Guide to US-EU Regulation of synthetic biology Updated and Expanded

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A team from the Synthetic Biology Engineering Research Center (SynBERC), an NSF-funded center headquartered at the University of California at Berkeley, has produced an updated and expanded version of the Guide to the Regulation of Synthetic Biology in the US & EU, which was first published in 2010. The team was lead by Ken Oye, a faculty member at SynBERC partner institution, Massachusetts Institute of Technology, and a SynBERC Practices Investigator.


Most, but not all, synthetic biology research involves the use of recombinant DNA or synthetic DNA that is identical to DNA from existing organisms. Although synthetic biology is a relatively new field, DNA research has been going on for some time and many existing regulations already apply to synthetic biology and its products. Monitoring regulatory changes and needs is necessary in this rapidly changing field. The guide describes how existing regulations apply in the emerging field of synthetic biology by looking at US and EU regulations, real world implementation of these regulations, related treaties and agreements to which the US and EU are parties.


The field of synthetic biology encompasses the design and construction of new biological parts, devices, and systems, as well as the re‐design of existing, natural biological systems for useful purposes. When comparing US and EU regulatory approaches at a high level, the team noted 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, US regulation of exports and domestic activities focus on biosecurity and are more extensive and rigorously enforced than corresponding EU regulations.

The team observed that, in practice, the differences between US and EU regulations pertaining to health and safety risks associated with synthetic biology are probably more complex than they appear. Many regulations 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 team concluded that the challenge facing regulators is to weigh the costs and benefits of each rule to develop an effective and adaptive enforcement system that can evolve along with the living systems that they seek to regulate.