Synthetic biology needs more oversight, and the government needs to put in place regulations specific for this field. That is the bottom line for 111 environmental, watchdog, and other organizations that released a report today with specific recommendations for managing new biological techniques for building and remaking organisms for research and commercial uses ranging from medicines to biofuels.
Calling synthetic biology "an extreme form of genetic engineering," the report said that current practices for regulating and assessing biotechnology were inadequate. The group, which includes the watchdog organizations ETC Group and Friends of the Earth, wants to ban the use of synthetic biology to manipulate the human genome or the genomes of microbes in and on the human body. Full disclosure of the nature of the synthetic organisms and of safety testing should be required to ensure the safety of workers and the environment. Until these regulations are in place, the group wants a moratorium on the release and commercial use of synthetic organisms and their products.
In 2010, a presidential bioethics commission took a close look at synthetic biology and said that no new regulations were required. At that time, ETC and Friends of the Earth joined forces with other organizations to protest the commission's conclusions.
In its report, the commission made 18 recommendations to the federal government, specifying what various agencies needed to do to ensure the safe development of synthetic biology. Last month, the Woodrow Wilson International Center for Scholars in Washington, D.C., issued a scorecard showing how little had been accomplished, despite a June 2012 deadline for seven of the goals. "Based on the [commission's] recommendations, very little has been done," says Todd Kuiken, an environmental scientist at the Woodrow Wilson Center who specializes in synthetic biology. But whether this new report prods the government or industry to action remains to be seen, he points out. "It depends on how the public is engaged with it."
Hillary Wicai Viers, spokesperson for the Presidential Commission for the Study of Bioethical Issues, said the commission considered its synthetic biology efforts just a first step and welcomes this new input. "It's important that views are heard from a wide range of people," she noted in an e-mail.
But Brent Erickson from the Washington, D.C.-based Biotechnology Industry Organization (BIO) calls the report absurd. "[With] the shrillness of its tone and its lack of objectivity, I don't' think it's really helpful to policy-makers and the public." He points out that synthetic biology is in many ways a relabeling and evolution of biotechnology that's been going on for decades. While he agrees that existing rules and regulations may eventually need upgrading, "it's not like we don't have experience in dealing with those organisms," he points out. "There are a lot of safeguards in place."