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.

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. 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', 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.

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.

Reference:
Craig J. Venter Institute: "Synthetic Genomics: Options for
Governance" October 17, 2007.

[biopact.com]