Regulating Industry Uses of Synthetic Biology

The President’s Bioethics Commission, charged with reviewing the field of synthetic biology and identifying appropriate ethical boundaries, advocated prudent vigilance – which balances responsible stewardship of the technology with intellectual freedom for continued investigation – and regulatory parsimony – establishing only as much oversight as is necessary to ensure public safety and public benefits from the technology. They also recommend that regulators have adequate information to conduct risk analysis and harmonization of regulatory standards.

The Science paper concludes that at this early stage of development, synthetic biology does not pose significant novel threats that are fundamentally different from those faced by the biotechnology industry. The regulatory framework that has been shaping recombinant DNA technology for the past 40 years is generally applicable and relevant. In the future, as the technology matures, the need may exist to develop a regulatory framework as overarching federal policy that would be based on existing voluntary regulatory guidelines.