When and How Will We Regulate Synthetic Biology?
Over the past couple of months, there has been a cascade of proposals for — or at least discussions about — regulating synthetic biology, and they are beginning to be noticed. It’s about time!
The technology is edging into the marketplace, at least as proof of concept, and various stakeholders are establishing positions. Some kind of regulation will eventually happen, but we can expect some major struggles first. For instance, if our present institutions are less than adequate to oversee the new processes — and all but the most starry-eyed boosters agree that they are — should they be replaced or expanded? In the U.S. context, what legislation will be required, and how will it get through Congress?
Perhaps most critically, from the point of view of those of us who are skeptical about utopian promises, how can we ensure that social, economic, ethical and other factors are considered? For too long safety has been very narrowly interpreted, and substantial equivalence far too broadly assumed. Will those definitions really be retained when it comes to governing completely novel organisms whose biological and social disruptions are potentially vast, difficult to predict, and perhaps impossible to reverse?
These are not, in practice, questions with simple answers, and some people have been working on them for years. For instance, two of the four authors of the recent Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (discussed below) were co-authors of the 2007 Options for Governance, and one of the others wrote New Life, Old Bottles in 2009. Other previous reports include From Understanding to Action, the self-regulation proposals discussed at Synthetic Biology 2.0 back in 2006, and the much more rigorous Principles for the Oversight of Synthetic Biology proposed by a coalition of NGOs in 2012.
The two most significant of the five reports listed immediately below are those arising from a process undertaken by the international Convention on Biological Diversity, which is soon to resume, and from the federally funded overview produced by a small team led by members of Craig Venter’s organization; both are likely to be sources of discussion for some time to come.