Risk Assessment No Federal Activity
Risk Assessment Prior to Field Release
Reasonable risk assessments should be carried out prior to field release of research organisms or commercial products involving synthetic biology technology. This assessment should include, as appropriate, plans for staging introduction or release from contained laboratory settings.
Recommendation
Reasonable risk assessment should be carried out, under the National Environmental Policy Act or other applicable law, prior to field release of research organisms or commercial products involving synthetic biology technology. This assessment should include, as appropriate, plans for staging introduction or release from contained laboratory settings. Exceptions in limited cases could be considered, for example, in emergency circumstances or following a finding of substantial equivalence to approved products. The gap analysis described in Recommendation 5 should determine whether field release without any risk assessment is permissible and, if so, when.
Activities
Federal
- Agencies under the National Environmental Policy Act
- Environmental Protection Agency – No activities identified.
- Center for Disease Control and Prevention – No activities identified.
- Council on Environmental Quality – No activities identified.
- Office of Surface Mining – No activities identified.
- U.S. Fish and Wildlife Service – No activities identified.
Non-Federal
- In July 2011, the Synthetic Biology Project at the Woodrow Wilson Center held a one-day workshop to test a Comprehensive Environmental Assessment framework for its ability to identify important research questions to support future ecological risk assessments of synthetic biology applications, using a case study of cyanobacteria engineered to produce industrial products. This workshop brought together engineers and ecologists to systematically consider: 1) possible pathways of entry of these cyanobacteria into the environment, 2) what organisms or entities might be exposed, and 3) potential environmental impacts from such exposure. Anticipated products from this workshop will include a report listing priority ecological impacts-related research questions.
- SynBERC published an April 2010 report, The Regulation of Synthetic Biology: A Concise Guide to U.S. Federal Guidelines, Rules and Regulations, which examined the “rules and regulations surrounding the use of synthetic technology, the real‐world interpretation and implementation of these rules and regulations, and future considerations for biosafety in this growing field.”
- Friends of the Earth is working at the federal and international levels to establish a regulatory framework for synthetic biology that has precaution at its core -- one that ensures thorough government analysis of the potential risks and benefits and that puts protections in place before synthetic organisms are used at a commercial scale or make the jump from the lab to our environment.
- The group's 2010 report, Synthetic Solutions to the Climate Crisis: The Dangers of Synthetic Biology for Biofuels Production, addressed concerns with using synthetic biology to develop next-generation fuels.
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