New Policy Report Outlines Options for Governance of Synthetic Genomics

ROCKVILLE, MD, WASHINGTON, DC, and CAMBRIDGE, MA — October 17, 2007 — Policy experts from the J. Craig Venter Institute (JCVI), the Center for Strategic & International Studies (CSIS), and the Massachusetts Institute of Technology (MIT) announced today 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).

For more information about the report and to download a copy, please visit
http://www.jcvi.org/synthetic-genomics-options-governance, http://www.csis.org, or http://web.mit.edu/

J. Craig Venter Institute

The JCVI is a not-for-profit research institute dedicated to the advancement of the science of genomics; the understanding of its implications for society; and communication of those results to the scientific community, the public, and policymakers. Founded by J. Craig Venter, Ph.D., the JCVI is home to approximately 400 scientists and staff with expertise in human and evolutionary biology, genetics, bioinformatics/informatics, information technology, high-throughput DNA sequencing, genomic and environmental policy research, and public education in science and science policy. The legacy organizations of the JCVI are: The Institute for Genomic Research (TIGR), The Center for the Advancement of Genomics (TCAG), the Institute for Biological Energy Alternatives (IBEA), the Joint Technology Center (JTC), and the J. Craig Venter Science Foundation. The JCVI is a 501 (c)(3) organization. For additional information, please visit http://www.JCVI.org.

Center for Strategic & International Studies

CSIS is an independent, nonpartisan policy research organization. It has provided world leaders with strategic insights on — and practical policy solutions to — current and emerging global issues for over 40 years. The Center has extensive experience examining issues at the intersection of science and security, analyzing and mitigating terrorist threats, and combating weapons of mass destruction. The CSIS staff includes more than 120 analysts working to address the changing dynamics of international security and economics. http://www.csis.org

Massachusetts Institute of Technology

MIT is an educational and research university located in Cambridge, Massachusetts. The mission of MIT is to advance knowledge and educate students in science, technology, and other areas of scholarship that will best serve the nation and the world in the 21st century. Its five schools and one college encompass 34 academic departments, divisions, and degree-granting programs, as well as numerous interdisciplinary centers, laboratories, and programs whose work cuts across traditional departmental boundaries. http://web.mit.edu/

Alfred P. Sloan Foundation

Alfred P. Sloan Foundation, a philanthropic nonprofit institution, was established in 1934 by Alfred Pritchard Sloan, Jr., then president and chief executive officer of the General Motors Corporation. The Foundation makes grants in science, technology and the quality of American life. The Foundation's bioterrorism program promotes plans and practices that citizens and organizations can use to defend themselves against terrorism and also supports efforts to monitor dangerous research in the life sciences. http://www.sloan.org

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Contacts

JCVI
Heather Kowalski
cell: 202-294-9206
hkowalski@jcvi.org

CSIS
Neal Urwitz
202-775-3167
nurwitz@csis.org

MIT
Patti Richards
617.253.8923
main: 617.253.2700
prichards@mit.edu

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