March 13, 2012 at 7:51 PM ET
More than 100 environmental and social-action groups say synthetic organisms shouldn't be sent out into the world until governments create a new framework to regulate them. Their recommendations for such a framework are outlined in a statement of principles issued today.
Synthetic biology aims to create new genetic strains of microbes, such as algae that are tailor-made to produce biofuels, or bacteria that are engineered to fight medical maladies ranging from infections to cancer. Researchers estimate that the global market for synthetic biology was $1.1 billion in 2010, and is on track to increase to $10.8 billion in 2016.
Critics, however, say that the technology could lead to environmental hazards of Frankensteinian proportions, including new strains of unstoppable invasive species and unpredictable hazards to human health. The 111 groups behind today's statement, including Friends of the Earth, the International Center for Technology Assessment and the ETC Group, are on the critical side of the spectrum.
"We are calling for a global moratorium on the release and commercial use of synthetic organisms until we have established a public interest research agenda, examined alternatives, developed the proper regulations and put into place rigorous biosafety measures," Carolyn Raffensperger, executive director of the Science and Environmental Health Network, said in a news release. "It is our obligation to safeguard the future, to be wise in our development and use of technologies which could threaten humans and the Earth."
The groups call for an outright ban on the use of synthetic biology on the human genome, or on the human microbiome — that is, the wide assortment of microbes that are found inside us or on our skin. They say the current systems in place to regulate genetic engineering are inadequate for the task ahead.
"Self-regulation of the synthetic biology industry simply won't work. Current laws and regulations around biotechnology are outdated and inadequate to deal with the novel risks posed by synthetic biology technologies and their products," said Andy Kimbrell, executive director of the International Center for Technology Assessment.
The debate over synthetic biology has intensified since geneticist J. Craig Venter and his colleagues announced the development of the "first synthetic cell" in 2010. In the wake of that announcement, the Presidential Commission for the Study of Bioethical Issues said there was no need to halt research into synthetic biology or establish an entirely new regulatory framework. Instead, the commission called for a combination of industry self-regulation, closer coordination by existing regulatory agencies and further research into the potential for risk.
When that report was released, the ETC Group's Jim Thomas said it was "disappointingly empty and timid." Thomas' group is one of the principal backers of the proposed principles issued today.
A spokesman for the Biotechnology Industry Organization told ScienceInsider's Elizabeth Pennisi that the principles issued today were not helpful to policymakers or the public, due to "the shrillness of its tone and its lack of objectivity." He said "there are a lot of safeguards in place" today, while acknowledging that the existing regulations may eventually need to be upgraded.
The Woodrow Wilson International Center for Scholars has established its own project to study the policy implications of synthetic biology. One of the leaders of that project, senior research associate Todd Kuiken, told me that the principles issued today were "not that much different" from the presidential commission's recommendations, although he said the tone was a bit more strident. "The word 'moratorium' is a little strong," he said.
"There are potential risks there, and we need to look at these issues before we start putting these things out there," Kuiken said. "I don't think anything they said is that surprising to folks, nor is the response from industry that surprising."
The center's Synthetic Biology Project has voiced concern about the implications of genetic technology for the past 18 months. In a recent Nature commentary, Kuiken and four colleagues urged scientists and officials to take additional steps to avoid "a synthetic-biology disaster."
"Public agencies must link basic and environmental risk research by co-funding projects and requiring grant recipients to work with environmental agencies from the start," they wrote. "Given the complexity of the research questions, the economic and social value of successful synthetic-biology applications and the potential impact of errors, we think that a minimal investment of $20 million to $30 million over 10 years is appropriate."
Today, the Synthetic Biology Project is kicking off an online survey to gauge public opinion on the ethical, legal and social implications synthetic biology. The center said results from the survey would be compiled into a report to be released in May. To take the survey, click here. But first, register your opinion in our own unscientific poll at right.
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