What is synthetic biology?

1. Synthetic Biology and SecurityAlison McLennanPhD Candidate College of Law Australian National University

2. What is synthetic biology? ‘Synthetic biology is a) the design and construction of new biological parts, devices and systems, and b) the re-design of existing natural biological systems for useful purposes.’ SyntheticBiology.org

3. Pandora’s bug? http://www.etcgroup.org/en/materials/publications.html?pub_id=631

4. Regulating gene synthesis-Various voluntary guidelines and statements • Draft Declaration of the Second International Meeting on Synthetic Biology, Berkeley, California USA May 2006 • Harmonized screening protocol: Gene sequence and customer screening to promote biosecurity, International Gene Synthesis Consortium, November 2009 • Screening Framework Guidance for Synthetic Double-stranded DNA, released for public comment by the US Dept Health and Human Services, November 2009

5. The synthetic cell www.jcvi.com

6. Media storm: man creates life! The Economist

7. From The Economist ‘The result is the first creature since the beginning of creatures that has no ancestor. What it is, and how it lives, depends entirely on a design put together by scientists of the J. Craig Venter Institute and held on the institute’s computers in Rockville, Maryland, and San Diego, California. When the first of these artificial creatures showed that it could reproduce on its own, the age of artificial life began.’ ‘Creating life is no longer the prerogative of gods.’

8. From The Economist Pedants may quibble that only the DNA of the new beast was actually manufactured in a laboratory; the researchers had to use the shell of an existing bug to get that DNA to do its stuff. Nevertheless, a Rubicon has been crossed. It is now possible to conceive of a world in which new bacteria (and eventually, new animals and plants) are designed on a computer and then grown to order.

9. Security concerns raised: • ‘Noting the propensity of computer-hackers to turn out what have been dubbed, by analogy, software viruses, they worry that hackers of the future may turn to synthetic biology and turn out real viruses.’ • The Economist

10. Then: http://www.whitehouse.gov/photos-and-video/photogallery/remarks-president-health-care

11. President Obama’s letter On 20 May 2010, President Obama asked the Presidential Commission for the Study of Bioethical Issues: • ‘to undertake, as its first order of business, a study of the implications of this scientific milestone, as well as other advances that may lie ahead in this field of research.’ • to consider ‘the potential medical, environmental, security, and other benefits of this field of research, as well as any potential health, security or other risks.’ • to ‘develop recommendations about any actions the Federal Government should take to ensure that America reaps the benefit of this developing field of science while identifying appropriate ethical boundaries and minimizing identified risks.’ ‘it is vital that we as a society consider, in a thoughtful manner, the significance of this kind of scientific development’.

12. US House of Representatives: Committee on Energy and Commerce Hearing Effects of Developments in Synthetic Genomics and Implications for Energy and Health 27 May 2010

13. Leaders in synthetic biology Drew Endy J Craig Venter Jay Keasling

14. Dr Venter ‘We, I think almost unprecedented in science, asked for ethical review of this research before we did the first experiments. . . we have had ongoing discussion, trying to drive the discussion. . . the reports have been published looking at the security. . . So the scientists, I think, not only are being responsible, we are asking the questions before anyone else has’.

15. Dr Fauci ‘Without even going near synthetic biology, the possibility of doing really bad things exists. The bad guys are not going to listen to any rules. They are going to do what they want. They do not even need this technology...’ ‘Do not over-regulate something that needs care and responsibility and integrity and work with us in making sure we lay the foundations, that that transparency, integrity and responsibility are there.’

16. Mr Barton • ‘Their version is a little jazzier than the original, apparently. It is blue and includes the scientist’s names in code. I want the next one to be red. Okay? You have done one for the blue side; now do one for the red side.’ • ‘I do hope they discover a way to create a synthetic genome that would predispose folks to vote republican!’

17. WMD Prevention and Preparedness Act of 2010 ‘Section 203: Dual Use Terrorist Risks From Synthetic Genomics: a) Sense of Congress It is the sense of Congress that the field of synthetic genomics has the potential to facilitate enormous gains in fundamental discovery and biotechnological applications, but it also has inherent dual use homeland security risks that must be managed.’ • The Secretary of Homeland Security is directed to look into the homeland security implications of the dual use nature of synthetic genomics, and if necessary to do research into matters such as the capability of synthetic DNA providers to distinguish between legitimate customers and potential terrorists or malicious actors, and to effectively screen orders for sequences of security concern. • They are to make recommendations about screening protocols and any other capability gaps that they may find in the study.