Sloan Group Re-worked Synthetic Biology Chapter

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cHAPtEr 35

Synthetic Biology

Mihele S. Gafkel, dew Ey, Geal L. Epsei, a robe M.Fiema, “Syhei Biology,” i

From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefng Book or Journalists, Policymakers,and Campaigns

, e. May cowley (Gaiso, nY: the Hasigs cee,2008), 163-168.

©2008, the Hasigs ceeAll ighs eseve. no pa o his book may be epoue, soe i a eieval sysem, o asmiei ay om o by ay meas (eleoi, mehaial, phooopyig, eoig, o ohewise), wihouhe pio wie pemissio om he publishe, exep o he ilusio o bie quoaios i a eview.We have aempe o povie omplee a auae iomaio egaig he iiviuals, ogaizaios,a ageies esibe i his book. Howeve, we assume o liabiliy o eos, omissios, o amagesaisig om he use o his Biefg Book.

tHE HAStInGS cEntEr

o Joualiss, Poliymakes, a campaigs

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ioethics

B

riefing

B

ook

from

Birth

to

death

and

Bench

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clinic

SyNTHETIc bIOLOGy

163

synthetic biology

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Sntheti iolog helps solve iologialengineering prolems  adapting engi-neering onepts to design and reonstrutnew iologial parts, or redesign existing,natural iologial sstems.

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Sntheti iolog also allows sientists toquil onstrut new geneti designs thatdiretl test their hpotheses.

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Sntheti iolog revisits safet and seuri-t onerns first identified with the inventionof reominant DNA tehnolog. Similarl,sntheti iolog raises oth familiar andnew soial and ethial questions.

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Some enefiial appliations of snthetiiolog ould also e used in harmful or unintentionall dangerous was.

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The onstrution of minimal organismsraises distint ethial questions, suh ashow or whether suh wor hanges theonept of what life is.

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Researh suggests that sntheti iologma soon e a tehnolog of hoie for anation or ioterrorist hoping to develop or aquire a pathogen for use as a weapon.

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Other issues inlude the potential impat of organisms reated  sntheti iolog onthe environment, the ownership of teh-nologies, and distriution of the enefits of suh researh and its produts.

Framing the Issue

Using a number of technologies and intellectual approaches,synthetic biology solves biological engineering problems bydesigning and reconstructing new biological parts, or systemati-cally redesigning existing, natural biological systems. Implicit inthis process are some as-yet unresolved issues for policymakers.For example, some applications of synthetic biology that benefitsociety could also be applied in ways that can harm it, or thatcould be unintentionally dangerous; the use of such technologiesin the development of a biological weapon, such as a virus, is anobvious concern. But also of concern is that scientists who arecarrying out legitimate experiments could without malice con-struct an organism with disease-causing potential.The issue of safety is further complicated because applicationsof synthetic biology that are considered beneficial by some may be perceived as harmful or dangerous by others. Perhaps the best-studied example of this sort of disagreement is that of theintroduction of genetically engineered (often referred to as“genetically modified”) food crops. Use of these crops may bring benefits, such as the possibility of using less pesticide, yet manyconsider any such modification to be inherently harmful in theabsence of compelling evidence to the contrary.Discussion and debate regarding these issues need to engagepractitioners (including students), policymakers, research admin-istrators, and commercial providers of raw materials for theresearch, both among themselves and in conjunction with adiverse range of interested citizens and civil organizations.

Background and Science

The concept of synthetic biology as an approach to biologicalengineering dates to the mid-1970s when the advent of readilyavailable enzymes and other materials allowed pieces of DNA to be easily swapped between organisms. The last 10 years have been a time of tremendous improvement in the ease of specifictechniques associated with synthetic biology, and this, along withrapidly falling costs and the dispersion of experimental approach-es once thought to be the domain of elite biologists, has resultedin the dissemination of synthetic biology widely (among sectorsand academic approaches) and deeply (from Nobel Prize winners

s y n t h e t i c b i o l o g y

 Mihele S. Garfinel, Drew End, Gerald L. Epstein, and Roert M. Friedman

Michele S. Garfinkel, PhD,

is a policy analyst for the J. Craig Venter Institute,

Drew Endy, PhD,

is assistant professor of synthetic biology at Stanford University,

Gerald L. Epstein, PhD,

is a senior fellow for science and security for the Center for Strategic and International Studies, and

Robert M. Friedman,PhD,

is deputy director for California at the J. Craig Venter Institute.

