograph]. Tacoma (WA): Wikimedia Commons [Internet]; 2003. 1 photograph: color, 1,280 × 960 pixels. Available from:

Leslie Tzeng is a student at The Harker School. Follow The Triple Helix Online on Twitter and join us on Facebook.