SYNTHETIC BIOLOGY

Advances in synthetic biology, genomics, gene editing and information technology raise the risk that commercial producers of synthetic genomes might be used unwittingly to assist in the production of designer biological weapons.  The technology is not currently widely available, but may be with us sooner rather than later with the expected advent of DNA printers.

 

To address this issue, two industry associations (the International Association for Synthetic Biology, IASB and the International Gene Synthesis Consortium, IGSC) created independent codes of conduct based on customer screening, gene sequence screening, record keeping and points of contact with law enforcement.  Subsequently, the US Department of Health and Human Services (DHHS) issued guidelines on the production and sale of synthetic genes. 

 

The ICLS Synthetic Biology Project aimed to organize and participate in a series of meetings in order to address the following: practical issues of implementing the codes; the creation of a ‘seal of approval’ for those implementing the codes; how to promote universal adoption of the codes globally; how to expand the concept of the codes to others involved in synthetic biology, such as academics, citizen scientists and corporations with in-house synthetic biology capabilities; whether existing legislation was sufficient to ensure that only safe applications of synthetic biology receive product approval; and whether there was a need for a global forum to the regular discussion of these issues, coordination of responses to them and horizon scanning to ensure that newly emerging issues receive timely and appropriate consideration and action.

 

ICLS, in conjunction with the IASB and the IGSC, and the US Federal Bureau of Investigations (FBI) convened a meeting of industry representatives, government officials, academics, NGOs, international agencies, clients of the gene synthesis industry and citizen scientists in Heidelberg, Germany in March 2012.  The meeting addressed practical issues of implementing the codes, the creation of a ‘seal of approval’ for those implementing the codes, and how to promote universal adoption of the codes globally.  It also addressed how to expand the concept of the codes to others involved in synthetic biology, such as academics, citizen scientists and corporations with in-house synthetic biology capabilities. 

ICLS then participated in a meeting in Shanghai, China in August 2012, organized by the Monterey Institute with funding from the US State Department, to raise awareness amongst Chinese synthetic biology corporations of the security implications of synthetic biology.  This meeting resulted in a call, from Professor Guoping Zhao of the Shanghai Institute for Biological Studies and Dr. Zhu Li of GenScript, for the formation of a Chinese Synthetic Biology Association and the adoption of its own code of conduct. 

The last meeting was held in Hong Kong 7-8 March 2013.  It was a follow up to the meeting held in Heidelberg in March 2012, which addressed security issues as they apply to gene foundries and commerce in synthetic genes.  The meeting sought to globalize the discussion and conclusions of the Heidelberg meeting and to deal with broader security issues arising from synthetic biology basic research and R&D.  It brought together a mix of security policy experts, academic researchers, gene foundry companies, international organizations dealing with biological and law enforcement issues, and NGOs active in the field. It included participants from Brazil, Canada, China (including the Hong Kong Special Administrative Region), Germany, Japan, Malaysia, Pakistan, the United Kingdom and the United States.

The meeting identified a number of future challenges for preventing the misuse of synthetic biology in the future and suggested some courses of action to address them.  In addition, a sidebar meeting with the Chinese participants charted a strategy for creating a national Chinese synthetic biology association and for encouraging Chinese gene foundries to create and implement their own version of a Code of Conduct to ensure that they do not allow their services and products to be misused for nefarious purposes.

These meetings have introduced consideration of the biosafety and biosecurity aspects of synthetic biology to participants from a number of countries with either early stage or plans for synthetic biology programs (namely China, Brazil, Japan, Malaysia and Pakistan) who are in a position to influence the national policy debate in those countries.

 

In addition, the meeting expanded the number of international agencies and intergovernmental organizations involved in this on-going debate, with the inclusion of representatives from INTERPOL, the UN Office of Disarmament Affairs, the Group of Experts that support the Resolution 1540 (2004) Committee and the Organization for the Prohibition of Chemical Weapons.

Syn Bio Meeting Reports