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Synthetic Biology

“Synthetic biology” is a term that represents a collection of extreme forms of genetic engineering.

Synthetic biology practitioners begin with computer-assisted biological engineering to design and attempt to construct new biological organisms or biological building blocks, or to redesign existing biological organisms. Synthetic biologists are not just reading and rearranging genetic code, but writing it. They are re-engineering and designing genes and creating entire genomes that do not exist in nature as well as designing and building molecules and other biological parts and products to desired specifications.

Governments, academics and corporations around the world are racing to develop and commercialize products using synthetic biology. Synthetic biologists have already synthesized working viruses, including the 1918 influenza virus and the poliovirus. In May 2010, the J. Craig Venter Institute announced that its lab had built the first synthetic, self-replicating bacterial cell — that is, researchers inserted a synthetic genome, which did not exactly match the DNA sequence of any natural genome, into an existing working cell; the cell accepted the synthetic genome and reproduced. This technical feat should have been a wake-up call to governments around the world, but little new oversight resulted.

Despite industry claims that these technologies are safe, this technological frontier poses significant health, safety and environmental hazards, as well as profound social, economic and ethical challenges.

The ability to synthesize DNA and create synthetic organisms and products far outpaces our understanding of how these novel products work in the real world. Even engineering supposedly simple organisms could have major ecological and health effects. This unpredictability makes the task of precautionary risk assessment that much more difficult, but also more necessary. Research on the effects of these new technologies and the development of synthetic biology-specific regulations must keep pace with the technologies’ development. Commercializing synthetic biology at this stage is premature.

The standard forms of risk assessment and cost-benefit analyses relied on by current biotechnology regulatory approaches are inadequate to guarantee protection of the public and the environment for current biotechnologies and woefully inadequate for synthetic biology.

The risks of releasing synthetic organisms into the environment — intentionally or unintentionally — have barely begun to be defined, and the urgently needed ethical, legal and regulatory oversight mechanisms have yet to be developed. Without proper safeguards, we risk letting synthetic organisms and their products out of the laboratory with unknown potential to disrupt ecosystems, threaten human health and undermine social, economic and cultural rights.

The International Center for Technology Assessment is working at both the international and U.S. federal level to get sound oversight for synthetic biology.