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Synthetic Cells and Their Regulatory Challenges

Published online by Cambridge University Press:  20 January 2017

Justo Corti Varela
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Extract

On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

Type
Reports
Information
European Journal of Risk Regulation , Volume 1 , Issue 3 , September 2010 , pp. 259 - 263
Copyright
Copyright © Cambridge University Press 2010

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References

1 Daniel G. Gibson et al., “Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome”, Science 10.1126/science. 1190719, 20 May 2010.

2 Philip Ball, “A synthetic creation store”, Nature 10.1038/news.2010.261, 24 May 2010. Conf. Steen Rasmussen (Center for Fundamental Living Technology, University of Southern Denmark) and Jim Collins (Biomedical Engineering, Boston University), expressed at Nature “Sizing up the ‘synthetic cell’”, Nature 10.1038/news.2010.255, 20 May 2010.

3 See opinions of David Deamer (University of California) and Mark Bedau (Reed College, Oregon), expressed at Nature “Sizing up the ‘synthetic cell’”, Nature 10.1038/news.2010.255, 20 May 2010.

4 See the opinion of Steven Benner (Foundation for Applied Molecular Evolution, Florida), expressed at Nature “Sizing up the ‘synthetic cell’”, Nature 10.1038/news.2010.255, 20 May 2010.

5 Victoria Gill, “‘Artificial life’ breakthrough announced by scientists”, BBC piece of news, 20 May 2010, available on the Internet at http://news.bbc.co.uk/2/hi/science_and_environment/10132762.stm (last accessed on 30 June 2010).

6 See, for example, Alla Katsnelson, “Researchers start up cell with synthetic genome”, Nature 10.1038/news.2010.253, 20 May 2010. See also the opinion of Steven Benner (Foundation for Applied Molecular Evolution, Florida) expressed at Nature “Life after the synthetic cell”, Nature (465), pp. 422–424, published on 27 May 2010. Furthermore Prof. Martin Fussenegger (ETH Zurich in Basel) has clarified: “It is a technical advance, not a conceptual one” (opinion expressed at Nature “Sizing up the ‘synthetic cell’” op. cit.).

7 L'Osservatore Romano, 22 May 2010.

8 “In 2003, when we made the first synthetic virus, it underwent an extensive ethical review that went all the way up to the level of the White House”; “And there have been extensive reviews including from the National Academy of Sciences, which has done a comprehensive report on this new field”; “We think these are important issues and we urge continued discussion that we want to take part in”, opinions of Prof. Craig Venter expressed in Victoria Gill, “‘Artificial life’ breakthrough announced by scientists”, op. cit.

9 See, for example, the opinion of Dr Helen Wallace (Genewatch – UK): “If you release new organisms into the environment, you can do more harm than good (…). By releasing them into areas of pollution, [with the aim of cleaning it up], you're actually releasing a new kind of pollution”, expressed in Victoria Gill, “‘Artificial life’ breakthrough announced by scientists”, op. cit.

10 Pallab Ghosh, “Synthetic life patents ‘damaging’, BBC piece of news, 24 May 2010, available on the Internet at http://news.bbc.co.uk/2/hi/science_and_environment/10150685.stm (last accessed on 30 June 2010). See also Sarah Chan and John Sulston, “Patents in synthetic biology may hinder future research and restrict access to innovation”, British Medical Journal, 340:c2984 (14 June 2010).

11 At that time Craig Venter led a private sector effort which aimed to charge for access to the information and, by contrast, John Sulston was part of a government and charity-backed effort to make the genome freely available to all scientists.

12 Conf. Nature “Challenges of our own making”, Nature (465), p. 397 (27 May 2010).

13 This is the main cause of disputes, in terms of regulation, between the EU and the US. The scientific study that declared the substantial equivalence came early: National Research Council “Field Testing Genetically Modified Organisms: Framework for Decisions” (National Academy Press: Washington 1989).

14 Discussions concerning these two points of view are very well explained in Jasanoff, S., “Product, Process, or Program: Three Cultures and the Regulation of biotechnology”, in Bauer, M. (ed.), Resistance to New Technology: Nuclear Power, Information Technology, and Biotechnology (Cambridge University Press: Cambridge 1995).Google Scholar

15 This clause was introduced in 1959 by Congress member James Delaney, whose wife had died from cancer: “the Secretary of the Food and Drug Administration shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals”. In 1988 the EPA relaxed restrictions over pesticides including some tolerance thresholds. Finally it was derogated in 1996. See Merrill, R., “Food Safety Regulation: Reforming the Delaney Clause”, 18 Annual Review of Public Health (1997), pp. 313–340.CrossRefGoogle ScholarPubMed

16 For a good description of the Congress debate see D. Vogel, “Ships Passing in the Night: GMOs and the Politics of Risk Regulation in Europe and the United State”, Working Paper 2001/16, European University Institute Florence, p. 10.

17 FDA “Statements of policy: foods derived from new plant varieties”, Federal Register, 57 RF 22984, 1992.

18 Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ No L 117 of 8. 5. 1990, p. 1).

19 Directive 90/219/ECC, Art. 2: “genetically modified micro-organism shall mean a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.”

20 Directive 90/219/ECC, Annex II.

21 For a detailed description of the context of the Asilomar Conference see Kourilsky, P., “Les manipulations génétiques in vitro: compte rendu de la Conférence de Pacifique Grove”, 57 Biochimie (3) (1975), pp. vii–xv Google Scholar

22 Ferber, Dan, “Synthetic biology. Time for a synthetic biology Asilomar?”, Science (303), pp. 159–159, 9 January 2004.Google ScholarPubMed