The Presidents Bioethics Commission Misses the Mark on Synthetic Biology: Prudent Vigilance a Poor Substitute for Precaution

The Presidents Bioethics Commission Misses the Mark on Synthetic Biology: Prudent Vigilance a Poor Substitute for Precaution

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This article was orginally published by Biopolitical Times, the blog of the Center of Genetics and Society, which offers commentary and news on human biotechnoligies. To learn more, visit

On November 16 and 17, President Obama’s Commission for the Study of Bioethical Issues announced its draft recommendations on the oversight and regulation of synthetic biology. These recommendations were the long awaited response to Craig Venter’s announcement in May 2010 that he and his team had created the world’s first organism with a fully synthetic genome.

The Commission’s study supporting these recommendations, requested by the President after Venter’s announcement, researched the implications of synthetic biology, including potential benefits and risks of the emerging technology. After two public  meetings – one in July and one in September – the commission used its third and final public hearing on synthetic biology to announce and discuss its draft recommendations. The recommendations have not yet been posted officially, but we have transcribed them from the webcast of the November meeting, and are making them available here.

The Commission should be applauded for adopting an open and transparent deliberation process when reviewing synthetic biology. All meetings were open to the public and available as live and archived webcasts. The Commission also intentionally reached out to civil society groups and the public to submit comments throughout its deliberative process.

Nonetheless, the nineteen draft recommendations released in mid-November are far from the precautionary policies needed to protect the environment and public’s health from the novel risks posed by synthetic biology. Instead of looking to the precautionary principle, the Commission coined its own approach to emerging technologies, which it terms “prudent vigilance.” The precautionary principle, which would require that products of synthetic biology are shown to be safe before being released into the environment, has legal precedence in a number of international treaties and conventions, such as the UN Convention on Biological Diversity. “Prudent vigilance,” as described by the Commission, has no legal standing and appears to be not much more than “business-as-usual” with a few soft recommendations to be careful as synthetic biology races forward.

Precaution is necessary in the oversight of synthetic biology because the risks to the environment, public health, and social justice are unknown.  Until the industry can show beyond a reasonable doubt that this technology is safe, it should not be used outside the laboratory.

The Commission asserts that the risks of synthetic biology are theoretical since the technology is still in its infancy, but then goes on to endorse the potential benefits of the clean fuels and life-saving medicines that boosters say synthetic biology will produce as if they were fully developed and on the market already. But they cannot have it both ways. The current and future risks and benefits of synthetic biology must be analyzed before synthetic organisms are released into the environment or used commercially. This would allow policymakers to establish the necessary regulations to ensure that the environment, public health, and social justice are protected and risks are avoided or mitigated. It would also provide time for an open societal discussion about the appropriate and inappropriate uses of synthetic biology before the industry has decided for the public.

Many civil society groups have called for a moratorium on the release and commercial use of synthetic organisms until proper review of their environmental, public health, and socio-economic risks have been done, and until the necessary regulations have been established.

Thankfully, there is still time to comment on these draft recommendations. Email [email protected] and tell the Commission that if we do not properly regulate developments in synthetic biology now it will be too late once synthetic organisms have leaked into the environment.