[tt] Venter calls for regs on syn bio - BIO applauds

[Hughes, James J.]

The Report:
http://www.jcvi.org/research/synthetic-genomics-report/media/synthetic-g
enomics-report.pdf

Press release:
http://www.jcvi.org/press/news/news_2007_10_17.php

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/research/synthetic-genomics-report,
http://www.csis.org, or http://web.mit.edu/

http://www.bio.org/news/newsitem.asp?id=2007_1106_01

BIO Welcomes New Report Detailing Policy Options to Ensure Responsible
Use of Synthetic Biology

WASHINGTON, D.C. (November 6, 2007) - The Biotechnology Industry
Organization (BIO) today applauded the report "Synthetic Genomics:
Options for Governance," released by the J. Craig Venter Institute, the
Center for Strategic and International Studies, and the Massachusetts
Institute of Technology. The report assesses the current state of
synthetic biology and formulates policies that can support continued
research and development of beneficial applications and prevent possible
misuses of the technology.

"Synthetic genomics is rapidly expanding the field of industrial
biotechnology research and creating new opportunities to produce
environmentally friendly fuels and biobased products, low-cost chemicals
and pharmaceuticals, as well as new nutritional products and food
ingredients," said Brent Erickson, executive vice president of BIO's
Industrial & Environmental Section. "Industrial biotechnology is the key
enabling technology in the U.S. effort to build a sustainable biobased
economy and to reduce reliance on petroleum."

The findings of the "Synthetic Genomics" report include:

* There are at least 24 companies within the United States and 21 in
other countries - notably Germany and Canada - engaged in commercial
synthesis of gene- and genome-length DNA.

* Improvements in the speed and cost of DNA synthesis are opening the
field of industrial biotechnology to new participants (e.g., engineers
seeking new tools).

* DNA synthesis has already been applied in research on new or improved
drugs - for example, the antimalarial drug artemisinin.

* Synthetic genomics could help produce biological routes to
cost-effective biofuels, including hydrocarbons, and renewable chemical
platforms.

* Biobased manufacturing using genetically enhanced microbes (GEMS) can
produce the raw materials for environmentally friendly products or the
pathways for cleaner methods of production.

Erickson continued, "The industrial biotechnology industry has a very
good record regarding the responsible use of GEMS. The biotech research
community and industry must also take actions to ensure the responsible
conduct of synthetic genomics research. These actions will help maintain
confidence among the public and regulatory authorities that the
advancement of synthetic genomics will be beneficial to society.
Designing ways to impede malicious uses, while at the same time
promoting beneficial uses, of synthetic genomics is critically important
to the development of this technology. This report is a thoughtful and
encouraging step in the right direction."