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Safety & Security

Synberc's Biosafety Program
We have implemented an internal biological safety reporting program by which Synberc researchers declare the expected biosafety level of Synberc supported projects during the annual project proposal phase. Synberc supported projects also include declarations of each project’s institutional protocol approval. Importantly, we are relying on each Synberc institution’s existing biological safety review process to provide local biosafety assessment as required.  

Our efforts in this regard follow the framing provided by the US Recombinant DNA Advisory Committee in which local biosafety review boards, which include both technical experts as well as representatives of the public, should have immediate responsibility for considering issues of safety associated with biotechnology research.  Two Synberc investigators - Ron Weiss of MIT and Drew Endy of Stanford - served as ad hoc members of the Federal Recombinant DNA Advisory Committee to ensure that the new guidelines were comprehensive and practical; we note that these new guidelines finally go into effect March 2013. 

More-Behrens G.H.G., Davis R., and and K.A. Haynes. Preparing Synthetic Biology for the World. Frontiers in Microbiology. 2013. 

Biosafety & Biosecurity within iGEM
Since 2008 Ken Oye has led the organization of a review of all iGEM projects for safety and security risks. For example, in 2012, all 190 iGEM project proposals and safety pages were reviewed by a committee that included international biosafety and biosecurity experts from the UN BWC, Woodrow Wilson Center, DTRA and the Public Health Agency of Canada and a number of other Synberc researchers (e.g., Megan Palmer). This work included follow-up queries to secure more information on projects with apparent or real safety or security issues, resulting in identification of gaps in the implementation of Australia group guidelines, in iGEM processes, and the proper addressing of concerns by iGEM participants. 

Oye K.A., Kuiken T., and P. Millet. iGEM Safety and Security Screening: A Testbed for Addressing Biosecurity Issues. 2012. 


Synberc's Biosafety Educational Resources:

Synberc Biosafety Leadership Experience
Synberc’s BSL Experience is an initiative to encourage Synberc student researchers to take an active role in examining biosafety issues in their own projects and in the broader field of synthetic biology. This project recognizes that safety is a moving target in the context of changing tools, new applications, and new research communities. We are developing a series of video-based educational modules that are designed to inspire and enable a next generation of leaders who can guide the ongoing development, implementation, and promulgation of best practices in biological safety over the next 30+ years. These efforts are being developed in conjunction with the Biosafety Learning Trails, described below, but tailored to the needs of the Synberc community.

Synberc Biosafety Learning Trail (Associated Project)
Chris Anderson is developing an online training module as an 'introduction to biosafety', loosely inspired by Coursera and the UC Berkeley biosafety training programs. It will include video and other content developed for UC Berkeley's iGEM teams and BioE 140L course describing the technical aspects and concerns around biosafety for synthetic biology and additional materials integrated from others in the Practices Thrust. It will also include content about the larger social and ethical aspects of biosafety. The trail discusses these aspects alongside issues of regulation, intellectual property, and the like, though the focus will be issues of real and perceived biosafety risk. The general infrastructure to support this and other Trails is funded through a project associated with the Clotho effort.


Biosafety and Biosecurity Policy and Partnerships
Synberc members and researchers are not practicing biosecurity or law enforcement professionals.  Thus, it would be unreasonable and dangerous to expect that Synberc will solve all questions or concerns regarding biological security.  Practically, we have focused on developing literacy and advancing the framing and discussion of biosecurity needs and opportunities, more broadly.  Beyond the examples noted above, in December 2012 Synberc responded to a FBI request to contribute a summary document detailing how Synberc researchers have and continue to partner with policy and law enforcement agencies to uphold aspects of the Biological and Toxin Weapons Convention (BWC).  Our report was submitted for review by the Departments of Justice and State and will be included as part of the U.S. report to the upcoming BWC Meeting of Experts.  In our contributed report we noted absolutely that the academic and industrial synthetic biology communities require that nations not re-militarize biological technologies, and that partnership with security professionals is essential to mitigate and prevent misuse of biological technologies.

Eichler H.G., Oye K.A. et al. 2012. "Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval," 2012. Nature Clinical Pharmacology & Therapeutics. 2012. 345, p. 426-437. 
Endy D., You, E. and M.J. Palmer. US National Paper to UN Bioweapons Convention Meeting of Experts, August 2013. In Review.
Oye K.A. Proactive and Adaptive Governance of Emerging Risks: DNA Synthesis and Synthetic Biology. Paper presented to International Risk Governance Council, Conference on Public Governance of Emerging Risks, September 14, 2012. Draft accepted by IRGC Working Paper Series.
Oye, K., et al. Managing the Rough Beast:  Biosecurity Regimes and Synthetic Biology. Paper Presented at International Studies Association Convention, April 2012. 


Regulation
Oye K. et al in Schmidt M. (editor), "Regulatory Frameworks for Synthetic Biology," Synthetic Biology: Industrial and Environmental Applications. Wiley, 2012.
Oye K.A., et al. Concise Guide to US and EU Regulations Governing Synthetic Biology. 2012.
Oye K.A. Proactive and Adaptive Governance of Emerging Risks: DNA Synthesis and Synthetic Biology. Paper presented to International Risk Governance Council, Conference on Public Governance of Emerging Risks, September 14, 2012. Draft accepted by IRGC Working Paper Series.