The Presidential Commission for the Study of Bioethical Issues released a report last week that supported continuing research in the emerging field of synthetic biology with some additional federal oversight. President Obama had asked the Commission in May 2010 to study the implications of synthetic biology following the announcement by the J. Craig Venter Institute, a genomic-research organization founded and headed by J. Craig Venter, who helped map the human genome, that his group had successfully constructed the first self-replicating synthetic cell. Venter’s work, while viewed as a scientific accomplishment, has engendered a strong debate on the bioethics of synthetic biology.

Simply speaking, synthetic biology offers both potential and problems. Researchers envision that the knowledge gained by constructing the first self-replicating synthetic cell, coupled with decreasing costs for DNA synthesis, will give rise to wider use of the technology to be applied in developing therapeutic and industrial products such as drugs, vaccines, and biofuels. But there also are misgivings. Some have raised concerns over the deliberate misapplication of synthetic biology as a potential tool in facilitating bioterrorism or see synthetic biology as too novel a science to adequately understand the risks and possible harmful effects that it may pose to human and environmental health.

In issuing its report, the Commission took a middle-of-the-road approach. “We comprehensively reviewed the developing field of synthetic biology to understand both its potential and risks,” said Amy Gutmann, the Commission chair and president of the University of Pennsylvania in a Dec. 16, 2010 Commission press release. “We considered an array of approaches to regulation—from allowed unfettered freedom with minimal oversight and another to prohibiting experiments until they can be ruled completely safe beyond a reasonable doubt. We chose a middle course to maximize public benefits while also safeguarding against risks.”

The Presidential Commission, comprised of 13 scientists, ethicists, and public-policy experts, concluded that while the technical challenges of synthetic biology remain daunting, the field is likely to become more decentralized as relevant tools become increasingly available and affordable. However, although the “Do-It Yourself community has an important role to play in advancing synthetic biology, we recognize that technical challenges and costs are too high right now for completely novel organism to be developed in a non-institutional setting,” said James W. Wagner, the Commission’s vice-chair and president of Emory University, in the Commission’s release. The Commission issued 18 recommendations, including a call for coordinated federal oversight of scientists working in both large institutions and smaller settings.

The Biotechnology Industry Organization (BIO) welcomed the recommendations of the Commission. “It…correctly recognizes that government oversight of this emerging field should foster and promote innovation while practicing prudent viligance,” said Brent Erickson, executive vice-president of BIO’s Industrial and Environmental Section in a Dec. 16 BIO press release. “…[A]dditional regulation in specific areas can be carefully designed and established,” said Erickson. “BIO members organizations are concerned with safety and public perception. Therefore, BIO would endorse the formation of an inter-agency group to help develop strategies and guidelines that would ultimately provide a higher level of safety and security at all levels.”

However, not all agree. More than 50 environmental groups from 22 countries signed a letter to the Presidential Commission and other federal agencies criticizing the findings of the report. The signatories to the letter stress that the precautionary principle should guide synthetic biology regulations. “The precautionary principle must be implemented for the oversight of this new technology whose risks are impossible to predict,” said Andrew Kimbrell, president of the International Center for Technology in a press release. “Once synthetic organisms escape into the environment, they will be impossible to clean up.”

The signatories to the letter are calling for a “moratorium on the release and commercial use of synthetic organisms until a thorough study of all the environmental and socioeconomic impacts of this emerging technology has taken place,” said the letter. “This moratorium should remain in place until extensive public participation and democratic deliberation have occurred on the use and oversight of this technology.”

So are the Presidential Commission’s findings and recommendations good public policy or not? That is hard to say. Synthetic biology is a nascent field, whose practicality has yet to be proven, and whose true risks and rewards have yet to be fully determined. But is that uncertainty a cause to limit its development or perhaps more importantly, can those questions of risk and reward be sufficiently answered without further development? Although the scales of  “prudent vigilance” versus  “precautionary principle” seem to be tipping at the moment to the former, it is in all probability a debate that is only just beginning.