New Policy Report Outlines Options for Governance of Synthetic Genomics

Policy experts from the J. Craig Venter Institute (JCVI), the Center for Strategic & International Studies (CSIS), and the Massachusetts Institute of Technology (MIT) announced the release of a report, “Synthetic Genomics: Options for Governance,” which outlines areas for interventions and policy options to help mitigate potential risks with this promising area of research. The report, funded by a grant from the Alfred P. Sloan Foundation, resulted from 20 months of in-depth study, review and analysis by the teams above and a core group of 14 experts.

Synthetic genomics is a field of research in which scientists use chemically created pieces of DNA (called oligonucleotides or oligos) to design and assemble chromosomes, parts of chromosomes, genes and gene pathways. Scientists foresee many potential positive applications including new pharmaceuticals and biologically produced, green fuels. However, as with many technologies, there is the potential for misuse and accidents.

The core group set out to analyze the state of the technology in synthetic genomics and to develop a comprehensive set of options for policy makers, researchers, and companies in the field. The report includes options that help to enhance biosecurity, foster laboratory safety, and protect the communities and environment outside of laboratories.

“Designing ways to impede malicious uses of the technology while at the same time not impeding, or even promoting beneficial ones, poses a number of policy challenges for all who wish to use or benefit from synthetic genomics” said Michele Garfinkel, policy analyst at JCVI and lead author of the report.

Gerald Epstein, of the CSIS Homeland Security Program and a co-author on the report added, “We have formulated governance options that attempt to reduce security- and safety risks without imposing undue burdens on researchers, industry, or government.”

In addition to Garfinkel and Epstein, the core group was led by Robert M. Friedman of JCVI and Drew Endy of MIT, and convened a series of workshops to hear directly from synthetic genomics researchers, commercial suppliers of synthesized DNA, policy analysts who focus on bioterrorism issues, and those who focus on the legal, ethical, and societal implications of biotechnology.

After these workshops, the group developed a preliminary report and offered this for discussion and input at a public meeting held in Washington, DC for policymakers, the media, non-governmental groups and scientists. These interested parties were also invited to submit comments to the authors for potential inclusion into the final report.

The group identified three areas for policy intervention and outlined policy options for each intervention point. Drew Endy noted, “Our report draws upon the perspectives of many different stakeholders, including developers and users of DNA synthesis technology, as well as the biosecurity community. We hope that our efforts will help ongoing discussions of the responsible use of synthetic genomics techniques and tools.”

The first set of options applies to firms that supply synthetic DNA, both those that supply gene- and genome length strands of DNA and those that supply much shorter oligonucleotides. This set includes the option, for example, that firms must use special software to screen orders for potentially harmful DNA.

The second set of options is aimed at the oversight or regulation of DNA synthesizers and reagents used in synthesis. For example, owners of DNA synthesizers might be required to register their machines, or that licenses might be required in order to purchase specific chemicals needed to synthesize DNA.

The final set of options is aimed exclusively at legitimate users of synthetic genomics technologies. The options cover both the education of users (e.g., modules in university courses that explicitly discuss the risks and best practices when using these new technologies) and prior review of experiments (for example, expanding the roles of institutional biosafety committees to review a broader range of “risky” experiments).