Recommendation 5

Timed Recommendation Risk Assessment Federal Activity

Risk Assessment Review and Field Release Gap Analysis

Identify any gaps in current risk assessment practices related to field release of synthetic organisms.  Identify any differences in methods or strategies between agencies regarding risk assessments.


Because of the difficulty of risk analysis in the face of uncertainty—particularly for low-probability, potentially high-impact events in an emerging field—ongoing assessments will be needed as the field progresses. Regulatory processes should be evaluated and updated, as needed, to ensure that regulators have adequate information. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should convene an interagency process to discuss risk assessment activities, including reasons for differences and strategies for greater harmonization across the government. It should also identify any gaps in current risk assessment practices related to field release of synthetic organisms. These reviews should be completed within 18 months and the results made public.




  • In March 2009, Michael Rodemeyer published a report, New Life, Old Bottles: Regulating First-Generation Products of Synthetic Biology, for the Synthetic Biology Project at the Woodrow Wilson Center.  In the report, Rodemeyer examined the benefits and challenges of using the existing U.S. regulatory framework for biotechnology to cover new products and processes enabled by synthetic biology.
  • In October 2007, the J. Craig Venter Institute, together with the Massachusetts Institute of Technology and the Center for Strategic and International Studies, published a report, Synthetic Genomics: Options for Governance, which addressed the safety and security concerns posed by synthetic biology.  The report assessed the current state of the technology, identified potential risks and benefits to society, and formulated a series of policy options for its governance.   

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