HIGHLIGHTS

Michele S. Garfinkel, PhD,

Policy Analyst,J. Craig Venter Institute

•mgarfinel@ jvi.org, 301-795-7413

Drew Endy, PhD,

Assistant Professor,Synthetic Biology, Stanford

•

end@stan-ford.edu, 650-498-6135

Gerald L. Epstein, PhD,

Senior Fellow for Science and Security, Center for Strategic and International Studies

•gepstein@sis.org, 202-775-3125

Robert M. Friedman, PhD,

Deputy Director for California, J. Craig Venter Institute

•rfriedman@jvi.org, 301-795-7390

Gregory E. Kaebnick, PhD,

ResearchScholar, The Hastings Center

•aenig@thehastingsenter.org, 845-424-4040, x227

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X P E R T S T O

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THE HASTINGS cENTER bIOETHIcS bRIEFING bOOk

to high school students). Recent results of suchexperiments include:

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The construction of an infectious poliovirusgenome from oligonucleotides (short frag-ments of DNA that are strung together in the laboratory)

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The reconstruction of bacteriophage T7 tosimplify its genome (demonstrating that natu-rally occurring genomes can be systematicallyredesigned and rebuilt for further research orfor specific applications)

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The synthesis of a 582,970-base-pair genomeof Mycoplasma genitalium (showing that thefull genome of a replicating organism can beconstructed in the laboratory)

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Practical applications, including an attempt toproduce artemisinin, the precursor to themalarial drug artemisin, that are very close tosucceeding. Although other biotechnologies could in manycases be applied to essentially the same purposes,the combination of easy access to synthesizedDNA, powerful computers to aid design, and thedistribution of these technologies to users beyondthe “traditional biologist” have raised unique safetyand security concerns about synthetic biology.Further, the idea of using these technologies to con-struct living organisms has sparked discussionsabout whether the use of these technologies is ethi-cal and, beyond that, what “creating life” means.Ensuring that this field develops in a responsiblemanner, respectful of society’s desires and beliefs,will require some combination of training, over-sight, and community external or self-regulation,constructed to allow the science and engineering toadvance without compromising safety, security, orsociety’s values.

Ethics, Society, and Synthetic Biology

We discuss here five major areas of concernwith respect to the societal impacts of research inand applications of synthetic biology. Theseinclude biosafety and biosecurity; the environ-ment; ownership; philosophical and theologicalissues; and the professional conduct of researchers.Some of these issues have been very well analyzed;for others analysis is just beginning. Each is out- lined below.

Biosafety and biosecurity.

A key set of tech-nologies for synthetic biology is the construction of DNA in the laboratory from its constituent chemi-cals. Often referred to as “DNA synthesis,” “genesynthesis,” and “synthetic genomics,” this set of technologies makes it possible to build DNA of anyspecified sequence and length, up to the size of awhole genome. The biosafety and biosecurityimplications have been explored by the authorsand others in some detail (in “Resources” box, seeGarfinkel et al., National Science Advisory Boardfor Biosecurity, and Tucker and Zilinskas).For our 2007 study, a working group of expertsin the technologies of DNA synthesis, researchapplications of DNA synthesis, engineering, policy, law, ethics, and sociology conducted a technologyassessment of synthetic genomics. Over 20 months,we systematically explored the potential risks and benefits of synthetic genomics; the technologiesthat currently exist for carrying out the research;and the technologies that may be available in fiveto ten years. The analyses aimed to identify the benefits and risks that were specific to syntheticgenomics as opposed to biotechnology generally.We found that, with very few exceptions, syn-thetic genomics would not now be the technologyof choice for a bioterrorist or nation-state hoping todevelop a virus for use as a weapon. Within five toten years, however, it may very well be the casethat synthesis will be easier than other means of obtaining a virus.Based on these qualitative analyses, we con-structed a list of 17 possible options for gover-nance, focusing on the commercial suppliers of DNA; the machines and reagents that can be usedto synthesize DNA in laboratories; and the legiti-mate users of these technologies, including theirassociated organizations, such as universities.These options range from requiring that firmsscreen every order for potential malicious intent toextending the mandate of institutional biosafetycommittees to consider the potential securityimplications of experiments.Commercial firms that make and sell syntheticDNA have in fact already recognized that they havea role in assuring the safety of researchers andcommunities nearby and the security of all. Severalfirms have together formed the InternationalConsortium for Polynucleotide Synthetics (ICPS).ICPS members and others have published a poten-tial oversight framework for the development andimplementation of sequence screening tools andmechanisms for reporting and resolving concernsabout orders of potentially dangerous sequences.

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