A team lead by SynBERC Practices investigator Ken Oye has produced an updated and expanded version of its Guide to the Regulation of Synthetic Biology in the US & EU. First published in 2010, the guide surveys how existing regulations apply to the emerging field of synthetic biology.

The authors observer that most, but not all, synthetic biology research involves the use of recombinant DNA or synthetic DNA that is identical to DNA from existing organisms. The review treats US and EU regulations governing synthetic biology, the real world implementation of these regulations, and several treaties and agreements to which the US and EU are parties. The concluding section also compares US and EU regulations and discusses future considerations for the regulation of synthetic biology.

When comparing US and European approaches at a high level, the authors note that the EU regulatory framework for approval of genetically engineered products for human consumption or environmental release addresses a broader range of biosafety risks than US rules. By contrast, with respect to biosecurity and synthetic biology, US regulations of exports and domestic activities are more extensive and rigorously enforced than corresponding EU regulations. In practice, however, Oye et al note that the differences between US and EU regulations of health and safety risks of synthetic biology may be more complex than this.

Many regulations described in the paper are in their infancy, and many depend on lists of known dangerous organisms (i.e., select agents). Much regulation attempts to prevent "bad actors" from subverting list‐based controls, yet this could lead to burdensome regulations that impede legitimate research and positive advances in synthetic biology. The authors conclude that the challenge facing regulators is to weigh the costs and benefits of each rule so as to develop an effective and adaptive enforcement system that can evolve along with the living systems that they seek to regulate.