Civil society organizations respond to report on synthetic biology governance

The emerging and controversial field of synthetic biology combines methods for the chemical synthesis of DNA with computational techniques to design it. These methods allow scientists and engineers to construct genetic material that would be impossible to produce using more conventional biotechnological approaches. Using synthetic genomics it is possible to design and assemble chromosomes, genes and gene pathways, and even whole genomes 'from scratch'.

Scientists foresee many potential applications including the design of new pharmaceuticals, microorganisms to fight climate change, and the possibility of rapidly generating vaccines against emerging microbial diseases. The efficient production of next-generation biofuels and bioproducts have been identified as key applications as well. Synthetic organisms promise to open the era of 'endlessly abundant' fuels made from biomass (earlier post, here and here).

As we reported earlier, scientists are weeks away from announcing the creation of the world's first-ever living bacterium with entirely synthetic DNA and a novel genome (previous post). The breakneck speed at which these developments are occuring has awakened civil society, which is very concerned about the potential for misuse of the powerful technology.

Ahead of the announcement, the J. Craig Venter Institute (which developed the organism), the Massachusetts Institute of Technology (MIT) and the Center for Strategic & International Studies (Washington, D.C.) released a report on policy options for the governance of the revolutionary science field. The text is the result of a 20-month examination of the safety and security concerns posed by this new technology, by a core group of 18 experts. "Synthetic Genomics: Options for Governance", assesses the current state of the technology, identifies potential risks and benefits to society, and formulates options for its governance.

However, the ETC Group, an NGO monitoring the responsible use of technology, has heavily criticized the report, which it says focuses too narrowly on security applications. It published its own analysis of the emerging science earlier this year. While the authors of the policy report do acknowledge possible bio-error (i.e., synbio accidents that cause unintended harm to human health and the environment), the emphasis is on how to impede bioterrorists "in a post-September 11 world." ETC Group describes synthetic biology as 'extreme genetic engineering' and calls for a more independent risk analysis and more fundamental questioning. According to the group, the policy report failed to properly consult civil society.

The report is a partial consideration of governance by a partisan group of authors. Its authors are 'Synthusiasts' - or, unabashed synthetic biology boosters - who are primarily concerned about holding down costs and regulatory burdens that could allegedly stymie the rapid development of the new industry. By focusing narrowly on safety and security in a U.S.-centric context, the report conveniently overlooks important questions related to power, control and the economic impacts of synthetic biology. The authors have ignored the first and most basic questions: Is synthetic biology socially acceptable or desirable? Who should decide? Who will control the technology, and what are its potential impacts? - Jim Thomas, ETC Group

The report's authors include representatives from institutions with a vested interest in commercialization of synthetic biology. Scientists from the Venter Institute have already applied for patents on the artificial microbe, dubbed 'Synthia' (previous post), and Craig Venter predicts that it could be the first billion or trillion dollar organism. In this context, the ETC group says the report fails to address issues of ownership, monopoly practices or intellectual property claims arising from synthetic biology:
energy :: sustainability :: biomass :: bioenergy :: biofuels :: climate change :: genomics :: synthetic biology :: bio-error :: bio-terror :: biosafety ::

The economic and technical barriers to synthetic genomics are collapsing, says the ETC group. Using a laptop computer, published gene sequence information and mail-order synthetic DNA, it is becoming routine to construct genes or entire genomes from scratch - including those of lethal pathogens. The tools for DNA synthesis technologies are advancing at break-neck pace - they're becoming cheaper, faster and widely accessible. The authors acknowledge this reality, and evaluate several options for addressing it.

One proposal aimed at 'legitimate users' of the technology - those working in industry labs, for example - is to broaden the responsibilities of Institutional Biosafety Committees, which were established (in the US) to assess the biosafety and environmental risks of proposed recombinant DNA experiments.

Edward Hammond, Director of the Sunshine Project, a biotech and bioweapons watchdog, argues, "Institutional Biosafety Committees are a documented disaster. IBCs aren't up to their existing task of overseeing genetic engineering research, much less ready to absorb new synthetic biology and security mandates. The authors of this report are aware of the abject failure of voluntary compliance by IBCs, including by the Venter Institute's own IBC. So it is very difficult to interpret their suggestion that IBCs oversee synthetic biology as anything but a cynical attempt to avoid effective governance."

Options for governing synthetic biology must not be set by the synthetic biologists themselves - broad societal debate on synbio's wider implications must come first. Synthetic microbes should be treated as dangerous until proven harmless and strong democratic oversight should be mandatory - not optional. Earlier this year the ETC Group recommended a ban on environmental release of de novo synthetic organisms until wide societal debate and strong governance are in place.

ETC and other civil society organizations have called repeatedly for an inclusive, wide ranging public dialogue process on societal implications and oversight options for Synthetic Biology.

Image: M. genitalium, one of the bacteria used in the most advance 'minimal genome' project, which is expected to form the basis of the first artificial life form.

References:
Craig J. Venter Institute: "Synthetic Genomics: Options for Governance" [*.pdf] - October 17, 2007.

ETC Group: Extreme Genetic Engineering - January 2007.

ETC Group: Syns of Omission: Civil Society Organizations Respond to Report on Synthetic Biology Governance from the J. Craig Venter Institute and Alfred P. Sloan Foundation - October 17, 2007.

Biopact: Craig Venter to announce creation of first synthetic life form - October 08, 2007

Biopact: Breakthrough in synthetic biology: scientists synthesize DNA-based memory in yeast cells, guided by mathematical model - September 17, 2007

Biopact: Scientists take major step towards 'synthetic life': first bacterial genome transplantation changing one species to another - June 29, 2007

Biopact: Scientists patent synthetic life - promise for 'endless' biofuels - June 09, 2007

Biopact: Scientists call for global push to advance synthetic biology - biofuels to benefit - June 25, 2007